1 Research Administration 101: Series Three - Agreement Types Tammy Kuhn Martin Research...

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Research Administration 101:Series Three - Agreement Types

Tammy Kuhn Martin Research

Administrator College of Engineering

Dean’s Office

Stephen G. Harsy, PhD Assistant Dean for Technology

Transfer School of Medicine and Public Health

Dawn Herrick Research

Administrator College of Engineering

Dean’s Office

Research Administration 101:

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Overview of Today’s Topic

Agreement Relationships

Research Funding Mechanisms

Non-Funded Agreements

Terms & Conditions - Key Issues

Agreement Process & Examples


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Sponsored Research Projects• What is it?

– A project funded by an award from a grant, contract, or cooperative agreement under which the UW agrees to perform a certain scope of work, according to specified terms and conditions, for a specific budget.

– A sponsored project requires detailed financial accountability and compliance with the sponsor’s terms and conditions.

Sponsored Research Projects

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Terms & Conditions - Key Issues



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Types of Research Funding Mechanisms

• Agreements/Contracts

• Grants

• Gifts

Types of Research Funding Mechanisms

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Agreement/Contracts

• Sponsored Research Agreements

• Cooperative Agreements

• Clinical Trials

• Fee for Services

Agreement/Contracts

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Types of Sponsored Research Agreements• Fixed Price

– Projects that have a total price that has been accepted by both parties, regardless of the actual costs incurred by the UW

– An agreed upon payment schedule based either on milestones or dates• UW prefers 60,30,10 split

– Nonrefundable

– Does not require a financial report of how the UW spends the project budget

Types of Sponsored Research Agreements

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• Cost Reimbursable– Projects that have a price accepted by both

parties based on the actual expenses incurred by the UW

– – Payment based on invoices, financial

reports, or both that show expenses incurred by the UW

– If UW does not spend up to the approved budget, we don’t receive all the money


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Examples of Sponsored Research Agreements

• Industry• Federal Contracts/Agreements• Education Institutions• Other Governmental Entities

Examples of Sponsored Research Agreements

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University’s Standard Research Agreement

• Developed by the UW for industrial sponsored research, but can be used for all sponsors

• Use of this agreement, without alteration, eliminates the need for negotiation between the UW and the Sponsor

• Often used as a template to initiate the negotiation process

University’s Standard Research Agreement

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Clinical Trials

• Sponsor pays UW to test the safety or efficacy of a treatment which could include a drug, device, diagnostic or procedure on humans

• Usually driven by FDA regulatory requirements (Phase I, II, III, IV)

• Not all human subjects research is a clinical trial

Clinical Trials

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Fee for Service

Fee for Service is NOT RESEARCH Routine work with minimal intellectual

input Execution of a pre-defined or repetitive process Production of a product that meets pre-defined

specifications Does not involve the creation or dissemination

of new knowledge, or scientific advancement in a field

Standard pricing Personnel-in-training not involved

Fee for Service

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Fee for Service (cont.)

Contract terms No publication Secrecy of results No retention of ownership of data

Requirements128 or 136 account establishedPricing covers costsAccounting procedure are auditableProposed project within 128/136 definition

Fee for Service (cont.)

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• Sponsor Research Agreements

• Grants

• Gifts


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Grants

• A type of funding mechanism awarded to the UW for the conduct of research or other program as specified in an approved proposal

• A grant is used whenever the awarding office anticipates no substantial programmatic involvement with the UW during the performance of the activities

Grants

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Grants

• Simple terms– Project Dates– Award Amount– Payment terms– Performance ReportsNOTE: Most Grants will say they are a Grant (i.e. Notice of

Grant Award)

• Examples – Federal Government– Foundations/Non-Profits

Grants

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Grants & FDP

• Federal Demonstration Partnership– The Federal Demonstration Partnership (FDP) is

a cooperative initiative among federal agencies and institutional recipients of federal funds.

– It was established to increase research productivity by streamlining the administrative process and minimizing the administrative burden on principal investigators while maintaining effective stewardship of federal funds.

• Benefits from FDP – Ninety-day pre-award spending – Institutionally approved no-cost extensions up

to one additional year– automatic carryover of unobligated funds from

one budget period to the next. – Specific agency benefits can be found on RSP’s

website. http://www.rsp.wisc.edu/awardmgt/fdpnondefense.html

Grants & FDP

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• Sponsor Research Agreements

• Grants

• Gifts


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Gifts

• What makes it a GIFT?– Five requirements to be a gift

• Supports broadly defined activities• No detailed technical reports required• No rights to IP claimed by donor• No restrictions on publication or use of results• Irrevocable

• UW’s Gift Policy (http://www.rsp.wisc.edu/policies/uwfoundation.html)

Gifts

http://www.rsp.wisc.edu/policies/uwfoundation.html

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Gifts

• Given directly to UW• University of Wisconsin Foundation

– Examples of who give gifts to UW• Industry • Individual

– Examples of gifts we can’t accept• Government • Educational Institutes

Gifts

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Non-Funded Agreement

Terms & Conditions – Key Issues



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• Federal Government• Industry• State & Local Government• Other Institute of Higher Education• Non-profit & Foundations


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Federal

• Majority of research funding that UW receives comes from the Federal Government through Grants.

• When UW does receives a Federal Contract there are additional terms that we need to review and negotiate if necessary and the University has to sign the contract.

– Examples • FAR Clauses• Specific Deliverables

Federal

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Industry

• The majority of the research funding that we receive from Industry is in the form of an agreement or contract.

• This type of an agreement consumes the most effort to bring a project to UW.

– Industry wants to make a profit– UW’s mission is to create and disseminate

knowledge

Industry

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State & Local Government•As a state agency, UW receives funding from the state

•Specific arrangements set up with other state agencies

Inter-Agency Agreement Purchase Order Work OrderShared Grant (other UW System Colleges)

UW also receives funding from cities & counties in Wisconsin. There are no standardized arrangements set up with them.

State & Local Government

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Other Institutes of Higher Education

• Will provide a standard agreement for the project. If they don’t have one, UW’s Standard Research Agreement can be used.

• If University/College is a member of FDP, they will provide the standard FDP subagreement.• Need to make sure no additional terms are

added to the FDP Agreement. • Some University’s might have specific items

that they want that are outside the FDP terms.

Other Institutes of Higher Education

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Non-Profits & Foundations

•Provide the UW with a signed letter grant and if UW accepts grant conditions we counter sign.

PurposePeriodConditionsReporting

•Similar goals or mission of UW – interested in the results of the research and making it know to the public.

Non-Profits & Foundations

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Agreement Examples


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Communication and compromise

are key.

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• UW Policy– Intellectual Property– Data Use and

Ownership – Publication– Confidentiality– Guaranties

• State Law– Insurance– Publicity– Indemnification– Jurisdiction

So what do those Terms mean anyways…So what do those Terms mean anyways…

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• What is it?• What are the

UW rules?• What can we

accept in an Agreement– Federal vs

NonFederal

Intellectual PropertyIntellectual Property

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Intellectual Property

• What is it?– Patentable

inventions: a process, device, or composition of matter

– Copyrightable works: writings, software


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• Federal law allows UW to claim title to own patents created using federal funds - Bayh-Dole Act

• UW Patent policy - Faculty own inventions created in the course of their research activities, with UW retaining a license for educational and research purposes unless Federal funding has contributed to creation/development of invention


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Who owns IP?

• If invention is federally funded, university has first option to own; if we don’t want it, it belongs to feds

• If work is funded exclusively with non-federal sources, faculty owns inventions unless a contract says differently

• Faculty own copyrightable works in most cases, unless a contract says differently

Who owns IP?

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Industry-Sponsored Research

• Preferred Position– UW ownership of faculty invention– Sponsor has option to negotiate a royalty-

bearing commercial license to UW inventions

• If first pass unsuccessful, a variety of approaches are tried – life gets complicated

Industry-Sponsored Research

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Data Use and Ownership

• UW does not surrender ownership of research data produced by its faculty, staff or students.

• UW must own the results of its research for educational and research purposes.

• Sponsor may receive copies of data.

• Sponsor may use data as long it use does not conflict with IP rights and right of PI to publish.

Data Use and Ownership

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Publication

• A primary mission of UW is to discover and disseminate knowledge.

• UW will protect confidential information received from a sponsor, it cannot enter into an agreement which obstructs public access to information derived from faculty research.

• Sponsors may have short period of time (no longer than 90 days) to review the pending publication to: Identify any patentable discoveryRemove company confidential information

Publication

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Confidentiality

– UW does not perform Classified Research

– UW will keep confidential any proprietary information that it receives from a sponsor, but UW results are not confidential

– UW also cannot keep Confidential the existence of the Agreement• WI Open Records laws• Public University

Confidentiality

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Guaranties

• Since state-of-the-art research is by nature unpredictable and without guarantee of success, UW research is conducted on a reasonable-efforts basis.

• Since it is inconsistent with the reasonable-efforts principle, the UW cannot accept contract provisions that impose penalties for failure to make progress or provide for withholding of payment if the sponsor is not satisfied with the results.

Guaranties

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• Insurance• Publicity• Indemnification• Jurisdiction

State LawState Law

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• UW is self-insured – The parameters are set by state law – UW has no authority to indemnify

outside parties – UW cannot name a third party as an

additional insured – UW cannot provide a certificate of

insurance as the term is ordinarily understood

InsuranceInsurance

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• UW must be able to report contracts to the Regents and comply with public records requests

• UW cannot keep confidential the existence of a research collaboration or of contract, or its terms

• UW cannot keep confidential the outcomes of UW research

PublicityPublicity

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Indemnification

• UW can indemnify a sponsor only for liability for acts or omissions by UW employees, agents or officers while acting within the scope of their employment and as allowed by Wisconsin Law.

Indemnification

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• Jurisdiction is the power of a court to compel a party to appear, and to impose a judgment on that party after providing due process (usually in another state).

• Cannot agree in contract to jurisdiction or court of any state other than Wisconsin.

JurisdictionJurisdiction

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• Any agreement where no funding is being provided to the University

– Examples include: • Memorandums of Understanding• Confidential/Non-disclosure Agreement• Collaboration Agreement• Materials Transfer Agreement• Licensing Agreement• Software Agreement• Data Use Agreement


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Confidential & Non-Disclosure Agreements

• Agreement to keep information transferred from one party to another secret

• Often preliminary to establishing research relationship

• Must be signed by UW• It should not have Publication, Copyright or

Ownership language• Flavors

– One-way– Two-way (Mutual)– University– WARF

Confidential & Non-Disclosure Agreements

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Material Transfer Agreements

• Is an agreement that define the obligations each party undertakes when a research material is transferred from one organization to another.

• Transfer of materials can be achieve in one of two ways.


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• UW PI is receiving materials Required– Sponsor provides compound, drug, biological

material, cell line, mice, etc. for use in UW research

– UW provides funding for the research– Materials often highly proprietary

• UW PI is sending materials out – UW investigator provides material to sponsor– May need WARF management


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Other Transfer Agreements• Software

– Often takes the form of a no-cost software license

– May involve UW evaluation of utility and performance of software

• Data Use Agreements– UW wants access to data owned by

someone else– Sponsor may put limits on its use, seek

access and rights to results


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Collaboration Agreements

• Both parties agree to contribute resources and work together to find an answer to a particular research inquiry– Materials & equipment– Personnel, or specialized expertise to the project

• Agreement involves no transfer of money.

• Examples of Collaboration Agreements – Consortium Agreements– Memo of Understanding Agreements

Collaboration Agreements

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The Review and Negotiation Process at UW

Upload the Agreement to WISPER record and

sent to Dean’s Office

The Dean’s Office reviews and routes the record to RSP

RSP reviews the

agreement and identifies

any issues that need to be changed.

RSP will send Red-

line to Sponsor to

start Negotiations

Once negotiations are completed, the

Agreement is signed.

Once the Agreement is

fully executed, a project number is establishedPI receives

the Agreement directly

If changes are needed to IP,

the Agreement

may be sent to WARF for

review

If changes specific to PI or the project are needed, may send back to Dean’s office for approval

Agreement ProcessAgreement Process

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The Review and Negotiation Process for the School of Medicine and Public Health and the College of

Engineering

Upload the Agreement to WISPER record and

sent to Dean’s Office

The Dean’s Office reviews and red-lines

the Agreement with any

changes that we need

If changes are needed to IP, the

Agreement may be sent to WARF for

review

Send red-line Agreement to RSP for

any additional changes needed

Dean’s Office will send Red-

line to Sponsor to

start Negotiations

Once negotiations are completed, the

Agreement is signed.

Once the Agreement is

fully executed, a project number is establishedPI receives

the Agreement directly

Agreement ProcessAgreement Process

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Agreement Examples

• Master Agreement• Research Agreement• Federal Contract• Clinical Trial Agreement• Confidentiality/Non-Disclosure

Agreement• Materials Transfers Agreement

Agreement Examples

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• Websites – Research and Sponsored Programs

• www.rsp.wisc.edu

– WARF (Wisconsin Alumni Research Foundation)• http://www.warf.org/

– The Graduate School• http://

info.gradsch.wisc.edu/research/ip/index.html

Resources Resources

http://www.rsp.wisc.edu/

http://www.warf.org/

http://info.gradsch.wisc.edu/research/ip/index.html

http://info.gradsch.wisc.edu/research/ip/index.html

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Agreement Types

Questions?Questions?

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