Company: RGNT
Filing Date: 2025-01-24
Form Type: DRS
Source: 0001213900-25-006245
Chunk: 58

Company: REGENTIS BIOMATERIALS LTD.
Filing Date: 2025-01-24
Form: DRS
Chunk 58
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 of recalls and corrections, even if they are not reportable to the FDA. We may initiate voluntary withdrawals
or corrections for our products in the future that we determine do not require notification of the FDA. If the FDA disagrees with our
determinations, it could require us to report those actions as recalls and we may be subject to enforcement action. A future recall announcement
could harm our reputation with customers, potentially lead to product liability claims against us and negatively affect our sales. Any
corrective action, whether voluntary or involuntary, as well as defending ourselves in a lawsuit, will require the dedication of our time
and capital, distract management from operating our business and may harm our reputation and financial results.

Our relationships with customers and third-party payors will be subject to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.

Physicians, other healthcare
providers, and third-party payors will play a primary role with respect to any future products for which we obtain marketing approval.
Our arrangements with third-party payors and customers may expose us to broadly applicable fraud and abuse and other healthcare laws and
regulations that may constrain the business or financial arrangements and relationships through which we market, sell and distribute our
product.

Restrictions under applicable
federal and state healthcare laws and regulations include the following:

| ● | The U.S. federal healthcare program Anti-Kickback Statute prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made, in whole or in part, under federal healthcare programs such as Medicare and Medicaid. Although there are a number of statutory exemptions and regulatory safe harbors protecting certain common activities from prosecution, the exemptions and safe harbors are drawn narrowly and practices that involve remuneration to those who prescribe, purchase, or recommend medical devices, including certain discounts, or engaging consultants as speakers or consultants, may be subject to scrutiny if they do not fit squarely within the exemption or safe harbor. Our practices may not in all cases meet all of the criteria for safe harbor protection from anti- kickback liability. Moreover, there are no safe harbors for many common practices, such as educational and research grants.