ACI's Premier Conference on Life Sciences Antitrust - DS by C5Group

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ACI’S PREMIERE CONFERENCE ON

Life Sciences Antitrust Calendar-alt September 30, 2021 (EDT) Virtual Conference

Benefit from the Insights of Our Distinguished Conference Co-Chairs: Ian R. Conner Partner Latham & Watkins LLP (Former Director of the FTC’s Bureau of Competition, 2019-2021) Debbie Feinstein Partner Arnold & Porter Kaye Scholer LLP (Former Director of the FTC’s Bureau of Competition, 2013-2017)

CONFERENCE SPONSOR:

Leading antitrust counsel will participate in discussions and provide analysis on: ĉ Current FTC and European Competition Authority Priorities in Life Sciences Antitrust Enforcement

ĉ The Latest Legislation and Competition Policy Being Contemplated by the Biden Administration

ĉ What the Global Life Sciences Industry Needs to Know About The “Multilateral Pharmaceutical Merger Task Force”

ĉ Recent Criminal Generic Price Fixing Cases and How They May Change the Outlook for Competition in the Industry

ĉ Future Forecasts for Reverse-Payment Settlement Litigation, Patent Thicketing, and Restrictive Distribution Agreements

ĉ The Implications of Recent Court Decisions and Enforcement Activity Related to Product Hopping, Sham Petitioning, Product Bundling, and Loyalty Rebating SUPPORTING SPONSORS:

AmericanConference.com/Life-Sciences-Antitrust • 888 224 2480

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

* Pay-for-Delay Lawsuits * Price Fixing Investigations * * M&A Scrutiny in the U.S. and Abroad * * New Antitrust Enforcement Policies * Now more than ever, life sciences companies must remain abreast of emerging enforcement trends as well as the government’s antitrust analysis for evaluating anticompetitive behavior. As we proceed through 2021, the spotlight on antitrust activity in the life sciences industry shines brighter than ever. For several years, state and federal antitrust enforcers in the U.S. and even international antitrust and competition authorities have been watching the life sciences industry closely for anticompetitive activity. The Biden Administration is now forming its new competition policy and there is pending antitrust legislation which will unquestionably affect the life sciences industries. At the same time, the U.S. DOJ has just confirmed that they are developing new policies to prevent patents from being used as tools for anticompetitive practices, a recent series of criminal antitrust investigations have been brought by federal and state authorities alleging generic price fixing collusion, and a novel multinational task force has just been put in place to examine the anticompetitive impact of life sciences M+A activity. All of these new changes are raising life sciences antitrust concerns to an all-time high, and could significantly increase the volume of litigation for IP and antitrust trial lawyers and their clients. That is why you do not want to miss the chance to attend the only event on the market where you can hear from antitrust enforcers, leading in-house counsel, and law firm attorneys on how to successfully tackle the most complex antitrust challenges currently facing biopharmaceutical manufacturers today.

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.

VIRTUAL NETWORKING OPPORTUNITIES Take advantage of 1:1 speed networking, exhibit hall meetups and direct video chats with fellow conference participants. Your next legal team, business partner, or client could be right in one of our virtual networking rooms – it is up to you to find them!

Learn more about our virtual platform here

2 | #LifeSciencesAntitrust twitter: @ACI_Pharma

linkedin: ACI: Pharmaceuticals / Biotech / Medical Device – Legal, Regulatory, IP and Compliance Professionals

Distinguished Faculty CO-CHAIRS Ian R. Conner Partner Latham & Watkins LLP

Debbie Feinstein Partner Arnold & Porter Kaye Scholer LLP

SPEAKERS Takanori Abe Managing Partner ABE & Partners Jeffrey C. Bank Partner, Antitrust and Competition Wilson Sonsini Goodrich & Rosati Ian R. Conner Partner Latham & Watkins LLP Lisl Dunlop Partner Axinn Veltrop & Harkrider LLP Debbie Feinstein Partner Arnold & Porter Kaye Scholer LLP

Renata B. Hesse Partner, Co-Head of Antitrust Group Sullivan & Cromwell LLP Kenneth Reinker Partner Cleary Gottlieb Steen & Hamilton LLP Jeny Maier Partner Axinn Veltrop & Harkrider LLP Jeffrey (Jeff) D. Martino Partner Baker & McKenzie LLP Michael Moiseyev Partner Weil Gotshal & Manges LLP

Taylor M. Owings Partner, Antitrust and Competition Practice Group Baker Botts LLP Seth Silber Partner, Antitrust and Consumer Protection Wilson Sonsini Goodrich & Rosati Katie Nolan Stevaux Assistant General Counsel, Litigation Genentech Eric Stock Partner Gibson, Dunn & Crutcher LLP

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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.

AmericanConference.com/Life-Sciences-Antitrust • 888 224 2480

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

CONFERENCE AGENDA Thursday, September 30, 2021 (EDT) 10:00 AM

11:15 AM Morning Break

Co-Chairs’ Opening Remarks Ian R. Conner Partner Latham & Watkins LLP (Former Director of the FTC’s Bureau of Competition, 2019-2021) Debbie Feinstein Partner Arnold & Porter Kaye Scholer LLP (Former Director of the FTC’s Bureau of Competition, 2013-2017) 10:15 AM

The Trajectory of A Perfect Antitrust Storm: Examining What the Convergence of Interests in Competition Policy and Law in the New Administration Means for the Life Sciences Industry Ian R. Conner Partner Latham & Watkins LLP (Former Director of the FTC’s Bureau of Competition, 2019-2021) Kenneth Reinker Partner Cleary Gottlieb Steen & Hamilton LLP

11:45 PM

The End of the Mega Deal?: What the Global Life Sciences Industry Needs to Know About The Multilateral Pharmaceutical Merger Task Force and the Future of M&A Internationally Michael Moiseyev Partner Weil Gotshal & Manges LLP (Former Assistant Director of FTC’s Bureau of Competition, Mergers I Division, 2003-2020) Debbie Feinstein Partner Arnold & Porter Kaye Scholer LLP (Former Director of the FTC’s Bureau of Competition, 2013-2017) Lisl Dunlop Partner Axinn Veltrop & Harkrider LLP • Exploring the latest activity of the “Multilateral Pharmaceutical Merger Task Force” » What is the cross-border pharma Task Force doing to review and update the approaches employed by antitrust and competition agencies when analyzing pharmaceutical mergers? » What theories of potential harm are they identifying with pharmaceutical M+A activity?

Jeny Maier Partner Axinn Veltrop & Harkrider LLP

» How are deal reviews likely to become more challenging in the future? » How may new review processes be operationalized and what will this mean for the industry?

• Examining the latest developments in legislation and competition policy being contemplated by the Biden administration in the realm of pharma antitrust • How has the FTC adjusted its enforcement priorities or modified its competitive analysis of pharmaceutical sector conduct due to changes in the economy or political leadership over the past year? • What recent efforts are being made to create new laws to prohibit anticompetitive conduct? What is Congress looking at most closely in this area? • What changes are we seeing / expected to see with regard to antitrust enforcement under the new administration? • Assessing the impact of the recent Supreme Court decision stripping the FTC of authority to seek monetary relief in federal court in antitrust cases » Exploring the potential for congressional action and alternative avenues the FTC may pursue, as well as the potential for other enforcers to take action

• Examining how the FTC, DOJ, European Commission, UK Competition and Markets Authority and China’s competition authorities are all looking at: » Reviews of mergers and acquisitions involving nascent / earlystage competitors? » Evaluations of vertical mergers • Examining the FTC’s recent challenge to Illumina’s vertical merger with Grail » The future use of divestiture as an effective remedy for anticompetitive mergers • How may recent findings of the European Commission impact global pharmaceutical operations moving forward? • Best practices for moving forward amidst escalating antitrust scrutiny of pharma M+A 1:00 PM

1:1 Networking

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4 | #LifeSciencesAntitrust twitter: @ACI_Pharma

linkedin: ACI: Pharmaceuticals / Biotech / Medical Device – Legal, Regulatory, IP and Compliance Professionals

1:15 PM Lunch Break

» What future challenges to the statute are anticipated? » What other states are looking at similar legislation?

2:15 PM

A Deep Dive Into Recent Criminal Generic Price Fixing Cases And How They May Change the Outlook for Competition in the Industry Renata B. Hesse Partner, Co-Head of Antitrust Group Sullivan & Cromwell LLP (Former Deputy Assistant Attorney General, U.S. DOJ, Antitrust Division, 2012 – 2017) Jeffrey (Jeff) D. Martino Partner Baker & McKenzie LLP • Examining the latest series of lawsuits brought by state AG’s offices alleging collusion to fix prices for generic • Assessing recent actions brought by the DOJ alleging conspiracy to fix prices for generic drugs » Sandoz, March 2020

• With Pay for Delay settlements under increased scrutiny, what other avenues are pharma companies taking to protect their products, and how are the antitrust enforcers responding to those methods? • Analyzing the latest activity surrounding the use of patent thickets » Takeaways from the recent Abbvie/Humira antitrust lawsuit • Examining recent litigation over restrictive distribution agreements » FTC and NY Attorney General’s Case Against Vyera Pharmaceuticals / Martin Shkreli 4:00 PM Afternoon Break 4:15 PM

Exploring the Implications of Recent Court Decisions and Enforcement Activity Related to Product Hopping, Sham Petitioning, Product Bundling and Loyalty Rebating

» Glenmark Pharmaceuticals, June 2020

Katie Nolan Stevaux Assistant General Counsel, Litigation Genentech

» Taro U.S.A., July 2020 » Teva, August 2020

Jeffrey C. Bank Partner, Antitrust and Competition Wilson Sonsini Goodrich & Rosati

• What are the DOJ and state AGs looking at in these cases, and will these ongoing criminal antitrust investigations cause permanent changes within the industry?

Taylor M. Owings Partner, Antitrust and Competition Practice Group Baker Botts LLP (Former Senior Counsel and Chief of Staff, U.S. DOJ, Antitrust Division, 2018 to 2021)

3:00 PM

What Does the Future Hold for Reverse-Payment Settlement Litigation, Patent Thicketing and Restrictive Distribution Agreements? Eric Stock Partner Gibson, Dunn & Crutcher LLP Seth Silber Partner, Antitrust and Consumer Protection Wilson Sonsini Goodrich & Rosati Takanori Abe Managing Partner ABE & Partners

• Examining the current state of the law on product hopping » What is the current FTC stance? • An overview of bills being introduced to crack down on the practice of product hopping • What do recent court decisions addressing product hopping suggest about how future courts may rule on such cases? • Exploring the latest enforcement activity against sham petitioning

• Assessing the latest federal legislative and case law developments impacting the Pay for Delay landscape

• Taking a look at the industry practice of creating “rebate walls” or “rebate traps” in order to limit competition from rivals – what is the latest regulatory and enforcement response? How is the FTC examining and challenging this practice?

• Analyzing this year’s case law decisions impacting the treatment of nonmonetary settlements of underlying patent litigation

• Examining recent settlements and antitrust scrutiny of pharmaceutical product bundling

» How are the courts defining what constitutes a “large and unjustified” payment as set forth by FTC v Actavis? • Examining court insights regarding the admissibility of expert opinions concerning the likelihood of success of the underlying patent litigation • On the state front - examining the new California Pay for Delay legislation: what have the implications and response been? » How have the first challenges to reverse-payment settlements under the new law panned out?

5:15 PM

Co-Chairs’ Recap 5:30 PM

Conference Concludes

AmericanConference.com/Life-Sciences-Antitrust • 888 224 2480

Part of C5 Group’s LIFE SCIENCES GLOBAL SERIES

Mark Parrish American Conference Institute

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