Emergent BioSolutions Inc. (“Emergent”) has appointed a Corporate Compliance Officer (“CCO”), who is charged with overseeing the Emergent Compliance Plan (“Compliance Plan”). The CCO is responsible for developing the standards of conduct issued as part of the Compliance Plan, oversight of auditing and monitoring activities, as appropriate, and implementing corrective measures, as necessary.
Compliance Plan (CP)
The goal of the Compliance Plan is to prevent, detect, and correct practices or incidents that do not comply with the law or with Emergent’s policies. The United States Office of Inspector General’s (“OIG”) voluntary Guidance for Pharmaceutical Manufacturers (“the OIG Guidance”) has been reviewed and Emergent’s policies are consistent with the Pharmaceutical Research and Manufacturers Code on Interactions with Healthcare Professionals “PhRMA Code”). These guidelines serve as the basis of the Compliance Plan.
Code of Conduct
Emergent has also created a Code of Conduct and Business Ethics. The Code of Conduct applies to all Emergent employees, including officers and directors. All of Emergent’s personnel are expected to comply with the Code of Conduct, and all compliance policies as applicable to their activities.
Emergent is committed to developing and providing effective compliance training for all of its employees, not only on the elements of the Compliance Plan, but also on the pertinent federal and state standards. Emergent will periodically conduct internal auditing and monitoring to evaluate compliance with company policies and identify additional areas in which to implement additional training and policies.
Emergent has established internal lines of communications and open-door and non-retaliation policies that encourage all employees to promptly report any concerns that they may have regarding violations of the Code of Conduct or the Compliance Plan. Concerns may be reported anonymously through the Company’s anonymous reporting system by phone or directly to the CCO, any manager, the HR Department, a member of the Leadership Team, or the General Counsel.
Emergent and the CCO, or delegate, will evaluate and investigate all reports, as appropriate. When appropriate, corrective disciplinary action will be imposed, without regard to the employee’s level within the organization.
Emergent is committed to promptly revising and amending the Compliance Plan at any time should issues or violations arise due to gaps in policy, practice, or internal controls.
SB 1765 Declaration
California law SB 1765, codified at California Business and Professions Code, Sections 119400 to 119402 (“the California law”), requires all pharmaceutical and medical device companies to adopt a compliance plan based upon the OIG Guidance and the PhRMA Code. Under the California law, a pharmaceutical company must also annually declare that it is in compliance with its own compliance plan and the requirements of the Sections 119400 to 119402. A pharmaceutical company must make its compliance plan and its annual declaration of compliance available to the public on its website and through a toll-free number. We understand the California statute only imposes these obligations for activities directed to citizens of California.
Emergent declares that to the best of our knowledge, and based on a good faith understanding of the California statute, as of August 2016, Emergent is in compliance with the Compliance Plan described above. The Compliance Plan is intended to be a dynamic program to meet the company’s evolving compliance needs and expectations. Therefore, Emergent will continue to develop and refine its Compliance Plan.
Annual Spending Limit
The California law requires pharmaceutical companies to adopt a specific annual dollar limit on gifts, promotional materials, or items or activities that the pharmaceutical company and its employees and representatives may give or otherwise provide to an individual medical or health care professional in California. The limit does not include amounts attributable to drug samples, financial support for continuing medical education, or payment for legitimate professional services.
Emergent has adopted an annual spending limit of $ 2,500.00. This limit is neither an average spending limit, nor a targeted spending limit, and Emergent believes that its actual spending will be less than this limit. Emergent reserves the right to revise its annual limit from time to time.
Dated: August, 2017