Companion Diagnostic Product definition

Companion Diagnostic Product has the meaning set forth in Section 10.4.2(c).
Companion Diagnostic Product means a product used as a companion product to a Collaboration CAR-T Product or a Licensed Product for the purpose of assessing applicability of the Collaboration CAR-T Product or Licensed Product to a specific individual.
Companion Diagnostic Product means an activated progesterone receptor biomarker diagnostic product and its methods of use, including its use in conjunction with therapies involving the API, as disclosed and claimed in the PATENT RIGHTS, which is approved for use in the TERRITORY.

Examples of Companion Diagnostic Product in a sentence

  • Notwithstanding anything contained in this Section 10.5, no sales event payments shall be paid to Pieris in the event that a Product is itself developed, used and commercialized as a Companion Diagnostic Product or as a Stand-alone Diagnostic Product.

  • Novartis will (i) remain responsible for conducting and completing development of the NRAS Melanoma Companion Diagnostic Product (the “NRAS Companion Diagnostic”) until Post Marketing Approval from the FDA (the “PMA”) and (ii) until such PMA approval by the FDA and [*], support submission and approval in such other countries where approval of the NRAS Companion Diagnostic is required for the approval of Binimetinib or products containing Binimetinib.

  • Any Net Sales resulting from the Commercial Sale of a Companion Diagnostic Product shall be added to the Net Sales with the respective Pharmaceutical Product, and royalties shall accrue on the Net Sales of such Companion Diagnostic Product according to the provisions and applicable royalty rates for the respective Pharmaceutical Product as set forth in this Agreement.

  • Notwithstanding anything contained in this Section 10.6, no royalty payments shall be paid to Pieris in the event that a Product is itself developed, used and commercialized as a Companion Diagnostic Product.


More Definitions of Companion Diagnostic Product

Companion Diagnostic Product has the meaning set forth in Section 11.5.2 (License to Ionis for Companion Diagnostic Products).
Companion Diagnostic Product means a medical device, often an in vitro device (IVD), that provides Information that is essential for the safe and effective use of a Compound or Product.
Companion Diagnostic Product means a Diagnostic Product that provides information that is essential for the safe and effective use of a Pharmaceutical Product for which it is sold, i.e. that is used to determine whether a particular Pharmaceutical Product’s benefits to patients will outweigh any potential serious side effects or risks. For the avoidance of doubt, when the use of a Diagnostic Product is required by a Regulatory Authority in the labeling of a Pharmaceutical Product, e.g. for selection of appropriate patients for therapy, or to select patients who should not use the Pharmaceutical Product, or for monitoring patients to achieve safety or effectiveness, use of the Diagnostic Product is considered “essential” for the purposes of this definition. Uses of Diagnostic Products that are suggested but not required in Pharmaceutical Product labeling are not considered “essential”.

Related to Companion Diagnostic Product

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

  • Companion Diagnostic means a device which is essential for the safe and effective use of a corresponding medicinal product to:

  • 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.

  • 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.

  • Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;

  • Licensed Compound means [***].

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • 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”).

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

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

  • 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.

  • Combination Product means any combination of the Product with one (1) or more other active ingredients, products or services that is not the Product, where such products are sold either as a fixed dose/unit or as separate doses/units in a single package for a single price.

  • 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.

  • 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.

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

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Licensed Program means the executable processing programs of licensed information, which is composed of various modules in the Licensed Software package provided by the Licensor.

  • U.S. Territory means American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, or the U.S. Virgin Islands.

  • Commercialized shall have corresponding meanings.

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

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

  • 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 Territory means worldwide.

  • 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.

  • Lead Compound means any compound of lead other than galena which, when treated in the manner described below, yields to an aqueous solution of hydrochloric acid a quantity soluble lead compound exceeding, when calculated as lead monoxide, five percent of the dry weight of the portion taken analysis.

  • Licensed Programs means, collectively, NeoSystems’ and any Third Party Vendor computer software programs to be provided to Client for use on certain hardware on Client’s premises or a third party’s premises as set forth in an Agreement. The Licensed Programs shall include any fixes, work-arounds, updates, revisions, modifications, enhancements and any derivative works that are provided to Client by NeoSystems under an Agreement.