definiens: means a human clini cal trial of a Product on a sufficient number of subjects that, prior to commencement of the trial, satisfies both of the following : such trial ( a ) is designed to establish that such Product has an acceptable safet y and efficacy profile for its intended use, and to determine warnings, precautions, and adverse reactions that a re associated with such Product in the dosage range to be prescribed, which trial is intended to support Regu latory Approval of such Product by the FDA or EMA, and ( b ) such trial is a registration trial designed to be sufficient to support the filing of an applicati on for a Regulatory Approval for such Product in the U.S. or another country or some or all of an extra - nationa l territory, as evidenced by ( i ) an agreement with or statement from the FDA or the EMA on a special protocol asses sment or equivalent, or ( ii ) other guidance or minutes is sued by the FDA or EMA, for such registration trial