Life-science, healthcare, pharmaceuticals

Lex Borealis experts provide comprehensive legal support to pharmaceutical and medical companies, manufacturers of medicines, medical equipment, medical devices, beauty and health products.

We provide structuring and support of transactions with rights to medicines, pharmaceutical substances, including transactions related to intellectual property, etc. Through our significant experience we understand the specifics of Russian Ministry of Health requirements to registration procedures, which are highly important to be taken into account when preparing such transactions.

We have vast experience in execution of contracts with medical institutions (CRO) on conduct of clinical trials and consulting on various issues arising in connection of the clinical trials.

Our practice also includes:

• advising on advertising of both Rx and OTC medicines and medical devices;
• drafting and analysis of distribution agreements, regulations on business activities, rules for selection of distributors, consulting on e-commerce;
• legal support during inspections by regulatory authorities (the Federal Tax Service, the Prosecution Office, Federal Service for Supervision of Public Health and Social Development, Federal Service for Supervision of Consumer Rights Protection and Human Welfare), including legal assistance in administrative and judicial appeals against the results of such inspections;
• providing support for negotiating and excuting of public-private partnership (PPP) agreements, concession agreements and special investment contracts (SPIC) in the field of healthcare;
• legal assistance to participants in public procurement and tenders under Russian Federal Laws No.44-ФЗ and No.223-ФЗ, representation of interests when challenging decisions of the Federal Antimonopoly Service of the Russian Federation;
• resolution of disputes on protection of business reputation of medicine manufacturers.

PROJECTS

Life-science, healthcare, pharmaceuticals 

• Full legal support for the execution of investment agreement and the subsequent implementation of an investment project of ROSNANO and NEARMEDIC PHARMA LLC (Obninsk, Kaluga Region) to establish a GMP production of original preparations and finished dosage forms using nanotechnologies in order to introduce modern medicines for treatment and prevention of influenza and SARS into clinical practice. The total amount of project financing is over 5 billion rubles;
• Support for the execution of license agreement with the Federal State Budgetary Institution “National N.F. Gamaleya Research Center for Epidemiology and Microbiology” on granting NEARMEDIC PLUS LLC the right to produce and sell tests to detect protective immunity to COVID-19 “SARS-CoV-2-RBD-ELISA-Gamaleya”;
• Support for the execution of agreement on exclusive distribution to the countries of the European Union and MENA (countries of the Middle East and North Africa) with one of the largest manufacturers of generics and Consumer Healthcare products — STADA Arzneimittel AG in favor of an Italian manufacturer of a collagen-based cosmetic product;
• Support for the sale of the NEARMEDIC group of companies by transferring 100% of the shares of the Cyprus company NEARMEDIC INTERNATIONAL LIMITED in favor of NEW INVESTMENT HOLDING JSC (a company within the AFK-SYSTEMA Group) under the law of England and Wales;
• Legal assistance in transfer of rights under a distribution agreement between a big Turkish pharmaceutical company ABDI IBRAHIM Ilac Sanayi ve Ticaret A.S. and Sanofi Russia (the Russian subsidiary of an international French pharmaceutical holding) in relation to the Bronflex drug in the territory of Russia, as well as the rights to the Bronflex trademarks in favor of a major Russian pharmaceutical company;

• Support in the interests of a large Russian medical company for a transaction to purchase an equity stake in the German biotechnology company MedInnovation GmbH, which developed a technology for laboratory diagnostics of various human diseases based on a functional analysis of blood albumin content;
• Support for the reorganization of the publishing business (pharmaceutical magazine), structuring and support of the transaction for the transfer of intellectual rights within the group of companies in order to optimize the ways of financing the activities of the group companies;
• Structuring and support for a transaction concerning the acquisition by a large Russian distributor of test systems Avivir LLC of the rights to Migrenol from the American company Four Ventures Enterprises Inc.;
• Full legal support for the transaction for merger of two chains of medical clinics: NEARMEDIC, which consisted of 4 clinics, and DOCTOR RYADOM, which consisted of 12 clinics, to run the business under the single brand: NEARMEDIC — DOCTOR RYADOM;
• Support for the conclusion of a license agreement with the Federal Polytechnic School of Lausanne (Switzerland) regarding patents for the production and commercialization of a preparation for the treatment of tuberculosis Macozenone (PBTZ) in the Russian Federation and the CIS;
• Support for the execution of a license agreement and a supply agreement with the New Zealand company AFT Pharmaceuticals Limited (New Zealand) for the anesthetic drug Maxigesic;
• Preparation of a memorandum on issues of legislative restrictions and liability in the field of advertising and promotion of medicines and medical devices in the Russian Federation for a major Russian pharmaceutical holding;
• Support, in the interests of a large Russian pharmaceutical holding, for an agreement on the exclusive distribution of medical devices (drug tests for 13 types of drugs) on the territory of the EAEU with a major Dutch manufacturer of test systems Dutch Diagnostics B.V.;
• Support for the execution of a distribution agreement between the leading American company Promega Corporation, a manufacturer of medicines and products for HID analysis, and a Russian distributor;
• Analysis of the distribution agreement with Abbott Laboratories LLC in the interests of a major Russian distributor of medical equipment and test systems;
• Support for the execution of contracts with Tula Pharmaceutical Factory LLC for research and registration of Inlarestin medicine, a contract on exclusive partnership and transfer of rights to a dossier for medicines (Inlartex and Snotum);
• Development of the Anti-Corruption Regulations and preparing materials for the training “Anti-Corruption Management in business activities of Medical Representatives” at the request of a Russian pharmaceutical company;
• Advising on the execution of a distribution agreement with SHISEIDO CO., LTD, the largest Japanese manufacturer of cosmetics, perfumes and hair care products;
• Successful protection of business reputation of the antiviral drug Kagocel® in legal proceedings, resulting in the courts’ decision to satisfy the claims of the manufacturer of the drug, NEARMEDIC PHARMA LLC, against the founder of the media, AJUR-MEDIA JSC, on cessation of distribution of misrepresenting information and publishing the refutations on the sites of online media – DoctorPiter and Fontanka.RU.