definiens: means the 2019 I nitial Development Plan and any other plan for the development of the Licensed Compound for Regulatory Approval and Post - Approval Research in the Territory, including ( a ) a multi - year strategy for Phase IV studies and lifecycle management activitie s, if any, ( b ) a high - level description of non - clinical s tudies and clinical trials and strategy for obtaini ng, maintaining and, if applicable, expanding Regulator y Approvals for the Products, ( c ) an expected timetable for the completion of such non - clinical s tudies and clinical trials and ( d ) Clinical Design Summaries to the extent the Development Plan relate s to a clinical trial, as such plan may be amended or updated from time to time in accordance with this A greement . Each Development Plan shall include sufficient detail to permit Ironwood to assess whet her the Development activities described in such pl an would have an adverse impact on the development or commercialization of a Product outside of the Territory