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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
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FORM
8-K
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CURRENT
REPORT
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Pursuant
to Section 13 OR 15(d) of the Securities Exchange Act of
1934
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Date
of Report (Date of earliest event reported): December 22,
2010
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Apricus
Biosciences, Inc.
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(Exact
name of registrant as specified in its
charter)
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Nevada
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0-22245
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87-0449967
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(State
or other jurisdiction of incorporation)
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(Commission
File Number)
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(I.R.S.
Employer Identification No.)
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6330
Nancy Ridge Drive, Suite 103, San Diego, California
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92121
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(Address
of principal executive offices)
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(Zip
Code)
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Registrant’s
telephone number, including area code (858)
222-8041
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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:
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¨
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
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¨
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
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¨
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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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¨
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13a-4(c))
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Item
1.01 Entry
into Material Definitive Agreement
On
December 22, 2010, NexMed (U.S.A.), Inc. and NexMed Holdings, Inc. (together,
“NexMed”), wholly owned subsidiaries of Apricus Biosciences, Inc. (“Apricus”
and, together with NexMed, the “Company”), entered into a license agreement (the
“License Agreement”) with BRACCO SpA (“Bracco”), granting Bracco the exclusive
rights in Italy (the “Territory”) to commercialize Vitaros®, the Company’s
erectile dysfunction treatment.
Vitaros
is approved for commercialization in Canada and the Company expects to file for
approval in Europe in April 2011. Under the License Agreement, the
Company is responsible for pursuing regulatory approval of Vitaros in the
Territory. Upon obtaining regulatory approval, Bracco will be
required to commercially launch Vitaros within three months and thereafter to
undertake certain efforts to successfully commercialize the
product.
Under the
License Agreement, the Company is entitled to receive upfront license fees and
milestone payments of up to €5.5 million. The milestones are tied to
timely filing for regulatory approval, receipt of regulatory approval for
Vitaros in the Territory and the achievement of certain levels of aggregate net
sales of Vitaros. Additionally, the Company is entitled to receive
escalating tiered double-digit royalties on Bracco’s sales of Vitaros in the
Territory. Bracco may also elect to continue to sell Vitaros after
the expiration of the patents covered by the License Agreement, in which case
Bracco would thereafter pay royalties at a reduced rate.
Bracco
may terminate the License Agreement under certain circumstances if the Company
does not timely meet predetermined milestones for obtaining regulatory approval
of Vitaros in the Territory, or if certain competing products are introduced
prior to or shortly after regulatory approval is obtained. If Bracco
terminates for these reasons, it will be entitled to a termination payment from
the Company, which will be payable in a combination of Apricus common stock and
either cash or a credit to be applied to a license by Bracco of other Company
products or product candidates. If Bracco terminates the License
Agreement for convenience, it will be required to make a termination payment to
the Company.
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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Apricus
Biosciences, Inc.
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By:
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/s/
Mark Westgate
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Name:
Mark Westgate
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Title:
Vice President and Chief Financial Officer
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Date:
December 29, 2010