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Déjà Vu: Another FAR Rule On Contractor Codes Of Business Ethics And Conduct

Client Alert | 1 min read | 11.26.07

The Federal Register of November 23 published a final rule (http://www.crowell.com/PDF/FAR-Rule-On-Contractor-Codes_Federal-Register_11-23-07.pdf), effective December 24, which adds new features to the FAR mandating specified contractor standards of conduct (except for commercial item contracts and contracts to be performed entirely outside the United States), for new contracts expected to exceed $5 million (base plus option year value) and performance of 120 days or more (including flow down to subcontractors of the same value and performance duration). The mandated standards of conduct include (i) having a written code of business ethics and conduct; (ii) providing a copy of the code to all employees performing the contract; (iii) promoting compliance with the code; and (iv) except for small businesses, establishing an ongoing business ethics and conduct awareness program and an internal control system which facilitates timely discovery of improper conduct in connection with Government contracts and ensures prompt corrective actions (such program to include periodic reviews of company business practices, a "hotline," internal and/or external audits, and discipline for improper conduct).

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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 .  ...