definiens: means a human clinical trial of a compound on a sufficient number of subjects thatsatisfies both of the following ( ( a ) and(b)):(a ) such trial is designed to establish that such compound has an acceptable safety and efficacyprofile for its intended use, and to determine warnings, precautions, and adverse reactions that are associated withsuch compound in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of suchcompound, or a similar clinical study 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 ( togetherwith any other registration trials that are prospectively planned when such Phase 3 Clinical Trial is Initiated ) forcentralized Regulatory Approval to the EMA for the EU or for Regulatory Approval by the applicable RegulatoryAuthority in any of the Major EU Countries, or ( ii ) such trial is a registration trial intended to be sufficient for filing anapplication for a Regulatory Approval for such compound in the United States or another country or some or all of anextra - national territory, solely as evidenced by the acceptance for filing for a Regulatory Approval for such compoundafter completion of such trial