definiens: means a human clinical trial conducted in any country that meets the requirements of 21 CFR § 312.21(b ) . By way of e xample and not limitation, a Phase 2 Clinical Trial is usually a well controlled clinical study in patients designed to assess early efficacy ( ) or to gain dose -ranging information about an investigational drug, along with product safety data . For the avoidance of doubt, a Phase 2 Clinical Trial may also represent the second part of a combined Phase lb/2 clinical study or deemed to have occurred by the initiation of a combined Phase 2/3 clinical study . In such case, the Parties will agree on the respective allocation of the later phase of such clinical trial to be outlined in BI ’s respective development plan not to be unreasonably withheld or delayed . Each Phase 2 Clinical Trial shall be deemed commenced or initiated upon dosing of the firs t participant in such trial