definiens: means : ( a ) a Phase 3 Trial ; 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 sufficient to form the primary basis of an efficacy claim in an MAA submission, regardless of whether the sponsor of s uch 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 not constitute a Pivotal Trial at the time of first dosing of the first patient in 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 MAA submission, then, for purposes of Section 8.2 ( Regulatory Mil estone Payments ) hereof, and notwithstanding Section 1.40 ( Initiation ) hereof, of such Pivotal Trial shall be deemed to have occurred on the date of such determination by the applicable Regulatory Authority