MANUFACTURING INSTRUCTIONS Sample Clauses

MANUFACTURING INSTRUCTIONS. The supplier shall always, concerning manufacturing instructions, observe the technical instructions from Autoliv.
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MANUFACTURING INSTRUCTIONS. Manufacturing instructions are prepared as master documents for the manufacture of all materials by the Production Department at Corixa. Manufacturing instructions are maintained under a change control system in which all changes to procedures are evaluated, justified and approved prior to implementation. Validation may be required prior to approval for significant changes that may produce differences in the quality, purity, safety, and/or potency of a product. Copies of these master documents are prepared by a representative of Quality Assurance upon formal request by Production to initiate the preparation of reagents, containers, closures, components, or finished products. Each manufacturing instruction provides information concerning the requirements for raw materials, the necessary equipment, and the procedure. In addition, the manufacturing instructions require the operator to provide information concerning the identification of equipment and materials used, the persons performing the operations, the date that the operations were performed, the yields obtained from the operation, and any further information required to provide complete traceability of the manufacture of that material. Manufacturing instructions are divided into four categories based upon the type of material being prepared, as summarized below: Equipment Preparation Records (EPRs) provide instructions for the cleaning and preparation of equipment in the Production area; Reagent Preparation Records (RPRs) provide instructions for the preparation of various reagents such as media, buffers, and organic solvents that are used in the Production area during the manufacture of intermediates and/or finished products; Container/Closure Preparation Records (CPRs) provide instructions for the preparation of containers and closures that are used as either final product containers or containers for in-process materials; Master Batch Records (MBRs) provide instructions for the manufacture of intermediates and/or finished products. An individual MBR may yield an in-process material, or may yield the final product. Each manufacturing instruction in place at Corixa corresponds to a part number that identifies the resulting product. A part number specification sheet is prepared for each part number assigned that contains all information regarding the material manufactured (see above). As copies of manufacturing instructions are issued by Quality Assurance to Production personnel for the initiation of a...
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MANUFACTURING INSTRUCTIONS. NOVARTIS agrees that manufacture of the LdT Finished Products is carried out according to the manufacturing instructions. NOVARTIS or its associate will submit the Master Batch Record to IDENIX for approval before the first start of production or before an approved change is implemented, if requested by IDENIX. Supporting documentation will be provided stating all changes made to the master batch record. Further documentation, e.g. excerpts of manufacturing records, will be submitted for perusal by IDENIX upon reasonable request. Shipment shall be made as promptly as possible.
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MANUFACTURING INSTRUCTIONS. Licensor shall compile and prepare the Manufacturing Instructions for use by Licensee in furtherance of the provisions of Section 2.2. Subject to the terms set forth in Section 2.2 above and payment of royalties pursuant to Article V of this Agreement, Licensor hereby grants Licensee an exclusive fully paid license to use, copy, and revise the Manufacturing Instructions in connection with the manufacture of UV Treatment Systems, under the same conditions as Licensee's right to manufacture the UV Treatment Systems for installation within the Territory. Licensee's right to use the Manufacturing Instructions under this license also shall be in accordance with the terms of the Trust Agreement attached hereto as Exhibit A.
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MANUFACTURING INSTRUCTIONS. Xxxxx will supply to Aviron a master copy of the relevant Manufacturing Records for Aviron to authorize and approve in writing as being consistent with the Specifications and the Agency Approval for the Product prior to the said documents being used. Significant changes to such documents similarly will be agreed prior to implementation.
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MANUFACTURING INSTRUCTIONS. Alexza and Autoliv are jointly responsible for ensuring the appropriate process controls are implemented. Autoliv is responsible for creation and approval of the manufacturing control plan(s) according to Autoliv’s change control process. Alexza will approve the Autoliv manufacturing control plan(s) as well as references within the CPD Heat Package control plan(s)
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MANUFACTURING INSTRUCTIONS. Except as set forth in this Section 6.4, all right, title and interest to the Manufacturing Instructions shall be *** . Plexus hereby grants to GenMark a *** license to use the *** as necessary or helpful to manufacture or have manufactured the Products or any other products of GenMark or its Affiliates. In addition, the parties acknowledge and agree that Plexus will ensure that the Manufacturing Instructions are set forth in writing and will promptly, and in any event with *** , provide a complete set of the same to GenMark from time to time upon GenMark’s request. All rights and licenses granted to GenMark under or pursuant to this Section 6.4 are, and shall otherwise be deemed to be, for purposes of Paragraph 365(n) of the U.S. Bankruptcy Code, licenses of rights to “intellectual property” as defined under Paragraph 101(35A) of the U.S. Bankruptcy Code. The parties agree that GenMark, as licensee of such rights under this Agreement, shall retain and may fully exercise all of its rights and elections under the U.S. Bankruptcy Code.
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MANUFACTURING INSTRUCTIONS. 3.1 Manufacturer shall perform the manufacture of the Product strictly in conformity with the instructions as specified in the GMP Agreement.
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Related to MANUFACTURING INSTRUCTIONS

  • Manufacturing and Marketing Rights The Company has not granted rights to manufacture, produce, assemble, license, market, or sell its products to any other person and is not bound by any agreement that affects the Company's exclusive right to develop, manufacture, assemble, distribute, market, or sell its products.

  • 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 [***].

  • Manufacturing Rights Manufacturing Rights will be governed by Attachment 6.

  • Manufacturing and Supply Genentech shall be responsible for manufacturing and supplying Licensed Products for clinical use and commercial sale in the Genentech Field.

  • 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.

  • Manufacturing Agreement Each of the Sellers (as applicable) shall have executed and delivered to the Buyer the Manufacturing Agreement with respect to the portion of the Business conducted at the applicable Facility.

  • 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 Technology Transfer With respect to each Technology Transfer Product, upon AbbVie’s written request after the Inclusion Date for the Included Target to which such Technology Transfer Product is Directed, Morphic shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party manufacturer) of all Morphic Know-How and Joint Know-How relating to the then-current process for the Manufacture of such Technology Transfer Product (the “Manufacturing Process”) and to implement the Manufacturing Process at facilities designated by AbbVie (such transfer and implementation, as more fully described in this Section 5.3, the “Manufacturing Technology Transfer”). To assist with the Manufacturing Technology Transfer, Morphic will make its personnel reasonably available to AbbVie during normal business hours for up to [***] FTE hours with respect to each Included Target (in each case, free of charge to AbbVie) to transfer and implement the Manufacturing Process under this Section 5.3. Thereafter, if requested by AbbVie, Morphic shall continue to perform such obligations; provided, that AbbVie will reimburse Morphic for its full-time equivalent (FTE) costs (for clarity, in excess of [***] FTE hours) and any reasonable and verifiable out-of-pocket costs incurred in providing such assistance. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

  • Commercialization Reports After the First Commercial Sale of a Licensed Product anywhere in the Territory, LICENSEE shall submit to Cornell semi-annual reports on or before each February 28 and August 31 of each year. Each report shall cover LICENSEE’s (and each Affiliate’s and Sublicensee’s) most recently completed calendar half-year and shall show:

  • Quality Agreement Each Party will comply with the terms of the Quality Agreement in the performance of its obligations hereunder including record retention, audits and inspections, change control, adverse events and product recall. The Parties will conduct periodic Product quality reviews in accordance with the terms of the Quality Agreement.

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