Manufacturing Quota definition

Manufacturing Quota means the amount of an API allotted to Noramco by the DEA pursuant to applicable DEA regulations so that Noramco may manufacture API.
Manufacturing Quota means the amount of API allotted to Mallinckrodt by the DEA pursuant to applicable DEA regulations so that Mallinckrodt may manufacture such API, as such allocation may be updated from time to time.
Manufacturing Quota means the amount of a Product allotted to Supplier by the DEA pursuant to applicable DEA regulations so that that Supplier may manufacture Product.

Examples of Manufacturing Quota in a sentence

  • Seller shall not be held liable to Buyer for any loss, cost, damage, expense, inconvenience or any other consequences that may arise from any Manufacturing Interruption or Manufacturing Quota Restriction.

  • In the event that a Party has not obtained the necessary Manufacturing Quota or Procurement Quota, as the case may be, to allow it fully to perform its obligations under this Agreement, such Party shall promptly inform the other Party in writing.

  • Without limiting the foregoing, Mallinckrodt further agrees to use its commercially reasonable efforts to: (i) minimize interruptions in the supply of API to Osm Kft; and (ii) mitigate against the consequences of any shortages of Manufacturing Quota.

  • Cancellation of such Purchase Order shall be Buyer’s sole and exclusive remedy due to a Manufacturing Quota Restriction.

  • Any requested increases to the DEA Procurement Quota, DEA Manufacturing Quota and DEA Aggregate Production Quota shall be subject to the approval of the DEA and shall be sought in accordance with DEA regulations, rules and procedures.

  • For the avoidance of doubt, any allocation of Manufacturing Quota pursuant to this Section 2.7 shall not limit Osm Kft’s remedies with respect to a Supply Failure as long as such allocation is not in response to a Force Majeure Event.

  • Notwithstanding anything to the contrary that may be set forth herein, the Parties acknowledge and agree that: (i) Mallinckrodt’s obligation to supply API to Osm Kft hereunder is subject to the availability of sufficient Manufacturing Quota; and (ii) Osm Kft’s obligation to purchase any amounts of API from Mallinckrodt hereunder is subject to the availability of sufficient Procurement Quota.

  • For the avoidance of doubt, any allocation of Manufacturing Quota pursuant to this Section 2.6.3 shall not constitute a Supply Failure.

  • If Seller believes that a Manufacturing Quota Restriction is reasonably likely to result in a material reduction, suspension or delay in the delivery of Product to Buyer, Seller shall promptly consult with Buyer.

  • In the event of any cancellation of a Purchase Order as a result of insufficient Manufacturing Quota, Osm Kft shall pay to Mallinckrodt an amount equal to any Conforming API Delivered to Osm Kft pursuant to such cancelled Purchase Order prior to the date Mallinckrodt is informed in writing of such cancellation.


More Definitions of Manufacturing Quota

Manufacturing Quota means the amount of quota allotted to Noramco by the DEA pursuant to applicable DEA regulations so that Noramco may manufacture API.

Related to Manufacturing Quota

  • 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;

  • 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.

  • 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 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.

  • 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.

  • Manufacturing Process means any process for—

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

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

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

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

  • 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 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.

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

  • 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.

  • Marijuana product means marijuana as defined in 50-32-101 and marijuana-infused products

  • 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.

  • 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.

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

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • 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.

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

  • 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.

  • Licensed Product means a product or part of a product in the Licensed Field of Use: (A) the making, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent; or (B) which is made with, uses or incorporates any Technology.

  • 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.

  • 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.

  • Supply Licence means the licence granted to us under section 6(1)(d) of the Act;