definiens: means a human cli nical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(c ) and is inte nded to ( a ) establish that the product is safe and efficacious for its intended use, ( b ) define contraindications, warnings, precautions and adverse reactions that a re associated with the product in the dosage range to be prescrib ed, and ( c ) support Regulatory Approval for such pr oduct ; or a similar clinical study prescribed by the relevant R egulatory Authorities in a country other than the U nited States ; it being understood and agreed that any clinical tr ial is a Phase 3 Clinical Trial if such trial is a registration trial sufficient for filing an application for a Regulato ry Approval for such product in the United States o r another country or some or all of an extra - national territo ry, as evidenced by the acceptance of filing for a Regulatory Approval by the applicable Regulatory Authority for such product after the completion of such trial