Company: TELO
Filing Date: 2025-02-04
Form Type: 10-K
Source: 0001493152-25-004872
Chunk: 319

Company: Telomir Pharmaceuticals, Inc.
Filing Date: 2025-02-04
Form: 10-K
Item: Item 1
Chunk 319
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 the referral of business,
including the purchase, order or prescription of a particular drug for which payment may be made under a federal health care program,
such as Medicare or Medicaid. Under federal law, some arrangements, known as safe harbors, are deemed not to violate the federal Anti-Kickback
Statute. Although we seek to structure our business arrangements in compliance with all applicable requirements, it is often difficult
to determine precisely how the law will be applied in specific circumstances. Accordingly, it is possible that our practices may be challenged
under the federal Anti-Kickback Statute and Federal False Claims Act. Violations of fraud and abuse laws may be punishable by criminal
and/or civil sanctions, including fines and/or exclusion or suspension from federal and state health care programs such as Medicare and
Medicaid and debarment from contracting with the U.S. government. In addition, private individuals have the ability to bring actions
on behalf of the government under the federal False Claims Act as well as under the false claims laws of several states.

Many
states have adopted laws similar to the federal anti-kickback statute, some of which apply to the referral of patients for health care
services reimbursed by any source, not just governmental payers. There are ambiguities as to what is required to comply with these state
requirements and if we fail to comply with an applicable state law requirement, we could be subject to penalties.

Neither
the government nor the courts have provided definitive guidance on the application of fraud and abuse laws to our business. Law enforcement
authorities are increasingly focused on enforcing these laws, and it is possible that some of our practices may be challenged under these
laws. While we believe we have structured our business arrangements to comply with these laws, it is possible that the government could
allege violations of, or convict us of violating, these laws. If we are found in violation of one of these laws, we could be required
to pay a penalty and could be suspended or excluded from participation in federal or state health care programs, and our business, results
of operations and financial condition may be adversely affected.

Serious
adverse events or other safety risks could require us to abandon development and preclude, delay or limit approval of our product candidates,
limit the scope of any approved label or market acceptance, or cause the recall or loss of marketing approval of products that are already
marketed.

If
any of our product candidates prior to or after any approval for commercial sale, cause serious or unexpected side effects