definiens: means a clinical trial of a product that satisfies both of the following ( ( a ) and ( b ) ): ( a ) such trial includes a sufficient number of subjects and is designed to establish that such product has an acceptable safety and efficacy profile for its intended use, and to determine warnings, precautions and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, or a similar clinical study pres cribed by an applicable Regulatory Authority ; and ( b ) such trial is a registration trial designed to be sufficient to support the filing of an application for a Regulatory Approval for such product in an applicable country or jurisdiction or some or all o f an extra -national territory, as evidenced by ( i ) an agreement with or statement from an applicable Regulatory Authority, or ( ii ) other guidance or minutes issued by an applicable Regulatory Authority, for such registration trial