First Indication Milestone Payments Clause Samples
The First Indication Milestone Payments clause defines the financial obligations that arise when a specific developmental or regulatory milestone is achieved for the first therapeutic indication of a product. Typically, this clause outlines the timing, amount, and conditions under which the milestone payment is triggered, such as upon successful completion of a clinical trial phase or regulatory approval for the initial use of the product. Its core function is to incentivize progress in product development and ensure that the party responsible for achieving key milestones is compensated, thereby aligning interests and managing financial risk between the parties.
First Indication Milestone Payments. Within *** following the first achievement of each milestone specified below by the Product for the first Indication to reach such milestone during the course of the Development of the Product, Licensee shall make the following respective milestone payment to Bayer: Milestone Payment Signature of an informed consent form by a patient in a Phase III Clinical Trial $ *** Submission of an NDA in the US $ *** Submission of an NDA Equivalent in the EU $ *** Submission of an NDA Equivalent in Japan $ *** Approval of NDA in the US $ *** Approval of NDA Equivalent in the EU $ *** Approval of NDA Equivalent in Japan $ ***