Regulatory Support Activities. Any regulatory support documentation (including, without limitation, documentation related to pre-Approval inspection and provision of any data and information (in English) relating to Lonza’s performance under this Agreement) required and agreed to by Customer to support and maintain the Approval of the Product from the Facility shall be performed and supported by Lonza as reasonably requested by Customer. [***]. If required, additional regulatory support activities shall be approved by the Customer in advance, [***] at a price set out in a separate Project Plan.
Regulatory Support Activities. Any regulatory support activities (including Pre-Approval Inspections) required and agreed to by Client to support Regulatory Approval of the Product from the Facility shall be performed and supported by SBL as reasonably requested by Client. All such regulatory support activities are excluded from the price of Process Validation Batches, shall be approved by the Client in advance, and shall be paid for by the Client at the price set out in the applicable PSA. SBL shall notify Client according to the applicable QAG provisions of any contacts or inquiries by the Regulatory Authorities, including inspections, Pre-Approval Inspections, sample requests, and written correspondence and its result, related to the Product.
Regulatory Support Activities. Any regulatory support activities (including Pre-Approval Inspections) required and agreed to by Client to support Regulatory Approval of the Product Manufactured at the Facility shall be performed and supported by SBL as reasonably requested by Client. All such regulatory support activities are excluded from the price of Process Validation Batches, shall be approved by Client in advance, and shall be paid for by Client at the price set out in the applicable PSA. Unless otherwise agreed by the Parties, Client will have the sole right to correspond with and submit regulatory applications and other filings to Regulatory Authorities to obtain Regulatory Approvals or other approvals to import, export, conduct clinical trials with, or sell the Product, alone or in combination with other products when and as Client may deem useful and/or necessary. Accordingly, except as otherwise required by Applicable Laws and Regulatory Authorities’ requirements, SBL will not correspond directly with any Regulatory Authority with respect to the Product without, in each instance, first obtaining Client’s prior written consent.
Regulatory Support Activities. Any regulatory support activities required and agreed to by Client to support Regulatory Approval of the Product from the Facility shall be performed and supported by SBL as reasonably requested by Client and shall be paid for by the Client at the price set out in the applicable PSA.
