Using This Checklist
The purpose of this checklist is to
help you analyze Sponsor-offered clauses in order to determine what editing they
require to bring them into conformance with the Regents' Rules regarding
intellectual property. If you have not yet offered the Sponsor a standard agreement,
or if that is not acceptable to the Sponsor, our standard clauses as substitutes
for particular Sponsor-offered clauses, you should do that first before attempting
to edit Sponsor-offered clauses.
Each section below summarizes the
important features or concepts to look for (or in some cases, to avoid)
as you analyze a contract clause that is not one of our standards or otherwise
already approved. Review each section to determine whether the clause you are
analyzing conforms with our requirements. If you note a discrepancy, refer to
the hyperlinked clauses for help. If there are numerous problems with a clause,
try to substitute one of our standards rather than attempt extensive editing.
Please see our Publication
Checklist Interactive Form for assistance in the analysis of publication clauses
offered by Sponsors.
Please see our Confidentiality
Checklist Interactive Form for assistance in the analysis of confidentiality
clauses offered by Sponsors.
Please see our Intellectual
Property Checklist Interactive Form for assistance in the analysis of intellectual
property clauses offered by Sponsors.
Please see our Indemnification
Checklist Interactive Form for assistance in the analysis of indemnification
clauses offered by Sponsors.
As with all Agreements, Check
the Parties
- Principal Investigator is not
a party - signs as Read and Understood.
- Obligations throughout are Institution's,
not Principal Investigator's (for the most part - a few exceptions are okay).
- CRO contracts do not usually have
Sponsor as a party.
Indemnification
- Separate Sponsor-signed indemnification
letter (when Sponsor is not a party) or
- Contract Research Organization
("CRO") signs agreement containing Indemnification; you must have a separate
Sponsor-signed letter of agency in file (indicating that the CRO has the authority
to bind the Sponsor).
Universal with the Sponsor
- If yes, use intellectual property,
indemnification, confidentiality and publishing provisions from the Universal.
Please see our Dabatase
License Checklist Interactive Form for assistance in the analysis of database
license terms and conditions.
[Generally, it is best if
the results of the Study are not included in what is defined or referred to
as confidential information. If Sponsor-offered clauses contain language that
produces such a result, edit such clauses to delete references to the results
of the Study. If Sponsor insists that the results of the Study be considered
confidential information or that Sponsor will own the study data, you should
insert a cross-reference to our right to publish: "Subject to Institution's
right to publish the results of the Study as set forth in Section ___, . . ."]
If Sponsor Considers
Data or Results To Be Confidential Information
Institution shall not disclose or
use for any purpose other than performance of the Study any and all trade secrets,
privileged records or other confidential or proprietary information disclosed
to or, subject to the right of Institution to publish the
results of the Study, as set forth in Section ___ above, developed by the
Institution pursuant to this Agreement ("Confidential Information") ...
If Sponsor Wants
to Own Data
Written summaries of all data from the
Study will be transmitted to Sponsor as generated and promptly at the completion
of the program in a final written report. Sponsor owns these data, subject
to the right of Institution to publish the results of the study, as set forth
in Section ___ above, and may use the information generated hereunder for its
business goals; for example, in support of the prosecution of Sponsor patent applications
and in support and any IND and NDA.
