Common use of Process Validation Batches Clause in Contracts

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 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 2.4.1 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 2.4.2 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 avoidance of claritydoubt, the Parties agree it is expressly understood and agreed that Lonza shall provide regulatory review, use commercially reasonable efforts to produce each of the three (3) Manufacturing Process validation Batches in succession and shall commence manufacturing of each of the three (3) Manufacturing Process validation Batches no later than the sixty (60) days from the Commencement Date for such Batches originally estimated 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 time of Lonza’s acceptance of the documents and provide input in accordance with Customer’s reasonably requested timelinebinding purchase order.