definiens: means either ( a ) a Clinical Trial the principal purposeof which is to demonstrate clinically and statistically the efficacy and safety of a LicensedProduct for one or more Indications in order to obtain Regulatory Approval of such LicensedProduct for such Indication(s ), as further defined in 21 C.F.R. § 312.21 or ( b ) a Clinical Trial ofa Licensed Product on a sufficient number of subjects that, prior to commencement of suchtrial, satisfies both of the following ( ( i ) and ( ii ) ): ( i ) such trial is designed to establish that suchLicensed Product has an acceptable safety and efficacy profile for its intended use, and todetermine warnings, precautions, and adverse reactions that are associated with suchLicensed Product in the dosage range to be prescribed, which trial is intended to supportRegulatory Approval of such Licensed Product ; and ( ii ) such trial is a registration trialsufficient to support the filing of a Drug Approval Application for such Licensed Product in theU.S., Japan, or a European Major Market, as evidenced by ( A ) an agreement with orstatement from the FDA or the EMA on a ‘ Special Protocol Assessment ’ or equivalent, or ( B)other guidance or minutes issued by the FDA or EMA, for such registration trial