definiens: means a Clinical Trial of a product on a suﬃcient number of subjects that, prior tocommencement of the trial, satisfies both of the following ( ( a ) and ( b)):(a)such trial is designed to establish that such product has an acceptable safety and eﬃcacy proﬁle for itsintended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in thedosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, or a similar clinicalstudy prescribed by the FDA, EMA or other applicable Regulatory Authority ; and(b)such trial is a registration trial suﬃcient for ﬁling an application for a Regulatory Approval for suchproduct in the U.S. or another country or some or all of an extra - national territory, as evidenced by ( i ) an agreement with orstatement from the FDA, the EMA or other applicable Regulatory Authority on a Special Protocol Assessment or equivalent, or ( ii ) other guidance or minutes issued by the FDA, EMA or other applicable Regulatory Authority, for such registration trial