definiens: means the United States New Drug Applications and Investigational New Drug applications listed in Schedule 1.52 and all other submissions, supplements or amendmen ts as of the Closing Date pertaining -10- thereto . The term includes t he materials contained in the official Marketed Product NDA files, including all Marketed Product N DA submissions, amendments, supplements, correspondence ( including correspondence with the F DA field offices, FDA laboratories, FDA compliance offices and DDMAC ), reports and memoranda of teleph one conversations, constituting or reflecting communications between [COMPANY] and the FDA regarding the Marketing Product NDA . The term also include s such materials in the working regulatory and clin ical files of [COMPANY] pertaining to the conduct of upcoming annual reviews of the Marke ted Product and required reports to the FDA that ha ve yet to be filed, but not primary sources such as la boratory notebo oks or historical records not relevant to the maintenance of regulatory filings relating to the M arketed Products . For avoidance of doubt, any marke ting authorizations or any other submissions, supplement s or amendments, files or data pertaining solely to jurisdictions outside the Territory are not include d in the Marketed Product NDAs