Changes in Manufacturing. HSA and FOUNDRY must obtain CUSTOMER’S written approval before changing manufacturing sites or making major changes to the process for any of CUSTOMER’S Products where HSA and FOUNDRY has been qualified or where CUSTOMER is in the process of qualifying HSA and FOUNDRY. In the event that during the term of this Agreement, FOUNDRY finds it necessary to shut down any CUSTOMER product lines in FOUNDRY’S fabs located at Xxxxx Xx, Ichon or Gumi, FOUNDRY agrees to provide CUSTOMER with 6 months’ written notice CUSTOMER shall have the option, as specified in the following subparagraphs, to halt and scrap partially fabricated Risk Production and Production Wafers, paying HSA according to the following formula: Scrap Price = (% of process completed x Wafer Price) % Complete Process Point 50% Before LDD Photo/Implant 70% Before Metal-1 Photo 100% After Metal-1 Photo
Changes in Manufacturing. 12.5.1. Changes to EPIR Product Manufacturing. EPIR agrees to inform SETI in writing within thirty (30) days of any development that directly affects: (a) the production of a EPIR Product or EPIR Independent Product, (b) the Product Specifications, or (c) the standard operating procedures used by EPIR in manufacturing the EPIR Products or EPIR Independent Products. Through the TDB, SETI and EPIR will review such development or changes to the extent they relate to EPIR Products in accordance with the quality control procedures set forth in Exhibit F. Any necessary changes to the Product Specifications or standard operating procedures for EPIR Products will be issued by the TDB. Any necessary changes to the Product Specifications or standard operating procedures for EPIR Independent Products will be issued by EPIR.
Changes in Manufacturing. Purchaser may, upon written notice to Supplier, request changes to the Specifications, and Supplier agrees to negotiate in good faith an appropriate adjustment to the Price in order to accommodate such request.
Changes in Manufacturing. Quality Control and Packaging of the Product. With respect to any changes of the Manufacturing, quality control and packaging of the Product (hereinafter collectively referred to as “Change(s)”), the Parties agree with respect to the implication on the Supply Price as follows:
Changes in Manufacturing. If Connetics decides that change or modification of the production procedure is necessary during the Term for any reason, Connetics shall promptly notify Soltec in writing of the need for such change or modification.
Changes in Manufacturing. After First Article Approval specified in Section E.2.1, the contractor shall not make changes in materials, manufacturing methods, approved subcontractors or processes, or facilities without approval of the PCO. In the event of such changes, the Government reserves the right to require additional FAT at no cost to the Government in order to validate that the changes have not adversely affected trailer performance.
Changes in Manufacturing. (a) Prior to implementation, POLYPEPTIDE shall notify CUSTOMER of any changes to Master Batch Records, analytical methods or PRODUCT-specific standard operating procedures (“SOPs”) of POLYPEPTIDE that would have a material impact on the PRODUCT. POLYPEPTIDE shall implement any such changes only with the prior written consent of CUSTOMER and in compliance with the Quality Agreement.
(b) If facility, equipment, process or system changes are required of POLYPEPTIDE as a result of requirements (including a change in Specifications) set forth by the FDA or any other Regulatory Authority, then, CUSTOMER and POLYPEPTIDE shall review such requirements in accordance with the terms of the Quality Agreement. If POLYPEPTIDE is required to implement changes solely because of manufacturing processes that are specific to the PRODUCT (and, in the absence of such specific manufacturing processes applicable to the PRODUCT, such changes would not be required), then [**] of the costs thereof, reasonably incurred. If POLYPEPTIDE is required to implement changes in order to ensure that the POLYPEPTIDE facility remains cGMP compliant or for any other reason not specified in the preceding sentence, then [**] of the costs thereof. POLYPEPTIDE shall consult with CUSTOMER prior to incurring any costs for which CUSTOMER is responsible hereunder. POLYPEPTIDE agrees to use commercially reasonable efforts to mitigate the costs that are borne by CUSTOMER under this Section 4.2(b).
(c) CUSTOMER, may, from time to time during the Term, request changes to the Specifications for reasons other than described above. POLYPEPTIDE agrees that it shall conduct a good faith review of any requested changes in the Specifications and will use commercially reasonable efforts to implement the changes in accordance with the terms of the Quality Agreement. All changes to the Specifications agreed to by POLYPEPTIDE shall include a reasonable time period for POLYPEPTIDE to implement such changes. In the event of any dispute with respect to whether or not such proposed changes to the Specifications can be reasonably implemented, CUSTOMER and POLYPEPTIDE [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. agree to negotiate in good faith to reach mutual agreement. [**]agrees to be [**] responsible for [**] costs associated with meeting the changes to the Specifications requested und...
Changes in Manufacturing. If facility, equipment, process or system changes are required of Rhein Biotech and GCVC as a result of requirements set forth by any relevant regulatory authority such costs shall be borne by Rhein Biotech and GCVC.
Changes in Manufacturing. 9.9.1 Changes to Master Batch Records and Product Specifications. Xxxxxx agrees to inform Dynavax within fifteen (15) calendar days of the result of any regulatory development or changes to Product-specific Xxxxxx SOPs that materially affect the Production of the Product. Xxxxxx shall notify Dynavax of and require written approval from Dynavax for material changes to Product-specific Master Batch Records and Product Specifications prior to the Production of subsequent Batches of Product.
Changes in Manufacturing
