definiens: means the Calendar Year in which Spark commencesthe Manufacture of a Batch of Drug Substance, whether to be supplied as a Batch of DrugSubstance or as Resulting Vials of Drug Product to [COMPANY], pursuant to a Purchase Order.1.10 means the total amount payable by Spark to the Fill andFinish Subcontractor for each Batch of Diluent Product as calculated in accordance withAccounting Standards, including:(a ) the internal and external costs of Spark that directly relate to the Manufactureof a Batch of Diluent Product ( including fees paid to the Fill and Finish Subcontractor);(b ) any fees charged by the Fill and Finish Subcontractor for [ * * ] ; ( c ) any pass - through costs together with any mark - up thereto for the purchase ofMaterials charged by the Fill and Finish Subcontractor;(d ) any fees charged by the Fill and Finish Subcontractor relating to [ * * ] ; ( e ) the applicable categories and components thereof identified in Column B ofExhibit A attached hereto ( excluding all other columns ), which categories and components shallserve as the general basis for calculating for any Calendar Year, subject to ( i ) the JSC ’s discussion and input as to the specific units and allocation methodologiesto be used to calculate the costs for each such category and components thereof for a particularCalendar Year, ( ii ) the provision of supporting details on cost allocations to the Cost of DiluentProduct, and ( iii ) the Parties ’ understanding that in some Calendar Years, it is possible that acategory or any of its components thereof may include no costs ; and(f ) any other items as mutually agreed by the Parties in writing from time to time