Document:

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.Exhibit

Exhibit 10.2

Galena Biopharma, Inc.
2000 Crow Canyon Place Suite 380 
San Ramon, California 94583

August 8, 2016

Lincoln Park Capital Fund, LLC
440 North Wells, Suite 410
Chicago, Illinois 60654

Dear Ladies & Gentleman:

Reference is made to that certain Purchase Agreement, dated as of November 18, 2014 (the “Purchase Agreement”), by and between GALENA BIOPHARMA, INC., a Delaware corporation (the “Company”), and LINCOLN PARK CAPITAL FUND, LLC, an Illinois limited liability company (the “Investor”).  Capitalized terms used but not otherwise defined shall have the meanings set forth in the Purchase Agreement.

The Company and the Investor agree that effective as of the date hereof, the Purchase Agreement is amended as follows:

		
	1.
	The second sentence of Section 2(a) “Commencement of Regular Sales of Common Stock” of the Purchase Agreement is amended and replaced in its entirety with the following:

“Beginning one (1) Business Day following the Commencement Date, the Company shall have the right, but not the obligation, to direct the Investor, by its delivery to the Investor of a Regular Purchase Notice from time to time, to purchase up to Five Hundred Thousand  (500,000) Purchase Shares (each such purchase a “Regular Purchase”), at the Purchase Price on the Purchase Date, provided, however, that (i) the Regular Purchase may be increased to up to Seven Hundred Fifty Thousand (750,000) Purchase Shares, provided that the Closing Sale Price of the Common Stock is not below $0.40 on the Purchase Date, and (ii) the Regular Purchase may be increased to up to One Million (1,000,000) Purchase Shares, provided that the Closing Sale Price of the Common Stock is not below $0.75 on the Purchase Date (all of which share amounts shall be appropriately adjusted for any reorganization, recapitalization, non-cash dividend, stock split or other similar transaction); provided,  however, that the Investor’s committed obligation under any single Regular Purchase shall not exceed Two Million Dollars ($2,000,000) (which amount shall be appropriately adjusted for any reorganization, recapitalization, non-cash dividend, stock split or other similar transaction), unless the parties mutually agree to increase the dollar amount of any Regular Purchase on any Purchase Date at the applicable Purchase Price.

Exhibit 10.2

		
	2.
	The second sentence of Section 2(b) “Accelerated Purchases” of the Purchase Agreement is amended and replaced in its entirety with the following:

“The Company may deliver an Accelerated Purchase Notice to the Investor only on a Purchase Date on which the Closing Sale Price is not below $0.50 (to be appropriately adjusted for any reorganization, recapitalization, non-cash dividend, stock split or other similar transaction).”

		
	3.
	Section 2(d) “Purchase Price Floor” is deleted in its entirety.

		
	4.
	The first sentence of Section 2(f) “Beneficial Ownership Limitation” of the Purchase Agreement is amended and replaced in its entirety with the following:

“Notwithstanding anything to the contrary contained in this Agreement, the Company shall not issue or sell, and the Investor shall not purchase or acquire, any shares of Common Stock under this Agreement which, when aggregated with all other shares of Common Stock then beneficially owned by the Investor and its affiliates (as calculated pursuant to Section 13(d) of the Exchange Act and Rule 13d-3 promulgated thereunder) would result in the beneficial ownership by the Investor and its affiliates of more than 4.99% of the then issued and outstanding shares of Common Stock (the “Beneficial Ownership Limitation”).

		
	5.
	The last sentence of Section 10 “Events of Default” of the Purchase Agreement is amended and replaced in its entirety with the following:

“In addition to any other rights and remedies under applicable law and this Agreement, so long as an Event of Default has occurred and is continuing, or if any event which, after notice and/or lapse of time, would become an Event of Default, has occurred and is continuing, the Company shall not deliver to the Investor any Regular Purchase Notice or Accelerated Purchase Notice, and the Investor shall not purchase any shares of Common Stock under this Agreement.”

Except as expressly set forth above, all other terms and conditions of the Purchase Agreement shall remain in full force and effect, without amendment thereto.

This amendment may be executed in counterparts, all of which taken together shall constitute one and the same original and binding instrument and shall become effective when all counterparts have been signed by each party and delivered to the other parties hereto, it being understood that all parties hereto need not sign the same counterpart.

                        

Exhibit 10.2

Very truly yours,

GALENA BIOPHARMA, INC.

By: _/s/ Mark W. Schwartz      
Name: Mark W. Schwartz
Title: President and CEO

Acknowledged and agreed:

LINCOLN PARK CAPITAL FUND, LLC
By: LINCOLN PARK CAPITAL, LLC
By: ROCKLEDGE CAPITAL CORPORATION

By: /s/ Josh Scheinfeld        
Name:     Josh Scheinfeld
Title: President

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