Regulatory Milestone Events definition

Regulatory Milestone Events has the meaning ascribed to such term in Section 1.02.
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Regulatory Milestone Events has the meaning set forth in Section 9.2.1 (Regulatory Milestones).
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Regulatory Milestone Events has the meaning set forth in Section 3.3. 1.105
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Examples of Regulatory Milestone Events in a sentence

  • If Otsuka or its Affiliates or Sublicensees achieve all of the Regulatory Milestone Events, then the Regulatory Milestone Payments payable by Otsuka under this Section 9.2.1 (Regulatory Milestones) will not exceed $[***].

Related to Regulatory Milestone Events

  • Milestone Events has the meaning set forth in Section 3.3 (Milestone Payments).

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.