Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 195

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 195
---
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 a one-time payment upon our product candidate reaching $250 million
in cumulative sales.

Intellectual Property

We have developed a
robust patent portfolio of over 100 patents in over 14 countries including the United States, Canada, Australia, China and Japan,
and other European and Latin American countries. Our patent portfolio for Quilience and Nolazol currently includes issued patents in
the United States and Europe covering the use of mazindol for treatment of ADHD and patent applications filed in major countries to
protect our proprietary controlled release formulation (Notice of Allowance recently received for Europe and Canada) for treatment
of ADHD and narcolepsy. Mazindol ER has been grated a formulation patent in the United States, European Union and other countries,
providing protection through March 2037. One of our patents in the United States covering the use of mazindol for the treatment of
ADHD received patent term adjustment, thereby extending the patent term of such patent to August 2028. Additionally, we received
patent approval in Hong Kong covering the use of mazindol for the treatment of ADHD. This patent is expected to expire no earlier
than 2037. We have successfully launched NPP and secured additional patent grants, that coupled with successfully entering into
other expedited development programs, could allow Quilience to reach the market and patients sooner. This further supports our
global strategy with key patents granted the following major markets: Hong Kong, Japan, South Korea, the U. S., Europe & Canada.
Such patents pertain to technology, mechanism of action and application for: (i) sleep disorders, including narcolepsy, idiopathic
hypersomnia and Kleine-Levin syndrome, (ii) ADHD, (iii) neurodegenerative diseases including Lewy body disease, Parkinson’s
and Alzheimer’s, and (iv) treatment of CNS indications associated with sleep disorders.

The following table provides
a description of our