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Services In Contract Don't Trump "Non-Manufacturer Rule"

Client Alert | less than 1 min read | 09.13.06

In Rotech Healthcare Inc. v. United States (July 24, 2006), a pre-award bid protest of small business set-aside procurements, the Court of Federal Claims held that the Small Business Act's "non-manufacturer rule" requires recipients of small business set-aside contracts to provide products only of domestic small business manufacturers, even if the contract is for both products and services. Finding, inter alia, that the statute is "clear and unambiguous" in its application of the rule to "any" contract for the supply of a product, Judge Bush rejected government pleas for deference to SBA's less-restrictive applications of the rule and permanently enjoined set-aside awards to offerors who failed to certify compliance.

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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. ...

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