Transcript Contracts: Negotiations and Key Elements

Contracts:
Negotiations and Key Elements
Belinda Vandersluis
Operations Director, NCIC CTG
“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.
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
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
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
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
Contracts Primer
• Authority to contract
– Have your institution review agreements
– Ensure you have the right to sign the
agreement
– Third parties
Selected Provisions
• Intellectual Property
• Publications
• Indemnification
• Medical Care of Clinical Trial
Participants (in the event of an adverse
consequence)
Intellectual Property
• Inventions
– Ownership
– Licensing
– Joint inventions
• Data
– Copyright
– Databases
• Administration of Intellectual Property
• Remember to balance with the probability of new
invention
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
Indemnification
• Who indemnifies and who is
indemnified?
– Investigators with CMPA
– Expenses of claim
• Insurance
Medical Care of Subjects
• Subject injury
– Costs
– Compensation for injury
– Routine medical care costs
Emerging Issues
• Billing, costs and overhead
• Institution and Sponsor policies and
procedures
• Governing Laws and provincial
restrictions
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
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
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”?
Negotiations
• Set timelines for review, based on real
deadlines (e.g. 1st 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
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