definiens: means a Phase 2 Clinical Study involving a suffic ient number of subjects that, prior to commencement of the trial o r at any other defined point in the trial, satisfie s both of the following ( ( a ) and ( b ) ): -12- ( a ) such trial is intended to ( i ) establish that th e Product is safe and efficacious for its intended use, and ( ii ) generate such data a s is necessary to define and determine warnings, precautions, and adverse reactions that are associa ted with the Product in the dosage range to be prescribed, which trial is intended to support Mark eting Approval of such Product or a similar clinica l study prescribed by the Regulatory Authority in the applicable country or jurisdiction ; and ( b ) such trial is or becomes a registration trial s ufficient for filing a Drug Approval Application for such Product in the applic able country or jurisdiction, as evidenced by ( i ) a n agreement with or statement from the Regulatory Aut hority in such country or jurisdiction, or ( ii ) oth er guidance or minutes issued by the Regulatory Author ity in such country or jurisdiction, for such registration trial