<PAGE>
AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON DECEMBER 29, 2000
REGISTRATION NO. 333-51350
================================================================================
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
Amendment No. 1
FORM S-3
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
AASTROM BIOSCIENCES, INC.
(Exact Name of Registrant as Specified in Its Charter)
MICHIGAN 94-3096597
(State or Other Jurisdiction (IRS Employer
of Incorporation or Organization) Identification 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 Registrant's Principal Executive Offices)
R. DOUGLAS ARMSTRONG, PH.D.
PRESIDENT AND CHIEF EXECUTIVE OFFICER
AASTROM BIOSCIENCES, INC.
24 FRANK LLOYD WRIGHT DRIVE
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)
COPIES TO:
DOUGLAS J. REIN, ESQ.
GRAY CARY WARE & FREIDENRICH LLP
4365 EXECUTIVE DRIVE, SUITE 1600
SAN DIEGO, CA 92121
TELEPHONE: (858) 677-1400
FACSIMILE: (858) 677-1477
APPROXIMATE DATE OF COMMENCEMENT OF PROPOSED SALE TO THE PUBLIC:
From time to time as described in the Prospectus.
If the only securities being registered on this Form are being offered pursuant
to dividend or interest reinvestment plans, please check the following box. [_]
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. [X]
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. [_]
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. [_]
If delivery of the prospectus is expected to be made pursuant to Rule 434,
please check the following box.[_]
<TABLE>
<CAPTION>
CALCULATION OF REGISTRATION FEE
=======================================================================================================================
PROPOSED PROPOSED
AMOUNT MAXIMUM MAXIMUM AMOUNT OF
TITLE OF SHARES TO BE AGGREGATE AGGREGATE REGISTRATION
TO BE REGISTERED REGISTERED PRICE PER UNIT (1) OFFERING PRICE (1) FEE (2)
-----------------------------------------------------------------------------------------------------------------------
<S> <C> <C> <C> <C>
Common Stock 7,700,000 $0.96 $7,392,000 $1,848
($0 par value)
=======================================================================================================================
</TABLE>
(1) Estimated, pursuant to Rule 457(c), solely for the purpose of calculating
the registration fee based on the average of the high and low prices for the
common stock, as reported on the Nasdaq National Market on December 27,
2000.
(2) $2,130 has paid with the initial filing
THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR DATES
AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT SHALL FILE
A FURTHER AMENDMENT WHICH 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.
================================================================================
<PAGE>
SUBJECT TO COMPLETION, DATED DECEMBER 29, 2000
The information in this prospectus is not complete and may be changed. The
selling holder may not sell these securities under this prospectus until the
registration statement filed with the Securities and Exchange Commission is
effective. This prospectus is not an offer to sell nor does it seek an offer to
buy these securities in any state where the offer and sale would not be
permitted.
PROSPECTUS
----------
AASTROM BIOSCIENCES, INC.
7,700,000 SHARES OF COMMON STOCK
We may from time to time issue up to 7,700,000 shares of our common stock.
We will specify in the accompanying prospectus supplement or amendment the terms
of any such offering. We may sell these common shares to or through underwriters
and also to other purchasers or through agents. We will set forth the names of
any underwriters or agents in the accompanying prospectus supplement or
amendment.
You should read this document and any prospectus supplement or amendment
carefully before you invest.
Our common stock is traded on the Nasdaq National Market under the symbol
"ASTM." On December 27, 2000, the last reported sale price for our common stock
was $.90625 per share.
________________
INVESTING IN THE COMMON STOCK INVOLVES A HIGH DEGREE OF RISK. YOU SHOULD
CONSIDER CAREFULLY THE RISK FACTORS BEGINNING ON PAGE 3 OF THIS PROSPECTUS
BEFORE MAKING A DECISION TO PURCHASE OUR STOCK.
________________
NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES
COMMISSION HAS APPROVED OR DISAPPROVED 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 DECEMBER __, 2000.
<PAGE>
================================================================================
You should rely only on the information provided or incorporated by reference in
this prospectus. We have not authorized anyone to provide you with additional or
different information. This document may only be used where it is legal to sell
these securities. You should not assume that any information in this prospectus
is accurate as of any date other than the date of this prospectus.
================================================================================
======================================================
TABLE OF CONTENTS
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Page
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<S> <C>
Our Business................................ 1
Risk Factors................................ 3
Where You Can Find More Information......... 10
Plan of Distribution........................ 11
Use of Proceeds............................. 12
Legal Matters............................... 12
Experts..................................... 12
</TABLE>
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OUR BUSINESS
Because this is a summary, it does not contain all the information
about us that may be important to you. You should read the more detailed
information and the financial statements and related notes which are
incorporated by reference in this prospectus.
Aastrom
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Aastrom Biosciences, Inc. is developing proprietary process
technologies and devices intended for a broad range of cell therapy
applications. The AastromReplicell(TM) System is our lead product under
development, and consists of a clinical cell culture system that operates
single-use therapy kits tailored for patient therapy in the emerging cell
therapy market. In April 1999, we began European commercialization and a
lead U.S. pivotal clinical trial of the AastromReplicell(TM) System for use
in stem cell therapy was in process. However, in October 1999, we suspended
marketing efforts and our U.S. clinical development activities until we
could obtain additional funding. With recently received funding, we have
recommenced our U.S. clinical development program, and we are resuming
pilot-scale marketing activities in Europe with targeted medical centers.
For the current applications in stem cell therapy, we believe that the
AastromReplicell(TM) System method of producing cells will be a cost-
effective, less invasive and less time-consuming alternative, or
improvement to, currently available stem cell collection methods and may
enhance the clinical utility of umbilical cord blood transplants in
patients with certain forms of leukemia and other blood diseases by
expanding the number of cells available for transplant. Further, the
AastromReplicell(TM) System is designed as a platform product which
implements our pioneering cell production technology. Accordingly, we
believe that the AastromReplicell(TM) System can be modified to produce a
wide variety of other cell types for selected emerging therapies currently
in development, and we either have, or plan to initiate, development
programs targeted towards some of these emerging therapies.
Our business model builds on two components: (i) proprietary
procedures and devices to enable certain types of stem cells and other
types of human cells to be produced with superior biological capabilities
as compared with standard cell culture approaches, and (ii) the
AastromReplicell(TM) System clinical platform that is designed to
standardize and enable an effective commercialization pathway for bringing
therapeutic cell production to medical practice. The product configuration
of the AastromReplicell(TM) System consists of an instrumentation platform,
to be integrated within the hospital or other centralized facility, that
can operate a variety of single-use therapy kits that are specific to the
desired medical application. This is intended to provide a product pathway
for each cell therapy that is similar to a pharmaceutical product including
regulatory approval, reimbursement, marketing and pricing. We believe that
the product design of the AastromReplicell(TM) System will allow us to
develop additional cell therapy kits to provide product standardization for
a number of emerging cell therapies being developed by other researchers.
We are currently developing our SC-I Therapy Kit, CB-I Therapy Kit and
CB-II Therapy Kit for use in stem cell therapy in cancer patients. Stem
cell therapy is a form of cell therapy used to restore blood and immune
system function to cancer patients following chemotherapy or radiation
therapy. Current stem cell collection methods, including bone marrow
harvest and peripheral blood progenitor cell mobilization, can be costly,
invasive and time-consuming for both medical personnel and patients. We
believe that the AastromReplicell(TM) System may offer significant
advantages over traditional stem cell collection methods in settings where
it is difficult to obtain the desired quantity of cells for transplant
using the current cell collection methods. The AastromReplicell(TM) System
is intended to be used to produce cells for stem cell therapy from a small
starting volume of bone marrow or umbilical cord blood cells. Although we
may not market the AastromReplicell(TM) System in the United States for
stem cell therapy unless and until approval is obtained from the U.S. Food
and Drug Administration (FDA), production-level versions of the
AastromReplicell(TM) System have been completed and we have obtained
permission to affix the CE Mark to such versions. CE Mark approval allows
for marketing of the product in Europe. We may also market the
AastromReplicell(TM) System in the U.S. for research and investigational
use.
1
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We have also recently initiated development programs for
AastromReplicell(TM) System therapy kits for the production of bone-forming
cells and for dendritic cells. The new OC-I Therapy Kit is intended for the
production of bone-forming cells for the treatment of patients with
degenerative bone diseases such as osteoporosis. We recently initiated our
first Phase I/II-Pilot clinical study for the OC-I Therapy Kit in patients
with severe osteoporosis. Our new DC-I Therapy Kit is being developed for
the production of human dendritic cells to be used in cancer immunotherapy
applications. Recent clinical studies conducted by others have indicated
that modified dendritic cells may be an important new way to treat certain
cancers.
Our principal executive offices are located at 24 Frank Lloyd Wright
Drive, P. O. Box 376, Ann Arbor, MI 48106. Our telephone number is (734)
930-5555.
2
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RISK FACTORS
You should carefully consider the following risk factors before
purchasing our common stock. The risks and uncertainties described below
are not the only ones we face. There may be additional risks and
uncertainties that are not known to us or that we do not consider to be
material at this time. If the events described in these risks occur, our
business, financial condition and results of operations would likely
suffer. This prospectus contains forward-looking statements which involve
risks and uncertainties. Our actual results may differ significantly from
the results discussed in the forward-looking statements. This section
discusses some of the factors that might cause those differences.
If We Cannot Complete Our Product Development Activities Successfully, Our
Ability to Operate or Finance Operations Will Be Severely Limited.
Commercialization in the United States of our lead product candidate,
the AastromReplicell(TM) Cell Production System, will require additional
research and development as well as substantial clinical trials. While we
have commenced initial marketing on a very limited basis of the
AastromReplicell(TM) System in Europe, we believe that the United States
will be the principal market for our products. We may not be able to
successfully complete development of the AastromReplicell(TM) System or our
other 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 research and development programs may not be successful,
and our cell culture technologies and product candidates may not facilitate
the ex vivo production of cells with the expected biological activities in
humans. Our technologies and product candidates may not prove to be safe
and efficacious in clinical trials, and we may not obtain the intended
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 Cannot Be Certain That We Will Be Able to Raise the Required Capital to
Conduct Our Operations and Develop Our Products.
We will require substantial capital resources in order to conduct our
operations and develop our products. In October 1999, we were forced to
reduce operations based on our declining level of capital resources and our
limited financing alternatives available at that time. Although we have
started to restore operating activities, the previous reduction in our
operating activities has negatively affected our ability to develop our
products and has delayed our product development programs. Based on current
funding and anticipated operating activities, we expect that our available
cash and expected interest income will be sufficient to finance our current
activities through the end of our fiscal year ending June 30, 2001. This is
a forward-looking statement and could be negatively affected by funding
limitations, the implementation of additional research and development
programs and other factors discussed under this heading. We are currently
pursuing additional sources of financing. If we cannot obtain additional
funding prior to that time, we will be forced to make substantial
reductions in the scope and size of our operations, and may be forced to
curtail activities that we currently plan to resume. In order to grow and
expand our business, and to introduce our product candidates into the
marketplace, we will need to raise additional funds. We will also need
additional funds or a collaborative partner, or both, to finance the
research and development activities of our new product candidates for the
production of additional cell types.
Our future capital requirements will depend upon many factors,
including:
. continued scientific progress in its research and development
programs;
. costs and timing of conducting clinical trials and seeking
regulatory approvals and patent prosecutions;
. competing technological and market developments;
. the ability of Aastrom to establish additional collaborative
relationships; and
. effective commercialization activities and facility expansions if
and as required.
3
<PAGE>
Because of our long-term funding requirements, we may attempt to access the
public or private equity markets if and whenever conditions are favorable,
even if we do not have an immediate need for additional capital at that
time. Further, we may enter into financing transactions at rates which are
at a substantial discount to market. This additional funding may not be
available to us on reasonable terms, or at all. If adequate funds are not
available, we may be required to further delay or terminate research and
development programs, curtail capital expenditures, and reduce business
development and other operating activities.
We Must Successfully Complete Our Clinical Trials to be Able to Market Our
Products.
To be able to market products in the United States, we must
demonstrate, through extensive preclinical studies and clinical trials, the
safety and efficacy of our processes and product candidates, together with
the cells produced by such processes in such products, for application in
the treatment of humans. We are currently conducting clinicals trial to
demonstrate the safety and biological activity of patient-derived cells
produced in the AastromReplicell System(TM). Depending on the availability
of resources, we intend to commence at least one additional clinical trial
to demonstrate the safety and biological activity of umbilical cord blood
cells produced in the AastromReplicell(TM) System. 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 stem
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 U.S. Food and Drug
Administration ("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.
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
product candidates may commence in the United States, which we believe will
be the principal market for our products. We may also be required to obtain
additional approvals from foreign regulatory authorities to continue or
increase our sales activities in those jurisdictions. If we cannot
demonstrate the safety, reliability and efficacy of our product candidates,
or of the cells produced in such products, we may not be able to obtain
required regulatory approvals. Many of the patients enrolled in the
clinical trials will have previously undergone extensive treatment which
will have substantially weakened the patients and may have irreparably
damaged the ability of their blood and immune system to recover. Some
patients undergoing the transplant recovery process have died, from causes
that were, according to the physicians involved, unrelated to the
AastromReplicell(TM) System procedure, and it is possible that other
patients may die or suffer severe complications during the course of either
the current or future clinical trials. In addition, patients receiving
cells produced with our technologies and product candidates may not
demonstrate long-term engraftment in a manner comparable to cells obtained
from current stem cell therapy procedures. If we cannot demonstrate the
safety or efficacy of our technologies and product candidates, including
long-term sustained engraftment, or if one or more patients die or suffer
severe complications, 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, other
regulatory agencies, and governments in other countries continue to review
and inspect marketed products, manufacturers and manufacturing facilities.
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,
governmental regulatory agencies may establish additional regulations which
could prevent or delay regulatory approval of our products.
4
<PAGE>
Even If We Obtain Regulatory Approvals to Sell Our Products, Lack of
Commercial Acceptance Would Impair Our Business.
Our product development efforts are primarily directed toward
obtaining regulatory approval to market the AastromReplicell(TM) System as
an alternative to, or as an improvement for, the bone marrow harvest and
peripheral blood progenitor cell stem cell collection methods. These stem
cell collection methods have been widely practiced for a number of years,
and our technologies or product candidates may not be accepted by the
marketplace as readily as these or other competing processes and
methodologies. Additionally, our technologies or product candidates may not
be employed in all potential applications being investigated, and any
limited applications would limit the market acceptance of our technologies
and product candidates and our potential revenues. As a result, even if we
obtain all required regulatory approvals, we cannot be certain that our
products and processes will be adopted at a level that would allow us to
operate profitably.
Failure of Third Parties to Manufacture Component Parts or Provide Limited
Source Supplies Would Impair Our New Product Development and Our Sales
Activities.
We rely solely on third parties to manufacture our product candidates
and their component parts. We also rely solely on third party suppliers to
provide necessary key mechanical components, as well as growth factors and
other materials used in the cell expansion process. We would not be able to
obtain alternate sources of supply for many of these items on a short-term
basis. In October 1999, we suspended manufacturing of our products. While
we are in the process of re-establishing our product manufacturing
capabilities, we have not yet completed those activities and resumed
production of certain components of our product line. If any of our key
manufacturers or suppliers fail to perform their respective obligations or
if our supply of growth factors, 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.
Furthermore, some of the compounds used by us in our current stem cell
expansion processes involve the use of animal-derived products. Suppliers
or regulatory authorities may limit or restrict the availability of such
compounds for clinical and commercial use. Any restrictions on these
compounds would impose a potential competitive disadvantage for our
products. If we were not able to develop or obtain alternative compounds,
our product development and commercialization efforts would be harmed.
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.
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 September 30, 2000, we have
incurred net operating losses totaling approximately $80.4 million. These
losses have resulted principally from costs incurred in the research and
development of our cell culture technologies and the AastromReplicell(TM)
System, general and administrative expenses, and the prosecution of patent
applications. We expect to incur significant operating losses until 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, obtaining regulatory approvals, establishing
manufacturing, sales and marketing arrangements with third parties, and
raising sufficient funds to finance our activities. We may not be able to
achieve or sustain profitability.
Our Stock Price Has Been Volatile and Future Sales of Substantial Numbers
of Our Shares Could Have an Adverse Effect on the Market Price of Our
Shares.
The Market price of shares of our common stock has been volatile. The
price of our common stock may continue to fluctuate in response to a number
of events and factors, such as:
. clinical trial results;
. the amount of our cash resources and our ability to obtain
additional funding;
. announcements of research activities, business developments,
technological innovations or new products by us or our
competitors;
. changes in government regulation;
. disputes concerning patents or proprietary rights;
. changes in our revenues or expense levels;
. public concern regarding the safety, efficacy or other
aspects of the products or methodologies we are developing;
and
. changes in potential recommendations by securities analysts.
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 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 shares, regardless of our operating
performance or prospectus. For example, since November, 1999 our stock
price has experienced a day where it closed at approximately twice the
previous day's closing price and another day when it dropped by over 20%
from the previous day's closing price. Additionally, since December 1999
the closing market price of our common stock has ranged from $0.60 to $7.75
per share. Based upon market fluctuations in our stock and depending upon
the timing and amount of shares sold by us, if any, pursuant to this
prospectus, investors who purchase our common stock may experience a
significant decrease in the market price of their shares over a short
period of time.
In addition, sales, or the possibility of sales, of substantial
numbers of shares of common stock in the public market, including sales
pursuant to this prospectus, could adversely affect prevailing market
prices of shares of common stock. Our employees hold a significant number
of options to purchase shares, many of which are presently exercisable.
Employees may exercise their options and sell shares shortly after such
options become exercisable, particularly if they need to raise funds to pay
for the exercise of such options or to satisfy tax liabilities that they
may incur in connection with exercising their options. Additionally,
beginning January 1, 2001, COBE BCT will be able to sell all of its
approximately 2.4 million shares of our common stock without restriction.
5
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Given Our Limited Internal Sales and Marketing Capabilities, We Need to
Develop Collaborative Relationships to Sell, Market and Distribute Our
Products.
While we have commenced initial marketing on a limited basis of the
AastromReplicell(TM) System in Europe, we have only limited internal sales,
marketing and distribution capabilities. We intend to market our products
through collaborative relationships with companies for sales, marketing and
distribution capabilities. If we cannot develop and maintain those
relationships, we would have only a limited ability to market, sell and
distribute our products. Even if we are able to enter into such
relationships, they may not succeed or be sustained on a long-term basis,
and termination would require us to develop alternate arrangements at a
time when we need sales, marketing or distribution capabilities to meet
existing demand. For example, in November 1998 Aastrom and COBE BCT
terminated a strategic alliance for the worldwide distribution of the
AastromReplicell(TM) System for stem cell therapy and related uses. We are
now seeking to enter into other arrangements relating to the development
and marketing of our product candidates.
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. Although the FDA has indicated it intends to
regulate the AastromReplicell(TM) System for stem cell therapy as a Class
III medical device, the FDA may ultimately choose to regulate the
AastromReplicell(TM) System under another category. Because our product
development programs are designed to satisfy the standards applicable to
Class III medical devices, a change in the regulatory classification would
affect our ability to obtain FDA approval of our products. Also, the FDA is
in the process of developing its requirements with respect to somatic cell
therapy and gene cell therapy products. Until the FDA issues definitive
regulations covering our product candidates, the regulatory guidelines or
requirements for approval of such product candidates and/or the cells
produced by them will continue to be uncertain.
If We Do Not Keep Pace With Our Competitors and With Technological and
Market Changes, Our Products May Become Obsolete and Our Business May
Suffer.
The market for our product is very competitive and is subject to rapid
technological changes. Many of our competitors have significantly greater
resources, more product candidates and have developed product 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. In
addition, some recently published studies have suggested that stem cell
therapy, which is the current principal market for our SC-I Therapy Kit,
may have limited clinical benefit in the treatment of breast cancer, which
is a significant portion of the current overall stem cell transplant
market. Our products are designed to improve upon traditional stem cell
collection methods, but even if we are able to demonstrate improved or
equivalent results, practitioners may not switch to our new processes.
Given the experience and expertise associated with traditional methods, if
we cannot develop our cell production procedure to lead to a less expensive
and quicker recovery time than seen with the traditional methods, then we
will suffer a competitive disadvantage. Finally, to the extent that others
develop new technologies that address the diseases and health conditions we
have targeted, our business will suffer.
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, we cannot be
assured that patents will be granted on any of our pending or future patent
applications. We also cannot be assured that the scope of any of our issued
patents will 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. Furthermore, we
rely on licenses granted by the University of Michigan for certain of our
patent rights. If we breach such agreements or otherwise fail to comply
with such agreements, or if such agreements expire or are otherwise
terminated, we may lose our rights under the patents held by the University
of Michigan. We also rely on trade
6
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secrets and unpatentable know-how which 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 management's
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 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 payor's 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 United States 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 available from third-party payors may reduce the demand for,
or negatively affect the price of, our products. For example, recently
published studies have suggested that stem cell transplantation in breast
cancer, which constitutes a significant portion of the overall stem cell
therapy market, may have limited clinical benefit. The market for our
products would be negatively affected by lack of reimbursement for these
procedures by insurance payors.
Potential Product Liability Claims Could Effect Our Earnings and Financial
Condition.
We face an inherent business risk of exposure to product liability
claims in the event that the use of the AastromReplicell(TM) System during
research and development efforts, including clinical trials, or after
commercialization results in adverse effects. 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.
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. In an effort to conserve financial
resources, we have been forced to implement reductions in our work force on
two separate occasions. As a result of these and other factors, we may not
be successful in hiring or retaining key personnel.
Our Outstanding Warrants Have the Potential for Substantial Dilution of
Stockholders.
In June 2000, we issued warrants to purchase up to 3,348,915 shares of
our common stock at $0.01 per share. If all 3,348,915 shares of common
stock are issued under the warrants, then holders of common stock could
experience significant dilution of their investment.
7
<PAGE>
The exercise price of the warrants that we issued in February 2000 is
subject to reduction in the event the price of our common stock goes down
at specified times in the future or if we issue additional securities at
less than the warrant exercise price. If the exercise price of these
warrants is reduced, there would also be an increase in the number of
shares that could be issued upon exercise of the warrants. The warrants are
currently exercisable for 1,382,816 shares of common stock. This number of
shares could increase to 2,614,386 shares of common stock and the exercise
price could be reduced to as low as $1.60 per share. Holders of common
stock could therefore experience dilution of their investment upon exercise
of these warrants.
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, together
with certain provisions of our charter documents, 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.
8
<PAGE>
We May Be Required to Redeem a Portion of Our Shares, Which Would
Significantly Reduce Our Limited Cash Resources.
The original purchasers of the shares and warrants issued in February
2000 and June 2000 may require us to redeem some or all of those shares in
the event that we fail to perform certain administrative activities that
are within our control. These administrative activities include: issuing
the shares of common stock upon the exercise of the warrants, transferring
or instructing the transfer agent to transfer shares of common stock issued
upon exercise of the warrants when required and removing any restrictive
legends from such shares of common stock when required. Such a redemption
could significantly reduce our limited capital resources.
If We Do Not Continue to Meet the Nasdaq Listing Requirements Then Our
Stock May Be Delisted From Nasdaq, Which Could Affect the Market Price and
Liquidity of Our Stock.
We are required to meet certain financial tests (including, but not
limited to, a minimum bid price of our common stock of $1.00 and $4 million
in tangible net worth) to maintain the listing of our common stock on the
Nasdaq National Market. Within the last year, our common stock price has
fallen below the minimum level for some periods and during other periods
our tangible net worth has been below the amount required. During late
December 2000, our stock price has again fallen below $1.00. In the future,
our stock price or tangible net worth may fall below the Nasdaq
requirements, or we may not comply with other listing requirements, with
the result being that our common stock might be delisted. If that happened
the market price and liquidity of our common stock would be impaired.
Absence of Dividends Could Reduce Our Attractiveness to Investors.
Some investors favor companies that pay dividends, particularly in
market downturns. We have never paid cash dividends on our common stock and
do not anticipate paying any cash dividends on our common stock in the
foreseeable future. Therefore, your return on this investment will depend
on your ability to sell our stock at a profit.
Forward-Looking Statements
This prospectus contains certain forward-looking statements within the
meaning of Section 27A of the Securities Act and Section 21E of the
Securities Exchange Act. These forward-looking statements include
statements regarding:
. uncertainties related to potential strategic collaborations
with others;
. future capital needs and uncertainty of additional funding;
. uncertainties related to product development and
marketability;
. uncertainties related to clinical trials;
. manufacturing and supply uncertainties and dependence on
third parties;
. anticipation of future losses;
. limited sales and marketing capabilities;
. uncertainty of regulatory approval and extensive government
regulation;
. competition and technological change;
. uncertainty regarding patents and proprietary rights;
. no assurance of third party reimbursement;
. hazardous materials; and
. potential product liability and availability of insurance.
These statements are subject to risks and uncertainties, including those
set forth in this Risk Factors section, and actual results could differ
materially from those expressed or implied in these statements. All
forward-looking statements included in this prospectus are made as of the
date hereof. We assume no obligation to update any such forward-looking
statement or reason why actual results might differ.
9
<PAGE>
WHERE YOU CAN FIND MORE INFORMATION
We file annual, quarterly and special reports, proxy statements and
other information with the SEC. You may read and copy any document we file
at the SEC's public reference rooms located at Room 1024, 450 Fifth Street,
N.W., Washington, D.C. 20549, at The Citicorp Center, 500 West Madison
Street, Suite 1400, Chicago, Illinois 60661, and at Seven World Trade
Center, Suite 1300, New York, New York 10048. Please call the SEC at 1-800-
SEC-0330 for further information on the public reference rooms. Our filings
with the SEC are also available to the public on the SEC's Internet web
site at http://www.sec.gov.
------------------
The SEC allows us to "incorporate by reference" the information we
file with it, which means that we can disclose important information to you
by referring you to those documents. The information incorporated by
reference is considered to be part of this prospectus, and information that
we file with the SEC later will automatically update and supersede the
information in this prospectus or incorporated by reference. The following
documents filed by us and any future filings made by us with the SEC under
Sections 13(a), 13(c) 14 or 15(d) of the Securities Exchange Act of 1934,
until we sell all of the common stock offered hereby, are incorporated by
reference in this prospectus:
1. Our Annual Report on Form 10-K for the year ended June 30, 2000
(Commission File No.: 000-22025);
2. Our Quarterly Report on Form 10-Q for the quarter ended September
30, 2000 (Commission File No. 000-22025); and
3. Our Registration Statement on Form 8-A filed with the Commission
on April 11, 1997 (Commission File No.: 000-22025).
YOU MAY REQUEST A COPY OF THESE FILINGS, AT NO COST, BY WRITING OR
TELEPHONING US AT AASTROM BIOSCIENCES, INC., 24 FRANK LLOYD WRIGHT DRIVE,
P.O. BOX 376, ANN ARBOR, MICHIGAN 48106, TELEPHONE NUMBER (734) 930-5555,
ATTENTION: CHIEF FINANCIAL OFFICER.
10
<PAGE>
PLAN OF DISTRIBUTION
We may offer our common stock:
- directly to purchasers;
- to or through underwriters;
- through dealers, agents or institutional investors; or
- through a combination of such methods.
Regardless of the method used to sell the securities, we will provide a
prospectus supplement or amendment that will disclose:
- the identity of any underwriters, dealers, agents or investors
who purchase the securities;
- the material terms of the distribution, including the amount sold
and the consideration paid;
- the amount of any compensation, discounts or commissions to be
received by the underwriters, dealers or agents;
- the terms of any indemnification provisions, including
indemnification from liabilities under the federal securities
laws; and
- 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.
We may sell our common stock at fixed prices, which may change, at market
prices prevailing at the time of sale, at prices related to prevailing
market prices or at negotiated prices.
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 which 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 which 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.
11
<PAGE>
USE OF PROCEEDS
We cannot guarantee that we will receive any proceeds in connection
with this offering because we may choose not to issue any shares of common
stock.
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, 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. Additional capital may be raised through additional public or
private financing, as well as collaborative relationships, incurring debt
and other available sources.
LEGAL MATTERS
The validity of the common stock offered hereby will be passed upon
for Aastrom by Pepper Hamilton LLP, Detroit, Michigan acting as special
counsel to Aastrom. Gray Cary Ware & Freidenrich LLP, San Diego,
California, has acted as counsel to Aastrom in connection with this
offering.
EXPERTS
The financial statements incorporated in this prospectus by reference
to the Annual Report on Form 10-K for the year ended June 30, 2000, have
been so incorporated in reliance on the report of PricewaterhouseCoopers
LLP, independent accountants, given on the authority of said firm as
experts in auditing and accounting.
12
<PAGE>
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 14. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION.
Other expenses in connection with the registration of the common stock
hereunder will be substantially as follows (all expenses other than the SEC
Registration Fee are estimates):
Company
Item Expense
---- -------
SEC Registration Fee............. $ 2,130
Printing and engraving expenses $ 5,000
Legal fees and expenses.......... $ 50,000
Accounting fees and expenses..... $ 10,000
Nasdaq Filing Fees............... $ 17,500
Miscellaneous.................... $ 15,370
------------- --------
Total....................... $100,000
===== ========
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 Registrant, provide that the Registrant 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 Registrant 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 Registrant, 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 Registrant or its shareholders. This section also
authorizes the Registrant to advance expenses incurred by any agent of the
Registrant 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 Registrant to purchase and maintain insurance
on behalf of any person who is or was a director, officer, employee or agent of
the Registrant against any liability asserted against or incurred by such person
in such capacity or arising out of such person's status as such, regardless of
whether the Registrant would have the power to indemnify such person against
such liability under the provisions of the MBCA.
The Registrant has entered into an indemnification agreement with certain
of its directors, officers and other key personnel, which contains provisions
that may in some respects be broader than the specific indemnification
provisions contained under applicable law. The indemnification agreement may
require the Registrant, 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
Registrant, 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 Registrant's directors' and
officers' liability insurance policies is maintained.
II-1
<PAGE>
Section 1209 of the MBCA permits a Michigan corporation to include in its
Articles of Incorporation a provision eliminating or limiting a director's
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 violation of the law, or the receipt
of improper personal benefits cannot be eliminated or limited in this manner.
The Registrant's 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.
ITEM 16. EXHIBITS.
EXHIBIT
NUMBER DESCRIPTION OF DOCUMENT
-----------------------
4.1* Restated Articles of Incorporation
4.2* Bylaws, as amended
5.1 Consent and Opinion of Pepper Hamilton LLP
23.1 Consent of PricewaterhouseCoopers LLP
23.2* Consent of Gray Cary Ware & Freidenrich LLP
23.3 Consent of Pepper Hamilton LLP (included in Exhibit 5.1)
24.1* Power of Attorney
* Filed previously.
5. ITEM 17. UNDERTAKING.
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:
(2) To include any prospectus required by section 10(a)(3) of the Securities
Act of 1933 (the "Securities Act");
(3) 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) 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;
(4) 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 paragraphs (a)(1)(i) and (a)(1)(ii) do not apply if
the information required to be included in a post-effective amendment by
those paragraphs is contained in periodic reports filed 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.
(5) That, for the purpose of determining any liability under the Securities
Act, 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.
(6) 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.
II-2
<PAGE>
The undersigned Registrant hereby undertakes that, for purposes of
determining any liability under the Securities Act, each filing of the
Registrant's annual report pursuant to section 13(a) or section 15(d) of the
Securities Exchange Act of 1934 that is incorporated by reference in the
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.
The undersigned Registrant hereby undertakes to deliver or cause to be
delivered with the prospectus, to each person to whom the prospectus is sent or
given, the latest annual report to security holders that is incorporated by
reference in the prospectus and furnished pursuant to and meeting the
requirements of Rule 14a-3 or Rule 14c-3 under the Securities Exchange Act of
1934; and, where interim financial information required to be presented by
Article 3 of Regulation S-X are not set forth in the prospectus, to deliver, or
cause to be delivered to each person to whom the prospectus is sent or given,
the latest quarterly report that is specifically incorporated by reference in
the prospectus to provide such interim financial information.
Insofar as indemnification for liabilities arising under the Securities Act
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 Securities 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 Securities Act and will be governed by
the final adjudication of such issue.
The undersigned Registrant hereby undertakes that:
For the purposes of determining any liability under the Securities Act, the
information omitted from the form of prospectus filed as part of this
registration statement in reliance upon Rule 430A and contained in a form of
prospectus filed by the Registrant pursuant to Rule 424(b)(1) or (4) or 497(h)
under the Securities Act shall be deemed to be part of the registration
statement as of the time it was declared effective.
For the purposes of determining any liability under the Securities Act,
each post-effective amendment that contains a form of prospectus 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.
II-3
<PAGE>
SIGNATURES
Pursuant to the requirements of the Securities Act, the Registrant certifies
that it has reasonable grounds to believe that it meets all of the requirements
of filing on Form S-3 and has duly caused this amended Registration Statement to
be signed on its behalf by the undersigned, thereunto duly authorized in the
City of Ann Arbor, State of Michigan, on December 29, 2000.
AASTROM BIOSCIENCES, INC.
By: /s/ R. Douglas Armstrong, Ph.D.
-------------------------------------
R. Douglas Armstrong, Ph.D.
President and Chief Executive Officer
(Principal Executive Officer)
Pursuant to the requirements of the Securities Act of 1933, this amended
Registration Statement has been signed below by the following persons in the
capacities and on the dates indicated.
<TABLE>
<CAPTION>
Signature Title
--------- -----
Date
----
<S> <C> <C>
/s/ R. Douglas Armstrong, Ph.D. President, Chief Executive Officer and Chairman December 29, 2000
--------------------------------
R. Douglas Armstrong, Ph.D. of the Board of Directors (Principal Executive
Officer)
/s/ Todd E. Simpson Vice President, Finance and Administration, Chief December 29, 2000
--------------------------------
Todd E. Simpson Financial Officer, Secretary and Treasurer
(Principal Financial and Accounting Officer)
* Director December 29, 2000
--------------------------------
Fabrizio Bonanni
* Director December 29, 2000
--------------------------------
Mary L. Campbell
* Director December 29, 2000
--------------------------------
Arthur F. Staubitz
* Director December 29, 2000
--------------------------------
Joseph A. Taylor
* Director December 29, 2000
--------------------------------
Alan M. Wright
</TABLE>
* By: R. Douglas Armstrong
--------------------------
Attorney in Fact
II-4
<PAGE>
INDEX TO EXHIBITS
EXHIBIT
NUMBER DESCRIPTION OF DOCUMENT
-----------------------
4.1* Restated Articles of Incorporation
4.2* Bylaws, as amended
5.1 Consent and Opinion of Pepper Hamilton LLP
23.1 Consent of PricewaterhouseCoopers LLP
23.2* Consent of Gray Cary Ware & Freidenrich LLP
23.3 Consent of Pepper Hamilton LLP (included in Exhibit 5.1)
24.1* Power of Attorney
* Filed previously
II-5
