Corrected Amendment to Amended and Restated License and Supply Agreement dated October 8, 2021 by and among Biofrontera Pharma GmbH, Biofrontera Bioscience GmbH and Biofrontera Inc

Contract Categories: Intellectual Property - License Agreements
EX-10.17 2 ex10-17.htm

 

Exhibit 10.17

 

Corrected Amendment to Amended and Restated License and Supply Agreement

 

This Corrected 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, and

 

Whereas, the Parties wish to correct certain aspects of this Amendment, as described in a previous version signed on the effective date.

 

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 and/or BIOSCIENCE nevertheless refuse to perform or finance the Improvements that are currently in development necessary clinical trials at their own cost. T, 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.

 

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

 

Biofrontera Pharma GmbH   Biofrontera Inc.
         
Date: October 13, 2021   Date: October 13, 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 13, 2021      
by: /s/[***]      
Name and Title      
         
by: /s/[***]      
Name and Title      

 

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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

 

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