Process Changes. The Vendor shall notify and obtain approval from the Buyer for changes in product and /or process definitions where required by contract.
Process Changes. The implementation of any and all changes of and/or improvements related to the Goods and/or (performance of the) Services including (business) processes, (raw) materials (including supply source) and/or any other changes that might affect the specifications of the Goods and/or the Services require the prior written approval of Customer. Supplier will inform Customer well in advance of such changes and will enable Customer to control and test the Goods.
Process Changes. At the conclusion of the response period established during the evaluation of the proposed change, the Executive Board shall evaluate whether to approve the Process Change, if an E-MOU change will be required, and a proposed timeline for implementation. Revisions to the E-MOU mandated by approved Process Changes will be performed in accordance with Appendix 3 of this E-MOU.
Process Changes. Seller should notify Buyer when the plans to modify packaging, to change manufacturing locations or processes.
Process Changes. 8.1 Either party may request the other party to accept changes in the production process for wafers, provided, however, any material changes to the production process for wafers that has been previously approved by SMI for production of its wafers, including changes to procedures, flow or specifications, may only be made if such changes are first approved in writing by SMI, which approval shall not be unreasonably withheld.
Process Changes. Any process change must be in accordance with the Process Change Notification (PCN) procedures set forth in Exhibit G.
Process Changes. Seller shall not make any change to the product, process, materials, formulation, packaging, labeling, software, environmental conditions, quality assurance process, equipment, production location, or subcontractor(s) that in any way affect the finished Goods, without prior written notification to, and approval by, Buyer.
Process Changes. Notwithstanding anything herein to the contrary, BIOTIUM shall not amend, change or supplement any of the following, except as may be required to comply with applicable Laws and regulations and Agency requirements, without LICENSEE’s prior written consent: (A) the Specifications; (B) the raw materials used to manufacture the Products; or (C) the process for manufacturing the Products. Any change in any of the foregoing shall, in each case, comply with all applicable Laws, regulations and Agency requirements. BIOTIUM shall notify LICENSEE in advance of making any such change that is required to comply with applicable Laws, regulations or Agency requirements and shall provide all information reasonably requested by LICENSEE related to any such change. In the event that BIOTIUM desires to change any of the foregoing, BIOTIUM agrees to: (i) immediately notify LICENSEE of such change; and (ii) if LICENSEE agrees to such change, be responsible, at its expense, for ensuring that all Products manufactured following such change conform to the Specifications and the Product quality and yields achieved during the validation batches. BIOTIUM shall continue to supply LICENSEE with Products approved under then current regulatory filings until such time as the Products manufactured following such change are permitted under any new regulatory filings. If BIOTIUM makes any regulatory filings or otherwise attempts to obtain any Agency approvals, BIOTIUM must immediately notify LICENSEE whether such changes have been approved or rejected.
Process Changes. Changes to McDATA's controlled manufacturing or repair processes may be periodically reviewed by EMC, and any significant changes [*] or the type of stress testing performed will be mutually agreed to in advance by McDATA and EMC. Quality information on field and process performance will be furnished to EMC on a monthly or quarterly basis.
Process Changes. Changes to the Existing Process, Services, or Specifications, including changes to any Materials used to Manufacture the Patient Lots or other Deliverable, may only be made in accordance with the QAA. Actual costs incurred as a result of changes will be allocated as follows:
