Company: REVB
Filing Date: 2025-04-04
Form Type: DRS
Source: 0001213900-25-029022
Chunk: 27

Company: REVELATION BIOSCIENCES, INC.
Filing Date: 2025-04-04
Form: DRS
Chunk 27
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 the 14 product from the market or suspension of manufacturing. If we, our product candidates or the manufacturing facilities for our product candidates fail to comply with applicable regulatory requirements, or undesirable side effects caused by such products are identified, a regulatory agency may: •issue safety alerts, Dear Healthcare Provider letters, press releases or other communications containing warnings about such product; •mandate modification to promotional materials or require us to provide corrective information to healthcare practitioners; •require that we conduct post -marketingstudies; •require us to enter into a consent decree, which can include imposition of various fines, reimbursements for inspection costs, required due dates for specific action and penalties for noncompliance; •seek an injunction or impose civil or criminal penalties or monetary fines; •suspend marketing of, withdraw regulatory approval of or recall such product; •suspend any ongoing clinical studies; •refuse to approve pending applications or supplements to applications filed by us; •suspend or impose restrictions on operations, including costly new manufacturing requirements; or •seize or detain products, refuse to import or export products or require us to initiate a product recall. The occurrence of any event or penalty described above may inhibit our ability to commercialize our products and generate product revenue. If one or more of our Program Products is approved for marketing in the United States or other countries, we may be subject, directly or indirectly, to United States or other countries equivalent federal and state healthcare fraud and abuse laws, false claims laws, physician payment transparency laws and health information privacy and security laws. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties. Even if we obtain FDA or other comparable regulatory agencies approval for any of our Program Products and begin commercializing those products in the United States or other countries, our operations may be directly or indirectly through our relationships with physicians, patients, third -partypayors and customers, subject to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain our business or financial arrangements and relationships through which we research, market, sell and distribute our Program Products. In addition, we may be subject to patient privacy regulation by both the federal government and the states in which we conduct our business. The laws that may affect our ability to operate include, among others, the United States Anti -KickbackStatute, the False Claims Act, the United States Health Insurance Portability and Accountability Act of 1996, and the Sunshine Act and analogous state laws. Ensuring that our internal operations and business arrangements with