Exhibit
10.1


 


Amended
and Restated License and Supply Agreement


 


This
Amended and Restated License and Supply Agreement (the “Amendment”) is made effective as of June 16, 2021, 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.


 


Amendment
Recitals


 


Whereas,
the Parties have entered into a License and Supply Agreement, dated as of October 1, 2016, which was first amended as of July
01, 2019 (with said first amendment erroneously referring to the LSA’s effective date as July 15, 2016) (collectively, the
“LSA”);


 


Whereas,
the LSA is based on a mutual understanding that is not in every respect detailed in the Agreement; and


 


Whereas,
the Parties wish to modify or specify the respective aspects of the LSA, including but not limited to the inclusion of BIOSCIENCE
as a Party to the LSA.


 


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
    is a subsidiary of Biofrontera AG, Hemmelrather Weg 201, 51377 Leverkusen, Germany. The Biofrontera group, currently consisting
    of Biofrontera AG and its wholly- owned US subsidiary INC and German subsidiaries PHARMA, Biofrontera Bioscience GmbH, Biofrontera
    Development GmbH and Biofrontera Neuroscience GmbH, 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. Biofrontera
    Bioscience GmbH is, within Biofrontera group, responsible for drug development and registration and the holder of the group’s
    medicinal product approvals. PHARMA is responsible for 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”.


 




    	 



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	(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”.
    Biofrontera Bioscience GmbH 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, medical devices and medical cosmetics.
	 	 
	(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


 


	1.	DEFINITIONS.


 


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.


 




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		1.5.	“PHARMA
    Technology” shall mean the PHARMA Patent Rights 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 the twelve (12) months period each year following the first day of the calendar month (or the anniversary,
    respectively) 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.


 




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	 	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.	“lmprovement(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).


 




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	 	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.


 




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	 	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 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, 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.


 




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	 	 	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.	INC’S
    OBLIGATIONS.


 


	 	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.


 




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	 	3.2.	Anticipated
    Sales. The Parties envisage the sales of the Product units as shown in Exhibit 3.2 hereto.
	 	 	 
	 	3.3.	Minimum
    Sales. For four (4) Commercial Years, following First Commercial Sale, INC agrees to sell a minimum of [***] percent
    ([***]%) of the aggregate units of the Licensed Product as shown in Exhibit 3.2 (the “Annual
    Minimum Sales”). 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, and these changes have a negative impact on the market receptivity
    for the Licensed Product on the respective Annual Minimum Sales according to the respective binding supply agreement, the
    Parties shall in good faith discuss an appropriate amendment of the Annual Minimum Sales for the respective country.
	 	 	 
	 	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 [***] 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 [***] 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.


 




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	 	 	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 [***] 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 an 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.


 


	4.	PAYMENT
    TERMS.


 


	 	4.1.	Payment
    Terms.


 


	 	 	a.	All
    payments due to PHARMA or BIOSCIENCE shall be made by INC by bank transfer to the following account of PHARMA:


 


Volksbank
Rhein-Wupper e.G.


 


SWIFT
GENODEDlRWL


 


IBAN:
DE05 3756 0092 1000 1730 17


 


	 	 	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.


 




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	 	 	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.


 




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	6.	PRICE
    AND PAYMENT.
	 	 	 
	 	6.1.	Payment
    due to PHARMA for the Licensed Products and the Lamps shall be made by INC no later than [***] 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 fifty percent (50%) of the “Anticipated Net Price
    Per Unit”, i.e. the gross price INC or its Affiliates, respectively, are reasonably anticipating, from time to time, 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 (the “INC Ex Works Price”) less any allowable deductions as detailed under
    the definition of Net Sales (the “Deductions”). In any event, the Transfer Price shall not be less than [***]
    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.	The
    INC Ex Works Price applicable for the Commercial Year following the First Commercial Sale shall be proposed in writing by
    INC based on INC’s reasonable anticipation of the achievable net sales price per unit of Product during the Commercial
    Year following First Commercial Sale. For the second 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 [***] 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;


 




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	 	 	c.	the
    Actual Sales Units;
	 	 	 	 
	 	 	d.	any
    Deductions;
	 	 	 	 
	 	 	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 [***] 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 [***] 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.	IMPROVEMENTS.
	 	 	 	 
	 	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 develops any Improvements with respect to the use of Licensed Products in the Field,
    PHARMA will, and hereby does, grant INC an exclusive, royalty-free, fully paid-up license in the Field and in the Territory
    to use such Improvements during the Term.


 




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	 	 	c.	PHARMA
    and BIOSCIENCE have the obligation to undertake clinical development 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). If INC reasonably
    demonstrates that a specific improvement of the label will be mutually beneficial for the future sales of the Product(s),
    thereby taking the cost of the trial into consideration, and PHARMA or BIOSCIENCE nevertheless refuse to perform or finance
    the necessary clinical trials at their own cost, then INC has, irrespective of Section 10.10, the right to organize and finance
    such trials, and subtract the cost from the Transfer Price at future shipments. Any such subtractions cannot reduce the transfer
    price to less than [***] of its normal value. If the Parties fail to agree on the mutual benefit of a particular clinical
    trial, then an independent expert will be agreed upon whose opinion will be binding for the Parties.
	 	 	 	 
	 	7.2.	Improvements
    by INC.
	 	 	 	 
	 	 	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. The
    foregoing also applies to any share of PHARMA or BIOSCIENCE in such Improvements to the extent that INC has, jointly with
    PHARMA or BIOSCIENCE, contributed to the development of the respective Improvement.
	 	 	 	 
	 	 	b.	In
    the event that, during the Term, INC develops any Improvements with respect to the use of Licensed Products in the Field,
    INC shall furnish PHARMA and BIOSCIENCE with timely written notice of such Improvements, and INC will, and hereby does, grant
    PHARMA and BIOSCIENCE a perpetual, worldwide, sub-licensable, royalty free license to use all such Improvements and all information,
    know-how and other data pertaining to such Improvements. Such license will be exclusive for any use in the Field, and non-exclusive
    outside the Field.
	 	 	 	 
	 	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.
	 	 	 	 
	 	 	b.	In
    the event that during the Term, BIOSCIENCE develops any Improvements with respect to the use of Licensed Products in the Field,
    BIOSCIENCE will, and hereby does, grant INC an exclusive, royalty-free, fully paid-up license in the Field and in the Territory
    to use such Improvements during the Term.


 




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	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 [***] 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 disputes 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.


 




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	 	 	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) [***] days of the date of notice of such infringement, or (ii) [***] 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.


 




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	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 of the CDA and/or during the continuance of
    the Term shall be the joint property of INC and PHARMA each of whom shall have a share corresponding to the relative contributions
    to the respective invention. 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. Unless agreed otherwise, the Parties will bear the costs
    of such filing, prosecution and maintenance of Joint Patent Rights according to their share in the property of the underlying
    invention. In making such a decision, the principles observed by the Parties will be the relative contributions of each Party
    to the joint invention, the standards and customs in the industry and expected efficiency in patenting procedures.
	 	 	 
	 	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, [***]
    days, but in any event not less than [***] 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.


 




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	10.	REGULATORY
	 	 	 
	 	10.1.	PHARMA
    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 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 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, render BIOSCIENCE, or, at the request of BIOSCIENCE, PHARMA, 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.


 




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	 	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.	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 from [***]% to [***]% of net sales.


 


	11.	RECALL
	 	 	 	 	 
	 	11.1.	The
    Parties shall:
	 	 	 	 	 
	 	 	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.


 




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	 	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 [***] working days of actual receipt, any or all of a shipment of Product and, within [***]
    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.


 




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	 	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.	CONFIDENTIALITY.
	 	 	 
	 	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 [***] 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 [***] 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.


 




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 	 	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 non-disclosure 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, 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
    [***] 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.


 




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	 	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 [***] 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, owns 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;


 




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	 	 	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 [***] 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.


 




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	 	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 [***] 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 [***] 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.


 




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	16.	TERM
    AND TERMINATION.
	 	 	 
	 	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 commercialize of the Licensed Products, 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, 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 Non-
    Breaching 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.
	 	 	 
	 	 	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 (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 is 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.


 




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	 	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 by PHARMA for Non-Fulfillment. PHARMA shall be entitled to, by written notice to INC, terminate the License
    if INC should, during two (2) consecutive Commercial Years, (i) not achieve the Annual Minimum Sales according to Section
    3.3., and (ii) does not make up such shortfall by either purchasing and paying the deficient units of Licensed Product, or
    by paying PHARMA the purchase price of the deficient units of Licensed Product based on the applicable Transfer Price, in
    each case during the first [***] business days of the Commercial Year following the Commercial Year during which the
    shortfall occurred.
	 	 	 
	 	16.6.	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 [***] days prior written
    notice to PHARMA, terminate this Agreement.
	 	 	 
	 	16.7.	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 [***] 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 [***] 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


 




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	 	 	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 chose 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.


 


	 	17.2.	Early
    Termination.
	 	 	 	 	 
	 	 	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 [***] 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.


 




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	 	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.	GENERAL
    PROVISIONS.
	 	 	 
	 	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
    [***] 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:


 




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	 	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.


 




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	 	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 [***] 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 [***] 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]


 




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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:
    	[***]
	 	Name:
    	[***]
	 	 	 	 
	 	 	 	 	 
	Title:
    	[***]	 	Title:
    	[***]
	 	 	 	 	 
	 	 	 	 	 
	Signature:
    	/s/
    [***]	 	Signature:
    	/s/
    [***]
	 	 	 	 	 
	 	 	 	 	 
	Date:
    	June
    16, 2021	 	Date:
    	[***]

	 	 	 	 	 
	 	 	 	 	 
	Name:
    	[***]	 	Name:
    	[***]
	 	 	 	 	 
	 	 	 	 	 
	Title:
    	[***]
	 	Title:
    	[***]
	 	 	 	 	 
	 	 	 	 	 
	Signature:
    	/s/
    [***]	 	Signature:
    	/s/
                                                                                                               [***]

	 	 	 	 	 
	 	 	 	 	 
	Date:
    	June
    16, 2021	 	Date:
    	[***]
	 	 	 	 	 
	 	 	 	 	 
	Biofrontera
    Inc	 	 	 
	 	 	 	 	 
	Name:
    	[***]	 	 	 
	 	 	 	 	 
	Title:
    	[***]
	 	 	 
	 	 	 	 	 
	Signature:
    	/s/
    [***]	 	 	 
	 	 	 	 	 
	Date:
    	6/17/2021	 	 	 


 




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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.


 


EXHIBIT
3.2


 


Sales
Forecast of Ameluz® Units


 


	 	 	Year
    
2016	 	 	Year
    
2017	 	 	Year
    
2018	 	 	Year
    
2019	 
	Total Treatments/ Quantities
    (tubes)	 	 	[***]
	 	 	 	[***]
	 	 	 	[***]
	 	 	 	[***]
	 



 




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