Item 1.01 Entry into a Material Definitive Agreement.
On January 6, 2021, Generex Biotechnology Corporation and its majority owned
entity NuGenerex Immuno-Oncology, Inc., (collectively "Generex") agreed to
accept a One Hundred Thousand Dollar USD ($100,000.00) "Performance Guarantee
Fee" payment to extend, for a second time, the Five Million Dollar USD
($5,000,000.00) upfront licensing fee payment from the "Joint Entity" (the
"Performance Guarantee Fee Agreement") as set forth under the Ii-Key Innovative
Vaccine Development Agreement signed November 13, 2020, as amended by the
extension terms signed December 15, 2020 (collectively 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 Five Million Dollar USD ($5,000,000.00)
upfront licensing fee payment that is due from the Joint Entity was delayed due
to unexpected additional complicated procedures to set up the new Joint Entity
and get the necessary approvals to transfer the fees out of China than
originally planned.
The Performance Guarantee Fee Agreement requires the Joint Entity to pay Generex
a One Hundred Thousand Dollar USD ($100,000.00) "Performance Guarantee Fee"
payment imminently when bank opens via an electronic wire; Generex was notified
that such was sent January 8, 2021.
Generex filed a FORM 8K for the signed November 13, 2020, Ii-Key Innovative
Vaccine Development Agreement on November 18, 2020. Also, Generex filed a FORM
8K/A for the signed December 15, 2020, Extension Agreement on December 17, 2020.
This Current Report contains summaries of the material terms of the Performance
Guarantee Fee Agreement. The summary of the Performance Guarantee Fee Agreement
contained in this Current Report is subject to, and is qualified in its entirety
by, reference to the Performance Guarantee Fee Agreement, which is filed as an
exhibit hereto and incorporated herein by reference.
A copy of the Performance Guarantee Fee Agreement signed January 6, 2021, 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.
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Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. Description
99.1 The Performance Guarantee Fee Agreement signed January 6, 2021
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Performance Guarantee Fee
January 6, 2021
When preform the contract number: YF202011-A signed on November 13, 2020, the
payment was delayed due to more complicated procedures than the originally
planned. Now Beijing Youfeng Biological Co. LTD, "the Joint Entity" which is
setup by largest shareholder Bejing Youfeng International Consulting Co., Ltd.,
is willing to pay $100,000 as the Performance Guarantee Fee. USD $100,000 will
be electronically wired to Generex imminently when bank opens.
Generex Biotechnology Corporation, acknowledge and accept the Performance
Guarantee Fee against contract YF202011-A from Beijing Youfend Biological
Technology Co. LTD.
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