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Lawyers of KIELTYKA GLADKOWSKI KG LEGAL as co-chairs and speakers at the Annual American Bar Association International Law Section in Washington DC – May 2024

Publication date: May 20, 2024

Panel programme of Regulatory / Specialty Practice: Developing & Delivering A Cure: Legal and Regulatory Opportunities & Obstacles For Global New Life Sciences
& Health Care Products

Sponsoring Committees: International Life Sciences & Health; International Employment Law

Panelists analyzed legal, regulatory and practical problems and new opportunities for legal development and delivery of modern life science products to
global markets. The program analyzed an interdisciplinary legal problem at the intersection of pharmaceutical and medical law as well as technological
and data protection law solutions complementing the practical approach of modern materials, polymer and software engineering procedures. When modern
functionality lies on the border between diagnostics and the treatment process, the legal trade in medical equipment, as in the case of medicines, requires
the design of product documentation and testing through a formalized clinical trials process in terms of both medical and ethical properties.

Program Co-Chair / Moderator: Gerald Schneeweis, Senior Counsel, Clark Hill LLP, San Diego, CA

Program Co-Chair / Speaker: Malgorzata Kieltyka, Partner, iSTART1

Speakers:

Nicolas Benetatos, Ph.D., Principal, Exponent, Philadelphia, PA

K. Jakub Gładkowski, KIELTYKA GLADKOWSKI KG LEGAL, Warsaw, Poland

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Corporate Sustainability Due Diligence Directive (CSDD): A New Paradigm for Corporate Responsibility

Publication date: May 20, 2024

In the face of a dynamically evolving global business landscape, the European Union is entering a new stage of reforms, moving towards a more sustainable and ethical model of economic development. The planned Corporate Sustainability Due Diligence Directive (CSDD) is an important legal act that will introduce the foundations for a new paradigm of business responsibility. On 24 April 2024, the European Parliament adopted the CSDDD compromise proposal in a plenary vote. The final adoption and announcement of the text of the directive in the wording adopted by the EP and after changes resulting from linguistic and legal verification is planned in the coming weeks.

The announced adoption of the CSDD directive will culminate an approximately four-year process of developing regulations.

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Duties of the Chairman / President of the Management Board in a Limited Liability Company

Publication date: April 25, 2024

Competences of the President in managing the company’s affairs

The management board is an integral element of a Polish limited liability company. It is appointed by the company’s shareholders. The management board appoints its president, who heads it. This involves the president having many responsibilities that he must fulfill.

The president, as a member of the management board, has two functions in taking up matters, because he can take them up himself or he is the executive tool of the shareholders. The president, as a member of the management board, has the right to manage the company’s affairs. This applies to both judicial and extrajudicial matters. Article 208 § 3 of the Polish Commercial Companies Code allows the president to conduct matters not exceeding the scope of ordinary company activities, without a prior resolution of the management board. Activities of ordinary management may refer to internal and external affairs of the company. When deciding which activity exceeds the scope of ordinary activities, consideration should be given to circumstances such as the size and nature of the activity. In short, it is the amount of the company’s available financial resources. In proportion to the activity performed and the company’s budget, it can be concluded whether a given activity exceeds this scope. Of course, the company agreement (articles of association) may specify what activities fall under the ordinary management of the company. Therefore, decision weight is an abstract concept and depends on the conditions of a given entity. All decisions made should be rational, accompanied by documents justifying the decision.

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Remote Voting in Capital Companies – Limited Liability Company and Joint Stock Company

Publication date: April 25, 2024

Decision-making methods in collective bodies of limited liability companies and joint-stock companies.

Limited liability company

The shareholders’ meeting, the audit committee, the management board and the supervisory board are the collective bodies of a limited liability company. The Polish Commercial Companies Code introduces many regulations that allow the use of means of direct distance communication in order to improve the voting process in capital companies. Means of electronic communication are technical solutions, including ICT devices and software tools cooperating with them, enabling individual communication at a distance using data transmission between ICT systems.

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NANDO – a key base for compliant trade in the EU on the example of the segment of medical devices

Publication date: April 25, 2024

The NANDO (New Approach Notified and Designated Organizations) database is an indispensable tool for every sponsor or investor who wants to legally introduce their products to the European Union market.

NANDO constitutes a list of notified bodies authorized to issue documents confirming compliance with EU regulations. Notified unit is an organization appointed by EU Member State (or other countries under specific agreements) to assess the compliance of certain products with the regulations before placing them on the market. As the name NANDO suggests, it refers to all organizations in the European Union notified and designated by the European Union under the political concept called “New Approach” and “New Approach Framework”. This covers a wide range of products, including toys, personal protective equipment and diagnostic devices.

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