25th Annual Conference on Drug & Medical Device Litigation

Join us virtually as we celebrate our 25th year anniversary.

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25th Annual Conference on

DRUG&MEDICAL DEVICE L I T I G AT I O N

DECEMBER 8 – 9, 2020 (EST) • VIRTUAL CONFERENCE

EARN CLE CREDITS

Benefit from the Insights of 20+ In-House Counsel Including:

Patricia A. Barbieri SVP, General Counsel and Secretary, Legal and Corporate Affairs Daiichi Sankyo

Lead Sponsors

Brennan Torregrossa Senior Vice President, Head of Global Litigation GSK

Charna Gerstenhaber Vice President, Head of Litigation & Investigations Novartis Pharmaceuticals

Supporting Sponsors

Matthew L. Stennes Vice President, Chief Litigation & Investigations Counsel Medtronic

Christopher Guth Senior Assistant General Counsel Bayer

Associate Sponsors

Veronica M. Lei Assistant General Counsel Litigation and Legal Compliance Eli Lilly and Company

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Looking back over the last 25 years of Drug and Med. Join us in our virtual conference room, lounge, and exhibit hall as we celebrate our 25th year of exceptional speakers, exclusive content and unparalleled connections for the life sciences product liability community.

Every year for the past 24 years, ACI's Conference on Drug and Medical Device Litigation has consistently brought together a distinguished faculty of experts, exclusive content and unparalleled networking opportunities.

This one industry-shaping event has consistently allowed counsel for the pharmaceutical and medical device industries a forum to freely exchange ideas,

MASTER LEVEL STRATEGIES

Last year’s event broke records with nearly 500 drug and medical device industry professionals in attendance, and we expect no less of this year’s 25th Anniversary event. We look forward to seeing you online this December!

DISTINGUISHED FACULTY

for Litigators & In-House Counsel 2004

engage in high level discussion, and critical thinking on the latest developments and challenges shaping product liability litigation, including evolving theories behind new claims, the influence of politics, policy and the public in these actions, and guiding principles for minimizing damage in times of crisis.

the best that the bar, the bench, and the industry have to offer 2005

2007

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2010

UNPARALLELED CONNECTIONS

with the who’s who in product liability litigation 2015

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2019

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You Asked, We Listened – New for 2020 lightbulb

COVID-19’s Impact on Drug & Medical Device Litigation

A comprehensive and timely analysis of the implications of PREP Act immunity on future drug and medical device products liability litigation and an assessment of potential COVID-19 related MDLs.

Gavel A View from the Bench – 2020 Edition

Judicial insights on how this year’s unprecedented events have impacted dockets, court functions, judicial proceedings and the JPML in general.

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Virtual Trial Practice Toolkit

Leading trial attorneys share strategies and best practices for conducting virtual/ remote discovery, witness preparation, depositions, mediations, oral arguments and more.

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Special Focus Sessions

Advanced discussions surrounding this year’s changes to FDA approval processes as well as how current events are impacting juror mindsets, perceptions and verdicts in drug and device cases.

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MDL Case Study

HANDSHAKE

Analysis of the unique nuances of three of 2020’s most significant MDLs – Hernia Mesh, Valsartan and Zantac.

EXCLAMATION

Crisis Management Boot Camp

Data Analytics in MDL Management

Understanding how data and analytics from initial census forms are being collected, used and protected, and how they are impacting MDL management, proceedings and judicial decision-making.

Product Recall Do’s and Don’ts

Lessons learned from COVID-19 on strengthening your response capabilities and minimizing business disruption in the face of a company or industry crisis

Gain best practices for coordinating your team and minimizing damage to your company in the face of a nationwide product recall

Interactive Virtual Conference Experience This program is designed to bring the dynamic, in-person conference experience to you virtually with multiple ways to engage with speakers, stay connected with industry peers and expand your professional network through 1-on-1 conversations.

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Virtual Networking Opportunities

Join us for for 1:1 speed networking, exhibit hall meet-ups and virtual speaker meet and greets for lively discussions about product liability litigation during these uncharted times. Bring your bold ideas, stories and strategies to these unique virtual networking opportunities.

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Polling

Weigh in and seize the opportunity to benchmark with industry peers in real-time on leading issues such as sensitive, complex hypothetical scenarios.

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UNIVERSITY

Diversity and Inclusion Town Hall

Let your voice be heard in this unique open floor session on Diversity & Inclusion initiatives and challenges, designed to give all attendees an opportunity to add to the dialogue.

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ACI's Drug and Med Advisory Board American Conference Institute’s Drug and Medical Device Litigation Advisory board was created as a part of ACI’s ongoing effort to provide industry-leading content and a world-renowned speaker faculty. The board is composed of a selection of all-in-house advisers, including General Counsel, Senior Litigation Counsel and Chief Legal Strategists from the leading pharmaceutical and medical device companies in the country and in some cases the world. This ‘inner circle’ counsels ACI on the impact of product liability litigation trends and emerging topics.

Patricia A. Barbieri SVP, General Counsel and Secretary Daiichi Sankyo, Inc. Mary-Alice Barrett Associate Director, Assistant General Counsel Genentech

Donald P. Bunnin Associate Vice President, Senior Counsel – Litigation & Medical Aesthetics Allergan, Inc. Debra L. Burns Senior Counsel Litigation/ Investigations GE Healthcare

Jill Harrison General Counsel Medical Products Division W. L. Gore & Associates, Inc.

Richard W. Silbert V.P., Chief Legal Strategist Purdue Pharma L.P.

Malini Moorthy Vice President and Chief Deputy General Counsel Medtronic

COMMENT-DOTS “There is no better forum for leading edge thinking on today’s most pressing drug and med litigation challenges.”

Director, Government Investigations, Merck & Co., Inc.

#DrugandMed twitter: @ACI_Pharma linkedin: ACI: Drug and Medical Device Litigation

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Distinguished Speakers MEMBERS OF THE JUDICIARY

Honorable Karen K. Caldwell Chief Judge U.S. District Court, E.D. Kentucky Panel Judge, Judicial Panel on Multidistrict Litigation (JPML)

Honorable F. Dennis Saylor, IV Chief Judge U.S. District Court, D. Massachusetts

CO-CHAIRS:

Charna Gerstenhaber Vice President, Head of Litigation & Investigations Novartis Pharmaceuticals (East Hanover, NJ)

Christopher Guth Senior Assistant General Counsel Bayer (Pittsburgh, PA) Sonia Chen Arnold General Counsel- Lilly Oncology Eli Lilly and Company (Indianapolis, IN) Patricia A. Barbieri SVP, General Counsel and Secretary Legal and Corporate Affairs Daiichi Sankyo (Basking Ridge, NJ)

Honorable John R. Tunheim Chief Judge U.S. District Court, D. Minnesota

Honorable Eduardo C. Robreno Senior Judge U.S. District Court, E.D. Pennsylvania

Andrew (Andy) Bayman Partner King & Spalding LLP (Atlanta. GA)

Honorable William F. Highberger Superior Court Judge Los Angeles County Superior Court

Honorable Rex Burlison Circuit Judge 22nd Judicial Circuit of MO

James (Jim) Beck Senior Life Sciences Policy Analyst Reed Smith LLP

Lori Cohen Co-Chair, Global Litigation Chair, Pharmaceutical, Medical Device & Health Care Litigation Group Chair, Trial Practice Group Greenberg Traurig LLP (Atlanta, GA)

Mollie Benedict Partner Tucker Ellis LLP

Paul J. (PJ) Cosgrove Partner Ulmer & Berne LLP (Cincinnati, OH)

Erin Bosman Co-Chair of Class Action and Mass Torts Morrison & Foerster LLP (San Diego, CA)

Howard M. Cyr Assistant General Counsel Teleflex (Wayne, PA)

Michelle M. Bufano Partner Patterson Belknap Webb and Tyler LLP (New York, NY)

Mary-Alice Barrett Associate General Counsel Genentech (Little Falls, NJ)

Matthew A. Campbell Partner, Co-Chair, Product Liability & Mass Torts Practice Winston & Strawn LLP (Washington, DC)

Adam Bassing Associate General Counsel, U.S. Litigation & Global Safety UCB, Inc. (Smyrna, GA)

Robert P. Charrow General Counsel US Department of Health & Human Services (Washington, DC)

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Gabriel Egli Partner Shook Hardy & Bacon LLP (St. Louis, MO) Wendy West Feinstein Partner Morgan, Lewis & Bockius LLP (Pittsburgh, PA) Kristen Fournier Partner King & Spalding LLP (New York, NY)

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Rachel Gallagher Director, Legal Counsel Teva Pharmaceuticals (Horsham, PA) John Galvin Partner Thompson Coburn LLP (St. Louis, Missouri) Ashley Garry Senior Legal Counsel ArTara Therapeutics (Indianapolis, IN) Charna Gerstenhaber Vice President, Head of Litigation & Investigations Novartis Pharmaceuticals (East Hanover, NJ) Mara Cusker Gonazalez Partner Dechert LLP (New York, NY) Christopher Guth Senior Assistant General Counsel Bayer (Pittsburgh, PA) Max Heerman Senior Legal Counsel, Litigation Medtronic (Washington, DC) Jean F. Holloway Senior Vice President, General Counsel, Chief Compliance Officer and Corporate Secretary CryoLife, Inc. (Kennesaw, Georgia) Michael Imbroscio Partner, Co-Chair of the Products Liability & Mass Tort Practice Covington & Burling LLP (Washington, DC)

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Marcela Kirberger General Counsel, Corporate Secretary and Chief Compliance Officer Roche Diagnostics Corporation (Indianapolis, IN)

Megan Pizor General Counsel Litigation Management, Inc. (Mayfield Heights, OH)

Amy Todd Klug Associate General Counsel, Litigation & Corporate Operations, Legal Affairs Daiichi Sankyo, Inc. (Basking Ridge, NJ)

Alan E. Rothman Counsel Sidley Austin LLP (New York, NY)

Paul LaFata Partner Dechert LLP (New York, NY) John P. Lavelle, Jr. Partner Morgan, Lewis & Bockius LLP (Philadelphia, PA)

Richard W. Silbert VP, Chief Legal Strategist Purdue Pharma L.P. (Stamford, CT) Adam Spicer Partner King & Spalding LLP (Atlanta, GA)

Julie M. Lewis General Counsel & Corporate Secretary Carestream Health (Rochester, NY)

Matthew L. Stennes Vice President, Chief Litigation & Investigations Counsel Medtronic (Minneapolis, MN)

Veronica M. Lei Assistant General Counsel – Litigation and Legal Compliance Eli Lilly and Company (Indianapolis, IN)

Carly W. Stephani Principal Litigation Counsel Litigation & Global Investigations Medtronic (Minneapolis, MN)

Buffy Mims Partner Shook Hardy & Bacon LLP (Washington, DC)

Sheea Sybblis Associate General Counsel Nestle Health Science (New York, NY)

Marilyn Moberg Partner Reed Smith LLP (Los Angeles, CA)

Sarah Thompson Partner Greenberg Traurig LLP (Atlanta, GA)

Sarah Padgitt Associate General Counsel Baxter (Deerfield, IL)

Brennan Torregrossa Senior Vice President, Head of Global Litigation GSK (Philadelphia, PA)

Julie Park Partner Morrison & Foerster LLP (San Diego, CA)

Celeste Warren Vice President, Global Diversity & Inclusion Center of Excellence, Chief Diversity & Inclusion Officer Merck

COMMENT-DOTS “...for almost 20 years. I try not to miss [this event] because I find it is a valuable way to learn about developments in the products field. Of course, it is also always great to catch up with in-house peers, outside counsel and to also meet new colleagues.”

SVP, General Counsel and Secretary, Legal and Corporate Affairs, Daiichi Sankyo, Inc. #DrugandMed twitter: @ACI_Pharma linkedin: ACI: Drug and Medical Device Litigation

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C5 GROUP’S VIRTUAL EVENTS

Re-imagining the way we deliver conferences Collaboration is more vital than ever and for that, you can still rely on ACI to bring the industry together but in a different way.

We are transforming quickly to ensure you can now connect virtually and continue to gain unparalleled access to market leading intelligence and a global exchange of expertise.

Our new virtual events continue to be guided by our unifying philosophy: we believe that growth and success occurs when the power of people and the power of information come together. We may not be able to gather in person, but nothing stops connection and innovation.

What you can expect at a virtual conference Our virtual conferences are the same conferences you have come to expect in person but transformed to a virtual format. The new virtual conference delivers the same access to a community of industry leaders we have spent decades building and nurturing. We invite you to be part of this community.

Immerse yourself in live presentations, panel discussions, specialized breakout sessions and networking opportunities.

Engage in meaningful dialogue with attendees and speakers in an interactive format.

Meet 1-on-1 with attendees you select and exchange contact information for lasting connections and true engagement.

Expand your network to a global audience.

Visit solution providers and learn about the latest technologies, services and products.

PIGGY-BANK

Eliminate the costs and stress of travel.

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Reduce waste and carbon footprint through this environmentally friendly platform.

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Schedule of Events December 7

December 8

December 9

PRE-CONFERENCE WORKSHOP

MAIN CONFERENCE DAY 1

MAIN CONFERENCE DAY 2

The “5 Cs” of Successful In-House Counsel – Law Firm Partner Relationships

ACI’s Drug & Med Celebrates 25 Years

MDL Case Study

Covid-19 Impact on Drug & Medical Device Litigation

Impact of Current Events on Juror Mindsets and Verdicts

Virtual Trial Practice Tool-Kit

Diversity & Inclusion Town Hall

Keynote Address, Robert Charrow, HHS Changes to FDA Approval Processes

BREAKOUT SESSIONS:

A View From the Bench Data Analytics in MDL Management New Technologies, Digital Health and Artificial Intelligence Interactive Ethics Lab

Procedural Defense Developments Crisis Management Boot Camp State of the Union on Preemption Product Recall Dos and Don’t’s

#DrugandMed twitter: @ACI_Pharma linkedin: ACI: Drug and Medical Device Litigation

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Monday, December 7 (EST) PRE-CONFERENCE WORKSHOP 9:00 – 12:30

Think Tank on the “5 Cs” of Successful In-House Counsel – Law Firm Partner Relationships: Cost, Competency, Communication, Collaboration and Culture MICROPHONE Charna Gerstenhaber, Vice President, Head of Litigation & Investigations, Novartis Pharmaceuticals (East Hanover, NJ)

Veronica M. Lei, Assistant General Counsel – Litigation and Legal Compliance, Eli Lilly and Company (Indianapolis, IL)

Richard W. Silbert, VP, Chief Legal Strategist, Purdue Pharma L.P. (Stamford, CT)

Julie M. Lewis, General Counsel & Corporate Secretary, Carestream Health (Rochester, NY)

Patricia A. Barbieri, SVP, General Counsel and Secretary, Legal and Corporate Affairs, Daiichi Sankyo (Basking Ridge, NJ)

MODERATOR:

Kristen Renee Fournier, Partner, King & Spalding LLP (New York, NY)

Join us for a unique conversation with our in-house counsel faculty designed to shed light on the expectations of in-house counsel from their law firm partners with regard to things like cost control and budgeting, demonstrating competency, value and efficiency, effective and succinct communication, meaningful collaboration and aligning cultures. This workshop will also serve as a vehicle for other in-house counsel to benchmark their current “5C’s” strategies with the workshop presenters.

COST • Monitoring legal spend, balancing the budget and establishing best practices for cost reduction • Engaging in budgeting discussions that establish transparency early on and enhance predictability for cash flow purposes

• Identifying processes and electronic systems to assist with budgeting, fee arrangements, billing and matter management • Implementing creative pricing solutions and tactics such as alternative fee arrangements, fixed-fee retainer agreements and stratified staffing models

COMPETENCY • Considerations in selecting outside counsel and strategies for finding the right talent • Evaluating the appropriateness of work product

• Reconciling firm capabilities versus individual attorney reputation and ability • Understanding the importance of relaying business acumen as well as legal expertise

COMMUNICATION • Communicating value and collaboration between corporate legal and outside counsel • Establishing the desired level of commitment, availability and responsiveness early-on in the relationship

• Succinctly focusing on shared, pragmatic business goals • Determining preferences for formality of correspondence and practical versus academic guidance

COLLABORATION • Embracing a holistic representation style: engaging market leading law firms and well respected outside vendors to join forces and collaborate for the benefit of the company • Enhancing collaboration amongst lawyers within the organization to maximize efficiency

• Emphasizing the capabilities and skill sets of individual lawyers or groups to help create new ideas for client offerings • Learning your client-company’s business and using internal counsel input as a resource

CULTURE • Taking opportunities to foster interaction, align culture and build trust between the firm and client • Identifying what is important to those with whom you are working and finding meaningful connections

• Finding opportunities to collaborate on industry, political, social or charitable endeavors

#DrugandMed twitter: @ACI_Pharma linkedin: ACI: Drug and Medical Device Litigation

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Tuesday, December 8 (EST) MAIN CONFERENCE DAY 1 8:45

Co-Chairs’ Opening Remarks

MICROPHONE Christopher Guth, Senior Assistant General Counsel, Bayer (Pittsburgh, PA)

MICROPHONE Charna Gerstenhaber, Vice President, Head of Litigation & Investigations, Novartis Pharmaceuticals (East Hanover, NJ

9:00

ACI’s Drug & Med Celebrates 25 Years: Industry Leaders Take a Look Back and a Look Ahead MODERATOR:

MICROPHONE Mary-Alice Barrett, Associate General Counsel, Genentech (Little Falls, NJ)

Lori Cohen, Co-Chair, Global Litigation, Chair, Pharmaceutical, Medical Device & Health Care Litigation Group, Chair, Trial Practice Group, Greenberg Traurig LLP (Atlanta, GA)

Max Heerman, Senior Legal Counsel, Litigation, Medtronic (Washington, DC) Michael Imbroscio, Partner, Co-Chair of the Products Liability & Mass Tort Practice, Covington & Burling LLP (Washington, DC) Jean F. Holloway, Senior Vice President, General Counsel, Chief Compliance Officer and Corporate Secretary, CryoLife, Inc. (Kennesaw, Georgia)

10:00 NETWORKING BREAK

1:1 and Smaller-Group Networking

As ACI’s Drug & Medical Device Litigation conference celebrates its 25th year, our esteemed in-house counsel and law firm panelists will engage in an interactive discussion of the most significant legal and business developments that have impacted drug and device litigation in the last quarter century, as well as their implications and influence on future decisions, trends and strategies in this arena.

Exhibit Hall Meet-Ups

Virtual Speaker Meet and Greets

COVID-19 IMPACT ON DRUG & MEDICAL DEVICE LITIGATION 10:30

Analyzing the Implications of PREP Act Immunity on Future Drug and Device Litigation and Assessing Potential Covid-19 Related MDLs

MICROPHONE Brennan Torregrossa, Senior Vice President, Head of Global Litigation, GSK (Philadelphia, PA)

Erin Bosman, Co-Chair of Class Action and Mass Torts, Morrison & Foerster LLP (San Diego, CA)

• Examining the impact of Covid-19 on existing and future litigation • PREP Act immunity: how is it being interpreted and applied in cases related to Covid-19 treatments, diagnostics, PPE, ventilators, vaccines, etc.? » Interpreting what qualifies as “covered countermeasures” » What are the key limitations/qualifications on immunity protection » Will “off-label” uses qualify for immunity absent an express exemption?

John P. Lavelle, Jr., Partner, Morgan, Lewis & Bockius LLP (Philadelphia, PA)

• How should clients be counseled in the face of much grey area and uncertainty around this?

• What types of drug and device product liability claims stemming from Covid-19 are likely to turn into MDLs? » Assessing whether the particular subject matter will be ripe for an MDL • Identifying specific considerations for PPE product liability claims

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11:30

Embracing the New Normal: Establishing Best Practices for Efficient and Successful Virtual/Remote Trial Practice

MICROPHONE Wendy West Feinstein, Partner, Morgan, Lewis & Bockius LLP (Pittsburgh, PA)

Adam Spicer, Partner, King & Spalding LLP (Atlanta, GA)

Paul LaFata, Partner, Dechert LLP (New York, NY)

Due to this year’s pandemic, many attorneys and courts have had to quickly embrace a “new normal” which relies largely on virtual and remote trial practice. As we all become more comfortable with virtual proceedings and procedures, we may likely see a more permanent shift in this direction in the longer term. This panel will share strategies that can be employed to conduct successful and efficient virtual or remote trial practice going forward. Tune in as the panelists address: • How has Covid-19 affected drug and medical device litigation practice from a practical standpoint?

• How are we likely to refocus how we’re approaching trial practice in the longer term?

• Strategies and best practices for: » Remote discovery

12:30

LUNCH BREAK

» Preparing witnesses remotely » Engaging in virtual depositions, mediations, oral arguments, etc.

• Identifying the biggest challenges to virtual trial practice and tools for overcoming them • Assessing whether the value of seeing someone in person is outweighed by the economic savings of not traveling and doing things virtually/remotely

Presentation & Networking Hosted by: Exhibit Hall Meet-ups

1:30

Keynote Address Robert P. Charrow General Counsel US Department of Health & Human Services (Washington, DC) 2:00

Analyzing Recent Changes to FDA Approval Processes and Future Implications on Product Liability Cases

MICROPHONE Sheea Sybblis, Associate General Counsel, Nestle Health Science (New York, NY)

Ashley Garry, Senior Legal Counsel, ArTara Therapeutics (Indianapolis, IN)

In connection with the Covid-19 pandemic, there have been certain changes to the processes for securing FDA approval of virus relates therapeutics, testing and preventative materials that have needed to get to market in a more expedited fashion. This panel will provide a clear understanding of:

• Understanding what you can and cannot do in terms of marketing a product governed by an EUA

• The ways the government has altered FDA review and approval processes this year in order for certain products to get to market

• Assessing the different guidances issued by the FDA exercising its discretion to suspend certain enforcement actions with respect to certain product categories

• The FDA’s use of “Emergency Use Authorizations” (EUAs) in connection with bringing certain products to market » What does the EUA process entail?

» Specific considerations and pitfalls to avoid when marketing a product that is FDA approved for one particular use and EUA approved for a new/different use

• How will the last year’s events impact the FDA in the next year and their priorities and initiatives moving forward?

• What implications may this have on future product liability litigation?

» What findings does the FDA have to make before making such an emergency declaration

2:45 NETWORKING BREAK

1:1 and Smaller-Group Networking

Exhibit Hall Meet-Ups

#DrugandMed twitter: @ACI_Pharma linkedin: ACI: Drug and Medical Device Litigation

Virtual Speaker Meet and Greets

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BREAKOUT SESSIONS Track A The Practice of Drug and Medical Device Litigation: Strategies for Combatting the Complexities of Today’s Products Liability Landscape

Track B The Business of Drug and Medical Device Litigation: Understanding the True Costs of the New Products Liability Environment

3:15

3:15

Applying the Latest Procedural Defense Developments to Your Litigation Strategy: Recent Updates in Personal Jurisdiction, Snap Removals and Forum Non Conveniens

Strengthening Your Future Crisis Management Capabilities: Lessons Learned from Covid-19 on Combatting Business Disruption and Enhancing Your Crisis Management Response

MICROPHONE

Sarah Padgitt, Associate General Counsel, Baxter (Deerfield, IL)

MICROPHONE Amy Todd Klug, Associate General Counsel, Litigation & Corporate Operations, Legal

John Galvin, Partner, Thompson Coburn LLP (St. Louis, Missouri)

James (Jim) Beck, Senior Life Sciences Policy Analyst, Reed Smith LLP

• Analyzing the latest developments in personal jurisdiction rulings and defenses and incorporating them into your trial practice • Assessing recent decisions and developments addressing the procedural steps necessary to complete snap removals • Identifying and applying the latest strategies for forum non conveniens arguments 4:15

State of the Union on Preemption: Examining the Continued Aftermath of Albrecht and the Latest Developments in Medical Device Preemption Efforts

MICROPHONE

Michelle M. Bufano, Partner, Patterson Belknap Webb and Tyler LLP (New York, NY)

Marcela Kirberger, General Counsel, Corporate Secretary and Chief Compliance Officer Roche Diagnostics Corporation (Indianapolis, IN)

Alan E. Rothman, Counsel, Sidley Austin LLP New York, NY)

• Examining the latest preemption rulings and emerging theories and defenses • Assessing the current status of Albrecht and how it has been being interpreted and applied by the lower courts » What successes have the plaintiffs’ bar been seeing in avoiding the preemption defense? » Which defense arguments work and which don’t? » Examining the latest 510(k) preemption efforts and strategies for navigating preemption motions for PMA devices

5:15 Conference Adjourns

SHARE-ALT Virtual Networking Hour Sponsored by

Affairs, Daiichi Sankyo, Inc. (Basking Ridge, NJ)

Adam Bassing, Associate General Counsel, U.S. Litigation & Global Safety, UCB, Inc. (Smyrna, GA)

Julie Park, Partner, Morrison & Foerster LLP (San Diego, CA)

The COVID-19 pandemic has caused life sciences companies to adapt to supply chain, R&D and clinical development disruptions and financial challenges that would have previously been unfathomable. The challenges involved in such a crisis often require a comprehensive view of multiple disciplines to develop effective solutions. This panel will discuss how an organization can most effectively focus its response to a crisis while minimizing business disruption. Topics to be discussed are: • Strengthening your crisis response and management capabilities • Managing challenges related to supply chain and manufacturing • Responding to road bumps in research and development 4:15

• • • •

Workforce strategies Financial and downturn planning Financial reporting and tax issues Best practices for dealing with media and court of public opinion

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Product Recall Dos and Don’ts: Identifying Best Practices for Effectively Managing a Product Recall

MICROPHONE Mollie Benedict, Partner, Tucker Ellis LLP

Howard M. Cyr, Assistant General Counsel, Teleflex (Wayne, PA)

Rachel Gallagher, Director, Legal Counsel, Teva Pharmaceuticals (Horsham, PA)

• Identifying best practices for coordinating your team and minimizing damage to your company in the face of a nationwide product recall • Tips for identifying early warning signs and getting out in front of a recall early • Key actions to consider when conducting a product recall and how to execute them carefully and thoroughly • Understanding the different roles of in-house counsel, outside counsel, company witnesses, investigators, etc; and how everyone should work together to manage the recall and its effects • Best practices for » Conducting a health-hazard assessment » Getting the word out/ crafting your recall communication » Planning your course of action » Talking to third-party vendors » Contacting the FDA

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Wednesday, December 9 (EST) MAIN CONFERENCE DAY 2 8:45

Opening Remarks and Recap of Day One 9:00

MDL Case Study: Analyzing the Unique Nuances of Three of 2020’s Most Significant MDLs

MICROPHONE

Matthew A. Campbell, Partner, Co-Chair, Product Liability & Mass Torts Practice, Winston & Strawn LLP (Washington, DC)

Sara Thompson, Partner, Greenberg Traurig LLP (Atlanta, GA)

This panel will examine three MDLs that the pharmaceutical and medical device industries have been very closely watching – Hernia Mesh (In Re: Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Products Liability Litigation – MDL No. 2846), Valsartan (Valsartan MDL No. 2875) and Zantac (In Re: Zantac (Ranitidine) Products Liability Litigation – MDL No. 2924). The panelists will compare and contrast the unique elements of these MDLs, and provide insights on:

10:00 NETWORKING BREAK

1:1 and Smaller-Group Networking

Mara Cusker Gonazalez, Partner, Dechert LLP (New York, NY)

Marilyn Moberg, Partner, Reed Smith LLP (Los Angeles, CA)

• Each of their distinctive elements and litigation challenges • Successful plaintiff tactics and defense strategies • Notable judicial rulings and key takeaways • Nuances with MDLs involving Rx versus OTC drugs

Exhibit Hall Meet-Ups

Virtual Speaker Meet and Greets

10:30

Assessing How Recent Current Events are Impacting Juror Mindsets, Perceptions and Verdicts in Drug and Device Cases

MICROPHONE

Matthew L. Stennes, Vice President, Chief Litigation & Investigations Counsel, Medtronic (Minneapolis, MN)

Buffy Mims, Partner, Shook Hardy & Bacon LLP (Washington, DC)

• Examining how events from this year, such as the pandemic and the recent presidential election, will affect juror mindsets in drug and medical device litigation going forward • Are jurors viewing big pharma and device companies more favorably since Covid-19?

• Will juries have as big of an appetite to award big damages in the post-Covid 19 recession era?

Rick Fuentes, Ph.D., Founding Partner, R&D Strategic Solutions (Atlanta, GA)

• Will jurors have more understanding of things like science, epidemiology and causation after watching these things play out each day in the news over the last year? If so, how do we approach dealing with “smarter” juries?

• Strategies for how to shape your statements and narratives to the jury in light of possible new juror perceptions of big pharma and device companies

#DrugandMed twitter: @ACI_Pharma linkedin: ACI: Drug and Medical Device Litigation

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11:15

A View From the Bench – 2020 Edition: Judicial Insights on How this Year’s Events Have Impacted Dockets, Court Functions, Judicial Proceedings and the JPML in General

MICROPHONE

Honorable Karen K. Caldwell, Chief Judge, U.S. District Court, E.D. Kentucky Panel Judge, Judicial Panel on Multidistrict Litigation (JPML)

Honorable John R. Tunheim, Chief Judge, U.S. District Court, D. Minnesota

Honorable F. Dennis Saylor, IV, Chief Judge, U.S. District Court, D. Massachusetts

Honorable Eduardo C. Robreno, Senior Judge, U.S. District Court, E.D. Pennsylvania

Honorable William F. Highberger, Superior Court Judge, Los Angeles County Superior Court

Honorable Rex Burlison, Circuit Judge, 22nd Judicial Circuit of MO MODERATOR:

Andrew T. (Andy) Bayman, Partner, King & Spalding LLP (Atlanta, GA)

In light of this year’s crisis, we have seen courts take measures such as temporarily suspending oral arguments, ramping up the use of virtual tools to conduct hearings, and even holding socially distanced jury trials. Hear from this panel of esteemed judges on how this year’s events have impacted their current dockets, court functions and the JPML as a whole, as well as what to expect in their courtrooms going forward. Topics to be discussed include:

• Following the suspension of speedy trial demands and cases being pushed, how are they reorganizing and reprioritizing the order of trial dates?

• How are the judges adjusting to the continued effects of this year’s pandemic on their dockets?

• Will we see more courts demanding other mechanisms to lighten the load of cases?

• What implications are being seen from courts temporarily suspending oral arguments?

• How can attorneys help judges who are experiencing an increased backlog of cases?

• Will this lead to more courts requiring mediation or early dispute resolution?

• How are the courts handling virtual hearings, trial practice and the like?

12:45

Lunch Break

1:45

Diversity & Inclusion Town Hall: An Honest Discussion About Drivers of Successful D&I Initiatives and the Latest Challenges Faced by Law Firms and Life Sciences Companies

MICROPHONE

Celeste Warren, Vice President, Global Diversity & Inclusion Center of Excellence, Chief Diversity & Inclusion Officer, Merck

Sonia Chen Arnold, General Counsel- Lilly Oncology, Eli Lilly and Company (Indianapolis, IN)

Successful diversity and inclusion initiatives are far more complex than merely generating a list of general objectives. Implementing effective D&I programs often require a dedication to building increased equity, diversity, and inclusion into your company’s DNA and operating behaviors. As many in the industry have seen however, this is not always as simple as it sounds, and many further question whether financial investments in D&I initiatives by law firms and life sciences companies may suffer as a result of this year’s economic downturn. Join this panel in a discussion of what D&I initiatives are currently working to yield lasting effects and overcoming the latest challenges companies are facing on this front. Let your voice be heard in this unique open floor session, designed to give all attendees an opportunity to add to the dialogue.

COMMENT-DOTS “I look forward to the ACI Drug and Med Conference every year as I’m sure to find helpful discussion on current topics that matter to me as well as a balanced outlook from both in-house and outside counsel.”

Senior Director, Legal Counsel #DrugandMed twitter: @ACI_Pharma linkedin: ACI: Drug and Medical Device Litigation

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2:45

Understanding the Use of Data Analytics in the Management of MDLs

MICROPHONE Christopher Guth, Senior Assistant General Counsel, Bayer (Pittsburgh, PA)

Megan Pizor, General Counsel, Litigation Management, Inc. (Mayfield Heights, OH)

Embracing an idea floated by the defense bar, judges in at least three recent prominent MDLs have ordered lawyers to prescreen some of the lawsuits through an “initial census” process.

The use of initial census forms as an early vetting process to weed out meritless lawsuits will seemingly become more and more common, however there are now many questions about how the information is being collected and used, and how this will impact MDLs moving forward. This panel will discuss topics including:

Gabriel Egli, Partner, Shook Hardy & Bacon LLP (St. Louis, MO)

• How the data and analytics from these forms are being used in the management of MDLs • How the data is impacting judicial decisions and future proceedings • Who has access to the data?

• How is the information collected and protected?

• How are the costs of this allocated amongst the parties involved?

• How will this impact MDLs moving forward?

3:45 NETWORKING BREAK

1:1 and Smaller-Group Networking

Exhibit Hall Meet-Ups

Virtual Speaker Meet and Greets

4:15

Analyzing Risks and Liabilities Associated with New Technologies, Digital Health and Artificial Intelligence

MICROPHONE Carly W. Stephani, Principal Litigation Counsel, Litigation & Global Investigations,

Paul J. (PJ) Cosgrove, Partner, Ulmer & Berne LLP (Cincinnati, OH)

Digital health technologies, including tools incorporating AI, are offering profound benefits to the life sciences industry and opportunities to improve patient care. However, they also carry the inescapable burden of new mistakes and liability risks. This panel will shed light on the full spectrum of implications of these new technologies and how counsel can manage these changes to minimize future product liability.

• Assessing the ways in which AI is becoming an important part of drug development and marketing strategies, disease diagnosis processes, and beyond

Medtronic (Minneapolis, MN)

4:45

• Understanding the various new liability risks introduced by new digital health and AI advances • Examining how drug and medical device product liability counsel can prepare to minimize future liabilities associated with these new technologies

check-square LIVE POLLING

Interactive Ethics Lab Test your ethical skills with a series of anonymous polling questions on sensitive, complex hypothetical scenarios. Discover how your approach to tackling ethical dilemmas in drug and medical device litigation compares to your peers, and benefit from a practical discussion of the polling results and important takeaways for your practice.

5:45

Conference Ends

#DrugandMed twitter: @ACI_Pharma linkedin: ACI: Drug and Medical Device Litigation

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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 New York State Continuing Legal Education Board.

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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.

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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.

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Thank You to Our Sponsors & Partner The Sponsor and Exhibitors below will be offering solutions, products, insights and expertise to help you improve your business outcomes and goals. You’ll see most during the event in their expo booth, as part of the scheduled content, and during our planned networking events.

LEAD SPONSORS Greenberg Traurig, LLP is an international law firm with more than 2,200 attorneys in 40 locations in the United States, Latin America, Europe, Asia, and the Middle East, and is consistently among the largest firms in the U.S. on the Law 360 400 and among the Top 20 on the Am Law Global 100.

GT’s Pharmaceutical, Medical Device & Health Care Litigation Practice regularly serves as national, regional, special trial, or science counsel – in both mass torts and individual cases – to leading life sciences companies that produce innovative, lifesaving products.

An integral part of the firm’s 600+ attorney Global Litigation Practice, this group of attorneys was recognized as The American Lawyer’s 2018 “Product Liability Litigation Department of the Year.” www.gtlaw.com

King & Spalding is an international law firm with more than 1,000 lawyers in 20 offices globally. Our Pharmaceutical & Medical Device Litigation Team helps manufacturers navigate the litigation life cycle, from risk assessments through trial and appeal. Working with more than 300 lawyers and professionals who devote all or a substantial portion of their practices to life-sciences clients, we know the industry and governing laws better than anyone. With over 175 lawyers across the world, our Product Liability team, which Law360 named in 2018 as Practice Group of the Year for the sixth consecutive year, leverages knowledge of the complex science and technology behind today’s products to deliver litigation victories.

We handle the most significant individual, multidistrict, mass tort and class action lawsuits for pharmaceutical and medical device companies. We offer our clients a depth of trial experience that is increasingly unusual in firms of our size. While many firms can “litigate” cases, we try product cases each year in some of the most challenging jurisdictions for corporate clients. For more information, please visit www.kslaw.com.

SUPPORTING SPONSORS Dechert is a global specialist law firm. Focused on sectors with the greatest complexities, legal intricacies and highest regulatory demands, we excel in delivering practical commercial judgment and deep legal expertise for our client’s most crucial matters. Our work is widely recognized, with 32 standout practices noted by Chambers Global, including global-wide rankings for corporate investigations and anti-corruption. In an increasingly challenging environment, clients look to us to serve them in ways that are faster, sharper and leaner without compromising excellence.

Dechert’s corporate investigations, white collar crime and compliance team includes former federal prosecutors as well as former government regulators and compliance officers with deep experience in both preventing and resolving anti-corruption compliance issues. With companies facing unprecedented scrutiny of their business conduct, Dechert has the global team and resources to help clients find answers to difficult questions and creative solutions to high-stakes problems. For more information, visit www.dechert.com

Plan in advance which brands you might want to connect with to gain even more insights from the conference.

Morrison & Foerster was founded in San Francisco in 1883. Today, with approximately 1,000 lawyers in 17 offices across the U.S., Asia and Europe, Morrison & Foerster offers clients a comprehensive platform of global legal services, including extensive capabilities in the areas of corporate finance, mergers and acquisitions, tax, regulatory & compliance, litigation, and, project finance, among many others. Our name is synonymous with a commitment to client service that informs everything that we do. We are recognized throughout the world as a leader in providing cutting-edge legal advice on matters that are redefining practices and industries. www.mofo.com Morgan Lewis is a global law firm with more than 2,200 legal professionals in 31 offices worldwide. With more than 250 international partners and counsel who focus on the life sciences industry, Morgan Lewis has one of the most comprehensive practices in this area. We are unsurpassed in our global understanding of the business, regulatory, intellectual property, litigation, and related issues that our clients face along the product life cycle, from innovation and emerging business issues, through research and development, regulatory approval, product reimbursement, marketing and distribution, to fraud and abuse, product liability and intellectual property litigation, to mergers and acquisitions, collaborations, and outsourcing. Morgan Lewis offers extensive capabilities and decades of experience coordinating complex national litigation, in addition to providing efficient, powerful solutions for the increasingly demanding discovery environment. We are nationally recognized for our leadership and innovation in developing alternative fee structures.

For more information, please visit www.morganlewis.com.

Reed Smith’s life sciences team is committed to anticipating and solving legal challenges so you can focus on what you do best: improving and saving lives.

In addition to our skilled life sciences transactional and regulatory lawyers, our highly-regarded, fullservice life sciences litigation practice features a deep bench of seasoned trial lawyers and appellate specialists. For more than 40 years, Reed Smith has served as national, strategic, trial, and science counsel to the top global pharmaceutical and medical device manufacturers in single plaintiff and complex litigation matters, and is regularly recognized for its successes in high-profile product liability and mass tort litigations.

With a well-earned reputation as a litigation powerhouse, Shook, Hardy & Bacon is the go-to firm for the world’s leading health, science and technology companies. In addition to fielding the largest product liability practice in the world, Shook handles commercial litigation, environmental and toxic tort, and intellectual property disputes for the pharmaceutical and medical device, food and beverage, and consumer goods industries. While its high-stakes, complex litigation expertise is second to none, the firm also has the regulatory compliance and risk management experience upon which companies have come to rely. Established in Kansas City in 1889, Shook has grown to approximately 500 attorneys and 200 research analysts and paraprofessionals, many of whom have advanced scientific and technical degrees. Shook’s offices are strategically located in Atlanta, Chicago, Denver, Houston, Kansas City, London, Los Angeles, Miami, Orange County, Philadelphia, San Francisco, Seattle, Tampa and Washington, DC. www.shb.com

ASSOCIATE SPONSORS Litigation Management, Inc. (LMI) is a legal and medical data analytics company providing strategic discovery, document management, analytics and custom hosted technology solutions to better manage mass tort and product liability litigation. LMI services are designed to utilize the right combination of people, processes and technology to increase efficiencies and reduce costs. Our 35+ years of experience allows us to guide you efficiently and effectively from early vetting to successful matter resolution. www.lmiweb.com Patterson Belknap Webb & Tyler LLP is based in New York City with approximately 200 lawyers delivering a full range of services across more than 20 practice groups in both litigation and commercial law. More than half of the attorneys at Patterson Belknap are devoted to litigation. Our litigating partners have tried hundreds of cases, including many of the most complex in their fields. We frequently serve as national and regional litigation counsel for the nation’s largest pharmaceutical and medical device companies in products liability matters. www.pbwt.com Thompson Coburn is a full-service law firm with more than 375 attorneys practicing in more than 50 areas of the law, with offices in Chicago, Dallas, Los Angeles, Southern Illinois, St. Louis and Washington, D.C. In 2019, the Firm was recognized by the Association of Corporate Counsel as an ACC Value Champion, an international honor that recognizes “best-in-class” innovations that drive value and dramatically improve efficiencies within corporate law departments.

Thompson Coburn also received the Minority Corporate Counsel Association’s 2019 George B. Vashon Innovator Award, a recognition for organizations that have made extraordinary strides to support diverse attorneys.

At Ulmer, the focus is on exceeding client expectations and delivering superior, customized legal solutions for an exceptional value. The firm is a leader in defending class-action, multidistrict, and mass tort litigation concerning drugs, biologics, medical devices, and dietary supplements. Ulmer attorneys have served as lead national defense counsel in high-impact litigation involving antidepressants, contraceptives, testosterone replacement therapy, pain medications, oncology drugs, gastrointestinal products, ADHD medications, pelvic mesh products, glucose monitoring products, weight management products, and performance training supplements. They also counsel pharmaceutical, medical device, and dietary supplement companies on regulatory and risk management matters. The practice is strengthened by its many attorneys with degrees in various scientific disciplines. Learn more at Ulmer.com.

Winston & Strawn LLP is an international law firm with 1,000 attorneys among 16 offices in North America, Europe, and Asia. With approximately 130 attorneys, Winston’s patent litigation practice is one of the most active and highly regarded in the country. Most recently, Winston was recognized for its excellence in IP litigation (United States – Tier 1) by Benchmark Litigation. In 2018, our IP litigation practice was once again ranked in the first tier nationally

by US News & World Report in its Best Law Firms survey, and both Chambers USA and Legal 500 selected our IP practice for national rankings. The firm also was recently ranked as one of the country’s best in the IAM Patent 1000 survey, which commented that “the life sciences industry is, famously, a bastion of strength for the firm.” Winston has long been a leading player in pharmaceutical patent litigation, representing such clients as Abbott, Pfizer/Hospira, Teva, Sun Pharmaceutical, and Watson Pharmaceuticals. Over the years, Winston has litigated some of the largest pharmaceutical cases in history, including pivotal Hatch-Waxman cases involving dozens of leading pharmaceuticals with combined annual sales easily exceeding $25 billion. For more information, visit www.winston.com.

MEDIA PARTNERS

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Virtual Sponsorship Opportunities We are thrilled to share our new completely web-based virtual platform that recreates our live conferences in an online, virtual setting and puts your brand directly in front of potential new clients.

With this new platform, you can put your company front and center with prominent placement of sponsor logos, exclusive networking events and one-to-one meeting opportunities. Our programs are designed with built-in networking times, devoted expo hours, and the ability to connect via chat or face-to-face with key attendees.

The sponsor lounge/expo floor, much like a live conference, gives attendees the ability to choose which booth they would like to enter from the list of service providers at the conference. The sponsor lounge will be open before, during and after the conference.

Here’s what you can expect:

Engage in an interactive format that encourages dialogue among attendees, speakers, sponsors, and exhibitors Host your own booth in the Virtual Expo Hall and captivate your audience with an interactive multimedia content platform

CLICK TO PLAY VIEW VIDEO

Showcase your latest technologies, services and products with a promotional video, presentation, link to your website, or live demonstration Meet 1-on-1 with attendees and exchange contact information for lasting connections and true engagement

Don’t miss the opportunity to maximize participation or showcase your organizations services and talent. For more information please contact us at: SponsorInfo@AmericanConference.com With conferences in the United States, Europe, Asia Pacific, and Latin America, the C5 Group of Companies: American Conference Institute, Canadian Institute, & C5 Group provides a diverse portfolio of conferences, events and roundtables devoted to providing business intelligence to senior decision makers responding to challenges around the world.

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