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
January
4, 2011
Date of
Report (Date of earliest event reported)
ELITE
PHARMACEUTICALS, INC.
(Exact
name of registrant as specified in its charter)
|
Delaware
|
|
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))
Item
1.01 Entry Into A Material Definitive Agreement.
On
January 4, 2011, Elite Pharmaceuticals Inc. (“Elite”) executed a Development and
Supply Agreement (“Agreement”) with Hi-Tech Pharmacal Co., Inc. (“Hi-Tech”) for
Elite to develop an intermediate for Hi-Tech for a generic version of a
prescription pharmaceutical product.
Pursuant
to the Agreement, Hi-Tech has engaged Elite to develop and manufacture an
intermediate product (“Intermediate Product”) for use in a prescription
pharmaceutical product (the “Product”). Elite agrees to manufacture
the Intermediate Product pursuant to a separate manufacturing agreement and
quality assurance agreement to be executed by Elite and
Hi-Tech. Hi-Tech, or its designees, shall prepare all applications
necessary to obtain any product registrations required to market the
Product. All Registrations shall be solely owned by Hi-Tech including
any Abbreviated New Drug Application filed with the U.S. Food and Drug
Administration (“ANDA”) for the Product. Elite shall provide Hi-Tech
with all pharmaceutical, technical, and clinical data and information in support
of the ANDA application by Hi-Tech for the approval of the
Product. In consideration of Elite’s performance in accordance with
the terms and conditions of the Agreement, Hi-Tech shall pay Elite’s fees for
the Development Program and shall pay Elite a percentage of the Net Profit
earned from the Product.
Hi-Tech
shall own and market the Product under its own Trademark. During the
term of this Agreement and for a period of five (5) years following the
termination of this Agreement, neither Party shall produce, develop or market,
any product competitive with the Product without the prior written approval of
the other Party. The term of this Agreement shall be effective from
the date consummated and shall continue for a ten (10) year term after the
initial marketing of the Product. Upon the expiration of the initial term or any
renewal term, this Agreement will automatically renew for an additional five (5)
year term, unless one Party gives at least six (6) months notice in writing in
advance of its intent not to renew.
* The
Registrant has requested confidential treatment with respect to this 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.
Item 9.01.
Financial Statements and Exhibits.
a) Not
applicable.
b) Not
applicable.
c)
Exhibits
10.1 Product
Development Agreement between the Company and Hi-Tech Pharmacal Co., Inc., dated
as of December XX, 2010*
99.1 Copy
of Press Release, dated January 10, 2011
* The
Registrant has requested confidential treatment with respect to this 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: January
10, 2010
|
ELITE
PHARMACEUTICALS, INC.
|
|
|
|
|
By:
|
/s/ Chris
Dick
|
|
|
Name: Chris
Dick
|
|
Title:
|
President
& Chief Operating
Officer
|