SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 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) September 5, 2000
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Generex Biotechnology Corporation
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(Exact name of registrant as specified in its charter)
Delaware 000-25169 82-049021
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(State or other jurisdiction (Commission (IRS Employer
of Incorporation) File Number) Identification No.)
33 Harbor Square, Suite 202, Toronto, Ontario Canada M5J 2G2
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code 416/364-2551
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(Former name or former address, if changed since last report)
Item 5. Other Events
Generex has entered into a Development and License Agreement with Eli Lilly
and Company ("Lilly") to develop a buccal formulation of insulin that is
administered as a fine spray into the buccal (oral) cavity using Generex
proprietary technology. Clinical trials of the initial product candidate are
underway in North America and Europe. Depending on the success of the initial
insulin product, Lilly has the option under the Agreement to develop a number of
other products using Generex technology.
Under the terms of the Agreement, Generex will receive certain initial fees
and milestone payments. Generex also is entitled to receive royalties based on
product sales. Lilly, generally, will be responsible for conducting clinical
trials, securing regulatory approvals and marketing on a worldwide basis for all
products developed under the Agreement. Generex will be responsible for
continuing development work as required on it's formulation and on it's
RapidMist(TM) device that is used to administer the formulation.
A redacted copy of the Agreement will be filed by amendment as an exhibit
to this Report. The redacted copy will omit certain provisions of the Agreement
that contain trade secrets and/or confidential commercial or financial
information. A copy of the Agreement containing such information will be filed
separately with the Securities and Exchange Commission concurrently with the
filing of the redacted version as an exhibit to this Report.
Item 7. Financial Statements and Exhibits
(a) Financial Statements.
None.
(b) Exhibits.
The following Exhibit will be filed by amendment to this Report:
Exhibit A Development and License Agreement with Eli Lilly and Company dated
September 5, 2000, redacted to omit trade secrets and confidential
commercial and financial information.
SIGNATURES
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.
GENEREX BIOTECHNOLOGY CORPORATION
Dated: September 6, 2000 By: /s/ E. Mark Perri
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E. Mark Perri, Chairman and CFO