definiens: means any submission to a Regulatory Authority, including all applications, filings, submissions, approvals ( incl uding Regulatory Approvals and pricing and reimbursement approvals ), licenses, registrations, permits, notifications and authorizations ( or waivers ) with respect to the testing, research, development, manufacture or commercialization of a product made to o r received from any Regulatory Authority in a given country, together with any related correspondence and documentation submitted to or received from Regulatory Authorities ( including minutes and official contact reports relating to any communications with any Regulatory Authority ) and all supporting documents and all clinical studies and tests, relating to a product and all data contained in any of the foregoing, including any INDs and NDAs, regulatory drug lists, 15 CERTAIN CONFIDENTIAL PORTIONS OF T HIS EXHIBIT WERE OMITTED AND REPLACED WITH . A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B -2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED