definiens: means the first dosing of the Product in a human patient in human clinical trial of the Product on a sufficient number of subjects that is designed to establish that a pharmaceutical 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 Approval of the Product, as described in 21 C.F.R. 312.21(c ) for the United States, or a similar clinical study prescribed by the applicable Governmental Entity in a foreign country . For purposes of this Agreement, in the case where a Phase lIb / III Clinical Trial precedes any Phase III Clinical Trial for the Product, the first dosing of the Product in a human patient following the review of interim data and decision to extend the period of such Phase lIb / III Clinical Trial in order to provide sufficient evidence of safety and efficacy to be included as a Phase III Clinical Trial in filings with the applicable Governmental Entity shall be deemed to be the for the Product