definiens: means, in relation to [COMPANY], ( i ) for any Product and/or component of a Product that isManufactured by [COMPANY], ( a ) the costs of direct material purchased for use in the Manufacture of the Productand the costs of the Manufacture and supply of the Product ( including any delivery device such as the pre - filled syringe or any autoinjector if sold ( or, in the case of the clinical supply, used ) with the Product),(b ) depreciation, repair, maintenance and operating costs of the production facilities utilized in the * Confidential Treatment Requested 6 Manufacture of the Product, ( c ) the costs of quality, stability and in - process controls, ( d ) building operatingcosts, other than any included in the subpart ( b ) above, ( e ) direct labour costs and reasonable overheadcosts, ( f ) the costs of non - capitalized manufacturing process improvement and cost reduction efforts, ( g ) thecosts of filling, finishing and packaging the Product ; and ( h ) Third Party Royalties, in each case asdetermined in conformity with IFRS, consistently applied and to the extent utilized in and directly allocable tothe production of the Product without allocating any excess idle capacity in any manufacturing facility to theproduction of the Product and/or ( ii ) to the extent that the Product or any component thereof ( including anydelivery device such as the pre - filled syringe and/or autoinjector if sold, or in the case of clinical supply, usedwith the Product ) is Manufactured on behalf of [COMPANY] by a Third Party subcontractor, the actual amount paid byUCB to such Third Party for such Product or such component as delivered to [COMPANY]