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Guidelines, policies, forms and agreements relevant to Harvard faculty inventors and external entrepreneurs, investors, and industry professionals.

Guidelines, Policies and Forms

Material Transfer Agreements

This section contains information for Harvard investigators regarding material transfers and material transfer agreements.

What is a Material Transfer Agreement?

A Material Transfer Agreement (MTA) is a contract for governing the exchange of tangible research materials between academic, government, and commercial organizations. The types of materials typically transferred under MTAs include cell lines, cultures, plasmids, nucleotides, proteins, bacteria, transgenic animals, pharmaceuticals, chemicals, and other proprietary physical materials.

Who Should I Contact about MTAs?

HMS/HSDM	Anastasia Tolu phone: 617-432-1744 fax: 617-432-2788 hms_materialtransfer@harvard.edu
FAS/SEAS	Melissa Dacey phone: 617-495-7533 fax: 617-495-9568 materialtransfer@harvard.edu
HSPH	Kathaleen Mercier, Director, Sponsored Programs Administration phone: 617-432-6060 fax: 617-432-2840 MTAinfo@sphofs.harvard.edu

Why are MTAs important?

MTAs are important because they specify the rights, obligations, and restrictions of both the providing and receiving parties with respect to issues such as:

Ownership of materials and modifications or derivatives of the materials made by the recipient
Limits on the recipient’s use of the materials and related liability
Restrictions on the recipient’s ability to transfer the material, modifications, and derivatives to third parties
Rights to inventions resulting from the use of the materials
Rights to publish research obtained through the use of the materials
Reporting and confidentiality obligations

Memorandum of Understanding for Material Transfer Agreements

A number of universities, of which Harvard is one, have agreed to a policy for the exchange of materials between academic and other non-profit institutions. Click here to read the Memorandum of Understanding.

Material Transfer: Procedures

Materials Incoming to Harvard
Materials Outgoing from Harvard

Incoming Materials

Whenever a member of the Harvard faculty wishes to obtain materials from a third party (whether from a non-profit or for-profit institution), the receiving scientist should complete our MTA Submittal form and attach a copy of the MTA for our review, negotiation and signature. Note: For security reasons, access to this form requires a Harvard ID and PIN.

MTA Submittal Form - Incoming Materials

Outgoing Materials

Faculty sending materials to other academic scientists can usually use the Simple Letter Agreement recommended by NIH. This agreement requires a signature by the providing Harvard scientist and signature by the receiving scientist and an authorized official of the receiving institution. If the receiving scientist or his/her institution want to modify the agreement, they should be referred to OTD so that mutually agreeable modifications can be worked out.

A Notice about this Simple Letter Agreement MTA format was sent to NIH Principal Investigators to explain NIH's new Research Tools Policy in which this MTA format is recommended.

There are several situations where the Simple Letter Agreement MTA format is not appropriate:

If the materials are covered by the transgenic animal patents licensed to DuPont;
If the materials resulted from a project funded by, or utilizing materials provided by, industry;
If the materials have been licensed to a for-profit company.

In any of these cases, the faculty member should contact OTD so that an appropriate MTA can be prepared. For further information regarding MTAs and industry, refer to the For Industry page.

MTAs: Why so Difficult?

Not all Materials Transfer Agreements (MTAs) are difficult to negotiate. In fact, exchange of biological (or any other types of) materials between academic (or other not-for-profit) institutions is relatively straightforward, especially if using the UBMTA (Uniform Biological Material Transfer Agreement) formats that were developed by AUTM (Association of University Technology Managers) and approved by the NIH (National Institutes of Health). There are two UBMTA formats: the UBMTA Implementing Letter and the Simple Letter Agreement. The former is used for transfer of materials which are the subject of a patent or patent application or which have been or are likely to be commercially licensed. The Simple Letter Agreement is used for all other transfers. OTD strongly encourages faculty members to use these formats when transferring materials to colleagues in academia. If you have any questions regarding which format to use, please contact us.

In contrast, transfer of materials to or from industry is usually managed on a case by case basis. OTD has a number of formats for transfer of materials from Harvard to a company, depending on the company's intended use. Please contact us if you are contemplating transfer of materials to a company, and we will determine the appropriate format.

For transfer of materials to Harvard from a company, we are usually required to use that company's internally developed formats. Each MTA must, therefore, be negotiated on a case-by-case basis, with particular issues being more important to one company than to another. The following, however, are a number of recurring issues:

Confidentiality: When confidential information is exchanged along with the material, the company requests that such information not be further disclosed. If the information is necessary for interpretation of the results obtained using the material, that same information may also be required for meaningful publication of those results. Having agreed to hold the information confidential could, therefore, prohibit an investigator from publishing his/her research. There are several ways to deal with this issue. We can: (a) request that no confidential information be provided, (b) request that only confidential information that is not required for publication be provided (i.e., background confidential information), or (c) request that any confidential information which is provided be disclosed if the investigator can demonstrate that such disclosure is necessary for meaningful publication.
Delay in Publication: In order to protect potentially patentable inventions, companies often demand a review period for manuscripts, abstracts or hard-copies of presentation materials. This demand may jeopardize the timeliness of publication. Harvard policies allow for a delay of no more than thirty days for review of manuscripts prior to submission, with the possibility of an additional thirty day delay (i.e., sixty days in total) for filing of patents.
Intellectual Property: Care must be taken to assure appropriate protection of Harvard’s rights in inventions (including modifications and derivatives of the materials) that are conceived and/or reduced to practice by the investigator in the performance of the research with the materials.
Replication: Many scientific journals require that materials be made available to other academic investigators for independent verification of research results. We therefore request that companies transferring materials to Harvard investigators agree to provide those same materials to other academic scientists who wish to repeat the published experiments. Although some companies argue that such provisions jeopardize the company's control over its own material, a middle ground can usually be found that accommodates each party's needs.

Material Transfer

Exchange of biological materials (such as clones, plasmids, hybridomas and DNA fragments) are often made between scientists at academic and commercial institutions. Material Transfer Agreements (MTAs) define the rights of the donating scientists, the recipient scientists, and their institutions with respect to the material and any derivatives thereof. MTAs also define the rights of both parties in the event of an invention made using the material. MTAs involving commercial entities must be authorized by OTD.

MTAs for incoming materials are negotiated by OTD. Companies planning to supply materials to Harvard scientists should contact OTD; OTD will coordinate negotiation and approval by Harvard University.

Companies planning to obtain materials from Harvard scientists should contact OTD to negotiate an appropriate MTA or license agreement.

Using the NIH Simple Letter Agreement

As part of an effort to improve access to research tools and materials, NIH has strongly recommended that scientists at non-profit institutions use a Simple Letter Agreement when exchanging materials. Please use this MTA when sending materials to colleagues at other non-profit institutions.

When requesting materials from governmental or other non-profit institutions, please ask your colleague to use the same format. It will speed the processing of the MTA here and thus permit you to obtain the requested materials sooner.

Unfortunately, this MTA format may not be appropriate if:

the materials are covered by the transgenic animal patents licensed to DuPont;
the materials resulted from a project funded by, or utilizing materials provided by, industry; or
the materials have been licensed to a for-profit company.

Other agreement formats that deal with most of these situations are available from the Office of Technology Development (OTD).

Individual MTAs with for-profit companies still require negotiation and, if the companies do not agree to follow the NIH Principles and Guidelines, these negotiations may still be complex and time-consuming. Some of the MTA terms that require negotiation are discussed in the booklet Material Transfer in Academia that may be found at the COGR website.

A copy of the complete Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources can be found at the NIH website.

If you have questions about the Principles and Guidelines please contact OTD.

Simple Letter Agreement (MTA)

Simple Letter Agreement for the Transfer of Materials

In response to the RECIPIENT's request for the MATERIAL [insert description] the PROVIDER asks that the RECIPIENT and the RECIPIENT SCIENTIST agree to the following before the RECIPIENT receives the MATERIAL:

The above MATERIAL is the property of the PROVIDER and is made available as a service to the research community.
THIS MATERIAL IS NOT FOR USE IN HUMAN SUBJECTS.
The MATERIAL will be used for teaching or not-for-profit research purposes only.
The MATERIAL will not be further distributed to others without the PROVIDER's written consent. The RECIPIENT shall refer any request for the MATERIAL to the PROVIDER. To the extent supplies are available, the PROVIDER or the PROVIDER SCIENTIST agree to make the MATERIAL available, under a separate Simple Letter Agreement to other scientists for teaching or not-for-profit research purposes only.
The RECIPIENT agrees to acknowledge the source of the MATERIAL in any publications reporting use of it.
Any MATERIAL delivered pursuant to this Agreement is understood to be experimental in nature and may have hazardous properties. THE PROVIDER MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESSED OR IMPLIED. THERE ARE NO EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR THAT THE USE OF THE MATERIAL WILL NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK, OR OTHER PROPRIETARY RIGHTS. Unless prohibited by law, Recipient assumes all liability for claims for damages against it by third parties which may arise from the use, storage or disposal of the Material except that, to the extent permitted by law, the Provider shall be liable to the Recipient when the damage is caused by the gross negligence or willful misconduct of the Provider.
The RECIPIENT agrees to use the MATERIAL in compliance with all applicable statutes and regulations.
The MATERIAL is provided at no cost, or with an optional transmittal fee solely to reimburse the PROVIDER for its preparation and distribution costs. If a fee is requested, the amount will be indicated here: [insert fee].

The PROVIDER, RECIPIENT and RECIPIENT SCIENTIST must sign both copies of this letter and return one signed copy to the PROVIDER. The PROVIDER will then send the MATERIAL.
PROVIDER INFORMATION
Provider Scientist:
Provider Organization:
Address:
RECIPIENT INFORMATION and AUTHORIZED SIGNATURE
Recipient Scientist:
Recipient Organization:
Address:
Name of Authorized Official:
Title of Authorized Official:
Signature of Authorized Official:
Date:
Certification of Recipient Scientist: I have read and understood the conditions outlined in this Agreement and I agree to abide by them in the receipt and use of the MATERIAL.
Recipient Scientist:
Date:

UBMTA

Uniform BioMaterial Transfer Agreement

I. Definitions:

PROVIDER: Organization providing the ORIGINAL MATERIAL. The name and address of this party will be specified in an implementing letter.
PROVIDER SCIENTIST: The name and address of this party will be specified in an implementing letter.
RECIPIENT: Organization receiving the ORIGINAL MATERIAL. The name and address of this party will be specified in an implementing letter.
RECIPIENT SCIENTIST: The name and address of this party will be specified in an implementing letter.
ORIGINAL MATERIAL: The description of the material being transferred will be specified in an implementing letter.
MATERIAL: ORIGINAL MATERIAL, PROGENY, and UNMODIFIED DERIVATIVES. The MATERIAL shall not include: (a) MODIFICATIONS, or (b) other substances created by the RECIPIENT through the use of the MATERIAL which are not MODIFICATIONS, PROGENY, or UNMODIFIED DERIVATIVES.
PROGENY: Unmodified descendant from the MATERIAL, such as virus from virus, cell from cell, or organism from organism.
UNMODIFIED DERIVATIVES: Substances created by the RECIPIENT which constitute an unmodified functional subunit or product expressed by the ORIGINAL MATERIAL. Some examples include: subclones of unmodified cell lines, purified or fractionated subsets of the ORIGINAL MATERIAL, proteins expressed by DNA/RNA supplied by the PROVIDER, or monoclonal antibodies secreted by a hybridoma cell line.
MODIFICATIONS: Substances created by the RECIPIENT which contain/incorporate the MATERIAL.
COMMERCIAL PURPOSES: The sale, lease, license, or other transfer of the MATERIAL or MODIFICATIONS to a for-profit organization. COMMERCIAL PURPOSES shall also include uses of the MATERIAL or MODIFICATIONS by any organization, including RECIPIENT, to perform contract research, to screen compound libraries, to produce or manufacture products for general sale, or to conduct research activities that result in any sale, lease, license, or transfer of the MATERIAL or MODIFICATIONS to a for-profit organization. However, industrially sponsored academic research shall not be considered a use of the MATERIAL or MODIFICATIONS for COMMERCIAL PURPOSES per se, unless any of the above conditions of this definition are met.
NONPROFIT ORGANIZATION(S): A university or other institution of higher education or an organization of the type described in section 501(c)(3) of the Internal Revenue Code of 1954 (26 U.S.C. 501(c)) and exempt from taxation under section 501(a) of the Internal Revenue Code (26 U.S.C. 501(a)) or any nonprofit scientific or educational organization qualified under a state nonprofit organization statute. As used herein, the term also includes government agencies.

II. Terms and Conditions of this Agreement:

The PROVIDER retains ownership of the MATERIAL, including any MATERIAL contained or incorporated in MODIFICATIONS.
The RECIPIENT retains ownership of: (a) MODIFICATIONS (except that, the PROVIDER retains ownership rights to the MATERIAL included therein), and (b) those substances created through the use of the MATERIAL or MODIFICATIONS, but which are not PROGENY, UNMODIFIED DERIVATIVES or MODIFICATIONS (i.e., do not contain the ORIGINAL MATERIAL, PROGENY, UNMODIFIED DERIVATIVES). If either 2 (a) or 2 (b) results from the collaborative efforts of the PROVIDER and the RECIPIENT, joint ownership may be negotiated.
The RECIPIENT and the RECIPIENT SCIENTIST agree that the MATERIAL:

is to be used solely for teaching and academic research purposes;
will not be used in human subjects, in clinical trials, or for diagnostic purposes involving human subjects without the written consent of the PROVIDER;
is to be used only at the RECIPIENT organization and only in the RECIPIENT SCIENTIST's laboratory under the direction of the RECIPIENT SCIENTIST or others working under his/her direct supervision; and
will not be transferred to anyone else within the RECIPIENT organization without the prior written consent of the PROVIDER.

The RECIPIENT and the RECIPIENT SCIENTIST agree to refer to the PROVIDER any request for the MATERIAL from anyone other than those persons working under the RECIPIENT SCIENTIST's direct supervision. To the extent supplies are available, the PROVIDER or the PROVIDER SCIENTIST agrees to make the MATERIAL available, under a separate implementing letter to this Agreement or other agreement having terms consistent with the terms of this Agreement, to other scientists (at least those at NONPROFIT ORGANIZATION(S)) who wish to replicate the RECIPIENT SCIENTIST's research; provided that such other scientists reimburse the PROVIDER for any costs relating to the preparation and distribution of the MATERIAL.

The RECIPIENT and/or the RECIPIENT SCIENTIST shall have the right, without restriction, to distribute substances created by the RECIPIENT through the use of the ORIGINAL MATERIAL only if those substances are not PROGENY, UNMODIFIED DERIVATIVES, or MODIFICATIONS.
Under a separate implementing letter to this Agreement (or an agreement at least as protective of the PROVIDER's rights), the RECIPIENT may distribute MODIFICATIONS to NONPROFIT ORGANIZATION(S) for research and teaching purposes only.
Without written consent from the PROVIDER, the RECIPIENT and/or the RECIPIENT SCIENTIST may NOT provide MODIFICATIONS for COMMERCIAL PURPOSES. It is recognized by the RECIPIENT that such COMMERCIAL PURPOSES may require a commercial license from the PROVIDER and the PROVIDER has no obligation to grant a commercial license to its ownership interest in the MATERIAL incorporated in the MODIFICATIONS. Nothing in this paragraph, however, shall prevent the RECIPIENT from granting commercial licenses under the RECIPIENT's intellectual property rights claiming such MODIFICATIONS, or methods of their manufacture or their use.

The RECIPIENT acknowledges that the MATERIAL is or may be the subject of a patent application. Except as provided in this Agreement, no express or implied licenses or other rights are provided to the RECIPIENT under any patents, patent applications, trade secrets or other proprietary rights of the PROVIDER, including any altered forms of the MATERIAL made by the PROVIDER. In particular, no express or implied licenses or other rights are provided to use the MATERIAL, MODIFICATIONS, or any related patents of the PROVIDER for COMMERCIAL PURPOSES.
If the RECIPIENT desires to use or license the MATERIAL or MODIFICATIONS for COMMERCIAL PURPOSES, the RECIPIENT agrees, in advance of such use, to negotiate in good faith with the PROVIDER to establish the terms of a commercial license. It is understood by the RECIPIENT that the PROVIDER shall have no obligation to grant such a license to the RECIPIENT, and may grant exclusive or non-exclusive commercial licenses to others, or sell or assign all or part of the rights in the MATERIAL to any third party(ies), subject to any pre-existing rights held by others and obligations to the Federal Government.
The RECIPIENT is free to file patent application(s) claiming inventions made by the RECIPIENT through the use of the MATERIAL but agrees to notify the PROVIDER upon filing a patent application claiming MODIFICATIONS or method(s) of manufacture or use(s) of the MATERIAL.
Any MATERIAL delivered pursuant to this Agreement is understood to be experimental in nature and may have hazardous properties. The PROVIDER MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESSED OR IMPLIED. THERE ARE NO EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR THAT THE USE OF THE MATERIAL WILL NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK, OR OTHER PROPRIETARY RIGHTS.
Except to the extent prohibited by law, the RECIPIENT assumes all liability for damages which may arise from its use, storage or disposal of the MATERIAL. The PROVIDER will not be liable to the RECIPIENT for any loss, claim or demand made by the RECIPIENT, or made against the RECIPIENT by any other party, due to or arising from the use of the MATERIAL by the RECIPIENT, except to the extent permitted by law when caused by the gross negligence or willful misconduct of the PROVIDER.
This agreement shall not be interpreted to prevent or delay publication of research findings resulting from the use of the MATERIAL or the MODIFICATIONS. The RECIPIENT SCIENTIST agrees to provide appropriate acknowledgment of the source of the MATERIAL in all publications.
The RECIPIENT agrees to use the MATERIAL in compliance with all applicable statutes and regulations, including Public Health Service and National Institutes of Health regulations and guidelines such as, for example, those relating to research involving the use of animals or recombinant DNA.
This Agreement will terminate on the earliest of the following dates: (a) when the MATERIAL becomes generally available from third parties, for example, though reagent catalogs or public depositories or (b) on completion of the RECIPIENT's current research with the MATERIAL, or (c) on thirty (30) days written notice by either party to the other, or (d) on the date specified in an implementing letter, provided that:

if termination should occur under 13(a), the RECIPIENT shall be bound to the PROVIDER by the least restrictive terms applicable to the MATERIAL obtained from the then-available resources; and
if termination should occur under 13(b) or (d) above, the RECIPIENT will discontinue its use of the MATERIAL and will, upon direction of the PROVIDER, return or destroy any remaining MATERIAL. The RECIPIENT, at its discretion, will also either destroy the MODIFICATIONS or remain bound by the terms of this agreement as the apply to MODIFICATIONS; and
in the event the PROVIDER terminates this Agreement under 13(c) other than for breach of this Agreement or for cause such as an imminent health risk or patent infringement, the PROVIDER will defer the effective date of termination for a period of up to one year, upon request from the RECIPIENT, to permit completion of research in progress. Upon the effective date of termination, or if requested, the deferred effective date of termination, RECIPIENT will discontinue its use of the MATERIAL and will, upon direction of the PROVIDER, return or destroy any remaining MATERIAL. The RECIPIENT, at its discretion, will also either destroy the MODIFICATIONS or remain bound by the terms of this agreement as they apply to MODIFICATIONS.

Paragraphs 6, 9 and 10 shall survive termination.
The MATERIAL is provided at no cost, or with an optional transmittal fee solely to reimburse the PROVIDER for its preparation and distribution costs. If a fee is requested by the PROVIDER, the amount will be indicated in an implementing letter.

UBMTA Implementing Letter

Uniform BioMaterial Transfer Agreement

UBMTA Implementing Letter

The purpose of this letter is to provide a record of the biological material transfer, to memorialize the agreement between the PROVIDER SCIENTIST (identified below) and the RECIPIENT SCIENTIST (identified below) to abide by all terms and conditions of the Uniform Biological Material Transfer Agreement ("UBMTA") March 8, 1995, and to certify that the RECIPIENT (identified below) organization has accepted and signed an unmodified copy of the UBMTA. The RECIPIENT organization's Authorized Official also will sign this letter if the RECIPIENT SCIENTIST is not authorized to certify on behalf of the RECIPIENT organization. The RECIPIENT SCIENTIST (and the Authorized Official of RECIPIENT, if necessary) should sign both copies of this letter and return one signed copy to the PROVIDER. The PROVIDER SCIENTIST will forward the material to the RECIPIENT SCIENTIST upon receipt of the signed copy from the RECIPIENT organization. This Implementing Letter is effective when signed by all parties. The parties executing this Implementing Letter certify that their respective organizations have accepted and signed an unmodified copy of the UBMTA, and further agree to be bound by its terms, for the transfer specified above. Please fill in all of the blank lines below:

Original Material (Enter Description): [description]
Optional Termination Date: [date]
Optional Transmittal Fee (to reimburse the PROVIDER for preparation and distribution costs): [Amount]
PROVIDER (Organization providing the ORIGINAL MATERIAL):

Name of Organization:
Street Address:
City/State/ZIP:

PROVIDER SCIENTIST:

Name and Title:
Street Address:
City/State/ZIP:
Signature:
Date:

RECIPIENT SCIENTIST:

Name and Title:
Street Address:
City/State/ZIP:
Signature:
Date:

RECIPIENT ORGANIZATION CERTIFICATION (Organization receiving the ORIGINAL MATERIAL):

Name and Title:
Street Address:
City/State/ZIP:
Signature:
Date: