Instrument Specifications and Quality Standards Sample Clauses

Instrument Specifications and Quality Standards. The parties' objective is that Pilot Instruments will be manufactured to the same FDA QSR configuration control standards as Production Instruments. KMC shall use good workmanship in performing all Pilot Production Phase activities and the Pilot Instruments shall meet the applicable quality and regulatory requirements of Article VII. The parties acknowledge that the PRD will not have been finalized before KMC begins to assemble Pilot Instruments pursuant to the terms of this Article V. KMC shall use its best efforts to assemble the Pilot Instruments in accordance with the configuration of PR 30, as previously prescribed by Rela, together with those additional Design Engineering changes described in Exhibit 1; provided, also, that KMC shall use its best efforts to achieve modifications that may be adopted pursuant to the Scope Change provisions of Section 3.10. KMC shall advise Gen-Probe if KMC concludes that any Design Engineering change described in Exhibit 1 or any Scope Change cannot be incorporated into a Pilot Instrument, and in that event Gen-Probe will decide, in its sole discretion, whether to proceed with assembly of such Pilot Instrument. Gen-Probe may also, at its sole discretion, defer assembly of any Pilot Instrument if Gen-Probe concludes that such delay is appropriate in order to increase Instrument reliability prior to assembly of any Pilot Instrument. KMC shall develop, subject to Gen-Probe's review and approval (which approval or rejection shall be in its sole discretion), preliminary acceptance test procedures (the "Preliminary ATP") that each Pilot Instrument must pass before shipment by KMC.
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Instrument Specifications and Quality Standards. The parties acknowledge that the specifications for the Instrument have not been finalized by Gen-Probe. When it deems appropriate, Gen-Probe shall commence validation of the Instrument's design against its then-current specifications. After Gen-Probe is satisfied with the validation of the Instrument's design to such specifications, Gen-Probe shall issue the PRD for Production Instruments. Gen-Probe shall have full control, authority and responsibility for the design of the Instrument, including during the Design Engineering Phase, and for the final specifications of the Instrument. Upon finalization of the PRD, and based on the Instrument capabilities associated therewith, KMC *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. shall develop, subject to Gen-Probe's review and approval (which approval shall be in Gen-Probe's sole discretion), the acceptance test procedures (the "ATP") that each Production Instrument must pass before shipment by KMC. Subject to all of the terms and conditions of this Agreement (including, without limitation, necessary Scope Changes and issuance of related Work Statements), KMC shall: (i) complete the Instrument design to meet Gen-Probe's final specifications; (ii) develop the ATP to insure that each Production Instrument meets certain performance criteria to be agreed upon by the parties, reasonably and in good faith, after finalization of the PRD for Production Instruments; and (iii) manufacture Production Instruments that comply with and pass the entire ATP. The ATP will be summarized in a Gen-Probe Quality Control Specification ("QCS") document against which each Instrument will have a "Certificate of Release" provided to Gen-Probe upon shipment of each Instrument.

Related to Instrument Specifications and Quality Standards

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