definiens: shall mean all files, documents, instruments, papers, books and records Controlled b y Seller and/or any of its Affiliates, whether in ele ctronic or tangible form, that relate primarily to the Product, the Product Business and/or the Product Intellectual Pr operty, including, without limitation, any and all pricing lists, customer lists, vendor lists, financial data, resea rch and development files, marketing materials, reg ulatory files, adverse event reports and files ; equipment specific ations ; analytical specifications and validation re ports ; Product batch records ; bills of material ; packaging specifications ; approved and rejected vendor lists and audits ; Product complaints, clinical studies and all docume ntation relating thereto ; all 9 documentation associated with the Product Intellect ual Property ; copies of all filings ( and supporting documentation ) with Governmental Authorities, inclu ding, but not limited to, any and all Product NDAs and BLAs ; component and labeling purchasing specificati ons ; packaging and quality control SOPs ; stability data, records, charts, reports and applicable SOPs ; quali ty assurance / control data, records, charts, reports, and applicable SOPs ; budgets ; pricing guidelines ; ledge rs ; journals ; Assumed Contracts ; Promotional Materi als ; operating data and plans ; sales data ; target lists ; file histories, file wrappers, correspondence, app lication documents, registration documents, search reports, documents concerning the prosecution history, enfor cement or maintenance of rights, or restrictions on use, w ith respect to the Product Intellectual Property, w hether or not required to be kept or maintained under any Law ; bu t excluding ( i ) the Excluded Data and Materials and ( ii ) any items to the extent that any Applicable Law prohibi ts their transfer