UNITED STATES
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Washington, D.C. 20549
FORM
CURRENT REPORT
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Item 1.01 | Entry into a Material Definitive Agreement. |
Commercialization and Distribution Agreement in Japan
Capricor Therapeutics, Inc. (the “Company” or “Capricor”) entered into an Exclusive Commercialization and Distribution Agreement (the “Japan Agreement”) with Nippon Shinyaku, Co., Ltd., a Japanese corporation, (“Nippon Shinyaku”) effective February 10, 2023. Under the terms of the Japan Agreement, Capricor appointed Nippon Shinyaku as its exclusive distributor in Japan, of CAP-1002, the Company’s lead product candidate, for the treatment of Duchenne muscular dystrophy.
Under the terms of the agreement, Capricor will receive an upfront payment of $12 million and in addition, Capricor will potentially receive additional development and sales-based milestone payments of up to approximately $89 million and a meaningful, double-digit share of product revenue. Nippon Shinyaku will be responsible for the distribution of CAP-1002 in Japan. Capricor will be responsible for the conduct of clinical development in Japan, as may be required, as well as the manufacturing of CAP-1002. Capricor will sell commercial product to Nippon Shinyaku. In addition, Capricor will hold the Marketing Authorization in Japan, if the product is approved in that territory.
The Company expects to file the Japan Agreement as an exhibit to its Annual Report on Form 10-K for the year ended December 31, 2022 and intends to seek confidential treatment for certain terms and provisions of the Japan Agreement. The foregoing description is a summary of the material terms of the Japan Agreement, does not purport to be complete, and is qualified in its entirety by reference to the text of the Japan Agreement when filed.
A copy of the press release is attached hereto as Exhibit 99.1.
Item 9.01Financial Statements and Exhibits.
(d) Exhibits
99.1 | ||
104 | Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101). |
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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.
CAPRICOR THERAPEUTICS, INC. | ||
Date: February 16, 2023 | By: | /s/ Linda Marbán, Ph.D. |
Linda Marbán, Ph.D. | ||
Chief Executive Officer | ||
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