definiens: means ( a ) all toxicology / safety and other relevant scienti fie safety data owned, licensed or developed by [COMPANY] and its Al1ihatcs ; ( b ) all toxicology / safety and other relevant scientific data owned, licensed or developed by the licensees or sublicensees of [COMPANY] or its Affiliates or other third parties ( to the extent permitted in the applicable license or other agreements between [COMPANY] and/or its Affiliates and such licensees, sublicensees or other third parties ) on CAPTISOL alone ( and not in conjunction with a product ronnulatiun ) ; and ( c ) all CMC and manufacturing process data relating to the preparation of CAPTISOL, in each case to the extent necessary or useful for the fiJrmulation of the Licensed Product . for purposes of clarity, shall include all dossier of data and infOlmation on CAPTISOL provided by [COMPANY] under the Limited Clinical ese Agreemcnt, including without limitation Material Safcty Data Sheets, certificates of analysis, information on muterial stability and storage conditions, packaging, specifications, test methods, reference standards, and re - evaluation dates for CAPTISOL as well as known or expected adverse events related to the usc ofCAPTISOL