Development Milestone Event 4 definition

Development Milestone Event 4 means [****]. For this purpose “clearance by the FDA” means either (a) 30 days have passed since the filing with no clinical hold imposed, or issues raised, by the FDA so that the clinical trial can begin dosing, or (b) if the FDA has raised any issues, the issues have been resolved to the FDA’s satisfaction so that the clinical trial can begin dosing.
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Examples of Development Milestone Event 4 in a sentence

  • Upon Marketing Approval in the United States $ ​ In the event that the Marketing Approval for an Indication of a Licensed Product or Licensed Service (Development Milestone Event #4) is received prior to the achievement of any prior Development Milestone Event, then Licensee shall also pay the amount due for occurrence of all previous Development Milestone Events that had not previously been paid upon receiving such Marketing Approval.

  • Upon Marketing Approval in the United States $ ​ ​ In the event that the Marketing Approval for an Indication of a Licensed Product or Licensed Service (Development Milestone Event #4) is received prior to the achievement of any prior Development Milestone Event, then Licensee shall also pay the amount due for occurrence of all previous Development Milestone Events that had not previously been paid upon receiving such Marketing Approval.

  • Further, If Development Milestone Event 4 is achieved and Development Milestone Event 3 was skipped, then Development Milestone Event 3 will be deemed to have been achieved upon the achievement of Development Milestone Event 4.

  • In the event that the Marketing Approval for an Indication of a Licensed Product or Licensed Service (Development Milestone Event #4 or #5) is received prior to the achievement of any prior Development Milestone Event, then Licensee shall also pay the amount due for occurrence of all previous Development Milestone Events that had not previously been paid upon receiving such Marketing Approval.