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. 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. 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 Xxxx 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. 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. 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, provided that such changes shall be in accordance with the Clinical Quality Agreement. [***] = Certain confidential information contained in this document, marked by brackets, is omitted because it is not material and would be competitively harmful if publicly disclosed.
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
Changes to Manufacturing. Surmodics shall notify Xxxxxx 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 Xxxxxx. Upon receipt by Xxxxxx of any such request for consent, Xxxxxx 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 Xxxxxx 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 Xxxxxx 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
