Pharmaceutical & Healthcare Global

Unlocking opportunity Baker & McKenzie paves the way to success in pharmerging markets The go-to firm for pharmerging markets

Baker & McKenzie has been helping pioneering companies establish operations overseas since our inception in 1949. Our first cross-border We are the only law firm with client — who we serve to this day — is one of the world’s leading experienced pharmaceutical pharmaceutical and medical products brands. And we continue to be lawyers in all key pharmerging deeply involved in the the world over. markets. Our team of more than 400 pharmaceutical lawyers, engineers and other industry specialists operate from 39 offices across the globe, and we regularly advise the world’s major industry players on the most • Greater China complex cross-border matters. With an established pharmaceutical • Southeast Asia and healthcare practice in 16 of 21 pharmerging markets — developing jurisdictions where industry growth is expected to be significantly • Brazil higher than in mature markets — we are uniquely positioned to help • Pacific Alliance you capture emerging opportunities. • Russia As an integrated and multidisciplinary firm, we can provide a full range of locally relevant advice and innovative strategies. From pipeline • Middle East, Turkey and and geographic development to cross-border mergers, acquisitions Africa and reorganizations, we can help you achieve your business goals in pharmerging markets and the rest of the globe.

2 Expand Our strong multinational capabilities help companies realize full deal values during Pharmaceutical & mergers, acquisitions and joint ventures. We manage strategic partnering in the commercialization of products, along with distribution and supply chain matters, Medical Technology: including financing. Our capabilities Develop Our deep local knowledge in markets that matter enables us to help you swiftly establish The pharmaceutical and medical technology and operate R&D facilities or collaborative development deals, including through industry has long operated across borders, joint ventures. but the growing importance of emerging markets creates new geographic complexities.

Access Advisers seasoned in industry nuances, Familiar with local nuances, we are up-to-date with legal and market issues. Our lawyers as well as emerging markets, are key are active in most pharmerging markets — we create and implement strategy for market access, regulatory approval, and reimbursement issues. If a need for product recall to maximizing rising opportunities and arises, our team is prepared to help. neutralizing cross-border risk.

Enforce An essential consideration before market entry is intellectual property enforcement. Our local experience can guide thinking on this issue, and our lawyers regularly conduct due diligence and prepare freedom-to-operate reports.

Comply New pharmerging markets have increasingly dynamic laws, regulations and industry codes of conduct. With skilled lawyers on the ground, we can assist in ensuring compliance, with respect to promotional activity matters, as well help you effectively respond to regulatory actions and proceedings.

Look ahead We help multinational pharmaceutical companies lobby for regulatory and legislative changes and advise on market strategies to optimize local market exclusivity protocols.

3 YEAR FOCUSES ON Greater China HEALTHCARE REFORM, R&D, BETTER GOV’T PRODUCTION AND QUALITY STANDARDS, AND RESTRUCTURING OPPORTUNITY PLAN +14.7% PHARMACEUTICAL MARKET GROWTH, 2013-14 (projected value: USD99.7 billion)

*source: BMI China Pharmaceuticals & Healthcare Report Q2 2014

BEIJING +13.5% HEALTHCARE MARKET GROWTH, 2013-14 (projected value: USD587.8 billion) SHANGHAI HONG KONG

TAIWAN

OUR LOCAL PHARMACEUTICAL & Baker & McKenzie’s unique position in the People’s Republic of MATTERS TO CONSIDER HEALTHCARE PRACTICE China was built on more than 40 years of experience navigating Licensing and regulatory approvals the jurisdictions’ continuously evolving legal systems. We have at provincial and central levels considerable experience helping Western companies with FDI, 4 mergers and acquisitions, joint ventures and other partnering Strategizing local IP protection OFFICES strategies. Our regulatory and intellectual property teams are 30 familiar with the industry and provide clients with valuable insight into the country’s complex legal environment. Geographic and economic diversity LAWYERS means markets within markets 4 Greater China OUR EXPERIENCE

Advised Medtronic, Inc. on its Advised Cardinal Health on Acted as US legal advisor to USD816 million acquisition of its USD470 million acquisition Hanmax Investment Limited, China Kanghui Holdings, a leading of leading local healthcare Fosun Industrial Co. Ltd and Tonsun provider of orthopaedic devices in distributor Zuellig Pharma International Company Limited, China. This was one of the largest China, known locally as Yong Yu, in connection with their USD117 acquisitions in the industry last which is the country’s largest million acquisition by way of merger year in a BRIC country. pharmaceutical importer. of Tongjitang Chinese Medicines Company, a leading specialty pharmaceutical company in China.

Advised Alliance plc, a Advised in its USD214 Represented Smiths Medical leading -led health and million acquisition of a majority Group Limited in the USD46 beauty group on its agreement stake in Guangdong Techpool Bio- million acquisition of a 100% to form a 50:50 joint venture with Pharma Co., Ltd., a fast-growing equity interest of a domestic the then-controlling shareholder Chinese bio-pharmaceutical company in Hangzhou, Zhejiang of Guangzhou Pharmaceuticals company based in Guangdong. engaged in the manufacture Corporation, the third-largest and sale of syringe pumps and pharmaceutical wholesaler in nutrition pumps. China.

5 ASEAN Economic Community (AEC) Southeast Asia INTEGRATION IN 2015 MEANS A SINGLE MARKET FAIR COMPETITION VIETNAM A SINGLE PRODUCTION BASE OPPORTUNITY 2011-12 market growth Pharma: 23.6% Healthcare: 15.4% MATTERS TO CONSIDER PHILIPPINES Slow evolution — mutual recognition 2011-12 market growth arrangements, not directives, to Pharma: 3.1% harmonize laws Healthcare: 11.9% Application forms for regulatory MYANMAR approval have been developed 2011-12 market growth Pharma: 15.9% Diverse legal systems among member Healthcare: 10.7% countries — common law and codified civil laws MALAYSIA 2011-12 market growth Pharma: 10.2% Healthcare: 6.9% SINGAPORE OUR LOCAL PHARMACEUTICAL & 2011-12 market growth HEALTHCARE PRACTICE Pharma: 4.5% Healthcare: 10.9% 8 THAILAND OFFICES 2011-12 market growth INDONESIA 37 Pharma: 4.1% LAWYERS Healthcare: 5.7% 2011-12 market growth

& Healthcare Pharmaceuticals reports, BMI Q2 2014 country Source: Pharma: 10.6% Healthcare: 14.4%

As the AEC brings together the pharmerging markets of Indonesia, Thailand and Vietnam with the region’s frontier markets, our firm can provide valuable input as market access strategies are developed. Our local experience is extensive — we have been operating in Southeast Asia for over 50 years. Also with offices in seven of the 10 ASEAN nations and correspondent law firms in Cambodia and Laos, we have the most legal coverage in the region. The Firm’s 500 ASEAN-based lawyers and a dedicated AEC

6 SubCommittee help pharmaceutical companies navigate the region’s swiftly evolving regulations and markets with confidence. Southeast Asia OUR EXPERIENCE

Advised Pfizer Inc. on its sale Acted for Valeant Acted for Ramsay Health Care of Pfizer Nutrition to Nestle for Pharmaceuticals International, Ltd., an international hospital USD11.65 billion. We represented Inc. in its USD700 million operator, on a USD525 million joint Pfizer in Thailand, Vietnam, acquisition of iNova across the venture with Sime Darby Berhad Philippines, Malaysia and Asia Pacific. across Indonesia and Malaysia. Indonesia.

Formally appointed law firm Advised a leading European- Advised Eurocham Vietnam of Thailand’s Pharmaceutical based pharmaceutical company Pharmaceutical Group in Research and Manufacturers on issues relating to termination developing the first industry Association (PReMA). Our role of distributorship agreements code of conduct for multinational includes: working with PReMA and transfer of medicinal product pharmaceutical companies in in all key policy issues; advising licenses in Singapore. Vietnam. PReMA in key legal and health policy challenges experienced in the industry; and performing a general legal adviser role.

7 OPPORTUNITY MORE PROSPECTS Brazil BUT INCREASED expanded COMPETITION health BETWEEN LOCAL AND coverage FOREIGN PLAYERS +8.2% PHARMACEUTICAL MARKET GROWTH, 2013-14 (projected value: USD26.2 billion) largest pharmaceutical *source: BMI Brazil Pharmaceuticals & market in 2013 Healthcare Report Q2 2014

BRASILIA +10.6% RIO DE JANEIRO HEALTHCARE MARKET GROWTH, 2013-14 SAO PAULO (projected value: USD206.3 billion) PORTO ALEGRE

OUR LOCAL PHARMACEUTICAL & Our regulatory and IP teams are well aware of the latest events MATTERS TO CONSIDER HEALTHCARE PRACTICE that may affect your business. In Brazil, we work in cooperation Higher standards — ANVISA at the with Trench, Rossi e Watanabe Advogados. They have a long track forefront, collaborating with COFEPRIS record of work with the pharmaceutical and medtech sectors. Their (Mexico) and INVIMA (Colombia) 4 experience includes FDI issues, cross-border M&A, joint ventures Mutual respect for each organization’s decisions on GMP inspection of foreign OFFICES and other partnering. Their regulatory professionals support local manufacturing sites 20 dealings with ANVISA and other market access and expansion issues, Government support focused on local including the Brazilian approach to data exclusivity. They also have and public/private partnerships LAWYERS professionals who support the registration and strategic management ANVISA’s involvement in patent decisions of intellectual property assets — including patents and trademarks. 8 complicates patent position in Brazil Brazil OUR EXPERIENCE

Advised Merck on the formation of Advised Alliance Boots in its entry Advised Dong-A Pharmaceutical Supera RX Medicamentos Ltda., into the Brazilian pharmaceutical Co. Ltd., the South Korea-based a joint venture formed for the wholesale market through the pharmaceutical company, on distribution of pharmaceutical acquisition of an initial 25% equity its USD600,000 acquisition of products in Brazil. shareholding in Athos Farma, Milimport Produtos Medicos e S.A., one of Brazil’s leading Farmaceuticos Ltda., which will pharmaceutical wholesalers. give Dong-A Pharmaceutical product distribution access in Brazil.

Advised GE Healthcare on the Advised a major healthcare player Advised one of the largest antitrust aspects of its acquisition in a deal with a public laboratory pharmaceutical companies in of XPRO, a Brazilian medical in Brazil to sell vaccines and the world regarding campaign devices company. to enter into a Process of contributions in Brazil and Development of Products, which compliance with FCPA and other is an agreement for transferring anti-corruption legislation, as well the vaccine manufacturing Brazilian electoral laws. technology to the government.

9 Pacific Alliance OPPORTUNITY

BOOSTING TRADE MEXICO HARMONIZING REGULATIONS 2011-12 market growth Pharma: 8.9% INTER-INSTITUTIONAL Healthcare: 9.1% COOPERATION AGREEMENTS

STREAMLINING REGULATORY APPROVAL PROCESSES COLOMBIA 2011-12 market growth Pharma: 7.6% Healthcare: 5.4%

OUR LOCAL PHARMACEUTICAL & MATTERS TO CONSIDER PERU HEALTHCARE PRACTICE 2011-12 market growth Potential delays in approvals Pharma: 5.3% Healthcare: 6.2% 8 No centralized authorization system OFFICES 23 Intellectual property protection LAWYERS

Pricing limits CHILE & Healthcare Pharmaceuticals reports, BMI Q2 2014 country Source: 2011-12 market growth Pharma: 8.9% Healthcare: 10% Our Firm has had a strong presence in Latin America for over half a century, well-established in the member countries of the Pacific Alliance. We have been at the forefront of their start in Peru and have closely studied the new trading bloc’s agreements. We assess the likely impact of their decisions to help clients identify and properly address emerging opportunities and risks. Our interdisciplinary group of lawyers and scientists work day-to-day on local regulatory and IP issues 10 in each of these markets. Pacific Alliance OUR EXPERIENCE

Advised Alliance Boots on its Advised ConvaTec on the Advised GlaxoSmithKline on USD638 million acquisition of acquisition of Boston Medical the acquisition of Italmex Grupo Casa Saba, a wholesaler Device, Inc., a distribution S.A., a domestic Colombian and distributor of pharmaceutical company that offers specialized pharmaceutical manufacturer. products and a market leader in medical devices throughout Mexico and Chile. Latin America.

Advised on regulatory, Advised on implementing Advised one of the world’s largest transactional and intellectual comprehensive strategies in pharmaceutical companies on property matters in Colombia to Colombia concerning trademark its entry and establishment of multinational pharmaceutical and copyright registration, operations in Peru. companies, involving distribution, licensing, enforcement and advertising, labeling, anti-piracy programs to ensure commercialization of medicines, complete protection of their medical devices, cosmetics and intellectual property rights. chemicals.

11 Russia & CIS +12.2% RUSSIA AIMS TO PHARMACEUTICAL MARKET GROWTH, 2013-14 GROW HEALTHCARE SPEND TO 7.5% BY 2020 ST. PETERSBURG, Russia IMPLEMENT NATIONAL MOSCOW, Russia HEALTH INSURANCE OPPORTUNITY +7.9% HEALTHCARE MARKET GROWTH, 2013-14

*source: BMI Russia Pharmaceuticals & Healthcare Report Q2 2014

MATTERS TO CONSIDER

Dynamic operating environment

Rapidly changing regulatory standards

ALMATY, Kazakhstan Increasing population size and purchasing power BAKU, Azerbaijan

Kyiv, Ukraine Significant disease burden

OUR LOCAL PHARMACEUTICAL & HEALTHCARE PRACTICE The countries’ complex regulatory and IP scene requires a team familiar with local nuances to assist in business decisions. 5 Present in Russia and the CIS for more than a quarter of a century, we are established advisers to OFFICES multinational and domestic industry players in the region. Ours was the first international law firm to win a 17 pharmaceutical patent infringement action before Russian courts. We continue to advise on significant issues in the industry, with our regulatory and intellectual property focused teams. LAWYERS

12 Russia & CIS OUR EXPERIENCE

Advised the Russian Corporation Advised Alliance Boots plc on Advising numerous multinational of Nanotechnologies (RUSNANO) all aspects of its entry into pharmaceutical manufacturers on establishing a joint venture for the Russian pharmaceutical and medical devices manufacturing and developing wholesale market, including manufacturers with respect to medical equipment for due diligence, negotiations and their interaction with the Russian brachytherapy cancer treatment acquisition of Apteka Holding, antitrust regulator on various in the Russian Federation. the fifth-largest pharmaceutical competition law and compliance wholesaler in Russia. issues associated with abuse of dominance and participation in the state procurement process.

Advising numerous international Advised Takeda Pharmaceutical Legal advisers to Russia’s pharmaceutical and medical on construction, town planning Association of International devices manufacturers on various and utility construction matters Pharmaceuticals Manufacturers regulatory issues relevant to the in relation to a new Nycomed for over 20 years and recipients of industry, including interaction manufacturing facility in the the AIPM award for “Outstanding with healthcare professionals, Yaroslavl region, a landmark Contribution to the Development pricing, clinical trials, advertising project for the development of of the Russian Pharmaceuticals of medicinal products, product a pharmaceutical cluster in the Market”. registration, and others. region.

13 Middle East, Turkey and Africa GOV’T REFORM INCREASING GOVERNMENT INVESTMENT IN HEALTHCARE OPPORTUNITY MOROCCO REDUCED AND STANDARDIZED MEDICINE PRICES 2011-12 market growth QATAR Pharma: 11.3% AN AGING POPULATION Healthcare: 12.2% 2011-12 market growth Pharma: 4.7% Healthcare: 8.2%

MATTERS TO CONSIDER Centralized GCC registration is present; local registration is still sometimes necessary UNITED ARAB EMIRATES Stiff competition from well-established 2011-12 market growth local generics manufacturers Pharma: 2.9% Political instability in a number of states Healthcare: 12.2%

TURKEY Our extensive experience in the META region includes 2011-12 market growth EGYPT complex matters in the pharmerging markets — Saudi Arabia, Pharma: -5% Healthcare: 10.1% 2011-12 market growth Egypt and South Africa. Pharma: 12% Healthcare: 12.1% Active in the dynamic markets of the Middle East and neighboring regions since 1975, Baker & McKenzie is uniquely positioned to help industry players manage the impact of local SOUTH AFRICA legal, economic and social transition on their operations. And 2011-12 market growth OUR LOCAL PHARMACEUTICAL & with a team that includes fluent Arabic speakers, we can work Pharma: 8.9% HEALTHCARE PRACTICE with both English and Arabic documentation. Healthcare: 9.1% In Africa, we assist pharmaceutical multinationals 6 establishing branches in South Africa, which many then use as a springboard to tap into the growing consumer market OFFICES in other Sub-Saharan Africa countries such as Ghana and Source: BMI Q2 2014 country reports, 15 Pharmaceuticals & Healthcare Nigeria. Through our relationships with trusted African LAWYERS Correspondent Firms, we are able to service the larger Sub-Saharan Africa region from our Johannesburg office. 14 Middle East, Turkey and Africa OUR EXPERIENCE

Advised the Menarini Group, the Advised Eli Lilly on the sale of its Advised Aspen Pharmacare Italian pharmaceutical company, diabetes business to Batswadi Holdings Limited on a series in relation to its establishment Pharmaceuticals Proprietary of strategic transactions with of operations in SA and the Limited, a South African GlaxoSmithKline, including the restructuring of its relationship biotechnology company. acquisition by GlaxoSmithKline of a with Adcock Ingram Limited, the stake in Aspen. South African pharmaceutical company.

Advised Abraaj Capital, a Advised numerous global Advising a leading global leading investor pharmaceutical firms on agency healthcare products company on specializing in growth markets, and distribution arrangements branding of pharmaceutical and in connection with the acquisition across the GCC, including co-marketing issues in Turkey. of a 40% stake in the Saudi de-registration of agency Tadawi Company for Health Care, arrangements in both contentious the largest pharmacy chain in and non-contentious contexts. Saudi Arabia.

15 www.bakermckenzie.com

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