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.
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.
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