UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date
of
Report (Date of earliest event reported): June 20, 2006
GENEREX BIOTECHNOLOGY
CORPORATION
(Exact
Name of Registrant as Specified in Its Charter)
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Delaware
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000-25169
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98-0178636
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(State
or Other
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(Commission
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(IRS
Employer
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Jurisdiction
of
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File
Number)
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Identification
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Incorporation)
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Number)
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33
Harbour Square, Suite 202, Toronto, Ontario Canada
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M5J
2G2
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(Address
of Principal Executive Offices)
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(Zip
Code)
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Registrant’s
telephone number, including area code: (416)
364-2551
N/A
(Former
name or former address, if changed since last report.)
Check
the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions (see
General
Instruction A.2. below):
o Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
o Soliciting
material pursuant to Rule 14a-12 under
the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement
communications pursuant to Rule
14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement
communications pursuant to Rule
13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item
1.01. Entry
into a Material Definitive Agreement.
On
June
20, 2006, Generex Biotechnology Corporation (the “Company”) entered into an
agreement with Cardinal Health PTS, LLC (“Cardinal Health”), a subsidiary of
Cardinal Health, Inc., pursuant to which Cardinal Health will manufacture
clinical trial batches of the Company’s proprietary oral insulin spray product,
Generex Oral-lyn™. Under the terms of the agreement, Cardinal Health will
formulate and fill clinical trial batches of canisters at its manufacturing
and
analytical services facility in Research Triangle Park, North Carolina. Cardinal
Health will schedule production after certain conditions are satisfied,
including the execution of a Quality Agreement between the parties and receipt
of a purchase order from the Company. The parties’ performance under the
agreement will be subject to a Clinical Supply Agreement, which the parties
expect to enter at a later date.
Either
party may terminate the agreement, or any portion thereof, at any time by
providing the other party with 45 days’ written notice. In the event that the
Company terminates the agreement, Cardinal Health will attempt to minimize
or
avoid further expenses by scaling down its ongoing work. In the event of
termination, the Company will be responsible for paying the costs incurred
by
Cardinal Health for all work performed prior to termination, any
samples/materials/equipment/supplies purchased specifically for this project
and
efforts to scale-down work following termination, as well as certain
cancellation fees.
Cardinal
Health’s total liability under the agreement is capped at an amount equal to the
total fees paid by the Company under the agreement, and neither party will
be
liable to the other for indirect, incidental, special or consequential damages
arising out of its performance under the agreement. The Company is obligated
to
indemnify Cardinal Health for any third-party claims arising directly or
indirectly from: (i) the manufacture, marketing, distribution or sale, or use
of
or exposure to, Generex Oral-lyn™ and materials supplied by the Company: (ii)
the Company’s negligence or willful misconduct; (iii) the Company’s breach of
the agreement; or (iv) the use of any intellectual property provided by the
Company to Cardinal Health.
Prior
to
entering into the agreement, no material relationship existed between the
Company and its affiliates and Cardinal Health.
The
Company intends to file the agreement, subject to a request for confidential
treatment for certain of its terms, as an exhibit to its Report on Form 10-K
for
the year ended July 31, 2006.
Forward-Looking
Statements
This
Report contains "forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995, which are subject to the safe harbors
created thereby. These statements can be identified by introductory words such
as "expects," "intends," "will," “may,” "estimates" or words of similar meaning,
and by the fact that they do not relate strictly to historical or current facts.
Forward-looking statements frequently are used in discussing potential product
applications, potential collaborations, product development activities, clinical
studies, regulatory submissions and approvals, and similar operating matters.
Many factors may cause actual results to differ from forward-looking statements,
including inaccurate assumptions and a broad variety of risks and uncertainties,
some of which are known and others of which are not. Known risks and
uncertainties include those identified from time to time in the reports filed
by
the Company with the Securities and Exchange Commission, which should be
considered together with any forward-looking statement. No forward-looking
statement is a guarantee of future results or events, and one should avoid
placing undue reliance on such statements. The Company cannot be sure when
or if
it will be permitted by regulatory agencies to undertake additional clinical
trials or to commence any particular phase of clinical trials. Because of this,
statements regarding the expected timing of clinical trials cannot be regarded
as actual predictions of when the Company will obtain regulatory approval for
any “phase” of clinical trials.
SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
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GENEREX
BIOTECHNOLOGY CORPORATION
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Date: June
22, 2006
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By:
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/s/
Rose C. Perri
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Chief
Operating Officer and
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Chief
Financial Officer
(principal
financial officer)
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