Eveline Van Keymeulen

Eveline's recent experience includes advising:

• A global medical device leader on the US$50 million series D financing round of TriCares, a French medtech startup
• TA Associates on Francisco Partners’ investment in Orisha, a European software publisher dedicated to companies in the retail, real estate, healthcare, construction, and agri-food sectors
• Eurazeo on its contemplated sale of D.O.R.C. for an enterprise value of €985 million
• Inari Medical in its acquisition of LimFlow
• BC Partners, a leading international investment firm, on its exclusive negotiations to acquire a majority stake in Havea, the French leader in natural healthcare serving the European market
• Astorg on its binding agreement to acquire CordenPharma, a leading pharmaceutical contract development and manufacturing organization, from International Chemical Investors Group (ICIG), a privately owned industrial group
• A leading European pharmaceutical industry association on various strategic legal and policy analyses of the EU framework regulating innovation in pharmaceutical product development, including in-depth assessments of personalized medicine, accelerated approval pathways, drug repurposing and unmet medical need, drug-device combination products, complex and virtual clinical trials, innovative manufacturing techniques, the SPC manufacturing waiver, and a variety of other cutting-edge issues that have inspired the EMA Regulatory Science Strategy and the European Commission’s Pharmaceutical Strategy 
• A global pharmaceutical company on the development of a market access strategy for an innovative gene therapy treatment for children in the EU, including advice on early access programs in multiple member states, alternative pricing and reimbursement options for cross-border treatments in Europe and related data protection issues (informed and regulatory consent)*
• Several international pharmaceutical companies on the interpretation of EU regulatory data protection (RDP) rules and strategic life cycle management issues, including advice on the chances of success and procedural pathways for a legal challenge of marketing authorizations granted to fixed dose combination products in the EU and various EU member states* 
• Multiple pharmaceutical companies on the boundaries between commercially confidential information and the mandatory publication (“transparency”) of clinical trial data, including in legal proceedings before the European Courts, as well as on practical implementation questions triggered by the EU Clinical Trial Regulation and possible implications of such transparency requirements on intellectual property rights* 
• Multiple pharmaceutical companies and trade associations on the interplay between regulatory and patent rights, including on enforcement strategies related to second medical use patents and the interpretation of the Bolar exemption in several EU member states, and advising such companies on regulatory strategies and legal arguments in the context of patent litigation and antitrust proceedings and investigations* 
• Successfully defending several specialty pharmaceutical and medical device companies in regulatory, product liability and commercial litigation proceedings in Belgium and France* 
• Successfully representing a pioneering European CBD e-liquid brand in the first referral to the Court of Justice of the European Union (CJEU) related to the marketing of cannabidiol (CBD) based products, the positive outcome of which will have a major impact on the European CBD industry*
• Various global banks, investment funds and European stock exchange companies on the legal and regulatory framework and risk assessment related to investments in medical and well-being cannabis companies in Europe and various EU member states, including advice on the legal and regulatory risks related to the suspension of a listed holding company because of the diversification of its activities in the cannabis industry 
• The world’s leading medical cannabis producers and retailers on navigating the complex regulatory framework and legal pathways to the European market (e.g. advice on medical cannabis pilot programs in several member states, advice on novel food applications in the EU and UK, advice on enforcement practices in different member states), including in the context of acquisitions and initial public offerings 
• A broad range of life sciences actors on health emergency procedures and the regulatory and legal risks and liabilities related to the rapid development and making available of Covid-19 diagnostic tests, including the emergency use of clinical and diagnostic labs, the self-assembly of diagnostic kits by employers, the qualification and validity of different types of testing (including self-tests), and the development of digital solutions to raise public awareness 
• Several consumer electronics, pharmaceutical and insurance companies on the regulatory (medical device) and data protection aspects related to the implementation of digital health platforms and mobile health apps (e.g. symptom checkers, clinical calculators) and on the successful launch and roll-out of such technologies in several EU jurisdictions 
• A leading global online retailer and e-commerce platform on numerous legal and enforcement risk assessments related to the online sale and advertising of an extensive variety of regulated products in key EU member states, including the online sale of medicinal products (and related online pharmacy establishment requirements), diagnostic tests, medical devices, cosmetic products, food and beverages as well as other regulated products 
• A broad range of companies active in the life sciences sector as well as pharmaceutical trade associations on national regulations related to anti-bribery, anti-gift and transparency (“sunshine act”) obligations in various EU member states and related data protection and antitrust questions arising from such regulations 
• A number of well-known cosmetic and food and beverage companies on complex product qualification and borderline questions related to innovative products and associated cosmetic or health claims

*Matter handled prior joining to Latham