UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM
CURRENT REPORT
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Item 1.01 Entry into a Material Definitive Agreement
Unicycive Therapeutics, Inc. (the “Company”) entered into a License Agreement (the “Agreement”) effective as of July 14, 2022 with Lee’s Pharmaceutical (HK) Limited (“Lee’s Pharma”) pursuant to which the Company licensed the exclusive right to develop, market and commercialize Renazorb® to Lee’s Pharma in Mainland China, Hong Kong and certain other Asia markets. Under the terms of the agreement, Lee’s Pharma will be responsible for development, registration filing and approval for Renazorb® in the licensed territories. In addition, Lee’s Pharma will have sole responsibility for the importation of the drug product from Unicycive and for the costs of commercialization of Renazorb® in the licensed territories.
The Company will receive an upfront payment of $1 million upon execution of the Agreement and up to $1 million in milestone payments upon product launch in China and will be eligible for tiered royalties upon achievement of prespecified regulatory and commercial achievements. The term of the Agreement shall continue in effect until ten (10) years from the date of the first commercial sale in any country in the territory. Thereafter the Agreement shall be renewed automatically for succeeding terms of one year each unless either party provides six months prior written notice of termination.
The foregoing summary of the Agreement is qualified in its entirety by reference to the Agreement attached as Exhibit 1.1 hereto and is incorporated herein by reference.
Item 8.01 Other Events.
On July 18, 2022, the Company issued a press release announcing that the Company entered into the Agreement. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated by reference herein.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits.
| 10.1* | License Agreement effective as of July 14, 2022 by and between Unicycive Therapeutics, Inc. and Lee’s Pharmaceutical (HK) Limited |
| 99.1 | Press Release of Unicycive Therapeutics, Inc. dated July 18, 2022. |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
| * | Portions of this exhibit (indicated by asterisks) have been redacted in compliance with Regulation S-K Item 601(b)(10)(iv). |
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SIGNATURE
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: July 18, 2022
| UNICYCIVE THERAPEUTICS, INC. | ||
| By: | /s/ Shalabh Gupta | |
| Shalabh Gupta | ||
| Chief Executive Officer | ||
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