S-3
As filed with the Securities and Exchange Commission on May 16, 2008
Registration No. 333-
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM S-3
REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933
DUSA PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Its Charter)
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New Jersey
(State or Other Jurisdiction
of Incorporation or Organization)
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22-3103129
(I.R.S. Employer
Identification No.) |
25 Upton Drive
Wilmington, Massachusetts 01887
(978) 657-7500
(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrants Principal Executive Offices)
Robert F. Doman, President and CEO
DUSA Pharmaceuticals, Inc.
25 Upton Drive
Wilmington, Massachusetts 01887
(978) 657-7500
(Address, Including Zip Code, and Telephone Number, Including Area Code, of Agent For Service)
Copies to:
Nanette W. Mantell, Esq.
Reed Smith LLP
136 Main Street Suite 250
Princeton, New Jersey 08543-7839
(609) 987-0050
Approximate date of commencement of proposed sale to the public: From time to time after the
effective date of this Registration Statement.
If the only securities being registered on this Form are being offered pursuant to dividend or
interest reinvestment plans, please check the following box. o
If any of the securities being registered on this Form are to be offered on a delayed or continuous
basis pursuant to Rule 415 under the Securities Act of 1933, other than securities offered only in
connection with dividend or interest reinvestment plans, check the following
box. þ
If this Form is filed to register additional securities for an offering pursuant to Rule 462(b)
under the Securities Act, please check the following box and list the Securities Act registration
statement number of the earlier effective registration statement for the same offering. o
If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act,
check the following box and list the Securities Act registration statement number of the earlier
effective registration statement for the same offering. o
If this Form is a Registration Statement pursuant to General Instruction I.D. or a post-effective
amendment thereto that shall become effective upon filing with the Commission pursuant to Rule
462(e) under the Securities Act, check the following box. o
If this Form is a post-effective amendment to a Registration Statement filed pursuant to General
Instruction I.D. to register additional securities or classes of securities pursuant to Rule 413(b)
under the Securities Act, check the following box. o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated
filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act
(Check one):
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Large accelerated filer o |
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Accelerated filer þ |
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Non-accelerated filer o |
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Smaller reporting company o |
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(Do not check if a smaller reporting company) |
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CALCULATION OF REGISTRATION FEE
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Proposed |
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Proposed |
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Maximum |
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Maximum |
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TITLE OF EACH CLASS |
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Aggregate |
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Aggregate |
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Amount of |
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OF SECURITIES TO BE |
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Amount to be |
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Offering Price |
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Offering Price |
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Registration |
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REGISTERED |
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Registered (2) |
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Per Share (2) |
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(3)(4)(5) |
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Fee (6) |
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Common Stock,
without par value
(1), Preferred
Stock, Debt
Securities,
Depository Shares
and Warrants |
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Total |
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$ N/A |
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$ N/A |
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$75,000,000 |
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$2,947.50 |
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(1) |
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This registration statement also relates to rights to purchase one one-thousandth
(1/1000th) of a share of Series A Junior Participating Preferred Stock, without par value,
which are attached to all shares of the registrants common stock pursuant to the Rights
Agreement dated as of September 27, 2002, between the registrant and American Stock Transfer
and Trust Company. Until the occurrence of events described in the Rights Agreement, the
rights are not exercisable, are evidenced by the registrants common stock certificates and
are transferable with and only with the registrants common stock. |
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(2) |
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Omitted pursuant to General Instruction II.D of Form S-3 under the Securities Act. |
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(3) |
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There is being registered hereunder such number of shares of common stock and preferred stock
and such number of debt securities, depositary shares and warrants as will result in aggregate
proceeds of $75,000,000 (or the equivalent thereof in one or more foreign currencies, foreign
currency units or composite currencies); or, if any debt securities are issued at an original
issue discount, such greater amount as shall result in net proceeds of $75,000,000 (or the
equivalent thereof in one or more foreign currencies, foreign currency units or composite
currencies) to the registrant. |
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(4) |
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Pursuant to Rule 416 under the Securities Act of 1933, as amended, this registration
statement also covers any additional securities that may become issuable pursuant to stock
splits, stock dividends or similar transactions, without the need for any post-effective
amendment. There are also being registered hereunder an indeterminate number of shares of
common stock and preferred stock, and an indeterminate principal amount of debt securities, in
each case issuable upon conversion, exchange or exercise of the preferred stock, debt
securities or warrants registered hereunder. No separate consideration will be received for
the preferred stock or common stock issuable upon conversion of or in exchange for debt
securities or preferred stock. |
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(5) |
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This amount is estimated solely for the purpose of calculating the registration pursuant to
Rule 457(o) under the Securities Act of 1933, as amended. Rule 457(o) permits the
registration fee to be calculated on the basis of the maximum offering price of all of the
securities listed and, therefore, the table does not specify by each class information as to
the amount to be registered, the maximum offering price per unit or the proposed maximum
aggregate offering price. The proposed maximum offering price per unit will be determined
from time to time in connection with the issuance of securities registered hereunder. |
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(6) |
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Calculated pursuant to Rule 457(o) under the Securities Act. |
The registrant hereby amends this registration statement on such date or dates as may be necessary
to delay its effective date until the registrant shall file a further amendment which specifically
states that this registration statement shall thereafter become effective in accordance with
Section 8(a) of the Securities Act of 1933 or until the registration statement shall become
effective on such date as the Commission, acting pursuant to said Section 8(a), may determine.
The information in this prospectus is not complete and may be changed. We may not sell
these securities until the registration statement filed with the Securities and
Exchange Commission is effective. This prospectus is not an offer to sell these
securities and it is not soliciting an offer to buy these securities in any state
where the offer or sale is not permitted.
Prospectus
Subject to Completion, Dated May 16, 2008
$75,000,000
DUSA PHARMACEUTICALS, INC.
Common Stock, Preferred Stock, Debt Securities,
Depositary Shares and Warrants
This prospectus relates to the public offer and sale of common stock, preferred
stock, debt securities, depositary shares, and warrants which we may offer from time
to time in one or more series, with an aggregate public offering price of up to
$75,000,000. We may offer and sell the securities separately, together or as units,
in separate classes or series, in amounts, at prices and on terms to be determined at
the time of sale.
Each time we sell securities, we will provide a prospectus supplement that will
contain specific information about the terms of that offering. The prospectus
supplement may also add, update or change information contained in this prospectus.
You should read both this prospectus and any prospectus supplement together with
additional information described under the heading Where You Can Find More
Information before you make your investment decision.
We may offer the securities from time to time through public or private
transactions, directly or through underwriters, agents or dealers and in the case of
our common stock, on or off the Nasdaq Global Market, at prevailing market prices or
at privately negotiated prices. For additional information on the methods of sale,
you should refer to the section entitled Plan of Distribution in this prospectus and
in the applicable prospectus supplement. If any underwriters, agents, or dealers are
involved in the sale of any of these securities, the applicable prospectus supplement
will set forth the names of the underwriter, agent, or dealer and any applicable fees,
commissions, or discounts. The supplements to this prospectus will designate the
terms of our plan of distribution.
This prospectus may not be used to offer or sell any securities unless
accompanied by a prospectus supplement.
Our common stock is traded on the NASDAQ Global Market under the symbol DUSA.
The last reported sale price of our common stock on May 14, 2008 was $2.22 per
share.
Based on the last reported sale price of our common stock on the NASDAQ Global
Market on April 2, 2008 ($2.57), the aggregate market value of our outstanding common
stock held by non-affiliates was approximately $61,317,571. As of the date hereof, we
have not offered any securities pursuant to General Instruction I.B.6 of Form S-3
during the prior 12 calendar month period that ends on and includes the date hereof.
Investing in our securities involves a high degree of risk.
See Risk Factors beginning on page 3.
Neither the Securities and Exchange Commission nor any state securities
commission has approved or disapproved of these securities or passed upon the adequacy
or accuracy of this prospectus. Any representation to the contrary is a criminal
offense.
The date of this prospectus is , 2008
TABLE OF CONTENTS
ABOUT THIS PROSPECTUS
This prospectus is part of a shelf registration statement that we filed with the United
States Securities and Exchange Commission, or the SEC. By using a shelf registration statement, we
may sell any combination of the securities described in this prospectus from time to time in one or
more offerings. We may use this prospectus to offer and sell up to a total of $75,000,000 of our
securities. This prospectus only provides you with a general description of the securities we may
offer. Each time we sell securities, we will provide a supplement to this prospectus that contains
specific information about the terms of the securities offered. The supplement may also add,
update or change information contained in this prospectus.
The registration statement that contains this prospectus, including the exhibits to the
registration statement and the information incorporated by reference into the registration
statement, contains additional information about the securities offered under this prospectus.
That registration statement can be read at the SECs website or at the SEC offices mentioned below
under the heading Where You Can Find More Information found on page 37. Before purchasing any
securities, you should carefully read both this prospectus and any supplement, together with the
additional information described under the heading Incorporation of Certain Documents by
Reference found on page 38.
You should rely only on the information contained or incorporated by reference in this
prospectus or any supplement. We have not authorized anyone to provide you with information
different from that which is contained in or incorporated by reference to this prospectus. We are
offering to sell securities only in jurisdictions where offers and sales are permitted. The
information contained in this prospectus is accurate only as of the date of this prospectus,
regardless of the time of delivery of this prospectus or of any sale of the securities.
We will not use this prospectus to offer and sell securities unless it is accompanied by a
supplement that more fully describes the securities being offered and the terms of the offering.
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DUSA PHARMACEUTICALS, INC.
About DUSA
DUSA is a vertically integrated dermatology company that is developing and marketing
Levulan® PDT and other products for common skin conditions. Our currently marketed
products include among others Levulan® Kerastick® 20% Topical Solution with
photodynamic therapy, the BLU-U® brand light source, certain products acquired in the
March 10, 2006 merger with Sirius Laboratories, Inc., including, Nicomide® and
ClindaReach.
Historically, we devoted most of our resources to advancing the development and marketing of
our Levulan® PDT/PD technology platform. In addition to our marketed products, our drug,
Levulan® brand of aminolevulinic acid HCl, or ALA, in combination with light, has been
studied in a broad range of medical conditions. When Levulan® is used and followed with
exposure to light to treat a medical condition, it is known as Levulan® PDT. When
Levulan® is used and followed with exposure to light to detect medical conditions, it is
known as Levulan® photodetection, or Levulan® PD. Our Kerastick®
is the proprietary applicator that delivers Levulan®.
The Levulan® Kerastick® 20% Topical Solution with PDT and the
BLU-U® brand light source were launched in the United States, or U.S., in September 2000
for the treatment of non-hyperkeratotic actinic keratoses, or AKs, of the face or scalp under a
former dermatology collaboration. AKs are precancerous skin lesions caused by chronic sun exposure
that can develop over time into a form of skin cancer called squamous cell carcinoma. In addition,
in September 2003 we received clearance from the United States Food and Drug Administration, or
FDA, to market the BLU-U® without Levulan® PDT for the treatment of moderate
inflammatory acne vulgaris and general dermatological conditions.
Sirius Laboratories, Inc., or Sirius, a dermatology specialty pharmaceuticals company, was
founded in 2000 with a primary focus on the treatment of acne vulgaris and acne rosacea.
Nicomide®, its key product, is an oral prescription vitamin supplement which targets the
market for inflammatory skin conditions such as acne. The merger has allowed us to expand our
product portfolio, capitalize on cross-selling and marketing opportunities, increase our sales
force size, as well as provide a pipeline of potential new products, including ClindaReach which
was launched in March 2007.
We are responsible for manufacturing of our Levulan® Kerastick® and for
the regulatory, sales, marketing, and customer service of our Levulan®
Kerastick®, and other related product activities for all of our products. Our current
objectives include increasing the sales of our products in the United States, Canada, Latin America
and Korea, launching Levulan® with our partners in additional Latin American countries
and Asia, continuing our efforts of exploring partnership opportunities for Levulan® PDT
for dermatology in Europe and Japan and continuing our Levulan® PDT clinical development
program for the moderate to severe acne indication.
To further these objectives, we entered into a marketing and distribution agreement with
Stiefel Laboratories, Inc. in January 2006 granting Stiefel an exclusive right to distribute the
Levulan® Kerastick® in Mexico, Central and South America. On March 5, 2008,
Stiefel notified us that the Brazilian authorities had published the final pricing for the product
which is acceptable to Stiefel and to us. Stiefel launched the product in Brazil in April 2008.
The product was launched in Argentina, Chile, Colombia and Mexico during the fourth quarter of
2007. Similarly, in January 2007, we entered into a marketing and distribution agreement with
Daewoong Pharmaceutical Co., Ltd. and Daewoongs wholly owned subsidiary, DNC Daewoong Derma &
Plastic Surgery Network Company, together referred to as Daewoong, granting Daewoong exclusive
rights to distribute the Levulan® Kerastick® in certain Asian countries. In
the fourth quarter of 2007, the Korean Food and Drug Administration, approved Levulan®
Kerastick® for PDT for the treatment of actinic keratosis, and Daewoong launched our
product in Korea.
We believe that issues related to reimbursement negatively impacted the economic
competitiveness of our therapy with other AK therapies and hindered its adoption in the past.
Though we believe that current Centers for Medicare and Medicaid Services reimbursement levels
allow us to be competitive, we continue to support efforts to improve reimbursement levels to
physicians. Most major private insurers have approved coverage for our AK
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therapy, however some private insurers still do not provide adequate coverage. When we learn of
these issues, we educate the insurers and are often able to facilitate a change in their coverage
policy. We believe that with potential future improvements, along with our education and marketing
programs, a more widespread adoption of our therapy should occur over time.
We are developing Levulan® PDT and PD under an exclusive worldwide license of
patents and technology from PARTEQ Research and Development Innovations, the licensing arm of
Queens University, Kingston, Ontario, Canada. We also own or license certain other patents
relating to methods for using pharmaceutical formulations which contain our drug and related
processes and improvements. In the United States, DUSA®, DUSA Pharmaceuticals, Inc.®,
Levulan®, Kerastick®, BLU-U® Nicomide®,
Nicomide-T®, Meted®, Psoriacap® and Psoriatec® are
registered trademarks. Several of these trademarks are also registered in Europe, Australia,
Canada, and in other parts of the world. Numerous other trademark applications are pending.
As of March 31, 2008, we had an accumulated deficit of approximately $136,900,000. We cannot
predict whether any of our products will achieve significant enough market acceptance or generate
sufficient revenues to enable us to become profitable on a sustainable basis. We expect to
continue to incur operating losses until sales of our products increase substantially. Achieving
our goal of becoming a profitable operating company is dependent upon greater acceptance of our PDT
therapy by the medical and consumer constituencies, increased sales of our products and other
factors contained in this report and in the filings we make with the Securities and Exchange
Commission, or SEC.
As of March 31, 2008, we had a staff of 90 employees, including 4 part-time employees, as
compared to 85 full-time employees, including 2 part-time employees at the end of 2006, who worked
across all operating functions at DUSA.
We were incorporated on February 21, 1991, under the laws of the State of New Jersey. Our
principal executive offices are located at 25 Upton Drive, Wilmington, Massachusetts 01887, and our
telephone number is (978) 657-7500. Unless the context otherwise requires, the terms we, our,
us and DUSA refer to DUSA Pharmaceuticals, Inc., a New Jersey corporation.
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RISK FACTORS
Investing in our securities is very speculative and involves a high degree of risk. You should
carefully consider and evaluate all of the information in, or incorporated by reference in, this
prospectus. The following are among the risks we face related to our business, assets and
operations. They are not the only ones we face. Any of these risks could materially and adversely
affect our business, results of operations and financial condition, which in turn could materially
and adversely affect the trading price of our common stock and you might lose all or part of your
investment.
This prospectus contains forward-looking statements that involve risks and uncertainties, such
as statements of our plans, objectives, expectations and intentions. We use words such as
anticipate, believe, expect, future, and intend and similar expressions to identify
forward-looking statements. Our actual results could differ materially from those anticipated in
these forward-looking statements for many reasons, including the factors described below and
elsewhere in this prospectus. You should not place undue reliance on these forward-looking
statements, which apply only as of the date of this prospectus.
Risks Related To DUSA
We Are Not Currently Profitable And May Not Be Profitable In The Future Unless We Can Successfully
Market And Sell Significantly Higher Quantities Of Our Products.
If Product Sales Do Not Increase Significantly, We May Not Be Able To Advance Development Of Our
Other Potential Products As Quickly As We Would Like To, Which Would Delay The Approval Process
And Marketing Of New Potential Products.
If we do not generate sufficient revenues from our approved products, we may be forced to
delay or abandon some or all of our product development programs. The pharmaceutical development
and commercialization process is time consuming and costly, and any delays might result in higher
costs which could adversely affect our financial condition. Without sufficient product sales, we
would need alternative sources of funding. There is no guarantee that adequate funding sources
could be found to continue the development of all our potential products. We might be required to
commit substantially greater capital than we have available to research and development of such
products and we may not have sufficient funds to complete all or any of our development programs,
including our acne program.
Nicomide® Will Likely Lose Significant Market Share If Another Generic Product Enters
the Market And Our Ability To Become Profitable Will Be More Difficult.
In March 2006, we acquired Nicomide® in connection with our merger with Sirius
Laboratories, Inc. Shortly after the closing of the merger, we became engaged in patent litigation
with Rivers Edge Pharmaceuticals, LLC, or Rivers Edge, a company that launched a
niacinamide-based product in competition with our Nicomide® product. Rivers Edge had
also requested that the United States Patent and Trademark Office reexamine the
Nicomide® patent claiming that it is invalid. Nicomide® sales were adversely
impacted throughout the litigation process and had a material negative impact on our revenues,
results of operations and liquidity. On October 28, 2007, we entered into a settlement agreement
and mutual release, or settlement agreement, to dismiss the lawsuit. On March 6, 2008, the USPTO
vacated the reexamination.
We are aware that another manufacturer has listed a niacinamide product in various drug
databases as a substitute for Nicomide® and have been informed that other companies may
be making plans to launch a substitutable niacinamide product. If that should occur, our revenues
from sales of Nicomide® will decrease, perhaps permanently, and our ability to become
profitable will be more difficult.
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Any Failure To Comply With Ongoing Governmental Regulations In The United States And Elsewhere
Will Limit Our Ability To Market Our Products and Become Profitable.
The manufacture and marketing of our products are subject to continuing FDA review as well as
comprehensive regulation by the FDA and by state and local regulatory authorities. These laws
require, among other things:
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approval of manufacturing facilities, including adherence to good manufacturing
and laboratory practices during production and storage, |
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controlled research and testing of some of these products even after approval,
and |
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control of marketing activities, including advertising and labeling. |
If we, or any of our contract manufacturers, fail to comply with these requirements, we may be
limited in the jurisdictions in which we are permitted to sell our products. Additionally, if we or
our manufacturers fail to comply with applicable regulatory approval requirements, a regulatory
agency may also:
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send warning letters, as recently received by the manufacturer of our
BLU-U®, |
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impose fines and other civil penalties on us, |
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seize our products, |
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suspend our regulatory approvals, |
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cease the manufacture of our products, as Actavis Totowa is doing with
Nicomide®, |
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refuse to approve pending applications or supplements to approved applications
filed by us, |
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refuse to permit exports of our products from the United States, |
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require us to recall products, |
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require us to notify physicians of labeling changes and/or product related
problems, |
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impose restrictions on our operations, and/or |
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criminally prosecute us. |
We and our manufacturers must continue to comply with cGMP and Quality System Regulation, or QSR,
and equivalent foreign regulatory requirements. The cGMP requirements govern quality control and
documentation policies and procedures. In complying with cGMP and foreign regulatory requirements,
we and our third-party manufacturers will be obligated to expend time, money and effort in
production, record keeping and quality control to assure that our products meet applicable
specifications and other requirements.
Certain of the products acquired in connection with the Sirius merger must meet certain
minimum manufacturing and labeling standards established by the FDA and applicable to products
marketed without approved marketing applications including Nicomide®. The FDA regulates
such products under its marketed unapproved drugs compliance policy guide entitled, Marketed New
Drugs without Approved NDAs or ANDAs. Under this policy, the FDA recognizes that certain
unapproved products, based on the introduction date of their active ingredients and the lack of
safety concerns, have been marketed for many years and, at this time, will not be the subject of
any enforcement action. The FDA has recently taken a more proactive role and is strongly
encouraging manufacturers of such products to submit applications to obtain marketing approval and
we have begun discussions with the FDA to begin that process. The FDAs enforcement discretion
policy does not apply to drugs or firms that may be in violation of regulatory requirements other
than preapproval submission requirements and the FDA may
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bring an action against a drug or a firm when the FDA concludes that such other violations
exist. The contract manufacturer of Nicomide® has received notice that the FDA considers
prescription dietary supplements to be unapproved new drugs that are misbranded and that cannot be
legally marketed, and has received notice that the FDA believes Nicomide® could not be
marketed as a dietary supplement with its current labeling. In April 2008, our contract
manufacturer of Nicomide® informed us that they will cease manufacturing
Nicomide® due to their continuing discussions with the U.S. Food and Drug
Administration. We have inventory supplies of Nicomide®, either in the distribution
channel or at wholesalers, to last approximately 6 months at current sales levels. We are
evaluating alternative manufacturing, labeling and distribution strategies in order to maintain
Nicomide® on the market, but we could experience a back-order situation if a replacement
manufacturer is not available in time to meet our supply needs. We may be required to make certain
labeling changes and market Nicomide® as an over-the-counter product or as a dietary
supplement under applicable legislation, or withdraw the product from the market, unless and until
we submit a marketing application and obtain FDA marketing approval. Action by the FDA could have a
material impact on our Non-PDT Drug Product revenues. Label changes eliminating claims of certain
medicinal benefits would make it more difficult to market these products and could therefore,
negatively affect our revenues and profits.
Manufacturing facilities are subject to ongoing periodic inspection by the FDA, including
unannounced inspections. We cannot guarantee that our third-party supply sources, or our own
Kerastick® facility, will continue to meet all applicable FDA regulations. If we, or any
of our manufacturers, including without limitation, the manufacturer of the BLU-U®, who
has received warning letters from the FDA, fail to maintain compliance with FDA regulatory
requirements, it would be time consuming and costly to remedy the problem(s) or to qualify other
sources. These consequences could have a significant adverse effect on our financial condition and
operations. As part of our FDA approval for the Levulan® Kerastick® for AK, we were
required to conduct two Phase IV follow-up studies. We successfully completed the first study; and
submitted our final report on the second study to the FDA in January 2004. The FDA could request
additional information and/or studies. Additionally, if previously unknown problems with the
product, a manufacturer or its facility are discovered in the future, changes in product labeling
restrictions or withdrawal of the product from the market may occur. Any such problems could affect
our ability to become profitable.
Patent Litigation Is Expensive And We May Not Be Able To Afford The Costs.
The costs of litigation or any proceeding relating to our intellectual property rights could
be substantial even if resolved in our favor. Some of our competitors have far greater resources
than we do and may be better able to afford the costs of complex patent litigation. For example,
third-parties may infringe one or more of our patents, and cause us to spend significant resources
to enforce our patent rights. Also, in a lawsuit against a third-party for infringement of our
patents in the United States, that third-party may challenge the validity of our patent(s). We
cannot guarantee that a third-party will not claim, with or without merit, that our patents are not
valid or that we have infringed their patent(s) or misappropriated their proprietary material.
Defending these types of legal actions involve considerable expense and could negatively affect our
financial results.
Additionally, if a third-party were to file a United States patent application in the United
States, or be issued a patent claiming technology also claimed by us in a pending United States
application(s), we may be required to participate in interference proceedings in the United States
Patent and Trademark Office to determine the priority of the invention. A third-party could also
request the declaration of a patent interference between one of our issued United States patents
and one of its patent applications. Any interference proceedings likely would require participation
by us and/or PARTEQ, could involve substantial legal fees and result in a loss or lessening of our
patent protection.
If We Are Unable To Obtain The Necessary Capital To Fund Our Operations, We Will Have To Delay Our
Development Programs And May Not Be Able To Complete Our Clinical Trials.
While we recently completed a private placement raising net proceeds of approximately $10.3
million in October 2007, we may need substantial additional funds to fully develop, manufacture,
market and sell our other potential products. We may obtain funds through other public or private
financings, including equity financing, and/or through collaborative arrangements. We cannot
predict whether any additional financing will be available at
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all or on acceptable terms. Depending on the extent of available funding, we may delay, reduce
in scope or eliminate some of our research and development programs. We may also choose to license
rights to third parties to commercialize products or technologies that we would otherwise have
attempted to develop and commercialize on our own which could reduce our potential revenues.
The availability of additional capital to us is uncertain. There can be no assurance that
additional funding will be available to us on favorable terms, if at all. Any equity financing, if
needed, would likely result in dilution to our existing shareholders and debt financing, if
available, would likely involve significant cash payment obligations and include restrictive
covenants that restrict our ability to operate our business. Failure to raise capital if needed
could materially adversely impact our business, our financial condition, results of operations and
cash flows.
Since We Now Operate The Only FDA Approved Manufacturing Facility For The Kerastick® And
Continue To Rely Heavily On Sole Suppliers For The Manufacture Of Levulan®, The
BLU-U®, Nicomide
®
, Meted®
, Psoriacap® And
Psoriatec ®, Any Supply Or Manufacturing Problems Could Negatively Impact Our Sales.
If we experience problems producing Levulan® Kerastick® units in our
facility, or if any of our contract suppliers fail to supply our requirements for products, our
business, financial condition and results of operations would suffer. Although we have received
approval by the FDA to manufacture the BLU-U® and the Levulan®
Kerastick® in our Wilmington, Massachusetts facility, at this time, with respect to the
BLU-U®, we expect to utilize our own facility only as a back-up to our current third
party manufacturer or for repairs unless we decide to manufacture in light of FDAs warning letter
to our BLU-U® manufacturer.
Nicomide® is the key product we acquired from Sirius in connection with our merger completed
in March, 2006. Nicomide® is an oral prescription vitamin supplement. The FDA has notified the
manufacturer that the FDA believes that Nicomide® could not be marketed as a dietary
supplement with its current labeling. The FDA regulates such products under the compliance policy
guide described above entitled, Marketed New Drugs without Approved NDAs or ANDAs. In April
2008, we were notified by our contract manufacturer of Nicomide® that they will cease manufacturing
Nicomide® due to their continuing discussions with the U.S. Food and Drug Administration. We have
inventory supplies of Nicomide®, either in the distribution channel or at wholesalers, to last
approximately 6 months at current sales levels. We are evaluating alternative manufacturing,
labeling and distribution strategies in order to maintain Nicomide® on the market, but we could
experience a back-order situation if a replacement manufacturer is not available in time to meet
our supply needs.
Manufacturers and their subcontractors often encounter difficulties when commercial quantities
of products are manufactured for the first time, or large quantities of products are manufactured,
including problems involving:
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product yields, |
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quality control, |
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component and service availability, |
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compliance with FDA regulations, and |
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the need for further FDA approval if manufacturers make material changes to
manufacturing processes and/or facilities. |
We cannot guarantee that problems will not arise with production yields, costs or quality as we and
our suppliers manufacture our products. Any manufacturing problems could delay or limit our
supplies which would hinder our marketing and sales efforts. If our facility, any facility of our
contract manufacturers, or any equipment in those facilities is damaged or destroyed, we may not be
able to quickly or inexpensively replace it. Likewise, if there are any quality or supply problems
with any components or materials needed to manufacturer our products, we may not be able to quickly
remedy the problem(s). Any of these problems could cause our sales to suffer.
6
We Have Only Limited Experience Marketing And Selling Pharmaceutical Products And, As A Result, Our
Revenues From Product Sales May Suffer.
If we are unable to successfully market and sell sufficient quantities of our products,
revenues from product sales will be lower than anticipated and our financial condition may be
adversely affected. We are responsible for marketing our products in the United States and the rest
of the world, except Canada, Latin America and parts of Asia, where we have distributors. We are
doing so without the experience of having marketed pharmaceutical products prior to 2000. In
October 2003, DUSA began hiring a small direct sales force and we increased the size of our sales
force to market our products in the United States. If our sales and marketing efforts fail, then
sales of the Levulan® Kerastick®, the BLU-U®, Nicomide®
and other products will be adversely affected.
The Commercial Success Of Any Products That We May Develop Will Depend Upon The Degree Of Market
Acceptance Of Our Products Among Physicians, Patients, Health Care Payors, Private Health Insurers
And The Medical Community.
Our ability to commercialize any products that we may develop will be highly dependent upon
the extent to which these products gain market acceptance among physicians, patients, health care
payors, such as Medicare and Medicaid, private health insurers, including managed care
organizations and group purchasing organizations, and the medical community. If these products do
not achieve an adequate level of acceptance, we may not generate material product revenues, and we
may not become profitable. The degree of market acceptance of our product candidates, if approved
for commercial sale, will depend on a number of factors, including:
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the effectiveness, or perceived effectiveness, of our products in comparison to
competing products; |
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the existence of any significant side effects, as well as their severity in
comparison to any competing products; |
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potential advantages over alternative treatments; |
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the ability to offer our products for sale at competitive prices; |
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relative convenience and ease of administration; |
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the strength of marketing and distribution support; and |
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sufficient third-party coverage or reimbursement. |
If We Cannot Improve Physician Reimbursement And/Or Convince More Private Insurance Carriers To
Adequately Reimburse Physicians For Our Product Sales May Suffer.
Without adequate levels of reimbursement by government health care programs and private health
insurers, the market for our Levulan® Kerastick® for AK therapy will be
limited. While we continue to support efforts to improve reimbursement levels to physicians and are
working with the major private insurance carriers to improve coverage for our therapy, if our
efforts are not successful, a broader adoption of our therapy and sales of our products could be
negatively impacted. Although positive reimbursement changes related to AK were made in 2005, 2007
and again in 2008, some physicians still believe that reimbursement levels do not fully reflect the
required efforts to routinely execute our therapy in their practices.
If insurance companies do not cover, or stop covering products which are covered, including
Nicomide®, our sales could be dramatically reduced.
We Have Significant Losses And Anticipate Continued Losses
We have a history of operating losses. We expect to have continued losses until sales of our
products increase substantially. We incurred net losses of $1,284,000 and $3,371,000 for the
three-month periods ended
7
March 31, 2008 and 2007, respectively, and $14,714,000 and $31,350,000 for the years ended
December 31, 2007 and 2006, respectively. As of March 31, 2008, our accumulated deficit was
approximately $136,900,000. We cannot predict whether any of our products will achieve significant
enough market acceptance or generate sufficient revenues to enable us to become profitable on a
sustainable basis.
We Have Limited Patent Protection, And If We Are Unable To Protect Our Proprietary Rights,
Competitors Might Be Able To Develop Similar Products To Compete With Our Products And Technology.
Our ability to compete successfully depends, in part, on our ability to defend patents that
have issued, obtain new patents, protect trade secrets and operate without infringing the
proprietary rights of others. We have no compound patent protection for our Levulan®
brand of the compound ALA. Our basic ALA patents are for methods of detecting and treating various
diseased tissues using ALA (or related compounds called precursors), in combination with light. We
own or exclusively license ALA patents and patent applications related to the following:
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methods of using ALA and its unique physical forms in combination with light, |
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compositions and apparatus for those methods, and |
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unique physical forms of ALA. |
We have limited ALA patent protection outside the United States, which may make it easier for
third-parties to compete there. Our basic method of treatment patents and applications have
counterparts in only six foreign countries, and certain countries under the European Patent
Convention. Even where we have patent protection, there is no guarantee that we will be able to
enforce our patents. Additionally, enforcement of a given patent may not be practicable or an
economically viable alternative.
Some of the indications for which we may develop PDT therapies may not be covered by the
claims in any of our existing patents. Even with the issuance of additional patents to DUSA, other
parties are free to develop other uses of ALA, including medical uses, and to market ALA for such
uses, assuming that they have obtained appropriate regulatory marketing approvals. ALA in the
chemical form has been commercially supplied for decades, and is not itself subject to patent
protection. There are reports of third-parties conducting clinical studies with ALA in countries
outside the United States where PARTEQ, the licensor of our ALA patents, does not have patent
protection. In addition, a number of third-parties are seeking patents for uses of ALA not covered
by our patents. These other uses, whether patented or not, and the commercial availability of ALA,
could limit the scope of our future operations because ALA products could come on the market which
would not infringe our patents but would compete with our Levulan® products even though
they are marketed for different uses.
Nicomide® is covered by a United States patent which issued in December 2005.
Rivers Edge Pharmaceuticals, LLC filed an application with the USPTO for the reexamination of the
patent which was vacated by the USPTO on March 6, 2008. On October 28, 2007, we entered into a
settlement agreement and mutual release to dismiss the lawsuit brought by DUSA against Rivers
Edge, asserting a number of claims arising out of Rivers Edges alleged infringement of U.S.
Patent No. 6,979,468 under which DUSA has marketed, distributed and sold Nicomide®.
Under the terms of the settlement agreement, Rivers Edge unconditionally acknowledges the validity
and enforceability of the Nicomide® patent. Other companies may launch substitutable
niacinamide products which may cause us to again consider litigation and the validity of the
Nicomide® patent could be tested again. Also, new products have been launched that are
competing with Nicomide®. These events could cause us to lose significant revenues and
put our ability to be profitable at risk.
Furthermore, PhotoCure received FDA approval to market Metvixia® for treatment of
AKs in July 2004 and this product, which would be directly competitive with our Levulan®
Kerastick® product, could be launched at any time. While we are entitled to royalties
from PhotoCure on its net sales of Metvixia®, this product which will be marketed in the
U.S. by a large dermatology company, may adversely affect our ability to maintain or increase our
Levulan® market.
8
While we attempt to protect our proprietary information as trade secrets through agreements
with each employee, licensing partner, consultant, university, pharmaceutical company and agent, we
cannot guarantee that these agreements will provide effective protection for our proprietary
information. It is possible that:
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these persons or entities might breach the agreements, |
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we might not have adequate remedies for a breach, and/or |
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our competitors will independently develop or otherwise discover our trade
secrets; |
all of which could negatively impact our ability to be profitable.
We Have Only Three Therapies That Have Received Regulatory Approval Or Clearance, And We Cannot
Predict Whether We Will Ever Develop Or Commercialize Any Other Levulan
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Products.
Our Potential Products Are In Early Stages Of Development And May Never Result In Any
Commercially Successful Products.
To be profitable, we must successfully research, develop, obtain regulatory approval for,
manufacture, introduce, market and distribute our products. Except for Levulan® PDT for
AKs, the BLU-U® for acne, the ClindaReach pledget and the currently marketed products
we acquired in our merger with Sirius, all of our other potential Levulan® and other
potential product candidates are at an early stage of development and subject to the risks of
failure inherent in the development of new pharmaceutical products and products based on new
technologies. These risks include:
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delays in product development, clinical testing or manufacturing, |
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unplanned expenditures in product development, clinical testing or
manufacturing, |
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failure in clinical trials or failure to receive regulatory approvals, |
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emergence of superior or equivalent products, |
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inability to market products due to third-party proprietary rights, and |
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failure to achieve market acceptance. |
We cannot predict how long the development of our investigational stage products will take or
whether they will be medically effective. We cannot be sure that a successful market will continue
to develop for our Levulan® drug technology.
We Must Receive Separate Approval For Each Of Our Potential Products Before We Can Sell Them
Commercially In The United States Or Abroad.
All of our potential Levulan® products will require the approval of the FDA before
they can be marketed in the United States. If we fail to obtain the required approvals (as we did
for the product we were developing with Altana) for these products our revenues will be limited.
Before an application to the FDA seeking approval to market a new drug, called an NDA, can be
filed, a product must undergo, among other things, extensive animal testing and human clinical
trials. The process of obtaining FDA approvals can be lengthy, costly, and time-consuming.
Following the acceptance of an NDA, the time required for regulatory approval can vary and is
usually one to three years or more. The FDA may require additional animal studies and/or human
clinical trials before granting approval. Our Levulan® PDT products are based on
relatively new technology. To the best of our knowledge, the FDA has approved only three drugs for
use in photodynamic therapy, including Levulan®. This factor may lengthen the approval
process. We face much trial and error and we may fail at numerous stages along the way.
9
We cannot predict whether we will obtain approval for any of our potential products. Data
obtained from preclinical testing and clinical trials can be susceptible to varying interpretations
which could delay, limit or prevent regulatory approvals. Future clinical trials may not show that
Levulan® PDT or photodetection, known as PD, is safe and effective for any new use we
are studying, including our ongoing Phase II acne study. In addition, delays or disapprovals may be
encountered based upon additional governmental regulation resulting from future legislation or
administrative action or changes in FDA policy. During September 2005, the FDA issued guidance for
the pharmaceutical industry regarding the development of new drugs for acne vulgaris treatment. We
have received comments on our acne development program from the FDA statistical reviewer assigned
to our investigational new drug application or IND. In this letter, the reviewer stated concern
about whether we will have sufficient data to select an appropriate dosing regimen for Phase III
trials. We believe that we have the data to indicate that sufficient drug dose ranging has been
done; however, if the FDA does not accept our rationale, additional clinical trials and/or
formulation development work may be required for the acne development program, which may extend the
expected development time lines for such program. The FDA may issue additional guidance in the
future, which may result on additional costs and delays. We must also obtain foreign regulatory
clearances before we can market any potential products in foreign markets. The foreign regulatory
approval process includes all of the risks associated with obtaining FDA marketing approval and may
impose substantial additional costs.
Certain of the products acquired in connection with the Sirius merger must meet certain
minimum manufacturing and labeling standards established by the FDA and applicable to products
marketed without approved marketing applications, including Nicomide®. The FDA regulates
such products under its marketed unapproved drugs compliance policy guide entitled, Marketed New
Drugs without Approved NDAs or ANDAs. Under this policy, the FDA recognizes that certain
unapproved products, based on the introduction date of their active ingredients and the lack of
safety concerns, have been marketed for many years and, at this time, will not be the subject of
any enforcement action. The FDA has recently taken a more proactive role and is strongly
encouraging manufacturers of such products to submit applications to obtain marketing approval and
we have begun discussions with the FDA to begin that process. The FDAs enforcement discretion
policy does not apply to drugs or firms that may be in violation of regulatory requirements other
than preapproval submission requirements and the FDA may bring an action against a drug or a firm
when the FDA concludes that such other violations exist. The contract manufacturer of
Nicomide® received notice that the FDA considers prescription dietary supplements to be
unapproved new drugs that are misbranded and that cannot be legally marketed, and has received
notice that the FDA believes Nicomide® could not be marketed as a dietary supplement
with its current labeling. In April 2008, we were notified by the contract manufacturer of
Nicomide® that they will cease manufacturing Nicomide® due to their
continuing discussions with the U.S. Food and Drug Administration. We have inventory supplies of
Nicomide®, either in the distribution channel or at wholesalers, to last approximately 6
months at current sales levels. We are evaluating alternative manufacturing, labeling and
distribution strategies in order to maintain Nicomide® on the market, but we could
experience a back-order situation if a replacement manufacturer is not available in time to meet
our supply needs. We may be required to make certain labeling changes and market
Nicomide® as an over-the-counter product or as a dietary supplement under applicable
legislation, or withdraw the product from the market, unless and until we submit a marketing
application and obtain FDA marketing approval. If FDA takes action against Nicomide, or other
unapproved marketed drugs we sell which we acquired from Sirius, our revenues will be significantly
negatively impacted.
Because Of The Nature Of Our Business, The Loss Of Key Members Of Our Management Team Could Delay
Achievement Of Our Goals.
We are a small company with only 90 employees, including 4 part-time employees, as of March
31, 2008. We are highly dependent on several key officer/employees with specialized scientific and
technical skills without whom our business, financial condition and results of operations would
suffer, especially in the photodynamic therapy portion of our business. The photodynamic therapy
industry is still quite small and the number of experts is limited. The loss of these key employees
could cause significant delays in achievement of our business and research goals since very few
people with their expertise could be hired. Our growth and future success will depend, in large
part, on the continued contributions of these key individuals as well as our ability to motivate
and retain other qualified personnel in our specialty drug and light device areas.
10
Collaborations With Outside Scientists May Be Subject To Restriction And Change.
We work with scientific and clinical advisors and collaborators at academic and other
institutions that assist us in our research and development efforts. These scientists and advisors
are not our employees and may have other commitments that limit their availability to us. Although
our advisors and collaborators generally agree not to do competing work, if a conflict of interest
between their work for us and their work for another entity arises, we may lose their services. In
addition, although our advisors and collaborators sign agreements not to disclose our confidential
information, it is possible that valuable proprietary knowledge may become publicly known through
them.
Risks Related To Our Industry
Product Liability And Other Claims Against Us May Reduce Demand For Our Products Or Result In
Damages.
We Are Subject To Risk From Potential Product Liability Lawsuits Which Could Negatively Affect
Our Business.
The development, manufacture and sale of medical products expose us to product liability
claims related to the use or misuse of our products. Product liability claims can be expensive to
defend and may result in significant judgments against us. A successful claim in excess of our
insurance coverage could materially harm our business, financial condition and results of
operations. Additionally, we cannot guarantee that continued product liability insurance coverage
will be available in the future at acceptable costs. If the cost is too high, we may have to
self-insure.
Our Business Involves Environmental Risks And We May Incur Significant Costs Complying With
Environmental Laws And Regulations.
We have used various hazardous materials, such as mercury in fluorescent tubes in our research
and development activities. We are subject to federal, state and local laws and regulations which
govern the use, manufacture, storage, handling and disposal of hazardous materials and specific
waste products. Now that we have established our own production line for the manufacture of the
Kerastick®, we are subject to additional environmental laws and regulations. We believe
that we are in compliance in all material respects with currently applicable environmental laws and
regulations. However, we cannot guarantee that we will not incur significant costs to comply with
environmental laws and regulations in the future. We also cannot guarantee that current or future
environmental laws or regulations will not materially adversely affect our operations, business or
assets. In addition, although we believe our safety procedures for handling and disposing of these
materials comply with federal, state and local laws and regulations, we cannot completely eliminate
the risk of accidental contamination or injury from these materials. In the event of such an
accident, we could be held liable for any resulting damages, and this liability could exceed our
resources.
We May Not Be Able To Compete Against Traditional Treatment Methods Or Keep Up With Rapid Changes
In The Biotechnology And Pharmaceutical Industries That Could Make Some Or All Of Our Products
Non-Competitive Or Obsolete.
Competing Products And Technologies Based On Traditional Treatment Methods May Make Some Or All
Of Our Programs Or Potential Products Noncompetitive Or Obsolete.
Well-known pharmaceutical, biotechnology and medical device companies are marketing
well-established therapies for the treatment of many of the same conditions that we are seeking to
treat, including AKs, acne and rosacea. Doctors may prefer to use familiar methods, rather than
trying our products. Reimbursement issues affect the economic competitiveness of our products as
compared to other more traditional therapies.
Many companies are also seeking to develop new products and technologies, and receiving
approval for medical conditions for which we are developing treatments. Our industry is subject to
rapid, unpredictable and
11
significant technological change. Competition is intense. Our competitors may succeed in
developing products that are safer or more effective than ours. Many of our competitors have
substantially greater financial, technical and marketing resources than we have. In addition,
several of these companies have significantly greater experience than we do in developing products,
conducting preclinical and clinical testing and obtaining regulatory approvals to market products
for health care.
We cannot guarantee that new drugs or future developments in drug technologies will not have a
material adverse effect on our business. Increased competition could result in:
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price reductions, |
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lower levels of third-party reimbursements, |
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failure to achieve market acceptance, and |
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loss of market share, any of which could adversely affect our business. Further,
we cannot give any assurance that developments by our competitors or future
competitors will not render our technology obsolete. |
On May 30, 2006, we entered into a patent license agreement with PhotoCure ASA whereby DUSA
granted a non-exclusive license to PhotoCure under the patents DUSA licenses from PARTEQ, for
esters of ALA. Furthermore, DUSA granted a non-exclusive license to PhotoCure for its existing
formulations of its Hexvix® and Metvix® (known in the United States as Metvixia®) products for any
DUSA patents that may issue or be licensed by DUSA in the future. PhotoCure received FDA approval
to market Metvixia for treatment of AKs in July 2004 and it would be directly competitive with our
Levulan® Kerastick® product should PhotoCure decide to begin marketing this product. While we are
entitled to royalties from PhotoCure on its net sales of Metvixia, this product, which will be
marketed in the U.S. by a large dermatology company which may start to market Metvixia at any time,
would adversely affect our ability to maintain or increase our market.
We Have Learned That Some Compounding Pharmacies Are Producing A Form Of Aminolevulinic Acid Hcl
And Are Marketing It To The Medical Community.
We are aware that there are compounding pharmacies that market compounded versions of
aminolevulinic acid HCl as an alternative to our Levulan® product. Since December 2004,
we have filed lawsuits against compounding pharmacies, chemical suppliers and a light device
company and several physicians alleging violations of the Lanham Act for false advertising and
trademark infringement, and of United States patent law. All of the lawsuits have been settled or
ended favorably to us. While we believe that certain actions of compounding pharmacies and others
go beyond the activities which are permitted under the Food, Drug and Cosmetic Act and have advised
the FDA and local health authorities of our concerns, we cannot be certain that our legal strategy
will be successful in curbing the practices of these companies or that regulatory authorities will
intervene to stop their activities. In addition, there may be other compounding pharmacies which
are following FDA guidelines, or others conducting illegal activities of which we are not aware,
which may be negatively impacting our sales revenues.
Generic Manufacturers May Launch Products at Risk of Patent Infringement.
We are aware that another manufacturer has listed a niacinamide product in various drug
databases and we have been informed that other companies are making plans to launch a substitutable
niacinamide product to complete with Nicomide®. If manufacturers, like Rivers Edge,
launch products to compete with Nicomide® in spite of our patent position, these
manufacturers would likely erode our market and negatively impact our sales revenues, liquidity and
operations.
12
Our Competitors In The Biotechnology And Pharmaceutical Industries May Have Better Products,
Manufacturing Capabilities Or Marketing Expertise.
We are aware of several companies commercializing and/or conducting research with ALA or
ALA-related compounds, including: medac GmbH and photonamic GmbH & Co. KG (Germany); Biofrontera,
PhotoTherapeutics, Inc. (U.K.) and PhotoCure ASA (Norway) which entered into a marketing agreement
with Galderma S.A. for countries outside of Nordic countries for certain dermatology indications.
We also anticipate that we will face increased competition as the scientific development of PDT and
PD advances and new companies enter our markets. Several companies are developing PDT agents other
than Levulan®. These include: QLT Inc. (Canada); Axcan Pharma Inc. (U.S.); Miravant,
Inc. (U.S.); and Pharmacyclics, Inc. (U.S.). There are many pharmaceutical companies that compete
with us in the field of dermatology, particularly in the acne and rosacea markets.
PhotoCure has received marketing approval of its ALA precursor (ALA methyl-ester) compound for
PDT treatment of AKs and basal cell carcinoma in the European Union, New Zealand, Australia and
countries in Scandinavia. PhotoCures marketing partner, a large dermatology company, could begin
to market its product in direct competition with Levulan® in the U.S., at any time,
under the terms of our patent license agreement and we may lose market share.
Axcan Pharma Inc. has received FDA approval for the use of its product, PHOTOFRIN®,
for PDT in the treatment of high grade dysplasia associated with Barretts Esophagus. Axcan is the
first company to market a PDT therapy for this indication for which we designed our proprietary
sheath device and have conducted pilot clinical trials.
We expect that our principal methods of competition with other PDT products will be based upon
such factors as:
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the ease of administration of our method of PDT, |
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the degree of generalized skin sensitivity to light, |
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the selectivity of our drug for the target lesion or tissue of interest, and |
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the type and cost of our light systems. |
Our primary competition in the acne and rosacea markets include oral and topical antibiotics,
other topical prescription and over-the-counter products, as well as various laser and non-laser
light treatments. The market is highly competitive and other large and small companies have more
experience than we do which could make it difficult for us to penetrate the market. We are also
aware of new products that were launched recently which will compete with Nicomide®
which could negatively impact our market share. The entry of new products from time to time would
likely cause us to lose market share.
Risks Related To Our Stock
If The Shares Of Common Stock Held By Former Sirius Shareholders Or Our New Investors Are Sold, The
Price Of Our Shares Could Become Depressed.
All of the shares of DUSAs common stock which were issued to the former Sirius shareholders
were subject to a lock-up provision under the terms of the merger agreement. On March 10, 2007, the
lock-up provision on 1,380,151 shares was lifted and the lock-up on the remaining 1,016,094 shares
was lifted on March 10, 2008. These shares have been registered and are freely tradable. In
addition, in October 2007 we privately placed 4,581,043 shares of DUSAs common stock with several
investors. These shares have been registered and are freely tradable. If any of these shareholders
decide to sell their shares, the price of our common stock on NASDAQ could be depressed.
13
If Outstanding Options, Warrants And Rights Are Converted, The Value Of Those Shares Of Common
Stock Outstanding Just Prior To The Conversion Will Be Diluted.
As of May 6, 2008, there were outstanding options and warrants to purchase 4,214,009 shares of
common stock, with exercise prices ranging from $1.60 to $31.00 per share, and from $2.85 to $6.00
per share, respectively. The holders of the options and warrants have the opportunity to profit if
the market price for the common stock exceeds the exercise price of their respective securities,
without assuming the risk of ownership. The holders are likely to exercise their securities when we
would probably be able to raise capital from the public on terms more favorable than those provided
in these securities.
Our Results Of Operations And General Market Conditions For Specialty Pharmaceutical And
Biotechnology Stocks Could Result In Sudden Changes In The Market Value Of Our Stock.
The price of our common stock has been highly volatile. These fluctuations create a greater
risk of capital losses for our shareholders as compared to less volatile stocks. From January 1,
2007 to May 6, 2008, the price of our stock has ranged from a low of $1.63 to a high of $11.12.
Factors that contributed to the volatility of our stock during this period included:
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quarterly levels of product sales; |
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clinical trial results; |
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general market conditions; |
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patent litigation; |
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increased marketing activities or press releases; and |
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changes in third-party payor reimbursement for our therapy. |
The significant general market volatility in similar stage pharmaceutical and biotechnology
companies made the market price of our common stock even more volatile.
Significant Fluctuations In Orders For Our Products, On A Monthly And Quarterly Basis, Are Common
Based On External Factors And Sales Promotion Activities. These Fluctuations Could Increase The
Volatility Of Our Stock Price.
The price of our common stock may be affected by the amount of quarterly shipments of our
products to end-users. Since our PDT products are still in the early stages of adoption, and sales
volumes are still low, a number of factors could affect product sales levels and growth rates in
any period. These could include the level of penetration of new markets outside of the United
States, the timing of medical conferences, sales promotion activities, and large volume purchases
by our higher usage customers. In addition, seasonal fluctuations in the number of patients seeking
treatment at various times during the year could impact sales volumes. These factors could, in
turn, affect the volatility of our stock price.
Effecting A Change Of Control Of DUSA Would Be Difficult, Which May Discourage Offers For Shares Of
Our Common Stock.
Our certificate of incorporation authorizes the board of directors to issue up to 100,000,000
shares of stock, 40,000,000 of which are common stock. The board of directors has the authority to
determine the price, rights, preferences and privileges, including voting rights, of the remaining
60,000,000 shares without any further vote or action by the shareholders. The rights of the holders
of our common stock will be subject to, and may be adversely affected by, the rights of the holders
of any preferred stock that may be issued in the future.
14
On September 27, 2002, we adopted a shareholder rights plan at a special meeting of DUSAs
board of directors. The rights plan could discourage, delay or prevent a person or group from
acquiring 15% or more of our common stock, thereby limiting, perhaps, the ability of our
shareholders to benefit from such a transaction.
The rights plan provides for the distribution of one right as a dividend for each outstanding
share of our common stock to holders of record as of October 10, 2002. Each right entitles the
registered holder to purchase one one-thousandths of a share of preferred stock at an exercise
price of $37.00 per right. The rights will be exercisable subsequent to the date that a person or
group either has acquired, obtained the right to acquire, or commences or discloses an intention to
commence a tender offer to acquire, 15% or more of our outstanding common stock or if a person or
group is declared an Adverse Person, as such term is defined in the rights plan. The rights may
be redeemed by DUSA at a redemption price of one one-hundredth of a cent per right until ten days
following the date the person or group acquires, or discloses an intention to acquire, 15% or more,
as the case may be, of DUSA, or until such later date as may be determined by the our board of
directors.
Under the rights plan, if a person or group acquires the threshold amount of common stock, all
holders of rights (other than the acquiring person or group) may, upon payment of the purchase
price then in effect, purchase shares of common stock of DUSA having a value of twice the purchase
price. In the event that we are involved in a merger or other similar transaction where DUSA is not
the surviving corporation, all holders of rights (other than the acquiring person or group) shall
be entitled, upon payment of the purchase price then in effect, to purchase common stock of the
surviving corporation having a value of twice the purchase price. The rights will expire on October
10, 2012, unless previously redeemed. Our board of directors has also adopted certain amendments to
DUSAs certificate of incorporation consistent with the terms of the rights plan.
15
SPECIAL NOTE REGARDING FORWARD LOOKING STATEMENTS
This prospectus includes or incorporates forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of
the Securities Exchange Act of 1934, as amended, or the Exchange Act. All statements, other than
statements of historical facts, included or incorporated in this prospectus regarding our strategy,
future operations, financial position, future revenues, projected costs, prospects, plans and
objectives of management are forward-looking statements. The words anticipates, believes,
estimates, expects, intends, may, plans, projects, will, would and similar
expressions are intended to identify forward-looking statements, although not all forward-looking
statements contain these identifying words. We cannot guarantee that we actually will achieve the
plans, intentions or expectations disclosed in our forward-looking statements and you should not
place undue reliance on our forward-looking statements. Actual results or events could differ
materially from the plans, intentions and expectations disclosed in the forward-looking statements
we make. We have included important factors in the cautionary statements included or incorporated
in this prospectus, particularly under the heading Risk Factors, that we believe could cause
actual results or events to differ materially from the forward-looking statements that we make. Our
forward-looking statements do not reflect the potential impact of any future acquisitions, mergers,
dispositions, joint ventures or investments we may make. We do not assume any obligation to update
any forward-looking statements.
You should not unduly rely on forward-looking statements contained or incorporated by
reference in this prospectus. Actual results or outcomes may differ materially from those predicted
in our forward-looking statements due to the risks and uncertainties inherent in our business,
including, without limitation, statements regarding our strategies and core objectives for 2008,
the results of our integration of Sirius Laboratories, Inc. with our business and matters relating
thereto, our expectations concerning the introduction of generic substitutes for Nicomide® and such
products impact on sales of Nicomide®, our use of estimates and assumptions in the preparation of
our financial statements and policies and impact on us of the adoption of certain accounting
standards, the impact of compounding pharmacies, beliefs regarding estimates, managements beliefs
regarding the unique nature of Levulan® and its use and potential use, expectations regarding the
timing of results of clinical trials, future development of Levulan® and our other products and
other potential indications, statements regarding the manufacture of Nicomide® in the future,
beliefs concerning manufacture of the BLU-U®, intention to pursue licensing, marketing,
co-promotion, collaboration or acquisition opportunities, status of clinical programs for all other
indications and beliefs regarding potential efficacy and marketing, our beliefs regarding the
safety, simplicity, reliability and cost-effectiveness of certain light sources, our expectations
regarding other product launches in Brazil and other territories, expectations regarding additional
market expansion, expectations for commercialization of Levulan® Kerastick® in Asian countries and
a distribution agreement for Japan, expectations regarding the marketing and distribution of
Levulan® Kerastick® by Daewoong Pharmaceutical Co., Ltd. and Stiefel Laboratories, Inc., beliefs
regarding the clinical benefit of Levulan® PDT for acne and other indications, beliefs regarding
the suitability of clinical data, expectations regarding the confidentiality of our proprietary
information, statements of our intentions to seek additional U.S. and foreign regulatory approvals,
and to market and increase sales outside the U.S., beliefs regarding regulatory classifications,
filings, timelines, off-label use and environmental compliance, beliefs concerning patent disputes
and litigation, intentions to defend our patent estate, the impact of a third-partys regulatory
compliance and fulfillment of contractual obligations, and our anticipation that third parties will
launch products upon receipt of regulatory approval, expectations of increases or decreases in cost
of product sales, expected use of cash resources, requirements of cash resources for our future
liquidity, beliefs regarding investments and economic conditions, expectations regarding
outstanding options and warrants and our dividend policy, anticipation of increases or decreases in
personnel, beliefs regarding the effect of reimbursement policies on revenues and acceptance of our
therapies, expectations for future strategic opportunities and research and development programs
and expenses, expectations for continuing operating losses and competition including from Metvixia,
expectations regarding the adequacy and availability of insurance, expectations regarding general
and administrative costs, expectations regarding increased sales and marketing costs and research
and development costs, levels of interest income and our capital resource needs, intention to raise
additional funds to meet capital requirements and the potential dilution and impact on our
business, potential for additional inspection and testing of our manufacturing facilities or
additional FDA actions, beliefs regarding the adequacy of our inventory of Kerastick® and BLU-U®
units and of Nicomide®, our manufacturing capabilities and the impact of inventories on revenues,
beliefs regarding interest rate risks to our investments and effects of inflation, beliefs
regarding the impact of any current or future legal proceedings, dependence on key personnel, and
beliefs concerning product liability
16
insurance, the enforceability of our patents, the impact of generic products, our beliefs
regarding our sales and marketing efforts, competition with other companies, the adoption of our
products, and the outcome of such efforts, our beliefs regarding our sales and marketing efforts,
our beliefs regarding the use of our products and technologies by third parties, our beliefs
regarding our compliance with applicable laws, rules and regulations, our beliefs regarding
available reimbursement for our products, our beliefs regarding the current and future clinical
development and testing of our potential products and technologies and the costs thereof, the
volatility of our stock price, the impact of our rights plan, and the possibility that the holders
of options and warrants will purchase our common stock by exercising these securities. These
forward-looking statements are further qualified by important factors that could cause actual
results to differ materially from those in the forward-looking statements. These factors include,
without limitation, changing market and regulatory conditions, actual clinical results of our
trials, the impact of competitive products and pricing, the timely development, FDA and foreign
regulatory approval, and market acceptance of our products, environmental risks relating to our
products, reliance on third-parties for the production, manufacture, sales and marketing of our
products, the availability of products for acquisition and/or license on terms agreeable to us,
sufficient sources of funds, the securities regulatory process, the maintenance of our patent
portfolio and ability to obtain competitive levels of reimbursement by third-party payors, none of
which can be assured. Results actually achieved may differ materially from expected results
included in these statements as a result of these or other factors.
You should read and interpret any forward-looking statements together with the following
documents:
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our most recent Annual Report on Form 10-K; |
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our most recent Quarterly Report on Form 10-Q; |
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our most recent Current Reports on Form 8-K; |
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the risk factors contained in this prospectus under the caption Risk Factors;
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our other filings with the Securities and Exchange Commission. |
Any forward-looking statement speaks only as of the date on which that statement is made. We
will not update any forward-looking statement to reflect events or circumstances that occur after
the date on which such statement is made.
CONSOLIDATED
RATIO OF EARNINGS TO FIXED CHARGES AND EARNINGS TO COMBINED
FIXED CHARGES AND PREFERRED STOCK DIVIDENDS
During the periods reflected below, our earnings were inadequate to cover fixed charges. The
following table sets forth our coverage deficiency based upon the ratio of earnings to fixed
charges for the periods indicated. For the periods presented, we had no preferred stock
outstanding. Accordingly, the ratio of earnings to combined fixed charges and preferred stock
dividends are identical to the consolidated ratio of earnings to fixed charges.
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Three |
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Months |
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Ended |
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March 31, |
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Year Ended December 31, |
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2008 |
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2007 |
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2006 |
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2005 |
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2004 |
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2003 |
Deficiency of
earnings available
to cover fixed
charges (in
thousands) |
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$ |
(1,284 |
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$ |
(14,714 |
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$ |
(31,350 |
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$ |
(14,999 |
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$ |
(15,629 |
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$ |
(14,829 |
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17
USE OF PROCEEDS
Unless the applicable prospectus supplement states otherwise, we expect to use the net
proceeds of the sale of these securities for general corporate purposes, which may include working
capital, capital expenditures, acquisitions, joint ventures and stock repurchase programs. As of
the date of this prospectus, we have not identified as probable any specific material proposed uses
of these proceeds. The amount of securities offered from time to time pursuant to this prospectus
and any prospectus supplement, and the precise amounts and timing of the application of net
proceeds from the sale of those securities, will depend upon our funding requirements. If at the
time of an issuance of securities we elect to make different or more specific use of proceeds than
described in this prospectus, such use will be described in the prospectus supplement relating to
those securities.
18
DESCRIPTION OF COMMON STOCK
This section describes the general terms of our common stock. A prospectus supplement may
provide information that is different from this prospectus. If the information in the prospectus
supplement with respect to our common stock being offered differs from this prospectus, you should
rely on the information in the prospectus supplement. A copy of our certificate of incorporation,
as amended, has been incorporated by reference from our filings with the SEC as an exhibit to the
registration statement. Our common stock and the rights of the holders of our common stock are
subject to the applicable provisions of the New Jersey Business Corporation Act, which we refer to
as New Jersey law, our certificate of incorporation and our bylaws, each as amended, the rights of
the holders of our preferred stock, if any, as well as the terms of our senior indebtedness and
senior subordinated indebtedness, if any.
The prospectus supplement relating to an offering of common stock will describe relevant terms
of the offering, including the number of shares offered, the initial offering price, market price
and dividend information.
Under our certificate of incorporation, as amended, we have the authority to issue 100,000,000
shares of stock; 40,000,000 of which are designated as common stock and 60,000,000 of which the
board of directors has the power and is authorized to divide into classes and into series within
any class or classes, to determine the designation and the number of shares of any class or series,
to determine the relative rights, preferences and limitations of the shares of any class or series,
including, but not limited to, the convertibility of any shares of one class or series into shares
of another class or series, and to change the designation or number of shares, or the relative
rights, preferences, or limitations of the shares, of any theretofore established class or series.
Of the 40,000,000 shares of common stock we are authorized to issue, 24,078,452 shares of our
common stock were outstanding on March 31, 2008. As of March 31, 2008, up to 4,932,650 shares of
our common stock are issued or issuable upon exercise of stock options and warrants that have been,
or stock options, stock appreciation rights, stock awards and restricted stock units that may be,
issued pursuant to our warrant agreements and our various stock option and equity compensation
plans. Of the 60,000,000 shares of undesignated stock that our board of directors is authorized to
issue, 40,000 shares have been designated as Series A Junior Participating Preferred Stock, without
par value. Of the remaining 59,960,000 shares of undesignated stock available for issuance, any
shares designated by the board of directors as a class or series of preferred stock will reduce the
number of shares available for designation as common stock.
The following description of our common stock, and any description of our common stock in a
prospectus supplement may not be complete and is subject to, and qualified in its entirety by
reference to, New Jersey law and the actual terms and provisions contained in our certificate of
incorporation and bylaws, each as amended from time to time.
Preemptive Rights
The holders of our common stock do not have preemptive rights to purchase or subscribe for any
stock or other securities of ours.
Voting Rights
Each outstanding share of our common stock is entitled to one vote per share of record on all
matters to be voted upon by shareholders and to vote together as a single class for the election of
directors and in respect of other corporate matters. At a meeting of shareholders at which a quorum
is present, for all matters other than the election of directors, a majority of the votes cast
decides all questions, unless the matter is one upon which a different vote is required by express
provision of New Jersey law or our certificate of incorporation or bylaws. Directors are elected by
a plurality of the votes of the shares present at a meeting. There is no cumulative voting with
respect to the election of directors or any other matter.
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Dividends
Holders of our common stock are entitled to receive dividends or other distributions when and
if declared by our board of directors. The right of our board of directors to declare dividends,
however, is subject to any rights of the holders of other classes of our capital stock, if any, and
the availability of sufficient funds under New Jersey law to pay dividends.
Anti-Takeover Effects of Provisions of the Certificate of Incorporation and Bylaws
Our certificate of incorporation and bylaws, each as amended, contain provisions which could
delay or prevent a third party from acquiring shares of our common stock or replacing members of
our board of directors. Our certificate of incorporation allows our board of directors to issue
shares of preferred stock. Our board of directors can determine the price, rights, preferences, and
privileges of those shares without any further vote or action by the shareholders. As a result, our
board of directors could make it difficult for a third party to acquire a majority of our
outstanding voting stock. Since management is appointed by the board of directors, any inability to
effect a change in the board of directors may result in the entrenchment of management.
Our bylaws, as amended, do not permit our shareholders to call a special meeting of
shareholders. Under the bylaws, only our president or a majority of the board of directors are able
to call special meetings. The inability of shareholders to call a special meeting may make it
difficult for shareholders to remove or replace the board of directors should they desire to do so.
Our directors may be removed from our board of directors only for cause. These provisions may delay
or prevent changes of control or management, either by third parties or by shareholders seeking to
change control or management.
In September 2002, we entered into a Rights Agreement with American Stock Transfer and Trust
Company. The rights agreement could discourage, delay or prevent a person or group from acquiring
15% or more of our common stock. The rights agreement provides that if a person acquires 15% or
more of our common stock without the approval of our board of directors, all other shareholders
will have the right to purchase securities from us at a price that is less than its fair market
value, which would substantially dilute and reduce the value of our common stock owned by the
acquiring person. As a result, our board of directors has significant discretion to approve or
disapprove a persons efforts to acquire 15% or more of our common stock.
Listing
We list our common stock on the Nasdaq Global Market under the symbol DUSA.
Limitation of Liability and Indemnification
Our certificate of incorporation and bylaws, each as amended, and New Jersey law limit the
liability of our directors and officers. Under our certificate of incorporation and bylaws and New
Jersey law, our directors and officers will not be personally liable for monetary damages for
breach of their fiduciary duties as directors and officers, except liability for:
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any breach of their duty of loyalty to the corporation or its shareholders; |
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acts or omissions not in good faith or which involve a knowing violation of law;
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any transaction from which the director derived an improper personal benefit. |
This provision has no effect on any non-monetary remedies that may be available to us or our
shareholders, nor does it relieve us or our officers or directors from compliance with federal or
state securities laws.
Insofar as indemnification for liabilities arising under the Securities Act may be permitted
to directors, officers or persons controlling us under the provisions that we describe above or
otherwise, we have been informed that in the opinion of the SEC, this indemnification is against
public policy as expressed in the Securities Act and is therefore unenforceable.
20
DESCRIPTION OF PREFERRED STOCK
This section describes the general terms of our preferred stock to which any prospectus
supplement may relate. A prospectus supplement will describe the terms relating to any preferred
stock to be offered by us in greater detail, and may provide information that is different from
this prospectus. If the information in the prospectus supplement with respect to the particular
preferred stock being offered differs from this prospectus, you should rely on the information in
the prospectus supplement. A copy of our certificate of incorporation, as amended, has been
incorporated by reference from our filings with the SEC as an exhibit to the registration
statement. A certificate of amendment to our certificate of incorporation will specify the terms of
the preferred stock being offered, and will be filed or incorporated by reference as an exhibit to
the registration statement before the preferred stock is issued.
Under our certificate of incorporation, as amended, we have the authority to issue 100,000,000
shares of stock; 40,000,000 of which are designated as common stock and 60,000,000 of which the
board of directors has the power and is authorized to divide into classes and into series within
any class or classes, to determine the designation and the number of shares of any class or series,
to determine the relative rights, preferences and limitations of the shares of any class or series,
including, but not limited to, the convertibility of any shares of one class or series into shares
of another class or series, and to change the designation or number of shares, or the relative
rights, preferences, or limitations of the shares, of any theretofore established class or series.
Of the 60,000,000 shares of undesignated stock that our board of directors is authorized to issue,
40,000 shares have been designated as Series A Junior Participating Preferred Stock, without par
value. Of the remaining 59,960,000 shares of undesignated stock available for issuance, any shares
designated by the board of directors as a class or series of common stock will reduce the number of
shares available for designation as preferred stock. Accordingly, our board of directors is
authorized, without action by the shareholders, to issue preferred stock from time to time with the
dividend, liquidation, conversion, voting, and other rights and restrictions as it may determine.
All shares of any one series of our preferred stock will be identical, except that shares of any
one series issued at different times may differ as to the dates from which dividends may be
cumulative.
If our board of directors decides to issue any preferred stock, it may discourage or make more
difficult a merger, tender offer, business combination or proxy contest, assumption of control by a
holder of a large block of our securities or the removal of incumbent management, even if these
events were favorable to the interests of shareholders. Our board of directors, without shareholder
approval, may issue preferred stock with voting and conversion rights and dividend and liquidation
preferences which may adversely affect the holders of common stock.
The following description of our preferred stock, and any description of our preferred stock
in a prospectus supplement may not be complete and is subject to, and qualified in its entirety by
reference to, New Jersey law and the actual terms and provisions contained in our certificate of
incorporation and bylaws, each as amended from time to time.
Terms
Unless provided in a supplement to this prospectus, the shares of our preferred stock to be
issued will have no preemptive rights. If preferred stock is offered by us, the prospectus
supplement will describe the terms of the preferred stock, including the following if applicable to
the particular offering:
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number of shares of preferred stock to be issued and the offering price of the
preferred stock; |
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the title and stated value of the preferred stock; |
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dividend rights, including dividend rates, periods, or payment dates, or methods
of calculation of dividends applicable to the preferred stock; |
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the date from which distributions on the preferred stock shall accumulate, if
applicable; |
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right to convert the preferred stock into a different type of security; |
21
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voting rights attributable to the preferred stock; |
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rights and preferences upon our liquidation or winding up of our affairs; |
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terms of redemption; |
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the procedures for any auction and remarketing, if any, for the preferred stock; |
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the provisions for a sinking fund, if any, for the preferred stock; |
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any listing of the preferred stock on any securities exchange; |
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the terms and conditions, if applicable, upon which the preferred stock will be
convertible into our common stock, including the conversion price (or manner of
calculation thereof); |
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a discussion of federal income tax considerations applicable to the preferred
stock; |
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the relative ranking and preferences of the preferred stock as to distribution
rights (including whether any liquidation preference as to the preferred stock will
be treated as a liability for purposes of determining the availability of assets
for distributions to holders of stock ranking junior to the shares of preferred
stock as to distribution rights); |
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any limitations on issuance of any series of preferred stock ranking senior to
or on a parity with the series of preferred stock being offered as to distribution
rights and rights upon the liquidation, dissolution or winding up or our
affairs; and |
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any other specific terms, preferences, rights, limitations or restrictions of
the preferred stock. |
Rank
Unless otherwise indicated in the applicable supplement to this prospectus, shares of our
preferred stock will rank, with respect to payment of distributions and rights upon our
liquidation, dissolution or winding up, and allocation of our earnings and losses:
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senior to all classes or series of our common stock, and to all of our equity
securities ranking junior to the preferred stock; |
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on a parity with all equity securities issued by us, the terms of which
specifically provide that these equity securities rank on a parity with the
preferred stock; and |
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junior to all equity securities issued by us, the terms of which specifically
provide that these equity securities rank senior to the preferred stock. |
Distributions
Subject to any preferential rights of any outstanding stock or series of stock, our preferred
shareholders are entitled to receive distributions, when and as authorized by our board of
directors, out of legally available funds, and share pro rata based on the number of preferred
shares, common stock and other parity equity securities outstanding.
Voting Rights
Unless otherwise indicated in the applicable supplement to this prospectus, holders of our
preferred stock will not have any voting rights.
22
Liquidation Preference
Upon the voluntary or involuntary liquidation, dissolution or winding up of our affairs, then,
before any distribution or payment shall be made to the holders of any common stock or any other
class or series of stock ranking junior to the preferred stock in our distribution of assets upon
any liquidation, dissolution or winding up, the holders of each series of our preferred stock are
entitled to receive, after payment or provision for payment of our debts and other liabilities, out
of our assets legally available for distribution to shareholders, liquidating distributions in the
amount of the liquidation preference per share (set forth in the applicable supplement to this
prospectus), plus an amount, if applicable, equal to all distributions accrued and unpaid thereon
(which shall not include any accumulation in respect of unpaid distributions for prior distribution
periods if the preferred stock does not have a cumulative distribution). After payment of the full
amount of the liquidating distributions to which they are entitled, the holders of preferred stock
will have no right or claim to any of our remaining assets. In the event that, upon our voluntary
or involuntary liquidation, dissolution or winding up, the legally available assets are
insufficient to pay the amount of the liquidating distributions on all of our outstanding preferred
stock and the corresponding amounts payable on all of our stock of other classes or series of
equity security ranking on a parity with the preferred stock in the distribution of assets upon
liquidation, dissolution or winding up, then the holders of our preferred stock and all other such
classes or series of equity security will share ratably in the distribution of assets in proportion
to the full liquidating distributions to which they would otherwise be respectively entitled.
If the liquidating distributions are made in full to all holders of preferred stock, our
remaining assets will be distributed among the holders of any other classes or series of equity
security ranking junior to the preferred stock upon our liquidation, dissolution, or winding up,
according to their respective rights and preferences and in each case according to their respective
number of shares of stock.
Conversion Rights
The terms and conditions, if any, upon which shares of any series of preferred stock are
convertible into other securities will be set forth in the applicable supplement to this
prospectus. These terms will include the amount and type of security into which the shares of
preferred stock are convertible, the conversion price (or manner of calculation thereof), the
conversion period, provisions as to whether conversion will be at the option of the holders of the
preferred stock or us, the events, if any, requiring an adjustment of the conversion price and
provisions, if any, affecting conversion in the event of the redemption of that preferred stock.
Redemption
If so provided in the applicable supplement to this prospectus, our preferred stock will be
subject to mandatory redemption or redemption at our option, in whole or in part, in each case upon
the terms, at the times and at the redemption prices set forth in such supplement to this
prospectus.
23
DESCRIPTION OF DEBT SECURITIES
We may issue debt securities under an indenture between us and a U.S. banking institution, as
the indenture trustee. Each indenture will be subject to, and governed by, the Trust Indenture Act
of 1939, as amended, and we may supplement the indentures from time to time after we execute them.
This prospectus summarizes what we believe to be the material provisions of the forms of
indenture that are attached as exhibits to the registration statement of which this prospectus
forms a part and that are incorporated herein by reference and the debt securities that we may
issue under the forms of indenture. This summary is not complete and may not describe all of the
provisions of the indenture or of any of the debt securities that might be important to you. For
additional information, you should carefully read the forms of indenture that are attached as
exhibits to the registration statement of which this prospectus forms a part and that are
incorporated herein by reference.
When we offer to sell a particular series of debt securities, we will describe the specific
terms of those debt securities in a supplement to this prospectus. The terms of a particular series
of debt securities may differ from the terms described in this prospectus. As a result, we will
indicate in the prospectus supplement whether the general terms in this prospectus apply to a
particular series of debt securities offered. The prospectus supplement also will state whether any
of the terms summarized below do not apply to the debt securities being offered. Accordingly, for a
description of the terms of a particular issue of debt securities, you should carefully read this
prospectus, the applicable prospectus supplement, and the indenture governing such series of debt
securities which will be filed as an exhibit to the registration statement of which this prospectus
forms a part at or prior to the time of the sale of the debt securities.
General
Within the total dollar amount of the shelf registration statement of which this prospectus
forms a part, we may issue an unlimited principal amount of debt securities in separate series. We
may specify a maximum aggregate principal amount for the debt securities of any series. The debt
securities we issue will have terms that are consistent with the indenture applicable to such
series of debt securities. Senior debt securities will be unsecured and unsubordinated obligations
and will rank equal with all our other unsecured and unsubordinated debt. Subordinated debt
securities will be paid only if all payments due under our senior indebtedness, including any
outstanding senior debt securities, have been made.
The indentures might not limit the amount of other debt that we may incur or whether that debt
is senior to the debt securities offered by this prospectus and the applicable prospectus
supplement, and might not contain financial or similar restrictive covenants. The indentures might
not contain any provision to protect holders of debt securities against a sudden or dramatic
decline in our ability to pay our debt.
If debt securities are offered by us, the prospectus supplement will describe the terms of the
debt securities, including the following if applicable to the particular offering:
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the title and form of the debt securities; |
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the offering price of the debt securities; |
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any limit on the aggregate principal amount of the debt securities or the series
of which they are a part; |
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the person or persons to whom any interest on a debt security of the series are
to be paid; |
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the date or dates on which we are required to repay the principal; |
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the rate or rates at which the debt securities will bear interest; |
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the date or dates from which interest will accrue, and the dates on which we are
required to pay interest; |
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the place or places where we are required to pay the principal and any premium
or interest on the debt securities; |
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the terms and conditions on which we may redeem any debt security, if at all; |
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any obligation to redeem or purchase any debt securities, and the terms and
conditions on which we must do so; |
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the denominations in which we may issue the debt securities; |
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the manner in which we will determine the amount of principal of or any premium
or interest on the debt securities; |
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the currency in which we will pay the principal of and any premium or interest
on the debt securities; |
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the principal amount of the debt securities that we will be required to pay upon
declaration of acceleration of their maturity; |
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the amount that will be deemed to be the principal amount for any purpose,
including the principal amount that will be due and payable upon any maturity or
that will be deemed to be outstanding as of any date; |
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the applicability of the provisions described under Defeasance below; |
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if applicable, the terms of any right to convert debt securities into, or
exchange debt securities for, shares of our debt securities, preferred stock or
common stock or other securities or property; |
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whether we will issue the debt securities in the form of one or more global
securities and, if so, the respective depositaries for the global securities and
the terms of the global securities; |
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the subordination provisions that will apply to any subordinated debt
securities; |
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any addition to or change in the events of default applicable to the debt
securities and any change in the right of the trustee or the holders to declare the
principal amount of any of the debt securities due and payable; |
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any addition to or change in the covenants in the indentures; and |
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any other terms of the debt securities not inconsistent with the applicable
indentures. |
We may sell the debt securities at a substantial discount below their stated principal amount.
We will describe generally the U.S. federal income tax considerations, if any, applicable to debt
securities sold at an original issue discount in the prospectus supplement. An original issue
discount security is any debt security sold for less than its face value, and which provides that
the holder cannot receive the full face value if maturity is accelerated. The prospectus supplement
relating to any original issue discount securities will describe the particular provisions relating
to acceleration of the maturity upon the occurrence of an event of default. In addition, we will
describe generally the U.S. federal income tax or other considerations applicable to any debt
securities that are denominated in a currency or unit other than U.S. dollars. You should consult
with your own tax advisor before making a decision to purchase any debt security.
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Conversion and Exchange Rights
The prospectus supplement will describe, if applicable, the terms on which you may convert
debt securities into or exchange them for debt securities, preferred stock and common stock or
other securities or property. The conversion or exchange may be mandatory or may be at your option.
The prospectus supplement will describe how the amount of debt securities, number of shares of
preferred stock and common stock or other securities or property to be received upon conversion or
exchange would be calculated.
Subordination of Subordinated Debt Securities
The indebtedness underlying any subordinated debt securities will be payable only if all
payments due under our senior indebtedness, as defined in the applicable indenture and any
indenture supplement, including any outstanding senior debt securities, have been made. If we
distribute our assets to creditors upon any dissolution, winding-up, liquidation or reorganization
or in bankruptcy, insolvency, receivership or similar proceedings, we must first pay all amounts
due or to become due on all senior indebtedness before we pay the principal of, or any premium or
interest on, the subordinated debt securities. In the event the subordinated debt securities are
accelerated because of an event of default, we may not make any payment on the subordinated debt
securities until we have paid all senior indebtedness or the acceleration is rescinded. If the
payment of subordinated debt securities accelerates because of an event of default, we must
promptly notify holders of senior indebtedness of the acceleration.
If we experience a bankruptcy, dissolution or reorganization, holders of senior indebtedness
may receive more, ratably, and holders of subordinated debt securities may receive less, ratably,
than our other creditors. The indenture for subordinated debt securities may not limit our ability
to incur additional senior indebtedness.
Form, Exchange, and Transfer
We will issue debt securities only in fully registered form, without coupons, and only in
denominations of $1,000 and integral multiples thereof, unless the prospectus supplement provides
otherwise. The holder of a debt security may elect, subject to the terms of the indentures and the
limitations applicable to global securities, to exchange them for other debt securities of the same
series of any authorized denomination and of similar terms and aggregate principal amount.
Holders of debt securities may present them for exchange as provided above or for registration
of transfer, duly endorsed or with the form of transfer duly executed, at the office of the
transfer agent we designate for that purpose. We will not impose a service charge for any
registration of transfer or exchange of debt securities, but we may require a payment sufficient to
cover any tax or other governmental charge payable in connection with the transfer or exchange. We
will name the transfer agent in the prospectus supplement. We may designate additional transfer
agents or rescind the designation of any transfer agent or approve a change in the office through
which any transfer agent acts, but we must maintain a transfer agent in each place where we will
make payment on debt securities.
If we redeem the debt securities, we will not be required to issue, register the transfer of
or exchange any debt security during a specified period prior to mailing a notice of redemption. We
are not required to register the transfer of or exchange of any debt security selected for
redemption, except the unredeemed portion of the debt security being redeemed.
Global Securities
The debt securities may be represented, in whole or in part, by one or more global securities
that will have an aggregate principal amount equal to that of all debt securities of that series.
Each global security will be registered in the name of a depositary identified in the prospectus
supplement. We will deposit the global security with the depositary or a custodian, and the global
security will bear a legend regarding the restrictions on exchanges and registration of transfer.
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No global security may be exchanged in whole or in part for debt securities registered, and no
transfer of a global security in whole or in part may be registered, in the name of any person
other than the depositary or any nominee or successor of the depositary unless:
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the depositary is unwilling or unable to continue as depositary; or |
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the depositary is no longer in good standing under the Exchange Act or other
applicable statute or regulation. |
The depositary will determine how all securities issued in exchange for a global security will
be registered.
As long as the depositary or its nominee is the registered holder of a global security, we
will consider the depositary or the nominee to be the sole owner and holder of the global security
and the underlying debt securities. Except as stated above, owners of beneficial interests in a
global security will not be entitled to have the global security or any debt security registered in
their names, will not receive physical delivery of certificated debt securities and will not be
considered to be the owners or holders of the global security or underlying debt securities. We
will make all payments of principal, premium and interest on a global security to the depositary or
its nominee. The laws of some jurisdictions require that some purchasers of securities take
physical delivery of such securities in definitive form. These laws may prevent you from
transferring your beneficial interests in a global security.
Only institutions that have accounts with the depositary or its nominee and persons that hold
beneficial interests through the depositary or its nominee may own beneficial interests in a global
security. The depositary will credit, on its book-entry registration and transfer system, the
respective principal amounts of debt securities represented by the global security to the accounts
of its participants. Ownership of beneficial interests in a global security will be shown only on,
and the transfer of those ownership interests will be effected only through, records maintained by
the depositary or any such participant.
The policies and procedures of the depositary may govern payments, transfers, exchanges and
others matters relating to beneficial interests in a global security. We and the trustee will
assume no responsibility or liability for any aspect of the depositarys or any participants
records relating to, or for payments made on account of, beneficial interests in a global security.
Payment and Paying Agents
We will be required to pay principal and any premium or interest on a debt security to the
person in whose name the debt security is registered at the close of business on the regular record
date for such interest.
We will be required to pay principal and any premium or interest on the debt securities at the
office of our designated paying agent. Unless the prospectus supplement indicates otherwise, the
corporate trust office of the trustee will be the paying agent for the debt securities.
Any other paying agents we designate for the debt securities of a particular series will be
named in the prospectus supplement. We may designate additional paying agents, rescind the
designation of any paying agent or approve a change in the office through which any paying agent
acts, but we will be required to maintain a paying agent in each place of payment for the debt
securities.
The paying agent will be required to return to us all money we pay to it for the payment of
the principal, premium or interest on any debt security that remains unclaimed for a specified
period. Thereafter, the holder may look only to us for payment, as an unsecured general creditor.
Consolidation, Merger, and Sale of Assets
Under the terms of the forms of indenture, so long as any securities remain outstanding, we
may not consolidate or enter into a share exchange with or merge into any other person, in a
transaction in which we are not
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the surviving corporation, or sell, convey, transfer or lease our properties and assets
substantially as an entirety to any person, unless:
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the successor assumes our obligations under the debt securities and the
indentures; and |
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we meet the other conditions described in the indentures. |
Events of Default
Each of the following constitutes an event of default under the forms of indenture:
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failure to pay the principal of or any premium on any debt security when due; |
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failure to pay any interest on any debt security when due, for more than a
specified number of days past the due date; |
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failure to deposit any sinking fund payment when due; |
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failure to perform any covenant or agreement in the indenture that continues for
a specified number of days after written notice has been given by the trustee or
the holders of a specified percentage in aggregate principal amount of the debt
securities of that series; |
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events of bankruptcy, insolvency or reorganization; and |
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any other event of default specified in the prospectus supplement. |
If an event of default occurs and continues, both the trustee and holders of a specified
percentage in aggregate principal amount of the outstanding securities of that series may declare
the principal amount of the debt securities of that series to be immediately due and payable. The
holders of a majority in aggregate principal amount of the outstanding securities of that series
may rescind and annul the acceleration if all events of default, other than the nonpayment of
accelerated principal, have been cured or waived.
Except for its duties in case of an event of default, the trustee will not be obligated to
exercise any of its rights or powers at the request or direction of any of the holders, unless the
holders have offered the trustee reasonable indemnity. If they provide indemnification, subject to
conditions specified in the applicable indenture, the holders of a majority in aggregate principal
amount of the outstanding securities of any series may direct the time, method and place of
conducting any proceeding for any remedy available to the trustee or exercising any trust or power
conferred on the trustee with respect to the debt securities of that series.
No holder of a debt security of any series may institute any proceeding with respect to the
indentures, or for the appointment of a receiver or a trustee, or for any other remedy, unless:
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the holder has previously given the trustee written notice of a continuing event
of default; |
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the holders of a specified percentage in aggregate principal amount of the
outstanding securities of that series have made a written request upon the trustee,
and have offered reasonable indemnity to the trustee, to institute the proceeding; |
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the trustee has failed to institute the proceeding for a specified period of
time after its receipt of the notification; and |
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the trustee has not received a direction inconsistent with the request within a
specified number of days from the holders of a specified percentage in aggregate
principal amount of the outstanding securities of that series. |
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Modification and Waiver
Under the forms of indenture, we and the trustee may change an indenture without the consent
of any holders with respect to specific matters, including:
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to fix any ambiguity, defect or inconsistency in the indenture; and |
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to change anything that does not materially adversely affect the interests of
any holder of debt securities of any series. |
In addition, under the forms of indenture, the rights of holders of a series of debt
securities may be changed by us and the trustee with the written consent of the holders of at least
a majority in aggregate principal amount of the outstanding debt securities of each series that is
affected. However, we and the trustee may only make the following changes with the consent of the
holder of any outstanding debt securities affected:
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extending the fixed maturity of the series of debt securities; |
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reducing the principal amount, reducing the rate of or extending the time of
payment of interest, or any premium payable upon the redemption, of any debt
securities; or |
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reducing the percentage of debt securities the holders of which are required to
consent to any amendment. |
The holders of a majority in principal amount of the outstanding debt securities of any series
may waive any past default under the forms of indenture with respect to debt securities of that
series, except a default in the payment of principal, premium or interest on any debt security of
that series or in respect of a covenant or provision of the indenture that cannot be amended
without each holders consent.
Except in limited circumstances, we may set any day as a record date for the purpose of
determining the holders of outstanding debt securities of any series entitled to give or take any
direction, notice, consent, waiver or other action under the indentures. In limited circumstances,
the trustee may set a record date. To be effective, the action must be taken by holders of the
requisite principal amount of such debt securities within a specified period following the record
date.
Defeasance
To the extent stated in the prospectus supplement, we may elect to apply the provisions in the
forms of indenture relating to defeasance and discharge of indebtedness, or to defeasance of
restrictive covenants, to the debt securities of any series. The forms of indenture provide that,
upon satisfaction of the requirements described below, we may terminate all of our obligations
under the debt securities of any series and the applicable indenture, known as legal defeasance,
other than our obligation:
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to maintain a registrar and paying agents and hold monies for payment in trust; |
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to register the transfer or exchange of the debt securities; and |
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to replace mutilated, destroyed, lost or stolen debt securities. |
In addition, we may terminate our obligation to comply with any restrictive covenants under
the debt securities of any series or the applicable indenture, known as covenant defeasance.
We may exercise our legal defeasance option even if we have previously exercised our covenant
defeasance option. If we exercise either defeasance option, payment of the debt securities may not
be accelerated because of the occurrence of events of default.
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To exercise either defeasance option as to debt securities of any series, we must irrevocably
deposit in trust with the trustee money and/or obligations backed by the full faith and credit of
the United States that will provide money in an amount sufficient in the written opinion of a
nationally recognized firm of independent public accountants to pay the principal of, premium, if
any, and each installment of interest on the debt securities. We may only establish this trust if,
among other things:
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no event of default shall have occurred or be continuing; |
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in the case of legal defeasance, we have delivered to the trustee an opinion of
counsel to the effect that we have received from, or there has been published by,
the Internal Revenue Service a ruling or there has been a change in law, which in
the opinion of our counsel, provides that holders of the debt securities will not
recognize gain or loss for federal income tax purposes as a result of such deposit,
defeasance and discharge and will be subject to federal income tax on the same
amount, in the same manner and at the same times as would have been the case if
such deposit, defeasance and discharge had not occurred; |
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in the case of covenant defeasance, we have delivered to the trustee an opinion
of counsel to the effect that the holders of the debt securities will not recognize
gain or loss for federal income tax purposes as a result of such deposit,
defeasance and discharge and will be subject to federal income tax on the same
amount, in the same manner and at the same times as would have been the case if
such deposit, defeasance and discharge had not occurred; and |
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we satisfy other customary conditions precedent described in the applicable
indenture. |
Notices
We will be required to mail notices to holders of debt securities as indicated in the
prospectus supplement.
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We may treat the person in whose name a debt security is registered as the absolute owner,
whether or not such debt security may be overdue, for the purpose of making payment and for all
other purposes.
Governing Law
The indentures and the debt securities will be governed by and construed in accordance with
the laws of the State of New York.
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DESCRIPTION OF DEPOSITARY SHARES
We may, at our option, elect to offer fractional shares or some multiple of shares of
preferred stock, rather than individual shares of preferred stock. If we choose to do so, we will
issue depositary receipts for depositary shares, each of which will represent a fraction or a
multiple of a share of a particular series of preferred stock as described below.
The following is a general description of the depositary shares we may issue. The applicable
prospectus supplement will describe the specific terms of any issuance of depositary shares. The
terms of any depositary shares we offer may differ from the terms described in this prospectus. As
a result, we will describe in the prospectus supplement the specific terms of the particular series
of depositary shares offered by that prospectus supplement. Accordingly, for a description of the
terms of a particular series of depositary shares, you should carefully read this prospectus, the
applicable prospectus supplement, the applicable deposit agreement, including the applicable
depositary receipt relating to the depositary shares, which will be filed as an exhibit to a
document incorporated by reference in the registration statement of which this prospectus forms a
part at or prior to the time of the sale of the depositary shares.
General
The shares of any series of preferred stock represented by depositary shares will be deposited
under a deposit agreement among us, a bank or trust company we select, as depositary, which we
refer to as the preferred stock depositary, and the holders from time to time of depositary
receipts issued under the agreement. Subject to the terms of the deposit agreement, each holder of
a depositary share will be entitled, in proportion to the fraction or multiple of a share of
preferred stock represented by that depositary share, to all the rights and preferences of the
preferred stock represented by that depositary share, including dividend, voting and liquidation
rights.
The depositary shares will be evidenced by depositary receipts issued under the deposit
agreement. Depositary receipts will be distributed to those persons purchasing the fractional or
multiple shares of the related series of preferred stock. Immediately following the issuance of
shares of a series of preferred stock, we will be required to deposit those shares with the
preferred stock depositary, which will then be required to issue and deliver the depositary
receipts to the purchasers.
Depositary receipts will only be issued evidencing whole depositary shares. A depositary
receipt may evidence any number of whole depositary shares.
Dividends and Other Distributions
The preferred stock depositary will be required to distribute all cash dividends or other cash
distributions received on the related series of preferred stock to the record holders of depositary
receipts relating to those series in proportion to the number of the depositary shares evidenced by
depositary receipts those holders own.
If we make a distribution other than in cash, the preferred stock depositary will be required
to distribute the property it receives to the record holders of depositary receipts in proportion
to the number of depositary shares evidenced by depositary receipts those holders own, unless the
preferred stock depositary determines that the distribution cannot be made proportionately among
those holders or that it is not feasible to make the distribution. In that event, the preferred
stock depositary may, with our approval, sell the property and distribute the net proceeds to the
holders in proportion to the number of depositary shares evidenced by depositary receipts they own.
The amount distributed to holders of depositary shares will be reduced by any amounts required
to be withheld by us or the preferred stock depositary on account of taxes or other governmental
charges.
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Conversion and Exchange
If any series of preferred stock underlying the depositary shares is subject to conversion or
exchange, the applicable prospectus supplement will describe the rights or obligations of each
record holder of depositary receipts to convert or exchange the depositary shares.
Voting
Upon receiving notice of any meeting at which the holders of any series of the preferred stock
are entitled to vote, the preferred stock depositary will be required to mail the information
contained in the notice of the meeting to the record holders of the depositary receipts relating to
that series of preferred stock. Each record holder of the depositary receipts on the record date,
which will be the same date as the record date for the related series of preferred stock, may
instruct the preferred stock depositary how to exercise his or her voting rights. The preferred
stock depositary will endeavor, insofar as practicable, to vote or cause to be voted the maximum
number of whole shares of the preferred stock represented by those depositary shares in accordance
with those instructions received sufficiently in advance of the meeting, and we will be required to
agree to take all reasonable action that may be deemed necessary by the preferred stock depositary
in order to enable the preferred stock depositary to do so. The preferred stock depositary will be
required to abstain from voting shares of the preferred stock for which it does not receive
specific instructions from the holder of the depositary shares representing them.
Redemption of Depositary Shares
Depositary shares will be redeemed from any proceeds received by the preferred stock
depositary resulting from the redemption, in whole or in part, of the series of the preferred stock
represented by those depositary shares. The redemption price per depositary share will equal the
applicable fraction or multiple of the redemption price per share payable with respect to the
series of the preferred stock. If we redeem shares of a series of preferred stock held by the
preferred stock depositary, the preferred stock depositary will be required to redeem as of the
same redemption date the number of depositary shares representing the shares of preferred stock
that we redeem. If less than all the depositary shares will be redeemed, the depositary shares to
be redeemed would be selected by lot or substantially equivalent method determined by the preferred
stock depositary.
After the date fixed for redemption, the depositary shares called for redemption will no
longer be deemed to be outstanding, and all rights of the holders of the depositary shares will
cease, except the right to receive the monies payable and any other property to which the holders
were entitled upon the redemption upon surrender to the preferred stock depositary of the
depositary receipts evidencing the depositary shares. Any funds deposited by us with the preferred
stock depositary for any depositary shares that the holders fail to redeem will be returned to us
after a period of two years from the date the funds are deposited.
Amendment and Termination of the Deposit Agreement
We may amend the form of depositary receipt evidencing the depositary shares and any provision
of the deposit agreement at any time and from time to time by agreement with the preferred stock
depositary. However, any amendment that materially and adversely alters the rights of the holders
of depositary receipts will not be effective unless it has been approved by the holders of at least
a majority of the depositary shares then outstanding. The deposit agreement will automatically
terminate after there has been a final distribution on the related series of preferred stock in
connection with our liquidation, dissolution or winding up and that distribution has been made to
the holders of depositary shares or all of the depositary shares have been redeemed.
Charges of Preferred Stock Depositary
We will be required to pay all transfer and other taxes and governmental charges arising
solely from the existence of the depositary arrangements. We will be required to pay all charges of
the preferred stock depositary in connection with the initial deposit of the related series of
preferred stock, the initial issuance of the depositary shares, all withdrawals of shares of the
related series of preferred stock by holders of depositary shares and the registration of transfers
of title to any depositary shares.
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However, holders of depositary shares will be required to pay other transfer and other taxes
and governmental charges and the other charges expressly provided in the deposit agreement to be
for their accounts.
Corporate Trust Office of Preferred Stock Depositary
The preferred stock depositarys corporate trust office will be set forth in the applicable
prospectus supplement relating to a series of depositary shares. The preferred stock depositary
will act as transfer agent and registrar for depositary receipts, and, if shares of a series of
preferred stock are redeemable, the preferred stock depositary will act as redemption agent for the
corresponding depositary receipts.
Resignation and Removal of Preferred Stock Depositary
The preferred stock depositary may resign at any time by delivering to us written notice of
its election to do so, and we may at any time remove the preferred stock depositary. Any
resignation or removal will take effect upon the appointment of a successor preferred stock
depositary. A successor must be appointed by us within 60 days after delivery of the notice of
resignation or removal and must be a bank or trust company.
Reports to Holders
We will be required to deliver all required reports and communications to holders of the
preferred stock to the preferred stock depositary, and it will be required to forward those reports
and communications to the holders of depositary shares. Upon request, the preferred stock
depositary will be required to provide for inspection to the holders of depositary shares the
transfer books of the depositary and the list of holders of receipts; provided that any requesting
holder certifies to the preferred stock depositary that such inspection is for a proper purpose
reasonably related to such persons interest as an owner of depositary shares evidenced by the
receipts.
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DESCRIPTION OF WARRANTS
We may issue warrants from time to time in one or more series for the purchase of our common
stock, debt securities or preferred stock or any combination of those securities. Warrants may be
issued independently or together with any shares of common stock, shares of preferred stock,
depositary shares, or debt securities offered by any prospectus supplement and may be attached to
or separate from common stock, preferred stock, depositary shares, or debt securities. Each series
of warrants will be issued under a separate warrant agreement to be entered into between us and a
warrant agent, or any other bank or trust company specified in the related prospectus supplement
relating to the particular issue of warrants. The warrant agent will act as our agent in connection
with the warrants and will not assume any obligation or relationship of agency or trust for or with
any holders of warrants or beneficial owners of warrants. The specific terms of a series of
warrants will be described in the applicable prospectus supplement relating to that series of
warrants along with any general provisions applicable to that series of warrants.
The following is a general description of the warrants we may issue. The applicable prospectus
supplement will describe the specific terms of any issuance of warrants. The terms of any warrants
we offer may differ from the terms described in this prospectus. As a result, we will describe in
the prospectus supplement the specific terms of the particular series of warrants offered by that
prospectus supplement. Accordingly, for a description of the terms of a particular series of
warrants, you should carefully read this prospectus, the applicable prospectus supplement, the
applicable warrant agreement, which will be filed as an exhibit to a the registration statement of
which this prospectus forms a part.
Terms
If warrants are offered by us, the prospectus supplement will describe the terms of the
warrants, including the following if applicable to the particular offering:
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the title of the warrants; |
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the total number of warrants; |
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the currency, currencies, including composite currencies or currency units, in
which the price of the warrants may be payable; |
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the number of shares of common stock purchasable upon exercise of the warrants
to purchase common stock and the price at which such shares of common stock may be
purchased upon exercise; |
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the designation, aggregate principal amount, currency, currencies or currency
units and terms of the debt securities purchasable upon exercise of the warrants
and the price at which the debt securities may be purchased upon such exercise; |
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the designation and terms of the preferred stock, depositary shares, or debt
securities with which the warrants are issued and the number of warrants issued
with each share of preferred stock, depositary share, or debt security; |
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the date on and after which the warrants and the related common stock, preferred
stock, depositary shares, or debt securities will be separately transferable; |
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if applicable, the date on which the right to exercise the warrants shall
commence and the date on which this right shall expire; |
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if applicable, the minimum or maximum amount of the warrants which may be
exercised at any one time; |
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a discussion of federal income tax, accounting and other special considerations,
procedures and limitations relating to the warrants; and |
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any other terms of the warrants including terms, procedures and limitations
relating to the exchange and exercise of the warrants. |
Warrants may be exchanged for new warrants of different denominations, may be presented for
registration of transfer, and may be exercised at the corporate trust office of the warrant agent
or any other office indicated in the prospectus supplement. Before the exercise of their warrants,
holders of warrants will not have any of the rights of holders of shares of common stock, shares of
preferred stock, depositary shares, or debt securities purchasable upon exercise, including the
right to receive payments of principal of, any premium on, or any interest on, the debt securities
purchasable upon such exercise or to enforce the covenants in the indenture or to receive payments
of dividends, if any, on the shares common stock, preferred stock, or depositary shares purchasable
upon such exercise or to exercise any applicable right to vote.
Exercise of Warrants
Each warrant will entitle the holder to purchase a principal amount of debt securities or a
number of shares of common stock, shares of preferred stock, or depositary shares at an exercise
price as shall in each case be set forth in, or calculable from, the prospectus supplement relating
to those warrants. Warrants may be exercised at the times set forth in the prospectus supplement
relating to such warrants. After the close of business on the expiration date (or any later date to
which the expiration date may be extended by us), unexercised warrants will become void. Subject to
any restrictions and additional requirements that may be set forth in the prospectus supplement
relating thereto, warrants may be exercised by delivery to the warrant agent of the certificate
evidencing the warrants properly completed and duly executed and of payment as provided in the
prospectus supplement of the amount required to purchase the debt securities or shares of common
stock, shares of preferred stock, or depositary shares purchasable upon such exercise. The exercise
price will be the price applicable on the date of payment in full, as set forth in the prospectus
supplement relating to the warrants. Upon receipt of the payment and the certificate representing
the warrants to be exercised properly completed and duly executed at the corporate trust office of
the warrant agent or any other office indicated in the prospectus supplement, we will, as soon as
practicable, issue and deliver the debt securities or shares of common stock, shares of preferred
stock, or depositary shares purchasable upon such exercise. If fewer than all of the warrants
represented by that certificate are exercised, a new certificate will be issued for the remaining
amount of warrants.
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PLAN OF DISTRIBUTION
We may sell securities to one or more underwriters or dealers for public offering and sale by
them, or we may sell the securities to investors directly or through agents. The applicable
prospectus supplement will set forth the terms of the offering and the method of distribution and
will identify any firms acting as underwriters, dealers or agents in connection with the offering,
including, if applicable to the particular offering:
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the name or names of any underwriters; |
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the purchase price of the securities; |
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any underwriting discounts and other items constituting underwriters
compensation; |
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any public offering price and the net proceeds we will receive from such sale; |
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any discounts or concessions allowed or reallowed or paid to dealers; and |
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any securities exchange or market on which the securities offered in the
prospectus supplement may be listed. |
We may distribute our securities from time to time in one or more transactions at a fixed
price or prices, which may be changed, or at prices determined as the prospectus supplement
specifies, including in at-the-market offerings. We may sell our securities through a rights
offering, forward contracts, or similar arrangements.
We may authorize underwriters, dealers, or agents to solicit offers by certain purchasers to
purchase the securities from us at the public offering price set forth in the prospectus supplement
pursuant to delayed delivery contracts providing for payment and delivery on a specified date in
the future. The contracts will be subject only to those conditions set forth in the applicable
prospectus supplement, and the prospectus supplement will set forth any commissions we pay for
solicitation of these contracts.
Any underwriting discounts or other compensation which we pay to underwriters or agents in
connection with the offering of our securities, and any discounts, concessions or commissions which
underwriters allow to dealers, will be set forth in the prospectus supplement. Underwriters may
sell our securities to or through dealers, and such dealers may receive compensation in the form of
discounts, concessions or commissions from the underwriters and commissions from the purchasers for
whom they may act as agents. Underwriters, dealers and agents that participate in the distribution
of our securities may be deemed to be underwriters under the Securities Act and any discounts or
commissions they receive from us and any profit on the resale of our securities they realize may be
deemed to be underwriting discounts and commissions under the Securities Act. Any such underwriter
or agent will be identified, and any such compensation received from us, will be described in the
applicable supplement to this prospectus. Unless otherwise set forth in the supplement to this
prospectus relating thereto, the obligations of the underwriters or agents to purchase our
securities will be subject to conditions precedent and the underwriters will be obligated to
purchase all our offered securities if any are purchased. The public offering price and any
discounts or concessions allowed or reallowed or paid to dealers may be changed from time to time.
Any common stock sold pursuant to this prospectus and applicable prospectus supplement will be
approved for trading, upon notice of issuance, on the Nasdaq Global Market or such other stock
exchange that our securities are trading upon.
Underwriters and their controlling persons, dealers and agents may be entitled, under
agreements entered into with us, to indemnification against and contribution toward specific civil
liabilities, including liabilities under the Securities Act.
The securities being offered under this prospectus, other than our common stock, will be new
issues of securities with no established trading market and unless otherwise specified in the
applicable prospectus supplement. It has not presently been established whether the underwriters,
if any, as identified in a prospectus supplement, will
36
make a market in the securities. If the underwriters make a market in the securities, the market
making may be discontinued at any time without notice. We cannot provide any assurance as to the
liquidity of the trading market for the securities.
An underwriter may engage in over-allotment, stabilizing transactions, short covering
transactions and penalty bids in accordance with the securities laws. Over-allotment involves sales
in excess of the offering size, which creates a short position. Stabilizing transactions permit
bidders to purchase the underlying security so long as the stabilizing bids do not exceed a
specified maximum. Short covering transactions involve purchases of the securities in the open
market after the distribution is completed to cover short positions. Penalty bids permit the
underwriters to reclaim a selling concession from a dealer when the securities originally sold by
the dealer are purchased in a covering transaction to cover short positions. Those activities may
cause the price of the securities to be higher than it would otherwise be. The underwriters may
engage in these activities on any exchange or other market in which the securities may be traded.
If commenced, the underwriters may discontinue these activities at any time.
Certain of the underwriters and their affiliates may be customers of, engage in transactions
with, and perform services for, us in the ordinary course of business.
LEGAL MATTERS
Legal matters with respect to the validity of the securities offered under this prospectus and
any supplement hereto will be passed upon for us by Reed Smith LLP. Counsel for any underwriter or
agents will be noted in the applicable prospectus supplement.
EXPERTS
The consolidated financial statements, incorporated in this prospectus by reference from DUSA
Pharmaceuticals, Inc.s Annual Report on Form 10-K and the effectiveness of DUSA Pharmaceuticals,
Inc.s internal control over financial reporting have been audited by Deloitte & Touche LLP, an
independent registered public accounting firm, as stated in their reports, which are incorporated
herein by reference. Such financial statements have been so incorporated in reliance upon the
reports of such firm given upon their authority as experts in accounting and auditing.
WHERE YOU CAN FIND MORE INFORMATION
We file annual, quarterly and current reports, proxy statements and other information with the
SEC in Washington, D.C. You may read and copy any document we file at the SECs public reference
facilities maintained by the SEC at 100 F Street, N.E., Washington, D.C. 20549. The SEC has
prescribed rates for copying. Please call the SEC at 1-800-SEC-0330 for further information on the
public reference room. Our SEC filings are also available to the public at the SECs website at
http://www.sec.gov. Our filings are also available at our website at http://www.dusapharma.com,
which is not a part of this prospectus and is not incorporated herein by reference.
Our reports and other information can also be inspected at the offices of the National
Association of Securities Dealers at 1735 K Street, N.W., Washington, D.C. 20006-1506.
This prospectus is part of a registration statement that we filed with the SEC. This
prospectus and any subsequent prospectus supplements do not contain all of the information in the
registration statement as permitted by the rules and regulations of the SEC. You can obtain a copy
of the registration statement from the SEC at the address listed above or from the SECs website
listed above.
37
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The SEC allows us to incorporate by reference some of the documents we file with it into
this prospectus, which means:
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we can disclose important information to you by referring you to those
documents; |
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the information incorporated by reference is considered to be part of this
prospectus; and |
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later information that we file with the SEC will automatically update and
supersede the incorporated information. |
The following documents, which have been filed by us with the SEC pursuant to the Exchange Act
are incorporated by reference in this registration statement as of their respective dates:
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Our Annual Report on Form 10-K for the year ended December 31, 2007; |
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Our Quarterly Report on Form 10-Q for the period ended March 31, 2008; |
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Our Current Reports on Form 8-K filed with the SEC on January 18, 2008,
January 31, 2008, March 6, 2008, April 21, 2008, and April 29, 2008; |
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All other reports filed pursuant to Section 13 or 15(d) of the Exchange Act
since December 31, 2007; |
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The description of DUSAs common stock contained in its registration statement
on Form 8-A which was filed on January 3, 1992 and amended on Form 8-A12G filed on
October 24, 1997, and in DUSAs Quarterly Report on Form 10-Q for the quarter
ended September 30, 1997 which was filed on November 12, 1997; and |
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The description of DUSAs Series A Junior Participating Preferred Stock
contained in its registration statement on Form 8-A12B which was filed on November
7, 2002. |
All documents filed by us pursuant to Section 13(a), 13(c), 14 and 15(d) of the Exchange Act
after the date hereof and prior to the termination of the offering, other than information
furnished pursuant to Item 2.02 or Item 7.01 of Form 8-K or as otherwise permitted by SEC rules and
regulations, shall be deemed to be incorporated by reference into this registration statement and
to be a part hereof from the date of filing of such documents. Any statement contained in a
document incorporated or deemed to be incorporated herein by reference shall be deemed to be
modified or superseded for purposes of this prospectus to the extent that a statement contained
herein or in any other subsequently filed document which also is or is deemed to be incorporated by
reference herein modifies or supersedes such statement.
We will provide each person, including any beneficial owner, to whom a prospectus is
delivered, a copy of any or all of the information that has been incorporated by reference in this
prospectus, but not delivered with this prospectus. We will provide such copies at no cost, upon
written or oral request, by writing or telephoning us at:
DUSA Pharmaceuticals, Inc.
25 Upton Drive
Wilmington, Massachusetts 01887
Attention: Ms. Shari Lovell
Telephone: (978) 657-7500
E-mail to: lovells@DusaPharma.com
38
We maintain a website at http://www.dusapharma.com, which is not a part of this prospectus and
is not incorporated herein by reference.
This prospectus is part of a registration statement on Form S-3 that we filed with the SEC.
You should rely only on the information and representations provided in this prospectus or on the
information 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 not assume that the information in this prospectus is
accurate as of any date other than the date on the front of this document.
39
$75,000,000
DUSA
PHARMACEUTICALS, INC.
Common Stock, Preferred Stock, Debt Securities,
Depositary Shares and Warrants
40
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION
The following is a statement of the estimated costs and expenses, other than underwriting
compensation, incurred or expected to be incurred by us in connection with the issuance and
distribution of an assumed amount of $75,000,000 of securities being registered pursuant to this
registration statement. The assumed amount has been used to demonstrate the costs and expenses of
an offering of the entire assumed amount of securities being registered and does not represent an
estimate of the amount of securities that may be offered because such amount is unknown at this
time. All amounts except the SEC registration fee are estimated.
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SEC Registration Fee |
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$ |
2,947.50 |
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NASDAQ Listing Fee |
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$ |
65,000.00 |
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Printing and Engraving |
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$ |
30,000.00 |
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Accounting Fees and Expenses |
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$ |
30,000.00 |
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Legal Fees and Expenses |
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$ |
100,000.00 |
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Miscellaneous Expenses |
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2,052.50 |
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TOTAL |
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$ |
230,000.00 |
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Item 15. INDEMNIFICATION OF DIRECTORS AND OFFICERS
Article 5 of our certificate of incorporation, as amended, and New Jersey Business Corporation
Act, N.J.S.A. 14A:2-7 provide as follows:
Any director and officer of the Corporation shall not be personally liable to the
Corporation or its shareholders for damages for breach of any duty owed to the
Corporation or its shareholders, except that this provision shall not relieve a
director or officer from liability for any breach of duty based upon an act or
omission (a) in breach of such persons duty of loyalty to the Corporation or its
shareholders; (b) not in good faith or involving a knowing violation of law; or (c)
resulting in receipt by such person of an improper personal benefit.
Our bylaws, as amended, pursuant to New Jersey Business Corporation Act, N.J.S.A. 14A:3-5,
provide as follows:
ARTICLE IV
INDEMNIFICATION
Section 1. Actions by Others. The Corporation (1) shall indemnify any person
who was or is a party or is threatened to be made a party to any threatened, pending or completed
action, suit or proceeding, whether civil, criminal, administrative or investigative (other than an
action by or in the right of the Corporation) by reason of the fact that he is or was a director,
officer or trustee of the Corporation or of any constituent corporation absorbed by the Corporation
in a consolidation or merger and (2) except as otherwise required by Section 3 of this Article, may
indemnify any person who was or is a party or is threatened to be made a party to any threatened,
pending or completed action, suit or proceeding, whether civil, criminal, administrative or
investigative (other than an action by or in the right of the Corporation) by reason of the fact
that he (a) is or was an employee or agent or the legal representative of a director, officer,
trustee, employee or agent of the Corporation or of any absorbed constituent corporation, or (b) is
or was serving at the request of the Corporation or of any absorbed constituent corporation as a
director, officer, employee, agent of or participant in another corporation, partnership, joint
venture, trust or other enterprise, or the legal representative of such a person against expenses,
costs, disbursements (including attorneys fees), judgments, fines and amounts actually and
reasonably incurred by him in good faith and in connection with
II-1
such action, suit or proceeding if he acted in a manner he reasonably believed to be in or not
opposed to the best interests of the Corporation, and with respect to any criminal action or
proceeding, he had no reasonable cause to believe that his conduct was unlawful. The termination of
any action, suit or proceeding by judgment, order, settlement, conviction, or upon a plea of nolo
contendere or its equivalent, shall not, of itself, create a presumption that the person did not
meet the applicable standard of conduct.
Section 2. Actions by or in the Right of the Corporation. The Corporation
shall indemnify any person who was or is a party or is threatened to be made a party to any
threatened, pending or completed action or suit by or in the right of the Corporation to procure a
judgment in its favor by reason of the fact that he is or was a director, officer, trustee,
employee or agent of the Corporation or of any constituent corporation absorbed by the Corporation
by consolidation or merger, or the legal representative of any such person, or is or was serving at
the request of the Corporation or of any absorbed constituent corporation, as a director, officer,
trustee, employee, agent of or participant, or the legal representative of any such person in
another corporation, partnership, joint venture, trust or other enterprise against expenses
(including attorneys fees) actually and reasonably incurred by him in connection with the defense
or settlement of such action or suit if he acted in good faith and in a manner he reasonably
believed to be in or not opposed to the best interests of the Corporation and except that no
indemnification shall be made in respect of any claim, issue or matter as to which such person
shall have been adjudged to be liable to the Corporation unless and only to the extent that the New
Jersey Superior Court or the court in which such action or suit was brought shall determine upon
application that, despite the adjudication of liability but in view of all the circumstances of the
case, such person is fairly and reasonably entitled to indemnity for such expenses which the New
Jersey Superior Court or such other court shall deem proper.
Section 3. Successful Defense. To the extent that a person who is or was a
director, officer, trustee, employee or agent of the Corporation or of any constituent corporation
absorbed by the Corporation by consolidation or merger, or the legal representative of any such
person, has been successful on the merits or otherwise in defense of any action, suit or proceeding
referred to in Section 1 or Section 2 of this Article, or in defense of any claim, issue, or matter
therein, he shall be indemnified against expenses (including attorneys fees) actually and
reasonably incurred by him in connection therewith.
Section 4. Specific Authorization. Any indemnification under Section 1 or
Section 2 of this Article (unless ordered by a court) shall be made by the Corporation only as
authorized in the specific case upon a determination that indemnification of the director, officer,
trustee, employee, agent, or the legal representative thereof, is proper in the circumstances
because he has met the applicable standard of conduct set forth in said Sections 1 and 2. Such
determination shall be made (1) by the Board of Directors by a majority vote of quorum consisting
of directors who were not parties to such action, suit or proceeding, or (2) if such a quorum is
not obtainable, a quorum of disinterested directors so directs, by independent legal counsel for a
written opinion, (3) by the shareholders.
Section 5. Advance of Expenses. Expenses incurred by any person who may have
a right of indemnification under this Article in defending civil or criminal action, suit or
proceeding may be paid by the Corporation in advance of the final distribution of such action, suit
or proceeding as authorized by the board of directors upon receipt of an undertaking by or on
behalf of the director, officer, trustee, employee, or the legal representative thereof, to repay
such amount unless it shall ultimately be determined that he is entitled to be indemnified by the
Corporation pursuant to this Article.
Section 6. Right of Indemnity not Exclusive. The indemnification and
advancement of expenses provided by this Article shall not exclude any other rights to which those
seeking indemnification may be entitled under the certificate of incorporation of the Corporation
or any by-law, agreement, vote of shareholders or otherwise; provided that no indemnification shall
be made to or on behalf of a Director, officer, trustee, employee, agent, or legal representative
if a judgment or other final adjudication adverse to such persons establishes that his acts or
omissions (a) were in breach of his duty of loyalty to the corporation or its shareholders, (b)
were not in good faith or involved a knowing violation of law or (c) resulted in receipt by such
person of an improper personal benefit.
Section 7. Insurance. The Corporation may purchase and maintain insurance on
behalf of any person who is or was a director, officer, trustee, employee or agent of the
Corporation or of any constituent
II-2
corporation absorbed by the Corporation by consolidation or merger of the legal representative
of such person or is or was serving at the request of the Corporation or of any absorbed
constituent corporation as a director, officer, trustee, employee or agent of or participant in
another corporation, partnership, joint venture, trust or other enterprise, or the legal
representative of any such person against any liability asserted against him and incurred by him in
any such capacity, arising out of his status as such or by reason of his being or having been such,
whether or not the Corporation would have the power to indemnify him against such liability under
the provisions of this Article, the New Jersey Business Corporation Act, or otherwise.
Section 8. Invalidity of any Provision of this Article. The invalidity or
unenforceability of any provision of this Article shall not affect the validity or enforceability
of the remaining provisions of this Article.
We also maintain directors and officers liability insurance which may, in some instances,
reimburse us for judgments against us or our directors or officers.
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Item 16. EXHIBITS
(a) Exhibits:
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Exhibit No. |
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Description of Exhibit |
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1.1
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Form of Underwriting Agreement.* |
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3.1
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Certificate of Incorporation, as amended, filed as Exhibit 3(a) to the Registrants Form 10-K for the fiscal year ended December
31, 1998, and is incorporated herein by reference. |
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3.2
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Certificate of Amendment to the Certificate of Incorporation, as amended, dated October 28, 2002 and filed as Exhibit 99.3 to the
Registrants Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2002, filed November 12, 2002, and is
incorporated herein by reference. |
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3.3
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By-laws of the Registrant, filed as Exhibit 3.1 to the Registrants current report on Form 8-K, filed on November 2, 2007, and is
incorporated herein by reference. |
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3.4
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Certificate of Amendment to Certificate of Incorporation designating the terms of preferred stock.* |
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4.1
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Common Stock specimen, filed as Exhibit 4(a) to the Registrants Form 10-K for the fiscal year ended December 31, 2002, and is
incorporated herein by reference. |
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4.2
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Specimen of Preferred Stock Certificate.* |
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4.3
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Form of Indenture for Senior Debt Securities (Form of Senior Debt Securities included therein). |
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4.4
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Form of Indenture for Subordinated Debt Securities (Form of Subordinated Debt Securities included therein). |
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4.5
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Form of Deposit Agreement (Form of Receipt included therein).* |
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4.6
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Form of Warrant Agreement (Form of Warrant included therein).* |
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4.7
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Rights Agreement, dated as of September 27, 2002, between the Registrant and American Stock Transfer and Trust Company filed as
Exhibit 4.0 to Registrants Current Report on Form 8-K filed October 11, 2002, and is incorporated herein by reference. |
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4.8
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Rights Certificate relating to the rights granted to holders of common stock under the Rights Agreement filed as Exhibit 4.0 to
Registrants Current Report on Form 8-K, filed on
October 11, 2002, and is incorporated herein by reference. |
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5.1
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Opinion of Reed Smith LLP. |
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12.1
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Statement regarding Computation of Ratios of Earnings to Fixed Charges and Earnings to Combined Fixed Charges and Preferred Stock
Dividends. |
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23.1
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Consent of Independent Registered Public Accounting Firm. |
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23.2
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Consent of Reed Smith LLP. |
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24.1
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Power of Attorney (included in the signature pages hereto). |
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25.1
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Statement of Eligibility and Qualification of Trustee on Form T-1 under Trust Indenture Act of 1939, as amended, for debt
securities indenture.* |
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* |
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To be filed, as applicable, by amendment or as an exhibit to a document to be incorporated by
reference herein in connection with an offering of the securities registered. |
II-4
Item 17. UNDERTAKINGS
(a) The undersigned registrant hereby undertakes:
(1)
To file, during any period in which offers or sales are being made, a post-effective
amendment to this registration statement:
(i) To include any prospectus required by Section 10(a)(3) of the Securities Act of
1933 (the Securities Act);
(ii) To reflect in the prospectus any facts or events arising after the effective date
of this 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 this 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 a prospectus filed with the Securities and
Exchange Commission (the SEC) pursuant to Rule 424(b) if, in the aggregate, the changes in
volume and price represent no more than a 20% change in the maximum aggregate offering price
set forth in the Calculation of Registration Fee table in the effective registration
statement; and
(iii) To include any material information with respect to the plan of distribution not
previously disclosed in this registration statement or any material change to such information
in this registration statement;
provided, however, that paragraphs (a)(1)(i), (a)(i)(ii) and (a)(1)(iii) above do not apply if
information required to be included in a post-effective amendment by those paragraphs is contained
in periodic reports filed with or furnished to the SEC by the registrant pursuant to Section 13 or
Section 15(d) of the Securities Exchange Act of 1934 (the Exchange Act) that are incorporated by
reference in the registration statement or is contained in a form of prospectus filed pursuant to
Rule 424(b) that is part of the registration statement;
(2) That, for the purpose of determining any liability under the Securities Act, each such
post-effective amendment shall be deemed to be a new registration statement relating to the
securities offered therein, and the offering of such securities at that time shall be deemed to be
the initial bona fide offering thereof.
(3) To remove from registration by means of a post-effective amendment any of the securities
being registered which remain unsold at the termination of the offering.
(5) That, for the purpose of determining liability under the Securities Act to any
purchaser:
(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 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.
(6) That, for the purpose of determining liability of the registrant under the Securities
Act to any purchaser in the initial distribution of the securities, the undersigned registrant
undertakes that in a primary offering of securities of the undersigned registrant pursuant to this
registration statement, regardless of the underwriting method used to sell the securities to the
purchaser, if the securities are offered or sold to such purchaser by means of any of the
II-5
following communications, the undersigned registrant will be a seller to the purchaser and
will be considered to offer or sell such securities to such purchaser:
(i). Any preliminary prospectus or prospectus of the undersigned registrant relating
to the offering required to be filed pursuant to Rule 424;
(ii). Any free writing prospectus relating to the offering prepared by or on behalf
of the undersigned registrant or used or referred to by the undersigned registrant;
(iii). The portion of any other free writing prospectus relating to the offering
containing material information about the undersigned registrant or its securities provided by
or on behalf of the undersigned registrant; and
(iv). Any other communication that is an offer in the offering made by the
undersigned registrant to the purchaser.
(b) The undersigned registrant hereby undertakes that, for purposes of determining any liability
under the Securities Act, each filing of the registrants annual report pursuant to Section 13(a)
or Section 15(d) of the Exchange Act that is incorporated by reference in the registration
statement shall be deemed to be a new registration statement relating to the securities offered
therein, the offering of such securities at that time shall be deemed to be the initial bona fide
offering thereof.
(h) Insofar as indemnification for liabilities arising under the Securities Act may be permitted
to directors, officers and controlling persons of the registrant pursuant to the foregoing
provisions, or otherwise, the registrant has been advised that in the opinion of the SEC such
indemnification is against public policy as expressed in the Securities Act and is, therefore,
unenforceable. In the event that a claim for indemnification against such liabilities (other than
the payment by the registrant of expenses incurred or paid by a director, officer or controlling
person of the registrant in the successful defense of any action, suit or proceeding) is asserted
by such director, officer or controlling person in connection with the securities being registered,
the registrant will, unless in the opinion of its counsel the matter has been settled by
controlling precedent, submit to a court of appropriate jurisdiction the question whether such
indemnification by it is against public policy as expressed in the Securities Act and will be
governed by the final adjudication of such issue.
(j) The undersigned registrant hereby undertakes to file an application for the purpose of
determining the eligibility of the trustee to act under subsection (a) of Section 310 of the Trust
Indenture Act in accordance with the rules and regulations prescribed by the Commission under
Section 305(b)(2) of the Act.
II-6
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 Wilmington, Commonwealth of Massachusetts, USA, on May
16, 2008.
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DUSA PHARMACEUTICALS, INC.
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By: |
/s/ Robert F. Doman
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Robert F. Doman, |
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President and Chief Executive Officer |
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SIGNATURES AND POWER OF ATTORNEY
Know All Men By These Presents, that each person whose signature appears below constitutes and
appoints Robert F. Doman and Richard C. Christopher, and each of them singly, as his true and
lawful attorney-in-fact and agent with full power of substitution and resubstitution, for him and
in his name, place and stead, in any and all capacities, to sign any or all amendments (including
any pre-effective or post-effective amendments) to this registration statement or any related
registration statement that is to be effective upon filing pursuant to Rule 462(b), and to file the
same, with all exhibits thereto, and other documents in connection therewith, with the Securities
and Exchange Commission, granting unto said attorney-in-fact and agent full power and authority to
do and perform each and every act and thing requisite and necessary to be done in connection with
the above premises, as fully to all intents and purposes as he might or could do in person, hereby
ratifying and confirming all that said attorney-in-fact and agent or his substitute or substitutes,
may lawfully do or cause to be done by virtue thereof.
Pursuant to the requirements of the Securities Act of 1933, as amended, this Registration
Statement has been signed by the following persons in the capacities and on the dates indicated:
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/s/ John H. Abeles
John H. Abeles
|
|
Director
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|
Dated: May 16, 2008 |
|
|
|
|
|
/s/ David Bartash
David Bartash
|
|
Director
|
|
Dated: May 16, 2008 |
|
|
|
|
|
/s/ Richard C. Christopher
Richard C. Christopher
|
|
Vice President, Finance and Chief
Financial Officer (principal financial
officer and principal accounting
officer)
|
|
Dated: May 16, 2008 |
|
|
|
|
|
/s/ Robert F. Doman
Robert F. Doman
|
|
Director, President and Chief
Executive Officer (principal executive officer)
|
|
Dated: May 16, 2008 |
|
|
|
|
|
/s/ Jay M. Haft, Esq.
Jay M. Haft, Esq.
|
|
Vice-Chairman of the Board and Director
|
|
Dated: May 16, 2008 |
|
|
|
|
|
/s/ Richard C. Lufkin
Richard C. Lufkin
|
|
Director
|
|
Dated: May 16, 2008 |
|
|
|
|
|
/s/ Magnus Moliteus
Magnus Moliteus
|
|
Director
|
|
Dated: May 16, 2008 |
|
|
|
|
|
/s/ D. Geoffrey Shulman, MD, FRCPC
D. Geoffrey Shulman, MD, FRCPC
|
|
Director and Chairman of the Board
and Chief Strategic Officer
|
|
Dated: May 16, 2008 |
INDEX TO EXHIBITS
(a) Exhibits:
|
|
|
Exhibit No. |
|
Description of Exhibit |
|
|
|
1.1
|
|
Form of Underwriting Agreement.* |
|
|
|
3.1
|
|
Certificate of Incorporation, as amended, filed as Exhibit 3(a) to the Registrants Form 10-K for the fiscal year ended December
31, 1998, and is incorporated herein by reference. |
|
|
|
3.2
|
|
Certificate of Amendment to the Certificate of Incorporation, as amended, dated October 28, 2002 and filed as Exhibit 99.3 to the
Registrants Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2002, filed November 12, 2002, and is
incorporated herein by reference. |
|
|
|
3.3
|
|
By-laws of the Registrant, filed as Exhibit 3.1 to the Registrants current report on Form 8-K, filed on November 2, 2007, and is
incorporated herein by reference. |
|
|
|
3.4
|
|
Certificate of Amendment to Certificate of Incorporation designating the terms of preferred stock.* |
|
|
|
4.1
|
|
Common Stock specimen, filed as Exhibit 4(a) to the Registrants Form 10-K for the fiscal year ended December 31, 2002, and is
incorporated herein by reference. |
|
|
|
4.2
|
|
Specimen of Preferred Stock Certificate.* |
|
|
|
4.3
|
|
Form of Indenture for Senior Debt Securities (Form of Senior Debt Securities included therein). |
|
|
|
4.4
|
|
Form of Indenture for Subordinated Debt Securities (Form of Subordinated Debt Securities included therein). |
|
|
|
4.5
|
|
Form of Deposit Agreement (Form of Receipt included therein).* |
|
|
|
4.6
|
|
Form of Warrant Agreement (Form of Warrant included therein).* |
|
|
|
4.7
|
|
Rights Agreement, dated as of September 27, 2002, between the Registrant and American Stock Transfer and Trust Company filed as
Exhibit 4.0 to Registrants Current Report on Form 8-K filed October 11, 2002, and is incorporated herein by reference. |
|
|
|
4.8
|
|
Rights Certificate relating to the rights granted to holders of common stock under the Rights Agreement filed as Exhibit 4.0 to
Registrants Current Report on Form 8-K, filed on October 11, 2002, and is incorporated herein by reference. |
|
|
|
5.1
|
|
Opinion of Reed Smith LLP. |
|
|
|
12.1
|
|
Statement regarding Computation of Ratios of Earnings to Fixed Charges and Earnings to Combined Fixed Charges and Preferred Stock
Dividends. |
|
|
|
23.1
|
|
Consent of Independent Registered Public Accounting Firm. |
|
|
|
23.2
|
|
Consent of Reed Smith LLP. |
|
|
|
24.1
|
|
Power of Attorney (included in the signature pages hereto). |
|
|
|
25.1
|
|
Statement of Eligibility and Qualification of Trustee on Form T-1 under Trust Indenture Act of 1939, as amended, for debt
securities indenture.* |
|
|
|
* |
|
To be filed, as applicable, by amendment or as an exhibit to a document to be incorporated by
reference herein in connection with an offering of the securities registered. |