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Publication Clause Checklist for Sponsored Research Agreements and Clinical Trial Agreements

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Use this Checklist to analyze a Sponsor-offered publication clause; determine what problems, if any, the clause contains; and, determine the editorial changes necessary to conform the clause to the requirements of the Regents’ Rules and Regulations related to Intellectual Property. Because no two deals are identical, the best language for one transaction may not be the same as that for another transaction. If in doubt, please contact the Office of General Counsel with any questions.

Tips:

  • Preserve the absolute right of the Institution (PI) to publish the results of the study.
  • There are Unrelated Business Income Tax (UBIT) implications if we are just performing laboratory work for commercial entities; like a service provider.
  • Keep delays for review to a reasonable limit.
  • If the study is multi-site, try to preserve the right of the Institution (PI) to publish separately if, after a reasonable time, multi-site publications have not been forthcoming.
  • Make sure that the right to publish is properly cross-referenced in confidentiality provisions and in any provisions establishing ownership of data.
  • Remember that the owner of the copyright in publications pursuant to UT System Policy will be the PI, so Institution cannot give away licenses or other rights in the PI's publications.

The sample clauses for this Checklist can be found here: Publication Sample Clauses.


1. Does Sponsor's clause give Sponsor the right to approve University publications?

Look for words like "prior written consent," "approval," or language that denies the right to make the results public.

yes.

Substitute the word “review” for words like “approve” or “consent.” See Clauses 2.1, 3, 4, and 5.1.

no.

Good. Leave it as it is.

 


2. Is there a period of time for review and comment and/or removal of confidential information?

yes.

Be sure the time periods are reasonable; e.g., 10-60 days. Longer periods are okay on a case-by-case basis. Always review, with your Investigator, time periods beyond the usual, and be sure your Investigator understands any time periods prior to initiating work. See Clause 4.

no.

Okay as it is.

 


3. Is there a provision that gives Sponsor a right to further delay publication to protect intellectual property?

This further delay right may be stated as a right to secure patent protection or it may be more general, such as a right to protect inventions or intellectual property.

yes.

Be sure there is a reasonable time limit; e.g., 30-90 days. Longer time periods may be acceptable under some circumstances. Always review, with your Investigator, time periods beyond the usual and be sure your Investigator understands any time periods prior to initiating work. See Clauses 2.1, 3, 4, and 5.1.

no.

Okay as it is.

 


4. Is there a provision that gives Sponsor a right to publish a joint publication before the University may publish its findings?

This kind of clause often appears in connection with multi-site clinical studies, though it occasionally appears in other contexts.

yes.

We MUST have a time limit on the Sponsor’s right to publish the multi-site results first; e.g., 18-24 months is generally acceptable, from the finish of our part of the study (preferred) or from the end of the entire study. See Clause 5.1 (multi-site).

no.

Good. Leave out any reference to multi-site study, even if it is one.

 


5. Is there a provision somewhere else in the agreement that says the data will be owned by Sponsor?

Example: "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 and may use the information generated hereunder for its business goals."

yes.

Cross-reference our right to publish. See Clauses 2.1, 3, 4, and 5.1.

no.

Good. Leave it as is.

 


6. Is there a provision in the confidentiality clause making the results confidential?

Example: "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 developed by Institution pursuant to this Agreement ("Confidential Information")...."

yes.

Cross-reference our right to publish. See Clause 3.

no.

Good. Leave the clause as it is.