Register by January 28, 2011 and Receive $300 Off of Your Registration Fee! r e di t s C B I ’ s 6 t h S u m m i t o n CLE Cilable Biosimilars and Av a l prova g Ap Pendin Follow-On Biologics Leverage the Regulatory, Legal and Clinical Realities of the Biologics Price Competition and Innovation Act to Achieve Maximum Commercial Value March 30-31, 2011 • The Westin Tysons Corner • Falls Church, VA Conference Co-Chairs: Progr a m Highlights Bruce A. Leicher, Senior Vice President The FTC speaks to mergers, acquisitions and patent and General Counsel, licensing issues surrounding FOBs Momenta Pharmaceuticals, Inc. Michael Castagna, Examine the next major controversy regarding Executive Director, Orencia, biosimilars — Nomenclature and implications for Bristol-Myers Squibb; Former Vice President, Sales and U.S. marketing efforts Marketing Biopharmaceuticals, Sandoz Inc. Weigh the effort of developing differentiated biosimilars Elite Faculty against the potential payoff of gaining incremental market Perspectives from: share in world markets • Walgreens Specialty Pharmacy Discuss synergies in managing both biosimilar and brand • Accredo Health Group product portfolios within one company • Harriman Biopartners, LLC • Federal Trade Commission • Genentech — PLUS! A member of the Roche Group • Glenmark Pharmaceuticals Choose from Two Pre-Conference Workshops on Wednesday, March 30, 2011: • Takeda • Widener University A: Explore the Reimbursement Landscape for Biosimilars and its Impact on • Biotechnology Information Institute Distribution Systems • Harvest Moon Pharmaceuticals USA, Inc. B: Keys for Commercial Success in • Stoel Rives LLP Ex-U.S. Biosimilar Markets — • The Weinberg Group Inc. Lessons for the U.S. Marketplace Organized By: Outstanding To Register, Call 800.817-8601 Support or Visit www.cbinet.com/ Provided by: biosimilars
C h O O S E F R O m T W O P R E - C O N F E R E N C E W O R k S h O P S — W E D N E S D aY, m a R C h 3 0, 2 0 11 7:30 Wo r k s h o p R e g i s t r a t i o n a n d C o n t i n e n t a l B r e a k fa s t 8:30 A. Explore the Reimbursement Landscape for Biosimilars and its Impact on Distribution SystemsWorkshop Objective: Workshop Leaders:In this workshop, hear both a payer and specialty pharmacy Nick J. Calla, RPh, is the Vice President of Trade Relationsperspective on the current reimbursement environment for follow-on biologics and its impact on distribution systems. Examine for Walgreens Specialty Pharmacy. He has the responsibilityshifts in healthcare policy and how public and private payers are of business development and maintaining the relationshipsmaking decisions regarding coverage. In addition, understand with manufacturers around the country as it relates to accessthe main drivers for biosimilar adoption and the need for extracomparative effectiveness studies (CER) to support safety and to particular products as well as the clinical programs designed toefficacy claims. Engage in discussion around how biosimilars are support those products. Prior to coming to Walgreens, Mr. Callapositioned for coding and reimbursement. worked as Director of Clinical Programs and Network AdministrationKey Questions to Be Addressed: for Eckerd Health Services. Mr. Calla was also President and General• How are changes in healthcare policy impacting the Manager of Oncology Pathways which was a group organization reimbursement system? founded by the UPMC Cancer Center and Medmark Specialty• What do private and public payers need to know to make decisions about biosimilars coverage? Pharmacy. Mr. Calla has experience working with both the• How are specialty pharmacies and other sites of service pharmaceutical manufacturing and retail pharmacy community and approaching distribution of follow-on biologic products given has also participated in several pharmacy and therapeutics the reimbursement climate? committees. He is a member of the National Association of Chain• What should a HCPCS coding strategy look like for biosimilars? Drug Stores, Academy of Managed Care Pharmacy and the Pharmaceutical Care Management Association. Mr. Calla hasWorkshop Outline: expertise in the area of compliance, disease management, interventionI. Healthcare Policy Shifts Impacting the programs and in the area of negotiations with providers for a network. Reimbursement System for Biosimilars Mr. Calla received his bachelor’s of pharmacy degree from theII. Current Reimbursement Climate for Biosimilars University of Pittsburgh, and a Juris Doctorate from Duquesne • Explore how biosimilars will be treated in the HCPCS coding system University. In addition, he has completed fellowship programs at the • Assess the landscape for Medicare and private University of Pennsylvania, University of Southern California and payer reimbursement Harvard University. * CER requirements • Analyze cost considerations James Langley is Vice President of Reimbursement for Accredo * challenges and opportunities with J-code blending Health Group, part of Medco Health Solutions. Mr. Langley * average sales price (ASP) has extensive experience across all aspects of biotech drugIII. Impact of the Reimbursement System on Distribution reimbursement on both a healthcare payment policy level and on an • Examine the specialty pharmacy role in biosimilars operating basis working directly with all types of payers in the U.S. • Consider other sites of service including physician reimbursement system. Mr. Langley has an active healthcare policy offices and hospitals role both on a provider level as part of Accredo Health Group and on a12:00 Close of Workshop A PBM level through Medco Health Solutions and, as such, has multipleThere will be a 30-minute networking and refreshment break at 10:00 a.m. “views” of the emerging biosimilar payment policy debates.
C h O O S E F R O m T W O P R E - C O N F E R E N C E W O R k S h O P S — W E D N E S D aY, m a R C h 3 0, 2 0 11 7:30 Wo r k s h o p R e g i s t r a t i o n a n d C o n t i n e n t a l B r e a k fa s t 8:30 B. Keys for Commercial Success in Ex-U.S. Biosimilar Markets — Lessons for the U.S. MarketplaceWorkshop Objective: III. Highly-Regulated MarketsRegional differences in competitive intensity, regulatory • Explore differences in requirements across U.S.sophistication and pricing are posed to require globalbiosimilar brands and portfolios to adapt new commercial and EU marketsstrategies. In this workshop, attendees examine three types • Assess the Japanese market for biosimilars andof regional biosimilar markets — emerging markets wheremultiple biosimilar brands already compete for share, new barriers to entrybiosimilar markets where the first entrants are competingversus innovator brands and the highly-regulated markets such IV. Lessons to Leverage in Your Product Developmentas the United States. Attendees benefit from analyzing marketsbeyond the U.S., gaining an understanding of the ex-U.S. and Commercialization Planbiosimilar markets and identifying key success strategies to • Apply global knowledge to overall product strategydrive brand development and adoption. and launchKey Questions to Be Addressed:• How do the key biosimilars markets outside of the U.S. 12:00 Close of Workshop B compare to one another? * what are factors for success in each? There will be a 30-minute networking and refreshment break at 10:00 a.m.• Who are the main players and their emerging competitors, if any? Workshop Leader:• What are the top barriers to brand adoption?• What role does product quality play and how Robert Ward is Managing Director for Harriman important is price?• How and when should companies consider foreign markets Biopartners, LLC, a strategic advisory firm. Mr. Ward in their development and commercialization strategies for works with the leaders of biopharmaceutical firms employing biosimilars?• How should companies apply lessons-learned from industry best practices for development and commercialization of ex-U.S. to the U.S. marketplace? global biopharmaceutical portfolios and partnerships. He brings• How should companies integrate these learnings into a global development strategy for biosimilars moving forward? over twenty-five years of industry experience gained though a careerWorkshop Outline: in commercial leadership roles with Bristol-Myers Squibb,I. Emerging Markets Pharmacia, Schering-Plough and Discovery Research at Genentech • Understand which regions are emerging in Inc. He has led several successful biosimilar/biobetter initiatives biosimilars development focusing on antibodies, proteins and peptides. He received a B.S. in • Assess current market leaders • Explore the regulatory climate of these regions Biological Sciences and a B.A. in Physiological Psychology from the University of California, Santa Barbara; an M.A. in ImmunologyII. Moderately-Regulated Markets • Analyze areas considered “moderately” regulated from Dr. Kimishige Ishizaka’s Laboratory at the Johns Hopkins • Understand the clinical trial requirements that University School of Medicine; and an M.S. in the Management of separate this market from “emerging” Technology from the School of Business at the New Jersey Institute • Examine current companies successfully working in this environment of Technology.
Main COnFEREnCE “I have found this Day One — Wednesday, March 30, 2011 12:00 Main Conference Registration conference a valuable 1:15 Day One Chairman’s Opening Remarks Bruce A. Leicher, Senior Vice President and General Counsel, Momenta Pharmaceuticals, Inc. resource as we Mr. Leicher is Senior Vice President and General Counsel at Momenta Pharmaceuticals Inc., an innovator biotechnology company engaged in form our biosimilar development of complex generic products, biogenerics and novel products with twenty years legal experience in the biotechnology industry. Before joining Momenta, he served in senior legal positions at Altus Pharmaceuticals Inc., str ategy for the Antigenics Inc., Millennium Pharmaceuticals, Inc., Curis, Inc., Genetics Institute, Inc. and Wyeth. In private practice, he served as the Co-Chair of the Life Sciences Practice Group at Hill and Barlow, and was an attorney at future.” Hale and Dorr and Butler & Binion after receiving his J.D. from Georgetown University Law Center and his B.A. from the University of Rochester. — 2010 Attendee, Nick Calla, assess Barriers to Utilizing the abbreviated Pathway Vice President Trade Relations, 1:30 November FDA Hearing — Review Stakeholder Perspectives and Discuss Steps toward Practical Walgreens Specialty Pharmacy Application of the Biosimilars Pathway The November hearing on the new biosimilar pathway provided an important opportunity for stakeholders to give feedback. Review various stakeholder perspectives, feedback from the hearing and assess potential next steps I n R E C O g n I T I O n for practical application of the pathway. O F O U R S P O n S O R : • Discuss generic, “hybrid” and brand company perspectives • Review feedback and key concerns raised at the meeting • Discuss next steps Jim Roach, M.D., FACP, FCCP, Senior Vice President, Development and CBI’s corporate sponsor represent select companies that Chief Medical Officer, Momenta Pharmaceuticals, Inc. share a common mission: business advancement through thought leadership, strategic interaction and innovation. The 2:15 Navigating the Patent Dispute Mechanism for company represented is a proud contributor on this program Biosimilars and FOBsand has carefully selected messaging, branding or positioning The Biologics Price Competition Innovation Act (BPCIA) treats patents and data exchange differently than previous statements to encourage the evaluation and investigation of P legislation. Patent dispute resolution clauses require quality products and/or services available. We applaud this A branded and generics companies to enter into multiple company, as well as others that wish to join the conference, data exchanges providing and allowing time to investigate as important members of this event’s delegation. If you are n lists of patents that may be infringed upon. This panel interested in sponsorship or exhibit opportunities, please call provides perspective on patent challenges, including the E nuances of this potentially-complex process. karen hanover at 339-298-2184 or email firstname.lastname@example.org L • Examine data exchange requirements and parameters of the new pathway • Understand timelines for notification and response — Potential areas to delay or speed up litigation Outstanding Moderator: Support Samuel E. Webb, Provided by: Partner, Stoel Rives LLP. Panelists: Sean Ryder, Director of Legal, Glenmark Pharmaceuticals Suzanne Munck, Counsel for Intellectual Property, Federal Trade Commission Anne Dollard, Deputy General Counsel, Chief Patent Counsel, Takeda To Register Call Toll Free 800-817-8601 (339-298-2100 outside the U.S.) or Fax 781-939-2490. Register on our website at www.cbinet.com/biosimilars
3:15 Networking and Refreshment Break Dr. Castagna is Executive Director, Orencia at Bristol-Myers Squibb. Previously, he was Vice President Sales and Marketing for the analyze Market Competition Biopharmaceutical division at Sandoz where he built the infrastructure and the Future Shape of innovator and strategy for the Sandoz follow-on biologics/biosimilar business in the and FOB Companies U.S. His responsibilities included driving the commercial performance of the company’s human growth hormone Omnitrope® and planning3:45 Follow-On Biologics — future pipeline products. His career spans over fourteen years in the FTC Perspective on Market Competition pharmaceutical industry as well as community and specialty pharmacy. In June of 2009 the FTC released a report describing His experience includes new product market assessment and launch, how an abbreviated regulatory approval pathway for brand revitalization, portfolio management and strategic planning. follow-on biologics would likely affect the market Dr. Castagna previously worked for EMD (Merck) Serono where he dynamics for biologics. With the passing of PPACA, served as Director, Endocrinology and Reproductive Health Marketing, that time is now. During this session, hear the FTC responsible for the U.S. marketing of Gonal-f, Saizen, Zorbtive and speak to mergers, acquisitions and patent licensing Serostim. Prior to EMD Serono, he was with Pharmasset, Inc. and issues surrounding FOBs, including biologics Bristol-Myers Squibb where he held positions of increasing responsibility (recombinant proteins and monoclonal antibodies), in the areas of product management and strategy. Dr. Castagna received biosimilars and biobetters. his Pharmacy degree from Philadelphia College of Pharmacy and holds a MBA from The Wharton School at the University of Pennsylvania. • Analysis of market dynamics with FOB entry, including effects on share and price 8:15 Will Innovative Companies Be Able to Build and • Anti-competitive and unfair methods of competition, Compete in a Biosimilars World? including patent settlements and patent pools As the line between companies developing innovator • How reimbursement policies shape market dynamics and biosimilar products blurs and companies begin • Hypothesis on the future of FOBs and the effect of to do both, they must have expertise and processes PPACA on biologics market competition in-house to successfully develop both product Suzanne Munck, Counsel for Intellectual Property, portfolios. In this session, explore the opportunities, Federal Trade Commission differences and synergies between brand and biosimilar4:30 A Prospective Look at the Shape of Biosimilar and management from a commercial perspective. Innovator Companies in Five to Ten Years • Understand differences and similarities in successfully This session examines the evolution of the drug business launching an innovative versus biosimilar biologic and specifically the paths taken by leading innovator, • Discuss synergies that should be leveraged in generics and biosimilars manufacturers. Understand managing both product portfolios within one company trends and movement of these companies based on • Explore whether innovator companies can build a market drivers, risks taken, successes and failures. biosimilars presence and compete With this background, engage in discussion of the future shape of the biologics market. Michael Castagna, Pharm.D., Executive Director, Orencia, • Examine the paths of current innovators and Bristol-Myers Squibb; Former Vice President, biosimilars companies while considering the Sales and Marketing Biopharmaceuticals, Sandoz Inc. evolutions of innovator and generic manufacturers 9:00 Differentiated Biosimilars — Is It Worth • Understand successes and failures Developing for Incremental Market Share? • Look prospectively at the landscape Differentiated biosimilars have a distinct marketing in the next five to ten years advantage created by a noticeable difference in product Joseph P. Fuhr, Jr., Ph.D., Professor of Economics, Widener University features. These features are meant to influence clinician5:15 Close of Day One prescribing patterns and/or payer reimbursement levels. Differentiated biosimilars already exist in the marketplace, but competitors dismiss the differentiated 5:15-6:15 Networking, Photo by: Photolink / Getty Images product features as meaningless. This presentation Wine & Cheese Reception explores, for the first time, whether it is worth the effort Join colleagues and friends in a relaxed setting. of developing differentiated biosimilars by examining the potential payoff in incremental market share in various world markets. Day Two — Thursday, March 31, 2011 • Hear examples of differentiated products7:30 Continental Breakfast • Debate the development effort versus8:00 Day Two Chairman’s Review of Day One market share benefits Michael Castagna, Pharm.D., Executive Director, Orencia, Richard L. DiCicco, Chairman, Harvest Moon Pharmaceuticals USA, Inc. Bristol-Myers Squibb; Former Vice President, Sales and Marketing Biopharmaceuticals, Sandoz Inc. 9:45 Networking and Refreshment Break To Register Call Toll Free 800-817-8601 (339-298-2100 outside the U.S.) or Fax 781-939-2490. Register on our website at www.cbinet.com/biosimilars
Luncheon 11:45 Explore the Risks and Optimize Clinical Development and Benefits of Biosimilars Utilization of Biosimilars10:15 Understand the Perils and Profits Available through 1:00 Therapeutic Areas Poised for Early Biosimilars the 12-year Non-Patent Exclusivity Development and Acceptance One of the most controversial clauses of the Biologics These breakouts provide the opportunity to discuss the Price Competition and Innovation Act of 2009 (BPCIA) therapeutic areas that are best-positioned for biosimilars was its creation of 12 years of exclusive marketing for development and acceptance. Attendees form roundtables biologics approved as “full” BLAs. Regarded as essential to discuss the commercial feasibility, specific challenges and for the innovative industry to be able to recoup its costs strategies to gain acceptance within a particular therapeutic of development, the law was supposedly crafted to avoid area. Each group appoints a leader during the time of the generic industry claims that innovators could “evergreen” breakout. After the introduction, groups have an hour to ROUNDTaBlE discuss their problems/topics and then reconvene to share their products by making incremental changes to their DISCUSSION findings and best practices with the entire room. products. This session explores the impact of the new exclusivity provisions with a focus on whether the Key Questions to Be Discussed: language allows for abuses by brand name firms and how • How would biosimilars affect the therapeutic community? biosimilar applicants can try to avoid the bar of approval • What changes would clinicians/practitioners expect? created by exclusivity. In addition, examine the 2-year • Are price reductions likely? exclusivity period available under the BPCIA to the first approved interchangeable biosimilar that bars subsequent • What are patient safety considerations? interchangeable biosimilars for the same product. • What education would benefit practitioners/prescribers Michael A. Swit, Esq., Vice President, The Weinberg Group Inc. in this therapeutic area? Moderator: Sean Maduck, Senior Manager, Commercial Business10:45 Balancing the Risks and Benefits of the Operations, Genentech — A member of the Roche Group Abbreviated Pathway in the Context of Overall Therapeutic Areas of Discussion: Business Strategy 1. Oncology — Adjuvant Treatment The abbreviated pathway offers substantial risks and benefits 2. Oncology — Metastatic Treatment to a traditional BLA, as discussed previously. In this panel, 3. Rheumatoid Arthritis hear how companies are actively taking these factors into P consideration in planning their development strategy. 2:30 Biosimilars Nomenclature and Implications for the • Are companies picking one pathway or the other? U.S. Biopharmaceutical Industry A Or, will pathway selection be more biologic The next major controversy regarding biosimilars is product dependent? product nomenclature. The names to be used in commercen for biosimilars affect the underlying perceptions about • What factors will influence the choice? E these products (how unique, innovative, generic or not * regulatory risk, regulatory pathway uncertainty they are), and largely control how they can be marketed. L and time to approval Uniquely-named products require marketing much like * clinical development cost any innovator product, with no indication it is a biosimilar product. Similar names identify products as biosimilar, * patent clearance costs and facilitate switching to biosimilars and involve minimal patent clearance process uncertainty marketing (like generic drugs). Recent legislation totally * complexity of the biologic avoids the issue of names and the FDA is expected to go * potential for interchangeability with unique names for every product, until a true biogeneric • How are companies weighing each factor? is approved. In this session, we explore what type(s) of name(s) FDA may use for biosimilars, the names to be used Moderator: for other purposes, and how these impact the interests of Michael A. Swit, Esq., different user communities. Vice President, The Weinberg Group Inc. • Explore nomenclature considerations for biosimilars: Panelists: * how names control perception and marketing Bruce A. Leicher, * how unique or generic, meaningful or Senior Vice President and General Counsel, meaningless should names be? Momenta Pharmaceuticals, Inc. * current nomenclature systems and options Sean Maduck, * vastly conflicting needs of different user communities Senior Manager, Commercial Business Operations, • Who will propose, control and track names? Genentech — A member of the Roche Group Who will win, and who will lose? Richard L. DiCicco, Ronald A. Rader, President, Biotechnology Information Institute Chairman, Harvest Moon Pharmaceuticals USA, Inc. 3:15 Close of Conference To Register Call Toll Free 800-817-8601 (339-298-2100 outside the U.S.) or Fax 781-939-2490. Register on our website at www.cbinet.com/biosimilars
Register by January 28, 2011 and Receive $300 Off of Your Registration Fee! C B I ’ s 6 t h S u m m i t o n — Top Reasons to attend — • Explore how biosimilars will be treated in the Biosimilars and HCPCS coding system • Hear generic, hybrid and brand company perspectivesFollow-On Biologics • Examine data exchange requirements and parameters of the new pathway A nD! Leverage the Regulatory, Legal and Clinical Realities Choose from Two Pre-Conference Workshops on Wed., March 30, 2011: Explore the Reimbursement of the Biologics Price Competition and Innovation Act to A: Landscape for Biosimilars and its Impact on Distribution Systems Achieve Maximum Commercial Value B: Keys for Commercial Success in Ex-U.S. Biosimilar Markets — March 30-31, 2011 • The Westin Tysons Corner • Falls Church, VA Lessons for the U.S. Marketplace The Next Best Thing to Being There… CBI PRSRT STD 600 Unicorn Park Drive • Woburn, MA 01801 U.S. PostageOrder the Online Compendium if you would like to capture what you’ve missed PAIDat the conference. It couldn’t be easier. The link to the online compendium is Galleryavailable for only $198 and includes the conference agenda, presentations and speakers’ biographies. Don’t miss out on this valuable information presented by industry leaders exclusively at this event. Simply fill out the order form and submit via phone, fax or website and you’ll receive the link to the Online Compendium within 2 weeks after the conference.• Registration Fee: Standard Advantage Pricing Conference & Workshop $2,095 $1,795 Conference only $1,795 $1,495 Advantage Pricing — Register by January 28, 2011 and SAVE $300. Fee includes continental breakfast, lunch, wine and cheese reception, refreshments and Online Compendium. Please make checks (in U.S. funds drawn on a U.S. bank) registration Card DO NOT REMOVE MAILING LABEL. PLEASE RETURN ENTIRE FORM. PC11014 payable to CBI Research, Inc. (No personal checks accepted) advantage Pricing may not be combined with other discount offers, special category rates or promotions. Discounts only apply to standard rates. Yes! Please register me for CBI’s 6th Summit on Biosimilars and Follow-On Biologics.• Team Discount: Conference & Workshop a Conference & Workshop B Conference only Your organization may send 1 executive free for every 3 delegates registered. all registrations must be made at the same time to qualify. I am registering for ADVANTAGE PRICING We would like to take advantage of the TEam DISCOUNT (see left for details).• Accommodations: Yes! Please send me the link to the Online Compendium. I am unable to attend the conference. To receive CBI’s special discounted hotel rate on line or by phone, please go to: Register 3 • On-line: www.cbinet.com/biosimilars Do you have any special needs? ________________________________________________ Get 1 FREE • Phone reservations: 800.937.8461 and mention CBI’s 6th Summit on KEY CODE (appears above mailing address): ___________________________________ Biosimilars and Follow-On Biologics. Cut-off date is March 7, 2011. Reservations made after the cut-off date or after group room block has been filled (whichever comes first) will be accepted 1. NamE POSITION on a space and rate availability basis. Rooms are limited so please book early. all travel arrangements are subject to availability. 2. NamE POSITION• Venue: 3. NamE POSITION The Westin Tysons Corner 7801 Leesburg Pike • Falls Church, VA 22043 4. NamE POSITION hotel reservations: 800.937.8461 Free hotel direct line: 703.893.1340 COMPANY DIVISION• Substitution & Cancellation: aDDRESS 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 CITY STaTE/COUNTRY ZIP/POSTal CODE prior to the start date of the event will be refunded, less a $195 administrative charge. No refunds will be made after this date; however, the registration fee less the $195 TElEPhONE Fax E-maIl 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 AUThORIzED SIGNATURE 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 Payment Options: Payment in full is required to process registration. Please call with any payment questions. 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 Enclosed is a check for payment in full (No personal checks accepted) Please without notice. The opinions of the conference faculty do not necessarily reflect those of the companies they represent or The Center for Business Intelligence. MC/Visa: photocopy this form for additional• Satisfaction Guaranteed: amex: delegates. 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 NamE (aS aPPEaRS ON CaRD) ExP. DaTE CBI conference of your choice. Please contact 800-817-8601 for further information. CARDhOLDER SIGNATURE advanced preparation for CBI conferences is not required. WeBSiTe Phone fAX e-MAil MAil 5 Easy Ways www.cbinet.com/ biosimilars 800-817-8601 781-939-2490 email@example.com CBI Registration Dept. 339-298-2100 Please include all information 600 Unicorn Park Drive to REgistER outside the U.S. requested on registration card. Woburn, ma 01801