definiens: shall mean, with respect to a given product and given country, any and all approvals, licenses, registrations or authorizations of any Regulatory31 [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES ANDEXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.CONFIDENTIAL TREATMENT REQUESTEDUNDER 17 C.F.R. § § 200.80(b)(4 ) AND 240.24B-2Authority necessary to develop or commercialize such product in such country, including, where applicable, pre- and post - marketingauthorizations ( including Marketing Approvals ), labeling approvals and technical, medical and scientific licenses, but excluding pricingand reimbursement approvals