As the coronavirus pandemic has moved across the world, Baker McKenzie has leveraged its global footprint to assist numerous clients in their battle against COVID-19. This assistance has covered a range of technologies, including vaccines, treatments, diagnostics and IT solutions.
Advised a global biotechnology company in relation to a broad range of COVID-19 vaccine related matters. This includes a range of licensing, research and collaboration agreements, and supply chain relating to a number of vaccine candidates. We have also assisted with contracts and negotiations with the Australian Government in relation to manufacturing, supply and distribution arrangements.
- Represented a German biopharmaceutical company on its strategic collaboration agreement with a multinational pharmaceutical company for the research, development, manufacturing and commercialization of five mRNA-based vaccines and monoclonal antibodies targeting infectious disease pathogens.
- Advised a multinational pharmaceutical company on export controls in connection with its COVID-19 vaccine project.
- Advised a major pharmaceutical company in the preparation of the relevant contracts and negotiations with the Brazilian government covering the sales of drug substance and technology supply for the production of a finished COVID-19 vaccine in Brazil. We have also assisted in the clinical trials documents for the studies in Brazil.
- Advised a major transportation company about the regulatory requirements for transportation of vaccines to and from Brazil.
- Advised a global pharmaceutical company on market access and regulatory and stakeholder engagements arising from a potential launch of a COVID-19 vaccine in a Southeast Asian jurisdiction.
- Advised a multinational pharmaceutical company in structuring vaccine contracts for the local production of its COVID-19 vaccine and assisted with the regulatory approval of its related clinical trials.
- Advised a European biopharmaceutical company on an R&D agreement with a university to develop an mRNA-based COVID-19 vaccine.
- Advised a global commercial-stage biotechnology company in its exclusive license agreement to develop, manufacture and commercialize investigational anti-COVID-19 antibodies globally outside of greater China.
- Advised a leader in critical care immunotherapy in multiple agreements enabling the use of its medical device to treat critically ill patients with COVID-19 infection in China and the United States.
- Advised a global biopharmaceutical company on US Coronavirus Aid, Relief, and Economic Security (CARES) Act and Biomedical Advanced Research and Development Authority (BARDA) funding applications for development of a plasma-derived therapeutic for COVID-19.
- Assisted a hospital to fight off an irregular order issued by the health regulator prohibiting it from offering convalescent plasma treatment.
- Assisted non-healthcare foreign companies, who had manufacturing plants in Mexico, re-purposing part of their operations to temporarily produce personal protection equipment for their employees or for donating them to local health institutions.
- Developed a framework intellectual property license agreement that allowed a government institution to run a competition identifying ventilator manufacturers in developing countries.
- Advised a merchandizing display manufacturer on various aspects of establishment and product licensing, as well as related IP issues, to accommodate their pivot to the manufacture of devices useful in the treatment of COVID-19.
- Advised various companies on PPE-related matters, including EUA process and related import/export issues.
- Advised a global consumer healthcare company on its collaboration to develop a rapid, handheld CRISPR-based test to detect active COVID-19.
- Conducted a multijurisdictional survey on the rules around PCR testing for a multinational medtech company.
- Advised a diagnostic company in a massive sale of diagnosis test for Covid-19 to the Brazilian government - more than 30 million tests, with rental of 30 large processing equipment.
- Our Canadian life sciences attorneys advised on the revision to various clinical trial agreements on protocols to address the impact of COVID-19 for global clients.
- Our life sciences team in Mexico advised several foreign biotech companies regarding registration of their rapid genetic tests for COVID-19, using the emergency and provision regulatory pathway for rapid tests during COVID-19.
- Advised a non-healthcare company identifying how to import a thermal camera for non-invasive temperature monitoring purposes at the place of work.
- Advised various companies in the US and Europe on the regulatory requirements for the export of personal protective equipment and COVID-19 test kits and conducted verifications on product registrations and manufacturing licenses.
- Provided pro bono advice on the data privacy, intellectual property and commercial law aspects of Pinterest's mobile app, How We Feel, which helps doctors and scientists gather data about COVID-19. Find out more.
- One of the six organizations supporting telehealth organization NHS 24, on the launch of an online chatbot which will give people across Scotland access to help and information about COVID-19. Find out more.
- Assisted an IT platform to offer telemedicine services for COVID-19 triage purposes.
About Baker McKenzie's Healthcare & Life Sciences Group
As one of the first law firms to advise life sciences companies on their global expansion 60 years ago, our deep knowledge in the industry, honed over the past six decades, is rooted in our corporate DNA. Our group is one of the largest of any international law firm, comprising over 800 lawyers in 47 countries, including in the top 10 largest healthcare and life sciences markets in the world.
Our client base comprises big pharma, biotech, medical device companies, medtech and digital health companies, CROs, healthcare information providers, hospital systems, universities, non-profit institutions, veterinary drug companies and other service providers/companies in the life sciences and healthcare ecosystem. We have worked on a broad range of products and breakthroughs for clients. This includes complex collaboration and strategic alliance structures for new technologies, drugs, biologics, biosimilars and devices; in areas such as nanotechnology, cell and gene therapy and editing, vaccines and other drug development, as well as medical foods, dietary supplements, and other consumer products that are regulated by the FDA, EMA and other authorities.
The firm is ranked among the top 10 Law Firms in the world for Life Sciences in Chambers Global, is ranked Band 1 for Life Sciences in Chambers Asia Pacific and is ranked Band 1 Mexico: Life Sciences in Chambers Latin America. The firm is recommended for Licensing & Collaboration by LMG Life Sciences, is recognized as the LMG Life Sciences Firm to Watch in Financial and Corporate in 2019 and the LMG Life Sciences Regulatory Firm to Watch in 2020. (www.bakermckenzie.com)