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DFARS Excessive Pass-Through Cost Rule Modified

Client Alert | 1 min read | 05.13.08

Effective May 13, 2008 (73 Fed. Reg. 27464), the widely-criticized interim DFARS rules about "excessive pass-through costs" published last April were modified in yet another interim rule to address the confusion created by the interim rules. The most important features of the new interim rules are in the prefatory comments, which emphasize repeatedly that the requirement for reporting when subcontract effort will exceed 70 percent applies both before and after award, but is only a reporting requirement, not a threshold for coverage, and that the rules do not apply to any contract, no matter what the subcontract content, where the contractor demonstrates "added value," a term that is defined in the interim regulations to include performance of "subcontract management functions that the Contracting Officer determines are a benefit to the Government (e.g., processing orders of parts or services, maintaining inventory, reducing delivery lead times, managing multiple sources for contract requirements, coordinating deliveries, performing quality assurance functions)."

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Client Alert | 9 min read | 10.21.26

Artificial Intelligence in Life Sciences: Reliability of AI-Generated Evidence in Drug Discovery and Development

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 .  ...