Changes to Manufacturing Clause Samples
The "Changes to Manufacturing" clause defines the procedures and requirements for making modifications to the manufacturing process, materials, or specifications of a product. Typically, this clause outlines how one party must notify the other in advance of any intended changes, and may require written approval before implementing such changes. For example, if a supplier wants to switch to a new component or alter a production method, they must follow the steps set out in this clause. Its core function is to ensure that all parties maintain oversight and control over product quality and consistency, thereby minimizing risks associated with unapproved or unexpected changes.
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Changes to Manufacturing. Oculus shall not make any changes to the Manufacturing process or equipment for Products without the approval of Ruthigen. At the request of Ruthigen, Oculus shall provide document of any proposed changes for review by the Parties.
Changes to Manufacturing. Surmodics shall notify ▇▇▇▇▇▇ in writing at least [**] prior to (A) making any proposed change or relocation of the manufacturing site for the Product or (B) engaging or substituting any Third Party to perform any of Surmodics’ obligations hereunder. Relocation of the manufacturing site or engagement or substitution of a Third Party to perform any of Surmodics’ obligations hereunder shall require the prior written consent of ▇▇▇▇▇▇. Upon receipt by ▇▇▇▇▇▇ of any such request for consent, ▇▇▇▇▇▇ shall respond in writing within [**] following its receipt of notice from Surmodics. Any new facility or Third Party to be utilized by Surmodics shall be subject to a new and separate audit by ▇▇▇▇▇▇ quality assurance personnel in accordance with Section 4.1.8, and Surmodics shall use Commercially Reasonable Efforts to have the new manufacturing site or Third Party become acceptable to ▇▇▇▇▇▇ quality policies within [**] of relocating Product Manufacture or engaging such Third Party. Except as otherwise provided herein, no relocation or engagement or substitution of a Third Party to perform any of Surmodics’ obligations hereunder shall relieve CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. Surmodics of its obligations to timely deliver the Product in accordance with the Specifications hereunder.
Changes to Manufacturing. Each Party may make changes from time to time to its Compound or the Manufacturing Site, provided that such changes shall be in accordance with the Clinical Quality Agreement.
Changes to Manufacturing. (A) In the event that either Party requests or proposes a change to Manufacturing of Product or is informed by a Governmental Authority that a change is required, the other Party will promptly review and discuss such request or proposal (as applicable) in good faith, and shall not unreasonably withhold consent to the implementation of any such request or proposal (as applicable); provided that such change is permitted under Applicable Law and by the applicable Governmental Authorities. For clarity, Amneal will not implement (or permit any Permitted Subcontractor or Affiliate to implement) any material changes relating to the Manufacturing of Drug Substance or Drug Product, including changes relating to Components, without the prior written consent of Metsera, not to be unreasonably withheld, conditioned or delayed, provided that any such material changes that are required by Applicable Law or a Governmental Authority shall require prior written notification to Metsera to the extent practicable, but not Metsera’s prior written consent.
(B) Amneal shall bear all costs and expenses directly or indirectly attributable to: (i) changes required by Applicable Law or Governmental Authorities relating to the applicable Facility, or to the establishment, maintenance and improvement of cGMP with respect to the applicable Facility, in each case that are not specific to the Products; (ii) changes requested by Amneal, any of its Affiliates, or its Permitted Subcontractors; and (iii) changes in the Components or suppliers of Components, that are not requested by ▇▇▇▇▇▇▇. Metsera shall bear all other reasonable and direct costs and expenses of any changes to the Manufacturing of Product. For clarity, if Amneal requests changes to Components or suppliers of Components, Amneal shall bear costs and expenses attributable to such changes.
Changes to Manufacturing. If changes to the Specifications of DP and/or DS are required, Celltrion will provide prior notification to Rani. Following the change of control process, where required, necessary regulatory applications may be submitted to regulatory authorities. All other updates, including regulatory authorities’ approval, will be implemented in accordance with change of control process, and be notified to Rani. Any reasonable and documented additional costs incurred by ▇▇▇▇ as a result of any changes to the Specifications of the DP and/or DS shall be borne by Celltrion. Celltrion will notify Rani in writing of any changes in or to the Specifications, Celltrion’s manufacturing facilities or procedures, vendors, raw materials or capital equipment that will or may require Rani to amend its Regulatory Filings related to Product or otherwise as reasonably necessary to enable Rani to fulfill its regulatory obligations with respect to Product.
Changes to Manufacturing. Novartis may make changes from time to time to the Novartis Compound or the Manufacturing Site or adapt the specifications of the Novartis Compound; provided that any such changes shall be in accordance with the Quality Agreement and proper notice is provided to Olema of such changes as set forth in the Quality Agreement.
Changes to Manufacturing. Each Party may make changes from time to time to its Compound or the Manufacturing Site in compliance with the Quality Agreement (with respect to the Menarini Compound) and this Agreement (with respect to the Context Compound) and as prior discussed in the JDC.
Changes to Manufacturing. Each Party may make changes from time to time to its Compound or the Manufacturing Site in accordance with the Clinical Quality Agreement; provided that the intended changes would not require a submission, amendment or variation to the Platform Study IND or the Sub-Study, and provided further that the Party making such change provides the other Party with prior written notice of the intended changes. In the case of proposed changes to the Compound or the Manufacturing Site which would require a submission, amendment or variation to the Platform Study IND or the Sub-Study, the Party proposing such change shall provide prior written notice to the other Party of such intended changes, providing reasonable detail, and the Party receiving such notice shall consider such request in good faith.
Changes to Manufacturing. MSD may make changes from time to time to the MSD Compound or the Manufacturing Site, provided such changes shall be in accordance with the Clinical Quality Agreement. 8.8.
Changes to Manufacturing. Subject to Section 12.2, each Party may make changes from time to time to its Compound or the Manufacturing Site in accordance with the Clinical Quality Agreement; provided that the intended changes would not require a submission, amendment or variation to any IND in respect of the activities under the Development Plan, and provided further that the Party making such change provides the other Party with prior written notice of the intended changes, including any product and formulation changes and associated impact assessment that may influence the clinical supply strategy and management. In the case of proposed changes to the Compound or the Manufacturing Site which would require a submission, amendment or variation to any IND in respect of the activities under the Development Plan, the Party proposing such change shall provide prior written notice to the other Party of such intended changes, providing reasonable detail, and the Party receiving such notice shall consider such request in good faith. 12.11