Regulators expect companies to investigate actual or potential violations completely and to disclose the nature and scope of those violations completely, in order to obtain credit for their disclosures. Identifying violations...more
President Donald Trump issued Executive Order 13936 on July 14 titled “The President’s Executive Order on Hong Kong Normalization” (the Executive Order or EO 13936). On the same day, the Hong Kong Autonomy Act (HR 7440) was...more
7/29/2020
/ China ,
Economic Sanctions ,
Executive Orders ,
Hong Kong ,
Hong Kong Autonomy Act (HKAA) ,
National Security ,
Office of Foreign Assets Control (OFAC) ,
Preferential Trade Status ,
Risk Management ,
SDN List ,
Trump Administration
Mexican President Andrés Manuel López Obrador recently announced that Mexico is willing to ship gasoline to Venezuela notwithstanding the threat of US sanctions against such activity. ...more
This LawFlash provides an overview of the recent executive order limiting the US use of bulk-power system equipment produced by “foreign adversaries,” initial guidance on key questions, and issues that will remain unresolved...more
FEMA exercised the authority recently granted to it by Executive Orders and pursuant to the Defense Production Act to regulate and redirect respirators, surgical masks, gloves, and other personal protective equipment (PPE) ...more
4/15/2020
/ Coronavirus/COVID-19 ,
Crisis Management ,
Defense Production Act ,
Export Controls ,
Federal Contractors ,
FEMA ,
Medical Supplies ,
Personal Protective Equipment ,
Price Gouging ,
Public Contracts ,
Supply Chain
The CFIUS real estate regulations reflect a new emphasis on real estate transactions based on proximity to military installations and certain critical infrastructure, requiring careful analysis when deciding whether a real...more
Although the overall goal of increasing pressure on Iran through sanctions remains official policy, the Trump administration on March 30 again extended the civilian-nuclear cooperation waiver allowing non-US companies to...more
Released last month by the Committee on Foreign Investment in the United States, the Geographic Reference Tool is a useful starting point in determining what constitutes covered real estate transactions, but does not provide...more
Autonomous cars, sports betting, and CBD products have burst onto the scene, setting the stage for major developments in how companies do business and how regulators monitor new innovations....more
2/10/2020
/ Affordable Care Act ,
Appropriations Bill ,
Automotive Industry ,
Big Data ,
Bioengineering ,
Cannabidiol (CBD) oil ,
Cannabis Products ,
CFIUS ,
Covered Transactions ,
Critical Infrastructure Sectors ,
Cross-Border Transactions ,
Cyber Attacks ,
Cybersecurity ,
Decriminalization of Marijuana ,
Final Rules ,
FIRRMA ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Safety ,
Food Supply ,
Foreign Investment ,
Health Insurance ,
Healthcare Reform ,
Intellectual Property Protection ,
Legislative Agendas ,
Marijuana ,
Medicaid ,
Medical Foods ,
National Security ,
Oil & Gas ,
Pipelines ,
Plant Based Products ,
Recreational Use ,
Retail Market ,
Sports Betting ,
Sports Gambling ,
Standard Essential Patents ,
Taxation ,
USDA
On January 13, the Committee on Foreign Investment in the United States (CFIUS) published the final rules implementing the Foreign Investment Risk Review Modernization Act (FIRRMA). ...more
The US Department of the Treasury’s Committee on Foreign Investment in the United States (CFIUS) on January 13 published the final rules implementing the Foreign Investment Risk Review Modernization Act (FIRRMA). FIRRMA...more
On September 17, 2019, the Committee on Foreign Investment in the United States (CFIUS or the Committee) issued proposed regulations implementing the remaining aspects of the Foreign Investment Risk Review and Modernization...more
The Committee on Foreign Investment in the United States (CFIUS) on September 17 released its long-awaited proposed regulations implementing many aspects of the Foreign Investment Risk Review and Modernization Act of 2018...more
EU – REGULATORY -
Brexit, Notified Bodies, and Medical Devices -
The House of Commons Library published a briefing paper on June 12 on the UK’s product standards and safety marking compliance in light of Brexit. In the...more
8/20/2019
/ Anti-Kickback Statute ,
Asia ,
China ,
Competition ,
Data Privacy ,
Drug Pricing ,
EU ,
Food and Drug Administration (FDA) ,
Intellectual Property Protection ,
Life Sciences ,
Medical Devices ,
Patents ,
Pharmaceutical Industry ,
UK Brexit
The Trump administration has issued a fourth set of proposed tariffs on an additional $300 billion of goods related to China, this time adding a range of commercial goods across industries. This round affects medical devices...more
On a fourth go-around, the Trump administration has issued another set of proposed tariffs on an additional $300 billion of goods related to China, this time adding a range of commercial goods across industries. With respect...more
To address national security interests and prevent the unauthorized transfer of scientific and technical information to certain foreign entities, the US Department of Energy (DOE) issued Order No. 486.1 on June 7. ...more
The US Department of Energy (DOE) issued Order No. 486.1 on June 7 prohibiting DOE employees and contractors from participating in the foreign government “talent recruitment programs” of countries designated by the DOE as a...more
US persons who have engaged in wind-down or maintenance transactions with EN+ Group, UC Rusal, or JSC EuroSibEnergo (or entities they own or control) pursuant to General License 14E or 16E must report those transactions to...more
With many companies focused on analyzing transactions for applicability of the Committee on Foreign Investment in the United States’ (CFIUS or Committee) pilot program mandatory declaration requirements, transacting parties...more
The August 2018 enactment of the Foreign Investment Risk Review Modernization Act (FIRRMA) came after more than two years of debate over the appropriate scope of jurisdiction for the Committee on Foreign Investment in the...more
As the public focuses attention on the influence of foreign investment in mergers and acquisitions, the national security apparatus continues to highlight the need to examine foreign influence in other areas of the economy,...more
After the decision to terminate US participation in the Joint Comprehensive Plan of Action, most EAR99 medical devices remain covered by general licenses for export or re-export to Iran, but medical device companies will need...more
The Office of Foreign Assets Control recently designated 7 “oligarchs,” 17 government officials, 13 companies, and one bank, all Russian, as Specially Designated Nationals (SDNs), effectively prohibiting US persons...more
The new sanctions fall within the framework of existing US sanctions against Russia, but have expanded their application by classifying new, prominent individuals and companies as “Specially Designated Nationals.” Given the...more