definiens: shall mean all files, documents, instruments, papers, books and records Controlled by Seller and / orany of its Affiliates, whether in electronic or tangible form, that relate primarily to the Product, the Product Business and / orthe Product Intellectual Property, including, without limitation, any and all pricing lists, customer lists, vendor lists, financialdata, research and development files, marketing materials, regulatory files, adverse event reports and files ; equipmentspecifications ; analytical specifications and validation reports ; Product batch records ; bills of material ; packagingspecifications ; approved and rejected vendor lists and audits ; Product complaints, clinical studies and all documentationrelating thereto ; all 9documentation associated with the Product Intellectual Property ; copies of all filings ( and supporting documentation ) withGovernmental Authorities, including, but not limited to, any and all Product NDAs and BLAs ; component and labelingpurchasing specifications ; packaging and quality control SOPs ; stability data, records, charts, reports and applicable SOPs;quality assurance / control data, records, charts, reports, and applicable SOPs ; budgets ; pricing guidelines ; ledgers ; journals;Assumed Contracts ; Promotional Materials ; operating data and plans ; sales data ; target lists ; file histories, file wrappers, correspondence, application documents, registration documents, search reports, documents concerning the prosecutionhistory, enforcement or maintenance of rights, or restrictions on use, with respect to the Product Intellectual Property, whetheror not required to be kept or maintained under any Law ; but excluding ( i ) the Excluded Data and Materials and ( ii ) any itemsto the extent that any Applicable Law prohibits their transfer