Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 225

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 225
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 and allocations for
severance pay.

While none of Kadimastem’s
employees are party to any collective bargaining agreements, certain provisions of the collective bargaining agreements between the Histadrut
(General Federation of Labor in Israel) and the Coordination Bureau of Economic Organizations (including the Industrialists’ Associations)
are applicable to Kadimastem employees by extension orders issued by the Israel Ministry of Economy (previously the Israeli Ministry
of Trade, Industry and Labor). These provisions primarily concern the length of the workweek, pension fund benefits for all employees
and for employees in the industry section, insurance for work-related accidents, travel expenses reimbursement, holiday leave, convalescent
payments and entitlement for vacation days. Kadimastem generally provides its employees with benefits and working conditions beyond
the required minimums. Kadimastem has never experienced any employment-related work stoppages and believes its relationship with its
employees is good.

All of Kadimastem’s
employment and consulting agreements include employees’ and consultants’ undertakings with respect to non-competition and
assignment to Kadimastem of intellectual property rights developed in the course of employment and confidentiality. The enforceability
of such provisions is limited by Israeli law.

Government Regulation
and Product Approval

Governmental authorities
in the United States and in other countries extensively regulate, among other things, the research, development, testing, manufacture,
labeling, packaging, promotion, storage, advertising, distribution, marketing and export and import of products such as those Kadimastem
is developing. Any product candidate must be approved by the FDA through the NDA process before they may be legally marketed in the United States
and by the Committee on Human Medicinal Products, or CHMP, via the EMA and European Commission through the MAA process before they may
be legally marketed in Europe, or MHRA through its authorization procedures before they may be legally marketed in the UK. Any product
candidate will be subject to similar requirements in other countries prior to marketing in those countries. The process of obtaining
regulatory approvals and the subsequent compliance with applicable federal, state, local and foreign statutes and regulations require
the expenditure of substantial time and financial resources.

United States
Government Regulation

NDA Approval
Processes

In the United States,
the FDA regulates drugs under the FDCA and implementing regulations and guidance documents. Failure to comply with the applicable U. S. requirements
at any time during the product development process or approval process, or after approval, may subject