Licenses and Supply Agreements | 7. Licenses and Supply Agreements Forte Animal Health, Inc. On July 8, 2021, the Company amended the license agreement (the “Amended License Agreement”) with Forte Animal Health Inc. (“Forte”), a related party, dated February 27, 2020. Under the Amended License Agreement, the Company granted Forte an exclusive license to develop and commercialize pharmaceutical products consisting of Lodonal and MENK for use in veterinary applications for all indications world-wide. Milestone payments and royalties are defined in the agreement based on development and royalties are based on sales during the license period. The initial license fee included the assignment of certain Company defaulted notes and other vendor and employee obligations. During the second quarter of 2022, these debtors associated with the assigned obligations completed the assignment of $ 1,775,275 264,790 1,125,086 In connection with the amended license agreement, Forte issued 2,235,000 15 Forte has agreed to make payments to the Company in connection with this agreement as follows: ● Initial License Fee, upon the assignment of certain Company Notes Payable. ● Development Milestone Payments upon the occurrence of the identified events, one-time, non-creditable, non-refundable milestone payments of $ 100,000 ● Commercial Milestone Payments upon reaching the mutually agreed aggregate net sales. Forte will pay one-time, non-creditable, non-refundable milestone payments to be negotiated and addressed in a separate Amendment later. ● Royalties during the royalty term (generally 15 Schedule of Royalty Rate Annual Sales of Royalty Qualifying Licensed Products Royalty Rate <$500,000,000 2 % 500,000,000 to < $1,000,000,000 4 % > $1,000,000,000) 6 % Cytocom On May 13, 2020, the Company and Cytocom entered into an Amendment to The Second Amendment to The License Agreement (“Third Amendment”) that was effective December 31, 2018. The sublicense provides Cytocom with the Company’s previously licensed rights for LDN and MENK in Emerging Markets. Original terms for consideration for the sublicense were not finalized until August 12, 2020, at which time Cytocom and the Company signed a letter agreement in which Cytocom agreed to assume a combination of defaulted notes plus certain other liabilities. Such terms were amended, and the Company agreed to transfer all the rights, title, and interest to Cytocom in technology licensed from Penn State Research Foundation (“PSU”) in exchange for Cytocom assuming all past due and future obligations under the PSU license. While the Company formalized the agreement to assign all outstanding liabilities due to PSU, a vendor of the Company, PSU did not consent to the assignment of the payables to Cytocom. As of December 31, 2021, the Company had no outstanding accounts payable balances due to Penn State University. On July 20, 2021, Cytocom and the Company agreed to modify the terms of the original sublicense. The renegotiated terms are presented below. The assignment of the Notes and associated accrued interest and penalties in default was fully executed in the third quarter of 2020 with the transfer of the notes upon the creditors’ signoff. The Company recognized a gain upon the assignment of these notes in the third quarter of 2020. Cytocom has not completed the assumption of the remaining liabilities. Cytocom and the Company are actively engaged in negotiations to modify the terms of the original sublicense. Consideration for License to Cytocom as of December 31, 2022 Schedule of Consideration Consideration / Assumption of: Notes and associated accrued interest in default $ 3,302,209 Accounts payable and accruals 230,000 Past Due Employee Obligations 1,110,567 Total anticipated Consideration $ 4,642,776 Recognized through December 31, 2020 (3,302,209 ) To Be Recognized upon Execution $ 1,340,567 As of December 31, 2023, the Notes transaction has not been fully executed. The Notes in default have been assigned and the transfer signed off by the creditors, but Cytocom still has not completed the assumption of the agreed upon obligations. Until the transaction is completed Cytocom (Statera) does not have clear title and interest to the Immune technology. In March 2023, the Company and Cytocom negotiated an amendment to the licensing agreement (“Third License Amendment”) which has been submitted to the board of directors of Cytocom for approval. The Third License Amendment: ● Restates the licensing arrangement between the Company and Cytocom and grants the Company manufacturing, distribution and marketing rights for LDN and MENK, in humans for all indications except Crohn’s Disease (worldwide), and animals (US only). ● Grants the Company the right grant sublicenses to third parties for the manufacturing, distribution and marketing of these products. ● Updates the royalty rates as follows: Annual Sales of Royalty Qualifying Licensed Products Royalty Rate <$500,000,000 2 % 500,000,000 to < $1,000,000,000 4 % > $1,000,000,000) 6 % As of December 31, 2023, the Notes transaction and Third License Amendment have not been fully executed. The Notes in default have been assigned and the transfer signed off by the creditors, but Cytocom still has not completed the assumption of the agreed upon obligations. Until the transaction is completed, Cytocom (now, Statera Biopharma, Inc.) does not have a clear title and interest to our Company’s technology. TaiwanJ Pharmaceuticals Co. Ltd. On September 30, 2022, the Company entered into an Intellectual Property License Agreement (the “ Agreement TaiwanJ Products The Company also received a non-exclusive worldwide right to make, manufacture, and receive technical manufacturing assistance from TaiwanJ for the creation of the Products. The only territories excluded from the scope of the Agreement are any countries or territories in Asia, and any countries or territories barred or sanctioned by the United States government. We did not have any relationship with TaiwanJ prior to entering into the Agreement. The term of this Agreement is to be perpetual, but termination of the Agreement may occur upon (i) the Company providing sixty (60) days prior written notice to TaiwanJ of termination, (ii) termination of the agreement for a material breach of the agreement, and failure to cure that breach within ninety (90) days after receiving notice of such breach, (iii) the dissolution of the Company, or (iv) upon bankruptcy of either party, upon receiving sixty (60) days’ notice by Registered Mail. The Company may grant sublicenses under the Agreement. Upon the granting of any such sublicense, the Company will pay TaiwanJ royalties based on the stage of development of the Products. The Company will pay a royalty of 30 10 5 NDA Pursuant to the terms of the license in the Agreement, the Company shall adhere to a plan of development and attain certain milestones. As part of the Development Plan, the Company shall (i) use commercially reasonable efforts and cause its sublicenses to use commercially reasonable efforts to develop licensed Products, (ii) begin commercial sales of the Products in a country no less than eight (8) months after the first registration of the Products in that same country, and (iii) following commercialization, the Company must keep the Products reasonably available to the public. In consideration for the license, the Company will provide (i) a non-refundable cash payment of $500,000 within ninety (90) days of September 30, 2022, (ii) a non-refundable cash payment of $500,000 at the earliest of either the National Agency for Food and Drug Administration and Control (“ NAFDAC FDA The Company will be required to pay one-time payments and issuances of equity for the achievement of each of four milestones in the commercialization and development of the Products. In addition to the milestone payments, if there is any year that the Company is not required to pay a Milestone Payment, the Company will pay a royalty percentage payment based on the total net sales due within sixty (60) days after the end of each calendar quarter (the “ Royalty Payment If the Company fails to make any of the above-described payments upon their designated due date, the payment amount will bear the lower of (i) 1.5% interest per month or (ii) the maximum rate allowed by law, to be compounded quarterly. The interest will accrue beginning on the first day after the payment is due. TaiwanJ will maintain, protect, and defend all patent-related intellectual property and the Company will reimburse TaiwanJ for any expenses related to intellectual property patent payments that exclusively benefit the Company. If either the Company or TaiwanJ becomes aware of any possible or actual infringement of any patent rights, then each party will notify the other, and provide it with details of such an infringement. Both the Company and TaiwanJ are limited in liability to the total amounts paid under this Agreement for any damages arising from negligence, strict liability, or any other equitable theory. Further, both the Company and TaiwanJ agree to indemnify and hold harmless each other, and their respective agents, for any claims or costs arising from this Agreement or any sublicenses for any cause of action relating to any product, process, service made, used, or sold pursuant to this Agreement. On January 19, 2023, the Company’s board of directors voted to issue an additional 250,000 500,000 On March 26, 2023, the Company paid $ 150,000 On April 13, 2023, the Company issued a note payable to TaiwanJ in the amount of $ 250,000 100,000 18.0 matured on May 30, 2023 |