Processing Changes Sample Clauses
Processing Changes. Substituting Locations may take up to ninety (90) days to complete, depending on the accuracy of the information we receive and the timely completion and return by you of the documents we require. You agree to pay the Monthly Payment until you have fully complied with this process and we approve your proposed transfer or location substitution.
Processing Changes. (a) Once a DMF has been lodged with the APVMA Supplier shall not make any regulatory changes to the Manufacturing Process that would impact the APVMA’s acceptance of the quality and purity of the Product, the Master Batch Record or Product Specifications for the manufacture of the Product, without the prior written consent of Customer, such consent shall not be unreasonably delayed or withheld.
(b) Customer may request changes to the Manufacturing Process, Master Batch Record, the Product Specifications, storage, testing or analytical methods or any starting materials for the manufacture of the Product, provided that any such changes which impact the cost of manufacturing the Product inclusive of any process development, re-validation, scale-up and/or regulatory filings necessary to support such changes will be reflected in a corresponding increase in the Fees paid by Customer under this Agreement. The notice of any such change by Customer shall comply with the cGMP documentation system and SOPs maintained by Supplier at its production site.
(c) In the event of a change to the Manufacturing Process, Master Batch Record or the Product Specifications, the relevant documents and related Exhibits to this Agreement will be revised accordingly.
(d) All operational Master Batch Records and SOP’s utilized by Supplier are to be in the English language.
Processing Changes. The Seller is responsible and agrees to inform SI of any changes to the raw material, router, bill of materials, service, or method of manufacture and validations that affect the design characteristics (design outputs) and/or the quality assurance specifications of the device. These changes will not be acceptable to or binding on SI unless agreed to in writing by SI. ▇▇▇▇▇▇ agrees to immediately inform SI of nonconforming product for the purpose of disposition by SI as to the acceptability of the product.
Processing Changes a) Supplier shall not make any material changes to the Manufacturing Process, starting materials, the Master Batch Record or Product Specifications for the Manufacture of the Product except in accordance with the Quality Agreement. For clarity, formatting changes in the documentation related to the Master Batch Record shall not be deemed a “material” change under this Section 3.5(a).
b) Customer (or Supplier, if changes are necessitated by Applicable Law) may request reasonable changes to the Manufacturing Process, the Master Batch Record, the Product Specifications, storage, testing or analytical methods or any starting materials for the Manufacture of the Product [* * *]. The notice of any such change by Customer shall comply with the cGMP documentation system and standard operating procedures maintained by Supplier at the Facilities. No material modifications or additions to the machinery, equipment and other fixed assets used by Supplier in the manufacture and supply of the Product to Customer shall be required without the consent of Supplier, which consent may be granted or withheld in Supplier’s sole discretion.
c) In the event of a change to the Manufacturing Process, the Master Batch Record or the Product Specifications, the relevant documents and related Exhibits to this Agreement will be revised accordingly.
d) All operational Master Batch Records and standard operating procedures utilized by Supplier are in the German language. Any requirement by Customer for translation of such records will be billed at cost.
Processing Changes. Seller shall notify Buyer of major changes in product and/or process and changes of manufacturing equipment, facility location change, or sub-tier changes. Seller shall obtain Buyer’s prior written approval for said changes. Seller shall work with Buyer to accommodate Seller’s written change notice request. If Seller does not provide a change request and/or the buyer does not approve/ complete the written change request, Buyer shall have the option of cancelling this Purchase Order and shall have the option to not pay for those Goods completed or in process.
Processing Changes. Seller shall notify Latitude of any changes in product and/or process, changes of suppliers, or changes of manufacturing facility location and Seller shall obtain Latitude's prior approval for said changes. Seller shall include this provision in all related subcontracts.