1. *All views contained in this presentation reflect the personal views of the presenter only. They do not necessarily reflect the views or position of Mylan Inc. and may not be attributed to Mylan Inc. July 10, 2013 Carmen M. Shepard* Food and Drug Law Institute Understanding cGMPs: What attorneys need to know

2.  Legal consequences − Criminal prosecutions: company and individual exposure − Seizures − Consent decrees − Warning letters − Navigating consequences of OAI Status 2

3.  Ascertaining legal requirements and options − GMP requirements come from laws and regulations − Appeal or litigation options − Effect on other jurisdictions − Disclosure obligations − Privilege Issues 3

4. 4 CompanySettlement Country Violation(s)YearProduct(s)Laws allegedly violated TAP Pharmaceutical Products$875 million USA Medicare fraud/kickbacks2001Lupron False Claims Act/Prescription Drug Marketing Act Schering-Plough$500 million USA Poor manufacturing practices2002Claritin FDA Current Good Manufacturing Practices AstraZeneca$355 million UK Medicare fraud2003ZoladexPrescription Drug Marketing Act Pfizer$430 million USA Off-label promotion2004NeurontinFalse Claims Act/FDCA Schering-Plough$345 million USA Medicare fraud/kickbacks2004Claritin False Claims Act/Anti-Kickback Statute Serono$704 million Switzerland Off-label promotion/kickbacks/monopol y practices 2005SerostimFalse Claims Act Schering-Plough$435 million USA Off-label promotion /kickbacks/Medicare fraud 2006 Temodar/ Intron A/ K- Dur/Claritin RediTabs False Claims Act/FDCA Purdue Pharma$601 million USA Off-label promotion2007OxycontinFalse Claims Act Bristol-Myers Squibb$515 million USA Off-label promotion/kickbacks/Medicare fraud 2007Abilify/SerzoneFalse Claims Act/FDCA Merck$650 million USA Medicare fraud/kickbacks2008Zocor/Vioxx/Pepsid False Claims Act/Medicaid Rebate Statute Cephalon$425 million USA Off-label promotion2008Actiq/Gabitril/ProvigilFalse Claims Act/FDCA Pfizer$2.3 billion USA Off-label promotion/kickbacks2009Bextra/Geodon/Zyvox/LyricaFalse Claims Act/FDCA Eli Lilly$1.4 billion USA Off-label promotion2009ZyprexaFalse Claims Act/FDCA GlaxoSmithKline$750 million UK Poor manufacturing practices2010 Kytril/Bactroban/Paxil CR/Avandamet False Claims Act/FDCA Allergan$600 million USA Off-label promotion2010BotoxFalse Claims Act/FDCA AstraZeneca$520 million UK Off-label promotion/kickbacks2010SeroquelFalse Claims Act Novartis$423 million Switzerland Off-label promotion/kickbacks2010TrileptalFalse Claims Act/FDCA GlaxoSmithKline$3 billion UK Off-label promotion/failure to disclose safety data 2012Avandia/Wellbutrin/PaxilFalse Claims Act/FDCA Abbott Laboratories$1.5 billion USA Off-label promotion2012DepakoteFalse Claims Act/FDCA Amgen$762 million USA Off-label promotion/kickbacks2012AranespFalse Claims Act/FDCA Ranbaxy $500 million India Poor manufacturing practices/failure to timely file required reports/false statements 2013VariousFalse Claims Act/FDCA

5.  Navigating product availability issues − Effect on contracts, bids Company’s obligations to third parties Third party obligations to company − Reporting requirements for shortages 5

6.  Leadership needs − How did we get here? − What are the consequences? − What is our strategy for dealing with this? − How do we keep it from happening again? 6

7.  Steps to take when an inspection is imminent − Check performance metrics, backlogs, repeating issues, policies APRs completed Investigations and deviations Change controls, etc. − Status of previous inspection commitments − Awareness of current trends by regulatory entities − Inspection readiness audits − Use of third parties  Data Integrity Issues 7

8.  Corporate governance  Maintaining state of control  Culture of Quality  Education in trends, the “c” in cGMP  Evaluation of effectiveness  Product robustness  Early warning signs 8