In this episode, Michael E. Burke, partner and co-chair of the Pharmaceutical & Biotechnology industry team is joined by Robert Durkin, an attorney in our Dietary Supplements team, as they discuss issues around business...more
AGG is proud to present the latest installment of our AGG Talks podcast series on U.S. business bankruptcy. In this episode, AGG Bankruptcy partner Sean C. Kulka and Corporate partner Mike E. Burke discuss the basics of the...more
Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
Under the U.S. Foreign Corrupt Practices Act (“FCPA”), foreign health care professionals (“HCPs”) are considered “foreign officials” for purposes of the statute’s antibribery prohibitions and recordkeeping requirements. Most...more
A few weeks ago, AGG’s Food and Drug Practice Team launched its podcast series to discuss topics affecting the FDA-regulated industry. The series, called “I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues,”...more
AGG is proud to introduce our newest podcast series titled “I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues.” Each month, we will release a new podcast where different members of our Food and Drug practice...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of AGG outside the Food and Drug practice....more
In late June, the U.S. Department of Justice (“DOJ”) and Securities and Exchange Commission (“SEC”) announced that Novartis AG and Alcon Pte Ltd, a former subsidiary of the Swiss drug maker, agreed to pay a combined $347...more
On July 8, 2020, the U.S. Department of Treasury’s Office of Foreign Assets Control (“OFAC”) announced a $134,523 civil settlement with Amazon, Inc. (“Amazon”), for alleged violations of multiple OFAC sanction and embargo...more
On March 27, 2020, President Trump signed into law the Coronavirus, Aid, Relief and Economic Security Act (the “CARES Act”). The nearly $2 trillion relief package is the boldest action to date in response to the COVID-19...more
As we continue to learn more about the Coronavirus Aid, Relief and Economic Security Act (CARES Act), we are committed to sharing our knowledge and understanding of the bill with our clients.
In this webinar, we provided a...more
Fraud and corruption thrive in chaos. The COVID-19 pandemic and its economic destabilization create the conditions in which misconduct can thrive....more
My wonderful colleague, Rebecca Kolb, has written a terrific client alert, below, on whether, and how, business interruption insurance in the U.S. could cover COVID-19-related losses. Irish and NI companies with US operations...more
David Marmins, my incredibly talented partner, has written a great legal update on whether the coronavirus is a force majeure event in U.S. contract law. This is essential reading for any Irish or Northern Irish company with...more
As of early August, all Irish and Northern Irish persons and entities (whose permanent legal residence or principal place of business is outside the U.S.) are required to be represented by a licensed U.S. attorney in good...more
U.S. visa processing is growing in complexity, with many new U.S. operations of Irish/NI parent struggling to qualify for classification to sponsor qualified professionals for work authorization in the U.S . New U.S...more
My last post discussed the potential (but likely very small) impact of the relatively new U.S. steel and aluminum tariffs on Irish and Northern Irish exports to the U.S. In this post, I turn to the related question of whether...more
Several Irish and NI companies have asked me whether the recently-imposed US tariffs on aluminum and steel would impact their products–products that use/incorporate aluminum and steel. Much of the confusion stems from how the...more
Just back from a two-week swing through Belfast, Antrim (at a wonderful InvestNI program) Londonderry/Derry, Galway, and Dublin, meeting with companies looking to export to the U.S. One question that came up time and again:...more
On October 31, 2017, an amendment to the Corruption of Foreign Public Officials Act (“CFPOA”), Canada’s analog to the U.S. Foreign Corrupt Practices Act (“FCPA”), made illegal defined ‘facilitation payments.’ The CFPOA now...more
Register the IP you’ll use in the US, most likely your trademarks. Many Irish and Northern Irish companies mistakenly believe that their home jurisdiction trademark registrations will be effective in the US. Nope. Also, some...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
The first thing you should do when considering whether to export your product to the United States is determine whether the product can be marketed or sold in the United States, or if there are license or registration...more
A lot of ink has been spilled in projecting what Brexit (the UK’s withdrawal from the European Union) might look like, including in this space by this author. The simple fact is that we don’t know what Brexit will actually...more
On June 5, 2017, Saudi Arabia, Bahrain, and the United Arab Emirates cut diplomatic ties with, and imposed an economic embargo on, Qatar. U.S. life sciences companies should be mindful that support for or compliance with this...more