definiens: means [ * * * ] 1.31 means ( a ) a Phase 3 Study that is intended by [COMPANY] to besubmitted ( together with any other registration trials that are prospectively planned when suchPhase 3 Study is initiated ) for Regulatory Approval in the U.S. or the EU, or ( b ) any other clinicalstudy that is designed to establish that a pharmaceutical product is safe and efficacious for itsintended use, and to determine warnings, precautions, and adverse reactions that are associatedwith such pharmaceutical product in the dosage range to be prescribed, which clinical study is aregistration trial intended to be sufficient for filing an application for a Regulatory Approval for theLicensed Product in the U.S. or another country or some or all of an extra - national territory, solelyas evidenced by the acceptance for filing for a Regulatory Approval for such product aftercompletion of such study