Process Change. If Seller implements an ongoing process change at a Mill different from current operations that results in ongoing Negative Impacts, then Buyer shall have the right to discontinue such purchases of such Product from such Mill, and Seller shall have the right to sell such Product to a third party until such time as the Negative Impacts are no longer occurring, with no liability to Buyer under this Agreement or at law or in equity in connection with such process change.
Process Change. Notwithstanding the preceding Section 2.4, any changes to materials, equipment, release testing, any significant manufacturing changes or other aspects of Services addressed in the Quality Agreement (each a “Process Change”) will be subject to a mutually agreeable formal process for joint review and approval set out in the Quality Agreement without the need to amend this MDA or any [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Process Change. Seller agrees to process and package all Materials in conformity with any purchase specifications supplied. At the request of Buyer and prior to delivery of any new or changed Materials, the Seller will provide samples to Buyer for the purposes of inspection and testing. Seller may not alter the function, appearance, characteristics, material or production method or processes, manufacturing location, subcontractors, or material suppliers without advance written approval from Buyer. For all changes, Seller will comply with Production Part Approval Process requirements and/or other applicable industry requirements. Xxxxx's final approval of samples will not affect the Seller's liability for any defects in the Materials.
Process Change. Notwithstanding the preceding Section 6.2 Change in Specifications, any other changes to Raw Materials, vendors of Raw Materials, materials, equipment, release testing, any significant manufacturing changes or other aspects of the Services, including Manufacturing services, addressed in the Quality Agreement (each a “Process Change”) will be subject to a mutually agreeable formal process for joint review and approval set out in the Quality Agreement without the need to amend this CSA or any SOW. The Parties acknowledge and agree that Tricida retains the right to change the Specifications for Product at all times pursuant to Section 6.2 Change in Specifications. Unless otherwise approved by Tricida, no Process Change shall be implemented unless the prior approval of applicable Regulatory Authorities to the change, if required, has been obtained. The Parties will use commercially reasonable efforts to implement such Process Changes and to get timely clearance of such Process Changes by Regulatory Authorities, provided that, unless otherwise agreed by the Parties, all increases in costs arising in connection with such approved Process Change shall be borne by Tricida and any decreases in costs arising in connection with such Process Change shall be passed on to Tricida after Patheon has recovered its reasonable costs The Parties agree that any changes in vendors for Raw Materials shall be made in accordance with an agreed upon procedure and the Quality Agreement, which procedure shall include a process to verify that any new vendor can supply sufficient Raw Materials in a timely manner which does not alter or change the overall quality of the Product. Tricida shall have the right to withhold its consent to any changes in vendors of Raw Materials in its sole discretion.
Process Change. Patheon shall pay for the supply of Raw Materials as may be necessary to Manufacture Product (including without limitation to package such materials) in accordance with this CSA and the Quality Agreement. Patheon shall use the Raw Materials delivered pursuant to orders placed under this CSA only for Manufacturing Product. The Price for Product shall include the purchase price of all Raw Materials (other than [***]) subject to Section 5.13 Raw Material Cost [***]. In addition the Price shall include the costs of transportation and freight expenses to the Facility and any associated taxes, duties, customs, insurance and fees for the export, import, carriage and transportation of all Raw Materials, all at Patheon’s actual cost, without any administrative fee or other xxxx up.
Process Change. If (a) Seller implements an ongoing process change at a Mill different from current operations that results in ongoing Negative Impacts of more than 25% of CTO volume from such Mill in any calendar quarter or (b) Buyer receives a Process Change Notice from Seller, then Buyer shall have the right to discontinue such purchases of such Product from such Mill, and Seller shall have the right to sell such Product to a third party until such time as the Negative Impacts are no longer occurring or the conditions described in the Process Change Notice is no longer in effect, as applicable, with no liability to Buyer under this Agreement or at law or in equity in connection with such process change. To the extent Seller is producing CTO at another mill location that meets the Specifications set forth herein, Seller shall supply CTO from such other mill location to the extent additional CTO (i) is available from such mill location and (ii) is not contractually committed to be sold to a third party. For the avoidance of doubt, to the extent that Seller sells CTO from other mill locations pursuant to the immediately preceding sentence, Seller shall supply such CTO, if any, (x) first to the extent of any volumes not contractually committed to be sold to a third party and (y) then, if necessary, additional volumes that become available for sale upon expiration or termination of such third-party contracts.
Process Change. Multiple Critical Risk Factors A production process change that requires multiple critical risk factors to be considered. An example includes a project that requires a process certification process to be successfully completed, but also include significant capital and/or implementation funding to be secured in order for implementation to proceed. The critical risk factors that should be considered in this category are Technical, PO/TWH Approval, Major Milestones or Go/No-Go Decision, Capital/Implementation Funding or Business Case Strength/Benefit factors.
