1. Contracting Considerations in Research & Innovation
R&D Forum, 6 May 2015
Dr Karen Underwood
R&D Senior Contracts Manager
University Hospital Southampton NHD Foundation Trust

2. Clinical Trial Contractual Arrangements
CDA MTA
CTA DTA
Sponsor Trial Site Sponsor
Commercial Trials
Non-Commercial Trials
Investigator Initiated Trials

3. Commercial Trials
CDA
One Way – protect sponsor Confidential Information
Term
Survival of confidentiality obligations
Law / jurisdiction IP
FOIA / law
Liability / injunctive relief

4. Commercial Trials CTA Model with amendments Often non-UK sponsor
Research governance
Indemnity
Equipment
Clinical trial subjects
MTA + template
DTA + template

5. Non-Commercial Trials
CDA – often not put in place
CTA
US / Non-UK Sponsor
Research governance / terminology
FDA requirements for investigators
Funding conditions
Law/jurisdiction
Indemnity / insurance
Data Protection
Human Tissue

6. Non-Commercial Trials
Collaboration Agreement
Compatible with grant funding
IP – ownership, access and commercialisation
Responsibilities
Site agreements reflect terms of collaboration agreement

7. Material Transfer Agreement
Need to ensure recipient complies with:
Patient consents
Protocol
Ethical Approval
Human Tissue Act

8. Data Transfer Agreement
Data transfer outside EEA
8th Principle of data protection act
Is it personal data
Is the country recognised by EU as having adequate protection?
US – on safe harbour list?
Technical measures?
model contract clauses?

9. Investigator Initiated Trials
Grant Contract
Funding terms and conditions
IP Ownership & Commercialisation
Data Access
Publication / Publicity
Acknowledgement
Notification

10. Investigator Initiated Trials
CTA with company not sponsor
Funding / product
IP ownership
Data access
Indemnity for product
Acknowledgement
Conflict of interests
Compatability with grant contract

11. National Initiatives R&D Forum HRA Approval Model Agreements - suite
Guidance on CDA
Model CDA
HRA Approval
Model Agreements - suite

12. Questions ??