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- refusal by the FDA to approve pending applications or supplements to approved applications filed by us or our partners, or
suspension or revocation of product license approvals;
- product seizure or detention, or refusal to permit the import or export of products; and
- injunctions or the imposition of civil or criminal penalties.
FDA's policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates. We cannot predict the
likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If we or our partners are slow or unable
to adapt to changes in existing requirements or the adoption of new requirements or policies, or not able to maintain regulatory compliance, we or our partners may lose any marketing approval that may
have been obtained and we may not achieve or sustain profitability, which would adversely affect our business.
If we or our partners fail to obtain regulatory approval in jurisdictions outside the United States, we and they will not be able to market our products in those
We and our partners intend to market our product candidates, if approved, in international markets, alone or in conjunction with
others. Such marketing will require separate regulatory approvals in each market and compliance with numerous and varying regulatory requirements. The approval procedures vary from country-to-country
and may require additional testing. Moreover, the time required to obtain approval may differ from that required to obtain FDA approval. In addition, in many countries outside the United States, a
product candidate must be approved for reimbursement before it can be approved for sale in that country. Approval by the FDA does not ensure approval by regulatory authorities in other countries or
jurisdictions, and approval by one foreign regulatory authority does not ensure approval by regulatory authorities in other foreign countries or by the FDA. The foreign regulatory approval process may
include all of the risks associated with obtaining FDA approval. We or our partners may not be able to file for regulatory approvals and may not receive necessary approvals to commercialize our
products in any market.
Risks Related to Our Reliance on Third Parties
We are dependent on BI for the successful development and commercialization of two of our most advanced product candidates, VTP-34072 and VTP-37948. If BI does not devote
sufficient resources to the development of these candidates, is unsuccessful in its efforts, or chooses to terminate any of its agreements with us, our business will be materially harmed.
We have entered into collaboration agreements with BI pursuant to which BI has the responsibility to develop and commercialize
VTP-34072 and VTP-37948. Pursuant to these collaboration agreements, BI is responsible for all clinical and other product development, regulatory, manufacturing and commercialization activities and
cost for VTP-34072 and VTP-37948.
is obligated to use commercially reasonable efforts to develop and commercialize VTP-34072 and VTP-37948. Under our collaboration agreements, once BI takes over development activities
of a product candidate, it may determine the development plan and activities for that product candidate. We may disagree with BI about the development strategy it employs, but we will have no rights
to impose our development strategy on BI. In addition, BI may determine that it is commercially reasonable to develop and commercialize only VTP-34072 or VTP-37948 and discontinue the development or
commercialization of the other product candidate, or BI may determine that it is not commercially reasonable to continue development of one or both of VTP-34072 and VTP-37948. In the event of any such
decision, we may be unable to progress the discontinued candidate or candidates ourselves.
Similarly, BI may decide to seek regulatory approval for, and limit commercialization of, either or both of VTP-34072 and VTP-37948 to narrower indications than we would pursue. We would be prevented
from developing or commercializing a candidate in an indication covered by the collaboration agreements that BI has chosen not to pursue.