UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 8-K

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(D)

OF THE SECURITIES EXCHANGE ACT OF 1934

 

May 29, 2018 (May 22, 2018)

Date of Report (Date of earliest event reported)

 

ELITE PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

 

Nevada  001-15697  22-3542636
(State or other jurisdiction  (Commission  (IRS Employer
of incorporation)  File Number)  Identification No.)

 

 

165 Ludlow Avenue, Northvale, New Jersey 07647

(Address of principal executive offices)

 

(201) 750-2646

(Registrant’s telephone number, including area code)

 

 
(Former name or former address, if changed since last report.)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company ¨

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

 


 

 


  

Item 1.01Entry Into A Material Definitive Agreement.

 

On May 22, 2018, Elite Pharmaceuticals Inc. (“Elite”) signed a License, Supply and Distribution Agreement with Glenmark Pharmaceuticals, Inc., USA (“Glenmark”) to market two Elite generic products in the United States with the option to add products in the future. Glenmark will have semi-exclusive marketing rights to the ANDA approved product, phendimetrazine 35 mg tablets and exclusive marketing rights to an undisclosed pain product, currently under review by the FDA with an expected approval date in the third quarter of this year. Elite will receive manufacturing and license fees from the product sales and the license fee will be computed as a percentage of the gross profit earned by Glenmark product sales. The term of the License Agreement is three years and may be extended upon mutual agreement for additional 1-year periods. Prices for the manufacture of the various products may be changed following December 31, 2018 for price changes and certain other regulatory requirements.

 

 

Item 9.01Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.Description
99.1Press Release dated May 29, 2018

 

 

 

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

Dated: May 29, 2018 ELITE PHARMACEUTICALS, INC.  
       
       
  By: /s/ Nasrat Hakim      
    Nasrat Hakim, President and CEO