Reporting and Compliance Strategies to Drive Aggregate Spend Efficiency SPOTLIGHT FACULTY MEMBERS

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1 6 TH JUNE 8-9, 2015 SONESTA HOTEL PHILADELPHIA, PA AGGREGATE SPEND AND SUNSHINE ACT CONFERENCE Enhance Data Disclosure, Transparency Reporting and Compliance Strategies to Drive Aggregate Spend Efficiency SPOTLIGHT FACULTY MEMBERS MICHAEL HUNN Quality Project Manager, Compliance DRAEGER MEDICAL EREN EFE Manager, General Accounting and Transparency Reporting CAREFUSION HEATHER MCCOLLUM, J.D., MHA Director, Compliance SHIONOGI INC. CORE AGGREGATE SPEND AREAS TO BE ADDRESSED DISCLOSURE ISSUES DANA SZE Director, HCP Payment Disclosure PFIZER DISPUTE RESOLUTION METHODOLOGIES REPORTING PROTOCOLS TRANSPARENCY ENHANCEMENTS SUBMISSION TECHNIQUES CONFERENCE CHAIRMAN: ABE WELLE Senior Compliance Program Manager MEDTRONIC JENNIFER MCGEE Senior Compliance Counsel OTSUKA LEARNING OBJECTIVES 1. Cultivate discussion surrounding the Validated Physician List provided by CMS 2. Design notification strategies for health care professionals to ensure reportable payments are received 3. Build protocols behind falsification expense reports and outline pipeline obligations surrounding information correction 4. Optimize reporting exceptions and isolate daily protocols for payment collections 5. Incorporate flexibility into system protocols in order to efficiently cope with CMS rule changes ExL Events certifies that this conference has been approved for 10.5 Continuing Education Credits (CEU) by the Compliance Certification Board (CCB).

2 Dear Colleague, When any type of payment is offered to a physician from a life science company, documentation of this needs to be available to the general public. This, in turn, requires compliance from companies who are offering gifts and payments to these physicians. With rules explicitly outlined in the Physician Payments Sunshine Act, reporting to the Department of Health and Human Services is mandatory, and failure to do so can bring severe consequences. Advisory board involvement may be crucial, but that is not the only way to get around these reporting penalties. The 6th Aggregate Spend and Sunshine Act Conference, June 8-9, 2015 in Philadelphia, PA, will provide the audience with the tools to operate in the most transparent manner possible and ensure that no falsifications occur on their organizations behalf. This conference will bring together executives from pharmaceutical, biotechnology and medical device companies to examine case studies and challenges surrounding transparency reporting. With a focus on disclosure issues, dispute resolution methodologies, reporting protocol and transparency enhancements, this meeting is not to be missed. Together, we will overcome the obstacles causing the biggest frustrations and come up with a universal solution. Join us at the 6th Aggregate Spend and Sunshine Act Conference to hear from top industry thought leaders and have the chance to learn from the best. This event is sure to deliver countless benefits through plenary and keynote sessions, panel discussions, and interactive talks. As the aggregate spend industry space is ever changing and requirement updates from the Center for Medicare and Medicaid Services occur frequently, your organization cannot afford to skip out on this event. A large majority of sunshine and compliance professionals are facing the same obstacles that you are, and together we can alleviate this stress. WHO SHOULD ATTEND This conference is designed for representatives from pharmaceutical, biotechnology and medical device companies with responsibilities in the following areas: Aggregate Spend Corporate/Regulatory/Risk Compliance and Ethics State Reporting/Transparency Spend Reporting Transparency Business Analysis and Development Finance and Accounting Legal and Regulatory Affairs Government Affairs Sales and Marketing Commercial Operations Clinical Operations IT/IS Medical Affairs Contract Administrators Internal and External Training We look forward to welcoming you to Philadelphia this June! Sincerely, Brendan Weiss Brendan Weiss Conference Production Director ExL Events This conference is also of interest to: Sunshine Reporting Technology Vendors Legal Teams Consultants CROs VENUE INFORMATION Sonesta Hotel Philadelphia 1800 Market St. Philadelphia, PA The new Sonesta Philadelphia Downtown offers a spectacular downtown location convenient to whatever brings you to the City of Brotherly Love. Located near world-class restaurants and boutique shopping at ritzy Rittenhouse Square in Center City, the hotel is within the business district and walking distance to many popular Philadelphia attractions, historic landmarks, museums and theatres. To make reservations guests can call SONESTA ( ) and request the negotiated rate for ExL s June Meetings. The group rate is available until Monday, May 18, Please book your room early as rooms available at this rate are limited.

3 DAY ONE AGENDA JUNE 8, :00 Registration Opens and Continental Breakfast 9:00 Chairperson s Opening Remarks 9:15 CASE STUDY Protocol Enhancements in Sunshine Act Filing for the Evolving Industry Utilizing process flexibility to comply with complex CMS requirements Creating new platform efficiencies to streamline Sunshine reporting efforts Harnessing the importance of data collection, reporting and integrity Danielle Bacco, Senior Manager, Corporate Compliance, PURDUE PHARMA Michael Grandison, Analyst, Corporate Compliance, PURDUE PHARMA 10:00 Adapt Aggregate Spend Process Improvements for Successful Involvement in the Transparency Reporting Realm Sharing enhanced approaches behind coping with constant industry software changes Uncovering implementation techniques for removed and rejected record systems Dealing with CMS rejection files and understanding proper protocols behind altering internal records for CMS discrepancies Michael Hunn, Quality Project Manager, Compliance, DRAEGER MEDICAL 10:45 Networking and Refreshment Break 11:15 Preparation for Potential Mergers and Acquisition Reporting with CMS Reviewing CMS guidance for open payment reporting of acquisitions Identifying aggregate spend considerations during due diligence and post-close integration Discussing challenges related to acquisition reporting and leveraging solutions to overcome them 1:15 PANEL DISCUSSION Generate Solutions to Limit Operational Hindrances in Dispute Resolutions Optimizing preparation practices for dispute resolution with physicians and health care professionals Directing focus to proactive notification and dispute resolution workflows Uncovering strategies behind complying with complex dispute resolution requirements Jennifer McGee, Senior Compliance Council, OTSUKA Heather McCollum, J.D., MHA, Director, Compliance, SHIONOGI INC. 2:00 The Impact of Disclosure Regulations on Clinical Research Highlighting the importance of industry relations with physicians and academia Addressing research sponsors reporting obligations under the Sunshine Act Communicating potential challenges with reporting research and transparency reporting Dana Sze, Director, HCP Payment Disclosure, PFIZER 2:45 Networking and Refreshment Break 3:15 INTERACTIVE SESSION Uncover Lessons Learned During the First Two-Year Filings Designing advanced notification strategies for covered recipients for data that will be reported Identifying discrepancies and exceptions in aggregate spend reports and covered receipt data Analyzing common data submission and data correction challenges and harnessing solutions Eren Efe, General Accounting and Transparency Reporting, CAREFUSION 4:00 Implement Strategies for Data Review and Remediation Enhancing format, frequency and analytical techniques for data review and auditory purposes Identifying outliers and addressing cases of potential falsification Using data analytics and dashboards to improve data quality and reduce error likelihood Heather McCollum, J.D., MHA, Director, Compliance, SHIONOGI INC. 12:00 Luncheon Interesting perspectives, engaging speakers. Director, Transparency Spend Reporting, GSK 4:45 Conclusion of Day One

4 DAY TWO AGENDA JUNE 9, :00 Continental Breakfast 12:00 Luncheon 9:00 Chairperson s Recap of Day One 9:15 Explore Discrepancies and Challenges Due to the Recently Completed March Data Submission Learning how to utilize published CMS industry data and understand what the CMS is actually seeking Analyzing organization databases to facilitate relationships between the industry and health care professionals Building systems for next year to overcome common obstacles surrounding this submission Sergio Alegre, Senior Director, Compliance, PACIRA PHARMACEUTICALS 10:00 Resolve Issues Surrounding Assumption Documents to Avoid Discrepancy Understanding preliminary steps before entering into a correction audit Laying the groundwork for assumption documentation to ensure efficacy Communicating documentation strategies and systems across the industry to decrease discrepancies 10:45 Networking and Refreshment Break 11:15 Optimize Transparency Reporting Protocols with Distribution, Grant Approval and Global Business Policies Leveraging differences in health care professional relationships between American Federal and European Union requirements Understanding complexities in global and domestic HCP definitions and reporting suggestions Maximizing approval trends and record distribution in order to avoid fraud Toni Brock, Director, Business Projects and Planning, BRISTOL-MYERS SQUIBB 1:15 PANEL DISCUSSION Apply Enhanced Methodologies to Internally Align Complex State Transparency Requirements Harnessing approaches to overcome challenges such as multiple deadlines, vague definitions and undisclosed systems Generating a list of resources to meet state requirements put forth by the CMS Resolving internal discrepancies with the help of financial and technology representatives to alleviate these worries Donna White, Senior Director, Contracts and Compliance, CHIESI USA Dana Sze, Director, HCP Payment Disclosure, PFIZER 2:00 Improve Reporting Compliance Through Fundamental Modification and Specific Attention to Requirements Ensuring reporting requirements are addressed in thirdparty agreements prior to signage Reviewing existing agreements for fair market value and necessary data fields to guarantee satisfaction of reporting requirements Cultivating relationships with key stakeholders to improve future reporting Donna White, Senior Director, Contracts and Compliance, CHIESI USA 2:45 Chairperson s Closing Remarks 3:15 Conference Concludes Great questions answered! Transparency Operations, SANOFI Very knowledgeable speakers! Senior Manager, ASTRAZENECA Good discussions with methodologies. Director, DRAEGER MEDICAL SYSTEMS

5 MEDIA PARTNERS Sponsorship and Exhibiting Opportunities Do you want to spread the word about your organization s solutions and services to potential clients who attend this event? Take advantage of the opportunity to exhibit, present an educational session, host a networking event or distribute promotional items to attendees. ExL Pharma works closely with you to customize a package that suits all of your needs. To learn more about these opportunities, contact Matthew Halverson, Business Development Manager, at or mhalverson@exlevents.com. WAYS TO REGISTER PRICING EARLY BIRD PRICING* Register before May 1, 2015 Conference $1,895 STANDARD PRICING* Register after May 1, 2015 Conference $2,095 ONSITE PRICING* registration@exlevents.com Conference $2, ExL Events, Inc th Avenue, Fourth Floor New York, NY GROUP DISCOUNT PROGRAMS *Offers may not be combined. Early Bird rates do not apply.* SAVE 25% For every three simultaneous registrations from your company, you will receive a fourth complimentary registration to the program (must register four). A savings of 25% per person. SAVE 15% Can only send three? You can still save 15% off of every registration. To find out more on how you can take advantage of these group discounts, please call *Includes Sales Tax and Service Fees Questions? Comments? Do you have a question or comment that you would like to be addressed at this event? Would you like to get involved as a speaker or discussion leader? Please Conference Production Director Brendan Weiss at bweiss@exlevents.com. Payment Make checks payable to ExL Events, Inc. and write code C616 on your check. You may also use Visa, MasterCard, Discover or American Express. Payments must be received in full by the conference date. Any discount applied cannot be combined with any other offer and must be paid in full at the time of order. Parties must be employed by the same organization and register simultaneously to realize group discount pricing options. **Please Note: There will be an administrative charge of $300 to substitute, exchange and/ or replace attendance badges with a colleague occurring within five business days of any ExL conference.** Cancellation and Refund Policy If you need to cancel your registration for an upcoming ExL event, please note the following policies derived from the Start Date of the event: Four weeks or more: A full refund (minus a $295 processing fee) or a voucher to another ExL event valid for 12 months from the voucher issue date. Less than four weeks: A voucher to another ExL event valid for 12 months from the voucher issue date. If you cancel at any time after receiving the conference documentation, the voucher issued will be $395 less. To receive a refund or voucher, please fax your request to Credit Vouchers Credit Vouchers are valid for 12 months from date of issue. Credit Vouchers are valid toward one (1) ExL Event of equal or lesser value. If the full amount of said voucher is not used at time of registration, any remaining balance is no longer applicable now or in the future. Once a Credit Voucher has been applied toward a future event, changes cannot be made. In the event of cancellation on the attendees behalf, the Credit Voucher will no longer be valid. Substitution Charges There will be an administrative charge of $300 to substitute, exchange and/or replace attendee badges with a colleague occurring within five business days of the conference. ExL Events reserves the right to cancel any conference it deems necessary and will not be responsible for airfare hotel or any other costs incurred by registrants. ExL Events liability is limited to the conference registration fee in the event of a cancellation and does not include changes in program date content speakers or venue. * The opinions of ExL speakers do not necessarily reflect those of the companies they represent or ExL Events, Inc. Please Note: Speakers and agenda are subject to change without notice. In the event of a speaker cancellation, significant effort to find a suitable replacement will be made.

6 5 Ways to Register Yes! Register me for the conference! Name: Company: Dept.: Address: ExL Events, Inc th Avenue, Fourth Floor New York, NY Title: Method of Payment: Check Credit Card Make checks payable to ExL Events, Inc. Card Type: MasterCard Visa Discover AMEX Card Number: Exp. Date: Name on Card: Signature: Please contact me: I'm interested in marketing opportunities at this event I wish to receive updates on ExL Pharma's upcoming events City: State: Zip: CONFERENCE CODE: C616 Phone: Fax: 6 TH AGGREGATE SPEND AND SUNSHINE ACT CONFERENCE Enhance Data Disclosure, Transparency Reporting and Compliance Strategies to Drive Aggregate Spend Efficiency CORE AGGREGATE SPEND AREAS TO BE ADDRESSED DISCLOSURE ISSUES DISPUTE RESOLUTION METHODOLOGIES REPORTING PROTOCOLS TRANSPARENCY ENHANCEMENTS SUBMISSION TECHNIQUES JUNE 8-9, 2015 SONESTA HOTEL PHILADELPHIA, PA CONFERENCE CHAIRMAN: ABE WELLE Senior Compliance Program Manager MEDTRONIC