Common use of Implementation of Optional Improvements Clause in Contracts

Implementation of Optional Improvements. In evaluating and implementing Optional Improvements, Supplier shall use commercially reasonable efforts to minimize SI-BONE’s cost of implementing the Optional Improvements. Supplier shall provide SI-BONE with a detailed analysis (together with supporting documentation) of the estimated costs (if any) and effect on the supply [*] = 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. price for the applicable Product (if any) of implementing such Optional Improvement. Supplier shall implement such Optional Improvement only with SI-BONE’s prior written consent. If Supplier notifies SI-BONE that implementation of an Optional Improvement will require any modification to the pricing set forth on the Pricing Addendum or in the applicable Order and SI-BONE agrees, the parties will negotiate in good faith an appropriate modification to the pricing in an amendment to this Agreement. If the parties are unable to agree on the change in pricing, then Supplier may delay implementation of the Optional Improvement until a reasonable price change is agreed; provided, however, that if the parties are unable to agree on such reasonable change in pricing, SI-BONE will have the option of terminating this Agreement provided that this termination will not relieve SI-BONE of its obligations with respect to any open Orders or outstanding payments. All such improvements shall be evaluated and implemented in accordance with SI-BONE’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 and Device Master Record, as applicable, and provide copies of such documentation to SI-BONE upon implementation of the Optional Improvement. To the extent that Supplier provides input on Optional 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.

Appears in 2 contracts

Samples: Manufacturing, Quality and Supply Agreement (SI-BONE, Inc.), Manufacturing, Quality and Supply Agreement (SI-BONE, Inc.)

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Implementation of Optional Improvements. In evaluating and implementing Optional Improvements, Supplier shall use commercially reasonable efforts to minimize SI-BONE’s the cost of implementing the Optional Improvements. Supplier shall provide SI-BONE Company with a detailed analysis (together with supporting documentation) of the estimated costs (if any) and effect on the supply [*] = 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. price for the applicable Product (if any) of implementing such Optional Improvement. Supplier shall implement such Optional Improvement only with SI-BONECompany’s prior written consent. If Supplier notifies SI-BONE Company that implementation of an Optional Improvement will require any modification to the pricing set forth on the Pricing Addendum or in the applicable Order Exhibit’s A through D, as revised from time to time, and SI-BONE Company agrees, the parties will negotiate in good faith an appropriate modification to the pricing in an amendment to this Agreement. If Supplier does not notify Company that it will implement an Optional Improvement within 30 days after REV 08/2023 CONFIDENTIAL AND PROPRIETARY receiving notice of an Optional Improvement from Company or the parties are unable to cannot agree on the change in updated pricing, then Supplier Company may delay implementation of obtain the Product with the Optional Improvement until a reasonable price change is agreed; providedincorporated therein from an Alternative Source or manufacture it in-house, however, that if the parties are unable in either case without any liability to agree on such reasonable change in pricing, SI-BONE will have the option of terminating this Agreement provided that this termination will not relieve SI-BONE of its obligations with respect to any open Orders or outstanding paymentsSupplier hereunder. All such improvements shall be evaluated and implemented in accordance with SI-BONECompany’s applicable design control Design Control processes and procedures that are in effect at the time that the improvements are made. Supplier shall update the Design History File and File, Device Master Record, provide first article inspection (“FAI”) samples and first article inspection report, as applicable, and provide copies of such documentation to SI-BONE Company upon implementation of the Optional Improvement. To the extent that Supplier provides input on Optional 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.

Appears in 1 contract

Samples: Manufacture and Supply Agreement (SI-BONE, Inc.)

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Implementation of Optional Improvements. In evaluating and implementing Optional Improvements, Supplier shall use commercially reasonable efforts to minimize SI-BONE’s cost of implementing the Optional Improvements. Supplier shall provide SI-BONE with a detailed analysis (together with supporting documentation) of the estimated costs (if any) and effect on the supply [*] = 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. price for the applicable Product (if any) of implementing such Optional Improvement. Supplier shall implement such Optional Improvement only with SI-BONE’s prior written consent. If Supplier notifies SI-BONE that implementation of an Optional Improvement will require any modification to the pricing set forth on the Pricing Addendum or in the applicable Order and SI-BONE agrees, the parties will negotiate in good faith an appropriate modification to the pricing in an amendment to this Agreement. If the parties are unable to agree on the change in pricing, then Supplier may delay implementation of the Optional Improvement until a reasonable price change is agreed; provided, however, that if the parties are unable to agree on such reasonable change in pricing, SI-BONE will have the option of terminating this Agreement provided that this termination will not relieve SI-BONE of its obligations with respect to any open Orders or outstanding payments. All such improvements shall be evaluated and implemented in accordance with SI-BONE’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 and Device Master Record, as applicable, and provide copies of such documentation to SI-BONE upon implementation of the Optional Improvement. To the extent that Supplier provides input on [*] = Certain confidential information contained in this document, marked by brackets, is omitted because it is both (i) not material and (ii) is the type of information that SI-BONE, Inc. treats as private or confidential. CONFIDENTIAL & PROPRIETARY Exhibit 10.4 Optional 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.

Appears in 1 contract

Samples: Manufacturing, Quality and Supply Agreement (SI-BONE, Inc.)

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