Implementation of Required Improvements. Immediately following receipt of such a request from SI-BONE regarding a Required Improvement, Supplier shall use best efforts to implement the Required Improvement as soon as possible at SI-BONE’s sole cost and shall provide reports regarding Supplier’s implementation progress to SI-BONE upon SI-BONE’s request. All such improvements shall be evaluated and implemented in accordance SI-BONE’s applicable design control processes and procedures that are in effect at the time that the improvements are made. SI-BONE shall update the Design History File and Device Master Record, as applicable, and provide copies of such documentation to SI-BONE upon implementation of the Required Improvement. To the extent that Supplier provides input on Required Improvements and changes to the Specifications, it is understood by the parties that such activity does not intend to make Supplier a “Specifications Developer” or a “finished device manufacturer” as such terms are used by FDA. Supplier will have the right to reasonably adjust the Product price to the extent that the changes requested by SI-BONE affect the material, manufacturing or quality costs. In the event that any Required Improvements result in a change in costs to Supplier, the parties shall negotiate in good faith a pricing change commensurate with the change in costs. If the parties are unable to agree on the change in pricing, then either of the parties may terminate this Agreement provided that, if the Supplier terminates the Agreement, SI-BONE will have the option of making Last Purchase per Section 9.5.
Implementation of Required Improvements. The Parties agree to work in good faith immediately upon the identification by either Party of a potential Required Improvement to find the most cost-effective solution. The Parties further acknowledge that Lubrizol’s technical expertise shall be given priority in evaluating potential Required Improvements and determining the optimal solutions. Lubrizol agrees to implement as soon as possible any Required Improvement that Braeburn reports to Lubrizol as necessary to obtain or maintain Regulatory Approval for an IDDS Product, provided that Braeburn bears all costs for improvements that require manufacturing processes that exceed GMP, consistent with Section 3.1. Lubrizol shall provide reasonable reports regarding Lubrizol’s implementation progress to Braeburn upon Braeburn’s request. Lubrizol shall update the DMF and the Module 3 Information and provide copies of such documentation to Braeburn upon implementation of the Required Improvement. CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
Implementation of Required Improvements. Upon agreement by the parties that (a) the Required Improvement is feasible, and (b) any changes to the price are agreed, the Company may request that the Supplier implement the Required Improvement and upon receipt of such a request from Company, Supplier shall use best efforts to implement the Required Improvement as soon as possible. All such improvements shall be evaluated and implemented in accordance with Company’s applicable Design Control processes and procedures that are in effect at the time that the improvements are made. Supplier shall update the Design History File, Device Master Record, provide first article inspection (“FAI”) samples and first article inspection report, as applicable, and provide copies of such documentation to Company upon implementation of the Required Improvement and if required, the parties will incorporate the new Pricing in Exhibit’s A through D as an amendment to this Agreement. To the extent that Supplier provides input on Required Improvements and changes to the Specifications, it is understood by the parties that such activity does not intend to make Supplier a “Specifications Developer” or a “finished device manufacturer” as such terms are used by FDA.
