definiens: means all books, records, files, documents, docum entation, servers and hard drives, digital storage devices, cloud - based storag e accounts, databases or database files or entries, and correspondence ( in each case, in paper or electroni c form, to the extent the same exists in electronic form ), including : ( a ) all records with respect to supply s ources ; ( b ) all records containing discovery, pre - c linical, research, process development, analytical and quali ty control data ; ( c ) all reports relating to the re search, development or manufacture of products ; ( d ) all rec ords, including vendor and supplier lists, manufact uring records, sampling records, standard operating proce dures and batch records, related to manufacturing o f products ; ( e ) all laboratory notebooks ( in paper or electronic form ) and records relating to materials, compounds, compositions of matter or products or relating to t heir biological, physiological, mechanical or other properties or compositions ; ( f ) all invention disclosure forms, patent applications and other documents pertainin g to the Prosecution of Patents, the prosecution histories a nd file wrappers for any Patents and correspondence relating thereto, any memoranda and legal opinions and other legal advice relating to the patentability of inve ntions and all written communications to and from the patent o ffice in any jurisdiction, including all office act ions, responses to office actions, notices of allowance, notices of issuance and certificates ; ( g ) all corre spondence, minutes or other communications with the FDA or Reg ulatory Authorities outside the United States ; ( h ) all litigation records ; ( i ) all tax records ; and ( j ) al l business and financial records ( including budgets and ledgers )