The Life Sciences at Frommer Lawrence & Haug LLP

Though much has changed since we opened our doors almost 14 years ago, what remains the same is our unwavering commitment to excellence, innovation, and integrity in servicing all aspects of our clients’ needs in the life sciences. Our personalized, strategic guidance has been a hallmark in how we address our clients’ needs and objectives. This individualized approach ensures that the full potential of our clients’ work is achieved, while future problems are circumvented. We measure our success by the success of the individuals and companies we serve. Our experience, perseverance, and vision allow us to provide innovative, strategic legal solutions that lead directly to expanded business opportunities in technologies within the life science industry. Frommer Lawrence & Haug LLP’s commitment to delivering the highest level of service allows clients to focus on their business and to execute on creative brand ideas, as we guide them through the entire life cycle of their products and services. In the increasingly competitive world of life sciences, our depth of experience coupled with our technical and scientific expertise make us the preferred resource to handle all legal matters. Whether you are a small startup, a research institution, or a major corporation, we invite you to consider how our distinctive approach to the law and life sciences can help you realize your personal and professional goals. Best regards, Sandra Kuzmich, Ph.D. Partner

Sandra Kuzmich, Ph.D., is a partner in the New York office of FLH and leads the firm’s life science practice. She focuses her practice in the areas of strategic intellectual property counseling and pharmaceutical product life cycle management. Dr. Kuzmich is particularly experienced in developing and managing diverse patent portfolios in view of a client’s immediate and long-term business objectives.

Our diverse expertise allows us to help ensure that the value of our clients’ products is maximized throughout their life cycle.

Life Cycle Management

With experience in intellectual property, regulatory, and antitrust law, FLH successfully counsels and guides its clients through managing the entire life cycle of their life science products. Leveraging our scientific and legal know-how, we implement distinct platforms that manage the unique needs of our individual clients. Many of our attorneys, patent agents, and scientific advisors hold advanced technical degrees in the life sciences. We routinely work directly with scientists and/or inventors to safeguard all possible aspects of their products by obtaining patents, advising on their portfolios, and discussing secondgeneration technologies. Our regulatory expertise guides clients through the process of bringing products, such as pharmaceuticals and biologics, to market. Our wide array of services include pre-market approval applications, product claims and labeling, good manufacturing practice requirements, FDA inspections, and prescription drug user fees, to name a few. Our experience in licensing and transactions guides clients through developing relationships and making agreements that will further advance their businesses. Examples include handling licenses for intellectual property or other assets, developing partnerships with other corporations or university technology transfer offices, and negotiating agreements with suppliers. We are well-versed in both protecting products and asserting intellectual property against adversaries. Our knowledge of both the law and life sciences equips us with the tools needed to succeed in litigations, and our vast and successful track record is a testament to the strength of our firm. FLH understands that the life cycle of products is continuous and dynamic, and not a succession of distinct steps. Our creative and collaborative approach provides our clients with the guidance and expertise that they need, when they need it.

Patent Prosecution

FLH is committed to securing the strongest patents possible for our clients. From developing patent portfolios for small biotechnology startups to supervising the management of multiple patent families for large multinational corporations, our dedicated and skilled attorneys, patent agents, and scientific advisors bring a multi-angled approach to the protection of our clients’ life science technologies. FLH helps safeguard proprietary technology in the U.S. and abroad, prosecuting patents before the U.S. Patent and Trademark Office, as well as filing patent applications globally under the Patent Cooperation Treaty (PCT). We have excellent relationships with leading global intellectual property firms and are frequently sought after to assist in managing global patent portfolios. Our attorneys, patent agents, and scientific advisors, many of whom hold advanced technical degrees, handle all aspects of patent prosecution. Our experience includes pre-patent filing analysis, accelerated patent examinations, reissues, and reexaminations, as well as patent opposition proceedings with foreign counsel. Our biotechnology patent prosecution practice extends across a number of areas, including molecular biology, cellular biology, transgenic animals, virology, immunology, genomics, proteomics, and biomarkers. In addition, we handle the prosecution for pharmaceutical and medical device technologies, such as small molecules, pharmaceutical formulations, neural implant devices, tissue transplant technologies, and bioinformatics. At FLH, we work closely with each of our clients to further their commercial objectives and to develop patent strategies that can maximize the value of their intellectual property estate. Our success is directly linked to that of the individuals and companies we serve. And, our depth of experience and scientific expertise make us a preferred resource to handle all patent matters.

The U.S. Patent and Trademark Office offers an accelerated examination procedure that allows an application to advance out of turn for examination. This procedure may be useful for inventions that must be patented as quickly as possible, e.g., to protect marketed products, to rapidly build a portfolio for potential investors, etc. FLH has a proven track record of successfully preparing accelerated applications and is adept in prosecuting these applications in compliance with the complex accelerated examination procedures. As a result, FLH has been successful in obtaining patents using the accelerated examination program, leading to issued patents in as little as five months from the filing date of the application.

Our team of dedicated and skilled attorneys, patent agents, and scientific advisors are committed to securing the strongest patents for our clients, both in the United States and around the world.

We have the experience and expertise to help our clients form and maintain collaborative relationships that are often necessary in the life science industry.

Licensing & Transactions

Recognizing that the growth and development of life science technologies often require collaborative agreements, FLH offers clients a vast array of licensing and transaction services to help grow their businesses and minimize the potential for costly risks. Our lawyers are experienced at handling agreements pertaining to all stages in the development of a life science product, from collaborations during the inception of the technology, and joint ventures or licensing for clinical development, through strategic alliances and partnerships for distribution and marketing. We help structure agreements that meet our clients’ present needs while ensuring that they are strategically positioned to benefit from future opportunities. Our attorneys have expertise in due diligence, deal architecture, negotiations, and counseling associated with a broad variety of transactions. We are skilled in licensing intellectual property rights for technology transfer offices of various universities, and at maximizing the value that universities and research institutions are able to obtain in exploiting patents, know-how, and technical rights throughout the world. We also have years of experience in protecting the transactional interests of clients, that range from large pharmaceutical corporations to first innovators, and from brand companies to generic developers. For our large clients, we are well-versed in analyzing the costs and benefits of forming collaborations, for example, by evaluating the other parties’ intellectual property for invalidity or infringement issues, or by analyzing the other parties’ progress towards regulatory approval. For our first innovator clients, we are adept at strategizing how to present their products and intellectual property to potential licensors, buyers, investors, etc., and can work with our clients in addressing questions and issues directed at their work. As life science products continue to become the result of collaborative efforts, FLH supports its clients in preparing agreements and executing transactions to further their overall success.

FDA/Regulatory

Navigating the regulatory issues related to bringing a life science product to market necessitates a thorough understanding of the relevant FDA/ Regulatory requirements. At FLH, our attorneys offer over 30 years of private practice experience with FDA/Regulatory matters, giving us the ability to offer counsel on FDAregulated products such as food, drugs, biologics and biosimilars, medical devices, cosmetics, dietary supplements, and tobacco products. Our experience includes pre-market approval applications; product labeling, advertising, and promotion; product safety issues, such as risk evaluation and mitigation strategies (REMS); good manufacturing practice requirements; life cycle management; and regulation pertaining to imports and exports. Our FDA/Regulatory attorneys represent a diverse assortment of life science companies, and work closely with FLH’s Hatch-Waxman litigation and life cycle management practices to handle Paragraph IV Certifications and Notice Letters, bioequivalence and other requirements for 505(b)(2) NDAs and ANDAs, licensing and corporate transactions, and antitrust considerations. We are experienced in drafting Citizen Petitions, commenting on proposed FDA regulations, bringing court challenges to FDA rules and statutory interpretations, responding to FDA warning letters, addressing FDA inspections and recalls, and representing companies in seizures, criminal proceedings, injunctions, and appeals. Many of our FDA/Regulatory attorneys have worked in the FDA’s Office of the Commissioner, Office of Chief Counsel, and the Center for Drug Evaluation and Research. As a result, FLH enjoys an intimate knowledge of agency processes and procedures, and can offer valuable insights on FDA policies that are unavailable elsewhere. The depth of our experience within our FDA/Regulatory practice, coupled with our excellent service and verified track record, makes FLH a proven leader in FDA/Regulatory matters.

With over 30 years of private practice experience in FDA/Regulatory matters, our attorneys have an intimate understanding of the requirements relevant to bringing a life science product to market.

FLH’s technical expertise, aggressive presentation, and ability to project and prioritize at every juncture in litigation have yielded critical victories for our life science clients.

Trial Advocacy

Our technical expertise, aggressive presentation, and ability to project and prioritize at every juncture in litigation has brought our diverse international clientele significant and enduring success in the courtroom. We have an accomplished track record of creative lawyering, “outside-the-box” thinking, and assertive litigating that has consistently helped our life science clients to identify and resolve litigation exposure. Industry leaders throughout the world turn to us to handle challenging disputes, many of these critical to sustaining entire businesses. We pursue litigation with a mind towards our clients’ overall business goals, considering the risks and potential rewards before moving forward. We have leveraged the positions and arguments developed through litigation to achieve a number of settlements and licenses with beneficial terms for our clients. FLH’s litigation practice was built by experienced litigators with substantial courtroom success. We know the courts and the players, and judges acknowledge the quality of our writing and courtroom submissions. We also excel at identifying and asserting clear and cogent arguments that emerge from a complex set of facts and address the core issues. Our partners, associates, and scientific advisors couple advanced life science degrees and significant pharmaceutical experience with litigation skills to ensure that all scientific issues are understood fully throughout the litigation process. FLH is poised to respond dynamically to rapidly changing technologies that are circumscribed by continuous developments in the relevant case law, statutes, and regulations. Our strategic and collaborative approach has benefited our life science clients immensely. We understand precisely when to litigate, when and how to negotiate attractive settlements, how to manage regulatory processes, what further litigation threats are likely, and ultimately, what litigation strategy will work to meet a client’s competitive business needs long after a litigation is resolved. We personalize this expertise for each of our clients, and are proud to be recognized as one of the most respected and successful litigators in our field. This combination of “real-world” experience and scientific expertise, accompanied by unparalleled client service and legal success, makes FLH uniquely qualified to address life science litigation in an increasingly complex industry and global legal environment.

Appellate

As uniquely qualified experts in appellate litigation, FLH leverages its full suite of knowledge to represent clients on federal issues in patent, trademark, and antitrust law. And, as experts in discovery, legal analysis, brief writing, and oral arguments, FLH provides authoritative counsel to our clients in the life sciences. FLH is able to substantially increase the likelihood of its clients’ success by bringing them an intimate knowledge of the Court of Appeals for the Federal Circuit and the appellate bar. We provide legal advice and counseling on the processes of appellate law and help preserve points for appeal. In addition, we bring to the table an interdisciplinary background of life science and the law, which includes a keen understanding of the complexities surrounding appellate litigation. Our experience and expertise allow us to identify the most important and relevant facts and arguments, and present them to appellate courts in a compelling and persuasive manner. Having frequently appeared before the U.S. Courts of Appeals for the Federal Circuit, as well as before circuit courts of appeals and state appellate courts, our attorneys are often asked to support and assist trial counsel and clients with pre-trial motions, post-trial motions, interlocutory appeals, and writ petitions. With extensive expertise in appellate procedures, combined with advanced degrees in the life sciences, FLH is the best choice to handle your appellate needs.

Our interdisciplinary background in the life sciences and the law allow us to identify the most important and relevant facts and arguments, and present them to appellate courts in a compelling and persuasive manner.

FLH’s seasoned antitrust attorneys have developed a particularized expertise in guiding clients in the life sciences through a broad array of antitrust challenges.

Antitrust

Developing and marketing a life science product – be it a small molecule, biologic, or medical device – can sometimes involve antitrust matters. With significant experience advising businesses ranging from major pharmaceutical companies to biotech startups, FLH’s seasoned antitrust practitioners help clients recognize and mitigate their antitrust risk and exposure in their day-to-day operations. This includes providing counsel on life science product distribution and pricing, joint venture and competitor collaboration arrangements, and participation and membership in trade associations. We also successfully represent both plaintiffs and defendants in complex, multi-jurisdictional antitrust cases involving allegations of horizontal price fixing, market allocation, boycotts, resale price maintenance, price discrimination, tying, and monopolization, to name a few. The antitrust practice at FLH serves all aspects of our clients’ competition needs, including merger analysis, product pricing, life cycle management, antitrust counterclaims in patent litigation, and negotiating and defending settlements of Hatch-Waxman patent cases. Our antitrust attorneys regularly work hand-in-hand with our firm’s patent attorneys and scientific advisors to provide clients with a well-rounded understanding of the antitrust implications of their particular intellectual property acquisition, settlement, license, or joint venture arrangement. FLH’s antitrust attorneys have over thirty years of experience in government and private practice, covering the full breadth of competition issues. We have developed particular expertise representing drug manufacturers in their settlements of Hatch-Waxman litigations. We also have a proven track record representing clients before the Federal Trade Commission and Antitrust Division of the Department of Justice. By drawing upon our patent prosecution and litigation expertise, in-house scientific advisors, and our regulatory and transactional knowledge base, FLH is uniquely positioned to handle our clients’ antitrust needs.

Trademarks & Copyrights

Our collaborative approach relies on routine client interactions and results in an array of services that creates a valuable brand protection strategy for our clients’ life science products and services. FLH’s attorneys work closely with clients early in the trademark selection process to perform clearance searches and assist in the selection of strong and legally enforceable trademarks. We develop a thorough understanding of the product or service and future opportunities in the life sciences and related markets. We manage our clients’ domestic and international portfolios and devise strategies for effective worldwide brand protection. As experts in protecting our clients’ rights through administrative procedures and through litigation, we initiate proceedings at the U.S. Patent and Trademark Office, the federal courts, and before the International Trade Commission. We are skilled in crafting settlements that protect our clients’ rights and extract value. When competitors engage in false or misleading advertising, FLH promptly addresses their misrepresentations to obtain either voluntary cessation of the advertising, corrective advertising, and/or injunctive relief and damages for any injury sustained to our clients’ reputation or sales. In addition, we have extensive experience in valuation and due diligence with regard to trademark and copyright portfolios. Portfolio strength can be important when businesses are bought and sold, and we are proven leaders in maximizing financial value at completion of the transaction. In an age where intellectual property rights contribute increasingly to a company’s balance sheet, we are able to protect our clients’ valuable intangible assets.

FLH’s attorneys develop a thorough understanding of our clients’ products and services and future market opportunities so they can focus on their business and execute their creative brand ideas.

BROCHURE DESIgN: ROSS CULBERT & LAVERY, NEW YORK CITY

New York 745 Fifth Avenue New York, New York 10151 Tel: (212) 588-0800 Fax: (212) 588-0500 Washington, DC 1667 K Street, NW Washington, District of Columbia 20006 Tel: (202) 292-1530 Fax: (202) 292-1531 Seattle 1191 2nd Avenue - Suite 2000 Seattle, Washington 98101 Tel: (206) 336-5690 Fax: (206) 336-5691 Tokyo 1-2-9 Nishi-Shimbashi, 14th Floor Hibiya Central Building Minato-Ku Tokyo, 105-0003 Tel: 03-5532-7278 Fax: 03-5532-7373

www.flhlaw.com