Changes in Manufacturing Process. Novasep shall not change or modify the Manufacturing Process or any of the Manufacturing SOPs, or otherwise make any change in the materials, equipment, process or procedures used to manufacture or test Product that would require a filing with a Regulatory Authority and/or that would affect or reasonably be expected to affect Novasep’s ability to manufacture the Product in accordance with the Specifications or the terms of this Agreement, or Celladon’s ability to use Product supplied by Novasep in the production of Final Product for commercial distribution, in each case, without Celladon’s prior written approval. No changes to Manufacturing Process, the Manufacturing SOPs, the Master Batch Records, material and in-process specifications and analytical procedures for raw materials, in-process testing or batch release testing shall be made except in accordance with the change control procedure set forth in the Quality Agreement. Novasep shall disclose all proposed changes in such manufacturing and testing materials, equipment, process or procedure to Celladon at a level that would be sufficient to allow Celladon to understand such changes and comply with applicable requirements of Regulatory Authorities. If Celladon agrees to allow any such change requiring Celladon’s approval to be implemented, then the parties shall revise the Manufacturing SOPs and the relevant Specifications in writing accordingly, if applicable, in compliance with the requirements of the Quality Agreement. Any actual costs incurred by Novasep in making changes to the Manufacturing Process or the Manufacturing SOPs that are requested by Celladon shall be reimbursed by Celladon, in amounts to be agreed by the parties in writing prior to performing such changes.
Changes in Manufacturing Process. No changes shall be made in the -------------------------------- processes or specifications used in producing Bulk Product for Licensed Product without agreement by both parties. If such changes are required for regulatory reasons, neither party shall unreasonably withhold its consent to such changes. The parties shall enter into an Agreement for the manufacturing of Bulk Product substantially similar to that attached as Annex C.
Changes in Manufacturing Process. Biocon shall not change or modify any of the Specifications or Manufacturing SOPs, or otherwise make any change in the facilities, materials, equipment, processes or procedures used to Manufacture Clinical Material that would require a filing with a Regulatory Authority and/or that would reasonably be expected to affect Biocon’s ability to Manufacture and supply the Clinical Material in accordance with the Specifications and the terms of this Agreement, without Xxxxxxxxx’s prior written approval. No changes to the Specifications, the Manufacturing SOPs or the Master Batch Records shall be made except in accordance with the change control procedures of the Quality Agreement. Biocon shall disclose all proposed changes in such Specifications, manufacturing and testing materials, equipment, processes or procedures to Equillium at a level that would be sufficient to allow Equillium to understand such changes and comply with Applicable Laws. If Xxxxxxxxx agrees to allow any such change requiring Xxxxxxxxx’s approval to be implemented, then the parties shall revise Manufacturing SOPs and the relevant Specifications in writing accordingly, if applicable, in compliance with the requirements of the Quality Agreement.
Changes in Manufacturing Process. No changes shall be made in the processes or specifications used in producing Substance for Licensed Product without agreement by both parties. If such changes are required for regulatory reasons, neither party shall unreasonably withhold its consent to such changes.
Changes in Manufacturing Process. In the event that Seller desires to change the manufacturing process in such a way as to affect the mechanical fit, electrical performance, serviceability or safety requirements of such Products, Seller shall notify SonicWALL in writing within a reasonable period (no less than thirty (30) days) prior to the effective date of the proposed change. Examples of changes which require notification include, but are not limited to, the following: • Changes in major test equipment • Changes in test methods or environment • Changes in manufacturing facility locations • Changes in production line layout Seller agrees to provide verbal notification to the appropriate SonicWALL Supplier Engineer of all other process changes which do not affect from, fit, function, serviceability or safety. Seller shall implement changes in the manufacturing process that effect the mechanical fit, electrical performance, serviceability or safety of the Product only if collected quality/evaluation data verifies that quality and reliability and safety levels of the Product would be sustained and/or improved as a result of such change. The results of the evaluation shall be submitted to SonicWALL for review.
Changes in Manufacturing Process. YBS will give Enovix [****] days advance written notice of any proposed changes (“Proposed Change Notice”) in site characteristics, Exhibit 10.1 materials and/or to its Manufacturing Process, which might affect the form, fit, performance, maintainability, operation, function, reliability, interface interconnectability, compatibility, design rules, models, or size of Products. Such Proposed Change Notice will describe the nature of the proposed changes, including reasons for the changes, the anticipated schedule for implementation of the changes and other relevant technical and logistic considerations, including without limitation quality and reliability data to the extent available. Enovix will approve or disapprove any such proposed changes promptly, but in no event no later than [*****] days after receipt of the Proposed Change Notice. If Enovix disapproves such proposed changes within the [*****] day period, YBS will continue to manufacture and deliver Products using the old Manufacturing Process as originally agree to by the parties hereunder.
Changes in Manufacturing Process. Lonza shall not change or modify any of the Manufacturing SOPs, or otherwise make any change in the materials, equipment, process or procedures used to manufacture or test any Bulk Product Component that would require a filing with a Regulatory Authority and/or that would reasonably be expected to or affects Lonza's ability to manufacture the Bulk Product Components in accordance with the Bulk Specifications or the terms of this Agreement, without first obtaining Altus' prior written approval. No changes to Manufacturing SOPs or the Master Batch Records shall be made except in accordance with the change control procedure of the Quality Agreement. Lonza shall disclose all proposed changes in such manufacturing and testing materials, equipment, process or procedure to Altus at a level that would be sufficient to allow Altus to understand such changes and comply with Regulatory Standards. If Altus agrees to allow any such change requiring Altus's approval to be implemented, then the Parties shall revise Manufacturing SOPs and the relevant Bulk Specifications in writing accordingly, if applicable, in compliance with the requirements of the Quality Agreement. Any actual costs incurred by Lonza in making changes to the Manufacturing SOPs that are requested by Altus shall be reimbursed by Altus, in amounts to be agreed by the Parties in writing prior to performing such changes.
Changes in Manufacturing Process. Product or Manufacturing Locations. In the event that Supplier desires to change the Product or its fundamental manufacturing process, Supplier shall notify Dot Hill in writing within a reasonable period (no less than [...***...] unless such shorter period is agreed to by Dot *** Confidential Treatment Requested Dot Hill Confidential 71. Hill in advance based on the critical nature of implementation of the change, which agreement will not be unreasonably withheld, delayed or conditioned) prior to the effective date of the proposed change and provide Supplier deviation, Engineering Change Request (“ECR”)/ECO) or process change notification document(s) to Dot Hill for formal review/approval. [...***...], and/or will have a negative impact on Product quality or reliability. Examples of changes which require notification include, but are not limited to, the following:
Changes in Manufacturing Process. Specifications. ARIAD shall be responsible for performing, or causing its Third Party manufacturer to perform, all validation testing of the Manufacturing Facility and for validating all manufacturing processes in accordance with cGMPs and all other applicable Regulatory Authority requirements for the countries listed on Appendix A as appropriate for the phase of product development. ARIAD may amend or supplement the manufacturing process for API, the CMC Data for API and/or the Specifications for API in its sole discretion and with notice to MEDINOL. The written notice shall be in reasonable detail and provided as soon as practicable after the decision by ARIAD to make such alteration is made to allow MEDINOL, together with the Joint Manufacturing Committee, to evaluate any impact such alteration may have with respect to MEDINOL’s use of API in its development or manufacture of MEDINOL Licensed Products.
Changes in Manufacturing Process. In the event that Supplier desires to change the fundamental manufacturing process in such a way as to affect the mechanical fit, electrical performance, serviceability, or safety requirements of such Products, including, but not limited to, changes in major test equipment, changes in burn-in time or environment, changes in manufacturing facility locations, Supplier shall notify Logitech in writing within a reasonable period (no less than thirty (30) days) prior to the effective date of the proposed change. If extenuating circumstances require immediate attention and implementation of such changes in order to prevent a direct impact to the production schedule, Supplier shall notify Logitech in writing of the proposed changes. Logitech shall use its reasonable efforts to respond in writing forty-eight (48) hours of receipt of said notification. Supplier shall implement such changes in the process only if collected quality/evaluation data verifies that quality and reliability levels would be sustained and/or improved as a result of such change. The quality data will be submitted to Logitech for review before implementing the change.
