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

NAME AND TITLE CTASRA

(SOM)

SRA (OTHER

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

OUR CURRENT STAFF AND ASSIGNMENTS

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 EfficiencyCompleted 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 ContractsConfidential 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/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 Grant Contract

Project conceived by:

Investigator Sponsor

Sponsor function:

Supports or assists

Procures service

Control: Performer defines details and retains scientific freedom

Sponsor exercises direction or control

Sponsor oversight:

Maintains cognizance

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

RFProposal • 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.

RFQuotationRFApplication

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 (reviews all awards, negotiates for the following sponsor types)

Corporate Contracts Group (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 non-profits

Subcontracts when prime is corporate or when both government & industry funds involved, pre-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%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 benitah@upenn.edu rifkind@upenn.edu215 573 6709 215 898 9990

Kathryn Steinbuglerkathryns@upenn.edu215 573 9970