Exhibit 10.1


 


FIRST Amendment to License Agreement


 


This
FIRST AMENDMENT TO LICENSE AGREEMENT (this “First Amendment”) is made and entered into as of March 31, 2022 (the
 “First Amendment Effective Date”) between RVL Pharmaceuticals, Inc., a Delaware corporation (“RVL”)
and Santen Pharmaceutical Co. Ltd., a Japanese corporation (“Licensee”).  RVL and Licensee may be referred to
herein individually as a “Party” and collectively as the “Parties.”


 


WHEREAS, RVL and Licensee entered into that certain
License Agreement, dated as of July 28, 2020 (the “Original Agreement”);


 


WHEREAS, Licensee wishes to expand the Territory
to include certain countries as set forth herein and RVL wishes to include such additional countries in the Territory;


 


WHEREAS, RVL wishes to grant Licensee an option,
and Licensee wishes to receive an option, to expand the Territory further, pursuant to the terms contained herein;


 


WHEREAS, Licensee and RVL wish the amend certain
milestone events and milestone payments in the Original Agreement;


 


WHEREAS, in consideration for such expansion of
the Territory and amendment to the milestone events and milestone payments, in each case, as set forth herein, Licensee desires pay to
RVL, and RVL desires to receive, the Amendment Payments (as defined herein); and


 


WHEREAS, pursuant to and in accordance with Section 11.8
of the Original Agreement, the Parties desire to make certain amendments to the Original Agreement.


 


NOW, THEREFORE, in consideration of the promises
and covenants contained in this First Amendment, and intending to be legally bound, the Parties hereby agree as follows:


 


	1.	Interpretation. Capitalized terms not defined in this First Amendment have the meanings given such
terms in the Original Agreement. References to Sections and Schedules herein will be to Sections and Schedules of the Original Agreement,
except as otherwise noted.



 


	2.	New Definitions. The following definitions are hereby added to Article 1 of the Original Agreement:



 


		a.	“HC” means Health Canada and any successor entity thereto.



 


		b.	“MHP” means the United Arab Emirates Ministry of Health and Prevention and any successor
entity thereto.



 


	3.	Amendment Payment. Within thirty (30) days from the First Amendment Effective Date, Licensee shall
pay to RVL the following nonrefundable, noncreditable amounts:



 


		a.	An amount equal to $5,500,000 to expand the Territory as set forth in Section 5 (Territory Amendments);



 


		b.	An amount equal to $3,500,000 for deletion of the milestone payment due under the Original Agreement following
receipt of the first Regulatory Approval for a Licensed Product by any of the EMA, a Regulatory Authority of a member of the European
Union, or a Regulatory Authority of any country identified as “Other European Countries” on Schedule 1.108 in the Original
Agreement;



 






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		c.	An amount equal to $3,500,000 for deletion of the milestone payment due under the Original Agreement following
receipt of the first Regulatory Approval by the MHLW for a Licensed Product in Japan; and



 


		d.	An amount equal to $3,000,000 for deletion of the milestone payment due under the Original Agreement following
receipt of the first Regulatory Approval by the NMPA for a Licensed Product in the People’s Republic of China (the amounts set forth
in the foregoing clauses (a) through (d), collectively, the “Amendment Payments”).



 


For clarity, other than the Amendment
Payments to be paid as set forth above in this Section 3, Licensee will not owe to RVL any payments due upon receipt of Regulatory
Approval for a Licensed Product by any of the EMA, a Regulatory Authority of a member of the European Union, a Regulatory Authority of
any country identified as “Other European Countries” on Schedule 1.108 in the Original Agreement, MHLW, or the NMPA.


 


	4.	Development and Regulatory Milestone Payment Amendments. Section 5.2.1 of the Original Agreement
is hereby deleted in its entirety and replaced with the following:



 


“5.2.1     Development
and Regulatory Milestones. In partial consideration of the rights granted by RVL to Licensee hereunder, Licensee shall notify RVL
within two (2) Business Days after the achievement of each of the following milestones for the Licensed Product and shall pay to
RVL a milestone payment for the achievement of each such milestone within thirty (30) days after receiving an invoice from RVL for such
milestone payment, calculated as follows:


 


(i)            following
receipt of the first Regulatory Approval by the MHP for a Licensed Product in the United Arab Emirates, five hundred thousand Dollars
($500,000); and


 


(ii)           if
Licensee receives Regulatory Approval by the HC in Calendar Year 2023 for a Licensed Product in Canada, five hundred thousand Dollars
($500,000).


 


Each milestone payment in this Section 5.2.1
shall be payable only upon the first achievement of such milestone and no amounts shall be due for subsequent or repeated achievements
of such milestone, whether for the same or a different Licensed Product.”


 


		5.	Territory Amendments.



 


		a.	Section 2 of Schedule 1.108 is hereby deleted in its entirety and replaced with the following:



 


“2. North Africa and Middle East


 


a.
Algeria, Bahrain, Egypt, Iran, Iraq, Israel, Jordan, Lebanon,
Kingdom of Saudi-Arabia, Kuwait, Morocco, Qatar, Turkey, United Arab Emirates.”


 






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		b.	The following provision is hereby added to Schedule 1.108 of the Original Agreement:



 


“4. North America


 



a. Canada”


 


	6.	Option to Expand Territory. Prior to the earlier of (i) the fifth anniversary of the First
Amendment Effective Date or (ii) the expiration of ROFN period as defined below (the “Option Exercise Period”),
Licensee may elect, upon written notice to RVL, to expand the Territory to include Russia in accordance with the terms set forth in this
Section 6 (Option to Expand Territory). If Licensee so elects to expand the Territory, then:



 


		a.	In consideration of the option grant and expanding the Territory to include Russia, Licensee would pay
to RVL $2,000,000 (the “Option Exercise Payment”) no later than thirty (30) days after the date of written notice Licensee’s
election to expand the Territory to so include Russia.



 


		b.	The following definition will be added to Article 1 of the Original Agreement:



 


“MHRF” means the
Ministry of Health of the Russian Federation and any successor entity thereto.


 


		c.	The following milestone will be added Section 5.2.1 (Development and Regulatory Milestones) of the
Original Agreement, and will be subject to the terms therein:



 


“(iii) Following receipt
of the first Regulatory Approval by the MHRF for a Licensed Product in Russia, one million Dollars ($1,000,000) (such payment, the “Russia
Regulatory Approval Milestone”).”


 


	7.	Third Party Russia Offer.
If at any time during the Option Exercise Period, RVL desires to enter into, or is approached by any bona fide third party with
respect to, an agreement to license certain rights under the RVL Patents, RVL Know-How, or RVL’s interests in the Joint Patents
and Joint Know-How to Exploit the Licensed Product in Russia (a “Third Party Russia Offer”), then RVL will notify Licensee
of the Third Party Russia Offer in writing. The Licensee will have a period of forty-five (45) days following its receipt of written notice
of the Third Party Russia Offer (the “ROFN Period”) to notify RVL in writing of Licensee’s desire to either (“Russia
Terms Notice”) (i) exercise its option to expand the Territory to include Russia pursuant to Section 6 (Option to
Expand Territory) of this First Amendment, or (ii) in lieu of the Option Exercise Payment and the terms under the Original Agreement
that would be applicable to the Exploitation of the Licensed Product if the Territory were to be expanded to include Russia, in consideration
for the expansion of the Territory to include Russia, to match the terms offered to RVL by the Third Party Russia Offer (the “Matched
Terms”). If, during such ROFN Period Licensee elects to match the terms last offered to RVL by the third party in consideration
for the grant of rights to Exploit the Licensed Product in Russia, then (a) Licensee and RVL will enter into an amendment to the
Original Agreement that replaces original terms that would be due to RVL in consideration for expansion of the Territory to include Russia
(including the Option Exercise Payment) and instead includes the Matched Terms and (b)  the option set forth in Section 6 (Option
to Expand Territory) of this First Amendment will immediately terminate. During the ROFN Period, RVL will not negotiate with any
third party or enter into any agreement with any third party regarding any transfer, license, or acquisition of RVL’s rights under
the RVL Patents, RVL Know-How, or interests in the Joint Patents and Joint Know-How, in each case to Exploit the Licensed Product in Russia
unless and until Licensee notifies RVL that it has decided not to pursue the acquisition or grant of such rights. If Licensee does not
deliver to RVL a Russia Terms Notice prior to the expiration of the ROFN Period, then RVL will be free to negotiate or enter into any
transaction with any third party with no further obligation to Licensee under this Section 7 (Third Party Russia Offer).



 






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	8.	Licensee’s Clinical Research Rights. Regardless of whether Licensee elects to exercise its
option to expand the Territory to include Russia pursuant to Section 6 (Option to Expand Territory) of this First Amendment or whether
RVL licenses certain rights under the RVL Patents, RVL Know-How or RVL’s interests in the Joint Patents and Joint Know-How to Exploit
the Licensed Product in Russia to a bona fide third party pursuant to Section 7 (Third Party Russia Offer) of this First Amendment,
Licensee may, under and consistent with the license grants contained in Article 2 of the Original Agreement, conduct clinical development
of the Licensed Product in Russia subject to RVL’s prior written approval.



 


	9.	Effect on Original Agreement. Except as specifically amended by this First Amendment, the Original
Agreement will remain in full force and effect and is hereby ratified and confirmed. Each future reference to the Original Agreement will
refer to the Original Agreement as amended by this First Amendment. To the extent a conflict arises between the terms of the Original
Agreement and this First Amendment, the terms of this First Amendment shall prevail but only to the extent necessary to accomplish their
intended purpose.



 


	10.	Binding Effect. This First Amendment will be binding upon and inure to the benefit of the Parties
and their respective permitted successors and assigns.



 


	11.	Authority. As of the First Amendment Effective Date, each Party hereby represents and warrants
that (a) it has the power and authority to execute and deliver this First Amendment, (b) the execution, delivery, and performance
of this First Amendment by it has been duly authorized by all requisite corporate action, and (c) this First Amendment has been duly
executed and delivered on behalf of such Party and constitutes a legal, valid, and binding obligation of such Party and is enforceable
against it in accordance with its terms.



 


	12.	Governing Law. This First Amendment and all amendments, modifications, alterations, or supplements
hereto, and the rights of the Parties, will be construed under and governed by the laws of the State of New York, excluding any conflicts
or choice of law rule or principle that might otherwise refer construction or interpretation of this First Amendment to the substantive
law of another jurisdiction. The Parties agree to exclude the application to this First Amendment of the United Nations Convention on
Contracts for the International Sale of Goods.



 


	13.	Amendments. This First Amendment may not be modified or amended, except by another agreement in
writing executed by duly authorized signatories of each Party.



 


	14.	Counterparts. This First Amendment may be executed in two or more counterparts, all of which taken
together will be regarded as one and the same instrument. Each Party may execute this First Amendment in AdobeTM Portable Document
Format (PDF) sent by electronic mail. PDF signatures of authorized signatories of the Parties will be deemed to be original signatures,
will be valid and binding upon the Parties, and, upon delivery, will constitute due execution of this First Amendment.



 


[Signatures Follow]


 






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IN WITNESS WHEREOF, the Parties
have executed this First Amendment to License Agreement through their duly authorized representatives.


 


	Santen Pharmaceutical Co., Ltd.	 
	 	 
	By:	/s/
    Satoshi Suzuki	 
	 	 
	Name:	Satoshi Suzuki	 
	 	 
	Title: 	Senior Corporate Officer, Head of Corporate Development Division	 
	 	 
	RVL Pharmaceuticals, Inc.	 
	 	 
	By:	/s/ Brian Markison	 
	 	 
	Name:	Brian Markison	 
	 	 
	Title: 	Chief Executive Officer	 




 


[Signature
Page To First Amendment To License Agreement]