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Ethics & Compliance

Procedures and Standards of Conduct for Employees

In Baxalta’s pursuit for excellence on behalf of patients, caregivers and healthcare providers, Baxalta employees must achieve results the right way, doing business in compliance with Baxalta policy and legal requirements. To this end, Baxalta has adopted the fundamental principles of the Office of Inspector General Compliance Program Guidance. In addition to the HHS-OIG Guidance, Baxalta has adopted the following professional codes of conduct:

Baxalta also complies with the principles of the PhRMA Code in its interactions with healthcare professionals and abides by U.S. state laws that require adoption of a state-developed code of conduct that applies to interactions with certain healthcare professionals and institutions in a particular state, including the Massachusetts Marketing Code of Conduct.

Baxalta employees adhere to the company's written Global Code of Conduct and procedures related to interactions with the medical community and government officials. This includes an interactions policy and a procedure for providing grants to support medical/scientific research, engaging consultants for services and making charitable contributions and/or corporate sponsorships to customers and non-customers alike. In addition to employees, Baxalta’s commitment to doing business with integrity extends to its contractors, agents and suppliers as described in Baxalta’s Global Code of Conduct and Ethics & Compliance Standards For Baxalta Suppliers.

As required by California Health & Safety Code §§ 119400 et seq. ("California Law") also known as CA S.B. 1765, Baxalta has established an annual limit of $2,500 for certain expenditures to licensed healthcare professionals in California.

Personal Responsibilities

Baxalta employees are responsible for the integrity of their own work. Baxalta's policies and procedures provide additional, more specific guidance.

Each employee must acknowledge receipt of Baxalta's Global Code of Conduct and confirm that they understand and will comply with these standards. Baxalta's Global Code of Conduct emphasizes the importance of applying the company’s ethical principles and commitment to compliance in its employees’ decision-making process, and ultimately behavior. It also provides a channel for employees to raise questions and resolve issues.

Since Baxalta's Global Code of Conduct and the supporting policies and procedures may change from time to time, Baxalta employees are responsible for knowing and complying with the current laws, rules, regulations, standards, policies and procedures that govern their work. Baxalta employees are also individually responsible for reporting wrongdoing. If a law or company policy has been broken, employees are required to report it promptly. If a Baxalta employee fails to comply with applicable laws, rules, regulations, standards, policies and procedures, he or she risks being disciplined or terminated. If a Baxalta employee breaks the law, he or she may also be personally liable.

Manager's Responsibilities

Baxalta managers are responsible for maintaining an ethical climate.

Every Baxalta manager must:

  • Explain to their employees why it's important to comply with Baxalta's Global Code of Conduct.
  • Encourage discussion of the Code and situations in which it applies in day-to-day activities.
  • Respond promptly and properly to concerns raised by employees.
  • Protect employees against reprisals when they report, in good faith, actions they feel violate the law or Baxalta’s values, standards or policies.
  • Ensure that significant ethics and compliance issues are shared with Baxalta's investigations team and Public & Corporate Responsibility Office.

Board of Directors, Corporate Responsibility Office and Vice President and Associate General Counsel - Compliance

Any waiver of Baxalta's standards for executive officers or members of the Board of Directors may be made only by Baxalta's Quality and Compliance Committee, and is subject to approval by the entire Board. Also, any waiver must be promptly disclosed to shareholders as required by applicable law and stock exchange rules.

Baxalta's Quality and Compliance Committee of its Board of Directors is responsible for assisting the Board in fulfilling its oversight responsibilities with respect to legal, regulatory, quality and other compliance matters, including with respect to current and emerging political, corporate citizenship and public policy issues that may affect the business operations, performance or public image of the company. As part of that responsibility, the Quality and Compliance Committee oversees Baxalta's Global Code of Conduct.

To assist the Quality and Compliance Committee in carrying out these responsibilities, the Board of Directors created a Corporate Responsibility Office. The company's Vice President and Associate General Counsel – Compliance and the Corporate Responsibility Office are accountable directly to the Quality and Compliance Committee, and the Vice President and Associate General Counsel – Compliance regularly reports to the committee about ethics and compliance matters. In addition, the Vice President and Associate General Counsel – Compliance annually reports on compliance matters to the Board’s Audit Committee. The Corporate Responsibility Office is also responsible for communicating Baxalta’s ethics and compliance standards internally and externally, providing guidance and training to employees, maintaining multiple channels for employees to report concerns and monitoring compliance.

Baxalta's Vice President and Associate General Counsel – Compliance is responsible for the coordination, oversight and enforcement of Baxalta's compliance programs and activities. This leader helps promote an organizational culture that encourages compliance with laws and regulations and ethical conduct for all Baxalta employees and agents, and ensures that the CEO and Board of Directors are knowledgeable about the company's ethics and compliance program.

Education and Training

Baxalta's Global Code of Conduct requires compliance with laws, regulations and internal policies that govern how the company works. In order to reinforce the company's standards and help employees understand the policies and regulations, Baxalta offers compliance training for employees across a variety of topics and in various formats.

Compliance training enables employees to perform with integrity by helping employees understand the legal and regulatory implications of their actions. Baxalta provides risk-specific training to appropriate employees, reinforced with guidance from compliance staff and other resource guides to facilitate compliance.

Baxalta maintains e-learning programs discussing antitrust, preventing discrimination, export controls, federal government ethics, global privacy principles, trade compliance, HIPAA, healthcare fraud and abuse, data integrity, electronic media use, and Foreign Corrupt Practices Act, among others. Making courses available electronically, in multiple languages, makes them more accessible to more employees, improves productivity and fosters consistency across the company. E-learning enables appropriate compliance training across the world to meet the ever-changing requirements of legislative and regulatory bodies. The training content is evaluated and updated periodically to ensure it remains relevant and current.

E-learning complements training efforts in other areas such as good manufacturing practices, environment, health and safety, and quality. The goal is to give Baxalta employees the understanding and tools needed to comply with all necessary laws and regulations wherever they are based and wherever Baxalta does business.

Ethics and Compliance Communications and Investigations

5.1 Communications and Reporting

Baxalta strives to develop a culture that produces conscientious and ethically-minded employees who are committed to integrity, honesty, openness and fairness. If Baxalta is to be successful, employees must be able to openly communicate and ask questions regarding Baxalta's Global Code of Conduct. To support this concept, Baxalta has established the following resources.

The Compliance Decision Framework – 3P Test – helps employees think through situations to decide on the most appropriate course of action, consistent with Baxalta's Global Code of Conduct, values and expected behaviors. The questions within the 3P test about purpose, perception and process can help employees predict whether or not actions will be appropriate and outcomes positive.

Baxalta has a number of resources available for those who are seeking information about, or guidance on, the company's Global Code of Conduct or, who wish to report a potential violation of the standards. This process encourages employees, as a first step, to seek out local management or other resources for assistance in handling their inquiry. Alternative contacts are available to employees, including Regional Compliance Counsel, the Ethics & Compliance team or Corporate Responsibility Office resources.

Baxalta's Ethics & Compliance Helpline, a telephone and web resource, is available to employees, their families, suppliers and customers as another channel to report or seek guidance on issues. The Ethics & Compliance Helpline has the ability to connect counselors 24-hours a day, seven days a week in almost any language: www.baxalta.com/compliance.

The Ethics & Compliance Helpline is an independent channel of communication to raise issues and open communications about Baxalta's ethics and compliance issues. Employees, customers, suppliers and other Baxalta constituencies may use this communication vehicle to seek guidance, discuss concerns or report issues relative to Baxalta's Global Code of Conduct. Persons calling the Ethics & Compliance Helpline may choose to remain anonymous.

5.2 No Retaliation Policy

Baxalta employees may never punish or retaliate against anyone for raising a good-faith question or concern about compliance with policy or legal requirements. Baxalta enforces a non-retaliatory environment, making it safe for employees and other stakeholders to raise ethics and compliance concerns in good faith. Baxalta’s non-retaliation policy is actively supported by Baxalta’s senior management and is strictly enforced.

5.3 Investigations

Upon receipt of reasonable indications of suspected noncompliance, the Ethics & Compliance department, along with the management team, as appropriate, will investigate the allegations to determine whether a material violation of the applicable laws, regulations or policies has occurred, and if so, take appropriate steps to correct the problem.

Monitoring and Auditing

Baxalta’s Ethics & Compliance team is responsible for prioritizing, commissioning and conducting compliance assessments and audits to evaluate and assist in ensuring compliance with applicable legal, regulatory, and industry requirements, Baxalta policies, control and process requirements and ethical standards. These are conducted with the assistance of internal resources, such as Corporate Audit, and external resources, such as outside counsel and external auditors.

The Ethics & Compliance team is also responsible for the design and implementation of the company’s compliance monitoring program which includes some ongoing compliance testing performed by business and country management.

Enforcing Standards/ Hiring and Disciplinary Action

Baxalta is committed to hiring a workforce whose actions reflect a high degree of integrity and ethics. Accordingly, Baxalta makes efforts to conduct strict background checks on potential employees and is developing other measures to ensure that it does not employ or do business with persons or organizations that have been excluded, debarred, suspended or are otherwise ineligible to participate in Federal healthcare programs. Baxalta has committed significant resources in hiring highly qualified and skilled individuals. Additionally, Baxalta requires all new hires to receive and sign its Global Code of Conduct.

If after all investigations of potential wrongdoing are completed, any employee who is in intentional and material violation of applicable laws, rules, regulations or corporate policies will be subject to appropriate disciplinary corrective action up to and including termination. Although each situation is evaluated on a case-by-case basis, Baxalta consistently undertakes appropriate disciplinary action to address inappropriate conduct and deter future violations.

Correction and Preventative Action

Baxalta is committed to preventing and detecting violations of law or internal policies and procedures and taking appropriate corrective actions as necessary. Baxalta's ethics and compliance program is designed to ensure that potential violations of law or company policy are responded to promptly, appropriate disciplinary action is taken, and evaluation is given to prevent future violations.

Declaration

As of July 1, 2015, Baxalta US Inc. hereby declares that it is in substantial compliance with both its own compliance program as well as CA SB 1765. Since compliance is best achieved through ongoing efforts; Baxalta continues to develop, review and periodically enhance its many ongoing compliance programs. A copy of this document and/or Baxalta's written declaration of compliance can be obtained by calling Baxalta Connect at 1-844-229-2582 (1-844-BAXALTA) in the U.S.

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