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Exhibit 10.1
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MASTER DEVELOPMENT AND LICENSE AGREEMENT FOR PRODUCTS BETWEEN ELITE PHARMACEUTICALS, INC. AND MIKAH PHARMA LLC
This DEVELOPMENT AND LICENSE AGREEMENT (the “Agreement”), dated June 10, 2021 (the “Effective Date”) between Mikah Pharma LLC, 00 Xxxxxx Xxxxx, Xxxxxxxxxxxx, XX 00000, XXX (“Mikah”) and Elite Laboratories, Inc. (a subsidiary of Elite Pharmaceuticals, Inc.), organized under the laws of the State of Delaware, with offices at 000 Xxxxxx Xxxxxx, Xxxxxxxxx, Xxx Xxxxxx, XXX (“Elite”); Mikah and Elite may sometimes hereinafter be referred to as a “Party” or collectively as the “Parties”.
ARTICLE 1
The following terms shall have the meanings set forth in this Agreement:
1.1 | “Affiliate” shall mean any person or entity, which, directly or indirectly, controls, is controlled by, or is under common control with, a party or its assignee. Control shall be determined based upon either their legal right to control or de facto control of the entity. |
1.2 | “Agreement” shall have the meaning set forth in the Preamble and shall include any exhibits and attachments hereto. |
1.3 | “ANDA” shall mean Abbreviated New Drug Application pursuant to the applicable part of FD&C Act, and any supplements and amendments thereto which may be filed by the Parties. |
1.4 | “API” shall mean the active pharmaceutical ingredient. |
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1.5 | “Applicable Laws” shall mean all laws, ordinances, codes, rules and regulations applicable to the manufacturing of the Product or any aspect thereof in the Territory and the obligations of Elite or Mikah, as the context requires under this Agreement, including, without limitation: (i) all applicable federal, state and local laws and regulations of the Territory (including Environmental Laws); (ii) the U.S. Federal Food, Drug and Cosmetic Act, and (iii) the Regulations promulgated under the FD&C Act including without limitation those regarding cGMP, each as amended from time to time and (iv) all laws ordinances, codes, rules and regulations applicable to Elite as they apply to the Products. |
1.6 | “CMC” means - Chemistry, Manufacturing, and Controls under the FD&C Act. |
1.7 | “Competitive Product” shall mean a product which addresses the same therapeutic indication as a Product, contains the same active pharmaceutical ingredient as a Product and references the same reference listed drug (RLD) in its ANDA. |
1.8 | “Data” shall refer to all data, materials, plans, reports, test results and other information developed in connection with the Products. |
1.9 | “Facility” shall mean Elite’s finished product manufacturing facility located at 000 Xxxxxx Xxxxxx, Xxxxxxxxx, Xxx Xxxxxx or any other facility jointly approved by the Parties, and associated costs shall be shared equally by the Parties. |
1.10 | “FDA” shall mean the United States Food and Drug Administration. |
1.11 | “FD&C Act” shall mean the United States Federal Food, Drug and Cosmetics Act, (21 U.S.C. 301, et seq.), as amended from time to time, and any regulation promulgated thereunder, including, without limitation, all current Good Manufacturing Practices and current good laboratory practices as defined therein, in each case, as amended from time to time. |
1.12 | “Force Majeure” shall mean the occurrence of an event which materially interferes with the ability of a Party to perform its obligations or duties hereunder which is not within the reasonable control of the Party affected, not due to malfeasance, and which could not with the exercise of due diligence have been avoided, including, but not limited to, fire, accident, work stoppage, sabotage, strike, riot, civil commotion, terrorism, act of God or change in law. |
1.13 | “GDUFA Facility Fees” shall mean the annual facility fees required under the Generic Drug Users Fee Act. |
1.14 | “Good Manufacturing Practices” or “cGMP” shall mean the current good manufacturing practices for manufacturing finished products and active pharmaceutical ingredients as set forth in the FD&C Act, their attendant rules and regulations, and any other current good manufacturing practices which are applicable to the Facility. |
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1.15 | “Know-How” means proprietary know-how, trademarks, inventions, data, technology, and information relating to Product, which either Party hereto has the lawful right to disclose to the other Party. “Know-How” shall include, without limitation, processes and analytical methodology used in development, testing, analysis and manufacture and medical, clinical, toxicological testing as well as other scientific data relating to Product. |
1.16 | “Product” means products as listed in Exhibit A. |
1.17 | “Regulatory Filings” means filings with the FDA such as the ANDA. |
1.18 | “Regulatory Approvals” shall mean the approvals required under the FD&C Act to sell and market the Product in the Territory. |
1.19 | “Specifications” with respect to the Product shall mean the development, manufacturing, quality control, packaging, labeling, shipping and storage specifications in the applicable USP-NF (United States Pharmacopeia- National Formulary), monograph, the Drug Master File or other Regulatory Filing, in the form of specifications set forth as part of this Agreement, and such specifications as may from time to time be established by applicable Regulatory Authorities and as mutually agreed upon by the Parties. |
1.20 | “Termination Event” has the meaning set forth in Section 10.1. |
1.21 | “Territory” means the United States of America, its territories, possessions, commonwealths. |
ARTICLE 2
2.1 | Product Development. The roles and responsibilities of each of the Parties in the development of the Products are outlined in Exhibit C. |
ARTICLE 3
3.1 | Elite will be responsible for engaging a third party to market and sell the Products using the third-party label by Product. Elite shall be responsible or ensure the third party engaged to market and sell, is responsible for all permits, licenses, and distribution costs and for complying with all regulations and applicable laws and permits required to file the Product in the Territories. Mikah shall be a party to the sales agreements with third parties. |
3.2 | Trademarks. The Parties agree and acknowledge that they shall not acquire by virtue of this Agreement any interest in any trademarks or trade names of the other Party. |
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ARTICLE 4
ARTICLE 5
MANUFACTURING AND SUPPLY OF PRODUCT
ARTICLE 6
6.1 | Elite and Mikah agree that cost sharing and profit sharing shall be in accordance with Exhibit B. |
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ARTICLE 7
REPRESENTATIONS, WARRANTIES AND COVENANTS
7.1 | Representations and warranties: |
(a) | Each Party represents and warrants to the other that it is authorized to enter into and to perform its obligations under this Agreement. | |
(b) | Each Party represents and warrants to the other that its obligations created under this Agreement do not conflict in any manner with any of its pre-existing obligations. | |
(c) | Each Party represents and warrants to the other that it is the owner of any Know-How to be used or relied upon by such Party in performing its obligations under this Agreement. | |
(d) | Both Mikah and Elite represent and warrant that: |
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(i) | it has not received any notice or claim that the use of its Know-How infringes any patent or intellectual property rights of any third party in the Territory; and | |
(ii) | to its actual knowledge, without any independent investigation, the use of its Know-How will not infringe any patent or intellectual property rights of any third party in the Territory. |
(e) | Each Party hereby represents and warrants that it is not in violation of any law or regulation, nor is it aware of any violation of any law or regulation by any other Person, which violation could reasonably be expected to adversely affect its performance of its obligations hereunder, and except as otherwise contemplated hereby, such Party holds each of the licenses, permits, approvals or authorizations necessary with respect to its current business and operations (and its rights and obligations contemplated hereby) in compliance with all laws and regulations and maintains compliance with cGMP. |
7.2 | Non-Competition. |
(a) | Mikah hereby covenants and agrees that without the prior written consent of Elite during the Term of this Agreement, Mikah will not directly or indirectly market a Competitive Product. Mikah will not engage in any R&D development, manufacturing, or contract manufacturing activities of a Competitive Product for any of its affiliates or third party. | |
(b) | Elite hereby covenants and agrees that without the prior written consent of Mikah during the Term of this Agreement, Elite will not directly or indirectly market a Competitive Product. Elite will not engage in any R&D development, manufacturing, or contract manufacturing activities of a Competitive Product for any of its affiliates or third party. |
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ARTICLE 8
8.1 | Elite shall be responsible for the patent reviews. Out-of-pocket costs, if required, will be shared equally. |
8.2 | With respect to any Product developed hereunder, the Parties shall jointly own the Know-how and Intellectual Property. Elite shall be responsible for filing and prosecuting the patents, defending the patents against infringement and defending patent infringement claims brought by others. Out-of-pocket costs, if required, will be shared equally. Each Party shall promptly render all necessary assistance reasonably requested by the other Party in applying for and prosecuting patent applications in the US relating to such Party’s Know-How under this Agreement. US Patent Law shall determine ownership of inventions. |
ARTICLE 9
(a) | Any breach by Elite or default by Elite in the performance of, or any failure on the part of Elite to observe, perform or abide by, any restriction, covenant, obligation, representation, warranty, or other provision contained in this Agreement or | |
(b) | Any injury or alleged injury to any person (including death) or to the property of any person not a party hereto arising out of or alleging the negligence or intentional act or omission of Elite or its employees or agents failing to perform their duties under the Agreement. |
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(a) | Any breach by Mikah or default by Mikah in the performance of, or any failure on the part of Mikah to observe, perform or abide by, any restriction, covenant, obligation, representation, warranty, or other provision contained in this Agreement or | |
(b) | Any injury or alleged injury to any person (including death) or to the property of any person not a party hereto arising out of or alleging the negligence or intentional act or omission of Mikah or its employees or agents failing to perform their duties under the Agreement. |
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ARTICLE 10
TERM AND TERMINATION AND DEFAULT
(a) | Failure by either Party hereto to perform fully, or comply fully, with, any material provision of this Agreement and such failure continues for a period of sixty (60) days after receipt of written notice of such nonperformance or noncompliance; | |
(b) | Failure of either Party to pay any amount due to other Party, which failure continues for a period of sixty (60) days after written notice of such non-payment unless, and to the extent such non-payment is due to a good faith dispute concerning the amount owed. |
ARTICLE 11
RESOLUTION OF DISPUTES; ARBITRATION
11.1 | The following dispute resolution process shall apply to all disputes that arise under this Agreement (the “Dispute Resolution Process”). In the event of any dispute under this Agreement, the disputing Party shall provide written notice of the dispute to the other Parties detailing such dispute. Within ten (10) business days from the date of the written notice, the Parties will meet at a mutually acceptable time and place or via phone or teleconference, and thereafter as often as they reasonably deem necessary, to exchange relevant information and to attempt to resolve the dispute. If they are unable to resolve the dispute within fifteen (15) business days of their first meeting, the matter shall be referred to a senior board level manager of each of the Parties. |
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11.2 | If the senior board level managers of the Parties are unable to resolve the matter within three (3) business days after notification then, any Party to the dispute may initiate binding arbitration in accordance with the Commercial Arbitration Rules of the American Arbitration Association; such arbitration to be held in New Jersey on an expedited basis. |
11.3 | Expenses. Each Party shall be responsible for its own legal fees, travel, and related expenses during the Parties’ attempt to resolve the dispute. |
11.4 | Other Rights. Nothing in this Section 11 shall be deemed to waive the right of any Party to apply to a court of competent jurisdiction for a temporary restraining order, a preliminary injunction, or other equitable relief to preserve the status quo or prevent irreparable harm. |
ARTICLE 12
(a) | The obligations of confidentiality set forth in Section 12.5 of Article 12 shall survive; | |
(b) | The Parties obligations under Article 9 shall survive; and | |
(c) | Any cause of action or claim of Mikah or Elite accrued or to accrue because of any breach or default by the other Party hereunder shall survive. |
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(i) | Information which is known to the receiving Party or one of its Affiliates or independently developed by the receiving Party or one of its Affiliates prior to the time of disclosure, in each case, to the extent evidenced by written records; | |
(ii) | Information disclosed to the receiving Party by a third party, which has a right to make such disclosure; | |
(iii) | Information which is or becomes patented, published or otherwise part of the public domain as a result of acts by the disclosing Party or a third person obtaining such information as a matter of right; or | |
(iv) | Information which is required to be disclosed by order of the FDA or similar authority in other countries or a court of competent jurisdiction; provided that the Parties shall use their best efforts to obtain confidential treatment of such information by the court or agency. |
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If to Elite, to:
Elite Pharmaceuticals, Inc.
Attn: CFO
000 Xxxxxx Xxxxxx
Xxxxxxxxx, Xxx Xxxxxx 00000
If to Mikah to:
Mikah Pharma LLC
Attn: CEO
00 Xxxxxx Xxxxx
Xxxxxxxxxxxx, XX 00000
Any such notice provided pursuant to this Section 10.11 shall be deemed to have been received by the addressee ten business days following the date of dispatch of the notice or other document by registered mail or, where the notice or other document is sent by overnight delivery service, by hand or is given by facsimile, simultaneously with the transmission or delivery. Notwithstanding the foregoing, any notice or other document sent by overnight delivery service, by hand or by facsimile and received by the recipient after 5:30 p.m. local time (of the recipient) shall be deemed to be delivered the next Business Day. To prove the giving of a notice or other document it shall be sufficient to show that it was dispatched. Either party may change its address at which notice is to be received by written notice provided pursuant to this Section 10.11.
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(Signature Page follows)
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Mikah Pharma LLC | Elite Pharmaceuticals, Inc. | ||
By: | /s/ Xxxxxx Xxxxx | By: | /s/ Xxxx Xxxxxxx |
Name: | Xxxxxx Xxxxx | Name: | Xxxx Xxxxxxx |
Title: | CEO | Title: | CFO |
Date: | Date: |
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Exhibit A
PRODUCTS
The following table lists Products as defined in Section 1.16.
Products | Reference Listed Drug |
[***] | [***] |
[***] | [***] |
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Exhibit B
1. | The Party responsible for marketing and sales shall pay the other Party according to the profit splits below. |
Products | [***] Products | [***] Products |
Elite profit share | [***] | [***] |
Mikah profit share | [***] | [***] |
* Parties jointly own the ANDA
2. | The Party responsible for third party marketing and sales shall determine the Profit Split according to the table below and shall provide a report (the “Report”) providing documentation of the items outlined below. |
Gross Invoice Sales | Invoiced Sales | |
Net Sales | Gross Invoice Sales less the following: cash discounts, charge backs, buying groups/wholesaler administrative fees/rebates, allowances, Medicaid and returns | |
Deductions | Cost of goods sold and [***] of net sales allowance to the third-party doing marketing and sales (or alternative amount mutually agreed upon by the Parties) | |
Profit share to third party (if applicable) | Profit share to third party doing marketing and sales | |
Net Profits | Net Sales less Deductions and third-party profit share | |
Profit Split | Net Profit dollars x profit share |
Profit sharing payments shall be made quarterly. In no case shall the profit share be negative. In the event of a loss in any month, the party doing sales may carry forward the losses to future months until the loss is fully absorbed.
The calculation of Product Gross Profit and the Licensing Fee shall be performed by the Party responsible for marketing and sales and presented to the other Party as a report (“Report”) which shall include the information outlined above.
Whenever possible, the Report will be made using actual sales, charge backs, administrative fees/rebates, price adjustments, and returns as provided by third party marketer and seller; however, in some cases estimated numbers may be required because of timing of charge backs, fees, returns, etc. A true up Report will be completed and presented to each Party within 60 days after the end of each calendar year.
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Exhibit C
ROLES AND RESPONSIBILITIES OF PARTIES
1. | Mikah will be responsible, at its sole cost and expense, for: |
a. | All development work required for the development of an approvable, generic bioequivalent formulation of the Product and; | |
b. | All analytical method development, and; | |
c. | All necessary support for development. | |
d. | Primary responsibility for compiling the Data and documents to ensure writing the CMC section, writing other required sections adequate for the filing of an ANDA. |
2. | Elite will be responsible, at its sole cost and expense, for: |
a. | The facility (FDA and DEA approved) including, but not limited to, equipment, quality assurance and regulatory support. | |
b. | Collaboration with Mikah to transfer the initial formulation and methods, and to support the development process. | |
c. | Execution of QbD. | |
d. | The manufacturing, testing, and packaging of ANDA products required for pilot, pivotal clinical trials, and registration batches. | |
e. | Collaboration with Mikah to transfer all methods. | |
f. | Perform method validation for assay, dissolution, impurity, and cleaning. | |
g. | Perform release testing and; | |
h. | Establish and maintain stability protocols and testing for said ANDA’s. |
3. | Mikah shall be responsible, at its sole cost and expense, for: |
a. | Identifying API for Products |
4. | Elite and Mikah shall equally share [***] for the following: |
a. | The cost of the biostudies. | |
b. | The out-of-pocket development costs including but not limited to excipients (including controlled release polymers) and outside lab costs, if applicable. | |
c. | API costs for the development of Products. |
Elite and Mikah will mutually discuss and agree upon the BE study design and sponsorship.
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