Manufacturing Strain definition

Manufacturing Strain means the production strain that expresses the Drug Substance, which was developed by Pfenex using the Pfenex Expression Technology prior to the Effective Date as described in more detail in that certain memorandum exchanged between the Parties on the Signature Date and referencing this Agreement (or such other production strain that expresses the Drug Substance that Pfenex may develop to replace or supplement the existing production strain; provided that such replacement or supplement must first be approved by Hospira).
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Manufacturing Strain means, with respect to a Collaboration Product, a strain of Pseudomonas fluorescens incorporating a nucleic acid sequence that is optimized to express the protein that is the active ingredient of such Collaboration Product.
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Manufacturing Strain means, with respect to a Named sparX Protein, a production strain developed by Pfenex in which an Optimized Nucleic Acid Sequence is incorporated into the Pfenex System to Express such Named sparX Protein pursuant to the applicable Development Plan.
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Examples of Manufacturing Strain in a sentence

  • For clarity, the Commercialization License does not include the right for Hospira to modify the Manufacturing Strain or authorize any Third Party to do so without the prior written consent of Pfenex.

  • To Pfenex’s Knowledge, the Manufacturing Strain (and the constituent components thereof) used by or on behalf of Pfenex as of the Signature Date does not infringe the Intellectual Property rights of any Third Party.

  • Pfenex hereby grants Arcellx an exclusive option with respect to each Named sparX Protein to obtain an exclusive license to use the applicable Manufacturing Strain to manufacture or have manufactured such Named sparX Protein and to develop and commercialize Protein Products incorporating such Named sparX Protein, as further described in Section 5.2 (each, a “Commercial Option”).

  • The Commercial License granted under Section 5.2.1, with respect to a particular Manufacturing Strain and corresponding Licensed sparX Protein and Protein Products, includes the right to grant sublicenses through multiple tiers; provided, however, that Arcellx may not grant or authorize sublicenses through multiple tiers under such Commercial License without the prior written consent of Pfenex, which shall not be unreasonably withheld, conditioned or delayed; [***].

  • Arcellx may alter or modify the Transferred Technology comprising methods and materials (other than the Manufacturing Strain or constituents thereof) for the expression, extraction, purification and testing of the corresponding Named sparX Protein (“Permitted Modifications”).

  • The streamlined requirements for spare engines do not require that “…individual engines are [be] tracked on individual aircraft by operations.” The draft proposal does not contemplate a new system by which spare engines would be traceable.

  • Accordingly, if Arcellx exercises a Commercial Option with respect to a Named sparX Protein and corresponding Manufacturing Strain hereunder, the Term shall continue on a Protein Product-by-Protein Product basis until expiration of the Royalty Term for each such Protein Product.

  • Arcellx acknowledges that the use or modification of a Manufacturing Strain other than as permitted under this Agreement could cause irreparable damage to Pfenex.

Related to Manufacturing Strain

  • 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—

  • 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.

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

  • Manufacturing operation means a process in which materials are changed, converted, or transformed into a different state or form from which they previously existed and includes refining materials, assembling parts, and preparing raw materials and parts by mixing, measuring, blending, or otherwise committing such materials or parts to the manufacturing process. "Manufacturing operation" does not include packaging.

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

  • 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 Technology means any and all patents, patent applications, know-how, and all intellectual property rights associated therewith that are owned or controlled by Licensor, 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 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.

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

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

  • Bulk Product means Licensed Product supplied in a form other than Finished Product which can be converted into Finished Product.

  • Final Product means a reasonably homogenous cannabis product in its final packaged form created using the same standard operating procedures and the same formulation.

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

  • Aerosol Product means a pressurized spray system that dispenses product ingredients by means of a propellant contained in a product or a product's container, or by means of a mechanically induced force. “Aerosol Product” does not include “Pump Spray.”

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

  • Finished Products means any one or more of the following petroleum oils, or a mixture or combination of these oils, to be used without further processing except blending by mechanical means:

  • Aerosol coating product means a pressurized coating product containing pigments or resins that dispenses product ingredients by means of a propellant, and is packaged in a disposable can for hand-held application, or for use in specialized equipment for ground traffic/marking applications.

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

  • Bulk drug substance means any substance that is represented for use, and that, when used in the

  • Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):

  • Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.

  • Milk product or "dairy product" means cottage cheese, dry curd cottage cheese, reduced fat cottage cheese, lowfat cottage cheese, cream, light cream, light whipping cream, heavy cream, heavy whipping cream, whipped cream, whipped light cream, sour cream, acidified sour cream, cultured sour cream, half-and-half, sour half-and-half, acidified sour half-and-half, cultured sour half-and-half, reconstituted or recombined milk and milk products, concentrated milk, concentrated milk products, skim milk, lowfat milk, frozen milk concentrate, flavored milk, eggnog, buttermilk, cultured milk, cultured lowfat milk, cultured skim milk, yogurt, lowfat yogurt, nonfat yogurt, acidified milk, acidified lowfat milk, acidified skim milk, low-sodium milk, low-sodium lowfat milk, low-sodium skim milk, lactose-reduced milk, lactose-reduced lowfat milk, lactose-reduced skim milk, aseptically processed and packaged milk, milk products with added safe and suitable microbial organisms, and any other milk product made by the addition or subtraction of milkfat or addition of safe and suitable optional ingredients for protein, vitamin, or mineral fortification. Unless a product is considered a milk product under this subdivision, milk product does not include dietary products, infant formula, ice cream or other desserts, cheese, or butter. Milk products include the following:

  • 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;