definiens: means a human clinical trial of a product on asufficient number of subjects that, prior to commencement of the trial, satisfies both of thefollowing ( ( a ) and ( b ) ): ( a)such trial is designed to establish that such product has anacceptable safety and efficacy profile for its intended use, and todetermine warnings, precautions, and adverse reactions that areassociated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of suchproduct, or a similar clinical study prescribed by the U.S. or EMA ; and ( b)such trial is a registration trial designed to be sufficient to support thefiling of an application for a Regulatory Approval for such product inthe U.S. or another country or some or all of an extra - national territory, as evidenced by ( i ) an agreement with or statement from the FDA orthe EMA on a Special Protocol Assessment or equivalent, or ( ii ) otherguidance or minutes issued by the FDA or EMA, for such registrationtrial