Pursuant to the Consumer Product Safety Improvement Act (CPSIA), manufacturers of imported or domestically manufactured (U.S.A.) prescription drug products that are subject to a consumer product safety rule, ban, standard or regulation enforced by the U.S. Consumer Product Safety Commission (CPSC) are required to provide General Certificates of Conformity (GCC).

Takeda manufactures prescription drug products that are governed under the CPSC regulations. The Takeda GCC certifies that the product (the child-resistant package) complies with the Poison Prevention Packaging Act (PPPA) requirements for special packaging under 16 CFR § 1700.

The GCCs are maintained to reflect additions of new products and existing product changes. Please see CPSC regulations for further information and see product-specific GCC listings below.

ACTOS®, ACTOPLUS MET® and DUETACT® are registered trademarks of Takeda Pharmaceutical Company Limited.

COLCRYS® is a registered trademark of Takeda Pharmaceuticals U.S.A., Inc.

DEXILANT® and the DEXILANT Logo® are registered trademarks of Takeda Pharmaceuticals U.S.A., Inc.

KAZANO® is a registered trademark of Takeda Pharmaceutical Company Limited.

NESINA® is a registered trademark of Takeda Pharmaceutical Company Limited.

OSENI® is a registered trademark of Takeda Pharmaceutical Company Limited.

PREVACID® is a registered trademark of Takeda Pharmaceuticals U. S. A., Inc.  

ROZEREM® is a registered trademark of Takeda Pharmaceutical Company Limited.

TRINTELLIX® is a registered trademark of H. Lundbeck A/S and used under license by Takeda Pharmaceuticals America, Inc.

ULORIC® is a registered trademark of Teijin Kabushiki Kaisha (Teijin Limited), used under license.

Ethical Participation in Federal Health Care Programs

Takeda is committed to being a lawful, compliant, and ethical participant in the federal health care programs. Many federal and state laws, regulations, and other legal requirements, including the federal False Claims Act, have been created to prevent and help detect fraud, waste, and abuse in federal health care programs.

Takeda complies with any such applicable requirements in full, and has developed various policies and procedures for detecting and preventing fraud, waste and abuse. Takeda maintains a Corporate Ethics & Compliance program, which includes a Code of Conduct, policies and procedures for detecting and preventing fraud, waste and abuse, a monitoring program and a Compliance Hotline/Helpline. Please contact Ethics & Compliance for more information at [email protected].

Takeda is a global, values-based, R&D-driven biopharmaceutical leader with a large U.S. presence. We connect to our 240-year-old history and Japanese heritage through everything we do. Our unwavering commitment to putting patients first guides our scientific discovery and helps us as we strive to address unmet medical needs. As Takeda’s U.S. operations are integral to our global business, it’s important for Takeda to have appropriate engagement opportunities with U.S. policymakers and policy influencers.

The U.S. government accounts for nearly half of all U.S. health care spending, and its policies, legislation, and regulations impact the entire health care system. In order to ensure that Takeda’s point of view is considered by policymakers in critical debates affecting our products and therapeutic areas, we must provide a regular stream of information over time to educate elected officials on both sides of the aisle.

Lobbying Activities

Elected officials have an impact on public policy issues affecting Takeda and the patients we serve. We believe that public policy engagement is an important and appropriate role for companies when conducted in a legal and transparent manner. In the U.S., there are important federal and state lobbying registration and disclosure laws with which Takeda complies.

Where required, Takeda reports lobbying activity at state and federal levels. Takeda files quarterly lobbying reports that capture federal lobbying activity in the Congress and with any federal agencies. Takeda’s reports can be found by searching the Congressional lobby disclosure website.

Trade Associations

Takeda is a member of several industry and trade groups that represent both the pharmaceutical industry and the business community at large in an effort to bring about consensus on broad policy issues that can impact Takeda’s business objectives and ability to serve patients. Takeda’s participation as a member of these various industry and trade groups comes with the understanding that we may not always agree with the positions of the larger organization and/or other members, and that we are committed to voicing our concerns as appropriate through our colleagues who serve on the boards and committees of these groups. We disclose our current memberships in the U.S. where annual dues are more than $25,000.

Political Contributions

In the U.S., Takeda is committed to supporting candidates of any party using fair and objective criteria in the selection of candidates − including those who support public policies that contribute to the health needs of our patients, pharmaceutical innovation, and the interests of our company. This support comes from two different sources: Takeda’s Political Action Committee (TakPAC) and from corporate funds where legally allowed.

TakPAC is a separate, segregated fund registered with the Federal Election Commission and connected to Takeda Pharmaceuticals America, Inc. as a Lobbyist/Registrant PAC. The purpose of TakPAC is to provide monetary contributions and other support to candidates for federal, state, and local offices. Employee participation in TakPAC is completely voluntary, all contribution guidelines are only suggestions, and employees are free to contribute more or less than the guidelines or nothing at all. Takeda will neither favor nor disadvantage any employee by reason of the amount of his or her contribution or decision not to contribute. Employees may refuse to contribute without reprisal.

TakPAC activity reports are filed monthly with additional reporting requirements during an election year. TakPAC’s reports are available on the Federal Election Commission’s website, and a list of all PAC contributions is included in the TakPAC Annual Report:

• 2023 TakPAC ANNUAL REPORT
• 2022 TakPAC ANNUAL REPORT
• 2021 TakPAC ANNUAL REPORT
• 2020 TakPAC ANNUAL REPORT
• 2019 TakPAC ANNUAL REPORT

In some states, corporations are allowed to give directly to candidates in accordance with state campaign finance law. Takeda chooses to make contributions in some of these states, and discloses these contributions annually:

• TAKEDA’S 2023 CORPORATE CONTRIBUTIONS
• TAKEDA’S 2022 CORPORATE CONTRIBUTIONS
• TAKEDA’S 2021 CORPORATE CONTRIBUTIONS
• TAKEDA’S 2020 CORPORATE CONTRIBUTIONS
• TAKEDA’S 2019 CORPORATE CONTRIBUTIONS

Open Payments Act

Takeda is committed to improving health for people worldwide through innovation in medicine. We recognize the important contributions of valuable insight, expertise, and feedback that health care professionals ("HCPs") provide to us in support of this mission.

Section 6002 of the Patient Protection and Affordable Care Act, commonly known as the Open Payments Act or the Sunshine Act, requires pharmaceutical manufacturers, including Takeda, to track “transfers of value” provided to actively-licensed U.S. HCPs and Teaching Hospitals (collectively described as “Covered Recipients”) and to submit an annual report detailing such transactions to the Center for Medicare and Medicaid Services by March 31st each year for the prior calendar year.

Report Information

It is helpful to understand that there are two reporting submission templates provided by the Centers for Medicare and Medicaid Services (CMS) for reporting transfers of value under the Open Payments Act: General Payments and Research Payments. Takeda will report transfers of value in these areas based on the type of interaction conducted with Covered Recipients and the statutory definitions. Transfers of value to Covered Recipients that do not meet the Open Payments Act definition of Research will be submitted on the General Payments template with a corresponding payment nature per the statutory requirements.

For 2021 spend, Takeda is required to report transfers of value to Covered Recipients provided by, or on behalf of, Takeda, including fees/reimbursable expenses that are individually greater than $11.05 or cumulatively greater than $110.40.

It is important to note that Research payments will appear as aligned both with the entity receiving the payment and the principal investigator(s) for the clinical trial.

Some additional examples of reportable transfers of value are listed below:

• Professional Services: Including payments for advisory boards, consulting services, or promotional speaking
• Educational Materials: Including certain reference materials such as journal articles and textbooks
• Business Meals: Including Takeda-provided or reimbursed meals in conjunction with professional services or recruiting
• Business Travel: Including Takeda provided or reimbursed amounts for transportation (e.g., airfare, hotel, taxi)

Collaboration

Takeda values working with Covered Recipients and we believe such collaboration is critical to deliver better health and a brighter future to patients we serve.

Additional Information about Open Payments

To learn more about the Open Payments Act, please visit the CMS website.

Questions

If you have any questions concerning this matter, please do not hesitate to contact us at [email protected].

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.

You can view our California Annual Comprehensive Compliance Program Declaration by clicking the button below.

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