NME Declaration definition

NME Declaration means, with respect to a Licensed Product, a decision by Poseida or any of its Affiliates or Sublicensees to select a Licensed Product for entry into any Pre-Phase I study wherein said decision must be reasonably supported by objective scientific evidence. For purposes of this definition, “Pre-Phase I studies” include toxicological, pharmacological and any other studies, the results of which are required for filing of an IND.
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Examples of NME Declaration in a sentence

  • Upon (a) NME Declaration with respect to the Licensed Product for which Poseida makes an NME Declaration and (b) IND filing with respect to all other Licensed Products, Poseida will provide ▇▇▇▇▇▇▇ with a written overview of the development plan for such Licensed Product, which will include reasonable descriptions regarding planned development activities and estimated timelines with respect to such Licensed Product.

  • License Agreement – August 3, 2015 Declaration hereunder during the NME Declaration Period and (b) to use the Licensed Technology for sustained application of research and Development activities to obtain Licensed Products.

  • By: /s/▇▇▇▇ ▇▇▇▇▇▇ Name: ▇▇▇▇ ▇▇▇▇▇▇ Title: V.P. Finance & CFO Country Serial No. Filed Status [**] The Research Plan provides an outline of research activities that will potentially be conducted by AVEO and COBI during the Research Term, consisting of research to support an NME Declaration and translational research to guide clinical development for the ▇▇▇ program.

  • Country Serial No. Filed Status [**] [**] [**] [**] [**] [**] [**] [**] The Research Plan provides an outline of research activities that will potentially be conducted by AVEO and COBI during the Research Term, consisting of research to support an NME Declaration and translational research to guide clinical development for the ▇▇▇ program.