Raw and starting materials Sample Clauses

Raw and starting materials. If raw materials and process aids are procured by Unigene, and such material becomes part of the API or comes into contact with the API (or with its precursors) during its manufacture, Unigene ensures and certifies that their quality is in compliance with the current TSE Guideline (Note for Guidance on minimising the risk of transmitting spongiform encephalopathy agents via human and veterinary medicinal products (EMEA/410/01, Rev. 2 or applicable update). This also applies to raw materials and process aids used before the synthesis of the Active Pharmaceutical Ingredient Starting Material (API-SM). The Novartis TSE Questionnaire templates (see Enclosure D) are provided to outline the requirements and are the basis for an assessment of TSE safety. Unigene is expected to ensure that it is completed: • either for each batch of each material used throughout the entire synthesis or that comes into contact with the API (e.g. cleaning material, primary packaging material) • or – in case that only product-specific TSE statements are available for such a material—that a valid change control statement (see Enclosure D, questionnaire on page 1) is included in such statement. Novartis reserves the right to audit (for Quality purposes) or request copies (for Regulatory purposes) of any or all questionnaires of material used during the synthesis or primary packaging of the API. Novartis acknowledges and consents to limiting access of this information on a “need-to-know” basis only. Furthermore, a TSE compliance statement (see template, Enclosure E) shall be provided to Novartis for each batch of the API, signed by the Quality Assurance Unit of Unigene. For authorities asking for more information (e.g., Japan), Unigene shall readily provide the documentation needed or promptly request information from its vendors. Upon receipt of starting materials for Manufacturing, the shipping containers must be checked by Unigene for: Completeness and accuracy of material shipment External condition Intact and authentic seal Identity of material Unigene must maintain records of each batch of starting material used in Manufacturing consisting of quantity delivered, usage of each batch, and investigation into any discrepancy. If Novartis orders starting materials for use in Manufacturing, Unigene is responsible for testing and release of material according to agreed upon test methods and specifications, as specified by Novartis. If not specified, Unigene will be responsible for test m...
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Raw and starting materials 

Related to Raw and starting materials

  • 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.

  • 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.

  • 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.

  • Advertising Materials; Filed Documents (a) Advertising and sales literature with respect to any Fund prepared by the Company or its agents for use in marketing its Contracts will be submitted to that Fund or its designee for review before such material is submitted to any regulatory body for review. No such material shall be used if the Fund or its designee reasonably objects to such use in writing, transmitted by facsimile within two business days after receipt of such material.

  • Computational Materials and Structural Term Sheets (a) Not later than 10:30 a.m., New York time, on the business day before the date on which the Current Report relating to the Offered Certificates of a Series is required to be filed by the Company with the Commission pursuant to Section 5(b) hereof, the Underwriter shall deliver to the Company five complete copies of all materials provided by the Underwriter to prospective investors in such Offered Certificates that constitute (i) "Computational Materials" within the meaning of the no-action letter dated May 20, 1994 issued by the Division of Corporation Finance of the Commission to Xxxxxx, Xxxxxxx Acceptance Corporation I, Xxxxxx, Peabody & Co. Incorporated, and Xxxxxx Structured Asset Corporation and the no-action letter dated May 27, 1994 issued by the Division of Corporation Finance of the Commission to the Public Securities Association (together, the "Xxxxxx Letters"), the filing of which material is a condition of the relief granted in such letter (such materials being the "Computational Materials"), and (ii) "Structural Term Sheets" within the meaning of the no-action letter dated February 17, 1995 issued by the Division of Corporation Finance of the Commission to the Public Securities Association (the "PSA Letter"), the filing of which material is a condition of the relief granted in such letter (such materials being the "Structural Term Sheets"). Each delivery of Computational Materials and Structural Term Sheets to the Company pursuant to this paragraph (a) shall be effected by delivering four copies of such materials to counsel for the Company on behalf of the Company at the address specified in Section 3 hereof and one copy of such materials to the Company.

  • MARKETING MATERIALS AND REPRESENTATIONS (a) The Participant represents and warrants that it will not make any representations concerning a Fund, Creation Units or Shares, other than those consistent with the Prospectus or any Marketing Materials (as defined below) furnished to the Participant by the Distributor.

  • Pre-Existing Materials Subject to Section 3.A, Consultant will provide the Company with prior written notice if, in the course of performing the Services, Consultant incorporates into any Invention or utilizes in the performance of the Services any invention, discovery, idea, original works of authorship, development, improvements, trade secret, concept, or other proprietary information or intellectual property right owned by Consultant or in which Consultant has an interest, prior to, or separate from, performing the Services under this Agreement (“Prior Inventions”), and the Company is hereby granted a nonexclusive, royalty-free, perpetual, irrevocable, transferable, worldwide license (with the right to grant and authorize sublicenses) to make, have made, use, import, offer for sale, sell, reproduce, distribute, modify, adapt, prepare derivative works of, display, perform, and otherwise exploit such Prior Inventions, without restriction, including, without limitation, as part of or in connection with such Invention, and to practice any method related thereto. Consultant will not incorporate any invention, discovery, idea, original works of authorship, development, improvements, trade secret, concept, or other proprietary information or intellectual property right owned by any third party into any Invention without Company’s prior written permission.

  • Manufacturer’s Warranties If a Lease Vehicle is covered by a Manufacturer’s warranty, the Lessee, during the Vehicle Term for such Lease Vehicle, shall have the right to make any claims under such warranty that the Lessor could make.

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