definiens: means the fully - allocated internal and external costsincurred by Akebia in implementing the Current Global Development Plan, calculated inaccordance with the Accounting Standards applicable to Akebia, consistently applied andreflected in its audited financial statements.1.43 means the plan setting forth the Development activitiesthat have been undertaken and will be undertaken by or on behalf of Akebia, and its Affiliates andlicensees ( including Licensee, if applicable pursuant to Section 4.1 ( Current GlobalDevelopment ) ), for the purpose of Developing the Licensed Compound and the LicensedProducts and obtaining Regulatory Approval from [ * * * ] for the Licensed Products for the DD - CKDIndication and the NDD - CKD Indication [ * * * ], together with the budget and timelines for suchactivities including the proposed clinical trials and regulatory plans, as well as outlining the keyelements involved in obtaining Regulatory Approval of the Licensed Products from the [ * * * ] in theDD - CKD Indication and the NDD - CKD Indication in the [ * * * ], as the same may be amended fromtime - to - time in accordance with this Agreement