FOR THE LIFE SCIENCES INDUSTRY MAIN CONFERENCE DAY 2 THURSDAY, MAY 11, 2023

8:45

Opening Remarks from the Co-Chairs

Mara Senn Executive Global Compliance Leader GE Healthcare

9:00  IN-HOUSE COUNSEL THINK TANK

Tune in to an in-house counsel think tank where senior legal executives will address:

• Assessing which anti-corruption issues create the most risk when building your compliance program

• Deciding which metrics are rights to measure the effectiveness of your compliance initiatives

• Perspectives on designing and operating an anti-corruption compliance culture

• Matching resources with the most applicable risk

• Assessing anti-corruption compliance controls in an era of remote work

Adam Yoffie Senior Corporate Counsel, Litigation and Government Investigations Bristol Myers Squibb

9:30

Engaging with Foreign Governments and Providers: Special Considerations for Gaining Access to Government Formularies and the Sale of Drugs and Medical Supplies, Devices and Vaccine Procurement

• HCPs as government officials and how to mitigate risk when they may be wearing two hats

• The importance of including key contractual provisions, including audit rights, subcontractor notification requirements, annual compliance certifications, and mechanisms for billing for pass through costs

• Use of third-party intermediaries and the special risks they present in helping gain access to foreign markets

• The impact of political contributions and/or lobbying outside the United States

Brian Kowalski Partner Latham & Watkins LLP

THE LIFE SCIENCES INDUSTRY

10:30  Networking Break

10:45  RUSSIA-HYPOTHETICALS AND AUDIENCE POLLING

Russia Sanctions and the Unique Challenges for Global Life Science Companies

The far-reaching economic sanctions and export controls imposed on Russia over its invasion of Ukraine creates unique challenges for global life science companies, including complying with specific licenses authorizing business, risks associated with restricted parties, complex export control requirements and the heightened corruption risks associated with maintaining supply chains and operations.

During this session, benefit from practical insights on how to navigate converging risks and leverage compliance resources for effective risk management. The discussion will focus on the most critical considerations for life sciences companies.

Kristine Mueller

Senior Manager, Global Compliance Operations Anthrex

Mike Stanek

Associate Vice President, Assistant General Counsel – Litigation Eli Lilly and Company

J. Patrick Rowan Partner McGuireWoods

11:30  CHIEF COMPLIANCE OFFICER FOCUS GROUP

Chief Compliance Officer Perspectives: "Big Picture" Insights on Key Priorities and The Most Pressing Compliance Pain Points

Take a deep dive into the topics and areas that keep senior-level compliance executives up at night. Explore what is on their legal radar and why it should be on yours. Discuss how to institute a culture of compliance from the top down and more practical takeaways for strengthening your compliance program.

Betania Glorio Global and North America Chief Compliance Officer EMD Serono

Fabiana Lacerca-Allen

Senior Vice President, Chief Compliance Officer Aimmune

Member, Board of Directors, Shield Therapeutics plc

Gwen Chapman Chief Compliance Officer Illumina, Inc.

Jennifer Zerm Chief Compliance Officer Fortive Corporation

Networking Luncheon

1:30  AFRICA-HYPOTHETICALS AND AUDIENCE POLLING

Africa: Market Growth Drivers, Entry Challenges, and What it Takes to Strengthen and Monitor Compliance

• Shaping sales teams: Ensure a high degree of flexibility to ensure responsiveness to the needs of local markets and associated compliance challenges

• Forging local partnerships in private and public sectors: The importance of including key contractual provisions and audit rights and mechanisms for billing for pass through costs

• Addressing supply chain challenges: Route-to-market as a strategic lever

Naana Frimpong Partner DLA Piper

2:30

Maintaining Effective and Compliant HCP Relations in Practice: How Life Sciences Companies are Dovetailing Operationally Efficient Processes with Required Checks and Balances

• Operationalizing compliant HCP engagement strategies: Creating top-down approved policies, SOPs, and work instructions for transparency for different country and different state reporting

» On-going risk monitoring

ƒ Integration with enterprise risk management (ERP) systems

ƒ How often to conduct risk assessments: How much is too much?

ƒ The intersection of legal and compliance: Understanding the risks of the federal Anti-Kickback Statute for HCP engagements and transparency

» The omni-channel public/private HCP experience: Virtual calls, mobile app meetings and their associated compliance risks as well as the value of engaging HCPs on the virtual stage

ƒ Defining the difference between public and private HCP engagement

ƒ Assessing what is “fair market value” for HCP services for in-person and virtual settings

ƒ How to connect internal and external meetings where HCPs are involved and how

ƒ Practical solutions for boosting the internal and external customer experience

ƒ Transparent reporting mechanisms

• Examples of key violations and investigations involving interactions with HCPs-and lessons learned

Michele Adelman General Counsel and Chief Compliance Officer PHC Holdings Corporation

Marc Hennes Head of Legal Investigations Novartis

Jennifer Bragg

Partner, Life Sciences and Health Care; Litigation

Skadden, Arps, Slate, Meagher & Flom LLP

Dan Spicehandler Vice President, ComplianceCommercial Divisions Stryker

3:15  Networking Break

3:30  HYPOTHETICAL SCENARIOS AND AUDIENCE POLLING

The Grey Areas of G&E, Donations, Sponsorship and Hospitality in High-Risk Markets: What Companies are Now Doing to Strengthen Policies

Don’t miss this practical, interactive session that will delve into the most vexing “on the ground” dilemmas. Through use of hypothetical scenarios, the expert speakers will impart best practices for effective compliance decision-making amid a host of grey areas.

Topics will include:

• When donations can cross the FCPA line

• Responding to scrutiny over improper influence of healthcare providers through travel, gifts, entertainment – particularly in sponsorship of educational meetings and conferences

• When it is appropriate to retain a foreign healthcare provider for advisory services and compensate for their time

• Best practices for mitigating FCPA risk while staying on top of local legal requirements

• What level of due diligence is now required before outreach to an HCP?

• How companies are operationalizing controls around HCP conflicts of interest

4:15  Conference Concludes

Stacey J. Hanna General Counsel, Ethics & Compliance Lonza

David H. Resnicoff Partner Riley Safer Holmes & Cancila LLP

Kathryn Jenne Senior Counsel, Global Healthcare Compliance Abbott

For The Life Sciences Industry

VENUE INFORMATION Bed

Martinique New York Broadway

Address: 49 W 32nd St, New York, NY 10001

Reservations: 1-212-736-3800

American Conference Institute is pleased to offer our delegates a limited number of hotel rooms at a negotiated rate. To take advantage of these rates, please contact the hotel directly and quote “FCPA & Anti-Corruption for the Life Sciences Industry”.

Please note that the guest room block cut-off date is April 24th, 2023. After that date OR when the room block fills, guestroom availability and rate can no longer be guaranteed.