Investigational Drug (Non-Emergency) Expanded Access Contract (Single-Patient, Company-friendly)

This legal template is designed to outline the terms and conditions for a single-patient expanded access program related to an investigational drug (non-emergency) in the United States, as per USA law. Expanded access refers to a situation where a patient, outside of a clinical trial, is granted access to an investigational drug that is not yet approved by the regulatory authorities. This contract favors the interests of the pharmaceutical company while ensuring compliance with relevant legal and regulatory obligations. It covers aspects such as the patient's eligibility criteria, informed consent, details of the investigational drug, potential risks and benefits, patient confidentiality, legal liability, financial considerations, and termination clauses. The template aims to establish a legal framework that allows the pharmaceutical company to provide the investigational drug to a specific patient while mitigating potential legal risks and ensuring compliance with applicable regulations surrounding expanded access programs.