- Current report filing (8-K)
2009年2月18日 - 6:38AM
Edgar (US Regulatory)
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):
February 11, 2009
Acusphere, Inc.
(Exact Name of
Registrant as Specified in Its Charter)
Delaware
(State or Other
Jurisdiction of Incorporation)
000-50405
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04-3208947
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(Commission File
Number)
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(IRS Employer
Identification No.)
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500
Arsenal Street
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Watertown,
MA
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02472
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(Address of
Principal Executive Offices)
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(Zip Code)
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(617) 648-8800
(Registrants 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:
o
Written communications pursuant to Rule 425
under the Securities Act (17 CFR 230.425)
o
Soliciting material pursuant to Rule 14a-12
under the Exchange Act (17 CFR 240.14a-12)
o
Pre-commencement communications pursuant to Rule 14d-2(b) under
the Exchange Act (17 CFR 240.14d-2(b))
o
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,
2009, Acusphere, Inc. (the Company) entered into an amendment (the Third
GE Amendment) to the License Agreement by and between the Company and GE
Healthcare AS (GE) dated as of June 1, 2006, as previously filed with
the SEC with the Companys quarterly report on Form 10-Q for the quarter
ended June 30, 2006, and as amended on May 11, 2007, such amendment
as previously filed with the SEC with the Companys current report on Form 8-K
as filed on May 11, 2007, and as further amended on May 15, 2008,
such amendment as previously filed with the SEC with the Companys current
report on Form 8-K as filed on May 20, 2008 (the Second GE Amendment).
Under the Second GE
Amendment, the Company was due to make a series of payments due as follows:
$5.5 million due on June 1, 2007, payable in two installments commencing
on June 1, 2008, the first installment of $916,666.66 is due and payable
on June 1, 2008 and the remaining installment is due and payable on October 1,
2009 in an amount consisting of (i) the amount of $4,583,333.34 in
principal plus (ii) interest accruing on such principal amount from July 1,
2008 at the rate of 6% per annum until paid in full. Notwithstanding the foregoing payments, upon
receipt of regulatory approval by the U.S. Food and Drug Administration to market
AI-700 in the United States, or the approval of a Marketing Authorization
Application to market AI-700 in Europe, prior to September 1, 2010, any
then remaining balance of the $4,583,333.34 (plus interest accrued
to such date) payable as described above
would have been immediately due and payable in full. The Third GE Amendment provides that, in lieu
of these payments, the Company shall make a series of payments due as follows: (i) $250,000.00
due on February 11, 2009, (ii) $250,000.00 due upon the closing of an
equity or debt investment in the Company or credit facility made available to
the Company in an amount of at least $5 million, and (iii) $4,271,333.34
due on February 15, 2009 and payable with accrued interest at a rate of 6%
on December 31, 2013; provided, that, within sixty days after the first
commercial sale of AI-700 in the United States or Europe, prior to December 31,
2013, any then remaining balance of the $4,271,333.34 (plus interest accrued to
such date) shall be immediately due and payable in full. The terms of
the license agreement with GE are otherwise unchanged.
On February 12,
2009, the Company entered into a third amendment (the Third BSP Amendment) to
the Patent Transfer Agreement by and between the Company and Bayer Schering
Pharma AG (BSP) dated as of May 11, 2005, as previously filed with the
Securities and Exchange Commission (the SEC) with the Companys quarterly
report on Form 10-Q for the quarter ended March 31, 2005, and as
amended on April 27, 2007, such amendment as previously filed with the SEC
with the Companys current report on Form 8-K as filed on May 3,
2007, and as further amended on May 15, 2008, such amendment as previously
filed with the SEC with the Companys current report on Form 8-K as filed
on May 20, 2008 (the Second BSP Amendment). Under the Second BSP
Amendment, the Company was due to make a series of payments due as follows:
$200,000 on or before fifteen days following execution of the Second BSP
Amendment
and $1.8
million on or before fifteen days after May 11, 2009. The Third BSP
Amendment provides that, in lieu of the $1.8 million payment due on or before
fifteen days after May 11, 2009, the Company shall instead pay BSP a total
of $1.8 million as follows: (i) $100,000 on or before fifteen days after
the execution of the Third BSP Amendment; (ii) $100,000 on or before
fifteen days after the earlier of (a) the closing by Acusphere of an
equity
2
financing
in excess of $10 million or (b) May 11, 2013; and (iii) $1.6
million on or before fifteen days after May 11, 2013.
The terms of
the patent transfer agreement with BSP are otherwise unchanged.
Item 8.01 Other Events.
On
February 17, 2009, the Company issued a press release announcing
(i) that
it
has submitted an amendment to
its New Drug Application (NDA) for Imagify
TM
(Perflubutane Polymer
Microspheres) for Injectable Suspension to the U.S. Food & Drug
Administration and (ii) that it
had completed the renegotiation of payment terms under certain intellectual
property agreements. A copy of the press release is attached
hereto as Exhibit 99.1 and is incorporated by reference.
Item 9.01 Financial Statements and
Exhibits.
(d)
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Exhibits.
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Exhibit
No.
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Description
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10.1
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Third
Amendment to License Agreement by and between the Company and GE Healthcare
AS, dated as of February 11, 2009
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10.2
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Third
Amendment to Patent Transfer Agreement by and between the Company and Bayer
Schering Pharma AG, dated as of February 12, 2009
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99.1
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Press Release dated
February 17, 2009, filed herewith
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3
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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ACUSPHERE, INC.
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Dated:
February 17, 2009
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By:
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/s/ Lawrence A. Gyenes
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Name:
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Lawrence A. Gyenes
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Title:
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Senior Vice President,
Chief Financial
Officer and Secretary
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4
EXHIBIT INDEX
Exhibit
No.
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Description
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10.1
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Third
Amendment to License Agreement by and between the Company and GE Healthcare
AS, dated as of February 11, 2009
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10.2
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Third
Amendment to Patent Transfer Agreement by and between the Company and Bayer
Schering Pharma AG, dated as of February 12, 2009
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99.1
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Press Release dated
February 17, 2009, filed herewith
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5
Acusphere (CE) (USOTC:ACUS)
過去 株価チャート
から 12 2024 まで 1 2025
Acusphere (CE) (USOTC:ACUS)
過去 株価チャート
から 1 2024 まで 1 2025