definiens: means [ * * * ] 1.30 means ( i ) a Phase 3 Study that is intended by [COMPANY] to be submitted ( together with any otherregistration trials that are prospectively planned when such Phase 3 Study is initiated ) for Regulatory Approval in the U.S. orthe EU, or ( ii ) any other clinical study 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 associated with such pharmaceuticalproduct in the dosage range to be prescribed, which clinical study is a registration trial intended to be sufficient for filing anapplication for a Regulatory Approval for the Licensed Product in the U.S. or another country or some or all of an extra - national territory, solely as evidenced by the acceptance for filing for a Regulatory Approval for such product aftercompletion of such study