FCPA and Anti-Corruption for the Life Sciences Industry

Day One – Tuesday, May 8, 2012

7:45 Registration and Continental Breakfast

8:30 Co-Chairs’ Opening Remarks

Hank Walther
Partner,
Jones Day LLP (Washington, DC)
Former Deputy Chief, Criminal Division, Fraud Section, USDOJ

Eric D. Brown
Assistant General Counsel – Global Trade Regulations
Eli Lilly and Company (Washington, DC)

8:45 The Sweep in Review: Where We Are, What We’ve Learned and What’s Next

Gary Giampetruzzi
Vice President & Assistant General Counsel
Pfizer Inc (New York, NY)

Eric A. Dubelier
Partner,
Reed Smith LLP (Washington, DC)

Hank Walther
Partner,
Jones Day LLP (Washington, DC)
Former Deputy Chief, Criminal Division, Fraud Section, USDOJ

This exclusive session will provide practical guidance on how companies should update their global compliance practices in light of recently released settlements. Topics of discussion will include:

• What companies are involved in the sweep –pending investigations/disclosures vs.settlements/resolutions to date
• Addressing implications of recent investigations for small, medium and large pharmaceutical, medical device and biotechnology manufacturers
• Tips for incorporating government expectations into your global anti-corruption compliance program across key areas including –
  • gifts, entertainment and hospitality
  • internal reporting systems
  • risk assessments and audits
  • M&As and collaborations
  • third parties, particularly agents, sales reps, consultants and other HCPs
  • training
• Remediation and the aftermath – how to restore confidence and enhance compliance and internal controls after a government investigation has concluded

10:00 Managing Corruption Risks Created by HCP Travel,Gifts, Entertainment and Hospitality: How to Minimize Corporate Exposure across Global Operations

Fabiana Lacerca-Allen
SVP & Chief Compliance Officer
Elan Pharmaceuticals (South San Francisco, CA)

Ela Bochenek
Associate General Counsel – International
C.R. Bard, Inc. (Murray Hill, NJ)

Glenn Engelmann
Senior Counsel
McDermott Will & Emery LLP (Washington, DC)

• Crafting permissible guidelines for the travel, use and compensation of HCPs, consultants and advisory boards – how to manage the expectations of local government officials and HCPs
• Gifts: when gifts, benefits or sweetheart deals masquerade as “cultural sensitivity
• Involuntary payments: when intentions are good, but controls are weak
• Addressing hospitality and entertainment of doctors, physicians and consultants – managing the “reasonable and customary” standard across multiple jurisdictions
• Tips for developing a global aggregate spend program that promotes multi-jurisdictional transparency
• Training – how to ensure staff are up-to-date on what the global corporate guidelines are for gift giving, travel and hospitality and are committed to adherence
  • identifying red and green fl ags that can be used as a practical point of reference/guide for those on the ground in various countries
  • identifying to employees what types of gifts, travel, etc. will raise red flags to the government
    
    

11:00 Morning Refreshment Break

11:15 Distributor Management Case Study: Lessons Learned from the Russia Novo Nordisk Case

Oksana Migitko
Senior Counsel,
Pepeliaev Group (Moscow, Russia)

Jeffrey C. Eglash
Senior Counsel, Litigation & Legal Policy
General Electric Company (Fairfield, CT)

During this exclusive panel, be engaged in a case study examination of Novo Nordisk’s recent experience in Russia. Particular attention will be paid to exploring foreign sales channel compliance within life sciences operations and conflicts that may arise from obligations under the FCPA. Topics of discussion will include:

• Where is the line between FCPA compliance and abuse of dominant position under Russia competition law?
• Acting on negative findings — how to establish cause to terminate or unwind a distributor agreement
• Guidance on how life sciences companies should conduct due diligence and act on findings when there are reasonable suspicions of corrupt acts but no actual convictions or other official findings of wrongdoing
• Deciding whether to turn evidence over to Russian (or other) authorities when corrupt behavior is detected
• How can foreign importers determine if their local distributors are actually corrupt or simply the victims of black PR
• How the FAS may reconcile anti-monopoly laws and anti-corruption practices in other industries

12:00 Spotlight Address: A Behind-the-Scenes Look into IRS’ Role in FCPA Enforcement

Clarissa M. Balmaseda
Assistant Special Agent in Charge
IRS Criminal Investigation (Oakland, CA)

12:30 Networking Luncheon for Speakers and Attendees

1:45 Compliance Programs 2.0: How to Update Your Global Anti-Corruption Compliance Program to Meet Rising Government Expectations

Clivetty Martinez
Regional Vice President Latin America
Health Care Compliance & Privacy
Johnson & Johnson International, Inc. (Miami Lakes, FL)

Barbara Levi Mager
Head Legal AMAC
GEM & Head Anti-Bribery and Corruption Practice Team
Novartis Pharma AG (Basel, Switzerland)

Eric D. Brown
Assistant General Counsel – Global Trade Regulations
Eli Lilly and Company (Washington, DC)

L. Stephan Vincze – Panel Moderator
Director, Forensic & Dispute Services
Deloitte LLP (Boston, MA)

• How to adapt and re-adjust your compliance program in response to local FCPA risks
  • detecting transaction and project-based risks and addressing them up front in your compliance program
  • incorporating procedures into global and local compliance policies to keep tabs on local HCPs, third parties, consultants, agents and subsidiary operations
• How to address overlap and conflicts within and across departments in order to ensure a global integrated approach– procurement, finance, legal, compliance
• Ensuring information sharing across and between departments
• How to ensure effective reporting, oversight and accountability by global and local employees and officers – checks and balances for “staying connected”

3:00 Reducing Risk Exposure in CME Activity: How to Structure Physician Sponsorships, Grants and Advisory Boards without Running Afoul of the FCPA

Ashok Marin
Senior Counsel, Global Trade Compliance
GE Healthcare (New York, NY)

Patricia Mellon
Chief Compliance Officer
Carestream Health, Inc. (Rochester, NY)

• How to structure physician sponsorships, speaker programs and advisory boards in a manner that won’t raise FCPA red flags
  • establishing permissible guidelines for the use and compensation of KOLs and thought leaders
  • addressing their use as part of a promotions strategy
  • ensuring an objective process is used to bestow physician benefits
• Organizing global medical conferences – how to select a venue, who can attend, permissible travel guidelines
• Creating an effective mechanism for monitoring how grants funds are spent

3:45 Afternoon Refreshment Break

4:00 Minimizing Downstream FCPA Exposure Created by Joint Ventures, Mergers, Acquisitions and Business Combinations within the Life Sciences Industry

Jeanine Jiganti
Chief Compliance Officer & Vice President
Takeda Pharmaceuticals North America, Inc. (Deerfield, IL)

Derek Devgun
Principal Legal Counsel, Mergers and Acquisitions
Medtronic, Inc. (Minneapolis, MN)

Yogesh Bahl – Panel Moderator
Partner, Forensic & Dispute Services
Deloitte LLP (New York, NY)

• Understanding the FCPA risk profile of the acquisition target and tailoring the diligence review appropriately
  • defining how much due diligence is expected and required for a US target vs. foreign target
  • factors relevant to the risk profile assessment
  • evaluating the effectiveness of the target company’s procedures for identifying and mitigating FCPA risks
• Discussing the unique FCPA risk of acquiring a “start-up” company
• What to do if due diligence efforts reveal actionable problems/issues
  • disclosures to the DOJ and SEC
  • joint investigation
  • role of outside counsel
  • forensic auditors
  • securing a disposition prior to closing and other transactional issues
• Post-closing integration – managing immediate post-closing risk and integrating FCPA compliance programs

4:45 EU Anti-Corruption, Regulatory and Enforcement Update

Elizabeth Robertson
Head, Corporate Crime Practice Group
K&L Gates (London, UK)

• Overview of current local enforcement initiatives
  • local anti-bribery regulatory updates – overview of key updates to anti-corruption statutes in UK, Germany, France, Norway and Switzerland
  • key trends in anti-corruption enforcement targeted life sciences companies within the EU
• UK Bribery Act – update on enforcement and whistleblower disclosures made as part of the “SFO Confidential” initiative
• Lessons learned from recent cases

5:15 Conference Adjourns to Day Two

Day Two – Wednesday, May 9, 2012

8:30 Co-Chairs’ Remarks

Hank Walther
Partner,
Jones Day LLP (Washington, DC)
Former Deputy Chief, Criminal Division, Fraud Section, USDOJ

Eric D. Brown
Assistant General Counsel – Global Trade Regulations
Eli Lilly and Company (Washington, DC)

8:45 Focus on India, Russia and China: An Examination of Local Anti-Corruption Enforcement Efforts, Corporate Targets and How to Ensure Compliant Operations

Percy Bilimoria
Senior Partner,
AZB & Partners (Mumbai, India)

K. Lesli Ligorner
Partner,
Paul Hastings LLP (Shanghai, China)

Oksana Migitko
Senior Counsel,
Pepeliaev Group (Moscow, Russia)

• Overview of current local enforcement initiatives and key trends targeted at the life sciences industry
• Examination of DOJ and SEC cooperation with international enforcement authorities – lessons learned from recent international investigations/settlements
• International anti-corruption regulatory updates – overview of key updates to local anti-bribery statutes in India, Russia and China

10:00 How to Apply the Right Level of Due Diligence to Detect Hidden Government Connections When Selecting Foreign Doctors, CROs and Consultants

Sheri Rudberg
Regional Compliance Counsel – EMEA
Baxter Healthcare S.A. (Zurich, Switzerland)

Bret A. Campbell
Partner
Cadwalader, Wickersham & Taft LLP (Washington, DC)

• Practical tips for assessing points for FCPA risk exposure posed by relationships within the life sciences manufacturing, distribution and supply chain
  • selecting doctors how this process should differ when conducting company-sponsored vs. investigator-sponsored trials
  • evaluating industry reputation and professional record – warning letters, standing with his/her/their registry
  • ensuring a bonafide need exists for the clinical research
  • utilizing risk rankings to evaluate distributors
• Knowing how much due diligence is enough. What to look for Deciding whether or not a CROs screening of its employees and third parties is sufficient – how to document the qualification process
• Discussing the pros and cons of utilizing an outside contractor to conduct compliance screenings
• Minimizing your exposure to FCPA risk by including key terms in your agreements with third parties, CROs and agents to address corrupt behavior
  • how to address funding and payments in the context of your clinical trials agreement
  • audit provisions

11:00 Morning Coffee Break

11:15 How to Implement Effective Internal Controls to Prevent Corrupt Behavior and Minimize the Risks of Third Party Bribes in Foreign Clinical Research

Clivetty Martinez
Regional Vice President Latin America
Health Care Compliance & Privacy
Johnson & Johnson International, Inc. (Miami Lakes, FL)

Joseph Alesia
Senior Counsel, Ethics and Compliance/Legal
Baxter International Inc. (Deerfield, IL)

• Best practices for monitoring actions undertaken by HCPs, CROs, third parties and other consultants when interacting with local government officials during the clinical research process
  • how to establish procedures for ensuring local procedures are followed without exposing the company to potential FCPA violations -
  • establishing internal controls to detect and prevent local anti-bribery issues, particularly within foreign clinical research, sales and distribution operations – investigator, health ministry approval, patient payments
• Distinguishing parameters for locally-accepted/expected “grease payments” vs. what is permissible under the FCPA – knowing where to draw the line regarding what does/does not qualify as a facilitation payment
• Striking the balance between too much vs. too little oversight when managing and overseeing operations led by local third parties
• UK Bribery Act - how companies are updating global compliance programs to address facilitation payments across international life sciences operations

12:00 Interactive Panel Session & Q&A – FCPA Internal Investigations: How to Avoid Common Pitfalls That Can Lead to Prosecution

Karen A. Popp
Global Co-Chair, White Collar Practice Group
Sidley Austin LLP (Washington, DC)

Joshua Holzer
Chief Compliance Counsel for Global Trade
Pfizer Inc. (New York, NY)

During this interactive session, be engaged in a comprehensive discussion of what to do and not do while conducting an internal FCPA investigation. Learn what the most common pitfalls are, what actions must be taken immediately upon discovering wrongdoing and how information discovered during an internal investigation can be used to minimize or even prevent later prosecution, while also maximizing credibility to the Government. Please come prepared with questions as ample time will be provided for Q&A as well.

12:45 Networking Luncheon

2:00 Managing FCPA and Foreign Regulatory Requirements: How to Resolve Conflicts of Law

Jennifer G. Newstead
Partner, Davis Polk & Wardwell LLP (New York, NY)

Valli Baldassano
Former Executive Vice President and Chief Compliance
Officer, Cephalon, Inc. (Frazer, PA)

• Dissecting key areas of common conflict between the FCPA and local regulatory requirements
  • data privacy and data transfer
  • antitrust laws
  • attorney-client privilege
• Practical guidance on how to balance FCPA compliance obligations with foreign local regulatory requirements

3:00 FCPA, Corporate Governance and Personal Liability: How to Deal with Audit Committees, Board of Directors and Corporate Officers when FCPA Issues Arise

Daniel Garen
Chief Compliance Officer
Wright Medical Technology, Inc. (Arlington, TN)

Paul R. Berger
Partner,
Debevoise & Plimpton (Washington, DC)

William N. Pedranti
Partner,
Gordon & Rees (Irvine, CA)

• Addressing responsibilities of the Audit Committee and Board of Directors in the FCPA context
• How to translate day-to-day Board oversight into the FCPA compliance program
• Communicating FCPA risks to the Board
  • setting up an effective reporting structure
  • when a suspected violation should be reported to the Board
• Determining whether or not a separate committee of the Board should oversee FCPA investigations
• Managing diverging Board, Audit Committee and corporate officer views on how to proceed during an FCPA investigation
• Knowing when to retain legal counsel for the Board vs. corporate officers and who should they report to
• Understanding the outside auditor’s role during a Government investigation
• Lessons learned from recent FCPA investigations where corporate officers and corporations have been held criminally liable

4:00 Afternoon Refreshment Break

4:15 Mock Scenario: How to Conduct an Effective FCPA Risk Assessment for Global Life Sciences Operations

Erik Eglite
Vice President, Chief Compliance Officer and Corporate
Counsel, Lundbeck Inc. (Deerfield, IL)

Sujata Dayal
Corporate Vice President & Chief Compliance Officer
Biomet International, Ltd. (Warsaw, IN)

During this session, be engaged in a real-life mock risk assessment of a global life sciences company. Hear how senior compliance officers and legal counsel approach risk assessment evaluations
of key global operations within life sciences companies. Topics to be discussion will include:

• Outlining the process for conducting an effective risk assessment – which departments should be included/excluded
• How often should you perform the assessment, and when can you quit?
• Who should conduct the assessment and who should they talk to?
• Types of documentation to review/create
• What can you reasonably do to mitigate risks once identified?
  • criteria for selection of international business representatives
  • procedures for vetting, monitoring and re-qualifying
  • training of company sales and marketing personnel
  • establishing review thresholds as the size and/or percentage of proposed commissions grows
• How can you evaluate the effectiveness of your response?

5:00 Conference Concludes

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