UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549 FORM 8-K

CURRENT REPORT

Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): November 5, 2020

 

 

GENEREX BIOTECHNOLOGY CORPORATION

(Exact of registrant as specified in its charter)

 

DELAWARE 000-29169 98-0178636
State or other jurisdiction of incorporation Commission File Number IRS Employer Identification No.

 

10102 USA Today Way, Miramar, Florida 3302

(Address of principal executive offices) (Zip Code)

 

(416) 364-2551

(Registrant’s telephone number, including area code)

 

(Former name or former address, if changed since last report.)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company ☐

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13 (a) of the Exchange Act. ☐

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class Trading Symbol(s) Name of each exchange on which registered
N/A N/A N/A

 

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Item 8.01 Other Events.

 

On October 30, 2020, Generex Biotechnology Corporation and its majority owned subsidiary NuGenerex Immuno-Oncology, Inc., (collectively “Generex”) signed a Framework Agreement on Cooperative Development of Coronavirus Peptide Vaccine (the “Agreement”) with Beijing Youfeng International Consulting Co., Ltd, Chinese Centre for Disease Control and Prevention National Institute for Viral Disease Control and Prevention (NIVDC) and Beijing Guoxin Haixiang Equity Investment Partnership (Limited Partnership) (collectively referred to as “China Partners”) to jointly develop and industrialize the Generex Ii-Key-SARS-CoV-2 coronavirus peptide vaccine (the “Vaccine”) in the People’s Republic of China (“China”). The Agreement, among other things, consists of the China Partners providing 100% funding for the clinical development, manufacturing and commercial registration of the Vaccine for China and paying Generex fees that shall be negotiated and agreed upon in subsequent agreements.

 

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 October 30, 2020, is filed as Exhibit 99.1 to this Current Report.

 

On November 4, 2020, Generex issued a press release announcing the Agreement with the China Partners as described above, a copy of which is filed as Exhibit 99.2 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 Framework Agreement on Cooperative Development of Coronavirus Peptide Vaccine signed October 30, 2020
99.2 Press Release dated November 4, 2020

 

 

 

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SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

Date: November 5, 2020

 

 

GENEREX BIOTECHNOLOGY CORPORATION

 

/s/Joseph Moscato

By: Joseph Moscato, CEO, President

 

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Contract Date: 26th-Oct-2020

 

 

 

Framework Agreement on Cooperative Development of Coronavirus Peptide Vaccine

 

 Party A: Beijing Youfeng International Consulting Co., Ltd

Address: 1-806 Huirunyuan Jingtong Expy, Shilipu, Chaoyang, Beijing, China

Pary B: Generex Biotechnology Corporation NuGenerex Immuno-Oncology (a subsidiary of Generex)

10102 USA Today Way SUITE 200, Miramar, FL 33025 

Party C: Chinese Centre for Disease Control and Prevention National Institute for Viral Disease Control and Prevention(NIVDC)

Address: No. 155, Changbai Road, Changping District, Beijing

Party D: Beijing Guoxin Haixiang Equity Investment Paiinership (Limited Partnership) Address: Building 96-6 Ronghui Park, Linkong Economic Core Area, Shunyi District, Beijing

 

Peptide vaccines, also known as synthesized vaccines, are vaccines prepared by peptide synthesis technology according to the known or predicted amino acid sequence of a certain epitope in the pathogen antigen gene. The coronavirus peptide vaccine is currently an important direction of coronavirus vaccine research, and is listed by the World Health Organization as one of the important research and development directions of coronavirus vaccine. In order to jointly develop and industrialize the coronavirus peptide vaccine, in accordance with the "Contract Law of the People's Republic of China", "The Vaccine Management Law of the People's Republic of China" and other relevant laws and regulations, the four parties A, B, C, and D have negotiated On the basis of true and full expression of their wishes, in line with the principles of equality, voluntariness, cooperation and sharing, this framework agreement is signed, and the four parties will jointly abide by it.

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.

Generex Biotechnology Corporation is an integrated healthcare holding company (public company) with end-to-end solutions for patient-centric care from rapid diagnosis through the delivery of personalized therapies. Generex is building a new kind of healthcare company that extends beyond traditional models providing support to physicians in an MSO network, and ongoing relationships with patients to improve the patient experience and access to optimal care.

NuGenerex Immuno-Oncology, Inc. a wholly-owned subsidiary by Generex, is the complete Vaccine immunotherapy company (public company), fighting cancer and infectious disease with our platform which is focused on harnessing the power of the immune system with a pipeline of products developed using our internationally patented novel Ii-key technology.

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.

2. Cooperative contents

The four parties of A, B, C, and D cooperate in the development and industrialization of a coronavirus peptide vaccine. The research plan is formulated by the four parties and determined after consultation by the four parties, including but not limited to: coronavirus peptide vaccine clinical trials (preclinical research, phase I, phase II and phase III clinical research) sample testing, product transfer to production etc.

3. Task distribution

The four parties A, B, C, and D jointly set up a research team to regularly exchange research and development and industrialization progress, including:

Party A task

 

Organize teams to work together to develop and transfer to production of Party B's Ii-Key peptide vaccine technology in China as soon as possible, and organize teams to conduct product development, product transfer and management 

Party B task

Owns patents and technologies related to Ii-Key peptide vaccine technology, and is responsible for providing technology, clinical data, patents information and other exclusive rights to the teams. 

Party C Task 

Provide technical means and technical support for vaccine clinical sample testing and clinical trials, be responsible for technical identification, research and development, and provide technical support for subsequent vaccine immunological evaluation 

Party D task 

Provide the funds needed for the research and development of this project.

 

4. Funds allocation and use

 

The detailed fund needs and tasks for the project shall be negotiated separately by the four parties A, B, C and D.

 

5. Achievements Distribution

 

1. The intellectual property rights (including but not limited to patents, papers, technical standards, awards, etc.) generated from the cooperation of this project are shared by the four parties A, B, C and D. For papers and awards and other achievements, Party C has the first authorship right; for patents, technical standards, etc., the ranking order will be negotiated by the four parties based on the size of the contribution.

 

2. The achievements of this cooperation of the four parties of A, B, C, and D are given priority to meet the needs of the coronavirus prevention and control tasks. For industrialization of the project is led by the four parties of A, B, C, and D. The entity established for this project in the future owns the new product certificate and Product registration approval.

 

3. The Incomes after public listing for each party shall be agreed by the four parties A, B, C, and D after friendly negotiation and determined in writing. Where the economic benefits obtained through technical services or technology transfer to be negotiated by the four parties A, B, C, and D, a distribution plan and an agreement to be reached and determined in writing

 

6. Effective, change and termination of the agreement

 

1. For the matters not covered in this agreement, parties A, B, C, and D shall make separate agreements based on the principles of mutual benefit and friendly negotiation, and shall express them in the form of a memorandum or annex. Based on the progress of the project, on the basis of abiding by the principles of this framework agreement, the four parties may further agree on their rights and obligations, the transfer and transformation methods and distribution principles of the achievements, or to make technical adjustments to the direction of R & D and industrialization . 

2. The memorandum or attachment of this agreement has the same legal effect as this agreement

3. After the four parties of A, B, C, and D reach an agreement through negotiation, or due to force majeure, this agreement cannot be performed or is not necessary for continued performance, the agreement can be terminated or cancelled according to law.

 

4. Special agreement for unilateral termination of the contract: If one party violates the provisions of this agreement, the observant party has the right to issue a written correction notice to the breaching party. If the breaching party fails to make corrections within the time limit set by the observant party so that the purpose of the four-party contract cannot be realized, the observing party may issue a written notice of termination of the contract to the breaching party. After the agreement is terminated, the follow-up work that has not been carried out will not be carried out, and the carried out will cease. If the results have been achieved, they will be allocated or owned according to the agreement.

 

7. Others

The original and independent research and intellectual property rights of A, B, C, and D will continue to be owned by the original owner.

2. Party A, Party B, Party C, and Party D are required to keep confidential the information and materials provided by the partner. Neither party shall disclose the contents of this agreement to a third party without the permission of the partners.

3. Party A, Party B, Party C and Party D earnestly implement this framework agreement and subsequent specific project agreements (attachments) based on the principle of honesty and trustworthiness. In case of breach of contract, the breaching party shall bear corresponding legal liabilities in accordance with the provisions of laws and regulations or the specific project agreement (if any).

 

4. Disputes arising from this agreement shall be settled through friendly negotiation by the four parties of A, B, C and D. if the negotiation failed. In line with the original intention of jointly fighting the coronavirus epidemic, the four parties sought common ground while reserving differences and put aside the dispute for now. If the work under this agreement is completed, or after this agreement is terminated or terminated in accordance with the agreement, if the four parties still cannot resolve the dispute through negotiation, either party may bring a suit to the people's court with jurisdiction where the plaintiff's domicile is located.

5. There are 8 copies of this agreement, with each of the four parties A, B, C and D holding 2 copies, with the same legal effect.

 

(The following is the signed part, no text)

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Generex Announces the Signing of a Framework Agreement with The China CDC, Beijing Guoxin Haixiang Equity Investment Partnership and Beijing Youfeng International Consulting Co., Ltd on the Cooperative Development of Ii-Key Vaccines

• Framework agreement outlines structure for project contracts:

° Ii-Key Vaccine for COVID-19

° Ii-Key Vaccine for Swine Flu

° Ii-Key Platform for Cancer and Infectious Diseases

• Impending contract to establish a Cancer Research Institute in China

• Licensing Deal for Excellagen in China

• 100% funding for manufacturing, development and commercial registration of Ii-Key- SARS-CoV-2 vaccine against COVID-19 in and Ii-Key Swine Flu vaccine in China

MIRAMAR, Fla., Nov. 04, 2020 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (http://www.otcmarkets.com/stock/GNBT/quote) today announced that the company has signed a Framework Agreement with the China CDC, Beijing Guoxin Haixiang Equity Investment Partnership, and Beijing Youfeng International Consulting Co., Ltd for the development and commercialization of the Ii-Key-SARS-CoV-2 coronavirus vaccine in China. The Agreement outlines the roles and obligations of the partners to advance the development of Ii-Key vaccines for infectious diseases and cancer under separate contracts that are currently being finalized. A total of five contracts are contemplated under the partnership framework, including individual contracts for the Ii-Key COVID vaccine and an Ii-Key swine flu vaccine. Additionally, the framework outlines terms for an exclusive license in China for the Ii-Key vaccine platform, as well as the establishment of a national research institute to advance the Ii-Key platform for cancer and infectious diseases. Further, the framework includes a licensing agreement for Excellagen wound conforming gel matrix for the management of wounds in China. 

The 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 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. Beijing Guoxin Haixiang Equity Investment Partnership (Limited Partnership) is a limited partnership established to fund the research and development efforts of the partnership.

Under the terms of this agreement, Generex will receive up-front development fees and back-end licensing payments, and the partners will conduct the research and development and pay 100% of the funding required for the commercial approval of the Ii-Key-CoV-2 vaccine including laboratory work, manufacturing, regulatory filings and the clinical development program for regulatory approval of the vaccine in China. Additionally, upon approval of the Ii-Key-CoV-2 vaccine in China, Generex will earn royalties on sales of the vaccine with the potential for multi-billion-dollar revenues.

 

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 in a highly specific manner that can provide protective immunity with long-lasting immunologic memory against SARS-CoV-2 and other pandemic threats like swine flu.

 

Generex CEO, Joseph Moscato said, “We are excited and proud to have the Chinese CDC, Youfeng, and Gouxin as partners to develop our Ii-Key-SARS-CoV-2 vaccine against COVID-19. Our partners in China understand the science and the power of the Ii-Key technology for the regulation of the immune system to develop safe and effective vaccines for infectious disease and cancer, and with this agreement, we cement our partnership to realize the full potential of our Ii-Key vaccine technology. In the coming days, we expect to finalize the impending contracts for the development of Ii-Key vaccines for COVID-19 and swine flu. We are also very enthusiastic about our plan to establish the cancer & infectious disease research institute in China to develop the Ii-Key platform as part of a national pandemic preparedness program as well as for the immunotherapy of cancer. We will own a stake in the research institute and earn royalties on any products that emerge from our collaborative efforts. We also expect to close a licensing deal for Excellagen® in which we will receive an upfront payment and royalties on sales of our novel and patented product for wound management.”

 

Mr. Moscato continued, “I would like to personally thank our partners at the China CDC, Youfeng, and Gouxin for their commitment and funding to develop a safe, effective, and universal vaccine against COVID-19. And with a contract to establish a research institute with our partners to advance the Ii-Key technology as the platform for pandemic vaccine development in China, we are perfectly positioned in the region where dangerous viruses emerge, enabling us in our work to stop pandemic threats at their source with the rapid development of Ii-Key Complete Vaccines. As we continue to execute on our Ii-Key vaccine development plans and China initiatives, we will provide our shareholders with updates as the individual project contracts are finalized and initiated. This is probably the biggest deal Generex could even imagine and we are all too happy to be partners with these acclaimed institutions to help China and the world.”

 

About Generex Biotechnology Corp.

 


Generex Biotechnology is an integrated healthcare holding company with end-to-end solutions for patient centric care from rapid diagnosis through delivery of personalized therapies. Generex is building a new kind of healthcare company that extends beyond traditional models providing support to physicians in an MSO network, and ongoing relationships with patients to improve the patient experience and access to optimal care.

 

About NuGenerex Immuno-Oncology

 


NuGenerex Immuno-Oncology, a subsidiary of Generex Biotechnology, is a clinical stage oncology company developing immunotherapeutic peptide vaccines for cancer and infectious disease based on the CD4 T-Cell activation platform, Ii-Key. NuGenerex Immuno-Oncology (NGIO) has been spun out of Generex as a separate public company to advance the platform Ii-Key technology, particularly in combination with the immune checkpoint inhibitors for the treatment of cancer. NGIO is currently engaged in a Phase II clinical trial of its lead cancer immunotherapeutic vaccine AE37 in combination with pembrolizumab (Merck’s Keytruda®) for the treatment of triple negative breast cancer. The company has also turned its Ii-Key technology on infectious disease, responding to the coronavirus pandemic with a SARS-CoV-2 vaccine development program.

 

Cautionary Note Regarding Forward-Looking Statements

This release and oral statements made from time to time by Generex representatives in respect of the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plan," "believes," "will," "achieve," "anticipate," "would," "should," "subject to" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties 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 claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

Generex Contact:

Generex Biotechnology Corporation

Joseph Moscato
646-599-6222

Todd Falls
1-800-391-6755 Extension 222
investor@generex.com