8-k
Item 8.01 Other Events.
On February 8, 2021, Generex Biotechnology Corporation and its majority owned public entity NuGenerex Immuno-Oncology, Inc., (collectively “Generex”) received a wire transfer of Two Million Dollars USD ($2,000,000.00) towards its COVID-19 vaccine development initiatives from its China Partners (as defined below) pursuant to 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 date Generex has received a total of Three Million One Hundred Thousand Dollars USD ($3,100,000.00) from the China Partners, broken down as follows:
1. One Hundred Thousand Dollar USD ($100,000.00) “Performance Guarantee Fee” payment.
2. Three Million Dollars USD ($3,000,000.00) towards its COVID-19 vaccine development initiatives.
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. Lastly, Generex filed a FORM 8K for the signed January 6, 2021, Performance Guarantee Fee Agreement on January 8, 2021.
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.
Item 8.01 Other Events.
On February 8, 2021, Generex Biotechnology Corporation and its majority owned public entity NuGenerex Immuno-Oncology, Inc., (collectively “Generex”) received a wire transfer of Two Million Dollars USD ($2,000,000.00) towards its COVID-19 vaccine development initiatives from its China Partners (as defined below) pursuant to 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 date Generex has received a total of Three Million One Hundred Thousand Dollars USD ($3,100,000.00) from the China Partners, broken down as follows:
1. One Hundred Thousand Dollar USD ($100,000.00) “Performance Guarantee Fee” payment.
2. Three Million Dollars USD ($3,000,000.00) towards its COVID-19 vaccine development initiatives.
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. Lastly, Generex filed a FORM 8K for the signed January 6, 2021, Performance Guarantee Fee Agreement on January 8, 2021.
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.
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