News & Analysis as of

Life Sciences Export Controls

The Volkov Law Group

Life Sciences Company Escapes Criminal Charges for Employee’s Illegal Export Scheme

The Volkov Law Group on

Sigma-Aldrich, Inc., d/b/a MilliporeSigma (“MilliporeSigma”), a U.S. life sciences company based in Massachusetts, escaped criminal charges for export control violations, despite a former sales person’s scheme to illegally...more

Jones Day

EU Emergency Response Update – Key Policy & Regulatory Developments No. 110

Jones Day on

This regular alert covers key regulatory developments related to EU emergency responses, including in particular to Russia’s war of aggression against Ukraine, COVID-19, and cyber threats. It does not purport to provide an...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

Impact of potential Russia sanctions on the life sciences industry

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There are two parallel sanctions processes unfolding in Washington, D.C. – one from the Biden administration and the other from the U.S. Congress. Regardless of what approach the government takes, we do not expect the life...more

Morgan Lewis

CFIUS Concerns in Life Science Investment and Venture Capital Transactions

Morgan Lewis on

There has been a significant increase in cross-border investment (FDI) in the US life sciences industry, including both medtech and biopharmaceutical companies. Determining if life sciences companies, particularly those in...more

Foley Hoag LLP

Department of Commerce Expands Export Controls Related to Certain Life Sciences Software

Foley Hoag LLP on

Effective October 5, 2021, the U.S. Department of Commerce’s Bureau of Industry and Security (BIS) released a final rule applying export controls to software (a) designed for certain nucleic acid assemblers and synthesizers...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

American Conference Institute (ACI)

[Complimentary Webinar] Mitigating Sanctions and Export Control Risks for Life Sciences, Research Institutes and Universities -...

Global life sciences companies, research institutes, and universities face unique challenges when complying with U.S. and non-U.S. trade control laws, including complying with general and specific licenses authorizing...more

Morgan Lewis

EU Imposes Authorization Requirements for COVID-19 Vaccine Exports

Morgan Lewis on

In response to delayed EU shipments of certain COVID-19 vaccines to the European Union, the European Commission (Commission) passed on 29 January 2021 Regulation 2021/111 (Export Authorization Regulation) which is in force...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

King & Spalding

General Counsels Decision Tree for Investigations of Life Sciences Companies

King & Spalding on

Manufacturers and distributors of health care products, including pharmaceuticals, biologics, medical devices and diagnostics regularly face challenges that may require an internal investigation to determine the root cause of...more

Hogan Lovells

Appealing a denial of a drug/medical device export certificate: FDA final guidance

Hogan Lovells on

Drug and medical device manufacturers seeking to export a product from the United States may need to obtain from the U.S. Food and Drug Administration (FDA) a Certificate to Foreign Government (CFG) in order to satisfy the...more

Jones Day

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

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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

Fenwick & West LLP

Shaking up Terra FIRRMA: Implications of CFIUS Reform for Tech and Life Sciences Companies

Fenwick & West LLP on

The shadow cast over the technology industry by the Committee on Foreign Investment in the U.S. has been growing in recent years, resulting in the blocking of various high-profile technology deals—including Broadcom’s...more

Hogan Lovells

Artificial Intelligence and your business: A guide for navigating the legal, policy, commercial, and strategic challenges ahead

Hogan Lovells on

Virtually all industries are being reshaped with the use of Artificial Intelligence and advanced machine-learning. Everything from healthtech to self-driving vehicles, to education and smart homes, drones and space, social...more

Arnall Golden Gregory LLP

United Medical Instruments Inc. Settles Potential Civil Liability for Alleged Violations of the Iranian Transactions and Sanctions...

On February 28, 2017, United Medical Instruments, Inc. (UMI), a California corporation, settled its potential civil liability with the U.S. Department of the Treasury’s Office of Foreign Assets Control (OFAC) in the amount of...more

Arnall Golden Gregory LLP

Update on Life Sciences Exports to Iran and Sudan

On September 28, the Office of Foreign Assets Control (OFAC) at the U.S. Department of the Treasury issued its Biennial Report of Licensing Activities Pursuant to the Trade Sanctions Reform and Export Enhancement Act of 2000,...more

Arnall Golden Gregory LLP

Every U.S. Life Sciences Company Needs an Export Control Compliance Program (No, Really….)

Two recent settlements by the U.S. Department of the Treasury’s Office of Foreign Assets Control (OFAC) confirm that every U.S. life sciences company engaging in exports should have an effective U.S. export control compliance...more

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