MTAs, CDAs and Consulting

Below is a resource to assist you with negotiating consulting agreements.

Industry/academic collaboration is important and ubiquitous. Be aware that legal documents you receive from industry may be seriously flawed, and if you sign them will directly harm you, your research, and your academic career. These agreements may create personal liabilities in unexpected ways. Contrary to what you may hear, these documents are negotiable. Please contact the Office of General Counsel at 617-355-2146 for more information.

The transfer of materials to different academic research and industry laboratories is a vital component of research in the life sciences. A Material Transfer Agreement (MTA) is a contract that presides over the exchange of tangible research materials between academic, government and commercial organizations.

Why are MTAs essential?

MTAs are essential because they address the rights and obligations of the receiving and sending parties, which include the investigator's right to publish. MTA's also cover the distribution of intellectual property and the issues surrounding confidentiality and liability that may result from the research, all of which must be agreed upon prior to the transfer of the material. Also, MTAs protect the provider's (company or another institution) rights to the materials. Agreement of the parties in advance of the material transfer avoids future misunderstandings or disputes that may arise regardless of how friendly the present relationship between provider and recipient might be.

Who negotiates the MTAs?

Boston Children's Hospital’s Clinical Trials Office (CTO) is responsible for the negotiation and review of MTAs to ensure conformity with Children's policies and proper handling of intellectual property rights. Children's researchers who plan to exchange materials with outside entities should contact the CTO for assistance in preparing and executing the documents: Every MTA must be signed by an authorized signatory for Children's.

What is the procedure?

For Sending Material: To send materials outside of Boston Children's Hospital, email the CTO at TIDO with the following information: name of the person to whom the material will be sent, their institution and the name of material. We will forward the appropriate documents to the receiving party and notify you when signatures have been obtained, thus allowing you to send the materials.

For Receiving Material: When looking to acquire material from outside of Boston Children's Hospital, forward all documents received from the provider to the CTO at TIDO@childrens.harvard.edu. We will review the documents to protect your academic and intellectual property rights, as well as to comply with Boston Children's Hospital policies. We will keep you informed throughout the negotiation process. Upon the resolution of any outstanding issues, we will notify you and return a fully executed copy of the MTA for your records

Before discussing your discoveries, inventions, data, hypotheses or research and clinical ideas with industry, it is important to have a confidential disclosure agreement (CDA) or non-disclosure agreement (NDA) in place. The CDA is entered into between Boston Children's Hospital and another party to enable the disclosure of trade secrets or confidential information from Boston Children's Hospital to the party without losing IP rights. There are two types of CDAs:

• In the one-way CDA, the party receiving the confidential information contractually agrees to keep that information confidential and use it only for the intended purpose. However, the receiving party must be careful to disclose only non-confidential information to the disclosing party, as that information is not obligated to be maintained as confidential.
• In the mutual or bi-lateral CDA, both parties may be a disclosing party and a receiving party of confidential information. Both parties agree to keep the other party's information confidential and to use the information only for the intended purpose.

Confidentiality Agreement Form (.doc)

TIDO is available to answer questions and to put a CDA in place by calling ext. 43019 or emailing tido@childrens.harvard.edu

Before discussing a potential clinical trial protocol with industry, it is important to have a confidential disclosure agreement (CDA) or non-disclosure agreement (NDA) in place. The CDA is entered into between Boston Children's Hospital and the other party to enable the disclosure of confidential information regarding the possible clinical trial. It is important to keep the discussions specific to the probable clinical trial project. There are two types of CDAs:

• In the one-way CDA, the party receiving the confidential information contractually agrees to keep that information confidential and use it only for the intended purpose. However, the receiving party must be careful to disclose only non-confidential information to the disclosing party, as that information is not obligated to be maintained as confidential.
• In the mutual or bi-lateral CDA, both parties may be a disclosing party and a receiving party of confidential information. Both parties agree to keep the other party's information confidential and to use the information only for the intended purpose

TIDO is available to answer questions and to put a CDA in place by calling ext. 43019 or emailing tido@childrens.harvard.edu