Pharmaceuticals

Team

Ermolenko Alexander

Ermolenko@fbk.ru

Ermolenko Sergey

ErmolenkoS@fbk.ru

Services

Pharmaceuticals

Range of services FBK Legal provides to pharmaceutical industry includes the following competencies: read more >

Corporate law

Legal support of entity reorganization, liquidation and incorporation procedures, accreditation of representative offices
Structuring and supporting transactions, in particular, over the course of investment activities and recovery of investments
Legal due diligence
Legal support to stock issue procedure
Analysing methods of and supporting registered capital increase procedure
Developing and carrying out audit of corporate documents, local papers, analysing and drafting contracts
Registering changes of Managing Directors/CEOs

Legal support of pharmaceutical business operations

Developing marketing policy, product promotion policy
Consulting matters related to personal data protection
Consulting on applicable industry specific legislation
Analysis of risks associated with commission agreements
Comprehensive legal support of cooperation between pharmaceutical companies and distributors
Providing support over the course of formalizing relations with drug manufacturer-plants (subcontracting, reselling operations)
Consulting on matters related to distant selling of drugs and of arrangement for on-line payments
Consulting on various currency and customs legislation related matters
Consulting on matters related to import of registered drugs on to the Russian market, along with drugs that are not registered in compliance with an appropriate approval issued by Ministry of Health of the Russian Federation
Legal support to shipment operations of high value drugs (taxes, customs, public procurement etc.).

Legal support on intellectual property related matters

Drafting recommendations on trade mark changes ensuring their successful registration on the Russian market
Advocacy in disputes with competitors over pharmaceutical trade marks
Protecting patent rights on drugs

Consulting on public procurement of drugs and medical devices
Consulting on labour and employment matters, supporting labour and employment litigations and resolving labour conflicts, drafting regulations on bonuses
Court representation during civil and administrative disputes
Representing companies when interacting with various public bodies (Ministry of Health of the Russian Federation, Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation, Federal Service for Oversight of Consumer Protection and Welfare, Federal Antimonopoly Service of the Russian Federation (FAS), Federal Customs Service of the Russian Federation)
Representation of companies during bankruptcy procedure of their debtors and execution of court rulings on bankruptcy cases
Legal support of debt recovery activities with counter agents
Defence in tax disputes, particularly pre-trial and trial proceedings
Tax audit
Tax consulting:

assessment of tax risks due to bonuses and rewards, along with discounts, particularly credit notes, granted as part of entity’s business practices;
classification activities related to placement of trade marks o to drug package from the tax legislation perspective;
analysis of tax risks and accounting treatment of cost allocation to various types of contracts (agent, advertising, marketing events, licensing, assignment of claims);
tax accounting of marketing, advertising, product promotion, healthcare professional related payment expenses.
tax liabilities for per diem allowance and reimbursable expenses for business travel;
assessment of tax effects from inclusion of provision to reimburse to employee for various expenses into the labour contract;
tax risk assessment in case of individuals working remotely;
transfer pricing in case of assigning logo rights.

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Clients

Actavis, Alexion Pharma, Astellas, Herbalife, Ranbaxy, Sesderma, Xanter pharma, Zentiva, Sanofi, BIOCODEX, Katren, Megard Group (Microgene Pharma), PRO.MED.CS, Protec Group, Rigla, Pharmstandard.

Eager to recommend FBK Legal as a reliable business partner

Sesderma
FBK Legal’s ‘strong team of professionals can be entrusted with any task

The Legal 500 EMEA

Cases

Additional issue of shares for an international pharmaceutical company

Legal support for additional shares issue for an international pharmaceutical company: from preparing a necessary set of documents required for registration of the decision on additional issue of shares with the Bank of Russia and closed subscription placement of shares before the state registration procedure of additional shares issue report is completed. Issuing additional shares will allow the company to attract 160 million roubles in investments. hide

Developing the optimal tax accounting scheme for bonuses at the request one of the TOP-20 leading global pharmaceutical companies

Developing a comprehensive tax policy for bonuses and discounts offered by the pharmaceutical company to its retailers, as well as drafting recommendation to protect company’s interests from tax authority claims.
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Drafting recommendations on company’s trademark changes ensuring their successful registration on the Russian market

Preparing a comprehensive legal opinion for a pharmaceutical company, which is a foreign manufacturer of personal hygiene products and distributes them on the Russian market, decided to register its trademark in the Russian Federation, in particular, developing recommendations on changes to trademarks in order to increase chances for their successful registration with he Federal Service for Intellectual Property, Patents, and Trademarks (Rospatent). hide

Advocacy of a pharmaceutical company during a dispute with a competitor on violation of trademark usage rights

Legal support to a major pharmaceutical company in a pre-trial settlement of a dispute with its competitor, which is a manufacturer of a drug containing the same components and similar trade name as the company. A settlement agreement has been concluded, allowing to avoid payments of multimillion penalties and maintain own business reputation. hide

Pre-trial defence of a major pharmacy retail network as part of a tax dispute

Successful pre-trial representation of a major pharmacy retail network as part of a tax dispute based on the results of a field audit carried out by tax authorities, in particular, related to the incorrect interpretation of the definition “retail pharmacy business” by the tax authority along with additional tax amounts charged for providing discounts/bonuses to customers. The dispute has been completely resolved without legal proceedings. hide

Successful representation in court as part of a tax dispute of a company being a global leader in development of innovative drugs and vaccines

Successful defending at arbitrary courts one of the global pharmaceutical leading companies against which as part of tax audit complaints on underpayment of uniform social tax of were filed. Tax authorities have charged additional amounts of uniform social tax to charity payments and to payments not related to fulfilment of employment duties by the entity’s employees. The courts have agreed with the defence and determined complaints filed by the local tax authority to be invalid. hide

Recovering investments and selling the controlling share in a plant producing drugs

Comprehensive legal support for the return of investments made by a large foreign pharmaceutical company and selling of the controlling share in a drug producing plant. hide

Comprehensive legal support to advertisement of a drug

Detailed analysis of an advertisement campaign for a drug of an international pharmaceutical company and assessment of related risks. hide

Supporting the equity increase by a corporation producing products for balanced nutrition

Supporting $0.3 mln. increase of equity by a Russian branch of an international company working in a healthy life style sector, legal support during a repeated change of general directors, introduction of necessary changes into the charter and revision of contractual relations. hide

Supporting pharmaceutical company on antitrust and other matters

Consulting an international pharmaceutical company on the importing of foreign drugs and beauty products, drafting a distributor agreement and analyzing the situation of view of risks related to the inclusion of a non-compete clause into the agreement to limit the number of distributors in Russia. hide

Supporting the dismissal of top-managers from a leading Czech pharmaceutical company

Representing the interests of a leading Check pharmaceutical company during the dismissal of five top managers caught in the disclosure of confidential information. Investigating each case and evidencing the guilt of every person. All five withdrew their requirements and were fired. hide

Protecting interests of a company in a labor dispute under a claim of an ex-employee for a compensation

Successful court representation of a large pharmaceutical company in a complicated labor dispute under a claim to pay compensation filed by an ex-employee. After the court hearings, the claim was dismissed. hide

Full list

Ermolenko Alexander

Ermolenko@fbk.ru

Ermolenko Sergey

ErmolenkoS@fbk.ru

Linked services

Taxes

Competition / Antitrust

Commercial practice