Partners, Programs, and Promises

Common goals build strong relationships. In keeping with our commitment to research and development, medical advancement, and social responsibility Takeda has focused on being a good corporate citizen to the communities where its employees and patients live and work.

Partners in Social Responsibility

Among our active partners in education, prevention, and advocacy are:

• The American Diabetes Association
• American Heart Association
• American Cancer Society

Partners in our Communities

Supporting the next generation of innovators starts with a commitment to supporting science education, advocacy, and healthy lifestyles. Takeda's partners in this commitment include Girls on the Run-Chicago, a non-profit organization that educates girls on the benefits of a healthy lifestyle, and Midtown Educational Foundation, which promotes the educational and personal development of Chicago's inner-city youth. We also support the Achievement Rewards for College Scientists Foundation, the largest science scholarship program in the nation and Young Women's Leadership Charter School in Chicago, which emphasizes math, science and technology education for women. In addition, Takeda contributes to the American Cancer Society’s Summer High School Research Program which gives students in the Chicago-area the opportunity to gain valuable hands-on experience in a scientific research setting, and to broaden their understanding of the impact of cancer on the population.

The Takeda Matching Gift Program supports individual Takeda employee contributions to non-profit organizations. Takeda employees at all levels contribute countless volunteer hours each year; serving on boards, acting as mentors, and rolling up their sleeves to take part in community activities. We acknowledge their exceptional efforts to give back and coordinate an annual Takeda Community Outreach Day. Since 2003, Takeda has partnered with Rebuilding Together, a national non-profit organization that coordinates rehabilitating activities for this event. Each year, we identify a local school in need of painting, landscaping and refurbishing and invite employees to leave the office for the day to give back to their community.

Patient Assistance

We believe everyone deserves access to life-changing medicines. Takeda is proud to offer a patient assistance program for eligible individuals.

Request a Patient Assistance application and read a detailed description of the terms and conditions of participation.

Informaciόn sobre el Programa de Asistencia al Paciente de Takeda Pharmaceuticals America, Inc.

Patient Assistance Program for Prevacid.

Our Promise of Ethics and Compliance

Takeda employees work together to build an organization based on integrity, so each interaction and each decision has this important foundation.

With integrity at the core of our decisions —and the culture of compliance that goes with it—this shapes who we are, the decisions we make, and the actions we take as Takeda employees. As part of the Program, we have adopted an Ethics & Compliance Policy that makes all Takeda employees and agents responsible for conducting their business activities in compliance with all applicable laws and regulations, all applicable policies and procedures, and the highest standards of business ethics. The purpose of our Corporate Ethics & Compliance Program and our Ethics & Compliance Policy is to prevent and detect violations. To report a suspected violation please call 1-888-TAKEDA-0 or make an on-line report by clicking this link MyComplianceReport.com and using the access code TAKEDA.

The Ethics and Compliance Policy is aligned with the OIG Compliance Program Guidance for Pharmaceutical Manufacturers and consistent with the PhRMA Code on Interactions with Healthcare Professionals.

1. Written Policies & Procedures

Our company Code of Conduct, Compliance Guidelines, and other policies and procedures are tangible expressions of our culture of compliance. These documents guide and instruct Takeda personnel in the conduct of our day-to-day activities. The Code of Conduct and Compliance Guidelines express Takeda’s commitment to:

• Preventing illegal or unethical behavior; and
• Taking corrective action should such behavior occur.

The Code of Conduct is a statement of Takeda’s policies and procedures for conducting its business in accordance with applicable laws and the highest ethical standards. The Code contains the business and ethical policies that Takeda expects its management, employees, and agents to follow.

The Compliance Guidelines set forth the ethically appropriate manner in which Takeda personnel will interact with healthcare professionals. This document reflects the company’s commitment to the principles set out in the PhRMA Code on Interactions with Healthcare Professionals.

Takeda also has developed policies and procedures identifying appropriate conduct in the three primary risk areas for pharmaceutical companies identified in the OIG Guidance, including, (1) data integrity pertaining to government reimbursement practices; (2) kickbacks and other illegal remuneration; and (3) compliance with laws regulating drug samples. These include the company’s Compliance Guidelines as well as Standard Operating Procedures (SOPs) pertaining to government price calculations and sample accountability.

We also have established a specific annual dollar limit of $2,500.00 on spending for gifts, promotional materials, and items or activities provided to healthcare professionals, as required by California law. While we are committed to not exceeding this amount, the establishment of this limit does not mean that we spend this amount on all healthcare professionals. To the contrary, the California law requires the establishment of a maximum dollar limit and, therefore, very few of the healthcare professionals with whom we interact approach this limit.

2. Leadership & Oversight

Takeda has established its Office of Ethics & Compliance (OEC) to lead the company’s compliance efforts. The OEC is responsible for developing, implementing, and continuously improving Takeda’s Corporate Ethics & Compliance Program. Takeda is committed to ensuring that the OEC has the ability to effectuate necessary and appropriate change within the company and to exercise independent judgment. The director of the OEC reports to Takeda’s president.

The OEC works closely with Takeda’s Ethics & Compliance Committee in shaping the company’s Corporate Ethics & Compliance Program. The mission of Takeda’s Ethics & Compliance Committee is to provide advice and oversight in the development, implementation, and continuous improvement of this Program. The Ethics & Compliance Committee consists of a number of Takeda’s senior management personnel, including Takeda’s president and the heads of the Law, Marketing, Sales, and Medical & Scientific Affairs departments, which bring to the Committee a variety of skills and personality traits, as well as the authority to push compliance initiatives into their respective functions.

3. Training & Education

Training and education are critical features of Takeda’s Ethics & Compliance Program. We firmly believe that when provided with the proper tools and information, Takeda employees will conduct their activities in a manner consistent with our culture and the law. Takeda is committed to taking the necessary steps to effectively communicate our compliance policies and procedures to all employees.

New employees in both the Home Office and the field receive initial training and tenured employees receive annual refresher training on Takeda’s Code of Conduct and Compliance Guidelines. We employ a mix of instructor-led and computer-based training that is example based to provide employees with real world scenarios to which to apply Takeda’s policies. Takeda employees also receive training that is specific either to their particular roles—for example, sample accountability training for sales representatives involved with the distribution of samples—or to a particular topic area—for example, records retention.

4. Lines of Communication

Employees are encouraged to take advantage of Takeda’s open-door policy when it comes to raising compliance questions and discussing potential compliance concerns. Managerial personnel are available to respond to these questions and concerns, as is the Office of Ethics & Compliance. If an employee does not feel comfortable talking with their manager, they also may contact the Office of Ethics & Compliance, either directly or through the Takeda Compliance HelpLine. Reports to the HelpLine may be made anonymously. Upon receiving a report, the OEC, in conjunction with other relevant functions, will follow up to ensure appropriate resolution.

Takeda is committed to its policy of not retaliating against personnel who make good faith reports of potential compliance issues. This policy is expressed in Takeda’s Ethics & Compliance Policy, Code of Conduct, and Compliance Guidelines.

5. Monitoring & Auditing

The Office of Ethics & Compliance engages in ongoing monitoring and auditing to evaluate the existence of appropriate policies and procedures, the implementation and communication of such policies and procedures, and compliance with such policies and procedures. In accordance with the OIG Guidance, the nature, extent, and frequency of the reviews Takeda conducts varies according to factors such as new regulatory requirements, changes to Takeda’s business practices, or identified high-risk areas.

In addition to the company’s auditing and monitoring activities—including activities involving the company’s fee-for-service engagement of physicians and provision of grant funds—Takeda employees at all levels are responsible for reporting potential compliance issues of which they become aware. Both the Code of Conduct and the Compliance Guidelines expressly highlight this responsibility.

6. Disciplinary Policies

Takeda is committed to having clear disciplinary policies to address situations where employees engage in illegal or unethical conduct. While conduct is evaluated on a case-by-case basis, the company will undertake disciplinary or corrective action in a consistent manner so as to ensure that such action is appropriate under the circumstances and has the intended deterrent effect. Penalties for compliance violations may include termination, depending upon the seriousness of the violation.

7. Investigation & Corrective Action

Takeda’s Ethics & Compliance Program is designed to create a culture of compliance and to help prevent the likelihood of the occurrence of illegal or unethical behavior. As recognized in the OIG Guidance, no compliance program can prevent all occurrences of misconduct by individuals. However, Takeda’s Ethics & Compliance Program is reasonably designed to prevent and detect violations.

The Code of Conduct and Compliance Guidelines both address the investigation of suspected violations of compliance policies. Upon receipt of reports or discovering information about a suspected violation of the Code of Conduct, Compliance Guidelines, or related policies and procedures, Takeda shall respond promptly, including, where appropriate, conducting an investigation to determine if a violation has occurred. If the company determines that a violation has occurred, it shall promptly take appropriate disciplinary and/or corrective action to help prevent similar violations in the future.

To further assist in preventing violations, the company screens individuals against the OIG exclusion list prior to making hiring decisions.

Takeda’s Compliance Mission

Takeda’s compliance mission boils down to one ideal—doing the right thing. At Takeda, we want to maximize our business opportunities, but we must always strive to minimize the risks associated with noncompliance. Takeda’s Corporate Ethics & Compliance Program is designed to help each and every one of us achieve this mission.

Accomplishing our Compliance Mission will ensure that we will continue to build Takeda’s reputation as a new kind of pharmaceutical company. To report a suspected violation please call 1-888-TAKEDA-0 or make an on-line report by clicking this link MyComplianceReport.com and using the access code TAKEDA.

Federal and state laws concerning false claims and statements and protections for those who raise compliance and certain other concerns

Effective January 1, 2007, a new federal law requires any entity that receives or makes annual Medicaid payments of at least $5 million to establish written policies for all of its employees, contractors or agents, regarding certain laws, employee rights and company policies. Takeda is providing this notice to you as a result of this new law. See Section 6032 of the Deficit Reduction Omnibus Reconciliation Act ("DRA") of 2005 (Pub. L. No. 109-171) amended Section 1902(a) of the Social Security Act.

Takeda is committed to being a lawful, compliant, and ethical participant in the federal health care programs. Many federal and state laws have been created to prevent and help detect fraud, waste, and abuse in federal health care programs. The following is a summary of some of these federal and state laws.

Federal False Claims Act

The Federal False Claims Act prohibits knowingly presenting (or causing to be presented) to the federal government (the "Government") a false or fraudulent claim for payment or approval. Additionally, it prohibits knowingly making or using (or causing to be made or used) a false record or statement to get a false or fraudulent claim paid or approved by the Government or its agents, like a carrier, other claims processor, or state Medicaid program. The Attorney General must investigate possible false claims violations and may bring a civil action if he or she determines that a violation is occurring or has occurred. A person who violates the False Claims Act is liable for damages up to three times the amount the Government is defrauded plus mandatory penalties of $5,500 to $11,000 for each false claim submitted.

An entity, or employees acting on its behalf, "knowingly" makes a false statement or claim if it actually knows that the statement or claim is false or it acts in "deliberate ignorance" of, or with "reckless disregard" for, whether the statement or claim is actually true or not. A key element of a False Claims case is that someone knowingly did something wrong, not just made an innocent mistake or error.

The False Claims Act contains qui tam provisions. Qui tam is an abbreviation for a Latin phrase dating back to 13th century England, meaning a person who sues for the king as well as for himself. Under the Act's qui tam provisions, a person with evidence of fraud, also known as a relator, is authorized to file a case in federal court and, on behalf of the Government, sue persons engaged in the fraud and to share in any money the Government may recover.

When a qui tam complaint is filed, the case remains under seal (i.e., it may not be disclosed) for at least 60 days. This 60-day seal period may be extended upon request by the Government. It is not unusual for the seal period to last a number of years. During the seal period, the Government will investigate the allegations of violations of the False Claims Act.

If the Government intervenes and proceeds with the action, the Department of Justice has primary responsibility for pressing the case forward in court. If the Government declines to intervene, the relator has the right to conduct the action on his or her own and must bear the cost of the suit as it proceeds.

Administrative Remedies

The Government also has other available mechanisms to address fraud and abuse, including administrative remedies such as recoupment of overpayments, program exclusions, and civil monetary penalties.

A person who makes a false claim or statement may be liable for a civil penalty for each such claim or statement, in addition to any other remedy available under law.

False Claim

A person is liable for administrative penalties for making a false claim where, among other things, he or she submits or causes to be submitted a claim that he or she knows or should know is:

• False, fictitious, or fraudulent; or

• Contains or is accompanied by a written statement that puts forth a material fact that is false, fictitious, or fraudulent.

False Statement

Similar to the false claims liability, a person is liable for submitting a false statement, where, for instance, he or she submits or causes to be submitted a written statement that:

• He or she knows or should know puts forth a material fact that is false, fictitious, fraudulent or leaves out a material fact and is false, fictitious, or fraudulent due to the failure to include the material fact;

• In instances where a material fact is omitted, the person submitting the statement had a duty to present the fact; and

• The submission includes an express certification or affirmation that the contents of the submission are true and accurate.

In addition to civil penalties and other remedies, program exclusions prevent individuals or entities from participating in the applicable federal programs under various circumstances.

State Laws

States have a variety of civil and criminal laws that may be used to control health care fraud and abuse. For instance, states may have a variety of laws in place to facilitate prosecution of Medicaid fraud, and some have established their own versions of a false claims act which offer certain protections for those raising concerns. States with false claims acts include: Arkansas, California, Delaware, the District of Columbia, Florida, Hawaii, Illinois, Indiana, Louisiana, Massachusetts, Michigan, Montana, Nevada, New Hampshire, New Mexico, Ohio, Tennessee, Texas, and Virginia. The list of States with false claims acts may not be exclusive. Call to Action: To learn more about the false claims act of any particular State, please visit the Centers for Medicare and Medicaid Services' Medicaid Fraud Statutes Web Site at www.cms.hhs.gov/apps/mfs/weblist.asp or, if you are a Takeda employee, you may visit Takeda's intranet Horizon. We incorporate the information from Takeda's website and CMS" website into this policy.

These statutes apply when a false claim is submitted to the state. Persons who violate these statutes may face substantial fines for each false claim submitted. Although most of these statutes are very similar to the Federal False Claims Act, some include provisions that diverge from the Federal False Claims Act, such as provisions imposing jurisdictional bars.

The Florida False Claims Act, for example, imposes liability on any person who engages in any one of a variety of actions that result in the submission of a false claim to the government for payment or approval, such as "knowingly present[ing] or caus[ing] to be presented to an officer or employee of an agency a false claim for payment or approval"; or "knowingly mak[ing], us[ing], or caus[ing] to be made or used a false record or statement to get a false or fraudulent claim paid or approved by an agency . . . ." Fla. Stat. Ann. ch. 68 § 68.082(2) (2006) An innocent mistake is a defense to a violation.

Protection For Those Raising Concerns

Those raising concerns regarding health care fraud and abuse may enjoy various protections against retaliation by their employers. The False Claims Act, for instance, provides a remedy for relators that are discharged, demoted, suspended, threatened, harassed, or otherwise discriminated against in retaliation for filing a False Claims Act suit. If a court finds a relator was terminated or otherwise retaliated against for filing a qui tam lawsuit, the employee is entitled to reinstatement at the same seniority level as if he or she had never left the company, in the case of a termination, and other relief.

Takeda Policies and Procedures

Takeda has various policies and procedures for detecting and preventing fraud, waste and abuse. These policies and procedures include Takeda's Corporate Ethics & Compliance Program Charter, Compliance Guidelines for Interactions with Healthcare Professionals and Customers, Code of Conduct and Compliance Helpline. Please visit www.tpna.com for more information. Takeda employees may also visit Takeda's intranet Horizon or contact the Office of Ethics & Compliance for more information.

State Compliance

Compliance with state law requirements is an important feature of Takeda's Ethics & Compliance Program. Click the links below for information relating to our state compliance efforts.

California

Vermont - ACTOS^®

Vermont - ACTOplus met™