definiens: means, with respect to a Licensed Product, a plan prepared by Company for the then current Calendar Yearand [ * * * ] setting forth a summary of the Development activities to be conducted for such Licensed Product, including the indications expectedto be targeted, a good faith estimate of reasonable timelines for completing key Development activities and filing of key regulatory submissions(including estimated timelines for commencement of each stage of clinical Development ), and including, where known, the primary endpointsand any comparator or any agents used in combination with a Licensed Compound or Licensed Product for any such studies and anygo - no - go decision criteria for any such studies . The initial Development Plan as of the Effective Date is attached hereto as Appendix 2, andmay be amended by the Company from time to time at the Company ’s sole discretion . A copy of the study protocol for a given study will beprovided to [COMPANY] if available and if requested by [COMPANY]