Licensed Product Biomarkers definition

Licensed Product Biomarkers means any and all biomarkers (including metabolite, DNA, RNA and protein profiles) discovered or developed by or on behalf of Aveo or Kirin 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 and/or tumors that 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). Such a biomarker is a Licensed Product Biomarker regardless of its stage of discovery, development, advancement or commercialization, and whether or not the biomarker is already validated or recognized by any Regulatory Authority. Such biomarkers “discovered or developed by or on behalf of Aveo or Kirin” include those discovered or developed by Aveo’s or Kirin’s respective Affiliates, Sublicensees or contractors. To avoid any doubt, as used throughout this Agreement, “methods of testing for the presence of any Licensed Product Biomarkers” includes assays for the presence of such Licensed Product Biomarkers, including any that may be employed in either Party’s clinical testing of any Licensed Product or that may be referred to in the labeling for any Licensed Product in connection with Marketing Approval thereof anywhere in the world, and any items necessary or useful to conduct such assays in the same manner as in such clinical testing or as referred to in such Marketing Approvals.
Sample 1

Examples of Licensed Product Biomarkers in a sentence

  • Other respondents who suggested procuring and installing ideal and proper critical care nursing equipment to help improve competencies were 7.4% (n=7).

  • As between the Parties, Aveo is also responsible for all costs relating to development and commercialization of Licensed Product Biomarkers for the Aveo Territory, including manufacturing, regulatory, clinical and registration costs.

  • Each of Aveo and Kirin represents, warrants and covenants that in the course of the development of Licensed Products or Licensed Product Biomarkers, such Party has not prior to the Effective Date used, and shall not during the Term use, any employee or consultant who has been debarred by the FDA or Regulatory Authorities, or, to the best of such Party’s knowledge, who was or is the subject of debarment proceedings by the FDA or Regulatory Authorities.

  • At Kirin’s election, effective upon such a termination Aveo shall grant to Kirin an exclusive, world-wide, fully paid, royalty-free license to use trademarks owned or controlled by Aveo and used solely in connection with the commercialization of Licensed Compounds, Licensed Products, and Licensed Product Biomarkers in the Aveo Territory.

  • Short Term Disability Plan, as herein set forth and as it may be amended from time to time.

  • Each Party shall keep the other Party informed on an ongoing basis at Development Committee meetings regarding its (or its Affiliate’s, Sublicensee’s or Other Licensee’s) regulatory strategy, planned regulatory submissions and material communications with Regulatory Authorities with respect to all Licensed Products and Licensed Product Biomarkers in its respective Territory in the Field.

  • Aveo shall also have the right to conduct trials of or with Licensed Product Biomarkers in the Kirin Territory, subject to the prior written consent of Kirin, such consent not to be unreasonably withheld, delayed or conditioned.

  • At such time as Kirin intends to commence development of Licensed Products in the Field in the Kirin Territory, Kirin shall prepare and provide to Aveo a Kirin Annual Development Plan covering the activities Kirin, its Affiliates or Other Licensees intend to undertake with respect to the development of Licensed Products in the Field and/or Licensed Product Biomarkers in the Field in the Kirin Territory during the first annual period of such activities.

  • Aveo is expected to bring to bear in these activities both Aveo’s expertise in clinical development of oncology drug candidates, and its platform Human Response Prediction™ technology (which may enable it to identify Licensed Product Biomarkers that could aid in Licensed Product clinical testing; the Human Response Prediction™ technology is described on Aveo’s website as of the Effective Date).

  • It is understood that a Party’s obligation to provide summaries under this Section 2.5 can be fulfilled by providing a copy of the annual report describing clinical development with respect to Licensed Products and Licensed Product Biomarkers conducted by or on behalf of such Party, that such Party (or others acting under its authority, including Sublicensees and Other Licensees) provides to Regulatory Authorities in its Territory (each an “Annual Regulatory Report”).

Related to Licensed Product Biomarkers

  • 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, method or service in the Licensed Field of Use, the making, having made, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent.

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

  • Licensed Compound means [***].

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

  • Licensed Field means all fields of use.

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

  • Licensed Territory means worldwide.

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

  • 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 Field of Use means all fields.

  • Licensed System means, collectively:

  • Hemp products means all products made from industrial hemp,

  • 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.

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

  • 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.

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

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

  • 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.

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

  • processed products means goods placed under a processing procedure which have undergone processing operations;

  • Existing Product means any formulation of the same product category and form sold, supplied, manufactured, or offered for sale in California prior to the following dates, or any subsequently introduced identical formulation:

  • Marijuana product means marijuana as defined in 50-32-101 and marijuana-infused products