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
Date of
Report (Date of earliest event reported)
ELITE
PHARMACEUTICALS, INC.
(Exact
name of registrant as specified in its charter)
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Delaware
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001-15697
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22-3542636
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(State
or other jurisdiction
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(Commission
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(IRS
Employer
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of
incorporation)
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File
Number)
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Identification
No.)
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165
Ludlow Avenue, Northvale, New Jersey 07647
(Address
of principal executive offices)
(Registrant’s telephone number,
including area code)
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(Former
name or former address, if changed since last
report.)
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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 August
27, 2010, Elite Pharmaceuticals Inc. (“Elite”) executed an agreement with Mikah
Pharma, LLC (“Mikah”) to undertake and perform development work to facilitate
the preparation of a regulatory filing for a product under development (the
“Product Development Agreement”). The product will be formulated with
a previously approved drug substance and will be designed to be delivered in a
unique delivery profile. Among other responsibilities, Elite will
provide formulation, analytical development, clinical batch manufacture and
validation work for the product. The parties agreed that, in lieu of
cash, the transfer to Elite of the Naltrexone product in accordance with the
terms of the Naltrexone Asset Purchase Agreement (see discussion at Item 2.01
below), which they valued at $200,000, constituted the consideration for the
development services being performed by Elite under the Product Development
Agreement. Mikah will also pay to Elite, on a quarterly basis, a
royalty in the amount of 5% of net sales of the product. The royalty
will be due and payable for the duration of the period beginning on the date
that the product is approved by the United States Food and Drug Administration
(the “FDA”) and ending on the date of the introduction into the market of an
equivalent generic product. Upon approval of the new drug application
by the FDA, Elite will manufacture the product and the parties will negotiate in
good faith a manufacturing and supply agreement for the product. The Product
Development Agreement has a term of 10 years. One year prior to the
termination date, the parties will meet to discuss the commercial options
relating to the supply and distribution of the product after the termination
date. There is no guarantee that the product will receive approval
from the FDA.
Item
2.01 Completion of Acquisition or Disposition of Assets.
On August
27, 2010, Elite executed the Naltrexone Asset Purchase Agreement with Mikah
pursuant to which Elite acquired from Mikah the Abbreviated New Drug Application
number 75-274 (Naltrexone Hydrochloride Tablets USP, 50 mg), and all amendments
thereto (the “ANDA”), that have to date been filed with the FDA seeking
authorization and approval to manufacture, package, ship and sell the products
described in the ANDA within the United States and its territories (including
Puerto Rico) for aggregate consideration of $200,000. In lieu of
cash, Mikah agreed to accept from Elite product development services to be
performed by Elite, as described in Item 1.02 above. Elite has
assumed and agreed to discharge certain liabilities related to the purchased
assets, including but not limited to liabilities arising from any infringement
claim, product liability claim or liabilities arising from an action by the FDA
or any other governmental entity, so long as any such liability occurs after the
date of acquisition. Elite granted to Mikah and its affiliates a
fully-paid, perpetual, royalty-free non-exclusive license to use the ANDA in
connection with the manufacture, registration or sale of the products outside of
the United States and its territories.
Item
9.01. Financial Statements and Exhibits.
(c)
Exhibits
99.1
Press Release dated September 1, 2010.
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:
September 1, 2010
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ELITE
PHARMACEUTICALS, INC. |
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By:
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/s/ Chris Dick
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Name: Chris
Dick
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Title:
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President
& Chief Operating
Officer
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