UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM
(Amendment No. 1)
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CURRENT REPORT
Pursuant to Section 13 or 15(D)
of the Securities Exchange Act of 1934
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Explanatory Note
On June 26, 2024, Agile Therapeutics, Inc. (the “Company”) filed a Current Report on Form 8-K (the “Original 8-K”) with the Securities Exchange Commission, in which the Company reported, among other events, its entry into Amendment No. 3 (the “Amendment”) to that certain Manufacturing and Commercialization Agreement, dated April 30, 2020, by and between the Company and Corium, Inc. (“Corium”), as amended on July 25, 2022 and on May 15, 2024, which is designed to amend the Agreement to account for Insud’s current projected production requirements for Twirla and the associated cost of goods and is conditioned upon the consummation of the Merger, and will become effective at the Effective Time.
This Current Report on Form 8-K/A amends and supplements the Original 8-K filed by the Company, and is being filed solely to file certain exhibits to the Original 8-K. This amendment does not otherwise modify any other portions of the disclosure in the Original 8-K. Interested parties should refer to the Original 8-K, as supplemented by this Current Report on Form 8-K/A. Capitalized terms used herein but not otherwise defined have the meaning set forth in the Original 8-K. The foregoing description of the Amendment in this Current Report on Form 8-K/A and the Original 8-K does not purport to be complete and is qualified in its entirety by the full text of the Amendment which is filed as Exhibit 10.3 and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit |
| Description |
2.1 | ||
4.1 | ||
10.1 | ||
10.2 | ||
10.3* | ||
99.1 | ||
104 | Cover Page Interactive Data File (Embedded within the Inline XBRL Document). |
* Portions of this exhibit have been redacted in accordance with Regulation S-K Item 601(b)(10).
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Company has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Agile Therapeutics, Inc. | |
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Dated: July 16, 2024 | By: | /s/ Alfred Altomari |
| Name: | Alfred Altomari |
| Title: | Chairperson and Chief Executive Officer |
Information in this exhibit identified by [***] is confidential and has been excluded pursuant to Item 601(b)(10(iv) of Regulation S-K because it is both (i) not material and (ii) the type of information that the registrant customarily and actually treats and private and confidential.
Exhibit 10.3
CONDITIONAL AMENDMENT NO. 3 TO
MANUFACTURING AND COMMERCIALIZATION AGREEMENT
This Conditional Amendment No. 3 (“Amendment”) to the Agreement (as defined below) is made and entered into as of June 24, 2024 (“Amendment Effective Date”), by and between Corium Innovations, Inc., a Delaware corporation having its principal place of business at 4558 50th Street, S.E., Grand Rapids, MI 49512, including its Affiliates (“Corium”), Agile Therapeutics, Inc., a Delaware corporation, having its principal place of business at 500 College Rd. East, Suite 310 Princeton, NJ 08540, including its Affiliates (“Agile”), and Exeltis USA Inc., a New Jersey having its principle place of business at 180 Park Avenue, Suite 101, Florham Park, NJ, 07932 (“Exeltis”), in its capacity as the prospective purchaser of Agile (together, the “Parties”), and amends that certain Manufacturing and Commercialization Agreement, entered into as of April 30, 2020, by and between Corium and Agile (the “Original Agreement”), as amended by Amendment No. 1 entered into as of July 25, 2022 (“Amendment 1”) and Amendment No. 2 entered into as of May 13, 2024 (“Amendment 2”; the Original Agreement as amended by Amendment 1 and Amendment 2, the “Agreement”). All capitalized terms used herein and not otherwise defined herein shall have the meanings assigned to them in the Agreement.
WHEREAS, Agile engaged Corium to Manufacture and supply Product to Agile in accordance with the Agreement;
WHEREAS, Corium, Agile and its prospective purchaser, Exeltis, desire to amend the Agreement, in accordance with Section 12.1 of the Agreement, to account for Exeltis’s current projected production requirements for the Product and the associated cost of goods, amongst other matters;
WHEREAS, the Parties agree that this Amendment is conditional on the closing of the Acquisition (as defined below) and that the terms recited herein will only become binding and effective at the time of the closing of the Acquisition.
NOW, THEREFORE, THE PARTIES HERETO AGREE AS FOLLOWS:
[***] | $ [***] | ||
[***] | [***] | ||
[***] | [***] | ||
Subtotal | $ 5,062,998.84 | ||
(together, “the Outstanding Invoices”)
If the amounts set forth above for the Outstanding Invoices have not been paid in full by July 15, 2024, Corium shall be entitled to terminate this Amendment, and render it null, void, and of no force or effect, upon written notice to Agile and Exeltis. For clarity, notwithstanding anything to the contrary, and without limitation of the preceding portion of this Section 3, to the extent the amounts set forth in the Outstanding Invoices have not been paid before Closing, the balance thereof shall be paid by Agile upon Closing.
Part Number | Item | Qty | Total Cost |
[***] | [***] | [***] | [***] |
[Signature page to follow.]
IN WITNESS WHEREOF, the duly authorized representatives of the parties hereto have caused this Amendment to be duly executed.
Exeltis USA, Inc. | |
By: | /s/ Robert Spina |
Name: | Robert Spina |
Title: | President |
Date: | 6/25/24 |
Corium, Inc. | | Agile Therapeutics, Inc. | ||
By: | /s/ Mark Sirgo | | By: | /s/ Al Altomari |
Name: | Mark Sirgo | | Name: | Al Altomari |
Title: | President | | Title: | Chairperson and CEO |
Date: | 6/25/24 | | Date: | 6/25/24 |
ATTACHMENT 1
Exhibit A
Guaranteed Minimum Billed Revenue
[***]
ATTACHMENT 2
Exhibit B
Commercial Terms
[***]