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 computer networks, third party hosted services, communications systems, hardware and software, and our critical data, including intellectual property, and confidential information that is proprietary, strategic or competitive in nature (“Information Systems and Data”).

Our Enterprise Risk Management Committee, together with the company’s security and legal teams as well as third party service providers, help identify, assess and manage the Company’s cybersecurity threats and risks. Additionally, the Enterprise Risk Management Committee, the security team, the legal teams and the Company’s third party service providers identify and assess risks from cybersecurity threats by monitoring and evaluating our threat environment and the Company’s risk profile using various methods including, for example using manual and automated tools, subscribing to reports and services that identify cybersecurity threats, conducting scans of the threat environment, evaluating our and our industry’s risk profile, evaluating threats reported to us, conducting assessments of controls, conducting threat and vulnerability assessments, and engaging in simulated penetration testing and tabletop incident response exercises organized by third-party specialists.

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: maintaining incident response plans and policies, conducting periodic risk assessments, implementing security standards and certifications, encrypting data, maintaining network security controls, segregating data, maintaining physical security controls, system and data monitoring tools, periodic employee security training and simulation testing, penetration testing, and maintaining cybersecurity insurance.

Our assessment and management of material risks from cybersecurity threats are integrated into the Company’s overall risk management processes. Our cybersecurity risk management framework is based on the National Institute of Standards and Technology's Guide for Conducting Risk Assessments. For example, cybersecurity risks are assessed upon pre-defined matrices of probability and potential impact. Such risks are then recorded within an enterprise risk register along with risk treatment plans for approval from the Enterprise Risk Management Committee.

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, cybersecurity consultants, 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 application providers, hosting companies, contract research organizations, contract manufacturing organizations, distributors and supply chain resources. Depending on the nature of the services provided, the sensitivity of the Information Systems and Data at issue, and the identity of the provider, our vendor management process may involve different levels of assessment designed to help identify cybersecurity risks associated with a provider and impose contractual obligations related to cybersecurity on the provider.

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 General Risk Factors in this Annual Report on Form 10-K, including the risk factor titled “If our information technology systems or data, 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; a material disruption of our product candidates’ development programs; reputational harm; loss of revenue or profits; loss of customers or sales; and other adverse consequences.”

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Governance

Our board of directors addresses the Company’s cybersecurity risk management as part of its general oversight function. The Audit Committee is responsible for overseeing 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 the Vice President of IT, Director of IT Operations, and General Counsel.

Our Vice President of IT and Director of IT Operations are 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. Our Vice President of IT is responsible for helping prepare for cybersecurity incidents, approving cybersecurity processes, and reviewing security assessments and other security-related reports.

Our cybersecurity incident response processes and policy are designed to escalate certain cybersecurity incidents to members of management depending on the circumstances. Our Security team and General Counsel work with the Company’s incident response team to help the Company mitigate and remediate cybersecurity incidents of which they are notified. In addition, the Company’s incident response processes and policy include reporting to the board of directors for certain cybersecurity incidents.

The board of directors receives periodic reports from the Enterprise Risk Management Committee and the Vice President of IT concerning the Company’s significant cybersecurity threats and risk and the processes the Company has implemented to address them. The board of directors also has access to various reports, summaries or presentations related to cybersecurity threats, risk and mitigation.