Internal Compliance Program Clause Samples

Internal Compliance Program. Distributor has and shall maintain an internal compliance program, including at a minimum the following elements: a. Assignment of overall responsibility for compliance to an appropriate officer of Distributor, whose responsibilities will include: coordinating Distributor's internal auditing and monitoring program; ensuring effective compliance training for Distributor and its Representatives on compliance issues and compliance with Applicable Laws, including Healthcare Laws and AATB Guidance; creating, communicating, and maintaining effective mechanisms for Distributor Representatives to report compliance-related issues and concerns; maintaining and updating Distributor's policies and procedures to reflect new risks or changes in law or Company policies and procedures applicable to Distributor's performance under this Agreement to reflect new risks or changes in law or regulation; corresponding and coordinating with Company as needed on compliance issues or questions that arise; and performing regular auditing and monitoring of Distributor's compliance with Healthcare Laws and the requirements of this Agreement; b. Establishment of effective lines of communication for reporting compliance questions and concerns, including at a minimum a mechanism for directly reporting compliance concerns to Distributor's officer responsible for compliance and a mechanism for reporting anonymously, such as an anonymous website or telephone line; communicating the availability of these reporting mechanisms to Distributor Representatives; providing regular reminders of the duty to report actual or potential misconduct; implementing and enforcing a policy of strict non-retaliation against any person for reporting in good faith a potential compliance concern; and communicating this policy of non-retaliation; c. Regular auditing and monitoring of Distributor's compliance, including the development and annual update of an internal auditing and monitoring plan, which shall describe in reasonable detail the scope and subject of Distributor's internal auditing and monitoring efforts to address potential compliance risk areas;

Internal Compliance Program. Charter shall mean the policy-level document outlining the Internal Compliance Program, which has been adopted by the Commission, as that program may be amended from time-to-time.

Internal Compliance Program. Sales Agent shall maintain an internal compliance program, including at a minimum the following elements: a. Assignment of overall responsibility for compliance to an appropriate officer of Sales Agent, whose responsibilities will include coordinating Sales Agent’s compliance obligations under this Agreement; and corresponding and coordinating with Company as needed on compliance issues or questions that arise; b. In support of Sales Agent’s compliance reporting obligations under this Agreement, establishment of effective lines of communication for reporting compliance questions and concerns, the regular publicizing of these lines of communication, and effective procedures for discipline, investigation and resolution; c. Regular monitoring of Sales Agent’s compliance; and d. Compliance training for Sales Agent employees and agents who provide services related to this Agreement, which shall include training on compliance with Healthcare Laws and communication or distribution of applicable Company policies, within thirty (30) days of hire and annually thereafter.

Internal Compliance Program. The Company has established and administers an internal compliance program to assist the Company and the directors, officers and employees of the Company in complying with all applicable Health Care Laws and applicable regulatory guidelines (including, without limitation, those administered by the FDA, the EMA, the MHRA, the BfArM, and any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA or EMA), except where such noncompliance would not reasonably be expected to have a Material Adverse Change, and such compliance program has been designed and implemented in a manner consistent with biopharmaceutical industry standards and best practices, including but not limited to the program elements set forth in the Compliance Program Guidance for Pharmaceutical Manufacturers issued by the Office of Inspector General on May 5, 2003 (68 Fed. Reg. 23,731).