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ASBCA Decision a Mixed Bag on Cost Allowability Issues

Client Alert | 1 min read | 05.17.17

In Raytheon Co., ASBCA No. 57743, et al., the Board addressed penalties associated with various unallowable costs, finding that salaries of employees engaged in unallowable lobbying activities were “expressly unallowable” as “directly associated costs,” and subject to level 1 penalties, even though “directly associated costs” are, by definition, not expressly unallowable. The Board also found that costs that Raytheon had previously agreed to treat as unallowable, but erroneously included in incurred cost submissions, were not subject to level 1 penalties because they were not expressly unallowable (the Government apparently did not argue that such costs were subject to level 2 penalties). Finally, the Board held that testimony and other credible evidence can be used to demonstrate allowability of consultant costs in the absence of perfect documentation, and that a contractor must prove the CO’s failure to waive penalties for expressly unallowable costs is an arbitrary and capricious abuse of discretion.

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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. ...