Exhibit 10.50


 


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.


 


SECOND AMENDMENT TO 


 


THE LICENSE, SUPPLY AND DISTRIBUTION
AGREEMENT BETWEEN ELITE PHARMACEUTICALS, INC./ELITE LABORATORIES, INC. AND GLENMARK PHARMACEUTICALS INC. USA


 


This Amendment, dated as of January 2, 2020 (the “Amendment”),
by and between Elite Laboratories, Inc., a Delaware corporation, and Elite Pharmaceuticals, Inc., a Nevada corporation, with offices
at 165 Ludlow Avenue, Northvale, New Jersey (“Elite”) and Glenmark Pharmaceuticals Inc. USA, a Delaware corporation
located at 750 Corporate Drive, Mahwah, New Jersey 07430 (“Glenmark”) relating to that License, Supply and Distribution
Agreement Between Elite and Glenmark dated May 22, 2018 and the Second Amendment to the License, Supply and Distribution Agreement
dated August 1, 2018 (together the “Agreement”);


 


WHEREAS Glenmark 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, Glenmark and Elite hereby agree as follows:


 


		1.	The Parties agree to amend the Agreement by terminating the license for Methadone HCl 5 mg on December
31, 2019 and 10 mg tablets and Phendimetrazine 35 mg tablets on February 28, 2020. Schedule A of the Agreement shall be replaced
in its entirety with new Schedule A listed below:



 




    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.


    

SCHEDULE A


 


Products and Prices 


 


Product List


	Generic Name	ANDA #	Reference Listed Drug	Market exclusivity grant from ELITE
	Trimipramine 25 mg, 50 mg, 100 mg capsule	077361	Surmontil® (Trimipramine Maleate) Capsules mfg by Teva Pharmaceuticals Industry Ltd.)	Exclusive
	Isradipine 2.5 mg, 5.0 mg capsule	077169	Dynacirc® (Isradipine) Capsules mfg by GlaxoSmithKline	Exclusive


 


Products and Prices


 


Transfer Prices ($/bottle)


	Name	Full Batch Qty.	Bottle Size	Cost per bottle
	Trimipramine Maleate capsule, 25 mg	65,000 capsules	30 count	$[***]
	Trimipramine Maleate capsule, 50 mg	150,000 capsules	30 count	$[***]
	Trimipramine Maleate capsule, 100 mg	150,000 capsules	30 count	$[***]
	Isradipine capsules, 2.5 mg	125,000	100 count	$[***]
	Isradipine capsules, 5.0 mg	125,000	100 count	$[***]


 


Pricing includes all Product manufacturing
and packaging costs, quality assurance, batch quality control testing and stability testing, and is subject pricing adjustments
in Section 4.1(d).


 




    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.


    

		2.	Schedule B of the Agreement shall be replaced in its entirety with new Schedule B listed below:


 


SCHEDULE B


 


PRODUCT SPECIFICATIONS


 


Elite Pharmaceuticals Inc.


FINISHED PRODUCT ANALYSIS


	Trimipramine Maleate Capsules Equivalent to 25mg of Trimipramine	Number: SP0850
	
        Manufacturer:

        Elite Laboratories, Inc
	
        DEPARTMENT:

        ANALYTICS AND QC
	Version: 1	Item Code: 0850
	QC#:	Batch #:	
        Manufacturing Date:

         

        Expiration Date:
	 


 


	Test / Method 	Specification 	Results 	Reference 
	Appearance Visual 	#2 Capsules, light blue opaque cap, yellow opaque body, imprinted “A-293” in black ink on cap and body, filled with white to off-white powder 	 	 
	
        Identification

        A. HPLC

        ATM-0850-ASCU
	The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay 	 	 
	
        Identification

        B. Ultraviolet Absorption

        ATM-0850-ASCU
	The UV spectrum of the Sample solution exhibits maxima only at the same wavelength as those obtained from that of standard solution, as obtained in the Assay 	 	 
	
        Assay

        ATM-0850-ASCU
	90.0% -110.0% 	 	 
	Uniformity of Dosage Units by Content Uniformity ATM-0850-ASCU 	Meets USP <905> requirements 	 	 
	Organic Impurities ATM-0850-IMP 	
        a. Iminodibenzyl:
        NMT 0.2%

        b. Imipramine:
        NMT 0.2%

        c. Dehydro
        Trimipramine: NMT 0.2%

        d. Single
        Largest Individual Unspecified Impurity:

        NMT 0.1%

        e. Total
        Known and Unknown Impurities: NMT 0.5%
	 	 
	
        Dissolution

        ATM-0850-DISS
	NLT 80% (Q) in 30 minutes 	 	 
	
        Water Content

        USP<921> method 1a
	NMT 6.0% 	 	 
	Residual Solvents 	USP <467> option 1 	Complies 	 
	Elemental Impurities 	Meets USP <232> and <233> requirements 	Complies 	 



 



    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.


    

SCHEDULE B


 


PRODUCT SPECIFICATIONS


 


Elite Pharmaceuticals Inc.


FINISHED PRODUCT ANALYSIS 


	Trimipramine Maleate Capsules Equivalent to 50mg of Trimipramine	Number: SP0851
	
        Manufacturer:

        Elite Laboratories, Inc
	
        DEPARTMENT:

        ANALYTICS AND QC
	Version: 1	Item Code: 0851
	QC#:	Batch #:	
        Manufacturing Date:

         

        Expiration Date:
	 


 


	Test / Method 	Specification 	Results 	Reference 
	Appearance Visual 	
        #2 Capsules, light blue opaque cap, medium orange
        opaque body, imprinted “A-294” in black ink on cap
        and body, filled with white to off-white powder	 	 
	
        Identification

        A. HPLC

        ATM-0850-ASCU
	The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay 	 	 
	
        Identification

        B. Ultraviolet Absorption

        ATM-0850-ASCU
	The UV spectrum of the Sample solution exhibits maxima only at the same wavelength as those obtained from that of standard solution, as obtained in the Assay 	 	 
	
        Assay

        ATM-0850-ASCU
	90.0% -110.0% 	 	 
	Uniformity of Dosage Units by Content Uniformity ATM-0850-ASCU 	Meets USP <905> requirements 	 	 
	Organic Impurities ATM-0850-IMP 	
        a. Iminodibenzyl:
        NMT 0.2%

        b. Imipramine:
        NMT 0.2%

        c. Dehydro
        Trimipramine: NMT 0.2%

        d. Single
        Largest Individual Unspecified Impurity:

        NMT 0.1%

        e. Total
        Known and Unknown Impurities: NMT 0.5%
	 	 
	
        Dissolution

        ATM-0850-DISS
	NLT 80% (Q) in 30 minutes 	 	 
	
        Water Content

        USP<921> method 1a
	NMT 6.0% 	 	 
	Residual Solvents 	USP <467> option 1 	Complies 	 
	Elemental Impurities 	Meets USP <232> and <233> requirements 	Complies 	 



 



    4


    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 B


 


PRODUCT SPECIFICATIONS


 


Elite Pharmaceuticals Inc.


FINISHED PRODUCT ANALYSIS 


	Trimipramine Maleate Capsules Equivalent to 100mg of Trimipramine	Number: SP0852
	
        Manufacturer:

        Elite Laboratories, Inc
	
        DEPARTMENT:

        ANALYTICS AND QC
	Version: 1	Item Code: 0852
	
        QC#:

         
	
        Batch #:

         
	
        Manufacturing Date:

         

        Expiration Date:
	 


 


	Test / Method 	Specification 	Results 	Reference 
	Appearance Visual 	#2 Capsules, light blue opaque cap, white opaque body, imprinted “A-295” in black ink on cap and body, filled with white to off-white powder 	 	 
	
        Identification

        A. HPLC

        ATM-0850-ASCU
	The retention time of the major peak of the Sample solution corresponds to that of the Standard solution, as obtained in the Assay 	 	 
	
        Identification

        B. Ultraviolet Absorption

        ATM-0850-ASCU
	The UV spectrum of the Sample solution exhibits maxima only at the same wavelength as those obtained from that of standard solution, as obtained in the Assay 	 	 
	
        Assay

        ATM-0850-ASCU
	90.0% -110.0% 	 	 
	Uniformity of Dosage Units by Content Uniformity ATM-0850-ASCU 	Meets USP <905> requirements 	 	 
	Organic Impurities ATM-0850-IMP 	
        a. Iminodibenzyl:
        NMT 0.2%

        b. Imipramine:
        NMT 0.2%

        c. Dehydro
        Trimipramine: NMT 0.2%

        d. Single
        Largest Individual Unspecified Impurity:

        NMT 0.1%

        e. Total
        Known and Unknown Impurities: NMT 1.5%
	
         

         
	 
	
        Dissolution

        ATM-0850-DISS
	NLT 80% (Q) in 30 minutes 	 	 
	
        Water Content

        USP<921> method 1a
	NMT 6.0% 	 	 
	Residual Solvents 	USP <467> option 1 	Complies 	 
	Elemental Impurities 	Meets USP <232> and <233> requirements 	Complies 	 


 




    5


    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 B


 


PRODUCT SPECIFICATIONS


 


Elite Pharmaceuticals Inc.


FINISHED PRODUCT ANALYSIS 


	Isradipine Capsules USP 2.5 mg	 	Number: SP0910
	
        Manufacturer:

        Elite Laboratories, Inc
	
        Department:

        Analytics and QC
	Version 1	Item Code: 0910
	QC#:	Batch #:	
        Manufacturing Date:

         

        Expiration date:



 


	Test / Method 	Specification 	Results 	Notebook Reference 
	Description Visual	White opaque capsules with imprint “A263” on cap and body filled with yellow colored powder	 	 
	
        Ultraviolet Absorption

        Identification

        USP <197U>

        25μg/mL in methanol

        Cell Size: 1 cm

        Range: 250-450nm
	The maxima obtained with the sample preparation corresponds with that of standard preparation	 	 
	
        Chromatographic

        Identification

        ATM-0910-ASCU
	The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in Assay	 	 
	
        Assay

        ATM-0910-ASCU
	90.0% -110.0% of the labeled amount of isradipine	 	 
	
        Uniformity of Dosage

        (Content Uniformity)

        ATM-0910-ASCU
	
        Meets USP <905>

        Acceptance Value ≤ 15.0
	 	 
	
        Related Substances

        (Impurities/Degradants)

        ATM-0910-IMP
	
        a. Impurity
        C: NMT 0.2%

        b. Impurity
        A: NMT 0.3%

        c. Impurity
        D or USP related compound A: NMT 0.2%

        d. Impurity
        B: NMT 0.3%

        e. Impurity
        F: NMT 0.15%

        f. Isradipine
        Ethyl-Isopropyl: NMT 0.15%

        g. Each
        Unknown Related Substances: NMT 0.10%

        h. Total
        (Known and Unknown): NMT 1.2%
	 	 
	
        Dissolution

        ATM-0910-DISS
	Not less than 75% (Q) of labeled amount of isradipine is dissolved in 45 minutes	 	 
	Water Determination USP <921>	Not more than 8.0%	 	 
	Residual Solvents	USP<467> option 1	Complies	Refer to Certification
	Elemental Impurities	Meets USP <232> and <233> requirements	Complies	 


1


 




    6


    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 B


 


PRODUCT SPECIFICATIONS


 


Elite Pharmaceuticals Inc.


FINISHED PRODUCT ANALYSIS 
 	Isradipine Capsules USP 5 mg	 	Number: SP0911
	
        Manufacturer:

        Elite Laboratories, Inc
	
        Department:

        Analytics and QC
	
        Version 1
	Item
Code: 0911
	QC#: 	Batch #: 	
        Manufacturing Date:

         

        Expiration date:



 


	Test / Method 	Specification 	Results 	Notebook Reference 
	Description Visual 	Flesh opaque capsules with imprint “A264” on cap and body filled with yellow colored powder 	 	 
	
        Ultraviolet Absorption

        Identification

        USP <197U>

        25μg/mL in methanol

        Cell Size: 1 cm

        Range: 250-450nm
	The maxima obtained with the sample preparation corresponds with that of standard preparation 	 	 
	
        Chromatographic

        Identification

        ATM-0910-ASCU
	The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the Standard preparation, as obtained in Assay 	 	 
	
        Assay

        ATM-0910-ASCU
	90.0% -110.0% of the labeled amount of isradipine 	 	 
	
        Uniformity of Dosage

        (Content Uniformity)

        ATM-0910-ASCU
	
        Meets USP <905>

        Acceptance Value ≤ 15.0
	 	 
	
        Related Substances

        (Impurities/Degradants)

        ATM-0910-IMP

         
	
        a. Impurity
        C: NMT 0.2% 

        b. Impurity
        A: NMT 0.3% 

        c. Impurity
        D or USP related compound A: NMT 0.2% 

        d. Impurity
        B: NMT 0.3% 

        e. Impurity
        F: NMT 0.15% 

        f. Isradipine
        Ethyl-Isopropyl: NMT 0.15% 

        g. Each
        Unknown Related Substances: 

NMT 0.10% 

        h. Total
        (Known and Unknown): NMT 1.2% 
	
         

         
	 
	
        Dissolution

        ATM-0910-DISS
	Not less than 75% (Q) of labeled amount of isradipine is dissolved in 45 minutes 	 	 
	Water Determination USP <921> 	Not more than 8.0% 	 	 
	Residual Solvents 	USP<467> option 1 	Complies 	Refer to Certification 
	Elemental Impurities 	Meets USP <232> and <233> requirements 	Complies	 


 




    7


    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.


    

 


		3.	Post termination of Glenmark’s license right under this Agreement to sell Methadone and Phendimetrazine, Glenmark will
be permitted to sell its remaining inventory of Methadone and Phendimetrazine per Section 8.4 of the Agreement and Elite will continue
to receive License Fees per Section 3.3, however Glenmark agrees not to apply any negative License Fees (profit losses) to Elite’s
profit split with respect to Methadone or Phendimetrazine sold on or after October 1, 2019.



		4.	Parties have agreed that Elite shall not hold Glenmark liable to pay for any remaining Methadone or Phendimetrazine raw materials
and packaging materials procured or ordered in Elite’s inventory as of December 31, 2019.



		5.	Further all consequential changes stand incorporated in the Agreement to effect the aforesaid change.



		6.	This Amendment shall be an integral part of the Agreement.



 


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.	 	Glenmark Pharmaceuticals Inc., USA
	 	 	 	 	 
	By:	/s/ Nasrat Hakim	 	By:	/s/ Sanjeev Krishan
	Name:	Nasrat Hakim	 	Name:	Sanjeev Krishan
	Title:	President and CEO	 	Title:	EVP
	Date:	1-2-20	 	Date:	14-1-20


 


	Elite Laboratories, Inc.	 
	 	 	 
	By:	/s/ Nasrat Hakim	 
	Name:	Nasrat Hakim	 
	Title:	President and CEO	 
	Date:	1-2-20	 


 




 


8