Ekaterina specializes in the legal regulation of commercial activities arising during commercial activities, including the structuring of complex contractual relationships, as well as intellectual property protection and commercialization.
Her expertise encompasses legal matters related to structuring transactions for alienation and licensing of IP assets, the production and distribution of pharmaceuticals and medical devices, and the execution of long-term investment contracts. Her experience includes collaborating with major IT, biotech, pharmaceutical, and FMCG companies.
Selected Experience
Compliance
Ekaterina advised:
major pharmaceutical companies in assessing compliance risks when interacting with TFOMS employees, including analysis of applicable legislation and enforcement practice, as well as developing recommendations to minimise legal and reputational risks;
leading pharmaceutical and FMCG companies in internal investigations aimed at identifying and resolving compliance issues;
a major telecommunications company in an audit of compliance with counter-sanctions legislation and export control laws, reviewing processes, developing an internal organisational structure, including interaction models with existing departments;
a client on developing, implementing and monitoring internal compliance programmes in accordance with Federal Law-61 "On the Circulation of Medicinal Products", GMP standards, and anti-corruption legislation, including Federal Law-273, FCPA and UK Bribery Act.
Advertising
Ekaterina advised:
a major pharmaceutical company in developing internal procedures for promotional and non-promotional materials, including checklists for initial advertising material development;
leading pharmaceutical companies and medical devices manufacturers in daily support on consumer marketing communications, including advertising material review;
pharmaceutical companies on product promotion on online platforms with risk mapping;
major companies on advertising labelling, campaign reporting and developing relevant procedures.
Intellectual Property
Ekaterina advised:
a global pharmaceutical company in preparing a trademark protection strategy, including filing an opposition with Rospatent and subsequent judicial challenge, as well as developing a parallel unfair competition defence strategy;
IT companies in conducting over 20 legal due diligence reviews to determine ownership of intellectual activity results;
a major Russian venture company on trademark protection and ongoing IP operational matters;
a client in an investment project to introduce modern technology in Russia under SPIK 2.0, including structuring contractual relationships with licensors and developing a client know-how protection strategy;
an electric vehicle manufacturer on concluding SPIK 2.0, developing a dealer network contractual model in Russia and advising on IP rights transfer and protection;
a major cosmetics and dental products manufacturer on transferring trademark rights in two foreign jurisdictions with a buy-back option;
a client on patenting and registering a coronavirus vaccine trademark in over 70 countries worldwide;
an international company in developing a software rights transfer contractual model, including analysis of tax and other IT company benefits in the region and preparing all necessary documentation to confirm IP ownership;
a Russian innovative company in developing a model for transferring intellectual activity results under a licence agreement.
Retail and FMCG
Ekaterina advised:
a major cosmetics producer on restructuring the distributor scheme, including developing a supply model for CIS countries;
a leading retail company in an internal legal review identifying key risks (red flags) in current operations;
a major brewing holding on alcohol product circulation and labelling;
FMCG sector companies on advertising law compliance;
a major non-alcoholic beverages producer on unfair competition;
a confectionery producer in developing a roadmap for domestic market entry;
a cosmetics producer on know-how protection, including developing and implementing necessary documentation.
Healthcare and Life Science
Ekaterina advised:
a market-leading medical clinic on franchising;
major pharmaceutical companies in acquiring and selling medicinal products on CIS markets, including comprehensive contractual model development and analysis of regulatory, antitrust, commercial and IP aspects;
leading pharmaceutical companies in daily operational and commercial support (secondment), including acting as the sole lawyer;
pharmaceutical companies on commercial policy development, including economic justification and preparing responses to FAS Russia requests;
major pharmaceutical companies in developing standard documents for key counterparties, including distributor agreements, bonus and marketing agreements with pharmacies;
a major producer of herbal medicinal preparations on providing bonuses to pharmacies to minimise antitrust risks and develop pharmacy interaction policy;
technology transfer projects for medicinal products between foreign and domestic sites (over 5 projects), including supporting the launch of Sputnik V vaccine on international markets;
a US pharmaceutical company in developing a comprehensive import contractual model for post-clinical access taking into account regulatory restrictions, funding specifics and IP requirements;
foreign and domestic pharmaceutical companies in auditing internal processes and developing over 10 local procedures to systematise operations;
development of a legal model and document kit for launching an online store of a medical implants manufacturer targeted at doctors, verifying compliance with medical devices, advertising and data protection laws;
localisation of medical devices production in Russia, including analysis of registration, labelling and state support requirements, as well as recommendations on optimal interaction structure with Russian partners and regulators;
a transaction to acquire a startup specialising in prosthetics development and production, with recommendations on optimal deal structure and protection of key intangible assets;
organisation and legal support of a biological material research project, including analysis of risks of classifying activities as medical and developing recommendations for a safe research format compliant with legislation.
achievements
Ratings and Awards
Ekaterina is endorsed by Russian ratings, including: Pravo-300, Kommersant, Rossiyskaya Gazeta.
Pravo-300 in the nominations: Intellectual Property (Advisory), Pharmaceuticals and Healthcare (Medicine and Healthcare), Pharmaceuticals and Healthcare (Pharmaceuticals), Digital Economy, Antitrust Law, Retail, FMCG, Public Catering
Kommersant in the nominations: Healthcare and Pharmaceuticals, Retail and Trade, FMCG
Rossiyskaya Gazeta in the nominations: Intellectual Property, Healthcare and Pharma