UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date
of Report (Date of earliest event reported):
(Exact name of registrant as specified in its charter)
| (State
or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS
Employer Identification No.) |
| (Address of principal executive offices) | (Zip Code) |
Registrant’s
telephone number, including area code:
(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:
| 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 Exchange Act:
| Title of each class | Trading Symbol(s) |
Name of each exchange on which registered | ||
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 (the “Exchange Act”) (§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 December 12, 2023, Biofrontera Inc. (the “Company”) entered into an addendum (the “Addendum”) to its Amended and Restated License and Supply Agreement, dated as of June 16, 2021 (as amended on October 8, 2021, the “LSA”), by and among the Company, Biofrontera Pharma GmbH (“Pharma”), and Biofrontera Bioscience GmbH (“Bioscience”). The Addendum provides, among other things, for a schedule of payments in relation to various financial obligations among the Company, Pharma, Bioscience, and Biofrontera AG (the parent company of Pharma and Bioscience), including updated terms relating to payments by the Company to Pharma for purchases of Licensed Products (as that term is defined in the LSA) under the LSA through the end of 2024.
This description of the Addendum does not purport to be complete and is qualified in its entirety by reference to the full text of the
Addendum, a copy of which is attached as Exhibit 10.1 to this Current Report on Form 8-K and incorporated herein by reference.
| Item 9.01 | Financial Statements and Exhibits. |
| 10.1 | Addendum to Amended and Restated License and Supply Agreement, dated as of December 12, 2023 |
| 104 | Cover Page Interactive Data File (the cover page XBRL tags are embedded within the inline XBRL document) |
SIGNATURE
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.
December 15, 2023 (Date) |
Biofrontera Inc. (Registrant) |
/s/ E. Fred Leffler III | |
| E. Fred Leffler III | |
| Chief Financial Officer |
Exhibit 10.1
Addendum to Amended and Restated License and Supply Agreement
This Addendum to Amended and Restated License and Supply Agreement (the “Addendum”) is made effective as of December 5, 2023, by and between Biofrontera AG (“AG”), Biofrontera Pharma GmbH (“PHARMA”), and Biofrontera Bioscience GmbH (“BIOSCIENCE”), each a German corporation/company with its principal offices at Hemmelrather Weg 201, 51377 Leverkusen, Germany, and Biofrontera Inc., a Delaware corporation with its principal place of business at 120 Presidential Way, Woburn, MA 01801, USA (“INC”). AG, PHARMA, BIOSCIENCE, and INC may collectively be referred to as the “Parties” or individually as a “Party.” Capitalized terms used but not defined herein shall have the meanings assigned to them in the Agreement, as defined below.
Recitals
Whereas, PHARMA, BIOSCIENCE, and INC have entered into an Amended and Restated License and Supply Agreement, dated as of June 16, 2021, as amended by that certain Corrected Amendment to Amended and Restated License and Supply Agreement, dated as of October 8, 2021(collectively, the “Agreement”);
Whereas, the Parties wish to add additional terms to the Agreement in regard to certain mutual payment obligations between the Parties, as described below; and
Now, therefore, in consideration of the foregoing and the agreements contained herein, the Parties hereto, intending to be legally bound hereby, agree as follows:
Agreement
| 1. | Payment Obligations. This Addendum pertains to the payment of the following obligations of each of the Parties (collectively, the “Payment Obligations”): |
| a. | INC’s payment of Invoice No. DARM00429 to PHARMA; | |
| b. | INC’s payment of Invoice No. AR01207 (as adjusted to reflect termination of IT services on December 19, 2022) to PHARMA; | |
| c. | INC’s payment of Invoices No DARM0043, DARM00444, DARM00484 to PHARMA; | |
| d. | INC’s payment of invoices No TAR01584 and No.TAR01593 (services issues) to BIOSCIENCE; | |
| e. | BIOSCIENCE’s payment of Invoice Nos. BioSci 2023-Q3, BioSci 2023-10, and BioSci 2023-09 to INC; | |
| f. | INC’s payment of an invoice to be issued by PHARMA in relation to PO #11440 (for the purchase of Ameluz); | |
| g. | AG’s reimbursement of its 50% share of the “Third Installment” payment under a certain “Amended Settlement Allocation Agreement” between INC and AG dated March 31, 2023 to INC; | |
| h. | INC’s payment of the purchase price variance as described in Section 6.5 of the Agreement for the year ending December 31, 2023 (“2023 PPV”) to PHARMA; |
| 1 |
| i. | INC’s payments of invoices to be issued by PHARMA in relation to POs #11272, #11305, and #11154; and | |
| j. | BIOSCIENCE’s payment of invoices to be issued by INC in relation to clinical services provided to BIOSCIENCE in Q4 2023. |
| 2. | Payment Schedule. To satisfy the Payment Obligations in full, the Parties agree to the following payment schedule (collectively, the “Payment Schedule”): |
| a. | On or before December 20, 2023, INC will pay to PHARMA $2.791M towards DARM0043, DARM00444, DARM00484 and DARM00429. |
| i. | This sum shall be reduced by any outstanding payments from BIOSCIENCE to INC under Invoice Nos. BioSci 2023-Q3, BioSci 2023-10, and BioSci 2023-09 (currently, approximately $137K). |
| b. | On or before January 31, 2024, INC will pay to PHARMA i) the remainder owed under DARM00429 (approximately $1.4-l.6M), and ii) the full amount owed under the invoice to be issued by PHARMA in relation to PO# 11440 (estimated at approximately $2.9M). |
| i. | This sum shall be reduced by any outstanding reimbursement from AG to INC for AG’s 50% share of the “Third Installment” payment under the “Amended Settlement Allocation Agreement” between INC and AG dated March 31, 2023 (currently, $2.815M) and any outstanding payments from BIOSCIENCE to INC in relation to clinical services provided to BIOSCIENCE in Q4 2023. |
| c. | On or before January 31, 2024, INC will pay to AG invoice AR01207 and to Bioscience invoices No TAR01584 and No.TAR01593. |
| d. | On or before April 30, 2024, INC will pay to PHARMA the agreed upon 2023 PPV and any invoices issued by PHARMA in relation to POs #11272, #11305, and #11154. |
| i. | These payments shall be contingent on INC and PHARMA’s agreement on the 2023 PPV and PHARMA’s timely delivery of the products described in POs #11272, #11305, and #11154. |
| e. | For all remaining purchases of “Licensed Products” (as defined by the Agreement) by INC in 2024, INC shall make payment to PHARMA within the standard payment term described in Section 6.1 of the Agreement. However, if INCfails to make payment in accordance with Section 6.1 of the Agreement for any reason, INC shall pay the overdue amount to PHARMA within thirty {30) additional days, in addition to interest calculated in accordance with Section 4.l(d) ofthe Agreement. |
| For purposes of clarification, for all remaining purchases of Licensed Products by INC in 2024, INC shall not have any rights to any cure period provided in Section 16.3 other than as set forth in this paragraph 2(d). |
| 2 |
| 3. | Other Terms. |
| a. | The Parties agree that INC’s timely completion of payments described in the Payment Schedule will effectively satisfy the Payment Obligations, in full. As such, so long as INC makes timely payments under the Payment Schedule, AG shall have no | |
| grounds to invoke the provisions of Section 16.3 of the Agreement or otherwise consider INC to be in breach ofthe Agreement due to non-payment of any Payment Obligations. | ||
| Notwithstanding the foregoing, any failure by INC to timely make any payments for “Licensed Products” as defined by the Agreement under the Payment Schedule shall constitute a material breach pursuant to the Agreement and shall entitle AG to enforce any rights under the Agreement, including any rights of termination pursuant to Section 16.3 of the Agreement, immediately upon such failure by INC to make timely payment as defined by Section 2 of this Addendum, irrespective of any cure period provided in Section 16.3 of the Agreement. |
| b. | This Addendum shall only serve to supplement, amend, and/or modify the Agreement to the extent specifically provided herein. All terms, conditions, provisions, exhibits and references of and to the Agreement that are not specifically supplemented, amended, and/or modified herein shall remain in full force and effect and shall not be altered by any provisions herein contained. |
IN WITNESS WHEREOF, the Parties have executed this Addendum to Amended and Restated License and Supply Agreement as of the date first set forth above.
| BIOFRONTERA AG | BIOFRONTERA INC. | |||
| BIOFRONTERA PHARMA GmbH | ||||
By: |
/s/ Pilar De La Huerta |
By: |
/s/ Hermann Luebbert | |
| Name: | Pilar De La Huerta | Name: | Hermann Luebbert | |
| Title: | Chief Financial Officer - Biofrontera AG |
Title: | Chief Executive Officer | |
| Managing Director - Biofrontera Pharma GmbH | ||||
| Managing Director - Biofrontera Bioscience GmbH | ||||
| Date: | 12/12/2023 | Date: | 12/12/2023 | |
| 3 |