definiens: ) costs shall mean costs of plant and production management, costs for ensuring sufficient levels of safety, health and environment such as fire brigade, medical services, documentation for License, Development and Commercialization Agreement -Confidential Page 4 of 53 -transportation of hazardous goods . Other GFO costs include costs for the scheduling of production, costs of the maintenance of the bills of materials, costs for the technical support, expenses of the plant administration and general services, costs of information technology ( ) for non - dedicated IT systems such as SAP . Utility costs are costs associated with the consumption of supportive media such as electricity ; water, nitrogen, steam, and air . Ecology costs are costs associated with the deposition of solid or liquid waste, purification of effluent water, and purification of waste air . Variance costs attribute to the following circumstance : Standard Cost of Goods include cost elements which are set at so - called standard costs . They serve as a norm on how much typically a Product costs . Deviations from such standard costs are captured in variances . Inventory re - I devaluation shall mean the gain or loss as a result of the inventory value adjustment due to changes in the standard costs . Non - Product - related production costs shall contain Technical Operations Corporate Headquarter overhead costs, non­Product - allocated QA costs, validation costs, directly expensed IT project costs, and other costs that can not be attributed to specific Products . Write - offs are captured for the destruction of Products that can not be used anymore due to expiration of shelf - life, spoilage in the production process, and transportation mishaps . Third Party royalties are manufacturing- and/or supply royalties paid to Third Parties other than Section 5.6.2 royalties . Costs of Goods Sold shall be determined in accordance with [COMPANY] ' usual and customary accounting methods, which are in accordance with the Accounting Standards