Alkermes' Commitment to Integrity and Compliance

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NORTHAMPTON, MA / ACCESSWIRE / December 18, 2023 / Alkermes
Originally published in Alkermes September 2023 Corporate Responsibility Report

Ethics and Compliance

Integrity is a core Alkermes value and the foundation of the way we do business. Alkermes is dedicated to upholding legal, regulatory and ethical standards in the markets in which we operate and to maintaining a strong culture of compliance.

Our focus on compliance applies to all aspects of our business, beginning with preclinical research and continuing through clinical trials, manufacturing and commercialization. This focus on compliance helps to build trust with healthcare professionals, institutional purchasers, relevant government agencies and the public at large.

Compliance is a responsibility shared by all employees across all levels of the Company. We expect each employee to take an active role in supporting our culture of compliance and to perform all activities and conduct all interactions with integrity and in accordance with the highest ethical standards.

Our commitment to compliance is embodied in our comprehensive compliance program which is built on the following core elements:

Written policies and procedures that address the compliance risk areas relevant to pharmaceutical manufacturers, including those identified in the guidance of the Office of Inspector General of the U.S. Department of Health & Human Services (HHS) and the Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Healthcare Professionals.
The Company's Chief Compliance Officer oversees our compliance program and reports directly to the Company's CEO. The Company's Corporate Compliance Committee helps oversee the Company's compliance program and assists with identifying any compliance issues that may need to be brought to the attention of the Board.
Alkermes conducts extensive training and education programs for all employees that begin with new hire training and include regular, ongoing training on topics, processes and policies relevant to their positions.
Alkermes has established and continues to foster a culture of compliance that maintains effective lines of communication and encourages all employees to seek guidance on ethical or legal issues as they arise. This culture of compliance is further supported by a policy obligating employees to report possible compliance violations and a strong anti-retaliation policy (discussed below) that protects personnel who report issues in good faith.
Regular monitoring and auditing of the compliance program enables Alkermes to detect and prevent potential non-compliance.
The Company's policies and training ensure that all employees, including management, are informed of the consequences of failing to adhere to our compliance policies.
Our compliance program is designed to promptly respond to and address, through corrective action, any detected instances of non-compliance.

Code of Conduct

Our Code of Business Conduct and Ethics (Code of Conduct) applies to all employees, officers and directors of the Company. A current copy of the Code of Conduct is available on the Corporate Governance page of the Investors section of our website.

Among other things, the Code of Conduct requires:

Honest and ethical conduct by employees, officers and directors of the Company, including the ethical handling of actual, potential or apparent conflicts of interest;
Full, fair and understandable disclosure of the Company's activities in reports filed with the SEC and in the Company's other public communications; and
Prompt internal reporting of any violations of the Code of Conduct to a supervisor, the Company's Chief Legal Officer or the Company's Chief Compliance Officer (which role is currently held by the Company's Chief Legal Officer).

The Code of Conduct also requires compliance with all applicable laws, rules and regulations including, but not limited to, those guiding our interactions with government officials and health care providers. In this context, the Code of Conduct expressly prohibits any bribes, kickbacks or other improper payments, transfers or receipts.

Our employees are obligated to raise concerns about any violations of our Code of Conduct or any other ethics or conduct violations with their supervisor, the Company's Chief Legal Officer or Chief Compliance Officer, the Audit and Risk Committee of the Board and/or the Nominating and Corporate Governance Committee of the Board or through the Company's Corporate Governance hotline set forth in the Company's Procedures for Reporting Financial and Compliance Matters; No Retaliation Policy (Whistleblower Policy). A current copy of the Whistleblower Policy is available on the Corporate Governance page of the Investors section of our website.

Responsible Research

Clinical Trials

As a patient-focused organization, we value the patients who choose to participate in clinical trials and maintain policies, procedures and practices that are respectful of each study participant and designed to protect their health, safety and well-being. We ensure that our clinical programs comply with the laws and regulations of the jurisdictions where we conduct clinical research, including appropriate informed consent processes, ongoing assessment of patient safety and timely reporting of adverse events, accurate collection and integrity of data and respect for patient confidentiality and privacy.

Ethical Treatment of Animals

Alkermes is committed to the ethical and responsible treatment of animals involved in the Company's research and development programs. We follow defined practices and standards for the care, welfare and treatment of research animals, as monitored by our Institutional Animal Care and Use Committee; and conduct all animal research in compliance with applicable local, national or international laws such as those set forth in the National Research Council's Guide for the Care and Use of Laboratory Animals. We also require - through inclusion of relevant provisions in our contractual agreements - that the CROs, academic institutions and animal vendors with whom we engage commit to adherence to these same standards.

Responsible Manufacturing: Product Quality and Safety

Alkermes has robust policies and procedures in place to promote safe and sustainable research, development, manufacture and commercialization of products. We are committed to meeting our manufacturing objectives reliably and responsibly through the establishment and maintenance of a safe, sustainable and ethical supply chain.

Product Quality

The Alkermes Quality Management System (QMS) is a comprehensive program designed to ensure that products manufactured, stored, tested or distributed by Alkermes consistently meet applicable product specifications, safety and efficacy standards, GxP (as defined below) "good practice" quality guidelines and regulations, and regulatory requirements. The QMS is a combination of multiple wellintegrated components, covering the entire lifecycle of the products that we manufacture from development to commercialization and the full supply chain associated with each stage in a product's manufacture.

Our QMS is designed to ensure compliance with applicable provisions of the U.S. Code of Federal Regulations, ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) Guidance, the European Commission Directives relating to medicinal products for human use and all aspects of "good practice" quality guidelines and regulations (known collectively as GxP), in each case in line with current industry standards.

GxP includes Good Clinical Practice (GCP) regulations, which govern the conduct of clinical trials, Good Manufacturing Practice (GMP) regulations, which govern the manufacture of products, and Good Laboratory Practice (GLP) regulations, which govern the testing of materials in accordance with applicable regulations. We also adhere to applicable quality and safety regulations under the U.S. Controlled Substances Act.

We implement rigorous internal processes to ensure the quality and safety of our products across their lifecycle - from preclinical studies to commercial use. We purchase our raw materials from suppliers assessed and approved by our Quality team. We carry out in-house testing of raw materials prior to use to confirm they meet our quality standards, and we audit and assess our external manufacturing partners to monitor their compliance with Alkermes standards of quality and with applicable laws and regulations as set forth in more detail below. We also carry out in-house testing of all drug product that we manufacture prior to its release to ensure it meets our quality and compliance requirements.

In addition, the FDA, the European Medicines Agency (EMA) and other global regulatory agencies routinely inspect our facilities in Athlone, Waltham and Wilmington to confirm and certify our compliance with applicable regulatory requirements. To date, all such regulatory inspections have been completed successfully, with no "significant findings." FDA inspections of Alkermes sites in the past 5 years have all been classified as "No Action Indicated."

The Alkermes Quality Manual lays out the various principles of quality that are required to be upheld by Alkermes employees and provides guidance for adherence to applicable quality requirements. As part of our QMS, Alkermes employees also receive comprehensive training on the safety and quality resources and standard procedures that we have in place to help ensure our high standards of quality and safety are part of day-to-day operations. Employees are required to train on all new or updated procedures required for their role. Electronic learning systems are used to monitor and manage each employee's compliance with our training curriculum. Training curricula are developed to specifically match each employee's role. Depending on the complexity of an employee's role and the required training for such role, classroom and/or supervised on-the-job training is also provided as needed. We maintain and continually assess, modify and improve our QMS through management's oversight of the system and through our established quality procedures, including internal audits, external audits, risk assessments, quality performance metrics, corrective actions and preventive actions.

Responsibility in the Supply Chain

Beyond our own facilities, we contract with a growing network of third-party manufacturers to formulate certain products and produce components of products or product packaging for clinical and commercial use. All service providers involved in the manufacture and packaging of our products, or components of our products, are subject to inspection by the FDA or comparable agencies in other jurisdictions, and we require that our contract manufacturers adhere to current GMP in the manufacture of these products and product components. Alkermes Quality personnel audit all of our contract manufacturers and suppliers to assess their compliance with applicable standards and regulations prior to initiating work for Alkermes. We have quality agreements in place with our key suppliers that set forth our quality requirements and procedures and govern monitoring of and compliance with such requirements and applicable laws and regulations. We routinely review, assess and update our requirements, as appropriate, based on new or emerging risks identified, and revise our quality agreements accordingly. Strategic supply chain partners are also informed of and expected to comply with Alkermes EHSS standards and expectations.

If a vendor does not meet our EHSS or quality expectations, we either work with that vendor to improve its adherence prior to working with such vendor or consider alternative vendors.

Responsible Marketing

Sales and Marketing Practices

Alkermes' Healthcare Compliance Program, which reflects the Department of Health and Human Services' Office of Inspector General's seven elements of an effective compliance program, encompasses a series of coordinated, proactive efforts to create, propagate and enforce a culture of compliance designed to ensure that our interactions with those who use our products are consistent with applicable laws, regulations and guidelines.

This program is based on the following principles:

Interactions with customers are focused on education as to the benefits and risks of our products in order to help advance their appropriate use. Interactions with customers must occur in a venue conducive to education and Alkermes prohibits the provision of entertainment to its customers.
Promotional communications must be truthful, not misleading, fairly balanced with appropriate safety information, and consistent with the product's label.
Employees are prohibited from using items of value or inkind services to reward or induce a healthcare professional to utilize, prescribe, purchase or recommend our products.
The hiring of healthcare professionals as speakers or consultants must be based on a legitimate business need and free from inappropriate influences, and any fees paid to healthcare professionals may not exceed fair market value of the service being provided.

Patient Safety

We are committed to ensuring the authenticity of our medicines and guarding against counterfeit products (those not equivalent in quality, safety and efficacy, or not containing the correct amount of active ingredient and/or containing impurities) in the marketplace in order to protect patients who use our medicines. Alkermes has established a standard operating procedure (SOP) in accordance with FDA regulations that provides for the timely and efficient removal from the market of any commercial drug product suspected or found to be defective. This SOP covers all products - including trade products, sample products and clinical supplies of product candidates - manufactured and distributed by or on behalf of Alkermes. It also includes requirements for the notification of and consultation with applicable regulatory authorities, the conduct of a health hazard assessment, and communications to customers, partners, healthcare professionals and patients as directed by regulators or our internal policies or procedures.