definiens: shall mean all files, documents, instruments, papers, Books and Records Controlled by Seller and/or any of itsAffiliates, whether in electronic or tangible form, that relate primarily to the Products, the Product Business and/or the ProductIntellectual Property, including any and all pricing lists, customer lists, vendor lists, financial data, research and developmentfiles, marketing materials, regulatory files, adverse event reports and files ; equipment specifications ; analytical specifications andvalidation reports ; Product batch records ; bills of material ; packaging specifications ; approved and rejected vendor lists andaudits ; Product complaints, clinical studies and all documentation relating thereto ; all documentation associated with theProduct Intellectual Property ; copies of all filings ( and supporting documentation ) with Governmental Authorities ; regulatoryand other opinions and memoranda, component and labeling purchasing specifications ; packaging and quality control SOPs;stability data, records, charts, reports and applicable SOPs ; quality assurance / control data, records, charts, reports, and applicableSOPs ; budgets ; pricing guidelines ; ledgers ; journals ; Assumed Contracts ; Promotional Materials ; Medical Information ; operatingdata and plans ; sales data ; target lists ; file histories, file wrappers, correspondence, application documents, registrationdocuments, search reports, documents concerning the prosecution history, enforcement or maintenance of rights, or restrictionson use, with respect to the Product Intellectual Property, freedom - to - operate and other patent opinions and related documentsrelating to Third Party IP Rights, whether or not required to be kept or maintained under any Applicable Law ; but excluding anyitems to the extent that any Applicable Law prohibits their transfer