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IR&D Reporting Requirements Reinstated

Client Alert | 1 min read | 01.30.12

In a final rule published today, the DFARS were amended to reinstate a requirement that was eliminated from the regulations in the early 1990s, providing that as a condition of allowability for Independent Research and Development (IR&D) costs, major contractors must submit to DoD at least annually technical descriptions of the IR&D projects that the contractor claims as allowable. In response to criticism of a draft regulation proposing a $50,000 coverage threshold, the final rule limits mandatory reporting to “major contractors” that allocate more than $11 million annually to “covered contracts” (a term that excludes fixed-price contracts without cost incentives), leaves largely to the contractor’s discretion how much detail needs to be reported in the on-line template through which the reports must be submitted, encourages voluntary reporting by contractors not subject to the mandatory requirement, and promises that the reports will be exempt from disclosure under the Freedom of Information Act.

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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. ...