June 5-6, 2014 Hyatt Boston Harbor Hotel Boston, MA. Sami Yusuf, Strategic Opportunities Management,

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1 The The only INDUSTRY EVENT DEDICATED TO ADDRESSING THE NEEDS OF professionals WHO CONDUCT DUE DILIGENCE Due Diligence Summit For Life Sciences Best Practices to Enhance Portfolio Management, In-Licensing Strategy, and Maximize Profitability of Potential Products, Portfolios, Partnerships and Acquisitions June 5-6, 2014 Hyatt Boston Harbor Hotel Boston, MA Interactive Education Sessions Covering: Portfolio Research & Mergers & Management Development Acquisitions Patent Management & Contract Negotiation Key Take-Aways Include: 2 Karen Gallagher Clinical Due Diligence For New Products, Mergers And Acquisitions, Shire Pharmaceuticals Nic Scalfarotto Director Global Regulatory, Oncology EMD Serono Explore the due diligence process end-to-end through unique case studies and peer-to-peer networking Learn successful project management strategies to control the many moving parts of due diligence Construct 360 degree view of a potential product before licensing in order to minimize risk and maximize profitability Reconcile the need to make a speedy business deal with crucial clinical safety tests and ensure FDA compliance Break out of departmental silos and increase communication to improve workflow Chris Slavinsky Assistant General Counsel, Additional Key Speakers Include: International Keynote Carl Jessop Due Diligence Director, Astrazeneca Bruce Pokras Senior Corporate Counsel, Peggy Berry, Vice President, Head of Quality & Regulatory Affairs, Amarin Sami Yusuf, Strategic Opportunities Management, Upsher-Smith Laboratories Daniel Getts,Director Research & Development, Tolera Therapeutics Eric Waehner, Senior Director, Business Development, Astellas Pharma Natalie Mirutenko, Director Business Development, Takeda Pharmaceuticals International John Li, Head Patents Critical Care & TRD, Pharma Intellectual Property, Novartis Pharmaceuticals Corporation Jing Watnick, PhD MBA, Program & Portfolio Management, Alexion Pharmacueticals Donna M. Meuth, Associate General Counsel, Intellectual Property, Eisai Rick Gregory, PhD, Lab Head, Target Identification & Validation Oncology, Sanofi

2 DEAR COLLEAGUE, As you know, in the pharmaceutical industry competition is fierce. It s not just about having the best product on the market anymore- it s about how much it costs to research and develop that product and how quickly you can get it to market. This means that acquiring and in-licensing has to be an active part of your business development strategy. With this new focus organizations now need to develop effective strategies to assist in understanding which products, drugs and companies they should be focusing on acquiring. With this need, it s now more important than ever to implement and perform effective due diligence. As a key component to measuring the profitability and efficacy of a potential product; it will help to mitigate risks from taking on a new product/portfolio or company as well as ensure regulatory compliance and the negotiation of a mutually beneficial contract. The decentralized nature of the due diligence process has left gaps in a process that needs to be airtight in order to be at it s most efficient. This educational event focuses on how to run a tight ship throughout the due diligence process by presenting you with an experienced speaking faculty that are excited to share their success stories as well as network among their peers. Additionally this inaugural event will explore: Exhaustive pre-due diligence intelligence that must be gathered before preparing to in-license or acquire a target How to design a comprehensive Gap Analysis to order to determine how much more investment and development a product needs What to benchmark against and which metrics are the most successful in assessing the market viability of a target Examine ways to best gain corporate buy-in to the importance of diverting resources to Due Diligence Due Diligence leadership during the long and complicated merger and acquisitions process I look forward to meeting you in Boston this June! Sincerely, Natasia Langfelder Natasia Langfelder Conference Production Director, Due Diligence Summit nlangfelder@exlpharma.com What Your Colleagues are Saying: I m trying to gain greater exposure to BD/licensing and this event seems like a great opportunity to learn more. Associate Director, Merck Due diligence is a great topic this looks like a great conference Director, Amgen A very interesting list of topics not something one sees often. Director Portfolio Integration, Johnson & Johnson The agenda looks great! Associate General Counsel, Eisai Inc. WHO SHOULD ATTEND Professionals in the life sciences industry with responsibilities in the following areas: Due Diligence Licensing Business Development Strategic Alliance/ Alliance Management Portfolio Management Mergers & Acquisitions Scientific Assessment, Corporate Counsel/ Legal This program will also be of interest to Regulatory Compliance Patent Attorney Research & Development Clinical Medicine Clinical Operations Quality Assurance Medical Affairs Lifecycle Management Compliance Regulation Solution Provider Contract Research Organizations (CROs) Contract Manufacturing Organizations (CMOs) Due Diligence Providers Academic Research Facilities Solution Providers Law firms Sponsorship and Exhibit 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 works closely to customize a package that suits all of your needs. To learn more about these opportunities, contact, Andrew Ferguson, Business Development Manager aferguson@exlpharma.com VENUE Hyatt Boston Harbor Hotel 101 Harborside Drive Boston, MA If you require overnight accommodations, please contact the Hyatt Boston Harbor Hotel at to book your room. ExL has reserved a block of rooms at a discounted rate for conference participants. Please mention ExL s Due Diligence to take advantage of this discount. We encourage conference participants to make reservations by May 14th, 2014 as rooms available at this rate are limited.

3 AGENDA Thursday June 5 th, :00 Registration Opens & Continental Breakfast for Workshop Participants 9:00 Pre-Conference Workshop Navigating the Complex Regulatory World of Due Diligence Pre-Conference Workshop Regulatory guidance s play a role in how viable a target is. One has to take into account the regulatory history of the product, the regulatory history of similar products and assess how the product will be treated in today s regulatory environment. Questions such as have the FDA requirements for this product changed? and Is the product in a different therapeutic class? must be answered. This in-depth workshop will cover the extensive network of regulations and FDA considerations one must keep track of during the due diligence process. You will learn: Advice on contractual language, as well as warranties for transactions involving drugs, biologics, and controlled substances How to Evaluate appropriateness and timing of applications to the FDA, DEA, and state and national licensing bodies Effectively plan clinical trials that go beyond FDA standards Strengthen research and plan for GLP/GCP How to provide the best legal protection of intellectual property Darshan Kulkarni, Principal, Kulkarni Law Firm *There will be a 30 minute networking break during this workshop 12:00 Lunch for Workshop Attendees & Main Conference Registration 12:50 Chairperson S Opening Remarks PRC OPERATIONAL GOALS & GOVERNANCE 1:00 Case Study: Lessons Learned in a Realtime Due Diligence Rollout Create new opportunities in product development and avoid pitfalls in the failure to launch trap through innovating past cookie cutter strategies Understand what models of centralization work for your organization Learn the relevant benchmarks to measure success Delve into the regulatory history of a potential product and know what you need to dig for Analyze your findings to understand the next steps you need to take to in order to ensure regulatory compliance Nic Scalfarotto, Director, Global Regulatory Oncology, EMD Serono, Inc. 2:30 Case Study: The Elements Needed to Perform a Comprehensive Gap Analysis The gap analysis is the first step in the Due Diligence process and one of the most crucial What you don t know you don t know about the target can have disastrous results Go through a step-by-step gap analysis to ensure that no stone is unturned Identify red flags early on and know when to cut your losses Karen Gallagher, Clinical Due Diligence For New Products, Mergers And Acquisitions, Shire Pharmaceuticals 3:15 Networking and Refreshment Break 3:45 The Biotech Perspective on Out-Licensing and Preparing for Sale How do you make a product/portfolio as attractive to interested companies as possible? What do you need to do to properly prepare a product for sale and pass a stringent due diligence review? How do you best utilize counsel to get patents in order? Learning from past mistakes- what roadblocks have ended or stalled promising deals and how to avoid this in the future Daniel Getts, Director Research & Development, Tolera Therapeutics 4:30 Panel Discussion: Is the Largest Challenge in Due Diligence a Lack of Opportunities? Business development executives share their scouting techniques What signals a good deal? What should you look for during initial discussions around a potential product? How early should R&D and pre-clinical get involved? What does the business development side of a biotech due to attract a licensing partner? When do you in-license/acquire or partner? Panel Rick Gregory, Ph.D., Lab Head, Target Identification & Validation Oncology, Sanofi US Eric Waehner, Senior Director, Business Development, Astellas Pharma Inc. 5:15 Conclusion of Day One 1:45 When to Recommend a Firewall for Evaluating an In- Licensing Opportunity What departmental functions are most at risk Transparency with the potential partner Who should be above the firewall Documentation Contracting tips Alliance management if the deal goes through Gregory Cox, Assistant General Patent Counsel, Eli Lilly

4 AGENDA Friday June 6 th, :30 Continental Breakfast 12:15 Luncheon 8:30 Chairperson S Recap 8:45 International Spotlight: Case Study of a Successful Merger & Acquisition On July 1st 2013, AZ completed the acquisition of Pearl Therapeutics; Which is now an AstraZeneca Group Company This talk will cover the Due Diligence (DD) process undertaken by AstraZeneca as part of the overall Deal Process It will explore AZ s method of conducting DD as well as the key points and challenges during this particular DD Lessons learned along the way and how to overcome unforeseen stumbling blocks Differences between U.S. and international definitions of Due Diligence Carl Jessop, Due Diligence Director, Astrazeneca 9:30 Accurately Assessing the Patent State of the Product Developing techniques for running a thorough patentability investigation Recognizing the red flags of an indefensible/unprofitable patent Developing a patent that will qualify for Orange Book listing Understanding what you need to file for exclusivity successfully Bruce Pokras, Senior Corporate Counsel, 10:15 Networking and Refreshment Break 10:45 Identify and Develop a Cross-Departmental All-Star Due Diligence Team How is a shortage of skilled labor affecting your Due Diligence team? Prepare beforehand by identifying background profiles of desired team members along with necessary skillsets Energize the team by creating a cohesive unit and incentivizing the process Imbue the target with importance- communicate the market potential to your team to gain their buy-in Natalie Mirutenko, Director Business Development, Takeda Pharmaceuticals International, Inc. 11:30 The In-House Perspective on Leading Due Diligence From the Legal Side Success in deal making may include negotiating favorable terms, drafting effective documents, and launching and selling products but it all begins with understanding and allocating risk-due diligence is the first step in that direction This session discusses risks that typically arise in a pharmaceutical transaction and how early identification of risks in the process allows their proper assignment among the transaction parties Explore the importance of understanding the risk profile of the parties and how that understanding will allow you to build a successful strategy from offer to close Exemplary findings- the possible problems they create and the solutions they require to achieve successful implementation Chris Slavinsky, Assistant General Counsel, 1:15 The Art of Collaboration and Communication Dismantling silos and improving interdepartmental communication Managing teams in the target evaluation process to drive successful pipeline development Bridge the gap between clinical R&D and business development needs Working together to get the deal signed and make it operational Peggy J. Berry, MBA, RAC, Vice President, Head of Quality & Regulatory Affairs, Amarin 2:00 Interactive Discussion: The Working Dynamic Between In-House and Outside Counsel Who is really in charge? How to set the tone and expectations on a project team Best Practices to juggle budgets, timelines, surprises and deliverables Managing expectations through increased and effective communication Proactive thinking and counseling Closure and follow-up INTERACTIVE Donna M. Meuth, Associate General Counsel, Intellectual Property, Eisai Inc. Michael R. McGurk, Outside Counsel to Eisai Inc. 2:45 Case Study: Thinking Outside the Box - Ways to Look to Outside Traditional R&D to find Further Value in a Potential Product An increasingly crowded marketplace means that more drugs are experiencing mediocre sales Avoid falling into the failure to launch trap through innovating past cookie cutter development strategies Go into the pre-clinical phase of due diligence with the mindset of adding value to make this a blockbuster product Looking at clinical development through a commercial lens to enhance market positioning Sami Yusuf, PharmD, Strategic Opportunities Management, Upsher-Smith 3:45 Chairperson Closing Remarks 4:00 Conference Conclusion The topic is valuable and there s a lot to say -Global Project Leader, Takeda I m trying to gain greater exposure to BD/licensing and this event seems like a great opportunity to learn more -Clinical Research, Merck

5 REGISTRATION INFORMATION 5 1 WAYS TO REGISTER mail ExL Events, Inc th Ave, Fourth Floor New York, NY phone fax MEDIA PARTNERS 2 web 5 registration@exlpharma.com REGISTRATION FEES EARLY BIRD PRICING Register by Friday, April 25th, 2014 Your Investment: Conference + Workshop: $2,195 Conference Only: $1,895 STANDARD PRICING Your Investment: Conference + Workshop: $2,395 Conference Only: $2,095 ONSITE PRICING Your Investment: Conference + Workshop: $2,495 Conference Only: $2,195 GROUP DISCOUNT PROGRAMS Offers cannot be combined, early bird rates do not apply. To find out more on how you can take advantage of these group discounts, call Save 25% per person when registering four For every three simultaneous registrations from your company, you will receive a fourth complimentary registration to the program (must register 4 at one time). Save 15% per person when registering three Can only send three? You can still save 15% off of each registration. QUESTIONS? COMMENTS? Do you have a question or comments that you would like to be addressed at this event? Would you like to get involved as a speaker or discussion leader? Please Program Director, Natasia Langfelder at nlangfelder@exlpharma.com PAYMENT Make checks payable to ExL Events, Inc. and write code C517 on your check. You many 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 POLICY If you need to cancel your registration for an upcoming ExL conference, please note the following polices derived from the Start Date of the event: Four weeks or more: A full refund (minus $295 processing fee), or a voucher to another ExL event valid for 18 months from the voucher issue date. Four weeks or less: A voucher to another ExL event valid for 18 months from the voucher issue date. If you cancel at any time after receiving the conference documentation, the voucher will be $395 less. To receive a refund or voucher, please fax your request to or call ExL Pharma 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 Pharma s liability is limited to the conference registration fee in the event of a cancellation and does not include changes in program date, content, speaker or venue. TERMS AND CONDITIONS By registering for an ExL Events, Inc. ( ExL Pharma ) event, you agree to the following set of terms and conditions listed below: Registration Fee: The fee includes the conference, all program materials and designated continental breakfasts, lunches and refreshments. The opinions of this faculty do not necessarily reflect those of the companies they represent or ExL events, Inc. The content in ExL slide presentations, including news, data, advertisements and other information, is provided by ExL Events, Inc. s ( ExL s ) designated speakers and is designed for informational purposes for its attendees, and is NOT INTENDED for purposed of copywriting, not redistribution to other outlets without the express written permission of ExL s designated speaking parties. Neither ExL, nor its content providers and/or speakers and attendees shall be liable for any errors, inaccuracies or delays in content, or for any actions taken in reliance thereon. EXL EVENTS, INC. EXPRESSLY DISCLAIMS ALL WARRANTIES, EXPRESSED OR IMPLIED, AS TO THE ACCURACY OF ANY OF THE CONTENT PROVIDED, OR AS TO THE FITNESS OF THE INFORMATION FOR ANY PURPOSE. Although ExL makes reasonable efforts to obtain reliable content from third parties, ExL does not guarantee the accuracy of or endorse the views or opinions give by any third party content provider. ExL presentations may point to the other Internet sites that may be of interest to you, however ExL does not endorse or take responsibility for the content on such other sites.

6 REGISTER TODAY! mail ExL Events, Inc th Ave, Fourth Floor New York, NY web phone fax Method of Payment: Check Credit Card Make checks payable to ExL Events, Inc. Card Type: MasterCard Visa Discover AMEX Yes! Register me for the conference + workshop! Yes! Register me for the conference only! Please contact me: I'm interested in marketing opportunities at this event I wish to receive updates on ExL Pharma's upcoming events Name: Company: Dept: Address: Title: CONFERENCE CODE: C517 City: State: Zip: Phone: Fax: The The only INDUSTRY EVENT DEDICATED TO ADDRESSING THE NEEDS OF professionals WHO CONDUCT DUE DILIGENCE Due Diligence Summit For Life Sciences Best Practices to Enhance Portfolio Management, In-Licensing Strategy, and Maximize Profitability of Potential Products, Portfolios, Partnerships and Acquisitions June 5-6, 2014 Hyatt Boston Harbor Hotel Boston, MA Interactive Education Sessions Covering: Portfolio Management Research & Development Mergers & Acquisitions Patent Management & Contract Negotiation Karen Gallagher Shire Pharmaceuticals Nic Scalfarotto EMD Serono Chris Slavinsky Bruce Pokras