Company: DVAX
Filing Date: 2025-08-07
Form Type: 10-Q
Source: 0001029142-25-000117
Chunk: 92

Company: DYNAVAX TECHNOLOGIES CORP
Filing Date: 2025-08-07
Form: 10-Q
Item: Part I, Item 4
Chunk 92
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 UK. Developing, seeking regulatory approval for and marketing our product candidates in or outside of the U.S., the EU and the UK in jurisdictions where we don't currently 

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have approval could impose substantial costs, impose burdens on our personnel, and divert management’s attention from domestic operations. International operations are subject to risk, including:

•the difficulty of managing geographically distant operations, including recruiting and retaining qualified employees, locating adequate facilities and establishing useful business support relationships in the local community;

•compliance with varying international regulatory requirements, laws and treaties;

•securing international distribution, marketing and sales capabilities upon favorable terms;

•adequate protection of our intellectual property rights;

•obtaining regulatory and pricing approvals at a level sufficient to justify commercialization;

•legal uncertainties and potential timing delays associated with tariffs, export licenses and other trade barriers;

•foreign tax compliance and diverse tax consequences;

•the fluctuation of conversion rates between foreign currencies and the U.S. dollar; and

•regional and geopolitical risks.

In the event that we determine to pursue commercialization of HEPLISAV-B outside the U.S., the EU and the UK, our opportunity will depend upon our receiving regulatory approval, which can be costly and time consuming, and there is a risk that one or more regulatory bodies may require that we conduct additional clinical trials and/or take other measures which will take time and require that we incur significant additional expense. In addition, we may not receive approval in one or more jurisdictions, even if we undertake these efforts.

The results of clinical trials conducted to support regulatory approval in one or more jurisdictions, and any failure or delay in obtaining regulatory approval in one or more jurisdictions, may have a negative effect on the regulatory approval process in other jurisdictions, including our existing regulatory approval in the U.S., the EU and UK. If we are unable to successfully manage our international operations, we may incur significant unanticipated costs and delays in regulatory approval or commercialization of our products or product candidates, which would impair our ability to generate revenues.

We rely on CROs and clinical sites and investigators for our clinical trials. If these third parties do not fulfill their contractual obligations or meet expected deadlines, our planned clinical trials may be delayed and we may fail to obtain the regulatory approvals necessary to commercialize our product candidates.

We rely on CROs, clinical sites and investigators for our clinical trials. If these third parties do not perform their obligations or meet expected deadlines our planned clinical trials may be extended, delayed, modified or terminated. While we maintain oversight