1. Contracts: Negotiations and Key Elements Belinda Vandersluis Operations Director, NCIC CTG

2. “I am not a lawyer” This presentation is not the same as seeking legal advice We recommend you consult with a lawyer if you want professional assurance that our information, and your interpretation of it, is appropriate to your particular situation.

3. Contracts: Negotiations and Key Elements Objectives: –Understand the importance of detailed review of contracts and agreements –Have a basic understanding of commonly included legal terms in contracts and agreements –Understand the fundamentals of negotiating skills

4. Acronyms CAHO –(Council of Academic Hospitals of Ontario) CURIE –Canadian University Reciprocal Insurance Exchange HIROC –Healthcare Insurance Reciprocal of Canada CMPA –Canadian Medical Protective Association

5. Contracts Primer Types of agreements –Confidentiality or Non Disclosure –Participating centre agreement For multi centre clinical trials General and trial specific –Investigator agreement –Sponsor agreement –Services agreement –Material transfer agreement

6. Contracts Primer Parties to the agreement –Institution –Investigator –Company OR Other partner Academic sponsor (cooperative group) Sub contractor (“for profit” CRO) Service provider (lab for correlative studies) Another institution

7. Contracts Primer Authority to contract –Have your institution review agreements –Ensure you have the right to sign the agreement –Third parties

8. Selected Provisions Intellectual Property Publications Indemnification Medical Care of Clinical Trial Participants (in the event of an adverse consequence)

9. Intellectual Property Inventions –Ownership –Licensing –Joint inventions Data –Copyright –Databases Administration of Intellectual Property Remember to balance with the probability of new invention

10. Publications Right to publish the results of study Other rights to discuss study (e.g. at meetings or conferences) Notification to sponsor –Prior to submission –“Approval” of sponsor defined –Removal of information or delay in publication for submitting patents

11. Indemnification Who indemnifies and who is indemnified? –Investigators with CMPA –Expenses of claim Insurance

12. Medical Care of Subjects Subject injury –Costs –Compensation for injury –Routine medical care costs

13. Emerging Issues Billing, costs and overhead Institution and Sponsor policies and procedures Governing Laws and provincial restrictions

14. Hot Risk Management Issues Insurance (CURIE / HIROC) –Warranties –Indemnification –Insurance and CMPA –Medical Care for Research Participants Principal Investigator signature on a contract Confidentiality / Publication Rights Privacy

15. Negotiations Know the parties –Your institution, associated lawyer(s) –Sponsor (industry or academic, int’l or domestic?) –Third parties to the agreement (e.g. sub contracts) Know the study –You may need to explain risks, drugs, etc. to parties Must have’s vs Nice to have’s Negotiation style –Industry vs academic –International issues such as culture

16. Negotiations Who will negotiate terms? –Will investigator be involved? –When do you hand it over to your institution and/or lawyer? –How do you want to remain involved? Who will negotiate budget? –When do you “lose control”?

17. Negotiations Set timelines for review, based on real deadlines (e.g. 1 st pt on study) –Some REB’s require a signed contract with budget to be attached to REB submission Provide study summary including risks to any reviewer Use CAHO, or other like principles, when negotiating with industry

18. Acronyms CAHO –(Council of Academic Hospitals of Ontario) CURIE –Canadian University Reciprocal Insurance Exchange HIROC –Healthcare Insurance Reciprocal of Canada CMPA –Canadian Medical Protective Association