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FEATURED INDUSTRY PERSPECTIVES:

Abbott • Carestream Health Inc. • CareFusion • Covidien

Endologix Inc. • Fresenius • GE Healthcare • Johnson & Johnson

Medtronic • Siemens • Wright Medical Technology

FEATURED GOVERNMENT PERSPECTIVES:

Elizabeth S. Tonkin, Assistant U.S. Attorney, ACE/Civil HCF Coordinator, Eastern District of Tennessee, United States Department of Justice

Jacob T. Elberg, Assistant U.S. Attorney, Chief, Health Care & Government Fraud Unit, U.S. Attorney’s Office, District of New Jersey, United States Department of Justice

Robert M. Lewis, Assistant U.S. Attorney, U.S. Attorney’s Office, District of Minnesota, United States Department of Justice

Neeli Ben-David, Assistant U.S. Attorney, U.S. Attorney’s Office, Northern District of Atlanta, United States Department of Justice

Media Partners:

CLE & CPE Credits Available!

Pending Approval

CCO Summit Host:

REGISTER AT WWW.CBINET.COM/MDCOMPLIANCE • 800-817-8601

ABOUT OUR CCO SUMMIT HOST

Celebrating more than 125 years of service, King & Spalding is an international law firm that represents a broad array of clients, including half of the Fortune Global 100, with 800 lawyers in 17 offices in the United States, Europe, the Middle East and Asia. The firm has handled matters in over 160 countries on six continents and is consistently recognized for the results it obtains, uncompromising commitment to quality and dedication to understanding the business and culture of its clients. For more information about our FDA & Life Sciences practice, please contact

Mark Brown at mbrown@kslaw.com or Seth Lundy at slundy@kslaw.com.

ADDITIONAL SPONSORS

A GREAT PLACE TO MEET YOUR MARKET!Take advantage of the best opportunity to meet potential clients face-to-face. Build relationships while

demonstrating thought leadership and sharing expertise. For more information on how to position your company as a sponsor or exhibitor, contact Taylor Biggers at 339 298 2108 or email taylor.biggers@cbinet.com.

Now in its 10th year, the Medical Device & Diagnostics Compliance Congress is the medical device industry’s premier and longest running event for compliance professionals to network and learn from industry thought leaders. This unparalleled forum delivers quality content and actionable

takeaways to meet the new standards of a truly effective corporate compliance program.

WHO SHOULD ATTEND:

You will benefit from attending this event if you are a Chief Compliance Officer, Chief Counsel or senior-level executive at a medical device or diagnostics company with responsibilities or involvement in the following areas:

Compliance and Ethics

Legal

Monitoring

Internal Audit

Investigations

Aggregate Spend and Transparency

This conference will also benefit laws firms and consultants who supply the industry with assistance in regulatory, compliance and legal challenges, fair market valuation, audit and technology providers with aggregate spend or master data management solutions.

“The broad range of industry experts can help any fledgling compliance department get pointed in the right direction.” — Nick Hawryschuk, Deputy Compliance Officer,

Carestream Health

“The comprehensive, timely and interactive nature of the topics covered was well worth my time.” – Tara Shewchuk, Vice President Compliance,

Medtronic Spine

“Wonderful networking opportunities, information sharing, expanding my compliance connections, tools to take back for best practices in my company.” – Susan Hanstad, Director of Corporate Compliance,

Endologix

HEAR WHAT SOME OF OUR PREVIOUS ATTENDEES HAVE TO SAY:

Compliance 54%

Legal 30%

Regulatory 6%

Sales 7%

Marketing 3%

2013 REPRESENTATION FROM CHIEF COMPLIANCE EXECUTIVES, CHIEF COUNSEL AND REGULATORY TEAMS

REGISTER AT WWW.CBINET.COM/MDCOMPLIANCE • 800-817-8601DAY ONE Tuesday, February 25, 20147:30 Main Conference Registration

8:15 Chairperson’s Opening RemarksPam Mellon, Chief Compliance Officer, Carestream Health, Inc.

8:20 Instill the Value of Compliance to the Entire Organization • Discuss how compliance can effectively

liaise with the company* overall business structure

• Improve dialogue between business and compliance

• Assess challenges associated with gaining appropriate resources to foster a culture of compliance

Daniel Garen, Senior Vice President, Chief Compliance Officer, Wright Medical TechnologyLuke Miller, Senior Vice President, General Counsel and Chief Compliance Officer, K2M, Inc.

9:00 Develop a Comprehensive Monitoring Program • Discuss preliminary considerations

for a monitoring program* what does monitoring look like at

your company?* large vs. small companies —

what do you need to consider?* utilize risk assessments and audit

activities to build a program* is the company under a CIA?

• Discuss considerations for data/information to compile and monitor * live monitoring * data analysis

Susan Hanstad, Director, Corporate Compliance, Endologix Inc.

9:40 Re-Think Risk Assessments to Enhance Compliance • Improve monitoring processes to

identify risks• Risk assessment — Fully integrate into

compliance strategies * enterprise risk* product-specific risk * individual risk

• Understand how the need for risk assessments has escalated and re-think processes for your organization

• Discuss how to handle results from risk assessments in order to demonstrate effectiveness

Moderator: Gina Cavalier, Partner, King & Spalding Susan Clarke, Director, Commercial Compliance, Johnson and Johnson Christina Rich, Vice President, Business Ethics and Compliance, Cardiac and Vascular Group, Medtronic Nancy F. Lanis, Vice President, Regulatory & Legal Affairs, Henry Schein, Inc.

10:20 Networking and Refreshment Break

10:50 Auditing and Monitoring Medical Device Distributorships — Mitigating Risk in Complex Sales Environments• Define “distributor” and understand the

responsibilities of that relationship from a compliance perspective

• Evaluate guidance from Advamed, Eucamed, OIG and others to aid in understanding compliance obligations related to distributor relationships

• Discuss three key areas of compliance risk with distributors

• Explore auditing and monitoring processes for mitigating compliance risk with distributors

Rosemary E. Weghorst, Director, Huron Life Sciences, Huron Life SciencesPeter Lux, Manager, Huron Life Sciences, Huron Life Sciences

11:30 FEDERAL ENFORCEMENT PANEL Recent Trends in State and Federal Enforcement — Complaints, Investigations and Settlements with Federal Prosecutors Settlements and investigations involving device companies for kickback and pricing violations, off-label marketing, manufacturing processes and labeling continue to make headlines. In this Government Enforcement Panel, hear directly from those involved in recent settlements and on-going investigations. • Gain insight on the government’s top priorities• Discuss and evaluate recent cases involving

medical device manufacturers• Review emerging areas of focus

Moderator: Alexandria M. Peters, Associate General Counsel, Vascular Therapies, CovidienPanelists: Elizabeth S. Tonkin, Assistant U.S. Attorney, ACE/Civil HCF Coordinator, Eastern District of Tennessee, United States Department of Justice Jacob T. Elberg , Assistant U.S. Attorney, Chief, Health Care & Government Fraud Unit, U.S. Attorney’s Office, District of New Jersey, United States Department of Justice Robert M. Lewis, Assistant U.S. Attorney, U.S. Attorney’s Office, District of Minnesota, United States Department of Justice

Neeli Ben-David, Assistant U.S. Attorney, U.S. Attorney’s Office, Northern District of Georgia, United States Department of Justice

12:15 Assess Privacy Concerns and Minimize Risks of Data Breaches • Discuss potential risks surrounding data breach • Update on regulations

* national — HIPPA and HITECH* state regulations * global/country specific privacy law

• Consider implications for medical device manufacturers as well as the entirety of the healthcare system

• Analyze the impact of audits on covered entities• Protect data through proactive activities

including adherence to new regulations globallyJacob Springer, LLM, CIPP, Division Counsel, Global Privacy Officer, Legal Regulatory and Compliance, Abbott

12:55 Networking Luncheon

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Networking, Wine and Cheese Reception Immediately Following the Final Session on Day One

1:45 Workshop Leader’s Welcome & Opening Remarks

Workshop Objective:In this workshop, experts will share lessons they’ve learned during their preparation for Sunshine reporting, and attendees will benefit by a conversation that includes benchmarking and open discussion with colleagues.

Key Questions to Be Addressed:• Are our company policies and business processes

aligned with US Sunshine?• How can we resolve the biggest challenges in order

to avoid disputes?• Do stakeholders feel prepared and invested in

accurate tracking of spend so the report is correct?• Is our company’s assumptions document robust and

involved feedback from key stakeholders?• What mechanisms are in place for changes in

decision-making for 2014 reporting and beyond?

Workshop Outline:

I. Manage Processes Beyond Data Capture and Next Phase of Reporting • Develop a checklist of material issues to

address before filing• Confirm your assumptions document is in

tip-top shape• Benchmark plan for reporting and

communication post-submission• Discuss how to get ready for publication of

the reported data

II. Key Challenges to Consider • Discuss developments affecting the

forthcoming Sunshine reporting date, including a discussion of CMS clarifications and of common issues being raised by industry

• Analyze whether or not to file an Assumptions Document

• Consider technical filing issues

III. HCP Spend Tracking • Review concerns of physicians due to

increased transparency reporting• Prepare for disputes to be filed by

covered recipients• Understand regulation surrounding

HCP payments for clinical and commercial considerations

• Discuss effective and efficient techniques to minimize disputes

5:15 Close of Breakout B and Day One

There will be a 30-minute networking and refreshment break at 3:15pm

Workshop Leader:

Christian Krautkramer, Global Compliance, GE Healthcare

Seth H. Lundy, Partner, King & Spalding

1:45 Workshop Leader’s Welcome & Opening Remarks

Summit Objective:

This Summit has been designed to encourage an open exchange of ideas and strategies surrounding some of the most critical issues facing compliance and legal departments in the life sciences industry. Participants can share their challenges in these areas, pose questions of their colleagues in these areas and come away with valuable insight into current and future compliance initiatives. An antitrust attorney is present throughout the Summit to ensure appropriate and compliant discussion among participants.

Discussion Topics Include:• Global Enforcement • Sunshine and Open Payments• Organizational Transparency • Risk Assessments and Liability • Auditing and Monitoring

5:15 Close of CCO Summit and Day One

There will be a 30-minute networking and refreshment break at 3:15pm

Summit Leader: Daniel Garen, Senior Vice President, Chief Compliance Officer, Wright Medical Technology *Open to those who hold the title of Chief Compliance Officer or an equivalent compliance leadership position (at the time of the conference) at a medical device or diagnostics company. Final eligibility approval is at the discretion of CBI.

1:55 – 5:15 Choose f rom Two In-Conference Break-Out Opt ions

THE 8TH ANNUAL INVITATION-ONLY*

Chief Compliance Officer Summit

T-30 — The Countdown to Initial Sunshine Filings

A

B

REGISTER AT WWW.CBINET.COM/MDCOMPLIANCE • 800-817-8601

DAY TWO Wednesday, February 26, 2014

7:30 Continental Breakfast

8:00 Chairperson’s Review of Day OnePam Mellon, Chief Compliance Officer, Carestream Health, Inc.

8:05 Understand the High Risk Areas in Off-Label Risks and Promotional Compliance • Review high risk areas and practices

regarding off-label promotion• Conduct a product risk assessment• Assess sales and marketing practices• Advertising and promotion review considerations• Ensure compliant field interactions

with providers • Implement appropriate live and

retrospective monitoring programs • Analyze recent enforcement activitiesModerator: Mark DeWyngaert, Managing Director, Huron Life SciencesPanelists: Jody Gleason, Assistant General Counsel, Advertising and Promotion, CareFusionTara R. Shewchuk, Vice President, Ethics and Compliance, Medtronic Spinal

8:45 Field Force Oversight — Minimize Risk in Anti-Kickback and Sunshine Reporting • Assess the impact of promotions and

considerations related to sales operations • Track inventory to reduce anti-kickback

and Sunshine risks • Review potential compliance issues caused

by compensation plans and incentive abuse• Analyze challenges associated with off-label

questions and interaction with medical affairs teams

• Discuss the importance of thorough training and communication

Candice Ciresi, Senior Corporate Counsel, Vascular Therapies, Covidien

9:25 FCPA and Due Diligence — Third Party Monitoring and High Risk Areas• Identify high risk areas, both based upon

geography and local regulations• Determine necessary levels of diligence required

for third parties and contracted entities• Review approaches to ensure due diligence

is created as a culture across the business• Assess internal best practices to ensure

proper analysis and identification risky activities involving third

Monika Rector, CCEP, CIPP, MBA, Health Care Compliance Officer, DePuy Synthes, Companies of Johnson & Johnson

Edward J. Buthusiem, Director, Corporate Compliance & Risk Management Advisory Services, Berkeley Research Group

10:05 Networking and Refreshment Break

Establish Fair Market Value to Enhance Compliance

10:35 Documenting Fair Market Value Compensation for KOLs• Understand the legal basis for establishing

fair market value compensation • Discuss best practices to avoid kickback risks• Learn strategies to overcome implementation

obstaclesColleen M. Roberts, Vice President, Associate General Counsel & Chief Compliance Officer, Fresenius-Kabi

11:15 Are You Paying Fair Market Value?• Discuss approaches to valuing services and

data acquired from physicians and other health care providers

• Analyze pros and cons of using compensation data and other industry benchmarks

• Add more rigor using survey-based approaches• Review case study examplesRick G. Schwartz, Managing Director, Duff & PhelpsDavid Nadell, Vice President, Duff & Phelps

11:55 Networking Luncheon

12:40 Compliance Considerations for the Assessment of FMV in Research Collaborations• Develop a process to ensure that organizational

contribution is proportionate to institutional deliverables (FMV)

• Strategies to properly evaluate potential compliance risks

Nichole White, Compliance Specialist, Siemens Healthcare USA

1:20 FMV — Drill Down Q&A

1:30 Create a Robust Anti-Kickback Audit Program • Remaining safe without a Safe Harbor• The Any One Purpose Rule in the real world• Strategically monitoring HCP data in

the new era of transparency • Review the “Special Fraud Alert” released by

the OIG regarding Physician Owned Entities• Discuss liability as it relates to a c

ontract sales force and distributors• Learn valuable takeaways from recent cases

involving anti-kickback settlements• Investigating a kickback allegation• AKS v. FCPA — Do the risk management tools

really differ?John Knighton, Senior Director, Compliance Operations, Wright Medical Technology

2:10 Close of Conference

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CBI 600 Unicorn Park Drive Woburn, MA 018014 WAYS TO REGISTER NOW!

PHONE800-817-8601 339-298-2100 outside the U.S.

E-MAILcbireg@cbinet.com

WEBSITEwww.cbinet.com/mdcompliance

LIVE CHAT www.cbinet.com/mdcompliance

10th Medical Device and Diagnostics Compliance PC14145

VENUE: Hilton Chicago/Magnificent Mile Suites 198 East Delaware Place

Chicago, IL 60611

Phone Reservations: 800-445-8667

Hotel Direct Line: 312-664-1100

ACCOMMODATIONS: To receive CBI’s special discounted hotel rate online or by phone, please go to:

• Online: www.cbinet.com/mdcompliance• Phone reservations: 800-445-8667 and mention CBI’s Med Device Conference

Book Now! The Hilton Chicago/Magnificent Mile Suites is accepting reservations on a space and rate availability basis. Rooms are limited, so please book early. All travel arrangements subject to availability.

REGISTRATION FEE: ADVANTAGE PRICING Standard Conference $1799 $2099

Register by December 13, 2013 and SAVE $300. Fee includes continental breakfast, lunch, wine and cheese reception, refreshments and conference documentation. Please make checks (in U.S. funds drawn on a U.S. bank) payable to: CBI. (No personal checks accepted.) PLEASE NOTE: All advertised discounts are taken from the final, Standard Rate.

TEAM DISCOUNT:

Attend this conference FREE if you bring 3 registered colleagues from your organization or external to your organization (enables cross-company teams). All team registrations must be made at the same time to qualify. Please contact 800-817-8601 for further information.

SATISFACTION GUARANTEED: CBI stands behind the quality of its conferences. If you are not satisfied with the quality of the conference, a credit will be awarded towards a comparable CBI conference of your choice. Please contact 800-817-8601 for further information. Advanced preparation for CBI conferences is not required.

SUBSTITUTION AND CANCELLATION: Your registration may be transferred to a member of your organization up to 24 hours in advance of the conference. Cancellations received in writing on or before 14 days prior to the start date of the event will be refunded, less a $399 administrative charge. No refunds will be made after this date; however, the registration fee less the $399 administrative charge can be credited to another CBI conference if you register within 30 days from the date of this conference to an alternative CBI conference scheduled within the next six months. In case of conference cancellation, CBI’s liability is limited to refund of the conference registration fee only. CBI reserves the right to alter this program without prior notice. Please Note: Speakers and agenda are subject to change. In the event of a speaker cancellation, every effort to find a suitable replacement will be made without notice. The opinions of the conference faculty do not necessarily reflect those of the companies they represent or CBI.

REGISTER AT WWW.CBINET.COM/MDCOMPLIANCE • 800-817-8601

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Credits Available! Pending Approval

ANY QUESTIONS OR TO REGISTERCALL Christian Alongi 339-298-2131

OR FAX TO MY ATTENTION 781-939-2694 email: christian.alongi@cbinet.com