The 2nd Paragraph IV Litigation Strategy Congress - Momentum Events

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The 2 Paragraph IV Litigation Strategy Congress nd

In-House & Corporate Counsel Attend for as Little as $995

Successful IP Litigation Strategies for Brand and Generic Drug Manufacturers

October 29-30, 2014 • The Hub Cira Centre • Philadelphia, PA Featuring a completely updated speaker faculty for this year, the 2nd Paragraph IV Litigation Strategy Congress focuses on the underlying strategy that can often make or break a Paragraph IV dispute. Explore the most top of mind issues currently impacting pharmaceutical manufacturers on both sides including: • The Top 3 Pre-Suit Due Diligence Issues Counsel on Both Sides Should Be Evaluating In Anticipation of a Paragraph IV Suit • Recent Developments at the Intersection of FDA Regulatory and IP Law and How These Developments are Impacting Approaches to Paragraph IV Disputes • Forfeiture and Multiple Filers: Insights for Avoiding or Triggering Forfeiture Events in Hatch-Waxman Litigation Involving Multiple ANDA Filers • PTO v. Federal Court: Evaluating the Emerging Impact of Parallel PTO Proceedings on the Procedural Dynamics of Hatch Waxman District Litigation Benefit from a Two-Part Focus on Reverse Settlement Payments: SPOTLIGHT ADDRESS: Perspectives from the FTC on Pay-for-Delay Settlements Alpa G. Davis Attorney, Bureau of Competition Health Care Division Federal Trade Commission

Live Mock Negotiation: Paragraph IV Settlements Post-Actavis – Can They Be Done and If So, How?: Witness in real-time the behind-the-scenes discussion that takes place between a brand and generic drug manufacturer, as you observe counsel for each side advance a settlement discussion point by point.

Network with senior in-house IP counsel representing brand name and generic drug manufacturers as well as seasoned jurists who possess firsthand experience in overseeing Paragraph IV disputes: Jenny Papatolis Johnson Senior Patent Attorney Endo Pharmaceuticals Inc. Raymond Parker Executive Director and Assistant General Counsel, Intellectual Property Aptalis Pharma

Brian Hirsch Head, US Patent Litigation Sandoz Inc.

Shahan Islam Senior Corporate Counsel Pfizer Inc

Paul Simboli Vice President and Chief Patent Counsel, Assistant General Counsel Depomed, Inc.

Cynthia H. Zhang Counsel Agilent Technologies, Inc.

Huong Nguyen Senior Director, Intellectual Property Impax Laboratories

Hear directly from the Bench during sessions to address Insider Tips for Obtaining Successful Results When Engaged in a Paragraph IV Dispute in the District of Delaware and How to Most Effectively Present Experts and Witness during Paragraph IV Litigation: Hon. Mary Pat Thynge Chief Magistrate Judge U.S. Dist. Ct., Dist. of DE

founding SPONSOR

Hon. Sherry R. Fallon Magistrate Judge U.S. Dist. Ct., Dist. of DE

lead SPONSORS

Hon. Faith Hochberg District Judge U.S. Dist. Ct., Dist. of NJ

MEDIA PARTNERS

Hon. Garrett E. Brown, Jr. (Ret.) JAMS Former Chief Judge, U.S. Dist. Ct. U.S. Dist. Ct., Dist. of NJ

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WHO YOU WILL MEET Meet the “Who’s Who” of the Hatch Waxman Bar and In-House Practitioners representing brand name, generic and biopharmaceutical manufacturers with responsibility for: • Intellectual property • Patent Litigation • Patent portfolio management • IP licensing • Legal Affairs • Regulatory and Government Affairs • Antitrust

ABOUT THE VENUE The Hub Cira Centre • 2929 Arch Street • Philadelphia, PA

Stash the umbrella: Our Cira Centre facility is attached to Philadelphia’s 30th Street Station, so you won’t even need to brave the elements to get to your meeting. Arrive looking great–and leave feeling like a million bucks, since our Cira Centre is LEED-certified.

Recommended Hotel Accommodations Sheraton Philadelphia University City Hotel • 3549 Chestnut Street • Philadelphia, PA 19104 From museums that trace the history of world civilizations to renowned universities with students from across the globe, to ethnic cuisine and world beat music, Philadelphia symbolizes the melting pot that is America and Sheraton Philadelphia University City hotel is the heart of it all Philadelphia’s Cultural Crossings. All guest room accommodations feature complimentary wireless Internet access and a 37-inch LCD flat screen television. At the Sheraton Philadelphia University City Hotel, out of town doesn’t mean out of touch. You can explore and stay connected to what’s important to you with our Link@ Sheraton experienced with Microsoft in the lobby. In the Link@Sheraton you will receive free access to: Wi-Fi, PC workstations, Printing and TV for lounging. Momentum has secured a rate of $159/night for a single or double room at the Sheraton in connection with your participation at this event. Reservations can be made by calling the hotel reservations line at 888-627-7071 or by accessing this link http://goo.gl/lvwy2t

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To register visit us online at momentumevents.com/pivlitigation


The Paragraph IV Litigation Strategy Congress Looking to hear new perspectives? Tired of attending conferences that address the same topics year after year? Interested in being a part of a forum during which you can sit side by side with in-house counsel representing both brand name and generic drug manufacturers from companies large and small? Benefit from a new kind of conference experience focused on ensuring you derive true value from your time away at the office and at a price you can afford.

125+

EXECUTIVES

including representatives from brand name, generic and biopharmaceutical manufacturers have attended Momentum’s Life Science IP events over the past year alone – here’s just a sample: Executive Vice President, Alvogen • Director, Global Intellectual Property, Amneal Pharmaceuticals LLC • Assistant General Counsel, Aptalis Pharma • Partner, Axinn Veltropp Harkrider LLP • Head, U.S. Specialty Pharmaceuticals & CROs, Barclays Capital • Associate General Counsel, Biogen Idec Inc. • Associate General Counsel for Intellectual Property, Biotechnology Industry Organization • Assistant General Counsel - Patent Litigation, Bristol-Myers Squibb • Senior Director, Legal Services, Caraco Pharmaceuticals • Senior Director, Portfolio Strategy & Licensing, Dr. Reddy’s Laboratories Inc. • Partner, Drinker Biddle & Reath LLP • Associate Senior Counsel IP, Eisai Inc. • CEO, Favus Institutional Research LLC • Senior Staff Attorney, Federal Trade Commission • Partner, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP • Senior Principal, Fish & Richardson • Partner, Fitzpatrick, Cella, Harper & Scinto • Partner, Frommer Lawrence & Haug, LLP • VP, Intellectual Property, Impax Laboratories • VP- Strategic Portfolio Selection & Management, Inno Pharma • Partner, Katten Muchin Rosenman LLP • Head of IP, Micro Labs • Associate Global IP Counsel, Mylan Inc. • VP, IP Counsel and Director, Global Biologics COE, Mylan, Inc. • Vice President, IP Litigation, Novartis Corporation • VP and General Counsel, PDL BioPharma, Inc. • Senior Corporate Counsel, Pfizer Inc. • Lead Patent Counsel, Pfizer Speciality Care • Vice-President and Associate General Counsel, Intellectual Property, Regeneron Pharmaceuticals • Sr. VP, Research and Development, Riconpharma LLC • Partner, Ropes & Gray • Vice President, Investment Team, Royalty Pharma Management, LLC • Chief Patent Counsel, Sanofi Pasteur • Sr. Director, Shire HGT • Vice President and Chief Intellectual Property Counsel, Takeda Pharmaceuticals • VP & General Counsel. Teva Canada Limited • Vice President, Intellectual Property, Valeant Pharmaceuticals • Analyst, Visium

90%+ responsible for IP litigation, strategic patent portfolio management and legal affairs.

Opportunities for best practice sharing and the cross-fertilization of ideas between manufacturers both large and small.

“Attending this conference gives me a chance to get caught up in the various aspects of my field. The speaker panels are highly qualified and very knowledgeable.” - Meg Snowden, VP Intellectual Property Impax Laboratories “One of my favorite things about attending a conference like this is the sharing of different perspectives, from the focus on who the audience is and having the content really focus on what the audience wants.” - Chad Landmon, Partner Axinn Veltropp Harkrider LLP



An important litigation tool that can solidify a patentee’s dominant position in the marketplace or open the flood gates to generic competition, Paragraph IV disputes can offer a great benefit to the 1st ANDA filer while simultaneously posing an incredible risk to the Patentee. Yet, as we continue to see a shrinking number of products commanding billions in revenue and as manufacturers on both sides work to structure settlement agreements that will pass muster in a post-Actavis environment, the 2nd Paragraph IV Litigation Strategy Congress will feature a new focus on key emerging issues that are coming to the forefront in Paragraph IV disputes. In addition to addressing the core topics practitioners are most concerned with including such issues as pre-suit due diligence, the expansion of the Hatch-Waxman safe harbor, the intersection of FDA and IP law, forfeiture and unique litigation issues specific to multiple ANDA filers, attendees of this event will also be provided with content on coming of age issues impacting on the Paragraph IV disputes realm including: • Key Takeaways for Brand Name and Generic Drug Manufacturers from Recent Case Law Examining Section 102, 103 and 112 - Calling into question issues such as indefiniteness, obviousness, enablement, inducement and willful infringement, this session will explore key case law decisions from the past year at both the Federal Circuit and District Court level impacting on Paragraph IV disputes. • PTO v. Federal District Court: Evaluating the Emerging Impact of Parallel PTO Proceedings on the Procedural Dynamics of Hatch Waxman Litigation - Learn how the interjection of these new PTO proceedings are adding yet an other layer of complexity to the already complicated landscape of District Court and Federal Circuit litigation under Paragraph IV. • What Brand Name and Generic Drug Manufacturers Can Learn from Recent Third Party Payor Suits Challenging the Implications of Hatch Waxman Litigation on Drug Competition - As the antitrust implications of Paragraph IV litigation continue to play out in light of Actavis, this session will engage attendees in an examination of the legal exposure brand companies are increasingly facing by way of private class action litigation. Benefit from a special address by the Hon. Paul R. Michel, Former Chief Judge, U.S. Court of Appeals for the Federal Circuit on Patent Reform - What You Don’t Know is In There: A True Examination of Proposed Patent Legislation and the Impact That Each Bill Could Have on the Pharmaceutical Industry and Related IP Litigation. Moved this year to Philadelphia at a venue conveniently located at the 30th Street Train Station to provide easy access to transportation in and out of the city to New Jersey and New York as well as the Philadelphia Int’l Airport, the 2nd Paragraph IV Litigation Strategy Congress offers the following unique benefits to attendees: • Priced at less than ½ the registration fee charged for other events on the same subject • A full, two-day conference experience that addresses all of the key top of mind issues for practitioners in the space, complete with Judges panels, spotlight sessions and panel discussions • An interactive LIVE mock negotiation on How to Structure A Legally-Compliant Paragraph IV Settlement that passes muster in a post-Actavis environment • 2 working group sessions that deliver specially-focused content for brand name and generic drug manufacturers • Unlimited complimentary access to post-event, subject matter specific webinars • Advanced access to your fellow attendees through MomentumConnect which allows you to request and setup meetings in advance of the event

Included in the Cost of Registration, Brand Name and Generic-Specific Working Group Sessions: For Brand-Name Manufacturers: Strategy Discussion PTEs, Combination Products and “Product Hopping” Life Cycle Management Insights for Brand Name Drug Manufacturers Engaged in Paragraph IV Litigation During this session engage in a discussion of real-life case examples which explore how brand name drug manufacturers have strategically approached the management of their company’s patent portfolio in anticipation of and during the pendency of a Paragraph IV dispute.

For Generic Manufacturers: Interactive Mock Session At Risk Launches - An Examination of the Business Benefits and Legal Risks of Launching at Risk – How to Determine If It’s Truly Worth It…or Not Uniquely set as a mock examination of a real-life scenario, hear from senior in-house counsel representing generic drug manufacturers and the attorneys who represent them as they engage you in a discussion of the true legal risks and potential business benefits of making the decision to launch “at risk.”

Don’t miss the only PIV litigation event that provides you with behind the scenes insights into the issues that in-house counsel consider and weigh in the balance before, during and after a Paragraph IV dispute has concluded.

To register, visit the website at momentumevents.com/pivlitigation


MAIN CONFERENCE AGENDA

Day One – WEDNESDAY, OCTOBER 29, 2014 8:00am

Registration & Breakfast

8:45am

Chair’S Opening Remarks

Bradford P. Lyerla Partner Jenner & Block

Brian Hirsch Head, US Patent Litigation Sandoz Inc.

Shahan Islam Senior Corporate Counsel Pfizer Inc.

9:00am Key Takeaways for Brand and Generic Drug Manufacturers from Recent Case Law As the face of competition within the pharmaceutical industry continues to evolve with generic drug manufacturers competing more heavily for market share of the few blockbuster drugs that remain on market, this year was witness to some very impacting developments in life sciences IP case law. Calling into question such issues as indefiniteness, obviousness, enablement, inducement and willful infringement, this session will explore key case law decisions from the past year at both the Federal Circuit and District Court level involving Paragraph IV disputes. Raymond Parker Executive Director and Assistant General Counsel, Intellectual Property Aptalis Pharma

Hon. Arthur J. Gajarsa (Ret.) Senior Counsel, Wilmer Cutler Pickering Hale and Dorr LLP Former Circuit Judge, U.S. Court of Appeals for the Federal Circuit

Sherry M. Knowles Knowles Intellectual Property Strategies

Moderator: Brian Sodikoff Partner Katten Muchin Rosenman LLP

10:15am Are Your Ducks in a Row? Examining the Top 3 Pre-Suit Due Diligence Issues Counsel on Both Sides Should Be Evaluating In Anticipation of a Paragraph IV Suit Making the decision to certify Paragraph IV as an ANDA filer sets into motion a series of timed events that cannot be retracted once triggered. Similarly as a patentee whose underlying IP rights are coming under attack, one cannot underestimate the value of advanced preparation and having your “house in order” once notice is received. During this session hear from a diverse panel representing seasoned IP counsel for both brand name and generic drug manufacturers as you are engaged in a discussion that steps beyond the basics of pre-suit due diligence to explore key advanced strategy considerations that should be at the top of your Paragraph IV due diligence checklist in the following three areas – • Timing and jurisdictional questions – when and where – an examination of recent cases that demonstrate why these considerations are an all important factor • Theories of infringement and defenses – what’s working, what’s not and an examination of new and emerging theories – obviousness-type double patenting, anticipation, doctrine of equivalents, induced infringement, enablement, written description • Patent assertion – deciphering which patents to assert, not assert or list – understanding the downstream repercussions of each decision Jenny Papatolis Johnson Senior Patent Attorney Endo Pharmaceuticals Inc.

11:00am

Aaron F. Barkoff Shareholder McAndrews, Held & Malloy

Paul Simboli Vice President and Chief Patent Counsel Assistant General Counsel Depomed, Inc

Morning Refreshment Break

“One of the wonderful things about coming to this conference is that I can network with colleagues and clients and meet up with them in a very social arena, catch up with them and listen to current topics.” - Mercedes Meyer, Partner, Drinker Biddle & Reath To register visit us online at momentumevents.com/pivlitigation


MAIN CONFERENCE AGENDA (continued) 11:30am The Expansion of the Hatch Waxman Safe Harbor: Addressing HOW Recent Developments in the Evolution of Case Law Are Impacting Litigation Approaches to Paragraph IV Disputes Under the Hatch Waxman scheme, FDA regulatory and IP law are so intertwined that they almost become inseparable as distinguishable issues. During this session be brought up to speed on recent trends and developments in the continued expansion of the Hatch Waxman Safe Harbor as you are provided with insights into how companies on both sides are adjusting their litigation strategies to account for this new evolution in the interpretation of the statute. Cynthia H. Zhang Counsel Agilent Technologies, Inc.

Brian Coggio Senior Principal Fish & Richardson P.C.

12:30pm

Networking Luncheon

1:30pm

PTO v. Federal District Court: Evaluating the Emerging Impact of Parallel PTO Proceedings on the Procedural Dynamics of Hatch Waxman Litigation

As the newly established and updated USPTO procedures for re-evaluating and challenging patents begin to take hold, brand name and generic drug manufacturers are taking their claims to the Patent Trial and Appeals Board seeking a second look at their most hotly contested IP rights. Often running parallel to ongoing Paragraph IV litigation, it seems this new wave of companion administrative proceedings are having a significant impact on the overall procedural dynamic of the Hatch Waxman litigation scheme, particularly with respect to the forfeiture of exclusivity. During this session, learn how the interjection of these new PTO proceedings are adding yet another layer of complexity to the already complicated landscape of District Court and Federal Circuit litigation under Paragraph IV. Craig M. Kuchii Partner Katten Muchin Rosenman LLP

2:30pm

Huong Nguyen Senior Director, Intellectual Property Impax Laboratories

Patent Reform - What You Don’t Know is In There: A True Examination of Proposed Patent Legislation and the Impact Each Bill Could Have on the Pharmaceutical Industry and Related IP Litigation

Over the past year there has been a great deal of legislation proposed on the Hill to address everything from patent trolls to patent litigation abuse and everything in between. During this session be brought up to speed on the current status of proposed and pending bills specifically targeting patent and IP issues as you are provided with specific commentary on how each of the below could impact IP litigation within the pharmaceutical industry. Legislation to be addressed during this session will include: • Innovation Act (H.R. 3309) • Patent Abuse Reduction Act of 2013 (S. 1013) • Patent Litigation Integrity Act of 2013 (S. 1612) • Patent Litigation and Innovation Act of 2013 (H.R. 2639) • Patent Transparency and Improvements Act of 2013 (S. 1720) *Please note that the legislation to be addressed during this session will be updated to address all pertinent bills as of the date of this event. Hon. Paul R. Michel (Ret.) Former Chief Judge U.S. Court of Appeals for the Federal Circuit

Shahan Islam Senior Corporate Counsel Pfizer Inc.

3:15pm Afternoon Refreshment Break

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MAIN CONFERENCE AGENDA (continued) 3:45pm

Insider Tips for Obtaining Successful Results When Engaged in a Paragraph IV Dispute in the District of Delaware: Proven Strategies for Effectively Engaging with the Bench and Working with Local Counsel

One of the hottest venues for complex, high stakes IP disputes, particularly Paragraph IV disputes, the role of local counsel when engaged in litigation in the District of Delaware is not one that can be underestimated or taken lightly. Although there are no local patent rules that apply to IP disputes brought in the District, it is common knowledge that there are certain unique procedures and guidelines the Bench requires adherence to. During this insightful session hear directly from a panel including the Delaware district court bench, as well as local counsel experienced in navigating the nuances presented by Paragraph IV disputes brought in Delaware as the following topics are addressed: • How to best select and effectively work with local counsel in Paragraph IV disputes • Understanding specific guidelines, procedural requirements and expectations of the Delaware bench in complex Paragraph IV disputes – summary judgment, Markman hearings • Weighing the pros and cons of electing to have local counsel vs. lead counsel argue key motions • How to balance the role of local counsel with lead counsel on key trial and strategy issues • Best practices for effective case management when working with local counsel Hon. Mary Pat Thynge Chief Magistrate Judge U.S. District Court District of Delaware

Hon. Sherry R. Fallon Magistrate Judge U.S. District Court District of Delaware

Steven J. Balick Chair, Intellectual Property Group Ashby & Geddes, P.A.

5:00pm Conference Adjourns to Day Two

Day Two – THURSDAY, OCTOBER 30, 2014 8:00am

Breakfast

8:45am

Chair’s Recap from Day one

9:00am

Insider Tips from the Bench on How to Most Effectively Present Experts and Witness during Paragraph IV Litigation

During this session hear from a renowned panel of jurists as they share their insights on such critical litigation issues as experts, witnesses, settlement and mediation, particularly within the context of Paragraph IV disputes. Learn what judges like and dislike by way of expert testimony and cross examination as you are provided with winning strategies for successfully positioning your case. Please come prepared with your most pressing questions to pose to this distinguished panel at the conclusion of the session. Hon. Faith Hochberg District Judge U.S. Dist. Ct., Dist. of NJ

10:00am

Hon. Garrett E. Brown, Jr. (Ret.) JAMS Former Chief Judge, U.S. Dist. Ct. U.S. Dist. Ct., Dist. of NJ

Moderator: Sara Tonnies Horton Partner Jenner & Block

Forfeiture and Multiple Filers: Avoiding or Triggering Forfeiture Events in Hatch-Waxman Litigation Involving Multiple ANDA Filers

• Strategies for preserving your position and obtaining the desired result when multiple ANDA filers are involved • Dissecting triggering circumstances for the forfeiture provisions and the impact on litigation of later filers • Addressing relinquishment and waiver • Patent delisting and forfeiture – where the two roads intersect Stephen P. Benson Partner Katten Muchin Rosenman LLP



MAIN CONFERENCE AGENDA (continued) 10:45am

Morning Refreshment Break

Focus on Reverse Settlement Payments 11:15am

Spotlight Address: Perspectives from the FTC on Pay-for-Delay Settlements

Alpa G. Davis Attorney, Bureau of Competition, Health Care Division Federal Trade Commission

12:00pm

Networking Luncheon

1:15pm Live Mock Negotiation: Paragraph IV Settlements Post-Actavis – Can They Be Done and If So, How? A new twist on the traditional Paragraph IV settlement discussion, during this engaging live mock negotiation attendees will witness the behind-the-scenes discussion that take places between a brand and generic drug manufacturer, but now re-positioned in light of Actavis and its progeny. Witness counsel for each side as the discussion advances point by point as the moderator highlights key aspects of the proposed agreement that in a post-Actavis world will no longer pass regulatory muster. Learn how Paragraph IV settlements will now be scrutinized with an eye towards understanding what elements need to be present in your agreement in order to ensure no signs of anticompetitive behavior are present. Moderator: Aaron A. Barlow Partner Jenner & Block

2:15pm Communication with Key Stakeholders: Litigation Communication Strategies for In-House Counsel When Actively Engaged in a Paragraph IV Dispute During this session hear from senior patent counsel with firsthand experience in high stakes Paragraph IV litigation as they share and discuss approaches for effectively communicating with senior level management and key stakeholders during the pendency of litigation. Learn how to navigate delicate considerations surrounding protective orders that may be issued during the pendency of a case as well as insights for walking the fine line between sharing too much information and just enough without opening the door for more exposure by way of senior executive statements to stockholders and board members. Charlotte Jacobsen Partner Fitzpatrick, Cella, Harper & Scinto

2:45pm When Prior Settlements Come Back To Haunt You: What Brand Name and Generic Drug Manufacturers Can Learn from Recent Third Party Payor Suits Challenging the Implications of Hatch Waxman Litigation on Drug Competition As the antitrust implications of Paragraph IV litigation continue to play out in light of the Supreme Court’s 2013 decision in FTC v. Actavis, this session will engage attendees in an examination of the legal exposure brand companies are increasingly facing by way of private class action litigation. Learn what theories that have been most successful in alleging “sham” patent litigation claims as the session leaders examine the intersection of antitrust class action claims and Paragraph IV litigation.board members. Brent W. Landau Partner Hausfeld LLP

In Conversation With: Nicholas A. Widnell Counsel Boies, Schiller & Flexner LLP



MAIN CONFERENCE AGENDA (continued)

for brand name manufacturers

3:30pm Afternoon Refreshment Break 3:45pm

Interactive Working Group Sessions

Interactive Strategy Discussion: PTEs, Combination Products and “Product Hopping”: Life Cycle Management Insights for Brand Name Drug Manufacturers Engaged in Paragraph IV Litigation Life cycle management is a priority for brand name drug manufacturers 365 days of the year. Yet, once the Paragraph IV dispute mechanism is triggered by an ANDA filer, the strength of one’s patent portfolio takes center stage as an issue of utmost concern. Now faced with challenges of products differing in value from the billions to the tens of millions, gone are the days of Paragraph IV certifications brought only against the most highly valued, blockbuster patents - in today’s market no challenge is off the table. Specifically structured to provide a closed door forum for brand name drug manufacturers to discuss and strategize approaches for effectively managing one’s patent portfolio once a Paragraph IV action has been commenced, during this session the panel leaders will address recent trends in brand name manufacturer portfolio management. During this session learn how brand name drug companies are – • Selecting which patents to submit for reexamination or reviews • Shoring up patents not subject to a Paragraph IV dispute when in the midst of Paragraph IV litigation • Balancing the demands of patent prosecution with simultaneous litigation • Dealing with Orange Book patents in the midst of an active Paragraph IV case

for generic manufacturers

Time will be dedicated during this session to addressing real-life case examples in which brand name companies have tried various approaches to varying degrees of success. Be engaged in a discussion of these cases as you are guided through a step-by-step examination of what the behind-the-scenes strategy was, what the thinking was behind each approach and how the results of each case may or may not have been worth the risk incurred.

Interactive Mock Session - At Risk Launches: An Examination of the Business Benefits and Legal Risks of Launching at Risk – How to Determine If It’s Truly Worth It…or Not Making the decision to launch a product “at risk” is one that can bring with it great financial benefit on the one hand, but equally high damages on the other. If the launch is a success the profit made as the first generic manufacturer to enter the market can mean a substantial financial windfall. On the other hand, if in the interim a decision is handed down by the district court on the issue of patent validity, the damages sought by the brand name manufacturer could easily trump any profits from the “at risk” launch. During this engaging working group session, set as a mock examination of a real-life scenario, hear from senior in-house counsel representing generic drug manufacturers and the attorneys who represent them as they engage you in a discussion of the true legal risks and potential business benefits of making the decision to launch “at risk.” Topics to be addressed during this session will include: • Timing – examining when the circumstances are most ripe/less ripe to launch “at risk” • Examining the impact of a CAFC appeal on the decision to launch at risk • Addressing when a stipulated injunction may make the most sense • Discussing authorized generics and how they may impact an “at risk” launch • Damages – calculating potential damages in the context of an “at risk” launch – is it worth it? Huong Nguyen Senior Director, Intellectual Property Impax Laboratories

5:15pm Conference Concludes



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Register online at momentumevents.com/pivlitigation, email [email protected] or call +1 646.807.8555. Group Bookings Group discounts are available for 2 or more attendees. Register 2 or more attendees and receive a 10% discount on all bookings. Register 3 or more attendees for bigger savings. This discount may not be combined with any other offer. All attendees must be employed by the same organization and must register together in one transaction. One invoice will be issued to the group lead. ATTENDEE FEE Includes conference and all working group discussion, round tables, momentum connect and post-event webinars (all prices usd). ATTENDEE

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$1195

$1395

Terms and Conditions • Registration fees may not be shared among people from the same firm or company. • Payment must be received in full by the conference date. • Any early registration or other discounts cannot be combined and must be applied at the time of registration. • Group discounts are available to individuals employed by the same organization. If you are unable to attend the conference, you may designate a substitute. Substitution, cancellation and refund requests must be made via e-mail to [email protected] in accordance with the information found online at: http://momentumevents.com/attendee-information. There are no refunds for no-shows. For more information regarding administrative policies such as complaint and refund, please contact our offices at 914.293.0350. All requests for refunds or changes to your hotel room reservation must be made directly with the hotel. Photos and Video Event registration implies your consent that any pictures and/or video obtained during the event may be used for future promotional purposes. Momentum is able to use your likeness without remuneration.

BOOKING FORM For faster and more accurate service, please register online at momentumevents.com/pivlitigation Online registrants may pay by credit card, wire transfer, check or request an invoice. You may also use this form and mail it with payment to: Momentum Suite 100, 50 Dimond Avenue, Cortlandt Manor, NY 10567, USA o yes, Please register the following attendees for The 2nd Paragraph IV Litigation Congress Contact Details Name______________________________________________________ Position___________________________________________ Approving Manager___________________________________________ Position___________________________________________ Organization___________________________________________________________________________________________________ Address_______________________________________________________________________________________________________ City__________________________________State__________________ ZIP Code_______ Phone_____________________________ Fax___________________________________E-mail_________________ Type of Business____________________________________ Please charge my: o VISA o MasterCard o AMEX o Discover o Please invoice me Card Number______________________________________________________________________________ Exp. Date_______________ Signature___________________________________________________ F O R C R E D I T C A R D A U T H O R I Z AT I O N

o I HAVE ENCLOSED MY CHECK FOR $_________MADE PAYABLE TO MOMENTUM EVENT GROUP. o ACH PAYMENT Please quote the name of the attendee(s) and the EVENT code 143W14-PHI as a reference. Please e-mail [email protected] to receive Wire Transfer and ACH details. W9: If you require a W9, please download it directly from www.momentumevents.com/w9

To register visit us online at event group

www.momentumevents.com/pivlitigation