GMP Product definition

GMP Product means a Licensed Product that (a) is a eukaryotic cell or eukaryotic cell line, the genome or genetic composition of which has been modified through the use (whether directly or indirectly) of a ZFP Product in a manner that (i) facilitates or improves the ability of such cell or cell line to produce a Therapeutic Product or (ii) modifies the molecular characteristics of such Therapeutic Product and (b) is not a Plant Product.”
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GMP Product means Product that is intended for use for clinical applications as opposed to non-clinical research and development purposes.
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GMP Product means the Product from or in the GMP Batch.
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Examples of GMP Product in a sentence

  • Lubrizol agrees to manufacture GMP Product at its Manufacturing Facility according to current good manufacturing practices [***], or, if such guide is updated in a subsequent published version, the most recent version (“GMP”).

  • The Parties acknowledge that that either Party may identify a GMP Product defect, or otherwise raise a concern about GMP Product integrity, safety, quality, or regulatory compliance that requires a GMP Product modification to meet applicable requirements imposed by a Regulatory Authority as a condition to obtain or maintain Regulatory Approval for an IDDS Product, and which may necessitate a change in Specifications (each a “Required Improvement”).

  • The Parties intend for the GMP Product to be used by Braeburn, or an IDDS Commercial Partner, as an Excipient in an IDDS Product that contains one or more other components as API, and, accordingly, that Lubrizol shall only be required to meet Regulatory Authority manufacturing requirements applicable to Excipients.

  • Lubrizol shall notify Braeburn of any Significant Change to the manufacturing procedures or processes for GMP Product.

  • Except as provided in Section 2.6, during the Term and subject to the terms and conditions in this Agreement, Braeburn shall exclusively purchase from Lubrizol, and Lubrizol shall supply to Braeburn, all of Braeburn’s requirements for GMP Product in the Field of Use for (a) use in clinical trials for IDDS Products, and (b) use in the manufacture of IDDS Products (collectively, the “‘GMP Supply”).

  • Lubrizol is responsible for complying with all FDA and applicable foreign regulatory requirements pertaining to the receipt, review, evaluation, and, where applicable, investigation of all complaints received pertaining to GMP Product.

  • Lubrizol shall cooperate fully with Braeburn in addressing Braeburn’s customer complaints that relate to GMP Product and shall take such action to CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”.

  • Braeburn represents and warrants to Lubrizol as of the Effective Date and during the Term that Braeburn will only use GMP Product -and not use Non-GMP Product - for use in any IDDS Product that is intended for use in any human clinical trial or for commercial sale to be administered for human use.

  • Commissioner Tingerthal stated that the Agency will be working with an energy fellow during the next year, adding that the energy fellow is very aware of the work being done by Fresh Energy and the Council.

  • The Parties agree to work in good faith to implement any changes to the manufacture of GMP Product that may be necessary to support Regulatory Approval.


More Definitions of GMP Product

GMP Product means [***].
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GMP Product. Product that is manufactured according to GMP and the Specification;
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Related to GMP Product

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

  • Licensed Product means a product, method or service in the Licensed Field of Use, the making, having made, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent.

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

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • 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.

  • Hemp products means all products made from industrial hemp,

  • Licensed producer means a person or entity licensed to produce medical cannabis.

  • 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.”

  • Licensed Compound means [***].

  • Generic Product means any pharmaceutical product that (i) is sold by a Third Party that is not an Affiliate or licensee of Buyer and (ii) (a) contains the same active pharmaceutical ingredient as the Product or (b) is categorized by the applicable Governmental Entity in a country to be therapeutically equivalent to, or interchangeable with, the Product, such that the pharmaceutical product may be substituted for the Product at the point of dispensing without any intervention by the prescribing physician in such country.

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

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

  • Bundled Product means Product sold together with any other product(s) or service(s) at a single unit price, whether packaged together or separately, and which other product(s) or service(s) have material independent value from Product itself.

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

  • 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:

  • Final Product means a product that is not used in producing other products and is built and intended for use outdoors, provided the final product has not deteriorated or has otherwise become a potential source of contaminants.

  • complex product means a product which is composed of multiple components which can be replaced permitting disassembly and re-assembly of the product.

  • 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;

  • Licensed Products means tangible materials which, in the course of manufacture, use, sale, or importation, would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable, invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction.

  • Cannabis product 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.

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.

  • Diagnostic Product means any test or assay for diagnosing or detecting a disease, disorder, medical condition, or symptom.

  • Roll-on product means any antiperspirant or deodorant that dispenses active ingredients by rolling a wetted ball or wetted cylinder on the affected area.

  • Licensed Compounds means any EZH2 Compound(s) that is:

  • Edible cannabis product means cannabis product that is intended to be used, in whole or in part, for human consumption, including, but not limited to, chewing gum, but excluding products set forth in Division 15 (commencing with Section 32501) of the Food and Agricultural Code. An edible cannabis product is not considered food, as defined by Section 109935 of the Health and Safety Code, or a drug, as defined by Section 109925 of the Health and Safety Code.

  • Combination Product means any product that comprises a Licensed Compound or Licensed Product sold in conjunction with another active component so as to be a combination product (whether packaged together or in the same therapeutic formulation).