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DFARS Excessive Pass-Through Cost Rule Modified

Client Alert | 1 min read | 05.13.08

Effective May 13, 2008 (73 Fed. Reg. 27464), the widely-criticized interim DFARS rules about "excessive pass-through costs" published last April were modified in yet another interim rule to address the confusion created by the interim rules. The most important features of the new interim rules are in the prefatory comments, which emphasize repeatedly that the requirement for reporting when subcontract effort will exceed 70 percent applies both before and after award, but is only a reporting requirement, not a threshold for coverage, and that the rules do not apply to any contract, no matter what the subcontract content, where the contractor demonstrates "added value," a term that is defined in the interim regulations to include performance of "subcontract management functions that the Contracting Officer determines are a benefit to the Government (e.g., processing orders of parts or services, maintaining inventory, reducing delivery lead times, managing multiple sources for contract requirements, coordinating deliveries, performing quality assurance functions)."

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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. ...