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CURRENT REPORT
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Item 1.02 | Other Events. |
On June 6, 2023, Eagle Pharmaceuticals, Inc. (the “Company”) delivered notice (the “Notice”) of termination to AOP Orphan Pharmaceuticals GmbH (“AOP”) with respect to that certain license agreement, dated August 6, 2021, by and between the Company and AOP Orphan (the “AOP License”) following AOP’s receipt of a complete response letter from the U.S. Food and Drug Administration (“FDA”) whereby the FDA refused to approve AOP’s New Drug Application for landiolol. The Notice provides that the AOP License be terminated effective immediately.
As previously disclosed, pursuant to the AOP License, AOP granted the Company an exclusive royalty-bearing license under certain patent rights and know-how to develop, commercialize and otherwise exploit any pharmaceutical product that contains landiolol, a short-acting, intravenous, cardio-selective beta-1 adrenergic blocker product candidate for the short-term reduction of ventricular rate in patients with supraventricular tachycardia, in the United States. Pursuant to the AOP License, the Company made an upfront payment of $5 million in 2021, and the AOP License provided for potential additional payments upon regulatory approval(s) and based upon commercial sales.
The Company cannot be certain that AOP will not dispute the Company’s Notice or on what terms any potential dispute may be resolved.
The foregoing description of the AOP License is not complete and is qualified in its entirety by reference to the full text of the AOP License, a copy of which is filed as Exhibit 10.36 to the Company’s Annual Report on 10-K for the fiscal year ended December 31, 2022 and is incorporated by reference herein.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Dated: June 9, 2023 | EAGLE PHARMACEUTICALS, INC. | ||
By: | /s/ Scott Tarriff | ||
Scott Tarriff | |||
Chief Executive Officer |