California Comprehensive Compliance and Ethics Plan Information MISSION STATEMENT Colgate Oral Pharmaceuticals (“COP”) is committed to conducting its business consistently with all applicable laws and regulations and the highest standards of business integrity. Thus, COP has established this Comprehensive Compliance and Ethics Plan (“CCEP”) to ensure our organization’s adherence with all applicable laws, regulations, and guidance, including those that govern the sale and marketing of pharmaceutical products. The CCEP, together with COP’s other internal policies and procedures, is designed in accordance with the “Compliance Program Guidance for Pharmaceutical Manufacturers” from the U.S. Department of Health and Human Services, Office of Inspector General. The CCEP and related COP policies and procedures also have been designed to be consistent with the Pharmaceutical Research and Manufacturers of America’s (“PhRMA”) “Code on Interactions with Healthcare Professionals” (“PhRMA Code”). All personnel must conduct their responsibilities in full compliance with applicable law, regulations, policies, and procedures. The CCEP sets forth the manner-in which COP and its employees shall conduct business, including establishing: • • • • An annual certification process for those that interact with healthcare professionals; Compliance training to ensure personnel are aware of and understand applicable law and regulations and the CCEP; A process for reporting and investigating concerns or potential violations, including corrective and disciplinary measures to address violations; and An auditing and monitoring process to ensure compliance. All COP personnel who interact or communicate with U.S. dentists, other healthcare professionals and providers, patients, government personnel, and the media must read, fully understand, and comply with this CCEP. Each employee will be required on an annual basis to certify that the employee has read, understands, and will abide by the CCEP. Copies of the CCEP and our written declaration of compliance with California Health & Safety Code § 119402 may be obtained by calling 1-800-2-COLGATE. COMPANY POLICIES AND PROCEDURES AND COMPLIANCE WITH RELEVANT LAWS AND GUIDANCE COP is committed to refraining from activities that violate or appear to violate any laws that apply to it. It is the responsibility of all COP personnel to avoid any violation of these laws. COP has developed and implemented written compliance policies and procedures designed to ensure consistency with applicable law and regulations. The COP Pharmaceutical Code Compliance Officer and other designated personnel are charged with developing, implementing, communicating, and updating the Company’s compliance policies and procedures. To support its objectives under the CCEP, COP also follows the Colgate-Palmolive Code of Conduct, which summarizes additional compliance and ethics standards that govern all COP operations. Please see the link to the Code of Conduct here: http://www.colgate.com/Colgate/US/Corp/LivingOurValues/CodeOfConduct/PDFs/DY245%20code_of_conduct_p_ENG_no%20faq.pdf. COP will provide the CCEP, ColgatePalmolive Code of Conduct, and other relevant policies and procedures to all Company personnel affected by their contents. In addition to federal requirements, several states have also implemented laws and regulations that regulate interactions with healthcare professionals. COP is committed to ensuring that its personnel conduct their responsibilities in full compliance with any applicable state law, regulation, or policy. PhRMA Code, along with the Colgate-Palmolive Code of Conduct, provides guidance to avoid violations of these laws. Each COP employee who has contact with healthcare professionals should be familiar with and comply with these guidelines. Each employee will receive a copy of the PhRMA Code and Colgate-Palmolive Code of Conduct. The following summarizes the way we conduct our interactions with healthcare professionals under the PhRMA Code: Unless prohited under state law, COP may occasionally offer a modest business meal, consistent with the PhRMA Code, as part of an educational presentation or business discussion in an office or clinical setting. COP trains personnel conducting promotional activities in certain states to adhere to stricter requirements. If you have questions about whether a state in which you carry out your responsibilities has stricter requirements, please contact the Compliance Officer. COP does not provide entertainment (sporting events, concert tickets, etc.) to customers. Unless prohibited under state law, COP may provide items of educational value to healthcare professionals if the items are not of substantial value ($100 or less) and do not have value outside of his or her professional responsibilities. COP trains personnel conducting promotional activities in certain states to adhere to stricter requirements. If you have questions about whether a state in which you carry out your responsibilities has stricter requirements, please contact the Compliance Officer. COP will, with very limited exceptions, in accordance with applicable standards, not reimburse travel and lodging expenses of attendees at promotional and educational programs. In accordance with applicable law and regulations and COP’s policies and procedures applicable to educational grants, COP may provide grants for specific educational purposes. These may include, but are not limited to, continuing education programs and fellowships provided to organizations that provide high-quality, nationally recognized patient education. In accordance with applicable law and regulations and COP’s policies and procedures applicable to charitable contributions, COP will consider charitable contributions and requests for patient assistance in the areas of children’s health, health care education, 2 access to health care and community responsibility consistent with Colgate-Palmolive Values and Policies. PHARMACEUTICAL CODE COMPLIANCE OFFICER COP’s Pharmaceutical Code Compliance Officer, Kate Parrish, is a member of the COP management team who oversees all compliance activities related to state compliance programs, including CCEP, regarding the sale and marketing of pharmaceutical products. The Pharmaceutical Code Compliance Officer is responsible for developing and implementing policies, procedures and practices designed to ensure that all COP personnel comply with federal healthcare programs. In addition, the Pharmaceutical Code Compliance Officer will provide periodic reporting regarding relevant activities to the COP Leadership team. COMPLIANCE AND ETHICS TRAINING PROGRAMS COP is committed to providing effective education and training to all COP personnel that will ensure compliance with applicable laws governing the sale and marketing of pharmaceutical products as well as relevant COP policies, practices and procedures. All COP compliance training programs will be consistent with internal Colgate-Palmolive Company (“Company”) training standards and will be carried out under the general direction of the Pharmaceutical Code Compliance Officer in conjunction with the Company’s Global Education and Training. COP’s pharmaceutical compliance training programs are implemented in a manner to promote 1) awareness and understanding of the aforementioned applicable laws, internal policies, practices and procedures and 2) compliant and ethical behaviors within the COP organization. REPORTING AND INVESTIGATING COMPLIANCE ISSUES Reporting Suspected Violations Since its introduction in 1995, the Company’s Code of Conduct Hotline has helped to ensure that the Company’s business is conducted in accordance with the highest ethical standards. Based on our established internal practices, if a COP employee has good reason to suspect a violation of the Company’s Code of Conduct or any other Company guidelines, they are required to immediately report that information to their manager, Human Resources or Legal without fear of reprisal. COP employees may also contact the Company’s Global Ethics and Compliance department through the 24-hour Code of Conduct Hotline at 1-800-778-6080 (North America) or 212-310-2330 (collect from locations outside North America). In addition, complaints may be submitted via email to ethics@colpal.com. The Company will not retaliate against any individual who reports information concerning potential violations in good faith or who participate in any investigation unless the information provided is found to be intentionally false. The Company will also take all necessary steps to keep an individual’s identity and the information he or she submits confidential and will only disclose information on a need-to-know bases where that disclosure is: 3 Unavoidable in order to conduct an effective investigation and take appropriate action or Otherwise required by applicable law If the violation is related to the pharmaceutical code or a state compliance program, the Company’s Global Ethics & Compliance department will refer the matter to the COP Pharmaceutical Code Compliance Officer for dispensation. Investigating Complaints All reported violations will be promptly investigated. It is imperative that the reporting person(s) not conduct their own investigation. Acting on your own may compromise the integrity of an investigation and adversely affect both the Company and the employee. Taking Disciplinary Action COP intends to proactively prevent the occurrence of conduct that is not in compliance with its state compliance programs regarding the sale and marketing of pharmaceutical products. COP believes that it is important to take reasonable and consistent corrective action to address noncompliance issues and deter potential future misconduct. Corrective action may include a broad range of disciplinary measures, including remedial compliance training, an oral or written warning or other appropriate actions up to and including termination. Furthermore, substantiated non-compliance with COP pharmaceutical code policies and procedures will be a factor in applicable employee performance reviews. AUDITING AND MONITORING COP regularly audits and monitors its compliance policies and procedures to ensure the effectiveness of this CCEP and other COP compliance guidelines. Auditing and monitoring activities are designed to identify matters that require further investigation and opportunities for additional compliance training. Auditing and monitoring results may be used to make changes in business practices or COP policies or procedures. COP considers a number of factors in connection with the nature, frequency, and extent of such reviews, including changes in applicable law and regulation or areas of particular concern or interest. CALIFORNIA SPENDING LIMIT As required under Section 119402 of the California Health and Safety Code, COP has established an annual company spending limit on promotional items or activities provided to medical or health professionals licensed in California. COP's annual spending limit is $2,000 per professional for activities occurring between October 1, 2010 - September 30, 2011. This limit does not cover payments that are excepted from Section 119401 of the California Health and Safety Code (i.e., drug samples given to healthcare professionals intended for free distribution to patients, financial support for continuing medical education forums, financial support for health educational scholarships, and payments made for legitimate professional services where the 4 payment does not exceed fair market value and otherwise complies with COP’s policies and procedures, the OIG Compliance Guidance for Pharmaceutical Manufacturers, and the PhRMA Code). REVISIONS As part of its commitment to compliance and to ensure the effectiveness of its policies and procedures, COP requires the Compliance Officer to review on an annual basis the CCEP and other internal compliance policies and procedures to determine whether any of the organization’s materials should be revised, supplemented, or otherwise updated. The guidelines set forth in this document may be modified as needed, as determined and approved by COP Pharmaceutical Code Compliance Officer, Kate Parrish and Vice President and General Manager Sheila Hopkins. 5