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 inclu ding any related software ) owned or Controlled by the [COMPANY] Companies or their respective Affiliates and necessary for or to the extent related to the manufacture, supply, formulation, Labeling or packaging of Product or a Current Product Improvement intended for use, sale or offer for sale in the Territory, including ( a ) any pricing lists, vendor lists or financial data necessary for or to the extent related to the manufacture of Product or a Current Product Improvement intended for use, sale or offer for sale in the Territory, ( b ) any documentation relating to raw materials used in the manufacture of Product ( or any components thereof ) or a Current Product Improvement intended for use, sale or offer for sale in the Territory, or to the suppliers of su ch raw materials, and ( c ) any batch records, flow diagrams, quality control or quality assurance records and data, standard operating procedures, internal good manufacturing practices, audits or assessments, correspondence with any Governmental or Regulato ry Authority and any Product Registrations, manuals and other manufacturing process reports or documentation to the extent related to the Plant or to Product or a Current Product Improvement intended for use, sale or offer for sale in the Territory, but ex cluding any such items set forth on Schedule 1.01(b ) of the [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