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Industrial Base Sole-Source Award Deficient

Client Alert | less than 1 min read | 04.04.14

In Coulson Aviation (USA) Inc.; 10 Tanker Air Carrier, LLC; Minden Air Corp. (Mar. 31, 2014), GAO agreed with protesters, including one represented by Crowell & Moring, that the U.S. Forest Service had unlawfully awarded a sole-source contract with a potential value of nearly $500 million. After extensive briefing and a two-day hearing, GAO found that the sole-source award was invalid because the true basis for award had been honoring a settlement agreement promise to award the contract and the Justification & Approval supporting the award both (i) improperly relied on the factually inapplicable "industrial base" exception to the full and open competition requirements of the Competition in Contracting Act and (ii) failed to identify the critical facts relevant to the award.


Insights

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 .  ...