Exhibit 10.85


 


Redacted Version


 


LICENSE AGREEMENT


 






Between


 


Elite Pharmaceuticals, Inc.


 


and


 


Epic Pharma LLC


  


 





 






{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


Confidential







 




    	 



    	 



    

 


Redacted Version


  


LICENSE AGREEMENT


 


This License Agreement (“Agreement”)
is entered into as of the 4th day of June, 2015 by and between EPIC PHARMA LLC,
a Delaware limited liability company (“EPIC”) located at 227-15 N. Conduit Avenue, Laurelton, New York 11413
and ELITE PHARMACEUTICALS, INC., a Nevada corporation and ELITE LABORATORIES, INC. (a subsidiary of Elite Pharmaceuticals, Inc.),
a Delaware corporation (collectively, “ELITE”) located at 165 Ludlow Avenue, Northvale, New Jersey 07647.


 


WHEREAS, ELITE has
ownership rights to product/NDA specified on Schedule A (the “Product” or “Products”), and EPIC wishes
to license from ELITE the right to market and sell the Product on the terms and conditions set forth in this Agreement;


 


NOW, THEREFORE, in
consideration of the mutual covenants and agreements set forth in this Agreement, and for other good and valuable consideration,
the receipt of which is hereby acknowledged, the parties hereto agree as follows:


 


Article 1


GRANT OF LICENSE


 


1.1             
Exclusive Product License. ELITE hereby grants to EPIC an exclusive license (“License” or “Licensing
Rights”) without the right to sublicense, to market and sell the Products as listed in Schedule A in the United States, including
the right to reference the NDA Number, where appropriate, for approval to market the Product in the United States.


 


1.2             
Trademarks. EPIC agrees and acknowledges that it shall not acquire by virtue of this Agreement any interest in any
trademarks or trade names of ELITE, except that ELITE authorizes EPIC to place the ELITE trade names and trademarks on marketing
and packaging materials of the Products during the term of this Agreement. The labeling will incorporate a statement that Products
are manufactured by Elite Laboratories, Inc., 165 Ludlow Avenue, Northvale, NJ 07647 and distributed by Epic Pharma LLC, 227-15
N. Conduit Avenue, Laurelton, New York 11413.


 


1.3             
Regulatory and Pharmacovigilance. EPIC shall be responsible for all regulatory and pharmacovigilance matters related
to these Product.


 


1.4             
Improvements. Any new information, developments, or improvements relating to the Product subject to this Agreement,
and any patent or copyright rights arising from or related thereto (collectively, “Improvements”) will be owned solely
by ELITE but shall be automatically included in the License, and if EPIC develops an Improvement that may be used beyond the Product
which are the subject of this Agreement, then ELITE does now automatically grant a worldwide, non-exclusive, irrevocable, royalty-free
right for EPIC to use the Improvement.


 


 





 






{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


Confidential



 






    	 



    	 



    




 


Redacted Version


 


Article 2





COMPENSATION


 


2.1.           
License Fee, Milestone, and Transfer Cost Payments. In return for the Licensing Rights described in this Agreement,
EPIC shall pay to ELITE the milestone payments (“Milestone Payments”) and a license fee (“License Fee”)
all as specified in Schedule B.


 


2.2.           
Records. EPIC shall keep complete and accurate records of all of the components of the calculations in Appendix B
including sales of the Product and the calculation of all gross invoice sales, cash, discounts, net invoice sales, deductions and
net sales of the Product. ELITE shall have the right, at ELITE’s expense and after thirty (30) days’ prior written
notice to EPIC, through an independent certified public accountant, on a mutually agreeable date, to examine such records at any
time within one (1) year after the due date of the License Fee payments to which such records relate, during regular business hours,
during the term of this Agreement and for twelve (12) months after expiration of the last production lot of Product sold by EPIC,
in order to verify the accuracy of the reports to be made under this Agreement. If the accountant determines that EPIC has under-compensated
ELITE, the findings shall be shared with EPIC. If EPIC agrees that EPIC has not paid ELITE all of the compensation ELITE was entitled
to receive, or it is later determined that EPIC did not pay all of the compensation due to ELITE, then EPIC shall pay the proper
amount of compensation and all costs and expenses incurred by ELITE to hire the accountant and all of the accountant’s expenses,
and all legal expenses, to obtain the appropriate compensation. If EPIC disputes in good faith the accuracy of the results of such
examination, the parties will retain a second independent certified public accountant whose examination will be binding upon both
parties. The if the second independent certified public accountant verifies the findings of the first independent certified public
accountant then EPIC will pay all of the expenses of both independent certified public accountant examinations.


 


2.3.           
Reports. EPIC will provide Reports as described in Schedule B.


 


2.4.           
Payments by EPIC. 


 


(a)       
All Milestone Payments will be made by check and mailed to ELITE within ten (10) days after the payment becomes due.


 


		(b)	The License Fee shall be paid to ELITE in quarterly payments based upon the previous quarterly’s Products that EPIC shipped
to its customers. All License Fee payments shall be made by check and mailed to ELITE within thirty (30) days after the end of
each quarterly. A copy of the Report for the prior quarter will accompany the check.



 


		(c)	A late fee of 1% per month will be accrued for all payments which EPIC fails to pay when due.



 


 





 






{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


Confidential


 







    	 



    	 



    




 


Redacted Version


 


Article 3


MANUFACTURING


 


3.1.           
Manufacturing and Supply Agreement. ELITE shall supply Product to EPIC at cost plus ten percent (10%) and the parties
agree to execute a separate Manufacturing and Supply Agreement (the “Manufacturing Agreement”).


 


3.2.           
 PDUFA Fees and Pediatric Study. Prescription Drug User Fee Act (PDUFA) fees will be paid for at cost out of Net
Product Sales and will be shared {***} by the partners based on the profit split. A pediatric study is required by the FDA for
the Product. The costs of the pediatric study will be paid for at cost out of Net Product Sales and will be shared equally by the
partners based on the profit split.


 


3.3.           
Quality Agreement. In conjunction with the execution of this Agreement, the parties shall execute a Quality Agreement.


  


Article 4 


CONFIDENTIALITY


 


4.1           
Confidential Information. Both
Parties acknowledge that it may be necessary for each to disclose certain technical and proprietary information with respect to
the Product to the other and such disclosures may also include either party’s know-how and intellectually property. For purposes
of this Agreement, the term "Confidential Information" shall mean all such information, but not limited to, inventions,
works of authorship, trade secrets, formula, strategy, patents, trademarks, patent applications or trademark applications or other
intellectual property rights, knowledge, know-how, data, processes, proposed processes, procedures, specifications, tests, forms,
customer lists, employee lists, associate lists and supplier lists, techniques, algorithms, software, programs, designs, drawings,
formula or test data relating to any research project or product, works-in-process, future development, market research, marketing
strategies, information relating to products, proposed products, agreements with proprietary information of third parties and clinical
data and analysis, clinical trials, applications and communications with the United States Food and Drug Administration or other
similar governmental bodies or agencies, or other results, regardless of form (whether written, oral, photographic, electronic,
magnetic, computer or otherwise), treated or designated by the Disclosing Party as confidential or proprietary and relating to
a party’s business, finances, intellectual property or other proprietary rights, Specifications, all technical and/or proprietary
information relating to the Product, information relating to the marketing of, customers, customer lists, and sales as well as
the pricing of Product, and all other written information clearly identified as "Confidential" when submitted by the
disclosing party to the receiving party.


 


 





 






{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


Confidential


 







    	 



    	 



    

 


Redacted Version


 


4.2           
Obligations. Each Party shall
hold in strict confidence any such Confidential Information received from the other and shall not disclose it to anyone, other
than a Party's Representatives or use it for its own benefit or the benefit of others except as may be necessary to fulfill its
obligations hereunder, provided such Party first obtains the prior written consent of the disclosing party. In such case, the Party
requesting such consent of the disclosing party shall cause any person to whom such disclosure may be authorized as aforesaid,
to agree to hold such information in confidence and not to use or disclose same to the same extent as such Party. However, the
foregoing obligations shall not apply to information which the receiving party can demonstrate:


 


		(a)	at the time of disclosure to the receiving party or at the time the receiving party learns of such Confidential Information,
was in the public domain, or which thereafter enters the public domain, through no act or omission of the receiving Party; or



 


		(b)	at the time of disclosure to the receiving Party or at the time the receiving Party learns of such Confidential Information,
was already in the possession of the receiving Party or its Representatives, and was not acquired (i) from the disclosing Party,
or (ii) from another source under an obligation of confidence and/or non-use, as documented by receiving Party’s written
records documenting such knowledge; or



 


		(c)	is hereafter lawfully received by the receiving Party or its Representatives on a non-restricted basis from another source
having rightful possession of such Confidential Information and the legal right to disclose it to the receiving Party as documented
by the receiving Party’s written records; or



 


		(d)	is hereafter independently developed by the receiving Party or its Representatives who is shown not to have received or have
available to him or her any such Confidential Information, as documented by the receiving Party’s written records.



 


4.3           
Additional Obligations. The burden of proving
the applicability of any one or more of the above exceptions shall at all times be with the receiving Party. The mutual obligations
of confidentiality under this Section shall survive expiration or earlier termination of this Agreement. If a receiving Party is
required by a government body or court of law to disclose Confidential Information, the receiving Party agrees, to the extent permitted
by law, to give the disclosing Party reasonable advance notice thereof and to cooperate with the reasonable efforts of disclosing
Party to contest the disclosure or seek an appropriate protective order.


 


 





 






{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


Confidential


 







    	 



    	 



    

  


Redacted Version


 


Article 5


TERM AND TERMINATION


 


5.1.           
Term. This Agreement shall become effective as of the date hereof and shall continue until five (5) years from such
date (the “Initial Term”), unless terminated earlier by mutual agreement of the parties or by one of the parties in
accordance with this Article 5; provided further that the parties shall have the option, by mutual agreement, to extend the Initial
Term of this Agreement for an additional five (5) years (a “Renewal Term” and collectively with the Initial Term, the
“Term”) by the parties exchanging written notice of such election not less than six (6) months prior to the expiration
of the Initial Term.


 


5.2.           
Modification for Lack of Licensing Fees.


 


		(a)	EPIC hereby agrees to exert commercially reasonable efforts and shall devote the same efforts to marketing the Products that
EPIC exerts for its other major pharmaceutical products being marketed in the United States.



 


		(b)	If the License Fee paid to ELITE is less than the amounts listed in Schedule C for each year, then at the end of five year
ELITE may terminate the License granted hereunder to EPIC for the Product. If ELITE desires to terminate the License granted hereunder,
then ELITE shall give EPIC ninety (90) days written notice of the License termination.



 


5.3.           
Termination by Mutual Agreement. The parties may terminate this Agreement any time by mutual written agreement.


 


5.4.           
Termination by Breach. Upon the breach or default in the performance or observance of any of the material provisions
of this Agreement by either Party, when such breach or default is not cured by the Party responsible for the breach or default
within sixty (60) days after written notice by the non-breaching Party, the non-breaching Party may terminate this Agreement upon
an additional thirty (30) days written notice to the breaching Party. termination will be without prejudice to either Party to
recover any and all damages to which it may be entitled, or to exercise any other remedies.


 


5.5.           
Termination by ELITE Upon Bankruptcy or Reorganization of EPIC. If EPIC enters into any proceeding (whether voluntary
or otherwise) in bankruptcy, reorganization or arrangement for the appointment of a receiver or trustee to take possession of its
assets, or any other proceeding under any law for the relief of creditors or makes an arrangement for the benefit of its creditors,
and remains in such proceeding for 30 days, then ELITE shall retain its rights to the Product and may terminate this Agreement
without further payment to EPIC.


 


5.6.           
Licensing Rights upon Termination. Except as otherwise provided in this Agreement, upon termination of this Agreement:
all rights, privileges, and licenses will terminate and revert to ELITE, and EPIC must not thereafter make any use whatsoever of
any confidential information as described in section 3 of this Agreement, except that it is agreed that upon termination notwithstanding
any other terms of this Agreement, EPIC may retain one archival copy to have sufficient information solely to respond to state
and federal regulatory inquiries regarding the Product.


 


 





 






{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


Confidential


 







    	 



    	 



    

 


Redacted Version


 


5.7.           
Accrued Rights. Expiration or termination of this Agreement shall be without prejudice to the right of either Party
to receive all payments accrued and unpaid at the effective date of such expiration or termination, without prejudice to the remedy
of either Party in respect to any previous breach of the representations, warranties or covenants herein contained, without prejudice
to any rights to indemnification set forth herein and without prejudice to any other provision hereof which expressly or necessarily
calls for performance after such expiration or termination. EPIC expressly retains the right to sell Product on-hand after termination
of this Agreement and shall remain bound to pay ELITE the Licensing Fee as provided in this Agreement.


 


Article 6


REPRESENTATIONS, WARRANTIES AND COMPETITION, COOPERATION UPON BANKRUPTCY OF ELITE


 


6.1.        
EPIC Representations. EPIC hereby represents and warrants to ELITE that (a) it has obtained all necessary licenses,
authorizations and approvals required by applicable Law, including those required by the FDA, DEA or any other applicable regulatory
agency to enter into this Agreement and perform its obligations hereunder; (b) the execution, delivery and performance of this
Agreement by EPIC does not conflict with or constitute a breach of any order, judgment, agreement, or instrument to which it is
a party; (c) the execution, delivery and performance of this Agreement by EPIC does not require the consent of any person; and
(d) none of its officers or directors has ever been convicted of a felony under the laws of the United States for conduct relating
to the development or approval of a drug product or relating to the marketing or sale of a drug product


 


6.2.        
ELITE Representations. ELITE hereby represents and warrants to EPIC that (a) it has obtained all necessary licenses,
authorizations and approvals required by applicable Law, including those required by the FDA, DEA or any other applicable regulatory
agency to enter into this Agreement and perform its obligations hereunder; (b) the execution, delivery and performance of
this Agreement by ELITE does not conflict with or constitute a breach of any order, judgment, agreement, or instrument to which
it is a party; (c) the execution, delivery and performance of this Agreement by ELITE does not require the consent of any
person; and (d) none of its officers or directors has ever been convicted of a felony under the laws of the United States
for conduct relating to the development or approval of a drug product or relating to the marketing or sale of a drug product.


 


6.3.        
Non-competition by EPIC. EPIC hereby covenants and agrees that without the prior written consent of ELITE during
the Term of this Agreement, and for two (2) years after the last shipment of Product by EPIC, EPIC will not directly or indirectly
market a product which addresses the same therapeutic indication as the Product, contains the same active pharmaceutical ingredient
as the Product, and has an abuse-deterrent designation in the label.


 


 





 






{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


Confidential


 







    	 



    	 



    

 


Redacted Version


 


6.4.        
Cooperation Upon Bankruptcy Event of ELITE. ELITE shall use, and cause its representatives and affiliates to use,
best efforts to make all necessary arrangements and take all required actions to permit EPIC to retain all rights licensed hereunder
with respect to the Product in the event that ELITE (i) is dissolved or liquidated,
(ii) commences a voluntary case or other proceeding seeking liquidation, reorganization or other relief with respect to
itself or its debts under any bankruptcy, insolvency or other similar
law, (iii) is subject to an involuntary case or other proceeding seeking liquidation,
reorganization or other relief with respect to ELITE and an order for relief entered or such proceeding has not be dismissed or
discharged within sixty (60) days of commencement, (v) has made an assignment for the benefit of creditors, or (vi)
otherwise ceases to conduct business during the Term (each, an “Extraordinary Event”).


 


Article 7


INDEMNIFICATION AND INSURANCE


 


7.1.           
ELITE Indemnity. Subject to Sections 5.2 and 5.4, ELITE shall indemnify and hold harmless EPIC and its Affiliates
against all third party claims, actions, costs, expenses, including court costs and legal fees or other third party liabilities
("Third Party Liabilities") whatsoever in respect of:


 


		(a)	any breach of any representation, warranty, covenant or similar promise made under this Agreement or arising out of this Agreement;



 


		(b)	any negligence or willful misconduct by ELITE and/or any of its employees; and



 


any claim of patent infringement or intellectual
property, trademark or tradedress violation;


 


		(c)	any product liability claims in connection with the Products caused by ELITE or any third party acting on behalf of ELITE or
its Affiliates;



 


		7.1	EPIC Indemnity. Subject to Sections 5.1 and 5.4, EPIC shall indemnify and hold harmless ELITE and its Affiliates against
all Third Party Liabilities whatsoever in respect of:



 


		1)	EPIC’s and/or it Affiliates’, subcontractors’ or suppliers’ failure to comply with the cGMP or applicable
Laws;



 


		i.	the use, marketing, storage, distribution, handling
or sale of the Product after the Effective Date by EPIC or any third party, other than a third party acting on behalf of ELITE
or its Affiliates;



 


 





 






{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


Confidential


 







    	 



    	 



    

 


Redacted Version


 


		ii.	and



 


		iii.	any negligent or wrongful act by EPIC and any breach
by EPIC of any representation or warranty, covenant or similar promise made under this Agreement or arising out of this Agreement.



 


		7.2	Procedures for Indemnification. In the event that a party (the "Indemnified Party") is seeking indemnification
under Sections 6.1 or 6.2, the Indemnified Party shall inform the other party (the "Indemnifying Party") of a
claim as soon as reasonably practicable after the Indemnified Party receives notice of the claim, shall permit the Indemnifying
Party to assume direction and control of the defense of the claim, and shall cooperate as requested by the Indemnifying Party (at
the expense of the Indemnifying Party) in the defense of the claim; provided, however, if the defendants in any such action include
both the Indemnified Party and the Indemnifying Party and the Indemnified Party shall have reasonably concluded that a conflict
may arise between the positions of the Indemnifying Party and the Indemnified Party in conducting the defense of any such action
or that there may be legal defenses available to it that are different from or additional to those available to the Indemnifying
Party, the Indemnified Party shall have the right to select separate counsel to assume such legal defenses and to otherwise participate
in the defense of such action or on behalf of the Indemnified Party. No Indemnifying Party shall, without the prior written consent
of the Indemnified Party, settle or compromise or consent to the entry of judgment with respect to any pending or threatened action
or claim whatsoever, in respect of which indemnification could be sought under Sections 6.1 or 6.2 (whether or not the Indemnified
Party is an actual or potential party thereto), unless such settlement, compromise or consent (i) includes an unconditional release
of the Indemnified Party in form and substance reasonably satisfactory to the Indemnified Party from all liability arising out
of such action or claim and (ii) does not include a statement as to or an admission of fault, culpability or a failure to act by
or on behalf of the Indemnified Party. The Indemnifying Party shall not be liable for settlement of any pending or threatened action
or any claim whatsoever that is effected without its written consent (which consent shall not be unreasonably withheld or delayed).



 


		7.3	Mitigation. In the event of any occurrence which may result in either party becoming liable under Section 7.1 or
Section 7.2, each party shall use its best efforts to take such actions as may be reasonably necessary to mitigate the damages
payable by the other party under Section 7.1 or Section 7.2, as the case may be.



 


		7.4	Limitation of Liability. NOTWITHSTANDING ANYTHING TO THE CONTRARY CONTAINED HEREIN, IN NO EVENT SHALL ANY PARTY, ITS
DIRECTORS, OFFICERS, EMPLOYEES, AGENTS OR AFFILIATES BE LIABLE TO THE OTHER PARTIES FOR ANY CLAIMS RELATED TO LOST PROFITS AND
GOODWILL, WHETHER BASED UPON A CLAIM OR ACTION OF CONTRACT, WARRANTY, NEGLIGENCE, STRICT LIABILITY OR OTHER TORT, OR OTHERWISE,
ARISING OUT OF THIS AGREEMENT.



 


 





 






{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


Confidential


 







    	 



    	 



    

 


Redacted Version


 


		7.5	Insurance. Each party shall maintain commercial general liability insurance through the term of this Agreement upon
launch of the first Product, which insurance shall afford limits of not less than $5,000,000 for each occurrence for personal injury
or property damage liability. Furthermore, each party shall maintain product liability insurance, through the term of this Agreement
upon launch of the first Product and for a period of three (3) years thereafter, which insurance shall afford limits of not
less than $5,000,000 in the aggregate per annum with respect to product and completed operations liability. This insurance shall
be written to cover claims incurred, discovered, manifested, or made during or after the expiration of this Agreement. Each party
shall provide the other with a certificate of insurance evidencing the above and showing the name of the issuing company, the policy
number, the effective date, the expiration date and the limits of liability. The insurance certificate shall further provide for
a minimum of thirty (30) days' written notice to the insured of a cancellation of, or material change in, the insurance. If
a party is unable to maintain the insurance policies required under this Agreement through no fault on the part of such party,
then such party shall forthwith notify the other party in writing and the parties shall in good faith negotiate appropriate amendments
to the insurance provision of this Agreement in order to provide adequate assurances. In the event that either a customer or an
insurer of either party requires such party to increase its insurance limits above the $5,000,000 described above for any policy,
then the other party to this Agreement must also match the required insurance increase, so that the parties to this Agreement are
carrying the same insurance policy limits. It is the express intention of the parties that the parties shall endeavor to avoid
insurance policy limits above $10,000,000.



  


8


 MISCELLANEOUS




 


		8.1	Waiver; Remedies and Amendment. Any waiver by any party hereto of a breach of any provisions of this Agreement will
not be implied and will not be valid unless such waiver is recited in writing and signed by such party. Failure of any party to
require, in one or more instances, performance by the other party or parties in strict accordance with the terms and conditions
of this Agreement will not be deemed a waiver or relinquishment of the future performance of any such terms or conditions or of
any other terms and conditions of this Agreement. A waiver by any party of any term or condition of this Agreement, including this
Section 8.1, shall be valid only if in writing and will not be deemed or construed to be a waiver of such term or condition for
any other term. All rights, remedies, undertakings, obligations and agreements contained in this Agreement will be cumulative and
none of them will be a limitation of any other remedy, right, undertaking, obligation or agreement of any party. This Agreement
may not be amended except in a writing signed by all parties.



 


 





 






{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


Confidential


 







    	 



    	 



    

 


Redacted Version


 


		8.2	Affiliates, Assignment, No Inconsistent Agreements. EPIC may not assign its rights and obligations hereunder without
the prior written consent of ELITE. Neither EPIC nor ELITE will enter into any agreement that is inconsistent with its obligations
hereunder. Notwithstanding the foregoing, either party may assign this Agreement to an acquirer that acquires more than a fifty
(50%) interest in the party.



 


		8.3	Counterparts. This Agreement may be executed in any number of counterparts, each of which when so executed will be deemed
to be an original and all of which when taken together will constitute this Agreement.



 


		8.4	Governing Law; Dispute Resolution; Venue. This Agreement will be governed by and construed in accordance with the laws
of the state of New York without regard to conflict of law or choice of law rules. Any controversy or claim pursuant to this Agreement
or the breach thereof shall be referred for decision forthwith to a senior executive of each Party not directly involved in the
dispute. If no agreement is reached within thirty (30) days of the request by one Party to the other to refer the same to such
senior executive, then such controversy or claim shall be settled by arbitration in accordance with the Commercial Arbitration
Rules of the American Arbitration Association; such arbitration to be held in New York City on an expedited basis. Judgment upon
the award rendered by the Arbitrator(s) may be entered in any court having jurisdiction thereof.



 


		8.5	Headings. The headings set forth at the beginning of the various sections of this Agreement are for convenience and
form no part of the Agreement between the parties.



 


		8.6	Notices. All notices, requests, instructions, consents and other communications to be given pursuant to this Agreement
shall be in writing and shall be deemed received (a) on the same day if delivered in person, by same-day courier or by facsimile,
electronic mail or other electronic transmission, (b) on the next day if delivered by overnight mail or courier, or (c) on the
date indicated on the return receipt, or if there is no such receipt, on the third calendar day (excluding Sundays) if delivered
by certified or registered mail, postage prepaid, to the party for whom intended to the following addresses:



 


	If to EPIC:	 
	 	 
	
        EPIC

        227-15 North Conduit Avenue

        Laurelton, NY 11413

        Attn: President
	 



 


 





 






{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


Confidential


 







    	 



    	 



    

 


Redacted Version


 


	If to ELITE:	 
	 	 
	
        ELITE PHARMACEUTICALS, Inc.

        165 Ludlow Avenue

        Northvale, New Jersey 07647

        Attention: President and CEO
	 


 


		8.7	Notice. Each party may by written notice given to the other in accordance with this Agreement change the address to
which notices to such party are to be delivered.



 


		8.8	Severability. If any provision of this Agreement is held by
a court of competent jurisdiction to be invalid or unenforceable, it will be modified, if possible, to the minimum extent
necessary to make it valid and enforceable or, if such modification is not possible, it will be stricken and the remaining provisions
will remain in full force and effect.



 


		8.9	Survival. The rights and obligations which accrue to a party during the term of this agreement shall survive the termination
of this Agreement.



 


		8.10	Force Majeure. No party to this Agreement will be liable for failure or delay in the performance of any of its obligations
hereunder, if such failure or delay is due to causes beyond its reasonable control including, without limitation, acts of God,
earthquakes, fires, strikes, acts of war, or intervention of any governmental authority, but any such delay or failure will be
remedied by such party as soon as possible after the removal of the cause of such failure or delay.



 


		8.11	Entire Understanding. This Agreement, including the schedules attached hereto, contains the entire understanding relative
to the matters addressed herein, and supersedes all prior and collateral communications, reports, and understandings, if any, between
the parties regarding the matters addressed herein.



 


		8.12	Drafting. The parties have participated jointly in the negotiation and drafting of this Agreement. In the event an ambiguity
or question of intent or interpretation arises, this Agreement shall be construed as if drafted jointly by the parties and no presumption
or burden of proof shall arise favoring or disfavoring any party by virtue of the authorship of any of the provisions of this Agreement.



 


		8.13	Not a Joint Venture. This Agreement does not constitute or create (and the Parties do not intend to create hereby) a
joint venture, pooling arrangement, Partnership, or formal business organization of any kind between and among any of the Parties,
and the rights and obligations of the Parties shall be only those expressly set forth herein. The relationship hereby established
between EPIC and ELITE is solely that of licensee and licensor, each is an independent contractor engaged in the operation of its
own respective business. Neither Party shall be considered to be an agent of the other for any purpose whatsoever. Each Party shall
be responsible for providing its own personnel and workers compensation, medical coverage or similar benefits and shall be solely
responsible for the payment of social security benefits, unemployment insurance, pension benefits, withholding any required amounts
for income and other employment-related taxes and benefits of its own employees, and shall make its own arrangements for injury,
illness or other insurance coverage to protect itself, its Affiliates, its subcontractors and personnel from any damages, loss
and/or liability arising out of the performance of this Agreement. Neither Party has the power or authority to act for, represent
or bind the other (or its Affiliates) in any manner.



 


 





 






{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


Confidential


 







    	 



    	 



    

 


Redacted Version


 


IN WITNESS WHEREOF,
the parties have executed this Agreement on the date first set forth above.


 


	ELITE PHARMACEUTICALS, INC.	 	EPIC PHARMA LLC
	 	 	 
	By:  	 	 	By:	 
	 	 	 
	
        Name: Nasrat Hakim
		
        Name: Ashok Nagalye

	 	 	 
	
        Title: CEO and President
	 	
        Title: CEO

	 	 	 
	Date:  	 	 	Date:  	 



 


 





 






{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


Confidential


 




    	 



    	 



    

 


Redacted Version


 


SCHEDULE A


 


Product List


 


	Name	NDA #
	{***} with sequestered naltrexone capsules with strengths of {***}	To be determined


 


 





 






{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


Confidential


 





    	 



    	 



    

 


Redacted Version


 


SCHEDULE B


 


Compensation
for Licensing Rights


 


Milestone Payments


 


EPIC shall pay to ELITE
Milestone Payments equal to fifteen million dollars ($15,000,000) in compensation for Elite’s R&D costs.


		·	{***} ({***})
shall be paid to Elite upon signing the agreement to be used for clinical studies including a bunionectomy.



		·	{***} ({***}),
covering ELI-200 R&D expenses which expenses shall be documented and provided to Epic prior to the following payments: {***}
Dollars upon filing of the NDA;



		·	{***} Dollars upon receipt of the approval letter for
the NDA from the Food and Drug Administration.



 


·         All
milestone payments shall be non-refundable and shall be credited towards research and development costs for ELI-200. Elite shall
document the ELI-200 research and development costs paid for by these milestones including but not limited to manufacturing of
clinical lots and registration batches, Bio-Equivalence studies, Methods Development, Analytical and Stability testing, Process
Development costs, Human Abuse Liability Clinical Trials, Withdrawal Studies and Regulatory Costs etc.


 


License Fee


 


EPIC will pay to ELITE a License Fee of {***}%
of Product Net Sales (“Product Net Sales”) of EPIC, as defined below, generated on Product sold and shipped to its
customers by EPIC.


 


Net Sales is defined as: Net Invoice Price less the following:
Charge backs, Buying Groups/Wholesaler Administrative Fees/Rebates, Allowances, Medicaid and Returns.


 


The calculation of Product Gross Profit and the Licensing Fee
shall be performed by Epic and presented to Elite as a report (“Report”) which shall include the following information:


 


 





 






{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


Confidential


 





    	 



    	 



    

 


Redacted Version


 


SCHEDULE B (cont’)


 


REPORT ITEMS


 


	Gross Invoice Sales	 	Total Sales for Month
	Cash Discount	 	Cash Discount 
	Net Invoice Sales	 	Total Sales - Cash Discount
	 	 	 
	Deductions 	 	Allowances including Medicaid rebate; state program rebates, price adjustments; returns, charge backs and GOGS
	Net Sales	 	Net Invoice Sales – Deductions
	Marketing Costs	 	Less {***}% of the Gross Sales 
	Amount Due 	 	Net Sales dollars x {***}% ({***}% after payments of R&D/Development cost)


 


Whenever possible, the Report will be made using actual sales,
charge backs, administrative fees/rebates, price adjustments, and returns; 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 ELITE within 60 days
after the end of each calendar year.


 


 





 






{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


Confidential


 





    	 



    	 



    

 


Redacted Version


 


SCHEDULE C


 


Minimum Annual License Fee Paid to Elite


 


Epic to comply with the following minimum
License Fee amounts each year post Product launch


 





	 	Year 1 	Year 2	 Year 3 	Year 4 	Year 5
	($ million)	 	 	 	 	 
	Product	 ${***} M	${***} M	 ${***} M	 ${***} M	 ${***} M







 


 





 






{***} Confidential portions of this
exhibit have been redacted and filed separately with the Commission pursuant to a confidential treatment request in accordance
with Rule 24b-2 of the Securities Exchange Act of 1934, as amended.


Confidential