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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.
  • 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 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;’ Post-Award Compliance (Bob McCann): Facilities and Administrative Costs, Employee Benefit Rates, Effort Reporting, and Financial Compliance Issues; 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. Office of Research Services 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.
    Corporate Contracts Update
  • OUR CURRENT STAFF AND ASSIGNMENTS CTA – Clinical Trial Agreement SRA – Sponsored Research Agreement MTA – Material Transfer Agreement OTHER – Data Use, Non-Disclosure, etc. XX XX     XX Kerry Wilson, Associate Director XX       XX Brian Sharma, Associate Director XX   XX  XX XX Adam Rifkind, Associate Director     XX XX XX Coy Purcell, Associate Director   XX XX XX   Ed Pieters, Associate Director         XX Sheila Atkins, Associate Director   XX       Laurance Guido, Senior Contract Admin. XX   XX XX XX Beth Alioto, Senior Contract Admin.   XX       Matt Merz, MTA Administrator XX   XX XX XX Benita Hall, Contract Administrator XX XX XX XX XX Michelle Buono, Administrative Assistant OTHER MTA SRA (OTHER SCHOOLS) SRA (SOM) CTA NAME AND TITLE
  • 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 ( [email_address] ) 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/index.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 Closely monitors Maintains cognizance Sponsor oversight: Sponsor exercises direction or control P erformer defines details and retains scientific freedom Control: Procures service Supports or assists Sponsor function: Sponsor Investigator Project conceived by: Contract Grant
  • 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
  • RFP roposal
    • 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.
    RFQ uotation RFA pplication
  • More restrictive Usually flexible Flexible Rebudgeting Substantial oversight, varying degrees of involvement Substantial involvement and oversight Generally no involvement, little oversight of actual work Sponsor involvement and oversight Detailed specs, clauses, regulations, expected results Describes involvement, party relationships Short – may refer to general conditions Award instrument Request for proposal or quote Request for application (RFA) Application kit or guidelines Solicitation method Procure tangible goods and services Provides assistance with substantial involvement between parties Provides assistance with few restrictions Basic Purpose Contract Cooperative Agreement Grant
  • Detailed, frequent, may be based on deliverables Frequent reports Annual summary Technical May require prior review and/or approval May ask to be informed May ask to be informed Publication Specified in contract May be involved Generally liberal Patent rights Specified Specified Specified Performance period Varies Varies Grantee Equipment title Contract Cooperative Agreement Grant
  • Groups in ORS responsible for research award reviews and agreement negotiations *Negotiates contracts following awards from Commonwealth of Pennsylvania or City of Philadelphia Other governments except* Subcontracts when prime is corporate or when both government & industry funds involved, pre-award and corporate contracts collaborate Data use agreements, Material transfer agreements Subcontract with government or non-corporate sponsor as prime Foundations and other non-profits Corporate (for-profit) sponsors Clinical trials – corporate sponsors Federal Sponsors – grant, contract, cooperative agreement Corporate Contracts Group (negotiates for the following sponsor and agreement types) Pre-award Services Group (reviews all awards, negotiates for the following sponsor types)
  • 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, [email_address]
    • For the review of material transfer agreements:
    • http://www.upenn.edu/researchservices/materialtransfer/MTA%20Submission%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
    • [email_address] [email_address]
    • 215 573 6709 215 898 9990
    • Kathryn Steinbugler
    • [email_address]
    • 215 573 9970