definiens: means a human clinical tr ial of a product in any country that satisfies both of the following ( ( a ) and ( b ) ): ( a ) such trial includes a sufficient number of s ubjects and is designed to establish that such product has an acceptable safety and efficacy profi le 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, whic h trial is intended to support Regulatory Approval of such pro duct, or a similar human clinical trial prescribed 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 prod uct in an applicable country or jurisdiction or som e or all of an extra - national territory, as evidenced by ( i ) an agreement with or statement from an applicable Reg ulatory Authority, or ( ii ) other guidance or minutes issued by an applicable Regulatory Authority, for such re gistration trial