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New Pro-Competitive Restrictions On DoD Prototype Line Items and Options

Client Alert | 1 min read | 06.18.10

On June 8, 2010, DoD issued an interim rule, intended to prevent competitively awarded contracts for new technology from becoming noncompetitive efforts long-term. The interim DFARS provisions require that contract line item purchases and contract options must be limited to the minimum number of initial or additional prototype items that will allow for timely competitive solicitation and award of a follow-on development or production contract for those items; that the term of the contract line item or contract option cannot be longer than 12 months; and that the dollar value of the work to be performed pursuant to the contract line item or contract option may not exceed three times the dollar value of the work previously performed under the contract or $20 million, whichever is less.

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 .  ...