UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 1.01 | Entry into a Material Definitive Agreement. |
On February 22, 2023, ARS Pharmaceuticals, Inc. (the “Company”) entered into a Termination Agreement (the “Termination Agreement”) with Recordati Ireland, LTD. (“Recordati”), pursuant to which, among other things, the Company and Recordati agreed to terminate that certain License and Supply Agreement, dated September 21, 2020, by and between the Company and Recordati (the “License and Supply Agreement”).
Pursuant to the Termination Agreement, the Company will reacquire from Recordati all of its rights in and to an exclusive, royalty-bearing, sublicensable license under its patents relating to neffy to (i) perform Recordati’s development activities on the epinephrine compositions (“Licensed Compositions”) and related products (“Products”) for commercialization in the E.U., United Kingdom, and certain countries in the Middle East, Africa and Eurasia (the “Territory”), (ii) manufacture (or have manufactured) the Products for commercialization in the Territory, (iii) file and hold regulatory approvals for the Products in the Territory, and (iv) commercialize the Products in the Territory.
Under the Termination Agreement, the Company agreed to pay Recordati a one-time upfront payment of €3.0 million and Recordati is eligible to receive (i) an European Medicines Agency regulatory milestone payment of €2.0 million, (ii) a milestone payment of €5.0 million upon first commercial sale of a Product in the Territory, and (iii) milestone payments of up to €5.0 million in the aggregate from sales of Product(s) in the Territory.
The foregoing summary of the Termination Agreement does not purport to be a complete description of the document and is qualified in its entirety by the Termination Amendment, which the Company intends to file as an exhibit to the Company’s Annual Report on Form 10-K for the year ended December 31, 2022.
| Item 1.02 | Termination of a Material Definitive Agreement. |
On February 22, 2023, the Company entered into the Termination Agreement with Recordati, pursuant to which, among other things, the Company and Recordati agreed to terminate the License and Supply Agreement, effective immediately.
A description of the material terms of the License and Supply Agreement was included under the heading “License and Supply Agreement with Recordati Ireland” under Item 1.01 of the Current Report on Form 8-K filed by the Company on November 8, 2022 (the “2022 Form 8-K”), which is incorporated herein by reference. A description of the material terms of the Termination Agreement are included under Item 1.01 of this Current Report on Form 8-K and is incorporated herein by reference.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: February 22, 2023 | ARS Pharmaceuticals, Inc. | |||||
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By: | /s/ Richard Lowenthal, M.S., MSEL | ||||
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Name: | Richard Lowenthal, M.S., MSEL | ||||
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Title: | President and Chief Executive Officer | ||||