Manufacturing Process Changes Sample Clauses

Manufacturing Process Changes. Without limiting Section 5.6(a), each Party shall comply with the applicable Quality Agreement with respect to the change control process to be followed if either Alkermes or Recro desires to change the Manufacturing process or DMF, including the Specifications, or if any applicable Regulatory Authority requires that the Manufacturing process, DMF or the Specifications be changed.
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Manufacturing Process Changes. Manufacturing and Release Requirements cannot be changed unless agreed to in a dated, written document signed by the Parties and incorporated into the Production Record. In addition, if any Regulatory Agency having jurisdiction in any country where SERAGEN is selling First Gen FDP and/or Second Gen FDP requires any changes to the Fermentation Pellets, First Gen PDS and/or Second Gen PDS Specifications, ***Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. CBSH shall make reasonable efforts to make the required changes per section 3.02, so long as such changes do not conflict with cGMP. In the event amendments or supplements are required to the Specifications for the purpose of complying with current Regulatory Requirements, the Parties shall mutually agree on appropriate amendments or supplements and shall incorporate or include such amendment or supplement in or as part of the Production Record. Such activities shall be additional services if they are requested by SERAGEN (i) in connection with the manufacture and testing of Fermentation Pellets, First Gen PDS, Second Gen PDS, First Gen FDP and/or Second Gen FDP or (ii) to comply with the Regulatory Requirements of a Regulatory Agency, and will be performed in accordance with the Additional Services rates set forth in Exhibit "B".
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Manufacturing Process Changes. Sulzer Carbomedics will have the right to change any of the processes by which it manufactures Components furnished to the Specifications, as it deems necessary or desirable. Sulzer Carbomedics will notify Manufacturer in writing, and obtain the written approval of Manufacturer before implementing any change which affects the biocompatibility or mechanical properties of the Pyrolite(R) coating on the Components. However, Sulzer Carbomedics may implement a change to any of its manufacturing and inspection processes without notifying or obtaining the consent of Manufacturer if that change does not affect the biocompatibility or mechanical properties of the Pyrolite(R) coating on the Components.
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Manufacturing Process Changes. The Quality Agreement will establish a change control process to be followed if either Alkermes or Amylin desires to change the DMF, including the Specifications, or if any applicable Regulatory Authority requires that the DMF or the Specifications be changed.
Sample 1
Manufacturing Process Changes. In the event that Amylin, Alkermes or any applicable Regulatory Authority desires or requires any change to be made to the DMF, including the Specifications, subject to the provisions set forth in Section 3.15 hereof, Amylin will pay Alkermes at the Manufacturing FTE Hourly Rate for all work performed by Alkermes personnel in implementing changes. Amylin will also reimburse Alkermes for any payments made for Third Person services and for materials and equipment in connection with the implementation of such changes. At the end of each Calendar Quarter during the period such * ***Confidential Treatment Requested work is being performed by Alkermes, Alkermes will invoice Amylin in U.S. Dollars for any such work that has been performed during such Calendar Quarter and any costs that Alkermes has incurred, and Amylin will pay all such invoices within [*…***…] of the invoice date. Invoices will set forth the number of hours worked by Alkermes personnel during such Calendar Quarter and the costs incurred for Third-Person services, materials and equipment, and will contain an appropriate description of such Third-Person services, materials and equipment. Invoices shall be emailed to Xxxxxxxx.Xxxxxxx@xxxxxx.xxx, with a copy to the Amylin lead member of the Site Management Team.
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Manufacturing Process Changes. Transmeta will provide at least [* * *] written notice of any modification to manufacturing process for the Contract Product, unless such modification results from safety issues, law or regulation, liability concerns, or actual or potential infringement issues, in which case Transmeta will provide notice immediately. Transmeta shall use commercially reasonable efforts to provide appropriate reliability data associated with such a change.
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Manufacturing Process Changes. Manufacturing process changes are expected to take place during the manufacturing lifecycle of CUSTOMER’s Product(s) in order to improve production efficiency, increase yield and reduce process costs. Ryder shall be responsible for the management and continuous improvement of the manufacturing processes used to manufacture CUSTOMER’S product. Ryder shall make best efforts to inform customer of its manufacturing processes, including changes and the supply of work instructions to customer or its agents when requested. CUSTOMER and its specified agents may make suggestions for process improvements. Ryder shall be responsible for the internal tracking of when processes changes are implemented and be capable of notifying CUSTOMER of the dates and / or serial numbers upon which process changes were implemented.
Sample 1
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Manufacturing Process Changes. Prior to implementing any material change to its manufacturing processes for Chips, AFFX shall give notice to RMS of sufficient details of the planned change to allow RMS to consider the impact of such change on regulatory requirements for the Products associated with such Chips. The Executive Steering Committee shall determine how such changes can be made to minimize such regulatory impact, and AFFX shall endeavor to accommodate input from the Executive Steering Committee and RMS to achieve the changes with minimum regulatory impact.
Sample 1

Related to Manufacturing Process Changes

  • Product Changes Vocera shall have the right, in its absolute discretion, without liability to End User, to update to provide new functionality or otherwise change the design of any Product or to discontinue the manufacture or sale of any Product. Vocera shall notify End User at least 90 days prior to the delivery of any Product which incorporates a change that adversely affects form, fit or function (“Material Change”). Vocera shall also notify End User at least 90 days prior to the discontinuance of manufacture of any Product. Notification will be made as soon as reasonably practical for changes associated with regulatory or health and safety issues.

  • Product Specifications The Company agrees that all Products sold to Xxxx hereunder shall conform to the respective specifications set forth on Schedule A or to such other specifications as are from time to time agreed upon by the Parties.

  • Manufacturing (a) The Supplier shall without limitation be responsible, at no additional cost to the Purchaser, for: sourcing and procuring all raw materials for the Products; obtaining all necessary approvals, permits and licenses for the manufacturing of the Products; providing sufficient qualified staff and workers to perform the obligations under this Purchase Agreement; implementing and maintaining effective inventory and production control procedures with respect to the Products; and handling other matters as reasonably requested by the Purchaser from time to time.

  • Manufacturing Services Jabil will manufacture the Product in accordance with the Specifications and any applicable Build Schedules. Jabil will reply to each proposed Build Schedule that is submitted in accordance with the terms of this Agreement by notifying Company of its acceptance or rejection within three (3) business days of receipt of any proposed Build Schedule. In the event of Jabil’s rejection of a proposed Build Schedule, Jabil’s notice of rejection will specify the basis for such rejection. When requested by Company, and subject to appropriate fee and cost adjustments, Jabil will provide Additional Services for existing or future Product manufactured by Jabil. Company shall be solely responsible for the sufficiency and adequacy of the Specifications [***].

  • 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.

  • SHOP DRAWINGS, PRODUCT DATA AND SAMPLES 4.12.1 Shop Drawings are drawings, diagrams, schedules and other, data specially prepared for the Work by the Contractor or any Subcontractor, manufacturer, supplier or distributor to illustrate some portion of the Work.

  • Supply of Materials The following materials will be supplied by the department Name of Materials Rate. Place of delivery 1.

  • Purchase Order Pricing/Product Deviation If a deviation of pricing/product on a Purchase Order or contract modification occurs between the Vendor and the TIPS Member, TIPS must be notified within five (5) business days of receipt of change order. Termination for Convenience of TIPS Agreement Only TIPS reserves the right to terminate this agreement for cause or no cause for convenience with a thirty (30) days prior written notice. Termination for convenience is conditionally required under Federal Regulations 2 CFR part 200 if the customer is using federal funds for the procurement. All purchase orders presented to the Vendor, but not fulfilled by the Vendor, by a TIPS Member prior to the actual termination of this agreement shall be honored at the option of the TIPS Member. The awarded Vendor may terminate the agreement with ninety (90) days prior written notice to TIPS 0000 XX Xxx Xxxxx, Xxxxxxxxx, Xxxxx 00000. The vendor will be paid for goods and services delivered prior to the termination provided that the goods and services were delivered in accordance with the terms and conditions of the terminated agreement. This termination clause does not affect the sales agreements executed by the Vendor and the TIPS Member customer pursuant to this agreement. TIPS Members may negotiate a termination for convenience clause that meets the needs of the transaction based on applicable factors, such as funding sources or other needs. TIPS Member Purchasing Procedures Usually, purchase orders or their equal are issued by participating TIPS Member to the awarded vendor and should indicate on the order that the purchase is per the applicable TIPS Agreement Number. Orders are typically emailed to TIPS at xxxxxx@xxxx-xxx.xxx. • Awarded Vendor delivers goods/services directly to the participating member. • Awarded Vendor invoices the participating TIPS Member directly. • Awarded Vendor receives payment directly from the participating member. • Fees are due to TIPS upon payment by the Member to the Vendor. Vendor agrees to pay the participation fee to TIPS for all Agreement sales upon receipt of payment including partial payment, from the Member Entity or as otherwise agreed by TIPS in writing and signed by an authorized signatory of TIPS.

  • API If the Software offers integration capabilities via an API, your use of the API may be subject to additional costs or Sage specific policies and terms and conditions (which shall prevail in relation to your use of the API). You may not access or use the API in any way that could cause damage to us or the Software, or in contravention of any applicable laws. We reserve the right in our sole discretion, to: (i) update any API from time to time; (ii) place limitations around your use of any API; and (iii) deny you access to any API in the event of misuse by you or to otherwise protect our legitimate interests.

  • ODUF Packing Specifications 6.3.1 The data will be packed using ATIS EMI records. A pack will contain a minimum of one (1) message record or a maximum of ninety-nine thousand nine hundred and ninety-nine (99,999) message records plus a pack header record and a pack trailer record. One transmission can contain a maximum of ninety-nine (99) packs and a minimum of one (1) pack.

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