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 – – – – – Invoices M&S Expenses as backup to invoices Expenses by Milestone Technical Timeline • Equipment and Travel • Subcontracting Plan and Strategic Work Plan Team Project: Goals and Institutions • Goals: to develop animal models, immunoassays, correlates of protection and vaccine candidates for Francisella tularensis • NIAID- funding agency – Ross Kelley (Contract Officer) - contract and financial oversight – Vicki Pierson PhD (Project Officer) - scientific and technical oversight – Marlene Hammer (Project Manager) - business oversight • 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 • 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 LBERI • UNMHSC has prime contract with NIAID • LBERI has subcontract with UNMHSC • UNMHSC prime contract is included in subcontract with LBERI NIAID UNMHSC LBERI UNMHSC communicates with NIAID and LBERI. 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 • • • • • • 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 [email protected] and copy to [email protected] LBERI Invoice “Negotiated”: funding from date of award to 9/29/2010 “Actual”: funding from date of award to 1/31/2008 LBERI Invoice: Direct Labor Key Points: Invoices • • • • • • • • 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#2- must be listed on the invoice for LBERI 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”= LBERI Subcontract M&S Expense: Detailed Backup Documentation in Excel PDF of Vendor Invoice 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 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 Managing funds and scientific productivity Expenses by Milestones: Summary 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- don’t add columns, don’t add lines, don’t rearrange columns, don’t rearrange lines- 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 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 Connie Jefferson (505-272-4123) 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 LBERI • Need subcontracting plan from LBERI, and UTSA • 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!