Harmony Biosciences Holdings Inc. filed SEC Form 8-K: Entry into a Material Definitive Agreement, Other Events, Financial Statements and Exhibits
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Item 1.01 Entry into a Material Definitive Agreement.
The information under the heading “LCA Amendments” under Item 8.01. Other Events is incorporated in this Item 1.01 by reference.
Item 8.01 Other Events.
Exclusive Sublicense Agreement
On April 11, 2024, Harmony Biosciences Holdings, Inc. announced that its subsidiary Harmony Biosciences, LLC (“Harmony”) entered into a sublicense agreement with Bioprojet Société Civile de Recherche and Bioprojet Pharma SAS (“Bioprojet”) for an orexin-2 receptor agonist (OX2R) (the “Licensed Compound”) to be evaluated for the treatment of narcolepsy and potential other indications (the “Sublicense”). Under the Sublicense, Harmony obtained the exclusive right to develop, manufacture and commercialize the Licensed Compound in the U.S. and Latin American territories, which are rights that Bioprojet originally licensed from Teijin Pharma, the innovator of the Licensed Compound. The Licensed Compound is currently in pre-clinical development with an Investigational New Drug application currently anticipated in the second half 2025. Under the Sublicense, Harmony will pay Bioprojet an upfront license fee of $25.5 million and will also be obligated to pay up to $127.5 million upon achievement of development and regulatory milestones and up to $240.0 million upon achievement of sales-based milestones, as well as a royalty rate in the mid-teens on sales in the licensed territories.
LCA Amendments
In connection with the Sublicense, on April 6, 2024, Harmony and Bioprojet also entered into an amendment to that certain License and Commercialization Agreement originally entered into in July 2017 with Bioprojet (the “2017 LCA”) and an amendment to that certain License and Commercialization Agreement originally entered into in July 2023 with Bioprojet (the “2022 LCA”). The amendments to the 2017 LCA and the 2022 LCA removed the exclusivity of efforts provisions in those agreements allowing Harmony to expand the scope of its activities.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit |
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No. | Description | |
104 | Cover Page Interactive Data File (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.
HARMONY BIOSCIENCES HOLDINGS, INC. | ||
Date: April 11, 2024 | By: | /s/ Sandip Kapadia |
Sandip Kapadia | ||
Chief Financial Officer and Chief Administrative Officer | ||