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Policies and Forms

Material Transfer Agreement

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 A. Tolu phone: 617-432-1744    fax: 617-432-2788 hms_materialtransfer@harvard.edu
FAS/DEAS	Leah Tenney phone: 617-384-5264    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

Material Transfer: Procedures

• Materials Incoming to Harvard
• Materials Outgoing from Harvard
• Cre-Lox Materials

Incoming Materials

Whenever an MTA is received for materials to be provided to Harvard faculty by a third party (whether another non-profit or a for-profit institution), the receiving scientist should forward the MTA to OTD through the following link for review, negotiation and signature.

• MTA Submittal Form

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:

1. If the materials contain cre or lox DNA;
2. If the materials are covered by the transgenic animal patents licensed to DuPont;
3. If the materials resulted from a project funded by, or utilizing materials provided by, industry;
4. 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. For more information about distributing cre-lox materials, refer to the Crelox 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.

Cre-Lox Materials

In 1998, the NIH and DuPont Pharmaceuticals entered into a Memorandum of Understanding (MOU) which permits NIH/PHS scientists to use Cre-Lox technology in most research provided that research that is not "for the direct benefit of any for-profit institution." (A copy of the MOU is available from the NIH website.) Most important for Harvard, this MOU committed DuPont to enter into similar agreements with NIH-funded non-profit institutions.

Harvard subsequently signed a license with DuPont which gives University scientists the right to use the Cre-Lox technology for many types of research that are conducted at the University. However, there are certain restrictions - fields of research that are not covered and limitations on the further distribution of materials which contain cre DNA and/or lox DNA. In 2001, Bristol-Myers Squibb Company (BMS) acquired DuPont Pharmaceuticals Company (DuPont) and thus Harvard's Cre-Lox license is now with Bristol-Myers Squibb.

Because the license agreement places obligations on Harvard and all its scientists, your cooperation is needed. Please follow the instructions below before you request any Cre-Lox materials or send any such materials to third parties.

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.

Additional information is available on the Material Transfer page

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 contain cre or lox DNA;
• 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:

Material Transfer Agreement Between Harvard University and Third Party Academic Institutions for Cre-Lox Materials

The text of this Agreement has been modified to reflect the acquisition of DuPont Pharmaceuticals Company by Bristol-Myers Squibb Company

The President and Fellows of Harvard College ('Institution') is willing to provide Material (defined below) to [scientist] ('Investigator') of [institution] ('Recipient Institution') (hereinafter collectively 'Recipient') solely for the internal academic research purposes as described below, under the following terms.

• Upon execution of this agreement, Institution shall provide to Investigator samples of the Material. "Material" as used herein means [description], and any cell line or progeny containing lox DNA or cre DNA derived directly or indirectly therefrom.
• The Material is covered by the claims of U.S. patent number 4,959,317, which has been assigned by DuPont Pharmaceuticals Company to Bristol-Myers Squibb Company (BMS).
• If Recipient Institution has a license from DuPont (BMS), Recipient may use the Material subject to the terms of that license. Alternatively, Recipient shall be subject to paragraphs 4, 5, 6, 7 below.
• Recipient may use the Material solely for its internal non-commercial biomedical research purposes, provided however, that such research purposes specifically excludes (i) use of cre DNA and/or lox DNA in higher plants or agricultural applications, (ii) use of cre DNA and/or lox DNA in the alteration of mouse embryonic stem cells or other pluripotential mouse cells for the purpose of preparing a library of such mouse embryonic stem cells or other pluripotential mouse cells containing cre and/or lox DNA, and (iii) use of any material containing cre DNA and/or lox DNA which is encompassed by U.S. patent number 4,959,317 for any commercial purpose or for the benefit of any for-profit institution. Recipient shall not use the Material in the development, manufacture, use, lease, sale (or other transfer for consideration) or importation of any product for sale (or lease or other transfer of a product for consideration) wherein the manufacture use, sale or importation of such product would infringe U.S. patent number 4,959,317, including but not limited to wherein the product is manufactured using a composition or method which would infringe U.S. patent number 4,959,317. Recipient shall not use the Material to generate scientific data or information that is conveyed to a third party for consideration, except as may be permitted under a written agreement between the Recipient Institution and BMS.
• The Material, and any progeny or derivatives containing cre DNA and/or lox DNA derived directly or indirectly therefrom, may not be transferred by the Recipient to any third parties, except as may be permitted under a written agreement between the Recipient Institution and BMS.
• With respect to any questions regarding license rights under U.S. patent number 4,959,317, Recipient should contact:

Director, External Science and Technology Group
Bristol-Myers Squibb Company
Experimental Station - E353/224
Wilmington, Delaware 19880
With a copy of all notices to:
Vice President and Senior Counsel, Pharmaceutical Research
Institute and Business Development
P.O. Box 4000
Princeton, New Jersey 08543-4000

• Recipient agrees that any person utilizing the Material within Recipient Institution will be advised of and shall be subject to the conditions of this Agreement.

The parties agree to the foregoing and have caused this Agreement to be executed by their duly authorized representatives.
[Signature for Harvard]
[Signature for Recipient Institution]
[Signature of/for Recipient Investigator]

What to do if you want to use the Cre-lox technology

For Harvard Medical School and Harvard School of Dental Medicine:
Contact: Office of Technology Development – Gordon Hall 414
617-432-0920.
For the rest of the University:
Contact: Office of Technology Development – Holyoke Center 727
617-495-3067.

• Provide the following information:
• A brief description of the research to be conducted;
• Funding sources to be used to support that research;
• The source of any third-party materials to be used in that research.
• Sign below to confirm that you understand and will abide by the terms of the BMS license agreement including the following limitations:
• investigators cannot use cre DNA and/or lox DNA in higher plants or agricultural applications;
• investigators cannot use cre DNA and/or lox DNA in the alteration of mouse embryonic stem cells or other pluripotential mouse cells for the purpose of preparing a library of such mouse embryonic stem cells or other pluripotential mouse cells containing cre DNA and/or lox DNA;
• investigators cannot use any material containing cre DNA and/or lox DNA for 'any commercial purpose' or for the 'benefit of any for-profit institution' - thus the Cre-lox technology cannot generally be used in any research sponsored by a for-profit source or in research using biological materials received from a for-profit source;
• investigators cannot provide any material containing cre DNA and/or lox DNA to others (whether to a non-profit or to a for-profit institution) except under specific conditions and under a special Material Transfer Agreement.
• If you want to use the technology for 2a, 2b, or 2c above, ask OTD or to attempt to obtain additional rights from BMS.
• If you want to send cre or lox materials to a non-profit, contact OTD to confirm that the recipient institution has a BMS license and to obtain the MTA that must be used for the transfer. This agreement must be signed on behalf of Harvard by the OTD and must be signed by both the recipient scientist and an authorized official of his/her institution. The fully signed agreement must be on file with OTD before the materials are transferred.
• If you want to send cre or lox materials to a for-profit organization, contact OTD since a special agreement will need to be negotiated and the for-profit must have a license from BMS and must pay BMS a fee.
• Upon BMS's request, you will have to provide BMS with 'reasonable quantities' of any materials made using the Cre-lox technology. BMS will only be permitted to use these materials for research purposes.

UNDERSTOOD AND AGREED:
[Signature] [Date]
Attach the information requested in item 1 and return a signed copy of this document to:
Office of Technology Development
Harvard Medical School
25 Shattuck Street
Gordon Hall of Medicine, Room 414
Boston, MA 02115
or to
Office of Technology Development
Holyoke Center, Suite 727
1350 Massachusetts Ave.
Cambridge, MA 02138

Non-Commercial Research License Agreement

THIS AGREEMENT, effective on the 15th day of July, 1999 (the "Effective Date"), is entered into by and between DUPONT PHARMACEUTICALS COMPANY, a general partnership of the State of Delaware with its principal place of business at Chestnut Run Plaza, Walnut Run, 974 Centre Road, Wilmington, Delaware 19807 ("DPC")
and
President and Fellows of Harvard College, with offices located at Office for Technology and Trademark Licensing, Holyoke Center, Suite 727, 1350 Massachusetts Avenue, Cambridge, Massachusetts 02138 ("LICENSEE").
[NOTE: In 2001, Bristol-Myers Squibb Company (BMS) acquired DuPont Pharmaceuticals Company (DPC) and thus this agreement is now with Bristol-Myers Squibb.]

RECITALS

WHEREAS, DPC has certain rights in and to certain Cre-Lox Technology (as defined below) involving site-specific recombination of DNA in eukaryotic cells; and
WHEREAS, LICENSEE is desirous of obtaining a research license under the Licensed Patents (as defined below) to use the Cre-Lox Technology under the terms and conditions set forth herein.
NOW, THEREFORE, in consideration of the above premises and the mutual covenants contained herein, the parties agree as follows.

1. DEFINITIONS

The terms in this Agreement with initial letters capitalized, whether used in the singular or the plural, shall have the meaning set forth below or, if not listed below, the meaning designated in places throughout this Agreement. LICENSEE and DPC are sometimes referred to herein individually as a party and collectively as the parties.
1.1 "Cre-Lox Material" means any material covered by Valid Claim within the Licensed Patents, including but not limited to (i) any eukaryotic organism or cell containing DNA capable of expressing a Cre recombinase protein and/or containing lox DNA or (ii) any DNA or RNA vector capable of expressing a Cre recombinase protein in a eukaryotic cell and/or transferring lox DNA into a eukaryotic cell; provided however, that Cre-Lox Material shall not include any higher plant or plant cell or any vector designed for expression or transfer of Cre or lox into any higher plant or plant cell.
1.2 "Cre-Lox Technology" means all inventions described, embodied by and claimed in the Licensed Patents. The terms "Cre", "cre" and "lox" (also referred to as "loxP") as used in this Agreement have the meaning as described and embodied by the Licensed Patents.
1.3 "Effective Date" means the date indicated above as the effective date of this Agreement.
1.4 "Licensed Patents" means the United States and foreign patents and patent applications listed on Attachment A hereto, any continuation-in-part, continuation or divisional applications thereof, any patent granted on any aforesaid patent application, and any extension, revival, re-examination, or reissue of any of such patent, and any continuations, continuations-in-part, divisionals, reissues or extensions of any of the foregoing.
1.5 "Research Field" means use by LICENSEE for its internal non-commercial biomedical research purposes, provided however, that such research purposes specifically excludes (i) use of cre DNA and/or lox DNA in higher plants or agricultural applications, (ii) use of cre DNA and/or lox DNA in the alteration of mouse embryonic stem cells or other pluripotential mouse cells for the purpose of preparing a library of such mouse embryonic stem cells or other pluripotential mouse cells containing cre and/or lox DNA, and (iii) use of any material containing cre DNA and/or lox DNA which is encompassed by the Licensed Patents for any commercial purpose or for the benefit of any for-profit institution. Specifically excluded from the Research Field is the development, manufacture, use, lease, sale (or other transfer for consideration) or importation of any product for sale (or lease or other transfer of a product for consideration) wherein the manufacture, use, sale or importation of such product would infringe a Valid Claim of the Licensed Patents, including but not limited to wherein the product is manufactured using a composition or method which would infringe a Valid Claim of the Licensed Patents. Also specifically excluded from the Research Field is the use of any Cre-Lox Material to generate scientific data or information that is conveyed to a Third Party for consideration.
1.6 "Third Party" means any entity other than LICENSEE or DPC.
1.7 "Valid Claim" means a claim of an issued and unexpired patent which has not been held permanently revoked, unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal.

2. GRANT OF RIGHTS TO LICENSEE

2.1 Grant of Research License to LICENSEE. Subject to the terms and conditions of this Agreement, DPC hereby grants to LICENSEE a non-transferable, non-exclusive, worldwide field of use license under the Licensed Patents, without the right to grant sublicenses, to use the Cre-Lox Technology solely for use in the Research Field. The use of the Cre-Lox Technology outside of the Research Field is outside the scope of this Agreement and shall only be permitted under the terms of a separate written agreement between LICENSEE and DPC (or E.I. DuPont de Nemours, and Company). The license granted hereunder includes the right to make, use, breed and cross-breed (where applicable) Cre-Lox Materials solely for internal research purposes in the Research Field. LICENSEE shall have the right to transfer Cre-Lox Materials to third party non-profit institutions subject to Section 2.2 below. LICENSEE shall have the right to transfer Cre-Lox Materials to third party for-profit institutions subject to Section 2.3 below. LICENSEE shall have the right to receive Cre-Lox Materials from a Third Party subject to the terms and conditions of this Agreement.
2.2 Transfer of Cre-Lox Materials to Non-profit Institutions. LICENSEE may transfer Cre-Lox Materials it makes or acquires during the term of this Agreement to non-profit institutions, provided that:

• such non-profit institution has entered into a license agreement with DPC or E.I. DuPont de Nemours and Company granting rights under U.S. patent number 4,959,317, such licensed non-profit institution being identified in a list provided by DPC; or alternatively,
• such transfer is subject to a written material transfer agreement between LICENSEE and the non-profit institution having the terms set forth in Attachment B hereto, and
• no transfer of materials shall be made for consideration, other than reimbursement for the costs of producing and shipping the Materials to another non-profit institution.

2.3 Transfer of Cre-Lox Materials to For-profit Institutions. LICENSEE may transfer Cre-Lox Materials it makes or acquires during the term of this Agreement to Third Party for-profit institutions subject to the following: (a) the for-profit institution has entered into a written license agreement with DPC which expressly permits the for-profit institution to receive Cre-Lox Materials from third parties subject to the payment of a transfer fee to DPC and (b) prior to any such transfer to the for-profit institution, LICENSEE shall have received written confirmation from DPC that DPC has received payment of the applicable transfer fee for such Cre-Lox Material from the for-profit institution. LICENSEE shall not otherwise be permitted to transfer Cre-Lox Materials to any for-profit institutions. The transfer and use of the Cre-Lox Material by the recipient for-profit institution shall be subject to the terms and conditions of the license agreement between the recipient for-profit institution and DPC.
2.4 Non-assertion. During the term of this Agreement and so long as LICENSEE has not committed any material breach with respect to any obligation hereunder, neither DPC nor E.I. DuPont de Nemours and Company will assert any patent or patent application licensed hereunder against LICENSEE to prevent LICENSEE from practicing the rights granted to LICENSEE under Article 2 hereof.
2.5 No Other Licenses. No right or license is granted hereunder, except as expressly and specifically set forth herein.

3.GRANT BACK OF RIGHT TO DPC

3.1 DPC Access to Cre-Lox Material. Upon DPC's written request, LICENSEE agrees to provide to DPC without cost reasonable quantities of any Cre-Lox Material identified in a public disclosure that LICENSEE makes during the term of this Agreement, solely for DPC's internal research purposes.

4. REPRESENTATIONS AND WARRANTIES; LIABILITY

4.1 Representations and Warranties. DPC represents and warrants to LICENSEE that (a) it has all requisite power and authority to enter into this Agreement and to grant the licenses granted by it hereunder, (b) execution of this Agreement has been duly authorized, and (c) this Agreement is fully binding and enforceable in accordance with its terms. LICENSEE represents and warrants to DPC that (a) it has all requisite power and authority to enter into this Agreement and to perform its obligations under this Agreement, (b) execution of this Agreement has been duly authorized, (c) this Agreement is fully binding and enforceable in accordance with its terms, (d) that all of its activities related to its use of the Licensed Patents pursuant to this Agreement will comply with all applicable federal, state and local laws, statutes, rules and regulations and (e) that LICENSEE will not during the term of this Agreement enter into any agreements, contracts or other arrangements that would be inconsistent with its obligations under this Agreement. DPC recognizes that while LICENSEE will use its good faith effort to inform its faculty of the restrictions of this Agreement on an annual basis, LICENSEE cannot ensure that no violations by its employees will occur. LICENSEE agrees that the timely cure of any such violation is the responsibility of LICENSEE. Further, if LICENSEE becomes aware of violations, it will inform DPC and promptly seek to terminate those violations and will actively monitor the laboratory involved for the next year.
4.2 Liability. LICENSEE shall bear all risk and responsibility and liability for all of its activities in exercising its rights under this Agreement and shall hold DPC and its affiliates and parent companies harmless against any and all claims, demands, losses, costs, expenses (including attorney fees), damages and judgments whatsoever, arising out of or resulting from acts or omissions of LICENSEE in connection with the exercise of its rights under this Agreement. DPC shall not be liable to LICENSEE because of the infringement of any patent rights of any third party by LICENSEE in practicing the rights granted hereunder.

5. TERM AND TERMINATION

5.1 Term. This Agreement, unless terminated earlier, shall remain in full force and effect on a country-by-country basis until the expiration of the last to expire of any Valid Claim included in the Licensed Patents in such country.
5.2 Termination by DPC. DPC shall have the right to terminate this Agreement, at DPC's sole discretion, upon 60 days written notice to LICENSEE in the event that any material provision or stipulation of this Agreement shall have been breached by LICENSEE and in the event that LICENSEE shall have failed to remedy such breach within such 60 day period. Any notice served by DPC pursuant to this Section 5.2 shall specify the nature of the breach and the required remedy by LICENSEE.
5.3 Termination by LICENSEE. Subject to Section 5.4, LICENSEE shall have the right to terminate the license granted hereunder upon written notice to DPC.
5.4 Effect of Termination.
5.4.1 Upon termination or expiration of this Agreement for any reason all rights and licenses granted to LICENSEE hereunder shall terminate.
5.4.2 Survival. The termination of this Agreement shall not affect any rights or obligations of either party that have accrued or matured prior to termination and which are intended by the parties to survive termination.

6. OTHER PROVISIONS

6.1 Assignment. This Agreement may not be assigned or otherwise transferred by LICENSEE without the prior written consent of DPC. DPC may, without LICENSEE's consent, assign all or any portion of its rights and obligations hereunder in connection with the transfer of the Licensed Patents to a third party assignee or successor in interest, provided that such assignee or successor in interest agrees to be bound by the, terms of this Agreement.
6.2 Applicable Law; Jurisdiction. This Agreement is acknowledged to have been made in and shall be construed in accordance with the laws of the State of Delaware, without regard to conflict of laws principles which would dictate the application of the law of a different jurisdiction, provided, that, all questions concerning the construction or effect of patent applications and patents shall be decided in accordance with the laws of the country in which the particular patent application or patent concerned has been filed or granted, as the case may be.
6.3 Notices. Any notice or other communication pursuant to this Agreement shall be sufficiently made or given on the date of mailing if sent to such party by facsimile on such date, with paper copy being sent by certified first class mail, postage prepaid, or by next day express delivery service, addressed to it at its address below (or such address as it shall designate by written notice given to the other party).
If to DPC: [contact information; now to BMS]
If to LICENSEE: [contact information]
6.4 Relationship of the Parties. It is expressly agreed that the relationship between LICENSEE and DPC shall not constitute a partnership, joint venture or agency. Neither LICENSEE nor DPC shall have the authority to make any statements, representations or commitments of any kind, or to take any action, which shall be binding on the other, without the prior consent of the other party to do so.
6.5 Severability. In performing this Agreement, the parties shall comply with all applicable laws. Wherever there is any conflict between any provision of this Agreement and any law, the law shall prevail, but in such event the affected provision of this Agreement shall be limited or eliminated only to the extent necessary, and the remainder of this Agreement shall remain in full force and effect. In the event the terms of this Agreement are materially altered as a result of the foregoing, the parties shall re-negotiate in good faith the terms of this Agreement to resolve any inequities.
6.6 Counterparts. This Agreement may be executed in counterparts with the same effect as if both parties had signed the same document. All such counterparts shall be deemed an original, shall be construed together and shall constitute one and the same instrument.
6.7 Entire Agreement. This Agreement, including the Attachments hereto, constitutes the entire agreement between the parties with respect to the subject matter hereof, and supersedes any and all oral and/or written communications or understandings relating to the subject matter hereof.
IN WITNESS WHEREOF, the parties have caused their duly authorized officers to execute and deliver this License Agreement as of the Effective Date.
[Signature for DuPont Pharmaceuticals Company]
[Signature for Harvard University]

ATTACHMENT A

ATTACHMENT B

(Attachment B contains the template of the Cre-Lox MTA. See the MTA for Cre-Lox Materials.)