Aphthasol Product definition

Aphthasol Product means a topical oral paste formulation containing Amlexanox currently approved by the FDA for use in the treatment of aphthous ulcers;
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Examples of Aphthasol Product in a sentence

  • After the Closing Date, Block and its Affiliates shall promptly submit to Access all Adverse Experience information or customer complaints brought to the attention of Block or its Affiliates in respect of the Aphthasol Product, as well as any material events and matters concerning or affecting the safety or efficacy of the Aphthasol Product.

  • Notwithstanding the foregoing, the Parties agree that ten (10) business days prior to the effective date of the expiration, or earlier termination by Access (as provided herein), of the Transition Period, Block shall cease accepting or placing any new orders for the Aphthasol Product in the U.S. Block shall retain any proceeds received from its sales of the Aphthasol Product during the Transition Period.

  • Access agrees that during the Transition Period, Block shall be permitted to notify existing customers for the Aphthasol Product, in a form agreed to by Access, of the consummation of the transactions contemplated by this Agreement.

  • Except as disclosed on Schedule 6.4 or as would not have a Material Adverse Effect, Block has not received any written notice of violation of any applicable law, regulation or requirement relating to the Aphthasol Product, the Purchased Assets or the Takeda License Agreement within the past three (3) years.

  • In such written accounting to Takeda, Access agrees that it shall use the balance of the aggregate license fee payments existing as of the Closing Date that have been paid to Takeda by Chemex and Block since November 12, 1987 in accordance with Section 7.1 of the Takeda License Agreement, to offset any and all royalties payable to Takeda on Block's Net Sales (as defined in the Takeda License Agreement) of Aphthasol Product during the Transition Period.

  • Beginning on the Closing Date, Access shall have all responsibility for required reporting of Adverse Experiences for the Aphthasol Product, Mucositis Product and other Dermatological Product.

  • On or prior to the Closing Date, Block shall provide Access with all information relating to the investigation and reporting of Adverse Experiences regarding the Aphthasol Product since three (3) years prior to the Closing Date and all information which is relevant to the safe use of the Aphthasol Product as of the Closing Date and will confer with Access on Adverse Experience history related to the Aphthasol Product.

  • Block has conducted and is currently conducting the manufacturing, processing, packaging, labeling, marketing and sale of the Aphthasol Product in the United States in compliance with all applicable laws, rules, regulations and court or administrative orders and processes.

  • To knowledge of Block, no other Intellectual Property or license is required in order to sell the Aphthasol Product in the United States.

  • Except for the Excluded Assets and as otherwise stated herein (including, without limitation, in Schedule 6.11) or in the Aphthasol Supply Agreement or as would not cause a Material Adverse Effect, the Purchased Assets include all property, rights, assets, information, files and materials necessary for Access to develop, manufacture, sell and distribute the Aphthasol Product in a manner substantially similar to Block's practices as of the Closing Date.

Related to Aphthasol Product

  • 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.”

  • 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.

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

  • 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;

  • Nicotine product means a product that contains nicotine and is not any of 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.

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

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

  • Tobacco product means any substance containing tobacco leaf, including but not limited to, cigarettes, cigars, pipe tobacco, hookah tobacco, snuff, chewing tobacco, dipping tobacco, bidis, blunts, clove cigarettes, or any other preparation of tobacco; and any product or formulation of matter containing biologically active amounts of nicotine that is manufactured, sold, offered for sale, or otherwise distributed with the expectation that the product or matter will be introduced into the human body by inhalation; but does not include any cessation product specifically approved by the U.S. Food and Drug Administration for use in treating nicotine or tobacco dependence.

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

  • 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.

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

  • Hemp products means all products made from industrial hemp,

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

  • Marihuana-infused product means a topical formulation, tincture, beverage, edible substance, or similar product containing marihuana and other ingredients and that is intended for human consumption.

  • 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:

  • 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.

  • 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.

  • Pharmaceutical Product shall have the meaning ascribed to such term in Section 3.1(hh).

  • 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.

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

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

  • Existing Product means any formulation of the same product category and form sold, supplied, manufactured, or offered for sale in California prior to the following dates, or any subsequently introduced identical formulation:

  • Active Pharmaceutical Ingredient or “API” means the active pharmaceutical substance of the Drug in bulk form prior to incorporation into the Product.

  • Marijuana products means concentrated marijuana products and marijuana products that are comprised of marijuana and other ingredients and are intended for use or consumption, such as, but not limited to, edible products, ointments, and tinctures.

  • 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.