Company: INMB
Filing Date: 2025-03-27
Form Type: 10-K
Source: 0001013762-25-003354
Chunk: 47

Company: Inmune Bio, Inc.
Filing Date: 2025-03-27
Form: 10-K
Item: Item 1
Chunk 47
---
 aggregate of $1 million per year for “knowing failures”), for all
payments, transfers of value or ownership or investment interests that are not timely, accurately, and completely reported in an annual
submission. Additionally, entities that do not comply with mandatory reporting requirements may be subject to a corporate integrity agreement.
Certain states also mandate implementation of commercial compliance programs, impose restrictions on covered manufacturers’ marketing
practices and/or require the tracking and reporting of gifts, compensation and other remuneration to physicians and other healthcare professionals.

We may also be subject to
data privacy and security regulation by both the federal government and the states in which we conduct our business. HIPAA, as amended
by the Health Information Technology and Clinical Health Act, or HITECH, and their respective implementing regulations, imposes specified
requirements on certain health care providers, plans and clearinghouses (collectively, “covered entities”) and their “business
associates,” relating to the privacy, security and transmission of individually identifiable health information. Among other things,
HITECH makes HIPAA’s security standards directly applicable to “business associates,” defined as independent contractors
or agents of covered entities that create, receive, maintain or transmit protected health information in connection with providing a service
for or on behalf of a covered entity. HITECH also increased the civil and criminal penalties that may be imposed against covered entities,
business associates and possibly other persons, and gave state attorneys general new authority to file civil actions for damages or injunctions
in federal courts to enforce HIPAA and seek attorney’s fees and costs associated with pursuing federal civil actions. In addition,
certain states have their own laws that govern the privacy and security of health information in certain circumstances, many of which
differ from each other and/or HIPAA in significant ways and may not have the same effect, thus complicating compliance efforts.

27

Coverage and Reimbursement

Sales of pharmaceutical products
depend significantly on the extent to which coverage and adequate reimbursement are provided by third-party payors. Third-party payors
include state and federal government health care programs, managed care providers, private health insurers and other organizations. Although
we currently believe that third-party payors will provide coverage and reimbursement for our product candidates, if approved, we cannot
be certain of this. Third-party payors are increasingly challenging the price, examining the cost-effectiveness, and reducing reimbursement
for medical products and services. In addition, significant uncertainty exists as to the reimbursement status of newly approved healthcare
products. The U.S. government