||we may not be able to control the amount and timing of resources that the collaboration partner devotes to the product development program;|
||the collaboration partner may experience financial difficulties;|
||we may be required to grant or otherwise relinquish important rights such as marketing, distribution and intellectual property rights;|
||a collaboration partner could move forward with a competing product developed either independently or in collaboration with third parties, including our competitors; or|
||business combinations or significant changes in a collaboration partner’s business strategy may adversely affect our willingness to continue any arrangement.|
We rely on third parties to conduct our nonclinical
and clinical studies and perform other tasks for us. If these third parties do not successfully carry out their contractual duties,
meet expected deadlines, or comply with regulatory requirements, we may not be able to obtain regulatory approval for or commercialize
our product candidates and our business could be substantially harmed.
We have relied upon and plan to continue
to rely upon third-party clinical research organizations, or CROs, to monitor and manage data for our ongoing nonclinical and clinical
programs, including the clinical studies of our product candidates. We rely on these parties for execution of our nonclinical and
clinical studies and control only certain aspects of their activities. Nevertheless, we are responsible for ensuring that each
of our studies is conducted in accordance with the applicable protocol, legal, regulatory and scientific standards and our reliance
on the CROs does not relieve us of our regulatory responsibilities. We and our CROs and other vendors are required to comply with
current good manufacturing practices, or cGMP, current good clinical practice, or cGCP, and Good Laboratory Practice, or GLP, which
are regulations and guidelines enforced by the FDA, the Competent Authorities of the Member States of the European Union and comparable
foreign regulatory authorities for all of our product candidates in nonclinical and clinical development. Regulatory authorities
enforce these regulations through periodic inspections of study sponsors, principal investigators, study sites and other contractors.
If we or any of our CROs or vendors fail to comply with applicable regulations, the data generated in our nonclinical and clinical
studies may be deemed unreliable and the EMA, FDA, other regulatory authorities may require us to perform additional nonclinical
and clinical studies before approving our marketing applications. We cannot assure you that upon inspection by a given regulatory
authority, such regulatory authority will determine that all of our clinical studies comply with cGCP regulations. In addition,
our clinical studies must be conducted with products produced under cGMP regulations. Our failure to comply with these regulations
may require us to repeat clinical studies, which would delay the regulatory approval process.
If any of our relationships with these
third-party CROs terminates, we may not be able to enter into arrangements with alternative CROs or do so on commercially reasonable
terms. In addition, our CROs are not our employees, and except for remedies available to us under our agreements with such CROs,
we cannot control whether or not they devote sufficient time and resources to our on-going nonclinical and clinical programs. If
CROs do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced
or if the quality or accuracy of the data they obtain is compromised due to the failure to adhere to our protocols, regulatory
requirements, or for other reasons, our clinical studies may be extended, delayed, or terminated and we may not be able to obtain
regulatory approval for or successfully commercialize our product candidates. CROs may also generate higher costs than anticipated.
As a result, our results of operations and the commercial prospects for our product candidates would be harmed, our costs could
increase, and our ability to generate revenue could be delayed.
Switching or adding additional CROs involves
additional cost and requires management time and focus. In addition, there is a natural transition period when a new CRO commences
work. As a result, delays occur, which can materially impact our ability to meet our desired clinical development timelines. Though
we carefully manage our relationships with our CROs, there can be no assurance that we will not encounter similar challenges or
delays in the future or that these delays or challenges will not have a material adverse impact on our business, financial condition