Clearing The Decks--FAR Council Finally Issues COTS Waivers Mandated By Clinger-Cohen Act of 1996
Client Alert | 1 min read | 01.23.09
Six years after the initial advance notice of proposed rulemaking, on January 15, 2009, the FAR Council issued its final rule identifying additional statutory requirements to be waived when the government purchases commercial, off-the-shelf equipment as narrowly defined in the Clinger-Cohen Act of 1996 (commercial items, sold in substantial quantities in the commercial marketplace, and offered to the government without modification), relieving COTS procurements from compliance with only one statute of significance--the Buy American Act, but significantly not the Trade Agreements Act (applicable to many of the GSA schedule and other contract vehicles under which the government buys COTS items)--and even then the new rule provides only a partial waiver: the item must still be "manufactured" (an undefined term) in the United States, but the origin of the components will no longer be relevant in determining the country of origin for COTS items. Neither this final FAR rule nor a separately published interim DFARS rule (that effectively provided a similar partial waiver) limits or revokes the existing waiver provided as a result of annual authorization act provisions wholly exempting from the Buy American Act information technology products that qualify under the broader definition for commercial items.
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Client Alert | 7 min read | 09.14.26
AI in Life Sciences: Ten Legal Considerations and Risks of AI Use in Drug Discovery and Development
Over the past several years, the biopharmaceutical industry has embraced artificial intelligence and machine learning (AI/ML) in near lockstep with the pace of AI/ML innovations. Today, industry leaders are using AI/ML to, among other things: discover and assess biological pathways, target chemical structures and sequences; design proteins; model pre-clinical and clinical trials; recruit and screen potential patient populations; evaluate clinical trial results and biomarker data; prepare regulatory filings; and manage supply chains. Deployment of new AI/ML models promises extraordinary advances in pharmaceutical development. However, as with any technological and scientific advances, the use of AI/ML also poses substantial legal risks that life sciences companies need to consider and proactively manage.
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