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0 REPUBLIC OF INDONESIA AGENCY FOR THE ASSESSMENT AND APPLICATION OF TECHNOLOGY BOGOR AGRICULTURAL UNIVERSITY BANDUNG INSTITUTE OF TECHNOLOGY REPUBLIC OF INDONESIA PREPARATORY SURVEY ON NEW ACADEMIC RESEARCH CLUSTER PROJECT IN INDONESIA FINAL REPORT MARCH 2014 JAPAN INTERNATIONAL COOPERATION AGENCY Chiyoda Corporation Mitsubishi Corporation Battelle Japan Nippon Koei Co., Ltd. KRI International Corporation OS JR 14-017

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Page 1: REPUBLIC OF INDONESIA PREPARATORY SURVEY ON NEW ACADEMIC … · NEW ACADEMIC RESEARCH CLUSTER PROJECT IN INDONESIA FINAL REPORT MARCH 2014 JAPAN INTERNATIONAL COOPERATION AGENCY Chiyoda

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REPUBLIC OF INDONESIA AGENCY FOR THE ASSESSMENT AND APPLICATION OF TECHNOLOGY BOGOR AGRICULTURAL UNIVERSITY BANDUNG INSTITUTE OF TECHNOLOGY

REPUBLIC OF INDONESIA PREPARATORY SURVEY

ON NEW ACADEMIC RESEARCH CLUSTER PROJECT

IN

INDONESIA

FINAL REPORT

MARCH 2014

JAPAN INTERNATIONAL COOPERATION AGENCY

Chiyoda Corporation

Mitsubishi Corporation

Battelle Japan

Nippon Koei Co., Ltd.

KRI International Corporation OS

JR

14-017

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Currency Convertion (January 2014)

Exchange Rare: US $1 = JPY 104.71

US$1 = Rp.12,180

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PREPARATORY SURVEY ON

NEW ACADEMIC RESEARCH CLUSTER PROJECT

IN INDONESIA

Draft Final Report

Table of Contents

Table of Contents ............................................................................................................... i

List of Abbreviation ....................................................................................................... viii

Executive Summary ....................................................................................................... xvi

Introduction: Present Situation, Problem Areas and Necessity of New Academic

Research Cluster ............................................................................................................... 1

Chapter 1. Competitiveness Analysis for Indonesian Biocluster and Survey for

Industrialization Promotion ............................................................................................ 14

1.1 Overview ................................................................................................................................... 14

1.1.1 Background on New Academic Research Cluster Project on Bioresources ....................... 14

1.1.2 Why University Research Park Development Matters for Bioresources Development ..... 15

1.2 Competitiveness Analysis for Indonesian Biocluster ................................................................ 18

1.2.1 Pharmaceutical Industry Platform ...................................................................................... 18

1.2.2 Agriculture and Food Platform .......................................................................................... 22

1.2.3 Industrial Bioproducts Platform ......................................................................................... 25

1.3 Survey of High Potential Sector for Research and Investment ................................................. 27

1.3.1 Approach to Informing Identification of Targets of Opportunity for Industrialization ...... 27

1.3.2 Pharmaceutical Industry Platform ...................................................................................... 28

1.3.3 Agriculture and Food Platform .......................................................................................... 34

1.3.4 Industrial Bioproducts Platform ......................................................................................... 37

1.4 Research Subjects ..................................................................................................................... 40

1.4.1 Agency for the Assessment and Application of Technology (BPPT) ................................. 41

1.4.2 Bogor Agricultural University (IPB) .................................................................................. 46

1.4.3 Bandung Institute of Technology (ITB) ............................................................................. 51

1.5 Operation and Management Models for R&D: Best Practices to Inform NARC Activities ..... 57

1.5.1 Stage 1: Awareness and Relationship Building Among and Between Industry and

Academia .................................................................................................................................... 58

1.5.2 Stage 2: Project-driven, One-on-One Industry-University Applied Research and

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Technology Development Mechanisms ...................................................................................... 62

1.5.3 Stage 3: Strategic Partnering to Address a Broad Transformative Initiative ...................... 65

1.6 Commercialization Models: Best Practices to Inform NARC Activities .................................. 70

1.6.1 Importance of Going Beyond Technology Transfer with Complementary Technology .... 70

1.6.2 Incubation Services are Critical ......................................................................................... 72

1.6.3 Incentives for Start-ups and SME Strategy ........................................................................ 73

1.6.4 Proactive Marketing and Outreach..................................................................................... 73

Chapter 2. Information Gathering and Analysis of Existing, Preceding and Similar

Clusters ........................................................................................................................... 75

2.1 Examples of Clusters in Japan, Asia, Europe, and USA ........................................................... 75

2.1.1 Examples of Clusters in Asia ............................................................................................. 75

2.1.2 Example of Biocluster in Japan ....................................................................................... 184

2.1.3 Example of Biocluster in Europe and the US .................................................................. 195

2.2 Investment Trend of Bioindustry Capitals .............................................................................. 198

2.2.1 Investment and R&D Activities Trend of the World in Biopharmaceutical .................... 198

2.2.2 Investment Trend of Japanese Bioindustry Companies and Institutions ......................... 202

2.3 Best Practice of Successful Cluster Development Overview .................................................. 204

2.3.1 Agriculture and Food Oriented Clusters .......................................................................... 205

2.3.2 Biorefining and Biofuels Oriented ................................................................................... 208

2.3.3 Biopharmaceutical Products Oriented Clusters................................................................ 213

2.4 Batam Polytechnic .................................................................................................................. 217

2.4.1 Outline of Batam Polytechnic .......................................................................................... 217

2.4.2 Batam Techno Park .......................................................................................................... 217

Chapter 3. Legal Framework ........................................................................................ 219

3.1 Legal Background ................................................................................................................... 219

3.1.1 Legal Basis of the Project ................................................................................................ 219

3.1.2 Legal Capacity of BPPT and State Universities as NARC Project Implementation

Agencies.................................................................................................................................... 219

3.1.3 Legal Issues on Project Sites ............................................................................................ 223

3.1.4 Other Legal Issues ............................................................................................................ 224

3.1.5 Issues of Current Legal Status ......................................................................................... 225

3.2 Legal Issues on PPP Scheme with Subsidy ............................................................................. 226

3.2.1 Applicability of PPP Regulation ...................................................................................... 226

3.2.2 Legal Issues on PPP Procurement .................................................................................... 227

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3.3 Legal Issues on Hybrid Scheme .............................................................................................. 229

3.3.1 Applicability of PR54/2010 and GR6/2006 ..................................................................... 229

3.3.2 Legal Issues on Hybrid Procurement ............................................................................... 230

3.4 Alternative Legal Basis ........................................................................................................... 231

3.4.1 Joint Venture between Government and Private Entities ................................................. 231

3.4.2 Special Economic Zone (SEZ) Framework ..................................................................... 232

Chapter 4. Incentive Policy .......................................................................................... 235

4.1 Overall Incentive Policy for Research and Industrialization .................................................. 235

4.2 Examples of Incentives in Other Countries ............................................................................ 241

4.2.1 Singapore ......................................................................................................................... 241

4.2.2 South Korea ..................................................................................................................... 244

4.2.3 Taiwan .............................................................................................................................. 245

4.2.4 India ................................................................................................................................. 249

4.3 Examples of Necessary Incentives (Incentives for Start-ups and SME Strategy) .................. 251

4.4 Present Situation of Bioresource Use and Intellectual Property in Indonesia ......................... 258

4.4.1 Present Situation of Bioresource Use in Indonesia .......................................................... 258

4.4.2 Present Situation of Intellectual Property in Indonesia .................................................... 267

4.5 Direction of Incentives from the Viewpoint of Target Market ................................................ 275

4.5.1 Health Products Platform ................................................................................................. 276

4.5.2 Biofuels and Bio-based Chemicals Platform ................................................................... 280

4.5.3 Agriculture and Food Platform ........................................................................................ 281

4.5.4 Responses towards this Platform ..................................................................................... 283

4.6 Considerations of the Incentive Scheme in Indonesia ............................................................ 283

Chapter 5. Demand Creation and Introduction of Company to Indonesia ................... 287

5.1 Examination of the Field of Tenant Target .............................................................................. 287

5.2 Major Research Theme Using Bio Diversity .......................................................................... 288

5.2.1 Study Theme (Using Bio Diversity) of BPPT .................................................................. 288

5.2.2 Study Theme (Using Bio Diversity) of IPB ..................................................................... 290

5.2.3 Study Theme (Using Bio-Diversity) of ITB .................................................................... 295

5.3 Interviews to Enterprises and Search for Possible Tenants Candidates .................................. 298

5.3.1 Preparation and Result Evaluation of Potential Tenants List ........................................... 298

5.3.2 Companies Interview Results........................................................................................... 303

5.4 Marketing Activity through ―BIO JAPAN 2013‖ ................................................................... 307

5.4.1 Outline of ―BIO JAPAN 2013‖ ........................................................................................ 307

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5.4.2 Marketing Activities of JICA Study Team ....................................................................... 308

5.5 Qualitative Market Survey about ―Private Sector‘s Interest to be Involved in NARC‖ ......... 310

5.5.1 About Survey ................................................................................................................... 310

5.5.2 Summary of Results and Fact Findings ........................................................................... 311

5.6 Bio Venture and Small and Middle Enterprises (SMEs) Status in Indonesia.......................... 314

5.6.1 Situations of Bio Ventures and SMEs in Indonesia .......................................................... 314

5.6.2. Policy for Promotion of BioVentures .............................................................................. 314

5.7 Interview Results and Potential Tenant Candidates ................................................................ 316

5.7.1 Possible Tenants for NARC ............................................................................................. 316

5.7.2 Anchor Tenants ................................................................................................................ 316

5.7.3 Demand Risks and Points to Reduce Risks...................................................................... 317

5.7.4 Current situation in Japanese Life science enterprises ..................................................... 319

Chapter 6 Market Forecast ........................................................................................... 321

6.1 Investment Trend for Research and Development of Promising Sector ................................. 321

6.1.1 Life Science Market Trend in the World .......................................................................... 321

6.1.2 Outlook of Japanese Pharmaceutical Manufacturing Industry......................................... 323

6.1.3 Indonesian Health Care Market ....................................................................................... 326

6.2 Analysis on Competitive Position of Indonesian Bio Cluster ................................................. 328

6.2.1 Technological Accumulation in Herbal Medicines .......................................................... 328

6.2.2 Superiority on Vaccination Production in Indonesia ..................................................... 329

6.2.3 Huge Market in Indonesian Food Industry ...................................................................... 330

6.2.4 World Largest Palm Oil Producer .................................................................................... 330

6.2.5 Summary of Indonesian Bio Cluster Superiority Analysis .............................................. 331

6.3 Setting-up of Project Scale ...................................................................................................... 332

6.3.1 Installation Procedure of Project Scale ............................................................................ 332

6.3.2 Incubation Center Configuration ..................................................................................... 332

6.3.3 Estimation of the Number of Researchers in Venture Companies ................................... 334

6.3.4 Study of Research Clusters .............................................................................................. 344

6.3.5 Demand Forecast for Research Center ............................................................................. 348

Chapter 7. Facility Planning, Operation and Project Cost Estimation ......................... 351

7.1. Site Planning .......................................................................................................................... 351

7.1.1 Sites of 3 Counterparts ..................................................................................................... 351

7.1.2 BPPT-NARC .................................................................................................................... 353

7.1.3 IPB-NARC ....................................................................................................................... 355

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7.1.4 ITB-NARC ....................................................................................................................... 360

7.2 Condition for Facility Planning............................................................................................... 362

7.2.1 Standard Room Size ......................................................................................................... 362

7.2.2 Study of Incubation Center Size ...................................................................................... 362

7.2.3 Total Required Area for NARC Laboratories................................................................... 362

7.2.4 Rentable Room and Total Building Area Study ............................................................... 362

7.2.5 Necessity of P2 and P3 level Laboratory ......................................................................... 363

7.3 Preliminary Design ................................................................................................................. 364

7.3.1 Construction Planning ...................................................................................................... 364

7.3.2 Facility Planning .............................................................................................................. 372

7.4 Main Instruments in Common Laboratory .............................................................................. 376

7.5 Unit Price Setting of Land and Rental Laboratory .................................................................. 378

7.5.1 Unit Price of Land Leasing Rate ...................................................................................... 378

7.5.2. Unit Price of Rental Laboratory ...................................................................................... 379

7.6 Operation Planning ................................................................................................................. 380

7.6.1 Biocluster Operation ........................................................................................................ 380

7.6.2 Operating Structure .......................................................................................................... 381

7.6.3 Organization ..................................................................................................................... 381

7.6.4 Policy of Incentives for Tenants ....................................................................................... 384

7.6.5 Tenants Support ................................................................................................................ 386

7.7 Project Cost Estimation........................................................................................................... 388

7.7.1 Cost Estimation of Construction ...................................................................................... 388

7.7.2 Cost Estimation of Operation and Maintenance (Outsourcing) ....................................... 389

7.7.3 Income Estimation of Laboratory Rental Fee and Land Leasing Fee .............................. 394

Chapter 8. Project Structure ......................................................................................... 396

8.1 Basic Project Structure ............................................................................................................ 396

8.1.1 Research Activity Partnership .......................................................................................... 396

8.1.2 NARC Facility Development and Operation ................................................................... 396

8.2 Project Scheme Alternatives ................................................................................................... 398

8.2.1 Alternative 1: PPP Scheme ............................................................................................... 398

8.2.2 Alternative 2: Hybrid Scheme .......................................................................................... 400

8.2.3 Alternative 3: Concession Scheme ................................................................................... 402

8.2.4 Alternative 4: Outsourcing Scheme ................................................................................. 403

8.3 Evaluation of Project Scheme Alternatives ............................................................................. 405

8.3.1 Comparison of Project Scheme Alternatives .................................................................... 405

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8.3.2 PPP Scheme and Hybrid Scheme ..................................................................................... 409

8.4 Role and Responsibilities of Project Partners ......................................................................... 413

8.5 Management of NARC Facilities ............................................................................................ 416

8.5.1 Tenant Relations ............................................................................................................... 416

8.5.2 Profit Sharing for Public Counterparts ............................................................................. 419

8.6 Conclusion and Recommendations on Project Scheme Discussion ........................................ 420

8.7 Stakeholder Analysis ............................................................................................................... 421

8.7.1 Counterpart Organizations (BPPT, IPB and ITB) ............................................................ 421

8.7.2 Financial Conditions of Counterpart Organizations ......................................................... 423

8.7.3 Other Organizations Concerned ....................................................................................... 425

8.8 Implementation Program ........................................................................................................ 427

8.8.1 Innovation Ecosystem as Supreme Implementation Program Target ............................... 427

8.8.2 Biocluster Implementation ............................................................................................... 434

Chapter 9. Financial and Economic Analysis ............................................................... 438

9.1 Methodology ........................................................................................................................... 438

9.2 General Assumptions of the Financial Analysis and Economic Analysis ............................... 439

9.3 Financial Analysis ................................................................................................................... 440

9.3.1 Anticipated Revenue ........................................................................................................ 440

9.3.2 Estimated Expenditure ..................................................................................................... 442

9.3.3 Financing Condition ......................................................................................................... 444

9.3.4 Conditions of Accounting, Tax and Incentives ................................................................ 445

9.3.5 Result of Financial Analysis ............................................................................................ 446

9.3.6 Sensitivity Analysis .......................................................................................................... 448

9.4 Economic Analysis.................................................................................................................. 449

9.4.1 Basic Assumptions Employed for the Analysis ............................................................... 449

9.4.2 Economic Cost of the Project ........................................................................................... 450

9.4.3 Economic Benefit of the Project ...................................................................................... 451

9.4.4 Results of Economic Analysis .......................................................................................... 454

Chapter 10. Risk Analysis and Mitigation Measures ................................................... 460

10.1 Methodology of Risk Analysis .............................................................................................. 460

10.2 Draft Risk Matrix under PPP Scheme and Hybrid Scheme .................................................. 460

10.3 Important Risks and Measures for Risk Mitigation and Reduction ...................................... 461

10.4 Financial Impact of Major Risks ........................................................................................... 464

10.5 Contracts Necessary for Project and Major Contents of Contracts ....................................... 466

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10.5.1 PPP Project ..................................................................................................................... 466

10.5.2 Hybrid Project ................................................................................................................ 468

Chapter 11. Environmental Impact Survey .................................................................. 475

11.1. Regional Characteristic Analysis at 3 Sites .......................................................................... 475

11.1.1 Proposed Site for BPPT-NARC ..................................................................................... 475

11.1.2 IPB-NARC ..................................................................................................................... 478

11.1.3 ITB-NARC ..................................................................................................................... 481

11.2. Examination of the Condition to be Given for Construction and Operation of NARC ....... 484

11.2.1 Preliminary Examination of Possible Environmental and Social Impacts ..................... 484

11.2.2 Scoping of Possible Environmental and Social Impacts ................................................ 485

11.2.3 Required Actions in Further Step ................................................................................... 496

Chapter 12. Implementation Procedure and Schedule.................................................. 510

12.1 Implementation Procedure ................................................................................................ 510

12.1.1 PPP Scheme ................................................................................................................... 510

12.1.2 Hybrid Scheme ............................................................................................................... 513

12.1.3 Comparative Summary .................................................................................................. 515

12.2 Implementation Schedule ...................................................................................................... 516

Chapter 13. Ex-ante Evaluation of Project Effects ....................................................... 519

13.1 Quantitative Effects .............................................................................................................. 519

13.2 Qualitative Effects ................................................................................................................ 520

Appendix ...................................................................................................................... 521

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List of Abbreviation

A*STAR Agency for Science, Technology and Research (Singapore)

AAALAC Association for Assessment and Accreditation of Laboratory Animal Care

International (Taiwan)

ABLE Trade Association for Biotech Industry (India)

AIST National Institute of Advanced Industrial Science and Technology (Japan)

AMDAL Analisis Mengenai Dampak Lingkungan: Environment Impact Assessment

APBN Anggaran Pendapatan dan Belanja Negara (Indonesia)

API Active pharmaceutical ingredients

ASEAN Association of Southeast Asian Nation

AsiaSEED Asia Science Education for Economic Development, Registered Non‐Profit

Organization Asia SEED

ATP Pertamina Advance Technology Division (Indonesia)

BABE Bioavailability & Bioequivalence

BAC PT. Bogor Anggana Cendekia, IPB (Indonesia)

BAKOSURTANAL Badan Informasi Geospasial: National Coordinating Agency for Surveys and

Mapping (Indonesia)

BAPETEN Badan Pengawas Tenaga Nuklir: Nuclear Energy Regulatory Agency

(Indonesia)

BAPPENAS Badan Perencanaan Pembangunan Nasional: National Development

Planning Board (Indonesia)

BATAN Badan Tenaga Nuklir Nasional: National Nuclear Energy Agency

(Indonesia)

Biotech Corp Malaysian Biotechnology Corporation Sdn Bhd

BIOTEK National Biotechnology Executive Board (Malaysia)

BIPP Biotechnology Industry Partnership Program (India)

BIRAC Biotechnology Industry Research Assistance Council (India)

BKPM Badan Koordinasi Penanaman Modal: Indonesian Investment Coordinating

Board

BMS Biomedical Sciences

BOT build-operate-transfer

BPIPO Biotechnology & Pharmaceutical Industries Program (Taiwan)

BPPT Badan Pengkajian dan Penerapan Teknologi: Agency for the Assessment and

Application of Technology (Indonesia)

BRC Biopharmaca Research Center (Indonesia)

BReAD Baking Research and Development Unit, IPB (Indonesia)

BSL Biosafety Level

BSN Badan Standardisasi Nasional: National Standardization Agency (Indonesia)

BSRC Biomedical and Sport Research Center (Indonesia)

BT biotechnology

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BTO build-transfer-operate

BUMD Badan Usaha Milik Daerah (Indonesia)

BUMN Badan Usaha Milik Negara (Indonesia)

CAGR Compound Annual Growth Rate

CCMB Centre for Cellular and Molecular Biology (India)

CED Center for Entrepreneurial Development)Center for Entrepreneurial

Development

CEO Chief Executive Officer

CFD computational fluid dynamics

CFIC Center for Federal Drug Administration and Industry Collaboration

CFTRI Central Food Technology Research Institute (India)

cGMP current Good Manufacturing Practice

CiBOR Center of Innovation for Biomaterials in Orthopedic Research

CIMIT Center for Integration of Medicine & Innovative Technology Technology)

CIO Chief Incubation Officer

CoEs Centers of Excellence

CPI Consumer Price Index

CREATA Center for Research on Engineering Application in Tropical Agriculture, IPB

(Indonesia)

CRI Creative Research Initiative (Korea)

CROs contract research organizations

CRP Competitive Research Program (Singapore)

CSA Clinician Scientist Award (Singapore)

CSIR Council of Scientific and Industrial Research (India)

CTC Centre for Technology Commercialization

DBT Department of Biotechnology (India)

DCB Development Center for Biotechnology (Taiwan)

DEI Development and Expansion Incentive (Singapore)

DEN Dewan Riset National: National Research Board (Indonesia)

DFBO design, finance, build and operate

DHF Design History File

DNA deoxyribonucleic acid

DPR Dewan Perwakilan Rakyat: parliament (Indonesia)

DSCR Debt Service Coverage Ratio

DSI Data Storage Institute (Singapore)

DST Department of Science and Technology (India)

DTD Double Tax Deduction (Singapore)

DTP diphtheria-tetanus-pertussis

ECER East Coast Economic Region (Malaysia)

EDB Economic Development Board (singapore)

EIA environmental impact assessment

EIF European Investment Fund

e-KTP National Electronic ID Card (Indonesia)

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ELSI Ethical, Legal and Social Implications

Equity-IRR Equity-Internal Rate of Return

ERA European Research Area

ESVF Early-Stage Venture Funding Scheme (Singapore)

EWT Environmental and Water Technologies

FDA Food and Drug Administration (US)

FDI Foreign Direct Investment

FIIA Foreign Investment Implementation Authority (India)

FIRR Financial Internal Rate of Return

FMD Facilities Management Department

FTC Fast Track Committee (India)

GCA Government Contracting Agency

GCIC Global Cardiovascular Innovation Center (Cleveland Clinic in the US)

GDP Gross Domestic Product

GDP PPP GDP by Purchasing Power Parity

GIIC Greenland International Industrial Center (GIIC)

GLP Good Laboratory Practice

GMP Good Manufacturing Practice

GPP Geothermal Power Plant

GR Government Regulation (Indonesia)

HBC Herbal Biotech Centre (Malaysia)

HbSAg hepatitis B virus antigen

HBSP Hsinchu Biomedical Science Park (Taiwan)

HepB Hepatitis B

HGB Hak Guna Bangunan: Right for Construction

Hib hepatitis B and Haemophilius influenzae type b

HIV Human Immunodeficiency Virus

HNTE High and New Technology Enterprise (India)

HPI Heartland Plant Innovations

HPLC high performance liquid chromatography

HQ headquarter

HSP Hsinchu Science Park (Taiwan)

HSR-CRGs Health Services Research Competitive Research Grants (Singapore)

IA Investment Allowance (Singapore)

ICRISAT International Crop Research Institute for Semi-arid Tropics (India)

ICT Information and Communication Technology

IDEC Yokohama Industrial Development Corporation (Japan)

IDM Interactive and Digital Media

IDMA Indian Drug Manufacturers Association (India)

IDP Incubator Development Program (Singapore)

IICT Indian Institute of Chemical Technology (India)

IICT Innovation Incubation Centre

IIT Indian Institute of Technology

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ILSC Institute for Life Sciences Centre (India)

IME Institute of Microelectronics (Singapore)

IMRE Institute of Materials Research and Engineering (Singapore)

INSINAS Insentif Riset Sinas (Funding support from the National Research Incentive)

(Indonesia)

INTECH Initiatives in New Technology (Singapore)

IP Intellectual Property

IPB Bogor Agricultural University

IPR Intellectual Property Right

ISO International Organization for Standardization

IT Information Technology

ITB Bandung Institute of Technology

ITTO International Tropical Timber Organization

IVD in vitro diagnostics

Jabodetabek Greater Jakarta: Jakarata, Bogor, Depok, Tanggerang, and Bekasi

JBA Japan Bioindustry Association

JJC Jakarta Japan Club

JNCASR Jawaharlal Nehru Centre for Advanced Scientific Research (India)

JV Joint Venture

KA-ANDAL Kerangka Acuan-Analisis Dampak Lingkungan: TOR for EIA

KABB Kansas Alliance for Bioenergy and Biorefining

KBA Kansas Bioscience Authority

KDDF Korea Drug Development Fund

KIST Korean Institute of Science and Technology

KKPPI Committee on Policy for the Acceleration of Infrastructure Development

(Indonesia)

KOTRA Korea Trade-Investment Promotion Agency

KRIBB Korea Research Institute of Bioscience & Biotechnology

KRW Korean Won

LAN Local Area Network

LAPAN Lembaga Penerbangan dan Antariksa Nasional: National Institute of

Aeronautics and Space (Indonesia)

LAPTIAB Center for Technology for Pharmacy and Medical

LC-MS liquid chromatography-mass spectroscopy

LIPI Lembaga Ilumu Pengetahuan Indonesia: Indonesian Institute of Sciences

LP Lembaga Penelitian: Institute of Research, IPB (Indonesia)

LPM Lembaga Pengabdian Masyarakat: Institute of Community Services, IPB

(Indonesia)

LPPM Lembaga Penelitian dan Pengabdian kepada Masyarakat: Institute of

Research and Community Empowerment of IPB (Indonesia)

MAS Marker Assisted Selection

MEC Ministry of Education and Culture (Kementerian Pendidikan dan

Kebudayaan or Kemdikbud) (Indonesia)

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MEST Ministry of Education, Science and Technology (Korea)

METI Ministry of Economy, Trade and Industry (Japan)

MEXT Ministry of Education, Culture, Sports, Science and Technology (Japan)

MIT Massachusetts Institute of Technology

MKE Ministry of Knowledge Economy (Korea)

MNC's multinational corporation

MOF Ministry of Finance (Indonesia)

MOST Ministry of Science and Technology (Korea)

MOTIE Ministry of Trade and Industry (Korea)

MP3EI Masterplan Percepatan dan Perluasan Pembangunan Ekonomi Indonesia:

Master Plan for the Acceleration and Extension of the Indonesian Economic

Development (Indonesia)

MPA Metropolitan Priority Area (Indonesia)

MRI magnetic resonance imaging

MSC Multimedia Super Corridor (Malaysia)

MSU Michigan State University (US)

NARC The New Academic Research Cluster

NBC National Biotechnology Committee (Singapore)

NBP National Biotechnology Programme (Singapore)

NBP National Biotechnology Policy (Malaysia)

NBRA National Biotechnology Regulatory Authority (India)

NBTB National Biotechnology Board (India)

NCBC North Carolina Biotechnology Center

NCER Northern Corridor Economic Region (Malaysia)

NCP National Contact Point (Russia)

NHRI National Health Research Institutes (Taiwan)

NMITLI New Millennium Indian Technology Leadership Initiative

NMR Nuclear Magnetic Resonance

NPO Nonprofit Organization

NRA National Research Agenda

NRDP National R&D Program (Korea)

NRE National Lab Focused on Renewable Energy (US)

NRF National Research Foundation (Singapore)

NRL National Research Laboratory (Korea)

NSC National Science Council (Taiwan)

NTD New Taiwan Dollar

O&M Operation, Maintenance

OCS Office of Chief Scientist (Israel)

OECD Organisation for Economic Co-operation and Development

OGM Operational Guidelines Manual for The Implementation of Public Private

Partnership in Infrastructure Provision (Indonesia)

OPPI Organization of Pharmaceutical Producers of India (India)

OTF Ohio Third Frontier

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P3K Pusat Penelitian dan Pengembangan Kewirausahaan: Enterpreneurship

Research and Development Center, IPB (Indonesia)

PD Presidential Decree (Indonesia)

PE Precision Engineering

PIC Productivity and Innovation Credit (Singapore)

PIs Principal Investigators (Singapore)

PMK Minister of Finance Regulation (Indonesia)

PMT Project Monitoring Team

PPP Public Private Partnership

PPSHB Pusat Penelitian Sumberdaya Hayati & Bioteknologi: Research Center for

Bioresources and Biotechnology, IPB (Indonesia)

PR Presidential Regulation (Indonesia)

PRTR Pollutant Release and Transfer Register

PSIF Private Sector Investment Finance

PT Perseroan Terbatas (Indonesia)

PT. BLST PT. Bogor Life Science and Technolog, IPB (Indonesia)

PT. PBN PT. Pustaka Bhakti Nusantara, IPB (Indonesia)

PTBH BadanHukum: Legal Entity (Indonesia)

PTBHMN BadanHukumMilik Negara: State-Owned legal Entity (Indonesia)

PTBHP BadanHukumPendidikan: Education Legal Entity (Indonesia)

PTBLU BadanLayananUmum: Public Service Entity (Indonesia)

PTNBH Perguruan Tinggi Negeri Badan Hukum: the autonomy in the form of legal

entity (Indonesia)

PTUPT Unit PelayananTeknis: Technical Implementation Unit (Indonesia)

PUSPIPTEK Pusat Penelitian Ilmu Pengetahuan dan Teknologi

R&D research and development

R&TD Research and Technology Development

RDA R&D Tax Allowance (Singapore)

RIEC Research, Innovation & Enterprise Council (Singapore)

RIS Regional Innovation System

RISC Research Incentive Scheme for Companies (Singapore)

RISE R&D Incentive for Start-up Enterprises (Singapore)

RISTEK Kementerian Riset dan Teknologi: Ministry of Research and Technology

(Indonesia)

RITE Research Institute of Innovative Technology for The Earth

RM Malaysian Ringgit

RNA Ribonucleic acid

Rs India Rupee

S&T Science and Technology

SBIRI scheme Small Business Innovation Research Industry (India)

SBRC Surfactants and Bioenergy Research Center

SCORE Sarawak Corridor of Renewable Energy (Malaysia)

SDC Sabah Development Corridor (Malaysia)

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SEAFAST Southeast Asian Food and Agricultural Science and Technology

SEM scanning electron microscopy

SEZ Special Economic Zone (Indonesia)

SFAz Science Foundation Arizona

SFE Supercritical Fluid Extraction

SIC supra incubation center (Taiwan)

SII Statute for Industrial Innovation (Taiwan)

SIMTech Singapore Institute of Manufacturing Technology

SIRO Scientific & Industrial Research Organizations (India)

SME Small & Medium Sized Enterprise

SPC Special Purpose Company

SPRING Standards, Productivity, and Innovation Board (Singapore)

SPRING SEEDS Startup Enterprise Development Scheme (Singapore)

sq. ft. square feet

sq. m. Square meter

SRG Strategic Research Group

STaR Singapore Translational Research

STEM science, technology, engineering and mathematics

STI Science, Technology and Innovation

STSP Southern Taiwan Science Park (Taiwan)

SUI Statute for Upgrading Industries (Taiwan)

TBP Tuas Biomedical Park (Singapore)

TCR Translational & Clinical Research (Singapore)

TDB Technology Development Board (India)

TECS Technology Enterprise Commercialization Scheme (Singapore)

THRIP Technology and Human Resources for Industry Program

TIBS Training in Biotechnology Scheme (Singapore)

TIDCO Tamil Nadu Industrial Development Corporation Ltd. (India)

TLO Technology Licensing Office

TNPCB Tamil Nadu Pollution Control Board (India)

TPM Technology Park Malaysia Corporation Sdn Bhd (TPM)

TPMB TPM Biotech Sdn Bhd (Malaysia)

TRIPS Agreement on Trade-Related Aspects of Intellectual Property Rights

T-UP Technology for Enterprise Capability Upgrading Initiative (Singapore)

UGM Gajahmada University

UKL Upaya Pengelolaan Lingkungan Hidup: environmental management plan

UN ECLAC United Nations Economic Commission for Latin America and the Caribbean

UNESCO United Nations Organization for Education, Science and Culture

UNIDO United Nations Industrial Development Organization

UPL Upaya Pemantauan Lingkungan Hidup: environmental monitoring plan

VAT value added tax

VC venture capital

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VDI/VDE Verein Deutscher Ingenieure/Verband Deutscher Elektro-techniker: German

Association of Engineers/Association for Electrical, Electronic

&Information Technologies

VGF Viability Gap Fund (Indonesia)

VLP virus -like particles

WACC Weighted Average Cost of Capital

WHO World Health Organization

YBIRD Yokohama Bio Medical R&D (Japan)

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IndustrialBioproducts

AgriFoodProducts

Health Products

BiomassOil cropsStarch andsugar crops

Pharmaingredients

Phytochemicals

Functional food

Biofuels

Bio-based chemicals

Vaccines

Diagnostics

Herbal medicines

BiopharmaceuticalsValue-added food

Enhanced and new crops

Soil enhancement

Analog foods

Executive Summary

Competitiveness Analysis and Survey for Industrialization Promotion

NARC on Bioresources offers significant industry development platforms for advancing

targeted opportunities for industrialization in Indonesia around university-associated research

parks. In order to gain the maximum impact of the resources invested as well as to clearly

define to industrial partners the value of NARC research parks, it is recommended that particular

attention be given to fostering ―Signature Platforms‖ in key areas of industrial bioscience. It is

anticipated that the developed facilities would facilitate joint research projects between

the research institutions and industry, be able to house industry research operations,

incubate new business ventures based on commercializable technology, and encourage

the growth of a research park environment. Three key Signature Platforms stand out as

high potential sectors for advancing the development of industry collaborations around the new

academic research clusters in bioresources for Indonesia:

-Pharmaceutical platform involving bioprospecting for natural products and herbal

medicines; the production of diagnostics, vaccines and antibiotics; and pharmaceutical raw

materials.

-Agriculture and Food platform involving primary agricultural improvement and

diversification as well as value added food products.

-Industrial bioproducts platform focused on bio-oils, biofuels and biorefining operations

with a particular emphasis on adding-value to palm oil as a principal feedstock.

Bioresource Core Competency Platforms for Indonesia

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As shown in the figure above, each platform provides opportunities for R&D-driven development in

a distinctive set of potential products. However, there is also considerable synergistic overlap

between the platforms, as indicated in the Venn diagram intersections.

Proposed Actions to Advance NARC Industrialization Promotion

Analysis of Indonesia‘s industry position across the industry areas and their associated market

niches leads to a focused set of proposed activities have been identified in consultation with the

three NARC institutions for bioresources. The table below presents the key development

challenges confronting Indonesia in each of the target markets and the proposed actions for the

NARC.

Target

Industry

Platform

Target Market Key Challenges for Indonesia Proposed Actions for NARC

Ph

arm

aceu

tica

l In

du

stry

Pla

tfo

rm

Herbal Medicines

Reaching significant scale in

identification and assessment of herbal

medicines

Improving quality standards in line

with ASEAN harmonization

Increased analytical lab capacity for

identifying and characterizing bio-active

ingredients

More rigorous efficacy studies involving

high-throughput laboratory-based in vitro

studies as well as human-based clinical

studies

Longer term -- Increased synthetic

chemistry capabilities to advance natural

product drug discovery and development

Bio-pharmaceuticals

for Diagnostics,

Vaccines and

Antibiotics

Growing focus on biologics for drug

treatment

Shift to more complex biosimilar

production in generics

Address need for increased capacity for

bio-scale-up facilities and expertise

Offer incentives to further partnerships

with foreign biopharmaceutical

companies at NARC sites – including

relaxation of foreign ownership limits

Pharmaceutical Raw

Materials

More than 90% of raw materials used

to manufacture generic drugs in

Indonesia are imported – so value

added and wealth creation in Indonesia

is low

Very competitive global industry

Increased government R&D funding to

advance competitive advantages for

Indonesia through development of novel

active pharmaceutical ingredients,

innovative formulation technologies or

novel drug delivery methods

Ag

ricu

ltu

re a

nd

Fo

od

Pla

tfo

rm

Agricultural

Improvement &

Diversification

Raising agricultural productivity

Addressing environmental challenges

of soil erosion and climate change

Improved facilities to advance plant

breeding and seed development for

improved and diversified crops

Supporting growing tropical fruits

markets for export growth – improve

post-harvest technology, food safety, pest

and disease control

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Target

Industry

Platform

Target Market Key Challenges for Indonesia Proposed Actions for NARC

Value Added Food

Products

Having local industry keep pace with

growing local demand for healthier

foods

Need for specialized laboratory equipment

as well as scale-up processing

technologies to characterize, separate,

purify and process bio-active chemicals in

crops and developing new

health-promoting food products

Indu

stri

al

Bio

pro

du

cts

Pla

tfo

rm

Palm Oil Bioproducts

Increase value-added activities in

Indonesia beyond milling stage to

generate higher production value

across the full range of bioproduct

development opportunities

Enhance yields of palm oil in

Indonesia

Pilot broader processing of palm oil within

Indonesia

Increase yields through improved

agronomy, fertilizer usage and improved

plant varieties of palm trees

Consider testing and validation facilities

The NARC program envisions investing in the development of Signature Platforms at each

institution focused on applied research and technology commercialization with industry partners.

By providing such unique capabilities, innovation and societal benefit can be accelerated in

support of regional and national the goals.

Legal Framework

Legal Basis of the Project

Since many of Research and Development (R&D) activities are not profitable, the government

supports/incentives are inevitable to promote R&D activities. Therefore, it is important to select

the legal basis which makes it possible for government to provide supports/incentives for the

development/construction of R&D facilities. JICA Study Team proposed two project scheme

alternatives. One is the PPP Scheme with government subsidy and another is Hybrid Scheme

which is the combination of public private investment. The legal basis for the above-mentioned

two project schemes alternatives are as follows:

(1) PPP scheme, based on the Presidential Regulation (―PR‖) No.67 of 2005 (which has been

amended by PR No.13 of 2010 and PR No.56 of 2011),

(2) Hybrid scheme, Presidential Regulation No.54 year 2010 on Government Procurement of

Goods/Services and Government Regulation No.6 year 2006 on State/Regional Assets

Management.

Legal Capacity of BPPT and State Universities as NARC Project Implementation

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Agencies

The current PR67/2005(PPP scheme) does not prescribe state university as a Government

Contracting Agency (GCA) for PPP project. If the state university cannot be a GCA, BPPT shall

be the only one GCA under PPP regulation. In this case, the right and obligation of the project

would be shared only between BPPT and SPC under PPP contract. Separately from PPP contract,

BPPT would share the right and obligation with state universities based on the cooperation

agreement. On the contrary, both BPPT and Universities can be a GCG under Hybrid scheme.

Legal Issues on Project Sites

The land of NARC BPPT site is owned by the State. Regarding to the interview to BPPT, the

right to use the land is hold by RISTEK and shall be transferred to BPPT and/or a private

company. RISTEK need prior approval from MOF for the contribution of the land to a private

company. NARC IPB site is owned by the State and IPB is given the right to use the land. IPB

also need prior approval from MOF for the contribution of the land to a private company.

In terms of ITB, the ownership of the land where NARC project is proposed to be conducted is

currently under Bekasi Regency. Bekasi Regency and ITB had the agreement, ―Cooperation

Agreement between Government of Bekasi District and Bandung Institute of Technology about

ITB Campus Development and Education Development Activities, Training Research and

Community Social Responsibility in Bekasi District (Bekasi-ITB Agreement) and ITB shall be

given the right to use the land of Bekasi Regency based on the Bekasi-ITB Agreement.

Bekasi-ITB Agreement prescribes that Bekasi Regency shall hand over the management of land

and building to ITB for the purpose of educational development activities, training research and

community service in Bekasi. However, it does not prescribe about sub-leasing the land to the

third parties. In order for a private company to use the land, Bekasi-ITB Agreements should be

amended before the procurement process would start.

Also, Bekasi-ITB Agreement prescribes that the ownership of the building on the land which

Bekasi lend to ITB shall be transferred to Bekasi Regency. If the NARC facility were owned by

Bekasi Regency, it would be difficult to set the collateral on the NARC facility, which makes

difficult for the private business entity to get finance. ITB need to amend Bekasi-ITB

Agreements in this issue as well to keep the ownership of NARC for the private business entity

during the project period.

Legal Issues on PPP Scheme with Subsidy

PR 67/2005 does not prescribe ―Infrastructure for Innovation and R&D activity‖ as its targeted

infrastructure. Based on the legal review, the list of infrastructures prescribed in PPP regulation

is not conclusive. However, it commented that Ministry of Finance most likely would not

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provide VGF unless ―Infrastructure for Innovation and R&D activity‖ would be listed in PR

67/20051. BPPT supported by JICA Study Team prepared the Amendment Proposal to KKPPI

and submitted it to KKPPI. BPPT and Study Team were informed that the concerned

government ministries are currently collecting information for the amendment of PR67/2005.

The actual amendment of PR 67/2005 is scheduled in 2014.

Legal Issues on Hybrid Scheme

In order to implement Hybrid scheme in the project, mainly two types of contracts need to be

made; one is EPC contract for the construction of Incubation and Support Center and another is

BOT contract for DBFO of Research Center (including design of Incubation and Support

Center). It seems to be no legal obstacle for this EPC procurement.

On the other hand, GR6/2006 allows the utilization of state or regional government property for

private as BOT scheme with the following condition.

- The facility which private develop shall provide the public services

- Not funds are provided from State and Regional government‘s budget.

Since the BOT contract of Research Center would provide public services and would not use

require public budget, it would clear the above-mentioned conditions. Also no other major legal

obstacles are found.

(1) Budgeting for Construction of Incubation Center and Support Center

For the hybrid Scheme, not only BPPT but also IPB and ITB can be GCA. If the all parties above

have a role of GCA, each party needs to apply for the budgeting of construction of Incubation

Center and Research Center. If only BPPT would have the role of GCA, only BPPT would apply

for the budget for the construction of above-mentioned facilities. In this case, the assets funded

by APBN (using BPPT‘s budget) will become the State assets (barang milik negara) registered

under BPPT‘s name as the asset user (pengguna barang).

(2) Budgeting for Non-academic Facility for Universities

IPB and ITB (with its status as PTBH) are allowed to propose for funding from APBN for the

implementation of higher education. However, there is no express provision for funding for

non-academic purposes (although generally IPB and ITB are allowed to conduct investment

with commercial motive). It is assumed that IPB and ITB are allowed to propose for APBN

support for its investment as long as the program is approved in the APBN discussion. If the

1 See APPENDIX 3-1 for the Legal Review by HJ.

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investment by IPB and ITB is using the funding from APBN, then the procurement of the goods

and services must follow PR 54/2010 (as amended).

(3) Joint Procurement

In elucidation of PR 54/2010, the joint procurement contract is conducted in order to implement

goods/service procurement, which fund originated from several ministries, government agencies

(BPPT), regional government, government institution (IPB and ITB), with different source of

funds. PR 54/2010 states that the responsibilities for budget in joint procurement contract, is to

be regulated in a certain joint funding agreement between the parties.

(4) Possibility of B to B Contract between GCA and the Private

There is a question if BPPT and Universities can have Business to Business contract for the

Research Center since there is no subsidy injection. On the assumption that the land constitutes

"State assets" or "region‘s assets" (i.e. land owned by the state or by regional government), then

BPPT/IPB/ITB cannot establish business to business contract for BOT of the research center as

well as O&M.

Incentive Policy

Current Incentive Laws and Regulations for R&D

The following table shows the list of laws and regulations regarding to incentives for R&D in

Indonesia.

Laws/Regulations Numbers Covered Area Outline of Incentives

Law of Government of Indonesia No

18 of 2002

National system of research,

development and application of

science and technology

Tax relief, risk mitigation, rewards

and recognition, or other incentives

that can encourage funding for R&D

activities

Government Regulation No. 35 year

2007

Allocating some portion of revenue

of business entities to improve the

capability of engineering, innovation

and technology diffusion

Tax incentive, customs, and/ or

technical assistance for R&D

Law of Government of Indonesia

No. 36 of 2008

Income Tax Gross income deduction for R&D

activities costs

Government Regulation No. 93 of

2010

Donation for national disaster,

donation for research and

development, donation for education

facility, donation for sport coaching,

and social infrastructure

development cost which are

deductible from gross income

Gross income deduction for donation

for R&D activities

Government Regulation No. 52 of Income tax incentive for capital Reduction in net income by 30% of

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2011 investment in certain areas and / or

certain regions (1st amendment

Government Regulation No. 62 of

2008, 2nd amendment of Government

Regulation No. 1 of 2007)

the capital investment, charged for 6

years respectively by 5% per years;

Acceleration of depreciation and

amortization imposition of income

tax on dividends paid to foreign tax

subject by 10%, or a lower rate

under the applicable agreement of

double taxation avoidance losses

compensation for longer than 5 years

but not more than 10 years .

Minister of Research and

Technology of Republic of

Indonesia Regulation No. 1 of 2012

Technical assistance for research and

development to business entities

Placement of experts, and / or

utilization of laboratory facilities in

R & D institutions

SEZ

There are several facilities in the SEZ that can be enjoyed by investor or business entity which

conduct business activities. Every taxpayer which conducts business activities in the SEZ will

get facility of income tax and also can be added in accordance with zone characteristics. Tax

facility also may give to the investor in certain period in the form of reduction of building tax.

Import of goods to SEZ may get facilities in the form of:

(1) Suspension of import duties

(2) Exemption of tax, to the extent such goods are raw materials and production supporting

materials

(3) Exemption of value added tax or sales tax on luxury goods for taxable goods

(4) No admission for import income tax

In addition, every taxpayer which conducts business activities in SEZ may be given incentives in

the forms of exemption or reduction of regional tax and tax retribution in accordance with laws

and regulations in tax. However, it necessary to have discussion and negotiation with the

relevant government authorities, such as Ministry of Finance for the fiscal incentives and Local

Government for the simplify procedures, by each SEZ executing organization separately.

Since no platform for the figures on listed possible incentives above, the actual incentives in

surrounding countries below may be utilized as a reference for the negotiation.

Considerations of the Incentive Scheme in Indonesia

In order to attract industries to conduct R&D in Indonesia, it is important to have incentives such

as tax deduction. It is more important to know the current incentive setups for R&D activity of

neighboring countries than other area of the world since neighboring counties would be major

competitors for Indonesian R&D business.

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JICA Study Team selected Singapore, Malaysia, and Taiwan for comparative analysis to know if

there is comparative advantage in terms of incentives for R&D activities in Indonesia (See the

table below). JICA Study Team found there is various types of incentives for R&D in

neighboring counties not only tax incentives but also grant/subsidy type of government support,

fund for R&D and so on. Especially it is critical that grant/subsidy type incentive for R&D

activity is missing in Indonesia while neighboring countries provide various types of

grant/subsidy for R&D.

Singapore Malaysia Taiwan Indonesia

Tax Incentive e.g. 150% of R&D

expenditure can be

deducted

e.g. 100% of capital

expenditure for R&D can

be deducted within 10

years. In-house R&D can

claim 200% super

deductions for

non-capital expenditures

e.g.35% of taxable

income within 5 years

e.g.100% of R&D

expenditure can be

deducted

Grant/Subsidy e.g. Cash grant of up to

S$20,250 for at least

S$150,000 worth of

qualifying R&D

expenses during the

first 3 years of start-up

activities

e.g. Exploratory

Research Grant Scheme

for Explore new ideas &

concepts catalyst for new

discoveries & inventions

-Prototype Research

Grant Scheme for

research for product

development prior to

commercial launch

e.g. Subsidies 50% of

research budget for

Small Business

Innovation Research

-Subsidies to the

set-up of R&D centers

by multinational

corporations up to

NT$5 million each

year, and 50% of the

research budget

e.g. Research of

National Innovation

System (more than

Rp 500 million per

year per proposal)

Patent , Fund,

Human

Resources

e.g Deduction of patent

registration fees.

-Training allowance for

5-year in-employment

PE training program.

Relevant to med-tech

companies

e.g Techno Fund to

develop products &

technologies for

pre-commercialization

stage Max: $1.6Million

Pilot scale production

e.g. A Science Park

tenant company can

apply to the Division

of Business Services

of the Science Park

Administration to

issue new stocks

regarding innovative

technology

know-how‘s.

e.g. Technical

assistance by

placing the experts

and utilizing

laboratory facilities

in R&D institution

To bring the R&D activities of the world class technology and science industries in Indonesia

would give enormous impact for the development of Indonesian economy. However, the current

incentive system does not have enough comparative advantage among neighboring countries.

JICA Study Team recommends establishing the following incentive policies.

Proposal based on the Comparison of Incentive Policies among Neighboring Countries

(1) Creation of Grant/Subsidy type incentives for R&D activity

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The neighboring counties have various types of grant/subsidy incentive policy for R&D

activities. In order to compete with those neighboring counties, JICA Study Team recommends

the Government of Indonesia (GOI) to consider establishing more grant/subsidy type incentives

for domestic and international companies especially for NARC users whose R&D is approved

by GOI as strategically important for industrial development of Indonesia. This role might be

initiated by RISTEK.

(2) Stronger Tax Incentives at least to the level of Singapore and Malaysia

The current tax incentive policy of Indonesia is still less competitive comparing Singapore and

Malaysia. JICA Study Team recommends GOI to increase the level of tax incentive at least to the

level of Singapore and Malaysia which allow deducting 150-200% of R&D expenditure. It is

also provide strong incentives to R&D industries if tax is exempted for the initial several years of

operation for NARC users. This role might be initiated by Ministry of Finance.

Proposals for Incentivizing by Using Comparative Advantage of Indonesia

(1) Privilege for Utilization of Biodiversity Natural Resources in Indonesia

Current Indonesian policy for bio resource is biased for protection and giving impression of

closed for the utilization of bio resources, which make international firms hesitate for initiating

R&D activity utilizing biodiversity in Indonesia. Therefore, it is important to shift the policy

direction to utilize bio resources more actively. By permitting the domestic and international

firms using NARC facility to utilize bio resources not only for research purpose but also for

subsequence commercial purpose, it would provide tremendous incentives for high technology

and science oriented firm to utilize NARC facilities for their R&D activities. This role might be

initiated by RISTEK.

(2) Incentive for Commercializing Research Output originated from NARC

Having co-research with Indonesian public research institutions (BPPT, IPB and ITB) and

private firm and sharing intellectual property right among those parties in NARC, the incentives

should be also provided even it moves from research stage to commercial stage as long as the

project still sustain the conditions for receiving incentives during R&D. In other words, if the

privilege such as tax reduction would be given even after the commercial stage by utilizing the

result of NRAC‘s co-research output, the private firm who is currently considering only the

construction of production line in Indonesia may seek the opportunity for R&D activity as well.

This role might be initiated by MOF.

Demand Creation and Introduction to NARC

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Demand Creation and Introduction to NARC have been conducted through several ways; (1)

Clients List of Chiyoda Corp. and Mitsubishi Corp., (2) Interview in Indonesia done by JICA

Study Team and Counterparts, (3) Business Matching Talk at the ―Bio Japan 2013,‖ and (4)

Local market survey by local consultants in Indonesian.

In interviews, future research theme, request on NARC, possibility of participation were asked

to possible tenants companies. Through interviews, about ten companies in Japan and about 30

companies in Indonesia showed their interest to NARC respectively, even though incentives and

government policies were not clear when interviewing.

Policy for Promotion of Bio Ventures

In Indonesia, policies for bio venture promotion are not enough, nor SMEs promotion. Although

in Japan, recognition of bio venture promotion is not high, the METI is the main governmental

organization to promote creation of venture enterprises and provision of development policy as

follows:.

- Fund for ventures by SME promotion agency

- Funding by Industrial innovation agency

- Angel taxation

- Fund taxation for overseas investors

- Supporting technology development and trial manufacturing by the New Energy and

Industrial Technology Development Organization (NEDO)

Local governments in Japan provide various menus for supporting venture enterprises.

Demand Risks and Plans to Minimize the Risks

(1) Bio Diversity

Research theme done by Indonesian universities and institutes are studied and summarized in the

chapters of this report. In actuality, however, bio diversity is not utilized enough as yet. In

Nagoya protocol, bio resources are prohibited to move in and out of the countries. In NARC

project, utilization and offering of bio diversity is expected to be approved. Many universities

and companies outside Indonesia are expecting to do research and to make products, and finally

to export these products to ASEAN markets.

(2) Largest Market in Islamic Regions

Indonesia has more than 200 million populations which is the largest market in ASEAN region.

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The market is also the largest among Islamic regions. In Indonesia, foods are processed

according to halal rules. It is possible to expand their market of food and pharmaceuticals to

other Islamic regions.

(3) Collaboration of Industrial and Academic Fields in Research, Product Development and

Production

Major Indonesian pharmaceutical and food enterprises have already collaborated with

universities that have interests in collaboration for products development and production.

However, SMEs of pharmaceutical, food and energy companies except a part of major

companies do not generally have recognition of importance for academic and industrial

collaboration.

(4) Competitive Position of Indonesian Bio Cluster

The competitive positions of Indonesian Bio Cluster are summarized as follows:

- Indonesia is the largest exporter of palm oil in the world. In addition, from now on, many

kind of new products development of palm oil and varieties of production activities are

expected.

- Human resources from BPPT, IPB and ITB are provided to NARC project.

- As Indonesian market is the largest ASEAN countries, big profits are promised if succeeded

in Indonesia.

- NARC becomes a bridge or networking between Japan and Indonesian companies and

universities. They want expand business development. Especially Indonesian companies

want to collaborate with Japanese companies to introduce Japanese technologies and to

expand their market.

(5) Fulfillment of Incentives

Incentives for tenants must be fulfilled with possible tenant requests. One Japanese possible

tenant needs an experimental farm and another needs a big pond for cultivation of fish. For the

purpose of inviting many possible tenants, it is necessary not only to provide incubation and

research center, but also to consider individual requests of possible tenants.

Requests on NARC from Potential Tenants Companies

-Many of companies demand subsidy of research fund and incentive even including Japanese

companies.

-Some Japanese and Indonesian Companies want to collaborate each other.

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-Japanese Pharmaceutical Companies : Conduct ‖ Clinical study‖ in Indonesia.

-The importance of training opportunity and training center, human resource development

-Recruiting Professional Researchers & Engineers

-Dormitory, Experimental Animal Supply Center, High quality Water and Electricity

-Production Facility first, Expansion and R&D secondary in especially Japanese large

pharmaceutical companies

-Some companies demand the importance of Support Center in terms of Patent Management

and Preservation IP (By Japanese Companies strongly) and Quality Control Center ( By

Indonesian companies)

To prepare “Action Plan” to Gather More Possible Tenants for Long Term Basis

(1) To disseminate NARC to Indonesian and other countries enterprises

-Press Release & Seminar for NARC Dissemination

-Maximum utilization of domestic bio-industry conferences and exhibitions

-Participation into international conferences and exhibitions (including Taiwan, Singapore

and Japan, etc.): Poster session, Writing articles, Request related persons to introduce NARC

-Continuation of individual interviews, company by company basis

(2) To clarify attitude and policy of Indonesian governmental support on bio-industry (same as

Singapore, Taiwan and Japan, etc.)

(3) To provide ―Incentives‖ to attract tenants in the forms of tenants oriented

(4) New Matching System: To collect partners effectively

-Possible to co-research and co-development with national institutes, universities and

companies (Indonesian and Japanese Enterprises want collaboration each other)

Market Forecast

World Pharmaceutical Market

Growth rate of world Pharmaceutical Market was: 6.7%(2007~2011) by following reasons;

- Increase of aged population

- Increase of chronic disease

- Increase of market opportunity in developing countries

- Medical-payment system reform

Japanese Pharmaceutical Market

As Japanese government has put in stress into reduction of medical care budget in terms of

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preventive medical care, promotion of generic medicines, etc., growth in Japanese market will

not be expected. However, Japanese market has following stand point;

- Japanese Market Share: NO.2 of the world market

- New Medicine Development: Ranked 3rd ( US, UK, Japan, Switzerland…)

Indonesian Market

(1)Pharmaceutical Market in Indonesia

Market researches show that the overall pharmaceutical market in Indonesia has reached US$ 5

to 6 billion in 2012 and the size of the market is expected to grow at the rates of 7.6% to 9.0%

annually over the next 5 to 7 years. In 2012, each share of generic prescription drugs and

over-the-counter medicines was approximately 40% of the total pharmaceutical market.

The remaining 20% of the Indonesian pharmaceutical market in 2012 was comprised of patented

prescription drugs.

(2)Food Market

In the food and the beverage market of Indonesia, the increase of market continues by income

increase accompanying national economic growth. A processed food and soft drink market are

especially fast-growing. In the processed food and the soft drink market, although the major

local food companies are maintaining the first place, major foreign companies, such as Nestle

which has marched out for many years, have also secured the fixed position.

- Process Food Market: US$20 Billion in 2010

(3) Bio Diesel Market in Indonesia

Indonesia‘s biodiesel sector maintained a healthy growth in 2012. Biodiesel production

increased from 1.575 billion liters in 2011 to 2.2 billion liters in 2012. Exports of biodiesel

registered a strong export growth of 22 percent from 1.225 billion liters in 2011 to 1.5 billion

liters in 2012 – with nearly 90% being exported to Europe. World production of palm oil is

expected to increase by 32% to approximately 60 million tonnes by 2020.

Analysis on Competitive Position of Indonesian Biocluster

Following items are competitive position of Indonesian biocluster.

-Technological Accumulation in Herbal Medicines

-Superiority on Vaccination Production in Indonesia

-Huge Market in Indonesian Food Industry

-World Largest Palm Oil Producer

Furthermore, Indonesia has following competitive and superiority points;

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-Marketability: the Indonesian market with future economic growth or population of 200

million have a big predominance in comparison with foreign countries, and its market is

attractive.

-Human Resources: although in Indonesia, cheaper labor force is available, bio-industry is not

a labor intensive one and needs skilled labors, engineers, etc. In order to secure human

resources, the talented people from BPPT, IPB and ITB, and graduates from the universities

can be provided.

-Cluster location: Those planned site are a big market, Jakarta as hinterland.

BPPT in Serpong, IPB in Bogor and Deltamas of ITB

Facility Planning, Operation and Project Cost Estimation

Action to be taken by Indonesia and/or Japan concerning with facility planning

(1) To decide the site for NARC Facility by coordinating with concerned authorities

(2) To agree with Ministry of Finance on the land use for NARC Facility

(3) To proceed to move peoples using proposed land as farming, stock farming and etc.

(4) To coordinate among stakeholders in the proposed sites for NARC Facility

(5) To plan the construction of approach road in budget and time schedule

(6) To confirm the capability and present connecting points for infrastructure

(Electricity, Water, Swage, Communication and etc)

(7) To coordinate laws and proceedings in related government, regency and aviation

(8) To take countermeasure on any risk of construction with monitoring

(9) To consider expansion of research center site when the demand is increased

Consideration of Facility Planning

(1) Location

The candidate site of BPPT-NARC is located at PUSPITEK in Serpong, Tangerang, Banten, and

has 27.3ha. The candidate site of IPB-NARC is located at Dramaga Campus in Bogor West Java,

and has 10.8ha. The candidate site of ITB-NARC is located at Delta Mas Industrial Park, Bekasi

West Java, and has 40.0ha.

(2) Design Concept

1) To design facilities in eco-friendly consideration with earth environment and surrounding

landscape (eco-friendly)

2) To design facility considering fusion of Indonesian and Japanese joint technologies

3) To design facility considering with economic and cost-saving (Smart Facility)

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4) To design facility with safety and comfortableness to protect from experiment accidents)

To design facility to be opened to society and having easy accessibility

(3) Facility Planning

For ITB and IPB 3-storey building with 25 Rental Laboratories consisting of 1)11 rooms @ 52

sq. m rental space for laboratory, 2) 8 rooms @ 104 sq. m rental space for laboratory and 3) 6

rooms @ 52 sq. m rental space for office.

Each floor area is 1,000 m2

and total area is 3,000 m2 for a building prototype.

Because NARC-BPPT is a coordinator for the counterparts, the Integrated Support Center will

be added to NARC-BPPT building with floor area of 1,000 m2.

(4) Research Center/Park in General

NARC will lease the land of Research Center to companies with larger research equipment and

production. The facility will be built by the company itself. The facilities that NARC provides

are the ground pavement, electricity and water with basic infrastructure. Research center area is

4.7 ha based on the examples of existing models in other Asian countries.

(5) Operating Structure

Operation of Incubation Center, which constitutes the cluster as the main facility, is to have the

organization system shown below. Directors will be placed for each of 3 main centers, overall of

facilities will be managed by a Vice-president. Integrated Support Center cares tenants who are

the residents in each facility in a cross-sectoral manner. The center will coordinate joint research

and business matching and advise regarding law and intellectual property to the tenants. In case

of establishing SPC, a management department will be established in Integrated Support Center.

(6) Tenants Support

Incubation manager has the role to lead person who aims entrepreneurship and independence or

young company to the achievement of business, advising against various consultation such as

knowhow of entrepreneurship and management. At the beginning of business, the manager

SPC President

Integrated Support Center

援センター

Director A

Director B

Director C

Vice-president IPB-NARC

ITB-NARC

BPPT-NARC

gra

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supports to make business plan of how to solve funding problem, provides information of

subsidies and loan, and introduces fund.

Incubation manager is a professional to support the person who aims entrepreneurship and

establishment, from the beginning of plan to entrepreneurship or establishing. Main role of

incubation manager is as follows:

1)Industry-university cooperation

2)New business development

3)Strategy development of intellectual property

4)Market expansion (Business matching)

5)Funding support

6)Human resources support

IPB and ITB Incubation Center Building: Floor Plans Site Plan and Section

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BPPT Incubation Center and Integrated Support Center Building Floor Plans and Section

Project Cost Estimation

(1)Initial Costs Estimation (Rp. Million)

BPPT-NARC IPB-NARC ITB-NARC Total

1.Civil Work(Research Center)

Civil Work Total 31,101 34,102 33,764 98,968

2.Building Work (including parking area)

Building Work Total 70,599 55,048 55,048 180,696

3.Research Equipment

Equipment Total 12,667 17,594 14,779 45,040

Civil/Building/Equipment Total 114,367 106,744 103,591 324,704

4.Transaction Advisory Cost

Total 15,000 15,000

Grand Total 339,704

(2)General and Administrative Expense (Rp. Million)

Cost Item Cost

Maintenance and Replacement Cost 1,992

Utility Cost ( Electricity, Water) 1,298

Labor Cost for NARC (I.S. center, Incubation center) 3,451

Outsourcing Cost (security, cleaning, maintenance) 1,858

Sub total 8,599

Overhead Cost (5% of above items) 430

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total 9,029

(3)Income of Laboratory Rentable Fee (Incubation Center)

BPPT-NARC IPB-NARC ITB-NARC

Rentable area (m2) 1,612 1,612 1,612

Rentable rate (US$/ m2) 18 18 18

Sub Total (US$) 29,016 29,016 29,016

(4)Income of Land Leasing Fee (Research Center)

BPPT-NARC IPB-NARC ITB-NARC

Land leasing area (ha) 3.87 3.87 3.87

Leasing rate (US$/ m2) 1.5 1.5 1.5

Sub Total (US$) 58,050 58,050 58,050

Total (US$) US$174,150

Project Structure

Among four project scheme alternatives envisaged for the project implementation, the PPP

Scheme (Alternative 1) is considered best suitable because it follows the PPP framework

(PR67/2005) specifically prescribed for Public-Private Partnership projects just like NARC

where the private sector is responsible to the whole project scope including construction and

operation but needs significant government support to enhance the financial viability. The

scheme ensures the single process that covers preparation, procurement and government support

such as VGF; therefore it is attractive to private investors. Only downside is that the current PPP

regulation is not applicable to the R&D facilities and requires an amendment which is currently

under formal consideration of the government upon BPPT‘s request.

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Alternatively, the Hybrid Scheme, which involves in-kind government contribution by dividing

project scope, is considered the second best alternative. The merit of using the scheme is that it is

applicable under the current regulatory setting (GR06/2006). Since the procurement is

two-folded, contractual setting is more complicated and running risk of delay in implementation.

Unlike VGF managed by MOF, the ordinary national budget is used for the public construction

portion, so that it may be affected by the budget constraints of BPPT (and/or IPB/ITB).

Alternative 1: Public Private Partnership (PPP) Scheme

Private

SPC

PPP

Agreement

GCA(BPPT)

MoF

Operation

Company

Construction

Fee

Construction

Company

Operation Fee

Financial

Institution

Loan

VGF

Private

Investors

Equity

State

Univ.

Profit Sharing

Right to use

the land

Land & Profit

sharing agreement

Profit

sharing

Right to

use the land

Cooperation agreement

Tenants(Incubation/

Support Center)

-Rent lab/office spaces-Use common instruments

Tenants(Research Center)

-Rent land lots-Construct and use own research facilities

Incubation/Support Center

Research Center

Rent Fee Rent Fee

Finance

Build Private

PrivateOperate

Private Public

PrivateDesign

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Pros and cons of the both scheme alternatives are summarized below.

Private

BOT/BTO

Agreement

GCAConstruction

Company

MoF

APBN

Private

Contribution

Operation

Company

Construction Fee

Construction Fee Construction

Company

Operation Fee

Financial

InstitutionLoan

Alternative 2: Hybrid Scheme

Incubation/Support Center

Research Center

Tenants(Incubation/

Support Center)

-Rent lab/office spaces-Use common instruments

Rent Fee Rent Fee

O&M

Tenants(Research Center)

-Rent land lots-Construct and use own research facilities

Public

Finance

Build Private

PrivateOperate

Public Private

Support /Incubation Center

Research Center

Design Private

Pros

Cons

PPP Scheme Hybrid Scheme

Framework specifically tailored for Public-Private Partnership

Single framework covers preparation,procurement, and government support (VGFand guarantee) process of the project

Attractive to private investors

Uncertainty in PPP regulation amendment byGOI

Applicable under the current regulatorysetting

Complexity in process and contractual settings forthe public investment and the private DFBOT

APBN budget / ODA funding constraints

Asset ownership issue from construction by APBN

Longer time for operation (with ODA loan case)

Private operator who’s free of facility investment(for Support/Incubation Center) may tend to over-spec design which may lead to construction costincrease borne by the Public.

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Financial and Economic Analysis

Financial Analysis

In the financial analysis, the project‘s financial viability and sustainability was evaluated based

on the estimated capital investment and O&M cost, predicted project revenue and other

assumptions. Cash flow analysis has been conducted under both PPP scheme and Hybrid scheme

proposed in the ―Chapter 8 Project Structure‖. The detail of the prediction of revenue and

expenditure is explained in the main report.

Based on the revenue and expenditure of the project for 20 years of project period, the cost is

basically larger than the revenue.

Under PPP scheme, the difference between the revenue amount and cost will be subsidized by

(1)VGF (Viability Gap Fund) so that the SPC can make a reasonable profit.

Under Hybrid scheme, the public side procures the building of the integrated support center and

incubation center, and because of that financial support, the SPC can make higher profit in the

business. Therefore, the excess profit will be returned back to counterparts during an O&M

phase by means of (2)Private Contribution. The fee amount is determined by mutual agreement

in the contract.

The 70% of initial cost is assumed to be procured by PSIF loan of JICA, and the rest of 30% is

procured by the equity of SPC. For the financial analysis, the expected cost of equity is assumed

to be 15% based on the answers from possible investors.

Result of Financial Analysis

(1) Result of Financial Analysis under PPP Scheme

Rent Fee of Research

Center

Repayment of Capital

Investment Cost

Rent Fee of Incubation

Center

O&M Cost

TAX payment

Government Support

(VGF)

Revenue Cost

Public : IS center +Incubation Center

(55%)

Rent Fee of Research

Center

Private: ResearchCenter + Research Equipment (45%)

Rent Fee of Incubation

Center

O&M Cost

TAX payment

Private Contribution

Revenue Cost

Basic Concept

of VGF Calculation

Basic Concept of

Private Contribution

(1)

(2)

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Under the condition of retaining the Equity IRR of SPC at 15.0%, the necessary VGF amount

becomes 42% of total CAPEX. The VGF amount is less than 50% of total investment cost as

regulated by the Presidential Regulation. The necessary VGF amount under the said

assumptions satisfies the regulation rule.

The DSCR value starts at 1.10 in 5th year, and gradually increases as the project proceeds up to

8.61 in the 20th year.

The real subsidy amount, which is calculated by subtracting the total tax payment from the initial

capital cost by GOI (VGF amount), becomes Rp.72,879 million at present value. The discounted

rate is set at 8.4%/year based on the 20 years national bond rate of Indonesia in 2013.

(2) Result of Financial Analysis under Hybrid Scheme

Under the condition of retaining the Equity IRR of SPC at 15.0%, the payment of land lease fee

from SPC to the public becomes Rp.1,345 million. The Private Contribution is a fixed rate with

adjustment with corporation to the CPI rate, each year.

The DSCR value starts at 1.03 in 5th year, and increases up to 10.31 in the 20th year.

The real subsidy amount becomes Rp.83,545 million at present value. Compared with the PPP

scheme, the real subsidy amount under Hybrid scheme is Rp.10,643 million higher. The

difference mainly came from the delay of the operation for half year.

Economic Analysis

Research and development cluster area is typically located with associated manufacturing

clusters. Development of NARC is expected to induce manufacturing areas development (such

as industrial park). In this analysis, three industrial parks having land area of 10 ha each are

assumed to be developed near the three planned NARC sites.

Economic analysis of NARC project was made incorporating costs and benefits of

above-mentioned industrial parks. The discount rate to be used is the 12%, which is the

commonly used value for economic analysis in the country.

(1) Direct Economic Benefit

Manufacturing industries located inside the associated industrial parks purchase intermediate

goods and services outside the industrial parks, processes them using their own equipment and

labor, and then sell their products outside. Value of gross output can be divided into ―added

value‖ and ―intermediate consumption (input cost).‖ Of which, added value refers to the

additional value created at a particular stage of production. Value added can be divided into

operating surplus, payment of taxes, and worker‘s compensation (wage and salary). These

value added resulting from the economic activities of locators in the associated industrial parks

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is considered as direct economic benefit of the project.

Based on the past record of each industrial sector, the economic benefits generated within the

associated industrial parks were calculated to be Rp. 529 billion per annum (BPPT-NARC:

Rp.131 billion, IPB-NARC: Rp.121 billion and ITB-NARC: Rp. 277 billion).

(2) Induced (In-direct) Economic Benefit

Inter-industrial linkages may influence industrial structure and economic development in a

country. Production activities in one sector may have effects that directly and indirectly induce

those in other sectors. A unit increase in final demand for an industry in the associated industrial

parks with strong inter-industrial linkages can induce a larger increase in production and thus

promote economic development even outside the associated industrial parks.

Such indirect economic effect (value added induced outside the associated industrial parks) was

estimated to be Rp. 873 billion based on the above-mentioned direct economic benefit and

inverse matrix calculated using Input-Output Table with 66 economic sectors of Indonesia 2008.

Results of Economic Analysis

(1) Calculation of Economic Internal Rate of Return

The calculated EIRR was 24.7%, which exceeds the economic opportunity cost of 12%. In

addition, ENPV (Economic Net Present Value) discounted at rate of 12.0% was worked out at

Rp. 1,818 billion.

These calculation results proved that the NARC and associated industrial parks development

projects are feasible from the economic point of view.

(2) Sensitivity Analysis

Economic benefit-cost analysis is based on forecasts of quantifiable variables such as capital

cost, O&M cost and benefit scenario. The values of these variables are influenced by a great

number of factors, and the actual values may differ considerably from the forecasted values.

It is therefore useful to consider the effects of likely changes in the key variables on the viability

of a project. Sensitivity analysis was made using following adverse scenarios; 1) increase in

capital cost +20%, 2) decrease in economic benefit -20%, and 3) worst case, a) + b).

EIRR of all alternative cases exceed the 12%, and the economic viability of the NARC project is

considered robust under the various adverse scenarios.

Risk Analysis and Mitigation Measures

The risk analysis was conducted in the following method.

(1) Risk matrix is made for both PPP scheme and Hybrid Scheme to recognize the risks under

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different contract condition.

(2) The risk mitigation (reduction, transfer, avoidance) method is considered for identified major

risks.

(3) Financial impact of several risks is estimated by anticipating the change in the revenue and

cost. The result is described in the sensitivity analysis of financial analysis in ―Chapter 9.3.6

Sensitivity Analysis.‖

In this study, two risk matrixes are made assuming the NARC Project is implemented under PPP

scheme or Hybrid scheme, as the characteristics of risks and the proper entity which owns risk is

different in each case.

The risks with lower probability and lower financial impact could be owned by the SPC without

any mitigation measures. The characteristics and its mitigation methods of important risks in the

10 risk categories; 1) Site Risk, 2) Design, Construction and Commissioning Risks, 3) Sponsor

Risks, 4) Financial Risks, 5) Operation Risks, 6) Revenue Risks, 7) Interface Risks, 8) Political

Risks, 9) Force Majeure Risks, 10) Asset Ownership Risks, which have the middle or high

impact and/or probability.

The evaluated alternative cases in the sensitivity analysis and the related major risks, which have

been identified in the Risk Matrix are shown in the following table.

Case Condition Related Risk identified in the Risk Matrix

Case1:

Reduction of Occupation Rate for I.S. center, incubation center and Research center. (-10%)

- Decrease in the demand volume on Incubation Center - Decrease in the demand volume on Research Center - Development of other competitive public facility in the same region

Case2:

Cost increase (Capital cost and O&M cost, + 10%)

- Increase in construction cost due to designing issues - Design brief risk - Construction cost increase - O&M cost overrun risk - Increase in energy costs - Increase in maintenance and replacement cost of research equipment

Case3:

Delay of starting operation (1 year, with 20 years of project period)

- Delay and cost increase of Land Acquisition - Delay in completing construction works - Delay in achieving planning approval

Case4:

Decrease in IDR value by exchange rate change (-20%)

- Foreign exchange rate risk - Economic Downturn in Indonesia

Regarding the Case 1 condition, the financial loss by decrease in occupation rate of 10% makes

the worst financial loss on the cash flow. Therefore, the control of service level and securing the

incentive for tenants is considered as the key factor to secure the profitability of the business.

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For the Case 2, risk of cost increase (+10% of CAPEX and OPEX) could be transferred or shared

with the construction company and outsourcing company with careful contract designing.

For Case 3, the delay of operation start (1 year) makes the second highest impact, and the

financial condition is especially worsened in the early period of the project. The control of

construction work to start the work, and arrangement of tenants for early operation start-up is

what the SPC needs to focus on at the beginning stage of the Project.

The impact of Indonesian Rupiah devaluation risk (Case 4) is slightly smaller than the other

cases. The SPC should decide if they take risk or mitigate applying financial instruments or

linking rental fee of some tenants to the value in foreign currency.

Contracts Necessary for Project and Major Contents of Contracts

PPP Project

Contractual Framework of PPP Project

Prior to conducting procurement process, BPPT, IPB and ITB shall make Cooperation

Agreement. Since only BPPT can be GCA, those three parties need to have agreement for

scope of work, risk sharing and procurement, etc. The most important contract for the project

is PPP contract between BPPT (GCA) and Private company (SPC). This contract would

specify the right and obligation of GCA and SPC during the project period.

Additional contract, Land and Profit Sharing Agreement, is required for this project. Since IPB

and ITB cannot be a part of PPP Contract, those two universities would not have direct

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contractual relation with the Private without the Land and Profit Sharing Agreement. This

agreement basically prescribes that the universities would provide land to the project and

would be shared the profit from the project.

Hybrid Project

In case of Hybrid Scheme, the different contractual arrangement is required. Since the

construction of Incubation and Support Center shall be done by Public and that of Research

Center shall be done by the Private, at least two contracts are required; one is EPC contract and

another is BOT contract. EPC contract shall be based on Presidential Regulation No.54 Year

2010 on Government Procurement of Goods/Services (herein after ―PR54/2006).

1) Single GCA (BPPT)

In case of BPPT as single GCA, BPPT, IPB and ITB shall make Cooperation Agreement.

Since only BPPT can be GCA, those three parties need to have agreement for scope of

work, risk sharing and procurement among three parties for both EPC and BOT contract.

Contractual Framework of Hybrid Project (BPPT as Single GCA)

2) Joint GCA (BPPT, IPB, ITB)

When BPPT, IPB and ITB are joint GCA, Cooperation Agreement shall be required to

cooperate toward joint procurement. The BOT contract and EPC contract shall be made

between GCA (BPPT, IPB and ITB) and the Private.

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Contractual Framework of Hybrid Project (BPPT, IPB and ITB as GCA)

Environmental Impact Survey

Preliminary Examination of Possible Environmental and Social Impacts

(1) Possible Impacts on Medicine Manufacture Sector

By research activity on medicine manufacture sector, various types of chemicals will be used.

For producing of new vaccines and antibiotics, pathogenic bacteria will be handled. These

materials for experiment may increase risks on health to surrounding residents if appropriate

measure is not adapted. The NARC should develop regulations to handle these materials on

measure to control transportation, storage and usage of these materials should be established.

The introduction of simple Pollutant Release and Transfer Register (PRTR) system is

recommended to manage the materials for experiment with information disclosure to the

concerned stakeholders. Waste from research center should be also treated and disposed under

proper way by each tenant to avoid environmental pollution by generated solid waste. In case

that generated waste is categorized as B3 waste which should be handled by specific way

under Indonesian regulation, the SPC should instruct and manage the way of solid waste

disposal by tenant. Environmental pollution by wastewater may occur if wastewater is treated

in an unsuitable way. Regarding The NARC is expected to have centralized wastewater

treatment system to treat organic pollutant, but treatment of specific materials should be

conducted by each tenant to avoid impact to surrounding environment.

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(2) Possible Impacts on Agriculture and Food Production Sector

One of the important matters to be examined for research activity on agricultural and food

sector is gene recombination experiment. If such experiment is implemented, the products

should be controlled carefully to avoid disordered spreading of generated gene resources. In

agricultural and food processing sector, various chemicals will be used, and insects carrying

disease germs may be handled. Therefore, proper management of these materials should be

planned and implemented same as medicine manufacturing sector. In this sector, some research

activity may be implemented under outdoor condition. IPB can use their deep experiences on

this matter to avoid environmental pollution such as soil erosion, water pollution and impacts

on biodiversity of surrounding area due to experimental activity.

(3) Possible Impacts on Bio Industrial Sector

The scale of the impact is not large, but air pollution due to combustion test of produced fuel

should be controlled. Generated waste by producing of biofuel such as residue of raw materials

should be treated, cooperating with local solid water management system after checking

hazardousness of the waste to avoid environmental pollution by solid waste. Wastewater from

the research facilities will include oil substances. Therefore, tenant or NARC should have

proper treatment process of wastewater such as simple oil separator. It is considered that the

risk is not so serious, but generation of odor in the process of generating biofuel may be

affected to surrounding area, so the impact is recommended to be examined.

Required Actions on Environmental Impacts in Further Step

(1) Conducting of EIA under Indonesian Regulation

In the Environmental Ministry Regulation No. 05/2012, type and size of the project to be

implemented EIA is designated. Based on the regulation, development of NARC is categorized

as a project for construction of building. For this type of project, if the project alters equal or

more than 5 ha of land, or constructing of building, of which total floor space is equal or more

than 10,000 m2, such project should conduct EIA study. Therefore, for development of NARC,

EIA including evaluation of the following impacts should be conducted, and approval to

commence the project should be obtained.

Type of Project Scale Items to be Examined

Construction of buildings

- Area of land, or

- Building

> 5 ha

>10.000 m2

a. Land acquisition

b. Carrying capacity of the land

c. Levels of daily water needs

d. Waste generated

e. Effects of development on the surrounding environment

(vibration, noise, air pollution, etc.)

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f. The number and type of trees that may be missing.

g. Social conflicts due to land acquisition

h. Structure of buildings and basement causing problems and

disorders caused stakes to aquifer water source nearby

i. Traffic condition

j. Parking needs of visitors.

k. Inundation / flooding issue

Note: Above criteria is extract of the regulation.

(2) Environmental Consideration by JICA Guidelines for Environmental and Social

Considerations

In case that NARC development needs assistance by Japanese fund, the following

environmental and social consideration should be conducted based on the JICA Guidelines for

Environmental and Social Considerations has been applied since April 2010.

Projects must comply with the laws, ordinances, and standards related to

environmental and social considerations established by the governments that

have jurisdiction over project sites (including both national and local

governments).

Appropriate follow-up plans and systems, such as monitoring plans and

environmental management plans, must be prepared.

Projects must be adequately coordinated so that they are accepted in a

manner that is socially appropriate to the country and locality in which they

are planned.

Hereafter, to satisfy the above requirements, environmental management plan and

environmental monitoring plan should be developed. The contents to be included in the

environmental management plan are shown in the following tables.

Contents to be Included in Environmental Management Plan

(pre-construction phase and construction phase)

Item Contents Location Remark

Involuntary

resettlement

- Survey plan on income of affected farming

households by agricultural activity

- Consultation plan on alternative measures for

livelihood restoration

- Examination on alternative measures for income

restoration

Construction

site and

relevant area

BPPT-NARC

only

Impact on

local economy

- Construction work schedule for mitigating traffic

congestion

Construction

site and

relevant area

-

Public health - Construction workers‘ public health management

plan for reducing risk on infectious disease

Construction

site -

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Item Contents Location Remark

Soil erosion - Surplus soil disposal plan Construction

site -

Ecological

system

- Construction work facilities allocate plan for

avoiding cut of wood land by temporary facilities

Construction

site -

Air pollution - Air pollution control plan with water sprinkle for

prevention of scattering of dust

- Construction vehicle maintenance plan for checking

exhaust apparatus condition

Construction

site -

Water

pollution

- Countermeasure on turbid water discharged by

construction work such as construction of settling

pond

Construction

site -

Solid waste - Measure on disposal of constriction waste and

municipal solid waste from lodging house

- Hazardous waste disposal plan by contracting with

enterprises specialized in hazardous waste

management

Construction

site

-

Noise and

vibration

- Examination of countermeasures for reducing noise

level such as setting of noise barrier

- Examination of construction working time

Construction

site -

Accident - Planning of safety measures and accident

prevention plan

Construction

site and

relevant area

-

Contents to be Included in Environmental Management Plan

(operation phase)

Item Contents Location Remark

Public health - Hazardous waste management plan following

―Government regulation of the Republic Indonesia

No.74/2001 on Hazardous and Toxic Substance

Management‖

NARC site

-

Ecological

system

- Maintenance plan of greenery area in NARC site NARC site -

Air pollution - Obligation for tenants of NARC on submission of air

pollution control measures

- Air pollution control measure on combustion test

using bio fuel

NARC site

ITB-NARC only

Water

pollution

- Obligation for tenants of NARC on submission of

water pollution control measures

- Construction and operation guidelines for tenants of

NARC to construct wastewater pre-treatment system

considering characteristics of wastewater discharged

from each tenant

- Construction and operation plan of wastewater

treatment system of NARC

NARC site

-

Solid waste - Obligation for tenants of NARC on submission of

solid waste management plan

- Hazardous waste management plan following

―Government regulation of the Republic Indonesia

No.74/2001 on Hazardous and Toxic Substance

Management‖

- Guidelines for sub-contracting with special enterprises

on hazardous solid waste disposal

- Municipal solid waste disposal plan by NARC

NARC site

and relevant

area

-

Noise and

vibration

- Obligation for tenants of NARC on noise and vibration

control plan

NARC site -

Accident - Obligation for tenants of NARC on accident NARC site -

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Item Contents Location Remark

prevention measures

- Obligation for tenants of NARC on emergency

response plan in accidental cases

- Chemicals management plan following ―Ministry of

Manpower Decree No. 187/MEN/1999 on chemicals

control at work place‖ and ―Regulation of the Minister

of Trade No. 04/M-DAG/PER/2/2006 on Distribution

and Monitoring of Hazardous Materials‖

Implementation Procedure and Schedule

The implementation procedure of the PPP Scheme and the Hybrid Scheme is summarized in the

table below. The critical path that the PPP Scheme depends on in its implementation process is

the amendment to the PPP Regulation, whereas that of the Hybrid Scheme is obtaining access to

the national budget appropriation for the public construction. Procurement of the private partner

will take similar flow for both schemes. However, the bid evaluation of Hybrid Scheme applies

Scoring System which takes into account the technical evaluation to determine the winning

bidder; whereas VGF amount is only bidding parameter in the PPP Scheme procurement.

PPP Scheme Hybrid Scheme

1 Regulatory Basis PPP Regulation (PR67/2005), etc

(Amendment required)

State and Regional Asset Management

Regulation (GR06/2006)

Government Procurement Regulation

(PR54/2010), etc.

2 Budgetary

Appropriation

In-principle approval of VGF by MOF APBN budget for the public construction

(Incubation and Support Centers)

3 Procurement for Private Partner

Special support for

proponent bidder

None

(The project is considered solicited)

None

(Regulation does not provide such treatment)

Prequalification Yes Yes

Bidding Method Two-envelope Method Two-envelope Method

Bid Evaluation Evaluation for PPP contract tender

- Technical: Pass or Fail

- Winning bidder: Only financial

bid is evaluated

Scoring System

- Technical: Pass or Fail

- Winning bidder: Comprehensive

evaluation of technical and financial

proposals (financial: 70-90%)

Bidding Parameter Required VGF amount

(Lowest bid wins)

Annual private contribution amount

(Highest bid takes highest financial scoring)

4 Other

Procurement

None

(Private partner is responsible to

construction works)

Procurement for the public construction

- Supported by the private partner

- Tender documents, PQ and Public tender

5 Operation and

Management

With appropriate contract conditions, the both scheme can ensure the same operation and

management setup. (The Private is responsible to the whole operation and the Public does

monitoring.)

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Assuming a favorable scenario in which the amendment to PPP Regulation is legalized in June

2014, the operation of NARC will commence in the first quarter of 2018. In the Hybrid Scheme,

it should be noted that the procurement process takes place two times for the BOT contract and

the public construction separately, which take longer period than in the PPP Scheme.

Ex-ante Evaluation of Project Effects

Regarding to the evaluation of the Project impact, the counterparts and the JICA Study Team are

planning to adopt the following Evaluation Indicators. The Ex-Post Evaluation could be

conducted at 4th year of the Project, which is after 2 years of the construction completion. The

draft project effectiveness indicators are planned as follows;

Effect Indicators Target

PPP Scheme Hybrid Scheme

1. Occupancy rate of the Integrated Support Center, Incubation Center and Research Center

I.S. Center and Incubation Center

70%, 4th year

(80%, 8th year)

60%, 4th year

(80%, 8th year)

Research Center 40%, 4

th year

(100%, 8th year)

30%, 4th year

(90%, 8th year)

2. Increase in employment in Research Center

BPPT/ITB: 47.5 people/ha IPB: 156.3 people/ha

399 people, 4th year

(998 people, 8th year)

299 people, 4th year

(898 people, 8th year)

3. FIRR (Financial Internal Rate of Return), NPV (Net Present Value)

Cost: Project cost Revenue: Project revenue

FIRR: 14.4% NPV: Rp. 83,619

million

FIRR: 15.1% NPV: Rp. 85,628

million

4. EIRR (Economic Internal Rate of Return), ENPV (Net Present Value)

Cost: Economic project cost Benefit: Increase in surrounding manufacturing area

EIRR: 24.7% ENPV: Rp. 1,834

billion -

The following indicators are the draft operation indicators of the Project, which should be

monitored every year to evaluate the service level provided by SPC. The target number of each

indicator is to be described in the Output Based contract made between SPC and counterparts.

Operation Indicators Target

Number of cooperative researches conducted between counterparts and tenants in NARC

To be fixed in the contract

Number of innovation technologies which has been consulted by the specialist of intellectual property in Integrated Support Center

Number of Business Matching Events by NARC

Usage frequency of Research Equipments

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List of Actions to be Taken by Indonesian Side

Actions to be taken by Indonesian side with target completion date are summarized as follows:

Issues/Topic Actions to be Taken Responsible

Party

Target

Completion

Date

Industrial

Promotion

Policies

and

Mechanism

Relationship

Building Between

Industry and

University

Hold ―Intellectual

Exchanges‖ on key topics

to identify market needs of

industry and R&D

capabilities

Develop ―Site Miners‖ at

each NARC campus to

help in matchmaking with

industry requests for

technical assistance and

applied research

BPPT, IPB, ITB By mid-2015

Applied Research

&Commercialization

Support

Establish a NARC

proof-of-concept fund to

advance

university-business

research discoveries

Offer a matching grant

program for

industry/university applied

research projects

BPPT, IPB, ITB

RISTEK

EKUIN

BAPPENAS

Min. of

Education

By opening

of NARC

R&D Incentives Research and Development

Tax Credit

Patent Box –Lower

corporate tax rate from sale

of Indonesia patented

products

Tax Credits for Hiring

Scientists and Engineers

EKUIN

BAPPENAS

By opening

of NARC

Industrial

Promotion

Actions

Related to

Target

Markets

Pharmaceutical

Industry Platform:

Herbal Medicines

Increased analytical lab

capacity for identifying

and characterizing

bio-active ingredients

More rigorous efficacy

studies involving

high-throughput

laboratory-based in vitro

studies as well as

human-based clinical

studies

Longer term --Increased

synthetic chemistry

capabilities to advance

BPPT After

opening of

NARC

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Issues/Topic Actions to be Taken Responsible

Party

Target

Completion

Date

natural product drug

discovery and development

Pharmaceutical

Industry Platform:

Bio-pharmaceuticals

for Diagnostics,

Vaccines and

Antibiotics

Address need for increased

capacity for bio-scale-up

facilities and expertise

Offer incentives to further

partnerships with foreign

biopharmaceutical

companies at NARC sites

–including relaxation of

foreign ownership limits

BPPT

BAPPENAS

EKUIN

After

opening of

NARC

Pharmaceutical

Industry Platform:

Pharmaceutical Raw

Materials

Increase government R&D

funding to advance

competitive advantages for

Indonesia through

development of novel

active pharmaceutical

ingredients, innovative

formulation technologies

or novel drug delivery

methods

EKUIN

RISTEK

Min. of

Education

By opening

of NARC

Agriculture and

Food Platform:

Agricultural

Improvement &

Diversification

Improve facilities to

advance plant breeding and

seed development for

improved and diversified

crops

Support growing tropical

fruits markets for export

growth –improve

post-harvest technology,

food safety, pest and

disease control

IPB After

opening of

NARC

Agriculture and

Food Platform:

Value Added Food

Products

Need for specialized

laboratory equipment as

well as scale-up processing

technologies to

characterize, separate,

purify and process

bio-active chemicals in

crops and developing new

health-promoting food

products

IPB By opening

of NARC

Industrial Bio

products Platform:

Palm Oil Bio

Products

Pilot broader processing of

palm oil within Indonesia

Increase yields through

improved agronomy,

ITB After

opening of

NARC

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Issues/Topic Actions to be Taken Responsible

Party

Target

Completion

Date

fertilizer usage and

improved plant varieties of

palm trees

Consider testing and

validation facilities

Actions

Related to

Industrial

Promotion at

Each NARC

Site

Pharmaceutical

Industry Platform

Development of pilot Good

Laboratory and Good

Manufacturing Practices

scale-up infrastructure for

the production of human

biologic products in

volumes required for

conducting Phase I and

Phase II clinical trials with

attraction of Contract

Research Organizations for

conducting clinical trials

BPPT After

opening of

NARC

Agricultural and

Food Industry

Platform

Advanced plant sciences

and crop improvement

research and development

center with modern

analytical lab resources,

modern environmentally

controlled growth

chambers and fields

IPB By opening

of NARC

Industrial Bio

product Platform

Development of an

integrated bio refinery

operation working in both

biochemical and

thermochemical

conversion technologies

ITB After

opening of

NARC

Legal (PPP Regulation) Amendment of PPP

regulation (PR67/2005)

(To include R&D facility

as a targeted facility)

BPPENAS,

EKUIN, MOF,

other concerned

Ministries

Jun, 2014

Incentive policy Expansion of Incentive

Polity for R&D activity

MOF, RISTEK By Opening

of NARC

(2018)

Project Scheme Determination of Project

Scheme (Weather the

scheme based on PPP

regulation or Hybrid)

BPPT, IPB, ITB Immediately

Budgeting Budgeting for VGF (under

PPP regulation) or

Construction of incubation

BPPT, IPB, ITB

(MOF)

PPP(VGF):

by the early

2016

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Issues/Topic Actions to be Taken Responsible

Party

Target

Completion

Date

center and support center

(hybrid)

Budgeting for the cost for

procurement

Hybrid(APB

N): by the

end of 2016

Organizational Setup Organizational setup (e.g.

Government Contracting

Agency as BPPT, IPB, and

ITB?, three party

agreement, project team

formation)

BPPT, IPB, ITB Immediately

Procurement of Consultant (PPP) Selection of

transaction advisor

BPPT, IPB, ITB By beginning

of 2015

Demand Creation Prepare detailed ―Action

Plan‖ to gather more

possible tenants for long-

term basis

BPPT, IPB, ITB, Immediately

Demand Creation Disseminate the

information of NARC to

enterprises of Indonesian

and other countries

-Press release and seminar

for NARC dissemination

-Maximum utilization of

domestic and international

bio-industry conferences

and exhibitions

-Continuing individual

interviews, company by

company basis

BPPT, IPB, ITB, Immediately

Demand Creation Clarify attitude and policy

of Indonesian

governmental support

including incentive

mechanism on bio-industry

BPPT, IPB, ITB, Immediately

Demand Creation Create new matching

system to collect partners

effectively

- Opportunity to

co-research and

co-development with

national institutes,

universities and companies

BPPT, IPB, ITB, Immediately

Expansion of Research Center Prepare expansion of

research center site when

the demand increases

BPPT, IPB, ITB

and Private

Follow the

increasing

demand from

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Issues/Topic Actions to be Taken Responsible

Party

Target

Completion

Date

2018

Determination of NARC site

location

Decide the site for NARC

Facility by coordinating

with concerned authorities

(BPPT and IPB with MOF,

ITB with Bukasi regency)

Agree with Ministry of

Finance on the land use for

NARC facility

MOF, RISTEK

BPPT, IPB, ITB

Bekasi regency

Immediately

Plan and Budget for new

approach road

Plan the construction of

approach road about

budget and time schedule

BPPT, IPB, ITB

and concerned

authorities

By August

2014

Capacity and Connection Confirm the capacity and

present connecting points

for infrastructure

(electricity, water, sewage,

communication and so on)

BPPT, IPB, ITB

and concerned

authorities

By the end of

2014

Administration and Proceeding Coordinate laws and

proceedings with related

government, regency,

aviation and etc.

BPPT, IPB, ITB

and concerned

authorities

By June,

2016

(starting

from 2015)

Risk Management Take countermeasure on

any risk of construction

with monitoring

BPPT, IPB, ITB

and Private

During

construction

period

Coordination of Stakeholders Complete the resettlement

of peoples using the land

proposed for project site

for farming, stock farming

and etc.

Coordinate among

stakeholders in the

proposed sites for NARC

facility

(PPP)RISTEK

BPPT, IPB, ITB

(Hybrid)SPC

By the end of

2014

Environment Impact

Assessment (EIA)

Conduct EIA based on

Indonesian EIA regulation

(Each NARC development

plan alters equal or more

than 5 ha)

SPC By the

commencem

ent of NARC

Developmen

t

Compliance on

Environmental Consideration

by JICA Guidelines for

Environmental and Social

Considerations

Implement Environmental

and Social Considerations

in line with JICA

Guidelines:

Comply with the laws,

SPC Before

requesting

Japanese

fund for

NARC

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Issues/Topic Actions to be Taken Responsible

Party

Target

Completion

Date

ordinances, and standards

related to environmental

and social considerations

established by the

governments that have

jurisdiction over project

sites (including both

national and local

governments).

Follow-up plans and

systems, such as

monitoring plans and

environmental

management plans, must

be prepared.

Coordinate the projects

so that they are accepted in

a manner that is socially

appropriate to the country

and locality in which they

are planned.

development

, if necessary

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Introduction: Present Situation, Problem Areas and Necessity of New

Academic Research Cluster

0.1 Background of NARC Project

Both governments of Indonesia and Japan agreed on ―Metropolitan Priority Area (MPA) Initiative‖

to promote further growth of Jakarta metropolitan area acting as a driving force for Indonesian

economy as a prospective area suitable for more attractive industrial investment, while the nation

has been achieving stable economic growth in recent years. Included in the projects under MPA

Initiative are not only improvements of hardware infrastructure such as transportation systems but

also preparation of research and development facilities aimed at furthering progress of

industrialization and fostering human resources. For preparation of facilities at universities and

research institutions, plans have been so far implemented for expansion and improvement of

research facilities at national universities (lending of funds to Bogor Agricultural University,

Bandon Institute of Technology, etc.), preparation of the center for conservation of biotic diversity

(grant of funds to Indonesia Science Academy: LIPI) and construction of the center for microbial

resources (technical corporation to LIPI). Although such preparation and improvement of

facilities at universities and research institutions have been displaying important functions in

bio-related fundamental researches; shortage is seen of the research and development bases

connecting results of such fundamental researches to industrial development; few of their bases

are effectively functioning enough for industrialization. Thus preparation of research and

development cores is needed and regarded as an urgent issue in order to promote industrialization

of research and development results through industry-university cooperation.

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Source: MP3EI

Figure 0.1.1 MP3EI Chart Explaining Relationships among Public, Academics and Markets

0.2 Position of Project in Development Policy for Industrial Sector in Indonesia

―Master Plan for Acceleration and Expansion of Economic Development (MP3EI)‖ , which is the

national development plan from 2011 to 2025, provides for the theme to invest the scheme

promoting innovation-oriented economic growth based on human resources through improving

productivity as a policy toward achievement of target value of US$15,000 for per capita GDP in

2025. The research and development cluster project (hereinafter called ―Project‖) is intended to

create research and development cores to promote industrialization of research and development

outputs. Project is also positioned as one of the five flagship projects among 45 projects covered

by MPA (MPA is positioned as one of the accelerators of MP3EI).

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Source: MP3EI

Figure 0.2.1 Increased Productivity to Competitive Excellence

The purpose of NARC is, as shown in Indonesian MP3EI, to promote ―creation of a cluster to

found the innovation-based economy by reinforcing cutting-edge technology.‖

MP3EI describes economy developments has been supported by mineral resources, then by

industrial, capital, and technology, then will be transformed to innovation and human capital

(Figure 0.0.3). Present Indonesian economy is booming with mainly assembly industries like

automobiles, but would lose its international industrial competitiveness by higher wages caused

by higher quality of life achieved. Innovation by industrializing and commercializing R&D

outputs will create new high-value-added industries and foster resources for competitive human

resources and job opportunities.

0.3 Outline of New Academic Research Cluster

Details of New Academic Research Cluster project are described in each chapter of this report

stressing importance of the project for Indonesia. Brief introduction of outline, especially of

overall concept, of the project, herewith has been prepared.

INNOVATION - BASED

ECONOMY

NARC as

Igniter

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Original concept of NARC starts with MP3EI:

NARC will ignite Indonesian movement to innovation-based economy as directed in MP3EI

By bridging R&D/academic sector and industrial sector with 3 functional elements

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Source: MP3EI, JICA Study Team

Figure 0.3.1 Introductory Chart of NARC Project

Phase-1 Creating System of Bio Cluster Phase-2 Enhancing Bio Industry

*R&D Firm

Existing

IndustryUniversity

Research Institute

BPPT

IPB

ITB

Sales

channelstoCustomer,

Consumer

*Supplier

(Instruments, Material,

Services)

*Bio Specialty Firm

(R&D, Manufacturing,

Marketing, Sales)

Joint Research

Products,

Services

En

tre

pre

ne

urs

hip Alliance, M&A,

Commissioned research

Patent saleTechnology Licensing

Organization

(TLO)

Products,

Services

Venture

Incubation

Industry-academia

collaboration

Attracting

Foreign Bio Firm

Foreign

Bio Firm

NARC Bio/Life Science Innovation Eco System

SPC

P - 1 P - 2

GOJ GOI

Investors

Production Factories

Academics

R&D Companies

Small Businesses

To the goal of creating an innovation eco system where stakeholder interact each other

Where academic, public, and private sector can support each other to share benefits

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Above chart explains about New Academic Research Cluster project (hereinafter called as

NARC) with its connection to MP3EI, its future goal, its function, and its stakeholder.

As outlined in this chart, NARC is to ignite new movement of Indonesia for moving toward the

next phase of economy; that is, innovation-based economy as designed in MP3EI.

Its goal is to create an ―Innovation Eco System,‖ where every stakeholder can link each other, rely

on each other, interact with each other, and flourish together by industrialization of outputs

through joint research and development activities by Indonesian and overseas academic sectors.

As the first NARC for JABODETABEK area, utilizing its potentiality of bio and life science

resource, NARC Bio/Life Science Innovation Eco System is intended as the goal of this project.

0.4 Function of Project

(1)Concept of the project

The research and development cluster is constructed to perform the function of bridging between

academic research institutions such as existing universities, etc. and the industrial circle.

Hardware facilities and software operation of this cluster are equipped with three functions

consisting of each stage from research results through industrialization thereof for the purpose of

―industrialization of research results‖ and its concept is shown in the chart below,

New Academic Research ClusterInitial

Relations

Future

Relations

Microbial

Resource

Center ※ Bio

Industries

Existing

Laboratories

Other

Industries

Business

Incubation

Centers

Research

Centers

Existing

Academic

Institutions

Integrated

Support

Center

※Project Supported by JICA

Bridging Academic and Industry Sectors

For High Value Innovation

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Source: JICA Study Team

Figure 0.4.1 Bridging Function of NARC

(2)Outline of the project

This cluster is composed of Integrated Support Center which acts as the core of bridging,

Incubation Center which promotes venture undertaking and joint research, and Research Center

which is the complex of research enterprises aiming at commercialization and industrialization.

Integrated Support Center is located only on the site of BPPT-NARC which becomes the core

execution organ. The size of facilities is planned as described in the following chapters.

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Table 0.4.1 Outline of the Facilities Included in the Project1

Facilities

Agency for the Assessment and Application of Technology (BPPT), located at Puspiptek Serpong Science and Technology Park

Bogor Agricultural University (IPB), located at Darmaga Campus

Bandung Institute of Technology (ITB), located in Bekasi

Integrated Support Center 1,092 ㎡ ― ―

Incubation Center (land) (building)

1.0ha 3,276㎡

1.0ha 3,276㎡

1.0ha 3,276㎡

Research Center 4.7ha 4.7ha 4.7ha

Note: Integrated support center will be located only at BPPT-NARC site.

Source: JICA Study Team

Source: JICA Study Team

Figure 0.4.2 Location of the Facilities in JABODETABEK

0.5 Overseas Research Activities of Japanese Companies and Position of Indonesia

In recent years, overseas research bases of Japanese companies in China and Korea decreased, in

comparison with former years, but increased in other Asian areas. China used to be the target of

1 The following three sites were selected and the detail of each institutions will be described in the following chapters:

-Agency for the Assessment and Application of Technology (Badan Pengkajian dan Penerapan Teknologi, BPPT)at Puspiptek

Serpong、Science and Technology Park (Pusat Penelitian Ilmu Pengetahuan dan Teknologi)

-Bogor Agriculture University (Institut Pertanian Bogor, IPB ) Darmaga Campus

-Bandung Institute of Technology(Institut Teknologi Bandung, ITB)at Bekasi

ITB-NARC

ITB-NARC

BPPT-NARC

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R&D bases as a huge market, but the target is now on Southeast Asian nations for faster

economic growth as the next target. The area continues to be the target of R&D bases of Japanese

companies. Indonesia, among them, is the biggest and is expected to be a major target of R&D

activities.

Source: Ministry of Economy, Trade and Industry, ―Research Trend in Industries,‖ July 2012

Figure 0.5.1 Location of Overseas Research Bases from Japan

Source: Ministry of Economy, Trade and Industry, ―Research Trend in Industries,‖ July 2012

Figure 0.5.2 Reasons of Overseas Japanese R&D Bases

Reasons of overseas research bases:

- R&D to reflect local market needs,

MEXT: Ministry of Education, Culture, Sports, Science and Technology, 2010

USA Europe China Korea India Other Asia Others

Research in 2007

Research in 2010

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- R&D cost reduction,

- Connection with local enterprises and academic entities,

- Competitive local human resources

Indonesia fits best among all the ASEAN nations with these reasons. As shown in the following

figure, the ratio of overseas R&D expenditure by various sectors shows 14% by pharmaceuticals

at the top, manufacturing 3.1%, chemical industry 1.4%, and transportation equipment 1.4%.

Investment on overseas research activities is very high in pharmaceuticals. A recent trend has

shown shift focus from chemical synthetic pharmaceuticals to bio pharmaceuticals. Such a trend

can positively affect the transfer of research functions to Indonesia.

Source: Ministry of Economy, Trade and Industry, ―Research Trend in Industries,‖ July 2012

Figure 0.5.3 Industry-wise Japanese R&D Investment

0.6 Necessity of NARC

As discussed above, establishment of new industrial cluster is necessary in order to promoting

the creation of cluster of innovation-based economy by reinforcing cutting-edge technology and

bridging the academic research institutions and industrial circles, and responding to the needs of

Japanese companies for their overseas R&D activities. Moreover, in order for such cluster to be

competitive considering the increasing competition among similar facilities in neighboring

countries, strategic investment by the Indonesian government to support the cluster is inevitable.

All Industry

Manufacturing

Chemical

Steel

General Machinery

Electric Machinery

Transport Equipment

Telecommunication

Pharmacy

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Such supports include 1) Financial support to the development of cluster such as Viability Gap

Funding in order to reduce the level of tenant fee so that the fee can be attractive compared to

other countries; and 2) various inventive mechanisms for companies such as tax exemption and

inventive on intellectual properties to promote the R&D activities of the companies.

As the last summary of this introductory chapter, the necessity of The New Academic Research

Cluster (NARC) from view points of 4 stakeholders (private and public sectors of both Indonesia

and Japan.) with SWOT matrix is described below.

Overall relationships of stakeholders with activities incurred by NARC are explained in the Chart

below:

Source: JICA Study Team

Figure 0.6.1 Stakeholder Roles

Existing issues for these 4 stakeholders can roughly be summarized as follows:

Stakeholder Roles

SPC: Facility Construction/ Initial Operation for 20years

Central Government

Big Enterprises

Small/Medium/Venture

Enterprises

Local Government

BPPT IPB ITB Others

StudentsResearchers

Integrated Support/ Incubation/Research Center

Technology Licensing, Matching, Research Events, Business Consulting

Incentives

R&D jobs

Entrepreneur

Fund, Policy

Operate

Tenants

Promotion

Talent

Job Training/Education

Supply ResourcesFund Raising

Licensing

Commercialization

Linking/Networking

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(1) Government of Indonesia

Strength :Powerful momentum toward developing economy and becoming one of top

leading countries

Weakness :Less chances of acquiring trials and investment for transferring into next

economic phase

Opportunity :Opportunity for change by using private and foreign investment and

knowledge for transition

Threat :Being kept behind with competing countries because of middle-income trap

and stagnating before reaching leading position by failing in transition out

of the present economy into next phase

(2) Private Sector of Indonesia

Strength :Passion and willingness to improve the society

Weakness :Not enough opportunity and environment to create new intellectual property

and use it for new industrialization

Opportunity :Being supported by governments and connected with overseas, opportunity

for realizing development by increasing competency of human resources and

by utilizing bio and other resources

Threat :Without support from in and out of country, no initiation of innovative R&D

and continuation of stagnated situation

(3) Government of Japan

Strength :Experience of transition management from developing stage into developed

country

Strong willingness to support international projects with various aids and

incentives

Weakness :Not many trials for new types (supports for transition of economy from

industry-oriented to innovation-oriented one) and levels of overseas aids and

cooperation

Opportunity :Chances of growing together with other countries while securing mutual

merits

Threat :With just exporting only goods or projects, losing international standpoints

and not expecting supports by other countries

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(4) Private sector of Japan

Strength : Knowledge and expertise of innovation and marketing

Willingness to international cooperation for mutual prosperity

Weakness :Difficulty in establishing long and reliable relationship for development of

social infrastructure with other countries

Opportunity :By partnering with public/private sector in other countries, opportunity for

merging with development of local social infrastructure for a long period of

time

Threat :Limitation of single and separate effort of each private company and

possibility of being lost in a transition of society

NARC can deal with the above-mentioned elements by reinforcing strength and opportunity, and

improving weakness and treat as follows:

Reinforcement of

Strength

:Ignition and acceleration of transition from the present

industry-oriented Indonesian economy into innovation-based

economy by industrializing R&D outputs through international

cooperation

Improvement of

Weakness

:By introducing this new type of international PPP aid scheme,

promoting involvement of multi-stakeholders and creating merits

for all stakeholders by creating innovation

Expansion of Opportunity :By utilizing past ODA properties of academics and R&D facilities,

opportunity for further success and reinforcement of ODA by this

social PPP infrastructure project for industrialization

Exclusion of Threat :By tracking on a long-term scenario of international cooperation,

establishing stable and reliable relationships and mechanism of

mutual prosperity

Why this can come true will be explained in the following chapters, which will prove this new

idea of NARC can definitely be a model of future international innovation aid mechanism.

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Chapter 1. Competitiveness Analysis for Indonesian Biocluster and

Survey for Industrialization Promotion

1.1 Overview

1.1.1 Background on New Academic Research Cluster Project on Bioresources

The New Academic Research Cluster (NARC) on Bioresources is part of activities under the

Metropolitan Priority Area (MPA) program, a cooperation agreement between the Governments

of Indonesia and Japan that was signed on December 10, 2011. The objective of the MPA is to

transform areas in Greater Jakarta (Jabodetabek) to be more attractive and more suitable for direct

investment and industrial development by accelerating infrastructure development.

The NARC is a science and research based infrastructure project scheme under the MPA. The

essence of NARC is an integrated physical environment where researchers and industries can

mutually conduct research, technology development, information exchange, mutual cooperation

and manufacturing of bioresource-based products to encourage industrialization and increase

national economic growth. The NARC program includes research and development,

revitalization of existing facilities, establishment of new commercial research and development

facilities, and human resource development.

The NARC on Bioresources will consist of three specific locations aligned with three individual

bioresource research institutions:

-Agency for the Assessment and Application of Technology (BPPT), located at Puspiptek

Serpong Science and Technology Park

-Bogor Agricultural University (IPB), located at Darmaga Campus

-Bandung Institute of Technology (ITB), located in Bekasi.

The success of NARC as a science and research-based economic development infrastructure

project depends upon an effective program for promoting industrialization. This requires

aligning research institution capacities and industry development potential to identify specific

targets of opportunity for industrialization within each of the three core clusters.

The key assessments needed to set out an effective program for industrialization promotion

include:

-Identifying high performance bioresources industry sectors that would benefit from research

and development

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-Identifying research institution assets and focus areas that can support research and

development leading to bioresource industrialization

-Advancing operation and management models for research and development

-Setting out paths for commercialization

1.1.2 Why University Research Park Development Matters for Bioresources Development

The importance of university research parks for advancing bioresources industry development is

inter-related with the growth of the globally integrated knowledge-based economy. In the past, a

nation‘s natural resources and proximity to markets were critical factors for business location. But

with the rising importance of knowledge workers and innovation, competitiveness for economic

growth depends on its ability to attract and facilitate industry, university and other research-driven

interactions. More and more man-made factors involving such factors as the presence of

university research and talent development drivers, as well as the depth and openness of a region‘s

research drivers to industry collaboration are critical factors for development. Also, while

natural resources remain an important asset, increasingly innovation and knowledge-assets play a

key role in driving value-added development incorporating these resources – thereby maximizing

development value for national and regional economies.

An interesting paradox is that the more globally integrated the world‘s economy has become, the

more local research and development (R&D) know-how, entrepreneurial culture, and workforce

skills matter for economic success. A 2009 Harvard Business Review article by Harvard

Professors Gary Pisano and Willy Shih refers to this phenomenon as creating

geographically-based ―industrial commons.‖ As they explain, ―Once an industrial commons has

taken root in a region, a powerful virtuous cycle feeds its growth. Experts flock there because

that‘s where the jobs and knowledge networks are. Firms do the same to tap the talent pool, stay

abreast of advances, and be near suppliers and potential partners.‖ 2

Perhaps one of the best known approaches for place-based strategies to advance technology hubs

is the establishment of university research parks. According to the National Research Council in

its study of research park best practices:

“Research parks are seen increasingly around the world as a means to create dynamic clusters

that accelerate economic growth and international competitiveness. They are widely

considered to be a proven tool to encourage the formation of innovative high technology

companies. They are also seen as an effective means to generate employment and to make

2 Pisano and Shih, op cit.

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existing companies more competitive.” 3

Research parks are real estate developments in which land and buildings are used to house public

and private research and development facilities, high technology and science-based companies,

and support services. By providing a location in which researchers and companies operate in

close proximity, research parks create an environment that fosters collaboration and innovation

and promotes the development, transfer and commercialization of technology. As shown in

Figure 1, ideas flow between the technology generators and the companies located in the research

park. In addition, the innovations technology, and knowledge generated by the companies and

research institutions lead to the creation of new start-up companies. Most research parks are

affiliated with one or more universities; however, research parks have also been developed in

close proximity to national laboratories or other sources of technology and innovation.

Source of innovation

(University, federal laboratories, private R& D facilities)

Job Resources Job Resources

Research Park Tenants Business Incubator

Growth

Graduates and Spin-Offs

Source: Adapted from: ―Positioning Research Parks for Success‖, Guy T. Mascari. Economic

Development Commentary, Vol. 23, No. 4, Winter 2000, p. 38

Figure 1.1.1 Research Park Concept

The Association of University Research Parks defines a university research park as a

property-based venture, which has:

-Master planned property and buildings designed primarily for private/public research and

development facilities, high technology and science based companies, and support services

-A contractual, formal or operational relationship with one or more science/research

institutions of higher education

3 National Research Council, ―Understanding Research, Science and Technology Parks: Global Best Practices‖, 2009.

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-A role in promoting the university's research and development through industry partnerships,

assisting in the growth of new ventures and promoting economic development

-A role in aiding the transfer of technology and business skills between university and industry

teams

-A role in promoting technology-led economic development for the community or region.

For bioresources development, the presence of a signature development complex is especially

important. Among the key added value of having a university research park for bioresources

development are the following:

-Enabling access to specialized lab space. Bioresource development requires highly

specialized lab space, including provision of wet-lab facilities that meet clean room

requirements for sterility. In addition, there is often expensive equipment needed for analysis

and pilot production activity. This specialized lab space is expensive to construct and is not

adequately supported by the commercial real-estate market because of its perceived

specialized use. So, by offering available wet-lab space, along with specialized equipment,

bioresource-focused research parks and other development complexes can be important

resources for attracting and supporting commercial bioresource development.

-Offering close physical proximity and linkages between bioresource product and venture

development and research. Unlike other technology fields, product development in the

bioresources draws more frequently on advances in the basic sciences generated by research

institutions, such as for advances in new drug targets, identification of plant improvements,

advances in biomedical instrumentation for imaging or diagnostics, and identification of

improved medical approaches for treating diseases. Moreover, because of the strict regulatory

environment surrounding the introduction of new therapies and devices for medical treatment,

bioresource research institutions are critical in undertaking clinical research. Therefore,

having physical locations with close ties to bioresource research organizations can provide an

important competitive advantage of proximity.

-Nurturing and fostering new bioresource start-ups. Combining the proximity to research

drivers with the availability of bioresource wet-lab space can foster new bioresource venture

formation that helps move research discoveries with high commercial potential into the

marketplace with a variety of assistance services—such as market analysis, proof of concept,

business planning, management team recruitment, and venture financing attraction.

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-Accessing talent. An important ingredient in the success of a region in the bioresources is to

have an environment that generates, attracts, and retains talent – pools of specialized workers

in bioscience and bioresource utilization. Bioresource-focused developments close to

university and academic health centers can serve as an important intersection of

complementary talents, from bioscience researchers to bioresource company managers to

technicians. More directly, they can leverage students for internships and co-op programs

creating new relationships; increasingly, research parks are also becoming sites for advanced

training programs and specialized educational programs in the bioresources. Finally, through

innovation support activities (such as incubators and testing and applied research facilities),

these bioresource-focused development complexes can be places where more senior faculty

and postgraduate researchers can effectively interface with bioresource entrepreneurs and

existing and emerging companies.

1.2 Competitiveness Analysis for Indonesian Biocluster

1.2.1 Pharmaceutical Industry Platform

(1) Herbal Medicines

1) Definition of Market Niche

An herb is a plant or plant part used for its scent, flavor or therapeutic properties. The

value of herbs for medicinal purposes is that plants synthesize a wide variety of chemical

compounds that have biological function. Chemical compounds in plants mediate their

effects on the human body through processes identical to those already well understood

for the chemical compounds in conventional drugs; thus herbal medicines do not differ

greatly from conventional drugs in terms of how they work. Scrutiny of medical

indications by source of compounds has demonstrated that herbal medicines and other

natural products found among living organisms (such as microbes) are used to treat 87%

of all categorized human diseases, including their use as antibacterial, anticancer,

anticoagulant, antiparasitic, and immunosuppressant agents, among other applications4.

Typically herbal medicines are provided as nutritional supplements, where the active

ingredient for medicinal purposes is identified and then extracted into tablets, capsules,

and powders, as well as drinks and energy bars.

Often the active medicinal ingredient found in herbal medicines can be the basis for what

is known as natural product drug development. The small active molecules identified by

4 Newman DJ, Cragg GM, Snader KM, ―Natural products as sources of new drugs over the period 1981–2002,‖ Journal of Natural Products, 2003, pages 1022–1037.

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herbal medicine provide a lead for developing a synthetic chemical agents for

pharmaceuticals.

This could involve producing synthetic versions of the simplified bioactive molecules

found in herbal medicine or using the bioactive molecule to guide the production of

synthetic small molecule libraries that are more amenable to high throughput screening.

Modern automated fractionation and characterization methods to improve screening, new

molecular modeling programs to guide modification of natural products, and engineering

strategies for production of natural products in organisms are helping to make natural

product drug discovery and development once again a rational path for industrial

application.

2) Existing Market and Competitive Position of Indonesia

Indonesia is an ideal market the production and use of herbal medicines.

There is a strong cultural acceptance of herbal medicines for treating diseases. Indeed,

there is even a specific Indonesian word for herbal medicine, Jamu.

On the production side, the significant diversity of plants in Indonesia offers a wide range

of opportunities for herbal medicine development. This has lead to significant value in

ethnobotany study since herbal medicines have a long tradition of use in Indonesia and,

because of the nation‘s extensive biodiversity, are richly available. The Indonesia

Ministry of Health in its 2007 Report on National Policy on Traditional Medicines

reported that there are approximately 40,000 species of plants in Indonesia and among

them at least 9,600 species of plants have been used as medicines. In addition, there are

400 ethnic groups in Indonesia that possess traditional knowledge, accumulated over

centuries, regarding the use of plants for medicinal purposes.

It is reported that there are already over 1,200 producers of herbal medicines in Indonesia.

This is an area of particularly significant small and mid-sized business development and

an active sector for development in rural areas of Indonesia.

Among the competitive challenges for Indonesia to grow its herbal medicine industry are:

-Reaching significant scale in the identification and assessment of different plants used

traditionally for herbal medicines.

- Improving the quality standards of herbal medicine producers, particularly in light of

ongoing Association of Southeast Asian Nation (ASEAN) harmonization efforts to

standardize technical requirements on safety, efficacy, stability, good manufacturing

practices and labeling related to herbal medicines. It is expected that these

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harmonization regulations will be put in place in 2014 and fully implemented by

2015.

(2) Biopharmaceuticals for Diagnostics, Vaccines and Antibiotics

1) Definition of Market Niche

Biopharmaceuticals involve therapies, medical products and diagnostics that are

produced or engineered using biotechnology methods and technologies. Among the

common biopharmaceuticals on the market today are vaccines, biotech-engineered

antibodies, protein-based and nucleic-acid-based drugs, and other biologics involving

cell or tissue based products (e.g. stored packed Red Blood Cell units).

The production process of biopharmaceuticals varies significantly from traditional

chemical-based pharmaceutical drugs. Biopharmaceuticals are manufactured in living

systems such as microorganisms, plants, or animal cells using fermentation systems that

grow or scale-up the biological-based product. A growing area of biopharmaceuticals

for emerging nations is the equivalent of producing generic chemical-based

pharmaceuticals for vaccines, diagnostics and biotech-engineered therapies that have

come off patent. This generic impersonation of biopharmaceuticals is called

―biosimilars‖.

Unlike generic chemical-based pharmaceuticals, biosimilars are far more difficult to

produce, reflecting both the greater molecular complexity of a large molecule biologic,

such as a therapeutic protein or monoclonal antibody, and a major difference in

production process involving fermentation of cell lines or what is often referred to as

bio-scale-up manufacturing. In fact, the generic biopharmaceutical manufacturer will not

have access to the original cell line, nor will the generic biologic manufacturer know the

exact fermentation or purification process used. So the imprecise nature of getting to an

exact copy will result in far greater testing requirements. The Economist reports that the

cost of a biosimilar might reach as much as $100 to $150 million5.

2) Existing Market and Competitive Position of Indonesia

The near term focus for biopharmaceuticals in Indonesia is for vaccines to treat

communicable diseases. The World Health Organization reports that communicable

diseases continue to be the major cause of morbidity and mortality in Indonesia. Plus,

the possibility of emerging diseases with epidemic or pandemic potential is a major

concern in Indonesia.

Indonesia stands out in having a state-owned company, PT Bio Farma, serving as a

5 ―Attack of the Biosimilars,‖ The Economist, October 23, 2010, page 78.

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producer of vaccines, sera and diagnostic products. Bio Farma was the first ASEAN

based vaccines manufacturer to achieve WHO prequalification status, enabling

participation in UNICEF tenders for DTP, DTP-HepB, HepB, measles and oral polio

vaccines. Bio Farma remains active in vaccine development, with its recent development

of a pandemic flu vaccine in collaboration with the Biken Institute of Japan and a

pentavalent child vaccination with support from the GAVI Alliance, which contains five

antigens in one shot and protects against diphtheria-tetanus-pertussis (DTP), hepatitis B

and Haemophilius influenzae type b (Hib).

Bio Farma is also active in exporting, with a reported 60% of its products sold as exports.

This potential to serve the global market is significant. In 2010, both the adult vaccine

market and pediatric vaccine market exceed $12 billion, and both are expected to grow

significantly in the 8 to 10 percent annual range over the next few years. In addition,

there are substantial advances in vaccines that are nearing market introduction for unmet

needs in malaria, dengue fever, herpes, and diabetes, among other conditions.

Worldwide the vaccine market is dominated by five companies - Sanofi,

GlaxoSmithKline, Merck & Co., Pfizer, and Novartis – who hold close to 80% of the

world market. Several of these companies market vaccines. In addition, the Novartis

Institute for Tropical Diseases has established a clinical research initiative in Indonesia

focused on treatments for tuberculosis, dengue fever and malaria in collaboration with the

Eijkman Institute and the Hasanuddin University Clinical Research Institute.

(3) Pharmaceutical Raw Materials

1) Definition of Market Niche

The making of a chemical-based pharmaceutical drug requires two types of raw

materials:

-Active pharmaceutical ingredients (API), which are the active chemical components

providing the pharmacological activity of a drug. Active ingredients include those

components of the product that may undergo chemical change during the manufacture

of the drug product and be present in the drug product in a modified form intended to

furnish the specified activity or effect.

-Excipients, or non-active materials that help to package and deliver a drug. Examples

of excipients include fillers, extenders, diluents, wetting agents, solvents, emulsifiers,

preservatives, flavors, absorption enhancers, sustained-release matrices, and coloring

agents.

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Firms involved in producing pharmaceutical raw materials act as a bridge between the

upstream chemical industry and the downstream pharmaceutical drug industry.

2) Existing Market and Competitive Position of Indonesia

Estimates suggest that well over 90% of the more than 1,000 raw materials used to

manufacture drugs in Indonesia are imported. Two key sources are China and India.

Not having pharmaceutical raw materials produced in Indonesia is a concern for the

overall competitiveness of Indonesia‘s pharmaceutical industry. It raises risks for

Indonesia from currency fluctuations as well as changing internal demand patterns within

other nations and other nations‘ shifting export strategies.

A challenge for Indonesia in advancing pharmaceutical raw material production is that it

must meet Good Manufacturing Practices (GMP) for safety and quality assurance. This

raises the cost of market entry.

In addition, price controls on pharmaceuticals raise barriers for new participants entering

the pharmaceutical raw material industry.

Finally, new Indonesian participants in manufacturing pharmaceutical raw material

would need to compete with the established strong production capacity found overseas,

especially in China, the world‘s largest producer of pharmaceutical raw materials. Over

the years, China‘s pharmaceutical raw materials manufacturers have been very active in

exporting.

1.2.2 Agriculture and Food Platform

(1) Agricultural Improvement and Diversification

1) Definition of Market Niche

Agricultural improvement is focused on achieving rising levels of crop productivity in

the face of mounting challenges posed by plant pathogens, pests, salinity, drought,

flooding, nutrient deficiency or toxicity of soil.

In addition, agriculture needs to keep pace with shifting consumer demand and

purchasing power and global market opportunities. Basic staple commodities such as

rice or maize do not lend themselves to generating higher incomes for farmers or meeting

the consumer demand of a rising middle class. The focus of value-added agriculture is

to diversify crops via identification of niche market opportunities and to increase farm

incomes.

2) Existing Market and Competitive Position of Indonesia

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Food crops in Indonesia comprise slightly over 7 percent of gross domestic product and

rose by nearly 30% in real terms from 2004 to 2010. As noted, agriculture remains an

important economic driver for Indonesia. The value of its production has increased

faster than population growth and it is a major employment sector for Indonesian

workers.

Reflecting this growth in agriculture, farmer incomes in Indonesia have risen

significantly over the past decade, and have been an important contributor to lowering

poverty in the country.

Generating increasing agricultural productivity is of particular importance to Indonesia

since the nation has limitations on its agronomic land. At just 0.23 ha per person, which

is a third of the world‘s average, agronomic land is a particularly scarce resource so

having high agricultural productivity is a critical factor. Pressing more land into

production is considered to be a poor option for the nation since it would require

deforestation and the loss of critical biodiversity (which, as noted above, is relevant to

development of other economic sectors).

Current rice yields in Indonesia of 5 tons per ha in 2009 compare favorably with other

nations, such as Thailand, India and Malaysia, though it is below the 6.6 tons per ha

achieved by China. Yet in recent years there have been relatively low productivity gains

in yields for rice. In comparison, fruit and vegetable output has not only been growing,

but has been recording significant growth in yields.

One particular challenge facing Indonesia in raising agricultural productivity is that its

crop production is based on quite small farms using predominantly manual labor and little

mechanization.

Indonesia is also facing considerable environmental challenges in regards to maintaining

its existing agricultural productivity, particularly for rice production, including:

-Soil erosion: Due to intensive rice cultivation practices, particularly in irrigated land,

there is a tendency toward declining soil quality in rice producing provinces. Heavy

application of inorganic fertilizers over long periods of time has resulted in worsened

soil structure and significant water pollution, particularly in Java. In swampy land, the

problem lies mainly in the high level of acidity due to improper land and water

management practices.

-Climate change: Already maximum and minimum temperatures have steadily

increased with impacts on rainfall detected across Indonesia, with some areas

decreasing, while others have experienced increases. The date of Monsoon onset has

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also changed in many parts of Indonesia with increasing delays in some regions.

The implications of climate change for rice production are of significant concern. The

rice-rice system, which is the current cropping pattern used in most of the rice growing

areas, may no longer be the most effective production approach in the near future. As

the second planting depends heavily on irrigation water, under extreme drought years this

might become increasingly limited and lead to major production losses.

Also the rising temperatures from climate change impact on rainfall patterns and in the

length of seasons is causing concerns about the development of crop pests and diseases.

At the same time, agro-food production in Indonesia continues to diversify with strong

growth in fruits and vegetables in recent years. While domestic consumption of fruits

and vegetables is on the rise, Indonesian production of tropical fruit is a growing area of

exports. Today, Indonesia is first in the world in the exports of coconuts and third in the

world in pineapple, papayas and other tropical fruit exports. Still, in overall trade of

fruits and vegetables, Indonesia has not kept-up with demand and has also been held back

by weak marketing linkages between expanding and modernizing urban food retailing

and the base of small-scale farmers in Indonesia.

(2) Value Added Food Products

1) Definition of Market Niche

The quality of food has acquired a renewed emphasis with the increased awareness of

optimal nutritional requirements and the consequences of poor nutrition (such as obesity

or vitamin deficiency). The food industry has responded with foods engineered for

nutritional advantages. Examples include fiber enhancements for yogurt, probiotic

ingredients, omega-3 enriched eggs, and specialized sports drinks to name just a few.

At the same time, illness from pathogen contaminated foods, and the concern of

bioterrorism resulting in contaminated food sources, have also increased. This need for

enhanced food safety and security is providing opportunities for the development of

pathogen detection systems, fast turn-around diagnostics technologies, decontamination

technologies and advanced packaging systems.

2) Existing Market and Competitive Position of Indonesia

The food industry in Indonesia is a significant economic driver. Food products comprise

7.3% of gross domestic product, grew by 35% in real terms from 2004 to 2010 and

involve over 5,000 business establishments.

Market research studies note a trend towards healthier food consumption, especially

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amongst middle- and upper-income Indonesians and urban residents, who are more

exposed to health issues. Rising health consciousness was partly driven by increasing

coverage of health issues in newspapers, magazines and on television. In addition,

packaged food manufacturers continued to invest heavily in launches of new health and

wellness brands and promotional activities that emphasized the health benefits of their

products. 2012 continued to witness a number of products launched with vitamin

fortifications, healthy ingredients, suitability for weight watching, lower sugar, lower

cholesterol, and lower fat content characteristics in both retail packaged food and

foodservice outlets.

Multinationals have a strong foothold in the Indonesian food products industry. This

includes Heinz ABC Indonesia, Kraft Foods Indonesia and So Good Food. In 2012, these

multinationals continued to invest heavily in new launches and promotions. For example,

Heinz ABC launched ABC KecapPedas or spicy soy sauce and held road-shows in major

cities as well as in-store promotions in modern retail outlets. Besides launching Oreo in

new orange ice cream flavor, Kraft Foods actively promoted its packaged food products

through social media such as Facebook and Twitter. Meanwhile, So Good Food had just

established its fourth processing factory, adding larger production capacity to meet

consumers‘ demand.

1.2.3 Industrial Bioproducts Platform

(1) Palm Oil Bioproducts

1) Definition of Market Niche

Advancing the full range of bioproduct development opportunities from palm oil. Palm

oil can be separated into a wide range of distinct oils with different properties. This

versatility has seen palm oil replace animal and other vegetable oils in a wide variety of

products. Today it is: 6

-used as a cooking oil

-the main ingredient for most margarine

-used in confectionary, ice cream and ready-to-eat meals

-the base for most liquid detergents, soaps, and shampoos

-the base for lipstick, waxes, and polishes

-used as an industrial lubricant

-used as a biofuel.

6 Source: World Wildlife Fund. http://wwf.panda.org/what_we_do/footprint/agriculture/palm_oil/about/

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2) Existing Market and Competitive Position of Indonesia

Indonesia is the top palm oil producer in the world producing 18 million tonnes (40%) of

the global production of 45 million tonnes.

More than 70% of Indonesia‘s palm oil is exported. The main destinations countries are

India, the Netherlands, Malaysia, Italy, Singapore, Germany and China.

While large scale private companies produce over 50% of Indonesian palm oil, a

significant share representing 35% of palm oil production is still with small land holders,

but their yields are lower than for corporate and government plantations.

In 2007, a report prepared for the Stern Review estimated the return from palm oil

land-use as ranging from US$960/ha to US$3,340/ha. This was in comparison with

smallholder rubber, rice fallow, cassava, and one-off timber harvesting which yielded

US$72/ha, US$28/ha, US$19/ha and US$1,099/ha, respectively. Specifically, land-use

returns for palm oil were estimated as including7:

-US$ 960/ha for low yield independent growers;

-US$ 2,340/ha for high yield independent growers;

-US $2,100/ha for supported growers; and

-US $3,340/ha for large scale growers.

There is considerable room to significantly enhance yields of palm oil in Indonesia. In

Indonesia, palm oil yields averaged 3-4 tonnes/ha, however, various estimates of

potential yields are up to 8.6 tonnes/ha.

Currently most of the palm oil leaves Indonesia with no value-added beyond the milling

stage (which produces crude palm oil and has to be done close to the plantations to avoid

spoilage). About 60% of production is shipped in crude form, with limited value-added

by the country of origin.

Current Indonesia government policies are encouraging biodiesel production from palm

oil. The government has set minimum requirements for the use of biodiesel in

transportation and electricity production of 20% by 2025. In addition, export duties are

lower on biodiesel from palm oil than on crude palm oil. And a range of incentives have

been put in place including VAT exemption, investment tax incentives, simplified

licensing procedures and loan interest subsidies.

Among the leading players are Bakrie Sumatra Plantation, London Sumatra, Astra Agro

Lestari, SMART and Darmex. In 2011, 49 private companies were granted investment

7 Ibid

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approval with a total investment of $US 1.5 billion and a combined production of 96.5

million tons.

1.3 Survey of High Potential Sector for Research and Investment

1.3.1 Approach to Informing Identification of Targets of Opportunity for Industrialization

The first step in assessing targeted opportunities for industrialization around university-associated

research parks is to consider how Indonesia is positioned in bioresource-based industry today in

areas of development with linkages, or potential linkages, to university research and development

activities and capabilities.

The approach undertaken for identifying potential industrialization targets used field work to

understand the potential opportunity set relative to the research activities and capabilities found

across BPPT, ITB and IPB. In addition, Battelle analysts examined market research, academic

publications and intellectual property data in comparison to identified research institution

capabilities. Based on Battelle‘s review, three key industry platforms stand out as high potential

sectors for advancing the development of industry collaborations around the new academic

research clusters in bioresources for Indonesia:

-Pharmaceutical platform involving bioprospecting for natural products and herbal

medicines; the production of diagnostics, vaccines and antibiotics; and pharmaceutical raw

materials.

-Agriculture and Food platform involving primary agricultural improvement and

diversification as well as value added food products.

-Industrial bioproducts platform focused on bio-oils, biofuels and biorefining operations

with a particular emphasis on adding-value to palm oil as a principal feedstock.

An assessment of each of the above platforms was performed in terms of their respective potential

for industrialization based on review of market research reports and other studies on bioresources

industries. It is particularly important in considering the potential for industrialization to

distinguish between two development pathways: industrialization to provide domestic production

that substitutes for imports, and industrialization that develops growing industries with the

potential to serve export markets. In addition, outreach to industry was undertaken, incorporating

interviews with key industry representatives, to learn of their interests and needs going forward.

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For each of the specific platforms, an industry platform profile has been developed that considers:

-Target market niches

-Types of development Impacts expected for Indonesia

-Fit to a university research park

-Target markets to be served

-Market size and growth

-Industry development barriers and issues in Indonesia

1.3.2 Pharmaceutical Industry Platform

The pharmaceutical industry is focused on the development and production of medicines and

diagnostics that save, sustain and improve lives. The traditional pharmaceutical industry, which

was predominant through most of the 20th century, relied upon on identifying small chemical

molecules to act mainly as blockers or inhibitors of biological processes involved in disease.

Much of the discovery of traditional pharmaceuticals was based on identifying the active

ingredient from long-standing remedies or by serendipitous discovery. Bioactive natural products

and phytochemical compounds have been a traditional source of a significant majority of

marketed drugs.

More recently, the advent of biotechnology has reshaped many aspects of biomedical

development from the way we study medicine, discover and develop therapeutics, and diagnose

and treat diseases and medical conditions. Simply put, biotechnology involves techniques to

understand and manage the machinery of living things. It was launched by two key discoveries in

the 1970s involving the manipulation of living cells at a molecular level, including moving

genetic information from one living cell to another, a technique known as recombinant DNA, and

fusing cells to produce disease-fighting antibodies, or what is known as monoclonal antibody

technology. This has lead to a new class of drugs, known as biopharmaceuticals that directly

utilize biological agents, such as proteins, antibodies, DNA and RNA, as therapeutic

interventions.

Biotechnology has also changed the way targets for new drugs are developed even for small

chemical agents. Now drugs are developed based on research which elucidates how diseases and

infections are controlled at the molecular and physiology level. This knowledge is then used to

identify new potential targets for intervention in disease pathways. These modern biotechnology

methods for drug discovery and development have been supported by a range of new technologies,

such as computer-aided modeling, combinatorial chemistry techniques involving the generation

of large collections, or libraries,‖ of compounds by synthesizing all possible combinations of a set

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of smaller chemical structures or ―building blocks,‖ and use of high throughput screening in

which hundreds or thousands of chemical targets can be analyzed for bioactivity. Moreover,

computer modeling and computational chemistry techniques are assisting in the pharmacological

study of drugs to improve drug design for absorption, distribution, metabolism, excretion and

toxicity. Thus, today drug discovery can be much more targeted and go from a detailed

understanding of the biological processes and related proteins to the structure of proteins to

designed chemical agents to act on the disease process.

In Indonesia, the pharmaceutical market is dominated by generic prescription drugs and

over-the-counter medicines based primarily on traditional small molecule, pharmaceutical

chemical agents. Generic drugs are those that have typically been developed by another

producer/innovator, are no longer protected by a patent, contain the same active substance as the

original drug, and have the same quality, safety and therapeutic efficacy as the original patented

product. Over-the-counter medicines, meanwhile, do not require a prescription, because they are

generally considered to be sufficiently safe for the general public to determine when to use.

Market research studies estimate the overall pharmaceutical market in Indonesia to have reached

$US 5 to $US 6 billion in 2012 and the market is expected to grow over the next 5 to 7 years at a

healthy rate of 7.6% to 9% annually. In 2012, the share of generic prescription drugs and

over-the-counter medicines were each approximately 40% of the total pharmaceutical market.

The remaining 20% of the Indonesian pharmaceutical market in 2012 was comprised of patented

prescription drugs. These patented drugs are nearly all supplied by foreign pharmaceutical firms.

The basis for these patented drugs is an environment with a robust new drug discovery and

development capacity, and few Indonesian companies or universities have the capacity to

discover new chemical or biological agents, especially based on modern biotechnology methods.

It is also expensive to discover and develop new patented prescription drugs, with a high failure

rate along the way, and so the price of patented prescription drugs can be quite high. Finally,

there are concerns about intellectual property protection in Indonesia for foreign-developed drugs,

which serves as a disincentive for many foreign companies to bring patented prescription drugs to

Indonesia.

While there is not significant activity in Indonesia in modern biotechnology approaches for the

discovery of novel drugs, there are still areas of research and development that can support the

pharmaceutical industry in Indonesia, both to meet local needs as well as for generating exports.

These three market niches for industrialization in pharmaceutical drugs include:

(1) Herbal medicines

(2) Biopharmaceuticals for diagnostics, vaccines and antibiotics

(3) Pharmaceutical raw materials

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(1) Herbal Medicines

Table 1.3.1 Target Markets and R&D Collaboration Fields for Herbal Medicines

Target Markets for

Indonesia

Industrialization

Herbal medicines offer opportunities for expansion within Indonesia as well

as for export to other nations.

There is already a well established market in Indonesia for herbal

medicines. It is estimated that the size of the herbal medicine market in

Indonesia is valued at between $US 1 billion to $US 2.7 billion annually,

and covers a wide range of products.

Indonesian herbal medicines are also becoming an export producer for

Indonesia, now reaching above $US 200 million. Key nations importing

Indonesian herbal medicines include South Korea, Taiwan and Hong Kong.

There is also trade with Middle East and Russia.

The worldwide market for herbal medicines is estimated to be over $US 7

billion and is growing at a moderate rate of approximately 4% annually.

Among the major uses are for enlarged prostate conditions, cognitive

disorders and menopausal symptoms.

Another industry application of herbal medicines is to guide drug discovery

and development. Natural products continue to comprise a large share of the

top selling drugs worldwide. Comparisons of the information presented on

sources of new drugs from 1981 to 2007 indicate that almost half of the

drugs approved since 1994 are based on natural products. Thirteen natural

products related drugs were approved from 2005 to 2007, and five of these

represented the first members of new classes of drugs. Moreover, the

pipeline is not dropping off. Over 100 natural product derived compounds

are currently undergoing clinical trials and at least 100 are in preclinical

development.8

Fit for Industry

R&D

Collaborations

with Universities

Universities can offer many high value-added services for advancing herbal

medicine, including:

Conducting the ―ethnobotany‖ studies of various plants to learn of

the traditional human uses of plants for medicinal purposes. This

8 Allan Harvey, ―Natural Products in Drug Discovery,‖ Drug Discovery Today, October 2008, page 894.

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represents a well-recognized and effective way to discover future

medicines.

Identifying and characterizing the bioactive ingredient using

analytical chemistry techniques.

Screening the bioactive ingredient against various diseases.

Advancing extraction approaches that can be standardized.

Studying the toxicology of the bio-active ingredient

Advancing the formulation of the bio-active ingredient within a

nutritional supplement or medical products

Testing the bio-activity within a nutritional supplement or medicinal

product.

Industrialization

Barriers for

Indonesia

Gaining acceptance of herbal medicine requires rigorous efficacy studies.

This calls for both laboratory-based in vitro studies as well as human-based

clinical studies. These need to be conducted at a very high standard to gain

acceptance for

Source: JICA Study Team

(2) Biopharmaceuticals for Diagnostics, Vaccines and Antibiotics

Table 1.3.2 Target Markets and R&D Collaboration Fields for Biopharmaceuticals for

Diagnostics, Vaccines and Antibiotics

Target Markets

for Indonesia

Industrialization

Vaccine production is a significant public health need within Indonesia. By

virtue of advancing local capacity, Indonesia can also serve many in the

developing world as is currently being done by Bio Farma. Globally the

vaccine market stands at more than $25 billion and is expected to have

healthy annual growth of 7% or higher. The leading vaccines include those

for pneumococcal, influenza, diphtheria, whooping cough, polio, chickenpox

and HPV. Meanwhile, a number of important vaccines are making their way

through later stage clinical trials, such as for dengue and malaria.

Looking to the future, Indonesia will face the need to shift towards more

biosimilar production. Biotechnology-based drugs are growing in

importance. By 2014 the top six best-selling drugs will be biotech products

compared to five in 2008 and just one in 2000, plus biotech drugs will account

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for 50% of the top 100 drugs in 2014, compared to just 28% in 2008 and 11%

in 2000.9 New biopharmaceuticals for treating blood disorders, cancer,

infectious diseases, autoimmune diseases, inflammatory diseases, and

diabetes comprise much of the global clinical pipeline for new therapeutics

and are expected to reach the marketplace within the next decade.

Fit for Industry

R&D

Collaborations

with Research

Institutions

Since biopharmaceuticals require expert knowledge of biological processes

and biology-driven scale up manufacturing, there is a strong fit for industry to

leverage the expertise and facilities found in universities and other research

institutions to advance the development of even biosimilars. Novel

biopharmaceutical development is even more dependent upon university and

research institution knowledge and often requires access to clinical partners

for access to biospecimens and knowledge of diseases.

Having the NARC on bioresources focus on biopharmaceutical development

and production in collaboration with local companies is endorsed by local

industry in Indonesia. There is currently a lack of facilities to expand

production, particularly for vaccines and diagnostics.

Industrialization

Barriers for

Indonesia

Given the more sophisticated requirements of biopharmaceuticals, few local

companies have the expertise to produce them.

Potential partnerships with foreign biopharmaceutical companies present

challenges due to:

Market access barriers in Indonesia

Foreign ownership limits for activities in Indonesia

Patent coverage and implementation of TRIPS.

Source: JICA Study Team

(3) Pharmaceutical Raw Materials

Table 1.3.3 Target Markets and R&D Collaboration Fields for Biopharmaceuticals for

Pharmaceutical Raw Materials

Target Markets for

Indonesia

Industrialization

The advancement of pharmaceutical raw material industrialization in

Indonesia is largely an import substitution strategy in the near term.

The growth prospects for the industry are driven by the overall growth

9 EvaluatePharma, ―Biotech Set to Dominate Drug Industry Growth, June 17, 2009.

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potential of pharmaceuticals in Indonesia. Various market research studies

estimate the overall pharmaceutical market in Indonesia to have reached

$US 5 billion to $US 6 billion in 2012 and this market is expected to grow

over the next 5 to 7 years at a healthy rate of 7.6% to 9% annually. In

2012, the share of generic prescription drugs and over-the-counter

medicines were each approximately 40% of the total Indonesian

pharmaceutical market. So, this seems very promising for advancing

pharmaceutical raw materials manufacturing.

The key customers for pharmaceutical raw material production in Indonesia

would be Indonesian pharmaceutical firms manufacturing chemical-based

drugs in Indonesia, which are primarily generics.

It is not clear whether international pharmaceutical companies

manufacturing in Indonesia would source their raw materials from

Indonesian suppliers.

One way to support both local and international companies would be to

attract foreign investment in new joint ventures for pharmaceutical raw

material production. This is what happened in the Chinese market, where

by 2012 foreign owned companies had nearly one-quarter of the market for

pharmaceutical raw materials. Examples of such foreign industry

investment in China for pharmaceutical raw materials include DSM from

the Netherlands as well as BASF and Bayer Group from Germany entering

into separate joint ventures in China.

Over time, as patent expirations mount and the growth of generic drugs

advances, there is a growing global contract manufacturing market for

pharmaceutical raw materials that Indonesian firms could target for exports.

This is especially the case if specific niches can be identified in novel APIs

or drug delivery materials and technologies. The size of the global contract

manufacturing market for pharmaceutical raw materials is estimated to be

well over US$ 50 billion in 2012 and its growth over the next several years

is expected to be in the 5% to 7% range.

Fit for Industry

R&D

Collaborations

with Universities

Since most products manufactured by the industry are generic, competition

is intense and profit margins are narrow. It is therefore essential that

enterprises develop products with differentiation in new fields or distinctive

bulk pharmaceuticals with special usage.

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Universities may play an important role in advancing competitive

advantages for Indonesian pharmaceutical raw material companies through

the development of novel active pharmaceutical ingredients, innovative

formulation technologies or advancing novel drug delivery methods such as

through the use of nanotechnology.

Industrialization

Barriers for

Indonesia

For Indonesia to become a player in pharmaceutical raw materials the

national government would need to provide investments in R&D and

production incentives.

Source: JICA Study Team

1.3.3 Agriculture and Food Platform

Agriculture and food is a significant sector of Indonesia‘s economy. ―The Master Plan for

Acceleration and Expansion of Indonesia Economic Development 2011-2025‖ indicates the

importance of agriculture and food as an economic driver in Indonesia, aiming to position

Indonesia ―as one of the world‘s main food suppliers, as a processing center for agriculture.‖

The recent OECD Review of Agricultural Policies: Indonesia 2012 sets out the importance of the

agricultural sector in Indonesia:

- With an average value of agricultural production at $US 66 billion in 2007-2009, Indonesia is

the world‘s 10th largest agricultural producer.

- Employment in agriculture remains stable at approximately 42 million workers, representing

40% of total employment in Indonesia in 2009.

- Overall, between 1990 and 2009, agricultural output increased by 97%, compared with a

population growth of 29% over the same period indicating a significant increase in production

per capita.

- In rice production, Indonesia is the third largest producer in the world after China and India.

Indonesia is practically self-sufficient in rice production with occasional imports playing a

marginal role in meeting domestic demand. Rice production increased more than four times

from 1961 to 1990, and has since been growing more in line with Indonesian population

growth.

-At the same time, fruit and vegetable production has grown significantly. From 1990 to 2010,

fruit production increased 2.5 times and vegetable production doubled.

The continued advancement of the agriculture and food sector in Indonesia, though, faces many

threats and development challenges, which places significant importance on two focus areas for

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industrialization:

- A continued need for agricultural productivity improvement via plant breeding, soil

enhancement and biocontrol agents, as well as diversification into broader range of

higher-value agricultural products such as fruits and vegetables.

- Opportunities for value-added agriculture to create higher nutritional-value food products and

to improve food safety.

(1) Agricultural Improvement and Diversification

Table 1.3.4 Target Markets and R&D Collaboration Fields for Biopharmaceuticals for

Agricultural Improvement and Diversification

Target Markets for

Indonesia

Industrialization

Generally, the focus on agricultural improvement is largely a domestic

industrialization focus for Indonesia.

One of the key products of agricultural improvement is developing

enhanced seeds to address changing environmental conditions.

The seed industry is dominated by government agencies or state

companies that produce and multiply seed for rice and other crops.

The private seed industry in Indonesia focuses on estate crops for

spices, hybrid corn and some high-value horticultural crops. In

horticulture, private companies are active in providing seeds for

production that is exported or processed into high-valued products

under contracts with local farmers.

There is an export opportunity with the continued strong demand for

tropical fruits. According to a UN Food and Agriculture Organization

presentation on Market Prospects, Opportunities and Challenges for

Tropical Fruits, there should be significant growth in fresh tropical fruit

demand:

A significant development is the increasing share of fresh

compared to processed fruits traded, taking advantage of advances

in post harvest technology.

These developments have enabled tropical fruits to compete at the

upper end of the market, maximizing earnings through the sales of

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fresh fruit in a segment where unit prices are at a premium.

Tropical fruit markets have evolved significantly. Price

premiums based on novelty have been replaced by quality based

premiums.

Major challenges for future market growth are related to

coordinated management of the field-to market-supply chain.

Issues related to food safety, pest and disease control as well as

quality should find a proper balance between cost and demand.

Fit for Industry

R&D

Collaborations

with Universities

University and research institutions efforts in plant science offer significant

opportunities for addressing the need for rising agricultural productivity

and advancing agricultural diversification. Plant sciences offers a broad

scientific discipline incorporating a range of plant/ botanical research

including plant breeding, developmental and cell biology, biochemistry

and physiology, morphology and structure, systematics, plant-microbe

interactions, and ecology. Applied plant science engages crop

development and plant improvement, including breeding and improved

soil conditions.

Industrialization

Barriers for

Indonesia

There do not appear to be significant barriers. Government policy in

Indonesia is currently supportive of agricultural improvement. Since 2000

agriculture policy in Indonesia has reintroduced and greatly expanded

fertilizer and seed subsidy programs and placed an emphasis on extension

services with the establishment of a unified extension service and increase

in the number of extension workers.

One limitation for agricultural improvement is the low level of research

and development investment in Indonesia. Agricultural research intensity

– defined as the ratio of public and private R&D expenditures over total

agricultural output – stood at 0.27% in 2009, which stands at the lower end

among Asian nations.

Source: JICA Study Team

(2) Value Added Food Products

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Table 1.3.5 Target Markets and R&D Collaboration Fields for Biopharmaceuticals for Value

Added Food Products

Target Markets for

Indonesia

Industrialization

Value-added food products represent both a domestic and export market

opportunity for industrialization.

It is estimated that the global functional foods market will be $90.5 billion

in 2013, while the world market for functional foods and drinks is expected

to reach $130 billion by 2015. Market growth is fueled by product

innovation and increasingly health-conscious consumers with higher

disposable incomes.

Fit for Industry

R&D

Collaborations

with Universities

To advance functional foods and food safety requires knowledge of food

and nutritional sciences, microbiology, biotechnology and analytical

chemistry. Research is critical for characterizing, separating, purifying,

and processing bio-active chemicals in agricultural commodities and

byproducts and developing new technologies to create health-promoting

foods, as well as for identifying and mitigating food pathogens.

This often will require specialized laboratory equipment as well as

scale-up processing technologies.

Industrialization

Barriers for

Indonesia

None identified

Source: JICA Study Team

1.3.4 Industrial Bioproducts Platform

Plant and animal biomass resources have been used by humans for many thousands of years,

primarily for food and feed. Notably, some crops have provided a fiber feedstock, while forest

biomass has been the primary resource for the pulp/paper industries, and plant oils/animal fats

have been the raw materials for the oleochemical industry. More recently, the flexibility of plant

biomass, in combination with modern advancements in processing and conversion technologies,

is driving rapid progress in the utilization of biomass as a feedstock for a variety of new and

expanded industrial uses. This industrial bioprocessing is greatly expanding product opportunities

from renewable resources.

Among the industrial uses of biomass are: electricity generation via direct combustion and

gasification applications; bioderived oils and sugars are being used in the manufacturing of a

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range of liquid biofuels; and manufacturing of innovative materials, including specialty

chemicals and plastics. In addition to the use of biomass as an industrial feedstock, plants also are

being modified to produce specialized human health products such as functional foods and

nutraceuticals and as ―factories‖ for the production of pharmaceutical and industrial products.

For Indonesia, the principal biomass feedstock for industrial products is found in its agricultural

production of palm oil derived from the fruit of the oil palm tree. Oil palm trees produce the

highest oil yield of any current oil seed crop. They have 10x the oil yield of soybeans for

example.

There are other emerging opportunities as well for industrial bioproducts in Indonesia. An

exciting area is in micro/macro algae development, which has the potential to be even more

productive per hectare than palm oil. These efforts in algae development are still in the nascent

stage and so do not represent a prime target for industrialization at this time.

For the near-term, targeting palm oil for its full range of bioproducts can be of significant value in

the industrialization of Indonesia.

Palm Oil Bioproducts

Table 1.3.6 Target Markets and R&D Collaboration Fields for Biopharmaceuticals for Palm Oil

Bioproducts

Target Markets

for Indonesia

Industrialization

Indonesia‘s biodiesel sector maintained healthy growth in 2012. Biodiesel

production increased from 1.575 billion liters in 2011 to 2.2 billion liters in

2012. Exports of biodiesel registered a strong export growth of 22 percent

from 1.225 billion liters in 2011 to 1.5 billion liters in 2012 – with nearly

90% going to Europe.

World production of palm oil is expected to increase by 32% to almost 60

million tonnes by 202010

.

Demand for palm oil has increased in recent years as many developed

economies are shifting away from the use of trans-fats, to healthier

alternatives. Palm oil is often used as a substitute for trans-fat as it is one of

the few highly saturated vegetable fats that are semi-solid at room

temperature, and is relatively low cost.

There is considerable room for further penetration of palm oil in biodiesel

10 Best report source is ―The Economic Benefit of Palm Oil to Indonesia‖. 2011. Produced by World Growth.

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production (where it has a low level of usage currently, despite high yield of

oil).

A hundred kilograms of oil seeds typically produce 20 kilograms of oil,

while a single hectare of oil palm may yield 5,000 kilograms of crude oil, or

nearly 6,000 liters of crude oil that can be used in biodiesel production. At

$400 per metric ton, or about $54 per barrel, palm oil is competitive with

conventional oil.

Biodiesel consumption is predicted to increase significantly globally with

various nations implementing blend mandates. Blending targets for

bio-diesel ranging from 2 percent in the Philippines to 10 percent in the

European Union, by 2020. The OECD estimates if such blending mandates

are enforced an extra 4 million hectares of oil palm would be needed to meet

European Union requirements alone. A further one million hectares may be

needed to satisfy China‘s requirements, making bio-fuel production even

more attractive.

Although palm oil currently accounts for less than 5 percent of the world‘s

bio-diesel production, demand is likely to increase as economies adopt

policies that encourage the use of bio-fuel. Despite a relatively low market

share, palm oil is often used as feedstock in bio-diesel production, and as

feedstock represents the major cost of production, a bio-diesel industry is a

viable option for Indonesia.

However, we heard in Indonesia that many biodiesel plants are mothballed.

Fit for Industry

R&D

Collaborations

with

Universities

There is significant room to improve yields through improved agronomy,

fertilizer usage and improved plant varieties in Indonesia (and that route is

certainly preferable over trying to press more land into production at the

expense of the environment and national biodiversity conservation).

Industrialization

Barriers for

Indonesia

There is considerable controversy surrounding palm oil and environmental

impacts. Key concerns relate to deforestation for expanded plantations and

the resulting loss of wildlife habitat. There is a significant anti palm oil

lobby globally.

Source: JICA Study Team

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1.4 Research Subjects

Each of the industry platform areas is connected to the three institutions involved in the new

academic research platforms for bioresources. To understand these connections, Battelle has

organized an assessment for each institution that examines their specific capabilities, assets,

existing industry connections and needed investments in the bioresources industry platform areas.

The assessment also illustrates key interests, resources, ongoing industry collaborations and

facilities found at the universities.

This assessment includes a review of the publications by faculty. This publications analysis

considered publications from 2008 to 2013 across 23,000 peer-reviewed journals monitored by

Thomson Reuters through its Current Contents Connect service. It is important to note that the

emphasis on publications varies from institution to institution, with BPPT not placing a strong

emphasis on publications, but more on successful project results. So publications should be

viewed as only one indicator of scholarly capacity. From 2008 to 2013/3rd

Quarter, the number

of peer-reviewed publications generated by institution was:

-BPPT: 87 peer reviewed journal articles

-IPB: 270 peer reviewed journal articles

-ITB: 726 peer reviewed journal articles

Much of the intelligence presented in assessing the research institutions is based on field

interviews conducted over the week of August 19th to August 23

rd to further understand, probe and

analyze the areas of focus and emphasis. At that time, considerable amount of presentations

and materials were shared with the project team.

Below is a summary of the alignment of each of the three institutions by specific target

opportunity areas within the three bioresources platform:

Table 1.4.1 Alignment of the Three Istitutions by Specific Target Opportunity Areas within the

Three Bioresources Platform

BPPT IPB ITB

Pharmaceutical Industry Platform

Herbal Medicine

Biopharmaceuticals for Diagnostics, Vaccines and

Antibiotics

Pharmaceutical Raw Materials

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Agriculture and Food Industry Platform

Agricultural Improvement and Diversification

Value Added Food Products

Industrial Bioproducts Platform

Palm Oil Bioproducts

Source: JICA Study Team

1.4.1 Agency for the Assessment and Application of Technology (BPPT)

(1) Overall Assessment

BPPT offers capabilities and assets across all areas of bioresources industry platforms and

specific industry focus areas. While not all of equal depth, it appears that BPPT would be an

active contributor across all of the targeted areas of industrialization identified.

Generally, a key strength of BPPT is its existing facilities and laboratories. These facilities are

currently sufficient to carry out collaborations with industry, though many could use to be

updated.

The main missing infrastructure component at BPPT is collaboration space for working with

bioresources industry.

Currently, BPPT has many industry collaborators and often is involved in government sponsored

projects and consortiums which also involve industry partners. Since it is a more

project-oriented research institution rather than a traditional academic institution, the culture of

BPPT is well-suited to working with industry on defined projects, with firm timelines and specific

deliverables.

(2) Herbal Medicine

Table 1.4.2 BPPT‘s Research Thrust, Core Competencies, Existing Business Linkages and

Investment Needs for Herbal Medicine

Identified Research Thrust Identification of lead compounds from plants,

microbes and endophytes (screening and

ethnobotany) – Herbal Extract Center.

Herbal medicine development for cancer and

degenerative disease applications

Functional chemical extraction and formulation

Design and engineering of manufacturing and

processing equipment.

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Engaged Centers or Programs LAPTIAB -- Center for Technology for Pharmacy

and Medical

Core Competencies Compound identification and characterization

Extraction technologies and standardization

processes

Testing for efficacy

Signature Facilities and Laboratories Analytical laboratories and integrated lab

operations

Animal research facilities

Publications Activities No extensive body of peer-review publications in

herbal medicine since 2008

Existing Business Linkages Major collaboration with KRIBB of Korea in which

350 compounds have already been screened.

Investment Needs

Source: JICA Study Team

(3) Biopharmaceuticals for Diagnostics, Vaccines and Antibiotics

Table 1.4.3 BPPT‘s Research Thrust, Core Competencies, Existing Business Linkages and

Investment Needs for Biopharmaceuticals for Diagnostics, Vaccines and Antibiotics

Identified Research Thrust Development of domestic antibiotic production

Nano-medicine

Generic diagnostic kit and rapid assay test strips for

infectious diseases (Dengue, HIV and Malaria)

Engaged Centers or Programs LAPTIAB -- Center for Technology for Pharmacy

and Medical

Core Competencies Recombinant proteins

Diagnostic kit development

Medical equipment testing and quality assurance

Some nanoscience

Signature Facilities and Laboratories Pilot fermentation scale-up plant with

bioreactors of various sizes -- 20L, 75L, 500L

and 2500L bioreactors (although 20 years old).

Animal research facilities

Publications Activities Two peer reviewed articles in clinical immunology

and infectious disease – one on TB meningitis and

the other on allergen exposure

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Existing Business Linkages None identified

Investment Needs

Source: JICA Study Team

(4) Pharmaceutical Raw Materials

Table 1.4.4 BPPT‘s Research Thrust, Core Competencies, Existing Business Linkages and

Investment Needs for Biopharmaceuticals for Pharmaceutical Raw Materials

Identified Research Thrust Development of domestic production of active

compounds and excipients to reduce imports

(using fermentation and chemical extraction and

purification platforms)

Fermentation platform for beta lactam,

macrolide, Vitamin B12, statin derivatives and

enzymes (protease, xilanase, lipase).

Chemical and purification platform for: pharma

grade NaCl, chitosan, pragellatinized /modified

starch from cassava and corn

Engaged Centers or Programs LAPTIAB -- Center for Technology for Pharmacy

and Medical

Core Competencies Analytical chemistry

Fermentation/scale up

Signature Facilities and Laboratories Pilot plant fermentation for antibiotic

fermentation-based production (beta lactan)

Publications Activities One peer-reviewed article in pharmaceutical sciences

since 2008

Existing Business Linkages None discussed

Investment Needs

Source: JICA Study Team

(5) Agricultural Improvement and Diversification

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Table 1.4.5 BPPT‘s Research Thrust, Core Competencies, Existing Business Linkages and

Investment Needs for Biopharmaceuticals for Agricultural Improvement and Diversification

Identified Research Thrust Aquaculture (grouper and tilapia breeding and

improvement + functional feed + vaccines)

Probiotic poultry feed

Biopesticide development

Soil improvement materials and microbial

inoculants

Biopesticide development (for Cocoa

applications) Sago plant domestication and

seedling production

Biopeat biofertilizer for soil Ph improvement

Cocoa seedling improvement via micrografting

Biopesticide for IPM in Cocoa

Engaged Centers or Programs LAPTIAB -- Biotech Center, Center for Agricultural

Cultivation Technology

Core Competencies Plant improvement

Micropropagation

Biofertilizer and biopesticide

Signature Facilities and Laboratories Good quality growth chambers

Small scale-up greenhouse and outside field plot

Pilot plant for biofertilizer production

Pilot plant for plant micropropagation and

seedlings (2 million)

Publications Activities No peer reviewed publications

Existing Business Linkages PT Perkebunan Nusantara XII, PT Perkebunan

Nusantara VIII for work in cocoa biopesticide

Investment Needs

Source: JICA Study Team

(6) Value Added Food Products

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Table 1.4.6 BPPT‘s Research Thrust, Core Competencies, Existing Business Linkages and

Investment Needs for Biopharmaceuticals for Value Added Food Products

Identified Research Thrust Post harvest processing technologies

Development of sago-based noodles and

production technology to reduce wheat imports

―Bisku Neo‖ ready-to-eat, packaged

immunomodulatory emergency food.

Engaged Centers or Programs LAPTIAB -- Biotech Center, Center for Agricultural

Cultivation Technology

Core Competencies Food science and nutrition

(emerging) Nutrigenomics for functional food

Signature Facilities and Laboratories None identified

Publications Activities No peer reviewed articles identified

Existing Business Linkages CV Putra Sentosa Tulehu (for Sago noodle)

PT. Tiga Pilar Sejahtera Tbk (for

immunomodulatory emergency food)

Investment Needs

Source: JICA Study Team

(7) Palm Oil and Other Bioproducts

Table 1.4.7 BPPT‘s Research Thrust, Core Competencies, Existing Business Linkages and

Investment Needs for Biopharmaceuticals for Palm Oil and Other Bioproducts

Identified Research Thrust Industrial enzyme production and novel enzyme

identification from microbes (clean room

production)

Improvement of oil palm production via genetic

engineering (seeking to lower saturated fatty

acid content and increase yield via chloroplast

transformation)

Biolubricants development

Jatropha for bioenergy

Bioethanol from starch project (in Lampung)

Early detection system development for basal

stem rot in oil palm

Engaged Centers or Programs Center for Bio Industrial Technology

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Core Competencies Enzymes for industrial bioprocessing (pulp and

paper xylase)

Oil palm plant improvement

Signature Facilities and Laboratories

Publications Activities Six peer reviewed journal articles from 2008-2013

addressing topics of oil extraction, biodiesel

production and energy balance of palm oil biodiesel

Existing Business Linkages Mitsubishi Chemical Corporation (MCC) Japan

and PT. Bakrie Brothers. (Palm oil fatty acid

modification)

RITE (Research Institute of Innovative

Technology for The Earth), Japan and

AsiaSEED( Asia Science Education for

Economic Development ), Japan for palm oil

yield enhancement via chloroplast

transformation.

PT Astra Agro Lestri for palm stem rot

Investment Needs

Source: JICA Study Team

1.4.2 Bogor Agricultural University (IPB)

(1) Overall Assessment

Bogor Agricultural University (IPB) is an active research university in bioresources. It

offers a number of outstanding research centers that have a strong track record in industry

collaboration. While not a research leader in pharmaceutical sciences, which is not

surprising given that it has neither a medical school nor a pharmacy school, it still is a national

leader in herbal medicine leveraging its substantial strengths in agricultural and biosciences.

In the platform areas of agriculture and food and industrial bioproducts, IPB brings an

extensive research portfolio, capabilities and facilities that offer significant value for industry

collaborations.

(2) Herbal Medicine

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Table 1.4.8 IPB‘s Research Thrust, Core Competencies, Existing Business Linkages and

Investment Needs for Biopharmaceuticals for Herbal Medicine

Identified Research Thrust Ethnobotany/bioprospecting

Bioactive ingredient characterization/ analytical

chemistry

Extraction and process standardization

Toxicology

Efficacy (in vitro and in vivo animals)

Product development/manufacturing for human and

livestock products.

Engaged Centers or Programs Biopharmaca Research Center (BRC) – a Center of

Excellence in Herbal Medicine with significant scale

including a stand-alone integrated facility and that

engages nearly 60 researchers/staff, including 38

PhDs.

Core Competencies Medical plants

Extraction and process standardization

Product development for human and livestock

health products

Analytical chemistry

Integrated lab operations

Signature Facilities and Laboratories BRC – animal testing

BRC analytical labs

BRC small scale GMP fill and finish

BRC- medicinal garden and herbarium.

Publications Activities 22 publications identified as addressing medicinal

properties of plants.

Existing Business Linkages Extensive industry connections with Indonesian

SMEs involving a wide range of activities from

product evaluation, raw material advice and product

development. Has a number of products that it

produces until company labels for distribution.

Investment Needs High throughput screening

Clinical nutritional and efficacy trials

Metabolomics, metabolomics and biomarker ID

NMR Spectroscopy

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BRC larger facilities for pilot scale and co-space

with industry (extraction, concentration, quality

control also).

Source: JICA Study Team

(3) Agricultural Improvement and Diversification

Table 1.4.9 IPB‘s Research Thrust, Core Competencies, Existing Business Linkages and

Investment Needs for Biopharmaceuticals for Agricultural Improvement and Diversification

Identified Research Thrust Yield improvement

Disease resistance

Adaption to marginal land, land with high

aluminum

Diversification into fruits and vegetables –

includes assisting with new crop introduction

and building relationships between buyers and

farmers

Composting and microbiology for soil

enhancement

Horticulture (papaya, tomatoes, chili peppers,

eggplant, pumpkin, pineapples, onions) – 20

varieties released

Grains (sorghum for wheat replacement, rice,

corn)

Starch (Cassava, Potato)

Livestock (Balinese cattle breeding/line

purification)

Aquaculture (catfish, tilapia, feed/probiotics).

Engaged Centers or Programs Centre for Tropical Horticulture Studies

Core Competencies Germplasm collection and characterization

Marker assisted breeding (for yield, pest and

pathogen resistance)

Breeding for morphology and quality

characteristics

Extension (participatory breeding and release)

and training.

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Signature Facilities and Laboratories Germplasm repository

Research farm and greenhouses

Small scale seed production and packaging

CTS has two field stations

Publications Activities 33 publications in plant sciences

22 publications in agronomy

13 publications in aquatic/fishery sciences

Existing Business Linkages PT BISI International Tbk (Hybrid Seeds)

Rice Farmers Association

Investment Needs Poor growth chamber/culture facilities

Aging lab equipment and poor quality labs

currently

Scaling seed production (foundation seed) and

distribution (10 ha needed with 1 ha of

greenhouse space) + redundant power system

Post-harvest, cold storage facilities

Isolation greenhouse facilities where can

introduce pests

Need more land for field research

Need an entomology facility

Source: JICA Study Team

(4) Value Added Food Products

Table 1.4.10 IPB‘s Research Thrust, Core Competencies, Existing Business Linkages and

Investment Needs for Biopharmaceuticals for Value Added Food Products

Identified Research Thrust Analog rice (offers a platform for functional

foods)

Food diversification, such as cassava flour,

sweet potato flakes, soy products

Process development for better safety and

quality of food

Palm Oil Processing

Engaged Centers or Programs Southeast Asian Food and Agricultural Science and

Technology (SEAFAST) Center involving 50-100

personnel (circa 49 engaged PhD‘s)

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Core Competencies New food product development

Sensory Evaluation of Foods

Thermal processing of Foods

Product testing/analysis

Process inspections & validation

Post-harvest and cold-chain development

Packaging & labeling

Signature Facilities and Laboratories Packaging center

ISO Lab for functional food evaluation

Food production pilot plant

Extruder for analog rice production

SEAFAST: food quality and

safety/microbiology and chemistry; food

biotech lab; bacterial fermentation lab, animal

assay lab, sensory evaluation center, fats and oils

pilot plant and food pilot plant)

SEAFAST GMP production and packaging

SEAFAST Incubator facility with a few tenants

SEAFAST distance education facility and food

production/safety training – extension type

work.

Publications Activities 16 publications in food sciences and nutrition

Existing Business Linkages BASF – analog rice with anti-cancer

functionality

SEAFAST working with: PT Sari

Husada/DANONE; PT Makin; PT Otsuka; PT

Indofood Sukses Makmur, PT Coca Cola

Indonesia, an PT Ajinimoto.

Investment Needs Larger scale facilities for business incubation

Food marketing and project financing

SEAFAST noted need for better analytical

equipment and larger pilot scale facilities

Source: JICA Study Team

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(5) Palm Oil and Other Bioproducts

Table 1.4.11 IPB‘s Research Thrust, Core Competencies, Existing Business Linkages and

Investment Needs for Biopharmaceuticals for Palm Oil and Other Bioproducts

Identified Research Thrust Selection of palm oil varieties for enhanced fatty

acid expression (C16 and C12)

Palm oil surfactants and cleaning chemicals and

bio-jetfuel from palm oil

Jatropha for biofuel

Micro and macro algae for biofuels

Initial lingo-cellulosic and crop residue biofuel

research

Engaged Centers or Programs Surfactants and Bioenergy Research Center

(SBRC)

SEAFAST

Core Competencies Breeding and cultivation techniques for various

biofuels crops

Research on bioenergy processing and

technology

Signature Facilities and Laboratories SBRC labs and pilot plant

SEAFAST fats and oils pilot plant

Publications Activities Not a strong presence in publications

Existing Business Linkages Cargill plantation JV (oil palm breeding stock)

Oil company sponsors of surfactant research

Korean company and SBRC on algae

Investment Needs Self-sufficient through significant industry support

Source: JICA Study Team

1.4.3 Bandung Institute of Technology (ITB)

(1) Overall Assessment

Bandung Institute of Technology (ITB) is a leading research university in Indonesia. Its

activities in bioresources are found primarily in pharmaceutical industry platform and

industrial bioproducts, though there are activities focused on plant improvement and food

sciences. Still, this is an emerging area of strength, particularly compared to the very strong

applied physics and material sciences strength found at ITB.

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The industry interactions in bioresources are also emerging, with noted activities in industrial

bioproducts. School of Pharmacy also brings close connections to industry applications and

developments.

In addition to faculty enhancement, there is a strong need for modernized and more fully

equipped bioresources laboratories at ITB. While known for having some of the most

sophisticated equipment among Indonesia‘s universities, there is a noticeable lack of

integrated lab facilities and scale up facilities at ITB in the bioresources.

(2) Herbal Medicine

Table 1.4.12 ITB‘s Research Thrust, Core Competencies, Existing Business Linkages and

Investment Needs for Biopharmaceuticals for Herbal Medicine

Identified Research Thrust Among plant species working with includes:

Rutaceae, Liliaceae, Myrtaceae, Piperceae,

Zingiberaceae, and Combretaceae.

Wide range of medical conditions studied,

including anti-neurodegenerative, anti -diabetes,

anti-hypertension, antioxidant,

anti-hyperlipidemia, anti-inflammation,

cosmetics: hair growth stimulants, anti aging.

Engaged Centers or Programs Life Sciences Center

School of Pharmacy

Core Competencies Extraction

Toxicology & Efficacy Testing

Chemical synthesis (medicinal chemistry)

Signature Facilities and Laboratories Drug Toxicity and Safety -- Animal Testing

Publications Activities Less than 5 publications across plant sciences,

chemistry and biology on herbal medicines

Existing Business Linkages None identified

Investment Needs Lacking integrated lab

Source: JICA Study Team

(3) Biopharmaceuticals for Diagnostics, Vaccines and Antibiotics

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Table 1.4.13 ITB‘s Research Thrust, Core Competencies, Existing Business Linkages and

Investment Needs for Biopharmaceuticals for Biopharmaceuticals for Diagnostics, Vaccines and

Antibiotics

Identified Research Thrust Vaccine Development, including:

- Tuberculosis

- Hepatitis B

Development of reagents for diagnostics

Engaged Centers or Programs School of Life Sciences and Technology

School of Pharmacy

Life Sciences Center

Core Competencies Genetics and molecular biology

Pharmacochemistry

Biomedical engineering capabilities for sensors,

robotics and micro-electronic research in School

of Electrical Engineering and Informatics

Bioinformatics capabilities in School of

Electrical Engineering and Informatics and

School of Mathematics and Natural Sciences

Signature Facilities and Laboratories NMR facility

Mass Spectroscopy

Publications Activities 5 publications in immunology and 14

publications in clinical immunology addressing

infectious diseases and vaccines

Existing Business Linkages Working in Ministry of Health Consortiums

involving PT Bio Pharma

Investment Needs Lacking integrated lab and bioprocessing scale up

facility

Source: JICA Study Team

(4) Pharmaceutical Raw Materials

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Table 1.4.14 ITB‘s Research Thrust, Core Competencies, Existing Business Linkages and

Investment Needs for Biopharmaceuticals for Biopharmaceuticals for Pharmaceutical Raw

Materials

Identified Research Thrust Designing and synthesizing porphyrin and

chlorophyll -compound to treat cancer and

chemical study of existing cancer medicines.

Designing and synthesizing quinine derivate

compound as anti-malaria and stereo selective

reagent.

Production of excipient (starches, cellulose,

jelly, alginate, carageenan, dyes).

Advancing new drug delivery systems

Engaged Centers or Programs School of Pharmacy

Core Competencies Analytical Pharmacy

Medicinal Chemistry

Bioequivalence testing

Pharmaceutical biology

Pharmaceutics

Signature Facilities and Laboratories Animal testing facilities

Publications Activities 5 publications in pharmacology & toxicology

Existing Business Linkages n.a.

Investment Needs Lacking scale up facility to enhance

synthesis/production

Source: JICA Study Team

(5) Agricultural Improvement and Diversification

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Table 1.4.15 ITB‘s Research Thrust, Core Competencies, Existing Business Linkages and

Investment Needs for Biopharmaceuticals for Biopharmaceuticals for Agricultural Improvement

and Diversification

Identified Research Thrust Bio-fertilizer (Life Science Center)

Developing new varieties

Adapting plants to environmental stresses

Engineering plant cultivation

Improving plant growth, quantity and

reproduction

In vitro plant propagation of vetiveria

zizanioides and evaluation of oil synthesis on

root

Optimization for scale up production of vetiver

oil

Engaged Centers or Programs School of Life Sciences and Technology

Core Competencies Plant Sciences and Biotechnology

Signature Facilities and Laboratories n.a.

Publications Activities Less than 5 publications in plant sciences

Existing Business Linkages n.a.

Source: JICA Study Team

(6) Palm Oil and Other Bioproducts

Table 1.4.16 ITB‘s Research Thrust, Core Competencies, Existing Business Linkages and

Investment Needs for Palm Oil and Other Bioproducts

Identified Research Thrust Biodiversity of micro and macro alga

Thermal and catalytic conversion

Microbial biotechnology for bio-based

industrial enzymes

Lignocellulosic biofuels from crop/palm

residues

Ethanol from cassava

Bioethanol from lignocellulosic biomass

Xylitol production from lignocellulosic biomass

Green diesel

Biohydrocarbon (bio-gas)

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In vitro plant propagation of Vetiveria

zizanioides and evaluation of oil synthesis on

root (in vitro plantlet).

Environmental health (toxicology of human

exposure to pollutants)

Water quality and treatment

Engaged Centers or Programs Biorefining Research and Innovation Center

Life Sciences Center

Environmental Engineering Study Program

Core Competencies Chemical engineering

Agrotechnology and bioproduct technology

Microbial biotechnology

Plant sciences and biotechnology

Ecology

Environmental Engineering

Signature Facilities and Laboratories Industrial bioenzymes development involving

collection of microbial organisms and integrated

lab using NMR, Mass Spec, X-ray

crystallography

Algae development including culture collection

of macro and micro algae and photobioreactors

for algae production

Integrated bioethanol lab involving

pre-treatment, analytical lab (HPLC) and

lab-scale bioreactor

Catalyst development, characterization, and

testing for green diesel and biohydrocarbons

Currently developing a 3000ltr photobioreactor

for algae.

Publications Activities 16 publications in chemical engineering with

strong focus on production of enzymes and

biodiesel

12 publications in biotechnology and applied

microbiology with focus on biofuels and

bioproducts

17 publications in environmental engineering

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15 publications in ecology

Existing Business Linkages Bio-based enzymes – many industrial

collaborations across paper recycling,

cosmetics, bio-fertilizers

Environmental engineering active in

consultation to industry

Investment Needs Lack of organic chemical synthesis labs – both

lab space and equipment

No gene sequencing capabilities – send out to

Korea for analysis

Need scale-up and piloting facilities for biofuels.

Want to develop an integrated biorefinery

system that would allow for first extraction of

functional phytochemicals and then rest used for

fuels and oils.

Source: JICA Study Team

1.5 Operation and Management Models for R&D: Best Practices to Inform NARC

Activities

The operations and management of the NARC needs to incorporate best practices for leveraging

university research to advance industrialization. The identification of bioresources industry

platforms that align opportunity areas for industry development in Indonesia with university

capabilities is just a starting point. In order to realize the industrialization potential of these

bioresources platforms, there must be mechanisms in place to advance collaboration at the

research and development stage.

An important challenge is the need for efficient access to the research capabilities of the

university and for collaborators to recognize complementary activities. Currently, in many cases

professors are conducting their work in independent labs that are often not well linked to the work

of other labs. Building a critical mass of complementary research activities still appears to be a

challenge. Further advancing a recent trend in some Indonesian research institutes toward

establishing research centers of excellence within a subject area would significantly facilitate the

visibility of research by professors as well as provide for efficient paths to innovation partnerships.

The Biopharmaca Research Center at IPB may be one such model example.

In the case of the Biopharmaca Research Center, partnership with industry is a core element of the

operating model. This model may be expanded and facilitate by research parks around this

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university and the other NARC institutions.

One leading U.S. university known for its ability to connect with industry on research and

development is Georgia Tech. Dr. Steven Cross, Executive Vice President for Research at

Georgia Tech, explains that university‘s approach in advancing an ―industry facing research

strategy‖:

Georgia Tech defined an industry facing research strategy focused both on leading edge,

use-inspired research and economic development. While most universities pursue a linear,

sequential flow of discovery-based research followed by occasional declaration of

intellectual property and subsequent licensing or company formation/spin-out; Georgia

Tech pursues a concurrent strategy centered on the core research areas … [with] alignment

to strategic markets within the region, and the existence of industry partners interested in

working with the Institute…. Concurrency means that teams of faculty, graduate students,

application and economic development experts, and professional staff work together to

define and pursue grand challenges, foster early engagement with industry, and accelerate

the maturation and transition of technology to the marketplace11.

This need for university-industry collaborations in research and development are particularly

important in the bioresource field given its close connections between university research and

industry product development. An OECD study entitled The Bioeconomy to 2030: Designing a

Policy Agenda notes that ―the advantages of collaboration are greater network involvement in

problem solving and testing, a reduction in transaction costs to acquire new knowledge, and a

reduction in licensing costs when firms can access knowledge produced by the collaborative

network at low or no cost.‖ 12

To address the mechanisms for advancing industry-university collaborations, it is best to consider

a continuum of engagement actions between industry and universities to advance bioresources

development in three stages:

-Stage 1: Awareness and relationship building,

-Stage 2: Technology problem solving and new technology development,

-Stage 3: Strategic partnering to address a broad transformative initiative.

1.5.1 Stage 1: Awareness and Relationship Building Among and Between Industry and

11 Steven Cross, ―Strategic Considerations in Leading an Innovation Ecosystem,‖ Journal on Business Review, 2013, vol. 2, no. 3,

104-109. 12 IBID, page 171.

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Academia

Raising awareness and building relationships is a foundational building block for establishing

stronger collaborations between industry and academia. All too often, organizational silos exist

that limit how industry and academia understand the opportunities for engagement and

collaboration with one another. A wide range of activities are available for advancing improved

awareness and relationship building that can serve each of the bioresources platforms areas

including:

-Hold symposiums and regular workshops on key topics of interest that profile

industry identified market needs and share research and development activities

across industry and universities.

Among best practices in this regard is the North Carolina Biotechnology Center‘s (NCBC)

support for Intellectual Exchange groups. The exchange groups are organized by NCBC to create

a ―dynamic research and information-sharing environment‖ and have been organized by special

interest areas, which currently include bioprocessing and process development, plant molecular

biology, virology, immunology, chromatin and RNA. In total, Intellectual Exchange groups have

approximately 40 meetings per year, with thousands of attendees. The NCBC also supports in

collaboration with the Center for Entrepreneurial Development, a bi-monthly Biotech Forum to

provide a meeting place for entrepreneurs, executives, professionals and academicians actively

involved in the biotechnology industry. Each forum consists of a 75 minute panel followed by a

networking reception. Plus, NCBC, together with CED, holds an annual life sciences conference.

Another example on a national level is found in Russia with its National Contact Point on

―Biotechnology, Agriculture, Forestry, Fisheries & Aquaculture and Food,‖ which since 2003 has

been active in promoting Russian science integration into European Research Area (ERA). It

carries out providing information exchange between researches, representatives of SMEs and

multipliers for promotion and development of R&TD co-operation in the Russian Federation and

EC countries. Through its coordination and organization of meetings, workshops, and seminars as

well as facilitating relationship building, the Bio-NCP of Russia has initiated and played the key

role in the establishment of Russian National Technology Platforms in industrial biotechnology,

plants for the future, food for life, forestry, animal health and fisheries and aquaculture.

-Develop “site miners” at each university and for larger companies to help in

matchmaking around specific needs and requests for information. Site miners can

serve as a cornerstone approach for translating collaboration within a varied,

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multi-organizational context. One specific activity would be to support the

development and follow up of symposiums and regular workshops, but the power of

site miners goes well beyond just identifying key staff capabilities and supporting

matchmaking.

A successful collaborative initiative that has broadly embraced the use of site miners is the Center

for Integration of Medicine & Innovative Technology (CIMIT), a clinically-based consortium of

Boston-area hospitals and engineering schools that supports translational research by

multidisciplinary teams for medical device and clinical technology applications. CIMIT involves

physicians from Harvard teaching hospitals who collaborate with scientists and engineers from

MIT, Charles Stark Draper Labs, Northeastern University and Boston University, as well as a

wide range of industry partners. CIMIT demonstrates that it is possible to systematically facilitate

the process of addressing real market opportunities through innovative technology solutions.

According to CIMIT in its detailed explanation of its business model13, the most unusual,

inventive and productive of CIMIT‘s facilitation roles is the use of site miners. These individuals

have proven to be the key to penetrating the multiple isolated member institutions, and connecting

people and ideas across the cultural walls of these institutions and even across the boundaries

separating departments within them. They literally ―mine‖ the institutions for projects and people

deserving CIMIT‘s attention and help. The core reason for the effectiveness of this site miner role

is perhaps not obvious. Involvement via a site miner avoids activating the natural institutional

antibodies of an institution to the ―invasion‖ of an external entity. Co-investment in the role

creates a sense of shared ownership of success by the institution (and its CEO) together with

CIMIT. Site miners provide far greater visibility for the value of CIMIT within each member

institution. In addition, site miners serve as role models for interdisciplinary careers, and can

advocate effectively within their own institutions for the career advancement (academic

promotion) of interdisciplinary faculty who would otherwise fall into the cracks between

departments and promotion committees.

It is also important to provide information tools for industry to be able to quickly learn about

research activities underway and capabilities and interests of researchers at academic institutions.

Harvard has created profiles for this purpose and many other universities are mirroring this effort.

Furthermore, academic institutions should be encouraged to publish all trials/studies underway in

a way that can be easily searched.

-Offer sabbaticals and stipends for academics to spend time in industry as well as for

industry scientists to spend time in academia. There is no better way to build

13 The CIMIT business model can be reviewed at: http://www.cimit.org/about-cimit-model.html.

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relationships than to create the experience of working together. It allows not only a

sharing of knowledge, but a better appreciation of the culture and specific

requirements found between the worlds of academia and industry.

Visiting scientists programs are not at all unusual within academia. They are often used by

specialized research centers to provide broader exposure to unique methods and techniques to the

research community as well as to establish broader collaborations. It is less typical to have

industry scientists spend time in academia. It is particularly important for industry scientists to

gain exposure to research leaders and to the technology transfer processes at different universities.

Another approach is the use of visiting scientists from academia to industry. This is particularly

important to do if academia is to learn about the market opportunities and the requirements facing

industry in bringing innovation to the marketplace. Technology transfer staff at universities

should also be part of this effort so that they can get a better understanding of the drivers for

industry product development efforts and industry licensing practices.

-Pursue pro-active university policies to support and encourage collaborations.

University policies can have significant impact on the willingness and interest of

researchers to pursue industry collaborations. Universities should ensure that

promotion and tenure policies provide incentives for researchers to pursue industry

partnerships and intellectual property generation.

Another critical issue is addressing conflicts of interest. Across all technology areas, universities

need to focus on effectively managing conflicts of interest rather than being too restrictive and

seeking simply to eliminate them. It is important for universities to provide straight-forward

processes for disclosing conflicts, counseling and assisting researchers as they seek to address

conflicts, and taking seriously conflict of management committees to oversee the process. In the

life sciences, managing conflict of interest needs to also take into account the more complicated

situations found in clinical innovation involving the physician-patient-subject relationship, which

places increased demands for disclosure and managing potential conflicts.

Finally, it is important for universities to have predictable and streamlined processes in which

industry can take ownership of intellectual property from sponsored research with universities

and for licensing technologies. For instance, the University of Minnesota allows a company

sponsoring research at the university to pre-pay a fee and receive an exclusive worldwide license

at a set royalty rate. Similarly, the University of North Carolina has put in place the Carolina

Express License, which offers a ―standard‖ license agreement for university developed

technology to ease the burden and time requirements on negotiations, involving reimbursement of

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patent expenses and standard royalty fees.

1.5.2 Stage 2: Project-driven, One-on-One Industry-University Applied Research and

Technology Development Mechanisms

For industry-university partnerships to take root, they must be results driven. Information sharing

and relationship building are useful activities, but they fail to drive the bottom line for industry

interest and involvement—generating new products, sales and jobs. In today‘s global knowledge

economy where innovation drives competitive advantage for industry, this means that the

research capabilities and technology advances of academia must be matched to the short-term,

time sensitive and product-driven needs of industry.

Far too often, the academic research capabilities and technology advances are potentially

interesting to industry, but still at too early a stage for industry to invest in further research and

development. This is the much-cited ―valley of death,‖ which results in states and regions failing

to realize their full economic development potential.

There are two discrete targets for bridging the ―valley of death‖—one driven by university basic

research discoveries and the other from industry market needs. First, for advancing university

basic research discoveries, it is critical to assess the potential of that discovery to support a new

start-up venture or new product line for an existing corporation. Here, the innovation gap is proof

of concept funding to validate the discovery‘s commercial benefit. For instance, a new research

discovery of a key drug target may need to have some animal testing completed to address its

efficacy before it can be advanced as a new drug candidate for clinical testing. Second, for

responding to industry driven market needs, bridging the ―valley of death‖ has its starting point in

advancing an application or solution in response to a market need identified by an existing

company. In this case, the innovation gap is adequate funding for applied research to develop an

approach to address the solution needed.

Establish a NARC proof-of-concept fund to advance university-business research

discoveries. Proof-of-concept funding provides the testing and development to demonstrate that a

research discovery has commercial potential and in doing so is integral for establishing the value

of the discovery. Often, proof-of-concept funding mechanisms provide a staged funding approach

to moving promising life science university research towards commercialization.

Among the most well-known proof-of-concept centers are those based at specific universities,

such as Deshpande Center for Technological Innovation at MIT and the Von Liebig Center at

University of California San Diego. Each of these combines proof of concept funding with active

due diligence and business review and strong linkages to entrepreneurial mentoring. To give a

sense of impact, the Deshpande Center since its launch in 2002 has invested $11 million across 90

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projects, which has resulted in 26 start-ups, $350 million in venture capital raised and 400 jobs to

date.

A broader statewide effort is that of the Georgia Research Alliance‘s VentureLab program,

supported through state appropriations. VentureLab is focused on starting up new companies from

university research through identifying promising technologies, conducting due diligence, and

supporting proof-of-concept and venture start-ups. It provides for a rigorous and staged

assessment of commercialization potential through a three phase grant process:

-Up to $50k grant: Is it commercially feasible to support a new company,

-Up to $100k matching grant: Prototype development (matching funds to validate in

marketplace required),

-Up to $250k loan: Executed license + management team in place.

To facilitate the process, GRA supports ―VentureLab‖ managers at each participating campus,

who focus on recruiting and overseeing the efforts of serial entrepreneurs to move the VentureLab

process forward.

The results of GRA‘s VentureLab program have been outstanding. $19 million of state funds

deployed since 2002 resulting in the formation of 108 active companies, $460 million of

additional funds attracted and over 500 jobs created.

Another interesting way to enable proof of concept efforts to move forward is how Brazil enables

university researchers to dedicate themselves to advancing innovations with commercial potential.

Under Brazil‘s 2004 Innovation Law, university researchers may take leaves of absence of up to 3

years to create a start-up company, while maintaining their benefits and career rights.

Offer a matching grant program for industry/university applied research projects. A proven

means of fostering greater industry-university collaborations in applied research to address

market needs of companies is a matching grant program. Such programs help build relationships

between academic researchers and companies and provide support for activities that may lead to

investments of private capital and commercialization of new technologies.

One example is the efforts underway in South Africa. South Africa supports several

complementary programs designed to encourage innovation in private industry, crossing several

sectors including but not limited to biopharmaceuticals. Among these are the Technology and

Human Resources for Industry Program (THRIP) 14, which provides a 50 percent funding

match to foster collaboration between industry and higher-education institutions, with the

additional goal of facilitating the movement of research personnel between industry and academia.

14 See http://thrip.nrf.ac.za/

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The program supports on average 2,400 students per year15.

An excellent example of a focused effort in spurring major industry-university collaborations in

applied research is the Science Foundation of Arizona – which was modeled after Science

Foundation Ireland. Founded in 2006, Science Foundation Arizona (SFAz) is a unique 501(c)3,

public/private, non-profit organization created from the collaboration of three Arizona CEO

business organizations—Greater Phoenix Leadership, Southern Arizona Leadership Council, and

Flagstaff 40 (including the City of Flagstaff)—along with the Legislature and Executive Branch

of the State government.

SFAz‘s purpose is to diversify and strengthen Arizona‘s economy by:

-Establishing significant industry and university R&D partnerships,

-Attracting and retaining world-class talent and jobs,

-Creating a competitive advantage through science and innovation,

-Enabling Arizona to compete effectively in a Global Economy, and

-Increasing access to quality science, technology, engineering and mathematics (―STEM‖)

education to grow a pipeline of future talent.

SFAz funds performance-based, competitive grant programs. It offers an applied research grant

program with industry, known as the Strategic Research Group (SRG) grants. These grants seed

strategic collaborations between Arizona‘s non-profit research-performing institutions and

industry partners in order to create economic advantages for the state, with the intent of anchoring

industry R&D, creating commercial products, and increasing the probability of attracting major

federal research funding and large group grants. These grants require a 50/50 match from the

industry partners.

From 2007 to 2010, SFAz funded 29 Strategic Research Group grants, for a total of $48.5 million.

In return, SRG grants are already making significant contributions, including:

-Leveraging an additional $86.9 million in funding, thereby leveraging state funds by

nearly two to one

-Generating 374 scientific publications

-38 patents either issued or applied for

-Three technology licenses

-Eight new companies created

-861 direct job-years from just the research activities

15 http://www.southafrica.co.za/about-south-africa/science-and-technology/

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What stands out about the SRG grants is the cutting-edge technology they are advancing through

industry-university partnerships. Among the life sciences industry-university partnerships being

advanced are:

-Cancer Diagnostics. Top university researchers in chemical genomics have teamed up with

private sector companies in Tucson to develop a personalized cancer test to identify a

course of treatment with the best chance of success for individual patients.

-Accelerating FDA Drug Approval. Cooperation between pharmaceutical companies and

the Critical Path Institute in Tucson on the establishment of a Center for Federal Drug

Administration and Industry Collaboration (CFIC) to expedite FDA drug approval.

-Valley Fever Diagnostics. Development of newer, faster and more effective diagnostics for

Valley Fever at TGen North in Flagstaff.

-Green Fuel Cells. The long-term future of aviation depends on the ability of planes to use

alternate fuel. For this purpose, Boeing and top university researchers are working to

develop the first biofuel-driven fuel cells to power electrical systems of commercial

airliners.

1.5.3 Stage 3: Strategic Partnering to Address a Broad Transformative Initiative

Beyond the one-on-one, project-driven assistance for proof-of-concept funding and applied

research, there is an increasing focus by states and regions to advance their leadership and

develop an international reputation in the life sciences by tackling a specific area of life sciences

development with the focused goal to build a competitive advantage that positions the region/state

as a global leader in an area of the life sciences with significant economic advancement

opportunities.

Advance transformative initiatives through strategic industry-university partnerships. By

focusing on a specific area of life sciences development that encompasses multiple projects and

multiple organizations, Indonesia can be positioned as a global leader. These transformative

initiatives in specific areas of life sciences development must address the focused goals of:

-Advancing world-class ―basic to translational‖ research and innovation capacity,

-Attracting and generating top talent,

-Focusing on commercialization,

-Fostering the growth of existing firms, creation of new firms, and attraction of firms to

Indonesia, and

-Generating a health care dividend for Indonesia.

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An excellent example of a systematic approach to industry-university partnerships that grows

from pre-competitive research to commercialization is the efforts of Israel‘s Office of Chief

Scientist (OCS). The OCS also operates several ―pre-competitive R&D programs16‖ that are

designed to encourage closer collaborations between industrial and academic researchers across

all scientific disciplines. For example, in the life sciences, the OCS funded the creation of the

National Institute for Biotechnology Research and Development17. Research institutes of this

type are expected to earn at least 30 percent of their revenue from industrial contracts. Under this

same umbrella, the OCS provides 66 percent subsidies, without any repayment requirements, for

university/industry consortia and for specific technology-transfer projects. The OCS then

administers several programs that provide ―pre-seed/seed‖ capital 18 . Relevant to the

biophar-maceutical sector is the $30 million ―technological incubators‖ program 19 .

Technological incubators provide a sheltered environment in which scientists can nurture

innovative ideas while receiving financial support, expert business advice, subsidized office and

lab space, and exposure to potential investors. Since 1990, the OCS has created 24 incubators,

owned by either academic institutions or private investors. At least two incubators are now

dedicated specifically to biotechnology. The OCS routinely funds as many as 10 specific

commercialization-research (pre-seed) projects within each incubator. Each project supports a

principal entrepreneur and several staff for up to 3 years, paying 80 to 85 percent of approved

costs. Projects are funded up to $1.8 million each in the biotechnology sector. Of all projects (all

sectors) funded since 2006, the OCS reports that 57 percent attracted follow-on investment, and

that 41 percent of those no longer receiving direct OCS support are still active in commercial

markets. OCS pre-seed awards are paid back via a 3.5 percent royalty on sales, and ownership in

the start-up is typically shared between the entrepreneur and the incubator. Once a start-up is able

to attract private investment, the OCS can match private investors up to $1 million through its

affiliated Heznek Seed Fund. The private co-investor is given an option to buy out the state

interest at a later date.

Another effort focused on transformative initiatives, with a proven track record, is Ohio‘s Third

Frontier. The Ohio Third Frontier (OTF) was created in 2002 to advance Ohio‘s economic

competitiveness and the generation of high quality jobs. The results to date have been significant.

Through the OTF program, Ohio has generated 79,464 jobs, $6.6 billion in leveraged funding,

and created, attracted, or capitalized 701 companies between 2002 and June 2011. In addition,

these investments have had significant impact on the business environment of the state for

16 See http://www.moital.gov.il/NR/exeres/D8C128E3-63D8-441B-86BE-844011126452.htm. Visited May 5, 2011. 17 See http://www.atp-israel.com/bgu/nibn.html. Visited May 5, 2011. 18 See http://www.moital.gov.il/NR/exeres/562B0C33-6809-4737-81EB-A40E9F0756FA.htm. Visited May 5, 2011. 19 List here: http://www.moital.gov.il/NR/exeres/14424C5D-A102-4C67-B3BE-F1A6C3B2227D.htm. Visited May 5, 2011.

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technology companies, including the deepening of collaborations between and among Ohio‘s

industrial and research base.

A detailed independent assessment of the Ohio Third Frontier by SRI International found:

―Interviews with stakeholders clearly indicated that the Ohio Third Frontier is improving both the

research infrastructure and research collaboration in the state. University centers, such as the

Liquid Crystal Institute at Kent State University, that in the past licensed their technology to

overseas companies, are now collaborating with Ohio companies. Indicators of universities‘

connection to industry, such as industry funding of university research, university licensing

revenues, and the number of university-based startup companies, are all showing positive trends.

Although there remains work to be done to improve these linkages, Ohio Third Frontier has

significantly strengthened linkages among universities, industry, and research laboratories,

especially in the targeted technology areas.‖ 20

The signature initiative of the Ohio Third Frontier for promoting broad-based industry-university

consortiums is the Wright Centers of Innovation Program focused on targeted technology

platforms. From 2003 to 2008, OTF awarded $295 million to Wright Centers of Innovation,

including $147.3 million to life sciences related efforts. Prominent Wright Centers of Innovation

in the life sciences include:

-The Global Cardiovascular Innovation Center (GCIC), a $250 million product

commercialization consortium led by the Cleveland Clinic. Partners include Case Western

Reserve University, The Ohio State University, the University of Cincinnati, the

University of Toledo, University Hospitals, industry leaders, and economic development

organizations. The State of Ohio contributed $60 million to the Center. GCIC provides

commercialization assistance to its member companies, including creation of spin-off

companies and equity partnerships, assistance with licensing and IP issues, technology

validation, links to venture capital funding networks, and access to prototyping and

preclinical facilities. GCIC currently has 12 companies in its portfolio. GCIC has an

Entrepreneurs-in-Residence program and has organized a venture investment consortium

that includes professionals from several prominent venture capital firms who will jointly

evaluate investment opportunities. Talent recruitment services are available through Case

Western Reserve University.

-The Wright Center of Innovation in Biomedical Imaging serves as the focal point of

collaboration between companies and medical researchers in biomedical imaging

20 SRI International, Making an Impact: Assessing the Benefits of Ohio‘s Investment in Technology-based Economic Development

Programs, September 2009.

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throughout the state and has helped to bring and retain jobs in Ohio. In 2001, Philips

Medical Systems—a world leader in medical technology based in the

Netherlands—acquired Marconi Medical which Cleveland‘s Picker X-Ray had evolved to

become through a series of acquisitions. Due to currency exchange rates and external

factors, strong consideration was being given to relocating manufacturing operations to

Europe. As a result of the creation of the Wright Center, Philips decided to keep

development of new imaging devices and manufacturing in Ohio. Additional Ohio Third

Frontier grants have helped to advance the goals of the Wright Center and solidify Philips‘

corporate commitment to Ohio. Today, Philips Medical Systems is headquartered in

Cleveland, representing a major anchor company within Ohio‘s growing biomedical

imaging cluster. Ohio can also lay claim to the development and manufacture of the

world‘s most advanced commercially available MRI. A major goal of this Wright Center

of Innovation in Biomedical Imaging was the development of an Ultra High Field 7.0

Tesla MRI scanner that generates body scan images with extremely high resolution

relative to current technology.

Another far-reaching initiative that fosters broad-based industry-university consortiums is the

Kansas Bioscience Authority (KBA). It was created in 2004 to advance Kansas‘ leadership in the

biosciences, and encompasses an innovative financing structure based on the growth of state

income tax withholdings from employees of bioscience-related companies. State taxes that

exceed the base-year measurement of such taxes accrue to the authority for investment in

additional bioscience growth. This mechanism makes it unnecessary to raise taxes or reallocate

amounts from other state budgets. Revenues that accrue belong exclusively to the Kansas

Bioscience Authority and are not part of the state treasury.

The overall KBA initiative is designed to:

-Build world-class research capacity,

-Foster the formation and growth of bioscience startups,

-Support expansion of the state‘s bioscience clusters, and

-Facilitate industrial expansion and attraction.

According to KBA, the hub of its research capacity investment strategy is the Kansas Bioscience

Center of Innovation program (Centers of Innovation). Through this program, Kansas can address

its dual needs to build world-class bioscience research centers in its research institutions, and to

assist existing and emerging bioscience industries in capturing new knowledge and research

findings for their product and production functions. The Centers of Innovation focus on research

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and development in core technology areas that establish national and international research

excellence and lead to high commercial payoff in new products and processes. The R&D agenda

of these centers focuses on areas of interest to Kansas companies and potential entrepreneurs.

They are designed not only for excellent research, but also for productive commercialization.

Centers operate as consortia of industry, higher education, and other private research

organizations driven by strong industry involvement.

Among the KBA funded Centers of Innovation are:

-The Center for Animal Health Innovation is linking technology developers with industry,

thereby helping to bring new products to market faster and more efficiently. The

geographical concentration of companies within the region‘s Animal Health Corridor, and

Kansas State University‘s leadership role in animal health and animal disease research

made the school‘s new Olathe campus the right location for the new center. The center

brings nine area animal health companies, plus regional universities and government

agencies together to accelerate job creation, research, development and commercialization

of the next generation of animal health and nutrition products.

-The Kansas Alliance for Bioenergy and Biorefining (KABB) is uniting key industry

players such as Archer Daniels Midland with the world-class research and development

efforts at the University of Kansas and Kansas State University. The center of innovation

uses commercial biorefining to develop alternative fuels and chemicals; commercializes

efficient biomass resources for cost-effective quality power; and improves carbon capture.

As with other KBA Centers of Innovation, the focus of this center is commercial viability,

which requires the confluence of economic viability with technical feasibility and

marketplace acceptance.

-Heartland Plant Innovations (HPI) is developing advanced technologies for gene discovery,

trait validation and crop improvement in order to deliver new products and production

platforms. The global research team associated with the center focuses on emerging

commercial opportunities for wheat and sorghum, crops in which Kansas has

world-renowned leadership and expertise. The center is a public and private collaboration

of Kansas Wheat, Kansas State University, the University of Kansas, and many private

investors.

-The Center of Innovation for Biomaterials in Orthopedic Research (CiBOR) is creating

medical instruments, medical devices, and composite implants that will improve the

practice of orthopedic medicine. The center focuses on commercial viability, conducting

research requested by industry to meet market needs, and capitalizing on the concentration

of composites expertise found in Wichita due to the state‘s longstanding aviation industry

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leadership. Together with the KBA, CiBOR is jointly sponsored by Via Christi, one of the

largest health systems in the Midwestern U.S., and Wichita State University, home of the

National Institute of Aviation Research.

1.6 Commercialization Models: Best Practices to Inform NARC Activities

Research by itself will not translate into technology being transferred, commercialized and

developed into a new product by the public or private sector without having a support

infrastructure in place to help move it through these various development stages.

Several important commercialization steps are needed for the industrialization activities to be

successful.

-Technology transfer is not sufficient to drive commercialization

-Incubation is a critical component

-Need for incentives

-Pro-active outreach marketing is critical

1.6.1 Importance of Going Beyond Technology Transfer with Complementary Technology

Commercialization Activities

Technology transfer is the passive management of a research organization‘s intellectual property.

Technology transfer involves disclosure of discoveries, the determination of the need for patent

protection, and the licensing of the intellectual property (to either a third-party organization or to

create a new business) to pursue the development of a product, process, or other intervention

based on the discovery, and its associated license.

Quality technology transfer approaches are critical, but not sufficient to advance

commercialization of technologies. Complementing, but distinct from technology transfer, are

more pro-active efforts to commercialize technologies, focused on enhancing technology

solutions to meet the need(s) of customers in the marketplace. Technology commercialization is

primarily concerned with building and growing new products and processes in existing or new

firms. It involves a number of activities, such as assessing the technology and its potential

markets against current products in the marketplace (e.g., technology and market assessments). It

involves developing the product itself, and optimizing its engineering and design to meet price

points of the marketplace, if sales and growth are to occur. It involves putting the business and

management team in place and securing the sources of equity and working capital that will carry

the product and/or firm through various stages of maturity until it becomes an established

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company/product in larger domestic and global markets.

Often Technology Transfer Offices at research universities, have difficulty, in going beyond the

more passive efforts to protect and license technologies and engaging in the commercialization of

technologies.

Table 1.6.1 Technology Transfer vs. Technology Commercialization – Stages

Technology Transfer Technology Commercialization

Technology

Development

Stage

Discovery Translational

Research

Technology

Development

Product Development Production/Marketing

Outcome Invention

Disclosure

Publication

Proof of Concept

Patent/Trade

Secret

License

Engineering

Optimization

Product Prototype

Pre-seed business

Initial Product

Start-up business or

new program (for

established companies)

Mass Production

Established company

Source: Adapted from NIST, ―ATP and Venture Capital Funding Criteria Differ,‖

http://www.atp.nist.gov/factsheets/1-c-9.htm

The recently released 2012 survey of North American university research parks prepared by

Battelle for the Association of University Research Parks brings up-to-date the state of university

research park activities considering a wide range of key topics about how university research

parks operate and what matters in driving success. This is summarized in Table 7.5.2.

One key finding of this updated research park benchmarking study is that commercialization

services are critical. Across individual business and commercialization services, the most

common services offered include helping industry tenants access state and local programs for

business and commercialization and linking to or directly providing sources of capital.

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Table 1.6.2 Business and Commercialization Services Offered

Service Offerings Percentage of

Total Parks

Help access state and other public programs 81%

Link to or provide sources of capital 72%

Assist with business planning 64%

Advise on marketing and sales strategy 61%

Provide access to subsidized space 57%

Perform technology and market assessments 56%

Assist with human resource issues 44%

Provide proof-of-concept funding 36%

Source: The 2012 Survey of North American University Research Parks: Driving Regional

Innovation and Growth

1.6.2 Incubation Services are Critical

As a result of their targeted focus on building innovation ecosystems and on providing the

services that such systems require, university research parks have a demonstrated record of

economic development success that stem from their innovation activities, particularly through the

incubation of emerging technology companies. This success not only fuels the growth of research

parks, but has positive spill-over effects for the regions served as these emerging technology

companies graduate from the university research park and, frequently, set up shop in the

surrounding community.

Park directors from the 108 responding university research parks reported that 963 businesses

have graduated from their incubators or related startup space in the last five years. Of these

graduate startup companies 26 percent remained in the park (with 24 percent having moved to

multi-tenant space and 2 percent having moved into their own buildings). An additional 43

percent of graduate startup companies left the park but remained in the region (with 30 percent

locating in close proximity to the park). Just 12 percent of the graduate startup companies left the

region. Significantly, only 19 percent of the graduate startup companies were no longer in

business, considerably outperforming overall national statistics on startup companies, where over

50 percent fail within five years21. Apart from the extraordinarily high success rate of startups that

are incubated in a university research park, it is also important to note that of those startups that

succeed, a full 77 percent remain in the region surrounding the park where they were incubated,

21 Scott Shane, ―Start Up Survival Rates: The Definitive Numbers,‖ Small Business Trends, December 17, 2012, see

http://smallbiztrends.com/2012/12/start-up-failure-rates-the-definitive-numbers.html

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further contributing to the region‘s attractiveness as a center of innovation.

Table 1.6.3 Startup Companies Incubated Through University Research Parks

Status of Startup After Graduation from Incubator Percentage of Total

Moved to multi-tenant space within park 24%

Moved to own building in park 2%

Left the park but remained in the region 43%

Left the region 12%

No longer in business 19%

Other 1%

TOTAL 100%

Source: The 2012 Survey of North American University Research Parks: Driving Regional

Innovation and Growth

1.6.3 Incentives for Start-ups and SME Strategy

The ability to succeed in positioning NARC for success in commercialization depends upon

having the right mix of incentives to stimulate existing and emerging companies in conducting

product development as well as to attract critical venture funding for emerging companies.

One well-established incentive is to offset the cost of company research and development

activities.

1.6.4 Proactive Marketing and Outreach

Technology commercialization needs a proactive marketing and outreach effort to be successful.

All too often excellent programs are developed, but not marketed and so fail to find an audience.

This proactive marketing and outreach needs to target both domestic and international businesses,

as well as both well-established and emerging companies. This activity should be approached as

an integral part of the larger business and entrepreneurial outreach activities for BPPT, IPB and

ITB. By design and positioning, the NARC should serve as an accessible portal and point of entry

for members of the outside business community seeking to engage in commercialization and

related partnering activities.

Key elements for NARC‘s proactive marketing and outreach should include the following

interrelated activities:

Identity Branding and Awareness Building

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This effort involves creating logos, slogans, signage, collateral materials, periodic electronic

communications, and architectural and land use renderings to be used in all elements of the

outreach campaign for purposes of raising awareness and visibility of NARC for both external

and university audiences. Communication channels will include: website,

brochures/collaterals, social networking, conferences, newsletters, tradeshows, media relations,

international trade missions, all with consistent messaging and branding. Once established, there

should be an ongoing effort to continuously reinforce this identity branding, with regular updates.

Participation in Trade Shows and International Recruitment Missions

An annual calendar of domestic and international trade shows and missions will be scheduled and

attended.

Targeted Events Marketing

Sponsoring, hosting and promoting networking, association events and conferences with

university linkages will be key to developing relationships that lead to demand for NARC‘s

facilities. Experience has shown that well targeted events that bring together potential

collaborators can lead to projects and potential tenancies. Thus, while the NARC will not

organize all conferences and events that occur, it should be positioned to support, promote and

occasional sponsor events that lead to partnering that occur at its university and national labs sites.

Toward this end, a shared calendar of events should be developed and maintained for both

planning and promotion purposes. Examples of the types of networking events that could be

promoted include:

-Entrepreneur‘s Day, which should be scheduled as run as an annual event with sponsored

support.

-Periodic ―brown bag‖ lunches and briefings sponsored for targeted industry executives.

-Periodic events with affiliated Indonesian business associations.

-Various business plan and technology competitions and venture forums involving faculty,

graduate students and entrepreneurs.

Development of a Contact and Relationship Management System

Well prior to the completion of construction for NARC facilities, a system for managing targeted

outreach, tracking of contacts and prospects and appropriate follow-up should be established.

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Chapter 2. Information Gathering and Analysis of Existing, Preceding

and Similar Clusters

When planning NARC in Indonesia, it is necessary to look down at the bio-cluster of the foreign

country, and in order to use as reference of the Indonesia NARC, information on planning,

construction, search for tenants, operation management, policy assistance of the government, etc.,

were collected.

2.1 Examples of Clusters in Japan, Asia, Europe, and USA

Although there are many bio-clusters in the world, especially in this report, the report focuses on

the biocluster of Asian countries which competes with NARC project, and the team conducts

collection and analysis of this information. Biotech industry is attracting attention as a new

growth field in recent years, and not only in developed countries but Asian countries show the

motion raised positively in 2000 and afterwards. The analysis for obtaining the hint which

contributes to establishment of Indonesia NARC, and to operation management, etc. from these

findings was conducted.

Looking at the bio-clusters in Asian countries, it is clear that the government of each country has

strongly performed legal and incentive provisions, strengthening of personnel training, etc. in

order to develop the bio industry of in the countries. Conclusively, if the development of bio

industry is aimed at also in Indonesia, leadership, powerful government policies and measures

such as laws and ordinances provisions are essential.

2.1.1 Examples of Clusters in Asia

(1) Overview of Asian Bioclusters

In considering bioclusters in Indonesia of an Asian, it is indispensable Indonesia Bioclusters must

compare with neighboring Asian countries clusters. In Asian countries, Japan has the biggest

number of bioclusters (25 districts) and this means regional development using Bio industry. In

Korea, the bio-related import (31.3%) is substituted to domestic products (68.7%), and it

contributes to stimulation of domestic demand by bio industry field. Taiwan interlocks the newest

and biggest hospital and clinical test laboratories, in Hsinchu bio-medicine park, and is expanding

bio research to the life science field. Singapore invited the globally prominent researcher, invited

the global drug industry, and it means that the country has imported the whole researcher with

investigational seeds from overseas. In other Asian countries, the results of bioclusters have not

been seen tangible yet.

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The bio-clusters of Taiwan, South Korea, Singapore, and Malaysia in Asian countries are

individually described below and it is considered as reference of Indonesia bio-cluster.

The biocluster of Indonesia from the lesson and learnt by Asian countries is considered as

follows:

1) Inviting investigational seeds and researchers from overseas by collaborative research,

and making the many seeds of industrialization

2) Proceeding applications of biotechnology with little energy consumption and

less-pollution to the industrial field

3) Developing economical medical supplies applying biotechnology for a big population

The present conditions of the policy and biocluster of Singapore, South Korea, Taiwan, India and

Malaysia among Asian countries is described below.

(2) Singapore

1) Purpose and Background for Cluster Location

Science and Technology in Singapore have shown a top-down approach. The sector‘s

policies are formulated by the Ministry of Trade and Industry, with EDB, A*STAR and

SPRING being the statutory implementation bodies. This has ensured integration of the

sector‘s policies with the State‘s overall economic development strategy. Alongside,

flexibility to change is also incorporated.

Source: OECD, ―Innovations in Southeast Asia‖ 2013

Figure 2.1.1 Institutional Framework for R&D in Singapore

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Source: UN ECLAC, ―The Singapore success story: public-private alliance for investment

attraction, innovation and export developments‖ 2010

Figure 2.1.2 Functional Network between Policy, Program and Real Estate in R&D Sector

a) History of Biotechnology in Singapore

In the 1980s, there was significant thrust in Singapore‘s industrial policy towards

value-addition and ―brain-intensive‖ sectors. (Tan, 1983) The Economic

Development Board (EDB) established the National Biotechnology Programme

(NBP) to promote the fast-growing industry as well as a National Biotechnology

Committee (NBC), among whose recommendations was the creation of a Training in

Biotechnology Scheme (TIBS) to promote and speed up the transfer of knowledge,

technology, and skills in biotechnology.

The focus in the 1990‘s was heavy on developing technologies critical for

Singapore‘s industrial clusters. In 1999 a new economic development program called

Technopreneurship21 was launched. In 2001 focus shifted to basic research, to create

long term robust innovative capacity. (OECD, 2013) Singapore‘s success in

biotechnology is most visible in Biopolis, launched in 2003 as an integrated cluster of

research facilities in an urban setting. With the allocation of SGD 1.55 billion in 2011,

future growth is being focused on three strategic sectors – Biomedical Sciences

(BMS), Environmental and Water Technologies (EWT), and Interactive and Digital

Media (IDM).

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Table 2.1.1 Major Landmarks in the History of Biotechnology in Singapore

Year Main Issues

1983 Thrust in Industrial Policy towards value-addition and

―brain-intensive‖ sectors

1989 EDB established the National Biotechnology Program

1990‘s Focus only on industrial technology

2001 Focus shifted back to basic research

2003 Launch of Biopolis

2006 Research, Innovation and Enterprise Council (RIEC)

established

2011 Allocation of SGD 1.55billion to the National Research

Foundation

Source: JICA Study Team

Source: A*STAR, ―National Survey of R&D (2002 - 2011)‖

Figure 2.1.3 R&D Expenditure in Biomedical Industry

b) Governmental Commitment to Promote Biotechnology

(i) Investment

In response to government policy, the Singapore economy is becoming more

R&D intensive. Singapore ranks second globally in competitiveness (World

Economic Forum, 2013). Its public and private institutions are rated as the best in

the world for the fifth year in a row. With the Research, Innovation, and Enterprise

0

200

400

600

800

1000

1200

1400

1600

2002 2003 2004 2005 2006 2007 2008 2009 2010 2011

R&

Dexp

en

dit

ute

in

Bio

med

in

du

stry

(S$

Mil

lion

) Experimental

development

Applied

Basic

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2015 plan, the government is committed to investing $16.1 billion between 2011

and 2016 to bolster Singapore‘s Research and Development (R&D) sector. In less

than 2 decades, Singapore‘s R&D expenditure has increased tenfold, from S$760

million in 1991 to S$7.4 billion in 2011. Of this, about two-thirds of R&D

expenditure was from the private sector. Expenditure in biomedical and related

sciences showed an increasing trend, in line with overall growth in R&D

expenditure up to 2008. During the global depression starting 2009, overall R&D

expenditure and biomedical expenditure took a down turn, while public

expenditure rose significantly. Flexible and well-timed State policy in support of

private sector expenditure has helped keep the R&D scene flourishing.

Source: A*STAR, ―National Survey of R&D(2002 - 2011)‖

Figure 2.1.4 Gross Expenditure on R&D and Biomedical Sciences, and Public Expenditure on

Biomedical Sciences

(ii) Education

Singapore also has world-class infrastructure (2nd) and a strong focus on

education, providing individuals with the skills needed for a rapidly changing

global economy. It ranks 11th in terms of Innovation and Sophistication Factors.

(World Economic Forum, 2013) The education system is designed to nurture the

inherent capability to innovate. Educational programs from kindergarten through

postgraduate levels reward scientific and engineering excellence.

The government plays a proactive role in streamlining policies towards market

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trends. Its synchronized investment in supporting infrastructure and resources

ensures that Singapore gains an early-mover advantage in the global R&D.

c) Industry Response to Government Commitment

Private sector response to government policy for R&D has been very encouraging,

accounting for about two-third of total expenditure in R&D in Singapore.

Source: A*STAR, ―National Survey of R&D (2002 - 2011)‖

Figure 2.1.5 Total R&D Expenditure and Private Sector R&D Expenditure

(i) Enhanced firm performance

The knowledge intensive biomedical sector has grown to 19.6% of all

manufacturing output because of the inflow of top-ranked talent, strong base of

biomedical research capabilities and state-of-the-art infrastructure.

0

1000

2000

3000

4000

5000

6000

7000

8000

R&D Total

Private sector R&D

expenditure, 1998 - 2008

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Source: Based on Economic Survey of Singapore, 2010, MTI, 2011

Figure 2.1.6 Share of Biomedical Manufacturing in Total Manufacturing in Singapore

(ii) Enhanced university performance

At a Wiley-Blackwell Research Seminar in March 2008, Blackwell‘s

bibliometrics director Iain Craig provided data illustrating that the research output

of Singapore was on track to reach and then exceed the world average in the next

few years, having increased by some 72 percent from 2000 to 2007. With an R&D

expenditure of US$3.1 billion in 2006, Singapore generated publications at a rate

of 0.3 publications per researcher, higher than that of either China or Japan.

2) Approximate Investment Size and Main Investors

a) Bioclusters in Singapore

Singapore has developed by the inviting foreign invested enterprises.

Electronic industries, such as television and a semi-conductor, have been invited to the

70s. Petrochemical industries, such as ethylene plants and its down streams, were

invited to the 80s. IT and information and telecommunications are remarkable as global

trends to the 90s. Singapore also began to put a strength into attraction of these

companies. When it was in the 21st century and the government raised a biomedical

industry. 15 bio-advanced companies were invited by 2010, and it determined to

become a local centre of pharmaceutical development and a medical investigational.

The overseas office of Singapore Economic Development Administration (EDB)

performed the attraction activities of foreign invested companies. The efforts of

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attraction were achieved fruitfully and steadily. Six companies of top ten

pharmaceutical companies in the world came and started operation. Moreover,

relocation of the research and development division also progresses and the presently

bio-cluster has been formed.

Singapore aims at 21 century industry. Production amount in 2007 recorded by 4times,

S$24 billion and it became 4 times compared with 2000. It almost same as 2015 target,

S$25 billion and it is almost 4 times compare with year 2000. Number of Employee also

increased to13,000 in 2009.

(i) Historical Background of Biocluster Success in Singapore

Singapore aims at systematic biomedical research-and-development centre from

the basic study, the clinical test, the product and process development, the

production and manufacture in a full scale, and healthcare service. The historical

reason why the bio-cluster was formed for Singapore for a short period is

existence of the intention that EDB, that is, the government had strong policy. The

government had strong mind that the biomedical industry should be developed as

a leading industry in the 21st century. Although bio-industry did not exist in

Singapore further from the first, it was positively in charge of attraction of

foreign-invested firms. Last reason was that foreign experts in bio technology

were invited aggressively.

(ii) Advantage and Disadvantage in Singapore Biocluster

A. Advantage

I. Recognition and approval can be performed unitary.

II. Medical care data were approved by the U.S. FDA

III. Pursuit patient data for 10 years

IV. Clarify clinical test organization

V. Invitation worldwide medical maker and Exhibition

VI. Tax incentive

VII. Understanding Chinese medicine

VIII. Acceptance of a diagnoses and therapeutic of a foreigner

including medical tourism

B. Disadvantage

I. Weak for New medicine field

II. Personnel expenses are high and a manufacturing cost goes up compared

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with the countries in Southeast Asia

III. Singapore market is small

IV. Since it is a production base of a foreign company, a loyalty is not

generated.

b) Main Bio Cluster and Other Facilities in Singapore

Source: JICA Study Team

Figure 2.1.7 Main Bio Cluster and Other Facilities in Singapore

c) Plans of Each Biotech Park in Singapore

(i) One-North

One-North is a 2 sq km development within Singapore‘s science and education

talent belt. It hosts research facilities and business park space for Biomedical

Sciences, Infocomm Technology (ICT), Media, Physical Sciences and

Engineering. It encompasses the National University of Singapore, the National

University Hospital, part of the Nanyang Technological University, Singapore

Science Park, and the Ministry of Education. Biopolis, the bio-cluster and the

Fusionopolis, a cluster for ICT, Media, physical sciences and engineering R&D,

are located within One-North.

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Source: http://www.skyscrapercity.com/showthread.php?t=149241&page=39

http://www.pharmaceutical-technology.com/projects/biopolis/biopolis4.html

(Biopolis Biomedical Research Hub, 2013)

Figure 2.1.8 One-North Master Plan

(ii) Biopolis

Biopolis has been planned as ―the biomedical hub of Asia,‖ a city within a city

intended for scientists, researchers, and entrepreneurs. It is designed to attract

scientists from all over the world who will come for the quality of scientific

research and the cosmopolitan work environment. Biopolis offers office space,

from workstations to buildings; support facilities like common areas and an

auditorium; and retail units on rent. Many facilities have been designed to be

shared by scientists and engineers in related disciplines, including the Zebra fish

facility, bioreactor, electron microscopy, proteomics, MRI, histology, x-ray

crystallography, DNA sequencing, flow cytometry, lab supplies, media

preparation, and glassware washing.

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Table 2.1.2 Fact Sheet for Biopolis

Phase 1 2 3 4 5

Year 2006 2011 2013

(ongoing)

Gross Floor Area 185,173 37,000 41,500 32,000 46,182

Cost S$500 mil S$70 mil $250 mil S$87mil

Developer JTC

(Public)

Private

( Crescendas

Bionix)

Private

(Procter &

Gamble)

Private

(Ascendas)

Source: Data from (Ho, 2007), (Biopolis Biomedical Research Hub, 2013),

(SG Property News, 2011)

Biopolis Phase 3 was awarded to Crescendas Group by JTC Corporation under a

design-build-own-operate basis with a 30+30 year lease. Crescendas Bionix, a

member of Crescendas Group, is the vehicle for the project. The consultants for

this phase of the project were Jurong Consultants. The facility will focus on

medical technology research and clinical & translational research. (Biopolis

Biomedical Research Hub, 2013)

Development for phases 4 and 5 of Biopolis is currently underway. Phase 4 has

been taken up by Procter & Gamble for its Singapore Innovation Centre, whilst

Phase 5, by Ascendas, will provide 46,182sqm of biomedical research facility for

additional laboratory space, including ready-fitted laboratories (i.e. Shell-plus

laboratory) which cater to biomedical SMEs and start-ups through saving the

companies time and resources during their initial setup phase. (Biopolis

Biomedical Research Hub, 2013)

Key Customers:

Major companies, such as the Novartis Institute for Tropical Diseases and the

GlaxoSmithKline Center for Research in Cognitive and Neurodegenerative

Disorders, have built a presence in the Biopolis.

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Source: http://www.pharmaceutical-technology.com/projects/biopolis/biopolis4.html)

Figure 2.1.9 Biopolis Development Plan by Phase

4th Floor (GridAsia & OGF Meeting Floor)

3rd Floor (Breakout Rooms & Secretariat Room)

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2nd Mezzanine Floor

2nd Floor

Source: http://www.pharmaceutical-technology.com/projects/biopolis/biopolis4.html

Figure 2.1.10 Floor Plan of Matrix Building

Source: http://www.ascendas.com/downloads/Brochure_Neuros.pdf

Figure 2.1.11 Neureos (Phase 2 Building ) Floor Plans and Schematic Section

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Source: http://www.absa.org/abj/abj/071204behrmann.pdf

Figure 2.1.12 Novartis Institute for Tropical Diseases (NITD), BSL-3 Unit Set-up

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(iii) Fusionopolis

Another park, Fusionopolis, located about half a mile from the Biopolis, focuses

on integration of physical sciences and engineering with biomedical sciences; and

of academic and industrial science, to speed research results toward commercial

application. Fusionopolis has public- and private-sector labs, homes, service

apartments, hotels, a shopping mall featuring smart-shopping technologies, food

and beverage outlets, and an experimental theatre for art performances.

It focuses on the physical sciences and engineering research, especially:

-Energy (fuel cells, organic photovoltaics)

-Home 2015 (assistive technologies for health monitoring and rehabilitation,

medical devices and technology

-Aerospace (computational fluid dynamics, manufacturing processes,

automation)

- Nanotechnology

- Sensors and sensor networks (wireless communication and robotics for remote

monitoring)

- Cognitive science, with future applications in social robotics

A*STAR plays a role in integrating the work of research institutes with MNCs,

SMEs, and start-ups, as well as with other agencies, such as the Economic

Development Board and SPRING Singapore.

Towers A & B of Fusionopolis Phase 2A house dry and wet laboratories and

business park space. Tower C consists of a cluster of high specification laboratory

spaces, including multi-storey stacked vibration-sensitive laboratories and clean

rooms, SERC Research Institutes of DSI, Institute of Microelectronics (IME),

Institute of Materials Research and Engineering (IMRE) and Singapore Institute

of Manufacturing Technology (SIMTech). (A*STAR, 2011)

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Source: http://inhabitat.com/fusionopolis-singapore%e2%80%99s-new-green-skyscraper

/attachment/12787/

Source:http://www.jtc.gov.sg/RealEstateSolutions/PublishingImages/one-north/

Fusionopolis-SiteMap.jpg

Figure 2.1.13 Fusionopolis

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Source: http://img.photobucket.com/albums/v133/RafflesCity/fusionopolis.jpg

Figure 2.1.14 Outline of Fusionopolis

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Note: Showing office (R&D) spaces in green

Source: http://www.kilostudio.net/awards/2008/fusionopolis/

Figure 2.1.15 Schematic Floor Plans of Fusionopolis

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Source: http://www.kilostudio.net/awards/2008/fusionopolis/

Figure 2.1.16 Single Floor Plan Schematic

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Source: http://www.ice.ci.ritsumei.ac.jp/~ruck/PAP/wasa12CGT.pdf

Figure 2.1.17 Fusionopolis, Level 13 Connexis (North Tower)

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Source: http://www.designbuild-network.com/projects/solaris-fusionopolis

/solaris-fusionopolis3.html

Figure 2.1.18 Plan of Solaris Fusionopolis (Phase 2)

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(iv) Tuas Biomedical Park

Tuas Biomedical Park (TBP) is a world-class manufacturing hub, hosting process

development and manufacturing operations of major pharmaceutical,

biotechnology and medical technology companies; equipped with power lines,

telecommunication lines, water and gas supplies, established sewerage system

and road network. Third parties are providing utilities such as steam, natural gas,

chilled water and waste treatment services.

TBP presents a plug-and-play environment that reduces lead time to commence

commercial operations, and offers good access to logistics.

Table 2.1.3 Fact Sheet for Tuas Biomedical Park

Total Site Area (m2) 36,00,000

Developer JTC (Public)

Key Customers TBP is home to a host of global biomedical players,

including GlaxoSmithKline, Lonza, MSD GmbH,

Novartis, Pfizer and Roche.

Source: Tuas Biomedical Park, 2013

Source: Tuas Biomedical Park, 2013

Figure 2.1.19 Tuas Biomedical Park

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(3) South Korea

1) Purpose and Background for Cluster Location

Bio industry has been recognized as one of the future engines for growth and required to

drive the world economy in the wake of the success of information and communication

technology. Through convergence with other cutting-edge technologies including

information technology and nano technology, it could lead innovation in the medicine,

chemical, energy, agricultural and food industries among others, as well as creating new

value-added industrial groups.

Although every country in the world is making effort for developing to produce big added

value, research and development are actively done by university, a research institute,

bio-venture, etc. even in Korea, and as results, the big outcomes are also produced.

In recent years, Korean biotechnology industry has achieved big success under

governmental support. The background is a) talented human resource development, b)

governmental strong supports and c) continuously prepared hardware. Life science

industry has become potential high developing power due to the expanding collaboration

between academic and industry.

a) Basic Framework and Direction of Technology Development in Korea

The institutional centers of Korean science and technology policy in the 1980s were the

Ministry of Science and Technology (MOST), which supported basic and applied

research through the Korean Institute of Science and Technology (KIST) and its

specialized research institutes, and the Ministry of Trade and Industry (MOTIE), which

promoted purely industrial research.

MOST is now called the Ministry of Education, Science and Technology (MEST), and

MOTIE became the Ministry of Knowledge Economy (MKE).

From the 1980s, the National R&D Program (NRDP) had been the focus of MOST‘s

activities. This was supplemented by a major new program: the 21st Century Frontier

R&D Program began in 1999 to develop science and technology competitiveness in

emerging fields, and over the subsequent decade the government poured $3.5 billion

into twenty-three projects in such fields as bioscience, nanotechnology, space

technology. Each grant has been for roughly $10 million.

The Creative Research Initiative (CRI) started in 1997, intended to support a shift

―from imitation to innovation‖ research. Fifty-seven research centers were selected,

each receiving $500,000 per year. The National Research Laboratory (NRL) chose

several research centers of excellence, aimed at improving competitiveness. Individual

projects receive up to $250,000 per year, and the majority of projects are at universities

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and research institutes, with only about ten percent at corporate research labs. The

Nanotechnology Development Plan of 2001 was dedicated to this emerging technology,

spends about $170 million per year, and established two new national nanotechnology

labs. The Biotech 2000 Plan brought together several ministries with interests in

development of biotech, and the plan was intended to boost the biotech component of

the NRDP.

The Korean government prides itself on steadily increasing aggregate figures for R&D

expenditures and numbers of researchers. In 2008, Korea devoted 345 billion won

($286 million) to R&D, accounting for 3.37 percent of GDP, almost a full percent

increase over 1998 (it reached 3.48% in 2010). In PPP terms, it equaled about half of

the figure for the U.S. Also in 2008, the government employed over 4,000 researchers

in its R&D labs, nearly doubling the figure for 2000. Researchers employed in

corporate labs were 197,000, and private facilities accounted for two-thirds of both

total spending and researchers, while eighty percent of the rest toiled at universities.

Unsurprisingly, most corporate researchers work on applied technologies. As

impressive as these figures may be, Korea still lags in amount of expenditures per

researcher, behind Japan, the U.S., and several Western European nations. Also,

amounts of expenditures as a ratio of sales lag for many industries.

b) History of Biotechnology in Korea

The Korean government has begun promoting from the mid 1980‘s and after

establishing a basic plan for the promotion of biotechnology ―Biotech 2000‖ in 1994,

started to coordinate government policies and expand its investment in R&D greatly.

Main Issues of History of Biotechnology in Korea are summarized in Table 2.1.4.

Table 2.1.4 Main Issues of History of Biotechnology in Korea

Year Main Issues

1983 Genetic Engineering Promotion Law was established

1985 Korea Research Institute of Bioscience & Biotechnology (KRIBB) was

established

1994 Basic Plan for the Promotion of Biotechnology (―Biotech 2000: 1994-2007‖) was

established

1998 Brain Research Promotion Law was implemented and Basic Plan for the

Promotion of Brain Research (―Brain tech 21: 1998-2007‖) was established

2004 Novel Biomedicine and Organs industry was designated as one of the next

generation growth engines

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2006 The 2nd Framework Plan for the Promotion of Biotechnology (―Bio-Vision 2016:

2007-2016‖) was established

2007 The 2nd Framework Plan for the Promotion of Brain Research (2008-2017) was

announced and The Master Plan for National Life Resources was established

2008 Science and Technology Basic Plan ―577 Initiative‖ was established and ―BT

Committee‖ under the National Science and Technology Council was formed

Source: JICA Study Team

c) Vision for Biotechnology in Korea

Bio-Vision 2016 was established the direction of the development of Korean

biotechnology over a 10-year period up until 2016 and it was published to achieve a

goal of making Korea a biotechnology leader, according to a vision or realizing a sound

―Health Life‖ and ―Prosperous Bioeconomy‖, targeting to join the group of global top 7

biotechnology nations. Main goals for the vision are summarized in Table 2.1.5.

Table 2.1.5 Main Goals for the Bio-Vision 2016

Category 2006 2016

No. of science-technology papers published

(National ranking )

12th 7th

Competitiveness in patented technology

(National ranking )

15th 7th

No. of R&D manpower

(Postgraduate degrees )

9,500 17,300

Industrialized market value (Korean Won (KRW)) 2.7 trillion 60 trillion

Source: JICA Study Team

For the development of the industry, the following points should be strengthened:

- Strengthening an efficient comprehensive coordination system

Multi-ministerial coordination/Efficient budget allocation system

- Acquiring of creative original technology

Facilitating overall R&D activities/Core and fusion technologies needed

- Developing of advanced industrial infrastructure

Realignment of industrial systems/Securing the commercialization

infrastructure

- Promoting of bioethincs and a culture of research integrity

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Social consent for safety ethics/Promotion of ELSI research

d) Governmental Commitment to Promote Biotechnology

Biotechnology has a shorter history in Korea than IT industry which is the leading

industry of Korea. Over the past decade, however, it has grown substantially. In the

1990s, most R&D was pursued by universities and a few pharmaceutical firms, but

Korea now has a diversified R&D capacity in bio-science and product development.

Medical uses account for nearly sixty percent of the industry, by income, and food

products amount to nearly forty percent. The industry bounced back from a major

scandal involving human biotech experiments, and now boasts roughly 600 firms, most

of which are located in the Seoul area. The industry employs over 12,000, over half of

whom are researchers, and the rest in production. The industry produced $2.42 billion

in volume, along with $1.1 billion in exports, in 2004.

Investment of Korean government in Biotechnology 1994 through 2008 is shown in

Figure 2.1.20.

Source: Korea Ministry of Education, Science and Technology, 2009

Figure 2.1.20 Government Investment in Biotechnology (1994 ~2008)

Key investment fields related to biotechnology include four areas of green ocean, risk

science, mega trend science and national platform technology. Main project areas and

related critical technologies are summarized in Table 2.1.6.

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Table 2.1.6 Main Project Areas and Related Critical Technologies

1

Technology Areas Industrial Technologies [Green Ocean]

Projects Developing emerging technologies in the areas of drug, health and

medical care for which market sizes are expected to expand in the

future due to the aging society

Critical

Technologies

Next-generation system S/W, cancer diagnosis and treatment, brain

science, drug discovery and development technology, etc

2

Technology Areas National Issues-related Technologies [Risk Science]

Projects Technology development in the area of current issues related to

healthy life of people including new types of disease such as mad

cow disease and pathogeric avian influenza, and food safety

Critical

Technologies

Immune disease and infectious disease response, food safety

evaluation, IT nano-device technology, etc

3

Technology Areas Global Issue-related Technologies [Mega Trend Science]

Projects Technology development to cope with common issues of human

kind such as energy and resources, climate change, environment and

food, and to occupy vantage point in the future market

Critical

Technologies

New and renewable energy (solar energy, wind energy, bioenergy,

etc), Environment conservation and restoration technology, etc

4

Technology Areas Basic and Convergent Technologies [National Platform Technology]

Projects Developing platform and convergent/composite material

technologies with substantial socioeconomic effect, which become

the base of next-generation technology innovation

Critical

Technologies

Drug delivery technology, Biochip and biosensor, etc

Source: Swiss Business Hub Korea, ―Bio Technology Industry in Korea‖

e) Strengthening of Industrial Capacity

834 companies including more than 600 venture companies are involved in the

biotechnology sector, and more than 20,000 people are employed in the industry.

Market size of biotechnology in Korea from 2004 to 2009 is shown in Figure 2.1.21.

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Source: Korea Pharmaceutical Manufacturers Association

Figure 2.1.21 Market Size of Biotechnology in Korea (2004 - 2009)

Korean biotech industry has shown the growth rate of 16.8% of an annual average in

these five years (2005 - 2010). Moreover, the investment to the biotech industry by the

Korean government is increasing for about 3 times in 2009 compared 2003. The

research and development division has the largest budget, and it has been intensively

invested into infrastructure buildings and personnel development. The base of the

Korean biotech industry policy has based on laws of ―Life Science Development‖ by

the " of Educational Office of Science and Technology, and the "Healthcare technical

promoting" by the health-and-welfare household division which focusing development

of original technology and improving national healthcare. It is the stage which is

making the legal and institutional base which promotes the industrialization of

biotechnology. For raising Korean biotech industry up to the industrial level from now

on, it is necessary to invest R&D of bio-field with diversity investment in respect of

quantity and quality. It is also necessary to make it develop efficiently into

industrialization with appropriate selection and concentration. Presently the Korean

government revise the law of ―Life Science Development‖ to law of ―Life Science

Development and Industrialization Promotion‖ to proceed more industrialization. By

this revision, the government wants to strengthen bio industry fundamentals,

supporting R&D, governmental approval system, intellectual property management,

enterprise, aiming promoting bio technology industrialization.

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2) Approximate Investment Size and Main Investors

a) Present situation of regional biotechnology clusters in Korea

Korean government has built 20 regional bio-industry infrastructure on the basis of the

regional characteristics from 1998 until 2009 as shown in Figure 2.1.22

Source: Ministry of Knowledge Economy (MKE)

Figure 2.1.22 Present Situation of Regional Biotechnology Clusters

Korean government announced the "extensive industrial cluster building method" in

2009 and employed that the outcome of cluster enterprises reflected into local

development policy efficiently.

The whole country is divided into three districts, and it concentrates on life medicine,

healthcare, animals practical use technique, etc., in Dae Jeon/Chung Cheong Dong

district. Jeolla-do and Chung Cheong Dong area is concentrated into bio-agricultures

specializes in practical use of bioengineered foods and vegetation resources. Gang

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Won/Gyeongsang district is intensively raised with emphasis on practical use of life

environments, process and functional ingredients, and marine resources, etc.

b) Outline of Main Biotech Parks in Korea

(i) High-Tech Medical Complex, Daegu Innovation City

High-Tech Medical Complex is a high-tech medical industry cluster that supports the

commercialization of the domestic medical industry in a bid to strategically nurture

cutting-edge medical equipment and new drug industries.

A. Purpose

Provide a comprehensive support to the domestic medical industry in order to

strategically nurture cutting-edge medical equipment and new drug industries at

the national level

B. Vision and Strategy Purpose

I. Vision

To become a global medical R&D hub which has the best capability in the

high-tech medical industry

II. Goal

To provide a world-class research area to anyone with ideas

III. Practical strategies

Green and high-tech medical complex to develop cutting-edge new medicine,

and medical equipment

C. Overview

I. Location/Size

Within the Daegu Innovation City in Sinseo-dong

1,030,000 m2 (innovation city 4,220,000 m2)

-Government facilities including new drug development support center, and

cutting-edge medical equipment development support center: 76,000 m2

-Communication center, research institutes, and venture towns: 954,000 m2

II. Period

2009 - 2038(Construction : 2009 - 2012)

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III. Total budget

KRW 5.6 trillion (KRW 2 trillion financed by the state government, KRW 0.3

trillion by the city and provincial government, KRW 3.3 trillion by the private

sector)

IV. Government budget

KRW 1,964 trillion (KRW 824.6 billion for facility operation, 1.1396 trillion for

R&D investment)

D. Expected benefits

Development of global high-tech products (16 new drugs, 18 high-tech medical

devices) will result in increase in production and employment of KRW 82 trillion

of production increase, 380,000 of job creation and KRW 40 trillion of

value-added (Annual net revenue from one drug development equals to exporting

3 million cars).

The construction of the complex creates a synergy effect across the local economy.

E. Blueprint for the high-tech medical complex

Research and application-oriented medical complex that puts research results into

action.

Establishing R&D infrastructure to support the selection and design of innovative

new drugs, manufacturing of prototypes, performance evaluation(cutting-edge

medical equipment), and clinical trial.

F. Bird's eye view

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Source: Korea Trade-Investment Promotion Agency, Invest Korea Homepage

Figure 2.1.23 Bird's Eye View of High-Tech Medical Complex

G. Location map of the complex

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Source: Korea Trade-Investment Promotion Agency, Invest Korea Homepage

Figure 2.1.24 Location Map of the Complex

Source: Korea Trade-Investment Promotion Agency, Invest Korea Homepage

Figure 2.1.25 Medical Complex and Development of Surrounding Areas

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H. Outline of facilities

Table 2.1.7 Outline of High-Tech Medical Complex

Facility Size

(m2)

Use

New Drug

Development Support

Center

70,100 evaluation of candidate

drugs, joint development

Ministry of

Education,

Science and

Technology

High-tech Medical

Equipment

Development Support

Center

design of medical equipment,

manufacturing, evaluation

support, etc.

Ministry of

Knowledge and

Economy

Lab Animal Center pre-clinical trial, etc. Ministry of

Health and

Welfare

Clinical Test and

Production Center

production and supply of

clinical trial sample

Ministry of

Health and

Welfare

Communication

Center

17,600

(8 floors above ground,

1 floor underground)

venture company, strategy

and planning headquarters,

amenities

Daegu city

Private sector zone 388,446 cutting-edge clinical trial

center, venture research

center

Private

Source: Korea Trade-Investment Promotion Agency, Invest Korea Homepage

I. Features of main facilities

I. New Drug Development Support Center

Main tasks

-Provide safety and toxicity evaluation on substance discovered and requested by

academics and industries

-Support the discovery of optimal candidate substance through repeated practice

of optimization

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Size

Table 2.1.8 Size of New Drug Development Support Center

Area 4,062.81 m2

Total building

floor area 23,016.04 m

2

Floor 9 floors above ground,

1 floor underground

Construction

cost

KRW 57.4

billion

Ground-breaking September 2011 Completion of

construction July 2013

Source: Korea Trade-Investment Promotion Agency, Invest Korea Homepage

Budget

Table 2.1.9 Budget for New Drug Development Support Center

Cost 2010 2011

Total KRW 16.5 billion KRW 15.5 billion

Facility cost KRW 15.9 billion KRW 13.4 billion

Equipment cost - KRW 1.3 billion

Construction cost KRW15.9 billion KRW 12.1 billion

Operating cost KRW 600 million KRW 2.1 billion

Source: Korea Trade-Investment Promotion Agency, Invest Korea Homepage

II. High-tech Medical Equipment Development Support Center

Main tasks

-Establish comprehensive infrastructure to support the development of

cutting-edge medical equipment

- Support the development of products with high growth potential such as

medical imaging devices, and medical robots

Size

Table 2.1.10 Size of High-Tech Medical Equipment Development Support Center

Area 4,406.49 m2

Total building

floor area 10,890.17 m

2

Floor 5 floors above ground,

1 floor underground

Construction

cost

KRW 34.4

billion

Ground-breaking September 2011 Completion of

construction July 2013

Source: Korea Trade-Investment Promotion Agency, Invest Korea Homepage

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Budget

Table 2.1.11 Budget for High-Tech Medical Equipment Development Support Center

Cost 2010 2011

Total KRW 12.2 billion KRW 7.4 billion

Facility cost KRW 11.9 billion KRW 6.1 billion

Equipment cost - KRW 1.7 billion

Construction cost KRW11.9 billion KRW 4.4 billion

Operating cost KRW 300 million KRW 1.3 billion

Source: Korea Trade-Investment Promotion Agency, Invest Korea Homepage

III. Lab Animal Center

Main tasks

-Support animal test and the development of new drugs and medical equipment

within the complex

-Provide a stable supply of lab animals to research institutes within the complex

-Produce and provide various disease-model animals

-Support the training of specialists and animal test of local industry and academia

-Store human body resources as a bio resource center

Size

Table 2.1.12 Size of Lab Animal Center

Area 3,334.13 m2

Total building

floor area 8,716.87 m

2

Floor 3 floors above ground,

1 floor underground

Construction

cost

KRW 31.3

billion

Ground-breaking September 2011 Completion of

construction July 2013

Source: Korea Trade-Investment Promotion Agency, Invest Korea Homepage

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Budget

Table 2.1.13 Budget for Lab Animal Center

Cost 2010 2011

Total KRW 9.7 billion KRW 10.7 billion

Facility cost KRW 9.5 billion KRW 10.1 billion

Equipment cost - KRW 4.1 billion

Construction cost KRW 9.5 billion KRW 6.0 billion

Operating cost KRW 200 million KRW 600 million

Source: Korea Trade-Investment Promotion Agency, Invest Korea Homepage

IV. Clinical Test and Production Center

Main tasks

-Support the complete production of new drug makers in Korea by classifying

drugs into two forms: anticancer drugs and tablets and capsule drugs

-Provide consulting on GMP specialist education programs, and GMP

equipment-related education, and global network service to upgrade GMP

operation

Size

Table 2.1.14 Size of Clinical Test and Production Center

Area 4,214.99 m2

Total building

floor area 6,513.84 m

2

Floor 1 floors above ground,

1 floor underground

Construction

cost

KRW 26.6

billion

Ground-breaking September 2011 Completion of

construction July 2013

Source: Korea Trade-Investment Promotion Agency, Invest Korea Homepage

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Budget

Table 2.1.15 Budget for Clinical Test and Production Center

Cost 2010 2011

Total KRW 8.9 billion KRW 17.2 billion

Facility cost KRW 8.6 billion KRW 16.7 billion

Equipment cost - KRW 12.0 billion

Construction cost KRW 8.6 billion KRW 4.7 billion

Operating cost - KRW 600 million

Source: Korea Trade-Investment Promotion Agency, Invest Korea Homepage

V. Communication Center

Main tasks

-Support the commercialization, R&D of leading research institutes

-Execute the joint task of foundation (establishment of business plans,

promotion) and create synergy effects among centers

Size

Table 2.1.16 Size of Communication Center

Area 2,558.69 m2

Total building

floor area 17,702.01 m

2

Floor 8 floors above ground,

1 floor underground

Construction

cost

KRW 34.2

billion

Ground-breaking September 2011 Completion of

construction July 2013

Source: Korea Trade-Investment Promotion Agency, Invest Korea Homepage

Budget

Table 2.1.17 Budget for Communication Center

Cost 2010 2011

Total KRW 2.0 billion KRW 6.0 billion

Fund,etc. - KRW 2.0 billion

Operating cost KRW 2.0 billion KRW 4.0 billion

Source: Korea Trade-Investment Promotion Agency, Invest Korea Homepage

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J. Daegu-Gyungbuk High-tech Medical Industry Promotion Foundation

I. Foundation basis

Article 11 of the Special Act on designation and support of high-tech medical

complex

II. Corporation characteristics

Non-profit organization under Civil Code Article 32

III. Foundation direction

-Established as a single corporate entity considering the harmony between

administrative support function and efficiency

-Participation from the government, and the private sector (Daegu city and

Gyeongsang province also participate)

-Operating committees are set up at each center

IV. Main functions

-Secure competitiveness of the medical industry by establishing the

infrastructure for high-tech product development

-Support research on the medical industry

-Establish network where academia, industry and government agencies can

communicate together

-Attract investment to revitalize the local medical industry

-Provide efficient management in cooperation with support offices in the

complex

V. Organization

chairman, board of directors, 4 centers, 1 headquarters, 6 head offices, 11

departments and 49 teams

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Source: Korea Trade-Investment Promotion Agency, Invest Korea Homepage

Figure 2.1.26 Organization Chart of Daegu-Gyungbuk High-Tech Medical Industry Promotion

Foundation

(ii) Jeju Healthcare Town Project

Jeju International Free City's major project designed to provide a global medical

environment for attracting domestic and overseas companies and facilitating the

medical industry

A. Vision

Establishing a comprehensive medical complex providing combined services of

medicine and tourism, Jeju's representative industry, which will build the open

healthcare base at the international level by building infrastructures to develop the

region into a major hub of the medical tourism industry

B. Location

Donghong-dong and Topyeong-dong, Seogwipo City

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Source: Korea Trade-Investment Promotion Agency, Invest Korea Homepage

Figure 2.1.27 Location of Jeju Healthcare Town

C. Area

1,539,000 m2

D. Period

2008 - 2018

E. Expense

KRW 772.0 billion (KRW 172.0 billion financed by the public sector, 600.0 billion

by the private sector)

F. Facilities

I. Wellness Park

Establishing the medical and resort complex specializing in health care and

relaxation

-Membership resort & Water park, Thalasso Resotel, Wellness Mall

II. Medical Park

Establishing a comprehensive medical complex that provides cutting-edge

medical services

-Specialized hospital, medical examination center, long-term care town

III. R&D Park

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Establishing a medical research complex that conducts the study on bio medicine

and specialized medical sectors

- Medical R&D Center, Anti-Aging Center, Rehabilitation Center

Source: Korea Trade-Investment Promotion Agency, Invest Korea Homepage

Figure 2.1.28 Bird‘s Eye View of Jeju Healthcare Town

G. History

-Dec. 2006, Designation of a new major project titled "A Comprehensive Plan on

Jeju International Free City"

-Dec. 2009, Approval for the development project of Jeju Healthcare Town

-Oct. 2010, Transfer of the ownership of the industrial site

-Nov. 2010, Designation and announcement of Jeju Investment Promotion Zone

-Feb. 2011, Implementation of the project

-Dec. 2011, Selection of priority negotiation partner in Seowoo-Zhong Da Reaa

Estate Consortium

-Dec. 2011, Conclusion of MOU with China's Greenland Group

-Dec. 2011, Starting land preparation construction

-Jan. 2012, Kick-off Meeting organized by Greenland Group

-Jan. 2012, Kick-off Meeting organized by Seowoo-Zhong Da Reaa Estate

Consortium

-Jan. 2012, Kick-off Meeting organized by Seowoo-Zhong Da Reaa Estate

Consortium

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-Jul. 2012, Conclusion of MOU with Shanghai-based Greenland Group for

investment

-Oct. 2012, Conclusion of contract with Shanghai-based Greenland Group &

Starting the first-phase construction of condominiums

(iii) Osong Biovalley

A. Vision & Goal

Source: Korea Trade-Investment Promotion Agency, Invest Korea Homepage

Figure 2.1.29 Vision of Osong Bio-Valley

B. Osong High-tech Medical Complex

I. Location:

Inside Osong Bio-health Science Technopolis (1,131,000m2) located in

Gangwoe-myeon, Cheongwon-gun, North Chungcheong Province

II. Period: 2009-2038

III. Project cost: KRW 4.3 trillion

IV. Goal: Global research cluster

V. Main Facilities

-6 R&D supporting institutions (including the new drug development supporting

center)

-5 bioresearch town (including National Biobank of Korea)

- Biobiz town (including the center for venture research)

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-20 private R&D institutions, UN cooperation center for biological science

VI. Blueprint for High-tech Medical Complex

Source: Korea Trade-Investment Promotion Agency, Invest Korea Homepage

Figure 2.1.30 Blueprint for High-Tech Medical Complex

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VII. Plot Plan for Facilities

Source: Korea Trade-Investment Promotion Agency, Invest Korea Homepage

Figure 2.1.31 Plot Plan of Osong Bio-Health Science Technopolis and High-tech Medical

Complex within the Technopolis

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Source: Korea Trade-Investment Promotion Agency, Invest Korea Homepage

Figure 2.1.32 Plot Plan of High-Tech Medical Complex

C. Osong Bio Technopolis (Osong 1 Industrial Complex)

The only state-run technopolis for the bio-industry initiated by the Korean

government

A very attractive investment complex that is blessed with a favorable location, and

various benefits and information infrastructure, which help resident member

companies become among the most competitive internationally

I. Vision of Osong Bio Technopolis

Administration-centered integration city

-Site relocation: Ministries and offices to be relocated

-Total area: 296,91 k m2

-Project period: Ground breaking for construction in 2007 and completely

relocated by 2012

A new Osong city under construction

-To construct the future-oriented city infrastructure with comfortable dwelling

facilities, educational environment and ubiquitous system for the employees

of the Osong Bio-Health Science Technopolis Institute

-Total area: 24.20 k m2 (Planned population: one hundred thousand)

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-Project period: From 2003 to 2020

II. Location

The whole area of Gangwoe-myeon, Cheongwon-gun, Chungcheongbuk-do

III. Area: 4,633,000 m2

IV. Period: 1997-2008

V. Project cost: KRW 520 billion

VI. Goal: Bio-complex

VII. Main Facilities

- Health, Technology Administration Complex (6 state agencies)

-36 pharmaceutical companies, 18 medical instrument companies

-4 healthy functional food companies

D. Osong 2 Industrial Complex

I. Location: Jeongjung-ri, Bongsan-ri, Yeonje-ri, Gongbuk-ri

II. Area: 3,332,000 m2

III. Period: 2007-2015

IV. Project cost: KRW 769.6 billion

V. Goal: Bio-complex

VI. Main Facilities

- Initiative university in the convergence area of industry and academia

- Graduate school for biotechnology convergence, independent private high

school

- Biocentral park

- Medicine, medical instruments and other biotechnology companies

E. Location and Floor Plan of Osong Biovalley

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Source: Korea Trade-Investment Promotion Agency, Invest Korea Homepage

Figure 2.1.33 Location of Osong Biovalley

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Source: Korea Trade-Investment Promotion Agency, Invest Korea Homepage

Figure 2.1.34 Plot Plan of Osong Biovalley

F. Reduction in Rent

-100% reduction for business of value in excess of one million dollar and

accompanying cutting-edge technologies

-75% reduction for general manufacturing business of value in excess of five

million dollars

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(iv) Gyeongbuk Bio Industry Cluster

Gyeongbuk Bio Industry Cluster is northern bio cluster based on agricultural

and bio resources, and traditional medicine. It is aiming at development of a

new growth engine through the convergence of agricultural and livestock

industries, bio technology (BT), energy, and tourism industries.

Main institutes in the region are Gyeongbuk Institute for Bio Industry,

Gyeongbuk Institute for Marine Bio Industry, medicinal herb development

center and traditional medicine commercial complex is also located.

A. Creation of a Medicinal Cluster

Ginseng product development center, branch office of Korea Research Institute of

Bioscience and Biotechnology (continuous effort to push for the establishment of

Sangju traditional herb medicine industrial complex)

B. Korean Food Cluster

Bio venture plaza in Andong, branch office of Korea Food Research Institute

(association with Gyeongbuk bio industrial complex)

C. ―Agriculture Amenity‖ Complex

―Ginseng land‖ in Punggi, insect ecological academy in Yecheon,

environment-friendly agriculture theme park

D. Development and Deployment of Bio Energy

Bio energy development center, energy crop complex, bio diesel research and

production facilities

Source: Korea Trade-Investment Promotion Agency, Invest Korea Homepage

Figure 2.1.35 Bird‘s Eye View of Gyeongbuk Bio Industry Cluster

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(4) Taiwan

1) Purpose and Background for Cluster Location

Taiwan has achieved remarkable economic success, having transformed itself in a few

short decades to the technology-driven economic powerhouse that it is today.

Over the past 20 years Taiwan has concentrated on developing its high-tech industries,

and is now a world leader in the development and production of electronic, information

technology (IT), computer and semiconductor products.

Taiwan's aim is to achieve the same kind of success and global standing in the industry of

the future - biotechnology.

a) Taiwan's Biotech Advantages

Taiwan has much strength that give it the edge over its competitors in the rest of Asia.

These strengths are due to a combination of existing conditions and to deliberate

planning on the part of the government. These include:

- Existing expertise in high technology, easily transferred to biotechnology

- Strategic location; close to China and straddling Northeast and Southeast Asia

- Strong legal framework

- Highly educated workforce, particularly in IT and biology

- World-class research facilities

- Abundant capital and Asia's most vibrant venture capital industry

- Herbal medicine knowledge and experience

Taiwan also has a highly educated workforce and world-class research facilities.

b) Taiwan Tops in Asian Biotech

Taiwan can already claim the title of Asian leader in biotechnology. In its November

2001 report entitled 'Asia Biotechnology — Asia's Biotechnology dawn,' the

Singapore office of the brokerage division of French-based Societe Generale Group

identified Taiwan as the top biotechnology nation in Asia, reporting that it had in

place many of the elements for a winning strategy. Second after Taiwan was

Singapore, followed by Hong Kong/China, Korea and India. The survey indicated

that Taiwan was particularly strong in IP protection, had a solid industrial

development organizational structure and abundant investment resources.

Taiwan is not resting on its laurels however, and continues to work towards

upgrading the competitiveness of its life science industries.

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c) Biotechnology as Defined in Taiwan

As the term 'biotechnology' is relatively new, it is difficult to define what exactly a

'biotechnology' company is. As a combination of 'biology' and 'technology', such a

definition encompasses the vast range of life sciences and medical disciplines, and all

related technologies. As the dust has yet to settle on this question, the Biotechnology

and Pharmaceutical Industries Program Office, part of the Ministry of Economic

Affairs, has put forward the following definitions:

"Biotechnology is a set of powerful tools that employ living organisms or parts of

organisms to make or modify products, improve plants or animals, or develop

microorganisms for specific uses. Examples of this new 'biotechnology' include

industrial use of recombinant DNA, cell fusion, and novel bio processing."

It is generally understood in Taiwan as:

―The application of technological principles in life sciences‖

Using this latter definition, 'biotechnology' includes the pharmaceutical industry.

Furthermore, because of its ethnic Chinese heritage, Taiwan's pharmaceutical

industry has always included the Chinese medicine industry. In fact, many

manufacturers of Western pharmaceuticals in Taiwan are also producing Chinese

medicinal ingredients and formulations. Similarly, many new biotech start-ups are

conducting research on modern medical uses of traditional Chinese herbs and

medicines.

d) Government development strategy - The Promotion Plan for the Biotechnology

Industry

The strategy and direction of Taiwan's biotechnology industry development is clear

and focused. Industry, institutions and government bodies all follow developmental

guidelines as set forth in the Promotion Plan for the Biotechnology Industry.

This document, a road map defining national industry goals and clearly detailing the

corresponding action steps required to get there, was first written and released by the

Executive Yuan branch of the government in 1995, and has been revised biannually

ever since. The most recent revision of the Promotion Plan was released in March

2003.

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e) Action Tasks

A major aspect of the Promotion Plan is that it has identified specific areas in need of

attention to upgrade not only the local biotech industry but also to enhance the

investment attraction of Taiwan to the overseas life science community. These five

areas of attention are as follows:

- Related laws and regulations

- R&D and application

- Technology transfer and commercialization

- Investment promotion and cooperation

- Marketing information and services

f) Goals

In compiling the Promotion Plan, Taiwan's strengths and capabilities were examined

and a number of industry objectives were decided on. These include the following

four major goals:

- To establish Taiwan as the center for genomic research and development in Asia

- To establish Taiwan as the leading location for human clinical trials in Asia

- To establish Taiwan as a worldwide subtropical floriculture center

- To establish in Taiwan the most vibrant biotech-focused venture capital industry in

Asia.

g) Growth Targets

In addition, the Promotion Plan set the following growth goals:

- US$4.5 billion in new biotech/pharmaceutical industry investment by 2010

- By 2010 at least 18 international-standard biotech companies are to be established

in Taiwan, being either fully locally owned, or mixed local-overseas ownership

joint ventures or collaborations.

h) Taiwan Bio Industries Ready for International Cooperation

Taiwan understands that for its life science industry goals to be met, it needs to more

fully integrate with the international biotech community. By encouraging investment,

joint ventures, biotech technology transfer and research collaboration between its

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local companies and institutions and their overseas counterparts, benefits will come

not only to Taiwan but to all collaborating parties.

To help facilitate internationalization of Taiwan's biotech industry, the government,

planning and promotional organizations have all been working hard to develop the

ideal conditions for attracting international partners and for sustained future industry

growth.

The worldwide biotech community is welcome to examine the unique mix of

advantages and attractions Taiwan has to offer. With its large pool of bio scientists

and high-tech talent, an impressive medical research base including world-class

research institutions, its entrepreneurial 'can-do' business culture, and

last-but-not-least the commitment of the government to fully support the industry, all

add up in Taiwan's favor.

What's more, not only does Taiwan hold distinction as an investment and partnering

location in its own right, its proximity to mainland China and the language, ethnic

and business connections between the two make Taiwan the ideal location as a

stepping stone to China.

As they become more economically developed, it is anticipated that China's citizens

will increase their spending on health and medicine, creating a biomedical and

medical products industry boom. Be a part of this boom by investing in Taiwan.

Taiwan proudly welcomes all international partners to jointly share in the

development and future successes of the nation's newest industry.

i) R&D Investment

In the early 1980s, the Taiwan government listed the biotechnology industry as one of

its industrial development priorities. At that point it began to vigorously promote

research in related industries, as well as encouraging overseas Chinese scientists to

return to Taiwan to offer their experience and expertise to the nation.

Since that beginning, research budgets for life sciences have increased dramatically.

In 2002, the government allocated US$495 million to bioscience research and

development - 29 percent of the total national science budget -and an increase of 46

percent over the previous year's US$339 million.

For the total amount budgeted between 2000 and 2002, the funds were allocated as

follows: 30.4 percent to the R&D budget of the National Science Council, 20.4

percent to the Department of Health, 16.1 percent to the Ministry of Economic

Affairs - whose major task it to promote local industries - 21.6 percent to the Council

of Agriculture, and 11.5 percent to Academia Sinica.

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j) National Research Programs

Life-science focused national development programs initiated by the government

now include the National Research Program for Genomic Medicine, the National

Science and Technology Program for Biotechnology and Pharmaceuticals.

Of these, the National Research Program for Genomic Medicine is the most recent,

and is a major part of Taiwan's goal to become the Asian center for genomic research.

The National Science and Technology Program for Agricultural Biotechnology is

devoted to research in seven major fields: floriculture and ornamental plants, plant

protection, aquaculture, livestock vaccines, plant genetic improvement and

modification, environmental protection, and medicinal plants.

The National Science and Technology Program for Biotechnology and

Pharmaceuticals puts focuses on the development of new drugs, herbal medicine, and

on biochip technologies and analysis methodologies.

k) Division of R&D Roles

Along with the above mentioned government bodies are vigorous R&D programs

being undertaken at the island's many outstanding universities and graduate institutes.

Together with such academic institutes and private industry, the government has

established a clear division of roles for those undertaking R&D within the life

sciences. Each institute involved, whether upstream undertaking basic research

through midstream to downstream at the product-commercialization level, has a

well-defined and coordinated research mission.

For example, the Development Center for Biotechnology (DCB) is a non-profit

research institute and service-provider, undertaking research at the pre-clinical stage.

The DCB has a clear and well-defined mission, serving as a bridge between the

academic and industrial communities. The center not only sources promising

biotechnologies overseas through its BioFronts program, but also has its own

research labs in Taiwan for the refining of such technologies.

The center has GLP-standard experimental animal lab facilities, fully accredited by

the Association for Assessment and Accreditation of Laboratory Animal Care

International (AAALAC), the only such accredited facility in Taiwan. It also has a

cGMP pilot plant for antibodies and proteins, with 300-liter and 500-liter bioreactors

on-site. The DCB bundles these facilities and services to help local companies set

programs and help build alliances between international biotech companies and local

firms.

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Table 2.1.18 Division of R&D Roles Serving Taiwan's Biotechnology and Pharmaceutical Industry Development

Upstream Midstream Downstream

Promotional

units

Academia

Sinica

National

Science

Council

Ministry of

Education

Department

of Health

Ministry of

Economic

Affairs

Council of

Agriculture

Atomic Energy

Council

Ministry of

National

Defense

Industry

Implementing

Institutes

Academia

Sinica

Universities

National

Health

Research

Institutes

Center for

Disease

Control

Center for

Drug

Evaluation

Development

Center for

Biotechnology

Industrial

Technology

Research

Institute

Pharmaceutical

Industrial

Technology &

Development

Center

Food Industry

Research &

Development

Institute

Council of

Agriculture

and its

related

divisions

Taiwan

Agricultural

Research

Institute

Nuclear

Research

Institute

Chungshan

Institute of

Science and

Technology

National

Defense

Medical

Center

Private

Companies

R&D scope Basic

research

Stipulate and

execute

policies and

regulations

Clinical

trials

Public health

New drug

evaluation,

regulation

and

development

Technology

application and

development

Procedures for

scaling up

production

Application

and

development

for animal,

agriculture,

marine and

livestock use

Development of

radioactive

pharmaceuticals

Application

and

development

of national

defense

research for

civilian use

Product

manufacturing

Marketing

Customer

services

Non-profit R&D Organizations

R&D

Institutes

National

Health

Research

Institutes

Industrial

Technology

Research Institute

Pharmaceutical

Industrial

Technology &

Development

Center

Development

Center for

Biotechnology

Food

Industry

Research &

Development

Institute

Animal

Technology

Institute Taiwan

R&D scope Public health

New dosage

development

Clinical

Genomics

Nanobiotechnology

Pharmaceuticals

Tissue engineering

Pharmaceutical

dosage form

development

Preclinical trials

Biotechnology

and

pharmaceutical

production

Bacterial

collection,

examination,

and

Transgenic

animal-derived

pharmaceuticals

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trails and medical

engineering

for Chinese

herbal medicine

Production

processes for

Chinese herbal

medicine

processes

Pre-clinical

services

preservation

for the

improvement

of food

technology

Animal testing

Biochemistry

safety tests

Structural

engineering

Source: Biotech East, Biotechnology in Taiwan http://www.biotecheast.com/index.php

2) Approximate Investment Size and Main Investors

a) Present Situation of Biotechnology Clusters in Taiwan

Taiwan's science parks are part of a network of industrial parks set up over the years

to provide a supportive environment for the manufacturing industry, catering

particularly to export-based companies. These districts, some commissioned by the

central government, others by local city and county councils, some even by large

private industrial conglomerates, are situated away from existing residential areas but

close enough to supply needed labor and associated infrastructure, full set of

supportive industries, utilities, schools, etc.

Some parks were planned as (or have developed into) special purpose areas, such as

Hsinchu Science Park, while others are general purpose industrial zones.

The government has encouraged life science companies to locate in the island's

science parks, which have been designed especially for high-technology industries.

There are currently two in operation; the Hsinchu Science Park and Southern Taiwan

Science Park, with the Taichung Science Park still under development. Associated

with these science parks are zones catering specifically for life science companies

and Institutes, such as the Hsinchu Biomedical Science Park.

Taiwan's science parks are set up and administered by a special division of the

National Science Council (NSC).

Taiwan biotech industry is classified into three regions, "new biotechnology

(biological materials and agricultural biotechnology, etc.)", "pharmaceutical", and

"medical equipments." There are five agricultural bio-parks as industrial cluster of

agricultural biotechnology. "Changhua National Ornamental-Flower Park ", "Chiayi

Herb Medical-Herb Park", "Tainan Taiwan Orchid Floral Park", "Yilan Marine

Organism Park", "Pingtung Agricultural Park (Taiwan Green Bio-Park)", and there

bio-related companies and bio-venture are carrying out development and production

of the bio products.

It can be said that these bio-clusters are still more nearly developing because they

were built 2000s, considering from the number of companies and number of

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employee . The Taiwan government aims at development, making another cluster

based on the successful cluster, or taking in the management resources of the bio

cluster. As factor of these cluster growth, there are two; (i) collaboration of

supporting organizations and establishment of knowledge network, (ii) the financial

support system and incentive policy led by the government. In the bio-cluster, the

incubation center is considered the core of business creation. Many venture

businesses were created based on this, and the network of industrial, government and

academic sectors was organized. Although 70% was occupied with a pharmaceutical

in 2007, new medicines development, medical equipments, etc., in biotech industry

investment of Taiwan, growth rate of agricultural biotechnology is greatly expected

in the growth target of biotech industry. This development changes the state of

traditional agricultural ways and is expected to contribute also to a growth of

surrounding industries.

b) Outline of Main Biotechnology Clusters in Taiwan

(i) Hsinchu Science Park

Taiwan's first (established in 1980) and most well-developed science park, the

1100-hectare Hsinchu Science Park (HSP) is home to many of the island's largest

and most famous IT and semiconductor companies, including Taiwan

Semiconductor, the world's largest made-to-order IC manufacturer. To the north

and south of the park are two special biomedical zones.

To the north, the Hsinchu Biomedical Science Park, still being developed, will be

centered around the 600-bed National Taiwan University Medical Center. The

hospital will house a cancer research and proton therapy center. The park will also

house an incubation center, joint research centers, an information network center,

and a biotechnology center.

To the south, the Chunan Base, currently occupied by the National Health

Research Institutes (NHRI) and the Animal Technology Institute of Taiwan, is

also attracting biotech startups.

It is expected these two bases will develop into true biotech clusters, reinforcing

Hsinchu's position as a premier biotech hub.

Hsinchu Biomedical Science Park

A. Brief Introduction and Features

According to the successful examples of the overseas developmental process of

biomedical industry and biotechnology park, the developmental model for the

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establishment of biomedical science park cluster in Taiwan was integrated with

the concept of one-stop shop for biotechnology integrated incubation

mechanism, in order to develop the R&D potential of biomedical business.

Biomedical industry can also develop product with market value through the

verification of clinical trial platforms. Furthermore, the advantages over ICT

design and manufacturing of HSP can be integrated with biomedical industry at

the Park to trigger new development of biomedical technology in Taiwan, to put

into practice the development of knowledge economy by the government and to

enhance national competitiveness.

B. Management and Mission

I. Goals

-To make Taiwan become an important member of international biomedical

social groups and to introduce the one-stop shop concept of supra incubation

center (SIC) of biotechnology into Taiwan to make Taiwan become an

important link in Asia seeking for technological value adding and industrial

development

-To make the Park become an ideal base of innovative R&D/industrial

incubation for foreign and domestic biomedical field-related high-tech

talents

-To develop the Park into the pioneer leading the development of biomedical

industry in Taiwan

II. Strategies

-To aggressively construct infrastructure engineering and standardized

biotechnology plant to facilitate the businesses

-To aggressively create business opportunities and to attract investment

-To give priority to the promotion of establishment of Biomedical

Technology and Product R&D Center and Incubation Center to develop

medical devices and pharmaceuticals-related industries

-To establish relevant biomedical verification and testing platforms and to

develop a complete risk management system

III. Park Planning

The Park will introduce the mechanism of biotechnology SIC to plan the

construction of three major centers (―HBSP Hospital,‖ ―Biomedical

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Technology and Product Research Center‖ and ―Industrial and Incubation

Center‖). The interconnection and R&D resource sharing will be the

developmental focuses of the Park. Every requirement for the development

of biotechnology industry, such as R&D, trial preparation, clinical trial,

patent transfer and company incubation, will be integrated in the Park to

provide companies with one-stop shop support and legal verification

service to speed up the industrialization of R&D achievements. Moreover,

the Park will be integrated with HSP and the industrial advantage over ICT

to form a cluster effect, and becomes the pioneer leading the development

of biotechnology industry in Taiwan.

IV. Operation and Management

-Park Administration is responsible for the business recruitment

and operation of the Park

-The planning and construction of Incubation Center is led by

Ministry of Economic Affairs

-HBSP Hospital is planned by Department of Health

-Biomedical Technology and Product Research Center is planned and

operated by National Science Council

C. Park Public Facilities

Hsinchu Biomedical Science Park covers an area of approximately 38.1

hectares, and is located in the HSR Hsinchu Station Special District

(HSR Hsinchu Station Special District industrial area). The completed

construction of public infrastructures in the Park includes two major

parts, public facilities and overall landscape engineering:

I. Public Facilities Engineering Project

The public facilities engineering project includes the construction of required

service facilities, such as primary and secondary roads, underground parking

of the Central Park, reservoir, underground joint trench, sewage trench,

electronic monitoring system, etc.

II. Overall Landscape Engineering Project

The Overall Landscape Engineering Project includes site preparation, road

paving, vegetation planting and installation and construction of facilities

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such as landscape pond, various garden bridges, landscape restaurant, green

veranda, pavilion, and water stage. Moreover, the Park is equipped with

50KWp solar photovoltaic system. As for vegetation, arbors and shrubs are

planted in the Park. The project also includes the construction of sprinkler

system, indicator system, water and electricity engineering, and other

miscellaneous engineering.

III. Biotechnology Building

The construction of the standard biotechnology building of the Park has been

completed in February 2011 and is currently recruiting business and

investment.

D. Business Opportunities and Investment

Hsinchu Science Park is a high-tech cluster which enhances industrial

competitiveness and promotes economic development.

HBSP plays the role of integrating various resources, connecting the power of

industries with that of government, academia, research and medical field to fill

the gap of biomedical industrial chain. Moreover, the Park integrates the global

leading advantages of ICT industry at the HSP to encourage electronic

industries to invest capital and technology in cross-industry alliance and to

develop niche-based industries with innovation potential, such as industries

concerning ―R&D of new drugs‖ and ―advanced medical devices.‖ With the

advantages of the Park and the strong R&D foundation, the Park integrates

various relevant research resources to establish complete supporting measures

and mechanisms for industrial incubation to effectively reduce the cost of R&D

and industrialization cost and to increase the success rate of entrepreneurship of

biomedical corporations. Furthermore, the Park attracts the companies

conforming to its developmental objective and possessing international

competitiveness to start entrepreneurship at the Plant, in order to construct a

complete biomedical industrial cluster.

The government offers companies in the Park various ―incentives and

privileges‖ and a One-stop Service to provide the finest investment

environment in an aim to improve technological advancement of the

biomedical technology industry and make the Park one of the Asia's pioneer

developers of biomedical research in the 21st century.

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E. Innovative Services

Introducing the Innovative Services of the Hsinchu Biomedical Science Park,

to serve biomedical businesses in the Park, the Administration plans to

establish several information platforms, including the "International Standard

Technical Document Management System and Plan for Mechanism of

Cooperation in Clinical Trials of Medical Apparatus", "Planning and Initiation

of the Information System Integration Platform for Biomedical Research and

Development", "Planning and Establishment of the Medical Information

System" and "Planning and Establishment of the Biomedical Science Park

Portal". In addition to the above plans, the Administration also has several

plans for the future, including "Establishment of the Virtual Testing Laboratory

and Information Platform for Linking Models in Clinical Trials" and

"Establishment of Information System on Issuance of Patents and R&D

Consultation", which are intended to provide excellent information platforms

and services and help biomedical businesses shorten time to market from R&D

to production and in turn boost competitiveness.

F. Biomedical Industry Patent Inquiry Platform

In recent years, the management and flexible application of intellectual

property rights has become the most popular research issue. All of the foreign

and domestic high-tech corporations have attached importance to the strategies

for management of intellectual property rights and suggested that the

importance of intellectual property rights is closely related to corporate

development. According to the survey by World Intellectual Property

Organization, if the information on intellectual property rights of patents and

trademarks is used properly, the R&D time and R&D cost can be effectively

reduced by 60% and 40%, respectively.

In view of this trend, ―Biomedical Industry Patent Inquiry Platform‖ was

established as the window for information exchange of biomedical

industry-related patents. Moreover, it is hoped that the webpage of complete

guidance information on intellectual property rights can compensate the lack of

multidisciplinary talents in the fields of technique, patent, legal affairs and

management in corporations, and assist biomedical industry in Taiwan in

establishing intellectual property right management system to enhance R&D

capacity.

All of the services currently provided on the website are for free. The website

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contents include the introduction to patent system and cases, information on

patent activities, patent consulting service yellow page, patent news,

patent-related website links, patent Q&A, discussion board, etc. The domestic

biomedical companies and their employees may access to patent consulting

service via phone and may also consult with patent professionals in detail and

face-to-face by making an appointment.

G. Service Contents of Inquiry Database of Organizations

HBSP Office has established ―Inquiry Database of Examination Organizations,

Laboratories and CROs‖ to provide inquiry service of ―examination/laboratory

organizations‖ and ―CROs‖ for biomedical products, in order to speed up the

function testing and clinical trial of biomedical products and to reduce the time

for product marketing.

In terms of ―examination/laboratory organizations,‖ their objective is to

provide the information on safety and efficacy as required by pre-marketing

biomedical products. Moreover, the capacity of various examination/laboratory

organizations in Taiwan will be compared in order to establish the validation

environment of biomedical product-related laboratories in Taiwan. The

establishment of such validation environment can assist HBSP in integrating

the knowledge supply chain of validation testing for various bridging studies at

laboratories to speed up the marketing of new medical and biomedical

devices/products.

As for ―CROs,‖ their objective is to summarize the information on clinical

trials conducted at hospitals, to complete the connecting and cooperative

development model of clinical trials and to attract sponsors to conduct clinical

trials in Taiwan.

H. Investment Information

I. Water, Electricity and Environmentally-Friendly Facilities

The total power supply is 29,330 KW and the total water supply is 6,385

CMD. The total sewage capacity is 4,990 CMD. Laboratories under P3 level

are allowed to be set up in the Park.

II. Management Fee

A management fee of 0.19% of the turnover shall be charged. A minimum

management fee of NTD (New Taiwan Dollar) 10,000 shall be charged.

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III. Biotechnology Building

Biotechnology Building is open for rent. It offers a total of 36 units as the

actual operating area, including 6 units of 55 ping (16.6375 m2) operating

area, 10 units of 100 ping (30.25 m2) operating area and 20 units of 200 ping

(60.5 m2) operating area.

IV. Monthly Rent

Land rent at approx. NTD 59/m2 per month

Biotechnology Building rent at approx. NTD 109/m2 per month

V. Investment Margin

0.3% of the total investment capital shall be charged as the investment

margin and shall be refunded without interest upon completion of the

investment project.

VI. Electricity Fee

Approx. NTD 1.22-4.26 per unit (subject to electricity consumption, voltage

in use and time of electricity used).

VII. Water Fee

Approx. NTD 7-11 per unit (subject to water consumption); NTD 11.5 per

unit shall be charged for users whose total water consumption reaches 50

units (tons) and above.

VIII. Sewer User Fee

It shall be charged according to sewage quality and amount of sewage.

Note: The rent rates of the Park are temporary estimates. The actual rent rates

will be announced upon completion of the sharing of public facilities.

Moreover, the rent rates may be adjusted year by year according to the

announced land values, construction fee of public facilities and applicable

laws and decrees.

I. Appearance and Floor Plan of Biotechnology Building

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Source: Hsinchu Biomedical Science Park HP

Figure 2.1.36 Appearance of Biotechnology Building

Source: Hsinchu Biomedical Science Park HP

Figure 2.1.37 Exterior and the Surrounding Environment of Biotechnology Building

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Source: Hsinchu Biomedical Science Park HP

Figure 2.1.38 Interior of Biotechnology Building

Source: Hsinchu Biomedical Science Park HP

Figure 2.1.39 Floor Plan of 2F-5F of Biotechnology Building

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Source: Hsinchu Biomedical Science Park HP

Figure 2.1.40 Plant Space (the actual operating area of 200 ping [60.5 m2] for example)

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(ii) Southern Taiwan Science Park (STSP)

With the success of the Hsinchu Park, plans were made to extend Taiwan's

high-tech development to the south of the island. The Southern Taiwan Science

Park is the result of this planning, and is located between the southern cities of

Tainan and Kaohsiung.

The first-stage Tainan Science Park started operations in 1996. Originally planned

as an agricultural biotech center, its 1038-hectare location was chosen because of

its proximity to agricultural research Institutes, including National Cheng Kung

University, National Sun Yat-Sen University, the World Vegetable Center, Taiwan

Livestock Research Institute, and the Tung Kang Marine Laboratory.

While such an agricultural emphasis is still hoped for, today the major industries

in the park are the same as those in the Hsinchu park, namely IT and electronics

companies. The most significant life science company with facilities in STSP is

ScinoPharm Taiwan Co., Ltd. However, with vast land resources available,

government incentives and location advantages on offer, the park will certainly

play a major role in Taiwan's future biotechnology development.

As of late 2003, 116 companies had set up operations at the park, with 24 of them

being biotech companies.

The second stage of the park, the Luchu Science Park, opened in 2001 on land

provided by state-owned Taiwan Sugar. The 571-hectare park consists not only of

industrial sites but also residential areas, public facilities and wildlife reserves.

(iii) Biotechnology Plaza, Nankang Software Park

Opened in 2003, the Biotechnology Plaza is part of the newly-developed Nankang

Software Park, located east of Taipei. This park is home to many software

development companies and other high-tech enterprises. Biotechnology Plaza is a

20-floor building with a total area of 72,600 square meters, and the first

R&D-focused biotech center in Taiwan. This state-of-the-art facility is ideally

situated near R&D resources and institutes such as Academia Sinica, the

Development Center for Biotechnology (DCB) Hsichih facilities, and the many

major medical centers in nearby Taipei City. In addition, leading research

institutes such as Academia Sinica, the DCB and the National Health Research

Institutes (NHRI) will have a presence in the park. Government institutes

including the National Science Council and the Biotechnology & Pharmaceutical

Industries Program (BPIPO) of the MOEA will also have administrative offices at

this location.

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(iv) Other Biotech-Focused Biocluster and Industrial Areas

Table 2.1.19 Bioclusters in Taiwan

Region Main Field Location

Area

Major Universities

and Institutes

Major Enterprise and

Venture

History of

Development

Taiwan Green

Bio Park

High Level

Agro-bio

Pingtung

Pref.

233ha

Fishery Institute,

Improvement of

Seeds, Forestry

Institute,

Pingtung University

Bio Agriculture,

Medicines, Bio

Fertilizer, Vaccine,

Functional Foods. 150

companies involved

Agricultural

Biotechnology

Park started in

2003

Medical-Herb

Bioscience

Technical Park

Herbal Bio

Food

Production

Chiayi

Pref.

6.14ha

Taiwan Orchid

Flower

Science Park

Development

Orchid

Marketing

Research

Tainan

25.8ha

29companies

Source: ―International Trade and Investment‖ No.56, 2004

The Neihu District of east Taipei is the site of a newly-developed industrial area

and home to many biotech companies.

Taiwan's pharmaceutical manufacturing industry, although spread across the

island, is concentrated primarily in Tainan County's many industrial parks and to a

lesser degree in the following areas: Taipei County, Taoyuan County, Hsinchu

County, Taichung County, Nantou County, Chunghwa County and Kaohsiung

County.

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(5) India

1) Purpose and Background for Cluster Location

a) Overview and Short History of Biotechnology in India

The Indian Biotechnology industry has been evolving over three decades. The

milestones of the evolution of biotech industry in India began in 1978, in Bangalore,

when the country‘s first biotech company Biocon was established for producing

industrial enzymes. The Government provided a major thrust to the sector with the

establishment of the National Biotechnology Board (NBTB) under the aegis of the

Department of Science and Technology (DST) in 1982. The NBTB acted as an apex

body, which was given the task of identifying priority areas and evolving a long-term

plan for the development of biotechnology. Four years later in 1986, the NBTB was

upgraded to a full-fledged Department of Biotechnology (DBT). This paved the way

for furthering the growth of biotechnology in the country.

The progress for biotechnology industry in India has been possible due to the

inherent advantages that the country has, including diverse flora and fauna, large

gene pool, temperate climate, quality manpower and low-operational costs. Further,

the proactive policies and measures taken by the Government of India and its

agencies, have allowed the industry to capitalize upon such advantages. Today,

biotechnology is being promoted in the country keeping in view its enormous

potential to improve agriculture, food, health, environment and energy requirements

of the population.

b) Outline of Biotech Sector in India

In terms of market dynamics, the Indian biotech sector had a healthy growth in

2012-13 with its revenues reaching Rs. 235.24 billion. Within this, BioPharma

contributed Rs. (India Rupee) 149.23 billion, followed by BioServices (Rs. 43.29

billion), BioAgriculture (Rs. 32.10 billion), BioIndustrial segment (Rs. 7.72 billion),

and BioInformatics (Rs. 2.90 billion). Recent trends in turnover of the industry

indicate that the Indian biotechnology industry recorded a CAGR (Compound

Annual Growth Rate) of 14.15% during the last five years, increasing from Rs.102.72

billion to Rs. 235.24 billion during the period.

The domestic biotechnology market clocked revenues of Rs 115.12 billion in

2012-13, registering a 8.6% growth as compared to the previous year, and accounting

for around 48.9% of revenues generated in the industry.

As regards segment-wise data, for the year 2012-13, BioPharmaceutical sector

accounted for the largest chunk of the biotech industry, garnering a share of 63.4% in

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total revenues, with vaccines being the largest contributor within the

BioPharmaceutical segment.

BioServices (18.4%) and BioAgri (13.6%) are other major sub segments of Indian

biotech industry.

Segments like BioIndustrial and BioInformatics garnered a share of 3.3% and 1.2%,

respectively of the total revenue in 2012-13.

The Indian biotech industry is largely export-driven accounting for 51.1% of the total

revenues in 2012-13. In rupee terms, the exports business went up by almost 22.5%

to Rs. 120.12 billion.

c) National Biotechnology Development Strategy

Government of India on its part has initiated certain far-reaching legislations to

promote the growth of the biotechnology industry in the country. In India, there is

involvement of several organizations regulating the development of biotechnology,

which has often resulted in overlap of functions. In order to streamline the regulatory

process, the Government has proposed the establishment of the National

Biotechnology Regulatory Authority (NBRA), to provide a consistent mechanism for

regulatory approval. The National Biotechnology Regulatory Authority would be set

up as an independent, autonomous and professionally led body to provide a single

window mechanism for biosafety clearance of genetically modified products and

processes. In July 2008, The Department of Biotechnology (DBT) introduced the

National Biotechnology Regulatory Act, which empowered the NBRA as an body to

approve genetically modified crops, food, recombinant biologics like DNA, vaccines,

recombinant gene therapy products, and recombinant and transgenic plasma-derived

products such as clotting factors, veterinary biologics and industrial products.

The key elements of the Indian National Biotechnology Development Strategy are as

follows:

•High-powered Inter-ministerial Committee is to be set up under the chairmanship of

secretary, DBT, to effectively coordinate the development of the sector by

addressing cross cutting issues.

•30 percent of DBT's Budget to be spent on public-private partnership programs.

•Biotechnology Industry Partnership Program (BIPP) for Advanced Technology

would be launched

•The existing Small Business Innovation Research Industry (SBIRI) scheme to

promote innovation in SMEs has been a success. Approval has been accorded for

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the expansion of SBIRI during the 11th Plan.

•Biotechnology Industry Research Assistance Council (BIRAC) is to be launched to

act as an interface between academic and private sector, particularly SMEs and

startups; nurture and catalyze R&D and innovation in biotechnology in the private

sector and promote public-private partnerships.

•A new role visualized for autonomous institutions of DBT to promote excellence in

R&D. Selected institutions will be financially empowered for promoting excellence

in and translational R&D by supporting 'Research Resource Units' in universities

and sister institutions through extramural funding.

•UNESO Regional Centre for Science, Education and Innovation in Biotechnology

being established at Faridabad, Haryana, by DBT as part of a Health Science and

Technology Cluster.

•Innovative re-entry packages in terms of fellowships and R&D support will be

offered to young and senior scientists of Indian origin to return to Indian

laboratories and pursue research on national priorities.

•In order to create and strengthen world class institutional research capacity in

biotechnology, 50 Centers of Excellence (CoEs) to be established during the 11th

plan

•Keeping in view the requirements for translating scientific leads into useful

products and processes, a new national initiative will be taken up to build capacity

in technology transfer and intellectual property rights.

•Cluster development is a key strategy to promote innovation and accelerated

technology and product development. This new approach has been given the green

signal by the government. Four technology clusters are at an advanced stage of

planning.

•Grand challenges of national relevance in the area of agriculture, health, energy and

environment will be identified through national and international consultations.

Programs will then be launched through multidisciplinary teams, involving

public-private partnerships.

•DBT's proposal to establish new institutional structures, especially in areas very

vital to India's progress but in which current strengths are suboptimal has been

approved in principle by the government. The institutions, representing a new

breed, will be designed with a strong bias for integrating science and translation,

and for producing skilled personnel driven towards entrepreneurship.

In its vision to build world class human capital, the strategy has focused on:

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•Improved and expanded PhD and post-doctoral programs in order to reach the best

levels in the Asian region

•Enhanced quality of masters level and undergraduate level education

•Promotion of life sciences and biotechnology at undergraduate and masters levels

•Creation of a translational workforce of high quality to meet short- and mid-term

requirements of the country

•Promoting support to institutions for undergraduate education to achieve 'Star

College' status.

The enactment of New Patents Act, 2005, brought a paradigm shift in research and

development in the sector. Previously, India had a patent protection for process rather

than the product, which brought about complacency without initiating much effort

upon the development of new products. The New Patents Act of 2005 enforces

product patents thereby inspiring firms and research institutions to undertake the

innovation at their behest. Apart from this, there are two bills, namely, DNA Profiling

Bill, and The Protection and Utilization of Public Funded Intellectual Property Bill,

which are on the anvil and are expected to be passed by the Parliament shortly.

d) Government Funding

In addition to creating enabling policies, the Government has also been supporting

the sector through provision of funds. While Government funding to the Science &

Technology sector increased nearly three times from the Tenth Five-Year Plan to the

Eleventh Five-Year Plan, support to the biotech industry increased by as much as four

times during the same period with the budgetary allocation shooting up from Rs.

253.0 billion in the Tenth Plan to Rs. 753.0 billion in the Eleventh Plan. In fact, the

Department of Biotechnology received almost 8.5% (Rs. 63.9 billion) of the total

budgetary outlay of the Ministry of Science & Technology in the Eleventh Plan.

Though the DBT remains the main funding organization for the Biotech sector in

India, there are other scientific departments, which have also started contributing in

this field.

e) Research & Development Facilitation

The DBT and other organizations have also proactively taken up a number of

initiatives in creating institutional infrastructure and a strong research base in the

country in areas relating to agriculture and forestry, human health, animal

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productivity, environmental safety and industrial production.

DBT has also been at the forefront of maintaining many international collaborations

and introducing joint proposals with countries like Australia, Canada, Finland,

Germany, Sweden, USA, Japan and the EU. Under the National Bioresource

Development Board, a major initiative has been taken for the establishment of a

Microbial Culture Collection–Biological Research Centre in Pune.

The Centre has provision to hold more than 200,000 bacteria and fungi following

international standards, with the gradual upgradation of the facility as an

International Depository Authority on microbial collections. Under the program on

prospecting of drugs from microbial sources, about 100 thousand bacterial isolates

have been collected and screened. More than 200 thousand extracts have been

prepared, and about 7,000 promising hits obtained.

f) Centers of Excellence in Biotechnology Sector in India

The Department of Biotechnology (DBT) has set up numerous topnotch Centres of

Excellence (COE) in the country. These centers are responsible for generating skilled

manpower as well as supporting R&D efforts of corporates. These institutions have

also been enhancing interactions between the academia and the industry. Eleven such

COEs are under implementation in the areas of genome sciences and predictive

medicine; system biology and tuberculosis; genome-mapping and molecular

breeding of Brassicas, Stem Cell research, Anti-virals etc. It is envisaged to fund 50

COEs mostly in Universities during Eleventh Plan.

Representative centers of excellence in biotechnology sector in India are shown in

Table 2.1.20.

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Table 2.1.20 Representative Centers of Excellence in Biotechnology Sector in India

Advanced Basic Research

-Tuberculosis Drug Resistance

(Indian Institute of Science, Bangalore; The Foundation of Medical Research, Mumbai; Birla

Institute of Technology & Science, Pilani)

-Designing inhibitors against infectious agents

(National Institute of Immunology, New Delhi)

-Basic Molecular biology of a model microorganism, E.coli

(Centre for DNA Fingerprinting and Diagnostics, Hyderabad)

Advanced Science with Translational Research

-Systems Biology of Tuberculosis and Drug Development

(International Centre for Genetic Engineering and Biotechnology, New Delhi; University of

Delhi, South Campus, New Delhi; Central Research Institute of Jute & Allied Fibres,

Barrackpore, W.B)

-Genetics and Genomics of Silkmoths

(Centre for DNA Fingerprinting and Diagnostics, Hyderabad)

-Antivirals Against Hepatitis C

(Indian Institute of Science, Bangalore & others)

-Mesenchymal and Adult Stem Cell Therapies

(Christian Medical College, Vellore)

-Platform Technologies for Designer Crops

(International Crop Research Institute for the Semiarid Tropics, Hyderabad)

-Stem Cell Research: Basic and Translational

(All India Institute of Medical Sciences, New Delhi)

Partnership with Industry

-Heterosis Breeding in Rice

(University of Delhi-South Campus, New Delhi & Mahyco Ltd., Jalna)

-DBT-University Institute of Chemical Technology

(Energy Biosciences Centre), Mumbai

Source: Department of Biotechnology, Government of India, Annual Report

g) Public-Private Partnerships

Public-private partnership needs to be encouraged and supported in areas that are

vital to national development, from a scientific, economic or social perspective. The

focus needs to be on technology and product development. India has a wide network

of universities, departments and specialized institutes that have been promoted by

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various authorities providing numerous specialized science degrees at the Masters‘

level.

These institutions also provide an effective network of research laboratories. Efforts

should be made to bring in a seamless transfer of knowledge and people among these

universities, institutes, and corporates for better coordination, and to share their

research-based information on an ongoing basis. Corporates could have preferential

access to the intellectual property generated in such jointly funded projects.

Another alternative could be encouraging public-funded successful R&D institutions

to establish ‗not for profit‘ companies to facilitate collaborative work with industry.

There should be an industry-academia alliance wherein the industry could have an

active participation when it comes to planning curriculum and methods of evaluation.

Private firms may also share the responsibility to promote academic excellence by

creating Chairs in Universities and further strengthen the industry – academia

relationship.

h) Fostering Growth Through Bio Clusters

The Indian biotechnology industry is spread across many states in the country. These

states have unveiled state-specific biotech policies and have established biotech

parks to attract investment in this industry. These parks have emerged as a focal point

of some of the leading biotech clusters such as Genome Valley in Hyderabad and

Hinjewadi in Pune. The respective government policies in these states and scientific

ambiences have also been responsible for the growth of bioclusters.

The state governments are contributing their bit towards developing the

biotechnology industry in cities having strength and potential but there are a few

missing elements. Once everything is in place, with the coordinated efforts of all

industry stakeholders, India will have many bioclusters.

The United Nations Industrial Development Organization (UNIDO) has identified

about 388 clusters in India in various sectors from textile to chemicals and

pharmaceuticals to food processing. Of these 11 clusters are situated at Cuttack in

Orissa, Hyderabad in Andhra Pradesh, Indore in Madhya Pradesh, Thane, Pune,

Aurangabad and Mumbai in Maharashtra, Margao in Goa, Valsad/Bharuch, Baroda

and Ahmedabad in Gujarat, all dedicated to pharmaceuticals. These clusters are into

bulk/ basic drugs manufacturing.

The Minnesota Biomedical and Bioscience Network has prepared a list of the life

sciences and biotechnology clusters of the world in which it has included Bangalore,

Hyderabad and New Delhi as clusters along with New York/New Jersey, Philadelphia,

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Baltimore/Washington, DC, Research Triangle NC of the US.

Clusters are particularly important in knowledge-based sectors like biotechnology,

medical biosciences, life sciences, and information technology, despite the trend

towards globalization arising from rapid advances in transport and communication

and accessible global markets. This is because the type of knowledge that creates

competitive advantage often requires proximity or regular face-to-face interactions

and trust in order to be effectively communicated.

Earlier studies and analysis demonstrate that clusters can raise innovation and

productivity in a number of ways. Companies benefit from sharing knowledge about

best practice and reduce costs by jointly sourcing services and suppliers. Frequent

interactions facilitate formal and informal knowledge transfer and encourage the

formation and efficiency of collaboration between institutions with complementary

assets and skills. The critical mass effect attracts further companies, investors,

services, and suppliers into the cluster, as well as creating a pool of skilled labor.

Local training institutions and infrastructure can provide further benefits for

companies. Rivalry between firms can stimulate competitiveness and encourage

constant upgrading. Many of these benefits are likely to be more important for SMEs

than for larger companies that are more able to capture them internally.

The concept of clustering definitely has relevance for the Indian biotechnology

industry, which has just started moving up the growth ladder.

Rajesh Jain, joint managing director, Panacea Biotec said, "Bioclusters would work

in India. Such bioclusters will be successful, provided a close interdisciplinary

strategy is adopted by cohesive interactions between excellent innovative science and

entrepreneur spirit of business leaders and industry friendly policy of the government.

The success of bioclusters will not only result in improving the economic

development of the country or marking India a global "hub" of biotechnology, it will

also generate excellent job opportunities."

Sharing similar views, Vibhav Garg, principal-business development, Mascon Life

Sciences said, "Bioclustering is a good way of looking at the scattered expertise and

experience, which could be complementary to each other, under one roof. This

approach is already bearing fruits for rest of the world. I do not see any reason why it

will not work in India. The approach is certainly going to benefit the industry and the

country as complementary nature of the organizations in a given biocluster will bear

fruits for all and hence it will be a win-win for one and all."

Rajesh Jain further said, "Bioclusters in terms of development of biotechnology

industry have already grown unintentionally as clusters. These clusters are mainly

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located in the states of Andhra Pradesh, Maharashtra, Karnataka and Delhi. The

respective government policies and scientific ambiences have been responsible for

the growth of such clusters. A recent example is a cluster of biotechnology and

pharmaceutical ventures at Baddi in Himachal Pradesh."

Main life biotechnology and life science clusters in India are shown in Figure 2.1.41.

Note: Green areas represent life biotechnology and life science clusters

Source: BioSpectrum India

Figure 2.1.41 Indian Bioclusters

2) Approximate Investment Size and Main Investors

There have been a lot of activities in public/private partnerships for biotech parks in India.

Overall, India is still strong in generics, but some innovative companies are coming out of

Genome Valley, about 20 miles from Hyderabad, and also from Bangalore. Within the

next two to three years, India expects to have about 27 biotech parks, according to Ernst

& Young.

a) Key Biotech Clusters in India

Bangalore, in Karnataka is the Biotech capital for India. India houses 380 biotech

companies of which a majority of 198 are in Karnataka and 191 in Bangalore alone.

Bangalore and Karnataka jointly contribute 27% to the revenue of the sector.

The other key clusters include Mumbai and Ahmedabad in the West (Maharashtra

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and Gujarat respectively), Hyderabad (Andhra Pradesh) in the South and the area in

and around New Delhi in the North.

The Western belt houses companies that are large pharmaceuticals with a prominent

manufacturing and R&D base, who have active interest in pursuing the manufacture

of biogenerics.

Hyderabad has several vaccine manufacturers and other large biotech companies

involved in research. The regions in and around New Delhi house several key

research centers and universities that are involved in research.

(i) Karnataka - Bangalore

Biotechnology, post the ICT success, has emerged as a recent rapidly expanding

sector in Bangalore. The city accounts for over 50% of the 380 biotech companies

in India. The city has revenue of over $550 for 2008-2009 which is over 20% of

the total biotech revenue for the country.

Bangalore is the country‘s largest cluster, the city boasts of 198 biotech firms.

Biocon, the nation‘s leading biotech company is headquartered in Bangalore.

Some of the key life science companies to look out for in Bangalore include:

Advinus Therapeutics, Astra Zeneca, Aurigene Discovery services, Biocon India,

Jubilant Biosys, Metahelix Life Sciences, Strand Life Sciences, Strides Arcolab

and Xcyton Diagnostics

Government of Karnataka is investing Rs. 5,500 crore in Bangalore Helix Biotech

park which is spread over 106 acres at the Electronics City, off Hosur Road in

Bangalore.

Bangalore can boast of good Universities like the Indian Institute of Science,

JNCASR, NCBS, University of Agricultural Sciences. ABLE the Trade

association for Biotech Industry is headquartered at Bangalore.

Bangalore has opportunities in Contract Research Space and lot of potential in the

Stem Cell area.

(ii) Andhra Pradesh - Hyderabad

Biotechnology is an important industry in Andhra Pradesh. There is a high

concentration of biotech companies producing recombinant therapeutics for

human consumption. It also has the second largest recombinant DNA therapeutic

production facility in the world, which is also being used by multi-national

companies to produce their own recombinant products. Andhra Pradesh is called

―Bulk drug Capital of India‖. Andhra Pradesh has a dominant position in the bulk

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drugs and pharmaceutical sector with Hyderabad accounting for nearly one third

of India's total bulk drug production. Hyderabad has witnessed infrastructural

development in the biotech domain wherein the Knowledge Park, the Biotech

Park, Genome Valley and other projects have come up giving the city an

advantage over others. Hyderabad is also a house for research and development

centers like Centre for Cellular and Molecular Biology (CCMB), Indian Institute

of Chemical Technology (IICT), International Crop Research Institute for

Semi-arid Tropics (ICRISAT),Central Food Technology Research Institute

(CFTRI) and Institute for Life sciences centre is based out of Hyderabad and have

32 laboratories and 12 research centres.

The Government of Andhra Pradesh offers opportunities in Therapeutics,

Diagnostics, Industrial Biotechnology, Inputs to the industry (hardware suppliers

- Instrumentation and Chemicals), Agricultural Biotechnology in the biotech

space.

(iii) Tamil Nadu - Chennai

Tamil Nadu is the first state to have introduced a separate Bio Tech policy. Tamil

Nadu presents an attractive market for medical biotechnology products as it

accounts for about 11% of the pharmaceutical market in the country. The

Government of Tamil Nadu has also announced the establishment of

Biotechnology Enterprise Zones (Bio-Valleys) along the lines of Silicon Valley to

exploit the bioresources of the State. Chennai has some of the top pharma

companies like Orchid Pharma, Shasun Pharma and Bafna Pharmaceuticals and

few Biotech companies like ABL Biotech and Proalgen Biotech. Tamil Nadu also

has reasearch centres like Centre for Biotechnology, Anna University Centre for

Plant Molecular Biology, Tamil Nadu Agricultural University, Coimbatore,

Centre for Research in Medical Entomology, Madurai, Department of

Biotechnology, School of Bioengineering, SRM University, Rajiv Gandhi Centre

for Biotechnology, School of Biotechnology, Madurai Kamaraj University,

School of Chemical and Biotechnology – Sastra University. Tamil Nadu has

opportunities in the area of Stemcell Research and Nanotechnology.

(iv) Maharashtra - Western Region

The state accounts for 40 per cent of the country' pharmaceuticals output. It has

strong research capabilities and accounts for over 30 per cent of country‗s patents.

It has a presence of reputed companies focusing on the biotech sector including

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Wockhardt, Nicholas Piramal, Cipla and Lupin, among others and state is setting

up biotech parks at Hinjewadi, near Pune. Major opportunities have emerged in

the pharmaceutical sector, primarily in the areas of contract research, contract

manufacturing and clinical trials. State boasts of Low costs, strong manufacturing

base, well developed laboratory and R&D infrastructure, a strong resource pool.

The backward linkages with the well-developed chemicals and petrochemicals

sector is an added advantage.

(v) Gujarat

Gujarat accounts for around 30 per cent of national pharmaceutical production.

First state to manufacture APIs and finished dosage forms. It is a home to 902

allopathic manufacturing units and 2,122 contract manufacturing units. Gujarat

accounts for exports worth more than US$ 1.5 billion. It has number of clinical

research organisations in India and over 100 companies with WHO-compliant

manufacturing units, academic and research institutions providing over 4,600

technically-skilled manpower per annum. India‘s largest biotech park of 700 acres

is being developed in Savli, Vadodara. Key players are Zydus Cadila, Torrent

Pharma, Sun Pharma, Intas Pharma, Alembic, Dishman Pharma. Mumbai is home

to the two major pharmaceutical associations including Indian Drug

Manufacturers Association (IDMA) and organisation of Pharmaceutical

Producers of India (OPPI).

b) Outline of Main Biotech Parks in India

ICICI Knowledge Park was founded in 2000 on 200 acres of land. It currently is

100% occupied, with 80,000 square feet of wet labs and about 1,400 employees

onsite, according to the just released Ernst & Young study, ―Biotechnology Clusters

in India‖. Genome Valley also includes the Shapoorji Pallonji Biotech Park with

modular wet labs, pilot plants, a business incubation center, and business support

facilities. Its 140acre phase I site is operational, and the phase II site is expected to be

completed by 2015.

Hyderabad is dominated by the generics industry but has some biotech companies

that are working on innovative drugs. CROs, including GVK Biosciences, are

growing, spanning the gap between discovery and development. Strengths include

the University of Hyderabad, which has a strong private partnership culture.

Table 2.1.21 shows outline of main biotech parks in India.

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Table 2.1.21 Main Biotech Parks in India

Name of the Park Area

(Acres)

No. of Companies Specialization

Shapoorji Pallonji Biotech

Park, Hyderabad

300 16 companies in Phase 1

and 10 companies in

Phase 2

Life Science, healthcare

and pharmaceutical

ICICI Knowledge Park,

Hyderabad

200 35 R&D companies Life Science

Agri Science Park,

Hyderabad

25 108 ventures have already

been incubated

Agribiotech and

agribusiness R&D

Bangalore Helix, Bangalore 14 8 biotech incubators Sector specific SEZ

Biotech Park

Biotech Park, Lucknow 8 15 enterprises Healthcare, agriculture,

environment, industrial

application and energy

Kinfra Biotech Park, Cochin 50 Expected to house 15-20

biotech units with shared

facilities like biotech

incubation center

Bioinformatics and

biotechnology with focus

on marine, herbal and

agricultural biotechnology

Kinfra Biotech Park,

Thiruvanthapuram

25 Developing Stage Agriculture, healthcare,

diagnostic and industrial

enzymes

Golden Jubilee Biotech Park

for Women Society,

Kanchipuram

20 10 enterprises Agro, food and nutrition,

medical, and healthcare

and environment & energy

Inspira Infrastructure

Biotech Park, Aurangabad

25 Developing Stage This biotech park is

designed for bipharma and

agri-biotech companies

who are into

manufacturing and R&D

International Biotech Park,

Pune

100 12 enterprises Medical and Pharma

Biotechnology

Savli Biotech Park,

Vadodara

724 11 companies have been

recommended for land

allotment in Phase 1

All major sectors of

Biotechnology

TICEL Bio Park, Chennai 5 12 enterprises Medical Biotechnology,

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nutraceuticals, agricultural

biotechnology and

bioinformatics

Agri Biotechnology Park,

Jalna

124 n.a. n.a.

Source: Department of Biotechnology, Government of India, Annual Report

c) Plans of Each Biotech Park in India

(i) TICEL Bio Park

A. Outline of TICEL Bio Park

TICEL Bio Park, located in Chennai, India, provides world class laboratory

infrastructure and services for Biotech R&D. TICEL Bio Park Ltd. is a unit of

Tamil Nadu Industrial Development Corporation Ltd. (TIDCO), which is

undertaken by the State Government.

The Bio Park provides such facilities as (i) Bio Resource Centre (Under

Consideration), (ii) Tenancy Area and (iii) Training Center.

The Bio Park has proposed to undertake (i) Testing, analytical and mentoring

services at the Bio Resource Center, (ii) Training and (iii) Contract Research

Program.

The Government of Tamil Nadu has conferred the status of Research and

Development institution to TICEL. TNEB has extended to TICEL the Power

tariff applicable to R&D institution to promote growth of Biotechnology R&D

in Tamil Nadu.

B. Park Features

TICEL Bio Park, a world class infrastructure for biotech R&D, implemented in

5 acres of land in Chennai at a capital outlay of Rs.625 million (US$ 12.5

million) has now achieved 100% occupancy with National and International

clients.

Support and financial assistance (equity/term loan) was provided by TIDCO,

TIDEL, Indian Bank, Karur Vysya Bank and Indian Overseas Bank.

The Bio Park has proposed to offer the following facilities:

I. Bio Resource Center

Wet labs for Fermentation & Microbiology, Downstream Processing,

Molecular Biology, Plant Tissue Culture, Animal Tissue Culture and

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Analysis

II. Tenancy Area

The tenancy area has 74 modules of 1,525 sq.ft. each, available for clients to

develop their own customized R&D labs of BSL2 standards, upgradeable to

BSL3, in accordance with GLP standards. Clients can install their facilities

appropriate to perform their independent research and development

activities.

Source: TICEL Bio Park HP

Figure 2.1.42 Facilities in the Park

C. Park Infrastructure

Main park infrastructure of the park is explained as follows:

- World class design for Bio Park

- World class laboratory standards with BSL2 upgradeable to BSL3

Source: TICEL Bio Park HP

Figure 2.1.43 Appearance of the Main Building

- Common infrastructure and facilities

- Electrical power supply and distribution through two feeders

- 100% power backup

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- Air-conditioning with 100% fresh filtered air

- Water treatment and supply

- Waste water treatment & disposal - approved by Tamil Nadu Pollution

Control Board

- Consent from TNPCB under AIR (P & CP) & WATER (P &CP) Acts.

- Potable water, Compressed air and Vacuum

- Smart card access and security system

Source: TICEL Bio Park HP

Figure 2.1.44 Interior in the Park

D. Park Amenities

I. Business Center

-Four Cubicles with Computer available to facilitate tenants to set up their

offices at TICEL during prefitment period, at a rental of Rs.5,000/- plus

applicable service tax

-Two rooms attached with space for receiving visitors and for conducting

meeting can be availed on lease basis for three months

II. Training Center

-TICEL is equipped with modular training centre with two halls with seating

capacity of 60 persons each or single hall of maximum seating capacity of

120

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Table 2.1.22 Fees for Use of the Hall

(Rs.)

No. Module Duration Revised Rates

(TICEL Clients)

Other than

TICEL Clients

01 Full Hall Full Day (10 hrs.) 10,000 20,000

02 Full Hall Half Day (5 hrs.) 6,000 12,000

03 Half Hall Full Day (10 hrs.) 6,000 12,000

04 Half Hall Half Day (5 hrs.) 3,000 6,000

05 Full Hall 3 hours 4,000 8,000

06 Half Hall 3 hours 2,000 4,000

Note: Service Tax will be charged extra at 12.36% on the above rates;

Full Hall = 120 Seats ; Half Hall = 60 Seats

Source: TICEL Bio Park, Homepage

III. Other Amenities

-International standard communication facilities: Through Bharath Sanchar

Nigam Ltd (BSNL)/ Reliance Infocom Ltd (RIL)

-Food Court / Ample Parking area

-Access to Recreation facilities at TIDEL include swimming, Tennis and

Gymnasium

-ATM facility

E. Location and Surroundings

The Bio Park is located in the knowledge corridor where leading IT firms and

institutions of High tech research are situated and in the neighborhood of

residential areas.

Located just about 14 km from International Airport and 16 km from Chennai

Sea Port.

The Park is located in proximity to:

-Indian Institute of Technology (IIT)

-Anna University

-Madras University Institute for Basic Medical Sciences

-CSIR Labs of Government of India

-IT corridor with TIDEL Park and global IT firms

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F. Floor Plans

TICEL provides Laboratory space of BSL2/BSL3 standards for Biotech R&D

in modules of 915 sq. ft. with super builtup area of 1525 sq. ft.

TICEL provides the furnished lab space at the ground floor for long term lease

of 10 years with upfront collection of rent for the lease period.

Table 2.1.23 shows the floor plans for each floor.

Table 2.1.23 Floor Plans for Each Floor

Floor Lobs for rent/sale Number of Modules

G Furnished Wet Labs 13

1 Wet Labs 10

2 Wet Labs 16

3 Wet Labs 16

4 Wet/Dry labs 16

5 Wet/Dry labs 16

Source: TICEL Bio Park, Homepage

Source: TICEL Bio Park HP

Figure 2.1.45 Floor Plan (Ground Floor)

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Source: TICEL Bio Park HP

Figure 2.1.46 Floor Plan (First and Second Floor)

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Source: TICEL Bio Park HP

Figure 2.1.47 Floor Plan (Third and Fourth Floor)

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Source: TICEL Bio Park HP

Figure 2.1.48 Floor Plan (Fifth Floor)

G. Tenancy Rates

Government of Tamil Nadu has recognized TICEL as a Research &

Development (R&D) institution and hence TNEB provides electric power at

concessional tariff.

TICEL reduced the Tenancy/Rental advance for lab space to six month rental

charges and provides 3 month rent free-fit out period to furnish the labs by

clients.

Laboratory space at TICEL Bio Park is provided on Rent / Lease basis.

Tenancy rates of the park are shown in Table 2.1.24.

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Table 2.1.24 Tenancy Rates of the Park

(Rs./Sq. ft./month)

Labs No. of Modules Rent / Lease

(*) A/C (12 hours

operation)

Operation & Maintenance Charges (*)

Unfurnished wet

labs (BSL – 2) 42 30 15.0 12.00

Un furnished Dry

Labs 32 30 7.50 11.50

Total 74 - - -

Note: Service Tax extra as applicable

Source: TICEL Bio Park, Homepage

(6) Malaysia

1) Purpose and Background for Cluster Location

a) Bio Technology Industry in Malaysia

In line with global competition, Malaysia is actively building up its biotechnology

sector to spur the industry utilizing its rich resources and pool of skilled workers. In

its transition to a knowledge-based economy, the Malaysian biotechnology industry

will be given special focus during the period 2005 – 2020 guided by the

Biotechnology Master Plan created in the context of the National Biotechnology

Policy (NBP).

The NBP was enacted in 2005 and over the past 7 years, the industry has developed a

strong base and today Malaysia‘s biotechnology cluster has the potential to lead the

Asia Pacific region. The industry is projected to generate annual revenue of Euro

42.5 billion (RM (Malaysia Ringgit) 170 billion) by 2020.

Having completed the first phase of the policy from 2005 – 2010 focusing on

capacity building for the industry, the biotechnology industry led by Malaysian

Biotechnology Corporation Sdn Bhd (Biotech Corp, agency of the Ministry of

Science, Technology and Innovation) has entered the second phase of

implementation from 2011-2015 which involves commercialization activities and

realizing the value of the industry through various initiatives. In short, it is the stage

to bring the results from science to business.

Hence, in order to achieve that, efforts are being taken to lay a solid foundation

including developing human resource to create skilled workers, emphasizing

research and development in priority sectors as well as building technological

infrastructure and foster innovation and industry development.

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Table 2.1.25 Key Indicators for the Biotechology Industry as of 31st December 2011

Indicators Targets Achievements

In 2005-2011 period

Phase1 (2005-2010)

Phase2 (2011-2015)

Phase3 (2016-2020)

Total (2005-2020)

Investment by private sector and government

RM6 bil RM9 bil RM15 bil RM30 bil RM10.7 bil

Number of BioNexus companies

25 25 50 100 210

Employment (at end of period)

40,000 80,000 160,000 280,000 55,904

Annual revenue (at end of period)*

RM20 bil RM80 bil RM170 bil RM270 bil RM14.2 bil

Contribution to GDP

2.5% 4.0% 5.0% 5.0% 2.2%**

Note : * This is the total number/value at the end of each Phase. The Target for

2020 is the same as that at the end of Phase III.

** This is the total of GDP contribution reported as at the end of Phase I.

Source: Biotech Corp, BiotechCorp Annual Report 2011

Biotech Corp, Score Card Report (October 2011)

b) National Biotechnology Policy

The Malaysian Government being the main driver for the industry‘s growth has

developed a sound set of policy that ensures the development and strategic direction

of the biotechnology industry.

The key development areas under the National Biotechnology Policy (NBP) are as

follows:

Table 2.1.26 Key Development Areas under the National Biotechnology Policy

Thrust 1 : Agriculture Biotechnology Development

Transformation and enhancement of the value creation of the agricultural sector through

biotechnology

Thrust 2 : Healthcare Biotechnology Development

Capitalization on the strengths of biodiversity to commercialize discoveries in natural products as

well as position Malaysia in the bio-generics market

Thrust 3 : Industrial Biotechnology Development

Ensuring growth opportunities in the application of advanced bio-processing and

bio-manufacturing technologies

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Thrust 4 : R&D and Technology Acquisition

Establishment of Centers of Excellence, in existing or new institutions, to bring together

multidisciplinary research teams in coordinated research and commercialization initiatives.

Accelerate technology development via strategic acquisitions

Thrust 5 : Human Capital Development

Building the nation‘s biotech human resource capability in line with market needs through special

schemes, programs and training

Thrust 6 : Financial Infrastructure Development

Application of competitive ―lab to market‖ funding and incentives to promote committed

participation by academia, the private sector as well as government-linked companies, implement

sufficient exit mechanisms for investments in biotech

Thrust 7 : Legislative and Regulatory Framework Development

Creation of an enabling environment through continuous reviews of the country‘s regulatory

framework and procedures in line with global standards and best practices. Develop a strong

intellectual property protection regime to support R&D and commercialization efforts

Thrust 8 : Strategic Positioning

Establishment of a global marketing strategy to build brand recognition for Malaysian biotech

and benchmark progress. Establish Malaysia as a center for Contract Research Organizations and

Contract Manufacturing Organizations

Thrust 9 : Government Commitment

Establishment of a dedicated and professional implementation agency overseeing the

development of Malaysia‘s biotech industry, under the support of the Prime Minister and relevant

government ministries

Source: Ministry of Science, Technology and Innovation

c) Focus Areas and the Target Sectors

(i) Agriculture Biotechnology (Green Biotechnology)

The main objective is to enhance the country‘s agriculture products, particularly

the food and commodity crops, subsequently ensuring sufficient and sustainable

food supply. However, the government is giving importance to all these areas:

crop-related biotechnology, livestock technology, marine/aquaculture

biotechnology and natural products.

In 2011, the Ministry of Agriculture Malaysia has launched the National Agro

Food Policy which will cover a period from 2011 – 2020 and focusing on ensuring

the agriculture sector continues to drive the economy and provide adequate supply

of food as well as boost the valued added of food products. (Source: Bernama

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News, October 18, 2011)

Targeted Sectors

Bio-agriculture mainly includes the production of high yield crops, genetically

modified plant, livestock and poultry, transgenic animal, forestry products,

fisheries, aquaculture, value added products, biofertilizer and biocontrol,

biopesticides, cell culture technology, feed and additives, hybrid seeds, tissue

culture, nutraceutical and food technology.

(ii) Healthcare Biotechnology (Red Biotechnology)

Malaysia aims to thrive on the traditional and complementary medicine sector to

develop leads for the pharmaceutical and nutraceutical industries given the

country‘s rich resources, biodiversity and local knowledge. Also, due to

emergence of new and chronic diseases, the government is trying to reinforce a

better healthcare system for the population at large.

Targeted Sectors

Bio-healthcare covers tropical diseases, preclinical contract research, clinical

trial, diagnostics and biomedical instruments/devices, personalized and

preventive medicine, therapeutics, drug discovery, antibodies, recombinant

proteins, vaccines and bioactive compounds for healthcare, herbal products and

cosmeceuticals.

Among the above mentioned categories, the medical devices/IVD shows higher

involvement mainly due to the shorter time to market the products as compared

to others. Furthermore, it is easier to obtain funding from the financial

institutions as there is better understanding of the devices sector and is also

subjected to less regulatory control.

(iii) Industrial Biotechnology (White Biotechnology)

Industrial biotechnology in Malaysia tends to focus on the petrochemical and oleo

chemical segments as the country is rich in petroleum and oil palm resources.

Coupled with its strong background in manufacturing and outsourcing capabilities,

Malaysia is capable in fulfilling the local and foreign requirements.

The identified areas of growth include the development of biocatalysts such as

enzymes for food and feed preparations, cleaning products, textile processing and

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other industrial processes. Bioprocessing is another growth area which can be

applied in the production of biomaterials such as bioplastics, biofuel, specialty

chemicals such as cosmetics ingredients and electronic chemicals.

Targeted Sectors

Bio-manufacturing applies to the development of bio materials, enzymes

(biocatalysis), bio fuel, microbes technologies, biomass, bio-degradable plastics,

oleochemicals, bio-process engineering, fermentation, green chemistry and

contract manufacturing.

To develop the industry and spur commercialization activities, the National

Biotechnology Acquisition Program has acquired the following platform

technologies for the three biotechnology areas:

Table 2.1.27 Platform Technology Necessary for the Three Biotechnology Areas

No. Platform Technology Industry

1. French based Nanotechnology platform in non-oncology

applications. Help to further develop the segment of

biopharmaceuticals/pharmaceuticals and medical devices /

in vitro diagnostics

Healthcare

2. Australian based DotScan Antibody Microarray technology:

Development of immunoassay reagents and therapeutic

monoclonal antibodies

Healthcare

3. Canadian based Marker Assisted Selection (MAS) in plant

and animal breeding technology

Agricultural

4. Dutch based Supercritical Fluid Extraction (SFE) platform

technology. Extraction of high valued flavor/fragrances,

food ingredients, nutraceuticals, active pharmaceutical,

cosmeceutical ingredients and specialty industrial chemicals

Industrial

Source: Biotech Corp, Malaysia Biotechnology Guide

These platform technologies were chosen based on the country needs and they

can be applied across the sector for various applications. The objective is to

encourage more research applications to commercialize the technologies that

have been acquired.

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d) Achieving Bionexus Status

(i) Privileges under BioNexus Status

Through BiotechCorp, the Malaysian Government grants the ―BioNexus Status‖

to eligible companies where they can enjoy the following privileges under the Bill

of Guarantees as stated below:

Bill of Guarantees :

1. Freedom of ownership

2. Freedom to source funds globally

3. Freedom to bring in knowledge workers

4. Eligibility for competitive incentives and other assistance

5. Eligibility to receive assistance for international accreditations and standards

6. Strong intellectual property (IP) regime

7.Access to supportive information network linking research centres of

excellence

8. Access to shared laboratories and other related facilities

9. BiotechCorp as the one-stop agency

(ii) Pre-Requisites for BioNexus Status

-Establish a separate legal entity for the BioNexus qualifying business and

activities

-The company should already have projects ready for production and

commercialization. In the case of pre-commercialization stage with projects still

at the pilot plant development, beyond proof of concept and ready prototypes,

they will be considered on case by case basis. Early start-up companies with

conceptual or research stage projects will not be eligible.

-The company must use life sciences processes or biotechnology elements in

production or agriculture activities. Companies that provide and trade on

products and services and involved in mere blending, repacking, mixing,

distributing or trading activity will not be able to qualify.

-Possesses research capability and conducts research in focus areas : that is

agricultural, healthcare and industrial biotechnology.

-Employs a significant percentage of knowledge workers in its total workforce

-Complies with environmental and ethical laws and guidelines

e) Bio-XCell in Iskandar, Johor: Malaysia‘s Premier Biotechnology Park and

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Ecosystem

Spanning over 160 acres, Bio-XCell is a dedicated biotechnology park and

ecosystem for healthcare and industrial biotechnology sectors. Located in the

township of Nusajaya in the Iskandar region, it is only minutes away from Singapore

and is well placed between the East and West trade routes. Companies can take

advantage of the strategic location to have direct access to booming Asian markets. It

also has other advantages such as proximity to abundant biomass for use as feedstock

and renewable energy generation as well as business friendly incentives.

In Bio-XCell, investors will have efficient and reliable utilities for biomanufacturing.

In terms of infrastructure, as an alternative to purchasing vacant land and build the

facility, companies located in Bio-XCell can rent a shell facility, renovate and fit-out

the facility according to their operational needs. It also allows tenants to design and

customize facilities according to their own unique operational requirements with the

construction and set-up costs distributed across the lease period. This enables tenants

to move in and begin operations with minimal initial capital expenditure.

2) Approximate Investment Size and Main Investors

a) Regional Economic Corridors in Malaysia

Currently, there are five Regional Economic Corridors in Malaysia. Rather than

clustered, each corridor covers a huge area or a few states and is basically

geographically based. The five corridors are spread throughout the Peninsula

Malaysia as well as East Malaysia. Looking at the abundant natural resources,

infrastructure availability, technology and skilled workers as well as Government

support and business incentives the Economic Growth Corridors present great

opportunities to foreign investors not only in the area of biotechnology but others too.

Below is a brief introduction of the Corridors.

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Table 2.1.28 Main Biotechnology Corridors in Malaysia

Northern Corridor Economic Region

(NECR)

Iskandar Malaysia East Coast Economic Region

(ECER) Development period

2007 - 2025 2006 – 2025 2007 – 2020

Area 17,816 sq km 2,217 sq km 66,736 sq km Biotechnology Areas

GM crops, agricultural

biotechnology, industrial

biotechnology, manufacturing – medical, APIs

agricultural biotechnology, human capital, infrastructure, manufacturing

biomass/biofuels, GM crops,

nutraceutical, bioremediation, bioprocessing

Strengths Biodiversity & bioresources,

manufacturing and logistics

infrastructure

Location, logistic infrastructure, oil

palm

agriculture & acquaculture base, bioresources (oil palm, tobacco)

Expected employment

3.1 million 1.4 million 1.9 million

Sarawak Corridor of Renewable Energy

(SCORE)

Sabah Development Corridor (SDC)

Development period

2008-2030 2008-2025

Area 70,708 sq km 73,997 sq km

Biotechnology Areas

biomass/biofuels, livestock, bioremediation

biomass/biofuels, livestock& aquaculture,

bioremediation

Strengths focus on livestock

industry, biodiversity, oil palm

acquaculture base, biodiversity, oil palm

Expected employment

3.0 million 2.1 million

Source: Malaysian Biotechnology Corporation

b) Outline of Biotech Parks in Malaysia

In Malaysia, in order to accelerate biotechnology development, Ministry of Science,

Technology and Innovation installed the national biotechnology executive board

(BIOTEK) in 1995. In order to attain rationalization of biotechnology research,

BIOTEK prepared the seven biotechnology common centers (BCC). BCC adjusts the

biotech research which various research institutions do, aims at cooperation, and

avoids duplication. As for BCC, many are installed in institutions of higher education

(i) Technology Park Malaysia

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A. Outline of Technology Park Malaysia Corporation

Since its establishment in 1996, Technology Park Malaysia Corporation Sdn

Bhd (TPM) has continued to manifest in its underlying motto "Your Success

Begins Here" that has reached the length, depth and breadth of the

technopreneurial community.

More than 3,000 technology driven companies have benefited from TPM - both

local and multi-national within various clusters of industry. ICT cluster has

recorded the highest tenancy within TPM followed by Engineering and Biotech,

Telecommunication and Content, and Support Services.

Focused on the objective of creating this conducive environment for innovation,

TPM will transform itself with a five prong strategy which involves the

maximizing of its land assets, enhancing its commercialization and support

services, increasing the efficacy of its advanced infrastructure and networking

capabilities, elevating its 4th generation technology incubation programs and

developing start-up friendly policies to generate a proliferation of technology

based quality start-up companies with global potential.

TPM provides a unique comprehensive balance of technology, support and

R&D capabilities.

Main activities and supports by the corporation for incubation are as follows:

I. Rental of Incubator Premises

Suitable for scientists, researchers, technopreneurs and SMEs and lease of

land parcels for technology knowledge-based companies

II. Technology and Business Incubation Programs

Offerings include business mentoring and coaching services, business,

marketing & financial consultancy services, technology & business forums,

workshops and business matching to researchers, scientists, technopreneurs

and SMEs

III. Technology Commercialization Assistance and Support

Assistance and support in technology commercialization which include

advisory and consultancy services in technology transfer facilitation, project

management, strategic management advice, market research and opportunity

analysis and professional development programs

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B. Management of the Park

I. Community

Malaysia's pioneer technology park, TPM is a 700- acre development that is

home to more than 150 technology companies employing 10,000 knowledge

–workers. Strategically located in Kuala Lumpur, the campus is the premier

choice of location for technopreneurs, scientists or researchers and

knowledge- based companies.

II. Strategic Location

Conveniently located between Kuala Lumpur and Federal Government

Administrative Centre, Putrajaya, TPM is within proximity to major

universities and research institutes and government agencies. Amenities

available within the campus are sport amenities, shopping centers, banks,

clinics, schools, housing and commercial developments.

III. Flexible Office Solutions

TPM offers flexible incubator space and office premises to fulfill the

operational needs of companies at different level of growth stage. Attractive

government incentives and government funding for technopreneurs, MSC

and Bio-nexus status companies and technology based companies are

available.

IV. Integrated Facilities and Service Programs

TPM offers incubation support facilities such as life science laboratories,

engineering and ICT facilities. Incubation programs & services are offered to

incubatees and technopreneurs to ease their businesses and technology

development. The incubatees will work hand-in hand with the technical and

business experts to gain competitiveness.

C. Integrated Infrastructure of the Park

- Uninterruptible and fully backup electric power supply

- Centralized air-conditioning system (8am-6pm)

- Local Area Network (LAN) and wide bandwidth connectivity

- 24-hour security with surveillance system

- Open basement and multi-level car park

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D. Land

Various sizes of land plots are available for technology companies to sublease

and erect their own buildings. All land plots come with infrastructure and

facilities that fulfill the needs of technology companies.

E. Office Space

I. Rental information

TPM offers flexible office space and office premises to fulfill the operational

needs of companies at different level of growth stage. Attractive government

incentives and government funding for technopreneurs, MSC and Bio-nexus

status companies and technology based companies are available.

II. Lease Period

2 years and renewable every two years

III. Lease Commencement

As stated in the Letter of Offer and Tenancy Agreement

IV. Tenancy Agreement

Duration of agreement is 2 years from the commencement date of the

tenancy agreement. Any cost associated with preparation and enforcement of

the Tenancy Agreement including stamp duty and legal fees, directly or

indirectly, shall be borne by the tenant.

V. Handover Date

The premise will only be handed over after initial payment (deposits),

signing of Tenancy Agreement and preparation of standing instruction (for

payment of monthly rent).

VI. Office Renovation

Related technical and layout drawing for office renovation must be certified

by respective technical expert and to be submitted to the Facilities

Management Department (FMD). Approval must be granted by FMD prior

to office renovation.

VII. Service Charge

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A service charge of RM1.50 is included in the rental rate which is made up of

the following:

- Quit rent

-Air conditioning (Monday to Friday, 8.00 a.m. to 6.00 p.m.)

-Electricity and water supply to common area

-Building insurance

-Building security charges

-Building and landscape maintenance

F. Facilities and Services

The Park Management ensures for the following facilities and amenities are

made available to all tenant companies and their employees:

-Technoflex

-Amenities

-Information Resource Centre (Library)

Technoflex Amenities

Information Resource Center (Library)

Source: TPM HP

Figure 2.1.49 Examples of Facilities and Common Space

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TPM also offers the use of its facilities to tenants and third parties at very

reasonable rates. The following support facilities and amenities are made

available to address the business and general needs of tenant companies:

-Conference and meeting rooms

-Function/exhibition area

-Court game facilities

G. Centre for Technology Commercialization

The Centre for Technology Commercialization (CTC) is dedicated to stimulate

the needs of the country's key stakeholders in harnessing technology for wealth

creation. Universities, research institutes, venture financiers, technopreneurs,

intellectual property specialists, governmental regulators, researchers, business

entities and industry players will come together at CTC to make technology

commercialization a reality.

The CTC offers advisory and consultancy services in facilitating technology

transfer, R&D commercialization, project management, strategic IP

management advice, market research and opportunity analysis as well as

professional development programs to increase commercial potential of

projects.

CTC is working with the Innovation and Commercialization Division of the

Ministry of Science, Technology and Innovation (MOSTI) towards the

commercialization of products developed through R&D activities sponsored by

the Ministry, by way of MOSTI/TPM Products Commercialization Prospecting

Sessions. CTC's Project Monitoring Team (PMT) has also been appointed by

MOSTI to manage and monitor grants given out under the Technofund,

Sciencefund and Innofund grants. These grants are for the Biotechnology,

Agriculture and Industry Clusters, to encourage development of new products

for commercialization.

Main activities of CTC are characterized as follows:

-Equipped with experienced managers, CTC's service offerings include the

facilitation of business matching for start-ups and early stage enterprises for

the following:

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•Conducting market survey for companies intending to embark on new

product development recognizing the importance of knowing which

features are needed or often used by customers and what kind of support

they require.

•Organizing roundtable discussions with relevant technical and business

experts to develop the best possible strategies and bringing new

intellectual insight for specific business enhancements.

-Sourcing of experts and advisory personnel to be part of organizations that

require such services on specific needs or retainer basis.

-Developing links between institutes of higher learning, Government R&D

institutions, funding organizations and Government implementing agencies

- parties that form the research and innovation value chain.

H. Innovation Incubation Centre

The Innovation Incubation Centre (IIC) aspires to accelerate the growth of

technopreneurs in the renewable energy, ICT, biotech and engineering

industries to grow from ideation to commercialization via provision of

intervention programs in critical areas.

I. Objectives

-To incubate and nurture knowledge-based enterprises by providing expertise

and support in technical & business skills

-To provide handholding services which include comprehensive coaching,

mentoring, consultancy & training to enhance technopreneurship

-To facilitate technopreneurs for better access to funding

-To facilitate Research and Development, Innovation and Commercialization

activities by providing advanced infrastructure, equipment and facilities

-To facilitate government and private sector smart partnerships in technology

development and commercialization of research results

-To provide a platform for the establishment of strategic business, and market

linkages for the incubates/technopreneurs with MNC's, GLC's, research

institutes, academia, financial community and industry, locally and globally

II. TPM Biotech Sdn Bhd

TPM Biotech Sdn Bhd (TPMB) was established in 2004 as a fully owned

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subsidiary of Technology Park Malaysia (TPM) Corporation Sdn. Bhd., a

Malaysian government–linked company. There are two divisions in TPMB:

Biotechnology Development Centre and Herbal Biotech Center.

Biotechnology Development Centre is located at Bukit Jalil, Kuala Lumpur.

This division is the focal point for all biotechnology services. In addition to

this, it is also the centre of all sales and marketing activities.

The Herbal Biotech Centre (HBC) is located at Kg. Ulu Sungai, Batu Talam,

in the district of Raub, Pahang, approximately 190 km from Kuala Lumpur.

HBC is a processing centre where all semi-finished and finished herbal

based products are produced.

Malaysia is well known for her rich biodiversity, and TPM's recognises the

potential and opportunity to exploit this abundance in natural resources.

Taking cognizance of the growing global interest and demand in natural

products, TPM Biotech Sdn Bhd was established.

(ii) Bio-XCell

A. Outline of Bio-XCell

Malaysian Bio-XCell Sdn. Bhd. - comprehensive, state-of-the-art

biotechnology ecosystem in Malaysia with the objective of Biotechnology park,

Bio-XCell aims to build a conducive Biotechnology ecosystem to support

manufacturing and R&D for the industrial and healthcare Biotechnology

sectors. It is a platform where Malaysia pools the soft infrastructure financial

incentives, human capital development, business and operational set-up,

advisory and services and attractive leasing models, along with the hard or

physical infrastructure that will enable companies to springboard their

Biotechnology business and commercialisation activities.

Bio-XCell is a joint venture between BiotechCorp and UEM-XCell project

entails the development of a 72.53-acre biotechnology park in Iskandar

Malaysia, Johor. The biotechnology park will be developed in three phases over

a span of six years, to provide an estimated 1.125 million square feet of

dedicated, purpose-built space and facilities for biotechnology companies.

To date, Bio-XCell has clinched some RM1.146 billion million investments

from deals with three companies, namely India's Biocon Ltd, French group

Metabolic Explorer (METEX) and Houston, Texas group Glycos

Biotechnologies (GlycosBio). Biocon would focus on R&D and production of

high-end biosimilars and other biopharmaceutical products in Bio-XCell. The

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investment is the largest for the Malaysian biotechnology sector thus far. In the

first phase, Biocon proposes to invest around RM1.0 billion in this facility

which is targeted to be operational by 2014.

B. Land Scheme

Customise your operations to maximize efficiency with our Standard Shell

Scheme. Readily available plants with standardized layout provides the

flexibility to move-in and renovate or fit-out according to operational needs.

- Land size of 1 acre with built-up area of approximately 20,000 sq ft

- Allocation to build and additional floor for extra space (At tenant‘s own

expense)

- Minimum tenancy period of 3 years

Source: Bio-XCell HP

Figure 2.1.50 Plot Plan of Bio-XCell

C. Lab Services

Innovation is part of our culture at Bio-Xcell. Realising the necessity of

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well-equipped facilities to help propel research and manufacturing to the next

level, we have laboratories, incubation centres, pilot plants and a customized /

centralized utility facilities.

I. Shared Laboratories

At Bio-Xcell, we understand that collaboration can act as a catalyst for

invention. That is why our shared laboratories facilities aim to bring

academia, institutes of higher learning and entrepreneurs passionate about

biotech together to accelerate research and innovation.

-Pay per use

-Piped-in gases

-Fume hoods

-Risers and chimney stacks

-Waste management services

-Business centre for administrative support

II. Incubation

Attention to detail matters and at Bio-Xcell, we don‘t believe in compromise.

Our facility provides the perfect incubation space complete with technical

infrastructure necessary for research and innovation.

-Pay per use

-Piped-in-gases

-De-ionised water

-Laboratory furniture

III. Pilot Plant for Testing and Demos

Setting up an entire fully operational facility is not just a hassle but a big risk

too. At Bio-Xcell, we provide you the chance to minimize that risk by setting

up a pilot plant facility that will provide for continuous enjoyed benefits of

our facilities and biotech ecosystem as a whole.

The plant intends to:

-Enable biotechnology companies to test and validate formulations for their

products prior to scaling-up of operations

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-Serve as demonstration plants which may be used to produce samples

which may then be given to potential clients prior to the completion of the

commercial-scale plants

-Facilitate product testing and procurement of regulatory approvals (i.e.

National Pharmaceutical Control Bureau (NPCB) prior to scale-up

D. Business Services

I. Customizable Office Spaces

A comfortable working environment is essential for optimal productivity.

With customizable office spaces and layouts, personalising your office space

to accommodate everyone‘s needs is now possible. Service providers to

companies within Bio-Xcell such as law and accounting firms are most

welcome to be a part of our ecosystem.

Space is flexible from 300 to 2000 sq ft and tenancy will be for a minimum

period of 3 years.

II. Convenient Retail Outlets

With a variety of retail outlets, food and beverage outlets, banks and other

related services within the area, your errands won‘t get in the way of your

work again.

E. Training and Conference Amenities

As a premier biotechnology ecosystem, we provide world-class training and

conference facilities complete with audio-visual and related training

equipment.

I. Auditorium

Large theatre-styled hall suitable for lectures and corporate events

II. Conference / Seminar Rooms

Multi-purpose rooms suitable for small or large conferences, seminars,

meetings or any other corporate use

F. Leasing Opportunities

I. Incubator and Lab Spaces

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Table 2.1.29 Example of Incubator Lab Space

Item Description

Price Range Early Bird Rate: RM 11.00 per sq.ft. /month

Features and Offerings

Incubator space with airlock entry

Adjacent Lab office space

Centralized Air Conditioner 8:30-5:30pm (Mon-Fri)

Facilities Management included

Complimentary Wi-Fi

Note

Signed Letter of Intent

Deposit of 1 month rental

Provision of company profile and intended business/brand

36 months lease period

Source: Bio-XCell, Homepage

II. Bare Lab Spaces

Table 2.1.30 Example of Bare Lab Space

Item Description

Price Range Early Bird Rate: RM8.00 per sq.ft. /month

Features and Offerings

Bare space to be fitted out, 10,000 sq.ft

Suitable for CRO, Central Lab & Regional HQ

Centralized Air Conditioner 8:30-5:30pm (Mon-Fri)

Facilities Management included

Complimentary Wi-Fi

Note

Signed Letter of Intent

Deposit of 1 month rental

Provision of company profile and intended business/brand

36 months lease period

Source: Bio-XCell, Homepage

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2.1.2 Example of Biocluster in Japan

(1) Outline of Biocluster in Japan

Japan has various industrial clusters. The clusters with theme of Bio including life science are

shown below. METI (Ministry of Economy, Trade and Industry) designated 8 bioclusters in

2013through current cluster policy.

Table 2.1.31 Bioclusters in Japan

Name of Bioclusters Designated

by METI

Incubation center with

wet laboratory

Japan Hokkaido Forum of Bio-industry Cluster ● 1 incubation center

Tokachi Region Agricultural Bio Cluster None

Hakadate Marine Bio Cluster None

Promoting Formation of Bio Cluster in

Yamagata Prefecture None

Shimotsuke Bio Cluster None

Metropolitan Bio Network ● 12 incubation centers

Project of Tokai Bio Manufacturing ● 2 incubation centers

Life Science City in Yokohama 3 incubation centers

Farm-valley in Foot of Mt.Fuji None

Nigata Bio Research Park 1 incubation center

Project of Hokuriku Manufacturing Creation ● 1 incubation center

Toyama Bio Valley None

Nagahama Bio Cluster 1 incubation center

Bio Cluster Project in Kansai ● 2 incubation centers

Development Organization of Kinki Bio

Industry None

Mie Medical Valley None

Kyoto Bio City 7incubation centers

North Osaka Bio Cluster 3 incubation centers

Kobe Biomedical Innovation Cluster Kansai International strategic zone

(2013-), 7 incubation centers

Hiroshima Bio Cluster None

Forming Project of Core Industry for Next

Generation ● 1 incubation center

Shikoku Techno Bridge Planning ● None

Bio Cluster Planning in Kyusyu Region ● 2 incubation centers

Kurume Biomedical Innovation Cluster 1 incubation center

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Note: Incubation centers have no relevance with clusters in some cases. Operator of biocluster is

normally different from the operator of Incubation center.

Source: JICA Study Team

These eight clusters are designated to locate in each part of Japan by government policy, but the

clusters are usually configured with a range of prefecture level because of administrative reason.

The clusters are information networks aiming at building relationship among

industry-academia-public. The operators of the networks are various, and those are not

necessarily accompanied by incubation facilities. Three typical types of bioclusters are 1) large

scale of participants in wide area, that is, the type of ―open networking‖, 2) information

originating from the core facilities, that is, the type of ―networking from core facility‖, and 3)

Industry-Academia-Public being operated by public sector, that is, the type of ―finding and

exchanging local seeds for innovation.‖ Examples of the these types are as follows:

1) Metropolitan Bio Network (Designated by METI, Bio Industry Association)22

At first, it was established as Metropolitan Bio Genome Venture Network in 2002, and

its main roles were development of network, coordination of business and supports for

bio ventures.

Thereafter completion of reading the human genome, the network has been operated

continuously by Bio Industry Association. The Metropolitan Network has more than

450 members currently, and they transmit and share information mutually. The

association arranges bases and opportunities for collaboration, provides appropriate bio

ventures with information and develops advising business by coordinators. Open

innovation system to obtain resources widely from outside is becoming essential,

because of developing medicine efficiently. In this stream, the association is focusing on

strengthening network not only of domestic bioclusters, academia and bio ventures but

also with overseas clusters and supporting associations.

2) Life Science City in Yokohama (Led by Yokohama City) 23

Yokohama Bio Industry Center is located in Yokohama Science Frontier District where

Yokohama City develops in Tsurumi Ward. There are Institute of Physical and Chemical

Research (RIKEN) and IDEC (Incubation Center) in the district. Yokohama Bio

Industry Center has many tenants in the rental R&D rooms. Yokohama Bio Medical

22 http://www.jba.or.jp/syutokenbio/about/ 23 http://wuctedww.sanken.osaka-u.ac.jp/labs/bse/homepage/kihara.htm

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R&D (YBIRD) was developed with subsidy of METI in 2009. And the organization

opens technical training and human resource development by lectures. The main body

of the operation is Kihara Foundation, and it also operates Yokohama, Kanagawa Bio

Business Network. This is an example that the facilities were constructed by local

government utilizing subsidy of national government. After completion of construction,

affiliated organization will operate the beneficial business such as operating facilities

and contracted researches.

3) Kyoto Bio City Conception (Led by Kyoto Municipal Government) 24

In the field of life science, Kyoto Bio City Conception works together with

industry-university public cooperation in order to promote forming new industry that

leads the next generation, utilizing advanced group of companies, universities with a

wide range of research results. It promotes joint research projects with a focus on

universities and companies, and plans and manages the symposium and research

meetings for the purpose of the consortium on the theme of food, measurement, life

sciences, etc. Three major fields of R&D projects in particular are as follows:

a) Fusion Fields of Medical and Engineering

R&D and commercialization of state-of-the-art technology that contributes for

high-altitude medical and biological phenomenon through the integration of

medicine and engineering

b) Field of Environment

Construction of utilizing biological circulation systems such as biodegradable plastic

c) Field of Utilizing Local Resources

Material production plant of using industrial rearing system of silkworm, and R&D

on industrial utilization

4) Kansai Bio Cluster

The Kobe Medical Industry Town and North Osaka Bio-cluster are forming a medical

cluster in Kansai.

In the Kobe Medical Industry City, the measure led by Kobe Municipal Government

started around 1998 as one of the prime projects of the earthquake disaster revival from

the Great Hanshin-Awaji Earthquake. Accumulation of R&D centers (a hospital, a

24 http://www.astem.or.jp/biocity/

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medical-supplies company, a medical equipment company, etc.) of advanced medical

technology was prepared in Port Island of the man-made island. It aimed at activation of

the medical industry and improvement in medical service. The cooperation reinforces

accumulation base with hospitals, incubation facilities, the facilities for research, etc.

Table 2.1.32 Core Facilities in Kobe Medical Industry City

Field Name Funded by Open Area(m2)

Medical

Facilities

Generation& and Regeneration

Institute

Riken 2002 19,700

Advanced Medical Center Kobe city 2003 10,000

Kobe Biotechnology Research

and Human Resources

Development Center

Kobe University 2004 2,000

Kobe Medical Equipment

Development Center

SME Organization 2006 3,250

International Medical

Development Center

Kobe International

Friendship Fund

2011 4,300

Kobe International Business

Center

Kobe City Fund 2001 20,000

Kobe Hybrid Business Center Advanced Medical

Fund

2011 2,000

University

Hyogo Pref. University Hyogo Pref.

University

2011

Kobe University Overall Center Kobe University 2011 2,500

Other Super Computer Riken 2012 20,000

Source: Development Bank of Japan (DBJ) Report

The North Osaka Bio-cluster started from the formation of the Senri Science Promotion

Foundation for the purpose of the life advance in North Osaka. In addition to the

industrial, administrative and academic sectors cooperation, reinforcements of Osaka

University, the National Circulatory Disease Research Center, and research institutes of

private enterprises which established earlier, attraction of drug design base and the

establishment of incubation facilities in Saito Life-science Park have been performed.

The public research institute was founded under the Kobe Medical Industry City

Foundation in cooperation with independent companies. Construction subsidies and

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operation costs are subsidized from the administration.

Table 2.1.33 Core Facilities in Kita Osaka Biocluster

Field Name Funded by Open Area(m2)

Medical National Circulatory

Organ Institute

National Circulatory Organ

Institute

1977 n.a.

Medical Fundamental

Institute

Medical Fundamental Institute 2005 n.a.

Osaka Bio Science

Institute

Medical Fundamental Institute 1987 n.a.

University Osaka University Osaka University 1931 n.a.

Incubation

facility

Saito Incubator Regional Promotion

Organization

2004 4,900

Saito Bio Center Yashima Farma 2006 3,575

Saito Bio Innovation

Center

SME Promotion Organization 2008 2,737

Source: DBJ Report

(2) Example of Incubation Centers in Japan

There are many incubation offices including those for IT ventures. The number of the

incubation officessupported by Ministry of Economy, Trade and Industry (METI) in Japan is

176.

Among them, ―Wet laboratories‖ for bio experiments are few, and most of the laboratories are

prepared by Organization for Small and Medium Enterprises and Regional Innovation.

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Table 2.1.34 Incubation Facilities Supported by METI

Implementation Body Number of Facilities

Organization for Small and Medium

Enterprises and Regional Innovation 24

Local Governments 119

Third Sector Funded by Public and Private 33

Total 176

Note: Some of the above facilities do not include wet laboratories for bio experiments. Source: Study Group, Secretariat of Regional Innovation, 1998 http://www.meti.go.jp/committee/materials/downloadfiles/g80303b03j.pdf

Table 2.1.35 Examples of Wet Laboratories for Bio Experiments

(Selected 45 examples)

Owner Size Remarks

Organization

(Note 1)

Public-

Private

Rental

Area

(m2)

Total

Floor

Area(m2)

Rentable

Ratio

Common

Labo

Hokkaido Univ. Business

Spring ● 1,136

Tohoku Univ. Business

Incubator ● 1,621 2,483 0.65

Tokyo Univ. Kashiwa

Venture Plaza ● 1,687

Tokatsu Techno Plaza ● 11,881

Tokyo Institute of

Technology Yokohama

Venture Plaza

● 1,829

Creation Core Kazusa ● 882 1,449 0.61

Kazusa Bio Incubator ● 496

Hamamatsu Innovation

Cube ● 2,139 3,021 0.71

Venture Plaza Funabashi ● 1,463 2,366 0.62

Chiba Univ. Inohana

Innobation Plaza ● 1,848

Wako-Riken Innovation

Plaza ● 1,773

Noukou Univ. Tama

Koganei Venture Port ● 1,059

Nagoya Medical Industry

Incubator ● 2,142

Ishikawa Univ. Incubator ● 1.563

Ritsumeikan Univ. BKC

Incubator ● 1,362

Kyoto Univ. Katsura

Venture Plaza ● 3,693

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Owner Size Remarks

Organization

(Note 1)

Public-

Private

Rental

Area

(m2)

Total

Floor

Area(m2)

Rentable

Ratio

Common

Labo

Creation Core Kyoto

Mikuruma ● 1,480

Doushisha Univ.

Entrepreneur Training

Facility

● 1,503

Kyoto Sangyou Kagaku

Technology Integration

Inovation Center

Private (Note 3)

Uji Vennture Enterprize

Development Factory (Bio

Wing)

● 1,250.72

Kyoto-Fu Keihanna Venture

Center ● 1,102

National Institute of

Advanced Industrial Sciece

(AIST) and Tech, Kansai

Industry-Univ. Coorperation

AIST 1,720 5,750 0.30

Kobe Medical Instruments

R&D Center ● 1,435 2,100 0.68

Kobe Medical Device

Development Center ● 1,387 3,600 0.39

Saito Bio Incubator ● 3,700 4,900 0.76

Saito Bio Incubation Center ● 1,730 2,500 0.69

Saito Bio Hills Center Private 830

Osaka University Sanken

Reseasrch Park Osaka University 1,471

Creation Core East Osaka ● 1,019

Okayama Univ. Incubator ● 1,086

Kumamoto Univ. Incubator ● 982

Nagasaki Dejima Incubator ● 971

Kobe Advanced Medical

Center ● Hospital

ancillary

facilities

Kobe Baio Medical Creative

Center ● (6,391)

(Note 2)

11,620 (0.55)

(Note 2) (Note 3)

Kobe International Business

Center ● (10,962)

19,930 (0.55)

(Note 2)

Kobe Incubation Office ● (4,125)

(Note 2)

7,500 (0.55)

(Note 2)

Kobe Highbrid Business

Center ● 718

Tsuruoka Metabolome

Cluster ● 5,140 8,171 0.63 (Note 3)

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Owner Size Remarks

Organization

(Note 1)

Public-

Private

Rental

Area

(m2)

Total

Floor

Area(m2)

Rentable

Ratio

Common

Labo

Nagahama Bio Incubation

Center ● 1,124 1,625 0.69

Yokohama City

Industry-Academia Joint

Research Center (Research

Wing)

● 1,225 2,869 0.43

Leading Venture Plaza

(Wing 1) ● 3,100 5,390 0.57

Leading Venture Plaza

(Wing 2) ● 1,665 3,180 0.52

Fukuoka Bio Incubation

Center ● 759 (Note 3)

Fukuoka Bio Factory ● 1,500

Tottori Bio Frontier ● 490 1260.84 0.388

Total Floor Area (Excluding Note 1)

Total Floor Area (Including Note 1)

63,306

(84,784)

m2

m2

Note 1: Organization for Small and Medium Enterprize and Regional Innovation, Japan

Note 2: Rentl room is calcurated assuming the rentable ratio as 0.55.

Note 3: Facilities including common laboratories with analizing equipments to be able to

utilize with former appointment.

Source: JICA Study Team

1) Wet Laboratories

Though the facilities shown in the above table are including wet laboratories, the actual

area for the laboratories is 70 to 80 % of the total, because the floor area includes not

only laboratories but also research rooms and offices. Most of the incubation centers

were supplied by Organization for Small and Medium Enterprize and Regional

Innovation. It is rare case that universities or private companies construct the facility

themselves without public fund.

In many cases, incubation centers were constructed by receiving subsidies which were

used for part of the initial costs. Such subsidies are usually used for operation costs

for personnel, such as an incubation manager. Purpose of establishing an incubation

center is promotion of small and medium enterprises, so the rental rates are being set at

lower levels than those of nearby offices. In addition, local governments intend to

support tenants of younger ventures with subsidies. As such subsidies come from tax

revenue, ventures supported with subsidies must move out after staying at incubation

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centers for a few years. If the expensive experimental equipments are provided by

tenants, there is a problem that they cannot recover the costs within such short period of

time. In some cases in Japan, to solve such a problem, tenants can stay at wet

laboratories up to 15 years.

2) Rentable Ratio

When zoning inside of the building, corridors, stairs and elevators will first be

determined, meeting rooms, exchanging lounge, consultation rooms and offices will be

located on the ground floor, and then the whole facility will be designed.

If ―rentable ratio‖ is smaller against the total floor area, rentable floor area per

construction area will be smaller (getting worse). On the other hand, if rentable ratio is

larger, the common spaces would be smaller, and without enough space, the facility

would lose added value. So, well-considered planning with balanced rentable ratio is

required.

Especially, the rentable ratio affect the feasibility of the center operation, it must be

determined by studying the situation of the similar cases. Normally, rentable ratio is

used as a measure for efficiency of rental management.

The rentable ratio is around 80% for small offices and around 60 to 70% for large scale

offices. In the case of Hamamatsu Innovation Cube for reference, it is 78.95% on the

third floor. In this case, there is a common area such as corridors, an elevator, elevator

halls, staircases, toilets, a shower room and office kitchenettes. In this case, laboratories

are located on both sides of the center corridor with one set of staircases, so that the

plan is the most efficient as the standard floor for incubation centers. However, if

replacing the blocks of laboratories with meeting rooms and exchanging space, the

rentable ratio would go down to around 50 to 60%.

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Rentable ratio for standard case=a/(a+b)

Rentable ratio for Incubation Center=a/(a+b+c)

Source: JICA Study Team

Figure 2.1.51 Rentable Ratio

Examples of incubation centers and rentable ratios are shown at Table 2.1.35. In general,

the rentable ratio will be most effective if laboratories are set to be located along both

sides of the center corridor on the standard floors.

In case of arranging offices, meeting rooms, as minimum requirement, the rentable ratio

might be 60 to 70%. The rentable ratio of NARC incubation center will be assumed to

be 60 to 70% on the standard floor.

3) Floor Area per Room for Wet Laboratories

We took samples of average floor area of Japanese incubation centers which are

operated by Organization for Small and Medium Enterprises and Regional Innovation.

Table 2.1.36 Area per Room for Wet Laboratories

(m2)

Wet Laboratories

Average Max. Min.

Tsuruoka Metabolome Cluster - 155.53 73.4

Yokohama City Industry-Academia

Joint Research Center - 150 50

Leading Venture Plaza(Wing1) - 100 50

Leading Venture Plaza(Wing2) - 90 45

Tokyo University Venture plaza 45.5 63 32

Yokohama Institute of Technology

Venture Plaza 70.4 156 43

Rental laboratory(Exclusive Use)

Corridor

Entrance hall

Toilet

Hot water room

Mechanical room

Total floor area

Common Laboratory

Office

Meeting room

Storage

Cargo EV

Backyard

Special mechanical RM

Standard common spaces for

office building

Specific common spaces

for Incubation Center

Area-a

a

Area-b

a

Area-c

a

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Kazusa Bio Incubator 99 100 99

Hamamatsu Innovation Cube 62.8 63 24.5

Venture Plaza Funabashi 45.8 63 26.25

Kobe Medical Device Development

Center 59.8 80.5 31.5

Kobe Healthcare Industry

Development Center 57.8 80.5 40

Source: Organization for Small and Medium Enterprises and Regional Innovation HP

The average area for one room in incubation centers is around 45 to 99 m2, though it is

very hard to find out typical size of the room. However, it is clearer to find the average

sizes for minimum and maximum rooms. Most of the largest type is 63 m2. This number

is assumed to come from standard structural column span of the building with 7 by 9

meters. In addition, half of the standard structural span is assumed to be size of a

minimum rentable room.

RC structure is main construction method in Indonesia, so that 1 span will be shorter

than the span made of steel structure. If we set the RC span to be 8m by 6.5m

(measurement by the center of the wall), the standard room will be 52 m2.

Also in the case of NARC, standard laboratory type will be 52 m2 (8m×6.5m ×1 span)

and larger laboratory type will be 104 m2 (8m×6.5m×2 spans).

4) Rentable Area per Researcher

Standard researcher (experimental) room‘s floor area is 54 m2 (span of 9 m by 6 m) for

5 persons. So the rentable floor area per researcher is around 10.8 m2. It should be noted

that public space such as corridors and meeting rooms are not regarded as rentable.

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Source: Yamato Scientific Corporation Co., LTD, ―Design of Laboratory‖

Figure 2.1.52 Plan of Standard Research Room

(Approximately for 5 Persons)

2.1.3 Example of Biocluster in Europe and the US

(1) Representative Biocluster in Europe and the US

Table 2.1.37 shows famous bioclusters in the world and they are located mainly near universities.

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Table 2.1.37 Representative Bioclusters in Europe and the US

Country Location Field Number of Bio-related

Enterprises

US Boston Medical Equipment,

Bio

250 (US 18%)

North Carolina Medicines, Bio Venture 140,

Bio Research 65

UK Cambridge Bio 150

German Munich Medicines, Bio 100 with 31 Ventures

Finland Owl Biomedical High Tech Company more

than 500

Source: Mitsubishi Research Institute

Table 2.1.38 Bioclusters Ranking by European Commission

Ranking Country Name Region Evaluation

1 UK Cambridge Worldwide Cluster

2 US Sandiego

3 France Genpole Matured Stage Cluster

4 Danish/Sweden Medicon Valley

5 Norway Technopol

6 Japan Hokkaido Bio Cluster/Forum

7 Canada Saint-Hyacinthe

8 German Munich

9 Sweden Biotech Umea Developing Stage

Cluster 10 France/German/Swiss Biovalley

11 Austria UAFC

12 Belgium Gent

13 France IAR

14 Netherland Food Valley

15 Spain Biocat Initial Stage Cluster

16 Bioval

Source: METI Hokkaido Bureau of Economy HP

(2) Biocluster Ranking by European Commission

Table 2.1.38 shows biocluster ranking by the European Commission. It is thought that there is

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useful information which serves as reference of the bioclusters in newly emerging countries. The

evaluation criterion of the Europe commission is shown in below. In addition, this evaluation

criterion has put emphasis not on economic impact but diversity of the bio-field of non medical

treatment. There are two clusters called Basel and Bio-Alps in Switzerland. Especially, Basel is

the international center of pharmaceutical industry, though it is not described by the ranking by

European Commission. Moreover, the notable clusters are not chosen in the case of Japan. Also

from these, the ranking is set accoding to the characteristic bioclusters in the world.

1) Cluster of Worldwide Scale: 20 to 30 years have passed since formation, and there are 2

to 3 important fields.

-The cluster is bearing the important innovation of companies. Funds can be raised even

when it is difficult for companies.

-A Nobel prize winning researcher and several persons with world class technique have

formed the cluster.

2) Developing Stage of Cluster

a) Matured Biocluster

-10 to 20 years have passed since formation. The scale of cluster, growth and activity

are taken attention.

-The research institution of the cluster has received the high evaluation in their countries.

The cluster leads key industries.

-A cluster has a powerful platform and provides the participating organizations with the

incentive.

b) Developing Biocluster

-Five to ten years have passed since formation. Strong points are accepted, with

synergistic effects with other fields.

- As a cluster grows, formation of new companies can be caused.

Infrastructure for a cluster, such as an incubator is accumulated. A cluster plays a role

of attracting talented people.

c) Initial Stage Biocluster

-There is an important field newly coming from the cluster and formation of an

inauguration stage. The strategic master plan was formulated and tackled.

-Organization is formulated for a cluster and makes it possible to attract funds for new

business.

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-New employment is created and information can be delivered to the talented people

outside the district.

2.2 Investment Trend of Bioindustry Capitals

2.2.1 Investment and R&D Activities Trend of the World in Biopharmaceutical

While the U.S. is still the world leader with a growing biopharmaceutical base, a closer look at the

trends suggests that U.S. dominance in the biopharmaceutical sector is facing broad international

competition, with U.S. market share of worldwide activity declining. One good way to consider

this shifting global competition is to examine key performance measures across economic activity

and innovation in biopharmaceutical development.

In economic activity, two measures are considered. One is net output of pharmaceutical

manufacturing, and the other is export of pharmaceutical goods. Table 1 shows both the levels

and changes over the past decade in these two measures of economic activity for the world, the

U.S., the E.U., and the 18 comparison nations for this study. While the size of the U.S.

pharmaceutical economic activity remains substantial and is growing, it is not keeping pace with

overall world growth. Of particular note is that other nations, while at a substantially lower base,

are making major gains well above world growth rates.

In pharmaceutical net output, while the world grew by 109 percent from 2000 to 2010, the U.S.

grew a sizable, though lagging, by 72 percent. The fastest-growing nations in pharmaceutical net

output from 2000 to 2010 are China at 719 percent, Russia at 359 percent, Israel at 278 percent,

and Singapore at 274 percent25

.

Similarly, in exports of pharmaceutical goods, the U.S. is a significant player, though not

dominant given the size of its internal market. The U.S. grew at a substantial 240 percent from

2000 to 2010, but still behind the hefty world growth rate of 325 percent. The fastest-growing

nations in the export of pharmaceutical goods from 2000 to 2010 include Israel at 1,410 percent,

Ireland at 548 percent, Singapore at 503 percent, China at 498 percent, and Brazil at 412

percent26

.

It is interesting to note that the position of the U.S. is similar to that of the overall E.U. in terms of

pharmaceutical net output level and growth-both accounting for slightly more than a quarter of

world pharmaceutical net output but lagging world net output growth rates. However, the overall

E.U. connection to global markets appears substantially stronger than the U.S. as shown in total

export levels-even when accounting for intra-E.U. trade. Germany is an exception among the

25 See National Science Foundation 2012 Science and Engineering Indicators. 26 See World Trade Organization.

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leading developed nations as it continues to outpace world growth rates in pharmaceutical net

output and exports.

It is also important to note that the faster growth of economic activity in pharmaceuticals,

particularly by emerging nations, is similar to the overall growth expected in the demand for

pharmaceuticals across the world. Datamonitor reports that the global pharmaceuticals market is

expected to grow from $733 billion in 2010 to $981 billion by 2015, an increase by 33.8 percent.

This healthy growth of the pharmaceuticals market is largely driven by emerging nations, with

demand for pharmaceuticals expected to grow from 2010 to 2015 in China by 109 percent, and

Brazil by 67 percent. By contrast, the U.S. is expected to increase its demand for pharmaceuticals

from 2010 to 2015 by 31 percent, slightly below the world growth rate. This demonstrates a major

market opportunity going forward in the demand for pharmaceuticals among many emerging

nations with rising populations and incomes27

.

Table 2.2.1 Biopharmaceutical Economic Activity Measures by Country

Pharmaceuticals, Net Output Exports of Pharmaceutical Products

Country 2010 Level (US$ Million)

% Change 2000-2010

2010 Level (US$ Million)

% Change 2000-2010

World 345,994 108.6% 461,267.8 324.5% United States 91,903 72.3% 44,582.9 239.8%

EU* 90,418 95.6% 295,144.4 326.1% Australia 2,597 191.1% 3,584.0 207.4% Brazil 11,683 191.6% 1,360.4 412.1% Canada 4,215 138.8% 5,703.6 364.6% Chile 370 70.5% 128.3 258.5% China 63,316 718.5% 10,688.8 497.6%

France 11,324 49.7% 34,479.8 229.6% Germany 19,546 129.7% 66,937.7 386.7% Ireland 5,035 151.1% 32,178.1 547.5% Israel 949 278.1% 6,475.1 1,409.9% Italy 9,379 52.2% 17,675.8 177.0% Japan 30,015 ‐3.4% 4,324.0 58.3%

Russia 1,784 358.6% 583.0 289.2% Saudi Arabia 73 82.5% 47.7 113.8% Singapore 6,510 274.4% 6,097.4 503.1% South Africa 1,439 196.7% 167.6 55.4% South Korea 6,813 113.9% 1,215.0 260.6% Sweden 5,687 86.9% 9,191.6 134.6%

UK 14,744 84.6% 34,340.0 218.9%

Note: The European Union includes Austria, Belgium, Denmark, Finland, France,

Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain,

Sweden, and the UK.

27 Datamonitor. Global Pharmaceuticals, December 2011, with separate country reports issued from December 2011 and January

2012.

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Note: Intra - exports for the E.U. nations and China are included in the levels of exports

Source: Pharmaceutical Net Output from the National Science Foundation, 2012 for

Science and Engineering Indicators; World Trade Organization for Export Data

In innovation activity, as measured by medical science publications, medical science patents, and

biopharmaceutical-related venture capital funding, the U.S. currently has an especially strong

share of worldwide activity. In particular, the U.S. accounted for 66 percent of the world‘s

biopharmaceutical related venture capital funding in 2010, suggesting that the U.S. has a

substantial advantage in its more established capital and entrepreneurial development

infrastructure. The U.S. innovation strength also remains strong in medical science, where the

U.S. represented 47 percent of worldwide activity in 2010. The rest of the world seems to be

challenging the U.S. in one notable area—medical science publications — suggesting that other

nations are laying the foundation of knowledge and discovery needed to advance

biopharmaceutical innovation.

In terms of growth rates for innovation, similar to economic activity, the U.S. has grown in

scientific publications, patents, and venture capital funding since 2000, but it is not keeping pace

with world growth rates in these areas, demonstrating that other nations are moving forward

aggressively. A closer examination of medical science publications suggests that China and

Brazil have been emphasizing growth of their academic health research activities over the past

decade, with each more than doubling its output of medical science publications. Meanwhile, in

patents, South Korea and Israel crossed the 1,000 patent level in medical sciences in 2010 and

realized strong growth over 2000 to 2010. In biopharmaceutical8 related venture capital funding,

emerging nations, such as Brazil and China are laying the groundwork of a venture capital

industry, making enormous gains from 2000 to 2010 to put their nations on the map of

venture-backed new company formation in biopharmaceuticals. By contrast, more developed

nations across the E.U. and Japan recorded a significant decline in biopharmaceutical-related

venture capital from 2000 to 2010.

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Table 2.2.2 Biopharmaceutical Innovation Activity Measures by Country

Medical Science

Publications

Medical Science

WIPO Patents

Biopharmaceutical-related

Venture Capital

Investment (US$ Million)

Country 2010

Level

Percentage

Change

2000–2010

2010

Level

Percentage

Change

2000–2010

2010

Level

Percentage

Change

2000–2010

World 179,021 15.6% 34,151 64.4% $12,478 15%

United

States

58,664 10.6% 15,932 54.1% $8,229 5%

European

Union*

61,774 4.0% 10,518 47.7% $1,710 -9%

Australia 4,960 29.9% 493 44.6% $98 -31%

Brazil 3,131 167.4% 186 353.7% $189 57,103%

Canada 7,356 25.0% 843 1.8% $862 87%

Chile 403 29.2% 26 44.4% – -100%

China 7,429 373.0% 856 48.9% $491 6,649%

France 6,100 -12.5% 1,939 73.9% $370 108%

Germany 11,779 -0.2% 3,014 31.7% $399 -50%

Ireland 614 41.5% 199 41.1% $54 889%

Israel 1,602 -7.8% 1,037 141.2% $197 8%

Italy 7,698 22.1% 881 75.8% – -100%

Japan 10,666 -20.1% 2,729 106.3% $7 -50%

Russia 153 -25.1% 157 -10.8% – –

Saudi

Arabia

503 51.5% 16 1,500% $12 -65%

Singapore 521 14.1% 162 800% $8 –

South

Africa

4,227 226.5% 76 46.2% $89 21%

South

Korea

546 7.4% 1,232 592.1% $48 -53%

Sweden 2,959 -10.4% 534 8.3% $2 –

United

Kingdom

12,518 -10.6% 1,897 -2.0% $370 108%

Sources: National Science Foundation, 2012 Science and Engineering Indicators for

Medical Science Publications.

Thomson One for Venture Capital Funding in Biopharmaceutical-Related

Technologies.

WIPO Medical Science Patents, World Intellectual Property Organization.

The recently released ―2014 Global R&D Funding Forecast‖ issued by Battelle in collaboration

with R&D Magazine reported that life sciences research and development remains under pressure

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from expiring patents and the lower productivity of research activities in light of the rising

complexity of innovation in drug development. From 2012 to 2013, world R&D in life sciences

declined, and Battelle forecasts only a modest growth of 3.1% in 2014. While there is even more

uncertainty in the U.S. due to the recent enactment of health care reform and its focus on cost

effectiveness, the U.S. remains the world leader with 46% of the world‘s life science R&D. A

survey of U.S. industry research executives, meanwhile, points to the challenge of growing

relationships with U.S. companies. Nearly 60% of the life science industry representatives

reported their companies have no plans for specific foreign engagement, while only 20% are

planning new R&D facilities outside of the U.S. and a mere 7% expect to expand existing foreign

operations over the next year.

$184.2 $197.7 $195.3 $201.3

$84.5 $91.1 $90.6 $92.6

$0

$50

$100

$150

$200

$250

2011 2012 2013 2014

Ind

ust

rial

R&

D S

pen

din

g, B

illio

ns

U.S

. $

Global U.S.

Source: Battelle and R&D Magazine, ―2014 Global R&D Funding Forecast‖

Figure 2.2.1 Industrial R&D Spending Globally and by the U.S.

2.2.2 Investment Trend of Japanese Bioindustry Companies and Institutions

Japanese bio industries have invested and made establishments in countries such as U.S., Canada,

EU, and Singapore. Some also do business in India, where they have access to seasoned

researchers and scientist that have had a high level of education and experience in laboratories and

companies in developed countries. However, as a general trend, the appetite to invest overseas is

not too high, partly due to the huge time and cost to expand their businesses overseas, but also

from the need to put priority on maintaining and recovering the faltering operation rates in

existing manufacturing facilities.

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Examples of Japanese Bio Industries:

- Daiichi Sankyo Company, Limited has research facilities for antibodies for cancer in

Germany, research and development facilities for new low-molecular pharmaceutical

medicines in U.S., and transitional research for low molecular pharmaceutical products for

infectious diseases and auto-immune diseases in India. Daiichi Sankyo Company also

produces bulk pharmaceuticals in Ranbaxy Laboratories Limited, their fully consolidated

subsidiary in India

- Eisai Co., Ltd. has invested 5 billion Yen (approx. US$ 50 million) to establish research and

manufacturing facilities for bulk and intermediate pharmaceuticals in India.

- Kyowa Hakko Kirin Co., Ltd. owns research centers in U.S. and Singapore and

development centers in U.S., U.K., China, Korea and Hong Kong.

- Mitsubishi Tanabe Pharma Corporation acquired a Canadian pharmaceutical company that

is researching innovative production of vaccines using Virus Like Particles. Mitsubishi

Tanabe Pharma Corporation has also established manufacturing bases in China, Korea and

Taiwan.

- Takeda Pharmaceutical Company Limited has research and development centers in

Singapore and China. It also has several manufacturing facilities in China.

In Indonesia, some Japanese bio industries have established manufacturing facilities, due

to low wages and a large domestic market. Some examples can be found as follows:

- Mitsubishi Tanabe Pharma Corporation established PT. Tanabe Mitsubishi, a consolidated

subsidiary, in Indonesia in 1970. PT Tanabe Mitsubishi manufactures hypertension

medication for both Indonesia and its neighboring countries.

- Takeda Pharmaceutical Company Limited manufactures pharmaceuticals in Bekasi,

Indonesia for the domestic market.

- Mitsubishi Corporation Life Science Limited has factories in Indonesia to produce nucleic

acid, carrageenan and sorbitol.

- Bridgestone has established a research facility near some rubber-tree foundations, and are

studying medicines to cure or prevent diseases in rubber trees.

On the other hand, there are not so many Japanese bio industries that have established research

and development facilities in Indonesia. Interviews conducted revealed that bio industries will

seek locations where high-quality researchers, infrastructure and research grants are available.

The interviewees were of the view that neighboring countries such as Singapore and Thailand are

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more attractive relative to Indonesia on such issues. A few companies pointed out that the results

of Bio-science researches could easily be replicated if samples were removed from the site, and

therefore, high information security would be a critical requirement. Such companies found it

difficult to justify conducting sensitive R&D outside of Japan.

2.3 Best Practice of Successful Cluster Development Overview

Biosciences and associated industries are among the most actively pursued economic clusters by

governments and economic developers globally. The reasons are many, but chief among them

are:

-Biosciences represent a highly active area of scientific inquiry with a high volume of

innovations and novel technological advancements occurring that provide significant

opportunities for commercialization and business development.

-Bioscience products, especially medicines, but also other specialty products, are high-value

and are in high demand in global markets. Products produced by life-science clusters will

typically be export earners for their locations.

-Bioscience industry activity can add significant value to local bioresources generated via

natural ecosystems, agriculture, forestry and fisheries.

-Bioscience-oriented sectors in drugs and pharmaceuticals, agbioscience product development,

bio-chemical refining and other areas tend to be high-wage sectors – providing robust

family-sustaining wages to workers.

-Bioscience markets are extremely large and expanding. Rising global population in

combination with a global increase in middle-income consumers provide the basis for assured

and expanding demand for medicines, health products, food products, fuels and other

biobased products.

Bioscience is such a broad and deep field of science and technological advancement that there

exist a large-range of niches within bioscience which regions can specialize in and exploit.

Because of this breadth of opportunity, distinctive bioscience clusters can be identified across the

globe and much can be learned from the experiences of specific locales. Opportunities exist in

food and agriculture, in industrial bioproducts, in drugs and biologics, in environmental products,

biosecurity products and many more arenas.

Indonesia with its large-population (generating demand), its stock of natural- and bio-resources

(providing a highly flexible biomass production environment), and its base of research

institutions (in universities and national labs) provides a location rich in opportunity for

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bio-cluster development. Research reported herein notes that there are opportunities in three

major meta-theme areas for Indonesia:

-Agriculture and Value-Added Food

-Biofuels and Biorefinery Products

-Biopharmaceuticals, Natural Products and Functional Nutrition Products.

In this section of the report Battelle profiles some lessons-learned from global clusters active in

the three platforms of relevance to Indonesia. First, Battelle presents an overview of the general

characteristics of clusters active in these platforms, and then further detail is provided via some

specific case-study examples using a table-based summary format.

2.3.1 Agriculture and Food Oriented Clusters

(1) General Characteristics of Agbiosciences Oriented Clusters

Food and agriculture (agbioscience) clusters are typically focused in one or more of three primary

focus areas: 1) development of inputs and technologies to improve primary agriculture (especially

crop and livestock yield); 2) development and dissemination of optimized agronomic practices

to improve domestic agriculture, and 3) development of value-added food, feed, fiber and

industrial products from agricultural resources. Within these general areas, clusters of

innovation around the world will then tend to focus on enhancements to their system focused on

their local or regional agronomic characteristics.

A key characteristic shared by major agbioscience cluster locations globally is the presence of one

or more major research universities with a focus on food and agricultural sciences, or a

government or major non-profit research institution. Typically this will involve an institution (or

institutions) having the full spectrum of infrastructure required to advance modern plant or animal

bioscience, including (but not limited to):

-Life science laboratory facilities, equipped to facilitate basic through translational science

inquiries. Increasingly this requires high quality resources for molecular biology, advanced

genomics and proteomics – in addition to traditional wet-lab resources.

-Specialized resources focused on the growth and development of plants and livestock.

Including climate-controlled plant growth chambers, soil and sample preparation facilities,

secure greenhouse facilities, livestock housing units (for both large and small animals) and

biosecurity infrastructure (if dealing with pathogens or invasive species).

-Facilities for value-added product development and pilot-scale production of value added food,

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feed or industrial biomass-based products. Including food industry pilot plant equipment to

facilitate work such as basic milling, advanced food ingredient processing, value-added food

product formulation, sensory labs and other specialized infrastructure.

-External experiment station or university-farm facilities for field-trials. Such facilities may

also be used for foundation seed production and for income-generating production agriculture

activities

-And, increasingly, locations suited to industry-university partnerships and the

commercialization of institutional and industry agbioscience innovations. These range from

co-labs and incubation facilities, through to full-scale research parks.

(2) Case-Study Examples of Agbiosciences Oriented Clusters

Table 2.3.1 Case-Study Examples of Agbiosciences Oriented Clusters

Saskatoon, Canada Melbourne, Australia Kannapolis, North Carolina, USA

Description A defined cluster of university (University of Saskatchewan) and Canadian government labs. Oilseed and grains focus, plus livestock focus in infectious diseases and vaccines.

AgriBio is a world-class shared agbioscience facility developed by LaTrobe University and the State of Victoria Department of Primary Industries

A joint corporate and multi-university research campus (350 acres) specifically focused on food and agriculture

Focus Well-known in plant molecular biology. A focused agenda on semi-arid regions, and taking a ―prairie systems‖ approach to soil and water conservation, climate adaptation, pest control, crop and livestock development, and crop management.

Plant (primary crop and forage) improvement and livestock improvement.

Nutritional enhancement and value-added foods for health.

Corporate Relationships

Key relationships with multiple corporations, including significant relationships with Bayer CropScience and Dow AgroSciences.

Large scale sponsored R&D engagement by Dow AgroSciences and other domestic and multinational agbioscience companies. Additional relationships with Bayer Crop Science, DuPont-Pioneer, Hexima and others.

Multiple food and agribusiness company research labs (including Dole, Monsanto, and General Mills) located on a purpose built campus. Access to university/industry collaborations on-site.

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Saskatoon, Canada Melbourne, Australia Kannapolis, North Carolina, USA

Relationships with producer commodity groups also, such as Dairy Futures.

Government Engagement and Incentives

Provincial government responsible for development of co-located research park.

State of Victoria a primary investor in the development of the AgriBio complex.

Generous IP terms, granting international IP ownership, provided for international companies sponsoring research.

Primarily funded by commercial investment and philanthropy – especially through the direction of David H. Murdock, owner of Dole Foods. State universities have developed branches and research labs on site. State funded North Carolina Biotechnology Center helps promote and provide access to various state incentives and workforce development programs.

Commercialization Infrastructure and Shared Facilities

Provincial government operates co-located ―Innovation Place‖ a 78 acre research park chartered as a separate corporation. Provides flexible lease terms, wet-lab equipped multitenant buildings, greenhouse space and growth chambers. Facilitates university-industry partnerships. Very successful with 177 tenants/clients, 23 buildings and employment of 3,700 personnel. 75% are local Saskatchewan companies.

State-of-the-art genomics and associated resources for plant and animal improvement research. Co-located greenhouse facilities and biosecurity facilities. Dedicated space set-aside for industry co-location in AgriBio building and adjacent research park.

Purpose designed to foster collaborations across industry and academic labs.

Structured to provide: research collaborations and partnerships; space to host conferences, seminars, and workshops; shared-use facilities with advanced equipment and instrumentation; plus wet lab and Class A office space to lease or build-to-suit.

Workforce Assets

Co-located on university campus with access to undergraduate and graduate-students

Co-located on the Bundoora campus of La Trobe University with direct access to undergraduate and graduate students. Plus relationships with other Victorian universities.

On-site community college satellite facility. Active research labs of multiple universities with engaged graduate students.

On-site North Carolina Biotechnology Center facilitates access to state

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Saskatoon, Canada Melbourne, Australia Kannapolis, North Carolina, USA

programs in customized job training for companies.

Source: JICA Study Team

It should be noted that agbioscience-focused clusters have been developed not-only around

universities, but also via development of freestanding research institutes (such as the Danforth

Plant Sciences Center in Missouri USA and the Noble Foundation in Oklahoma, USA). The

BioResearch and Development Growth Park at the Donald Danforth Plant Science Center in St.

Louis, Missouri, U.S. allows tenant companies to access core facilities at the Danforth Center,

including greenhouses, growth chambers and advanced microscopy facilities at a discounted rate.

Plans are for three buildings reaching a total of 450,000 sq. feet. (there is currently one building of

110,000 sq. ft.). Several other U.S. universities are operating major food product development

and pilot plant facilities focused on joint industry/university research and applied product

development. Examples can be found at The Ohio State University, the Center for Crops

Utilization Research at Iowa State University, Kansas State University and the University of

Minnesota (to name a few).

2.3.2 Biorefining and Biofuels Oriented

(1) General Characteristics of Biorefining and Biofuels Oriented Clusters

This is a still developing space, and there are relatively few distinctive clusters of biofuels and

biorefining excellence that have emerged globally. That said, there are several locations that are

generally viewed as leaders in this emerging industry. In almost every case the biorefining

clusters that have emerged are focused on the conversion of local biomass resources into

value-added industrial and fuel products. In this regard they are quite similar to the agriculture

and food clusters in structure and focus – seeking to add-value to a domestic or regional/localized

bioresource. Examples include:

-The Midwestern/prairie states in the United States - such as Iowa, Minnesota, South Dakota

and Nebraska - which have had an initial focus on the conversion of starches (primarily from

corn) into ethanol via fermentation pathways. These locations are also active in the

development of next generation biofuels processes for the conversion of lingo-cellulosic

materials (including crop residues and dedicated energy crops) into biofuels.

-Nations and regions with a concentration of sugar-cane operations (most notably Brazil),

focused on conversion of sugar cane into ethanol and other biorefinery products via

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fermentation (biotechnology) processes.

-Locations with significant production of oil-bearing crops (such as the U.S., Canada and

Europe) for development of biodiesel, downstream refined-oil products and oleochemical

products.

There are also some locations, albeit a limited number, that are more focused on next generation

biofuel and biorefining production technologies that the specific conversion of local biomass into

fuels or biobased products. These locations are interesting in that they are leveraging previous

biotechnology R&D expertise to new applications in biofuels or are existing hubs of companies

that are pivoting to biofuel opportunities. An example here is Denmark, which as home to

leading enzyme companies Novazymes and Genencor, is on the leading edge of work in

enzymatic processing of lingo-cellulosic biomass. Similarly, San Diego (a global medic al

biotechnology hub) has also developed significant university and industry R&D expertise in

biofuels.

In general, cluster initiatives in biofuels and biorefining tend to focus around certain aspects of the

biomass to converted product supply chain –covering areas such as:

-The development and enhancement of enhanced plant (or algae) biomass with desired

characteristics in terms of yield, phytochemical/oil content, downstream processability,

adoption top local growing conditions and stresses, etc. This requires expertise in plant

biology, molecular biology, plant breeding and genomics. This focus requires lab-to-field

trial infrastructure similar to that identified under food and agriculture above.

-The development of techniques and technologies for biomass harvesting, biomass

densification and transportation (e.g. early processing steps to reduce the bulk-density of the

biomass for shipment purposes – such as via pyrolysis to bio-oil, crushing of oil-seeds, or

pelletization of lignocellulosic biomass). Thins requires expertise in mechanical and

agricultural engineering, chemical engineering and, increasingly, biotechnology.

-Development of downstream bioprocesses and chemical engineering for conversion of

biomass in to value-added fuels, chemicals and materials (typically via one of three major

platforms: thermochemical, biochemical/fermentation, and catalytic chemical reactions).

This requires institutions and industry with expertise in chemistry, chemical engineering,

process and industrial engineering, and biorefinery operations. It also requires access to

pilot-plant and scale-up facilities able to process lab-developed chemicals and products at a

scale sufficient for downstream customers to test the potential product.

(2) Case-Study Examples of Biorefining and Biofuels Clusters

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Table 2.3.2 Case-Study Examples of Biorefining and Biofuels Clusters

Iowa, USA Brazil Colorado, USA

Description State Government, private industry and state university collaborations focused on building a world-class location for bioenergy and biobased product development and production.

A national industry cluster in bio-based ethanol production.

A cluster of national lab, university and industry resources coming together to build a biofuels and biorefining cluster in Colorado.

Focus Initial focus on building a significant base of first generation biofuels production facilities (ethanol from corn and biodiesel from soy). Complementary research focus on next generation biofuels, integrated biorefinery operations and value-added biobased chemical products.

Production of ethanol from sugar cane and advanced biotechnology and chemical engineering techniques to fully utilize sugar cane biomass.

Focus on maximizing production efficiencies.

Next generation biofuel technologies using plant biomass and algae.

Corporate

Relationships

Production sector in Iowa is corporate or farmer cooperative owned and operated.

There are 35 dry mill and 7 wet-mill ethanol processing plants in the state, plus multiple biodiesel operations and integrated biorefineries are developing.

The Brazilian experience has been government and corporate led, rather than university directed. Industry has been the primary investor, responding to demand signals stimulated by government policies (see below). Ability to implement actions greatly facilitated by size of semi-public PetroBras multinational corporation.

Multiple engaged companies. Formal engagements through the Colorado Renewable Energy Collaboratory, with key engagement by: Chevron; Cool Planet Energy Systems, Gevo, Rentech, Shell Global Solutions and Sundrop Fuels.

Government

Engagement

and Incentives

Significant State of Iowa support programs, including matching grants program for industry-university collaborations.

State of Iowa operates multiple incentive and industry support programs, usually in the

High mandatory national blend requirements (20-25%) for biofuels stimulates domestic demand.

Government fleet vehicles early adopters, including 100% ethanol vehicles. Plus promoted Brazilian

Presence of the U.S. Federal government‘s national lab focused on renewable energy (NREL) with large-scale specialized infrastructure, pilot plants and a new Integrated Biorefinery Research Facility. Also operates the

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Iowa, USA Brazil Colorado, USA

form of loans and/or forgivable loans, based in part on job creation, capital investment, the ability to meet certain wage standards, quality of employment, and economic benefits for the state and local community. Also operates a tax credit program for ethanol/biofuels production.

State biofuels infrastructure grants are available to help install alternative fueling infrastructure. Also provide alternative fuel vehicle demonstration grants.

manufacturing of flexible fuel vehicles.

Thermochemical User Facility.

Focused research programs at three public state universities (University of Colorado, Colorado State University and the Colorado School of Mines). These institutions, together with NREL and industry have formed the Colorado Renewable Energy Collaboratory.

State cleantech seed fund. Clean Technology Discovery Evaluation Grant Program. State operated Biofuels Research Grants. Plus state legislation to encourage biofuels/alternative fuels usage. State agencies required to purchase renewable/flex-fuel vehicles.

Commercializa

tion

Infrastructure

and Shared

Facilities

BEACON scale-up facility for biobased products development. Center for Crops Utilization Research pilot plants. Co-lab space in ISU Plant Sciences Institute and adjacent to campus Research Park with incubator facilities.

Significant innovation occurring within private industry labs without the need of extensive public infrastructure investment.

Several private and government/university R&D institutes provide support.

User facilities at NREL (including major pilot plant facilities) and access to university facilities under user agreements.

University research parks and incubator facilities.

Workforce

Assets

Co-located on university campus with access to undergraduate and graduate students.

Custom commercial biorefinery workforce education programs

The Brazilian government claims that the development of the ethanol industry has generated 1 million new jobs in the country.

The growth of the

Multiple engaged universities.

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Iowa, USA Brazil Colorado, USA

developed by Iowa Community College system.

industry has outstripped the ability of Brazil to supply domestic labor. Currently migrant labor used in the industry is over 200,000 persons.

Increasing use of mechanized planting and harvesting equipment led to programs to retain harvesters for downstream processing jobs.

Source: JICA Study Team

A notable emerging trend in North America is the repurposing of existing industrial chemicals

research facilities and assets to serve the needs of biofuels and biorefining R&D, piloting and

scale up. Three recent examples of this trend can be found in the Province of Ontario in Canada;

the State of West Virginia in the U.S., and the State of Michigan in the U.S.:

-In Ontario a former Dow Chemical research facility has been taken over by the City of Sarnia

and the County of Lambton and renovated to create the Bioindustrial Innovation Center. The

Center is on the Sarnia Lambton Campus of the University of Western Ontario and is managed,

under contract, by the University. The facility houses labs and pilot plant facilities and

industry is able to locate in the building to conduct research and pilot scale projects. A large

regional chemicals industry cluster helps link researchers and new start-up enterprises to

existing companies and scale-up infrastructure.

-In West Virginia, the State has taken ownership of the former Union-Carbide Research

Campus in South Charleston. This sprawling R&D complex includes offices, lab space,

multiple pilot-plant and scale-up facilities suited to a range of chemical and fuel development

projects. A non-profit chemicals R&D company, staffed by ex Union Carbine/Dow

technicians and engineers, is operating on the site and managing projects for clients using the

pilot plant facilities. The local community college and Marshall University are also operating

education programs on the site and providing customized job training.

-In Michigan, a 138,000 square foot building was donated to Michigan State University by

Pfizer Corporation. MSU has installed its Bioeconomy Institute into the building, complete

with offices, laboratory space and pilot plant facilities suited to a range of chemical

development work. The plant contains approximately 30 reactors ranging from 40 to 4,000

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liters together with centrifuges, driers, filters, condensers and other shared-user resources.

The building contains dedicated business incubator space, and the Institute is focused on three

themes in specialty chemicals, biomaterials and biofuels.

2.3.3 Biopharmaceutical Products Oriented Clusters

(1) General Characteristics of Biopharmaceutical Products Oriented Clusters

Work for Indonesia is focused on development of biopharmaceutical and functional nutrient

biomedical platforms (as opposed to, say, medical devices or health care technologies). As such,

the examples discussed below are focused on locations that are providing successful in

developing and attracting significant biopharma R&D and production investments.

In general, locations that are successful in biopharma operations share the following

characteristics:

-For those engaged in biopharma R&D and associated innovation they will typically be home

to one or more major biopharmaceutical corporation research locations and associated

spin-out enterprises, and/or home to major academic institutions (especially academic medical

centers with a co-located medical school) with a track-record in biomedical research. With

university-driven clusters they will often be focused on particular classes of drug products

(such as biologics, small molecule drugs, vaccines, diagnostics, etc.) or on products focused

towards particular applications or diseases (e.g. cancer therapeutics, animal vaccines,

infectious disease treatments, psycho-pharmaceuticals, etc.).

-Strong focus on commercialization of university research discoveries and providing access to

risk financing for new product development and new enterprise formation. Often tax

incentives will be used to advance R&D, commercialization and risk capital.

-They have developed a sophisticated system of assuring research labs and industry production

operations have access to a skilled workforce, trained in specialized GLP and GMP processes.

-They provide access to specialty service providers in provision of clinical trial services,

regulatory affairs, intellectual property protection and legal affairs.

-They provide an operating environment that is stable (reducing risks) and conducive to

protecting the intellectual property rights of innovative biopharmaceutical companies.

-It is common for there to be associated research park developments affiliated with universities

and research institutions given the need for access to specialized wet lab space that is typically

not provided by the commercial real estate market.

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Beyond the innovative biopharma sector clusters, there are also international clusters focus on the

far-less innovative production of generic drugs, vaccine, and an emerging bio-similars space.

Also there is the production of excipients – materials that are not the primary therapeutic

compound contained within a biopharma product.

(2) Case-Study Examples of Biopharmaceutical Products Oriented Clusters

Table 2.3.3 Case-Study Examples of Biopharmaceutical Products Oriented Clusters

Singapore Jordan Indiana, USA

Description Government-led focused strategy on growing biopharmaceutical industry in Singapore.

An emerging biomedical cluster supported by combined public and private efforts across pharmaceutical, contract research, hospitals and universities.

A statewide biosciences industry cluster development strategy.

Focus Singapore has also sought to attract the R&D operations of biopharmaceutical firms and support new firm formation through a comprehensive strategy of investing invested heavily in research and development (R&D) in concert with industry, undertaking significant workforce development initiatives, and providing commercialization support.

Jordan has enjoyed a growing biomedical cluster fueled by government policies to embrace economic reforms to integrate into the world economy, including enhancement of world IP standards. This focus on integration into the world economy has included international accreditation of hospitals.

In 2002, Indiana launched a focused, statewide life sciences cluster development strategy to realize its potential in the biosciences. A strategic plan developed by Battelle set out a comprehensive and integrated action agenda focused on: • Creating stronger

public-private partnerships

• Focusing investments in key research areas

• Supporting start-up companies

• Ensuring venture capital is available

• Addressing the lack of specialized facilities

• Building a skilled, life sciences workforce

• Raising the national reputation of Indiana

Corporate More than 30 companies, many

Long-standing, home-grown generic

Established industry base in

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Singapore Jordan Indiana, USA

Relationships well‐known multinational biopharmaceutical companies, have located R&D operations in Singapore.

This has enabled Singapore to enjoy strong industry growth, with pharmaceutical output increasing by 274 percent from 2000 to 2010.

pharmaceutical manufacturing industry of more than a dozen firms that were able to adapt to higher IP standards and are now very export oriented.

In last decade, a base of contract research organizations (CROs) for bioequivalence testing of generics has developed, which is now supporting a growing base of clinical testing of new drug candidates.

Also, Jordan has benefited from continued growth in medical tourism, led by its private hospitals, major academic hospitals, and the Royal Medical Services, which have obtained international accreditation.

biopharmaceuticals, led by presence of Eli Lilly and Roche, along with the largest orthopedic medical device cluster in the U.S. with companies such as Zimmer, DePuy and Biomet.

Since implementation of strategy, Indiana has experienced strong job growth well outpacing the nation.

Plus, robust new firm creation with 220 life science startups since 2004

Government

Engagement

and

Incentives

As of 2010, Singapore‘s annual expenditures in

biomedical sciences R&D exceeded S$1 billion

(US$1.25 billion). Singapore has achieved its goal of R&D expenditures of 2.5 percent of GDP and has now advanced the goal to 3.5 percent by 2015.

Extensive use of tax incentives, with many targeted towards innovation and R&D activities.

Establishment of selected research centers at Jordan Universities.

Development Areas Law of 2008 set out aggressive approach to attracting foreign investment for biomedical industries through development of mixed use educational and high tech zones in Jordan with significant incentives.

New tax credits – R&D credit and sales tax exemption, VC Investment, Patent Income Exemption

Focused growth of life sciences research capabilities with $600 million+ in major philanthropic grants to life sciences research universities and institutes

Commercial-

ization Infra-

structure and

Created a series of research institutes and industrial consortia organized outside the university sector and

First Middle Eastern nation to implement Trade-Related Aspects of Intellectual Property (IP) Rights (TRIPS) as it

Substantial levels of venture capital investment with $277 million invested in life sciences firms since

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Singapore Jordan Indiana, USA

Shared

Facilities

focused on industry-driven applied research.

Created the Biopolis Research Park, as signature place in which to co‐locate the research institutes with international industry.

A comprehensive commercialization effort successfully implemented with: 1) a dedicated technology transfer and commercialization arm to serve the research institutes; 2) initial proof-of-concept funding to validate technology as well as follow-on prototype funding; and 3) new enterprise counseling.

joined the World Trade Organization in 2000

Nascent infrastructure being put in place to support business formation and growth, such as for incubation and entrepreneurial support, largely in partnership between Jordanian government and foreign donors. Plus, upgrading technology transfer activities at universities, with support from the EU, to develop common IP policies and training for university staff in managing technology transfer.

2004, particularly at the seed stage.

Creation of IU Health bringing together IU Medical School and Clarian Healthcare System, has advanced a stronger capacity in translational research.

Workforce

Assets

Singapore works on parallel tracks of recruiting talent at all levels and developing indigenous talent. Makes extensive use of

scholarships and fellowships to foreign universities to grow its local base of researchers.

A strong theme of Singapore‘s talent programs is the development of physician‐scientists. Best known is Singapore‘s

flagship partnership with Duke University established in 2005.

Strong pipeline of talent through significant growth in university graduates in biomedical and clinical medicine fields over the last decade.

Creation of specific industry focused organizations for orthopedics, drug development, sports medicine, health IT and personalized medicine able to advocate for specialized education and training programs by colleges and universities.

Source: JICA Study Team

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2.4 Batam Polytechnic

2.4.1 Outline of Batam Polytechnic

Batam Polytechnic (Politeknik Negeri Batam: Polibatam) is the only State College in the area of

vocational education on trade and free ports of Batam, Bintan and Karimun in Riau Islands

Province. Besides located at one of the central areas of national economic growth, Polibatam is

also located in the leading edge region and the outer region of the Republic of Indonesia . The

rapid growth of the industry in Batam creates high demand for professionals and skilled workers,

so it is reasonable for the Batam Authority initiated the establishment of Polytechnic education

institution whose mission is scored for the needs of industrial workers in Batam.

At first, Polibatam is a private higher education under the Education Foundation established by

Batam Authority, Bandung Institute of Technology (ITB), Government of Batam City and

University of Riau. Along with the performance development and its achievements over a decade,

on October 18, 2010, the Indonesian Government through the Minister of National Education

Regulation No. 26 of 2010 stipulated that Polibatam officially became state college namely

Batam Polytechnic .

Application of Teaching Factory in Polibatam, which is a real problem-based learning in the

industry, is also expected to enrich the students' skills, confidence and real working habits. There

are four majors, Business Management, Electrical Engineering, Mechanical Engineering and

Informatics Techniques. Each department has a laboratory to improve the competence of

students28

.

2.4.2 Batam Techno Park

Development idea of Batam Techno Park begins of discussions between Batam Polytechnic and

business groups regarding the application technologies in the industrial city of Batam. Following

up the idea, Directorate of Goods Traffic of BP Batam (Badan Pengusahaan Batam: BIFZA

(Batam Indonesia Free Zone Authority)) in cooperation with the central government such as

Ministry of Research and Technology, Coordinating Ministry of Economic Affairs, Riau Islands

Province, ITB and Batam Polytechnic plans to construct facilities and technology innovation

center called Batam Techno Park. The concept is also in the framework of supporting engineering

and accountancy programs of the polytechnic, so that teaching factory activities could be a benefit

for the students, lecturers and SMEs by applying the technology being developed.

This plan has been discussed in both, central and local level, even BP Batam has also held

28 http://www.polibatam.ac.id/ ; www.bpbatam.go.id and other related articles

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discussions with UNESCO - Sector STP (Science Technology Park) to get input in terms of the

formation of the techno park. Batam Techno Park is a vehicle that is prepared to bring innovation

through synergy of academia, business, and government. This vehicle is also intended to enhance

the human resource capacity, as well as to foster new technology-based businesses. The Techno

Park will be doing a lot of research for the development of the animation industry and the

electronics industry in Batam. It is expected in the future to boost the growth of small industries

there.

On September 13, 2013, the Minister of Research and Technology launched Batam Techno Park

in Batam Polytechnic Auditorium. In the near future, Government of Riau Province, Government

of Batam City and BP Batam will sign the MoU related to the construction of facilities. For

development of technology, strong commitment of related ministries, governments and

organization will be expected.

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Chapter 3. Legal Framework

3.1 Legal Background

3.1.1 Legal Basis of the Project

JICA New Academic Research Cluster (NARC) Study Team has been conducting the survey on

the legal basis of NARC project. Since many of Research and Development (R&D) activities are

not profitable enough to be conducted as pure private business, the government

supports/incentives are inevitable to promote R&D activities. The main role of this project is to

promote R&D activities by providing decent R&D facilities for co-work between public and

private research institutions/companies; therefore, it is important to select the legal basis which

makes it possible for government to provide supports/incentives for the

development/construction of R&D facilities. In order to acquire government supports/incentives,

JICA Study Team proposed two project scheme alternatives in Chapter 8. One is the PPP Scheme

with government subsidy and another is Hybrid Scheme which is the combination of public

investment and private investment. The legal basis for the above-mentioned two project schemes

alternatives are as follows:

(1) PPP scheme, based on the Presidential Regulation (―PR‖) No.67 of 2005 (which has been

amended by PR No.13 of 2010 and PR No.56 of 2011) (herein after ―PR67/2005PPP

Regulation‖),

(2) Hybrid scheme, Presidential Regulation No.54 year 2010 on Government Procurement of

Goods/Services (Hereinafter ―PR54/2010‖) and Government Regulation No.6 year 2006 on

State/Regional Assets Management (hereinafter ―GR6/2006‖).

The legal issues regarding to PPP Scheme with subsidy and Hybrid Scheme shall be discussed in

3.2 and 3.3. It is also important to provide the incentives to R&D activities by itself in order to be

more attractive for the potential tenants of NARC facility and to be more competitive among the

neighbor countries. The incentives for R&D activities shall be discussed in detail in Chapter 4.

3.1.2 Legal Capacity of BPPT and State Universities as NARC Project Implementation

Agencies

(1) Applicability of BPPT as Contracting Agency

BPPT is Non-Ministrial Government Agency (Lembaga Pemerintah Non-Kementerian or

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―LPNK‖) (PD103/2001) under coordination of Ministry of Research and Technology

(MEN-RISTEK). Based on Article 60 of PD 103/2001, BPPT has authority, as follows:

1) Preparation of national plan at the macro level related to its sector

2) Preparation of policy in its sector to support development at the macro level

3) Stipulation of information system in its sector

4) Other authority in accordance with laws and regulations, such as preparation and

implementation of certain policy in assessment and application of technology

5) Submit recommendation of application of technology and conduct audit of technology

The main mandate of BPPT is stipulated under PD 103/2001. Pursuant to mandate of BPPT as

described in section D, the statute of BPPT does not expressly specify that BPPT is mandated to

carry out R&D infrastructure. However, it seems to be that this mandate is implied, because BPPT

is generally authorized to carry out assessment and application of technology29

.

(2) Applicability of Sate Universities as Contracting Agencies

1) Transition of Legal Status of State Universities

Since 1989, the Status of State Higher Educational Institutions including state universities in

Indonesia has been transited into 4 forms as follows:

a) PTUPT (Unit PelayananTeknis/ Technical Implementation Unit);

b) PTBHMN (BadanHukumMilik Negara/ The State-Owned legal Entity);

c) PTBHP (BadanHukumPendidikan/ Education Legal Entity);

d) PTBLU (BadanLayananUmum/ Public Service Entity); or

e) PTBH (BadanHukum/ legal Entity) (Optional based on evaluation)

In 1999, considering the increasing operation costs and needs for implementation of main

functions, the status of State Higher Educational Institutions transited from PTUPT to

PTBHMN by GR 61/1999. PTBHMN is an independent legal entity which can conduct

business activity that would support the main function of the State Higher Education.

In 2003, the autonomy of State Higher Educational Institutions was reinforced by replacing

PTBHMN to PTBHP through Law 20/2003 (later by Law 9/2009). The status of PTBHP

allowed State Higher Education Institutions to manage their income and expenditure

independently. This status raised pros and cons in the society. The societies who think that

the PTBHP status will make liberalization and capitalization of State Higher Educational

29 See APPENDIX 3-2 for legal comments.

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Institutions and will increase the cost of education raised the issue to the constitutional court

to convey their objection on PTBHP status of higher education.

After the process of review, this objection was accepted by the Constitutional Court.

Therefore, the law lost validity by the decision of Constitutional Court of Indonesia Number

11-14-21-126-136/PUU-VII/2009 dated March 31, 2010. This court decision makes the

government issue GR 17/2010 (amended by GR 66/2010 and GR 17/2010) to convert the

status of State Higher Educational Institutions to PTBLU whose autonomy is limited.

The law which provides the autonomy to the State Higher Educational Institutions was

again enacted on 10th August 2012 (Law 12/2012) which would convert the PTBLU to

PTBH30.

2) Current Legal Status of State Universities

After the issuance of Law 12/2012 on 10 August 2012, then on 28 August 2012 the national

government has issued Government Regulation No.74 of 2012 on Amendment of

Government Regulation No.23 of 2005 on Financial Management of Public Service Agency

(BLU) (herein after "GR 74/2012")31. GR 74/2012 has stipulated that financial management

in IPB and ITB are implementing financial management of BLU with status full BLU.

Article 37B of GR 74/2012 provides that all assets (including state assets that stipulated as

preliminary assets of IPB and Airlangga University) of IPB and ITB are transferred to

Ministry of Education and Culture (herein after "MEC"), in which the transfer of assets will

be further regulated under MOF Regulation.

Based on GR 74/2012, currently, status of IPB and ITB are full BLU. In Article 65

paragraph (2) of Law 12/2012 provides that national universities which implement financial

management of BLU have governance and authority of management in accordance with

laws and regulations on BLU.

Implementation of autonomy in universities may be given selectively from MEC based on

performance evaluation of BLU or by establishment of PTN-BH to produce high-quality

higher education.

Under Law 12/2012, universities have their own autonomy to manage its agencies by

themselves as implementation center of Tridharma. Autonomy of universities shall conduct

based on the following principles:

a) Accountability

30 See the APPENDIX 3-3 for the comparison between the transition statuses of State Higher Education. 31 The description of Applicability of State University as Contracting Agency was cited or summarized from the

Legal Review by HJ. See APPENDIX 3-2.

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b) Transparency

c) Nonprofit

d) Quality assurance

e) Effectiveness and efficiency

Elucidation of Article 63 of Law 12/2012 confirms the meaning of nonprofit principle that

universities conduct activity which have purpose not pursue profit, so then all result of net

income from such activity must be reinvested for universities to improve capacity and/or

quality of education service.

The main mandate of IPB and ITB as universities is stipulated under Law 12/2012. The

main mandate of IPB and ITB includes:

a) Development of capability and creation of character and civilization of nation in order to

educate dignified life of the people

b) Development of academic activity with innovative, responsive, creative, qualified,

competitive, and cooperative through implementation of Tridharma

c) Development of science and technology with regard and implement of humanities value

Law 12/2012 does not provide specific mandate for IPB and ITB to conduct R&D

infrastructure. The implementation regulation of Law 12/2012, which is currently under

preparation by MEC may prescribe the mandate of state universities.

JICA Study Team assumes the IPB and ITB as PTBH (Perguruan Tinggi Berbadan

Hukum/University with Legal Entity) would be given mandate including the development

of R&D facility as IPB is currently involved with the shopping mall business.

3) Consistency with RP 67/2005

The Government Contracting Agency (herein after ―GCA‖) is the contracting body to make

a PPP contract with private business entity. Also, the GCA has a responsibility to provide

necessary government support such as provision of land and VGF.

In this NARC project, both BPPT and the state universities are expected to be GCA.

However, the current PR67/2005 does not prescribe state universitiy as a GCA for PPP

project (Article 2 (1) and (2) of PR67/2005). If the state university cannot be a GCA, BPPT

shall be the only one GCA. In this case, the right and obligation of the project would be

shared only between BPPT and SPC under PPP contract. Separately from PPP contract,

BPPT would share the right and obligation with state universities based on the cooperation

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agreement32.

JICA Study Team believes that the most simple and reliable contractual structure should be

the structure that BPPT together with state universities shall would be GCA. Study Team

recommends the state universities to submit the proposal to amend PR67/2005 to include

state university as GCA for PPP project.

3.1.3 Legal Issues on Project Sites

(1) Utilization of Land of State for NARC BPPT Site

The land of NARC BPPT site is owned by the State. Regarding to the interview to BPPT, the right

to use the land is hold by RISTEK and shall be transferred to BPPT and/or a private company.

RISTEK need prior approval from MOF for the contribution of the land to a private company.

(2) Utilization of Land of State for NARC IPB Site

NARC IPB site is owned by the State and IPB is given the right to use the land. As mentioned in

3.1.2, IPB shall be given the autonomy in the form of legal entity (PTBH) based on Law 12/2012.

PTBH is regulated under Law 12/2012. Based on Article 65 paragraph (3) of Law 12/2012, PTBH

has governance and authority as follows:

1) Preliminary assets in the form of separated state assets except for land

2) Governance and independent decision making

3) Unit that implement accountability function and transparency

4) Rights to manage fund independently, with transparency and accountablity

5) Independent authority to appoint and dismiss of lecturers/education manpower

6) Authority to establish business entities and develop endowment fund

7) Authority to open, implement, and close study program

As shown in 1) above, the law indicates that no land will be regarded as owned by PTBH. IPB

also need prior approval from MOF for the contribution of the land to a private company.

(3) Utilization of Land of Bekasi Regency for NARC ITB Site

Based on the interview to ITB, the ownership of the land where NARC project is proposed to be

conducted is currently under Bekasi Regency. However, Bekasi Regency and ITB had the

agreement, ―Cooperation Agreement between Government of Bekasi District and Bandung

Institute of Technology about ITB Campus Development and Education Development Activities,

32

See 8.2 for the alternative project scheme and APPENDIX 3-2 for the legal review on each alternative structure.

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Training Research and Community Social Responsibility in Bekasi District (herein after

―Bekasi-ITB Agreement‖)‖ and ITB shall be given the right to use the land of Bekasi Regency

based on the Bekasi-ITB Agreement33

.

Article 13 of Bekasi-ITB Agreement prescribes that Bekasi Regency shall hand over the

management of land and building to ITB for the purpose of educational development activities,

training research and community service in Bekasi. However, it does not prescribe about

sub-leasing the land to the third parties. In order for a private company to use the land,

Bekasi-ITB Agreements should be amended before the procurement process would start.

Also, Bekasi-ITB Agreement prescribes that the ownership of the building on the land which

Bekasi lend to ITB shall be transferred to Bekasi Regency (Article 12 of Bekasi-ITB Agreement).

Therefore, when the private business entity builds the NARC facility on the site of ITB, the

ownership of NARC facility might be transferred to Bekasi Regency. Since the NARC project

assumes project finance from financial institution, it would be required to set the collateral on the

NARC facility. If the NARC facility were owned by Bekasi Regency, it would be difficult to set

the collateral on the NARC facility, which makes difficult for the private business entity to get

finance. ITB need to amend Bekasi-ITB Agreements in this issue as well to keep the ownership of

NARC for the private business entity during the project period.

3.1.4 Other Legal Issues

(1) Restriction of Foreign Investment

Foreign investment is prohibited or restricted for a certain sector in Indonesia. The list of sectors

which are prohibited or restricted is prescribed in PR 36/2010, which is called ―Negative List.‖

JICA Study Team visited BKPM on September16 2013 and sent the confirmation letter for the

relevance of NARC to the Negative List on Sep.24 2013. We received a tentative answer from

BKPM saying the NARC might be categorized as a ―Industrial Park‖ and there will be no

restriction for foreign investors. In another word, foreign investor can hold 100% of share of the

SPC which shall be established in NARC Project.

If the NARC project shall be conducted under SEZ law, the Negative List shall not be applied

except for the business fields that are reserved for small and medium companies and cooperatives

(Article 39 of Law 39/2009).

(2) Restriction of Foreign Borrowing

When the private company registered in Indonesia make a loan from overseas, the private investor

are required initial registration and monthly report to the Bank of Indonesia (12/24/PBI/2010,

33

See APPENDIX 3-4 for the concerned articles of Bekasi-ITB Agreement.

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12/19/Dint, 13/1/Dint).

(3) Overseas Remittance

Private company can send the cash to overseas without restriction, however, reporting to Bank of

Indonesia is required when sending over US$ 10,000.

(4) Restriction of Land Utilization by Foreign Company

There are three types of basic right regarding land.

1) Ownership (Hak Milik)

2) Right to construct (Hak Guna Bangunan: HGB)

3) Right to use (Hak Pakai)

It is prohibited for foreign companies to own the land in Indonesia, therefore, the project which

involves construction usually acquires HGB.

(5) Establishment of Special Purpose Company

PPP contract would possibly be made between public sector and Special Purpose Company (SPC)

which is most likely in the form of Perseroan Terbatas (PT: Limited Company). PT is the form of

the company which the shareholders have limited liability. The shareholders shall not have an

obligation for the debtor of the company (Corporate Law Article 3 (1)). Since NARC project

assume project finance, PT would be the most applicable as SPC.

There are two types of PT. One is open company (PT Terbuka) and another is closed company (PT

Tertutup). In case of closed company, the minimum shareholders are required as two (Corporate

Law Article 7 (1)) and minimum capitalization value is Rp.50,000,000. Shareholders can be

national or international companies.

(6) Dividend and Reserve

Dividend policy shall be decided in the shareholders meeting. Amount of dividend shall be based

on the number of shares; however, the company also can issue the preferred stock, which dividend

shall be given more preferably than common stocks.

The company is required to reserve the legal retained earnings until the total amount reach to the

20% of paid in capital (Corporate Law Article 70 (1)3). This is mandatory as long as the company

has cumulative surplus (Corporate Law Article 70 (2)).

3.1.5 Issues of Current Legal Status

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Since this kind of academic research based R&D Project is the first case in Indonesia, many legal

burriers need to be tackled, such as the implementation organization structure and land status

mentioned above. Moreover, R&D business mainly aims to create new technologies as well as

products, and not create direct benefit to the R&D business investor in the short term. Therefore,

commonly required strong government support both for financial and non-financial issues to

attract and accelerate R&D investment to value-adding national economic value and international

competitiveness.

3.2 Legal Issues on PPP Scheme with Subsidy

3.2.1 Applicability of PPP Regulation

PR 67/2005 is the basic regulation regarding to PPP in Indonesia and prescribes about the targeted

infrastructures, contracting agencies, possible government supports such as VGF and so on. The

NARC Project requires the government fiscal supports in order to attract more tenants from

industry by setting low tenant fee. Therefore, it is inevitable for the NARC project to receive

government supports such as VGF. VGF is the facility which would be available for the PPP

project under PR 67/2005.

PR 67/2005 does not prescribe ―Infrastructure for Innovation and R&D activity‖ as its targeted

infrastructure (Article 4(1) of RP 67/2005). Based on the legal review by Hermawan Juriarto

(herein after ―HJ‖), the list of infrastructures prescribed in PPP regulation is not conclusive.

However, HJ commented that Ministry of Finance most likely would not provide VGF unless

―Infrastructure for Innovation and R&D activity‖ would be listed in PR 67/200534

.

BPPT and JICA Study Team had a discussion with the officers from Directorate of Public Private

Partnership (PPP) Development, BAPPENAS (herein after ―PPP-BAPPENAS‖) on July 26 2013

regarding to the applicability of PPP regulation for the NARC project. BPPT and JICA Study

Team were recommended from PPP-BAPPENAS that BPPT should submit the proposal to

include ―Infrastructure for Innovation and R&D activity‖ as a targeted infrastructure in PR

67/2005 (herein after ―Amendment Proposal‖) to Committee on Policy for the Acceleration of

Infrastructure Development (KKPPI).

BPPT supported by JICA Study Team prepared the Amendment Proposal to KKPPI and

submitted it to KKPPI at the beginning of September, 2013. BPPT and Study Team were informed

that the concerned government ministries are currently collecting information for the amendment

of PR67/2005. The actual amendment of PR 67/2005 is scheduled in 2014.

34

See APPENDIX 3-1 for the Legal Review by HJ.

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3.2.2 Legal Issues on PPP Procurement

(1) Contents of Pre-Feasibility Study Required by PPP Regulation

PPP procurement procedure is prescribed in BAPPENAS Regulation No.3 of 2012 on The

Operational Guidelines Manual for The Implementation of Public Private Partnership in

Infrastructure Provision (herein after ―OGM‖) and its attachment (herein after ―OGM

Attachment‖).

Regarding to Article 4 of OGM, the PPP Project Development Cycle (the PPP Project Cycle) shall

be carried out in the following phases:

Planning of PPP Project

1) Preparation of PPP Project

2) Transaction of PPP Project

3) Implementation Management of PPP Contract

Article F. of OGM Attachment prescribes that the Pre-Feasibility study shall be conducted in 1)

Preparation of PPP Project, and the document generated during Project Preparation Phase

comprises of:

1) Report of the Preliminary Appraisal of Pre-Feasibility Study (the Outline Business Case)

2) Report of the Project Readiness

Report of Preliminary Appraisal of pre-Feasibility Study shall at least include:

1) Executive Summary

2) Introduction, covering

-Project‘s Background

-Objectives/Targets

3) Legal and Institutional Study, covering

-Analysis of Law and Regulations

-Institutional Analysis

-Conclusion

4) Technical Study, covering

-Technical Analysis

-Site Enablement

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-Basic Engineering Design

-Scope of PPP Project

-Output Specifications

-Conclusion

5) Project Feasibility Study, covering

-Analysis of Social Benefit Costs

-Market Analysis

-Financial Analysis

-Risk Analysis

-Tariff Structure Analysis

-Conclusions

6) Environmental and Social Study, covering

-Environmental Analysis

-Social Analysis

-Plan of Land Acquisition and Resettlement

-Conclusions

7) Cooperation Form (Choice of Modality Review in Infrastructure Provision

8) Appraisal of the Needs for Government Support and / or Government Guarantee, covering

-Appraisal on Government Support

-Appraisal on Government Guarantee

-Conclusions

9) Conclusions and Recommendations

10) Attachments

(2) Possibility of Unsolicited Measure

Unsolicited measure as direct appointment is not allowed under PR 67/2005, however, PR

67/2005 prescribes the cooperation project based on initiative of business entities which shall be

applicable under the following criteria:

1) Not included in the sector related master plan

2) Technically integrated with the sector related master plan

3) Financially and economically feasible

4) Does not need any Government Support in the form of Financial Fiscal Contribution

(Article 10 of PR 67/2005)

If the initiative of business entities is accepted by the government, the project shall be

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compensated by the following measures:

1) Added value;

2) Provision of right to make an offer by Business Entity or Foreign Legal Entity initiator to

the best tender participant (right to match), in accordance with the appraisal result in the

tender process; or

3) Purchase of the Cooperation Project initiative including the intellectual property rights

thereof by the Minister/Chairman of the Institution/Head of the Region or by the tender

winner

Based on the interview to BAPPENASS on July 26, the NARC project would not be the

cooperation project based on initiative of business entities since the NARC project is listed in

MPA master plan which is considered as one of the sector related master plan. Also the NARC

project requires the government financial fiscal contribution. Therefore, it is clear that the NARC

is not entitled to receive above mentioned compensation from the government as a cooperation

project based on initiative of business entities under PR 67/2005. Also, under the SEZ law, the

selection of business entity as a partner of PPP project shall be under the public procurement

regulation.

3.3 Legal Issues on Hybrid Scheme

3.3.1 Applicability of PR54/2010 and GR6/2006

In order to implement Hybrid scheme in the project, mainly two types of contracts need to be

made; one is EPC contract for the construction of Incubation and Support Center and another is

BOT contract for DBFO of Research Center (including design of Incubation and Support Center).

The legal base of the EPC contract is Presidential Regulation No.54 year 2010 on Government

Procurement of Goods/ Services (Hereinafter ―PR54/2010‖). It seems to be no legal obstacle for

this EPC procurement.

On the other hand, the legal basis of BOT contract would be Government Regulation No.6 year

2006 on State/Regional Assets Management (hereinafter ―GR6/2006‖). GR6/2006 allows the

utilization of state or regional government property for private as BOT scheme with the following

condition (Article 27).

- The facility which private develop shall provide the public services

- Not funds are provided from State and Regional government‘s budget.

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Since the BOT contract of Research Center would provide public services and would not require

public budget, it would clear the above-mentioned conditions. Also no other major legal obstacles

are found.

3.3.2 Legal Issues on Hybrid Procurement

(1) Budgeting for Construction of Incubation Center and Support Center

In case of PPP Scheme with government subsidy, BPPT can be the only one GCA because

PR67/2005 does not prescribe national university as GCA. However, for the hybrid Scheme, not

only BPPT but also IPB and ITB can be GCA. If the all parties above have a role of GCA, each

party needs to apply for the budgeting of construction of Incubation Center and Research Center.

If only BPPT would have the role of GCA, only BPPT would apply for the budget for the

construction of above-mentioned facilities. In this case, the assets funded by APBN (using

BPPT‘s budget) will become the State assets (barang milik negara) registered under BPPT‘s name

as the asset user (pengguna barang).

(2) Budgeting for Non-academic Facility for Universities

IPB and ITB (with its status as PTBH) are allowed to propose for funding from APBN for the

implementation of higher education (Art 51(1) of GR 65/2013 and Art 91(1) of GR 66/2013).

However, there is no express provision for funding for non-academic purposes (although

generally IPB and ITB are allowed to conduct investment with commercial motive). It is assumed

that IPB and ITB are allowed to propose for APBN support for its investment as long as the

program is approved in the APBN discussion. If the investment by IPB and ITB is using the

funding from APBN, then the procurement of the goods and services must follow PR 54/2010 (as

amended).

(3) Joint Procurement

Based on Presidential Regulation No.54 of 2010 concerning Government Procurement of

Goods/Services as severally amended and most recently by Presidential Regulation No.70 of

2012 ("PR 54/2010"), ministry, government agency (BPPT), regional government, government

institution (IPB and ITB) may conduct joint procurement through joint procurement contract

(kontrak pengadaan bersama) (Article 50 paragraph and Article 53).

In elucidation of Article 53 paragraph (2) PR 54/2010, the joint procurement contract is

conducted in order to implement goods/service procurement, which fund originated from several

ministries, government agencies (BPPT), regional government, government institution (IPB and

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ITB), with different source of funds.

Article 53 paragraph (4) PR 54/2010 states that the responsibilities for budget in joint

procurement contract, is to be regulated in a certain joint funding agreement between the parties.

(4) Possibility of B to B Contract between GCA and the Private

There is a question if BPPT and Universities can have Business to Business contract for the

Research Center since there is no subsidy injection.

On the assumption that the land constitutes "State assets" or "region‘s assets" (i.e. land owned by

the state or by regional government), then BPPT/IPB/ITB cannot establish business to business

contract for BOT of the research center as well as O&M.

As a government agency, BPPT must follow GR 6/2006 in relation to optimization of state assets

under its control. GR 6/2006 sets out the minimum provisions in BOT agreement between

government and the private (Article 29 paragraph (5)). GR 6/2006 also sets out the minimum

obligation for private partners to pay fixed contribution to state/region account in every year

during operation period, which the number of amount based on calculation by the team

established by the Minister of Finance (in case of State assets) and Governor/ Regent/ Mayor (in

case of region‘s assets).

The Universities (IPB and ITB), as PTBH, have preliminary assets from separated state assets.

The separated state assets become the Universities assets and registered under its name. The

separated state assets do not include the land which given by state. Such land is still under the

name of government (state assets), but the revenues from utilization of such land become those of

the Universities (elucidation of Article 65 paragraph (3)a, Law 12/2012). It is considered that the

rights for universities to make decision independently and for authority to manage fund

independently are only applied to all assets under Universities‘ name, not to state or region assets.

Therefore, the Universities can have B to B contract with third parties, to the extent the contract is

not related with the use of state assets or region assets. As long as the assets are classified as state

assets, then the use of state assets shall follow the provisions on utilization of state/region assets

(GR 6/2006).

3.4 Alternative Legal Basis

3.4.1 Joint Venture between Government and Private Entities

The national government could potentially enter into a joint venture with private entities in order

to develop the Project. The capital participation of the national government in the joint venture

can be made by making cash injection or in kind contribution (land or otherwise). In return to such

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participation, the national government (through the Ministry of State Owned Enterprises) will

own certain shares in the project company.

In order to make the participation, the national government will need to obtain approval from the

parliament (Dewan Perwakilan Rakyat or "DPR") and a promulgation of a government regulation

(peraturan pemerintah).

JICA Study Team believes that the hurdle to obtain approval from the parliament is high.

3.4.2 Special Economic Zone (SEZ) Framework

(1) Applicability of SEZ Law

SEZ is regulated under Law No.39 of 2009 on Special Economic Zone (herein after "Law

39/2009") and Government Regulation (herein after ―PP‖; peraturan pemerintah) No.2 of 2011 on

Implementation of Special Economic Zone (herein after "PP 2/2011")35

in which was amended

by PP No.100 of 2012. SEZ is the defined area with certain border in the jurisdiction of Republic

of Indonesia which is designated to implement certain economic function and obtain certain

facility. Under PP 2/2011, a SEZ may, among others, be designated for the purposes of technology

development (including activities for research and technology, design and engineering, applied

technology, development of software and technology information related services) (Article 3 of

Law 39/2009).

Development, including land acquisition and physical construction, of SEZ may be financed by:

1) Business entity (private (PT), BUMN, BUMD, cooperative, or joint venture establish to

manage SEZ);

2) Cooperation of national government, regional government, and business entity (public

private partnership);

3) State budget and/or regional budget; and/or

4) Other legitimate sources in accordance with laws and regulations.

As noted above, a business entity (private entity) is allowed to propose for an establishment of

SEZ, and in which case such private entity may be immediately appointed as the SEZ developer

without the need for public tender. However, if the SEZ is proposed by private entity, then the land

acquisition and all financing of the SEZ will become the full responsibility of the appointed

business entity (SEZ developer).

A location to be designated as a SEZ must satisfy the following criteria:

35 The description of SEZ framework was cited or summarized from the Legal Review by HJ (See APPENDIX 3-1)

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1) Compliant with spatial plan and do not potentially harm to protection area (kawasan

lindung)

2) There is a support from the related provincial/regency/municipal government to determine

the project as SEZ

3) Location is close to international trading hub or near to international shipping lanes in

Indonesia, or located in an area with prime resources potentials

4) Having clear boundaries

The SEZ will be determined by President and stipulated by issuance of government regulation

(PP).

(2) Procedure for SEZ Application

Since SEZ application is necessary to be proposed by the executing organization with local

government agreement, the procedure shall be taken by each NARC project will be as listed

below.

1) Establishment of an Executing Organization

It is necessary to establish an executing organization for each NARC project site, which

shall involve the BPPT for the PUSPITEK site, IPB for the Leuwikopo site, and ITB for the

Deltamas site.

Based on the Article 5 of Law 39/2009, the executing organization may form as:

a) Business entity private enterprise (PT), state owned enterprise (BUMN: badan usaha

milik Negara), regional owned enterprise (BUMD: badan usaha milik daerah),

cooperative, or joint venture (JV) established to manage SEZ;

b) Regency/municipal government; or

c) Provincial government.

Therefore, BPPT, IPB and ITB shall establish the executing organization as a PT,

cooperative or JV.

2) Acquisition of Local Government Support as an SEZ Development Agreement

Document listed below are necessary to be attached to the SEZ application as an agreement

from the Local Government for the SEZ development.

a) Land use permit;

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b) Approval and recommendation letter; and

c) Incentive from the Local Government, if any.

3) Proposal/Application to the SEZ National Committee (SEZNC)

To fulfill the condition to be selected as for SEZ, it is necessary to have an initial meeting

between the executing organization and SEZNC. The contents of the initial meeting will be:

a) possibility and timing to be selected as SEZ, b) advice on preparation of the proposal, and

c) confirmation of necessary support from the central government authorities to accelerate

the selection procedure.

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Chapter 4. Incentive Policy

4.1 Overall Incentive Policy for Research and Industrialization

(1) Current Incentive Laws and Regulations for R&D

The incentive provided by the government of Indonesia for research and development activities

conducted by the business entities is mentioned in the Government Regulation (GR) No. 35 of

2007. The forms of incentives are; taxation, customs, and/ or technical assistance for research and

development. Also, Law No.36 of 2008 prescribes tax incentive for R&D.

The further regulation on the incentive, especially for the incentive in the form of technical

assistance for R&D is regulated in the Minister of Research and Technology of Republic

(RISTEK) Regulation No. 1 of 2012 on Technical Assistance for Research and Development to

Business Entities. RISTEK Regulation 1/2012 prescribes that the incentives provided by the

government for the business entities that conduct R&D activities in the form of technical

assistance by placing the experts and utilizing laboratory facilities in R&D institution.

Besides incentive to the business entities, the R&D institutions which provide technical assistance

for R&D can be granted financial support from government and regional government budget

( Article 17 & 18 of RISTEK Regulation 1/2012).

Table 4.1.1 List of Laws and Regulations regarding to Incentives for R&D in Indonesia

Laws/Regulations Numbers Covered Area Outline of Incentives

Law of Government of Indonesia No 18 of 2002

National System of Research, Development and Application of Science and Technology

Tax relief, risk mitigation, rewards and recognition, or other incentives that can encourage funding for R&D activities

Government Regulation (GR) No. 35 year 2007

Allocating Some Portion of Revenue of Business Entities to Improve the Capability of Engineering, Innovation and Technology Diffusion

Tax incentive, customs, and/ or technical assistance for R&D

Law of Government of Indonesia No. 36 of 2008

Income Tax Gross Income deduction for R&D activities costs

Government Regulation (GR) No. 93 of 2010

Donation for National Disaster, Donation for Research and Development, Donation for Education Facility, Donation for Sport Coaching, and Social Infrastructure Development Cost which are Deductible from Gross Income

Gross Income deduction for donation for R&D activities

Government Regulation No. 52 of 2011

Income Tax Incentive for Capital Investment in Certain Areas and/ or Certain Regions

To domestic entities taxpayers in certain business areas : reduction in net income by

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Laws/Regulations Numbers Covered Area Outline of Incentives

which is a second amendment of Government Regulation No. 1 of 2007 (the first amendment was Government Regulation No. 62 of 2008)

30% (thirty percent) of the Capital Investment, charged for 6 (six) years respectively by 5% (five percent) per years; Acceleration of depreciation and amortization imposition of Income Tax on dividends paid to foreign tax subject by 10% (ten percent), or a lower rate under the applicable Agreement of Double Taxation Avoidance losses compensation for longer than 5 (five) years but not more than 10 (ten) years .

Minister of Research and Technology of Republic of Indonesia Regulation No. 1 of 2012

Technical Assistance for Research and Development to Business Entities

placement of experts, and / or utilization of laboratory facilities in R & D institutions

Source: JICA Study Team

(2) SEZ

There are several facilities in the SEZ that can be enjoyed by investor or business entity which

conduct business activities. Every taxpayer which conducts business activities in the SEZ will get

facility of income tax and also can be added in accordance with zone characteristics (Article 30 of

Law 39/2009). Tax facility also may give to the investor in certain period in the form of reduction

of building tax (Article 31 of Law 39/2009). Import of goods to SEZ may get facilities in the form

of:

1) Suspension of import duties;

2) Exemption of tax, to the extent such goods are raw materials and production supporting

materials;

3) Exemption of value added tax or sales tax on luxury goods for taxable goods; and

4) No admission for import income tax.

In addition, every taxpayer which conducts business activities in SEZ may be given incentives in

the forms of exemption or reduction of regional tax and tax retribution in accordance with laws

and regulations in tax (Article 35 of Law 39/2009). However, it necessary to have discussion and

negotiation with the relevant government authorities, such as Ministry of Finance for the fiscal

incentives and Local Government for the simplify procedures, by each SEZ executing

organization separately.

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Since no platform for the figures on listed possible incentives above, the actual incentives in

surrounding countries below can be utilized as a reference for the negotiation.

Table 4.1.2 Fiscal Incentives Provided by Neighboring Asian Countries

Country

Basic

Corporate

Income

Tax Rate

Incentives on

Corporate Income

Tax

Incentives on

Import Duties/Customs

Tariff

Other Incentives

China 25% For investors:

Exemption for the first

2 years and tax at the

rate of 12.5% (50%

reduction) for the next

3 years for high

technology industries

in SEZ. For certain

projects in basic

infrastructure,

environment

protection and energy

there is ―3+3‖ years

tax holiday. Under

certain terms

enterprises investing

in integrated circuits

production can get a

―5+5‖ years tax

holiday.

As for high

technology industries,

a reduced rate of 15%

is eligible and an

additional 50%

deduction for R&D

expenses is applicable

regardless of location.

Exempted from

import duties on

imported capital

equipment in SEZ and

Economic and

Technological

Development Zone

(ETDZ) and High

Technological

Development Zone

(HTDZ).

Business tax is

exempted under some

conditions.

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Country

Basic

Corporate

Income

Tax Rate

Incentives on

Corporate Income

Tax

Incentives on

Import Duties/Customs

Tariff

Other Incentives

Korea 22% For investors:

Exemption for 5 years

and follow with 50%

reduction for 2 years

for specific sector

under the Restriction

of Special Taxation

Act. As for Free

Economic Zone

(FEZ), exemption for

5 years and then 50%

reduction for 2 years

are offered.

For developers of

FEZ: Exemption for 5

years and follow with

50% reduction for 2

years.

For investors and

developers: Exempted

for 3 years from

imported capital

goods.

For investors and

developers: Local tax

(acquisition/

registration/ property

tax) is exempted or

reduced based on

conditions. Cash grant

is provided under

several requirements.

India 40% For investors:

Exemption for first 5

years, 50% reduction

for next 5 years in

SEZ. Exemption for

Central Sales Tax.

Exemption from

Service Tax.

For developers:

Exemption on income

derived from the

business of

development of the

SEZ for 10 years.

Exemption for Central

Sales Tax. Exemption

from Service Tax.

Exemption from

dividend distribution

tax.

For investors and

developers: Duty free

import/domestic

procurement of goods

for development,

operation and

maintenance of SEZ

units.

For investors and

developers: Service

tax and commodity

tax are exempted

based on the

conditions in SEZ.

Also, VAT is

exempted in several

provinces.

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Country

Basic

Corporate

Income

Tax Rate

Incentives on

Corporate Income

Tax

Incentives on

Import Duties/Customs

Tariff

Other Incentives

Thailand 30% For investors: 100%

exempted for 3 years

in Bangkok

Metropolitan Area, 7

years in the suburban

provinces and 8 years

in other provinces.

For developers: 100%

exempted for 8 years

if the zone is

designated for

software development,

high tech industries or

agro-processing.

100% exempted for 3

years in Bangkok

Metropolitan Area, 7

years in the suburban

provinces and 8 years

in other provinces for

other types of zones.

For investors and

developers: Exempted

or reduced from

import duties on

imported machinery,

equipment, etc. that is

designated by BOI.

For investors and

developers: VAT for

imported capital

goods is virtually

exempted. Deduction

of transport cost and

utility cost from

taxable income under

some conditions.

Malaysia 27% For investors:

Exemption of 70% of

income for 5 years if

Pioneer Status is

applicable, Exemption

of 100% for 10 years

if Multimedia Super

Corridor Status,

Exemption of 100%

for 8-10 years in SEZ

in East Coast

Economic Region

(ECER-SEZ).

For developers:

Exemption of 100%

for 5-10 years if

developing

infrastructure of

industrial park and

SEZ or undertaking

the project in ECER.

For investors and

developers: Exempted

from import duties on

components,

machinery and

equipment that are not

produced locally in

ECER-SEZ.

If no income tax

holiday, alternatively

Investment Tax

Allowance (ITA) shall

be offered; (a) For

enterprises that hold

Pioneer Status, deduct

60% of capital

investment against

70% of income for 5

years, and (b) For

enterprises that hold

Multimedia Super

Corridor Status and

enterprises in

ECER-SEZ, deduct

100% of capital

investment against

100% of income for 5

years.

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Country

Basic

Corporate

Income

Tax Rate

Incentives on

Corporate Income

Tax

Incentives on

Import Duties/Customs

Tariff

Other Incentives

Vietnam 25% For investors: 100%

exempted for 2 years

in the promotion area,

4 years in the special

promotion area and

special promotion

sectors, followed by

50% reduction period

in 4-9 years.

For developers: The

same incentives will

be offered to

developers.

For investors and

developers: Exempted

from import duties on

machinery, capital

equipment and certain

types of equipment.

VAT is exempted for

investors under the

conditions.

Philip- pines

30% For investors:

Incentives by BOI:

100% exempted for 4

years for non-Pioneer

project and for 6 years

for Pioneer project). Incentives by PEZA: 100% exempted for 3-6 years depending on Pioneer / Non-pioneer project status. For Economic Zone Developers &Operators; Special 5% tax on gross income and exemption from all national and local taxes shall be offered.

Exempted from duties on import machinery, equipment, spare parts and accessories for investors (export-oriented enterprises).

Tax credit on raw materials, supplies and semi-manufactured Products, etc. Additional deduction from taxable income for labor expense, necessary and major infrastructure works, etc.

Source: JICA Study Team based on the data of JETRO and the websites of investment promotion agencies in the selected countries, www.worldwide-tax.com, and Ministry of Commerce &Industry of India, Department of Commerce

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Table 4.1.3 Summay on Non-Fiscal Incentives Provided by Neighboring Asian Countries

One-Stop Window /Simple

Procedures

Special Permit for Foreigners

Competitive Utility Tariff

Land Premium

Training for

Employees

Financial Assistance

(Grant/ Loan)

Others

Malaysia exists exists exists exists exists exists Flexibility in foreign exchange administration

Thailand exists exists none exists none none - Philippines exists exists none none none none Unrestricted

use of consigned equipment

Vietnam exists exists none exists exists exists (develop-

ment of

infra-

structure)

-

South Korea

exists exists none exists none exists Flexible approach to labor regulation. Establishment of educational institutions and hospitals for foreigners.

India exists exists none none none exists - Source: JICA StudySurvey Team based on the websites of investment promotion agencies in the selected countries.

4.2 Examples of Incentives in Other Countries

4.2.1 Singapore

(1) General Incentives

1) Pioneer status

Full corporate tax exemption up to 15 years for strategic high value-added manufacturing

or service projects

2) Development and expansion incentive (DEI)

5% corporate tax rate reduction. For up to 10 or 20 years. For local expansion, upgrade

equipment or business activities

3) Investment allowance (IA)

50% deduction of equipment investment. To encourage investment, technology

Allowance for purchase of equipment, to improve efficiency or to introduce new

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technology to the industry

4) Double Tax Deduction (DTD) for Internationalization

400% tax deduction on first $400,000 expenditure, 100% tax deductions on balance

qualifying expenditure. To support local businesses‘ activities overseas

(2) Tax Incentives for R&D

1) R&D Tax Allowance (RDA) Scheme

Supporting Research and Development Activities

Tax allowance of up to S$150,000 to be deducted from a company‘s assessable income

when profitable companies engage in qualifying R&D activities in Singapore

2) Liberalized Research & Development (R&D) Tax Deductions

Supporting Research and Development Activities

Tax deduction on 150% of qualifying expenditure incurred on qualifying R&D activities

performed in Singapore, both in-house and outsourced

3) Productivity and Innovation Credit (PIC)

Tax deduction / cash incentive for investment in innovation and productivity. (Activities

include R&D; Investment in design, automation, equipment, training; Acquisition or

registration of IP)

4) Research &Development and Intellectual Property Management Scheme

Tax exemption for 5 years on royalties and interest received from abroad

5) Section 14DA Enhanced Deduction for Overseas R&D

400% enhanced tax deduction on overseas R&D

6) Deduction of Patent Registration Fees

To encourage the patent registration in Singapore

(3) Grant for R&D

1) Research Incentive Scheme for Companies (RISC)

Reimbursable R&D grant for improved industrial competitiveness

2) Technology for Enterprise Capability Upgrading Initiative (T-UP)

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Covers up to 70% of costs of scientist or engineer from A*STAR attached to a technology

company to implement qualifying R&D projects. Relevant to medtech companies

3) R&D Incentive for Start-up Enterprises (RISE) Scheme

Cash grant of up to S$20,250 for at least S$150,000 worth of qualifying R&D expenses

during the first 3 years of start-up activities

(4) Tax Incentives for Supporting New Venture Formation

1) Angel Investors Tax Deduction Scheme

Supporting New Venture Formation

50% tax deduction for angel investors who invest at least S$100,000 in start-up

companies and hold investment for a minimum period of 2 years

2) Tax Exemption for Start-ups

Supporting New Venture Formation

Full tax exemption on the first S$100,000 and 50% exemption on the next S$200,000 of

chargeable income for any first 3 consecutive years of tax assessment for start-up

companies

(5) Grant/Fund for Supporting New Venture Formation

1) ACE Startups Grant

Up to S$50,000 matching grant to start first business

2) Business Angel Funds

Up to S$1.5 million matching investment by SPRING Singapore for angel funds

investing in seed or early stage start-up companies

3) Early-Stage Venture Funding Scheme (ESVF)

Up to S$10 million co-funding from the NRF (National Research Foundation) for

early-stage technology start-ups

4) Incubator Development Program (IDP)

Up to 70% grant support to incubators and venture accelerators to nurture start-ups and

hiring of mentors and to offset operating expenses

5) Startup Enterprise Development Scheme (SPRING SEEDS)

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Up to S$1 million matching investment by SPRING for private investment in start-up

companies

6) Initiatives in New Technology (INTECH)

Grants for capacity-building in technology-application, industrial R&D

7) Technology Enterprise Commercialization Scheme (TECS)

Proof of Concept or Proof of Value demonstration competitive grant

(6) Incentives for Supporting Human Resources

1) Precision Engineering (PE) Manpower Initiative

Training allowance for 5-year in-employment PE training programme. Relevant to

medtech companies

2) Singapore Translational Research (STaR) Investigator Award

To recruit world-class clinician scientists for translational and clinical research

3) Clinician Scientist Award (CSA)

Research funding and salary support to medical researchers

4) Translational & Clinical Research (TCR) Flagship Program

Up to S$25 million for 5-year collaboration in translating research into healthcare

solutions (bench-to-bed solutions)

5) Competitive Research Program (CRP)

Up to S$10 million for 3 to 5 years. Broad based program for potential strategic research

areas of the future

6) Health Services Research Competitive Research Grants (HSR-CRGs)

Up to S$ 1 million for 2 years for Principal Investigators (PIs) from local public

healthcare or academic institutions. For conducting and translating of HSR findings into

policy and practice

4.2.2 South Korea

(1) Incentives in Taxation

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The scope of corporate tax breaks has been expanded to more R&D projects for drug

development (Technologies for new growth engines, currently four biologics including stem cell

therapy products with vaccines recently added).

New financing to fund R&D related to exports (Export-Import Bank)36

, and financing for policy

loans related to drug development and equipment investment37

.

(2) Financial Support - Biofund to Nurture Bio Industry -

1) Seoul Biotech Fund

In 2009, Seoul City and the Ministry of Knowledge Economy created a 100 billion won

fund through a public-private joint investment. It invests more than 60 percent of the

entire fund in mid-sized companies with sales revenue of more than KRW 30 billion or

unlisted small or medium ventures in the biologics or medical equipment industries (GP:

Oxford BioScience Partners & Hanwha VC).The scope of corporate tax breaks has been

expanded to more R&D projects for drug development.

2) Korea Drug Development Fund (KDDF)

Total expenditure from September 2010 to September 2011 amounts to over 1 trillion

won (530 billion won from the government, 530 billion won from the private sector). The

fund is aimed at advancing investment strategies for drug development and R&D to

dominate the global market.

4.2.3 Taiwan

Taiwan is located at the heart of the Asia-Pacific region. In addition to superior geographic

location, well-established infrastructure, matured industry development and abundant

high-quality human resources, the government also offers incentives to make Taiwan more

investor-friendly, and try to help enterprises grow with high competitive advantages.

The incentives that Taiwan government is offering include "tax related incentives" and "non-tax

related incentives." Most of the tax related incentives are provided under the Statute for

Upgrading Industries (SUI), which was introduced in 1991. The SUI is meant to supplement other

tax regulations which also provide tax concessions.

The SUI has recently become expired on December 31, 2009. In its place, the government has

promulgated the Statute for Industrial Innovation (SII) to replace the SUI. Taiwan's corporate

income tax rate has recently been reduced. In the interest of creating a fair and competitive tax

36 Support for overseas phase-3 clinical trials up to KRW 0.1 trillion, 8-year maturity, prime rate 0.5 percent 37 Korea Finance Corporation, Export-Import Bank – up to 8-year maturities, prime rate of up to 0.5 percent

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environment, the areas where tax incentives are offered would need to be revisited. Consequently,

under the SII the only area of where tax incentive is still being offered is R&D credit.

For non-tax related incentives, considering developing companies' needs, our government has

provided "Industrial Technology Development Program," "Land Lease Incentives in Industrial

Parks," "Government Participation in Investment" and "Low-Interest Loans," etc. to reduce

businesses' operating costs.

(1) Tax Incentives for Biotechnology and New Pharmaceutical Industry

1) Background

Taiwan‘s economy has focused primarily on the development of manufacturing since the

1950s and the country has gained a global leading position in the semiconductor and

digital image industries. However, Taiwan has only a 0.5% share of total global

production value of the biopharmaceutical industry which is one of the new

knowledge-economy industries. To ensure a smooth transition to a knowledge-intensive

economic model, the Biotech and New Pharmaceutical Development Act was introduced

on July 6, 2007 to promote the development of knowledge-intensive industries such as

new drugs and high-risk medical devices, and to drive the transformation of Taiwan‘s

economy.

2) Incentive Items

The Biotech and New Pharmaceutical Development Act provides for a number of tax

incentives:

a) Incentives for R&D and Personnel Training

Biotech and new pharmaceutical companies are entitled to a deduction from their

profit-seeking-enterprise income tax liability when undertaking R&D on new drugs

and high-risk medical devices, as well as the training of personnel. The deduction is

limited to 35% of the total amount invested in R&D and personnel training and may

be credited against the profit-seeking-enterprise income tax within five years from

the year the tax liability is incurred.

b) Investment Tax Credit for Corporate Shareholders

Investors who invest in Biotechnology and new Pharmaceutical companies and hold

the shares for more than three years are entitled to a deduction from the

profit-seeking-enterprise income tax payable for a period of five years starting from

the year the tax liability is incurred, up to 20% of the acquisition cost of the shares.

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If the shareholder is a venture capital business, the corporate shareholders of the

venture capital business may claim a deduction when calculating their

profit-seeking-enterprise income tax liability for a five-year period starting from the

fourth year after the venture capital business becomes a registered shareholder of the

biotech and new pharmaceutical company. The deductible amount is calculated by

taking the shareholding ratio of the venture capital investment to the biotechnology

new drug company and the total paid-in capital, and applying the ratio to the

acquisition cost of the shares, up to 20% of the acquisition cost.

c) Tax Deferral for the Acquisition of Shares

To encourage technology investors and high-ranking professionals to hold shares in a

biotechnology and new drug company on a long-term basis and to participate in the

company‘s operations, such investors are permitted to pay tax based on the actual

trading price when the ownership of the shares is transferred, rather than paying tax at

the time the shares are acquired.

d) Rights to Issue Stock Warrants

To help biotechnology and new drug companies attract outstanding talent and acquire

technology, such companies may issue stock warrants to high-ranking professionals

and technology investors allowing them to subscribe to the shares at a price lower

than their face value. In such cases, the acquired shares are taxable only at the time of

actual transfer of ownership.

(2) Incentives for Science Park Investment/Location

1) Tax Incentives

-No taxes are levied on park enterprises with respect to imported machinery for self use,

raw materials, fuel, materiel and semi-finished goods. No paperwork required for no-tax

treatment, guarantees, bookkeeping or tax withholding.

-Park enterprises that export products or labor services are subject to zero enterprise tax.

-Corporate income tax: 17%

2) Protection of Investor Rights

-Foreign investors enjoy the same privileges and rights as domestic investors.

-Foreign investors can hold 100% equity in park enterprises, and can seek the

government of the Republic of China and local enterprises as joint investors.

-Profits, capital gains and interest from investments by foreigners or overseas Chinese are

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eligible for transfer overseas upon application.

-Where the equity stake of foreign investors, overseas Chinese investors or a combination

thereof shall exceed 45% in a particular enterprise, the government provides its

assurance that, within 20 years beginning on the day of operation, the government will

not purchase such equity stake.

-The foreign investor may apply for a one-time overseas transfer of the investment

amount upon the approval of the authority.

-Intellectual property rights and ownership rights are protected under law.

-Upon approval by the Park Administration, a science industry enterprise may engage in

import and export businesses related to its business.

3) Government Participation in Investment

-Investors can apply for government participation in investments, with the maximum

investment amount capped at 49% of principal.

-Agencies representing the government include Science and Technology Development

Fund and other development funds.

4) Capitalization of Technology Know-How‘s

-Upon certification by authentic organizations in form of technology capitalization

evaluation documents, together with approvals of shareholders‘ broad, a Park tenant

company may apply to the Division of Business Services of the Science Park

Administration to issue new stocks or to register modifications of new stocks regarding

innovative technology know-how‘s.

5) Capital Raising

-In case of capital raising demand, local or foreign investors may raise capital via

assistances of the Taiwan Venture Capital Association. The Association includes more

than 180 venture companies in Taiwan and holds regular seminars and meetings,

offering useful information for mutual interaction. Contact information of the

Association is as follows.

6) Incentives for Research and Development

-The Science Park Administration provides Park tenants innovative technology

industry-academia cooperation project grants, with a maximum grant of ten million

NTD. The grant, however, could not exceed 50% of project budget.

-R&D expenses can be deducted from corporate income tax up to 15% but the total

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deducted expenses cannot exceed 30% of the total corporate income tax.

-R&D equipments can be exempted from import duties.

4.2.4 India

(1) Incentives Related to Biotechnology

1) General Incentives for Investment in Biotechnology Industry

General incentives for investments in Indian biotechnology industry are as follows:

-100% foreign equity investment is possible in manufacturing of all drugs except

recombinant DNA products and cell targeted therapies.

-Department of Bio Technology (DBT) provides a ―single window processing

mechanism‖ for all mega biotech projects involving FDI (Foreign Direct Investment)

of US$22 million or more under the Foreign Investment Implementation Authority

(FIIA) with its Fast Track Committee (FTC) existing in DBT.

-Depreciation allowance on plant & machinery.

-Customs duty exemption on goods imported in certain cases.

-Customs & excise duty exemption to recognized Scientific & Industrial Research

Organizations (SIRO).

-150% weighted tax deduction on R&D expenditure.

-3 years excise duty waiver on patented products.

-100% rebate on own R&D expenditure.

-125% rebate if research is contracted in public funded R&D institutions.

-Joint R&D projects are provided with special fiscal benefits.

2) Industry Development Financing

For a potential entrepreneur, the Technology Development Board (TDB) in the

Department of Science and Technology (DST) and the New Millennium Indian

Technology Leadership Initiative (NMITLI) of the Council of Scientific and Industrial

Research (CSIR) have been the major sources of funds. Since its inception in 1992, the

TDB has promoted several new startup companies, by providing soft loans, especially for

the commercial up scaling of indigenously developed technologies.

The CSIR-led NMITLI has emerged as the biggest funding route for biotech sector. The

funding is typically for ventures with short project cycle, high-risk and low investment. It

funded the bioinformatics educational software development project of TCS, gene

marker identification project of the Institute of Genomics and Integrative Biology.

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3) Fiscal Incentives (Union Budget)

In order to further stimulate the market development of the biotech sector, the

Government has introduced a number of tariff and non-tariff measures:

-All drugs and materials imported or produced domestically for clinical trials are exempt

from customs and excise duties.

-Customs duty on import of reference standards has been reduced from 25% to 5%.

-To facilitate R&D in the biotechnology sector, the Government is planning to remove

the existing restriction of minimum export obligation of approximately US$4 million

to be able to avail exemption from customs duty on certain equipment.

-R&D units with manufacturing facilities can avail of full customs duty exemption for

certain equipment up to 25% of the previous year‘s export receipts.

4) Research and Development Funding Schemes of Department of Biotechnology

a) Objectives of Funding

Objectives of Research and Development Funding Schemes by Department of

Biotechnology are as follows:

-Realization of biotechnology as one of the greatest intellectual enterprises of

humankind, to provide the impetus that fulfills this potential of understanding life

processes and utilizing them to the advantage of humanity

-Launch of a major well directed effort with significant investment, for harnessing

biotechnological tools for generation of products, processes and technologies to

enhance the efficiency and productivity and cost effectiveness of agriculture,

nutritional security, molecular medicine, environmentally safe technologies for

pollution abatement, biodiversity conservation and bioindustrial development

-Scientific and technological empowerment of India‘s incomparable human resource

-Creation of a strong infrastructure both for research and commercialization,

ensuring a steady flow of bioproducts, bioprocesses and new biotechnologies

b) Targeted Research Areas

Targeted Research Areas of Research and Development Funding Schemes by

Department of Biotechnology are as follows:

-Animal Biotechnology

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-Aquaculture and Marine biotechnology

-Basic Research in Biotechnology

-Biofuels

-Bioinformatics

-Biological Control of Plants pests, diseases and weeds

-Bioprospecting and Molecular Taxonomy

-Biotech process engineering and industrial biotechnology

-Biotechnology of Medicinal and Aromatics plants

-Biotechnology of Silkworms and host-plants

-Crop Biotechnology

-Environment & Conservation Biotechnology

-Food Biotechnology

-Medical Biotechnology (Vaccines, Diagnostics, Drug Development, Human

Genetics & Genome Analysis, Seri Biotechnology, Stem Cell Biotechnology)

-Microbial Biotechnology

-Plant tissue Culture

-Human Resource Development

-Nano Biotechnology

-Women Biotechnology & Programme for Rural Areas and SC/ST population

-Jai Vigyan National S&T Missions

-Patent Facilitation

c) Components of Grants

Grants are for recurring and non-recurring requirements as well as for R&D staff

supports; recurring expenditure includes cost for chemicals, consumables, glassware,

domestic travel, contingency etc. Non-recurring expenditure includes support for

capital equipment, instruments, facilities and so on.

4.3 Examples of Necessary Incentives (Incentives for Start-ups and SME Strategy)

The ability to succeed in positioning NARC for success in commercialization depends upon

having the right mix of incentives to stimulate existing and emerging companies in conducting

product development as well as to attract critical venture funding for emerging companies.

In recent years, Battelle has conducted many surveys of U.S. life science executives on what

drives their investment in different locations. One such study released for the Council on

American Medical Innovation noted the concern that United States is falling behind in its R&D

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tax credit as well as other tax incentives and policies that incentivize medical innovation and

related manufacturing38

. A forthcoming study by Battelle for the Pharmaceutical Research and

Manufacturing Association suggests that along with IP protection policies, health care coverage

and payment and a well-functioning regulatory system, a key factor shaping investment decisions

is the tax system and incentives. A recent discussion that Battelle had with a leading industrial

biotechnology company executive familiar with Indonesia revealed that the most attractive or

important incentives that would positively influence their decision to locate an R&D or

manufacturing facility in a particular country or region were:

-General research tax credit

-Availability of a one-time credit associated with moving to a new facility or significantly

expanding an existing location.

One well-established incentive is to offset the cost of company research and development

activities.

As of 2011, 26 out of 34 OECD countries offer R&D tax incentives. Other emerging countries

such as Brazil, China, Russia, Singapore, and South Africa also offer R&D tax incentives. The

R&D tax incentives of the various nations differ significantly in terms of their size, design, and

whether they explicitly target certain types of firms or specific locations. Some credits are

provided based on the total volume of R&D conducted, whereas others, as in the U.S., are based

on increases in R&D spending above a particular base year.

Many countries offer larger credits for small and medium-sized companies. In some instances,

credits are provided for capital investments to support R&D. To make the credits more useful to

small, early-stage companies that may not yet be profitable, a number of countries – including

Australia, Canada, France, Ireland, and Singapore -- offer tax credits that are refundable,‖ i.e., the

firm, if it has no tax liability, may receive a cash grant for all or a portion of the credit39

. In the

U.S., 38 states reported offering R&D tax credits in 2010, a small number of which are refundable,

but the federal credit is not refundable40

.

Singapore provides a 400 percent deduction for R&D as well as for IP acquisition or protection,

training and approved design or automation project41

. As illustrated in Table 8, a number of

38 Gone Tomorrow: A Call to Promote Medical Innovation to Create Jobs and Find Cures in America, Prepared by Battelle for

Council on American Medical Innovation, June 2010. 39 Deloitte, ―Global Survey of R&D Tax Incentives‖, July 2011

http://www.deloitte.com/assets/Dcom-Canada/Local%20Assets/Documents/Tax/EN/2011/ca_en_tax_RD_Global_RD_Survey_TaxI

ncentives_111011.pdf. 40 Battelle, ‖BIO State Bioscience Initiatives,‖ 2010 41

See http://iras.gov.sg/irashome/PIcredit.aspx#About_Productivity_and_Innovation_Credit. Visited March 31,

2012.

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countries offer R&D tax incentives with the objective of inducing multinational companies to

locate or to expand R&D operations in their country.

Table 4.3.1 Examples of Key R&D Tax Credits of Different Nations, as of July 2011

Country R&D Credit Refundable

Australia 125% immediate super deduction for expenses incurred

175% enhanced super deduction is offered for expenditures

exceeding a 3-year rolling average.

Yes

Brazil 160% super deduction of the total R&D expenditures

The super deduction increases to 170% of the qualified

expenses if the entity increases the amount of researchers by up

to 5% in a given year

The super deduction increases to 180% of the qualified

expenses if the entity increases the amount of researchers by

more than 5% in a given year

Enhanced R&D tax super deduction for patents is an extra 20%

deduction when a patent is registered

Other excise and withholding tax exemptions available

No

Canada 20% federal tax credit for all qualifying R&D costs. Enhanced

refundable credits (35%) are available for Qualified Canadian

controlled private corporations. Tax credits are also available

from provincial authorities

Yes

Chile 35% credit against corporate income tax if applicable to

activities carried out in conjunction with pre-approved

universities and research institutes; remaining 65% may be

deducted from taxable income

150% super deduction of the qualifying R&D expenses

Business Tax Exemption for the transfer of qualified technology

Corporate tax rate for companies granted High and New

Technology Enterprise (HNTE) status is reduced from 25% to

15%

Newly established Technology and Software companies receive

a tax holiday (and new established HNTEs in certain provinces

may receive tax holidays)

Enterprise Income Tax exemptions for certain qualified

technology transfers.

No

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Country R&D Credit Refundable

France 30% tax credit for the first €100M of qualified R&D

expenditures incurred during the tax year; plus an additional 5%

of any amount in excess of the €100M threshold

Increased credits are available for new credit applicants - 50%

for the first year of application (subject to limitation), 40% for

the second year (subject to limitation), and 30% thereafter

Cash grants for R&D and acceleration of depreciation

deductions for fixed assets used in qualified research.

Yes

Ireland 25% incremental credit for all expenditures exceeding the ―base

amount‖

25% credit for expenditures incurred for buildings or structures

used in the conduct of qualified R&D activities

R&D grants are also offered

Yes

Israel Tax rate reductions though the Alternative Tax Program and

Strategic Program

Several grant programs are available.

NA

Italy 10% on expenditures for in-house research

40% for expenditures on research connected by contract with

European universities or other public research entities

Yes

Japan The credit equals 8% to 10% of qualifying expenditures for

large companies

The credit equals 12% of qualifying expenditures for SMEs

Both SMEs and Large Companies are eligible for an Additional

Incremental Credit

No

Russia Value added tax (VAT) —Full VAT exemption for new products

and technologies development or conceptual improvements of

existing products and technologies

150% super deduction for certain R&D expenses

No

Singapore 100% base deduction for qualifying R&D expenses incurred

Additional 50% deduction for certain R&D expenses incurred

in Singapore

Additional 250% or 300% enhanced deduction on the first

S$400K of certain R&D expenses

200% super deduction for certain expenses approved by

government

Yes

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Country R&D Credit Refundable

South

Africa

150% volume-based super deduction

Accelerated depreciation for R&D related capital expenditures

No

South

Korea

Tax credits for SMEs and large companies

Investment tax credits

3% deduction of revenue from taxable income

No

United

Kingdom

130% volume-based super deduction for large companies

175% volume-based super deduction for SMEs

Cash credits for loss position SMEs

Yes

United

States

Incremental tax credit of 20%

Accelerated Simplified Credit of 14%

No

Source: Deloitte Global Survey of R&D Tax Incentives, July 2011,

http://www.deloitte.com/assets/Dcom-Canada/Local%20Assets/Documents/Tax/EN/2011/ca_en

_tax_RD_Global_RD_Survey_TaxIncentives_111011.pdf

(1) Patent Box

A growing practice to encourage R&D and its commercialization is to allow corporate income

from the sale of patented products to be taxed at a lower rate than other income. This is sometimes

referred to as a patent box (so called because income derived from domestic patents is isolated

and taxed at a lower rate than the taxpayer‘s net income). A patent box is intended to encourage

commercialization domestically by lowering the effective corporate tax rate for knowledge-based

companies. Eight nations (Belgium, China, France, Ireland, Luxembourg, the Netherlands, Spain,

and Switzerland) offer this incentive (Table 7.5.5). The UK government recently completed a

―consultation‖ on the detailed regulations for a ten percent patent box (versus the corporate rate of

26 percent) due to come into effect in April 2013.

Table 4.3.2 Overview of Corporate Tax Rates and Impact of Patent Box Tax Policies on Tax Rates,

by Selected Country

Country Regular Corporate

Tax Rate

Patent Box

Rate

Qualifying Income

Belgium 20% 6.8% Patents and supplementary

protection certificates

China 16% 0–12.5% Registered patents and know-how

France 34% 15% Patents and supplementary

protection certificates, industrial

fabrication processes, and

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patentable inventions

Ireland 10% <10% Most IP

Luxembourg 17% 5.9% Software, copyrights, patents,

trademarks, design, or models, and

domain names

The

Netherlands

17% 5% Patents or IP from qualifying and

approved R&D

Spain 25% 15% Most IP

Switzerland 21% 0–12% Most IP

Source: Information Technology and Innovation Foundation,

http://www.itif.org/files/2011-pb-atkinson.pdf.

Just as important as having incentives for R&D to advance commercialization is the ability of

emerging bioresources firms to access venture and other sources of private capital. A great deal of

research suggests that venture capital plays an absolutely critical role in stimulating innovation.

Indeed, outside the United States, where venture capital is less well developed, governments see

the formation of a vibrant venture capital sector as one of the keys to stimulating innovation.‖ 42

Governments can seek to ensure that firms have access to the capital needed for sustainability and

growth by creating incentives to encourage private investment in companies or venture capital

funds and/or by directly investing in companies. A number of countries offer tax incentives to

help start-up companies and to encourage investment in start-ups. Examples include:

-Singapore offers an extremely broad array of tax incentives including ones targeted for

start-up companies. Under the R&D Incentive for Start-Up Enterprises, start-ups with few

shareholders engaged in at least S$115,000 ($91,441) in R&D annually can convert their

losses into tax grants up to S$15,000 ($11,926) for each of their first three years of

operations. Singapore also exempts the first S$77,000 ($61,225) of taxable income and

half the next S$200,000 ($159,056) from corporate income tax for qualifying start-ups and

offers an angel investor tax credit.

-The UK allows individual purchasers of shares in qualifying companies to deduct 20

percent of the value of their investment of up to £500,000 ($794,887) in relief against

income-tax liability. Gains on subsequent sale of shares are free of capital-gains tax. If

shares are disposed at a loss, the loss is deductible. The government has proposed

increasing the deduction from 20 percent to 30 percent.

42

G. Pisano ―Science Business: The Promise, The Reality and the Future of Biotech.‖ Harvard Business School

Press, 2006:115.

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-Italy exempts gains from investment in start-ups less than seven years old from taxation,

provided ownership was held for at least three years, and the gains are reinvested within

two years on start-ups in the same sector.

-To attract R&D investment in Canada, the Scientific Research and Experimental

Development Tax Credit offers corporations a 35 percent credit on the first C$3 million

($3 million) in qualified expenditures and 20 percent on excess, and the credit is

refundable for smaller Canadian-controlled private corporations. Additional credits are

available at the provincial levels.

-Under France‘s Young Innovative Companies program, companies less than eight years

old with R&D at least 15 percent of revenue can be exempted from social insurance

contributions and profit tax for the first three years of profitability and then at a scale that

declines over 12 years. In addition, for such companies, the R&D credit is refundable, and

investors can be exempted from capital gains tax on shares or options held at least three

years.

Still, the use of public dollars to directly invest in companies is an important means of leveraging

larger amounts of private investment. The E.U.‘s European Investment Fund (EIF) is an example

of a fund that leverages public sector funding to raise private funds. EIF makes equity funding

available by purchasing interest in privately managed venture capital partnerships specializing in

a region of the E.U. Each investee partnership secures other limited partner investors, thus using

public investment to attract and leverage private capital. The EIF manages member-nation

interests in 28 venture funds of which 11 include a life science focus.

The UK‘s Capital for Enterprise is a state-affiliated investment fund that also invests public

money in privately managed venture capital partnerships. In 2009, the government announced the

creation of a new UK Innovation Investment Fund comprising two 10-year funds that will pool

public and private investment to create a fund targeted at more than $500 million.

In Australia, the AusIndustry development agency offers flow-through tax benefits (including

eligibility of foreign investors for complete exemption from capital gains taxes) to eligible

venture capital firms. Also, the Innovation Investment Fund has directly invested more than

$A500 million ($516.4 million) in federal funds (alongside private co-investors) in the creation of

at least 16 new venture capital funds that target early-stage investing across several sectors.

China‘s Innovation Fund for Small Technology-Based Firms offers more than $600 million in

start-up capital in the form of grants, subsidized loans, and equity investments up to 20 percent of

a company‘s capital base to companies engaged in technology commercialization and innovation.

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4.4 Present Situation of Bioresource Use and Intellectual Property in Indonesia

4.4.1 Present Situation of Bioresource Use in Indonesia

In Indonesia, as a country with tremendous biodiversity, there is substantial priority placed on

ensuring that the natural resources are appropriately managed and preserved. As put forth in the

Indonesia‘s Biodiversity and Action Plan (2003-2020), the government seeks balance between

the dual goals of biodiversity preservation and bioresource use for economic development.

These regulations are influential factors in assessing the viability of a commercial bioscience

based industry. Some regulations are based on laws and others are based on institutional practices.

For international companies in particular, these regulations are a critical factor in defining the

attractiveness of the business environment in bioresource fields.

Described below are bioresource regulations that can affect research and innovation in the

proposed biocluster initiatives

(1) Biodiversity Treaty

Indonesia is a signatory to the Convention on Biological Diversity (ratified by the government in

1996, Act 4-1996) as well as the Nagoya Protocol on Access to Genetic Resources and the Fair

and Equitable Sharing of Benefits Arising from the Utilization, the Nagoya Protocol (Ratified by

the government in May 2013, Act 11-2013). As a consequence, policies regarding the

management and transfer of biological resources reflect these guidelines. The goals and

obligations under the Nagoya Protocol are summarized in the Table below.

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Table 4.4.1 Key Provisions and Obligations under the Nagoya Protocol

The Nagoya Protocol sets out core obligations for its contracting Parties to take measures in

relation to access to genetic resources, benefit-sharing and compliance as follows:

1. Access Obligations

Domestic-level access measures are to create a clear and transparent set of rules and procedures

to issue permits, promote research contributing to biodiversity and sustainable use, and reflect

the importance of genetic resources for food and agriculture.

2. Benefit-sharing Obligations

Domestic-level benefit-sharing measures are to provide for the fair and equitable sharing of

benefits arising from the utilization of genetic resources with the contracting party providing

genetic resources. Utilization includes research and development on the genetic or biochemical

composition of genetic resources, as well as subsequent applications and commercialization.

3. Compliance Obligations

Specific obligations to support compliance with the domestic legislative or regulatory

requirements of the contracting party providing genetic resources, and contractual obligations

reflected in mutually agreed terms, including access to justice. This is considered a significant

innovation of the Nagoya Protocol. In addition, the protocol calls for taking measures to monitor

the utilization of genetic resources after they leave a country including by designating effective

checkpoints at any stage of the value-chain: research, development, innovation,

pre-commercialization or commercialization.

Source: Convention on Biodiversity

Regarding follow up to the Nagoya Protocol, the technical regulations are currently being

developed by an interagency group led by The Ministry of the Environment and LIPI. These

conditions may have a significant impact on research and innovation regarding bioresources so

should be followed closely.

(2) Transfer of Biological Materials

1) Export

The export of biological materials is subject to approvals of various government agencies

and commissions. Key aspects of gaining approval are:

- Approval of a plan for the use of the microbe abroad

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- Agreement regarding an Memorandum of Understanding and

- Acceptance of a Materials Transfer Agreement (MTA).

The MTA is developed by the host Indonesian research institution and is not defined by the

regulations. This is therefore more a matter of institutional policy than government

regulation. The purpose is to protect the interests of Indonesia regarding potential uses of

the materials.

Ultimately approval for the export of biological materials requires consent by the State

Secretary and by the Ministry of Foreign Affairs' International Cooperation Office.

2) Import

To import non-native biological materials permission is typically needed from the relevant

agency or regulatory body. For example, to import microbes for agricultural purposes, the

permission of the Ministry of Agriculture is required. If the product is a biopesticide, then

the approval is via the Commission on Biocontrol Agents under the ministry. A second step

is the Plant Quarantine office where samples are held and inspected to ensure the accuracy

and safety of the actual sample being transferred. Finally, the microbe must be registered

with the Ministry of Agriculture.

If the species are clearly identified and known the process is relatively straightforward.

Also, if the purpose is primarily for research to be conducted at a research institution such

as a university or a national laboratory, then the permission can be facilitated by the

research host institution and can be attained in a timely manner.

3) Conservation Area Permits for Sample Collecting

In order to collect samples from "conservation areas" such as national parks, conservation

area permits are required. These permits are issued by the Directorate General of Forest

Protection and Nature Conservation. In addition, if samples are to be moved across

province borders, then a transport certificate is also needed. Transport Certificates are also

issued by the Directorate General of Forest Protection and Nature Conservation.

In order to receive permission to take samples from Conservation Areas, the researcher

must list all of the microbes or other biological samples that are expected to be taken. If, for

example, 1,000 microbes are anticipated then the identities of all 1,000 microbes should be

listed in advance. This can present a challenge if not all such identities are known or if the

purpose of the research is to identify certain types of microbes.

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In order to accommodate the discovery of new microbes, such discoveries are permitted as

long as they are anticipated in the list. This process can likely best be managed by the host

Indonesian organization.

For areas outside of Conservation Areas, such use permits are not required.

4) Restrictions on Domestic Natural Resource Transport

The large diversity of islands and provinces is also accompanied by restrictions on the

inter-island or inter-provincial movement of resources. For example, in logging, in order to

stop illegal logging which is aggravated by the inter-island transport of logs, there is now a

regulation in place that requires logs to be processed on the islands on which they are

harvested.

This then leads to an incentive to find higher value added products as well as ways to use all

of the biomass. One example in which ITB is engaged is the addition of composite

materials to lumber to create higher value laminate products.

(3) Research Registration for Foreign Researchers

For foreign researchers planning to conduct research or biological sampling in Indonesia, there

are a number of procedures that must be followed.

1) Research Permit

If a researcher is planning to conduct any field research, a research permit is required from

the Ministry of Science and Technology. This would require a research plan that describes

the purpose of the research as well as any travel that is anticipated. If the researcher is

planning to visit other provinces, a letter of introduction is required from the Ministry of

Science and Technology.

At IPB, in order to assure the smooth conduct of the research permitting, IPB assists

researchers in attaining research permits through IPB.

2) Researcher ID Card

If a researcher is planning to travel outside the host institution, then permission is needed

from the Police Agency in the form of a Researcher ID Card as well as a traveling permit.

This researcher card gives the researcher to conduct research indifferent provinces of

Indonesia.

3) Provincial Approval

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Travel to different provinces for research purposes also requires approval of the provincial

government. Provincial government‘s management this approval process via a national

network that is managed by the national Policy Agency.

(4) Transgenic Material Policy (Genetically Modified Organisms)

Policies regarding the research and commercialization of transgenic plants have been evolving

over the past fourteen years. In general policies are supportive of research and the Ministry of

Agriculture has certified a number of transgenic plants as safe for use as a food. However, the

Ministry of Environment has been cautious about the potential environmental impacts, adhering

to a strict precautionary principle that has not yet allowed such plants into the market in

Indonesia.

In 1999, the Government of Indonesia‘s Ministry of Agriculture gave its approval to the use of

certain transgenic crops, BT corn and Monsanto‘s Roundup Ready products for cotton, corn, and

soybean as safe for food. However, the move was opposed by the Ministry of Environment

which argued that Indonesia should follow the ―precautionary principle‖ and that further

environmental studies should be required. This difference in position has marked the evolution

of transgenic plants in Indonesia since that time43

.

Current policies of the Indonesian government do not allow for the commercial use of genetically

modified organisms. However, the Government of Indonesia (GOI) and local universities are

researching a number of transgenic varieties including virus resistance for tomatoes and potatoes,

delayed ripening for papaya, sweet potato pest resistance, and drought tolerant rice. In addition,

some Indonesian researchers have begun to focus on transgenic research applied to animals for

genotyping or genetic markers of Indonesian local livestock, such as poultry, cattle and sheep.

Thus transgenic research is pursued by numerous institutions in Indonesia and certification of the

safety of such plants as foods has precedents of over a decade. The bigger question for

commercialization appears to be the government‘s stance regarding environmental impacts.

Some of the key regulations are noted below.

- In 2005, Government Regulation No. 21 concerning Biosafety of Transgenic Products was

released.

- In 2008, the National Agency of Drug and Food Control (BPOM) published the Guidelines

for Food Safety Assessment on Transgenic Products which were simplified in 2012.

- In 2010, Presidential Regulation No. 39 was issued, which established the Biosafety

Committee for Transgenic Products, a necessary mechanism to complete outstanding and

new biotechnology regulations.

43 Richel Dursin, The Asia Times, ―Indonesian ministries at odds over transgenic crops,‖ March 7, 2001.)

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- In 2011, transgenic feed enzymes have been approved as a feed additive.

- In March 2012, labeling regulations for packaged and/or retail food products containing

transgenic ingredients were released. According to this regulation, the packaged food that

contains at least 5 percent of transgenic product must be labeled and stated ―Food Containing

Genetically Modified Material‖ on the label.

In 2011, two transgenic soybean varieties have received approval for food safety in Indonesia, as

well as six transgenic corn varieties. Three transgenic sugarcane varieties were recommended

for environmental safety by the Ministry of Environment. However the Ministry of Agriculture

has not provided a variety-release approval.

It is reported that the Ministry of Environment is expected to publish the guideline for the

environmental risk analysis of transgenic product in the near future.

Other than environmental safety and food safety assessment, transgenic crops for feed

consumption also need to be formally assessed for their feed safety. However, at the present

there is no guideline for a viable feed safety assessment.

Table 4.4.2 Regulatory Jurisdiction of Ministries Regarding Transgenic Plants and Organisms

No. Ministry Office Area of Responsibility

1 Ministry of

Environment

Deputy for Biodiversity Conservation

Enhancement and Environmental

Destruction Control

Bio-safety

2. Ministry of

Agriculture

Feed safety

3. Ministry of

Agriculture

Center for Investment and License Seed imports permit

4. Ministry of

Agriculture

National Seed Agency Crop variety release

5. Ministry of

Agriculture

Indonesian Agency for Agriculture

Research and Development

Research Permit

6. Ministry of

Agriculture

Indonesian Agency for Agriculture

Quarantine

Plant and animal

imports

7. National Agency of

Drug and Food

Control (BPOM)

Food safety

8. Ministry of Marine

Affairs

Research Center for Marine and

Fisheries Product Processing and

Fisheries products and

fish feed

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Biotechnology

9. Ministry of Forestry Forestry plants

Source: USDA Foreign Agricultural Service, ―GAIN Report – Agricultural Biotechnology

Annual 2012‖

Although the commercialization of transgenic products has not advanced in Indonesia, the policy

discussion seems to continue to contemplate possible revision. A National Biosafety Commission

for Transgenic Products under the Ministry of Environment, but comprising many ministries,

continues to hold discussions regarding the revision of transgenic biology policies.

In addition, domestic business interest seems to be rising, and this may affect the speed of change.

The Indonesia Coalition for Agricultural Biotechnology (ICAB), modeled on the success of the

Biotechnology Coalition of the Philippines, a pro-biotech advocacy association, was formed in

Lombok, West Nusa Tenggara on July 4, 2012 during the 5th Indonesia Biotechnology

Conference for supporting the Indonesia agriculture biotechnology.

Research and testing continues but field testing seems to be on a slow track at this time. Recently,

the Government of Indonesia conducted confined field tests of several transgenic crops, to

include rice (resistant to biotic stress), sugarcane (tolerant to biotic stress and modification of high

glucose content), cassava (modification of amylase), potato (resistant to biotic stress), and tomato

(resistant to biotic stress). Additional Government of Indonesia sponsored research projects on

transgenic plants such as virus resistance for tomatoes and potatoes, delayed ripening for papaya,

sweet potato pest resistance, drought tolerant rice, and pest resistant soybeans, remain ongoing,

although at a relatively modest pace.

The Biosafety Commission for Transgenic Products seems to be continuing a cautious posture at

this time, asking for additional data and not yet recommending approval for commercial use.

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Table 4.4.3 Status of Various Transgenic Crop Tests in 2012

No. Transgenic Crops Bio-safety Committee

Recommendation

Government Approval Status

1 Herbicide Tolerant Corn

(NK 603)

Safe for food consumption

(2010)

Food Safety Certificate issued by the

National Agency of Drug and Food

Control - BPOM (2011)

Safe for feed use (2012)

Feed Safety Certificate issued by the

Ministry of Agriculture - MOA

(2012)

2 Insect Resistant Corn

(MON89034)

Safe for food consumption

(2010)

Food Safety Certificate,

BPOM (2011)

3 Herbicide Tolerant Corn

(GA21)

Safe for food consumption

(2011)

Food Safety Certificate,

BPOM (2011)

4 Insect Resistant Corn

(BT11)

Safe for food consumption

(2011)

Food Safety Certificate,

BPOM (2011)

5 Insect Resistant Corn

(MIR162)

Safe for food consumption

(2011)

Food Safety Certificate,

BPOM (2011)

6 Insect Resistant Corn

(MIR604)

Safe for food consumption

(2011)

Food Safety Certificate,

BPOM (2011)

7 Herbicide Tolerant

Soybean (GTS40-3-2)

Safe for food consumption

(2011)

Food Safety Certificate,

BPOM (2011)

8 Herbicide Tolerant

Soybean (MON89788)

Safe for food consumption

(2011)

Food Safety Certificate,

BPOM (2011)

9 Ronozime AX (CT) Safe for feed consumption Feed Safety Certificate, MOA (2010)

10 Sugarcane (NXI-1T) Safe for food consumption Food Safety Certificate,

BPOM (2012)

11 Corn (Event 3272) Safe for food consumption Food Safety Certificate,

BPOM (2012)

12 Ice Structuring Protein Safe for food consumption Food Safety Certificate,

BPOM (2012)

Source: USDA Foreign Agricultural Service, ―GAIN Report – Agricultural Biotechnology

Annual 2012‖

Precautionary Principle

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The GOI‘s overarching policy on agricultural biotechnology is to ―accept with a

precautionary approach‖ with respect to environmental safety, food safety, and/or feed

safety based on scientific approaches as well as taking into considerations of religion,

ethical, socio-cultural, and esthetical norms. Therefore, several regulations and guidelines

have been issued to protect the public from the possibility of negative consequences of

biotechnology utilization.

As of to date, seven transgenic corn varieties, two transgenic soybean varieties, and three

transgenic sugarcane varieties have received approval for food safety in Indonesia. In

addition, two transgenic corn varieties have received feed safety approval. Transgenic

sugarcane varieties that have been approved for environmental safety are anticipated to

receive variety-release approval from the Ministry of Agriculture in the near future.

Two more transgenic soybean varieties and one transgenic corn variety are in pipeline for

food safety approval. Thus with positive momentum on the research and testing front, some

anticipate that first transgenic plant to be officially commercialized in 2015: locally

produced drought tolerant sugarcane.

On the other hand, however, the new environmental requirements for event approval may

delay the importation or development local commercial of genetically engineered seeds. In

addition, other considerations, such as religion, ethical, socio-cultural, and esthetical norms

could affect the acceptance of agricultural biotechnology.

(5) Summary

The management of the nation‘s biodiversity is a high priority in Indonesia as reflected in the 17

year time frame of the National Biodiversity and Action Plan, 2003 -2020. The plan calls upon

the country to seek an effective balance between biodiversity preservation and sustainable

economic development. To manage this balance, an array of regulations is in place or in

development. Understanding and managing landscape will be an essential task for promoters of

biobased industries and bioclusters.

The existing regulations can be complex for international partners. Thus one important role of

the Indonesian innovation institutions is partner with foreign companies and institutes to ensure

effective and efficient compliance that at the same time productively advance research and

development.

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4.4.2 Present Situation of Intellectual Property in Indonesia

The Indonesia intellectual property regime follows international practice under the World Trade

Organization and the Trade Related Aspects of Intellectual Property Rights (TRIPPS).

Indonesia signed the Patent Cooperation Treaty in 1997. The fundamental law governing patents,

Law No. 14, was established in August 2001. Just prior to this, in 2000, the government enacted

Act 29 which addressed Plant Variety Protection.

In 2002, the government passed Act 19 establishing copyrights.

There are three types of patents that can be files in Indonesia: (1) a PCT application which follows

the international practices under the WTO and TRIPPS, (2) a non-PCT patent application and (3)

and simple patent application. Non-PCT patents and those following the PCT procedures are

valid for 20 years from the filing date. Simple patents are only valid for 10 years.

Simple patents only cover products or mechanical devices and although these must be new and

industrially applicable, they do not have to be ―inventive.‖ Processes, uses compositions and

products characterized solely by their process cannot be applied for under this category.

Non-PCT patent applications and PCT applications have similar evidence requirements.

Non-PCT patents are typically aimed at only the Indonesian market. Due to the international basis

and scope of PCT applications, and implication that patent applications will be files in other

countries, there is the additional requirement of an International Preliminary Examination Report.

Thus among residents of Indonesia there is some trend to filing only Non-PCT patents in

anticipation of domestic market use and due to the lower filing costs.

The Figure below shows the number of PCT and non-PCT applications submitted by residents of

Indonesia. Overall the numbers of patents submitted by residents of Indonesia have been small

over the past decade, reaching 541 non-PCT applications in 2010 and only 258 PCT applications

in 2011.

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Source: WIPO, ―Statistical Country Profiles – Indonesia‖

Figure 4.4.1 PCT and non-PCT Patent Application filings by Indonesian Residents (Ref. WIPO,

Statistical Country Profiles - Indonesia)

Source: WIPO, ―Statistical Country Profiles – Indonesia‖

Figure 4.4.2 PCT and non-PCT Patent Application filings by Foreigners and Indonesian

Residents

0

100

200

300

400

500

600

Non PCT Filings By

Residents

PCT Applications

Filed by Residents

0

1,000

2,000

3,000

4,000

5,000

6,000

2001

2002

2003

2004

2005

2006

2007

2008

2009

2010

2011

Foreigner PCT

Applications

Foreign Non PCT

Applications

PCT Applications

Filed by Residents

Non PCT Filings By

Residents

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Table 4.4.4 Patent Applications by Residents and Foreigners in Indonesia

Foreigner PCT Applications

Foreign Non PCT Applications

PCT Applications Filed by Residents

Non PCT Filings By Residents

2001 2,901 813 197 212

2002 1,976 633 157 234

2003 2,620 479 163 201

2004 2,989 452 177 227

2005 3,536 533 163 235

2006 3,805 519 242 288

2007 4,357 493 209 279

2008 4,278 469 214 375

2009 3,761 342 247 437

2010 4,140 390 253 516

2011 4,839 458 - 541

Source: WIPO, ―Statistical Country Profiles – Indonesia‖

Source: WIPO, ―Statistical Country Profiles – Indonesia‖

Figure 4.4.3 Application of Simple Patents by Residents and Foreigners in Indonesia

0

50

100

150

200

250

300

Simple Patents by

Residents

Simple Patents by

Foreigners

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Table 4.4.5 Application of Simple Patents by Residents and Foreigners in Indonesia

Simple Patents by

Residents

Simple Patents by

Foreigners

2001 197 24

2002 157 48

2003 163 29

2004 177 32

2005 163 32

2006 242 26

2007 209 34

2008 214 34

2009 247 38

2010 253 36

2011 236 56

Source: WIPO, ―Statistical Country Profiles – Indonesia‖

The composition of patent applications divided by the major patent application categories is

shown in the Figure below.

Source: WIPO, ―Statistical Country Profiles – Indonesia‖

Figure 4.4.4 Patent Applications by Fields of Technology

Other

consumer

goods

10% Civil

engineering

8%

Furniture,

games

6% Other

special

machines

6% Engines,

pumps,

turbines

6% Basic

materials

chemistry

6% Chemical

engineering

5%

Textile and

paper

machines

5%

Pharmaceut

icals

4%

Environmen

tal

technology

4%

Others

40%

Share

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Plant variety protection is included under patent variety protection (PVP). There are some special

provisions. The scope of plant variety protection regulations covers the issuance of rights to

plant breeders of plant varieties that are produced and have new, distinct, stable, uniform and may

be named. PVP rights is issued to the applicant for a period of 20 (twenty years) for perennial

crops or 25 (twenty-five) years for annual crops after being given a PVP rights certificate.

(1) The Process

The process for patent filing and review is shown in the schematic below. The process generally

follows common steps in international practice. The time to approval shown to be typically 36

months is somewhat long and will need attention as the number of patents increase in the future.

Source: Patent Lens, Diagram from Access International Patent web site

http://www.access-ip.com/prosedur_paten.html

Figure 4.4.5 Patent Approval Process in Indonesia

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(2) Evolving Patent Situation of Public Institutions

With the strengthening of the patent system in 2001, the leading research institutions including

IPB, BPPT, and ITB strengthened programs to support patent development and filing. All

institutions continue to maintain technology transfer or commercialization offices. However,

since 2008 government policy changes have altered patenting incentives. It is anticipated that by

2014 the patent incentives should be properly realigned.

In 2008 the government decided to change the legal status of these institutions from private

entities (or semi-public) to fully governmental entities. Prior to this time, between 2001 and 2008,

these institutions had the legal status of semi-public institutions. As a result of the 2008 change,

currently, all three institutions are governmental entities and therefore all intellectual property

rights created from the work of the institution belong 100 percent to the government. There is no

division of benefits from royalties back to the researcher or to the institution. As a result there is

little IP being filed through the institutions. However the institutions are allowed to hold onto

their old IP.

The government is said to be attempting to revise this situation. There are discussions underway

at the Ministry of Education to revert the legal status of these institutions so that they can again

own and manage their IP. This may happen in 2014.

Instead of simply giving up patents, professors are choosing to file patent applications directly,

even though this will entail out of pocket costs. For industrial partners, it is thus important to

work with professors in the areas of interest and to consider working with the professors to help

support patent applications and patent costs.

As noted above, prior to the 2008 change, in the 2001-2008 periods these institutions managed

their IP institutionally as universities do in Japan or the United States. To provide incentives to

their researchers to produce IP, the institutions returned a percent of royalties back to the

inventing researcher(s) and to their research units. The distribution of benefits was as

summarized below.

Table 4.4.6 Distribution of Patent Royalties at Institutions When IP is Owned by the Institution

Institution Percent of Royalty

to Inventor(s)

Percent of Royalty

to Department

Percent of Royalty

to Institution

IPB 40 40 20

ITB 40 30 30

BPPT n.a. n.a. n.a.

Source: JICA Study Team

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This is approximately the same magnitude as provided in the US and in Japan.

Table 4.4.7 Number of Patent Applications and Granted

Institution Patent Applications Patents Granted

IPB 261 56

ITB 78 Approx. 10

BPPT n.a. n.a.

Source: JICA Study Team

Since patenting and patent management is a relatively recent activity, licensing is not yet

significant. Also, this has not been possible for these institutions on IP generated after 2008.

However, this is expected to change. As in all advancing countries, companies in Indonesia will

attach growing value to investing in innovation for their business growth.

Despite the government policy shifts, each institution continues to maintain an office dedicated to

managing intellectual property and business partnerships and to supporting researchers who do

wish to file patents. In return for ownership by the government, the government through the

university provides support in filing the patent and in addition covers the cost of the patent

application and maintenance. If the government decides not to support the costs of filing a patent,

then the researcher is free to file independently from the government and university. IPB uses a

panel of approximately 10 researchers to advise on the decision of whether to support or not

support the payment of patent costs. Also, at IPB the technology transfer office provides an online

service to facilitate the entry of patent information and advises researchers on the ultimate

application.

Patent management thus has a short and interrupted history at Indonesia‘s research institutions.

Nonetheless, these institutions continue to seek industrial partnerships in a variety of ways to

bring their innovations to society.

(3) Cooperative Research and Development

One important point to consider in understanding the role of an institution in innovation is that IP

licensing is only one element of successful commercialization. Innovations can be protected

through trade secrets, exclusive use agreements, and other arrangements as well. Although the

number of licensed patents may be modest to date, there are numerous spin-out businesses. IPB,

for example, notes 179 innovations that have received national recognition among a total of 510

awards given over the history of the nation‘s Inovasi Indonesia program that are attractive

commercialization candidates. For international partners, a key step in this environment is

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therefore establishing relationships with key partners through such vehicles as cooperative

research and development.

Cooperative research and development partnerships provide one straightforward path for

universities to secure benefit from their innovations under the current IP policies of the

government. If a university established a project with a company in which the company will pay

for a researcher's services, then the funds can be used directly by the researcher. One example is

IPB's recently developed partnership with Kao.

IPB and Kao have a cooperative agreement to extract, identify and screen certain tropical plants

for active compounds that may be of medicinal value. Kao provides a cooperative research grant

to IPB and the work is conducted jointly with Kao researchers visiting ITB and ITB researchers

spending time in Kao labs. The intellectual property is jointly owned and if Kao commercializes

any of the compounds found then there is a royalty payment back to IPB. IPB maintains

Indonesian rights.

Another example is from ITB which is the case of a cosmetic cream made from virgin coconut oil.

Researchers at ITB teamed up with UK cosmetics company Dermazone. Dermazone produces

and markets natural product based cosmetics with one of their lead products being an olive oil

based hand and body lotion. Olive oil is believed to have replenishing abilities in reducing

dryness in skin. The company learned of research at ITB regarding the use of virgin coconut oil as

a skin moisturizer. They entered into a cooperative R&D arrangement, with ITB researchers

developing both the virgin olive oil production process as well as the skin lotion formulation

process. The product is now available on the market in the UK and ITB receives royalties on

product sales.

In the commercialization phase the UK company‘s location in a foreign market proved to be quite

advantageous. Approval in the UK to market the lotion was achieved in a few months and the

product was transitioned to a commercial product in a timely manner. However, in Indonesia the

regulations and testing around skin lotions are far stricter and the product is in on a wait list that

could take two years to pass. International market diversification from international partners

could thus help to accelerate product to market times due to different market and regulatory

structures.

(4) Summary

Over the past decade, intellectual property laws comparable to the international standard have

been in place in Indonesia. In response to this framework, research institutions put in place

infrastructure and incentives to support the creation of intellectual property such as patents by its

researchers. Although a change in institutional legal status in 2008 changed this environment by

shifting all patent ownership from these research institutions – IPB, ITB and BPPT – to the

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government, this is expected to change in the near future to allow IP ownership again by these

institutions.

Innovation partnerships with international organizations for cooperative research and

development continue to provide an effective means of advancing innovations and are expanding

at these institutions despite changes in IP management processes. International partners bring the

added and important advantage of access to other markets which may be easier to penetrate for the

initial sales of new products.

4.5 Direction of Incentives from the Viewpoint of Target Market

A closer examination of best practices found across the target markets identified for the NARC

involving the three broad areas of Health Products, Industrial Products and AgriFood Products

suggest the types of investments needed by the government to advance the quality and

attractiveness of the NARC facilities.

In order to clarify the appeal and advantage of working with each institution, it is recommended

that each of the three sites develop a Signature Investment Platform. This would allow each

institution to show the offering of facilities, equipment and expertise being made available to

their partners to promote bio-science commercialization. Such Signature Investments should

complement the key platform assets of each institution, some of which are noted in the Table

below.

Table 4.5.1 Key Platform Assets at the Three NARC Institutions

BPPT IPB ITB

Industrial

Bioproducts

Center for

Bioindustrial

Technology

Oil palm genetic

engineering

Industrial enzymology

Starches

Surfactant and

Bioenergy Research

Center

Palm oil processing

research

Breeding and

cultivation of

energy/bioresource

crops

SEAFAST fats and

oils pilot plant

Micro and

macro0algae research

Biorefining Research

and Innovation Center

Life Sciences Center

Chemical engineering

Microbial

biotechnology and

industrial enzymology

Micro and

macro-algae

Lignocellulosic

biofuels from crop

residues

Bioethanol

Catalyst development

Agriculture

and Food

Center for

Agricultural

Cultivation

Technology

Livestock and

Center for Tropical

Horticulture Studies

SEAFAST Center

Plant improvement,

including marker

Biofertilizers

Oil crop development

(specialty oils)

Plant adaptation to

environmental stress

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aquaculture feed

development

Biopesticide

development

Soil improvement and

inoculants

Food product

development

Nutrition and

nutrigenomics

assisted breeding

New crop

introductions and

agricultural

diversification

Research farm and

greenhouses

Germplasm

repository

Extension operations

Value-added food

product development

Packaging center

Food safety and

evaluation

Business incubator

Health

Products

Center for Technology

for Pharmacy and

Medical.

Biotechnology

fermentation scale-up

facilities.

Analytical chemistry

Animal research

facilities

Pharmaceutical raw

materials development

Biopharmaca

Research Center

Ethnobotany and

bioprospecting

Analytical chemistry

Extraction and

process

standardization

Herbal medicine

efficacy, animal

testing and toxicology

Primate center

Small-scale GMP fill

and finish

Medical plant garden

and herbarium

Life Sciences Center

and School of

Pharmacy

Analytical chemistry

and chemical

extraction

Medicinal chemistry

Natural products for

treatment of specific

conditions (e.g.

neuro-degenerative,

diabetes, etc.)

Vaccine development

Pharmaceutical raw

materials development

Animal testing

facilities

Source: JICA Study Team

Reflecting these assets the following three Signature Investment Platforms are recommended for

consideration to address health products, biofuels and biochemicals, and agriculture and food.

4.5.1 Health Products Platform

(1) Signature Investment: Development of pilot-plant and scale-up infrastructure at BPPT

for the production of biologic products in volumes required for conducting Phase I and

Phase II clinical trials.

While BPPT currently has some bioreactor capacity, the current infrastructure is old and there is a

need to upgrade facilities and capabilities at BPPT to achieve GLP and GMP

standards. Companies participating in group meetings noted that they would be interested in

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contracting with such a facility within BPPT for production of new products, while similarly the

facility would facilitate the scale-up and production of products originating within the three

research institutions.

In addition, it was noted that the lack of a Clinical Research Organization (CRO) infrastructure in

Indonesia is a considerable barrier to the development of a domestic biopharmaceutical and

natural products industry. As such, the development at BPPT would benefit from development of

a basic CRO operation comprising capabilities in study design, regulatory affairs and trials

management. This will require establishing collaborations with Indonesian hospitals and

medical systems to gain patient access. Interest was also expressed in the development of BSL III

facilities at BPPT.

(2) Examples of University-affiliated Research Parks that have Successfully Employed This

Strategy

- University of Wisconsin, Madison, a leading biomedical university research center with one

of the most successful university-affiliated research parks in North America. Today the

University of Wisconsin research park encompasses 37 buildings totaling 1.8 million gross

square feet, housing 125+ companies with nearly 4,000 employees. A cornerstone of its

success has been its ability to offer a high quality environment for existing and start-up

companies, leveraging the broader specialized shared use laboratory facilities located at the

university. This includes an FDA-approved Good Manufacturing Practices facility for

biomanufacturing, housed in the Waisman Center, with capabilities in the production of

bio-therapeutics and vaccines for human clinical trials as well as full support for

Investigational new drug applications. Waisman currently operates and maintains seven

cGMP compliant cleanroom areas to accommodate clinical production of mammalian and

microbial therapies and aseptic filling of final products. The facility was designed to support

and segregate different manufacturing processes. Among its biomanufacturing capabilities

are gene therapies, cell therapeutics, vaccines, and recombinant proteins. The Waisman

Center has supported the development and clinical production of a number of novel types of

biotherapeutics from process development through to aseptic fill and finish.

In addition, the Waisman Center at the University of Wisconsin works to connect its industry

partners with other university resources to advance medical products into clinical trials. This

includes the University of Wisconsin, Office of Clinical Trials, established in 1988, which

largely supports industry-sponsored clinical trials on a fee-for-service basis for a range of

activities from regulatory services to patient accrual to bioinformatics and laboratory services.

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- The University of Iowa is an emerging 500 acre research park that currently is home to ten

well-established companies and has an active incubator with over 20 new business venture

tenants, many of whom are commercializing university technologies. It also houses several

university-related activities, including the University of Iowa Pharmaceuticals (UIP), an

FDA-registered contract pharmaceutical manufacturing and analytical testing facility that

produces a wide range of pharmaceuticals, including sterile injectable solutions and

lyophilized powders; topical semisolids and oral liquids; and tablets and capsules. UIP

services include clinical supply manufacturing, small scale commercial manufacturing,

analytical method development and validation, routine quality control analysis, and stability

studies. UIP capabilities include handling controlled substances and potent and cytotoxic

compounds. UIP employs 5 full time staff and its facilities are found both at University of

Iowa Research Park as well as at the main campus.

- The University of Maryland Baltimore‘s Biopark is a 12 acre park located adjacent to the a top

tier academic medical center, which now has nearly 500,000 sq. ft. of built out space and

supports over 650 company and university-affiliated jobs. Among Biopark‘s tenants are four

that offer commercial contract research services providing both cGMP manufacturing,

validation, regulatory services and early phase clinical trial services.

(3) Key Facilities and Equipment to Create This Capability

For Good Manufacturing Practices biomanufacturing facilities the standard tenant improvements

include:

- Clean rooms with direct digital control of room pressures, air flow, temperature, and humidity

with separate Air Handling Units (AHUs) for manufacturing areas

- Equipment Monitoring System monitors critical parameters and alarms for all cGMP

equipment

- Keycard access control to facility: cleanroom manufacturing areas, cell bank storage, and raw

material quarantine/release rooms

- Multiple pass-through compartments for flexible production of cell therapeutics or complex

biologics

- Dedicated showers and gowning areas for entering Microbial and Mammalian/Cell Therapies

Suites

- Pure steam generator for steam-in-place (SIP) bioreactors

- Dedicated cGMP sterilization and decontamination autoclaves with steam supply from pure

steam generator

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- Separate and locked ―Quarantined‖ and ―Released‖ raw materials and manufactured product

storage areas

- Dedicated cell bank and viral bank gas phase liquid nitrogen storage freezers

- Separate ready supply and decontamination areas

Common biomanufacturing equipment includes:

- Bioreactors of various sizes with digital control monitors for pH, dissolved oxygen, gas and

media flow rates

- Reach-In CO2 incubator

- Roller bottle apparatus

- Single use glass stirred tanks (36 liter capacity) for suspension cell banking, protein

production, or virus expansion.

- CYTO3 Bioreactor with digital control monitor for pH, dissolved oxygen, gas and media flow

rates

- Preparative Liquid Chromatography (LC) systems for downstream purification

- Scalable single-use Tangential Flow Filtration (TFF) systems

- Centrifuges

- Parallel plate single-use cell culture vessels (multi-tray cell factories) for adherent cell lines

For traditional pharmaceutical production, the typical facilities would include analytical testing

equipment, sterility equipment and general manufacturing equipment, including:

- Analytical laboratory equipment, such as titrators, coulometers; high performance liquid

chromography systems, spectrometers and spectroscopy systems, hardness testers,

osmometers, radiometers, turbidimeters, viscometers, and associated software.

- Solid dosage form equipment including capsule filling machines, capsule polishers, punch

tablet presses, rotary tablet presses, blending and mixers, drying ovens, mills and granulators,

pan coaters, tablet/capsule counters and sorters

- General manufacturing equipment including steel mixing tanks, tube fillers and sealers,

powder fillers, stirrers

- Sterile products equipment including stills, pure steam generators, lyophilizers, washers,

autoclaves

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4.5.2 Biofuels and Bio-based Chemicals Platform

(1) Signature Investment: Development of pilot-plant and scale-up facilities, including

integrated bio refinery operations, to be operated by ITB at the Deltamas satellite campus.

As envisioned, facilities will be developed to support work in both biochemical and

thermochemical conversion technologies from lignocellulose, starch/sugar, and plant oil

feedstocks. The ITB operation should ideally be designed to facility upstream or downstream

extraction of valuable phytochemicals, and the downstream processing of residual biomass into

value-added fuels and industrial chemicals. Given institutional interests in algae-based biofuels,

the facility should also contain scale-up facilities to facilitate algae propagation and processing

research. The Deltamas site, with large-scale land availability, and infrastructure specifically

designed to support industrial development, should be highly conducive to attracting international

and domestic energy and chemicals/materials companies to work with ITB and its partner

institutions. In addition to the development of a piloting and scale-up facility at Deltamas, the

JICA Study Team noted that life sciences labs at ITB‘s main campus have a substantial need for

upgrading of equipment and facilities. Supporting the development of more modern lab

resources at ITB for biological sciences and associated chemical engineering will be important for

assuring an enhanced pipeline of innovation from the institution.

(2) Examples of University-affiliated Research Parks that have Successfully Employed This

Strategy

- The Iowa State University BioCentury Research Farm is a 1,000+ acre site offering a unique

integrated research and demonstration facility dedicated to biomass production and

processing. Its unique facilities combine biomass feedstock production, harvesting, storing,

transporting and biorefinery processing into a complete system to develop the next generation

of biofuels and biobased products. The BioCentury Research Farm engages industry directly

on-site through collaborative projects and fee for services to tap the BioCentury Research

Farm‘s unique shared use facilities, including an incubator program where emerging

companies rent space and pilot-plant scale equipment. Many of the leading industrial

biotechnology companies are engaged at the BioCentury Research Farm including DuPont

Cellulosic Ethanol, Centocor, Pioneer Hi-Bred and Vermeer.

- The National Renewable Energy Laboratory, a U.S. Department of Energy facility, offers a

world-class Integrated Biorefinery Research Facility for industry use in developing, testing,

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evaluating and demonstrating processes for the production of bio-based products and fuels.

The Integrated Biorefinery Research Facility offers a 27,000 square foot biochemical

conversion pilot plant for converting cellulosic biomass into fuels and chemicals, as well as

supporting pretreatment processes. The facility also includes a compositional analysis

laboratory. While not a traditional research park, this shared use facility is a signature lab for

the Colorado Renewable Energy Collaboratory that advances university-industry partnerships

and taps the university research park found at the University of Colorado, Boulder.

(3) Key Facilities and Equipment to Create This Capability

There are a range of facilities that offer high value in advancing biofuels and bio-based chemicals,

including:

- Field capabilities involving a range of farming equipment, including tractors, forklifts, loaders,

trailers, forage wagons, etc.

- Drying, grinding and pretreatment involving bale processors, belt dryers, chilsonator, drying

mills, horizontal grinder, hammermills, sieve shakers, impregnator reactor systems

- Biochemical processing equipment involving multi-size fermenters, mixing vessels,

distillation towers, evaporators, process tanks, membrane filtration systems, decanting

centrifuges and autoclaves

- Thermochemical processing equipment involving fast pyrolysis processors, gasification

reactors, and syngas cleaning system.

4.5.3 Agriculture and Food Platform

(1) Signature Investment

IPB, as the premier institution in Indonesia for work in agbiosciences already has significant

resources and facilities to encourage product development, university-industry collaborations and

the commercialization of new products and technologies. That said, Battelle noted that certain

infrastructure at IPB, critical to the successful development of this platform, is in need of

upgrading and augmentation. In particular, IPB needs to have a new center built for advanced

plant sciences and for crop improvement research and development. This means developing

a facility with the modern analytical lab resources (genomics, NMR spectroscopy, mass-spec,

chromatography and wet lab resources) to facilitate basic plant sciences and applied plant

transformation/improvement research. The developed facility will need to have modern

environmentally controlled growth chamber facilities and, ideally, be co-located with controlled

greenhouse operations and land for field-trials and scale-up of varieties for release. While the

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SEAFAST Center contains business incubation and some food pilot-plant facilities, investments

are likely also required to improve equipment and facilities for the development of value-added

food products at ITB.

(2) Examples of University-affiliated Research Parks that have Successfully Employed This

Strategy

- The University of Saskatchewan and Innovation Place is Canada‘s undisputed center of

agbioscience research. Innovation Place has 177 tenant/clients distributed over 23 buildings,

employing nearly 4,000. About 27% of the tenants are considered to be in the agricultural

sectors (typically crop development or veterinary medicine), and another 8% in

pharmaceuticals (including now in the new vaccine focus). Among its industry tenants are

significant operations of Bayer CropScience and Dow AgroSciences. Innovation Place is

home to a contract bioprocessing center offering wet milling for the nutraceutical, cosmetic

and agri-food industries, offering technical staff experienced in Good Manufacturing

Practices and quality assurance.

The University of Saskatchewan, meanwhile, offers several specialized research centers,

including its highly regarded Crop Development Centre focused on crop improvement, new

crop development and the creation of new uses for crops. It also has a Feeds Innovation

Institute addressing value-added activities and a Centre for Northern Agroforestry and

Afforestation working at the intersection of forestry and agriculture. Among its shared use

facilities are research fields, seed facility, a pilot bioprocessing plant for isolating and

extracting compounds from crops and a controlled environmental growth facility.

- The Bio-Research & Development Growth (BRDG)Park in St. Louis, Missouri is located next

to Monsanto‘s main headquarters and major research and development facility. BRDG is

expected to comprise three buildings totaling 450,000 square feet. Building One has 17

tenants and houses Nidus Partner, a venture accelerator. Another building is home to the

Danforth Plant Science Center (formed in partnership with Monsanto), with leading research

strengths in disease resistance, biomass, and biosafety, as well as offering strong capabilities

in genomics/proteomics/computational biology and having an active industry engagement

program.

(3) Key Facilities and Equipment to Create This Capability

- Field farms

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- Controlled environmental facility programmed to produce various environmental conditions,

such as qualities and intensities of light, ranges of temperature and humidity

- Wet bioprocessing involving centrifuges, dryers, evaporators, process tanks, sieve tray

distillation system, and wet milling equipment

- Analytical labs involving chromatography, microscopy, phenotyping using 3d imaging, and

mass spectroscopy, along with bioinformatics platform for analysis

4.5.4 Responses towards this Platform

Proposing this platform and explaining how it will be effective, the institutions have

basically shown their understanding of the value of this approach, although it was

expressed by each institution that each has an interest in all of research focus areas

drawn on the Signature Platforms. Therefore they would like to have internal

discussions to decide which Signature Platform to pursue at their own institutions. The

Signature Platform concept is not to exclude any research area from any institutions but

to highlight the key areas which each institutions have the strengths in order to clarify

the appeal and advantage of working with each institutions. In order to make this

platform effective, it is essential that each institute develop or upgrade their current

assets, therefore the Signature Platforms also present a means of focusing key research

investments.

4.6 Considerations of the Incentive Scheme in Indonesia

In order to attract industries to conduct R&D in Indonesia, it is important to have incentives such

as tax deduction. It is more important to know the current incentive setups for R&D activity of

neighboring countries than other area of the world since neighboring counties would be major

competitors for Indonesian R&D business.

JICA Study Team selected Singapore, Malaysia, and Taiwan for comparative analysis to know if

there is comparative advantage in terms of incentives for R&D activities in Indonesia (See the

table below). JICA Study Team found there is various types of incentives for R&D in neighboring

counties not only tax incentives but also grant/subsidy type of gov‘t support, fund for R&D and so

on. Especially it is critical that grant/subsidy type incentive for R&D activity is missing in

Indonesia while neighboring countries provide various types of grant/subsidy for R&D.

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Table 4.6.1 Comparison of Incentive Policies for R&D among Neighbor Counties

Singapore Malaysia Taiwan Indonesia

Tax Incentive e.g. 150% of R&D expenditure can be deducted

e.g. 100% of capital expenditure for R&D can be deducted within 10 years. In-house R&D can claim 200% super deductions for non-capital expenditures

e.g.35% of taxable income within 5 years

e.g.100% of R&D expenditure can be deducted

Grant/Subsidy e.g. Cash grant of up to S$20,250 for at least S$150,000 worth of qualifying R&D expenses during the first 3 years of start-up activities

e.g. Exploratory Research Grant Scheme for Explore new ideas & concepts catalyst for new discoveries & inventions -Prototype Research Grant Scheme for research for product development prior to commercial launch

e.g. Subsidies 50% of research budget for Small Business Innovation Research -Subsidies to the set-up of R&D centers by multinational corporations up to NT$5 million each year, and 50% of the research budget

e.g. Research of National Innovation System (more than Rp 500 million per year per proposal)

Patent , Fund, Human Resources

e.g Deduction of patent registration fees. -Training allowance for 5-year in-employment PE training program. Relevant to med-tech companies

e.g Techno Fund to develop products & technologies for pre-commercialization stage Max: $1.6Million Pilot scale production

e.g. A Science Park tenant company can apply to the Division of Business Services of the Science Park Administration to issue new stocks regarding innovative technology know-how‘s.

e.g. Technical assistance by placing the experts and utilizing laboratory facilities in R&D institution

Source: JICA Study Team

To bring the R&D activities of the world class technology and science industries in Indonesia

would give enormous impact for the development of Indonesian economy. However, the current

incentive system does not have enough comparative advantage among neighboring countries.

JICA Study Team recommends establishing the following incentive policies.

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(1) Proposal based on the Comparison of Incentive Policies among Neighboring Countries

1) Creation of Grant/Subsidy type incentives for R&D activity

The neighboring counties have various types of grant/subsidy incentive policy for R&D

activities. In order to compete with those neighboring counties, JICA Study Team

recommends the Government of Indonesia (GOI) to consider establishing more

grant/subsidy type incentives for domestic and international companies especially for

NARC user whoes R&D is approved by GOI as strategically impoartant for industrial

development of Indonesia. This role might be initiated by RISTEK.

2) Stronger Tax Incentives at least to the level of Singapore and Malaysia

The current tax incentive policy of Indonesia is still less competitive comparing Singapore

and Malaysia. JICA Study Team recommends GOI to increase the level of tax incentive at

least to the level of Singapore and Malaysia which allow deducting 150-200% of R&D

expenditure. It is also provide strong incentives to R&D industries if tax is exempted for the

initial several years of operation for NARC users. This role might be initiated by Ministry

of Finance.

(2) Proposals for Incentivizing by Using Comparative Advantage of Indonesia

1) Privilege for Utilization of Biodiversity Natural Resources in Indonesia

Current Indonesian policy for bio resource is biased for protection and giving impression of

closed for the utilization of bio resources, which make international firms hesitate for

initiating R&D activity utilizing biodiversity in Indonesia. Therefore, it is important to shift

the policy direction to utilize bio resources more actively. By permitting the domestic and

international firms using NARC facility to utilize bio resources not only for research

purpose but also for subsequence commercial purpose, it would provide tremendous

incentives for high technology and science oriented firm to utilize NARC facilities for their

R&D activities. This role might be initiated by RISTEK.

2) Incentive for Commercializing Research Output originated from NARC

Having co-research with Indonesian public research institutions (BPPT, IPB and ITB) and

private firm and sharing intellectual property right among those parties in NARC, the

incentives should be also provided even it moves from research stage to commercial stage

as long as the project still sustain the conditions for receiving incentives during R&D. In

other words, if the privilege such as tax reduction would be given even after the commercial

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stage by utilizing the result of NRAC‘s co-research output, the private firm who is currently

considering only the construction of production line in Indonesia may seek the opportunity

for R&D activity as well. This role might be initiated by MOF.