Sandoz Product definition

Sandoz Product means Argatroban® 125mg/125m1 as described on Schedule A.
Sandoz Product means [*].“Territory” means the United States, United States of America and its territories and possessions, including the Commonwealth of Puerto Rico and the District of Columbia. License Effective Date March 4, 2030 unless [*], in which case the License Effective Date will automatically become [*]. License Subject to the terms and conditions of this Term Sheet, Adamas hereby grants to the Sandoz ANDA Holder (and to the extent necessary, their Affiliates, suppliers, distributors, manufacturers, customers and assignees, as the case may be) a non-exclusive, fully paid, non-transferable license under the Licensed Patents, with no right to sublicense (the “License”), to: (a) make or have made the Sandoz Product inside or outside the Territory [*] and solely for use, sale and offer for sale of the Sandoz Product in the Territory on or after the License Effective Date; (b) import the Sandoz Product into the Territory [*] and solely for use, sale, and offer for sale of the Sandoz Product in the Territory on or after the License Effective Date; and (c) to use, sell, and offer to sell the Sandoz Product in the Territory as of the License Effective Date. Premarketing Rights Xxxxxx authorizes Sandoz to [*] its Sandoz Product to potential customers [*] prior to the License Effective Date but only for sales that will occur on or after the License Effective Date.
Sandoz Product will mean a bivalrudin product covered by an Abbreviated New Drug Application (“ANDA”) owned or controlled by Sandoz or one of its Affiliates.

Examples of Sandoz Product in a sentence

  • Sandoz will use Commercially Reasonable efforts to (i) market, distribute and sell both the Sandoz Product and the AG Product in the Territory during the Supply Term, and (ii) [*] Net Sales of both the Sandoz Product and the AG Product in the Territory during the Supply Term.

  • Moreover, nothing in this Agreement shall preclude or prevent Sandoz from marketing, distributing, offering to sell or selling the Sandoz Product.

  • Sandoz [*] the Sandoz Product or the AG Product [*], then [*], the [*] shall [*].

  • Sandoz will have independent, sole discretion to determine the pricing, terms of sale, marketing, and selling decisions for the Sandoz Product and AG Product without any consultation with, input from, or prior notice to Eagle.

  • Sandoz (or an Affiliate of Sandoz), pursuant to the terms of this Agreement and the Settlement Agreement, would like to (i) purchase AG Product from Eagle and then distribute the AG Product in the Territory, and (ii) distribute the Sandoz Product.

  • For Section 5.2(i): a monthly breakdown of (i) gross sales, (ii) gross to net items and units, (iii) Net Sales for AG Product and Sandoz Product, and (iv) the volume of units of Sandoz Product sold.

  • Innovator will replace, at its own cost and expense, including reimbursement of reasonable freight and disposition costs incurred by Sandoz, Product that fails to comply with the Specifications for such Product.

  • For Section 5.2(ii): a quarterly breakdown of (i) gross sales, (ii) gross to net items and units, (iii) Net Sales for AG Product and Sandoz Product, and (iv) the volume of units of Sandoz Product sold.

  • Exhibit A Form of NPS Report For Section 5.2(i): a monthly breakdown of (i) gross sales, (ii) gross to net items and units, (iii) Net Sales for AG Product and Sandoz Product, and (iv) the volume of units of Sandoz Product sold.

  • Xxxxxx agrees to cooperate reasonably with the Sandoz ANDA Holder to effectuate the selective waiver of regulatory exclusivity detailed herein, including providing notices to the FDA verifying the existence of such selective waiver and not opposing the FDA’s final approval of the Sandoz ANDA for sale of the Sandoz Product in the Territory as of the Orphan Drug Date.


More Definitions of Sandoz Product

Sandoz Product means an injectable acetaminophen product having a dosage amount of 1000 mg/100 ml (10 mg/ml) in finished dosage form that is the subject of the Sandoz ANDA. “Territory” means the United States of America, including its territories, possessions, and commonwealths. “Third Party” means any Person other than a Party or its Affiliates. License Subject to the terms and conditions of this Term Sheet and the Settlement Agreement, Cadence hereby grants to Sandoz ANDA Holder (and to the extent necessary, their Affiliates, suppliers, distributors, manufacturers, customers and assignees, as the case may be) a non-exclusive, fully paid, non-transferable sublicense under the Licensed Patents, with no right to sublicense (the “License”), to: (a) Manufacture the Sandoz Product inside or outside the Territory not earlier than [***] and solely for Marketing the Sandoz Product in the Territory [***]; (b) Import the Sandoz Product into the Territory not earlier than [***] and solely for Marketing the Sandoz Product in the Territory [***]; and (c) Market the Sandoz Product in the Territory [***]. *** Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.
Sandoz Product means any and all of the Company’s rights in and to (a) treprostinil injection (therapeutic equivalent to Remodulin®) as approved by the FDA for sale in the United States under Abbreviated New Drug Application No. 203649 owned by Sandoz Inc., and (b) any other “Product”, as such term is defined under the Sandoz Agreement.

Related to Sandoz Product

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

  • 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.

  • 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.

  • Licensed producer means an agent, broker, or reinsurance intermediary licensed pursuant to the applicable provision of the insurance law of any jurisdiction.

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

  • Royalty Product means, either (a) an Alnylam Royalty Product, or (b) an Inex Royalty Product.

  • 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.

  • 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.

  • Hemp products means all products made from industrial hemp,

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

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

  • Licensed Compound means [***].

  • Generic Product means a product which (a) contains as its active pharmaceutical ingredient a compound that is (or is substantially the same as) the Licensed Compound, and (b) has been placed on the market pursuant to a validly granted marketing authorization.

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

  • 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”).

  • 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:

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

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

  • 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;

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

  • 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.

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

  • 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.”

  • 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.

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