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.
with regard to its acquisition of Monsanto Company, a publicly traded American multinational agrochemical and agricultural biotechnology corporation.
in establishing of a joint venture with Russian partners for conducting business in labelling of pharmaceutical products in the territory of the Russian Federation.
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.
with regard to acquisition of 100% of shares of Baxalta GmbH, largest producer of the pharmaceuticals for rare diseases ($32 bln. deal).
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.
(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).
(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.
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.
on a wide range of issues regarding advertising of pharmaceuticals.
on entering into clinical trials agreement with the Russian partner.
on entering into license and collaboration agreement with the Russian partner.
on license and distributor agreement termination