THE CONTRACTING PROCESS: AN OVERVIEW

1
THE CONTRACTING PROCESSAN OVERVIEW

• Jean R. Gabeau, Esq.
• Manager of Contracts
• Clinical Trials Office
• Columbia University Medical Center

2
OVERVIEW

• Presentation
• Types of documents negotiated
• Pre-negotiation process
• Negotiation process
• Clinical Trial Agreement provisions
• QA

3
TYPE OF DOCUMENTS NEGOTIATED

• Confidentiality Agreements
• Clinical Trial Agreements
• Master Agreements
• Subcontracts
• Material Transfer Agreements
• Contract Amendments
• Study Close Out Documents

4
SCOPE OF CTO RESPONSIBILITY

• A funded clinical trial (including
  investigator-initiated funded by NIH,
  foundations, or industry).
• PI must have primary appointment within the
  College of Physicians and Surgeons.

5
CONFIDENTIALITY AGREEMENTSAlso known as Secrecy
Agreements, Non-Disclosure Agreements, or
Confidentiality Disclosure Agreements (CDA)

• The general purpose of a confidentiality
  agreement is to facilitate the release of
  confidential and proprietary information and to
  ensure that such information is kept confidential.

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RECEIPT OF SUBMISSION

• Submissions to the Clinical Trials Office
• www.columbiaclinicaltrials.org

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THE CONTRACT PROCESS

• Upon full submission to the Clinical Trials
  Office, the assigned contract reviewer will
  contact the Sponsor.
• The contract reviewer then reviews and revises
  the contract and then forwards the revised
  document to the Sponsor for review and
  consideration.

8
THE CONTRACT PROCESS CONTINUED

• Special considerations revisions to contracts
  with new Sponsors must first go to Columbia
  Universitys Office of General Counsel for
  review.
• Device trial agreements must first go to the
  Hospitals Procurement office before submission
  to the Sponsor.
• The Sponsor will review Columbias contract
  revisions.
• Both sides will negotiate until an agreement is
  reached on the legal terms.
• The final agreed upon legal provisions are
  combined with the finalized budget terms.

9
THE CONTRACT PROCESS CONTINUED

• The contract is routed for signature to the PI,
  Institutional signatories and Sponsor.
• The fully executed agreement is forwarded to the
  Finance Department for account set up.

10
PUBLICATION RIGHTS

• University Mandate
• No unreasonable restrictions on the right to
  publish.
• Goals
• Complete, Unobstructed Right to Publish
• No Sponsor Control over Presentation of Research
  Results
• Minimum Publication Delays

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EXAMPLE OF RESTRICTIVE PUBLICATION PROVISIONS IN
A SPONSORED RESEARCH
12
INDEMNIFACTIONDefinition To make good,
make whole or reimburse a loss, liability or
damage incurred by another.

• Scope, Exceptions, one way Indemnification versus
  Mutual Indemnification
• Emergency Medical Care
• Insurance

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CONFIDENTIAL INFORMATION

• Previous Discussion Regarding Terms of a CDA
  Apply Here (Definition, Term, Exceptions)
• Avoid Conflict with Publication Section

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INTELLECTUAL PROPERTY

• Sponsor Initiated Trials
• Discovery made in Direct Performance of the
  Protocol versus Discovery Outside the Scope of
  the Protocol
• Royalty Free License to use Inventions Arising
  from the Study
• Case Madley v. Duke University
• 307 F 3d 1351 (2002)

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MISCELLANEOUS

• Breach of Contracts
• Material Breach
• Cures
• Payment and Fee Provisions

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CLINICAL TRIAL OFFICE
CONTRACTS DIVISION CONTACT LIST