In November 2020, Generex Biotechnology announced that their Ii-Key COVID-19 vaccine development partner Bintai Kinden Corporation have executed their exclusive option to license and distribute the Ii-Key-SARS-CoV-2 vaccine in Australia and New Zealand once the vaccine is developed and approved by the FDA and relevant Malaysian authorities. NuGenerex Immuno-Oncology, in October 2020, closed its licensing & distribution agreement with Bintai Kinden Corporation of Malaysia for the development and commercialisation of the Ii-Key-SARS-CoV-2 coronavirus vaccine. Under the terms of the agreement, Bintai will have an exclusive license to distribute the Ii-Key-SARS-CoV-2 vaccine in Southeast Asia, including Malaysia, Vietnam, Indonesia, and the Philippines. Additionally, Bintai has been given an option, with right of first refusal for distribution in Australia and New Zealand using its extensive connections to secure contracts in the region.In exchange for the license and distribution exclusivity, Bintai has paid an up-front licensing fee of $US2.625 million and has committed to funding 100% of the commercial development costs for the Ii-Key-CoV-2 vaccine including laboratory and pre-clinical work, GMP manufacturing in the US, and global phase I, phase II, and phase III clinical trials, and all clinical and regulatory work required for approval in each of the licensed Australasian countries. Earlier, in August 2020, Generex Biotechnology signed a memorandum of understanding (MOU) with Bintai Kinden Corporation of Malaysia for the development and commercialisation of the Ii-Key SARS-CoV-2 coronavirus vaccine of Generex. Bintai agreed to pay Generex upfront development fees and back-end licensing payments, and will pay 100% of the funding required for the commercial development of the vaccine. The development activities will include laboratory work, manufacturing, regulatory filings and the clinical development program for regulatory approval of the vaccine in Malaysia. In addition, upon approval of the vaccine in Malaysia, Generex will receive royalties on sales of the vaccine with potential revenues of up to $US150 million. Under terms of the MOU, Generex and Bintai agreed to collaborate and develop strategy with primary goals including streamlining of vaccine development process, conducting clinical trials globally and building global manufacturing capacity. Later, in September 2020, Generex Biotechnology and Bintai Kinden Corporation of Malaysia signed an addendum binding the terms of the previously signed MOU for the development and commercialisation of the Ii-Key SARS-CoV-2 coronavirus vaccine. Under the terms of the Addendum, Bintai and Generex will finalise the legal and contractual documentation for the contract, partnership, and licensing & research agreement, and Bintai will pay Generex an up-front licensing fee of $US2.5 million within two weeks. Additionally, Bintai will pay 100% of the funding required for the commercial development of the vaccine in Malaysia. Also, upon approval of the vaccine in Malaysia, Bintai will pay Generex a $US17.5 million milestone payment and Generex will earn royalties on sales of the vaccine equal to $US3 per dose on government sales and $US4.50 per dose in the private sector. Further, under this new Addendum, Bintai will have the right of first refusal for the vaccine in Australia, New Zealand, and the global HALAL markets, particularly in Southeast Asia. [2] [3] [4] [5]
In November 2020, Generex Biotechnology Corporation closes its a licensing agreement with consortium of partners in China including Beijing Guoxin Haixiang Equity Investment, and Beijing Youfeng International Consulting for the development and commercialisation of the (Ii-Key-SARS-CoV-2) coronavirus vaccine in China. Under the terms of the deal, Generex will receive a licensing fee of up to $US50 million for the exclusive use of the Ii-Key vaccine platform for infectious disease and cancer in China and its territories. For each product developed using the Ii-Key technology under the platform license, Generex will receive an upfront payment, full funding for product development, regulatory approval, and commercialisation in China, a success fee upon product approval, and a royalty to be determined on a case-by-case basis [6] [7]
In March 2020, Generex Biotechnology entered into a licensing agreement with Beijing Zhonghua Investment Fund Management and Sinotek-Advocates International Industry Development for the development of coronavirus vaccine (COVID-19 strain), using the Ii-Key peptide vaccine platform of NuGenerex immune-Oncology (NGIO), a Generex’s majority owned subsidiary. According to the terms of the agreement Ii-Key peptides linked with nCOV-2019 coronavirus epitopes will be generated by Generex Biotechnology through NGIO and will be tested against the blood samples of the patients in China recovered from coronavirus infection by the Chinese partners. The data obtained will indicate the Ii-Key-nCOV epitopes recognised by the human immune system, that will eventually be developed as the potential coronavirus vaccine by Generex Biotechnology. The human clinical trials will be conducted in China and the USA. The Chinese partners will have exclusive rights to use and commercialise the products in China and will make payments to Generex Biotechnology that include upfront payment of USD$ 1 million, development expenses, royalty on each dose of vaccine produced and $USD 5 million as a licensing fee for the Ii-Key technology upon completion of development and testing. Generex Biotechnology will may payments to NuGenerex Immuno-Oncology after the receipt of the licensing payments, since the intellectual property resides with the later. [8]
In August 2019, Generex Biotechnology announced for a planned spin-out of its subsidiary NuGenerex Immuno-Oncology (formerly Antigen Express), which will include the Ii-Key technology and AE37 immunotherapeutic vaccine program. Based on this spin-out, NuGenerex Immuno-Oncology will separate and work as a public company. [9]
