Commitments and Contingencies | Note 3 - Commitments and Contingencies: Commitments On November 20, 2018, the Company entered into a clinical trial agreement with NSABP Foundation, Inc. (“NSABP”) under which NSABP will conduct clinical research using the Company’s AE37 peptide immunotherapeutic vaccine in combination with pembrolizumab (Ketruda®) for the treatment of metastatic triple negative breast cancer. The Company has agreed to pay NSABP an amount not to exceed $2,118,461 based on NSABP achieving various milestones. The Company recognized $80,000 for the three and six months ended January 31, 2021 and $0 and $251,459 as research and development related to the clinical trial agreement with NSABP for the and 2020 respectively. The Clinical Trial Agreement terminates upon the completion of the obligations under such agreement. The Clinical Trial Agreement may be terminated by (i) any party if the authorization to conduct the Phase II clinical trial is revoked by the FDA; if the human and/or toxicology results support termination; safety concerns; if the manufacture of a drug used in the Phase II clinical trial has been exhausted or (ii) by NSABP if NGIO fails to pay NSABP an undisputed amount under the Clinical Trial Agreement. On July 7, 2020 we entered into an agreement with Ajinomoto Bio-Pharma Services (“Ajin”) under which Ajin will manufacture one cGMP batch of AE 37. We may cancel the agreement by providing Ajin written notice. If we cancel the project, we will be subject to cancellation fees and be required to reimburse Ajin’s unbilled costs prior to the effective date of the cancellation. Over the life of the agreement the Company has incurred $215,321 of expense from this commitment. The total expense incurred for this commitment related to the three and six months ending on January 31, 2021 were $89,391 and $93,891, respectively. On October 2, 2020, the Company entered into an agreement with Polypeptide Laboratories San Diego (PLSD) to provide services for individual studies and projects, which may include synthetic process development, chemical synthesis, analytical method development and analysis of peptides and any other services relating to chemistry services requested from the Company. The Company shall conduct research activities and pay Polypeptide Laboratories San Diego for fees, expenses, and pass-through costs in accordance with each work order. The Company has agreed to pay Polypeptide Laboratories San Diego an amount not to exceed $684,521 based on PLSD achieving various milestones. The Company recognized $513,390 as research and development expense related to the agreement with PLSD for the period ending January 31, 2021. On October 5, 2020, the Company and its parent Generex entered into a Distribution and Licensing Agreement (the “Bintai Agreement”) with Bintai Healthcare SDN BHD (“BHSB”), a subsidiary of Bintai Kinden Corporation Berhad of Malaysia (“Bintai”) for the exclusive rights to distribute, sell, develop and commercialize the Generex Ii-Key-SARS-CoV-2 coronavirus vaccine (the “Vaccine”) in Malaysia and South East Asia countries, with right of first refusal to commercialize the Vaccine within New Zealand, Australia and the Global Halal markets (the “Territory”). The Agreement, among other things, consists of Bintai providing 100% funding for U.S. clinical development, manufacturing, and commercial registration of the Vaccine for the Territory. Under the aforementioned agreement, BHSB will provide collectively the Company and Generex with the following: 1. Payments of $2,625,000 as follows for pre-commercial stage as follows: a. $2,000,000 upon the execution of the Bintai agreement. b. $625,000 prior to commercialization. 2. A payment of $10,000,000 upon commencement of commercialization. If the Vaccine does not reach commercialization and does not secure the necessary FDA approvals within 6 months or within an approved reasonable amount of time thereafter, from the execution of this agreement, BHSB will be repaid the initial $2,000,000 payment. During the period ending January 31, 2021 the Company entered a Letter of Understanding with Generex, which illustrated the following terms in relation to fee sharing, considering the Bintai Agreement: 1. The Company shall perform all applicable services, terms and conditions under the Agreement. 2. Generex shall pay the Company 90% of all fees derived from the Bintai Agreement. 3. Generex shall pay for the cost to get the Ii-Key Peptide Vaccine for COVID-19 completed or until NGIO is publicly listed on a national exchange, such as NASDAQ. All payments made by Generex related to this agreement shall be recorded as capital contributions to the Company, as the Company will not repay these. As of January 31, 2021 there have been $2,000,000 received in connection with this contract. The Company has recorded $1,800,000 as a due from parent with an offset to contract liability. On November 13, 2020, Generex, the Company, Beijing Youfeng International Consulting Co., Ltd (“Youfeng”), Chinese Centre for Disease Control and Prevention National Institute for Viral Disease Control and Prevention (the “Chinese CDC”) and Beijing Guoxin Haixiang Equity Investment Partnership (Limited Partnership) (“Guoxin” and together with Youfeng and the Chinese CDC, the “China Partners”) entered into the Ii-Key Innovative Vaccine Development Agreement (the “Covid Agreement”) to set up a joint research team and a joint entity in China (the “Joint Entity”) that shall jointly develop and industrialize the Vaccine in China. The Covid Agreement provides that the Company and Generex will provide the Joint Entity with (i) Ii-Key-SARS-CoV-2 technology; (ii) technical know-how; (iii) preclinical and clinical data and (iv) background material on the Ii-Key platform pertaining to its Ii-Key peptide vaccine technology (collectively, the “Covid Vaccine Technology”). Pursuant to the Covid Agreement, the Company and Generex provided the Joint Entity with a perpetual sole and exclusive license to use the Covid Vaccine Technology in China. The Company and Generex shall negotiate separately with the Joint Entity with respect to the sale of such technology in other countries outside of China. Under the Covid Agreement Guoxin will provide the funding for the clinical development, manufacturing and commercial registration of the Vaccine for China and the Joint Entity will provide Generex with the following: 1. Licensing Fee: $5,000,000 upfront non-refundable fee due upon the execution of the Agreement. 2. Royalty Fee: Once the Vaccine comes on to market for the first commercial sale, then the Joint Entity shall: a. Offer Generex 20% of the equity interests in the Joint Entity for no additional compensation; or b. Make cash payments to Generex in a price equal to $2 per dose for the COVID-19 vaccine. 3. Equity Distributions: the net profits of the Joint Entity shall be paid first to collectively the Company and Generex until the Company and Generex receives $20 million, then the China Partners will receive the next $80 million in net profits from the Joint Entity and thereafter the Company and Generex collectively on one hand and the China Partners on the other will receive net profits from the Joint Entity in accordance with their pro-rated equity interests. As of January 31, 2021 there have been no payments received under this contract. If the Vaccine fails in its clinical trials, the Company and Generex will compensate the Joint Entity through one of two methods: 1. The Company and Generex will grant the Joint Entity sole and exclusive use of its technology and related intellectual property in Excellagen for a license fee of $10 million less the $5 million paid to the Company and Generex pursuant to the Covid Agreement and the remaining $5 million will be paid to the Company and Generex following National Medical Products Administration (“NMPA”), (the Chinese health authority), approval; or 2. The Company and Generex will grant the Joint Entity with a sole and exclusive license for the whole Ii-Key platform which includes infectious diseases and cancer for a $50 million license fee less the $5 million license fee paid to Generex pursuant to the Covid Agreement. Also, on November 13, 2020, the Company and Generex and the China Partners entered into the Ii-Key Innovative Flu Vaccine Development Agreement (the “Swine Flu Agreement”). Pursuant to the Swine Flu Agreement, the parties agreed that upon the successful development of the flu vaccine and receipt of approval from NMPA for the product launch, the Joint Entity shall have a sole and exclusive world-wide license for swine flu and shall pay Generex a license fee of $2.5 million less certain costs estimated at $500,000. The Company and Generex revised the Work, Cost and Fee Sharing Agreement, whereby the parties agreed to split the consideration received under the Bintai Agreement, the Covid Agreement and the Swine Flu Agreement as follows: With respect to the COVID Vaccine Agreement and the Swine Flu Agreement or any agreements entered into among the Parent, the Subsidiary and the Chinese Partners: Any and all fees, royalties or other cash payments paid under such agreements shall be split 90%/10% between the Company and Generex, respectively; provided however • Any costs required to be borne by Generex under the such agreements shall be borne by Generex until the common stock of the Company is listed on a national exchange. the Company shall be the 100% owner of any equity consideration provided to Generex under such agreements; provided, however, that Generex shall be entitled to cash distributions paid on such equity in accordance with clause above. Payable to Foundation On February 1, 2007, the Company entered into a clinical study agreement (the “CSA”) with a Henry J. Jackson Foundation (“Foundation”) for two Phase II clinical trials to determine if a vaccine containing AE37 plus GM-CSF or another peptide vaccine compound (GP2) plus GM-CSF improved patient outcomes. The Foundation conducted the study, under the sponsorship of an institute affiliated with the United States Military until the IND #12229 was transferred to the Company (then Antigen Express), after which HJF continued trial management on behalf of the Company. In consideration for the study the Company agreed to total compensation of $2,700,000 at various intervals over the term of the agreement. On September 1, 2013 the Foundation and the Company entered into a forbearance agreement (the “Forbearance Agreement”) under which the Company acknowledged they were $1,315,817 in arrears in its payment and interest obligations to the Foundation under the CSA (the “Original Forbearance Amount”). Pursuant to the Forbearance Agreement, the Company and the Foundation in exchange for the Foundations deferring the Company’s overdue payments, future payments and interest, the Company agreed, among other things to pay the Foundation certain royalties and accelerated payments (“Forbearance Payments”). Effective August 1, 2015, the Company capitalized all outstanding unpaid interest on the outstanding balance. For the three and six months ended January 31, 2021, the Company recorded interest expense in the amount of $249,665 and $488,424, respectively, in the statements of operations. For the three and six months ended January 31, 2020, the Company recorded interest expense in the amount of and $208,817 and $408,512, respectively, in the statements of operations. As of January 31, 2021 and July 31, 2020 the Company has recorded accrued interest of $4,399,565 and $3,911,141, respectively. Related Party Expenses paid by Generex on behalf of the Company have been treated as capital contributions from Generex as Generex will not be reimbursed by the Company for these expenses. For the three and six month periods ended January 31, 2021, Generex paid expenses of $1,482,246 and $3,049,389, respectively. For the three and six month periods ended January 31, 2020, Generex paid expenses of $3,114 and $29,700, respectively. During the six months ending January 31, 2021 the Company has recorded deferred revenue and a receivable due from Parent of $1,800,000 due to Bintai agreement. COVID-19 The ongoing coronavirus outbreak at the beginning of 2020 has impacted various businesses throughout the world, including travel restrictions and the extended shutdown of certain businesses in impacted geographic regions. If the coronavirus outbreak situation should continue to worsen, we may experience disruptions to our business including, but not limited disruptions of our ongoing clinical trials and the operations of our partners. The extent to which the coronavirus impacts our operations or those of our third-party partners will depend on future developments, which are highly uncertain and cannot be predicted with confidence, including the duration of the outbreak, new information that may emerge concerning the severity of the coronavirus and the actions to contain the coronavirus or treat its impact, among others. Any such disruptions or losses we incur could have a material adverse effect on our financial results and our ability to conduct business as expected. |