Exhibit
10.44


 


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 GLENMARK PHARMACEUTICALS
INC. USA


  


This
Amendment, dated as of August 1, 2018 (the “Amendment”), by and between 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”) 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
Laboratories, Inc. (a subsidiary of Elite Pharmaceuticals, Inc.) and Glenmark dated May 22, 2018 (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.	Schedule
A of the Agreement shall be replaced in its entirety with new Schedule A listed below:



  


SCHEDULE
A


Products
and Prices 


 


Product
List


 


	Generic Name	ANDA #	Reference Listed Drug	Market exclusivity grant from ELITE
	Phendimetrazine 35 mg tablets	40762	Bontil® (Phendimetrazine Tartrate) Tablets, mfg by Valeant Pharm.	Semi-exclusive
	Methadone 5 mg and 10 mg tablets	TBD	Dolophine® (Methadone HCl USP) Tablets, mfg by West-Ward Pharm.	Exclusive
	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) Capules mfg by GlaxoSmithKline	Exclusive




 


 *
Isradipine license shall begin October 2, 2018  


 



    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 (continued)


Products
and Prices


  


Transfer
Prices ($/bottle)


	Name	Full
    Batch Qty.	Bottle
    Size	Cost
    per bottle
	Phendimetrazine
    35 mg tablet	800,000
    tablets	100
    count	$[***]
	Phendimetrazine
    35 mg tablet	800,000
    tablets	1000
    count	$[***]
	Methadone
    tablet, 5 mg	1,440,000	100
    count	$[***]
	Methadone
    tablet 10 mg	720,000	100
    count	$[***]
	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	$[***]


 


*
Isradipine license shall begin October 2, 2018


 


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 


  


	Methadone Hydrochloride Tablets, USP 5 mg	 	Number: SP0603
	
        Manufacturer:

Elite Laboratories, Inc
	
        Department:

Analytics and QC
	Version 3	Item Code: 0603
	QC#:	Batch #:	
        Manufacturing Date:

Expiration date:





  


	Test / Method 	Specification	Results	Notebook Reference
	Description Visual	White to off-white round tablet with “ELI603” on one side and bisected on the other side	 	 
	
        Chromatographic

        Identification

        ATM-0603-ASCU
	The HPLC retention time of the major peak of the sample preparation corresponds to that of standard solution, as obtained in assay.	 	 
	
        Assay

        ATM-0603-ASCU
	93.0% -107.0% of label claim	 	 
	
         

        Uniformity of Dosage

        (Content Uniformity)

        ATM-0603-ASCU
	
        Stratified Content Uniformity samples will
        be taken from 40 evenly spaced locations

         

        Stage 1:

        Test n=3 from each of the 20 of the 40
        evenly spaced locations (total of 60 samples)

         

        If AV for n=60 is < 15.0, and all individual values are between
        75% and 125%, the process passes Stage 1

         

        Stage 2:

        If AV is > 15.0, test 3 tablets from each of the remaining
        20 stratified locations for Stage 2

         

        If AV is < 15.0 for all 120 tablets
        and all individual values are between 75% and 125 %, the process passes Stage 2
	 	 
	
         

        Impurities/Degradants

        ATM-0603-IMP
	
         

        a.     4-Dimethylamino-2,2-diphenylvaleronitrile
(Valero): NMT 0.15%

        b.    Single
        largest Unknown: NMT 0.2%

        c.    Total
        Impurities/Degradants: NMT 1.2%
	 	 
	
        Dissolution

        ATM-0603-DISS
	Not less than 80% (Q) of label claim in 15 minutes	 	 
	
         

        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 


  


	Methadone Hydrochloride Tablets, USP 10 mg	 	Number: SP0604
	
        Manufacturer:

        Elite Laboratories, Inc
	
        Department:

        Analytics and QC
	Version 3	Item Code: 0604
	QC#:	Batch #:	
        Manufacturing Date:

         

        Expiration date:





   


	Test / Method	Specification	Results	Notebook Reference
	Description Visual	White to off-white round tablet with “ELI604” on one side and bisected on the other side	 	 
	
        Chromatographic

        Identification

        ATM-0603-ASCU
	The HPLC retention time of the major peak of the sample preparation corresponds to that of standard solution, as obtained in assay.	 	 
	
        Assay

        ATM-0603-ASCU
	93.0% -107.0% of label claim	 	 
	
         

        Uniformity of Dosage

        (Content Uniformity)

        ATM-0603-ASCU
	
        Stratified Content Uniformity samples will
        be taken from 40 evenly spaced locations

         

        Stage 1:

        Test n=3 from each of the 20 of the 40
        evenly spaced locations (total of 60 samples)

         

        If AV for n=60 is < 15.0, and all individual values are between
        75% and 125%, the process passes Stage 1

         

        Stage 2:

        If AV is > 15.0, test 3 tablets from each of the remaining
        20 stratified locations for Stage 2

         

        If AV is < 15.0 for all 120 tablets and all individual values
        are between 75% and 125 %, the process passes Stage 2
	
         

         
	 
	
         

        Impurities/Degradants

        ATM-0603-IMP
	
         

        d.    4-Dimethylamino-2,2-diphenylvaleronitrile
(Valero): NMT 0.15%

        e.     Single
        largest Unknown: NMT 0.2%

        f.     Total
        Impurities/Degradants: NMT 1.2%
	 	 
	
        Dissolution

        ATM-0603-DISS
	Not less than 80% (Q) of label claim in 15 minutes	 	 
	
         

        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 


   


	Phendimetrazine Tartrate Tablets USP 35 mg	 	Number: SP0440
	Manufacturer:

Elite Laboratories, Inc	Department: Analytics and QC	Version 0	Item Code: 0440
	QC#:	Batch#:	Manufacturing Date:

Expiration date:




 


	Test I Method	Specification	Results	Notebook Reference
	Description Visual	Yellow round tablets with one face bisected and debossed with 'A" and"327"	 	 
	Identification A USP	The crystals melt between 189°C and 193°C, range does not exceed 2°C	 	 
	Identification B USP <191>	A reddish-pink color produced within 15 minutes	 	 
	
        Chromatographic

        Identification

        ATM-0440-ASCU
	The HPLC retention time of the sample preparation corresponds with the retention time of the Phendimetrazine Tartrate standard preparation in the assay test	 	 
	Assay TM-0440-ASCU	90.0% -110.0%	 	 
	
        Uniformity of Dosage (content Uniformity)

        ATM-0440-ASCU
	Meets USP <905> Acceptance Value s15	 	 
	Related substances (impurities/Degradants) ATM-0440-IMP	
        a. Intermediate I: NMT 0.1%

        b. Intermediate II: NMT 0.1%

        - Any other Unknown Impurity
        : NMT 0.2%

        c. Total Related Substances:
        NMT 1.0%
	 	 
	
        Dissolution

        TM-0440-DISS
	Not less than 70% (Q) in 60 minutes	 	 
	Water Determination ATM-0440-KF	Not more than 6.0%	 	 
	Friability USP <1216>	Not more than 1.0%	 	 
	Residual Solvents	USP<467> option 1	Complies	Refer_to_Certification




  



    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


  


	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 	 




 



    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


   


	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 	 




 



    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.


    




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 	 




 



    8


    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	 




 



    9


    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	 




 



    10


    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.	 	Glenmark Pharmaceuticals Inc., USA
	 	 	 
	By:	/s/ Nasrat
    Hakim	 	By:	 /s/ Robert
    Matsuk
	Name:	 Nasrat Hakim	 	Name:	 Robert Matsuk
	Title:	 President and CEO	 	Title: 	Pres. North America &
    Global API Business
	 	 	 	 	 
	Date:	 	Date:  July 25, 2018




  


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




 


 


11