Item 1.01 Entry into a Material Definitive Agreement.
On September 18, 2020, Generex Biotechnology Corporation and its majority owned subsidiary NuGenerex Immuno-Oncology, Inc., (collectively “Generex”) signed an agreement, called a Heads of Agreement, binding the August 14, 2020 memorandum of understanding (MOU) with Bintai Kinden Corporation of Malaysia (“Bintai”) for the development and commercialization of the Ii-Key-SARS-CoV-2 coronavirus vaccine (the “Agreement”). The Agreement, among other things, also expanded an understanding between Generex and Bintai (the “Parties”) related to the following:
1. Finalize and solidify the terms and conditions of the licensing agreement within TWO (2) weeks from the date of the Agreement, wherein the Parties will complete its perusal, clarify and finalization of the terms and conditions of the Agreement.
2. Parties agree to be bound by the terms from the original non-binding MOU and Parties are in legal process to effectuate and finalize the Contract Document.
3. Parties agree that Generex shall at all aspects procure all documentations, permits, consents, and approvals for the full approval of FDA for the said Vaccine.
4. As outlined in the MOU, Bintai will pay Generex the following fees:
a. $2,500,000 - Intellectual Properties “IP” Assignment Rights
b. $100,000 – Regulatory Fees
c. $25,000 – Legal Fees
d. $7,500,000 – Government of Malaysia Licensing Fees
e. $10,000,000 – Private Sector Licensing Fees
f. $3.00 Per Dose – Government of Malaysia Royalties Fees
g. $4.50 Per Dose - Private Sector Royalties Fees
This Current Report contains summaries of the material terms of the Agreement. The summary of the Agreement contained in this Current Report is subject to, and is qualified in its entirety by, reference to the Agreement, which is filed as an exhibit hereto and incorporated herein by reference.
A copy of the Agreement signed September 18, 2020, is filed as Exhibit 99.1 to this Current Report.
On September 18, 2020, Generex issued a press release announcing the Agreement with Bintai as described above, a copy of which is filed as Exhibit 99.2 to this Current Report.
A copy of the MOU signed August 14, 2020, is filed as Exhibit 99.3 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 Bintai Kinden
With over 40 years of specialist engineering and construction experience, Bintai’s unique combination of extensive regional experience and local knowledge has made them the region’s international contractor of choice. Headquartered in Malaysia, Bintai Kinden has expanded operations regionally throughout South-East Asia, China and the Arabian Gulf region.
As multi-disciplined, building and industrial service engineers and specialists, Bintai works in all the major market sectors, from commercial buildings to industrial complexes, designing, installing and commissioning systems that include the full range of engineering services.
Looking beyond today’s frontiers, Bintai Kinden is confident that it has the resources, technical expertise and progressive mindset to consolidate its position globally. The integration of research, management, marketing and sales that transcends organizational borders enables Bintai Kinden to capitalize on synergistic potential and benefits of scale.
On September 18, 2020, Generex Biotechnology Corporation and its majority owned subsidiary NuGenerex Immuno-Oncology, Inc., (collectively “Generex”) signed an agreement, called a Heads of Agreement, binding the August 14, 2020 memorandum of understanding (MOU) with Bintai Kinden Corporation of Malaysia (“Bintai”) for the development and commercialization of the Ii-Key-SARS-CoV-2 coronavirus vaccine (the “Agreement”). The Agreement, among other things, also expanded an understanding between Generex and Bintai (the “Parties”) related to the following:
1. Finalize and solidify the terms and conditions of the licensing agreement within TWO (2) weeks from the date of the Agreement, wherein the Parties will complete its perusal, clarify and finalization of the terms and conditions of the Agreement.
2. Parties agree to be bound by the terms from the original non-binding MOU and Parties are in legal process to effectuate and finalize the Contract Document.
3. Parties agree that Generex shall at all aspects procure all documentations, permits, consents, and approvals for the full approval of FDA for the said Vaccine.
4. As outlined in the MOU, Bintai will pay Generex the following fees:
a. $2,500,000 - Intellectual Properties “IP” Assignment Rights
b. $100,000 – Regulatory Fees
c. $25,000 – Legal Fees
d. $7,500,000 – Government of Malaysia Licensing Fees
e. $10,000,000 – Private Sector Licensing Fees
f. $3.00 Per Dose – Government of Malaysia Royalties Fees
g. $4.50 Per Dose - Private Sector Royalties Fees
This Current Report contains summaries of the material terms of the Agreement. The summary of the Agreement contained in this Current Report is subject to, and is qualified in its entirety by, reference to the Agreement, which is filed as an exhibit hereto and incorporated herein by reference.
A copy of the Agreement signed September 18, 2020, is filed as Exhibit 99.1 to this Current Report.
On September 18, 2020, Generex issued a press release announcing the Agreement with Bintai as described above, a copy of which is filed as Exhibit 99.2 to this Current Report.
A copy of the MOU signed August 14, 2020, is filed as Exhibit 99.3 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 Bintai Kinden
With over 40 years of specialist engineering and construction experience, Bintai’s unique combination of extensive regional experience and local knowledge has made them the region’s international contractor of choice. Headquartered in Malaysia, Bintai Kinden has expanded operations regionally throughout South-East Asia, China and the Arabian Gulf region.
As multi-disciplined, building and industrial service engineers and specialists, Bintai works in all the major market sectors, from commercial buildings to industrial complexes, designing, installing and commissioning systems that include the full range of engineering services.
Looking beyond today’s frontiers, Bintai Kinden is confident that it has the resources, technical expertise and progressive mindset to consolidate its position globally. The integration of research, management, marketing and sales that transcends organizational borders enables Bintai Kinden to capitalize on synergistic potential and benefits of scale.
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