definiens: means a human clinical trial of a Product ( whether a standalone trial or astage of a clinical trial described in the protocol as the ): ( a ) ( 1 ) with a deﬁned dose or a set ofdeﬁned doses of such Product designed to establish statistically signiﬁcant eﬃcacy and safety of such Product for thepurpose of enabling the preparation and submission of an NDA to the competent Regulatory Authorities in a country of theTerritory, or ( 2 ) where the results of such clinical trial are intended ( if successful ) to be used to establish both safety andeﬃcacy of such Product in patients which are the subject of such trial and serve as the basis for initial or supplementalMarketing Approval of such Product, and ( b ) that satisﬁes the requirements of 21 CFR § 312.21(c ) or its non - U.S