Manufacturing Option definition

Manufacturing Option has the meaning set forth in Section 5.2 (Licensee Manufacturing Option).
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Manufacturing Option has the meaning set forth in Section 5.5(a).
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Manufacturing Option shall have the meaning assigned in Section 5.04.
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Examples of Manufacturing Option in a sentence

  • The Compound Manufacturing Option may be exercised by Lumena at any time during the Term upon written notice to Sanofi (the “Manufacturing Notice”).

  • Upon Lumena’s exercise of the Compound Manufacturing Option, as between the Parties, Lumena shall assume sole responsibility for performing CMC Activities with respect to Compound and for the manufacture of Compounds, subject to any Supply Agreement still in effect at such time.

  • If Licensee is Manufacturing Product pursuant to this Section 5.2 (Licensee Manufacturing Option) (which Manufacturing for purposes of this Section 5.2(d) [***]), and the Parties mutually agree that BioGenerics will purchase Product Manufactured by Licensee, BioGenerics may purchase Product Manufactured by Licensee[***] for sale in markets outside of the Territory, the Parties shall negotiate in good faith and enter into a separate definitive written Licensee manufacturing and supply agreement.

  • In case that Licensee exercises the Manufacturing Option for a Product, then Licensee shall be responsible for all packaging and labeling of each Product Manufactured by Licensee, its Affiliates or Sublicensees after completion of the technology transfer from BioGenerics to Licensee, its Affiliates or Sublicensees.

  • Thereafter, at Licensee’s sole and exclusive option, for as long as this Agreement has not been earlier terminated with respect to a particular country in the Territory and Licensee is still Manufacturing a Product in such country pursuant to Section 5.2 (Licensee Manufacturing Option), the Term shall continue to be renewed for additional Renewal Periods with respect to such country.

  • Upon Lumena’s exercise of the Compound Manufacturing Option, Lumena itself, or through a Third Party contract manufacturer, shall assume responsibility for CMC Activities with respect to Compound and for the manufacture of Compound.

  • Unless Licensee exercises the Manufacturing Option set forth in Section 5.2 (Licensee Manufacturing Option), BioGenerics, either directly or through its designee, shall be responsible for the Manufacture and supply of Products to Licensee for Commercialization in the Territory in conformance with the specifications set forth in the respective Regulatory Approval Application.

  • It is further understood that at all times prior to Lumena’s exercise of the Compound Manufacturing Option, Sanofi and its Affiliates retain the exclusive right to manufacture Compound and to perform CMC Activities with respect to Compound, for the benefit of Lumena.

  • If this Agreement has not been earlier terminated with respect to a particular country in the Territory and Licensee is Manufacturing a Product in such country pursuant to Section 5.2 (Licensee Manufacturing Option) prior to the tenth (10th) anniversary of the receipt of Regulatory Approval for such Product for such country, at Licensee’s sole and exclusive option, the Term shall be renewed for an additional three (3) years with respect to such country (the “Renewal Period”).

  • BioGenerics shall be responsible for filling Product into syringes or vials and labeling of such Product, with a label or package design provided by Licensee, until such time that Licensee has exercised the Manufacturing Option and such Manufacturing for purposes of this Section 6.3(e) has commenced and includes the manufacture of Formulated Bulk.


More Definitions of Manufacturing Option

Manufacturing Option has the meaning ascribed thereto in Section 1.54 of the License Agreement.
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Manufacturing Option shall have the meaning ascribed to it in Section 6.18.1 of this Agreement.
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Manufacturing Option shall have the meaning set forth in Section 2.6.
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Manufacturing Option has the meaning set forth in Section 11.1.
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Related to Manufacturing Option

  • Manufacturing Site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • Manufacturing Process means any process for—

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • Non-Microsoft Product means any third-party-branded software, data, service, website or product, unless incorporated by Microsoft in a Product.

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

  • Manufacturing Technology means any and all patents, patent applications, Know-How, and all intellectual property rights associated therewith, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno- associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • Manufacturing Services means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, set forth in this Agreement, required to manufacture Product or Products from Active Materials and Components;

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.

  • 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;

  • API means American Petroleum Institute.

  • Nicotine product means a product that contains nicotine and is not any of the following:

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • Tobacco product manufacturer means an entity that after the date of enactment of this act directly (and not exclusively through any affiliate) meets 1 or more of the following:

  • Finished Products means the fully assembled and shrink-wrapped Licensed Products, each including a Game Cartridge, Game Cartridge label and Printed Materials.

  • Hemp products means all products made from industrial hemp,

  • New Products means any product which is not an Enhanced Product or Existing Product but which is substantially similar to an of this Agreement, "New Product" or "New Products" shall mean any product which is not an Enhanced Product or 2 Existing Product but which is substantially similar to an Existing Product with respect to design and function and possesses reasonable performance improvements. If Company desires to purchase an Enhanced or New Product(s) from Supplier, Company shall so notify Supplier and provide Supplier the opportunity to manufacture such Enhanced or New Product(s), subject to the following conditions and procedures.

  • GSK has the meaning set forth in the preamble.

  • 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.

  • Product Manufacturer means the entity that assembles the component parts to manufacture the final Product;