On August 22, 2024, the United States Department of Justice (DOJ) filed a Complaint-In-Intervention (the “Complaint”) against the Georgia Institute of Technology (Georgia Tech) and Georgia Tech Research Corp. (GTRC). The...more
On July 22, 2024, the Department of Treasury, Office of Foreign Assets Control (OFAC) announced a significant planned extension to its recordkeeping requirements, which will increase the retention period from five to ten...more
Aristotle said “well begun is half done.” About 2,300 years later, Mary Poppins shared the same advice with her young charges, Jane and Michael. The adage generally is understood to mean that a thoughtful and disciplined...more
In 2019, the Department of Justice created the Procurement Collusion Strike Force (PCSF or Strike Force), a joint law enforcement effort to combat antitrust crimes and related fraudulent schemes that impact government...more
As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...more
1/26/2024
/ Acquisitions ,
Amgen v Sanofi ,
Antitrust Division ,
Artificial Intelligence ,
Biden Administration ,
Biosimilars ,
Chevron Deference ,
Clawbacks ,
Clinical Trials ,
Compensation ,
Compliance ,
Corporate Integrity Agreement ,
Criminal Prosecution ,
Data Preservation ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Drug Pricing ,
Enforcement ,
EU ,
Executive Orders ,
False Claims Act (FCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Investigations ,
Life Sciences ,
Mergers ,
Mobile Devices ,
OPDP ,
Pharmaceutical Industry ,
Pilot Programs ,
Privacy Laws ,
Proposed Rules ,
Risk Management ,
Section 340B ,
Self-Disclosure Requirements ,
Voluntary Disclosure
On December 14, 2023, with bipartisan support, Congress passed the Foreign Extortion Prevention Act (“FEPA”), making it a federal crime for any foreign government official to demand, receive, or agree to receive a bribe from...more
Written by Paul Desmond in the key of E-flat minor and performed by the Dave Brubeck Quartet using a funky quintuple (5/4) time, “Take Five” is and was the biggest selling jazz single of all time. But it is also slang for...more
At the Global Investigations Review Annual Meeting in New York on September 21, 2023, Principal Associate Deputy Attorney General Marshall Miller (“Miller”) delivered remarks that provide an invaluable glimpse into the...more
9/26/2023
/ Acquisitions ,
Corporate Counsel ,
Corporate Crimes ,
Corporate Social Responsibility ,
Department of Justice (DOJ) ,
Enforcement Priorities ,
Mergers ,
National Security ,
Self-Disclosure Requirements ,
Transparency ,
Voluntary Disclosure ,
White Collar Crimes
In one of the final cases of a tumultuous term at the Supreme Court, the Justices ruled against DOJ in a decision that could have wide ranging effects not just for physicians and other prescribers, but for drug control laws...more
The inattention some companies pay to their ethics and compliance program never ceases to surprise us. You’d think the frequency of DOJ press releases and prosecutions holding companies accountable for employee wrongdoing...more
On March 2, Deputy Assistant Attorney General Richard Powers laid out a significant and aggressive criminal enforcement agenda for the Antitrust Division of the Department of Justice. While speaking at the the ABA National...more
The coronavirus pandemic has proven to be the most significant business crisis in global history. What will it take for multinational companies to aptly respond to the crisis while managing potential future harm from the...more
6/4/2020
/ Audits ,
Coronavirus/COVID-19 ,
Crisis Management ,
Defense Production Act ,
Enforcement Actions ,
Federal Loans ,
Investigations ,
OIG ,
Paycheck Protection Program (PPP) ,
Relief Measures ,
Small Business Loans
The University of Kentucky (“UK”) announced that it had fired all the coaches of its powerhouse cheerleading team on May 18, 2020 after a three-month internal investigations into allegations of hazing, public nudity, lewd...more
Approaching organizational integrity to resolve reputational threats before and after they may occur requires accounting for corporate values, public trust, corporate stakeholders, and reputation while seeking out and...more
The U.S. Department of Education is just now starting to pay attention to a reporting requirement in the Higher Education Act (HEA) that harkens back to the 1980s. Penalties for failure to properly report can be stark,...more
A few years back, two of us had the privilege of joining a highly trained SWAT team in New Orleans responding to a call for a barricaded subject with an assault rifle. To be clear, by “joining” we mean observing from the...more
U.S. Attorney’s Offices (“USAOs”) across the country are issuing warning letters to physicians and other prescribers (collectively, “Prescribers”) cautioning them about their opioid prescribing practices (the “Warning...more
2/7/2019
/ Criminal Investigations ,
DEA ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Opioid ,
Pharmaceutical Industry ,
Pharmacies ,
Physicians ,
Prescription Drugs ,
Regulatory Oversight ,
Risk Mitigation ,
U.S. Attorney ,
Warning Letters
• Emerging technology sectors are being reviewed now for new export controls that could take effect in 2019 (list below).
• You may submit comments on the criteria the U.S. government will use to determine what technologies...more
12/11/2018
/ Comment Period ,
Critical Infrastructure Sectors ,
Cross-Border Transactions ,
Emerging Technology Companies ,
Export Controls ,
Exports ,
Foreign Nationals ,
National Security ,
Proposed Rules ,
Public Comment ,
Technology Sector
In 2012, the Penn State Lions went 8-4 on the field, passing 3,283 yards, rushing 740 yards, and scoring 349 points. This credible performance earned it a respectable 38th ranking out of the 124 schools in the NCAA’s Division...more
10/31/2018
/ Coaches ,
College Athletes ,
Colleges ,
Corporate Culture ,
Corporate Governance ,
Crime Statistics ,
Criminal Justice Reform ,
Criminal Prosecution ,
Disclosure Requirements ,
Education Reform ,
Educational Institutions ,
Internal Investigations ,
Police ,
Policies and Procedures ,
Professors ,
Risk Mitigation ,
School Safety ,
Students ,
Teachers ,
Universities
1. All sanctions on Iran that were in place before January 2016 will be re-imposed no later than November, 4 2018.
2. Secondary sanctions that penalize non-U.S. persons doing business with Iran will be reinstated.
3....more
5/14/2018
/ Economic Sanctions ,
Exports ,
Foreign Financial Institutions (FFI) ,
Foreign Policy ,
Foreign Relations ,
General Licenses ,
Goods or Services ,
Imports ,
Iran ,
Iran Sanctions ,
Joint Comprehensive Plan of Action (JCPOA) ,
NDAA ,
Office of Foreign Assets Control (OFAC) ,
SDN List ,
Trump Administration