definiens: means a human clinical trial of CVC conducted by or on behalf of a SellingEntity on a sufficient number of subjects that is designed to establish that a pharmaceutical product is safe andefficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associatedwith such pharmaceutical product in the dosage range to be prescribed, which clinical trial shall be intended to supportregulatory approval of CVC, as described in 21 C.F.R. 312.21(c ), or is otherwise intended to obtain authorization bythe FDA to market CVC, and which human clinical trial includes, as one of its primary outcome measures, anevaluation of improvement in fibrosis of at least one ( 1 ) stage with no worsening of steatohepatitis ( or a substantiallysimilar measure with respect to such evaluation or a similar disease characteristic ) . For clarity, such endpoint may beintended to support marketing authorization under subpart H accelerated approval, conditional approval, or any otherregulatory mechanism to license product for commercial sale in the United States . For the avoidance of doubt, noclinical trial commenced prior to the date of the date hereof shall constitute a Qualifying Phase 3 Clinical Trial