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As filed with the Securities and Exchange Commission on June 2, 2006
Registration No. 333-
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM S-3
REGISTRATION STATEMENT UNDER
THE SECURITIES ACT OF 1933
Dynavax Technologies Corporation
(Exact name of registrant as specified in its charter)
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Delaware
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33-0728374 |
(State or other jurisdiction of incorporation or
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(I.R.S. Employer Identification No.) |
organization) |
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2929 Seventh Street, Suite 100
Berkeley, CA 94710-2753
(510) 848-5100
(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrants Principal
Executive Offices)
Deborah A. Smeltzer
Vice President, Operations and Chief Financial Officer
Dynavax Technologies Corporation
2929 Seventh Street, Suite 100
Berkeley, CA 94710-2753
(510) 848-5100
(Name, Address, Including Zip Code, and Telephone Number, Including Area Code, of Agent For Service)
Copies to:
John W. Campbell, Esq.
Morrison & Foerster LLP
425 Market Street
San Francisco, California 94105
Approximate date of commencement of proposed sale to the public:
From time to time after this registration statement becomes effective.
If the only securities being registered on this form are being offered pursuant to dividend or
interest reinvestment plans, please check the following box. TM
If any of the securities being registered on this Form are to be offered on a delayed or
continuous basis pursuant to Rule 415 under the Securities Act of 1933, other than securities
offered only in connection with dividend or interest reinvestment plans, check the following box.
þ
If this form is filed to register additional securities for an offering pursuant to Rule
462(b) under the Securities Act, please check the following box and list the Securities Act
registration statement number of the earlier effective registration statement for the same
offering.TM
If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities
Act, check the following box and list the Securities Act registration statement number of the
earlier effective registration statement for the same offering. TM
If delivery of the Prospectus is expected to be made pursuant to Rule 434, please check the
following box. TM
CALCULATION OF REGISTRATION FEE
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Proposed maximum |
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Proposed maximum |
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Title of each class of |
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Amount to be |
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offering price per |
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aggregate offering |
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Amount of |
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securities to be registered |
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registered |
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unit (1) |
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price(1) |
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registration fee(1) |
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Common stock, $.01 par value |
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2,000,000 |
(2) |
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$ |
4.37 |
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$ |
8,740,000 |
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$ |
935.18 |
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(1) |
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Estimated pursuant to Rule 457(c) under the Securities Act of 1933 solely for purposes of
calculating the amount of the registration fee, based on the average of the high and low prices per
share of Dynavax Technologies Corporation common stock on May 31, 2006, as reported on The Nasdaq
National Market. |
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(2) |
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Pursuant to Rule 416 under the Securities Act, the number of shares of common stock registered
hereby shall include an indeterminate number of shares of common stock that may be issued in
connection with a stock split, stock dividend, recapitalization or similar event. |
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 Commission, acting pursuant to 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 Securities and Exchange Commission
declares our registration statement effective. This prospectus is not an offer
to sell these securities and is not soliciting an offer to buy these securities
in any state where the offer or sale is not permitted.
PROSPECTUS
SUBJECT TO COMPLETION DATED JUNE 2, 2006
2,000,000 Shares
Common Stock
We have prepared this prospectus to allow the selling stockholders we identify in this
prospectus to sell shares of our common stock issuable by us upon the exercise of common stock
warrants held by the selling stockholders.
We will not receive any of the proceeds from the sale of these shares of common stock by the
selling stockholders. The selling stockholders, or their pledgees, donees, transferees or other
successors-in-interest may offer and sell the common stock directly to purchasers or through
underwriters, broker-dealers or agents, who may receive compensation in the form of discounts,
concessions or commissions. Such sales may be made through public or private transactions at
prevailing market prices, at prices relating to prevailing market prices or at privately negotiated
prices.
Our
common stock trades on the Nasdaq National Market under the trading
symbol DVAX. On June 1, 2006, the last reported sale price of our common stock was $4.40 per share. We recommend that
you obtain current market quotations for our common stock prior to making an investment decision.
Investing in our common stock involves a high degree of risk. Please carefully consider the
Risk Factors beginning on page 1 of this prospectus.
Neither the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or determined if this prospectus is truthful or
complete. Any representation to the contrary is a criminal offense.
The date of this prospectus is , 2006.
TABLE OF CONTENTS
You should rely only on the information contained in or incorporated by reference in this
prospectus. We have not authorized anyone to provide you with different information. We are not
making an offer of these securities in any state where the offer is not permitted. You should
assume that the information in this prospectus is accurate only as of the date on the front of the
document and that any information we have incorporated by reference is accurate only as of the date
of the document incorporated by reference, regardless of the time of delivery of this prospectus or
any sale of our common stock.
SUMMARY
The following summary may not contain all the information that may be important to you. You should
read the entire prospectus, as well as the information to which we refer you and the information
incorporated by reference, before making an investment decision.
DYNAVAX TECHNOLOGIES CORPORATION
Dynavax Technologies Corporation discovers, develops and intends to commercialize innovative
TLR-9 agonist-based products to treat and prevent allergies, infectious diseases and chronic
inflammatory diseases using versatile, proprietary approaches that alter immune system responses in
highly specific ways. We were incorporated in California in August 1996 under the name Double
Helix Corporation, and we changed our name to Dynavax Technologies Corporation in September 1996.
We reincorporated in Delaware in 2001. Our principal offices are located at 2929 Seventh Street,
Suite 100, Berkeley, California 94710-2753. Our telephone number is (510) 848-5100. Our Internet
address is www.dynavax.com. We do not incorporate the information on our website into this
prospectus, and you should not consider it part of this prospectus.
Dynavax Technologies is a registered trademark of Dynavax Technologies Corporation. Each of
the other trademarks, trade names or service marks appearing or incorporated by reference in this
prospectus belongs to its respective holder.
THE OFFERING
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Issuer
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Dynavax Technologies Corporation, a Delaware corporation. |
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Selling Stockholders
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The selling stockholders of our common stock in the offering are named herein. |
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Securities Covered
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2,000,000 shares of common stock issuable upon exercise of common stock
warrants held by the selling stockholders. |
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Plan of Distribution
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The selling stockholders may offer and sell the common stock from time to
time on the NASDAQ National Market or otherwise, directly to purchasers or
through underwriters, broker-dealers or agents. |
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Use of Proceeds
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We will not receive any of the proceeds of sales by the selling stockholders
of any of the securities covered by this prospectus. |
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Trading
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Our common stock is quoted on the Nasdaq National Market under the symbol
DVAX. |
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RISK FACTORS
Investing in our securities involves a high degree of risk. Before making an investment
decision, you should carefully consider the risk factors set forth herein, as well as other
information we include or incorporate by reference in this prospectus and the additional
information in the other reports we file with the Securities and Exchange Commission. If any of the
following risks actually occur, our business could be harmed. In such case, the trading price of
our securities could decline and you could lose all or part of your investment.
We have incurred substantial losses since inception and do not have any commercial products that
generate revenue.
We have experienced significant operating losses in each year since our inception in August
1996. To date, our revenue has resulted from a collaboration agreement with UCB Farchim, S.A. (UCB)
and government and private agency grants. The UCB collaboration agreement ended in March 2005. The
grants are subject to annual review based on the achievement of milestones and other factors and
will terminate in January 2007 at the latest. Our accumulated deficit was $124.1 million as of
March 31, 2006, and we anticipate that we will incur substantial additional operating losses for
the foreseeable future. These losses have been, and will continue to be, principally the result of
the various costs associated with our research and development activities. We expect our losses to
increase primarily as a consequence of our continuing product development efforts.
We do not have any products that generate revenue. In April 2006, we initiated the Dynavax
Allergic Rhinitis TOLAMBA Trial, or DARTT, which is designed to complement data derived from the
recently completed Phase II/III
clinical trial and our ongoing trial in ragweed allergic children. The HEPLISAV pivotal Phase
III trial in Asia and the U.S.-based Phase I trial in patients with pre-hemodialysis are ongoing.
These and our other product candidates may never be commercialized, and we may never generate
product-related revenue. Our ability to generate product revenue depends upon:
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demonstrating in clinical trials that our product candidates are safe and effective, in particular, in the current and
planned trials for TOLAMBA and HEPLISAV; |
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obtaining regulatory approvals for our product candidates in the United States and international markets; |
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entering into collaborative relationships on commercially reasonable terms for the development, manufacturing, sales
and marketing of our product candidates, and then successfully managing these relationships; and |
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obtaining commercial acceptance of our products, in particular TOLAMBA and HEPLISAV. |
If we are unable to generate revenues or achieve profitability, we may be required to
significantly reduce or discontinue our operations or raise additional capital under adverse
circumstances.
If we are unable to secure additional funding, we will have to reduce or discontinue operations.
We believe our existing capital resources will be adequate to satisfy our capital needs for at
least the next twelve months. Because of the significant time and resources it will take to develop
our product candidates, potentially commercialize them and generate revenues, we may require
substantial additional capital resources in order to continue our operations, and any such funding
may not cover our costs of operations. In the event we change our development plans or clinical
programs, we may need additional capital sooner than we currently anticipate.
We expect capital outlays and operating expenditures to increase over the next several years
as we expand our operations. We may be unable to obtain additional capital from financing sources
or from agreements with collaborators on acceptable terms, or at all. If at any time sufficient
capital is not available, we may be required to delay, reduce the scope of, or eliminate some or
all of our research, preclinical or clinical programs or discontinue our operations.
All of our product candidates are unproven, and our success depends on our product candidates being
approved through uncertain and time-consuming regulatory processes. Failure to prove our products
safe and effective in clinical trials and obtain regulatory approvals could require us to
discontinue operations.
None of our product candidates has been approved for sale in the United States or any foreign
market. Any product candidate we develop is subject to extensive regulation by federal, state and
local governmental authorities in the United States, including the FDA, and by foreign regulatory
agencies. Our success is primarily dependent on our ability to obtain regulatory approval for
TOLAMBA, our ragweed allergy product candidate, and HEPLISAV, our hepatitis B vaccine product
candidate. Approval processes in the United States and in other countries are uncertain, take many
years and require the expenditure of substantial resources. Product development failure can occur
at any stage of clinical trials and as a result of many factors, many of which are not under our
control.
We will need to demonstrate in clinical trials that each product candidate is safe and
effective before we can obtain the necessary approvals from the FDA and foreign regulatory
agencies. In early 2006, we announced results from a two-year Phase II/III clinical trial of
TOLAMBA in which the safety profile was favorable. In April 2006, we initiated the DARTT study,
which broadens the TOLAMBA clinical program and is designed to complement data derived from the
recently completed Phase II/III clinical trial and our ongoing trial in ragweed allergic children
initiated in 2005. If we identify any safety issues associated with TOLAMBA, we may be delayed or
prevented from initiating a pivotal Phase III trial for TOLAMBA. We have initiated a pivotal Phase
III trial for HEPLISAV in Asia. We are in the process of planning additional trials designed to
support registration activities. The FDA or foreign regulatory agencies may require us to conduct
additional clinical trials prior to approval in their jurisdictions.
Many new drug candidates, including many drug candidates that have completed Phase III
clinical trials, have shown promising results in early clinical trials and subsequently failed to
establish sufficient safety and efficacy to obtain regulatory
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approval. Despite the time and money
expended, regulatory approvals are never guaranteed. Failure to complete clinical trials and prove
that our products are safe and effective would have a material adverse effect on our ability to
eventually generate revenues and could require us to reduce the scope of or discontinue our
operations.
Our clinical trials may be extended, suspended, delayed or terminated at any time. Even short
delays in the commencement and progress of our trials may lead to substantial delays in the
regulatory approval process for our product candidates, which will impair our ability to generate
revenues.
We may extend, suspend or terminate clinical trials at any time for various reasons, including
regulatory actions by the FDA or foreign regulatory agencies, actions by institutional review
boards, failure to comply with good clinical practice requirements, concerns regarding health risks
to test subjects, or inadequate supply of the product candidate. In addition, our ability to
conduct clinical trials for some of our product candidates, notably TOLAMBA, is limited due to the
seasonal nature of ragweed allergy. Even a small delay in a trial for any product candidate could
require us to delay commencement of the trial until the next appropriate season, which could result
in a delay of an entire year. Our registration and commercial timelines will be dependent on
results of the current and planned clinical trials and further discussions with the FDA.
Consequently, we may experience additional delays in obtaining regulatory approval for these
product candidates.
Extension, suspension, termination or unanticipated delays of our clinical trials for TOLAMBA or HEPLISAV may:
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adversely affect our ability to commercialize or market any product candidates we may develop; |
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impose significant additional costs on us; |
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potentially diminish any competitive advantages that we may attain; |
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adversely affect our ability to enter into collaborations, receive milestone payments or royalties from potential
collaborators; |
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cause us to abandon the development of the affected product candidate; or |
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limit our ability to obtain additional financing on acceptable terms, if at all. |
If third parties successfully assert that we have infringed their patents and proprietary rights or
challenge the validity of our patents and proprietary rights, we may become involved in
intellectual property disputes and litigation that would be costly, time consuming, and delay or
prevent development or commercialization of our product candidates.
We may be exposed to future litigation by third parties based on claims that our product
candidates, proprietary technologies or the licenses on which we rely, infringe their intellectual
property rights, or we may be required to enter into litigation to enforce patents issued or
licensed to us or to determine the scope or validity of another partys proprietary rights. If we
become involved in any litigation, interference or other administrative proceedings related to our
intellectual property or the intellectual property of others, we will incur substantial expenses
and it will divert the efforts of our technical and management personnel. Others may succeed in
challenging the validity of our issued and pending claims.
Two of our potential competitors relative to HEPLISAV, Merck & Co., Inc. and GlaxoSmithKline
Plc, are exclusive licensees of broad patents covering hepatitis B surface antigen. In addition,
the Institute Pasteur also owns or has exclusive licenses to patents covering hepatitis B surface
antigen. While some of these patents have expired or will soon expire outside of the United States,
they remain in force in the United States and are likely to be in force when we commercialize
HEPLISAV or a similar product in the United States. To the extent we were to commercialize HEPLISAV
in the United States, Merck and/or GlaxoSmithKline or the Institute Pasteur may bring claims
against us.
If we are unsuccessful in defending or prosecuting our issued and pending claims or in
defending potential claims against us, for example, as may arise to the extent we were to
commercialize HEPLISAV or any similar product candidate in the United States, we could be required
to pay substantial damages and we may be unable to commercialize our product candidates or use our
proprietary technologies unless we obtain a license from these or other third parties. A license
may require us to pay substantial royalties, require us to grant a cross-license to our technology
or may not be available to us on acceptable terms or on any terms. In addition, we may be required
to redesign our technology so it does not infringe a third partys patents, which may not be
possible or could require substantial funds and time. Any of these outcomes may require us to
change our business strategy and could reduce the value of our business.
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Another of our potential competitors, Coley Pharmaceutical Group (Coley), has issued U.S.
patent claims, as well as patent claims pending with the U.S. Patent and Trademark Office, that, if
held to be valid, could require us to obtain a license in order to commercialize one or more of our
formulations of ISS in the United States, including TOLAMBA and HEPLISAV. In December 2003 the U.S.
Patent and Trademark Office declared an interference to resolve first-to-invent
disputes between a patent application filed by the Regents of the University of California,
which is exclusively licensed to us, and an issued U.S. patent owned by Coley relating to
immunostimulatory DNA sequences. The declaration of interference named the Regents of the
University of California as senior party, indicating that a patent application filed by the Regents
of the University of California and licensed to us was filed prior to a patent application owned by
Coley that led to an issued U.S. patent. The interference provides the first forum to challenge the
validity and priority of certain of Coleys patents. On March 10, 2005, the U.S. Patent and
Trademark Office issued a decision in the interference which did not address the merits of the
case, but dismissed it on a legal technicality related to the timing of Dynavaxs filing of its
claims and request for interference. Dynavax has appealed this decision. If we prevail in the
appeal, we will be able to continue the interference to address the merits of the case. If we
prevail in the interference proceeding, it would establish our founders as the inventors of the
inventions in dispute. However, even a favorable outcome in the interference would not prevent
Coley from asserting its other patents or patent claims, that were not the subject of the
interference, against our ISS products, which could harm our ability to commercialize those
products. If we do not prevail in the interference proceeding, we may not be able to obtain patent
protection on the subject matter of the interference, which would have a material adverse impact on
our business. In addition, if Coley prevails in the interference, it may seek to enforce its rights
under issued claims, including, for example, by suing us for patent infringement. Consequently, we
may need to obtain a license to issued and/or pending claims held by Coley by paying cash, granting
royalties on sales of our products or offering rights to our own proprietary technologies. Such a
license may not be available to us on acceptable terms, if at all.
If we receive regulatory approval for our product candidates, we will be subject to ongoing FDA and
foreign regulatory obligations and continued regulatory review, which may be costly and subject us
to various enforcement actions.
Any regulatory approvals that we receive for our product candidates are likely to contain
requirements for post-marketing follow-up studies, which may be costly. Product approvals, once
granted, may be modified, resulting in limitations on our labeling indications or marketing claims,
or withdrawn completely if problems occur after commercialization. Thus, even if we receive FDA and
other regulatory approvals, our product candidates may later exhibit qualities that limit or
prevent their widespread use or that force us to withdraw those products from the market.
In addition, we or our contract manufacturers will be required to adhere to federal
regulations setting forth current good manufacturing practice. The regulations require that our
product candidates be manufactured and our records maintained in a prescribed manner with respect
to manufacturing, testing and quality control activities. Furthermore, we or our contract
manufacturers must pass a pre-approval inspection of manufacturing facilities by the FDA and
foreign regulatory agencies before obtaining marketing approval and will be subject to periodic
inspection by the FDA and corresponding foreign regulatory agencies under reciprocal agreements
with the FDA. Further, to the extent that we contract with third parties for the manufacture of our
products, our ability to control third-party compliance with FDA requirements will be limited to
contractual remedies and rights of inspection.
Failure to comply with regulatory requirements could prevent or delay marketing approval or
require the expenditure of money or other resources to correct. Failure to comply with applicable
requirements may also result in warning letters, fines, injunctions, civil penalties, recall or
seizure of products, total or partial suspension of production, refusal of the government to renew
marketing applications and criminal prosecution, any of which could be harmful to our ability to
generate revenues and our stock price.
Our product candidates in clinical trials rely on a single lead ISS compound, 1018 ISS, and most of
our earlier stage programs rely on ISS-based technology. Serious adverse safety data relating to
either 1018 ISS or other ISS-based technology may require us to reduce the scope of or discontinue
our operations.
Our product candidates in clinical trials are based on 1018 ISS, and substantially all of our
research and development programs use ISS-based technology. If any of our product candidates in
clinical trials produce serious adverse safety data, we may be required to delay or discontinue all
of our clinical trials. In addition, as all of our clinical product candidates contain 1018 ISS,
potential collaborators may also be reluctant to establish collaborations for our products in
distinct therapeutic areas due to the common safety risk across therapeutic areas. If adverse
safety data are found to apply to our ISS-based technology as a whole, we may be required to
discontinue our operations.
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We have licensed some of our development and commercialization rights to certain of our development
programs in connection with the Symphony Dynamo funding arrangement and will not receive any future
royalties or revenues with respect to this intellectual property unless we exercise an option to
repurchase the programs in the future. We may not obtain sufficient clinical data in order to
determine whether we should exercise this option prior to the
expiration of the development period, and even if we decide to exercise, we may not have the
financial resources to exercise this option in a timely manner.
We have granted an exclusive license to the intellectual property for certain ISS compounds
for cancer, hepatitis B and hepatitis C therapeutics to Symphony Dynamo, Inc. in consideration for
a commitment from Symphony Capital Partners, LP and its co-investors to provide $50 million of
committed capital to advance these programs. The funding is to be provided in two tranches, $30
million of which remains to be provided by the first anniversary of the agreement. As part of the
arrangement, we received an option granting us the exclusive right, but not the obligation, to
acquire certain or all of the programs at specified points in time at specified prices during the
term of the five-year development period. The development programs under the arrangement will be
jointly managed by Symphony Dynamo and us, and there can be no assurance that we will agree on
various decisions that will enable us to successfully develop the potential products, or even if we
are in agreement on the development plans, that the development efforts will result in sufficient
clinical data to make a fully informed decision with respect to the exercise of our option. If we
do not exercise the purchase option prior to its expiration, then our rights in and with respect to
the Symphony Dynamo programs will terminate and we will no longer have rights to any of the
programs licensed to Symphony Dynamo under the arrangement.
If we elect to exercise the purchase option, we will be required to make a substantial
payment, which at our election may be paid partially in shares of our common stock. As a result, in
order to exercise the option, we will be required to make a substantial payment of cash and
possibly issue a substantial number of shares of our common stock. We do not currently have the
resources to exercise the option and we may be required to enter into a financing arrangement or
license arrangement with one or more third parties, or some combination of these in order to
exercise the option, even if we paid a portion of the purchase price with our common stock. There
can be no assurance that any financing or licensing arrangement will be available or even if
available, that the terms would be favorable to us and our stockholders. In addition, the exercise
of the purchase option will likely require us to record a significant charge to earnings and may
adversely impact future operating results.
A key part of our business strategy is to establish collaborative relationships to commercialize
and fund development of our product candidates. We may be unsuccessful in establishing and managing
collaborative relationships, which may significantly limit our ability to develop and commercialize
our products successfully, if at all.
We will need to establish collaborative relationships to obtain domestic and international
sales, marketing and distribution capabilities for our product candidates. We also intend to enter
into collaborative relationships to provide funding to support our research and development
programs. Our collaboration agreement with UCB for TOLAMBA and for grass allergy immunotherapy
ended in March 2005. Future collaboration revenue will depend on our ability to enter into new
collaborative relationships.
The process of establishing collaborative relationships is difficult, time-consuming and
involves significant uncertainty. Moreover, even if we do establish collaborative relationships,
our collaborators may seek to renegotiate or terminate their relationships with us due to
unsatisfactory clinical results, a change in business strategy, a change of control or other
reasons. If any collaborator fails to fulfill its responsibilities in a timely manner, or at all,
our research, clinical development or commercialization efforts related to that collaboration could
be delayed or terminated, or it may be necessary for us to assume responsibility for expenses or
activities that would otherwise have been the responsibility of our collaborator. If we are unable
to establish and maintain collaborative relationships on acceptable terms, we may have to delay or
discontinue further development of one or more of our product candidates, undertake development and
commercialization activities at our own expense or find alternative sources of capital.
We rely on third parties to supply component materials necessary for our clinical product
candidates and manufacture product candidates for our clinical trials. Loss of these suppliers or
manufacturers, or failure to replace them may delay our clinical trials and research and
development efforts and may result in additional costs, which would preclude us from producing our
product candidates on commercially reasonable terms.
We rely on a number of third parties for the multiple steps involved in the manufacturing
process of our product candidates, including, for example, the manufacture of the antigens and ISS,
the component materials that are necessary for our product candidates, the combination of the
antigens and ISS, and the fill and finish. Termination or interruption of these
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relationships may
occur due to circumstances that are outside our control, resulting in higher cost or delays in our
product development efforts.
We and these third parties are required to comply with applicable current FDA good
manufacturing practice regulations and similar requirements in Canada and other foreign countries.
If one of these parties fails to maintain compliance with these
regulations, the production of our product candidates could be interrupted, resulting in
delays and additional costs. Additionally, these third parties must pass a pre-approval inspection
before we can obtain regulatory approval for any of our product candidates.
In particular, we have relied on a single supplier to produce our ISS for clinical trials. ISS
is a critical component of both of TOLAMBA and HEPLISAV. To date, we have manufactured only small
quantities of ISS ourselves for research purposes. If we were unable to maintain or replace our
existing source for ISS, we would have to establish an in-house ISS manufacturing capability,
incurring increased capital and operating costs and delays in developing and commercializing our
product candidates. We or other third parties may not be able to produce ISS at a cost, quantity
and quality that are available from our current third-party supplier.
In addition, we do not currently have a contract manufacturer for TOLAMBA or sufficient
TOLAMBA to supply our potential commercial needs. We are currently manufacturing supplies of
TOLAMBA for the second year of our current clinical trial in ragweed allergic children. We intend
to enter into manufacturing agreements with one or more commercial-scale contract manufacturers to
produce additional supplies of TOLAMBA as required for new clinical trials and commercialization.
If we are unable to complete such agreements, we may be unable to commence and complete our
clinical trials in a timely fashion, and we would have to establish an internal commercial scale
manufacturing capability for TOLAMBA, incurring increased capital and operating costs, delays in
the commercial development of TOLAMBA and higher manufacturing costs than we have experienced to
date.
We have or intend to contract with one or more third parties to conduct our clinical trials for
TOLAMBA and HEPLISAV. If these third parties do not carry out their contractual obligations or meet
expected deadlines, our planned clinical trials may be delayed and we may fail to obtain the
regulatory approvals necessary to commercialize TOLAMBA or HEPLISAV.
We are unable to independently conduct our planned clinical trials for TOLAMBA or HEPLISAV,
and we have or intend to contract with third party contract research organizations to manage and
conduct these trials. If these third parties do not carry out their contractual duties or
obligations or meet expected deadlines, if the third parties need to be replaced or if the quality
or accuracy of the clinical data they obtain is compromised due to failure to adhere to our
clinical protocols or for other reasons, our planned clinical trials may be extended, delayed or
terminated. Any extension, delay or termination of our trials would delay our ability to
commercialize TOLAMBA or HEPLISAV and generate revenues.
If any products we develop are not accepted by the market or if regulatory agencies limit our
labeling indications or marketing claims, we may be unable to generate significant revenues, if
any.
If we obtain regulatory approval for our product candidates and are able to successfully
commercialize them, our product candidates may not gain market acceptance among physicians,
patients, health care payors and the medical community. The FDA or other regulatory agencies could
limit the labeling indication for which our product candidates may be marketed or could otherwise
constrain our marketing claims, reducing our or our collaborators ability to market the benefits
of our products to particular patient populations. If we are unable to successfully market any
approved product candidates, or are limited in our marketing efforts by regulatory limits on
labeling indications or marketing claims, our ability to generate revenues could be significantly
impaired.
In particular, treatment with TOLAMBA, if approved, will require a series of injections, and
we expect that some of the patients that currently take oral or inhaled pharmaceutical products to
treat their allergies would not consider using our product. We believe that market acceptance of
TOLAMBA will also depend on our ability to offer competitive pricing, increased efficacy and
improved ease of use as compared to existing or potential new allergy treatments.
We may seek partners for purposes of commercialization of HEPLISAV in selected markets
worldwide. Marketing challenges vary by market and could limit or delay acceptance in any
particular country. We believe that market acceptance of HEPLISAV will depend on our ability to
offer increased efficacy and improved ease of use as compared to existing or potential new
hepatitis B vaccine products.
6
We face uncertainty related to coverage, pricing and reimbursement and the practices of third party
payors, which may make it difficult or impossible to sell our product candidates on commercially
reasonable terms.
In both domestic and foreign markets, our ability to generate revenues from the sales of any
approved product candidates in excess of the costs of producing the product candidates will depend
in part on the availability of reimbursement from third party payors. Existing laws affecting the
pricing and coverage of pharmaceuticals and other medical products by
government programs and other third party payors may change before any of our product
candidates are approved for marketing. In addition, third party payors are increasingly challenging
the price and cost-effectiveness of medical products and services. Significant uncertainty
therefore exists as to coverage and reimbursement levels for newly approved health care products,
including pharmaceuticals. Because we intend to offer products, if approved, that involve new
technologies and new approaches to treating disease, the willingness of third party payors to
reimburse for our products is particularly uncertain. We will have to charge a price for our
products that is sufficiently high to enable us to recover the considerable capital resources we
have spent and will continue to spend on product development. Adequate third-party reimbursement
may not be available to enable us to maintain price levels sufficient to realize a return on our
investment in product development. If it becomes apparent, due to changes in coverage or pricing of
pharmaceuticals in our market or a lack of reimbursement, that it will be difficult, if not
impossible, for us to generate revenues in excess of costs, we will need to alter our business
strategy significantly. This could result in significant unanticipated costs, harm our future
prospects and reduce our stock price.
Many of our competitors have greater financial resources and expertise than we do. If we are unable
to successfully compete with existing or potential competitors despite these disadvantages we may
be unable to generate revenues and our business will be harmed.
We compete with many companies and institutions, including pharmaceutical companies,
biotechnology companies, academic institutions and research organizations, in developing
alternative therapies to treat or prevent allergy, infectious diseases, asthma and cancer, as well
as those focusing more generally on the immune system. Competitors may develop more effective, more
affordable or more convenient products or may achieve earlier patent protection or
commercialization of their products. These competitive products may render our product candidates
obsolete or limit our ability to generate revenues from our product candidates. Many of the
companies developing competing technologies and products have significantly greater financial
resources and expertise in research and development, manufacturing, preclinical and clinical
testing, obtaining regulatory approvals and marketing than we do.
TOLAMBA, if approved, will compete directly with conventional allergy shots and indirectly
with antihistamines, corticosteroids and anti-leukotriene agents, used to treat seasonal allergy
symptoms, including those produced by GlaxoSmithKline Plc, Merck & Co., Inc., Novartis,
Schering-Plough and AstraZeneca Plc. Since our TOLAMBA ragweed allergy treatment would require a
series of injections, we expect that some patients that currently take oral or inhaled
pharmaceutical products to treat their allergies would not consider our product. HEPLISAV, if
approved, will compete with existing vaccines produced by GlaxoSmithKline Plc and Merck & Co.,
Inc., among others.
Existing and potential competitors may also compete with us for qualified scientific and
management personnel, as well as for technology that would be advantageous to our business. If we
are unable to compete with existing and potential competitors we may not be able to obtain
financing, sell our product candidates or generate revenues.
We depend on key employees in a competitive market for skilled personnel, and the loss of the
services of any of our key employees would affect our ability to develop and commercialize our
product candidates and achieve our objectives.
We are highly dependent on the principal members of our management, operations and scientific
staff, including our Chief Executive Officer, Dr. Dino Dina. We experience intense competition for
qualified personnel. Our future success also depends in part on the continued service of our
executive management team, key scientific and management personnel and our ability to recruit,
train and retain essential scientific personnel for our drug discovery and development programs,
including those who will be responsible for overseeing our preclinical testing and clinical trials
as well as for the establishment of collaborations with other companies. If we lose the services of
any of these people, our research and product development goals, including the identification and
establishment of key collaborations, operations and marketing efforts could be delayed or
curtailed.
7
We intend to develop, seek regulatory approval for and market our product candidates outside the
United States, requiring a significant commitment of resources. Failure to successfully manage our
international operations could result in significant unanticipated costs and delays in regulatory
approval or commercialization of HEPLISAV and therapeutic product candidates.
We plan to introduce HEPLISAV initially in various markets outside the United States.
Developing, seeking regulatory approval for and marketing our product candidates outside the United
States could impose substantial burdens on our resources and divert managements attention from
domestic operations. We may also conduct operations in other foreign jurisdictions.
International operations are subject to risk, including:
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the difficulty of managing geographically distant operations, including recruiting and retaining qualified employees,
locating adequate facilities and establishing useful business support relationships in the local community; |
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compliance with varying international regulatory requirements; |
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securing international distribution, marketing and sales capabilities; |
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adequate protection of our intellectual property rights; |
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difficulties and costs associated with complying with a wide variety of complex international laws and treaties; |
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legal uncertainties and potential timing delays associated with tariffs, export licenses and other trade barriers; |
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adverse tax consequences; |
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the fluctuation of conversion rates between foreign currencies and the U.S. dollar; and |
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geopolitical risks. |
If we are unable to successfully manage our international operations, we may incur significant
unanticipated costs and delays in regulatory approval or commercialization of HEPLISAV and
therapeutic product candidates, as well as other product candidates that we may choose to
commercialize internationally, which would impair our ability to generate revenues.
We recently acquired Rhein Biotech GmbH and any difficulties from integrating the Rheins business
into ours could disrupt our business and harm our financial condition.
On April 21, 2006, we acquired Rhein Biotech GmbH in a cash transaction of approximately $12.4
million, excluding certain employee and transaction related costs and expenses. Through this
acquisition, Dynavax gained ownership of a European Union (EU) GMP-certified vaccine manufacturing
facility in Düsseldorf, Germany, certain vaccine and other commercial programs, a management team
and personnel with specialized expertise in process development and vaccine manufacturing.
Integrating Rheins operations, technology and personnel with our operations and personnel is
a complex process. The successful integration of Dynavax and Rhein will require, among other
things, ongoing coordination of various integration efforts, relating to our personnel system,
technologies and commercial programs. We may not be able to rapidly or efficiently integrate
Rheins business and technology into ours and the expected benefits of the combination may not
materialize. Our ability to successfully integrate Rhein involves numerous risks, including:
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difficulties in integrating the operations, technologies, products and personnel of Rhein; |
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difficulties in successfully utilizing Rheins manufacturing capabilities to produce materials for our existing product
candidates in lieu of purchasing such materials from third party vendors; |
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diversion of managements attention from normal daily operations of the business; potential difficulties in
integrating different projects; |
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difficulties in entering markets in which we have no or limited direct prior experience and where competitors in such
markets have stronger market positions; |
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insufficient revenues to offset increased expenses associated with the acquisition; and potential loss of key
employees of Rhein. |
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The Rhein acquisition may also cause us to: |
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assume liabilities some of which may be unknown at of the time of such acquisitions; |
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record certain intangible assets in conjunction with our accounting for the transaction in the second quarter of 2006
that may be subject to immediate write-off, ongoing impairment testing, or potential periodic impairment charges, or
may cause us to incur future amortization expenses; |
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become subject to unknown litigation. |
There can be no assurance that we will be able to successfully integrate Rhein and its
technology and personnel into our business.
We use hazardous materials in our business. Any claims or liabilities relating to improper
handling, storage or disposal of these materials could be time consuming and costly to resolve.
Our research and product development activities involve the controlled storage, use and
disposal of hazardous and radioactive materials and biological waste. We are subject to federal,
state and local laws and regulations governing the use, manufacture, storage, handling and disposal
of these materials and certain waste products. We are currently in compliance with all government
permits that are required for the storage, use and disposal of these materials. However, we cannot
eliminate the risk of accidental contamination or injury to persons or property from these
materials. In the event of an accident related to hazardous materials, we could be held liable for
damages, cleanup costs or penalized with fines, and this liability could exceed the limits of our
insurance policies and exhaust our internal resources. We may have to incur significant costs to
comply with future environmental laws and regulations.
We face product liability exposure, which, if not covered by insurance, could result in significant
financial liability.
While we have not experienced any product liability claims to date, the use of any of our
product candidates in clinical trials and the sale of any approved products will subject us to
potential product liability claims and may raise questions about a products safety and efficacy.
As a result, we could experience a delay in our ability to commercialize one or more of our product
candidates or reduced sales of any approved product candidates. In addition, a product liability
claim may exceed the limits of our insurance policies and exhaust our internal resources. We have
obtained limited product liability insurance coverage in the amount of $1 million for each
occurrence for clinical trials with umbrella coverage of an additional $4 million. This coverage
may not be adequate or may not continue to be available in sufficient amounts, at an acceptable
cost or at all. We also may not be able to obtain commercially reasonable product liability
insurance for any product approved for marketing in the future. A product liability claim, product
recalls or other claims, as well as any claims for uninsured liabilities or in excess of insured
liabilities, would divert our managements attention from our business and could result in
significant financial liability.
If the combination of patents, trade secrets and contractual provisions that we rely on to protect
our intellectual property is inadequate, the value of our product candidates will decrease.
Our success depends on our ability to:
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obtain and protect commercially valuable patents or the rights to patents both domestically and abroad; |
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operate without infringing upon the proprietary rights of others; and |
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prevent others from successfully challenging or infringing our proprietary rights. |
We will be able to protect our proprietary rights from unauthorized use only to the extent
that these rights are covered by valid and enforceable patents or are effectively maintained as
trade secrets. We try to protect our proprietary rights by
9
filing and prosecuting United States and foreign patent applications. However, in certain
cases such protection may be limited, depending in part on existing patents held by third parties,
which may only allow us to obtain relatively narrow patent protection. In the United States, legal
standards relating to the validity and scope of patent claims in the biopharmaceutical field can be
highly uncertain, are still evolving and involve complex legal and factual questions for which
important legal principles remain unresolved.
The biopharmaceutical patent environment outside the United States is even more uncertain. We
may be particularly affected by this uncertainty, given that several of our product candidates may
initially address market opportunities outside the United States. For example, we expect to market
HEPLISAV, if approved, in various foreign countries with high incidences of hepatitis B, including
Canada, Europe and selected markets in Asia, where we may only be able to obtain limited patent
protection.
The risks and uncertainties that we face with respect to our patents and other proprietary
rights include the following:
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we might not have been the first to make the inventions covered by each of our pending patent applications and issued
patents; |
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we might not have been the first to file patent applications for these inventions; |
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the pending patent applications we have filed or to which we have exclusive rights may not result in issued patents or
may take longer than we expect to result in issued patents; |
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the claims of any patents that are issued may not provide meaningful protection; |
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our issued patents may not provide a basis for commercially viable products or may not be valid or enforceable; |
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we might not be able to develop additional proprietary technologies that are patentable; |
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the patents licensed or issued to us or our collaborators may not provide a competitive advantage; |
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patents issued to other companies, universities or research institutions may harm our ability to do business; |
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other companies, universities or research institutions may independently develop similar or alternative technologies or
duplicate our technologies and commercialize discoveries that we attempt to patent; and |
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other companies, universities or research institutions may design around technologies we have licensed, patented or
developed. |
We also rely on trade secret protection and confidentiality agreements to protect our
interests in proprietary know-how that is not patentable and for processes for which patents are
difficult to enforce. We cannot be certain that we will be able to protect our trade secrets
adequately. Any leak of confidential data into the public domain or to third parties could allow
our competitors to learn our trade secrets. If we are unable to adequately obtain or enforce
proprietary rights we may be unable to commercialize our products, enter into collaborations,
generate revenues or maintain any advantage we may have with respect to existing or potential
competitors.
We rely on our licenses from the Regents of the University of California. Impairment of these
licenses or our inability to maintain them would severely harm our business.
Our success depends upon our license arrangements with the Regents of the University of
California. These licenses are critical to our research and product development efforts. Our
dependence on these licenses subjects us to numerous risks, such as disputes regarding the
invention and corresponding ownership rights in inventions and know-how resulting from the joint
creation or use of intellectual property by us and the Regents of the University of California, or
scientific collaborators. Additionally, our agreements with the Regents of the University of
California generally contain diligence or milestone-based termination provisions. Our failure to
meet any obligations pursuant to these provisions could allow the Regents of the University of
California to terminate any of these licensing agreements or convert them to non-exclusive
licenses. In addition, our license agreements with the Regents of the University of California may
be terminated or may expire by their terms, and we may not be able to maintain the exclusivity of
these licenses. If we cannot maintain licenses that are
10
advantageous or necessary to the development or the commercialization of our product
candidates, we may be required to expend significant time and resources to develop or license
similar technology.
Our stock price is subject to volatility, and your investment may suffer a decline in value.
The market prices for securities of biopharmaceutical companies have in the past been, and are
likely to continue in the future to be, very volatile. The market price of our common stock is
subject to substantial volatility depending upon many factors, many of which are beyond our
control, including:
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progress or results of any of our clinical trials, in particular any announcements regarding the progress or results of
our planned trials for TOLAMBA and HEPLISAV; |
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progress of regulatory approval of our product candidates, in particular TOLAMBA and HEPLISAV, and compliance with
ongoing regulatory requirements; |
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our ability to establish collaborations for the development and commercialization of our product candidates; |
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market acceptance of our product candidates; |
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our ability to raise additional capital to fund our operations, whether through the issuance of equity securities or debt; |
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technological innovations, new commercial products or drug discovery efforts and preclinical and clinical activities by
us or our competitors; |
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changes in our intellectual property portfolio or developments or disputes concerning the proprietary rights of our
products or product candidates; |
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our ability to obtain component materials and successfully enter into manufacturing relationships for our product
candidates or establish manufacturing capacity on our own; |
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our ability to form strategic partnerships or joint ventures; |
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maintenance of our existing licensing agreements with the Regents of the University of California; |
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changes in government regulations; |
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issuance of new or changed securities analysts reports or recommendations; |
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general economic conditions and other external factors; |
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actual or anticipated fluctuations in our quarterly financial and operating results; and |
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degree of trading liquidity in our common stock |
One or more of these factors could cause a decline in the price of our common stock. In
addition, securities class action litigation has often been brought against a company following a
decline in the market price of its securities. This risk is especially relevant for us because we
have experienced greater than average stock price volatility, as have other biotechnology companies
in recent years. We may in the future be the target of similar litigation. Securities litigation
could result in substantial costs, and divert managements attention and resources, which could
harm our business, operating results and financial conditions.
11
Anti-takeover provisions of our certificate of incorporation, bylaws and Delaware law may prevent
or frustrate a change in control, even if an acquisition would be beneficial to our stockholders,
which could affect our stock price adversely and prevent attempts by our stockholders to replace or
remove our current management.
Provisions of our certificate of incorporation and bylaws may delay or prevent a change in
control, discourage bids at a premium over the market price of our common stock and adversely
affect the market price of our common stock and the voting or other rights of the holders of our
common stock. These provisions include:
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authorizing our Board of Directors to issue additional preferred stock with voting rights to be determined by the Board
of Directors; |
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limiting the persons who can call special meetings of stockholders; |
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prohibiting stockholder actions by written consent; |
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creating a classified board of directors pursuant to which our directors are elected for staggered three year terms; |
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providing that a supermajority vote of our stockholders is required for amendment to certain provisions of our
certificate of incorporation and bylaws; and |
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establishing advance notice requirements for nominations for election to our Board of Directors or for proposing
matters that can be acted on by stockholders at stockholder meetings. |
In addition, we are subject to the provisions of the Delaware corporation law that, in
general, prohibit any business combination with a beneficial owner of 15% or more of our common
stock for five years unless the holders acquisition of our stock was approved in advance by our
Board of Directors.
We will continue to implement additional finance and accounting systems, procedures or controls as
we grow our business and organization and to satisfy new reporting requirements.
As a public company, we are required to comply with the Sarbanes-Oxley Act of 2002 and the
related rules and regulations of the SEC, including expanded disclosures and accelerated reporting
requirements and more complex accounting rules. Compliance with Section 404 of the Sarbanes-Oxley
Act of 2002 and other requirements may increase our costs and require additional management
resources. We may need to continue to implement additional finance and accounting systems,
procedures and controls as we grow our business and organization and to comply with new reporting
requirements. There can be no assurance that we will be able to maintain a favorable assessment as
to the adequacy of our internal control reporting. If we are unable to maintain an unqualified
report as to the effectiveness of our internal controls over financial reporting, investors could
lose confidence in the reliability of our internal controls over financial reporting and the
reliability of our financial statements, which could harm our business and could impact the market
price of our common stock.
12
ABOUT THIS PROSPECTUS
This prospectus is part of a registration statement that we filed with the SEC to enable
selling stockholders, from time-to-time, to sell the securities described in this prospectus.
This prospectus provides you with a general description of the common stock that the selling
stockholders may offer. The information in this prospectus speaks as of the date of this prospectus
and may not reflect changes in our affairs. This prospectus may also be accompanied by a prospectus
supplement that may include additional risk factors or other special considerations, and may also
add, update or change information in this prospectus. If there is any inconsistency between the
information in this prospectus and any prospectus supplement, you should rely on the information in
that prospectus supplement. You should read both this prospectus and any prospectus supplement
together with the additional information described under the heading Additional Information.
When used in this prospectus, the terms Dynavax, we, our and us refer to Dynavax
Technologies Corporation and its consolidated subsidiaries, unless otherwise specified.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
The statements in this prospectus and the documents incorporated by reference contain
forward-looking statements which are subject to a number of risks and uncertainties. All statements
that are not historical facts are forward-looking statements, including statements about our
business strategy, our future research and development, our preclinical and clinical product
development efforts, the timing of the introduction of our products, the effect of GAAP accounting
pronouncements, uncertainty regarding our future operating results and our profitability,
anticipated sources of funds and all plans, objectives, expectations and intentions. These
statements appear in a number of places and can be identified by the use of forward-looking
terminology such as may, will, should, expect, plan, anticipate, believe, estimate,
predict, future, intend, or certain or the negative of these terms or other variations or
comparable terminology, or by discussions of strategy.
Our actual results may differ materially from the results expressed or implied by these
forward-looking statements because of the risk factors and other factors disclosed in this
prospectus and documents incorporated by reference. The risk factors may not be all of the factors
that could cause actual results to vary materially from the forward-looking statements. The
forward-looking statements made or incorporated in this prospectus relate only to circumstances as
of the date on which the statements are made. Readers should not place undue reliance on these
forward-looking statements and are cautioned that any such forward-looking statements are not
guarantees of future performance. We assume no obligation to update any forward-looking statements,
except as required by applicable law.
INCORPORATION OF DOCUMENTS BY REFERENCE
The SEC allows us to incorporate by reference the information contained in documents that we
file with them, which means that we can disclose important information to you by referring to those
documents. The information incorporated by reference is considered to be part of this prospectus.
Information in this prospectus modifies or supersedes information incorporated by reference that we
filed with the SEC prior to the date of this prospectus, and information that we file later with
the SEC also will automatically modify and supersede the information contained in, deemed to be a
part of, or incorporated by reference into this prospectus. We incorporate by reference the
documents listed below, any filings we will make with the SEC under Sections 13(a), 13(c), 14 or
15(d) of the Securities Exchange Act of 1934, as amended, after the date we filed the registration
statement of which this prospectus is a part and before the effective date of the registration
statement and any future filings we will make with the SEC under those sections.
The following documents filed with the SEC are incorporated by reference in this prospectus:
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Our Annual Report on Form 10-K for the year ended December 31, 2005, filed on March 16, 2006,
as amended on April 7, 2006; |
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Our quarterly report on Form 10-Q for the period ended March 31, 2006, filed on May 5, 2006; |
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Our Forms 8-K filed on March 15, 2006, April 24, 2006, April 27, 2006 and May 1, 2006; |
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The description of our common stock set forth in Registration Statement on Form S-1
(Registration No. 333-109965) filed with the SEC on February 5, 2004. |
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We will furnish without charge to you, on written or oral request, a copy of any or all of the
documents incorporated by reference, including exhibits to these documents. You should direct any
requests for documents to Jane M. Green, Ph.D., Vice President, Corporate Communications, 2929
Seventh Street, Suite 100, Berkeley, CA 94710-2753, (510) 848-5100.
USE OF PROCEEDS
We will not receive any proceeds from the sale of the shares of common stock by the selling
stockholders.
SELLING STOCKHOLDERS
On April 18, 2006 we issued a warrant to purchase 2,000,000 shares of our common stock to
Symphony Dynamo Holdings LLC in a transaction exempt from the registration requirements of the
Securities Act. Under the terms of the Symphony Dynamo Holdings LLC operating agreement and other
agreements related to the issuance of the warrant, Symphony Dynamo Holdings LLC is required to
distribute the warrant to its members in proportion to each members LLC interest, and one of those
members, Symphony Dynamo Investors LLC is in turn required to transfer the portion of the warrant
it receives to its members on a pro rata basis. All of these transactions are exempt from the
registration requirements of the Securities Act. When we refer to Symphony Dynamo Holdings LLC in
the table below, such reference also includes transferees of the warrant as described above. Upon
such distribution of the warrant, we will identify the transferees of the warrant as selling
stockholders in a prospectus supplement filed pursuant to Securities Act Rule 424(b)(7), as
permitted by Rule 430B(b). The selling stockholders, including their transferees, pledges or
donees or their successors, may from time to time offer and sell pursuant to this prospectus any or
all of the common stock owned by each of them.
The following table sets forth information with respect to the selling stockholder and the
shares of common stock beneficially owned by it that may be offered under this prospectus, assuming
exercise of the warrants held by the selling stockholder, without regard to any limitations on
exercise. The information is based on information provided by or on behalf of the selling
stockholder to us and is as of the date of this prospectus. Because the selling stockholder may
offer all or some portion of the common stock, no estimate can be given as to the amount of the
common stock that will be held by the selling stockholder upon termination of this offering. For
purposes of the table below, however, we have assumed that after termination of this offering none
of the shares covered by this prospectus will be held by the selling stockholder.
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Maximum Number of |
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Percent of |
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Number of Shares |
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Shares to be Sold |
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Name of Selling Stockholder |
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Symphony Dynamo Holdings LLC (1) |
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2,000,000 |
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2,000,000 |
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The managing member of Symphony Dynamo Holdings LLC is Symphony Capital Partners, L.P.,
which is controlled by Symphony Capital GP, L.P., its general partner, which is in turn
controlled by Symphony GP, LLC, its general partner. Symphony Capital LLC, as the investment
advisor of Symphony Capital Partners, L.P., maintains voting discretion and investment control
over these shares. The address for each is 875 Third Avenue, 18th Floor, New York,
New York, 10022. |
The selling stockholder received the warrants to purchase the common stock offered hereby as
part of a funding arrangement entered into on April 18, 2006 between it and us to advance the
development of programs for ISS compounds for cancer, hepatitis B and hepatitis C therapeutics.
Other than for this funding arrangement, neither the selling stockholder nor any of its affiliates,
officers, directors or principal equity holders has held any position or office or has had any
material relationship with us within the past three years. The selling stockholder is not a
broker-dealers or an affiliate of a broker-dealer.
PLAN OF DISTRIBUTION
We are registering the shares of common stock issuable upon exercise of the warrants to permit
the resale of these shares of common stock by the holders thereof from time to time after the date
of this prospectus. We will not receive any of the proceeds from the sale by the selling
stockholders of the shares of common stock. We will bear all fees and expenses incident to our
obligation to register the shares of common stock.
The selling stockholders may sell all or a portion of the shares of common stock beneficially
owned by them and offered hereby from time to time directly or through one or more underwriters,
broker-dealers or agents. If the shares of common stock are sold through underwriters or
broker-dealers, the selling stockholders will be responsible for underwriting
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discounts or commissions or agents commissions. We will file a prospectus supplement if the
selling stockholders engage one or more underwriters. The shares of common stock may be sold in one
or more transactions at fixed prices, at prevailing market prices at the time of the sale, at
varying prices determined at the time of sale, or at negotiated prices. These sales may be executed
in transactions, which may involve crosses or block transactions:
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on any national securities exchange or quotation service on which the securities may be listed or quoted at the time of
sale; |
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in the over-the-counter market; |
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in transactions otherwise than on these exchanges or systems or in the over-the-counter market; |
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through the writing of options, whether such options are listed on an options exchange or otherwise; |
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involving ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers; |
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involving block trades in which the broker-dealer 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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involving purchases by a broker-dealer as principal and resale by the broker-dealer for its account; |
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in an exchange distribution in accordance with the rules of the applicable exchange; |
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in privately negotiated transactions; |
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through the settlement of short sales; |
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where broker-dealers may agree with the selling stockholders to sell a specified number of such shares at a stipulated
price per share; |
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in a combination of any such methods of sale; and |
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through any other method permitted pursuant to applicable law. |
The selling stockholders may also sell shares under Rule 144 under the Securities Act, if
available, rather than under this prospectus, provided it meets the criteria and conform to the
requirements of such Rule.
If the selling stockholders effect such transactions by selling shares of common stock to or
through underwriters, broker-dealers or agents, such underwriters, broker-dealers or agents may
receive commissions in the form of discounts, concessions or commissions from the selling
stockholders or commissions from purchasers of the shares of common stock for whom they may act as
agent or to whom they may sell as principal (which discounts, concessions or commissions as to
particular underwriters, broker-dealers or agents may be in excess of those customary in the types
of transactions involved). In connection with sales of the shares of common stock or otherwise, the
selling stockholders may enter into hedging transactions with broker-dealers, which may in turn
engage in short sales of the shares of common stock in the course of hedging in positions they
assume. The selling stockholders may also sell shares of common stock short and deliver shares of
common stock covered by this prospectus to close out short positions. The selling stockholders may
also loan or pledge shares of common stock to broker-dealers that in turn may sell such shares.
The selling stockholders may pledge or grant a security interest in some or all of the
warrants or shares of common stock owned by them and, if they default in the performance of their
secured obligations, the pledgees or secured parties may offer and sell the shares of common stock
from time to time pursuant to this prospectus or any supplement to this prospectus under Rule 424
or other applicable provision of the Securities Act of 1933, as amended, modifying and superseding,
if necessary, the list of selling stockholders to include the pledgee, transferee or other
successors in interest as selling stockholders under this prospectus. The selling stockholders also
may transfer and donate the shares of common stock in other circumstances in which case the
transferees, donees, pledgees or other successors in interest will be the selling stockholders for
purposes of this prospectus. We will file a prospectus supplement naming the new selling
stockholders if the shares are transferred, donated or pledged.
15
The selling stockholders and any broker-dealer participating in the distribution of the shares
of common stock may be deemed to be underwriters within the meaning of the Securities Act, and
any commission paid, or any discounts or concessions allowed to, any such broker-dealer may be
deemed to be underwriting commissions or discounts under the Securities Act. At the time a
particular offering of the shares of common stock is made, a prospectus supplement, if required,
may be distributed which will set forth the aggregate amount of shares of common stock being
offered and the terms of the offering, including the name or names of any broker-dealers or agents,
any discounts, commissions and other terms constituting compensation from the selling stockholders
and any discounts, commissions or concessions allowed or reallowed or paid to broker-dealers.
Under the securities laws of some states, the shares of common stock may be sold in such
states only through registered or licensed brokers or dealers. In addition, in some states the
shares of common stock may not be sold unless such shares have been registered or qualified for
sale in such state or an exemption from registration or qualification is available and is complied
with.
The selling stockholders and any other person participating in such distribution will be
subject to applicable provisions of the Exchange Act and the rules and regulations thereunder,
including, without limitation, Regulation M of the Exchange Act, which may limit the timing of
purchases and sales of any of the shares of common stock by the selling stockholders and any other
participating person. Regulation M may also restrict the ability of any person engaged in the
distribution of the shares of common stock to engage in market-making activities with respect to
the shares of common stock. All of the foregoing may affect the marketability of the shares of
common stock and the ability of any person or entity to engage in market-making activities with
respect to the shares of common stock.
We will pay all expenses of the registration of the shares of common stock pursuant to a
registration rights agreement we entered into with the selling stockholders in connection with the
issuance of the warrants, including, without limitation, Securities and Exchange Commission filing
fees and expenses of compliance with state securities or blue sky laws; provided, however, that
the selling stockholders will pay all underwriting discounts and selling commissions, if any. We
will indemnify the selling stockholders against liabilities, including some liabilities under the
Securities Act, in accordance with the registration rights agreement, or the selling stockholders
will be entitled to contribution. We may be indemnified by the selling stockholders against civil
liabilities, including liabilities under the Securities Act, that may arise from any written
information furnished to us by the selling stockholders specifically for use in this prospectus, in
accordance with the registration rights agreement, or we may be entitled to contribution.
Once sold under the shelf registration statement, of which this prospectus forms a part, the
shares of common stock will be freely tradable in the hands of persons other than our affiliates.
16
LEGAL MATTERS
Morrison & Foerster LLP will pass upon the validity of the common stock offered by this
prospectus for us.
EXPERTS
The consolidated financial statements of Dynavax Technologies Corporation appearing in Dynavax
Technologies Corporations Annual Report (Form 10-K) for the year ended December 31, 2005, and
Dynavax Technologies Corporation managements assessment of the effectiveness of internal control
over financial reporting as of December 31, 2005 included therein, have been audited by Ernst &
Young LLP, independent registered public accounting firm, as set forth in their reports thereon,
included therein, and incorporated herein by reference. Such consolidated financial statements and
managements assessment are incorporated herein by reference in reliance upon such reports given on
the authority of such firm as experts in accounting and auditing
WHERE YOU CAN FIND MORE INFORMATION ABOUT DYNAVAX AND THIS OFFERING
We are a reporting company and we file annual, quarterly and current reports, proxy statements
and other information with the SEC. We have filed with the SEC a registration statement on Form S-3
under the Securities Act to register the shares of common stock offered by this prospectus.
However, this prospectus does not contain all of the information contained in the registration
statement and the exhibits and schedules to the registration statement. For further information
with respect to us and the securities offered under this prospectus, we refer you to the
registration statement and the exhibits and schedules filed as a part of the registration
statement. You may read and copy the registration statement, as well as our reports, proxy
statements and other information, at the SECs public reference room at 100 F Street, N.E.,
Washington, D.C. 20549. You can request copies of these documents by contacting the SEC and paying
a fee for the copying cost. Please call the SEC at 1-800-SEC-0330 for further information about the
operation of the public reference rooms. Our SEC filings are also available at the SECs website at
www.sec.gov. In addition, you can read and copy our SEC filings at the office of the National
Association of Securities Dealers, Inc. at 1735 K Street, N.W., Washington, D.C. 20006.
17
2,000,000 Shares
Common Stock
PROSPECTUS
, 2006
PART II
INFORMATION NOT REQUIRED IN THE PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution
The expenses to be paid by us in connection with the distribution of the securities being
registered are as set forth in the following table. All amounts shown are estimates except for the
Securities and Exchange Commission registration fee.
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SEC registration fee |
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$ |
935 |
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Legal fees and expenses |
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$ |
25,000 |
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Accounting fees and expenses |
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$ |
25,000 |
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Miscellaneous expenses |
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$ |
4,065 |
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Total |
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$ |
55,000 |
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Item 15. Indemnification of Directors and Officers
Under Section 145 of the General Corporation Law of Delaware (the Delaware Law), we have
broad powers to indemnify our directors and officers against liabilities they may incur in such
capacities, including liabilities under the Securities Act.
Our certificate of incorporation and bylaws include provisions to (i) eliminate the personal
liability of our directors for monetary damages resulting from breaches of their fiduciary duty to
the extent permitted by Delaware Law and (ii) require us to indemnify our directors and executive
officers to the fullest extent permitted by Delaware Law, including circumstances in which
indemnification is otherwise discretionary. Pursuant to Section 145 of the Delaware Law, a
corporation generally has the power to indemnify its present and former directors, officers,
employees and agents against expenses incurred by them in connection with any suit to which they
are, or are threatened to be made, a party by reason of their serving in such positions so long as
they acted in good faith and in a manner they reasonably believed to be in or not opposed to, the
best interests of the corporation and, with respect to any criminal action, had no reasonable cause
to believe their conduct was unlawful. We believe that these provisions are necessary to attract
and retain qualified persons as directors and executive officers. These provisions do not eliminate
the directors duty of care, and, in appropriate circumstances, equitable remedies such as
injunctive or other forms of non-monetary relief will remain available under Delaware Law. In
addition, each director will continue to be subject to liability for breach of the directors duty
of loyalty to us, for acts or omissions not in good faith or involving intentional misconduct, for
knowing violations of law, for acts or omissions that the director believes to be contrary to our
best interests or the best interests of our stockholders, for any transaction from which the
director derived an improper personal benefit, for acts or omissions involving a reckless disregard
for the directors duty to us or our stockholders when the director was aware or should have been
aware of a risk of serious injury to us or its stockholders, for acts or omissions that constitute
an unexcused pattern of inattention that amounts to an abdication of the directors duty to us or
our stockholders, for improper transactions between the director and us and for improper
distributions to stockholders and loans to directors and officers. The provision also does not
affect a directors responsibilities under any other law, such as the federal securities law or
state or federal environmental laws.
We have entered into indemnity agreements with our directors and certain of our executive
officers that require us to indemnify such persons against expenses, judgments, fines, settlements
and other amounts incurred (including expenses of a derivative action) in connection with any
proceeding, whether actual or threatened, to which any such person may be made a party by reason of
the fact that such person is or was one of our directors or executive officers, provided, among
other things, that such persons conduct was not knowingly fraudulent or deliberately dishonest or
constituted willful misconduct. The indemnification agreements also set forth certain procedures
that will apply in the event of a claim for indemnification thereunder.
At present, there is no pending litigation or proceeding involving any of our directors or
executive officers as to which indemnification is being sought nor are we aware of any threatened
litigation that may result in claims for indemnification by any executive officer or director.
II-1
We maintain an insurance policy covering our officers and directors with respect to certain
liabilities, including liabilities arising under the Securities Act or otherwise.
Item 16. Exhibits
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3.1 (1)
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Amended and Restated Certificate of Incorporation. |
3.2 (1)
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Amended and Restated Bylaws. |
4.1 (2)
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Form of Specimen Common Stock Certificate. |
5.1
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Opinion of Morrison & Foerster LLP. |
23.1
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Consent of independent registered public accounting firm. |
23.2
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Consent of Morrison & Foerster LLP (included in Exhibit 5.1). |
24.1
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Power of Attorney (included on the signature page hereto). |
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(1) |
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Incorporated by reference to Dynavax Technologies Corporations
Registration Statement (File No. 333-109965) on Form S-1 filed on
February 5, 2004. |
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(2) |
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Incorporated by reference to Dynavax Technologies Corporations
Registration Statement (File No. 333-109965) on Form S-1 filed on
January 16, 2004. |
Item 17. Undertakings
(a) The undersigned Registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being made of securities
registered hereby, a post-effective amendment to this registration statement:
(i) To include any prospectus required by Section 10(a)(3) of the Securities Act of 1933;
(ii) To reflect in the prospectus any facts or events arising after the effective date of
the registration statement (or the most recent post-effective amendment thereof) which,
individually or in the aggregate, represent a fundamental change in the information set forth in
the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of
securities offered (if the total dollar value of securities offered would not exceed that which was
registered) and any deviation from the low or high end of the estimated maximum offering range may
be reflected in the form of prospectus filed with the Securities and Exchange Commission pursuant
to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than a 20
percent 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 (i), (ii) and (iii) above do not
apply if the information required to be included in a post-effective amendment by those paragraphs
is contained in periodic reports filed with or furnished to the Securities and Exchange Commission
by the registrant pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934
that are incorporated by reference in this 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 of 1933,
each such post-effective amendment shall be deemed to be a new registration statement relating to
the securities offered herein, 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 of
1933 to any purchaser:
II-2
(A) 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
(B) 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 of 1933 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.
(b) The undersigned Registrant hereby undertakes that, for purposes of determining any
liability under the Securities Act of 1933, each filing of the registrants annual report pursuant
to Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934 (and, where applicable,
each filing of an employee benefit plans annual report pursuant to Section 15(d) of the Securities
Exchange Act of 1934) that is incorporated by reference in 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 of 1933 may be
permitted to directors, officers and controlling persons of the registrants pursuant to the
foregoing provisions, or otherwise, the registrants have been advised that in the opinion of the
Securities and Exchange Commission such indemnification is against public policy as expressed in
the Act and is, therefore, unenforceable. In the event that a claim for indemnification against
such liabilities (other than the payment by the registrant of expenses incurred or paid by a
director, officer or controlling person of the registrant in the successful defense of any action,
suit or proceeding) is asserted by such director, officer or controlling person in connection with
the securities being registered, the registrants will, unless in the opinion of their counsel the
matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the
question whether such indemnification by it is against public policy as expressed in the Act and
will be governed by the final adjudication of such issue.
II-3
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the Registrant 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 to be signed on its behalf by the undersigned,
thereunto duly authorized, in the City of Berkley, State of California, on June 2, 2006.
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DYNAVAX TECHNOLOGIES CORPORATION |
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By:
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/s/ DINO DINA, M.D. |
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Dino Dina, M.D. |
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President and Chief Executive Officer |
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes
and appoints Dino Dina, M.D. and Deborah A. Smeltzer, and each of them, as his or her true and
lawful attorneys-in-fact and agents, with full power of substitution and re-substitution, for him
or her and in his or her name, place and stead, in any and all capacities, to sign any and all
amendments (including post-effective amendments) to this Registration Statement, and to sign any
registration statement for the same offering covered by the Registration Statement that is to be
effective upon filing pursuant to Rule 462(b) promulgated under the Securities Act of 1933 and to
file the same, with all exhibits thereto, and other documents in connection therewith, with the
Securities and Exchange Commission, 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 and
necessary to be done in connection therewith and about the premises, as fully to all intents and
purposes as he or she might or could do in person, hereby ratifying and confirming all that said
attorneys-in-fact and agents, or any of them, or their, his or her substitute or substitutes, may
lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Act of 1933, this Registration Statement has
been signed by the following persons in the capacities and on the dates indicated:
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Signature |
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Title |
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Date |
/s/ Dino Dina, M.D.
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President, Chief Executive Officer and Director
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June 2, 2006 |
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Dino Dina, M.D.
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(Principal Executive Officer) |
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/s/ Deborah A. Smeltzer
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Vice President, Operations and Chief Financial Officer
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June 2, 2006 |
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Deborah A. Smeltzer
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(Principal Financial Officer) |
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/s/ Timothy G. Henn
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Vice President, Finance & Administration and Chief
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June 2, 2006 |
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Timothy G. Henn
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Accounting Officer |
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(Principal Accounting Officer) |
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/s/ Arnold Oronsky, Ph.D.
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Chairman of the Board
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June 2, 2006 |
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Arnold Oronsky, Ph.D. |
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/s/ Nancy L. Buc
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Director
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June 2, 2006 |
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Nancy L. Buc |
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/s/ Dennis Carson, M.D.
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Director
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June 2, 2006 |
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Dennis Carson, M.D. |
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/s/ Daniel S. Janney
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Director
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June 2, 2006 |
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Daniel S. Janney |
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Director
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Denise M. Gilbert, Ph.D. |
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II-4
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Signature |
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Title |
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Date |
/s/ Jan Leschly
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Director
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June 2, 2006 |
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Jan Leschly |
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Director
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Stanley A. Plotkin, M.D. |
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II-5
INDEX TO EXHIBITS
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3.1 (1)
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Amended and Restated Certificate of Incorporation. |
3.2 (1)
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Amended and Restated Bylaws. |
4.1 (2)
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Form of Specimen Common Stock Certificate. |
5.1
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Opinion of Morrison & Foerster LLP. |
23.1
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Consent of independent registered public accounting firm. |
23.2
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Consent of Morrison & Foerster LLP (included in Exhibit 5.1). |
24.1
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Power of Attorney (included on the signature page hereto). |
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|
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(1) |
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Incorporated by reference to Dynavax Technologies Corporations
Registration Statement (File No. 333-109965) on Form S-1 filed on
February 5, 2004. |
|
(2) |
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Incorporated by reference to Dynavax Technologies Corporations
Registration Statement (File No. 333-109965) on Form S-1 filed on
January 16, 2004. |
II-6