Item 2.03. Creation of a Direct Financial Obligation or an Obligation under an
Off-Balance Sheet Arrangement of a Registrant.
As previously reported, on July 28, 2017, Harmony Biosciences Holdings, Inc.
(the "Company") entered into a license and commercialization agreement (as such
agreement has been amended from time to time, the "License Agreement") with
Bioprojet Société Civile de Recherche ("Bioprojet"), which granted the Company
an exclusive, sublicensable license to commercialize, in the United States and
its territories, commonwealths, and protectorates, including Puerto Rico, a
product containing pitolisant currently known as WAKIX for narcolepsy,
obstructive sleep apnea, idiopathic hypersomnia, Parkinson's disease, and any
other indication agreed upon by the parties, which currently include
Prader-Willi Syndrome and Muscular Dystrophy (the "Field"), as well as rights to
related patent rights, know-how, trademarks, trade dress, regulatory filings and
approvals (the "Bioprojet Assets"). Bioprojet also granted to the Company a
co-exclusive (with Bioprojet), sublicensable license to Bioprojet Assets to
clinically develop and register the pitolisant product in the Field in the
United States. Bioprojet retained the right to manufacture the product in the
United States, and to develop outside the United States and commercialize other
products that contain pitolisant as an active ingredient anywhere in the world.
Bioprojet also granted to the Company an exclusive license to use certain
trademarks and trade names in connection with the commercialization of the
product under the Bioprojet License Agreement. In exchange for these rights
under the License Agreement, the Company agreed to pay to Bioprojet certain
milestone and royalty payments.
On October 13, 2020, the Company received notice that the U.S. Food and Drug
Administration ("FDA") approved the Company's new drug application ("NDA") for
the Company's product WAKIX for the treatment of cataplexy in adult patients
with narcolepsy. Pursuant to the License Agreement, upon FDA approval of a
cataplexy indication for WAKIX (the "Trigger Date"), the Company is obligated to
make a payment to Bioprojet of $2.0 million within 15 days of the Trigger Date
and a milestone payment to Bioprojet of $100.0 million within 90 days of the
Trigger Date. Accordingly, the Company plans to make both payments to Bioprojet
on or before their respective due dates.
Descriptions of the other material terms of the License Agreement are hereby
incorporated by reference to the Company's Registration Statement on Form S-1/A
filed with the Securities and Exchange Commission on August 13, 2020 (the
"Registration Statement"). The description of the License Agreement contained
herein does not purport to be complete, and is qualified in its entirety by
reference to the complete text of the License Agreement filed as Exhibit 10.1 to
the Company's Registration Statement.
Item 7.01. Regulation FD.
On October 14, 2020, the Company issued a press release entitled "Harmony
Biosciences Receives FDA Approval for Expanded Use of WAKIX (pitolisant) for the
Treatment of Cataplexy in Adult Patients with Narcolepsy," a copy of which is
furnished as Exhibit 99.1 hereto.
The information in Item 7.01 of this Current Report on Form 8-K, including
Exhibit 99.1, shall not be deemed to be filed for purposes of Section 18 of the
Securities Exchange Act of 1934 (the "Exchange Act"), or otherwise subject to
the liability of that section, and shall not be incorporated by reference into
any registration statement or other document filed under the Securities Act of
1933 (the "Securities Act"), except as shall be expressly set forth by specific
reference in such filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. Description
99.1* Press release issued by the Company dated October 14, 2020.
* This Exhibit is furnished herewith and will not be deemed "filed" for
purposes of Section 18 of the Exchange Act or deemed to be incorporated by
reference into any filing under the Exchange Act or the Securities Act except
to the extent that Harmony Biosciences Holdings, Inc. specifically
incorporates it by reference.
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