Companion Diagnostics definition

Companion Diagnostics and “Companion Diagnostic use” as the context requires, shall mean the use of Licensed Technology in Royalty Product(s) as part of a kit, a Laboratory developed Test or FDA-approved assay (or an equivalent approval from foreign regulatory agencies) for measurement, observation or determination of attributes, characteristics, disease, traits or other conditions of human beings in vitro with the purpose of predicting the likely clinical effectiveness and/or safety of a particular therapeutic intervention for a specific individual. Companion Diagnostics specifically excludes solely testing for the presence of disease or for disease screening or confirmation.
Sample 1Sample 2
Companion Diagnostics will mean a diagnostic product or service to the extent sold or used to determine whether to prescribe the Licensed Product to treat a human patient. For clarity, no covalent inhibitor (including the Lead Candidate or any Licensed Product) or occupancy probe against any of the Targets will be included within this definition.
Sample 1Sample 2
Companion Diagnostics has the meaning set forth in Section 5.15 (Development of Companion Diagnostics).
Sample 1

Examples of Companion Diagnostics in a sentence

  • Each payment of royalties due to Ambit shall be accompanied by a report showing the amount of gross sales of Companion Diagnostics during the applicable calendar year, a calculation of Net Sales, including details of the actual deductions from gross amount invoiced as provided for in the definition of Net Sales, the aggregate amount of […***…] incurred during such calendar year, and a calculation of the amount of royalty payment due for such calendar year.

  • Lxxxx shall have no right to use any trademark, tradename, or corporate name of Telix or any of its Affiliates with Companion Diagnostics.

  • As between the Parties, Telix shall be responsible for selecting, in its sole discretion, and shall own all right, title and interest in and to any trademarks adopted by Telix for use with the Licensed Products anywhere in the world (including all goodwill accruing with respect to such use), and shall be responsible for the registration, filing, maintenance and enforcement thereof, provided that the foregoing shall not apply with respect to Companion Diagnostics if Lilly has exercised its Option.

  • If Lilly exercises its Option, Lxxxx shall have the first right, but not the obligation, to commence, undertake or prosecute any Offensive Joint New Patent Infringement Action or, subject to Section 11.4(c)(v), negotiate or enter into any settlement or voluntary disposition of an Offensive Joint New Patent Infringement Action, with respect to, in either case, infringement of the exclusive rights with respect to Companion Diagnostics granted under Section 3.4(b).

  • From time to time, each of Bayer (or any of its Affiliates) and Compugen (or any of its Affiliates) may transfer biological materials to the other for purposes of the Research Programs and the development of Products and Product Companion Diagnostics.

  • If Lilly exercises its Option, as between the Parties, Lxxxx shall be responsible for selecting, in its sole discretion, and shall own all right, title and interest in and to any trademarks adopted by Lxxxx for use with the Companion Diagnostics anywhere in the world (including all goodwill accruing with respect to such use), and shall be responsible for the registration, filing, maintenance and enforcement thereof.

  • In addition, each party shall keep the JSC or JDC, as applicable, reasonably informed with respect to the Licensed Products, including the Development and Commercialization thereof (and, if applicable, Companion Diagnostics), by or under authority of such party, and provide to the JSC or JDC such information as may be reasonably requested with respect to the foregoing.

  • If Lilly exercises its Option, Lxxxx shall, subject to Section 11.4(c)(v), have the first right, but not the obligation, to defend and control the defense of any Defensive Joint New Patent Action relating to Lxxxx’x rights to Companion Diagnostics under Section 3.4(b).

  • The Parties are entering into a research and development collaboration for the Research Period, with the intent of developing CGEN-15001T Target Biologics and CGEN 15022 Target Biologics that will be candidates for the development of Products and of discovering and developing Target Biomarkers that can be used as research tools for the development of Products and/or for the development of Product Companion Diagnostics.

  • In addition, to the extent Telix or any Affiliate thereof owns any Regulatory Materials that relate solely to Companion Diagnostics, Telix shall provide Lilly all material information related thereto, and, if and as requested by Lxxxx, assign all right, title, and interest therein to Lilly or an Affiliate thereof, free and clear of all liens, claims, and encumbrances.


More Definitions of Companion Diagnostics

Companion Diagnostics and “Companion Diagnostic use” as the context requires, shall mean the use of Licensed Technology in Royalty Product(s) […***…] for […***…]. Companion Diagnostics specifically excludes […***…].
Sample 1
Companion Diagnostics means any diagnostic product or biomarker arising from work performed by ASET pursuant to the terms of this Agreement or otherwise derived from or based in whole or in part on MetaStat Intellectual Property.
Sample 1

Related to Companion Diagnostics

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

  • 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.

  • 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)).

  • Collaborative drug therapy management means participation by an authorized pharmacist and a physician in the management of drug therapy pursuant to a written community practice protocol or a written hospital practice protocol.

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

  • in vitro diagnostic medical device means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:

  • 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 school means a residential group living facility:

  • Hemp products means all products made from industrial hemp,

  • Commercializing means to engage in Commercialization and “Commercialized” has a corresponding meaning.

  • Research Use shall have the meaning given in Section 2.2.2 of this Agreement.

  • Product Manufacturer means the entity that assembles the component parts to manufacture the final Product;

  • Commercialized shall have corresponding meanings.

  • 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 Compound means [***].

  • 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 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.

  • Biomarker means a parameter or characteristic in a patient or Patient Sample, the measurement of which is useful (a) for purposes of selecting appropriate therapies or patient populations or monitoring disease susceptibility, severity or state, or monitoring therapies for such patient and/or (b) for predicting the outcome of a particular treatment of such patient.

  • Bioassay means the determination of kinds, quantities or concentrations and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body. For purposes of these rules, “radiobioassay” is an equivalent term.

  • Gene Therapy means the introduction of a nucleic acid sequence encoding a protein intended for or otherwise conferring therapeutic benefit into a person for therapeutic purposes (i) by in vivo introduction for incorporation into cells of such person, or (ii) by ex vivo introduction into cells for transfer into a person.

  • Commercialise means to promote, market, distribute, sell and/or otherwise commercialise a product, and Commercialising and Commercialisation shall be construed accordingly;

  • 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.

  • Medical marijuana product means a product that contains cannabinoids that have been extracted from plant material or the resin therefrom by physical or chemical means and is intended for administration to a licensed patient, including but not limited to concentrates, oils, tinctures, edibles, pills, topical forms, gels, creams, and other derivative forms, except that this term does not include live plant forms.

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

  • Licensed Services means all functions performed by the Licensed System.

  • Third Party Manufacturer means any person, firm or company which carries out the reproduction of Work and/or manufactures and/or prints the Licensed Publication on behalf of the Licensee;