Process Validation Batches Clause Samples
The 'Process Validation Batches' clause defines the requirements and procedures for producing and evaluating batches of a product to confirm that the manufacturing process consistently yields results meeting predetermined quality standards. Typically, this involves manufacturing a specified number of consecutive batches under normal operating conditions, with each batch subjected to rigorous testing and documentation. This clause ensures that the process is reliable and reproducible before full-scale commercial production begins, thereby minimizing the risk of quality failures and regulatory non-compliance.
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Process Validation Batches. Lonza shall 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.
2.5.1 Prior to commencement of Process Validation Batches, Lonza and Customer shall agree a process validation plan identifying the validation requirements of the Manufacturing Process. All process validation activities are excluded from the Price of Process Validation Batches shall be approved by the Customer in advance and shall be paid for by the Customer at the Price set out in the applicable Project Plan.
2.5.2 Any regulatory support activities (including pre-Approval inspection) required and agreed to by Customer to support the Approval of the Product from the Facility shall be performed and supported by Lonza as reasonably requested by Customer. All such regulatory support activities are excluded from the Price of Process Validation Batches, shall be approved by the Customer in advance, and shall be paid for by the Customer at the Price set out in the applicable Project Plan.
Process Validation Batches. Lonza shall 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.
Process Validation Batches. At the request of Licensee, Teikoku agrees to sell Licensee all or a portion of Teikoku’s existing process validation batches of the Current Product and all related supporting documentation, at a price to be agreed by the Parties.
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.
Process Validation Batches. Lonza shall 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.
2.5.1 Prior to commencement of Process Validation Batches, Lonza and Customer shall agree a process validation plan identifying the validation requirements of the Manufacturing Process. All process validation activities are excluded from the Price of Process Validation Batches shall be approved by the Customer in advance and shall be paid for by the Customer at the Price set out in the applicable Project Plan.
2.5.2 Any regulatory support activities (including pre-Approval inspection) required and agreed to by Customer to support the Approval of the Product from the Facility shall be performed and supported by Lonza as reasonably requested by Customer. All such regulatory support activities are excluded from the Price of Process Validation Batches, shall be approved by the Customer in advance, and shall be paid for by the Customer at the Price set out in the applicable Project Plan. For the sake of clarity, the Parties agree that Lonza shall provide regulatory review, at the agreed hourly rate/day rate, with respect to all documents related to any regulatory submission. Lonza shall exercise reasonable commercial efforts to review the documents and provide input in accordance with Customer’s reasonably requested timeline.
Process Validation Batches. Lonza shall manufacture and deliver and Customer shall purchase Process Validation Batches as mutually agreed by the Parties sufficient to document the operability and reproducibility of the Manufacturing Process at the Facility and permit the Parties to complete and file the necessary regulatory documents. Prior to commencement of Process Validation Batches, Lonza and Customer shall agree on a process validation plan identifying the validation requirements of the Manufacturing Process. Any regulatory support activities (including pre-Approval inspection) required by Customer and agreed to by Lonza to support the Approval of the Product from the Facility shall be performed and supported by Lonza as reasonably requested by Customer.
Process Validation Batches. It is agreed that; (i) following agreement by the Parties that the Engineering Batches have demonstrated that the Manufacturing Process can produce Product that meets the Specifications (and the Target Yield as provided in Clause 2.4.3), and the Parties agreeing to proceed; then Lonza shall manufacture [*] (any additional Batches to be agreed between the Parties no later than [*] prior to commencement of the [*] Process Validation Batches referred to in this Clause 2.8.2) Process Validation Batches in [*] at the Visp Facility, and that this is an irrevocable commitment by both Parties and Customer shall pay for such Process Validation Batches. Following the successful completion of the second Engineering Batch, Lonza shall manufacture and deliver Process Validation Batches as mutually agreed by the Parties sufficient to document the operability and reproducibility of the Manufacturing Process and permit the Parties to complete and file the necessary regulatory documents.
Process Validation Batches. Lonza shall 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.
2.4.1 Prior to commencement of Process Validation Batches, Lonza and Radius shall agree on a process validation plan identifying the validation requirements of the Manufacturing Process. All process validation activities that are excluded from the Price of Process Validation Batches shall be approved by Radius in advance and shall be paid for by Radius at the Price set out in the applicable Purchase Order.
2.4.2 Any regulatory support activities (including pre-Approval inspection) required and agreed to by Radius to support the Approval of the Product from the Facility shall be performed and supported by Lonza as reasonably requested by Radius. All such regulatory support activities are excluded from the Price of Process Validation Batches, shall be approved by Radius in advance, and shall be paid for by Radius at the Price set out in the applicable Purchase Order.
Process Validation Batches. 2.11.1 As applicable, Lonza shall manufacture and deliver Process Validation Batches as mutually agreed by the Parties pursuant to a SOW sufficient to support the robustness of the Manufacturing Process and permit the Parties to complete and submit the necessary documents to the Regulatory Authorities.
2.11.2 Prior to commencement of Process Validation Batches, Lonza and Customer shall agree on a process validation plan identifying the validation requirements of the Manufacturing Process and identify necessary regulatory support.
2.11.3 The Price of any regulatory support activities and process validation activities that are in addition to the Price of Process Validation Batches, shall be set forth in the applicable SOW, and shall be paid for by the Customer at the Price set out in the applicable SOW.