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“Good” Enough: Court Finds Certification Merely Defective on Pass-Through Claim

Client Alert | 1 min read | 05.04.16

In M.K. Ferguson Co. v. U.S. (Apr. 14, 2016), a case involving a pass-through claim compelled by the prime’s bankruptcy judge, the CFC denied the government’s motion to dismiss and held that the prime’s initial pass-through certification – which stated only that the prime was “authorized to certify the claim” – was not a “failure to certify” (which would have cost the court its jurisdiction) but was instead a “defective certification” that the prime could (and did) cure through its subsequent certification. Although the prime contractor had previously expressed “legitimate concerns as to the amount claimed” to the bankruptcy judge, the CFC concluded that the prime’s compliance with the bankruptcy court’s order showed the prime’s sponsorship was made in “good faith” and remanded to the agency for a final decision, after holding that the prime’s potential liability to the subcontractor (despite the discharge of liability in bankruptcy) was enough to satisfy the “modern” Severin doctrine.

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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. ...