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 | 9 min read | 10.21.26
The life sciences sector is uniquely vulnerable to the inherent risks of AI-generated evidence in drug development and discovery. This client alert focuses on five core challenges: hallucinations, skewed predictions from unrepresentative training data, the opacity of AI reasoning, input sensitivity that undermines reproducibility, and adversarial manipulation of training data. To address these risks, companies should use experimental validation and human oversight as the common legal and regulatory safety net. This entails among other measures auditing AI outputs, characterizing training data, and structural oversight. Companies also should prepare for evolving frameworks and guidance from the U.S. Food and Drug Administration (FDA) and the European Union (EU) that address use of AI in drug discovery and development .
Client Alert | 2 min read | 10.21.26
Client Alert | 3 min read | 10.21.26
Private Investigations Act Series: Temporal, material and territorial scope
Client Alert | 7 min read | 10.21.26
