definiens: means all costs incurred by a Party identifiable to the Development as well as overhead costs of the functions that directly support the Development ( as calculated in accordance with GAAP and using the same allocation methods that the Party incurring ~ such costs uses throughout its operations, but in all events excluding genera x corporate overhead ), all as specified in the Development Plan and the Development Budget . Development Costs shall · 3 · consist of Scientific FTE 's ( as defined in section 3.3 ) and out - of­pocket costs~ Such costs shall include, without limitation : ( & ) l : the cost of Goods for the Product used in the Development . ( including early batches of the Product for Regulatory Approval, to the extent not re - used later in commercial SaleS ): ] ( ~)~irect costs for outside professional services, including, but not limited to, toxicology studies or clinical studies \)V performed by Third parties~ ( 0 ) Girect cha ~ es for materials ( including chemicals, animals and lab supplies);~ . ( 4 ) ( fosts incurred in connection with regulatory sUbmissionsZland ( e ) ~osts for the process development of the product : l 1.12 means the Food and Drug Administration of the USA