The Spectrum Pharmaceuticals Inc. Board of Directors and senior management are in support of and are committed to a corporate culture of compliance facilitated by the Compliance and Ethics Program. Evidence of that commitment includes the allocation of adequate resources, a timetable for the implementation of the compliance measures, and the identification of an individual to serve as a Chief Compliance Officer to ensure that each of the recommended and adopted elements is addressed. It is an expectation of the Board of Directors and senior management the commitment should filter down through management to every employee and third-party vendor, as applicable for the individual.
At Spectrum we foster a culture that promotes the prevention, detection, and resolution of instances of problems. The primary manner we do this is by maintaining the company Compliance and Ethics Program, which is a set of internal controls and standards that promote adherence to pharmaceutical industry statutes, regulations, and requirements of the federal health care programs with respect to the development, manufacturing, marketing and selling of Spectrum products.
Spectrum’s foundation is built on strong ethical principles and values which reflect our commitment to conducting business with honesty, fairness and integrity; whereby we avoid doing anything that could even suggest impropriety in any of our dealings.
Spectrum abides by the following core principles:
|You may contact Spectrum's Compliance Officer at any time at: firstname.lastname@example.org|
|Notice of Compliance|
|Code of Business Conduct and Ethics|
|Code of Business Conduct and Ethics in Spanish (en español).|
The Spectrum Pharmaceuticals, Inc. Compliance and Ethics Program is overseen and managed by the following committees and officers:
Assists the Board of Directors exercise its oversight of the Company’s compliance with applicable laws and regulations through the implementation of an effective Compliance and Ethics Program. The membership, structure, and roles and responsibilities of the Audit Committee in overseeing the Compliance and Ethics Program are set forth in the Company’s Audit Committee Charter, as reviewed and approved by the Board of Directors.
The Audit Committee is comprised of three (3) directors, each of whom meet the independence requirements and financial literacy requirements set forth in the listing rules of the NASDAQ Stock Market, Inc. (NASDAQ) and the applicable rules and regulations of the Securities and Exchange Commission (SEC). Each committee member must be able to read and understand fundamental financial statements, including a balance sheet, income statement and cash flow statement.
At least one (1) member of the committee must be financially sophisticated, as determined by the Board, and no committee member may have participated in the preparation of the financial statements of the Company or any of the Company’s current subsidiaries at any time during the past three years, each as required by the NASDAQ listing rules. In addition, at least one (1) member of the committee must be an “audit committee financial expert” under applicable SEC rules.
The Audit Committee is responsible for:
Manages the creation, development, implementation, operation, monitoring, and enforcement of the Company’s Compliance and Ethics Program and the day-to-day function and administration of the Compliance and Ethics Department. The roles and responsibilities of the Chief Compliance Officer are set forth in the Chief Compliance Officer Job Description, as reviewed and approved by the Chief Executive Officer and the Audit Committee of the Board of Directors.
The Chief Compliance Officer is responsible for:
Guidance and Reporting to Management and the Board of Directors
Administrative and Operational Oversight of the Compliance and Ethics Department
Implement Written Standards, Policies, and Procedures
Ensure Effective Communication, Education, and Training
Monitoring, Auditing, and Internal Reporting Systems
Investigations and Corrective Actions
The Compliance Committee is a sub-committee of the Audit Committee of the Board of Directors that evaluates the effectiveness of the Company’s Compliance and Ethics Program through the review and approval of the Company’s Code of Business Conduct and Ethics and related policies, procedures, and internal controls reasonably designed to comply with applicable laws and regulations. The membership, structure, and roles and responsibilities of the Compliance Committee, a management-level committee, are set forth in the Company’s Compliance Committee Charter, as reviewed and approved by the Chief Executive Officer and the Audit Committee of the Board of Directors.
The Compliance Committee is composed of senior members of management, representing certain core departments and functions across the Company. Each member must be of sufficient seniority to represent his/her respective department’s views and support the Compliance and Ethics Program, as needed. The committee is chaired by the Chief Compliance Officer and comprised of at least five members from the following departments:
The Compliance Committee is responsible for:
The Funding and Support Request Review Committee is a sub-committee of the Compliance Committee that reviews and approves funding and support requests from outside organizations against a series of guidelines as a duly authorized sub-committee of the Compliance Committee. The membership, structure, and roles and responsibilities of the Funding and Support Request Review Committee are set forth in the Company’s Funding and Support Request Review Committee Charter, as reviewed and approved by the Company’s Compliance Committee.
The Funding and Support Request Review Committee is chaired by the Chief Compliance Officer and supported by the Chief Medical Officer and comprised of at least three individuals from the following departments:
The committee is responsible for:
Advises the Company on the legal and regulatory risks and counsels management, the Audit Committee of the Board of Directors and the Board of Directors regarding applicable laws and regulations that govern, relate to, or impact the Company’s day-to-day operations and strategy. Manages the day-to-day function and administration of the Legal Department. The roles and responsibilities of the Chief Legal Officer are set forth in the Chief Legal Officer Job Description, as reviewed and approved by the Chief Executive Officer.
At Spectrum organizational expectations are documented to ensure employees understand the organization’s culture, expectations and requirements. All employees are required to read, understand and acknowledge all policies and procedures applicable to their roles and responsibilities.
Policies address an organization’s guiding principles, whereas procedures address a sequence of steps to be followed in a consistent manner.
At Spectrum compliance is fundamental to the company’s success. Each year Spectrum sets a corporate goal specific to compliance and whether or not an individual meets the goal is a component of their annual performance review.
Spectrum is committed to developing and implementing regular, effective education and training programs for all affected employees and third parties.
At Spectrum training and education enables individuals to recognize their obligations to comply with the organization’s policies and procedures and identify high risk areas, which reduces the probability of non-compliant conduct.
Our training curricula are tailored to an individual’s role within the organization. Employees are not permitted to conduct any activities without prior training codified in a documented training record.
Spectrum is committed to creating and maintaining an effective line of communication between the Chief Compliance Officer and all employees, including a process (such as a Helpline or other reporting system) to receive complaints or questions, and the adoption of procedure to protect the anonymity of complainants and to protect whistleblowers from retaliation.
At Spectrum, all employees have a duty to report any known or suspected violation of law, rules or regulations that apply to the company. All reports are handled with sensitivity and discretion. The identity of the individual who reports any information will be protected, to the extent possible, consistent with applicable law and Spectrum’s need to investigate an allegation.
There are many resources at Spectrum that can be leveraged to ask questions or report any suspected instances of misconduct including Supervisors, Human Resources, Compliance and Legal. Additionally, there is the Compliance Helpline in the event the individual reporting the information would prefer to remain anonymous:
Toll Free Phone: 1-844-587-1660
Spectrum prohibits retaliation against an employee who, in good faith, seeks help or reports known or suspected violations; including participating in an investigation or opposing any unlawful or discriminatory practices.
At Spectrum, employees who demonstrate the Company’s commitment to compliance and ethics are publicly recognized and rewarded. This includes, but is not limited to, individuals who lead others to conduct business activities in a compliant manner, individuals who proactively ask for assistance for compliance and ethics related challenges and those who do the right thing when faced with an ethical dilemma.
Spectrum is committed to using audits and/or other risk evaluation techniques to monitor compliance, identify problem areas and assist in the reduction of identified problems.
Compliance risk is the threat posed to an organization’s financial, organizational, or reputational standing resulting from violations of laws, regulations, codes of conduct, or organizational standards of practice.
Spectrum proactively conducts risk assessments to determine which risks have the greatest potential for legal, financial, operational, or reputational damage; and thereby allocates resources to manage and mitigate those risks.
Compliance auditing is a retrospective assessment of activities to determine if behaviors were consistent with policies and procedures. Compliance monitoring is an observation of real time activities.
Spectrum proactively conducts routine auditing and monitoring of business processes in accordance with the annual Compliance Auditing and Monitoring plan, that is approved by the Board of Directors and the Compliance Committee. Additionally, Spectrum conducts for cause audits in the event they are deemed necessary.
Spectrum is committed to developing policies and procedures addressing the non-employment or retention of individuals or entities excluded from participation in federal health care programs and enforcing appropriate disciplinary action against employees or third parties who have violated company policies and procedures and/or applicable federal health care program requirements.
Spectrum proactively screens candidates for employment or third parties for exclusion, debarment or any other ineligibility in federal healthcare programs or government contracts. If Spectrum determines a candidate is a Debarred/Excluded Person, Spectrum will not employ or contract with such candidate.
All Spectrum employees and contracted third parties have a duty to self-disclose any information that might preclude their involvement in Spectrum business operations. If Spectrum is notified or otherwise informed a contracted third party is a Debarred/Excluded Person, Spectrum will terminate the agreement.
Only employees who are required to regularly access Spectrum investigational or marketed products as a function of their job duties shall have access to such products.
Employee involvement in Drug Diversion is strictly prohibited.
In the event of employment termination, the access must be revoked immediately.
In the event of an employment transfer, and prior to the transfer 1) an analysis must be conducted to determine if the individual will still require access to product in their new role. If not, the access must be revoked immediately. If access is still required, it shall be appropriate as a function of their new job duties; 2) a due diligence screening must be conducted.
Spectrum prohibits violations of law and Company policies conducted in a knowingly and willful manner. Violators may expose themselves to substantial civil damages, criminal fines and prison terms. Spectrum may also face substantial fines/penalties and may incur damage to its reputation and standing in the community.
At Spectrum employment is “at will” and can be terminated at any time, with or without cause, and with or without prior notice. Depending on the circumstances, Spectrum may choose to implement progressive discipline, however is under no obligation to do so.
Spectrum is committed to developing policies and procedures for the investigation of identified instances of noncompliance or misconduct. These include directions regarding the prompt and proper response to detected offenses, such as the initiation of appropriate corrective action and preventive measures and processes to report the offense to relevant authorities in appropriate circumstances.
At Spectrum, the facts and circumstances of each particular situation undergo a thorough review and violations are addressed in an appropriate manner.
Spectrum is committed to reporting all transactions that constitute a payment or transfer of value to a healthcare professional (HCP) or healthcare organization (HCO).
At Spectrum it is the responsibility of each employee to track all applicable transactions, regardless of whether the employee is seeking reimbursement for expenses. Individual employees may be held financially responsible for any Company penalties incurred as a result of the individual employee failing to report or inaccurately reporting a transaction to the Company. If an individual is ever in doubt as to whether a payment or transfer of value should be reported, they should err on the side of reporting.