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.
On June 26, 2024 (the “Effective Date”), Unicycive Therapeutics, Inc. (the “Company”) entered into the First Amendment to Manufacturing and Supply Agreement with Shilpa Medicare, Ltd., an Indian corporation (“Shilpa”) (the “Amendment”). The Company and Shilpa are parties to that certain Manufacturing and Supply Agreement, dated as of October 31, 2020 (the “Agreement”) pursuant to which Shilpa provides certain development, manufacturing, supply and other CMC-related services related to the development and commercialization of oxylanthanum carbonate (“OLC”). The Company has entered into the Amendment in anticipation of an increased manufacturing demand for OLC.
Pursuant to the Amendment, the Company has agreed to make a binding purchase order for tablets of OLC and Shilpa has agreed to deliver such order by June 30, 2025. In addition, the Company has agreed to order additional tablets for delivery between December 31, 2025 and June 30, 2026. Further, the Company has agreed to provide certain funding to Shilpa for a new manufacturing line. The initial term of the Agreement shall continue until the eighth (8th) anniversary of the date of receipt by the Company of FDA approval of its NDA of OLC (the “Initial Term”). Following the Initial Term, the Agreement shall continue in effect for consecutive periods of four (4) years each unless earlier terminated pursuant to the terms of the Agreement.
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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 2, 2024
| UNICYCIVE THERAPEUTICS, INC. | ||
| By: | /s/ Shalabh Gupta | |
| Shalabh Gupta | ||
| Chief Executive Officer | ||
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