Strategic transactions: licensing, R&D, supply chain, and other strategic alliance agreements
Over the past 15 years, we have built robust partnerships with the legal departments and R&D, supply chain and BD business units of some of the finest (multinational) pharma, biotech, and MedTech companies, for the drafting and negotiation of strategic transactions. These transactions include (in- and out-) license agreements, R&D collaboration agreements, co-development agreements, tech transfer agreements, (co-)investment and long-term capacity reservation agreements, drug substance and drug product manufacturing agreements, EPC(M) agreements, asset and share purchase agreements, and divestment agreements.
These partnerships have provided us with unique insights into the intricacies of product life cycle management, and the complexities of operational processes underlying the development, manufacture and commercialization of medicinal products and medical devices.
This expertise and our genuine interest for each of our clients’ business strategies, allow us to rapidly grasp the legal and business complexities of a transaction and translate these pragmatically into solutions that are mutually beneficial for all parties involved.
Recent work highlights
- For a multinational pharmaceutical company, we have negotiated the contractual agreements to enable the company to secure capacity for the company’s supply chain in a truly novel way. In doing so we are challenging the status quo of the traditional capacity reservation models with CDMOs.
- During the Covid-19 crisis, we have provided contractual and transactional support to a multinational pharmaceutical company for the scaling up of the company’s manufacturing capacity to enable the company to reach its goal of having capacity available for a global supply of a its vaccine. The provided support consisted of the drafting and negotiating of the underlying agreements (technology transfer agreements, capacity agreements, manufacturing & supply agreements, etc.) with various suppliers, contract manufacturing organizations and other pharma companies throughout the world against the expedited timelines of the development of a vaccine and the on-going Covid-19 crisis.
- For a fast-growing, diversified surgical ophthalmic business, we have assisted with the exclusive in-licensing of intellectual property related to a single use endoscopic probe (delivers illumination, laser treatment and means of direct visualization) and an integrated console and display (to power the laser and illumination and enable image capture).
- For a company specializing in the research and development of polymers for therapeutics, etc., we have assisted in the transfer of the majority of its assets and the out-licencing of its technology to a company specialising in the design, development and end-to-end GMP manufacturing of polymer and lipid-based drug delivery systems for cell and gene therapy and vaccine delivery.
- For a US venture capital firm, Quinz has been appointed to lead the negotiations and related transactional documents (material and data transfer agreements, funding agreements, etc.), and to advise on the appropriate legal structure for a new EU-funded consortium with the goal to establish a novel European biobank and accompanying data platform for accelerating biomarker discovery and validation to support therapeutics development for neurodegenerative diseases.
Global and regional compliance projects and multi-country regulatory services
Ensuring healthcare compliance and data privacy is not just a matter of meeting regulatory standards; it’s essential for building the company’s credibility with patients, healthcare practitioners, and authorities. We assist clients in establishing comprehensive compliance projects, whether on a global or regional scale, to ensure that the company adheres to applicable compliance standards. Our approach involves crafting clear, step-by-step roadmaps tailored to the company’s specific needs, addressing priority areas, and developing robust (new) standard operating procedures (SOPs), processes and contracts. We identify and assist in the remediation of compliance gaps as they emerge. To support the implementation of our clients’ compliance framework, we offer customized training sessions for employees and management, along with permanent training materials for ongoing internal education.
We also provide the necessary resources to review communications materials before they are released to the public.
Our team is often called upon to serve as a centralized point of contact for life sciences companies requiring multi-country regulatory services. This includes conducting comparative cross-country surveys on specific regulatory topics. To meet the diverse needs of our clients, we work with a network of associated partner firms to assist with these requests.
Recent work highlights
- For a US-based biotech company focusing on rare genetic (muscular) diseases, we have helped the company build its European compliance organization from the ground up. This included designing and drafting internal policies and SOPs, conducting compliance training for relevant staff, reviewing company communications materials, and creating standard templates for the company’s core European market for interactions with healthcare professionals.
- For a biotech company, Quinz conducted a cross-country compliance/regulatory survey (Belgium, Finland, Italy, Poland, Spain, UK) on available options to offer post-trial access to one of its investigational drug products.
- Quinz has advised a biopharmaceutical company, focused on the development and commercialization of diagnostic and therapeutic products based on radiopharmaceuticals, on various regulatory and compliance matters in preparation for the launch of its products into the European market. In collaboration with other firms in the relevant EU member states, our team has advised on matters related to market access, early access, drug product qualification, magisterial compounding, hospital exemption, etc.
- For a MedTech multinational specialized in implantable devices we performed a multi-country analysis throughout the EU Member States on the validity of patient and surgeon testimonials on social media about their experiences with client’s products.
- For a multinational biotech company focusing on rare genetic (respiratory) diseases, we have helped the company ensure that its communications materials comply with applicable standards. As part of the client’s internal communications review committee, we review international and local materials about the company, its products, areas of interest, and activities to be disseminated through a variety of channels (social media, newspapers, congresses, websites, brochures, etc.).
