definiens: means any clinical study conducted on human subjects with primary endpoints toestablish that a pharmaceutical product is reasonably safe for continued testing and to support its continued testing inPhase 2 Clinical Trials . shall include any clinical trial that would satisfy requirements of 21C.F.R. § 312.21(a ) . Phase 1 Clinical Trials shall include without limitation those trials designated as or means any clinical study that is not intended to be used as a pivotal study for purposesof seeking Regulatory Approval in a Major Country and that is conducted on human patients who have the relevantdisease or condition with primary endpoints to establish the efficacy of a Licensed Product for its intended use and todefine warnings, precautions, and adverse reactions that may be associated with the pharmaceutical product in thedosage range to be prescribed . shall include without limitation any clinical trial that wouldsatisfy requirements of 21 C.F.R. § 312.21(b )