19th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry - DS

19th Advanced Forum on

& ANTI-CORRUPTION FOR THE LIFE SCIENCES

INDUSTRY May 9–10 • New York Bar Association, New York, NY

Derek Ettinger

FIRESIDE CHAT WITH DISTINGUISHED 2024 CO-CHAIRS

Assistant Chief, FCPA Unit, Fraud Section, Criminal Division

U.S. Department of Justice

MEET AND BENCHMARK WITH SENIOR EXECUTIVES FROM:

Fresenius

Bristol Myers Squibb

Eli Lilly and Company

Johnson & Johnson

Gilead Sciences

General Electric

GE Healthcare

Takeda

3M Healthcare

Dentsply Sirona

Thermo Fisher Scientific

Align Technology

Ionis Pharmaceuticals

ICON Plc (Ireland)

Stryker

Ra Medical Systems

Charles Cain Chief, FCPA Unit U.S. Securities and Exchange Commission

Zimmer Biomet

Siemens Healthineers

Cook Group Inc. and Cook Medical Foundation Medicine

CDx Diagnostics Novartis

Medtronic IQVIA (UK)

Claudius O. Sokenu

Executive Vice President, Chief Legal and Compliance Officer, Corporate Secretary Avantor

Natasha Trifun

Executive Director, Head of Compliance, R&D, Global Medical, External Funding and Global Functions

Alexion Pharmaceuticals

NEW,

PRACTICAL SESSIONS:

Share-All NEW DOJ/OIG COMPLIANCE BEST PRACTICES: Putting DOJ and HHS-OIG Compliance Program Protocols into Action

Share-All VOLUNTARY DISCLOSURES: Understanding “Prompt Reporting”, Cooperation Credit, Remediation and When to Engage Outside Counsel

Share-All M&A AND JOINT VENTURE DUE DILIGENCE: High-Stakes Decision-Making Around DOJ’s Safe Harbor Policy and Post-Transaction Integration

MORE INTERNATIONALLY FOCUSED DISCUSSIONS:

Share-All NEW COMPLIANCE CHALLENGES FOR LATIN AMERICA: Brazil, Colombia and Mexico Market Entry Due Diligence for Public/Private Ventures

Share-All CHINA: The Anti-Corruption Crackdown and Managing High Stakes Nightmare Scenarios

Share-All EMERGING MARKET ENTRY-HYPOTHETICALS: Data Localization and Cross-Border Data Transfers, Investigative Trends

Supporting Sponsor

Associate Sponsors

GOVERNMENT SPEAKER

Derek Ettinger

Assistant Chief, FCPA Unit, Fraud Section, Criminal Division

U.S. Department of Justice

DISTINGUISHED SPEAKER FACULTY

Ash Aggarwal

Principal, Global Commercial Compliance

IQVIA (UK)

Matt Couillard

Vice President, Product Development

TDI

Charles Cain

Chief, FCPA Unit

U.S. Securities and Exchange Commission

2024 CO-CHAIRS

Claudius O. Sokenu

Executive Vice President, Chief Legal and Compliance

Officer, Corporate Secretary

Avantor

Natasha Trifun

Executive Director, Head of Compliance, R&D, Global Medical, External Funding and Global Functions

Alexion Pharmaceuticals

Marcus A. Asner

Partner

Arnold & Porter

Liana Cunha

Compliance Director, Latin America

Thermo Fisher Scientific

Martine M. Beamon

Partner

Davis Polk & Wardell LLP

Gwen Chapman

Chief Compliance Officer

Illumina Inc.

Joshua Drew

Partner

Miller & Chevalier Chartered

Corey Dunbar

Managing Director

BDO

Jennifer Chunias

Partner

Goodwin Proctor LLP

Andrew Cliver

Head of Compliance, North America

Siemens Healthineers

Adam Falkowitz

Head of Legal, North America

Getinge

Ciara Farrell

Vice President, Associate General Counsel and

Global Head of Ethics and Compliance

ICON Plc (Ireland)

SPEAKER FACULTY

Esther Flesch Partner

Miguel Neto Advogados (Brazil)

Christina Hud

Global Investigations Senior Compliance Counsel Pfizer

Former Acting Chief & Senior Trial Counsel, Health Care Fraud Unit, U.S. Department of Justice

Juan Luis Fuentes

Director, Healthcare Compliance, Government Affairs & Policy

Johnson & Johnson

Gene Ingoglia Partner

A&O Shearman

Daniel Grooms

Partner

Cooley LLP

Former Assistant United States Attorney and Criminal Chief, U.S. Department of Justice

Susanne M. Hanchar

Associate Vice President – Global Ethics and Compliance, Anti-Corruption & Investigations

Eli Lilly and Company

Jay Holtmeier Partner

WilmerHale

Mason Hubbard

Senior Anti-Corruption Counsel

Gilead Sciences

Brian Kowalski Partner

Latham & Watkins

Angela Main

Senior Vice President, Global Chief Compliance Officer & Associate General Counsel, Asia Pacific

Zimmer Biomet (USA)

Tatiana Martins Partner

Davis Polk & Wardwell LLP

David Last Partner

Cleary Gottlieb Steen & Hamilton LLP

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

Rebekah Latchis

Global Chief of Staff, Governance and Planning, Office of Ethics and Compliance

Medtronic

Leon C. G. Liu

Partner, Head of Government Enforcement and Investigations

JunHe LLP (China)

Lamia Matta

Global Head of Investigations

3M Healthcare Gina Nese

Vice President, Associate General Counsel Compliance and Privacy Officer

Align Technology Drew Northern

Vice President, Chief Ethics and Compliance Officer Cook Group Inc. and Cook Medical

Rebecca Orttel

Vice President, Chief Ethics and Compliance Officer

Medtronic

Tracy Palmer Berns

Senior Vice President, Chief Compliance &

Quality Assurance Officer

Ionis Pharmaceuticals

Michael Pacella

Vice President, Chief Ethics and Compliance Officer

Dentsply Sirona

Mara Senn

Executive Global Compliance Leader

GE Healthcare

Former Trial Attorney, Criminal Division, U.S. Department of Justice

Ericka Watson Founder

Data Strategy Advisors

Sergio Pinto

Senior Director, Regional Sector Lead

Johnson & Johnson

Margaret Price

Vice President, Chief Compliance Officer

Atricure

Maria Villanueva Sessions

Vice President, Compliance Officer

Ra Medical Systems

Dan Spicehandler

Vice President, Compliance - Commercial Divisions

Stryker

Olivia Radin

Partner

King & Spalding LLP

Ryan Rohlfsen Partner

Ropes & Gray LLP

Former Senior Trial Attorney, Criminal Division, U.S. Department of Justice

Gina Salcedo Lannin

Manager, Insights and Analytics

Takeda

Jonathan Stevens Partner

Paul Hastings, LLP

Yuet Tham

Partner

Sidley Austin (Singapore/Hong Kong)

Nicole Willms Partner

Pohlmann & Company (Germany)

Adam Yoffie

Executive Director, Head of C&E Investigations and Integrity Line

Bristol Myers Squibb

Former Trial Attorney, Criminal Division, U.S. Department of Justice

Raquel Zambrano de Leon

Ethics, Risk & Compliance, Innovative Medicines

Head for Canada and Latin America Novartis

Rina Vazirani

Associate General Counsel

& Senior Director

Gilead Sciences

Terri Segura

Vice President, Global Compliance Investigations

Zimmer Biomet

CONFERENCE

MAY 9, 2024

9:45  NEW DOJ/OIG COMPLIANCE BEST PRACTICES

Putting Protocols into Action: Key Differences, Potential Pitfalls, and New Implementation Hurdles

Amid continuing increased DOJ enforcement postures, and newly introduced U.S. Department of Health and Human Services (OIG) compliance program guidelines, how are life science multinationals designing compliance program updates to meet both DOJ/OIG expectations? What are the key differences and compliance nuances between these two compliance program guidance measures and what are the critical implementation tips, tools, and roadblocks to look out for?

Hubbard Senior Anti-Corruption Counsel Gilead Sciences

Gwen Chapman Chief Compliance Officer Illumina Inc.

10:45

Extended Networking Break

11:15  CHINA HYPOTHETICALS

The Anti-Corruption Crackdown in China and Nightmare Scenarios: How Companies Are Now Approaching High Stakes, Intensifying Legal and Compliance Risks

Building upon the pre-conference workshop, this interactive, practical session delves select, highly complex issues affecting the life sciences and healthcare sectors in China. Benefit from enhanced benchmarking by using our anonymous polling systems!

• The anti-corruption crackdown in China: How might this campaign negatively impact HCPs and advances in healthcare?

• Critical regional compliance implications for life science companies such as pricing, reimbursement, and market access issues

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

• Data protection and blocking statutes: 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 China?

Adam Yoffie

Executive Director, Head of C&E Investigations and Integrity Line

Bristol Myers Squibb

Former Trial Attorney, Criminal Division, U.S. Department of Justice

Susanne M. Hanchar

Associate Vice President –Global Ethics and Compliance, Anti-Corruption & Investigations

Eli Lilly and Company

Lamia Matta Global Head of Investigations

3M Healthcare

Yuet Tham Partner

Sidley Austin (Singapore/Hong Kong)

Mason

Margaret Price Vice President, Chief Compliance Officer

Atricure

Gene Ingoglia Partner

A&O Shearman

12:00  Life Science M&A/Joint Ventures: High-Stakes Decision-Making Around DOJ’s Safe Harbor Policy, Due Diligence, Privacy and Post-Transaction Integration

• DOJ's M&A Safe Harbor Policy: Steps to take when you discover FCPA violations

» The benefits and practicalities behind self-disclosure:

ƒ Specific requirements as to the timing of disclosure and remediation

ƒ Remediation and restitution: Potential criminal exposure at the target company

ƒ What constitutes a “reasonableness analysis?”

ƒ Misconduct discovered during “bona fide, arms-length M&A transactions”

• Spinoff mergers:

» Assessing the scope of risk relative to whole company acquisitions

» Allocating assets and liabilities between the parties

» Third party and regulatory consents

1:00  Networking Luncheon

Dan Spicehandler Vice President, Compliance- Commercial Divisions Stryker

Natasha Trifun

Executive Director, Head of Compliance, R&D, Global Medical, External Funding and Global Functions

Alexion Pharmaceuticals

Joshua Drew

Partner

Miller & Chevalier Chartered

2:15  Leveraging Emerging Technology in Life Sciences Operations: Detecting FCPA Data Triggers and Other Data-Driven Fraud Anomalies with Data Automation, Data Analytics and Artificial Intelligence

Incorporating data analytics into your compliance program has instantly changed from a “nice to have” to a “must have” element of your program. This session on data monitoring, data analytics and AI for life sciences will provide you with practical knowledge about outsourcing or implementing your own data analytics platform. Ensure the right questions are being asked of your data to gather the right information to get to the right answers.

• Effective ways to automate, including when your company has multiple, different systems

• Ensuring that data feeds and monitoring tools are working in real time

• Developing processes for determining if an internal investigation is necessary and any additional action

• Identifying which transactions to monitor and how to monitor them, including gifts and donations

• Deciding which pre-approval systems need to be set up before rolling out a monitoring program

• Understand how data analytics interactions affect your risk profile

• Measuring data analytics effectiveness on spotting FCPA data triggers

• Build it or buy it?

• See real-world examples of the impact of data analytics/AI/Machine learning on life sciences compliance

Practical Implications of the U.S. Department of Justice’s M&A

On Oct. 4, 2023, Deputy Attorney General (DAG) Lisa Monaco announced a new Department of Justice policy intended to incentivize acquiring companies to voluntarily self-disclose criminal misconduct uncovered during a merger or acquisition. But it comes with a caveat that could have more of a chilling effect on

Gina Salcedo Lannin Manager, Insights and Analytics Takeda

Corey Dunbar Managing Director BDO

3:00  Compensation Clawbacks in the Life Sciences Context: The Latest on Resolving

Compliance

Dilemmas, Implementation Challenges and Conflicts with International Employment Law

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

• Multi-jurisdictional, international clawback implications:

» U.S. jurisdictions: Navigating different definitions and interpretations of what kinds of compensation constitute “wages.”

» Resolving conflicts between U.S. and foreign employment law

• Implementing compensation structures that reward and incentivize compliant behavior

• Integrating compliance efforts into company functions

» Compensation committees

» Employee performance evaluations

» Who will be administering the protocols?

Tatiana Martins Partner

Davis Polk & Wardwell LLP

Christina Hud

Global Investigations Senior Compliance Counsel

Pfizer

Former Acting Chief & Senior Trial Counsel, Health Care Fraud Unit

U.S. Department of Justice

Adam Falkowitz

Head of Legal, North America Getinge

3:45  Networking Break

4:00  CASE STUDY

Navigating Discounts Through Distribution Networks

• Pre-deal contract modeling

• Managing complex performance agreements

• Aggregating distributor payments

• Payment reporting, analytics and calculations

• Controls around inflated margins: How to design appropriate discounts for distributors and sub-distributors

Mara Senn

Executive Global Compliance Leader

GE Healthcare

Former Trial Attorney, Criminal Division, U.S. Department of Justice

4:30  Challenges for Latin America and the Life Sciences Industry: Market Entry Due Diligence for Public/Private Ventures

Topics will include:

• Public versus private doctors and handling their specific FCPA issues

• Mexico

» AMID and regional codes of ethics and transparency with HCPs

• Brazil:

» ABAC and other legal standards that need to be on your radar: Fostering ethics and integrity in the market/society amid public sales law

» Interfarma and ABIMED: Regional codes of ethics

• Colombia:

» Specific laws and requirements: SAGRILAFT and Business Transparency and Ethics Program (PTEE), Colombian legal regulations

» ANDI HCP codes of ethics and transparency

5:30  Close of Day One

Networking Cocktail

Liana Cunha Crespo

Compliance Director, Latin America

Thermo Fisher Scientific

Sergio Pinto

Senior Director, Regional Sector Lead Johnson & Johnson

Esther Flesch Partner

Miguel Neto Advogados (Brazil)

CONFERENCE DAY TWO FRIDAY, MAY 10, 2024

8:45  Opening Remarks from the Co-Chairs

Claudius O. Sokenu

Executive Vice President, Chief Legal and Compliance Officer, Corporate Secretary Avantor

Natasha Trifun

Executive Director, Head of Compliance, R&D, Global Medical, External Funding and Global Functions Alexion Pharmaceuticals

9:00  New International Life Science Anti-Corruption Compliance Considerations: Measuring and Testing Top-Down Effectiveness and Individual/Corporate Transparency of Compliance Controls

Amid increased global enforcement postures and compliance program standards, it is critical that multinational life sciences companies ensure that their programs are pressure-tested (and re-tested) toward mitigating individual/corporate liability risks and strengthening corporate culture.

• Global anticorruption enforcement efforts and comparisons to the FCPA:

» The UK Economic Crime and Corporate Transparency Act

» EU Anti-Corruption Directive

• The interplay of GDPR with anti-corruption compliance efforts

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

• Where do global anti-corruption efforts 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

Ash Aggarwal

Principal, Global Commercial Compliance IQVIA (UK)

Ciara Farrell

Vice President, Associate General Counsel and Global Head of Ethics and Compliance ICON Plc (Ireland)

Nicole Willms Partner Pohlmann & Company (Germany)

Leon C. G. Liu

Partner, Head of Government Enforcement and Investigations JunHe LLP (China)

9:45  Third Party Management: Monitoring Distributors, Sub-Distributors, Sub-Dealers and Sales Agents

The tools required for effective third-party management for life sciences companies continue to change. Added to this is the reality that certain jurisdictions present unique, heightened risks and obstacles to tailoring your program to each specific context. This session will allow candid discussion and life-science-specific benchmarking around third-party risks and evolving compliance and geopolitical realities.

• Updating best practices for a risk-based program tailored to a specific country/region

• Strengthening contractual agreements with distributors and sub-distributors

• When and how much to train distributors and sub-distributors

• Strengthening your due diligence with tier one and tier two distributors and resellers and contractual risk flagging process and procedures

• How to vet distributor past-history around prior accusations, improper affiliations, and the strength of their own compliance programs

• On the ground obstacles to monitoring third party conduct, including distribution and sub-distribution networks

• Knowing how far down the supply chain to go: When to stop

• Concrete examples of addressing resistance to follow-up questions after an initial questionnaire

Michael Pacella

Vice President, Chief Ethics and Compliance Officer

Dentsply Sirona

Drew Northern

Vice President, Chief Ethics and Compliance Officer

Cook Group Inc. and Cook Medical

Matt Couillard

Vice President, Product Development

TDI

Jonathan Stevens Partner

Paul Hastings, LLP

10:30  Networking Break

Media Partners

10:45  Cross-Border Data Privacy & Cyber Breaches: False Claims Act (FCA) Liability, Cyber Breach Security and China’s New PIPL Measures-and the Interplay with Anti-Corruption

With the vast amounts of data stored on servers and in the cloud, and the ever-increasing sophistication of threat actors, life science organizations must contend with a complex multinational regime of data protection laws. The sheer number of them — and the differences in definitions, standards and exceptions between them — presents a challenge for an organization when a data breach occurs.

• Complying with the GDPR’s breach notification obligations

• US: Navigating a handful of federal laws, including breach notification provisions

• UK Data Protection Act

• Brazil’s data protection regime (LGPD)

• Navigating China’s 2023 update of its Personal Information Protection Law (PIPL)

• DOJ's Civil Cyber Fraud Initiative: Using the FCA to enforce cyber requirements

• Cyber breach security and prevention, particularly for medical device companies:

» Reviewing remote access protocols

» Segmenting data into different networks

» Understanding ransomware demands and reporting

Gina Nese Vice President, Associate General Counsel Compliance and Privacy Officer Align Technology

Marcus A. Asner Partner

Arnold & Porter

Ericka Watson Founder

Data Strategy Advisors

Voluntary Disclosures: Understanding “Prompt Reporting”, Cooperation Credit, M&A Safe Harbor, Remediation and When to Engage Outside Counsel

During this highly anticipated session, gain invaluable insights from former DOJ officials, leading private and in-house practitioners on how to update your disclosure calculus in the wake of recent DOJ announcements. Topics will include:

• To disclose or not disclose

• What constitutes “a reasonably prompt time” to disclose?

• The extent of possible cooperation credit-and what is now expected amid recent DOJ policy and guidance updates

David Last Partner

Cleary Gottlieb Steen & Hamilton LLP

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

Daniel Grooms

Partner

Cooley LLP

Former Assistant United States

Attorney and Criminal Chief, U.S. Department of Justice

Claudius O. Sokenu

Executive Vice President, Chief Legal and Compliance Officer, Corporate Secretary Avantor

Jay Holtmeier

Partner

WilmerHale

Networking Luncheon

1:45  The Grey Areas of G&E, Donations, Sponsorship and Hospitality in High-Risk Markets: What Companies are Now Doing to Strengthen Risk Monitoring Around Compliant HCP Relations

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

• Virtual calls, mobile app meetings and their associated compliance risks, as well as the value of engaging HCPs on the virtual stage

• Using HCPs as social media influencers

• Sending HCPs to industry conferences

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

• How companies are operationalizing controls around HCP conflicts of interest

How to Handle Whistleblower Complaints: Best Practices Amid a Spike in FCPA-Related Complaints

• Trends and specific challenges related to FCPA-related whistleblower complaints

• Step-by- action plan for handling the complaint, interviews and litigation risk

• Whistleblowers that continue to bring False Claims Act actions against life sciences companies, particularly those that lack the fundamental controls necessary to comprise adequate healthcare fraud and abuse compliance programs

• Asia Pacific-related whistleblower report trends: Meeting confidentiality obligations and local law requirements

• Whistleblower risks when implementing reductions in the workforce

the Life Sciences Sector

» fostering internal, rather than external, reporting

» encouraging individuals to report centrally, while ensuring that the worker also has the option to report locally

» Retaliation:

ƒ retaliations including “psychiatric or medical referrals”

ƒ continuing to monitor its relationship with a whistleblower and to keep records of management decisions

2:45

Andrew Cliver Head of Compliance, North America Siemens Healthineers

Brian Kowalski Partner Latham & Watkins

Rina Vazirani Associate General Counsel & Senior Director Gilead Sciences

Olivia Radin Partner King & Spalding LLP

• EU Whistleblower Protection Directive: Key Considerations for

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

• Use of emojis as an emerging messaging risk: Corporate malfeasance and cross-cultural complications

• 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 or prohibit the 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

• The corruption landscape in key emerging markets, including recent headlines and scandals

• China’s new laws and regulations aimed at both bribe payors and recipients

• India’s slew of legislative and regulatory developments impacting compliance requirements and investigative procedures

• Africa’s anti-corruption enforcement trends and how they are threatened by an uptick in political transitions

• The importance of including key contractual provisions and audit rights and mechanisms

Terri Segura

Martine M. Beamon Partner Davis Polk & Wardell LLP

Maria Villanueva Sessions

Angela Main

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