definiens: means a human clinical trial of a product on a sufficient number of subj ects that satisfies both of the following ( ( a ) and ( b ) ): ( a ) such trial is designed to establish ( with one or more other Pivotal Clinical Trials, if applicable ) that such product has an acceptable safety and efficacy profile for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, or a similar clinical study prescribed by the NMPA, FDA, EMA or other applicable Regulatory Authority ; and - 14 - ( b ) such trial is a registration trial designed to be sufficient ( with one or more other Pivotal Clinical Trials, if applicable ) to support the filing of an application for a Regulatory Approval for such product in China, the U.S. or another country or some or all of an extra -national territory, as evidenced by ( i ) an agreement with or statement from the NMPA, FDA, EMA or other applicable Regulatory Authority on a Special Protocol Assessment or equivalent, or ( ii ) other guidance or minutes issued by the NMPA, FDA, EMA or other applicable Regulatory Authority, for such registration trial