definiens: means, with respect to a Product, the plan and timelines for the Development ofsuch Product, and which shall include ( i ) a comprehensive plan as determined in accordance with this Agreement and anyapproved updates or amendments thereto in accordance with this Agreement, for the Development by or on behalf ofSanten of such Product, including expected timelines and nonclinical, clinical, manufacturing, regulatory, and product riskassessment activities, ( ii ) a schedule of Development activities to be conducted and the identiﬁcation of the Partyresponsible therefor ( including subcontractors and Sublicensees ), including a non - binding estimate of the number of FTEsto be allocated to the relevant Development activities, ( iii ) an overview of the clinical trials anticipated to be conducted tosupport Marketing Approval of such Product and related timelines, ( iv ) at an appropriate stage of Development, a publicationstrategy, ( v ) at the appropriate stage, plans related to Manufacturing of such Product, ( vi ) the regulatory plan for suchProduct, and ( vii ) the corresponding Development Budget