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As filed with the Securities and Exchange Commission on November 28, 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
Halozyme Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
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Delaware
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88-0488686 |
(State or other jurisdiction of
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(I.R.S. Employer |
incorporation or organization)
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Identification Number) |
11388 Sorrento Valley Road
San Diego, California 92121
(858) 794-8889
(Address, including zip code, and telephone number, including area code of registrants principal executive offices)
David A. Ramsay
Halozyme Therapeutics, Inc.
11388 Sorrento Valley Road
San Diego, California 92121
(858) 794-8889
(Name, address, including zip code, and telephone number, including area code, of agent for service)
Copy to:
Douglas J. Rein, Esq.
DLA Piper LLP (US)
4365 Executive Drive, Suite 1100
San Diego, CA 92121-2133
Telephone: (858) 677-1400
Facsimile: (858) 677-1477
From time to time after the effective date of this Registration Statement
(Approximate date of commencement of proposed sale to the public)
If the only securities being registered on this Form are being offered pursuant to dividend or
interest reinvestment plans, please check the following box. o
If any of the securities being registered on this Form are to be offered on a delayed or
continuous basis pursuant to Rule 415 under the Securities Act of 1933, other than securities
offered only in connection with dividend or interest reinvestment plans, check the following
box. þ
If this Form is filed to register additional securities for an offering pursuant to Rule
462(b) under the Securities Act, please check the following box and list the Securities Act
registration statement number of the earlier effective registration statement for the same
offering. o
If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities
Act, check the following box and list the Securities Act registration statement number of the
earlier effective registration statement for the same offering. o
If this Form is a registration statement pursuant to General Instruction I.D. or a
post-effective amendment thereto that shall become effective upon filing with the Commission
pursuant to Rule 462(e) under the Securities Act, check the following box. o
If this Form is a post-effective amendment to a registration statement filed pursuant to
General Instruction I.D. filed to register additional securities or additional classes of
securities pursuant to Rule 413(b) under the Securities Act, check the following
box. o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer, a non-accelerated filer, or a smaller reporting company. See the definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the
Exchange Act. (Check one):
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Large accelerated filer o |
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Accelerated filer þ |
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Non-accelerated filer o
(Do not check if a smaller reporting company) |
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Smaller Reporting Company o |
CALCULATION OF REGISTRATION FEE
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Proposed maximum aggregate |
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Title of each class of securities to be registered (1) |
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offering price (2) |
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Amount of registration fee (3) |
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Common Stock, par value $0.001 per share |
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Preferred Stock, par value $0.001 per share |
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Debt Securities |
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Warrants |
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Units |
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Total |
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$50,000,000 |
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$1,965 (4) |
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(1) |
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There are being registered hereunder such indeterminate number of shares of common stock and
preferred stock, such indeterminate principal amount of debt securities, such indeterminate number
of warrants to purchase common stock, preferred stock or debt securities, and such indeterminate
number of units as shall have an aggregate initial offering price not to exceed $50,000,000. If
any debt securities are issued at an original issued discount, then the offering price of such
debt securities shall be in such greater principal amount as shall result in an aggregate initial
offering price not to exceed $50,000,000, less the aggregate dollar amount of all securities
previously issued hereunder. Any securities registered hereunder may be sold separately or as
units with other securities registered hereunder. The proposed maximum initial offering price per
unit will be determined, from time to time, by the registrant in connection with the issuance by
the registrant of the securities registered hereunder. The securities registered also include such
indeterminate number of shares of common stock and preferred stock and amount of debt securities
as may be issued upon conversion of or exchange for preferred stock or debt securities that
provide for conversion or exchange, upon exercise of warrants or pursuant to the antidilution
provisions of any such securities. In addition, pursuant to Rule 416 under the Securities Act, the
shares being registered hereunder include such indeterminate number of shares of common stock and
preferred stock as may be issuable with respect to the shares being registered hereunder as a
result of stock splits, stock dividends or similar transactions. |
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The proposed maximum aggregate offering price per class of security will be determined from time
to time by the registrant in connection with the issuance by the registrant of the securities
registered hereunder and is not specified as to each class of security pursuant to General
Instruction II.D. of Form S-3 under the Securities Act. |
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(3) |
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Calculated pursuant to Rule 457(o) under the Securities Act. |
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(4) |
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$1,277 was previously paid and $688 is being paid herewith. Halozyme Therapeutics Inc., a Nevada
corporation, to which the registrant is a
successor in accordance with Rule 414(d) promulgated under the Securities Act of 1933, as amended
(the Securities Act), previously paid a registration fee of $5,885 pursuant to previously filed
Registration Statement on Form S-3, File No. 333-125731, as amended (the Prior Registration
Statement), originally filed with the Securities and Exchange Commission on June 10, 2005 and
subsequently declared effective. Of the $50 million of the registrants securities registered
pursuant to the Prior Registration Statement, only $17.5 million of its securities were sold,
resulting in an unused registration fee of $3,825. Pursuant to Rule
415(a)(6) under the
Securities Act, the registrant hereby includes in this registration
statement the $32.5 million of securities remaining unsold under the Prior Registration
Statement. Pursuant to Rule 415(a)(6) the filing fee of $1,277
that is associated with the unsold securities from the Prior
Registration Statement is applied to the securities from the Prior
Registration Statement that are included in this registration
statement. In accordance with Rule 415(a)(6), the Prior
Registration Statement will be deemed terminated as of the effective
date of this registration statement. |
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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 that
specifically states that this registration statement shall thereafter become effective in
accordance with Section 8(a) of the Securities Act of 1933 or until the registration statement
shall become effective on such date as the Securities and Exchange Commission, acting pursuant to
said Section 8(a), may determine.
EXPLANATORY NOTE
Halozyme Therapeutics Inc., a Nevada corporation, to which the registrant is a successor in
accordance with Rule 414(d) promulgated under the Securities Act of 1933, as amended (the
Securities Act), previously filed a Registration Statement on Form S-3 (File No. 333-125731) on
June 10, 2005 (the Prior Registration Statement). The Prior Registration Statement originally
registered up to an aggregate dollar amount of $50,000,000 of securities, but the Prior
Registration Statement will only be effective until December 1, 2008 pursuant to the rules of the
Securities and Exchange Commission. This Registration Statement is intended to renew and replace
the Prior Registration Statement and the Prior Registration Statement will be terminated upon the
effectiveness of this Registration Statement. Pursuant to Rule 457(p) under the Securities Act,
fees paid under the Prior Registration Statement associated with unsold securities offset the total
dollar amount of the filing fee associated with this Registration Statement.
The information in this prospectus is not complete and may be changed. We may not sell these
securities or accept an offer to buy 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 offers to buy these securities in any state where such offer
or sale is not permitted.
SUBJECT TO COMPLETION, DATED NOVEMBER 28, 2008
PROSPECTUS
$50,000,000
Common Stock, Preferred Stock,
Debt Securities,
Warrants and Units
HALOZYME THERAPEUTICS, INC.
From time to time, we may offer up to $50,000,000 of any combination of the securities
described in this prospectus, either individually or in units.
This prospectus provides a general description of the securities we may offer. Each time we
sell securities, we will provide specific terms of the securities offered in a supplement to this
prospectus. We may also authorize one or more free writing prospectuses to be provided to you in
connection with these offerings. The prospectus supplement and any related free writing prospectus
may also add, update or change information contained in this prospectus. You should carefully read
this prospectus, the applicable prospectus supplement and any related free writing prospectus, as
well as any documents incorporated by reference before you invest in any securities. This
prospectus may not be used to consummate a sale of securities unless accompanied by the applicable
prospectus supplement.
Our common stock is listed on The Nasdaq Global Market under the symbol HALO. On November
21, 2008, the last reported sale price for our common stock was $3.29 per share. The applicable
prospectus supplement will contain information, where applicable, as to any other listing on The
Nasdaq Global Market or any securities market or other exchange of the securities, if any, covered
by the prospectus supplement.
INVESTING IN OUR SECURITIES INVOLVES RISKS. YOU SHOULD REVIEW CAREFULLY THE RISKS AND
UNCERTAINTIES DESCRIBED UNDER THE HEADING RISK FACTORS ON PAGE 5 AND CONTAINED IN THE
APPLICABLE PROSPECTUS SUPPLEMENT AND ANY RELATED FREE WRITING PROSPECTUS AND UNDER SIMILAR HEADINGS
IN THE OTHER DOCUMENTS THAT ARE INCORPORATED BY REFERENCE INTO THIS PROSPECTUS.
We will sell these securities directly to investors, through agents designated from time to
time or to or through underwriters or dealers. For additional information on the methods of sale,
you should refer to the section entitled Plan of Distribution in this prospectus. If any
underwriters are involved in the sale of any securities with respect to which this prospectus is
being delivered, the names of such underwriters and any applicable commissions or discounts will be
set forth in a prospectus supplement. The price to the public of such securities and the net
proceeds we expect to receive from such sale will also be set forth in a prospectus supplement.
NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES COMMISSION HAS
APPROVED OR DISAPPROVED OF THESE SECURITIES OR DETERMINED IF THIS PROSPECTUS IS TRUTHFUL OR
COMPLETE. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.
The date of this prospectus is ,
ABOUT THIS PROSPECTUS
This prospectus is a part of a registration statement that we filed with the Securities and
Exchange Commission, or SEC, utilizing a shelf registration process. Under this shelf
registration process, we may sell any combination of the securities described in this prospectus in
one or more offerings up to a total dollar amount of $50,000,000. This prospectus provides you with
a general description of the securities we may offer. Each time we sell securities under this shelf
registration, we will provide a prospectus supplement that will contain specific information about
the terms of that offering. We may also authorize one or more free writing prospectuses to be
provided to you that may contain material information relating to these offerings. The prospectus
supplement and any related free writing prospectus that we may authorize to be provided to you may
also add, update or change information contained in this prospectus or in any documents that we
have incorporated by reference into this prospectus. You should read this prospectus, any
applicable prospectus supplement and any related free writing prospectus, together with the
information incorporated herein by reference as described under the heading Where You Can Find
More Information.
You should rely only on the information that we have provided or incorporated by reference in
this prospectus, any applicable prospectus supplement and any related free writing prospectus that
we may authorize to be provided to you. We have not authorized any dealer, salesman or other person
to give any information or to make any representation other than those contained or incorporated by
reference in this prospectus, any applicable prospectus supplement or any related free writing
prospectus that we may authorize to be provided to you. You must not rely upon any information or
representation not contained or incorporated by reference in this prospectus or the accompanying
prospectus supplement. This prospectus and the accompanying supplement to this prospectus do not
constitute an offer to sell or the solicitation of an offer to buy any securities other than the
registered securities to which they relate, nor do this prospectus and the accompanying supplement
to this prospectus constitute an offer to sell or the solicitation of an offer to buy securities in
any jurisdiction to any person to whom it is unlawful to make such offer or solicitation in such
jurisdiction. You should not assume that the information contained in this prospectus, any
applicable prospectus supplement or any related free writing prospectus is accurate on any date
subsequent to the date set forth on the front of the document or that any information we have
incorporated by reference is correct on any date subsequent to the date of the document
incorporated by reference, even though this prospectus, any applicable prospectus supplement or any
related free writing prospectus is delivered or securities sold on a later date.
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SUMMARY
Prospectus Summary
This summary highlights selected information from this prospectus and does not contain all of
the information that you need to consider in making your investment decision. You should carefully
read the entire prospectus, including the risks of investing discussed under Risk Factors
beginning on page 5, the information incorporated by reference, including our financial statements,
and the exhibits to the registration statement of which this prospectus is a part.
Throughout this prospectus, references to Halozyme, the Company, we, us, and our
refer to Halozyme Therapeutics, Inc.
Our Company
We are a biopharmaceutical company dedicated to the development and commercialization of
products targeting the extracellular matrix for the drug delivery, endocrinology, oncology and
dermatology markets. Our existing products and our products under development are based on
intellectual property covering the family of human enzymes known as hyaluronidases. Hyaluronidases
are enzymes (proteins) that break down hyaluronic acid which is a naturally occurring
space-filling, gel-like substance that is a major component of tissues throughout the body, such as
skin and bone. Our technology is based on our proprietary recombinant human PH20 enzyme, or
rHuPH20, a human synthetic version of hyaluronidase that degrades hyaluronic acid. The PH20 enzyme
is a naturally occurring enzyme that digests hyaluronic acid to temporarily break down the gel,
thereby facilitating the penetration and diffusion of other drugs and fluids that are injected
under the skin or in the muscle.
Our operations to date have been limited to organizing and staffing the Company, acquiring,
developing and securing our technology and undertaking product development for our existing
products and a limited number of product candidates. Over the last year, we have expanded
investments in our proprietary product candidates as we increased our focus on our proprietary
product pipeline. We have two marketed products: Cumulase®, a product used for in vitro
fertilization, or IVF, and HYLENEX, a registered trademark of Baxter International, Inc., a product
used as an adjuvant to increase the absorption and dispersion of other injected drugs and fluids.
Currently, we have only limited revenue from the sales of Cumulase and HYLENEX, in addition to
revenues from collaborative agreements with Baxter Healthcare Corporation, or Baxter, and F.
Hoffmann-La Roche, Ltd and Hoffmann-La Roche, Inc., or collectively Roche. Revenues from product
sales depend on our ability to develop, manufacture, obtain regulatory approvals for and
successfully commercialize our product candidates. We have product candidates in the research,
pre-clinical and clinical stages. It may be years, if ever, before we are able to obtain the
regulatory approvals necessary to generate meaningful revenue from the sale of these product
candidates. We have incurred net operating losses each year since inception, with an accumulated
deficit of approximately $96.8 million as of September 30, 2008.
Sales of a substantial number of shares of our common stock pursuant to a registration
statement or in connection with other transactions could lower the market price of our common stock
and impair our ability to raise capital through the sale of additional equity securities. In the
future, we may issue additional options, warrants or other derivative securities convertible into
our common stock to fund the continued development of our product candidates, the commercialization
of our products or for other general corporate purposes.
Deliatroph Pharmaceuticals, Inc., our predecessor company, was founded on February 26, 1998.
In November 2007, we reincorporated from the State of Nevada to the State of Delaware. Our
principal offices and research facilities are located at 11388 Sorrento Valley Road, San Diego,
California 92121. Our telephone number is (858) 794-8889 and our e-mail address is
info@halozyme.com. Additional information about us can be found on our website at www.halozyme.com,
and in our periodic and current reports filed with the Securities and Exchange Commission (SEC).
Copies of our current and periodic reports filed with the SEC are available at the SEC Public
Reference Room at 450 Fifth Street, N.W., Washington, D.C. 20549, and online at www.sec.gov and our
website at www.halozyme.com. Please note that the information on our website is not incorporated by
reference in this prospectus.
The Securities We May Offer
We may offer shares of our common stock and preferred stock, various series of debt securities
and warrants to purchase any of such securities, either individually or in units, with a total
value of up to $50 million from time to time under this prospectus, together with any applicable
prospectus supplement and related free writing prospectus, at prices and on terms to be determined
by market conditions at the time of offering. This prospectus provides you with a general
description of the securities we may offer. Each time we offer a type or series of securities, we
will provide a prospectus supplement that will describe the specific amounts, prices and other
important terms of the securities, including, to the extent applicable:
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designation or classification; |
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aggregate principal amount or aggregate offering price; |
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maturity, if applicable; |
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original issue discount, if any; |
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rates and times of payment of interest or dividends, if any; |
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redemption, conversion, exchange or sinking fund terms, if any; |
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conversion or exchange prices or rates, if any, and, if applicable,
any provisions for changes to or adjustments in the conversion or
exchange prices or rates and in the securities or other property
receivable upon conversion or exchange; |
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ranking; |
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restrictive covenants, if any; |
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voting or other rights, if any; and |
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important United States federal income tax considerations. |
A prospectus supplement and any related free writing prospectus that we may authorize to be
provided to you may also add, update or change information contained in this prospectus or in
documents we have incorporated by reference. However, no prospectus supplement or free writing
prospectus will offer a security that is not registered and described in this prospectus at the
time of the effectiveness of the registration statement of which this prospectus is a part.
We may sell the securities directly to or through underwriters, dealers or agents. We, and our
underwriters or agents, reserve the right to accept or reject all or part of any proposed purchase
of securities. If we do offer securities through underwriters or agents, we will include in the
applicable prospectus supplement:
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the names of those underwriters or agents; |
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applicable fees, discounts and commissions to be paid to them; |
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details regarding over-allotment options, if any; and |
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the net proceeds to us. |
Common Stock. We may offer shares of our common stock from time to time. Holders of our common
stock are entitled to one vote per share on all other matters that require stockholder approval.
Subject to any preferential rights of any outstanding preferred stock, holders of our common stock
are entitled to dividends when and if declared by the board of directors. Our common stock is
described in greater detail in this prospectus under Description of Capital Stock Common Stock.
Preferred Stock. We currently have authorized 20,000,000 shares of preferred stock, $0.001 par
value per share. We may offer shares of our preferred stock from time to time, in one or more
series. Under our certificate of incorporation, our board of directors currently has the authority
to designate up to 19,500,000 shares of preferred stock in one or more series and to fix the
privileges, preferences and rights of each series of preferred stock, any or all of which may be
greater than the rights of the common stock. Our board of directors has previously designated
500,000 of the 20,000,000 authorized shares of preferred stock as Series A Preferred Stock, none of
which are outstanding. Our Preferred Stock is described in greater detail in this prospectus under
Description of Capital Stock Preferred Stock.
We will fix the rights, preferences, privileges, qualifications and restrictions of the
preferred stock of each series that we sell under this prospectus and applicable prospectus
supplements in the certificate of designation relating to that series. We will incorporate by
reference into the registration statement of which this prospectus is a part the form of any
certificate of designation that
describes the terms of the series of preferred stock we are offering before the issuance of
the related series of preferred stock. We urge you to read the prospectus supplements and any free
writing prospectus that we may authorize to be provided to you related to the series of preferred
stock being offered, as well as the complete certificate of designation that contains the terms of
the applicable series of preferred stock.
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Debt Securities. We may offer debt securities from time to time, in one or more series, as
either senior or subordinated debt or as senior or subordinated convertible debt. The senior debt
securities will rank equally with any other unsubordinated debt that we may have and may be secured
or unsecured. The subordinated debt securities will be subordinate and junior in right of payment,
to the extent and in the manner described in the instrument governing the debt, to all or some
portion of our indebtedness. Any convertible debt securities that we issue will be convertible into
or exchangeable for our common stock or other securities of ours. Conversion may be mandatory or at
the holders option and would be at prescribed conversion rates.
The debt securities will be issued under one or more documents called indentures, which are
contracts between us and a trustee for the holders of the debt securities. In this prospectus, we
have summarized certain general features of the debt securities under Description of Debt
Securities. We urge you, however, to read the prospectus supplements and any free writing
prospectus that we may authorize to be provided to you related to the series of debt securities
being offered, as well as the complete indentures that contain the terms of the debt securities.
Forms of indentures have been filed as exhibits to the registration statement of which this
prospectus is a part, and supplemental indentures and forms of debt securities containing the terms
of debt securities being offered will be incorporated by reference into the registration statement
of which this prospectus is a part from reports we file with the SEC.
Warrants. We may offer warrants for the purchase of our common stock, preferred stock and/or
debt securities in one or more series, from time to time. We may issue warrants independently or
together with common stock, preferred stock and/or debt securities, and the warrants may be
attached to or separate from those securities.
The warrants will be evidenced by warrant certificates issued under one or more warrant
agreements, which are contracts between us and an agent for the holders of the warrants. In this
prospectus, we have summarized certain general features of the warrants under Description of
Warrants. We urge you, however, to read the prospectus supplements and any free writing prospectus
that we may authorize to be provided to you related to the series of warrants being offered, as
well as the complete warrant agreements and warrant certificates that contain the terms of the
warrants. Specific warrant agreements will contain additional important terms and provisions and
will be incorporated by reference as an exhibit to the registration statement which includes this
prospectus.
Units. We may offer units consisting of common stock, preferred stock, debt securities and/or
warrants to purchase any of such securities in one or more series. In this prospectus, we have
summarized certain general features of the units under Description of Units. We urge you,
however, to read the prospectus supplements and any free writing prospectus that we may authorize
to be provided to you related to the series of units being offered, as well as the unit agreements
that contain the terms of the units. We will file as exhibits to the registration statement of
which this prospectus is a part, or will incorporate by reference from a current report on Form 8-K
that we file with the SEC, the form of unit agreement and any supplemental agreements that describe
the terms of the series of units we are offering before the issuance of the related series of
units.
We will evidence each series of units by unit certificates that we will issue under a separate
agreement. We will enter into the unit agreements with a unit agent. Each unit agent will be a bank
or trust company that we select. We will indicate the name and address of the unit agent in the
applicable prospectus supplement relating to a particular series of units.
THIS PROSPECTUS MAY NOT BE USED TO OFFER OR SELL ANY SECURITIES UNLESS ACCOMPANIED BY A
PROSPECTUS SUPPLEMENT.
4
RISK FACTORS
Investing in our securities involves a high degree of risk. You should carefully consider the
risk factors incorporated by reference to our most recent Annual Report on Form 10-K and our
Quarterly Reports on Form 10-Q filed with the SEC in addition to the other information contained in
this prospectus, as updated by our subsequent filings under the Securities Exchange Act of 1934, as
amended, or the Exchange Act, and the risk factors and other information contained in any
applicable prospectus supplement and in any related free writing prospectuses in connection with a
specific offering, and in the documents incorporated herein or therein before deciding whether to
purchase any of the securities being registered pursuant to the registration statement of which
this prospectus is a part. Each of the risk factors could adversely affect our business, operating
results and financial condition, as well as adversely affect the value of an investment in our
securities, and the occurrence of any of these risks might cause you to lose all or part of your
investment.
Risks Related To Our Business
We have generated only minimal revenue from product sales to date; we have a history of net losses
and negative cash flow, and we may never achieve or maintain profitability.
We have generated only minimal revenue from product sales to date and may never generate
significant revenues from future product sales. Even if we do achieve significant revenues from
product sales, licensing revenues and/or milestone payments, we expect to incur significant
operating losses over the next several years. We have never been profitable, and we may never
become profitable. Through September 30, 2008, we have incurred aggregate net losses of
approximately $96.8 million.
If any party to a key collaboration agreement, including us, fails to perform material obligations
under such agreement, or if a key collaboration agreement is terminated for any reason, our
business would significantly suffer.
We have entered into key collaboration agreements under which we may receive significant
future payments in the form of maintenance fees, milestone payments and royalties. In the event
that a party fails to perform under a key collaboration agreement, or if a key collaboration
agreement is terminated, the reduction in anticipated revenues could delay or suspend our product
development activities for some of our product candidates as well as our commercialization efforts
for some or all of our products. In addition, the termination of a key collaboration agreement by
one of our partners could materially impact our ability to enter into additional collaboration
agreements with new partners on favorable terms, if at all. In certain circumstances, the
termination of a key collaboration agreement would require us to revise our corporate strategy
going forward and reevaluate the applications and value of our technology.
If our contract manufacturers are unable to manufacture significant amounts of the active
pharmaceutical ingredient used in our products and product candidates, our product development and
commercialization efforts could be delayed or stopped.
We have existing supply agreements with contract manufacturing organizations Avid Bioservices,
Inc., or Avid, and Cook Pharmica LLC, or Cook, to produce bulk recombinant human hyaluronidase for
clinical trials and commercial use. These manufacturers will produce the active pharmaceutical
ingredient used in our products and product candidates under cGMP for both clinical and commercial
scale production and will provide support for the chemistry, manufacturing and controls sections
for FDA regulatory filings. These manufacturers have limited experience manufacturing our active
pharmaceutical ingredient batches, and we rely on their ability to successfully manufacture these
batches according to product specifications. In addition, as a result of our contractual
obligations to Roche, we will be required to significantly scale up our active pharmaceutical
ingredient production at Cook during the next few years. We do not currently have a significant
inventory of the active pharmaceutical ingredient used in our products and product candidates, so
if these manufacturers do not maintain their status as FDA-approved manufacturing facilities, are
unable to successfully scale up our active pharmaceutical ingredient production, or are unable to
manufacture the active pharmaceutical ingredient used in our products and product candidates
according to product specifications for any other reason, the commercialization of our products and
the development of our product candidates will be delayed and our business will be adversely
affected. We have not yet established, and may not be able to establish, favorable arrangements
with additional manufacturers for these ingredients or products should the existing supplies become
unavailable or in the event that our existing contract manufacturers are unable to adequately
perform their responsibilities. Any delays or interruptions in the supply of materials by Avid
and/or Cook could cause the delay of clinical trials and could delay or prevent the
commercialization of product candidates that may receive regulatory approval. Such delays or
interruptions would have a material adverse effect on our business and financial condition.
5
If we are unable to sufficiently develop our sales, marketing and distribution capabilities or
enter into successful agreements with third parties to perform these functions, we will not be able
to fully commercialize our products.
We may not be successful in marketing and promoting our existing product candidates or any
other products we develop or acquire in the future. We are currently in the process of developing
our sales, marketing and distribution capabilities. However, our
current capabilities in these areas are very limited. In order to commercialize any products
successfully, we must internally develop substantial sales, marketing and distribution capabilities
or establish collaborations or other arrangements with third parties to perform these services. We
do not have extensive experience in these areas, and we may not be able to establish adequate
in-house sales, marketing and distribution capabilities or engage and effectively manage
relationships with third parties to perform any or all of such services. To the extent that we
enter into co-promotion or other licensing arrangements, our product revenues are likely to be
lower than if we directly marketed and sold our products, and any revenues we receive will depend
upon the efforts of third parties, whose efforts may not meet our expectations or be successful.
We have entered into an exclusive sales and marketing agreement with Baxter to market and sell
our HYLENEX product in the United States and Puerto Rico. Baxter also has the right to market and
sell HYLENEX on an exclusive basis in all territories outside of the United States, if and when we
seek and receive the applicable regulatory approvals in those territories.
We depend upon the efforts of third parties, such as Baxter, to promote and sell our current
products, but there can be no assurance that the efforts of these third parties will meet our
expectations or result in any significant product sales. While these third parties are largely
responsible for the speed and scope of sales and marketing efforts, they may not dedicate the
resources necessary to maximize product opportunities and our ability to cause these third parties
to increase the speed and scope of their efforts may be limited. In addition, sales and marketing
efforts could be negatively impacted by the delay or failure to obtain additional supportive
clinical trial data for our products. In some cases, third party partners are responsible for
conducting these additional clinical trials and our ability to increase the efforts and resources
allocated to these trials may be limited.
If we have problems with third parties that prepare, fill, finish, and package our products and
product candidates for distribution, our product commercialization and development efforts for
these products and product candidates could be delayed or stopped.
We rely on third parties to prepare, fill, finish, and package our products and product
candidates prior to their distribution. If we are unable to locate third parties to perform these
functions on terms that are economically acceptable to us, the progress of clinical trials could be
delayed or even suspended and the commercialization of approved product candidates could be delayed
or prevented. We currently utilize a third-party to prepare, fill, finish, and package Cumulase and
this third party has not historically demonstrated a consistent ability to manufacture Cumulase
according to product specifications. We previously entered into an agreement with another third
party to prepare, fill, finish and package Cumulase, but that third party did not meet the
manufacturing, technical and cost targets that were originally established. In addition, we
currently utilize a subsidiary of Baxter to prepare, fill, finish, and package HYLENEX under a
development and supply agreement. Baxter has only limited experience manufacturing HYLENEX batches,
and we rely on its ability to successfully manufacture HYLENEX batches according to product
specifications. Any delays or interruptions in Baxters ability to manufacture HYLENEX batches in
amounts necessary to meet product demand could have a material adverse impact on our business and
financial condition.
If we do not receive and maintain regulatory approvals for our product candidates, we will not be
able to commercialize our products, which would substantially impair our ability to generate
revenues.
With the exception of the December 2004 receipt of a CE (European Conformity) Mark for
Cumulase, the April 2005 FDA clearance for Cumulase and the December 2005 FDA approval for our
spreading agent, HYLENEX, none of our product candidates has received regulatory approval from the
FDA or from any similar national regulatory agency or authority in any other country in which we
intend to do business. Approval from the FDA is necessary to manufacture and market pharmaceutical
products in the United States. Most other countries in which we may do business have similar
requirements.
Other manufacturers have FDA approved products for use as spreading agents, including ISTA
Pharmaceuticals, Inc., or ISTA, with an ovine-derived hyaluronidase, Vitrase®, Amphastar
Pharmaceuticals, Inc., or Amphastar, with a bovine-derived hyaluronidase, Amphadase,
and Primapharm, Inc., or Primapharm, also with a bovine-derived hyaluronidase, Hydase.
The FDA has determined that Amphadase, Hydase, HYLENEX and Vitrase are each distinct new chemical
entities and hence afforded five years of market exclusivity. The five year market exclusivity
precludes identical new chemical entity products from being marketed for a period of five years.
For so long as each of these products is established as a distinctly different new chemical entity,
the marketing exclusivity granted does not prohibit the marketing of any of these products,
including HYLENEX. If the FDA changes its earlier determination that HYLENEX is a distinct new
chemical entity, our ability to market HYLENEX will be materially impaired.
The process for obtaining FDA approval is extensive, time-consuming and costly, and there is
no guarantee that the FDA will approve any NDAs that we intend to file with respect to any of our
product candidates, or that the timing of any such approval will be appropriate for our product
launch schedule and other business priorities, which are subject to change. We have not currently
begun the NDA approval process for any of our other potential products, and we may not be
successful in obtaining such approvals for any of our potential products.
6
We may not receive regulatory approvals for our product candidates for a variety of reasons,
including unsuccessful clinical trials.
Clinical testing of pharmaceutical products is a long, expensive and uncertain process and the
failure of a clinical trial can occur at any stage. Even if initial results of pre-clinical studies
or clinical trial results are promising, we may obtain different results that fail to show the
desired levels of safety and efficacy, or we may not obtain FDA approval for a variety of other
reasons. The clinical trials of any of our product candidates could be unsuccessful, which would
prevent us from obtaining regulatory approval and commercializing the product. FDA approval can be
delayed, limited or not granted for many reasons, including, among others:
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FDA officials may not find a product candidate safe or effective
enough to merit either continued testing or final approval; |
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FDA officials may not find that the data from pre-clinical testing and
clinical trials justifies approval, or they may require additional
studies that would make it commercially unattractive to continue
pursuit of approval; |
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the FDA may reject our trial data or disagree with our interpretations
of either clinical trial data or applicable regulations; |
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the cost of a clinical trial may be greater than what we originally
anticipate, and we may decide to not pursue FDA approval for such a
trial; |
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the FDA may not approve our manufacturing processes or facilities, or
the processes or facilities of our contract manufacturers or raw
material suppliers; |
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the FDA may change its formal or informal approval requirements and
policies, act contrary to previous guidance, or adopt new regulations;
or |
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the FDA may approve a product candidate for indications that are
narrow or under conditions that place the product at a competitive
disadvantage, which may limit our sales and marketing activities or
otherwise adversely impact the commercial potential of a product. |
If the FDA does not approve our product candidates in a timely fashion on commercially viable
terms, or if we terminate development of any of our product candidates due to difficulties or
delays encountered in the regulatory approval process, it will have a material adverse impact on
our business and we will be dependent on the development of our other product candidates and/or our
ability to successfully acquire other products and technologies. We may not receive regulatory
approval of our Chemophase product candidate or any other product candidates, in a timely manner,
or at all.
We intend to market certain of our products, and perhaps have certain of our products
manufactured, in foreign countries. The process of obtaining regulatory approvals in foreign
countries is subject to delay and failure for many of the same reasons set forth above as well as
for reasons that vary from jurisdiction to jurisdiction. The approval process varies among
countries and jurisdictions and can involve additional testing. The time required to obtain
approval may differ from that required to obtain FDA approval. We may not obtain foreign regulatory
approvals on a timely basis, if at all. Approval by the FDA does not ensure approval by regulatory
authorities in other countries or jurisdictions, and approval by one foreign regulatory authority
does not ensure approval by regulatory authorities in other foreign countries or jurisdictions or
by the FDA.
If we fail to comply with regulatory requirements, regulatory agencies may take action against us,
which could significantly harm our business.
Any approved products, along with the manufacturing processes, post-approval clinical data,
labeling, advertising and promotional activities for these products, are subject to continual
requirements and review by the FDA and other regulatory bodies. Regulatory authorities subject a
marketed product, its manufacturer and the manufacturing facilities to continual review and
periodic inspections. We will be subject to ongoing FDA requirements, including required
submissions of safety and other post-market information and reports, registration requirements,
current Good Manufacturing Processes, or cGMP, regulations, requirements regarding the distribution
of samples to physicians and recordkeeping requirements. The cGMP regulations include requirements
relating to quality control and quality assurance, as well as the corresponding maintenance of
records and documentation. We rely on the compliance by our contract manufacturers with cGMP
regulations and other regulatory requirements relating to the manufacture of our products. We are
also subject to state laws and registration requirements covering the distribution of our products.
Regulatory agencies may change existing requirements or adopt new requirements or policies. We may
be slow to adapt or may not be able to adapt to these changes or new requirements.
7
Later discovery of previously unknown problems with our products, manufacturing processes or
failure to comply with regulatory requirements, may result in any of the following:
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restrictions on our products or manufacturing processes; |
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warning letters; |
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withdrawal of the products from the market; |
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voluntary or mandatory recall; |
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fines; |
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suspension or withdrawal of regulatory approvals; |
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suspension or termination of any of our ongoing clinical trials; |
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refusal to permit the import or export of our products; |
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refusal to approve pending applications or supplements to approved applications that we submit; |
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product seizure; or |
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injunctions or the imposition of civil or criminal penalties. |
We may wish to raise funds in the next twelve months, and there can be no assurance that such funds
will be available.
During the next twelve months, we may wish to raise additional capital to continue the
development of our product candidates and to fund general operations. Our current cash position and
expected revenues during the next several years will not constitute the amount of capital necessary
for us to continue the development of our product candidates and to fund general operations. In
addition, if we engage in acquisitions of companies, products, or technology in order to execute
our business strategy, we may need to raise additional capital. We expect to raise additional
capital in the future through one or more financing vehicles that may be available to us. These
financing vehicles currently include: (i) the public offering of securities; (ii) new collaborative
agreements; (iii) expansions or revisions to existing collaborative relationships; (iv) private
financings and/or (v) other equity or debt financings.
Currently, warrants to purchase approximately 3.3 million shares of our common stock are
outstanding and this amount of outstanding warrants may make us a less desirable candidate for
investment for some potential investors. Considering our stage of development and the nature of our
capital structure, if we are required to raise additional capital in the future, the additional
financing may not be available on favorable terms, or at all. If we are successful in raising
additional capital, a substantial number of additional shares may be issued and these shares will
dilute the ownership interest of our current investors.
If our product candidates are approved by the FDA but do not gain market acceptance, our business
will suffer because we may not be able to fund future operations.
Assuming that we obtain the necessary regulatory approvals, a number of factors may affect the
market acceptance of any of our existing product candidates or any other products we develop or
acquire in the future, including, among others:
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the price of our products relative to other therapies for the same or similar treatments; |
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the perception by patients, physicians and other members of the health care community of the
effectiveness and safety of our products for their prescribed treatments; |
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our ability to fund our sales and marketing efforts; |
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the degree to which the use of our products is restricted by the product label approved by the FDA; |
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the effectiveness of our sales and marketing efforts; and |
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the introduction of generic competitors. |
8
If our products do not gain market acceptance, we may not be able to fund future operations,
including the development or acquisition of new product candidates and/or our sales and marketing
efforts for our approved products, which would cause our business to suffer.
In addition, our ability to market and promote our product candidates will be restricted to
the labels approved by the FDA. If the approved labels are restrictive, our sales and marketing
efforts may be negatively affected.
Developing and marketing pharmaceutical products for human use involves product liability risks,
for which we currently have limited insurance coverage.
The testing, marketing and sale of pharmaceutical products involves the risk of product
liability claims by consumers and other third parties. Although we maintain product liability
insurance coverage, product liability claims can be high in the pharmaceutical industry and our
insurance may not sufficiently cover our actual liabilities. If product liability claims were made
against us, it is possible that our insurance carriers may deny, or attempt to deny, coverage in
certain instances. If a lawsuit against us is successful, then the lack or insufficiency of
insurance coverage could materially and adversely affect our business and financial condition.
Furthermore, various distributors of pharmaceutical products require minimum product liability
insurance coverage before purchase or acceptance of products for distribution. Failure to satisfy
these insurance requirements could impede our ability to achieve broad distribution of our proposed
products and the imposition of higher insurance requirements could impose additional costs on us.
Our inability to attract, hire and retain key management and scientific personnel, and to recruit
qualified independent directors, could negatively affect our business.
Our success depends on the performance of key management and scientific employees with
biotechnology experience. Given our small staff size and programs currently under development, we
depend substantially on our ability to hire, train, retain and motivate high quality personnel,
especially our scientists and management team in this field. If we are unable to retain existing
personnel or identify or hire additional personnel, we may not be able to research, develop,
commercialize or market our product candidates as expected or on a timely basis and, as a result,
our business may be harmed. In addition, we rely on the expertise and guidance of independent
directors to develop business strategies and to guide our execution of these strategies. Due to
changes in the regulatory environment for public companies over the past few years, the demand for
independent directors has increased and it may be difficult for us, due to competition from both
like-size and larger companies, to recruit qualified independent directors.
Furthermore, if we were to lose key management personnel, particularly Jonathan Lim, M.D., our
president and chief executive officer, or Gregory Frost, Ph.D., our vice president and chief
scientific officer, then we would likely lose some portion of our institutional knowledge and
technical know-how, potentially causing a substantial delay in one or more of our development
programs until adequate replacement personnel could be hired and trained. For example, Dr. Frost
has been with us from soon after our inception, and he possesses a substantial amount of knowledge
about our development efforts. If we were to lose his services, we would experience delays in
meeting our product development schedules. We have not entered into any retention or other
agreements specifically designed to motivate officers or other employees to remain with us, other
than standard agreements relating to the vesting of stock options that every optionee of the
Company must enter into as a condition of receiving an option grant.
We do not have key man life insurance policies on the lives of any of our employees, including
Dr. Lim and Dr. Frost.
Risks Related To Ownership of Our Common Stock
Future sales of shares of our common stock upon the exercise of currently outstanding securities or
pursuant to our universal shelf registration statement may negatively affect our stock price.
As a result of our January 2004 private financing transaction, we issued warrants to private
investors for the purchase of approximately 10.5 million shares of common stock at purchase prices
ranging from $0.77 to $1.75 per share. Currently, approximately 1.4 million shares of common stock
remain issuable upon the exercise of these warrants. As a result of our October 2004 financing
transaction, we issued warrants for the purchase of approximately 2.7 million shares of common
stock at a purchase price of $2.25 per share. Currently, approximately 1.9 million shares of common
stock remain issuable upon the exercise of these warrants. The exercise of these warrants could
result in dilution to stockholders at the time of exercise which could negatively affect our stock
price.
We currently have the ability, at any time prior to December 1, 2008, to offer and sell up to
$32.5 million of additional equity or debt securities under a currently effective universal shelf
registration statement. Sales of substantial amounts of shares of our common stock or other
securities under this or any future shelf registration statement could lower the market price of
our common stock and impair our ability to raise capital through the sale of equity securities. In
the future, we may issue additional options,
warrants or other derivative securities convertible into our common stock.
9
Our stock price is subject to significant volatility.
We participate in a highly dynamic industry which often results in significant volatility in
the market price of common stock irrespective of company performance. As a result, our high and low
sales prices of our common stock during the twelve months ended September 30, 2008 were $9.46 and
$4.19, respectively. We expect our stock price to continue to be subject to significant volatility
and, in addition to the other risks and uncertainties described elsewhere in this prospectus and
all other risks and uncertainties that are either not known to us at this time or which we deem to
be immaterial, any of the following factors may lead to a significant drop in our stock price:
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our failure, or the failure of one of our third party partners, to comply with the
terms of our collaboration agreements; |
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the termination, for any reason, of any of our collaboration agreements; |
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the sale of common stock by any significant stockholder, including, but not limited
to, direct or indirect sales by members of management or our Board of Directors; |
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general negative conditions in the healthcare industry; |
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general negative conditions in the financial markets; |
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the failure, for any reason, to obtain FDA approval for any of our product candidates; |
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the failure, for any reason, to secure or defend our intellectual property position; |
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for those products that are approved by the FDA, the failure of the FDA to approve
such products in a timely manner consistent with the FDAs historical approval
process; |
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the suspension of any clinical trial due to safety or patient tolerability issues; |
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the suspension of any clinical trial due to market and/or competitive conditions; |
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our failure, or the failure of our third party partners, to successfully
commercialize products approved by the FDA; |
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our failure, or the failure of our third party partners, to generate product revenues
anticipated by investors; |
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problems with an API contract manufacturer or a fill and finish manufacturer for any
product or product candidate; |
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the sale of additional debt and/or equity securities by us; and |
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the departure of key personnel. |
Trading in our stock has historically been limited, so investors may not be able to sell as much
stock as they want to at prevailing market prices.
Our stock has historically traded at a low daily trading volume. If recent trading volumes
decrease, it may be difficult for stockholders to sell their shares in the public market at any
given time at prevailing prices.
The exercise of outstanding warrants may drive down the market price of our stock.
Outstanding warrants that may be exercised for approximately 1.4 million shares of common
stock will expire per their terms in January 2009. In addition, warrants that may be exercised for
approximately 1.9 million shares of common stock will expire per their terms in October 2009. Some
warrant holders may choose to sell outstanding shares of common stock in order to finance the
exercise of their warrants and this pattern of selling may result in a reduction of our common
stocks market price.
10
Risks Related To Our Industry
Compliance with the extensive government regulations to which we are subject is expensive and time
consuming and may result in the delay or cancellation of product sales, introductions or
modifications.
Extensive industry regulation has had, and will continue to have, a significant impact on our
business. All pharmaceutical companies, including ours, are subject to extensive, complex, costly
and evolving regulation by the federal government, principally the FDA and, to a lesser extent, the
U.S. Drug Enforcement Administration, or DEA, and foreign and state government agencies. The
Federal Food, Drug and Cosmetic Act, the Controlled Substances Act and other domestic and foreign
statutes and regulations govern or influence the testing, manufacturing, packaging, labeling,
storing, recordkeeping, safety, approval, advertising, promotion, sale and distribution of our
products. Under certain of these regulations, we and our contract suppliers and manufacturers are
subject to periodic inspection of our or their respective facilities, procedures and operations
and/or the testing of products by the FDA, the DEA and other authorities, which conduct periodic
inspections to confirm that we and our contract suppliers and manufacturers are in compliance with
all applicable regulations. The FDA also conducts pre-approval and post-approval reviews and plant
inspections to determine whether our systems, or our contract suppliers and manufacturers
processes, are in compliance with cGMP and other FDA regulations. If we, or our contract supplier,
fail these inspections, we may not be able to commercialize our product in a timely manner without
incurring significant additional costs, or at all.
In addition, the FDA imposes a number of complex regulatory requirements on entities that
advertise and promote pharmaceuticals including, but not limited to, standards and regulations for
direct-to-consumer advertising, off-label promotion, industry-sponsored scientific and educational
activities, and promotional activities involving the internet.
We are dependent on receiving FDA and other governmental approvals prior to manufacturing,
marketing and shipping our products. Consequently, there is always a risk that the FDA or other
applicable governmental authorities will not approve our products, or will take post-approval
action limiting or revoking our ability to sell our products, or that the rate, timing and cost of
such approvals will adversely affect our product introduction plans or results of operations.
Our suppliers and manufacturers are subject to regulation by the FDA and other agencies, and if
they do not meet their commitments, we would have to find substitute suppliers or manufacturers,
which could delay the supply of our products to market.
Regulatory requirements applicable to pharmaceutical products make the substitution of
suppliers and manufacturers costly and time consuming. We have no internal manufacturing
capabilities and are, and expect to be in the future, entirely dependent on contract manufacturers
and suppliers for the manufacture of our products and for their active and other ingredients. The
disqualification of these manufacturers and suppliers through their failure to comply with
regulatory requirements could negatively impact our business because the delays and costs in
obtaining and qualifying alternate suppliers (if such alternative suppliers are available, which we
cannot assure) could delay clinical trials or otherwise inhibit our ability to bring approved
products to market, which would have a material adverse effect on our business and financial
condition.
We may be required to initiate or defend against legal proceedings related to intellectual property
rights, which may result in substantial expense, delay and/or cessation of the development and
commercialization of our products.
We rely on patents to protect our intellectual property rights. The strength of this
protection, however, is uncertain. For example, it is not certain that:
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our patents and pending patent applications cover products and/or technology that we invented first; |
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we were the first to file patent applications for these inventions; |
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others will not independently develop similar or alternative technologies or duplicate our technologies; |
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any of our pending patent applications will result in issued patents; and |
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any of our issued patents, or patent pending applications that result in issued patents, will be held
valid and infringed in the event the patents are asserted against others. |
We currently own or license several U.S. patents and also have pending patent applications.
There can be no assurance that our existing patents, or any patents issued to us as a result of our
pending patent applications, will provide a basis for commercially viable products, will provide us
with any competitive advantages, or will not face third party challenges or be the subject of
further proceedings limiting their scope or enforceability. Such limitations in our patent
portfolio could have a material adverse effect on our business and financial condition. In
addition, if any of our pending patent applications do not result in issued patents, this could
have a
material adverse effect on our business and financial condition.
11
We may become involved in interference proceedings in the U.S. Patent and Trademark Office to
determine the priority of our inventions. In addition, costly litigation could be necessary to
protect our patent position. We also rely on trademarks to protect the names of our products. These
trademarks may be challenged by others. If we enforce our trademarks against third parties, such
enforcement proceedings may be expensive. We also rely on trade secrets, unpatented proprietary
know-how and continuing technological innovation that we seek to protect with confidentiality
agreements with employees, consultants and others with whom we discuss our business. Disputes may
arise concerning the ownership of intellectual property or the applicability or enforceability of
these agreements, and we might not be able to resolve these disputes in our favor.
In addition to protecting our own intellectual property rights, third parties may assert
patent, trademark or copyright infringement or other intellectual property claims against us based
on what they believe are their own intellectual property rights. If we become involved in any
intellectual property litigation, we may be required to pay substantial damages, including but not
limited to treble damages, for past infringement if it is ultimately determined that our products
infringe a third partys intellectual property rights. Even if infringement claims against us are
without merit, defending a lawsuit takes significant time, may be expensive and may divert
managements attention from other business concerns. Further, we may be stopped from developing,
manufacturing or selling our products until we obtain a license from the owner of the relevant
technology or other intellectual property rights. If such a license is available at all, it may
require us to pay substantial royalties or other fees.
Future acquisitions could disrupt our business and harm our financial condition.
In order to augment our product pipeline or otherwise strengthen our business, we may decide
to acquire additional businesses, products and technologies. As we have limited experience in
evaluating and completing acquisitions, our ability as an organization to make such acquisitions is
unproven. Acquisitions could require significant capital infusions and could involve many risks,
including, but not limited to, the following:
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we may have to issue convertible debt or equity securities to complete
an acquisition, which would dilute our stockholders and could
adversely affect the market price of our common stock; |
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an acquisition may negatively impact our results of operations because
it may require us to incur large one-time charges to earnings,
amortize or write down amounts related to goodwill and other
intangible assets, or incur or assume substantial debt or liabilities,
or it may cause adverse tax consequences, substantial depreciation or
deferred compensation charges; |
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we may encounter difficulties in assimilating and integrating the
business, products, technologies, personnel or operations of companies
that we acquire; |
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certain acquisitions may disrupt our relationship with existing
customers who are competitive with the acquired business, products or
technologies; |
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acquisitions may require significant capital infusions and the
acquired businesses, products or technologies may not generate
sufficient revenue to offset acquisition costs; |
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an acquisition may disrupt our ongoing business, divert resources,
increase our expenses and distract our management; |
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acquisitions may involve the entry into a geographic or business
market in which we have little or no prior experience; and |
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key personnel of an acquired company may decide not to work for us. |
If any of these risks occurred, it could adversely affect our business, financial condition
and operating results. We cannot assure you that we will be able to identify or consummate any
future acquisitions on acceptable terms, or at all. If we do pursue any acquisitions, it is
possible that we may not realize the anticipated benefits from such acquisitions or that the market
will not view such acquisitions positively.
If third party reimbursement and customer contracts are not available, our products may not be
accepted in the market.
Our ability to earn sufficient returns on our products will depend in part on the extent to
which reimbursement for our products and related treatments will be available from government
health administration authorities, private health insurers, managed
care organizations and other healthcare providers.
12
Third-party payors are increasingly attempting to limit both the coverage and the level of
reimbursement of new drug products to contain costs. Consequently, significant uncertainty exists
as to the reimbursement status of newly approved healthcare products. Third party payors may not
establish adequate levels of reimbursement for the products that we commercialize, which could
limit their market acceptance and result in a material adverse effect on our financial condition.
Customer contracts, such as with group paying organizations and hospital formularies, will
often not offer contract or formulary status without either the lowest price or substantial proven
clinical differentiation. If our products are compared to animal-derived hyaluronidases by these
entities, it is possible that neither of these conditions will be met, which could limit market
acceptance and result in a material adverse effect on our financial condition.
The rising cost of healthcare and related pharmaceutical product pricing has led to cost
containment pressures that could cause us to sell our products at lower prices, resulting in less
revenue to us.
Any of our products that have been or in the future are approved by the FDA may be purchased
or reimbursed by state and federal government authorities, private health insurers and other
organizations, such as health maintenance organizations and managed care organizations. Such third
party payors increasingly challenge pharmaceutical product pricing. The trend toward managed
healthcare in the United States, the growth of such organizations, and various legislative
proposals and enactments to reform healthcare and government insurance programs, including the
Medicare Prescription Drug Modernization Act of 2003, could significantly influence the manner in
which pharmaceutical products are prescribed and purchased, resulting in lower prices and/or a
reduction in demand. Such cost containment measures and healthcare reforms could adversely affect
our ability to sell our products. Furthermore, individual states have become increasingly
aggressive in passing legislation and implementing regulations designed to control pharmaceutical
product pricing, including price or patient reimbursement constraints, discounts, restrictions on
certain product access, importation from other countries and bulk purchasing. Legally mandated
price controls on payment amounts by third party payors or other restrictions could negatively and
materially impact our revenues and financial condition. We anticipate that we will encounter
similar regulatory and legislative issues in most other countries outside the United States.
We face intense competition and rapid technological change that could result in the development of
products by others that are superior to the products we are developing.
We have numerous competitors in the United States and abroad including, among others, major
pharmaceutical and specialized biotechnology firms, universities and other research institutions
that may be developing competing products. Such competitors include, but are not limited to,
Sigma-Aldrich Corporation, ISTA, Amphastar and Primapharm among others. These competitors may
develop technologies and products that are more effective, safer, or less costly than our current
or future product candidates or that could render our technologies and product candidates obsolete
or noncompetitive. Many of these competitors have substantially more resources and product
development, manufacturing and marketing experience and capabilities than we do. In addition, many
of our competitors have significantly greater experience than we do in undertaking pre-clinical
testing and clinical trials of pharmaceutical product candidates and obtaining FDA and other
regulatory approvals of products and therapies for use in healthcare. Other manufacturers have FDA
approved products for use as spreading agents, including ISTA, with an ovine-derived hyaluronidase,
Vitrase, Amphastar, with a bovine-derived hyaluronidase, Amphadase, and Primapharm, also with a
bovine-derived hyaluronidase, Hydase. The FDA has determined that Amphadase, Hydase, HYLENEX and
Vitrase are distinct new chemical entities and hence afforded five years of market exclusivity.
The five year market exclusivity precludes identical new chemical entity products from being
marketed for a period of five years. As each of these products is established as distinctly
different new chemical entities, the marketing exclusivity granted does not prohibit the marketing
of the products.
13
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus and the documents incorporated by reference contain forward-looking
statements. These are based on our managements current beliefs, expectations and assumptions about
future events, conditions and results and on information currently available to us. Discussions
containing these forward-looking statements may be found, among other places, in the Sections
entitled Business, Risk Factors and Managements Discussion and Analysis of Financial
Condition and Results of Operations incorporated by reference from our most recent Annual Report
on Form 10-K and in our Quarterly Reports on Form 10-Q, as well as any amendments thereto, filed
with the SEC. Within the meaning of Section 27A of the Securities Act of 1933, as amended, or the
Securities Act, and Section 21E of the Exchange Act, these forward-looking statements include, but
are not limited to, statements about our business, technologies, prospects, partners, customers,
suppliers and regulatory strategies.
All statements, other than statements of historical fact, included or incorporated herein
regarding our strategy, future operations, financial position, future revenues, projected costs,
plans, prospectus and objectives are forward-looking statements. In some cases, you can identify
forward-looking statements by terms such as anticipate, believe, could, estimate, expect,
intend, may, plan, potential, predict, project, should, will, would and similar
expressions. These statements involve risks, uncertainties and other factors that may cause our
actual results, performance, time frames or achievements to be materially different from any future
results, performance, time frames or achievements expressed or implied by the forward-looking
statements. Risks, uncertainties and other factors that might cause or contribute to such
differences include, but are not limited to, those discussed in the Section entitled Risk Factors
in our most recent Annual Report on Form 10-K and in our Quarterly Reports on Form 10-Q, as well as
any amendments thereto filed with the SEC. Given these risks, uncertainties and other factors, many
of which are beyond our control, you should not place undue reliance on these forward-looking
statements.
Except as required by law, we assume no obligation to update these forward-looking statements
publicly, or to revise any forward-looking statements to reflect events or developments occurring
after the date of this prospectus, even if new information becomes available in the future.
14
FINANCIAL RATIOS
The following table sets forth our ratio of earnings to fixed charges and the ratio of our
earnings to combined fixed charges and preferred stock dividends to earnings for each of the
periods presented. Our net losses were insufficient to cover fixed charges and combined fixed
charges and preferred stock dividends in each of the years ended December 31, 2003, 2004, 2005,
2006 and 2007 and in the nine months ended September 30, 2008. Because of these deficiencies, the
ratio information is not applicable for those periods. The extent to which earnings were
insufficient to cover fixed charges and combined fixed charges and preferred stock dividends for
those periods is shown below. Amounts shown are in millions, except for ratios.
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Nine Months |
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Ended |
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Year Ended December 31, |
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September 30, |
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2003 |
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2004 |
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2005 |
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2006 |
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2007 |
|
2008 |
Ratio of earnings to fixed charges |
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N/A |
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|
N/A |
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|
|
N/A |
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|
|
N/A |
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N/A |
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N/A |
|
Ratio of earnings to combined
fixed charges and preferred stock
dividends |
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N/A |
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N/A |
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|
|
N/A |
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|
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N/A |
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N/A |
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N/A |
|
Deficiency of earnings available
to cover fixed charges |
|
$ |
2.1 |
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|
$ |
9.1 |
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$ |
13.3 |
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|
$ |
14.8 |
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|
$ |
23.9 |
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$ |
31.8 |
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Deficiency of earnings available
to cover combined fixed charges
and preferred stock dividends |
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$ |
2.1 |
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$ |
9.1 |
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$ |
13.3 |
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$ |
14.8 |
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$ |
23.9 |
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$ |
31.8 |
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Our
ratio of earnings to fixed charges for each of the five most recently
completed fiscal years and any required interim periods will each be
specified in a prospectus supplement or in a document that we file
with the SEC and incorporate by reference pertaining to the
issuance, if any, by us of debt securities in the future.
USE OF PROCEEDS
Except as described in any applicable prospectus supplement and in any free writing
prospectuses in connection with a specific offering, we currently intend to use the net proceeds
from the sale of the securities offered hereby for operating costs, capital expenditures and for
general corporate purposes, including working capital. We may also use a portion of the net
proceeds to invest in or acquire businesses or technologies that we believe are complementary to
our own, although we have no current plans, commitments or agreements with respect to any
acquisitions as of the date of this prospectus. Pending these uses, we intend to invest the net
proceeds in investment-grade, interest-bearing securities.
15
DESCRIPTION OF CAPITAL STOCK
As of the date of this prospectus, our certificate of incorporation authorizes us to issue
150,000,000 shares of common stock, par value $0.001 per share, and 20,000,000 shares of preferred
stock, par value $0.001 per share. As of November 21, 2008, approximately 81.5 million shares of
common stock were outstanding and no shares of Preferred Stock were outstanding. Our board of
directors has previously designated 500,000 of the 20,000,000 authorized shares of preferred stock
as Series A Preferred Stock.
The following summary describes the material terms of our capital stock. The description of
our capital stock is qualified by reference to our amended and restated certificate of
incorporation, as amended, our bylaws, as amended, the certificate of designation for our Series A
Preferred Stock, which are incorporated by reference as exhibits into the registration statement of
which this prospectus is a part.
Common Stock
The holders of common stock are entitled to one vote for each share held of record on all
matters submitted to a vote of the stockholders. Subject to preferences that may be applicable to
any outstanding shares of the preferred stock, the holders of common stock are entitled to receive
ratably such dividends as may be declared by the board of directors out of funds legally available
therefor. In the event of a liquidation, dissolution or winding up of our company, holders of the
common stock are entitled to share ratably in all assets remaining after payment of liabilities and
the liquidation preferences of any outstanding shares of preferred stock. Holders of common stock
have no preemptive rights and no right to convert their common stock into any other securities.
There are no redemption or sinking fund provisions applicable to the common stock. All outstanding
shares of common stock are, and all shares of common stock to be outstanding upon the closing of
this offering will be, fully paid and nonassessable.
Additional shares of authorized common stock may be issued, as authorized by our board of
directors from time to time, without stockholder approval, except as may be required by applicable
stock exchange requirements.
Preferred Stock
Pursuant to our Amended and Restated Certificate of Incorporation, or the Restated
Certificate, our board of directors currently has the authority, without further action by the
stockholders, to issue up to 19,500,000 shares of preferred stock in one or more series and to fix
the designations, powers, preferences, privileges and relative participating, optional or special
rights and the qualifications, limitations or restrictions thereof, including dividend rights,
conversion rights, voting rights, terms of redemption and liquidation preferences, any or all of
which may be greater than the rights of the common stock. The board of directors, without
stockholder approval, can issue preferred stock with voting, conversion or other rights that could
adversely affect the voting power and other rights of the holders of common stock. Preferred stock
could thus be issued quickly with terms calculated to delay or prevent a change in control of our
company or make removal of management more difficult. Additionally, the issuance of preferred stock
may have the effect of decreasing the market price of the common stock and may adversely affect the
voting power of holders of common stock and reduce the likelihood that common stockholders will
receive dividend payments and payments upon liquidation.
Future Preferred Stock. Our board of directors will fix the rights, preferences, privileges,
qualifications and restrictions of the preferred stock of each series that we sell under this
prospectus and applicable prospectus supplements in the certificate of designation relating to that
series. We will incorporate by reference into the registration statements of which this prospectus
is a part the form of any certificate of designation that describes the terms of the series of
preferred stock we are offering before the issuance of the related series of preferred stock. This
description will include:
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the title and stated value; |
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the number of shares we are offering; |
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the liquidation preference per share; |
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the purchase price per share; |
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the dividend rate per share, dividend period and payment dates and method of calculation for dividends; |
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whether dividends will be cumulative or non-cumulative and, if
cumulative, the date from which dividends will accumulate; |
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our right, if any, to defer payment of dividends and the maximum length of any such deferral period; |
16
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the procedures for any auction and remarketing, if any; |
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the provisions for a sinking fund, if any; |
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the provisions for redemption or repurchase, if applicable, and any
restrictions on our ability to exercise those redemption and
repurchase rights; |
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any listing of the preferred stock on any securities exchange or market; |
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whether the preferred stock will be convertible into our common stock
or other securities of ours, including warrants, and, if applicable,
the conversion period, the conversion price, or how it will be
calculated, and under what circumstances it may be adjusted; |
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whether the preferred stock will be exchangeable into debt securities,
and, if applicable, the exchange period, the exchange price, or how it
will be calculated, and under what circumstances it may be adjusted; |
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voting rights, if any, of the preferred stock; |
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preemption rights, if any; |
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restrictions on transfer, sale or other assignment, if any; |
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a discussion of any material or special United States federal income
tax considerations applicable to the preferred stock; |
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the relative ranking and preferences of the preferred stock as to
dividend rights and rights if we liquidate, dissolve or wind up our
affairs; |
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any limitations on issuances of any class or series of preferred stock
ranking senior to or on a parity with the series of preferred stock
being issued as to dividend rights and rights if we liquidate,
dissolve or wind up our affairs; and |
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any other specific terms, rights, preferences, privileges, qualifications or restrictions of the preferred stock. |
When we issue shares of preferred stock under this prospectus, the shares will be fully paid
and nonassessable and will not have, or be subject to, any preemptive or similar rights.
The General Corporation Law of the State of Delaware, the state of our incorporation, provides
that the holders of preferred stock will have the right to vote separately as a class on any
proposal involving fundamental changes in the rights of holders of that preferred stock. This right
is in addition to any voting rights that may be provided for in the applicable certificate of
designation.
Antitakeover Effects of Provisions of Charter Documents and Delaware Law
Charter Documents. Our Restated Certificate and Amended and Restated Bylaws, or Bylaws,
include a number of provisions that may have the effect of deterring hostile takeovers or delaying
or preventing changes in control or management of our company. First, our board of directors is
classified into three classes of directors. Under Delaware law, directors of a corporation with a
classified board may be removed only for cause unless the corporations certificate of
incorporation provides otherwise. Our Restated Certificate does not provide otherwise. In addition,
the Restated Certificate provides that all stockholder action must be effected at a duly called
meeting of stockholders and not by a consent in writing. Further, our Bylaws limit who may call
special meetings of the stockholders. Our Restated Certificate does not include a provision for
cumulative voting for directors. Under cumulative voting, a minority stockholder holding a
sufficient percentage of a class of shares may be able to ensure the election of one or more
directors. Finally, our Bylaws establish procedures, including advance notice procedures, with
regard to the nomination of candidates for election as directors and stockholder proposals. These
and other provisions of our Restated Certificate and Bylaws and Delaware law could discourage
potential acquisition proposals and could delay or prevent a change in control or management of our
company.
17
Delaware Takeover Statute. We are subject to Section 203 of the General Corporation Law of the
State of Delaware, or DGCL,
which regulates acquisitions of some Delaware corporations. In general, Section 203 prohibits,
with some exceptions, a publicly held Delaware corporation from engaging in a business
combination with an interested stockholder for a period of three years following the date of the
transaction in which the person became an interested stockholder, unless:
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the board of directors of the corporation approved the business
combination or the other transaction in which the person became an
interested stockholder prior to the date of the business combination
or other transaction; |
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upon consummation of the transaction that resulted in the person
becoming an interested stockholder, the person owned at least 85% of
the voting stock of the corporation outstanding at the time the
transaction commenced, excluding shares owned by persons who are
directors and also officers of the corporation and shares issued under
employee stock plans under which employee participants do not have the
right to determine confidentially whether shares held subject to the
plan will be tendered in a tender or exchange offer; or |
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on or subsequent to the date the person became an interested
stockholder, the board of directors of the corporation approved the
business combination and the stockholders of the corporation
authorized the business combination at an annual or special meeting of
stockholders by the affirmative vote of at least 66-2/3% of the
outstanding stock of the corporation not owned by the interested
stockholder. |
Section 203 of the DGCL generally defines a business combination to include any of the
following:
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any merger or consolidation involving the corporation and the interested stockholder; |
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any sale, transfer, pledge or other disposition of 10% or more of the
corporations assets or outstanding stock involving the interested
stockholder; |
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in general, any transaction that results in the issuance or transfer
by the corporation of any of its stock to the interested stockholder; |
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any transaction involving the corporation that has the effect of
increasing the proportionate share of its stock owned by the
interested stockholder; or |
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the receipt by the interested stockholder of the benefit of any loans,
advances, guarantees, pledges or other financial benefits provided by
or through the corporation. |
In general, Section 203 defines an interested stockholder as any person who, together with
the persons affiliates and associates, owns, or within three years prior to the determination of
interested stockholder status did own, 15% or more of a corporations voting stock.
Section 203 of the DGCL could depress our stock price and delay, discourage or prohibit
transactions not approved in advance by our board of directors, such as takeover attempts that
might otherwise involve the payment to our stockholders of a premium over the market price of our
common stock.
Transfer Agent And Registrar
The transfer agent and registrar for our common stock is Corporate Stock Transfer Company.
Listing on The Nasdaq Global Market
Our common stock is listed on The Nasdaq Global Market under the symbol HALO.
18
DESCRIPTION OF DEBT SECURITIES
The following description, together with the additional information we include in any
applicable prospectus supplements or free writing prospectuses, summarizes the material terms and
provisions of the debt securities that we may offer under this prospectus. We may issue debt
securities, in one or more series, as either senior or subordinated debt or as senior or
subordinated convertible debt. While the terms we have summarized below will apply generally to any
future debt securities we may offer under this prospectus, we will describe the particular terms of
any debt securities that we may offer in more detail in the applicable prospectus supplement or
free writing prospectus. The terms of any debt securities we offer under a prospectus supplement
may differ from the terms we describe below. However, no prospectus supplement shall fundamentally
change the terms that are set forth in this prospectus or offer a security that is not registered
and described in this prospectus at the time of its effectiveness. As of the date of this
prospectus, we have no outstanding registered debt securities. Unless the context requires
otherwise, whenever we refer to the indentures, we also are referring to any supplemental
indentures that specify the terms of a particular series of debt securities.
We will issue any senior debt securities under the senior indenture that we will enter into
with the trustee named in the senior indenture. We will issue any subordinated debt securities
under the subordinated indenture that we will enter into with the trustee named in the subordinated
indenture. We have filed forms of these documents as exhibits to the registration statement, of
which this prospectus is a part, and supplemental indentures and forms of debt securities
containing the terms of the debt securities being offered will be filed as exhibits to the
registration statement of which this prospectus is a part or will be incorporated by reference from
reports that we file with the SEC.
The indentures will be qualified under the Trust Indenture Act of 1939, as amended, or the
Trust Indenture Act. We use the term trustee to refer to either the trustee under the senior
indenture or the trustee under the subordinated indenture, as applicable.
The following summaries of material provisions of the senior debt securities, the subordinated
debt securities and the indentures are subject to, and qualified in their entirety by reference to,
all of the provisions of the indenture applicable to a particular series of debt securities. We
urge you to read the applicable prospectus supplements and any related free writing prospectuses
related to the debt securities that we may offer under this prospectus, as well as the complete
indentures that contains the terms of the debt securities. Except as we may otherwise indicate, the
terms of the senior indenture and the subordinated indenture are identical.
General
The terms of each series of debt securities will be established by or pursuant to a resolution
of our board of directors and set forth or determined in the manner provided in an officers
certificate or by a supplement indenture. Debt securities may be issued in separate series without
limitation as to aggregate principal amount. We may specify a maximum aggregate principal amount
for the debt securities of any series. We will describe in the applicable prospectus supplement the
terms of the series of debt securities being offered, including:
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the title; |
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the principal amount being offered, and if a series, the total amount authorized and the total amount outstanding; |
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any limit on the amount that may be issued; |
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whether or not we will issue the series of debt securities in global
form, and, if so, the terms and who the depositary will be; |
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the maturity date; |
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whether and under what circumstances, if any, we will pay additional
amounts on any debt securities held by a person who is not a United
States person for tax purposes, and whether we can redeem the debt
securities if we have to pay such additional amounts; |
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the annual interest rate, which may be fixed or variable, or the
method for determining the rate and the date interest will begin to
accrue, the dates interest will be payable and the regular record
dates for interest payment dates or the method for determining such
dates; |
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whether or not the debt securities will be secured or unsecured, and the terms of any secured debt; |
19
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the terms of the subordination of any series of subordinated debt; |
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the place where payments will be payable; |
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restrictions on transfer, sale or other assignment, if any; |
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our right, if any, to defer payment of interest and the maximum length of any such deferral period; |
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the date, if any, after which, and the price at which, we may, at our
option, redeem the series of debt securities pursuant to any optional
or provisional redemption provisions and the terms of those redemption
provisions; |
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the date, if any, on which, and the price at which we are obligated,
pursuant to any mandatory sinking fund or analogous fund provisions or
otherwise, to redeem, or at the holders option, to purchase, the
series of debt securities and the currency or currency unit in which
the debt securities are payable; |
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whether the indenture will restrict our ability or the ability of our subsidiaries to: |
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incur additional indebtedness; |
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issue additional securities; |
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create liens; |
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pay dividends or make distributions in respect of our capital stock or the capital stock of our subsidiaries; |
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redeem capital stock; |
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place restrictions on our subsidiaries ability to pay dividends, make distributions or transfer assets; |
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make investments or other restricted payments; |
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sell or otherwise dispose of assets; |
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enter into sale-leaseback transactions; |
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engage in transactions with stockholders or affiliates; |
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issue or sell stock of our subsidiaries; or |
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effect a consolidation or merger; |
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whether the indenture will require us to maintain any interest
coverage, fixed charge, cash flow-based, asset-based or other
financial ratios; |
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a discussion of certain material or special United States federal
income tax considerations applicable to the debt securities; |
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information describing any book-entry features; |
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provisions for a sinking fund purchase or other analogous fund, if any; |
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the applicability of the provisions in the indenture on discharge; |
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whether the debt securities are to be offered at a price such that
they will be deemed to be offered at an original issue discount as
defined in paragraph (a) of Section 1273 of the Internal Revenue Code
of 1986, as amended; |
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the denominations in which we will issue the series of debt
securities, if other than denominations of $1,000 and any integral
multiple thereof; |
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the currency of payment of debt securities if other than U.S. dollars
and the manner of determining the equivalent amount in
U.S. dollars; and |
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any other specific terms, preferences, rights or limitations of, or
restrictions on, the debt securities, including any additional events
of default or covenants provided with respect to the debt securities,
and any terms that may be required by us or advisable under applicable
laws or regulations. |
Conversion or Exchange Rights
We will set forth in the applicable prospectus supplement the terms on which a series of debt
securities may be convertible into or exchangeable for our common stock, our preferred stock or
other securities (including securities of a third-party). We will include provisions as to whether
conversion or exchange is mandatory, at the option of the holder or at our option. We may include
provisions pursuant to which the number of shares of our common stock, our preferred stock or other
securities (including securities of a third-party) that the holders of the series of debt
securities receive would be subject to adjustment.
Consolidation, Merger or Sale
Unless we provide otherwise in the prospectus supplement applicable to a particular series of
debt securities, the indentures will not contain any covenant that restricts our ability to merge
or consolidate, or sell, convey, transfer or otherwise dispose of all or substantially all of our
assets. However, any successor to or acquirer of such assets must assume all of our obligations
under the indentures or the debt securities, as appropriate. If the debt securities are convertible
into or exchangeable for our other securities or securities of other entities, the person with whom
we consolidate or merge or to whom we sell all of our property must make provisions for the
conversion of the debt securities into securities that the holders of the debt securities would
have received if they had converted the debt securities before the consolidation, merger or sale.
Events of Default under the Indenture
Unless we provide otherwise in the prospectus supplement applicable to a particular series of
debt securities, the following are events of default under the indentures with respect to any
series of debt securities that we may issue:
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if we fail to pay interest when due and payable and our failure
continues for 90 days and the time for payment has not been extended; |
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if we fail to pay the principal, premium or sinking fund payment, if
any, when due and payable at maturity, upon redemption or repurchase
or otherwise, and the time for payment has not been extended; |
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if we fail to observe or perform any other covenant contained in the
debt securities or the indentures, other than a covenant specifically
relating to another series of debt securities, and our failure
continues for 90 days after we receive notice from the trustee or we
and the trustee receive notice from the holders of at least 25% in
aggregate principal amount of the outstanding debt securities of the
applicable series; and |
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if specified events of bankruptcy, insolvency or reorganization occur. |
We will describe in each applicable prospectus supplement any additional events of default
relating to the relevant series of debt securities.
If an event of default with respect to debt securities of any series occurs and is continuing,
other than an event of default specified in the last bullet point above, the trustee or the holders
of at least 25% in aggregate principal amount of the outstanding debt securities of that series, by
notice to us in writing, and to the trustee if notice is given by such holders, may declare the
unpaid principal, premium, if any, and accrued interest, if any, due and payable immediately. If an
event of default specified in the last bullet
point above occurs with respect to us, the unpaid principal, premium, if any, and accrued
interest, if any, of each issue of debt securities then outstanding shall be due and payable
without any notice or other action on the part of the trustee or any holder.
21
The holders of a majority in principal amount of the outstanding debt securities of an
affected series may waive any default or event of default with respect to the series and its
consequences, except defaults or events of default regarding payment of principal, premium, if any,
or interest, unless we have cured the default or event of default in accordance with the indenture.
Any waiver shall cure the default or event of default.
Subject to the terms of the indentures, if an event of default under an indenture shall occur
and be continuing, the trustee will be under no obligation to exercise any of its rights or powers
under such indenture at the request or direction of any of the holders of the applicable series of
debt securities, unless such holders have offered the trustee reasonable indemnity or security
satisfactory to it against any loss, liability or expense. The holders of a majority in principal
amount of the outstanding debt securities of any series will have the right to 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, provided that:
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the direction so given by the holder is not in conflict with any law or the applicable indenture; and |
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subject to its duties under the Trust Indenture Act, the trustee need
not take any action that might involve it in personal liability or
might be unduly prejudicial to the holders not involved in the
proceeding. |
The indentures provide that if an event of default has occurred and is continuing, the trustee
will be required in the exercise of its powers to use the degree of care that a prudent person
would use in the conduct of its own affairs. The trustee, however, may refuse to follow any
direction that conflicts with law or the indenture, or that the trustee determines is unduly
prejudicial to the rights of any other holder of the relevant series of debt securities, or that
would involve the trustee in personal liability. Prior to taking any action under the indentures,
the trustee will be entitled to indemnification against all costs, expenses and liabilities that
would be incurred by taking or not taking such action.
A holder of the debt securities of any series will have the right to institute a proceeding
under the indentures or to appoint a receiver or trustee, or to seek other remedies only if:
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the holder has given written notice to the trustee of a continuing event of default with respect to that series; |
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the holders of at least 25% in aggregate principal amount of the
outstanding debt securities of that series have made written request,
and such holders have offered reasonable indemnity to the trustee or
security satisfactory to it against any loss, liability or expense or
to be incurred in compliance with instituting the proceeding as
trustee; and |
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the trustee does not institute the proceeding, and does not receive
from the holders of a majority in aggregate principal amount of the
outstanding debt securities of that series other conflicting
directions within 90 days after the notice, request and offer. |
These limitations do not apply to a suit instituted by a holder of debt securities if we
default in the payment of the principal, premium, if any, or interest on, the debt securities, or
other defaults that may be specified in the applicable prospectus supplement.
We will periodically file statements with the trustee regarding our compliance with specified
covenants in the indentures.
The indentures provide that if a default occurs and is continuing and is actually known to a
responsible officer of the trustee, the trustee must mail to each holder notice of the default
within the earlier of 90 days after it occurs and 30 days after it is known by a responsible
officer of the trustee or written notice of it is received by the trustee, unless such default has
been cured or waived. Except in the case of a default in the payment of principal or premium of or
interest on any debt security or certain other defaults specified in an indenture, the trustee
shall be protected in withholding such notice if and so long as the board of directors, the
executive committee or a trust committee of directors, or responsible officers of the trustee, in
good faith determine that withholding notice is in the best interests of holders of the relevant
series of debt securities.
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Modification of Indenture; Waiver
Subject to the terms of the indenture for any series of debt securities that we may issue, we
and the trustee may change an indenture without the consent of any holders with respect to the
following specific matters:
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to fix any ambiguity, defect or inconsistency in the indenture; |
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to comply with the provisions described above under Description of Debt Securities Consolidation, Merger or Sale; |
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to comply with any requirements of the SEC in connection with the
qualification of any indenture under the Trust Indenture Act; |
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to add to, delete from or revise the conditions, limitations, and
restrictions on the authorized amount, terms, or purposes of issue,
authentication and delivery of debt securities, as set forth in the
indenture; |
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to provide for the issuance of and establish the form and terms and
conditions of the debt securities of any series as provided under
Description of Debt Securities General, to establish the form of
any certifications required to be furnished pursuant to the terms of
the indenture or any series of debt securities, or to add to the
rights of the holders of any series of debt securities; |
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to evidence and provide for the acceptance of appointment hereunder by a successor trustee; |
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to provide for uncertificated debt securities and to make all appropriate changes for such purpose; |
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to add to our covenants such new covenants, restrictions, conditions
or provisions for the benefit of the holders, to make the occurrence,
or the occurrence and the continuance, of a default in any such
additional covenants, restrictions, conditions or provisions an event
of default or to surrender any right or power conferred to us in the
indenture; or |
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to change anything that does not adversely affect the interests of any
holder of debt securities of any series in any material respect. |
In addition, under the indentures, 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, subject to the terms of the indenture for any series of debt securities that we may issue
or otherwise provided in the prospectus supplement applicable to a particular series of debt
securities, we and the trustee may only make the following changes with the consent of each holder
of any outstanding debt securities affected:
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extending the stated 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 reducing any premium payable upon the
redemption or repurchase 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, supplement, modification or
waiver. |
Discharge
Each indenture provides that, subject to the terms of the indenture and any limitation
otherwise provided in the prospectus supplement applicable to a particular series of debt
securities, we can elect to be discharged from our obligations with respect to one or more series
of debt securities, except for specified obligations, including obligations to:
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register the transfer or exchange of debt securities of the series; |
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replace stolen, lost or mutilated debt securities of the series; |
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maintain paying agencies; |
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hold monies for payment in trust; |
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recover excess money held by the trustee; |
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compensate and indemnify the trustee; and |
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appoint any successor trustee. |
In order to exercise our rights to be discharged, we must deposit with the trustee money or
government obligations sufficient to pay all the principal of, any premium and interest on, the
debt securities of the series on the dates payments are due.
Form, Exchange and Transfer
We will issue the debt securities of each series only in fully registered form without coupons
and, unless we otherwise specify in the applicable prospectus supplement, in denominations of
$1,000 and any integral multiple thereof. The indentures provide that we may issue debt securities
of a series in temporary or permanent global form and as book-entry securities that will be
deposited with, or on behalf of, The Depository Trust Company or another depositary named by us and
identified in a prospectus supplement with respect to that series. See Legal Ownership of
Securities below for a further description of the terms relating to any book-entry securities.
At the option of the holder, subject to the terms of the indentures and the limitations
applicable to global securities described in the applicable prospectus supplement, the holder of
the debt securities of any series can exchange the debt securities for other debt securities of the
same series, in any authorized denomination and of like tenor and aggregate principal amount.
Subject to the terms of the indentures and the limitations applicable to global securities set
forth in the applicable prospectus supplement, holders of the debt securities may present the debt
securities for exchange or for registration of transfer, duly endorsed or with the form of transfer
endorsed thereon duly executed if so required by us or the security registrar, at the office of the
security registrar or at the office of any transfer agent designated by us for this purpose. Unless
otherwise provided in the debt securities that the holder presents for transfer or exchange, we
will make no service charge for any registration of transfer or exchange, but we may require
payment of any taxes or other governmental charges.
We will name in the applicable prospectus supplement the security registrar, and any transfer
agent in addition to the security registrar, that we initially designate for any debt securities.
We may at any time designate additional transfer agents or rescind the designation of any transfer
agent or approve a change in the office through which any transfer agent acts, except that we will
be required to maintain a transfer agent in each place of payment for the debt securities of each
series.
If we elect to redeem the debt securities of any series, we will not be required to:
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issue, register the transfer of, or exchange any debt securities of
that series during a period beginning at the opening of business
15 days before the day of mailing of a notice of redemption of any
debt securities that may be selected for redemption and ending at the
close of business on the day of the mailing; or |
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register the transfer of or exchange any debt securities so selected
for redemption, in whole or in part, except the unredeemed portion of
any debt securities we are redeeming in part. |
Information Concerning the Trustee
The trustee, other than during the occurrence and continuance of an event of default under an
indenture, undertakes to perform only those duties as are specifically set forth in the applicable
indenture and is under no obligation to exercise any of the powers given it by the indentures at
the request of any holder of debt securities unless it is offered reasonable security and indemnity
against the costs, expenses and liabilities that it might incur. However, upon an event of default
under an indenture, the trustee must use the same degree of care as a prudent person would exercise
or use in the conduct of his or her own affairs.
Payment and Paying Agents
Unless we otherwise indicate in the applicable prospectus supplement, we will make payment of
the interest on any debt securities on any interest payment date to the person in whose name the
debt securities, or one or more predecessor securities, are registered at the close of business on
the regular record date for the interest.
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We will pay principal of and any premium and interest on the debt securities of a particular
series at the office of the paying agents designated by us, except that unless we otherwise
indicate in the applicable prospectus supplement, we will make interest payments by check that we
will mail to the holder or by wire transfer to certain holders. Unless we otherwise indicate in the
applicable prospectus supplement, we will designate the corporate trust office of the trustee as
our sole paying agent for payments with respect to debt securities of each series. We will name in
the applicable prospectus supplement any other paying agents that we initially designate for the
debt securities of a particular series. We will maintain a paying agent in each place of payment
for the debt securities of a particular series.
All money we pay to a paying agent or the trustee for the payment of the principal of or any
premium or interest on any debt securities that remains unclaimed at the end of two years after
such principal, premium or interest has become due and payable will be repaid to us, and the holder
of the debt security thereafter may look only to us for payment thereof.
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, except to the extent that the Trust Indenture Act is applicable.
Ranking Debt Securities
The subordinated debt securities will be unsecured and will be subordinate and junior in
priority of payment to certain other indebtedness to the extent described in a prospectus
supplement. The subordinated indenture does not limit the amount of subordinated debt securities
that we may issue. It also does not limit us from issuing any other secured or unsecured debt.
The senior debt securities will be unsecured and will rank equally in right of payment to all
our other senior unsecured debt. The senior indenture does not limit the amount of senior debt
securities that we may issue. It also does not limit us from issuing any other secured or unsecured
debt.
Existing Subordinated Debt
As of November 28, 2008, the Company had no existing subordinated debt.
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DESCRIPTION OF WARRANTS
The following description, together with the additional information we may include in any
applicable prospectus supplements and free writing prospectuses, summarizes the material terms and
provisions of the warrants that we may offer under this prospectus, which may consist of warrants
to purchase common stock, preferred stock or debt securities and may be issued in one or more
series. Warrants may be offered independently or together with common stock, preferred stock or
debt securities offered by any prospectus supplement, and may be attached to or separate from those
securities. While the terms we have summarized below will apply generally to any warrants that we
may offer under this prospectus, we will describe the particular terms of any series of warrants
that we may offer in more detail in the applicable prospectus supplement and any applicable free
writing prospectus. The terms of any warrants offered under a prospectus supplement may differ from
the terms described below. However, no prospectus supplement will fundamentally change the terms
that are set forth in this prospectus or offer a security that is not registered and described in
this prospectus at the time of its effectiveness.
We will issue the warrants under a warrant agreement that we will enter into with a warrant
agent to be selected by us. The warrant agent will act solely as an agent of ours in connection
with the warrants and will not act as an agent for the holders or beneficial owners of the
warrants. We will file as exhibits to the registration statement of which this prospectus is a
part, or will incorporate by reference from a current report on Form 8-K that we file with the SEC,
the form of warrant agreement, including a form of warrant certificate, that describes the terms of
the particular series of warrants we are offering before the issuance of the related series of
warrants. The following summaries of material provisions of the warrants and the warrant agreements
are subject to, and qualified in their entirety by reference to, all the provisions of the warrant
agreement and warrant certificate applicable to a particular series of warrants. We urge you to
read the applicable prospectus supplement and any applicable free writing prospectus related to the
particular series of warrants that we sell under this prospectus, as well as the complete warrant
agreements and warrant certificates that contain the terms of the warrants.
General
We will describe in the applicable prospectus supplement the terms relating to a series of
warrants, including:
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the offering price and aggregate number of warrants offered; |
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the currency for which the warrants may be purchased; |
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if applicable, the designation and terms of the securities with which
the warrants are issued and the number of warrants issued with each
such security or each principal amount of such security; |
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if applicable, the date on and after which the warrants and the
related securities will be separately transferable; |
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in the case of warrants to purchase debt securities, the principal
amount of debt securities purchasable upon exercise of one warrant and
the price at, and currency in which, this principal amount of debt
securities may be purchased upon such exercise; |
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in the case of warrants to purchase common stock or preferred stock,
the number of shares of common stock or preferred stock, as the case
may be, purchasable upon the exercise of one warrant and the price at
which these shares may be purchased upon such exercise; |
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the effect of any merger, consolidation, sale or other disposition of
our business on the warrant agreements and the warrants; |
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the terms of any rights to redeem or call the warrants; |
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any provisions for changes to or adjustments in the exercise price or
number of securities issuable upon exercise of the warrants; |
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the dates on which the right to exercise the warrants will commence and expire; |
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the manner in which the warrant agreements and warrants may be modified; |
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United States federal income tax consequences of holding or exercising the warrants; |
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the terms of the securities issuable upon exercise of the warrants; and |
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any other specific terms, preferences, rights or limitations of or restrictions on the warrants. |
Before exercising their warrants, holders of warrants will not have any of the rights of
holders of the securities purchasable upon such exercise, including:
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in the case of warrants to purchase debt securities, the right to
receive payments of principal of, or premium, if any, or interest on,
the debt securities purchasable upon exercise or to enforce covenants
in the applicable indenture; or |
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in the case of warrants to purchase common stock or preferred stock,
the right to receive dividends, if any, or, payments upon our
liquidation, dissolution or winding up or to exercise voting rights,
if any. |
Exercise of Warrants
Each warrant will entitle the holder to purchase the securities that we specify in the
applicable prospectus supplement at the exercise price that we describe in the applicable
prospectus supplement. Unless we otherwise specify in the applicable prospectus supplement, holders
of the warrants may exercise the warrants at any time up to the specified time on the expiration
date that we set forth in the applicable prospectus supplement. After the close of business on the
expiration date, unexercised warrants will become void.
Holders of the warrants may exercise the warrants by delivering the warrant certificate
representing the warrants to be exercised together with specified information, and paying the
required amount to the warrant agent in immediately available funds, as provided in the applicable
prospectus supplement. We will set forth on the reverse side of the warrant certificate and in the
applicable prospectus supplement the information that the holder of the warrant will be required to
deliver to the warrant agent.
Upon receipt of the required payment and the warrant certificate properly completed and duly
executed at the corporate trust office of the warrant agent or any other office indicated in the
applicable prospectus supplement, we will issue and deliver the securities purchasable upon such
exercise. If fewer than all of the warrants represented by the warrant certificate are exercised,
then we will issue a new warrant certificate for the remaining amount of warrants. If we so
indicate in the applicable prospectus supplement, holders of the warrants may surrender securities
as all or part of the exercise price for warrants.
Enforceability of Rights by Holders of Warrants
Each warrant agent will act solely as our agent under the applicable warrant agreement and
will not assume any obligation or relationship of agency or trust with any holder of any warrant. A
single bank or trust company may act as warrant agent for more than one issue of warrants. A
warrant agent will have no duty or responsibility in case of any default by us under the applicable
warrant agreement or warrant, including any duty or responsibility to initiate any proceedings at
law or otherwise, or to make any demand upon us. Any holder of a warrant may, without the consent
of the related warrant agent or the holder of any other warrant, enforce by appropriate legal
action its right to exercise, and receive the securities purchasable upon exercise of, its
warrants.
Outstanding Warrants
As of November 21, 2008, warrants to purchase an aggregate of approximately 3.3 million shares
of our common stock were outstanding. These warrants were issued in connection with previous
financing events conducted by our predecessor company.
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DESCRIPTION OF UNITS
The following description, together with the additional information we may include in any
applicable prospectus supplements, summarizes the material terms and provisions of the units that
we may offer under this prospectus. While the terms we have summarized below will apply generally
to any units that we may offer under this prospectus, we will describe the particular terms of any
series of units in more detail in the applicable prospectus supplement. The terms of any units
offered under a prospectus supplement may differ from the terms described below. However, no
prospectus supplement will fundamentally change the terms that are set forth in this prospectus or
offer a security that is not registered and described in this prospectus at the time of its
effectiveness.
We will file as exhibits to the registration statement of which this prospectus is a part, or
will incorporate by reference from a current report on Form 8-K that we file with the SEC, the form
of unit agreement that describes the terms of the series of units we are offering, and any
supplemental agreements, before the issuance of the related series of units. The following
summaries of material terms and provisions of the units are subject to, and qualified in their
entirety by reference to, all the provisions of the unit agreement and any supplemental agreements
applicable to a particular series of units. We urge you to read the applicable prospectus
supplements related to the particular series of units that we sell under this prospectus, as well
as the complete unit agreement and any supplemental agreements that contain the terms of the units.
General
We may issue units comprised of one or more debt securities, shares of common stock, shares of
preferred stock and warrants in any combination. Each unit will be issued so that the holder of the
unit is also the holder of each security included in the unit. Thus, the holder of a unit will have
the rights and obligations of a holder of each included security. The unit agreement under which a
unit is issued may provide that the securities included in the unit may not be held or transferred
separately, at any time or at any time before a specified date.
We will describe in the applicable prospectus supplement the terms of the series of units,
including:
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the designation and terms of the units and of the securities
comprising the units, including whether and under what circumstances
those securities may be held or transferred separately; |
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any provisions of the governing unit agreement that differ from those described below; and |
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any provisions for the issuance, payment, settlement, transfer or
exchange of the units or of the securities comprising the units. |
The provisions described in this section, as well as those described under Description of
Capital Stock, Description of Debt Securities and Description of Warrants will apply to each
unit and to any common stock, preferred stock, debt security or warrant included in each unit,
respectively.
Issuance in Series
We may issue units in such amounts and in numerous distinct series as we determine.
Enforceability of Rights by Holders of Units
Each unit agent will act solely as our agent under the applicable unit agreement and will not
assume any obligation or relationship of agency or trust with any holder of any unit. A single bank
or trust company may act as unit agent for more than one series of units. A unit agent will have no
duty or responsibility in case of any default by us under the applicable unit agreement or unit,
including any duty or responsibility to initiate any proceedings at law or otherwise, or to make
any demand upon us. Any holder of a unit may, without the consent of the related unit agent or the
holder of any other unit, enforce by appropriate legal action its rights as holder under any
security included in the unit.
We, the unit agents and any of their agents may treat the registered holder of any unit
certificate as an absolute owner of the units evidenced by that certificate for any purpose and as
the person entitled to exercise the rights attaching to the units so requested, despite any notice
to the contrary. See Legal Ownership of Securities.
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LEGAL OWNERSHIP OF SECURITIES
We can issue securities in registered form or in the form of one or more global securities. We
describe global securities in greater detail below. We refer to those persons who have securities
registered in their own names on the books that we or any applicable trustee or depositary or
warrant agent maintain for this purpose as the holders of those securities. These persons are the
legal holders of the securities. We refer to those persons who, indirectly through others, own
beneficial interests in securities that are not registered in their own names, as indirect
holders of those securities. As we discuss below, indirect holders are not legal holders, and
investors in securities issued in book-entry form or in street name will be indirect holders.
Book-Entry Holders
We may issue securities in book-entry form only, as we will specify in the applicable
prospectus supplement. This means securities may be represented by one or more global securities
registered in the name of a financial institution that holds them as depositary on behalf of other
financial institutions that participate in the depositarys book-entry system. These participating
institutions, which are referred to as participants, in turn, hold beneficial interests in the
securities on behalf of themselves or their customers.
Only the person in whose name a security is registered is recognized as the holder of that
security. Global securities will be registered in the name of the depositary or its participants.
Consequently, for global securities, we will recognize only the depositary as the holder of the
securities, and we will make all payments on the securities to the depositary. The depositary
passes along the payments it receives to its participants, which in turn pass the payments along to
their customers who are the beneficial owners. The depositary and its participants do so under
agreements they have made with one another or with their customers; they are not obligated to do so
under the terms of the securities.
As a result, investors in a global security will not own securities directly. Instead, they
will own beneficial interests in a global security, through a bank, broker or other financial
institution that participates in the depositarys book-entry system or holds an interest through a
participant. As long as the securities are issued in global form, investors will be indirect
holders, and not legal holders, of the securities.
Street Name Holders
We may terminate a global security or issue securities that are not issued in global form. In
these cases, investors may choose to hold their securities in their own names or in street name.
Securities held by an investor in street name would be registered in the name of a bank, broker or
other financial institution that the investor chooses, and the investor would hold only a
beneficial interest in those securities through an account he or she maintains at that institution.
For securities held in street name, we or any applicable trustee or depositary will recognize
only the intermediary banks, brokers and other financial institutions in whose names the securities
are registered as the holders of those securities, and we or any such trustee or depositary will
make all payments on those securities to them. These institutions pass along the payments they
receive to their customers who are the beneficial owners, but only because they agree to do so in
their customer agreements or because they are legally required to do so. Investors who hold
securities in street name will be indirect holders, not holders, of those securities.
Legal Holders
Our obligations, as well as the obligations of any applicable trustee or third party employed
by us or a trustee, run only to the legal holders of the securities. We do not have obligations to
investors who hold beneficial interests in global securities, in street name or by any other
indirect means. This will be the case whether an investor chooses to be an indirect holder of a
security or has no choice because we are issuing the securities only in global form.
For example, once we make a payment or give a notice to the holder, we have no further
responsibility for the payment or notice even if that holder is required, under agreements with its
participants or customers or by law, to pass it along to the indirect holders but does not do so.
Similarly, we may want to obtain the approval of the holders to amend an indenture, to relieve us
of the consequences of a default or of our obligation to comply with a particular provision of an
indenture, or for other purposes. In such an event, we would seek approval only from the legal
holders, and not the indirect holders, of the securities. Whether and how the holders contact the
indirect holders is up to the legal holders.
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Special Considerations for Indirect Holders
If you hold securities through a bank, broker or other financial institution, either in
book-entry form because the securities are represented by one or more global securities or in
street name, you should check with your own institution to find out:
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how it handles securities payments and notices; |
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whether it imposes fees or charges; |
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how it would handle a request for the holders consent, if ever required; |
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whether and how you can instruct it to send you securities registered
in your own name so you can be a holder, if that is permitted in the
future; |
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how it would exercise rights under the securities if there were a
default or other event triggering the need for holders to act to
protect their interests; and |
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if the securities are in book-entry form, how the depositarys rules and procedures will affect these matters. |
Global Securities
A global security is a security that represents one or any other number of individual
securities held by a depositary. Generally, all securities represented by the same global
securities will have the same terms.
Each security issued in book-entry form will be represented by a global security that we issue
to, deposit with and register in the name of a financial institution or its nominee that we select.
The financial institution that we select for this purpose is called the depositary. Unless we
specify otherwise in the applicable prospectus supplement, The Depository Trust Company, New York,
New York, known as DTC, will be the depositary for all securities issued in book-entry form.
A global security may not be transferred to or registered in the name of anyone other than the
depositary, its nominee or a successor depositary, unless special termination situations arise. We
describe those situations below under Special Situations When A Global Security Will Be
Terminated. As a result of these arrangements, the depositary, or its nominee, will be the sole
registered owner and legal holder of all securities represented by a global security, and investors
will be permitted to own only beneficial interests in a global security. Beneficial interests must
be held by means of an account with a broker, bank or other financial institution that in turn has
an account with the depositary or with another institution that does. Thus, an investor whose
security is represented by a global security will not be a legal holder of the security, but only
an indirect holder of a beneficial interest in the global security.
If the prospectus supplement for a particular security indicates that the security will be
issued as a global security, then the security will be represented by a global security at all
times unless and until the global security is terminated. If termination occurs, we may issue the
securities through another book-entry clearing system or decide that the securities may no longer
be held through any book-entry clearing system.
Special Considerations For Global Securities
As an indirect holder, an investors rights relating to a global security will be governed by
the account rules of the investors financial institution and of the depositary, as well as general
laws relating to securities transfers. We do not recognize an indirect holder as a holder of
securities and instead deal only with the depositary that holds the global security.
If securities are issued only as global securities, an investor should be aware of the
following:
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an investor cannot cause the securities to be registered in his or her
name, and cannot obtain non-global certificates for his or her
interest in the securities, except in the special situations we
describe below; |
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an investor will be an indirect holder and must look to his or her own
bank or broker for payments on the securities and protection of his or
her legal rights relating to the securities, as we describe above; |
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an investor may not be able to sell interests in the securities to
some insurance companies and to other institutions that are required
by law to own their securities in non-book-entry form; |
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an investor may not be able to pledge his or her interest in the
global security in circumstances where certificates representing the
securities must be delivered to the lender or other beneficiary of the
pledge in order for the pledge to be effective; |
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the depositarys policies, which may change from time to time, will
govern payments, transfers, exchanges and other matters relating to an
investors interest in the global security. We and any applicable
trustee have no responsibility for any aspect of the depositarys
actions or for its records of ownership interests in the global
security. We and the trustee also do not supervise the depositary in
any way; |
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the depositary may, and we understand that DTC will, require that
those who purchase and sell interests in the global security within
its book-entry system use immediately available funds, and your broker
or bank may require you to do so as well; and |
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financial institutions that participate in the depositarys book-entry
system, and through which an investor holds its interest in the global
security, may also have their own policies affecting payments, notices
and other matters relating to the securities. There may be more than
one financial intermediary in the chain of ownership for an investor.
We do not monitor and are not responsible for the actions of any of
those intermediaries. |
Special Situations When A Global Security Will Be Terminated
In a few special situations described below, a global security will terminate and interests in
it will be exchanged for physical certificates representing those interests. After that exchange,
the choice of whether to hold securities directly or in street name will be up to the investor.
Investors must consult their own banks or brokers to find out how to have their interests in
securities transferred to their own names, so that they will be direct holders. We have described
the rights of holders and street name investors above.
A global security will terminate when the following special situations occur:
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if the depositary notifies us that it is unwilling, unable or no
longer qualified to continue as depositary for that global security
and we do not appoint another institution to act as depositary within
90 days; |
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if we notify any applicable trustee that we wish to terminate that global security; or |
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if an event of default has occurred with regard to securities
represented by that global security and has not been cured or waived. |
The applicable prospectus supplement may also list additional situations for terminating a
global security that would apply only to the particular series of securities covered by the
prospectus supplement. When a global security terminates, the depositary, and neither we nor any
applicable trustee, is responsible for deciding the names of the institutions that will be the
initial direct holders.
31
PLAN OF DISTRIBUTION
We may sell the securities to or through underwriters or dealers, through agents, or directly
to one or more purchasers. A prospectus supplement or supplements (and any related free writing
prospectus that we may authorize to be provided to you) will describe the terms of the offering of
the securities, including, to the extent applicable:
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the name or names of any underwriters, if any; |
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the purchase price of the securities and the proceeds we will receive from the sale; |
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any over-allotment options under which underwriters may purchase additional securities from us; |
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any agency fees or underwriting discounts and other items constituting agents or underwriters compensation; |
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any public offering price; |
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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 may be listed. |
Only underwriters named in the prospectus supplement are underwriters of the securities
offered by the prospectus supplement.
If underwriters are used in the sale, they will acquire the securities for their own account
and may resell the securities from time to time in one or more transactions at a fixed public
offering price or at varying prices determined at the time of sale. The obligations of the
underwriters to purchase the securities will be subject to the conditions set forth in the
applicable underwriting agreement. We may offer the securities to the public through underwriting
syndicates represented by managing underwriters or by underwriters without a syndicate. Subject to
certain conditions, the underwriters will be obligated to purchase all of the securities offered by
the prospectus supplement. Any public offering price and any discounts or concessions allowed or
reallowed or paid to dealers may change from time to time. We may use underwriters with whom we
have a material relationship. We will describe in the prospectus supplement, naming the
underwriter, the nature of any such relationship.
We may sell securities directly or through agents we designate from time to time. We will name
any agent involved in the offering and sale of securities and we will describe any commissions we
will pay the agent in the prospectus supplement. Unless the prospectus supplement states otherwise,
our agent will act on a best-efforts basis for the period of its appointment.
We may authorize agents or underwriters to solicit offers by certain types of institutional
investors to purchase 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. We will describe the conditions to these contracts and the commissions we must
pay for solicitation of these contracts in the prospectus supplement.
We may provide agents and underwriters with indemnification against civil liabilities related
to this offering, including liabilities under the Securities Act, or contribution with respect to
payments that the agents or underwriters may make with respect to these liabilities. Agents and
underwriters may engage in transactions with, or perform services for, us in the ordinary course of
business.
All securities we offer, other than common stock, will be new issues of securities with no
established trading market. Any underwriters may make a market in these securities, but will not be
obligated to do so and may discontinue any market making at any time without notice. We cannot
guarantee the liquidity of the trading markets for any securities.
Any underwriter may engage in overallotment, stabilizing transactions, short covering
transactions and penalty bids in accordance with Regulation M under the Exchange Act. Overallotment
involves sales in excess of the offering size, which create a short position. Stabilizing
transactions permit bids 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. If commenced, the
underwriters may discontinue any of the activities at any time.
Any underwriters who are qualified market makers on The Nasdaq Global Market may engage in
passive market making transactions in the securities on The Nasdaq Global Market in accordance with
Rule 103 of Regulation M, during the business day prior to the pricing of the offering, before the
commencement of offers or sales of the securities. Passive market makers must comply with
applicable volume and price limitations and must be identified as passive market makers. In
general, a passive market maker must display its bid at a price not in excess of the highest
independent bid for such security; if all independent bids are lowered below the passive market
makers bid, however, the passive market makers bid must then be lowered when certain purchase
limits are exceeded.
In compliance with guidelines of the Financial Industry Regulatory Authority, or FINRA, the
maximum consideration or discount to be received by any FINRA member or independent broker dealer
may not exceed 8% of the aggregate amount of the securities offered pursuant to this prospectus and
any applicable prospectus supplement.
32
LEGAL MATTERS
DLA Piper LLP (US), San Diego, California will pass for us upon the validity of the securities
being offered by this prospectus and applicable prospectus supplement, and counsel named in the
applicable prospectus supplement will pass upon legal matters for any underwriters, dealers or
agents.
EXPERTS
The consolidated financial statements of Halozyme Therapeutics, Inc. appearing in Halozyme
Therapeutics, Inc.s Annual Report (Form 10-K) as of and for the years ended December 31, 2007 and
2006, and the effectiveness of Halozyme Therapeutics, Inc.s internal control over financial
reporting as of December 31, 2007, have been audited by Ernst & Young LLP, independent registered
public accounting firm, as set forth in their reports thereon, included therein, and incorporated
herein by reference. Such consolidated financial statements are incorporated herein by reference in
reliance upon such report given on the authority of such firm as experts in accounting and
auditing.
The consolidated financial statements of Halozyme Therapeutics, Inc. as of December 31, 2005,
and for the year then ended, have been incorporated by reference herein in reliance upon the report
of Cacciamatta Accountancy Corporation, independent registered public accounting firm, incorporated
by reference herein, and upon the authority of said firm as experts in accounting and auditing.
WHERE YOU CAN FIND MORE INFORMATION
We are a reporting company and file annual, quarterly and current reports, proxy statements
and other information with the SEC. We have filed with the SEC a registration statement on Form S-3
under the Securities Act with respect to the securities we are offering under this prospectus. This
prospectus does not contain all of the information set forth in the registration statement and the
exhibits to the registration statement. For further information with respect to us and the
securities we are offering under this prospectus, we refer you to the registration statement and
the exhibits and schedules filed as a part of the registration statement. You may read and copy the
registration statement, as well as our reports, proxy statements and other information, at the
SECs Public Reference Room at 100 F Street, N.E., Washington, D.C. 20549. You can request copies
of these documents by writing to the SEC and paying a fee for the copying cost. Please call the SEC
at 1-800-SEC-0330 for more information about the operation of the Public Reference Room. The SEC
maintains an internet site that contains reports, proxy and information statements, and other
information regarding issuers that file electronically with the SEC,
where our SEC filings are also
available. The address of the SECs web site is http://www.sec.gov. We maintain a website at
www.halozyme.com. Information contained in or accessible through our website does not constitute a
part of this prospectus.
33
INCORPORATION BY REFERENCE
The SEC allows us to incorporate by reference information that we file with it into this
prospectus, which means that we can disclose important information to you by referring you to those
documents. The information incorporated by reference is an important part of this prospectus.
Information in this prospectus supersedes information incorporated by reference that we filed with
the SEC prior to the date of this prospectus, while information that we file later with the SEC
will automatically update and supersede the information in this prospectus. We incorporate by
reference into this registration statement and prospectus the documents listed below, and any
future filings we will make with the SEC under Sections 13(a), 13(c), 14 or 15(d) of the Exchange
Act after the date of the initial registration statement but prior to effectiveness of the
registration statement and after the date of this prospectus but prior to the termination of the
offering of the securities covered by this prospectus (other than current reports or portions
thereof furnished under Item 2.02 or Item 7.01 of Form 8-K):
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Our Quarterly Report on Form 10-Q for the quarter ended September 30, 2008; |
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Our Quarterly Report on Form 10-Q for the quarter ended June 30, 2008; |
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Our Quarterly Report on Form 10-Q for the quarter ended March 31, 2008; |
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Our Annual Report on Form 10-K for the year ended December 31, 2007; |
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Our Current Reports on Form 8-K filed on February 8, 2008; March 19,
2008; April 21, 2008; August 21, 2008; and November 7, 2008; |
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Our definitive proxy statement filed pursuant to Section 14 of the
Exchange Act in connection with our 2008 Annual Meeting of
Stockholders filed with the SEC on April 3, 2008; and |
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The description of our common stock set forth in Form 8-A/A, filed with the SEC on November 20, 2007. |
We will provide to each person, including any beneficial owner, to whom a prospectus is
delivered, without charge upon written or oral request, a copy of any or all of the information
that has been incorporated by reference into this prospectus but not delivered with the prospectus,
including exhibits that are specifically incorporated by reference into such documents. Requests
should be directed to: Halozyme Therapeutics, Inc., Attention: Investor Relations, 11388 Sorrento
Valley Road, San Diego, CA 92121, telephone: (858) 794-8889.
DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION FOR
SECURITIES ACT LIABILITY
Insofar as indemnification for liabilities arising under the Securities Act may be permitted
to directors, officers or persons controlling the registrant pursuant to the foregoing provisions,
the registrant has been informed that in the opinion of the Securities and Exchange Commission such
indemnification is against public policy as expressed in the Securities Act and is, therefore,
unenforceable.
34
HALOZYME THERAPEUTICS, INC.
$50,000,000
Common Stock, Preferred Stock,
Debt Securities,
Warrants and Units
PROSPECTUS
, 20___
PART II
INFORMATION NOT REQUIRED IN THE PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution
The following table sets forth the estimated costs and expenses, other than underwriting
discounts and commissions, payable by the registrant in connection with the offering of the
securities being registered. All the amounts shown are estimates, except for the SEC registration
fee.
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SEC registration fee |
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$ |
1,965 |
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Accounting fees and expenses |
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20,000 |
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Legal fees and expenses |
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15,000 |
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Printing and miscellaneous expenses |
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10,000 |
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Total |
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$ |
46,965 |
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Item 15. Indemnification of Officers and Directors
Section 102(b)(7) of the General Corporation Law of the State of Delaware, or DGCL, permits a
Delaware corporation to limit the personal liability of its directors in accordance with the
provisions set forth therein. Our amended and restated certificate of incorporation, as amended,
provides that the personal liability of our directors shall be limited to the fullest extent
permitted by applicable law.
Section 145 of the DGCL authorizes a court to award, or a corporations board of directors to
grant, indemnity to directors and officers in terms sufficiently broad to permit such
indemnification under certain circumstances for liabilities including reimbursement for expenses
incurred arising under the Securities Act of 1933. Our amended and restated certificate of
incorporation, as amended, and our amended and restated bylaws permit indemnification of directors,
officers, employees and other agents to the maximum extent permitted by Delaware law. In addition,
we have entered into indemnification agreements with each of our executive officers and directors.
We also maintain an officers and directors liability insurance policy.
The foregoing may reduce the likelihood of derivative litigation against our directors and
executive officers and may discourage or deter stockholders or management from suing directors or
executive officers for breaches of their duty of care, even though such actions, if successful,
might otherwise benefit the company and our stockholders.
The underwriting agreement that we may enter into, Exhibit 1.1 to this Registration Statement,
will provide for indemnification by any underwriters of the company, our directors, our officers
who sign the registration statement and our controlling persons, if any, for some liabilities,
including liabilities arising under the Securities Act.
Item 16. Exhibits and Financial Statement Schedules
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Exhibit |
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Number |
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Description of Document |
1.1
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Form of Underwriting Agreement (1) |
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4.1
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Form of Senior Debt Indenture |
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4.2
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Form of Subordinated Debt Indenture |
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4.3
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Certificate of Designation of Preferred Stock (1) |
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4.4
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Form of Senior Note (1) |
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4.5
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Form of Subordinated Note (1) |
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4.6
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Form of Warrant Agreement (1) |
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4.7
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Form of Unit Agreement (1) |
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5.1
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Opinion of DLA Piper LLP (US) |
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23.1
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Consent of Independent Registered Public Accounting Firm Ernst & Young LLP |
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23.2
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Consent of Independent Registered Public Accounting Firm Cacciamatta Accountancy Corporation |
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23.3
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Consent of DLA Piper LLP (US) (included in Exhibit 5.1) |
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24.1
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Power of Attorney (included on signature page) |
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(1) |
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To be filed as an exhibit to a Current Report of the registrant on Form 8-K and incorporated herein by reference. |
II- 1
Item 17. Undertakings
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:
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(i) |
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To include any prospectus required by Section 10(a)(3) of the Securities Act of 1933; |
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(ii) |
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To reflect in the prospectus any facts or events arising after the
effective date of the registration statement (or the most recent
post-effective amendment thereof) which, individually or in the
aggregate, represent a fundamental change in the information set
forth in the registration statement. Notwithstanding the foregoing,
any increase or decrease in volume of securities offered (if the
total dollar value of securities offered would not exceed that which
was registered) and any deviation from the low or high end of the
estimated maximum offering range may be reflected in the form of
prospectus filed with the Commission pursuant to Rule 424(b) if, in
the aggregate, the changes in volume and price represent no more than
20 percent change in the maximum aggregate offering price set forth
in the Calculation of Registration Fee table in the effective
registration statement; |
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(iii) |
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To include any material information with respect to the plan of
distribution not previously disclosed in the registration statement
or any material change to such information in the registration
statement; |
provided, however, that the undertakings set forth in paragraphs (1)(i), (1)(ii) and
(1)(iii) above do not apply if the registration statement is on Form S-3 or Form F-3 and the
information required to be included in a post-effective amendment by those paragraphs is contained
in reports filed with or furnished to the Commission by the registrant pursuant to Section 13 or
Section 15(d) of the Securities Exchange Act of 1934 that are incorporated by reference in the
registration statements or is contained in a form of prospectus filed pursuant to Rule 424(b) that
is part of the registration statement.
(2) That, for the purpose of determining any liability under the Securities Act of 1933, each
such post-effective amendment shall be deemed to be a new registration statement relating to the
securities offered therein, and the offering of such securities at that time shall be deemed to be
the initial bona fide offering thereof.
(3) To remove from registration by means of a post-effective amendment any of the securities
being registered which remain unsold at the termination of the offering.
(4) That, for the purpose of determining liability under the Securities Act of 1933 to any
purchaser:
(i) Each prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be
part of the registration statement as of the date the filed prospectus was deemed part of and
included in the registration statement; and
(ii) Each prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as
part of a registration statement in reliance on Rule 430B relating to an offering made pursuant to
Rule 415(a)(1)(i), (vii), or (x) for the purpose of providing the information required by
Section 10(a) of the Securities Act of 1933 shall be deemed to be part of and included in the
registration statement as of the earlier of the date such form of prospectus is first used after
effectiveness or the date of the first contract of sale of securities in the offering described in
the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that
is at that date an underwriter, such date shall be deemed to be a new effective date of the
registration statement relating to the securities in the registration statement to which that
prospectus relates, and the offering of such securities at that time shall be deemed to be the
initial bona fide offering thereof. Provided, however , that no statement made in a registration
statement or prospectus that is part of the registration statement or made in a document
incorporated or deemed incorporated by reference into the registration statement or prospectus that
is part of the registration statement will, as to a purchaser with a time of contract of sale prior
to such effective date, supersede or modify any statement that was made in the registration
statement or prospectus that was part of the registration statement or made in any such document
immediately prior to such effective date.
(5) That, for the purpose of determining liability of the registrant under the Securities Act
of 1933 to any purchaser in the initial distribution of the securities, the undersigned registrant
undertakes that in a primary offering of securities of the undersigned registrant pursuant to this
registration statement, regardless of the underwriting method used to sell the securities to the
purchaser, if the securities are offered or sold to such purchaser by means of any of the following
communications, the undersigned registrant will be a seller to the purchaser and will be considered
to offer or sell such securities to such purchaser: (i) any preliminary prospectus or prospectus of
the undersigned registrant relating to the offering required to be filed pursuant to Rule 424;
(ii) any free writing
prospectus relating to the offering prepared by or on behalf of the undersigned registrant or
used or referred to by the undersigned registrant; (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.
II- 2
(6) That, for purposes of determining any liability under the Securities Act of 1933, each
filing of the registrants annual report pursuant to Section 13(a) or 15(d) of the Securities
Exchange Act of 1934 (and, where applicable, each filing of an employee benefit plans annual
report pursuant to Section 15(d) of the Securities Exchange Act of 1934) that is incorporated by
reference in the registration statement shall be deemed to be a new registration statement relating
to the securities offered therein, and the offering of such securities at that time shall be deemed
to be the initial bona fide offering thereof.
(7) To deliver or cause to be delivered with the prospectus, to each person to whom the
prospectus is sent or given, the latest annual report to security holders that is incorporated by
reference in the prospectus and furnished pursuant to and meeting the requirements of Rule 14a-3 or
Rule 14c-3 under the Securities Exchange Act of 1934; and, where interim financial information
required to be presented by Article 3 of Regulation S-X are not set forth in the prospectus, to
deliver, or cause to be delivered to each person to whom the prospectus is sent or given, the
latest quarterly report that is specifically incorporated by reference in the prospectus to provide
such interim financial information.
(8) That for purposes of determining any liability under the Securities Act, (i) the
information omitted from the form of prospectus filed as part of the registration statement in
reliance upon Rule 430A and contained in the form of prospectus filed by the registrant pursuant to
Rule 424(b)(l) or (4) or 497(h) under the Securities Act shall be deemed to be a part of the
registration statement as of the time it was declared effective; and (ii) each post-effective
amendment that contains a form of prospectus shall be deemed to be a new registration statement
relating to the securities offered therein, and the offing of such securities at that time shall be
deemed to be the initial bona fide offering thereof.
(9) That, 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 Trust Indenture Act.
Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be
permitted to directors, officers and controlling persons of the registrant pursuant to the
foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the
Securities and Exchange Commission such indemnification is against public policy as expressed in
the 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 of 1933 and will be governed by the final adjudication of such issue.
II- 3
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, as amended, 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 San Diego, State of California, on
November 26, 2008.
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HALOZYME THERAPEUTICS, INC.
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BY:
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/s/ Jonathan E. Lim, M.D.
Jonathan E. Lim, M.D.
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President and Chief Executive Officer |
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(Principal Executive Officer) |
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POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below hereby
constitutes and appoints Jonathan E. Lim and David A. Ramsay, and each of them, his or her true and
lawful attorneys-in-fact and agents, with full power of substitution and resubstitution, for him or
her and in his or her name, place and stead, in any and all capacities including his or her
capacity as a director and/or officer of Halozyme Therapeutics, Inc., to sign any and all
amendments (including post-effective amendments) to this registration statement, and to file the
same, with all exhibits thereto, and other documents in connection therewith, with the Securities
and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full
power and authority to do and perform each and every act and thing requisite and necessary to be
done in and about the premises, as fully to all intents and purposes as he or she might or could do
in person, hereby ratifying and confirming all that said attorneys-in-fact and agents or any of
them, or their or his or her 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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Signature |
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Title |
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Date |
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/s/ Jonathan E. Lim, M.D.
Jonathan E. Lim, M.D. |
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President and Chief Executive Officer
(Principal Executive Officer),
Director
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November 26, 2008 |
/s/ David A. Ramsay
David A. Ramsay |
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Secretary and Chief Financial Officer
(Principal Financial and Accounting Officer)
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|
November 26, 2008 |
/s/ Gregory I. Frost, Ph.D.
Gregory I. Frost, Ph.D. |
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Vice President and Chief Scientific
Officer, Director
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|
November 26, 2008 |
/s/ Kenneth J. Kelley
Kenneth J. Kelley |
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Chairman of the Board of Directors
|
|
November 26, 2008 |
/s/ Robert L. Engler, M.D.
Robert L. Engler, M.D. |
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Director
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|
November 26, 2008 |
/s/ Kathryn E. Falberg
Kathryn E. Falberg |
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Director
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|
November 26, 2008 |
/s/ Randal J. Kirk
Randal J. Kirk |
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Director
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|
November 26, 2008 |
/s/ Connie Matsui
Connie Matsui |
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Director
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|
November 26, 2008 |
/s/ John S. Patton, Ph.D.
John S. Patton, Ph.D. |
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Director
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November 26, 2008 |
/s/ Steven T. Thornton
Steven T. Thornton |
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Director
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November 26, 2008 |
II- 4
INDEX TO EXHIBITS
|
|
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Exhibit |
|
|
Number |
|
Description of Document |
1.1
|
|
Form of Underwriting Agreement (1) |
|
|
|
4.1
|
|
Form of Senior Debt Indenture |
|
|
|
4.2
|
|
Form of Subordinated Debt Indenture |
|
|
|
4.3
|
|
Certificate of Designation of Preferred Stock (1) |
|
|
|
4.4
|
|
Form of Senior Note (1) |
|
|
|
4.5
|
|
Form of Subordinated Note (1) |
|
|
|
4.6
|
|
Form of Warrant Agreement (1) |
|
|
|
4.7
|
|
Form of Unit Agreement (1) |
|
|
|
5.1
|
|
Opinion of DLA Piper LLP (US) |
|
|
|
23.1
|
|
Consent of Independent Registered Public Accounting Firm Ernst & Young LLP |
|
|
|
23.2
|
|
Consent of Independent Registered Public Accounting Firm Cacciamatta Accountancy Corporation |
|
|
|
23.3
|
|
Consent of DLA Piper LLP (US) (included in Exhibit 5.1) |
|
|
|
24.1
|
|
Power of Attorney (included on signature page) |
|
|
|
(1) |
|
To be filed as an exhibit to a Current Report of the registrant on Form 8-K and incorporated herein by reference. |
II- 5