definiens: means all information and data included in, generated in connection with, or made a part of either or both ofthe Studies, and further including all meta - data about the Studies ( e.g., the data dictionary and database structures),as well as final study reports, manuscripts and correspondence and other records of regulatory interactions related tothe Studies.[*CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT . EACHSUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK * * * *, HAS BEEN FILEDSEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION . ] ( d ) means all materials, manuals, file descriptions and other written information or computer softwareprovided by [COMPANY] to [COMPANY] that describes or facilitates access to, or the organization and use of, theStudies or Data including, but not limited to, financial disclosure statements from clinical investigators whoparticipated in the Studies