Exhibit
10.54


 


EXPLANATORY
NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT


THAT
HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND


(II)
WOULD BE COMPETITIVELY HARMFUL IN PUBLICLY DISCLOSED.



 


FIRST
AMENDMENT TO 


 


THE
LICENSE, SUPPLY AND DISTRIBUTION AGREEMENT BETWEEN ELITE


PHARMACEUTICALS, INC./ELITE LABORATORIES, INC. AND LANNETT COMPANY, INC.






 


This
Amendment, dated as of July 29, 2019 (the “Amendment”), by and between Elite Pharmaceuticals, Inc., a Nevada corporation
and Elite Laboratories, Inc., a Delaware corporation with offices at 165 Ludlow Avenue, Northvale, New Jersey 07647 (collectively
“Elite”) and Lannett Company, Inc., a Delaware corporation located at 9000 State Road, Philadelphia, PA 19136 and/or
its Affiliates (“Lannett”) (and together the “Parties”) relating to that License, Supply and Distribution
Agreement between the Parties dated March 6, 2019 (the “Agreement”);


 


WHEREAS
Lannett 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, Lannett and Elite hereby agree as follows:





 


		1.	Section
                                         1.1 (v) shall be replaced in its entirety with the new Section 1.1 (v) below:



 


v.
“Net Profits” is calculated as listed in Schedule C and means the Net Sales of a Product minus the sum of (i)
the Distribution Fee, (ii) Transfer Price of Product and (iii) shipping costs from the Facility:


 






    1


     


    




 





EXPLANATORY NOTE: [***] INDICATES THE
PORTION OF THIS EXHIBIT


THAT HAS BEEN OMITTED BECAUSE IT IS BOTH
(I) NOT MATERIAL AND


(II) WOULD BE COMPETITIVELY HARMFUL IN
PUBLICLY DISCLOSED.







 


		2.	Section
                                         3.3 shall be replaced in its entirety with new Section 3.3 below:



 


		a.	License
                                         Fees. Throughout the Initial Term and Renewal Term, LANNETT shall pay to ELITE *** percent
                                         (***%) of the Net Profits received from sales of each Product within forty-five (45)
                                         days of the end of each calendar quarter (“License Fees”). Such payment shall
                                         additionally include a sales summary for each Product, generally in the format as provided
                                         in Schedule C. In no case shall the License Fees for any calendar quarter be negative;
                                         provided, however, in the event of a loss in any calendar quarter, subject to ELITE’s
                                         written approval of any Product pricing by LANNETT that leads to quarterly losses and
                                         subject to the loss carryover clause that follows, the amount of that loss shall be carried
                                         forward to subsequent calendar quarters until the amount of such loss has been fully
                                         absorbed. In the event that Net Profits for calendar quarter are negative, LANNETT shall
                                         carry over *** percent (***%) of the value by which the Net Profits are negative in such
                                         calendar quarter and deduct this amount from the calculation of Net Sales for the following
                                         calendar quarter. If Net Profits are negative in two (2) or more consecutive calendar
                                         quarters, LANNETT shall invoice ELITE for *** percent (***%) of the value by which the
                                         Net Profits are negative for the previous calendar quarter and carry over *** percent
                                         (***%) of the value by which Net Profits are negative for the current calendar quarter
                                         and deduct this amount from the calculation of Net Sales for the following calendar quarter.
                                         For the avoidance of doubt, if Net Profits are negative in subsequent calendar quarters,
                                         the amounts will be similarly carried over or reimbursed as per the terms set forth in
                                         this Section 3.3 until Net Profits are positive. Reimbursement of negative Net Profits
                                         owed by ELITE in this Section 3.3 shall be payable to LANNETT within forty-five (45)
                                         days after receipt of an invoice from LANNETT.















 


		3.	The
                                         Title Page for the Schedules that follows the signatures and precedes the schedules shall
                                         be replaced in its entirety with the new titles listed below:



 


Schedule
A:Products


 


Schedule
B:Product Specifications


 


Schedule
C:Quarterly Report for Calculation of Net Profit


 


Schedule
D: Shipping Instructions





 


		4.	Schedule
                                         C of the Agreement shall be replaced in its entirety with new Schedule C below:



 






    2


     


    

 





EXPLANATORY NOTE: [***] INDICATES THE
PORTION OF THIS EXHIBIT


THAT HAS BEEN OMITTED BECAUSE IT IS BOTH
(I) NOT MATERIAL AND


(II) WOULD BE COMPETITIVELY HARMFUL IN
PUBLICLY DISCLOSED.







 


Schedule
C


 


Quarterly
Report for Calculation of NET Profit





 


Product
Name:________________________________________________________


 


	Quantity
    sold by SKU	XXXX
    units
	Gross
    Sales	$
	Deductions:	 
	Chargebacks	 
	Rebates	 
	ADministrative
    Fees	 
	Billbacks	 
	Returns	 
	Shelf
    Stock Adjustments	 
	Other
    deductions	 
	Cash
    Discounts	 
	Medicaid	 
	NET
    SALES	$
	Transfer
    Price	 
	DIstribution
    FEES	 
	Shipping
    COsts	 
	NET
    PROFIT	 
	Profit
    share Payment to ELITe at THE APPLICABLE LICENSE FEE PERCENTAGE SET FORTH IN SECTION 3.3	 


 




    3


     


    

 





EXPLANATORY NOTE: [***] INDICATES THE
PORTION OF THIS EXHIBIT


THAT HAS BEEN OMITTED BECAUSE IT IS BOTH
(I) NOT MATERIAL AND


(II) WOULD BE COMPETITIVELY HARMFUL IN
PUBLICLY DISCLOSED.







 


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.


 


	Elite Pharmaceuticals, Inc.	 	Lannett Company, Inc.
	 	 	 	 	 
	By:	s/
    Nasrat Hakim	 	By:	s/
    John Kozlowski 
	Name:	Nasrat Hakim	 	Name: 	John Kozlowski
	Title:	President and CEO	 	Title:	COSSO
	Date:	7-29-2019	 	Date:	7-31-2019


  


	Elite Laboratories, Inc.	 
	 	 	 
	By:	s/
    Nasrat Hakim	 
	Name:	Nasrat Hakim	 
	Title:	President and CEO	 
	Date:	7-29-2019	 


  




 


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