SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 31, 2022
DARÉ BIOSCIENCE, INC.
(Exact name of registrant as specified in its charter)
|Delaware|| ||001-36395|| ||20-4139823|
|(State or other jurisdiction|
| ||(I.R.S. Employer|
3655 Nobel Drive, Suite 260
San Diego, CA 92122
(Address of Principal Executive Offices and Zip Code)
Registrant’s telephone number, including area code: (858) 926-7655
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
|☐||Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)|
|☐||Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)|
|☐||Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))|
|☐||Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))|
Securities registered pursuant to Section 12(b) of the Act:
|Title of each class||Trading Symbol(s)||Name of each exchange on which registered|
|Common stock||DARE||Nasdaq Capital Market|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
|Item 1.01||Entry into a Material Definitive Agreement.|
On March 31, 2022, Daré Bioscience, Inc. ("Daré"), entered into an exclusive license agreement (the “Agreement”) with an affiliate of Organon & Co., Organon International GmbH (“Organon”), pursuant to which Organon will obtain exclusive worldwide rights to develop, manufacture and commercialize XACIATOTM [zah-she-AH-toe] (clindamycin phosphate vaginal gel, 2%) and other future intravaginal or urological products for human use formulated with clindamycin that rely on intellectual property controlled by Daré. XACIATO was approved by the U.S. Food and Drug Administration in December 2021 for the treatment of bacterial vaginosis in female patients 12 years of age and older.
Under the Agreement, Daré will receive a $10.0 million non-refundable and non-creditable payment following the effective date of the Agreement and will be entitled to receive tiered double-digit royalties based on net sales and up to $182.5 million in milestone payments as follows: $2.5 million following the first commercial sale of a licensed product in the United States, which is expected to occur during the fourth quarter of 2022; and up to $180.0 million in tiered commercial sales milestones and regulatory milestones. Royalty payments will be subject to customary reductions and offsets. The royalty period for each licensed product will continue on a country-by-country basis from the first commercial sale of the licensed product in the country until the expiration of the later of (i) the date that no valid patent claim would be infringed in the absence of the license granted under the Agreement by the sale of the licensed product in the country, (ii) 10 years after the end of the month in which the first commercial sale of the licensed product in the country occurred, and (iii) the expiration of regulatory market exclusivity for the licensed product in that country.
Under the Agreement, Daré will be responsible for regulatory interactions and for providing product supply on an interim basis until Organon assumes such responsibilities. Until such time, Organon will purchase all of its product requirements of XACIATO from Daré at a transfer price equal to Daré’s manufacturing costs plus a single-digit percentage markup.
The effective date of the Agreement will occur following the satisfaction of closing conditions that include receipt of all applicable approvals, or the expiration or termination of all applicable waiting periods, required under applicable antitrust laws, including the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended. Unless terminated earlier, the Agreement will expire on a product-by-product and country-by-country basis upon expiration of the applicable royalty period for each licensed product. In addition to customary termination rights for both parties, following the first anniversary of the effective date of the Agreement, Organon may terminate the Agreement in its entirety or on a country-by-country basis at any time in Organon’s sole discretion on 120 days’ advance written notice.
The Agreement includes customary representations and warranties, covenants and indemnification obligations of each party.
In addition, the terms of the Agreement provide Organon exclusive worldwide rights of first negotiation for specified potential future Daré products.
The foregoing description of the Agreement describes the terms material to Daré, does not purport to be complete and is qualified in its entirety by reference to the Agreement, a copy of which Daré intends to file with its quarterly report on Form 10-Q for the quarterly period ending March 31, 2022, with certain private or confidential provisions or terms redacted.
|Item 7.01||Regulation FD Disclosure.|
On March 31, 2022, Daré and Organon issued a joint press release announcing that they entered into the Agreement, a copy of which is attached as Exhibit 99.1 to this report and is incorporated herein by reference.
The information in Item 7.01 of this report, including Exhibit 99.1, shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to liability under that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”). The information contained in this Item 7.01 and in Exhibit 99.1 shall not be incorporated by reference into any filing with the Securities and Exchange Commission (the “SEC”) made by Daré, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Cautionary Statement Regarding Forward-Looking Statements
This report contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. To the extent that statements contained in this report are not descriptions of historical facts, they are forward-looking statements. Forward-looking statements include statements relating to the Agreement becoming effective, the development, manufacture and commercialization of XACIATO, the timing of the first commercial sale of XACIATO, and any future licensed product under the Agreement by Organon. Forward-looking statements are based on current expectations and assumptions that are subject to risks and uncertainties. Actual results could differ materially from those anticipated as a result of various factors, including, without limitation, the risks that the closing conditions in the Agreement may not be satisfied or waived and the Agreement may not become fully effective or may be terminated early; the risk that payments to Daré under the Agreement may be significantly less than anticipated or potential amounts; Daré’s dependence on Organon, its affiliates and/or its sublicensees to commercialize XACIATO and on other third parties to supply XACIATO and its components for commercial sale, and Daré’s lack of control over the efforts and resources that any of these third parties devotes to the manufacture and commercialization of XACIATO and any future licensed product. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in the forward-looking statements, as well as risks relating to Daré’s business in general, please refer to Daré’s annual report on Form 10-K filed with the SEC on March 31, 2022, and its current and future periodic reports filed with the SEC. You are urged to consider these factors carefully in evaluating the forward-looking statements in this report and are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. Unless otherwise required by law, Daré expressly disclaims any obligation to update publicly any forward-looking statements, whether as result of new information, future events or otherwise.
|Item 9.01||Financial Statements and Exhibits.|
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.
| || |
DARÉ BIOSCIENCE, INC.
|Dated: March 31, 2022|| || ||By:|| ||/s/ Sabrina Martucci Johnson|
| || ||Name:|| ||Sabrina Martucci Johnson|
| || ||Title:|| ||President and Chief Executive Officer|