Item
1.01 Entry into a Material Definitive Agreement.
On
December 15, 2020, Generex Biotechnology Corporation and its majority owned entity NuGenerex Immuno-Oncology, Inc., (collectively
“Generex”) agreed and signed an extension for the receipt of the Five Million Dollar USD ($5,000,000.00) upfront licensing
fee payment from the “Joint Entity” (the “Extension Agreement”) as set forth under the Ii-Key Innovative
Vaccine Development Agreement signed November 13, 2020 (the “Agreement”), with Beijing Youfeng International Consulting
Co., Ltd (“BYIC”), National Institute for Viral Disease Control and Prevention, Chinese Centre for Disease Control
and Prevention (“NIVDC”) and Beijing Guoxin Haixiang Equity Investment Partnership (“BGHEIP” and together
with BYIC and NIVDC, the “China Partners”) to set up a joint research team and a joint entity in China (the “Joint
Entity”) that shall jointly develop and industrialize the Generex internationally patented Ii-Key innovative technology
for a SARS-CoV-2 coronavirus peptide vaccine (the “Vaccine”) and other vaccines in the People’s Republic of
China (“China”) and for Generex to provide the Joint Entity with an exclusive license to use its intellectual property;
technical know-how, pre-clinical and clinical data and background materials, in each case, relating to Ii-Key-SARS-CoV-2 technology
in the People’s Republic of China, including Hong Kong Special Administrative Region and Macau Special Administrative Region,
but excluding the Islands of Taiwan (the “Licensed Territory”).
The
Extension Agreement allows for the Five Million Dollar USD ($5,000,000.00) upfront licensing fee payment to be made to Generex
no later than before December 31, 2020.
This
Current Report contains summaries of the material terms of the Extension Agreement. The summary of the Extension Agreement contained
in this Current Report is subject to, and is qualified in its entirety by, reference to the Extension Agreement, which is filed
as an exhibit hereto and incorporated herein by reference.
A
copy of the Extension Agreement signed December 15, 2020, is filed as Exhibit 99.1 to this Current Report.
Ii-Key
Platform Overview
The
Ii-Key-SARS-CoV-2 vaccine is designed as a “Complete Vaccine” that has the potential to induce the T-Cell and antibody
immune responses that can provide protective immunity with long-lasting immunologic memory against SARS-CoV-2 in a highly specific
manner to ensure safety. Ii-Key is a platform technology enabled by the amino acid key sequence “LRMK” that is shared
across the platform. The LRMK key sequence works by its ability to deliver any desired peptide epitope of interest directly to
the MHC Class 2 complex on the surface of antigen presenting cells. Once a suitable target epitope is identified, an Ii-Key vaccine
candidate is created by means of synthetic peptide synthesis, which produces a single linear amino acid chain that includes the
Ii-Key sequence, a short inert linker sequence, and the target epitope of interest. In this way, the target epitope is delivered
by the Ii-Key sequence directly to antigen presenting cells, resulting in an immune system stimulation.
About
the China Partners
Beijing
Youfeng International Consulting Co., Ltd. is the "China High-tech Industrialization Research Society Public Health Working
Committee" to provide development strategy consulting and design, projects implementation and management.
National
Institute for Viral Disease Control and Prevention of Chinese Centre for Disease Control (CDC) and Prevention is an independent
legal entity under the CDC. It is also the only national-level research institution for the prevention and control of viral diseases
and medical virology in China.
Beijing
Guoxin Haixiang Equity Investment Partnership (Limited Partnership) is a limited partnership established by Beijing Guoxin Zhongshu
Management Co., Ltd. as an executive partner and Zhejiang Haixiang Pharmaceutical Co., Ltd. and is effectively existing. Beijing
Guoxin Zhongshu Management Co., Ltd. is an equity investment institution which has completed the registration of private fund
manager in China Securities Investment Fund Industry Association. Zhejiang Haixiang Pharmaceutical Co., Ltd. is a public company
that mainly produces specialty APIs, preparations and fine chemicals, and has large-scale production capabilities for peptide
preparations.
Forward-Looking
Statements
Statements
in this report may contain certain forward-looking statements. All statements included concerning activities, events or developments
that the Generex expects, believes or anticipates will or may occur in the future are forward-looking statements. Actual results
could differ materially from the results discussed in the forward-looking statements. Forward-looking statements are based on
current expectations and projections about future events and involve known and unknown risks, uncertainties and other factors
that may cause actual results and performance to be materially different from any future results or performance expressed or implied
by forward-looking statements. Known risks and uncertainties also include those identified from time to time in the reports filed
by Generex 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.
Generex undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future
events or otherwise. Generex 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 or ultimate regulatory approval cannot be regarded as actual predictions of when Generex will obtain regulatory approval
for any “phase” of clinical trials or when it will obtain ultimate regulatory approval by a particular regulatory
agency. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities
Litigation Reform Act. Additional information on these and other risks, uncertainties and factors is included in the Company’s
Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8- K and other documents filed with the SEC.