Brown-Bag Lunch and Learn
Corporate Contracts Update &
Agreement Types
July 24, 2009
Adam P. Rifkind, Esq., Associate Director
Kathryn Steinbugler, J.D., Director
Corporate Contracts
Office of Research Services
Corporate Contracts Update
Agenda:
 Provide Overview of Office of Research
Services;
 Share Plan for Enhancing Efficiency &
Service;
 Provide Overview of Agreement Types;
 Answer Questions; Collect Feedback.
Corporate Contracts Update
Office of Research Services
Pre-Award (Deb Fisher): Review,
Negotiation, Submission of Grant &
Contract Documents to Secure Funding
from Federal & Foundation Sponsors;
Negotiation of federally-funded corporate
contracts;
Corporate Contracts (Kathryn Steinbugler):
Review, Negotiation, Submission of Contract
Documents, to Secure Funding from Corporate
Sponsors; Commonwealth; City of
Philadelphia; Export Control Advise;
Post-Award Compliance (Bob McCann):
Facilities and Administrative Costs,
Employee Benefit Rates, Effort Reporting,
and Financial Compliance Issues;
Post-Award Financial Administration (Kim
Michelle Garrision ): Management of
Financial Reports, Project Invoicing (ex.
Clinical Trials); Accounting; Post-Award
Compliance Group; Support for Stewardship of
Funds by Schools/Centers, including reports to
Schools/Centers and Finance Management;
Managing Federally Required Financial Audit;’
Research Operations & Cash
Management (Keith Dixon): Data
Management and Reporting Regarding
Financial Status of Projects; Management
of ORS Systems; Account Set-Up for
Projects; Management of Letters of Credit,
Cash Receipts and Collections.
PennERA (Todd Swavely): Updates
and Operations of the PennERA
System.
Corporate Contracts Update
Plan for Enhancing Service & Efficiency: Mission of Corporate Contracts
To Enable World Class Penn Research by:
 Concluding Contracts for Research Efficiently, Effectively and Consistent with
Penn policies;
 Providing a High Level of Service to Faculty, BAs and other Stakeholders
Consistent with the Right Resources;
 Achieving a High Level of Faculty, BA and other Stakeholder Satisfaction with
Our Services;
 Collaborating Effectively with Our Colleagues Who Support Research at Penn;
 Providing a Stimulating, Respectful Work Environment that Enables
Professional Growth and Development Through Important, Challenging
Work.
OUR CURRENT STAFF AND ASSIGNMENTS
SRA
(OTHER
SCHOOLS)
MTA
OTHER
XX
XX
NAME AND TITLE
CTA
SRA
(SOM)
Michelle Buono, Administrative Assistant
XX
XX
XX
Benita Hall, Contract Administrator
XX
XX
XX
Matt Merz, MTA Administrator
Beth Alioto, Senior Contract Admin.
XX
XX
XX
XX
Laurance Guido, Senior Contract Admin.
Sheila Atkins, Associate Director
XX
XX
XX
Coy Purcell, Associate Director
XX
XX
XX
Adam Rifkind, Associate Director
XX
XX
XX
Brian Sharma, Associate Director
XX
Kerry Wilson, Associate Director
XX
SRA – Sponsored Research Agreement
MTA – Material Transfer Agreement
OTHER – Data Use, Non-Disclosure, etc.
XX
XX
Ed Pieters, Associate Director
CTA – Clinical Trial Agreement
XX
XX
XX
XX
XX
XX
Corporate Contracts Update
Factors that affect time to conclusion of contracts:
 Contentious issues – i.e.; Publication rights, subject
injury, indemnification, intellectual property;
 Unresponsive Sponsors;
 Volume;
 Incomplete submissions;
 Upstream review time vary.
Negotiations, unlike other processes affecting research, are
not completely within our control
Corporate Contracts: Plan for Enhancing Services and Efficiency
Completed Items
ENHANCED COMMUNICATIONS:
•Initial outreach from negotiator to PI & BA;
•Regularly-scheduled staff meetings;
•ORS Advisory Committee collaboration to develop detailed plan;
•Weekly meetings with OGC aimed at trouble-shooting issues pertaining corporate
contracts;
•Faculty Feedback Mechanism in use for CTAs and SRAs.
OPTIMIZED RESOURCES:
•Additions to headcount – New associate director, senior contracts administrator,
administrative associate all on board;
•Established back-up system to provide continuous coverage;
•Collaboration with Clinical Research Administration workgroup regarding process
improvements for Clinical trials.
ENHANCED TRANSPARENCY:
•PennERA proposal development enables PI’s staff to view status;
•Additional metrics for key points in process established;
•Enhanced reports using currently available metrics developed; new metrics added
to PennERA;
•CTSA Corporate Contracts pilot study begun.
ENHANCED CONTRACTUAL POSITIONS:
•Fallback Positions for Negotiations of Clinical Trial Agreements Finalized.
Activities Supported by Corporate
Contracts
 Sponsored Projects/Research;
 Clinical Trials (a specific type of
sponsored research);
 Transfer of Materials;
 Confidential Disclosures;
 Data Use Agreements.
Activities Supported by Corporate
Contracts
Sponsored Research—Characteristic Features:

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Commitment to pursue a line of scholarly inquiry, typically
described in a statement of work;
Commitment regarding level of personnel effort, deliverables,
and milestones;
Project activities are budgeted, and the award includes
conditions for specific reports, and/or invoicing;
Typically, unexpended funds are returned to the sponsor at the
end of the project period;
The award/agreement specifies who acquires rights to property
(e.g., inventions, copyrights or rights in data) which may
result from the project; and
A period of performance is specified as part of the
award/agreement.
Activities Supported by Corporate
Contracts
Clinical Trials—Characteristic Features:

Commitment to enroll subjects in a study of safety or efficacy of an
intervention to diagnose, treat or prevent disease under a defined
protocol;

Protocol may be designed by sponsor or faculty researcher;

Budget based on specific enrollment milestones; upfront payments
included for start-up; generally, a “fixed price” contract;

Inventions anticipated by the protocol are property of sponsor for
sponsor-designed protocol;

Period of performance specified in award/agreement; may be subject
to shortening due to enrollment at other sites.
Activities Supported by Corporate
Contracts
Transfer of Materials—Characteristic Features:
 Biological or chemical materials coming into or
going out of Penn;
 Areas that need to be addressed:
 Inventions;
 Access to data resulting from research; rights to
publish research results;
 Potential liability from exposure to the materials as
well as from use of the results of the research.
Activities Supported by Corporate Contracts
Confidential Disclosures – Characteristic Features:
 Proprietary information from a sponsor or from the University may need
to be
shared to evaluate possible project;
 Information typically shared on a “need-to-know” basis, marked
“confidential”, used only for specified purpose and returned when
the purpose has been served;
 Principal Investigator or University and PI may take on the obligation to
protect confidentiality, depending on the situation.
Contact Information:
 Confidentiality Agreements for addressing protocols in advance of
clinical trials are handled by Piera Chodorow
(pichodor@mail.med.upenn.edu) in the Office of Corporate
Alliances;
 Confidentiality Agreements relating to intellectual property are handled
by Helene Hunt (helenem@ctt.upenn.edu) in the Center for
Technology Transfer;
 Other research related Confidentiality Agreements are handled by Beth
Alioto (bmarie@upenn.edu) in the Office of Research Services.
Use of Protected Data
Use of Protected Data -- Characteristic Features:
 HIPPA allows for one category of protected data to be
used for research, public health or health care
operations purposes without individual authorization
when a data use agreement is signed;
 Data use restricted for a specified purpose;
 Approved form on SOM website;
http://somapps.med.upenn.edu/ohr/formslibrary/i
ndex.php?r=HIPAA; University signature
needed.
What is a Gift?
• Voluntary transfer of things of value – cash,
checks, securities, real or personal property.
• May come from individuals, corporations,
foundations or other sources.
• No contract or agreement involved - unilateral
• May be for restricted or unrestricted use.
• May be used for operations, capital or
endowment.
Grant or Contract, why does it matter?
• Different obligations of researcher / Penn
– Financial reporting
– Programmatic reporting
– Invoicing
• Different limitations and restrictions on the use of
funds
– Such as, freedom of deviation from budget
• Different level of detail in scope of work and how
closely research must adhere to scope of work
Grant
• Purpose:
– To transfer…
• Money
• Property
• Services
• Or anything of value
…to recipient in order to accomplish a public or
private purpose.
• Involvement:
– No substantial involvement is anticipated between
Sponsor and recipient during the performance of
activity.
Contract
• Definition:
Written memorialization of an agreement by two or
more parties to exchange property, services and/or
money.
• Purpose:
To acquire property or services for direct benefit or
use of the Sponsor.
• Involvement:
Varying amounts anticipated between Sponsor and
recipient during performance of activity.
Grant vs. Contract
Grant
Investigator
Project
conceived by:
Sponsor
function:
Control:
Supports or
assists
Sponsor
oversight:
Maintains
cognizance
Contract
Sponsor
Procures service
Performer defines Sponsor exercises
details and retains direction or control
scientific freedom
Closely monitors
Federal grants/Federal contracts
• Grant awards usually reference the grant policy
of the agency; some conditions specific to the
award noted in award documents;
• Contracts usually enumerate specific provisions
and may also reference FAR clauses (including
DFAR and HHSFAR, etc.)
Cooperative Agreement
• Purpose:
To transfer funds to recipient to accomplish a public
purpose. Another Federal funding mechanism
• Involvement:
Substantial amounts anticipated between Sponsor
and recipient during performance of activity.
Collaborative Agreement
• Purpose:
To work together on research in a manner that
complements the strengths of each party.
• Involvement:
Substantial involvement by both parties in the research
Agree to publish together, but both retain scientific
freedom
• Non-monetary – each pays for own expenses
RFQuotation
RFProposal
RFApplication
• Sponsor generates scope of work via
Notices/Program Announcements.
• You respond with how you will accomplish, budget
and time frame.
• Contract is usual award document for RFP/RFQ
while a grant/cooperative agreement is usual award
document for RFA.
• RFP, RFQ, and RFA are often used interchangeably
by the government and in the field, so the term
should not be the sole determinant to whether we are
dealing with a grant or contract.
Grant
Cooperative
Agreement
Contract
Basic Purpose
Provides assistance
with few restrictions
Provides assistance
with substantial
involvement
between parties
Procure tangible
goods and services
Solicitation
method
Application kit or
guidelines
Request for
application (RFA)
Request for
proposal or quote
Award instrument
Short – may refer to
general conditions
Describes
involvement, party
relationships
Detailed specs,
clauses, regulations,
expected results
Sponsor
involvement and
oversight
Generally no
involvement, little
oversight of actual
work
Substantial
involvement and
oversight
Substantial
oversight, varying
degrees of
involvement
Rebudgeting
Flexible
Usually flexible
More restrictive
Grant
Cooperative
Agreement
Contract
Equipment title
Grantee
Varies
Varies
Performance
period
Specified
Specified
Specified
Patent rights
Generally liberal
May be involved
Specified in contract
Publication
May ask to be
informed
May ask to be
informed
May require prior
review and/or
approval
Technical
Annual summary
Frequent reports
Detailed, frequent,
may be based on
deliverables
Groups in ORS responsible for research
award reviews and agreement negotiations
Pre-award Services Group
Corporate Contracts Group
(reviews all awards, negotiates
for the following sponsor types)
(negotiates for the following sponsor
and agreement types)
Federal Sponsors – grant,
contract, cooperative agreement
Corporate (for-profit) sponsors
Clinical trials – corporate sponsors
Subcontract with government or
non-corporate sponsor as prime
Foundations and other nonprofits
Subcontracts when prime is
corporate or when both government
& industry funds involved, preaward and corporate contracts
collaborate
Data use agreements, Material
transfer agreements
Other governments except*
*Negotiates contracts following
awards from Commonwealth of
Pennsylvania or City of Philadelphia
Agreement Review Forms
• For agreements in which Sponsor agrees to fund Sponsored
Research, we use Proposal Development in PennERA for most
purposes, though the Proposal Transmittal and Approval Form is
sometimes used to revise, amend, or supplement an award:
http://www.upenn.edu/researchservices/pdfs/transmittalform0904.pdf
• For agreements related to research in which there is no provision for
funding:
http://www.upenn.edu/researchservices/docs/Non-monetaryreview.doc
• For confidential disclosure agreements used to disclose clinical trial
protocols to School of Medicine researchers to gauge their interest
in conducting a study, please see Kelly Curran, Office of Corporate
Alliances, (215) 573-6102, curranks@mail.med.upenn.edu
• For the review of material transfer agreements:
http://www.upenn.edu/researchservices/materialtransfer/MTA%20Submissio
n%20Form_111407.doc
Corporate Contracts Update
How You Can Help Us Help You:
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Ensure understanding of the process;
Help us educate faculty as needed to resist temptation to
sign agreements without University review;
Provide complete information with initial submission (e.g.,
sponsor contact information; conflict of interest certification);
Ensure accuracy of information; nip any errors in the bud;
Provide background relevant to agreement (e.g., agreement
templates provided by sponsor; related agreements);
Assist in enlisting help of your contacts at Sponsor;
Partner with us in communications with sponsor;
Provide ongoing feedback.
Corporate Contracts Update
Questions? Comments? Feedback?
Benita Hall
benitah@upenn.edu
215 573 6709
Adam Rifkind
rifkind@upenn.edu
215 898 9990
Kathryn Steinbugler
kathryns@upenn.edu
215 573 9970