Industry Research Agreement Process Summary

SUMMARY OF ORC INDUSTRY FUNDED RESEARCH CONTRACT PROCESS

1)            Upon ORC receipt of a contract or request for ORC to draft a contract, an ORC Agreement Manager will send an email to the PI and, as applicable, either the CRU FPM+RPM, or Dept. Business Manager/Grants Manager that: 1) notifies the research team that ORC has the contract/contract request and that ORC will begin review and negotiation or drafting; 2) asks who on the research team should be notified of contract related developments (ex. PI, other POCs, (the relevant CRU RPM and FPM will be included on all material correspondence)) (the “Study Contacts”); 3) informs them that the Study Contacts can expect a contract status update email upon the occurrence of a significant contract event; 4) notifies them that if they have any questions, issues, or comments regarding the contract or its status, to please contact the ORC Agreement Manager; and 5) asks several questions that will facilitate ORC’s  review of the contract , including if any Duke background IP, or Duke spin out technology, will be used by Duke to conduct the activities.

2)            ORC Agreement Managers will send a contract status update to the Study Contacts upon the occurrence of a significant contract event.

3)            ORC Agreement Managers will in all contract negotiations seek to use a Master Agreement, language or templates previously agreed upon by the other party, or the ACTA (Accelerated Clinical Trial Agreement).  The Agreement Manager will use the ORC Contract Negotiation Guide to aid resolution of contract language issues. 

3)            At a time when ORC has been negotiating a contract for the earlier of 45 days, or two negotiation cycles, the Agreement Manager will discuss the contract status with their Director to determine what action can be taken by ORC to move the contract forward.  If contract issues remain at 55 days, the Director will escalate the issues to the Executive Director.

4)            Upon finalization of ORC contract negotiations, ORC Agreement Managers will send an email to the Study Contacts notifying them that either 1) the contract cannot be sent for signature because of an “On Hold” event and that the contract cannot be sent for execution until the On Hold event is cleared (“On Hold” usually means the Budget or SOW have not been approved by the Dept. or CRU, or the protocol has not been submitted in the Duke IRB); or 2) the Agreement Manager has submitted the contract to the ORC responsible party (Cory Puryear) for signature and that if the Study Contacts have any questions or issues from that point on, they should contact Cory Puryear at ORC_Industry_Contracts@dm.duke.edu.

NOTES: ORC contract negotiation begins upon receipt of sufficient information to begin the negotiations - the ORC Manager must be able to determine who the parties are and what the scope of work is. Generally expected maximum contract negotiation timelines are, as measured in business days:

  • 5 days for ORC’s first action to negotiate the contract (gather information, draft contract or redline)
  • 7 days to respond to other party’s redlines/emails etc.
  • 14 days for other party to reply to a Duke draft or redline after which time the Agreement Manager will contact the other party for a status update.  Can increase frequency if the project is  high priority.
  • 45 days, or two review cycles, whichever is earlier, any open legal terms and conditions escalated from the Agreement Manager to the Director.
  • 55 days – any open contract issues escalated to the ORC Executive Director.
  • 60 days – all legal terms and conditions resolved.