Attached files
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| EX-99.1 - AEOLUS PHARMACEUTICALS, INC. | v211668_ex99-1.htm |
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
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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): February 11, 2011
AEOLUS PHARMACEUTICALS,
INC.
(Exact
name of registrant as specified in its charter)
Delaware
(State or
other jurisdiction of incorporation)
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0-50481
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56-1953785
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(Commission File Number)
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(IRS Employer Identification No.)
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26361
Crown Valley Parkway, Suite 150
Mission
Viejo, California 92691
(Address
of Principal Executive Offices, Including Zip Code)
949-481-9825
(Registrant’s
Telephone Number, Including Area Code)
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):
¨ 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
February 11, 2011, Aeolus Pharmaceuticals, Inc. (the “Company”) entered into a
cost plus, fixed fee development agreement with the Office of the Biomedical
Advanced Research and Development Authority (“BARDA”), part of the National
Institutes of Health, for the advanced development of AEOL 10150 as a medical
countermeasure against the pulmonary sub-syndrome of acute radiation syndrome
(the “Contract”).
Pursuant
to the Contract, the Company will receive approximately $10.5 million in the
first year base period of performance and up to an additional approximately
$107.5 million in four option years, if the options are exercised by BARDA, for
a total contract value of approximately $118 million. The first year base period
of performance is from February 11, 2011 to February 10, 2012. Each additional
one year option period, if exercised by BARDA following the Company’s completion
of specific tasks set forth in the Contract, would extend the period of
performance by an additional year. If all four options are exercised, the period
of performance would continue through February 10, 2016.
Activities
to be conducted during the first year base period of performance include dosing
studies, stability demonstrations, validation testing, compliance studies and
the filing of an investigational new drug (IND) application, an orphan drug
status application and a fast track designation application with the U.S. Food
and Drug Administration (the “FDA”). In the event BARDA exercises one
or more of the options to extend the term of the Contract, optional activities
to be conducted would include, among other things, additional stability
demonstrations, animal pivotal efficacy studies, human clinical safety studies
and Phase I, Phase II and pre-new drug application (NDA) meetings and
applications with the FDA.
Item
8.01. Other Events.
On
February 15, 2011, the Company issued a press release announcing the Contract,
which is attached as Exhibit 99.1 to this Current Report on Form 8-K and
incorporated herein by reference. Exhibit 99.1 shall not be deemed “filed” for
purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or
otherwise subject to the liabilities of that section, nor shall such information
be deemed incorporated by reference in any filing under the Securities Act of
1933, as amended, except as shall be expressly set forth by specific reference
in such a filing.
Item
9.01. Financial Statements and Exhibits.
(d) Exhibits
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Exhibit #
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Description
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99.1
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Press
Release dated February 15,
2011.
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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.
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Date: February
15, 2011
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AEOLUS
PHARMACEUTICALS, INC.
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/s/
John
L. McManus
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John
L. McManus
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President
and Chief Executive
Officer
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