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EXCEL - IDEA: XBRL DOCUMENT - ELITE PHARMACEUTICALS INC /NV/Financial_Report.xls
EX-32.1 - EXHIBIT 32.1 - ELITE PHARMACEUTICALS INC /NV/v400439_ex32-1.htm
EX-31.2 - EXHIBIT 31.2 - ELITE PHARMACEUTICALS INC /NV/v400439_ex31-2.htm
EX-31.1 - EXHIBIT 31.1 - ELITE PHARMACEUTICALS INC /NV/v400439_ex31-1.htm
EX-10.83 - EXHIBIT 10.83 - ELITE PHARMACEUTICALS INC /NV/v400439_ex10-83.htm
EX-10.84 - EXHIBIT 10.84 - ELITE PHARMACEUTICALS INC /NV/v400439_ex10-84.htm
10-Q - 10-Q - ELITE PHARMACEUTICALS INC /NV/v400439_10q.htm
EX-32.2 - EXHIBIT 32.2 - ELITE PHARMACEUTICALS INC /NV/v400439_ex32-2.htm

 

Exhibit 10.82

 

January 19, 2015

 

S.Venkatesh

President

Ascend Laboratories, LLC

180 Summit Avenue, Suite 200

Montvale, NJ 07645

 

Re:Second 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

 

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 (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 shall be deleted and Sections 1.4, 2.7, 3.2, 7.1, 7.3, 10.3, and Exhibit A attached to the Agreement are amended in their entirety and, as amended, read as follows:

 

Section 1.4 “ELITE” shall mean Elite Pharmaceuticals, Inc., a Nevada corporation, and Elite Laboratories, Inc., a Delaware corporation (a subsidiary of Elite Pharmaceuticals, Inc.).

 

Section 2.7            Delays. During the Term of this Manufacturing Agreement, if ELITE is not able to timely meet Product orders submitted by TPN pursuant to Section 2.2, ELITE shall promptly notify TPN of the reason for the delay and the date delivery of Product is expected to occur.

 

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 10.82

 

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, 2015; 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 7.3Consequences 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.

 

(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

 

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 10.82

 

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.

 

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

 

 

Product   Mg    Bottle
Size 
  Firm Cost Per
Bottle exclusive
of API FOB
Elite
  Minimum
Annual
Volume
Methadone Hydrochloride 10 mg Tablets, ANDA #090635   10mg    100's  

 

Manufacturing Cost ${***} (see notes below)

 

  {***} Bottles

 

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 10.82

 

NOTES: The purchase price includes all costs except API cost which is the obligation of TPN and is firm during the term of the Agreement.

 

ELITE may also, from time to time, subcontract to Epic Pharma, LLC for bottling of batches.

 

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 January 19, 2015  
   
ASCEND LABORATORIES, LLC  
   
By /s/ 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.