Healthcare and Pharmaceutical Industry

Healthcare and Pharmaceutical Industry

About
Experience

As one of the recent developments attention is being increasingly focused on the growth of the level of responsibility of manufacturers of pharmaceuticals and service providers for the quality, state supervision over the activities of the entities operating in this sector has been strengthened, regulatory requirements and rules for the industry are being tighten up.

ALRUD Law Firm renders legal support to foreign and Russian companies in their entering Russian market, and provides general advice on the companies’ day-to-day activities. Our qualified experts advise on a wide range of issues including regulatory requirements for the participants of the pharmaceutical market, as well as on the contract law issues, participate in negotiations with clients’ contractors, take part in drafting of and agreeing on contracts (including distribution, supply, storage, marketing and other contracts), give advice on the issues of structuring of the product supply chain from the manufacturer to the patient.

Our services

Commercial issues

  • drafting of distribution agreements, agency agreements, agreements with medical officers, healthcare organizations, patients associations, marketing agencies;
  • development of effective franchising schemes;
  • formalization of relations in the process of manufacturing (contract manufacturing), inspection of quality of the manufactured product.
  • Regulatory issues
  • matters regarding registration of pharmaceuticals;
  • legal regulation of clinical trials;
  • regulatory legal aspects of activities of pharmaceutical and medical organizations;
  • advice on the price setting, execution of permit / license documentation.

Corporate issues

  • M&A, transactions on sale / acquisition of pharmaceutical companies or companies authorized to develop / manufacture pharmaceuticals, food supplements, due diligence;
  • corporate restructuring;
  • legal support of equity and debt financing;
  • incorporation and legal support of activities of joint ventures, strategic alliances and consortia.

Intellectual property and advertising

  • general legal compliance matters relating to intellectual property;
  • due diligence of existing owners of rights in the intellectual property held by the company;
  • building of IP portfolio for new products;
  • license agreements and franchising, including the issues of transfer and use of know-how;
  • representation in Rospatent on the matters related to trade marks registration and granting patents, and in the Rospatent Chamber for Patent Disputes;
  • peculiarities of advertising of pharmaceuticals, medical goods and medical equipment (including via Internet).

Dispute resolution

  • settlement of corporate disputes;
  • settlement of tax disputes;
  • debt collection;
  • representation in court proceedings related to violation of rights in intellectual property including patent disputes.

Highlights of recent domesticand international work include advising:

Bayer AG

with regard to its acquisition of Monsanto Company, a publicly traded American multinational agrochemical and agricultural biotechnology corporation.

SICPA

in establishing of a joint venture with Russian partners (RDIF and Center for Advanced Technology Development) for conducting business in labelling of pharmaceutical products in the territory of the Russian Federation.

Taisho Pharmaceutical

as a part of global team on the purchase of UPSA SAS and the acquisition of the certain assets of Bristol-Myers Squibb Company and its affiliates exclusively related to the global UPSA business with regard to the Russian subsidiary.

Shire PLC

with regard to acquisition of 100% of shares of Baxalta GmbH, largest producer of the pharmaceuticals for rare diseases ($32 bln. deal).

Shire PLC

on regulatory requirements and distribution agreements, including antitrust aspects of the distribution channels in Russia, agreements with HCPs, laboratories, institutes, advice on localization project for one of the products, clearance of marketing materials and marketing strategy, advice on launch of new products, product liability, certification process, etc.

Shareholders of Veropharm

(one of the leading generic products producer in Russia) in the sale of the company to Abbott Laboratories for 600 mln USD (largest Russian healthcare M&A deal to date).

A shareholder of Solopharm

(one of the largest liquid manufacturing plants in Russia) on minority stake sale to the PE fund Barring Vostok including deal structuring and negotiations on preparation of all documents under the project.

Pharmacy Chain 36.6 and its shareholders and founders

on all M&A deals since 2000 till 2013 including purchases and sales of pharmacy chains, attraction of investors, on the acquisition of shares in EMC health followed by their sale in the amount of USD 110 mln.; as well as on the sale of 52% of shares in the pharmaceutical company Veropharm and founders' (shareholders') withdrawal from the business.

GlaxoSmithKline

on a wide range of issues regarding advertising of pharmaceuticals.

CSL

on entering into clinical trials agreement with the Russian partner.

Dompe

on entering into license and collaboration agreement with the Russian partner.

Heel

on license and distributor agreement termination

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