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KIELTYKA GLADKOWSKI KG LEGAL PARTICIPATED AT DOW JONES WEBINAR

Publication date: January 15, 2025

On 14 January 2025 Patryk Piecha of KIELTYKA GLADKOWSKI KG LEGAL had the great pleasure of participating in a webinar organized by Dow Jones devoted to “Sanctions: The Outlook for Policy and Enforcement.” This was a chance to familiarize with experts’ opinions on the impact of the incoming U.S. administration under President-elect on global policy and the economies of U.S. allies and the European Union. The speakers were Nicholas Elliott, Miroslava Panuscikova, Tom Blass, Rachel Ziemba, and Rachel Fiorill. The webinar consisted of two parts. The speakers firstly provided a detailed analysis of various statistical data, such as the monthly changes in sanctions from 2020 to 2024, with particular attention paid to the sudden changes starting in February 2022 (Russia’s aggression against Ukraine), when there was a significant increase in sanctions imposed, particularly by the EU on Russia. The biggest leader in sanctions during this period was OFAC, the U.S. Office of Foreign Assets Control. The speakers also discussed UN sanctions (on various countries), which have remained unchanged over the past two years, while EU sanctions have been undergoing substantial changes, especially with respect to Ukraine.

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Briefing of flagship cases for the 2024/2025

Publication date: January 14, 2025

The turn of the year was particularly busy for the lawyers of KIEŁTYKA GŁADKOWSKI KG LEGAL. Our team has been trusted by representatives of top law firms and global business corporations. Since the profile of the law firm is a result of experience, we would like to present flagship cases that, like in a lens, focus the profile of our law firm specializing in cross-border cases:

1/ CROSS-BORDER TRANSACTION OF THE SALE OF THE WORK OF ART – unique transaction value

Our team dealing with cross-border matters supported with its legal services the world’s most renowned British auction house, which mediated in the sale of a handwritten document of one of the most important artists of Polish origin to a Polish cultural institute established under a separate Polish act.

KIEŁTYKA GŁADKOWSKI advised on:

– negotiation of payment security under the direct public procurement procedure and budget subsidy from the Ministry of Culture for the purchase of a work;

– representing an intermediary selling the work of art in the procedure of temporary transit of the work for auction purposes before customs authorities;

– negotiations regarding contractual obligations regarding the provenience of the work.

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Application of the look-through approach concept in Poland.

Publication date: January 14, 2025

Practical comments on beneficial owner, treaty shopping, beneficial owner clauses for dividends, beneficial owner clauses for interest, substitute companies and abusive clauses, the status of a beneficial owner in various types of intermediary centres between service orderers and service providers, withholding tax on interest paid within the cash pooling structure.

Basic definitions

The look-through approach (also known as LTA) is an issue in international tax law concerning the problem of double taxation, also related to the issue of the so-called withholding tax. It allows for the application of preferential double taxation rates based on a double taxation treaty concluded between Poland and the country of the beneficial owner’s seat, in the scope most often concerning dividends, interest and royalties. However, only an entity with the status of a beneficial owner, is entitled to such privileges.

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General provisions of the Civil Code and claims of a company whose logo or business name has been violated – analysis

Publication date: January 14, 2025

When considering infringement of a company’s logo or name in light of the provisions of the Civil Code[1], it is necessary to analyze in detail the claims to which the company is entitled and the legal grounds on which they can be based. The company’s logo and name are elements of the designation that individualizes the entrepreneur on the market, which is reflected in the provisions on the protection of personal rights and the right to a company.

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Regulatory Pathways for Super Generics


Publication date: January 14, 2025

Introduction

Super generics, often referred to as hybrid medicines in the European Union (EU) and complex generics in the United States (US), represent an important and growing category of pharmaceutical products. These medicines generally share a similar active substance with an already authorized product but differ significantly in their formulation, strength, route of administration, or indications. Such differences introduce additional value, enhancing therapeutic outcomes or addressing patient needs that existing generics may not fully meet.

In the EU, hybrid medicines are regulated through the European Medicines Agency (EMA). The hybrid application pathway is used for products that demonstrate therapeutic improvements over the reference medicine. This could include differences in dosage forms or additional indications, but the active substance remains the same. Hybrid medicines must meet the standard regulatory requirements for generics while demonstrating clinical efficacy and safety improvements related to the innovation. The EMA’s scientific assessment is central to determining whether the added value is sufficient to justify market approval.

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