Company: REVB
Filing Date: 2025-04-04
Form Type: DRS
Source: 0001213900-25-029022
Chunk: 65

Company: REVELATION BIOSCIENCES, INC.
Filing Date: 2025-04-04
Form: DRS
Chunk 65
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 such countries regarding the safety and efficacy of our product candidates and governing, among other things, clinical studies and commercial sales, pricing and distribution of our product candidates, and we cannot predict success in these jurisdictions. We may not obtain foreign regulatory approvals on a timely basis, if at all. If we obtain approval of our product candidates and ultimately commercialize our product candidates in foreign markets, we would be subject to additional risks and uncertainties, including: •our customers’ ability to obtain reimbursement for our product candidates in foreign markets; •our inability to directly control commercial activities if we are relying on third parties; the burden of complying with complex and changing foreign regulatory, tax, accounting and legal requirements; •different medical practices and customs in foreign countries affecting acceptance in the marketplace; •import or export licensing requirements; •longer accounts receivable collection times; •our ability to supply our product candidates on a timely and large -scalebasis in local markets; •longer lead times for shipping which may necessitate local manufacture of our product candidates; •language barriers for technical training and the need for language translations; •reduced protection of patent and other intellectual property rights in some foreign countries; •the existence of additional potentially relevant third -partyintellectual property rights; 36 •foreign currency exchange rate fluctuations; and •the interpretation of contractual provisions governed by foreign laws in the event of a contract dispute. Foreign sales of our product candidates could also be adversely affected by the imposition of governmental controls, political and economic instability, trade restrictions and changes in tariffs. If any of our product candidates is approved for commercialization, we may selectively partner with third parties to market it in certain jurisdictions outside the United States. We expect that we will be subject to additional risks related to international pharmaceutical operations, including: •different regulatory requirements for drug approvals and rules governing drug commercialization in foreign countries, including requirements specific to biologics or cell therapy products; •reduced protection for patent and other intellectual property rights; •foreign reimbursement, pricing and insurance regimes; •potential noncompliance with the U.S. Foreign Corrupt Practices Act, the U.K. Bribery Act 2010 and similar anti -briberyand anticorruption laws in other jurisdictions; and •production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad. We have no prior experience in these areas. In addition, there are complex regulatory, tax, labor and other legal requirements imposed by both the EU and many of the individual countries in Europe with which we will need to comply. Many