Manufacturing Protocol definition

Manufacturing Protocol means specified manufacturing protocols, partly summarized in Exhibit A of Appendix, necessary to produce Product, including the manufacturing, production, processing, formulation, fill, finish, packaging, labeling, handling, QC testing, stability testing, the Release and Delivery, storage of Product, described more particularly in the applicable SOW.
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Examples of Manufacturing Protocol in a sentence

  • Services, Manufacturing Protocol, deliverables, timelines, milestones, quantity, budget, payment schedule and such other details and special arrangements as are agreed to by the Parties with respect to the activities to be performed under such SOW.

  • Each LOT shall be sampled and tested against the Specifications, and the quality assurance department of SR shall review the documentation relating to the Manufacture of the LOT and assess if the Manufacture has taken place in compliance with GMP (if applicable) and the Manufacturing Protocol.

  • If, based upon the tests and documentation review performed under Section 6.1, a LOT conforms to the Specifications and was Manufactured according to GMP (if applicable) and the Manufacturing Protocol, then a Certificate of Compliance shall be completed and approved by the quality assurance department of SR.

  • SR shall provide CorneaGen with a copy of that portion of any written response submitted to the applicable Authority that directly addresses the Manufacture of Product or the Manufacturing Protocol.

  • Notwithstanding the above, CorneaGen acknowledges that SR will use SR’s new-CPC facility with Manufacturing Protocol 2 or 3 or other variant of improved manufacturing protocol, when the SR’s new-CPC facility will be ready for use, as indicated in Appendix and Exhibit C of Appendix.

  • If there is non-conformity to Specification but such non-conformity is not a SR Non-Conforming LOT, the Parties shall negotiate in good faith an amount of payment by CorneaGen for such LOT, taking into consideration the nature of the Product and/or Primary Raw Material, the completeness of the Manufacturing Protocol (including the success rate of the Product), the time and costs and expenses incurred by SR associated with producing such LOT and any other element reasonably necessary to be considered.

Related to Manufacturing Protocol

  • Manufacturing Process means any process for—

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • Manufacturing Know-How means all information, techniques, inventions, discoveries, improvements, practices, methods, knowledge, skill, experience and other technology, whether or not patentable or copyrightable, and any copyrights based thereon, relating to or necessary or useful for the production, purification, packaging, storage and transportation of Collaboration Products, including without limitation specifications, acceptance criteria, manufacturing batch records, standard operating procedures, engineering plans, installation, operation and process qualification protocols for equipment, validation records, master files submitted to the FDA, process validation reports, environmental monitoring processes, test data including pharmacological, toxicological and clinical test data, cost data and employee training 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.

  • Product Specifications means the specifications, features and/or terms of any "Contract" (as defined in the LME Rules) listed for trading on the LME, as described in the LME Rules;