As
filed with the Securities and Exchange Commission on January 29,
2010.
Registration
No. 333-________
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
REGISTRATION
STATEMENT
UNDER
THE
SECURITIES ACT OF 1933
GENEREX
BIOTECHNOLOGY CORPORATION
(Exact
Name of Registrant as Specified in its Charter)
Delaware
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98-0178636
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(State
or Other Jurisdiction of
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(I.R.S.
Employer
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Incorporation
or Organization)
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Identification
Number)
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33
Harbour Square, Suite 202
Toronto,
Ontario
Canada
M5J 2G2
(416)
364-2551
(Address,
including zip code, and telephone number, including
area
code, of registrant’s principal executive offices)
Mark
Fletcher, Esquire
Executive
Vice President and General Counsel
33
Harbour Square, Suite 202
Toronto,
Ontario
Canada
M5J 2G2
(416)
364-2551
(Name,
address, including zip code, and telephone number,
including
area code, of agent for service)
Copy
of Communications to:
Gary
A. Miller
Eckert
Seamans Cherin & Mellott, LLC
Two
Liberty Place
50
South 16th Street, 22nd Floor
Philadelphia,
Pennsylvania 19102
(215)
851-8400
Approximate date of commencement of
proposed sale to the public:
From time to time after the effective date
of this registration statement.
If the
only securities being registered on this form are being offered pursuant to
dividend or interest reinvestment plans, please check the following box.
£
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, as
amended, or the Securities Act, other than securities offered only in connection
with dividend or interest reinvestment plans, check the following box.
R
If this
form is filed to register additional securities for an offering pursuant to Rule
462(b) under the Securities Act, please check the following box and list the
Securities Act registration statement number of the earlier effective
registration statement for the same offering.
£
If this
form is a post-effective amendment filed pursuant to Rule 462(c) under the
Securities Act, check the following box and list the Securities Act registration
statement number of the earlier effective registration statement for the same
offering.
£
If this
form is a registration statement pursuant to General Instruction I.D. or a
post-effective amendment thereto that shall be become effective upon filing with
the Commission pursuant to Rule 462(e) under the Securities Act, check the
following box.
£
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.
£
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
definitions of “large accelerated filer,” “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act. (Check
one):
Large
accelerated filer
o
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Accelerated
filer
o
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Non-accelerated
filer
o
(Do
not check if a smaller reporting
company)
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Smaller
reporting company
þ
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CALCULATION
OF REGISTRATION FEE
Title of Each Class of Securities to be Registered
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Amount To Be
Registered(1)
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Proposed
Maximum
Aggregate
Price per
Unit(2)
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Proposed
Maximum
Aggregate
Offering
Price(2)(3)
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Amount of
Registration
Fee(3)
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Common
Stock, par value $.001 per share (4)
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Preferred
Stock, par value $.001 per share (4)
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Warrants
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Units
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Total
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$
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150,000,000
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-
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$
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150,000,000
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$
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10,695
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(5)
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(1)
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The Registrant is registering an
indeterminate number of shares of common stock and preferred stock of
Generex Biotechnology Corporation (“Generex”), an indeterminate number of
warrants to purchase shares of common stock or preferred stock of Generex,
and an indeterminate number of units consisting of any two or more of the
other securities listed in the table above and sold together as shall have
an aggregate initial offering price not to exceed $150,000,000 or the
equivalent thereof in one or more
currencies.
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(2)
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Not specified as to each class of
securities to be registered hereunder pursuant to General Instruction
II.D. of Form S-3. Any securities registered hereunder may be sold
separately or as units with other securities registered hereunder. The
proposed maximum offering price per unit will be determined from time to
time by the Registrant in connection with, and at the time of the issuance
of the securities.
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(3)
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Estimated in accordance with Rule
457(o) solely for the purpose of calculation of the registration
fee.
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(4)
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Also includes an indeterminate
number of shares of common stock that may be issued upon conversion or
exercise, as applicable, of preferred stock or warrants registered
hereunder and an indeterminate number of shares of preferred stock that
may be issued upon exercise of warrants registered
hereunder.
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(5)
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$12,424
was previously paid which is in excess of the required filing
fee. Thus, the Registrant is not required to pay any additional
filing fee herewith. The Registrant previously paid a
registration fee of $16,050 pursuant to previously filed Registration
Statement on Form S-3, File No. 333-139637, as amended (the “Prior
Registration Statement”), originally filed with the Securities and
Exchange Commission on December 22, 2006 and subsequently declared
effective. Of the $150,000,000 of the Registrant’s securities registered
pursuant to the Prior Registration Statement, only $33,889,080 of its
securities were sold, resulting in an unused registration fee of $12,424.
Pursuant to Rule 415(a)(6) under the Securities Act, the registrant hereby
includes in this registration statement the $116,110,920 of securities
remaining unsold under the Prior Registration Statement. Pursuant to Rule
415(a)(6) the filing fee of $12,424 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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WE HEREBY
AMEND THIS REGISTRATION STATEMENT ON SUCH DATE OR DATES AS MAY BE NECESSARY TO
DELAY ITS EFFECTIVE DATE UNTIL WE FILE A FURTHER AMENDMENT WHICH SPECIFICALLY
STATES THAT THIS REGISTRATION STATEMENT SHALL THEREAFTER BECOME EFFECTIVE IN
ACCORDANCE WITH SECTION 8(a) OF THE SECURITIES ACT OF 1933 OR UNTIL THE
REGISTRATION STATEMENT SHALL BECOME EFFECTIVE ON SUCH DATE AS THE COMMISSION,
ACTING PURSUANT TO SAID SECTION 8(a), MAY DETERMINE.
EXPLANATORY
NOTE:
The
Registrant previously filed a Registration Statement on Form S-3 (File No.
333-139637) on December 22, 2006 and amended it on January 12, 2007 (the
“Prior Registration Statement”). The Prior Registration Statement originally
registered up to an aggregate dollar amount of $150,000,000 of the Registrant’s
common stock, preferred stock, warrants and/or units consisting of two or more
of any such securities. 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 until the registration statement filed with the Securities
and Exchange Commission is effective. This prospectus is not an offer to sell
these securities and it is not soliciting an offer to buy these securities in
any state where the offer or sale is not permitted.
Subject
to completion, dated January 29, 2010
PROSPECTUS
GENEREX
BIOTECHNOLOGY CORPORATION
$150,000,000
Common Stock
Preferred
Stock
Warrants
Units
We may
offer and sell, from time to time, shares of our common stock, preferred stock,
warrants and/or units consisting of two or more of any such securities on terms
to be determined at the time of sale. The preferred stock may be convertible
into shares of our common stock and the warrants may be exercisable for shares
of our common stock or shares of our preferred stock. We may offer these
securities separately or together in one or more offerings with a maximum
aggregate offering price of $150,000,000.
Specific
terms of the securities being sold as well specific terms of these offerings
will be provided in supplements to this prospectus. You should read this
prospectus and any prospectus supplements, including any information
incorporated herein or therein, carefully before you invest.
The
securities being sold may be sold on a delayed basis or continuous basis
directly by us, through dealers, agents or underwriters designated from time to
time, or through any combination of these methods. If any dealers, agents or
underwriters are involved in the sale of the securities in respect of which this
prospectus is being delivered, we will disclose their names and the nature of
our arrangements with them in any prospectus supplement. The net proceeds we
expect to receive from any such sale will also be included in the applicable
prospectus supplement.
Our
common stock is listed on the
NASDAQ Capital Market
under the symbol "GNBT." The last sale price of our common stock on January 28,
2010, as reported by NASDAQ, was $0.59 per share. None of the other securities
offered under this prospectus are publicly traded.
Investing in our common stock
involves risks. See “Risk Factors” beginning on page 3
to read about the factors you should
consider before investing
.
This
prospectus may not be used to offer and sell securities unless accompanied by a
prospectus supplement for the securities being sold.
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 ,
2010
TABLE
OF CONTENTS
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Page
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About
this Prospectus
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1
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Summary
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1
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Risk
Factors
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3
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Cautionary
Note Regarding Forward-Looking Statements
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9
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Use
of Proceeds
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10
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Dilution
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10
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Description
of our Capital Stock
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11
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Description
of Our Warrants
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14
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Description
of Our Units
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16
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Plan
of Distribution
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16
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Legal
Matters
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18
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Experts
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18
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Where
You Can Find More Information
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19
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Incorporation
of Certain Documents by Reference
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19
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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 one or more series
or classes our common stock, preferred stock and/or warrants in one or more
offerings up to an aggregate maximum offering price of $150,000,000 (or its
equivalent in foreign or composite currencies). 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. The prospectus supplement 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 and any applicable prospectus supplement,
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 contained or incorporated by reference in
this prospectus and in any prospectus supplement. We have not authorized anyone
to provide you with different information. We will not make an offer to sell
these securities in any jurisdiction where the offer or sale is not permitted.
The information contained in this prospectus and any prospectus supplement is
accurate only as of the date of this prospectus or such prospectus supplement,
and the information contained in any document incorporated herein or therein by
reference is accurate only as the date of such document incorporated by
reference, regardless of the time of delivery or any sale of our
securities.
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 3, 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 “Generex,” the “Company,” “we,” “us,” and “our”
refer to Generex Biotechnology Corporation.
Our
Company
We are engaged primarily in the research, development and
commercialization of drug delivery systems and technologies. Our primary focus
at the present time is our proprietary technology for the administration of
formulations of large molecule drugs to the oral (buccal) cavity using a
hand-held aerosol applicator.
The
initial product, Generex Oral-lyn™, that we have developed is an oral insulin
formulation for use in the treatment of diabetes. The formulation is sprayed
into the mouth using our RapidMist™ device, a small and lightweight aerosol
applicator that administers a metered dose for absorption. Absorption occurs
through the mucous membranes in the buccal cavity.
To date,
we have received regulatory approval in Ecuador, India, Lebanon and Algeria for
the commercial marketing and sale of Generex Oral-lyn™. We have
initiated Phase III clinical trials for this product and currently have patients
enrolled in clinical sites around the world, including sites in the United
States, Canada, Bulgaria, Poland, Romania, Russia and Ukraine.
Using our
buccal delivery technology, we also have launched a line of over-the-counter
glucose and energy sprays to complement Generex Oral-lyn™. We believe
these products may provide us with an additional revenue stream prior to the
commercialization of Generex Oral-lyn™ in those markets where we have received
regulatory approval.
While we
have also pursued the application of our technology for the buccal delivery of
pharmaceutical products such as morphine, fentanyl citrate and low molecular
weight heparin, our focus has remained on the buccal delivery of
insulin.
In August
2003, we acquired Antigen Express, Inc. Antigen concentrates on
developing proprietary vaccine formulations that work by stimulating the immune
system to either attack offending agents (i.e., cancer cells, bacteria, and
viruses) or to stop attacking benign elements (i.e., self proteins and
allergens). Our immunomedicine product candidates are based on two platform
technologies and are in the research, pre-clinical and clinical stages of
development.
We are a
development stage company. From inception through the end of the fiscal quarter
ended October 31, 2009, we have received only limited revenues from operations.
In the fiscal years ended July 31, 2009 and 2008, we received approximately
$1,118,509 and $124,891 in revenue. The revenue in fiscal 2009 included $550,000
relating to an upfront license fee for the signing of a license and distribution
agreement for Generex Oral-lyn™, while the remainder of the revenue in both
fiscal periods pertained to the sale of our confectionary products. These
numbers do not reflect deferred sales to customers during the respective periods
with the right of return.
We
operate in only one segment: the research, development and commercialization of
drug delivery systems and technologies for metabolic and immunological
diseases.
We were
incorporated in the State of Delaware in 1997. Our principal offices
are located at 33 Harbour Square, Suite 202, Toronto, Ontario, Canada M5J 2G2.
Our telephone number is (416) 364-2551 and our Internet address is
www.generex.com
.
Information contained in, or accessible through, our website does not constitute
a part of this prospectus. 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.
The
Securities We May Offer
The
descriptions of the securities contained in this prospectus, together with the
applicable prospectus supplements, summarize all the material terms and
provisions of the various types of securities that we may offer. We
will describe in the applicable prospectus supplement relating to any securities
the particular terms of the securities offered by that prospectus supplement. If
we indicate in the applicable prospectus supplement, the terms of the securities
may differ from the terms we have summarized below.
We may
sell from time to time, in one or more offerings:
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preferred
stock which may be convertible into shares of our common
stock;
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warrants
to purchase any of the securities listed above;
or
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units
consisting of two or more of any such securities on terms to be determined
at the time of sale.
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In this
prospectus, we refer to the common stock, preferred stock, warrants and units
collectively as "securities." The total dollar amount of all securities that we
may sell will not exceed $150,000,000.
This
prospectus may not be used to consummate a sale of securities unless it is
accompanied by a prospectus supplement.
RISK
FACTORS
An
investment in our stock is very speculative and involves a high degree of risk.
You should carefully consider the following important factors, as well as the
other information in this prospectus, any accompanying prospectus supplement and
the other reports that we have filed heretofore (and will file hereafter) with
the SEC, before purchasing our stock. The risks described below are not the only
ones we face. Additional risks not presently known to us or that we currently
believe are immaterial may also impair our business operations and financial
results. If any of the following risks actually occurs, our business, financial
condition or results of operations could be adversely affected. In such case,
the trading price of our common stock could decline and you could lose all or
part of your investment. Our actual results could differ materially from those
anticipated in these forward-looking statements as a result of certain factors,
including the risks we face described below.
Risks
Related to Our Financial Condition
We
have a history of losses and will incur additional losses.
We are a
development stage company with a limited history of operations, and do not
expect sufficient revenues to support our operation in the immediately
foreseeable future. In the three months ended October 31, 2009,
we received revenues of $97,542 from sales of our over-the-counter confectionary
products. In the fiscal year ended July 31, 2009, we received modest
revenues of approximately $618,509 from sales of these products. We
did not recognize any revenue from the sale of our oral insulin product in
Ecuador or India in fiscal 2009, although we did recognize $500,000 in licensing
fee revenue relating to the signing of a licensing and distribution agreement
for the sale of Generex Oral-lyn™ in Korea. We do not expect to receive any
revenues in Ecuador until we enter into a definitive manufacturing and
distribution agreement with our business partner there. While we have entered
into a licensing and distribution agreement with a leading Indian-based
pharmaceutical company and insulin distributor, we do not anticipate significant
revenue from the initial commercial launch of Generex Oral-lyn™ in India
sometime this fiscal year. We also have entered in subdistribution
agreements in Lebanon and Algeria but did not receive any revenue from the
launch of the product in those countries in calendar year 2009.
To date,
we have not been profitable and our accumulated net loss available to
shareholders was $302,180,145 at October 31, 2009. Our losses have resulted
principally from costs incurred in research and development, including clinical
trials, and from general and administrative costs associated with our
operations. While we seek to attain profitability, we cannot be sure that we
will ever achieve product and other revenue sufficient for us to attain this
objective.
With the
exception of Generex Oral-lyn™ which is currently available for sale in Ecuador
and has been approved for sale in India, Lebanon and Algeria and our
over-the-counter glucose and energy spray products, Glucose RapidSpray™,
BaBOOM!™ Energy Spray and Crave-Nx™, our product candidates are in research or
early stages of pre-clinical and clinical development. We will need to conduct
substantial additional research, development and clinical trials. We will also
need to receive necessary regulatory clearances both in the United States and
foreign countries and obtain meaningful patent protection for and establish
freedom to commercialize each of our product candidates. We must also complete
further clinical trials and seek regulatory approvals for Generex Oral-lyn™ in
countries outside of Ecuador, India, Lebanon and Algeria. We cannot be sure that
we will obtain required regulatory approvals, or successfully research, develop,
commercialize, manufacture and market any other product candidates. We expect
that these activities, together with future general and administrative
activities, will result in significant expenses for the foreseeable
future.
We
will need additional capital.
To
progress in product development or marketing, we will need additional capital
which may not be available to us. This may delay our progress in product
development or market.
We will
require funds in excess of our existing cash resources:
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To
proceed with the development of our buccal insulin
product;
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To
finance the research and development of new products based on our buccal
delivery and immunomedicine technologies, including clinical testing
relating to new products;
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To
finance the research and development activities of our subsidiary Antigen
with respect to other potential
technologies;
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To
commercially launch and market developed
products;
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To
develop or acquire other technologies or other lines of
business;
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To
establish and expand our manufacturing
capabilities;
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To
finance general and administrative activities that are not related to
specific products under development;
and
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To
otherwise carry on business.
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In the
past, we have funded most of our development and other costs through equity
financing. We anticipate that our existing capital resources will enable us to
maintain currently planned operations through the next twelve months. However,
this expectation is based on our current operating plan, which could change as a
result of many factors, and we may need additional funding sooner than
anticipated. Because our operating and capital resources are insufficient to
meet future requirements, we will have to raise additional funds in the near
future to continue the development and commercialization of our products.
Unforeseen problems, including materially negative developments in our clinical
trials or in general economic conditions, could interfere with our ability to
raise additional equity capital or materially adversely affect the terms upon
which such funding is available.
It is
possible that we will be unable to obtain additional funding as and when we need
it. If we were unable to obtain additional funding as and when needed, we could
be forced to delay the progress of certain development efforts. Such a scenario
poses risks. For example, our ability to bring a product to market and obtain
revenues could be delayed, our competitors could develop products ahead of us,
and/or we could be forced to relinquish rights to technologies, products or
potential products.
Our
research and development and marketing efforts may be highly dependent on
corporate collaborators and other third parties who may not devote sufficient
time, resources and attention to our programs, which may limit our efforts to
successfully develop and market potential products.
Because
we have limited resources, we have sought to enter into collaboration agreements
with other pharmaceutical companies that will assist us in developing, testing,
obtaining governmental approval for and commercializing products using our
buccal delivery and immunomedicine technologies. Any collaborator with whom we
may enter into such collaboration agreements may not support fully our research
and commercial interests since our program may compete for time, attention and
resources with such collaborator's internal programs. Therefore, these
collaborators may not commit sufficient resources to our program to move it
forward effectively, or that the program will advance as rapidly as it might if
we had retained complete control of all research, development, regulatory and
commercialization decisions.
Risks
Related to Our Technologies
With
the exception of Generex Oral-lyn™, Glucose RapidSpray™, BaBOOM! ™ Energy Spray
and Crave-Nx™, our technologies and products are at an early stage of
development and we cannot expect significant revenues in respect thereof in the
foreseeable future.
We have
no products approved for commercial sale at the present time with the exception
of Generex Oral-lyn™ in Ecuador, Lebanon, Algeria and India and our glucose
sprays which are available over-the-counter in certain retail outlets in the
United States and Canada and in the Middle East. To be profitable, we must not
only successfully research, develop and obtain regulatory approval for our
products under development, but also manufacture, introduce, market and
distribute them once development is completed. We have yet to manufacture,
market and distribute these products on a large-scale commercial basis, and we
expect to receive only modest revenues from product sales in fiscal year 2010.
We may not be successful in one or more of these stages of the development or
commercialization of our products, and/or any of the products we develop may not
be commercially viable. Until we can establish that they are commercially viable
products, we will not receive significant revenues from ongoing
operations.
Until
we receive regulatory approval to sell our pharmaceutical products in additional
countries, our ability to generate revenues from operations may be limited and
those revenues may be insufficient to sustain operations. Many factors impact
our ability to obtain approvals for commercially viable products.
Our only
pharmaceutical product that has been approved for commercial sale by drug
regulatory authorities is our oral insulin spray formulation, and that approval
was obtained in Ecuador, Lebanon, Algeria and India. We have begun the
regulatory approval process for our oral insulin, buccal morphine and fentanyl
products in other countries, and we have initiated late stage clinical trials of
Generex Oral-lyn™ at some of our clinical trial sites in North America according
to the Phase III clinical plan.
Our
immunomedicine products are in the pre-clinical stage of development, with the
exception of a Phase II trial in human patients with stage II HER-2/neu positive
breast cancer (U.S.), a Phase I trial in human patients with prostate cancer
(Athens, Greece), a Phase I trial in human patients with breast or ovarian
cancer (U.S.) and a Phase I trial in human volunteers of a peptide vaccine for
use against the H5N1 avian influenza virus (Beirut, Lebanon).
Pre-clinical
and clinical trials of our products, and the manufacturing and marketing of our
technologies, are subject to extensive, costly and rigorous regulation by
governmental authorities in the United States, Canada and other countries. The
process of obtaining required regulatory approvals from the FDA and other
regulatory authorities often takes many years, is expensive and can vary
significantly based on the type, complexity and novelty of the product
candidates. For these reasons, it is possible we will not receive regulatory
approval for any prescription pharmaceutical product candidate in any countries
other than Ecuador, Lebanon, Algeria and India.
In
addition, we cannot be sure when or if we will be permitted by regulatory
agencies to undertake additional clinical trials or to commence any particular
phase of clinical trials. Because of this, statements in this Annual Report
regarding the expected timing of clinical trials cannot be regarded as actual
predictions of when we will obtain regulatory approval for any "phase" of
clinical trials.
Delays in
obtaining United States or other foreign approvals for our pharmaceutical
products could result in substantial additional costs to us, and, therefore,
could adversely affect our ability to compete with other companies. If
regulatory approval is ultimately granted in any countries other than Ecuador,
Lebanon, Algeria and India, the approval may place limitations on the intended
use of the product we wish to commercialize, and may restrict the way in which
we are permitted to market the product.
Due
to legal and factual uncertainties regarding the scope and protection afforded
by patents and other proprietary rights, we may not have meaningful protection
from competition.
Our
long-term success will substantially depend upon our ability to protect our
proprietary technologies from infringement, misappropriation, discovery and
duplication and avoid infringing the proprietary rights of others. Our patent
rights and the patent rights of biotechnology and pharmaceutical companies in
general, are highly uncertain and include complex legal and factual issues.
Because of this, our pending patent applications may not be granted. These
uncertainties also mean that any patents that we own or will obtain in the
future could be subject to challenge, and even if not challenged, may not
provide us with meaningful protection from competition. Due to our financial
uncertainties, we may not possess the financial resources necessary to enforce
our patents. Patents already issued to us or our pending applications may become
subject to dispute, and any dispute could be resolved against
us.
Because a
substantial number of patents have been issued in the field of alternative drug
delivery and because patent positions can be highly uncertain and frequently
involve complex legal and factual questions, the breadth of claims obtained in
any application or the enforceability of our patents cannot be predicted.
Consequently, we do not know whether any of our pending or future patent
applications will result in the issuance of patents or, to the extent patents
have been issued or will be issued, whether these patents will be subject to
further proceedings limiting their scope, will provide significant proprietary
protection or competitive advantage, or will be circumvented or
invalidated.
Also
because of these legal and factual uncertainties, and because pending patent
applications are held in secrecy for varying periods in the United States and
other countries, even after reasonable investigation we may not know with
certainty whether any products that we (or a licensee) may develop will infringe
upon any patent or other intellectual property right of a third party. For
example, we are aware of certain patents owned by third parties that such
parties could attempt to use in the future in efforts to affect our freedom to
practice some of the patents that we own or have applied for. Based upon the
science and scope of these third-party patents, we believe that the patents that
we own or have applied for do not infringe any such third-party patents;
however, we cannot know for certain whether we could successfully defend our
position, if challenged. We may incur substantial costs if we are required to
defend our intellectual property in patent suits brought by third parties. These
legal actions could seek damages and seek to enjoin testing, manufacturing and
marketing of the accused product or process. In addition to potential liability
for significant damages, we could be required to obtain a license to continue to
manufacture or market the accused product or process.
Risks
Related to Marketing of Our Potential Products
We
may not become, or stay, profitable even if our pharmaceutical products are
approved for sale.
Even if
we obtain regulatory approval to market our oral insulin product outside of
Ecuador, India, Lebanon and Algeria or to market any other prescription
pharmaceutical product candidate, many factors may prevent the product from ever
being sold in commercial quantities. Some of these factors are beyond our
control, such as:
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acceptance
of the formulation or treatment by health care professionals and diabetic
patients;
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the
availability, effectiveness and relative cost of alternative diabetes or
immunomedicine treatments that may be developed by competitors;
and
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the
availability of third-party (i.e., insurer and governmental agency)
reimbursements.
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We will
not receive significant revenues from Generex Oral-lyn™ or any of our other
pharmaceuticals products that may receive regulatory approval until we can
successfully manufacture, market and distribute them in the relevant
markets.
Similarly,
the successful commercialization of our over-the-counter glucose spray products
may be hindered by manufacturing, marketing and distribution
limitations.
We have
to depend upon others for marketing and distribution of our products, and we may
be forced to enter into contracts limiting the benefits we may receive and the
control we have over our products. We intend to rely on collaborative
arrangements with one or more other companies that possess strong marketing and
distribution resources to perform these functions for us. We may not be able to
enter into beneficial contracts, and we may be forced to enter into contracts
for the marketing and distribution of our products that substantially limit the
potential benefits to us from commercializing these products. In addition, we
will not have the same control over marketing and distribution that we would
have if we conducted these functions ourselves.
We
may not be able to compete with treatments now being marketed and developed, or
which may be developed and marketed in the future by other
companies.
Our
products will compete with existing and new therapies and treatments. We are
aware of a number of companies currently seeking to develop alternative means of
delivering insulin, as well as new drugs intended to replace insulin therapy at
least in part. We are also aware of a number of companies currently seeking to
develop alternative means of enhancing and suppressing peptides. In the longer
term, we also face competition from companies that seek to develop cures for
diabetes and other malignant, infectious, autoimmune and allergic diseases
through techniques for correcting the genetic deficiencies that underlie such
diseases.
Numerous
pharmaceutical, biotechnology and drug delivery companies, hospitals, research
organizations, individual scientists and nonprofit organizations are engaged in
the development of alternatives to our technologies. Some of these companies
have greater research and development capabilities, experience, manufacturing,
marketing, financial and managerial resources than we do. Collaborations or
mergers between large pharmaceutical or biotechnology companies with competing
drug delivery technologies could enhance our competitors’ financial, marketing
and other resources. Developments by other drug delivery companies could make
our products or technologies uncompetitive or obsolete. Accordingly, our
competitors may succeed in developing competing technologies, obtaining FDA
approval for products or gaining market acceptance more rapidly than we
can.
Some of
our most significant competitors, Pfizer, Eli Lilly, and Novo Nordisk, have
announced that they will discontinue development and/or sale of their inhalable
forms of insulin. Unlike inhaled insulin formulations, Generex Oral-lyn™ is a
buccally absorbed formulation with no residual pulmonary deposition. We believe
that our buccal delivery technology offers several advantages over inhaled
insulin, including the avoidance of pulmonary inhalation, which requires
frequent physician monitoring, ease of use and portability.
If
government programs and insurance companies do not agree to pay for or reimburse
patients for our pharmaceutical products, our success will be
impacted.
Sales of
our oral insulin formulation in Ecuador, Lebanon, Algeria and India and our
other potential pharmaceutical products in other markets will depend in part on
the availability of reimbursement by third-party payers such as government
health administration authorities, private health insurers and other
organizations. Third-party payers often challenge the price and
cost-effectiveness of medical products and services. Governmental approval of
health care products does not guarantee that these third-party payers will pay
for the products. Even if third-party payers do accept our product, the amounts
they pay may not be adequate to enable us to realize a profit. Legislation and
regulations affecting the pricing of pharmaceuticals may change before our
products are approved for marketing and any such changes could further limit
reimbursement.
Risks
Related to Potential Liabilities
We
face significant product liability risks, which may have a negative effect on
our financial condition.
The
administration of drugs or treatments to humans, whether in clinical trials or
commercially, can result in product liability claims whether or not the drugs or
treatments are actually at fault for causing an injury. Furthermore, our
pharmaceutical products may cause, or may appear to have caused, serious adverse
side effects (including death) or potentially dangerous drug interactions that
we may not learn about or understand fully until the drug or treatment has been
administered to patients for some time. Product liability claims can be
expensive to defend and may result in large judgments or settlements against us,
which could have a severe negative effect on our financial condition. We
maintain product liability insurance in amounts we believe to be commercially
reasonable for our current level of activity and exposure, but claims could
exceed our coverage limits. Furthermore, due to factors in the insurance market
generally and our own experience, we may not always be able to purchase
sufficient insurance at an affordable price. Even if a product liability claim
is not successful, the adverse publicity and time and expense of defending such
a claim may interfere with our business.
Risks
Related to the Market for Our Common Stock
Our
common stock could be delisted from The NASDAQ Capital Market.
On July
23, 2008, we received notice from The NASDAQ Stock Market that we were not
compliance with Marketplace Rule 4310(c)(4) (now known as Listing Rule
5550(a)(2)), which requires us to have a minimum bid price per share of at least
$1.00 for thirty (30) consecutive business days. In accordance with
this Rule, we had 180 calendar days, or until January 20, 2009, subject to
extension, to regain compliance with this Rule.
Our
initial compliance period of 180 calendar days ending on January 20, 2009 was
subsequently extended until November 9, 2009 due to NASDAQ’s temporary
suspension of the minimum bid price requirement from October 16, 2008 until
August 3, 2009.
On
November 9, 2009, we received a letter from NASDAQ indicating that we had not
regained compliance with the $1.00 minimum bid price required for continued
listing under Listing Rule 5550(a)(2) within the grace period previously allowed
by NASDAQ following the initial notice of noncompliance on
July 23, 2008.
Pursuant
to Listing Rule 5810(c)(3)(A), NASDAQ has given us an additional 180 calendar
day compliance period because we met all other initial inclusion criteria (other
than the minimum bid price requirement) as of January 6,
2009. Therefore, we have 180 calendar days, or until
May 5, 2010, to regain compliance with the rule. To regain compliance
with the minimum bid price requirement, the closing bid price of our common
stock must close at $1.00 per share or more for a minimum of ten consecutive
business days.
If, by
May 5, 2010, we do not regain compliance with Listing Rule 5550(a)(2), we will
receive written notification that our stock will be delisted. At that
time, we may appeal the delisting determination to a NASDAQ Hearings
Panel. An appeal to the Hearings Panel would stay the delisting. . If
we are not successful in such an appeal, our stock would be delisted from the
NASDAQ Capital Market and likely trade on NASDAQ’s over-the-counter bulletin
board, assuming we meet the requisite criteria.
The
price of our common stock may be volatile.
There may
be wide fluctuations in the price of our common stock. These fluctuations may be
caused by several factors including:
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announcements
of research activities and technology innovations or new products by us or
our competitors;
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changes
in market valuation of companies in our industry
generally;
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variations
in operating results;
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changes
in governmental regulations;
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developments
in patent and other proprietary
rights;
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public
concern as to the safety of drugs or treatments developed by us or
others;
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results
of clinical trials of our products or our competitors' products;
and
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regulatory
action or inaction on our products or our competitors'
products.
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From time
to time, we may hire companies to assist us in pursuing investor relations
strategies to generate increased volumes of investment in our common stock. Such
activities may result, among other things, in causing the price of our common
stock to increase on a short-term basis.
Furthermore,
the stock market generally and the market for stocks of companies with lower
market capitalizations and small biopharmaceutical companies, like us, have from
time to time experienced, and likely will again experience significant price and
volume fluctuations that are unrelated to the operating performance of a
particular company. During the third calendar quarter of 2008 and
continuing to date, we, like many other publicly traded companies, have
experienced a sharp decline in the price of our stock attributable to concerns
about the current global recession. The widespread decline in stock
prices led The NASDAQ Stock Market to further extend its temporary suspension of
enforcement of the minimum bid price requirement until
July 31, 2009.
Provisions
of our Restated Certificate of Incorporation could delay or prevent the
acquisition or sale of our business.
Our
Restated Certificate of Incorporation permits our Board of Directors to
designate new series of preferred stock and issue those shares without any vote
or action by our stockholders. Such newly authorized and issued shares of
preferred stock could contain terms that grant special voting rights to the
holders of such shares that make it more difficult to obtain stockholder
approval for an acquisition of our business or increase the cost of any such
acquisition.
Our
recent equity financing will dilute current stockholders and could prevent the
acquisition or sale of our business.
The
equity financing transactions into which we have recently entered have and will
dilute current stockholders. Currently approximately 42,680,284 shares of common
stock are issuable upon exercise of the warrants that we issued on March 31,
2008, May 15, 2009, June 15, 2009, August 6, 2009 and September 14, 2009
(without regard to additional shares which may become issuable due to
anti-dilution adjustments or in connection with payments of interest), which
represents approximately 17% of the shares of common stock currently
outstanding. Assuming the holders of the warrants convert and
exercise all of the warrants into shares of common stock, the number of shares
of issued and outstanding common stock will increase significantly, and current
stockholders will own a smaller percentage of the outstanding common stock of
Generex. The issuance of shares of common stock pursuant to the warrants will
also have a dilutive effect on earnings per share and may adversely affect the
market price of the common stock.
In
addition, the issuance of shares of common stock upon exercise of the warrants
sold in the offerings that closed on June 15, 2009, August 6, 2009 and September
14, 2009 and sold in our March 31, 2008 private placement could have an
anti-takeover effect because such issuance will make it more difficult for, or
discourage an attempt by, a party to obtain control of Generex by tender offer
or other means. The issuance of common stock upon the exercise of the warrants
will increase the number of shares entitled to vote, increase the number of
votes required to approve a change of control of the company, and dilute the
interest of a party attempting to obtain control of the company.
If we
raise funds through one or more additional equity financings in the future,
including if we exercise our right to issue and sell shares under the sales
agreement with Wm Smith, it will have a further dilutive effect on existing
holders of our shares by reducing their percentage ownership. The shares may be
sold at a time when the market price is low because we need the funds. This will
dilute existing holders more than if our stock price was higher. In addition,
equity financings normally involve shares sold at a discount to the current
market price.
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
We have
made statements in this prospectus that may constitute "forward-looking
statements" within the meaning of the Private Securities Litigation Reform Act
of 1995 (the "Act"). The Act limits our liability in any lawsuit based on
forward-looking statements that we have made. All statements, other than
statements of historical facts, included in this prospectus that address
activities, events or developments that we expect or anticipate will or may
occur in the future, including such matters as our projections, future capital
expenditures, business strategy, competitive strengths, goals, expansion, market
and industry developments and the growth of our businesses and operations, are
forward-looking statements. These statements can be identified by introductory
words such as "expects," “anticipates,” "plans," "intends," "believes," "will,"
"estimates," "projects" or words of similar meaning, and by the fact that they
do not relate strictly to historical or current facts. Our forward-looking
statements address, among other things:
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our
expectations concerning product candidates for our
technologies;
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our
expectations concerning existing or potential development and license
agreements for third-party collaborations and joint
ventures;
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our
expectations of when different phases of clinical activity may commence
and conclude;
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our
expectations of when regulatory submissions may be filed or when
regulatory approvals may be received;
and
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our
expectations of when commercial sales of our products may commence and
when actual revenue from the product sales may be
received.
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Any or
all of our forward-looking statements may turn out to be wrong. They may be
affected by inaccurate assumptions that we might make or by known or unknown
risks and uncertainties. Actual outcomes and results may differ materially from
what is expressed or implied in our forward-looking statements. Among the
factors that could affect future results are:
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the
inherent uncertainties of product development based on our new and as yet
not fully proven technologies;
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the
risks and uncertainties regarding the actual effect on humans of seemingly
safe and efficacious formulations and treatments when tested
clinically;
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the
inherent uncertainties associated with clinical trials of product
candidates;
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the
inherent uncertainties associated with the process of obtaining regulatory
approval to market product
candidates;
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the
inherent uncertainties associated with commercialization of products that
have received regulatory approval;
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the
volatility of, and recent decline in, our stock price and the impact on
our ability to pay installments due on our outstanding senior secured
notes in stock rather than cash;
and
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our
ability to obtain the necessary financing to fund our
operations.
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Additional
factors that could affect future results are set forth above under the caption
“Risk Factors.” We caution investors that the forward-looking
statements contained in this prospectus must be interpreted and understood in
light of conditions and circumstances that exist as of the date of this
prospectus. We expressly disclaim any obligation or undertaking to update or
revise forward-looking statements to reflect any changes in management's
expectations resulting from future events or changes in the conditions or
circumstances upon which such expectations are based. You are
advised, however, to consult any further disclosures we make on related subjects
in our 10-K, 10-Q and 8-K reports to the SEC.
USE
OF PROCEEDS
Except as
described in any prospectus supplement, we currently intend to use the net
proceeds from this offering for general corporate purposes, including to
continue the clinical trials of, and commercialization and manufacturing of, our
oral insulin formulation, in the research and development of other products, and
for general and administrative expenses. We may also issue the securities
offered under this prospectus in connection with product license and supply
agreements, research collaboration agreements and to our commercial vendors and
suppliers in exchange for products and services.
Each time
we issue securities, we will provide a prospectus supplement that will contain
information about how we intend to use the proceeds from each such
offering.
Until we
use the net proceeds of this offering for the above purposes, we intend to
invest the funds in short-term, investment grade, interest-bearing securities.
We cannot predict whether the proceeds invested will yield a favorable return.
We have not yet determined the amount or timing of the expenditures for the
categories listed above, and these expenditures may vary significantly depending
on a variety of factors. As a result, we will retain broad discretion over the
use of the net proceeds from this offering.
We cannot
guarantee that we will receive any proceeds in connection with any offering
hereunder because we may choose not to issue any of the securities covered by
this prospectus.
DILUTION
We will
set forth in a prospectus supplement the following information regarding any
material dilution of the equity interests of investors purchasing securities in
an offering under this
prospectus
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the
net tangible book value per share of our equity securities before and
after the offering;
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the
amount of the increase in such net tangible book value per share
attributable to the cash payments made by purchasers in the offering;
and
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the
amount of the immediate dilution from the public offering price which will
be absorbed by such purchasers.
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DESCRIPTION
OF OUR CAPITAL STOCK
Set forth
below is a summary of the material terms of our capital stock. This summary is
not complete. We encourage you to read our Restated Certificate of Incorporation
and our Amended and Restated By-Laws that we have previously filed with the SEC.
See “Where You Can Find More Information.”
General
Our
authorized capital stock consists of: (i) 750,000,000 shares of common stock,
par value $.001 per share, of which 249,702,601 shares were outstanding as of
January 28, 2010, and (ii) 1,000,000 shares of undesignated preferred stock, par
value $.001 per share.
Common
Stock
Holders
of common stock are entitled to one vote for each share owned as of record on
all matters on which shareholders may vote. Holders of common stock
do not have cumulative voting rights in the election of
directors. Therefore, the holders of more than 50% of the outstanding
shares can elect the entire Board of Directors. The holders of common
stock are entitled, upon liquidation or dissolution of the company, to receive
pro rata all remaining assets available for distribution to stockholders after
payment to any preferred shareholders who may have preferential
rights. The common stock has no preemptive or other subscription
rights, and there are no conversion rights or redemption provisions. All
outstanding shares of common stock are validly issued, fully paid, and
nonassessable.
Undesignated
Preferred Stock
Our Board
of Directors has the authority to issue up to 1,000,000 shares of preferred
stock in one or more series and fix the number of shares constituting any such
series, the voting powers, designations, preferences and relative,
participating, optional or other special rights and qualifications, limitations
or restrictions thereof, including the dividend rights, dividend rate, terms of
redemption (including sinking fund provisions), redemption price or prices,
conversion rights and liquidation preferences of the shares constituting any
series, without any further vote or action by the stockholders. For example, the
Board of Directors is authorized to issue a series of preferred stock that would
have the right to vote, separately or with any other series of preferred stock,
on any proposed amendment to our Restated Certificate of Incorporation or on any
other proposed corporate action, including business combinations and other
transactions.
The terms
of any particular series of preferred stock will be described in the prospectus
supplement relating to the offering of shares of that particular series of
preferred and may include, among other things:
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the
title and stated value;
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the
number of shares authorized;
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the
liquidation preference per share;
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the
dividend rate, period and payment date,
and
method of
calculation (including whether cumulative or
non-cumulative);
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terms
and amount of any sinking fund;
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provisions
for redemption or repurchase, if applicable, and
any
restrictions on the ability of the company to exercise such redemption and
repurchase rights;
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conversion
rights and rates, if applicable, including the conversion price and how
and when it will be calculated and
adjusted;
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Preemptive
rights, if any;
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Restrictions
on sale, transfer and assignment, if
any;
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the
relative ranking and preferences of the preferred stock;
and
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any
other specific terms, rights or limitations of, or restrictions on, such
preferred stock.
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Anti-Takeover
Provisions
We are
not aware of any pending takeover attempt or interest in making such an attempt.
Our Restated Certificate of Incorporation and Amended and Restated Bylaws
contain certain provisions which may be deemed to be "anti-takeover" in that
they may deter, discourage or make more difficult the assumption of control of
Generex by another corporation or person through a tender offer, merger, proxy
contest or similar transaction or series of transactions.
Authorized but Unissued
Shares:
The authorized but unissued shares of our common stock and
preferred stock are available for future issuance without stockholder approval,
subject to any limitations imposed by the NASDAQ Stock Market. The Board of
Directors may set the rights, preferences and terms of new preferred stock,
without shareholder approval. Shares of preferred stock could be issued quickly
without shareholder approval, with terms calculated to delay or prevent a change
in control of Generex. Our stockholders do not have preemptive rights with
respect to the purchase of these shares. Therefore, such issuance could result
in a dilution of voting rights and book value per share of the common stock. No
shares of preferred stock are currently outstanding, and we have no present plan
to issue any preferred stock.
Advance Notice Requirements for
Stockholder Proposals and Director Nominations:
Our Amended and Restated
Bylaws provide that a stockholder seeking to bring business before an annual
meeting of stockholders, or to nominate candidates for election as directors,
must provide timely notice of such stockholder’s intention in writing. To be
timely, a stockholder’s notice must be received not less than 60 days nor more
than 90 days prior to the meeting at which such proposal or candidate is to be
considered. However, if we do not give prior notice or make public disclosure of
the date of the meeting at least 70 days prior to the meeting date, notice by
the stockholder is considered timely if it is received no later than the close
of business on the 10th day following the day on which such notice was mailed or
public disclosure was made. If a stockholder desires to have a proposal included
in Generex’s proxy statement, notice of such proposal must be received not less
than 120 days prior to the first anniversary of the date of Generex’s notice of
the previous year’s annual meeting. These advance notice provisions may preclude
stockholders from bringing matters before a meeting or from making nominations
for directors.
Special Meetings of
Stockholders:
Our Amended and Restated Bylaws provide that special
meetings of stockholders may be called only by the Board of Directors, the
Chairman of the Board or the President, and may be called by the Board upon the
request of the holders of a majority of the outstanding shares of stock of the
company entitled to vote at the meeting. Further, business transacted at any
special meeting of stockholders is limited to matters relating to the purpose or
purposes stated in the notice of meeting.
General Effect of Anti-Takeover
Provisions:
The overall effect of these provisions may be to deter a
future tender offer or other takeover attempt that some stockholders might view
to be in their best interests at that time. In addition, these provisions may
have the effect of assisting our current management in retaining its position
and place it in a better position to resist changes which some stockholders may
want to make if dissatisfied with the conduct of our business.
Stockholder
Rights Plan
At our
annual meeting on May 30, 2006, our stockholders approved the adoption of a
stockholder rights plan that will allow our Board of Directors to declare a
dividend of one share purchase right for each outstanding share of our common
stock. Our Board of Directors has considered adoption of this plan but has not
yet approved its adoption. We expect that any stockholder rights plan adopted by
our Board will contain terms substantially as described below:
The terms
of the rights plan will provide for a dividend distribution of one preferred
share purchase right, which we refer to as a “Right,” for each outstanding share
of our common stock. The dividend will be payable on a date established by the
Board to the stockholders of record on that date. Each Right will entitle the
registered holder to purchase from Generex one one-hundredth of a share of
preferred stock (each a “Preferred Share” and, collectively, the “Preferred
Shares”) at a price of $.01 per one one-hundredth of a share of preferred stock,
subject to certain adjustments. Each Preferred Share will have designations and
powers, preferences and rights, and the qualifications, limitations and
restrictions which make its value approximately equal to the value of one share
of our common stock.
The
Rights will not be exercisable until the earlier to occur of:
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the
date of a public announcement that a person, entity or group of affiliated
or associated persons have acquired beneficial ownership of 20% or more of
our outstanding shares of common stock, which we refer to as an "Acquiring
Person", or
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(ii)
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10
business days (or such later date as may be determined by action of the
Board of Directors prior to such time as any person or entity becomes an
Acquiring Person) following the commencement of, or announcement of an
intention to commence, a tender offer or exchange offer the consummation
of which would result in any person or entity becoming an Acquiring Person
(the earlier of such dates being called the "Distribution
Date").
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Until the
Distribution Date, the Rights will be transferable with and only with shares of
our common stock. The Rights will expire ten years after adoption of the
stockholders rights plan unless the Rights are earlier redeemed or exchanged by
Generex.
Preferred
Shares purchasable upon exercise of the Rights will not be redeemable. Each
Preferred Share will be entitled to a minimum preferential quarterly dividend
payment of $1.00 but will be entitled to an aggregate dividend of 100 times the
dividend declared per share of common stock. In the event of liquidation, the
holders of the Preferred Shares would be entitled to a minimum preferential
liquidation payment of $100 per share, but would be entitled to receive an
aggregate payment equal to 100 times the payment made per share of common stock.
Each Preferred Share will have 100 votes, voting together with the common stock.
Finally, in the event of any merger, consolidation or other transaction in which
shares of common stock are exchanged, each Preferred Share will be entitled to
receive 100 times the amount of consideration received per share of common
stock. These rights will be protected by customary anti-dilution provisions.
Because of the nature of the Preferred Shares' dividend and liquidation rights,
the value of one one-hundredth of a Preferred Share should approximate the value
of one share of common stock. The Preferred Shares would rank junior to any
other series of our preferred stock.
In the
event that any person or group of affiliated or associated persons becomes an
Acquiring Person, proper provision will be made so that each holder of a Right,
other than Rights beneficially owned by the Acquiring Person and its associates
and affiliates (which will thereafter be void), will for a 60-day period have
the right to receive upon exercise that number of shares of Preferred Stock
having a market value of two times the exercise price of the Right (or, if such
number of shares is not and cannot be authorized, Generex may issue Preferred
Shares, cash, debt, stock or a combination thereof in exchange for the Rights).
This right will terminate 60 days after the date on which the Rights become
nonredeemable (as described below), unless there is an injunction or similar
obstacle to exercise of the Rights, in which event this right will terminate 60
days after the date on which the Rights again become exercisable.
The
rights plan will contain certain exceptions to the characterization of a person
or group as an "Acquiring Person." That term shall not be deemed to
include:
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a
subsidiary of Generex,
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any
employee benefit or compensation plan of
Generex,
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any
entity holding shares of common stock for or pursuant to the terms of any
such employee benefit or compensation plan
or
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any
officer, director or current 5% holder as of the date the rights plan is
implemented.
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The
rights plan may also except certain institutional shareholders from the
definition of “Acquiring Person.” In addition, except under limited
circumstances, no person or entity shall become an Acquiring Person as the
result of the acquisition of shares of common stock by Generex which, by
reducing the number of shares outstanding, increases the proportionate number of
shares beneficially owned by such person or entity to 20% or more of the shares
of common stock then outstanding.
The
stockholders rights plan may also contain what is commonly known as a
“flip-over” provision. In the event that Generex is acquired in a merger or
other business combination transaction or 50% or more of its consolidated assets
or earning power are sold to an Acquiring Person, its associates or affiliates
or certain other persons in which such persons have an interest, the plan will
require that proper provision be made so that each holder of a Right will
thereafter have the right to receive, upon the exercise thereof at the then
current exercise price of the Right, that number of shares of common stock of
the acquiring company which at the time of such transaction will have a market
value of two times the exercise price of the Right.
At any
time after an Acquiring Person becomes an Acquiring Person and prior to the
acquisition by such Acquiring Person of 50% or more of the outstanding shares of
Generex’s common stock, our Board of Directors may exchange the Rights (other
than Rights owned by such person or group which have become void), in whole or
in part, at an exchange ratio of one share of common stock, or one one-hundredth
of a Preferred Share, per Right (or, at our election, Generex may issue cash,
debt, stock or a combination thereof in exchange for the Rights), subject to
adjustment.
At any
time prior to the earliest of (i) the day of the first public announcement that
a person has become an Acquiring Person or (ii) the final expiration date of the
rights, our Board of Directors may redeem the Rights in whole, but not in part,
at a price of $.001 per Right. Following the expiration of the above periods,
the Rights become nonredeemable. Immediately upon any redemption of the Rights,
the right to exercise the Rights will terminate and the only right of the
holders of Rights will be to receive the redemption price.
The
Rights would have certain anti-takeover effects. The Rights would cause
substantial dilution to a person or group that attempts to acquire Generex on
terms not approved by our Board of Directors. The Rights should not interfere
with any merger or other business combination approved by our Board of Directors
since the Rights could be amended to permit such acquisition or redeemed by us
at $.001 per Right prior to the earliest of (i) the time that a person or group
has acquired beneficial ownership of 20% or more of our shares of common stock
or (ii) the final expiration date of the rights.
Dividend
Policy
Holders
of our common stock are entitled to receive such dividends as the Board of
Directors may from time to time declare. The Board may declare dividends only
when dividends are legally available. Under the Delaware General Corporation
Law, the Board may only declare dividends out of our capital surplus (generally
the amount of its paid-in capital above the par value of the outstanding stock)
or out of net profits for the fiscal year with respect to which the dividends
are paid. We have never paid any dividends on our common stock and do
not anticipate paying dividends in the foreseeable future.
Transfer
Agent
StockTrans,
Inc., 44 West Lancaster Avenue, Ardmore, PA 19003, is the transfer agent and
registrar for our common stock.
Listing
Our
common stock is listed on the NASDAQ Capital Market under the symbol
"GNBT."
DESCRIPTION OF OUR
WARRANTS
This
description summarizes only the terms of any warrants that we may offer under
this prospectus and related warrant agreements and is not complete. You should
refer to the warrant agreement, including the form of the warrant, relating to
the specific warrants being offered for complete terms, which will be described
and included in an accompanying prospectus supplement. Such warrant agreement,
together with the form of the warrant, will be filed with the SEC in connection
with the offering of the specific warrants.
We may
issue warrants for the purchase of common or preferred stock. Warrants may be
issued independently or together with common or preferred stock, and may be
attached to or separate from any offered securities.
We will
issue each series of warrants under a separate warrant agreement. We may enter
into the warrant agreement with a warrant agent and, if so, we will indicate the
name and address of the warrant agent in the applicable prospectus supplement
relating to the particular series of warrants.
The
particular terms of any issue of warrants will be described in the prospectus
supplement relating to the series. Those terms may include:
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the
title of such warrants;
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·
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the
aggregate number of such warrants;
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·
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the
price or prices at which such warrants will be
issued;
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·
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the
currency or currencies (including composite currencies) in which the price
of such warrants may be payable;
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·
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the
terms of the securities issuable upon exercise of such warrants and the
procedures and conditions relating to the exercise of such
warrants;
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·
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the
price at which the securities issuable upon exercise of such warrants may
be acquired;
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·
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the
dates on which the right to exercise such warrants will commence and
expire;
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·
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any
provisions for adjustment of the number or amount of securities receivable
upon exercise of the warrants or the exercise price of the
warrants;
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·
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if
applicable, the minimum or maximum amount of such warrants that may be
exercised at any one time;
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·
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if
applicable, the designation and terms of the securities with which such
warrants are issued and the number of such warrants issued with each such
security or principal amount of such
security;
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·
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if
applicable, the date on and after which such warrants and the related
securities will be separately
transferable;
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if
applicable, the redemption or call provisions of such
warrants;
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information
with respect to book-entry procedures, if any;
and
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any
other terms of such warrants, including terms, procedures and limitations
relating to the exchange or exercise of such
warrants.
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The
prospectus supplement relating to any warrants to purchase equity securities may
also include, if applicable, a discussion of certain U.S. federal income tax and
ERISA considerations.
Exercise of
Warrants
Each
warrant will entitle its holder to purchase the number of shares of common or
preferred stock at the exercise price set forth in, or calculable as set forth
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 expiration date set forth in the applicable
prospectus supplement. After the close of business on the expiration date,
unexercised warrants will become void. We will specify the place or places
where, and the manner in which, warrants may be exercised in the applicable
prospectus supplement. We will set forth on the reverse side of the applicable
certificate (or in the form of exercise notice attached to each warrant) and in
the applicable prospectus supplement the information that the holder of the
warrant will be required to deliver upon exercise.
Upon
receipt of payment and the warrant properly completed and duly executed, we
will, as soon as practicable, forward the purchased securities. If less than all
of the warrants represented by the warrant are exercised, a new warrant will be
issued for the remaining 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, such holder’s
warrants.
Prior to
the exercise of any warrants to purchase preferred stock or common stock,
holders of the warrants will not have any of the rights of holders of the
preferred stock or common stock purchasable upon exercise, including the right
to vote or to receive any payments of dividends.
DESCRIPTION
OF OUR UNITS
We may
issue units comprised of two or more of the other securities described in this
prospectus 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 units will be issued under units agreements, and we may
enter into such unit agreements with a bank or trust company, as unit agent, as
detailed in the prospectus supplement relating to units being
offered.
The
prospectus supplement will describe:
the
designation and terms of the units and of the securities comprising the units,
including whether and under what circumstances the securities comprising the
units may be held or transferred separately;
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A
description of the terms of any unit agreement governing the
units;
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·
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A
description of the provisions for the payment, settlement, transfer or
exchange of the units;
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A
discussion of material U.S. federal income tax considerations, if
applicable; and
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whether
the units will be issued in fully registered or global
form.
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The
descriptions of the units in this prospectus and in any prospectus supplement
are summaries of the material provisions of the applicable agreements. These
descriptions do not restate those agreements in their entirety and may not
contain all the information that you may find useful. We urge you to read the
applicable agreements because they, and not the summaries, define your rights as
holders of the units. For more information, please review the form of the
relevant agreements, which will be filed with the SEC promptly after the
offering of units and will be available as described under the heading “Where
You Can Find Additional Information”.
PLAN
OF DISTRIBUTION
We may
sell any of the securities being offered pursuant to this prospectus from time
to time in one or more of the following ways:
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directly
to purchasers;
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to
or through underwriters;
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through
dealers or agents;
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in
privately negotiated transactions;
or
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through
a combination of methods.
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We may
distribute the securities from time to time in one or more transactions at a
fixed price or prices, which may be changed, at market prices prevailing at the
time of sale, at prices related to the prevailing market prices or at negotiated
prices. We may also determine the price or other terms of the securities offered
under this prospectus by use of an electronic auction.
The
prospectus supplement with respect to the securities being offered will set
forth the terms of the offering, including:
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·
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the
names of the underwriters, dealers or agents, if
any,
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·
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the
terms of the securities being offered, including the purchase price of the
securities and the net proceeds to
us,
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·
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any
underwriting discounts and other items constituting underwriters’
compensation,
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·
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any
over-allotment options under which underwriters may purchase additional
securities from us, and
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·
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any
discounts or concessions allowed or reallowed or paid to dealers and any
securities exchanges on which the securities may be
listed.
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Also, if
applicable, we will describe in the prospectus supplement how any auction will
determine the price or any other terms, how potential investors may participate
in the auction and the nature of the underwriters’ obligations with respect to
the auction.
If
required under applicable state securities laws, we will sell the securities
only through registered or licensed brokers or dealers. In addition, in some
states, we may not sell securities unless they have been registered or qualified
for sale in the applicable state or unless we have complied with an exemption
from any registration or qualification requirements.
If
underwriters are used in an offering, we will sign an underwriting agreement
with the underwriters and will specify the name of each underwriter and the
terms of the transaction (including any underwriting discounts and other terms
constituting compensation of the underwriters and any dealers) in a prospectus
supplement. If an underwriting syndicate is used, the managing
underwriter(s) will be specified on the cover of the prospectus supplement.
If underwriters are used in the sale, the offered securities will be acquired by
the underwriters for their own accounts and may be resold from time to time in
one or more transactions, including negotiated transactions, at a fixed public
offering price or at varying prices determined at the time of sale. Any public
offering price and any discounts or concessions allowed or reallowed or paid to
dealers may be changed from time to time. Unless otherwise set forth in the
prospectus supplement, the obligations of the underwriters to purchase the
offered securities will be subject to conditions precedent, and the underwriters
will be obligated to purchase all of the offered securities if any are
purchased.
If
dealers are used in an offering, we will sell the securities to the dealers as
principals. The dealers then may resell the securities to the public at varying
prices which they determine at the time of resale. The names of the dealers and
the terms of the transaction will be specified in a prospectus
supplement.
The
securities may be sold directly by us or through agents we designate. If agents
are used in an offering, the names of the agents and the terms of the agency
will be specified in a prospectus supplement. Unless otherwise indicated in a
prospectus supplement, the agents will act on a best-efforts basis for the
period of their appointment.
Dealers
and agents named in a prospectus supplement may be deemed to be underwriters
(within the meaning of the Securities Act of 1933, as amended, or the Securities
Act) of the securities described therein.
We may
sell securities directly to one or more purchasers, in which case underwriters
or agents would not be involved in the transaction. In addition, we may sell the
securities directly to institutional investors or others who may be deemed to be
underwriters within the meaning of the Securities Act with respect to any
resales thereof.
Further,
we may authorize agents, underwriters or dealers 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 an applicable prospectus
supplement.
Underwriters,
dealers and agents may be entitled to indemnification by us against specific
civil liabilities, including liabilities under the Securities Act or to
contribution with respect to payments which the underwriters or agents may be
required to make in respect thereof, under underwriting or other agreements.
Certain underwriters, dealers or agents and their associates may engage in
transactions with, and perform services for us in the ordinary course of
business.
Any
underwriter may engage in over-allotment transactions, stabilizing transactions,
short-covering transactions and penalty bids in accordance with
Regulation M under the Exchange Act. Over-allotment 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. We make no representation or prediction as to the
direction or magnitude of any effect that such transactions may have on the
price of the securities. For a description of these activities, see the
information under the heading “Underwriting” in the applicable prospectus
supplement.
Any
common stock sold pursuant to a prospectus supplement will be eligible for
listing and trading on the NASDAQ Capital Market, subject to official notice of
issuance. Any underwriters to whom securities are sold by us for public offering
and sale may make a market in the securities, but the underwriters will not be
obligated to do so and may discontinue any market making at any time without
notice.
As of the
date of this prospectus, we have not entered into any agreements, understandings
or arrangements with any underwriters, broker-dealers or other parties regarding
the sale of securities with the following exception. On October 14,
2009, we entered into an At Market Issuance Sales Agreement with Wm Smith &
Co., under which we may sell an aggregate of $20,000,000 in gross proceeds of
our common stock from time to time through Wm Smith & Co., as the agent for
the offer and sale of the common stock. Wm Smith may sell the common
stock by any method permitted by law, including sales deemed to be an “at the
market” offering as defined in Rule 415 of the Securities Act, including without
limitation sales made directly on NASDAQ Capital Market, on any other existing
trading market for the common stock or to or through a market
maker. Wm Smith may also sell the common stock in privately
negotiated transactions, subject to our prior approval. On October
29, 2009, we announced that in light of general market conditions, we would not
exercise our right to issue and sell shares of our common stock the agreement
with Wm Smith & Co. until further notice. As of the date of this
prospectus, no period of time has been fixed within which the securities will be
offered or sold.
LEGAL
MATTERS
Unless
the applicable prospectus supplement indicates otherwise, the validity of the
issuance of the securities offered in this prospectus will be passed upon for us
by Eckert Seamans Cherin & Mellott, LLC, Two Liberty Place, 50 South 16th
Street, 22nd Floor, Philadelphia, PA 19102. Certain members of the
firm of Eckert Seamans Cherin & Mellott, LLC own additional shares (less
than one percent in total) that they purchased from time to time for cash,
either from us or in the public market.
Any
underwriters will also be advised about legal matters by their own counsel,
which will be named in the prospectus supplement.
EXPERTS
The
consolidated financial statements of Generex Biotechnology Corporation appearing
in Generex Biotechnology Corporation’s Annual Report (Form 10-K) for the
year ended July 31, 2009 have been audited by
MSCM LLP, an independent
registered public accounting firm (successor to Danziger Hochman Partners, LLP),
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.
WHERE
YOU CAN FIND MORE INFORMATION
We file
reports, proxy statements and other documents with the SEC. You may read any
copy any document we file at the SEC’s Public Reference Room at 100 F Street,
N.E., Washington, D.C. 20549. You can obtain information on the operation of the
Public Reference Room by calling the SEC at 1-800-SEC-0330. In addition, the SEC
maintains an Internet site at
www.sec.gov,
from which you
can electronically access our SEC filings.
You
should rely only on the information contained or incorporated by reference in
this prospectus and in any accompanying prospectus supplement. We have not
authorized anyone to provide you with information different from that contained
in this prospectus. The securities offered under this prospectus are offered
only in jurisdictions where offers and sales are permitted. The information
contained in this prospectus is accurate only as of the date of this Prospectus,
regardless of the time of delivery of this Prospectus or any sale of the
securities.
This
prospectus constitutes a part of a Registration Statement we filed with the
Commission under the Securities Act. This prospectus does not contain all of the
information set forth in the Registration Statement, certain parts of which are
omitted in accordance with the rules and regulations of the Commission. For
further information with respect to the company and our securities, reference is
hereby made to the Registration Statement. The Registration Statement may be
inspected at the public reference facilities maintained by the Commission at the
addresses set forth in the preceding paragraph. Statements contained herein
concerning any document filed as an exhibit are not necessarily complete, and,
in each instance, reference is made to the copy of such document filed as an
exhibit to the Registration Statement. Each such statement is qualified in its
entirety by such reference.
INCORPORATION
OF CERTAIN DOCUMENTS BY REFERENCE
The SEC
allows us to “incorporate by reference” the information contained in documents
that we file with them, which means that we can disclose important information
to you by referring you to those documents. The information incorporated by
reference is considered to be part of this prospectus and any prospectus
supplement. 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 this information.
The
following documents (other than current reports or portions thereof furnished
under Item 2.02 or Item 7.01 of Form 8-K) heretofore filed with the SEC by us
under the Securities and Exchange Act of 1934, as amended, are incorporated
herein by reference:
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(a)
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Our Annual Report on Form 10-K
filed with the SEC on October 14, 2009 , for the year ended July 31,
2009;
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(b)
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Our
Quarterly Report on Form 10-Q filed with the SEC on December 11, 2009, for
the quarter ended October 31, 2009;
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(c)
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The portions of our Definitive
Proxy Statement on Schedule 14A that are deemed “filed” with the SEC under
the Securities Exchange Act of 1934, as amended, filed on June 18,
2009;
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(d)
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Our Current Reports on Form 8-K
filed with the SEC on August 6, 2009, September 15, 2009, October 1, 2009,
October 14, 2009, October 15, 2009, October 20, 2009, October 23, 2009,
October 30, 2009, November 11, 2009 and December 19, 2009;
and
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(e)
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The
description of our common stock contained in our Form 10 filed with the
SEC on December 14, 1998, as amended by a Form 10/A filed with the SEC on
February 24, 1999, and including any amendment or report subsequently
filed for the purpose of updating the
description.
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All
documents (other than current reports or portions thereof furnished under Item
2.02 or Item 7.01 of Form 8-K) subsequently filed by the Registrant pursuant to
Sections 13(a), 13(c), 14 and 15(d) of the Securities Exchange Act of 1934,
as amended (the “Exchange Act”), prior to the termination of the offering shall
be deemed to be incorporated by reference in this registration statement and to
be a part hereof from the date of filing of such documents; except as to any
portion of any future annual or quarterly report to stockholders or document
that is not deemed filed under such provisions. For the purposes of this
prospectus, any statement contained in a document incorporated or deemed to be
incorporated by reference herein shall be deemed to be modified or superseded to
the extent that a statement contained herein or in any other subsequently filed
document which also is or is deemed to be incorporated by reference herein
modifies or supersedes such statement. Any such statement so modified or
superseded shall not be deemed, except as so modified or superseded, to
constitute a part of this prospectus.
You may
request a copy of these documents, which will be provided to you at no cost, by
writing or telephoning us using the following contact information:
Generex
Biotechnology Corporation
Attention:
Mark Fletcher, Executive Vice President and General Counsel
33
Harbour Square, Suite 202
Toronto,
Ontario
Canada
M5J 2G2
(416)
364-2551
PROSPECTUS
GENEREX
BIOTECHNOLOGY CORPORATION
$150,000,000
Common Stock
Preferred
Stock
Warrants
Units
________
__. 2010
PART
II
INFORMATION
NOT REQUIRED IN PROSPECTUS
Item 14.
Other Expenses of
Issuance and Distribution
We will
pay all reasonable expenses incident to the registration of shares. Such
expenses are set forth in the following table. All of the amounts shown are
estimates except the SEC registration fee.
SEC
registration fee
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$
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10,695
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Legal
fees and expenses
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10,000
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Accounting
fees and expenses
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20,000
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Miscellaneous
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1,000
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Total
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$
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41,695
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Item 15.
Indemnification of
Directors and Officers
General
Corporation Law of Delaware
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 Restated Certificate of
Incorporation 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 corporation’s 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 By-Laws permit indemnification of directors,
officers, employees and other agents to the maximum extent permitted by Delaware
law. We currently maintain insurance under which the insurers will reimburse
Generex for amounts that it has paid to its directors and officers as
indemnification for claims against such persons in their official capacities.
The insurance also covers such persons as to amounts paid by them as a result of
claims against them in their official capacities that are not reimbursed by
Generex. The insurance is subject to certain limitations and
exclusions.
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.
Any
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
The
exhibits are described on the Exhibit Index to this Registration Statement on
Form S-3 on page 24.
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 the
volume of securities offered (if the total dollar value of securities
offered would not exceed that which was registered) and any deviation from
the low or high end of the estimated maximum offering range may be
reflected in the form of prospectus filed with the Commission pursuant to
Rule 424(b) if, in the aggregate, the changes in volume and price
represent no more than a 20 percent change in the maximum aggregate
offering price set forth in the “Calculation of Registration Fee” table in
the effective registration statement;
and
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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;
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provided, however
, that
paragraphs (1)(i), (1)(ii) and (1)(iii) 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 statement, or is
contained in a form of prospectus filed pursuant to Rule 424(b) that is
part of the registration statement.
(2) That,
for the purpose of determining any liability under the Securities Act of 1933,
each such post-effective amendment shall be deemed to be a new registration
statement relating to the securities offered 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 purposes of determining liability under the Securities Act of 1933 to any
purchaser:
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(i)
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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
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(ii)
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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.
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(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.
(6) That,
for purposes of determining any liability under the Securities Act of 1933, each
filing of the registrant’s annual report pursuant to Section 13(a) or
Section 15(d) of the Securities Exchange Act of 1934 (and, where
applicable, each filing of an employee benefit plan’s 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 offering of such securities at that time shall be deemed to be
the initial
bona fide
offering thereof.
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 of
1933 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.
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 Toronto, Province of Ontario, Canada, on
January 29, 2010.
GENEREX
BIOTECHNOLOGY
CORPORATION
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By:
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/s/ Anna
E. Gluskin
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Anna
E. Gluskin
President
and Chief 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 Anna E. Gluskin and Rose C. Perri and Mark Fletcher,
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 Generex Biotechnology Corporation 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 was signed by the following persons in the capacities and on the dates
indicated.
Signature
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Title
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Date
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/s/ Anna E. Gluskin
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President, Chief Executive Officer (Principal
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Anna E. Gluskin
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Executive Officer), Director
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January 29, 2010
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/s/ Rose C. Perri
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Chief Financial Officer (Principal Financial and
Accounting Officer), Chief Operating Officer,
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Rose C. Perri
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Director
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January 29, 2010
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/s/ John Barratt
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Director
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January 29, 2010
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John Barratt
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/s/ Brian T. McGee
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Director
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January 29, 2010
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Brian T. McGee
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/s/ Nola E. Masterson
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Director
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January 29, 2010
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Nola E. Masterson
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/s/ Stephen Fellows
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VP, Finance
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January 29, 2010
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Stephen Fellows
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EXHIBIT
INDEX
Exhibit
Number
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Description of Exhibit*
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1.1
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Form
of Underwriting Agreement.†
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3(i)
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Restated
Certificate of Incorporation of Generex Biotechnology Corporation
(incorporated by reference to Exhibit 4.1 to Generex Biotechnology
Corporation’s Post-Effective Amendment No. 1 to the Registration Statement
on Form S-8 filed on October 26, 2009)
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3(ii)
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Amended
and Restated Bylaws of Generex Biotechnology Corporation (incorporated by
reference to Exhibit 3.2(ii) to Generex Biotechnology Corporation’s Report
on Form 8-K filed December 5, 2007)
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4.1
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Form
of Common Stock Certificate (incorporated by reference to Exhibit 4.1 to
Generex Biotechnology Corporation’s Registration Statement on Form S-1
(File No. 333-82667) filed on July 12, 1999)
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4.2
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Form
of Common Stock Warrant Agreement (together with form of warrant
certificate)†
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4.3
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Form
of Preferred Stock Warrant Agreement (together with form of warrant
certificate)†
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4.4
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Form
of Certificate of Designation for Preferred Stock (including specimen
preferred stock certificate)†
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4.5
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Form
of Unit Agreement (including form of unit certificate)†
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5
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Opinion
of Eckert Seamans Cherin & Mellott, LLC
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23.1
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Consent
of Independent Registered Public Accounting Firm.
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23.2
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Consent
of Eckert Seamans Cherin & Mellott, LLC (included in Exhibit
5)
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24.1
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Power
of Attorney (see page 23)
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* In the
case of incorporation by reference to documents filed by the Registrant under
the Exchange Act, the Registrant’s file number under the Exchange Act is
000-25169.
† To be
filed by amendment or by a Current Report on Form 8-K and incorporated herein by
reference.