definiens: means ( a ) a Phase 3 Trial, or ( b ) a human clinica l trial of a Product that satisfies the requirements of 21 C.F.R. § 312.21(c ) and is a regi stration trial designed to establish statistically significant efficacy and safety of such Product for the purpose of enabling the preparation and submission of appl ication for an NDA, MAA, JNDA or similar application for market ing approval to the competent Regulatory Authoritie s in a given country, as evidenced by ( i ) an agreement wit h or statement from the FDA on a Special Protocol A ssessment or equivalent in another country or ( ii ) other guid ance or minutes issued by the FDA, for such registr ation trial or equivalent in another country, or ( iii ) [COMPANY] ’s pu blic statements, with respect to each, where the re sults of such clinical trial are intended ( if supportive ) to be u sed to establish both safety and efficacy of such P roduct in patients that are the subject of such trial and serve as the basis for obtaining initial or supplemental Regula tory Approval in the United States of such Product . For clarity, any compassionate use dosing with respect to a Prod uct shall not be considered the Initiation of a Pivotal Clinical Trial with respect to such Product