Lambert tool kit - Model Research Collaboration

Lambert Tool kit
The Lambert toolkit is for universities and companies that wish to undertake collaborative
research projects with each other.
The toolkit consists of a set of five Model Research Collaboration (one to one) Agreements
numbered 1-5 and four Consortium (multi-party) Agreements lettered A-D and documents
that should help you to use and understand those agreements. The toolkit was prepared by
the Lambert Working Group on Intellectual Property.
http://www.ipo.gov.uk/lambert
PLEASE TICK THE BOXES THAT APPLY
1. Has the Project been commissioned by the Sponsor?
2. Is the Project critical to the Sponsor's technology acquisition /development strategy?
3. Does the Project rely substantially on the Sponsor's proprietary materials or Background IP?
4. Would the Project be difficult or impossible to carry out without privileged access to the Sponsor's proprietary materials or Background IP?
5. Is the focus of the Project the testing or analysis of the Sponsor's proprietary materials, or research based around the Sponsor's materials
or Background IP?
6. Has the Sponsor taken the lead in designing the workplan for the Project?
7. Is the Sponsor setting deliverables and/or milestones for the Project?
8. Can the Project be ring-fenced from the Principal Investigator's (PI) other research activities?
9. Is the Sponsor's ownership of resulting IP irrelevant to the PI's future research (i.e. there will be no knock-on effect on the PI's other
research or related IP rights)?
10. Is the Sponsor paying FEC plus profit?
POSSIBLE OUTCOMES
YES
POSSIBLE OUTCOMES
0 - 2 "Yes" answers
It looks as though Model Agreement 1, 2 or 3 is the most suitable for your purposes. Please go to Section 3 to consider whether to use Model
Agreement 1, 2 or 3.
3 - 4 "Yes" answers
It looks as though Lambert Model Agreement 1, 2 or 3 is the most suitable for your purposes, but the situation is not absolutely clear and you
may wish to reconsider some of your answers. Please go to Section 3 to consider whether to use Lambert Model Agreement 1, 2 or 3.
5 "Yes" answers
The position is evenly balanced and we cannot recommend which of the Lambert Model Agreements most closely fits your needs. You may
wish to reconsider some of your answers. Answering the Additional Questions may help to clarify things.
6 - 7 "Yes" answers
It looks as though Lambert Model Agreement 4 or 5 is the most suitable for your purposes, but the situation is not absolutely clear and you
may wish to reconsider some of your answers. In any case you should consider whether the University needs to use the Results for academic
purposes. Please go to Section 2 to consider whether to use Lambert Model Agreement 4 or 5.
8 - 10 "Yes" answers
It looks as though Lambert Model Agreement 4 or 5 is the most suitable for your purposes, but you should consider whether the University
needs to use the Results for academic purposes. Please go to Section 2 to consider whether to use Lambert Model Agreement 4 or 5.
Model Agreements
Before a piece of research can start, sponsors and host institutions need to have appropriate
agreements in place. Considerable time and effort can be required to draft different versions
of such agreements for the various research scenarios. To simplify this process, the UKCRC
Partners and stakeholders have developed a suite of model agreements which can be used
"off the shelf", without modification.
The 2011 versions have been revised to include the definitions of an 'agent' and to take into
account the introduction of the Bribery Act 2010. Further details of these changes can be
found here on the NIHR website.

Commercial Collaborative Research
Report of a workshop on the development of model agreements for commercial
collaborative research

mNCA and downloads
Model agreement for non-commercial research in the Health Service developed
under the UKCRC umbrella through a consultative process.

mCTA and downloads
Model agreement for pharmaceutical industry-sponsored trials in patients in NHS
hospitals throughout the UK.

Devices mCIA and downloads
Model Clinical Investigation agreement for company-sponsored commercial research
involving medical devices in patients in hospitals throughout the UK health service

CRO mCTA and downloads
Tripartite agreement between a pharmaceutical company sponsoring a trial, the CRO
managing it and the NHS organisation where the trial takes place.
http://www.ukcrc.org/regulationgovernance/modelagreements/
model Industry Collaborative Research Agreement (mICRA)
The model Industry Collaborative Research Agreement is designed to support clinical
research collaborations involving the pharmaceutical and biotechnology industries, academia
and NHS organisations across the UK.
The model Agreement is supported by a comprehensive Guidance Document which sets out
its background and aims and details how the Agreement should be used in the development
of contracts for specific clinical research collaborations.
A Decision Tree is also available to guide users in identifying when studies are collaborative
and whether mICRA is applicable. The Agreement has a choice of options for clauses
covering Intellectual Property arrangements and the Decision Tree guides users through this
process.
The model Industry Collaborative Research Agreement was developed by a working group
led by the NIHR Office for Clinical Research Infrastructure (NOCRI) and the Medical
Research Council. Representatives from industry, universities and the NHS, and the
Intellectual Property Office, were brought together with expert legal opinion to develop a
model Agreement that can be used to support all collaborative research scenarios.
Organisations involved in the working group have agreed a Statement of Endorsement
encouraging widespread use of the model Agreement to streamline the contracting process
for collaborative research.
See press release for information on launch of mICRA
Downloads
mICRA Template contract
pdf
mICRA Guidance
pdf
mICRA Decision tree
pdf
Statement of endorsement
pdf
Word
Feedback on your experience of using this template agreement is welcomed and will be used
to inform its future development. Please email any comments to [email protected]
http://www.nihr.ac.uk/infrastructure/pages/micra.aspx