Glossary of Definitions

Transcription

1 Glossary of Definitions For purposes of MAPP, the terms listed below have the following meaning: Advisory Board: means a specific type of consultancy engagement where experts are engaged to offer advice and provide expertise on a topic and participants or institutions are contracted and may be paid for services rendered. Beneficiary: means any individual other than the Requestor, Recipient or a Controller of an entity that would receive funds or benefits from Pfizer, who would receive a direct benefit from the funds or benefits provided by Pfizer. For example: (1) where Pfizer is asked by a hospital board member to provide a donation to the hospital in order to fund the research of a specific doctor, the doctor is the Beneficiary; (2) where Pfizer is asked by a charitable organization to provide funds for an award given for medical excellence and the award recipient is known to the Initiating Colleague at the time that the funding request is processed, the award recipient is the Beneficiary; and (3) where Pfizer is asked to donate specialized medical equipment to a hospital and there is a distinct group of doctors uniquely positioned to benefit from the donation (e.g., Pfizer donates software developed for cardiologists and the hospital has three cardiologists), such doctors would be the Beneficiaries. If a grant or donation is provided to a hospital for use by all of its doctors (e.g., a subscription to a professional medical journal), the hospital s doctors are not Beneficiaries. Business Development Transaction: means any of the following: (i) acquisitions or mergers of (1) equity interests of an entity, or (2) assets constituting substantially all of an entity s business operations; (ii) divestitures or sales of (1) Pfizer subsidiaries, or (2) assets constituting substantially all of a Pfizer subsidiary s business operations; (iii) Joint Venture Transactions; (iv) Co-Promotion Agreements; or (v) venture capital, private equity and other investments in equity or debt securities of entities located in a country listed in Column B of Appendix 1. Basic Review Transaction: means a category of Third Party Transaction as defined in the Third Party Transactions chapter of MAPP. Blue Book: Pfizer s global Code of Conduct. Charitable Contribution or Business Donation: means the provision of funding, equipment or free products other than Educational or Research Grants or Corporate Sponsorships to a third party entity to support public interest activities. Charitable Contributions are made to charities while Business Donations can be made to other types of entities (e.g., hospitals or institutions). Colleague: means a Pfizer employee. Consultancy or Services Arrangement: means the provision of consulting or other services by an HCP or GO pursuant to an agreement with Pfizer. 1

2 Contracted/Outsourced Sales Force: means a Third Party entity that supplies a sales force to Pfizer that performs sales and marketing services on behalf of Pfizer where Pfizer has contracted for such sales force services. Controller: means any individual who holds a formal leadership position (e.g., any board member or officer) with an entity receiving funding or financial support from Pfizer or who is in a position to influence such entity through an informal role (e.g., an advisory board member). If the Initiating Colleague knows of other individuals in other roles who have a similar ability to exert control over the entity with respect to the proposed funding (e.g., Pfizer funds a scholarship and the identity of the individual who selects the winner is known to Pfizer) or senior employees of the entity tasked with soliciting or distributing funding on behalf of the entity, then such individuals should also be examined as Controllers. Co-Promotion Agreement: means an agreement between Pfizer and one or more business partners to promote one or more products each under one trademark and with coordinated marketing activities. One party will usually manufacture, distribute and book sales and the other party or parties will receive a fee or other financial compensation for their efforts. Corporate Sponsorship: means the provision of funding or products from Pfizer to a third party entity in support of a project (such as, but not limited to, events, publications and meetings which are not otherwise supported by an Educational Grant) where the primary purpose of the support is an opportunity to promote Pfizer s products, brands or business. Country Profile: means a profile for a country/region containing country-specific information relevant to MAPP and maintained on the Pfizer website available at Cross-Border Transaction: means any interaction or transaction involving a Government Official where (a) the Initiating Colleague is located in a country other than the GO s Home Country or (b) the interaction or transaction is reasonably expected to occur in a country other than the GO s Home Country. Dispensing Entity: means an entity, such as a hospital or pharmacy, that dispenses Pfizer products to a customer. Distributor: means a Third Party that purchases products from Pfizer for resale, where the resale price to the market is determined by Pfizer. A Distributor will often have exclusivity over brand, geography, and/or sales channel, and may be involved, on behalf of Pfizer, in sales and marketing and completing regulatory processes. Division: means any Pfizer organization headed by a Pfizer Executive Leadership Team member or any other organization granted Divisional status by the Pfizer Executive Leadership Team. Educational Grant: means funding provided by Pfizer to support a bona fide, independent educational program in areas of interest to Pfizer, such as medical science or public health, where the primary purpose of the support is the provision of such legitimate educational program and not an opportunity to promote Pfizer s products, brands or business. End-User: means a person or entity that uses, rather than sells or dispenses, Pfizer products, including healthcare professionals, patients or consumers. 2

3 Enhanced Review Transaction: means a category of Third Party Transaction as defined in the Third Party Transactions chapter of MAPP. Entertainment: means activities with little or no independent scientific, healthcare policy, or legitimate Pfizer business related relevance or value, such as sporting events or other leisure activities including theater, concerts, sightseeing tours or karaoke. Family Relative: means a parent, spouse, child or sibling (including any such relationships formed by marriage). FCPA: means the U.S. Foreign Corrupt Practices Act of 1977, as amended. Gift: means an item that is provided to an individual free of charge without any expectation of something in return. Global Anti-Corruption Laws: means non-u.s. anti-bribery and/or anti- legislation, including the U.K. Bribery Act, the People s Republic of corruption China Criminal Law, and the laws of the countries that have signed the United Nations Convention Against Corruption (UNCAC). Global Approved Third Party List: means the global list of approved Third Parties for purposes of the Third Party Transactions chapter of MAPP. GO s Home Country: means the country for which a Government Official holds such role or employment. Government: means all levels and subdivisions of governments (i.e., local, regional, or national and administrative, legislative, or executive). Government Official ( GO ): shall be broadly interpreted and means: (i) any elected or appointed non-u.s. Government official (e.g., a legislator or a member of a non-u.s. Government ministry), (ii) any employee or individual acting for or on behalf of a non-u.s. Government official, non-u.s. Government agency, or enterprise performing a function of, or owned or controlled by, a non-u.s. Government (e.g., a healthcare professional employed by a non-u.s. Government hospital or researcher employed by a non-u.s. Government university), (iii) any non-u.s. political party officer, candidate for non-u.s. public office, or employee or individual acting for or on behalf of a non-u.s. political party or candidate for public office, (iv) any employee or individual acting for or on behalf of a public international organization, (v) any member of a royal family or member of a non-u.s. military, and (vi) any individual otherwise categorized as a Government Official under applicable Local Laws or Pfizer Policies. GPIHP: Pfizer s Global Policy on Interactions with Healthcare Professionals. Green Guide: means the policy setting forth governance for field-based medical activities for certain Colleagues. 3

4 Healthcare professional: means physicians, nurses, pharmacists and others who may administer, prescribe, purchase, or recommend pharmaceutical products or other healthcare products. HCP: means a non-u.s. healthcare professional. Host Country: means the country where a Pfizer Organized or Third Party Meeting or Site Visit is being held. IGO: means an individual that will provide payments or benefits to, or seek to influence, Government Officials or a non-u.s. Government on Pfizer s behalf. IIR: means Investigator-Initiated Research that meets the requirements of Investigator-Initiated Research SOP (CT25). Initiating Colleague: means the Colleague who is requesting financial support to or an engagement with a third party or seeking to offer a Pfizer Employment Opportunity as set forth in MAPP and who is responsible for ensuring that such support, engagement, or offer is in compliance with Pfizer Policies and Local Restrictions. International Travel: means travel across an international border. Investigator Meeting: means a meeting for clinical trial investigators and/or site staff to educate them on the clinical trial protocol and procedures during the life of a study where the individual attendees are not contracted because a contract already exists between Pfizer and the participating site and the attendees are not paid for services rendered for participation. INSPIIRE: means the single global Investigator Initiated Research Management system known as the Integrated System for Pfizer Investigator Initiated Research. It is used to centrally record all submitted proposals, internal decisions and to archive required documentation under the Investigator-Initiated Research SOP (CT25) or Requests for Pure Substance SOP (CT15). Joint Venture Transaction: means an agreement between Pfizer and one or more third party business partners to form a new entity over which Pfizer and those business partners jointly exercise control and share revenues, expenses and assets. KDME List: means the list of KDMEs for a particular country. Key Decision Making Entity ( KDME ): means a Government entity, including but not limited to any entity acting on behalf of a Government, which makes decisions, either within or on behalf of a country, which can have a significant effect on Pfizer s business. This includes, but is not limited to, decisions regarding regulatory, reimbursement, or market access matters, inclusion of Pfizer vaccines in a National Immunization Program and public tenders for government sales or contracts. KDME does not include Government hospitals when making decisions regarding product purchases for themselves. Local GO Category List: means the categories of individuals considered Government Officials under Local Law or Pfizer Policies in a country. Local Laws or Local Law: means any laws or regulations, operating procedures (including requirements imposed by Government entities such as 4

5 Government-owned hospitals or research institutions), or industry codes of conduct or practice that are applicable to Pfizer activities in a country. Local Restrictions: means any limits, restrictions, or disclosure requirements imposed by Local Law or Pfizer Policies in a country with respect to interactions or transactions with Government Officials. MAPP SOPs: means written local or regional procedures implementing MAPP. Market Reviewer: means a non-commercial Colleague (e.g., Medical, Finance or Legal), identified to provide information with regard to decisions or matters before a PIGO from his or her country. NIP PIGO: means a Government Official who holds a position where he or she could influence a decision to purchase vaccines on a national/regional level or approve an official act to include a Pfizer vaccine in a National Immunization Program. Orange Guide: Pfizer s Field Guide. Pfizer Employment Opportunity: means the offer of employment as a Colleague, whether paid or unpaid, or promotion of an existing Colleague. Pfizer Organized Meeting: means a meeting organized by Pfizer or an agency on Pfizer s behalf. This may include managing the content of the meeting/agenda or choosing the speakers and/or approving the content of presentations. Pfizer Policies: means MAPP and any other corporate, divisional, regional or local Pfizer policies or procedures which are applicable to the specific activities conducted by Pfizer in a country. The term includes MAPP SOPs. Political Contribution: means funding or support provided to a properly established and recognized political party in a country outside the United States for general funding purposes or to support a particular campaign, or to a candidate for public office or an election committee in a country outside the United States for the purpose of funding an election campaign or searching for an election candidate. Potentially Influencing Government Official ( PIGO ): means an individual who is either: (i) connected to a KDME as a member of its management or governance body or as an employee or consultant on Pfizer matters, or (ii) otherwise in a position where he or she could make a decision that will significantly impact Pfizer s business, other than, if applicable, merely as a practicing HCP (examples of such decisions include approval of product registration or licenses or marketing authorizations, approval of pricing or reimbursement of a product, awarding public tenders for government sales or contracts, including products within drug or product formularies or rotation schedules, recommendations for vaccinations to be included in government immunization programs, and granting licenses or permits required to operate or conduct business (i.e., by regulatory agencies)). 5

6 Preceptorship: means an engagement by Pfizer of HCPs to train Pfizer colleagues. Event may take place in a number of locations, including but not limited to, institutions, hospital settings, virtual setting, or Pfizer site. Principal Manager: means, unless otherwise agreed with the Program Office, the most senior Pfizer manager in a country for each Business Unit or Division with operations in that country. For Regional Functions with business responsibility for more than one country, the Principal Manager for Colleagues within the regional function is the most senior manager of the function in the region unless otherwise agreed with the Program Office. For enabling functions, unless otherwise agreed with the Program Office, the Principal Manager is the most senior manager of the global function or his or her designee of appropriate seniority. Program Office: means the Compliance Division s Anti-Corruption Program Office. Purple Guide: means the policy setting forth governance of medical outcome specialists activities. Recipient: means the third party entity, or in the case of a Research Grant, a third party entity or individual, that would receive funds or benefits directly from Pfizer. Requestor: means a non-pfizer individual who solicits proposed funding or benefits from Pfizer. Research Grant: means funding, products or other support offered by Pfizer to third party entities or individuals for the purpose of the advancement of medical or scientific knowledge, whether or not the research is related to an area of commercial interest for Pfizer, where Pfizer is not the sponsor or co-sponsor of the research (e.g., sponsored clinical trials) and the research is not being done on behalf of Pfizer. Restrictive Country: means a country whose Local Restrictions may extend beyond the territory of the country. A list of these countries may be found on the Country Profile webpage. Retailer: means a Third Party that purchases products from Pfizer or our Wholesaler, Distributor or Sales Agent for resale to the final consumer, where the resale price to the market is determined by the retailer with no control by Pfizer. Retailers will not have exclusivity over brand, geography or sales channel. Review Transaction: means those transactions identified as Review Transactions in the Third Party Transaction chapter of MAPP. Sales Agent: means a Third Party that purchases products from Pfizer for resale in a market where Pfizer does not have or operate under a legal entity that performs sales and marketing, regulatory and other services on behalf of Pfizer. Sales Intermediary: means any Third Party that sells or markets Pfizer products on Pfizer s behalf outside the U.S., other than (1) Retailers and Wholesalers that do not engage in sales and marketing on Pfizer s behalf and (2) Dispensing Entities and End-Users. This includes, but is not limited to, Distributors, copromote or joint venture partners, Sales Agents, Contracted/Outsourced Sales Force, consultants or representatives (with the requirements of the Business 6

7 Development Transactions chapter of MAPP applying to Co-Promotion Agreements or Joint Venture Transactions). Sample: means a Pfizer product provided free of charge to a hospital, institution or HCP for distribution to patients, or to HCPs or consumers (for non-prescription consumer products) so that these parties can become familiar with those products. Site Visit: means a visit to a Pfizer manufacturing or research and development site anywhere in the world by a Government Official which is not connected to: (i) an official inspection or other site visit required by law (e.g., a regulatory inspection of a Pfizer manufacturing plant); or (ii) a Consultancy or Services Arrangement with a Government Official (e.g., attending an advisory board meeting at a Pfizer R&D site) and where the main purpose of the visit is either educational, fact-finding or for official purposes such as scientific exchange, medical education or for the demonstration of a Pfizer product or service or the demonstration of a research and development or manufacturing process. Subcontractor: means any entity or individual retained or otherwise engaged by a Third Party (not including subsidiaries or affiliates owned or controlled by the Third Party) in connection with its work for Pfizer to provide payments or benefits to, or seek to influence, Government Officials or a Government. Substantial Services Arrangement ( SSA ): means a Consultancy or Services Arrangement where either: Term is for more than twelve (12) months; or Amount to be paid to the GO for the proposed engagement is expected to exceed U.S. $10,000 (or local equivalent); or Amount to be paid to the GO combined with the actual spend with that GO by the Initiating Colleague s country for the current year, or rolling 12-month spend where available, will exceed o U.S. $50,000 (or local equivalent) if the Initiating Colleague is based in a Column A Country in Appendix 1 o U.S. $25,000 (or local equivalent) if the Initiating Colleague is based in a Column B Country in Appendix 1 Supervisor: means the Pfizer Colleague to whom an Initiating Colleague reports directly. Symposium: means a Pfizer-initiated and/or controlled live event held at a scientific congress. The content is typically customized for the event by program faculty and Pfizer, who are paid by Pfizer for content development and if applicable, are paid for speaking at the live event. Symposia may be open-door (e.g., any congress participant may participate) or closed "invitation only" events whereby attendance is controlled. Attendees are not paid honoraria and are not asked for formal scientific feedback. Third Party: means an entity (e.g., a corporate or other legal entity, including but not limited to corporations, partnerships and Government entities) or an individual who is not a GO or HCP with whom Pfizer is engaging in a Third Party Transaction. 7

8 Third Party Meeting: means a meeting organized by a third party where Pfizer is not involved in organizing the meeting, even if Pfizer is providing financial support for the meeting. Third Party Transaction: means a transaction with a Third Party (other than a Business Development Transaction) where, in exchange for remuneration or commercial benefits, such Third Party provides or receives goods or services to or from Pfizer. Transactional Attorney: means a lawyer that, in connection with a Business Development Transaction, is assigned to draft and negotiate documentation, provide legal advice and coordinate advice and input on the transaction from the Compliance Division. VIGO: means a Third Party entity that will provide payments or benefits to, or seek to influence, Government Officials or a non-u.s. Government on Pfizer s behalf. White Guide: Pfizer s Healthcare Law Compliance Guide. Wholesaler: means a Third Party that purchases products from Pfizer for resale, where the resale price to the market is determined by the Wholesaler with no control by Pfizer. Wholesalers will not have exclusivity over brand, geography or sales channel. 8