| CLICK HERE to go to MTA Templates. If you have any questions, please contact:
Julia Brill, Esq.
Copyright & Materials Transfer Officer
Phone: 410-516-4971 Fax: 410-516-6499 Email: jbrill7@jhmi.edu
Guidelines for Material Transfer Agreement Review
The Johns Hopkins Technology Transfer office (JHTT) reviews Material Transfer Agreements (MTAs), with the exception of those MTAs that include research funding or that place extensive reporting obligations on JHU to the provider of the materials. JHTT is also the office designated to review Confidentiality/Non-disclosure Agreements associated with the disclosure of information relating to JHU inventions. JHTT will obtain the authorized signature on behalf of JHU for these Agreements which are acceptable under JHUs policies and consistent with its academic mission. Please note: The Office of Research Administration is the office designated to review and process those MTAs which involve funding of the research by the providor of the material or that place extensive reporting obligations on JHU from the reseach using the material even where the providor is not funding the research . JHTT strives to review MTAs in a timely fashion to minimize any potential delays in research involving the requested materials or information. MTAs are reviewed by JHTT and signed by the authorized University official and the faculty investigator to protect certain interests of JHU and its faculty. It is important that faculty investigators also review MTAs to make sure that they personally agree to comply with the terms and that the terms of the MTA are consistent with the objectives of their research.
The single most significant delay in finalizing these agreements is due to the negotiation of the terms. While the majority of MTAs and NDAs require little negotiation, the ones that do happen to be those cases where material or information is being transferred from entities outside the university to JHU's faculty. This stems from the very different philosophies that university and companies maintain.
The following guidelines are used by JHTT to review agreements and are provided so JHU's faculty and companies can understand JHU's position on certain terms typically included in MTAs and/or NDAs.
Publication
Providers may ask for certain restrictions on publication resulting from Recipient’s use of the materials. In such cases, the Provider is interested in protecting confidential information related to the materials and new information generated through Recipient’s use of the materials. On the other hand, the Recipient needs to preserve their ability to publish their research findings.
Terms at issue:
A. Bars on publication or publication only with Provider’s prior approval
Some MTAs include terms that explicitly bar any publication of data obtained through the use of the materials. Alternatively, the MTA may state that any publication of data obtained through the use of the Material will be subject to the approval of the Provider. As an academic institution, JHU can not accept MTAs that place a bar, or have the potential to place a bar, on publications.
B. Provider’s prior review of publications
Although JHU can not agree to a bar on publications, it is customary for MTAs to require the Recipient to provide manuscripts to the Provider for review and comment prior to submission to a journal. The Recipient is typically required to submit publications to the Provider thirty (30) to sixty (60) days prior to submission to a journal (the "Pre-submission Period"). JHU can accept such terms in an MTA. Faculty should review their MTAs to ensure that they agree with the term of the Pre-submission Period. JHU will not agree to periods greater than sixty (60) days without the prior approval of its requesting faculty member.
C. Delays in publication
In addition to the Pre-submission Period, Providers’ MTAs may contain terms requiring a further delay in the submission of publications to a journal upon the request of the Provider ("Delay Period"). Delay Periods range from thirty (30) days to sixty (60) days. While these Delay Periods are acceptable to JHU, the combined Pre-submission Period and Delay Period can not exceed one hundred twenty (120) days under JHU’s policy. Faculty should review their MTAs to ensure that they agree with the term of the Delay Period.
D. Modifications to publications suggested by Provider
Some MTAs require the Recipient to include modifications to manuscripts suggested by the Provider. JHU considers such terms to restrict JHU’s academic freedom regarding publications and can not agree to such terms. On the other hand, JHU will agree to consider any comments provided by the Provider and JHU will agree to remove any of the Provider’s proprietary information contained in the manuscript that JHU is under an obligation to keep as confidential.
E. Co-Authorship with Provider’s investigators
MTAs may include terms that require the Recipient investigator to include the Providing scientist as a co-author on any publications resulting from the use of the Material. While JHU feels that it is inappropriate for such terms to be included in an MTA unless there is a true collaboration between the Provider and Recipient investigators, JHU will agree to such terms provided that it is acceptable to the Recipient investigator.
Considerations and
Confidential Information
Confidential and proprietary information may be provided along with the requested Material. MTAs often contain terms requiring the Recipient to maintain such information as confidential. It is important for faculty investigators to review confidentiality terms in MTAs to ensure that any information, such as sequence information or the molecular structure of a compound, which is required to be kept confidential under the MTA will not be required for the publication of research results.
Terms at issue:
A. Defining confidential information
Because of JHU’s concerns regarding its ability to publish the results of its research and because of a customary requirement to keep certain proprietary information as confidential, it is necessary for MTAs to carefully define that information which is required to be kept as confidential by JHU (the "Confidential Information"). As stated above, JHU can not agree to keep as confidential any information (e.g., data) generated through the use of the Material. For this reason, it is necessary for JHU to require that Confidential Information be defined as information received from the Provider which is indicated as confidential. It is important for Confidential Information to be indicated as such to eliminate any ambiguities regarding that which is Confidential Information and that which is not such as data generated by the Recipient.
B. Term of confidentiality obligation
It is customary for MTAs with confidentiality provisions to require that the Confidential Information be kept as confidential for a period of five (5) years. Some Providers may request longer periods of confidentiality. JHU can accept longer periods of confidentiality provided that such periods are acceptable to the faculty investigator; however, JHU can not accept confidentiality periods longer than ten (10) years. The period of confidentiality is limited due to the practicality of managing the confidential information. After a number of years, it is unlikely that the Recipient investigator will remember which information is under an obligation of confidentiality.
Intellectual Property
The most frequent negotiations in MTAs are related to intellectual property/inventions resulting from the use of the materials by the Recipient. Since the Provider is often supplying the materials at no cost to the Recipient, it is customary for the Provider to request some access to intellectual property/inventions developed by Recipient through the use of the materials.
Terms at issue:
A. Ownership of inventions
Provider MTAs at times will require any inventions made through the use of the materials ("Inventions") be owned by, or assigned to, the Provider. It is onerous and inappropriate for the Provider to obtain ownership of inventions made through the use of their materials. Furthermore, it is contrary to JHU’s policy and the laws associated with federally funded research. JHU will replace any such terms regarding ownership or assignment with language that grants the Provider the opportunity to take a license to any such Inventions.
B. Options
The grant of an opportunity to take a license is customary when the Provider is a for-profit entity and it is called an "Option". Options may include the right to take an exclusive or non-exclusive license on terms that will be negotiated between the parties. JHU accepts option terms in MTAs; however, the option must be a "first" option in which JHU gives the Provider the opportunity to reach agreement on the terms of a license prior to offering third parties a similar opportunity, or the option may be an "exclusive" option for a fixed period of time during which JHU can not offer a license to a third party (the "Option Period"). The Option Period is typically three (3) months from the time JHU notifies Provider of the making of an Invention. JHU will not agree to Option Periods longer than six (6) months.
C. Pre-negotiated Royalty Rates
MTAs may contain terms along with the grant of an option stating the terms under which a license will be negotiated. JHU can not agree to pre-negotiated royalties in an MTA for a number of reasons. First, it is difficult to anticipate an appropriate royalty rate for an invention that has not yet been made. Second, certain laws prohibit JHU as a non-profit institution from performing research in which Inventions are encumbered under terms with a pre-negotiated royalty.
D. Grants of licenses and options
JHU can agree to the actual grant of an option to the Provider in an MTA. On the other hand, some Provider MTAs contain an actual grant of a license to Inventions in the MTA. JHU can not accept such language in an MTA because a typical license agreement contains certain necessary terms that are not typically included in an MTA. Moreover, it is inappropriate for JHU to license Inventions to the Provider when such Inventions do not exist. JHU will change any "hereby grants [a license]" language in an MTA to "agrees to grant [a license]". While this change may seem trivial, it is an important and necessary change.
E. Non-exclusive royalty-free licenses
A number of MTAs from for-profit Providers contain a requirement that the Recipient agree to grant the Provider a non-exclusive, royalty-free license [for commercial purposes] to any Inventions. While JHU can agree to this language under certain circumstances, it is important for Recipient investigators to understand that agreeing to such language will make it unlikely that the Recipient investigator and JHU will receive any royalties or other revenues from the commercialization of any Inventions resulting from research utilizing the materials. While the non-exclusive, royalty-free license for commercial purposes is onerous, it is appropriate for JHU to agree to grant such a license for internal research purposes.
F. Exclusive royalty-free licenses
A few MTAs will contain language requiring the Recipient to grant to the Provider an exclusive, royalty-free license. This language basically gives the Provider the right to commercialize Inventions without making any payments to the Recipient. Furthermore, such language prevents JHU from licensing Inventions to third parties. This language is unacceptable to JHU.
G. Right of first refusal
Providers’ MTAs that contain the grant of an option may also contain language that grants to the Provider a right of first refusal. In the event that JHU and the Provider are unable to reach agreement on the terms of a license for an Invention that falls under an option and JHU subsequently negotiates a license with a third party, this language requires that JHU, prior to entering into a license agreement with the third party, offer Provider a license on the terms negotiated with the third party. If the Provider rejects the terms of the license, then JHU is then free to license the Invention to the third party. The right of first refusal language makes it difficult to potentially negotiate with a third party. JHU prefers to limit the right of first refusal to those cases when the terms negotiated with the third party are more favorable than those originally offered to the Provider.
H. Definition of "Materials"
MTAs typically define "Materials" to be those materials that the Provider is providing. In addition to the original materials being provided, the defined term, "Materials", may include other items. Typical and acceptable additions include, portions, progeny, and derivatives of the original material. The definition of Materials is important because the MTA contains a number of terms directed to the Materials. Materials usually can not be provided to another party, be used for commercial purposes, and are owned by the Provider. On occasion, MTAs will broaden the definition of Materials to include modifications and improvements of the materials and similar terms which could be construed to be new Inventions. JHU can not agree to include in the definition of Materials any subject matter that has the potential to be an Invention.
I. Patent prosecution
Patent prosecution for Inventions is something that should be managed by the owner of the patent rights to ensure that the patent is prosecuted to the fullest extent. MTAs may contain terms which give the Provider the right to file and prosecute patent applications on Inventions. Since all such Inventions are owned by JHU, JHU can not accept this language. When the Provider is granted an option to Inventions and is reimbursing JHU for patent expenses, JHU will give the Provider the right to review and comment on applications. MTAs may also include language requiring JHU to file on any Inventions made through the use of the materials. JHU evaluates inventions made by its faculty and files patents on inventions that meet certain criteria. JHU will not agree to language in an MTA that requires JHU to file patent applications on Inventions unless the Provider agrees to pay all patent expenses.
J. Conflicts between terms MTAs and other MTAs or sponsored research
Since MTAs can encumber Inventions by the grant of an option to Inventions or by JHU agreeing to grant to the Provider a license, it is important for Recipient investigators to determine whether the encumbrances in an MTA conflict with the terms of other MTAs or sponsored research agreements which may also contain encumbrances. JHU can not agree to grant both the Provider of a Material and a sponsor of research an exclusive license to the same invention. Recipient investigators need to inform JHTT of any potential conflicts.
Miscellaneous Provisions
In addition to the broad categories of terms described above which are typically included in MTAs-in, there are a number of other issues related to MTAs-in and MTAs-out which must be reviewed and often require modification.
Terms at issue:
A. Parties to the agreement
JHU, and not its faculty investigator, is the party to all MTAs. Many MTAs are drafted with the faculty investigator as the party to the agreement. JHU will modify the agreement such that "JHU through its employee Dr. ______" is the Recipient party. Although JHU’s faculty investigator is not a party to the agreement and although the faculty investigator does not have the authority bind JHU to the agreement, JHU requires that the investigator co-sign the agreement to indicate that he or she has read the agreement and agrees to abide by its terms. The investigator's signature on the agreement is required before JHU’s authorized person will sign the agreement. Any questions regarding the terms of the agreement may be directed to JHTT.
B. Use of name
JHU is concerned with the use of its name in association with MTAs. For this reason, JHU may require the addition of certain language in MTAs that places a prohibition on the use if its name by the other party to an MTA without the prior written approval of an officer of JHU.
C. MTAs versus Licensing
When JHU is the Provider in an MTA-out and the Recipient is a for-profit company, the faculty investigator may want to consider receiving a fee for the materials being provided. It is customary to receive a fee for materials when the Recipient wants to use the materials for commercial purposes, including providing a service, use in manufacturing, or use in screening of compound libraries. When a fee is received in consideration for materials being provided, a license agreement instead of an MTA is the appropriate instrument by which the Material is transferred. Please contact JHTT or complete a Report of Invention should you be interested in licensing a material.
D. Human Materials
There are a number of issues to be considered when providing or receiving materials of human origin. JHTT should be informed of any such transfers so the appropriate consent and other related issues can be addressed.
E. MTAs and gifts
JHTT needs to be informed by its faculty investigators when any MTA being provided to JHTT for review is with a party who is also providing a research gift. Conversely, the Office of Research Administration needs to be notified when a gift is offered by a party with which JHU has already signed an MTA. It is inappropriate for a company to receive an option to inventions under an MTA in research which is funded by a gift from the same company. |
