Secondary Manufacture definition

Secondary Manufacture or "Secondary Manufacturing" means the manufacturing and packaging process used in formulating the active drug substance and all excipients into a final dosage form of a pharmaceutical product.
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Secondary Manufacture means the preparation of lyophile vials, labeling, finishing and packaging. If SB is not selected by the parties as the primary and secondary manufacturer of PRODUCT, PDL shall have the second right to become the primary and secondary manufacturer, [CONFIDENTIAL TREATMENT REQUESTED]. (b)
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Secondary Manufacture shall have the meanings set forth in Paragraph 4.03(a) above. If SB is not selected by the PDL as the primary and secondary manufacturer of PRODUCT, PDL shall select the manufacturer of PRODUCT, which may be PDL itself. (c) Transitional Manufacturing Services. [CONFIDENTIAL TREATMENT REQUESTED] (d) SB Involvement in CMC and DMF Questions If SB Does Not Manufacture. [CONFIDENTIAL TREATMENT REQUESTED] 5. PAYMENTS AND ROYALTIES 5.01
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Examples of Secondary Manufacture in a sentence

  • The Parties shall negotiate in good faith the Cost of Goods Cap for Liquid Product for which MedImmune Vaccines performs, or has performed, Secondary Manufacture using Liquid Monovalent supplied by Wyeth.

  • The Sub-Advisor accepts the appointment and agrees to furnish the services described herein for the compensation set forth below.

  • VaxGen shall, or shall cause its Third Party fill/finish contract manufacturer, to conduct all Secondary Manufacture in accordance with the applicable Specifications, cGMP, VaxGen Quality Standards as described in a relevant Quality Protocol, as appropriate, and other relevant governmental laws, rules and regulations in the Territory.


More Definitions of Secondary Manufacture

Secondary Manufacture. OR "SECONDARY MANUFACTURING" means the blending of the monovalent Product, e.g. [***] Monovalent, to form trivalent Product, and the filling, finishing and packaging of such trivalent Product to create Finished Product.
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Secondary Manufacture or "Secondary Manufacturing"..........................4 1.36 "Specifications"..............................................................4 1.37 "Territory"...................................................................4 1.38 "[***]".......................................................................4 1.39 "U.S. Territory"..............................................................5 1.40 "Working Seeds"...............................................................5
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Related to Secondary Manufacture

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

  • Manufacture means the production of products in a factory using labour, materials, components and machinery and includes other related value-adding activities.

  • 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:

  • Third Party Manufacturer means (i) a Third Party whose primary business is contract manufacturing, or (ii) a Third Party who has a contractual arrangement with Licensee or with a sublicensee of Licensee that includes manufacturing of Client Product and/or Drug Product by such Third Party for Licensee or such sublicensee.

  • 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.

  • Original manufacturer means the original component manufacturer, the original equipment manufacturer, or the contract manufacturer.

  • Manufactured products means items and construction materials composed in whole or in part of non-ferrous metals such as aluminum; plastics and polymer-based products such as polyvinyl chloride pipe; aggregates such as concrete; glass, including optical fiber; and lumber.

  • Hemp products means all products made from industrial hemp,

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

  • Manufacturing means all activities related to the manufacture of a Compound, including planning, purchasing, manufacture, processing, compounding, storage, filling, packaging, waste disposal, labeling, leafleting, testing, quality assurance, sample retention, stability testing, release, dispatch and supply, as applicable.

  • Contract Manufacturer means a company that produces goods under contract for another company under the label or brand name of that company.

  • 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.

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

  • 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.

  • Date of manufacture means the date on which the food becomes the product as described;

  • Cannabis products means cannabis that has undergone a process whereby the plant material has been transformed into a concentrate, including, but not limited to, concentrated cannabis, or an edible or topical product containing cannabis or concentrated cannabis and other ingredients.

  • Covered Products means Your Applications, Libraries, Passes, Safari Extensions, Safari Push Notifications, and/or FPS implementations developed under this Agreement.