"Should Have Known" Standard Applied to CDA Statute of Limitations
Client Alert | 1 min read | 02.28.13
In what seems likely to be a major landmark in the evolving interpretation of the CDA statute of limitations, the ASBCA has held that the statute began to run in 1999, when a DCMA price analyst had all the information the government needed to recognize that it had a claim for an alleged CAS violation, even though the responsible CO may not have been aware of the claim until an audit report was issued in 2006. The ASBCA held that, in the absence of any evidence of trickery or concealment, the government "should have known" that it had a claim based on the contractor's 1999 cost proposal that appeared to be inconsistent with its disclosed accounting practice and that the government could not unilaterally extend the statute of limitations by failing to perform an audit that put the CO on actual notice that there might be a claim.
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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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