Exhibit 10.53


 


AMENDMENT TO LICENSE, DEVELOPMENT AND COMMERCIALIZATION
AGREEMENT


 


This AMENDMENT (the “Amendment”)
to the LICENSE, DEVELOPMENT and COMMERCIALIZATION AGREEMENT (the “Agreement”) dated June 28, 2019 between Acura Pharmaceuticals,
Inc. (“Acura”), a New York corporation, having a place of business at 616 N. North Court, Suite 120, Palatine, IL 60067,
and Abuse Deterrent Pharma, LLC (“AD Pharma”), a Kentucky partnership having a place of business at with offices at
333 E. Main Street, Suite 220, Louisville, Kentucky 40202, is made as of October 16, 2020.


 


RECITALS


 


WHEREAS, Acura and
AD Pharma are parties to the Agreement which became effective on June 28, 2019 and;


 


WHEREAS, the Parties
desire to amend the Agreement as set forth herein to provide for an extension to the LIMITxTM Regulatory Submission Timeline.


NOW THEREFORE, in consideration
of the mutual covenants and promises contained in the Agreement and this Amendment and other good and valuable consideration, the receipt
and sufficiency of which are hereby acknowledged, Acura and AD Pharma agree as follows:


 


ARTICLE
1

AMENDMENTS TO AGREEMENT


 


1.1             
A new Section 1.50 is hereby added to the Agreement as follows:


 


“Oxycodone Product”
means a pharmaceutical product containing the immediate-release combination of oxycodone hydrochloride and acetaminophen utilizing the
LIMITXTM Technology in the 5/325mg, 7.5/325mg and 10/325mg dosage strengths.


 


1.2             
Section 1.34 is hereby amended and replaced in its entirety as follows:


 


“Product”
means a pharmaceutical product containing the immediate-release combination of hydrocodone bitartrate and acetaminophen utilizing the
LIMITXTM Technology in the 5/325mg, 7.5/325mg and 10/325mg dosage strengths (the “Hydrocodone Product”) along
with the Alprazolam Product and the Oxycodone Product.


 


1.3             
Section 2.3 with respect to “Acura to use CRE” is hereby amended and replaced in its entirety as follows:


 


Acura to use
CRE. Acura shall use Commercially Reasonable Efforts to develop the Product in the United States, provided however, that any
obligation of Acura to develop the Alprazolam Product and the Oxycodone Product will be subject to a separate development agreement
to be negotiated between the Parties. Acura shall comply with all Applicable Laws in the development of the Product. For the
avoidance of doubt, Acura’s obligations to develop a Product and any related development timelines and milestones shall be
strictly limited to the Hydrocodone Product.


 






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1.4             
Section 2.11 is hereby amended by inserting at the end:


 


The foregoing provisions
of this Section 2.11 are limited to the Hydrocodone Product.


 


1.5             
Section 3.1.1 of hereby amended and replaced in its entirety as follows:


 


In an aggregate amount
not to exceed Six Million Five Hundred Thousand Dollars ($6,500,000) (the “Maximum Pre-Regulatory Application Submission Payment”),
each month AD Pharma shall pay Acura in non-refundable, non-creditable payments in immediately available funds as follows:


 


		·	Three Hundred Fifty Thousand Dollars ($350,000) commencing within Five (5) days of the Effective Date
and continuing until April 2020; and



 


		·	Two Hundred Thousand Dollars ($200,000) commencing in May 2020 and continuing on the monthly anniversary
of the Effective Date until the earlier of July 2021 or such monthly payments have occurred or the Maximum Pre-Regulatory Application
Submission Payment is reached (as the timing of the latter, but not the amount, may be adjusted in accordance with Section 3.1.2).



 


1.6             
Section 3.4 is hereby amended and replaced in its entirety as follows, provided however that subsection 3.4.1 and 3.4.2 remain
as in the Agreement:


 


Sales Milestone
Payments. AD Pharma shall make the following one-time, non-refundable, non-creditable payments within forty-five (45) days after the
end of the year to Acura based on the attainment of the Net Sales in such calendar year for each Product and Product Line Extensions individually
(i.e. a separate payment for each of the Hydrocodone Product, the Alprazolam Product and the Oxycodone Product) in the Territory (the
 “Milestone Payments”):


 


1.7             
Section 3.12 “Option under Nexafed® Agreement” is hereby deleted in its entirety.


 


1.8             
Section 3.13 “Option for license to Alprazolam Product” is hereby deleted in its entirety.


 


1.9             
Item 3 of Schedule 1 “LIMITxTM Regulatory Application Submission Timeline” is hereby amended and replaced
in its entirety as follows:


 


3. By the last day
of the calendar month when the last of the monthly payments for the Maximum Pre-Regulatory Application Submission Payment has occurred,
or before, Acura must gain filing acceptance by the FDA of a Regulatory Approval Application for the Product.


 






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For the avoidance
of doubt, Schedule 1 is strictly limited to activities and timelines related to the Hydrocodone Product.


 


ARTICLE
2

MISCELLANCEOUS


 


2.1             
Governing Law. This Amendment shall be governed by the laws of the State of New York without regard to its conflict of laws
rules or principles.


 


2.2             
Amendments. Except as expressly amended hereby, the Agreement shall remain unmodified and in full force and effect.


 


2.3             
Entire Agreement. This Amendment, the Agreement and the Schedules attached to the Agreement constitute the entire agreement
of the Parties with respect to the subject matter hereof and supersede all prior understandings and writings between the Parties relating
thereto.


 


2.4             
Interpretation. Any capitalized terms used in this Amendment and not otherwise defined herein shall have the meanings provided
in the Agreement.


 


2.5             
Counterparts. This Amendment may be executed manually, electronically in Adobe® PDF file format, or by facsimile by the
Parties, in any number of counterparts, each of which shall be considered one and the same amendment and shall become effective when a
counterpart hereof shall have been signed by each of the Parties and delivered to the other Party.


 


IN WITNESS WHEREOF, the Parties hereto have
caused this Amendment to be executed in their names by their properly and duly authorized officers or representatives as of the date first
written above.


 


	ACURA PHARMACEUTICALS, INC.	 
	 	 
	s/s Robert B. Jones, 10/12/2020	 
	Name:   Robert B. Jones	 
	Title:     CEO and President	 




 


	Abuse Deterrent Pharma, LLC	 
	 	 
	s/s John Schutte, 10/16/2020	 
	Name:   John Schutte	 
	Title:    Managing Partner	 




 






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