Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 194

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 194
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 February 2029, or (ii) until the expiration of the last valid patent relating to Nolazol, subject to early
termination under certain circumstances. Pursuant to the terms of the EF License Agreement, we are responsible for obtaining
regulatory approval to market and commercialize Nolazol in the United States and Eurofarma was responsible for obtaining regulatory
approval in South America; provided, however, that Eurofarma would inform us of any additional information that regulators in Latin
America 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 us $2.5 million. In accordance with the EF License Agreement, we were 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, we entered
into a License Agreement with Novartis Pharma AG or Novartis, whereby we 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,
formulation data and know-how for all products containing mazindol as an active substance, and all post-marketing clinical studies and
periodic safety reports from 1973 onwards. Under the Agreement, we have obtained the same rights on a non-exclusive basis in all territories
outside of the U. S, except for Japan, with the right to cross-reference the 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, we agreed to pay Novartis $250,000 upon the signing of the agreement with milestone
payments due as follows: (i) $