Common use of Process Validation Batches Clause in Contracts

Process Validation Batches. Customer may request Lonza to manufacture and deliver Process Validation Batches as mutually agreed by Parties sufficient to document the operability and reproducibility of the Manufacturing Process and permit the Parties to complete and file the necessary regulatory documents. Any and all validation effort shall be additional and outside the scope of this Project Plan. No Validation effort is currently anticipated as part of the current Project Plan. 2.3.1 Upon request of Customer, Lonza and Customer shall further discuss and agree to a process validation plan identifying the validation requirements of the Manufacturing Process. Any and all process validation activities are not considered as part of the Project Plan and are excluded from the Prices within this Agreement. Any such future Process Validation or Process Validation Batches shall be approved by the Customer in advance and shall be paid for by the Customer at a Price to be determined in a separate Project Plan.