definiens: means any submission to a Regulatory Authority, including all applications, filings, submissions, approvals ( including Regulatory Approvals and Pricing and Reimbursement Approvals ), licenses, registrations, permits, notifications and authorizations ( or waivers ) with respect to the testing, Development orCommercialization of a product made to or received from any Regulatory Authority in a given country together withany related correspondence and documentation submitted to or received from Regulatory Authorities ( includingminutes and official contact reports relating to any communications with any Regulatory Authority, but excluding anyDMF ( except as contained in the CMC section of any such submission ) ) and all supporting documents and all clinicalstudies and tests, relating to a product and all data contained in any of the foregoing, including any INDs and NDAs, regulatory drug lists, advertising and promotion documents, clinical data, adverse event files and complaint files, andinclude any submission to a regulatory advisory board, marketing authorization application, and any supplement oramendment thereto