“DEVELOPING, OPTIMIZING & MANUFACTURING STEROIDAL APIs”

Sterling

Sterling, founded in 1976, is a specialized company exclusively dedicated to developing and manufacturing steroidal APIs. Our capabilities range from large scale, highly automated manufacturing to smaller-scale specialist production requiring greater hands on attention. Our manufacturing facilities have state-of-the-art control systems and itsenvironment is highly contained. Sterling API facilities have an excellent compliance track record with a strong FDAand AIFA (Italian Health Authority) audit history.

In July 2013 Sterling Chemical Malta Ltd. started its operations.

Today Sterling, as part of its contingency plan, has 2 sites (Italy and Malta) and 3 manufacturing facilities. Moreover, with the aim of asserting its presence in the U.S. market, Sterling Usa Corp. was established in February 2014 .

Product Listas of October 2014

Oral Anti-InflammatoryBudesonideDeflazacort

TopicalFlumetasone PivalateFluticasone PropionateHalobetasol PropionateHalometasone MonohydrateMometasone Furoate Anhydrous

Under DevelopmentFor information contact us

AntineoplasticAbiraterone AcetateDutasterideExemestaneFinasterideFulvestrant Injectable

Nasal and InhalationBudesonideCiclesonideFluticasone FuroateFluticasone PropionateMometasone Furoate AnhydrousMometasone Furoate Monohydrate

DienogestDrospirenoneEtonogestrelLevonorgestrelNomegestrol AcetateNorgestimate

Contraception

Ring, Implant

VeterinaryDesoxycorticosterone Pivalate

Audit Historyas of October 2014

APPROVED

EUROPEAN HEALTHAUTHORITY

2001 AprilApproved

2004 DecemberApproved

2007 AprilApproved

2010 AprilApproved

2013 AprilApproved

US FDA

2002 OctoberApproved

2007 SeptemberApproved

2010 NovemberApproved

2014 MarchApproved

COMPLIANCE

Gmp Certificationas of October 2014

Abiraterone AcetateBudesonideCiclesonideDeflazacortDesoxycorticosterone PivalateDrospirenoneDutasterideEtonogestrelExemestaneFinasterideFlumetasone PivalateFluticasone FuroateFluticasone PropionateFulvestrantHalobetasol PropionateHalometasone MonohydrateMometasone Furoate AnhydrousMometasone Furoate MonohydrateNomegestrol AcetateNorgestimate

Cep Certificationas of October 2014

BudesonideDrospirenoneFinasterideFlumetasone PivalateFluticasone PropionateMometasone Furoate AnhydrousNomegestrol AcetateNorgestimate

CERTIFICATION IN PROGRESS

Fulvestrant

Production Plants

ITALY

The area in Italy occupies approximately 50,000 sqm, the covered area is roughly6,000 sqm and there are green areas covering to 20,000 sqm. The two production buildings are completely independent from each other because they are served by separate utilities. Each plant is also equipped with relatedwarehouses and finishing area.

MALTA

The Malta facility occupies approximately 3,500 sqm, the production area is roughly 1,600 sqm. The plant includes scale-up,pilot plant, finishing area, labs, warehouses, maintenance and offices.

The Sterling property includes two sites: one in ITALY, and one in MALTA.

The multipurpose plant in Perugia has a capacity of approximately 40,000 reaction liters. It is made of 250, 2000, 4000, and 10.000 liter reactors. The attached finishing area is approximately 200 sqm.

The 6 mono-product plant, based in Perugia, houses six single product lines, with a total capacity of approximately reaction 50,000 liters. The attached finishing area is approximately 400 sqm.

The multipurpose plant in Malta has a capacity of approximately 20,000 reaction liters. The attached finishing area is approximately 150 sqm.

Research & Development

R&D activities have always represented the driving force behind our success. The strategic importance of innovation inour sector has brought about an ever increasing investment in research and development.

Thanks to our line of action, Sterling is able to feature important resources such as:

All of this makes Sterling a forefront company in the identification, development and characterization of new molecules and the development of related production processes.

The R&D department that is composed of 2 labs and 1 scale-up plant furnished with technologically advanced equipment. An expert team of chemists is available on site to satisfy customer needs from innovative synthesis development in the lab to piloting the framework.

A specialized team is dedicated to patent evaluation, development and patent filing of innovative processes for steroids in Italy.

A consolidated cooperation with the most important Italian and foreign universities and research laboratoriesfrom around the world.

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Quality Control Labs Highly qualified professional team work ina fully equipped laboratory in order to verify and certify the quality of our products.They work in strict accordance with themost stringent worldwide quality standards,beginning with the raw materials all the way to the finished products.

Sterling has recently opened a newdepartment, the Analytical Research Laboratory, which working under specific Customer requirements, adopts, develops and validates new methods for an easiercontinuation of projects.

Quality Control activity aims to provide reliable solutions and to continuously improve the analytical methods used in our products.

We continue to invest in the necessaryinstruments and technologies in order tokeep us at the forefront of chemicalinnovation and analysis.

You are welcome to visit our laboratories;this is an important feature of thecollaborative culture of our organization.

QA / Regulatory Quality Assurance

The Quality Assurance departmentis the Guardian of Quality within theCompany. We have a team dedicated to identifying and implementing new ICH guidelines. Our team is prepared to obtain quality objectives whichhave been universally recognized byInspection Authorities and the most important Pharmaceutical Companies from around the globe.

This system is periodically verified through internal, national andinternational inspectors who havebeen able to recognize the high level obtained by the system and the actual achievement of quality objectives multiple times.

Sterling has been inspected three times by FDA (last inspection on November 2010) and five timesby European Health Authority(last inspection on April 2013)with excellent results.

Regulatory Affairs

Sterling has a sizeable and highly qualified regulatory team that handlesthe requirements and needs ofCustomers and Health Authorities.

Speed, accuracy and flexibility arethe key and, thanks to many years of experience dealing with the main Health Authorities, Customers specific issues and Pharmacopoeias, Sterling has acquired a vast experience that allows supporting our customers proactively during the whole process that goesfrom the sample evaluation to thecommercialization of a drug.

With a solid base of reliabledocumentation, we are always ready to discuss any particular situation together with you and find a customized solution that will make your job easier.

The team in the last 3 years filed more than 300 DMF all over the world.

EHSSterling has always been sensitive to environmental issues, striving to ensure the health and safety conditions of itsemployees and the communities in which it operates.

In May 2012 Sterling obtained Health and Safety OHSAS 18001 and ISO 14001 certifications. The strengths recognized by the certification are the following:

a) Management Commitment b) Waste product management c) Training of employees and delegates responsible for the HSE management system

Sterling is committed to maintaining high system efficiency HSE minimizing the impact of its activities on the environment.

STERLINGSteroid Specialists

Sterling USA Corp.Business Development Office

77 Water Street, 8th FloorFinancial District New York NY, 10005Tel. +1 646.7224287 | mbl +1 917.9131179

www.sterling.it

Via della Carboneria, 30 - Solomeo06073 . Corciano . Perugia . ItalyTel. +39 075.5294001 | Fax +39 075.5294000info@sterling.it |

Sterling S.p.A.Headquarters, Manufacturing Site and R&D Site

HF 51, Hal Far Industrial EstateBirzebbugia BBG3000 . MaltaTel. +356 20908700info@sterlingchemicalmalta.com

Sterling Chemical Malta Ltd.Administrative Offices, Manufacturing Site and R&D Site