definiens: means all data, data sets, test data, pre - clinica l and clinical trial data, analyses, reports, regulatory filings and approvals and the informatio n therein or associated therewith ( including drug m aster files and device master files, supporting data, regulator y correspondence and meeting minutes ) and rights to reference the same, in each case : ( a ) that are generated by either Party in the cours e of performance pursuant to a Work Plan or under this Agreement ( ) ; ( b ) that are owned or controlled by [COMPANY] prior to t he Effective Date, or generated by [COMPANY] during the term of this Agreement outside of performing th e Work Plans, and are necessary or useful for the e fforts of [COMPANY], its Affiliates or Sublicensees in obtaini ng Marketing Approval for the Device ( ) ; or ( c ) that are owned or controlled by [COMPANY] prior to the Effective Date, or generated by [COMPANY] during the term of this Agreement, and are necessar y or useful for the efforts of [COMPANY] in performing t he Work Plan(s ) or in obtaining Marketing Approval for the Device but excluding any Data related to the Projec t Intellectual Property ( )