definiens: means a human clinical trial conducted in any country that meets the requirements of 21 CFR § 312.21(a ) . By way of example and not limitation, a Phase 1 Clinical Trial is usually performed as a single or multiple dose clinical study in healthy volunteers or patients to assess specific administration, distribution, metabolism, excretion ( ADME ), safety and tolerability, bioavailability / bioequivalence or exploratory efficacy ( in the sense of demonstrating ) of an investigational drug, and the emphasis in Phase 1 is usually on safety and tolerability and it is typically used to plan patient dosing in Phase 2 clinical studies . For the avoidance of doubt, a Phase I Clinical Trial will be deemed to have occurred by the initiation of a combined Phase lb/2 clinical study . In such case, the Parties will agree on the respective allocation of initial and subsequent phase of such clinical trial to be outlined in BI ’s respective development plan, not to be unreasonably withheld or delayed . Each Phase 1 Clinical Trial shall be deemed commenced or initiated upon dosing of the first participant in such trial