definiens: means ( i ) a Phase 3 Study that is intended by Bluebird ( consistent withindustry practice ) to be submitted ( together with any other registration trials that are prospectively planned when such Phase 3Study is initiated ) for Regulatory Approval of a Declined Product Candidate in the U.S. or the EU, ( ii ) a Phase / Study that isintended by Bluebird ( consistent with industry practice ) to be submitted ( together with any other registration trials that areprospectively planned when such Phase / Study is initiated ) for Regulatory Approval of a Declined Product Candidate in theU.S. or the EU, at such time when Bluebird obtains data from the Phase 2 portion of such Phase / Study and commences thePhase 3 portion of such Phase / Study, or ( iii ) any other clinical study that is designed to establish that a pharmaceuticalproduct is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that areassociated with such pharmaceutical product in the dosage range to be prescribed, which clinical study is a registration trialintended to be sufficient for filing an application for a Regulatory Approval for the Declined Product Candidate in the U.S. oranother country or some or all of an extra - national territory, as evidenced by the acceptance for filing for a RegulatoryApproval for such product after completion of such study . For purposes of this Agreement, means the date on which a final and complete clinical study report for the Declined Product CandidateStudy, based on the complete and cleaned dataset from such Declined Product Candidate Study, which dataset includes aminimum of three ( 3 ) months follow - up of all patients in such Declined Product Candidate Study, is provided to [COMPANY]