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
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))
ITEM 1.01. ENTRY INTO MATERIAL DEFINITIVE AGREEMENT.
On March 30, 2005, Elite Pharmaceuticals, Inc's., a Delaware corporation
(the "REGISTRANT") wholly owned subsidiary entered into an agreement with a
privately held specialty dermatological marketing company and a privately held
boutique formulation development company for the development and marketing of a
generic controlled release drug delivery system in an undisclosed area. The
agreement provides for the development and manufacture of the drug by the
Registrant and its sale to the marketing company for distribution, and the
formulation development company to be responsible for the requisite submissions,
if any to the FDA. The Registrant is to share in profits, if any from sales of
the drug. Prior to obtaining an ANDA, the agreement may be terminated by the
marketing company at any time upon 30 days notice.
The drug is a generic equivalent to a branded drug, which the Registrant
believes has 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 Securities and Exchange 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: April 5, 2005
ELITE PHARMACEUTICALS, INC.
By: /s/ BERNARD BERK
---------------------------
Name: Bernard Berk
Title: Chief Executive Officer