definiens: ) ] . 3 . Section 1.15 of the Agreement is hereby amended as follows : means the costs incurred by either Party or for its account specifically identifiable to the development of the A viron Product for Regulatory Approval in the Territory and shall consist of ( a ) [ direct labor and materials and out - of - pocket ] costs associated with the conduct of the [ Incremental Studies ( including without limitation the PCI - Medeva Bridging Studies ) ] ; ( b ) Cost of Goods Shipped of any [COMPANY] Product [ used in the Incremental Studies ( including without limitation the PCI - Medeva Bridging Studies ) ] ; and ( c ) direct labor and materials and out .,of - pocket costs associated with the [ filing of any applications for Regulatory Approval ] in the Territory as specified in the Development Plan and approved by the Steering Committee, and all calculated in accordance with reasonable cost accounting methods, consistently applied by the Party performing the work