definiens: means ( a ) a Phase 3 Clinical Trial or, ( b ) a Phase 2 Clinical Trial to the extent : ( i)in the United States, the protocol for that Phase 2 Clinical Trial shall have been reviewed by the FDA under its currentSpecial Protocol Assessment Guidelines ( or equivalent guidelines issued in the future ), and any comments from the FDA onthat protocol are incorporated in the final protocol for that Phase 2 Clinical Trial or are resolved to the FDA ’s satisfaction asevidenced by further written communications from the FDA ; or ( ii ) a process with a comparable result – acceptance of aPhase 2 Clinical Trial protocol as – has occurred with the EMA / CHMP in the European Union ; or ( iii)based on the results of that Phase 2 Clinical Trial, either the FDA or the EMA has determined that the Phase 2 Clinical Trialcan be considered as a pivotal clinical trial for purposes of obtaining Marketing Authorization