Confidentiality Clause Checklist for Sponsored Research Agreements and Clinical Trial Agreements

Body

Use this Checklist to analyze a Sponsor-offered confidentiality 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.

The sample clauses for this Checklist are available here: Confidentiality Sample Clauses or Publication Sample Clauses.


1. Does Sponsor’s clause contain some, but not all, of the following six exclusions?

  • The information is not disclosed in writing, or reduced to writing, and so marked with an appropriate confidentiality legend within thirty (30) days of disclosure;
  • The information is already in the recipient party’s possession at the time of disclosure thereof;
  • The information is, or later becomes, part of the public domain through no fault of the recipient party;
  • The information is received from a third party having no obligations of confidentiality to the disclosing party;
  • The information was independently developed by the recipient party; or
  • The information is required, by law or regulation, to be disclosed.

Typically, a Sponsor-offered clause will only contain 2 or 3 exclusions, such as the exclusion regarding materials already in the public domain or materials received from a third party who has the right to disclose them.

yes.

Add the exclusions that are missing. See Confidentiality Sample Clause 1.1, paragraphs a-f.

no.

If your clause contains no exclusions at all and is similar to our short-form, or contains all the exclusions, you may leave it as it is.


2. Does Sponsor’s clause contain a time limit on UT’s obligation to maintain confidentiality?

yes.

Be sure the time period is reasonable. Periods of 1-5 years are standard, though 7 years has been accepted on rare occasions with specific concurrence from the principal investigator. Periods of greater duration must be justified by some special reason that you document in your files. For example, a license agreement involving the Study material to which the Sponsor is party that requires a longer confidentiality provision.

no.

You must put a time limit on our obligations. See  Clause 1.1 (long form) and  Clause 2.1 (short form).


3. Does Sponsor’s clause make the results confidential?

yes.

Either delete the reference to results in the confidentiality clause, or cross-reference our right to publish the results. See Publication Sample Clause 3.

no.

Good. Leave the clause as it is.


4. Does the clause require that UT obtain written agreement regarding confidentiality from UT’s investigators and/or others who may work on the study?

yes.

Delete any such requirement.

no.

Good. Leave the clause as it is.