Validation Materials definition

Validation Materials means those documents, samples and standards, including equipment qualification, validation methods, protocols and reports, master batch records, stability study reports, compatibility studies, specifications, samples used during validation, stability samples and reference standards, not included in the other Purchased Assets or in the Arena Licensed Know-How or Arena Licensed Records, that are used to provide documented evidence that the manufacturing process for the Products and analytical methods used to release starting materials, intermediates and final Products are validated.
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Validation Materials has the meaning ascribed to the term “Validation Materials” in the Supply Agreement.
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Examples of Validation Materials in a sentence

  • Checklist for Submitting Validation MaterialsOrganize and Sort Validation Materials CHECK THAT ALL SIGNATURES ARE OBTAINED.

  • They may use a dictionary and will have 90 minutes to work on their translation.

  • Nazir A., Jeng J.Y.*, (2020) Buckling Behavior of Additively Manufactured Cellular Columns: Experimental and Simulation Validation, Materials and Design, Vol.

  • Terms and Conditions This is a legal agreement between you (Client or you) and [IHA Ltd, of Chancery House, St Nicholas Way, Sutton, SM1 1JB] (Validator or we) for your purchase of validation services and validation materials ("Validation Services" and "Validation Materials" respectively).

  • Complete To Be Business Capabilities prepare & submit Business Capabilities Validation Materials for HSD review & approval, 8.

  • Early in the 1900s, Ferdinand de Saussure offered the idea of human language as a static system of reliable units, precise through the disagreements between them (Nerlich, 2010).By presenting a difference between synchronic analysis and diachronic analysis of human language, Saussure developed the grounds for the study of modern discipline in linguistics.

  • The Consultant shall develop for the WUSM Project Manager’s review and approval: Program Validation Materials, Schematic Design Documents, Design Development Documents, and Construction Documents, to establish the scope, relationship forms, size, and appearance of the project in accordance with the requirements of all Agreements and Design Standards.

Related to Validation Materials

  • Construction materials means any tangible personal property that will be

  • Information Materials has the meaning given that term in Section 9.6.

  • Study Materials means all the materials and information created for the Study, or required to be submitted to the Sponsor including all data, results, Biological Samples, Case Report Forms (or their equivalent) in whatever form held, conclusions, discoveries, inventions, know-how and the like, whether patentable or not, relating to the Study, which are discovered or developed as a result of the Study, but excluding the Institution’s ordinary patient records.

  • Third Party Materials means materials and information, in any form or medium, including any software, documents, data, content, specifications, products, equipment or components of or relating to the Services that are not proprietary to NCIT.

  • Program Materials means the documents and information provided by the Program Administrator specifying the qualifying EEMs, technology requirements, costs and other Program requirements, which include, without limitation, program guidelines and requirements, application forms and approval letters.

  • Supplier Materials has the meaning set out in clause 8.1(g);

  • IP Materials has the meaning given to it in clause E8.1 (Intellectual Property Rights).

  • Contractor Materials means Materials owned or developed prior to the provision of the Work, or developed by Contractor independently from the provision of the Work and without use of the Court Materials or Confidential Information.

  • Customer Materials any materials, data, information, software, equipment or other resources owned by or licensed to You and made available to Us pursuant to facilitating Your use of the Services, including Customer Data.

  • Biological Materials means certain tangible biological materials that are necessary for the effective exercise of the Patent Rights, which materials are described on Exhibit A, as well as tangible materials that are routinely produced through use of the original materials, including, for example, any progeny derived from a cell line, monoclonal antibodies produced by hybridoma cells, DNA or RNA replicated from isolated DNA or RNA, recombinant proteins produced through use of isolated DNA or RNA, and substances routinely purified from a source material included in the original materials (such as recombinant proteins isolated from a cell extract or supernatant by non-proprietary affinity purification methods). These Biological Materials shall be listed on Exhibit A, which will be periodically amended to include any additional Biological Materials that Medical School may furnish to Company.

  • Training Materials means any and all materials, documentation, notebooks, forms, diagrams, manuals and other written materials and tangible objects, describing how to maintain the Facilities, including any corrections, improvements and enhancements thereto to the Bloom Systems which are delivered by Operator to Owner, but excluding any data and reports delivered to Owner.

  • Evaluation Material shall have the meaning ascribed thereto in Section 6.3(a).

  • Construction material means an article, material, or supply brought to the construction site by the Contractor or a subcontractor for incorporation into the building or work. The term also includes an item brought to the site preassembled from articles, materials, or supplies. However, emergency life safety systems, such as emergency lighting, fire alarm, and audio evacuation systems, that are discrete systems incorporated into a public building or work and that are produced as complete systems, are evaluated as a single and distinct construction material regardless of when or how the individual parts or components of those systems are delivered to the construction site. Materials purchased directly by the Government are supplies, not construction material.

  • SAP Materials means any software, programs, tools, systems, data, or other materials made available by SAP or any other member of the SAP Group to Partner or to an End User (either directly or indirectly via Partner) prior to or in the course of the performance under any part of this Agreement including, but not limited to, the other SAP Products.

  • Third Party Material means software, software development tools, methodologies, ideas, methods, processes, concepts and techniques owned by, or licensed to a third party and used by the Service Provider in the performance of the Services;

  • Licensed Materials means any materials that Executive utilizes for the benefit of the Company (or any Subsidiary thereof), or delivers to the Company or the Company’s Customers, which (a) do not constitute Work Product, (b) are created by Executive or of which Executive is otherwise in lawful possession and (c) Executive may lawfully utilize for the benefit of, or distribute to, the Company or the Company’s Customers.

  • Developed Materials means Materials created, made, or developed by Contractor or Subcontractors, either solely or jointly with the Judicial Branch Entities or JBE Contractors, in the course of providing the Work under this Agreement, and all Intellectual Property Rights therein and thereto, including, without limitation, (i) all work-in-process, data or information, (ii) all modifications, enhancements and derivative works made to Contractor Materials, and (iii) all Deliverables; provided, however, that Developed Materials do not include Contractor Materials.

  • Manufacturing Materials means parts, tools, dies, jigs, fixtures, plans, drawings, and information produced or acquired, or rights acquired, specifically to fulfill obligations set forth herein.

  • Instructional materials means relevant instructional

  • Regulatory Materials means, with respect to a Licensed Product for any particular indication in any particular jurisdiction, regulatory applications and submissions (and any supplements or amendments thereto), and any notifications, communications, correspondence, registrations, drug master files, Regulatory Approvals and/or other filings made to, received from or otherwise conducted with a Regulatory Authority, including BLAs and INDs, as applicable, that relate to such Licensed Product in such jurisdiction. Regulatory Materials also include presentations, responses, and applications for Regulatory Approvals.

  • Proprietary Materials means any tangible chemical, biological or physical research materials that are furnished by or on behalf of one Party to the other Party in connection with this Agreement, regardless of whether such materials are specifically designated as proprietary by the transferring Party.

  • GOODS / MATERIALS means any of the articles, materials, machinery, equipments, supplies, drawing, data and other property and all services including but not limited to design, delivery, installation, inspection, testing and commissioning specified or required to complete the order.

  • Solicitation Materials means, collectively, the solicitation materials with respect to the Plan.

  • Cloud Materials means any materials provided or developed by SAP (independently or with Provider’s cooperation) in the course of performance under the Agreement, including in the delivery of any support or Consulting Services to Provider or its Customers. Cloud Materials do not include any Customer Data, Provider Confidential Information, or the SAP Cloud Service.

  • Manufacturing Process means any process for—

  • Standard Materials means all Materials not specified as Custom Materials.