Specification Changes Clause Samples
The Specification Changes clause defines the process by which modifications to the project's technical or functional requirements can be proposed, reviewed, and implemented. Typically, this clause outlines who has the authority to request changes, the procedures for evaluating their impact on cost, timeline, or deliverables, and the method for documenting and approving such changes. Its core function is to provide a structured mechanism for managing adjustments to the original specifications, thereby minimizing disputes and ensuring that all parties remain aligned as project needs evolve.
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Specification Changes. (a) During the Term, GSK will accept a labeling change from Prometheus as contemplated by this Section 4.2 but otherwise the Parties acknowledge and agree that GSK does not intend to make any material changes (such as packaging design, manufacturing process or similar or related changes) to the existing Product during the Term.
(b) Either Party may request a Specifications change intended to maintain high standards but that are not required for compliance with Regulatory Acts and Applicable Laws. The Parties shall discuss in good faith the implementation of any such requested changes; provided however, that, such changes shall be made only with the Parties' mutual consent. Either Party may provide notice to the other Party regarding a Specifications change required for compliance with Regulatory Acts and Applicable Laws, and the other Party's approval of such Specification change shall not be unreasonably withheld; provided, however, if there are two or more alternatives for complying with the change in Regulatory Acts and Applicable Laws, each of which GSK believes, in its sole discretion, it can implement on a product-by-product basis without undue burden to GSK's overall manufacturing operations, then Prometheus shall have the right to choose which of such alternatives shall be implemented. The costs for changes to the Specifications under this Section 4.2(b) shall be borne as described in Sections 3.1(f) and 3.1(g), as applicable.
(c) GSK shall not make any revisions to the Specifications without prior written consent of Prometheus in accordance with the Quality Agreement. All requests by GSK for such revisions shall be submitted in writing to Prometheus on the forms included in the Quality Agreement.
(d) (i) General. From time to time Prometheus or GSK may require labeling or artwork changes that will affect the Products. These changes may either be initiated by Prometheus or GSK or may be a requirement resulting from cGMPs changes. Responsibility for the cost of all such labeling or artwork changes under this Section 4.2(d) shall be borne as described in Section 3.1.
Specification Changes. Changes to specifications are made by mutual agreement between the Supplier and the Customer. In addition to agreement of the change, the Supplier and Customer will determine the effective date of the change. Changes will be coordinated, initial production will be identified and where applicable PPAP’d to the customer. When the specifications include references to brand names, the Supplier and Customer will mutually agree on the implementation of any changes made in the brand name of the product.
Specification Changes. In the event that the Seller incurs additional expense because of changes in specifications or drawings previously approved by the Buyer, or in the event that the Seller is required to modify the ordered Products, perform any additional Services, perform any additional work or supply any additional Products, the additional expense shall be added to the purchase price. The Seller shall have the right, in its sole discretion, to accept or reject any changes in specifications requested by the Buyer. In no event shall any changes in specifications be made or accepted thirty (30) days prior to delivery date or thereafter.
Specification Changes. Supplier may not change the form, fit, or function of any Product, or its manufacturing process or manufacturing location, without Seagate’s prior written approval. Seagate may change the Specifications at any time. Supplier will use commercially reasonable best efforts to comply with the changes. If Supplier believes that a change will require an adjustment in Supplier’s costs or time for performance, then Supplier must request the adjustment in writing within three weeks of receiving Seagate’s change notice. Supplier shall not be required to implement the change until the Parties have agreed on revised terms.
Specification Changes. In the event that ORPHAN wishes to change the Specifications, or in the event that ORPHAN is required to change the Specifications pursuant to applicable law or regulation or in response to the order or request of a governmental authority or regulatory body, the following provisions will apply. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
(1) ORPHAN shall promptly advise Catalytica in writing of any such change(s) to the Specifications, and Catalytica shall promptly advise ORPHAN as to any scheduling and/or Product Price adjustments which may result from any such change(s), if any. The notification and approval procedure shall be in accordance with APPENDIX F, as well as any additional standard operating procedures (i.e., change control procedures) agreed upon by ORPHAN and Catalytica in writing from time to time.
(2) Prior to implementation of such change(s) to the Specifications, ORPHAN and Catalytica shall negotiate in good faith in an attempt to reach agreement on (i) the new Product Price, if any, for any Drug Product and/or Finished Product provided hereunder by Catalytica which embodies such change(s) to the Specifications, giving due consideration to the effect of such change(s) on Catalytica’s manufacturing costs for Drug Product and/or Finished Product and (ii) any other amendments to this Agreement which may be necessitated by such changes (e.g., an adjustment to the lead time for Firm Orders). Implementation of such change(s) to the Specifications shall be as set forth in APPENDIX F.
(3) ORPHAN will reimburse Catalytica for the reasonable and necessary expenses incurred by Catalytica as a result of any such change(s) to the Specifications [ * ].
(4) If any such change(s) to the Specifications renders obsolete or unusable any materials or components for Drug Product or Finished Product, and to the extent such materials or components may not be returned to the appropriate vendor for a credit [ * ] that amount of inventory of materials or components, as the case may be, so rendered obsolete or unusable, not to exceed the amount of such materials or components which would have been required for [ * ]. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COM...
Specification Changes. Supplier reserves the right to change the Specifications by written notice to Distributor.
Specification Changes. SMI shall not make any change to the Modified Starch (including materials, packaging, and directions for use), Modified Starch Specifications, the raw materials, suppliers of starch, manufacturing process for the Modified Starch or the Products Specifications (collectively, “Specification Changes”), unless approved by CryoLife in writing in advance, which approval may not be unreasonably denied (with the Parties understanding that any such changes that would require new, or change to any Regulatory Approval may be denied by CryoLife due to the cost or time involved in that change).
4.2.1 Without limiting the foregoing, all Specification Changes (including changes required by law) shall be submitted to CryoLife in writing no later than one hundred eighty (180) days prior to SMI’s proposed date of implementation for such change. Unless CryoLife notifies SMI in writing that it disapproves of such change during the thirty (30) calendar day period following the notification of such change or if such a proposed change is otherwise required by law, regulation, or directive, SMI shall be authorized to implement such change and shall be responsible for properly communicating and implementing such change, including with respect to any of SMI’s vendors.
4.2.2 Without limiting the foregoing, the following changes shall be deemed governed by this Section: (i) use of any nonconforming material in the Manufacturing of the Modified Starch in variance with the Modified Starch Specifications or the Products Specifications; (ii) implementation of any deviation that could affect the handling, sterility, safety, or efficacy of any of the Modified Starch or the Products or be at variance with the Modified Starch Specifications or the Products Specifications; or (iii) implementation of any corrective action that could affect the safety or efficacy of the Modified Starch or the Products. Notwithstanding the foregoing, SMI shall not make any Specification Changes that disqualify Products for sale under any Regulatory Approval respecting the Products within any portion of the Territory.
4.2.3 SMI shall be responsible for all costs and expenses associated with developing and implementing any Specification Changes including, without limitation, any and all cost associated with obtaining regulatory approval to incorporate Specification Changes into Products or to Manufacture or Distribute Products that incorporate Specification Changes throughout the Territory.
Specification Changes. If either party desires a change to the Specifications, it shall notify the other party of such desired change and the reasons therefor, including supporting materials, data or reports, if any. The parties agree to negotiate such changes in good faith. If the parties are unable to agree on requested revisions to the Specifications either party may initiate the dispute resolution procedures set forth in Section 15.k; provided, however, that in case of an emergency IQE may make such major process change without prior notice to RFMD if such changes do not impact fit, form or function, but shall notify RFMD of such change promptly thereafter.
Specification Changes. Supplier shall have the right to make changes to the Specifications from time to time, and shall notify Customer thereof in advance no less than three (3) months prior to the first delivery to Customer of API implementing such change(s). Supplier shall first obtain Customer’s prior written consent to any such change (other than a change required by a Regulatory Authority) that would affect Customer’s then pending Regulatory Filing(s) or in-process pre-marketing clinical trial for a Recro Product. Following grant of Regulatory Approval, Supplier shall first obtain Customer’s prior written consent to any such changes (other than a change required by a Regulatory Authority) that would affect Customer’s Regulatory Approval(s), such consent not to be unreasonably withheld. Customer recognizes that change may be necessary to enable Supplier to remain efficient and cost-effective and thus shall be fully supportive of the implementation of such changes where justified.
Specification Changes. FIBERSTARS and VLI anticipate that it may be desirable during the term of this Agreement to amend the Product Specifications. Such amendments to the Product Specifications shall be made by mutual agreement of VLI and FIBERSTARS. If such Product Specification changes require or allow a change in pricing, such pricing changes shall be by mutual agreement and shall be reflected in a revision to Exhibit C pursuant to an amendment to this Agreement.