Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 369

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 19
Chunk 369
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 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, the Company has 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, the Company paid Novartis $250,000upon 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, with the amount to be reduced to $375,000 if toxicology
studies must be repeated; (ii) $2 million following the earlier of U. S. Food and Drug Administration (“ 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 the Company’s product candidate reaching $250 million in cumulative sales.

Litigation

The Company may become involved in miscellaneous
litigation and legal actions, including product liability, consumer, commercial, tax and governmental matters, which can arise from time
to time in the ordinary course of the Company’s business. Litigation and legal actions are inherently unpredictable, and excessive
verdicts can result in such situations.

On December 1, 2023, the Company received a
letter from Cambrex Corporation, stating that as of December 1, 2023, the Company has an overdue balance for services completed
under certain proposals by and between the Company, Cambrex High Point, Inc. and Avista Pharma Solutions, Inc. in the aggregate
amount of $492,723. On October 10, 2024, the Company successfully settled the outstanding claim through a debt purchase agreement
with an accredited investor, in the amount of $200,013, which effectively resolved the creditor claim.

On August 21, 2024, the Company received a letter
from Dunn Lambert LLC, the law firm representing Clinilabs, Inc., or