Background to CDA and MTA Transactions
Background to CDA Transactions
In more than 95% of cases, a CDA transaction occurs after a sponsor of an industry-sponsored clinical trial shares a study protocol and investigator brochure with a prospective principal investigator at the KUMC site in order for the prospective principal investigator and the KUMC team to (i) evaluate the study opportunity, (ii) negotiate a clinical trial agreement, and (iii) complete all of the protocol activation activities preliminary to a study activation. The sponsor requests the prospective site investigator and KUMC site to (i) not disclose the information supplied by the sponsor, and (ii) not use the information for any purpose other than evaluating whether to take part in the clinical trial.
There are other research-related situations that may involve a CDA. For example, a KUMC investigator may wish to discuss a new project with another university under terms of confidentiality. A prospective vendor for KUMC, such as a supplier of research tools, may ask KUMC to agree not to disclose the subject of conversations between KUMC and the prospective vendor.
Key terms in CDAs:
- How long must KUMC refrain from disclosing or using the information supplied by the sponsor?
We prefer a three-year limit but may accept longer intervals depending on the circumstances.
- May sponsor sue KUMC for injunctions in other states or without posting bonds?
We prefer to identify Kansas Law and Kansas venue for lawsuits and do not agree to waive the posting of a bond.
Background to MTA transactions
Research tools and materials are often loaned, transferred and licensed by a provider institution to be used exclusively for non-commercial purposes by one recipient investigator at a recipient institution using a "Material Transfer Agreement" or "MTA."
MTAs make materials available to a recipient. However, the MTA terms limit further transfer of the materials and may limit their use by the recipient to a predefined project or purpose. In other words, KUMC recipients of MTA-related materials should not normally expect to be able to (i) use received materials in new projects, (ii) transfer the materials to other KUMC investigators, or (iii) transfer the materials to investigators at other institutions. There are exceptions, but the nature of MTAs tends to limit the recipient's use to the lab of the one recipient scientist at the recipient institution. There are normally no rights reserved for retasking or redistributing the materials in any way.
Given that MTA-related materials are virtually locked by contract into the lab where they were originally requested, redistributing the materials requires a separate set of permissions and agreements, often best performed by the new proposed recipient returning to the original provider institution and obtaining a new MTA for the use of the materials in the new recipient investigator's lab at the new recipient institution.
Some research materials are available from commercial or noncommercial repositories. The repositories contain materials such as mice and plasmids. Originating institutions deposit the materials at the repositories, often so that the originating scientist/investigator is relieved of the burden of supplying the materials to requesting parties. The repositories make the materials available to requesting recipient investigators but attach terms contained in a Material Transfer Agreement or similar license agreement or letter agreements. When the repositories process the recipient's order for mice or plasmids, they usually request the recipient institution to agree to one or more separate sets of terms. One set of terms operates between the repository and the recipient. Often a second set of terms operates between the depositor and the recipient. For example, a depositor institution investigator creates a mouse strain, and then deposits the mouse strain at a commercial repository. During processing of the repository order for mice or plasmids, the institution completes one or more agreements with the repository and the depositor(s). Those agreements limit the use of the mice or plasmids to a particular investigator's lab at the recipient institution. Even in the case where a repository or depositor permits some redistribution of the materials by the recipient institution and investigator, the repository may require a "relocation letter" approved by the repository that confirms that the new recipient of the redistributed materials has been identified and has agreed to observe the terms of the MTA.