Glenmark Pharmaceuticals Inc., USA Corporate Compliance Program
Statement Of Compliance And U.S. Comprehensive Compliance Program Overview
Glenmark Pharmaceuticals Inc., USA (“Glenmark”) is committed to conducting all Glenmark’s business with integrity and in compliance with laws, rules, regulations, guidelines, and industry standards applicable to our industry and has developed and implemented a comprehensive compliance program (“Compliance Program”) to help meet this commitment. This Statement of Compliance and Compliance Program Overview (“Statement”) reflects Glenmark’s principles and provides an overview of the framework of the Compliance Program.
The effectiveness of the Compliance Program begins with the support and commitment of Glenmark’s leadership. Glenmark’s Board of Directors, the Chief Executive Officer, General Counsel, Compliance Officer and other members of Glenmark’s senior leadership team are committed to promoting a culture of integrity and governing and growing Glenmark through ethical and compliant business strategies.
As described in this Statement, the Compliance Program is a set of internal standards and controls intended to promote the prevention, detection, and correction of conduct that is illegal or that does not conform to Glenmark’s standards of conduct. The Compliance Program is intended to be an integral and routine part of Glenmark’s operations and to apply to all officers, directors, and employees of Glenmark, as well as to anyone conducting business on its behalf (“covered persons”). All covered persons are required to comply with this Statement and all of Glenmark’s policies by respecting the principles and observing the conduct described therein.
The Compliance Program consists of seven key elements, described below.
Glenmark’s Compliance Officer is responsible for support and overseeing its Compliance Program. The Compliance Officer reports directly to the CEO and keeps the Board of Directors apprised of the state of Glenmark’s compliance efforts and any material compliance issues. Glenmark has also established a compliance committee, lead by the Compliance Officer and which is comprised of cross-functional representatives, director-level and above, to meet at least quarterly to review and develop action plans to address compliance-related matters.
Policies And Procedures
Glenmark has developed and distributed written standards of conduct, policies, procedures, and guiding principles which are integral to the Compliance Program. Glenmark’s U.S. Code of Business Conduct Handbook provides an overview of Glenmark’s core values as well as the policies and standards for conducting business in a compliant and ethical manner.
In developing and implementing the U.S. Code of Business Conduct Handbook and other policies related to Glenmark’s operations, Glenmark is guided by the principles set forth in the U.S. Department of Health and Human Services Office of Inspector General (OIG) Compliance Program Guidance for Pharmaceutical Manufacturers dated May 5, 2003 (the “OIG Compliance Guidance”), as well as other relevant industry guidance.
Glenmark’s policies and procedures do not address every situation that may arise. In addition, Glenmark’s policies and procedures supplement, and do not replace, federal, state and local laws, rules, regulations, guidelines and industry standards. The absence of a specific guideline does not relieve Glenmark of responsibility for operating ethically. Questions regarding Glenmark’s policies and procedures should be directed to the Compliance Officer.
Education And Training
This Statement, Glenmark’s U.S. Code of Business Conduct Handbook, and any applicable Glenmark policies and procedures are provided to each covered person upon beginning work with Glenmark and are available at any time from the Compliance Officer. In
addition, Glenmark requires annual and periodic training and education of employees on the Compliance Program and its application, as well as laws, rules, regulations, guidelines and industry standards that govern pharmaceutical marketing and selling activities in the U.S. The Compliance Officer shall arrange, where appropriate, for Glenmark to offer more targeted training and education of covered persons on laws, regulations and compliance matters relevant to their work for Glenmark.
All Glenmark covered persons must be attentive to possible violations of Glenmark’s U.S.Code of Business Conduct Handbook, applicable laws, rules, regulations, guidelines, industry standards and Glenmark policies, and communicate possible violations. Glenmark is committed to promoting open dialogue and has established multiple lines of communication to report such violations without fear of retaliation.
Glenmark encourages covered persons to discuss all issues, concerns, problems, and suggestions with their immediate supervisors or other managers without fear of retaliation and with the assurance that the matter will be kept as confidential as possible. In addition, covered persons may submit reports of violations or potential violations in writing confidentially to the human resources, legal, compliance or finance departments. Finally, Glenmark has established an anonymous ethics hotline to report violations or potential violations, which is operated by a third party and is available 24 hours a day, 7 days a week. Reports may be submitted by telephone to (855) 409-0973 or online at http://glenmarkpharma.ethicspoint.com/. Some local limitations apply to reports submitted from outside the United States to comply with local laws.
Investigating Misconduct; Enforcement And Discipline
Glenmark is committed to fully investigating and responding to all reported compliance concerns and prohibits retaliation against any person who, in good faith, reports known or suspected compliance issues. Glenmark maintains policies and procedures for addressing potential compliance-related violations, which help ensure that relevant facts and circumstances are understood and considered in connection with all enforcement and disciplinary activities. These policies and procedures are intended to help ensure that appropriate and consistent action is employed to address inappropriate conduct and deter future violations.
Where an internal investigation substantiates a reported violation, Glenmark will initiate timely and appropriate corrective action. While each situation is unique, such action may include, as appropriate and without limitation, imposing disciplinary action, terminating contracts or employment, or implementing training or systemic changes to prevent similar violations from recurring.
It is important to note that Glenmark may consider whether a violation may be due in part to gaps in its policies, training, business practices, or other controls. If so, Glenmark is committed to putting corrective measures in place to enhance its controls to prevent further violations.
Monitoring And Auditing Of Compliance
Glenmark is committed to making compliance with ethical and legal standards an integral part of its daily operations. As such, Glenmark conducts auditing and monitoring activities designed to assess compliance with its ethics and compliance policies, procedures and processes. Effective monitoring and auditing may allow Glenmark to identify potential training and policy/process needs, and to detect and prevent deviations from its policy, procedure or process that, in certain circumstances, can potentially increase compliance concerns. Monitoring may also help to determine whether the Compliance Officer has adequate time and resources to effectively monitor compliance or whether additional resources, including for example a compliance audit performed by a third party, may be necessary. The frequency and nature of the monitoring activities depend on numerous factors, including laws, rules, regulations, guidelines, industry standards and changes in business strategy.