Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits.
Exhibit
No.
|
Description
|
|
99.1
|
Heads
of Agreement signed September 18, 2020
|
|
99.2
|
Press
Release dated September 18, 2020
|
|
99.3
|
MOU
signed August 14, 2020
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|
DATED
THIS DAY OF 2020
BETWEEN
GENEREX
BIOTECHNOLOGY CORPORATION AND NUGENEREX IMMUNO-ONCOLOGY, INC. ("LICENSOR")
AND
BINTAI
KINDEN CORPORATION BERHAD (" LICENSEE")
HEADS
OF AGREEMENT
This
HEADS OF AGREEMENT (the"Agreement") effective as of the day of 2020
Between
Generex
Biotechnology Corporation and NuGenerex Immuno-Oncology, Inc. a wholly owned subsidiary of Generex Biotechnology Corporation,
each a Delaware corporation with an office address of 10102 USA Today Way, Miramar, FL 33025 ("Licensor")
And
Bintai
Kinden Corporation Berhad, a company incorporated in Malaysia under the Companies Act 2016 and having its business address
at 3-2-8 Kompleks Kantonmen Prima, No. 698, Jalan Ipoh, 51200 Kuala Lumpur, Malaysia (hereinafter referred to as "Licensee").
["Licensor"
and "Licensee" may each be referred to herein individually as a "Party" and
collectively as the"Parties".]
RECITALS
|
1.
|
WHEREAS,
Parties have executed the Memorandum of Understanding on the 14.08.2020 to lay down
the preliminary understanding for arrangements for the collaboration between Parties
in the funding, launching and management of the synthetic peptide vaccine for SARS-CoV-2
(the"Vaccine").
|
|
2.
|
WHEREAS,
The Licensor had later furnished a copy of the licensing agreement to the Licensee
to carry out its due diligence and perusal of the same on the binding terms and conditions
for both Parties.
|
|
3.
|
WHEREAS,
Licensor is the owner of certain patent rights, other intellectual property rights,
know-how and other proprietary rights in the relating to licensed compounds and/or research
information as anticipated in the Vaccine;
|
|
4.
|
WHEREAS,
Licensor desires to grant to Licensee an exclusive license in the field in Malaysia
related to the said licensed compounds and research information, and also desires to
conduct independent research pertaining to licensed compounds and research information
to further develop such licensed compounds and research information.
|
|
5.
|
WHEREAS,
Licensor and Licensee wish to enter into the licensing agreement to enable Licensee
to further develop and commercialize licensed products that incorporate or use one or
more compounds within the licensed compounds and/or the research information, and to
enable Licensee to use and exploit in the field within MALAYSIA and SOUTH EAST
ASIA markets any information, technology or intellectual property that arises from
the independent research or that relates to licensed compounds or research information,
or that covers research inventions.
|
|
6.
|
WHEREAS,
Licensor and Licensee wish to enter into the licensing agreement to enable Licensee
to have the first right of refusal to further develop and commercialize
licensed products that incorporate or use one or more compounds within the licensed compounds
and/or the research information, and to enable Licensee to use and exploit in the field
within New Zealand, Australia and global HALAL markets any information, technology or
intellectual property that arises from the independent research or that relates to licensed
compounds or research information, or that covers research inventions.
|
NOW
THEREFORE, in consideration of the premises and mutual covenants set forth below and other good and valuable consideration,
the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:
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1.1
|
The
Parties represents that it had commenced its due diligence towards each Party and is
in the midst of completing the same. The Parties further undertake to finalize and solidify
the terms and conditions of the licensing agreement within TWO (2) weeks from
the date of this Agreement, wherein the Parties will complete its perusal, clarify and
finalization of the terms and conditions of the Agreement.
|
|
1.2
|
Without
limiting the generality of the foregoing, the Licensee (itself or through its affiliates
and/or sublicensees), as stated in the Memorandum of Understanding executed on the 14.8.2020,
make payable a sum of USD $2 million to the Licensor. Parties agree to be bound by the
terms from the original non-binding Memorandum of Understanding and Parties are in legal
process to effectuate and finalize the Contract Document.
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1.3
|
Parties
agree that the Licensor shall at all aspects procure all documentations, permits, consents
and approvals for the full approval of FDA for the said Vaccine.
|
Parties
undertake that they shall treat as strictly confidential all information received or obtained by them or their officers, employees,
agents or advisers as a result of entering into or performing this Agreement including information relating to the provisions
of this Agreement, the negotiations leading up to this Agreement, the subject matter of this Agreement and the business or affairs
of the Parties that they will not at any time hereafter make use of or disclose or divulge to any person any such information
and shall use their best endeavours to prevent the publication or disclosure of any such information.
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3.
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CHOICE
_OF _GOVERNING LAW AND DISPUTE RESOLUTION
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This
Agreement shall be governed, construed, interpreted, in accordance with the Laws of Malaysia and subject to the exclusive jurisdiction
of the courts in Malaysia.
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4.
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REPRESENTATIONS
AND WARRANTIES
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4.1
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Each
Party hereby represents and warrants to the other Party as follows:
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(i)
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it
is duly incorporated and validly existing under the laws of the place of its incorporation;
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(ii)
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it
has the requisite power, authority and approval required to enter into this Agreement
and will have all requisite power, authority and approval to duly perform each of its
obligations hereunder;
|
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(iii)
|
its
execution, delivery and performance of this Agreement and any other agreements and documents
contemplated hereunder will not violate any of its constitutional documents, any other
agreement or obligation of such Party, any judgment or arbitral award binding on such
Party, or any currently effective law, regulation or decree of the jurisdiction in which
it is incorporated, that may be applicable to any aspect of the transactions contemplated
hereunder.
|
******
THIS SPACE IS INTENTIONALLY LEFT BLANK******
IN
WITNESS WHEREOF, the Parties hereto have executed this Agreement by and through their duly authorized representatives as of the
Effective Date.
For
and on behalf of
Generex
Biotechnology Corporation
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Name:
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Passport
No.:
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Designation
|
Witnessed
by
For
and on behalf of
NuGenerex
Immuno-Oncology
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Name:
|
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Passport
No.:
|
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Designation
|
Witnessed
by
Name:
Passport
No.:
For
and on behalf of
Bintai
Kinden Corporation Berhad (Company No. 290870-P)
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/s/
Ong Choon Lui
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Name:
ONG CHOON LUI
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Designation:
Group Managing Director Chief Executive Officer
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Witnessed
by:
/s/
Ng Yai Yee
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Name:
NG LAI YEE
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Identity
Card No.:
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IN
WITNESS WHEREOF, the Parties hereto have executed this Agreement by and through their
duly authorized representatives as of the Effective Date.
For
and on behalf of
Generex
Biotechnology Corporation
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/s/
Joseph Moscato
|
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Name:
Joseph Moscato
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Passport
No.:
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Designation:
CEO/President
|
Witnessed
by
For
and on behalf of
NuGenerex
Immuno-Oncology
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/s/
Michael Caridi
|
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Name:
Michael Caridi
|
|
Passport
No.:
|
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Designation:
Witness
|
Witnessed
by
Name:
Passport
No.:
For
and on behalf of
Bintai
Kinden Corporation Berhad (Company No. 290870-P)
Witnessed
by:
Source:
Generex Biotechnology Corporation September 18, 2020 09:00 ET
Generex
Signs Binding Licensing &
Research
Agreement with Bintai Kinden to Advance the Clinical Development & Commercialization of Ii-Key-SARS-CoV-2 Coronavirus Vaccine
for Malaysia
•
|
|
Bintai
Kinden Corporation Berhad (www.bintai.com.my) is an investment holding company headquartered
in Malaysia with operations throughout South-East Asia, China, and the Arabian Gulf Region
|
•
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|
Upfront
licensing fee of $2.5 million
|
•
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|
100%
funding for development, manufacturing and commercial registration of Ii-Key- SARS-CoV-2
prophylactic vaccine against COVID-19 in Malaysia
|
•
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Milestone
payments totaling $17.5 million upon approval by Malaysian Ministry of Health Contracted
royalty of $3 - $4.50 per dose of vaccine
|
•
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Potential
$150 million in GNBT revenues for vaccine sales in Malaysia
|
•
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Potential
to expand the partnership and development agreement in Australia, New Zealand, and the
global HALAL markets
|
MIRAMAR,
Fla., Sept. 18, 2020 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (http://www.otcmarkets.com/stock/GNBT/quote)
is pleased to announce that the company and Bintai Kinden Corporation of Malaysia have signed an addendum binding the terms of
the previously signed Memorandum of Understanding for the development and commercialization of the Ii-Key-SARS-CoV-2 coronavirus
vaccine.
Under
the terms of the Addendum, Bintai and Generex will finalize the legal and contractual documentation for the contract, partnership,
and licensing & research agreement, and Bintai will pay Generex an up-front licensing fee of $2.5 million within two weeks.
Additionally, Bintai will pay 100% of the funding required for the commercial development 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 Malaysia. Also, upon approval of the Ii-Key-CoV-2 vaccine in Malaysia, Bintai will pay Generex a $17.5 million milestone payment
and Generex will earn royalties on sales of the vaccine equal to $3 per dose on government sales and $4.50 per dose in the private
sector. Further, under this new Addendum, Bintai will have the right of first refusal for the Ii-Key-SARS-CoV-2 vaccine in Australia,
New Zealand, and the global HALAL markets, particularly in Southeast Asia.
Under
terms of the deal, Generex and Bintai have agreed to collaborate and have developed a strategy towards the rapid development of
the Ii-Key-CoV-2 vaccine for Malaysia. As part of that strategy, Generex has identified a local CRO, Jigsaw Clinical Research
Solutions (https://www.jigsawclinical.com/), managed by U.S. industry veteran, Jeffrey Yablon who has decades of experience in
clinical development and regulatory affairs, and has established Jigsaw as the premier Malaysian CRO.
Generex
CEO, Joseph Moscato said, “We want to thank our partners at Bintai for their commitment to develop our Ii-Key-SARS-CoV-2
“Complete Vaccine” against COVID-19. Our Ii-Key vaccine platform has always been about activation of the cellular
immune system pathway via Ii-Key, which imparts long term memory through T-Helper cells. Our Ii-Key-SARS-CoV-2 vaccine strategy
combines the Ii-Key T-Cell response with B-Cell epitopes that activate the humoral (antibody) response to deliver a Complete Vaccine
for short and long-term protection from COVID-19. The Ii-Key platform has demonstrated that AE37, our Ii-Key-HER2 vaccine provides
long-term immune memory with cellular responses active for three years in prostate cancer1,
and statistically significant benefit in disease free survival for breast cancer patients with advanced disease and low HER2 expression2.
Immunologic memory is the key to providing a real solution for COVID-19.
With
this licensing and research agreement being finalized, we can unlock the true potential of the Ii-Key technology to provide a
safe and effective vaccine to stop the SARS-CoV-2 pandemic, and to provide the long-term immune system memory needed to protect
the population. Our plan is collaborative, combining
U.S.
and Malaysian operations to advance our Ii-Key vaccine through the clinical and regulatory process in Malaysia to eventually transfer
the manufacturing to Malaysia for local production, leveraging Bintai’s expertise in industrial engineering and construction.
We have initiated the blood screening program using convalescent blood and serum for COVID-19 recovered patients to select Ii-Key-SARS-CoV-2
epitopes that will comprise the final vaccine formulation, after which we will initiate GMP manufacturing for Ii-Key- SARS-CoV-2
vaccine clinical trial supply.”
Mr.
Moscato continued, “I would like to personally thank the Bintai organization for their belief in Generex and commitment
to develop a safe, effective, and universal vaccine against SARS-CoV-2 for the benefit of Malaysia, and we look forward to accelerating
our COVID-19 vaccine program together.”
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.
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.
References
1Perez
et al. Cancer Immunol Immunother (2013) 62: 1599-1608
2Brown
et al Breast Cancer Research and Treatment. 22 April 2020.
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
MEMORANDUM
OF UNDERSTANDING
BETWEEN
BINTAI
KINDEN CORPORATION BERHAD !Company Registration No. 199401005191 (290870-P), a public listed company incorporated in Malaysia
under the Companies Act 2016 and having its registered business address at 3-2-8, Kompleks Kantonmen Prima, No. 698, Jalan Ipoh,
51200 Kuala Lumpur, Malaysia (“Bintai”).
AND
NUGENEREX
IMMUNO-ONCOLOGY, a company incorporated in the United States of America and having its corresponding address at 10102 USA
Today Way, Suite 200 Miramar, FL 33025 ("Generex'').
["Bintai”
and "Generex' shall hereinafter be jointly referred to as "Parties" and each
a
"Party''.]
RECITALS
|
1.
|
Generex
had previously maintained a robust research and development effort for potentially pandemic
viruses avian flu (H5Nl), swine flu (HlNl), HIV and SARS, creating on-demand peptide
vaccines that have been extensively studied through human clinical trials.
|
|
2.
|
Bintai
is a public listed company, listed on the Main Market of Bursa Malaysia Securities Berhad
under the stock name of BINTAI and stock code of 6998.
|
|
3.
|
Parties
have intended to execute this MoU to lay down the preliminary understanding for arrangements
for the collaboration between Parties in the funding, launching and management of the
synthetic peptide vaccine for SARS-CoV-2 (the "Vaccine") (the
"Project:').
|
|
4.
|
This
MoU is not intended to be legally binding and no legal obligations or legal rights shall
arise between the Parties from the provisions of the MoU. Parties enter into this MoU
intending to honour all their obligations herein.
|
TERMS
AND CONDITIONS
|
1.0
|
"Government
Authorities'' means a body listed in one of the following sub categories of the
central government of Malaysia, including but not limited to the following:
|
|
(a)
|
Government
department such as the Ministry of Health ("MoH');
|
|
(b)
|
Non-ministerial
department; or
|
|
1.1
|
"Confidential
Information' means any information, however it is conveyed, relating to the business
affairs, including all know-how, trade secrets, business plan and other information of
a confidential nature (including, without limitation, all proprietary technical, industrial
and commercial information and techniques in whatever form held as paper, electrically
stored data, magnetic media film and microfilm or orally), (a) relating to the provisions
of this MoU and the transactions and arrangements contemplated herein, and (b) is
either marked confidential or by its nature intended to be exclusively for the knowledge
of the recipient alone;
|
|
1.2
|
"Intellectual
Property Rights' means any patent, copyright, rights in and to inventions, trademarks,
service marks, design rights, registered designs, know how, database rights, moral rights,
right in get-up, goodwill and the right to sue for passing-off, rights to use, and protect
the confidentiality of, confidential information, confidential formulae and applications
for any of the foregoing, patents, trademarks, industrial designs, copyright, database
rights, know-how, trade or business and other rights of a similar nature;
|
|
1.3
|
"Vaccine
Manufacturing'' means a programme of activities which:
|
|
(a)
|
Create
and deliver a coherent programme of high quality, issue-identifying vaccine that holds
promise for stopping pandemic viral outbreaks of SARS COV2-coronavirus pandemic;
|
|
(b)
|
Create
and deliver Vaccine that is shown to be safe, well-tolerated, effective and produces
the desired immunological response in handling the SARS COV2-coronavirus pandemic;
|
|
(c)
|
Develop
technologies and systems that is available for scale manufacturing in an epidemic or
pandemic situation;
|
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(d)
|
Develop
testing protocols to ensure the efficacy based on the database and/or live sampling pertains
to the application of the Vaccine and keep a detailed statistical record;
|
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2.
|
BACKGROUND
OF THE VACCINE AND NUGEN :X:
|
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. 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.
Generex
Biotechnology Corporation has been working to develop a peptide vaccine against the new coronavirus SARS-CoV-2 using the company's
proprietary and patented Ii-Key immune system activation technology. We have built our technology to assist third party groups
and government agencies in their evaluation of potential vaccines against this pandemic SARS-CoV-2 virus.
The
patented NuGenerex Immuno-Oncology (Formerly Antigen Express) Ii-Key technology uses synthetic peptides that mimic essential protein
regions from a virus that are chemically linked to the 4-amino acid Ii-Key to ensure robust immune system activation. In particular,
the Ii-Key ensures potent activation of CD4+ T cells, which in turn facilitates antibody production to ward off infection. This
Ii-Key modification can be applied to any protein fragment of any pathogen to increase the potency of immune stimulation.
Generex
is working with our partners at EpiVax who have identified such protein fragments or epitopes to generate Ii-Key-SARS 2 peptide
vaccines in collaboration with our peptide manufacturing partners. The peptides and Ii-Key are made from naturally occurring amino
acids, ensuring an excellent safety profile for Ii-Key peptide vaccines. 2
1
https:/ / www.globenewswire.com/ news-release / 2020 / 07 / 15
/ 20626 45 / 0 / en / Nu Generex Immu no-Oncology-Closes-50-Million-Financing-Facility.html
2
https://www.generex.com/cov id- l9
3
For more information, please visit Generex and NuGenerix website at https://www.generex.com/
|
3.
|
PURPOSE,
RELATIONSHIP OF THE PARTIES, SCOPE OF COLLABORATION
|
|
3.
|
1
Parties have agree to collaborate and had laid down the strategy towards the rapid development
of the Vaccine as follows:
|
|
(a)
|
Streamlining
Vaccine Development Process
|
To
simultaneously implement different stages of development and production, so vaccine can be developed at a faster rate. Generex
has invested a sigificant amount of capital and made contractual commitments for the early-stage research, manufacturing, regulatory
work, and ex-vivo and clinical study of its Ii-Key Peptide Vaccine for COVID- 19
. Additionally, Generex had developed a clinical trial program that will enable the development of the Ii-Key-SARS-CoV2 Peptide
Vaccine for COVID-19 such that wehave human safety and preliminary efficacy results within 5 months.
|
(b)
|
Creating
Clinical Trials Globally
|
The
development of a vaccine for COVID-19 should not be a race for high income countries, byhaving
clinical trials in as many countries would enable the best chance of finding a vaccine that is safe, effective and affordable
for everyone. With a multi-country approach, it is the Parties' goals to conduct as many clinical trials as possible to ensure
efficacy of the vaccine is generalizable or suited to the native patients and to further obtain commercial license for sale of
Ii-Key/ COVID-19 Peptide Vaccine from the Malaysia Ministry of Health.
|
(c)
|
Global
Manufacturing Capacity
|
Parties
agree that the Vaccine Manufacturing should serve not only as a vaccination program for each country, but also as an economic
stimulus as many countries shift their focus to rebuild their economies following
the inevitable economic shutdown as the battle of the global pandemic continues.
|
3.2
|
Parties
aim
to further collaborate with the Government of Malaysia
and hoping the latter would provide facilities and technical resources with technical
guidance and support from Bintai and Generex. Facilities will include a research lab
for Ii-Key Peptide Vaccine Synthesis Analysis,
In-Vivo Testing and subsequently adequate facilities for Phase I, II and II of
clinical trials. Parties are further considering the technology transfer regarding the
Ii-Key Peptide vaccine with the Govern
men t of Malaysia, with the prime objective
to provide documented evidence that the clinical trials along with the manufacturing
process intended for SARS-COV-2 vaccine are robust and effective in producing the Vaccine,
in compliance with the specifications, Good Manufacturing Practice ("GMP')
requirements and further taking into account the financial considerations.
|
|
3.3
|
The
Parties agree to co-operate with each other in the preparation for the Project, based
on the terms in this MoU. The Parties shall later enter into an Agreement to further
detail the role and obligations of Parties under the Project, in line with terms and
conditions of the event planning and and contract documents under the Project, subject
to the results of due diligence to be conducted on each other ("Contract
Document" ).
The Contract Document will encapsulate the intellectual property assignment
rights, regulatory fees and legal fees which shall be anticipated at later stage. The
proposed costs involved are stipulated herein in Annexure 1. Bintai is
agreeable to make available USD $2 million to Generex upon conclusion of the Contract
Document.
|
|
3.4
|
Nothing
contained herein is intended to create any partnership, agency, representative relationship
or any other separate legal and/or corporate
entity. Save and except what is stated herein, no Party has the right to represent the
other Party or to enter into any commitment on behalf of the other Party without the
prior written consent of that Party and each Party assures and declares that it will
not hold itself as having such authority. Each Party shall be solely responsible for
its employees, contractors, consultants and for the employees of such contractors and
consultants, unless they are jointly engaged by the Parties.
|
|
3.5
|
Neither
Party nor any of its representatives, employees or agents is or shall be authorized to
bind or represent the other Party in any respect unless expressly provided under this
MoU.
|
|
3.6
|
Neither
the Parties, any of its Affiliate(s), nor any of their respective directors, officers,
agents, shareholders or employees acting on behalf of the Parties or any Affiliate, has
taken and shall take any action that will is or would be in breach of any applicable
laws for the prevention of fraud, bribery, corruption, racketeering, money laundering
or terrorism, including but not limited to the Malaysian Anti-Money Laundering, Anti-Terrorism
Financing and Proceeds of Unlawful Activities Act (AMLA) 2001 or its equivalent based
on its jurisdiction. The company and/or any affiliate will not, have any of the company's
shareholders, directors, officers, agents
or employees acting on behalf of the company or any affiliate established or maintained
any unrecorded fund or asset for any purpose, or has made any false or artificial entries
on any of its books or records for any reason in the performance of the Project.
|
|
3.7
|
The
Parties shall give their reasonable assistance and contribution to the execution of Project
according to their respective roles as stipulated
in this MoU and shall use all reasonable endeavors to assist each other to secure the
award of Project. The Parties will promote the name and goodwill and take such reasonable
steps as may be necessary in the execution and/or performance of the Project.
|
|
4.1
|
This
MoU shall become effective upon the date first written above and shall remain valid till
termination due to the following :
|
|
I.
|
forthwith
by Bintai if there is non-conformance and/or non performance by Generex under the Project;
|
|
II.
|
if
the other party ceases or threatens to cease to carry on its business or if a receiver,
administrator or similar officer is appointed over all or part of the assets or undertaking
of the other party;
|
|
4.2
|
In
the event of termination of the MoU for any of the reasons stated in clause
|
4.1
above, except for the rights and obligations accrued to the Parties prior to such termination, no Party shall have any claim against
the other Party.
|
5.1
|
The
existence or the terms of this MoU, and all data or information of a confidential nature
(including, without limitation, all proprietary, technical, industrial, commercial, and
financial information, know-how, trade secrets, business plan, intellectual property
or other information of any type) in any form (whether written, magnetic, electronic
or otherwise) acquired under, or in connection with, this Agreement, or supplied by either
Party, and shall include all information pertaining to the Intellectual Property Rights
of each Party.
|
|
5.2
|
Parties
undertake that they shall treat as strictly confidential all information received or
obtained by them or their officers, employees, agents or advisers as a result of entering
into or performing this MoU including information relating to the provisions of this
MoU, the negotiations leading up to this MoU, the subject matter of this MoU and the
business or affairs of the Parties and subject to the provisions of Clause 6.3 that they
will not at any time hereafter make use of or disclose or divulge to any person any such
information and shall use their best endeavors to prevent the publication or disclosure
of any such information.
|
|
5.3
|
The
obligations undertaken hereto shall not apply to any information obtained, which is or
becomes published or is otherwise generally available to the public other than in consequence
of any act or omission of either of the Parties hereto, or which is required to be disclosed
pursuant to an order of a court, statutory authority, governmental agencies as per the
applicable law or which is independently developed by a party without any use of the
confidential information protected hereunder or which is already known to the party at
the time of its disclosure hereunder.
|
|
5.4
|
Throughout
the term of this MoU and for a period of three (3) year after its termination or expiry,
the Parties shall maintain strict confidentiality of the information/ data of either
Party that is disclosed to the other Party in writing and shall not disclose such confidential
information/ data to any third party without the prior written consent of the other Party.
Each Party may however disclose the confidential information to its employees, directors,
officers, subcontractors, financiers, consultants, advisors and those of its subsidiaries
and affiliates who have a need to know such information in connection with fulfilment
of their obligations under the MoU.
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6.1
The Parties ensure that the business related to the Project are in full compliance with/of all the laws, statute, ordinance, rule,
license, permit, authorization, directive, by-law, regulation, etc. of any government authority or agency and any amendments or
revisions thereto which may from time to time be in force, whether national, state, municipal, local or other government subdivision
or any other duly constituted Governmental Authorities or agency of Governmental Authorities as applicable in Malaysia.
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7.
|
CHOICE
OF GOVERNING LAW AND DISPUTE RESOLUTION
|
7.1
This MoU shall be governed, construed, interpreted, in accordance with the Laws of Malaysia and subject to the exclusive jurisdiction
of the courts in Malaysia.
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8.
|
REPRESENTATIONS
AND WARRANTIES
|
|
8.1
|
Each
Party hereby represents and warrants to the other Party as follows:
|
|
(i)
|
it
is duly incorporated and validly existing under the laws of the place of its incorporation;
|
|
(ii)
|
it
has the requisite power, authority and approval required to enter into this MoU and will
have all requisite power, authority and approval to duly perform each of its obligations
hereunder;
|
|
(iii)
|
its
execution, delivery and performance of this MoU and any other agreements and documents
contemplated hereunder will not violate any of its constitutional documents, any other
agreement or obligation of such Party, any judgment or arbitral award binding on such
Party, or any currently effective law, regulation or decree of the jurisdiction in which
it is incorporated, that may be applicable to any aspect of the transactions contemplated
hereunder;
|
|
(iv)
|
it
has disclosed in writing, all material information in its possession which may have a
material adverse effect on its ability to fully perform its obligations herein, or which
if disclosed to the other Party, could have a material effect on the other Party's willingness
to enter into this MoU, and none of the information provided by it to the other Party
contains any material statements which are false or misleading; and
|
|
(v)
|
no
lawsuit, arbitration, other legal or administrative proceeding, or governmental investigation
is pending, or to the best of its knowledge, threatened, against it that would affect
in any way its ability to enter into or perform this MoU.
|
9
.1 Each Party shall indemnify and hold harmless the other Party from any claims, proceedings,
actions taken against or any expenses, costs, penalties or any other liabilities imposed
upon or incurred by the other Party as a result of any misleading. For the avoidance
of doubt, neither Party shall be responsible for the other Party's indirect, special,
punitive or consequential losses, costs, expenses or liabilities, including loss of profit,
loss of use, loss of contracts and loss of production under the indemnity provided in
this MoU.
|
|
10.1
|
Any
notice or demand required or permitted under the terms of this MoU or required by statute,
law or regulation shall (unless otherwise provided) be in writing and in English and
shall be deemed to have been validly given to the Parties if delivered personally or
sent by E-mail or registered post to the respective Party at the address specified above
or such other address as the recipient may have notified to the other Party in writing
and if so given shall be deemed to have been received:
|
|
(a)
|
if
delivered by hand, upon receipt thereof;
|
|
(b)
|
if
sent by registered post, on the fifth (5th) Business Day after posting; or
|
|
(c)
|
if
sent by E-mail, immediately after successful transmission thereof,
|
but
if the delivery or receipt is on a day which is not a Business Day or is after 6.00pm it is deemed to be given at 9.00am on the
next Business Day.
|
11.1
|
In
this MoU, unless there is something in the subject matter or context inconsistent with
such construction or unless it is otherwise expressly provided:
|
|
(a)
|
a
reference to a statutory provision includes a reference to any modification, consolidation
or re-enactment thereof for the time being in force, and all regulations, statutory instruments
and orders made pursuant thereto;
|
|
(b)
|
words
denoting one gender include all other genders;
|
|
(c)
|
words
denoting the singular include the plural, and vice versa;
|
|
(d)
|
words
denoting persons include firms and corporations, and vice versa, and also includes their
respective heirs, personal representatives, successors in title or permitted assigns,
as the case may be;
|
|
(e)
|
any
expression, agreement, covenant, term, provision, stipulation or undertaking expressed
to be made by or on the part of two or more persons or parties is made by those persons
or parties jointly and severally;
|
|
(f)
|
words
and phrases, definitions of which are given under the statute of Malaysia, shall be construed
as having the meaning thereby attributed to them, but excluding any statutory modification
thereof not in force at the date of this MoU;
|
|
(g)
|
a
reference to a Recital, Clause or Schedule is a reference to the relevant recital, clause
and schedule of and to this MoU;
|
|
(h)
|
any
reference to "writing", or cognate expressions, includes a reference to any
communication effected by facsimile transmission or other comparable means;
|
|
(i)
|
any
reference to this MoU (including its Schedules), or any of the provisions thereof, includes
all amendments and modifications made to this MoU (and its Schedules) from time to time
in force;
|
(i)
if any period of time is specified from a given
day, or the day of a given act or event, it is to be calculated exclusive of that day;
|
(k)
|
if
any time period specified in this MoU ends on a day which is not a business day in Malaysia
(i.e. a day on which licensed commercial banks are open for business in Malaysia) then
that time period is to be deemed to only expire on the next business day;
|
|
(1)
|
any
reference to a day, week, or month or year is to that day, week, month or year in accordance
with the Gregorian calendar;
|
|
(m)
|
any
reference to any promise, representation, warranty, covenant or undertaking given or
provided by the Parties, are deemed to have been given or provided by the Parties jointly
and severally as a business entity
|
|
(n)
|
The
headings to the Clauses and Schedules do not affect the interpretation of this MoU.
|
|
(o)
|
No
rule of construction applies to the disadvantage of a Party because that Party or its
solicitor prepared this MoU or any part of
it.
|
|
(p)
|
Where
any obligation in this MoU is expressed to be undertaken or assumed by any Party, that
obligation is to be construed as requiring that Party to exercise all rights and powers
of control over the affairs of any other person which that Party is able to exercise
(whether directly or indirectly) in order to secure the performance of the obligation.
|
|
11.2
|
The
language of the MoU and any correspondences between the Parties shall be English.
|
|
11.3
|
No
modification or amendment to the MoU shall be valid
unless agreed in writing by all Parties.
|
|
11.4
|
This
MoU represents the preliminary understanding between the Parties relating to the subject
matter hereof and supersedes any and all previous understandings both written and oral
with respect to the subject matter hereof.
|
|
11.5
|
Any
provision of this MoU, which is prohibited or, unenforceable, shall be ineffective to
the extent of such prohibition or unenforceability without invalidating the remaining
provisions hereof and any such prohibition or unenforceability shall not invalidate or
render unenforceable the other provisions of this MoU.
|
ANNEXURE
1
FINANCIAL
CONSIDERATION
(
sums stipulated herein are for reference purposes only)
PRE-COMMERCIALIZATION-
CLINICAL TRIALS I, II AND III
Details
|
|
USD
($)
|
|
USD
: MYR (1:4.5)
|
Intellectual Properties "IP" Assignment
Rights
|
|
|
2,500,000
|
|
|
|
11,250,000
|
|
Development
Cost for Host-Country - Subject to Regulatory Audit
Comprising:
Lab Development, Equipment, Related Facilities, Human Capital, Critical Support &
Related Information
|
|
|
TBC
|
|
|
|
TBC
|
|
Regulatory
Fees
|
|
|
100,000.00
|
|
|
|
450,000.00
|
|
Legal
Fees
|
|
|
25,000.00
|
|
|
|
112,500.00
|
|
TOTAL CONSIDERATION (EXCLUDING
DEVELOPMENT )
|
|
|
2,625,000.00
|
|
|
|
11,812,500.00
|
|
COMMERCIALIZATION
Government
of Malaysia - First Right of Refusal
|
|
USD
($)
|
|
USD
: MYR (1:4.5)
|
Licensing
Fees
|
|
|
7,500,000.00
|
|
|
|
33,750,000.00
|
|
Royalties
to Generex - per dose Ii-Key SARS COV-2 Peptide Vaccine Product
|
|
|
3.00
|
|
|
|
10.50
|
|
Private
Sector
|
|
|
|
|
|
|
|
|
Licensing
Fees
|
|
|
10,000,000.00
|
|
|
|
45,000,000.00
|
|
Royalties
to Generex - per dose Ii-Key SARS COV-2 Peptide Vaccine Product
|
|
|
4.50
|
|
|
|
20.25
|
|
INTELLECTUAL
PROPERTIES ASSIGNMENT DESCRIPTION
|
INTELLECTUAL
PROPERTIES “IP” Assignment Rights
|