Licensed Clinical Data definition

Licensed Clinical Data means the Elidel Licensed Clinical Data and the Xerese Licensed Clinical Data.
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Licensed Clinical Data means the Clinical Data Controlled by Oncolytics during the term of this Agreement which directly relates to the use of any Licensed Product in humans.
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Licensed Clinical Data means all data (including raw data) and results generated under the Sub-Study which relates to the Combination Therapy or the SpringWorks Compound as a sole compound, including any Sample Testing Results relating to the Combination Therapy or the SpringWorks Compound as a sole Compound, but excluding any data (including Sample Testing Results) relating to the GSK Compound alone or use of the GSK Compound in combination with any other compound in the Field.
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Examples of Licensed Clinical Data in a sentence

  • Both Valeant and Meda have the right to undertake development work (whether alone or together) in respect of products that fall within the scope of the Licensed Patents, Licensed Know-How or Licensed Clinical Data, in particular on any new formulations of such products.

  • If a Regulatory Authority requests that Licensee provide additional information regarding any Licensed Clinical Data, then the parties shall discuss the scope of such request and, if the requested information is owned or otherwise controlled by Licensor, Licensor shall provide such information to Licensee in a reasonable amount of time and cooperate with Licensee in responding to such request.

  • Further, if a Regulatory Authority makes any finding that impacts or could reasonably be expected to impact the Licensed Clinical Data, then Licensor shall provide Licensee with prompt written notice thereof and solicit (and reasonably consider) Licensee’s feedback regarding any plan for remedial action.

  • If the Parties are unable to identify a mutually acceptable Third Party manufacturer within sixty (60) days, then Meda shall grant to Valeant a sublicensable, non-exclusive license (or, as applicable, a non-exclusive sub-license) under the Xerese Licensed Patents, the Xerese Licensed Know-How and the Xerese Licensed Clinical Data solely for the purposes of manufacturing Xerese Licensed Product for Valeant.

  • Furthermore, Licensor does not represent or warrant that any Licensed Clinical Data was created for submission to any Governmental Authority.

  • For clarity, nothing in this Section 16.4(b) shall restrict or prevent GSK or SpringWorks from directly or indirectly, researching, developing or commercializing a GSK-Related Compound or SpringWorks-Related Compound, without the use of the Jointly Owned Sub-Study Inventions or the Licensed Clinical Data.

  • The reduced royalty shall be payable in respect of the continued use of the Licensed Know How and the Licensed Clinical Data and as a reasonable manufacturing margin.

  • Notwithstanding the foregoing, each Party shall have the right to practice each Jointly Owned Sub-Study Invention and the right to use the Licensed Clinical Data in performing its obligations and exercising its rights under this Agreement.

  • The royalties payable by Licensee to Oncolytics under Clause 10.5 in respect of a given Licensed Product shall be allocated [**] to the Oncolytics Patent Rights and [**] to the combined Licensed Clinical Data and Licensed Know How.

  • GSK shall use commercially reasonable efforts to obtain all patient authorizations and consents required under Data Protection Laws in connection with the Sub-Study to permit such sharing of Licensed Clinical Data with SpringWorks.


More Definitions of Licensed Clinical Data

Licensed Clinical Data means all tables, listings, figures and other aggregated analysis derived from the Clinical Data (in accordance with the applicable protocol for the relevant Clinical Study) that relates to the Combination Regimens or the SpringWorks Compound as a sole compound, but excluding any raw data (including Sample Testing Results) or any data (or any aggregated analysis thereof) relating to the GSK BCMA Product alone or use of the GSK BCMA Product in combination with any other compound in the Field. 1.74 “Manufacture,” “Manufactured,” or “Manufacturing” means all activities of the manufacture of a Compound, including planning, purchasing, manufacture, processing, compounding, storage, filling, packaging, waste disposal, labelling, leafleting, testing, quality assurance, sample retention, stability testing, release, dispatch and supply, as applicable. 1.75 “Manufacturer’s Release” or “Release” means the certification of release of a production lot of a Compound in accordance with the Clinical Quality Agreement. 1.76 “Manufacturing Site” means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 12.10. 1.77 “Material Safety Issue” means a Party’s reasonable belief that there is an unacceptable risk for harm in humans based on: (a) pre-clinical safety data, including data from animal toxicology studies, or (b) the observation of serious adverse events in humans after a Party’s Compound, either as a single Compound or in combination with any other
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