definiens: shall mean ( a ) a Phase 3 Trial, or ( b ) any other Clin ical Trial that the applicable RegulatoryAuthority has agreed, whether before ﬁrst dosing of the ﬁr st patient in such trial ( e.g., pursuant to an agreemen t with orstatement from the FDA or the EMA on a or equivalent or other guidance or minutes issuedby the FDA or EMA ) or after ﬁrst dosing of the ﬁrst patient in such trial ( e.g., based on an interim data analysis ), is suﬃcientto form the primary basis of an eﬃcacy claim in a Marketing Approval Application, regardless of whether the sponsor of suchtrial characterizes or refers to such trial as a or trial ( or otherwise ) in the ap plicableprotocol, on clinicaltrials.gov, or in any other context . I f a Clinical Trial does not constitute a Pivotal Trial at the time of dosingof the ﬁrst subject in such Clinical Trial, but is later de termined by the applicable Regulatory Authority to be suﬃ cient to formthe primary basis of an eﬃcacy claim in a Marketing Approval Application, then, for purposes of Section 6.4 hereof, of such Clinical Trial shall be deemed to have occurred on the date of such determination by the app licableRegulatory Authority