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Helping Us Help You: DDTC Modernizes ITAR Exemption for Contractor’s Supporting Government Agencies

Client Alert | 1 min read | 04.22.19

On April 19, 2019, nearly four years after the initial proposal, DDTC issued a final rule modifying § 126.4 of the International Traffic in Arms (ITAR) to clarify and expand the exemption authorizing exports in support of the US Government, including US foreign assistance and cooperative programs. Most significantly, the revised exemption acknowledges the government’s expanded use of contractor personnel in supporting USG missions often involving foreign parties. The exemption now expressly covers defense services and other exports by “persons or entities in a contractual relationship with the U.S. Government” where use of the defense article or performance of the defense service is within the scope of such contract and where any one of three specified conditions exist and assure government control and oversight of the transfer.

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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 .  ...