definiens: means, with respect to each Cost - Share Product, the sum of the following items, in eachcase to the extent incurred by Decibel or any of its Affiliates and directly attributable to Shared Development Activities with respect to suchCost - Share Product in accordance with this Agreement and the Post - POC Operational Development Plan ( including the Shared DevelopmentCost Budget ) or, with respect to the conduct of an Adaptive Trial that [COMPANY] has elected to include in Shared Development Activitiespursuant to Section 13.3(b)(ii ) prior to the Adaptive Trial Interim Point for such Adaptive Trial, the Initial Operational Development Plan(including the Adaptive Trial Budget ), if applicable, for such Cost - Share Product and to the extent that such items do not include any costsrelated to any Development activities other than Shared Development Activities:(a ) Out - of - Pocket Costs ( including fees and expenses ) incurred in performing any Shared Development Activities;(b ) Shared Development FTE Costs ; 22(c ) license fees and payments associated with an in - license for [COMPANY] Contributed Technology included in a Cost - Share Product that is a [COMPANY] Contributed Collaboration Product in a country, but only if such fees and payments are incurred after theFinal Election Period with respect to such [COMPANY] Contributed Collaboration Product under any in - license of Intellectual Property that theParties ( and their respective Intellectual Property counsel, or in the event of a dispute, the Technical Expert(s ) ) determine is required for theDevelopment, Manufacture, use, offer for sale, sale or importation of the [COMPANY] Contributed Technology included in such RegeneronContributed Collaboration Product in accordance with the licenses in Section 5.1(a)(ii ) with respect to such [COMPANY] ContributedCollaboration Product, to the extent it does not relate to ( i ) any active pharmaceutical ingredient, Antibody, recombinant protein, gene therapyor nucleic acid sequence included in or combined with such [COMPANY] Contributed Collaboration Product that is not an Active Agentcontributed by [COMPANY] for such [COMPANY] Contributed Collaboration Product or ( ii ) any specific formulation(s ) that are not contributed byRegeneron for such [COMPANY] Contributed Collaboration Product ( e.g., to the extent specific to such [COMPANY] Contributed Technologyincluded in such [COMPANY] Contributed Collaboration Product ), but, for clarity, ( A ) not including payments based on Net Sales of suchRegeneron Contributed Collaboration Product ( which are subject to the provisions of Section 13.5(f ) ) and ( B ) only for so long as suchRegeneron Contributed Collaboration Product remains a Cost - Share Product ; and(d ) the Manufacturing Cost for the quantities of such Cost - Share Product actually used to perform the Shared DevelopmentActivities for such Cost - Share Product under this Agreement ( including reasonable quantities not actually used by patients but needed foradequate clinical supply chain ) in accordance with the applicable Post - POC Operational Development Plan