Companion Diagnostics definition

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 Amended and Restated Strategic License Agreement inhibitor (including the Lead Candidate or any Licensed Product) or occupancy probe against any of the Targets will be included within this definition.
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Companion Diagnostics has the meaning set forth in Section 5.15 (Development of Companion Diagnostics).
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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 […***…]. ***Confidential Treatment Requested
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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.

  • After the date of termination (except in the case of termination by Compugen for Bayer’s failure to make payments when due), Bayer, its Affiliates and Sublicensees may sell Products and Companion Diagnostics then in stock; provided that Bayer shall pay the applicable royalties and payments to Compugen in accordance with Section 6 and provide reports and audit rights to Compugen pursuant to Section 7.

  • 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.

  • 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.

  • 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.

  • A Party may disclose the other Party’s Confidential Information to a Regulatory Authority to the extent such disclosure is required to comply with applicable governmental regulations or to conduct preclinical or clinical studies related to its Collaboration Compounds or Licensed Products, and other compounds that meet the Compound Criteria for, and are directed to, its Draft Pick Targets, and related Companion Diagnostics.

  • The Parties will discuss in good faith the role and responsibility that BN may have in connection with the Development of such Companion Diagnostics including whether BN will make available for BMS’s use in connection with same, subject to applicable privacy laws and the terms under which same were provided to BN, any patient samples and related clinical data and other materials possessed and Controlled by BN.

  • For avoidance of doubt, if this Agreement is terminated only as to one or more Arcus Programs and not in its entirety, then from and after such termination, the terminated Arcus Program shall no longer be deemed an Arcus Program, and the Licensed Products and Companion Diagnostics therefor within such Arcus Program shall be Terminated Products and shall no longer be deemed Licensed Products or Companion Diagnostics, for all purposes of this Agreement.

  • At BPM’s request, the Parties will include provisions in such Supply Agreements relating to the manufacture and supply of Companion Diagnostics or Roche Marketed Products for use with Licensed Products for Program 2 and Program 4.

  • As of and after the Effective Date, subject to the terms and conditions of this Agreement and applicable provisions of the Master Agreement, the Parties will assume through the Committees joint responsibility for, and control of, the Development and Commercialization of the Shared Products and Companion Diagnostics for such Shared Products in the Field in the Territory for U.S. Administration, under the Development Plan and the U.S. Commercialization Plan, respectively.


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) 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.
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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.
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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 any and all activities undertaken at any time for a particular Licensed Product and that relate to the manufacturing, marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of the Licensed Product, and interacting with Regulatory Authorities regarding the foregoing.

  • 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)).

  • Diagnostic Services means services provided for the purpose of determining the nature and cause of a condition, ill- ness, or injury.

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

  • 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.

  • 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 any EZH2 Compound(s) that is:

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

  • 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.

  • Gene Therapy means a product or service for the treatment or prevention of a disease that utilizes ex vivo or in vivo delivery (via viral or nonviral gene transfer methods or systems) of Genetic Material, including any cell incorporating Genetic Material.

  • Commercialise means to promote, market, distribute and/or sell 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.

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

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