Exhibit 10.46


 





 


July 20, 2015


 


S. Venkatesh


President


Ascend Laboratories, LLC


180 Summit Avenue, Suite 200


Montvale, NJ 07645


 


		Re:	Third Amendment to TPN-Elite Manufacturing and Supply Agreement dated June 23, 2011 and First Amendment
to TPN-Elite Manufacturing and Supply Agreement dated September 21, 2012 and Second Amendment to TPN-Elite Manufacturing and Supply
Agreement dated January 19, 2015



 


Mr. Venkatesh,


 


The PharmaNetwork,
LLC, a New Jersey limited liability company and its wholly owned subsidiary, Ascend Laboratories, LLC (together "TPN"),
and Elite Pharmaceuticals, Inc., a Nevada corporation, and Elite Laboratories, Inc. (a subsidiary of Elite Pharmaceuticals, Inc.),
a Delaware corporation (together "ELITE") are parties to a Manufacturing and Supply Agreement effective as of June 23,
2011 and a First Amendment of the Manufacturing and Supply Agreement dated September 21, 2012 and to a Second Amendment to TPN-Elite
Manufacturing and Supply Agreement dated January 19, 2015 (together the “Agreement”). All capitalized terms used without
definition in this letter agreement have the respective meanings provided in the Agreement.


 


Effective as of the
date of this letter agreement, the parties agree that Section 3.2 of the Agreement shall be deleted; Section 2.1 (h) and 3.3 shall
be added; and Sections 7.1, 7.3, 10.3, Exhibit A, Exhibit B and sections 4.7 and Appendix 2 of Exhibit C (The Quality Agreement
between the parties) are amended in their entirety and, as amended, read as follows:


 


165 Ludlow Avenue • Northvale, NJ 07647
• Ph: (201)750-2646 • Fax: (201)750-2755 www.elitepharma.com


{***} 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.


 




     


     


    

 


Section 2.1 (h)      Discontinuation of Packaging and Labeling.
Beginning on or about August 1, 2015 ELITE shall supply Product as bulk tablets. Ascend (or a third party responsible to Ascend)
shall be responsible for any use of the bulk tablets including but not limited to finished product packaging, labeling and finished
product release. After discontinuation of packaging and labeling, Elite shall invoice Ascend and Ascend shall pay for any packaging
and labeling materials previously purchased for Product under the previous agreement and that cannot be otherwise used by ELITE
or deployed to other customers of ELITE; or Ascend shall ask Elite to continue packaging until such material is depleted. For the
avoidance of doubt, Product shall be defined as Methadone Hydrochloride Bulk Tablets, USP 10 mg pursuant to the terms of the ANDA
# 090635 (the “Product”).


 


Section 3.3           Placebo
batch and stability. Elite shall make a placebo batch for Ascend at no charge, to be used for a shipping study and Elite shall
complete stability testing for one packaged batch to qualify the new packager for which Elite shall not charge Ascend for the
stability testing.


 


Elite shall continue conducting annual
batch stability studies at no additional charge to Ascend. One packaged batch annually shall be sent by Legacy to Elite for controlled
temperature storage and testing as per the approved stability protocol.


 


Section 7.1           Term. The initial
term (the “Initial Term”) of this Agreement shall commence on the Effective Date and shall continue until December
31, 2016; thereafter, the term of this Agreement shall be extended for one (1) year terms (each a “Renewal Term”)
upon the mutual written agreement of the Parties entered into at least six (6) months prior to the expiration of the Initial Term
or a Renewal Term.


 


Section 7.3           Consequences of Termination


 


(a)          On termination
or expiry of the Agreement for any reason ELITE shall:


 


(i)          ensure
that any copies of TPN’s confidential information, or any information of a technical nature relating to the Product or its
manufacture and supplied by TPN to ELITE are promptly returned to TPN or, at TPN’s option, destroyed;


 


(ii)          promptly
invoice and TPN shall promptly pay an amount equal to the cost of any pharmaceutical or packaging materials (that cannot be otherwise
used by ELITE or deployed to other customers of ELITE) and Product, in ELITE’s possession, provided that, ELITE can prove
by documentary evidence that such pharmaceutical or packaging materials and Product:


 


(1)          were purchased in reliance
on TPN’s’ forecast for the Firm Period; and


 


(2)          are in compliance with
all relevant Product Specifications and otherwise fit for commercial use.


 


165 Ludlow Avenue • Northvale, NJ 07647
• Ph: (201)750-2646 • Fax: (201)750-2755 www.elitepharma.com


{***} 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.


 




     


     


    

 


(b)          The termination or expiry of this Agreement shall not release either of the Parties from any liability which at the time of termination
or expiry has already accrued to the other Party, nor affect in any way the survival of any other right, duty or obligation of
the Parties which is expressly stated elsewhere in this Agreement to survive such termination or expiry.


 


Section 10.3        Notices. Except
as otherwise specifically provided, any notice or other documents to be given under this Manufacturing Agreement shall be in writing
and shall be deemed to have been duly given if sent by registered mail, nationally recognized overnight delivery service or facsimile
transmission to a Party or delivered in person to a Party at the address or facsimile number set out below for such Party or such
other address as the Party may from time to time designate by written notice to the other:


 


If to ELITE: Elite Pharmaceuticals, Inc.


 


165 Ludlow Avenue


Northvale, NJ 07647


Attention: Nasrat Hakim, President and CEO


Facsimile: 201-750-2755


 


With a copy to:


Silverman Sclar Shin & Byrne PLCC


381 Park Avenue South


New York, New York 10016


Attn: Richard Feiner


Facsimile: 917-720-0863


 


If to TPN/Ascend:


Ascend Laboratories,
LLC


180 Summit Avenue, Suite 200


Montvale, NJ 07645


Attention: S. Venkatesh, President


Facsimile: 201-476-1987


 


With a copy to:


Ascend Laboratories, LLC


180 Summit Avenue, Suite 200


Montvale, NJ 07645


Attention: William T. Moran III/Director – Supply
Chain


Facsimile: 201-476-1987


 


Any such notice provided pursuant to this
Section 10.3 shall be deemed to have been received by the addressee five business days following the date of dispatch of the notice
or other document by 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. 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 10.3.


 


165 Ludlow Avenue • Northvale, NJ 07647
• Ph: (201)750-2646 • Fax: (201)750-2755 www.elitepharma.com


{***} 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.


 




     


     


    

 


The new Exhibit A shall read as
follows:


 


Exhibit A - Product and Purchase
Price and Minimum Annual Volume Requirements


 


	Product	 	Mg	 	Firm Cost Per

1000 tablets

exclusive of API

FOB Elite	 	Minimum

Annual

Volume
	Methadone Hydrochloride 10 mg Tablets, bulk, ANDA #090635	 	10mg	 	
        Manufacturing Cost:

        ${***} per 1000 tablets guaranteed,

        Minimum Annual Volume of 50,000,000 tablets
        (see notes below)
	 	50,000,000 Tablets


 


NOTES: The purchase price is
FOB Elite’s facility and title and risk of loss pass to Ascend upon delivery to the carrier. The purchase price includes
all costs for bulk tablet manufacture except API cost which is the obligation of TPN and is firm during the term of the Agreement.


 


The new Exhibit B shall read as
follows:


 


EXHIBIT B


Product and Packaging Specifications


 


The written specifications for the Product shall be for Methadone
Hydrochloride Bulk Tablets, USP 10 mg pursuant to the terms of the ANDA # 090635


 





Section 4.7 of Appendix 2 of Exhibit C
(the Quality Agreement between the parties) shall read as follows:


 


Section 4.7 Packaging, Labeling and Finish
Product Release


 


TPN is responsible for packaging, labeling
and finished product release for the Product.


 


165 Ludlow Avenue • Northvale, NJ 07647
• Ph: (201)750-2646 • Fax: (201)750-2755 www.elitepharma.com


{***} 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.


 




     


     


    

 


Appendix 2 of Exhibit C (the Quality Agreement
between the parties) shall read as follows:


 


APPENDIX 2


 


PRODUCT LISTING


 


Methadone Hydrochloride Bulk Tablets, USP
10 mg pursuant to the terms of the ANDA # 090635


 


Except as expressly modified by this letter
agreement, the parties agree that the Agreement will continue in full force and effect in accordance with its terms.


 


If the foregoing correctly sets forth our
agreement and understanding, please execute the enclosed counterpart of this letter agreement and return the executed counterpart
to the undersigned at your convenience.


 


	ELITE PHARMACEUTICALS, INC.	 
	 	 	 
	By  	s/Nasrat Hakim	 
	 	 	 
	Name:	Nasrat Hakim	 
	Title:	President and CEO	 


 


Accepted and agreed as of this June 10,
2015


 


	ASCEND LABORATORIES, LLC	 
	 	 	 
	By  	S. Venkatesh	 
	 	 	 
	Name:	S. Venkatesh	 
	Title:	President	 


 


165 Ludlow Avenue • Northvale, NJ 07647
• Ph: (201)750-2646 • Fax: (201)750-2755 www.elitepharma.com


{***} 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.