corresp
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Writers direct phone
(312) 460-5962
Writers e-mail
mblount@seyfarth.com
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131 South Dearborn Street
Suite 2400
Chicago, Illinois 60603
(312) 460-5000
fax (312) 460-7000
www.seyfarth.com |
March 14, 2008
VIA EDGAR
Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Attn: Jeffrey P. Riedler
Assistant Director
Division of Corporation Finance
Re: Aastrom Biosciences, Inc.
Form 10-K for the Year Ended June 30, 2007
File No. 000-22025
Dear Mr. Riedler:
Aastrom Biosciences, Inc. (the Company) has filed with the Commission an amended Form 10-K
on Form 10-K/A for the year ended June 30, 2007 (the Form 10-K/A). The changes reflected in the
Form 10-K/A are intended to respond to the comments set forth in your letter dated March 3, 2008
(the Comment Letter). Specifically, the Form 10-K/A files as an exhibit the Dominos Farms
Office Park Lease, which was inadvertently omitted as an exhibit in the Form 10-K filed with the
Commission on September 13, 2007. As explained below, the Company does not believe that the other
agreements referred to in the Comment Letter are material agreements and, therefore, they not need
to be filed as exhibits in the Form 10-K/A.
Item 15, page 55
1(a). Musculoskeletal Transplant Foundation. The agreement with the Musculoskeletal
Transplant Foundation (MTF) was entered into in June 2003, and provided for collaboration between
the parties up to and including clinical trials, as well as a material transfer agreement whereby
the Company receives free cadaver-based demineralized bone matrix material (DBMM) for use in the
Companys U.S. orthopedic clinical trials. The material transfer agreement is the only portion of
the collaboration that has been implemented by the parties. The agreement does not require either
party to enter into these collaborations nor does it provide for any penalties if they do not do
so. There are other commercially available DBMM products as well as synthetic products that could
be substituted for the MTF DBMM. So, the Company is not now, nor is it likely in the
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ATLANTA
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BOSTON
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CHICAGO
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HOUSTON
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LOS ANGELES
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NEW YORK
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SACRAMENTO
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SAN FRANCISCO
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WASHINGTON, D.C.
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BRUSSELS |
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Securities and Exchange Commission
Attn: Jeffrey P. Riedler
March 14, 2008
Page 2 |
future to be,
dependent on the supply of MTF DBMM. The Company estimates that the total value of the free DBMM
received from MTF since the inception of the agreement to be less than $75,000. The Company
believes that the relationship with MTF is part of its day-to-day normal operations and that it is
not substantially dependent on its relationship with MTF, and, therefore, the agreement would not
be a material agreement within the meaning of Item 601(b)(10)(ii)(B) of Regulation S-K.
1(b). Orthovita. The Company entered into an agreement with Orthovita in March 2006. This
agreement operates as a material transfer agreement and is similar to the MTF agreement except that
Orthovita supplies free synthetic ceramic matrix material (SCMM) that functions similarly to the
DBMM supplied by MTF. The Company and prescribing physicians could substitute commercially
available SCMM or DBMM if the Orthovita SCMM were not available at commercialization. The Company
estimates that the retail value of the SCMM received from Orthovita since inception of the
agreement to be approximately $50,000. The Company believes that the relationship with Orthovita
is part of its day-to-day normal operations and that it is not substantially dependent on its
relationship with Orthovita, and, therefore, the agreement would not be a material agreement within
the meaning of Item 601(b)(10)(ii)(B) of Regulation S-K.
1(c). Fraunhofer. In February 2005, the Company entered into a manufacturing arrangement
with Fraunhofer in Germany. The agreement provides certain manufacturing services to the Company
for clinical trial and other small-scale production in Germany at the Companys direction. The
agreement had an initial term of one year from validation and is being extended on a month-to-month
basis. The initial agreement called for payments of approximately 74,000 Euros for facility
validation work. There are monthly minimum payments for facilities and personnel of approximately
5,450 Euros. Including validation work, minimum monthly payments and production costs, the Company
has paid Fraunhofer approximately $581,000 over the three years the agreement has been in place, or
approximately $194,000 annually. The Company has several other sites that are capable of and
licensed to manufacture product in Germany and Spain which provide redundancy for Fraunhofer. The
Company believes that the relationship with Fraunhofer is
part of its day-to-day normal operations and that it is not substantially dependent on its
relationship with Fraunhofer, and, therefore, the agreement would not be a material agreement
within the meaning of Item 601(b)(10)(ii)(B) of Regulation S-K.
2. Dominos Farm Office Lease. As mentioned above, the Company inadvertently omitted the
Dominos Farm Office Lease from the exhibits in the Companys Form 10-K for the year ended June 30,
2007. This agreement has been filed as part of the Form 10-K/A.
The Company acknowledges that:
(a) the Company is responsible for the adequacy of the disclosure in the filings;
(b) staff comments or changes to disclosure in response to staff comments do not foreclose
the Commission from taking any action with respect to the filings; and
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Securities and Exchange Commission
Attn: Jeffrey P. Riedler
March 14, 2008
Page 3 |
(c) the Company may not assert staff comments as a defense in any proceeding initiated by the
Commission or any person under the federal securities laws of the United States.
The Company appreciates the staffs comments with respect to its Form 10-K for the year ended
June 30, 2007. If you have any questions with respect to this letter, please contact the
undersigned at (312) 460-5962.
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Very truly yours,
SEYFARTH SHAW LLP
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/s/ Michael Blount
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Michael E. Blount |
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cc: |
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Sonia Barros
George W. Dunbar, Jr. |