definiens: means either ( a ) a Clinical Trial, the principal purpose of which is to demonstrate clinically and statistically the effica cy and safety of a Licensed Product as a basis for obtaining Regulatory Approval, and has been recognized and approved as such by the Regulatory Authority, or ( b ) a Clinical Trial of a Licensed Product on a sufficient number of subjects that satisfies both of the following ( i ) and ( ii ): ( i ) such trial is designed to establish that such Licensed P roduct has an acceptable safety and efficacy profil e for its intended use, and to determine warnings, precaution s, and adverse reactions that are associated with s uch Licensed Product, which trial is intended to suppor t Regulatory Approval of such Licensed Product ; and ( ii ) such trial is a registration trial intended to be sufficient to support the filing of an applicat ion for Regulatory Approval for such Licensed Product in th e US, or applicable country, as evidenced by ( A ) an agreement with or statement from the FDA or its for eign equivalent, or ( B ) other guidance or minutes issued by the FDA or its foreign equivalent, for su ch registration trial