FAMC does not include. A. Plant costs incurred due to product rework, except the reasonable allowance included under item A.2. B. The value of product discarded in the manufacturing operation (other than process related scrap as stated above). C. Allocations of (i) overhead incurred outside of the manufacturing plant such as support, business development, accounting, taxes and legal, and (ii) overhead for any portion of Orion’s production facility not fully utilized for production in Orion’s customary manner. D. Freight, property and sales taxes on finished good shipment and warehousing related to finished goods. E. Inventory carrying costs F. Development Costs or other research and development costs. G. Costs associated with the change of site of manufacture and the change of container, including without limitation the costs of satisfying all registration and other requirements of Regulatory Authorities. H. Any intercompany margins/markups on intercompany transfers between or among manufacturing plants or any of its affiliates. I. Insurance related to product liability. J. Costs related to pharmaceutical development, manufacturing process development or validation, or process scale-up K. General and administrative expenses.
Appears in 4 contracts
Samples: License, Supply, Marketing, Distribution and Collaboration Agreement (Osmotica Pharmaceuticals PLC), License, Supply, Marketing, Distribution and Collaboration Agreement (Osmotica Pharmaceuticals LTD), License, Supply, Marketing, Distribution and Collaboration Agreement (Osmotica Pharmaceuticals LTD)