Other Information.
−Removed: 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.
−Removed: 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.
−Removed: In addition, there are certain payments due upon achievement of development milestones for new indications and formulations agreed upon by both parties.
−Removed: 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.
−Removed: 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.
+Added: Not applicable.
Incorporated by Reference
4 unchanged sentences
August 21, 2020
+Added: License and Commercialization Agreement dated July 31, 2022, by and between Bioprojet Societe Civile de Recherche and Harmony Biosciences, LLC.
+Added: Amendment No.
+Added: 1 to Credit Agreement, dated as of August 2, 2022, among Harmony Biosciences, Inc., as Borrower, Harmony Biosciences, LLC, as Guarantor, the Guarantors from time to time party thereto, the Lenders from time to time party thereto, and Wilmington Trust National Association, as Administrative Agent.
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.
4 unchanged sentences
Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
−Removed: 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:
+Added: The following financial statements from the Company ’ s Quarterly Report on Form 10-Q for the fiscal quarter ended September 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.
4 unchanged sentences
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.
+Added: Certain portions of this document that constitute confidential information have been redacted in accordance with Regulation S-K, Item 601(b)(10).
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.
1 unchanged sentence
President, Chief Executive Officer and Director (principal executive officer)
−Removed: August 2, 2022
+Added: November 1, 2022
/s/ Sandip Kapadia
1 unchanged sentence
Chief Financial Officer (principal financial officer)
−Removed: August 2, 2022
+Added: November 1, 2022
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.