Process Change Sample Clauses

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.
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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.
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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.
Sample 1
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.
Sample 1
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.
Sample 1
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.
Sample 1
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.
Sample 1
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Related to Process Change

  • Product Changes Vocera shall have the right, in its absolute discretion, without liability to End User, to update to provide new functionality or otherwise change the design of any Product or to discontinue the manufacture or sale of any Product. Vocera shall notify End User at least 90 days prior to the delivery of any Product which incorporates a change that adversely affects form, fit or function (“Material Change”). Vocera shall also notify End User at least 90 days prior to the discontinuance of manufacture of any Product. Notification will be made as soon as reasonably practical for changes associated with regulatory or health and safety issues.

  • Benchmark Replacement Conforming Changes In connection with the use, administration, adoption or implementation of a Benchmark Replacement, the Administrative Agent will have the right to make Conforming Changes from time to time and, notwithstanding anything to the contrary herein or in any other Loan Document, any amendments implementing such Conforming Changes will become effective without any further action or consent of any other party to this Agreement or any other Loan Document.

  • Specification Changes Upon any change in the Product Specifications, stability protocols, QC laboratory methods raw material specification or Packaging Specifications (whether initiated by Horizon or made in response to a request by sanofi-aventis that is agreed to by Horizon), including the addition of new packaging configurations, new SKUs, new formulations, or a change in either raw materials or Packaging Component supply, Horizon shall promptly advise sanofi-aventis in writing of such changes, and sanofi-aventis shall promptly advise Horizon as to any scheduling and/or price adjustments which may result from such changes. Prior to implementation of such changes, the Parties shall negotiate in good faith in an attempt to reach agreement on (a) the new Product Price for any Product which embodies such changes, (b) any amounts to be reimbursed by Horizon to sanofi-aventis as described in the next sentence of this paragraph, and (c) any other amendments to this Agreement which may be necessitated by such changes (i.e., an adjustment to the lead time for purchase orders). Horizon shall reimburse sanofi-aventis for the mutually agreed upon reasonable expenses incurred by sanofi-aventis as a result of such changes, including, but not limited to, reimbursing sanofi-aventis for its mutually agreed validation and development costs, capital expenditure costs, costs for any Packaging Components or other materials rendered unusable as a result of such changes, and cost of required stability to support a change. If during the Term Horizon amends the Product Specifications or Packaging ***Confidential Treatment Requested MANUFACTURING AND SUPPLY AGREEMENT PAGE 7 Specifications (whether voluntarily or as required by law) so as to render obsolete quantities of the Active Ingredient, Excipients and/or Packaging Components for the Product on hand at sanofi-aventis, Horizon shall (i) accept the return of all such obsolete Active Ingredient and (ii) purchase from sanofi-aventis, at sanofi-aventis’ Acquisition Cost, all such obsolete Excipients and Packaging Components obtained by sanofi-aventis pursuant to its normal procurement policies to manufacture quantities of the Product pursuant to Horizon forecasts under Section 6.1. Sanofi-aventis’ normal procurement policies for purposes of the preceding sentence of this Article 5 shall be considered to be quantities of Excipients and Packaging Components corresponding to the immediately following […***…] months of Horizon’s most recent forecasted Product demand. If a change in Specifications is initiated by sanofi-aventis and approved by Horizon, any cost associated with said change shall be borne by sanofi-aventis. In the event that a change in Specifications is initiated by Horizon or driven by a regulatory or business change, the costs associated with qualification of the change shall be paid by Horizon. The amount of the change shall be reasonable and customary and subject to written approval by Horizon, such approval not to be unreasonably withheld. Sanofi-aventis, with written agreement and approval from Horizon, will be responsible for the appropriate (cGMP) destruction of any materials covered under this Article 5, and sanofi-aventis shall be reimbursed by Horizon at the reasonable and customary approved rate.

  • Business Changes Change in any material respect the nature of the business of the Borrower or its Subsidiaries as conducted on the Effective Date.

  • Engineering Changes Customer may request that Flextronics incorporate engineering changes into the Product by providing Flextronics with a description of the proposed engineering change sufficient to permit Flextronics to evaluate its feasibility and cost. Flextronics will proceed with engineering changes when the parties have agreed upon the changes to the Specifications, delivery schedule and Product pricing and the Customer has issued a purchase order for the implementation costs.

  • Term SOFR Conforming Changes In connection with the use or administration of Term SOFR, the Administrative Agent will have the right to make Conforming Changes from time to time and, notwithstanding anything to the contrary herein or in any other Loan Document, any amendments implementing such Conforming Changes will become effective without any further action or consent of any other party to this Agreement or any other Loan Document. The Administrative Agent will promptly notify the Borrower and the Lenders of the effectiveness of any Conforming Changes in connection with the use or administration of Term SOFR.

  • Change of Name or Location; Change of Fiscal Year Such Grantor shall not (a) change its name as it appears in its organizational documents and as filed in such Grantor’s jurisdiction of organization, (b) change its chief executive office, principal place of business, mailing address or corporate offices or change or add warehouses or locations at which Collateral is held or stored, or the location of its records concerning the Collateral, in each case from the locations identified on Exhibit A, (c) change the type of entity that it is, (d) change its organization identification number, if any, issued by its state of incorporation or other organization, or (e) change its state of incorporation or organization, in each case, unless the Administrative Agent shall have received at least fifteen days (or such lesser period of time as the Administrative Agent may agree) prior written notice of such change and the Administrative Agent shall have acknowledged in writing that either (1) such change will not adversely affect the validity, perfection or priority of the Administrative Agent’s security interest in the Collateral, or (2) any reasonable action requested by the Administrative Agent in connection therewith has been completed or taken (including any action to continue the perfection of any Liens in favor of the Administrative Agent, on behalf of Lenders, in any Collateral), provided that, any new location shall be in the continental U.S. Such Grantor shall not change its fiscal year except as permitted under the Credit Agreement.

  • Election Changes The Executive may modify the amount of Deferrals annually by filing a new Deferral Election Form with the Employer. The modified deferral shall not be effective until the calendar year following the year in which the subsequent Deferral Election Form is received by the Employer.

  • Interim Changes Except as set forth on Schedule 4.4, since December 31, 2006, there has been no:

  • Acceptance Testing At the time of installation of a LIS trunk group, and at no additional charge, acceptance tests will be performed to ensure that the service is operational and meets the applicable technical parameters.

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