definiens: shall mean : ( a ) a human clinical trial that would satisfy the requirements for a Phase 3 study as defined in 21 CFR § 312.21(c ) ( or any amended or successor regulations ) ; or ( b ) any other human clinical trial that the applicable Regulatory Authority has agreed, whether before first dosing of the first patient in such trial ( e.g., pursuant to a special protocol assessment agreement with the FDA ) or after first dosing of the first patient in such trial ( e.g., based on an interim data analysis ), is sufficien t 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 other context . If a human clinical trial does * * * Certain Confidential Information Omitted 12 Confidential not constitute a Pivotal Trial at the time of first dosing of the first patient in such trial, but is later dete rmined by the applicable Regulatory Authority to be sufficient to form the primary basis of an efficacy claim in an NDA submission, then, for purposes of Section 10.2(a ) hereof, of such Pivotal Trial shall be deemed to have occurred on the dat e of such determination by the applicable Regulatory Authority