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.
Advised this FTSE250 gene and cell therapy company on a number of transactions including:
- on the new three year Master Services & Development Agreement with AstraZeneca UK Ltd, which would facilitate potential future manufacturing opportunities for the AstraZeneca COVID-19 vaccine.
- a licence and supply agreement with Arcellx, Inc. for LentiVector® Platform for CAR-T Therapeutics.
- the manufacture of AZD1222, the adenoviral COVID-19 vaccine candidate developed by Oxford University and commercialised by AstraZeneca.
- a licence and clinical supply agreement with Juno Therapeutics, a Bristol-Myers Squibb company. The agreement granted Juno Therapeutics a non-exclusive licence to Oxford Biomedica’s LentiVector® platform for its application in CAR-T and TCR-T programmes in oncology and other indications, and additionally put in place a five year Clinical Supply Agreement, which may be extended further. Oxford Biomedica received an upfront payment of $10 million in cash and the agreement provides for the potential of up to an additional $86 million to be payable to Oxford Biomedica upon achievement of certain development and regulatory milestones related to multiple products and indications; up to $131 million in sales-based milestone payments and an undisclosed royalty on the net sales of products sold by Juno Therapeutics utilising the LentiVector® platform.
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.