Agreement Contracts Enrollment

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					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,              Corporate Contracts (Kathryn Steinbugler):
Negotiation, Submission of Grant &           Review, Negotiation, Submission of Contract
Contract Documents to Secure Funding         Documents, to Secure Funding from Corporate
from Federal & Foundation Sponsors;          Sponsors; Commonwealth; City of
Negotiation of federally-funded corporate    Philadelphia; Export Control Advise;
contracts;

Post-Award Compliance (Bob McCann):          Post-Award Financial Administration (Kim
Facilities and Administrative Costs,         Michelle Garrision ): Management of
Employee Benefit Rates, Effort Reporting,    Financial Reports, Project Invoicing (ex.
and Financial Compliance Issues;             Clinical Trials); Accounting; Post-Award
                                             Compliance Group; Support for Stewardship of
                                             Funds by Schools/Centers, including reports to
                                             Schools/Centers and Finance Management;
Research Operations & Cash
                                             Managing Federally Required Financial Audit;’
Management (Keith Dixon): Data
Management and Reporting Regarding
Financial Status of Projects; Management
of ORS Systems; Account Set-Up for           PennERA (Todd Swavely): Updates
Projects; Management of Letters of Credit,   and Operations of the PennERA
Cash Receipts and Collections.               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
                                                  SRA     (OTHER
NAME AND TITLE                             CTA   (SOM)   SCHOOLS)   MTA   OTHER
Michelle Buono, Administrative Assistant   XX     XX       XX       XX     XX
Benita Hall, Contract Administrator        XX     XX       XX              XX
Matt Merz, MTA Administrator                                        XX
Beth Alioto, Senior Contract Admin.        XX     XX       XX              XX
Laurance Guido, Senior Contract Admin.                              XX
Sheila Atkins, Associate Director          XX
Ed Pieters, Associate Director                    XX       XX       XX
Coy Purcell, Associate Director            XX     XX       XX
Adam Rifkind, Associate Director           XX     XX       XX              XX
Brian Sharma, Associate Director           XX                              XX
Kerry Wilson, Associate Director           XX                       XX     XX


CTA – Clinical Trial Agreement
SRA – Sponsored Research Agreement
MTA – Material Transfer Agreement
OTHER – Data Use, Non-Disclosure, etc.
    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:

     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               Contract
Project       Investigator         Sponsor
conceived by:

Sponsor        Supports or         Procures service
function:      assists

Control:       Performer defines Sponsor exercises
               details and retains direction or control
               scientific freedom
Sponsor        Maintains           Closely monitors
oversight:     cognizance
  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              Contract
                                            Agreement
Basic Purpose      Provides assistance     Provides assistance   Procure tangible
                   with few restrictions   with substantial      goods and services
                                           involvement
                                           between parties


Solicitation       Application kit or      Request for           Request for
method             guidelines              application (RFA)     proposal or quote


Award instrument   Short – may refer to    Describes             Detailed specs,
                   general conditions      involvement, party    clauses, regulations,
                                           relationships         expected results

Sponsor            Generally no            Substantial           Substantial
involvement and    involvement, little     involvement and       oversight, varying
oversight          oversight of actual     oversight             degrees of
                   work                                          involvement


Rebudgeting        Flexible                Usually flexible      More restrictive
                        Grant          Cooperative           Contract
                                       Agreement
Equipment title   Grantee             Varies             Varies


Performance       Specified           Specified          Specified
period

Patent rights     Generally liberal   May be involved    Specified in contract




Publication       May ask to be       May ask to be      May require prior
                  informed            informed           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    (negotiates for the following sponsor
for the following sponsor types)   and agreement types)
Federal Sponsors – grant,          Corporate (for-profit) sponsors
contract, cooperative agreement    Clinical trials – corporate sponsors
Subcontract with government or     Subcontracts when prime is
non-corporate sponsor as prime     corporate or when both government
Foundations and other non-         & industry funds involved, pre-
profits                            award 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%20Submissi
   on%20Form_111407.doc
   Corporate Contracts Update
How You Can Help Us Help You:

     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         Adam Rifkind
benitah@upenn.edu   rifkind@upenn.edu
215 573 6709        215 898 9990

         Kathryn Steinbugler
         kathryns@upenn.edu
         215 573 9970

				
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