Manufacturing Program definition

Manufacturing Program means the effort to scale-up for and manufacture the Bulk Drug Substance and Drug Product for clinical and commercial supply.
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Manufacturing Program. The manufacturing program as defined in Section 7.3 of this Agreement.
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Manufacturing Program means the effort to scale-up for and
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Examples of Manufacturing Program in a sentence

  • For clarity, Biogen shall have the right, in its sole discretion, to determine whether to seek patent protection for any Biogen Results that are not jointly owned with Ionis, and Biogen shall control and be responsible for all aspects of the Prosecution and Maintenance of any Patent Right within such Biogen Results (each, a “Biogen Manufacturing Program Patent”) in accordance with Section 7.2.2(c) of this Agreement.

  • The Project Team shall coordinate the efforts of the parties with respect to the Manufacturing Program.

  • Lilly and Ophidian will disclose and make available to each other promptly the results of the work conducted in the Clinical Development Program, Process Development Program and Manufacturing Program, including without limitation all preclinical, clinical, regulatory, and other information known by Lilly or Ophidian concerning the Drug Product at any time during the term of this Agreement.

  • MacroGenics shall thereafter during the Agreement Term, continue to promptly and regularly disclose any material new MacroGenics Know-How related to Manufacturing Program DARTs and Licensed Products to Servier or to the Third Party manufacturer mentioned above at Servier’s cost.

  • Such license will be [***] with respect to any [***] as follows: on a country-by-country, product-by-product and Biogen Manufacturing Program Patent-by-Biogen Manufacturing Program Patent basis, Ionis will pay to Biogen [***].

  • The Project Team shall provide the day-to-day management for the collaboration and shall be responsible for directing and overseeing specific activities hereunder, including but not limited to the Clinical Development Program, the Process Development Program and the Manufacturing Program.

  • The Project Team shall prepare and oversee the implementation of a detailed, overall manufacturing plan, which shall address fully the key elements necessary for the clinical and commercial manufacture of the Bulk Drug Substance and the Drug Product and the roles of each party in the Manufacturing Program (the "MANUFACTURING PLAN").

  • The Manufacturing Program shall commence as soon as practicable after the Effective Date.

  • Hollister-Stier shall ensure that all Chemicals and Materials suppli▇▇ ▇▇ ▇▇▇▇▇▇▇▇▇-Stier on behalf of the Manufacturing Program (as may be se▇ ▇▇▇▇▇ ▇▇ ▇▇▇▇bit 1 of this Agreement) are suitable for use under this Manufacturing Agreement, comply with All Applicable Laws and Regulations (including without limitation those relating to the import of such materials) and receive all required governmental and regulatory approvals, including without limitation customs and FDA approvals.

  • If one or more Biogen Manufacturing Program Patents expires, is invalidated or otherwise ceases to Cover a product bearing royalties as set forth above, the applicable royalty rate under this Section 4.4.2 shall be recalculated to reflect the number of Biogen Manufacturing Program Patents then-Covering such product.


More Definitions of Manufacturing Program

Manufacturing Program means a program developed by a Project Team and approved of by the Managers for the Manufacturing of a product and will include a budget, tasks an timelines.
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Related to Manufacturing Program

  • Manufacturing Process means any process for—

  • Marketing program means a program established by order of the director pursuant to this act prescribing rules and regulations governing the marketing for processing, distributing, selling, or handling an agricultural commodity produced in this state or agricultural commodity input during a specified period and

  • Manufacturing Facility means buildings and structures, including machinery and equipment, the primary purpose of which is or will be the manufacture of tangible goods or materials or the processing of such goods or materials by physical or chemical change.

  • 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 means all activities directed to sourcing of necessary raw materials, producing, processing, packaging, labeling, quality assurance testing, release of a Licensed Product or Licensed Product candidate, whether for Development or Commercialization. When used as a verb, “Manufacture” means to engage in Manufacturing.