form8kpr111609.htm
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
DC 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) November 16, 2009
NOVADEL
PHARMA INC.
(Exact
Name of Registrant as Specified in Its Charter)
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Delaware
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001-32177
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22-2407152
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(State
or other jurisdiction
of
incorporation or organization)
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(Commission
File No.)
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(I.R.S.
Employer
Identification
No.)
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25
Minneakoning Road
Flemington,
New Jersey 08822
(Address
of principal executive offices) (Zip Code)
(908)
782-3431
(Registrant’s
telephone number, including area code)
N/A
(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 (see General
Instruction A.2. below):
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
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Item
1.01. Entry
into a Material Definitive Agreement.
On
November 16, 2009, NovaDel Pharma Inc. (“NovaDel”), a Delaware corporation,
issued a press release to announce that it had entered into an exclusive license
and distribution agreement (the “Agreement”) with ECR Pharmaceuticals Company,
Inc. (“ECR”) to commercialize and manufacture NovaDel’s ZolpiMist™ in the United
States and Canada. ZolpiMist™ is NovaDel’s oral spray formulation of zolpidem
tartrate, which was approved by the FDA in December of 2008. Under the terms of
the Agreement, ECR will pay NovaDel $3,000,000 upon the execution of the
Agreement and ongoing performance payments of up to 15% of net sales on branded
products and a lesser percent of net sales on authorized generic products,
subject to the terms of the Agreement. A performance milestone will be due to
NovaDel if net sales reach a certain level.
NovaDel
has an opportunity to co-promote zolpidem tartrate oral spray in the United
States and Canada with ECR’s consent, and retains commercialization rights for
all other territories. ECR will assume responsibility for manufacturing the
product for commercialization in the United States and Canada, including any
activities required from the date of the Agreement.
The
Agreement contains customary termination provisions. In addition, the Agreement
may be terminated by ECR for any reason upon written notice to NovaDel, which
will be effective 180 days from the date of receipt of such notice, provided
that ECR may not terminate until the second anniversary after the first
commercial sale of ZolpiMist™ by ECR or its affiliates.
The
foregoing is a summary of the material terms of the Agreement and does not
purport to be complete. You should read the complete Agreement which shall be
attached as an exhibit either to an amended Current Report on Form 8-K or
NovaDel’s Annual Report on Form 10-K for the period ended December 31,
2009.
Item
9.01. Financial
Statements and Exhibits.
(d)
Exhibits.
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99.1
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Press
release of NovaDel Pharma Inc. dated November 16, 2009, titled “NovaDel
Signs Exclusive License and Distribution Agreement with Hi-Tech Pharmacal
Co., Inc’s Subsidiary to Commercialize and Manufacture ZolpiMist™ in the
US and Canada.”
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SIGNATURES
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.
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NovaDel Pharma
Inc. |
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Date:
November 16, 2009
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By:
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/s/ Steven
B. Ratoff |
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Steven
B. Ratoff |
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Chairman,
Interim Chief Financial Officer, Interim President and Chief Executive
Officer |
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