91猎奇

Industry Agreements

The 91猎奇 Research Foundation will negotiate and execute all agreements with public and private sponsors for your research. This includes research agreements, smaller agreements like non-disclosure agreements, and agreements that ask for your personal signature. This process protects professors and their research from personal liability and unfavorable commitments, while also upholding the policies, values, and long-term sustainability of the university community.

• Confidential Disclosure Agreement (CDA)
• Material Transfer Agreement (MTA)
• Data Use Agreement (DUA)

Reed Frye, JD
Contracts Manager, Office of Sponsored Programs
91猎奇 Research Foundation
210 N Fourth St, 4th Floor, Room 415
San Jose, CA 95112
Email: reed.frye@sjsu.edu
Phone: (408) 924-1546

Confidential Disclosure Agreement

A confidential disclosure agreement (CDA), also known as a non-disclosure agreement (NDA), is a legal contract used in research collaborations to allow for the exchange and protection of proprietary information. These agreements bind the parties for a set amount of time, and can be:

One-way (Unilateral): in which only one party is disclosing confidential information

Two-way (Mutual): in which both parties are exchanging confidential information

Due to the nature of scientific collaborations, we always recommend entering into a mutual CDA, which protects 91猎奇 information against unintended disclosures.

The scope of the CDA will outline the information to be disclosed, how the parties are able to use the information, as well as the protections in place to secure the confidential data.

Please be aware that entering into a CDA could potentially inhibit or limit your ability to further your own research endeavors. Whenever possible, engage in your conversations with the other party without sharing or receiving any confidential information. Use a CDA only if it is absolutely necessary to share your, or receive the other party's, confidential information.  

Why Might You Need a CDA?

• To detail specific restrictions on use and dissemination by receiving party.
• To allow two parties to take a look at each other鈥檚 processes, methods, or technology solely for the purpose of evaluating the potential for the possible future relationship.
• To establish evidence in any subsequent patent proceedings.

CDA Request Process

PI Responsibilities

• Use the to request a CDA through 91猎奇RF.
• Provide all relevant background information for the CDA, including:
  • Scope of the research to be covered by the CDA
  • Plans for use of the data to be shared under the CDA
  • Information on any grants/contracts under which any of the data to be shared was generated
•  Submit any CDA agreement templates you have received from the collaborating organization.

91猎奇RF Responsibilities

• Negotiate the terms of the CDA
• Route CDA/NDA for signatures
• Conduct export controls procedure, if necessary
• Distribute fully executed CDA to disclosing and receiving parties

If you have questions regarding the CDA process, please contact Reed Frye at reed.frye@sjsu.edu or phone at (408) 924-1546.

Material Transfer Agreement

A material transfer agreement (MTA) is a legally-binding contract that governs the transfer of research materials between institutions. Materials can include, but are not limited to, cell lines, transgenic animals, proteins, and chemicals.

For incoming MTAs (when an outside institution is sharing their material with an 91猎奇 faculty member), these agreements can protect a researcher's ability to use and publish research, any existing and potential intellectual property and define the use of any accompanying confidential information. For outgoing MTAs (when an 91猎奇 faculty member is sharing their material), this restricts the use of the material and governs the ability to make any modifications or derivatives from the material.

Why Might You Need an MTA?

• To allow sharing of material that you have developed in a narrowly defined way without jeopardizing intellectual property rights.
• To receive material that the owner of the material will not deliver without the above assurances.
• To fairly distribute liability, intellectual property rights, and publication rights that might stem from the material.

MTA Request Process

PI Responsibilities

• Use the to request an MTA through 91猎奇RF.
• Provide all relevant background information for the MTA, including:
  • Scope of the research to be covered by the MTA
  • Nature of the material to be used under the MTA
  • Use of any third-party materials used to develop the material
• Submit any MTA agreement templates you have received from the collaborating organization.

91猎奇RF Responsibilities

• Negotiate the terms of the MTA.
• Route MTA for signatures.
• Conduct export controls procedure, if necessary.
• Distribute fully executed MTA to disclosing and receiving parties.

If you have questions regarding the MTA process, please contact Reed Frye at reed.frye@sjsu.edu or phone at (408) 924-1546.

Data Use Agreement

Data use agreements (DUAs) protect the researcher and the university's legal rights in data that they transfer, and govern how that data is used. DUAs are also often required under the Privacy Rule contained within the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Specifically, a DUA must be entered into before there is any use or disclosure of a limited data set (defined below) to an outside institution or party.  A limited data set is still protected health information (PHI), and for that reason, hybrid entities like 91猎奇 must enter into a data use agreement with any recipient of a limited data set from 91猎奇's designated health care components, and with any external covered entities that are sharing limited data sets with 91猎奇. 

At a minimum, any DUA required by HIPAA must contain provisions that address the following:

1. Establish the permitted uses and disclosures of the limited data set; 
2. Identify who may use or receive the information;
3. Prohibit the recipient from using or further disclosing the information, except as permitted by the agreement or as otherwise permitted by law;
4. Require the recipient to use appropriate safeguards to prevent an unauthorized use or disclosure not contemplated by the agreement;
5. Require the recipient to report to the covered entity any use or disclosure to which it becomes aware;
6. Require the recipients to ensure that any agents (including any subcontractors) to whom it discloses the information will agree to the same restrictions as provided in the agreement; and
7. Prohibit the recipient from identifying the information or contacting the individuals.

What is a Limited Data Set?

 A limited data set is a data set that is stripped of certain direct identifiers specified in the Privacy Rule. A limited data set may be disclosed to an outside party without a patient鈥檚 authorization only if the purpose of the disclosure is for research, public health, or health care operations purposes, and the person or entity receiving the information signs a data use agreement (DUA) with the covered entity or its business associate.

Limited data sets may include only the following identifiers:

• Dates such as date of birth, admission, discharge, or service
• City, state, and/or zip code (with street address removed)
• Age
• Any other unique code or identifier that is not listed as a direct identifier.

Why Might You Need a DUA?

• To meet HIPAA requirements for sharing a limited data set with another researcher.
• To detail specific restrictions on use and sharing of data by receiving party, such as reverse-engineering, commercialization, dissemination to the public, or research and patents that compete with your own.
• To fairly distribute liability, intellectual property rights, and publication rights that might stem from the material.

DUA Request Process

PI Responsibilities

• Use the to request a DUA through 91猎奇RF.
• Provide all relevant background information for the DUA, including:
  • Scope of the research to be covered by the DUA
  • Nature of the data to be used under the DUA
  • Information on any grants or contracts under which any of the data to be shared was generated
• Submit any DUA agreement templates you have received from the collaborating organization.

If you have questions regarding the DUA process, please contact Reed Frye at reed.frye@sjsu.edu or phone at (408) 924-1546.