definiens: means a human clinical trial of a compound on a sufficient number of subjects that satisfiesboth of the following ( ( a ) and(b)):(a ) such trial is designed to establish that such compound has an acceptable safety and efficacy profile for itsintended use, and to determine warnings, precautions, and adverse reactions that are associated with such compound in thedosage range to be prescribed, which trial is intended to support Regulatory Approval of such compound, or a similar clinicalstudy prescribed by the EMA or another Regulatory Authority ; and(b ) either ( i ) such trial is a Phase 3 Clinical Trial that is intended by the JDC to be submitted ( together withany other registration trials that are prospectively planned when such Phase 3 Clinical Trial is Initiated ) for centralizedRegulatory Approval to the EMA for the EU or for Regulatory Approval by the applicable Regulatory Authority in any of theMajor EU Countries, or ( ii ) such trial is a registration trial intended to be sufficient for filing an application for a RegulatoryApproval for such compound in the United States or another country or some or all of an extra - national territory, solely asevidenced by the acceptance for filing for a Regulatory Approval for such compound after completion of such trial