Buchanan's Life Sciences Team by Buchanan Ingersoll & Rooney

• Food and Drug Administration

Buchanan’s Life Sciences Team

• Antitrust and Trade Regulation

Christopher L. North, Ph.D. Alexandria, Virginia 703 838 6511 christopher.north@bipc.com Shantanu C. Pathak, Ph.D. Philadelphia, Pennsylvania 215 665 3939 shantanu.pathak@bipc.com

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Duane A. Stewart, III Pittsburgh, Pennsylvania 412 562 1622 duane.stewart@bipc.com

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Theodore M. Sullivan Washington, D.C. 202 452 7992 theodore.sullivan@bipc.com

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Richard G. Salazar Tampa, Florida 813 222 1142 richard.salazar@bipc.com

Carla J. Vrsansky Pittsburgh, Pennsylvania 412 562 1639 carla.vrsansky@bipc.com

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Todd R. Walters Alexandria, Virginia 703 838 6556 todd.walters@bipc.com

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Mark M. Yacura Washington, D.C. 202 452 7949 mark.yacura@bipc.com

Howard D. Scher Philadelphia, Pennsylvania 215 665 3920 howard.scher@bipc.com Stephany G. Small, Ph.D. Patent Agent Wilmington, Delaware 302 552 4247 stephany.small@bipc.com

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Samantha L. Southall Philadelphia, Pennsylvania 215 665 3884 samantha.southall@bipc.com Genevieve M. Spires Newark, New Jersey 973 424 5612 genevieve.spires@bipc.com

Michael S. Powers Princeton, New Jersey 609 987 6804 michael.powers@bipc.com

Donald V. Scaltrito, Ph.D. Patent Agent Alexandria, Virginia 703 838 7571 donald.scaltrito@bipc.com

4 Complementary Bases That Express Your Potential

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Aaron L. J. Pereira New York, New York 212 440 4468 aaron.pereira@bipc.com

Linda Pissott Reig Newark, New Jersey 973 424 5618 linda.reig@bipc.com

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S. Lloyd Smith Alexandria, Virginia 703 838 6514 lloyd.smith@bipc.com

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Buchanan’s Life Sciences Team brings together focused experience of four practice areas. With a depth of talent in strategic locations, we have the resources to tailor a team specific to your needs. From discovery to market, Buchanan’s Life Sciences Team will help you express your potential.

Intellectual Property • Intellecual Property Procurement • Intellectual Property Enforcement Procurement Buchanan offers a full-service IP Section, the cornerstone of which is the intellectual property procurement group. Whether you need a patent, trademark or copyright, Buchanan will ably assist you at every turn.

Patents Buchanan boasts over 50 practitioners registered to practice before the United States Patent and Trademark Office. In 2014, we prosecuted over 2,100 applications and helped our clients obtain 1,682 U.S. patents. Calling upon our network of foreign counterparts, we helped our clients prosecute over 550 foreign applications and obtain 342 patents in 2014. Application Drafting An invention’s value often turns on the quality of the patent embodying it. Because our team members are versed in life sciences, we can readily understand an inventor’s contribution to the art, and we work directly with inventors to capture and claim the full invention. We follow case law developments in the Life Sciences area and draft applications that satisfy current standards yet leave options open should shifts occur. Prosecution Buchanan’s IP Section prides itself on cross-training. Our patent prosecutors have litigation experience and realize that every word in a file history is carefully analyzed. As a result, our patent prosecutors draft accurate and efficient responses. Should an Examiner fail to appreciate a given invention based upon written responses, Buchanan frequently takes advantage of its location and conducts in-person interviews with Examiners. Buchanan’s flagship IP office is in Alexandria, Virginia, just blocks away from the Patent Office. Opinions Key business decisions rest upon analyses not only of your IP, but also that of your competitors. Whether the issue is validity/invalidity, infringement/non-infringement or both, we can help you determine whether to stay the course or modify your tentative plan so as to minimize risk. Diligence Investigations Whether you seek to acquire a patent portfolio or seek to transfer your patent portfolio, diligence investigations involve a detail-oriented process. From verifying that the “owner” truly owns the property to determining whether the risks in the transaction outweigh the potential rewards, Buchanan’s Life Sciences Team can assist with every step. Licensing A key reason to have patents is to monetize them. We have experience with issues encountered in life sciences licensing transactions, including those associated with inter-institutional agreements, federal funding, cooperative research and development agreements, the Bayh-Dole Act, F/RAND and export control.

• Food and Drug Administration

Buchanan’s Life Sciences Team

• Antitrust and Trade Regulation ••

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Christopher L. North, Ph.D. S. Lloyd Smith Portfolio Management Alexandria, Virginia Alexandria, Virginia Obtaining a patent is just one hurdle along the life cycle of an invention. Buchanan’s Life 703 838 6511 703 838 6514 Sciences Team will help you chart out how best to fully protect an invention, be it with one or christopher.north@bipc.com lloyd.smith@bipc.com many patents. Buchanan offers institutional knowledge of the invention from its inception, and we use that knowledge to assist you in deciding what assets to retain and enforce. Samantha L. Southall Shantanu C. Pathak, Ph.D. Patent Term Adjustment Philadelphia, Pennsylvania Philadelphia, Pennsylvania Every day of patent term3939 matters, especially in the life sciences world. Due 215 to our665 familiarity 215 665 3884 with PTA-triggering events, our patent prosecutors work with you to maximize valuable term. In shantanu.pathak@bipc.com samantha.southall@bipc.com addition, Buchanan’s team can verify PTA calculations performed by the PTO and can challenge erroneous calculations. Aaron L. J. Pereira Genevieve M. Spires Patent Term Extension New York, New York Newark, New Jersey Applying for PTE a seemingly it important 212is 440 4468 straight-forward task but one that brings with 973 424 5612 consequences.aaron.pereira@bipc.com From helping to analyze which patent in the portfolio shouldgenevieve.spires@bipc.com be extended to shepherding the application through the regulatory channels, Buchanan can advise you at every turn. Michael S. Powers Duane A. Stewart, III Princeton, New Jersey Pittsburgh, Pennsylvania Biosimilars/Biologics 609 987 6804 412fi562 1622 The Biologics Price Competition and Innovation Act (BPCIA) became law almost ve years ago, michael.powers@bipc.com duane.stewart@bipc.com and the import of the Act is now emerging. Our team can help you navigate the biosimilars world

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4 Complementary Bases That Express Your Potential

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From discovery to market, Buchanan’s Life Sciences Team will help you express your potential.

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—from pre-litigation considerations to discovery mechanisms to actual litigation.

• Trademarks Newark,and New Copyrights Jersey

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Linda Pissott Reig

Theodore M. Sullivan Washington, D.C. 973 424 5618 202 452 7992 Buchanan’s Trademark and Copyright Group includes attorneys and paralegals who handle all linda.reig@bipc.com theodore.sullivan@bipc.com aspects of trademark and copyright matters, including investigation and clearance, registration and maintenance, opposition and cancellation proceedings at the Trademark and Trial and Appeal Board (TTAB), Richard federal andG. state court litigation involving the protection and enforcement of Salazar Carla J. Vrsansky Tampa, Florida Pittsburgh, Pennsylvania trademarks and copyrights, and administrative litigation at the International Trade Commission 222 1142in remedies against trademark and service mark 412counterfeiting 562 1639 on (ITC). The firm813 has experience richard.salazar@bipc.com carla.vrsansky@bipc.com the Internet. We also handle preparing and filing copyright applications and have experience in all aspects of copyright litigation, including notice and takedown demands and safe harbor defenses Donald V. Scaltrito, Ph.D. under the Digital Millennium Copyright Act. Todd R. Walters Patent Agent

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Alexandria, Virginia Alexandria, Virginia Product Naming 703 838approval 6556 703 838 7571 Our trademark lawyers represent life sciences companies in selecting and obtaining todd.walters@bipc.com donald.scaltrito@bipc.com of product names for prescription and over-the-counter drugs. We research, review and vet possible trademarks with our clients and guide them through each phase of the naming process. Mark M. Yacura Howard D. Scher Counterfeit Products Washington, D.C. Philadelphia, Pennsylvania Because the value of a product can be undermined by harmful or ineffective counterfeits, our 202 452 7949 215 665 3920 Trademark Group develops strategies to uncover and combat counterfeit goods in the markets. mark.yacura@bipc.com howard.scher@bipc.com Buchanan’s trademark lawyers are prepared to work aggressively to obtain injunctions and Small, Ph.D. seizure ordersStephany and to take G. other steps to minimize the harm to our clients a the public. Patent Agent Alfred W. Zaher Wilmington, Delaware Philadelphia, Pennsylvania 302 552 4247 215 665 3880 stephany.small@bipc.com alfred.zaher@bipc.com

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Intellectual Property Enforcement Patents, trademarks and copyrights permit the holder to exclude others from encroaching upon the protected area. Buchanan’s Life Sciences Team helps patent, trademark and copyright holders decide whether their rights are being threatened and, if so, when and how to take action. Our team also helps alleged infringers determine whether the infringement allegations are well-founded and whether the underlying intellectual property is valid. We are sensitive to the invasive nature of litigation, as well as the costs associated with enforcement. Drawing upon the technical knowledge of our deep bench, we tailor each litigation team to your particular needs.

Traditional Litigation Buchanan’s IP Litigation Group offers the resources and experience of a general practice firm but with the focus of an IP boutique. We handle patent, trademark, copyright, trade secret, unfair trade/competition, ITC and arbitration matters from the initial tribunal through the highest appellate court.

Patent Patent litigation is complex, and the amount in controversy in the life sciences space is often very high. Our litigators roll up their sleeves and truly learn the technology, which enables them to develop efficient litigation strategies. We have handled many life sciences cases involving chemicals, pharmaceuticals, genetically-modified organisms and medical devices.

Trademark Buchanan’s trademark litigators handle a wide range of trademark disputes, including all types of trademark infringement and dilution claims, counterfeiting, gray-market goods, domain name claims and licensing disputes. We also assist our life sciences clients in disputes before nonjudicial forums, including ex parte and inter partes registration and cancellation disputes before the TTAB and anti-counterfeiting enforcement through the United States Customs & Border Protection Service.

Copyright Our copyright litigators understand and work through key issues in copyright disputes, including originality, fair use, work-for-hire agreements and ownership, public domain, the Digital Millennium Copyright Act, Orphan Works and database protection.

Trade Secret Trade secrets can be among a life science company’s most valuable assets. In today’s competitive global marketplace, it is all too easy for a trade secret to be revealed, especially in light of the mobility within the life sciences sector. Our litigation team handles a broad spectrum of scientific, factual, legal and procedural issues in all state and federal courts, and we are prepared to proceed under all state and federal statutes and regulations, the Uniform Trade Secrets Act, the Federal Economic Espionage Act and state business tort laws.

• Food and Drug Administration

Buchanan’s Life Sciences Team

• Antitrust and Trade Regulation ••

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Christopher L. North, Ph.D. S. Lloyd Smith Alexandria, Virginia Alexandria, Virginia Buchanan’s litigators are familiar with the substantial body of federal and state law directed to 703 838 6511 703 838 6514 unfair trade practices and unfair competition, including laws that prohibit false advertising. False christopher.north@bipc.com lloyd.smith@bipc.com advertising can be especially harmful in the life sciences area. We develop creative strategies using the Lanham Act and other tools to protect our clients against unfair competition in various Samantha L. Southall Shantanu C. Pathak, Ph.D. forms, including false product comparisons and scientific claims made without proper testing Philadelphia, Pennsylvania Philadelphia, Pennsylvania and verification. 215 665 3939 215 665 3884 International Trade Commission shantanu.pathak@bipc.com samantha.southall@bipc.com The ITC provides a specialized, fast-paced venue for solving intellectual property disputes, including for life science companies. Whether you are a complainant or respondent, our litigators L. J.ofPereira Genevieve M. Spires can assist withAaron every step the process from development of theories for domestic industry New York, New York Newark, New Jersey assertions to the full scope of invalidity attacks and defenses. 212 440 4468 973 424 5612 Arbitration aaron.pereira@bipc.com genevieve.spires@bipc.com Because the courts are not the only, best or most cost-effective forum for many disputes, our IP litigators are experienced in domestic and international arbitration of patent, trademark and Michael S. Powers Duane A. Stewart, III copyright disputes. Our team members use this experience to counsel clients on the advantages Princeton, New Jersey Pittsburgh, Pennsylvania of arbitration in certain IP disputes. 609 987 6804 412 562 1622 michael.powers@bipc.com duane.stewart@bipc.com

Unfair Trade and Unfair Competition

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4 Complementary Bases That Express Your Potential

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From discovery to market, Buchanan’s Life Sciences Team will help you express your potential.

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Hatch-Waxman (Paragraph IV) Litigation

Ever since its adoption, members of Buchanan’s Life Sciences Team have counseled companies Linda Pissott Reig Theodore M. Sullivan with Paragraph IV litigation under the Hatch-Waxman Act. We staff our Paragraph IV teams Newark, New Jersey Washington, D.C. in a manner that makes sense for the particular dispute. We endeavor to minimize invasive, 973 424 5618 202 452 7992 expensive discovery that does not bear on the merits of the validity and infringement challenges. linda.reig@bipc.com theodore.sullivan@bipc.com We work with our FDA and Antitrust groups to stay abreast of developments in these overlapping areas. Because members of our team are located in key Paragraph IV locations—Delaware Richard Salazar Carla J. Vrsansky (Wilmington), New JerseyG. (Trenton and Newark), New York (New York City), and Virginia Tampa, (Alexandria, home of theFlorida “Rocket Docket”)—the expense of local counsel isPittsburgh, obviated. Pennsylvania 813 222 1142 412 562 1639 richard.salazar@bipc.com carla.vrsansky@bipc.com Concurrent Proceedings

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Gone are the days of single patent, single proceeding litigation. Life sciences companies Donald V. Scaltrito, Ph.D. R. Walters Patent Agentproceedings on several assets, which can drainTodd increasingly face concurrent precious resources. Alexandria, Alexandria, Due to our team’s familiarityVirginia with each type of concurrent proceeding, we can work with Virginia you 703 838 6556 703 838 7571 to determine whether a multi-proceeding path is wise and can advise you on what to expect at todd.walters@bipc.com donald.scaltrito@bipc.com each phase. For example, IPRs (detailed below) are now a complement to traditional Paragraph IV litigation. We counsel pharmaceutical companies about the pros and cons of using IPRs and on how best toHoward navigate D. suchScher proceedings. If you are faced with concurrentMark proceedings, we will M. Yacura quickly assemble a team to vigorously protect your assets. Washington, D.C. Philadelphia, Pennsylvania

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202 452 7949 mark.yacura@bipc.com

215 665 3920 howard.scher@bipc.com Stephany G. Small, Ph.D. Patent Agent Wilmington, Delaware 302 552 4247 stephany.small@bipc.com

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(continued) Alfred W. Zaher Philadelphia, Pennsylvania 215 665 3880 alfred.zaher@bipc.com

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Intellectual Property Enforcement (continued from previous page)

Interferences Buchanan offers an interference team that has handled hundreds of interferences before what is now the Patent Trial and Appeal Board (the Board). While interferences are being phased-out due to the transition to first-inventor-to-file, many cases in the life sciences field remain vulnerable to interference practice. Our interference practitioners can work with you to position your portfolio so as to provoke an interference and then assist you with every step of the process. Should you unexpectedly find yourself in an interference, we can work with you to develop validity attacks on your opponent. Buchanan’s experience with all phases of interference practice and our familiarity with the Board removes what would otherwise be unknowns associated with an “arcane” practice.

Inter Partes Reviews (IPRs) The America Invents Act (AIA) brought about several new types of post-grant proceedings, including IPRs. IPRs are modeled closely after the motions phase of an interference, and Buchanan has effectively transitioned its interference experience to IPR practice. To date, we have assisted with over 35 IPRs, on behalf of both patent owners and petitioners. For petitioners, we help identify art, retain experts, formulate bases to efficiently attack the targeted claims, and draft persuasive petitions. For patent owners, we develop a coherent strategy to protect the patent, retain experts, decide whether to file a preliminary response and whether to amend, and draft persuasive responses. Our versatility in these proceedings allows us to craft and execute an appropriate strategy, anticipate our opponent’s next move, and create an appropriate record should the matter proceed to appeal.

Post Grant Reviews (PGRs) Subject matter eligibility, written description and enablement issues are key concerns to our life sciences clients. While not appropriate for IPRs, which are limited to anticipation and obviousness attacks, these issues can be pursued using a PGR. Our team can help you determine if a PGR is the right way to challenge your competitor and can help defend you should your property face one of these new attacks. In time, a PGR will also become a possible alternative to traditional Paragraph IV litigation.

Reissue and Reexamination Our patent reissues team has the in-depth knowledge our clients have come to expect, particularly when they are considering filing patent infringement litigation to enforce their intellectual property rights. Reissue proceedings are similar to standard patent prosecutions, but critical differences between the two can lead to a poor outcome if they are not handled correctly. Our experience in both broadening and narrowing reissue applications and in reissue protests provides our clients with full access to this sometimes critically valuable option. Many defendants and some plaintiffs in patent litigation are interested in reexamination requests, an option with both benefits and serious risks. We are ready to advise our clients about the complex strategic decisions presented by reexamination requests.

Food and Drug • Antitrust and Trade Regulation Administration Group

Buchanan’s Life Sciences Team

• Food and Drug Administration

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Christopher L. North, Ph.D. S. Lloyd Smith Alexandria, Virginia Alexandria, Virginia Buchanan’s703 Life838 Sciences 6511 Team provides clients a robust and 703well838 6514 respected christopher.north@bipc.com practice focusing on the Food and Drug Administration (FDA). lloyd.smith@bipc.com

4 Complementary Bases That Express Your Potential

The strength of our dedicated FDA Group, practicing out of Buchanan’s Washington, D.C.; Newark, NewPh.D. Jersey.; and Princeton, New Jersey L. Southall Samantha Shantanu C. Pathak, offices, is based upon the seamless interaction amongst our group Philadelphia, Pennsylvania Philadelphia, Pennsylvania 665as 3939 215 665 3884 members, 215 as well our colleagues in Buchanan’s healthcare, government shantanu.pathak@bipc.com relations, intellectual property and litigation groups. Many ofsamantha.southall@bipc.com our team members have worked for the FDA, U.S. Congress or Drug Enforcement Aaron L. J. Other Pereirateam members have worked for Genevieve M. Spires Administration (DEA). drug New York Newark, New companiesNew andYork, research institutes as scientists or legal counsel. We areJersey 212 440 4468 973 424 5612 uniquely qualifi ed to provide a variety of services for manufacturers of aaron.pereira@bipc.com genevieve.spires@bipc.com pharmaceuticals, medical devices, foods, supplements, nutraceuticals and biologics.

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Michael S. Powers Duane A. Stewart, III Princeton, New Jersey Pittsburgh, Pennsylvania 609 987 6804 412 562 1622 Key Focus Areas Include: michael.powers@bipc.com duane.stewart@bipc.com New Products and Market Approval We advise clients on the pharmacogenomic, preclinical, bench, animal, clinical testing, clinical Linda Pissott Reig Theodore M. Sullivan trial and marketing application requirements to support approval or clearance of drug, biological, Newark, New Jersey Washington, D.C. medical device and combination (drug-device-biologic) products. We work with our clients 973 424 5618 202 452 7992 to prepare and submit NDAs and ANDAs; NADAs and ANADAs; BLAs and HCT/P registrations linda.reig@bipc.com theodore.sullivan@bipc.com and listings; PMAs and 510(k) notifications; INDs and IDEs; combination product requests for designation (RFDs); product jurisdiction determinations; citizen petitions; appeals of agency Richard G.opinions Salazar J. Vrsansky action; food additive GRAS and petitions; PDUFA and MDUFMA userCarla fee waivers; and Floridaproduct, and medical device approvals and clearances. Pittsburgh, Pennsylvania Pan-EuropeanTampa, drug, biological 813 222 1142 412 562 1639 Clinical Trials richard.salazar@bipc.com carla.vrsansky@bipc.com Our team provides clients with legal strategies for developing biologics, medical devices and drug V. Scaltrito, products that Donald have the optimal chance Ph.D. of attaining passage through the FDA review process. With R. Walters Patent Agent our experience, we are able to identify technologies and experts that assist Todd companies not only Alexandria, Virginia Alexandria, Virginia in protecting their existing products but also in expanding the life cycle of their products through 703 838 6556 703 838 7571 new technologies, patents, studies and more. For clients that have already developed a protocol, todd.walters@bipc.com Buchanan candonald.scaltrito@bipc.com provide the legal advice and contract documents necessary during the execution of the clinical research process. Mark M. Yacura D. Scher Advertising Howard and Promotion Washington, D.C. Philadelphia, Pennsylvania We handle all aspects of marketing of FDA-regulated products. We evaluate promotional 202 452 7949 215 665 3920 materials for compliance with FDA requirements, as well as to reduce risks of product liability mark.yacura@bipc.com howard.scher@bipc.com and Lanham Act claims. We counsel companies on lawful preapproval communications, including Stephany G. Small, dossier development to obtain managedPh.D. care approval. We participate in regularly scheduled Patent Agent and evaluate items, such as slim jims, master Alfred Zaher promotional review committees visualW. aids, Wilmington, Delaware Philadelphia, websites, file cards, reprint carriers, journal advertisements and slide kits. We also addressPennsylvania 552 4247 215 665 3880 dissemination302 of medical journal articles, promotional speaker programs, scientifi c convention stephany.small@bipc.com alfred.zaher@bipc.com (continued)

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From discovery to market, Buchanan’s Life Sciences Team will help you express your potential.

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Food and Drug Administration Group (continued from previous page)

participation, advisory board management and utilization of social media tools. We counsel on the state and federal laws on Sunshine Act/aggregate spend disclosure, spending limits and prohibitions and compliance program adherence.

Drug Safety We work to assess the various issues associated with drug safety, adverse event reporting and manufacturing. FDAâ&#x20AC;&#x2122;s increased regulation of manufacturing and drugs in gray regulatory areas has led us to work directly with the agency to try to ensure its actions are justified. In many cases, we have been able to convince the agency that injunctions against clients were inappropriate, that seizures of goods were unnecessary and the recalls of the goods were unwarranted.

Regulatory Compliance and Enforcement We apply our cross-functional knowledge to help our clients comply with regulatory requirements at every phase of a productâ&#x20AC;&#x2122;s lifecycle, from development and manufacturing through marketing and distribution. We also create highly effective plans for addressing compliance issues related to clinical trials and the manufacture, marketing and distribution of human and animal drugs, biological products, medical devices, combination products, tissue-based and gene therapy products, foods and cosmetics. We help our clients stay ahead of what is next by keeping our eyes on what is happening with the FDA, the Federal Trade Commission (FTC) and the Department of Justice (DOJ). We make sure our clients know what may be newly required in preapproval and post-approval inspections, advertising and promotion, good manufacturing practice and quality system regulations, import-export, clinical trial monitoring, post-market surveillance and administrative and judicial enforcement actions.

Government Investigations Our multidisciplinary team is experienced in navigating the intricacies of government investigations. We frequently represent clients before the DOJ, the FTC, state attorneys general and various other federal and state regulatory agencies. In addition to representing clients facing antitrust or unfair trade practices allegations, we counsel individual clients who are subpoenaed to testify as third-party witnesses, as well as clients with an interest in such investigations. In addition, we have conducted internal investigations and advised clients with respect to compliance with antitrust regulations, as well as other state and federal laws governing business and commerce.

International Markets We have dealt with regulatory agencies in Canada, Europe, the Pacific Rim, the Middle East and South Africa. Conversely, we have helped companies from all over the world market their products in the United States. Product licensing and joint venture agreements are an important part of international business. Our group provides companies entering such agreements with economic and financial analyses of the products and markets involved. We also analyze the

• Food and Drug Administration

Buchanan’s Life Sciences Team

• Antitrust and Trade Regulation ••

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Christopher L. North, Ph.D. S. Lloyd Smith regulatory framework of the United States and that of the foreign countries to determine the Alexandria, Virginia Alexandria, Virginia feasibility of the proposed agreement. Our lawyers review corporate licensing agreements and 703 838 6511 703 838 6514 decipher the details of issues like taxes, patents, trademarks and other intellectual property christopher.north@bipc.com lloyd.smith@bipc.com rights. Some of the issues we deal with every day have to do with CE marks for medical devices, food ingredient listing and labeling, cosmetic marketing and drug clearances. Samantha L. Southall Shantanu C. Pathak, Ph.D. Reimbursement Philadelphia, Pennsylvania Philadelphia, Pennsylvania We work on a215 daily665 basis3939 with our Federal Government Relations Group to assist 215 our 665efforts 3884in shantanu.pathak@bipc.com samantha.southall@bipc.com the reimbursement realm. We have also assisted clients in dealing with Congressional Oversight investigations and hearings related to a variety of food and drug matters.

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4 Complementary Bases That Express Your Potential

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Our new product Aaronopportunities L. J. Pereiraand market approval services include: Genevieve M. Spires

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New York, Newopportunities. York Newark, New Jersey • Financing new development 212 440 4468 973 424 5612 • Protecting products from unfair competition in the post-approval marketing period. aaron.pereira@bipc.com genevieve.spires@bipc.com • Securing proper payment by third-party payers such as insurance companies, Medicare and Medicaid. Michael S. Powers Duane A. Stewart, III We work with clients to prepare Princeton, New Jerseyand submit: Pittsburgh, Pennsylvania 609 6804 412 562 1622 • NDAs, NADAs and987 ANDAs. michael.powers@bipc.com duane.stewart@bipc.com • BLAs and HCT/P registration and listing.

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• PMAs and 510(k) notifications. Linda Pissott Reig • INDs and IDEs. Newark, New Jersey • Combination973 product 424RFDs. 5618 linda.reig@bipc.com • Product jurisdiction determinations. • Citizen petitions.

From discovery to market, Buchanan’s Life Sciences Team will help you express your potential.

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Theodore M. Sullivan Washington, D.C. 202 452 7992 theodore.sullivan@bipc.com

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Richard G. Salazar Carla J. Vrsansky • Appeals of agency action. Tampa, Florida Pittsburgh, Pennsylvania • Food additive GRAS opinions and petitions. 813 222 1142 412 562 1639 • PDUFA and MDUFMA user fee waivers. richard.salazar@bipc.com carla.vrsansky@bipc.com • Pan-European drug, biological product, and medical device approvals and clearances. Donald V. Scaltrito, Ph.D. • Requests forPatent administrative Todd R. Comments Walters Agent hearings Comments to FDA administrative proceedings on guidanceAlexandria, documents and proposed legislation. Alexandria, Virginia Virginia 703 838 6556 703 838 7571 todd.walters@bipc.com donald.scaltrito@bipc.com

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Howard D. Scher Philadelphia, Pennsylvania 215 665 3920 howard.scher@bipc.com Stephany G. Small, Ph.D. Patent Agent Wilmington, Delaware 302 552 4247 stephany.small@bipc.com

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Mark M. Yacura Washington, D.C. 202 452 7949 mark.yacura@bipc.com (continued)

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Food and Drug Administration Group (continued from previous page)

Our regulatory compliance and enforcement assistance includes: • Administrative proceedings and hearings at both the FDA and DEA. • Regulatory correspondence and compliance actions calling for client response and/or corrective action. • Domestic and foreign inspections and audits. • Import detentions. • Administrative and judicial enforcement actions. • Civil actions like product seizures, injunctive proceedings, consent decrees and civil monetary penalties. • Criminal actions, both corporate and individual. • Clinical trial and bioresearch monitoring actions, including disqualification proceedings. • Adverse event, counterfeiting and product deviation reports and actions. • Product recalls. • Product shortage issues. • Government health fraud investigations. • Congressional hearings and investigations. • Court actions by the government or by private parties, such as actions involving trade practices, product advertising, patent enforcement or contract disputes.

We’re Bookish Buchanan’s FDA Group has experience with Orange and Green Book issues and is working with clients on, as well as monitoring closely, developments with the new Purple Book for biologics.

Orange Book Our Orange Book experience includes creating unique listings for products and handling postapproval listing of patents. We guide clients on the nuances between ANDAs and Section 505(b) (2)/paper NDAs. We also have experience with first-to-file ANDA refuse-to-receive issues.

Green Book Our team helped to establish the Green Book, and we have worked with the Center for Veterinary Medicine on its evolution. Our team has animal drug listing experience and can assist you through all phases of the process.

Purple Book We have advised a number of clients on issues relating to listing biosimilar and interchangeable biological products licensed by FDA by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). We have worked with clients to obtain exclusivities for complex biologics and have obtained market exclusivity for orphan drugs and pediatric drugs.

Antitrust and Trade • Antitrust and Trade Regulation Regulation

Buchanan’s Life Sciences Team

• Food and Drug Administration

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Christopher L. North, Ph.D. S. Lloyd Smith Alexandria, Virginia Alexandria, Virginia Buchanan’s703 Antitrust and Trade Regulation Group provides703 comprehensive 838 6511 838 6514 legal services that help life sciences clients achieve their business goals christopher.north@bipc.com lloyd.smith@bipc.com

4 Complementary Bases That Express Your Potential

in today’s challenging life sciences industry. We represent clients in nearly all types ofShantanu antitrust matters, from antitrust compliance andSamantha counseling L.to Southall C. Pathak, Ph.D. antitrust issues in the merger, acquisition and collaborationPhiladelphia, contexts, toPennsylvania Philadelphia, Pennsylvania 215 665 3939 215 665 government and regulatory investigations, to complex antitrust jury3884 trials shantanu.pathak@bipc.com samantha.southall@bipc.com with many millions of dollars at stake. Buchanan’s Antitrust and Trade Regulation Group complements Buchanan’s IP and FDA groups to advise Aaron L. J. Pereira Genevieve life sciences companies on key antitrust-specific issues. Members of M. Spires York, New Newark, New Buchanan’sNew Antitrust andYork Trade Regulation Group provide guidance withJersey 212 440 4468 973 424 5612 regard to Hatch-Waxman, settlement, pay-for-delay/reverse payment aaron.pereira@bipc.com genevieve.spires@bipc.com and sham litigation issues. We also assist clients in complying with the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 Michael S. Powers Duane A. Stewart, III (MMA) and the Hart-Scott-Rodino (HSR) Act.

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From discovery to market, Buchanan’s Life Sciences Team will help you express your potential.

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Princeton, New Jersey 609 987 6804 michael.powers@bipc.com

Pittsburgh, Pennsylvania 412 562 1622 duane.stewart@bipc.com

Key Focus Areas Include:

Hatch-Waxman (Paragraph IV) Litigation Assistance

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Linda Pissott Reig Theodore M. Sullivan As clients consider whether to initiate a Paragraph IV litigation, Buchanan advises on the benefits Newark, New Jersey Washington, D.C. and drawbacks of filing the litigation from an antitrust perspective. Our attorneys also advise 973 424 5618 202 452 7992 on non-litigation options, such as manufacturing or distribution agreements, which may offer linda.reig@bipc.com theodore.sullivan@bipc.com a better resolution in certain contexts. After a Paragraph IV case begins, Buchanan can advise on how to settle cases given current antitrust-related decisions, if settlement is in the best Carla J. Vrsansky interest and isRichard desired byG. theSalazar client. Buchanan has experience in dealing with the FTC; the Tampa, Florida Pittsburgh, Pennsylvania Antitrust Division of the DOJ; state attorneys general; and private parties, such as wholesalers, 813 222 1142 412 562 1639 distributors, retailers, pharmacy benefit managers and end consumers. richard.salazar@bipc.com carla.vrsansky@bipc.com

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Traditional Litigation Donald V. Scaltrito, Ph.D.

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Buchanan’s Antitrust Trade Regulation Group has experience in litigatingTodd antitrust claims or R. Walters Patentand Agent counter-claimsAlexandria, and/or patent misuse affirmative defenses in the life sciences area. As seasoned Alexandria, Virginia Virginia trial attorneys,703 we take aggressive but strategic approach to handling complex class-action 703 838 6556 838an 7571 and individualdonald.scaltrito@bipc.com litigant antitrust cases. For example, we have litigated national class-action todd.walters@bipc.com conspiracy lawsuits brought by direct and indirect purchasers in the pharmaceutical industry, including acting as co-counsel in the defense of Caremark RX, Inc., a pharmacy benefits Mark M. Yacura Howard D. Scher manager, named as a defendant in In re Pharmacy Benefits Managers Antitrust Litigation. Washington, D.C. Philadelphia, Pennsylvania Our attorneys also have experience in defending against patent misuse claims in ITC 202 452 7949 215 665 3920 administrativehoward.scher@bipc.com hearings. mark.yacura@bipc.com

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Stephany G. Small, Ph.D. Patent Agent Wilmington, Delaware 302 552 4247 stephany.small@bipc.com

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Antitrust and Trade Regulation (continued from previous page)

Mergers, Acquisitions and Affiliations Working in conjunction with our team of FDA, IP and corporate attorneys, our Antitrust and Trade Regulation Group has significant experience handling the range of antitrust issues that arise out of mergers and acquisitions, joint ventures, collaborations and other forms of affiliation, including purchasing/selling single drug products, NDAs or ANDAs, and entire companies. Buchanan’s Antitrust and Trade Regulation Group has experience advising on and filing these pre-merger notifications required by the HSR Act. We work with clients to determine if a filing is necessary and, if so, assist our clients in the filing.

Buchanan’s Life Sciences Team Practice Area Key

• Intellecual Property Procurement •

Sarah Abshear San Diego, California 619 685 1981 sarah.abshear@bipc.com

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Edward John Allera Washington, D.C. 202 452 7985 edward.allera@bipc.com

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Carrie G. Amezcua Washington, D.C. 202 452 7953 carrie.amezcua@bipc.com

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Mackenzie A. Baird Pittsburgh, Pennsylvania 412 562 1825 mackenzie.baird@bipc.com

• Intellectual Property Enforcement •

James M. Becker Philadelphia, Pennsylvania 215 665 5366 james.becker@bipc.com Barbara A. Binzak Blumenfeld, Ph.D. Washington, D.C. 202 452 7906 barbara.binzak@bipc.com

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Steven E. Bizar Philadelphia, Pennsylvania 215 665 3826 steven.bizar@bipc.com Travis W. Bliss, Ph.D. Wilmington, Delaware 302 552 4201 travis.bliss@bipc.com

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• Food and Drug Administration

Buchanan’s Life Sciences Team

• Antitrust and Trade Regulation ••

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Christopher L. North, Ph.D. S. Lloyd Smith Alexandria, Virginia Alexandria, Virginia We provide ongoing advice to our clients about trade associations, joint ventures, collaborations, 703 838 6511 703 838 6514 and antitrust and life science compliance issues. Our antitrust assistance has also included christopher.north@bipc.com lloyd.smith@bipc.com advising clients on distribution, licensing, non-compete and exclusivity issues. Our approach of becoming fully knowledgeable of our clients’ business and industry leads Buchanan to be L. Southall Pathak, Ph.D. a trusted part Shantanu of the client’sC. team, providing advice on both day-to-day and Samantha major antitrustPhiladelphia, Pennsylvania Philadelphia, related business matters. Buchanan’s Antitrust and Trade Regulation Group’s knowledge of Pennsylvania the 665 3939 215that 665furthers 3884 the intersection of215 life sciences and antitrust allows us to efficiently provide advice shantanu.pathak@bipc.com samantha.southall@bipc.com goals of our life sciences clients.

Counseling and Compliance Programs

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• Newark, New Jersey

From discovery to market, Buchanan’s Life Sciences Team will help you express your potential.

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Duane A. Stewart, III Pittsburgh, Pennsylvania 412 562 1622 duane.stewart@bipc.com

• Antitrust and Trade Regulation Theodore M. Sullivan

973 424 5618 linda.reig@bipc.com Travis D. Boone Alexandria, Virginia 703 299 6932 Richard G. Salazar travis.boone@bipc.com Tampa, Florida 813 222 1142 richard.salazar@bipc.com Thomas G. Buchanan Pittsburgh, Pennsylvania Donald V. Scaltrito, Ph.D. 412 562 1380 Patent Agent thomas.buchanan@bipc.com Alexandria, Virginia 703 838 7571 donald.scaltrito@bipc.com Nicholas Chidiac Alexandria, Virginia 703 838 6505 Howard D. Scher Nicholas.chidiac@bipc.com Philadelphia, Pennsylvania 215 665 3920 howard.scher@bipc.com Craig G. Cochenour, R.Ph. Pittsburgh, Pennsylvania Stephany G. Small, Ph.D. 412 562 3978 Patent Agent craig.cochenour@bipc.com Wilmington, Delaware 302 552 4247 stephany.small@bipc.com

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Genevieve M. Spires Newark, New Jersey 973 424 5612 genevieve.spires@bipc.com

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Administration • Food and DrugLinda Pissott Reig

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Aaron L. J. Pereira New York, New York 212 440 4468 aaron.pereira@bipc.com

Michael S. Powers Princeton, New Jersey 609 987 6804 michael.powers@bipc.com

4 Complementary Bases That Express Your Potential

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Washington, D.C. 202 452 7992 theodore.sullivan@bipc.com Michael L. Dever Pittsburgh, Pennsylvania 412 562 1637 Carla J. Vrsansky michael.dever@bipc.com Pittsburgh, Pennsylvania 412 562 1639 carla.vrsansky@bipc.com Erin M. Dunston Alexandria, Virginia 703 838 6645 Todd R. Walters erin.dunston@bipc.com Alexandria, Virginia 703 838 6556 todd.walters@bipc.com Matthew J. Feeley Miami, Florida 305 347 5794 Mark M. Yacura matthew.feeley@bipc.com Washington, D.C. 202 452 7949 mark.yacura@bipc.com Ralph G. Fischer Pittsburgh, Pennsylvania 412 392 2121 Alfred W. Zaher ralph.fischer@bipc.com Philadelphia, Pennsylvania 215 665 3880 alfred.zaher@bipc.com

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Buchanan’s Life Sciences Team Practice Area Key

• Intellecual Property Procurement •

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Holly M. Ford Alexandria, Virginia 703 838 6631 holly.ford@bipc.com

Roger H. Lee Alexandria, Virginia 703 838 6545 roger.lee@bipc.com

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Rudolph Garcia Philadelphia, Pennsylvania 215 665 3843 rudolph.garcia@bipc.com

Fang Liu, Ph.D. Alexandria, Virginia 703 838 6686 fang.liu@bipc.com

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Christine M. Hansen Wilmington, Delaware 302 552 4240 christine.hansen@bipc.com

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Philip L. Hirschhorn New York, New York 212 440 4470 philip.hirschhorn@bipc.com

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Bryce J. Maynard Alexandria, Virginia 703 838 6625 bryce.maynard@bipc.com Benjamin F. McAnaney Philadelphia, Pennsylvania 215 665 5368 benjamin.mcananey@bipc.com

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Bassam N. Ibrahim Alexandria, Virginia 703 838 6584 bassam.ibrahim@bipc.com

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Gretchen L. Jankowski Pittsburgh, Pennsylvania 412 562 1417 gretchen.jankowski@bipc.com

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Thomas P. Manning Philadelphia, Pennsylvania 215 665 3847 thomas.manning@bipc.com

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Victoria Bechtold Kush Pittsburgh, Pennsylvania 412 562 1694 victoria.kush@bipc.com

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Shawn Li, Ph.D. Philadelphia, Pennsylvania 215 665 3877 Shawn.li@bipc.com

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William A. Garvin Washington, D.C. 202 452 5471 william.garvin@bipc.com

Tina Hu-Rodgers Washington, D.C. 202 452 7308 tina.hu@bipc.com

• Intellectual Property Enforcement

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Robert G. Mukai Alexandria, Virginia 703 838 6574 robert.mukai@bipc.com

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Mythili Nadella, Ph.D. Alexandria, Virginia 703 299 6927 mythili.nadella@bipc.com

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Wendelynne J. Newton Pittsburgh, Pennsylvania 412 562 8932 wendelynne.newton@bipc.com

• Food and Drug Administration

Buchanan’s Life Sciences Team

• Antitrust and Trade Regulation

Christopher L. North, Ph.D. Alexandria, Virginia 703 838 6511 christopher.north@bipc.com Shantanu C. Pathak, Ph.D. Philadelphia, Pennsylvania 215 665 3939 shantanu.pathak@bipc.com

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Duane A. Stewart, III Pittsburgh, Pennsylvania 412 562 1622 duane.stewart@bipc.com

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Theodore M. Sullivan Washington, D.C. 202 452 7992 theodore.sullivan@bipc.com

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Richard G. Salazar Tampa, Florida 813 222 1142 richard.salazar@bipc.com

Carla J. Vrsansky Pittsburgh, Pennsylvania 412 562 1639 carla.vrsansky@bipc.com

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Todd R. Walters Alexandria, Virginia 703 838 6556 todd.walters@bipc.com

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Mark M. Yacura Washington, D.C. 202 452 7949 mark.yacura@bipc.com

Howard D. Scher Philadelphia, Pennsylvania 215 665 3920 howard.scher@bipc.com Stephany G. Small, Ph.D. Patent Agent Wilmington, Delaware 302 552 4247 stephany.small@bipc.com

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Samantha L. Southall Philadelphia, Pennsylvania 215 665 3884 samantha.southall@bipc.com Genevieve M. Spires Newark, New Jersey 973 424 5612 genevieve.spires@bipc.com

Michael S. Powers Princeton, New Jersey 609 987 6804 michael.powers@bipc.com

Donald V. Scaltrito, Ph.D. Patent Agent Alexandria, Virginia 703 838 7571 donald.scaltrito@bipc.com

4 Complementary Bases That Express Your Potential

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Aaron L. J. Pereira New York, New York 212 440 4468 aaron.pereira@bipc.com

Linda Pissott Reig Newark, New Jersey 973 424 5618 linda.reig@bipc.com

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S. Lloyd Smith Alexandria, Virginia 703 838 6514 lloyd.smith@bipc.com

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