definiens: means . to the extent they relate to the Product and to the extent owned or licensed by ROCHE . the NDAs and INOs described in Articles 1_3 and 1_4 . all supplements thereto and all regulatory files relating thereto . and any and all < i } regulatory filings and supporting documents . clinical studies and tests ( excluding OEA licenses . and wholesale . distributor and pharmacy - licenses ) relating to Il1e Product ; and ( ii ) records maintained under GMP . or other record keeping or reporting requirements oflhe FDA, the Environmental Protection Agency . the Occupational Health and Safety Administration or any other governmental or regulatory authorities, including all investigational new drug applications, FDA waming letters, FDA notices of adverse finding letters, FDA audit reports ( including any responses to such reports ) . all other correspondence and communications with governmental or regulatory authorities in connection with the Product . adverse event files _ documents related to drug efficacy study implementation, and IND safety reports and complaint files with respect to the Product