SUMMER 2013

Please join us for a wine tasting at First Crush during the 2014 JPMorgan Healthcare Conference and the 7th Annual OneMedForum San Francisco

Wine Tasting, Networking, Cocktails and Hors d'oeuvres

Monday, January 13, 2014 6:00 p.m. - 9:00 p.m.

First Crush 101 Cyril Magnin Street | San Francisco, CA 94102 Tel: 415.982.7874 RSVP TO GTRSVP@GTLAW.COM

FDA GUIDANCE FOR INDUSTRY AND FDA STAFF: MOBILE MEDICAL APPLICATIONS By Nancy Taylor, GT Washington, D.C. Office

GREENBERG TRAURIG WINS LANDMARK ORGANIC FOOD PRODUCT COURT OF APPEAL CASE IN CALIFORNIA By Mark D. Kemple, GT Los Angeles Office; Angela Diesch, GT Sacramento Office

REGULATION OF INGREDIENTS: A NOVEL APPROACH By Justin Prochnow, GT Denver Office

FDA DEFINES “GLUTEN-FREE” By Miki Kolton, GT Washington, D.C. Office

IN THIS ISSUE

UPCOMING EVENT FALL 2013 / WINTER 2014

NEW HSR RULES WILL REQUIRE MORE FILINGS FOR PHARMACEUTICAL PATENT TRANSFERS: INCREASED REVIEW RAISES IMPORTANCE OF VALUATION By Mary Marks, GT New York Office

CHINA’S PATENT RE-EXAMINATION BOARD SAYS PHARMACEUTICAL SALTS NOT PATENTABLE OVER PURE COMPOUNDS By Weisun Rao, Ph.D., GT Shanghai/ Chicago Office

THE EU SEEKS STRENGTHENING OF SAFE HARBOR RULES By Phillipe Bruno, GT Washington, D.C. Office

DUTCH DATA PROTECTION REGIME TO BE ENHANCED BY PROPOSED MANDATORY DATA BREACH NOTIFICATIONS IN PARALLEL WITH EU EFFORTS TO HARMONIZE NOTIFICATION OF PERSONAL DATA BREACHES By Emilie van Hasselt, GT Amsterdam Office

THE HIPAA OMNIBUS RULE: COVERED ENTITY LIABILITY FOR BUSINESS ASSOCIATE ACTIONS By Tricia Asaro and Benjamin Friedman, GT Albany Office; Miki Kolton, GT Washington, D.C. Office

NEW JERSEY’S NEW SOCIAL MEDIA LAW BLOCKS EMPLOYERS’ PRYING EYES By Wendy Lario, GT New Jersey Office

FACEBOOK FUNCTIONALITY NOW FAIR GAME FOR PROMOTION MARKETERS By Ed Chansky, GT Las Vegas Office

NEW DEVELOPMENTS IN INTERNATIONAL STANDARDS ON OCCUPATIONAL HEALTH AND SAFETY, COMPLIANCE PROGRAMS, AND ANTI-BRIBERY MANAGEMENT SYSTEMS By Christopher Bell, GT Houston Office

GT IN THE INDUSTRY

FDA Guidance for Industry and FDA Staff: Mobile Medical Applications

By Nancy Taylor, GT Washington, D.C. Office

On September 25, 2013, the U.S. Food and Drug Administration (the "FDA") released final guidance on the regulatory requirements regarding the introduction of mobile medical applications into the marketplace (the "Final Guidance"). The purpose of the Final Guidance and its Appendices is to assist manufacturers with determining if a product is a mobile medical app, and if so, the FDA’s expectations for that product. The Final Guidance provides lengthy definitions of a number of key terms, including what constitutes a “mobile platform”, a “mobile application,” and a “regulated medical device”. Of major importance, mobile applications can transform a mobile platform into a regulated medical device by using attachments, display screens, sensors, or other such methods. While the FDA intends to apply its regulatory oversight to only a subset of mobile medical applications, included among those mobile medical applications that are subject to FDA regulatory oversight are: 1. Mobile applications that are an extension of one or more medical devices by connecting to such device(s)

for purposes of controlling the device(s) or displaying, storing, analyzing, or transmitting patient-specific medical device data.

2. Mobile applications that transform a mobile platform into a regulated medical device by using attachments, display screens, or sensors or by including functionalities similar to those of currently regulated medical devices.

3. Mobile applications that become a regulated medical device (software) by performing patient-specific analysis and providing patient-specific diagnosis.

To read more about FDA regulatory guidance and oversight of mobile medical applications, and the full GT Alert on this matter, [CLICK HERE].

FDA GUIDANCE - MOBILE MEDICAL TECHNOLOGY

Greenberg Traurig Wins Landmark Organic Food Product Court of Appeal Case in California

By Mark D. Kemple, GT Los Angeles Office; Angela Diesch, GT Sacramento Office

In a case of first impression with enormous national implications for the food industry, the California Court of Appeal, Second Appellate District, ruled on December 23, 2013, that state law consumer actions challenging certified organic growers’ labeling of food products as “organic” are preempted by federal law, and cannot be maintained. Greenberg Traurig LLP represented HerbThyme Farm Inc. in an alleged mislabeling case, Quesada v. HerbThyme Farms, Inc., in which the plaintiff brought a class action lawsuit alleging that the defendant mixed conventional herbs with organic herbs, and then improperly labeled and sold the mixture as “organic.” The plaintiff alleged that this violated California’s false advertising laws, Consumer Legal Remedies Act, and unfair competition laws.

HerbThyme Farms, Inc., a large grower and marketer of herb products, adamantly denied any wrongdoing and argued that such state law claims are preempted in any event by the Federal Organic Foods Production Act of 1990, found at 7 U.S.C. §6501, et seq. (“OFPA”). In addition, it argued the OFPA, in effect, mandates that there be one deciding body or umpire on the question of whether food products are organic – namely the USDA or its state designee – and that the USDA alone may define the zone in which such an “organic” designation may fall. In effect, the plaintiff had sought to replace the OFPA and its implementing regulations, the National Organic Program (“NOP”), with a reasonable consumer standard, and sought to replace the federal umpire or USDA with California state court juries comprised of individual consumers.

HerbThyme Farms, Inc. argued that if individual consumers could second-guess the USDA’s “organic” call through state law consumer actions, industry players would hesitate stepping to the plate. Further, the purpose of the OFPA – attaining a vibrant organic industry in which producers and consumers could rely on a nationwide unifying “organic” standard – would be defeated. The California Court of Appeal’s decision (which was issued after full and extended briefing and oral argument by the parties) agreed with the defendant as the Court of Appeal ruled that a private right of action under state consumer laws is contrary to the clear congressional intent for federal regulation of standards for “organic” food products and their labeling, and that such actions are precluded and pre-empted by Federal law. The Court of Appeal’s decision supports uniform organic standards regulated by Federal policies, without the risk of private enforcement with subjective opinions of what it means to be organic.

Greenberg Traurig litigation shareholder Mark D. Kemple led the representation of HerbThyme Farms, Inc. with litigation associate Angela Diesch. To read the full Alert, [CLICK HERE] and for the full Press Release, [CLICK HERE].

REGULATION OF FOOD & BEVERAGE LABELING AND INGREDIENTS

Regulation of Ingredients: A Novel Approach

By Justin Prochnow, GT Denver Office

The wide range of consumer food and beverage products and their ingredients has been rapidly expanding, including the growth of very specific categories, such as organic energy drinks, sports nutrition bars, and flavored drink additives. As companies scour the globe for new ingredients, ranging from herbs and botanicals to prebiotics and probiotics, it is critical that these companies be mindful of how such ingredients are likely to be regulated. The regulation of ingredients for conventional foods and beverages versus dietary supplements differ in some important ways that could very well dictate the viability of using certain ingredients and the ultimate classification of the intended product as a conventional food or as a dietary supplement. All ingredients intentionally added to conventional foods or beverages are considered food additives by the US Food and Drug Administration (FDA). Food additives must either be approved through regulation by the FDA as food additives, deemed “generally recognized as safe” or “GRAS”, or otherwise be exempted (such as with color additives). The approved food additives are identified in regulations set forth by the FDA in the Code of Federal Regulations. If an ingredient is not an approved food additive, an ingredient must be GRAS to be legally used in a conventional food or beverage. If an ingredient is not GRAS pursuant to a particular regulation, or if the amount or use of an ingredient is outside the scope of a GRAS regulation, an ingredient may still be legally used in a conventional food or beverage if it can be demonstrated to be GRAS. An ingredient can be demonstrated to be GRAS if it is recognized, among qualified experts, as having been adequately shown through scientific procedures to be safe under the conditions of its intended use. In such situations, a report, often called a “self-affirmed GRAS report”, must be compiled.

Food and beverage companies must be prepared to provide evidence of the GRAS status of an ingredient to the FDA. While there is no specific law mandating that the GRAS report be compiled by a third-party, the objectivity of a company preparing its own self-affirmed GRAS report may be looked at skeptically by the FDA. The costs associated with preparing a thorough, self-affirmed GRAS report, are often at least $40,000 per ingredient, and the costs can run upwards of $75,000 to $100,000 per ingredient. If a product contains multiple ingredients that are not approved food additives or GRAS by regulation, the costs of assembling a self-affirmed GRAS report to legally include several novel ingredients can run into hundreds of thousands of dollars, making the classification of the intended product as a conventional food or beverage a very expensive proposition.

On the flip side, ingredients contained in a “dietary supplement” are regulated differently. The categories of legally permissible dietary supplement ingredients are set forth in the definition of “dietary supplement” found in the federal Food, Drug and Cosmetic Act. Categories of “dietary supplements” include vitamins, minerals, herbs and botanicals, amino acids, dietary substances used to supplement the diet by increasing the total dietary intake, and concentrates, metabolites, constituents or extracts of any ingredients within the above categories. If there is no proof of use as a dietary ingredient prior to October 1993 and the ingredient is not an approved food additive or GRAS, a new dietary ingredient (NDI) notification must be filed with the FDA. The NDI notification must include evidence of safety for the intended use. Historically, companies may have viewed the dietary supplement route as the cheaper alternative to the expenses incurred from one or more self-affirmed GRAS reports, however, with the passage of the Dietary Supplement Good Manufacturing Practices (DS GMPs) and the subsequent enforcement efforts from FDA to enforce the DS GMPs, costs incurred by dietary supplement companies have made the cost comparisons between conventional foods and dietary supplements much closer. To read more about the FDA’s regulation of conventional food and beverage ingredients and dietary supplements, and to read the full Article on this matter, [CLICK HERE].

FDA Defines “Gluten-Free”

By Miki Kolton, GT Washington, D.C. Office

In 2004, the Food Allergen Labeling and Consumer Protection Act of 2004 directed the U.S. Department of Health and Human Services (DHHS) to define and permit the use of the term "gluten-free" in the labeling of foods. On August 5, 2013 the Food and Drug Administration (FDA) published its final rule defining the term "gluten-free" for voluntary use in food labeling. Under the final rule, the “gluten-free” label may be used on food that is either inherently gluten free; or does not contain an ingredient that is a gluten-containing grain or that is derived from a gluten-containing grain provided that gluten in the food ingredient does not contain the presence of 20 parts per million (ppm). The FDA provided clarification that manufacturers are not required to test for gluten to make a gluten-free claim on their food labels, and the final rules offer manufacturers a number of means and methods for ensuring that foods bearing the gluten-free label meet the requirements of the final rule. Manufacturers may choose to use effective quality control tools, such as:

■ Conducting in-house gluten testing of starting ingredients or finished foods; ■ Employing a third-party laboratory to conduct in-house gluten testing; ■ Requesting certificates of gluten analysis from ingredient suppliers; or ■ Participating in a third-party gluten-free certification program.

To read the full GT Alert, and more about the compliance options available to food manufacturers using the “gluten-free” label, [CLICK HERE].

New HSR Rules Will Require More Filings for Pharmaceutical Patent Transfers: Increased Review Raises Importance of Valuation

By Mary Marks, GT New York Office

On November 6, 2013, the Federal Trade Commission (FTC), in consultation with the U.S. Department of Justice, issued final Amendments to the Premerger Notification Rules under the Hart-Scott-Rodino (HSR) Act which formalize and broaden previous unofficial guidance given by FTC Staff regarding the circumstances under which transactions involving the transfer of exclusive rights to a pharmaceutical patent - generally by license - are potentially reportable under the HSR Act. Certain pharmaceutical patent transfers that have not been reportable historically (because the licensor retained manufacturing rights under the patent) will no longer be exempt from the HSR reporting requirements. Given the FTC’s longstanding position on non-exclusive intellectual property licenses, it may come as a surprise to some parties that the HSR Act may apply to their transaction.

Determining the transaction value will now be critical in assessing whether a patent license will require an HSR filing, and patent license valuations will now take on a greater significance in determining whether specific transfer transactions are reportable. Identifying potentially reportable patent license transactions will require analysis of the patent rights transferred and retained, as well as a calculation of the somewhat amorphous acquisition price and fair market value of the rights being transferred. To read the full GT Alert, [CLICK HERE].

PHARMACEUTICAL PATENT TRANSFERS AND PATENT CHALLENGES

China’s Patent Re-Examination Board Says Pharmaceutical Salts Not Patentable Over Pure Compounds

By Weisun Rao, Ph.D., GT Shanghai/ Chicago OfficeS

In July 2013, the Patent Re-Examination Board of China’s State Intellectual Property Office invalidated the Chinese patent of Gilead Sciences, a U.S. biotech company, covering Tenofovir Disoproxil Fumarate (TDF or PMPA), which is the active ingredient in Gilead Sciences’ drug “Viread”. Viread is used for treating HIV, AIDS and hepatitis B. The patent challenger argued that compared to the prior art disclosure (a Czech patent issued in 1985), the active ingredient of Viread (i.e. the fumarate salt) only renders better bioavailability and makes the compound easier to be absorbed, not more. Several years ago the Chinese Patent Re-Examination Board made a similar finding (citing the same grounds) against Pfizer’s Chinese patent on Viagra, however, the Board’s decision was ultimately overturned on appeal by the Beijing Intermediate People’s Court.

To read more about Chinese patent claims, and the full GT Alert, [CLICK HERE].

The EU Seeks Strengthening of Safe Harbor Rules

By Phillipe Bruno, GT Washington, D.C. Office

The European Union (EU) has launched a commission to review the U.S. Department of Commerce’s (DOC) “Safe Harbor” agreement, which is a voluntary program for U.S.-based companies with operations in the EU that transfer personal data across EU borders. EU officials are interested in reviewing the compatibility of the Safe Harbor program with new EU laws on data protection. The EU has raised concerns that the Safe Harbor program may be using “loopholes” to skirt EU data privacy and protection rules. The Safe Harbor program is based on the EU Data Protection Directive, but, as noted by the International Trade Association (ITA), it is limited when national security or defense matters are in question. To read the full GT Alert on this matter, [CLICK HERE]. Dutch Data Protection Regime To Be Enhanced By Proposed Mandatory Data Breach Notifications in Parallel With EU Efforts to Harmonize Notification of Personal Data Breaches

By Emilie van Hasselt, GT Amsterdam Office

The European Commission’s new data breach notification rules became applicable across Europe as of August 25, 2013 for all telecom operators and internet service providers in the EU Member States. In June 2013, the Netherlands introduced a legislative proposal to require mandatory data breach notifications and give the Dutch Data Protection Authority (DPA) the power to impose substantial fines for failure to comply with the new requirements. The proposed Dutch data breach requirements would provide for a stricter regime than most other EU Member States, and will not be limited to the telecom sector, but would apply to all organizations responsible for processing or controlling personal data, including financial institution and public bodies. To read the complete GT Alert on development of Data Protection regulations in the Netherlands and the EU, [CLICK HERE].

DATA TRANSFER, SECURITY AND PRIVACY DEVELOPMENTS - EU AND US

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The HIPAA Omnibus Rule: Covered Entity Liability for Business Associate Actions

By Tricia Asaro and Benjamin Friedman, GT Albany Office; Miki Kolton, GT Washington, D.C. Office

In January 2013, the U.S. Department of Health and Human Services (HHS) issued its new Omnibus regulations that strengthen the privacy and security protections established under the Health Insurance Portability and Accountability Act (HIPAA) and the Health Information Technology for Economic and Clinical Health Act (HITECH). The HIPAA Omnibus Rule implemented important changes to the liability of U.S. “covered entities” under HIPAA (i.e. health care providers, health plans, and health care claims clearinghouses) for the conduct of their contracted service providers that use or disclose protected health information (“business associates”). The Omnibus regulations will have wide-ranging implications for both covered entities and business associates. Business associates themselves may now incur liability for HIPAA violations, and a covered entity can also now be held liable for the acts or omissions of its business associates that are acting as the covered entity’s “agent,” as determined under the federal common law of agency. This agency liability also extends to business associates, which may, in turn, incur liability for the actions or omissions of their subcontractors. To read about the factors which are relevant to HIPAA liability of covered entities, their business associates, and subcontractors, [CLICK HERE].

New Jersey’s New Social Medial Law Blocks Employers’ Prying Eyes

By Wendy Lario, GT New Jersey Office

As increasing numbers of Americans are using social media sites, both on and off the job, many employers are requiring employees to turn over their usernames or passwords for their personal social media accounts in an effort to protect proprietary information or trade secrets of the employer and prevent exposure to legal liabilities. Driven by a desire to protect employee privacy, state governments are increasingly seeking to prevent employers from making such requests. On December 1, 2013, New Jersey joined the growing number of U.S. states that have passed laws to prohibit employers from requiring or requesting current and prospective employees to disclose their social media passwords, and also prohibiting retaliation or discrimination by employers against employees for refusing access to a personal account, reporting violations, and for participating in any investigation or proceeding concerning violation of the new act. To read the full GT Alert on this matter, [CLICK HERE].

SOCIAL MEDIA ISSUES

Facebook Functionality Now Fair Game for Promotion Marketers

By Ed Chansky, GT Las Vegas Office

On August 27, 2013, Facebook materially updated its Promotions Guidelines, and sponsors now have a wider range of choices for administering sweepstakes and contest promotions on Facebook, allowing marketers to use native Facebook functionality (posts, likes, comments, etc.) to generate entries into Sweepstakes and contests. Old Guidelines Under prior Facebook guidelines, a marketer had to use its own software application to administer any sweepstakes or contest, and the use of Facebook features or functionality (such as posting, commenting or liking) was generally prohibited. What Changed While sponsors can continue to use their own applications to administer their promotions, they are no longer required to do so. Instead, for example, they may now use the “like” button to count votes in a contest, or they can now allow Sweepstakes entries to be based on actions such as commenting on a Page or post, clicking “like,” or messaging a page. To read the full GT Alert on this matter, [CLICK HERE].

New Developments in International Standards on Occupational Health and Safety, Compliance Programs, and Anti-Bribery Management Systems

By Christopher Bell, GT Houston Office

The International Organization for Standardization (ISO) creates international standards on a number of topics important to companies operating in the U.S. and abroad, including environmental, occupational safety, compliance, and anti-bribery management systems. ISO standards are important for a number of reasons, and as global compliance standards they are becoming a condition of doing business in many markets. They also influence national and international policy. In the U.S., federal agencies are obligated to take consensus standards into account pursuant to the National Technology Transfer Act, and national requirements based on ISO standards are presumptively valid under World Trade Organization rules in the event they are challenged as non-tariff trade barriers. ISO standards are also influential in regions that do not have an established national counterpart (legal or otherwise) to the subject matter of the standard. The following areas of focus are among the ISO’s ongoing standard reviews and new standard development projects: Standard Development for Compliance Programs. One ISO initiative is to develop ISO standards and criteria for effective compliance and ethics programs, such as those currently addressed in the U.S. by the federal Sentencing Commission. Anti-Bribery Management Systems. The ISO’s Anti-Bribery Management System effort is being led by the UK, based on an existing UK standard that is explicitly aimed at satisfying the defense under the UK Bribery Act of having “adequate procedures” in place to prevent bribery.

ISO INTERNATIONAL STANDARDS

Occupational Health and Safety Management Systems. ISO has launched an effort to create an international Occupational Health and Safety Management Systems standard, which may ultimately include many labor standards that have never been adopted in the U.S.

ISO 26000. ISO has also begun a review of the controversial ISO 26000 standard on social responsibility. To read the full GT Alert on ISO’s ongoing standard revisions and ongoing new projects, [CLICK HERE].

SPEAKING ENGAGEMENTS

Greenberg Traurig, LLP sponsored and hosted an Israeli Medical Device and Bio-Pharma Delegation on December 10, 2013 at the firm’s Boston, MA office. Greenberg Traurig was lead sponsor at ACI’s 18th Annual Drug and Medical Device Litigation Conference and Lori Cohen spoke on a panel titled “Conducting Successful Voir Dire and Selecting the Right Jury: Novel Strategies, Tactics and Ethical Considerations” on December 10, 2013. J. Rick Taché and Ginger Heyman Pigot spoke at the 2013 MassDevice Big 100 West conference on December 10, 2013 at the Hyatt Hotel in Irvine, CA. Justin Prochnow spoke at BevNET Live on a panel titled "Beverage School - Legal Spotlight: Make Claims that Count" and "Legal Update: HPP Concerns and Civil Suits" on December 8-10, 2013 in Santa Monica, CA. David Dykeman was a speaker at the ACI’s 2nd Practical and Tactical Art of the Deal in Medical Device Agreements Conference: M&A, Licensing, Co-Development, and Collaborations on November 19-20, 2013 in Chicago, IL. Justin Prochnow spoke at Supply Side West on a panel titled "Caffeine: Not Just in Your Coffee Anymore” on November 14, 2013 in Las Vegas, NV. Nancy E. Taylor spoke at the National Conference of State Legislatures (NCSL) 2013 Health Summit sponsored by the NCSL Executive Committee Task Force on Health Reform Implementation. The summit entitled, “Emerging Changes in Medicaid & the Insurance Marketplace” took place on Sunday, August 11, 2013 and Monday, August 12, 2013 at the Omni Hotel at CNN Center in Atlanta, GA. David Dykeman and Sara Thompson spoke at the 2013 MassDevice Big 100 East conference July 16, 2013 at The Westin Waltham Boston in Waltham, MA. David Dykeman contributed two chapters to the book “Health Care IT: The Essential Lawyer's Guide to Health Care Information Technology and the Law,” edited by Arthur Peabody, Jr. Dykeman co-authored Chapter 7 – “Electronic Health and Mobile Health Medical Technology” and Chapter 8 – “Medical Devices in the Digital Age.” Published on Aug. 23, 2013 by the American Bar Association’s (ABA) Section on Science and Technology Law, this book introduces lawyers, health care professionals, policymakers and the public to technology in health care.

GT IN THE INDUSTRY

DEALS & AWARDS

Greenberg Traurig Atlanta Attorneys Represent Gentiva Health Services, Inc. in Closing $925 Million Credit Facility to Fund Gentiva's Acquisition of Harden Healthcare Holdings, Inc. Greenberg Traurig Shortlisted for Intellectual Property Litigation Team of the Year by LMG Life Sciences Awards. Greenberg Traurig Recognized at Annual Americas M&A Atlas Awards GT was part of the advisory team named by The M&A Advisor as the winners of Healthcare/Life Sciences Deal of the Year for 2013 (over $50 million to $100 million) in connection with Resolute Anesthesia and Pain Solutions, LLC, a recapitalization sponsored by Goldman Sachs & Co. GT, led by David Peck, represented the founding medical practices of Resolute Anesthesia and Pain Solutions in the transaction. The Resolute transaction was also a finalist for M&A Deal of the Year as well.

NEW ADDITIONS AND ANNOUNCEMENTS

Greenberg Traurig Names Victoria Davis Lockard Vice Chair of National Pharmaceutical, Medical Device Health Care Litigation Practice Group Greenberg Traurig Grows Intellectual Property & Technology Practice, Adds Shareholder Dr. Weisun Rao in Chicago Greenberg Traurig Expands Its Atlanta Office with the Addition of Prominent Litigator Clarence Davis Greenberg Traurig Continues Expansion of New York Health Care Practice with Addition of Eileen Hayes in Albany

Our Life Sciences & Medical Technology Group supports clients ranging from start-ups to large multinational public companies and not-for-profit care providers, as well as investors, venture capital and private equity funds, investment banks and public agencies. Our wide-ranging work encompasses numerous industry sectors, including biomedical engineering, biotechnology, chemistry, cosmetics, dietary supplements, disease management, drug delivery, EMR, billing and coding, immunology, medical devices, microbiology, nanotechnology, pharmaceuticals, stem cells and vaccines. For more information on our Life Sciences and Medical Technology Group, please visit http://www.gtlaw.com/Experience/Industries/Life-Sciences-Medical-Technology.

Greenberg Traurig, LLP is an international, full-service law firm with approximately 1750 attorneys serving clients from 36 offices in the United States, Latin America, Europe, the Middle East and Asia. In the U.S., the firm has more offices than any other among the Top 10 on The National Law Journal's 2012 NLJ 250. For additional information, please visit www.gtlaw.com.

SUMMER 2013

GREENBERG TRAURIG'S LIFE SCIENCES & MEDICAL TECHNOLOGY GROUP

Newsletter Editor GT Life Sciences & Medical Technology Co-chairs

Tracy Mabry mabryt@gtlaw.com Orlando Office Direct: 407.254.2641

David Dykeman dykemand@gtlaw.com Boston Office Direct: 617.310.6009

David Peck peckd@gtlaw.com Fort Lauderdale Office Direct: 954.768.8265

This Issue’s Contributors

Nancy E. Taylor

Co-Chair, Health & FDA Business Practice taylorn@gtlaw.com Washington, D.C. Office Direct: 202.331.3133

Mark D. Kemple

Shareholder kemplem@gtlaw.com Los Angeles Office Direct: 310.586.7864

Angela Diesch

Associate diescha@gtlaw.com Sacramento Office Direct: 916.868.0706

Justin J. Prochnow

Shareholder prochnowjj@gtlaw.com Denver Office Direct: 303.572.6562

Eleanor (Miki) A. Kolton

Of Counsel koltonm@gtlaw.com Washington, D.C. Office Direct: 202.331.3134

Weisun Rao, Ph.D.

Shareholder raow@gtlaw.com Chicago/ Shanghai Offices Direct: 312.456.1006

Mary K. Marks

Of Counsel marksm@gtlaw.com New York Office Direct: 212.801.3162

Philippe M. Bruno

Shareholder brunop@gtlaw.com Washington, D.C. Office Direct: 202.331.3193

Emilie van Hasselt

Of Counsel vanhasselte@eu.gtlaw.com Amsterdam Office Direct: +31 20 301 7354

Tricia A. Asaro

Shareholder asarot@gtlaw.com Albany Office Direct: 518.689.1416

Benjamin M. Friedman

Associate friedmanb@gtlaw.com Albany Office Direct: 518.689.1488

Wendy Johnson Lario

Chair, New Jersey Labor & Employment Practice lariow@gtlaw.com New Jersey Office Direct: 973.443.3274

Edward B. Chansky

Shareholder chanskye@gtlaw.com Las Vegas Office Direct: 702.599.8016

Christopher L. Bell

Shareholder bellc@gtlaw.com Houston Office Direct: 713.374.3556

CONTACT INFORMATION