definiens: means a clinical trial of a Product in human patients, which trial is designed ( a ) toestablish that the Product is safe and efficacious for its intended use ; ( b ) to define warnings, precautions and adversereactions that are associated with the Product in the dosage range to be prescribed ; ( c ) to be, either by itself ortogether with one or more other clinical trials having a comparable design and size, the final human clinical trial insupport of Regulatory Approval of the Product and ( d ) consistent with 21 CFR § 312.21(c ) ( as hereafter modified oramended ) and any of its foreign equivalents . For the avoidance of doubt, it is the 8 CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH . ACOMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THESECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIALTREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, ASAMENDED