1. Clinical Trials Contracting Issues: Managing the Outsourced Relationship Linda D. Bentley, Esq. May 18, 2007

2. First Steps Consider reason for outsourcing Research potential contractors Consider relationship with contractor Draft term sheet

3. Parties Clinical Site Contract Research Organization (CRO) Contract Manufacturer Clinical or Imaging Laboratory Data handler

4. Agreements Identity of parties Definitions Applicable laws Ownership and use of data Confidentiality Indemnification Insurance Representations and warranties Post-termination requirements

5. Clinical Sites Parties –Institution and/or Investigator Ownership and use of data –Clinical results –Intellectual property –Informed consent and HIPAA authorization Indemnification and allocation of risk –Mutual or one-way –Limit to third-party claims –Treatment of injury to research subjects Applicable law and standards of practice

6. CRO Scope of services Delegated authority Staffing changes Location of services Indemnification

7. Contract Manufacturing Applicable standards Ownership and use of manufacturing procedure and IP Transfer of and continued access to technology Changes to procedures or specifications Indemnification and insurance Limitation of liability Warranties

8. Data Handling and Analysis License agreement Term

9. The Message Give careful thought to the purpose and nature of the relationship Be clear about what you expect Identify potential problem areas and address them before the work begins

10. Linda D. Bentley, Esq. One Financial Center Boston, MA 02111 (617) 348-1784 LDBentley@Mintz.com