Commitments and Contingencies | Note 3 - Commitments and Contingencies: Commitments On July 7, 2020 we entered into an agreement with Ajinmoto 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. The estimated total payments required under this agreement are $243,900, including shipping and material estimates, of which Ajin has billed us $121,450 related to this agreement which is recognized as in research and development in our statement of operations for the year ended July 31, 2020. 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 NAABP achieving various milestones. The Company recognized $272,063 and $340,000 as research and development related to the clinical trial agreement with NSABP for the years ended July 31, 2020 and 2019 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. 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 NGIO (then Antigen Express), after which HJF continued trial management on behalf of NGIO. In consideration for the study the Company agreed to total compensation of $2,700,000 payable as follows: i. Initial payments of: a. $250,000 on February 1, 2007; and b. $250,000 on March 1, 2007 ii. Ongoing payments of $150,000 per quarter for three years beginning first quarter of 2007. iii. Final payments: $200,000 upon enrollment of the final subject and $200,000 upon completion of all subjects and receipt and acceptance of by the Company of all required documents. Upon written notice either party could terminate the agreement for insolvency or proceedings under bankruptcy law. The Company could Terminate the CSA without cause upon written notice to the Foundation. Although the Agreement has not been terminated, the Foundation has not provided the Company with a final clinical study report as required under the terms of the CSA. 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”) as further described below. 1) The Company agreed to pay the final $200,000 payment due upon completion of all subjects and acceptance by the Company of all documents, out of and a first charge any amounts received by the foundation or the Company from a third party in respect of or relating to the continued clinical development and commercialization of the breast cancer indication of the vaccine. 2) The Companies shall pay to the Foundation royalties in the following amounts based on the Companies' actual receipt of third party royalty payments in respect of Net Sales of the Vaccine as follows: a) to the extent that such third party royalty payments to the Companies are less than ten percent (10%) of third party Net Sales of the Vaccine (the "Level One Royalty), the Forbearance Payments to the Foundation will be an amount equal to fifty percent (50%) of the Level One Royalty; b) to the extent that such third party royalty payments to the Companies are equal to or greater than ten percent (10%) of third party Net Sales of the Vaccine, the Forbearance Payments to the Foundation will be an amount equal to five percent (5%) of third party Net Sales of the Vaccine; c) If, and to the extent that, the Companies directly engage in the marketing distribution, and sale of the Vaccine, the Forbearance Payments will be an amount equal to five percent (5%) of Net Sales of the Vaccine; and d) If third party royalty payments in respect of the commercialization of the Vaccine that are calculated other than with reference to Net Sales of the Vaccine, the Companies and the Foundation will revise the calculation methodologies in paragraphs (a) and (b) above to approximate the Forbearance Payments that would have otherwise been payable. 3) The Original Forbearance Amount will continue to accrue interest at one- and one-half percent (1.5%) per month. Once the Company has repaid the Original Forbearance Amount and interest through the royalty mechanism described above the Company may buy-out its continuing obligation to make Forbearance Payments my making the following payments: i. Period 1 (Effective date of the Forbearance Agreement through fifteenth month after the effective date of the Forbearance Agreement) buyout for $200,000 ii. Period 2 (First following the end of Period 1 through the twenty-fourth month after the effective date of the Forbearance Agreement) Buyout for $500,000 iii. Period 3 (the beginning of the third year following the effective date through the end of the fifth year following the effective date of the Forbearance Agreement) Buyout for $1,000,000 iv. Period 4 (any time after the beginning of the sixth year following the effective date of the Forbearance Agreement) Buyout for $2,000,000. The Company has not made any buy-out payments under the Forbearance Agreement. The Foundation may terminate the Forbearance Agreement, in its sole discretion upon giving written notice the Company of any of the following: i. If the Company fails to make a payment under the Forbearance Agreement (including interest) and fails to cure such nonpayment within thirty days after receiving written notice of such non-payment by the Foundation or; ii. if the Company is unable to repay its debts, makes a general assignment for the benefit of its creditors, has a petition in bankruptcy or a suit seeking reorganization, liquidation, dissolution, or similar relief filed against or files or permits the filing seeking relief under bankruptcy or; iii. the Company is in default in the performance of any of its obligations under the Forbearance Agreement and such default is not cured within thirty days after receiving written notice from the Foundation of such default. The Foundation has not notified the Company that it is in default of any of its obligations under the Forbearance Agreement. Effective August 1, 2015, the Company capitalized all outstanding unpaid interest on the outstanding balance. For the years ended July 31, 2020 and 2019, the Company recorded interest expense in the amount of $855,196 and $715,275, respectively, in the statements of operations. As of July 31, 2020, and 2019 the Company has recorded accrued interest of $3,911,141 and $3,055,945, 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. On behalf of the Company Generex paid expenses of $66,488 and $387,330 for the years ended July 31, 2020 and 2019, respectively. Certain shared expenses incurred by Generex, such as the shared corporate headquarters, have not been allocated to the Company as they are de minimus. |