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Unlocking Opportunity Baker & Mckenzie Paves the Way to Success in Pharmerging Markets the Go-To Firm for Pharmerging Markets

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Unlocking Opportunity Baker & Mckenzie Paves the Way to Success in Pharmerging Markets the Go-To Firm for Pharmerging Markets 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 pharmaceutical industry 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 Boots plc, a Advised Nycomed in its USD214 Represented Smiths Medical leading pharmacy-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 Healthcare Pharma: 15.9% Diverse legal systems among member & Healthcare: 10.7% countries — common law and codified civil laws MALAYSIA 2011-12 market growth Pharmaceuticals Pharma: 10.2% Healthcare: 6.9% SINGAPORE OUR LOCAL PHARMACEUTICAL & 2011-12 market growth HEALTHCARE PRACTICE reports, Pharma: 4.5% Healthcare: 10.9% country 8 2014 OFFICES Q2 THAILAND 37 BMI 2011-12 market growth INDONESIA Pharma: 4.1% LAWYERS Healthcare: 5.7% 2011-12 market growth 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
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