BDS Specifications Sample Clauses

BDS Specifications. A summary of the information that identifies, when applicable, master batch records, labeling, stencil copy, documentation and specifications pertinent to the manufacturing, testing, release, and acceptance of BDS being manufactured by AVID. This specification also establishes procedures to assure mutual consent for any specification changes.
Sample 1
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BDS Specifications. The referenced BDS must be manufactured, packaged, labeled, and handled according to the written specifications and procedures provided by HALOZYME, or as mutually agreed upon between HALOZYME and AVID. HALOZYME shall supply AVID with all in-process and final BDS release specifications, including acceptance limits for each required test and any appropriate test methods and supporting test method validation. This information will be incorporated into the AVID BDS Specification Summary. HALOZYME and AVID will mutually determine and document in writing the scope of test methodology validation required, in accordance with applicable regulatory guidelines. For those procedures which appear in the current USP/NF or other recognized standard references, a statement indicating the reference shall suffice. For those test methods developed by AVID (and that are not specific to the BDS), documentation supporting the test method shall be supplied, upon request, to HALOZYME. For test methods developed by HALOZYME, HALOZYME shall supply AVID with the supporting documentation. The rights of the parties with respect to any intellectual property developed under the Commercial Supply Agreement shall be determined in accordance with the terms and conditions set forth in the Commercial Supply Agreement. Upon review of AVID's data, HALOZYME will provide AVID with written authorization verifying AVID' ability to perform such tests. *** Confidential material redacted and submitted separately to the Commission HALOZYME WILL PROVIDE THE LABEL COPY TEXT TO AVID FOR GENERATION OF a label proof. Label proofs shall be reviewed by HALOZYME and approved by both HALOZYME and AVID prior to generation of labels. HALOZYME and AVID will mutually determine the scope of test methodology, validations required, sampling protocols, inspection methods, and specifications for each lot of BDS. A Certificate of Analysis (COA) and Certificate of Compliance (COC) shall be provided to HALOZYME by AVID. The COA and COC will be generated upon completion of all testing requirements; it will contain the items tested, corresponding acceptance criteria, test results and raw test data. AVID will issue a COA and COC and release BDS to HALOZYME. HALOZYME is responsible for the approval and release of all bulk or packaged BDS after review of AVID' COA, COC and copies executed of batch records.
Sample 1
BDS Specifications. The BDS Specifications as described in Schedule 2 to the Specifications Letter or in the Quality Agreement may be amended in writing from time to time (a) if required by the FDA or other Regulatory Authority or applicable laws, or (b) if required by Alder, provided that (i) the Alder amended BDS Specifications are reasonable in light of Sandoz’s and/or relevant Affiliate or Third Party’s technical capabilities and capacity, and that (ii) any amendment of the BDS Specifications shall require Sandoz written consent, such consent not to be unreasonably withheld. Modifications to the BDS Specifications will be managed by change control procedures as described in the Quality Agreement and must be agreed in writing by Sandoz and Alder. Alder shall be responsible for all costs and expenses related to the validation after such amendment and for any increases in cost of Manufacturing the BDS as a result of such amendment.
Sample 1

Related to BDS Specifications

  • 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%).

  • 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.

  • 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.

  • 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”).

  • 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.

  • Specification Changes (a) During the Term, GSK will accept a labeling change from Prometheus as contemplated by this Section 4.2 but otherwise the Parties acknowledge and agree that GSK does not intend to make any material changes (such as packaging design, manufacturing process or similar or related changes) to the existing Product during the Term.

  • Training Materials Training Materials will be provided for each student. Training Materials may be used only for either (i) the individual student’s reference during Boeing provided training and for review thereafter or (ii) Customer’s provision of training to individuals directly employed by the Customer.

  • Marketing Materials (a) During the term of this Agreement, the Sub-Adviser agrees to furnish the Manager at its principal office for prior review and approval by the Manager all written and/or printed materials, including but not limited to, PowerPointÒ or slide presentations, news releases, advertisements, brochures, fact sheets and other promotional, informational or marketing materials (the “Marketing Materials”) for internal use or public dissemination, that are produced or are for use or reference by the Sub-Adviser, its affiliates or other designees, broker-dealers or the public in connection with the Series, and Sub-Adviser shall not use any such materials if the Manager reasonably objects in writing within five business days (or such other period as may be mutually agreed) after receipt thereof. Marketing Materials may be furnished to the Manager by first class or overnight mail, facsimile transmission equipment, electronic delivery or hand delivery.

  • PROCEDURES SPECIFIC TO CUSTOM BASKETS The Fund has developed custom creation, redemption and other non-typical baskets (the “Custom Baskets”). Custom Baskets are intended to allow the Participant to transact in a Fund and other non-standard baskets using the Custom Basket process. The Custom Basket process allows for cash-in-lieu for certain securities as well as non-typical baskets and continues to settle through the standard CNS process at NSCC. It is the responsibility of the Participant to apply to the NSCC by contacting DTCC Participant Services at 000-000-0000 and the Transfer Agent at 000-000-0000 to allow them to receive Custom Baskets as well as the regular daily standard baskets (the “Standard Baskets”). To ensure proper tracking of a Fund to its benchmark index the following guidelines must be followed when transacting Custom Baskets:

  • API A. Reliant shall supply to Cardinal Health for Manufacturing and Packaging, at Reliant’s sole cost, the API and applicable reference standards in quantities sufficient to meet Reliant’s requirements for each Product as further set forth in Article 4. Prior to delivery of any of the API or reference standard to Cardinal Health for Manufacturing and Packaging, Reliant shall provide to Cardinal Health a copy of the API Material Safety Data Sheet (“MSDS”), as amended, and any subsequent revisions thereto. Reliant shall supply the API, reference standards, and Certificate of Analysis FOB the Facility no later than thirty (30) days before the scheduled Manufacture Date upon which such API will be used by Cardinal Health. Upon receipt of the API, Cardinal Health shall conduct identification testing of the API. Cardinal Health shall use the API solely and exclusively for Manufacturing and Packaging under this Agreement. The maximum volume of API that Reliant supplies to Cardinal Health shall not exceed the amount reflected in the Firm Commitment and the next six (6) months of the Rolling Forecast.

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