Tularemia Vaccine
Development Contract
Administration and
Financial Management
C. Rick Lyons, MD PhD
Barbara Griffith, MS
Mindy Tyson, MPA
Presentation Overview
• Team Project: Goals and Institutions
• NIAID Contract, Subcontracts, Communication
• Administration and Financial Management
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Invoices
M&S Expenses as backup to invoices
Expenses by Milestone
Technical
Timeline
• Equipment and Travel
• Strategic Work Plan
Team Project: Goals and
Institutions
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Goals: to develop animal models, immunoassays, correlates of
protection and vaccine candidates for Francisella tularensis
NIAID- funding agency:
(National Institute of Allergy and Infectious Disease)
– Ross Kelley (Contract Officer) - contract and financial oversight
– Vicki Pierson PhD (Project Officer) - scientific and technical oversight
– Marlene Hammer (Project Manager) - business oversight
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UNMHSC- prime contractor
– Rick Lyons, MD PhD (Principal Investigator) - Overall project productivity as
well as directly responsible for small animal model, immunoassays, correlates of
protection
– Barbara Griffith, MS (Project Director) - fiscal and scientific management
– Mindy Tyson, MPA (Project Manager) - fiscal reports
– Sheri Fisher (Fiscal Monitor) - Invoices
– Jenni Kain/Mary Beth Howe (Contracts and Grants
Administrators) -subcontracts
Subcontracting Institutions
• Lovelace Biomedical and Environmental Research
Institute (LBERI)
– Bob Sherwood, PhD (subcontracting PI) - aerosol delivery and
non-human primate model
• Arizona State University
– Stephen Johnston PhD and Kathryn Sykes PhD (subcontracting
PI’s) - transcriptome and proteinomic vaccine approaches
• Cerus Corporation- California
– Justin Skoble PhD (subcontracting PI) - KBMA vaccine approach
• University of Texas San Antonio
– Karl Klose PhD (subcontracting PI) - bacterial genetics vaccine
approach and genetic understanding of bacterial pathogen
NIAID Contract, Subcontracts,
Communication
NIAID
UNMHSC
LBERI
ASU
Cerus
UTSA
NIAID Contract, Subcontracts,
Communication with Cerus
• UNMHSC has prime contract with NIAID
• Cerus has subcontract with UNMHSC
• UNMHSC prime contract is included in
subcontract with Cerus
NIAID
UNMHSC
Cerus
UNMHSC communicates with NIAID and Cerus. UNMHSC provides consolidated
reports to NIAID. NIAID and subcontractors do not directly communicate with each other.
NIAID Contracting Officer
The Contracting Officer is the only person that
has the authority to:
- direct or negotiate any changes to the Statement
of Work in prime contract
- modify or extend the period of performance
- change the delivery schedule
- authorize reimbursement of costs incurred by the
Contractor during performance
- change the terms and conditions of prime
contract.
NIAID Project Officer
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The Project Officer is responsible for:
Monitoring technical progress
Recommending changes in requirements to the
CO
Interpreting technical performance requirements
Performing required inspection and acceptances
Assisting in the resolution of technical problems
encountered during performance
Reviewing invoices before Contract Officer
authorizes payment
Contract Obligations and
Limitations
The mutual obligations of the Government
and the University of New Mexico Health
Sciences Center are established by, and
limited to, the written stipulations in the
contract document. Unless specifically
authorized by the Contracting Officer, the
University of New Mexico Health Sciences
Center shall not assume any obligations or
take any action not specifically required or
authorized by the contract.
Limitation of Funds
• This clause is found in this cost-reimbursement,
incrementally funded contract. This clause
requires a Contractor to notify the Contract
Specialist/Contracting Officer, in writing,
whenever you have reason to believe that the
costs you expect to incur within 60 days will
exceed 75% of the total amount currently
allotted to the contract. Please be aware that to
exceed the total amount of funding currently
available under the contract is to do so at your
own risk without this notification.
Contract Changes
Any changes in the
terms or conditions of
the contract, including
the Work Statement,
contract cost, or
delivery schedule
must be done by
written modification.
Administration and Financial
Management
Monthly Reports (Exhibit E in subcontract)- due 7th of month
– Invoices
– M&S Expense detail as backup to invoices
– Expenses by Milestone
– Technical
– Project Timeline in MS Project
Other Reports (Exhibit E in subcontract)
– Subcontracting Report (semi-annually)- due 4/15 &10/15
– Semi-Annual Progress Report- due 4/7/06
– Milestone Report- after completion of milestone
– Final Report- due 20 days before agreement expires
Submission dates are firm for all reports and invoices
Submit reports electronically to Bgriffit@salud.unm.edu and copy to
Mtyson@salud.unm.edu
Cerus Invoice
“Negotiated”: funding from
date
of award to 9/29/2010
“Actual”: funding from date of
award to 1/31/2008
Cerus Invoice Spreadsheet
Cerus Invoice:
Direct Labor
Cerus Direct Labor Link
Key Points: Invoices
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Cost reimbursement Contract
– Subcontractor pays vendor, subcontractor invoices UNMHSC, UNMHSC pays
subcontractor, UNMHSC invoices NIAID, NIAID pays UNMHSC
– UNMHSC or NIAID Contract Officer can place invoice in suspense if all
documentation does not match or is not provided.
COA#4-must be listed on the invoice for Cerus
Expense categories= labor, fringe, M&S, animal (purchase and maintenance),
consultant, computer service, G&A (indirects)
Discuss “negotiated” vs “actual” on the invoices
Discuss the purpose of the variance columns
Backup documentation to labor and fringe
– Names, pay rate, percentage effort, total cost/person for the month
Backup documentation to animal expenses
– Species, number of animals, cost per animal, total cost of animals, animal
maintenance
Retain format of the invoice template - UNM wants the cells to match original
locations so that 4 subcontractor sheets roll into a consolidated invoice seamlessly.
Key Points:
Invoices- Accountable Property
• COA#’s required before ordering equipment, even when
equipment is on approved budget
• Accountable Government Property definition= >$1000
cost and life expectancy of 2 yrs (PC Article B.3.a.9; SC
Article 3.A.8)
• Accountable Property must be listed on Attachment 7 in
Prime contract; Government Property Schedule 1A and
in Exhibit B of subcontract.
• Procurement of certain other sensitive items at any cost
(ex: general office equipment, calculators, photography,
computers (PC Attachment 5) requires COA#.
• “PC”= UNM Prime Contract
• “SC”= Cerus Subcontract
M&S Expense: Detailed Backup
Documentation in Excel
UNM TVDC
PDF of
Vendor
Invoice
PDF Invoice Link
Key Points: M&S detail backup
documentation
• M&S
– M&S expense total on invoice must match detailed
backup documentation to the M&S expenses
– Backup detail is due whenever sum of M&S for all 5
institutions exceeds $1000
– Strongly prefer electronic backup to M&S
– Backup will be submitted to Contract Officer
– Excel summary and PDF of supplier/vendor invoices
– Excel: vendor, items, cost
Animal Expense: Detailed Backup
Documentation in Excel
Form Fields that MUST be included in Animal Expenses Invoice:
Species, cost per animal, number of animals, total cost of animals
Animal Expense Worksheet Link
Unallowable Unless
Authorized
Items unallowable unless authorized in writing by the
Contracting Officer or otherwise provided in the
contract:
Real property
Alteration of Facilities
Furniture or Office equipment
General Scientific Meeting Travel
Foreign Travel
Consultant Costs
Subcontracts
Patient Care Costs
Unallowable Expenses (continued)
• Review articles/sections of contract :
– definition of accountable property (PC Article B.3.a.9);
– Procurement of certain sensitive items at any cost (PC
Attachment 5)
• Can’t purchase, lease or rent
– general purpose ADP equipment (software, calculators, hole
punches etc)
– Photographic equipment
– Training aids and devices
– Furniture
– Household and commercial furnishings and appliances
– Office machines and visible record equipment
– Musical instruments, photographs, and home-type radios
– Recreational and athletic equipment
• Need COA# to purchase any of the above items
Expenses by Milestone: showing
monthly reporting over 1 year
Cerus: Expenses by Milestone
Managing funds and scientific productivity
Expenses by Milestones: Summary
Expenses by Milestone Link
Key Points: Expenses by Milestone
• Expenses by milestone total must match the invoice
total, unless capital equipment is expensed on the
invoice
• % work completed for each milestone on “Expense by
Milestone form” must match % work completed for each
milestone on the Technical report
• Explanation of variances between % funds expended
and % work completed.
• RETAIN format of the “Expense by Milestone” excel
templates- yellow cells are the only editable regions, all
other cells are locked - UNM will be copy /pasting and
want the cells to match original locations so that 4
subcontractor sheets roll into a consolidated summary
worksheet seamlessly.
Technical
Report
Technical Report Link
Key Points: Technical Report
• Match % work completed on Technical
Report to % work completed on Expense
by Milestone report in excel
• Scientists will prepare
• Submit technical report along with invoice,
M&S backup detail documentation, and
expense by milestone report in excel
Project Timeline Report
Key Points: Project Timeline Report
• Report monthly
• Highlight changes in timeline, changes in
endpoints, changes in “go/no go” decision
points
• MS Project timeline report- review overall
project and their components
• UNM will enter into MS Project file for
TVDC
Travel
Submitted by Traveler to
UNM for reimbursement;
Send to Kay Jantz
(505-272-2288)
Travel Reimbursement Link
Key Points: Travel
• Travel budget resides with UNMHSC
• UNMHSC Travel policy applies to
subcontractor’s travel
• Review travel submission form and procedure
for travel
• NIAID approval requirements:
– COA# required for travel to general scientific
meetings
– 3 month advance written warning prior to domestic
travel, even if travel has already been approved in the
contract
Other Documents
Needed from Cerus
• Need strategic work plan from each
Subcontractor; UNM will provide a draft to
each Subcontractor.
Team Effort
• Success of TVD Contract depends on
cooperation between all 5 participating
institutions
• Work together as a team
• Meet NIAID contractual requirements
• Always welcome feedback and better
ideas for streamlining and decreasing
effort
Thank you!