Common use of Cost to Produce Clause in Contracts

Cost to Produce. RTU, at its sole expense, will provide all labor, utilities, equipment, personnel, facilities, raw materials and components necessary for manufacturing, development and implementation of all appropriate quality control measures, shipping, and storage of the Drug Substance and the Drug Product in compliance with the Specifications and the warranties contained in Article 9 and the Regulatory and Legal requirements of Article 7. RTU shall also be responsible for all process development and scale-up. SAG, at its sole expense, will provide all resources necessary to ship, store, and otherwise handle such Drug Substance and Drug Product in a manner necessary to meet applicable Regulatory and Applicable Law requirements, after delivery of the Drug Substance and the Drug Product to SAG as described in Article 2.9. RTU shall purchase all Additional Materials (as referred to in the relevant Regulatory Approvals) which are needed for the manufacture of the Drug Substance and Drug Products as per the current regulatory files, under its own liability and costs. If RTU wishes to change suppliers, such change shall be subject to SAG's prior written approval, such approval not to be unreasonably withheld, conditioned or delayed and RTU shall bear the costs of such change including any regulatory fees required for any Regulatory Filings by RTU or SAG *Confidential Treatment Requested 5 Article 2.4.

Cost to Produce. RTU, at its sole expense, will provide all labor, utilities, equipment, personnel, facilities, raw materials and components necessary for manufacturing, development and implementation of all appropriate quality control measures, shipping, and storage of the Drug Substance and the Drug Product in compliance with the Specifications and the warranties contained in Article 9 and the Regulatory and Legal requirements of Article 7. RTU shall also be responsible for all process development and scale-up. SAG, at its sole expense, will provide all resources necessary to ship, store, and otherwise handle such Drug Substance and Drug Product in a manner necessary to meet applicable Regulatory and Applicable Law requirements, after delivery of the Drug Substance and the Drug Product to SAG as described in Article 2.9. RTU shall purchase all Additional Materials (as referred to in the relevant Regulatory Approvals) which are needed for the manufacture of the Drug Substance and Drug Products as per the current regulatory files, under its own liability and costs. If RTU wishes to change suppliers, such change shall be subject to SAG's prior written approval, such approval not to be unreasonably withheld, conditioned or delayed and RTU shall bear the costs of such change including any regulatory fees required for any Regulatory Filings by RTU or SAG *Confidential Treatment Requested 5 Article 2.4.SAG