definiens: shall mean : ( a ) a Phase 3 Clinical Trial ; or ( b ) any other human clinical trial that the applicable Regulator y Authority has agreed, whether before Initiation of such trial ( e.g., pursuant to a special protocol assessment agreement with the FDA ) or after Initiation of such trial ( e.g., based on an interim data analysis ), is sufficient to form the primary basis of an efficacy claim in an NDA submission, regardless of whether the sponsor of such trial characterizes or refers to such trial as a or trial ( or otherwise ) in the applicable protocol, on clinicaltrials.gov, or in any othe r context . If a human clinical trial does not constitute a Pivotal Trial at the time of Initiation of such trial, but is later determined by the applicable Regulatory Authority to be sufficient to form the primary basis of an efficacy claim in an NDA submi ssion, then, for purposes of Section 4.2 hereof, and notwithstanding Section 1.42, of such Pivotal Trial shall be deemed to have occurred on the date of such determination by the applicable Regulatory Authority