Dechert and Life Sciences A GLOBAL MULTI-DISCIPLINARY TEAM. EXPERT LAWYERS. ADVICE THAT ADDS VALUE.

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1 Dechert and Life Sciences A GLOBAL MULTI-DISCIPLINARY TEAM. EXPERT LAWYERS. ADVICE THAT ADDS VALUE. D 1

2 In France, Dechert life sciences lawyers handle their clients most complex and strategic matters in close liaison with a dedicated global platform. 35+ LAWYERS IN FRANCE 27 OFFICES 12 COUNTRIES 2

3 THE LIFE SCIENCES TEAM IN FRANCE Dechert s life sciences team in France advises companies at all stages of their development. We also provide assistance to investment funds and other investors in connection with their transactions in this field. The Paris team is part of a global life sciences platform that encompasses legal, tax and regulatory expertise, helping clients achieve successful outcomes from complex and strategic operations such as: acquisitions and divestitures of assets; acquisitions of stakes in companies; reorganizations; licensing in-and-out; clinical trial, contract manufacturing, co-development, sponsorship and distribution agreements; optimization and capturing of value from R&D and patents; patent and trademark enforcement, product liability and administrative disputes; antibribery investigations; and research tax credit. Attorney advertising. Prior results do not guarantee a similar outcome. 3

4 Dechert provides ongoing support to all those involved in life sciences. Pharmaceutical companies Investment funds and other investors Hospitals, clinics and nursing homes Contract research organizations (CROs) and contract manufacturing organizations (CMOs) 4

5 Biotech, medtech Pharmacies, laboratories Animal health companies Manufacturers of borderline products, combination drugs and cosmetics 5

A complex environment affects all companies operating in the life sciences sector. Increased competition from generic and biosimilar drugs. Pressure on healthcare product prices.

6 A complex environment affects all companies operating in the life sciences sector. Increased competition from generic and biosimilar drugs. Pressure on healthcare product prices. Partial privatization, opportunities for growth and financing. Financing breakthrough innovations. Increasing complexity and constant change in the regulation of healthcare products, market access, and the relationships between life sciences companies and healthcare professionals. 6

7 Drug life cycle management. Complex legal environment: marrying French law with the EU s legal framework and with U.S. regulations. Growing pressures from greater state involvement and more prevalent corporate social responsibility. Change in business models, in particular through the outsourcing of risks, research and development. 7

8 Many challenges affect our clients daily. Chief Executive Officers and General Management General Counsel, Legal and Litigation Departments Regulatory Affairs Officers Chief Communications Officers IP, Trademark, Patent and R&D Departments Chief Financial Officers and Finance Departments Chief Science Officers Partnership Managers/Chief Development Officers Responsible Pharmacists and Clinicians M&A Departments Compliance Officers 8

9 Minimizing risk. Managing the company s interests and its reputation in the event of legal proceedings. Capitalization on existing therapeutic innovations. Managing operations (contracts, internal growth) and access to capital to sustain company activities. Financing of product development and growth. Creation and enforcement of intellectual property. Monetizing and capturing value from innovations. Integration of technology issues in the business model, development of new markets and external growth. Balance between the organization s strategy and legal, tax and regulatory constraints. Acquisition of market share in emerging countries. Compliance with procedures and related implementation issues. Product life cycle management. Sustainability of the company s business model and its legal position. Reputational risk management and managing relationships with all stakeholders. 9

10 A complete range of services. 10

11 DEFENSE - Complex litigation/patent and trademark disputes - Commercial and investment arbitrations - Investigations and abuse of position - Product liability Regulatory GROWTH - Private equity and M&A transactions - IPOs/corporate fiinance and capital markets - Merger control - Technology issues - Taxation - Compliance ASSURANCE - Antitrust/competition law and trade practices - Data protection and e-health - Product life cycle/patent expirations - Comprehensive offer and pay for performance (P4P) INNOVATION 11

12 For more than 25 years, a global, multidisciplinary team has been helping life sciences companies develop. 12

13 Why Dechert? GLOBAL COVERAGE AND CULTURE The ability to interact locally while responding to global challenges. A global network of lawyers with dual qualifications (business degrees, scientific qualifications, LLMs and healthcare law degrees). A strong entrepreneurial culture. CLOSE INVOLVEMENT AND STRONG NETWORK A team that participates actively with professional organizations, research institutes and industry associations (SNITEM, LEEM, AIPPI, APRAM and CCI). A network of solid relationships with decision-makers. More than 150 lawyers dedicated to life sciences worldwide including nearly 70 in Europe. EXPERIENCE AND EXPERTISE In-depth knowledge of the challenges facing each sub-sector within life sciences and daily contact with the major players, agencies and institutions (ANSM, HAS, European Commission, EMA, FDA and French Ministry of Health). More than 25 years experience in life sciences. 13

Case studies that highlight our expertise. FRENCH MEDTECH Assistance with fundraising operations.

to a private equity fund in an international context. FRENCH BIOTECH Assistance with the biotech s sale to a large Swiss pharmaceuticals company.

unwinding incentive plans. U.S. PHARMACEUTICAL COMPANY Representation in a pan-european infringement dispute.

We also assisted when an opposition was filed in the European Patent Office against the patent of the U.S. pharmaceutical company.

14 Case studies that highlight our expertise. FRENCH MEDTECH Assistance with fundraising operations. After the sale of the medtech to an Asian pharmaceutical company, we assisted the company and its shareholders in fundraising and in the divestiture of a minority stake to a private equity fund in an international context. FRENCH BIOTECH Assistance with the biotech s sale to a large Swiss pharmaceuticals company. We assisted the company and its shareholders by drafting and negotiating the documentation relating to the sale, securing the return of intellectual property rights and unwinding incentive plans. U.S. PHARMACEUTICAL COMPANY Representation in a pan-european infringement dispute. We obtained the first-ever provisional injunction by a pre-trial judge in a patent infringement dispute, later confirmed on appeal. We also assisted when an opposition was filed in the European Patent Office against the patent of the U.S. pharmaceutical company. FRENCH BIOTECH Representation in an action for breach of contract, misappropriation of trade secrets and patent infringement in France, Belgium and the United States. We obtained favorable provisional decisions in France, Belgium and the United States and a favorable decision in France that awarded 15 million in compensation for damages arising from the breach of an exclusivity clause. 14

PHARMACEUTICAL LABORATORY Assistance to a private equity fund in connection with the secondary leveraged buyout on the laboratory.

INTERNATIONAL BIOTECH Assistance with litigation before the French administrative supreme court (Conseil d État) and the French competition authority (ADLC).

We assisted during an inspection by the ADLC investigating the existence of competitive distortion caused by the biotech s opposition to this off-label use.

We helped resolve a complex dispute related to regulations governing pharmaceutical product development.

15 PHARMACEUTICAL LABORATORY Assistance to a private equity fund in connection with the secondary leveraged buyout on the laboratory. We assisted in the acquisition process by filing a preemptive offer, negotiating the acquisition agreements and implementing the management package. INTERNATIONAL BIOTECH Assistance with litigation before the French administrative supreme court (Conseil d État) and the French competition authority (ADLC). We acted before the Conseil d État to challenge a decree and a decision that authorized off-label use and the repackaging of one of the biotech s drugs. We assisted during an inspection by the ADLC investigating the existence of competitive distortion caused by the biotech s opposition to this off-label use. PHARMACEUTICAL LABORATORY Advice on a complex post-acquisition dispute. We helped resolve a complex dispute related to regulations governing pharmaceutical product development. BIOPHARMACEUTICAL COMPANY Advice on the reorganization of the French subsidiary. We advised on the reorganization of the French subsidiary, including handling individual and collective redundancy procedures specific to the pharmaceutical sector. We also provided regular assistance with regard to the management of contracts, the bonus plan and stock options. 15

16 Our commitments are based on a relationship of trust. 16

17 PRAGMATISM Precise operational answers to your questions. BUSINESS-ORIENTED ADVICE A business approach to all matters with understanding of your needs. FLEXIBILITY A flexible organization adapted to your needs, with services tailored to the issues you face. EFFICIENCY A focus on time-saving that allows you to concentrate on your core business and add value to your activities. TRANSPARENCY A structured process that offers you visibility over fees throughout the entire matter. 17

18 Dechert, a recognized player in the life sciences sector. The outstanding Dechert LLP shows depth of expertise, great responsiveness to clients needs and responds by tailor-made services. The firm has great industry knowledge and understands and adapts very well to constraints of a start-up company. The practice has a wide client base made up of promising biotech firms and large pharmaceuticals groups. It provides a full range of expertise: M&A, private equity, regulatory and competition, patent and product litigation proficiency. THE LEGAL Dechert ranked Tier 1. Top-ranked team assisting with a number of competition law and capital markets issues within the life sciences sector. Additionally skilled in corporate law, M&A transactions and disputes. CHAMBERS 2018 Dechert ranked Band 1. Received Silver Award for Healthcare and Pharma in France. Excellent in patent litigation in Pharma, Biotechs and Life Sciences. Excellent in antitrust and in regulatory law in Health, Pharma and medical devices. Leading practices in product liability disputes and in joint-ventures, capital operation and corporate in Health, Pharma and Life Sciences. DÉCIDEURS MAGAZINE 2017/2018 Dechert ranked among the best law firms. 18

The lawyers consistently add significant value at both the strategic and operational level, in several circumstances even beyond purely legal matters.

19 The lawyers consistently add significant value at both the strategic and operational level, in several circumstances even beyond purely legal matters. Their final products are impeccable and delivered in a timely manner. They re really people who you can put your trust in. CHAMBERS 2017 Alain Decombe and Mélanie Thill-Tayara ranked among the best Pharma/Life Sciences lawyers in France for Corporate, Antitrust/Competition Law and Regulatory issues. THE LEGAL 500 AND CHAMBERS

20 YOUR CONTACTS IN FRANCE Alain Decombe Partner Corporate and securities alain.decombe@dechert.com Marie Fillon National partner Intellectual property marie.fillon@dechert.com Xavier Nyssen Partner International arbitration xavier.nyssen@dechert.com Jacques Sivignon Partner Complex commercial litigation jacques.sivignon@dechert.com Mélanie Thill-Tayara Partner Antitrust/competition melanie.thill-tayara@dechert.com Sophie Pelé National partner Regulatory sophie.pele@dechert.com Isabelle Marguet National partner Corporate and securities isabelle.marguet@dechert.com Anne-Charlotte Rivière National partner Corporate and securities anne-charlotte.riviere@dechert.com About Dechert Dechert is a leading global law firm with 27 offices around the world. We advise on matters and transactions of the greatest complexity, bringing energy, creativity and efficient management of legal issues to deliver commercial and practical advice for clients. Our team in France has more than 90 lawyers focused on regulatory, intellectual property, antitrust/competition, corporate and securities, international arbitration, complex commercial litigation, tax, labor and employment and financial services matters dechert.com linkedin.com/company/dechert-llp twitter.com/dechertllp

Tokyo Office. Local Roots OVER FOUR DECADES IN JAPAN. Japanese attorneys. Gaikokuho Jimu Bengoshi. Tax attorneys.

Tokyo Office. Local Roots OVER FOUR DECADES IN JAPAN. Japanese attorneys. Gaikokuho Jimu Bengoshi. Tax attorneys. TOKYO Local Roots OVER FOUR DECADES IN JAPAN Baker & McKenzie (Gaikokuho Joint Enterprise) is one of Japan s leading international law firms as well as one of its oldest. It is also the largest foreign