definiens: means a clinical trial of a product on a sufficient number of subjects that is designed to establishthat a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions, and adversereactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which trial is intended tosupport Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c ) ( as amended or any replacement thereof ), ora similar clinical study prescribed by the Regulatory Authorities in a foreign country . For purposes of this Agreement and theDevelopment & Commercialization Agreements, ( i ) for a product means ( a ) the first dosingof such product in a human patient in a Phase 3 Study, or ( b ) the date on which the sponsor elects to continue enrollment ofpatients in a Phase / Study following an interim analysis of safety and efficacy data generated from the initial patentsenrolled in such Phase / Study, and ( ii ) means the final dosing of the last patient to be dosedin such Phase 3 Study