License Agreements | 6. License Agreements License Agreement with the National Institutes of Health The Company is a party to a non-exclusive patent license agreement (as amended, the “NIH Agreement”) with a U.S. government entity, the National Institutes of Health, represented by National Institute of Allergy and Infectious Disease (“NIAID”), which was originally entered into in June 2018. Under the NIH Agreement, the Company obtained a non-exclusive, worldwide, royalty-bearing, sublicensable license under certain NIAID patent rights, and transfer of know-how and biological materials for use in adjuvanted or non-adjuvanted vaccines for the prevention, cure, or treatment of RSV and metapneumovirus (hMPV) infection in humans. Under the NIH Agreement, the Company is required to use commercially reasonable efforts to meet certain specified development, sales and regulatory milestones related to the licensed products within specified time periods. In consideration of the rights granted to the Company under the NIH Agreement, the Company paid a licensing fee upon execution of the NIH Agreement of $ 100,000 , and will pay annual minimum royalty payments starting in the second year after the initial sale of each licensed product which can be credited against any earned royalties due for sales made in the year. The Company is obligated to pay aggregate potential milestone payments of up to $ 8.6 million with respect to future development and commercial milestones. Additionally, the Company has agreed to pay a tiered royalty of a low single digit percentage on net sales of all products applicable to the license. Additional royalties would be due in connection with sublicenses. The Company’s royalty obligations continue for each licensed product for so long as licensed patent rights exist and have not expired, been revoked, lapsed, or held unenforceable. The NIH Agreement will terminate upon the last expiration of the patent rights or the Company may terminate the entirety of the agreement upon discontinuation of development or sales of licensed products and provision of written notice thereof to NIH. The Company incurred no fees associated with the license during the three months ended March 31, 2023 and 2022. License Agreements with University of Washington License Agreement with respect to RSV and Other Pathogens The Company is a party to an exclusive license agreement with the University of Washington (“UW”), originally entered into in June 2018 (as amended, the “UW 2018 Agreement”). Under the UW 2018 Agreement, UW granted the Company an exclusive, worldwide, royalty-bearing, sublicensable license under certain UW patents to make, use, sell, offer to sell, import, and otherwise exploit any product covered by the licensed patents, or licensed products, for the prophylactic and/or therapeutic treatment of RSV infection, hMPV infection and eight other infectious diseases. UW also granted the Company a non-exclusive, worldwide license under certain know-how related to the licensed patents. The licensed patents and know-how generally relate to computationally designed nanoparticles and vaccines based upon such designs, and relate to the Company’s proprietary two-component virus-like-particle technology as well as certain one-component virus-like-particle technology. The Company’s rights and obligations under the UW 2018 Agreement are subject to certain U.S. government rights, certain global access commitment rights for humanitarian purposes to BMGF, certain rights to Howard Hughes Medical Institute ("HHMI"), and certain other limited rights retained by UW. The Company issued 192,276 shares of common stock on August 1, 2018 in exchange for the UW 2018 Agreement’s exclusive license. Under the UW 2018 Agreement, the Company is required to use commercially reasonable efforts to meet certain specified development, regulatory and sales milestones related to the licensed products within specified time periods. In consideration of the rights granted to the Company under the UW 2018 Agreement, the Company is required to pay an annual maintenance fee in the mid four figures starting in 2020. Additionally, the Company is required to pay minimum annual royalties following the first year after commercial sale of each licensed product. There are milestone payments due upon the completion of certain development, regulatory, and commercial milestones for licensed products in the future. The aggregate potential milestone payments for future development, regulatory, and sales-based milestones are $ 1.35 million per indication, up to a maximum of $ 12.2 million in total milestone payments. Additionally, the Company has agreed to pay a royalty of a low single digit percentage on net sales of all licensed products. Additional royalties would be due in connection with sublicenses. The Company’s royalty obligations continue for each licensed product for so long as licensed patent rights exist and have not expired, been revoked, lapsed, or held unenforceable. Unless terminated earlier, the UW 2018 Agreement will remain in effect until all licensed patent rights have terminated and all obligations due to UW have been fulfilled. The last-to-expire licensed patent, if issued, is expected to expire in 2042, subject to any adjustment or extension of patent term that may be available. UW can terminate the UW 2018 Agreement if the Company breaches or fails to perform one of its material duties under the UW 2018 Agreement and the Company is unable to remedy the default within an agreed upon time period that can be extended by UW. The Company may terminate the UW 2018 Agreement at will with prior written notice to UW. Option and License Agreement with Respect to COVID-19 The Company is also a party to an option and license agreement, originally entered into in July 2020 (as amended, the “UW 2020 Agreement”). Under the UW 2020 Agreement, UW granted the Company a non-exclusive, worldwide (excluding South Korea), sublicensable license under certain UW patents to make, use, sell, offer to sell, import, or otherwise exploit any product covered by the licensed patents for the prophylactic and/or therapeutic treatments of SARS-CoV-2 infection. Under an option exercised by the Company, UW granted the Company an exclusive license under the licensed patents for the United States, Canada, Mexico, and Europe (including Switzerland and the United Kingdom) starting in 2025. UW also granted the Company a non-exclusive, worldwide license under certain know-how related to the licensed patents. The licensed patents and know-how generally relate to computationally designed nanoparticles and vaccines based upon such designs. The Company’s rights and obligations under the UW 2020 Agreement are subject to certain U.S. government rights, certain global access commitment rights for humanitarian purposes to BMGF, certain rights to HHMI, and certain other limited rights retained by UW. Under the UW 2020 Agreement, the Company is required to use commercially reasonable efforts to meet certain specified development, regulatory and sales milestones related to the licensed products within specified time periods. The Company has agreed to pay a royalty of a low single digit percentage on net sales of all products applicable to the license. However, the Company will not be required to pay royalties on net sales of any licensed product under the UW 2020 Agreement if the Company is required to pay royalties on net sales under the UW 2018 Agreement. Additional royalties would be due in connection with sublicenses and milestones. The Company’s royalty obligations continue for each licensed product for so long as licensed patent rights exist and have not expired, been revoked, lapsed, or held unenforceable. Unless terminated earlier, the UW 2020 Agreement will remain in effect until all licensed patent rights have terminated and all obligations due to UW have been fulfilled. The last-to-expire licensed patent, if issued, is expected to expire in 2041, subject to any adjustment or extension of patent term that may be available. UW can terminate the UW 2020 Agreement if the Company breaches or fails to perform one of its material duties under the UW 2020 Agreement and the Company is unable to remedy the default within an agreed upon time period that can be extended by UW. The Company may terminate the UW 2020 Agreement at will with prior written notice to UW. During the three months ended March 31, 2023, the Company incurred a negligible amount of fees associated with the 2018 and 2020 Agreements, recorded as research and development expenses. During the three months ended March 31, 2022, the Company incurred a negligible amount of fees associated with the 2018 and 2020 Agreements. License Agreement with Respect to Influenza The Company is a party to a license agreement with UW ("UW Flu License Agreement") entered into in September 2021. Pursuant to the UW Flu License Agreement, UW granted the Company a non-exclusive, worldwide, royalty-bearing, sublicensable (subject to certain restrictions) license under certain UW patents to make, use, sell, offer to sell, import, and otherwise exploit any product covered by the licensed patents ("Licensed Flu Products"), for the prophylactic and/or therapeutic treatment of influenza. UW also granted the Company a non-exclusive, worldwide license to use certain know-how related to the licensed patents. The licensed patents and know-how generally relate to computationally designed nanoparticles and vaccines based upon such designs, and relate to the Company's proprietary two-component virus-like-particle technology and nanoparticle-based influenza virus vaccines. The United States federal government and HHMI have similar rights under the UW Flu License Agreement and the UW 2018 Agreement described above in “License Agreement with respect to RSV and Other Pathogens". The Company is obligated to use commercially reasonable efforts to commercialize Licensed Flu Products, and to initiate a clinical trial with respect to such Licensed Flu Products by a specified date in 2025. If the Company is unable to initiate a clinical trial by the specified date and cannot agree with UW to modify such obligation or does not cure by meeting such obligation, then UW may terminate the UW Flu License Agreement. Under the UW Flu License Agreement, the Company paid UW a one-time upfront license fee, and after September 2023 and for the remainder of the term of the UW Flu License Agreement, the Company is required to pay tiered minimum annual fees ranging from the mid four figures to the mid five figures, with such fees creditable against royalty payments. The Company is required to pay UW up to an aggregate of $ 6.4 million for payments related to development and commercial milestones. The Company is also required to pay UW a fixed, low single-digit percentage royalty on net sales of Licensed Flu Products by the Company and its sublicensees, subject to certain reductions if the Company is required to pay for third-party intellectual property rights in order to commercialize the Licensed Flu Products. The Company is not obligated to pay duplicate royalties on net sales of any Licensed Flu Products if the Company is already required to pay a royalty on such net sales under the UW 2018 Agreement and the UW 2020 Agreement. Unless terminated earlier, the UW Flu License Agreement will remain in effect until all licensed patent rights have expired and all obligations due to UW have been fulfilled. The last-to-expire licensed patent, if issued, is expected to expire in 2041, subject to any adjustment or extension of patent term that may be available. UW can terminate the UW Flu License Agreement if the Company breaches or fails to perform one of its material duties under the UW Flu License Agreement and is unable to remedy the default within an agreed upon time period that can be extended by UW. The Company can terminate the UW Flu License Agreement at will with prior written notice to UW. During the three months ended March 31, 2023 and 2022, the Company incurred a negligible amount of fees associated with the UW Flu License Agreement, recorded as research and development expenses. License Agreement with the University of Texas The Company is a party to an exclusive patent license agreement with the University of Texas at Austin (“UT”) with respect to its hMPV antigen utilized in the IVX-A12 program (the “UT Agreement”). The UT Agreement was entered into in June 2021. Under the UT Agreement, UT granted the Company an exclusive, worldwide, royalty-bearing, sublicensable license under certain patent rights, to use licensed know-how for prevention, cure, amelioration or treatment of respiratory disease caused by hMPV infection in all vaccine fields, excluding up to one mRNA-based vaccine. The Company is obligated to pay aggregate potential milestone payments of up to $ 4.6 million with respect to future development and commercial milestones. Unless terminated earlier, the UT Agreement will remain in effect until all the licensed patent rights have expired. The Company may terminate the UT Agreement with prior written notice to UT. UT may terminate the UT Agreement in whole or in part, or narrow the vaccine field, reduce the territory, or convert the license from exclusive to non-exclusive if the Company: (i) fails to meet its payment obligations, (ii) commits an uncured breach, (iii) commits three or more cured breaches within a specified time period, (iv) challenges the validity, enforceability, or scope of the licensed patent rights, or (v) undergoes certain insolvency-related events. During the three months ended March 31, 2023, the Company incurred no fees associated with the UT Agreement. During the three months ended March 31, 2022, the Company incurred a negligible amount in fees associated with the UT Agreement, recorded as research and development expenses. |