Life Sciences Practice

Bondoc si Asociatii SCA is a leading Romanian law firm advising private corporations, public entities and lending institutions in the development of significant and increasingly integrated projects in a wide range of practice areas, including corporate and commercial law, M&A, banking & finance, energy, capital markets, competition law, labor, real estate, IT&C, regulatory and compliance. Its lawyers are specialized in providing integrated advice on virtually every legal aspect associated with complex cross-border transactions, as well as domestic projects.  

Bondoc si Asociatii has a formal alliance with White & Case LLP regarding Romania.  While providing legal advice on Romanian-related matters, Bondoc si Asociatii works in unison with White & Case lawyers across 39 offices in 26 countries, bringing global breadth to each case.This applies to life sciences as well.

Regarding the pharmaceutical sector, Bondoc si Asociatii thus has leading experience in Romania and is regularly assisting on a broad range of issues companies representing over 30% of the main 20 players active in the Romanian market.

We provide counsel and representation in virtually every area of law that affects the Healthcare and Life Sciences industries, including negotiating licensing agreements, co-development agreements and strategic alliances in the life sciences sector, and also on antitrust law, competition, regulatory, crisis management and dispute resolution matters involving biotechnology, medical devices and pharmaceutical products / treatments. 

Main areas involving our team on a daily basis include:

Competition law experience in connection with the life sciences field

  • Agency agreements;
  • Change of business model;
  • Competition law compliance trainings, including mock dawn raids;
  • Co-promotion agreements;
  • Dawn raids;
  • Differentiated pricing;
  • Discount schemes;
  • Distribution agreements;
  • Dominance issues;
  • Exclusivities;
  • General terms of business;
  • Handling sensitive correspondence with commercial partners;
  • Investigations of the Romanian Competition Council;
  • Quotas;
  • Merger control;
  • National and hospital tenders;
  • Pass-through discounts;
  • Parallel trade (both in and out Romania);
  • Pricing;
  • Refusal of supply;
  • Other issues related to vertical or horizontal relationships.

Regulatory experience

  • Advertising and promotion of medicinal products;
  • ARPIM Code;
  • Clinical studies;
  • Claw-back tax;
  • Co-promotion agreements;
  • Data protection (including regarding websites);
  • Dealings with the National Drugs Agency and with the Ministry of Health; 
  • Distribution of medicinal products and medical devices;
  • Drugs donations;
  • General terms of business;
  • Good Distribution Practices;
  • Handling ethics compliance issues;
  • Hospitality;
  • HTA related aspects;
  • IP transfer agreements;
  • Labelling and packaging issues;
  • Legal changes in the healthcare field;
  • Marketing authorization issues;
  • Market studies;
  • Medical devices related agreements;
  • Parallel imports;
  • Pharmacovigilance issues;
  • Protocols with the National Insurance House;
  • Pricing regulations;
  • Reimbursement issues;
  • Standard operating procedures;
  • Sponsorships;
  • Sunset clause dealings;
  • Warehousing agreements;
  • Wholesale distribution license applications.

Corporate / M&A

  • Acquisitions and sales of companies and assets;
  • Capital increases and decreases;
  • Concluding various commercial agreements (e.g., distribution, agency, co-promotion agreements);
  • Corporate restructurings;
  • Corporate governance;
  • Debt assignment;
  • Establishing companies, branches and representative offices;
  • Factoring aspects;
  • Joint ventures with private and public entities;
  • Mergers and spin-offs;
  • Netting/cash management agreements;
  • Outsourcing business activities;
  • Registrations;
  • Termination of certain operations and Transfer of business/ divestments.

Dispute resolution / crisis management

Our team regularly advises major pharmaceutical and healthcare players in connection with the following dispute resolution and crisis management matters, such as:

  • State budgetary issues;
  • Debt recovery aspects;
  • Guarantee instruments;
  • Handling state authorities investigations / proceeding;
  • Handling the risk of non-payment of commercial debt;
  • Handling sensitive correspondence with distributors;
  • Insurance breach-related issues;
  • Insolvency proceedings in connection with distributors;
  • Litigation with employees, distributors or other commercial partners;
  • Litigation involving state authorities;
  • Settlement and debt rescheduling agreements;
  • Trademark infringement issues. 

Other

While less industry specific, our team provides legal assistance to clients in the healthcare and life sciences industry on the entire range of Romanian legal aspects, including, with respect to employment, real estate, transfer of business, insurances and various types of contracts.