IDX HCV Product definition

IDX HCV Product means an Idenix HCV Product.
Sample 1
IDX HCV Product means an Idenix HCV Product. Scope Supply Idenix would supply Novartis with, and Novartis would purchase from Idenix, clinical supply of the applicable IDX HCV Products for use in HCV Combination Clinical Trials in accordance with the terms of a Clinical Supply Agreement to be executed by the Parties (the “Clinical Supply Agreement”). Manufacture Idenix would be responsible, directly or through its Affiliates and/or Third Party manufacturers, to perform certain manufacturing operations, including sourcing of components and API, production, and testing and release, storage and packaging for shipment of such IDX HCV Products to Novartis. Notwithstanding anything to the contrary herein, Novartis would be solely responsible for the labelling, storage, secondary packaging and shipment to third parties, including but not limited to clinical sites, of such IDX HCV Products for use in HCV Combination Clinical Trials. Notwithstanding anything to the contrary in this Term Sheet or the Clinical Supply Agreement, (a) the Parties may agree to ship IDX HCV Product under quarantine, and (b) the Parties agree and acknowledge that certain of the IDX HCV Product to be supplied to Novartis will have been manufactured prior to Idenix’ receipt of the relevant firm order for such IDX HCV Product and therefore certain provisions hereunder (including, without limitation, those requiring Novartis’ approval of the Third Party manufacturer and such other provisions to be agreed to by the parties in the Clinical Supply Agreement) are inapplicable to such IDX HCV Product. Subcontracting Idenix may subcontract the manufacture of the IDX HCV Products to a Third Party, subject to the approval of Novartis, not to be unreasonably withheld or delayed. Idenix will remain fully liable for the performance of any such Third Party manufacturer. The Clinical Supply Agreement will include a schedule of approved Third Party manufacturers. Facility The IDX HCV Products would be manufactured by Idenix or its Affiliates (or a Third Party manufacturer) exclusively at a facility reasonably acceptable to Novartis, and subject to inspection as described below. Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote omissions. REACH To the extent applicable to the manufacture of IDX HCV Products for an HCV Combination Clinical Trial, Idenix would ensure that it performs applicable registrations as required under Regulation (EC) No. 1907/2006 of the ...
Sample 1

Examples of IDX HCV Product in a sentence

  • Idenix will provide a Certificate of Analysis with each release in accordance with the specifications for the IDX HCV Product.

  • Supply Security Continuous supply and non-supply Idenix will supply IDX HCV Product to Novartis for the relevant HCV Combination Trial pursuant to Novartis’ firm orders.

  • Personal data provided by the interested party will be kept for 10 years from the time at which the final payment is made to the school.

  • Shelf Life Upon delivery, the IDX HCV Products’ residual shelf life would be sufficient for the length of the relevant HCV Combination Clinical Trial, as described in the Development Plan, for which Novartis placed the firm order for such IDX HCV Product.

  • If Idenix uses a Third Party manufacturer to manufacture the relevant IDX HCV Product, Idenix would, at Novartis’ expense, allow Novartis and regulatory authorities to audit and inspect the manufacturer’s facility in the same manner as provided above.

  • Validation Idenix undertakes to qualify and validate the equipment and manufacturing process and the manufacturing facility for the applicable IDX HCV Product to the extent required for the applicable stage of the HCV Combination Clinical Trial.

  • Failure Investigations Idenix will investigate any non-conforming IDX HCV Product or other deviation relating to the manufacture of the IDX HCV Product.

  • Quality Systems Compliance The Parties will enter into a quality agreement (the “Quality Agreement”) appropriate for the supply of IDX HCV Product for the HCV Combination Clinical Trials, which will include without limitation the relevant requirements set forth in this Term Sheet.

  • Ordering and delivery procedures Forecast The Development Plan shall include an initial non-binding [**] month forecast of the number of units of IDX HCV Product required for the applicable HCV Combination Clinical Trial.

  • Annual price review With respect to IDX HCV Product manufactured by Idenix or its Affiliates, a review of COGs shall take place at least once per year and take into account changes in the manufacturing cost of the IDX Products as well as savings realized, which may include savings due to improved manufacturing procedures and higher yields, and other factors mutually-agreed between the Parties.

Related to IDX HCV Product

  • 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.

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

  • 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.

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

  • 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.

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

  • Licensed Compound means [***].

  • 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:

  • 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.

  • 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.

  • 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.

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

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

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

  • Biosimilar Product means, with respect to a Licensed Product in any country, any biosimilar product sold by a Third Party not authorized by or on behalf of Celgene, its Affiliates or Sublicensees, (a) that is a biosimilar biological product, as defined in 21 USC 379j-51 (or any successor or replacement thereof), a similar biological medicinal product, as defined in Annex I to Directive 2001/83/EC (or any successor or replacement thereof), or any similar biosimilar or generic product under the Laws of any country or jurisdiction, or (b) regarding which Regulatory Approval is obtained by referencing Regulatory Data of such Licensed Product.

  • 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.

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

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

  • 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.

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

  • 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.

  • 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.”