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IV Product definition

IV Product means the sulopenem antibiotic being developed by Iterum for intravenous delivery.
IV Product means the sulopenem antibiotic being developed by the Parent Guarantor for intravenous delivery.
IV Product means any Daptomycin Product formulated for intravenous delivery, including without limitation the formulation described by the specifications set forth in a letter that Cubist has provided to Gilead prior to the Effective Date.

Examples of IV Product in a sentence

  • Kamada shall fulfill all regulatory requirements relating to the safety of the A1PI IV Product, including, but not limited to, collecting and assessing adverse events, reporting safety information (individual case safety reports and aggregate reports), literature searches, risk management activities, if warranted, responding to regulatory inquiries and conducting pharmacovigilance for the A1PI IV Product.

  • In the event the BLA Party determines that any Remedial Action with respect to the A1PI IV Product should be commenced, or Remedial Action is required by any governmental authority having jurisdiction over the matter, the BLA Party shall use Commercially Reasonable Efforts to conduct such Remedial Action.

  • Each Party shall immediately notify the other Party of any information it receives regarding any threatened or pending action, inspection or communication by or from any party, including, without limitation, a Regulatory Authority which may affect the safety or efficacy claims of the A1PI IV Product or the continued marketing of the A1PI IV Product.

  • The application of spray pollination treatment was carried out in the morning at 9.00 WITA.

  • With respect to all other countries in the Xxxxxx Territory, Xxxxxx shall be responsible, at its sole cost and expense, for all pharmacovigilance and adverse event reporting activities for A1PI IV Product in such countries; provided, however, that Kamada shall reasonably assist Xxxxxx by providing relevant documentation for such A1PI IV Product.

  • In the event that Xxxxxx is not manufacturing or distributing the A1PI IV Product and is using third parties to manufacture or distribute the A1PI IV Product, Xxxxxx shall obtain all rights necessary from such third parties to enable Kamada to exercise all of its rights under this Agreement at such third party manufactures’ facilities.

  • Xxxxxx shall be responsible for obtaining, and undertakes to obtain using its Commercially Reasonable Efforts, and maintaining all regulatory, administrative, and third party payor-related activities relating to pricing and reimbursement approvals for the A1PI IV Product in the Xxxxxx Territory (and any country therein).

  • In furtherance of this right, Xxxxxx agrees that it shall specifically obtain from any and all third-party or Affiliate distributors of the A1PI IV Product a right of Kamada to conduct audits of such party’s records and facilities as set forth herein.

  • After the Initial Term, either party may terminate this Agreement with a minimum thirty (30) days prior written notice to the other party.

  • Kamada shall, at its discretion, have the right to attend any Xxxxxx meetings with the FDA, ISO or any other federal, state or local regulatory agency that relate to the A1PI IV Product in the Xxxxxx Territory.


More Definitions of IV Product

IV Product means the Product formulated for intravenous administration.
IV Product means any Product that is formulated to be administered intravenously.
IV Product means all injectable and intravenous dosage forms of Vernakalant.

Related to IV Product

  • Licensed Product means any pharmaceutical product containing a Licensed Compound (alone or with other active ingredients), in all forms, presentations, formulations and dosage forms.

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

  • Collaboration Product means any pharmaceutical product in finished form that contains a Collaboration Compound, either as the sole active ingredient or in combination with one or more other active ingredients, and all present and future formulations, dosages and dosage forms thereof.

  • 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.

  • Licensed Compound means a TAK-385 Licensed Compound or a TAK-448 Licensed Compound.

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

  • Diagnostic Product means an assemblage of reagents, including but not limited to reagents packaged in the form of a kit, useful in performing a Licensed Service.

  • 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.

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

  • 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”).

  • 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.

  • 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.”

  • 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;

  • 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.

  • Biosimilar Product means, with respect to a Licensed Product and on a country-by-country basis, a product that [***].

  • Covered Product The consumer product that You purchased concurrently with and is covered by this Agreement.

  • Competing Product means [***].

  • Bundled Product means a Licensed Product sold or bundled together with other products.

  • Nicotine product means the same as that term is defined in Section 76-10-101.

  • 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.

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

  • 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:

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

  • 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.

  • 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.