Recent experience includes:
A viral vector contract development and manufacturing company
Our life sciences team has specialist experience in relation to the manufacture of biologics, with their increased batch sizes and value, longer production processes and the commercial issues around procuring manufacturing slots associated with the production of large molecule products. We advised on development and manufacturing supply agreements for viral vectors to deliver market-leading cell and gene therapy products as well as commercial supply arrangements for manufacturing suites. Many of these agreements are not governed by English law – we are instructed for our market knowledge.
Otsuka Pharmaceuticals Europe Limited
Advised in relation to a suite of template documents including a master services agreement (including market research), sponsorship agreement, and HCO/HCP agreements.
A biochemistry laboratory
As well as assisting the EMEA legal team in relation to day-to-day workload and data privacy issues, we advised in relation to a number of key outsourcings of business functions, spanning Europe, Asia and Australia. Members of our team have spent significant time with the in-house team and have also assisted the biochemistry laboratory in relation to the potential impact of Brexit on the regulatory framework governing clinical trials in the UK.
Advised on the procurement agreements for the construction of a new biologics plant in Switzerland and on collaborations with Incyte’s partners in various markets, as well as competition issues. Our notable work for Incyte covers advice provided in both the US and Europe and includes the technical operations, commercial and licensing groups.
Advised this cellular therapeutics company on a number of transactions including its manufacturing agreement for its CMD-003 product, which is under development to target malignancies associated with the oncogenic Epstein Barr virus.
We have acted for Oxford Biomedica on a number of agreements relating to the manufacture of viral vectors for gene therapy products at both clinical and commercial manufacture, including with Juno Therapeutics. We also advised on the manufacture of AZD1222, the adenoviral COVID-19 vaccine candidate developed by Oxford University and commercialised by AstraZeneca.
We acted for Novacyt S.A. in relation to the supply of COVID-19 PCR test kits to the Department of Health and Social Care.
We have advised UCB in relation to a number of clinical and commercial supply agreements, as well as a range of business support agreements and the sponsorship of a well-known tennis player to promote one of their products.