definiens: means copies of all files, documents, instruments, papers, books and records, whether on paper or in electronic form in a Database ( but if in electronic format, not including any related software ), owned or Controlled by the [COMPANY] Companies or their re spective Affiliates and necessary for or to the extent related to the development of the Product or a Current Product Improvement or the sale, marketing or distribution of the Product or a Current Product Improvement in the Territory, including ( a ) all market research, marketing plans, media plans, advertising, customer marketing records, call lists or similar materials, pricing lists, current and prospective customer lists and records, including principal contacts, addresses, telephone numbers, purchasing history and payment information, and promotional and marketing books and records, ( b ) any documentation evidencing or embodying the Product Intellectual Property, and ( c ) any documentation to the extent related to investigations being conducted with respec t to the Product or a Current Product Improvement, including pursuant to a Development Contract, or to the receipt or maintenance of regulatory approvals for the Product or a Current Product Improvement in the Territory ( including study protocols, study pl ans, pre - clinical and clinical study test results and data, and investigator and study site lists and contact reports ), but excluding any such items set forth on Schedule 1.01(e ) of the [COMPANY] Company Disclosure Schedule that ( i ) any applicable Law prohibits their transfer, ( ii ) any transfer thereof would subject the [COMPANY] Companies or any of their respective Affiliates to any Liability or ( iii ) are tax files, documents, instruments, papers, books and records