definiens: shall mean the technical, medical and scientific licenses, registrations, authorizations and approvals ( including, without limitation, approvals ofNDAs, supplements and amendments, pre - and post - approvals, pricing and third party reimbursement approvals, and labeling approvals ) of any national, supra - national, regional, state or local regulatory agency, department, bureau, commission, councilor other governmental entity, CONFIDENTIAL TREATMENT REQUESTED PURSUANT TO 5 u.s.c . § 552 and 17 C.F.R. § § 240.12(b)(4 ), 20080 and 200.83 BY LETTER FROM MILBANK, TWEED, HADLEY & McCLOY LLP DATED MARCH 28,2002 ----- .. _ ------15 -CONFIDENTIAL TREATMENT REQUESTED necessary for the development ( including the conduct of clinical trials ), manufacture, distribution, marketing, promotion, offer for sale, use, import, export or sale of Collaboration Product(s ) in a regulatory jurisdiction