11 THIS CO/-ITRACT IS A RATED OROER

AWARD/CONTRACT► !RATING

UM>ER OPAS 115 CFR 700)

RHS0100201600029C

09/01 / 2016

cooel

ASPR-BAROA
200 Independence Ave.,
Room 640- G
Washington DC 20201

1

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8. Ot:l.11/l,RY

I[] Oll1ER IS# below)

QF090RIGIN

MODERNA THERAPEUTICS, INC . 14 92235
MODERNA THERAPEUTICS, INC.
200
200 TECHNOLOGY SQUARECAMBRI DGE MA 021393578

9. otSCOUKT FOR PROMPT PAYMENT

10 SUOMIT INVOICES(4 a,plts Ut'MSS 01helWIS8 spaclled)

TO THEMORESS StlOV~ IN

IFACIUTYCOOE

1492235

11. SHIP TOIMARl< FOR

COOE I

12. PAYMEHT WI.L BE MADE SY

HRS

200 Independence Avenue, SW
Was hington DC 20201

15A. ITEMNO

CODE

PSC

1 ◄ ACCOUNTING ANO APPROPRIATION OATA

13. AUTHORITY FOR USING OTHER THAN FULL ANO OPEN COMPETITION
)

►

ITEM

PSC
Program Support Center
5600 Fishers Lane
Room 17-21
Rockville MD 20852

HHS

O ,o u.s.c. 2304 1e> 1

ASPR- BARDAOl!AS?R-BARDA
33C Independence Ave, SW, Rm G644
Washington DC 20201

7 NAME ANO ADC>RESS OF CONTRACTOR (No•• SIIN(. Q!y, Coun:,Y, stsr. _, ZJP Code)

COOE

2

See Schedule

6 ADMINISTERED BY (lfeltterlhan Item 51

ASPR- BARDA

I

13. EFFECTIVE DATE rs REQUISITION/PURCHASE REQUEST/PROJECT NO.

2. CONTRACT (Proc. tn,t. ld9nt) NO
5. ISSUEOBYIPAGE OF PAGES[Jo u S.C. 253 tel I

2016.199SCHF . 25210

)

150
15C
OUANTITY UNIT

158 SUPPUESISERVICES

15E- UNIT PRICE

15F.AMOUNT::ontinued
15G TOTAL AMOUNT OF CONTRACT►I$8,205.759.00

1&.. TABLE OF CONTEHTS

(X)

sec.

PAGE(SIOfSCRIPTION

PARTl , THESCHEOUI.E

XASOUCITATIONICONTRACT F~XX8SUPPLIES OR SERVICES ANO PRICES/COSTSCOESCRlPTlON/SPECSJWORK STATEMENTX

D

PACKAGING ANO MARKINGAE

INSPECTION ANO ACCEPTANCE

XF

DELIVERIES OR PERFORMANr"

I\.

G

X

H

fXI

SEC

OESCIWTION

PAGE:(S)PART 1-COHlRACT ~ S

XICOHTRACT CLAUSESPAAT Ill- UST OF OOCUMEHTS. EXHIBITS ANO OTHER ATTACH

X
X.

LIST OF ATTACHMENTS
J
PART 11/-REPRESEHTATIONSANO INSTRUCTIONSI(

REPRESENTATIONS. CERTIFICATIONS ANO
0Tl(ER STATEMEMTS OF OFfERORSCONTRACT ADM11'11STRATION DATALINSTRS . CONOS ANO NOTICES TO OFFERORSSPECIAL CONTRACT REQUIREMENTSM

EVAUJAT101f FACTORS FOR AWAAD

COKTRACfftG OfflCER WIU.. CONPI..ETE ITEM 17 (SEALED-SID OR NEGOTIATED PROCUltEMEN OR 11 (Sl!AL.ED-lljD PROCUIQ!MAS APPUCABLE
17. □CONTRACTOR' S NEGOT IATEO AGREEMENT (Con/raclorIS ,eq,.rire(1 /0 alg11 this18. SEALE0-81> AWARD (Ccamnoc:tor is not ,..,...., lo ,ig,I this documenl.) Your bid on
doe1JmetJl end191um _ _ __ c:ope:,Ao~ollce-JContraclor....-eo~Numlxorl\mlah and deli\..,- Ill ~em, ar re,farm an Ifie aervice1 aellonn ar othelwlM lclerllled
ebaVe and on a n y ~ - IOf h ccnaldera:lc,r, _,..,_ The rig1la..,cbl4g:atior'l&ol the ~IO.,_ ccnnct at-.l be IIJl)jecttoanoll(l\'elT,ecl by lhe ~dOcunents: (a) lhll -.:I/Contract. (b) Iha sok:llelb\ f .,,., rd {c) sut:11 ~rwp'llWt'UtlOnS, ~ Ind ~... . ~ 0( " ' " ' " ' " lted I>)'...,.,..,,ce heren A/!ocltments an, •otea /'le~.

1QA. NAME ANO TITLE OF SIGNER (Type ar imnl)

hdudng fhe addi!lotls ar ~ made by )CU which addi'.lonl ar c:i.,,gao .n Ml tent,
in M l -. 11 """"V aa:epc-, as to ll>e ...,,. ltSted at,c,,e and on any aJf-cn.etion

This awn oonarnmates tl'e c:ontrac.t wti<h eo111i.ts of lh9 ~- . (e)"8G_,.,-..,,r._...,,,.-,c1 'fO'Sbid end (bl lhll • No utr«a,nnc:ti.,al docu'nfflC. ,_..., (Block 1e Should be ched<ed cnly whena
NAME OFcortradGOfF

FRANCINE L. HEMPHILL
19B NAME OF CONTRACTOR

19C. DATE SIGNEDBY(Si nalvre of
MITttORIZEO RlR l.0CAI. ~Prwl0us edruon is NOT usable

STANDARD

21 (Rev. S/!011).,,._litGSA- FAR (ct CFR) 53.2 1<(1)CONTINUATION SHEETPAGEREFERENCE NO. OF DOCUMENT BEING CONTINUED

HHS0100201600029C

OF

2

2

NAME OF OFFEROR OR CONTRACTOR

MODERNA THERAPEUTICS,

INC . 1492235

ITEM NO.

SUPPLIES/SERVICES

(A)

(B)

QUANTITY UNIT(C)Tax I D Number : 27- 0226313
DUNS Number :069723520
MODERNA T!iERAPEUTI CS , INC :~Oll.4}

Base :l>)tll)IOllCt)Obligate d Amount : $8 , 205 , 759 . 00
Requisit-1.on No: 05181373 , 0S183350

AMOUNT

(E)

(F)

'I

;tl)(4)l

ID)

UNIT PRICEI

B, 20 5 , 759 . 0 0

I

Amount : $8 , 000 , 000 . 00
Amount : $205 , 759 . 00
11Jlf4)2W4)lll)tcl

AUTflORIZED .OR LOCAL REPRCOPTIONAL FORM 3l6 (4-66)
Sponsored by GSA

fAR (48 CfR) 63-l 10

PART I -THE SCHEDULESECTION B - SUPPLIES OR SERVICES AND PRICES/COSTSARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES
The objective of this contract is Jbfi4l

J)(4l

I

r

..___________ !See the Statement of Work, Attachment# I .
~

bJ(4)

_____ ribe GO/NO GO Contract Mjlestones and Decision Gates will

,___

__,

constitute the basis for the Government' s decision, at its sole disctetion, to exercise
any follow-on option segment(s).
lfl{,1)______________________ I It is possible

l>X4J
..__

___,

that more than one independent, non-severable discrete work segment(requirement). may be awarded at one time and that individual CLINs may overlap
and/or proceed concunentJy.

ARTICLE B.2. ESTIMATED COST

1. The total estimated cost of this contract is $8,000,000.
2 ib)(-4)
'

4.

5.

6.

7. Consistent with FAR 52.2 I6-8, Fixed-Fee (Jun 201 1), any fixed fees payablein the option periods may be invoiced, and will be paid, in an amountproportionate to the percentage of total estimated costs for each applicable
option period that the Contractor is estimated to have incurred at the time atwhich an invoice is submitted. Amounts paid under this provision will not
exceed the total fixed fee identified in A11icle B.3 for each option period, andthe Contracting Officer may witWJold a portion of the total fixed fee for eacb
option period in an amount not to exceed 15 percent of the fixed fee or$100,000, whichever is l ess, consistentwith PAR 52.216-8, Fixed Fee (Jun
2011).
BASE PERIOD
Estimated
Period of
Perfortnance

CLIN

Estimated
USG Cost

Supplies/Services

Total
Estimated
Cost

Fee/profit~)(4)

9/1/2016
Through
10/31/2018

0001

lf!MI

$8,000,000$8,000,000

TOTAL
I

ARTICLE B. 3. OPTION PRICES
a. Unless the government exercises its option purs uaut lo tJ1e option clausecontained in ARTICLE 12, tbe contract consists onJy of the Base Period Worksegment (CLIN 0001) specified in the Statement of Work as defined in
Attachment 1, for the price set forth in ARTICLE B.2 of the contract.
b. Pursuant to FAR Clause 52.217-9 (Option to Extend the Term of the Contract),
the Government may, by unilateral contract modification, require the Contractor
to perform the Option Work Segments specified in the Statement of Work as
defined in Attachment 1 of this contract. If the Government decides to exercise
an option(s), the Government will provide the Contractor a preliminary written
notice of its intent as referenced in the clause. Specific info1mation regardjng
the time frame for this notice is set forth in the OPTION CLAUSE Article in
SECTION G of this contract. Tbe amount obligated to the contract and the total
estimated cost will be increased as set forth below:

OPTIONS
Option 1 (CLIN 0002) through Option 4 (CUN 0005)

CLIN

OptionPeriodEstimated
Peliod of
PerformancelD)(4)

0002rb)f4)

0001

Supplies/Services

Estimated
USG Cost

Fee/Profit

Total
Estimated
Costage OHillllhekl pursuanl to exempuon

0)(4!

f the Freedom of Information Act

11 ) Light Refreshment and M eal Expenditures - Requests to use contract funds toprovide light refreshments and/or meals to either federal or nonfederal employees
must be submitted to the Contracting Officer's Representative (COR), with a copy
to the Contracting Officer, at least six (6) weeks in advance of the event and are
subject to "HHS Policy on Promoting Efficient Spending: Use of Appropriate
Funding for Conferences and Meetings, Food and Promotional Items and Printing
and Publications." The request shall contain the following infmmation: (a) name,date, and location o f the event at which the light refreshments and/or m eals will
be provided ; (b) a brief description of the purpose of the event ; (c) a cost
breakdown of the estimated light refreshments and/or meals costs; (d) the numberof nonfederal and federal attendees 1·eceiving light refreshments and/or meals; and(e) confirmation of w hether the event w ill be held at a government facility.

b. Travel Costs
I . Total expenditures for travel (transportation1 lodging, subsistence, and incidental
expen ses) inc urred in direct performance of this contract during the base segment(CUN 0001) shall not exceed ~ )(4}
!without the prior written approval of theContracting Officer. The Contractor shall notify the Contracting Officer inw riting when travel expenditmes have exceeded~~>jof the basesegment travel expenses. Cost must be consistent with Federal Acquisition
Regulations (FAR) 52.247-63 - Preference for U.S. Air F lag carriers. Costs
incurred for lodging, meals, and inc idental expenses shall be consideredreasonable and allowable to the extent that they do not exceed on a daily basis the
per diem rates set forth in the Federal Travel Regulation (FTR).
2. Subject to the annual dollar limitation specified under B.4.b.1. ab ove, theContactor shall invoice and be reimbursed for all travel costs in accordance with
Federal Acquisition Regulation (FAR) 3 1.2 - Contracts with Commercial
Organizations. Subsection 3 1.205-46, Trave] Costs.
3. If foreign travel is necessary, a Contracting Officet Authorization (COA) will be
required. Expenditures for foreign travel (transporta tion, lodging, subsistence, andincidental expenses) incurred in direct performance of this contract sh all not
exceed the amount specified in each approved COA, without the prior written
approval of the Contracting Officer.
Requests for foreign travel must be submitted at least four weeks in advance andshall contain the following:(a) meeting(s) and place(s) to be visited, with costs and dates;(b) name(s) and title(s) of Contractor pe.rsonnel to travel and theirfunctions in the contract project;(c) contract purposes to be served by the travel;(d) how travel of Contractor personnel will benefit and contribute toaccomplishing the contract project, or will otherwise justify the
expenditure of ASPR contract funds;(e) how such advantages justify the costs for travel and absence from the
project of more than one person if such are suggested; and(f) what additional functions may be performed by the travelers toaccomplish other purposes of the contract and thus further benefit the
project.
ARTICLE B.5. ADVANCE UNDERSTANDINGSa.

Person-in-Plant

With seven (7) days' advance notice to the Contractor in writing from theContracting Officer, the Government may place a person-in-plant in theContractor's facility or performance sites (to include subcontracts) for the sole
purpose of monitoring activities directly related to performance of this contract,
who shall be subject to the Contractor's policies and procedures regarding
security and facility access at all times while in the Contractor's facility. As
determined by federal law, no Government representative shall publish, divulge,
disclose, or make known in any manner, or to any extent not authorized by law,
any information coming to him in the course of employment or official duties,
while stationed in a contractor plant.
b.

Security

No Security Plan is required at this point for this effort.
c.

Subcontracts

Prior written consent from the Contracting Officer in the form of Contracting
Officer Authorization (COA) is required for any subcontract that:••

Is of the cost-reimbursement type; or
Is Fixed-Price and exceeds $ 150,000 or 5% of the total estimated costof the Contract, whichever value is greater.

The Contracting Officer shall request appropriate supporting documentation inorder to review and determine authorization, pursuant with FAR Clause 52.244-2,
Subcontracts. After receiving written consent of the subcontract by theContracting Officer, the Contractor shall provide a copy of the signed, executed
subcontract and consulting agreement to the Contracting Officer.
Note: Consulting services are treated as subcontracts and subject to the 'consent
to subcontract' provisions set forth in this Article.

The Contractor is not required to obtain consent to enter into agreements with
{ll~)

d.

Confidential Treatment of Sensitive Information

The Contractor shall guarantee strict confidentiality of any information/data of asensit ive nature that is provided to the Contractor by the Government during thepe1·fonnance of the contract. The Government has determined that the
information/data that the Contractor will be provided during the performance of
tbe contract is of a sensitive nature.
Disclosw-e of infomrntion/data that is provided by the Government and sensitivein nature, in whole or in pa.rt, by the Conh·actor can only be made after theContractor receives prior wtitten approval from the Contracting Officer, except
that, without prior approval, the Contractor may disclose such information to
subcontractors, consultants, and affiliates performing work under this contract,with restrictions on further disclosw-e. Whenever the Contractor is uncertain withregard to the proper handling of information/data under the contract, theContractor shall obtain a written determination from the Contracting Officer (seealso HHSAR clause 352.224-71).
Notwithstanding the foregoing, such infonnatiou/data shall not be deemed of asensitive nature with respect to tbe Contractor for purposes of this contract if suchinfonnation/data: (a) was already known to the Contractor at or prior to the timeof its disclosw-e to the Contractor; (b) was generally available or known, or wasotherwise part of tbe public domain. at the time of its disclosure to the Contractor;(c) became generally available or known, or otherwise became part of the publicdomain, after its disclosure to, or, with respect to the infom1atio n/data by, theContractor through no fault of the Contractor; (d) was disclosed to the Contractor,
other than under an obligation of confidentiality or non-use, by a third patty who
had no obligation to the Government that controls such information/data not todisclose such information/data to others; or (e) was independently discovered ordeveloped by the Contractor, as evidenced by its written records, without tbe useof information/data belonging to the Government.
Contractor may disclose information/data of a sensitive nature provided by tbe
Government to the extent that such disclosure is: (a) made in response to a valid
order of a cowt of competent jw"iscliction or other supra-national, federal,national, regiona~ state, provincial or local governmental or regulatory body ofcompetent jurisdiction; provided, however, that the Contractor shall first havegiven notice to the Government and give the Government a reasonable
opportunity to quash such order and to obtain -a protective order requiring that theinfonnation/data of a sensitive nature that is the subject of such order be held in
confidence by such court or agency or, if disclosed, be used only for the purposes
for which the order was issued ; and provided ftu·ther that if a discJosw·e order is
not quashed or a protective order is not obtained, the information/ data disclosed in
response to such court or govemmental order shall be limited to that information
which is legaJly required to be disclosed in response to such court or
governmental order; (b) otherwise required by 1aw, in the opinion of legal counsel
to the Contractor as expressed in an opinion Jetter in form and substancereasonably satisfactory to the Government, which shall be provided to theGovernment at least two (2) business days prior to the Contractor's disclosure of
the information/data; or (c) made by the Contractor to the regulator y authorities as
required in connection with any filing, application or request for regulatory
approval; provided, however, that reasonable measures shall be taken to assure
confidential treatment of such information/data.
e.

Sharing of contract deliverables within United States Government (USG)
In an effon to build a robust medicaJ countermeasure pipe1ine through increased
collaboration, BARDA may share technical deliverables set forth in Article F.2
with Government entities responsible for Medical Countermeasure
Development. In accordance with recommendatio ns from the Public Health
Emergency M edical Counte1measure Enterprise R eview, agreements establishedin the Integrated Portfolio's Portfolio Advisory Committee (PAC) Charter,
Technology Transfer Agreements (TI A) between BARDA and the Defense
Threat Reduction Agency and the National Institute of Allergies and Infec tious
Diseases (NJAID), the Government may share technical deliverables set forth in
Article F.2 with colleagues within the Integrated Portfolio. This advanceunderstanding does not authorize BARDA to share financial information outside
HHS . The Contractor is advised to review the terms of FAR C lause 52.227-14
regarding the Government's rights to deliverables submitted during performanceas well as the Government's rights to data contained with.in those deliverables.

f.

Overtime Compensation

g. Correction or Replacement of Items

Because the primary objective of this contract is not the delivery of end items
other than repo1ts, the Contractor will not be required to con ect or replace any
materiaJs that are produced in performance of this contract, unless s uch con ection
or replacement is directed b y the Contracting Officer and the cost of suchcorrection or replacement is reimbursable consistent with FAR 52.216-7,
Allowable Cost and Payment, to the extent that such cost is otherwise
allowable. Services that the Contractor provides under this contract will bedeemed acceptable if the Contractor is engaged in a reasonable effort to complete
the services in accordance with the Statement of Work. The Government will notbe responsible for the cost of correction or replacement if a failure by theContractor is due to (1) Fraud, lack of good faith, or willful misconduct on thepart of the Contractor's managerial personnel or (2) the conduct of one or more of
the Contractor' s employees selected or retained by the. Contractor after any of theContractor's managerial personnel bas reasonable grounds to believe that theemployee is habitually careless or unqualified.
,. Limited Rights Data
Notwithstanding any contrary representation by the Contractor on the System forAward Management or any contrary provision in this contract, the following
categories of information developed at p1ivate expense will, if provided to theGovernment, be considered limited rights data subject to the restrictions specified
in FAR 52.227-14, Alternate IL These restrictions apply to any component of
information covered by this provision, regardless of whether a component isincluded in a contract deliverable.

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENTARTICLE C.1. STATEMENT OF WORK
Independently and not as an agent of the Government, the Contractor shall furnish all
the necessary services, qualified personnel, material, equipment, and facilities nototherwise provided by the Government as needed to perform the Statement of Work
attached to this contract as Attachment 1 (SECTION J-List of Attachments).

ARTICLE C.2. REPORTING REQUIREMENTS
Refer to ARTICLE F.2. for specific instructions regarding Reporting Requirements.

ARTICLE C.3. EARNED VALUE MANAGEMENT SYSTEM (EVMS)
IMPLEMENTATION REQUIREMENTS
The Contractor and the Government agree that the EVMS implementation
requirements that are contained in this contract are limited to the implementation
requirements outlined by the 7 Principles of Earned Value Management Tier 2
System Implementation Intent Guide contained as Attachment 9 (See SECTION JList of Attachments) to the contract. Attachment 9 is provided as an example of aContract Performance Report. The total amount of this contract reflects the use of the
7 Principles of EVMS Implementation. Any EVMS implementation requirementsthat are beyond the intent of the 7 Principles of EVMS Implementation shall notproceed until the Contracting Officer sends a written request for a proposal to theContractor and a bilateral modification is issued to the contract for the purposes ofincorporating the additional costs for the performance of these requirements into thecontract.
Refer to ARTICLE F.2. for specifics on EVMS deliverables.

ARTICLE C.4. PROJECT MEETING CONFERENCE CALLS
A teleconference call between the Contracting Officer, Contracting Officer's
Representative and the Contractor's Program Manager shall occur bi-weekly (every
two weeks), or at the discretion of the Government. During this call, the Program
Manager will discuss the activities dming the reporting period, any problems thathave arisen, and the activities planned for the ensuing reporting period. The
Contractor's Program Manager may choose to include other key personnel on theconference call to give detailed updates on specific projects or this may be requestedby the Contracting Officer's Representative.

Contractor will be responsible for preparing an agenda for the conference call andproviding it to the Government no later than 2 business days prior to the scheduled
conference call.

ARTICLE C.5. PROJECT MEETINGSThe Contractor shall participate in Project Meetings to coordinate the performance ofthe contract, as requested by the Contracting Officer's Representative. Thesemeetings may include face-to-face meetings with BARDA/AMCG in Washington,
D.C. and at work sites of the Contractor and its subcontractors. Such meetings may
include, but are not limited to, meetings of the Contractor (and subcontractors invitedby the Contractor) to discuss study designs, site visits to the Contractor's andsubcontractor's facilities, and meetings with the Contractor and HHS officials to
discuss the technical, regulatory, and ethical aspects of the program. The Contractor
must provide data, reports, and presentations to groups of outside experts (subject toappropriate protections for Contractor confidential or proprietary data) and USG
personnel as required by the Contracting Officer's Representative in order to facilitate
review of contract activities.

a. Kickoff Meeting
The Contractor shall complete a Kickoff meeting within 30 days after contract award.
Contractor shall provide an itinerary/agenda no later than 5 business days before
meeting (deliverable).

b. Quarterly and Ad-Hoc Meetings
At the discretion of the Contracting Officer and/or Contracting Officer's
Representative, the Contractor shall participate in Project Meetings to coordinate theperformance of the contract. These meetings may include teleconferences or face-toface meetings with BARDA and/or AMCG in Washington, D.C. or at work sites of
the Contractor and its subcontractors. Such meetings may include, but are not limited
to, meetings of the Contractor (and subcontractors invited by the Contractor) to
discuss study designs, site visits to the Contractor's and subcontractor's facilities, andmeetings with the Contractor and HHS officials to discuss the technical, regulatory,
and ethical aspects of the program. The Contractor must provide data, reports, andpresentations to groups of outside experts (subject to appropriate protections forContractor's confidential or proprietary data) and Government personnel as requiredby the Contracting Officer's Representative, giving reasonable prior notice of suchrequirement to Contractor, in order to facilitate review of contract activities.
Contractor shall provide itinerary/agenda at least 5 business days in advance of faceto-face meeting (deliverable).

c. Face-to-Face Project Review Meetings

The Contractor shall, at a time to be detennined later, present a comprehensive review
of contract progress to date in a face-to-face meeting in Washington, DC. The
Contractor will be responsible for updating BARDA program on technical progressunder the Statement of Work. Presentation must be delivered seven (7) business days
prior to the scheduled meeting.

SECTION D - PACKAGING, MARKING, AND SHIPPINGAll deliverables required under this contract shall be packaged, marked and shipped inaccordance with Section F. At a minimum, all deliverables shall be marked with thecontract number and Contractor name. The Contractor shall guarantee that all requiredmaterials shall be delivered in immediate usable and acceptable condition
Unless otherwise specified by the Contracting Officer, delivery of reports to be
furnished to the USG under this contract (including invoices) shall be delivered to
AMCG and BARDA electronically along with a concurrent email notification to theContracting Officer, Contract Specialist, and COR (as defined in SECTION F.3.
ELECTRONIC SUBMISSION) summarizing the electronic delivery.

SECTION E - INSPECTION AND ACCEPTANCE
ARTICLE E.1. FAR 52.252-2, CLAUSES INCORPORATED BY REFERENCE(FEBRUARY 1998)
This contract incorporates the following clauses by reference, with the same force andeffect as if they were given in full text. Upon request, the Contracting Officer will maketheir full text available. Also, the full text of a clause may be accessed electronically atthese addresses: https://www.acquisition.gov/FAR/ . HHSAR Clauses at:
http://www.hhs.gov/policies/hhsar/subpart35 2.html.
FAR Clause

Title and Date

52.242-15

Stop Work Order (Aug 1989), Alternate I (Apr1984)
Inspection of Research and Development (ShortForm)(Apr 1984)

52.246-9

ARTICLE E.2. DESIGNATION OF GOVERNMENT PERSONNEL
For the purpose of this Section E, the designated Contracting Officer's Representative(COR) is the authorized representative of the Contracting Officer. The COR will assist
in resolving technical issues that arise during perfonnance. The COR however is not
authorized to change any contract terms or authorize any changes in the Statement of

Work or modify or extend the period of performance, or authorize reimbursement of any
costs incurred during performance.
ARTICLE E.3. INSPECTION, ACCEPTANCE AND CONTRACTMONITORING

Inspection and acceptance of the materials services and documentation called for hereinshall be accomplished by the Contracting Officer or a duly authorized representative.

Inspection and acceptance for report deliverables will be performed at:

Office of Acquisition Management, Contracts, and Grants (AMCG) Office of theAssistant Secretary for Preparedness and Response
U.S. Department of Health and Human Services 3 30 Independence Avenue, S.W.,
Room 0644 Washington, D.C. 20201
Inspection and acceptance for non-report deliverables will be performed at theContractor's or its subcontractor's facilities.
a. Site Visits and Inspections

At the discretion of the USG and independent of activities conducted by the Contractor,
with 48 hours' notice to the Contractor, the USG reserves the right to conduct site visits
and inspections on an as needed basis, including collection of product samples andintermediates held at the location of the contractor, or subcontractor for purposes directly
related to this contract. All costs reasonably incurred by the Contractor and subcontractor
for such visit and/or inspection shall be allowable costs subject to the Allowable costrequirements in FAR Subpart 31.2. The Contractor shall coordinate these visits and shallhave the opportunity to accompany the USG on any such visits. Under time-sensitive or
critical situations, the USG reserves the right to suspend the 48 hour notice to theContractor. The areas included under the site visit could include, but are not limited to:security, regulatory and quality systems, manufacturing processes and cGMP/GLP/GCP
compliance.
If the USG, Contractor, or any other party identifies any issues during an audit, theContractor shall capture the issues, identify potential solutions, and provide a report to the
USG for review and acceptance.

••

If issues are identified during the audit, the Contractor shall submit areport to the CO and COR within ten (10) business days detailing thefinding and proposed corrective action(s) of the audit.
COR and CO will review the report and provide a response to the•Contractor w ithin ten ( l 0) business days.
Once corrective action is completed, the Contractor will provide a final
report to the CO and COR.

SECTION F - DELIVERIES OR PERFORMANCEARTICLE F.1. ESTlMATED PERIOD OF PERFORMANCEThe estimated period of perfonnance for this contrnct shall be consistent with the dates
set forth in the base period CUN 0001 set forth in ARTICLE B.2. If the Government
exercises its Option(s) pursuant to the Option Clause of the contract, the period of
performance shall be increased as shown in the table in Atticle B.3.

ARTICLE F.2. DELIVERABLES
Successful performance of the fina l contract shall be deemed to occur upon completionof petfortnance o f the work set forth in Attachment 1, the Statement of Work dated l
September 2016, set forth in SECTION J - List of Attachments of this contract and upondelivery and acceptance, as required by the Statement of Work, by the Contracting
Officer, of each of the deliverables described in SECTION F and SECTION J.
A ll delrverables and reporting documents Listed w ithin tbjs section shall be delivered
electronically (as defined in SECTION F. 3. ELECTRONIC SUBMISSION) to the CO,CS, and the COR unless othe1wise specified by the Contracting Officer.

Summary of Contract Deliverables
Unless otherw ise specified by the Contracting Officer, the deliverables identified inthis SECTION F shall also be delivered electronically to the designated eRoom
along with a concurrent email notification sent to the Contracting Officer, Contract
Specialist, COR, and Alternate COR, if designated stating delivery has been made.

All paper/hardcopy docrnnents/reports submitted under this contract sh all be printed
or copied, double-sided, on at least 30 percent post-consumer fiber paper, wheneverpracticable, in accordance with FAR 4.302(b). Hard copies of deliverables andreports furnished to the USG1mder the resultant Contract (including invoices) shallbe addressed as fo llows:
HHS/ASPR/AMCG
ATTN: Wendell Conyers, Contracting Officer (CO)330 Independence Avenue, S.W., Room G640 Washington, D C 20201
Email: wendell.conyers@hhs.gov
HHS/AS PR/BARDA
ATTN: Karl Erlandson,

Contracting Officer's Representative (COR)
330 Independence Avenue, S.W.,
Washington, DC 20201
Email: Karl.Erlandson@hhs.gov

I . Summary of Contract Deliverables - Unless otherwise stated, each deliverable in

the table below shall be provided as one (1) electronic copy to the COR. CS, andCO as set f011h in SECTION D.

TECHNICAL DELIVERABLES
Item#

01

Delivel"able
Kickoff Meeting

Deliverable Description
The Contractor shall complete a
Kickoff meeting after contract award••

Reportin2 Procedures and Due Dates
Within a 30 days of contract award.

Contractor shall provide itinerary andagenda at least 5 business days in advanceof site visit.

• CO approves and distributes itinerary andagenda within 3 btisiness days.

• Contractor provides meeting minutes to•
02

Quarterly
Meetjngs

The Contractor shall hold recurring
teleconference or face-to-face Program
Review Meetings approximately every
third month either in Washington D.C
or at work sites of tbe Contractor or
subconLractors. The meetings will be
used to discuss contract progress inrelation to the Program Management
deliverables described below as well as
study designs. technical, regulatory.
and ethical. aspects of the program.

•
•
•
•

03

Bi-weekly
Teleconfere nee
Meetings

The Contractor shall participate in biweekly teleconferences with the COR
and CO to discuss the performance ofthe contract.

••

COR within 5 business days after the
meeting.
CO and COR reviews, comments, andapproves minutes withi11 10 business
days.
Contractor shall provide itinerary andagenda at least 5 business days in advanceof site visit to the CO and COR
CO and COR approves ,uid distributes
itinerary and agenda within 3 business
days.
Contractor provides meeting minutes to
COR within 5 business days after the
meeting.
COR reviews, comments, and approves
minutes within 10 business days.
Contractor provides agenda to CO and
COR no later than 2 business days inadvance of meeting.
COR approves and distributes agenda
prior to meeting.

Item#

Deliver.able

Deliverable Description••
04(Monthly)05(Annual)Monthly &Annual Technical
Progress Reports

The Monthly and Annual Technical
Progress report shall address eachof the below items and be crossreferenced to the Work Breakdown
Structure (WBS), Statement ofWork (SOW), Integrated Master
Schedule (IMS), Performance
Measurement Baseline Review
rep011 (PMBR), Earned ValueManagement (EVM), and Contract
Perforn1ance Report (CPR).
I .An Executive Swnmary
highlighting the progress, issues
and relevant manufacturing, nonclinical, clinical and regulatory
activities. The Executive
Summary should highlight only
critical issues for that reporting
period and resolutio n approach;limited to 2-3 pages.
2. Progress in meeting contract
milestones - broken out by
subtasks witl1in each milestone,
overall project assessment,
problems encountered andrecommended solutions. The
reports shall detail the planned
and actual progress during theperiod covered, explaining
occun-ences of any differences
between the two and theconective steps.
3.Tbe reports shall also include athree-month rolling forecast of
the key planned activities,
referencing the WBS/ IMS .
4.A tracking log of progress onregulatory submissions with the•

RePortin2 Procedures and Due Dates
Contractor provides meeting minutes to
CO and COR within 3 business days
following the meeting.
COR reviews, comments, and approves
minutes within IO business days
following the meeting.

Monthly Repon s shall be submitted on
the 20th day of the month after the end ofeach month with an Annual Repo11thsubmitted on the 30 calendar day of the
final month of each contract year for theprevious twelve calendar months.
Monthly progress reports are not required
for the periods when the Ammal
Report(s) and Final Report are due. The
COR and CO will review the monthly
reports with the Contractor and provide
feedback.

Item#

06

Deliverable

Earned ValueManagement(EVM) /
Contract
Performance
Report(CPR)

Deliverable Description

FDA number, description ofsubmission, date of submission,
status of submission and next
steps.
5.Provide updated EVM/CPR.
6.Estimated and Actual Expenses.
7.This report shall also contain anarrative or table detailingwhether there is a significant
discrepancy (> 10%) at this time
between the % of work
completed and the cumulative
costs incurred to date. Monthly
and actual expenses should be
broken down to the appropriate
WBS level. This section of thereport should also containestimates for the Subcontractors'
expenses from the previous
month if the Subcontractor did
not submit a bill in the previous
month. If the subcontractor(s)was not working or did not incur
any costs in the previo us month,then a statement to this effectshould be included in this reportfor those respective
subcontractors.
Contractor will provide a monthly
Contract Performance Report (CPR)
Format l at an agreed upon reportinglevel using the COR and CO provided

Reportine: Procedures and Due Dates•

WBS

and a Variance Analysis Report(Format 5).
The supplemental monthly CAP reportshall contain, at the work package
level , time phased budget (budgeted
cost of work scheduled), earned value(budgeted cost of work performed),
and actual costs of work performed as
captured in Contractor's EVM
systems.
The Contractor shall provide arationale in the package of its use of%complete as EVMS methodology oridentity whether any other EVMS•••

Contractor shall provide EVM/CPR aspart of the Monthly Progress Report on
the 20th day of the month after the end ofeach month (this requirement begins only
as set forth in the Contract Milestones &Related Deliverables table) to the CO and
COR.
Contractor shall provide top level or key
changes in baseline cost as a result of
anticipated cost savings or risks to the CO
and COR.
The Government may request, on amonthly o r ad hoc basis that theContractor provide raw d ata at a reportinglevel or lower level as COR deems
necessary.
The COR or CO may raise, in writing,Item#

Deliver.able

Reportim~ P rocedures and Due Dates
concerns for Contractor to address;
Contracto r must address, in writing, all

Deliverable Description
methodology is bejng used.

•07

Perfonnance
Measurement
Baseline Review(PMBR)PMBR Report shall address each of
the items listed below a nd be crossreferenced
to the IMP, WBS, SOW,
and Risk Management Plan .
I . Contractor-provided base~neproposal.
2. Responsibility Assignment Matrix.
3. A description of the work scopethrough control account Work
Authorization Documents and/or
WBS Dictiona.I'y down lo the control
account level.
4. Template for work packages.
5, lMS with the inclusion of agreed
major milestones and control
account plans for all control
accounts.
6. B aseline revision documentationand program log(s ) risk
management plan,

•
•
•
•

•
•

•
•
•

08

09

Risk Management
Plan

Deviation
Notificationand Mitigation

The Contractor shall provide a Risk
Management Plan that outlines theimpacts of each risk in relation to thecost, schedule, and perfonnanceobjectives. The plan shall include risk
mitigation strategies. Each risk
mitigation strategy will capture how
the corrective action will reduce
impacts on cost, schedule andperformance.

Process for changing IMS activities
associated with cost and schedule asbaselined at tbe PMBR. Contractor

•
•
•

•
•

•

concerns raised by COR.
Reporting will commence after the EVM
system has been implemented but no later
than 3 months after start o f base period..
Due within 90 days of contract awiu·d .
Contractor shaJI provide basel ine proposal
powerpoint briefing l O business days prior tomeeting lo the CO and COR.
Contractor provides agenda to CO and COR
2 business days in advance of meeting.
COR approves (with CO concurrence) anddistributes agenda no later than 2 businessdays in advance of meeting.
COR approves (with CO ooncunence) all
meeting material no later than 2 businessdays in advance of meeting.
Ct:mtactor provides minutes within 5 businessdays of tJ1e meeting.
COR reviews and approves (with CO
concwTence) minutes.
the COR and CO will review documentationand provide written comments and qllestions
to Contractor.
Contractor shall address the COR and CO'scomments and resubmit PMBR report for the
COR and CO
approval within 10 business days.
Due within 60 days of contract award .
Contractor provides updated Risk
M anagement P lan in Monthly Progress
Report.
The COR shall provide Contractor with awritten list of concerns in 1·esponse plan
supmitted.
Contractor must address, in writing, allconcerns raised by the COR and CO within
20 business days of Contractor 's receipt of
the COR and CO's concem s.
Due as needed .

Item#

Deliverable
Strategy

10

Go/No-Go
Decision
Gate Presentation

Deliverable Description
shall notify the COR and CO ofsignificant
changes the IMS defined as increases
in cost above 5% or schedule slippageof more than 30 days, which would
require a PoP extension. Contractor
shall provide a high level management
strategy for risk mitigation.
Contractor shall provide a presentation
detailing technical progress madetowards completion of Go/No-Go
decision gate milestones following aprescribed template provided by
the COR and CO prior to the IPR.

Reportin2 Procedures and Due Dates

•
•

•
11

Incident Report

Contractor shall communicate anddocument all critical programmaticconcerns, risks, or potential risks with
the COR and CO.

•
•
•

•

•

12

Draft and Final
Reports forClinical, PreClinicaland Non-ClinicalStudies

Contractor shall provide Draft andFinal
Clinical/Non-Clinical Study Reports to
the COR and CO for review andcomment.

•••

Contractor shall provide presentation in
powerpoint format 10 business days prior to
the In-Process Review (IPR).
Contractor shall submit written justificationof progress towards satisfyi ng Go/No-Go
criteria.
After reviewing, COR and CO will provide awritten response.
Due within 48 hours of activity or incident orwithin 24 hours for a security activity or
incident.
Email or telephone with written follow-up to
COR and CO.
Additional updates due to COR and CO
within 48 hours of additional developments.
Contractor shall submit within 5 businessdays a Corrective Action Plan (if deemednecessary by either party) to address any
potential issues.
If corrective action is deemed necessary,
Contractor must address in writing, itsconsideration of concerns raised by the COR
and CO within 5 business days of receivingsuch concerns in writing.
Draft report due within 45 calendar days after
completion of analysis and at least 15
business days prior to submission to FDA.
Subcontractor prepared reports received by
the Contractor shall be submitted to theContracting Officer's Representative andContracting Officer (CO) for review andcomment no later than 5 business days after
receipt by Contractor.
The Government shall provide writtencomments to the Draft Final Report forItem#

Deliverable

Deliverable Description

•

•
•
13

Standard
Operating
Procedures

14

Manufacturing
Campaign Reports

The Contractor shall make internal
and, to the extent possible,
subcontractor Standard Operating
Procedures (SOPs) available forreview electronically.
Contractor shall provide
Manufactming
Campaign Reports to the COR and CO
forreview and comment prior to
submission to FDA.
The COR and CO reserve the right torequest within the PoP an unredacted
Manufacturing Campaign Report for
distribution within the USG.

•

Upon request from the COR/Contracting
Officer.

•

Contractor will submit Manufacturing
Campaign Reports at least 15 business days
prior to FDA submission.
If corrective action is recommended,
Contractor must address, in writing, allconcerns raised by the COR and CO in
writing.
Contractor shall consider revising reports toaddress the COR and CO's concerns and/or
recommendations prior to FDA submission.
Final FDA submission shall be submitted to
the COR and CO concurrently or no later
than 1 business day after submission to the
FDA.

•

•
•

15

FDA
Correspondence

16

FDA Meetings

The Contractor shall memorialize any
correspondence between Contractor
and FDA and submit to the COR and
CO. All documents shall be duly
marked as either "Draft" or "Final".
The Contractor shall forward the dates
and times of any meeting with the
FDA to the COR and CO and makearrangements for appropriate BARDA
staff to attend the FDA meetings.
BARDA staff shall include up to a
maximum of four people (COR, CO

Reportin2 Procedures and Due Dates
Clinical and Non-Clinical Studies within 15
business days after the submission.
Final report due 30 calendar days after
receiving comments on the Draft Final Report
for Clinical and Non-Clinical Studies. If
corrective action is recommended, Contractor
must address, in writing, all concerns raisedby the COR and CO in writing.
Contractor shall consider revising reports toaddress the COR's recommendations prior to
FDA submission
Final FDA submissions shall be provided to
the COR concurrently or no later than 1business day after submission to the FDA.

•

Contractor shall provide written summary of
any FDA correspondence within 5 businessdays of correspondence.

•Contractor shall notify the COR and CO of
upcoming FDA meeting within 24 hours ofscheduling Type A, B or C meetings OR
within 24 hours of meeting occurrence for ad
hoc meetings.
The Contractor shall forward initial
Conti-actor and FDA-issued draft minutes and•Item#

Deliverable

17

FDA PreSubmissions,
Submissions, andcorrespondence

Deliverable Description
and up to 2 subject matter experts).

The Contractor shall provide the COR
and CO the opportunity to review andcomment upon all draft submissions
directly related to this contract before
submission to the FDA. Contractor
shall provide the COR and CO with anelectronic copy of the final FDA
submission. All documents shall be
duly marked as either "Draft" or"Final".

Reportine: Procedures and Due Dates
final minutes of any meeting with the FDA to
the COR and CO within 2 business days ofreceipt. All documents shall be duly marked
as either "Draft" or "Final".

•

•
•

•

•
18

FDA Audits

In the event of an FDA inspection
which occurs as a result of thiscontract and for the product, or for any
other FDA inspection that has thereasonable potential to impact theperformance of this contract, theContractor shall provide the USG withan exact copy (non-redacted) of the
FDA Form 483 and the Establishment
Inspection Report (EIR). The
Contractor shall provide the COR and
CO with copies of the plan foraddressing areas of non-conformanceto FDA regulations for GLP, GMP, or
GCP guidelines as identified in theaudit report, status updates during theplans execution and a copy of all fi nal
responses to the FDA. The Contractor
shall also provide redacted copies of
any FDA audits received fromsubcontractors that occur as a result of
this contract or for this product. The
Contractor shall make arrangements
for BARDA representative(s) to bepresent during the final debrief by the

•

•

•

Contractor shall submit draft FDA
submissions to the COR and CO at least 15
business days prior to FDA submission.
The COR and CO will provide feedback toContractor within 5 business days of receipt.
If corrective action is recommended, theContractor must address, in writing, itsconsideration of all concerns raised by the
COR and CO.
The Contractor shall consider revising their
documents to address the COR and CO'sconcerns and/or recommendations prior to
FDA submission.
Final FDA submissions shall be submitted to
the COR and CO concurrently or no later
than I calendar day of its submission to FDA
Contractor shall notify CO and COR within
10 business days of a scheduled FDA audit orwithin 24 hours of an ad hoc site visit/audit if
the FDA does not provide advanced notice.
Contractor shall provide copies of any FDA
audit report received from subcontractors that
occur as a result of this contract or for thisproduct within 5 business days of receiving
correspondence from the FDA or third party.
Within 10 business days of audit report,
Contractor shall provide CO and COR with aplan for addressing areas of nonconformance,
if any are identified.

Item#

Deliver.able

19

QA Audit Repo11s

20

BARDA Audit

Deliverable Description
regulatory inspector.
The Government reserves the right toparticipate in QA audits. Uponcompletion of the audit/site visit theContractor shall provide a report
capturing the findings, reSltlts and next
steps in proceeding w ith thesubcontractor. If action is requested ofa subcontractor, detailed concerns foraddressing areas of non-conformance
to F DA regulations for GLP, GMP, or
GCP guidelines, as identified in theaudit report, must be provided to the
COR and CO. The Contractor shallprovide responses from thesubcontractors to address theseconcerns and plans for corrective
action execution.
Contractor shalJ accommodate periodic
or ad hoc site visits by theGovernment. If the Government, theContractor, or other parties identifies
any issues during au audit, theContractor shall capture the issues,
identify potential so lutions, andprovide a report to the COR and CO.

Reporting Procedures and Due Dates•

Contractor shall notify CO and COR lO daysin advance of upcoming. ongoing, or recent
audits/site visits of subcontractors as part ofweekly communications.

•Contractor shall notify the COR and CO
within 5 business days of report completion.

• If issues are identified during the audit,••

Contractor sh all submit a report to the CO
and COR detailing the finding andproposed con-ective action(s) within 10
business days of the audit.
COR and CO will review the rep011 andprovide a response to the Contractor with
10 business days.
Once conective action is completed, theContractor will provide a final report to
CORandCO.

21

TecJmica1
Documents

Upon request, Contractor shall provide
CO and COR with deliverables fromthe following contract funded
activities! b}f4)
I
I
I

•

(bJI4)•

Contractor shall provide technical document
within l Obusiness days of CO or COR
request. Contractor can request additionaltime o n an as needed basis.
If corrective action is recommended, theContractor must address, in writing, concerns
raised by the COR and CO in writing.

>)(4)

22

Animal Model or
OtJ1er Technology
Transfer Package

ITheCO andCOR reserve the right to request within
the PoP an unredacted technicaldocument for distribution within the
Government .
Contractor shall provide Animal
Modelor Other Technology T ransfer Package•

Contractor shall provide data within I0
business days of COR or CO request.

Item#

Deliverable

23

Raw Data or Data
Analysis

24

Product Transition
Strategy25

Publications andPresentations

Deliverable Description
relevant data.
Contractor shall provide raw data ordata analysis to the Government uponrequest.
Contractor shaJl provide a 2-4 page
summary document containing a
Product Transition Strategy to supporl
transition of the product(s) prior to endof the base and/or option(s) POP. The
Product Transition Strategy should
provide a strategic plan for further
development and/or stockpiling of the
product. The transition strategy shallprovide options and/or a specificapproach for the transition of MCM
product for further development,
procurement, approval and/or
stockpile.
Any manuscript, scientific meeting
abstract, or poster containing data
generated under this conu·act must be,~ubmitted t0 the.COR and CO forreview prior to submission.

Reporting Procedu.res and 0Qe Dates•

Contractor shaJl provide data or data analysis
to CO and COR within 20 business days ofrequest.

•Contrnctor shaJJ provide a Product Transition
Strategy to support transition of the
product(s) 90 days prior to the end of the(base/option) POP as addendum to the
Quarterly Project Status Report.

•

Contractor must submit all manuscript orscientific meeting abstract(.s) to COR and CO
within 30 business days before submission
for publication for manuscripts and L5
business days for abstracts and presentations.
Contractor must address in w1iting allconcerns raised by the COR and CO in
writing.
Final submissions shall be submitted to the
COR and CO concuITently or no later thanone ( l ) calendar day of its submission.
With the exception ofad-hoc press releases
required by applicable law or regulations,Contractor shaJl ensme that the CO and COR
has received and approved an advanced copyof any press release to this contract not lessthan 5 business days prior to the issuance ofthe press release.
If coJTective action is required, the Contractor
agrees to accurately and factually represent
the work conducted under this contract in allpress releases.
Any final press releases shall be submitted lo
the COR and CO no later than I (one)calendar day prior to its release.
Contractor shall provide the draft IMP within
180 days of contract award with final due 8months after award and updated monthly as
part of the Monthly Progress Report.
Contmctor must address, in writing. all

•

•
26

Press Releases

Contractor agrees to accw·ately andfachiaJ ly represent the work conductedunder this contract in all press releases.

•

•

•
27

Integrated Master
Plan (IMP)The Contractor shall provide an IMP
i11cluding WBS, critical path
milestones, and Earned ValueManagement Plan_••

Item#

Deliverable

Deliverable Description

28

Draft Final andFinal Report

A Draft Final Report containing asummation of the work performed andthe results obtained for the entire
contract PoP. The draft report shall be
duly marked as 'Draft'.
The Final Report incorporating
feedback received from the COR and
CO and containing a summation of thework performed and the results
obtained for the entire contract PoP.
The final report shall document theresults of the entire contract. This
report shall be in sufficient detail tofully describe the progress achieved
under all milestones. The final reportshall be duly marked as 'Final' .

29

Draft and Final
Study Protocols

Contractor shall provide all Draft
and Final Study Protocols to theGovernment for evaluation. (TheCO and PO reser ves the right torequest within the period of
performance an unredacted Study
Protocol for distribution within the
U nited States Government (USG)

•

•

•

•

•

•

•

30

Clinical Study
Status Update

Contractor shall provide COR with astatus update of clinical studies that are
actively enrolling patients to include•

Reportin2 Procedures and Due Dates
concerns raised by COR in writing.
Contractor shall provide a Draft Final Report
75 calendar days before the end of the PoP
and the Final Report on or before thecompletion date of the PoP.
Subcontractor prepared reports received by
the Contractor shall be submitted to the COR
and CO for review and comment no later than
5 business days after receipt by theContractor.
COR shall provide feedback on draft report
within 15 calendar days of receipt, which theContractor shall consider incorporating into
the Final Report.
Contractor shall submit, with the Final
Report, a summary (not to exceed 200 words)of salient results achieved during theperformance of the contract.

The Contractor will submit all proposed
protocols to COR and CO at least 10
business days prior to study start. If
co1Tective action is required, theContractor must address in writing allconcerns raised by the Government to thesatisfaction of the Government before
study execution and provide BARDA arevised draft protocol that addresses theGovernment' s comments and requestedchanges.
After receiving the revised Study Protocolthat satisfies the Government, the CO and
COR will approve the revised Study
Protocol and will provide a written
approval to the Contractor that provides
authorization to the Contractor to executethe sp ecific study.
Contractor shall not proceed with any
study protocol until COR and CO gives
its approval and the Contractor has
provided BARDA with a final andapproved Study Protocol.
Update will be submitted by e-mail or otherelectronic format to be provided by the COR

Item#

Deliver.able

Deliverable Descriptfon

Reportiu2 Procedures and Due Datesby study site: cumulative emollment;
new enrollments; screen failures;
patients dropped from study; AE andSAEs; activation or inactivation of
study sites; investigator appointmentsor changes; and status of IRB/IEC
review/approval/renewal. Contractor
will provide proposed format for
COR and CO review and approval .
31

Samples ofTherapeutics

Contractor shall provide samples of
GMP material manufac tured with
contract funding to include raw
material, Bulk Drug Substance(BOS), Final Drug Product (FOP)
and/or labeled and ~ackaged
treatment courses. f4>

•

•
•

•

I

and CO the Monday following the week
being reported during active enrollment
periods
Updates, to the extent they are available, will
be presented during monthly teleconferences.
Lf no changes have occurred since lhe priorupdate only a simple statement that there isno new data is required.
Couu·actor must submit samples oftherapeutics within 20 business days ofrequest by CO/COR.
The Contractor will be advised by the CO
how samples are to be packaged andwhere samples are to be s hipped,lb)t4)

NOTE: Pursuant to federal law, no Government personnel shall publish , divulge,
disclose, or otherwise make known to any non-government entity an y Contractor data
marked according to FAR 52.227~ 14, Alternate II, unless permitted to do so by law or
regulation.
2. Detailed Description of Select Contract Deliverables
A. Monthly and Annual Progress Reports

In addition to those reports required by the other terms of this contract, the Contractor
shall prepare and submit the following reports in the manner stated below and inaccordance withthis Article F of this contract, and in the Statement of Work, attached to this contract
as Attachment 1 (SECTION J-List of Attachments).
1.

Monthly Progress Report
This report shall include a description of the activities during the reporting
period, and the activities planned for the ensuing reporting period. The
first reporting period consists of the first full month of performance plus
any fractional part of the initial month. Thereafter, the reporting period
shall consist of each calendar month.
The Contractor shall submit a Monthly Progress Report according to thedates set forth in the summary table ("Summary of Contract
Deliverables") under this article. The progress report shall conform to therequirements set forth in the DELIVERABLES Article in SECTION F ofthis contract.
The format should include:
•

•
•
•
•

•

A cover page that includes the contract number and title; the typeof report and period that it covers; the Contractor's name, address,
telephone number, fax number, and e-mail address; and the date ofsubmission;
SECTION I -EXECUTIVE SUMMARYSECTION II - PROGRESSSECTION II Part A : OVERALL PROGRESS - A description of
overall progress.
SECTION II Part B: MANAGEMENT AND ADMINISTRATIVEUPDATE - A description of all meetings, conference calls, etc.
that have taken place during the reporting period. Include progresson administration and management issues (e.g., evaluating, andmanaging subcontractor performance, and personnel changes).
SECTION II Part C: TECHNICAL PROGRESS - For each activity
related to Gantt chart, document the results of work completed andcost incurred during the period covered in relation to proposed
progress, effort and budget. The report shall be in sufficient detail
to explain comprehensively the results achieved. The description
shall include pertinent data and/or graphs in sufficient detail toexplain any significant results achieved and preliminary
conclusions resulting from analysis and scientific evaluation ofdata accumulated to date under the contract. The report shall

•

•

•

include a description of problems encountered and proposedcorrective action; differences between planned and actual progress,
why the differences have occurred and what corrective actions areplanned; preliminary conclusions resulting from analysis andscientific evaluation of data accumulated to date under the project.
SECTION II Part D: PROPOSED WORK - A summary of work
proposed related to Gantt chart for the next reporting period andpreprints/reprints of papers and abstracts.
SECTION III: Estimated and Actual Expenses.
a. This section of the report shall contain a narrative or tabledetailing whether there is a significant discrepancy (>10%) at thistime between the% of work completed and the cumulative costs
incurred to date. Monthly and actual expenses should be broken
down to the appropriate WBS level.
b. This section of the report should also contain estimates for the
Subcontractors' expenses from the previous month if the
Subcontractor did not submit a bill in the previous month. If thesubcontractor(s) was not working or did not incur any costs in theprevious month, then a statement to this effect should be includedin this report for those respective subcontractors.
SECTION IV: Earned Value Management Reporting: Contractor
will provide a monthly Contract Performance Report (CPR) at anagreed upon reporting level (WBS level 3) using the AMCG
provided WBS and a Variance Analysis Report. EVMS shall beapplied to all CLINs as part of the Integrated M aster Project Planfollowing the Seven Principles of Earned Value Management. In
accordance with FAR 52.215-2, Audit and Records-Negotiation,
BARDA may request, on a quarterly or ad hoc basis, that theContractor provide raw data. The Government may request
additional data at a reporting level or at lower levels, as theGovernment deems necessary.

A Monthly Progress Report will not be required in the same month that
the Annual Progress Report is submitted.
11.

Annual Progress Report
This report shall include a summation of the results of the entire contract
work for the period covered. Monthly Progress Reports shall not be
submitted in the same month when an Annual Progress Report is due.
Furthermore, an Annual Progress Report will not be required for theperiod when the Final Report is due.

The first Annual Progress Report shall be submitted in accordance withthe date set forth in the table ("Summary of Contract Deliverables") under
ARTICLE F.2. of this contract. The progress report shall conform to therequirements set forth in the DELIVERABLES Article in SECTION F ofthis contract.
Each Annual Progress Report shall include:
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A Cover page that includes the contract number and title; the typeof report and period that it covers; the Contractor's name, address,
telephone number, fax number, and email address; and the date ofsubmission;
SECTION I: EXECUTIVE SUMMARY - A brief overview of thework completed, and the major accomplishments achieved during
the reporting period.
SECTION II: PROGRESSSECTION II Part A: OVERALL PROGRESS - A description of
overall progress.
SECTION II Part B: MANAGEMENT AND ADMINISTRATIVEUPDATE - A high level summary of critical meetings, etc. thathave taken place during the reporting period. Include progress on
administration and management to critical factors of the project(e.g. regulatory compliance audits and key personnel changes).
SECTION II Part C: TECHNICAL PROGRESS - A detailed
description of the work performed structured to follow theactivities and decision gates outlined at the Integrated Baseline
Review and as described in the Integrated Master Plan. The Report
should include a description of any problems (technical or
financial) that occurred or were identified during the reporting
period, and how these problems were resolved.
SECTION II Part D: PROPOSED WORK - A summary of work
proposed for the next year period to include an updated Gantt
Chart.
SECTION ill: Estimated and Actual Expenses.
a. This section of the report shall contain a narrative or tabledetailing whether there were discrepancies between estimated andactual expenses over the past year. Actual expenses should be
broken down to the appropriate WBS level. This section of thereport should also contain estimates for outstanding costs for theprevious year which may have been incurred, but not yet billed.

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SECTION IV: EARNED VALUE MANAGEMENTREPORTING - Contractor will provide a quarterly Contract
Performance Report (CPR) at an agreed upon (WBS level 3)
reporting level using the AMCG provided WBS and a Variance
Analysis Report. EVMS shall be applied to all Cost CLINs as partof the Integrated Master Project Plan following the Seven
Principles of Earned Value Management. In accordance with FAR
52.215-2, Audit and Records-Negotiation, the COR may request,
on a quarterly or ad hoc basis, that the Contractor provide raw data.
The COR or CO may request additional data at a reporting level orat lower levels, as BARDA deems necessary.

Contractor also should include the following in the Annual Progress
Report:1. Copies of manuscripts (published and unpublished), abstracts,
and any protocols or methods developed specifically under thecontract during the reporting period; and2. A summary of any Subject Inventions per the requirements
under FAR Clause 52.227-1 1.
iii. Draft Final Report and Final Report
These reports are to include a summation of the work performed andresults obtained for the entire contract period of performance. This reportshall be in sufficient detail to describe comprehensively the results
achieved. The Draft Final Report and Final Report shall be submitted inaccordance with the DELIVERABLES Article in SECTION F of thecontract. An Annual Progress Report will not be required for the period
when the Final Report is due. The Draft Final Report and the Final Reportshall be submitted in accordance with the dates set forth in the table("Summary of Contract Deliverables") under ARTICLE F.2. of thiscontract. The report shall conform to the following format:
1. Cover page to include the contract number, contract title,
performance period covered, Contractor's name and address,
telephone number, fax number, email address and submission
date.

2. SECTION I: EXECUTIVE SUMMARY - Summarize thepurpose and scope of the contract effort including a summary of
the major accomplishments relative to the specific activities set
forth in the Statement of Work.

3. SECTION II: RESULTS - A detailed description of the work
perfmmed related to WBS and Gantt chart, the results obtained,
and the impact of the results on the scientific and/or public healthcommunity including a listing of all manuscripts (published andin preparation) and abstracts presented during the entire period of
perfo1mance and a summary of all inventions.
Draft Final Report: The Contractor is required to submit the Draft Final
Report to the Contracting Officer's Representative and Contracting
Officer. The Contracting Officer's Representative and Contracting Officer
will review the Draft Final Report and provide the Contractor withcomments in accordance with the dates set forth in ARTICLE F.2. of thiscontract.
Final Report: The Contractor will deliver the final version of the Final
Report on or before the completion date of the contract. The final version
shall include or address the COR's and CO's written comments on thedraft report. Final Report shall be submitted on or before the completion
date of the contract.
1v. Summary of Salient Results
The Contractor shall submit, with the Final Report, a s ummary (not toexceed 200 words) of salient results achieved during the performance ofthe contract.
v.

Audit Reports
Within thirty (30) calendar days of an audit related to conformance to
FDA regulations and guidance, including adherence to GLP, GMP, GCP
guidelines, the Contractor shall provide copies of the audit report (so longas received from the FDA) and a plan for addressing areas ofnonconformance to FDA regulations and guidelines for GLP, GMP, or
GCP guidelines as identified in the final audit report.

v1.

Other Technical Reports
1. Draft R eport for Clinical and Non-Clinical Studies and Final R eport
for Clinical and Non-Clinical Studies•

The clinical trial reports shall follow the format of International
Conference on Harmonization document ICH E3 "Guideline for Industry
on Structure and Content of Clinical Study Reports"

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Draft Final Report for Clinical and Non-Clinical Studies funded bythis contract w ill be submitted to the Contracting Officer's
Representative and Contracting Officer (CO) for review andcomment within the time frames set forth in the table ("Summaryof Contract D eliverables'') under ARTICLE F.2.
Subcontractor prepared reports received by the Contractor shall be
submitted to the Contracting Officer's Representative andContracting Officer (CO) for review and comment as set forth by
the table in this Article. Contractor shall consider revising rep orts
to address BARDA's reco1mnendations prior to FDA submission.
The Government shall provide written comments to the Draft Pinal
Report for Clinical and Non-Clinical Studies in accordance w ith
the dates set forth b y the table in this Article.
The comprehensive Final R eport for Clinical and Non-ClinicalStudies will be submitted to the Contracting Officer and theContracting Officer's Representative set forth by the table in this
Article.

2. Supplemental Technical Documents
Upon request, Contractor shall provide CO and COR with thefollow ing contract funded documents as specified below but notlimited to : ~X4)I

The CO and COR reser ve the right to request w ithin the Period of
Performance an unredacted techn ical document for distribution
within the USG Contractor shall provide technical document
within l O business days of CO or COR request. Contractor canrequest additional time on an as needed basis. If edits arerecommended, the Contractor must address, in writing, concerns
raised by COR and CO in writing.

A. Deliverables Arising from FDA Correspondence
1.

FDA Meetings
The Contractor sbalJ forward the dates and times of any meeting with the
FDA to COR and make arrangements for appropriate Government staff toattend the FD A meetings. The Government s taff shall include up to a
maximum of fow- people (COR, CO and up to 2 subject matter experts).

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Contractor shall notify COR of upcoming FDA meeting within 24 hours
of scheduling Type A, B or C meetings OR within 24 hours of meeting
occurrence for ad hoc meetings.
The Contractor shall forward initial Contractor and FDA-issued draft
minutes and final minutes of any meeting with the FDA to COR within 2
business days of receipt. All documents shall be duly marked as either"Draft" or "Final."

FDA Submissions
The Contractor shall provide COR all documents submitted to the FDA directly
related to this contract.
Contractor shall provide COR with an electronic copy of the final FDA
submission. All documents shall be duly marked as either "Draft" or "Final."•••

If draft documents are submitted for COR review, COR will provide
feedback to Contractor within 10 business days of receipt.
If COR reviews draft documents, the Contractor shall consider revising
their documents to address COR's written concerns and/or
recommendations prior to FDA submission.
Final FDA submissions shall be submitted to COR concurrently or nolater than 1 calendar day of their submission to FDA.

iii. FDA Audits
In the event of an FDA inspection which occurs as a result of this contract andfor the product, or for any other FDA inspection that has the reasonable potential
to impact the performance of this contract, the Contractor shall provide the USG
with an exact copy (non-redacted) of the FDA Form 483 and the Establishment
Inspection Report (EIR) within five (5) business days after the Contractors
receipt of those documents. The Contractor shall provide the COR and CO withcopies of the plan for addressing areas of non-conformance to FDA regulations
for GLP, GMP, or GCP guidelines as identified in the audit report, status updates
during the plans execution and a copy of all final responses to the FDA. The
Contractor shall also provide redacted copies of any FDA audits received fromsubcontractors that occur as a result of this contract or for this product. The
Contractor shall make arrangements for the Government representative(s) to bepresent during the final debrief by the regulatory inspector.

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Contractor shall notify CO and COR within 10 business days of ascheduled FDA audit or within 24 hours of an ad hoc site visit/audit if
the FDA does not provide advanced notice.
Contractor shall provide copies of any FDA audit report received fromsubcontractors that occur as a result of this contract or for this productwithin 5 business days of receiving correspondence from the FDA,
Subcontractor, or third party.
W ithin 10 business days of audit report, Contractor shall provide COwith a plan for addressing areas of nonconformance, if any are
identified.

1v. Manufacturing Campaign Reports

Contractor shall provide Manufacturing Campaign Reports to COR for review
and comment prior to submission to FDA.
The COR and CO reserve the right to request within the Period of Performance(PoP) an unredacted Manufacturing Campaign Report for distribution within the
USG
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Contractor will submit Manufacturing Campaign Reports at least 15
business days prior to FDA submission.
If corrective action is recommended, Contractor must address, in writing,all concerns raised by COR.
Contractor shall consider revising the reports to address COR's concerns
and/or recommendations prior to FDA submission.
Final FDA submission shall be submitted to COR concurrently or no later
than 1 business day after submission to the FDA.

8. Other FDA Correspondence
The Contractor shall memorialize any correspondence between Contractor and
FDA and submit to BARDA. All doc uments shall be duly marked as either"Draft" or "Final." Contractor shall provide written summar y of any FDA
correspondence within 5 business days of correspondence.
C. Earned Value Management (EVM) Deliverables
1.

Earned Value Management (EVM) / Contract Performance Report(CPR)Contractor will provide a monthly CPR at an agreed upon reporting level
using WBS and Variance Analysis report formats agreed upon by COR
and CO.
The supplemental monthly Control Account Plan (CAP) report shallcontain, at the work package level, time phased budget (budgeted cost ofwork scheduled), earned value (budgeted cost of work performed), andactual costs of work performed as captured in Contractor's EVM systems.
The Contractor shall provide a rationale in the package of its use of %complete as EVMS methodology, or identity if any other EVMS
methodology is being used.
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Contractor shall provide EVM/CPR as part of the Monthly Progress
Report (this requirement begins only as set forth in the Contract
Milestones & Related Deliverables table, see CDRL #4)
Contractor shall provide top level or key changes in baseline cost as aresult of anticipated cost savings or risks
The COR may request, on a monthly or ad hoc basis that theContractor provide raw data at a reporting level or lower level as COR
deems necessary.
Contractor must address, in writing, all concerns raised by theGovernment.
Reporting will commence after the EVM system has been
implemented but no later than 3 months after start of base period.

Integrated Master Plan (IMP)The Contractor shall provide an IMP including WBS, critical path
milestones, and Earned Value M anagement Plan
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Contractor shall provide the draft IMP within 180 days of contract
award with final due 8 months after award and updated monthly as
part of the Monthly Progress Report
Contractor must address, in writing, all concerns raised by theGovernment.

Performance Measurement Baseline Review (PMBR)
PMBR Report shall address each of the items listed below and be crossreferenced to the IMP, WBS, SOW, and Risk Management Plan.
1. Contractor provided baseline proposal

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1v.

2. Responsibility Assignment Matrix
3. A description of the work scope through control account Work
Authorization Documents and/or WBS Dictionary down to theagreed upon control account level.
4. Template for work packages
5. Integrated Master Schedule (IMS) with the inclusion of agreed
major milestones and control account plans for all control
accounts
6. Baseline revision documentation and program log(s) risk
management plan
PMBR is due within 90 days of contract award
Contractor shall provide baseline proposal .ppt briefing 10
business days prior to meeting
Contractor provides agenda to COR 2 business days in advance ofmeeting
COR approves (with CO concurrence) and distributes agenda
COR approves (with CO concurrence) all meeting material
Contactor provides minutes with 5 business days of the meeting
COR reviews and approves (with CO concurrence) minutes
The Government will review documentation and provide writtencomments and questions to Contractor
Contractor shall address the Government's comments and resubmit
PMBR report for COR approval within 10 business days.

Risk Management Plan
The Contractor shall provide a Risk Management Plan that outlines theimpacts of each risk in relation to the cost, schedule, and performance
objectives. The plan shall include risk mitigation strategies. Each risk
mitigation strategy will capture how the corrective action will reduce
impacts on cost, schedule and performance.
• Due within 90 days of contract award• Contractor provides updated Risk Management Plan in Monthly
Progress Report• The CO or COR shall provide Contractor with a written list ofconcerns in response plan submitted• Contractor must address, in writing, all concerns raised by theGovernment within 20 business days of Contractor' s receipt of theGovernment's concerns.

v.

Requirement for Notification of Deviation and Mitigation Strategy
Process for changing IMS activities associated with cost and schedule asbaselined at the PMBR. Contractor shall notify BARDA of significant
changes the IMS defined as increases in cost above 5% or scheduleslippage of more than 30 days, which would require an extension to theperiod of performance. Contractor shall provide a high level management
strategy for risk mitigation. Notice due as needed.

ARTICLE F.3. ELECTRONIC SUBMISSION
For electronic delivery, the Contractor shall upload documents to the appropriate folder
on https://eroom.bardatools.hhs.gov/eRoom ("eRoom") which is the designated USG
file sharing system. The USG shall provide two contractor representatives authorized
log in access to the file share program. Each representative must complete a mandatory
training provided by the USG prior to gaining user access. A notification email should
be sent to the CO and COR upon electronic delivery of any documents.

ARTICLE F.4. SUBJECT INVENTION REPORTING REQUIREMENT
All reports and documentation required by FAR Clause 52.227- 11, Patent RightsOwnership by the Contractor, including, but not limited to, the invention disclosure
report, the confirmatory license, and the government support certification, one copy ofan annual utilization report, and a copy of the final invention statement, shall be
submitted to the Contracting Officer. A final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted to the Contracting Officer on the expiration date of thecontract.
Reports and documentation submitted to the Contracting Officer shall be sent to theaddress set forth in SECTION G - CONTRACT ADMINISTRATION DATA.

If no invention is disclosed or no activity has occurred on a previously disclosed
invention during the applicable reporting period, a negative report shall be submitted to
the Contracting Officer at the address listed above.

Contract WBS Milestones/Deliverables and Technical Deliverable-s

agt' 053 lo Page 05-1

Wlll\helcl purSllanl lo exemption

D)(4!
f the Freedom ol lnformallon Ad

SECTION G- CONTRACT ADMINISTRATION DATAARTICLE G.1. CONTRACTING OFFICER
The following Contracting Officers (CO) will represent the USG for the purpose of thisconh·act:
Wendell Conyers
Contracting Officer
DHHS/OS/ASPR/AMCG
330 Independence Avenue, S.W. Room G640 Washington, D.C. 20201(202) 205-8262
Wende LI .conyers@hhs.gov
Okechukwu Obi
Contract Specialist
HHS/ASPR/AMCG
330 Independence Ave., S.W., Room 0640
Washington, DC 20201(202) 260-0625
Okechukwu.Obi@hbs.gov
1) The Contracting Officer is the only individual who can legally commit theGovernment to the expenditure of public funds. No person other than the Contracting
Officer can make any changes to the terms, conditions, general provisions, or otherstipulations of this contract.
2) The Contracting Officer is the only person with the authority to act as agent of theGovernment under this contrnct. Only the Contracting Officer has authority to ( 1)direct or negotiate any changes in the statement of work; (2) modify or extend theperiod of performance; (3) change the delivery schedule; (4) authorize reimburse to
the Contractor of any costs incuned during the performance of tl1is contract; (5)otherwise change any terms and conditions of this conuact.
3) No information other than that which may be contained in an authorized modification
to this contract, duly issued by the Contracting Officer, which may be received fromany person employed by the US Government, other otherwise, shall be consideredgrounds for deviation from any stipulation of this contract.
4) The Government may unilaterally change its CO designation, after which it will
notify Contractor in writing of such change.

ARTICLE G.2. CONTRACTING OFFICER'S REPRESENTATIVE (COR)
The following Contracting Officer's Representative (COR) will represent the Government
for the purpose of this contrnct:
ATTN: Michael W Wathen , PhD
Contracting Officer's Representative (COR)Biomedjca1 Advanced Research and Development Authority (BARDA)
Office of the Assistant Secretary for Preparedness and Response
Office of the Assistant Secretary for Preparedness and Response
Department of Health and Human Services
Mailing Address:
330 Independence Avenue, S.W.
RoomG644
Washington, D.C. 20201
202-260-8563 (work)
michael.wathen@hhs.g_ov

Alternate COR:
ATTN: Karl Erlandson,
Contracting Officer's Re presentative (COR)
Biomedical Advanced Research and Development Authority (BARDA)
Office of the Assistant Secretary for Preparedness and Response
Department of Health and Human Services

Mailing Address:
330 Independence Avenue, S.W.
RoomG644
Washington, D.C. 20201(202) 205-3608
Email: Karl.Erlandson@hhs.l!ov

The COR is responsible for:1) Monito1ing the Contractor's technical progress, including the surveilJance andassessment of performance and recommending to the Contracting Officer changes inrequirements;
2) Assisting the Conlracting Officer in interpreting the statement of work and any othertechnical performance requirements;
3) Performing technical evaluation as required;
4) Performing technical inspections and acceptances required by th is contract; and5) Assisting in the resolution of technical problems encountered during performance.
The Contracting Officer may unilaterally change its COR designation. after which it
will notify Contractor in writing of such change.
ARTICLE G.3. KEY PERSONNEL

Pursuant to the Key Personnel clause incorporated in Section I of this contract, thefollowing indi victuals are considered to be essential to the work being performed
hereunder:

The key personnel specified in this contract are considered to be essential to work
peiiormance. At least thirty (30) business days prior to dj verting any of the specified
individuals to other programs or contracts, including, where practicable, an instance when
an individual must be replaced as a res ult of leav ing the employ of the Contractor, theContractor shaH notify the Contracting Officer and shall submit comprehensive
j ustification for the diversion or replacement request (including proposed substitutions for
key personnel) to permit evaluation by the Government of the impact on performance
under this contract. The Contractor shall not divert or otherwise replace any key
personnel without the written consent of the Contracting Officer.

ARTICLE G.4. CONTRACT FINANCIAL REPORT
a. Financial reports on the anached Financial Report of Individual Project/Contract
shall be submitted by the Contractor to the CO with a copy to the COR in
accordance with the instructions for completing this form, which accompany theform, in an original and one electronic copy, not later than the 30th business day
after the close of the reporting period. The line entries for subdivisions of workand elements of cost (expenditure categories), which shaJl be repo1ied within tJ1e
total contract, are discussed in paragraph e., below. Subsequent changes and/or
additions in the line entries shall be made in writing.
b. Unless otherwise stated in the instructions for completing this form, all columns

A through J, shall be completed for each rep01t submitted.
c. The first financial report shall cover the period consisting of the first fulJ threecalendar months following the date of the contract, in addition to any fractionalpart of the initial month. Thereafter, reports will be on a quarterly basis.
d. The Contracting Officer may require the Contractor to submit detailed support
for costs contained in one or more interim financial reports. This clause does notsupersede the record retention requirements in FAR Part 4.7.
e. The listing of expenditure categories to be reported is incorporated as a part ofthis contract and can be found under SECTION J Attachment 4 entitled, "Instructions for Completing Financial Report of Individual Project/Contract''.
f.

The USG may unilaterally revise the "Financial Report of Inctividual
Project/Contract" to reflect the allotment of additional funds.

ARTICLE G.S. INVOICE/FINANCING REQUEST AND CONTRACTFINANCIAL REPORTING
Include Program Support Center (PSC) in Receipt of Invoices:Documents shall be delivered electronically to the Contracting Officer (CO), theContracting Specialist (CS), the Contracting Officer's Representative (COR) and PSC.
Unless otherwise specified by the Contracting Officer all deliverables and repo11s
furnished to the Government under the resultant contract (including invoices) shall be
addressed as follows:
Wendell Conyers
Contracting Officer
HHS/ASPRIAMCG
330 Independence Ave.,
S.W., Room G640
Washington, DC 20201
Email:
Wendell.conyers@hhs.g
ov

Okechukwu Obi
Contract Specialist
HHS/ASPRIAMCG
330 Independence Ave.,
S.W., Room 0640
Washi11gton, DC 2020 I
Email:
Okechukw u.Obi(a)hhs.g
OV

Karl Erlandson
Contracting Officer
Representative
HHS/ASPRIAMCG
330 Independence
PSC Invoices
Ave., S.W.,@psc.hhs.gov
Washington, DC
20201
Email:
Karl.Erlandson(a)hhs.
gov

a. Contractor invoices/financial rep01ts shall conform to the fonn, fonnat, andcontent requirements of the instructions for Invoice/Financing requests andContract Financial Reporting.
b. Monthly invoices must include the cumulative total expenses to date, adjusted (asapplicable) to show any amounts suspended by tbe USG.

c. The Contractor agrees to immediately notify the CO in writing if there is ananticipated overrun (any amount) or unexpended balance (greater than 10
percent) of the estimated costs for the base period or any option period(s) (Seeestimated costs under Articles B.2) and the reasons for the variance. These
requirements are in addition to the specified requirements of FAR Clause52.232-20, Limitation of Cost that is incorporated by reference under Article I.1
which states;
Limitation of Cost (Apr 1984)(a) The parties estimate that performance of this contract, exclusive of any fee,will not cost the Government more than (1) the estimated cost specified in the
Schedule or, (2) if this is a cost-sharing contract, the Government's share of theestimated cost specified in the Schedule. The Contractor agrees to use its best
efforts to perform the work specified in the Schedule and all obligations under
this contract within the estimated cost, which, if this is a cost-sharing contract,
includes both the Government's and the Contractor's share of the cost.
{b) The Contractor shall notify the Contracting Officer in writing whenever it hasreason to believe that-( 1) The costs the Contractor expects to incur under this contract in the next
60 days, when added to all costs previously incurred, will exceed 75
percent of the estimated cost specified in the Schedule; or(2) The total cost for the performance of this contract, exclusive of any fee,will be either greater or substantially less than had been previously
estimated.
(c) As part of the notification, the Contractor shall provide the Contracting Officera revised estimate of the total cost of performing this contract.
(d) Except as required by other provisions of this contract, specifically citing andstated to be an exception to this clauseThe Government is not obligated to reimburse the Contractor forcosts incurred in excess of (i) the estimated cost specified in the Scheduleor, (ii) if this is a cost-sharing contract, the estimated cost to theGovernment specified in the Schedule; and
(1)

(2)

The Contractor is not obligated to continue performance under thiscontract (including actions under the Termination clause of this contract)
or otherwise incur costs in excess of the estimated cost specified in the
Schedule, until the Contracting Officer (i) notifies the Contractor inwriting that the estimated cost has been increased and (ii) provides a revised
estimated total cost of performing this contract. If this is a cost-sharing
contract, the increase shall be allocated in accordance with the formulaspecified in the Schedule.
(e) No notice, communication, or representation in any form other than thatspecified in paragraph (d)(2) of this clause, or from any person other than theContracting Officer, shall affect this contract's estimated cost to theGovernment. In the absence of the specified notice, the Government is not
obligated to reimburse the Contractor for any costs in excess of the estimatedcost or, if this is a cost-sharing contract, for any costs in excess of the estimatedcost to the Government specified in the Schedule, whether those excess costs
were incurred during the course of the contract or as a result of termination.
(f) If the estimated cost specified in the Schedule is increased, any costs theContractor incurs before the increase that are in excess of the previously
estimated cost shall be allowable to the same extent as if incmTed afterward,
unless the Contracting Officer issues a termination or other notice directing thatthe increase is solely to cover termination or other specified expenses.
(g) Change orders shall not be considered an authorization to exceed theestimated cost to the Government specified in the Schedule, unless they containa statement increasing the estimated cost.
(h) If this contract is terminated or the estimated cost is not increased, theGovernment and the Contractor shall negotiate an equitable distribution of allproperty produced or purchased under the contract, based upon the share of costs
incurred by each.

(d) The Contractor shall submit an electronic copy of the payment request to theapproving official instead of a paper copy. The payment request shall betransmitted as an attachment via e-mail to the address listed above in one of thefollowing formats: MSWord, MS Excel, or Adobe Portable Document Format(PDF). Only one payment request shall be submitted per e-mail and the subject
line of the e-mail shall include the Contractor's name, contract number, andunique invoice number.
(e) An electronic copy of the payment request shall be uploaded into the designatedeRoom (as defined in SECTION F.3 ELECTRONIC SUBMISSION) and an email notification of the upload will be provided to the CO and COR.

(f) All invoice submissions shall be in accordance with FAR Clause 52.232-25,

Prompt Payment (Jul 2013), Alt I.
(g) Invoices - Cost and Personnel Reporting, and Variances from the Negotiated

Budget.
The Contractor agrees to provide a detailed breakdown on invoices of the following cost
categories:
a. Direct Labor - List individuals by name, title/position, hourly/annual
rate, level of effort (actual hours or% of effort), and amount claimed.
b. Fringe Benefits - Cite rate and amountc. Overhead - Cite rate and amountd. Materials & Supplies - Include detailed breakdown when total
amount is over
$1,500.
e. Travel - Identify travelers, dates, destination, purpose of trip, and total
breaking out amounts for transportation (plane, car etc), lodging,
M&IE. Cite COA, if appropriate. List separately, domestic travel,
general scientific meeting travel, and foreign travel.
f. Consultant Fees - Identify individuals, amounts and activities. Cite
appropriate COA
g. Subcontracts - Attach subcontractor invoice(s). Cite appropriate COA
h. Equipment - Cite authorization and amount. Cite appropriate COAi.
Other Direct Costs - Include detailed breakdown when total amount isover$1,500.
j. G&A - Cite rate and amount.
k. Total Cost
I. Feem. Total Cost Plus Fixed Fee
Monthly invoices must include the cumulative total expenses to date, adjusted (asapplicable) to show any amounts suspended by the USG. Nothing in this section
discharges the contractor's responsibility to comply with any applicable FAR Parts 30 or
3 Xclauses' relating to cost reimbursement subcontracts. In order to verify allowability,
further breakdown of costs may be requested at the USG's discretion. The Contractor
shall subcontract with Finn Fixed Price Contracts to the maximum extent practicable.
Additional instructions and an invoice template are provided in Attachment 3,
Invoice/Financing Request Instructions and Contract Financial Reporting Instructions for
AMCG Cost-Reimbursement Contracts. All invoices must be signed by a representativeof the contractor authorized to certify listed charges are accurate and comply with

government regulations. Invoices should be submitted electronically (in accordance withARTICLE F.3., (ELECTRONIC SUBMJSSION) Only with signature.

If applicable, the Contractor shall convert any foreign currency amount(s) in the monthly
invoice to U.S. do llars each month, on the l st of the month, using the foreign exchange
rate index published on www.federalreserve.gov. Payment of invoices is subject to the
U.S. dollar limits within the Total Estimated Cost, the Total Fixed Fee and the Total.
Estimated Cost of each active CLfN(s ) in Section B under the contract.

ARTICLE G.6. REIMBURSEMENT OF COSTl ) The Government shall reimburse the Contractor the cost determined by theContracting Officer t o be allowable (hereinafter referred to as allowable cost) inaccordance with FAR C lause 52.21 6-7, Allowable Cost and Payment incorporated byreference in Section I, Contract Clauses, of this contract. and FAR Subpart 31.2.
Examples of allowable costs include, but are not limited to, the follo wing:a) All direct materials and supplies that are used in performing the work provided
for under the contract, including those pmchased for subcontracts and pmchaseorders.
b) All direct labor, includin g supervisory, that is properly chargeable directly to thecontract, plus fringe benefits.
c) All other items of cost budgeted for and accepted in the negotiation of this basic
contract or modifications thereto.
d) Travel costs including per cLiem or actual subsistence for personnel while in an
actual travel status in direct performance of the work and services required under
this contract subject to the following:(i)

Air travel shall be by the most d irect route using coach-cl ass which
may also be referred to by airlines as "tourist class," "economy
c.lass," or as "single class'' when the airline offers onl y one class ofaccommodations to all travelers. Government and contractor
travelers are required to exercise the same care in incmring
expenses that a prudent person would exercise if traveling on
personal business when making official travel an-angements, andtherefore. should consider the least ex.pensive class of travel thatmeets their needs. You may use the lowest other than coach-classairline accommodations only when the agency specificallyauthorizes/approves such use (per the Federal Travel Regulation @http://www.gsa.gov/grapltic.s/ogp/FfR201 l -02Complete.pdt)

(ii)You must use coach-class accommodations for all train travel,
except when your agency authorizes other than coach-class service
in a written statement.

(iii)

Costs incurred for lodging, meals, and incidental expenses shall beconsidered reasonable and allowable to the extent that they do not
exceed on a daily basis the per diem rates set forth in the Federal
Travel Regulation (FfR).

(iv)

Travel via pri vateJy owned automobile shall be reimbursed at not
more than the current General Services Administration (GSA) FIR
established mileage rate.

ARTICLE G.7. INDIRECT COST RATE
The following contractor established provisional billing rates are incorporated into l'hecontract, and will be utilized for billing pm-poses during both the base and contract option
periods pending the establishment of final indirect cost rates for each fiscal year or until
revised by the contracting officer in accordance with the provisions of FAR 42. 705-1.
See FAR Clause 52.216-7.

I Rate TypeI RateI Allocation Base

I

*Moderna and the government agree to the above rates as CEILING rates for Modema's
fiscal year 2016, until new provisional billing rates a.re established for fiscal year 2017,
and th~ government will not be obligated to pay any additional amount resulting from thefinal rate exceeding the agreed-to ceiling rate as stated above. In the event the final rates
are less or greater than the ceiling rates, the agreed-to-ceiling rates will remain in place
w1til the Govemment and Moderna agree to rates negotiated by both parties. In
accordance with FAR 52.2 16-7, Moderna will submit their final indirect rates proposal
for fiscal year 2016 no later than 6 months after the end of their fiscal year.
Use of the above provisional rates does not change any cost ceilings. contract obligations,or specific allowance or disallowance prnvided for in the contract.
Contractor must notify the contracting officer promptly for an adjustment of theprovisional rates if it becomes evident that the rates would cause substantial overpayment
or underpayment of indfrect expenses to Moderna.
The final billing rates for each fiscal year will be based on the incurred cost submission
subject to Government audit determination. Indirect costs rate proposals must bes ubmitted to the cognizant agency's contracting officer within 6 months subsequent toeach of the contractor's fiscal year ends. (See also FAR Clause 52.216-?(d) (2)incorporated herein).
ARTICLE G.8. POST AW ARD EVALUATION OF CONTRACTORPERFORMANCE

1. Contractor Performance Evaluations

Interim and final evaluations of Contractor performance wi1l be prepared on thiscontract in accordance with FAR Subpart 42. 15. The final performance evaluation
will be prepared at the time of completion of work. In addition to the final evaluation,
an interim evaluation shall be submitted annually.
Interim and final evaluations will be provided to the Contractor as soon as practicable
after completion of the evaluation. The Contractor will be pe1mitted fourteen calendar
to review the document and to submit additional infomiation or a rebutting statement.
If agreement cannot be reached between the parties, the matter will be referred to anindividual one level above the Contracting Officer whose dec ision will be final.
Copies of the evaluations, Contractor responses, and review comments, if any, will be
retained as part of the contract file, and may be used to support future award
decisions.
2. Electronic Access to Contractor Perfo1·mance Evaluations

Contractors that have Internet capability may access evaluations through a secure
Web site for review and comment by completing the registration form that can beobtained at the following address:
http://www.cpars.csd.disa.mil/cgarsmain.htm
The registration process r equires the Contractor to identify an individual that willserve as a primary contact and who will be authorized access to the evaluation forreview and comment. In addition, the Contractor will be required to identify analternate contact that will be responsible for notifying the cognizant contracting
official in the event the primary contact is unavailable to process the evaluation
witl1in the required 30-day time frame.

ARTICLE G.9. CONTRACT COMMUNICATIONS/CORRESPONDENCE

The Contractor shall identify all correspondence, reports. and other data pertinent tothis contract by imprinting the contract number from Page l of the contract.
ARTICLE G.10. GOVERNMENT PROPERTYNIAARTICLE G.11. EXERCISE OF OPTIONS
Unless the Government exercises its option pursuant to the Option Clause set forth in
Section I, Article 1.2, the contract will consist only of CUN 0001 of the Statement ofWork, Deliverables and Requirements as defined in Sections C, F and J of thecontract. Pursuant to FAR Clause 52.217-9 (Option to Extend the Term of theContract) set forth in Section I of this contract, under Article 1.2, the Government
may, by unilateral contract modification, require the Contractor to perform theadditional CLINs listed in Section B, Article B.3., and as also defined in Sections C,
F and J of this contract. If the Government exercises an option, written notice mustbe given to the Contractor within 30 days after the Government has completed its
analysis of the deliverables associated with the applicable in-process programmatic
review; and the Government must give the Contractor a preliminary written notice of
its intent to exercise the option at least 30 days before the contract expires. The
amount obligated to the contract and total estimated cost may then be increased as set
forth in Section B, Article B.3 provided that Government funds are available.

SECTION ff-SPECIAL CONTRACT REQUIREMENTS
The Contractor, depending upon the nature of the work, is responsible for following theprovisions below in conducting its own work under this contract. The Contractor also is
responsible for incorporating these provisions into any subcontract awarded, if applicableto the specific nature of the work in the subcontract. Accordingly, those provisions shallbe flowed-down as applicable.

ARTICLE H.1 CLINICAL AND NON-CLINICAL TERMS OF AWARD
BARDA has a responsibility to obtain documentation concerning mechanisms andprocedures that are in place to protect the safety of participants and animals in BARDA
funded clinical trials and non-clinical studies. Therefore, the Contractor shall develop a
protocol for each clinical trial and non-clinical study funded under this contract andsubmit all such protocols and protocol amendments to the Contracting Officer 's
Representative (COR) for evaluation and comment.
Approval by the COR is required before work under a protocol may beg in. The COR
comments will be forwarded to the Contractor within eight (8) business days. The
Contractor must address, in writing, all concerns (e.g. study design, safety, regulatory,
ethical, and conflict of interest) noted by the COR.
If the draft protocols are to be submitted to the FDA, COR review shall occur before
submission, pursuant to the terms set forth by ARTICLE F.2 of this contract. The
Contractor shall consider revising their protocols to address COR's concerns andrecommendations prior to FDA subm ission. The Contractor must provide COR with acopy of FDA submissions, within the time frame set forth by ARTICLE F.2 of thiscontract.
Execution of clinical and non-clinical s tudies requires written authorization from theGovernment. The USG will provide written authorization to the Contractor upon either 1)
receiving documentation in which all COR comments have been satisfactorily addressed;or 2) receiving documentation that the FDA has reviewed and commented on the
protocol.
The Government shall have rights to all protocols, data 1·esulting from execution of these
protocols, and final repmts fimded by BARDA under this contract, as set forth in the FAR
clauses referenced in PART II of this contract. The Government reserves the right torequest tbat the Contractor provide any contract deliverable in an unredacted fom1 toensure the Government has the abi Lity to review and distribute the deliverables.
Important information regarding performing human subject research is available at
http://www3 .niaid.nih.gov/hea lthscience/clinicalstudies/
https://hutnansubjects.nih.gov/
Any updates to technical repo1is are to be addressed in the Monthly and Annual Progress
Reports. The Contractor shall advise the Contracting Officer's Representative or designee
in writing and via electronic communication in a timely manner of any issues potentiallyaffecting contract perfonnance.

1. Non-Clinical Terms of Award
These Non-Clinical Terms of Award detail an agreement between the Biomedical
Advanced Research and Development Authority (BARDA) and the Conh·actor;
they apply to all grants and contracts that involve non-clinical research.

a. Safety and Monitoring Issues
i. PHS Policy on Humane Care and use of Laboratory Animals

Before award and then with the annual progress report, the Contractor
must submit to the COR a copy of the current Institutional Animal Careand Use Committees ([ACUC) documentation of continuing review
and approval and the Office ofLaboratory Animal Welfare (OLAW)
federal wide assurance number for the institution or site.

lf other institutions are involved in the research (e.g., a multicenter trial
or study), each institution's IACUC must review and approve theprotocol.
They must also provide COR initial and annual documentation ofcontinuing review and approval and federal wide assurance number.

The Contractor must ensure that the application, as well as all protocols,
are reviewed by the perfonning institution's IACUC.
To help ensure the safety of animals used in BARDA-funded studies,
the Contractor must provide COR copies of documents related to all
major changes in the status of ongoing protocols, including thefollowing:•

All amendments or changes to the protocol, identified byprotocol version number, date, or both and date it is valid.

•

All material changes in IACUC policies and procedures,
identified by version number, date, and all required signatories(if applicable).

•

Termination or temporary suspension of the study(ies) for
regulatory issues.

•

Termination or temporary suspension of the protocol.

•

Any change that is made in the specific IACUC approval forthe indicated study(ies).

•

Any other problems or issues that could affect the scientificintegrity of the study(ies), i.e., fraud, misrepresentation,
misappropriation of funds, etc.

Contractor must notify COR of any of the above changes w ithin five (5)working days from the time the Contractor becomes aware of suchchanges by email or fax, followed by a letter signed by the institutional
business official, detailing notification of the change of status to the
local IACUC and a copy of any responses from the IACUC.
If a non-clinical protocol has been reviewed by an institutional
biosafety committee (IBC) or the NIH Recombinant DNA Advisory
Committee (RAC), the Contractor must provide information about theinitial and ongoing review and approval, if any. See the NIH
Guidelines for Research Involving Recombinant DNA Molecules.
ii. Non-Clinical Data and Safety Monitoring Requirements

The Government strongly recommends continued safety monitoring for
all non- clinical studies of investigational drugs, devices, or biologics.
FDA expects non-clinical studies to include safety in addition toefficacy. The Contractor should consider evaluation of clinical relevant
safety markers in the pivotal and non-pivotal, non-clinical studies. Inpreparation for clinical trials of licensed or not yet licensed products, it
is imperative that BARDA- sponsored studies of any type measure therisk and safety parameters that are elicited and provide a safety profile
from the studies for future human risk assessment.
A risk is minimal where the probability and magnitude of harm or
discomfort anticipated in the proposed research are not greater thanthose ordinarily encountered in daily life or during the performance ofroutine physical or psychological examinations or tests. For example,
the risk of drawing a small amount of blood from a healthy subject for
research purposes is no greater than the risk of doing so as part of aroutine physical examination (45 CFR 46. l 02(i)).
BARDA will work with the Contractor on decisions regarding the typeand extent of safety data accrual to be employed before the start ofefficacy or safety studies.
The Contractor shall inform COR of any upcoming site visits and/or
audits of CRO facilities funded under this effo1t. The Government
reserves the right to accompany the Contractor on site visits and/or
audits ofCRO's as CO R deems necessary.
b. BARDA Review Process before Non-Clinical study Execution Begins
BARDA is under the same policy-driven assurances as NIH in that it has a
responsibility to ensure that mechanisms and procedures are in place to protect
the safety and welfare of animals used in BARDA-funded non-clinical trials.
Therefore, before study execution, the Contractor must provide the following(as applicable) for review and comment by COR:
• IACUC approved (signed) non-clinical research protocol identified byversion number, date, or both, including details of study design,euthanasia criteria, proposed interventions, and exclusion criteria.
• For non-pivotal mouse studies, the Contractor will provide an annual
animal care and use protocol.
• Documentation ofIACUC approval, including OLAW federal wide
number, IACUC registration number, and IACUC name .
• Contractor should reduce the number of animals required for a study
using statistical power.
• Plans for the management of side effects, rules for interventions andeuthanasia criteria.

• Procedures for assessing and collecting safety data.

• If a study is contracted through Contract Research Organizations (CROs),
work orders and service agreements the Contractor shall assure an
integrated safety documentation plan is in place for tbe study site,
pharmacy service records on the dosing material to be used andexcipients, and laboratory services (including histopathology) .
• Docmnentation that the Contractor and all required staff responsible fortbe conduct of the research have received training in tbe protection andhandling of animals, or that the CRO bas the required documentation.
• Purchasing of animals and/or other supplies for non-clinical studies
funded in part or in whole by BARDA requires written approval by theContracting Officer in accordance with the contract. The Contractor musthave the ability to return/re-sell animals, at purchase price, to distributor
or a third part, in the event that the Contracting Officer Authorization is
not granted.
• Provide justification for whether studies require good laboratory practice(GLP) conditions .
• Provide j1tstification for whether studies will be classified as non-pivotal
or pivotal studies.
Documentation of each of the above items shall be submitted to COR for
evaluation and comment in conj unction with the protocol. Execution of nonclinical studies requires written authorization from the Contracting Officer inaccordance with this section of the contract.

c. References
Public Health Service Policy on Humane Care and Use of Laboratory Animals:
http://grants.nih.gov/g:rants/o1aw/InvestigatorsNeed2Know.pdf
USDA Animal Welfare Act:
https://www.aphis.usda.gov/aphis/ourfocus/animalwelfare/sa awa/ct awa program infor
mation/! ut/p/z l/tVJNc4IwEP0tPXhkNnwoeARLxY60UxX5uGTCd l oiiCi1 v75BD51pp1
IPzWVnk337dt8LBOBBwMiRZgSIFSMFz l ggpfPykw0 1ohH00C6uVJt01xISFXAvVo
gyhDcht9aE 16wcTZPmmgsptLf8OiXo61\1.b BYCCCLW 1m0OPglzusclRxdgEtbig YUOa
0wjtCa4ODU6r6LA Z4TRkhS4S4q UNMnlgiMjFLV9xHVTZO0pMWVp l ZRnKXuWO
glx-GM5 1FAspYico6mgxloihKEaCbGcSJI8TcVIJgOg8rGD60u7PdAL98Kfgo ROLzidWvDvP7QPSHVG0xrYpJ2UM7 pEmHTisF6GA9Y0aW Ageh9zj35O-

7naBzj3sXXtvwftHEzrndlNgzO-OLkDYXjfwLkDwrgD5IllRhVw F 1 wBf6Xbpiw5 l 6ThOqckn4W21dZs0LA5L62Nx9wkRTbTc/d z/d5/L2dBISEvZ0FBIS9nOSEh/?w-ile=wcm%3Apath%3A%2Faphis content Iibrary%2Fsa
our focus%2Fsa animal welfare%2Fsa awa%2Fct awa program information

2. Clinical Terms of Award
These C linical Tem1s of Award detail an agreement between the Government and theContractor; they apply to all grants and contracts that involve clinical research.
Draft protocols for each cljnical study will be submitted to COR for evaluation andcomment. COR comments will be addressed and/or incorporated into the draft protocol
prior to submission to the FDA for comment, if required.
The Government shall have unlimited rights to all protocols, data generated from theexecution of these protocols, and final reports, funded by BARDA under this contract, as
defined in Rights in Data Clause in FAR 52.227-14, Alternate II. The Government
reserves the right to request that the Contractor provide any contract deliverable in an
Lutredacted form to ensure the COR has the ability to review and distribute thedeliverables, as COR deems necessa1ya. Safety and Monitoring Issuesi.

Institutional Review Board or Independent Ethics Committee
Approval
Before award and then with the annual progress report, the Contractor
must submit to the COR a copy of the current IRB-or !EC-approved
informed consent document, documentation of continuing review andapproval and the OHRP federal wide assurance number for the institution
or site.

If other institutions are involved in the research ( e.g., a multicenter clinical
trial or study), each institution's lRB or IEC must review and approve theprotocol. They must also provide the COR initial and annual
documentation of continuing review and approval, including the current
approved informed consent document and federal wide number.
The Contractor must ensure that the application as well as all protocols arereviewed by their IRB or IEC.
To help ensure the safety of partic ipants enrolled in BARDA-fundedstudies, the Conh·actor must provide COR copies of documents related to
all major changes in the status of ongoing protocols, including thefollowing:•All amendments or changes to the protocol, identified by protocol
version number, date, or both and dates it is valid.

•

All changes in informed consent documents, identified by version
number, dates, or both and dates it is valid.

•

Termination or temporary suspension of patient accrual.

•

Termination or temporary suspension of the protocol.

•

Any change in IRB approval.

•

Any other problems or issues that could affect the participants in thestudies.

The Contractor must notify the Government through the COR and CO of anyof the above changes within five (5) working days electronically, followed bya letter signed by the institutional business official, detailing notification of
the change of status to the local IRB and a copy of any responses from the
IRB or IEC.
If a clinical protocol has been reviewed by an institutional biosafetycommittee (IBC) or the NIH Recombinant DNA Advisory Committee (RAC),
the Contractor must provide information about the initial and ongoing review
and approval, if
any. See the NIH Guidelines for Research Involving Recombinant DNA
Molecules.
ii.

Data and Safety Monitoring Requirements
The Government strongly recommends independent safety monitoring forclinical trials of investigational drugs, devices, or biologics; clinical trial oflicensed products; and clinical research of any type involving more thanminimal risk to volunteers.
Independent monitoring can take a variety of forms. Phase III clinical trials
must be reviewed by an independent data and safety monitoring board(DSMB); other trials may require DSMB oversight as well. The Contractor
shall inform the COR of any upcoming site visits and/or audits of CRO
facilities funded under this effort.
The Government reserves the right to accompany the Contractor on site visits
and/or audits of CROs as COR deems necessary.
A risk is minimal where the probability and magnitude of harm or discomfort
anticipated in the proposed research and not greater than those ordinarily
encountered in daily life or during the performance of routine physical orpsychological examinations or tests. For examples, the risk of drawing asmall amount of blood from a healthy individual for research purposes is no
greater than the risk of doing so as part of a routine physical examination (45CFR 46.102(i)).
Final decisions regarding the type of monitoring to be used must be madejointly by the Government and the Contractor before enrollment staits.
Discussions with the responsible Contracting Officer's Representative
regarding appropriate safety monitoring and approval of the final monitoringplan by the COR must occur before patient enrollment begins and may
include discussions about the appointment of one of the following ..
BARDA will have one non-voting observer as a representative on any Dataand Safety Monitoring board or other similar oversight board.
■

Independent Safety Monitor - a physician or other appropriate
expert who is independent of the study and available in real time toreview and recommend appropriate action regarding adverse eventsand other safety issues.

■

Independent Monitoring Committee (IMC) or Safety Monitoring
Committee (SMC) - a small group of independent investigators andbiostatisticians who review data from a particular study.

■

Data and Safety Monitoring Board - an independent committee
charged with reviewing safety and trial progress and providing advice
with respect to study continuation, modification, and termination. The
Contractor may be required to use an established BARDA DSMB or
to organize an independent DSMB. All phase III clin ical trials must
be reviewed by a DSMB; other trials may require DSMB oversight aswell. Please refer to: NIAID Principles for Use of a Data and Safety
Monitoring Board (DSMB) For Oversight of Clinical Trials Policy

When a monitor or monitoring board is organized, a description of it, its
charter or operating procedures (including a proposed meeting schedule andplan for review of adverse events), and roster and curriculum vitae from all
members must be submitted to and approved by the COR before enrollment
starts. The Contractor will also ensure that the monitors and board members
report any conflicts of interest and the Contractor will maintain a record ofthis. The Contractor will share conflict of interest reports with COR and CO.
Additionally, the Contractor must submit written summaries of all reviews
conducted by the monitoring group to the COR within thirty (30) days ofreviews or meetings.
iii. BARDA Protocol Review Process Before Patient Enrollment Begins

The Government has a responsibility to ensure that mechanisms andprocedures are in place to protect the safety of participants in BARDA-supported clinical trials. Therefore, before patient accrual or participant
enrollment, the Contractor must ensure the following (as applicable) are inplace at each participating institution, prior to patient accrual orenrollment:•

IRB- or !EC-approved clinical research protocol identified by version
number, date, or both, including details of study design, proposedinterventions, patient eligibility, and exclusion criteria.
• Documentation ofIRB or IEC approval, including OHRP federal
wide number, IRB or IEC registration number, and IRB and IEC
name.
• IRB- or IEC- approved informed consent document, identified byversion number, date, or both and dates it is valid.
• Plans for the management of side effects.
• Procedures for assessing and reporting adverse events.
• Plans for data and safety monitoring (see above) and monitoring of
the clinical study site, pharmacy, and laboratory.
• Documentation that the Contractor and all study staff responsible forthe design or conduct of the research have received training in theprotection of human subjects.
Documentation to demonstrate that each of the above items are in place shallbe submitted to the COR) for evaluation and comment in conjunction withthe protocol. Execution of clinical studies requires written authorization fromthe COR in accordance with this section of this contract.
iv.

Investigational New drug or Investigational Device Exemption
Requirements

Consistent with federal regulations, clinical research projects involving theuse of investigational therapeutics, vaccines, or other medical interventions(including licensed products and devices for a purpose other than that for
which they were licensed) in humans under a research protocol must be
performed under a Food and Drug Administration (FDA) investigational
new drug (IND) or investigational device exemption (IDE).
Exceptions must be granted in writing by FDA. If the proposed clinical trial
will be performed under an IND or IDE, the Contractor must provide the
COR with the name and institution of the IND or IDE sponsor, the date theIND or IDE was filed with FDA, the FDA IND or IDE number, any writtencomments from FDA, and the written responses to those comments.
Unless FDA notifies Contractor otherwise, The Contractor must wait thirty(30) calendar days from FDA receipt of an initial IND or IDE application
before initiating a clinical trial.
The Contractor must notify the COR if the FDA places the study on clinicalhold and provide the COR any written comments from FDA, writtenresponses to the comments, and documentation in writing that the hold has
been lifted. The Contractor must not use grant or contract funds during aclinical hold to fund clinical studies that are on hold. The Contractor must
not enter into any new financial obligations related to clinical activities forthe clinical ttial on clinical hold.

v. Required Time-Sensitive Notification
Under an IND or IDE, the sponsor must provide FDA safety reports ofserious adverse events. Under these Clinical Terms of Award, the Contractor
must submit copies to the responsible Contracting Officer's Representative(COR) as follows:i. Expedited safety report of unexpected or life-threatening experienceor death:
A copy of any report of unexpected or life-threatening experience ordeath associated with the use of an IND drug, which must bereported to FDA by telephone or fax as soon as possible but no later
than seven (7) days after the IND sponsor's receipt of theinformation, must be submitted to the COR within 24 hours of FDA
notification.
ii. Expedited safety reports of serious and unexpected adverse

expenences:
A copy of any report of unexpected and serious adverse experience
associated with use of an IND drug or any finding from tests inlaboratory animals that suggests a significant risk for humansubjects, which must be reported in writing to FDA as soon as
possible but no later than 15 day after the IND sponsor 's receipt of
the information, must be submitted to the COR within 24 hours of
FDA notification.
iii. IDE reports of unanticipated adverse device effect:

A copy of any reports of unanticipated adverse device effectsubmitted to FDA must be submitted to the COR within 24 hours of
FDA notification.
iv. Expedited safety reports:
Sent to the COR concurrently with the report to FDA.
v. Other adverse events documented during the course of the trial should
be included in the annual IND or IDE report and reported to the COR
annually.

In case of problems or issues, the Contracting Officer's
Representative wiJl contact the Contractor within ten (10) working
days by email or fax, followed within thirty (30) calendar days by an
official letter to the Contractor's Project Manager, with a copy to theinstitutions' office of sponsored programs, listing issues andappropriate actions to be discussed

vi. Safety repo1iing for research not perfonned under an IND or IDE.
Final decisions regarding ongoing safety repo1iing requirements forresearch not performed under an IND or IDE must be made jointly
by the Contracting Officer's Representative and the Contractor.

ARTICLE H.2. PROTECTION OF HUMAN SUBJECTS, HHSAR 352.270-4(b)(December 18, 2015)
a. The Contractor agrees that the rights and welfare of human subjects involved in researchunder this contract shall be protected in accordance with 45 CPR Part 46 and with theContractor's current Federal-wide Assurance (FWA) on file w ith the Office for Human
Research Protections (OHRP), Department of Health and Human Services. The
Contractor further agrees to provide certification at least annually that the Institutional
Review Board has reviewed and approved the procedures, which involve human su~jects
in accordance with 45 CFR Part 46 and the Assurance of Complianceb. The Contractor shall bear full responsibility for the performance of all work and services

involving the use of human subjects under this contract and shat I ensure that work is
conducted in a proper manner and as safely as is feasible. The paities hereto a&,ree that theContractor retains the right to control and cfuect tbe performance of all work under thiscontract. Nothing in this contract shall create an agency or employee relationship between
the Government and the Contractor, or any subconh·actor, agent or employee of theContractor, or any other per:son, organization, institution, or group of any kindwhatsoever. The Contractor agrees that it has entered into this contract and will discharge
its obligations, duties, and undettakings and the work pursuant thereto, whether requiring
professional judgment or otherwise, as an independent Contractor without creating
liability on the part of the Government for the acts of the Conh·actor or its employees.
c. Contractors involving other agencies or institutions in activities considered to be engaged
in research involving human subjects must ensure that such other agencies or institutions
obtain their own FWA if they a.re routinely engaged in research involving hwnan subjects
or ensure that such agencies or institutions are covered by the Contractors' FWA via
designation as agents of the institution or via individual investigator agreements (seeOHRP website at: http://www.hhs.gov/ohrp/policy/guidanceona1temativetofwa.pdt).
d. If at any time during the performance of this contract the Contractor is not in compliancewith any of the requirements and or standards stated in paragraphs (a) and (b) above, theContracting Officer may immediately suspend, in whole or in part work and further

payments under this contract until the Contractor corrects the noncompliance. The
Contracting Officer may communicate the notice of suspension by telephone withconfirmation in writing. If the Contractor fails to complete cou ective action within the
period of time designated in the Contracting Officer's written notice of suspension, theContracting Officer may, after consultation with OHRP, te11ninate this contract in whole
or in part.

ARTICLE H.3. HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE)The acquisition and supply of all human specimen material {including fetal material) usedtmder this contract shall be obtained by the Contractor in foll compl iance with applicableFederal, State and Local laws and the provisions of the Uniform Anatomical Gift Act in the
United States, and no undue inducements, monetary or otherwise, w ill be offered to any
person to influence their donation of human material.
The Contractor shall provide written documentation that all human materials ob tained as aresult of research involving human subjects conducted under this contract, bycollaborating sites, or by subcontractors identified under this contract, were obtained withprior approval by the Office for Human Research Protections (OHRP) of an Assw-ance tocomplywith the requirements of 45 CFR 46 to protect human research subjects. This
restriction applies to all collaborating sites without OHRP- approved Assurances, whether
domestic or foreign , and compliance must be ensured by the Contractor.
Provision by the Contractor to the Contracting Officer of a properly completed "ProtectionofHuman Subjects Assurance Identification/IRB Certification/Declaration of
Exemption", Form 0MB No. 0990-0263(formerly Optional Fonn 310), certifying IRB
review and approval of the protocol from which the hw11an materials were obtained
constitutes the written documentation required. The human subject ce11ification can be met
by submission of a self-designated form provided that it contains the information requiredby the ''Protection of Hrunan S11bjects Assurance ldentification/IRB
Certification/Declaration of Exemption", Form 0MB No. 0990-0263 (formerly Optional
Fonn 310).

ARTICLE H.4. RESEARCH INVOLVING HUMAN FETAL TISSUE
All research involv ing human fetal tissue shall be conducted in accordance with the Public
Health Service Act, 42 U.S.C. 289g- l and 289g-2. Implementing regulations and guidancefor conducting research on human fetal tissue may be found at 45 CFR 46, Subpart Band
http://grants l .nih.go v/grants/ guide/notice-files/not93-23 5.html and any subsequent
revisions to this NIH Guide to Grants and Contracts ("Guide") Notice.
The Contractor shall make avai lable, for audit by the Secretar y, HHS, the physician
statements and informed consents required by 42 USC 289g- l (b) and (c ), or ensure HHS
access to those records, if maintained by an entity other than tbe Contractor.

ARTICLE H.5. CARE OF LIVE VERTEBRATE ANIMALS, HHSAR 352.270-Sb(December 18, 2015)
a. Before undertaking performance of any contract involving animal-related activities where
the species is regulated by USDA, the Contractor sha ll register with the Secretary ofAgriculn1re of the United States in accordance with 7 U.S.C. 2136 and 9 CFR sections
2.25 through 2.28. The Contractor shall furnish evidence of the registration to theContracting Officer.
b. T he Contractor shall acquire ve1i ebrate animals used in research from a dealer licensed
by the Secretary of Agriculture under 7 U.S.C. 2133 and 9 CFR Sections 2. 1-2.11 , orfrom a source that is exempt from licensing under those sections.
c. l11e Contractor agrees that the care, use and intended use of any live ve1tebrate animals
in the perfom1ance of this contract shall conform with the Public Health Service (PHS)
Policy on Humane Care of Use of Laboratory Animals (PHS Policy), the cun-ent
Animal. Welfare Assurance (Assurance), the Guide for the Care and Use of Laboratory
Animals (National Academy Press, Washington, DC) and the pertinent laws andregulations of the United States Department of Agriculture (see 7 U.S.C. 2131 et seq.
and 9 CFR Chapter I, Subchapter A, Parts 1-4 ). In case of conflict between standards, themore stringent standard shall govern.
d. If at any time during performance of this contract, the Contracting Officer determines, inconsultation with the Office of Laboratory Animal Welfare (OLAW), National Institutesof Health (NIH), that the Contractor is not in compliance with any of the requirements
and standards stated in paragraphs ( a) through ( c) above, the Contracting Officer may
immediately suspend, in whole or in part, work and fiuiher payments under this contract
until the Contractor corrects the noncompliance. Notice of the suspension may be
communicated by telephone and confirmed in writing. If the Contractor fai ls to complete
corrective action within the period of time designated in the Contracting Officer's
written notice of suspension, the Contracting Officer may, in consultation with OLAW,
NIH, terminate this contract in whole or in part, and the Contractor's name may beremoved from the list of those contractors with approvedAssmances.
Note: The Contractor m ay reguest registration of its facility and a CLment listing oflicensed dealers from the Regional Office of the Animal and Plant Health Inspection
Service (APHIS ), USDA, for the region in which its research faci lity is located. The
location of the appropriate APHIS Regional Office, as well as information concerning thisprogram may be obtained by contacting the Animal Care Staff, USDA/APHIS, 4700 River
Road, Riverdale, Maryland 20737 (E-m ail: ace@aph is.usda.gov; Web site:(http://www.aphis.usda.gov/ani.mal welfare).

ARTICLE H.6. ANIMAL WELFARE

All research involving live, ve1tebrate animals shall be conducted in accordance with the
Public Health Service Policy on Humane Care and Use of Laboratory Animals. l11is policy
may be accessed at:
httpJ/grantsl.nih.gov/grants/olaw/references/phspol.hun

ARTICLE H.7. INFORMATION ON COMPLIANCE WITH ANIMAL CARE
REQIBREMENTS
Registration witb tbe U. S. Dept. of Agriculture (USDA) is required to use regulated
species of animals for biomedical purposes. USDA is responsible for the enforcement of
the Animal WelfaJe Act (7 U.S.C. 213 1 et. seq.), https://awic.nal.usda.gov/
The Public Health Service (PHS) Policy is administered by the Office of Laboratory
Animal Welfare (OLAW) http://grants2.nili.gov/grants/olaw/olaw.htm. An essential
requirement of the PHS Policy http://grants2.nih.gov/grants/olaw/references/phspol.htm
is that every institution using live vertebrate anima ls must obtain an approved assurance
from OLAW before they can receive funding from any component of the U.S. Public
Health Service.
The PHS Policy requires that Assured institutions base their programs of animal care anduse on the Guide for the Care and Use of Laboratory Animals
http://www.nap.edu/readingroom/books/labrats/ and that they comply with the regulations(9 CFR, ChapterLSubchapter A) https://awic.nal.usda.gov/final-rules-animal~welfare-9~
cfr-parts-1-2-and-3
issued by the U.S. Department of Agriculture (USDA) under the Animal Welfare Act. The
Guide may differ from USDA regulations in some respects. Compliance with the USDA
regulations is an absolute requirement of this Policy.
The Association for Assessment and Accreditation of Laboratory Animal Care
International (AAALAC) http://www.aaalac.org/ is a professional organization that
inspects and evaluates programs of animal care for institutions at their request. Those tbat
meet the high standards are given the accredited status. As of the 2002 revision of the
PHS Policy, the only accred iting body recognized by PHS is the AAALAC. While
AAALAC Accreditation is not requiJed to conduct biomedical research, it is highly
desirable. AAALAC uses the Guide as their primary evaluation tool. They also use the
Guide for the Care and Use of Agricultural Animals in Agricultural Research andTeaching. It is published by the Federated of Animal Science Societies
http://www.fass.org/.

ARTICLE H.8. Notice to Offerors of Requirement for Compliance with the Public
Health Service Policy on Humane Care and Use of Laboratory Animals (January
2006)
The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory
Animals (PHS Policy) establishes a number of requirements for research activities

involving animals. Before award may be made to an applicant organization, theorganization shall file, with tbe Office of Laboratory Animal Welfare (OLAW), National
Institutes of Health (Nil-1), a written Animal Welfare Assurance (Assmance) which
commits the organization to comply with the provisions of the PHS Policy, the Animal
W elfare Act, and the Guide for the Care and Use of Laboratory Animals (National
Academy Press, Washington, DC). In accordance with the PHS Po1icy, applicant
organizations must establish an Institutional Animal Care & Use Committee (IACUC),
qualified through the experience and expe11ise of its members, to oversee the institution's
animal program, facilities and procedures. Applicant organizations are required toprovide verification of IACUC approval ptior to re]ease of an award involving live
ve11.ebrate animals. No award involving the use of animals shall be made unless OLAW
approves the Assurance and verification of IACUC approval for the proposed animal
activities has been provided to the Contracting Officer. Prior to award. the Contracting
Officer will notify Contractor(s) selected for projects that involve live vertebrate animals
that an Assmance and verification of IACUC approval are required. The Contracting
Officer will request that OLAW negotiate an acceptable Assurance with thoseContractor(s) and request verification of IACUC approval. For fwther information,
contact OLAW at NIH, 6705 Rockledge Drive. RKLl, Suite 360, MSC 7982 Bethesda.
Maryland 20892-7982 (E-mail: olaw@od.nih.gov; Phone: 301 -496- 7 163).
No PHS supported work for research involving vertebrate animals will be conducted by anorganization, unless that organization is operating in accordance with an approved Animal
Welfare Assurance and provides verification that the Institutional Aninrnl Care and Use
Committee (IACUC) has reviewed and approved the proposed activity in accordance with
the PHS policy. Applications may be referred by the PHS back to the institution forfurther review in the case of apparent or potential violations of the PHS Policy. No award
to an individual wi ll be made unless that individual is affil.iated with an assuredorganization that accepts responsibility for compliance wi th the PHS Policy. Foreign
applicant organizations applying for PHS awards for activities involving ve11ebrate
animals are required to comply with PHS Policy or provide evidence that acceptable
standards for the humane care and use of animals will be met. Foreign applicant
organizations are not required to submit IACUC approval, but should provide infonnationthat is satisfactory to the USG to provide assurances for the humane care of such animals.
ARTICLE H.9. APPROVAL OF REQUIRED ASSURANCE BY OLA W

Under governing regu lations, federa l ftmds which are admi11istered by the Depai1ment of
Health and Human Services, Office of Biomedical Advanced Research and Development
Authority (BARDA) shall not be expended by the Contractor for research involving live
vertebrate animals, nor shall live ve11ebrate animals be involved in research activities by
the Contractor w1der this award unless a satisfactory assurance of compliance with 7
U.S.C. 2136 and 9 CFR Sections 2.25-2.27 is submitted within 30 days of the date ofthi saward and approved by the Office of Laboratory Animal Welfare (OLAW) . Each
performance site (if any) must also assure compliance w ith 7 U.S.C. 2 136 and 9 CFR
Sections 2.25-2.27 with the following restriction: Only activities which do not directly
involve live vertebrate animals (.i.e. are clearly severable and independent from thoseactivities that do involve li ve vertebrate animals) may be conducted by the Contractor orindividual perfonnance sites pending OLAW approval of their respective assurance ofcompliance with 7 U.S.C. 2136 and 9 CFR Sections 2.25-2.27. Additional information
regarding OLAW may be obtained via the Internet at
http://grants2.nih.gov/grants/olaw/references/phspol.htm

ARTICLE H.10. REPORTING MATTERS INVOLVING FRAUD, WASTE AND
ABUSE
Anyone who becomes aware of the existence or apparent existence of fraud, waste andabuse in BARDA ftmded programs should report such matters to the HHS Inspector
General's Office in wtiting or on the Inspector General's Hotline. The toll free number is
l-800- HHS-TIPS ( l-800- 447-8477). All telephone calls will be handled confidentially.
The e-mail address is Htips@os.dhhs.gov and the mailing address is:
Office of Inspector General
Department of Health and Human Services
TIPS HOTLINE
P.O. Box 23489 Washington, D.C. 20026

ARTICLE H.11. PROHIBITION ON CONTRACTOR INVOLVEMENT WITHTERRORIST ACTIVITIESThe Contractor acknowledges that U.S. Executive Orders and Laws, including but notlimited toE.O. 13224 and P.L. 107-56, prohibit transactions with, and the provision ofresources
and support to, individuals and organizations associated with teITorism. It is the legal
responsibility of the Contractor to ensure compliance with these Executive Orders andLaws. This clause must be included in all subcontracts issued under this contract.

ARTICLE H.12. IDENTIFICATION AND DISPOSITION OF DATAThe Contractor wi ll be required to provide certain data generated under this contract to the
Department of Health and Human Services (DHHS). DHHS reserves the right to review
any other data detennined by DHHS to be relevant to this contract in accordance with
FAR 52.227-14, A lternate II. The Contractor shall keep copies of all data required by the
Food and Drug Administration (FDA) relevant to this contract for the time specified by
the FDA.

ARTICLE H.13. EXPORT CONTROL NOTIFICATION
Contractors are responsible for ensuring compliance with all expo11 control laws andregulations that may be applicable to the export of and foreign access to their proposed
technologies.
Contractors may consult with the Department of State with any questions regarding theInternational Traffic in Arms Regulation (!TAR) (22 C.F.R. Parts 120-130) and /or theDepartment of Commerce regarding the Export Administration Regulations ( 15 C.F.R.
Parts 730-774).

ARTICLE H.14. CONFLICT OF INTEREST
The Contractor represents and warrants that, to the best of the Contractor's knowledge andbelief, there are no relevant facts or circumstances which could give rise to anorganizational conflict of interest, as defined in FAR 2.101 and Subpart 9.5, or that theContractor has disclosed all such relevant information. Prior to commencement of any
work, the Contractor agrees to notify the Contracting Officer promptly that, to the best of
its knowledge and belief, no actual or potential conflict of interest exists or to identify to
the Contracting Officer any actual or potential conflict of interest the fom may have. In
emergency situations, however, work may begin but notification shall be made within five(5) working days. The Contractor agrees that if an actual or potential organizational
conflict of interest is identified during performance, the Contractor shall promptly make afull disclosure in writing to the Contracting Officer. This disclosure shall include a
description of actions which the Contractor has taken or proposes to take, after
consultation with the Contracting Officer, to avoid, mitigate, or neutralize the actual or
potential conflict of interest. The Contractor shall continue perfonnance until notified by
the Contracting Officer of any contrary action to be taken. Remedies include terminationof this contract for convenience, in whole or in part, if the Contracting Officer deems
such termination necessary to avoid an organizational conflict of interest. If theContractor was aware of a potential organizational conflict of interest prior to award or
discovered an actual or potential conflict after award and did not disclose it ormisrepresented relevant information to the Contracting Officer, the USG may te1minate thecontract for default, debar the Contractor from USG contracting, or pursue such otherremedies as may be permitted by law or this contract.

ARTICLE H.15. INSTITUTIONAL RESPONSIBILITY REGARDINGINVESTIGATOR FINANCIAL CONFLICTS OF INTEREST
The Contractor shall comply with the requirements of 45 CFR Part 94, Responsible
Prospective Contractors, which promotes objectivity in research by establishing standards
to ensure that Investigators (defined as the project director or principal Investigator andany other person, regardless of title or position, who is responsible for the design,
conduct, or reporting of research funded under BARDA contracts, or proposed for suchfunding, which m ay include, for example, collaborators or consultants) will not be biased
by any Investigator financial conflicts of interest.
If the failure of an Investigator to comply with an Institution's financial conflicts of interest
policy or a financial conflict of interest management plan appears to have biased thedesign, conduct, or repo1ting of the BARDA-funded research, the Contractor must
promptly notify the Contracting Officer of the corrective action taken or to be taken. The
Contracting Officer will consider the situation and, as necessary, take appropriate action
or refer the matter to the Contractor for further action, which may include directions tothe Contractor on how to maintain appropriate objectivity in the BARDA-funded research
proj ect.
The Contracting Officer and/or HHS may inquire at any time before, during, or after award
into any Investigator disclosure of financial interests, and the Contractor's review of, andresponse to, such disclosure, regardless of whether the disclosure resulted in theContractor 's determination of a financial conflict of interests. The Contracting Officer
may require submission of the records or review them on site. On the basis of this review
of records or other info1mation that may be available, the Contracting Officer may decidethat a pa1ticular financial conflict of interest will bias the objectivity of the BARDAfunded research to such an extent that further corrective action is needed or that theInstitution has not managed the financial conflict of interest in accordance with 4 5
C F R Part 94. The issuance of a Stop Work Order by the Contracting Officer may benecessary until the matter is resolved.
If the Contracting Officer determines that BARDA-funded clinical research, whose

purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment,
has been designed, conducted, or reported by an Investigator with a financial conflict ofinterest that was not disclosed managed or reported the Contractor shall require theInvestigator involved to disclose the financial conflict of interest in each publicpresentation of the results of the research and to request an addendum to previously
published presentations.
ARTICLE H.16. NEEDLE DISTRIBUTION
The Contractor shall not use contract funds to carry out any program of distributing sterile
needles or syringes for the hypodermic injection of any illegal drug.
ARTICLE H.17. RESTRICTION ON ABORTIONSThe Contractor shall not use contract funds for any abortion.
ARTICLE H.18. CONTINUED BAN ON FUNDING OF HUMAN EMBRYORESEARCH
The Contractor shall not use contract funds for ( 1) the creation of a human emb1yo or
embryos for research purposes; or (2) research in which a human embryo or embryos aredestroyed, discarded, or knowingly subjected to risk of injury or death greater than thatallowed for research on fetuses in utero under 45 CFR 46.204(b) and Section 498(b) of
the Public Health Service Act (42 U.S.C. 289g(b)). The term "human embryo or
embryos" includes any organism, not protected
as a human subject under 45 CFR 46 as of the date of the enactment of this Act, that isderived by fertilization, parthenogenesis, cloning, or any other means from one or morehuman gametes or human diploid cells.

Additionally, in accordance with a March 4, 1997 Presidential Memorandum, Federal
funds may not be used for cloning of human beings.

ARTICLE H.19. DISSEMINATION OF FALSE OR DELIBERATELYMISLEADING INFORMATIONThe Contractor shall not use contract funds to disseminate information that is deliberately
false or misleading.

ARTICLE H.20. CONFIDENTIALITY OF INFORMATION
a. Confidential information, as used in this article, means information or data of apersonal nature about an individual, or proprietary info1mation or data submitted byor pertaining to an institution or organization.
b. The Contracting Officer and the Contractor may, by mutual consent, identify
elsewhere in this contract specific information and/or categories of information
which the USG will furnish to the Contractor or that the Contractor is expected togenerate which is confidential and providing further that the Government is notentitled to unlimited rights to that information pursuant to FAR 52.227-14, Alternate
II. Similarly, the Contracting Officer and the Contractor may, by mutual consent,
identify such confidential information from time to time during the performance ofthe contract. Failure to agree will be settled pursuant to the "Disputes" clause.
c. If it is established elsewhere in this contract that info1mation to be utilized under thiscontract, or a portion thereof, is subject to the Privacy Act, the Contractor will follow
the rules and procedures of disclosure set forth in the Privacy Act of 1974, 5 U.S.C.
552a, and implementing regulations and policies, with respect to systems of records
determined to be subject to the Privacy Act.
d. Confidential information, as defined in paragraph (a) of this article, shall not be
disclosed without the prior written consent of the individual, institution, ororganization.
e. Whenever the Contractor is uncertain with regard to the proper handling of material
under the contract, or if the material in question is subject to the Privacy Act or isconfidential information subject to the provisions of this article, the Contractor
should obtain a written determination from the Contracting Officer prior to any
release, disclosure, dissemination, or publication.
f.

The provisions of paragraph (d) of this article shall not apply to conflicting or
overlapping provisions in other Federal, State or local laws.

ARTICLE H.21. ACCESS TO DOCUMENTATION/DATA

The USG shall have physical and electronic access to all documentation and data
generated under this contract, including: all data documenting Contractor performance; alldata generated; all communications and correspondence with regulatory agencies andbodies to include all audit observations, inspection reports, milestone completion
documents, and all Offeror commitments and responses. Contractor shall provide the
USG with an electronic copy of all correspondence and submissions to the FDA within 5business days of receipt. The USG shall acquire unlimited rights to all data funded under
this contract in accordance with FAR Subpait 27.4 and FAR Clause 52.227-14, Alternate
IL
ARTICLE H.22. EPA ENERGY STAR REQUIREMENTS

In compliance with Executive Order 12845 (requiring Agencies to purchase energy
efficient computer equipment), all microcomputers, including personal computers,monitors, and printers that are purchased using USG funds in performance of a contract
shall be equipped with or meet the energy efficient low-power standby feature as definedby the EPA Energy Star program unless the equipment always meets EPA Energy Star
efficiency levels. The microcomputer, as configured with all components, must be EnergyStar compliant.
This low-power feature must already be activated when the computer equipment isdelivered to the agency and be of equivalent functionality of similar power managed
models. If the equipment will be used on a local area network, the vendor must provide
equipment that is fully compatible with the network environment. In addition, theequ ipment will run commercial off-the-shelf software both before and after recovery fromits energy conservation mode.
ARTICLE H.23. ACKNOWLEDGMENT OF FEDERAL FUNDING

Section 507 of P.L. 104-208 mandates that Contractors funded with Federal dollars, inwhole or in part, acknowledge Federal funding when issuing statements, press releases,
requests for proposals, bid solicitations and other documents. This requirement is inaddition to the continuing requirement to provide an acknowledgment of support anddisclaimer on any publication reporting the results of a contract funded activity.
A. Publication and Publicity

No information related to data obtained under this contract shall be released or publicizedwithout providing the COR with at least thirty (30) days advanced notice and an
opportunity to review the proposed release or publication.

In addition to the requirements set forth in HHSAR Clause 352.227-70, Publications andPublicity incorporated by reference in SECTION I of this contract, Section 507 of P.L.
104-208 mandates that Contractors funded with Federal dollars, in whole or in part,
acknowledge Federal funding when issuing statements, press releases, requests for
proposals, bid solicitations and other documents. Contractors are required to state:(1) the percentage and dollar amounts of the total program or project costs financed with
Federal money and; (2) the percentage and dollar amount of the total costs financed bynongovernmental sources. For purposes of this contract "publication" is defined as an issue
of printed material offered for distribution or any communication or oral presentation of
information, including any manuscript or scientific meeting abstract. Any publication
containing data generated under this contract must be submitted for the COR review noless than thirty (30) calendar days for manuscripts and fifteen ( 15) calendar days for
abstracts before submission for public presentation or publication. Contract support shallbe acknowledged in all such publications substantially as follows:"This project has been funded in whole or in part with Federal funds from the Department
of Health and Human Services; Office of the Assistant Secretary for Preparedness andResponse; Biomedical Advanced Research and Development Authority, under Contract
No. HHSO100201600029C.
B. Press Releases

Misrepresenting contract results or releasing information that is injurious to the integrityof the Government may be construed as improper conduct. Press releases shall beconsidered to include the public release of information to any medium, excluding peerreviewed scientific publications. With the exception of ad-hoc press releases required byapplicable law or regulations, the Contractor shall ensure that the COR has received anadvance copy of any press release related to the contract not less than five (5) businessdays prior to the issuance of the press release.
The Contractor shall acknowledge the support of the Department of Health and Human
Service, Office of the Assistant Secretary for Preparedness and Response, Biomedical
Advanced Research and Development Authority, whenever publicizing the work under
this contract in any media by including an acknowledgment substantially as follows:"This proj ect has been funded in whole or in part with Federal funds from the Department
of Health and Human Services; Office of the Assistant Secretary for Preparedness andResponse; Biomedical Advanced Research and Development Authority, under Contract
No. HHSO100201600029C.
ARTICLE H.24. PROHIBITION ON THE USE OF APPROPRIATED FUNDS FORLOBBYING ACTIVITIES AND HHSAR 352.203-70 ANTI-LOBBYING (December
18, 2015)

The Contractor is hereby notified of the restrictions on the use of Department of Healthand Human Service's funding for lobbying of Federal, State and Local legislative bodies.
Section 1352 of Title 31, United States Code (Public Law 101-121, effective 12/23/89),
among other things, prohibits a recipient (and their subcontractors) of a Federal contract,
grant, loan, or cooperative agreement from using appropriated funds (other than profits
from a federal contract) to pay any person for influencing or attempting to influence anofficer or employee of any agency, a Member of Congress, an officer or employee ofCongress, or an employee of a Member of Congress in connection with any of thefollowing covered Federal actions; the awarding of any Federal contract; the making of
any Federal grant; the making of any Federal loan; the entering
into of any cooperative agreement; or the modification of any Federal contract, grant,
loan, or cooperative agreement. For additional infonnation of prohibitions against
lobbying activities, see .FAR Subpart 3.8 and FAR Clause 52.203- 12.
In addition, as set forth in HHSAR 352.203-70 "Anti-Lobbying'' (December 18, 2015),
the CU1Tent Department of Health and Human Services Appropriations Act provides thatno part of any appropriation contained in this Act shall be used, other than for nonnal andrecognized executive- legislative relationships, for publicity or propaganda purposes, forthe preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio,
television, or video presentation designed to support, or defeat legislation pending before
the Congress, or any State or Local legislature except in presentation to the Congress, or
any State or Local legislative body itself.

The current Department of Health and Human Services Appropriations Act also provides
that no part of any appropriation contained in this Act shalJ be used to pay the salary or
expenses of any contract or grant recipient, or agent acting fo r such recipient, related toany activity designed to influence legislation or appropriations pending before theCongress, or any State or Local legislature.
ARTICLE H.25. PRIVACY ACT APPLICABILITY
Notification is hereby given that the Contractor and its employees are subject to crimi11al
penalties for violation of the Privacy Act to the same extent as employees of tbe USG.
The Contractor shall assure that each of its employees knows the prescribed rules ofconduct and that each is aware that he or she can be subjected to criminal penalty for
violation of the Act. A copy of 45 CFR Pait 5b, Privacy Act Regulations, may beobtained at https://www.law.comell.edu/cfr/text/45/part-5b
The Project Officer is hereby designated as the official who is responsible for monitoring
contractor compliance with the Privacy Act.
The Contractor shall follow the Privacy Act guidance as contained in the Privacy Act
System of Records number 09-25-0200. This document tnay be obtained at thefollowing link: http://oma.od.nih.gov/ms/privacy/pa-fi les/0200.htm
ARTICLE H.26. LABORATORY LICENSE REQUIREMENTS
The Contractor shall comply with all applicable requirements of Section 353 of the Public
Health Service Act (Clinical Laboratory Improvement Act as amended) (42 U.S.C. 263aand 42 CFR Part 493). This requirement shall also be included in any subcontract forservices tmder the contract.

ARTICLE H.27. QUALITY ASSURANCE (QA) AUDIT REPORTS
The Government reserves the right to participate in QA audits. Upon completion of theaudit/site visit the Contractor shall provide a report capturing the findings, results andnext steps in proceeding with the subcontractor. If action is requested of the subcontractor,
detailed concerns for addressing areas of non-conformance to FDA regulations for GLP,
GMP, or GCP guidelines, as identified in the audit report, must be provided to the COR.
The Contractor shall provide responses from the subcontractors to address these concernsand plans for corrective action execution.
••

Contractor shall notify CO and COR of upcoming, ongoing, or recent audits/site
visits of subcontractors as part of weekly communications.
Contractor shall notify the COR and CO within five (5) business days ofreportcompletion.

ARTICLE H.28. TECHNICAL AUDITS
Contractor shall accommodate periodic or ad hoc site visits by the USG with forty-eight(48) hours advance notice. If the USG, the Contractor, or other parties identifies any
issues during an audit, the Contractor shall capture the issues, identify potential solutions,and provide a report to the USG.
•••

If issues are identified during the audit, Contractor shall submit a report to the CO
and COR detailing the finding and proposed corrective action(s) within 10 businessdays of the audit.
COR and CO will review the report and provide a response to the Contractor with ten( 10) business days.
Once corrective action is completed, the Contractor will provide a final report to the
CO andCOR.

ARTICLE H.29. RESTRICTION ON EMPLOYMENT OF UNAUTHORIZEDALIEN WORKERS
The Contractor shall not use contract funds to employ workers described in section 274A
(h)(3) of the Immigration and Nationality Act, which reads as follows:"(3) Definition of unauthorized alien - As used in this section, the term ' unauthorizedalien' with respect to the employment of an alien at a particular time, that the alien is notat that time either
an alien lawfully admitted for permanent residence, or (B) authorized to be so employedby this Act or by the Attorney General."
ARTICLE H.30. NOTIFICATION OF CRITICAL PROGRAMMATIC
CONCERNS, RISKS, OR POTENTIAL RISKS

If any action occurs that creates a cause for critical programmatic concern, risk, or
potential risk to the Government or the Contractor and Incident Report shall be delivered
to the CO and COR.

•••

Within 48 hours of activity or incident or within 24 hours for a security related
activity or incident, Contractor must notify the CO and COR.
Additional updates due to COR and CO w ithin 48 hours of additional developments.
Contractor shall submit within 5 business days a Corrective Action Plan (if deemednecessary by either party) to address any potential issues.

If corrective action is deemed necessary, Contractor must address in writing, itsconsideration of concerns raised by the CO or COR within 5 business days.

ARTICLE H.31. PROTECTION OF PERSONNEL WHO WORK WITHNONHUMAN PRIMATES
All Contractor personnel who work with nonhuman primates or enter rooms or areas
containing nonhuman primates shall comply with the procedures set forth in NIH Policy
Manual 3044-2, entitled, "Protection of NIH Personnel Who Work with NonhumanPrimates," located at the following URL:
http://wwwl .od.nih.gov/oma/manualchapters/intramural/3044-2/

ARTICLE H.32. DISSEMINATION OF INFORMATIONOther than scientific and technical articles for which the contractor can assert a copyrightunder FAR Clause 52.227-14 (c) no information related to data obtained under thiscontract shall be released or publicized without the prior written consent of theContracting Officer. In the event that the contractor seeks to publicize data through ascientific or technical article, the contractor shall provide the Government, through the
COR, with a minimum of thirty (30) business days to review the article prior to
publication.

ARTICLE H.33. REGISTRATION WITH THE SELECT AGENT PROGRAM
FOR WORK INVOLVING THE POSSESSION, USE, AND/OR TRANSFER OF
SELECT BIOLOGICAL AGENTS OR TOXINSWork involving select biological agents or toxins shall not be conducted under thiscontract until the Contractor and any affected subcontractor(s) are granted a certificate ofregistration or are authorized to work with the applicable select agents.
For prime or subcontract awards to domestic institutions who possess, use, and/or transfer
Select Agents under this contract, the institution must complete registration with theCenters for Disease Control and Prevention (CDC), Department of Health and Human
Services (DHHS) or the Animal and Plant Health Inspection Services (APHIS), U.S.
Department ofAgriculture (USDA), as applicable, before performing work involving
Select Agents, in accordance with 42 CFR 73. No Government funds can be used for work

involving Select Agents, as defined in 42 CFR 73, if the final registration certificate isdenied.
For prime or subcontract awards to foreign institutions who possess, use, and/or transfer
Select Agents under this contract, the institution must provide information satisfactory to
the Government that a process equivalent to that described in 42 CFR 73(http://www.selectagents.gov/Regulations.htm1 ) for U.S. institutions is in place and will
be administered on behalf of all Select Agent work sponsored by these funds before using
these funds for any work directly involving the Select Agents. The Contractor must
provide infonnation addressing the following key elements appropriate for the foreign
institution: safety, security, training, procedures for ensuring that only
approved/appropriate individuals have access to the Select Agents, and any applicablelaws, regulations and policies equivalent to 42 CFR 73. The Government will assess thepolicies and procedures for comparability to the U.S. requirements described in 42 CPR
Part 73. When requested by the contracting officer, the Contractor shall provide key
information delineating any laws, regulations, policies, and procedures applicable to theforeign institution for the safe and secure possession, use, and h·ansfer of Select Agents.
This includes swnmaries of safety, secw-ity, and training plans, and applicable laws,
regulations, and policies. For the purpose of semuity risk assessments, the Contractor
must provide the names of all individuals at the foreign institution who will have accessto the Select Agents and procedures for ensuring that only approved and appropriate
individuals have access to Select Agents under the contract.
Listings of HHS select agents and toxins. biologic agents and toxins, and overlap agentsor toxins as well as information about the registration process, can be obtained on the
Select Agent Pro!:,rt·am Web site at http://www.selectagents.gov
ARTICLE H.34. MANUFACTURING STANDARDSThe Good Manufacturing Practice Regulations (GMP)(2 l CFR Pa1is 2 10-211) will be thestandard to be appl ied for manufacturing, processing, packaging, storage and delivery ofthis product.

If at any time during the life of the contract, the Contractor fai ls to comply with GMP in
the manufactu ring, processing, packaging, storage, stability and other testing of the
manufactured drug substance or product and delivery of this product and such fail ui-e
results in a material adverse effect on the safety, pmity or potency of the product (amatei-ial failure) as identified by the FDA, the Contractor shall have thirty (30) calendar
days from the time such material failure is identified to cure such material failure. If,
within the thirty (30) calendar day period, the Contractor fails to take such an action to
the satisfaction of the USG Project Officer, or fails to provide a remediation plan that is
acceptable to the COR, then the contract may be terminated.
ARTICLE H.35. IN-PROCESS REVJEW

In Process Reviews (IPR) will be conducted at the cliscretion of the USG to cliscuss the
progression of tbe milestones. The USG reserves the right to revise the milestones andbudget pending the development of the project. Deliverables such as an overall projectsummary report and/or slides w ill be required when the IPRs are conducted. The
Contractor's success in completing the required tasks under each work segment must be
demonstrated through the Deliverables and Milestones specified under SECTION F.
Those deliverables will constitute the basis for the USG's decision, at its sole discretion,
to proceed with the work segment, or institute changes to the work segment, or tenninate
the work segment as otherwise permitted by this contract.
lPRs may be scheduled at the discretion of the USG to discuss progression of the contract.
The Contractor shall provide a presentation following a prescribed template which will be
provided by the USG at least 30 business days prior to the IPR. Sub sequently, thecontractor will be requested to provide a revised/final presentation to the Contracting
Officer at least IO business days prior to the IPR.
H.36. PUBLIC ACCESS TO ARCHIVED PUBLICATIONS RESULTING FROMASPR FUNDED RESEARCH
A ll ASPR-funded investigators shall submit to the N IH National Library of Medicine's(NLM) PubMed Central (PMC) an electronic version of the author's final manuscript,
upon acceptance for publication, of any peer-reviewed scientific publications resulting
from research supported in w hole or in part with Federal funds from the Department of
Health and Human Services; Office of the Assistant Secretary for Preparedness andResponse. ASPR defines the author's final manuscript as the final version accepted forj ournal publication, and includes a ll modifications from the publishing peer review
process. The .PMC arcliive will preserve permanently these manuscripts for use by thep ublic, health care providers, educators, scientists. andASPR. The Policy directs
electronic submissions to the NIH/NLM/PMC: http://www.pubmedcentral.ni.h.gov.
Additional information is available at
http://www.phe.gov/Preparedness/planni:ng/science/Pages/AccessPlan.aspx

PART Il · CONTRACT CLAUSESSECTION I - CONTRACT CLAUSESARTICLE 1.1. FAR 52.252-2, CLAUSES INCORPORATED BY REFERENCE(FEBRUARY 1998)
Tbjs contract incorporates the following clauses by reference, with the same force andeffect as if they were given in full text. Upon request, the Contracting Officer will maketheir full text available. Also, the full text of a clause may be accessed electronically at:https://www.acquisition.gov/
Clauses for Cost-Reimbursement Research and Development Contract

a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1)
CLAUSES:FAR
CLAUSE NO.
52.202-1
52.203-3
52.203-5
52.203-6

DATE

TITLE

Nov 2013
Apr 1984
May 2014
Sep 2006

52.203-7
52.203-8

May 2014
May 2014

52.203-10

May 2014

52.203-12

Oct 2010

52.203-13
52.203-14
52.203-17

Oct 2015
Oct 2015
Apr 2014

52.204-4
52.204-7
52.204-10

May 2011
Jul 2013
Oct 2015

52.204-13
52.204-19

Jul 2013
Dec 2014

52.209-6

Oct 2015

52.209-9

Jul 2013

52.209-10

Nov 2015

52.210-1
52.215-2
52.215-8
52.215-10
52.215-12
52.215-13

Apr 2011
Oct 2010
Oct 1997
Aug 2011
Oct 2010(Oct 2010)52.215-15
52.215-17

Oct 2010
Oct 1997

Definitions
Gratuities
Covenant Against Contingent Fees
Restrictions on Subcontractor Sales to theGovernment
Anti-Kickback Procedures
Cancellation, Rescission, and Recovery of Funds
for Illegal or Improper Activity
Price or Fee Adjustment for Illegal or Improper
Activity
Limitation on Payments to Influence Certain
Federal Transactions
Contractor Code of Business Ethics and Conduct
Display of Hotline Poster(s)Contractor Employee Whistleblower Rights andRequirement To Inform Employees ofWhistleblower Rights.
Printed or Copied Double-Sided on Recycled Paper
System for Award Management
Reporting Executive Compensation and First-Tier
Subcontract Awards
System for Award Management Maintenance
Incorporation by Reference of Representations andCertifications
Protecting the Government's Interests When
Subcontracting With Contractors Debarred,
Suspended, or Proposed for Debarment
Updates of Publicly Available Information
Regarding Responsibility Matters
Prohibition on Contracting With Inverted Domestic
Corporations
Market Research
Audit and Records - Negotiation
Order of Precedence - Uniform Contract Format
Price Reduction for Defective Cost or Pricing Data
Subcontractor Cost or Pricing Data
Subcontractor Certified Cost or Pricing DataModifications.
Pension Adjustments and Asset Reversions
Waiver of Facilities Capital Cost of Money

FAR
CLAUSE NO.
52.215-18

DATE

TITLE

Jul 2005

52.215-19
52.215-21

Oct 1997
Oct 2010

52.215-23
52.215-23

Oct 2009
Oct 2009

52.216-7
52.216-8
52.219-8
52.222-2
52.222-3
52.222-21
52.222-26
52.222-35
52.222-36
52.222-37
52.222-40

Jun 2013
Jun 2011
Oct 2014
Jul 1990
Jun 2003
Apr 2015
Apr 2015
Oct 2015
Jul 2014
Feb 2016
Dec 2010

52.222-50
52.222-54
52.223-18

Mar 2015
Oct 2015
Aug 2011

52.224-1
52.224-2
52.225-13
52.225-25

April 1984
April 1984
Jun 2008
Oct 2015

52.227-1
52.227-2

Dec 2007
Dec 2007

52.227-11

May 2014

52.227-14

May 2014

Reversion or Adjustment of Plans for PostRetirement Benefits (PRB) other than Pensions
Notification of Ownership Changes
Requirements for Cost or Pricing Data or
Information Other Than Cost or Pricing Data Modifications
Limitations on Pass-Through Charges Alternate I
Limitations on Pass-Through Charges (Over the
Simplified Acquisition threshold)Allowable Cost and Payment
Fixed Fee
Utilization of Small Business Concerns
Payment for Overtime Premiums
Convict Labor
Prohibition of Segregated Facilities
Equal Opportunity
Equal Opportunity for Veterans
Equal Opportunity for Workers With Disabilities
Employment Reports on Veterans.
Notification of Employee Rights Under the National
Labor Relations Act
Combating Trafficking in Persons
Employment Eligibility Verification
Encouraging Contractor Policy to Ban Text
Messaging While Driving
Privacy Act Notification
Privacy Act
Restrictions on Certain Foreign Purchases
Prohibition on Contracting with Entities Engaging
in Certain Activities or Transactions Relating toIran-Representation and Certifications
Authorization and Consent, Alternate I (Apr 1984)
Notice and Assistance Regarding Patent and
Copyright Infringement
Patent Rights - Ownership by the Contractor (Note:
In accordance with FAR 27.303(b)(2), paragraph (e)is modified to include the requirements in FAR
27.303(b)(2)(i) through (iv). The frequency ofreporting in (i) is annual.
Rights in Data-General

FAR
CLAUSE NO.
52.227-14Alternate II

DATE

TITLE

May 2014

Rights in Data - General, Alternate II.
Completed portion as follows:
Limited Rights Notice (Dec 2007)(a) These data are submitted with limited rights
under Government Contract No
HHSO100201600029C. These data may be
reproduced and used by the Government with theexpress limitation that they will not, without written
permission of the Contractor, be used for purposesof manufacture nor disclosed outside theGovernment; except that the Government may
disclose these data outside the Government for thefollowing purposes, provided that the Government
makes such disclosure subject to prohibition against
further use and disclosure:(i) Use (except for manufacture) by support
servicecontractors.
(ii) Evaluation by nongovernment evaluators.
(b) This Notice shall be marked on any reproductionof these data, in whole or in part.

FAR
CLAUSE NO.
52.227-14Alternate IV

DATE

TITLE

Dec 2007

Copyright-(1) Data first produced in theperformance of the contract. Except as otherwise
specifically provided in this contract, the Contractor
may assert copyright in any data first produced in
the performance of this contract. When asserting
copyright, the Contractor shall affix the applicable
copyright notice of 17 U.S.C. 401 or 402, and an
acknowledgment of Government sponsorship(including contract number), to the data when suchdata are delivered to the Government, as well as
when the data are published or deposited forregistration as a published work in the U.S.
Copyright Office. For data other than computer
software, the Contractor grants to the Government,
and others acting on its behalf, a paid-up,
nonexclusive, irrevocable, worldwide license for all
such data to reproduce, prepare derivative works,
distribute copies to the public, and perform publicly
and display publicly, by or on behalf of theGovernment. For computer software, the Contractor
grants to the Government and others acting on its
behalf, a paid-up, nonexclusive, irrevocable,
worldwide license for all such computer software to
reproduce, prepare derivative works, and perform
publicly and display publicly (but not to distributecopies to the public), by or on behalf of theGovernment.
Additional Data Requirements
Taxes - Foreign Cost Reimbursement Contracts.
Insert "Switzerland" in both blanks.
Limitation on Withholding of Payments
Interest
Limitation of Cost
Assignment of Claims
Prompt Payment, Alternate I (Feb 2002)
Payment by Electronic Funds Transfer-- System forAward Management
Unenforceability of Unauthorized Obligations.
DisputesService of Protest.
Protest After Award, Alternate I (Jun 1985)
Applicable Law for Breach of Contract Claim
Earned Value Management System
Notice of Intent to Disallow Costs

52.227-16
52.229-8

Jun 1987
Mar 1990

52.232-9
52.232-17
52.232-20
52.232-23
52.232-25
52.232-33

Apr 1984
May 2014
Apr 1984
May 2014
Jul 2013
Jul 2013

52.232-39
52.233-1
52.233-2
52.233-3
52.233-4
52.234-4
52.242-1

Jun 2013
May 2014
Sept2006
Aug 1996
Oct 2004
May 2014
Apr 1984

FAR
CLAUSE NO.
52.242-3
52.242-4
52.242-13
52.243-2
52.244-2
52.244-5
52.244-6
52.245-1
Alt. II
52.245-952.246-23
52.246-25
52.247-63
52.249-6
52.249-14
52.25 1-1
52.253-1

DATE

TITLE

May 2014
Jan 1997
Jul 1995
Aug 1987
Oct 2010
Dec 1996
Feb 2016
Apr 2012

Penalties for Unallowable Costs
Certification of Final Indirect Costs
Bankruptcy
Changes - Cost Reimbursement, Alternate V (Apr1984)
Subcontracts, Alternate I (June 2007)
Competition in Subcontracting
Subcontracts for Commercial Items
Government Property, Alternate II (Apr 2012)

Apr 2012
Feb 1997
Feb 1997
Jun 2003
May 2004
Apr 1984
Apr 2012
Jan 1991

Use and Charges
Limitation of Liability
Limitation of Liability -- Services
Preference for U.S .-Flag Air Carriers
Termination (Cost-Reimbursement)
Excusable Delays
Government Supply Sources
Computer Generated Formsb. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITIONREGULATION (HHSAR) (48 CFR CHAPTER 3) CLAUSES:
HHSAR

DATE

TITLE

CLAUSE NO.
352.211-3
352.203-70
352.222-70

Dec 2015
Dec 2015
Dec 2015

352.223-70
352.224-70
352.227-70
352.231-70
352.233-71
352.237-75
352.270-6

Dec 2015
Dec 2015
Dec 2015
Dec 2015
Dec 2015
Dec 2015
Dec 2015

Paperwork Reduction Act
Anti-Lobbying
Contractor Cooperation in Equal Employment
Opportunity Investigations
Safety and HealthPrivacy Act
Publications and Publicity
Salary Rate Limitation
Litigation and Claims
Key Personnel
Restriction on use of Human Subjects[End of GENERAL CLAUSES FOR A NEGOTIATED COST-REIMBURSEMENTRESEARCH AND DEVELOPMENT CONTRACT-Rev. 12/2011].

ARTICLE 1.2. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN
FULL TEXTThis contract incorporates the following clauses in full text.
FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1)
CLAUSES:a. FAR Clause 52.217-8, Option to Extend Services (Nov 1999)
The Government may require continued performance of any services within the limits
and at the rates specified in the contract. These rates may be adjusted only as a resultof revisions to prevailing labor rates provided by the Secretary of Labor. The option
provision may be exercised more than once, but the total extension of performancehereunder shall not exceed 6 months. The Contracting Officer may exercise theoption by written notice to the Contractor within 30 days before the contract expires.
(End of Clause)b. FAR Clause 52.217-9, Option to Extend the Term of the Contract (Mar 2000)(a) The Government may extend the term of this contract by written notice to theContractor within 30 days after the Government has completed its analysis of thedeliverables associated with all applicable milestones for each preceding contract period
identified in the Contract WBS Milestones/Deliverables and Technical Deliverables
table, except that the Government may only exercise Option 4 within 30 days after theContractor's submission of an Investigational New Drug Application ("IND") or IND
update covering the Phase 2/3 studies identified in the Statement of Work.. The
Government will provide the Contractor a preliminary written notice of its intent toextend at least 30 days before the contract expires. The preliminary notice does notcommit the Government to an extension.
(b) If the Government exercises this option, the extended contract shall be considered toinclude this option clause.
(c) The total duration of this contract, including the exercise of any options under thisclause, shall not exceed 10 years.
b. FAR Clause 52.219-28, Post-Award Small Business Program Representation(July 2013).
(a) Definitions . As used in this clause-Long-term contract means a contract of more than five years in duration,
including options. However, the term does not include contracts that exceed five
years in duration because the period of performance has been extended for acumulative pe1iod not to exceed six months under the clause at 52.217-9, Option
to Extend the Term of the Contract. or otber appropriate auth01ity.
Small business concern means a concern, including its affiliates, that is
independently owned and operated, not dominant :in the fteld of operation inwhich it is bidding on Government contracts, and qualified as a small businessunder the criteria in 13 CFR part 12 1 and the size standard in paragraph (c) of thisclause. Such a concern is "not dominant in its field of operation" when it does not
exercise a controlling or major influence on a national basis in a kind of businessactivity in wl1ich a num ber of business concerns are p1i marily engaged. In
determining whether dominance exists, consideration shall be given to all
appropriate factors, including volume of business, number of employees, financial
resources, competitive status or position, ownership or control of materials,
processes, patents, license agreements, facili6es, sales territory, and nature ofbusiness activity.
(b) If tbe Contractor represented that it was a small business concern prior toaward of this contract, the Contractor shall represent its size status according toparagraph (e) of this clause or, if applicable, paragraph (g) of this clause, upon theocctmence of any of the following:(1) Within 30 days after execution of a novation agreement or within 30
days after modification of the contract to include this clause, if thenovation agreement was executed prior to inclusfon of this clause in thecontract.

(2) Within 30 days after a merger or acquisition that does not require anovation or within 30 clays after modification of the contract to include
this clause. if the merger or acquisition occurred prior to inclusion of thisclause in the contract.
(3) For Jong-term contracts-(i) Within 60 to 120 days priorto the end of the fifth year of thecontract; and(ii) Within 60 to 120 days prior to the date specified in the contractfor exercising any option thereafter.
(c) The Contractor shall represent its size status in accordance with the size
standard in effect at th e time of this representation that coITesponds to the North
American Industry Classification System (NAICS) code assigned to this contract.
The small business size standard corresponding to this NAICS code can be foundat https://www.sba.gov/contracting/ getting-started-contractor/make-sure-youmeet-sba-size-standards/table-small-business-size-standards.

(d) The small business size standard for a Contractor providing a product w hich itdoes not manufactw-e itself, for a contract other than a construction or service
contract, is 500 employees.
(e) Except as provided in paragraph (g) of this clause, the Contractor shall makethe representation required by paragraph (b) of this clause by validating or
updating all its representations in the Online Representations and Certifications
Application and its data in the Central Contractor Registration, as necessary, toensure that they reflect the Contractor's current sta tus. The Contractor shall notify
the contracting office in writing within the timefrarnes spec ified in paragraph (b)of this clause that the data have been validated or updated, and provide the date of
the validation or update.
(f) If the Contractor represented that it was other than a small business concern

prior to award of this contrnct, the Contractor may, but is not required to, take theactions required by paragraphs (e) or (g) of this clause.
(g) If the Contractor does not have representations and certifications in ORCA, ordoes not have a representation in ORCA for the N AICS code applicable to tl1is
contract, the Contractor is required to complete the following representation andsubmit it to the contracting office, along with the conh·act number and the date on
which the representation was completed:
The Contractor represents that i ~ is not a small business concern under NAICS
Code 5417 11 assigned to contr a ~ O l00201600029C.

FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors.
PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESSSUBCONTRACTORS (DEC 201 3)(a) Upon receipt of accelerated payments from the Government, the Contractor
shall make accelerated payments to its small business subcontractors under this contract,
to the maximum extent practicable and prior to when such payment is otherwise required
under the applicable contract or subcontract, after receipt of a proper invoice and all otherrequired documentation from the small business subcontractor.
(b) The acceleration of payments under this clause does not provide any newrights under the Prompt Payment Act.
(c) Include the substance of thjs clause, including this paragraph (c), in all
subcontracts with small business concems, including subcontracts with small businessconcerns for the acquisition of commercial items.
(End of clause)

PART III-LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS
SECTION J -LIST OF ATTACHMENTS
The following documents are attached and incorporated in this contract:
1. Statement of Work

Statement of Work, dated 25 August 2016, 23 pages
2. Contract WBS Milestones/Deliverables and Technical Deliverables, 3 pages
3. Invoice/Financing Request Instructions and Contract Financial Reporting
Instructions for AMCG Cost-Reimbursement Type Contracts, 6 pages
4. Financial Report of Individual Proj ect/Contract, 1 page
5. Instructions for Completing Financial Report of Individual Project/Contract, 3
pages
6. Inclusion Emollment Report
Inclusion Enrollment Report, 5/01 (Modified OAMP: 10/01), 1 page.
7. Research Patient Care Costs
Research Patient Care Costs, 2 pages
8. Disclosure of Lobbying Activities, 2 pages
9. Earned Value M anagement (EVM) Data Item Description (DID) Sample, 16
pages.
10. 7 Principles of Earned Value Management Tier 2 System Implementation Guide,
30 pages.

PART IV - REPRESENTATIONS AND INSTRUCTIONSSECTION K- REPRESENTATIONS, CERTIFICATIONS AND OTHER
STATEMENTS OF OFFERORSThe following documents are incorporated by reference in this contract:1) Human Subjects Assurance Identification Numbers: To be provided prior to study
execution2) Animal Welfare Assurance Numbers (OLAW/PHS): To be provided prior to study
execution

End of Contract No. HHSO100201600029C

BARDA Broad Agency Announcement (BAA)(BAA-16-100-SOL-00003)
Advanced Research and Development to Expedite the Identification, Development, andManufacturing of Medical Countermeasures against. Tnfectious Disease.

ZIKA VACCINE

Contractual Statement of Work
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~ Program Management and Key Personnel
The personnel desc1ibed below will serve in their designated capacity throughout thelife of the contract. Each person will maintain responsibility for bis or her specificaspects of the successful execution of the contract. i)C4

1, L 1 Prngram Manager: ~bJf4)b)f4)

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J.3. Program Meetings

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ATTACHMENT 3
INVOICE/FINANCING REQUEST AND CONTRACT FINANCIALREPORTING INSTRUCTIONS FOR COST-REIMBURSEMENT TYPE CONTRACTS

Format: Payment requests shall be submitted on the Contractor's self-generated form in the manner and format prescribedherein and as illustrated in the Sample Invoice/ Financing Request. Standard Form 1034, Public Voucher for Purchases andServices Other Than Personal , may be used in lieu of the Contractor's self-generated form provided it contains all of theinformation shown on the Sample Invoice/ Financing Request. DO NOT include a cover letter with the payment request.
Number of Copies: Payment requests shall be submitted in the quantity specified in the Invoice Submission Instructions in
Section B of the Contract.
Frequency: Payment requests should not be submitted more frequently than once every two weeks in accordance with theAllowable Cost and Payment Clause incorporated into this contract unless otherwise instructed by the Contract Officer. Small
business concerns may subm it invoices/financing requests more frequently than every two weeks when authorized by theContracting Officer.
Cost lncurrence Period : Costs incurred must be within the contract performance period or covered by previously
established pre contract cost provisions.
Billing of Costs Incurred: If billed costs include (1) costs of a prior billing period, but not previously billed, or (2) costs
incurred during the contract period and claimed after the contract period has expired, the Contractor shall cite the amount(s)and month(s) in which it incurred such costs.
Contractor's Fiscal Year: Payment requests shall be prepared in such a manner that the Government can identify costs
claimed with the Contractor's fiscal year.
Currency: All contracts are expressed in United States dollars. When the Government pays in a currency other than UnitedStates dollars, billings shall be expressed, and payment by the Government shall be made, in that other currency at amounts
coincident with actual costs incurred. Currency fluctuations may not be a basis of gain or loss to the Contractor.
Notwithstanding the above, the total of all invoices paid under this contract may not exceed the United States dollars
authorized.
Costs Requiring Prior Approval: Costs requiring the Contracting Officer's approval, which are not set forth in an Advance
Understanding in the contract, shall be identified and reference the Contracting Officer's Authorization (GOA) Number. In
addition, the Contractor shall show any cost set forth in an Advance Understanding as a separate line item on the payment
request.
Invoice/Financing Request Identification: Each payment request shall be identified as either:(a)Interim Invoice/Contract Financing Request: These are interim payment requests submitted during the contract
performance period.

(b)Completion Invoice: The completion invoice shall be submitted promptly upon completion of the work, but no later
than one year from the contract completion date, or within 120 days after settlement of the final indirect cost rates
covering the year in which the contract is physically complete (whichever date is later). The Contractor shall submit thecompletion invoice when all costs have been assigned to the contract and it completes all performance provisions.

(c)Final Invoice: A final invoice may be required after the amounts owed have been settled between the Government andthe Contractor (e.g., resolution of all suspensions and audit exceptions).

Preparation and Itemization of the Invoice/Financing Request: The Contractor shall furnish the information set forth in the
instructions below. The instructions are keyed to the entries on the Sample Invoice/ Financing Request.
(a)Designated Billing Office Name and Address: Enter the designated billing office name and address, as identified in
the Invoice Submission Instructions in Section Band F of the Contract Schedule.

(b)Contractor's Name, Address, Point of Contact, VIN, and DUNS or DUNS+4 Number: Show the Contractor's nameand address exactly as they appear in the contract, along with the name, title, phone number, and e-mail address of theperson to notify in the event of an improper invoice or, in the case of payment by method other than Electronic Funds
Transfer, to whom payment is to be sent. Provide the Contractor's Vendor Identification Number (VIN) , and Data
Universal Numbering System (DUNS) number or DUNS+4. The DUNS number must identify the Contractor's name andaddress exactly as stated on the face page of the contract. When an approved assignment has been made by theContractor, or a different payee has been designated, provide the same information for the payee as is required for theContractor (i.e., name, address, point of contact, VIN, and DUNS).
(c)

Invoice/Financing Request Number: Insert the appropriate serial number of the payment request.

(d)Date Invoice/Financing Request Prepared: Insert the date the payment request is prepared.

(e)Contract Number and Order Number (if applicable): Insert the contract number and order number (if applicable).

(f)

Effective Date: Insert the effective date of the contract or if billing under an order, the effective date of the order.

(g)

Total Estimated Cost of Contract/Order: Insert the total estimated cost of the contract, exclusive of fixed-fee. If billingunder an order, insert the total estimated cost of the order, exclusive of fixed -fee.

(h)Total Fixed-Fee: Insert the total fixed-fee (where applicable).

(i)

Two-Way/Three-Way Match: Identify payment to be made using a three-way match.

(j)

Office of Acquisitions: Insert the name of the Office of Acquisitions, as identified in Section G of the Contract
Schedule.

(k)Central Point of Distribution: Insert the Central Point of Distribution, as identified in the Invoice Submission
Instructions in Section G of the Contract Schedule.

(I)

Billing Period: Insert the beginning and ending dates (month, day, and year) of the period in which costs were incurredand for which reimbursement is claimed.

(m)

Amount Billed - Current Period: Insert the amount claimed for the current billing period by major cost element,
including any adjustments and fixed-fee. If the Contract Schedule contains separately priced line items, identify thecontract line item(s) on the payment request and include a separate breakdown (by major cost element) for each line
item.

(n)

Amount Billed - Cumulative : Insert the cumulative amounts claimed by major cost element, including any adjustments
and fixed-fee. If the Contract Schedule contains separately priced line items, ident ify the contract line item(s) on thepayment request and include a separate breakdown (by major cost element) for each line item.

(o)Direct Costs: Insert the major cost elements. For each element, consider the application of the paragraph entitled"Costs Requiring Prior Approval" on page 1 of these instructions.
(1 )

(2)

Direct Labor: Include salaries and wages paid (or accrued) for direct performance of the contract.
For Level of Effort contracts only, the Contractor shall provide the following information on a separate sheet ofpaper attached to the payment request:- hours or percentage of effort and cost by labor category (as specified in the Level of Effort Article in Section
F of the contract) for the current billing period, and- hours or percentage of effort and cost by labor category from contract inception through the current billing
period. (NOTE: The Contracting Officer may require the Contractor to provide additional breakdown for
direct labor, such as position title, employee name, and salary or hourly rate.)(3)

Fringe Benefits: List any fringe benefits applicable to direct labor and billed as a direct cost. Do not include inthis category fringe benefits that are included in indirect costs.

(4)

Accountable Personal Property: Include permanent research equipment and general purpose equipment having
a unit acquisition cost of $1,000 or more, with a life expectancy of more than two years, and sensitive property
regardless of cost (see the HHS Contractor's Guide for Control of Government Property). Show permanent
research equipment separate from general purpose equipment.

On a separate sheet of paper attached to the payment request, list each item for which reimbursement isrequested. An asterisk(*) shall precede the item if the equipment is below the $1,000 approval level. Include
reference to the following (as applicable):- item number for the specific piece of equipment listed in the Property Schedule , and- COA number, if the equipment is not covered by the Property Schedule.
T he Contracting Officer may require the Contractor to provide further itemization of property having specificlimitations set forth in the contract.
(5)

Materials and Supplies: Include equipment with unit costs of less than $1,000 or an expected service life of two
years or less, and consumable material and supplies regardless of amount.

(6)

Premium Pay: List remuneration in excess of the basic hourly rate.

(7)

Consultant Fee: List fees paid to consultants. Identify consultant by name or category as set forth in the contract
or COA, as well as the effort (i.e., number of hours, days, etc.) and rate billed.

(8)

Travel: Include domestic and foreign travel. Foreign travel is travel outside of Canada, the United States and its
territories and possessions. However, for an organization located outside Canada, the United States and its
territories and possessions, foreign travel means travel outside that country. Foreign travel must be billed
separately from domestic travel.

(9)

Subcontract Costs: List subcontractor(s) by name and amount billed. Cite applicable COA or notification .

(10) Other: List all other direct costs in total unless exceeding $ 1,000 in amount. If over $1 ,000, list cost elements anddollar amounts separately. If the contract contains restrictions on any cost element, that cost element must be
listed separately.
(p)

(q)

Cost of Money (COM) : Cite the COM factor and base in effect during the time the cost was incurred and for which
reimbursement is claimed.
Indirect Costs: Identify the indirect cost base (IDC), indirect cost rate, and amount billed for each indirect cost
category.

(r)

Fixed-Fee: Cite the formula or method of computation for fixed-fee, if applicable. The fixed -fee must be claimed asprovided for by the contract.

(s)
(t)

Total Amounts Claimed: Insert the total amounts claimed for the current and cumulative periods.
Adjustments: Include amounts conceded by the Contractor, outstanding suspensions, and/or disapprovals subject toappeal.

(u)Grand Totals(v)

Certification of Salary Rate Limitation: If required by the contract (see Invoice Submission Instructions in Section Gof the Contract Schedule), the Contractor shall include the following certification at the bottom of the payment request:"I hereby certify that the salaries billed in this payment request are in compliance with the Salary Rate Limitation
Provisions in Section Hof the contract."(w)

Signature

The Contracting Officer may require the Contractor to submit detailed support for costs claimed on one or moreinterim payment requests.
FINANCIAL REPORTING INSTRUCTIONS:
These instructions are keyed to the Columns on the sample invoice/financing request.

Column A- Expenditure Category: Enter the expenditure categories required by the contract.

Column B - Cumulative Percentage of Effort/Hrs. - Negotiated: Enter the percentage of effort or number of hours agreed
to for each employee or labor category listed in Column A.
Column C - Cumulative Percentage of Effort/Hrs. - Actual: Enter the percentage of effort or number of hours worked byeach employee or labor category listed in Column A.
Column D - Amount Billed - Current: Enter amounts billed during the current period.
Column E - Amount Billed - Cumulative: Enter the cumulative amounts to date.
Column F - Cost at Completion : Enter data only when the Contractor estimates that a particular expenditure category willvary from the amount negotiated. Realistic estimates are essential.
Column G - Contract Amount: Enter the costs agreed to for all expenditure categories listed in Column A.
Column H - Variance (Over or Under): Show the difference between the estimated costs at completion (Column F) andnegotiated costs (Column G) when entries have been made in Column F. This column need not be filled in when Column Fis
blank. When a line item varies by plus or minus 10 percent, i.e., the percentage arrived at by dividing Column F by Column G,
an explanation of the variance should be submitted. In the case of an overrun (net negative variance), this submission shallnot be deemed as notice under the Limitation of Cost (Funds) Clause of the contract.

Modifications: Any modification in the amount negotiated for an item since the preceding report should be listed in theappropriate cost category.
Expenditures Not Negotiated: An expenditure for an item for which no amount was negotiated (e.g., at the discretion of theContractor in performance of its contract) should be listed in the appropriate cost category and all columns filled in, except for
G. Column H will of course show a 100 percent variance and will be explained along with those identified under H above.

SAMPLE INVOICE/ FINANCING REQUEST AND CONTRACT FINANCIALREPORT(a}

Designated Billing Office Name and Address:
DHHS/OS/ASPR/BARDA
Attn: Contracting Officer
330 Independence Ave., S.W.
Room G644
Washington, D.C. 20201(b}

Contractor's Name, Address, Point of Contact, V~
and DUNS or DUNS+4 Number:
ABC CORPORATION
100 Main Street
Anywhere, USA Zip CodeName, Title, Phone Number, and E-mail Address of
person to notify in the event of an improper invoice
or, in the case of payment by method other thanElectronic Funds Transfer, to whom payment is tobe sent.

(c)

Invoice/ Financing Request No.:(d)Date Invoice Prepared:(e)Contract No. and Order No. (if applicable):(f)

Effective Date:(g)

Total Estimated Cost of Contract/Order:

(h)
(i)

Total Fixed-Fee (if applicable):
Two-Way Match:Three-Way Match:(j)

Office of Acquisitions:(k)Central Point of Distribution:

VIN:
DUNS or DUNS+4:(I) This invoice/financino request represents reimbursable costs tor the period from
Cumulative Percentage ofEffort/Hrs.
Expenditure Category•A

NegotiatedB

ActualC

toAmount Billed(m)Current
D(n)CumulativeE(o) Direct Costs:( 1) Direct Labor(2) Fringe Benefits(3) Accountable Property(4) Materials & Suoolies(5) Premium Pay(6) Consultant Fees
(7) Travel(8) Subcontracts(9) Other
Total Direct Costslo\ Cost of Moneyla\ Indirect Costs(r) Fixed Fee(s) Total Amount Claimed(t) Adjustments(u) G rand Totals
I certify that all payments are for appropriate purposes and in accordance with the contract.

(Name of Official)• Attach details as specified in the contract(Title)Cost atCompletion
F

Contract
AmountG

Variance
HAttachment 3
Date of Report:

Contract No.:

Project Task:

0990-0134
0990-0131

FINANCIAL REPORT OF INDIVIDUAL
PROJECT/CONTRACT
Note: Complete this Form in Accordance withAccompanying Instructions.

Percentage ofEffort/Hours
Expenditure Category

A

00

c.o

NegotiatedActualB

C

Contractor Name and Address:

Reporting Period:

Cumulative
Incurred Cost
at End of Prior
PeriodIncurred Cost-Current
PeriodCumulative
Cost to Date (D+ E)

Estimated Cost
to Complete

Estimated Cost atCompletion (F + G)

NegotiatedContract Amount

Variance (Overor Under) (I - H)

D

E

F

G

H

l

J

Attachment 4
INSTRUCTIONS FOR COMPLETING"FINANCIAL REPORT OF INDIVIDUAL PROJECT/CONTRACT"GENERAL INFORMATION
Purpose. This Quarterly Financial Report is designed to: (1) provide a management tool for use by be BARDA inmonitoring the application o f financial and personnel resources to the BARDA contracts; (2) provide contractors
with financial and personnel management data which is usable in their management processes; (3) promptly
indicate potential areas of contract underruns or overruns by making possible comparisons of actual performanceand projections with prior estimates on individual elements of cost and personnel; and (4) obtain contractor's
analyses of cause and effect of significant variations between actual and prior estimates of fin ancial and personnel
performance.

REPORTING REQUIREMENTS
Scope. The specific cost and personnel elements to be reported shall be established by mutual agreement prior toaward. The Government may require the contractor to provide detailed documentation to support any element(s) on
one or more financial reports.
Number of Copies and Mailing Address. An original and two (2) copies of the report(s) shall be sent to thecontracting officer at the address shown on the face page of the contract, no later than 30 working days after the endof the period reported. However, the contract may provide for one of the copies to be sent directly to theContracting Officer's Technica l Representative.

REPORTING STATISTICS
A modification which extends the period of performance of an existing contract will not require reporting on a
separate quarterly report, except where it is determ ined by the contracting officer that separate reporting isnecessary. Furthermore, when incrementally funded contracts are involved, each separate allotment is notconsidered a separate contract entity (only a funding action). Therefore, the statistics under incrementally funded
contracts should be reported cumulatively from the inception of the contract through completion.

Definitions and Instructions for Completing the Quarterly Report. For the purpose of establishing expenditurecategories in Column A, the following definitions and instructions will be utilized. Each contract will specify thecategories to be reported.
(1) Key Personnel. Include key personnel regardless of annual salary rates. All such individuals should be listed
by names and job titles on a separate line including those whose salary is not directly charged to the contract
but whose effort is directly associated with the contract. The listing must be kept up to date.
(2) Personnel-Other. List as one amount unless otherwise required by the contract.

90

(3) Fringe Benefits. Include allowances and services provided by the contractor to employees as compensation in
addition to regular salaries and wages. If a fringe benefit rate(s) has been established, identify the base, rate,
and amount billed for each category. If a rate has not been established, the various fringe benefit costs may berequired to be shown separately. Fringe benefits which are included in the indirect cost rate should not beshown here.
(4) Accountable Personal Property. Include nonexpendable personal property with an acquisition cost of$1,000 or more and with an expected useful life of two or more years, and sensitive items regardless of cost.
Form 1-ll-IS 565, "Report of Accountable Property," must accompany the contractor's public voucher (SFI 034/SF I 035) or this report if not previously submitted. See "Contractor's Guide for Control of Government
Property."(5) Supplies. Include the cost of supplies and material and equipment charged directly to the contract, but
excludes the cost of nonexpendable equipment as defined in (4) above.
(6) Inpatient Care. Include costs associated with a subject while occupying a bed in a patient care setting. It
normally includes both routine and ancillary costs.
(7) Outpatient Care. Include costs associated with a subject while not occupying a bed. It normally includes
ancillary costs only.

(8) Travel. Include all direct costs of travel, including transportation, subsistence and miscellaneous expenses.
Travel for staff and consultants shall be shown separately. Identify foreign and domestic travel separately. If
required by the contract, the following information shall be submitted: (i) Name of traveler and purpose oftrip; (ii) Place of departure, destination and return, including time and dates; and (iii) Total cost of trip.
(9) Consultant Fee. Include fees paid to consultant(s). Identify each consultant w ith effort expended, billingrate, and amount billed.
(I 0) Premium Pay. Include the amount of salaries and wages over and above the basic rate of pay.
(11) Subcontracts. List each subcontract by name and amount billed.
(12) Other Costs. Include any expenditure categories for which the Government does not require individual line
item reporting. It may include some of the above categories.
(13) Overhead/Indirect Costs. Identify the cost base, indirect cost rate, and amount billed for each indirect cost
category.
(14) General and Administrative Expense. Cite the rate and the base. In the case of nonprofit organizations, thisitem will usually be included in the indirect cost.
(15) Fee. Cite the fee earned, if any.

( l 6) Total Costs to the Government.

PREPARATION INSTRUCTIONS
These instructions are keyed to the Columns on the Quarterly Report.

91Column A--Expenditure Category. Enter the expenditure categories required by the contract.
Column B--Percentage of Effort/Hours Negotiated. Enter the percentage of effort or number of hours agreed toduring contract negotiations for each labor category listed in Column A.
Column C--Percentage of Effort/Hours-Actual. Enter the cumulative percentage of effort or number of hours
worked by each employee or group of employees listed in Column A.
Column D--Cumulative Incurred Cost at End of Prior Period. Enter the cumulative incurred costs up to theend of the prior reporting period. This column will be blank at the time of the submission of the initial report.
Column E--Incurred Cost-Current Period. Enter the costs which were incurred during the current period.
Column F--Cumulative Incurred Cost to Date. Enter the combined total of Columns D and E.
Column G--Estimated Cost to Complete. Make entries only when the contractor estimates that a particularexpenditure category will vary from the amount negotiated. Realistic estimates are essential.
Column H--Estimated Costs at Completion. Complete only if an entry is made in Column G.
Column !--Negotiated Contract Amount. Enter in this column the costs agreed to during contract negotiations
for all expenditure categories listed in Column A.
Column J--Variance (Over or Under). Complete only if an entry is made in Column H. When entries have been
made in Column H, this column should show the difference between the estimated costs at completion (Column H)
and negotiated costs (Column I). When a line item varies by plus or minus 10 percent, i.e., the percentage arrived
at by dividing Column J by Column I, an explanation of the variance should be submitted. In the case of an
overrun (net negative variance), this submission shall not be deemed as notice under the Limitation of Cost (Funds)
Clause of the contract.
Modifications. List any modification in the amount negotiated for an item since the preceding report in theappropriate cost category.
Expenditures Not Negotiated. List any expenditure for an item for which no amount was negotiated (e.g., at thediscretion of the contractor in performance of its contract) in the appropriate cost category and complete allcolumns except for I. Column J will of course show a I 00 percent variance and will be explained along with those
identified under J above.

92

Program Director/Principal Investigator (last, First, Middle) :Inclusion Enrollment Report
This report format should NOT be used for data collection from study participants.
Study Title:
Total Enrollment:- - - - - - - - - - - - - - Protocol Number: - - - - - - - - - - - - - -Grant Number:
PART A. TOT AL ENROLLMENT REPORT:

Ethnic Category

Number of Subjects Enrolled to Date (Cumulative)by Ethnicity and Race
Sex/Gender
Unknown orFemales
Males
Not Reported

Total

**

Hispanic or Latino
Not Hispanic or Latino
Unknown (individuals not reporting ethnicity)*

Ethnic Category: Total of All Subjects•
Racial Categories
American Indian/Alaska Native
Asian
Native Hawaiian or Other Pacific IslanderBlack or African American
White
More Than One Race
Unknown or Not Reported*

Racial Categories: Total of All Subjects*

PART B. HISPANIC ENROLLMENT REPORT: Number of Hispanics or Latinos Enrolled to Date (Cumulative)~acial Categories

Females

Males

Sex/Gender
Unknown or
Not Reported

Total

American Indian or Alaska Native
Asian
Native Hawaiian or Other Pacific IslanderBlack or African American
White
More Than One Race
Unknown or Not Reported
Racial Categories: Total of Hispanics or Latinos****• These totals must agree.
*" These totals must agree.
0925-0001 /0002 (Rev. 08/12)

Inclusion Enrollment Report Format Page

Attachment 7
Research Patient Care Costs(a) Research patient care costs are the costs of routine and ancillary services provided to patients
participating in research programs described in this contract.
(b) Research patient care costs shall be computed in a manner consistent with the principles andprocedures used by the Medicare Program for determining the part of Medicare reimbursement based onreasonable costs. The Diagnostic Related Group (DRG) prospective reimbursement method used todetermine the remaining portion of Medicare reimbursement shall not be used to determine researchpatient care costs . Research patient care rates or amounts shall be established by the Secretary of HHSor his/her duly authorized representative.
(c) Prior to submitting an invoice for research patient care costs under this contract, the contractor must
make every reasonable effort to obtain third party payment, where third party payers (including
Government agencies) are authorized or are under a legal obligation to pay all or a portion of the charges
incurred under this contract for research patient care.
(d) The contractor must maintain adequate procedures to identify those research patients participating inthis contract who are eligible for third party reimbursement.
(e) Only those charges not recoverable from third party payers or patients and which are consistent withthe terms and conditions of the contract are chargeable to this contract.

ATTACH MENT #8

DISCLOSURE OF LOBBYING ACTIVITIESApproved by 0MB

Complete this form to disclose lobbying activities pursuant to 31 U.S.C, 1352
0348-0046(See reverse for oubllc burden disclosure.)
1. Type of Federal Action:
2. Status of Federal Action:
3. Report Type:-a.
bid/offer/application~ a. initial filinga. contract
b. grant
b. initial award
b. material changec. cooperative agreementc. post-award
For Material Chan_g e Only:
d. loanyear
quarter
e. loan guarantee
date of last report
f. loan insurance
4. Name and Address of Reporting Entity :5. If Reporting Entity in No. 4 is a Subawardee, Enter Name
0 Subawardeeand Address of Prime:
0 PrimeTier
if known :n'Conaressionat District, if known : 4c
6. Federal Department/Agency:

Conaressional District, if known :7. Federal Program Name/Description:

CFDA Number, if applicable:
8. Federal Action Number, if known:

9. Award Amount, if known:$
10. a. Name and Address of lobbying Registrant( if individual, fast name, first name, Ml):

b. Individuals Performing Services (including address if
different from No. 1Oa)
(fast name, first name, Ml) :11 lnformarion requested through th,s fonn <S authorized by tille 31 U.S.C. secl;on

Signature :• ·1352, Thls disclosure or fobbyfng actTvities 1s a material representation of lad
upon which reliance was placed by the lier above wt,en thus tranoaction was madeor entered Into. Tl1ls dlsolosure is- required pursuant to 31 U.S.C. 1352 . Thislnfonnation will be available for public lnspechon. Any person who fails to f ile therequired ,disclosure shall be subject to a oivil penalty of not less u,an $10,000 and
not more lt>an $100.000 for each such ta1lure,

Print Name:
Title:
Telephone No.;

Date :

I

Federal Use Only:

Authorized for Local Reproduction
Standard Form LLL (Rev. 7-97)

PRINT

96

INSTRUCTIONS FOR COMPLETION OF SF-LLL, DISCLOSURE OF LOBBYING ACTIVITIESThis disclosure form shall be completed by the reporting entity, whether subawardee or prime Federal recipient, at the initiation or receipt of a covered Federal
action, or a material change to a previous filing, pursuant to title 31 U.S.C. section 1352. The filing of a form is requ ired for each payment or agreement to makepayment to any lobbying entity for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee ofCongress, or an employeeof a Member of Congress in connection with a covered Federal action. Complete all items that apply for both the initial filing and materialchange report. Refer to the implementing guidance published by the Office of Management and Budget for additional information.

1. Identify the type of covered Federal action for which lobbying activity is and/or has been secured to influence the outcome of a covered Federal action.
2. Identify the status of the covered Federal action.
3. Identify the appropriate classification of this report. If this is a followup report caused by a material change to the information previously reported, enter
the year and quarter in which the change occurred. Enter the date of the last previously submitted report by this reporting entity for this covered Federal
action.
4. Enter the full name, address, city, State and zip code of the reporting entity. Include Congressional District, if known. Check the appropriate classificationof the reporting entity that designates if it is, or expects to be, a prime or subaward recipient. Identify the tier of the subawardee, e.g., the first subawardeeof the prime is the 1st tier. Subawards include but are not limited to subcontracts, subgrants and contract awards under grants.
5. If the organization filing the report in item 4 checks "Subawardee," then enter the full name, address, city, State and zip code of the prime Federal
recipient. Include Congressional District, if known.
6. Enter the name of the Federal agency making the award or loan commitment. Include at least one organizational level below agency name, if known. For
example, Department of Transportation, United States Coast Guard.
7. Enter the Federal program name or description for the covered Federal action (item 1). If known , enter the full Catalog of Federal Domestic Assistance(CFDA) number for grants, cooperative agreements, loans, and loan commitments.
8. Enter the most appropriate Federal identifying number available for the Federal action identified in item 1 (e.g., Request for Proposal (RFP) number;
Invitation for Bid (IFB) number; grant announcement number; the contract, grant, or loan award number; the application/proposal control number
assigned by the Federal agency). Include prefixes, e.g., "RFP-DE-90-001."
9. For a covered Federal action where there has been an award or loan commitment by the Federal agency, enter the Federal amount of the award/loancommitment for the prime entity identified in item 4 or 5.
10. (a) Enter the fu ll name, address, city, State and zip code of the lobbying registrant under the Lobbying Disclosure Act of 1995 engaged by the reporting
entity identified in item 4 to influence the covered Federal action.
(b) Enter the fu ll names of the individual(s) performing services, and include full address if different from 10 (a). Enter Last Name, First Name, andMiddle Initial (Ml).
11. The certifying official shall sign and date the form , print his/her name, title, and telephone number.
According to the Paperwork Reduction Act, as amended, no persons are required to respond to a collection of information unless it displays a valid 0MB Control
Number. The valid 0MB control number for this information collection is 0MB No. 0348-0046. Public reporting burden for this collection of information isestimated to average 10 minutes per response, including time for reviewing instructions, searching existing data sources, gathering and maintaining the dataneeded, and completi ng and reviewing the collection of information. Send comments regarding the burden estimate or any other aspect of this collection of
information, including suggestions for reducing this burden, to the Office of Management and Budget, Paperwork Reduction Project (0348-0046), Washington,
DC 20503.

97

ATTACHMENT #9

DATA ITEM DESCRIPTIONTITLE : CONTRACT PERFORMANCE REPORT (CPR)
NUMBER : DI - MGMT-81466A
APPROVAL DATE : 20050330
AMSC NUMBER:
D7549
LIMITATION :DTIC APPLICABLE:
GIDEP APPLICABLE:
PREPARING ACTIVITY: OUSD(AT&L)ARA/AM(SO)APPLICABLE FORMS: DD Forms are available and shall be used to submit required
formats as follows :CPR Format
Work Breakdown St ruct ure
Organi zationa l Categories
Baseline
Staffing
Expl anations and Probl em Analyses

DD Form Number
2734/12734/22734/32734/42734/5

Sample Format No .
1
2

3
4
5

USE/RELATIONSHIP: Thi s report: consisrs of five formars cont:aining dat:.a formeasuring contractors ' cost and schedule performance on Department of Defense(DoD) acquisition contracts . Format 1 (Sampl e Format 1) provides data tomeasure cost and schedule performance by product-oriented Work Breakdown
Structure (WBS) elements , the hardware , software, and services the Governmentis buying .
Format 2 (Sample Format 2) provides the same data by thecontractor ' s organization (functional or Integrat ed Product Team (IPT)
structure) . Format 3 (Sample Format 3) provides the budget basel i ne plan
against which performance is measured . Format 4 (Sample Format 4) provides
staffing forecas t s for correlat ion with the budget plan and cost estimates .
Format 5 (Sample Format 5) is a narrative report used to explain significant
cost and schedule variances and other identified contract problems and topics.
CPR dat a shall be used by DoD system managers to :(1) integrate cost andschedule performance data with technica l performance measures , (2) identify
the magnitude and impact of actual a11d potential problem areas causing
significant cost: and schedu l e variances , and (3) provide va l id , t i mely program
status information to higher management .
The CPR is a management report .
It provides t imely , reliabl e summary-level
data with which to assess current and projected contract performance . The
CPR ' s primary value to t:he Government is i t s abilit y to ref l ect current
contract status and reasonably project future program performance .
It isimportant that the CPR be as accurate as possible so i t may be used for its
intended purpose , which is to facilitate informed , timely deci sions .
It wi l lbe used by the DoD component staff , including program managers , engineers ,cost estimators, and financial management personnel , to conf irm, quanti f y , andtrack k nown or emerging contract problems and serve as a basis forcommunicating with the contractor. The CPR data shall accurately reflect how
work is being planned, performed, and measur e d and shall be consistent withthe actual contract status .
a . This Data Item Description (D ID ) contains the format and content
preparation instructions for the data prod uct generat ed by the spec i f i c anddiscrete tas k requirements as d elineat ed in the contract .
b.
This DID shall be used in conjunction with the Integrated Master Schedule(IMS) DI D, DI-MGMT- 8 1 650 . This DID may be used in conjunct i on with theContract Funds Status Report (CFSR) DID, DI-MGMT- 81468, the Contract Work
Breakdown Structure (CWBS) DID , DI- MGMT- 81334A, the Cost Data Summary Report
DID , DI-FNCL-81565A, and the Funct ional Cost-Hour and Progress Curve Report98DI-MGMT- 81466A

DID, DI -FNCL-8 1 566A . The same WBS shall be utilized for the I ntegrated Master
Plan ( IMP) , IMS , CPR, and Contractor Cost Data Report (CCDR) as applicable .
c . The CPR shall be use d t o obta i n cost and schedule performance informationon contracts req uiring comp liance with the American National Standards
Inst i tute/Electronic Industries Alliance S t andard 74 8 (ANSI/E I A- 748) , Earne dValue Management Systems (EVMS) (current version in effect at t i me of cont r act
award) . Refer to t he Federal Acquisition Regulat ion (FAR) or Defense Federal
Acquisition Regulation Supplement (DFARS) clause on c ontract. The CPR data
elements shall reflect the output of the contractor ' s ANSI/EIA- 748 compliant
int egrated management system .
d . The CPR shall be r e quired no l ess fre quent ly than monthl y . Al l f orma ts
shall be submitted to the procuring activity no later than 1 2 work ing days
following t he contractor ' s accounting period cutoff dat e . This requirement
may be ta il ored through contract negot iations to allow submi ssion as l ate as
17 working days , provided that the contractor and Government agree that
program comp lexit y and integration of subcontract or and vendor performancedata warrant additional time and will y i eld more accurate performa nce .
Reports may reflect data either as of t he end of the calendar month or as oft he c ont ractor ' s accounting period cutoff dat e , provided it is cons i stent with
the IMS . Formats 2 , 3 , and 4 may be submitted on a less frequent basis insome cases . Refer to t he Earned Value Management Implementat ion Guide (EVMIG)
for guidance on tailo ring report ing .
(Note : Cont ractors may elect to attach
subcontractor Format 5 reporting and cross reference this analysis in theFormat 5 r eporting submi t ted to t he Government to gain t ime e f f i c i enci es andmeet submi ssion dates . )e . Unless o t herwise provi ded in the contract, data reported i n the CPR shal lpertain to all authorized contract work , includ ing both priced and unpriced
effort . Refer to t he EVMIG for guidance on tailoring reporting .
f . Submission of Format 1 using a product - oriented WBS in accor dance with the
WBS Handbook , MIL- HDBK- 881 , and t he CWBS DI D, DI - MGMT- 81334A, is mandato r y .
(Note : For c ontrac ts that require CCDRs , the CWBS shall be developed,
approved, and maint ained in accordance with DoD 5000 . 4-M-l , Cost and Software
Data Repo rting Manual, and the CWBS DID . ) Cert ain aspect s of the report a resubject to negotiation between the Government and the contractor , such as :f .l
The leve l of d etail to be reported in Fo rmat 1 normally wi l l be at l e v e lthree of the CWBS, but lower levels may be specified for high- cost or highr i sk items . The Government and t he c ontrac tor shall periodi cal l y review andadjust as necessary CWBS reporting levels on Fo rmat 1 t o ensure they continue
t o provide appropriate visibility without requiring excessive informat i on . I ft here is a sign ificant problem a t a l ower level, detailed report i ng f or t hat
CWBS element may be required until the problem is resolved .
f . 2 Formats 1 and 5 are mandat ory in a ll cases . Formats 2 , 3 , and 4 are
optional in some cases . Refer to the EVMIG for guidance on tailoring
reporting .
f . 3 Variance analysis thresholds which , if exceeded, require p roblem analysis
and narrative e xplanat ions in Format 5 . If t he contract does not speci f yvariance analysis thresholds , the contractor shall provide appropri ate
variance analyses .
(See 2 . 6 . 3 below . ) Variance analysis t hresholds shall be
reviewed peri odically and a d justed as necessary to ensure they cont i nue toprovide appropriate visibility .

299DI-MGMT- 81466A

f . 4 If the organ iz ational catego ries for Format 4 are d i f f erent from Format
2 , the Government may request t hat different organizational categories be used
for reporting staffing i n Format 4 i nstea d o f t hose used i n Format 2 . I f so ,the Government and the contractor shall negotiate the Format 4 categories . I f
required, t he Format 2 categories shall reflect t he cont r actor ' s i nternalorganiz ation be i ng used to execute the contract .
g . Subj ect t o f ., the CPR Contract Data Re quirement s Li st (CORL) is subject
to tailoring . Requiring more information in the CPR CORL than specified int his DID is contrary to DoD policy . All negotiat ed reporting p rov isions shallbe spec i fied i n the contract . Refer to the EVMIG for g u idance on tai l oring
rep orting .
REQUIREMENTS:

1 . Format . Use the r e l evant DD Forms as listed above . All formats shall be
submitted electronically in accordance with the following requirements . Allformats shall be in a readable d igital format (e . g ., pdf files are notacceptable) . The American National Standards I nstitute (ANSI) Xl2 standard(839 transaction set ) , the United Nations Electronic Data Interchange fo r
Admi n ist ration , Comme rce and Transport (UN/ EDIFACT) standard (PROCST message) ,or the XML e qui valent shall be use d to submit data elect r oni cal l y to the
procuring act ivit y . Cont ract or formats may be substituted whenever theyc ontain a ll of the r e quired dat a elements at the specified report i ng l evels
and are compliant with the Xl2 standard, XML schema , or e quivalent . On- line
access to t he data may be provided to augment formal CPR submission .
(Note :
Until the ANSI Xl2 /XML s tanda r ds are redefined to incorpo r ate the change s to
the forms , the new data elements shall be reported in Format 5 . )2.

Content.

The CPR shall contain t he following :2 .1 Headi ng Info rmation - Formats 1 - 5 . Preparation i nstructions f or
Head ing Information (Blocks 1 through 4) apply to Formats 1 through 5 .
2 . 1 . 1 Cont ract or . Ent er in Block l . a the cont ract or ' s name and division (ifappli cable) . Enter in Block l . b the facili t y l ocation and mai l i ng addr ess oft he reporting contractor .
2 . 1 . 2 Cont ract. Ent er t he contract name in Blo c k 2 . a , t he c ontrac t numb e r(and the applicable Contract Line Item Number (s) (CLIN (s)) in Block 2 . b , thecontract type in Block 2 . c , and t he contract share ratio (if applicable) in
Bl ock 2 . d .
2 . 1 . 3 Program . Enter in Block 3 . a the p rogram name , number , acronym, type ,model , and series, o r other des i gnation of the pr i me item(s) p u rchased under
the c ontract . Indicate the program phase (development , pro duct i o n , etc . ) i n
Block 3 .b.
Indicat e whether the cont ract or ' s EVMS has been accepted by theGovernment and the date o f the accept ance .
2 . 1 . 4 Report Period . Enter the beginning date in Bl ock 4 . a and the ending
dat e in Block 4 . b of the period covered by the report.
2 . 1 . 5 Security Cl ass i f icat i on . Enter the appropriat e security class ification
at the top and bottom of each page .
2 . 1 . 6 Do llar s in
If reported dollar amounts are i n thousands,
millions , or billions , enter the fact or at the top of each page .

3100

DI-MGMT-81466A
2 .2
2 . 2 .1

Format 1 - Work Breakdown S tructure .
Contract Data.

2 . 2 . 1 . 1 Quantity . Ente r in Block 5 . a the number o f pri ncipal items to b e
procured on this contract .
2.2. 1 .2 Negotiated Cost . Enter in Block 5 .b t he dollar value (excluding fee
or profit) on which contractual agreement has been reached as o f the cutoff
date of the report . For an incentive contract , enter the definitized contract
target cost . Amounts for changes shal l not be i ncluded in thi s item until
they have been priced and incorporated in the contract through contract changeorder or supplement al agreement . For a cost p l us fixed fee , award f ee , orincenrive fe e contracr , enter the estimated cos t negoriated . Changes to theestimated cost shall consist only of estimated amounts for changes in thecontract scope of work , not f or cost growth ( " overrun" ) above the original
estimated cost .
2 . 2 . 1 . 3 Estimated Cost of Authorized , Unpr i c e d Work . Enter i n Block 5 . c theamount (excluding fee or profit) estimated for that work for which written
authori zation has been received, but for which definitized contract prices
ha ve not been incorporated in the contract through contract change order or
supplemental agreement .
2 . 2 . 1 . 4 Target Profit/Fee . Encer i n Bl ock 5 . d the f ee or per c encage of
profi t thatshall apply if the negotiated c ost of the contract is met.
(See
2 . 2. 1 . 2 above . )2.2 . 1 . 5 Target Pr i ce . Enter in Block 5 . e the target price (negotia t ed
concract cost plus prof it /fee) a p p li cable to che definicized contract ef f ort.
2 . 2 . 1 . 6 Es timated Price . Based on the most likely estimate of cost atcompletion for all authorized contract work and the appropriate profit/fee ,incentive , and cost sharing provisions , enter in Block 5 . f the estimated f ina lconcracc pr ice (total estimated case ro the Governmenc) . This number shall bebased on the most li kely management EAC in Block 6 . c . l and normal l y wil lchange whenever t he management e s timate or the c o nt ract is revised .
2 . 2 . 1 . 7 Con t ract Ceiling . Enter in Block 5 .g the contract ceiling pri ce
applicable to the defin iti z e d eff ort.
2 . 2 . 1 . 8 Est imated Cont ract Ceiling . Enter in Block 5 . h the estimated ceiling
price appl ic able to all aut horized cont ract effort including both defi n i t i zed
and undefinitized effort .
2 . 2 . 1 . 9 Over Target Baseline/Over Target Schedule . Enter in Bl ock 5 . i t hedate the last over target baseline or over target schedule was implemented ( ifapp li cabl e) .
2 . 2 . 2 Estimated Cost at Completion . These blocks shall present thecontractor ' s r ange of estimated costs at comp lerion . The range of e stimatesis intended to allow contractor management flexibility to express possibl ecost outcomes. Contract ors shall provide t he most accurate Estimates atCompletion (EACs) possible through program-level assessments of factors that
may affect the cost , sched ule , or technical outcome of the contract. Suchprogram- l evel assessments shall i n clude consideration of known or ant i c ipatedrisk areas , and p lanned risk reductions or cost containment measures . EACs
shall be reported without regard to contract ceiling .

4101

DI-MGMT- 81466A

2 . 2 . 2 . 1 Management Estimate at Completion - Best Case . Enter in Block 6 . a . lt he contractor ' s best case EAC . The best case estimate is the one that
results in the l owest cost to the Government . Th i s est i mate s hal l be based on
the outcome of the most favorable set of circumstances . If this estimate isd iffe r ent from the most likely EAC (Block 6 . c . l) , t he assumptio ns , c o nditio ns ,and methodology underlying thi s est i mate shall be explained bri e f l y i n Format
5 . This estimate is for informat ional purposes only ; it is not an official
company estimat e . There is no r e quirement for the contract or to p repare andmaintain backup data beyond the explanation provided in Format 5 .
2 . 2 . 2 . 2 Management Estimate at Completion - Worst Case . Ent er in Block 6 . b . l
the contractor ' s worst case EAC . The worst case estimate is the one that
results in the hi ghes t cost t o the Government. This estimate shal l be basedon the outcome of the least favorable set of circumstances . I f this est imate
is d ifferent from t he most likely EAC (Block 6 . c . l ), the assumpt ions ,condit ions , and met hodology underlying this estimat e shall be e xpla i ned
briefly in Format 5 . This estimate is for informational purp oses only ; it is
not an official company est imat e . There is no requirement for the contractort o p repare and ma i nta i n backup data beyond the exp lanation p rov i ded i n Format
5.
2 . 2 . 2 . 3 Management Estimate at Completion - Most Likely . Enter i n Block
6 . c . l t he contractor ' s most li kely EAC . This est imat e is the contractor ' s
official contract EAC and , as such , t akes precedence over the estimatesp resented in Column (15) of Format s 1 and 2 and Block s 6 . a . l and 6 . b . l . ThisEAC is the value that t he contractor ' s management believes is the most l i kely
outcome based on a knowledgeable es t imate of all author i zed work, known risks ,and p robable future conditions . This value need not agree with the total of
Column (1 5 ) (Block 8 . e) . However , any difference shall be explai ned i n Format
5 in such terms as risk, use of Management Reserv e (MR) , o r h i gher management
knowledge of current or fut ure cont ract cond itions . The assumpt ions ,conditions , and met hodology underlying this estimate shall be e xpla ined
briefly in Format 5 . This EAC need not agree with EACs contained in thecontractor ' s internal data, but must be reconcilable to t hem . The most likely
EAC shall a lso be reconcilable to the contractor ' s l atest statement o f funds
required as rep orted in the CFSR, or its equivalent , if this report is acontrac tual requirement.
2 . 2 . 2 . 4 Cont ract Budget Base . Enter in Block 6 . c . 2 the total of negotiatedcost (Block 5 . b) and es t imated cost o f authorized , unpriced work (Blo ck 5 . c) .
2 . 2 . 2 . 5 Variance . Ent er in Block 6 . c . 3 the Contract Budget Base (Block
6 . c . 2) minus the most likely est imate at complete (Bl ock 6 . c . l ) . This value
shall be explained in Format 5 according to applicable contractual
requirement s .
2 . 2 . 3 Authorized Contractor Representative . Enter in Block 7 . a the name of
the authorized per son (program manager or des ignee ) signing t he r eport . Enter
that person ' s title in Block 7 . b . The authorized person shall sign in Block
7. c . Ent er the date signed in Block 7 . d . Electronic signatures areencouraged .
2 .2.4

Pe rformance Data .

2 . 2 . 4 . 1 Column (1 ) - Work Breakdown Structure Element . Enter in Column (1)o f Bl ock 8 . a the noun descr ipt ion of the CWBS i tems f or which c ost i n f ormatio n
is being reported . CWBS elements and levels reported shall be those specified
in the cont ract .
(See f . 1 above . )5102

DI-MGMT- 81466A

2 . 2 . 4 . 2 Cost of Money . Enter i n Columns (2 ) through (1 6 ) of Bl ock 8 . b the
Facili t ies Capital Cost of Money applicable t o the cont ract .
2 . 2 . 4 . 3 General and Administrative . Enter in Columns (2) through (1 6 ) of
Block 8 . c t he approp riate General and Administrative (G&A) costs . I f G&A
costs have not been included i n the CWBS costs reported in Block 8 . a above ,G&A shall be shown as an add entry in Block 8 . a . If G&A costs have been
include d i n the CWBS cos t s reported in Block 8 . a above , G&A shal l be shown asa non- a dd entry in Block 8 . c with an approp riate notation to that eff ect . For
contracts t hat require CCDRs , contractors may also have t o submit separatec osts wit hout G&A for the CWBS elements repo r ted i n Block 8 . a o n an exc eption
basis if the Government specifies such a requirement in the CDRL . I f a G&Aclass ification is not used, no entry shall be made o t her than a n appropriate
notat i on to that effect .
2 . 2 . 4 . 4 Undistributed Budg et . Ent er the a mount of budget appl ica ble t ocontract effort that has not yet been identified to CWBS elements at or be lowt he reporting level . For example , if contract changes were authorized late in
the repo r t ing period, they should have receiv e d a total budget ; however,assignment of work and allocation of budgets to individual CWBS elements may
not have been accomp lished as of the contract or's accounting peri od cutof f
d ate . Budgets that can be i d ent ified to CWBS elements at or bel ow thespecified reporting level shall b e included in the total budgets shown fo r the
CWBS elements in Block 8 . a and shall not be shown as Undistributed Budget(UB) . Ent er in Column (1 5 ) of Block 8 . d the EAC for the scop e of work
represent ed by the UB in Column (14) of Block 8 . d . Ent er in Column (1 6) of
Block 8 . d the vari ance , if any , and fully explain i t i n Forma t 5 . The
reason(s ) for UB shall be fully exp lained in Format 5 .
2 . 2 . 4 . 4 . 1 Use of Undi stributed Budget . UB is use d t o accommodate temporary
situations where time const raints prevent a de q uat e budget planning or wherecont ract effort can only be de fined in very general t erms . UB shal l not be
used as a substitute for a d equate contract planning . Formal budgets shall beallocat ed t o cont ract effort and responsible organizations at t he earliest
p ossi b le t ime , preferably wit hin the next reporting period .
2 . 2 . 4 . 5 Subt o t al (Performance Measurement Baseline) .
In Columns (2 ) t hrough(16) of Blocks 8 . a th r ough 8 . e , enter the sum of the costs and budgets f ordirect , indirect , cost of money , and G&A . This subtotal represent s thedolla rs in the allocated budget (less MR), whi ch is t he Performanc e
Measurement Baseline (PMB) against which performance is measured .
2 . 2 . 4 . 6 Management Reserve . MR is an amount o f the overall contract budget
withheld for management control p urposes and is held for program unknowns(real i zed r i sks on author ized work scope) . Reserve is held f or f uture needs
and shall not be us e d t o offs et cumulat i v e cost var i ances . It shal l not be
eliminated from contract prices by the Government during subsequent
negotiat ions nor used t o absorb the cost o f contrac t changes . I n Column (14 )of Block 8 . f enter the total amount of budget i dentified as MR as of the endof the current report ing period . The amounts shown as MR in Formats 1 , 2 , and3 should agree . Amounts of MR appl i ed to CWBS elements dur i ng the r e port ing
p eriod shall be listed in Block 6 . b of Format 3 and explained in Format 5 .
2 . 2 . 4 . 6 . 1 Negat i ve Management Reserve . Negative entries shall not be ma de inManagement Reserve (Column (14 ) of Block 8 . f ). There is no such thing as" negative MR ." If the contract i s budgeted in e xcess of the Cont ract Budget
Base (the negotiated contract cost plus the estimated cost for aut horized,
unpriced work) , t he provisions applicable t o formal reprogramming and theinst r uct i ons i n paragraphs 2 . 2 . 5 . 1 , 2 . 2 . 6 . 6 , 2 . 2 . 6 . 7 , and 2 . 4 . 1 . 7 apply .

6103

DI-MGMT-81 466A

2 . 2 . 4 .7 Total . Enter the sum of all direct , indirect , cost of money , and G&A
c osts , and UB and MR (if appl icable) i n Col umns (2) through (1 4) of Bl ock 8 . g .
The Total lines of Format 1 (Block 8 . g ) and Format 2 (Block 5 . g) should agree .
The t o t al of Column (14) , Block 8 . g , should e qual the Total Al l ocated Budget
shown in Block 5 . f on Format 3 .
2.2. 5Reconciliat ion t o Contract Budget Base .

2 . 2 . 5 . 1 Formal Reprogramming . In except ional cases , t he contractor may
establi sh performance me asurement b udgets t hat exceed the Cont r act Budget
Base . Acceptance of t he new baseline in excess of t he Contract Budget Basewill be pre d icated on Government approval . This p r ocess is cal l ed f ormalr eprogramming . The contrac tor and the Government shall agree o n h ow theresults of a formal reprogramming will be reported in t he CPR before theforma l r eprogramming is init iated . This agreement and any o t her pertinentdetails on t he reporting of the formal reprogramming shall be incl uded inFormat 5 . Blocks 9 . a and 9 . b are used to reconcile t he higher performancemeasurement budgets , al so called an " over t arget baseline," t o the Contract
Budget Base .
(See 2 . 2 . 6 . 6 , 2 . 2 . 6 . 7 , 2 . 4 . 1 . 7 , and 2 . 6 . 5 below f or more
informat ion on r eporting over t arget baselines (Formal Reprogrammi ng ).)2 . 2 . 5 . 2 Variance Adjustment . In a formal reprogramming (over t arget
baseline), the contract or may :(1) apply t he a dd itiona l budget to c ompl e t e dwork , thereby eliminat ing some or all of t he exist ing cost or schedu l evariances , (2 ) apply the additional budget to remaining work , (3 ) apply someof the additional b udget to completed work and some t o rema i n i ng work , and/or(4 ) apply some of the additional budget to MR .
If t he contractor uses a
port ion of the addit ional budget to eliminate var i ances applicable t ocompleted work , t he t o t al a d justments made to t he cost and schedul e variances
shall be shown in Columns (10) and (11 ) of Block 9 . a . The total cost variancea d jus tment entered i n Column (11 ) of Block 9 . a should be the sum o f theindividual cost variance adjustments shown in Column (1 2 ) of Block 8 . g .
2 . 2 . 5 . 3 Tota l Co ntract Var i ance.
In Columns (10) and (11) of Block 9 . b ,enter the sum of t he cost and schedule variances shown on the Tota l l ine(Block 8 . g ) and on the Variance Ad justment line (Block 9 .a). I n Column (1 4)enter the Contract Budget Bas e from Block 6 . c . 2 . I n Column (1 5) enter t he
management EAC from Block 6 . c . l . In Column (16) of Block 9 . b enter thed ifference betwe en Columns (1 4) and (15) o f Block 9 .b.
2 . 2 . 6 Columns (2) Through (16 ). When compliance with the ANSI/EIA-74 8(current version i n effect at time of contract award) is contractual ly
required, the data in Columns (2) through (16) shall reflect the outp ut of thec ontrac tor ' s ANS I /E IA- 748 comp liant integrated management system .
2 . 2 . 6 . 1 Column (2 ) and Column (7) - Budgeted Cost - Work Schedul ed . For thetime period ind ica t ed, enter the Budget ed Cost f o r Work Scheduled (BCWS) in
these columns .
2 . 2 . 6 . 2 Column (3) and Column (8) - Budgeted Cost - Work Pe rformed . For t hetime period indicated, ent er t he Budgeted Cost for Work Perfor med (BCWP ) i n
t hese c o lumns .
2 . 2 . 6 . 3 Column (4) and Column ( 9 ) - Actual Cost - Work Performed . For thetime period ind ica ted , enter the Actual Cost of Work Performed (ACWP) without
regard t o ceiling . In all cases , cost s and budget s shall be reported on acomparable basis .

7104

DI-MGMT-81466A

2 . 2 . 6 . 4 Column (5) and Col umn (1 0) - Vari ance - Schedule (i . e . ,accomplishment ). For t he t ime period indicat ed, these columns reflect thed i fferences between BCWS and BCWP . For the current period column , Col umn (5 )(schedule variance ) is derived by subtracting Column (2 ) (BCWS ) from Column(3) (BCWP) . For the cumulative t o date column , Column (10) (schedul evar i ance) is derived by subtracting Col umn (7 ) (BCWS) from Column (8 ) (BCWP) .
A positive number in Column (5) and Column (10 ) indicat es a favorable
var i ance . A negative number (indi cat ed b y parent heses) ind i cates anunfavorable variance . Significant variances as specified in the contract
shall be fully explained in Format 5 . If t he contract does not speci fy
var i ance analysis t hresholds , t he contractor shall p r ovi d e appr opriate
variance analyses .
(See 2 . 6 . 3 below .)2 . 2 . 6 . 5 Column (6) and Col umn (11) - Vari ance - Cost . For the time period
indicat ed, these columns reflect the difference between BCWP and ACWP . Fort he current period column , Column (6) (cost variance) is de rive d bysubtracting Column (4) (ACWP ) from Column (3 ) (BCWP ) . For the cumul ative to
dat e column, Column (11) (cost variance ) is derived by subt ract ing Column ( 9 )(ACWP) from Column (8) (BCWP) . A p os itiv e va lue i ndicat es a favorable
variance . A negative value (indicated by p arentheses ) ind icates anunfavorable var i ance . Sign ificant variances as specified in the cont ractshall be fully exp lained i n Format 5 . I f the contract does not specify
variance analysis t hresholds , t he contractor shall provide appropri ate
var i ance analyses .
(See 2 . 6 . 3 be low.)
2 . 2 . 6 . 6 Column (12a ) and Column (12b) Reprogramming Ad j ust ment s - Cost
Variance and Sched ule Var i ance . Fo rmal reprogramming (over t arget baseline )results in budget allocations in excess of the Contract Budget Base and, insome instances , a d jus tment s t o previously reported variances . I f p revi ous ly
reported variances are be i ng ad j usted , the ad j ustment applicable to eachreporting line i t em affected shall be ent ered in Column (12a) i f fo r a costvar i ance and Column (12b) if for a sched ule vari ance . Th e total o f Col umn(12a) and Column (12b) should e q ual the amount shown on the Variance
Adjustment line (Block 9 . a ) in Column (10) and Column (11) .
2 . 2 . 6 . 7 Column (13) Reprogramming Adjustments - Budget . Enter the total
a mounts a dd e d t o the budget for each r eporting line i tem as the r esult o fformal reprogra mming (over ta rget baseline) . The a mounts shown shal l consistof the sum of t he budgets used to a d just cost variance s (Column (1 2) ) plus thea dd itiona l budget a dd e d t o the CWBS e l e ment for remaining work . Enter theamount of budget added to MR in the space p rovided on the Management Reserveline (Block 8 . f of Column (13)) . The t otal of Column (13) should equal theb udget amount by wh i ch the Tota l Allocated Budget exceed s the Cont r act Budget
Base as shown in Block 5 . g of Format 3 . An explanation of the reprog ramming
shall b e provi ded in Fo rmat 5 .
2 . 2 . 6 .7. 1 Formal Reprogramming Reporting . Columns (12) and (13) are intende dfor use only in sit uations i nvolvi ng formal reprogramming (over target
baseline ) .
Internal replanning actions within the Contract Budget Base do not
require ent ries in these columns . Where cont ract ors are submitting CPR datad irectly from automated systems , the addition of Columns (1 2) a nd (1 3) asshown may not be practical due to computer reprogramming problems or space
limitations . In such cases , the i nformation shall be provide d i n Format 5 .
Contracto rs sha ll not be r e quired t o abandon or modi fy ex i sting automatedreporting systems t o include Columns (12 ) and (13 ) if significant costs wil l
be associat ed wit h such c hange . Nor shall contract ors be required to prepare
the report manually solely to include this information .

8105

DI-MGMT- 81466A

2 . 2 . 6 . 7 . 2 . Formal Reprogrammi ng Timeliness . Formal reprogramming (overtarget baseline) can be a significant undertaking that may require more than amonth to implement . To preclude a disrupt ion of management v i sibi l i ty caused
by a reporting hiatus , formal reprogramming shall be implement ed
expedi tiously . If a reporting hiat us is needed, the contract or and theGovernment shall agree on the date and durat ion of the hiatus before theformal reprogramming is initiat ed .
2 . 2 . 6 . 8 Column (14) - At Completion - Budgeted . Enter the budgeted cost atcompletion for the i t ems list ed in Column (1 ). This entry sha l l consist of
the sum of the ori g i nal budgets plus or mi nus budget changes resul t i ng fromcont ract changes , internal replanning , and application of MR . The total(Block 8 . g) should equal the Total Allocated Budget shown in Block 5 .f on
Format 3 .
2 . 2 . 6 . 9 Column (15) - At Completion - Estimated. Enter the latest revised
estimate of cost at completion including estimat ed overrun/underrun for all
authorized work .
If the subtotal (Block 8 . e ) does not agree with the mostl ikel y management EAC (Block 6 . c . l) , the difference shall be explained i nFormat 5 .
(See 2 . 2 . 2 . 3 above . )2 . 2 . 6 . 10 Column (16) - At Complet ion - Variance . Enter the difference
between the Budgeted - At Completion (Column (14) ) and the Estimated - At
Comple tion (Column (15)) by subtract ing Column (15) from Column (1 4) . A
negative value (indicated by parentheses ) reflects an unfavorable variance .
Significant variances as specified in the contract shall be fully explained i nFormat 5 . If the contract does not specify variance analys i s thresholds , thecontractor shall provide appropriate variance analyses .
(See 2 . 6 . 3 bel ow .)2 .3
2 .3. 1

Format 2 - Organ i zational Categories .
Performance Data .

2 . 3 . 1 . 1 Column (1) - Organizat ional Category .
In Block 5 . a list theorgani zat i onal categories that reflect the contractor ' s interna l managements truc ture . This format shall be used to collect organizational cost
information at the total contract level for organ iza tional elements r ather
than for i ndividual CWBS elements . This column shall also i dentify each ma j or
subcontractor as defined in the contract . The individual subcontractor line
shall reconcile wit h the cost t o the pr i me (includes subcontractor fee , MR,
UB , G&A , cost of money , e tc . ) or shall t rack directly with t he subcontractor
submittal consistent with the company/program documented process for
subcontract integrat ion . The process for subcontract integration shal l be
explained in Format 5 . This column shall also identify each major
subcontract or and each ma j or vendor separat ely as an add item .
(Note : The
separat i on of subcontractor efforts is for reporting purposes a nd not intended
to impact how contracts are managed .) Except for mat erial included in the add
i tem for each major sub contrac t or or ma j or vendor , the column shal l a l so
identify mat erial separately as an add item . The level of detail to bereported normally will be limited t o the organizational leve l immediately
under the operating head of the fac ilit y . The contractor may r epo r t thi s
information according to its own internal management structure . If thecontractor is organized b y product teams , t his format may not be needed
because i t may resemble Format 1 .
2 . 3 . 1 . 2 Cost of Money . Enter in Columns (2) t hrough (16) of Block 5 .b the
Facilities Capit al Cost of Money applicable to the contract .

9106

DI-MGMT- 81466A

2 . 3 . 1 . 3 General and Administrat ive . Enter in Columns (2) through (16) of
Block 5 . c t he appropriate G&A costs . If G&A cost s have not been included in
the CWBS cost s reported in Block 5 . a above , G&A shall be shown as a n add entry
in Block 5 . a . If G&A costs have been include d in the CWBS costs reported in
Block 5 . a above , G&A shall be shown as a non- add entry in Block 5.c wit h an
appropr i ate notat i on to that effect . If a G&A c lassificat i on is not used, no
ent ry shall be made other t han an appropriate notat ion to t hat effect .
(See
2 .2. 4 . 3 abov e . )2 . 3 . 1 . 4 Undistributed Budget . Ent er in Column (14) of Block 5 . d t he budget
applicable to cont ract effort that cannot be p lanned i n sufficient detai l to
be assigned to a res p onsible organizational area at the rep orting l evel . Thea mount shown on t his format may e xceed the amount shown as UB o n Format 1 i fbudget i s identified to a task at or be low the CWBS reporting l e v e l but
organizat ional identification has not been made ; or may be less than thea mount on Format 1 where budgets have been assigned t o organizations but not
to CWBS elements . Ent er in Column (1 5 ) of Block 5 . d the EAC for t he scope ofwork represented by t he UB in Column (14 ) of Block 5 . d . Enter in Column (1 6)of Block 5 . d the variance , i f any, and fully exp lain it in Format 5 .
(See
2 . 2 . 4 . 4 above .)2 . 3 . 1 . 5 Subtotal (Performance Measurement Baseline) . Enter the sum of thedirect , indirect , cost of money , and G&A cost s and budgets in Columns (2 )t hrough (16) of Blocks 5 . a through 5 . e .
(See 2 . 2 . 4 . 5 above . )2 . 3 . 1 . 6 Management Reserve .
In Column (1 4) of Block 5 . f ent er t he amount ofb udget i d ent ified as MR . The Management Reserve ent ry shoul d agree wi th theamounts shown in Formats 1 and 3 .
(See 2 . 2 . 4 . 6 above . )2 . 3 . 1 . 7 Tota l . Enter the sum of all d i rect , ind irect , cost of money, and G&A
costs and budgets , UB, and MR (if applicable ) in Columns (2 ) through (1 4) of
Block 5 . g . The t ot als on t his page should equal the Tota l line o n Format 1 .
The total of Column (14) should e qual the Total Allocated Budget shown in
Block 5 . f on Format 3 .
2 . 3 . 2 Columns (2 ) Through (16) . The instructions a pplicable to these columns
are t he same as t he ins t ruct ions f o r corresponding columns on Forma t 1.
(See
2 . 2 . 6 and 2 . 2 . 6 . 1 through 2 . 2 . 6 . 10 above . )2 .4

Fo rmat 3 - Baseline .

2 .4. 1

Cont ract Data .

2 . 4 . 1 . 1 Original Negotiated Cost . Enter in Block 5 . a the dollar value(excludi ng fee or profit) negotiated i n t he original contract . For a c ost
plu s fixed fee , incent i ve , or awa r d fee contract , enter the est i mated cost
negot iated. For an incentive contract , ent er t he definit ized contract target
cost .
2 . 4 . 1 . 2 Negotiat ed Contract Changes . Enter in Block 5 . b t he cumulat ive cost(excluding fee or profi t) applicable to d efinitized contract changes that haveoccurred since the beginning of the contract .
2 . 4 . 1 . 3 Current Negotiated Cost . Ente r i n Bloc k 5 . c the sum of Blocks 5 . aand 5 .b. The amount shown should e qual t he current dollar value (excluding
fee or p rofit) on which contractual agreement has been r eached and should be
the same as the amount in Negotiated Cost (Block 5 . b ) on Format 1 .

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DI-MGMT- 81466A

2 . 4 . 1 . 4 Est imated Cost o f Authorized , Unpr i ced Work . Enter i n Bl ock 5 . d theest imat ed cost (exclud ing fee or profit) for cont ract changes for whi chauthorizat ion has been received from the contract i ng officer , but f or which
contract prices have not been incorporated in the contract , as shown in Block
5 . c of Format 1 .
2 .4. 1.5
5 .d .

Cont ract

Budget Base .

Ent er in Block 5 . e the sum of Block s 5 . c and2 . 4 . 1 . 6 Total Allocated Budget . Ent er in Block 5 . f the sum of all budgets
a llocated t o the performance of the c ont ractual effort . The amount shownshall include all MR and UB . This amount shoul d be the same as that shown on
the Total line in Column (14) on Format 1 (Block 8 . g ) and Forma t 2 (Block
5 . g) .
2 . 4 . 1 . 7 Difference . Ent er in Block 5 . g the difference between Blocks 5 . e and
5 .f .
In most cases , the amounts shown in Block s 5 . e and 5 . f wil l be
ident ical .
If the amount shown in Block 5 . f exceeds that shown in Block 5 . e ,i t usually i s an i ndication of a formal reprogramming (ov er target basel ine) .
The difference shall be explained in Format 5 at the time the negative value
appears and sub sequently for any changes in the d iffe rence betwee n Contract
Budget Ba se and t he Total All ocated Budget .
2 . 4 . 1 . 8 Contract Start Date . Enter in Block 5 . h the date the contract o r was
authorized to s tart work on the contract , regardless of the date of contract
defini t izat ion .
(Not e : Long-lead procurement effort s authorized under p riorc ont racts a re not t o be c onsidered . )2 . 4 . 1 . 9 Contract Definitization Date .
contract was definit ized .

Ent er in Block 5 . i the date t he

2 . 4 . 1 . 10 Planned Completion Date . Enter in Block 5 .j the completion date towhich the budget s allocated in the PMB have been planned . This daterepresents the planned completion of all significant effort on the contract .
The cost associated wit h the schedule from whi ch thi s date i s taken is t he
Total Allocated Budget (Block 5 . f of Format 3 ) .
2 . 4 . 1 . 1 0 . 1 Performance Me asu rement Schedule Incons i stent Wit h Contractual
Schedule . In e x cep tional cases , the contractor may determine that thee xisting contract schedule cannot b e achieved and no longer represents areasonable basis for management control . With Government app roval, thecontractor may rephase i ts performance measurement schedule t o new dates thatexceed the contractual milest ones , a condition known as " over target
schedule ." These new dates are for performance measurement purposes only anddo not represent an agreement t o mo dify t he contract terms and conditions.
2 . 4 . 1 . 10 . 2 Over Target Schedule Ag reement . The Government and the contractor
shall agree on the new performance measurement schedule p ri or to reporting itin the CPR . The contractor shall p rovide pertinent information in Format 5 on
any schedule milest ones t hat are inconsistent with cont ractual milestones ,beginning the mont h the schedule i s implemented and each month therea f t er .
2 . 4 . 1 . 1 0 . 3 Ind i cat o rs of a Performance Measurement Schedule I ncons i stent With
the Cont ractual Schedule . Formal reprogramming o r i nternal replann i ng may
result in performance measurement milestones that are inconsistent wi th thecontractual milestones (Over Target Schedule) . A d ifference between theplanned completion date (Block 5 . j) and the contract completion date (Bl ock5 .k) usually ind icates that some or all of the performance measurement
milestones are i ncons ist ent wit h the contract ual milestones .

11

108

DI-MGMT- 81466A

2 . 4 . 1 . 11 Contract Completion Date . Enter in Block 5 . k the contract scheduled
complet i on date in accordance wi th the lat est contract modification . The costassociated with the schedule from which this date is taken is t he Contract
Budget Base (Block 5 . e of Format 3) .
2 . 4 . 1 . 12 Estimated Completion Date . Enter in Block 5 . 1 the contractor ' s
lat est revised estimated completion dat e . Thi s dat e represents the est i matedcompletion of all significant effort on the contract . The cost associatedwith the schedule from which this date is taken is the " most likely"
management EAC (Block 6 . c . 1 of Format 1) .
2 . 4 .2

Performance Data .

2 . 4 . 2 . 1 Column (1 ) - Performance Measurement Baseline (Beginn ing of Period) .
Ent er in Block 6 . a the time- phased PMB (including G&A) that existed at the
beginning of the current reporting period . Most of the entries on t his line
(e . g . , for Columns (4) through (9)) are taken directly from the PMB (End of
Per i od) l i ne on the previous report . For example , the number in Col umn (4) on
the PMS (End of Period) line from the last report becomes the number in Column(3) on the PMB (Begi nning of Period) line on this report . The numbe r inColumn (5) (End of Period) last report becomes Column (4) (Beginni ng of
Period) on thi s report , etc . (if each of the t wo columns covers the samelengt h of t ime ).
2 . 4 . 2 . 2 Baseline Changes .
In Block 6 . b , list all significant baselinechanges that have occurred during the report ing per i od . Thi s l i sting shall
include the contract changes and supplemental agreements authorized during thereporting per i od, allocations from MR and UB , and any s i gni f icant rephasing o fbudget s . All s i gnificant authorized baseline changes shall be l isted whether
priced or unpriced .
2 . 4 . 2 . 3 Performance Measurement Baseline (End of Period) . Enter in Block 6 . cthe time-phased PMB as it exists at the end of the reporting period . Thed i fference between thi s l i ne and the PMB (Begi nning of Period) rep r esents theeffects of all significant changes , includ ing the authorized changes ,allocations of MR made during t he per i od, and changes t o time phasing due tointernal replanning or formal reprogramming . The reasons for these changes
shall be explained in Format 5 .
2 . 4 . 2 . 4 Management Res erve . Enter in Block 7 the total amount of MR
remaining as of the end of the reporting period . This value should agree withthe amounts shown as MR in Formats 1 and 2 .
2 . 4 . 2 . 5 Total . Enter in Column (16) of Block 8 the sum of Column (16) of
Block 6 . c (PMB (End of Period)) and Column (16) of Block 7 (Management
Reserve ) . Thi s amount should be the same as that shown on the Total line
(Block 8 . g) in Column (14) on Format 1 .
2 . 4 . 3 Column (2 ) - BCWS - Cumulative To Date . On the PMB (Beginning of
Per i od) l i ne (Block 6 . a) , enter the cumulative BCWS as of the f i rst day of thereporting period . This should be the same number reported as BCWS Cumulat ive To Dat e on t he Tot al l i ne (Column (7) of Block 8 . g) of Fo r mat 1 ofthe previous CPR . On the PMB (End of Peri od) l i ne (Block 6 . c) , ente r the
cumulative BCWS as of the last day of the reporting p eriod . This should bet he same number reported as BCWS - Cumulative t o Date on the Total l ine(Column ( 7 ) of Block 8 . g) of Format 1 for this CPR .

12

109

DI-MGMT-81466A

2 . 4 . 4 Column ( 3 ) - BCWS For Report Perio d . On the PMB (Beginning of Period)
line (Block 6 . a ), ent er t he BCWS planned for the report ing period . Thisshoul d be the number i n Column (4) on the PMB (End of Peri od) l i ne (Bl ock 6 . c)on the previous CPR .
2 . 4 . 5 Columns (4) Th rough (1 4 ) . Enter t he names of e ach month for thecontract period of performance in t he head ings of each of the Columns (4)through (9) , and the names of the approp riate periods in the headings o f eachof the Columns (1 0 ) through (14) of Block 6 . Columns beyond (1 4) may be added
when necessary or desirable .
In the PMB (Beginning of Period) l ine (Block
6 . a ) , enter t he BCWS p r oj ect i on repo r t ed i n Format 3 of the p r evious CPR as
PMB (End of Period) (Block 6 . c) . In the PMB (End of Period) l ine (Block 6 . c )o f this report , ent er t he projected BCWS by month for t he next six months a ndfor periodic i ncrements (mont hly , quarterly , or annually) thereafter f or theremainder of the cont ract. The t ime phasing of each i t em li sted in Column (1 )of Block 6 . b need not be shown i n Columns (4) t hrough (14) . It is useful toshow the time phasing of any baseline changes .
(Not e : For the p urposes ofillustrat ion , Sample Format 3 has Columns (4 ) t hrough (14) fo r reporting BCWS .
The act ual number of columns will vary from contract to contract . )2 . 4 . 6 Column (15) - Undi s tributed Budg et. On the PMB (Beginning of Period)
line (Block 6 . a) , enter the number from Column (1 5 ) on the PMB (End o f Period)
line (Block 6 . c ) from t he previous CPR . On t he PMB (End of Period) line ,enter t he UB shown i n Column (14 ) of Block 8 .d on Format 1 of this report .
2 . 4 . 7 Column (16) - Total Budget . On the PMB (Beginning of Period) line
(Block 6 . a) enter t he number from Column (1 6) on the PMB (End of Period) li ne(Block 6 . c ) from the previous CPR .
In the section where baseline chang es that
occurred during t he period are listed (Column (1) of Block 6 . b) , enter thea moun t of each of the changes listed. On the PMB (End of Period) l i ne (Block
6 . c ), ent er t he sum of the amounts in t he preceding columns on this line . Ont he Management Rese rve line (Block 7) , enter the amount o f MR avai lable a t theend of the period . On the Total line (Block 8 ) enter the sum of t he amounts
in this column on t he PMB (End of Period) line and the Management Reserveline .
(Note : Thi s should e qua l the amount in Block 5 . f on this fo rmat andalso the amount of the Total line in Column (14) , Block 8 . g , of Format 1.)
2 .5

Fo rmat 4 - Staff i ng .

2 . 5 . 1 Performance Data . For t hose o rganizationa l categories shown in Column(1 ) of Block 5 , e q uivalent months shall be indicated for the current reporting
period (Column (2) ), cumulative t hrough t he current period (Column (3) ),forecast to completion (Columns (4) t hrough (14)) , and at compl et i on (Co lumn(15)) . Direct equivalent months shall be shown for each organizational
category for the contrac t. An equiva l ent month is defined as the e f fo r t e qu a lto that of one person for one month . Values shall be reported i n whol enumbers .
(Note : Partial months , . 5 and above , shall be rounded to 1 ; below. 5 to 0 . ) When t he Government and the contract or agree , staf f i ng may bereported in equivalent days or hours .
2 . 5 .1. 1 Column (1) - Organizational Categor y .
I n Block 5 , list theorganizational categories that reflect the contractor ' s internal management
structure . Format 4 categories may d if fer from t hose reported i n Format 2 .
If the Government need s d i fferent categori es i n Formats 2 and 4 , t h e Format 4
cat egories shall be a ddressed during negotiat ions .
(See f . 4 above . )2 . 5 . 1 . 2 Total Direct .
In Block 6 , Columns (2 ) through (1 5 ), enter the sum of
all direct equivalent months for the organizational categories shown in Column( 1) .

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DI- MGMT-81466A

2.5.2 Column (2 ) - Act ual - Current Period. En t er the actu al equivalen tmonths incurred d uring the current reporting period .
2 . 5.3 Column (3 ) - Actual End of Current Period (Cumulative) . Enter theactual equivalent months incurred to date (cumulative) as o f the end o f thereporting pe riod.
2 . 5 . 4 Columns (4) Through (14) - Forecast (Non - Cumulative ) . Enter the namesof each month for the contract period of perfo rmance in the headings of eachof the Columns (4) through (9) , and the names of the appropriate periods i n
the heading s of each of the Columns (10 ) through (14) of Block 5 . Enter asta ffin g forecast by month for the next six months and for per i odic i ncrements{mo nthly, quarterly , or annually) thereafter for the remainder o f thecontract. The staffing forecast shall be updat ed as part of the formal E.AC
process followed by the contractor . The s t affing forecast shall ref l ect thesame staffing estimate us e d as the basis for the EAC i n Column (15 ) on both
Format 1 and Format 2.
(Note : For the purposes of illustra t ion , Sample
Format 4 has Columns (4) through (1 4) for reporting s taffing forecast . The
actual number of columns will vary from contract to contract .)2.5 . 5 Column (15) - Forecas t at Completion . Enter the estimate of equivalentmonths necessary for the total contract in Column (15 ) by organiz ational
category. Th is estimate shall be consistent with the "most likely" management
EAC shown in Column (15 ) of Block 8 . e of Format 1 . Any significant change l n
the total number of e qu ivalent months at completion of the cont ract (i. e .,Column (15) Total) shall be explained in Format 5.
2.6

Format 5 - E:xplanations and Problem Analyses .

2 . 6 . 1 General . Format 5 , Explanations and Problem Ana ly ses , is a narrative
report prepared to amplify and explain data in the o t her CPR f ormats . Format
5 shall normally address the following :(1) contractually req u ired cost ,schedule, and EAC variance analyses, (2 ) MR changes and usage , (3) UB
contents , (4) d i fferences between the bes t case, worsr case, and most l ike l ymanagement EAC , if any , ( 5 ) the difference between the most likely management
EAC a nd t he estimate in Block 8 . e of Column (15), if any, (6) signi f i c an t
d ifferences between begi nning of period PMB time phasing and end o f period PMBtime phasing in Format 3 , (7) performance measurement milestones that areinconsis tent wic:h contractual milestones (Ove r Target Schedule ), ( 8 ) forma lr eprogramming (ove r target baseline ) implementation details , and ( 9)significant staffing estimate changes in Format 4. Any other t opic releva nt
to contract cost , schedule , or technical performance may be addressed in thisformat . The date (s ) of the Integ rated Baseline Review (s ) may a ls o bea ddresse d in this format . Contract ors may elect to attach subcontractor
Format 5 reporting and cross reference this analys i s in the fo rmat 5 report i ng
submitted to the Government to gain t ime efficiencies and meet submission
dates .
2 . 6 . 2 Total Contract . Provide a summary analysis that i dentifies significant
problems af f ecting performanoe .
Indicate c orrectiv e actions required,includ ing Government action where app licable . Significant changes since theprevious report sha ll be highlighted . Discuss any other i ssues affecting
successful attainment of contract c ost , schedule , or technica l obj ec tives thatthe contractor deems significant or not eworthy . This section is brief ,normally one page .
2 . 6 .3 Cost and Schedule Variances . Explain all variances that exceed
specified v aria nce thresholds . Explanations of variances shall c learly

14

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DI-MGMT- 81466A

identify the nature of the p r oblem, s ignificant reasons for c ost or schedulevariance , effect on t he immediate task , impact on t he t ot al contract , and thecorrec tive action t a ken or p lanned. Exp lanations of cost variances shal lidentify amounts attributable to rate changes separately from amounts
applicable to hours worked; a mounts attributable to mat erial p rice changess eparately from amounts appli cable to mater i a l usage ; and a mounts attribut abl et o overhead rat e changes separately from amount s applicable t o overhead basechanges or changes i n t he overhead allocation basis . To r e duce t he volume o fvariance analysis explanations , the contractor may refer to a prior CPR ' svariance analysis explanations if t he explanation for t he current CPR ' s
var i ance has not changed s i gn i f i cant ly . Exp lanations of schedule variances
and the imp act on the contract shall be pe rformed in parallel with theschedule analysis calle d out by the IMS DID . Ac cordingly, there i s ar e quirement in b . above for t he IMS DID , DI -MGMT-8 1 650 , to be used inconjunction with this DID .
(See 2 . 2 . 6 . 4 and 2 . 2 . 6 . 5 above .)2 . 6 . 3 . 1 Setting Variance Analysis Thresholds .
In Fo rmat 5 , the Government
will require only t hat amount of variance analysis that sat isfies it s
manage ment i nformation needs . Excess i v e variance analysis i s burdensome andcostly , and detracts from the CPR ' s usefulness , while too litt le informationis e qua lly undes irable .
2 . 6 . 4 Ot her Analyses .
In addition to variance explanations , the following
ana lyses are mandat ory :2 . 6 . 4 . 1 . Management Est imat e at Complet ion . If t he best or worst casemanagement EACs d i ffer from the most likely est i mate (Column (1) o f Bl ock 6 o f
Format 1 ), a brief explanation of the difference shall be p rovided . Also , i ft he most like ly management EAC diffe rs from the t ot al enter e d i n Column (15)of Fo rmat 1 o r 2 , the d i fference shall be explai ned . The e xpla nations s ha l l
focus on such areas as a knowledgeable , realist ic risk assessment ; projected
use of MR; estimate for UB ; and h i gher management's knowledge o f cur rent or
future contract conditions . The assumptions , cond itions , and methodology
underlying all management EACs shall be explained .
(See 2 . 2 . 2 to 2 . 2 . 2 . 3 ,2 . 2 . 2 . 5 , 2 . 2 . 6 . 9 , and 2 . 2 . 6 . 10 above . )2 . 6 . 4 . 2 Undi s tributed Budget.
I dent ify the effort t o which the UB applies .
Also , expl a i n any var i ance between the UB and t he estimate for UB in Formats 1
and 2 .
(See 2 . 2 . 4 . 4 and 2 . 3 . 1 . 4 above .)2 . 6 . 4 . 3 Management Reserve Changes . I dentify the sources and uses of MRchanges during the report ing period . I dent ify the CWBS and organizational
elements to which MR i s applied , and the reasons for it s appl i c at i on .
(See
2 . 2 . 4 . 6 above . )2 . 6 . 4 . 4 Base line Changes . Expla i n reasons for s i gnificant shift s i n timephasing of the PMB shown on Format 3 .
(See 2 . 4 . 2 . 3 above .)2 . 6 . 4 . 5 Staffing Level Changes . Expla i n significant changes in the total
staffing EAC shown on Format 4 . Also , explain reasons for significant shifts
in t ime phas ing of p lanned staffing .
(See 2 . 5 . 5 above . )2 . 6 . 5 Formal Reprog ramming (Over Target Base line). If t he difference shownin Bl ock 5 . g on Format 3 becomes a negat i ve value or changes i n value , p rov i deinformation on the following :2 . 6 . 5 . 1 Authorization . Procur i ng act i v i t y authorizat ion for the baselinechange that resulted in negat ive value or change .

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DI-MGMT- 81466A

2 . 6. 5. 2

Reason .

A discussion of the reason(s) for the change .

2 . 6. 5. 3

CPR Reporting . A discussion of how the change affected CPR reporting
amount allocated to MR, adjustments t o cost or schedu l e variances ,etc . ) .
(See 2 . 4 . 1 . 7 , 2 . 2 . 5 . 1 , and 2 . 2 . 6 . 7 above . )(i.e . ,2 . 6 . 5 . 4 Schedule . Indicat e whether the cont ract schedule was retained for
performance measurement or was replaced wi t h a schedule that exceeds thecont ractual schedule (Over Target Schedule) .
2 . 6 . 6 Over Target Schedule .
If a performance measurement schedule exceeding
the cont ractual schedule (Over Target Schedule) has been impl ement ed , provide
a discussion of t he pertinent information, such as authoriz at i on , reasons , ands i gnificant dates .
(See 2 . 4 . 1 . 10 . 1 above . )END OF DI - MGMT- 81466A

16
113

ATTACHMENT #10

Department of Health & Human Se,vices
HHS
Office of the Assistant Secretary for Preparedness and Readiness
ASPR
Biomedical Advanced Research and Development Authority
BARDA

7 Principles of Earned ValueManagement
Tier 2
System Implementation
Intent Guide
21 December 2011

ASPR
,r,,u,,•

l\ !it.l!i:J \~T SJlllH,T ,\•l l(•ltl'ltr\1.Jlli\H'> "''P

114

TABLE OF CONTENTSOVERVIEW _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 1
EVM IMPLEMENTATION TIERS _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 3
SEVEN PRINCIPLES OF EVM _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 4

Principle 1: Plan all Work Scope _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 4
Principle 2: Break Work into Finite Pieces and Define Person/Organization Responsible forWork _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 4
Principle 3a: Integrate Scope, Sch edule and Budget into a Performance Measurement Baseline _ _ 5
Principle 3b: Control Changes to the Baseline _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 6
Principle 4 : Use Actual Costs Incurred and Recorded in Accomplishing the Work Perfom1ed

7

Principle 5: Objectively Assess Accomplishments at the Work Performance Level

7

Principle 6a: Analyze Significant Variances From the Plan

8

Principle 6b: Prepare an Estimate at Completion Based on Performance to Date and Work to be
Performed - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9
Principle 7: Use EVMS Information in the Company's Management Processes _ _ _ _ _ _ _ _ 9
APPENDICES _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 11

APPENDIX 1: Glossary of Terms _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 11
Appendix 2 Supplemental EVM Implementation Guideline

21

Appendix 3 Sample EVM Documents

24

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7 Principles of EVM Tier 2 System Implementation Intent Guide

OVERVIEW
Earned Value Management (EVM) is a program management tool, techniq ue, and discipline thatfacilitates systematic planning for and monitoring of, high value, complex projects. It integrates a
project's scope of work with the related budget and schedule to permit detailed assessment ofoverall performance during the life of the project.
Several government-wide guidance documents govern the definition and use of EVM systems.
Guidelines outlining the q ual ities and characteristics of an EVM system are set forth in theAmerican National Standards Institute/Electronic Industries Alliance (ANSIJEIA) Standard-748(most current version). More detailed and specific guidance and direction is contained in 0MB
Circ ular A-1 1, Preparation, Submission and Execution of the Budget, specifically in Part 7 ofthat Circular A-1 1, Planning, Budgeting, Acquisition, and Management of Capital Assets, and its
supplement, the Capital Programming Guide. Based on this collective 0MB guidance, EVMS isintended to be used on those parts of acquisitions th at will involve developmental effort. This
would include not only those acquisitions designated by the agency as major systems but also
those acquisitions that include s ignificant developmental, modification, or upgrade during theoperational or steady-state phase of a program.
The FAR rule on EYMS became effective on July 5 , 2006. Its purpose is to implement EVMS
policy in accordance with 0MB Circular A-11. Because the new FAR coverage applies
throughout the executive branch and to agencies with disparate definitions of and processes andprocedures for major systems acquisitions, the FAR Council decided against a "one-size-fits all"approach and left several significant aspects of the detailed implementation up to the discretion ofeach covered agency.
The FAR and Health and Human Services Acquis ition Regulations (HHSAR) lang uage for
EVMS will be utilized for all construction or Information Technology (IT) projects. Since mostof the acquisitions at the Biomedical Advanced R esearch and Development Agency (BARDA)
are unique in that most acquisitions are not Information Technology projects or construction
projects, BARDA is developing EVM language that incorporates the 7 Principles of Earned
Value M anagement. These principles allow flexibility to an EVM system structure but still meetthe spirit of the ANSI/EIA Standard-748. It also incorporates discipline in implementation andoperations and also provides the same reporting data outlined by 0MB.
The Seven Principles of Earned Value M anagement are as follows:
1. Plan all work scope to completion
2.

Break down the program work scope into finite pieces that can be assigned to a
responsible person or organization for control of technical, schedule and cost objectives

3. Integrate program work scope, schedule, and cost objectives into a performancemeasurement baseline plan against which accomplishments can be measured. C ontrol
changes to the baseline.
4. Use actual costs incurred and recorded in accomplishing the work performed.

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7 Principles of EVM Tier 2 System Implementation Intent Guide

5. Objectively assess accomplishments at the work performance level.
6.

Analyze significant variances from the plan, forecast impacts, and prepare an estimate atcompletion based on performance to date and work to be performed.

7.

Use earned value information in the company's management processes.

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7 Principles of EVM Tier 2 System Implementation Intent Guide

EVM IMPLEMENTATION TIERSBARDA will be implementing a tiered approach to EVM based on the type of acquisition, size ofthe acquisition and the technical readiness level. There are three tiers and they are as follows:

TIER 1
For all construction contracts and IT contracts the ANSI/EJA-748 Standard for Earned ValueManagement Systems will apply and all relevant FAR/HHSAR clauses pertaining to EVMS will
be incorporated in the contract. The National Defense Industrial Association (NOIA) Program
Management Systems Committee (PMSC) ANSVEIA-748 Standard for Earned ValueManagement Systems Intent Guide should be used as guidance.

TIER2
For countermeasure research and development contracts that have a total acquisition costs greaterthan or equal to $25 million and have a Technical Readiness Level (TRL) of less than 7 will
apply EVM principles for tracking cost, schedule and technical performance that comply with the
7 Principles of EVM Implementation.

TIER3
For countermeasure research and development contracts that have total acquisition costs less than
$25 million but greater than $10 million will apply EVM principles for tracking cost, scheduleand technical performance that are consistent with the 7 Principles of EVM Implementation.
This Guide is an explanation of the intent of what is expected for a Tier 2 system implementationof the 7 Principles of EVM.

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7 Principles of EVM Tier 2 System Implementation Intent Guide

SEVEN PRINCIPLES OF EVM
Principle 1: Plan all Work Scope
In a performance measurement system implementation the Statement of Work (SOW) shouldreflect all work that is to be performed. In a 7 Principles implementation a Work Breakdown
Structure (WBS) shall be developed to include all elements of the SOW. The level of the WBS
may not be as detailed as in a Tier 1 implementation. It would be developed at a higher level,such as level three or four, however, the government may expand specific technical legs to lower
than level four and it may retract some non-technical legs to higher than 3. It is beneficial andrequired to develop a WBS dictionary that explains what work is going to be performed in each
WBS in detail. This will ensure that the contractor has identified all work scope and left no major
work undefined. It is recommended that the work packages descriptions are clear and detailed sothat there is an understanding of the work that is to be performed in the work packages. For the 7
Principles implementation programs it would be acceptable for the WBS Dictionary be expanded
to include information that would normally be kept on a Work Authorization Document, such as
charge numbers associated with the work, period of performance, the manager who is responsible
for the work, and budget associated with the WBS. The additional "WAD info" would only be
added to the lowest level (i.e. level 3 or 4) of the WBS. The roll up level WBS would only
include scope. By doing this documentation is limited to one document instead of two.
By developing a WBS and a WBS Dictionary/Work Authorization Document the work scope has
been defined but the documentation is greatly reduced and the costs associated with developing
and updating the documentation is reduced. The intent of the combination document is not to
reduce the level of information provided to the government but to reduce the amount of
documents that need to be produced. An example of a WBS dictionary and Work Authorization
document and what is expected on the document(s) is provided.

Principle 2: Break Work into Finite Pieces and Define Person/Organization Responsible
for Work
In a 7 Princ iples Tier 2 implementation it is recommended that the work be broken into finite
pieces in the schedule tool. It is recommended to plan the work by the lowest level WBS. The
lowest level WBS (level 3 or 4) should be the control account and the activities would act as thework packages. For Tier 2 programs that are of larger value (greater than $25M) the expectationis that the control account will be at least at level 4 and potentially level 5. Most of the normal
functions accomplished when schedul ing will be required on a 7 Principles Tier 2
implementation. These normal functions include, network schedul ing, horizontal and verticaltraceability, forecasting schedule start and completion dates, and running critical path analysis.
As part of vertical traceability it is expected that all contract mjlestones will be listed on theschedule.
The schedule should include but is not limited to include the following fields:
WBS number
Control Account number
Work package number
Task name

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7 Principles of EVM Tier 2 System Implementation Intent Guide

Duration
Baseline Start and Finish Dates
Actual Start and Finish Dates
Forecast Start and Finish Dates
Predecessor/Successors
Activity Percent Complete

All the work scheduled at the lowest level WBS should be identified by a single responsible
manager. This manager, known as a Control Account Manager should be identified in theschedule tool and/or in a cost tool. In a 7 Principles implementation, only individuals at thelowest level WBS need be identified and there is no requirement for the costs to roll up byorganization, although if it is not cost intensive or tool restricted then developing the OBS is
recommended. In many cases, BARDA will provide the top three levels of the WBS for thecontractor to use.

Principle 3a: Integrate Scope, Schedule and Budget into a Performance Measurement
Baseline
This principle integrates the work scope, the schedule and the budget into a performancemeasurement baseline. Since we discussed work scope and schedule the focus of this princ iple isthe incorporation of the budget in a time-phased manner. The budget must be integrated with thescope of work and the schedule into a Performance Measurement Baseline (PMB). The budget ismade up of both direct and indi.rect dollars. An accepted way of incorporating the budget andintegrating with the scope and schedule is to resource load the Microsoft Project (or otherscheduling tool) schedule. This is done by loading the individual people and their loaded rate
into the tool. This budget data will be input at the work package level with a rate that includes
the indirect costs. The budget will have to have the capability to be rolled up to the control
account level and will need to be reported in a way that provides the responsible manager(Control Account Manager) with information needed to manage the program. Resource loadingof the schedule is not the only way to incorporate the budget. As long as the budget in thebudget/EV tool is linked to the schedule activities and it is flexible to change when schedulebaseline dates change, then loading the budget in the Budget/EV tool is an acceptable way tointegrate the cost and schedule baselines. The budget information will be displayed on the timephased Control Account Plan reports. These reports should have the flexibility to report the
dollars both in total dollars, as well as, direct and indirect broken out separately. Also the report
is generally required as a deliverable on most contracts and must have the capability to include
earned value or Budgeted Cost of Work Performed (BCWP) and actual costs or Actual Costs ofWork Performed (ACWP).
Budgeting of subcontractor effort will vary depending on whether or not the subcontractor is acost plus or fixed price subcontract. If it is cost plus then the expectation is that there will bemonthly billing of costs from the subcontractor to the prime contractor and therefore budget must
be planned in accordance with the work completed and billed. If it is fixed price then the budget
should be planned with work execution or milestones completed and budget should only beplanned in those months where work is expected to be completed.

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It is recommended that management reserve and undistributed budget be utilized in the budgeting
process. Undistributed budget is budget that has not yet been distributed to a control account andit requires additional time to plan the work and distribute the budget to a control account. It is atemporary holding account and budget sho uld only stay in U nd istributed Budget for one o r twomonths. If the work scope is easily identified to all the control accounts then the use of
Undistributed Budget may not be necessary.
Management Reserve is budget that is set aside, normally by the Program Manager, to be used tobudget future but currently unknown tasks. It is associated with risk issues and is to be used tomitigate risk. It is not part of the Performance Measurement Baseline and it should not be used
for out of scope work and to cover overruns.

Principle 3b: Control Changes to the Baseline
A properly controlled PMB is crucial to effective program management. The timely and accurate
incorporation of contractual changes ensures that the information generated from the execution of
the baseline plan provides an accurate picture of progress and facilitates correct management
actions and decisions. The accurate and timely incorporation of authorized and negotiatedchanges into the PMB ensures that valid performance measurement information is generated forthe new scope being executed. Near term new scope effort should be planned and have budget incontrol accounts. Far term new scope effort that cannot be reasonably planned in the near term
can either be put in planning packages in the control account or left in Undistributed Budget if thecontrol account has not been identified. The timely and accurate incorporation of authorized andnegotiated changes into the PMB ensures that val id performance measurement information is
generated for the new scope being executed. Budget revisions are made when work is added tothe contract and are traceable from authorized contract target costs to the control account budgets
or from management reserve. Management reserve may be used for future work when additional
in-scope work has been identified.
Retroactive changes to the baseline may mask variance trends and prevent the use of performancedata to project estimates of cost and schedule at completion. Controlling retroactive adjustments,
which should only be made in the current period, if possible, is imperative because they could
arbitrarily eliminate existing cost and schedule variances.
The use of program budget logs sho uld be used to track and log all budget changes. The ability to
track budget values for both the internal and external changes will help in the maintenance of theperformance measurement baseline from program start to completion. Contractor is expected toutilize baseline change documentation facilitating the change. It sho uld provide therationale/justification, approval process, work scope additions or deletions, dollars, changes toschedules, estimate at completion, etc. It should also include contractual change documents forexternal changes, such as a contract modification, letter to proceed, not to exceed letter, changeorder, etc., that transmit and authorize the change or addition to work, budget, and schedule.
Other documents that should change if a change of scope has been authorized is: Statement ofWork, WES (changes if applicable); WBS Dictionary (additions or deletions to scope); work
authorization documents authorizing new scope, schedule and budget; schedules.

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Principle 4: Use Actual Costs Incurred and Recorded in Accomplishing the Work
Performed

Some of the new acquisitions at BARDA will be required to be compliant with the Cost
Accounting Standards. For 7 Principles implementation contractors must utilize a work order/job
order/task code charge number structure that uniquely identifies costs at the control account level.
This will allow for accumulation and summarization of costs to higher levels of the work
breakdown structure. Actual costs are accumulated in the formal accounting system in a mannerconsistent with the way the related work is planned and budgeted. Actual costs reported in theperformance reports agrees with the costs recorded in the accounting system or can be explained
as timing differences. The contractor will have to be able to incorporate and reconcile to theaccounting system actual costs on their Contract Performance Reports (CPR) to the customer.
Depending on the amount of material and subcontractors on the program, it may be necessary forreporting purposes, to include accruals, or estimated actuals, for these costs. Since material andsubcontractor invoices are not paid and recorded in the accounting system for up to several
months after the work has been planned, performance data will be skewed. Accruing or
estimating actual costs based on receipt (for material) and expended hours for subcontractors will
alleviate this issue. The use of accrual/estimated actuals should be reviewed on a case by casebasis depending on the size of program, the amount of material or subcontractor budget and costs.
If the material and subcontract effort on the project is minimal (represents less than 5% of the
project budget) then the time and effort needed to manage the accruals would outweigh thebenefit of having the costs accrued since the performance data would only be minimally affected.
Although actual costs are generally reported to the USG in total dollars the system must be able
to differentiate and report direct costs and indirect costs if requested.
If the subcontractor has a fixed price contract the prime contractor, then the prime contractor must
report actual costs in accordance with the work that is accomplished. This is acheived byrecording the actual costs equal to the work that was performed in the EVM system and on the
CPR. If the subcontractor is a cost plus contract its imperative the costs the prime reports is inaccordance with the costs incurred in that month. This is necessary to ensure that the datareported is not skewed. With this premise, fixed price subcontractors cost variances should notexist or be reported on the CPR whereas the cost reported for cost plus subcontractors should bebased on what was incurred and not what has been invoiced to date, which may be months
behind.

Principle 5: Objectively Assess Accomplishments at the Work Performance Level

In order to meet this Principle, the scheduling of the scope of work in work packages or activities
need to incorporate measurable units or milestones in order to objectively assess
accompl ishments or obtain what we call "earned value". These units or milestones are given a
value based on labor resources needed to accompl ish the work (which becomes the Budgeted
Cost of Work Scheduled or BCWS). When they are accompl ished (known as Budgeted Cost ofWork Performed or BCWP) they receive the value associated with the budget which measuresprogress.

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Schedule status to measure progress needs to be on at least on a monthly basis although it ispreferred on a bi-weekly basis. As part of the status process progress dates, such as actual
start/complete and forecast start/complete need to be updated.
Since Microsoft Project seems to be the schedule tool of choice by most contractors, there are
four types of earned value methodologies utilized by Microsoft Project of which two assess
progress by the completion of milestones and they are the 50/50 and 0/100 methodologies. In
both cases, progress is reported for completion milestones and in the 50/50 methodology fifty
percent of the value of the work package/activity is credited for starting the work. The other two
earned value methodologies are assessed percent complete (also know as Supervisor's Estimate)
and level of effort (LOE). All four methodologies are legitimate earn value measurement
techniques but the assessed percent complete based or supervisor's estimates are highly
discouraged. The reason is that it is highly subjective and is not based on any quantifiable
criteria. BARDA will not accept these earned value methodologies unless approved as an
exception on a case by case basis. If percent complete on work packages is used with objective
measurable activities, the contractor must show distinct relationship between the budget plannedat the work package level and the value earned at the activity level. If this is done properly thenthe measurement will be objective and the schedule variance will be clearly understood and easy
to explain. If this is not done properly then schedule activities are not aligned with the budget in
the performance measurement baseline and schedule variances will not be easy to understand. If
the latter is the case, BARDA will not accept that as an acceptable earned value methodology.
There are built in weaknesses with the 0/100 and 50/50 methodologies also. If the responsible
manager is being asked to plan their work in monthly increments in order to utilize the 0/1 00
methodology then they may be asked to break the work up in pieces that don't make logical senseor represent the natural ending of the work. Also the 50/50 methodology, which is usually used
for a two month work package, will provide skewed monthly data if the resources in the work
package are not loaded equally for each month. It will give an artificial positive or negative
schedule variance the first month and vice versa the next month.
Additional earned value methodologies, such as the weighted milestone methodology and percent
complete with milestone gates may be utilized. The weighted milestone method allows value tobe earned based on the resource value in each month, which eliminates artificial schedulevariances.
For all discrete measurable work packages or control accounts, there must be an activity in eachmonth to measure. Gaps, in which there is nothing to measure in a month or months is not
acceptable.
For subcontractors that have a fixed price contract with the prime contractor, the expectation isthat there will be no cost variance. The ACWP reported on the CPR will equal the BCWP earned,
regardless of the payment schedule with subcontractor.
Principle 6a: Analyze Significant Variances From the Plan
The purpose of this principle is to ensure that the earned value data is analyzed by the contractor
and reported to the customer. The 7 Principles programs should be able to calculate the costvariance (BCWP minus Actual Cost of Work Performed (ACWP) and the schedule variance(BCWP minus BCWS) at least on a cumulative basis. It is recommended that variances be8123

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calculated on a current month basis also. The EVM syste m should also provide both mo nthly andcumulative Cost Performance Index (BCWP divided by ACWP) and Schedule Performance
Index (BCWP divided by the BCWS). This data should be provided at the control account level
and at the roll up levels and it needs to be in a format for Control Account Managers and program
management to be able to utilize in managing the work.

It is also recommended that the To-Complete Performance Index (TCPI) be included in theControl Account Manager performance report. The TCPI is a valuable index that calculates thecost performance the control account needs to perform at in order to complete the work within thecurrent reported EAC. When the TCPI is compared against the cumulative CPI it gives a good
indication whether or not the current EAC is reasonable. For example, if a cumulative CPI is .85
and the TCPI calculates to equal 1. 15 that is the performance factor that work would need toperform at in order to meet the current EAC. If the cumulative CPI is .85 then it can be
determined that the current EAC might not be reasonable. It allows management and ProjectControls the opportunity to question the Control Account Manager as to the validity of thecurrent EAC. As a rule in thumb if the deviation between the CPI and the TCPI is greater than .2
then the CAM should reassess the control account EAC.
These reports, which should be provided monthly, should also include the current Budget atCompletion (BAC) and the current Estimate at Completion (EAC). In addition, it would be aplus if the CAM could see a report with their time-phased spread of hours and dollars for theirbudget plan (BCWS), work accomplished (BCWP) and actual costs (ACWP).
For all variances that exceed the contractual variance threshold will include a description of whatcaused the variance, impact to the control account and the program, and a corrective action.
Principle 6b: Prepare an Estimate at Completion Based on Performance to Date and Work
to be Performed
Providing an updated EAC is a prime concern of the customer and the contractor. Therefore arobust EAC process should be in place whether the program is ANSI compliant or not.
Based on the performance to date the Estimates at Completion can be updated on a monthly basisby the Control Account Manager in the scheduling tool during the status process or in the
cost/EVM tool at the end of the month's process prior to submittal of the EVM report. The EAC
is an element of the performance measurement system that needs to accurately reflect thecontractor's best estimate of what it will cost to complete the project.
Program management should be able to validate control account manager's EACs by looking at
performance indices, such as the To-Complete Performance Index, as well as independent
statistical EACs.
Principle 7: Use EVMS Information in the Company's Management Processes
One of the key areas that concerns government Program Management Offices (PMO) is the levelof importance that contractor's place on EVM as a management tool. During a site visit, such as
conducting an Integrated Baseline Review, the PMO gauges what the interest, knowledge, andmost importantly, the usage of the performance measurement data in managing the program.
They want to know that the managers on the program, including the program manager, have

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received some earned value training. The level of involvement and use of the EVM data to
manage their schedule, cost and technical issues is ascerta ined by questions. The PMO can also
tell by how robust the EACs are and if the variance narratives are being written with impacts tothe program and corrective actio ns being monitored by the contractor. It is important that thecontractor's management team, including the Program Manager, utilize the data from theperformance measurement system as a management tool. They should be knowledgeable andunderstand the data. They should know what is causing the variances and ensure that thevariance narratives are written properly and answer what the issues, impacts and corrective
actions are. They should be able to demonstrate that they use the information to assist them in the
management decision process. They should hold their Control Account Managers accountable touse the data and write clear proper variance analysis report (VAR). If the Control AccountManager does not write a proper VAR then Project Controls needs to help instruct them how to
do it. It is recommended that prior to the Earned Value report be sent to the government that theProgram Manager has a meeting with the Control Account Managers and Project Control andreview the data and ensure that the variance analysis is complete and that the Program Manager
agrees with it. This review is also used to ensure that the EACs are acceptable to the Program
Manager, who is ultimately responsible for the program EAC. This is an efficient and quick way
to make any adjustments to the earned value report since all the key personnel are in one room. If
the data appears to be unreliable then the PM needs to hold Project Controls accountable toensure that they are using discipline in changing baselines, assessing process properly, andcapturing actual costs to ensure that the data that is reported is accurate.

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APPENDICESThe follow ing appendices provide further support in understanding the meaning and intent ofproperly implementing the 7 Principles of EVM.
Appendix 1 is a glossary of the tenns used in the Intent Guide.
Appendix 2 is supplemental guidance on EVM implementation. It provides some guidelines o nwhat is expected in the implementation, required documents needed for the Performance
Measurement Baseline Review, expected EVM implementation costs, EVM engines functionality
needs, explains what is expected in the monthly EVM facilitation, discusses what EVM
consultants need to know, and what the expected costs of EVM to BARDA.
Appendix 3 are examples of some of the EVM documents that are needed in an EVM system.
There are three documents and they mostly apply to Tier 2 EVM implementations. These
documents are samples and are not a reflection of the specific way the document must look. It's
included to provide contractors with an understanding of the type of information that is expectedon these forms.

APPENDIX 1: Glossary of Terms
Actual Cost of Work
Performed (ACWP)T he costs actually applied and recorded in accomplishing
the work performed within a specified period.

Actual Direct CostThose costs identified specifically with a contract, based
upon the contractor's cost identification and accumulation
system as accepted by the cognizant DCAA representatives.
(See Direct Costs).

Advance Agreement (AA)An agreement between the contractor and the Contract
Administration Office concerning the application of an
approved earned value management system to contracts
within the affected fac ility.

Authorized Work

That effort which has been authorized and is on contract, orthat for which authorized contract costs have not been
agreed to but for which written authorization has been
received.

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Baseline(See Performance Measurement Baseline).

Budget at Completion (BAC)

The sum of all budgets (BCWS) allocated to the contract.
Synonymous with the term Performance Measurement
Baseline.

Budgeted Cost for Work
Performed (BCWP)The sum of the budgets for completed Work Packages andcompleted portions of open Work Packages, plus theappropriate portion of the budgets for level of effort andapportioned effort (Also see Earned Value).

Budgeted Cost for Work
Scheduled (BCWP)The sum of the budgets for completed Work Packages,planning packages, etc ., scheduled to be accomplished(including in-process Work Packages), plus the amount oflevel of effort and apportioned effort scheduled to beaccomplished within a given time period.

Change Order (CO)A formal authorization by the Procuring Contracting Officer
for a change of scope to an existing contract

Contract Modification

A written and binding authorization to proceed created after
change proposal negotiations.

Contract Budget Base (CBB)The negotiated contract cost plus the estimated cost of
authorized unpriced work, where:(1) Negotiated Contract Cost is that cost on which
contractual agreement has been reached. For an incentive
contract, it is the definitized contract target cost plus/minus
the value of changes which have been priced andincorporated into the contract through contract change orderor supplemental agreement. For fixed-fee contracts, it is thenegotiated estimated cost. Changes to the estimated cost
will consist only of the formal contract modifications orchange orders or change in the contract statement of work,
not for cost growth, and

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7 Principles of EVM Tier 2 System Implementatio n Intent Guide(2) Estimated cost of authorized, unpriced work is theestimated cost (excluding fee or profit) for that work forwhich written authorization has been received, but for which
definitized contract prices have not been incorporated into
the contract through supplemental agreement.

Control Account

A management control point at which actual costs can beaccumulated and compared to budgeted cost for work
performed. A control account is a natural control point for
cost/schedule planning and control since it represents thework assigned to one responsible organizational element on
one contract work breakdown structure (CWBS) element.

Control Account Manager(CAM)

A member of a functional organization responsible for task
performance detailed in a Control Account and for
managing the resources authorized to accomplish the tasks.

Control Account Plan (CAP)
ReportA CAP report is a timephased report which reflects all thework and effort to be performed in a control account. The
CAP report will reflect the hours and dollars by element ofcost (labor, subcontract, ODC, etc).

Contract Performance Report(CPR)

The monthly report submitted to the customer showing thecurrent, cumulative and at completion status, theperformance measurement baseline, manpower loading, anda narrative explanation of significant program variances.

Contract Target Cost

The dollar value (excluding fee or profit) negotiated in theoriginal contract plus the cumulative cost (excluding fee or
profit) applicable to all definitized changes to the contract.
It consists of the estimated cost negotiated for a cost plus
fixed fee contract and the definitized target cost for an
incentive contract. The contract target cost does not include
the value of authorized/un-negotiated work, and is thus
equal to the contract budget base only when all authorized
work has been negotiated/definitized.

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Cost Performance Index (CPI)An efficiency rating reflecting a project's budget
performance - either over or under. Measured as a ratio of
the budgeted value of work accomplished versus the actual
costs expended for a given project time period. The formulafor CPI is BCWP/ ACWP.

Discrete Effort

Program effort that has a measurable output, product orservice.

Direct Costs

Those costs (labor, material, etc.) that can be reasonably andconsistently related directly to service performed on a unitof work, and are charged directly to the contract, without
distribution to an overhead unit.

Earned Value

See Budgeted Cost for Work Performed (BCWP)

Earned Value Management
System (EVMS)

A project management system utilized for measuring projectprogress in an objective manner. Combines measurementsof scope, schedule, and cost in a single integrated system.

Estimate at Completion (EAC)

A value (expressed in dollars and/or hours) developed torepresent a realistic appraisal of the final cost of tasks whenaccomplished. It's the sum of direct & indirect costs to dateplus the estimate of costs for all authorized Work remaining.
The EAC = ACWP + the Estimate-to-Complete.

Estimate to Completion (ETC)

A value (expressed in dollar and/or hours) developed torepresent a realistic appraisal of the cost of the work stillrequired to be accomplished in completing a task.

Indirect Costs

Represents those costs, because they are incurred forcommon or joint objectives, are not readily subject to

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treatment as direct costs. (See overhead).

Integrated Baseline Review(IBR)

An Integrated Baseline Review (IBR) also known as
Performance Measurement Baseline Review (PMBR) is aformal review led by the Government Program Manager andTechnical Support Staff. An IBR is conducted jointly with
the Government and their Contractor counterparts.
The purpose of an JBR is to: verify the technical content of
the Performance Measurement Baseline (PMB); assess theaccuracy of the related resources (budgets) and schedules;
identify potential risks.

Integrated Master Plan (IMP)The overall program plan including the work definition,technical approach, performance criteria, and completion
criteria.

Integrated Master Schedule

The IMS expands the IMP to the work planning level. It
defines the tasks, their durations, milestones, milestone
dates which relate to the IMP completion criteria, andinterdependencies required to complete the program. The
IMP and IMS are used to track and execute the program.

(IMS)

Integrated Product Team(IPT)

A grouping of project personnel along project objectivelines rather than along organizational lines. Integrated
Product Teams are work teams that represent a transition
from a functional organization structure to a multifunctional project objective arrangement.

Internal Replanning

Replanning actions performed by the program for remaining
effort within the recognized total allocated budget.

Level of Effort (LOE)Work that does not result in a final product, e. g., liaison,
coordination, follow-up, or other support activities, andwhich cannot be effectively associated with a definable end
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product process result. It is measured only in terms ofresources actually consumed within a g iven time period.

Management Reserve (MR)An amount of the total Contract Budget Base (CBB)
withheld for management control purposes rather thandesignated for the accomplishment of a specific task or setof tasks. It is not a part of the Performance Measurement
Baseline.

Negotiated Contract Target
Cost

The esti mated cost negotiated in a Cost Plus Award Fee(CPAF), Cost Plus Fixed Fee (CPFF), Cost Plus Incentive
Fee (CPIF) or Fixed Price Incentive Fee (FPIF) contract.

Original Budget

The budget established at, or near, the time the contract was
signed, based on the negotiated contract cost.

Overhead

Indirect labor and material, supplies and services costs andother charges, which cannot be consistently identified withindividual programs.

Other Direct Costs

A group of accounting elements which can be isolated to
specific tasks, other than labor and material. Included in
ODC are such items as travel, computer time, and services

Performance Measurement
Baseline (PMB)

The time-phased budget plan against which contract
performance is measured. It is formed by the budgets
assigned to scheduled Control Accounts and the allocationof overhead costs. For future effort, not planned to theControl Account level, the performance measurement
baseline also includes budgets assigned to higher level WBS
elements, and undistributed budgets. It equals the total
assigned budget less management reserve.

Performing Organization

A defined unit within the program organization structure,
which applies the resources to performs the authorized scope
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Planning Package

A logical aggregation of far term work within a Control
Account that can be identified and budgeted but not yet
defined into Work Packages.

Reprogramming

Replanning of the effort remaining in the contract, resulting
in a new budget allocation which exceeds the contract
budget base. The resulting baseline is called an Over Target
Baseline (0TB).

Responsible Organization

A defined unit within program's organization structure thatis assigned responsibility for accomplishing specific tasks.

Risk Register

Is a tool commonly used in project planning andorganizational risk assessments. It is often referred to as a
Risk Log. It is used for identifying, analyzing andmanaging risks.

Schedule Performance Index(SPI)

An e fficien cy rating reflecting how quickly or slowly projectwork is progressing. Measured as a ratio of work
accomplished versus work planned for a given period oftime . The formula for SPI is BCWP/BCWS.

Significant VariancesThose differences between planned and actual cost andschedule performance which require further review,
analysis, or action. Appropriate thresholds are established as
to the magnitude of variances which will require varianceanalysis.

Statistical Estimate atCompletion

Is a single point estimate that can be quickly prepared andused to test the reasonableness of the cun-ent cost estimatesand budget and to indicate when a comprehensive EAC
should be prepared

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Time-Phased S/P/A Report

Provides the timphased budget, performance (earned value)
and actual costs at a specific level. It may be at thereporting level, control account, and/or work package level.
In all cases the report will also provide the data at the total
project level.

To-Complete Performance
Index (TCPI)

An efficiency rating that provides a projection of the
anticipated performance required to achieve the EAC. TCPI
indicates the future required cost efficiency needed toachieve a target EAC (Estimate At Complete). Any
significant difference between TCPI and the CPI needed tomeet the EAC should be accounted for by management intheir forecast of the final cost.

Total Allocated Budget (TAB)

The sum of all budgets allocated to the contract. Total
allocated budget consists of the performance measurement
baseline and all management reserve. The total allocatedbudget will reconcile directly to the Contract Budget Base
(CBB). Any differences will be documented as to quantity
and cause.

Undistributed Budget (UB)

Budget applicable to contract effort which has not yet been
identified to WBS elements at or below the lowest level ofreporting to the Government.

Variance Analysis Report(VAR)

The internal report completed by the Control AccountManager and submitted, through the Intermediate Manager,to the program manager for those Control Accounts whichhave variances in excess of established thresholds.

Variances(See Significant Variances).

Work Authorization Document(WAD)

A form used to formally authorize and budget work to theControl Account Manager. This document must include, asa minimum, the Control Account number, Statement ofWork, scheduled start and finish dates, budget, and the18133

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identity of the CAM. It must be approved by Intermediate
Manager, and be agreed to by the Control Account Manager.

Work Breakdown Structure(WBS)

A product-oriented, family-tree composed of hardware,
software, services, data and facilities which results fromsystem engineering efforts. A work breakdown structure
displays and defines the product(s) to be developed and/ or
produced and relates the elements of work to beaccomplished to each other and to the end product.

(1) Program WBS.

The work breakdown structure thatcovers the acquisition of a specific defense material item
and is related to contractual effort. A program work
breakdown structure includes all applicable elements
consisting of at least the first three levels of the work
breakdown structure and extended by the program manager
and /or contractor(s). A program work breakdown structure
has uniform element terminology, definition, and placementin the family tree structure.

(2) Contract WBS (CWBS) The complete WBS for acontract, developed and used by a contractor within theguidelines of MIL-Handbook 881 (latest revision) or NASAWBS Handbook (insert reference) or other customer
guidelines and according to the contract work statement. It
includes the approved work breakdown structure forreporting purposes and its discretionary extension to thelower levels by the contractor, in accordance with MILHandbook 881 and the contract work statement. It includes
all the elements for the products (hardware, software, data,or services) which are the responsibility of the contractor.
Work Packages

Detailed short-span jobs, or material items, identified by thecontractor for accomplishing work required to complete thecontract. A Work Package has the following characteristics.

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1. It represents units of work at levels where work is
performed.
2. It is clearly disting uishable from all other work
packages.
3.

It is assignable to a single organizational element.

4 . It has scheduled start and finish dates and, asapplicable, interim milestones, all of which are
representative of physical accomplishment.
5. It has a budget or assigned value expressed in termsof dollars, man-hours or other measurable units.
6. Its duration is limited to a relatively short span oftime or it is subdivided by discrete value milestones tofacilitate the obj ective measurement of work performed.
7. It is integrated with detailed
manufacturing, or other schedules.

Work Package Budgets

engineering,

Resources which are formally assigned by the CAM toaccomplish a Work Package, expressed in dollars and/or
hours.

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Appendix 2 Supplemental EVM Implementation Guideline
Implementation of a 7 Principles of EVM system should be less expensive than if there was an
ANSI/EIA-748. There is no need for the system to have to go through an EVM compliancereview, plus the level of documentation should be streamlined.
The implementation should include:•••

EVM Process flows that reflect how a company will build and maintain the EVM system.
(EVM Procedures may also be included if the cost associated with them is reasonable)
EVM engine tool and a schedule tool. It is not necessary to load the schedule tool, suchas Microsoft Project, with resources. This adds an extra strep, additional costs and little tono value. It is recommended that all resource information be loaded in the EVM engine
and leave the schedule tool to what it does best, measure progress through time
(duration).
The EVM Engine needs to be integrated with the company's accounting system.

Documentation needed for the Performance Measurement Baseline Review (PMBR)
•
•
•
•
•
•
•

WBS Dictionary/Control Account Work Authorization Documentation
Integrated Master Schedule
Responsibility Assignment Matrix
Control Account Plans
PMB Log
Baseline Revision Documents
Risk Register

EVM IMPLEMENTATION COSTS
The cost for an implementation depends on the size of the contract and the tier level of EVM.
Tier 2 (projects greater than $25M)
Implementation costs should range $75K-$150K
Tier 3 (projects less than $25M)
Implementation costs should range ($SOK - $100K)
EVM ENGINES/TOOLS
Depending on the size of the contract would predicate the level of functionality that would beneeded. For Tier 2 contracts a larger, more robust EVM engine would be needed. For the Tier 3
small contracts MS Project or the MSP wrap-around would probably suffice although the morerobust EVM engines can be used also.
Tier 2
It is recommended that one of the larger and flexible EVM engines be utilized. The tool shouldhave the flexibility to be able to download data from MS Project and be able to upload or input
budget data to provide time-phased budget information down to the work package level. It
should be able to incorporate the companies Organization Breakdown Structure. It should be able

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7 Principles of EVM Tier 2 System Implementation Intent Guide

to maintain baseline, actual costs, forecast and performance periodic data. It should be able toforecast Estimate to Complete w ith the abil ity to set up different rate tables if necessary. Itshould have the capability to use all earned value methodologies. It should be able to print many
types of EVM reports that can provide information to the Control Account Managers (CAM) and
Program Managers (PM), as well as, the Contract Performance Report (CPR) and the Control
Account Plans (CAP) that are contract deliverables.

Tier 3
For Tier 3 projects, a company can certainly utilize an EVM engine as listed above or a lessrobust, less expensive EVM engine that provides the CPR and timephased S/P/A report. It may
also use the Microsoft Project wrap-around tools of which there are several on the market. These
tools also will provide the CPR and timephased S/P/A report for contract deliverable purposes.

EVM FACILITATION
EVM facil itation pertains to the monthly process to include:• Schedule Status• Integration of accounting data into EVM engine• Run monthly reports for Control Account Managers (Tier 2 only)• Prepare the monthly Contract Performance Report (CPR) Formats 1 and 5• Run the Control Account Plans for both internal and external (contract
requirement)• PMB Change Control
Depending on the size of contract, a contractor should have an EVM/cost analyst and scheduleanalyst for a Tier 2 contract and one combined cost/schedule analyst for a T ier 3 contract. The
costs for a schedule analyst o n a yearly basis for an employee hire should be equal to or less than
$135K. For a cost analyst it should be equal to or less than $120K. If a company is bringing in acontractor to provide staff implementation the costs should be up to $135/hr for a scheduleanalyst and $120/hr for an EVM/cost analyst.

EVM CONSULTANTS
There may be the need to bring in consultants to help set up your EVM system and perhaps
provide EVM staff augmentation to provide the monthly facilitation. Make sure that you shop
around and get several quotes. Also make sure that the consultants understand the statement ofwork pertaining to the BARDA EVM requirements. Most EVM consultants are used to working
with companies that have a requirement to implement an ANSl/748 compliant EVM system per
the DoD requirements and it is important that they have an understanding of what is required in a
7 Principles EVM implementation so that they don't propose much more complex EVM systemthan is needed. Please be advised that the government will only accept reasonable costs
associated with implementing a 7 Principles of EVM system.

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7 Principles of EVM Tier 2 System Implementation Intent Guide

COSTOFEVM

BARDA is working diligently to keep the costs of EVM implementation and facilitation at areasonable level. Since the goal at BARDA is to provide an integrated, systematic approachto the developme nt and purchase of the necessary vaccines, drugs, therapies, anddiagnostic tools for public health medical emergencies, it is imperative that the funds for
product development are used for that such purpose. BARDA expects the costs for
implementation and monthly facilitation ofEVM to range 1%-2% of development budget. Thisis ratified by the white paper by Dr. Christenson titled ''The Costs and Benefits of the Earned
Value Management Process".

23
138

7 Principles of EVM Tier 2 System Implementation Intent Guide

Appendix 3 Sample EVM Documents

WBS 1.4.1.x Cardiac (QTc) Safety

Description

Study Title: "A Phase 1 study to assess the cardiovascular safety of intravenous (IV)
Panaceomycin in volunteers" (Thorough QT Study)

We will conduct a thorough evaluation of the cardiac effect of Panaceomycin Injection via arandomized, double-blind crossover study. A total of 100 participants (18-22 per arm) will
randomize to one of five study arms to receive in a double-blind fashion a single IV infusion ofeither Panaceomycin Injection 10 mg/kg, Panaceomycin Injection at a supra-therapeutic dose,
ciprofloxacin (positive control), or placebo. 12-Lead digital ECGs will be collected in triplicate
via Holter monitor from each participant during dosing. Seven days after dosing, participants will
be re-randomized to receive another treatment. ECGs will be collected and analyzed. A fullstatistical analysis and expert ECG report will be generated. Serum PK samples will also becollected at ECG collection time points and analyzed to confirm exposure.

Targeted Outcome: No evidence of delay in cardiac repolarization induced by Panaceomycin asshown by analysis of the QT interval.

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7 Principles of EVM Tier 2 System Implementation Intent Guide

Subcontractors
VendorPhase Research

Area of Responsibility
Study Documentation Design and Development
Clinical Monitoring: Includes site initiation, interim, and close-out
monitoring visits,
Pharmacovigilence
Data Management: Includes build and maintenance of electronic casereport forms (eCRFs); data query generation and resolution
Biostatistics
Medical Writing:
Project Management: The Project Manager will actively facilitate
Phase Research' s interaction with the research site and provide closemonitoring oversight in conjunction with the assigned CRA. ProjectManagement will also assist in the finalization of all applicable study
documents and provide coordination between study vendors.
Pass-through Expenses

0
0
0
0
0
0
0

0

Travel for CRA monitoring visits to clinical sites, shipping andprinting costs
Investigator Grants

0

Energetics

Core Cardiac Lab

TBD

Clinical study site(s)Pulse Tech

To provide Central Lab services

AnalyxTo perform PK analyses

Claritron

To write the PK report

Obelisk

To label and distribute study drug productConsultants
Joe Josephs

Internal Medical Monitor:
Sponsor medical oversight

RolfXerd

Pharmacologist:
Design and analysis consultation for PK parameters and analysis

Julie Simms

Clinical Trials Manager

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7 Princ iples of EVM Tier 2 System Implementatio n Intent Guide

Phil Thomas

Medical Writer

Claire Cools

SAS Programmer

Mary Doe

Clinical Contracts

Jim Dodds

Supply Chain M anager

Milestones, EV at Milestones
Consultants and Phase Project Management will earn value as Level of Effort activities.
All other costs will earn value according to the schedule below.
Signed Study Protocol
First participant dosed
40 % Enrollment
70% Enrollment
Last participant procedure (Treatment phase)
Last participant fo llow-up
Database lock
Clinical Study Report
Transferred Trial Master File

10 %
20 %
35%
50%
60 %
70 %
80 %
90 %
100 %

Deliverables
1. Signed Study Protocol
2. Top-line data
3. Signed Clinical Study Report

External Dependencies
1. Top-line Data from an External Clinical Study Identifying Panaceomycin

Maximum Tolerated Dose as a single dose in Humans. The Maximum Tolerable
Dose will be defined in a study not included in the BARDA contract. This dose
will be used in selecting the Supra-therapeutic dose in this Thorough QT Study.
2. Successful production of cGMP lot of Panaceomycin.
3. Enrollment and retention of study participants.

Sample WBS Dictionary

26
141

7 Principles of EVM Tier 2 System Implementation Intent G uide~-ork Authorization
Proje,c_t/C.ontnc,tR\.RDA

Octl0 I0

xhNiul+dS1.a rt

Authorizationn.reian'f\YBS 'I'

I. l.6.1

xheduled fumhs~p 1012

Work Description
staff v.ill man"g~ the int;,gr,J.tion .and p arforman« control of th;, pro gr~.

for furth~ detail, s« description of scope for V,BS l.1.6.l

Budget
S 2~0,000

Labor

s

Subc,o nl:raCll o r:sCon..eul1ants

To1aJ

S 250,000

Approvals
Cu trol Aru11mt Yauger

Si:gutan:Date:

PnojfCt Yll.ll~USi~uture:

Date:

Fin.Ince

Sig11.1turt:

Datt:

Sample Work Authorization Document27142

7 Principles of EVM T ier 2 System Implementation Intent Guide

I

CAP:

1.J.J Dr'II,/ Prmtion

Moot!I End:

3/31/1011

CJ

Control Account Performance

8(WS
8CWP
ACWP

sv
CV

Month 1 Month 2 Month3 Month 4 Month 5 Month 6 Month 7 Month 8 Month 9 Month 10 Month II Month 12

To1al

80

2.1

675

Monih 1 Month 2 Month 3 Montll 4 Month 5 Month6 Montll 7 Month g Month 9 Month 10 Montl111 Month 12

To1al

200
10
12
-190
·1

30
190
190
160
0

30
60
60
30
0

40

60

60

80

15

25

lO

,Resource Summaf'/labor
Sub DBSub OP
Sub Pack
Matenal

190

DOC
B(WS

200

10

10
10

30

10
20

30

10
30

40

10

10

10

10

50

70

50

70

60

80

60

80

10

5
15

10

10

10

5

10

15

10
25

lO

25

-

120
70
240
40
190
15
675

Wort Package Summaf'/
EVM
Sub Contract Management LOE
Purchase Materials
0/100
ManufactureDrug Susbstanc MS
Manufacture DrugProduct MS
Ship
UnilS
Package &Store
Units

B(WS

Month 1 Month 1 Month 3 Montll 4 Month 5 Montll 6 Montll 7 Montll 8 Month9 Month 10 Montll 11 Month 11
10
10
10
10
10
10
10
10
10
10
10
10
190
10
20
30
50
70
50
70
5
10
5
20
15
100
lO
30
40
60
80
60
80
15
25
JO
25

Sample Control Account Plan

28

143

Total
120
190
70
240
15
40

-

675