For several years, policy-makers and commentators have expressed concern about the resilience of the United States’ pharmaceutical supply chain. Current U.S.-based manufacturing capabilities have been at the forefront of...more
10/8/2021
/ Biden Administration ,
Biomedical Advanced Research and Development Authority (BARDA) ,
China ,
Competition ,
Coronavirus/COVID-19 ,
Defense Production Act ,
Department of Defense (DOD) ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Manufacturers ,
NDAA ,
Pharmaceutical Industry ,
Supply Chain
Key Points -
On Wednesday, May 12, 2021, President Biden issued EO 14,028, “Improving the Nation’s Cybersecurity.” The EO sets out an ambitious schedule of reviews and rulemakings that portend significant changes in the...more
In this episode, Akin Gump government contracts partner Angela Styles discusses the origins, workings, track record and future of the Paycheck Protection Program (PPP).
Among the topics covered:
- Self-certification,...more
4/9/2021
/ Acquisitions ,
CARES Act ,
Eligibility ,
Fraud ,
Loan Forgiveness ,
Paycheck Protection Program (PPP) ,
Payroll Expenses ,
SBA ,
Self-Certification ,
Small Business ,
Small Business Loans ,
U.S. Treasury
Key Points
- Enacted as part of the 2021 NDAA, the Act will require companies with no prior anti-money laundering reporting requirements to submit beneficial ownership information to FinCEN.
- FinCEN must issue...more
Key Points
- On December 27, 2020, the new stimulus package appropriating an additional $284.45 billion for the PPP was signed into law.
- The categories of eligible uses for loan proceeds and forgiveness are...more
Key Points
- On October 26, 2020, the SBA announced its intent to require a Necessity Questionnaire for borrowers that received PPP loans of $2 million or greater.
- The SBA intends to use the Necessity Questionnaire...more
On August 6, President Trump issued an Executive Order (EO) titled “Ensuring Essential Medicines, Medical Countermeasures and Critical Inputs Are Made in the United States.” The far-reaching EO seeks to ensure the domestic...more
8/13/2020
/ Best Practices ,
Coronavirus/COVID-19 ,
Counterfeiting ,
Department of Defense (DOD) ,
Department of Health and Human Services (HHS) ,
Department of Homeland Security (DHS) ,
E-Commerce ,
Executive Orders ,
Exemptions ,
Food and Drug Administration (FDA) ,
Free Trade Agreements ,
Health and Safety ,
Imports ,
Infectious Diseases ,
Manufacturers ,
Medical Supplies ,
OMB ,
Personal Protective Equipment ,
Pharmaceutical Industry ,
Prescription Drugs ,
Procurement Guidelines ,
Public Health ,
Reporting Requirements ,
Section 301 ,
Supply Chain ,
Trump Administration ,
Waivers ,
WTO
- Akin Gump is hosting a Webinar tomorrow, August 6, 2020, at 12:00 p.m. (EST) to discuss Section 889, the implementing regulations, and the grant and loan restrictions also effective August 13, 2020.
- On July 14, 2020,...more
8/5/2020
/ Department of Defense (DOD) ,
Federal Acquisition Regulations (FAR) ,
Federal Contractors ,
General Services Administration (GSA) ,
Interim Final Rules (IFR) ,
NASA ,
NDAA ,
Prime Contractor ,
Public Comment ,
Reporting Requirements ,
Subcontractors ,
Supply Chain ,
Surveillance ,
Telecommunications
- The Department of Justice (DOJ) will focus its civil enforcement activity on fraud and other illegal actions relating to COVID-19, including with respect to CARES Act stimulus programs and consumer products marketed for use...more
7/6/2020
/ CARES Act ,
Coronavirus/COVID-19 ,
Corporate Counsel ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Fraud ,
Main Street Lending Programs ,
Paycheck Protection Program (PPP) ,
Private Equity Firms ,
Qui Tam
- Both chambers of Congress have passed the Paycheck Protection Program Flexibility Act of 2020. The bill now heads to President Trump’s desk for his signature.
- The measure extends the Paycheck Protection Program loan...more
6/5/2020
/ Borrowers ,
Business Expenses ,
CARES Act ,
Loan Forgiveness ,
New Legislation ,
Paycheck Protection Program (PPP) ,
Paycheck Protection Program Flexibility Act of 2020 (PPPFA) ,
Payroll Taxes ,
Safe Harbors ,
Small Business ,
Small Business Loans
A. Introduction and Key Take-Aways -
The Department of Defense’s (DOD) Cybersecurity Maturity Model Certification (CMMC) program provides a metric for independent third parties to use in assessing and certifying the...more
6/4/2020
/ Competition ,
Confidential Information ,
Conflicts of Interest ,
Controlled Unclassified Information (CUI) ,
Cybersecurity ,
Cybersecurity Maturity Model Certification (CMMC) ,
Defense Costs ,
Defense Sector ,
Department of Defense (DOD) ,
DFARS ,
Federal Acquisition Regulations (FAR) ,
Federal Contractors ,
Subcontractors ,
Supply Chain
On Friday, April 24, 2020, the Small Business Administration (SBA) published an Interim Final Rule (IFR) governing the Paycheck Protection Program (PPP) of the Coronavirus Aid, Relief and Economic Security Act (CARES Act). In...more
- The government has pledged to prioritize investigations and prosecutions regarding alleged frauds related to coronavirus programs.
- The False Claims Act is the government’s primary enforcement tool to prosecute alleged...more
- The Paycheck Protection Program (PPP), contained within the stimulus package signed by President Trump on March 27, 2020, creates a $349 billion loan facility to help “small” businesses make payroll and pay certain other...more
Loans Under Paycheck Protection Program (Section 1102) -
Section 1102 provides $350 billion for expedited individual loans up to $10 million through approved lenders that are guaranteed 100 percent by the U.S. government....more
The Defense Production Act (DPA) of 1950 (50 U.S.C. §§ 4501 et seq.) grants the President broad authority to prioritize and allocate health resources. This includes two very separate and distinct authorities to (1) “require...more
Key Points
- On January 22, 2020, the Office of Management and Budget (OMB) proposed changes to its grants and agreements regulations (2 CFR Part 200) to implement § 889 of the National Defense Authorization Act (NDAA)...more
1/28/2020
/ China ,
Code of Federal Regulations (CFR) ,
Comment Period ,
Cooperative Agreements ,
Critical Infrastructure Sectors ,
Federal Acquisition Regulations (FAR) ,
Federal Contractors ,
Huawei ,
NDAA ,
OMB ,
Procurement Guidelines ,
Proposed Regulation ,
Telecommunications
• On August 7, the DOD, GSA, and NASA released a prepublication version of an Interim Final Rule implementing paragraph (a)(1)(A) of § 889 of the 2019 NDAA. The rule is effective next Tuesday, August 13, 2019.
• Among its...more
8/12/2019
/ CFIUS ,
Department of Defense (DOD) ,
Federal Acquisition Regulations (FAR) ,
Federal Contractors ,
FIRRMA ,
General Services Administration (GSA) ,
Interim Final Rules (IFR) ,
NASA ,
NDAA ,
New Rules ,
Public Comment ,
Reporting Requirements ,
Surveillance ,
Telecommunications
• The Department of Justice (DOJ) has adopted a policy to incentivize companies and individuals to voluntarily disclose civil False Claims Act (FCA) violations, cooperate with government investigators and undertake effective...more