SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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Item 1.01. Entry into a Material Definitive Agreement.
On October 16, 2021, MannKind Corporation (“MannKind”) and United Therapeutics Corporation (“United Therapeutics”) entered into an amendment (the “Amendment”) to the commercial supply agreement, dated August 12, 2021, by and between MannKind and United Therapeutics (the “Supply Agreement”) to, among other things, extend the term of the Supply Agreement and amend the non-renewal notification periods. Under the amended Supply Agreement, unless earlier terminated, the term of the Supply Agreement continues until December 31, 2031 and is thereafter renewed automatically for additional, successive two-year terms unless (i) United Therapeutics provides notice to MannKind at least 24 months in advance of such renewal that United Therapeutics does not wish to renew the Supply Agreement or (ii) MannKind provides notice to United Therapeutics at least 48 months in advance of such renewal that MannKind does not wish to renew the Supply Agreement.
The foregoing description of the material terms of the Amendment is qualified in its entirety by reference to the full text of the Amendment, a copy of which will be filed as an exhibit to a subsequent filing with the Securities and Exchange Commission.
Item 8.01. Other Events.
On October 18, 2021, MannKind issued a press release announcing that the U.S. Food and Drug Administration (“FDA”) issued a complete response to United Therapeutics regarding the New Drug Application (“NDA”) for Tyvaso DPI™ for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease. The FDA declined to approve the NDA at this time, noting only one deficiency related to an open inspection issue at a third-party analytical testing center for treprostinil, the active ingredient of Tyvaso DPI. The complete response did not pertain to MannKind, and no issues were cited by the FDA as it relates to MannKind’s facility in Connecticut for manufacture, testing and packaging of finished Tyvaso DPI, including its associated device.
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: October 18, 2021||By:|
|David Thomson, Ph.D., J.D.|
|Corporate Vice President, General Counsel and Secretary|