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The New FIRRMA Regulations and Their Impact on Biotechnology and Life Science Industries

  • Fri, June 25, 2021
  • 09:00 - 10:00

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Fri, June 25, 2021, 09:00 – 10:00AM (PDT), 12:00 – 1:00PM (EST)

Abstract 

Recently, new FIRRMA final regulations have been published.  The webinar will review how these regulations came to be, how they operate and how they are impacting the investment world, in both intended and unintended ways.

 

Recently, new FIRRMA final regulations have been published to further clarify the definition of “sensitive personal data” which was previously left to be developed by CFIUS. The final regulations clarify the provision on genetic testing in two ways: 1) by focusing the definition on genetic tests and 2) by limiting the coverage of the rule to identifiable data. The final regulations implement CFIUS’s jurisdiction over 11 specific categories of sensitive personal data, including health, biometric, and genetic data. CFIUS now have expanded jurisdiction over U.S. companies that collect or maintain records relating to a U.S. citizen's genetic information, such as a genetic test or individual or family history, which biotechnology or life sciences companies might collect and could lead to CFIUS review. CFIUS will closely monitor biotechnology and life sciences companies that operate in these relevant sectors and identify transactions in which a foreign investment raises a national security concern.


Speaker:


Ed Lebow: Ed Lebow has been skillfully representing clients in international trade cases for more than 30 years. Through years of providing insightful counsel to both domestic and foreign companies, Ed has developed a broad and comprehensive perspective, which he brings to his clients’ business needs.

Ed obtains relief for U.S. industries injured by dumped or subsidized imports and successfully defends foreign companies against such actions. He is especially adept in advising clients on how to comply with U.S. trade laws and avoid costly legal proceedings. Ed regularly deals with OFAC sanctions, export controls, NAFTA, anti-bribery issues under the Foreign Corrupt Practices Act (FCPA), and customs matters. Ed has guided both foreign buyers and domestic sellers of companies with sensitive technologies through the inter-agency Committee on Foreign Investment in the United States (CFIUS). Ed has also represented both U.S. and foreign clients before Congress.

Prior to private practice, Ed served as an Assistant General Counsel of the U.S. International Trade Commission. Ed also headed the ITC’s Section 337 staff office. Drawing on this experience, Ed is well-versed in handling Section 337 proceedings involving patent infringement and other unfair trade practices.


Angela Kwok is currently the General Counsel of Leszath Pharma, Inc, a pharmaceutical start-up company. Before that, she worked for several law firms in Silicon Valley. She is an experienced corporate attorney who provides strategic solutions to clients in Silicon Valley/San Francisco Bay Area, specializing in startups, venture capital financing, M&A, private equity/venture capital fund formation and CFIUS issues related to cross-border transactions.


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@Dahshu 2020

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