Supplier Requested Changes Sample Clauses

Supplier Requested Changes. Supplier shall notify Company of proposed changes to the Raw Material, Manufacturing Process, Manufacturing Site(s), or Specification(s) to the extent required to do so by the Quality Agreement. If change notification is required by the Quality Agreement, Company and Supplier shall first discuss what if any costs and/or benefit to the Company of a proposed change. Supplier shall supply Company with samples of Product(s) at no cost to Company which have undergone Manufacturing Process or Specification changes. Supplier shall continue to supply to Company the pre-change Product(s) then in effect, according to and consistent with the terms of this Agreement until approval to implement the proposed change is received by Supplier from Company. Without limiting the foregoing, Company agrees to implement the changes outlined below by making appropriate regulatory filings at Company’s expense in connection with: • *** • *** • *** With respect to the second bullet above, Company agrees to accept validated material ***. Should Company, in its sole discretion, warrant that the *** process is not suitable for its Finished Products, Company will be relieved of its obligations to purchase from Supplier, and Supplier shall be relieved of its obligation to supply *** as set forth in this Agreement and a mutually agreeable transition plan will be discussed. Supplier will provide commercially reasonable technical, analytical, and regulatory support, and the filing of changes with the FDA shall not be unreasonably withheld by Company.
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Supplier Requested Changes. NCR Confidential 2.2.1 If Supplier requests a change to a Product, Supplier will submit to NCR a written change request in a form and format determined by NCR. The request for change from Supplier must include at a minimum the following: (a) reason for change (e.g., availability of a part, cost reduction, and the like); (b) desired date of introduction; (c) detailed difference between the old and new Product process; (d) results of testing that support same or better resulting performance; (e) cost reduction effect (cost savings are expected); and (f) means of differentiating Products by identification number change, revision level change, or by some other means so that NCR and Designated Purchaser can readily discern the difference. NCR may evaluate the request itself or request a Designated Purchaser or the Supplier to make the evaluation on such criteria as NCR may in its sole discretion establish from time to time. All test and other evaluation results will be supplied to NCR in writing. NCR (or a Designated Purchaser) may approve or reject a requested change in its sole discretion. No change will be implemented absent NCR’s or its Designated Purchaser’s (determined on a case-by-case basis) approval. Changes that affect the form, fit, function, or performance of a Product will be tracked by a part number change. Supplier will maintain during the term of this Agreement and for 36 months after termination or expiration detailed records in English language for the Product serial number and or part number and cut-in dates for all changes. 2.2.2 In addition to Product Changes, Supplier will provide a minimum of sixty (60) days advance written notice of a requested change to the manufacturing process or methods, key personnel, or relocation of production to a different manufacturing facility after initial acceptance by NCR of the Products. This notice must include any change, additions, or deletions of any tests or assembly processes. NCR will notify Supplier whether it concurs with the proposed changes prior to Supplier’s implementation of any such requested change. 2.2.3 Supplier will provide a minimum of one hundred eighty (180) days advance written notice if Supplier plans to discontinue production of any Product (excluding Manufactured Product) or discontinue use of any Tooling (defined below). NCR will notify Supplier of the disposition of the Tooling. For avoidance of doubt, Supplier will not dispose of Tooling except as directed by NCR in writing by ...
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Supplier Requested Changes. 14.1 Both parties recognize that there may be optional changes proposed by SUPPLIER affecting form, fit or function which are not Mandatory Engineering Changes ("Optional Engineering Changes"). Optional Engineering Changes may also include changes in processes or materials. SUPPLIER shall provide EMC copies of all Engineering Change Notices affecting Form, Fit, Function (as defined below), active components, or reliability. SUPPLIER will also provide copies of Process Change Notification forms related to mutually agreed upon EMC specific manufacturing or test processes that would affect the following:
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Related to Supplier Requested Changes

  • 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.

  • 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.

  • Change Orders Any alteration or deviation from the Services mentioned or any other contractual specifications that result in a revision of this Agreement shall be executed and attached to this Agreement as a change order (“Change Order”).

  • Changes to Specifications All Specifications and any changes thereto agreed to by the parties from time to time shall be in writing, dated and signed by the parties. Any change to the Packaging process shall be deemed a Specification change. No change in the Specifications shall be implemented by PCI, whether requested by Client, requested by PCI or requested or required by any Regulatory Authority, until the parties have agreed in writing to such change, the implementation date of such change, and any increase or decrease in costs, expenses or fees associated with such change (including any change to Pricing). PCI shall respond promptly to any request made by Client for a change in the Specifications, and both parties shall use commercially reasonable, good faith efforts to agree to the terms of such change in a timely manner. As soon as possible after a request is made for any change in Specifications, PCI shall notify Client of the costs associated with such change and shall provide such supporting documentation as Client may reasonably require. Client shall pay all costs associated with such agreed upon changes. If there is a conflict between the terms of this Agreement and the terms of the Specifications, this Agreement shall control. PCI reserves the right to postpone effecting changes to the Specifications, or in the case of changes requested or required by any Regulatory Authority postpone Packaging under this Agreement, until such time as the parties agree to and execute the required written amendment.

  • Product Specifications The Company agrees that all Products sold to Xxxx hereunder shall conform to the respective specifications set forth on Schedule A or to such other specifications as are from time to time agreed upon by the Parties.

  • Technical Specifications The Technical Specifications furnished on the CD are intended to establish the standards for quality, performance and technical requirements for all labor, workmanship, material, methods and equipment necessary to complete the Work. When specifications and drawings are provided or referenced by the County, these are to be considered part of the Scope of Work, and to be specifically documented in the Detailed Scope of Work. For convenience, the County supplied specifications, if any, and the Technical Specifications furnished on the CD.

  • Change Order (5) The Change Order is then submitted to the Project Manager who immediately processes the CO with OPC as required by Bulletin 3.5 and BGS’ Contracting Plan.

  • APPROVAL OF PLANS AND SPECIFICATIONS The Plans and Specifications will conform to the requirements and conditions set out by applicable law or any effective restrictive covenant, and to all governmental authorities which exercise jurisdiction over the Leased Premises or the construction thereon.

  • Quality Specifications SANMINA-SCI shall comply with the quality specifications set forth in its Quality Manual, incorporated by reference herein, a copy of which is available from SANMINA-SCI upon request.

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