Exhibit 10. 59


 


FIRST AMENDMENT TO 


 


THE MASTER DEVELOPMENT AND LICENSE AGREEMENT
FOR PRODUCTS BETWEEN ELITE PHARMACEUTICALS, INC. AND SUNGEN PHARMA, LLC


 


This Amendment, dated as of December 1, 2016 (the “Amendment”),
by and between SunGen Pharma, LLC, a limited liability company with its offices at 303C College Road East, Princeton, NJ 08540
(“SunGen”), and Elite Laboratories, Inc. (a subsidiary of Elite Pharmaceuticals, Inc.), a corporation organized under
the laws of the State of Delaware, with offices at 165 Ludlow Avenue, Northvale, New Jersey (“Elite”), relating to
that Master Development and License Agreement For Products Between Elite Pharmaceuticals, Inc. and SunGen dated August 24, 2016
(the “Agreement”);


 


WHEREAS SunGen and Elite desire
to amend the Agreement on the terms and subject to the conditions contained herein: and


 


WHEREAS, capitalized terms used
herein and not otherwise defined shall have the meaning assigned to such terms in the Agreement.


 


NOW, THEREFORE in consideration
of the mutual covenants and agreements contained herein, the sufficiency, adequacy and satisfaction of which are hereby acknowledged,
SunGen and Elite hereby agree as follows:


 


1.     A new Section 3.4 shall be added to Article
3 of the Agreement and shall read as follows:


 


		3.4	Elite shall have the exclusive right to market and sell
the {***} using Elite’s label. Elite shall be responsible for all permits, licenses, and distribution costs. Elite shall
be responsible for complying with all regulations and applicable laws and permits required to file the Product in the Territories.



 


2.     A new Section 4.4 shall be added to Article
4 of the Agreement and shall read as follows:


 


		4.4	Ownership of {***} Regulatory Filings. Elite shall be
responsible for the filing of the ANDA. SunGen shall be responsible for the prosecution of the ANDA with the FDA and shall own
the ANDA filed and/or approved. Following Regulatory Approval, SunGen shall have sole discretion with respect to the maintenance
of the ANDA, correspondence with and reporting to the FDA and other regulatory authorities, except as the Definitive Agreement
may otherwise provide in relation to Elite’s manufacturing of the Products and, provided that Elite shall cooperate with
and support SunGen in connection with any such regulatory matters to the extent that SunGen may reasonably request.



 




    
	{***} Confidential portions of this exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance with Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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3.     The table in Exhibit A (Products) of the
Agreement shall be replaced in its entirety and the new table shall read as follows:


 


	Products	 	Reference Listed
    Drug
	{***}	 	{***}
	{***}	 	{***}
	{***}	 	{***}
	{***}	 	{***}
	{***}	 	{***}


 


For the avoidance of doubt, and except for
the replacement of the table, all other language in Exhibit A of the Agreement remains unchanged.


 


4.      The table in Section 1 of Exhibit B (Payments)
of the Agreement A shall be replaced in its entirety and the new table shall read as follows:


 


	Company	 	Profit Share	 	Profit Share	 	Profit Share
	 	 	{***}	 	{***}	 	{***}
	 	 	SunGen does 

marketing & 

sales	 	Elite does 

marketing & 

sales	 	Elite does 

marketing & 

sales
	Elite	 	{***}%	 	{***}%	 	{***}%
	SunGen	 	{***}%	 	{***}%	 	{***}%


 


For the avoidance of doubt, and except for
the replacement of the table in Section 1, all other language in Section 1 of Exhibit B of the Agreement remains unchanged and
all of Section 2 of Exhibit B of the Agreement remains unchanged.


 


5.     Section 3 of Exhibit C (Roles and Responsibilities
of the Parties) of the Agreement shall be amended with the addition of a new Section 3d which shall read as follows:


 




    
	{***} Confidential portions of this exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance with Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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d.           Sourcing
API for {***} 


 


6.      Section 4 of Exhibit C (Roles and Responsibilities
of the Parties) of the Agreement shall be amended with the addition of a new Section 4d which shall read as follows:


 


d.           API
costs for the development and manufacturing of {***}. 


 


Except as expressly provided in this Amendment,
the Agreement and all provisions therein are and shall continue to be in full force and effect in accordance with its terms.


 


IN WITNESS WHEREOF, the Parties have caused this Amendment to be
executed by their duly authorized representatives as of the day and year first above written.


 


	SunGen Pharma LLC	 	Elite Laboratories, Inc.
	 	 	 	 	 
	By:	s/Jim Huang	 	By:	s/Nasrat Hakim
	Name:     Jim Huang	 	Name:     Nasrat Hakim
	Title:      CEO	 	Title:       President and CEO
	Date:      12-1-16 	 	Date:       12-1-16


 




    
	{***} Confidential portions of this exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance with Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
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