Genenta Science S p A : Effectiveness of the Amended and Restated OSR License Agreement - Form 6-K

Effectiveness of the Amended and Restated OSR License Agreement

As previously disclosed in the Annual Report on Form 20-F for the fiscal year ended December 31, 2022 of Genenta Science S.p.A. ("we," "us" or "our"), we entered into an amended and restated license agreement with Ospedale San Raffaele S.r.l. ("OSR," and such amended and restated license agreement, the "A&R OSR License Agreement") in March 2023, which amended and restated the license agreement we originally entered into with OSR on December 15, 2014, as subsequently amended on March 16, 2017, February 1, 2019, December 23, 2020, September 28, 2021, January 22, 2022, September 29, 2022 and December 22, 2022 (the "Original OSR License Agreement"). The effectiveness of the A&R OSR License Agreement was subject to Italy's Law Decree No. 21 of March 15, 2012 (the so-called Italian "Golden Power" regulations), as subsequently amended and supplemented, and would not become effective until the applicable Italian governmental authority consented to the A&R OSR License Agreement. On April 20, 2023, such consent was received and the A&R OSR License Agreement became effective.

Pursuant to the terms of the A&R OSR License Agreement, OSR has granted us an exclusive, royalty-bearing, non-transferrable (except with the prior written consent of OSR), sublicensable, worldwide license, subject to certain retained rights, to (1) certain patents, patent applications and existing know-how for the use in the field(s) of Interferon (IFN) gene therapy by lentiviral based-HSPC gene transfer with respect to (a) any Solid Cancer Indication (including glioblastoma and solid liver cancer) and/or (b) any Lympho-Hematopoietic Indication for which we exercise an option (described below); and (2) certain gene therapy products (subject to certain specified exceptions related to replication competent viruses) developed during the license term for use in the aforementioned field(s) consisting of any lentivirals or other viral vectors regulated by miR126 and/or miR130 and/or other miRs with the same expression pattern as miR126 and miR130 in hematopoietic cells for the expression of IFN under the control of a Tie2 promoter. Lympho-Hematopoietic Indication means any indication related to lympho-hematopoietic malignancies and Solid Cancer Indication means any solid cancer indication (e.g., without limitation, breast, pancreas, colon cancer), with each affected human organ counting as a specific Solid Cancer Indication.

The rights retained by OSR, and extending to its affiliates, include the right to use the licensed technology for internal research within the field(s) of use, the right to use the licensed technology within the field(s) of use other than in relation to the licensed products, and the right to use the licensed technology for any use outside the field(s) of use, but subject to the options described below. In addition, we granted OSR a perpetual, worldwide, royalty-free, non-exclusive license to any improvement generated by us with respect to the licensed technology, to conduct internal research within the field(s) of use directly, or in or with the collaboration third parties; and, for any use outside the field(s) of use, in which case the license is sublicensable by OSR. Finally, the world-wide rights for the field(s) of use granted to us regarding the Lentigen know-how are non-exclusive and cannot be sublicensed due to a pre-existing nonexclusive sublicense to these rights between OSR and GlaxoSmithKline Intellectual Property Development Limited.

Pursuant to the A&R OSR License Agreement, we have an exclusive option exercisable until April 20, 2026 (the "OPI Option Period") to any OSR product improvements at no additional cost, which could be useful for the development and/or commercialization of licensed products in the field of use (the "OPI Option"). We also have an exclusive option exercisable until April 20, 2026 (the "LHI Option Period") to any Lympho-Hematopoietic Indication(s) to be included as part of the field of use, on an indication-by-indication basis, subject to the payment of specified option fees and milestone payments (the "LHI Option"). We have the right to extend the LHI Option Period twice for additional 12-month periods, subject to the payment of specified extension fees.

Prior to the effective date of the A&R OSR License Agreement, we paid OSR an upfront fee in amount equal to €250,000 pursuant to the Original OSR License Agreement. Pursuant to the A&R OSR License Agreement, as consideration, we agreed to pay OSR additional license fees equal to up to €875,000 in total, which are payable on April 20, 2023, December 31, 2023, and upon our entering into a sublicense agreement with a third party sublicensee (pursuant to which we are entitled to receive an upfront payment in an amount exceeding a specified threshold from such sublicensee) during the period between September 30, 2022 and April 20, 2028 (with most of these additional license fees being triggered upon our entering into such a sublicense agreement). In addition, we have agreed to pay OSR royalties on a single digit percentage of the net sales of each licensed product. The royalty may be reduced upon the introduction of generic competition or patent stacking, but in no event would the royalty be less than half of what it would have otherwise been, but for the generic competition or patent stacking. We also agreed to pay OSR a royalty of our net sublicensing income for each licensed product and to pay OSR certain milestone payments upon the achievement of certain milestone events, such as the initiation of different phases of clinical trials of a licensed product, market authorization application ("MAA") approval by a major market country, MAA approval in the United States, the first commercial sale of a licensed product in the United States and certain EU countries, and achievement of certain net sales levels.