Product Cell Line definition

Product Cell Line means the cell line *** to express the Compound.
Product Cell Line means the […***…], within the meaning of the Clinical Supply Agreement.
Product Cell Line means the […***…].

Examples of Product Cell Line in a sentence

  • AstraZeneca agrees to comply with the terms and conditions of the Lead Product Cell Line License in connection with the Development, Manufacturing and Commercialization of the Lead Product as a sublicensee/Pieris Product Licensee under such License and to provide reasonable assistance and information to Pieris to ensure that Pieris complies with such License.

  • Notwithstanding the foregoing, to the extent that AstraZeneca sublicenses any rights granted under the Lead Product Cell Line License, it shall abide by the restrictions of such Lead Product Cell Line License.

  • Company shall ensure that (i) all quantities of Compound and Licensed Products are manufactured in compliance with applicable specifications and current good manufacturing practices in facilities which have and maintain all necessary approvals from the FDA, the Commission/EMA and/or other relevant Regulatory Authorities in the Territory; and (ii) any use or transfer of the Product Cell Line or Culture Cell Media is subject to, and at all times compliant, with Schedule 9.

  • Each Party shall comply with its obligations under the terms of the Product Cell Line License (including in connection with the Exploitation of the Product) and shall notify the other Party immediately if it becomes aware of any dispute under such agreement.

  • Each Party agrees to provide all reasonably requested assistance and information to the other Party to assist such other Party in its compliance with the Product Cell Line License.

  • For clarity, Biological Materials (as defined in the APA) shall not include any LB Materials or LB System Materials except if and to the extent that LB System Materials are incorporated into the Product Cell Line.

  • Within [***] days of receipt of the up-front payment in Section 8.1, Pieris shall assign the Product Cell Line License to BP as permitted under such License.

  • As between the Parties, BP shall be solely responsible for and, except for the one-time payment set forth in Exhibit 4.1, shall make all payments due in connection with the Product Cell Line License without offset or reduction to the payments due to Pieris under this Section 8.

  • The Parties acknowledge that the Manufacture the Product (as it exists as of the Effective Date) is subject to the Product Cell Line License.


More Definitions of Product Cell Line

Product Cell Line means the 551 Cell Line or the 7734 Cell Line as applicable and “Product Cell Lines” means both of them.

Related to Product Cell Line

  • Cell Line means the cell line, particulars of which are set out in Schedule 1.

  • 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.

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

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

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

  • Hemp products means all products made from industrial hemp,

  • Product Know-How means Know-How to the extent related to the properties, manufacture or use of any products.

  • 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:

  • 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.

  • Product Technology means the Product Know-How and Product Patents.

  • Bioassay means the determination of kinds, quantities or concentrations and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body. For purposes of these rules, “radiobioassay” is an equivalent term.

  • Licensed Compounds means: (a) Research Program Active Compounds; (b) Novartis Active Compounds; (c) salts, hydrates, solvates, esters, metabolites, intermediates, stereoisomers and polymorphs of Research Program Active Compounds or Novartis Active Compounds; and (d) prodrugs of Research Program Active Compounds or Novartis Active Compounds (any of the foregoing, a “Licensed Compound”).

  • Licensor Technology means the Licensor Patents, the Licensor Know-How, Licensor Materials, and Non-Patent Rights Controlled by Licensor or its Affiliates embodied in Licensor Know-How or Licensor Materials.

  • 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.

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

  • 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.

  • 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.”

  • Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms.

  • 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.

  • Spray buff product means a product designed to restore a worn floor finish in conjunction with a floor buffing machine and special pad.

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

  • Product Candidate means any pharmaceutical product developed, manufactured and/or tested by or on behalf of the Company that has not received a Regulatory Authorization for commercial distribution other than in connection with pre-clinical or clinical trials.

  • Licensed Technology means the Licensed Patents and the Licensed Know-How.

  • Licensed Compound means [***].

  • 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.

  • Program Materials means the documents and information provided by the Program Administrator specifying the qualifying EEMs, technology requirements, costs and other Program requirements, which include, without limitation, program guidelines and requirements, application forms and approval letters.