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07 Dec 2021

Life sciences A to Z - C is for collaboration arrangements

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This month we are exploring, at a high-level, the use of collaboration agreements in the life sciences sector, and some of the issues to consider.  As we develop our A-Z series we will then do a deeper dive into some specifics – there are a wealth of topics available to us here!

Projects in the life sciences sector invariably involve contributions from multiple specialists and experts: 3-D printing is enabling more specific prosthetics; medical devices are improving drug delivery and AI/software is increasingly used to improve research capacity, drug discovery and patient treatments. Given the breadth of specialist knowledge required, collaboration arrangements help specialists combine knowledge. The agreements governing such arrangements are complex and often heavily negotiated.

Starting point: Some research institutes and academic institutions have their own template agreements protecting their preference for publication rights and research licences. For example, the Lambert Toolkit is freely available at .gov.uk and is often used as the starting point by academic institutions. Other public bodies, like the National Institute for Health Research also provides freely accessible model research collaboration agreements. The approach to collaboration agreements can differ significantly depending on whether one party is an academic or publicly-funded institution, and the other is a commercial party. This is a key challenge to navigate when the parties are collaborating together.

Contributions: In a collaboration the parties need to agree on what they will contribute as well as what will be done with any inventions and discoveries coming out of the collaboration. In some cases, the arrangement may be "fee for research" in which case one party contributes funding for the project whilst the other party focusses on R&D. In other cases, each party may contribute its own proprietary technology and IP for use in the project, as well as key personnel.

IP ownership and licences

Parties contributing IP to collaborative projects will need to grant each other licences to their background IP to enable each party to carry out its contribution activities. The trickier question is deciding what happens to any IP that is created as part of the collaboration and then ensuring that the consequences of such decision are addressed:

  1. Will the collaboration IP be assigned to one party?
  2. Will the other parties be permitted to use the collaboration IP? If so, to what extent? For research only, or for the purpose of commercialisation?
  3. Will the collaboration include an option to obtain an exclusive licence depending on the results of the collaboration?
  4. Will the collaboration IP be jointly owned, and how will that be managed?

In any case, parties should brainstorm scenarios to ensure that the documents are as future-proofed as possible and to ensure they have, and will retain, the necessary licences to pursue future activities.

Other key issues: Other key areas to consider in a collaboration agreement include:

  • What is the precise scope of the collaboration?
  • What efforts and resources are each of the parties required to contribute?
  • Is a tech transfer required?
  • What are the regulatory implications of the collaboration and who is responsible for engaging with the regulators?
  • Are there any data protection implications?
  • What is the Term of the collaboration, and in what circumstances can the collaboration be terminated?
  • If a collaboration is terminated, what are the consequences for the collaboration IP
  • Are there any competition law issues that arise?

Collaboration agreements can be a great way to further research, parties just need to ensure the arrangements are considered in full to protect their present and future interests.

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