Category: Poland

Former UPC Polska Board Member and Chief Legal, Regulatory, Corporate Affairs Officer Dominika Niewiadomska-Siniecka has joined VeloBank as CEO Advisor, Proxy, and Managing Director.

Since October 2022, Niewiadomska-Siniecka has been leading the restructuring and investment process in Velobank and is responsible for legal matters. According to Niewiadomska-Siniecka, “VeloBank is a bridge institution, established as a part of the resolution process of one of the TOP10 commercial banks in Poland. It was the largest restructuring conducted by the Bank Guarantee Fund in Poland as of today, and one of the largest in Europe.”

Before joining VeloBank, Niewiadomska-Siniecka was involved in the successful sale of UPC (a company from the Liberty Global portfolio) to Play (reported by CEE Legal Matters on December 17, 2021), having joined UPC Polska in 2021 (reported by CEE In-House Matters on June 18, 2021).

Between 2020 and 2021, Niewiadomska-Siniecka was the General Counsel, Head of Compliance at Vodeno – a Warburg Pincus portfolio company – in Warsaw, and between 2018 and 2020 she was the General Counsel of Aion – also a Warburg Pincus portfolio company in Brussels. Between 2010 and 2018, she was the General Counsel of the Play telecommunications operator that acquired UPC Polska.

Before moving in-house, Niewiadomska-Siniecka was a Senior Associate with CMS between 2007 and 2009 and with Beiten Burkhardt between 2001 and 2007, and an Associate with Clifford Chance between 2000 and 2001.

“I am thrilled that I can once again participate in such an interesting and unique project. Its complexity and level of difficulty only add color to it. In such a difficult economic and social time, you have to try twice as hard to achieve success and I’m glad that an amazing VeloTeam is working on it.”

Originally reported by CEE In-House Matters.

Domanski Zakrzewski Palinka has advised Polregio on the preparation of framework agreements and tender documentation for the supply of 200 trains. 

According to DZP, Polregio is the largest passenger rail operator in Poland, and “the agreements are worth more than PLN 7 billion, making them the largest order for rolling stock in the history of regional railways.”

“The framework agreements, signed on January 25, with rolling stock manufacturers FPS Cegielski, Newag, Pesa Bydgoszcz, and Stadler Polska, envisage the supply of up to 60 electric multiple units with 130-160 seats and 140 units with 210 seats. The trains will be capable of reaching speeds of 160 km/h and are to be equipped with air conditioning and Wi-Fi. The company will apply for EU funding for part of the contract,” the firm reported.

DZP’s team included Partners Katarzyna Kuzma, Tomasz Darowski, Aleksandra Auleytner, and Marcin Krakowiak, Counsel Tomasz Michalczyk, Senior Associates Tomasz Zielenkiewicz and Michal Przychoda, and Associate Norbert Zakrzewski.

Domanski Zakrzewski Palinka has advised Polregio on the preparation of framework agreements and tender documentation for the supply of 200 trains. 

According to DZP, Polregio is the largest passenger rail operator in Poland, and “the agreements are worth more than PLN 7 billion, making them the largest order for rolling stock in the history of regional railways.”

“The framework agreements, signed on January 25, with rolling stock manufacturers FPS Cegielski, Newag, Pesa Bydgoszcz, and Stadler Polska, envisage the supply of up to 60 electric multiple units with 130-160 seats and 140 units with 210 seats. The trains will be capable of reaching speeds of 160 km/h and are to be equipped with air conditioning and Wi-Fi. The company will apply for EU funding for part of the contract,” the firm reported.

DZP’s team included Partners Katarzyna Kuzma, Tomasz Darowski, Aleksandra Auleytner, and Marcin Krakowiak, Counsel Tomasz Michalczyk, Senior Associates Tomasz Zielenkiewicz and Michal Przychoda, and Associate Norbert Zakrzewski.

As of 1 January 2023, new conditions govern aid in the Polish Investment Zone (PIZ), as indicated in the new regulation implementing the Act on supporting new investments (the new PIZ regulation).

It contains a number of important last minute changes affecting new investments, which may come as an unpleasant surprise to investors familiar with the draft regulation published in August 2022.

In particular, effective 1 January 2023, the new PIZ regulation:

• introduces the principle that a tax exemption based on capital expenditure (as opposed to an exemption based on two years’ payroll costs) will only be triggered after the investment period indicated in the PIZ decision has expired, and therefore usually only several years after the investor has obtained the PIZ decision,
• requires investors to demonstrate that assets (other than land) have been acquired by them as part of a new investment (including in the form of a finance lease) on an arm’s length basis, whether or not the assets have been acquired from a related entity (otherwise the assets will not qualify for the PIZ exemption),
• suggests that the cost of fixed assets will only be eligible once they have been completed,
• indicates that in the case of finance leases, only costs incurred during the validity of the finance lease agreement will be considered eligible,
• with regard to the qualitative criterion “Support for the acquisition of education and professional qualifications and cooperation with vocational training establishments”, to the extent that it would be met by the investor incurring training or education costs of at least PLN 1,000 per employee per year, the obligation to incur these costs applies to 50% of all employees employed in the new plant covered by the PIZ decision (and not only 50% of the employees employed as part of the new investment, as per the previous rules),
• with regard to the qualitative criterion “Taking care of the employee”, the obligation for the investor to bear the costs of non–wage benefits of at least PLN 800 gross per employee per year for the entire period of maintenance of the investment applies to all employees employed in the new plant covered by the PIZ decision (and not only to employees employed in the new investment, as per the previous rules),
• for certain qualitative criteria obliges investors to adopt a three– or five–year period of maintenance of the level of employment,
• introduces other modifications to the qualitative criteria,
• expands the range of waste–related activities that can now be supported to include activities covered by 2015 PKWiU code 38.22.19.0 – Treatment services for other hazardous waste,
• allows for the eligibility of investment costs for energy generation and the costs of related infrastructure if the following three conditions are cumulatively met:

a) energy generation is not the primary purpose of the whole project (most of the costs should not be related to energy generation
b) the energy production capacity is matched to the needs of the company, meaning that the aim is to use the energy produced for own consumption and a maximum of 20% of the energy planned to be produced can be sold (based on an ex ante analysis), and
c) the costs relate only to investments in energy sources that would be eligible for aid under the rules on state aid in the energy sector (this condition would be met by, e.g., RES or high–efficiency cogeneration).

Notwithstanding the above, the new PIZ regulation also introduced other changes, as provided in the draft published in August 2022.

These include, in particular, changes concerning:

• facilitation of reinvestment (due to a 50% reduction in the threshold of respective eligible costs),
• eligible costs relating to the rental or lease of land, buildings and structures,
• how to verify the qualitative criteria,
• the content of the qualitative criteria (including in particular the criteria “Use of human resource potential” and “New investment in renewable energy sources”),
• support in PIZ for investments related to the provision of modern services for business,
• the range of activities excluded from support in the PIZ, and
• obligation of durability (maintenance) of the investment.

We covered the above changes in webinars and meetings in late 2022.

The new PIZ regulation, including all of the above amendments, applies to tax exemptions granted on the basis of applications submitted after 31 December 2022.

By Cezary Przygodzki, Dariusz Stolarek, Partners, Michal Bernat, Managing Counsel and Aleksandra Siemieniec-Dulska, Associate, Dentons

Wardynski & Partners has advised CNS Pharmaceuticals on negotiating a contract to supply Berubicin to the Pomeranian Medical University.

“Berubicin is a medicinal substance being studied for use in oncology, in particular for the treatment of the brain glioblastoma multiforme, as well as other conditions such as central nervous system lymphomas,” Wardynski & Partners informed. “The project will be implemented in the form of a non-commercial clinical trial financed by the Polish Medical Research Agency.”

CNS Pharmaceuticals is a US-based biotechnology company that is researching the use of Berubicin for the treatment of aggressive brain cancers and the development of oncology therapies.

Established in 1948, the Pomeranian Medical University in Szczecin includes the Medicine, Dentistry, Biotechnology, and Health Sciences faculties. According to the firm, it is one of the leading oncology centers in Poland.

The Wardynski & Partners team included Partners Izabela Zielinska-Barlozek, Anna Prigan, Monika Gorska, and Joanna Prokurat, Counsel Joanna Krakowiak, Attorney-at-Law Jakub Macek, and Lawyer Oliwia Kruczynska.

Allen & Overy has advised FLE on its acquisition of the Kopernik Office Buildings in Warsaw from the DWS Group. Linklaters advised the seller.

According to Allen & Overy, “the property, located in one of Warsaw’s main business districts and office concentration areas, on Aleje Jerozolimskie, comprises five office buildings.”

French LFPI group company FLE is a Vienna-headquartered investment advisor for real estate in Europe. The DWS Group is a German asset manager.

“The Kopernik Office Buildings have been with DWS for over 15 years,” DWS Head of CEE Marek Jakubiak commented. “Over the years, the property has proven to be very resistant to market and economic cycle changes, with a stable level of occupancy and fluent leasing transitions. This successful disposal is a testament to the attractiveness of the Warsaw office market and we are pleased to have delivered value to our investors in this region.”

The Allen & Overy team included Partner Michal Matera, Counsel Piotr Przybylski, Senior Associate Malgorzata Jastrzebska, Associates Martyna Tepinska, Katarzyna Fus-Starzec, Michal Galuszynski, and Julia Niedziela, and Legal Intern Marta Wdowiak.

The Linklaters team was led by Of Counsel Adriana Andrzejewska and included Senior Associates Samanta Wenda-Uszynska and Ewa Sinkiewicz and Junior Associate Aleksandra Mielniczuk.

Cytowski & Partners has advised Polish start-up Eleven Labs on its USD 2 million pre-seed financing round with Credo Ventures, Concept Ventures, and angel investors from the UK and CEE.

Eleven Labs is an AI voice technology start-up co-founded by two Polish engineers, Mati Staniszewski and Piotr Dabkowski. The solution it has developed – a deep-learning model for speech synthesis – can convert text to speech. “The company has built generative artificial intelligence for dubbing,” Cytowski & Partners informed.

Credo Ventures is a Prague-based seed and series A stage venture fund. 

The Cytowski & Partners team included Partner Tytus Cytowski and Trainee Associate Kunal Kolhe.

Dentons has successfully represented the interests of Porsche Inter Auto Polska in multiple cases concerning excise taxation on intra-community acquisitions of passenger cars before the Provincial Administrative Court in Warsaw and the Supreme Administrative Court.

According to Dentons, “Porsche Inter Auto Polska regularly carries out ICAs of passenger cars on which it pays excise tax in Poland. When the company meets certain annual sales targets, it is granted discounts on the cars it has purchased and, as a result, receives correcting invoices reducing the originally charged selling price.” The disputes with the tax authority concerned “whether or not the post-transaction discount it received should affect the excise tax base for ICAs of passenger cars. Tax authorities have, for many years, consistently ruled that taxpayers cannot reduce the tax base and recover any overpaid excise tax even if they are granted an after-sale discount. The administrative courts have been unwavering in upholding the tax authorities’ decisions in this regard since 2015.”

The firm’s tax litigation team argued that “taxpayers should have the right to adjust the excise tax base for ICAs of passenger cars. They pointed out that the tax base refers to ‘the amount the taxpayer is required to pay’ which, in this case, is the price of the car that the parties ultimately agreed to.”

According to the firm, “on May 12, 2022, the Provincial Administrative Court in Warsaw handed down landmark judgments in 20 cases.  It ruled in favor of Porsche Inter Auto Polska and confirmed that it is entitled to adjust the excise tax base for ICAs of passenger cars. These judgments are yet to become final and non-appealable.”

“Then, on January 12, 2023, Dentons represented the client in eight cases before the Supreme Administrative Court which overturned earlier judgments, issued by the Provincial Administrative Court in Warsaw in 2018, concerning earlier periods together with the relevant decisions of the tax authorities of both instances, thereby upholding the reversal of the jurisprudential position favorable to taxpayers,” the firm reported.

The Dentons team included Counsel Aleksandra Rutkowska and Senior Associate Aleksander Brzozowski.

SSK&W has advised the shareholders of Milestone Dom Wdrozeniowy on the sale of all shares in the company to BPX. Chudzikowski advised BPX.

BPX – Business Partners eXcellence – is a consulting company specializing in improving business management processes. According to SSK&W, “BPX helps companies in the digital transformation of business, offering comprehensive consulting and IT services at every stage of the project.”

“Milestone Dom Wdrozeniowy is a team of professional consultants, as well as project managers,” SSK&W informed, “helping clients to switch to modern HR and ERP solutions, such as Teta or enova365. Milestone specialists have extensive practical knowledge of human resources, payroll, finance, accounting, and trade, thanks to which they are able to quickly identify the client’s problem and propose an appropriate solution.”

According to Chudzikowski, “the acquisition of Milestone is undoubtedly one of the key investments thanks to which BPX can offer a full spectrum of services in any business area as part of IT implementations.”

The SSK&W team included Partner Szymon Syp and Counsel Iga-Wojtczak Opala.

Chudzikowski’s team was led by Managing Partner Tomasz Chudzikowski and Partner Justyna Jaszczewska.

Editor’s Note: This article was updated on January 27, 2023, to more accurately reflect Chudzikowski’s team composition.

Under the Polish Medical Devices Act of 7 April 2022 (the MDA), surveillance over medical device advertising is exercised in principle by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (the URPL), and in certain cases, by the Minister of Health or the Chief Sanitary Inspector.

Surveillance authorities

Under the Polish Medical Devices Act of 7 April 2022 (the MDA), surveillance over medical device advertising is exercised in principle by the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (the URPL), and in certain cases, by the Minister of Health or the Chief Sanitary Inspector.

Administrative fines

Failure to comply with the rules on medical device advertising can be expensive. According to the MDA, advertising against the rules of Article 7 of the Regulation 2017/745 on medical devices (the MDR), the Regulation 2017/746 on in vitro diagnostic medical devices (the IVDR) or the advertising rules under the MDA, can be subject to financial penalty of up to PLN 2 million (approx. EUR 444,000). Anyone who advertises in breach of the rules can be sanctioned.

A failure to keep or make available to the competent authorities advertising templates or information about the places where the advertisement is distributed is punishable by a fine of up to PLN 50,000 (approx. EUR 11,000). Presenting devices at trade fairs, exhibitions or similar events in a manner contrary to Article 21(3) of the MDR or Article 19(3) of the IVDR is punishable by a fine of up to PLN 1 million (approx. EUR 222,000).

Such high sanctions for regulatory infringements have been adopted in the medical sector for the first time. The practice of the regulatory authorities is yet to be observed.

Other sanctions

In case of a breaches of Article 7 of the MDR or the IVDR, Article 55 or 56 of the MDA, the President of the URPL will be entitled to issue an administrative decision ordering: removal of the identified violation, cessation of the non-compliant advertisement, or publication of the issued decision in the places or mass media where the advertisement appeared (Article 57 of the MDA).

Mitigation of the fines

Pursuant to the MDA (Article 104), the amount of the penalties specified above may not exceed:
• 10% of the maximum fine – If the violation could not cause danger to life or health of users or patients,
• 50% of the maximum fine – If a fine is to be imposed on the same basis for a repeated failure to comply with obligations, and the violation could not cause danger to the life or health of users or patients.
The authority may optionally waive the fine, if the breach was incidental in nature, did not pose any risk, and the entity took corrective action within the prescribed time.

Sanctions under general rules on advertising

Unlawful advertising of medical devices can be also sanctioned under general laws on advertising: Act on radio and television broadcasting, act on combating unfair competition, Act on combating unfair market practices and Act on competition and consumer protection. The most severe among these sanctions can be imposed in case unlawful advertising is considered a practice infringing collective consumer interest – financial penalty of up to 10% of the annual turnover in a year preceding imposing of the penalty.

By Agnieszka Majka, Partner, Celina Bujalska, Senior Associate, and Paulina Roslon-Horosz, Junior Associate, NGL Legal