definiens: means either ( a ) a human clinical trial, the principal purpose of which is to demonstrate clinically and statistically the efficacy and safety of a Licensed Product for one or more Indications in order to obtain Marketing Approval of such Licensed Product for such Indication(s ), as further defined in 21 C.F.R. § 312.21 or ( b ) a human cl inical trial of a product on a sufficient number of subjects that, prior to commencement of the trial, satisfies both of the following ( ( i ) and ( ii ) ): ( i ) such trial is designed to establish that a Licensed Product has an acceptable safety and efficacy pro file for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such Licensed Product in the dosage range to be prescribed, which trial is intended to support Marketing Approval of such product ; and ( ii ) such trial is a registration trial sufficient to support the filing of Marketing Approval Application for such Licensed Product in the U.S., Japan, or a Major European Market, as evidenced by ( A ) an agreement with or statement from the FDA or the EMA on a ‘S pecial Protocol Assessment ’ or equivalent, or ( B ) other guidance or minutes issued by the FDA or EMA, for such registration trial