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