Item 5. Other Information
Item 5. Other Information.
On July 31, 2022, Harmony entered into that certain License and Commercialization Agreement (the “2022 LCA”) with Bioprojet whereby Harmony obtained exclusive rights to manufacture, use and commercialize one or more new products based on pitolisant, in the United States and Latin America, with the potential to add additional indications and formulations upon agreement of both parties. Harmony will pay an upfront, non-refundable $30 million licensing fee as well as additional payments of up to $150 million due under the 2022 LCA upon the achievement of certain future development and sales-based milestones. In addition, there are certain payments due upon achievement of development milestones for new indications and formulations agreed upon by both parties. The 2022 LCA also requires a fixed trademark royalty and a tiered royalty based on net sales upon commercialization, which will be payable to Bioprojet on a quarterly basis. The closing of the 2022 LCA is contingent upon clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and other customary closing conditions.
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Item 6. Exhibits.
Exhibit
Incorporated by Reference
No.
Exhibit Description
Form
Date
Number
3.1
Amended and Restated Certificate of Incorporation of Harmony Biosciences Holdings, Inc.
8-K
August 21, 2020
3.1
3.2
Amended and Restated Bylaws.
8-K
August 21, 2020
3.2
31.1*
Certification of Chief Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) of the Securities Exchange Act of 1934, as amended, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2*
Certification of Chief Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) of the Securities Exchange Act of 1934, as amended, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1**
Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2**
Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101*
The following financial statements from the Company ’ s Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2022 formatted in Inline XBRL: (i) Balance Sheets, (ii) Statements of Operations, (iii) Statements of Stockholders ’ Equity and (vi) Notes to Financial Statements, tagged as blocks of text and including detailed tags.
104*
Cover Page Interactive Date File (formatted as Inline XBRL and contained in Exhibit 101)
*
Filed herewith.
**
Furnished herewith. This certification is deemed furnished, and not filed, with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Harmony Biosciences Holdings, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Quarterly Report on Form 10-Q, irrespective of any general incorporation language contained in such filing.
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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, thereunto duly authorized.
HARMONY BIOSCIENCES HOLDINGS, INC.
By:
/s/ John C. Jacobs
Name:
John C. Jacobs
Title:
President, Chief Executive Officer and Director (principal executive officer)
Date:
August 2, 2022
By:
/s/ Sandip Kapadia
Name:
Sandip Kapadia
Title:
Chief Financial Officer (principal financial officer)
Date:
August 2, 2022
38
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.