definiens: . ' [ IAt Tl ~ I'.\T\[EPhase 3 Trial " means a clinical trial in hUn1iln patients designed to ( a ) e ~ lablish that a drug is safe and efficacious for its intended use ; ( b ) define warnings, pl'eullltions and adverse re8.ctions that 8.1'e associated with the drug in the dosage rangc to be pn : scribed ; and ( c ) SLlPPOli BLA Approval of slieh drug . as more fully defined in 21 C.F.R. § 312.21(c ), or its successor regulation, or the equivalent in any foreign eountl ' } ', 1.55 means ( a ) Phase 3 Tri8.l 01 " ( b ) II Phase 2 rrial that is oC appropriate size and design to establish that a phannaceulical product is safe and effective tal ' its intended use, to define INarnings, precautions and adverse reactions that are associakd \\ith the phalOduct in the dosage range to be prcscribed, and to support a HLA for ~lIch pharmaccutical product or label expansion of such pharmaceutical product . For clarity, the determination of whether a Phast ! 2 Trial is a Pivotal TI'ial f'ol " purposes of this Agreement will be based upon a determination by the relevant Regulatol'y Authority that such trial could he sufficient, depending on its outcome, to SllppOli the filing of a BLA for such pharmaceutical product or label expansion of slich pharmaceutical pl - oduct