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FAR Council Introduces Limits on the Single-Offer Adequate Price Competition Exception

Client Alert | 1 min read | 07.01.19

On June 12, 2019, the FAR Council issued a final rule amending the FAR to address an exception from certified cost or pricing data requirements when price is based on adequate competition.  In particular, the final rule amends the definition of “adequate price competition” in FAR 15.403-1(c) for submission of certified cost or pricing data to DoD, NASA, and the Coast Guard so that the adequate price competition exception now applies only when “two or more responsible offerors, competing independently, submit priced offers that satisfy the Government’s expressed requirement.”  This means that if only one offer is received, even if submitted with the expectation of competition, the exception no longer applies.  For all other agencies, the exception still applies even when only one offer is received, provided there is a reasonable expectation that two or more responsible offerors would submit offers, or price analysis demonstrates that the proposed price is reasonable.  Though this rule represents a change to the FAR, we note that a similar rule has existed in the Defense Federal Acquisition Regulation Supplement at 215.371-3 for a number of years.

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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. ...