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 December 1, 2022, Liquidia PAH, LLC, a Delaware limited liability company (“Liquidia PAH”), a wholly-owned subsidiary of Liquidia Corporation, a Delaware corporation (the “Company”), entered into a Device Development and Supply Agreement (the “Pump Development Agreement”) with Mainbridge Health Partners, LLC (“Mainbridge”) and Sandoz Inc. (“Sandoz”).
The Pump Development Agreement provides for the cooperation between Liquidia PAH, Sandoz and Mainbridge to develop a new pump that is suitable for the subcutaneous administration of treprostinil. Mainbridge will perform all development, validation and testing activities required for the pump and related consumables.
Under the Pump Development Agreement, Liquidia PAH and Sandoz will provide Mainbridge with product requirements for the pump and related consumables, and have the right to review proposed protocols for verification testing and human factor testing and the results of all such testing.
The Pump Development Agreement also provides that the parties anticipate submitting a 510(k) clearance application for the pump to the U.S. Food and Drug Administration in 2023.
Liquidia PAH and Sandoz will split all development costs and milestone payments under the Pump Development Agreement in accordance with the terms and conditions set forth therein.
The foregoing description of the Pump Development Agreement does not purport to be complete and is qualified in its entirety by reference to the complete terms and conditions of the Pump Development Agreement to be filed as an exhibit to the Company’s next Form 10-K to be filed with the Securities and Exchange Commission (the “SEC”).
Item 8.01 | Other Events. |
On December 5, 2022, Liquidia Corporation, a Delaware corporation (the “Company”), issued a press release announcing the collaboration between the Company, Sandoz and Mainbridge to develop the new pump for the subcutaneous administration of treprosinil pursuant to the Pump Development Agreement. A copy of the press release is filed as Exhibit 99.1 hereto and is incorporated by reference into this Item 8.01.
Item 9.01 | Financial Statements and Exhibits. |
(d) | Exhibits. |
Exhibit No. |
Exhibit | |
99.1 | Press Release of Liquidia Corporation, dated December 5, 2022. | |
104 | Cover Page Interactive Data File (the cover page tags are embedded within the Inline XBRL document). |
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.
December 5, 2022 | Liquidia Corporation | ||
By: | /s/ Michael Kaseta | ||
Name: | Michael Kaseta | ||
Title: | Chief Financial Officer |