Unassociated Document
As
filed with the Securities and Exchange Commission on January 12,
2007.
Registration
No. 333-139637
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
AMENDMENT
NO. 1
FORM
S-3
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
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Eckert
Seamans Cherin & Mellott, LLC
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1515
Market Street, Ninth Floor
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Philadelphia,
Pennsylvania 19102-1909
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(215)
851-8400
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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, 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. £
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)(4)
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Common
Stock, par value $.001 per share(5)
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Preferred
Stock, par value $.001 per share(5)
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Warrants
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Units
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Total
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$
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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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16,050
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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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In
connection with the Registrant’s initial filing of this Registration on
Form S-3 on December 22, 2006, the full amount of the registration
fee of
$16,050 was previously paid.
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(5)
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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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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:
This
Pre-Effective Amendment No. 1 is being filed by the Registrant (i) to
register shares of Preferred Stock, par value $.001 per share, Warrants and
Units in addition to shares of Common Stock, par value $0.001 per share,
under
this Registration Statement on Form S-3; (ii) to revise the Use of Proceeds
set
forth in the prospectus included herein; (iii) to include descriptions of
the
Registrant’s Capital Stock, including Common Stock and Preferred Stock, the
Warrants and the Units in the prospectus included herein; (iv) to revise
and
restate the Plan of Distribution set forth in the prospectus included herein;
(v) to include the Registrant’s Current Report on Form 8-K filed on September
15, 2006 under the caption “ Incorporation of Document by Reference” in the
prospectus included herein; (vi) to revise and restate Item 15. Indemnification
of Directors and Officers; (vii) to revise and restate Item 17. Undertakings
to
include the undertaking required by Item 512(i) of Regulation S-K.; and (viii)
to revise and restate Item 16. Exhibits to expand the exhibits listed therein
in
connection with the registration of shares of Preferred Stock, par value
$.001
per share, Warrants and Units.
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 12, 2007
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 9, 2007, as reported by NASDAQ, was $1.68 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
2
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 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 , 2007
TABLE
OF CONTENTS
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Page
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Summary
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1
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Our
Company
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1
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About
This Prospectus
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1
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Risk
Factors
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2
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Cautionary
Note Regarding Forward-Looking Statements
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7
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Use
of Proceeds
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8
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Description
of Our Capital Stock
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8
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Description
of Our Warrants
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13
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Description
of Our Units
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14
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Plan
of Distribution
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15
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Legal
Matters
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16
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Experts
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16
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Where
You Can Find More Information
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17
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Incorporation
of Certain Documents by Reference
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17
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SUMMARY
The
summary description of our business may not contain all information that
may be
important to you. You should read this entire prospectus and any accompanying
prospectus supplement, including the information set forth “Risk Factors” and
our financial statements and related notes, included or incorporated by
reference in this prospectus or any prospectus supplement before making an
investment decision.
References
in this prospectus to “we,” “us,” “our,” “Generex” or the “company,” unless the
context requires otherwise, refer to Generex Biotechnology
Corporation.
Our
Company
Generex
Biotechnology Corporation is a Delaware corporation engaged in the research
and
development of injection-free methods for delivery of large molecule drugs.
We
are a development stage company.
To
date,
we have focused our efforts and resources on a platform technology to orally
administer large molecule drugs by absorption through the walls of the mouth
cavity. The mouth cavity is also known as the "buccal" cavity. Large molecule
drugs include proteins, hormones, peptides and vaccines. Large molecule drugs,
such as synthetic insulin, are presently administered almost exclusively by
injection.
The
initial product 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.
We
have
also pursued the application of our technology for the buccal delivery of
pharmaceutical products in addition to insulin, such as the buccal delivery
of
morphine, fentanyl citrate and low molecular weight heparin.
In
August
2003, we acquired Antigen Express, Inc., or Antigen. Antigen is engaged in
the
research and development of technologies for the treatment of malignant,
infectious, autoimmune and allergic diseases.
Our
organizational structure consists of Generex Biotechnology Corporation and
five
wholly-owned subsidiaries: Generex Pharmaceuticals Inc., which is incorporated
in Ontario, Canada and which performs all of our Canadian operations; Generex
(Bermuda), Inc., which is incorporated in Bermuda and which currently does
not
conduct any business activities; Antigen Express, Inc., which is incorporated
in
Delaware and which we acquired in 2003; Generex Pharmaceuticals (USA) LLC,
which
we organized in North Carolina in February 2006 and which has not yet commenced
any business operations; and Generex Marketing & Distribution Inc., which we
organized in Ontario, Canada in September 2006 and which has not yet commenced
any business operations.
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.
About
This Prospectus
This
prospectus is part of a registration statement that we have filed with the
Securities and Exchange Commission, or SEC, using the “shelf” registration
process. By using a shelf registration statement, we may, from time to time,
issue and sell in 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 offer securities, we will provide a prospectus supplement
that will contain specific information about the terms of that offering and
the
terms of the securities being sold. We will file each prospectus supplement
with
the SEC. The prospectus supplement may also add, update or change information
contained in this prospectus. You should read both this prospectus and any
prospectus supplement together with additional information described under
the
heading “Where You Can Find More Information” below.
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.
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 quarterly period ending October 31, 2006, we have
received nominal revenues from sales of our confectionary, Glucose RapidSpray™,
and we expect to receive some revenue from the sale of our oral insulin product
in Ecuador in the second quarter of fiscal 2007. To date, we have not been
profitable and our accumulated net loss available to common shareholders
was
$192,153,357 at October 31, 2006. 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 selling in Ecuador and Glucose
RapidSpray™ which we began selling in the United States in October 2006, 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 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 12 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.
Any
new equity financing will dilute current
stockholders.
If
we
raise funds through equity financing to meet the needs discussed above, it
will
have a 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.
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™ and Glucose RapidSpray™, our technologies and
products are at an early stage of development and we cannot expect 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™ and Glucose RapidSpray™. 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 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.
Although
Generex Oral-lyn™, our proprietary oral insulin spray formulation, has been
approved for commercial marketing and sale in Ecuador, and Glucose RapidSpray™,
our confectionary product, will be available for purchase in the United States,
we have yet to manufacture, market and distribute these products on a
large-scale commercial basis. 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 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.
Only
our
oral insulin product has been approved for commercial sale by drug regulatory
authorities, and that approval was obtained in Ecuador. We have begun the
regulatory approval process for our oral insulin, buccal morphine and fentanyl
products in other countries. Our immunomedicine products are in the pre-clinical
stage of development, with the exception of our Phase 1 trial in human patients
with stage II HER-2/neu positive breast cancer.
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 country
other than Ecuador.
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 prospectus
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 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 country other than Ecuador, 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 products are approved for
sale.
Even
if
we obtain regulatory approval to market our oral insulin product or any other
prescription pharmaceutical product candidate in another country other than
Ecuador, many factors may prevent the product from ever being sold in commercial
quantities. Similarly, the successful commercialization of our confectionary
may
be hindered. 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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·
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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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·
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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™ in Ecuador or Glucose
RapidSpray™ in the United States or any of our other products that may receive
regulatory approval until we can successfully manufacture, market and distribute
them in the relevant market.
We
will
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. Accordingly, our
competitors may succeed in developing competing technologies, obtaining FDA
approval for products or gaining market acceptance more rapidly than we can.
In
January, 2006, the FDA approved Pfizer, Inc.’s inhalable form of insulin, the
first non-injected insulin to be approved by the FDA. Pfizer’s product in
inhaled through the mouth and absorbed in the lungs. Initial supplies of this
product, which is marketed as Exubera®, became available in the U.S. in
September 2006. We understand that an expanded roll-out of Exubera® to
primary-care physicians in the U.S., which Pfizer previously targeted for
November 2006, will begin in January 2007. While we believe that absorption
though the buccal cavity offers several advantages over absorption through
the
lungs, Pfizer’s early approval could allow it to capture a large portion of the
market.
If
government programs and insurance companies do not agree to pay for or reimburse
patients for our products, our success will be
impacted.
Sales
of
our oral insulin formulation in Ecuador and our potential products in other
markets 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
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.
In
the
past, we have failed to comply with certain of NASDAQ’s listing requirements. In
late 2004, we did not comply with NASDAQ Rule 4310(c)(2)(B) which requires
us to
have a minimum of $2,500,000 in stockholders' equity or $35,000,000 market
value
of listed securities or $500,000 of net income from continuing operations for
the most recently completed fiscal year or two of the three most recently
completed fiscal years. While we regained compliance with this standard, we
are
still in the development stage. Consequently, there is no guarantee that we
will
sustain compliance with this standard. In the event we cannot sustain
compliance, our shares of common stock may be delisted from the NASDAQ Capital
Market and begin trading on the over-the-counter bulletin board, assuming we
meet the requisite criteria.
In
addition, from October 2004 until October 2005, we failed to comply with NASDAQ
Rule 4310(c)(4) which requires us to have a minimum bid price per share of
at
least $1.00. Although we regained compliance with the minimum bid price
requirement in November 2005, there is no guarantee that the bid price of our
common stock will remain at or above $1.00 per share. In the event that the
price of our common stock falls below $1.00 per share for thirty (30)
consecutive trading days, we would likely receive a notice from the NASDAQ
Stock
Market LLC informing us of our noncompliance with NASDAQ Rule 4310(c)(4) and
giving us 180 calendar days, subject to extension, to regain compliance with
the
rule. In the event that we could not demonstrate compliance with NASDAQ Rule
4310(c)(4) by the specified deadline and were not eligible for an additional
compliance period, the staff would notify us that our stock would be delisted,
at which time we could appeal the staff’s determination to a Listing
Qualifications Panel. Pending the decision of the Listing Qualification Panel,
our common stock would continue to trade on the NASDAQ Capital Market. If we
were not successful in such an appeal, our stock would likely trade on NASDAQ’s
over-the-counter bulletin board, assuming we meet the requisite
criteria.
If
we fail to maintain compliance with applicable NASDAQ Rules and our stock is
delisted from the NASDAQ Capital Market, it may become subject to Penny Stock
Regulations and there will be less interest for our stock in the market. This
may result in lower prices for our stock and make it more difficult for us
to
obtain financing.
If
our
stock is not listed on NASDAQ and fails to maintain a price of $5.00 or more
per
share, our stock would become subject to the Securities and Exchange
Commission's "Penny Stock" rules. These rules require a broker to deliver,
prior
to any transaction involving a Penny Stock, a disclosure schedule explaining
the
Penny Stock Market and its risks. Additionally, broker/dealers who recommend
Penny Stocks to persons other than established customers and accredited
investors must make a special written suitability determination and receive
the
purchaser's written agreement to a transaction prior to the sale. In the event
our stock becomes subject to these rules, it will become more difficult for
broker/dealers to sell our common stock. Therefore, it may be more difficult
for
us to obtain financing.
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.
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.
CAUTIONARY
NOTE REGARDING FORWARD-LOOKING STATEMENTS
We
have
made statements in this prospectus that may be forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995. These
statements can be identified by introductory words such as "expects," "plans,"
"intends," "believes," "will," "estimates," "forecasts," "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
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our
expectations of when regulatory submissions may be filed or when
regulatory approvals 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;
and
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the
inherent uncertainties associated with commercialization of products
that
have received regulatory approval.
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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 made in this prospectus 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 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.
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
(the “Certificate of Incorporation”) and our 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) 500,000,000 shares of common stock,
par value $.001 per share, of which 108,157,688 shares were outstanding as
of
January 9, 2007 (ii) 1,000,000 shares of undesignated preferred stock, par
value
$.001 per share, and (iii) 1,000 shares of Special Voting Rights Preferred
Stock
outstanding.
Common
Stock
Holders
of common stock are entitled to one vote for each share owned 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.
Special
Voting Rights Preferred Stock
We
have
1,000 shares of Special Voting Rights Preferred Stock outstanding. Dr. Pankaj
Modi, our former director and Vice President, Research and Development, is
the
owner of all of these shares. The Special Voting Rights Preferred Stock is
not
convertible into shares of our common stock.
The
Special Voting Rights Preferred Stock has the following special voting
rights:
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the
Special Voting Rights Preferred Stock has the right to elect a
majority of
our Board of Directors if a “Change of Control” (as specifically defined)
occurs;
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the
Special Voting Rights Preferred Stock has the right to approve
any
transaction that would result in a Change of Control;
and
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the
Special Voting Rights Preferred Stock has the right to vote whenever
specifically required by Delaware
law.
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The
Special Voting Rights Preferred Stock is entitled to share in dividends paid
on
the common stock.
We
have
the right to redeem the Special Voting Rights Preferred Stock at any time
for
$.10 per share. We expect that the Board of Directors will take action in
due
course to redeem the Special Voting Rights Preferred Stock.
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 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
purchase price;
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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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voting
rights, if any;
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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 Certificate of Incorporation and 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.
Special
Voting Rights Preferred Stock:
As
indicated above, our outstanding Special Voting Rights Preferred Stock prevents
a "Change of Control" of Generex without the consent of the holders of those
shares. At the present time, all of these shares are owned by Dr. Modi, our
former director and Vice President, Research and Development.
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 other than the Special Voting Rights 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
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 the company does 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 the company’s proxy statement, notice of such
proposal must be received not less than 120 days prior to the first anniversary
of the date of the company’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
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
right
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. Holders of our Special Voting Rights Preferred Stock are entitled
to
receive a dividend per share equal to the dividends paid on share of common
stock when and if such dividends are declared and 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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The
aggregate number of such warrants;
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The
price or prices at which such warrants will be issued;
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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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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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The
price at which the securities issuable upon exercise of such
warrants may
be acquired;
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The
dates on which the right to exercise such warrants will commence
and
expire;
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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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if
applicable, the minimum or maximum amount of such warrants that
may be
exercised at any one time;
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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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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:
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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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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:
·
directly
to purchasers;
·
to
or
through underwriters;
·
through
dealers or agents;
·
in
privately negotiated transactions; or
·
through
a
combination of methods.
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:
·
the
names
of the underwriters, dealers or agents, if any,
·
the
terms
of the securities being offered, including the purchase price of the securities
and the net proceeds to us,
·
any
underwriting discounts and other items constituting underwriters’ compensation,
·
any
over-allotment options under which underwriters may purchase additional
securities from us, and
·
any
discounts or concessions allowed or reallowed or paid to dealers and any
securities exchanges on which the securities may be listed.
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.
We
have
not entered into any agreements, understandings or arrangements with any
underwriters, broker-dealers or other parties regarding the sale of securities.
As of the date of this prospectus, there were no special selling arrangements
between any broker-dealer or other person and the company. No period of time
has
been fixed within which the securities will be offered or sold.
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.
LEGAL
MATTERS
The
validity of the issuance of the securities offered in this prospectus will
be
passed upon for us by Eckert Seamans Cherin & Mellott, LLC, 1515 Market
Street, 9th Floor, Philadelphia, PA 19102. Certain members of the firm of
Eckert
Seamans Cherin & Mellott hold options that are exercisable for 30,000 shares
at $7.56 per share. These options were granted under our 2000 Stock Option
Plan.
Members of the firm also 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
audited financial statements for the fiscal year ended July 31, 2006 and
management’s assessment of the effectiveness of internal control over financial
reporting (which is included in Management’s Report on Internal Control over
Financial Reporting) incorporated in this prospectus by reference to the Annual
Report on Form 10-K for the year ended July 31, 2006 have been so incorporated
in reliance on the report of Danziger & Hochman, Chartered Accountants, an
independent registered public accounting firm, given on the authority of said
firm as experts in auditing and accounting. The audited financial statements
for
the fiscal years ended July 31, 2005 and 2004 incorporated in this prospectus
by
reference to the Annual Report on Form 10-K for the year ended July 31, 2006
have been so incorporated in reliance on the report of BDO Dunwoody LLP, an
independent registered public accounting firm, given on the authority of said
firm as experts in auditing and accounting.
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 have been filed by us with
the SEC and are incorporated herein by reference:
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Our Annual Report on Form 10-K for the fiscal year
ended July 31, 2006;
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Amendment
No. 1 to our Annual Report on Form 10-K for the fiscal year ended
July 31, 2006;
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Our
Quarterly Report on Form 10-Q for the quarter ended October 31, 2006;
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Our
Current Report on Form 8-K filed on September 14, 2006;
and
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The
description of our common stock contained in our registration statement
on
Form 10 filed on December 14, 1998, as amended by a Form 10/A filed
on
February 24, 1999, and including any amendment or report subsequently
filed for the purpose of update the description.
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All
documents 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
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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16,050
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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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47,050
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Item 15.
Indemnification
of Directors and Officers
General
Corporation Law of Delaware
Section
145 of the Delaware General Corporation Law authorizes a corporation to
indemnify its directors, officers, employees or other agents in terms
sufficiently broad to permit indemnification (including reimbursement for
expenses incurred) under certain circumstances for liabilities arising under
the
Securities Act. Our By-Laws (Exhibit 3(ii) hereto) provide indemnification
of
our directors and officers to the maximum extent permitted by the Delaware
General Corporation Law.
By-Laws
Article
V
of our By-Laws provides that the company shall indemnify any person who was
or
is a party or threatened to be made a party to any threatened, pending or
completed action, suit or proceeding, whether civil, criminal, administrative
or
investigative (collectively, a "proceeding"), by reason of the fact such
person
is or was (a) a director or executive officer of the company or a constituent
corporation absorbed in a consolidation or merger (hereinafter, a "constituent
corporation"), or, (b) is or was serving at the request of the company or
a
constituent corporation as a director, officer, partner, employee or agent
of
another corporation, partnership, joint venture or other enterprise or entity,
or (c) is or was a director or officer of the company serving at its request
as
an administrator, trustee or other fiduciary of one or more of the employee
benefit plans, if any, of the company or another entity which may be in effect
from time to time, against all expenses, liability and loss actually and
reasonably incurred or suffered by such person in connection with such
proceeding, whether or not the indemnified liability arises or arose from
any
proceeding by or in the right of the company, to the extent that such person
is
not otherwise indemnified and to the extent that such indemnification is
not
prohibited
by law as it presently exists or may hereafter be amended. The company shall
advance all expenses reasonably incurred by a person entitled to indemnification
as provided above in defending a proceeding in advance of the final disposition
of such proceeding, and may, but shall not be obligated to, advance expenses
of
other persons entitled to indemnification pursuant to any other agreement
or
provision of law. To determine whether any indemnification under Article
V of
our By-Laws is permissible, the Board of Directors of the company by a majority
vote of a quorum consisting of directors not parties to such proceeding may,
and
on request of a person seeking indemnification shall be required to, determine
in each case whether the applicable standards in any applicable statute have
been met, or such determination shall be made by independent legal counsel
if
such quorum is not obtainable, or, even if obtainable, a majority vote of
a
quorum of disinterested directors so directs. If a claim for indemnification
under Article V of our By-Laws is not paid in full within ninety (90) days
after
a written claim therefor has been received by the company, the claimant may
file
suit to recover the unpaid amount of such claim, and the company shall have
the
burden of proving that the claimant was not entitled to the requested
indemnification under applicable law. The reasonable expenses of any person
in
prosecuting a successful claim for indemnification thereunder, and the fees
and
expenses of any independent legal counsel engaged to determine permissibility
of
indemnification, shall be borne by the company. For purposes of Article V,
"independent legal counsel" means legal counsel other than that regularly
or
customarily engaged by or on behalf of the company. Notwithstanding any other
provision of Article V of our Bylaws, the company shall be required to indemnify
a person in connection with a proceeding initiated by such person only if
the
proceeding was authorized by the Board.
Article
V
of our Bylaws further provides that indemnification provided therein shall
not
be deemed exclusive of any other right to which one seeking indemnification
may
have or hereafter acquire under any statute, provision of the Certificate
of
Incorporation, the By-Laws, agreement, vote of stockholders or disinterested
directors or otherwise, and shall inure to the benefit of the heirs, executors
and administrators of any such person. Any modification or repeal of any
provision of Article V of our By-Laws shall not adversely affect any right
or
protection of an authorized representative existing thereunder with respect
to
any act or omission occurring prior to such modification or
repeal.
Pursuant
to Article V of our By-Laws, the Board of Directors of the company has the
power
to (i) authorize the company to purchase and maintain, at the company’s
expenses, insurance on behalf of the company and on behalf of others to the
extent that power to do so has not been prohibited by applicable law, and
(ii)
give other indemnification to the extent not prohibited by applicable law.
The
company currently maintains insurance under which the insurers will reimburse
the company 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 the
company. The insurance is subject to certain limitations and
exclusions.
Item
16.
Exhibits
The
exhibits are described on the Exhibit Index to this Registration Statement
on
Form S-3.
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:
(i)
To
include any prospectus required by Section 10(a)(3) of the Securities Act
of 1933;
(ii)
To
reflect in the prospectus any facts or events arising after the effective date
of the registration statement (or the most recent post-effective amendment
thereof) which, individually or in the aggregate, represent a fundamental change
in the information set forth in the registration statement. Notwithstanding
the
foregoing, any increase or decrease in 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
(iii)
To
include any material information with respect to the plan of distribution not
previously disclosed in the registration statement or any material change to
such information in the registration statement;
provided,
however,
that
paragraphs (i), (ii) and (iii) do not apply if 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:
(i) If
the
registrant is relying on Rule 430B:
(A) Each
prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be
deemed to be part of the registration statement as of the date the filed
prospectus was deemed part of and included in the registration
statement; and
(B)
Each
prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5) or
(b)(7) as part of a registration statement in reliance on Rule 430B
relating to an offering made pursuant to Rule 415(a)(1)(i), (vii) or
(x) for the purpose of providing the information required by
section 10(a) of the Securities Act of 1933 shall be deemed to be part of
and included in the registration statement as of the earlier of the date such
form of prospectus is first used after effectiveness or the date of the first
contract of sale of securities in the offering described in the prospectus.
As
provided in Rule 430B, for liability purposes of the issuer and any person
that is at that date an underwriter, such date shall be deemed to be a new
effective date of the registration statement relating to the securities in
the
registration statement to which that prospectus relates, and the offering of
such securities at that time shall be deemed to be the initial
bona
fide
offering
thereof.
Provided, however
, that
no statement made in a registration statement or prospectus that is part of
the
registration statement or made in a document incorporated or deemed incorporated
by reference into the registration statement or prospectus that is part of
the
registration statement will, as to a purchaser with a time of contract of sale
prior to such effective date, supersede or modify any statement that was made
in
the registration statement or prospectus that was part of the registration
statement or made in any such document immediately prior to such effective
date.
(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)
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.
(8) The
undersigned registrant hereby undertakes that:
(i)
For purposes of determining any liability under the Securities Act of 1933,
the
information omitted from the form of prospectus filed as part of this
registration statement in reliance upon Rule 430A and contained in a form
of prospectus filed by the registrant pursuant to Rule 424(b)(1) or
(4) or 497(h) under the Securities Act shall be deemed to be part of this
registration statement as of the time it was declared effective.
(ii) For
the purpose of determining any liability under the Securities Act of 1933,
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.
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 Amendment No.
1 to
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 12, 2007.
GENEREX
BIOTECHNOLOGY CORPORATION
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Anna
E. Gluskin
President
and Chief Executive Officer
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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
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Anna
E. Gluskin
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And
Director
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January
12, 2007
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*
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Chief
Financial Officer,
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Rose
C. Perri
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Chief
Operating Officer and Director
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January
12, 2007
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*
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Vice
President, Director
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January
12, 2007
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Gerald
Bernstein, M.D.
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*
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Director
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January
12, 2007
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Mindy
Allport-Settle
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*
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Director
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January
12, 2007
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John
Barratt
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*
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Director
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January
12, 2007
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Peter
Amanatides
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*
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Director
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January
12, 2007
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Brian
T. McGee
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*
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Director
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January
_12, 2007
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David
Wires
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*
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Controller
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January
12, 2007
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Slava
Jarnitskii
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*By: /s/
Anna E. Gluskin
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Anna
E. Gluskin
Attorney-in-fact
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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,
as
amended (incorporated by reference to Exhibit 3(II) to Generex
Biotechnology Corporation’s Current Report on Form 8-K filed on June 19,
2006)
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3(ii)
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Bylaws
of Generex Biotechnology Corporation (incorporated by reference
to Exhibit
3.2 to Generex Biotechnology Corporation’s Registration Statement on Form
S-1 (File No. 333-82667) filed on July 12, 1999)
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4.1
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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 Danziger & Hochman, Chartered Accountants
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23.2
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Consent
of BDO Dunwoody LLP
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23.3
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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 (previously
filed)
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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 as an exhibit to a report filed pursuant to Sections 13(a), 13(c) or
15(d)
of the Exchange Act or by post-effective amendment to the Registration
Statement.