Company: NCEL
Filing Date: 2025-05-16
Form Type: 20-F
Source: 0001213900-25-044868
Chunk: 237

Company: NewcelX Ltd.
Filing Date: 2025-05-16
Form: 20-F
Item: Item 4
Chunk 237
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, enacted in 2010 as part of the Affordable Care Act, requires certain manufacturers of pharmaceuticals and medical devices
to annually report certain payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists
and chiropractors) and teaching hospitals, as well as investment interests held by physicians and their immediate family members. Effective
January 1, 2022, covered manufacturers will also be required to report on payments and other transfers of value to physician assistants,
nurse practitioners or clinical nurse specialists, anesthesiologist assistants, certified registered nurse anesthetists, and certified
nurse-midwives during the previous year. In recent years, several states in the United States have also enacted legislation
requiring pharmaceutical companies to file periodic reports with the state, make periodic public disclosures on sales, marketing, pricing,
clinical trials and other activities, and/or register their sales representatives, as well as establish marketing compliance programs.
These laws may affect Kadimastem’s sales, marketing, and other promotional activities by imposing administrative and compliance
burdens on us. Failure to meet these requirements, to the extent they are applicable to Kadimastem’s activities, could also result
in a variety of governmental sanctions that could have a material adverse effect on Kadimastem’s business.

If Kadimastem’s
operations are found to be in violation of any of the foregoing or other applicable health care laws and regulations, we may be subject
to penalties, including significant administrative, civil and criminal penalties, monetary damages, disgorgement, imprisonment, the curtailment
or restructuring of Kadimastem’s operations, loss of eligibility to obtain approvals from the FDA, or exclusion from participation
in government contracting, healthcare reimbursement or other government programs, including Medicare and Medicaid.

Other Countries

In addition to
regulations in the United States, the EU, the UK and Israel, Kadimastem is subject to a variety of other regulations governing
clinical trials and commercial sales and distribution of drugs in other countries. Whether or not a product candidate receive approval
from the FDA, approval of such product candidates must be obtained by the comparable regulatory authorities of countries other than the
United States before we can commence clinical trials or marketing of the product in those countries. The approval process varies
from jurisdiction to jurisdiction, and the time may be longer or shorter than that required for FDA approval. The requirements governing
the conduct of clinical trials and product licensing vary greatly from country to country