sv3za
As
filed with the Securities and Exchange Commission on February 19, 2009.
Registration
No. 333-155739
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Amendment No. 1 to
FORM S-3
REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933
AASTROM BIOSCIENCES, INC.
(Exact name of registrant as specified in its charter)
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Michigan
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94-3096597 |
(State or other jurisdiction of
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(I.R.S. Employer Identification |
incorporation or organization)
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Number) |
24 Frank Lloyd Wright Drive
P.O. Box 376
Ann Arbor, Michigan 48106
(734) 930-5555
(Address, including zip code, and telephone number, including area code, of registrants principal executive offices)
George W. Dunbar, Jr.
President and Chief Executive Officer
Aastrom Biosciences, Inc.
P.O. Box 376
Ann Arbor, Michigan 48106
(734) 930-5555
(Name, address, including zip code, and telephone number, including area code, of agent for service)
With a copy to:
Allan J. Reich
Seyfarth Shaw
131 South Dearborn Street
Suite 2400
Chicago, Illinois 60603
Telephone: (312) 460-5650
Facsimile: (312) 460-7650
Approximate date of commencement of proposed sale to the public: From time to time after this
Registration Statement becomes effective.
If the only securities being registered on this form are being offered pursuant to dividend or
interest reinvestment plans, please check the following box. o
If any of the securities being registered on this Form are to be offered on a delayed or continuous
basis pursuant to Rule 415 under the Securities Act of 1933, other than securities offered only in
connection with dividend or interest reinvestment plans, check the following box: þ
If this form is filed to register additional securities for an offering pursuant to Rule 462(b)
under the Securities Act, please check the following box and list the Securities Act registration
statement number of the earlier effective registration statement for the same offering. o
If this form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act,
check the following box and list the Securities Act registration statement number of the earlier
effective registration statement for the same offering. o
If this Form is a registration statement pursuant to General Instruction I.D. or a post-effective
amendment thereto that shall become effective upon filing with the Commission pursuant to Rule
462(e) under the Securities Act, check the following box. o
If this Form is a post-effective amendment to a registration statement filed pursuant to General
Instruction I.D. filed to register additional securities or additional classes of securities
pursuant to Rule 413(b) under the Securities Act, check the following box. o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated
filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
(Check one):
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Large accelerated filer
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Non-accelerated filer o
(Do not check if a smaller reporting company) |
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Smaller reporting company
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Pursuant to Rule 415(a)(6) under the Securities Act of 1933, as amended, the securities
registered pursuant to this Registration Statement include unsold securities previously registered
on the registrants Registration Statement on Form S-3 (File No. 333-123570) initially filed by the
registrant on October 11, 2005 (the Prior Registration Statement). The Prior Registration
Statement registered securities for a maximum offering price of
$50,000,000, of which $35,990,000
securities were sold under the Prior Registration Statement, leaving a balance of unsold securities
with an aggregate offering price of $14,010,000. In connection with the registration of such unsold
securities on the Prior Registration Statement, the Registrant paid filing fees of $5,885, which
filing fees will continue to be applied to such unsold securities included in this Registration
Statement. Pursuant to Rule 415(a)(6), the offering of unsold securities under the Prior
Registration Statement will be deemed terminated as of the date of effectiveness of this
Registration Statement.
THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR DATES AS MAY BE
NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT HAS FILED A FURTHER AMENDMENT THAT
SPECIFICALLY STATES THAT THIS REGISTRATION STATEMENT SHALL THEREAFTER BECOME EFFECTIVE IN
ACCORDANCE WITH SECTION 8(A) OF THE SECURITIES ACT OF 1933 OR UNTIL THE REGISTRATION STATEMENT
SHALL BECOME EFFECTIVE ON SUCH DATE AS THE COMMISSION ACTING PURSUANT TO SAID SECTION 8(A), MAY
DETERMINE.
The information in this prospectus is not complete and may be changed. We may not sell these
securities until the registration statement filed with the Securities and Exchange Commission is
effective. This prospectus is not an offer to sell these securities and we are not soliciting
offers to buy these securities in any state where the offer or sale is not permitted.
SUBJECT
TO COMPLETION, DATED FEBRUARY 19, 2009.
PROSPECTUS
$50,000,000
AASTROM BIOSCIENCES, INC.
Common Stock
Preferred Stock
Debt Securities
Warrants
We may from time to time issue, in one or more series or classes, up to $50,000,000 in
aggregate principal amount of our common stock, preferred stock, debt securities and/or warrants.
We may offer these securities separately or together. We will specify in the accompanying
prospectus supplement the terms of the securities being offered. We may sell these securities to or
through underwriters and also to other purchasers or through agents. We will set forth the names of
any underwriters or agents, and any fees, conversions, or discount arrangements, in the
accompanying prospectus supplement. We may not sell any securities under this prospectus without
delivery of the applicable prospectus supplement.
You should read this document and any prospectus supplement or amendment carefully before you
invest.
Our
common stock is traded on the Nasdaq Capital Market under the symbol
ASTM. On February 11, 2009, the last reported sale price for our common
stock was $ 0.52 per share.
Investing in the common stock involves certain risks. See Risk Factors beginning on page 3
for a discussion of these risks.
Neither the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or determined if this prospectus is truthful or
complete. Any representation to the contrary is a criminal offense.
The date
of this Prospectus is February 19, 2009.
TABLE OF CONTENTS
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EX-5 |
EX-23 |
You may rely only on the information provided or incorporated by reference in this Prospectus.
We have not authorized anyone to provide information different from that contained in this
Prospectus. Neither the delivery of this Prospectus nor the sale of the securities means that the
information contained in this Prospectus is correct after the date of this Prospectus. This
Prospectus is not an offer to sell or solicitation to buy the securities in any circumstances under
which the offer or solicitation is unlawful.
PROSPECTUS SUMMARY
The following summary highlights information contained elsewhere in this Prospectus. It may
not contain all of the information that is important to you. You should read the entire Prospectus
carefully, especially the discussion regarding the risks of investing in our common stock under the
heading Risk Factors, before investing in our common stock. In this Prospectus, Aastrom, we,
us, and our refer to Aastrom Biosciences, Inc.
Business
We are a regenerative medicine company (a medical area that focuses on developing therapies
that regenerate damaged or diseased tissues or organs) that incorporated in 1989 and focuses on the
clinical development of autologous cell products (cells collected from a patient and returned to
that same patient) for the repair or regeneration of multiple human tissues, based on our
proprietary Tissue Repair Cell (TRC) technology. Our preclinical and clinical product development
programs utilize patient-derived bone marrow stem and early progenitor cell populations, and are
being investigated for their ability to aid in the regeneration of tissues such as cardiac,
vascular, bone and neural. TRC-based products have been used in over
300 patients, and are
currently in the following stages of development:
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Cardiac regeneration Cardiac Repair Cells (CRCs): |
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Dilated cardiomyopathy (DCM) (severe chronic disease of the heart): |
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U.S.: IMPACT-DCM Phase II clinical trial began treating
patients in November 2008; to date, 9 patients enrolled at three
clinical sites (The Methodist Hospital, Houston, TX, Baylor University Medical Center,
Dallas, TX and The University of Utah School of Medicine, Salt Lake
City, UT); initiation of two other clinical sites is in progress; Orphan Drug Designation from the FDA for use in
treatment of DCM; the IMPACT-DCM trial is currently on clinical hold due to a serious adverse event associated with
anesthesia management during treatment of one patient at one of the active clinical sites; an
internal review at the clinical site and a second review by the trials independent Data Safety
Monitoring Board (DSMB) determined that this event was not
related to the surgical procedure of our
CRCs |
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Germany: Encouraging data reported April 2008 from compassionate use
treatment in two patients |
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Vascular regeneration Vascular Repair Cells (VRCs): |
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Critical limb ischemia (CLI): |
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U.S.: RESTORE-CLI Phase IIb clinical trial has enrolled 51
patients; interim analysis of 12-month data for the first 30
patients expected
to occur during the 4th quarter of calendar year 2009; patient enrollment continues |
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Germany: Phase I/II investigator-sponsored clinical trial completed
enrollment and patient follow-up ongoing; positive interim data
reported October 2007; report of final data expected during the first half of
calendar year 2009 |
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Bone regeneration Bone Repair Cells (BRCs): |
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Osteonecrosis of the femoral head: |
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U.S.: ON-CORE Phase III clinical trial active; not enrolling additional
patients; Orphan Drug Designation from the FDA for use in treatment of osteonecrosis
of the femoral head |
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Spain: 9 of 10 patients treated in clinical trial; 24-month
follow-up for all patients |
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Germany: Positive data reported October 2007 from compassionate use treatment
cases follow-up ongoing |
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U.S.: Final clinical study report issued in
December 2008; TRC product showed an excellent safety profile
and the efficacy data indicated a high non-union healing rate, with bridging callus formation rates
reported in over 90% of patients 12 months post-surgery compared to 50% historically |
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Spain: Final 24-month complete for 10-patient
investigator-sponsored Phase II clinical trial; report of final data
expected during the first half of calendar year 2009 |
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Neural regeneration Neural Repair Cells (NRCs): |
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Plans for clinical program on hold |
Our platform TRC technology is based on 1) autologous cell products which are a unique cell
mixture containing large numbers of stem and early progenitor cells produced outside of the body
from a small amount of bone marrow taken from the patient, and 2) the ability to produce these
products in an automated process that meets Good Manufacturing Practice (GMP) requirements.
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We have developed a manufacturing system to produce human cells for clinical use. This
automated cell manufacturing system enables the single-pass perfusion cell culture process.
Single-pass perfusion is our patented manufacturing technology for growing large numbers of human
cells. The cell component of TRC-based products include adult stem and early progenitor cell
populations, which are capable of forming tissues such as cardiac, vascular, bone, neural, and the
hematopoietic and immune system.
All TRC-based products are produced using our cell manufacturing system in centralized
manufacturing facilities. We have one manufacturing site in the U.S. located in Ann Arbor, MI and
three contract facilities in the EU located in Stuttgart, Germany (Fraunhofer Institute for
Interfacial Engineering and Biotechnology), Bad Oeynhausen, Germany (Institute of Laboratory and
Transfusion Medicine at the Heart Center) and Barcelona, Spain (Tissue and Cell Therapy Center at
the Blood and Tissue Bank).
Since our inception, we have been in the development stage and engaged in research and product
development, conducted principally on our own behalf. Our initial business plan was to pursue our
targeted markets by commercializing our cell manufacturing system and supplies. Since 2004 we have
phased out our marketing efforts promoting the cell manufacturing system as a commercial product.
Currently, we have minimal product sales consisting of manufacturing supplies to academic
collaborators in the U.S. and cell-based products to EU-based physicians.
Our current focus is on utilizing our TRC technology to produce autologous cell-based products
for use in regenerative medicine applications. At such time as we satisfy applicable regulatory
approval requirements, we expect the sales of our TRC-based products to constitute nearly all of
our product sales revenues.
We do not expect to generate positive cash flows from our consolidated operations for at least
the next several years and then only if significant TRC-based cell product sales commence. Until
that time, we expect that our revenue sources from our current activities will consist of only
minor sales of our cell products and manufacturing supplies to our academic collaborators, grant
revenue, research funding and potential licensing fees or other financial support from potential
future corporate collaborators.
In
May 2008, we reprioritized our clinical development programs to focus primarily on
cardiovascular applications, including dilated cardiomyopathy, and critical limb ischemia. We have
discontinued further patient enrollment into our Phase III ON-CORE (osteonecrosis) bone
regeneration trial. We do not anticipate initiating new clinical bone activity, reactivating the
Phase III ON-CORE trial or initiating formal clinical trials in the neural area without additional
financial resources. While the decision to reprioritize was driven by economic factors, the
clinical programs were prioritized based on anticipated time to
market and the perceived relative clinical
and market potential. We are also exploring the possibility of entering into complementary
regenerative medicine business activities, whether through acquisition or otherwise. In addition to
the reprioritizing our development and clinical programs, we also made reductions in our staff and
reduced our overhead expenses.
We expect that we will need to raise significant additional funds or pursue strategic
transactions or other strategic alternatives in order to complete our product development programs,
complete clinical trials needed to market our products, and commercialize our products. To date, we
have financed our operations primarily through public and private sales of our equity securities,
and we expect to continue obtaining required capital in a similar manner. As a development stage
company, we have never been profitable and do not anticipate having net income unless and until
significant product sales commence. With respect to our current activities, this is not likely to
occur until we obtain significant additional funding, complete the required clinical trials for
regulatory approvals, and receive the necessary approvals to market
our products. Through December 31, 2008, we have accumulated a net
loss of approximately $187 million. We cannot provide any
assurance that we will be able to achieve profitability on a sustained basis, if at all, obtain the
required funding, obtain the required regulatory approvals, or complete additional corporate
partnering or acquisition transactions.
Corporate Information
Aastrom is incorporated under the laws of the State of Michigan. Our principal executive
offices are located at 24 Frank Lloyd Wright Drive, P.O. Box 376, Ann Arbor, Michigan 48106. Our
telephone number is (734) 930-5555. The address of our website is www.aastrom.com. Information on
our website is not part of this Prospectus.
Our Common Stock
Our common stock trades on the Nasdaq Capital Market under the symbol ASTM.
The Prospectus
This prospectus is part of a registration statement that we filed with the SEC utilizing a
shelf registration process. Under this shelf process, we may sell the securities described in
this prospectus in one or more offerings up to a total dollar amount of $50.0 million. We have
provided in this prospectus a general description of the securities we may offer. Each time we sell
securities, we will provide a prospectus supplement that will contain specific information about
the terms of that offering. We may also add, update or change in the prospectus supplement any of
the information contained in this prospectus. This prospectus, together with applicable prospectus
supplements, includes all material information relating to this offering. You should read both this
prospectus and any prospectus supplement together with the additional information described under
the heading Where You Can Find More Information.
2
RISK FACTORS
You should carefully consider the risks described below before purchasing our common stock.
Our most significant risks and uncertainties are described below; however, they are not the only
risks we face. If any of the following risks actually occur, our business, financial condition, or
results or operations could be materially adversely affected, the business of our common stock
could decline, and you may lose all or part of your investment therein. You should acquire shares
of our common stock only if you can afford to lose your entire investment.
The risk factors described below are not all inclusive. All risk factors should be considered
carefully when evaluating our business, results of operations, and financial position. We undertake
no obligation to update forward-looking statements or risk factors. There may be other risks and
uncertainties not highlighted herein that may become material factors affecting our financial
condition and business operations.
Our past losses and expected future losses cast doubt on our ability to operate profitably.
We were incorporated in 1989 and have experienced substantial operating losses since
inception. As of December 31, 2008, we have incurred a cumulative net loss totaling approximately
$187 million, and we have continued to incur losses since that date. These losses have resulted
principally from costs incurred in the research and development of our cell culture technologies
and our cell manufacturing system, general and administrative expenses, and the prosecution of
patent applications. We expect to continue to incur significant operating losses over the next
several years and at least until, and probably after, product sales increase, primarily owing to
our research and development programs, including preclinical studies and clinical trials, and the
establishment of marketing and distribution capabilities necessary to support commercialization
efforts for our products. We cannot predict with any certainty the amount of future losses. Our
ability to achieve profitability will depend, among other things, on successfully completing the
development of our product candidates, timely initiation and completion of clinical trials,
obtaining regulatory approvals, establishing manufacturing, sales and marketing arrangements with
third parties, maintaining supplies of key manufacturing components, acquisition and development of
complementary activities and raising sufficient cash to fund our operating activities. In addition,
we may not be able to achieve or sustain profitability.
The global economy and capital markets have been challenging for
the small cap biotech sector for the past year or so. This situation makes the timing and potential for future
equity financings uncertain. As of February 15, 2009, our cash and
cash equivalents
approximated $18.1 million. In part due to the fact that many of our expenditures are
discretionary in nature and could, if necessary, be delayed, we
expect that our existing cash and cash equivalents would be
sufficient to financial activities until at least February 28, 2010.
Our stock may be delisted from Nasdaq, which could affect its market price and liquidity.
We are required to meet certain qualitative and financial tests (including a minimum bid price
for our common stock of $1.00 per share) to maintain the listing of our common stock on the Nasdaq
Capital Market. On December 20, 2007, we received a deficiency letter from the Nasdaq Stock Market
indicating that for 30 consecutive trading days our common stock had a closing bid price below the
$1.00 per share minimum closing bid as required for continued listing set forth in Nasdaq
Marketplace Rule 4310(c)(4). In accordance with Nasdaq Marketplace Rule 4310(c)(8)(D), we were
provided a compliance period of 180 calendar days, or until June 17, 2008, to regain compliance
with this requirement. On June 17, 2008, we had not yet regained compliance with the requirement
and were granted an additional 180-day compliance period, or until December 15, 2008 to regain
compliance. On October 22, 2008, we received notice from Nasdaq that the period during which we
were granted to gain compliance with the bid price requirement had been suspended and that, upon
completion of the suspension period, we would have until March 20, 2009 to regain compliance with
the requirement. On January 7, 2009, we received notification from the Listings Qualifications Department of NASDAQ
that, given the continued extraordinary market conditions, NASDAQ had extended the suspension of
enforcing the rules requiring a minimum $1.00 per share closing bid price and a minimum market
value of publicly held shares through April 19, 2009. As a result of the extension of NASDAQs
suspension and the 60 days left on our previously granted compliance period, we have 60 days after
April 19, 2009 to regain compliance with the $1.00 minimum closing bid price rule in order to
remain listed on the Nasdaq Capital Market. We can regain compliance with the minimum closing bid price rule if the bid price
of our common stock closes at $1.00 per share or higher for a minimum of ten consecutive business
days during the 180-day compliance period, although Nasdaq may, in its discretion, require us to
maintain a minimum closing bid price of at least $1.00 per share for a period in excess of ten
consecutive business days (but generally no more than 20 consecutive business days) before
determining that we have demonstrated the ability to maintain long-term compliance. If we do not
regain compliance during the additional compliance period, NASDAQ will provide written notice that
our securities will be delisted from the Nasdaq Capital Market. At such time, we would be able to
appeal the delisting determination to a Nasdaq Listing Qualifications Panel.
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We cannot provide any assurance that our stock price will again recover within the permitted
grace period. If our common stock were delisted, it could be more difficult to buy or sell our
common stock and to obtain accurate quotations, and the price of our stock could suffer a material
decline. Delisting may also impair our ability to raise capital.
We may not be able to raise the required capital to conduct our operations and develop and
commercialize our products.
In
addition to our financing with Fusion Capital Fund II, LLC
(Fusion Capital), we will require substantial additional capital
resources in order to conduct our operations and develop and commercialize our products and cell
manufacturing facilities. In order to grow and expand our business, to introduce our new product
candidates into the marketplace and to acquire or develop complementary business activities, we
will need to raise a significant amount of additional funds. We will also need significant
additional funds or a collaborative partner, or both, to finance the research and development
activities of our cell product candidates for additional indications. Accordingly, we are
continuing to pursue additional sources of financing.
Our future capital requirements will depend upon many factors, including:
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continued scientific progress in our research, clinical and development programs; |
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costs and timing of conducting clinical trials and seeking regulatory approvals; |
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competing technological and market developments; |
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our ability to establish additional collaborative relationships; |
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the effect of commercialization activities and facility expansions, if and as required;
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complementary business acquisition or development opportunities. |
Because of our long-term funding requirements, we intend to try to access the public or
private equity markets if conditions are favorable to complete a financing, even if we do not have
an immediate need for additional capital at that time, or whenever we require additional operating
capital. This additional funding may not be available to us on reasonable terms, or at all. If
adequate funds are not available in the future, we may be required to further delay or terminate
research and development programs, curtail capital expenditures, and reduce business development
and other operating activities.
The
transaction with Fusion Capital is expected to provide us with some of the required capital to conduct our
operations; however, we expect that we will need additional capital. In addition, under certain
conditions, Fusion Capital will not be required to purchase our shares, including if the market price of
our common stock is less than $0.10, if we are not listed on a national exchange or the OTC
Bulletin Board or if there is a material adverse change to our business, properties, operations,
financial condition or results of operations. In addition, our ability to raise the entire $15
million will be dependent on the stock price of our common stock as we will not be able to sell
greater than 19.99% of our outstanding shares of common stock as of the date of the Purchase
Agreement without obtaining shareholder approval.
We only have the right to receive $60,000 every two business days under the Purchase Agreement
unless our stock price equals or exceeds $0.25, in which case we can sell greater amounts to Fusion
Capital as the price of our common stock increases. Since we will be
limited to 22,692,664 shares
sold to Fusion Capital, the selling price of our common stock to Fusion Capital will have to
average at least $0.66 per share for us to receive the maximum proceeds of $15.0 million. Assuming
a purchase price of $0.40 per share (the closing sale price of the
common stock on October 23, 2008) and the purchase by Fusion Capital of the full 22,692,664 shares under the Purchase
Agreement, proceeds to us would only be $9,077,066 unless we choose to register more than
22,692,664 shares, which we have the right, but not the obligation, to do. Subject to approval by
our board of directors, we have the right but not the obligation to
sell more than 22,692,664
shares to Fusion Capital. In the event we elect to sell more than
22,692,664 shares offered hereby,
we will be required to file a new registration statement covering
resale of the incremental shares and have it declared effective by the U.S.
Securities & Exchange Commission. In addition, in the event that we decide to issue more than
26,565,299, i.e. greater than 19.99% of our outstanding shares of common stock as of the date of
the Purchase Agreement, we would first be required to seek shareholder approval in order to be in
compliance with the Nasdaq Capital Market rules.
Assuming the Purchase
Price for future shares issued to Fusion Capital remain at the same average
price as the transactions to date ($0.40), we would be able to raise an additional $4.4 million of cash
proceeds per our agreement with Fusion Capital (through the issuance of the remaining 12,334,360 shares of our
common stock, which includes 1,327,026 shares related to the commitment fee).
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The extent we rely on Fusion Capital as a source of funding will depend on a number of factors
including, the prevailing market price of our common stock and the extent to which we are able to
secure working capital from other sources. Specifically, Fusion
Capital shall not have the right nor the obligation to purchase any shares of our common stock
on any business days that the market price of our common stock is less than $0.10. Even if we are
able to access the full $15.0 million under the Purchase Agreement with Fusion Capital, we will
need additional capital to fully implement our business, operating and development plans. Should
the financing we require to sustain our working capital needs be unavailable or prohibitively
expensive when we require it, the consequences could be a material adverse effect on our business,
operating results, financial condition and prospects.
We have experienced significant management turnover, and if we cannot attract and retain key
personnel, then our business will suffer.
Our success depends in large part upon our ability to attract and retain highly qualified
scientific and management personnel. We face competition for such personnel from other companies,
research and academic institutions and other entities. Further, in an effort to conserve financial
resources, we have implemented reductions in our work force on three previous occasions. As a
result of these and other factors, we may not be successful in hiring or retaining key personnel.
Our inability to replace any key employee could harm our operations.
Failure to obtain and maintain required regulatory approvals would severely limit our ability to
sell our products.
We must obtain the approval of the FDA before commercial sales of our cell product candidates
may commence in the U.S., which we believe will ultimately be the largest market for our products.
We will also be required to obtain additional approvals from various foreign regulatory authorities
to initiate sales activities of cell products in those jurisdictions, including the EU under
regulations of the EMEA. If we cannot demonstrate the safety and efficacy of our cell product
candidates, or of the cells produced in our manufacturing system, we may not be able to obtain
required regulatory approvals. If we cannot demonstrate the safety and efficacy of our product
candidates, the FDA or other regulatory authorities could delay or withhold regulatory approval of
our product candidates.
Finally, even if we obtain regulatory approval of a product, that approval may be subject to
limitations on the indicated uses for which it may be marketed. Even after granting regulatory
approval, the FDA and regulatory agencies in other countries continue to review and inspect
marketed products, manufacturers and manufacturing facilities, which may create additional
regulatory burdens. Later discovery of previously unknown problems with a product, manufacturer or
facility, may result in restrictions on the product or manufacturer, including a withdrawal of the
product from the market. Further, regulatory agencies may establish additional regulations that
could prevent or delay regulatory approval of our products.
Any changes in the governmental regulatory classifications of our products could prevent, limit or
delay our ability to market or develop our products.
The FDA establishes regulatory requirements based on the classification of a product. Because
our product development programs are designed to satisfy the standards applicable to biological
licensure for our cellular products, any change in the regulatory classification or designation
would affect our ability to obtain FDA approval of our products. Each of these cell mixtures (such
as our TRC-based products) is, under current regulations, regulated as a biologic product, which
requires a Biological License Application (BLA).
EU Directives and regulations (laws) have become effective, and have influenced the
requirements for manufacturing cell products and the conduct of clinical trials. Recent changes to
the EU Medicinal Products Prime Directive (including added annexes and new regulations) shifted
patient-derived cells to the medicinal products category, which will require Marketing
Authorizations in order to market and sell these products. These new requirements will require
clinical trials with data submission and review by one or more European regulatory bodies. There is
uncertainty about which clinical trial activities and data are required, and because of the recent
nature of these new directives, laws and regulations, there is no established precedent to
understand the timeline or other requirements for Marketing Authorization.
Our inability to complete our product development activities successfully would severely limit our
ability to operate or finance operations.
In order to commercialize our cell product candidates in the U.S. and the EU we must complete
substantial clinical trials, and obtain sufficient safety and efficacy results to support required
registration approval and market acceptance of our cell product candidates. We may not be able to
successfully complete the development of our product candidates, or successfully market our
technologies or product candidates. We, and any of our potential collaborators, may encounter
problems and delays relating to research and development, regulatory approval and intellectual
property rights of our technologies and product candidates. Our
5
research and development programs may not be successful, and our cell culture technologies and
product candidates may not facilitate the production of cells outside the human body with the
expected result. Our technologies and cell product candidates may not prove to be safe and
efficacious in clinical trials, and we may not obtain the requisite regulatory approvals for our
technologies or product candidates and the cells produced in such products. If any of these events
occur, we may not have adequate resources to continue operations for the period required to resolve
the issue delaying commercialization and we may not be able to raise capital to finance our
continued operation during the period required for resolution of that issue.
We must successfully complete our clinical trials to be able to market certain of our products.
To be able to market therapeutic cell products in the U.S. and across the EU, we must
demonstrate, through extensive preclinical studies and clinical trials, the safety and efficacy of
our processes and product candidates. If our clinical trials are not successful, our products may
not be marketable.
Our ability to complete our clinical trials in a timely manner depends on many factors,
including the rate of patient enrollment. Patient enrollment can vary with the size of the patient
population, the proximity of suitable patients to clinical sites, perceptions of the utility of
cell therapy for the treatment of certain diseases and the eligibility criteria for the study. We
have experienced delays in patient accrual in our previous and current clinical trials. If we
experience future delays in patient accrual, we could experience increased costs and delays
associated with clinical trials, which would impair our product development programs and our
ability to market our products. Furthermore, the FDA monitors the progress of clinical trials and
it may suspend or terminate clinical trials at any time due to patient safety or other
considerations.
On February 2, 2009, we reported that one patient enrolled in the IMPACT-DCM clinical trial
experienced a serious adverse event associated with anesthesia management during treatment at one
of the active clinical sites. According to the results of an internal review conducted at the
clinical site, and a second review by the trials independent Data Safety Monitoring Board (DSMB),
this event has been attributed to anesthesia administration and management in this single patient.
Furthermore, these two reviews separately determined that this event was not related to the
surgical approach or the use of our CRCs in this procedure. This patient has received appropriate
treatment, has fully recovered from this isolated event and continues to be monitored in accordance
with the study protocol. In compliance with regulatory requirements and standard operating
procedures, this event was reported directly to the FDA and we immediately took the initiative to
suspend patient enrollment at the clinical site where the event took place, pending an internal
review and the implementation of a corrective action plan. In accordance with our commitment to
the highest safety standards for participants in this trial, we have complied with a subsequent
verbal communication from the FDA that the IMPACT-DCM trial be placed on clinical hold at all trial
sites pending completion of a more comprehensive review of this event. We are working closely with
the FDA to provide any information required in order to expedite this review and to resolve this
matter so that patient enrollment into the IMPACT-DCM trial can resume as soon as possible.
Notwithstanding the hold, the FDA authorized us to proceed with the CRC treatment for one patient
previously enrolled in the IMPACT-DCM clinical trial. This patient was treated at the end of
January 2009. In addition, follow-up monitoring of patients who have previously been treated in
the IMPACT-DCM trial is continuing in accordance with the study protocol.
Our research programs are currently directed at improving TRC-based product functionality for
certain clinical indications, improving product shelf life, and decreasing the cost of
manufacturing our TRC-based products. These production process changes may alter the functionality
of our cells, and require various additional levels of experimental and clinical testing and
evaluation. Any such testing could lengthen the time before these products would be commercially
available.
Even if successful clinical results are reported for a product from a completed clinical
trial, this does not mean that the results will be sustained over time, or will be sufficient for a
marketable or regulatory approvable product.
Failure of third parties to manufacture component parts or provide limited source supplies, or the
imposition of additional regulation, would impair our new product development and our sales
activities.
We rely solely on third parties such as Astro, Ethox, Moll and Lonza to manufacture or supply
certain of our devices/manufacturing equipment, as well as component parts and other materials used
in the cell product manufacturing process. We would not be able to obtain alternate sources of
supply for many of these items on a short-term basis. If any of our key manufacturers or suppliers
fails to perform their respective obligations or if our supply of components or other materials is
limited or interrupted, we would not be able to conduct clinical trials or market our product
candidates on a timely and cost-competitive basis, if at all.
Finally, we may not be able to continue our present arrangements with our suppliers,
supplement existing relationships, establish new relationships or be able to identify and obtain
the ancillary materials that are necessary to develop our product candidates in the future. Our
dependence upon third parties for the supply and manufacture of these items could adversely affect
our ability to develop and deliver commercially feasible products on a timely and competitive
basis.
Manufacturing our cell products in centralized facilities may increase the risk that we will not
have adequate quantities of our cell products for clinical programs.
We rely on third party manufacturers, Fraunhofer Institute for Interfacial Engineering and
Biotechnology in Stuttgart, Germany, the Institute of Laboratory and Transfusion Medicine at the
Heart Center in Bad Oeynhausen, Germany, and the Tissue and Cell Therapy Center at the Blood and
Tissue Bank in Barcelona, Spain, to supply our TRC-based cell products for certain EU clinical
activities. Reliance on third party manufacturers entails risks including regulatory compliance and
quality assurance and the possible breach of the manufacturing agreement by the third party. We are
subject to similar regulatory and compliance risks at our site in Ann Arbor, Michigan. All sites
could be subject to ongoing, periodic, unannounced inspection by regulatory agencies to ensure
strict compliance with GMP regulations and other governmental regulations and corresponding foreign
standards. Our present and future manufacturers might not be able to comply with these regulatory
requirements. We do not have redundant cell manufacturing sites in the U.S. In the event our cell
manufacturing facilities are damaged or destroyed or are subject to regulatory restrictions, our
clinical trial programs and other business prospects would be adversely affected.
6
Even if we obtain regulatory approvals to sell our products, lack of commercial acceptance could
impair our business.
We will be seeking to obtain regulatory approvals to market our TRC-based cell products for
tissue repair and regeneration treatments. Even if we obtain all required regulatory approvals, we
cannot be certain that our products and processes will be accepted in the marketplace at a level
that would allow us to operate profitably. Our products may be unable to achieve commercial
acceptance for a number of reasons, such as the availability of alternatives that are less
expensive, more effective, or easier to use, the perception of a low cost-benefit ratio for the
product amongst physicians and hospitals, or an inadequate level of product support from ourselves
or a commercial partner. Our technologies or product candidates may not be employed in all
potential applications being investigated, and any reduction in applications would limit the market
acceptance of our technologies and product candidates, and our potential revenues.
The market for our products will be heavily dependent on third party reimbursement policies.
Our ability to successfully commercialize our product candidates will depend on the extent to
which government healthcare programs, such as Medicare and Medicaid, as well as private health
insurers, health maintenance organizations and other third party payors will pay for our products
and related treatments. Reimbursement by third party payors depends on a number of factors,
including the payors determination that use of the product is safe and effective, not experimental
or investigational, medically necessary, appropriate for the specific patient and cost-effective.
Reimbursement in the U.S. or foreign countries may not be available or maintained for any of our
product candidates. If we do not obtain approvals for adequate third party reimbursements, we may
not be able to establish or maintain price levels sufficient to realize an appropriate return on
our investment in product development. Any limits on reimbursement from third party payors may
reduce the demand for, or negatively affect the price of, our products. For example, in the past,
published studies suggested that stem cell transplantation for breast cancer, which constituted a
significant portion of the overall stem cell therapy market at the time, may have limited clinical
benefit. The lack of reimbursement for these procedures by insurance payors has negatively affected
the marketability of our products in this indication in the past.
Use of animal-derived materials could harm our product development and commercialization efforts.
Some of the manufacturing materials and/or components we use in, and are critical to,
implementation of our TRC technology involve the use of animal-derived products, including fetal
bovine serum. Suppliers or regulatory changes may limit or restrict the availability of such
materials for clinical and commercial use. We currently purchase all of our fetal bovine sera from
protected herds in Australia and New Zealand. These sources are considered to be the safest and
raise the least amount of concern from the global regulatory agencies. If, for example, the
so-called mad cow disease occurs in New Zealand or in Australia, it may lead to a restricted
supply of the serum currently required for the TRC-based product manufacturing processes. Any
restrictions on these materials would impose a potential competitive disadvantage for our products
or prevent our ability to manufacture TRC-based cell products. Regulatory authorities in the EU are
reviewing the safety issues related to the use of animal-derived materials, which we currently use
in our production process. The FDA has issued draft regulations for controls over bovine materials.
These proposed regulations do not appear to affect our ability to purchase the manufacturing
materials we currently use. However, the FDA may issue final regulations that could affect our
operations. We do not know what actions, if any, the authorities may take as to animal derived
materials specific to medicinal products distributed in the EU. Our inability to develop or obtain
alternative compounds would harm our product development and commercialization efforts. There are
certain limitations in the supply of certain animal-derived materials, which may lead to delays in
our ability to complete clinical trials or eventually to meet the anticipated market demand for our
cell products.
Given our limited internal manufacturing, sales, marketing and distribution capabilities, we need
to develop increased internal capability or collaborative relationships to manufacture, sell,
market and distribute our products.
We have only limited internal manufacturing, sales, marketing and distribution capabilities.
As market needs develop, we intend to establish and operate commercial-scale manufacturing
facilities, which will need to comply with all applicable regulatory requirements. We will also
need to develop new configurations of our cell manufacturing system for these facilities to enable
processes and cost efficiencies associated with large-scale manufacturing. Establishing these
facilities will require significant capital and expertise. We may need to make such expenditures
when there are significant uncertainties as to the market opportunity. Any delay in establishing,
or difficulties in operating, these facilities will limit our ability to meet the anticipated
market demand for our cell products. We intend to get assistance to market some of our future cell
products through collaborative relationships with companies with established sales, marketing and
distribution capabilities. Our inability to develop and maintain those relationships would limit
our ability to market, sell and distribute our products. Our inability to enter into successful,
long-term relationships could require us to develop alternate arrangements at a time when we need
sales, marketing or distribution capabilities to meet existing
demand. We may market one or more of our TRC-based products through our own sales force. Our
inability to develop and retain a qualified sales force could limit our ability to market, sell and
distribute our cell products.
7
The issuance of additional common stock for funding has the potential for substantial dilution.
As noted above, we will need significant additional equity funding, in addition to the
transaction with Fusion, to provide us with the capital to reach our objectives. We may enter into
financing transactions at prices which are at a substantial discount to market. Such an equity
issuance would cause a substantially larger number of shares to be outstanding and would dilute the
ownership interest of existing stockholders.
Our stock price has been volatile and future sales of substantial numbers of our shares could have
an adverse affect on the market price of our shares.
The market price of shares of our common stock has been volatile, ranging in closing price
between $0.16 and $0.76 during the twelve month period ended December 31, 2008. The price of our
common stock may continue to fluctuate in response to a number of events and factors, such as:
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clinical trial results; |
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the amount of our cash resources and our ability to obtain additional funding; |
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announcements of research activities, business developments, technological innovations or
new products by us or our competitors; |
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entering into or terminating strategic relationships; |
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changes in government regulation; |
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disputes concerning patents or proprietary rights; |
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changes in our revenues or expense levels; |
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public concern regarding the safety, efficacy or other aspects of the products or
methodologies we are developing; |
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news or reports from other stem cell, cell therapy or regenerative medicine companies; |
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reports by securities analysts; |
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status of the investment markets; |
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concerns related to management transitions; and |
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delisting from the Nasdaq Capital Market. |
Any of these events may cause the price of our shares to fall, which may adversely affect our
business and financing opportunities. In addition, the stock market in general and the market
prices for biotechnology companies in particular have experienced significant volatility recently
that often has been unrelated to the operating performance or financial conditions of such
companies. These broad market and industry fluctuations may adversely affect the trading price of
our stock, regardless of our operating performance or prospects.
If we do not keep pace with our competitors and with technological and market changes, our products
will become obsolete and our business may suffer.
The markets for our products are very competitive, subject to rapid technological changes, and
vary for different candidates and processes that directly compete with our products. Our
competitors may have developed, or could in the future develop, new technologies that compete with
our products or even render our products obsolete. As an example, in the past, published studies
have suggested that hematopoietic stem cell therapy use for bone marrow transplantation, following
marrow ablation due to chemotherapy, may have limited clinical benefit in the treatment of breast
cancer, which was a significant portion of the overall hematopoietic stem cell transplant market.
This resulted in the practical elimination of this market for our cell-based product for this
application.
Our cell manufacturing system is designed to improve and automate the processes for producing
cells used in therapeutic procedures. Even if we are able to demonstrate improved or equivalent
results, the cost or process of treatment and other factors may cause researchers and practitioners
to not use our products and we could suffer a competitive disadvantage. Finally, to the extent that
others develop new technologies that address the targeted application for our products, our
business will suffer.
8
If our patents and proprietary rights do not provide substantial protection, then our business and
competitive position will suffer.
Our success depends in large part on our ability to develop or license and protect proprietary
products and technologies. However, patents may not be granted on any of our pending or future
patent applications. Also, the scope of any of our issued patents may not be sufficiently broad to
offer meaningful protection. In addition, our issued patents or patents licensed to us could be
successfully challenged, invalidated or circumvented so that our patent rights would not create an
effective competitive barrier. Certain patent equivalents to the U.S. patents have also been issued
in other jurisdictions including Australia, Japan, the Republic of Korea, Canada and under the
European Convention. Furthermore, we rely on exclusive, world-wide licenses relating to the production of human cells
granted to us by the University of Michigan for certain of our patent rights. If we materially
breach such agreements or otherwise fail to materially comply with such agreements, or if such
agreements expire or are otherwise terminated by us, we may lose our rights under the patents held
by the University of Michigan. At the latest, each of these licenses will terminate when the patent
underlying the license expires. The first of these underlying patents will expire on March 21,
2012. We also rely on trade secrets and unpatentable know-how that we seek to protect, in part, by
confidentiality agreements with our employees, consultants, suppliers and licensees. These
agreements may be breached, and we might not have adequate remedies for any breach. If this were to
occur, our business and competitive position would suffer.
Intellectual property litigation could harm our business.
Our success will also depend in part on our ability to develop commercially viable products
without infringing the proprietary rights of others. Although we have not been subject to any filed
infringement claims, other patents could exist or could be filed which would prohibit or limit our
ability to market our products or maintain our competitive position. In the event of an
intellectual property dispute, we may be forced to litigate. Intellectual property litigation would
divert managements attention from developing our products and would force us to incur substantial
costs regardless of whether we are successful. An adverse outcome could subject us to significant
liabilities to third parties, and force us to curtail or cease the development and sale of our
products and processes.
The government maintains certain rights in technology that we develop using government grant money
and we may lose the revenues from such technology if we do not commercialize and utilize the
technology pursuant to established government guidelines.
Certain of our and our licensors research have been or are being funded in part by government
grants. As a result of such funding, the U.S. Government has established guidelines and have
certain rights in the technology developed with the grant. If we fail to meet these guidelines, we
would lose our exclusive rights to these products, and we would lose potential revenue derived from
the sale of these products.
Potential product liability claims could affect our earnings and financial condition.
We face an inherent business risk of exposure to product liability claims in the event that
the manufacture and/or use of TRC-based products during clinical trials, or after
commercialization, results in adverse events. As a result, we may incur significant product
liability exposure, which could exceed existing insurance coverage. We may not be able to maintain
adequate levels of insurance at reasonable cost and/or reasonable terms. Excessive insurance costs
or uninsured claims would increase our operating loss and affect our financial condition.
Our corporate documents and Michigan law contain provisions that may make it more difficult for us
to be acquired.
Our Board of Directors has the authority, without shareholder approval, to issue additional
shares of preferred stock and to fix the rights, preferences, privileges and restrictions of these
shares without any further vote or action by our shareholders. This authority
may have the effect of making it more difficult for a third party to acquire, or of
discouraging a third party from attempting to acquire control of our Company. This effect could
occur even if our shareholders consider the change in control to be in their best interest. In
addition, we are subject to certain anti-takeover provisions of Michigan law that could delay or
make more difficult a merger or tender offer involving our company.
We are required to evaluate our internal control over financial reporting under Section 404 of the
Sarbanes-Oxley Act of 2002 and any adverse results from such evaluation could have a negative
market reaction.
Pursuant to Section 404 of the Sarbanes-Oxley Act of 2002 (Section 404), we are required to
furnish a report by our management on our internal control over financial reporting. That report
must contain, among other matters, an assessment of the design and operating effectiveness of our
internal controls over financial reporting as of the end of the fiscal year. This assessment must
include disclosure of any material weaknesses in our internal control over financial reporting
identified by management. That report must also contain a statement that our independent registered
public accounting firm has issued an attestation report on the design and operating effectiveness
of our system of internal accounting controls over financial reporting. If in the future we are
unable to assert that our internal control over financial reporting is effective as of the end of
the then current fiscal year (or, if our independent registered public accounting firm is unable to
express an unqualified opinion on the design and operating effectiveness of our internal controls),
we could lose investor confidence in the accuracy and completeness of our financial reports, which
would have a negative effect on our stock price and our ability to raise capital.
9
RATIO OF EARNINGS TO FIXED CHARGES (1)
The following table sets forth ratios of earnings to fixed charges for the periods shown.
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Six Months Ended |
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Twelve Months Ended |
December 31, 2008 |
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June 30, 2008 |
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June 30, 2007 |
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June 30, 2006 |
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June 30, 2005 |
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June 30, 2004 |
N/A (2) |
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N/A (2) |
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N/A |
(2) |
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N/A |
(2) |
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N/A |
(2) |
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The ratio of earnings to fixed charges was computed by dividing earnings by fixed
charges. For this purpose, earnings consist of net loss before fixed charges. Fixed charges
consist of interest expense plus the interest factor in lease expenses. During the fiscal
years covered by this table, we did not have any material fixed charges or preferred stock
dividends. However, our total lease expenses, which comprised most of our total
commitments, were $574,000 for the six months ended December 31, 2008 and were $1,107,000, $679,000, $626,000, $626,000 and $616,000 for the twelve
months ended June 30, 2008, 2007, 2006, 2005, and 2004. |
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Earnings have been inadequate to cover fixed charges and total commitments. The dollar
amount of the coverage deficiency was approximately $8.0 million for the six months ended December 31, 2008 and was approximately $20.1 million, $17.6 million, $16.5
million, $11.8 million and $10.5 million for the twelve months ended June 30, 2008, 2007,
2006, 2005 and 2004, respectively. |
10
INCORPORATION BY REFERENCE
This prospectus incorporates by reference important business and financial information that we
file with the Securities and Exchange Commission and that we are not including in or delivering
with this prospectus. As the SEC allows, incorporated documents are considered part of this
prospectus, and we can disclose important information to you by referring you to those documents.
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our annual report on Form 10-K for the fiscal year ended June 30, 2008, filed with the SEC on
August 29, 2008; |
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portions of our definitive Proxy Statement for the Annual Meeting of Shareholders held on
October 17, 2008 that have been incorporated by reference into the Form 10-K; |
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our quarterly reports on Form 10-Q, filed with the
SEC on November 7, 2008 and February 6, 2009; and |
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our current reports on Form 8-K filed with the SEC on August 27, 2008, October 23, 2008 and
October 29, 2008. |
We also incorporate by reference all documents filed with the SEC under Sections 13(a), 13(c),
14 or 15(d) of the Securities Exchange Act of 1934 after the date of this prospectus and prior to
the completion or termination of this offering. Information in this prospectus supersedes related
information in the documents listed above, and information in subsequently filed documents
supersedes related information in both this prospectus and the incorporated documents.
You may request a copy of any or all of these filings, at no cost, by writing or telephoning
us at: Aastrom Biosciences, Inc., 24 Frank Lloyd Wright Drive, P.O. Box 276, Ann Arbor, Michigan
48106, attention: Investor Relations. These filings may also be obtained through the Companys
website located at http://www.aastrom.com.
You should rely only on the information incorporated by reference or provided in this
prospectus or any supplement. We have not authorized anyone else to provide you with different
information. You should not assume that information in this prospectus or any supplement is
accurate as of any date other than the date on the front of these documents.
In accordance with these rules, we have incorporated by reference the description of our
business, our securities, our properties, any legal proceedings, market price of and dividends
with respect to our common stock, our financial statements and our managements discussion and
analysis of our financial condition and results of operations. We have also incorporated by
reference disclosure with respect to our officers and directors, their compensation structure, any
related transactions with our officers and directors and our shareholders
The Company advises that there have been no material changes in the Companys affairs that
have occurred since the end of the latest fiscal year for which audited financial statements were
included in the latest Form 10-K and that have not been described in a Form 10-Q or Form 8-K filed
under the Exchange Act.
11
FORWARD-LOOKING STATEMENTS
This prospectus, including the documents that we incorporate by reference, contain
forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E
of the Securities Exchange Act. Any statements about our expectations, beliefs, plans, objectives,
assumptions or future events or performance are not historical facts and may be forward-looking.
These statements are often, but are not always, made through the use of words or phrases such as
anticipates, estimates, plans, projects, trends, opportunity, comfortable, current,
intention, position, assume, potential, outlook, remain, continue, maintain,
sustain, seek, achieve, continuing, ongoing, expects, management believes, we
believe, we intend and similar words or phrases, or future or conditional verbs such as will,
would, should, could, may, or similar expressions. Accordingly, these statements involve
estimates, assumptions and uncertainties which could cause actual results to differ materially from
those expressed in them. Any forward-looking statements are qualified in their entirety by
reference to the factors discussed throughout this report, and in particular those factors listed
under the section Risk Factors.
Because the factors referred to in the preceding paragraph could cause actual results or
outcomes to differ materially from those expressed in any forward-looking statements we make, you
should not place undue reliance on any such forward-looking statements. Further, any
forward-looking statement speaks only as of the date on which it is made, and we undertake no
obligation to update any forward-looking statement or statements to reflect events or circumstances
after the date on which such statement is made or to reflect the occurrence of unanticipated
events. New factors emerge from time to time, and it is not possible for us to predict which
factors will arise. In addition, we cannot assess the impact of each factor on our business or the
extent to which any factor, or combination of factors, may cause actual results to differ
materially from those contained in any forward-looking statements. These forward-looking statements
include statements regarding:
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potential strategic collaborations with others; |
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future capital needs; |
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adequacy of existing capital to support operations for a specified time; |
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product development and marketing plan; |
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clinical trial plans and anticipated results; |
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anticipation of future losses; |
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replacement of manufacturing sources; |
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commercialization plans; and |
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revenue expectations and operating results. |
The information contained in this Prospectus, as well as in our SEC filings, identifies
important factors that could adversely affect actual results and performance. Prospective investors
are urged to carefully consider such factors.
All forward-looking statements attributable to us are expressly qualified in their entirety by
the foregoing cautionary statements.
12
USE OF PROCEEDS
We cannot guarantee that we will receive any proceeds in connection with this offering because
we may be unable choose not to issue and sell any securities covered by this prospectus.
Unless otherwise provided in a supplement or amendment to this prospectus, we intend to use
any net proceeds from this offering, together with other available funds, for operating costs,
including continuing to conduct our clinical development programs, capital expenditures and working
capital needs and for other general corporate purposes.
We have not specifically identified the precise amounts we will spend on each of these areas
or the timing of these expenditures. The amounts actually expended for each purpose may vary
significantly depending upon numerous factors, including the amount and timing of the proceeds from
this offering, progress with clinical product development and other cell therapy application
programs. In addition, expenditures may also depend on the establishment of new collaborative
arrangements with other companies, the availability of other financing, and other factors.
We anticipate that we will be required to raise substantial additional capital to continue to
fund the clinical development of our cell therapy applications. We may raise additional capital
through additional public or private financings, as well as collaborative relationships, incurring
debt and other available sources.
THE SECURITIES WE MAY OFFER
The descriptions of the securities contained in this prospectus, together with the applicable
prospectus supplements, summarize all the material terms and provisions of the various types of
securities that we may offer. We will describe in the applicable prospectus supplement the
particular terms of the securities offered by that prospectus supplement. If we so indicate in the
applicable prospectus supplement, the terms of the securities may differ from the terms we have
summarized below. We will also include in the prospectus supplement information, where applicable,
about material United States federal income tax considerations relating to the securities and the
securities exchange, if any, on which the securities will be listed.
DESCRIPTION OF CAPITAL STOCK
The following description of our capital stock and certain provisions of our articles of
incorporation and bylaws is a summary and is qualified in its entirety by the provisions of our
articles of incorporation and bylaws.
Our authorized capital stock consists of 250,000,000 shares of common stock, no par value per
share, and 5,000,000 shares of preferred stock, no par value per share.
Common Stock
Holders of our common stock are entitled to one vote for each share held of record on all
matters submitted to a vote of shareholders and do not have cumulative voting rights. Holders of
common stock have no preemptive, redemption or conversion rights and are not subject to future
calls or assessments. No sinking fund provisions apply to our common stock. All outstanding shares
are fully-paid and non-assessable. In the event of our liquidation, dissolution or winding up,
holders of common stock are entitled to share ratably in assets available for distribution, subject
to prior distribution rights of any preferred stock then outstanding. Holders of common stock are
entitled to receive proportionately any such dividends declared by the board of directors, out of
legally available funds for dividends, subject to any preferences that may be applicable to any
shares of preferred stock that may be outstanding at that time. The rights, preferences and
privileges of holders of common stock are set forth in our restated articles of incorporation,
which may be amended by the holders of a majority of the outstanding shares of common stock.
Preferred Stock
Our Board of Directors is authorized to issue up to 5,000,000 shares of preferred stock in one
or more series without shareholder approval. Our Board of Directors may determine the rights,
preferences, privileges and restrictions, including voting rights, dividend rights, conversion
rights, redemption privileges and liquidation preferences, of each series of preferred stock.
13
The purpose of authorizing our Board of Directors to issue preferred stock in one or more
series and determine the number of shares in the series and its rights and preferences is to
eliminate delays associated with a shareholder vote on specific issuances. Examples of rights and
preferences that the Board of Directors may fix are:
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dividend rights, |
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dividend rates, |
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conversion rights, |
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voting rights, |
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terms of redemption, and |
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liquidation preferences. |
The issuance of preferred stock, while providing desirable flexibility in connection with possible
acquisitions and other corporate purposes, could make it more difficult for a third party to
acquire, or could discourage a third party from acquiring, a majority of our outstanding voting
stock. The rights of holders of our common stock described above, will be subject to, and may be
adversely affected by, the rights of any preferred stock that we may designate and issue in the
future.
We will incorporate by reference as an exhibit to the registration statement, which includes
this prospectus, the form of any certificate of designation that describes the terms of the series
of preferred stock we are offering. This description and the applicable prospectus supplement will
include:
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the title and stated value; |
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the number of shares authorized; |
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the liquidation preference per share; |
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the purchase price; |
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the dividend rate, period and payment date, and method of calculation for dividends; |
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whether dividends will be cumulative or non-cumulative and, if cumulative, the date
from which dividends will accumulate; |
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the procedures for any auction and remarketing, if any; |
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the provisions for a sinking fund, if any; |
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the provisions for redemption or repurchase, if applicable, and any restrictions on our
ability to exercise those redemption and repurchase rights; |
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any listing of the preferred stock on any securities exchange or market; |
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whether the preferred stock will be convertible into our common stock, and, if
applicable, the conversion price, or how it will be calculated, and the conversion period; |
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whether the preferred stock will be exchangeable into debt securities, and, if
applicable, the exchange price, or how it will be calculated, and the exchange period; |
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voting rights, if any, of the preferred stock; |
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preemptive rights, if any; |
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restrictions on transfer, sale or other assignment, if any; |
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whether interests in the preferred stock will be represented by depositary shares; |
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a discussion of any material United States federal income tax considerations applicable
to the preferred stock; |
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the relative ranking and preferences of the preferred stock as to dividend rights and
rights if we liquidate, dissolve or wind up our affairs; |
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any limitations on issuance of any class or series of preferred stock ranking senior to
or on a parity with the series of preferred stock as to dividend rights and rights if we
liquidate, dissolve or wind up our affairs; and |
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any other specific terms, preferences, rights or limitations of, or restrictions on,
the preferred stock. |
When we issue shares of preferred stock under this prospectus, the shares will fully be paid
and nonassessable and will not have, or be subject to, any preemptive or similar rights.
The Michigan Business Corporation Act provides that the holders of preferred stock will have
the right to vote separately as a class on any proposal involving an increase or decrease in the
authorized number of shares of that class, or changes in the powers, preferences or special rights
of holders of that preferred stock so as to affect the class adversely. This right is in addition
to any voting rights that may be provided for in the applicable certificate of designation.
Michigan Law and Certain Charter and By-Law Provisions
We are subject to certain anti-takeover provisions of the Michigan Business Corporation Act
(the MBCA) that could delay or make more difficult a merger or tender offer involving Aastrom.
Chapter 7A of the MBCA prevents, in general, an interested shareholder (defined generally as a
person owning 10% or more of a corporations outstanding voting shares) from engaging in a
business combination (as defined therein) with a Michigan corporation unless: (a) the Board of
Directors issues an advisory statement, holders of 90% of the shares of each class of stock
entitled to vote approve the transaction, and holders of two-thirds of the disinterested shares
of each class of stock approve the transaction; or (b) the interested shareholder has been an
interested shareholder for at least five years and has not acquired beneficial ownership of any
additional shares of the corporation subsequent to the transaction which resulted in such
shareholder being classified as an interested shareholder, and meets certain requirements,
including provisions relating to the fairness of the price and the form of consideration paid; or
(c) the Board of Directors, by resolution, exempts a particular interested shareholder from these
provisions prior to the interested shareholder becoming an interested shareholder. The MBCA also
contains certain other provisions that could have anti-takeover effects.
Our restated articles of incorporation eliminate the right of shareholders to act without a
meeting and do not provide for cumulative voting in the election of directors. The amendment of any
of these provisions would require approval by holders of at least a majority of the shares of our
outstanding common stock.
These and other provisions of our restated articles of incorporation could have the effect of
deterring certain takeovers or delaying or preventing certain changes in control or management of
Aastrom, including transactions in which shareholders might otherwise receive a premium for their
shares over then-current market prices.
Transfer Agent and Registrar
The transfer agent and registrar for our common stock is Continental Stock Transfer & Trust
Company.
DESCRIPTION OF DEBT SECURITIES
The following description, together with the additional information we include in any
applicable prospectus supplements, summarizes the material terms and provisions of the debt
securities that we may offer under this prospectus. While the terms we have summarized below will
apply generally to any future debt securities we may offer, we will describe the particular terms
of any debt securities that we may offer in more detail in the applicable prospectus supplement. If
we indicate in a prospectus supplement, the terms of any debt securities we offer under that
prospectus supplement may differ from the terms we describe below. Specific
agreements related to any debt securities offered will contain additional important terms and
provisions and will be incorporated by reference as an exhibit to the registration statement, which
includes this prospectus.
15
We will issue any senior notes under the senior indenture that we will enter into with a
trustee to be named in the senior indenture. We will issue any subordinated notes under the
subordinated indenture that we will enter into with a trustee to be named in the subordinated
indenture. We have filed forms of these documents as exhibits to the registration statement, which
includes this prospectus. We use the term indentures to refer to both the senior indenture and
the subordinated indenture. The indentures will be qualified under the Trust Indenture Act. We use
the term debenture trustee to refer to either the senior trustee or the subordinated trustee, as
applicable.
The following summaries of material provisions of the senior notes, the subordinated notes and
the indentures are subject to, and qualified in their entirety by reference to, all the provisions
of the indenture applicable to a particular series of debt securities. Except as we may otherwise
indicate, the terms of the senior indenture and the subordinated indenture are identical.
We conduct some of our operations through subsidiaries formed under the laws of Germany,
Ireland and Spain, respectively. Our rights and the rights of our creditors, including holders of
debt securities, to the assets of any subsidiary of ours upon that subsidiarys liquidation or
reorganization or otherwise would be subject to the prior claims of that subsidiarys creditors,
except to the extent that we may be a creditor with recognized claims against the subsidiary. Our
subsidiarys creditors would include trade creditors, debt holders, secured creditors and taxing
authorities. Except as we may provide in a prospectus supplement, neither the debt securities nor
the indentures restrict us or our subsidiary from incurring indebtedness.
General
We will describe in each prospectus supplement the following terms relating to a series of
notes:
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the title; |
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any limit on the amount that may be issued; |
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whether or not we will issue the series of notes in global form, the terms and who the
depository will be; |
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the maturity date; |
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the annual interest rate, which may be fixed or variable, or the method for determining
the rate; |
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the date interest will begin to accrue, the dates interest will be payable and the
regular record dates for interest payment dates or the method for determining such dates; |
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whether or not the notes will be secured or unsecured, and the terms of any security; |
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the terms of the subordination of any series of subordinated debt; |
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the place where payments will be payable; |
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our right, if any, to defer payment of interest and the maximum length of any such
deferral period; |
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the date, if any, after which, and the price at which, we may, at our option, redeem
the series of notes pursuant to any optional redemption provisions; |
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the date, if any, on which, and the price at which we are obligated, pursuant to any
mandatory sinking fund provisions or otherwise, to redeem, or at the holders option to
purchase, all or a portion of the series of notes; |
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whether the indenture will restrict our ability to pay dividends, or will require us to
maintain any asset ratios or reserves; |
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whether we will be restricted from incurring any additional indebtedness; |
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a discussion of any material United States federal income tax considerations applicable
to the notes; |
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the denominations in which we will issue the series of notes, if other than
denominations of $1,000 and any integral multiple thereof; and |
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any other specific terms, preferences, rights or limitations of, or restrictions on,
the debt securities. |
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Conversion or Exchange Rights
We will set forth in the prospectus supplement the terms on which a series of notes may be
convertible into or exchangeable for common stock or other securities of ours. We will include in
that prospectus supplement provisions as to whether conversion or exchange is mandatory, at the
option of the holder or at our option. We may include provisions pursuant to which the number of
shares of common stock or other securities of ours that the holders of the series of notes receive
would be subject to adjustment.
Consolidation, Merger or Sale
The indentures do not contain any covenant that restricts our ability to merge or consolidate,
or sell, convey, transfer or otherwise dispose of all or substantially all of our assets. However,
any successor to or acquirer of such assets must assume all of our obligations under the indentures
or the notes, as appropriate.
Events of Default Under the Indenture
The following are events of default under the indentures with respect to any series of notes
that we may issue:
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if we fail to pay interest when due and our failure continues for 60 days and the time
for payment has not been extended or deferred; |
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if we fail to pay the principal, or premium, if any, when due and the time for payment
has not been extended or delayed; |
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if we fail to observe or perform any other covenant contained in the notes or the
indentures, other than a covenant specifically relating to another series of notes, and our
failure continues for 60 days after we receive notice from the debenture trustee or holders
of at least 50% in aggregate principal amount of the outstanding notes of the applicable
series; and |
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if specified events of bankruptcy, insolvency or reorganization occur as to us. |
If an event of default with respect to notes of any series occurs and is continuing, the
debenture trustee or the holders of at least 50% in aggregate principal amount of the outstanding
notes of that series, by notice to us in writing, and to the debenture trustee if notice is given
by such holders, may declare the unpaid principal of, premium, if any, and accrued interest, if
any, due and payable immediately.
The holders of a majority in principal amount of the outstanding notes of an affected series
may waive any default or event of default with respect to the series and its consequences, except
defaults or events of default regarding payment of principal, premium, if any, or interest, unless
we have cured the default or event of default in accordance with the indenture. Any waiver shall
cure the default or event of default.
Subject to the terms of the indentures, if an event of default under an indenture shall occur
and be continuing, the debenture trustee will be under no obligation to exercise any of its rights
or powers under such indenture at the request or direction of any of the holders of the applicable
series of notes, unless such holders have offered the debenture trustee reasonable indemnity. The
holders of a majority in principal amount of the outstanding notes of any series will have the
right to direct the time, method and place of conducting any proceeding for any remedy available to
the debenture trustee, or exercising any trust or power conferred on the debenture trustee, with
respect to the notes of that series, provided that:
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the direction so given by the holder is not in conflict with any law or the applicable
indenture; and |
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subject to its duties under the Trust Indenture Act, the debenture trustee need not
take any action that might involve it in personal liability or might be unduly prejudicial
to the holders not involved in the proceeding. |
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a holder of the notes of any series will only have the right to institute a proceeding
under the indentures or to appoint a receiver or trustee, or to seek other remedies if: |
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the holder has given written notice to the debenture trustee of a continuing
event of default with respect to that series; |
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the holders of at least 50% in aggregate principal amount of the outstanding
notes of that series have made written request, and such holders have offered reasonable
indemnity to the debenture trustee to institute the proceeding as trustee; and |
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the debenture trustee does not institute the proceeding, and does not receive
from the holders of a majority in aggregate principal amount of the outstanding notes of
that series other conflicting directions within 60 days after the notice, request and
offer. |
These limitations do not apply to a suit instituted by a holder of notes if we default in the
payment of the principal, premium, if any, or interest on, the notes.
We will periodically file statements with the debenture trustee regarding our compliance with
specified covenants in the indentures.
Modification of Indenture; Waiver
We and the debenture trustee may change an indenture without the consent of any holders with
respect to specific matters, including:
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to fix any ambiguity, defect or inconsistency in the indenture; and |
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to change anything that does not materially adversely affect the interests of any
holder of notes of any series. |
In addition, under the indentures, the rights of holders of a series of notes may be changed
by us and the debenture trustee with the written consent of the holders of at least a majority in
aggregate principal amount of the outstanding notes of each series that is affected. However, we
and the debenture trustee may only make the following changes with the consent of each holder of
any outstanding notes affected:
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extending the fixed maturity of the series of notes; |
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reducing the principal amount, reducing the rate of or extending the time of payment of
interest, or any premium payable upon the redemption of any notes; or |
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reducing the percentage of notes, the holders of which are required to consent to any
amendment. |
Discharge
Each indenture provides that we can elect to be discharged from our obligations with respect
to one or more series of debt securities, except for obligations to:
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register the transfer or exchange of debt securities of the series; |
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replace stolen, lost or mutilated debt securities of the series; |
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maintain paying agencies; |
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hold monies for payment in trust; |
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compensate and indemnify the trustee; and |
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appoint any successor trustee. |
In order to exercise our rights to be discharged, we must deposit with the debenture trustee
money or government obligations sufficient to pay all the principal of, any premium, if any, and
interest on, the debt securities of the series on the dates payments are due.
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Form, Exchange, and Transfer
We will issue the notes of each series only in fully registered form without coupons and,
unless we otherwise specify in the applicable prospectus supplement, in denominations of $1,000 and
any integral multiple thereof. The indentures provide that we may issue notes of a series in
temporary or permanent global form and as book-entry securities that will be deposited with, or on
behalf of, The Depository Trust Company or another depository named by us and identified in a
prospectus supplement with respect to that series. See Legal Ownership of Securities for a
further description of the terms relating to any book-entry securities.
At the option of the holder, subject to the terms of the indentures and the limitations
applicable to global securities described in the applicable prospectus supplement, the holder of
the notes of any series can exchange the notes for other notes of the same series, in any
authorized denomination and of like tenor and aggregate principal amount.
Subject to the terms of the indentures and the limitations applicable to global securities set
forth in the applicable prospectus supplement, holders of the notes may present the notes for
exchange or for registration of transfer, duly endorsed or with the form of transfer endorsed
thereon duly executed if so required by us or the security registrar, at the office of the security
registrar or at the office of any transfer agent designated by us for this purpose. Unless
otherwise provided in the notes that the holder presents for transfer or exchange, we will make no
service charge for any registration of transfer or exchange, but we may require payment of any
taxes or other governmental charges.
We will name in the applicable prospectus supplement the security registrar, and any transfer
agent in addition to the security registrar, that we initially designate for any notes. We may at
any time designate additional transfer agents or rescind the designation of any transfer agent or
approve a change in the office through which any transfer agent acts, except that we will be
required to maintain a transfer agent in each place of payment for the notes of each series.
If we elect to redeem the notes of any series, we will not be required to:
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issue, register the transfer of or exchange any notes of that series during a period
beginning at the opening of business 15 days before the day of mailing of a notice of
redemption of any notes that may be selected for redemption and ending at the close of
business on the day of the mailing; or |
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register the transfer of or exchange any notes so selected for redemption, in whole or
in part, except the unredeemed portion of any notes we are redeeming in part. |
Information Concerning the Debenture Trustee
The debenture trustee, other than during the occurrence and continuance of an event of default
under an indenture, undertakes to perform only those duties as are specifically set forth in the
applicable indenture. Upon an event of default under an indenture, the debenture trustee must use
the same degree of care as a prudent person would exercise or use in the conduct of his or her own
affairs. Subject to this provision, the debenture trustee is under no obligation to exercise any of
the powers given it by the indentures at the request of any holder of notes unless it is offered
reasonable security and indemnity against the costs, expenses and liabilities that it might incur.
Payment and Paying Agents
Unless we otherwise indicate in the applicable prospectus supplement, we will make payment of
the interest on any notes on any interest payment date to the person in whose name the notes, or
one or more predecessor securities, are registered at the close of business on the regular record
date for the interest.
We will pay principal of and any premium and interest on the notes of a particular series at
the office of the paying agents designated by us, except that unless we otherwise indicate in the
applicable prospectus supplement, we will make interest payments by
check, which we will mail to the holder. Unless we otherwise indicate in a prospectus
supplement, we will designate the corporate trust office of the debenture trustee in the City of
New York as our sole paying agent for payments with respect to notes of each series. We will name
in the applicable prospectus supplement any other paying agents that we initially designate for the
notes of a particular series. We will maintain a paying agent in each place of payment for the
notes of a particular series.
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All money we pay to a paying agent or the debenture trustee for the payment of the principal
of or any premium or interest on any notes that remains unclaimed at the end of two years after
such principal, premium or interest has become due and payable will be repaid to us, and the holder
of the security thereafter may look only to us for payment of those amounts.
Governing Law
The indentures and the notes will be governed by and construed in accordance with the laws of
the State of New York, except to the extent that the Trust Indenture Act is applicable.
Subordination of Subordinated Notes
The subordinated notes will be unsecured and will be subordinate and junior in priority of
payment to some or all of our other indebtedness to the extent described in a prospectus
supplement. The subordinated indenture does not limit the amount of subordinated notes which we may
issue. It also does not limit us from issuing any other secured or unsecured debt.
DESCRIPTION OF WARRANTS
The following description, together with the additional information we may include in any
applicable prospectus supplements, summarizes the material terms and provisions of the warrants
that we may offer under this prospectus and the related warrant agreements and warrant
certificates. While the terms summarized below will apply generally to any warrants that we may
offer, we will describe the particular terms of any series of warrants in more detail in the
applicable prospectus supplement. If we indicate in the prospectus supplement, the terms of any
warrants offered under that prospectus supplement may differ from the terms described below.
Specific warrant agreements will contain additional important terms and provisions and will be
incorporated by reference as an exhibit to the registration statement, which includes this
prospectus.
General
We may issue warrants for the purchase of common stock, preferred stock and/or debt securities
in one or more series. We may issue warrants independently or together with common stock, preferred
stock and/or debt securities, and the warrants may be attached to or separate from these
securities.
We will evidence each series of warrants by warrant certificates that we will issue under a
separate warrant agreement. We will enter into the warrant agreement with a warrant agent. Each
warrant agent will be a bank that we select that has its principal office in the United States and
a combined capital and surplus of at least $50,000,000. We will indicate the name and address of
the warrant agent in the applicable prospectus supplement relating to a particular series of
warrants.
We will describe in the applicable prospectus supplement the terms of the series of warrants,
including:
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the offering price and aggregate number of warrants offered; |
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the currency for which the warrants may be purchased; |
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if applicable, the designation and terms of the securities with which the warrants are
issued and the number of warrants issued with each such security or each principal amount
of such security; |
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if applicable, the date on and after which the warrants and the related securities will
be separately transferable; |
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in the case of warrants to purchase debt securities, the principal amount of debt
securities purchasable upon exercise of one warrant and the price at, and currency in
which, this principal amount of debt securities may be purchased upon such exercise; |
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in the case of warrants to purchase common stock or preferred stock, the number of
shares of common stock or preferred stock, as the case may be, purchasable upon the
exercise of one warrant and the price at which these shares may be purchased upon such
exercise; |
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the effect of any merger, consolidation, sale or other disposition of our business on
the warrant agreement and the warrants; |
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the terms of any rights to redeem or call the warrants; |
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any provisions for changes to or adjustments in the exercise price or number of
securities issuable upon exercise of the warrants; |
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the dates on which the right to exercise the warrants will commence and expire; |
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the manner in which the warrant agreement and warrants may be modified; |
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federal income tax consequences of holding or exercising the warrants; |
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the terms of the securities issuable upon exercise of the warrants; and |
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any other specific terms, preferences, rights or limitations of or restrictions on the
warrants. |
Before exercising their warrants, holders of warrants will not have any of the rights of holders of
the securities purchasable upon such exercise, including:
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in the case of warrants to purchase debt securities, the right to receive payments of
principal of, or any premium or interest on, the debt securities purchasable upon exercise
or to enforce covenants in the applicable indenture; or |
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in the case of warrants to purchase common stock or preferred stock, the right to
receive any dividends or payments upon our liquidation, dissolution or winding up or to
exercise any voting rights. |
Exercise of Warrants
Each warrant will entitle the holder to purchase the securities that we specify in the
applicable prospectus supplement at the exercise price that we describe in the applicable
prospectus supplement. Unless we otherwise specify in the applicable prospectus supplement, holders
of the warrants may exercise the warrants at any time up to 5:00 P.M. New York time on the
expiration date that we set forth in the applicable prospectus supplement. After the close of
business on the expiration date, unexercised warrants will become void.
Holders of the warrants may exercise the warrants by delivering the warrant certificate
representing the warrants to be exercised together with specified information, and paying the
required amount to the warrant agent in immediately available funds, as provided in the applicable
prospectus supplement. We will set forth on the reverse side of the warrant certificate and in the
applicable prospectus supplement the information that the holder of the warrant will be required to
deliver to the warrant agent upon exercise.
Upon receipt of the required payment and the warrant certificate properly completed and duly
executed at the corporate trust office of the warrant agent or any other office indicated in the
applicable prospectus supplement, we will issue and deliver the securities purchasable upon such
exercise. If fewer than all of the warrants represented by the warrant certificate are exercised,
then we will issue a new warrant certificate for the remaining amount of warrants. If we so
indicate in the applicable prospectus supplement, holders of the warrants may surrender securities
as all or part of the exercise price for warrants.
Enforceability of Rights By Holders of Warrants
Each warrant agent will act solely as our agent under the applicable warrant agreement and
will not assume any obligation or relationship of agency or trust with any holder of any warrant. A
single bank or trust company may act as warrant agent for more than one issue or series of
warrants. A warrant agent will have no duty or responsibility in case of any default by us under
the applicable warrant agreement or warrant, including any duty or responsibility to initiate any
proceedings at law or otherwise, or to make any demand upon us. Any holder of a warrant may,
without the consent of the related warrant agent or the holder of any other warrant, enforce by
appropriate legal action its right to exercise, and receive the securities purchasable upon
exercise of, its warrants.
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PLAN OF DISTRIBUTION
The securities being offered may be sold in one or more transactions at fixed prices, at
prevailing market prices at the time of sale, at prices related to the prevailing market prices, at
varying prices determined at the time of sale, or at negotiated prices. These sales may be effected
at various times in one or more of the following transactions, or in other kinds of transactions:
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through underwriters for resale to the public or investors: |
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transactions on the Nasdaq Stock Market or on any national securities exchange or U.S.
inter-dealer system of a registered national securities association on which our common
stock may be listed or quoted at the time of sale; |
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in the over-the-counter market; |
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in private transactions and transactions otherwise than on these exchanges or systems
or in the over-the-counter market; |
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in connection with short sales of the shares; |
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by pledge to secure debt and other obligations; |
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through the writing of options, whether the options are listed on an options exchange
or otherwise; |
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in connection with the writing of non-traded and exchange-traded call options, in hedge
transactions and in settlement of other transactions in standardized or over-the-counter
options; |
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through a combination of any of the above transactions; or |
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any other method permitted by law. |
We may sell our securities directly to one or more purchasers, or to or through underwriters,
dealers or agents or through a combination of those methods. The related prospectus supplement will
set forth the terms of each offering, including:
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the name or names of any agents, dealers, underwriters or investors who purchase the
securities; |
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the purchase price of the securities being offered and the proceeds we will receive
from the sale; |
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the amount of any compensation, discounts commissions or fees to be received by the
underwriters, dealer or agents; |
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any over-allotment options under which underwriters may purchase additional securities
from us; |
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any discounts or concessions allowed or reallowed or paid to dealers; |
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any securities exchanges on which such securities may be listed; |
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the terms of any indemnification provisions, including indemnification from liabilities
under the federal securities laws; and |
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the nature of any transaction by an underwriter, dealer or agent during the offering
that is intended to stabilize or maintain the market price of the securities. |
In addition, any securities covered by this prospectus that qualify for sale pursuant to
Regulation S may be sold pursuant to Regulation S rather than pursuant to this prospectus.
In connection with the sale of our common stock, underwriters may receive compensation from us
or from purchasers of our common stock in the form of discounts, concessions or commissions.
Underwriters, dealers and agents that participate in the distribution of our common stock may be
deemed to be underwriters. Discounts or commissions they receive and any profit on their resale of
our common stock may be considered underwriting discounts and commissions under the Securities Act
of 1933.
We may agree to indemnify underwriters, dealers and agents who participate in the distribution
of our common stock against various liabilities, including liabilities under the Securities Act of
1933. We may also agree to contribute to payments that the underwriters, dealers or agents may be
required to make in respect of these liabilities. We may authorize dealers or other persons who act
as our agents to solicit offers by various institutions to purchase our common stock from us under
contracts that provide for payment and delivery on a future date. We may enter into these contracts
with commercial and savings banks, insurance companies, pension funds, investment companies,
educational and charitable institutions and others. If we enter into these agreements concerning
any series of our common stock, we will indicate that in the prospectus supplement or amendment.
In connection with an offering of our common stock, underwriters may engage in transactions
that stabilize, maintain or otherwise affect the price of our common stock. Specifically,
underwriters may over-allot in connection with the offering, creating a syndicate short position in
our common stock for their own account. In addition, underwriters may bid for, and purchase, our
common stock in the open market to cover short positions or to stabilize the price of our common
stock. Finally, underwriters may reclaim selling concessions allowed for distributing our common
stock in the offering if the underwriters repurchase previously distributed common stock in
transactions to cover short positions, in stabilization transactions or otherwise. Any of these
activities may stabilize or maintain the market price of our common stock above independent market
levels. Underwriters are not required to engage in any of these activities and may end any of these
activities at any time. Agents and underwriters may engage in transactions with, or perform
services for, us and our affiliates in the ordinary course of business.
22
LEGAL MATTERS
The validity of the common stock offered by this Prospectus will be passed upon for us by
Dykema Gossett PLLC, Ann Arbor, Michigan, acting as special counsel to the Company.
EXPERTS
The financial statements and managements assessment of the effectiveness of internal control
over financial reporting (which is included in Managements Report on Internal Control over
Financial Reporting) incorporated in this Prospectus by reference to the Annual Report on Form 10-K
for the year ended June 30, 2008 have been so incorporated in reliance on the report of
PricewaterhouseCoopers LLP, an independent registered public accounting firm, given on the
authority of said firm as experts in auditing and accounting.
WHERE YOU CAN FIND MORE INFORMATION
We have filed with the Securities and Exchange Commission a registration statement on Form S-3
under the Securities Act of 1933, relating to the shares of our common stock being offered by this
prospectus. For further information pertaining to our common stock and the shares of common stock
being offering by this prospectus, reference is made to such registration statement. This
prospectus constitutes the prospectus we filed as a part of the registration statement and it does
not contain all information in the registration statement, certain portions of which have been
omitted in accordance with the rules and regulations of the Securities and Exchange Commission and
certain portions of which have been incorporated by reference to our reports filed with the
Securities and Exchange Commission.
In addition, we are subject to the informational requirements of the Securities Exchange Act
of 1934, as amended, and, in accordance with such requirements, we file reports, proxy statements
and other information with the Securities and Exchange Commission relating to our business,
financial statements and other matters.
Reports and proxy and information statements filed under Section 14(a) and 14(c) of the
Securities Exchange Act of 1934 and other information filed with the Securities and Exchange
Commission as well as copies of the registration statement can be inspected and copied at the
public reference facilities maintained by the Securities and Exchange Commission at Room 1024,
Judiciary Plaza, 100 F Street, N.E., Washington, D.C. 20549. Copies of such material can also be
obtained at prescribed rates from the Public Reference Section of the Securities and Exchange
Commission at its principal office at Judiciary Plaza, 100 F Street, N.E., Washington, D.C. 20549.
Please call the Securities and Exchange Commission at 1.800.SEC.0330 for further information on the
operation of the public reference room. Such material may also be obtained electronically by
visiting the SECs web site on the Internet at http://www.sec.gov. Our common stock is traded on
the Nasdaq Capital Market under the symbol ASTM.
Copies of our filings with the Securities and Exchange Commission are also available, free of
charge, on our corporate website at http://www.aastrom.com. The other information found on our
website is not incorporated by reference into this prospectus.
You should rely only on the information contained in this Prospectus or the documents
incorporated by reference. We have not authorized anyone to provide you with any information that
is different from that contained in this Prospectus. The information contained in this Prospectus
is accurate as of the date of this Prospectus. You should not assume that there have been no
changes in the affairs of the Company since the date of this Prospectus or that the information in
this Prospectus is correct as of any time after the date of this Prospectus, regardless of the time
that this Prospectus is delivered or any sale of the common stock offered by this Prospectus is
made. This Prospectus is not an offer to sell or a solicitation of an offer to buy the shares
covered by this Prospectus in any jurisdiction where the offer or solicitation is unlawful.
DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION
FOR SECURITIES ACT LIABILITIES
As permitted by the Michigan Business Corporation Act, our Bylaws contain provisions that
permit us to indemnify our directors and officers to the full extent permitted by Michigan law and
our Restated Articles of Incorporation, as amended, contain provisions that eliminate the personal
liability of our directors in each case for monetary damages to us or our shareholders for breach
of their fiduciary duties, except to the extent that Michigan law prohibits indemnification or
elimination of liability. These provisions do not limit or eliminate our rights or the rights of
any shareholder to seek an injunction or any other non-monetary relief in the event of a breach of
a directors or officers fiduciary duty. In addition, these provisions apply only to claims
against a director or officer arising
out of his or her role as a director or officer and do not relieve a director or officer from
liability if he or she engaged in willful misconduct or a knowing violation of the criminal law or
any federal or state securities law.
The rights of indemnification provided in our Bylaws are not exclusive of any other rights
that may be available under any insurance or other agreement, by vote of shareholders or
disinterested directors or otherwise.
Insofar as indemnification for liabilities arising under the Securities Act of 1933, as
amended (the Securities Act), may be permitted to directors, officers or persons controlling us
pursuant to the foregoing provisions, we have been informed that in the opinion of the Securities
and Exchange Commission this type of indemnification is against public policy as expressed in the
Securities Act and is therefore unenforceable.
23
Part IIINFORMATION NOT REQUIRED IN PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution
The expenses payable by the Registrant in connection with the issuance and distribution of the
securities being registered (other than underwriting discounts and commissions, if any) are set
forth below. Each item listed is estimated, except for the Securities and Exchange Commission
registration fee.
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Securities and Exchange Commission registration fee |
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$ |
1,965 |
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Accounting fees and expenses |
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8,000 |
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Legal fees and expenses
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10,000 |
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Printing and engraving expenses |
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3,000 |
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Miscellaneous
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2,035 |
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Total expenses |
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$ |
25,000 |
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Item 15. Indemnification of Directors and Officers
Sections 1561 through 1571 of the Michigan Business Corporation Act (the MBCA) authorize a
corporation to grant or a court to award, indemnity to directors, officers, employees and agents in
terms sufficiently broad to permit such indemnification under certain circumstances for liabilities
(including reimbursement for expenses incurred) arising under the Securities Act of 1933.
The Bylaws of the Company provide that the Company shall, to the fullest extent authorized or
permitted by the MBCA, or other applicable law, indemnify a director or officer who was or is a
party or is threatened to be made a party to any proceeding by or in the right of the Company to
procure a judgment in its favor by reason of the fact that such person is or was a director,
officer, employee or agent of the Company, against expenses, including actual and reasonable
attorneys fees, and amounts paid in settlement incurred in connection with the action or suit, if
the indemnitee acted in good faith and in a manner the person reasonably believed to be in, or not
opposed to, the best interests of the Company or its shareholders. This section also authorizes the
Company to advance expenses incurred by any agent of the Company in defending any proceeding prior
to the final disposition of such proceeding upon receipt of an undertaking by or on behalf of the
agent to repay such amount unless it shall be determined ultimately that the agent is entitled to
be indemnified.
The Bylaws also authorize the Company to purchase and maintain insurance on behalf of any
person who is or was a director, officer, employee or agent of the Company against any liability
asserted against or incurred by such person in such capacity or arising out of such persons status
as such, regardless of whether the Company would have the power to indemnify such person against
such liability under the provisions of the MBCA.
The Company has entered into indemnification agreements with certain individuals which contain
provisions that may in some respects be broader than the specific indemnification provisions
contained under applicable law. The indemnification agreement may require the Company, among other
things, to indemnify such directors, officers and key personnel against certain liabilities that
may arise by reason of their status or service as directors, officers or employees of the Company,
to advance the expenses incurred by such parties as a result of any threatened claims or
proceedings brought against them as to which they could be indemnified, and to the maximum extent
that insurance coverage of such directors, officers and key employees under the Companys
directors and officers liability insurance policies is maintained.
Section 1209 of the MBCA permits a Michigan corporation to include in its Articles of
Incorporation a provision eliminating or limiting a directors liability to a corporation or its
shareholders for monetary damages for breaches of fiduciary duty. The enabling statute provides,
however, that liability for breaches of the duty of loyalty, acts or omissions not in good faith or
involving intentional misconduct or knowing violations of the law, or the receipt of improper
personal benefits cannot be eliminated or limited in this manner. The Companys Restated Articles
of Incorporation include a provision which eliminates, to the fullest extent permitted by the MBCA,
director liability for monetary damages for breaches of fiduciary duty.
II-1
Item 16. Exhibits
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Exhibit |
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No. |
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Description |
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3.1
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Restated Articles of Incorporation of Aastrom, as amended,
attached as Exhibit 3.1 to Aastroms Current Report on Form 8-K
filed on October 23, 2008, incorporated herein by reference. |
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3.2
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Bylaws, as amended, attached as Exhibit 3.2 to Aastroms Current
Report on Form 8-K filed on October 23, 2008, incorporated herein
by reference. |
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4.1
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Form of Senior Indenture to be
entered into with a trustee to be named.* |
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4.2
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Form of Subordinated Indenture to be entered into with a trustee to be named.* |
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5 |
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Opinion of Dykema Gossett PLLC. |
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21
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Subsidiaries of Registrant.* |
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23
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Consent of Independent Registered Public Accounting Firm. |
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24
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Powers of Attorney (included on
signature page).* |
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# |
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Management contract or compensatory plan or arrangement covering executive officers or
directors of Aastrom. |
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* |
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Filed previously. |
|
II-2
Item 17. Undertakings
(a) The undersigned Registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being made, a post-effective
amendment to this registration statement:
(i) To include any prospectus required by Section 10(a)(3) of the Securities Act of 1933;
(ii) To reflect in the prospectus any facts or events arising after the effective date of the
registration statement (or the most recent post-effective amendment thereof) which, individually or
in the aggregate, represent a fundamental change in the information set forth in the registration
statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered
(if the total dollar value of securities offered would not exceed that which was registered) and
any deviation from the low or high end of the estimated maximum offering range may be reflected in
the form of prospectus filed with the Commission pursuant to Rule 424(b) (§ 230.424(b) of this
chapter) if, in the aggregate, the changes in volume and price represent no more than a 20% change
in the maximum aggregate offering price set forth in the Calculation of Registration Fee table in
the effective registration statement.
(iii) To include any material information with respect to the plan of distribution not
previously disclosed in the registration statement or any material change to such information in
the registration statement;
Provided, however, That:
(A) Paragraphs (a)(1)(i) and (a)(1)(ii) of this section do not apply if the registration
statement is on Form S-8 (§ 230. 16b of this chapter), and the information required to be included
in a post-effective amendment by those paragraphs is contained in reports filed with or furnished
to the Commission by the Registrant pursuant to Section 13 or Section 15(d) of the Securities
Exchange Act of 1934 (15 U.S.C. 78m or 78o(d)) that are incorporated by reference in this
registration statement; and
(B) Paragraphs (a)(1)(i), (a)(1)(ii) and (a)(1)(iii) of this section do not apply if the
registration statement is on Form S-3 (§ 239.13 of this chapter) or Form F-3 (§ 239.33 of this
chapter) and the information required to be included in a post-effective amendment by those
paragraphs is contained in reports filed with or furnished to the Commission by the Registrant
pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934 that are
incorporated by reference in the registration statement, or is contained in a form of prospectus
filed pursuant to Rule 424(b) (§ 230.424(b) of this chapter) that is part of the registration
statement.
(C) Provided further, however, that paragraphs (a)(1)(i) and (a)(1)(ii) do not apply if the
registration statement is for an offering of asset-backed securities on Form S-1 (§ 239.11 of this
chapter) or Form S-3 (§ 239.13 of this chapter), and the information required to be included in a
post-effective amendment is provided pursuant to Item 1100(c) of Regulation AB (§ 229.1100(c)).
(2) That, for the purpose of determining any liability under the Securities Act of 1933, each
such post-effective amendment shall be deemed to be a new registration statement relating to the
securities offered therein, and the offering of such securities at that time shall be deemed to be
the initial bona fide offering thereof.
(3) To remove from registration by means of a post-effective amendment any of the securities
being registered which remain unsold at the termination of the offering.
(b) The undersigned Registrant hereby undertakes that, for purposes of determining any liability
under the Securities Act of 1933, each filing of the Registrants annual report pursuant to Section
13(a) or Section 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing
of an employee benefit plans annual report pursuant to Section 15(d) of the Securities Exchange
Act of 1934) that is incorporated by reference in this registration statement shall be deemed to be
a new registration statement relating to the securities offered therein, and the offering of such
securities at that time shall be deemed to be the initial bona fide offering thereof.
(c) Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be
permitted to directors, officers and controlling persons of the Registrant pursuant to the
foregoing provisions, or otherwise, the Registrant has been advised that in the opinion of the
Securities and Exchange Commission such indemnification is against public policy as expressed in
the Act and is, therefore, unenforceable. In the event that a claim for indemnification against
such liabilities (other than the payment by the Registrant of expenses incurred or paid by a
director, officer or controlling person of the Registrant in the successful defense of any action,
suit or proceeding) is asserted by such director, officer or controlling person in connection with
the securities being registered, the
Registrant will, unless in the opinion of its counsel the matter has been settled by controlling
precedent, submit to a court of appropriate jurisdiction the question whether such indemnification
by it is against public policy as expressed in the Act and will be governed by the final
adjudication of such issue.
II-3
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the Registrant has duly caused
this registration statement to be signed on its behalf by the undersigned, thereunto duly
authorized, in Ann Arbor, Michigan on February 19, 2009.
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AASTROM BIOSCIENCES, INC.
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By |
/s/ George W. Dunbar, Jr. |
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George W. Dunbar, Jr. |
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President and Chief Executive Officer |
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Pursuant to the requirements of the Securities Act of 1933, this Registration Statement has
been signed by the following persons in the capacities and on the dates indicated.
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Signature |
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Title |
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Date |
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/s/ George W. Dunbar, Jr.
George
W. Dunbar, Jr.
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President and CEO (Principal
Executive,
Financial and Accounting
Officer)
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February 19, 2009 |
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Chairman of the Board
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February 19, 2009 |
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Director
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February 19, 2009 |
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Director
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February 19, 2009 |
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Director
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February 19, 2009 |
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Director
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February 19, 2009 |
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* |
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George W. Dunbar, Jr., by signing his name hereto, signs this
document on behalf of each of the persons indicated by an asterisk
above pursuant to powers of attorney duly executed by such persons
and previously filed with the Securities and Exchange Commission as
part of this registration statement. |
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By: |
/s/ George W. Dunbar, Jr. |
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George W. Dunbar, Jr. |
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February 19, 2009 |
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II-4
exv5
Exhibit 5
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Dykema Gossett PLLC
2723 South State Street
Suite 400
Ann Arbor, Michigan 48104
www.dykema.com
Tel: (734) 214-7660
Fax: (734) 214-7696 |
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February 17,
2009
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Aastrom Biosciences, Inc. |
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24 Frank Lloyd Wright Dr. |
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Ann Arbor, Michigan 48105 |
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Re: Aastrom Biosciences, Inc. Registration Statement on Form S-3
Ladies and Gentlemen:
We have acted as special counsel to Aastrom Biosciences, Inc., a Michigan corporation (the
Company), in connection with the filing with the Securities and Exchange Commission (the
Commission) of an Amendment No. 1 to the registration statement (the Registration Statement) of the Company on Form S-3
under the Securities Act of 1933, as amended (the Act). The Registration Statement relates to
the Companys:
|
(i) |
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common stock, no par value per share (the Common Stock); |
|
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(ii) |
|
preferred stock, no par value per share (the Preferred
Stock); |
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(iii) |
|
senior debt securities (the Senior Debt Securities) to be
issued under the senior indenture (the Senior Indenture); |
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(iv) |
|
subordinated debt securities (the Subordinated Debt
Securities and, together with the Senior Debt Securities, the Debt
Securities) to be issued under the subordinated indenture (the Subordinated
Indenture and, together with the Senior Indenture, the Indentures); and |
|
|
(iv) |
|
warrants representing rights to purchase, Common Stock,
Preferred Stock or Debt Securities (the Warrants); |
(collectively, the Common Stock, the Preferred Stock, the Debt Securities and the Warrants are
referred to herein as the Securities); all of which may be issued from time to time on a delayed
or continuous basis pursuant to Rule 415 under the Act at an aggregate initial offering price not
to exceed $50,000,000.
We have been advised by the Company that:
California | Illinois | Michigan | Texas | Washington D.C.
Aastrom Biosciences, Inc.
February 17, 2009
Page 2
|
A. |
|
The rights, preferences, privileges and restrictions, including voting rights,
dividend rights, conversion rights, redemption privileges and liquidation privileges of
each series of Preferred Stock will be set forth in a certificate of designation to be
approved by the Companys Board of Directors, or in an amendment to the Companys
Restated Articles of Incorporation to be approved by the Companys Board of Directors
and shareholders, and that one or both of these documents will be filed either as an
exhibit to an amendment to the Registration Statement to be filed after the date of
this opinion or as an exhibit to a Current Report on Form 8-K to be filed after the
Registration Statement has become effective; |
|
|
B. |
|
The Senior Debt Securities may be issued pursuant to an Indenture between the
Company and a trustee to be named in such Indenture, which Indenture will be filed
either as an exhibit to an amendment to the Registration Statement to be filed after
the date of this opinion or as an exhibit to a Current Report on Form 8-K to be filed
after the Registration Statement has become effective; |
|
|
C. |
|
The Subordinated Debt Securities may be issued pursuant to an Indenture between
the Company and a trustee to be named in such Indenture, which Indenture will be filed
either as an exhibit to an amendment to the Registration Statement to be filed after
the date of this opinion or as an exhibit to a Current Report on Form 8-K to be filed
after the Registration Statement has become effective; |
|
|
D. |
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The particular terms of any Debt Securities will be set forth in a supplement
to the prospectus forming a part of the Registration Statement; and |
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E. |
|
Warrants may be issued pursuant to a warrant agreement to be entered into
between the Company and a bank as warrant agent (the Warrant Agreement). The Warrant
Agreement will be filed either as an exhibit to an amendment to the Registration
Statement to be filed after the date of this opinion or as an exhibit to a Current
Report on Form 8-K to be filed after the Registration Statement has become effective
and the particular terms of any series of Warrants will be set forth in a supplement to
the prospectus forming a part of the Registration Statement. |
In rendering the opinions set forth below, we have assumed that (i) all information contained
in all documents reviewed by us is true and correct; (ii) all signatures on all documents examined
by us are genuine; (iii) all documents submitted to us as originals are authentic and all documents
submitted to us as copies conform to the originals of those documents; (iv) each
California | Illinois | Michigan | Texas | Washington D.C.
Aastrom Biosciences, Inc.
February 17, 2009
Page 3
natural person signing any document reviewed by us had the legal capacity to do so; (v) the
Registration Statement, and any amendments thereto (including post-effective amendments) will have
become effective and comply with all applicable laws; (vi) a prospectus supplement will have been
prepared and filed with the Commission describing the Securities offered thereby; (vii) all
Securities will be issued and sold in compliance with applicable federal and state securities laws
and in the manner stated in the Registration Statement and the applicable prospectus supplement;
(viii) a definitive purchase, underwriting or similar agreement with respect to any Securities
offered will have been duly authorized and validly executed and delivered by the Company and the
other parties thereto; (ix) the Company has reserved from its authorized but unissued and
unreserved shares of stock a number sufficient to issue all Securities; (x) the certificates
representing the Securities will be duly executed and delivered; and (xi) if the holders of the
Debt Securities are granted rights to inspect corporate books and records and to vote in the
election of directors or any matters on which shareholders of the Company may vote, such rights are
set forth in the Companys Restated Articles of Incorporation or the Restated Articled of
Incorporation grant to the Companys Board of Directors the power to confer such voting or
inspection rights and the Companys Board of Directors has conferred such rights.
We have examined the Registration Statement, including the exhibits thereto, and such other
documents, corporate records, and instruments and have examined such laws and regulations as we
have deemed necessary for purposes of rendering the opinions set forth herein. Based upon such
examination and subject to the further provisions hereof, we are of the following opinion:
1. The Common Stock will be validly issued, fully paid and nonassessable, provided that (i)
the Companys Board of Directors or a properly authorized committee thereof has specifically
authorized the issuance of such Common Stock in exchange for a consideration that the Board of
Directors or such committee determines as adequate (any such specific authorization of Securities
being Authorizing Resolutions), (ii) the terms of the offer and sale of the Common Stock have
been duly established in conformity with the Companys Restated Articles of Incorporation and
By-laws and do not violate any applicable law or result in a default under or breach of any
agreement or instrument binding on the Company and comply with any requirement or restriction
imposed by any court or governmental body having jurisdiction over the Company, (iii) the Company
has received the consideration provided for in the applicable Authorizing Resolutions, and (iv)
certificates evidencing the shares of Common Stock have been duly executed by the duly authorized
officers of the Company in accordance with applicable law.
2. The Preferred Stock will be validly issued, fully paid and nonassessable, provided that (i)
such Preferred Stock is specifically authorized for issuance by Authorizing Resolutions, (ii) the
rights, preferences, privileges and restrictions of the Preferred Stock have been
California | Illinois | Michigan | Texas | Washington D.C.
Aastrom Biosciences, Inc.
February 17, 2009
Page 4
established in conformity with applicable law, (iii) an appropriate certificate of designation
approved by the Companys Board of Directors, or an amendment to the Companys Restated Articles of
Incorporation approved by the Companys Board of Directors and shareholders, has been filed with
the Department of Labor and Economic Growth, Bureau of Commercial Services, of the State of
Michigan, (iv) the terms of the offer, issuance and sale of shares of such class or series of
Preferred Stock have been duly established in conformity with the Companys Restated Articles of
Incorporation and By-laws and do not violate any applicable law or result in a default under or
breach of any agreement or instrument binding upon the Company and comply with any requirement or
restriction imposed by any court or governmental body having jurisdiction over the Company, (v) the
Company has received the consideration provided for in the applicable Authorizing Resolutions, and
(vi) certificates evidencing the shares of Preferred Stock have been duly executed by the duly
authorized officers of the Company in accordance with applicable law.
3. The Debt Securities, when issued and sold in accordance with the applicable Indenture and
any applicable purchase or agency agreement will constitute valid and legally binding obligations
of the Company, provided that (i) such Debt Securities are specifically authorized for issuance by
Authorizing Resolutions, (ii) the applicable Indenture conforms with applicable law and is
enforceable in accordance with its terms, (iii) the terms of the Debt Securities and of their issue
and sale have been duly established in conformity with the applicable Indenture, the Companys
Restated Articles of Incorporation and Authorizing Resolutions and do not violate any applicable
law or result in a default under or breach of any agreement or instrument binding upon the Company
and comply with any requirement or restriction imposed by any court or governmental body having
jurisdiction over the Company, (iv) the applicable Indenture and any supplemental indenture in
respect of such Debt Securities has been duly authorized, executed and delivered by each party
thereto and such Debt Securities have been duly executed and authenticated in accordance with the
applicable Indenture and offered, issued and sold as contemplated in the Registration Statement,
and (v) the Debt Securities have been duly delivered to the purchasers thereof, in consideration
for which the Company has received the consideration provided for in the applicable Authorizing
Resolutions.
4. The Warrants will constitute valid and legally binding obligations of the Company, provided
that (i) such Warrants are specifically authorized for issuance by Authorizing Resolutions which
include the terms upon which the Warrants are to be issued, their form and content and the
consideration for which shares are to be issued upon exercise of the Warrants, (ii) the Warrant
Agreement relating to the Warrants has been duly authorized, executed and delivered and is
enforceable in accordance with its terms, (iii) the terms of the of the offer, issuance and sale of
such Warrants have been duly established in conformity with the Warrant Agreement, (iv) the Warrant
Agreement and the offer, issuance and sale of the Warrants do not violate any applicable law or
result in a default under or breach of any agreement or
California | Illinois | Michigan | Texas | Washington D.C.
Aastrom Biosciences, Inc.
February 17, 2009
Page 5
instrument binding upon the Company and comply with any requirement or restriction imposed by
any court or governmental body having jurisdiction over the Company, (v) such Warrants have been
duly executed and countersigned in accordance with the Warrant Agreement and offered, issued and
sold as contemplated in the Registration Statement, the applicable Authorizing Resolutions and the
Warrant Agreement, and (vi) the Company has received the consideration provided for in the
applicable Authorizing Resolutions.
The foregoing opinions are qualified to the extent that the enforceability of any document,
instrument or Securities may be limited by or subject to bankruptcy, insolvency, fraudulent
transfer or conveyance, reorganization, moratorium or other similar laws relating to or affecting
creditors rights generally, and general equitable or public policy principles.
We express no opinions concerning (i) the validity or enforceability of any provisions
contained in Indentures that purport to waive or not give effect to rights to notices, defenses,
subrogation or other rights or benefits that cannot be effectively waived under applicable law;
(ii) the validity or enforceability of any provisions contained in the Warrant Agreement that
purport to waive or not give effect to rights to notices, defenses, subrogation or other rights or
benefits that cannot be effectively waived under applicable law; or (iii) any securities into which
the Preferred Stock, Debt Securities and the Warrants may be convertible or exercisable.
We have relied as to certain matters on information obtained from public officials and
officers of the Company.
It is understood that this opinion is to be used only in connection with the offer and sale of
Common Stock, Preferred Stock, Debt Securities and Warrants while the Registration Statement is in
effect.
Please note that we are opining only as to the matters expressly set forth herein, and no
opinion should be inferred as to any other matters. This opinion is based upon currently existing
statutes, rules, regulations and judicial decisions, and we disclaim any obligation to update this
opinion or otherwise advise you of any change in any of these sources of law or subsequent legal or
factual developments which might affect any matters or opinions set forth herein.
You have informed us that you intend to issue Securities from time to time on a delayed or
continuous basis, and this opinion is limited to the laws as in effect on the date hereof. We
understand that prior to issuing any Securities pursuant to the Registration Statement (i) you will
advise us in writing of the terms thereof and (ii) you will afford us an opportunity to (x) review
the operative documents pursuant to which such Securities are to be issued or sold and (y) file
such supplement or amendment to this opinion (if any) as we may reasonably consider necessary or
appropriate.
California | Illinois | Michigan | Texas | Washington D.C.
Aastrom Biosciences, Inc.
February 17, 2009
Page 6
The forgoing opinions are limited to the laws of the state of Michigan and the federal laws of
the United States. We express no opinion and make no representation with respect to the law of any
other jurisdiction.
We hereby consent to the reference to our firm under the caption Legal Matters in the
Registration Statement and to the filing of this opinion as an exhibit to the Registration
Statement. Such consent does not constitute a consent under Section 7 of the Act, because we have
not certified any part of such Registration Statement and do not otherwise come within the
categories of persons whose consent is required under Section 7 of the Act or the rules and
regulations of the Commission promulgated thereunder.
Very truly yours,
Dykema Gossett pllc
/s/ Dykema
Gossett PLLC
California | Illinois | Michigan | Texas | Washington D.C.
exv23
EXHIBIT 23
Consent of Independent Registered Public Accounting Firm
We hereby
consent to the incorporation by reference in this Amendment
No. 1 to Registration Statement on Form S-3 (No. 333-155739) of
our report dated August 29, 2008 relating to the financial statements and the effectiveness of
internal control over financial reporting, which appears in Aastrom Biosciences, Inc.s Annual
Report on Form 10-K for the year ended June 30, 2008. We also consent to the references to us
under the heading Experts in such Registration Statement.
/s/ PricewaterhouseCoopers LLP
PricewaterhouseCoopers LLP
Detroit, Michigan
February 19, 2009