definiens: means a Clinical Trial of a Licensed Product on a sufficient number of subjects that, prior to commencement of such Clinic al Trial : ( a ) is designed to establish that such Li censed Product has an acceptable safety and efficacy profi le for its intended use, and to determine warnings, precautions, and adverse reactions that are associa ted with such Licensed Product in the dosage range to be prescribed, which trial is intended to support Regu latory Approval of such Licensed Product, or a simi lar clinical study prescribed by the applicable Regulatory Autho rity ; and ( b ) is a registration trial sufficient fo r filing an application for a Regulatory Approval for such Lice nsed Product, as evidenced by : ( i ) an agreement wit h or statement from the applicable Regulatory Authority on a special protocol assessment or its equivalent, or ( ii ) other guidance or minutes issued by the applic able Regulatory Authority for such registration tri al . For clarity, a Phase 3 Clinical Trial is a Pivotal Clin ical Trial