A proposal for the modernisation of the Dutch Patent Act (Rijksoctrooiwet 1995) is currently under consideration by the Parliament. In this article, we briefly outline the most important implications for the Dutch life sciences sector and, in particular, for university spinouts.
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Food and Feed
Medical Devices
Pharmaceuticals
Due Diligence
Testimonial
Axon regularly acts as a sub-contractor for leading international firms to assist in regulatory due diligence in our fields of expertise: pharma, medical technology and food.
Biotech
Food and Feed
Due Diligence
Regulatory Compliance and Enforcement
Testimonial
Axon assisted a French VC company investing in a food tech start-up. We reviewed the target’s regulatory strategy under the EU novel foods framework, assessed its feasibility and outlined potential risks and how to mitigate these.
Medical Devices
Regulatory Compliance and Enforcement
Spin-out and Starter Advisory
Testimonial
We have advised a start-up on enforcement actions brought by the Dutch Healthcare Inspectorate (IGJ) concerning MDR compliance.
Diagnostics
Food and Feed
Commercial Contracts
Intellectual Property and Licensing
Spin-out and Starter Advisory
Testimonial
Axon assisted a start-up developing a real-time diagnostic test to define pathogens food. We negotiated and drafted an agreement with a university to support the further development & validation of the technology.
Agriculture
Biotech
Food and Feed
Regulatory Compliance and Enforcement
Spin-out and Starter Advisory
Testimonial
As a partner of StartLife, Axon assisted a feed company with the regulatory qualification of its technology. Our reasoned opinion serves as a key document for the company’s funding activities.
Subsidies and Grants
Testimonial
We have advised several clients, including Dutch Growth Funds, on the structuring and application of government funding and related public-private partnership schemes aimed at stimulating innovation in the life sciences and health sector. Our advice covers the design and structuring of funding schemes, including the formulation of eligibility criteria and subsidy conditions, the establishment of governance frameworks for public-private consortia, and the administrative and legal requirements for the disbursement of government-funded research and development grants.
Due Diligence
Testimonial
Axon regularly provides specialist due diligence support on a variety of corporate transactions in the life sciences sector.
Medical Devices
Data Protection, (Cyber)security and AI
Due Diligence
Regulatory Compliance and Enforcement
Testimonial
We have conducted regulatory due diligence on behalf of a private equity firm in connection with the acquisition of a medical device manufacturer, covering MDR compliance (including notified body certificates and post-market surveillance obligations), as well as data protection aspects.
Healthcare
Pharmaceuticals
Due Diligence
Regulatory Compliance and Enforcement
Testimonial
We have conducted regulatory due diligence in connection with the acquisition of a pharmacy, covering compliance with applicable pharmaceutical and healthcare legislation.