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About Kaléo

Kaléo is a global leader in drug-delivery device technology and auto-injector innovation, providing millions of patients with security and peace of mind.

Two people working

Founded with Purpose

nurse-with-child

Kaléo is derived from the Greek word for “a calling” or “purpose” and reflects the shared mission of the Kaléo team to empower patients and healthcare providers with innovative, life-saving solutions.

Our journey began twenty years ago, inspired by the personal passion of our founders to overcome the limitations of anaphylaxis rescue medications. Their personal experiences inspired them to develop a better solution that has led to a growing portfolio of drug-device combinations designed to deliver lifesaving and enhancing treatments with precision and reliability.

This commitment drives us to set the highest standard of being purposefully precise as we aim to improve quality of life and strengthen global health security.

The Kaléo Mission

At Kaléo we are united by a shared desire to redefine what is possible in medical technologies, creating innovative solutions that deliver protection from medical threats and help provide peace of mind to those who rely on us. We never compromise on quality and are steadfastly focused on being best-in-class. Our goal is to deliver superlative results for our patients, partners, investors, and our dedicated employees.

A Culture Rooted in Principles and Action
Our company values define who we are and how we work, guiding our decisions and shaping our relationships.

Together, they reflect our Vision:
To be the world leader in medical technologies, specializing in drug-device combinations that improve quality of life and enhance global health security.

Leadership

Our Leadership Team drives progress with a focus on innovation and a commitment to our mission. With deep industry experience and a strong emphasis on patient safety, they inspire us to improve and protect lives.

Michael Wells

Chairman & Chief Executive Officer

Ted Marcuccio

Chief Business Officer
Theresa Matkovits

Theresa Matkovits, Ph.D.

Chief Development Officer

Chuck Nicholls

Chief Manufacturing and Supply Chain Officer

George Parise

Chief Financial Officer

Alfred Tenuto

Chief Commercial Officer

Tina Thompson

Chief Compliance Officer
Vice President, General Counsel

Steve Gaeth

Vice President
Controller

Mark Herzog

Senior Vice President
Global Health Security

Matthew Simmons

Vice President
Finance and Strategic Planning

Michael Roe, PE

Vice President
Development
David Smiy

David Smiy

Vice President
Market Access

Board of Directors

Michael Wells

Chairman & Chief Executive Officer

Evan Bedil, MD

Member, Kaléo Board of Directors
Managing Director, Head of Healthcare, Marathon Asset Management

Susan Graf

Member, Kaléo Board of Directors
Senior Advisor to Locust Walk

Major General Elder Granger, MD

Member, Kaléo Board of Directors

Randy Raisman

Member, Kaléo Board of Directors
Managing Director, Marathon Asset Management

Integrity & Compliance

At Kaléo, integrity is built into everything we do. We are driven to create innovative healthcare solutions to meet the needs of patients and partners who rely on our drug delivery devices.

Office workers

This responsibility requires that all users of our auto-injectors have trust in Kaléo. We recognize that good intentions and hiring good people are not enough. Building and maintaining trust is a daily practice for all Kaléo employees.

Appropriately, the pharmaceutical industry is highly regulated by the United States and other governments. Regulating industries that can directly impact people’s lives and health is necessary. We respect those who seek to protect patients and improve patient outcomes.

Government regulations inform the development, manufacturing, and commercialization of Kaléo products. There are also regulations that inform how we support our products and conduct ongoing safety monitoring. It is our expectation that Kaléo employees exceed these laws and regulations. To be a trusted company, we commit to demonstrating integrity in all that we do.

To support our Kaléo community in understanding this guidance, we have implemented an Integrity & Compliance Program (“The Program”). The Program consists of key elements that Inform, Support, Monitor, and Enhance compliance with Kaléo and external requirements.

Kaléo’s Integrity & Compliance Program

The primary focus of the Integrity & Compliance Program is on daily interactions with the healthcare community. The Program described below works jointly with Kaléo’s Quality Program, which provides similar support for the development and manufacturing of Kaléo’s products.

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Inform

The Program informs compliance through the development of policies, procedures, and work instructions. The principles in our policies inform what our standard is on a given requirement. The principles are intentionally connected to our values and how leadership believes we can best demonstrate our integrity. The procedures and work instructions inform how we can appropriately and effectively implement the requirements. We leverage various training approaches (e.g., computer-based training, live group events) that embrace adult learning principles to further inform what is required and how we most effectively implement them.

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Monitor

Policies inform staff of key requirements. Processes are intended to maximize efficiencies and ensure compliance with requirements. Monitoring of key requirements and process compliance occurs in two ways. First, the business monitors numerous processes they own or engage. In addition, independent monitoring is performed by teams outside of the processes. The Integrity & Compliance team consolidates and assesses monitoring efforts. Using advanced data analytics, the results are shared on a quarterly dashboard, providing leaders with actionable data to improve performance.

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Support

The Program support begins with each employee at Kaléo. Compliance is not owned by a department but is a commitment made by each employee. As a result, our leadership must provide valuable coaching, evaluation and support in meeting the Kaléo requirements. The Program provides valuable leadership training and tools to support their efforts. Our leaders create an environment that helps their teams be successful, including being compliant with Kaléo requirements. They offer support and hold each employee accountable to being their best self, which includes demonstrating integrity.

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Enhance

There are numerous feedback loops that inform ongoing enhancements to The Program. In addition to monitoring activities, local leadership teams and the Compliance Committee can inform improvements. Investigations into alleged non-compliance include a root cause analysis that may inform improvements in process and training. The Program staff also commit to developing their professional skills, which includes benchmarking best practices. Lastly, The Program conducts listening sessions of various employee groups to inform program improvements.

Feedback & Concerns

We are hopeful that we have created an expectation for how Kaléo will operate ethically. At Kaléo, we strive to be our best selves every day and whatever we do, to do well. If ever you observe any member of the Kaléo team, or our partners, fall short of your expectations, please contact us.

Contact the Integrity & Compliance Team Directly

Employees, members of the healthcare community, and others are encouraged to contact Kaléo’s Integrity & Compliance team directly with any questions or concerns related to Kaléo, its parents, affiliates, or subsidiaries.

Please contact us directly to talk or to schedule a live appointment at compliance@kaleo.com.

If preferred, a member of the team will also speak live to address feedback and concerns. Please email the above address to arrange a time to speak live.

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Contact the Kaléo Helpline

The Kaléo Helpline is always available for anyone to contact the company about a concern related to Kaléo, its parents, affiliates, or subsidiaries or to get information.

You can call (877) 338-3039 or visit lighthouse-services.com/kaleopharma.

The Compliance Helpline is administered by an independent outside contractor to allow confidential and anonymous reporting. Though not required, those who contact the Helpline are encouraged to leave a name and phone number in case additional information is needed.

Kaléo Helpline