Licensed Product Biomarker definition

Licensed Product Biomarker means any and all biomarkers (including metabolite, DNA, RNA and protein profiles) discovered or developed by or on behalf of AVEO or Pharmstandard during the Term that (a) are for use with (including use in clinical testing of or use in any decision whether to prescribe), or (b) relate to, are associated with or are correlated with patient populations who do or do not respond to treatment with, in the case of each of (a) and (b), any one (1) or more Licensed Product(s). For purposes of clarity, Licensed Product Biomarkers include biomarker tests for detecting and measuring levels of any of the biomarker molecules described in the preceding sentence, whether in the form of testing products, test kits or tests performed at a centralized testing laboratory. Any such biomarker or biomarker test is a Licensed Product Biomarker regardless of its stage of discovery, development, advancement or commercialization, and whether or not the biomarker or biomarker test is already validated or recognized by any Regulatory Authority. For purposes of this definition, biomarkers or biomarker tests “discovered or developed by or on behalf of AVEO or Pharmstandard” include those discovered or developed by AVEO’s or Pharmstandard’s respective Affiliates, Sublicensees or contractors.
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Examples of Licensed Product Biomarker in a sentence

  • Aveo shall be responsible, in the manner that it deems appropriate (subject to its obligations pursuant to Section 3.3 and complying with the information-sharing and other obligations set forth for it in this Agreement), for all further development of Licensed Products for, and commercialization (including marketing, promotion and sales) of Licensed Products in, the Aveo Territory for the Field (and all associated Licensed Product Biomarker development).

  • The furnishing Party shall also provide to the other Party any meeting minutes that reflect material communications with any Regulatory Authority regarding a Licensed Product or Licensed Product Biomarker within the Field, but will not be required to provide minutes or portions thereof that relate to communications regarding any product or biomarker outside the Field.

  • Neither Aveo nor Kirin shall in-license any intellectual property that contains subject matter relevant to any Licensed Product within the Field or to any Licensed Product Biomarker within the Field without first conferring with the other Party as to the application of the intellectual property being licensed.

  • Each of Aveo and Kirin shall have the right to use the records of the other Party for purposes of the development or commercialization of any Licensed Product or Licensed Product Biomarker (including the filing of Marketing Approval Applications) in its respective Territory during the Term.

  • In addition, each Party shall promptly furnish to the other Party copies of all correspondence that the furnishing Party (or its Affiliate, Sublicensee or Other Licensee) receives from, or submits to, any Regulatory Authority (including contact reports concerning conversations or substantive meetings) relating to any Licensed Product or Licensed Product Biomarker.

  • Aveo will be responsible for Licensed Product and Licensed Product Biomarker commercialization for the Aveo Territory in accordance with the annual, high-level Commercial Plans that Aveo will share with Kirin annually beginning in the year prior to launch.

  • However, each Party shall provide the other Party with reasonable advance notice of any meeting or substantive telephone conference with any Regulatory Authority relating to any Licensed Product or Licensed Product Biomarker with respect to the Field.

  • Neither Aveo nor Kirin shall in-license any intellectual property that contains subject matter relevant to any Licensed Product or Licensed Product Biomarker without first conferring with the other Party as to the application of the intellectual property being licensed.

  • To the extent permitted by law, Aveo shall transfer to Kirin all INDs, Marketing Approval Applications, Marketing Approvals and other regulatory filings related to any Licensed Compounds, Licensed Product or Licensed Product Biomarker that Aveo holds as of the time of such termination.

  • The furnishing Party shall also provide to the other Party any meeting minutes that reflect material communications with any Regulatory Authority regarding a Licensed Product or Licensed Product Biomarker.

Related to Licensed Product Biomarker

  • Licensed Product means any method, process, composition, product, service, or component part thereof that would, but for the granting of the rights set forth in this Agreement, infringe a Valid Claim contained in the Licensed Patents.

  • 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 a person or entity licensed to produce medical cannabis.

  • 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.

  • Licensed Compounds means any EZH2 Compound(s) that is:

  • Diagnostic Product means In Vitro Diagnostics, In Vivo Diagnostic Agents and any product used for Diagnosis.

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

  • Licensed Compound means (a) 3,4-Diaminopyridine, the chemical structure of which is set forth on Exhibit B-2; and (b) any derivatives, isomers, metabolites, prodrugs, acid forms, base forms, salt forms, or modified versions of such compound in (a).

  • Licensed Field means all fields of use.

  • Licensed Fields of Use means the fields of use identified in Appendix B.

  • 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.

  • complex product means a product which is composed of multiple components which can be replaced permitting disassembly and re-assembly of the product.

  • Hemp products means all products made from industrial hemp,

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

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

  • Licensed Territory means worldwide.

  • 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 System means, collectively:

  • 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.

  • Licensed Field of Use means all fields.

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

  • 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.

  • Combination Product means (a) a product containing a Licensed Product together with one or more other active ingredients that have independent biologic or chemical activity when present alone that are sold as a single unit, or (b) a Licensed Product together with one or more products, devices, pieces of equipment or components thereof, that are sold as a single package at a single price.

  • Roll-on product means any antiperspirant or deodorant that dispenses active ingredients by rolling a wetted ball or wetted cylinder on the affected area.

  • 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.

  • 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 or the active pharmaceutical contained in a Unity Bcl-2 [***] Product, and (b) has been placed on the market pursuant to a validly granted marketing authorization.