Process Deviations Sample Clauses

Process Deviations. 3.1.1. Any major unplanned deviations in manufacture (including non-conforming test results) discovered by Ash Sxxxxxx shall be reported to “Company’s” Quality Representative within five (5) business days after the discovery thereof. Ash Sxxxxxx will provide documentation to “Company’s” Quality Representative of all major deviations. “Company” will make every reasonable effort to review a temporary change request or quality deviation within five (5) business days, either giving approval or disapproval to proceed to Ash Sxxxxxx or requisitioning additional information and/or a joint investigation. “Company” QA will review all deviations as part of the release process. The resolutions of the deviations must be approved jointly by Ash Sxxxxxx’ and “Company’s” Quality Representatives. SUPPLY AGREEMENT
Sample 1
AutoNDA by SimpleDocs
Process Deviations. Any major unplanned deviations in Manufacture learned by CBSI after occurrence at the CBSI facilities shall be reported to Centocor's Authorized Quality Representative immediately. This includes non-conforming test results. CBSI will provide Centocor's Authorized Quality Representative a copy of all major deviations immediately via facsimile. Centocor will make every reasonable effort to review a temporary change request or quality deviation within five working days, either giving approval or disapproval to proceed to CBSI or requesting additional information. Centocor QA will review all deviations as part of the release process. The resolutions of the deviations must be approved by Centocor's Authorized Quality Representatives.
Sample 1

Related to Process Deviations

  • Deviations A written authorization, granted after contract award and prior to the manufacture of the item, to depart from a particular performance or design requirement of a contract, specification, or referenced document, for a specific number of units or a specified period of time. Deviations are intended only as one-time departures from an established configuration for specified items or lots and are not intended to be repeatedly used in place of formal engineering changes. BATC shall devise a system to control, monitor, and notify DigitalGlobe of these changes. The control system shall include provision for:

  • Technical Specifications Each Bloom System is an integrated system comprised of a fuel cell stack assembly and associated balance of plant components that converts a fuel into electricity using electrochemical means that (i) has a Nameplate Capacity of at least 0.5 kilowatts of electricity using an electrochemical process and (ii) has an electricity-only generation efficiency greater than thirty percent (30%).

  • Changes to Specifications All Specifications and any changes thereto agreed to by the parties from time to time shall be in writing, dated and signed by the parties. Any change to the Process shall be deemed a Specification change. No change in the Specifications shall be implemented by Catalent, whether requested by Client or requested or required by any Regulatory Authority, until the parties have agreed in writing to such change, the implementation date of such change, and any increase or decrease in costs, expenses or fees associated with such change (including any change to Unit Pricing). Catalent shall respond promptly to any request made by Client for a change in the Specifications, and both parties shall use commercially reasonable, good faith efforts to agree to the terms of such change in a timely manner. As soon as possible after a request is made for any change in Specifications, Catalent shall notify Client of the costs associated with such change and shall provide such supporting documentation as Client may reasonably require. Client shall pay all costs associated with such agreed upon changes. If there is a conflict between the terms of this Agreement and the terms of the Specifications, this Agreement shall control. Catalent reserves the right to postpone effecting changes to the Specifications until such time as the parties agree to and execute the required written amendment.

  • Manufacturing Intrexon shall have the option and, in the event it so elects, shall use Diligent Efforts, to perform any manufacturing activities in connection with the Aquaculture Program that relate to the Intrexon Materials, including through the use of a suitable Third Party contract manufacturer. To the extent that Intrexon so elects, Intrexon may request that AquaBounty and Intrexon establish and execute a separate manufacturing and supply agreement, which agreement will establish and govern the production, quality assurance, and regulatory activities associated with manufacture of Intrexon Materials. Except as provided in Section 4.1, any manufacturing undertaken by Intrexon pursuant to the preceding sentence shall be performed in exchange for cash payments equal to Intrexon’s Fully Loaded Cost in connection with such manufacturing, on terms to be negotiated by the Parties in good faith. In the event that Intrexon does not manufacture Intrexon Materials or bulk quantities of other components of AquaBounty Products, then Intrexon shall provide to AquaBounty or a contract manufacturer selected by AquaBounty and approved by Intrexon (such approval not to be unreasonably withheld) all Information Controlled by Intrexon that is (a) related to the manufacturing of such Intrexon Materials or bulk qualities of other components of AquaBounty Products for use in the Field and (b) reasonably necessary to enable AquaBounty or such contract manufacturer (as appropriate) for the sole purpose of manufacturing such Intrexon Materials or bulk quantities of other components of AquaBounty Products. The costs and expenses incurred by Intrexon in carrying out such transfer shall be borne by Intrexon. Any manufacturing Information transferred hereunder to AquaBounty or its contract manufacturer shall not be further transferred to any Third Party, including any Product Sublicensee, or any AquaBounty Affiliate without the prior written consent of Intrexon; provided, however, that Intrexon shall not unreasonably withhold such consent if necessary to permit AquaBounty to switch manufacturers.

  • Specifications Shipper will ensure that all of its Products tendered at the Origin Point for transportation on the Pipeline System meet the applicable specifications for the Product as set forth in the Tariff (as defined below) (the “Specifications”).

  • Packaging and Labeling 11.1 Company shall provide packaging and labeling specifications that call out clear labeling requirements.

  • Quality Specifications SANMINA-SCI shall comply with the quality specifications set forth in its Quality Manual, incorporated by reference herein, a copy of which is available from SANMINA-SCI upon request.

  • Forecasting Manager and Sprint PCS will work cooperatively to generate mutually acceptable forecasts of important business metrics including traffic volumes, handset sales, subscribers and Collected Revenues for the Sprint PCS Products and Services. The forecasts are for planning purposes only and do not constitute Manager's obligation to meet the quantities forecast.

  • Reverse Engineering The Licensee shall not reverse engineer, decompile or disassemble the object code version of the Computer Program without the prior written approval of the Licensor.

  • Investment Analysis and Implementation In carrying out its obligations under Section 1 hereof, the Advisor shall:

Time is Money Join Law Insider Premium to draft better contracts faster.