The Bartsch Life Sciences Group (Julien Sweeting, Marc Blaha & Frederique Borowiec) is a pan-European practice group of legal specialists, who have deep knowledge and experience in the legal aspects of pharma, biotech, devices & medtech and food sectors, including between them over 50 years combined experience working for mid-sized and global pharmaceutical companies, as well as with international law firms. We pride ourselves on the breadth of our experience as well as our international outlook, with members of the team qualified as lawyers in Germany, the United Kingdom, France and Ireland, and also having access to Advoselect, a network of international lawyers.
The sector is highly regulated and in a state of constant change and convergence. We understand your core business needs and the environment in which you operate. We have the necessary expertise to align regulatory compliance and commercial entrepreneurship, both in Germany, the UK, France, Ireland and internationally.
Our team of lawyers can advise on M&A, IP - licensing, technology transfers, development, partnering & collaborations and on a wide range of other commercial agreements to get your products to market, as well as unfair competition and other compliance issues that arise once your products are commercialized.
Our clients are diverse, ranging from start-ups, investors, research institutes, service providers and global players. We offer legal advice on all matters related to customer, product and market requirements. This includes advising on all legal aspects of the complete product life cycle, corporate design and product, service or company focused transactions of any type.
As our lawyers also have significant in-house expertise, we are very familiar with the need to offer practical and streamlined recommendations for businesses. We understand different corporate cultures and can work with specific designed processes. Our team also has substantial experience in data protection law.
Whether through the Bartsch lawyers or the Bartsch network of collaborating law firms, we are also able to access speedy expert legal advice in most countries globally.
IP & Technology transfers
We regularly advise both licensors and licensees, sellers and purchasers on a wide range of transactions involving intellectual property and technology, whether patented or otherwise protected.
We are particularly experienced in IP licensing and technology transfers. We advise on arrangements of all types and at all stages of a product’s life cycle. These include:
- Licensing transactions involving patented technology or regulatory data
- All agreements relating to the development or exploitation of technology and IP
- Joint ventures and strategic partnerships relating to IP & technology
- Agreements for the sale or transfer of IP
These transactions often have an international dimension (eg US/China), with which we are well versed.
We also have considerable expertise in managing and protecting intellectual property.
M&A, Reorganisations, Joint Ventures & Investments
We can advise you on every aspect of M&A and divestments in the life sciences sector, whether your transaction is a share deal or an asset deal, divestment or reorganisation. We advise at the preliminary stage, throughout the due diligence and on the drafting and negotiation of the definitive transaction agreements. Our advice covers all related aspects (including tax, employment, regulatory, intellectual property and data protection).
Our strength and experience put us in a very strong position to provide you the advice in a cost effective manner and help you to quickly identify and address key concerns and to give you the confidence to enter into any proposed transaction with all due risks mitigated. We can support you in the due diligence evaluation of any proposed acquisition of investment.
Similarly, we have extensive experience in structuring and advising on international expansion, whether through joint ventures (contractual or corporate) or other commercial arrangement. (see also Partnering & Development and IP Licensing).
We can also support you if you are a specialist investor in the sector.
We can advise you on domestic, international and cross border transactions. Our team has experience of undertaking transactions in a variety of different European and UK jurisdictions, or under agreements where the governing law of the contract differs from the jurisdiction in which the targets or assets are located.
We can advise on all types of commercial contracts, from manufacturing and supply agreements for raw materials, bulk or finished products, promotion, distribution or wholesaler agreements, the development of standard terms for purchase or sale, or arrangements with healthcare professionals, pharmacovigilance, settlement agreements, etc. We are experts in complex commercial transactions, not only in the healthcare sector but beyond.
We can also support you on all types of indirect procurement contracts, warehousing and logistics, transformation or otherwise.
We can also advise you on a raft of governing law and jurisdictional issues, given that our team is made up of German and international lawyers.
Strategic Partnering (collaborations) & Development
We have extensive experience advising on a wide range of development, co-development, collaboration and strategic partnering arrangements under which new products or software are developed
Clinical Trials, Non-Interventional Studies and appointment of Clinical Research Organizations
We can also advise sponsors, clinical research organisations and trial sites alike as part of service provision in respect to clinical developments, non-interventional studies, the in-licensing of database and other rights from institutions required for a clinical trial, consent requirements and GDPR.
Advertising & Marketing
We provide comprehensive advice on aspects relating to the marketing and advertising of pharmaceuticals, medical devices, food supplements and cosmetics. We review your advertising materials and all your corporate communications for their legal admissibility. In the event of disputes with competitors or competition associations, we will also represent you in court.
We can advise on a wide range of regulatory matters related to the development, marketing and distribution of your life sciences products, including:
- Classification of products
Our experts advise you on compliance issues in the life sciences sector. This includes, in particular, cooperation between industry and healthcare practitioners, anti-corruption, antitrust compliance as well as compliance with industry codes. We support you in the preparation of SOPs and offer training sessions for your employees.
Our team also has substantial experience in data protection, having advised on European data protection implementation for global pharmaceutical and laboratory diagnostics companies. GDPR implementation has been conducted for different life sciences companies, with drafting of user-friendly documents to ensure GDPR compliance.