definiens: means a human clinical trial of a Product in the Field, the principalpurpose of which is to gather safety and efficacy data of one or more particular doses in patientsbeing studied that is needed to evaluate the overall benefit and risk relationship of the Product andto provide adequate basis for labeling, as more fully defined in 21 C.F.R. § 312(c ) or comparableregulations in any country or jurisdiction outside the U.S. ( and any amended or successorregulations).Exhibit C-7 [ * * * ] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HASBEEN REQUESTED . ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES ANDEXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGEACT OF 1934, AS AMENDED 1.44