Our Life Sciences Capabilities

Our Life Sciences Capabilities
We have developed unparalleled expertise and extensive experience in helping life sciences companies to achieve their goals in a very heavily regulated sector.
We regularly assist over 30% of the top 20 pharma producers active in Romania, several large medical services providers, several medical devices companies and numerous other life sciences-related companies. Our very strong experience in Healthcare/Pharma sector represents a marked competitive advantage in M&A transactions as well.
Bondoc si Asociatii is the Romanian member of Conference Bleue, the most reputed network of law firms with strong departments in life sciences in Europe.
Examples of areas in which we assist companies on a regular basis include:
Regulatory
■ clinical studies.
■ claw-back tax.
■ co-promotion agreements.
■ cost-Volume/Cost-Volume Result Agreements.
■ data protection (including GDPR).
■ dealings with CNAS, ANMDM and MS.
■ distribution of medicinal products and medical devices and Good Distribution Practices and SOPs.
■ drug donations and sponsorships.
■ disclosure of expenses (ToV reporting).
■ ethics compliance issues.
■ general terms of business.
■ hospitality.
■ HTA related aspects.
■ IP transfer agreements.
■ labelling and packaging issues.
■ marketing authorization issues.
■ medical services and medical devices – related aspects.
■ parallel imports.
■ pharmacovigilance issues.
■ protocols with the National Health Insurance House.
■ pricing and reimbursement regulations and issues.
■ public service obligations.
■ transfers of value agreements in relation to HCPs.
■ warehousing agreements.
■ wholesale distribution license applications.
Corporate / M&A / Commercial
■ acquisitions and sales of companies and assets.
■ any type of internal corporate operations, including mergers and spin-offs.
■ conclusion of all types of commercial agreements (e.g., distribution, agency, co-promotion agreements, market studies, clinical trials, CV/CVR agreements, campaigns).
■ corporate governance.
■ debt assignment.
■ factoring aspects.
■ joint ventures with private and public entities.
■ netting / cash management agreements.
■ outsourcing business activities.
■ termination of certain operations and transfer of business/ divestments.
Crisis management / Dispute resolution
■ debt recovery aspects and guarantee instruments; Handling the risk of non-payment of commercial debt; Insolvency proceedings in connection with distributors; Settlements and debt rescheduling agreements.
■ handling of state authorities’ investigations / proceedings (ANAF, ANI, DIICOT, DNA).
■ handling of sensitive correspondence with distributors.
■ insurance breach-related issues.
■ internal audits.
■ litigation with public authorities, employees, distributors or other business partners, as well as IP related issues.
■ managing medical malpractices.
■ State budgetary issues.
■ white collar / ethics.
CONTACTS
Lucian Bondoc
Managing Partner
+40 31 224 8400
CONTACTS
Lucian Bondoc
Managing Partner
+40 31 224 8400