sv3
As
filed with the Securities and Exchange Commission on February 2, 2007
Registration
No. 333-
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM S-3
REGISTRATION STATEMENT
Under
The Securities Act of 1933
INTROGEN THERAPEUTICS, INC.
(Exact name of Registrant as specified in its charter)
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Delaware
(State or other jurisdiction of
incorporation or organization)
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74-2704230
(I.R.S. Employer
Identification Number) |
301 Congress Avenue, Suite 1850
Austin, Texas 78701
(512) 708-9310
(Address, including zip code, and telephone number, including area code, of Registrants principal executive offices)
David G. Nance
Chief Executive Officer
Introgen Therapeutics, Inc.
301 Congress Avenue, Suite 1850
Austin, Texas 78701
(512) 708-9310
(Name, address, including zip code, and telephone number, including area code, of agent for service)
Copies to:
Paul R. Tobias, Esq.
Wilson Sonsini Goodrich & Rosati,
Professional Corporation
8911 Capital of Texas Highway
Westech 360, Suite 3350
Austin, Texas 78759-7247
(512) 338-5400
Approximate date of commencement of proposed sale to the public: From time to time after the effective date of this Registration Statement.
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 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 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 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
CALCULATION OF REGISTRATION FEE
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Title of Each Class of Securities to be Registered(1) |
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Proposed Maximum Aggregate Offering Price(2) |
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Amount of Registration Fee(2) |
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Common Stock, par value $.001 per share |
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$150,000,000 |
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$16,050 |
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(1) |
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This Registration Statement registers an indeterminate number of shares of common stock that the Registrant may sell from time to time. The aggregate offering price for
all the shares of common stock that the Registrant may sell from time to time pursuant to this Registration Statement will not exceed $150,000,000. |
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The registration fee is calculated pursuant to Rule 457(o) under the Securities Act. Pursuant to Rule 415(a)(6) under the Securities Act, shares of common stock having
an aggregate offering price of $5,685,809.80 from our Registration Statement on Form S-3 (File No. 333-107799) filed August 8, 2003 are included in this Registration
Statement. Pursuant to Rule 415(a)(6) and Rule 457(p) of the Securities Act, $608.38 of the registration fee previously paid by the Registrant in connection with such
earlier registration statement is applied to and offset against the registration fee currently due. |
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, as
amended, or until the Registration Statement shall become effective on such date as the SEC, 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 it is not soliciting an
offer to buy these securities in any jurisdiction where the offer, solicitation or sale is not
permitted.
Subject
to completion, dated February 2, 2007
PROSPECTUS
$150,000,000
Common Stock
By this prospectus, we may offer and sell from time to time up to an aggregate of
$150,000,000 of our common stock in amounts, at prices and on terms determined at the time of
offering. We will provide specific terms of the offerings, including the offering prices, in one
or more supplements to this prospectus. The prospectus supplements may also add, update or change
information contained in this prospectus. We may sell the common stock directly to you or to or
through underwriters, dealers or agents we select. If we use underwriters, dealers or
agents to sell the securities, we will name them and describe their compensation in
supplements to this prospectus.
Our
common stock is traded on the Nasdaq Global Market under the symbol INGN. On February 1, 2007, the last reported sale price of our common stock as quoted on the Nasdaq Global
Market was $5.47 per share.
This prospectus may not be used to offer and sell securities unless accompanied by a
prospectus supplement.
You are urged to carefully read this prospectus, the prospectus supplement relating to
any specific offering of common stock and all of the information incorporated by reference herein
and therein. Our business, and an investment in our common stock, involves significant risks.
These risks are discussed in this prospectus under Risk Factors beginning on page 3 and in the
documents incorporated by reference into this prospectus.
Neither the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or passed upon the adequacy or accuracy of this
prospectus. Any representation to the contrary is a criminal offense.
The date of this prospectus is , 2007.
TABLE OF CONTENTS
We have not authorized any person to give any information or make any representations in
connection with this offering other than those contained or incorporated by reference into this
prospectus and any accompanying prospectus supplement in connection with the offering described
herein and therein, and, if given or made, such information or representations must not be relied
upon as having been authorized by us. You should rely only on the information contained in or
incorporated by reference into this prospectus or any applicable prospectus supplement. Neither
this prospectus nor any prospectus supplement shall constitute an offer to sell or a solicitation
of an offer to buy offered securities in any jurisdiction in which it is unlawful for such person
to make such an offering or solicitation. Neither the delivery of this prospectus or any
prospectus supplement nor any sale made hereunder shall under any circumstances imply that the
information contained or incorporated by reference herein or in any prospectus supplement is
correct as of any date subsequent to the date hereof or of such prospectus supplement.
ABOUT THIS PROSPECTUS
This prospectus is part of a registration statement (Registration Statement) that we filed
with the Securities and Exchange Commission (SEC) using a shelf registration process. Under this
shelf process, we may from time to time sell the securities described in this prospectus in one or
more offerings up to a maximum aggregate offering price of $150,000,000. This prospectus provides
you with a general description of the securities we may offer. Each time we offer securities, we
will provide a prospectus supplement that will contain specific information about the terms of that
offering. The prospectus supplement may also add, update or change information contained in this
prospectus.
This prospectus does not contain all of the information included in the Registration
Statement. For a more complete understanding of the offering of the securities, you should refer
to the Registration Statement, including its exhibits. You should read both this prospectus and
any prospectus supplement carefully, including the risks of investing in our common stock discussed
under Risk Factors, together with the additional information described under the heading Where
You Can Find More Information.
Unless otherwise indicated in this prospectus or any prospectus supplement, or the context
otherwise requires, all references to Introgen, the Company, the Registrant, we, us or
our mean Introgen Therapeutics, Inc.
SUMMARY
Overview
Introgen Therapeutics, Inc. was incorporated in Delaware in 1993. We are a biopharmaceutical
company focused on the discovery, development and commercialization of targeted molecular therapies
for the treatment of cancer and other diseases. We are developing product candidates to treat a
wide range of cancers using tumor suppressors, cytokines and other targeted molecular therapies.
These agents are designed to increase production of normal cancer-fighting proteins that act to
overpower cancerous cells, stimulate immune activity and enhance conventional cancer therapies.
Our primary approach to the treatment of cancers is to deliver targeted molecular therapies
that increase production of normal cancer-fighting proteins to induce apoptosis, cell cycle
control, cell growth control and gene regulation, including the regulation of angiogenic and immune
factors. Our products work by acting as templates for the transient in vivo production of proteins
that have pharmacological properties. The resultant proteins engage disease-related molecular
targets or receptors to produce specific therapeutic effects.
We believe the use of targeted molecular therapies to induce the production of
biopharmaceutical proteins represents a new approach for treating many cancers while avoiding the
toxic side effects common to traditional therapies. We have developed significant expertise in
developing targeted therapies that may be used to treat disease and in using what we believe are
safe and effective delivery systems to transport these agents to the cancer cells. We believe we
are able to treat a number of cancers in a way that kills cancer cells without harming normal
cells.
Our principal executive offices are located at 301 Congress Avenue, Suite 1850, Austin, Texas
78701 and our telephone number is (512) 708-9310. Our website is located at www.introgen.com. The
information contained on our website is not a part of this prospectus.
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The Offering
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Securities offered by Introgen
Therapeutics, Inc.:
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Up to $150,000,000 of common stock
in one or more offerings. A
prospectus supplement, which we will
provide each time we offer common
stock, will describe the specific
amounts, prices and terms of the
common stock. |
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We may sell the common stock to or
through underwriters, dealers or
agents or directly to purchasers.
We, as well as any agents acting on
our behalf, reserve the sole right
to accept and to reject in whole or
in part any proposed purchase of
common stock. Each prospectus
supplement will set forth the names
of any underwriter, dealer or agent
involved in the sale of common stock
described in that prospectus
supplement and any applicable fees,
commissions or discount arrangements
with them. |
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Use of proceeds:
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Unless otherwise indicated in any
prospectus supplement, the net
proceeds from the sale of common
stock offered by this prospectus
will be used for general corporate
purposes and working capital
requirements. We may also use a
portion of the net proceeds to fund
possible investments in and
acquisitions of complementary
businesses, partnerships, minority
investments, products or
technologies. Currently, there are
no commitments or agreements
regarding such acquisitions or
investments that are material.
Pending their ultimate use, we
intend to invest the net proceeds in
money market funds, commercial paper
and governmental and
non-governmental debt securities
with maturities of up to five years. |
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Risk factors:
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See Risk Factors for a discussion
of the factors you should carefully
consider before deciding to invest
in shares of our common stock. |
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RISK FACTORS
An investment in our common stock involves a high degree of risk. In addition to the other
information contained in this prospectus, you should carefully consider the following risks and
uncertainties before purchasing our common stock. Our business, financial condition and operating
results could be materially adversely affected by these risks and uncertainties. In that case, the
trading price of our common stock could decline and you could lose all or part of your investment.
The risks and uncertainties described below are not the only ones we face. Additional risks and
uncertainties may also impair our business operations.
If we are unable to commercialize ADVEXIN® therapy in various markets for multiple
indications, particularly for the treatment of recurrent head and neck cancer, our business will be
harmed.
Our ability to achieve and sustain operating profitability depends on our ability to
successfully commercialize ADVEXIN therapy in various markets for multiple indications, which
depends in large part on our ability to commence, execute and complete clinical programs and obtain
regulatory approvals for ADVEXIN therapy and other drug candidates. In particular, our ability to
achieve and sustain profitability will depend in large part on our ability to commercialize ADVEXIN
therapy for the treatment of recurrent head and neck cancer in the United States. We cannot assure
you we will receive approval for ADVEXIN therapy for the treatment of recurrent head and neck
cancer or other types of cancer or indications in the United States or in other countries or if
approved that we will achieve significant level of sales. If we are unable to do so, our business
will be harmed.
If we fail to comply with FDA or foreign regulatory authority requirements or encounter delays
or difficulties in clinical trials for our product candidates, we may not obtain regulatory
approval of some or all of our product candidates on a timely basis, if at all.
In order to commercialize our product candidates, we must obtain certain regulatory approvals.
Satisfaction of regulatory requirements typically takes many years, and involves compliance with
requirements covering research and development, testing, manufacturing, quality control, labeling
and promotion of drugs for human use. To obtain regulatory approvals, we must, among other
requirements, complete clinical trials demonstrating our product candidates are safe and effective
for a particular cancer type or other disease. Regulatory approval of a new drug is never
guaranteed. The FDA and foreign regulatory authorities have substantial discretion in the approval
process. Despite the time and experience exerted, failure can occur at any stage, and we could
encounter problems causing us to abandon clinical trials.
We have completed or are conducting clinical trials of our lead product candidate, ADVEXIN
therapy, for the treatment of various cancers. Current or future clinical trials may demonstrate
ADVEXIN therapy is neither safe nor effective.
We have completed or are conducting clinical trials of INGN 241, a product candidate based on
the mda-7 tumor suppressor. We will need to continue conducting significant research and animal
testing, referred to as pre-clinical testing, to support performing clinical trials for our other
product candidates. It will take us many years to complete pre-clinical testing and clinical
trials, and failure could occur at any stage of testing. Current or future clinical trials may
demonstrate INGN 241 or our other product candidates are neither safe nor effective.
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Any delays or difficulties we encounter in our pre-clinical research and clinical trials may
delay or preclude regulatory approval. Our product development costs will increase if we experience
delays in testing or regulatory approvals or if we need to perform more or larger clinical trials
than planned. Any delay or preclusion could also delay or preclude the commercialization of ADVEXIN
therapy or any other product candidates. In addition, we, the FDA or foreign regulatory authorities
might delay or halt any of our clinical trials of a product candidate at any time for various
reasons, including:
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the product candidate is less effective and/or more toxic than current
therapies; |
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the presence of unforeseen adverse side effects of a product candidate,
including its delivery system; |
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a longer than expected time required to determine whether or not a product
candidate is effective; |
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the death of patients during a clinical trial, even if the product candidate
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the failure to enroll a sufficient number of patients in our clinical trials; |
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the inability to produce sufficient quantities of a product candidate to complete the trials; or |
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the inability to commit the necessary resources to fund the clinical trials. |
We cannot be certain the results we observed in our pre-clinical testing will be confirmed in
clinical trials or the results of any of our clinical trials will support FDA or other regulatory
approval. Pre-clinical and clinical data can be interpreted in many different ways, and FDA or
foreign regulatory officials could interpret differently data we consider promising, which could
halt or delay our clinical trials or prevent regulatory approval.
Despite the FDAs designation of ADVEXIN therapy as a Fast Track product, we may encounter
delays in the regulatory approval process due to additional information requirements from the FDA,
unintentional omissions in our BLA for ADVEXIN therapy, or other delays in the FDAs review
process. Similarly, although we have an agreement with the EMEA to file for marketing approval for
ADVEXIN therapy under the EMEAs Exceptional Circumstances provisions, we may encounter delays in
the regulatory approval process due to additional information requirements from the EMEA,
unintentional omissions in our Marketing Authorization Application filed with the EMEA, or other
delays in the EMEAs review process. We may encounter delays or rejections in the regulatory
approval process because of additional government regulation from future legislation or
administrative action or changes in FDA or EMEA policy during the period of product development,
clinical trials and FDA and EMEA regulatory review.
Despite the initiation of the BLA process for ADVEXIN therapy under the FDAs accelerated
approval regulations, the FDA could determine that accelerated approval is not warranted and that a
traditional BLA filing must be made. Such a determination could delay regulatory approval.
Additionally, accelerated approval of an application could be subject to Phase 4 or post-approval
studies to validate the surrogate endpoint or confirm the effect on the clinical endpoint. Failure
to validate a surrogate endpoint or confirm a clinical benefit during post-marketing studies could
cause the product to be withdrawn from the market by the FDA on an expedited basis.
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Even if our products are approved by regulatory authorities, if we fail to comply with ongoing
regulatory requirements, or if we experience unanticipated problems with our products, these
products could be subject to restrictions or withdrawal from the market.
Any product for which we obtain marketing approval, along with the manufacturing processes,
post-approval clinical data and promotional activities for such product, will be subject to
continual review and periodic inspections by the FDA and other regulatory bodies. Even if
regulatory approval of a product is granted, the approval may be subject to limitations on the
indicated uses for which the product may be marketed or certain requirements for costly
post-marketing testing and surveillance to monitor the safety or efficacy of the product. Later
discovery of previously unknown problems with our products, including unanticipated adverse events
of unanticipated severity or frequency, manufacturer or manufacturing processes or failure to
comply with regulatory requirements, may result in restrictions on such products or manufacturing
processes, withdrawal of the products from the market, voluntary or mandatory recall, fines,
suspension of regulatory approvals, product seizures or detention, injunctions or the imposition of
civil or criminal penalties.
Failure to comply with foreign regulatory requirements governing human clinical trials and
marketing approval for drugs could prevent us from selling our products in foreign markets, which
may adversely affect our operating results and financial conditions.
For marketing drugs and biologics outside the United States, the requirements governing the
conduct of clinical trials, product licensing, pricing and reimbursement vary greatly from country
to country and may require additional testing. The time required to obtain approvals outside the
United States may differ from that required to obtain FDA approval. We may not obtain foreign
regulatory approval on a timely basis, if at all. Approval by the FDA does not ensure approval by
regulatory authorities in other countries, and approval by one foreign regulatory authority does
not ensure approval by regulatory authorities in other countries or by the FDA. Failure to comply
with these regulatory requirements or to obtain required approvals could impair our ability to
develop these markets and could have a material adverse effect on our results of operations and
financial condition.
We have a history of operating losses, expect to incur significant additional operating losses
and may never become profitable.
We have generated operating losses since we began operations in June 1993. As of September 30,
2006, we had an accumulated deficit of approximately $165.1 million. We expect to incur substantial
additional operating expense and losses over the next several years as our research, development,
pre-clinical testing and clinical trial activities increase. As we expand our operations and
develop systems to support commercialization of our product candidates, these losses, among other
things, have had, and are expected to continue to have, an adverse impact on our total assets,
stockholders equity and working capital.
We have no products that have generated any commercial revenue. Presently, we earn minimal
revenue from contract services activities, grants, interest income and rent from the lease of a
portion of our facilities to M. D. Anderson Cancer Center. We do not expect to generate revenue
from the commercial sale of products in the near future, and we may never generate revenue from the
commercial sale of products.
If we continue to incur operating losses for a period longer than we anticipate and fail to
obtain the capital necessary to fund our operations, we will be unable to advance our development
program and complete our clinical trials.
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Developing a new drug and conducting clinical trials is expensive. Our product development
efforts may not lead to commercial products, either because our product candidates fail to be found
safe or effective in clinical trials or because we lack the necessary financial or other resources
or relationships to pursue our programs through commercialization. Our capital and future revenue
may not be sufficient to support the expense of our operations, the development of commercial
infrastructure and the conduct of our clinical trials and pre-clinical research.
We expect we will fund our operations over approximately the next 21 to 24 months with our
current working capital, which we accumulated primarily from sale of equity securities, income from
contract services and research grants, debt financing of equipment acquisitions, the lease of a
portion of our facilities to M. D. Anderson Cancer Center and interest on invested funds. We intend
to raise additional capital sooner, however, under various circumstances, including if we
experience:
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an acceleration of the number, size or complexity of our clinical trials; |
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slower than expected progress in developing ADVEXIN therapy, INGN 241 or other
product candidates; |
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higher than expected costs to obtain regulatory approvals; |
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higher than expected costs to pursue our intellectual property strategy; |
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higher than expected costs to further develop and scale up our manufacturing capability; |
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higher than expected costs to develop our sales and marketing capability; |
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faster than expected rate of progress and cost of our research and development
and clinical trial activities; |
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a decrease in the amount and timing of milestone payments we receive from
collaborators; |
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higher than expected costs of preparing an application for FDA or foreign
regulatory approval of ADVEXIN therapy; |
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higher than expected costs of developing the processes and systems to support
FDA or foreign regulatory approval of ADVEXIN therapy; |
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an increase in our timetable and costs for the development of marketing
operations and other activities related to the commercialization of ADVEXIN therapy and
our other product candidates; |
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a change in the degree of success in our Phase 3 clinical trial of ADVEXIN
therapy and in the clinical trials of our other products; |
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the emergence of competing technologies and other adverse market developments; or |
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changes in or terminations of our existing collaboration and licensing arrangements. |
We do not know whether additional financing will be available when needed or on terms
favorable to us or our stockholders. We may need to raise any necessary funds through public or
private equity offerings, debt financings or additional corporate collaboration and licensing
arrangements. To the extent we raise additional capital by issuing equity securities, our
stockholders will experience dilution. If
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we raise funds through debt financings, we may become subject to restrictive covenants. To the
extent we raise additional funds through collaboration and licensing arrangements, we may be
required to relinquish some rights to our technologies or product candidates, or grant licenses on
terms not favorable to us. If we are not able to raise additional funds, we may have to delay,
reduce or eliminate our clinical trials and our development programs.
If we cannot maintain our existing corporate and academic arrangements and enter into new
arrangements, we may be unable to develop products effectively, or at all.
Our strategy for the research, development and commercialization of our product candidates may
result in our entering into contractual arrangements with corporate collaborators, academic
institutions and others. We have entered into sponsored research, license and/or collaborative
arrangements with several entities, including M. D. Anderson Cancer Center, the NCI, Chiba
University in Japan, VirRx and Corixa, which was acquired by GlaxoSmithKline, as well as numerous
other institutions that conduct clinical trials work or perform pre-clinical research for us. Our
success depends upon our collaborative partners performing their responsibilities under these
arrangements and complying with the regulations and requirements governing clinical trials. We
cannot control the amount and timing of resources our collaborative partners devote to our research
and testing programs or product candidates, or their compliance with regulatory requirements which
can vary because of factors unrelated to such programs or product candidates. These relationships
may in some cases be terminated at the discretion of our collaborative partners with only limited
notice to us. We may not be able to maintain our existing arrangements, enter into new arrangements
or negotiate current or new arrangements on acceptable terms, if at all. Some of our collaborative
partners may also be researching competing technologies independently from us to treat the diseases
targeted by our collaborative programs.
If we do not continue to receive grant funding from federal agencies and others, we may be
unable to continue our research and development programs for certain of our product candidates at
current levels or in the manner we have planned for the future.
We rely on grants from third parties, generally federal agencies, to provide the funding
necessary to conduct our research and development programs for some of our technologies and product
candidates. Funding of these grants is typically subject to government appropriations. These grants
often contain provisions that allow for termination at the convenience of the government. Further,
these grants are subject to complex federal guidelines and regulations. If federal agencies or
regulatory authorities determine that we, or the programs for which we desire to receive or have
received grant funding, do not qualify for funding, our scientific or product development programs
could be slowed or stopped and we may suffer financial losses and be unable to successfully
commercialize our products.
If we are not able to create effective collaborative marketing relationships, we may be unable
to market ADVEXIN therapy successfully or in a cost-effective manner.
To effectively market our products, we will need to develop sales, marketing and distribution
capabilities. In order to develop or otherwise obtain these capabilities, we may have to enter into
marketing, distribution or other similar arrangements with third parties in order to sell, market
and distribute our products successfully. To the extent we enter into any such arrangements with
third parties, our product revenue is likely to be lower than if we directly marketed and sold our
products, and any revenue we receive will depend upon the efforts of such third parties. We have no
experience in marketing or selling pharmaceutical products and we currently have no sales,
marketing or distribution capability. We may be unable to develop sufficient sales, marketing and
distribution capabilities to commercialize our products successfully.
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Serious and unexpected side effects attributable to molecular therapies may result in
governmental authorities imposing additional regulatory requirements or a negative public
perception of our products.
ADVEXIN therapy and most of our other product candidates under development could be broadly
described as targeted molecular therapies or recombinant DNA therapies. A number of clinical trials
are being conducted by other pharmaceutical companies involving related therapies, including
compounds similar to, or competitive with, our product candidates. The announcement of adverse
results from these clinical trials, such as serious unwanted and unexpected side effects
attributable to treatment, or any response by the FDA or foreign regulatory authorities to such
clinical trials, may impede the timing of our clinical trials, delay or prevent us from obtaining
regulatory approval or negatively influence public perception of our product candidates, which
could harm our business and results of operations and depress the value of our stock.
The United States Senate has held hearings concerning the adequacy of regulatory oversight of
recombinant DNA therapy clinical trials, as well as the adequacy of research subject education and
protection in clinical research in general, and to determine whether additional legislation is
required to protect volunteers and patients who participate in such clinical trials. The
Recombinant DNA Advisory Committee, which acts as an advisory body to the NIH, has expanded its
public role in evaluating important public and ethical issues in recombinant DNA therapy clinical
trials. Implementation of any additional review and reporting procedures or other additional
regulatory measures could increase the costs of or prolong our product development efforts or
clinical trials.
We report to the FDA and other regulatory agencies serious adverse events, including those we
believe may be reasonably related to the treatments administered in our clinical trials. Such
serious adverse events, whether treatment-related or not, could result in negative public
perception of our treatments and require additional regulatory review or measures, which could
increase the cost of or prolong our clinical trials.
The FDA has not approved any recombinant DNA therapy products of the types being developed by
us for sale in the United States. The commercial success of our products will depend in part on
public acceptance of the use of these types of recombinant DNA products, which are a new type of
disease treatment for the prevention or treatment of human diseases. Public attitudes may be
influenced by claims that these types of recombinant DNA products are unsafe, and these treatment
methodologies may not gain the acceptance of the public or the medical community. Negative public
reaction to these types of recombinant DNA products could also result in greater government
regulation and stricter clinical trial oversight.
Patient enrollment may be slow and patients may discontinue their participation in clinical
studies, which may negatively impact the results of these studies, and extend the timeline for
completion of our and our collaborators development programs for our product candidates.
The time required to complete clinical trails is dependent upon, among other factors, the rate
of patient enrollment. Patient enrollment is a function of many factors, including:
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the size of the patient population; |
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the nature of the clinical protocol requirements; |
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the diversion of patients to other trials or marketed therapies;
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the ability to recruit and manage clinical centers and associated trials; |
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the proximity of patients to clinical sites; and |
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the patient eligibility criteria for the study. |
We are subject to the risk that patients enrolled in our and our collaborators clinical
studies for our product candidates may discontinue their participation at any time during the study
as a result of a number of factors, including, withdrawing their consent or experiencing adverse
clinical events which may or may not be related to our product candidates under evaluation. We are
subject to the risk that if a large number of patients in any one of our studies discontinue their
participation in the study, the results from that study may not be positive or may not support an
NDA for regulatory approval of our product candidates.
We cannot predict the safety profile of the use of ADVEXIN therapy when used in combination
with other therapies.
Many of our trials involve the use of ADVEXIN therapy in combination with other drugs or
therapies. While the data we have evaluated to date suggest ADVEXIN therapy does not increase the
adverse effects of other therapies, we cannot predict if this outcome will continue to be true or
whether possible adverse side effects not directly attributable to the other drugs will compromise
the safety profile of ADVEXIN therapy when used in certain combination therapies.
If we fail to adequately protect our intellectual property rights, our competitors may be able
to take advantage of our research and development efforts to develop competing drugs.
Our commercial success will depend in part on obtaining patent protection for our products and
other technologies and successfully defending these patents against third-party challenges. Our
patent position, like that of other biotechnology and pharmaceutical companies, is highly
uncertain. One uncertainty is the United States Patent and Trademark Office, or PTO, or the courts,
may deny or significantly narrow claims made under patents issued to us or patent applications we
file. This is particularly true for patent applications or patents that concern biotechnology and
pharmaceutical technologies, such as ours, since the PTO and the courts often consider these
technologies to involve unpredictable sciences. Another uncertainty is any patents that may be
issued or licensed to us may not provide any competitive advantage to us because they may not
effectively preclude others from developing and marketing products like ours. Also, our patents may
be successfully challenged, invalidated or circumvented in the future. In addition, our
competitors, many of which have substantial resources and have made significant investments in
competing technologies, may seek to apply for and obtain patents that will prevent, limit or
interfere with our ability to make, use and sell our potential products either in the United States
or in international markets.
Our ability to develop and protect a competitive position based on our biotechnological
innovations, innovations involving molecular therapies, recombinant DNA therapeutic agents, viruses
for delivering targeted molecular therapies to cells, formulations, delivery systems not involving
viruses, and the like, is particularly uncertain. Due to the unpredictability of the
biotechnological sciences, the PTO, as well as patent offices in other jurisdictions, has often
required patent applications concerning biotechnology-related inventions to be limited or narrowed
substantially to cover only the specific innovations exemplified in the patent application, thereby
limiting their scope of protection against competitive challenges. Similarly, courts have
invalidated or significantly narrowed many key patents in the biotechnology industry. Thus, even if
we are able to obtain patents covering commercially significant innovations, our patents may not be
upheld or our patents may be substantially narrowed.
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Through our exclusive license from The University of Texas System for technology developed at
M. D. Anderson Cancer Center, we have obtained and are currently seeking further patent protection
for adenoviral p53, including ADVEXIN therapy, and its use in cancer therapy. Further, the PTO
issued us United States patents for our adenovirus production technology and our purified
adenoviral compositions. We also control, through licensing arrangements, United States patents for
combination therapy involving the p53 tumor suppressor and conventional chemotherapy or radiation,
the use of adenoviral p53 in cancer therapy, adenoviral p53 as a product, the core DNA of
adenoviral p53, pharmaceutical compositions of adenoviral p53 and clinical applications of such
pharmaceutical compositions, as well as patents covering our mda-7 technology. Our competitors may
challenge the validity of one or more of our patents in the courts or through an administrative
procedure known as an interference, in which the PTO determines the priority of invention where two
or more parties are claiming the same invention. The courts or the PTO may not uphold the validity
of our patents, we may not prevail in such interference proceedings regarding our patents and none
of our patents may give us a competitive advantage. In this regard, we have been notified by the
PTO that an unidentified third party is attempting to provoke an interference with one of our
patents directed to adenoviral p53 therapy. We do not at present know the identity of this party
and cannot assess the likelihood of an interference actually being declared. Should that party
prevail in an interference proceeding, a patent may issue to that party that is infringed by, and
therefore potentially preclude our commercialization of, products like ADVEXIN therapy that are
used for adenoviral p53 therapy.
Schering-Plough filed with the European Patent Office, or EPO, an opposition against our
European patent directed to combination therapy with p53 and conventional chemotherapy and/or
radiation. An opposition is an administrative proceeding instituted by a third party and conducted
by the EPO to determine whether a patent should be maintained or revoked, in part or in whole,
based on evidence brought forth by the party opposing the patent. In February 2006, the Technical
Board of Appeals of the EPO held a final oral proceeding concerning Schering-Ploughs opposition
and determined our patent should be maintained as amended. No further appeal by Schering-Plough is
possible.
We rely on trade secrets law to protect technology where we believe patent protection is not
appropriate or obtainable. However, trade secrets are difficult to protect. In addition, we
generally require employees, academic collaborators and consultants to enter into confidentiality
agreements. Despite these measures, we may not be able to adequately protect our trade secrets or
other proprietary information. We are a party to various license agreements that give us rights to
use specified technologies in our research and development processes. If we are not able to
continue to license this technology on commercially reasonable terms, our product development and
research may be delayed. In addition, in the case of technologies that we have licensed, we do not
have the ability to make the final decisions on how the patent application process is managed, and
accordingly are unable to exercise the same degree of control over this intellectual property as we
exercise over our internally developed technology. Our research collaborators and scientific
advisors have rights to publish data and information in which we have rights. If we cannot maintain
the confidentiality of our technology and other confidential information in connection with our
collaborations, then our ability to receive patent protection or protect our proprietary
information will be diminished.
Third-party claims of infringement of intellectual property could require us to spend time and
money to address the claims and could limit our intellectual property rights.
The biotechnology and pharmaceutical industry has been characterized by extensive litigation
regarding patents and other intellectual property rights, and companies have employed intellectual
property litigation to gain a competitive advantage. We are aware of a number of issued patents and
patent applications related to recombinant DNA therapy, the treatment of cancer and the use of the
p53 and other tumor suppressors. Schering-Plough, including its subsidiary Canji, controls various
United
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States applications and a European patent and applications, some of which are directed to
therapy using p53, and others to adenoviruses containing p53, or adenoviral p53, and to methods for
carrying out therapy using adenoviral p53. Adenoviral p53 technology underlies our ADVEXIN therapy
product candidate. Furthermore, we are aware of a United States patent directed to
replication-deficient recombinant adenoviral vectors apparently controlled by Transgene SA
(Transgene). While we believe the claims of the Transgene adenoviral vector patent are invalid or
not infringed by our products, Transgene could assert a claim against us.
One of the foregoing patent applications directed to p53 therapy, which we understand is owned
by The Johns Hopkins University (Johns Hopkins) and controlled by Schering-Plough, was involved in
a PTO interference proceeding with a patent owned by Canji. This Johns Hopkins application was the
United States counterpart to the European patent recently revoked in its entirety by the EPO (see
below). Priority of invention in that interference was awarded by the PTO to the Johns Hopkins
inventors, leading to the issuance of a United States patent, and the Canji patent has been found
unpatentable. While it is our belief that the claims of the Johns Hopkins patent are invalid and
not infringed by our ADVEXIN therapy, Schering-Plough or Johns Hopkins may assert that our ADVEXIN
therapy, which uses p53 therapy, infringes the claims of such patent. While we believe we would
have both an invalidity and non-infringement defense against such an assertion, in the United
States an issued patent enjoys a presumption of validity, which can be overcome only through clear
and convincing evidence. We cannot assure such a defense would prevail.
We may also become subject to infringement claims or litigation arising out of other patents
and pending applications of our competitors, if they issue, or additional interference proceedings
declared by the PTO to determine the priority of inventions. The defense and prosecution of
intellectual property suits, PTO interference proceedings and related legal and administrative
proceedings are costly and time-consuming to pursue, and their outcome is uncertain. Litigation may
be necessary to enforce our issued patents, to protect our trade secrets and know-how or to
determine the enforceability, scope and validity of the proprietary rights of others. An adverse
determination in litigation or interference proceedings to which we may become a party could
subject us to significant liabilities, require us to obtain licenses from third parties, or
restrict or prevent us from selling our products in certain markets. Although patent and
intellectual property disputes are often settled through licensing or similar arrangements, costs
associated with such arrangements may be substantial and could include ongoing royalties.
Furthermore, the necessary licenses may not be available to us on satisfactory terms, if at all. In
particular, if we were found to infringe a valid claim of the Transgene adenoviral vector United
States patent, the Johns Hopkins patent or a patent that may issue from a currently pending
application, our business could be materially harmed.
We have recently been involved in patent opposition proceedings before the EPO, in which we
have sought to have the EPO revoke three different European patents owned or controlled by
Canji/Schering-Plough. These European patents relate to the use of p53, or the use of tumor
suppressors, in the preparation of therapeutic products. In one opposition involving a Canji
European patent directed to the use of a recombinant tumor suppressor, the EPO revoked the European
patent in its entirety in a final, non-appealable decision. In the second opposition, involving a
patent that is directed to therapeutic and other applications of the p53 and that is owned by Johns
Hopkins and, we understand, controlled by Schering-Plough, the EPO recently revoked the patent in
its entirety. The patent owner appealed this decision and the final hearing before the EPO
Technical Board of Appeals was held in June 2005, at which time the Technical Board of Appeals
confirmed the final revocation of all claims of this patent relevant to clinical therapeutic
applications of p53. In a third case involving the use of p53, the European patent at issue was
initially upheld, but finally revoked in a hearing held in late April 2004.
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We may be subject to litigation and infringement claims that may be costly, divert
managements attention, and materially harm our business.
Extensive litigation regarding patents and other intellectual property rights has been common
in the biopharmaceutical industry. Litigation may be necessary to assert infringement claims,
enforce patent rights, protect trade secrets or know-how and determine the enforceability, scope
and validity of certain proprietary rights. The defense and prosecution of intellectual property
lawsuits, PTO interference proceedings, and related legal and administrative proceedings in the
United States and internationally involve complex legal and factual questions. As a result, such
proceedings are costly and time-consuming to pursue and their outcome is uncertain.
Regardless of merit or outcome, our involvement in any litigation, interference or other
administrative proceedings could cause us to incur substantial expense and could significantly
divert the efforts of our technical and management personnel. An adverse determination may subject
us to the loss of our proprietary position or to significant liabilities, or require us to seek
licenses that may include substantial cost and ongoing royalties. Licenses may not be available
from third parties, or may not be obtainable on satisfactory terms. An adverse determination or a
failure to obtain necessary licenses may restrict or prevent us from manufacturing and selling our
products, if any. These outcomes could materially harm our business, financial condition and
results of operations.
If we fail to meet our obligations under license agreements, we may lose our rights to key
technologies on which our business depends.
Our business depends in part on patents licensed from third parties. Those third-party license
agreements impose obligations on us, such as payment obligations and obligations to diligently
pursue development of commercial products under the licensed patents. If a licensor believes we
have failed to meet our obligations under a license agreement, the licensor could seek to limit or
terminate our license rights, which could lead to costly and time-consuming litigation and,
potentially, a loss of the licensed rights. During the period of any such litigation, our ability
to carry out the development and commercialization of product candidates could be significantly and
negatively affected. If our license rights were restricted or ultimately lost, our ability to
continue our business based on the affected technology platform would be severely adversely
affected.
Competition and technological change may make our product candidates and technologies less
attractive or obsolete.
We compete with pharmaceutical and biotechnology companies, including Canji and Genvec, which
are pursuing forms of treatment similar to ours for the diseases ADVEXIN therapy and our other
product candidates target. We are aware that Canji, with its parent Schering-Plough, has in the
past been involved in research and/or development of adenoviral p53 products and has numerous
patents and patent applications relating to adenoviral p53 therapy. We understand Schering-Plough
has stopped its adenoviral p53 clinical trials, and it is unknown whether these parties are
continuing their adenoviral p53 research and/or development efforts. We are also aware that a
Chinese pharmaceutical company, SiBiono GeneTech, has recently announced it has received regulatory
approval from the Chinese drug regulatory agency to market an adenoviral p53 product only in China.
We control an issued Chinese patent covering adenoviral p53, and a number of pending Chinese
applications directed to p53 therapy and adenoviral production. We understand enforcement of
patents in China is unpredictable and we do not know if monetary damages could be recovered from
SiBiono GeneTech if its product infringes our patent or patent applications. Patent enforcement and
respect of international patent standards, rules and laws have not historically been a key
characteristic of the Chinese government and patent system. Further, geopolitical developments,
including trade and tariff disputes between the government of China and the
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United States Department of Commerce could add additional uncertainty to any effort to enforce
patents, recover damages, if any, or engage in the sales and marketing of patented or non-patented
products in China. We are aware that ImClone and Bristol Myers Squibb have obtained marketing
approval for a monoclonal antibody product (Erbitux) for the treatment of certain kinds of
recurrent head and neck cancer. We also may face competition from companies that may develop
internally or acquire competing technology from universities and other research institutions. As
these companies develop or acquire their technologies, they may develop competitive positions that
may prevent or limit our product commercialization efforts.
Some of our competitors are established companies with greater financial and other resources
than ours. Other companies may succeed in developing products earlier than we do, obtaining FDA or
foreign regulatory authority approval for products before we do or developing products that are
more effective than our product candidates. While we will seek to expand our technological
capabilities to remain competitive, research and development by others may render our technology or
product candidates obsolete or non-competitive or result in treatments or cures superior to any
therapy developed by us.
Even if we receive regulatory approval to market our ADVEXIN therapy, INGN 241, INGN 225 or
other product candidates, we may not be able to commercialize them profitably.
Our profitability will depend on the markets acceptance of ADVEXIN therapy, INGN 241, INGN
225, if approved, and our other product candidates. The commercial success of our product
candidates will depend on whether:
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they are more effective than alternative treatments; |
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their side effects are acceptable to patients and doctors; |
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insurers and other third-party healthcare payers will provide adequate
reimbursement for them; |
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we produce and sell them at a profit; and |
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we market ADVEXIN therapy, INGN 241, INGN 225 and other product candidates
effectively. |
We must achieve significant market share and obtain high per-patient prices for our products
to achieve profitability.
ADVEXIN therapy, our lead product candidate will, if approved, initially be targeted for the
treatment of recurrent head and neck cancer, a disease with an annual incidence of approximately
40,000 patients in the United States. As a result, our per-patient prices must be sufficiently high
in order to recover our development costs and achieve profitability. Until additional disease
targets with larger potential markets are approved, we believe we will need to market worldwide to
achieve significant market penetration. If we are unable to obtain sufficient market share for our
drug products at a high enough price, or obtain expanded approvals for larger markets, we may not
achieve profitability or be able to independently continue our product development efforts.
If we are unable to manufacture our products in sufficient quantities or obtain regulatory
approvals for our manufacturing facilities, or if our manufacturing process is found to infringe a
valid patented process or processes of another company, then we may be unable to meet demand for
our products and lose potential revenue.
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To complete our clinical trials and commercialize our product candidates, if approved, we will
need access to, or development of, facilities to manufacture a sufficient supply of our product
candidates. We have used manufacturing facilities we constructed in Houston, Texas to manufacture
ADVEXIN therapy, INGN 241 and other product candidates for currently planned clinical trials. We
anticipate our facilities are suitable for the initial commercial launch of ADVEXIN therapy. We
have no experience manufacturing ADVEXIN therapy, INGN 241 or any other product candidates in the
volumes necessary to support commercial sales. If we are unable to manufacture our product
candidates in clinical or, when necessary, commercial quantities, then we will need to rely on
third-party manufacturers to produce our products for clinical and commercial purposes. These
third-party manufacturers must receive FDA approval before they can produce clinical material or
commercial product. Our products may be in competition with other products for access to these
facilities and may be subject to delays in manufacture if third parties give other products greater
priority than ours. In addition, we may not be able to enter into any necessary third-party
manufacturing arrangements on acceptable terms. There are a limited number of contract
manufacturers who currently have the capability to produce ADVEXIN therapy, INGN 241 or our other
product candidates, and the inability of any of these contract manufacturers to deliver our
required quantities of product candidates timely and at commercially reasonable prices would
negatively affect our operations.
Before we can begin commercially manufacturing ADVEXIN therapy, INGN 241 or any other product
candidate, we must obtain regulatory approval of our manufacturing facilities and process.
Manufacturing of our product candidates for clinical and commercial purposes must comply with the
FDAs CGMP requirements, and foreign regulatory requirements. The CGMP requirements govern quality
control and documentation policies and procedures. In complying with CGMP and foreign regulatory
requirements, we will be obligated to expend time, money and effort in production, record keeping and quality control
to assure the product meets applicable specifications and other requirements. We must also pass a
FDA inspection prior to FDA approval.
Our current manufacturing facilities have not yet been subject to a Pre-Approval Inspection by
the FDA or other global regulatory authorities. Failure to pass Pre-Approval Inspections may
significantly delay approval of our products. If we fail to comply with these requirements, we
would be subject to possible regulatory action and may be limited in the jurisdictions in which we
are permitted to sell our products. Further, the FDA and foreign regulatory authorities have the
authority to perform unannounced periodic inspections of our manufacturing facilities to ensure
compliance with CGMP and foreign regulatory requirements. Our facilities in Houston, Texas are our
only manufacturing facilities. If these facilities were to incur significant damage or destruction,
then our ability to manufacture ADVEXIN therapy, INGN 241 or any other product candidates would be
significantly hampered, and our pre-clinical testing, clinical trials and commercialization efforts
would be delayed.
In order to produce our products in the quantities we believe will be required to meet
anticipated market demand, if our products are approved, we will need to increase, or scale-up,
our production process. If we are unable to do so, or if the cost of this scale-up is not
economically viable to us, we may not be able to produce our products in a sufficient quantity to
meet the requirements of future demand.
Canji controls a United States patent and the corresponding international applications,
including a European counterpart, relating to the purification of viral or adenoviral compositions.
While we believe our manufacturing process does not infringe this patent, Canji could still assert
a claim against us. We may also become subject to infringement claims or litigation if our
manufacturing process infringes other patents. The defense and prosecution of intellectual property
suits and related legal and administrative proceedings are costly and time-consuming to pursue, and
their outcome is uncertain.
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We rely on a limited number of suppliers for some of our manufacturing materials. Any problems
experienced by such suppliers could negatively affect our operations.
We rely on third-party suppliers for most of the equipment, materials and supplies used in the
manufacturing of ADVEXIN therapy, INGN 241 and our other product candidates. Some items critical to
the manufacture of these product candidates are available from only a limited number of suppliers
or vendors. We do not have supply agreements with these key suppliers. To mitigate the related
supply risk, we maintain inventories of these items. Any significant problem experienced by one or
more of this limited number of suppliers could result in a delay or interruption in the supply of
materials to us until the supplier cures the problem or until we locate an alternative source of
supply. Such problems would likely lead to a delay or interruption in our manufacturing operations
or could require a significant modification to our manufacturing process, which could impair our
ability to manufacture our product candidates in a timely manner and negatively affect our
operations.
If product liability lawsuits are successfully brought against us, we may incur substantial
damages and demand for our product candidates may be reduced.
The testing and marketing of medical products is subject to an inherent risk of product
liability claims. Regardless of their merit or eventual outcome, product liability claims may
result in:
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decreased demand for our product candidates; |
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injury to our reputation and significant media attention; |
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withdrawal of clinical trial volunteers; |
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substantial delay in FDA or foreign regulatory authority approval; |
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costs of litigation; and |
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substantial monetary awards to plaintiffs. |
We currently maintain product liability insurance with coverage of $5.0 million per occurrence
with a $10.0 million annual aggregate limit. This coverage may not be sufficient to protect us
fully against product liability claims. We intend to expand our product liability insurance
coverage beyond clinical trials to include the sale of commercial products if we obtain marketing
approval
for any of our product candidates. Our inability to obtain sufficient product liability
insurance at an acceptable cost to protect against product liability claims could prevent or limit
the commercialization of our products.
We use hazardous materials in our business, and any claims relating to improper handling,
storage or disposal of these materials could harm our business.
Our business involves the use of a broad range of hazardous chemicals and materials.
Environmental laws impose stringent civil and criminal penalties for improper handling, disposal
and storage of these materials. In addition, in the event of an improper or unauthorized release
of, or exposure of individuals to, hazardous materials, we could be subject to civil damages due to
personal injury or property damage caused by the release or exposure. A failure to comply with
environmental laws could result in fines and the revocation of environmental permits, which could
prevent us from conducting our business.
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Our stock price may fluctuate substantially.
The market price for our common stock will be affected by a number of factors, including:
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progress and results of our pre-clinical and clinical trials; |
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announcement of technological innovations by us or our competitors; |
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developments concerning proprietary rights, including patent and litigation matters; |
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publicity regarding actual or potential results with respect to products under
development by us or by our competitors; |
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regulatory developments; |
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the announcement of new products by us or our competitors; |
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quarterly variations in our or our competitors results of operations; |
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failure to achieve operating results projected by securities analysts; |
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changes in earnings estimates or recommendations by securities analysts; |
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developments in our industry; and |
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general market conditions and other factors. |
In addition, stock prices for many companies in the technology and emerging growth sectors
have experienced wide fluctuations that have often been unrelated to the operating performance of
such companies.
If we do not progress in our programs as anticipated, our stock price could decrease.
For planning purposes, we estimate the timing of a variety of clinical, regulatory and other
milestones, such as when a certain product candidate will enter clinical development, when a
clinical trial will be completed or when an application for regulatory approval will be filed. Some
of our estimates are included in our Annual Report on Form 10-K for the year ended December 31,
2005, filed with the SEC on March 16, 2006, as amended by our Form 10-K/A filed with the SEC on
November 6, 2006. Our estimates are based on present facts and a variety of assumptions. Many of
the underlying assumptions are outside of our control. If milestones are not achieved when we
expect them to be, investors could be disappointed, and our stock price may decrease.
Any acquisition we might make may be costly and difficult to integrate, may divert management
resources or dilute stockholder value.
As part of our business strategy, we may acquire assets or businesses principally relating to
or complementary to our current operations, and we have in the past evaluated and discussed such
opportunities with interested parties. Any acquisitions we undertake will be accompanied by the
risks commonly encountered in business acquisitions. These risks include, among other things:
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the difficulty and expense of assimilating the operations and personnel of
acquired businesses; |
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diversion of management time and attention and other resources; |
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loss of key employees and customers as a result of changes in management; |
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the incurrence of amortization expense; and |
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possible dilution to our stockholders. |
In addition, geographic distances may make the integration of businesses more difficult. We
may not be successful in overcoming these risks or any other problems encountered in connection
with any acquisitions.
If we lose key personnel or are unable to attract and retain additional, highly skilled
personnel required to develop our products or obtain new collaborations, our business will suffer.
We depend, to a significant extent, on the efforts of our key employees, including senior
management and senior scientific, clinical, regulatory, manufacturing and other personnel. The
development of new therapeutic products requires expertise from a number of different disciplines,
some of which is not widely available. We depend upon our scientific staff to discover new product
candidates and to develop and conduct pre-clinical studies of those new potential products. Our
clinical and regulatory staff is responsible for the design and execution of clinical trials in
accordance with FDA and foreign regulatory authority requirements and for the advancement of our
product candidates toward FDA and foreign regulatory authority approval. Our manufacturing staff is
responsible for designing and conducting our manufacturing processes in accordance with the FDAs
CGMP requirements. The quality and reputation of our scientific, clinical, regulatory and
manufacturing staff, especially the senior staff, and their success in performing their
responsibilities, are a basis on which we attract potential funding sources and collaborators. In
addition, our Chief Executive Officer and other executive officers are involved in a broad range of
critical activities, including providing strategic and operational guidance. The loss of these
individuals, or our inability to retain or recruit other key management and scientific, clinical,
regulatory, manufacturing and other personnel, may delay or prevent us from achieving our business
objectives. We face intense competition for personnel from other companies, universities, public
and private research institutions, government entities and other organizations.
Future changes in financial accounting standards or practices or existing taxation rules or
practices may cause adverse unexpected financial reporting fluctuations and affect our reported
results of operations.
A change in accounting standards or practices or a change in existing taxation rules or
practices can have a significant effect on our reported results and may even affect our reporting
of transactions completed before the change is effective. New accounting pronouncements and
taxation rules and varying interpretations of accounting pronouncements and taxation practice have
occurred and may occur in the future. Changes to existing rules or the questioning of current
practices may adversely affect our reported financial results or the way we conduct our business.
For example, SFAS 123R, Share-Based Payment, became effective for us on January 1, 2006. This
statement requires that employee share-based compensation be measured based on its fair value on
the grant date and treated as an expense that is reflected in the financial statements over the
related service period. SFAS 123R has had a significant impact on our results of operations for the
three and nine months ended September 30, 2006. Using the Black-Scholes option pricing model to
compute share-based compensation expense as we do requires extensive use of accounting judgment and
financial estimates. Items requiring estimation include the
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expected term optionholders will retain their vested stock options before exercising them, the
estimated volatility of our common stock price over the expected term of a stock option and the
number of stock options that will be forfeited prior to the completion of their vesting
requirements. Application of alternative assumptions could result in significantly different
share-based compensation amounts being recorded in our financial statements. We anticipate that
SFAS No. 123R will continue to have a significant impact on our results of operations for 2007 and
subsequent periods.
Our corporate governance structure, including provisions in our certificate of incorporation
and by-laws, and Delaware law, may prevent a change in control or management that stockholders may
consider desirable.
Section 203 of the Delaware General Corporation Law and our certificate of incorporation and
by-laws contain provisions that might enable our management to resist a takeover of our company or
discourage a third party from attempting to take over our company. These provisions include the
inability of stockholders to act by written consent or to call special meetings, the ability of our
board of directors to designate the terms of and issue new series of preferred stock without
stockholder approval and the fact that our board of directors is divided into three classes serving
staggered thee-year terms.
These provisions could have the effect of delaying, deferring, or preventing a change in
control of us or a change in our management that stockholders may consider favorable or beneficial.
These provisions could also discourage proxy contests and make it more difficult for stockholders
to elect directors and take other corporate actions. These provisions could also limit the price
that investors might be willing to pay in the future for shares of our common stock or our other
securities.
Some of our insiders are parties to transactions with us that may cause conflicting
obligations.
Dr. John N. Kapoor, the Chairman of our Board of Directors, is also associated with EJ
Financial Enterprises, Inc. (EJ Financial), a healthcare investment firm that is wholly owned by
him, and therefore may have conflicts of interest in allocating his time among us and his other
business activities, and he may have legal obligations to multiple entities. We have entered into a
consulting agreement with EJ Financial. The consulting agreement provides we will pay EJ Financial
$175,000 per year for certain management consulting services, which is based on anticipated time
spent by EJ Financial personnel on our affairs. EJ Financial is also involved in the management of
healthcare companies in various fields, and Dr. Kapoor is involved in various capacities with the
management and operation of these companies. In addition, EJ Financial is involved with other
companies in the cancer field. Although these companies are pursuing different therapeutic
approaches for the treatment of cancer, discoveries made by one or more of these companies could
render our products less competitive or obsolete.
David Parker, Ph.D., J.D., our Vice President, Intellectual Property, is a partner with the
law firm Fulbright & Jaworski LLP, which provides legal services to us as our primary outside
counsel for intellectual property matters.
In October 2004, we acquired all of the outstanding capital stock of Magnum Therapeutics
Corporation (Magnum), a company owned at the time of this acquisition by one of our executive
officers. We paid approximately $1.75 million for the Magnum stock by (1) issuing approximately
252,000 shares of our common stock valued at approximately $1.48 million at the acquisition date
and (2) assuming liabilities of approximately $272,000. With respect to the common stock we issued
for the acquisition, 50% of the shares were held by an independent escrow agent for a period of
approximately one year subsequent to the acquisition date to satisfy the indemnification
obligations of the selling shareholder under terms of the purchase agreement. Such shares have
since been released from escrow. Magnums
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primary asset is the funding it receives under a research grant from the NIH, which
supplements our ongoing research and development programs. During the three months ended March 31,
2006, we earned $163,000 of revenue under this grant, which completed the funding available to us
under this grant. In the event certain of Magnums technologies result in commercial products, we
may be obligated to pay royalties related to the sales of those products to certain third parties.
We have relationships with Jack A. Roth, M.D., and M. D. Anderson Cancer Center, both of whom
are affiliated with The Board of Regents of the University of Texas System, one of our
stockholders. For more information concerning these relationships, see our Notes to Consolidated
Financial Statements beginning on page F-7 of our Annual Report on Form 10-K for the year ended
December 31, 2005, filed with the SEC on March 16, 2006, as amended by our Form 10-K/A filed with
the SEC on November 6, 2006.
We believe the foregoing transactions with insiders were and are in our best interests and the
best interests of our stockholders. However, the transactions may cause conflicts of interest with
respect to those insiders.
DISCLOSURE REGARDING FORWARD-LOOKING STATEMENTS
Certain statements in this prospectus and the documents incorporated herein by reference are
forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as
amended (Securities Act), and Section 21E of the Securities and Exchange Act of 1934, as amended
(Exchange Act), that involve risks and uncertainties. Any statements contained herein (including
without limitation statements to the effect that we estimate, expect, anticipate, plan,
believe, project, continue, may, or will or statements concerning potential or
opportunity or variations thereof or comparable terminology or the negative thereof) that are not
statements of historical fact should be construed as forward-looking statements. These statements
are not guarantees of future performance and are subject to certain risks, uncertainties and
assumptions that are difficult to predict. Actual results could differ materially and adversely
from those anticipated in such forward-looking statements as a result of certain factors, including
those described in the prospectus under Risk Factors. Because of these and other factors that may
affect our operating results, past performance should not be considered an indicator of future
performance and investors should not use historical results to anticipate results or trends in
future periods. We undertake no obligation to revise or publicly release the results of any
revision to these forward-looking statements. Readers should carefully review the risk factors
described in other documents we file from time to time with the SEC including our annual reports on
Form 10-K and our quarterly reports on Form 10-Q.
We have not authorized any person to give any information or to make any representation other
than those contained in this prospectus in connection with this offering. You should not rely on
such information or representation. Neither the delivery of this prospectus nor any sale made
pursuant to this prospectus shall create any implication that the information contained in this
prospectus is correct as of any time subsequent to the date hereof. This prospectus does not
constitute an offer to sell or solicitation of an offer to buy any security other than the common
stock covered by this prospectus.
USE OF PROCEEDS
Unless otherwise indicated in any prospectus supplement, the net proceeds from the sale of
common stock offered by this prospectus will be used for general corporate purposes and working
capital requirements. We may also use a portion of the net proceeds to fund possible investments
in and acquisitions of complimentary businesses, partnerships, minority investments, products or
technologies.
Currently, there are no commitments or agreements regarding such acquisitions or investments
that are
-19-
material. Pending their ultimate use, we intend to invest the net proceeds in money
market funds, commercial paper and governmental and non-governmental debt securities with
maturities of up to five years.
PLAN OF DISTRIBUTION
We may from time to time sell any or all of the shares of common stock on any stock exchange,
market or trading facility on which the shares are traded or in private transactions. These sales
may be at fixed or varying prices, at or related to prevailing market prices or at negotiated
prices. We may use any one or more of the following methods when selling the shares of common
stock:
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ordinary brokerage transactions and transactions in which underwriters, dealers or
agents solicit purchasers; |
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block trades in which underwriters, dealers or agents will attempt to sell the shares as agent but may position and resell a portion of the block as principal to
facilitate the transaction; |
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purchases by an underwriter, dealer or agent as principal and resale by the
underwriter, dealer or agent for its account pursuant to its prospectus; |
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an over-the-counter distribution in accordance with the rules of the Nasdaq Global Market; |
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privately negotiated transactions; |
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underwriters, dealers or agents may agree to sell a specified number of such shares
at a stipulated price per share; |
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a combination of any such methods of sale; and |
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any other method permitted pursuant to applicable law. |
We will describe the method of distribution of common stock in the applicable prospectus
supplement.
Underwriters, dealers or agents may receive compensation in the form of discounts, concessions
or commissions, in amounts to be negotiated, from us (or, if any underwriter, dealer or agent acts
as agent for the purchaser of shares, from the purchaser) in connection with the sale of common
stock. These underwriters, dealers and agents may qualify as underwriters within the meaning of
the Securities Act. As a result, discounts, commissions or profits on resales received by
underwriters, dealers and agents may be treated as underwriting discounts and commissions. Each
prospectus supplement will identify any underwriter, dealer or agent and describe any compensation
received by them from us. Any initial public offering price and any discounts or concessions
allowed or reallowed or paid to dealers may be changed from time to time.
Underwriters, dealers and agents may be entitled to indemnification by us against certain
civil liabilities, including liabilities under the Securities Act, or to contribution with respect
to payments made by the underwriters, dealers and agents under agreements between us and the
underwriters, dealers and agents.
We may grant underwriters who participate in the distribution of common stock the option to
purchase additional securities to cover over-allotments, if any, in connection with the
distribution.
-20-
In connection with the offering of common stock, certain persons participating in such
offering may engage in transactions that stabilize, maintain or otherwise affect the market prices
of such common stock, including stabilizing transactions, syndicate covering transactions and the
imposition of penalty bids. Specifically, such persons may overallot in connection with the
offering and may bid for and purchase the common stock in the open market. We will describe any of
these activities known to us in the applicable prospectus supplement.
Underwriters or agents and their associates may be customers of, engage in transactions with
or perform services for us in the ordinary course of business.
To the extent required, this prospectus may be amended and supplemented from time to time to
describe a specific plan of distribution.
LEGAL MATTERS
The validity of the common stock being registered hereby is being passed upon for us by Wilson
Sonsini Goodrich & Rosati, Professional Corporation, Austin, Texas.
EXPERTS
Ernst & Young LLP, independent registered public accounting firm, has audited our consolidated
financial statements included in our Annual Report on Form 10-K for the year ended December 31,
2005, as amended by our Form 10-K/A filed with the SEC on November 6, 2006, and managements
assessment of the effectiveness of our internal control over financial reporting as of December 31,
2005, as set forth in its reports, which are incorporated by reference into this prospectus and
elsewhere in the Registration Statement. Our financial statements and managements assessment are
incorporated by reference in reliance on Ernst & Young LLPs reports, given on its authority as
experts in accounting and auditing.
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE
The SEC allows us to incorporate by reference the information we file with them, which means
that we can disclose important information to you by referring you to documents that we have
previously filed with the SEC or documents that we will file with the SEC in the future. The
information incorporated by reference is considered to be part of this prospectus, and later
information that we file with the SEC will automatically update and supersede this information. We
incorporate by reference into this prospectus any filings made by us with the SEC under Sections
13(a), 13(c), 14 or 15(d) of the Exchange Act after the date of this prospectus until the
termination of this offering (except for information contained in any such filing where we indicate
that such information is being furnished and not filed under the Exchange Act), as well as the
following documents:
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our Annual Report on Form 10-K for the fiscal year ended December 31, 2005, filed
with the SEC on March 16, 2006, as amended by our Form 10-K/A filed with the SEC on
November 6, 2006; |
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our Definitive Proxy Statement, filed with the SEC on April 13, 2006; |
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our Quarterly Report on Form 10-Q for the quarter ended March 31, 2006, filed with
the SEC on May 10, 2006; |
-21-
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our Quarterly Report on Form 10-Q for the quarter ended June 30, 2006, filed with
the SEC on August 9, 2006; |
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our Quarterly Report on Form 10-Q for the quarter ended September 30, 2006, filed
with the SEC on November 6, 2006; |
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our Current Report on Form 8-K filed with the SEC on February 24, 2006; |
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our Current Report on Form 8-K filed with the SEC on May 30, 2006; |
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our Current Report on Form 8-K filed with the SEC on November 7, 2006 (Film No.:
061194932); |
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our Current Report on Form 8-K filed with the SEC on November 16, 2006; |
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our Current Report on Form 8-K filed with the SEC on December 11, 2006; |
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our Current Report on Form 8-K filed with the SEC on December 14, 2006; |
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our Current Report on Form 8-K filed with the SEC on December 21, 2006; and |
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the description of our common stock contained in our Registration Statement on Form
8-A, filed with the SEC on September 8, 2000, and any further amendment or report filed
hereafter for the purpose of updating such description. |
This prospectus may contain information that updates, modifies or is contrary to information
in one or more of the documents incorporated by reference into this prospectus. Reports we file
with the SEC after the date of this prospectus may also contain information that updates, modifies
or is contrary to information in this prospectus or in documents incorporated by reference into
this prospectus. Investors should review these reports as they may disclose a change in our
business, prospects, financial condition or other affairs after the date of this prospectus.
You may request a copy of any of these filings, at no cost to you, by writing or telephoning
us at the following address and telephone number: Introgen Therapeutics, Inc., 301 Congress Avenue,
Suite 1850, Austin, Texas 78701; telephone number (512) 708-9310. These filings are also available
from the SECs website and Public Reference Room described under the heading Where You Can Find
More Information.
Additionally, we make these filings available, free of charge, on our website at
www.introgen.com as soon as reasonably practicable after we electronically file such materials
with, or furnish them to, the SEC. The information on the website listed above, other than these
filings, is not, and should not be, considered part of this prospectus and is not incorporated by
reference into this document.
WHERE YOU CAN FIND MORE INFORMATION
We file annual, quarterly and periodic reports, proxy statements and other information with
the SEC. You may inspect these documents without charge at the principal office of the SEC located
at 100 F Street, N.E., Washington, D.C. 20549, and you may obtain copies of these documents from
the SECs Public Reference Room at its principal office. Information regarding the operation of
the Public Reference Room may be obtained by calling 1-800-SEC-0330. The SEC maintains a website
that
-22-
contains reports, proxy and information statements and other information regarding registrants
that file electronically with the SEC. The address of the SECs website is www.sec.gov.
DISCLOSURE OF SEC POSITION ON INDEMNIFICATION
FOR SECURITIES ACT LIABILITIES
We are organized under the laws of the State of Delaware. Our Certificate of Incorporation,
as amended, and bylaws, as amended, eliminate the personal liability of our directors to the
fullest extent permitted by the Delaware General Corporation Law. In addition, our Certificate of
Incorporation, as amended, and bylaws, as amended, provide indemnity for our current or former
officers and directors against all liabilities and costs of defending an action or suit in which
they were involved by reason of their positions with us. However, we cannot indemnify any person
if a court finds that the person did not act in good faith. Our bylaws, as amended, also provide
that we may purchase insurance to protect any director, officer, employee or agent against any
liability. We have entered into separate indemnification agreements with each of our directors and
executive officers, whereby we have agreed, among other things, to indemnify them to the fullest
extent permitted by the Delaware General Corporation Law, subject to specified limitations, against
certain liabilities actually incurred by them in any proceeding in which they are a party that may
arise by reason of their status as directors, officers, employees or agents or may arise by reason
of their serving as such at our request for another entity and to advance their expenses incurred
as a result of any proceeding against them as to which they could be indemnified. We intend to
enter into similar separate indemnification agreements with any directors or officers who may join
us in the future. There is no pending litigation or proceeding involving any of our directors,
officers, employees or other agents as to which indemnification is being sought nor are we aware of
any pending or threatened litigation that may result in claims for indemnification.
Insofar as indemnification for liabilities arising under the Securities Act may be permitted
to directors, officers or controlling persons pursuant to the foregoing provisions, we have been
informed that in the opinion of the SEC such indemnification is against public policy as expressed
in the Securities Act, and is therefore unenforceable.
-23-
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 14. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION
The following table sets forth the costs and expenses, other than underwriting discounts,
commissions and concessions, payable by the Registrant in connection with the sale of common stock
being registered hereby. All amounts are estimates except the SEC registration fee.
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Amount to Be Paid by |
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Registrant(1) |
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SEC registration fee |
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$ |
16,050 |
(2) |
Legal fees and expenses |
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$ |
150,000 |
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Accounting fees and expenses |
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$ |
50,000 |
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Printing and engraving expenses |
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$ |
50,000 |
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Transfer agent and registrar expenses |
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$ |
25,000 |
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Miscellaneous expenses |
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$ |
50,000 |
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Total |
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$ |
341,050 |
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(1) |
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Each of the amounts set forth above, other than the SEC registration fee, is an estimate. |
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(2) |
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$608.38 of the registration fee previously paid by the Registrant in connection with our
Registration Statement on Form S-3 (File No. 333-107799) filed August 8, 2003, is applied to
and offset against the registration fee currently due. |
ITEM 15. INDEMNIFICATION OF DIRECTORS AND OFFICERS
We are organized under the laws of the State of Delaware. Our Certificate of Incorporation,
as amended, and bylaws, as amended, eliminate the personal liability of our directors to the
fullest extent permitted by the Delaware General Corporation Law. In addition, our Certificate of
Incorporation, as amended, and bylaws, as amended, provide indemnity for our current or former
officers and directors against all liabilities and costs of defending an action or suit in which
they were involved by reason of their positions with us. However, we cannot indemnify any person
if a court finds that the person did not act in good faith. Our bylaws, as amended, also provide
that we may purchase insurance to protect any director, officer, employee or agent against any
liability. We have entered into separate indemnification agreements with each of our directors and
executive officers, whereby we have agreed, among other things, to indemnify them to the fullest
extent permitted by the Delaware General Corporation Law, subject to specified limitations, against
certain liabilities actually incurred by them in any proceeding in which they are a party that may
arise by reason of their status as directors, officers, employees or agents or may arise by reason
of their serving as such at our request for another entity and to advance their expenses incurred
as a result of any proceeding against them as to which they could be indemnified. We intend to
enter into similar separate indemnification agreements with any directors or officers who may join
us in the future. There is no pending litigation or proceeding involving any of our directors,
officers, employees or other agents as to which indemnification is being sought nor are we aware of
any pending or threatened litigation that may result in claims for indemnification.
ITEM 16. EXHIBITS
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Exhibit Number |
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Description of Exhibit |
1.1(1)
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Form of Underwriting Agreement |
II-1
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Exhibit Number |
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Description of Exhibit |
4.1(2)
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Specimen Common Stock Certificate |
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4.2(3)
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Certificate of Incorporation as currently in effect |
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4.3(3)
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Amendment to Certificate of Incorporation, effective as of December 21, 2001 |
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4.4(4)
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Amendment to Certificate of Incorporation, effective as of August 6, 2004 |
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4.5(5)
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Bylaws of Introgen as currently in effect |
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5.1
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Opinion of Wilson Sonsini Goodrich & Rosati, Professional Corporation |
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23.1(6)
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Consent of Wilson Sonsini Goodrich & Rosati, Professional Corporation |
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23.2
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Consent of Ernst & Young LLP, Independent Registered Public Accounting Firm |
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24.1
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Power of Attorney (see page II-5 of this Registration Statement) |
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(1) |
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To be filed by amendment or as an exhibit to a report pursuant to Section 13(a) or 15(d) of
the Exchange Act and as incorporated herein by reference. |
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(2) |
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Incorporated by reference to the same-numbered exhibit filed with Amendment No. 2 to the
Registration Statement on Form S-1 (No. 333-30582), filed with the SEC on September 8, 2000. |
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(3) |
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Incorporated by reference to the same-numbered exhibit filed with our Transition Report on
Form 10-KT for the six-month transition period ended December 31, 2001 (File No. 000-21291),
filed with the SEC on March 20, 2002. |
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(4) |
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Incorporated by reference to the same-numbered exhibit filed with our Quarterly Report on
Form 10-Q for the quarter ended June 30, 2004 (File No. 000-21291), filed with the SEC on
August 16, 2004. |
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(5) |
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Incorporated by reference to the same-numbered exhibit filed with our Quarterly Report on
Form 10-Q for the quarter ended December 31, 2000 (File No. 000-21291), filed with the SEC on
February 14, 2001. |
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(6) |
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Included in Exhibit 5.1. |
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;
(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 SEC 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;
(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 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 or Form F-3 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 SEC by the Registrant pursuant to Section 13 or Section 15(d) of the Exchange Act
that are incorporated by reference
II-2
in the Registration Statement, or is contained in a form of prospectus filed pursuant to Rule
424(b) that is part of the Registration Statement.
(2) 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.
(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.
(4) That, for the purpose of determining liability under the Securities Act to any purchaser:
(i) Each prospectus filed by the Registrant pursuant to Rule 424(b)(3) shall be deemed to be
part of the Registration Statement as of the date the filed prospectus was deemed part of and
included in the Registration Statement; and
(ii) Each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5) or (b)(7) as part
of a Registration Statement in reliance on Rule 430B relating to an offering made pursuant to Rule
415(a)(1)(i), (vii) or (x) for the purpose of providing the information required by Section 10(a)
of the Securities Act shall be deemed to be part of and included in the Registration Statement as
of the earlier of the date such form of prospectus is first used after effectiveness or the date of
the first contract of sale of securities in the offering described in the prospectus. As provided
in Rule 430B, for liability purposes of the issuer and any person that is at that date an
underwriter, such date shall be deemed to be a new effective date of the Registration Statement
relating to the securities in the Registration Statement to which that prospectus relates, and the
offering of such securities at that time shall be deemed to be the initial bona fide offering
thereof. Provided, however, that no statement made in a Registration Statement or prospectus that
is part of the Registration Statement or made in a document incorporated or deemed incorporated by
reference into the Registration Statement or prospectus that is part of the Registration Statement
will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or
modify any statement that was made in the Registration Statement or prospectus that was part of the
Registration Statement or made in any such document immediately prior to such effective date.
(5) That, for the purpose of determining liability of the Registrant under the Securities Act
to any purchaser in the initial distribution of the securities:
The undersigned Registrant undertakes that in a primary offering of securities of the
undersigned Registrant pursuant to this Registration Statement, regardless of the underwriting
method used to sell the securities to the purchaser, if the securities are offered or sold to such
purchaser by means of any of the following communications, the undersigned Registrant will be a
seller to the purchaser and will be considered to offer or sell such securities to such purchaser:
(i) Any preliminary prospectus or prospectus of the undersigned Registrant relating to the
offering required to be filed pursuant to Rule 424;
(ii) Any free writing prospectus relating to the offering prepared by or on behalf of the
undersigned Registrant or used or referred to by the undersigned Registrant;
II-3
(iii) The portion of any other free writing prospectus relating to the offering containing
material information about the undersigned Registrant or its securities provided by or on behalf of
the undersigned Registrant; and
(iv) Any other communication that is an offer in the offering made by the undersigned
Registrant to the purchaser.
(b) The undersigned Registrant hereby undertakes that, for purposes of determining any
liability under the Securities Act, each filing of the Registrants annual report pursuant to
Section 13(a) or Section 15(d) of the Exchange Act (and, where applicable, each filing of an
employee benefit plans annual report pursuant to Section 15(d) of the Exchange Act) 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.
(c) 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
provisions described under Item 15 above, or otherwise, the Registrant has been advised that in the
opinion of the SEC 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.
(d) The undersigned Registrant hereby undertakes that:
(1) For 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 this Registration Statement
as of the time it was declared effective; and
(2) For 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-4
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 for filing on Form S-3 and has
duly caused this Registration Statement on Form S-3 to be signed on its behalf by the undersigned,
thereunto duly authorized, in the City of Austin, State of Texas, on
January 26, 2007.
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INTROGEN THERAPEUTICS, INC.
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By: |
/s/ David G. Nance
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David G. Nance |
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President and Chief Executive Officer |
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POWER OF ATTORNEY
We, the undersigned officers and directors of Introgen Therapeutics, Inc., do hereby
constitute and appoint David G. Nance and James W. Albrecht, Jr., or either of them, our true and
lawful attorneys-in-fact and agents, each with full power of substitution and resubstitution, for
him and in his name, place and stead, in any and all capacities, to sign any and all amendments to
this Registration Statement, and to file the same, with exhibits thereto, and other documents in
connection therewith, with the SEC, granting unto said attorneys-in-fact and agents, and each of
them, full power and authority to do and perform each and every act and thing requisite are
necessary to be done in and about the premises, as fully to all intents and purposes as he might or
could do in person, hereby ratifying and confirming all that each of said attorney-in-fact and
agents, or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Act, this Registration Statement on Form S-3
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/ David G. Nance
(David G. Nance)
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President, Chief Executive
Officer and Director (Principal
Executive Officer)
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January 26, 2007 |
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/s/ James W. Albrecht, Jr.
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Chief Financial Officer
(Principal Financial and
Accounting Officer)
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January 26, 2007 |
(James W. Albrecht, Jr.) |
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/s/ John N. Kapoor, Ph.D. |
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Chairman of the Board and Director
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January 29, 2007 |
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/s/ William H. Cunningham, Ph.D. |
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(William H. Cunningham, Ph.D.)
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Director
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January 29, 2007 |
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/s/ Charles E. Long |
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Director
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January 29, 2007 |
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/s/ S. Malcolm Gillis, Ph.D. |
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(S. Malcolm Gillis, Ph.D.)
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Director
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January 29, 2007 |
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/s/ Peter Barton Hutt |
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Director
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January 29, 2007 |
II-5
INDEX TO EXHIBITS
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Exhibit Number |
|
Description of Exhibit |
1.1(1)
|
|
Form of Underwriting Agreement |
|
|
|
4.1(2)
|
|
Specimen Common Stock Certificate |
|
|
|
4.2(3)
|
|
Certificate of Incorporation as currently in effect |
|
|
|
4.3(3)
|
|
Amendment to Certificate of Incorporation, effective as of December 21, 2001 |
|
|
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4.4(4)
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Amendment to Certificate of Incorporation, effective as of August 6, 2004 |
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4.5(5)
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Bylaws of Introgen as currently in effect |
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5.1
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Opinion of Wilson Sonsini Goodrich & Rosati, Professional Corporation |
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23.1(6)
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Consent of Wilson Sonsini Goodrich & Rosati, Professional Corporation |
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23.2
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Consent of Ernst & Young LLP, Independent Registered Public Accounting Firm |
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24.1
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Power of Attorney (see page II-5 of this Registration Statement) |
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(1) |
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To be filed by amendment or as an exhibit to a report pursuant to Section 13(a) or 15(d) of
the Exchange Act and as incorporated herein by reference. |
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(2) |
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Incorporated by reference to the same-numbered exhibit filed with Amendment No. 2 to the
Registration Statement on Form S-1 (No. 333-30582), filed with the SEC on September 8, 2000. |
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(3) |
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Incorporated by reference to the same-numbered exhibit filed with our Transition Report on
Form 10-KT for the six-month transition period ended December 31, 2001 (File No. 000-21291),
filed with the SEC on March 20, 2002. |
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(4) |
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Incorporated by reference to the same-numbered exhibit filed with our Quarterly Report on
Form 10-Q for the quarter ended June 30, 2004 (File No. 000-21291), filed with the SEC on
August 16, 2004. |
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(5) |
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Incorporated by reference to the same-numbered exhibit filed with our Quarterly Report on
Form 10-Q for the quarter ended December 31, 2000 (File No. 000-21291), filed with the SEC on
February 14, 2001. |
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(6) |
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Included in Exhibit 5.1. |
II-6