LOCATIONThe conference will be held at the Indiana University Robert H.

McKinney School of Law, Wynne Courtroom, 530 West New York Street,

Indianapolis, IN 46202.

PARKINGParking is available for a nominal fee at the Campus Gateway Garage,

located near the corner of Michigan and California Streets.

HOTEL RECOMMENDATIONS NEAR THE LAW SCHOOLCourtyard Capitol (Marriott)320 N. Senate Ave.

Indianapolis, IN 46202

Marriott reservation line at 800-321-2211

Direct number: (317) 684-7733

www.marriott.com

The Westin50 South Capitol Ave.

Indianapolis, IN 46204

Phone: (317) 262-8100

www.westin.com

DISABILITYIndividuals with disabilities who need special assistance, please call

(317) 278-4789. Special arrangements can be made to accommodate

most needs.

Legal Issues in the Health and Pharmaceutical IndustriesTuesday, October 8, 2013

6.0 hours of cle credit, including 1.0 hour of ethics credit (pending approval)

6.0

hour

s of c

le cr

edit,

inclu

ding 1

.0 ho

ur of

ethic

s cre

dit

AN

NU

AL

CO

NT

INU

ING

LE

GA

L E

DU

CA

TIO

N P

RO

GR

AM

Lega

l Iss

ues

in

the

Hea

lth

an

d P

har

mac

euti

cal

Ind

ust

ries

NON-

PROF

IT OR

G.

U.S.

POST

AGe

PAID

India

napo

lis, In

Perm

it #80

3

lawr

ence

W. In

low H

all53

0 W

est N

ew Yo

rk St

reet

Indian

apoli

s, IN

4620

2

Tuesday, October 8, 2013

Tues

day,

Oct

ober

8, 2

013

ANNUAL CONTINUING LEGAL EDUCATION PROGRAMANNUAL CONTINUING LEGAL EDUCATION PROGRAM

Legal Issues in the Health and Pharmaceutical Industries

REGISTRATIONThe registration fee of $275 includes materials, refreshment breaks and

lunch. Please register online: http://bit.ly/LAWCLE13

The program will carry 6.0 of Indiana CLE credit (including 1.0 hour of Ethics

credit)(pending approval). You must include your attorney number if you wish to receive CLE credit. If you seek CLE credit in another state, contact

that state’s continuing legal education commission.

Registrations must be received by Tuesday, October 1. Cancellations after Tuesday, October 1, 2013, will not be refunded.

Questions? Call 317-278-4789.

How to Protect Against Rights of Medicare Advantage Organizations to Recover Double Liability from Settling Defendants

KennetH H. ZucKeRPartner, Pepper Hamilton LLP

Zucker is a partner in the Philadelphia office of Pepper Hamilton llP. His practice spans both the commercial litigation and Health effects Practice Groups of the firm’s litigation and Dispute Resolution Department. His practice focuses on nationwide multidistrict and class litigation where mass-produced products are involved. He principally represents clients in the pharmaceuticals and construction products industries, handling product liability claims, state

attorneys general claims, government investigations, and contract and IP disputes.He represents GlaxoSmithKline llc in the Avandia Marketing, Sales Practices and Products liability Multidistrict litigation, in which the Third circuit rendered its milestone decision addressing the rights of Humana Medical Plan, Inc. and other Medicare Advantage Organizations in the context of tort settlements.

Drug Safety communication: the evolving environment

GeOffRey M. LevittSenior Vice President and Associate General Counsel for Regulatory, Environmental and Global Supply Law, Pfizer, Inc.

levitt is responsible for managing global legal support for regulatory, safety, manufacturing and environmental operations. Prior to joining Pfizer in October 2009, he served as Vice President and chief Regulatory counsel at Wyeth. He has published and lectured extensively on regulatory law, and is a past member of the editorial board of the Food and Drug Law

Journal and a current member of the editorial board of the FDA Advertising and Promotion Manual. levitt is a member and past chair of the Board of the Food and Drug law Institute and received the Institute’s 2009 Distinguished Service and leadership Award. He also serves as chair of the PhRMA law Section executive committee. His recent publications include the book Competitive Challenges in the Drug Approval Process: Generics, Hybrids and Follow-on Biologics (2005), the chapter “Drugs: INDs and Full NDAs” in Food and Drug Law and Regulation (2d ed. 2011) (with James czaban), and the chapter “The Drugs/Biologics Approval Process” in A Practical Guide to Food and Drug Law and Regulation (4th ed. 2012). He earned his J.D. from Harvard law School and his B.A. from columbia University.

the impact of the fcPA and Other criminal Law enforcement Priorities on the Pharmaceutical industry

LAnny A. BReueRPartner, Covington & Burling LLP

Breuer is Vice chair of covington & Burling llP, where he specializes in helping clients navigate corporate crises, anti-corruption matters, money laundering investigations, cybercrime incidents, congressional investigations, and other criminal and civil matters presenting complex regulatory, political, and public relations risks. He served from 2009-2013 as Assistant Attorney General for the criminal Division at the U.S. Department of Justice. As one

of the longest-serving criminal Division chiefs in history, he oversaw nearly 600 lawyers at the center of federal criminal prosecution, policy, and legislation in the U.S. While at the DOJ, he spearheaded the publication of the Resource Guide to the U.S. Foreign Corrupt Practices Act. For his work in the criminal Division, he ranked sixth on ethisphere’s list of the 100 Most Influential People in Business ethics internationally and was recently named by the National law Journal as one of the 100 Most Influential lawyers in the U.S. Prior to his service at the DOJ he co-chaired covington & Burling’s White collar Defense and Investigations Practice Group.

cyber espionage and corporate intellectual Property

tOnyA cOMBS, ‘06Assistant General Patent Counsel – IP Protection & Security, Eli Lilly & Company

combs joined eli lilly & company in 2001 after receiving a B.S. in chemical engineering from Rose-Hulman Institute of Technology. She began her career as an engineer in Research and Development. After receiving a J.D. summa cum laude from Indiana University McKinney School of law in 2006, she prosecuted patents globally and litigated

patent cases for lilly’s central nervous system products. She also advised on applicable pharmaceutical law and regulations, contractual and alliance issues, and dispute resolution as Assistant General counsel in eli lilly and company’s Oncology Business Unit. In April 2013 she accepted a role as the Assistant General Patent counsel – IP Protection & Security, where she focuses on addressing the IP challenges presented by potential data losses via hacking or other means.

Doing Deals in A changing World: M&A in the Pharmaceutical industry in 2013

RAyMOnD O. GietZPartner, Weil, Gotshal & Manges LLP

Gietz, a partner of Weil, Gotshal & Manges llP since 1989, is a member of Weil’s Mergers & Acquisitions group. He represents buyers, sellers, boards of directors, committees of independent directors and financial advisors in connection with complex mergers and acquisitions transactions, including public and private companies, lBOs, asset sales and joint ventures. He regularly advises boards of directors and committees of defense,

corporate governance and other matters. He also has been involved in numerous proxy fights and other contests for corporate control. His representation involves a range of industries, including health care, financial services, steel and defense. He is recognized in Chambers USA: America’s Leading Lawyers for Business, Legal 500 US, New York Super Lawyers and has been featured as a “Dealmaker” by The American Lawyer. He received his B.A. from columbia college and his J.D. from columbia University School of law, where he was a Harlan Fisk Stone Scholar.

2013 Discipline cases: A year in Review

G. MicHAeL Witte, ’82Executive Secretary, Indiana Disciplinary Commission

G. Michael Witte was the first Asian American to serve as judge in Indiana. His 25-year judicial career included service as Judge Pro Tem of the Wayne Superior court No. 1; Judge of the Dearborn Superior court No. 1; and Judge of the Dearborn county court. He received both his B.A. and J.D. degrees from IU, served as President of the Indiana University Robert H. McKinney School of law’s Alumni Board in 2009, and was honored

in 2008 by the IUAA as its Distinguished Asian Alumni. He is a graduate of the Indiana Judicial college, the Graduate Program for Indiana Judges, and a former member of the Indiana commission on courts. He served as chair of the ABA Judicial Division and chair of the ABA National conference of Specialized court Judges. Witte joined The National Judicial college faculty in 1994. In addition, he has served as faculty for programs presented by the American Bar Association, National Highway Traffic Safety Administration, the National center for State courts, the National criminal Justice Association, the Indiana Judicial center, and the Indiana continuing legal education Forum. Witte’s teaching experience is primarily in legal ethics, impaired driving, and traffic court administration.

Moderator

DiAnA R.H. WinteRSAssociate Professor of Law and Dean’s Fellow, IU McKinney School of Law

Winters joined the IU Robert H. McKinney School of law faculty in August of 2012. She was a Visiting Assistant Professor at Boston University School of law, where she was also the Health law Scholar. There she taught environmental law, environmental litigation, and advanced civil procedure. Winters received her

Ph.D. in the History of the American civilization from Harvard University, and her J.D., cum laude, from New York University School of law, where she was a recipient of a Dean’s Scholarship. After graduating from law school she practiced law at Hogan and Hartson (now Hogan lovells), clerked for a federal judge in the eastern District of Pennsylvania, and was an Assistant Solicitor General in the New York State Attorney General’s Office. Her current research involves the judicial review of health and safety regulation.

PROGRAM

8:15 – 8:45 am Registration

8:45 – 9:00 am Welcome and Introduction

9:00 – 10:00 am How to Protect Against Rights of Medicare Advantage Organizations to Recover Double Liability from Settling Defendants

Kenneth H. Zucker, Partner, Pepper Hamilton LLP

10:00 – 11:00 am Drug Safety Communication: The Evolving Environment

Geoffrey Levitt, Senior VP & Associate General Counsel for Regulatory, Environmental and Global Supply Law, Pfizer, Inc.

11:00 – 11:15 am Break

11:15 am – 12:15 pm The Impact of the FCPA and Other Criminal Law Enforcement Priorities on the Pharmaceutical Industry

Lanny A. Breuer, Partner, Covington & Burling LLP

12:15 – 1:15 pm Lunch (no speaker, boxed lunch provided)

1:15 – 2:15 pm Cyber Espionage and Corporate Intellectual Property

Tonya Combs, ’06, Assistant General Patent Counsel – IP Protection & Security, Eli Lilly & Company

2:15 – 2:30 pm Break

2:30 – 3:30 pm Doing Deals in A Changing World: M&A In the Pharmaceutical Industry in 2013

Raymond O. Gietz, Partner, Weil, Gotshal & Manges LLP

3:30 – 4:30 pm 2013 Discipline Cases: A Year in Review

G. Michael Witte, ’82, Executive Secretary, Indiana Disciplinary Commission

Thank you to the law school’s Hall Center for Law and Health and Center for Intellectual Property Law and Innovation for their support of this program.