Item 1B. Unresolved Staff Comments
Item 1B. Unresolved Staff Comments.
Not applicable.
Item 1C. Cybersecurity.
Risk management and strategy
We have implemented and maintain various information security processes designed to identify, assess and manage material risks from cybersecurity threats to our critical infrastructure, 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, and data related to our clinical trials and technology platform (“Information Systems and Data”).
Our Information Systems security function, led by our Vice President for Information Systems and Director of Information Systems security, helps identify, assess and manage the Company’s cybersecurity threats and risks. This function evaluates risks by continuously monitoring and analyzing our threat environment and risk profile using various methods including automated tools, subscribing toreports and services that identify cybersecurity threats, analyzing reports of threats and actors, conducting scans of the Company’s threat environment, evaluating threats that are reported to us, conducting internal audits, internal and external threat assessments, third party threat assessments, and conducting vulnerability assessments.
Depending on the environment and system, 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. These include, for example: an information systems security policy; security incident management; disaster recovery procedures; periodic backup recovery tests; risk assessments; encryption of certain data; network security controls; data segregation for certain systems and environments; access controls; physical security; asset management, tracking, and disposal; systems monitoring; employee training and phishing simulations; periodic penetration tests; outsourced managed detection and response services; maintaining cybersecurity insurance; and having dedicated cybersecurity staff.
Our assessment and management of material risks from cybersecurity threats are integrated into the Company’s overall risk management processes. For example, cybersecurity risk is addressed as a component of the Company’s enterprise risk management program and identified in the Company’s risk mapping and management documentation. The cybersecurity component of the Company’s risk mapping and management documentation is updated
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annually, and our Information Systems security function prepares cybersecurity roadmaps designed to prioritize our risk management processes and mitigate cybersecurity threats that are more likely to lead to a material impact to our business.
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, cybersecurity software providers, managed cybersecurity service providers, and penetration testing firms.
We use third-party service providers to perform a variety of functions throughout our business, such as CROs, CMOs, cloud hosting and other SaaS providers. Depending on the nature of the services provided, the sensitivity of the Information Systems and Data at issue, and the identity of the provider, we take various measures designed to help manage risk associated with our use of certain of these providers. These measures include, for example, obtaining confirmation of certain cybersecurity certifications, information security questionnaires, and imposition of certain contractual obligations.
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, including If our information technology systems or sensitive information, or those of third parties upon which we rely, 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 and mitigation of risks from cybersecurity threats.
Our cybersecurity risk assessment and management processes are implemented and maintained by certain Company management, including, but not limited to, Cyril Guyardeau, our Director of Information Systems Security, who had previously spent 15 years as an IT infrastructure engineer in the healthcare industry, and Cecile Delansorne, our Vice President for Information Systems, who has held similar executive positions overseeing information systems in other pharmaceutical companies for over seven years. Our Vice President for Information Systems reports to our Chief Financial Officer.
The Vice President for Information Systems is responsible for hiring appropriate personnel, helping to integrate cybersecurity risk considerations into the Company’s overall risk management strategy, and communicating key priorities to relevant personnel. The Vice President for Information Systems is also responsible for approving budgets, helping prepare for cybersecurity incidents, approving cybersecurity processes, and reviewing security assessments and other security-related reports.
Our Information System security incident management procedure is designed to escalate certain cybersecurity incidents to members of management depending on the impact of the incident, including the Chief Financial Officer, Data Privacy Officer, Company Legal department, and Executive Committee, who work with the Company’s incident response team to help the Company mitigate and remediate cybersecurity incidents of which they are notified.
The audit committee may receive periodic reports from our Chief Financial Officer concerning the Company’s significant threats and risk, including, if applicable, those related to cybersecurity threats, and the processes the Company has implemented to address them. The Audit Committee also may have access to various reports, summaries or presentations related to cybersecurity threats, risk and mitigation.
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