definiens: means a clinical trial of a product on a sufficient number of subjects that is designed to establish that a phannaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.P.R. 312.21(c ) ( as amended or any replacement thereof ), or a similar clinical study prescribed by the Regulatory Authorities in a foreign country . Por purposes of this Agreement and the Development & Commercialization Agreements, ( a ) for a product means ( I ) the first dosing of such product in a human patient in a Phase 3 Study, or ( ii ) the date on which the sponsor elects to continue enrollment of patients in a Phase 2/3 Study following an interim analysis of safety and efficacy data generated from the initial patents enrolled in such Phase 2/3 Study, and ( b ) means the final dosing of the last patient to be dosed in such Phase 3 Study