EXPLANATORY NOTE: [***] INDICATES THE PORTION OF THIS EXHIBIT THAT HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND
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 000 Xxxxxx Xxxxxx, Xxxxxxxxx, Xxx Xxxxxx (“Elite”) and Glenmark Pharmaceuticals Inc. USA, a Delaware corporation located at 000 Xxxxxxxxx Xxxxx, Xxxxxx, Xxx Xxxxxx 00000 (“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: 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/ Xxxxxx Xxxxx | By: | /s/ Xxxxxxx Xxxxxxx | |
| Name: | Xxxxxx Xxxxx | Name: | Xxxxxxx Xxxxxxx | |
| Title: | President and CEO | Title: | EVP | |
| Date: | 1-2-20 | Date: | 14-1-20 | |
| Elite Laboratories, Inc. | ||
| By: | /s/ Xxxxxx Xxxxx | |
| Name: | Xxxxxx Xxxxx | |
| Title: | President and CEO | |
| Date: | 1-2-20 | |
8
