Document:

Exhibit
4.15

 

AMENDMENT
NO. 1

TO

LICENSE AND SUPPLY AGREEMENT

 

 

This
AMENDMENT NO. 1 (“Amendment No. 1”) to the LICENSE AND SUPPLY AGREEMENT dated March 10, 2014,
is entered into by and between MEDIMETRIKS PHARMACEUTICALS, INC., having its principal place of business at 383 Route 46
West, Fairfield, New Jersey 07004 (U.S.A.) (“Medimetriks”), and FERRER INTERNACIONAL, S.A., having its
head office at Av. Diagonal, 549, 5th Floor, 08029 Barcelona (Spain) (“Ferrer”), sometimes referred to herein
individually as a “Party” and collectively as the “Parties.”

 

PRELIMINARY
STATEMENTS

 

WHEREAS,
the Parties have entered into that certain License and Supply Agreement dated March 10, 2014 (the “License”),
pursuant to which, among other things, Ferrer granted Medimetriks exclusive commercialization and distribution rights to the Product
(as defined in the License) throughout the Territory (as defined in the License); and

 

WHEREAS,
the Parties wish to amend the License to, among other things, memorialize their agreement regarding (a) the prices that Ferrer
will charge Medimetriks, and Medimetriks will pay to Ferrer, for samples and other trade units of the Product not previously set
forth in the License; (b) the minimum batch quantity; (c) registration, ownership and grant of licenses for certain rights of
certain Trademarks in connection with the License, and (d) minor adjustments to the License termination provisions to enable the
transfer of the domain names registered by Company related to the Product following termination of the License.

 

NOW,
THEREFORE, in consideration of the mutual covenants, agreements, representations and warranties set forth herein, and for other
good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties to this Agreement,
intending to be legally bound, hereby agree as follows:

 

1.
This Amendment No. 1 to the License shall be deemed effective as of March 10, 2014.

 

2.
Capitalized terms used and not otherwise defined herein shall have the meanings ascribed to them in the License.

 

3.
Section 3.1(a) third paragraph of the License, which starts “Ferrer hereby agrees to provide the Company with such quantities
(...)” is hereby deleted in its entirety and Section 3.1(b) of the License is hereby deleted in its entirety and replaced
with the following:

 

“b).
Purchase commitment: The Company will buy all its requirements for trade units and samples of the Products exclusively from
Ferrer or its nominee during the term of the Agreement. Ferrer shall provide the Company with [***] sample tubes of the Product
at a fixed price of $[***] per sample tube. In addition, Ferrer shall provide the Company with [***] trade units of the Product
at a fixed price of $[***] per unit, [***] trade units of the Product at a fixed price of $[***] per unit and [***] trade units
of the Product at a fixed price of $[***] per unit (in all cases subject to Section 4.2 and the other conditions set out in Article
4 below).”

 

    	[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

    	 

    

 

4.
Section 4.2 of the License is hereby amended by deleting the first two paragraphs of Section 4.2 and adding the following as the
new first two paragraphs of Section 4.2:

 

“The
initial purchase price for trade units of the Products shall be set at $[***] per [***] sample tube of the Product, $[***] per
[***] trade unit of the Product, $[***] per [***] trade unit of the Product, and $[***] per [***] trade unit of the Product, FCA
manufacturing site (the “Supply Unit Price”). Notwithstanding the foregoing, after December 31, 2018 and during the
term of this Agreement, Ferrer may change its Supply Unit Price on any or all the Products from time to time, but no more than
once annually, based on documented actual increases to Ferrer’s direct manufacturing and labor (but specifically excluding
overhead) costs (or those charged by its nominee), provided that Ferrer furnishes the Company with at least thirty (30) days prior
written notice of any such change. The increase shall apply to any order received by Ferrer after the communication date of the
increase. In the event that the new Supply Unit Price for the Products may make the business not feasible, the Parties, in good
faith and through the Joint Steering Committee, agree to meet and negotiate in good faith an alternative solution.

 

The
purchase price for the Products shall be paid in US Dollars by the Company and such payment terms shall be [***] following the
date that the Products are received and accepted (as per Article 4.4 of the LSA) by the Company, by wire transfer into an account
designated by Ferrer. Invoices shall be generated upon shipment of Product from Supplier. Invoices should be sent by email to
the following address: invoice@cutanea.com. Failure to send invoices to the email address provided herein may cause a delay in
approval and payment. In the event that the Company does not fulfill such terms, Parties agree to discuss in good faith alternative
payment conditions. In case there is not an agreement between the Parties after 30 days, Ferrer will accept an irrevocable and
guaranteed letter of credit payable as term of payment.”

 

5.
Section 4.3 of the License is hereby amended by deleting the first sentence of Section 4.3 and adding the following first sentence
of Section 4.3:

 

“All
orders for Products hereunder shall be for a minimum batch quantity of [***]. Both Parties shall cooperate to validate and include
in the Regulatory Approvals a batch of [***], which shall thereupon be the new minimum batch quantity.”

 

    	- 2 -
	[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

    	 

    

 

6.
Article 12 of the License is hereby deleted in its entirety and replaced with the following:

 

“ARTICLE
12. OWNERSHIP AND LICENSE OF TRADEMARKS AND MARKETING AUTHORIZATION

 

The
Company shall have the right to promote and sell the Products under a trademark, logo, device, name or trade name selected by
the Company for use in connection with the packaging, labeling, promotion and sale of the Products under this Agreement. The chosen
trademark, logo, device, name or trade name to promote, sell and commercialize the Products (hereinafter collectively the “Trademarks”)
shall be registered and owned initially within the Territory by Medimetriks. Once it is legally feasible following applicable
laws and regulations, Medimetriks shall irrevocably assign and transfer to Ferrer, and Ferrer shall own, all of Medimetriks’
rights in and to any registration or application for any Trademarks and all rights in and to the Trademarks within the Territory.
By means of this Agreement, and until such time as the ownership rights of the Trademarks are irrevocably assigned and transferred
to Ferrer, Medimetriks grants to Ferrer a royalty-free, non-exclusive license to use the chosen Trademarks, in any reasonable
and lawful manner that Ferrer deems appropriate in connection with the packaging, labeling, promotion and sale of the Products
within the Territory, such use to be consistent generally with the standards that Ferrer applies to the use of its other trademarks.

 

Simultaneously
with the assignment and transfer of the chosen Trademarks to Ferrer, once that it legally feasible following applicable laws and
regulations, Ferrer shall grant, and by means of this Agreement hereby grants, to the Company, effective as of the effective date
of the assignment, a royalty-free, exclusive license to use the assigned Trademarks, subject to the Quality Standards, in any
reasonable and lawful manner that the Company deems appropriate in connection with the packaging, labeling, promotion, sale and
other commercialization of the Products in the Territory.

 

After
the assignment and transfer of the chosen Trademarks to Ferrer, the Company shall not acquire any property right, title or interest
(different than herein stated) to or in the Trademarks. The license to the Company shall be conditioned upon the Company not having
committed any material breach of this Agreement. Except as otherwise contemplated in Section 13.6 of the Agreement, upon expiry
or sooner termination of this Agreement, the license currently in place shall automatically terminate.

 

All
licensed uses of the Trademarks by the Company shall comply with such trademark usage guidelines as Ferrer may reasonably establish,
and all Product, and all marketing and promotional materials relating to the Products, bearing the Trademarks shall be of a consistent
and high quality and shall comply with such quality standards, business practices, methodology, policies and procedures, and technical
and operational specifications as reasonably established by Ferrer or as may be imposed by applicable laws (collectively, “Quality
Standards”). At the request of Ferrer, the Company shall furnish to Ferrer representative samples of the Products, and of
any materials, bearing the licensed Trademarks for quality control purposes.

 

    	- 3 -
	[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

    	 

    

 

In
addition, by means of this Agreement, Ferrer grants to the Company a royalty-free, exclusive license to use the Marketing Authorization
in any reasonable and lawful manner the Company deems appropriate for the Company’s marketing, promotion and other
commercialization of the Products in the Territory. The Company shall not acquire any property right, title or interest (different
than herein stated) to or in such Marketing Authorization. This license shall be conditioned upon the Company not having committed
any material breach of this Agreement. Except as otherwise contemplated in Section 13.6 of the Agreement, upon expiry or sooner
termination of this Agreement, this license shall automatically terminate.”

 

7.
Section 15.2 of the License is hereby deleted in its entirety and replaced with the following:

 

“Except
as otherwise contained in this Agreement or agreed to in the future by the Parties, upon termination of this Agreement for any
reason whatsoever, the Company shall return free of charge to Ferrer (or its nominee) all Ferrer confidential information, Marketing
Authorizations, domain names related by the Product registered by the Company, Ferrer Technology and/or any other information
or documentation that may be owned by Ferrer”.

 

8.
In all other respects, Medimetriks and Ferrer hereby ratify, confirm and affirm the License, as amended and modified by this Amendment
No. 1.

 

9.
This Amendment No. 1 and the rights and liabilities of the Parties shall be governed by and interpreted (in English) in accordance
with the laws of the State of New York and jurisdiction shall be granted to the federal and state courts of New York. This Amendment
No. 1 may be executed in counterparts, each of which shall be deemed an original and both of which shall constitute a single agreement.

 

[INTENTIONALLY
LEFT BLANK]

 

    	- 4 -
	[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.

    	 

    

 

IN
WITNESS WHEREOF, the Parties hereto have caused this Amendment No. 1 to be executed in duplicate by their duly authorized
officers as of March 5, 2018. One original of this Amendment No. 1 shall be held by each Party hereto.

 

	 	MEDIMETRIKS
    PHARMACEUTICALS, INC.
	 	 	                           
	 	By:	/s/
    [***]
	 	Name:	[***]
	 	Title:	[***]
	 	 
	.	FERRER
    INTERNACIONAL, S.A
	 	 	 
	 	By:	/s/
    [***]
	 	Name:	[***]
	 	Title:	[***]
	 	 	 
	 	By:	/s/
    [***]
	 	Name:	[***]
	 	Title:	[***]

 

[Counterpart
Signature Page to Amendment No. 1]

 

    	- 5 -
	[***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.Exhibit
4.16

 

CONSENT
AND ACKNOWLEDGEMENT AGREEMENT

 

This
CONSENT AND ACKNOWLEDGEMENT AGREEMENT (“Consent”), dated March 5, 2018 (“Consent Effective
Date”), is entered into by and between MEDIMETRIKS PHARMACEUTICALS, INC., having its principal place of business
at 383 Route 46 West, Fairfield, New Jersey 07004 (U.S.A.) (“Medimetriks”), CUTANEA LIFE SCIENCES, INC.,
having its principal place of business at 1500 Liberty Ridge Drive, Suite 3000, Wayne, Pennsylvania 19087 USA (“Cutanea”),
and FERRER INTERNACIONAL, S.A., having its head office at Av. Diagonal, 549, 5th Floor, 08029 Barcelona (Spain) (“Ferrer”),
sometimes referred to herein individually as a “Party” and collectively as the “Parties.”

 

WHEREAS

 

	I.	Ferrer
    and Medimetriks entered into that certain License and Supply Agreement dated March 10, 2014 (the “License”),
    as amended, pursuant to which, among other things, Ferrer granted Medimetriks exclusive commercialization and distribution
    rights to the Product (as defined in the License) throughout the Territory (as defined in the License); and
	 	 
	II.	Medimetriks
    wishes to sell, assign and transfer to Cutanea, an affiliated company of MARUHO CO., LTD. (“Maruho”), and Cutanea
    wishes to purchase, acquire and accept from Medimetriks the rights in the License.
	 	 
	III.	Medimetriks
    needs to obtain prior consent of Ferrer, as grantor of the License, owner of the Products and following Article 16 of the
    License, to allow full effects of such sale, assignment and transfer to Cutanea.

 

Capitalized
terms used and not otherwise defined herein shall have the meanings ascribed to them in the License.

 

NOW,
THEREFORE, in consideration of the mutual covenants, agreements, representations and warranties set forth herein, and for
other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties to this Consent,
intending to be legally bound, hereby agree as follows:

 

1.
Medimetriks hereby transfers and assigns all rights, duties and obligations with respect to the License to Cutanea, effective
as of the Consent Effective Date. Cutanea hereby accepts such assignment and transfer and assumes all rights, duties and obligations
with respect to the License effective as of the Consent Effective Date. Notwithstanding the foregoing, Medimetriks will not transfer
and assign, and Cutanea will not assume, any rights, duties or obligations with respect to Medimetriks’ right to register
and own the Trademarks with respect to the Product in the Territory and to grant Ferrer and Cutanea licenses thereto, until such
time as the ownership rights of such Trademarks are assigned to Ferrer in accordance with Article 12 of the License.

 

2.
Ferrer hereby accepts and consents to the transfer and assignment from Medimetriks to Cutanea, and assumption by Cutanea from
Medimetriks, upon the Consent Effective Date, of all rights, duties and obligations with respect to the License, as described
in paragraph 1 above.

 

    	 		 

    	 	 	 

    

 

3.
Upon the Consent Effective Date, this Consent, and the rights, duties, and obligations assigned hereunder, shall be enforceable
by and between Ferrer and Cutanea.

 

4.
Ferrer and Cutanea shall neither assume nor have any liability resulting from any acts or omissions of Medimetriks with respect
to the License prior to the Consent Effective Date; provided, further, that nothing in this Consent shall constitute a waiver
or release by Ferrer of any claims against Medimetriks with respect to any acts or omissions of Medimetriks with respect to the
License prior to the Consent Effective Date. It is hereby clarified that the Parties are not released from their obligations under
the License which have accrued prior to the Consent Effective Date.

 

5.
Moreover, Medimetriks and Cutanea hereby declare and warrant that neither this Consent nor the transfer of any contractual rights
from Medimetriks to Cutanea shall have any adverse effect to Ferrer, which shall be assured, among others, by fulfillment of the
obligations as set out in the License. As an additional warranty for such fulfillment, Cutanea declares that Maruho has issued
a Comfort Letter addressed to Ferrer, attached to this Consent as Annex 1. Notwithstanding the foregoing, Medimetriks shall have
no liability for any obligations of Cutanea with respect to the License from and after the Consent Effective Date.

 

6.
Retained obligation of Medimetriks under the License with respect to the Trademarks (XepiTM). At the Consent Effective
Date, registration of the Trademarks (XepiTM) is still ongoing. In accordance with the terms of Amendment No. 1 to
the License, Medimetriks shall assign to Ferrer all of Medimetriks’ rights in and to the Trademarks, once the registration
is completed or once it is feasible for Medimetriks to assign and transfer all registrations and pending applications for the
Trademarks in accordance with applicable laws and regulations, whichever occurs first. For clarity, once a notice of allowance
for any intent to use application for the Trademarks is issued under the Trademark Act by the United States Patent and Trademark
Office (USPTO), Medimetriks shall promptly file a statement of use (SOU) or, if use in commerce cannot be demonstrated on or before
the deadline for filing the SOU, Medimetriks shall file such extensions of time as may be necessary and feasible until a SOU can
be filed.

 

7.
Concurrently with the assignment and transfer of the License, Cutanea has agreed to designate and appoint Medimetriks as its sole
and exclusive authorized distributor of unbranded Product (“Generic Product”) pursuant to the provisions of the License
(the “AG Agreement”). The Parties are all in agreement to confirm that any Net Sales of Products generated under the
AG Agreement are to be included as Net Sales under the License and, consequently, those Net Sales are also subject to the royalty
to be paid by Cutanea to Ferrer following Article 3.1 c) of License.

 

8.
Medimetriks and Cutanea shall be liable for any breach of its obligations as set out in this Consent and consequently, pursuant
to applicable law, shall indemnify and hold harmless Ferrer, against any Loss that Ferrer may incur as a result of any such breach.
To the purposes of this Consent, “Loss” means all liability, third party claims and other claims, actions, and judgments,
including but not limited to attorney’s fees and investigation costs. Medimetriks shall be severally liable for its own
breach of any of its obligations as set out in this Consent.

 

9.
This Consent and the rights and liabilities of the Parties shall be governed by and interpreted (in English) in accordance with
the laws of the State of New York and jurisdiction shall be granted to the federal and state courts of New York. This Consent
may be executed in counterparts, each of which shall be deemed an original and both of which shall constitute a single agreement.

 

[INTENTIONALLY
LEFT BLANK]

 

    	 	- 2 -	 

    	 	 	 

    

 

IN
WITNESS WHEREOF, the Parties hereto have caused this CONSENT AND ACKNOWLEDGEMENT AGREEMENT to be executed in duplicate
by their duly authorized officers as of March 5, 2018. One original of this Consent shall be held by each Party hereto.

 

	 	MEDIMETRIKS
    PHARMACEUTICALS, INC.
	 	 	                               
	 	By:	/s/
    [***]
	 	Name:	[***]
	 	Title:	[***]

 

	 	FERRER
    INTERNACIONAL, S.A.
	 	 	                           
	 	By:	/s/ [***]
	 	Name:	[***]
	 	Title:	[***]
	 	 	 
	 	By:	/s/
    [***]
	 	Name:	[***]
	 	Title:	[***]

 

	 	CUTANEA
    LIFE SCIENCES, INC.
	 	 	
		By:	/s/
    [***]
	 	Name:	[***]
	 	Title:	[***]

 

[Counterpart
Signature Page to Consent and Acknowledgement Agreement]

 

    	 	- 3 -	 

    	 	 	 

    

 

ANNEX
1

MARUHO
COMFORT LETTER

 

    	 	- 4 -

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