definiens: means all regulatory files prepared exclusively forsubmission to an Excluded Regulatory Authority relating to the Product, including any licenses granted byan Excluded Regulatory Authority ( to the extent transferable ), and minutes of meetings and telephoneconferences with any Excluded Regulatory Authorities, validation data, preclinical and clinical studies andtests related to the Product and prepared exclusively for Excluded Regulatory Approvals including originaldata, case report forms, study files relating to the aforementioned studies and tests, and all audit reports ofclinical studies, plus all applications ( and amendments thereto ) prepared exclusively for ExcludedRegulatory Approvals, annual reports prepared exclusively for submission to an Excluded RegulatoryAuthority and safety reports associated therewith, in each case which are in Seller ’s or its Affiliates’possession or Control, and all correspondence with Excluded Regulatory Authorities regarding themarketing status of the Product ; and ( ii ) all records maintained solely for the requirements of an ExcludedRegulatory Authority under cGMPs or other record keeping or reporting requirements of ExcludedRegulatory Authorities, including all correspondence and communications with Excluded RegulatoryAuthorities in connection with the Product ( including any advertising and promotion documents ), adverseevent files, complaint files, manufacturing records in each case prepared solely for the requirements of anExcluded Regulatory Authority