Company: NCEL
Filing Date: 2025-07-29
Form Type: F-4/A
Source: 0001213900-25-068765
Chunk: 396

Company: NewcelX Ltd.
Filing Date: 2025-07-29
Form: F-4/A
Chunk 396
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 may require in order to seek marketing authorization which otherwise may not be required by the FDA, or the Supplemental U.S. Data. Upon the execution of the EF License Agreement, Eurofarma paid NLS $2.5 million. In accordance with the EF License Agreement, NLS was also entitled to receive milestone payments as well as royalties from Eurofarma. The EF License Agreement was terminated on August 28, 2024, effective as of September 30, 2024. It was mutually agreed that neither party has any claims against the other in relation to the Agreement or its termination. Consequently, the deferred revenues amounting to $2,500,000 was realized as of the termination date. License Agreement with Novartis On March 10, 2021, NLS entered into a License Agreement with Novartis Pharma AG or Novartis, whereby NLS obtained, on an exclusive basis in the U.S., all of the available data referred to and included in the original NDA for Sanorex ®(mazindol) submitted to the FDA in February 1972. The agreement encompasses all preclinical and clinical studies, data used for manufacturing including stability and other chemistry manufacturing and controls data, 193

formulation data and know -howfor all products containing mazindol as an active substance, and all post -marketingclinical studies and periodic safety reports from 1973 onwards. Under the Agreement, NLS has obtained the same rights on a non -exclusivebasis in all territories outside of the U.S, except for Japan, with the right to cross -referencethe Sanorex NDA with non -U.S. regulatory agencies in the licensed territories. The Agreement includes the right to sublicense or assign the license to third parties, subject to such third parties meeting certain obligations. As consideration for the license, NLS agreed to pay Novartis $250,000 upon the signing of the agreement with milestone payments due as follows: (i) $750,000 payable following the end of a Phase II meeting with the FDA and subject to the FDA’s review and feedback on the preclinical data from Novartis, with the amount to be reduced to $375,000 in case certain toxicology studies must be repeated; (ii) $2 million following the earlier of FDA marketing authorization of Quilience or Nolazol; (iii) 1% of any upfront and milestone payments, if any, from any sublicensees and (iv) $3 million as