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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
PURSUANT
TO SECTION 13 OR 15(D)
OF
THE SECURITIES EXCHANGE ACT OF 1934
Date
of Report (Date of earliest event reported): February
13, 2024
Biofrontera
Inc.
(Exact
name of registrant as specified in its charter)
Delaware |
|
001-40943 |
|
47-3765675 |
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File
Number) |
|
(IRS
Employer
Identification
No.) |
120
Presidential Way, Suite 330
Woburn,
Massachusetts |
|
01801 |
(Address
of principal executive offices) |
|
(Zip
Code) |
Registrant’s
telephone number, including area code: (781) 245-1325
Not
Applicable
(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 |
Common
stock, par value $0.001 per share |
|
BFRI |
|
The
Nasdaq Stock Market LLC |
Preferred
Stock Purchase Rights |
|
|
|
The
Nasdaq Stock Market LLC |
Warrants
to purchase common stock |
|
BFRIW |
|
The
Nasdaq Stock Market LLC |
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. |
LSA Amendment
On
February 19, 2024, Biofrontera Inc. (the “Company”) entered into the Second Amended and Restated License and
Supply Agreement (the “LSA”), effective as of February 13, 2024 , by and among the Company, Biofrontera Pharma
GmbH (“Pharma”), and Biofrontera Bioscience GmbH (“Bioscience”). The LSA amends and restates the
license and supply agreement, originally dated as of October 1, 2016, between the Company, Pharma and Bioscience and which was previously
amended on July 1, 2019, June 16, 2021, October 8, 2021, December 5, 2023 and January 26, 2024.
Among
other things, the LSA has been amended to (i) change the Transfer Price (as defined in the LSA) to 25% through 2025 and then increasing
over time pursuant to the schedule set forth in the LSA to a maximum of 35% starting in 2032, subject to a minimum dollar amount per
unit, from the previous Transfer Price of 50% of annual revenue up to $30 million, and then decreasing
on further sales until reaching 30% of annual revenue at and above $50 million, (ii)
provide for the transfer of responsibilities for Ongoing Trials (as defined in the LSA) on or before June 1, 2024, including the Company
assuming related contracts and transferring key personnel from Pharma and Bioscience to the Company, and (iii) make the failure to achieve
the applicable Annual Minimum Sales (as defined in the LSA) a termination event in certain circumstances, unless waived by Pharm and
Bioscience. The LSA also includes an Addendum to the LSA which modifies 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 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.
In connection with the LSA,
the Company entered into a Release of Claims (the “Release”), dated February 13, 2024, between the Company,
Pharma and Bioscience, pursuant to which the Company agreed to release Pharma and Bioscience from all claims and liabilities arising
out of or relating to any failure by Pharma and Bioscience to perform certain obligations under the LSA with respect to clinical trials
that the Company will assume responsibility for under the LSA.
This
description of the LSA and the Release does
not purport to be complete and is qualified in its entirety by reference to the full text of the LSA and
the Release, as applicable, copies of which are
attached as Exhibits
10.1 and
10.2, respectively, to this Current Report on
Form 8-K and incorporated herein by reference.
Item 7.01 |
Regulation
FD Disclosure |
On
February 20, 2024, the Company issued a press release announcing the amendment to the LSA, a copy of which is attached hereto as Exhibit
99.1.
The
information in Item 7.01 of this Current Report is being furnished and shall not be deemed “filed” for the purpose of Section
18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. The information in Item
7.01 of this Current Report shall not be incorporated by reference into any registration statement or other document pursuant to the
Securities Act of 1933, as amended.
On
February 20, 2024, the Company announced that it has entered into securities purchase agreements with healthcare-focused
institutional investors led by Rosalind Advisors, Inc. Pursuant to the securities purchase agreements, the Company will issue
to the purchasers (a) an aggregate $6.6 million in shares of a newly created Series B-1 Convertible Preferred Stock (the
“Series B-1 Preferred”) and (b) an aggregate $1.4 million in warrants to purchase shares of the Company’s Series
B-3 Convertible Preferred Stock (the “Series B-3 Preferred”) with an aggregate exercise price of $8 million (the
“Warrants”). The Warrants will be exercisable until the earlier of (i) 5 days following the date of completion of (A)
the Company’s public announcement of (I) at least 95% of the Company’s territory managers, medical science liaisons, and
reimbursement employees are using the Company’s newly implemented customer relationship management system routinely or on a
performance improvement plan and (II) the Company’s revenue for the period starting on January 1, 2024 and ending no earlier
than April 30, 2024 excluding revenue from related parties (including Biofrontera AG) is at least 5% higher than the Company’s
revenue excluding revenue from related parties (including Biofrontera AG) for the corresponding period of the same length, starting
on January 1, 2023, for which an announcement shall be made promptly after certification by the Company’s board of directors
that such targets have been completed, and (B) the approval by the Company’s stockholders of certain proposals related to the
private placement, and (C) the effectiveness of a registration statement with the U.S. Securities and Exchange Commission covering
the resale of the common stock underlying all shares of Series B-3 Preferred Stock (as defined below) and (ii) the five-year
anniversary of the issuance of the warrants.
Shares
of Series B-1 Preferred Stock and Series B-3 Preferred Stock, upon exercise of the warrants, will be issued at a price of $1,000.00
per share. Holders of any Series B-1 or B-3 Preferred Stock may not convert their shares into common shares if, after giving effect
to such conversion, such holder would beneficially own more than 9.9% of the then-outstanding Common Stock. Conversion of all of the
shares of Series B-3 Convertible Preferred Stock into shares of common stock of the Company is subject to approval by the
Company’s stockholders of an increase in the Company’s authorized shares of common stock. The shares of Series B-1
Preferred Stock convert into 9,310,677 shares of common stock at a conversion price of $0.7074. The shares of Series B -3
Convertible Preferred Stock to be issued upon exercise of all of the warrants convert into 11,309,019 shares of common stock
(disregarding any conversion or beneficial ownership limitations) at a conversion price of $0.7074. The consideration for each
warrant is $0.125 per share of common stock that each share of Series B-3 Convertible Preferred Stock may be converted
into.
Biofrontera
anticipates that aggregate gross proceeds will be up to $16 million, if all warrants are exercised, before deducting fees to the placement agents and other estimated
offering expenses payable by the Company. This private placement is expected to close on or about February 21, 2024, subject to customary
closing conditions.
The
Company agreed to appoint up to two directors nominated by Rosalind Advisors to the board of directors of the Company. The Company also agreed to file a registration statement providing for the resale of the common stock issuable upon
the conversion of the Series B-1 Preferred and the Series B-3 Preferred.
The
Company intends to use the upfront net proceeds from the private placement to fund the Company’s general business operations and
ongoing activities related to expediting the development and approval of additional indications for the Company’s lead product
Ameluz. The product is currently approved in conjunction with the BF-RhodoLED lamp series for the treatment of mild to moderate actinic
keratosis on the face and scalp (AK).
The
securities to be issued in connection with the private placement described above are being offered in a private placement under Section
4(a)(2) of the Securities Act of 1933 and Regulation D promulgated thereunder and have not been registered under the Act or applicable
state securities laws. Accordingly, such securities may not be offered or sold in the United States except pursuant to an effective registration
statement or an applicable exemption from the registration requirements of the Securities Act of 1933 and such applicable state securities
laws. The Company has agreed to file a resale registration statement with the U.S. Securities and Exchange Commission, for purposes of
registering the resale of the common stock issued or issuable in connection with the private placement.
A
copy of the press release announcing the private placement is attached hereto as Exhibit 99.2. Neither the press release not this Form
8-K shall constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor shall there be
any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to
the registration or qualification under the securities laws of any such state or other jurisdiction.
Item
9.01 |
Financial
Statements and Exhibits. |
10.1 |
Second
Amended and Restated License and Supply Agreement, dated February 19, 2024, between the Company, Pharma and Bioscience. |
10.2 |
Release of Claims, dated February
13, 2024, between the Company, Pharma and Bioscience. |
99.1 |
Press release with respect to the amendment to the LSA, dated February 20, 2024 |
99.2 |
Press release announcing the Offering, dated February 20, 2024 |
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.
February
20, 2024
(Date) |
|
Biofrontera
Inc.
(Registrant) |
|
|
|
|
By: |
/s/
E. Fred Leffler III |
|
|
E.
Fred Leffler III |
|
|
Chief
Financial Officer |
Exhibit
10.1
Second
Amended and Restated License and Supply Agreement
This
Second Amended and Restated License and Supply Agreement (the “Amendment”) is made effective as of February 13, 2024,
by and between Biofrontera Pharma GmbH, a German corporation with its principal offices at Hemmelrather Weg 201, 51377 Leverkusen, Germany
(“PHARMA”), Biofrontera Bioscience GmbH, a German corporation with its principal offices at Hemmelrather Weg 201, 51377 Leverkusen,
Germany (“BIOSCIENCE”) and Biofrontera Inc., a Delaware corporation with its principal place of business at 120 Presidential
Way, Suite 330, Woburn, MA 01801, USA (“INC”). PHARMA and INC may collectively be referred to as the “Original Parties.”
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 LSA (as hereafter defined).
Amendment
Recitals
Whereas,
the Parties have entered into a License and Supply Agreement, dated as of October 1, 2016, which was amended as of i) July 01, 2019 (with
said amendment erroneously referring to the LSA’s effective date as July 15, 2016), ii) June 16, 2021, iii) October 8, 2021 (with
said amendment correcting a previous version signed on the amendment’s effective date), iv) December 5, 2023, and v) January 26,
2024 (collectively, the “LSA”);
Whereas,
the Parties wish to amend certain aspects of the LSA and restate the LSA in its entirety.
Now,
therefore, in consideration of the foregoing and the agreements contained here, the Parties hereto, intending to be legally bound hereby
agree as follows:
Amended
Agreement
RECITALS
(A) | PHARMA
and BIOSCIENCE are subsidiaries of Biofrontera AG, Hemmelrather Weg 201, 51377 Leverkusen,
Germany. The Biofrontera group currently consists of Biofrontera AG and its subsidiaries
PHARMA, BIOSCIENCE, Biofrontera Development GmbH and Biofrontera Neuroscience GmbH, located
at Hemmelrather Weg 201, 51377 Leverkusen, Germany. The group is specializing in the development
and marketing of drugs for the care and treatment of dermatological and inflammatory diseases.
BIOSCIENCE is, within Biofrontera group, responsible for drug development and registration,
and is the holder of the group’s medicinal product approvals. PHARMA is responsible
for manufacturing, marketing, and sales as well as licensing of the products to Third Parties
(as hereafter defined). |
(B) | One
of PHARMA’s key projects is the manufacturing and sales of pharmaceutical formulations
with BF-200 ALA, containing the active ingredient 5-aminolevulinic acid (the “Substance”)
in soluble BF-200 nano-vesicles, and of the PDT lamp BF-RhodoLED®. BF-200 ALA drug product
is already being commercialized in various countries in Europe as a gel under PHARMA’s
trademark AMELUZ® in units, i.e. tubes, each containing two (2) grams, and is hereinafter
referred to as the “Product”. The Product is dedicated to be used for the photodynamic
treatment of actinic keratosis/non-melanoma skin cancer (the “Field”). Photodynamic
treatment requires a light illumination, for which BF-RhodoLED® is designed. The approval
granted by the U.S. Food and Drug Administration (“FDA”) covers the lesion- and
field-directed treatment of mild to moderate actinic keratosis on the face and scalp using
the combination of Ameluz® with the lamp BF-RhodoLED® (the “Lamp”). For
the avoidance of doubt, the term “Lamp” shall be construed to apply to all current
and future iterations of the BF-RhodoLED®, including but not limited to the “BF-RhodoLED
XL”. |
(C) | Both,
patents and trademarks to Product and Lamp, each as listed in Exhibit Recital (C), are owned
by PHARMA or by BIOSCIENCE and exclusively licensed, with the right to grant sublicenses,
to PHARMA with the purpose of sales and marketing and/or further out licensing to Third Parties.
The patents listed in Recital (C) are hereinafter referred to as the “PHARMA Patent
Rights”, and the trademarks listed in Recital (C) are hereinafter referred to as the
“PHARMA Trademark Rights”. BIOSCIENCE has obtained a centralized European approval
for marketing the Product in the European Union under the trademark AMELUZ®, the rights
to which are part of the PHARMA Trademark Rights. It has further received an approval by
the U.S. Food and Drug Administration for marketing the product in the United States of America
under the same trademark and in combination with the PDT-lamp BF-RhodoLED®. |
(D) | INC
is a pharmaceutical company well established in the United States of America and is dedicated
to, among other things, the commercialization of innovative ethical pharmaceuticals and medical
devices. |
(E) | INC
is interested in taking out an exclusive license from PHARMA and BIOSCIENCE to make use of
the aforementioned Patents and Trademarks, and to market and sell Product and Lamp in the
U.S. after purchasing from PHARMA the Product and the Lamp, and PHARMA and BIOSCIENCE are
prepared, subject to the terms and conditions of this Agreement, to both grant INC such a
license and to supply INC with the Product and the Lamp. |
NOW,
THEREFORE, THE PARTIES AGREE AS FOLLOWS
For
purposes of this Agreement, the following capitalized terms shall have the following meanings:
| 1.1. | “Agreement”
shall mean this Agreement and all Exhibits attached hereto, and the terms “herein”,
“hereunder”, “hereto” and such similar expressions shall refer to
this Agreement. |
| 1.2. | “Breaching
Party” shall have the meaning as set forth in Section 16.3. |
| 1.3. | “PHARMA
IP” shall mean the PHARMA Patent Rights and the PHARMA Trademark Rights. |
| 1.4. | “PHARMA
Know-How” shall mean (i) all Information which is Controlled by PHARMA or its Affiliates
as of the Effective Date or which becomes Controlled by PHARMA or its Affiliates at any time
during the Term and (ii) which is reasonably necessary for INC to exploit the License. Notwithstanding
anything herein to the contrary, PHARMA Know How excludes published PHARMA Patents. |
| 1.5. | “PHARMA
Technology” shall mean the PHARMA Patent Rights, PHARMA Trademarks and the PHARMA
Know-How. |
| 1.6. | “PHARMA
Patent Rights” shall have the meaning as set forth in Recital (C). |
| 1.7. | “PHARMA
Trademark Rights” shall have the meaning as set forth in Recital (C), and ‘‘PHARMA
Trademark(s)” shall mean any trademark covered by the PHARMA Trademark Rights. |
| 1.8. | “Change
of Control” shall mean with respect to a Party, any of the following events occurring
after the Effective Date: (i) any Third Party, together with its Affiliates directly or indirectly
is or becomes the record or beneficial owner (provided that a person shall be deemed to have
“beneficial ownership” of all shares that any such person has the right to acquire,
whether such right is exercisable immediately or only after the passage of time), whether
in one or a series of transactions, of fifty percent (50%) or more of the total voting power
of all classes of capital stock then outstanding of such Party exercisable at any meeting
of the shareholders of that Party; (ii) such Party consolidates with or merges into another
corporation or entity, or any corporation or entity consolidates with or merges into such
Party, in either event pursuant to a transaction in which fifty percent (50%) or more of
the total voting power of all classes of capital stock then outstanding of such Party exercisable
at any meeting of shareholders of that Party is acquired by any Third Party or its Affiliates;
(iii) such Party sells all or substantially all of its assets to any Third Party; or (iv)
any Third Party has the right to control the supervisory board and/or the executive board
of directors or equivalent governing body of such Party or the ability to cause the direction
of the management or policies of such Party. |
| 1.9. | “Claims
and Liabilities” shall have the meaning as set forth in Section 15.1. |
| 1.10. | “Commercial
Year” is any calendar year, starting on the first full calendar year after the
date of the First Commercial Sale. |
| 1.11. | “Confidential
Information” shall mean and include any scientific, technical, trade or business information
possessed, obtained by, developed for or given to the Disclosing Party which is treated by
the Disclosing Party as confidential or proprietary including research materials, formulations,
techniques, methodology, assay systems, formulae, procedures, tests, equipment, data, reports,
know how, any information relevant to obtain and/or maintain Regulatory Approval, sources
of supply, patent positioning, relationships with consultants and employees, business plans
and business developments, information concerning the existence, scope or activities of any
research, development, manufacturing, marketing or other projects of the Disclosing Party,
and any other confidential information about or belonging to the Disclosing Party’
s suppliers, licensors, licensees, partners, affiliates, customers, potential customers or
others, that the Disclosing Party is authorized to disclose under a confidentiality agreement. |
| 1.12. | “Control”
or “Controlled” shall mean with respect to any (i) item of information, including,
without limitation, know-how, or (ii) intellectual property right, the possession (whether
by ownership or license, other than pursuant to this Agreement) by a Party of the ability
to grant to the other Party access or a license as provided herein under such item or right
without violating the terms of any agreement or other arrangements with any Third Party. |
| 1.13. | “Disclosing
Party” shall have the meaning set forth in Section 13.2 hereof. |
| 1.14. | “Effective
Date” of this Agreement shall mean the date on which this Agreement is executed by
the duly authorized representatives of each of the Parties hereto. If the Agreement is not
executed by both Parties on the same day, the later date shall be the “Effective Date”. |
| 1.15. | “Field”
shall have the meaning of non-melanoma skin cancer or any other disease of the skin that
will be treated by Photodynamic Therapy with Ameluz® or a similar product
combining 5-aminolevulinic acid with a nanoemulsion and a red-light lamp or any other source
of light. |
| 1.16. | “First
Commercial Sale” shall mean with respect to any Licensed Product in the Territory,
the first sale by INC or its Affiliates of any of the Licensed Products for use in the Field. |
| 1.17. | “Improvement(s)”
shall mean and include any and all Inventions, and any and all changes, modifications and
amendments to the PHARMA Technology, which: (i) improve the performance, sensitivity and/or
specificity of the Licensed Products and/or the Lamp; (ii) reduce any side effects or other
adverse effects of the Licensed Products and/or the Lamp; or (iii) reduce the cost and/or
increase the efficiency or productivity of the manufacturing and production processes for
the Licensed Products and/or the Lamp. |
| 1.18. | “Information”
shall mean information and materials relating to the subject matter of this Agreement and
including (i) techniques and data, including, but not limited to, screens, models, inventions,
methods, test data, including but not limited to, biological, chemical, pharmacological,
biochemical, pharmaceutical, toxicological, safety, preclinical and clinical test data, physical
and analytical and quality control data, marketing, pricing, distribution, costs, sales data,
manufacturing information, and patent and legal data or descriptions (to the extent that
disclosure thereof would not result in loss or waiver of privilege or similar protection),
(ii) discoveries, trade secrets, specifications, instructions, improvements, processes, formulae,
expertise and other technology, (iii) compositions of matter, including but not limited to
compounds, biological materials and assays and (iv) regulatory filings, including the eCTD
or marketing approval application (MAA). As used herein, “clinical test data”
shall be deemed to include all information related to the clinical or preclinical testing
of the Substance, a Product, a Licensed Product and/or the Lamp, including without limitation,
patient report forms, investigators’ reports, bio statistical, pharma-economic and
other related analyses, and the like. |
| 1.19. | “Invention(s)”
shall mean and include any and all inventions and discoveries which are, or may be, patentable
or otherwise protectable under the patent or other intellectual property laws of any country,
which relate to Licensed Products and/or the Lamp, and which are conceived, discovered or
reduced to practice during the Term. |
| 1.20. | “Lamp”
shall have the meaning as set forth in Recital (B). |
| 1.21. | “License”
shall have the meaning as set forth in Section 2.1. |
| 1.22. | “Licensed
Product” shall mean any Product, the use of which by INC, as of the Effective Date,
is covered by any claim of any of the PHARMA Patent Rights and/or any of the PHARMA Know-How. |
| 1.23. | “Net
Sales” means, with respect to a given period of time, gross sales of Licensed Product
in such period in any good faith transaction on an at-arm’s-length basis, less the
following Deductions which are actually incurred, allowed or paid: |
| a. | credits
or allowances actually granted for damaged Licensed Product, returns or rejections of Licensed
Product, price adjustments and billing errors; |
| b. | governmental
and other rebates (or equivalents thereof) granted to managed health care organizations;
pharmacy benefit managers (or equivalents thereof); federal, state/provincial, local and
other governments, their agencies and purchasers and reimbursers; or to trade customers; |
| c. | normal
and customary trade, cash and quantity discounts, allowances and credits; |
| d. | sales
taxes, value added taxes and other taxes applied to the sale of Licensed Product to the extent
included in the gross amount invoiced; and |
| e. | Sales
of Licensed Product between or among INC and its Affiliates shall be excluded from the computation
of Net Sales, but the subsequent final sales of Licensed Product to Third Parties by such
Affiliates shall be included in the computation of Net Sales. |
| 1.24. | “Non-Breaching
Party” shall have the meaning as set forth in Section 16.3. |
| 1.25. | “Party”
or “Parties” shall mean INC or PHARMA, or INC and PHARMA, as the context admits. |
| 1.26. | “Patent(s)”
or “Patent Right(s)” shall mean any and all (i) patents, (ii) pending patent
applications, including, without limitation, all provisional applications, substitutions,
continuations, continuations-in-part, divisions, renewals, and all patents granted thereon,
(iii) all patents-of-addition, reissues, reexaminations and extensions or restorations by
existing or future extension or restoration mechanisms, including, without limitation, supplementary
protection certificates or the equivalent thereof, (iv) inventor’s certificates, (v)
any other form of government-issued right substantially similar to any of the foregoing;
and (vi) all German and other foreign counterparts of any of the foregoing. |
| 1.27. | “Product”
shall have the meaning as set forth in Recital (B) hereof or any other product combining
5-aminolevulinic acid with a nanoemulsion. |
| 1.28. | “Receiving
Party” shall have the meaning set forth in Section 13.2 hereof. |
| 1.29. | “Regulatory
Approvals” shall mean and include all licenses, permits, authorizations and approvals
(including e.g. CE certificates) of, and all registrations, filings and other notifications
to, any Regulatory Authority within the Territory, necessary for the manufacture, production,
distribution, marketing, sale and/or use of the Licensed Products and/or the Lamp within
the Field and in a particular country or region of the Territory. |
| 1.30. | “Regulatory
Authorities” shall mean any national, supra-national, regional, state or local regulatory
agency, department, bureau, commission, council or other governmental entity in each country
of the world involved in the granting of Regulatory Approval for the Licensed Products and/or
the Lamp. |
| 1.31. | “Substance”
shall have the meaning as set forth in Recital (B) hereof. |
| 1.32. | “Term”
shall have the meaning as set forth in Section 16.1. |
| 1.33. | “Territory”
shall mean the United States of America including American Samoa, Guam and the U.S. Virgin
Islands. |
| 1.34. | “Third
Part(y/ies)” shall mean any party other than INC and PHARMA that is neither an Affiliate
of INC nor of PHARMA. |
| 1.35. | “Transfer
Price” shall have the meaning as set forth in Section 6.2 hereof. |
2. | GRANT
AND SCOPE OF LICENSE. |
License.
Pharma and BIOSCIENCE hereby grant to INC, and INC hereby accepts, as of the Effective Date, an exclusive, non-transferable license
to the PHARMA Technology to use, import, export, distribute, market, offer for sale and sell the Licensed Product and the Lamp in
the Territory and in the Field, in each case for commercializing the Licensed Product and the Lamp with the right and obligation to use
only the PHARMA Trademarks AMELUZ® and BF-RhodoLED®, in accordance with the terms and conditions of this Agreement (the “License”).
INC may use third party distributors or service providers to exploit the license if and when commercially reasonable and with the prior
written agreement by PHARMA and BIOSCIENCE. INC may, in its reasonable discretion, grant a sub-license under this Agreement if it believes
doing so is necessary in order to maximize this Agreement’s value to the Parties. PHARMA and BIOSCIENCE will, following the Effective
Date, provide INC access to the PHARMA Know-How for INC to make use of the License, and in particular will share all Information and
Know-How reasonably required to obtain registration, reimbursement and subsequently market the Product in the Territory. For the avoidance
of doubt, this grant of the License shall effectively enable INC to continue to operate as a legal entity named “Biofrontera Inc”
during the effective life of this Agreement.
2.1. | Use
and Protection of Trademarks |
| a. | During
the Term, PHARMA will maintain and, if necessary, procure renewal of the PHARMA Trademarks
with respect to the Licensed Product and the Lamp, respectively, in the Territory. Unless
expressly authorized by PHARMA in writing, INC will not use any of the PHARMA Trademarks
listed in Exhibit Recital (C) in any form other than agreed upon with PHARMA. If, during
the Term, PHARMA modifies the style of any of the PHARMA Trademarks, INC will be notified
without undue delay. In that case, INC will take reasonable measures to adapt its specific
way of use of the respective PHARMA Trademark(s) to the new style introduced by PHARMA. |
| b. | In
order to safeguard PHARMA’ s rights and interests concerning proper use of the PHARMA
Trademarks in accordance with Section 2.1a above, INC agrees to comply with branding guidance
developed by PHARMA and to provide to PHARMA for its review copies of any advertising materials,
websites and any other items, materials and media showing any of the Trademarks, where possible
in advance of introduction of the respective materials into the market. INC shall always
combine the PHARMA Trademarks with the registration symbol ®. On advertising materials,
INC shall, in addition, refer to PHARMA’ s ownership by using the marking legend “…
is a registered trademark of . . .” or in some other form as PHARMA may reasonably
require from time to time. |
| c. | INC
recognizes PHARMA’ s title to the Trademarks and shall not at any time impair PHARMA’
s rights to any of the PHARMA Trademarks. All uses of the PHARMA Trademarks by INC shall
inure to the benefit of PHARMA. INC hereby assigns and transfers to PHARMA any and all trademark
rights which may be created by its use of the PHARMA Trademarks. |
| 3.1. | Commercially
Reasonable Efforts. INC shall use its commercially reasonable efforts and resources to |
| i. | obtain
an individual HCPCS code and reimbursement price for the Licensed Product from the Relevant
Authorities in the Territory. |
| ii. | exploit
the License and thus to market the Licensed Product and the Lamp. |
| iii. | provide
the service and maintenance for the Lamp to customers as instructed and trained by PHARMA. |
The
standard of such commercially reasonable efforts and resources shall in each case be the efforts and resources that INC would, in accordance
with industry standards and practice for a company of comparable size and capability and active in the same business area, use in promoting,
detailing and marketing its own pharmaceutical products that are of comparable market potential as the Licensed Product, taking into
account product labeling or anticipated labeling, present and future market potential, past performance (if any), economic return potential,
medical and clinical considerations, the present and future regulatory environment (including pricing and reimbursement) and competitive
market conditions in the Field, all as measured by the facts and circumstances at the time such efforts are due, but without taking into
account any payment obligations to PHARMA under this Agreement. If reimbursement in the Territory is required for commercial success,
such commercially reasonable efforts shall include, but not be limited to, for INC to use its commercially reasonable efforts and resources
to obtain favorable decisions of the responsible authorities in the Territory about the reimbursement of the Product where such reimbursement
is desirable.
| 3.2. | Anticipated
Sales. [Reserved] |
| 3.3. | Minimum
Sales – Ameluz®. Starting in 2025 and then continuing for the remainder of
the Term, INC agrees to purchase the higher of a minimum quantity of [***] tubes of
Ameluz® per year or at least [***]% of the annual average of audited Ameluz®
tubes sold during the preceding four (4) full calendar years (the “Annual Minimum
Sales”). The Annual Minimal Sales shall not apply in the event that INC provides
reasonable detail to PHARMA that the market is affected by unforeseeable material changes
beyond the reasonable control of INC (including but not limited to i) PHARMA’s inability
to deliver quantities of Ameluz® ordered by INC, ii) significant regulatory changes (i.e.,
inclusion of a “black box warning” in the FDA approved Ameluz® labeling or
similar occurrence), iii) relevant market change caused by either the approval
or availability to the public in the Territory of a generic version of a PDT
drug to treat AK, or iv) the imposition of a significant reduction of Ameluz® or PDT
reimbursement by a US governmental entity or private payer). In all other cases, if INC fails
to achieve the respective Annual Minimum Sales for any calendar year during the Term, such
failure will constitute a termination event according to Section 16.3 unless PHARMA and BIOSCIENCE
determine, in their sole discretion, to waive the Annual Minimum Sales requirements or the
Parties enter into an amendment to the Annual Minimum Sales. |
| 3.4. | Non-fulfillment.
If PHARMA reasonably believes that INC is not using commercially reasonable efforts with
respect to the commercialization of the Licensed Products, then PHARMA may provide to INC
written notice specifying in reasonable detail the reasons for such assertion. Upon receipt
of such notice, INC shall have a period of thirty (30) days to provide to PHARMA, by written
notification, evidence that INC has been using commercially reasonable efforts with respect
to the commercialization of Licensed Products, or a period of three (3) months to cure the
lack of diligence based on the reasons submitted by PHARMA (“Evidence and Cure Period”).
If INC presents evidence reasonably acceptable to PHARMA that INC has used commercially reasonable
efforts with respect to the commercialization of the Licensed Products, or if the lack of
diligence has been cured by INC, then PHARMA’s notice shall be deemed withdrawn and
of no effect. If, within such periods, INC has not presented evidence reasonably acceptable
to PHARMA and has not cured such lack of diligence within such period, this will constitute
a termination event according to Section 16.3. |
| 3.5. | Covenant
not to Compete. INC shall not, directly or indirectly, in any country of the Territory,
market and/or sell any product in the area of the indications for which the Licensed Product
is registered without the prior written consent of Pharma. |
| 3.6. | Reporting
and Forecasting. |
| a. | Following
the Effective Date, until Reimbursement status and HCPCS codes for the Licensed Product and
the Lamp in the Territory are obtained, INC shall regularly and promptly report PHARMA in
reasonable detail about the status of the filing and examination procedure. Such reports
shall be rendered no less than once per Quarter Year. |
| b. | After
the First Commercial Sale in the Territory, INC shall furnish PHARMA, following the end of
each three (3) months period, with a report of INC’s sales of Licensed Product and
Lamps under this Agreement and of the expectations for the coming twelve (12) months. Each
such report shall (i) be furnished to PHARMA within thirty (30) days after the close of the
three (3) months period to which it corresponds; (ii) state INC’s total sales of the
Licensed Product; (iii) specify the sales prices and placements of Lamps; (iv) place a
binding order for the next six months; and (v) provide evidence in reasonable detail
about the marketing and sales strategy and expenditures invested in the Product in the preceding
Commercial Year. |
| c. | The
Parties shall, each time following PHARMA’s receipt of INC’s aforementioned report
and the forecasts for the Product and the Lamp discuss the respective report and agree on
all relevant topics. |
| d. | In
relation to the exploitation of the License, including the sale and offering for sale and
other commercialization of the Licensed Products and the Lamps, INC will comply with all
laws and regulations as applicable from time to time in the respective countries of the Territory.
This shall particularly apply to the compliance with the rules and regulations relating to
the commercialization of Licensed Products and Lamps and to any laws, which prohibit or limit
the permissibility to provide, directly or indirectly, anything of value (including payment
of money) to an official of a Regulatory Authority or other government body in order to obtain
or retain business or favorable treatment and requires the maintenance of accurate books
of account, with all company transactions being properly recorded. |
| a. | All
payments due to PHARMA or BIOSCIENCE shall be made by INC by bank transfer to the following
account of PHARMA: |
[***]
| b. | All
payments by INC to PHARMA or BIOSCIENCE are exclusive of value added tax, which shall, if
applicable, be invoiced separately. |
| c. | If
and to the extent INC should be required by law to withhold any part of any payment to be
made to PHARMA or BIOSCIENCE pursuant to this Agreement and to transfer such part of the
payment to any tax authority of any country as a withholding tax or any equivalent thereof,
INC shall, in relation to PHARMA or BIOSCIENCE, be entitled to do so, provided, however,
that INC shall keep the other Party promptly informed about any such withdrawal and the current
status of the respective proceedings at all times. INC shall do all such lawful acts and
things and sign all such lawful deeds and documents as PHARMA and/or BIOSCIENCE may reasonably
request from INC to enable PHARMA and/or BIOSCIENCE to take advantage of any legal provision
or double taxation treaties, which may prevent any tax being imposed or withheld by taxing
authorities with respect to the respective payment to be made by INC to PHARMA or BIOSCIENCE
pursuant to this Agreement. Without limiting the generality of the foregoing, if and to the
extent applicable, INC shall in particular procure that PHARMA and BIOSCIENCE receive, as
soon as practicable, the receipt by the responsible tax authority about the payment of any
such withholding tax deducted from the payment due to PHARMA or BIOSCIENCE. |
| d. | In
the event of any delay in effecting any payment due to PHARMA or BIOSCIENCE under this Agreement
by the due date, INC shall pay the other Party, in addition to the overdue amount, interest
calculated on a daily basis on the overdue payment, from the day after such payment was due
to the date of actual payment, at an annualized rate of [***] percentage points over
EURIBOR as applicable from time to time. |
5. | SUPPLY
OF LICENSED PRODUCTS. |
| 5.1. | PHARMA
will be the sole supplier of the Product and the Lamp. The Product and the Lamp will be purchased
by INC exclusively from PHARMA according to this Agreement. |
| 5.2. | PHARMA
shall manufacture, or have manufactured, and sell to INC all quantities of the Licensed Product
or the Lamp as may be ordered by INC pursuant to this Agreement as long as the ordered amount
is required for marketing the Product in the Territory. |
| 5.3. | INC
will, at its own cost, organize the shipment of the Licensed Product according to the legal
regulations that apply for pharmaceuticals from the sites of manufacturing to the destination
provided in INC’s order and be responsible for import into the USA. PHARMA will organize
the shipment for the Lamp according to the legal regulations that apply for medical devices
from the sites of manufacturing to the destination provided in INC’s order and be responsible
for import into the USA. PHARMA will bill INC with the costs of the shipments. Alternatively,
the parties will in the Quality Assurance Agreements agree on an arrangement that is commercially
similar. Any order placed by INC will define the destination for the delivery of the Product
or the Lamps. Incoterms used for shipment of PRODUCTS from Pharma to INC shall be CFR for
Ameluz ® and DDP for BF RhodoLED®. |
| 5.4. | PHARMA
shall use its best efforts to supply the Licensed Product and the Lamps ordered by INC in
accordance with Section 6.1 and 6.2. |
| 5.5. | INC
and PHARMA will agree on a reasonable forecasting system that allows PHARMA to plan the manufacturing
of both Product and Lamp for timely delivery, taking the constraints of the contract manufacturing
process into account. |
| 6.1. | Payment
due to PHARMA for the Licensed Products and the Lamps shall be made by INC no later than
thirty (30) days after the date of PHARMA’S invoice by bank transfer to a bank account
designated in Section 4.1. |
| 6.2. | The
price of any unit of the Licensed Product supplied by PHARMA to INC according to this Agreement (the “Transfer
Price”) shall, subject to what is set out in Sections 6.2 - 6.5, be based on certain percentages of the
“Anticipated Net Price Per Unit”, i.e. the gross price INC or its Affiliates, respectively, are reasonably
anticipating, but consistent with the terms of Section 6.3 below, to charge to their unrelated Third Party customers in good faith,
arm’s length transactions, for the supply of the Licensed Products during the following Commercial Year less any allowable
deductions as detailed under the definition of Net Sales (the “Deductions”), attributable to i) the cost of goods
sold (“COGS”), ii) regulatory services as described in Section 10.1 and 10.5 (“Contracted Services”), and
iii) a royalty, as specified below: |
| - | COGS:
18% of the Anticipated Net Price Per Unit. |
| - | Contracted
Services: 2% of the Anticipated Price Per Unit. |
| - | Royalty:
For sales of Licensed Products i) during the years 2024-2025, and ii) at any time
for the treatment of acne: 5%; For sales of Licensed Products during the years 2026-2028:
10%; For sales of Licensed Products during the years 2029-2031: 12%; For sales of Licensed
Products during the year 2032 and beyond 15%. |
| | |
| | For
the avoidance of doubt, the fixed royalty percentage of 5% referenced in item “ii”
directly above shall apply to sales of the Licensed Products for the treatment of acne only.
The heightened royalty percentages applicable in 2026 and beyond shall apply to all sales
of the Licensed Products for any indication except for acne, including sales related to AK,
BCC, and/or SCC resulting from the completion of the Ongoing Trials. |
In
any event, the Transfer Price shall not be less than i) for standard commercial units, [***] US dollars ($[***]) per unit,
and ii) for sales to US Government entities (including but not limited to the Department of Veterans Affairs), [***] US dollars
($[***]) per unit. Any deduction shall be documented in reasonable detail and subject to audit by PHARMA. The Transfer Price shall
always be subject to any applicable value added tax or similar sales taxes.
| 6.3. | For
the first full Commercial Year and all subsequent following Commercial Years, the
Anticipated Net Price Per Unit shall be based on the “Actual Net Price Per Unit”
(i.e. Net Sales per unit per 6.1 above), charged by INC to its customers for the supply of
the Licensed Products during the immediately preceding Commercial Year, save that where it
is known that one or more events will impact on the anticipated net price per unit for the
current Commercial year, this may be taken into account (e.g. mandatory government rebates
or price reductions for reimbursed products, change in mix of non-reimbursed/ reimbursed
sales, etc.). |
| 6.4. | Within
one month of the end of a Commercial Year, INC will inform PHARMA about the INC Net Price
per Unit actually achieved during the Commercial Year concerned. |
| 6.5. | In
the event of any over- or underpayments resulting from (i) any differences between the Anticipated
Net Price Per Unit and the Actual Net Price Per Unit, and/or (ii) any retroactive adjustments
of the Transfer Price applied during a certain Commercial Year according to Section 6.3,
respectively, any such over- or underpayments (as applicable) shall be adjusted. For this
purpose, INC shall, with in thirty (30) business days following the end of each Commercial
Year, provide PHARMA with a written statement showing, for the sales effected in each country
of the Territory during the subject Commercial Year, |
| a. | the
INC anticipated net price per unit initially applied; |
| b. | the
INC Actual Net Price Per Unit actually charged by INC and/or its Affiliates, respectively,
to their unrelated Third Party customers in good faith, at arm’s length transactions; |
| c. | the
Actual Sales Units; |
| e. | for
each relevant portion of Actual Sales Units, the resulting Transfer Price (in each case both
as a percentage and in currency amounts); and |
| f. | any
resulting over- or underpayment made by INC during the subject Commercial Year. |
If,
according to the aforementioned calculation, there is an underpayment by INC, INC shall pay the underpaid amount at the latest within
an additional thirty (30) days. Likewise, if, according to the aforementioned calculation, there is an overpayment by INC, PHARMA shall
pay the overpaid amount to INC within an additional thirty (30) days.
| 6.6. | PHARMA
shall provide INC with units of the Licensed Product for distribution to dermatologists or
hospitals as free samples. Such sample units of the Licensed Product will be labeled accordingly.
They will be provided to INC by PHARMA at the same conditions as the ordinary product, except
that the Transfer Price will be US Dollar [***] per unit. |
| 6.7. | PHARMA
will provide INC with the Lamp at PHARMA’s manufacturing costs plus a handling fee
of [***]%. Calculation is based on total manufacturing costs as reasonably calculated
based on GAAP not including customs, value added taxes or similar sales taxes or surcharges.
Costs shall be reasonably adjusted from time to time as changes in manufacturing or delivery
costs occur. |
| 6.8. | All
prices shall be net of any applicable value added tax or other sales taxes. |
| 7.1. | Improvements
by PHARMA. |
| a. | INC
hereby acknowledges that PHARMA is the owner of all Inventions and/or Improvements developed
by PHARMA, and INC shall acquire no rights, title or interest whatsoever in or to any such
Inventions and/or Improvements, except as specifically provided herein. The foregoing also
applies to any share of such Inventions and Improvements to the extent that PHARMA has, jointly
with INC, contributed to the development of the respective Invention and/or Improvement. |
| b. | In
the event that, during the Term, PHARMA and/or BIOSCIENCE develop any Improvements with respect
to the use of Licensed Products in the Field, PHARMA and/or BIOSCIENCE will, and hereby do,
grant INC an exclusive, royalty-free, fully paid-up license in the Field and in the Territory
to use, import, distribute, market, offer for sale and sell such Improvements during
the Term. |
| c. | A
complete list of the Improvements that are currently in development by PHARMA and/or BIOSCIENCE
is provided as Exhibit A. PHARMA and/or BIOSCIENCE may, but are not obligated to, pursue
additional future Improvements (i.e. those Improvements that are not listed on Exhibit A)
at their own cost for the improvement of the US label of the Licensed Product(s) in order
to further exploit the market potential of such Product(s). |
| a. | PHARMA
and BIOSCIENCE hereby acknowledge that INC is the owner of all Improvements developed by
INC, and PHARMA and BIOSCIENCE shall acquire no rights, title or interest whatsoever in or
to any such Improvements, except as specifically provided herein. |
| b. | The
Parties agree that for all Improvements by INC not listed in Exhibit A and referenced in
Section 7.4, INC will grant PHARMA and/or BIOSCIENCE an exclusive license to use such Improvements
outside of the Territory during the Term. The price for said license shall be agreed upon
in good faith by the Parties by taking the market size in which PHARMA and BIOSCIENCE will
use the Improvement, as compared on a percentage basis to the total worldwide markets where
Ameluz® is sold and applying this percentage to the total cost of development of the
Improvement. This royalty shall be payable to INC by BIOSCIENCE and/or PHARMA upon the first
occurrence of BIOSCIENCE and/or PHARMA’s use of any non-public or proprietary documents
for the Improvements to be included in any product label application, filed with any government
agency outside the US. |
| | |
| c. | For
all Improvements by Inc for the treatment of acne (the “Acne Trials”), during
the Term, INC will, and hereby does, grant PHARMA and BIOSCIENCE an exclusive, royalty-free,
fully paid-up license to use such Improvements during the Term. |
| 7.3. | Improvements
by BIOSCIENCE. |
| a. | INC
hereby acknowledges that BIOSCIENCE is the owner of all Inventions and/or Improvements developed
by BIOSCIENCE, and INC shall acquire no rights, title or interest whatsoever in or to any
such Inventions and/or Improvements, except as specifically provided herein. The foregoing
also applies to any share of such Inventions and Improvements to the extent that BIOSCIENCE
has, jointly with INC, contributed to the development of the respective Invention and/or
Improvement. |
| 7.4. | Transfer
of Improvements in Development by BIOSCIENCE. |
| a. | On
or before June 1, 2024, PHARMA and/or BIOSCIENCE shall transfer all remaining and ongoing
efforts towards completing “Improvements that are currently in development” as
described in Section 7.1(c) (the “Ongoing Trials”) to INC. A complete list of
the Improvements that are currently in development is provided as Exhibit A. Upon said transfer,
all Improvements from Ongoing Trials shall be subject to the provisions of Section 7.2.,
except as specified below: |
| | |
| | i.
CT013 (sBCC) and CT018 (AK – Phase 1) – ownership of resulting Improvements shall
remain with PHARMA and/or BIOSCIENCE. |
| | ii.
CT014 (Acne) and CT019 (AK - Periphery) - ownership of resulting Improvements shall be split
between INC and PHARMA/BIOSCIENCE equally (50/50). |
| b. | PHARMA
and/or BIOSCIENCE shall use their best efforts to assist with transferring the Ongoing Trials
to INC. In doing so, PHARMA and BIOSCIENCE shall i) at INC’s discretion, and to the
extent PHARMA and/or BIOSCIENCE may do so, permit INC to step into any and all existing contracts
related to the Ongoing Trials such that INC will replace PHARMA and/or BIOSCIENCE as a party
to these contracts (the “Transferrable Contracts”), ii) transfer the employment
of certain key personnel (the “Transferrable Personnel”) necessary for INC to
continue the Ongoing Trials without disruption, and iii) take all reasonable steps necessary
to establish INC as the entity overseeing the Ongoing Trials. |
| c. | The
Parties agree that INC will perform, with BIOSCIENCE’s consent, all clinical trials
under BIOSCIENCE’s Investigational New Drug (IND) for Ameluz®. A list of all currently
identified and agreed upon Transferrable Contracts and Transferrable Personnel is included
as Exhibit A. Notwithstanding the foregoing, in the event that PHARMA and/or BIOSCIENCE are
unable to transfer any Transferrable Contracts or Transferrable Personnel in good faith on
or before June 1, 2024, for any reason, i) all costs and expenses associated with such Transferrable
Contracts and Transferrable Personnel after June 1, 2024 shall nevertheless be paid by INC
or reimbursed to PHARMA and/or BIOSCIENCE by INC to the extent such costs and expenses are
paid by PHARMA and/or BIOSCIENCE, and ii) if PHARMA and/or BIOSCIENCE determine, in their
sole discretion, that the transfer to INC of any Transferrable Contracts or Transferrable
Personnel cannot be accomplished in good faith without undue hardship or excess time or expense,
PHARMA and/or BIOSCIENCE shall have the right, in their sole and absolute discretion, to
terminate any such Transferrable Contracts or Transferrable Personnel and shall thereafter
no longer be responsible for any costs or expenses associated therewith, and such termination
of any such Transferrable Contracts or Transferrable Personnel shall not constitute a breach
of this Agreement. INC agrees to honor the terms and conditions of all Transferrable Contracts
and employment terms and conditions of Transferrable Personnel, and PHARMA and/or BIOSCIENCE
shall in no way be liable or held responsible for any changes to such terms and conditions
as a result of the transfers referenced herein. |
| d. | Following
the transfer of the Ongoing Trials to INC by PHARMA and/or BIOSCIENCE, INC may, but is not
obligated to, organize and finance the Ongoing Trials until their completion at its own cost
for the improvement of the US label of the Licensed Product(s) in order to further exploit
the market potential of such Product(s). Such financing by INC shall include all current
Clinical Trial Monitors employed with respect to any Ongoing Trials. |
| e. | For
all Improvements from Ongoing Trials, during the Term, INC will, and hereby does, grant PHARMA
and BIOSCIENCE an exclusive, royalty-free, fully paid-up license to use such Improvements
during the Term. |
| | |
| f. | During
the years 2025 through 2030 INC will, on average, fund research and development activities
to pursue Improvements (“Inc R&D”) in an amount that is at least 85% of the
difference between i) the Transfer Price for Product determined by this Agreement, dated
February 8, 2024, and ii) the Transfer Price for Product as it would have been determined
by the previous iteration of this Agreement, dated October 8, 2021, which shall equal the
“Minimum R&D Costs”. Should INC fail to fund INC R&D with the Minimum
R&D Costs, INC will pay to AG the difference between x) the actual amount spent on Inc
R&D and y) the Minimum R&D Costs, which shall equal the “R&D True-Up”.
The R&D True-Up, if any, shall be paid to PHARMA on February 15, 2031, and may be paid
in either cash or BFRI common stock, at INC’s discretion. If INC elects to pay the
R&D True-Up in BFRI common stock, the value of the shares of BFRI common stock shall.
be determined by the average NASDAQ share price during January 2031. |
| g. | The
Parties agree that for the Ongoing Trials, INC may require information technology
and regulatory support from BIOSCIENCE and/or PHARMA. In such an event, the Parties shall
negotiate in good faith to enter into any service agreements with respect to such support,
which support is to be provided by BIOSCIENCE and/or PHARMA. In addition, the Parties agree
that BIOSCIENCE and/or PHARMA shall be entitled to receive rental payments from INC with
respect to any building or other space owned or leased by BIOSCIENCE and/or PHARMA that is
used by INC for purposes of any Ongoing Trials or future trials or other pursuits of Improvements.
The amount of such rental payments shall be at market rates or other amount as agreed upon
by the Parties pursuant to good faith negotiations. |
8. | PHARMA
PATENT AND TRADEMARK RIGHTS. |
| 8.1. | Information
and Consultation. |
| a. | PHARMA
and BIOSCIENCE shall keep INC reasonably informed and shall consult with INC on an ongoing
basis regarding the prosecution of the Patents and trademarks comprised within the PHARMA
IP and any actions which are required to be taken in relation thereto, and shall notify INC
as soon as practicable of any event that is reasonably anticipated to impact the preparation,
filing, prosecution, and/or maintenance of any patents, patent applications, or trademarks
within the PHARMA IP. INC shall furnish PHARMA and BIOSCIENCE with at least thirty (30) days
written notice prior to the First Commercial Sale of any of the Licensed Products in any
country within the Territory, in order to permit PHARMA or BIOSCIENCE to take such action
as the Parties collectively determine to be necessary or appropriate to protect and perfect
PHARMA or BIOSCIENCE’s rights, title and interests in and to all of PHARMA IP in that
country. In the event that the Parties cannot agree whether certain actions are necessary
or appropriate to protect and perfect PHARMA or BIOSCIENCE’s rights, title and interests
in and to all of PHARMA IP, PHARMA or BIOSCIENCE may request that INC bears some or all of
the cost of the disputed action, to be negotiated in good faith between the parties
at the time said dispute arises. Under no circumstances may PHARMA or BIOSCIENCE refuse to
undertake actions that INC reasonably determines to be necessary or appropriate to protect
and perfect PHARMA or BIOSCIENCE’s rights, title and interests in and to all of PHARMA
IP. |
| b. | Notwithstanding
Section 8.1(a), PHARMA and BIOSCIENCE shall not seek and shall not be entitled to receive
financial contribution from INC towards any efforts to protect and perfect PHARMA or BIOSCIENCE’s
rights, title and interests in and to all of PHARMA IP unless such actions were initiated,
in whole or in part, by INC. PHARMA and BIOSCIENCE shall remain fully financially responsible
and liable for any and all efforts to protect and perfect PHARMA or BIOSCIENCE’s rights,
title and interests in and to all of PHARMA IP initiated independently from INC. |
| 8.2. | Third
Party Infringements. |
| a. | If
any of INC, PHARMA, or BIOSCIENCE becomes aware of any activity that it believes represents
an infringement of any of the PHARMA IP, the Party obtaining such knowledge shall promptly
advise, to the extent that such information is available to the respective Party, the others
of all relevant facts and circumstances relevant to the potential infringement. INC. PHARMA,
and BIOSCIENCE shall thereafter consult and cooperate fully to determine a course of action,
including but not limited to the commencement of legal action to terminate any infringement
of the PHARMA Patent Rights. However, PHARMA shall have the first right, but not the obligation,
to bring, defend, or maintain any suit or action, against any actual, threatened, or suspected
infringement of any of the PHARMA IP in the Territory. In the event that PHARMA is involved
in any such legal action, to the extent necessary, BIOSCIENCE shall join such legal action
as a party and PHARMA shall keep INC apprised of all significant activities and decisions,
including but not limited to consulting INC regarding settlement of infringement claims. |
| b. | If
PHARMA decides to exercise such right and so to bring, defend or maintain any such suit or
action, PHARMA is obliged to sue an alleged infringer within (i) 120 (one hundred twenty)
days of the date of notice of such infringement, or (ii) 30 (thirty) days before the time
limit, if any, set forth in the applicable laws and regulations for the filing of such actions,
whichever comes first. PHARMA shall in this case be responsible for taking all actions, in
the courts, administrative agencies, or otherwise, including a settlement, to prevent or
enjoin any and all such infringements and other unauthorized uses of the respective PHARMA
IP, and INC shall take no action with respect to any such infringement or unauthorized use
of PHARMA IP, without the prior written authorization of PHARMA; provided, however, that
INC shall provide at the request and cost of PHARMA such assistance as PHARMA shall reasonably
request in connection with any action to prevent or enjoin any such infringement or unauthorized
use of any of PHARMA IP. |
| c. | In
the event PHARMA decides not to exercise its right under Section 8.2(b) prior to the applicable
timeline pursuant to Section 8.2(b), PHARMA shall promptly notify INC of its decision in
writing, INC shall then have the right, but not the obligation, to take such action as INC
may deem appropriate to prevent or enjoin the alleged infringement or threatened infringement
of the respective PHARMA IP, and if INC exercises this right, PHARMA and BIOSCIENCE shall
provide reasonable assistance to INC at the request and cost of INC, including but not limited
to joining in the action as parties. In the event INC requires action against the alleged
infringer and PHARMA, after (i) expiration of the applicable timeline pursuant to Section
8.2(b), and (ii) being notified by INC in writing of the breach and the proposed action,
is unable or unwilling to take such action, INC shall then have the right, but not the obligation,
to take such action as INC may deem appropriate to prevent or enjoin the alleged infringement
or threatened infringement of the respective PHARMA IP, and if INC exercises this right,
PHARMA and BIOSCIENCE shall provide reasonable assistance to INC at the request and cost
of INC, including but not limited to joining in the action as parties. |
| d. | Any
damage award or settlement payments, made in connection with any action relating to infringement
of the PHARMA IP in the Territory, whether obtained by judgment, settlement or otherwise
shall be allocated in order or decreasing priority as follows: (i) to the Party which initiated
and prosecuted the action to recoup all of its costs and expenses incurred in connection
with the action, (ii) to the other Party, to recover its costs and expenses incurred in connection
with the action, and (iii) the amount of any remaining monies shall then evenly be split
between PHARMA and INC. |
9. | JOINT
PATENT RIGHTS TO JOINT RESULTS. |
| 9.1. | Joint
Patent Rights. All patentable inventions created, generated, conceived, made, developed,
or reduced to practice jointly by INC, on the one hand, and PHARMA and/or BIOSCIENCE, on
the other hand, (including their respective Affiliates or other persons or entities on behalf
of INC and PHARMA or BIOSCIENCE) during the Term and/or during the continuance of
the Term shall be the joint property of INC and PHARMA each of whom shall have a 50% ownership
in the respective invention. The Parties will document when a patentable invention
qualifies as a “joint invention” prior to the filing of the first patent application,
including a provisional application if filed. Each Party shall take all steps reasonably
required to ensure that the right to any such inventions are transferred to such Party to
the maximum extent permissible under applicable law, including without limitation, the German
employees invention act (Gesetz uber Arbeitnehmererfindungen) or respective foreign laws
as applicable from time to time. In this regard the Party represents that each of its respective
employees has entered into a written contract of employment that provides for assignment
of all inventions made by said employee during the course of his/her employment to the respective
Party. Furthermore, the Parties shall ensure that other persons who are not employees of
any Party (e.g. graduate students, doctoral candidates etc.) shall only participate in any
activities under this Agreement when and after they have duly assigned all rights to research
results, including in particular joint inventions, to the respective Party. No Party shall
assign or transfer their respective shares in any such jointly owned patentable inventions
or in any patent applications filed therefore or in any patent granted in respect of any
such jointly owned patentable inventions (all together the “Joint Patent Rights”)
to any Third Party without the other Party’s prior written consent. |
| 9.2. | Prosecution
of Joint Patent Rights. The Parties will decide on a case by case basis which Party will
have the responsibility for handling the filing, prosecution and maintenance of any Joint
Patent Rights. In making such a decision, the principles observed by the Parties will be
the respective contributions of each Party to the joint invention, the standards and
customs in the industry and expected efficiency in patenting procedures. Unless agreed
otherwise, the Parties will each bear 50% of the costs of such filing, prosecution and maintenance
of Joint Patent Rights and any recoveries will be split 50/50. |
| 9.3. | Exploitation
of Joint Patent Rights. Joint Patent Rights shall be filed in the name of PHARMA and
INC and each Party shall procure that its respective inventors assign all of their rights
and interests to such Joint Patent Rights to PHARMA and INC. Notwithstanding what is set
forth in Section 7, PHARMA and INC shall each be free to use and exploit the Joint Patent
Rights for any purpose whatsoever. Each Party shall bear any cost arising out of any obligation
to remunerate an employee or any other Third Party for making or contributing to the respective
invention, e.g. pursuant to the German employees inventions act (Gesetz über Arbeitnehmererfindungen).
PHARMA and INC shall indemnify each other for any such remuneration which becomes payable
due to the exploitation of any of the Joint Patent Rights by the other Party. |
| 9.4. | Discontinuance.
In each case, whichever Party files, prosecutes, and maintains the Joint Patent Rights
(“Prosecuting Party”) shall keep the other Party informed of the filings, prosecution,
and maintenance reasonably in advance of any relevant actions and deadlines to allow for
review and consultation. In the event that the Prosecuting Party elects not to continue prosecuting
or maintaining any of the Joint Patent Rights, the Prosecuting Party shall give to the other
Party, if possible, thirty (30) days, but in any event not less than ten (10) days, written
notice before any relevant deadline relating to or any public disclosure of the relevant
Joint Patent Rights. Upon receipt of a notice from the Prosecuting Party indicating that
it intends to cease prosecuting or maintaining any of the Joint Patent Rights, the other
Party shall have the right to continue, at its own expense, prosecution or maintenance (as
the case may be) of the relevant patent rights and to request the assignment of such right.
The Prosecuting Party shall at the request and cost of the other Party do all such acts and
execute all such documents as may be necessary to assist the other Party with the prosecution
or maintenance of such patent right as well as with the assignment and transfer of such patent
right to the other Party. |
| 10.1. | PHARMA
and BIOSCIENCE will be responsible for obtaining and maintaining the rights to all FDA Approvals
and any amendments or supplements required in order for INC to sell or distribute the Products
in the Territory in the Field, and PHARMA and BIOSCIENCE shall be responsible for obtaining
and maintaining all FDA Approvals and any amendments or supplements required in order for
PHARMA to manufacture or have manufactured the Products and Lamps. |
| 10.2. | INC
will be responsible to get all state licenses or any other approvals required to market Products
and Lamp. |
| 10.3. | INC
will further undertake to furnish all reporting mandatory according to national and state
law with respect to compliance with the Prescription Drug Marketing Act and the Sunshine
Act or any other applicable law or regulations. |
| 10.4. | INC
will inform Pharma and BIOSCIENCE about any new advertising material and provide copies of
advertising and promotional material for submission to the Office of Prescription Drug Promotion
(OPDP) according with the requirements described in 21 CFR 314.81(b)(3)(i). INC will furthermore
support Pharma as necessary for the preparation of the submission and annotation of the advertising
and promotional material. INC will not use any advertising material prior to PHARMA’s
submission of such material to the FDA. |
| 10.5. | BIOSCIENCE,
in each case, will be responsible to (i) maintain, at its (or PHARMA’s, as applicable)
own cost and expense, the regulatory Approval in full force and effect, (ii) maintain a pharmacovigilance
database, and (iii) respond appropriately to all relevant queries of any Regulatory Authority
in the Territory. Notwithstanding BIOSCIENCE’s responsibility to this clause 10.5,
INC will, upon reasonable request of BIOSCIENCE or PHARMA, render BIOSCIENCE or PHARMA, as
applicable, all reasonable support relating to any regulatory issues relating to the Territory.
In particular, INC shall fully cooperate in all aspects relating to pharmacovigilance and
product recalls. |
| 10.6. | INC
will, at its own cost, be responsible for all contacts, applications, and/or filings required
for any agreement with health care providers with respect to the reimbursement and pricing
of the Product in the Territory. |
| 10.7. | Details
on responsibilities and regulatory obligations with respect to pharmacovigilance of the Product
and vigilance of incidences with the Lamp will be agreed upon in separate Safety Data Exchange
Agreements that will be closed in due time after signing this Agreement, but before First
Commercial Sale of the Product in the Territory. |
| 10.8. | Details
on responsibilities and regulatory obligations regarding handling of Product complaints and
launching of product recalls will be agreed upon in separate Quality Assurance Agreements
that will be agreed upon by the Parties in due time after signing this Agreement, but before
the First Commercial Sale of the Product in the Territory. |
| 10.9. | Further
Details on regulatory responsibilities will be agreed upon in the Quality Assurance Agreement. |
| 10.10. | Except
as otherwise set forth herein, any clinical trials planned by INC in any way whatsoever involving
the Licensed Product and/or the Lamp will be presented and discussed with PHARMA and BIOSCIENCE
well before the start of such trials. No such clinical trials will be performed without the
prior written approval by and close collaboration with PHARMA. |
| 10.11. | Should
PHARMA or BIOSCIENCE not commit to their obligations under Section 10.1. or Section 10.5.,
then the Parties agree herewith, that the US Approval Holders of the Product and the Lamp
(BIOSCIENCE) will be obliged to transfer these approvals to INC or another legal entity nominated
by INC without any delay and at their own cost. INC will thereafter be responsible for all
obligations towards the US agencies. Starting at the date at which PHARMA or BIOSCIENCE has
failed to commit to their obligations under Section 10.1. or Section 10.5., the Transfer
Price will be reduced by [***]% of net sales. |
| a. | co-operate
with one another and share information concerning the safety and efficacy of the Products
in accordance with current European Union and U.S. Pharmacovigilance requirements; and |
| b. | notify
each other in writing as soon as reasonably possible of any information or announcement coming
to their attention, as well as the origin of such information or announcements with regard
to: |
| i. | adverse
events which are observed in relation to the Product; or |
| ii. | characteristics
which could impair the safety or efficacy of the Product. |
| 11.2. | Whenever
a recall and/or withdrawal of Product or Lamp in Territory is being contemplated for any
reason whatsoever, both Parties shall promptly consult with each other for the purpose of
deciding the appropriate action to be taken. However, ultimate responsibility to recall or
withdraw the Product or the Lamp shall rest with Biofrontera Bioscience GmbH as holder of
the relevant Marketing Authorization. PHARMA will investigate or procure the investigation
of all Product or Lamp quality complaints reported by INC and the management of complaints
and recalls will be defined in the Quality Assurance Agreement. |
| 11.3. | The
costs and expenses directly related to any recall or withdrawal of the Product which is due
to a breach of INC’s obligations herein shall be borne by INC. In all other cases the
costs and expenses directly related to any recall or withdrawal of the Product shall be borne
by PHARMA. |
12. | MANUFACTURE
AND QUALITY CONTROL. |
| 12.1. | PHARMA
shall manufacture or have manufactured all the Products and Lamps supplied to INC hereunder
in accordance with all of the following: |
| a. | all
product specifications and requirements within the Regulatory Approval; |
| b. | all
applicable Good Manufacturing Practices (GMP); and |
| c. | all
other applicable laws and regulations in connection with the manufacture, shipment, handling
and distribution of the Products including, but not limited to, the Regulatory Approvals. |
| 12.2. | PHARMA
shall perform QC testing and thereafter provide INC with the Certificate of GMP Compliance
and the Certificate of Analysis confirming that the Products have met all current and applicable
Product specifications and requirements set forth in this Agreement or as modified according
to future amendments of the regulatory approval. |
| 12.3. | PHARMA
will quality check all Lamps according to the Specifications prior to shipment. INC will
check the Lamps promptly after arrival for any obvious damages. The lamp will be covered
by the standard 2-year warranty for manufacturing defects. |
| 12.4. | INC
may reject, within ten (10) working days of actual receipt, any or all of a shipment of Product
and, within twenty (20) working days of actual receipt, any or all of a shipment of Lamps
that INC reasonably determines does not conform to the Product specifications and PHARMA
shall replace any non-conforming Products at PHARMA’s expense. |
| 12.5. | Upon
justified request by INC, PHARMA shall send a new shipment of the Products or Lamps to INC
(of similar quantity as the batch of the Products and at the selling price and on such other
terms and conditions as set forth herein) so as to enable INC to continue to supply the Products
and Lamps to its customers. In the event that the Parties agree, or in the event that any
of the Products or Lamps is verified as defective or not in conformity with the Products
specifications, replacement shall be made by PHARMA as expeditiously as reasonably possible. |
| 12.6. | INC
shall not be obligated to pay for any shipment (or partial shipment) of the Products or Lamps
which does not conform to the Product specifications as in place and amended at the time
of shipment. If INC notifies PHARMA that any or all of a shipment of the Products or Lamps
do not conform to the specifications, then payment for such shipment shall be delayed until
resolution of the discrepancy by consultation between the Parties. Any units of the Products
or Lamps that are determined by agreement between the Parties not to conform to the relevant
Product or Lamp unit specifications shall, at PHARMA’s option and at PHARMA’s
expense, either be returned to PHARMA or destroyed by INC in accordance with PHARMA’s
instructions. |
| 12.7. | In
the case that PHARMA fails to deliver Products or Lamps to INC in conformance with this Section
12 and the Quality Assurance Agreement, and if PHARMA fails to remedy its failure in accordance
with this Agreement, then the Parties herewith agree that INC will have the right to organize
manufacturing on its own, and step into the contracts with PHARMA’s manufacturers,
such that INC will replace PHARMA as a party to these contracts with regards to the manufacture
of Products and Lamps for the Territory only. If INC elects to pursue this option, i) PHARMA
must use its best efforts to assist with the transferring of said manufacturing contracts
to INC and otherwise establishing INC as the new manufacturer of the Products, without delay
and at its own cost, and ii) no transfer price will be paid to PHARMA thereafter for products
or lamps that are manufactured by third parties. |
| 13.1. | Disclosure
of Confidential Information. Except as explicitly stated herein, nothing in this Agreement
shall obligate a Party to disclose any Confidential Information, rather any such disclosure
shall be in the sole discretion of the Party Controlling such Confidential Information sole
discretion. The Parties will use commercially reasonable efforts, consistent with reasonable
business practices, to (i) label or identify as “CONFIDENTIAL”, at the time of
disclosure or, by written notice to the other Party, within thirty (30) days following such
disclosure, Confidential Information, which is disclosed in writing or in tangible form,
and (ii) reduce to writing and/or other tangible form and similarly label, within thirty
(30) days of disclosure, Confidential Information, which is disclosed verbally, or in other
non-tangible form, unless such information is of the type that is customarily considered
to be confidential information by persons engaged in activities that are substantially similar
to the activities being engaged in by the Parties. |
| 13.2. | Obligation
not to Disclose. All Confidential Information disclosed, revealed or otherwise made available
by one Party (“Disclosing Party”) to the other Party (“Receiving Party”)
under, or as a result of, this Agreement is furnished to the Receiving Party solely to permit
the Receiving Party to exercise its rights, and perform its obligations, under this Agreement.
The Receiving Party shall not use any of the Disclosing Party’s Confidential Information
for any other purpose, and shall not disclose, reveal or otherwise make any of the Disclosing
Party’s Confidential Information available to any other person, firm, corporation or
other entity, without the prior written authorization of the Disclosing Party. |
| 13.3. | Appropriate
Safeguards. In furtherance of the Receiving Party’s obligations under Section 13.2.
hereof, the Receiving Party shall take all appropriate steps, and shall implement all appropriate
and reasonable safeguards, to prevent the unauthorized use or disclosure of any of the Disclosing
Party’s Confidential Information. Without limiting the generality of this Section 13.3.,
the Receiving Party shall disclose any of the Disclosing Party’s Confidential Information
only to those of its officers, employees, (potential) financial investors, advisors and consultants,
that have a need to know the Disclosing Party’s Confidential Information, in order
for the Receiving Party to exercise its rights and perform its obligations under this Agreement,
and only if such officers, employees, (potential) financial investors, advisors and consultants,
are bound by appropriate nondisclosure agreements containing substantially similar terms
regarding confidentiality as those set out in this Agreement or are otherwise bound by obligations
of confidentiality effectively prohibiting the unauthorized use or disclosure of the Disclosing
Party’s Confidential Information. The Receiving Party shall furnish the Disclosing
Party with immediate written notice of any unauthorized use or disclosure of any of the Disclosing
Party’s Confidential Information by any officer, employee, (potential) financial investor,
advisor and consultant of the Receiving Party, and shall take all actions that the Disclosing
Party reasonably requests in order to prevent any further unauthorized use or disclosure
of the Disclosing Party’s Confidential Information. |
| 13.4. | Exclusions.
The Receiving Party’s obligations under Sections 13.2. and 13.3. hereof shall not apply
to the extent that the Receiving Party can prove by written or equivalent evidence that any
of the Disclosing Party’s Confidential Information: |
| i. | passes
into the public domain, or becomes generally available to the public through no fault of
the Receiving Party; |
| ii. | was
known to the Receiving Party prior to disclosure hereunder by the Disclosing Party; |
| iii. | is
disclosed, revealed or otherwise made available to the Receiving Party by a Third Party that
is under no obligation of non-disclosure and/or non-use to the Disclosing Party; or |
| iv. | is
required to be disclosed under applicable law, pursuant to a document request or subpoena
in connection with a legal proceeding, or in connection with any application by the Receiving
Party for any Regulatory Approvals; provided, however, that the Receiving Party shall furnish
the Disclosing Party’s with as much prior written notice of such disclosure requirement
as reasonably practicable, so as to permit the Disclosing Party, in its sole discretion,
to take appropriate action, including seeking a protective order, in order to prevent the
Disclosing Party’s Confidential Information from passing into the public domain or
becoming generally available to the public. |
| 13.5. | Obligation
to Return. Upon expiration or termination of this Agreement for any reason whatsoever,
the Receiving Party shall return to the Disclosing Party, or destroy, as the Disclosing Party
shall specify in writing, all copies of all documents and other materials, including Research
Materials, that contain or embody any of the Disclosing Party’s Confidential Information,
except to the extent that the Receiving Party is required by applicable law to retain such
documents and materials. Within thirty (30) days after the date of expiration or termination
of this Agreement, the Receiving Party shall furnish the Disclosing Party with a certificate,
duly executed by an officer of the Receiving Party, confirming that the Receiving Party has
complied with its obligations under this Section 13.5. Nothing in this Section 13.5. shall
affect the right of INC to retain, for a period of five (5) years, copies of all data, documents
and other materials for the purpose of documenting its performance under this Agreement and/or
to deal with any claims or queries by individuals, associations, institutions or authorities. |
| 13.6. | Survival.
All of the Receiving Party’s obligations under Sections 13.2., 13.3. and 13.4. hereof,
with respect to the protection of the Disclosing Party’s Confidential Information,
shall survive the expiration or termination of this Agreement for any reason whatsoever by
ten (10) years. |
14. | WARRANTIES
AND LIABILITIES. |
| 14.1. | PHARMA
and BIOSCIENCE’s Warranties. PHARMA and BIOSCIENCE warrant and represent that: |
| a. | to
the best of their knowledge as of the Effective Date, they, collectively and/or individually,
own the entire right, title and interest in the PHARMA IP and the PHARMA Trademark Rights; |
| b. | they
each individually have the right to enter into this Agreement and to grant the license contained
herein; |
| c. | they
each individually have, as of the Effective Date, no knowledge from which it can be inferred
that PHARMA Patent Rights are invalid or that their exercise would infringe patent rights
of Third Parties; |
| d. | to
the best of their individual knowledge as of the Effective Date, no Third Party has any right,
title or interest in or to any of the PHARMA Patent Rights, which would be a material impediment
for INC to exploit the License. |
| 14.2. | Disclaimer.
Except as stated in this Agreement, and notwithstanding what is set forth in the Regulatory
Approval granted for the Product in the Territory, PHARMA makes no representation or warranty
and specifically disclaims any guarantee that the exploitation of the License by INC will,
technically or in business terms, be successful, in whole or in part, or that the PHARMA
Technology and the PHARMA Trademark will be suitable for commercialization. In that respect,
PHARMA expressly disclaims any warranties or conditions, express, implied, statutory or otherwise
with respect to PHARMA IP and PHARMA Know-How, including without limitation, any warranty
of merchantability or fitness for a particular purpose. |
| 14.3. | INC’s
Warranties. INC warrants and represents that |
| a. | to
the best of its knowledge as of the Effective Date, it has, together with the License, the
required freedom-to-operate to exploit the License and particularly to commercialize Licensed
Products in the Territory and in the Field; |
| b. | it
has the right and all required certificates to enter into this Agreement and to accept the
grant of the License; |
| c. | it
has no conflicting interests that may impede the commercialization of the Product and the
compliance with the terms and conditions of this Agreement. |
| 14.4. | Disclaimer.
Except as stated in this Agreement, INC makes no warranties, express or implied, with respect
to the terms of this Agreement. All other warranties not expressly stated in this Agreement,
express or implied are hereby disclaimed. |
15. | INDEMNIFICATION
AND INSURANCE. |
| 15.1. | PHARMA’s
Indemnification Obligations. PHARMA shall defend, indemnify and hold INC harmless against
any claims, suits, actions, proceedings, losses, liabilities, damages, costs and expenses
(collectively “Claims and Liabilities”) arising from, related to, or attributable
to: |
| i. | any
claim, including any product liability claim, with respect to any of the Licensed Products
and/or Lamp regardless of whether such claim is based on contract, breach of warranty, any
form of tort, strict liability, or otherwise; |
| ii. | any
allegation that any of the Licensed Products and/or Lamp fail to conform with the requirements
of any applicable laws and/or any applicable Regulatory Approvals; |
| iii. | any
breach of any of PHARMA representations, warranties or covenants set forth in this Agreement;
and/or |
| iv. | any
other gross negligent, willful or intentionally wrongful act, error or omission on the part
of PHARMA, or any officer, director, employee, agent or representative of PHARMA. |
For
the avoidance of doubt, PHARMA’ s indemnification obligation under this Section 15.1 shall not apply to the extent that any Claim
and Liability is attributable to a breach, gross negligent, willful or intentionally wrongful act on the part of INC (Section 15.2).
PHARMA’s indemnification obligation under this Section 15.1 shall be subject to each of the following conditions: (i) INC shall
furnish PHARMA with written notice of any such Claims and Liabilities within 30 (thirty) days of the date on which INC receives notice
thereof; (ii) subject to PHARMA confirming in writing that the indemnity will apply to the relevant Claims and Liabilities, PHARMA shall
be solely responsible for the investigation, defense, settlement and discharge of such Claims and Liabilities; and (iii) INC shall at
PHARMA’s costs furnish PHARMA with all assistance reasonably requested by PHARMA in connection with the investigation, defense,
settlement and discharge of such Claims and Liabilities. INC’s failure to comply with its obligations pursuant to this Section
15.1 shall not constitute a breach of this Agreement or relieve PHARMA of its indemnification obligations pursuant to this Section 15.1,
except to the extent, if any, that PHARMA defense of the respective claim, action or proceeding actually was materially impaired thereby.
| 15.2. | INC’s
Indemnification Obligations. INC shall defend, indemnify and hold PHARMA harmless against
any and all Claims and Liabilities arising from, related to, or attributable to: |
| i. | any
breach of any of INC’s representations, warranties or covenants set forth in this Agreement;
and/or |
| ii. | any
other gross negligent, willful or intentionally wrongful act, error or omission on the part
of INC, or any officer, director, employee, agent or representative of INC. |
| iii. | any
office action or legal claims provoked by wrongful advertisement, pricing, sales practices,
or use of Product or Lamp in the Territory. |
For
the avoidance of doubt, INC’s indemnification obligations under this Section 15.2 shall not apply to the extent that any claim
is attributable to a breach or other gross negligent, willful or intentionally wrongful act (Section 15.1) on the part of PHARMA. INC’s
indemnification obligation under this Section 15.2 shall be subject to each of the following conditions: (i) PHARMA shall provide INC
with written notice of any such Claims and Liabilities within thirty (30) days after PHARMA receives notice of such Claims and Liabilities;
(ii) subject to INC confirming in writing that the indemnity will apply to the relevant Claims and Liabilities, INC shall be solely responsible
for the investigation, defense, settlement and discharge of such Claims and Liabilities; and (iii) PHARMA shall at INC’s cost furnish
INC with all assistance reasonably requested by INC in connection with the investigation, defense, settlement and discharge of such Claims
and Liabilities. PHARMA’s failure to comply with its obligations pursuant to this Section 15.2 shall not constitute a breach of
this Agreement or relieve INC of its indemnification obligations pursuant to this Section 15.2, except to the extent, if any, that INC’s
defense of the effective claim, action or proceeding actually was materially impaired thereby.
| 15.3. | Insurance.
Both Parties shall, at their sole cost and expense, obtain and maintain in full force and
effect during the Term and thereafter in accordance with Section 15.3 hereof, commercial
general liability insurance with coverage adequate in relation to the risks attached to the
activities conducted by the respective Party. The Parties hereby specifically acknowledge
and agree that the insurance coverage limits set forth in this Section 15.3 shall not be
construed to create any limit on each Party’s liability hereunder and/or indemnification
obligation hereunder. If a Party experiences a Change of Control, that Party shall be prohibited
from reducing its commercial general liability insurance coverage (insofar as it relates
to the activities contemplated by this Agreement) without the written consent of the other
Party for a period of twelve (12) months. |
| 15.4. | Survival.
PHARMA’s indemnification obligation under Section 15.1 hereof, INC’s indemnification
obligation under Section 15.2 hereof, and the Parties’ obligation to maintain general
liability insurance under Section 15.3 hereof, shall survive the expiration or termination
of this Agreement for any reason whatsoever for a period of five (5) years after the date
of expiration or termination hereof. |
| 15.5. | In
no event shall either Party be liable to the other Party for punitive damages arising out
of this Agreement. |
| 16.1. | Expiry
and Automatic Renewal. This Agreement shall enter into effect on the Effective Date,
and shall notwithstanding what is set forth in the following provisions of this Section 16,
remain in full force and effect through fifteen (15) years from the date of this Amendment.
The Term shall renew automatically for a period of five (5) years, in perpetuity, so long
as i) INC has earned revenues from the Products and Lamps of equal to or greater than $[***]
million over the preceding five (5) years, and ii) this Agreement has not been duly terminated
in accordance with any of Sections 16.2 through 16.6. If INC fails to earn $[***]
million in revenues from Products and Lamps over the preceding five (5) year period leading
to this Agreement’s termination date under this Section 16.1 (either fifteen (15) years
from the date of this Amendment or any later termination date following the automatic renewal
of this Agreement), PHARMA has the right to terminate this Agreement by providing one (1)
year written notice. |
| 16.2. | Early
Termination by PHARMA for Attack of PHARMA IP. PHARMA may terminate this Agreement, if
INC makes, files, or maintains any lawsuit, cause of action or other action alleging that
any of the PHARMA IP is invalid or unenforceable or is not infringed by the manufacture,
use, import, export, offer to sell or sale, or otherwise commercialization of the
Licensed Products by INC, as applicable. This provision shall be of the essence of
this Agreement. |
| 16.3. | Early
Termination for Breach. In the event that either Party (the “Breaching Party”)
commits a material breach or default of any of its obligations hereunder, the other party
hereto (the “Non-Breaching Party”) may give the Breaching Party written notice
of such material breach or default, and shall request that such material breach or default
be cured as soon as reasonably practicable. In the event that the Breaching Party fails to
cure such breach or default within 60 (sixty) days after the date of the Non-Breaching Party’s
notice thereof (or such other period of time as provided in this Agreement), the Non-Breaching
Party may terminate this Agreement as a whole or on a country-by-country basis by giving
written notice of termination to the Breaching Party. In the event the Breaching Party will
be unable to cure the breach or if such cure is impossible, this Agreement may be terminated
by the NonBreaching Party with immediate effect. Termination of this Agreement in accordance
with this Section 16.3. shall not affect or impair the Non-Breaching Party’s right
according to this Agreement to pursue any legal remedy, including, but not limited to, the
right to recover damages, for any harm suffered or incurred by the Non-Breaching Party as
a result of such breach or default. The Parties agree that for the years 2024 and 2025,
the cure period referenced in this Section shall be reduced to thirty (30) days in any instances
of non-payment by INC in accordance with Section 6.1. |
For
the purposes of this Section, a “material breach” shall be deemed to include, but not be limited to, with respect to INC,
any failure to (i) market the product according to Sections 3.1, 3.3, 3.4, 3.5 and 3.6 or make any payments required by Section 6.1,
or (ii) launch the Licensed Product by means of the First Commercial Sale within the period specified in the last sentence of Section
3.1., and with respect to PHARMA, failure to (i) provide the Products in accordance with Section 5, (ii) meet its regulatory obligations
pursuant to Section 7, or (iii) adhere to the quality standards set forth in Section 12 and/or the Quality Assurance Agreement between
the Parties.
| 16.4. | Early
Termination by PHARMA for Termination of Regulatory Approval. PHARMA shall be entitled
to, by written notice to INC, terminate the License if any Regulatory Approval or other mandatory
authorization for the Licensed Product and/or the Lamp and/or INC in the Territory should
during the Term, as a result of INC’s negligence, expire, be terminated, lapse, become
(or being declared) invalid or void, or otherwise cease to exist as a basis for the commercialization
of the Licensed Product and/or the Lamp in the Territory. |
| 16.5. | Early
Termination in the Event of Safety Issues. In the event of serious scientific, safety
and/or technical reasons or additional, unforeseeable requirements raised by a Regulatory
Authority, which (in each case) render the commercialization of the Licensed Product ethically
irresponsible and/or economically reasonably unfeasible, INC may, by giving ninety (90) days
prior written notice to PHARMA, terminate this Agreement. |
| 16.6. | Early
Termination in Case of Insolvency. Each Party shall have the right to terminate this
Agreement, immediately by giving written notice of termination to the other Party, if the
other Party files a voluntary petition, or if an involuntary petition is granted in respect
of the other Party and appeal proceedings are not commenced within a period of 7 (seven)
days from the date of such petition under the bankruptcy provisions of applicable law, or
the other Party is declared insolvent, undergoes voluntary or involuntary dissolution, or
makes an assignment for the benefit of its creditors, or fails or is unable to pay its debts
as they come due, or suffers the appointment of a receiver or trustee over all, or substantially
all, of its assets or properties. |
17. | CONSEQUENCES
OF TERMINATION. |
| 17.1. | Regular
expiration of the Term. In the event the Term expires regularly pursuant to Section 16.1., |
| a. | INC
shall have the right, for a period of 6 (six) months following the expiration of the Term,
to sell any residual stock of the Licensed Product, to the extent such Licensed Product is
still sellable and usable, and as of the expiration of the Term, in the possession of INC;
and |
| b. | PHARMA
will be prepared, on terms and conditions (including, subject to legal permissibility, exclusivity)
to be negotiated in good faith on the basis of then prevailing fair market conditions as
customary in the related industry, to further (i) supply INC with Licensed Products, and
(ii) grant INC a license to use the PHARMA Trademark. If INC should chose to source the Product
from a Third Party, but be interested to use the PHARMA Trademark for such Product, PHARMA
will, subject to further terms and conditions to be negotiated in good faith on the basis
of then prevailing fair market conditions as customary in the related industry, grant INC
a corresponding license to use the PHARMA Trademark, and INC will pay PHARMA a royalty of
[***] percent ([***]%) on any Net Sales made by INC, its Affiliates and/or
other sub-licensees with such Products. If INC should choose both to source the Product from
a Third Party and not to use the PHARMA Trademark, any and all rights of INC with respect
and in connection with the PHARMA Trademark will terminate and INC shall no longer be entitled
to make use of the PHARMA Trademark in any manner whatsoever. |
| a. | In
the event of an early termination of the Term due to PHARMA or BIOSCIENCE’s breach
of this Agreement, the License shall terminate and PHARMA and BIOSCIENCE shall: |
| i. | be
prohibited for a period of one (1) year from the date of termination from entering into a
License, exclusive or otherwise, granting any third party the right to use the PHARMA Technology
to use, import, export, distribute, market, offer for sale, and sell the Licensed Product
and the Lamp in the Territory and in the Field (the “Restricted Period”), and |
| ii. | during
the Restricted Period, negotiate in good faith with INC to enter into a new License Agreement
with terms no less favorable than the terms of this Agreement for INC to continue its marketing
and sales efforts within the Territory and within the Field. |
| b. | In
any event of an early termination of the Term the License shall terminate. INC shall, |
| i. | assign
and transfer any Regulatory Approval or other permissions for the Licensed Product and the
Lamp, including without limitation, title to any dossier and/or other information filed with
the Regulatory Authorities, free of charge to PHARMA or any designee of PHARMA to INC in
writing, |
| ii. | take
all required steps and cooperate with PHARMA to put such assignment and transfer into effect, |
| iii. | except
as agreed under Section 13.5. and to the extent INC is required by applicable law to retain
any such documentation, upon request by and at the option of PHARMA, immediately either destroy
or return to PHARMA all documentation, in particular containing development data, reports
and regulatory filing documentation, whether in written form or stored in other media, and |
| iv. | provide
to PHARMA all information on historical sales and marketing efforts and revenues with respect
to the Product. |
| 17.3. | Accrued
Payment Claims. Termination of this Agreement for any reason whatsoever shall not relieve
INC of its obligations to pay all amounts payable to PHARMA which have accrued prior to,
but remain unpaid as of, the date of expiration or termination hereof, or which accrue thereafter. |
| 17.4. | Continued
Rights and Obligations of PHARMA. Except as otherwise specifically provided in this Agreement,
upon expiration or termination of this Agreement for any reason whatsoever, PHARMA shall
have no further obligations to INC hereunder. |
| 17.5. | Continued
Rights and Obligations of INC. Except as otherwise specifically provided in this Agreement,
upon expiration or termination of this Agreement for any reason whatsoever, INC shall have
no further obligations to PHARMA hereunder. |
| 18.1. | Assignment.
Subject to the other terms of this Agreement, no Party shall have the right or the power
to assign this Agreement or any of its rights or obligations under this Agreement, without
the prior written authorization of all other Parties; provided, however, that the prior written
authorization of PHARMA and/or BIOSCIENCE shall not be required should INC, in its reasonable
judgment, believe that it is necessary to assign this Agreement to an Affiliate or grant
a sub-license under this Agreement, e.g. for the purpose of a co-promotion of the Product
in the Territory in order to maximize its value to the Parties. Any permitted assignment
hereunder, whether to an Affiliate pursuant to this Section 18.1. or pursuant to the prior
written authorization of the other Parties, will (i) only become effective if the assigning
Party has notified the other Parties in writing at least 30 (thirty) days prior to the intended
assignment, and (ii) not relieve the assigning Party of any of its obligations under this
Agreement, including, but not limited to, the Party’s obligation to make outstanding
payments. |
| 18.2. | Force
Majeure. Unless provided otherwise in this Agreement, neither Party shall be liable for
any failure to perform, or any delay in the performance of, any of its obligations under
this Agreement to the extent that such Party’s performance is prevented by the occurrence
of an event of force majeure. For purposes of this Section 18.2., an event of force majeure
shall mean and include, war, civil war, insurrection, rebellion, civil unrest, fire, flood,
earthquake, adverse weather conditions, strike, lockout, labor unrest, unavailability of
supplies, materials or transportation, acts of the public enemy, acts of government authorities
and, in general, any other cause or condition beyond the reasonable control of the Party
whose performance is affected thereby. In the event that a Party’s performance is affected
by the occurrence of any event of force majeure, that Party shall furnish immediate written
notice thereof to the other Party hereto. |
| 18.3. | Notices.
All notices, reports and other communications between the Parties under this Agreement
shall be sent by registered mail, postage prepaid and return receipt requested, or by facsimile,
with a confirmation copy sent by registered mail or courier, addressed as indicated in the
introduction to this Amendment, with attention directed as follows: |
|
For
PHARMA: |
|
Attn.
General Manager / Geschaeftsfuehrer |
|
|
|
|
|
For
BIOSCIENCE: |
|
Attn.
General Manager / Geschaeftsfuehrer |
|
|
|
|
|
For
INC: |
|
Attn.
CEO; cc: Legal Department |
| 18.4. | Governing
Law; Jurisdiction and Venue. This Agreement shall be governed by and interpreted in accordance
with the laws of State of Delaware, USA without reference to conflicts of laws principles.
The Convention of International Sales of Goods shall not apply. The validity of any intellectual
property rights shall be subject to an evaluation under the law of the country in which the
intellectual property rights were applied for or have been issued. |
The
Parties hereto submit to the exclusive jurisdiction of the Court of Chancery of the State of Delaware or, if such Court does not have
subject matter jurisdiction, to the Superior Court of the State of Delaware or, if jurisdiction is vested exclusively in the Federal
courts of the United States, the Federal courts of the United States sitting in the State of Delaware, and any appellate court from any
such state or Federal court, and hereby irrevocably and unconditionally agree that all claims with respect to any such claim shall be
heard and determined in such Delaware court or, to the extent required by applicable Law, in such Federal court. The Parties agree that
a final judgment in any such claim is conclusive and may be enforced in any other jurisdiction by suit on the judgment or in any other
manner provided by law. Each of the Parties irrevocably and unconditionally waives, to the fullest extent it may legally and effectively
do so, any objection which it may now or hereafter have to the laying of venue of any suit, action or proceeding arising out of or relating
to this Agreement or any related matter in any Delaware state or Federal court located in the State of Delaware and the defense of an
inconvenient forum to the maintenance of such claim in any such court.
| 18.5. | Dispute
Resolution. As of the Effective Date, the Parties are unable to foresee all eventualities
resulting from future scientific, technical, economic and regulatory developments, possible
changes in legislation and/or the practical approach of Regulatory Authorities and/or governmental
authorities responsible for the reimbursement of the Products. Therefore, if any such aforementioned,
unforeseeable developments and/or changes beyond the reasonable control of the Parties should
materially affect the commercial basis of this Agreement as reflected therein and contemplated
by the Parties, the Parties agree to discuss such developments and changes in good faith
in order to reach agreement on an adequate and reasonable amendment of the relevant provisions
of this Agreement. |
Notwithstanding
the above, nothing in this Section 18.5 shall be interpreted to prohibit either Party from seeking immediate, temporary, or interim equitable
relief, including but not limited to injunctive relief or specific performance, if the opposing Party has committed, or has threatened
to commit, a material breach of this Agreement that will cause irreparable harm to the non-breaching Party.
| 18.6. | In
the event of any dispute arising out of or in connection with this Agreement, the Parties
agree to try to solve such dispute amicably first by a discussion of both Parties ‘
chief executive officers. For this purpose, the Party raising such a dispute shall notify
the other Party in writing and in reasonable detail about such dispute. In the event that
the senior management representatives of the Parties are not able to solve the dispute within
thirty (30) business days following receipt of the aforementioned dispute notice by the Party
to be notified, the Parties shall conduct a mediation procedure pursuant to 10 Del. C. §
347 and Rules 93 to 95 (the “Mediation Only Program”) or Delaware Court of Chancery
Rule 174. Place of the mediation proceedings shall be Boston, Massachusetts. The number of
mediators is one (1). The language of the mediation proceeding is English. If the dispute
has not been settled pursuant to the said rules within sixty (60) days following the filing
of a request for mediation or within such other period as the Parties may agree in writing,
either Party may submit the dispute to final and binding arbitration. |
Notwithstanding
the above, nothing in this Section 18.6 shall be interpreted to prohibit either Party from seeking immediate, temporary, or interim equitable
relief, including but not limited to injunctive relief or specific performance, if the opposing Party has committed, or has threatened
to commit, a material breach of this Agreement that will cause irreparable harm to the non-breaching Party.
| 18.7. | Any
dispute relating to the validity, performance, construction or interpretation of this Agreement,
which cannot be resolved amicably between the Parties, shall be finally determined by arbitration
in accordance with the International Arbitration Rules of the American Arbitration Association.
The decision of the arbitrators shall file final and binding upon the Parties and enforceable
in any court of competent jurisdiction. The place of arbitration shall be Boston Massachusetts.
The number of arbitrators is three (3). The language of the arbitration proceeding is English.
Notwithstanding the above, nothing in this Section 18.7 shall be interpreted to prohibit
either Party from seeking immediate, temporary, or interim equitable relief, including but
not limited to injunctive relief or specific performance, if the opposing Party has committed,
or has threatened to commit, a material breach of this Agreement that will cause irreparable
harm to the non-breaching Party. |
| 18.8. | Severability.
If any provision of this Agreement is determined by any court or administrative tribunal
of competent jurisdiction to be invalid or unenforceable, the Parties shall negotiate in
good faith a replacement provision that is commercially equivalent, to the maximum extent
permitted by applicable law, to such invalid or unenforceable provision. Unless otherwise
provided in this Agreement the invalidity or unenforceability of any provision of this Agreement
shall not affect the validity or enforceability of the other provisions of this Agreement. |
| 18.9. | Entire
Agreement and Amendments. This Agreement, together with all Exhibits attached hereto,
constitutes the entire agreement between the Parties, and supersedes all prior agreements,
understandings and communications between the Parties, with respect to the subject matter
hereof. No modification or amendment of this Agreement shall be binding upon the Parties
unless in writing and executed by the duly authorized representative of each of the Parties;
this shall also apply to any change of this clause. |
| 18.10. | Waivers.
The failure by either Party hereto to assert any of its rights hereunder, including,
but not limited to, the right to terminate this Agreement due to a breach or default by the
other Party hereto, shall not be deemed to constitute a waiver by that Party of its right
thereafter to enforce each and every provision of this Agreement in accordance with its terms. |
| 18.11. | Press
Releases. INC give notice to PHARMA prior to issuing any press release relating to this
Agreement within due time to allow for reasonable consideration. The Party issuing the press
release shall give due consideration and weight to any comments or concerns raised by the
other Party. |
[Remainder
of page intentionally left blank; Signature page follows]
IN
WITNESS WHEREOF, the Parties have executed this Amended and Restated License and Supply Agreement as of the date first set forth above.
Biofrontera
Pharma GmbH |
|
Biofrontera Bioscience GmbH |
|
|
|
|
Name:
|
Pilar
de la Huerta |
|
Name:
|
Pilar
de la Huerta |
|
|
|
|
|
Title:
|
Managing
Director |
|
Title:
|
Managing
Director |
|
|
|
|
|
Signature:
|
/s/
Pilar de la Huerta |
|
Signature:
|
/s/
Pilar de la Huerta |
|
|
|
|
|
Date:
|
13/2/2024 |
|
Date:
|
13/2/2024 |
Biofrontera
Inc |
|
|
|
|
Name:
|
Hermann
Luebbert |
|
|
|
|
Title:
|
Chief
Executive Officer |
|
|
|
|
Signature:
|
/s/
Hermann Luebbert |
|
|
|
|
Date:
|
2/19/2024 |
|
EXHIBIT
A
Amended
and Restated License and Supply Agreement
Improvements
that are Currently in Development (Section 7.1(b))
Product |
|
Indication |
|
Study
type |
|
Anticipated
start of patient recruitment |
BF-RhodoLED®
XL |
|
PDT
lamp for illumination of larger body regions |
|
Not
applicable |
|
submitted
to FDA in Q2 2021 |
Ameluz® |
|
Actinic
keratosis |
|
Pharmacokinetics
study |
|
completed |
Ameluz® |
|
Superficial
basal cell carcinoma |
|
Phase
III |
|
ongoing |
Ameluz® |
|
Actinic
keratosis |
|
Phase
I safety study with 3 tubes of Ameluz® |
|
H2
2021 |
Ameluz® |
|
Moderate
to severe acne |
|
Phase
IIb |
|
H2
2021 |
Ameluz® |
|
Actinic
keratosis |
|
Phase
III on face and scalp with 3 tubes and pain-reducing illumination protocol |
|
2022 |
Ameluz® |
|
Actinic
keratosis |
|
Phase
III on trunk & extremities |
|
2022 |
Ameluz® |
|
Squamous
cell carcinoma in situ |
|
Phase
III |
|
2023 |
EXHIBIT
B
Transferrable
Contracts
1. | FGK
(Data Management and Statistics) |
4. | Rhenus
(Archiving Facility) |
5. | ACM
(Analytical lab; Safety lab; Pharmacovigilance) |
6. | Nuvisan
(Evaluation of pharmacovigilance results) |
7. | Individual
Investigator Contracts (various) |
8. | eClinPro
(Data source templates) |
9. | Patient
Insurance Costs |
10. | Office
lease, as needed based on transfer of Transferrable Personnel to INC |
Transferrable
Personnel
1. | Clinical
Trial Managers, including Senior Clinical Trial Managers (5 employees) |
2. | Medical
Writing (2 employees) |
3. | Senior
Quality Manager (1 employee) |
4. | GCP
Support (5 employees) |
EXHIBIT
RECITAL (C)
List
of Patents and Trademarks
1. | Patent
US 6,559,183 B1 granted in the USA describing the combination of 5-ALA and nanoemulsions. |
2. | Patent
application US 2009/0324727 Al pending in the USA describing the specific nanoemulsion used
in Ameluz®. |
3. | Trademark
“Biofrontera” (International registration no. 935601) registered in the USA. |
4. | Figurative
trademark “Biofrontera” (International registration no. 1075749) registered in
the USA. |
5. | Trademark
“Ameluz” (International registration no. 1031222) registered in the USA. |
6. | Trademarks
RHODOLED (International registration no. 1111189) and BF-RhodoLED (International registration
no. 1113422), registered in the USA. |
Addendum
to
Second
Amended and Restated License and Supply Agreement
This
Addendum to Second Amended and Restated License and Supply Agreement (the “Amended Addendum”) is made effective as of February
8, 2024, 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 a Second Amended and Restated License and Supply Agreement, dated as of February 8,
2024 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. [***] to PHARMA; |
| b. | INC’s
payment of Invoice No. [***] (as adjusted to reflect termination of IT services on
December 19, 2022) to PHARMA; |
| c. | INC’s
payment of Invoices No [***], [***], [***] to PHARMA; |
| d. | INC’s
payment of invoices No [***] and No. [***] (services issues) to BIOSCIENCE; |
| e. | BIOSCIENCE’s
payment of Invoice Nos. [***], [***], and [***] to INC; |
| f. | INC’s
payment of an invoice to be issued by PHARMA in relation to PO #[***] (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; |
| i. | INC’s
payments of invoices to be issued by PHARMA in relation to POs #[***], #[***],
and #[***]; 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. | If
not already paid, as soon as reasonably possible, INC will pay to PHARMA $2.791M towards
[***], [***], [***] and [***]. |
| i. | This
sum shall be reduced by any outstanding payments from BIOSCIENCE to INC under Invoice Nos.
[***], [***], and [***]. |
| b. | On
or before February 29, 2024, INC will pay to PHARMA i) the remainder owed under [***]
(approximately $1.4-1.6M), and ii) the full amount owed under the invoice to be issued
by PHARMA in relation to PO # [***] (estimated at approximately $[***]). |
| i. | In
not already done, the outstanding sum owed by INC to PHARMA under Section 2(b) above 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 and any outstanding payments from BIOSCIENCE to INC
in relation to clinical services provided to BIOSCIENCE in Q4 2023. Upon this reduction of
these amounts owed by INC to PHARMA, the payment obligations by AG and Bioscience to INC
referenced in this Section 2(b)(i) shall be deemed to be satisfied in full. |
| c. | On
or before February 29, 2024, INC will pay to AG invoice [***] and to Bioscience invoices
No [***] and No. [***]. |
| d. | On
each of the following dates, INC will pay to PHARMA one-third of the agreed upon 2023 PPV
and any invoices issued by PHARMA in relation to POs #[***], #[***], and #[***]:
April 30, 2024; May 31, 2024; June 30, 2024. |
| 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 #[***], #[***], and #[***]. |
| 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 INC fails 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
4.1(d) of the 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(e).
| 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 of the 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 Second Amended and Restated License and Supply Agreement as of the date first
set forth above.
BIOFRONTERA
AG |
BIOFRONTERA INC. |
|
|
|
|
BIOFRONTERA
PHARMA GmbH |
|
|
|
|
|
|
|
BIOFRONTERA
BIOSCIENCE 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:
|
13/2/24 |
|
Date: |
02/19/2024 |
Exhibit
10.2
Release
of Claims
This
Release of Claims (the “Agreement”) dated February 13, 2024 by and between Biofrontera Pharma GmbH, a German corporation
with its principal offices at Hemmelrather Weg 201, 51377 Leverkusen, Germany (“PHARMA”), Biofrontera Bioscience GmbH, a
German corporation with its principal offices at Hemmelrather Weg 201, 51377 Leverkusen, Germany (“BIOSCIENCE”) (collectively
the “Releasees”) and Biofrontera Inc., a Delaware corporation with its principal place of business at 120 Presidential Way,
Suite 330, Woburn, MA 01801, USA (“the Releasor”). The Releasor and the Releasees are referred to herein individually as
a Party and collectively as the Parties. This Agreement is effective as of the date it is signed by the last Party to sign it, as indicated
by the date next to such Party’s signature (“Effective Date”).
Recitals
Whereas,
the Parties have entered into a License and Supply Agreement, dated as of October 1, 2016, which was amended as of i) July 01, 2019 (with
said amendment erroneously referring to the LSA’s effective date as July 15, 2016), ii) June 16, 2021, iii) October 8, 2021 (with
said amendment correcting a previous version signed on the amendment’s effective date), iv) December 5, 2023, and v) January 26,
2024 (collectively, the “LSA”);
Whereas,
pursuant to Section 7.1(c) of the LSA (in part):
“PHARMA
and BIOSCIENCE have the obligation to continue to pursue, in good faith, all Improvements that are currently in development by PHARMA
and/or BIOSCIENCE in a timely manner at their own cost for the improvement of the US label of the Licensed Product(s) in order to fully
exploit the market potential of such Product(s).”
Whereas,
the “Improvements that are currently in development” referenced in Section 7.1(c) of the LSA are as follows:
Product |
|
Indication |
|
Study
Type |
|
Anticipated
start of patient recruitment |
BF-RholoLED®
XL |
|
PDT
lamp for illumination of larger body regions |
|
Not
applicable |
|
submitted
to FDA in Q2 2021 |
Ameluz® |
|
Actinic
keratosis |
|
Pharmacokinetics
study |
|
completed |
Ameluz® |
|
Superficial
basal cell carcinoma |
|
Phase
III |
|
ongoing |
Ameluz® |
|
Actinic
keratosis |
|
Phase
I safety study with 3 tubes of Ameluz |
|
H2
2021 |
Ameluz® |
|
Moderate
to severe acne |
|
Phase
IIb |
|
H2
2021 |
Ameluz® |
|
Actinic
keratosis |
|
Phase
III on face and scalp with 3 tubes and pain reducing illumination protocol |
|
2022 |
Ameluz® |
|
Actinic
keratosis |
|
Phase
III on trunk & extremeties |
|
2022 |
Ameluz® |
|
Squamous
cell carcinoma in situ |
|
Phase
III |
|
2023 |
Whereas,
Releasees’ failure to pursue the “Improvements that are currently in development” in a timely manner and otherwise
in compliance with Section 7.1(c) of the LSA could give rise to valuable legal claims for damages by Releasor;
Whereas,
contemporaneously with the execution of the Agreement, the Parties have agreed to further amend the LSA to, in part, i) relieve Releasees
of certain obligations with respect to clinical trials and the pursuit of (“Trial Obligations”), and ii) transfer the “Improvements
that are currently in development” from Releasees to Releasor (the “LSA Amendment”); and
Whereas,
in conjunction with the LSA Amendment, the Parties have agreed that Releasor shall relinquish certain legal rights under the LSA with
respect to the Trial Obligations, as described in more detail below.
Now,
therefore, in consideration of the mutual covenants and promises contained herein, and other good and valuable consideration, the receipt
and sufficiency of which are hereby acknowledged, and intending to be legally bound, the Parties hereto agree as follows:
AGREEMENT
1.1. Releasor
does hereby release, cancel, and forever discharge the Releasees and their directors, officers, employees, subsidiaries, affiliates,
agents, and representatives from any and all claims, complaints, causes of action, demands, damages, obligations, liabilities, losses,
promises, agreements, controversies, penalties, expenses, and executions of any kind or nature whatsoever, whether known or unknown,
actual or potential, whether arising in law or in equity, which Releasor may have, may have had, or may in the future obtain, arising
out of or relating out of any failure by Releasees to perform the Trial Obligations in accordance with the Section 7.1(c) of the LSA
(the “Released Claims”) (in total, the “Release”).
1.2. Each
Party represents and warrants that it has not filed any action or initiated any other proceeding with any court or government authority
against or involving the other Party that may constitute a claim or provide the basis for any liability based on facts in any way relating
to those pertinent to the Released Claims.
2.1. The
Releasor acknowledges and agrees that, upon execution of the LSA Amendment by Releasees, it will have received good, valuable and sufficient
consideration for making this Release.
3.1. This
Release is intended to be a general release of the Released Claims by Releasors. It is understood and agreed that the Parties hereby
expressly waive any and all laws and statutes, of all jurisdictions whatsoever, which may provide that a general release does not extend
to claims not known or suspected to exist at the time of executing a release which if known would have materially affected the decision
to give the Release. It is expressly intended and agreed that the Release does, in fact, extend to such unknown and unsuspected claims
related to anything which has happened to the date hereof which is covered by this Release, even if knowledge thereof would have materially
affected the decision to give this Release. In addition, the Parties warrant and represent to the other that the execution and delivery
of this Release does not, and with the passage of time will not, violate any obligation of the Party to any third party. Each Party further
represents and warrants that it has not assigned any of its rights with respect to the LSA to any other party.
4.1. The
Parties expressly agree and acknowledge that this Release represents the settlement and compromise of potential disputed claims, and
that by entering into this Agreement neither Party hereto admits or acknowledges the existence of any liability, obligation, or wrongdoing
on its part. Each Party expressly denies any and all liability with respect to the subject matter of this Agreement.
5. | Independent
Legal Counsel. |
5.1. The
Parties acknowledge that they have had the opportunity to consult with independent legal counsel regarding the legal effect of this Agreement
and the Release. Each Party enters into this Agreement freely and voluntarily.
| 6.1. | Governing
Law; Venue. This Agreement shall be governed by and construed in accordance with the
laws of the State of Delaware, notwithstanding its choice of law provisions. The Parties
agree that any claims or legal actions by one Party against the other to enforce the terms
of this Agreement or concerning any rights under this Agreement shall be commenced and maintained
in the Court of Chancery of the State of Delaware or, if such Court does not have subject
matter jurisdiction, to the Superior Court of the State of Delaware or, if jurisdiction is
vested exclusively in the Federal courts of the United States, the Federal courts of the
United States sitting in the State of Delaware. |
| 6.2. | Fees
and Expenses. Each Party hereto shall bear its own fees and expenses (including attorneys’
fees) incurred in connection with this Agreement and the consummation of the transactions
contemplated hereby. If either Party incurs any legal fees and/or costs and expenses in any
proceeding to enforce the terms of this Agreement or any of its rights provided hereunder,
the prevailing Party shall be entitled to recover its reasonable attorneys’ fees and
any court, arbitration, mediation, or other litigation expenses from the other Party. |
| 6.3. | Counterparts.
This Agreement may be executed in one or more counterparts, each of which will be deemed
to be an original, but all of which together will constitute one and the same instrument,
without necessity of production of the others. An executed signature page delivered via facsimile
transmission or electronic signature shall be deemed as effective as an original executed
signature page. |
| 6.4. | Waiver.
No waiver of any term or right in this Agreement shall be effective unless in writing, signed
by an authorized representative of the waiving Party. The failure of either Party to enforce
any provision of this Agreement shall not be construed as a waiver or modification of such
provision, or impairment of its right to enforce such provision or any other provision of
this Agreement thereafter. |
| 6.5. | Entire
Agreement. This Agreement sets forth the entire and complete understanding and agreement
between the Parties regarding the Released Claims. This Agreement supersedes any and all
other prior agreements or discussions, whether oral, written, electronic or otherwise, relating
to the Released Claims. Any additions or modifications to this Agreement must be made in
writing and signed by authorized representatives of both Parties. The Parties acknowledge
and agree that they are not relying upon any representations or statements made by the other
Party or the other Party’s employees, agents, representatives or attorneys regarding
this Agreement, except to the extent such representations are expressly set forth herein. |
| 6.6. | Authority.
By signing below the Parties represent that the signatories are authorized to execute this
Agreement on behalf of their respective business entities and that the execution and delivery
of this Agreement are the duly authorized and binding acts of their respective corporations. |
[Remainder
of page intentionally left blank; Signature page follows]
IN
WITNESS WHEREOF, the Parties have executed this Waiver of Claims as of the last date set forth below.
Biofrontera
Pharma GmbH |
|
Biofrontera Bioscience GmbH |
|
|
|
|
Name:
|
Pilar
de la Huerta |
|
Name:
|
Pilar
de la Huerta |
|
|
|
|
|
|
|
|
|
Title:
|
Managing
Director |
|
Title:
|
Managing
Director |
|
|
|
|
|
|
|
|
|
Signature:
|
/s/
Pilar de la Huerta |
|
Signature:
|
/s/
Pilar de la Huerta |
|
|
|
|
|
|
|
|
|
Date:
|
February
13, 2024 |
|
Date:
|
February
13, 2024 |
|
|
|
|
Biofrontera
Inc |
|
|
|
|
Name:
|
Hermann
Luebbert |
|
|
|
|
Title:
|
Chief
Executive Officer |
|
|
|
|
Signature:
|
/s/
Hermann Luebbert |
|
|
|
|
Date:
|
February
13, 2024 |
|
Exhibit 99.1
Biofrontera
Inc. Announces Restructuring of Supply Agreement with Biofrontera AG
| Ø | Ameluz®
transfer price to Biofrontera AG reduced significantly |
| Ø | Control
of all US clinical trials of Ameluz transfers to Biofrontera Inc. on June 1 |
WOBURN,
MA / ACCESSWIRE / February 20, 2024 / Biofrontera Inc. (NASDAQ:BFRI) (“Biofrontera” or the “Company”),
a biopharmaceutical company specializing in the commercialization of dermatologic products, today announced the restructuring of agreements
between the Company and its former parent company Biofrontera AG. With immediate effect, the transfer price of Ameluz®
will be reduced from 50% to 25% for all purchases in 2024 and 2025.
Starting
on January 1, 2026, until 2032 there will be step-wise increases in the transfer price from 25% to 35% for sales related to actinic
keratosis and, if approved by the FDA, basal cell carcinoma and squamous cell carcinoma. The transfer price for sales related to acne,
another indication currently in development, will remain at 25% indefinitely. The transfer price covers the cost of goods, royalties
on sales, and services including all regulatory efforts, agency fees, pharmacovigilance, and patent administration.
Additionally,
effective June 1, the Company will take control of all clinical trials with Ameluz® in the US, allowing for more effective cost management
and direct oversight of trial efficiency. The reduced LSA transfer price will allow the Company to finance such R&D activities
and continue our commercial growth trajectory.
“This
amendment provides significant value in both the short and long term. In the short term, we will be paying half of what we had paid in
the past for product. In the long term, controlling US clinical trials will enable us to better manage costs and ensure efficiency,
which we believe will lead to new indications in the label and increased revenue sooner,” stated Hermann Luebbert,
Chief Executive Officer and Chairman of Biofrontera Inc.
“We
believe that the renegotiated terms along with the capital committed in our simultaneous financing accelerate and could be sufficient
for the company achieving profitability in 2025. This will be further supported by the potential label change of Ameluz for the use of
up to three tubes per treatment currently under review by the FDA with a user fee goal of October 4, 2024” he continued.
This
press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor
shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful
prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
For
further information, please see the Company’s current report on Form 8-K to be filed with the SEC.
About
Actinic Keratosis
Actinic
keratosis (AK) is the most common pre-cancerous skin lesion caused by chronic sun exposure that may, if left untreated, develop into
life-threatening skin cancer called squamous cell carcinoma. AKs typically appear on sun-exposed areas such as the face, bald scalp,
arms or the back of the hands. In 2020 approximately 58 million people in the US were affected by AK and 13 million AK treatments were
performed.3
AboutBiofrontera
Inc.
Biofrontera
Inc. is a U.S.-based biopharmaceutical company commercializing a portfolio of products for the treatment of dermatologic conditions with
a focus on photodynamic therapy (PDT) and topical antibiotics. The Company’s licensed products are used for the treatment of actinic
keratoses, which are pre-cancerous skin lesions, as well as impetigo, a bacterial skin infection. For more information, visit www.biofrontera-us.com
and follow Biofrontera on LinkedIn and Twitter.
Forward-Looking
Statements
Certain
statements in this press release may constitute “forward-looking statements” within the meaning of the United States Private
Securities Litigation Reform Act of 1995, as amended to date. These statements include, but are not limited to, statements relating to
the clinical development strategy for Ameluz®, changes to the purchase price of the Company’s licensed products, the potential
to expand the label of Ameluz®, ongoing clinical trials conducted in collaboration with our licensing partner, and the
future impact of such trials on the market for Ameluz®. We have based these forward-looking statements on our current
expectations and projections about future events, nevertheless, actual results or events could differ materially from the plans, intentions
and expectations disclosed in, or implied by, the forward-looking statements we make. These risks and uncertainties, many of which are
beyond our control, including, but not limited to, the impact of any extraordinary external events; any changes in the Company’s
relationship with its licensors; the ability of the Company’s licensors to fulfill their obligations to the Company in a timely
manner; the Company’s ability to achieve and sustain profitability; whether the current global disruptions in supply chains will
impact the Company’s ability to obtain and distribute its licensed products; changes in the practices of healthcare providers,
including any changes to the coverage, reimbursement and pricing for procedures using the Company’s licensed products; the uncertainties
inherent in the initiation and conduct of clinical trials; availability and timing of data from clinical trials; whether results of earlier
clinical trials or trials of Ameluz® in combination with BF-RhodoLED® in different disease indications
or product applications will be indicative of the results of ongoing or future trials; uncertainties associated with regulatory review
of clinical trials and applications for marketing approvals; whether the market opportunity for Ameluz® in combination
with BF- RhodoLED® is consistent with the Company’s expectations; the Company’s ability to comply with public
company requirements; the Company’s ability to retain and hire key personnel; the sufficiency of cash resources and need for additional
financing and other factors that may be disclosed in the Company’s filings with the SEC, which can be obtained on the SEC website
at www.sec.gov. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date
on which they are made and reflect management’s current estimates, projections, expectations and beliefs. The Company does not
plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press
release except as required by law.
Contact:
Barwicki
Investor Relations
Andrew Barwicki
1-516-662-9461
ir@bfri.com
SOURCE:
Biofrontera Inc.
View
the original press release on accesswire.com
Exhibit 99.2
Biofrontera
Inc. Announces Private Placement of Up To $16.0 Million
| Ø | Company
secures financing of $8 million with an additional $8 million second tranche
tied to milestones for aggregate proceeds of $16 million gross priced at market
per Nasdaq rules |
| Ø | Funding
and recent restructuring of supply agreement allow Biofrontera Inc to assume R&D activities
and to support further commercial growth |
WOBURN,
MA / ACCESSWIRE / February 20, 2024 / Biofrontera Inc. (NASDAQ:BFRI) (“Biofrontera” or the “Company”),
a biopharmaceutical company specializing in the commercialization of dermatologic products, today announced it has entered into a securities
purchase agreement with healthcare-focused institutional investors led by Rosalind Advisors. Pursuant
to the securities purchase agreements, the Company will issue to the purchasers (a) an aggregate $8.0 million in shares of the
company’s Series B-1 Convertible Preferred Stock and (b) warrants to purchase shares of the Company’s Series B-3 Convertible
Preferred Stock with an aggregate exercise price of $8.0 million exercisable until the earlier of (i) five days after achievement
of certain operational and commercial milestones, expected in Q2 of 2024, the approval by the Company’s shareholders of an increase
in authorized shares and other proposals, and the effectiveness of a registration statement with the U.S. Securities and Exchange
Commission covering the resale of the Common Stock underlying all shares of preferred stock that may be issued under the securities
purchase agreement or (ii) the five-year anniversary of the issuance of the warrants.
Shares
of Series B-1 and Series B-3 Convertible Preferred Stock will be issued at a price of $1,000.00 per share. Conversion of all of the
shares of Series B-3 Convertible Preferred Stock into shares of common stock of the Company is subject to approval by the
Company’s stockholders of an increase in the Company’s authorized shares of common stock. The shares of Series B
-1 Convertible Preferred Stock convert into 9,310,677 shares of common stock at a conversion price of $0.7074. The
shares of Series B -3 Convertible Preferred Stock to be issued upon exercise of all of the warrants convert into 11,309,019 shares
of common stock (disregarding any conversion or beneficial ownership limitations) at a conversion price of $0.7074. The consideration for each warrant is $0.125 per share of common stock that each share of Series B-3 Convertible
Preferred Stock may be converted into.
Biofrontera
anticipates that aggregate gross proceeds will be up to $16 million, if all warrants are exercised, before deducting fees to the
placement agents and other estimated offering expenses payable by the Company. This private placement is expected to close on or about
February 21, 2024, subject to customary closing conditions.
The
Company agreed to appoint up to two directors nominated by the lead investor to the board of directors of the Company.
The
Company intends to use the upfront net proceeds from the private placement to fund the Company’s general business operations and
ongoing activities related to expediting the development and approval of additional indications for the Company’s lead product
Ameluz. The product is currently approved in conjunction with the BF-RhodoLED lamp series for the treatment of mild to moderate actinic
keratosis on the face and scalp (AK).
The
securities to be issued in connection with the private placement described above are being offered in a private placement under Section
4(a)(2) of the Securities Act of 1933 and Regulation D promulgated thereunder and have not been registered under the Act or applicable
state securities laws. Accordingly, such securities may not be offered or sold in the United States except pursuant to an effective registration
statement or an applicable exemption from the registration requirements of the Securities Act of 1933 and such applicable state securities
laws. The Company has agreed to file a resale registration statement with the U.S. Securities and Exchange Commission (SEC), for purposes
of registering the resale of the common stock issued or issuable in connection with the private placement.
This
press release shall not constitute an offer to sell or a solicitation of an offer to buy any of the securities described herein, nor
shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful
prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
For
further information, please see the Company’s current report on Form 8-K to be filed with the SEC following the closing of the
transaction.
About
Actinic Keratosis
Actinic
keratosis (AK) is the most common pre-cancerous skin lesion caused by chronic sun exposure that may, if left untreated, develop into
life-threatening skin cancer called squamous cell carcinoma. AKs typically appear on sun-exposed areas such as the face, bald scalp,
arms or the back of the hands. In 2020 approximately 58 million people in the US were affected by AK and 13 million AK treatments were
performed.3
About
Biofrontera Inc.
Biofrontera
Inc. is a U.S.-based biopharmaceutical company commercializing a portfolio of products for the treatment of dermatologic conditions with
a focus on photodynamic therapy (PDT) and topical antibiotics. The Company’s licensed products are used for the treatment of actinic
keratoses, which are pre-cancerous skin lesions, as well as impetigo, a bacterial skin infection. For more information, visit www.biofrontera-us.com
and follow Biofrontera on LinkedIn and Twitter.
Forward-Looking
Statements
Certain
statements in this press release may constitute “forward-looking statements” within the meaning of the United States Private
Securities Litigation Reform Act of 1995, as amended to date. These statements include, but are not limited to, statements relating to
the closing of the described private placement of securities. We have based these forward-looking statements on our current expectations
and projections about future events, nevertheless, actual results or events could differ materially from the plans, intentions and expectations
disclosed in, or implied by, the forward-looking statements we make. These risks and uncertainties, many of which are beyond our control,
including, but not limited to, the impact of any extraordinary external events; any changes in the Company’s relationship with
its licensors; the ability of the Company’s licensors to fulfill their obligations to the Company in a timely manner; the Company’s
ability to achieve and sustain profitability; whether the current global disruptions in supply chains will impact the Company’s
ability to obtain and distribute its licensed products; changes in the practices of healthcare providers, including any changes to the
coverage, reimbursement and pricing for procedures using the Company’s licensed products; the uncertainties inherent in the initiation
and conduct of clinical trials; availability and timing of data from clinical trials; whether results of earlier clinical trials or trials
of Ameluz® in combination with BF-RhodoLED® in different disease indications or product applications will
be indicative of the results of ongoing or future trials; uncertainties associated with regulatory review of clinical trials and applications
for marketing approvals; whether the market opportunity for Ameluz® in combination with BF- RhodoLED® is
consistent with the Company’s expectations; the Company’s ability to comply with public company requirements; the Company’s
ability to retain and hire key personnel; the sufficiency of cash resources and need for additional financing and other factors that
may be disclosed in the Company’s filings with the SEC, which can be obtained on the SEC website at www.sec.gov. Readers are cautioned
not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management’s
current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and
expressly disclaims any duty to update the information contained in this press release except as required by law.
Contact:
Barwicki
Investor Relations
Andrew Barwicki
1-516-662-9461
ir@bfri.com
SOURCE:
Biofrontera Inc.
View
the original press release on accesswire.com
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