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Export Controls Biotechnology

Goodwin

The BIOSECURE Act and Its Potential Implications

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Proposed federal legislation known as the BIOSECURE Act is being considered in both the U.S. House of Representatives and the U.S. Senate....more

Jones Day

European Commission Signals Increased Scrutiny in Semiconductors, AI, Quantum Technologies, and Biotechnologies

Jones Day on

On October 3, 2023, the European Commission ("Commission") unveiled a list of 10 technology areas qualified as "critical" to the European Union's ("EU") economic security, out of which four (Semiconductors, AI, Quantum...more

Morgan Lewis

How China’s Detailed Human Genetic Resources Rules May Impact Multinational Life Science Companies

Morgan Lewis on

China’s Ministry of Science and Technology (MOST) officially announced on June 1, 2023 the release of the “Detailed Implementation Rules for the Management Regulations of Human Genetic Resources” (the Detailed HGR Rules)....more

Morrison & Foerster LLP

China Eyes New Export Controls for Life Sciences Technologies

China is considering new export restrictions on advanced technologies, including, in particular, in the life sciences sectors. In late December 2022, China’s Ministry of Commerce (“MOFCOM”) issued the proposed amendment to...more

Hogan Lovells

JPM2023 Trendspotting: evaluating CFIUS risks in the biotech sector

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As the industry readies itself for the January 2023 pilgrimage to the J.P. Morgan Healthcare Conference (JPM) and Biotech Showcase in San Francisco, our market-leading life sciences and health care industry team has prepared...more

Hogan Lovells

U.S. Government seeks to restrict biotechnology cooperation with China

Hogan Lovells on

The United States government is increasingly scrutinizing U.S. industry’s reliance on China for biotechnology research and development and manufacturing, and is taking steps to expand export control requirements on China that...more

Lowenstein Sandler LLP

Trade Matters, February 2022: A monthly newsletter covering global trade & national security developments

1. Treasury Mandates Reporting of Foreign Securities Holdings of $200M or More- All U.S. persons (custodians and end investors) who manage $200 million or more in foreign securities for themselves or others must file a...more

WilmerHale

United States Adopts Wide-Ranging China Restrictions

WilmerHale on

End-of-Year Sanctions Target Chinese Supply Chains and AI, Quantum Computing, and Biotechnology - Several US executive branch agencies and the US Congress have adopted wide-ranging end-of-year sanctions, export control and...more

Vinson & Elkins LLP

BIS Expands Export Controls over Biotechnology Software with Implications for CFIUS Mandatory Filing Requirements

Vinson & Elkins LLP on

On October 5, 2021, the Bureau of Industry and Security (“BIS”) issued a final rule formally expanding its controls over the export of biotechnology software. ...more

Fenwick & West LLP

New Controls on Biotech Software May Restrict Exports, Trigger CFIUS Filings

Fenwick & West LLP on

On October 5, 2021, the U.S. Commerce Department’s Bureau of Industry and Security (BIS) published a final rule amending the Export Administration Regulations (EAR) to include new controls on genetic editing software and...more

Goodwin

Commerce Department Proposes New Export Controls On Gene-Editing Software That Will Also Expand The Scope Of Mandatory CFIUS...

Goodwin on

On Friday, November 6, 2020, the Commerce Department’s Bureau of Industry & Security (BIS) issued a Notice of Proposed Rulemaking (NPRM) seeking public comment regarding newly-proposed controls on certain software for...more

Akin Gump Strauss Hauer & Feld LLP

MedTech Update 2020: Legal and Regulatory Issues to Watch For in the Medical Technology Industry in the New Year

Medical device and diagnostics companies and laboratories should anticipate significant legal, regulatory and market changes in 2020 that will have a lasting impact on the industry. From revisions to how the government...more

Jones Day

Facing FIRRMA: CFIUS Review of the Biotechnology and Life Sciences Sector

Jones Day on

The Situation: The Committee on Foreign Investment in the United States ("CFIUS," or the "Committee") recently published draft regulations implementing the Foreign Investment Risk Review Modernization Act ("FIRRMA"), which...more

Williams Mullen

New Export Requirements for Emerging and Foundational Technologies

Williams Mullen on

The U.S. is adopting a major change in the export control laws. Under the recently enacted Export Control Reform Act of 2018 (“ECRA”), the Commerce Department is imposing a new category of export controls on “emerging” and...more

Skadden, Arps, Slate, Meagher & Flom LLP

US Department of Commerce Solicits Comments Regarding Emerging Technologies That Are Essential to US National Security

On November 19, 2018, the Bureau of Industry and Security, U.S. Department of Commerce (BIS) published an advance notice of proposed rulemaking (ANPRM) soliciting comments on the criteria to be used to identify emerging...more

Dechert LLP

New Government Regulation of Emerging Technology

Dechert LLP on

The U.S. Government has instituted a major new initiative to regulate emerging technology, potentially including artificial intelligence, biotechnology, robotics, data analytics and many other types of emerging technology,...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

Settlement Highlights Need for Compliance with U.S. Export Control Rules When Sponsoring Foreign Workers

The U.S. Department of Commerce’s Bureau of Industry and Security recently reached a $115,000 civil settlement agreement with a California-based global technology company on the basis that it violated several export control...more

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