Exhibit
10.17


 


Amendment
to Amended and Restated License and Supply Agreement


 


This
Second Amendment to License and Supply Agreement (the “Amendment”) is made effective as of October 8, 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, Woburn, MA 01801, USA (“INC”).
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.


 


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) and subsequently amended and restated
in its entirety on June 17, 2021 (collectively, the “LSA” or the “Agreement”); and


 


Whereas,
the Parties wish to modify or specify the respective aspects of the Agreement.


 


Now,
therefore, in consideration of the foregoing and the agreements contained here, the Parties hereto, intending to be legally bound hereby
agree as follows:


 


Agreement


 


	1.	Amendment
                                            to LSA. As of the effective date of this Amendment:



 


		a.	Section
                                            6.2 of the LSA shall be amended to read in its entirety as follows (added language appears
                                            in italics, deleted language appears in strikethrough):



 


“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 a certain fifty percentage (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”), as specified below:


 


		-	50%
                                            of the Anticipated Net Price Per Unit on the first $30 million USD in revenue from sales
                                            of Licensed Products during a given calendar year; 



 


		-	40%
                                            of the Anticipated Net Price Per Unit on all revenue generated from sales of Licensed Products
                                            between $30 million USD and $50 million USD during a given calendar year;



 




    	 



    	 



    

 


		-	30%
                                            of the Anticipated Net Price Per Unit on all revenue generated from sales of Licensed Products
                                            above $50 million USD during a given calendar year.



 


.
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.”


 


		b.	Section
                                            7.1(b) of the LSA shall be amended to read in its entirety as follows (added language appears
                                            in italics, deleted language appears in strikethrough):



 


“In
the event that, during the Term, PHARMA and/or BIOSCIENCE develops any Improvements with respect to the use of
Licensed Products in the Field, PHARMA and/or 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.


 


		c.	Section
                                            7.1(c) of the LSA shall be amended to read in its entirety as follows (added language appears
                                            in italics, deleted language appears in strikethrough):



 


“PHARMA
and BIOSCIENCE have the obligation to undertake clinical development in continue to pursue, in good faith, all Improvements
that are currently in development by PHARMA and/or BIOSCIENCE in a timely manner at their own cost for the improvement of the US
label of the Licensed Product(s) in order to fully exploit the market potential of such Product(s). A complete list of the Improvements
that are currently in development is provided as Exhibit A. PHARMA and/or BIOSCIENCE may, but are not obligated to, pursue additional
future Improvements (i.e. those Improvements not listed on Exhibit A) at their own cost for the improvement of the US label of the Licensed
Product(s) in order to further exploit the market potential of such Product(s). 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.


 


		d.	Section
                                            7.2(b) of the LSA shall be deleted in its entirety and replaced only with “[Reserved]”.



 


		e.	Section
                                            7.3(b) of the LSA shall be deleted in its entirety and replaced only with “[Reserved]”.



 


	2.	Continuing
                                            Effect of Original Agreement. This Amendment shall only serve to amend and modify the
                                            LSA to the extent specifically provided herein. All terms, conditions, provisions, exhibits
                                            and references of and to the LSA that are not specifically modified and/or amended herein
                                            shall remain in full force and effect and shall not be altered by any provisions herein contained.
                                            On and after the date of this Amendment, each reference in the LSA to “this Agreement,”
                                            “hereunder,” “hereof,” “herein” or words of like import,
                                            and each reference to the LSA, including the exhibits relating thereto, in any other agreements,
                                            documents or instruments executed and delivered pursuant to the LSA, shall mean and be a
                                            reference to the LSA as amended by this Amendment; provided, that references to “the
                                            date of this Agreement,” “the date hereof,” and other similar references
                                            in the LSA shall continue to refer to the date of the original LSA and not to the date of
                                            this Amendment.



 


[Remainder
of page intentionally left blank; Signature page follows]


 




    	2



    	 



    

 


IN
WITNESS WHEREOF, the Parties have executed this Amendment to Amended and Restated License and Supply Agreement as of the date first set
forth above.


 


	Biofrontera Pharma GmbH	 	Biofrontera Inc.
	 	 	 	 	 
	Date:  	October 8, 2021 	 	Date: 	October
    8, 2021
	by:
    	/s/[***]	 	by:
    	/s/[***]
	Name and Title	 	Name and Title
	 	 	 	 	 
	by:
    	/s/[***]	 	by:
    	/s/[***]
	Name and Title	 	Name and Title
	 	 	 	 	 
	Biofrontera Bioscience GmbH	 	 	 
	 	 	 	 	 
	Date:	October
    8, 2021	 	 	 
	by:	/s/[***]	 	 	 
	Name and Title	 	 	 
	 	 	 	 	 
	by:	/s/[***]	 	 	 
	Name and Title	 	 	 


 




    	3



    	 



    

 


Exhibit
A


 


Amended
and Restated License and Supply Agreement


 


Improvements
that are Currently in Development (Section 7.1(b))


 


	Product	 	Indication	 	Study
    type	 	Anticipated
    start of patient recruitment
	BF-RhodoLED®
    XL	 	PDT
    lamp for illumination of larger body regions	 	Not
    applicable	 	submitted
    to FDA in Q2 2021
	Ameluz®	 	Actinic
    keratosis	 	Pharmacokinetics
    study 	 	completed
	Ameluz®	 	Superficial
    basal cell carcinoma	 	Phase
    III	 	ongoing
	Ameluz®	 	Actinic
    keratosis	 	Phase
    I safety study with 3 tubes of Ameluz®	 	H2
    2021
	Ameluz®	 	Moderate
    to severe acne	 	Phase
    IIb	 	H2
    2021
	Ameluz®	 	Actinic
    keratosis	 	Phase
    III on face and scalp with 3 tubes and pain-reducing illumination protocol	 	2022
	Ameluz®	 	Actinic
    keratosis	 	Phase
    III on trunk & extremities	 	2022
	Ameluz®	 	Squamous
    cell carcinoma in situ	 	Phase
    III	 	2023


 




    	4