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Our Policies

How we uphold ethics, safety, and purpose.

Keenova's Code of Conduct defines how we interact with patients, healthcare providers, payors, suppliers, government officials, the healthcare community, and our colleagues. It is designed to enable team members to apply the principles of respect, trust, and integrity to their day-to-day activities. All team members, full-time contractors, and select part-time contractors and vendors are required to complete annual training on the tenets of the Code of Conduct and certify that they will adhere to it.  
 
Keenova's full Code of Conduct is located below, available in multiple languages.   
 
English
French Canadian 
Japanese 

Keenova’s public policy engagement focuses on building a constructive discourse in the political and regulatory environment to further the company’s interests and the innovation ecosystem and to enhance our ability to meet patient needs. For this reason, the company actively engages in dialogue with policymakers to explain and advocate its perspectives. Keenova’s political and lobbying activities (including contributions made by the Keenova Political Action Committee) take place without regard to the personal preferences or affiliations of team members, officers, directors, customers, or vendors. Keenova’s public policy initiatives are subject to robust oversight, designed to comply with applicable law(s), and exclusively consider the company’s interests. Keenova’s Code of Conduct outlines the process for team members who engage with government officials on behalf of Keenova to influence official action.

In accordance with applicable law, Keenova exclusively makes political contributions from the Keenova PAC, a nonpartisan organization that provides opportunities for team members to participate in the American political process. The Keenova PAC makes contributions to candidates and office holders at both the federal and state level and discloses its contributions to the Federal Election Commission (on Form LD-2) and appropriate state authorities. Contributions by team members to the Keenova PAC are entirely voluntary. Keenova will neither favor nor disfavor team members based on such contributions. 

Corporate contributions are also made in states where permissible and disclosed according to local rules and regulations. 

Keenova’s Board of Directors is apprised of political and lobbying policies, procedures, and key initiatives.

Keenova is committed to conduct business ethically, lawfully and with integrity in the global marketplace. It includes compliance with the U.S. Foreign Corrupt Practices Act 1977 (“FCPA”), the UK Bribery Act (“UKBA") and other anti-bribery and anti-corruption laws. While determining whether an activity is covered by these laws can be complicated, the underlying principle at Keenova is simple: do not bribe or offer to bribe anyone, or solicit or accept a bribe from anyone, at any time, for any reason whether it’s done directly or through third parties intermediaries. Keenova holds its business partners to the same ethical standards.

Keenova hereby declares that to the best of our knowledge and based on our good faith understanding of the statutory requirements, we have established a Comprehensive Compliance Program (CCP) for our U.S.-based operating companies that is compliant with the requirements set forth by the California Health and Safety Code §§ 119400-119402. By making this declaration, Keenova is not asserting that in all circumstances we can prevent individual employees from engaging in conduct that deviates from the standards set forth in the CCP, but we have established procedures to identify potential violations and to address inappropriate conduct as necessary. In addition, Keenova assesses its CCP on an ongoing basis and makes enhancements as necessary.

The California Transparency in Supply Chains Act of 2010 (SB 657) requires certain companies doing business in the state to provide consumers with information regarding its efforts to address the issues of slavery and human trafficking within their direct supply chain(s). 

Keenova and its affiliates are committed to conducting business in a lawful and ethical manner. We do not tolerate human rights abuses within our own business operations and we expect all of our business partners, including suppliers, to engage in sound human rights practices, to treat workers fairly and with dignity and respect. Keenova fully supports the intent of California's law and opposes slavery and human trafficking in all forms.  
 
Keenova engages in an internal assessment process for evaluating and selecting suppliers. Our contractual agreements include provisions requiring suppliers to comply with all applicable laws and regulations as relates to the products or materials supplied, including labor, employment, slavery, and human trafficking laws. Keenova conducts audits for compliance with applicable laws and regulations and failure to comply with these requirements are grounds for business relationship termination.  

In cases where a clinical trial isn’t an option and the patient has exhausted all available treatment options, regulators may grant permission for us to provide a treating physician with an unapproved drug. Such individual use of an unlicensed investigational drug is often called “compassionate use” or “expanded access” but may go by other names. 
 
It's important to remember that investigational drugs have not received regulatory approval; therefore, their potential risks and benefits are not yet established. Doctors and patients should consider all possible risks and benefits when seeking compassionate or expanded access to a product that is unapproved for the condition in which the patient and physician are seeking treatment. 
 
While an expanded access program (EAP) is not opened for every investigational treatment or use, our company does not offer EAPs when investigational medicines are in early testing because there are still too many unknowns. 
 
To be eligible for access to an investigational or unlicensed product, patients must meet the following criteria: 
 
- Suffer from a serious or immediately life-threatening disease or condition 
- Have undergone appropriate standard treatments without success, and comparable or satisfactory alternative treatments to diagnose, monitor or treat the disease or condition are not available 
 - Are ineligible for participation in any ongoing clinical study of the investigational drug and do not meet any other pertinent medical criteria for access to the investigational or unlicensed drug, as established by Keenova

  
Please feel free to contact us with any questions: 
 
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Keenova has a comprehensive process to comply with the reporting and disclosure related to conflict minerals, as directed by the Dodd-Frank Wall Street Reform and Consumer Protection Act, which requires manufacturers who are SEC filers to disclose whether the products they manufacture or contract to manufacture contain conflict minerals that are "necessary to the functionality or production" of those products. The intent of these requirements is to further the goal of ending violent conflict in the Democratic Republic of the Congo (DRC) and in adjoining countries, which has been financed, in part, by the exploitation and trade of conflict minerals. 
 
Conflict minerals refer to tin, tantalum, tungsten and gold (commonly referred to as 3T&G), regardless of where they are sourced, processed or sold. 
 
In line with the rule, Keenova is specifically: 
 
1. Using the Organization for Economic Co-operation and Development’s (OECD) Due Diligence Guidance as the international framework for meeting the sourcing expectations of our customers, regulators and stakeholders 
2. Strengthening its due diligence capabilities and processes to identify the source of minerals used in Keenova's products—we further expect the support of our suppliers in determining the country of origin of the minerals used in our products 
3. Committed to improving, over time, our ability to track and trace conflict minerals in our supply chain 
 
Keenova must rely on its suppliers' cooperation in the implementation of and adherence to this policy in order to meet its obligations to the SEC. Our specific expectations of suppliers include a timely response to our queries about purchased components, assistance in reaching out to their suppliers in case the source of minerals is not currently known, and regular communications with Keenova about suppliers' conflict mineral tracking and tracing efforts.

On March 3, 2022, legacy company Mallinckrodt plc entered into a civil settlement with the federal government and U.S. states and territories to resolve certain government investigation and litigation matters. As part of the settlement, Mallinckrodt entered into a Corporate Integrity Agreement (CIA) with the Department of Health and Human Services Office of Inspector General. Through the CIA, Mallinckrodt, and now Keenova, has been taking guidance from an Independent Review Organization’s reviews and working with our government-assigned compliance monitor to ensure we are meeting the high ethical standards to which we are committed.

Keenova provides equal employment opportunities to applicants and employees without regard to race; color; gender; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; protected veteran status; disability; or any other category protected by law.

Keenova team members play an important role in the healthcare system. Our relationships with healthcare professionals are intended to inform them about the benefits and risks of our products to help advance appropriate patient use, provide scientific and educational information, support medical research and education, and obtain feedback and advice about our products through consultation with medical experts. Keenova is committed to achieving its business and scientific objectives in an ethical and compliant manner. 
 
Read more in our Code of Conduct

As required by the Ireland Gender Pay Gap Information Act 2021, we report our gender pay metrics for team members in Ireland, including salary, bonus, and benefit distributions across employment categories and pay quartiles. See below for our most recent report. The gender pay gap required by this reporting is different from pay equity. The company does not make pay decisions based on gender or any other characteristic protected by applicable law. 

The Keenova Supplier Code of Conduct outlines the expectations for the ethical behavior of our suppliers and prohibits child and compulsory labor, human trafficking and slavery, unsafe and hazardous working conditions and environments, and any behavior that does not maintain human dignity and respect. These standards apply to all suppliers of goods and services to any Keenova business or supplier, regardless of location. 
 
Canada Modern Slavery Act Disclosure
UK Modern Slavery Act Disclosure

Keenova participates in the American Medical Association (AMA) Prescription Data Restriction Program (PDRP) in order to comply with state laws regarding the use of their prescription data as well as the requests of healthcare professionals who choose for their prescription data to be restricted. The PDRP allows healthcare providers the opportunity to restrict their prescribing data from pharmaceutical sales representatives and/or not be used for marketing purposes. Healthcare providers may request to have their prescription data restricted by registering at American Medical Association's Physician Data Restriction Program website.

All suppliers working with or on behalf of Keenova are expected to share our commitment to ethically, socially, and environmentally responsible operations and abide by the Pharmaceutical Supply Chain Initiative (PSCI) guidelines, which serve as the foundation for our own Supplier Code of Conduct (“Supplier Code”). We hold our suppliers accountable and evaluate suppliers based on the principles contained in the Supplier Code. 

Read more in our Supplier Code of Conduct

Following the requirements of the federal “Transparency in Coverage” rule, Keenova displays pricing data for covered items and services based on in-network negotiated payment rates and historical out-of-network allowed amounts. The Machine Readable File is intended to be analyzed by third parties to conduct research and develop products to help consumers better understand the costs associated with their healthcare and evaluate their healthcare coverage options.

A subsidiary of Keenova is subject to a Voluntary Operating Injunction (the VOI) governing the remaining U.S. opioid business. The terms included the appointment of a corporate monitor who oversaw, reported on and made recommendations regarding compliance with the VOI through April 23, 2024. The monitor’s reports are available below. 
 
Initial Independent Monitor’s Report - March 16, 2023 
Final Independent Monitor’s Report - April 19, 2024