definiens: means a human clinical trial conducted in any country that meets the requirements of 21 CFR § 312.21(c ) . By way of example and not limitation, a Phase 3 Clinical Trial is a large scale clinical study ( usually several hundreds of patients ) performed after preliminary evidence suggesting effectiveness of the drug has been obtained in Phase 2 clinical studies, and it is intended to gather the pivotal information about effectiveness and safety that i s needed to evaluate the overall benefit -risk relationship of the drug and, along with other clinical trials, to provide an adequate basis for Regulatory Approval . For the avoidance of doubt, a Phase 3 Clinical Trial may also represent the second part of a combined Phase 2/3 clinical study or a pivotal trial . In such case, the Parties will agree on the respective allocation of the combined Phase 2/3 or pivotal trial to be outlined in BI ’s respective development plan not to be unreasonably withheld or delaye d, provided that in no event will this period be longer than the first filing for marketing authorization for an applicable product . Each Phase 3 Clinical Trial shall be deemed commenced or initiated upon dosing of the first participant in such trial