definiens: means all files, documents, instruments, papers, books and records ( scientific, developmental, distribution, marketing, financial or other)owned by Seller and its Affiliates and relating primarily to the Business or the Product in theUnited States, including all books and records, if any, relating to the Regulatory Approvals andthe IND ; equipment specifications ; analytical specifications and validation reports ; bills ofmaterial ; packaging specifications ; approved and rejected vendor lists and audits ; change controlreports ; product complaints and adverse drug event histories and files ; component and labelingpurchasing specifications ; packaging and quality control SOPs ; stability data, records, charts, reports and SOPs ; quality assurance / control data, records, charts, reports, and SOPs ; budgets;pricing guidelines ; ledgers ; journals ; Assumed Contracts ; customer lists ; supplier lists ; operatingdata and plans ; sales data ; target lists ; sampling lists ; physician lists ; volume prescriber lists ; ineach case whether issued, pending, or in draft form, and whether or not required to be kept ormaintained under any Law, together with all internal and external correspondence, historicalrecords and copies of all of the foregoing, whether in paper or electronic form and whereverlocated, in and outside the United States ; provided that shall not includeany of the foregoing items ( i ) to the extent that any applicable Law prohibits their transfer, ( ii)that were received from third parties in connection with their proposed acquisition of thePurchased Assets, the Products or Business or prepared by Seller and its Affiliates in connectionwith such proposals, ( iii ) that were specifically prepared by Seller for the negotiation of thisAgreement, and ( iv ) to the extent such items are included in the definition of or . The Parties acknowledge and agree that ( i ) to the extent thatany such Books and Records contain information that relates to any product other than theProduct or to any business or operations of Seller and its Affiliates other than the Business, suchBooks and Records shall be redacted to delete such information and ( ii ) to the extent that anysuch Books and Records contain information necessary to permit Seller and its Affiliates toperform their obligations under the Interim Packaging Agreement, Seller and its Affiliates shallnot be required to deliver such Books and Records to Buyer until the Interim PackagingAgreement has expired or been terminated and Seller and its Affiliates shall have the right to usesuch Books and Records in connection with the performance of their obligations under theInterim Packaging Agreement ; provided that Buyer and its Affiliates will be provided withunrestricted access during normal business hours to any and all such temporarily retained Booksand Records