Approval Payment definition
Examples of Approval Payment in a sentence
In no event will any Regulatory Approval Payment Amount become payable after the Regulatory Approval Payment Target Date, nor will any Milestone Payment Amount become payable on account of sales of the Product consummated after June 30, 2024.
On or before the fifth Business Day following (i) any FDA Payment Trigger Date and (ii) July 1, 2019, Parent will deliver to the Rights Agent a notice (the “FDA Approval Payment Notice”) indicating whether FDA Product Approval was achieved, and if achieved, whether FDA Preferred Product Label Approval was achieved.
Notwithstanding Section 5.4.1, if Iterum has elected to defer the payment of a Regulatory Approval Payment pursuant to Section 5.4.1, and if the first Change of Control of Iterum occurs during the two (2) year period described [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
For avoidance of doubt, any failure to make such Regulatory Approval Payment that is deferred as set forth in this Section 5.4.1 by the end of the applicable [ * ] period shall be a material breach of this Agreement subject to Section 13.2.
Any Regulatory Approval Payment deferred under this Section 5.4.1 shall bear interest at an annual rate of eight percent (8%) on a daily compounded basis until paid in full.
On or before the fifth Business Day following (i) any Sales Milestone Trigger Date and (ii) July 1, 2024, unless prior to such date one or more Regulatory Approval Payment Notices was delivered to the Rights Agent indicating both FDA Preferred Product Label Approval and EMA Preferred Product Label Approval had been achieved, Parent will deliver to the Rights Agent a notice (the “Milestone Notice”) indicating whether a Sales Milestone was achieved.
If the Onyx Drug Approval Payment amount has been paid to the Escrow Agent and has become part of the Escrow Amount, but (a) the Onyx Drug Approval Payment Date has not occurred by December 31, 2016, or (b) an event occurs which renders it substantially unlikely that the Onyx Drug Approval will occur by December 31, 2016 (e.g., a nonapproval letter from the FDA), then the Escrow Agent shall (in accordance with the terms of the Escrow Agreement) deliver the Onyx Drug Approval Payment amount to Parent.
A one-time payment of the EU Approval Payment payable in accordance with Section 1.17.
Within [*] calendar days following EU Approval, Acquiror shall concurrently (i) pay the EU Approval Payment to the Exchange Agent (for distribution to the Company Securityholders) and (ii) deliver a written notice to the Securityholders’ Representative Committee of the EU Approval (with supporting documentation).
If POZEN has not delivered the Regulatory Filing Transfer Letter to the FDA within [* * *] days following the NDA Approval for the Initial Products, unless such failure to deliver is caused by any action or inaction of Licensee, then Licensee may delay payment of the NDA Approval Payment by [* * *].