Product Specifications; Modifications Clause Samples
The 'Product Specifications; Modifications' clause defines the standards and requirements that a product must meet, as well as the process for making changes to those specifications. Typically, this clause outlines how specifications are documented, who has the authority to request or approve modifications, and the procedures for implementing such changes, such as requiring written agreement or advance notice. Its core function is to ensure that both parties have a clear understanding of the product requirements and a structured method for handling any necessary adjustments, thereby minimizing misunderstandings and disputes over product quality or features.
Product Specifications; Modifications. Product specifications for the Initial Products as of the Effective Date are attached hereto as Appendix 2.3 and Product specifications for FACT and F1CDx as of the Restatement Date have been provided to Roche. FMI will develop product specifications for all other Products during development of each such Product. FMI will provide a copy of draft product specifications for such Products to Roche for such Products as such specifications are substantially completed, except for any specifications that incorporate Third Party proprietary or confidential information. FMI will provide a copy of any material modifications to any Product specifications (other than F1CDx) to Roche prior to such implementation. FMI shall consider in good faith any and all comments or concerns timely raised by Roche in connection with its review of such draft specifications or such modifications (in each case, excluding Third Party confidential information relating to F1CDx). FMI shall only be authorized to adopt modifications to the First Year Product specifications that result in a diminution to the analytical performance as measured by the metrics set forth in Appendix 2.3, either (i) with the prior written consent of Roche or (ii) without such consent if FMI has or is adopting the same modification to the specifications for the same Product as it has developed and commercialized in the US. In the event that clause (ii) above is applicable for an Initial Product, the JOC may reset the Minimum Revenue Requirement in such year in accordance with Section 7.4.1.2.
Product Specifications; Modifications. Product specifications for the Initial Products are attached hereto as Appendix 2.3. FMI will develop product specifications for all other Products during development of each such Product. FMI will provide a copy of draft product specifications to the JOC for all other Products as such specifications are substantially completed. FMI will provide a copy of any material modifications to any Product specifications to the JOC no less than […***…] prior to anticipated locking of the design file, unless such changes are reasonably required to be implemented on an expedited basis, for example, to maintain compliance with Applicable Laws or the requirements of any Regulatory Authority, in which case FMI shall provide such specifications to the JOC as far in advance of implementation as is reasonably practicable. FMI shall consider in good faith any and all comments or concerns timely raised by Roche in connection with its review of such draft specifications or such modifications. FMI has final authority to adopt specifications for the Products and modifications thereto, […***…].
Product Specifications; Modifications. Supplier shall not modify the Product as provided by Supplier or discontinue the manufacture or supply of any Product, in each case, without Suneva’s written consent.
Product Specifications; Modifications. The Specifications may be modified from time to time by written agreement signed by an authorized representative of each Party without the necessity of amending this Agreement. If such modifications alter Abbott's Standard Manufacturing Cost to manufacture any Product, Abbo▇▇ ▇▇▇▇▇ submit to Triangle a revised price for such Product which reflects such changes in Standard Manufacturing Cost and the adjusted price for such Product, pursuant to the provisions of Section 8.1. If such modification results in the requirement to reprocess and/or retest otherwise acceptable Product, any additional costs incurred by Abbott in such reprocessing and/or retesting shall be included in the pricing recalculation upon submission by Abbott of documentation of such costs. The revised Specifications shall not become effective until the parties agree on any price recalculation caused by such modified specifications.