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8 th Annual Symposium for Research Administrators Working with Industry Joonhyung Cho Director of Business Development, Industry Relations University Development Office Chrissy Kinkade Assistant Director of Business Development, Industry Relations University Development Office Liz Powell Assistant Director of Contracting Office of Sponsored Research November 11, 2020

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  • 8th Annual Symposium for Research

    Administrators

    Working with Industry

    Joonhyung ChoDirector of Business Development, Industry RelationsUniversity Development Office

    Chrissy KinkadeAssistant Director of Business Development, Industry Relations University Development Office

    Liz PowellAssistant Director of ContractingOffice of Sponsored Research

    November 11, 2020

  • 2 0 2 0 S Y M P O S I U M F O R R E S E A R C H A D M I N I S T R AT O R S 2

    Learning Objectives

    • Define roles and responsibilities in working with industry• Describe how working with industry differs from other sponsors• Identify important contract provisions in industry agreements• Outline impact of COVID-19 on industry projects

  • 2 0 2 0 S Y M P O S I U M F O R R E S E A R C H A D M I N I S T R AT O R S 3

    Disclaimer

    • Discussing non-clinical (non-interventional) sponsored research, which includes:• Work that is parallel, or complimentary, to the faculty member’s regular work,

    including federally funded work• A commercial application or extension of previously funded work

    • NOT discussing• Consulting• SBIR/STTR – just follow Federal guidelines

    BEFORE WE START

  • 2 0 2 0 S Y M P O S I U M F O R R E S E A R C H A D M I N I S T R AT O R S

    Roles and Responsibilities

    WORKING WITH INDUSTRY

  • 2 0 2 0 S Y M P O S I U M F O R R E S E A R C H A D M I N I S T R AT O R S 5

    Industry Relations Team• Unit in the University Development

    Office (UDO)• Team of 2 handling industry research

    partnerships• Works with other UNC offices• Leads/supports life cycle of research

    business development: Single point of contact to industry partners Engagement strategy development Communication of corporate priorities

    and interests to university constituents Closely work with faculty and staff on

    industry proposals

    Industry Contracting Team• Unit in the Office of Sponsored

    Research (OSR)• Team of 15 (clinical and non-clinical)• Lead all industry contract

    negotiations for: Sponsored research agreements Data use agreements Non-disclosure agreements Clinical trial agreements Service Agreements

    ROLES AND RESPONSIBILITIES

    Roles of Central Offices – OSR and UDO

  • 2 0 2 0 S Y M P O S I U M F O R R E S E A R C H A D M I N I S T R AT O R S 6

    Role of Principal Investigator (PI)

    • Working with industry sponsor to develop a project• Partnering with departmental research administrators or business officers

    to develop the budget and administrative documents• Working with their scientific liaisons at the industry sponsor• Divulging accurate compliance disclosures• Reviewing intellectual property, commercialization and export control

    submissions in RAMSeS IPF• Providing input on the research agreement where necessary

    ROLES AND RESPONSIBILITIES

  • 2 0 2 0 S Y M P O S I U M F O R R E S E A R C H A D M I N I S T R AT O R S

    Key Differences

    WORKING WITH INDUSTRY

  • 2 0 2 0 S Y M P O S I U M F O R R E S E A R C H A D M I N I S T R AT O R S 8

    Communication

    • Relationship management• University Development Office (UDO) – Industry Relations• Unit development offices

    • Managing expectations

    KEY DIFFERENCES TO CONSIDER

  • 2 0 2 0 S Y M P O S I U M F O R R E S E A R C H A D M I N I S T R AT O R S 9

    Funding Overlap

    • What types of other funding does the PI have?• Federal government• State and local government• Foreign governments• Industry (domestic/foreign)• Non-profit organizations (domestic/foreign)• Donors

    KEY DIFFERENCES TO CONSIDER

  • 2 0 2 0 S Y M P O S I U M F O R R E S E A R C H A D M I N I S T R AT O R S 10

    Intellectual Property (IP) and Data Ownership

    • Intellectual Property• Is there background IP?• Does the PI have invention disclosures filed with the Office of Technology

    Commercialization (OTC)?• Is IP expected to be generated during the course of performance?

    • Data• Are we getting data from the industry partner?• How will the data be managed?• How will data be used in the future?• Who will own the data generated during the project?

    KEY DIFFERENCES TO CONSIDER

  • 2 0 2 0 S Y M P O S I U M F O R R E S E A R C H A D M I N I S T R AT O R S 11

    Endorsements/Use of Names

    • Is UNC receiving and/or testing an industry product?• Is the industry partner asking the PI to endorse a product?• Is the industry partner asking to use our logos or the name of PI?

    KEY DIFFERENCES TO CONSIDER

  • 2 0 2 0 S Y M P O S I U M F O R R E S E A R C H A D M I N I S T R AT O R S 12

    The Proposal

    • Not your “traditional” proposal• Usually relatively short and contains less detail compared to grant

    proposals• Unless specified in an RFP, there are rarely guidelines and formatting

    requirements

    KEY DIFFERENCES TO CONSIDER

  • 2 0 2 0 S Y M P O S I U M F O R R E S E A R C H A D M I N I S T R AT O R S 13

    Budget and Billing

    • Budget format• Detailed v. total

    • F&A (indirect rate/overhead) used• 55.5% v. 36% v. 28%

    • Billing mechanism• Fixed price v. cost reimbursable

    KEY DIFFERENCES TO CONSIDER

  • 2 0 2 0 S Y M P O S I U M F O R R E S E A R C H A D M I N I S T R AT O R S 14

    Gifts

    • Comes with:• “No strings attached” - No quid pro quo• No deliverables/milestones/restrictions• No F&A applicable

    • Most flexible/least restrictive• May be more efficient• University Development Office processes

    • Industry Relations• Unit Foundations (e.g. Health Foundation, Pharmacy Foundation and more)

    KEY DIFFERENCES TO CONSIDER

  • 2 0 2 0 S Y M P O S I U M F O R R E S E A R C H A D M I N I S T R AT O R S 15

    Gifts, cont.

    • General purpose may be specified (donor intent)• But, a “restricted gift” from a company may constitute a “grant”

    • Is it a sponsored research agreement disguised as a gift?• Industry partner wants to give a PI a gift, but wants a report on the research• Research gift• Certain gifts may trigger COI review• https://research.unc.edu/2017/05/12/gift-vs-sponsored-project/

    • There can be both sponsored research funding and a gift• Ex: sponsored research agreement for a specific project and a gift for a

    professorship to be decided by the dean

    KEY DIFFERENCES TO CONSIDER

  • 2 0 2 0 S Y M P O S I U M F O R R E S E A R C H A D M I N I S T R AT O R S

    Important Contract Provisions

    WORKING WITH INDUSTRY

  • 2 0 2 0 S Y M P O S I U M F O R R E S E A R C H A D M I N I S T R AT O R S 17

    Important Provisions in an Agreement

    • Data and Intellectual property• Deciding who owns what

    • Publication• University must reserve the right to publish but can allow for a review period

    • Confidentiality• Indemnification and warranties• Scope of work

    • Detailed description of the project

    CONTRACT PROVISIONS

  • 2 0 2 0 S Y M P O S I U M F O R R E S E A R C H A D M I N I S T R AT O R S

    COVID-19 Impacts

    WORKING WITH INDUSTRY

  • 2 0 2 0 S Y M P O S I U M F O R R E S E A R C H A D M I N I S T R AT O R S 19

    Impacts on Research

    • Updates can be found here: https://research.unc.edu/covid-19/• If research can be done remotely, it should be conducted remotely• Reduced capacity on campus as determined by research deans of individual schools

    and the College of Arts and Sciences Specific guidelines for working on campus - https://research.unc.edu/covid-19/resuming/all/

    • Human subjects research specific guidelines• https://research.unc.edu/covid-19/resuming/human-subjects/

    • Research support offices continue to be open and operating remotely to provide full support to the research enterprise

    COVID-19 IMPACTS

    https://research.unc.edu/covid-19/https://research.unc.edu/covid-19/resuming/all/https://research.unc.edu/covid-19/resuming/human-subjects/

  • 2 0 2 0 S Y M P O S I U M F O R R E S E A R C H A D M I N I S T R AT O R S 20

    Impacts on Research, cont.

    • Hiring - https://hr.unc.edu/covid-19/hr-action-pause/• University system has temporarily suspended all non-essential HR actions including

    salary adjustments, position actions (including creating new positions or modifications to existing positions), and recruitment activities (postings, hires, etc.). Exceptions may be granted

    • Grant-funded actions – can move forward if fully funded by external funding For these actions, please include in the comments that the position is fully grant funded. Other type of actions, such as reclassifications and

    salary increase requests, are subject to the pause on non-essential HR actions. Also, partially grant funded actions of all types must be submitted through the process outlined at go.unc.edu/hractions for Chancellor/Chancellor’s designee review and approval.

    COVID-19 IMPACTS

    https://hr.unc.edu/covid-19/hr-action-pause/

  • 2 0 2 0 S Y M P O S I U M F O R R E S E A R C H A D M I N I S T R AT O R S 21

    Confidentiality and Cybersecurity in Remote Work

    • Confidentiality• Maintaining confidentiality of all confidential UNC and third-party information Need to know Care in use of personal devices, accounts Importance of non-disclosure agreements (NDA) or confidentiality agreements (CDA)

    • Consideration in public disclosure (e.g., social media and webinar)• Cybersecurity

    • https://its.unc.edu/workremote/• Virtual Private Network (VPN) – access to remote data• Beware of phishing attempts• Security with data sharing/clouds

    COVID-19 IMPACTS

    https://its.unc.edu/workremote/

  • 2 0 2 0 S Y M P O S I U M F O R R E S E A R C H A D M I N I S T R AT O R S 22

    Changes to Project Timelines

    • Need to formally document any changes in a contract amendment• No cost extensions – lengthens the period of performance beyond the original

    expiration date in order to finish a project without adding to original award amount• Supplemental funding – additional funding through original partnership• Budget/deliverable/milestone revisions – may offer flexibility for funding and

    project as work unfolds

    COVID-19 IMPACTS

  • 2 0 2 0 S Y M P O S I U M F O R R E S E A R C H A D M I N I S T R AT O R S

    Recap – Key Takeaways

    WORKING WITH INDUSTRY

  • 2 0 2 0 S Y M P O S I U M F O R R E S E A R C H A D M I N I S T R AT O R S 24

    Key Takeaways

    • University resources on working with Industry• OSR leads all legal negotiations and is the authorized signatory• Industry Relations can assist with all things related to industry or get you to the

    right people

    • Multiple offices engage in research partnership with industry• Work with Joon/Chrissy (UDO) and Liz (OSR) to structure the engagement

    properly or to talk through COVID-19 impacts on existing projects

    • Choose the most appropriate F&A rate (usually 55.5%)• A gift can be part of the sponsored research discussion

    RECAP

  • w w w. s y m p o s i u m .w e b . u n c . e d u | O S R _ S y m p o s i u m @ u n c . e d u

    CONTACT US

    Joonhyung [email protected] | https://industry.unc.edu/

    Chrissy [email protected]| https://industry.unc.edu/

    Liz [email protected] |

    https://research.unc.edu/sponsored-research/

    http://www.symposium.web.unc.edu/mailto:[email protected]://industry.unc.edu/https://industry.unc.edu/https://research.unc.edu/sponsored-research/

  • 2 0 2 0 S Y M P O S I U M F O R R E S E A R C H A D M I N I S T R AT O R S

    Slide Number 1Learning ObjectivesDisclaimerRoles and ResponsibilitiesRoles of Central Offices – OSR and UDORole of Principal Investigator (PI)Key DifferencesCommunicationFunding OverlapIntellectual Property (IP) and Data OwnershipEndorsements/Use of NamesThe ProposalBudget and BillingGiftsGifts, cont.Important Contract ProvisionsImportant Provisions in an AgreementCOVID-19 ImpactsImpacts on ResearchImpacts on Research, cont.Confidentiality and Cybersecurity in Remote WorkChanges to Project TimelinesRecap – Key TakeawaysKey TakeawaysSlide Number 25Slide Number 26