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...
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 ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ (“Elite”) and Glenmark Pharmaceuticals Inc. USA, a Delaware corporation located at ▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇ (“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 ▇▇▇▇-▇▇▇▇ 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: |
Department: |
Version 3 | Item Code: 0603 |
| QC#: | Batch #: |
Manufacturing 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/ ▇▇▇▇▇▇ ▇▇▇▇▇ | By: | /s/ ▇▇▇▇▇▇ ▇▇▇▇▇▇ | |
| Name: | ▇▇▇▇▇▇ ▇▇▇▇▇ | Name: | ▇▇▇▇▇▇ ▇▇▇▇▇▇ | |
| Title: | President and CEO | Title: | Pres. North America & Global API Business | |
| Date: | Date: July 25, 2018 | |||
| Elite Laboratories, Inc. | ||
| By: | /s/ ▇▇▇▇▇▇ ▇▇▇▇▇ | |
| Name: | ▇▇▇▇▇▇ ▇▇▇▇▇ | |
| Title: | President and CEO | |
| Date: | ||
11