Top Legal Developments that Every Life Sciences Company Needs to Watch: Part I

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Meet The Speakers

Lisl Dunlop
Partner, Litigation & Co-Chair, Antitrust Litigation, Manatt, Phelps & Phillips, LLP
Jordan E. Hamburger
Partner, Corporate and Finance, Capital Markets, & Mergers and Acquisitions, Manatt, Phelps & Phillips, LLP
Kimo S. Peluso
Partner, Litigation, Manatt, Phelps & Phillips, LLP
Helen Pfister
Partner, Health Care, Manatt, Phelps & Phillips, LLP
Marc Roth
Partner, Advertising, Marketing and Media Division & Co-Chair, TCPA Compliance and Class Action Defense Group, Manatt, Phelps & Phillips, LLP
Ian Spatz
Senior Advisor, Health Care, Manatt, Phelps & Phillips, LLP
Jacqueline Wolff
Partner & Co-Chair, Corporate Investigations and White Collar Defense Group, Manatt, Phelps & Phillips, LLP
Ted Wolff
Partner & Co-Chair, Energy, Environment and Natural Resources Group, Manatt, Phelps & Phillips, LLP


This is a complimentary program sponsored by Manatt, Phelps & Phillips, LLP.
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Life sciences companies are facing an increasingly complex legal climate, and it is easy to miss some of the storms on the horizon.  Some regulators are struggling to keep pace with a health care environment changing at unprecedented speed, while other agencies are now zeroing in on drug and device companies.  It can be a continuing challenge to ensure life sciences companies remain compliant – and protected – in a transforming environment.

In a new two-part program, Manatt addresses some of the most significant legal issues that life sciences leaders need to watch in the year ahead.  You’ll explore developments affecting the life sciences industry from numerous directions – including anti-corruption, environmental regulation, cybersecurity, Medicaid reform and direct marketing.  You will learn what your organization needs to know to ensure your business is prepared to address a host of legal developments and navigate safely through today’s volatile health care landscape.

Educational Objectives:
• Discover some of the most important, and surprising, legal developments on the horizon today for life sciences companies.
• Gain critical insights into how a number of critical developments are evolving – many of which come from outside the traditional areas in the sites of life sciences counsel.
• Explore developments and enforcement trends around antitrust laws, the False Claims Act (FCA), the Foreign Corrupt Practices Act (FCPA), the 340-B program, cybersecurity, direct marketing laws, environmental regulations, and others.
• Examine how life companies and their customers can respond to these developments to keep their organizations compliant and prepared in a radically-changing market.

Who would benefit most from attending this program?
Counsel for pharmaceutical, biotech and medical device companies, as well as compliance officers and executive leadership of life sciences organizations and their vendors.
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Lisl Dunlop, Partner, Litigation & Co-Chair, Antitrust Litigation, Manatt, Phelps & Phillips, LLP

Ms. Lisl Dunlop is a partner in the New York office and co-chair of the firm’s Antitrust practice group.  She advises leading U.S. and multinational companies in an array of industries – in particular in the media, technology and health care sectors – on a broad range of antitrust counseling, antitrust-related aspects of mergers and acquisitions, joint ventures and other combinations, and sales and distribution matters; represents clients in antitrust agency investigations; and has represented major corporations in complex antitrust litigations, including multidistrict treble damages class actions.  Ms. Dunlop has regularly been recognized as a leading antitrust lawyer in Chambers USA, Legal 500, Who’s Who Legal and Global Competition Review.

In addition to over 20 years of experience practicing U.S. antitrust law, Ms. Dunlop has significant international experience in both Australia and Europe.  Ms. Dunlop has appeared before U.S. federal and state antitrust enforcement agencies, the European Commission, and has coordinated the multijurisdictional defense of transactions throughout the world.  Ms. Dunlop’s experience in competition matters in a broad range of jurisdictions brings added value to clients that conduct business internationally and interact with different legal systems and regulators.

Ms. Dunlop is admitted to practice in New York, the District of Columbia, England and Wales, and Australia.  She earned her LL.M. from Cornell University Law School, her LL.B. from the University of Sydney, and her BSc from the University of Sydney.

Jordan E. Hamburger, Partner, Corporate and Finance, Capital Markets, & Mergers and Acquisitions, Manatt, Phelps & Phillips, LLP

Mr. Jordan Hamburger’s practice focuses on corporate and securities matters, including mergers and acquisitions, public and private securities offerings and other general corporate representation.  He regularly performs these services for entrepreneurs, middle market companies, private equity firms and other market participants in the financial services, health care and payments industries, among others.  Additionally, Mr. Hamburger advises public and private companies on corporate governance matters, and represents public companies in connection with securities law compliance and reporting, including compliance with NASDAQ and NYSE listing standards.

Prior to joining Manatt, Mr. Hamburger was an associate at an international law firm, where he specialized in mergers and acquisitions, securities and bank regulation.

Mr. Hamburger is admitted to practice in the states of California and New York and the District of Columbia. He earned his J.D., with honors, from the George Washington University Law School, his M.B.A. from the George Washington University, and his B.A. from Emory University.

Kimo S. Peluso, Partner, Litigation, Manatt, Phelps & Phillips, LLP

Mr. Kimo Peluso’s practice focuses on complex commercial litigation.  He has extensive experience handling disputes arising from business deals of every kind, as well as health care industry litigation, real estate cases, and lawsuits between competitors for false advertising and unfair competition.  He has also litigated cases involving the False Claims Act, antitrust, consumer protection, trademark, labor, employment and securities fraud, among other areas of the law.  In addition, he has defended clients in criminal matters and overseen internal investigations.  Mr. Peluso served as a law clerk to the Honorable Amalya L. Kearse, U.S. Court of Appeals for the Second Circuit.

Mr. Peluso is admitted to practice in New York State, the United States District Courts for the Southern District of New York, the Eastern District of New York, the Northern District of New York, the Eastern District of Wisconsin, and the District of Colorado, and the United States Courts of Appeals for the Second Circuit, Third Circuit and Eleventh Circuit.  He earned his J.D., magna cum laude, from Harvard Law School, where he was Managing Editor of the Harvard Law Review, and his B.A., summa cum laude, from the University of California, San Diego.

Helen Pfister, Partner, Health Care, Manatt, Phelps & Phillips, LLP

Ms. Helen Pfister is a partner in the health care practice group of Manatt, Phelps & Phillips, LLP.  Her practice focuses on advising health care organizations and nonprofit corporations on regulatory, policy and transactional matters.  Ms. Pfister’s clients include hospitals, pharmaceutical manufacturers, mental health facilities, substance abuse providers, nursing homes, home care agencies, health information exchange organizations and social service agencies.  Her areas of expertise include licensure, reimbursement, privacy and other regulatory issues.  She also has particular expertise representing federally qualified health center and other organizations that serve medically underserved communities.

Ms. Pfister has extensive experience in helping clients navigate the legal and political challenges of Medicare, Medicaid and other public health insurance programs, and is well-versed in a wide range of Medicaid reimbursement issues.  She has been increasingly involved in advising clients on payment and delivery system reform initiatives, including issues specific to accountable care organizations and other value-based payment initiatives.  She also has a strong transactional background, and frequently advises clients on acquisitions, joint ventures, corporate governance and related matters.  Ms. Pfister has been heavily involved in advising clients on the federal 340B prescription drug discount program.  Ms. Pfister is also involved in a range of projects involving the use of health information technology to facilitate the secure and timely exchange of health information to improve the quality and efficiency of health care delivery.  She represents several health information exchanges, and has worked on a number of projects to increase the participation of community health centers and other safety net providers in health information technology initiatives.  Prior to joining Manatt, Ms. Pfister was an attorney in the mergers and acquisitions practice of the law firm of Skadden, Arps, Slate, Meagher & Flom LLP.

Ms. Pfister is admitted to practice in New York.  She earned her J.D., magna cum laude, from Boston University School of Law, where she was an Articles Editor for the Boston University Law Review, and her B.A. from Cornell University.

Marc Roth, Partner, Advertising, Marketing and Media Division & Co-Chair, TCPA Compliance and Class Action Defense Group, Manatt, Phelps & Phillips, LLP

Mr. Marc Roth is a partner in the Advertising, Marketing and Media Division of Manatt, Phelps & Phillips, LLP and Co-Chair of the TCPA Compliance and Class Action Defense Group, resident in the firm’s New York office.  He is a highly accomplished regulatory and transactional attorney with over 20 years of experience in consumer advertising and marketing law.  Clients ranging from Fortune 100 and 500 companies to emerging and start-up firms turn to Mr. Roth for his expertise in privacy law, social media, telemarketing, claim substantiation, continuity and negative option marketing, loyalty programs, and magazine sales and audit rules.  Mr. Roth’s practice also includes defending clients before federal and state regulatory authorities.  Through his prior experience as an in-house Chief Compliance Counsel for a Time Warner company and FTC staff attorney, he offers a valuable perspective on the matters he handles for clients.

Mr. Roth is admitted to practice in New York and is Formerly Authorized House Counsel in Connecticut.  He earned his J.D. from Syracuse University, his M.A. of Public Administration from Maxwell School of Citizenship and Public Affairs, and his B.A. from Hobart  College.

Ian Spatz, Senior Advisor, Health Care, Manatt, Phelps & Phillips, LLP

Mr. Ian Spatz is a Senior Advisor in the national health care practice of Manatt, Phelps & Phillips, LLP and Manatt Health.  Mr. Spatz provides highly experience insights into ongoing health reform efforts, helps develop public and private strategies and guidance on a broad array of issues affecting health care providers and insurers, pharmaceutical companies, the consuming public and U.S. health care initiatives generally, as well as the development and implementation of communication and advocacy efforts at the federal and state levels.  Among his areas of expertise are national health care policies and programs; pharmaceutical pricing, including Medicare and Medicaid; intellectual property protection; and policies related to the U.S. Food and Drug Administration’s regulation of the research, approval, manufacturing and marketing of medicines.

Mr. Spatz is also the founder and principal of the policy consulting firm Rock Creek Policy Group, LLP.  Before founding Rock Creek Policy Group, Mr. Spatz served for 15 years in increasingly responsible positions with Merck & Co., Inc., one of the world’s leading research-based pharmaceutical and vaccine companies.  Before joining Merck, Mr. Spatz served as Legislative Director for U.S. Senator Frank Lautenberg (D-NJ), where he directed the Senator’s legislative staff including developing and supervising the implementation of legislative strategies, proposal drafting and floor action.  He began his career in the nonprofit sector where he led the public policy and government affairs activities of the National Trust for Historic Preservation, the nation’s leading heritage conversation organization.

Mr. Spatz is admitted to practice in Washington, D.C.  He earned his J.D. from New York University School of Law, his M.P.P. from Princeton University, Woodrow Wilson School of Public and International Affairs, and his B.A. from Brandeis University.

Jacqueline Wolff, Partner & Co-Chair, Corporate Investigations and White Collar Defense Group, Manatt, Phelps & Phillips, LLP

Ms. Jacqueline Wolff is the Co-chair of Manatt’s Corporate Investigations and White Collar Defense Group.  She has spent over 25 years defending companies and individuals accused of white collar crimes and False Claims Act (FCA) violations. A former Chief of the Environmental Crimes Unit and Assistant United States Attorney for the Frauds Division in the District of New Jersey, Ms. Wolff has successfully defended multiple life sciences and healthcare clients in False Claims Act cases resulting in declinations from the government, resolutions as overpayment cases or, where the government decided not to intervene, outright dismissals of the qui tam complaints.

While in the United States Attorney’s Office, Ms. Wolff received numerous awards, including from the Attorney General of the United States.

Ms. Wolff serves on the Advisory Board of Bloomberg BNA’s Pharmaceutical Law and Industry Report and the Board of Directors of the New York County Lawyer’s Association.  She is also a member of the Board of Editors of the Business Crimes Bulletin.

Ted Wolff, Partner & Co-Chair, Energy, Environment and Natural Resources Group, Manatt, Phelps & Phillips, LLP

Mr. Ted Wolff’s environmental practice includes both litigation and transactional work.  His litigation experience in federal and state, and administrative and judicial actions includes enforcement, creditor and debtor’s rights, cost recovery, Superfund, toxic tort (including groundwater, indoor air, and chemical exposure cases), regulatory compliance, and permitting-related matters.  Mr. Wolff also specializes in corporate compliance counseling, advising retail, real estate, industrial, manufacturing, food service, health care and other commercial and governmental clients on health, safety and environmental auditing, as well as development and implementation of corporate environmental management systems and sustainability programs.

Mr. Wolff frequently partners with technical consultants and other experts to oversee and perform internal environmental investigations and audits, together with evaluating disclosure and voluntary compliance strategies.  These audits assist and support client investigations or ongoing environmental compliance assessments, frequently including the development of compliance recommendations as well as strategies for mitigating or eliminating civil and criminal penalties by self-reporting to relevant environmental agencies. Mr. Wolff has also advised a broad array of industries, including medical device, pharmaceutical, retail, transportation, and heavy manufacturing to create corporate programs for environmental training, response, and day-to-day environmental compliance operations.  He regularly counsels clients on compliance with federal, state, and local environmental laws and rules which regulate air pollution; pesticides; hazardous substance and hazardous waste handling, storage, treatment, and disposal; asbestos handling, management, and abatement; and employee and community disclosure. Mr. Wolff’s experience also includes advising clients on environmental aspects of land transfers and on issues arising out of other real estate and corporate transactions.  Mr. Wolff also represents creditors and debtors in regard to environmental matters in bankruptcy.

Mr. Wolff is admitted to practice in New York and Illinois.  He earned his J.D. from the New York University School of Law and his B.A., with distinction and cum laude, from Colby College.