Significant Improvements definition

Significant Improvements means any improvements which either (a) comprise such significantly new scope that new clinical trial(s) (i.e., more than a single equivalency trial) would be required, or (b) whose incorporation in the license rights granted herein would require the payment of new fees or royalties to third parties. Significant Improvements does not include minor improvements, such as formulation, affinity, vector function, or shelf half-life, for which no new clinical trial (other than a single Product equivalency trial) is required.
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Examples of Significant Improvements in a sentence

  • Borrower Parties may make alterations and/or improvements to the Properties which are not Significant Improvements without the prior consent of Agent.

  • After approval by City of the documents pertaining to the Significant Improvements described in Section 5.02 of this lease, any substantial change in the plans or specifications for the Significant Improvements shall be approved by the City.

  • Two 24-Week Phase 3 Studies of Lumacaftor in Combination with Ivacaftor Met Primary Endpoint with Statistically Significant Improvements in Lung Function (FEV1) in People with Cystic Fibrosis who have Two Copies of the F508del Mutation.

  • District shall complete construction of each of the Significant Improvements no later than twelve (12) years after commencement of this lease.

  • City may agree to extend the time for completion of the Significant Improvements in writing for good cause.