Companion Diagnostics definition

Companion Diagnostics means, with respect to a Licensed Product, (a) a companion diagnostic approved by the applicable Regulatory Authority that provides information essential to the safe and effective use of such Licensed Product or is otherwise necessary for the Regulatory Approval of such Licensed Product, or (b) a complementary diagnostic that provides information helpful to the safe and effective use of such Licensed Product but is not a companion diagnostic referred to in the foregoing provision (a).
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.
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.

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.

  • 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 L▇▇▇▇, assign all right, title, and interest therein to Lilly or an Affiliate thereof, free and clear of all liens, claims, and encumbrances.

  • 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.

  • If Lilly exercises its Option, L▇▇▇▇ 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).

  • 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.

  • Upon L▇▇▇▇’▇ exercise of its Option, the Parties shall use reasonable, good faith efforts to negotiate and enter into a reasonable amendment to the agreement executed pursuant to the first sentence of this Section 4.2(b) in order to ensure it properly addresses L▇▇▇▇’▇ Development, Manufacture, and Commercialization of Companion Diagnostics.

  • If Lilly exercises its Option, as between the Parties, L▇▇▇▇ shall be responsible for selecting, in its sole discretion, and shall own all right, title and interest in and to any trademarks adopted by L▇▇▇▇ 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.

  • 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.

  • 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.

  • 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.


More Definitions of Companion Diagnostics

Companion Diagnostics has the meaning set forth in Section 5.18 (Development 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 […***…].
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.

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)).

  • 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 an assemblage of reagents, including but not limited to reagents packaged in the form of a kit, useful in performing a Licensed Service.