definiens: means ( a ) a Phase 3 Trial, or ( b ) a human clinica l trial of a Licensed Product that satisfies the requirements of 21 C.F.R. § 312 . 21(c ) and is a registration trial designed to estab lish statistically significant efficacy and safety of such Licensed Pr oduct for the purpose of enabling the preparation a nd submission of application for Regulatory Approval t o the competent Regulatory Authorities in a given c ountry, as evidenced by ( i ) an agreement with or statement from the FDA on a Special Protocol Assessment or equivalent in another country or ( ii ) other guidanc e or minutes issued by the FDA, for such registrati on trial or equivalent in another country, or ( iii ) a Party ’s p ublic statements, with respect to each, where the r esults of such clinical trial are intended ( if supportive ) to be u sed to establish both safety and efficacy of such L icensed Product in patients that are the subject of such trial and serve as the basis for obtaining initial or supplem ental Regulatory Approval in the United States of such Licensed Prod uct . For clarity, any compassionate use dosing with respect to a Licensed Product shall not be considered the i nitiation of a Pivotal Clinical Trial with respect to such Licensed Product