Material Transfer Agreements CALS Research Division http://www.cals.wisc.edu/research/ May 17, 2007

Overview: What is a Material Transfer Agreement? Incoming Material Transfer Agreement Outgoing Material Transfer Agreement Understanding agreement issues, concerns and potential problems Components required before routing UW-Madison routing, review and approval process Questions/suggestions

What are Material Transfer Agreements? MTAs are contracts defining the respective rights and obligations of the Provider and the Recipient of materials used in research Biological materials such as genetic constructs, plasmids, proteins, DNA, cell lines, seed lines, plant germplasm, organisms (mice) Chemical compounds or polymers, potential new drugs Software programs and tools

Incoming Material Transfer Agreement Materials provided TO a recipient scientist by any party, including an academic or non-profit institution, a federal laboratory or government agency, a for-profit company, an industrial research laboratory or hospital laboratory, or even another investigator at the same institution

From Educational & Non-Profit Sources Under UBMTA (Uniform Biological Material Transfer Agreement) Implementing Letter, a short form used when parties are signatories to this 1995 agreement for exchange of materials for non-commercial purposes, its use confirms that recipient has signed the UBMTA and accepts material under UBMTA terms and conditions (signatories listed at Association of University Technology Managers site) http://www.autm.net/aboutTT/aboutTT_umbtaSigs.cfm

From Educational & Non-Profit Sources If a non-profit institution is a non-signatory or elects not to utilize the Implementing Letter, the same UBMTA definitions and terms are expanded upon via additional text in Simple Letter Agreement for Transfer of Materials See RSP “Principal Investigators’ Guide to Material Transfer Agreements” for more information and to download forms http://www.rsp.wisc.edu/awardmgt/mta.html

Incoming from For-Profit Entities Industry/company for-profit providers usually utilize their own MTA templates, delineating terms and conditions that protect and advance their commercial interests UW-Madison accepts these as an initial negotiating point; finalizing mutually agreeable terms can be a lengthy process

Outgoing Material Transfer Agreement Materials sent FROM a providing scientist at UW-Madison to an off-campus recipient at another academic or non-profit institution (or on same campus) UBMTA ‘Implementing Letter’ or ‘Simple Letter of Agreement’ used Materials sent to a for-profit company/industry ‘Simple Letter of Agreement’ is preferred template

Outgoing MTA if IP Assigned to WARF If material to be transferred is identified as intellectual property that is part of a pending or issued patent under WARF management, or is assigned to WARF as a “biological material,” follow WARF guidelines for required material transfer agreement: http://www.warf.org/inventors/index.jsp?cid=17&scid=21

Outgoing MTA, For-Profit Entities Absent any other constraints on distribution and absent WARF assignment of rights to the material, CALS Research Division will work directly with a researcher to craft an agreement allowing the material to be shared with a business/ industry recipient. Such will be grounded in UBMTA terms. CALS requires that an outgoing MTA be in place prior to a researcher sending materials to any off-campus recipient party.

Conflicting Missions in MTAs Industry seeks to enhance & defend its commercial interests, intent upon offsetting risks by acquiring and protecting exclusivity in the market (under patent law or by use of trade secrets), securing rights to inventions using its materials. Academic institutions seek to preserve the flow of ideas for public benefit, and to preserve the potential for new knowledge to generate a product from which the public can benefit.

MTA Goal: Balancing Act A Material Transfer Agreement attempts to balance university goals: Help investigators acquire materials to advance research Allow timely publication Facilitate public stewardship of invention for public benefit--Bayh-Dole provisions Protect investigator’s freedom to pursue future, related research problems Assure that institution can meet its contractual obligations

MTAs regularly address: Conditions for control of the proprietary information (allowed material use and transfer limits) Publication rights and dissemination of research results Future intellectual property rights (ownership, licensing opportunity) Confidentiality Limits to liability and warranties (insurance, indemnification)

How are MTAs beneficial? Promote university collaborations & expand scientific discovery Avoid disputes regarding material use Protect IP developed while using materials Protect publication rights Avoid limiting future research Allow access to industry technology to advance research Promote university-industry collaborations that could lead to sponsored research

Concern: Restricting Academic Freedom Agreement language may give provider control of publication, and may assert that nothing can be published or disclosed without provider approval; may demand excessive delays to publication (60-90 days) University publication policy: knowledge generated with donated material must be publishable Acceptable delay: 30 days for provider review/comment Additional 60 days to allow protection of provider IP Or any combination <= 90 days

Concern: Ownership Rights Providers may assert ownership not only to the physical material being provided, but also to new materials created by the recipient or inventions made through use of the provided materials. In a proposed agreement, “material” may be defined to include confidential information about the material as well as the forms of the material which may arise from replication and maintenance in the recipient laboratory (progeny, derivatives) If accepted, such terms may cause recipient to lose control of his/her own creations, including inventions and intellectual property. Recipient could be unable to continue a line of research inquiry due to relinquished ownership of research results.

Concern: Licensing Rights to IP When a company makes materials available for use in university research, it usually expects some access to resulting intellectual property. Terms which give the provider licensing rights to resulting IP must be crafted to ensure that the rights of research sponsors are protected, the licensee company will diligently develop the intellectual property for public use, and the university receives fair compensation for its contribution.

Concern: Obligations to Funding Sponsors Since the provider of materials is most often not funding the research, the university needs to ensure that its intellectual property obligations to the sponsors who are funding the work do not conflict with the proposed obligations to the provider of the material. If under federal funding, the rights of the federal government regarding inventions made with the material may need to be clearly acknowledged in the agreement.

Data Ownership Per UW policy, no agreement shall be entered into with any extramural sponsor which allows for the transfer of the ownership of data. (This does not apply to proprietary data originally belonging to a sponsor.) Material provider can receive a copy of UW data for internal research and development purposes, or a copy of data in report context.

Confidentiality Issues Information shared along with material by a provider will be protected as confidential by UW if at time of disclosure the information is identified in writing as confidential the duration of the confidentiality requirement is reasonable (2-5 years)

Legal Issues UW will accept liability only to the extent allowed under Wisconsin law. Wisconsin law does not allow indemnification of other parties to an agreement. “indemnification” is basically releasing the provider from responsibility to make good on damage occurring as a result of provider action or inaction, holding the provider harmless, a shifting of economic responsibility to the recipient No court can have jurisdiction over UW unless the state legislature determines to accept that court’s authority.

Special Shipping Requirements USDA import regulations may cover biological materials from overseas sources, in some cases requiring permits e.g., CDC permit for human pathogens; USDA & CDC permits for any pathogen or vector of disease US shipment of biological materials is regulated by multiple agencies. Specialized packaging, shipping papers, permits or licenses from government agencies may be required http://www2.fpm.wisc.edu/biosafety/shipping_hazmat/regulations.htm

Components Required Before Routing PI/Department responsibilities: Procure two original copies of an MTA Procure an electronic file copy of the MTA document, for use in RSP review and term negotiations (not needed for UBMTA-related agreements) Provide contact information (name, e-mail address, FAX and phone numbers, mailing address) for the other institution/industry technology transfer office and for the party with whom you have been working (scientist, administrator)

More Components Required (PI/Dept) Designate the source of funding that will support research using the materials requested (144-xxxx; 133-xxxx) Prepare transmittal form; include submission instructions (prepaid express shipping label, US mail, fax transmission) Check to see if PI signature is requested on the agreement signature page; the PI often signs as Recipient Scientist or Recipient Investigator for incoming MTAs and as Provider Scientist for outgoing MTAs

PI’s Name & Signature for Entire Lab Agreements may request signature from Recipient Scientist or Recipient Investigator to acknowledge understanding and acceptance of agreement terms. Only the principal investigator (as faculty member, grants manager, and advisor/mentor to graduate students and postdocs) can be named and can sign in this “Recipient Scientist/Investigator” role. (not lab Scientists, Researchers, or any other positions) When grad students/postdocs complete MTA requests online, e.g. from Addgene Plasmid Repository, ALWAYS USE the faculty PI name and contact information.

Formal Party to an MTA The institution, and not an individual faculty member or department, is the formal party to any agreement. The MTA “Recipient” or “Recipient Institution” should be indicated as: Board of Regents of the University of Wisconsin System, on behalf of the University of Wisconsin-Madison, a public educational institution located at 21 North Park Street, Suite 6401, Madison, Wisconsin 53715-1218

Authorized Institutional Signatory The “authorized institutional signatory” role is filled by Research & Sponsored Programs, with the authority to commit The Board of Regents to an agreement on behalf of the requesting faculty member. Strictly speaking, Diane Barrett as Assistant Director, Pre-Award Services serves as our authorized institutional official. Others at RSP are authorized to sign on institution’s behalf.

CALS Research Division Role Review T-form and documentation Review for conflicts with funding source May negotiate terms with Provider May consult with WARF regarding IP position Communicate with Research & Sponsored Programs, working together to establish desirable agreements

RSP Role Final review of documentation Negotiation of terms with Provider, if needed Negotiation of IP position, with WARF input as necessary Signature on behalf of Board of Regents Distribution of fully executed agreement

Responsible Actions Make sure that an MTA is fully in place before receiving materials from an outside source. If materials ARE received before an MTA is in place (which can occur) please WAIT to use them in research until an agreement is in place. Serious conflicts over intellectual property ownership may result if work is performed under the belief that an agreement is in place--only to later learn that UW was unable to accept the proposed terms.