definiens: means the plan setting out activities to be underta ken in Developing the Licensed Products in the Field in the Territory, together with timelines for such activities, incl uding the proposed clinical trials and regulatory plans, as w ell as outlining the key elements involved in obtai ning Regulatory Approval of the Licensed Products in the Field in t he Territory, as may be amended from time to time i n accordance with Section 4.01 ( Development in the Field in the Terri tory ), which plan ( a ) Licensee shall ensure is at all times consistent with the terms and conditions of t his Agreement and all In - License Agreements, ( b ) Li censee shall ensure is focused on efficiently obtaining Re gulatory Approval for Licensed Products in each Jur isdiction in the Territory, while taking into consideration pote ntial impacts on the Development or Commercializati on of any Eravacycline Product outside of the Territory or Fi eld and ( c ) shall include in reasonable detail ( i ) all Development activities reasonably anticipated to be undertaken by the Licensee Entities, ( ii ) the endpoints for al l clinical trials contemplated by such plan, ( iii ) which clinical tri al is intended to be a pivotal trial and ( iv ) all r egulatory activities and interactions anticipated to be conducted by the Licensee Entities in support of Regulatory Approva l of the Licensed Products in the Field in the Territory, in cluding all planned Regulatory Filings to be submit ted in connection with such approvals