18th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry - DS

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18th Advanced Forum on

FCPA & ANTI-CORRUPTION FOR THE LIFE SCIENCES

DISTINGUISHED 2023 CO-CHAIRS

NEW, PRACTICAL SESSIONS

‰ Assessing the Effectiveness of Your Compliance Program: Real-World Takeaways Amid the Latest DOJ Enforcement Posture

‰ Ephemeral Messaging: DOJ’s Expectations and Navigating WeChat Communication Pitfalls

‰ Employee Compensation and Clawbacks: Best Practices Amid Increased DOJ Oversight

‰ Russia Sanctions and the FCPA: Managing the Impact on Your Supply Chain and Compliance Risk Management

More Internationally-Focused Discussions:

‰ Revisiting Your Evolving Risk Profile in China and the Region: The Top 5 Most Vexing Questions and Best Practices for Navigating Grey Areas

LEARN AND BENCHMARK WITH SENIOR IN-HOUSE EXECUTIVES FROM:

Abbott

Aimmune

Anthrex

Bio-Rad Laboratories, Inc.

Dr. Reddy's Laboratories

Eli Lilly and Company

EMD Serono

Fortive Corporation

Illumina

IQVIA

Johnson & Johnson

Lonza

Medtronic

Merck & Co

Novartis

PHC Holdings Corporation

Regeneron

Sanofi

Stryker

Thermo Fisher Scientific

Zimmer Biomet

ç Managing Unique, Heightened Challenges in Brazil: Industry-Specific Hurdles to Market Entry and Due Diligence Post-Election

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

INDUSTRY Earn CLE/CPE CREDITS May 10–11, 2023 | Martinique New York Broadway, New York Associate Sponsors Supporting Sponsor Exhibitors
A FIRESIDE CHAT WITH Derek Ettinger Assistant Chief, FCPA Unit, Fraud Section, Criminal Division U.S. Department of Justice Mara Senn Executive Global Compliance Leader GE Healthcare Adam Yoffie
Ai Translate by LSI E T HIXBASE 360 editable font version
Senior Corporate Counsel, Litigation and Government Investigations Bristol Myers Squibb

FOR THE LIFE SCIENCES INDUSTRY

GOVERNMENT

Derek Ettinger

Assistant Chief, FCPA Unit, Fraud Section, Criminal Division U.S. Department of Justice

DISTINGUISHED IN-HOUSE EXPERTS

Arunabha Bhoumik

Executive Director, Assistant General Counsel, Head, General Litigation and Government Investigations

Regeneron Pharmaceuticals, Inc.

Mara Senn Executive Global Compliance Leader GE Healthcare

Senior Corporate Counsel, Litigation and Government Investigations Bristol Myers Squibb

Ricardo Caiado Partner

Campos Mello Advogados in cooperation with DLA Piper (Brazil)

Joy Dowdle Partner

Paul Hastings

Tarek J. Helou Partner

Wilson Sonsini Goodrich & Rosati

Brockton B. Bosson

Partner

Cahill Gordon & Reindel

Irene Chiu

Senior Vice President, General Counsel MicroPort Orthopedics

Kevin Espinoza Chief Integrity Officer

Kaleo

Marc Hennes Head of Legal Investigations

Novartis

Marilyn Batonga Partner Baker & McKenzie LLP

Liana Cunha Compliance Director, Latin America Thermo Fisher Scientific

Naana Frimpong Partner

DLA Piper

Scott Hollander

Assistant General CounselCompliance, Investigations and Litigation

Dr. Reddy's Laboratories

Jennifer Bragg Partner

Skadden, Arps, Slate, Meagher & Flom LLP

Jill Dailey

Chief Compliance Officer Incyte Pharmaceuticals

Gary Giampetruzzi Partner

Paul Hastings

Jay Holtmeier Partner WilmerHale

Darshak S. Dholakia Partner Dechert LLP

Markus Green

Vice President and Assistant General Counsel, Government Relations

Pfizer

Speakers Agenda - Day 1 Agenda - Day 2 Venue Accreditation Become a Sponsor About Us Pricing REGISTER AmericanConference.com/FCPA-Life-Sciences | twitter: @ACI_Conferences linkedin: ACI: Anti-Corruption / FCPA – Legal, Regulatory and Compliance Professionals 2 Part of C5 Group’s ANTI-CORRUPTION GLOBAL SERIES FCPA & ANTI-CORRUPTION
Adam Yoffie SPEAKER 2023 CO-CHAIR 2023 CO-CHAIR

FOR THE LIFE SCIENCES INDUSTRY

Kathryn Jenne

Senior Counsel, Global Healthcare Compliance

Abbott

Susan Lipsitz

Vice President, Associate General Counsel, and Chief Compliance Officer

IQVIA

David Ralston

Senior Vice President Deputy General Counsel

Taysha Gene Therapies

Yuet Ming Tham

Global Co-Head, White Collar, Litigation & Investigations

Sidley Austin LLP

(Hong Kong/Singapore)

James M. Koukios

Partner

Morrison & Foerster LLP

Lilian Lustre

Head of Ethics and Business Integrity, LATAM

David H. Resnicoff Partner

Riley Safer Holmes & Cancila LLP

Maria Villanueva Sessions

Brian Kowalski Partner

Latham & Watkins LLP

Sanofi Thaddeus McBride Partner

Bass Berry & Sims PLC

Ryan Rohlfsen Partner

Ropes & Gray LLP

Vice President, Compliance Officer, and Head of HR

Ra Medical Systems

Janice Wang

Senior Anti-Corruption Counsel

Gilead Sciences

Daryl Kreml

Chief Compliance Officer

Sage Therapeutics

Mark Mendelsohn Partner

Paul, Weiss, Rifkind, Wharton & Garrison LLP

J. Patrick Rowan Partner

McGuireWoods

Ashley Watson

General Counsel, Medical Devices

Johnson & Johnson

Fabiana Lacerca-Allen

Senior Vice President, Chief Compliance Officer

Aimmune

Member, Board of Directors Shield Therapeutics plc

Ja Moon Vice-President, Healthcare Legal and Compliance

Alector

Jennifer Saperstein Partner

Covington & Burling LLP

Matt Werner

Senior Vice President, Chief Compliance & Privacy Officer Bio-Rad Laboratories, Inc.

Channing Landreth

Associate Vice President, Managing Counsel

LabCorp

Kristine Mueller

Director, Global Compliance Operations

Arthrex Rebecca Orttel

Terri Segura

Vice President, Global Compliance Investigations

Zimmer Biomet

Jennifer Zerm

Chief Compliance Officer Fortive Corporation

Angelique Lee

Vice President, Chief Compliance & Ethics Officer

Jazz Pharmaceuticals

Vice President, Ethics and Compliance Medtronic

Dan Spicehandler

Vice President, ComplianceCommercial Divisions

Stryker

Speakers Agenda - Day 1 Agenda - Day 2 Venue Accreditation Become a Sponsor About Us Pricing REGISTER AmericanConference.com/FCPA-Life-Sciences | twitter: @ACI_Conferences linkedin: ACI: Anti-Corruption / FCPA – Legal, Regulatory and Compliance Professionals 3 Part of C5 Group’s ANTI-CORRUPTION GLOBAL SERIES FCPA &
ANTI-CORRUPTION

ANTI-CORRUPTION FOR THE LIFE SCIENCES INDUSTRY

MAIN CONFERENCE DAY 1

WEDNESDAY, MAY 10, 2023

8:45

Opening Remarks from the Co-Chairs

Mara Senn

Executive Global Compliance Leader

GE Healthcare

9:00  FIRESIDE CHAT

Adam Yoffie

Senior Corporate Counsel, Litigation and Government Investigations

Bristol Myers Squibb

DOJ Enforcement Updates in the Life Sciences Context: Key Updates on Individual Accountability, Measuring Past Misconduct, Cooperation Credit and Self Disclosure

• Update on recent enforcement trends-and priorities for the remainder of 2023 (and beyond)

• How DOJ weighs past misconduct and self-disclosure in the wake of the revised Corporate Enforcement Policy

• How credit for voluntary self-disclosures is distinctly important for life sciences companies

• Key metrics DOJ will use to assess a company’s program and commitment to fostering a culture of compliance

Derek Ettinger

Assistant Chief, FCPA Unit, Fraud Section, Criminal Division

U.S. Department of Justice

Tarek J. Helou Partner

Wilson Sonsini Goodrich & Rosati

Speakers Agenda - Day 1 Agenda - Day 2 Venue Accreditation Become a Sponsor About Us Pricing REGISTER AmericanConference.com/FCPA-Life-Sciences | twitter: @ACI_Conferences linkedin: ACI: Anti-Corruption / FCPA – Legal, Regulatory and Compliance Professionals 4 Part of C5 Group’s ANTI-CORRUPTION GLOBAL SERIES FCPA &

FOR THE LIFE SCIENCES INDUSTRY

9:45

EPHEMERAL MESSAGING

Life Sciences and the Continuing Compliance Challenges of Ephemeral Messaging: DOJ’s Increasing Oversight and How to Resolve the Most Complex Dilemmas

How are life sciences companies reviewing ephemeral business communications policies and procedures, as well as emerging privacy, security, and employment law scrutiny?

Don’t miss this critically important session as we discuss:

• The new expectations for retaining business records and correspondence

• Data privacy issues that can affect compliance with DOJ data retention policies

• How the life sciences industry is updating messaging app policies, procedures, and monitoring

• When to restrict use of messaging apps to company-owned

• The three biggest ephemeral messaging dilemmas for life sciences:

» Mitigating WeChat messaging and document sharing and retention risks when operating in China

» Reviewing data privacy policies and regulations: Ensuring that all business communications can be reviewed in high-risk jurisdictions like China, Latin America, and India

» Implementing internal investigations practices for data localization, collection, and review

10:45  Extended Networking Break

Jay Holtmeier Partner WilmerHale

Rebecca Orttel

Ryan Rohlfsen Partner Ropes & Gray LLP

Matt Werner Senior Vice President, Chief Compliance & Privacy Officer Bio-Rad Laboratories, Inc.

Speakers Agenda - Day 1 Agenda - Day 2 Venue Accreditation Become a Sponsor About Us Pricing REGISTER AmericanConference.com/FCPA-Life-Sciences | twitter: @ACI_Conferences linkedin: ACI: Anti-Corruption / FCPA – Legal, Regulatory and Compliance Professionals 5 Part of C5 Group’s ANTI-CORRUPTION GLOBAL SERIES FCPA & ANTI-CORRUPTION

FOR THE LIFE SCIENCES INDUSTRY

11:15  CRO AND SPONSOR FOCUS GROUP

Clinical Trials: The Latest on Managing Unique, Evolving Bribery Risk Factors for Sponsors and CROs

• Ensuring partners in global clinical trials are developing processes to determine the legitimacy of and need for clinical trials

• What CROs are doing to prevent improper payments, and reduce bribery risks when interacting with government officials, and seeking clinical trial and marketing approvals

• Sponsor obligations to assess and monitor CRO anti-corruption compliance: How much due diligence and oversight can be done while remaining at arm’s length during the clinical trial?

• How to go about bridging the legal/technical divide when launching a trial

• Bridging the commercial/medical affairs divide

» Executing health economics and outcomes studies that can evaluate the impact of a drug’s use on variables such as medical costs and patient quality of life

• Knowing where the money is going: Effective monitoring and auditing plans for foreign clinical trials

» Mitigating bribery risks when engaging local doctors

• Explore different types of data and stage-gate approaches that can be used to assist with decisionmaking for allocating resources

• Establishing effective due diligence processes and oversight over all third parties involved in your clinical research plans

12:00  COMPLIANCE PROGRAM BENCHMARKING

Life Science-Specific Considerations for Measuring the Effectiveness of Compliance Programs: Real-World Takeaways for Pressure-Testing Your Program Amid the Latest DOJ Guidance and Enforcement Posture

Amid the newly revised DOD Corporate Enforcement Policy, it is critical that life sciences companies ensure that their compliance programs are fully developed, implemented and pressure-tested to confirm that they are functioning effectively and detecting issues when they arise.

• DOJ’s focus on the development of a compliance culture: Perspectives on designing and operationalizing a compliance culture that passes DOJ muster

• Assessing your compliance controls in an era of remote and hybrid work

• Where does FCPA compliance intersect with data privacy compliance requirements?

• How to evaluate your training and controls by means other than audits

• Ensuring that your program is aligned on paper and in practice

Pharmaceuticals, Inc.

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FOR

THE LIFE SCIENCES INDUSTRY

1:00  Networking Luncheon

2:15  APAC MARKET-HYPOTHETICALS AND AUDIENCE POLLING

China and The Region's Fast-Changing Life Sciences Business Landscape: The Top 5 Most Vexing Questions and Practical Tips for Navigating Grey Areas

The life sciences market in Asia Pacific remains strategically important with its predicted growth and market size. However, the business environment in markets such as China, Japan and Korea will continue to shift due to geopolitical tensions, macroeconomic and policy changes. To help build or maintain a successful life sciences business in the region, what compliance questions should multinationals be aware of about the realities of operating in Asia, and navigating known and unknown risk factors?

• We examine the structural rapid transformation taking place in the healthcare systems of China and in the rest of Asia, and critical compliance implications for life science companies such as pricing, reimbursement and market access issues

• A view from the ground – we discuss the latest legal developments and the most critical or common compliance risks faced by multinational Life Sciences companies operating in Asia

• Navigating WeChat and WhatsApp communication landmines: Document sharing, data retention

• Data protection and blocking statutes in China: Balancing these laws with DOJ and SEC expectations for FCPA compliance

• What go-to-market considerations are most important in crafting a winning strategy in response to rapid health reforms taking place in Asia?

• How multinationals are evolving their programs in response to global trade tensions relating to China

Ashley Watson

General Counsel, Medical Devices Johnson & Johnson

David Ralston

Senior Vice President Deputy General Counsel

Taysha Gene Therapies

Yuet Ming Tham

Global Co-Head, White Collar, Litigation & Investigations

Sidley Austin LLP (Hong Kong/Singapore)

Janice Wang

Senior Anti-Corruption Counsel Gilead Sciences

Irene Chiu

Senior Vice President, General Counsel MicroPort Orthopedics

Speakers Agenda - Day 1 Agenda - Day 2 Venue Accreditation Become a Sponsor About Us Pricing REGISTER AmericanConference.com/FCPA-Life-Sciences | twitter: @ACI_Conferences linkedin: ACI: Anti-Corruption / FCPA – Legal, Regulatory and Compliance Professionals 7 Part of C5 Group’s ANTI-CORRUPTION GLOBAL SERIES FCPA & ANTI-CORRUPTION

FOR THE LIFE SCIENCES INDUSTRY

3:15

Employee Compensation and Clawbacks: Compliance Program Best Practices Amid Increased DOJ Oversight

DOJ will be evaluating companies’ compliance programs to see whether they use positive and negative compensation incentives to create a compliance culture. How should life sciences companies be structuring their employee compensation packages accordingly and better position themselves in the event of a DOJ inquiry or investigation?

• Compensation arrangements for positions that pose higher risks of compliance issues:

» Senior executives

» Sales professionals who interact with HCPs

» Sales professionals who frequently interact with HCPs who are government officials

• Implementing compensation structures that reward and incentivize compliant behavior

» Considering compliance-promoting behavior during employee performance reviews

• Incorporating compensation structures that penalize compliance failures: Clawbacks

• Integrating compliance efforts into company functions

» Compensation committees

» Employee performance evaluations

4:15  Networking Break

Scott Hollander

Assistant General Counsel - Compliance, Investigations and Litigation

Dr. Reddy's Laboratories

Brockton B. Bosson Partner

Cahill Gordon & Reindel LLP

Thaddeus McBride

Partner

Bass Berry & Sims PLC

Mark Mendelsohn

Partner

Paul, Weiss, Rifkind, Wharton & Garrison LLP

Kristine Mueller

Director, Global Compliance Operations

Arthrex

Speakers Agenda - Day 1 Agenda - Day 2 Venue Accreditation Become a Sponsor About Us Pricing REGISTER AmericanConference.com/FCPA-Life-Sciences | twitter: @ACI_Conferences linkedin: ACI: Anti-Corruption / FCPA – Legal, Regulatory and Compliance Professionals 8 Part of C5 Group’s ANTI-CORRUPTION GLOBAL SERIES FCPA & ANTI-CORRUPTION

FOR THE LIFE SCIENCES INDUSTRY

4:30  BRAZIL-HYPOTHETICALS AND AUDIENCE POLLING

New Compliance Challenges for the Life Sciences Industry in Brazil: Market Entry Due Diligence for Public/Private

Amid the election in Brazil and a shifting compliance and enforcement landscape, don't miss this in-depth, practical session on new, emerging issues, including:

• How to effectively tailor your compliance program, while ensuring appropriate baseline standards globally

• How to run a profitable business without falling a foul of local legislation

• Evolving enforcement priorities on anti-bribery, penalty trends and key takeaways from local and international cases

• Data localization and cross-border data transfers: How to cooperate with foreign government investigations or conduct internal investigations within data privacy boundaries

• How multinationals are evolving their compliance programs in response to local political tensions

Campos Mello Advogados in cooperation with DLA Piper (Brazil)

Lilian Lustre

Head of Ethics and Business Integrity, LATAM Sanofi

Liana Cunha

Compliance Director, Latin America

Thermo Fisher Scientific

5:30  Close of Day One

Speakers Agenda - Day 1 Agenda - Day 2 Venue Accreditation Become a Sponsor About Us Pricing REGISTER AmericanConference.com/FCPA-Life-Sciences | twitter: @ACI_Conferences linkedin: ACI: Anti-Corruption / FCPA – Legal, Regulatory and Compliance Professionals 9 Part of C5 Group’s ANTI-CORRUPTION GLOBAL SERIES FCPA & ANTI-CORRUPTION
Ricardo Caiado Partner Ventures

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

9:30

Adam Yoffie Senior Corporate Counsel, Litigation and Government Investigations

Bristol Myers Squibb

Channing Landreth Associate Vice President, Managing Counsel LabCorp

Ja Moon Vice-President, Healthcare Legal and Compliance Alector

Jennifer Saperstein Partner Covington & Burling LLP

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

James M. Koukios Partner Morrison & Foerster LLP

Brian Kowalski Partner

Latham & Watkins LLP

Maria Villanueva Sessions

Vice President, Compliance Officer, and Head of HR Ra Medical Systems

Speakers Agenda - Day 1 Agenda - Day 2 Venue Accreditation Become a Sponsor About Us Pricing REGISTER AmericanConference.com/FCPA-Life-Sciences | twitter: @ACI_Conferences linkedin: ACI: Anti-Corruption / FCPA – Legal, Regulatory and Compliance Professionals 10 Part of C5 Group’s ANTI-CORRUPTION GLOBAL SERIES FCPA &
ANTI-CORRUPTION FOR THE LIFE SCIENCES INDUSTRY

FOR 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.

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.

Paul Hasting

Aimmune

Member, Board of Directors, Shield Therapeutics plc

Jennifer Zerm Chief Compliance Officer Fortive Corporation

Speakers Agenda - Day 1 Agenda - Day 2 Venue Accreditation Become a Sponsor About Us Pricing REGISTER AmericanConference.com/FCPA-Life-Sciences | twitter: @ACI_Conferences linkedin: ACI: Anti-Corruption / FCPA – Legal, Regulatory and Compliance Professionals 11 Part of C5 Group’s ANTI-CORRUPTION GLOBAL SERIES FCPA & ANTI-CORRUPTION
Darshak S. Dholakia Partner Dechert LLP J. Patrick Rowan Partner McGuireWoods Gary Giampetruzzi Partner Daryl Kreml Chief Compliance Officer Sage Therapeutics Fabiana Lacerca-Allen Senior Vice President, Chief Compliance Officer

FOR THE LIFE SCIENCES INDUSTRY

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

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

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, Compliance - Commercial Divisions Stryker

Speakers Agenda - Day 1 Agenda - Day 2 Venue Accreditation Become a Sponsor About Us Pricing REGISTER AmericanConference.com/FCPA-Life-Sciences | twitter: @ACI_Conferences linkedin: ACI: Anti-Corruption / FCPA – Legal, Regulatory and Compliance Professionals 12 Part of C5 Group’s ANTI-CORRUPTION GLOBAL SERIES FCPA & ANTI-CORRUPTION
12:15
Marilyn Batonga Partner Baker & McKenzie LLP Naana Frimpong Partner DLA Piper Markus Green Vice President and Assistant General Counsel, Government Relations Pfizer

FOR THE LIFE SCIENCES INDUSTRY

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

David H. Resnicoff Partner

Riley Safer Holmes & Cancila LLP

Kathryn Jenne

Senior Counsel, Global Healthcare Compliance

Abbott

Kevin Espinoza Chief Integrity Officer

Kaleo

Mara Senn Executive Global Compliance Leader GE Healthcare

Speakers Agenda - Day 1 Agenda - Day 2 Venue Accreditation Become a Sponsor About Us Pricing REGISTER @ACI_Conferences FCPA & ANTI-CORRUPTION

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.

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CONTINUING LEGAL EDUCATION CREDITS

Accreditation will be sought in those jurisdictions requested by the registrants which have continuing education requirements. This course is identified as nontransitional for the purposes of CLE accreditation.

ACI certifies this activity has been approved for CLE credit by the State Bar of California.

ACI certifies this activity has been approved for CLE credit by the New York State Continuing Legal Education Board.

ACI has a dedicated team which processes requests for state approval. Please note that event accreditation varies by state and ACI will make every effort to process your request.

Questions about CLE credits for your state? Visit our online CLE Help Center at www.americanconference.com/accreditation/cle/

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FOR THE LIFE SCIENCES INDUSTRY
EARN CLE CREDITS

CONTINUING PROFESSIONAL EDUCATION CREDITS

American Conference Institute is registered with the National Association of State Boards of Accountancy (NASBA) as a sponsor of Continuing Professional Education (CPE) on the National Registry of CPE Sponsors. State Boards of Accountancy have final authority on the acceptance of individual courses for CPE credit. Complaints regarding registered sponsors may be submitted to the National Registry of CPE Sponsors through its website: www.nasbaregistry.org

Course Objective:

• Life Sciences and the Continuing Compliance Challenges of Ephemeral Messaging: DOJ’s Increasing Oversight and How to Resolve the Most Complex Dilemmas

• Clinical Trials: The Latest on Managing Unique, Evolving Bribery Risk Factors for Sponsors and CROs

• Life Science-Specific Considerations for Measuring the Effectiveness of Compliance Programs: Real-World Takeaways for Pressure-Testing Your Program Amid the Latest DOJ Guidance and Enforcement Posture

• China and The Region's Fast-Changing Life Sciences Business Landscape: The Top 5 Most Vexing Questions and Practical Tips for Navigating Grey Areas

• Employee Compensation and Clawbacks: Compliance Program Best Practices Amid Increased DOJ Oversight

• New Compliance Challenges for the Life Sciences Industry in Brazil: Market Entry Due Diligence for Public/Private Ventures

• 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

• Russia Sanctions and the Unique Challenges for Global Life Science Companies

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

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

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

Field of Study: Business Law

Prerequisite: None

Level of knowledge: Basic Advanced Preparation: None

WHO SHOULD ATTEND:

In-House Investigations & Compliance Counsel, General Counsel, Chief Legal Officer, VP/Director –Anti-Corruption, Compliance & Ethics, Partners from Law, Investigations and Accounting Firms

TEACHING METHOD: Group Live and Group Internet Based

DELIVERY METHOD: Group Live and Group Internet Based Participants will earn up to 12.0 CPE credits for the main conferences.

Group Internet Based Participants, please note: To be awarded full credits, you must actively participate in activities (such as polling) and submit the verification codes presented in the chat. For more information and to submit your CPE request visit: https://www.americanconference.com/accreditation-instructions-for-virtual-attendance/#CPE.

Refunds and Cancellations: Requests for credit memos or refunds must be received in writing by April 30, 2023 and will be subject to a cancellation fee. No refunds will be granted after April 30, 2023. For more information regarding refund, complaint, and/or program cancellation policies please contact our offices at 1-888-224-2480.

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THE
ANTI-CORRUPTION FOR
LIFE SCIENCES INDUSTRY

FOR THE LIFE SCIENCES INDUSTRY

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Speakers Agenda - Day 1 Agenda - Day 2 Venue Accreditation Become a Sponsor About Us Pricing REGISTER AmericanConference.com/FCPA-Life-Sciences | twitter: @ACI_Conferences linkedin: ACI: Anti-Corruption / FCPA – Legal, Regulatory and Compliance Professionals 17 Part of C5 Group’s ANTI-CORRUPTION GLOBAL SERIES FCPA & ANTI-CORRUPTION
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FOR THE LIFE SCIENCES INDUSTRY

ABOUT US

The C5 Group, comprising American Conference Institute, The Canadian Institute and C5 in Europe, is a leading global events and business intelligence company.

For over 30 years, C5 Group has proVided the opportunities that bring together business leaders, professionals and international experts from around the world to learn, meet, network and make the contacts that create the opportunities.

Our conferences and related products connect the power of people with the power of information, a powerful combination for business growth and success.

Speakers Agenda - Day 1 Agenda - Day 2 Venue Accreditation Become a Sponsor About Us Pricing REGISTER AmericanConference.com/FCPA-Life-Sciences | twitter: @ACI_Conferences linkedin: ACI: Anti-Corruption / FCPA – Legal, Regulatory and Compliance Professionals 18 Part of C5 Group’s ANTI-CORRUPTION GLOBAL SERIES FCPA & ANTI-CORRUPTION

PLEASE NOTE THE FOLLOWING PANDEMIC-RELATED PROTOCOLS: ACI conferences and events will be organized in accordance with the latest health and safety regulations, guidelines, and recommendations, directed by the CDC and local government authorities. Attendees are advised to consider their personal health needs.

Attendees are asked to self-screen in the days leading up to, before and after attending an ACI event and/or conference.

We will continue to monitor the health situation and relevant authorities. Changes to health and safety measures may be made by ACI at any time as required.

Speakers Agenda - Day 1 Agenda - Day 2 Venue Accreditation Become a Sponsor About Us Pricing REGISTER AmericanConference.com/FCPA-Life-Sciences | twitter: @ACI_Conferences linkedin: ACI: Anti-Corruption / FCPA – Legal, Regulatory and Compliance Professionals 19 Part of C5 Group’s ANTI-CORRUPTION GLOBAL SERIES FCPA & ANTI-CORRUPTION FOR THE LIFE SCIENCES INDUSTRY Register and pay to lock in your early rate and be eligible for a full refund until April 28, 2023. If you are unable to attend for any reason, you will have the following options: y A full credit note for you, or a colleague to attend another event. y A full refund. All cancellations and changes must be submitted to customerservice@americanconference.com by April 28, 2023. WORRY FREE Registration GUARANTE E BOOK WITH CONFIDENCE! Looking to Register? Contact our Customer Service Representatives: Yanette Ching, American Conference Institute Y.Ching@AmericanConference.com 1 212 352 3220 x5499 Use Registration Code: B00-999-YCG23   Brian Currie, American Conference Institute B.Currie@AmericanConference.com 1 212 352 3220 x7370 Use Registration Code: B00-999-BCE23   CONFERENCE CODE: 875L23-NYC PRICING Register & Pay by March 10, 2023 Register & Pay by April 7, 2023 Register & Pay after April 7, 2023 In-Person Conference $1995 $2195 $2295 Bringing a Team?* 3–4 10% Conference Discount 5–6 15% Conference Discount 7 20% Conference Discount 8+ Call 888-224-2480 Special Discount ACI offers financial scholarships for government employees, judges, law students, non-profit entities and others. For more information, please email or call customer service. To update your contact information and preferences, please visit https://www.AmericanConference.com/preference-center/. Terms & conditions and refund/cancellation policies can be found at AmericanConference.com/company/faq/ All program participants will receive an online link to access the conference materials as part of their registration fee. Additional copies of the Conference Materials available for $199 per copy. *Team/group registrations are for in-person only and must be from the same organization/firm and register together in one transaction.
© American Conference Institute, 2023

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