Anti-Corruption and Healthcare Compliance Policy. Approved By: Corporate Compliance Effective Date: October 15, 2015

Transcription

1 Anti-Corruption and Healthcare Compliance Policy Approved By: Corporate Compliance Effective Date: October 15, 2015 Table of Contents 1. Purpose Scope Definitions Anti-Corruption Standards General Principles Payments and Transfers of Value Accurate Books and Records Use of Third-Party Representatives Cross Border Interactions with GOs and GEs Bidding and Tendering Standards for Commercial Interactions Reporting and Non-Retaliation Healthcare Compliance Standards General Standards for Interactions with Customers Promotional Interactions with Customers Meals and Entertainment Visits to Company Facilities and Other Travel Gifts to Customers Fee For Service Arrangements Funding of Third Party Meetings Sponsorships of Customers to Attend Third Party Meetings Charitable Contributions No-Charge Products Product-Related Research Attachment 1 Policy Limits and Thresholds... 22

2 1. Purpose: 1.1 Bio-Rad Laboratories, Inc., including its subsidiaries and affiliates ( Bio-Rad or the Company ) is committed to maintaining high standards of integrity in business conduct and promoting compliance with applicable laws and regulations in the countries and regions in which Bio-Rad operates. The United States of America and nearly all other countries have adopted laws prohibiting the bribery of government officials and, in many cases, private or commercial forms of bribery are similarly prohibited (collectively, Anti-Corruption Laws. ). 1.2 This Policy provides the general principles guiding Bio-Rad s interactions with Customers consisting of members of the healthcare community, including but not limited to healthcare professionals ( HCPs ) and healthcare organizations ( HCOs ) and other individuals or entities to whom Bio-Rad promotes or sells or could promote or sell products, including but not limited to wholesalers, distributors, pharmacies, and PhDs. For the purposes of this Policy, the term Customers does not include patients or end consumers. In addition, this Policies applies to Government Officials ( GOs ), Government Entities ( GEs ), and other individuals and entities Bio-Rad interacts with as part of its business. 2. Scope: 2.1 This Policy applies to Bio-Rad employees, including directors, officers, and board members (collectively, and without regard to legal status, Workforce Members ). 2.2 In addition, where necessary and appropriate, distributors, agents, resellers, and other sales and marketing intermediaries ( Channel Partners ) and third-parties such as law firms, accounting firms, regulatory consultants, health and safety advisors, and environmental advisors to provide guidance on sensitive matters, as well as other third-parties who supply services on behalf of Bio- Rad such as customs brokers, logistics providers, travel agencies and meeting planners ( Consultants ) must follow the guidelines provided in this Policy. 2.3 This Policy sets forth Bio-Rad s minimum compliance standards and is supplemented by additional global, regional and country specific policies and Bio-Rad Standard Operating Procedures ( SOPs ) and other guidelines. If local laws, codes of conduct, or other regulations in a particular country or region are more restrictive than this Policy, or require government approval to execute a particular interaction or transaction, then Bio-Rad Workforce Members operating in that country or region must fully comply with these more restrictive requirements. 2.4 Bio-Rad Workforce Members and Channel Partners and Consultants are responsible for determining and recognizing when they are interacting with GOs and GEs and must be familiar with the corruption risks associated with specific business dealings. The definitions and guidance provided in this Policy, other applicable Policies, and local resources may be used in that determination. Any questions pertaining to interactions with GOs or GEs, including any doubts as to whether a person or particular party is a GO or GE, should be directed to Corporate Compliance. 2.5 This Policy was created by Corporate Compliance. Any changes or exceptions to this Policy require consultation with Corporate Compliance. All Bio-Rad Workforce Members and Channel Partners and Consultants are responsible for understanding the requirements of this Policy and for obtaining assistance and guidance from Bio-Rad management, Corporate Compliance, or the Corporate Legal Department whenever a question may arise. Improper conduct is not consistent with Bio-Rad s commitment to a culture of doing business in an ethical manner and any violation of this Policy will be grounds for discipline, up to and including termination. Violations of the Anti- Corruption Laws can lead to costly enforcement actions against the Company and individuals involved, reputational damage to the Company and its Workforce Members, criminal and 2

3 administrative penalties, including debarment, against both the Company and the individuals involved. Persons found guilty of bribery face possible imprisonment as well as fines. 2.6 All records related to this Policy must be maintained by Corporate Compliance in an established location selected to ensure confidentiality. All records must be maintained for at least seven years, unless a longer period of time is required by local law. Records related to this Policy includes all written documentation that addresses the interpretation, execution, applicability, and all other uses of this Policy. 2.7 This Policy and all related policies will be reviewed, and updated as appropriate, on an annual basis. 3. Definitions: 3.1 Anything of Value should be interpreted broadly and may include, but is not limited to: Cash or cash equivalents, such as gift certificates and gift cards; Gifts, gratuities or no-charge goods, including Bio-Rad products and products purchased from suppliers; Travel, hospitality and meals; Charitable or political contributions (legitimate or otherwise) specified or suggested by a GO; Job opportunities or offers of employment (for which the person would not otherwise qualify) to family members of a GO for the purpose of currying favor; Provision of no-charge services; Intangible benefits, such as enhanced reputational, social or business standing; or Funding arrangements and fee for service arrangements. 3.2 Channel Partners are third parties such as distributors, agents, resellers, and other sales and marketing intermediaries of Bio-Rad products. 3.3 Consultants include entities that provide guidance on sensitive matters, such as law firms, accounting firms, regulatory consultants, health and safety advisors, and environmental advisors. Consultants also include entities that supply services on behalf of Bio-Rad such as customs brokers, logistics providers, travel agencies and meeting planners. 3.4 The term GE or government entity is defined broadly to include national, state or local governments or government departments, bodies, agencies or other government entities, as well as public international organizations, government-owned enterprises, and political parties. Public international organizations include any organization with two or more governments as members. Government-owned enterprises are any entity, whether organized under public or private law, in which one or more governmental entities has a sufficient ownership or political interest to give it control. A majority of the voting shares would clearly qualify, as would one golden share or other mechanism, if it conferred control. The definition of GE could include health clinics, academic medical centers and research departments of publicly funded universities. 3.5 The term GO or government official includes anyone elected or appointed to, or otherwise working at a GE or government entity, as well as any candidate for political office or political party. A GO could include the following: Any officer or employee of a government or any department, agency, or instrumentality of a government; Any person acting in an official capacity for or on behalf of a government or any department, agency, or instrumentality of a government; Any officer or employee of a company or business owned or controlled in whole or part by a government; 3

4 Any officer or employee of a public international organization such as the World Bank or the United Nations; Any officer or employee of a political party or any person acting in an official capacity on behalf of a political party; and/or Any candidate for political office. Based on these definitions, examples of GOs could include employees of a state-owned hospital, utility or other enterprises, local police officers, military employees, university representatives, customs officials, officers of the World Health Organization, Council of Europe, World Bank or United Nations, mayoral candidates, members of Parliament or judges, prosecutors or court clerks. 3.6 The term Government Officials who are Customers refer to Customers, especially HCPs, employed by or acting on behalf of a government-owned or operated healthcare facility, institution, university or hospital. This Policy provides guidance on interactions specific to the medical-device industry (e.g., sales, marketing, and research related activities) which often involve GOs who are also Customers. Bio-Rad Employees may interact with GOs who are also Customers in the following ways: (i) in the course of the GO s official capacity; (ii) as a consultant through a Fee for Service Arrangement; (iii) through Sponsorships, Conferences and Congresses; or (iv) through other activities as part of Bio-Rad s business activities. For Customers that are GOs and GEs, section II of this Policy provides additional requirements that supplement the requirements below for Interactions with Customers. In situations where both apply, the more restrictive standard must be used. 3.7 Health Care Professional or Health Care Organization includes individuals or entities (i) which are involved in the provision of health care services and/or items to patients; or (ii) which purchase, lease, recommend, use, arrange for the purchase or lease of, or prescribe medical products. 3.8 An improper advantage is any advantage gained by the Company not on the merits of its business but because a GO, or any individual in such capacity, violated the public trust for the Company s benefit. Such an improper advantage could include a new business award, a tax reduction, a regulatory approval or any other official action that is unwarranted, including expediting the receipt of a permit or license. Improper advantage is not limited to gains associated with actions of GOs. An improper advantage can also be when a commercial representative violates his/her company policy and/or breaches his or her duty of loyalty to that company for Bio-Rad s benefit. Such an improper advantage could include a new business award, a contract renewal, or any other commercial action that is unwarranted or not in the best interest of their company. 3.9 The term, influence official action means to attempt to induce a GO to act or refrain from acting in any way Workforce Members include Bio-Rad directors, officers, employees, temporary workers and leased workers. 4. Anti-Corruption Standards: 4.1 General Principles It is the policy of the Company to prohibit bribery or corruption of any kind in any location. Accordingly, no Workforce Member or Channel Partner or Consultant may directly or indirectly through another party, offer, promise, give, demand, accept, or authorize the giving of anything of value or undue advantage to any individual or entity in order to influence official action, obtain, retain or direct business or to secure any other improper advantage in the conduct of business. 4

5 This includes interactions with any public official, a political candidate, political party or party official, or any private sector employee (including a person who directs or works for a private sector enterprise in any capacity). In addition, Bio-Rad Workforce Members and Channel Partners and Consultants cannot assist individuals or entities with avoiding compliance with their own policies, laws and regulations (e.g., remitting payments to a country different from the country of the counterparty providing the good or service). 4.2 Payments and Transfers of Value Permissible Payments and Transfers of Value: Bio-Rad strictly limits payments and transfers of value, including monetary and non-monetary transfers, of any kind to GOs or GEs. Payments, or Anything of Value, given to or at the request of a GO or GE must meet all of the following criteria: Must be consistent with local laws and regulations; Must be made only for a legitimate business purpose; Must be at the Fair Market Value (FMV) for the goods or services rendered, and consistent with fees published in a publically available government publication, as applicable; Must be transparent and paid only for government actions for which an official receipt can be provided; Must be properly recorded and adequately documented; Must be supported by a Written Agreement approved by the Legal Department if the payment is for a Fee for Service Arrangement contract, where applicable; and Be consistent with the AdvaMed Code of Ethics on Interactions with Health Care Professionals. Heightened sensitivity must be given to situations where Bio-Rad seeks to provide a permissible payment to a GO or GE that is involved in awarding business to or influencing government action with respect to Bio-Rad, so as not to create the perception of a corrupt purpose. In situations where a business decision affecting Bio-Rad is currently pending before a GO or GE, Bio-Rad must avoid making any payments to the GO or GE (monetary or non-monetary, including permissible payments) until the pending business decision has reached final resolution. This includes giving consideration to whether or not a business decision is pending prior to providing a permissible payment to a GO or GE Prohibited Payments and Transfers of Value: The following types of payments and transfers of value, including monetary and non-monetary transfers, to GOs or GEs are expressly prohibited: Payments made with an intent to influence the GO or GE inappropriately; Payments made in exchange for the award of business or other improper advantage; Payments that are extravagant in nature, type or amount; and Facilitation Payments (see below) Facilitation Payments: All Bio-Rad Employees must adhere to the Bio-Rad Global Code of Business Ethics and Conduct, which prohibits Bio-Rad from making Facilitation Payments to GOs or GEs. Facilitation Payments are small payments made to a GO or GE to expedite or secure performance of a routine governmental action that is nondiscretionary, and for which a small payment is necessary to get or expedite the requested action. The term routine governmental action does not include any decision by a GO or GE on whether, or on what terms, to award new business to or to continue to do business with a particular party, or any action taken by a GO or GE involved in the decision-making process to encourage a decision to award new business or to continue business with a particular party. Examples of facilitation payments include payments made to: 5

6 Obtain permits, licenses, or other official documents for qualification to conduct specific business; Process visas and work permits; Provide police protection; Pick up or deliver mail; Schedule inspections related to contract performance or related to transit of goods; Supply phone service, power, or water; Load or unload cargo; and Protect perishable products or commodities from deterioration Transparent Payments in Official Capacity: Bio-Rad Workforce Members regularly will come into contact with GOs acting in their official capacity during the completion of routine government actions such as inspections, audits, applications for permits and licenses, and matters involving compliance with customs, immigration and tax laws. Many of these situations may require Bio-Rad to make legitimate payments (i.e., administrative fees) that are not considered to be facilitation payments. Approval by the Legal Department must be obtained prior to engaging any Channel Partner or Consultant for services relating to customs, importing/exporting, product registrations, or any other services which may involve interactions with GOs Travel, Hospitality and Meals to GOs or GEs: Payments (including monetary and nonmonetary payments) made to GOs or GEs for travel, hospitality and meals are strictly prohibited. Payments associated with Workforce Member travel, hospitality or meals involving interactions with GOs must comply with the following criteria: The underlying expense must be permitted under local laws, regulations and country codes; The activity involving the expense must be directly related to the promotion, demonstration or explanation of Bio-Rad products or services; Payments must be directly related to performance of a contract with a GO or GE, if applicable; and Meal amounts must comply with the limits outlined in Appendix I of this Policy. Bio-Rad may be requested to pay for GOs or Customers to travel to Bio-Rad events, trainings, manufacturing sites. Company Workforce Members may only offer to pay for third-party travel or make offers of payments for services to GOs or Customers in accordance with the Company s Travel and Related Expense Policy. Following the approval and provision of any third-party travel or payment for services, Workforce Members should refer to the Spend Transparency Policy to review Bio-Rad s reporting requirements Gifts, Promotional Items and Samples: Providing the following gifts (excluding educational items which have scientific or educational value and no personal use for the recipient) to GOs is strictly prohibited: Cash and cash equivalents; Gifts to a GO s spouse, family members or friends; Gifts given as a thank you for a specific decision to purchase Bio-Rad products or services; Gifts directly solicited by a GO; Reimbursement of the cost of any gift to a GO made by a Channel Partner, Consultant or other business partner; and Wine and other alcoholic beverages Charitable Contributions for the benefit of or at the request of GOs: Bio-Rad is prohibited from making charitable contributions that could result in payments to, for the benefit of, or at the request of GOs. This prohibition extends to charitable contributions 6

7 that could result in tangible or intangible benefits to a GO s spouse, family members or friends Political Contributions: Many of the countries where Bio-Rad conducts business strictly regulate the activities of corporations in the political process. No corporate funds, facilities or services of any kind may be paid or provided to any political candidate for public office, to any political party or to any political initiative, referendum or other form of political campaign Engagement of GOs for Services: Where permitted by local law, Bio-Rad may engage GOs or GEs for services. Examples of these services may include consultants, researchers, and speakers or presenters. These services must comply with the following criteria: Stem from a legitimate business purpose for the service, with the services provided by someone qualified to meet the purpose; Involve the minimum number of GOs needed to achieve the legitimate business purpose; Involve payment that represents the FMV of the services provided; Include the applicable anti-corruption compliance provisions in the governing agreements, as directed by the Legal Department Must be properly recorded and adequately documented in accordance with this Policy; In situations where Bio-Rad seeks to engage the services of a GO who is involved in awarding business to or influencing government action with respect to Bio-Rad, preapproval from the Legal Department and Corporate Compliance must be obtained; Must not be perceived as inappropriately influencing a GO due to the total level of payments received by the GO; and Be preceded by notice to the employer or supervisor of the persons whose services will be engaged (in certain circumstances, the Legal Department may require written acknowledgment from the relevant GE) Other Transfers of Value to GOs or GEs: There also may be additional interactions involving GOs or GEs, who are also Customers that may involve payments or transfers of value, including monetary and non-monetary transfers. Refer to Section III of this Policy for additional guidance regarding these interactions. 4.3 Accurate Books and Records Bio-Rad must keep books, records, and accounts that accurately and fairly reflect all Bio-Rad transactions. All transactions entered into by Bio-Rad must have proper internal authorization and approval. All expenses, including expenses for gifts, meals and entertainment, must be accurately reported and recorded. All accounting records, expense reports, invoices, vouchers and other business records must be maintained in a complete and accurate manner and must be recorded based on generally accepted accounting practices. False or misleading entries and undisclosed or unrecorded payments or accounts are strictly prohibited, as are any acts intended to avoid the operation of Bio-Rad s internal accounting controls. Workforce Members are required to follow all internal controls established by Bio-Rad to ensure that transactions are properly authorized, documented and executed consistent with management s direction, including following all established delegations of authority and approval processes. Workforce Members are prohibited from taking any actions designed to circumvent these controls, e.g., structuring transactions so as to evade or circumvent financial approval requirements or creating multiple payments for the same transaction in order to avoid applicable approval requirements. 7

8 4.4 Use of Channel Partners and Consultants Bio-Rad Channel Partners and Consultants may include any third party retained to represent Bio- Rad in interacting with GOs or GEs. Actions by these Channel Partners and Consultants may result in liability for Bio-Rad. Whenever Bio-Rad Workforce Members engage a Channel Partner or Consultant, the Bio-Rad Workforce Member has a responsibility to notify the Channel Partner or Consultant of this Policy and to ensure that the Channel Partner or Consultant complies with this Policy. Appropriate due diligence procedures must be performed with respect to the services of potential and current Channel Partners and Consultants. Refer to the Due Diligence SOPs for guidance on conducting due diligence on Third-Party Representatives. 4.5 Cross Border Interactions with GOs and GEs Certain interactions may involve GOs or GEs based in a different country than the location of the Bio-Rad Workforce Member or Channel Partner or Consultant interacting with these parties. These interactions must follow the laws and codes of both the country of the GO or GE (home country) and of the country where the Bio-Rad Workforce Members or Channel Partners and Consultants are performing their business (host country). In the event of any conflict between these laws or codes, the more restrictive requirement (host or home) applies for the interaction. Responsible Workforce Members and Channel Partners and Consultants must contact the Legal Department to understand any additional legal requirements and interpretations or other compliance requirements of the home country of the foreign GO or GE. 4.6 Bidding and Tendering Bidding and tendering are processes in which public or private hospitals, hospital systems or payers negotiate the acquisition, price and term of use of a Bio-Rad-sold product or service, and a written agreement between the manufacturer and the Customer, potential Customer, or GE is created that defines the term of use of the manufacturer s product. Bids, tenders and contracts may occur only when certain conditions are met and Bio-Rad must document and maintain records related to these requirements in accordance with the Bio-Rad Records Management program. Accordingly, bids, tenders and contracts must comply with this Policy as well as the specific requirements of the Bidding and Tendering SOP. 4.7 Standards for Commercial Interactions The anti-corruption standards provided in this Policy apply to interactions with commercial entities, Customers, and potential Customers who are not GOs or GEs. Bio-Rad Workforce Members or Channel Partners or Consultants may not give, offer, promise or authorize the giving of anything of value to commercial entities, Customers, and potential Customers directly or through an intermediary in order to obtain an improper commercial advantage. This prohibition bars the giving, offering, promising, or authorizing the transfer of not only cash but anything else of value. 4.8 Reporting and Non-Retaliation No Bio-Rad Workforce Members or Channel Partners or Consultants will suffer demotion or other adverse consequences for refusing to pay bribes even if the refusal to pay bribes results in the loss of business to the Company. If you believe or suspect that any Bio-Rad Workforce Member, Channel Partner, Consultant, or any other person acting for or on behalf of the Company, may have engaged in conduct 8

9 inconsistent with the Company s policies with respect to anti-corruption, you should contact your supervisor or the Compliance Officer immediately. You may also contact the Bio-Rad Integrity Helpline at Bio-Rad.Integrity.Ethicspoint.com. No Workforce Members will be penalized for reporting good-faith concerns to the Bio-Rad Integrity Helpline. 5. Healthcare Compliance Standards 5.1 General Standards for Interactions with Customers This section outlines the standards for Bio-Rad Workforce Members and Channel Partners and Consultants for interactions with Customers. Bio-Rad Workforce Members must adhere to these standards in order to ensure their personal compliance, and that of Bio-Rad, with the laws and regulations applicable to those interactions. For more detailed guidance on a given topic or compliance expectation, relevant Bio-Rad policies should be reviewed. If there is a question on any interaction with a Customer, whether or not covered by this policy, it is the responsibility of the Bio-Rad Workforce Member to seek guidance from the Corporate Compliance and Legal Departments on how to appropriately conduct that interaction to meet the spirit and intent of this Policy No Quid Pro Quo: All Bio-Rad Workforce Members and Channel Partners and Consultants are subject to anti-corruption requirements of this Policy, anti-kickback laws and relevant industry guidance when interacting with Customers. These interactions must not involve any discussions around, or imply, offer or provide a quid pro quo or a benefit to a Customer, dependent or other deciding or influencing party around the purchase, use or recommendation of a Bio-Rad product. Specifically, Bio-Rad Workforce Members and Channel Partners and Consultants may not ask, directly or indirectly, for use, purchase, or recommendation of a Bio-Rad product in return for a payment, gift, sponsorship, or other benefit to a Customer, foreign business counterparty, GO or GE, or any other individual or entity with influence on these decisions. Unless explicitly permitted under local Bio-Rad policies and the applicable laws and regulations, this requirement applies when interacting across country or regional borders Privacy of Protected Information: Bio-Rad requires that personal data in its care be protected in compliance with applicable data privacy laws and regulations, including laws protecting health (e.g., HIPAA in the United States) and personal information (e.g., EU Data Privacy Directive). As a general principle, only the minimal necessary protected information should be obtained, used and retained by Bio-Rad and its Channel Partners and Consultants. For example, Bio-Rad may obtain, transfer and/or store protected health information of patients or protected information of physicians, business partners and customers if it can comply with the laws and regulations applicable for that information. Such information may not be disclosed to third parties or used for another purpose unless such uses or disclosures are specifically permitted or unless Bio-Rad obtains individualized written authorizations from the individual whose information has been provided Disclosure of Relationship with Bio-Rad: Bio-Rad must fully disclose the nature of its relationships with Customers to applicable regulators and associations as required by applicable laws, regulations and industry codes. Examples of such relationships may include fee for service activities, conference and congress sponsorships, educational grants, or product research. This disclosure requirement may also include pre-approval requirements around entering into such relationships as a required under local law or codes Training: Bio-Rad is committed to thoroughly train its Workforce Members and Channel Partners and Consultants, as appropriate, in order to equip them with the knowledge and 9

10 skills necessary to perform their job functions in compliance with all applicable laws and regulations, and in conformance with the highest standards of integrity and compliance. Bio-Rad develops, administers, oversees, and tracks job-specific training as well as specific compliance training programs relating to laws and regulations, Bio-Rad policies and SOPs, industry guidelines, and other applicable guidelines. Bio-Rad Workforce Members are required to fulfill these training requirements. Bio-Rad reviews and updates such training content annually to reflect changes in policies, processes and regulatory requirements, and address any enhancement opportunities discovered during audits, monitoring or review, and any other relevant information Spend Transparency: All transfers of value, including fees, meals, hospitality, travel and sponsorships from Bio-Rad to Customers, and other covered recipients as defined by applicable spend transparency requirements, must be captured, processed and disclosed in line with the requirements of Bio-Rad s Global Spend Transparency Policy and other applicable spend transparency policies Involvement of Legal Counsel: Bio-Rad Workforce Members should consult with The Legal Department for support or further direction on legal matters related to this Policy. 5.2 Promotional Interactions with Customers This section outlines Bio-Rad s general rules concerning the creation and delivery of promotional messaging to Customers. All promotional messaging to Customers must comply with relevant Bio-Rad policies and SOPs including the Promotional Materials Review SOP, applicable laws, regulations and industry codes Accurate and Balanced Promotional Information: All written and verbal promotional communications must be clear, legible, accurate, balanced, fair, and complete to allow recipients to form their own opinion of the value of the promoted product. Furthermore, promotion of Bio-Rad products must be truthful and not misleading and should include all information and disclaimers as required by applicable laws and regulations Approved Use of Products: All promotional communications by Bio-Rad, whether written or verbal, must be consistent with the approved use, functionality, and specifications of the product in accordance with applicable regulatory requirements and industry guidance ( Approved Use ). Promotion must encourage the Approved Use of products and unless specifically authorized, Bio-Rad Workforce Members and Channel Partners and Consultants are prohibited from engaging in interactions with Customers relating to unapproved uses or capabilities of products outside the Approved Use for the product, or referring to unapproved uses of products in a promotional or commercial capacity. Promoting or soliciting unapproved uses of products may result in noncompliance with applicable laws and penalties for the Company and individual Workforce Members Substantiation: Promotion should be capable of substantiation either by reference to the Approved Use or by scientific evidence, and should focus on improving patient care, facilitating the safe and effective use of products, improving patient awareness, and educating Customers regarding the use of products. Relevant evidence should be made available upon request of Customers in order to substantiate Bio-Rad promotional messaging Approved Promotional Aids: Bio-Rad may provide promotional aids to Customers provided these items are permissible according to local laws and industry codes. All promotional aids, and the promotional messaging in these materials, must be approved in line with the Promotional Materials Review SOP and must be consistent with the 10

11 products Approved Use. Bio-Rad Workforce Members or Channel Partners and Consultants must not prepare or use homemade promotional aids, including altered versions of approved materials, any type of handwritten or printed materials addressing specifications, performance, uses or benefits of Bio-Rad products Provision of Reimbursement and Health Economics Information: Workforce Members may provide economic efficiency and reimbursement information to Customers related to Bio-Rad products. This information must be limited to identifying appropriate coverage, coding, or billing of Bio-Rad products and related procedures No Improper Influence: Promotional activities must never compromise the independence of decisions made by Customers in using Bio-Rad products for patients, or the use, purchase, or recommendation of Bio-Rad products. 5.3 Meals and Entertainment This section applies to all activities for which Bio-Rad or its Channel Partners or Consultants provide food or beverages ("Meals ) or hosting Customers for social, cultural or other leisure activities ( Entertainment") in connection with a scientific or business, educational event, presentation or discussion General Guidelines: Bio-Rad may provide, or reimburse for, Meals to Customers as part of legitimate business activities such as promotional or educational programs, meetings or sponsorships. However, Meals must never be provided as an inducement or reward for business, or in exchange for any other type of quid pro quo from the recipient. All meals must comply with the Bio-Rad Travel and Related Expense Policy and the Meals and Entertainment SOP Applicable Limits and Thresholds: The occasional provision or receipt of Meals with current or potential customers, or with business partners, is permitted, provided the Meals are not frequent, the value of such Meals is modest and the primary purpose is to have legitimate business or educational discussions. The definition of modest will often depend on circumstances surrounding the event, such as time of day, venue, and region or country. The potential activities and their respective Meal limits are outlined in Appendix 1 on this Policy Prohibition on Entertainment: As a general rule, Bio-Rad may not provide or pay for standalone Entertainment. In addition, Bio-Rad may not provide or pay for recreational or cultural events, such as tours, concerts, theater, sporting events or other similar activities as part of side events to business activities involving meetings, other than incidental Entertainment as part of the business activity. In the case of doubt on addressing special circumstances of an event, Bio-Rad Workforce Members should seek guidance from Corporate Compliance Prohibition on Guests: Bio-Rad may not provide, pay for, or arrange Meals or other form of hospitality for any individuals who do not have a legitimate business purpose to attend the event or meeting. Depending on the location of the meeting or event, this may include, but it is not limited to, office and administrative staff, spouses and family members of Customers, and other guests of Customers Documentation: Bio-Rad Workforce Members or Channel Partners or Consultants hosting a business Meal or similar activity must retain all supporting documentation, such as itemized receipts and attendance lists or sign-in sheets. 11

12 5.4 Visits to Company Facilities and Other Travel Bio-Rad may pay expenses of or reimburse Customers to visit Company facilities, or the facilities of other Customers. Such arrangements require the approval of Corporate Compliance and may be paid or reimbursed based on the following conditions: The travel must be for a legitimate business purpose, such as meetings to discuss Company regulatory issues or to demonstrate or test Company products. There must be circumstances that make the travel of the Customer preferable from a business standpoint instead of bringing the products to the customer. The expenses must be related entirely to the contemplated business, may not last longer than is necessary for the business conducted, and must not include any Entertainment. Travel may not include spouses, family members or other guests of Customers. Travel expenses must be reasonable and, unless otherwise approved by Corporate Compliance, comply with the Bio-Rad Travel and Related Expense Policy. Travel expenses may only be reimbursed against appropriate receipts or equivalent documentation. Meals provided to Customers as part of visits to company facilities must comply with the limits outlined in Appendix I of this Policy. Payments should be made directly to the hotel, airline, or service provider whenever possible. Cash may never be transferred to the customer for any reason. Per Diem payments are strictly prohibited. Approved in advance by Corporate Compliance. 5.5 Gifts to Customers This section outlines Bio-Rad s general rules concerning gifts and provides guidance on the acceptability of gifts that may be provided by Bio-Rad Workforce Members and its Channel Partners and Consultants to Customers Prohibited Items: Bio-Rad may not give Customers any type of non-educational branded promotional items, regardless of their value or potential of being used related to the Customer s work or for the benefit of patients. Examples of such non-educational branded promotional items include pens, notepads, mugs, and other items that have a Bio-Rad s name, logo, or the name or logo of one of its products. For more guidance, please refer to the Gifts SOP. Receiving a gift from a customer is also not permitted and must be reported to the Workforce Member s immediate supervisor or manager. If Workforce Members are invited to participate in a business-appropriate activity, the Workforce Members must pay for their participation only after receiving approval from their immediate supervisor or manager Permitted Items: Permitted gifts may include Bio-Rad product brochures, educational gifts and external memory units with product catalog brochures, however, any such item should have a fair market value consistent with the limits outlined in Appendix I of this Policy and meet the following criteria: Legal under local law and permissible under applicable industry guidance; In accordance with local business customs; Not excessive in value; Infrequent; and Appropriate for the occasion 12

13 In addition, certain gifts may require pre-approval as per the applicable Bio-Rad local Policies. For the purposes of this Policy, Bio-Rad products used for evaluation and demonstration purposes are not considered gifts Medical Education Items: Where permissible according to local laws and industry codes, including the AdvaMed Code of Ethics on Interactions with Health Care Professionals, Bio-Rad may occasionally provide items to Customers that benefit patients or serve a genuine educational function. Medical Education Items should have a fair market value consistent with Appendix I of this Policy. 5.6 Fee for Service Arrangements This section applies to all activities for which Bio-Rad directly, or indirectly through a Channel Partner or Consultant, procures services from Customers to assist Bio-Rad in achieving its corporate objectives. Examples for activities relevant to Fee for Service ( FFS ) Arrangements include Bio-Rad sponsored meetings such as advisory boards or educational programs, training programs, advisory services, individual consulting arrangements or market research Annual Planning: Bio-Rad encourages all business functions that have a legitimate business purpose to engage with Customers to develop an annual plan that assesses the Company s needs on specific business activities involving FFS Arrangements. The annual plan is recommended to develop and maintain as a written document to outline the Company s strategic business objectives and its business needs for contracting with Customers for industry knowledge, experience, and expertise. The annual plan is also recommended to outline the number of FFS Arrangements planned for the upcoming year, the number of Customers to be engaged as part of these FFS Arrangements and the associated budgets. Any fee for service arrangement not included in the approval plan is recommended to be reviewed and approved through the exception process outlined in the Fee for Service Arrangements SOP Legitimate Business Purpose: Bio-Rad will engage Customers in FFS Arrangements only if there is a legitimate business purpose for the FFS Arrangement. Examples of an acceptable legitimate business purpose are: Developing commercial and product development strategies; Providing Customers education and instructions on the use or other aspects of Bio- Rad products; and Other legitimate scientific, educational or business topics relevant to Bio-Rad No Quid Pro Quo: Bio-Rad must not conduct FFS Arrangements with the intent to encourage or reward Customers to use, purchase, or recommend Bio-Rad products or to gain any other improper advantages for Bio-Rad. Compensation paid to Customers for their engagement in FFS Arrangements cannot be dependent on any explicit or implicit agreement or understanding to use, purchase, or recommend a Bio-Rad product, or to reward past or future purchases of a Bio-Rad product Qualifications and Expertise: Bio-Rad must choose Customers based on their qualifications and expertise and based on the approved legitimate business purpose of FFS Arrangement. The assessment on consultant qualifications and expertise must be based on the years of professional expertise in the medical field, publications, speaking experience, and standing in the industry as a key opinion leader as well as experience with, usage of, or familiarity with a Bio-Rad product Consultant Eligibility: Bio-Rad shall screen and/or oversee screening of all prospective and current Customers against the available debarment and exclusion lists prior to engaging their services, and at least annually thereafter for ongoing FFS Arrangements. 13

14 An individual or entity is considered ineligible if they meet either of the following conditions: An individual or entity is currently excluded, debarred, suspended or otherwise ineligible to participate in health care programs or in procurement or nonprocurement programs; or An individual or entity has been convicted of healthcare program related fraud and/or patient abuse in connection with a healthcare program. In addition to the screening performed by Bio-Rad, all prospective and current Customers are required to disclose to Bio-Rad whether they are ineligible based on the above standards Venue: In the situation when a FFS Arrangement involves a Bio-Rad meeting or event, the venue must be conducive to the exchange of scientific, educational or product information. Lavish or extravagant venues must not be used and venues known for their entertainment facilities must be avoided. Improper venues include: Hotels and resorts with a high luxury rating (e.g., those with a five-star or similar rating from a national or international rating service). Specific examples of prohibited luxury hotels include the Ritz Carlton, the Four Seasons, the St. Regis, and the Mandarin Oriental chains of hotels; Hotels and resorts that lack a high luxury rating, but that provide facilities and services of a quality similar to high luxury rated venues; Casinos; Exclusive, luxury or renowned Spas; Amusement parks; Sports facilities; and Yachts, Ships, Ferries and River Boat Cruises. In certain circumstances, for example due to security requirements in a particular location, it may be necessary for Bio-Rad to use hotels and resorts with a high luxury rating due to security concerns in a particular location. All such exceptions must be approved in advance by Corporate Compliance Fair Market Value: Compensation paid under FFS Arrangements must be consistent with Bio-Rad s established rate cards for the services. The FMV assessment should take into account the consultant s credentials, qualifications, expertise and geography as well as local guidelines and limits Minimum Number: Bio-Rad should only engage the minimum number of Customers needed for the services to be completed as part of the FFS Arrangements Conflict of Interest: Bio-Rad must avoid engaging Customers who have a conflict of interest ( COI ) between their independent judgment for the contracted duties and their actual or potential associations. Customers engaged for FSS Arrangements must disclose any potential COIs to Bio-Rad prior to the execution of the contracts or as soon as such COI arises during the provision of services Appropriate Training: Occasionally, a FFS Arrangement may require a Customer to provide services as a speaker at an educational event or other roles that may involve the dissemination of promotional messages or scientific content to other Customers on behalf of Bio-Rad. In this situation, the Customer may be required to receive training on Bio-Rad promotional messaging guidelines about the specific material presented, compliance expectations, and the consistency of the information presented that is appropriate for the targeted audience. 14

15 Disclosure Requirements: Customers engaged by Bio-Rad in FFS Arrangements must make all disclosures on these FFS Arrangements required by local and regional laws, regulations, and codes Written Agreement: All FFS Arrangements require a written agreement between Bio- Rad or its Channel Partner or Consultant and the Customer before services are provided and prior to any payment being made. Written agreements should include the following information: Description of the scope of work to be performed; Fees and payment terms; Requirement of disclosure requirements to be performed by the Customer; Expense reimbursement terms; and Compliance obligations of the Customer. All written agreements must utilize the latest available templates approved by the Legal Department Proof of Performance: Bio-Rad may only make payment under a FFS Arrangement when adequate proof of performance has been obtained from the Customer. Proof of performance may include, but is not limited to, the following: Work product as specified in the written agreement; Sign-in sheets for events or meetings; Post event evaluation forms; and Meeting minutes and discussion notes Travel, Meals, and Expenses: All travel, Meals and other expenses paid for directly by Bio-Rad or reimbursed to Customers must adhere to the relevant standards outlined in this Policy. For all meetings and events organized as part of FFS Arrangements, all Meals must be incidental to the business purpose of the meeting. Reasonable travel costs and modest lodging for the Customer may be paid or reimbursed in line with Bio- Rad s Travel and Related Expense Policy. Incremental costs associated with guests or family of the Customer may not be paid for or reimbursed by Bio-Rad. 5.7 Funding of Third Party Meetings This section outlines Bio-Rad s general rules concerning Bio-Rad Paid Funding of Third Party Meetings. Such meetings may include conferences sponsored by medical associations, professional society meetings, trade shows, exhibit sponsorships and independent medical educational activities. For more specific information regarding Funding of Third Party Meetings, refer to the Funding and Sponsorships of Third Party Meetings SOP Annual Plan: Bio-Rad encourages business functions engaged in funding of third party meetings to develop an annual plan that outlines the Company s strategy and objectives on funding third party meetings. The annual plan is recommended to be developed and maintained as a written document that outlines the Company s medical, scientific and educational priorities, the amount of funding available for each type of activity, specific third party events to be sponsored as applicable, and specialties General Requirements: Bio-Rad Paid Sponsorships of Third Party Meetings are events funded by Bio-Rad in whole or in part where a Third Party has control over the arrangements, agenda, location, attendee selection, speakers and content of the meeting. Meetings whereby one or more of these aspects are controlled by Bio-Rad are Bio-Rad Sponsored Meetings and must follow the guidelines in the FFS Arrangements section of this Policy. 15

16 5.7.3 Types of Supported Third Party Meetings: Bio-Rad may provide funding to the following third party meetings: Meeting and Exhibit Sponsorships: Financial and non-financial support for healthcare-related events or programs whereby Bio-Rad receives a tangible benefit. For example, an annual membership in a professional society, an opportunity to set up an exhibit, display table or booth at the event, recognition of Bio-Rad products on promotional materials related to the event. This type of funding is usually branded meaning Bio-Rad s, or its products, logos and names are explicitly displayed recognizing Bio-Rad as a sponsor. Independent Medical Education Grants: Non-promotional funding provided without an agreement or intent to receive a tangible benefit in exchange provided to reputable healthcare organizations delivering independent medical education program. This type of funding is always non-branded meaning Bio-Rad s, or its products, logos and names are not displayed at the event Legitimate Business Purpose: All Bio-Rad Funding of Third Party Meetings must comply with the following general requirements: The event must have a clear medical or scientific character in line with an Approved Use of Bio-Rad equipment; and The event must be well recognized and perceived by the medical and scientific community Recipient Eligibility: Bio-Rad shall screen and/or oversee screening of all prospective recipients against the available debarment and exclusion lists prior to releasing the funding. For unsolicited funding requests, such as independent medical education activities, all applicants are required to disclose to Bio-Rad whether they are ineligible based on Bio-Rad s standards Written Agreement: All funding activities require a written agreement between Bio-Rad or its Channel Partner or Consultant and the Customer before the funding is released. Written agreements should include the following information: Description and amount of the funding or support to be provided; If applicable, tangible benefit Bio-Rad will receive from the funding activity; Disclosure requirements of Bio-Rad and the recipient; and Compliance obligations of the recipient. All written agreements must utilize the latest available templates approved by the Legal Department Prohibited Practices: Funding of Third Party Meetings are not permitted if the sponsorship is: Intended as a price term or offered in place of a price concession during interactions with Customers; Contingent on the use, purchase, or recommendation of any Bio-Rad products; Intended to encourage the recipient to use, purchase, or recommend Bio-Rad products or to reward the recipient for using, purchasing, or recommending Bio-Rad products; or Provided to benefit the interests of individual Customers Funding for Third Party Meetings: Funding for Bio-Rad Paid Sponsorships of Third Party Meetings must be documented in writing, cover only items relevant to the program, be provided directly to the conference organizer, and must comply with all applicable transparency and disclosure requirements, especially requirements related to income tax laws. 16