definiens: means a human clinical study that is intended to establish that a Licensed Product is safe and efficacious for its intended us e in the target population, and to determine warnin gs, precautions, and adverse reactions that are associa ted with such pharmaceutical product in the dosage range to be prescribed, which clinical trial is a registration trial intended to support Marketing Approval for su ch Licensed Product, as and to the extent defined for the Unite d States in 21 C.F.R. § 312.21(c ), or its successor regulation, or the equivalent regulation in a country other than t he United States 1.289 means, with respect to a country in the Territory, any national ( e.g., the FDA ), supra - national ( e.g., the European Commission, the Council of the Europ ean Union, or the EMA ), regional, state or local regulatory agency, departm ent, bureau, board, commission, council or other Governmental Authority that holds responsibility fo r development, commercialization or manufacturing o f, and the granting of Marketing Approval for a pharmaceut ical product in such country or region