Secondary Manufacturing definition

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 Manufacturing means (a) the process of producing Licensed Product for the Bayer Territory in finished form, including filling and freeze-drying of Bulk Drug Substance or (b) secondary packaging with ancillary supplies and labeling for sale to or use by an end user of Licensed Product in the Bayer Territory or (c) both.
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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.
Sample 1

Examples of Secondary Manufacturing in a sentence

  • GSK acknowledges that ALLERGAN intends to add, within the next three years, an additional production line at the Secondary Manufacturing Facility at Westport, Ireland, ("CORE 3") and an additional API Manufacturing Facility.

  • GSK shall obtain (with reasonable assistance from ALLERGAN) any necessary Marketing Authorizations from the Regulatory Authority in the Territory prior to any modifications to the API Manufacturing Facilities or Secondary Manufacturing Facilities.

  • ALLERGAN shall obtain any necessary Manufacturing Authorizations from the Regulatory Authority in the country of Manufacture prior to any modifications to the API Manufacturing Facilities or Secondary Manufacturing Facilities.

  • Patheon shall store the Components at Patheon’s storage facility at the Manufacturing Site or the Secondary Manufacturing Site and shall ensure that the Components do not become subject to any lien or other security interest.

  • Patheon shall store the Active Materials at Patheon’s storage facility at the Manufacturing Site or the Secondary Manufacturing Site and shall ensure that the Active Materials do not become subject to any lien or other security interest.

  • The Parties agree that product supply is of critical importance to the successful Commercialization in the Bayer Territory and that the transfer of Secondary Manufacturing responsibilities to Bayer is potentially beneficial.

  • Patheon shall perform its batch review and release responsibilities in accordance with the Specifications, the Quality Agreement(s) and Patheon’s standard operating procedures, which Patheon will make reasonably available to Client at the Manufacturing Site or the Secondary Manufacturing Site upon Clients request.

  • Consequently, the Parties will facilitate through the Alliance Managers or their project managers or other designees the transfer to Bayer or its Sublicensee of Secondary Manufacturing responsibility for the Initial Licensed Products for sale in the Bayer Territory.

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

  • Further, Patheon shall conduct full release testing of all Active Materials received at the Manufacturing Site or the Secondary Manufacturing Site, as applicable, not later than [***] after the date of receipt in accordance with the procedures and using the analytical testing methodologies set forth in the Specifications and the Quality Agreement(s).


More Definitions of Secondary Manufacturing

Secondary Manufacturing means the formulation, filling, finishing and packaging of Bulk Product to create Finished Product.
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Related to Secondary Manufacturing

  • 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.

  • Remanufacturing means the activity of overhauling, retrofitting, fabricating, or repairing a product or its component parts for ultimate sale at retail.

  • 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:

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

  • 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 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.

  • 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 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;

  • Manufacturing Facilities means facilities engaged in the mechanical or chemical transformation of materials or substances into new products and shall include:

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

  • Manufacturing Process means any process for—

  • Commercialization or “Commercialize” means any and all activities undertaken at any time for a particular Licensed Product and that relate to the manufacturing, marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of the Licensed Product, and interacting with Regulatory Authorities regarding the foregoing.

  • 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.

  • Hemp products means all products made from industrial hemp,

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

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

  • 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.

  • 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.

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