definiens: means, with respect to a Product, [COMPANY] ’s plan and timelines for theDevelopment of such Product, and which shall be with respect to any ( a ) Product that is not a Cost Share Product, a high - level plan as determined in accordance with this Agreement from time to time that outlines the material activities to beconducted by or under the authority of [COMPANY] with respect to such Product and expected timelines, including at least thoseDevelopment activities to be conducted in order to obtain Marketing Approval for such Product to the extent such activitiesare necessary to meet [COMPANY] ’s obligations under Section 6.3, and ( b ) Cost Share Product, ( i ) a comprehensive plan asdetermined in accordance with this Agreement and any approved updates or amendments thereto in accordance with thisAgreement, for the Development by or on behalf of [COMPANY] of such Cost Share Product, including expected timelines andnonclinical, clinical, manufacturing, regulatory, and product risk assessment activities, ( ii ) a schedule of Developmentactivities to be conducted and the identiﬁcation of the Party responsible therefor ( including subcontractors andSublicensees ), including a non - binding estimate of the number of FTEs to be allocated to the relevant6 Development activities, ( iii ) an overview of the clinical trials anticipated to be conducted to support Marketing Approval ofsuch Cost Share Product and related timelines, ( iv ) at an appropriate stage of Development, a publication strategy, ( v ) at theappropriate stage, plans related to Manufacturing of such Cost Share Product, ( vi ) the regulatory plan for such Cost ShareProduct, and ( vii ) the corresponding Development Budget