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collaborations with BI may not be scientifically or commercially successful due to a number of important factors, including the
- BI has wide discretion in determining the efforts and resources that it will apply to its collaborations with us. The
timing and amount of any development milestone payments, and downstream commercial milestone payments and royalties that we may receive under such partnership will depend on, among other things, the
efforts, allocation of resources and successful development and commercialization of these product candidates by BI.
- BI may terminate either or both of its collaborations with us without
cause and for circumstances outside of our control,
which could make it difficult for us to attract new strategic partners or adversely affect how we are perceived in scientific and financial communities.
- BI may develop or commercialize
our product candidates in such a way as to elicit litigation that could jeopardize or
invalidate our intellectual property rights or expose us to potential liability.
- BI may not comply with all applicable regulatory requirements, or fail to report safety data in
accordance with all
applicable regulatory requirements.
- If BI were to breach its arrangements with us, we may need to enforce our right to terminate the applicable agreement in
legal proceedings, which could be costly and cause delay in our ability to receive rights back to the relevant product candidates. If we were to terminate an agreement with BI due to BI's breach or BI
terminated the agreement without cause, the development and commercialization of VTP-34072 and VTP-37948 could be delayed, curtailed or terminated because we may not have sufficient financial
resources or capabilities to continue development and commercialization of these candidates on our own.
- BI may enter into one or more transactions with third parties, including a merger,
consolidation, reorganization, sale of
substantial assets, sale of substantial stock or other change in control, which could divert the attention of its management and adversely affect BI's ability to retain and motivate key personnel who
are important to the continued development of the programs under the strategic partnership with us. In addition, the third-party to any such transaction could determine to reprioritize BI's
development programs such that BI ceases to diligently pursue the development of our programs or cause the respective collaboration with us to terminate.
We and BI rely on third parties to conduct preclinical studies and clinical trials for our product candidates, and if they do not properly and successfully perform their
obligations to us, we may not be able to obtain regulatory approvals for our product candidates.
We plan to design the clinical trials for VTP-43742, VTP-38443, VTP-38543 and expect to do so for any future unpartnered product
candidates, and we will continue to work with BI on trials for VTP-34072 and VTP-37948. However, we and BI rely on CROs and other third parties to assist in managing, monitoring and otherwise carrying
out many of these studies and trials. We and BI compete with many other companies for the resources of these third parties. The third parties on whom we and BI rely generally may terminate their
engagements at any time, and having to enter into alternative arrangements would delay development and commercialization of our product candidates.
FDA and foreign regulatory authorities require compliance with regulations and standards, including GCP, for designing, conducting, monitoring, recording, analyzing, and reporting
the results of clinical trials to assure that the data and results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected. Although we and BI
rely on third parties to conduct many of our and their clinical trials, we and BI are responsible for ensuring that each of these clinical trials is conducted in accordance with its general
investigational plan, protocol and other requirements.
these third parties do not successfully carry out their duties under their agreements, if the quality or accuracy of the data they obtain is compromised due to their failure to adhere
to clinical trial protocols or to regulatory requirements, or if they otherwise fail to comply with clinical trial protocols or meet
expected deadlines, the clinical trials of our product candidates may not meet regulatory requirements. If clinical