Company: DRTSW
Filing Date: 2025-03-12
Form Type: 20-F
Source: 0001213900-25-023187
Chunk: 177

Company: Alpha Tau Medical Ltd.
Filing Date: 2025-03-12
Form: 20-F
Item: Item 4
Chunk 177
---
, the
approval holder is required to nominate an officer in charge of the medical device matters who shall bear overall responsibilities for
compliance, as well as a qualified individual who supervises the operational issues of safety and efficacy of the medical device it distributes.
The law also requires the approval holder to organize the compliance structure and allocate and document necessary responsibilities among
its staff.

Another major change from
the previous law is the introduction of a regulatory surcharge designed to strip the companies of the profits they gain from “false
or excessive” advertisement or promotion. The amount of the surcharge will be 4.5 percent of the sales volume of the particular
product it unlawfully promoted.

Promotional incentives to
the HCPs are governed by the industry association in the form of a fair competition code. For example, the prices of meals offered to
the HCPs may not exceed the ceiling under the code.

Advertisement is subject to
detailed regulatory guidance of the MHLW. Notably, it is not permitted to distribute academic publication articles to the HCPs when the
product is yet to be approved in Japan.

Other U. S. Regulatory Requirements

Medical device and pharmaceutical
companies are subject to additional healthcare regulation and enforcement by the federal government and by authorities in the states in
which they conduct their business and may constrain the financial arrangements and relationships through which we research, as well as
sell, market and distribute any products for which we obtain marketing authorization. Such laws include, without limitation, state and
federal anti-kickback, fraud and abuse, false claims, data privacy and security, and transparency laws and regulations related to drug
pricing and payments and other transfers of value made to physicians and other healthcare providers. If their operations are found to
be in violation of any of such laws or any other governmental regulations that apply, they may be subject to penalties, including, without
limitation, administrative, civil and criminal penalties, damages, fines, disgorgement, the curtailment or restructuring of operations,
integrity oversight and reporting obligations, exclusion from participation in federal and state healthcare programs and imprisonment.

Coverage and Reimbursement

In the United States, our
commercial success will depend in part on the extent to which governmental authorities, private health insurers and other third-party
payors provide coverage for and establish adequate reimbursement levels for our product candidates, if cleared or approved by the FDA.
Failure by physicians, hospitals, ambulatory surgery centers and other users of our products to obtain coverage and adequate