Significant Changes on the Horizon to the Limitations on Subcontracting
Client Alert | less than 1 min read | 01.14.15
On December 29, 2014, the Small Business Administration issued long overdue proposed amendments to its regulations (with 60 days for comments) to implement many of the provisions of the National Defense Authorization Act of 2013, most notably with a complete overhaul of the calculation of the limitations on subcontracting. Additional proposed revisions include: greater specificity to the identity of interest affiliation test; exemptions from affiliation for small business joint venture members and "similarly situated" subcontractors; a new recertification requirement for mergers/acquisitions occurring after proposal submission but prior to award; changes to the nonmanufacturer rule; and a new reporting mechanism and expanded sanctions related to subcontracting plan 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
