Master Batch Documentation definition

Master Batch Documentation as to a Product, means the documents that specify or reference the complete set of formal instructions for the Manufacture of such Product, including Material descriptions, in process testing and finished Product Specifications developed and mutually approved by Hovione and Client under the terms of this Agreement, as amended from time to time by in accordance with Section 8.3.
Sample 1Sample 2
Master Batch Documentation. , as to a Product, means the documents that specify or reference the complete set of formal instructions for the Manufacture of such Product, including Material descriptions, in process testing and finished Product Specifications developed and mutually approved by Hovione and Client under the terms of this Agreement, as amended from time to time by in accordance with Section 8.3.
Sample 1

Examples of Master Batch Documentation in a sentence

  • Hovione may not subcontract the performance of any of its obligations under this Agreement that are specific to the Manufacture of Product or are part of the Manufacturing Process as set forth in the Master Batch Documentation unless expressly permitted under the applicable Work Plan or otherwise with the prior written consent of Client, and then only to qualified Third Parties.

  • Hovione will, at Client’s request upon the occurrence of (b)(i), (b)(ii) or (b)(iii) below and subject to the applicable terms set forth in such subsections, cooperate with Client in the transfer of the Manufacturing Process and Master Batch Documentation to one (1) Third Party designated by Client by providing such technical assistance and documentation as Client may reasonably request (a “Technology Transfer”).

  • As part of Development Services, Hovione shall deliver to Client the Master Batch Documentation, the Product Specifications, Product-specific procedures, protocols and technical reports, and such other documents as are specified in the applicable Work Plan, including but not limited to, raw data and IPC results (the “Manufacturing Documents”).

  • Prior to Process Validation Completion for the Product and subject to the limits set forth in Section 14.4, Hovione will, within * days of the end of each calendar year, issue Client a credit in the amount of the quantity of Materials represented by such Material Loss, but solely to the extent such Material Loss results from Hovione’s gross negligence or willful misconduct or failure to perform Manufacturing activities in accordance with the Master Batch Documentation and cGMP.

  • Growth Hubs are encouraged to take a scientific approach tointeracting with customers and to develop evidence of “what works”.

  • In addition, Hovione will test and release Product in accordance with the Product Specifications and the Master Batch Documentation.

Related to Master Batch Documentation

  • Master Batch Record means the document, proposed by Lonza and approved by Customer, which defines the manufacturing methods, test methods and other procedures, directions and controls associated with the manufacture and testing of Product.

  • Batch Record means the production record pertaining to a Batch.

  • Design Documentation means all schematics and test, assembly and package documentation relating to the Product, including all design, specification and assembly documentation and data files for Materials, which is necessary for the production, manufacture, qualification, testing and delivery of the Product to be attached as Exhibit A.

  • Limited Documentation Program The guidelines under which the Seller generally originates Mortgage Loans principally on the basis of the Loan-to-Value Ratio of the related Mortgage Loan and the creditworthiness of the Mortgagor.

  • Product Documentation means the specific materials listed under “Documentation” at xxx.xxxxxx.xxx/xxxxx, as updated by Vocera from time to time.

  • User Documentation means explanatory and informational materials concerning the Company products, in printed or electronic format, which the Company or any Subsidiary has released for distribution to end users with such Company products, which may include manuals, descriptions, user and/or installation instructions, diagrams, printouts, listings, flow-charts and training materials, contained on visual media such as paper or photographic film, or on other physical storage media in machine readable form.

  • Technical Documentation means designs, reports, photographs, drawings, plans, specifications, computer software, surveys, calculations and other data, information and material collected, computed, drawn or produced, including computer print-outs.

  • Related Documentation means, with respect to Software, all materials, documentation (including control documentation utilized in connection with an audit), specifications, technical manuals, user manuals, flow diagrams, file descriptions and other written information that describes the function and use of such Software, but excluding source code.

  • Program Documentation refers to the user manuals, help windows, readme files for the Services and any Oracle Software. You may access the documentation online at xxxx://xxxxxx.xxx/contracts or such other address specified by Oracle.

  • Service documentation means all records and information on one or more documents, including documents that may be created or maintained in electronic software programs, created and maintained contemporaneously with the delivery of services, and kept in a manner as to fully disclose the nature and extent of services delivered that shall include the items delineated in paragraph (E) of this rule to validate payment for medicaid services.

  • ISM Code Documentation means, in relation to a Vessel, the document of compliance (DOC) and safety management certificate (SMC) issued by a Classification Society pursuant to the ISM Code in relation to that Vessel within the periods specified by the ISM Code;

  • Supporting Documentation means the documents listed in Schedule A of this Certificate which forms part of this

  • Account Documentation means any and all Account information, credit applications, Cardholder Agreements and change in terms notices, Charge Transaction Data, charge slips, credit slips, payments, credit information and documents or forms of any type and in any media relating to the Program, excluding materials used for advertising or solicitations.

  • Flood Documentation means, with respect to each Mortgaged Property located in the United States of America or any territory thereof, (i) a completed “life-of-loan” Federal Emergency Management Agency standard flood hazard determination (to the extent a Mortgaged Property is located in a Special Flood Hazard Area, together with a notice about Special Flood Hazard Area status and flood disaster assistance duly executed by the Borrower and the applicable Loan Party relating thereto) and (ii) a copy of, or a certificate as to coverage under, and a declaration page relating to, the insurance policies required by Section 5.02(c) hereof and the applicable provisions of the Security Documents, each of which shall (A) be endorsed or otherwise amended to include a “standard” or “New York” lender’s loss payable or mortgagee endorsement (as applicable), (B) name the Collateral Agent, on behalf of the Secured Parties, as additional insured and loss payee/mortgagee, (C) identify the address of each property located in a Special Flood Hazard Area, the applicable flood zone designation and the flood insurance coverage and deductible relating thereto and (D) be otherwise in form and substance reasonably satisfactory to the Collateral Agent.

  • Programme Document means each of the Master Trust Deed, the Agency Agreement, the Registrar Agreement, the Margin Account Agreement, the Margin Account Security Agreement, the Portfolio Administration Agreement, the Operating Procedures Agreement, the Determination Agency Agreement, the Broker Dealer of Record Agreement, the Services Agreement and each Authorised Participant Agreement and "Programme Documents" means all such documents.

  • Quality Agreement has the meaning set forth in Section 9.6.

  • Software Documentation means software information, being technical information used, or useful in, or relating to the design, development, use or maintenance of any version of a software programme.

  • Design Development Documents means the Drawings, Specifications and other documents prepared by the Trade Contractor that establish and describe the size and character of the Trade Contractor Work as to architectural, civil, structural, mechanical and electrical systems, graphics and signage, and other elements, and which include typical construction details, equipment layouts and specifications that identify major materials and systems.

  • Implementation Agreement means the Implementation Agreement dated ……… by and between the GOB, PGCB and the Company in connection with the Project, and also includes any amendment of it made from time to time;

  • Project Implementation Plan means the detail plan submitted by the Developer with regard to development of Project Facilities and its operation and management thereof in accordance with this Agreement and to be appended as Schedule 9 to this Agreement.

  • Project Implementation means all steps which the Grantee undertakes in order to deliver the Project which is being supported by funding provided under this Grant Contract. Any reference to UK primary legislation (Acts) or secondary legislation (Statutory Instruments) in this Grant Contract includes reference to any changes to or replacement of those Acts or Statutory Instruments.