UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K/A
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D)
OF THE SECURITIES EXCHANGE ACT OF 1934
March 30, 2005
---------------------------
Date of Report (Date of earliest event reported)
ELITE PHARMACEUTICALS, INC.
-----------------------------------------------
(Exact name of registrant as specified in its charter)
Delaware 333-45241 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))
This Amendment No. 4 to the Form 8K amends the Form 8K, dated March 30, 2005 and
filed with the Securities and Exchange Commission (the "Commission") on April 5,
2005 (the "Original Filing"), as amended by Amendment No. 1 to the Form 8K,
dated March 30, 2005 and filed with the Commission on May 10, 2005, as amended
by Amendment No. 2 to the Form 8K, dated March 30, 2005 and filed with the
Commission on June 13, 2005, as amended by Amendment No. 3 to the Form 8K, dated
March 30, 2005 and filed with the Commission on July 20, 2005 for the purpose of
further amending Exhibit 10.1. Except as indicated below and filed herewith, the
exhibits listed below were filed as exhibits to the Original Filing.
ITEM 1.01. ENTRY INTO MATERIAL DEFINITIVE AGREEMENT.
On March 30, 2005, Elite Laboratories, Inc., a Delaware corporation and
wholly owned subsidiary of Elite Pharmaceuticals, Inc., a Delaware corporation
(the "REGISTRANT") entered into a product development, manufacturing and
distribution agreement with Harris Pharmaceutical, Inc. ("Harris") and Tish
Technologies LLC ("Tish") for the development and marketing of a generic
controlled release drug. The agreement provides for (1) the development of the
drug by the Registrant with costs of development to be shared by the Registrant
and Harris, (2) the manufacture by the Registrant and its sale to Harris for
distribution and (3) Tish to be responsible for any requisite submissions to the
Food and Drug Administration relating to the product. The Registrant is to share
in the profits generated from the sale of the product.
The drug is an AB rated generic anti-infective product, which the Registrant
plans to develop in all dose strengths. The product is a generic equivalent to a
branded drug which has estimated addressable market revenues of approximately
$80 million per year.
ITEM 9.01. FINANCIAL STATEMENTS AND EXHIBITS
c) Exhibits
10.1 Product Development, Manufacturing and Distribution
Agreement, dated as of March 30, 2004*
99.1. Copy of Press Release, dated April 5, 2005
* The Registrant has requested confidential treatment with respect to the
referenced exhibit. In the event that the Commission should deny such request in
whole or in part, such exhibit or the relevant portions thereof shall be filed
by amendment to this Current Report on Form 8-K.
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: August 23, 2005
ELITE PHARMACEUTICALS, INC.
By: /s/ Bernard Berk
---------------------------
Name: Bernard Berk
Title: Chief Executive Officer