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Stick to the Plan!: Anticipated March 2013 SBA Final Rule

Client Alert | 1 min read | 01.14.13

On January 8, the SBA disclosed its plan to issue a final rule in March to implement several requirements of the Small Business Jobs Act of 2010 (Pub. L. No. 111-240) related to "covered contracts" for which a small business subcontracting plan is required (currently, construction contracts in excess of $1.5 million or other contracts exceeding $650,000). The rule, which has undergone two comment periods (76 Fed. Reg. 61626 and 76 Fed. Reg. 74749), is intended to allow the funding agency to monitor a prime's small business subcontracting more closely and to encourage it to meet its subcontracting plan through regulation to include: a requirement that the prime represent that it will make good faith efforts to award subcontracts to small businesses at the same percentage as indicated in its plan and, if the percentage is not met, a written justification and explanation to the CO for the failure; a requirement that the prime notify the CO if it pays a reduced price to a subcontractor; and the ability for the funding agency to establish goals at the individual order level for multi-agency, FSS, MAS, and IDIQ contracts.


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 .  ...