gblp pharma_eng

Healthcare and Pharmaceuticals

Goltsblat BLP is the Russian practice of Berwin Leighton Paisner (BLP),

an award-winning international law firm

Healthcare and Pharmaceuticals

Medicines and medical, healthcare and beauty products are part of vital daily needs for billions of people, with thousands of companies involved in their development, production and distribution.

Goltsblat BLP / Berwin Leighton Paisner specialists provide comprehensive legal support for both standalone projects and routine operations of pharmaceutical companies, manufacturers of medical devices and equipment, healthcare products and cosmetics, pharmacy chains and retailers.

In the past year, our firm has invested considerably in developing a firm-wide healthcare and pharmaceuticals practice with real strength and depth. Leveraging off the substantial existing client base in this sector and a range of experience spanning several years, the new dedicated healthcare practice has been extremely successful in coordinating different workstreams and using key individuals’ sectoral understanding to interlink such expertise with other areas of specialisation within the firm. New areas of expertise have also been developed, including specific aspects of state regulation of pharmaceutical and medical companies. Healthcare is now an integral part of Goltsblat BLP’s strategy and is fast becoming highly relevant to a number of practice areas across the firm.

This depth in field has enabled the firm to take its healthcare expertise to an international level, resulting in major instructions from key market players.

Goltsblat BLP clients involved in the healthcare sector include major international producers of medications, medical devices and equipment and manufacturers of healthcare products and cosmetics. Internationally, Berwin Leighton Paisner advises NHS Trusts and government bodies, financial institutions, investment consortia, medical suppliers and independent sector treatment centres (ISTCs) and residential care homes.

We have represented both the public and private sectors on some of the earliest, high profile healthcare pilot projects and have a detailed understanding of the readily accepted market positions that we see today. Our experience of acting extensively for both public and private clients means that we understand the differing key aims, objectives and constraints of both sectors.

Many of our specialist lawyers have worked in the industry for a number of years and offer clients a detailed understanding of the sector, combined with integrated and expert advice on the law.

02 / Healthcare and Pharmaceuticals

Healthcare and Pharmaceuticals / 03

Our Services

Business Organisation• Comprehensive legal support for organisation of the pharmaceuticals production process, liaisons with government and municipal

authorities and bodies. Construction and lease of manufacturing facilities, warehouses and office premises• Building up of a distribution network, development of distribution agreements, handling of exclusivity and pricing matters• Advice on optimum franchising models • All-round legal assistance for arranging clinical trials

Regulatory• Regulatory legal aspects of company operations in the pharmaceutical and medical industries• Legal issues associated with medication assignment (donations, provision of samples, etc.) • Ecological, sanitary and environmental implications that producers of pharmaceuticals and medicines might face• Advice on insurance • Drafting enquiries to regulators seeking explanations on the application of legislative provisions

Corporate• Support for business expansion (M&A) and legal due diligence• Corporate restructurings• Legal assistance in attracting equity and debt finance • Setting up and providing legal support for joint ventures, strategic alliances and consortia• Corporate finance• Corporate governance• Corporate dispute resolution• Set-up, reorganisation and liquidation of companies of varied legal status• Insolvency & bankruptcy

Intellectual Property and Advertising • General IP compliance issues• Legal due diligence on existing intellectual assets in a company • Forming an IP portfolio of new assets • Licensing and franchise agreements, including know-how licensing and use• Legal support for combating counterfeit products, including by making the best use of the customs register• Advice on how to use IP assets without infringing on third party rights• Acting for clients in all disputes over violation of intellectual property rights, including patent disputes• Acting before the Russian patent office (Rospatent) on all matters of trade mark registration and patenting, including in the Patent

Dispute Chamber of Rospatent• Advice on specifics of advertising medications, medical products and medical devices, including on the Internet• Recommendations on holding marketing events, legal analysis of promotional events, advice on implementing advertising campaigns,

registration of and legal assistance with lotteries• Acting for clients in disputes with the Russian Federal Anti-monopoly Service, in particular, over violation of the advertising legislation• Trainings on legal aspects of promoting medications (OTC and prescription medicines)• Inclusion of intellectual property items in the customs register of intellectual property items of the Russian Federation and the Common

Customs Register of the Customs Union• Legal support in administrative, civil and criminal cases against importers, manufacturers and sellers of counterfeit goods on the territory

of the Russian Federation

Customs• Legal support for imports of pharmaceuticals and medical equipment into the Russian Federation • Acting for health care and pharmaceutical companies before customs authorities in appealing against resolutions imposing liability for

departures from the customs law• Representing clients in appealing against actions/omissions by the customs and foreign exchange control authorities in courts • Assistance in combating import of counterfeit goods into the Russian Federation and on to the territory of the Customs Union.

Collaboration with the customs authorities


Product Liability• Requirements on quality and safety of medications, self-medication products, medical devices and medical products• Manufacturer’s (seller’s) liability in retail sale of medications, medical devices and medical products• Liability for any harmful effect of medications on human health• Comprehensive legal support throughout interaction with consumers, claim handling and litigation support in consumer disputes• Quality certification for medications

Employment and Immigration • Legal aspects of relations between medical representatives and doctors• Implications of engaging foreign employees from the immigration viewpoint • Paperwork required for LLCs and permanent establishments to hire foreign manpower • Employment restructuring, liaisons with trades unions, and corporate pension schemes

Administrative-Law Support for Business • Legal assistance in relations with government authorities as part of audits, certification and licensing• Legal advice on state purchases, including on the participation procedure, pricing, contesting the results and preparing tender

documentation• Acting for clients before foreign exchange control authorities and the Federal Service for Finance and Budget Supervision, including as

defence in proceedings over administrative offences• Advice on anti-monopoly control over pharmaceuticals, in particular, manufacturing and distribution of medications, medical products and

medical devices

Taxation• Tax restructuring and tax planning• Developing financing alternatives for subsidiaries• Acting for clients before tax authorities and in courts

Personal Data Protection• Advice on application of the Law “On Personal Data”• Legal advice on cross-border transfers of personal data between affiliates• Personal data protection as part of pre-clinical and clinical trials

Dispute Resolution• Representing clients in regional arbitration courts and in courts of general jurisdiction of all levels, including the Supreme Arbitration

Court, the Supreme Court and the Constitutional Court of the Russian Federation• Litigations contesting issue of registration certificates for medicines

ASTRAZENECA

Advised AstraZeneca on applicability of the firm’s global marketing policy and the terms and conditions of its standard distribution agreement in Russia; advised on applying outsourcing models for operations in Russia.

JOHNSON & JOHNSON

For Johnson & Johnson, developed a complete product distribution system for Russia, in particular, elaborated provisions on bonuses and discounts, drafted distribution agreements and developed a document management system for the client.

ORIFLAME

Provided comprehensive support for Oriflame on plant construction projects in the Moscow Region and the construction of service centres in several other Russian regions.

VIRBAC SA

Provided advice to Virbac SA on the proposed transaction to acquire a group of entities engaged in development and distribution of veterinary preparations in Russia.

LEGE ARTIS. CLINICAL RESEARCH COMPANY

Acted for Lege Artis. Clinical Research Company in a move to sell its business to a major US investor.

A LEADING INTERNATIONAL

MANUFACTURER OF MEDICAL EQUIPMENT

Advised a leading international manufacturer of medical equipment on participation in tenders for government contracts and provided trainings for the client’s staff on tender procedures.

A MAJOR MEDICAL COMPANY

Analysed a major medical company’s distribution agreements for compliance with the antitrust regulations.

ONE OF THE BIGGEST HEALTHCARE COMPANIES

Represented one of the biggest healthcare companies and successfully settled out of court a dispute over copyright violation in a TV commercial. We also provide ongoing support to the client for registration and protection of its trade marks in Russia.


Some of our recent representative assignments:


OPTIMA HOLDING GMBH

Advised Optima Holding GmbH of Germany on establishing a joint venture in Russia and attracting substantial mezzanine finance to create a centre for hadron/proton therapy.

A LEADING MEDICAL EQUIPMENT PRODUCER

Advised a leading medical equipment producer on major supplies of medical equipment to state medical institutions, the estimated project value being €6 bln.

ONE OF RUSSIA’S BIGGEST PERFUME AND COSMETICS

RETAILERS

Advised one of Russia’s biggest perfume and cosmetics retailers on its restructuring programme.

SANOFI-AVENTIS

Advised Sanofi-Aventis on re-export of medicines.

KAUPTHING SINGER & FRIEDLANDER

Advised Kaupthing Singer & Friedlander on its £25.9m facilities to SKN Limited for acquisition of the Lasercare chain of laser clinics, backed by Graphite Capital.

DR. REDDY’S LABORATORIES

Advised Dr. Reddy’s Laboratories on trainings on the antimonopoly legislation and legal aspects of medicine promotions; relations between pharmaceutical companies and medical (pharmaceutical) workers.

PFIZER INTERNATIONAL LLC

Advised Pfizer International LLC on the specifics of liaising with Russian antitrust authorities.

KIMBERLY-CLARK

Provided Kimberly-Clark with comprehensive legal support for a project for building a production facility in the Moscow Region.

A WORLD-FAMOUS HEALTHCARE COMPANY

We represented a world-famous healthcare company in its claim for compensation against a German insurance company.

AGFA HEALTHCARE

Advised Agfa Healthcare on a contract with Nuffield Hospitals for provision, integration and support of a group of systems for 40 hospitals and nine mobile x-ray facilities in the UK.

ASTRAZENECA

Arranged and held workshops for AstraZeneca employees on antitrust matters and legal aspects of promoting medications.

PHOTO THERAPEUTICS

Photo Therapeutics - successfully negotiated an amicable settlement of a dispute with the client’s US distributor of a patented technology solution for skin cancer treatment and anti-ageing light therapy.

A LEADING COSMETICS DISTRIBUTOR

Advised a leading cosmetics distributor on its business model relying on multi-level direct selling.

SMITH & NEPHEW

Advised Smith & Nephew on clinical waste management issues.

A WORLD-FAMOUS PHARMACEUTICALS

COMPANY

For a world-famous pharmaceuticals company, drafted a policy on the Russian representative office’s medical research into the company’s products.


AN INTERNATIONAL PHARMACEUTICAL

COMPANY

Advised an international pharmaceutical company on all Russia-related legal matters pertaining to sale of the company’s major global business for €4.2 bln.

A MAJOR FOREIGN PRODUCER OF MEDICAL

DEVICES AND EQUIPMENT

Provided advice to a major foreign producer of medical devices and equipment and hygiene products on aspects of importing medical devices and equipment, licensing patentable items, trade marks and know-how; conducted seminars for the client’s sales and marketing personnel on advertising medications and medical devices.

A LEADING INTERNATIONAL

COMPANY IN THE COSMETICS BUSINESS

Successfully protected the rights of a leading international company in the cosmetics business in court disputes over unlawful use of the client’s trade marks in domain names by Russian cybersquatters.

A GLOBAL GENERICS PRODUCER

Advised a global generics producer on the implications of being included in the register of companies with a market share of more than 35% and developed a strategy to minimise the company’s antitrust risk, including by analysing the client’s internal marketing policy.

A MAJOR GERMAN PHARMACEUTICAL

COMPANY

We acted for a major German pharmaceutical company in a series of patent disputes relating to the client’s inventions initiated under statements of claim filed by companies producing generic medications.

A MAJOR PHARMACEUTICAL

COMPANY

Provided advice on opening and closing down regional subdivisions for a major pharmaceutical company.

A WORLD-FAMOUS MEDICAL EQUIPMENT

COMPANY

Our company advised a world-famous medical equipment company on aspects of lease agreement termination and developed a legal position for use in a relevant dispute.


A MAJOR EUROPEAN COSMETICS

MANUFACTURER

Advised a major European cosmetics manufacturer in the £1.926 bln. disposal of its business to another European producer of cosmetics and household goods.

TEVA

Advised Teva on development of incentive schemes for business partners.

A LEADING FOREIGN COSMETICS

MANUFACTURER

In a lawsuit contesting a resolution passed by the Chamber for Patent Disputes of Rospatent regarding early termination of legal protection for a confusingly similar trade mark, our lawyers successfully defended the interests of a leading foreign cosmetics manufacturer in the Russian Federation’s Supreme Arbitration Court.

SANOFI-AVENTIS, SGS, PROCTER&GAMBLE

Sanofi-Aventis, SGS, Procter&Gamble - provided advice and due diligence services and acted for the clients in negotiations over office lease projects to accommodate the companies’ national headquarters.

ORIFLAME

Advised Oriflame regarding its Russian and Kazakhstan subsidiaries in connection with its subsequent successful IPO on the Stockholm Stock Exchange.


Healthcare and PharmaceuticalsContacts


Vitaly MozharowskiPartner, Real Estate & ConstructionTel.: (495) 287 4444 (Moscow)[email protected]

Nikolay VoznesenskiyPartner, Head of Competition PracticeTel.: (495) 287 4444 (Moscow)[email protected]

Anastasiya Speranskaya Associate Director, Corporate / M&ATel.: (495) 287 4444 (Moscow)[email protected]

Jim BuchananPartner, Projects & InfrastructureTel.: +44 (0)20 7760 1000 (London)[email protected]

Sergey LikhachevAssociate Director,Tax Consulting/ Tax LitigationTel.: (495) 287 4444 (Moscow)[email protected]

Marcus PearlPartner, Commercial, OutsourcingTel.: +44 (0)20 7760 1000 (London)[email protected]

Sergey KurochkinAssociate, Customs and Foreign ExchangeTel.: (495) 287 4444 (Moscow)[email protected]

20th Century Fox AIG Global Real Estate Investments (Russia)Aker SolutionsAkfen REITAlcoaAlfa-Bank Alt TelecomAMT&C GroupAstraZenecaAxel Springer RussiaBarclays BankBarillaBaring Vostok Capital PartnersBASFBrunswick Rail LeasingBulgartabacCaterpillar FinancialCentral PartnershipChina Development BankChryslerCoalcoCoca-ColaCovidienDanoneDeutsche Bank AGDormaEBRDEfesEstee LauderEquifaxFleming Family & PartnersFoundation for development of the New Technologies Development and Commercialization Centre (Skolkovo)Freight One GE Energy GhelamcoGuardianHarrysImmoeastInter RAOInternational Federation of the Phonographic Industry (IFPI) International Financial ClubJapan Bank for International Cooperation (JBIC)Johnson & JohnsonKia MotorsKimberly-ClarkKomatsuKronospanLa PrairieLafargeLeaderLG International Corp.LinstowMagna InternationalMail.ruMarsMedia-Markt-Saturn MerckMitsubishi Motors CorporationMultonNALCONavigation Information Systems NikeNissan / RussiaNord Stream AGNorth Caucasus Development CorporationNovatorOrangina SchweppesOriflamePanasonicPhilipsProcter & Gamble Prysmian S.p.A.Publicis GroupPUIG RUS Quinn GroupRaven RussiaRenaissance CapitalRolfROSATOM - The State Atomic Energy CorporationRoxtec RURusBrandRusHydroRUSNANORussian PlatinumSaint-GobainSandozSanofi-AventisSantekSAPESberbankScaniaSchlumbergerShellSheremetyevo International Airport SiburSick AGSistema-HalsSolae / DuPontSt. Petersburg International Mercantile ExchangeStockmannSUEK SynevoTESCO CorporationTEVATommy HilfigerTomTomUnilever RusUnited metallurgical company (OMK)VEB (State Corporation “Bank for Development and Foreign Economic Affairs (Vnesheconombank)”) VimpelCom (Beeline)Volkswagen GroupVTB CapitalWilliam Grant & SonsX5 Retail Group Yamazaki Mazak (Russia) Zanten

• Goltsblat BLP is the Russian practice of Berwin Leighton Paisner (BLP), an award-winning international law firm headquartered in London and with offices operating in major commercial and financial centres throughout the world - Moscow, Abu Dhabi, Beijing, Berlin, Brussels, Dubai, Frankfurt, Hong Kong, Paris and Singapore.

• More than 100 Russian, English and US-qualified lawyers permanently based in Moscow, the total number of lawyers in all international offices of BLP being over 800.

• Over 800 clients, including: major multinational investors operating in Russia, including 23 Fortune 500 clients, Russian and international banks & financial institutions, and Russian corporates - leaders on the national markets.

• Transactional support for inbound and outbound investments by Russian and international clients.

• Highly reputable local team well-known on the market for its excellent local experience of total legal advice for major Russian businesses and international investors gained over 20 years - from complex/multi-jurisdictional projects to day-to-day operational legal support.

• Goltsblat BLP is consistently top-ranked / recommended by Legal 500 and Chambers in Real Estate & Construction, Corporate/M&A, Dispute Resolution, Competition/Antitrust, Tax & Customs, IP.

• Globally, the firm’s broad-based expertise reaches across more than 50 legal disciplines and 20 industry sectors.

• In Moscow, the firm’s key practice areas are:

• Corporate/ M&A

• Banking & Finance

• Real Estate & Construction

• Dispute Resolution

• Tax & Customs

• Commercial

• Compliance

• Competition & Antitrust

• Employment, Pensions & Benefits

• IP

• Goltsblat BLP is the winner of: International Law Firm of the Year 2014 - The Lawyer European Awards; Client service Law firm of the Year - Chambers Europe Awards for Excellence 2014; International Office of the Year 2010 - The Legal Business Awards (Legal 500); Best Client Service / Award for Excellence 2010 - Chambers Europe Awards; Best Law Firm in Russia 2010 - ILO Client Choice Awards; Innovation in International Expansion 2011 - Financial Times Innovative Lawyer Awards 2011 (a short-list nominee)

• BLP is the winner of, in total, 5 Law Firm of the Year awards and over 30 industry awards in the last few years, including UK Law Firm of the Year 2010 awards by both The Lawyer and Legal Week, Managing Partner of the Year, Real Estate Law Firm of the Year, Best Tax Team in a Law Firm, Planning Team of the Year, PFI/Projects Team of the Year, and Finance Team of the Year and others.

* All names are disclosed with the clients’ permission

Key facts about Goltsblat BLP:GBLP representative client list*

European Awards2014

International Law Firm of the Year

Winner

Goltsblat BLP combines local Russian market expertise with truly international best practices.

The Legal 500 EMEA 2014

The Russian practice of Berwin Leighton Paisner (BLP)

MOSCOW

Capital City Complex Moscow City Business Centre 8, Presnenskaya Nab., Bldg.1 Moscow 123100, Russia Tel.: +7 495 287 44 44 Fax: +7 495 287 44 45 Email: [email protected]

www.gblplaw.com

LONDON

Adelaide House London Bridge, London EC4R 9HA United Kingdom Tel.: +44 (0) 20 7760 1000 Fax: +44 (0) 20 7760 1111 Email: [email protected]

www.blplaw.com

gblp pharma_eng

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healthcare sector

healthcare expertise

firmwide healthcare

medical companies

pharmaceuticals practice

goltsblat blp clients

medical suppliers

number of practice areas