Attached files
| file | filename |
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| EX-99.1 - EX-99.1 - ELITE PHARMACEUTICALS INC /NV/ | v196863_ex99-1.htm |
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
September
10, 2010
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
September 10, 2010, Elite Pharmaceuticals Inc. (“Elite”) executed a License
Agreement with Precision Dose, Inc. (“Precision Dose”), which is entitled to
exercise the rights and benefits of the License Agreement through its
wholly-owned subsidiary, TAGI Pharma, Inc., to market and sell four Elite
generic products in the United States, Puerto Rico and
Canada. Precision Dose will have the exclusive right to market the
products in the United States and Puerto Rico and a non-exclusive right to
market the products in Canada. Pursuant to the License Agreement,
Elite will receive a license fee and milestone payments. The license
fee will be computed as a percentage of the gross profit, as defined in the
License Agreement, earned by Precision Dose as a result of sales of the
products. The license fee is payable monthly for the term of the
License Agreement. The milestone payments will be paid in 6
installments. The first installment was paid upon execution of the
License Agreement. The remaining installments are to be paid upon FDA
approval and initial shipment of the products to Precision Dose. The
term of the License Agreement is 15 years and may be extended for 3 successive
terms, each of 5 years. Twelve months following the launch of a
product covered by the License Agreement, Elite may terminate the exclusive
marketing rights if the license fee paid by Precision Dose falls below a
designated amount. Elite may also terminate the exclusive marketing
rights if Precision Dose is unable to meet the annual unit volume forecast for a
designated Product group for any year, subject to the ability of Precision Dose,
during the succeeding 6 month period, to achieve at least one-half of the prior
year’s minimum annual unit volume forecast. The License Agreement may
be terminated by mutual agreement of Elite and Precision Dose, as a result of a
breach by either party that is not cured within 60 days notice of the breach or
by Elite as a result of Precision Dose becoming a party to a bankruptcy,
reorganization or other insolvency proceeding that continues for a period of 30
days or more.
Elite
will manufacture the products on an exclusive basis for Precision Dose or TAGI
Pharma, Inc. pursuant to a Manufacturing and Supply Agreement (the
“Manufacturing Agreement”), also dated September 10, 2010. The term
of the Manufacturing Agreement is co-extensive with the term of the License
Agreement. Prices for the manufacture of the various products may be
increased following the later of the first anniversary of the first shipment of
a product or the first anniversary of the previous price increase related to the
product. Prices for the manufacture of the products may also be
decreased in the event of reductions in material or component
costs. In the event that Elite cannot supply one or more of the
products at a price that is low enough to allow Precision Dose or TAGI Pharma,
Inc. to sell the product profitably, then Elite may provide the product through
a third party supplier. Pursuant to the Manufacturing Agreement, each
party has indemnified the other against damages resulting from, among other
things, a failure of the party’s obligations under the Manufacturing Agreement
or a breach of the party’s representations or warranties.
Item
2.01 Completion of Acquisition or Disposition of Assets.
On
September 10, 2010, Elite, together with its subsidiary, Elite Laboratories,
Inc., executed a Purchase Agreement with Epic Pharma LLC (the “Seller”) for the
purpose of acquiring from the Seller Abbreviated New Drug Application (“ANDA”)
number 20-272 for a generic product. The ANDA has been filed with the FDA and
seeks authorization and approval to manufacture, package, ship and sell the
product. The acquisition of the ANDA will close on the later of 60
days from the date of the Purchase Agreement or upon receipt of FDA approval of
the ANDA. Upon the closing, Elite will pay a portion of the purchase
price. The remainder of the purchase price will be paid in quarterly
installments over a period of three years, beginning at the end of the first
full quarter following the closing. Elite has agreed to pay expenses
relating to the acquisition, including sales taxes, use taxes, transfer taxes
and similar taxes (but not including taxes on income or gains earned by the
Seller), fees and expenses incurred as a result of the
transfer. Until all of the purchase price is paid, Elite may not
convey, sell, assign, transfer, license or otherwise dispose of the assets
acquired without the consent of the Seller, which may not be withheld
unreasonably. The Purchase Agreement also includes mutual
indemnification provisions pursuant to which the Seller indemnifies Elite for
liabilities relating to the assets acquired which arise as a result of actions
taken prior to the closing and Elite indemnifies the Seller for liabilities
relating to the assets acquired which arise as a result of actions taken after
the closing. The right to market this product was licensed to
Precision Dose on September 10, 2010. (See Item
1.01.)
Item
9.01. Financial Statements and Exhibits.
(c)
Exhibits
99.1
Press Release dated September 16, 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 16, 2010
| ELITE PHARMACEUTICALS, INC. | |||
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By:
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/s/ Chris Dick
|
||
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Name:
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Chris
Dick
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||
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Title:
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President
& Chief Operating
Officer
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