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1 Respect for People Integrity Creativity Empowerment • Networking Courage • Sense of Urgency GLOBAL COMPLIANCE PROGRAM: Case Study June, 2004 Princeton

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Page 1: GLOBAL COMPLIANCE PROGRAM: Case StudyAVENTIS PROGRAM COMPONENTS • Global Compliance Officer designated – Board Member • Training and Education • General – (e.g., Multi-lingual

1Respect for People • Integrity • Creativity • Empowerment • Networking • Courage • Sense of Urgency

GLOBAL COMPLIANCE PROGRAM: Case Study

June, 2004

Princeton

Page 2: GLOBAL COMPLIANCE PROGRAM: Case StudyAVENTIS PROGRAM COMPONENTS • Global Compliance Officer designated – Board Member • Training and Education • General – (e.g., Multi-lingual

2

A COMPLIANCE PROGRAM…

“…an internal management system that assists employees in understanding and following targeted legal principles on an organized basis.”*

• Publish Compliance policies

• Educate employees

• Monitor employee behavior

• Discipline

*Jay G. Martin, The Lawyer’s Brief, September 30, 2002

Page 3: GLOBAL COMPLIANCE PROGRAM: Case StudyAVENTIS PROGRAM COMPONENTS • Global Compliance Officer designated – Board Member • Training and Education • General – (e.g., Multi-lingual

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ELEMENTS OF A COMPLIANCE PROGRAM

• Written standard of conduct

• Written policies/procedures committing to legalcompliance in a wide variety of areas of potentialcompliance risk

• Compliance Officer

• Training and education

• Monitoring and audits

• Investigation and remediation of problems

Page 4: GLOBAL COMPLIANCE PROGRAM: Case StudyAVENTIS PROGRAM COMPONENTS • Global Compliance Officer designated – Board Member • Training and Education • General – (e.g., Multi-lingual

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ELEMENTS OF A COMPLIANCE PROGRAM

• Hotline for complaints and procedures for anonymity

• Consideration of compliance in performance evaluationsof leaders

• Disciplinary action for violators

Page 5: GLOBAL COMPLIANCE PROGRAM: Case StudyAVENTIS PROGRAM COMPONENTS • Global Compliance Officer designated – Board Member • Training and Education • General – (e.g., Multi-lingual

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SARBANES-OXLEY ACT

• Has resulted in renewed emphasis on Compliance Programs

• New or enhanced standards for corporateaccountability and transparency – rules andinterpretation in development

• Increases penalties for corporate wrong doing

• Auditors, financial disclosures, management responsibility

Page 6: GLOBAL COMPLIANCE PROGRAM: Case StudyAVENTIS PROGRAM COMPONENTS • Global Compliance Officer designated – Board Member • Training and Education • General – (e.g., Multi-lingual

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SO WHAT ARE WE DOING?

• Aventis Values of Integrity and Courage are, as they should be, the starting point

• We expect all employees to have these values as the basis of their actions

• Realistically, that is not enough – highly complex environment, not all answers are clear

• Compliance Program assures that all of the elements arein place

Page 7: GLOBAL COMPLIANCE PROGRAM: Case StudyAVENTIS PROGRAM COMPONENTS • Global Compliance Officer designated – Board Member • Training and Education • General – (e.g., Multi-lingual

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AVENTIS PROGRAM COMPONENTS

• Written standard

• Global Compliance Policy – 9 Languages

• Written policies – for example

• US Business Conduct Policy

• Research – Quality Standards

• Industrial – Quality Standards

• Countless SOPs

Page 8: GLOBAL COMPLIANCE PROGRAM: Case StudyAVENTIS PROGRAM COMPONENTS • Global Compliance Officer designated – Board Member • Training and Education • General – (e.g., Multi-lingual

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AVENTIS PROGRAM COMPONENTS

• Global Compliance Officer designated – Board Member• Training and Education

• General – (e.g., Multi-lingual Compliance Policy Overview e-learning on Website)

• Issue Specific varies by country – new globale-learning modules re: antitrust/bribery

• Website

• Global site with links to function and country specificpolicies

Page 9: GLOBAL COMPLIANCE PROGRAM: Case StudyAVENTIS PROGRAM COMPONENTS • Global Compliance Officer designated – Board Member • Training and Education • General – (e.g., Multi-lingual

9http://compliance.pharma.aventis.com

Page 10: GLOBAL COMPLIANCE PROGRAM: Case StudyAVENTIS PROGRAM COMPONENTS • Global Compliance Officer designated – Board Member • Training and Education • General – (e.g., Multi-lingual

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What you can find here:

• Global Compliance Policies• Country-Specific Policies• Compliance Helpline Information

• Functional Policies & SOPs

• Training Materials• Links to Regulatory Sites

• Report Compliance Concerns

Page 11: GLOBAL COMPLIANCE PROGRAM: Case StudyAVENTIS PROGRAM COMPONENTS • Global Compliance Officer designated – Board Member • Training and Education • General – (e.g., Multi-lingual

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Connecting You to:

Internal & External Compliance & Regulatory Sites

Page 12: GLOBAL COMPLIANCE PROGRAM: Case StudyAVENTIS PROGRAM COMPONENTS • Global Compliance Officer designated – Board Member • Training and Education • General – (e.g., Multi-lingual

12Helping us uphold our Values

Available to all Aventis

24 hours a day / 7 days a week

Multi-LingualToll-Free

ConfidentialAnonymous

associates globally

Page 13: GLOBAL COMPLIANCE PROGRAM: Case StudyAVENTIS PROGRAM COMPONENTS • Global Compliance Officer designated – Board Member • Training and Education • General – (e.g., Multi-lingual

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From theGlobal Legal Compliance

Homepage

Page 14: GLOBAL COMPLIANCE PROGRAM: Case StudyAVENTIS PROGRAM COMPONENTS • Global Compliance Officer designated – Board Member • Training and Education • General – (e.g., Multi-lingual

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AVENTIS PROGRAM COMPONENTS

• Investigations

• Handled locally

• Developing Web-based tool for country reportingto make global trend overview possible

Page 15: GLOBAL COMPLIANCE PROGRAM: Case StudyAVENTIS PROGRAM COMPONENTS • Global Compliance Officer designated – Board Member • Training and Education • General – (e.g., Multi-lingual

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AVENTIS PROGRAM COMPONENTS

• Hotline

• Compliance Helpline

• 1-800-XXX-XXXX

• Available globally

Page 16: GLOBAL COMPLIANCE PROGRAM: Case StudyAVENTIS PROGRAM COMPONENTS • Global Compliance Officer designated – Board Member • Training and Education • General – (e.g., Multi-lingual

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COMPLIANCE OFFICER RESPONSIBILITES

• Oversee and monitor the implementation of ComplianceProgram

• Revise the Compliance Program if necessary

• Assure the development of appropriate education andtraining programs

• Report to Management and Supervisory Boards onCompliance Program progress and issues

Page 17: GLOBAL COMPLIANCE PROGRAM: Case StudyAVENTIS PROGRAM COMPONENTS • Global Compliance Officer designated – Board Member • Training and Education • General – (e.g., Multi-lingual

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COMPLIANCE OFFICER RESPONSIBILITES

• Investigate and act on compliance issues (coordination with Audit where appropriate)

• Assure development of policies and programs for reporting of suspected violations without fear of retaliation

• Ensure appropriate reporting of self-discovered violations

Page 18: GLOBAL COMPLIANCE PROGRAM: Case StudyAVENTIS PROGRAM COMPONENTS • Global Compliance Officer designated – Board Member • Training and Education • General – (e.g., Multi-lingual

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HOW DOES THE GCO KNOW HOW DOES THE GCO KNOW WHAT IS GOING ON?WHAT IS GOING ON?

Aventis Global Compliance Structure– Established network of country and function based contacts

Reporting on semi-annual basis and as needed– Leverages existing strong cross functional committees

Linkage through participation by legal team– Leverages existing business unit structures – Designates dedicated legal team to support efforts

Coordination reporting, training development, counsel to committees

Reporting Periodically to Management & Supervisory Boards

Page 19: GLOBAL COMPLIANCE PROGRAM: Case StudyAVENTIS PROGRAM COMPONENTS • Global Compliance Officer designated – Board Member • Training and Education • General – (e.g., Multi-lingual

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Global Compliance StructureGlobal Compliance Structure

Management Board

Global Compliance Officer

Functional Liaison withRisk Council Members

On Compliance risks and compliance related processes

Country / Regional Compliance Officers,

Committees / Contacts

Global Legal Compliance

Supervisory Board/Audit Committee

Global Compliance Committees & Offices

Independent Business Units

Page 20: GLOBAL COMPLIANCE PROGRAM: Case StudyAVENTIS PROGRAM COMPONENTS • Global Compliance Officer designated – Board Member • Training and Education • General – (e.g., Multi-lingual

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Country/Region Compliance StructureCountry/Region Compliance StructureGlobal Compliance

OfficerCountry/Region

General Manager

GlobalLegal Compliance

Country/Regional Compliance Officers/

Committees, Contacts*

CountryIndustrial

Country orRegional Legal

CountryFinance

CountryHR

CountryCom Ops

Audit groups will have input into this structure through existing routes

* Structures will vary in country or region

Country Research

Information Flowchart

Global ComplianceCommittees