February 2024

Frankfurt/Main – Bruker has agreed to acquire ELITechGroup, a provider of specialty in vitro diagnostic (IVD) systems, from TecFin S.à r.l., a controlled affiliate of PAI Partners, a pre-eminent private equity firm, for EUR 870 million in cash, excluding the carved out ELITech clinical chemistry business. The transaction is expected to close in the second quarter of 2024, subject to regulatory approvals and other customary closing conditions.A team of CMS Germany headed by lead partner Dr Hendrik Hirsch acted as lead transaction counsel on this landmark transaction for Bruker's MDx business covering all M&A aspects of the transaction, IVDR and other regulatory aspects, antitrust and FDI filings, the carve out of the clinical chemistry business and support on the employee consultation processes in France and the Netherlands. ELITechGroup, with over 500 employees and over 40 active patents, develops and commercializes innovative, proprietary molecular diagnostic (MDx) systems and assays, as well as niche biomedical systems and microbiology products. Its molecular diagnostic business accounts for the majority of the to-be-acquired revenues and provides the unique sample-to-answer (S2A) instruments InGenius® and Be-Genius® in the mid-to-high throughput MDx category with PCR diagnostic assays for infections and diseases. ELITechGroup, excluding the clinical chemistry business, achieved approximately EUR 150 million in revenues in 2023. ELITechGroup generates the majority of its revenues from Europe, with significant business also in North and Latin America. Its major R&D and production sites are in Italy, the United States, France and Germany. CMS Germany Dr Hendrik Hirsch, Partner, Co-Lead Dr Jacob Siebert, Partner, Co-Lead Dr Dirk Baukholt, Principal Counsel Dr Berrit Roth-Mingram, Counsel Dr Maximilian Stark, Senior Associate, all Corporate/M&A Dr Roland Wiring, Partner Lukas Burgdorff, Associate Noah Rodenkirchen, Associate, all Regulatory & Lifesciences Dr Thomas Hirse, Part­ner Se­basti­an Vautz, Senior Associate Lisa Dietrich, Associate, all IP Dr Michael Bauer, Partner Stefan Lehr, Partner Kai Neuhaus, Partner Moritz Pottek, Counsel Dr. Denis Schlimpert, Counsel Kirsten Baubkus-Gerard, Senior Associate David Rappenglück, As­so­ci­ate Be­ne­dikt Christian Voss, Associate, all Antitrust, Competition & Trade Dr Thomas de la Motte, Partner Dr Markus Pfaff, Partner Dr André Frischemeier, Partner Hatice Aykel, Counsel Alisa Brehm, Senior Associate Thomas Schaak, Senior Associate Dr Sait Dogan, Associate, all Banking & Finance  Dr André Lippert, Part­ner Con­stan­ze Schweidtmann, Associate, both Real Estate & Public Dr Boris Alles, Partner Dr Theresa Kipp, Senior Associate, both Labor, Employment & Pensions CMS France Benoît Gomel, Partner Vincent Desbenoit, Associate Dylan Allali, all Corporate/M&A Caroline Froger-Michon, Partner Aurélie Parchet, As­so­ci­ate Ca­m­ille Baumgarten, Associate Sophie Yin, all Em­ploy­ment Claire Vannini, Partner Eleni Moraïtou, Coun­sel Lilia-Ori­ana Dif, Associate Ariane Rolin, all Competition & EU  Jean-Bap­tiste Thiénot, Partner Anaïs Arnal, Associate, both Intellectual Property Laurine Mayer, Associate, TMC Alexandre Chazot, Counsel, Banking & Fin­ance  Thi­erry Granier, Partner Renaud Grob, Partner, both Tax Arnaud Valverde, Senior Associate, Real Estate Olivier Kuhn, Partner Cécile Rebiffé, Counsel Mylène Garrouste, all Dispute Res­ol­u­tion Kawthar Ben Khelil, Coun­sel Jean-Pierre Malili, Associate, both Public law/In­fra­struc­ture CMS Italy Massimo Trentino, Partner, Corporate/M&A Maria Letizia Patania, Partner, Lifescience & Healthcare Gian Marco Lettieri, Senior Associate, Employment & Pensions Giulio Poggioli, Counsel Valerio Giuseppe Daniele, As­so­ci­ate Francesca Durante, Junior As­so­ci­ate  Arianna Toccaceli, Junior Associate, all Banking & Finance CMS Luxembourg Gérard Maitrejean, Partner Miruna Poenaru, Coun­sel Max­imili­an Helfgen, Associate, all Corporate/M&A CMS UK Jack Letson, Partner Lindsay McAllister, Associate, both Corporate/M&A David Dennis, Partner, Commercial CMS Netherlands Pieter van Duijvenvoorde, Partner Robert Jong, both Corporate/M&A Nigel Henssen Fleur van Assendelft de Coningh, both Employment Edmon Oude Elferink, Partner Marijke van der Vossen, both Antitrust, Competition & Trade CMS Serbia Radivoje Petrikić, Partner Mila Drljević, both Corporate/M&A CMS Austria Dieter Zandler, Partner Vanessa Horaceck, both Competition & EU CMS Ukraine Maria Orlyk, Partner Diana Valyeyeva CMS Turkiye Döne Yalçın, Partner Arcan Kemahlı,  Sa­ba­hat­tin Öztemiz Taner ElmasPress Con­tact presse@cms-hs. com

Stuttgart – The founder of medical laboratory MVZ Laaff, Prof. Helmut Laaff, has sold MVZ Laaff GmbH with its facilities in Freiburg, Heilbronn and Ulm to the amedes Group. amedes is a leading German lab services provider, operating a number of healthcare centres throughout Germany with different specialisations. MVZ Laaff provides services in fields of medicine including derma­to­path­o­logy, general pathology, immunohistology, molecular pathology and cytology, and is one of the leading laboratories in these specialist areas. Details of the transaction were not disclosed.A CMS team headed by lead partner Dr Christoph Lächler advised Prof. Helmut Laaff on all legal aspects of the transaction. The sale took place by way of an auction process. A particular focus of the advice was on structuring the transaction and the associated regulatory issues. CMS Germany Dr Christoph Lächler, Lead Part­ner Stefan-Ul­rich Müller, Partner Dr Jacob Siebert, Partner Viktoria Barthel, Senior Associate Tobias Kalski, Senior As­so­ci­ate An­dreas Kazmaier, Associate, all Corporate/M&A Dr Roland Wiring, Partner Dr Siham Hidar, Senior Associate, both Regulatory Dr Harald Kahlenberg, Partner Angelika Wieczorkowski, Senior Associate, both Antitrust, Competition & Trade Dr Stefan Voss, Partner Lukas Potstada, Counsel, both Real Estate Dr Martin Mohr, Partner, TaxPress Con­tact presse@cms-hs. com

Frankfurt/Main - Die REHA Se­li­genthaler­straße, an ambulatory rehabilitation centre founded in 1995 and based in Landshut, has been acquired by the rehaneo Group, a portfolio company of the Belgian investment company GIMV, as part of a succession agreement with retroactive effect from 1 January 2024. Following the acquisition, rehaneo will continue to operate the facility with all of its 50 employees. With this purchase, rehaneo, a nationwide provider of ambulatory rehabilitation, is strengthening its presence in Bavaria. The parties have agreed not to disclose details of the transaction.A CMS team headed by partner Dr Joachim Dietrich advised the shareholders of the ambulatory rehabilitation centre on all legal aspects of the sale of their shares. Rehaneo was able to prevail in a Europe-wide bidding process. Press Con­tact presse@cms-hs. com

Frankfurt/Main – Össur, Nasdaq Copenhagen listed leading global provider of innovative mobility solutions, acquired all shares of privately owned Fior & Gentz, a Germany based leading European manufacturer of lower limb neuro orthotic components. Fior & Gentz develops and distributes knee and ankle orthotic joints to create innovative custom-made orthotic solutions for patients with gait impairments due to neurological conditions. The acquisition of Fior & Gentz represents an attractive opportunity for Össur to enter the fast-growing neuro orthotics market. The transaction volume amounts to around EUR 100 million plus an earn-out of up to EUR 20 million. The payment consists of cash as well as of newly issued, listed shares of Icelandic Össur hf. to the sellers of Fior & Gentz. An international CMS team led by Dr Heike Wagner and Dr Tobias Kilian advised Össur comprehensively on all legal aspects also in connection with this transaction. CMS Germany Dr Heike Wagner, Partner Dr Tobias Kilian, Of Counsel, both Lead Dr Reiner Thieme, As­so­ci­ate Nath­alie Amrhen, Associate, all Corporate / M&A Jörg Schrade, Partner Eduard Kosavtsev, Senior Associate, both Tax Dr Roland Wiring, Partner Dr Siham Hidar, Senior Associate  Noah Rodenkirchen, Associate, all Regulatory & Lifesciences Dr Stefan Lehr, Partner, Antitrust, Competition & Trade Dr Dirk Smielick, Principal Counsel, IP Prof Dr Malte Grützmacher, Partner, IT Dr Boris Alles, Partner Dela Herr, Associate, both Labor, Employment & Pensions  Dr Franz Maurer, Counsel Wiebke Westermann, Associate, both Real Estate & Public CMS Netherlands Roman Tarlavski, Part­ner Mar­cel­lina Rietvelt, Associate, both Corporate / M&A Martijn van der Bie, Partner Gieneke van Nierop, Counsel, both Corporate / Notaries CMS Norway Nicolas Jorn Brunet, Partner Tuva Svare, Associate, both Corporate / M&A Henrik Nordling, Partner, Antitrust, Competition & TradePress Con­tact presse@cms-hs. com

With big deals fuelling record levels of M&A activity, a steady stream of innovative and disruptive technologies, new and increasingly complex regulatory challenges and a thriving start-up community...

Digital Health Apps/Software 1. How is the software within digital health apps classified in your jurisdiction, and what regulation(s) apply? Software as a medical deviceSoftware within digital health...

We were delighted to bring you this year’s Forum, “Blurring Boundaries - Exploring the convergence of life sciences and law”, from Amsterdam. The theme “Blurring Boundaries - Exploring the convergence of life sciences and law” aimed to:Uncover the latest breakthroughs: Dive into the forefront of life sciences advances, including biotechnology, genetics, pharmaceuticals, and medical devicesAddress the regulatory gap: Engage in interactive workshops to bridge the divide between rapid innovation and the development of legal frame­work­sNav­ig­ate global challenges: Explore the impact of globalisation, ethical considerations, privacy concerns, and societal implications on the life sciences sectorFoster collaboration: Connect with legal and scientific minds, exchange ideas, and build valuable re­la­tion­shipsP­resent­a­tions were delivered by fantastic industry speakers, including Annemiek Verkamman (Managing Director, Hollandbio), Charida Dorder (Member of the Dutch AI Coalition), Wouter Boon (Associate Professor, Utrecht University) and Marc Kaptein (Medical Director, Pfizer), as they shared their expertise, thoughts and insights on how the sector is “Blurring Boundaries”. We were also joined by Simon Neill (Senior Legal Director) at Johnson & John­son and Joep Rijnierse (Senior Medical Director) at Amgen in our workshops. This webpage has been designed to keep you updated on the Forum, our speakers, as well as provide you with the useful resources complementing the theme “Blurring Boundaries - Exploring the convergence of life sciences and law”. You will also find on this page details on how to stay connected with CMS through our upcoming webinar series, On the Pulse Webinar Series 2023 - Autumn (cms. law); free eAlert service, Law-Now; and social media channels.

Hamburg – International commercial law firm CMS has published the DTx Legal Navigator, the first international guide of its kind to placing digital therapeutics (DTx) on the market. It provides practical...

A unique life sciences Forum brought the legal challenges created by the rapid pace of technological advances into sharp focus with sector focused sessions and informative workshops. Experts from across the sector framed the incredible potential from digital and AI and called for the expertise of legal teams to take the ‘’regulatory handbrake’ off innovation that has transformative potential for healthcare systems and patients. CMS’s much-anticipated Global Life Sciences & Healthcare Forum 2023, co-hosted by Ellen Gielen, Roland Wiring and Gertie Lintjens, delivered a wealth of insight and ignited discussion about how regulatory frameworks can be tested and revised without compromising safety, security and compliance. Blurring Boundaries – Exploring the convergence of life sciences and law heard from leading figures from pharmaceutical companies, cutting edge AI enterprises, legal experts and biotech organisations with a strong accent on debate and collaboration. Marc Kaptein, Medical Director, Pfizer, revealed the unchartered territory he and his team had to tread during the pandemic as the company partnered with BioNTech to release a COVID vaccine and maximise its public uptake. In a fascinating talk, he outlined the twists and turns of the inside story of how Pfizer struck a rapid deal with BioNTech by ‘shaking hands’ and then balanced the societal benefits of maximising its vaccination with legal constraints designed to control public promotion.A willingness to break fresh ground legally, politically, scientifically and logistically was an integral part of the success story and he underlined to guests at the Forum, held in Amsterdam, that ‘without blurring boundaries, we would not have got where we are today’. Joep Rijnierse, Senior Medical Director at Amgen, highlighted its pioneering approach to  work closely with patient groups to generate therapy promise across a complete health condition. He said that the company’s medical departments worked with internal and external legal advisers to find ways to manage constraints in the mission to enhance all areas of healthcare delivery to improve systems and outcomes. Legal expertise is critical in shaping the landscape for AI developments and speakers from across the life sciences spectrum underscored the need for regulatory frameworks to evolve at pace. Life sciences is experiencing seismic change and Thibault Helleputte, the Founder and CEO of DNAlytics, revealed that the BioGPT initiative was able to identify medical hypotheses from deep in the data of 15 million papers in PubMed library to give scientists unprecedented R&D leads. The Forum was an opportunity to discuss how legal teams can use their skill and knowledge to ensure that regulatory frameworks did not impede progress and to explore fast and safe pathways for innovations to become working reality. Wouter Boon, Associate Professor in Innovation and Life Sciences at Utrecht University, emphasised the need to place legal aspects at the inception of the innovation process, observing that the sector was ‘highly regulated for all good reasons but it means that radical innovation has a tough job.’The Forum covered an impressive sweep of themes including AI, digital therapeutics, the challenges of multi-jur­is­dic­tion­al online pharmacies, the new EU medicines directive and co-creation with regulators.“We had a great range of speakers who focused on advances and roadblocks across the life sciences sector and provided us all with some innovative and provocative approaches,” said Nick Beckett, Global Co-Head of CMS Life Sciences & Healthcare Sector Group. “It was a fantastic opportunity to discuss, explore and collaborate and the insights and learnings it generated will help us face global challenges in life sciences.“We have to navigate global challenges such as sustainability, poverty, inequality, ageing populations; concerns about privacy with the use of data, concerns about ethics and the use of AI. To do that we need global perspectives and we believe that CMS as a firm, with 80 offices worldwide, is well positioned to navigate issues, foster collaborations and be a vital partner in moving life science innovation forward in the digital age.”