definiens: means a plan setting forth the Development activities that are(a ) not included in the Current Global Development Plan, ( b ) not [ * * * ], and ( c ) to be undertaken byor on behalf of Akebia and its Affiliates, licensees ( including Licensee, if applicable ), andsublicensees in Developing the Licensed Compound and the Licensed Products and obtaining ormaintaining Regulatory Approval from [ * * * ] for New Indications or New Formulations, as set forthin Section 4.3 ( Additional Development ), together with the budget and timelines for such activitiesincluding the proposed clinical trials and regulatory plans, as well as outlining the key elementsinvolved in obtaining and maintaining Regulatory Approval of the Licensed Products from [ * * * ] ( other than as contemplated in the Current Global Development Plan or [ * * * ] or any [ * * * ] Plan )