Item 1B. Unresolved Staff Comments
ITEM 1B. UNRESOLVED STAFF COMMENTS
None.
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ITEM 1C. CYBERSECURITY
Risk management and strategy
We maintain various information
security processes designed to identify, assess and manage material risks from cybersecurity threats to our critical computer networks,
third party hosted services, communications systems, hardware and software, and our critical data, including intellectual property, confidential
information that is proprietary, strategic or competitive in nature, information related to our clinical trials, and information of our
employees, or Information Systems and Data.
The Company’s CEO/CFO, with
assistance from our third-party cybersecurity vendors, is responsible for identifying, assessing, and managing our cybersecurity threats
and risks. Together, they identify and assess risks from cybersecurity threats by monitoring and evaluating our threat environment using
various methods including, for example, automated tools, evaluating our and our industry’s risk profile, conducting real-time monitoring
of certain systems, and implementing escalation protocols with our third-party cybersecurity vendors.
Depending on the environment,
we implement and maintain various technical, physical, and organizational measures, processes, standards and policies designed to manage
and mitigate material risks from cybersecurity threats to our Information Systems and Data, including, for example: an incident response
plan; incident detection and response tools; encryption of certain sensitive data and certain data on mobile systems; certain access controls
enforcing the principle of need-to-know encryption of certain sensitive data and certain data on mobile systems; physical security measures;
asset management, tracking and disposal; monitoring of certain systems; and employee training.
Our assessment and management
of material risks from cybersecurity threats are integrated into our overall risk management processes. For example, cybersecurity risk
is addressed through our quality management system and processes and overseen by our audit committee of the board of directors. We use
third-party service providers to assist us from time to time to identify, assess, and manage material risks from cybersecurity threats,
including, for example, professional services firms, including legal counsel and certain cybersecurity service providers.
We use third-party service providers
to perform a variety of functions throughout our business, such as hosting companies and contract research organizations. We have a vendor
management program to manage cybersecurity risks associated with our use of these providers. The program includes conducting a risk assessment
for certain vendors.
For a description of the risks from cybersecurity threats that may materially affect the Company and how they may
do so, see our risk factors under Part 1. Item 1A. Risk Factors in this Annual Report on Form 10-K, including “ If our information
technology systems, or those of third parties with whom we work, or our data are or were compromised, we could experience adverse consequences
resulting from such compromise, including but not limited to: regulatory investigations or actions; litigation; fines and penalties;
disruptions of our business operations; reputational harm; loss of revenue or profits; and other adverse consequences. ”
Governance
Our
board of directors addresses the Company’s cybersecurity risk management as part of its general oversight function. The board
of directors’ audit committee is responsible for overseeing the Company’s cybersecurity risk management processes,
including oversight of mitigation of risks from cybersecurity threats.
Our cybersecurity risk assessment
and management processes are implemented and maintained by certain Company management, including the CEO/CFO.
The CEO/CFO is
responsible for hiring appropriate personnel (including selecting third-party cybersecurity vendors), helping to integrate
cybersecurity risk considerations into the Company’s overall risk management strategy, and communicating key priorities to
relevant personnel. The CEO/CFO is responsible for approving budgets, helping prepare for cybersecurity incidents, approving
cybersecurity processes, and reviewing security assessments and other security-related reports. While Mr. Frakes does not hold
formal cybersecurity credentials or have dedicated prior professional experience in cybersecurity risk management, he is supported
in this function by qualified third-party cybersecurity service providers, upon whose specialized expertise the Company relies to
supplement management's assessment, identification, and oversight of material cybersecurity threats and risks.
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Our cybersecurity incident response
plan is designed to escalate certain cybersecurity incidents to members of management depending on the circumstances, including CEO/CFO.
The CEO/CFO works with our incident response team to help us mitigate and remediate cybersecurity incidents of which they are notified.
In addition, our incident response plan includes reporting to the audit committee of the board of directors for certain cybersecurity
incidents.
The audit committee receives periodic
reports from the CEO/CFO concerning our significant cybersecurity threats and risks and the processes we have implemented to address them.
The audit committee also has access to various reports, summaries or presentations related to cybersecurity threats, risks and mitigation.