PART I – THE SCHEDULESECTION B – SUPPLIES OR SERVICES AND PRICES/COSTSARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES
There are currently no medical countermeasures available for the prophylaxis ortreatment of infection with Ebola virus, a high priority agent for the Public Health
Emergency Medical Countermeasures Enterprise (PHEMCE) Implementation Plan.
The objective of this contract is to advance the development of V920, a vaccine
against Ebola virus using a recombinant Vesicular Stomatitis Virus vector. The
scope of work for this contract includes non-clinical, clinical, regulatory, andmanufacturing development activities that fall into the following areas: non-clinical
toxicology studies; clinical activities; manufacturing activities; and all associatedregulatory, quality assurance, program management, and administrative activities.
The Research and Development (R&D) effort for V920 will progress in specificstages that cover one base performance segments and three (3) option segments as
specified in this contract. The Contractor must complete specific tasks required ineach of the four (4) discrete work segments. The scope of work has been broken
into the following base period and three options which are discrete work segments:
Base Period: Facility, Site, Process Performance Qualification (PPQ) Readiness
Activities
Option 1: Manufacturing and Testing of PPQ Lots, BLA Preparation, and Pre-PAI
Activities
Option 2: Pediatric Clinical Trial
Option 3: Additional Process Simulations and Manufacturing of PPQ LotsWork performed during the base segments and during each option segment
constitutes an independent, non-severable discrete work segment that cannot be
subdivided for separate performance and is necessary to support R&D tasks related
to the platform. Each non-severable, work segment constitutes an entire job(discrete requirement) which shall contain multiple R&D activities that whenreviewed in total shall satisfy a defined end-product. There are technical andprogrammatic deliverables and milestones within a work segment that may trigger
the execution of option(s). The non-severable work segment will be fully fundedfrom an appropriation source that will be current at the time the work is authorized
to begin. See the Statement of Work, Attachment #1.
The Government has determined a Bona Fide Need for each non-severable discrete
work segment which will conclude upon the completion of a defined task(s) thatprovides independent merit and value to the Government. The Contractor mustachieve defined deliverables and/or milestone(s), as outlined in the SOW of thiscontract, before the Government will consider exercising any of the follow-on
option segment(s). 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 of this contract. Those deliverables will support the
GO/NO GO Contract Milestones and Decision Gates specified therein. The
GO/NO GO Contract Milestones and Decision Gates will constitute the basis for theGovernment’s decision, at its sole discretion, to exercise any follow-on option
segment(s).
The base and option segments under Contract Line Items (CLINs) 0001 through0004 are event driven work segments rather than time driven CLINs. The funds foreach independent, non-severable discrete work segment (requirement), regardless ofduration, are separated by CLIN, and shall only be used for the scope of work
covered in each discrete work segment. The periods of performance listed undereach of the CLINs under Article B.2 and Article B.3 below are estimated time
periods. Those individual time periods may be extended by mutual agreement of
the parties to complete the tasks required under each work segment. It is possiblethat 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 concurrently.
ARTICLE B.2. ESTIMATED COST
1. The total estimated cost of this contract is(b) (4).
2. CLIN 0001, is the base performance segments, and CLINs 0002 through 0004
are the option periods, with all being cost-reimbursement CLINs.
3. The Government shall provide monies for the base performance segment(CLIN 0001) in an amount not to exceed $24,752,733. The total amountobligated by the Government for the base segment of the contract shall not
exceed the Total Estimated Cost of $24,752,733. and the Government will not
be responsible for any Contractor incurred costs that exceed this amountunless a modification to the contract is signed by the Contracting officer
which expressly increases this amount.
4. The Contractor shall maintain records of all contract costs and such records
shall be subject to the Audit and Records-Negotiation and Final Decisions on
Audit Findings clauses of the General Clauses.
5. Costs contributed by the Contractor shall not be charged to the Government
under any other contract, grant, or cooperative agreement (including allocation
to other grants, contracts, or cooperative agreements as part of an independent
research and development program).
6. Consistent with FAR 52.216-8, Fixed-Fee (Jun 2011), any fixed fees payablein the base or 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 Article B.2. and B.3 for each option
period, and the Contracting Officer may withhold a portion of the total fixed
fee for each option period in an amount not to exceed 15 percent of the fixed
fee or $100,000, whichever is less, consistent with FAR 52.216-8, Fixed Fee(Jun 2011).
7. It is estimated that the amount currently allotted will cover performance of thecontract through 31 May 2020 for the base period.
BASE PERIOD

CLIN

Estimated
Period of
Performance0001

9/1/2016
Through
5/31/2020

Supplies/Services
Facility, Site, Process
Performance
Qualification (PPQ)
Readiness Activities

TOTAL

Estimated USG
Cost

Fee/profit

Total
EstimatedCost(b) (4)(b) (4)$24,752,733(b) (4)(b) (4)$24,752,733

ARTICLE B. 3. OPTION PRICES
a. Unless the government exercises its option pursuant to the option clausecontained in ARTICLE I.2, the contract consists only 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 information regarding
the time frame for this notice is set forth in the OPTION CLAUSE Article in
SECTION G of this contract. The amount obligated to the contract will be
increased as set forth below:
OPTIONS
Option 1 (CLIN 0002) thru Option 3 (CLIN 0004)
CLIN

OptionPeriodEstimated
Period ofSupplies/Services

Fee/Profit
Estimated

Total
EstimatedPerformance(b) (4)

0002

0001

0003

0002

(b) (4)(b) (4)

0004

0003

USG Cost
Manufacturing
and Testing of
PPQ Lots, BLA
Preparation, and
Pre-PAI
Activities
Pediatric Clinical
Trial
Additional
Process
Simulations andManufacturing of
PPQ Lots(b) (4)(b) (4)(b) (4)ARTICLE B. 4. LIMITATIONS APPLICABLE TO DIRECT COSTS
a. Items Unallowable Unless Otherwise Provided
Notwithstanding other clauses and unless authorized in writing by the Contracting
Officer, the cost of the following items or activities shall be unallowable as direct
costs:
1) Acquisition, by purchase or lease, of any interest in real property;2) Special rearrangement or alteration of facilities;3) Accountable Government Property (see the HHS Contracting Guide forControl for Government Property incorporated by ARTICLE G.10. of thiscontract);
Note: this includes the lease or purchase of any item of general purpose officefurniture or office equipment regardless of dollar value.
4) Purchase or lease scientific instruments or equipment over $1,500;
5) Travel to attend general scientific meetings/conferences;
6) Printing Costs (as defined in the Government Printing and Binding
Regulations);
7) Overtime (premium) compensation

Cost8) Entering into certain types subcontract of arrangements (See Article B.5(c) for
specific obligations). Note that most consulting agreements require CO’s
written consent.
9) Foreign Travel (see Subparagraph b.3);
10) Patient care costs (see Attachment 6);11) Light Refreshment and Meal 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 information: (a) name,date, and location of the event at which the light refreshments and/or meals 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 receiving light refreshments and/or meals; and(e) confirmation of whether if the event will be held at a government facility.
b. Travel Costs
1. Total expenditures for travel (transportation, lodging, subsistence, and incidental
expenses) incurred in direct performance of this contract during the base segment(CLIN 0001) shall not exceed (b) (4) without the prior written approval of theContracting Officer. The Contractor shall notify the Contracting Officer inwriting when travel expenditures have exceeded (b) (4)) of the basesegment travel expenses. Cost must be consistent with Federal Acquisition
Regulations (FAR) 52.247-63 – Preference for U.S. Air Flag carriers. Costs
incurred for lodging, meals, and incidental 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. above, theContactor shall invoice and be reimbursed for all travel costs in accordance with
Federal Acquisition Regulation (FAR) 31.2 – Contracts with Commercial
Organizations, Subsection 31.205-46, Travel Costs.
3. If foreign travel is necessary, a Contracting Officer Authorization (COA) will be
required. Expenditures for foreign travel (transportation, lodging, subsistence, andincidental expenses) incurred in direct performance of this contract shall 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 personnel 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 one (1) 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
during normal business hours , who shall be subject to the Contractor’s policies
and procedures regarding security, facility access, and training at all times whilein the Contractor’s facility. As determined by federal law, no Government
representative shall publish, divulge, disclose, or make known in any manner, orto any extent not authorized by law, any information coming to him in the courseof employment or official duties, while stationed in a contractor plant.

b.

Security
A Security Plan is required for this effort. A security waiver may be requested. In
the event a security waiver cannot successfully be attained, the Government will
notify the Contractor who will subsequently will be required to deliver a security
plan to the Government, conforming with the following paragraphs.
The work to be performed under this contract will involve access to sensitive
Biomedical Advanced Research and Development Authority [BARDA] program
information. Upon contract award, the Program Protection Officer (PPO) will
request submission of a Draft Security Plan for Merck’s (b) (4)) withinninety (90) days of contract award and review the Draft Security Plan in detailand submit comments within ten (10) business days to the CO to be forwarded to
the Contractor. The Contractor shall review the Draft Security Plan comments,
and if changes are required, submit a Final Security Plan to the U.S. Government
within thirty (30) calendar days after receipt of the Program Protection Officer’s(PPO) comments.
The Final Security Plan shall include a timeline for compliance of all the required
security measures. Upon completion of initiating all security measures, theContractor shall supply to the CO and Contracting Officer’s Representative(COR) a letter certifying compliance to the elements outlined in the Final Security
Plan. The execution of the work under this contract shall be in accordance withthe approved Final Security Plan. As outlined above, the content of the Final
Security Plan shall be considered as part of the Contractor’s Technical Proposal.
The Contractor shall ensure that the storage, generation, transmission or
exchanging of BARDA sensitive information has the appropriate security controls
in place. At a minimum, the Final Security Plan shall address the following items:
Personnel Security Policies and Procedures including, but not limited to:
Recruitment of new employees; Interview process; Personnel background checks;
Suitability/adjudication policy; Access determination; Rules of behavior/conduct;
Termination procedures; Non-disclosure agreements.
Physical Security Policies and Procedures including but not limited to:Internal/external access control; Identification/badge requirements; Facility visitor
access; Parking areas and access; Barriers/perimeter fencing; Shipping, receiving
and transport (on and offsite); Security lighting; Restricted areas; Signage;Intrusion detection systems; Closed circuit television; Other control measures.
Information Security Policies and Procedures including but not limited to:
Identification of sensitive information; Access control/determination; Secured
storage infrastructure; Document control; Retention/destruction requirements.
Information Technology Security Policies and Procedures including but notlimited to: Intrusion detection and prevention systems; firewalls, Encryption
systems; Identification of sensitive information/media; Passwords; Removable
media; Laptop policy; Media access control/determination; Secure storage;
System document control; System backup; System disaster recovery.
Security Reporting Requirement - Violations of established security protocols
shall be reported to the CO and COR within 24 hours of the contractor’s
discovery of any compromise, intrusion, loss or interference of its security
processes and procedures. The Contractor shall ensure that all software
components that are not required for the operation and maintenance of thedatabase/control system have been removed and/or disabled. The Contractor shallprovide to the CO and the COR information appropriate to Information andInformation Technology software and service updates and/or workarounds tomitigate all vulnerabilities associated with the data and shall maintain the required
level of system security.
The Contractor will investigate violations to determine the cause, extent, loss orcompromise of sensitive program information, and corrective actions taken toprevent future violations. The CO in coordination with BARDA will determine
the severity of the violation. Any contractual actions resulting from the violation
will be determined by the Contracting Officer.
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.
d.

Confidential Treatment of Sensitive Information
The Contractor shall guarantee strict confidentiality of any information/data of asensitive nature that is provided to the Contractor by the Government during theperformance of the contract. The Government has determined that the
information/data that the Contractor will be provided during the performance ofthe contract is of a sensitive nature.
Disclosure of information/data that is sensitive in nature, in whole or in part, by
the Contractor can only be made after the Contractor receives prior written
approval from the Contracting Officer. 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 information/data shall not be deemed of asensitive nature with respect to the Contractor for purposes of this contract if suchinformation/data: (a) was already known to the Contractor at or prior to the timeof its disclosure to the Contractor; (b) was generally available or known, or wasotherwise part of the 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 information/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 party 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 the useof information/data belonging to the Government.
Contractor may disclose information/data of a sensitive nature provided by theGovernment to the extent that such disclosure is: (a) made in response to a valid
order of a court of competent jurisdiction or other supra-national, federal,national, regional, 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
information/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 further that if a disclosure order is
not quashed or a protective order is not obtained, the information/data disclosed in
response to such court or governmental order shall be limited to that information
which is legally required to be disclosed in response to such court or
governmental order; (b) otherwise required by law, in the opinion of legal counsel
to the Contractor as expressed in an opinion letter 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 regulatory 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 effort to build a robust medical countermeasure pipeline through increased
collaboration, BARDA may share technical deliverables set forth in Article F.2
with Government entities responsible for Medical Countermeasure Development
to the extent permitted by and with restrictions required under FAR 52.227-14,
Alternate II. This provision applies to all deliverables and data developed duringperformance This advance understanding does not authorize BARDA to sharefinancial information outside HHS. The Contractor is advised to review the termsof FAR Clause 52.227-14 regarding the Government’s rights to deliverables
submitted during performance as well as the Government’s rights to datacontained within those deliverables.

f.

Overtime Compensation
No overtime (premium) compensation is authorized under the subject contract.

g. (b) (4)h. Disclosure by Contractor
Notwithstanding any other provision in this contract, Contractor may disclose any
information relating to this Agreement to its affiliates, subcontractors, or third
parties that have an interest in V920, subject to any restrictions on further use or
disclosure that may apply to Contractor under this contract. If authorized byContractor, recipients of information under this provision will have the samerights as Contractor to use, release to others, reproduce, distribute, or publish suchinformation.
i. All cost for insurance must be reviewed and approved by the CO in advanceand cannot exceed authorized funding amounts.

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 and is not binding. . The total amount of this contractreflects the use of the 7 Principles of EVMS Implementation. Any EVMS
implementation requirements that are beyond the intent of the 7 Principles of EVMS
Implementation shall not proceed until the Contracting Officer sends a written request
for a proposal to the Contractor and a bilateral modification is issued to the contract
for the purposes of incorporating the additional costs for the performance of theserequirements into the contract.
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 during 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.
b.

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/AMCG in Washington, D.C. or at work sites of theContractor 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.
c.

Face-to-Face Project Review Meetings

The Contractor shall, at a time to be determined 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/subpart352.html.
FAR Clause
52.242-15
52.246-8

Title and Date
Stop Work Order (Aug 1989)
Inspection of Research and Development - CostReimbursement (May 2001)

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 performance. The COR however is not
authorized to change any contract terms or authorize any changes in the Statement ofWork 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 Acquisitions Management, Contracts, and Grants (AMCG) Office of theAssistant Secretary for Preparedness and Response
U.S. Department of Health and Human Services 330 Independence Avenue, S.W.,
Room G644 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 5 business days’ 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. Such site visits andinspections shall be limited to facilities or parts of facilities directly related to theperformance of this contract and 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 cost requirements in FAR Subpart 31.2.
The Contractor shall coordinate these visits and shall have 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 the Contractor. 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 interested party identifies any issues during an audit,
the Contractor 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 theContractor within ten (10) 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. ESTIMATED PERIOD OF PERFORMANCEThe estimated period of performance for this contract shall be consistent with the dates
set forth in the base period CLIN 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 Article B.3.
ARTICLE F.2. DELIVERABLES
Successful performance of the final contract shall be deemed to occur upon completionof performance of the work set forth in Attachment 1, the Statement of Work dated 12
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.
All deliverables and reporting documents listed within this section shall be delivered
electronically (as defined in SECTION F.3. ELECTRONIC SUBMISSION) to the CO,CS, and the COR unless otherwise specified by the Contracting Officer.
Summary of Contract Deliverables
Unless otherwise 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 documents/reports submitted under this contract shall 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 USG under the resultant Contract (including invoices) shallbe addressed as follows:
HHS/ASPR/AMCG
ATTN: (b) (6), Contracting Officer (CO)330 Independence Avenue, S.W., Room G640 Washington, DC 20201
Email : (b) (6)
HHS/ASPR/BARDA
ATTN: (b) (6),Contracting Officer’s Representative (COR)
330 Independence Avenue, S.W.,
Washington, DC 20201
Email: (b) (6)1. 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 forth in SECTION D.

i.

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:
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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 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. thathave taken place during the reporting period. Include progress on
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 are

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planned; 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 Master 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 theAnnual Progress Report is submitted.
ii.

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 therequirements 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 III: 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.
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 52.227-11.
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
performed related to WBS and Gantt chart, the results obtained,
and the impact of the results on the scientific and/or public healthcommunity including a listing of all manuscripts (published andin preparation) and abstracts presented during the entire period of
performance 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.
iv. Summary of Salient Results
The Contractor shall submit, with the Final Report, a summary (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.

vi. Other Technical Reports
1. Draft Report for Clinical and Non-Clinical Studies and Final Report
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”
 Draft Final Report for Clinical and Non-Clinical Studies funded bythis contract will be submitted to the Contracting Officer’s
Representative and Contracting Officer (CO) for review and

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comment within the time frames set forth in the table (“Summaryof Contract Deliverables”) 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 reports
to address BARDA’s recommendations prior to FDA submission.
The Government shall provide written comments to the Draft Final
Report for Clinical and Non-Clinical Studies in accordance withthe dates set forth by the table in this Article.
The comprehensive Final Report 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 thefollowing contract funded documents as specified below but notlimited to: Process Development Reports; Assay Qualification
Plan/Report, Assay Validation Plan/Report, Assay Technology
Transfer Report, Batch Records, Contractor/Subcontractor
Standard Operating Procedures (SOP’s), Master Production
Records, Certificate of Analysis, Clinical Studies Data or Reports.
The COR and CO reserve the right to request within the period of
performance an unredacted technical document for distribution
within the USG. Contractor shall provide technical document
within 10 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

i. FDA Meetings
The Contractor shall forward the dates and times of any meeting with the
FDA to COR and make arrangements for appropriate Government staff toattend the FDA meetings. The Government staff shall include up to a
maximum of four people (COR, CO and up to 2 subject matter experts).
 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 5

business days of receipt. All documents shall be duly marked as either“Draft” or “Final.”
ii. 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 the Contractor within 5 business days after receipt, provided
that COR reserves the right to request more than 5 business days forreview of any regulatory submission that is of significant length. The
Contractor shall inform COR of the anticipated submission length so
COR can make a determination on required time for review..
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 3 calendar days 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.

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.
Within 10 business days of audit report, Contractor shall provide COwith a plan for addressing areas of nonconformance, if any are
identified.

iv. 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.

v. Other FDA Correspondence
The Contractor shall memorialize any correspondence between Contractor and
FDA and submit to BARDA. All documents shall be duly marked as either“Draft” or “Final.” Contractor shall provide written summary of any FDA
correspondence within 5 business days of correspondence.
C.

Earned Value Management (EVM) Deliverablesi.

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 of

work 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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ii.

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)
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 90 days after start of base period andeach exercised option period.

Integrated Master Plan (IMP)The Contractor shall provide an IMP including WBS, critical path
milestones, and Earned Value Management Plan
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iii.

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
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.

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iv.

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 businessdays 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SECTION G - CONTRACT ADMINISTRATION DATAARTICLE G.1. CONTRACTING OFFICER
The following Contracting Officers (CO) will represent the USG for the purpose of thiscontract:(b) (6)

Contracting Officer
DHHS/OS/ASPR/AMCG
330 Independence Avenue, S.W. Room G640 Washington, D.C. 20201(b) (6)(b) (6)(b) (6)

Contract Specialist
HHS/ASPR/AMCG
330 Independence Ave., S.W., Room G640
Washington, DC 20201(b) (6)(b) (6)

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 contract. 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 incurred during the performance of this contract; (5)otherwise change any terms and conditions of this contract.
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 contract:
ATTN: (b) (6), PhD

Contracting Officer’s Representative (COR)
Biomedical 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.
Room G644
Washington, D.C. 20201(work)(b) (6)(b) (6)

Alternate COR:
ATTN: (b) (6),Contracting Officer’s Representative (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.
Room G644
Washington, D.C. 20201(b) (6)

Email: (b) (6)The COR is responsible for:1) Monitoring the Contractor's technical progress, including the surveillance andassessment of performance and recommending to the Contracting Officer changes inrequirements;
2) Assisting the Contracting 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 this 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 individuals are considered to be essential to the work being performed
hereunder:
#
1

Name

Function(b) (4), (b) (6)(b) (4), (b) (6)234(b) (4), (b) (6)(b) (4),The key personnel specified in this contract are considered to be essential to work
performance. At least thirty (30) business days prior to diverting any of the specified
individuals to other programs or contracts, including, where practicable, an instance when
an individual must be replaced as a result of leaving the employ of the Contractor, theContractor shall notify the Contracting Officer and shall submit comprehensive
justification 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 attached 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 shall be reported within the
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 report submitted.

c.

The first financial report shall cover the period consisting of the first full 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 Individual
Project/Contract” to reflect the allotment of additional funds.

ARTICLE G.5. 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 reports
furnished to the Government under the resultant contract (including invoices) shall be
addressed as follows:(b) (6)(b) (6)(b) (6)

Contracting Officer
HHS/ASPR/AMCG
330 Independence Ave.,
S.W., Room G640
Washington, DC 20201
Email:

Contract Specialist
HHS/ASPR/AMCG
330 Independence Ave.,
S.W., Room G640
Washington, DC 20201
Email:(b) (6)(b) (6)

Contracting Officer
Representative
HHS/ASPR/AMCG
330 Independence
PSC Invoices
Ave., S.W.,@psc.hhs.gov
Washington, DC
20201
Email:(b) (6)a.

Contractor invoices/financial reports shall conform to the form, format, 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 the 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 theestimated 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 clause—(1) The Government is not obligated to reimburse the Contractor for costs

incurred in excess of (i) the estimated cost specified in the Schedule or, (ii) if thisis a cost-sharing contract, the estimated cost to the Government specified in the
Schedule; and(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 theContracting Officer (i) notifies the Contractor in writing that the estimated costhas 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 inaccordance with the formula specified 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 incurred afterward,
unless the Contracting Officer issues a termination or other notice directing thatthe increase is solely to cover termination or other specified expenses.
(g) Changeorders 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 amountis over$1,500.

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 COA
i. Other Direct Costs - Include detailed breakdown when total amount isover$1,500.
j. G&A - Cite rate and amount.
k. Total Costl. Feem. Total Cost Plus Fixed Feee.

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
31 clauses’ 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 Firm Fixed Price Contracts to the maximum extent practicable.
Additional instructions and an invoice template are provided in Attachment 2,
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 withgovernment regulations. Invoices should be submitted electronically (in accordance withARTICLE F.3., (ELECTRONIC SUBMISSION) Only with signature.
If applicable, the Contractor shall convert any foreign currency amount(s) in the monthly
invoice to U.S. dollars each month, on the 1st 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 CLIN(s) in Section B under the contract.

ARTICLE G.6. REIMBURSEMENT OF COST
1) The Government shall reimburse the Contractor the cost determined by theContracting Officer to be allowable (hereinafter referred to as allowable cost) inaccordance with FAR Clause 52.216-7, 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 following:a) All direct materials and supplies that are used in performing the work provided forunder the contract, including those purchased for subcontracts and purchaseorders.
b) All direct labor, including 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 diem 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 direct route using coach-class which
may also be referred to by airlines as “tourist class,” “economy
class,” or as “single class” when the airline offers only one class ofaccommodations to all travelers. Government and contractor
travelers are required to exercise the same care in incurring
expenses that a prudent person would exercise if traveling on
personal business when making official travel arrangements, andtherefore, should consider the least expensive 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/graphics/ogp/FTR2011-02Complete.pdf)(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 (FTR).

(iv)

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

ARTICLE G.7. INDIRECT COST RATE
The following contractor established provisional billing rates are incorporated into thecontract, and will be utilized for billing purposes 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.
Rate Type

Rate

Allocation Base(b) (4)Use of the above provisional rates does not change any cost ceilings, contract obligations,or specific allowance or disallowance provided 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 indirect expenses to BioProtection Systems.
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 be
submitted to the cognizant agency’s Contracting Officer within 6 months subsequent toeach of the contractor’s fiscal year ends. (See also FAR Clause 52.216-7(d) (2)incorporated herein). Copies of the indirect cost submission for each fiscal year must also
be submitted to the AMCG contracting officer, and the AMCG auditor identified.

ARTICLE G.8. POST AWARD EVALUATION OF CONTRACTORPERFORMANCE

1. Contractor Performance Evaluations
Interim and final evaluations of Contractor performance will 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 permitted fourteen calendar
days to review the document and to submit additional information or a rebutting
statement. If agreement cannot be reached between the parties, the matter will bereferred to an individual one level above the Contracting Officer whose decision 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 Performance 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/cparsmain.htm
The registration process requires 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
within the required 14-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 1 of the contract.
ARTICLE G.10. GOVERNMENT PROPERTY
a. In addition to the requirements of the FAR Clause 52.245-1, GOVERNMENTPROPERTY, incorporated in SECTION I of the contract, the Contractor shall comply
with the provisions of HHS Publication, “HHS Contracting Guide for Contract ofGovernment Property,” which is incorporated into the contract by reference. This
document can be accessed at: http://ncioa.cancer.gov/oainternet/reference/Appendix_Q_HHS_Contracting_Guide-508.pdf
Among other issues, this publication provides a summary of the Contractor’s
responsibilities regarding purchasing authorizations and inventory and reporting
requirements under the contract.
b. Notwithstanding the provisions outlined in the HHS Publication, “HHS

Contracting Guide for Contract of Government Property,” which is incorporated
in the contract in paragraph a. above, the Contractor shall use the form entitled,“Report of Government Owned, Contractor Held Property” for submitting
summary reports required under this contract, as directed by the Contracting
Officer or his/her designee.
c. Title will vest in the USG for equipment purchased as a direct cost.
ARTICLE G.11. EXERCISE OF OPTIONSUnless the Government exercises its option pursuant to the Option Clause set forth in
Section I, Article I.2, the contract will consist only of CLIN 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 I.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 may then be increased as set forth in Section B,
Article B.3 provided that Government funds are available.
SECTION H - 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 shall be
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 begin. 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 submission. The Contractor must provide COR with acopy of FDA submissions, within the time frame set forth by ARTICLE F.2 of thiscontract.
Execution of clinical and non-clinical studies 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 resulting from execution of these
protocols, and final reports funded 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 that the Contractor provide any contract deliverable in a non-proprietary form toensure the Government has the ability to review and distribute the deliverables as theGovernment deems necessary.
Important information regarding performing human subject research is available at
http://www3.niaid.nih.gov/healthscience/clinicalstudies/
https://humansubjects.nih.gov/
Any updates to technical reports 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 performance.
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 Contractor;
they apply to all grants and contracts that involve non-clinical research.
a.

Safety and Monitoring Issuesi.

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 (IACUC) documentation of continuing review
and approval and the Office of Laboratory Animal Welfare (OLAW)
federal wide assurance number for the institution or site.
If 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 performing 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 within 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 46.102(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 effort. The Government
reserves the right to accompany the Contractor on site visits and/or
audits of CRO’s as C O 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 of IACUC 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 the study site,pharmacy service records on the dosing material to be used andexcipients, and laboratory services (including histopathology).
 Documentation that the Contractor and all required staff responsible forthe conduct of the research have received training in the protection andhandling of animals, or that the CRO has 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 justification 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 conjunction 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/grants/olaw/InvestigatorsNeed2Know.pdf
USDA Animal Welfare Act:
https://www.aphis.usda.gov/aphis/ourfocus/animalwelfare/sa awa/ct awa program infor
mation/!ut/p/z1/tVJNc4IwEP0tPXhkNnwoeARLxY60UxX5uGTCd1oIiCi1v75BD51pp1
IPzWVnk337dt8LBOBBwMiRZqSlFSMFz_1ggpfPykw01ohH00C6uVJt01xISFXAvVo
gyhDcht9aE16wcTZPmmgsptLf8OiXo6Mh_BYCCCLW1m0OPqlzusdRxdqEtbigYUOa
0wjtCa4ODU6r6LA Z4TRkhS4S4qUNMnlqiMjFLV9xHVTZQ0pMWVp1ZRnKXuWO
qIx-GM51FAspYIco6mgxIoihKEaCbGcSJI8TcVIJgOq8rGD60u7PdAL98Kfgo_ROLzIdWvDvP7QPSHVG0xrYpI2UM7pEmHTisF6GA9Y0aWAgeh9zj35O7naBzj3sXXtvwftHEzmd1NgzO-OLkDYXjfwLkDwrgD5IllRhVwF1wBf6Xbpiw516ThOqckn4W2ldZs0L45L62Nx9wkRThTc/dz/d5/L2dBISEvZ0FBIS9nQSEh/?urile=wcm%3Apath%3A%2Faphis content library%2Fsa_our_focus%2Fsa_animal_welfare%2Fsa_awa%2Fct_awa_program_information

2. Clinical Terms of Award
These Clinical Terms 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 clinical 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 awithout any restrictive legends to ensure the COR has the ability to review and distributethe deliverables, as COR deems necessary.
a.

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 IEC-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 IRB 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 participants enrolled in BARDA-fundedstudies, 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 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 starts.
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 toorganize an independent DSMB. All phase III clinical 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 BARDAsupported 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 IEC-approved clinical research protocol identified by version
number, date, or both, including details of study design, proposedinterventions, patient eligibility, and exclusion criteria.
 Documentation of IRB 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 trial 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

experiences:
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 will 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 theinstitutions’ office of sponsored programs, listing issues andappropriate actions to be discussed.
vi. Safety reporting for research not performed under an IND or IDE.

Final decisions regarding ongoing safety reporting 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 CFR Part 46 and with theContractor’s current Federal-wide Assurance (FWA) on file with 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 subjects
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 shall ensure that work is
conducted in a proper manner and as safely as is feasible. The parties hereto agree that theContractor retains the right to control and direct the 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 subcontractor, agent or employee of theContractor, or any other person, organization, institution, or group of any kind whatsoever.
The Contractor agrees that it has entered into this contract and will discharge its
obligations, duties, and undertakings 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 Contractor 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 are routinely engaged in research involving human 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/guidanceonalternativetofwa.pdf).
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 corrective action within the
period of time designated in the Contracting Officer’s written notice of suspension, theContracting Officer may, after consultation with OHRP, terminate 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) used
under this contract shall be obtained by the Contractor in full compliance 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, will be offered to any
person to influence their donation of human material.
The Contractor shall provide written documentation that all human materials obtained 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 Assurance tocomply with 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 "Protectionof Human Subjects Assurance Identification/IRB Certification/Declaration of
Exemption", Form OMB No. 0990-0263(formerly Optional Form 310), certifying IRB
review and approval of the protocol from which the human materials were obtained
constitutes the written documentation required. The human subject certification can be met
by submission of a self-designated form provided that it contains the information requiredby the "Protection of Human Subjects Assurance Identification/IRB
Certification/Declaration of Exemption", Form OMB No. 0990-0263 (formerly Optional
Form 310).
ARTICLE H.4. RESEARCH INVOLVING HUMAN FETAL TISSUE
All research involving human fetal tissue shall be conducted in accordance with the Public
Health Service Act, 42 U.S.C. 289g-1 and 289g-2. Implementing regulations and guidancefor conducting research on human fetal tissue may be found at 45 CFR 46, Subpart B andhttp://grants1.nih.gov/grants/guide/notice-files/not93-235.html and any subsequent
revisions to this NIH Guide to Grants and Contracts ("Guide") Notice.
The Contractor shall make available, for audit by the Secretary, HHS, the physician
statements and informed consents required by 42 USC 289g-1(b) and (c), or ensure HHS
access to those records, if maintained by an entity other than the Contractor.
ARTICLE H.5. CARE OF LIVE VERTEBRATE ANIMALS, HHSAR 352.270-5b(December 18, 2015)a.

Before undertaking performance of any contract involving animal-related activities where
the species is regulated by USDA, the Contractor shall register with the Secretary ofAgriculture 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.

The Contractor shall acquire vertebrate 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.

The Contractor agrees that the care, use and intended use of any live vertebrate animals
in the performance of this contract shall conform with the Public Health Service (PHS)
Policy on Humane Care of Use of Laboratory Animals (PHS Policy), the current
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 Subchapter A, Parts 1-4). In case of conflict between standards, the more
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 further 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 fails 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 approved Assurances.
Note: The Contractor may request registration of its facility and a current listing of licensed
dealers from the Regional Office of the Animal and Plant Health Inspection Service(APHIS), USDA, for the region in which its research facility is located. The location of
the appropriate APHIS Regional Office, as well as information concerning this program
may be obtained by contacting the Animal Care Staff, USDA/APHIS, 4700 River Road,
Riverdale, Maryland 20737 (E-mail: ace@aphis.usda.gov; W eb site:(http://www.aphis.usda.gov/animal_welfare).
ARTICLE H.6. ANIMAL WELFARE
All research involving live, vertebrate animals shall be conducted in accordance with the
Public Health Service Policy on Humane Care and Use of Laboratory Animals. This policy
may be accessed at:
http://grants1.nih.gov/grants/olaw/references/phspol.htm

ARTICLE H.7. INFORMATION ON COMPLIANCE WITH ANIMAL CAREREQUIREMENTS
Registration with the 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 Welfare Act (7 U.S.C. 2131 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.nih.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 animals 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, Subchapter A) https://awic.nal.usda.gov/final-rules-animal-welfare-9-cfr-parts-12-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 thatmeet the high standards are given the accredited status. As of the 2002 revision of the
PHS Policy, the only accrediting body recognized by PHS is the AAALAC. While
AAALAC Accreditation is not required 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, the organization shallfile, with the Office of Laboratory Animal Welfare (OLAW), National Institutes of
Health (NIH), a written Animal Welfare Assurance (Assurance) which commits theorganization to comply with the provisions of the PHS Policy, the Animal Welfare Act,and the Guide for the Care and Use of Laboratory Animals (National Academy Press,

Washington, DC). In accordance with the PHS Policy, applicant organizations must
establish an Institutional Animal Care & Use Committee (IACUC), qualified through theexperience and expertise of its members, to oversee the institution’s animal program,facilities and procedures. Applicant organizations are required to provide verification of
IACUC approval prior to release of an award involving live vertebrate animals. No award
involving the use of animals shall be made unless OLAW approves the Assurance andverification 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 Assurance andverification of IACUC approval are required. The Contracting Officer will request that
OLAW negotiate an acceptable Assurance with those Contractor(s) and request
verification of IACUC approval. For further information, contact OLAW at NIH, 6705
Rockledge Drive, RKL1, Suite 360, MSC 7982 Bethesda, Maryland 20892-7982 (E-mail:olaw@od.nih.gov; Phone: 301–496–7163).
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 Animal 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 will be made unless that individual is affiliated with an assuredorganization that accepts responsibility for compliance with the PHS Policy. Foreign
applicant organizations applying for PHS awards for activities involving vertebrate
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 informationthat is satisfactory to the USG to provide assurances for the humane care of such animals.
ARTICLE H.9. APPROVAL OF REQUIRED ASSURANCE BY OLAW
Under governing regulations, federal funds which are administered by the Department 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 vertebrate animals be involved in research activities by
the Contractor under this award unless a satisfactory assurance of compliance with 7
U.S.C. 2316 and 9 CFR Sections 2.25-2.27 is submitted within 30 days of the date of thisaward and approved by the Office of Laboratory Animal Welfare (OLAW). Each
performance site (if any) must also assure compliance with 7 U.S.C. 2316 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 live vertebrate animals) may be conducted by the Contractor orindividual performance sites pending OLAW approval of their respective assurance ofcompliance with 7 U.S.C. 2316 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 funded programs should report such matters to the HHS Inspector
General's Office in writing or on the Inspector General's Hotline. The toll free number is
1-800-HHS-TIPS (1-800- 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 of resources
and support to, individuals and organizations associated with terrorism. 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 will 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 determined by DHHS to be relevant to this contract in accordance with
FAR 52.227-14, Alternate 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 export 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 (ITAR) (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 firm 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 performance 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 suchtermination necessary to avoid an organizational conflict of interest. If the Contractor wasaware of a potential organizational conflict of interest prior to award or discovered an
actual or potential conflict after award and did not disclose it or misrepresented relevant
information to the Contracting Officer, the USG may terminate the contract for default,
debar the Contractor from USG contracting, or pursue such other remedies as may bepermitted 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 may 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 reporting 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 theContractor on how to maintain appropriate objectivity in the BARDA-funded research
project.
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 theContractor’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 information that may be available, the Contracting Officer may decidethat a particular 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 DISTRIBUTIONEXCHANGE HHSAR 352.270-12 (Dec2015)
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. CONTINUED BAN on FUNDING ABORTION AND
CONTINUED BAN OF FUNDING HUMAN EMBRYO RESEARCH HHSAR
352.270-13 (Dec 2015)(a) The Contractor shall not use any funds obligated under this contract for any abortion.
(b) The Contractor shall not use any funds obligated under this contract for the following:(1) The creation of a human embryo or embryos for research purposes; or(2) Research in which a human embryo or embryos are destroyed, discarded, or
knowingly subjected to risk of injury of death greater than that allowed for research on
fetuses in utero under 45 CFR Part 46 and Section 498(b) of the Public Health Service
Act (42 U.S.C. 289g(b)).
(c) The term “human embryo or embryos” includes any organism, not protected as ahuman subject under 45 CFR Part 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 of human diploid cells.
(d) The Contractor shall not use any Federal funds for the cloning of human beings.
Additionally, in accordance with a March 4, 1997 Presidential Memorandum, Federal
funds may not be used for cloning of human beings.

ARTICLE H.18. DISSEMINATION OF FALSE OR DELIBERATELYMISLEADING INFORMATIONThe Contractor shall not use contract funds to disseminate information that is deliberately
false or misleading.
ARTICLE H.19. CONFIDENTIALITY OF INFORMATIONa.

Confidential information, as used in this article, means information or data of apersonal nature about an individual, or proprietary information 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 information 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.20. ACCESS TO DOCUMENTATION/DATAThe 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 Subpart 27.4 and FAR Clause 52.227-14, Alternate
II.
ARTICLE H.21. 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, theequipment will run commercial off-the-shelf software both before and after recovery fromits energy conservation mode.
ARTICLE H.22. 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. HHSO100201600031C.
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 exeption 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 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. HHSO100201600031C.
ARTICLE H.23. 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 anofficer 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 information 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 current Department of Health and Human Services Appropriations Act provides thatno part of any appropriation contained in this Act shall be used, other than for normal 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 shall be used to pay the salary or
expenses of any contract or grant recipient, or agent acting for such recipient, related toany activity designed to influence legislation or appropriations pending before theCongress, or any State or Local legislature.
ARTICLE H.24. PRIVACY ACT APPLICABILITY
Notification is hereby given that the Contractor and its employees are subject to criminal
penalties for violation of the Privacy Act to the same extent as employees of the 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 Part 5b, Privacy Act Regulations, may beobtained at https://www.law.cornell.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 may be obtained at thefollowing link: http://oma.od.nih.gov/ms/privacy/pa-files/0200.htm
ARTICLE H.25. 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 under the contract.
ARTICLE H.26. 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 andnext 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 of reportcompletion.

ARTICLE H.27. 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 and COR.

ARTICLE H.28. 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.29. 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 within 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.30. 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://www1.od.nih.gov/oma/manualchapters/intramural/3044-2/
ARTICLE H.31. 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.32. 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 of Agriculture (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.html ) 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 information 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 CFRPart 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 transfer of Select Agents.
This includes summaries of safety, security, and training plans, and applicable laws,
regulations, and policies. For the purpose of security 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 Program Web site at http://www.selectagents.gov
ARTICLE H.33. MANUFACTURING STANDARDSThe Good Manufacturing Practice Regulations (GMP)(21 CFR Parts 210-211) will be thestandard to be applied for manufacturing, processing, packaging, storage and delivery ofthis product.
If at any time during the life of the contract, the Contractor fails to comply with GMP in
the manufacturing, processing, packaging, storage, stability and other testing of the
manufactured drug substance or product and delivery of this product and such failure
results in a material adverse effect on the safety, purity or potency of the product (amaterial 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.34. IN-PROCESS REVIEWIn Process Reviews (IPR) will be conducted at the discretion of the USG to discuss the
progression of the milestones. The USG reserves the right to revise the milestones andbudget pending the development of the project. Deliverables such as an overall projectsummary report and/or slides will 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 terminate
the work segment as otherwise permitted by this contract.

IPRs 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. Subsequently, thecontractor will be requested to provide a revised/final presentation to the Contracting
Officer at least 10 business days prior to the IPR.
H.35. PUBLIC ACCESS TO ARCHIVED PUBLICATIONS RESULTING FROMASPR FUNDED RESEARCHAll ASPR-funded investigators shall submit to the NIH 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 whole 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 forjournal publication, and includes all modifications from the publishing peer review
process. The PMC archive will preserve permanently these manuscripts for use by the
public, health care providers, educators, scientists, and ASPR. The Policy directs
electronic submissions to the NIH/NLM/PMC: http://www.pubmedcentral.nih.gov.
Additional information is available at
http://www.phe.gov/Preparedness/planning/science/Pages/AccessPlan.aspx(b) (4)PART II - CONTRACT CLAUSESSECTION I - CONTRACT CLAUSESARTICLE I.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 at:https://www.acquisition.gov/
Clauses for Cost-Reimbursement Research and Development Contracta. 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

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 (Over $150,000)
Contractor Code of Business Ethics and Conduct
Display of Hotline Poster(s)Contractor Employee Whistleblower Rights andRequirement To Inform Employees of Whistleblower
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 (Over$30,000)
Updates of Publicly Available Information Regarding
Responsibility Matters

FAR
CLAUSE NO.
52.209-10

DATE

TITLE

Nov 2015

52.210-1
52.215-2
52.215-8
52.215-10
52.215-11

Apr 2011
Oct 2010
Oct 1997
Aug 2011
Aug 2011

52.215-12
52.215-13

Oct 2010(Oct 2010)52.215-15
52.215-17
52.215-18

Oct 2010
Oct 1997
Jul 2005

52.215-19
52.215-21

Oct 1997
Oct 2010

52.215-21

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

April 1984
April 1984

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
Price Reduction for Defective Certified Cost or
Pricing Data—Modifications.
Subcontractor Cost or Pricing Data
Subcontractor Certified Cost or Pricing Data—
Modifications.
Pension Adjustments and Asset Reversions
Waiver of Facilities Capital Cost of Money
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
Requirements for Certified Cost or Pricing Data andData Other Than Certified 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

FAR
CLAUSE NO.
52.225-13
52.225-25

DATE

TITLE

Jun 2008
Oct 2015

52.227-1
52.227-2

Dec 2007
Dec 2007

52.227-11

May 2014

52.227-14
52.227-14 –Alternate II

May 2014
May 2014

Restrictions on Certain Foreign Purchases
Prohibition on Contracting with Entities Engaging in
Certain Activities or Transactions Relating to Iran—
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
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 HHSO100201600031C.
These data may be reproduced and used by theGovernment with the express limitation that they will
not, without written permission of the Contractor, be
used for purposes of manufacture nor disclosed
outside the Government; except that the Government
may disclose these data outside the Government for
the following purposes, provided that theGovernment makes such disclosure subject toprohibition 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.
52.227-14 –Alternate 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 theperformance 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
Insurance -- Liability to Third Persons
Administration of Cost Accounting Standards
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
52.228-7
52.230-6
52.232-9
52.232-17
52.232-20
52.232-23
52.232-25
52.232-33

Jun 1987
Mar 1996
June 2010
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
Sept 2006
Aug 1996
Oct 2004
May 2014
Apr 1984

FAR
CLAUSE NO.
52.242-3
52.242-4
52.242-13
52.243-2

DATE

TITLE

May 2014
Jan 1997
Jul 1995
Aug 1987

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)52.244-2
52.244-5
52.244-6
52.245-1
Alt. II
52.245-952.246-8

Oct 2010
Dec 1996
Feb 2016
Apr 2012

52.246-23
52.246-25
52.247-63
52.249-6
52.249-14
52.251-1
52.253-1

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

Apr 2012
May 2001

Use and Charges
Inspection of Research and Development – CostReimbursement
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
CLAUSE NO.
352.211-3
352.203-70
352.222-70

DATE

TITLE

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 I.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 milestones required for the exercise of a particular option
unless the Parties mutually agree to an earlier exercise of the option. The Government
will provide the Contractor a preliminary written notice of its intent to extend at least 30
days before the contract expires. The preliminary notice does not commit 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 period not to exceed six months under the clause at 52.217-9, Option
to Extend the Term of the Contract, or other appropriate authority.

Small business concern means a concern, including its affiliates, that is
independently owned and operated, not dominant in the field of operation inwhich it is bidding on Government contracts, and qualified as a small businessunder the criteria in 13 CFR part 121 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 which a number of business concerns are primarily 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, facilities, sales territory, and nature ofbusiness activity.
(b) If the 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 theoccurrence 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 inclusion of this clause in thecontract.
(2) Within 30 days after a merger or acquisition that does not require anovation or within 30 days 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 long-term contracts-(i) Within 60 to 120 days prior to 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 the time of this representation that corresponds 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 which itdoes not manufacture 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 status. The Contractor shall notify
the contracting office in writing within the timeframes specified 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 contract, 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 NAICS code applicable to thiscontract, the Contractor is required to complete the following representation andsubmit it to the contracting office, along with the contract number and the date on
which the representation was completed:
The Contractor represents that it [X] is, [ ] is not a small business concern under NAICS
Code 541711 assigned to contract number HHSO100201600031C.

FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors.
PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESSSUBCONTRACTORS (DEC 2013)(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 this clause, including this paragraph (c), in all
subcontracts with small business concerns, 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, dated 12 September 2016, 19 pages
2. Contract WBS Milestones/Deliverables and Technical Deliverables (see insidecontract)
3. Invoice/Financing Request Instructions and Contract Financial Reporting
Instructions for AMCG Cost-Reimbursement Type Contracts, 6 pages
4. Financial Report of Individual Project/Contract, 1 page
5. Instructions for Completing Financial Report of Individual Project/Contract, 3
pages
6. Inclusion Enrollment Report, 5/01 (Modified OAMP: 10/01), 1 page.
7. Research Patient Care Costs, 2 page
8. Disclosure of Lobbying Activities, 2 pages
9. Earned Value Management (EVM) Data Item Description (DID) Sample, 16
pages.
10. 7 Principles of Earned Value Management Tier 2 System Implementation Guide,
30 pages.
11. Listing of Project-Relevant Background Inventions
12. Data Rights Assertion Table

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

BARDA Broad Agency Announcement (BAA)(Solicitation # CBRN-BAA-13-100-SOL-00013)
Advanced Research and Development of Chemical, Biological, Radiological and Nuclear
Medical Countermeasures
Topic Area of Interest No. (#1), Vaccines
MANUFACTURING AND LICENSURE OF BPSC1001/V920 (rVSVΔG-ZEBOV-GP)

Statement of Work
PREAMBLE
Independently and not as an agency of the Government, the Contractor shall be
required to furnish all the necessary services, qualified personnel, material, equipment,
and facilities, not otherwise provided by the Government, as needed to perform theStatement of Work submitted in response to the BARDA Broad Agency Announcement(BAA) BARDA CBRN BAA-13-100-SOL-00013.
The Government reserves the right to modify the milestones, progress, schedule,
budget, or deliverables to add or delete deliverables, process, or schedules if the needarises. Because of the nature of this research and development (R&D) contract and thecomplexities inherent in this and prior programs, at designated milestones theGovernment will evaluate whether work should be redirected, removed, or whether
schedule or budget adjustments should be made. The Government reserves the right tochange the product, process, schedule, or events to add or delete part or all of theseelements as the need arises, and upon reaching agreement with the Contractor
regarding any required change.
(b) (4)

BioProtection Systems(b) (4)

Statement of Work and Work Breakdown Structure
1. Base: Facility, Site, Process Performance Qualification (PPQ) Readiness Activities,
Manufacturing and Testing of Process Simulations
The BASE contract will support the necessary activities at the final commercial
manufacturing facility at the expected commercial process scale (400RB process).
The proposal thus includes:(b) (4)2

BioProtection Systems
 (b) (4)1.1. Program Management (WBS1.1)
The Contractor [BioProtection Systems Inc. (BPS)] shall provide for the following
as outlined below and in the contract deliverables list (Article F.2):
1.1.1. The overall management, integration and coordination of all contract
activities, including a technical and administrative infrastructure toensure the efficient planning, initiation, implementation, and direction of
all contract activities;
1.1.2. Principal Investigator (PI) responsible for project management,
communication, tracking, monitoring and reporting on status andprogress, and modification to the project requirements and timelines,
including projects undertaken by subcontractors; The contract3

BioProtection Systems
deliverables list (reference), identifies all contract deliverables andreporting requirements for this contract.
1.1.3. Project Manager(s) with responsibility for monitoring and tracking dayto-day progress and timelines, coordinating communication and project
activities; costs incurred; and program management; The contract
deliverables list (reference), identifies all contract deliverables andreporting requirements for this contract.
1.1.4. BARDA Liaison with responsibility for effective communication with the
Project Officer and Contracting Officer. May be the PI or ProjectManager.
1.1.5. Administrative and legal staff to provide development of compliant
subcontracts, consulting, and other legal agreements, and to ensure
timely acquisition of all proprietary rights, including IP rights, andreporting all inventions made in the performance of the project.
1.1.6. Administrative staff with responsibility for financial management andreporting on all activities conducted by the Contractor and any
subcontractors.
1.1.7. Contract Review Meetings
1.1.7.1 The Contractor shall participate in regular meetings tocoordinate and oversee the contract effort as directed by theContracting and Project Officers. Such meetings may include,
but are not limited to, meeting of the Contractors andsubcontractors to discuss manufacturing progress, productdevelopment, product assay development, scale up
manufacturing development, clinical sample assays
development, preclinical/clinical study designs and regulatory
issues; meetings with individual contractors and other HHS
officials to discuss the technical, regulatory, and ethical aspectsof the program; and meeting with technical consultants todiscuss technical data provided by the Contractor.
1.1.7.2 The Contractor shall participate in teleconferences every two
weeks between the Contractor and subcontractors (as required)and BARDA to review technical progress. Teleconferences oradditional face-to-face meetings shall be more frequent at therequest of BARDA.
1.1.8. Integrated Master ScheduleWithin 30 calendar days of the effective date of the contract, theContractor shall submit a first draft of an updated Integrated Master
Schedule in a format agreed upon by BARDA to the Project Officer and4

BioProtection Systems
the Contracting Officer for review and comment. The Integrated Master
Schedule shall be incorporated into the contract, and will be used tomonitor performance of the contract. Contractor shall include the key
milestones and Go/No Go decision gates. The IMS for the period of
performance will be accepted by BARDA at the PMBR.
1.1.9. Integrated Master Plan
Work Breakdown Structure
The Contractor shall utilize a WBS template agreed upon by BARDA for
reporting on the contact. The Contractor shall expand and delineate theContract Work Breakdown Structure (CWBS) to a level agreed upon by
BARDA as part of their Integrated Master Plan for contract reporting.
The CWBS shall be discernable and consistent. BARDA may require
Contractor to furnish WBS data at the work package level or at a lower
level if there is significant complexity and risk associated with the task.
GO/ NO-GO Decision Gates:
The Integrated Master Plan outlines key milestones with “Go/No Go”
decision criteria (entrance and exit criteria for each phase of the
project). The project plan should include, but not be limited to,milestones in manufacturing, non-clinical and clinical studies, andregulatory submissions. Specific milestones will be defined that will be
used to trigger subsequent Option Periods.
1.1.10. Program Management Plan
Within 3 months of contract award, the Contractor will develop, andsubmit to BARDA for approval, a revised version of the Program
Management Plan (PMP) that was initially submitted to HHS undercontract No. HSSO100201500002C. The revised plan will detail thetools and techniques that BPS intends to employ in its management of
the proposed work.
This plan is intended to be a living document and changes to any of theindividual sub-plans as well as the addition or subtraction of sub-plans
will be documented and must be approved by the Program Manager
and Principal Investigator. Changes to the PMP will be tracked byversion number and date, and assuming changes have been made, will
be submitted to BARDA for review and approval.
The Program Management Plan will update the following individual
sub-plans:
5

BioProtection Systems


Scope/Schedule Management Plan

Costs Management Plan

Communications Management Plan

Stakeholder Management Plan



Change Management Plan

Quality Management Plan

Human Resources/Staffing Plan

1.1.11. Product Development Plan
Within 3 months of the effective date of subcontract award, theContractor will submit a revised version of the Integrated ProductDevelopment Plan (IPDP) that was initially submitted to HHS undercontract No. HSSO100201500002C. Ultimately, this plan will requireapproval by BARDA’s Contracting Officer's Representative and theContracting Officer prior to initiation of any activities related to theirimplementation. This plan will be updated, as required.
1.1.12. Subcontractor Management
The Contractor will manage all subcontractors to oversee effective andtimely execution of deliverables in the scope of work and to meet
reporting requirements under this contract.
(b) (4)1.1.13. Financial Management, Accounting and Reporting
The Contractor will engage a subcontractor to provide specific services
in Contracts and Subcontracts Management to help ensure compliancewith contracts clauses and requirements, Federal Acquisition
Regulations; and purchasing. Specific services will include:

Subcontract Requests for ProposalContracts reporting and monitoringContracting Office Consent to SubcontractPrice Reasonableness analysis

Internal Controls
6

BioProtection Systems
To the extent required by the contract, the Contractor will develop,
implement, and provide ongoing support to the contract Earned ValueManagement (EVM ) reporting. This will include the design andimplementation of processes, documentation, control account plans,
and the Performance Measurement Baseline (PMB) enabling theimplementation of a software solution. Further, the Contractor and/or
its subcontractor will support the monthly EVM processing andreporting and format 5 variance reporting
The Contractor and/or its subcontractor will provide Project Accounting
and Finance Management to help ensure compliance with contracts
clauses and requirements, Federal Acquisition Regulations; and costaccounting and billing. Specific services will include:Monthly Job Cost reporting and billingTime Reporting

Indirect Rate calculationsInternal Controls and training



QA/QC Plans and Ongoing activity

Elements of EVMS shall be applied to all CLINs as part of the Integrated
Master Project Plan, the Contractor shall submit a written summary of
the management procedures that it will establish, maintain and use tocomply with EVMS requirements. This summary is provided as an
Attachment to this proposal.
1.1.14. Decision Gate Reporting
On completion of a stage of the product development, as defined in theagreed upon Integrated Master Schedule and Integrated Master Plan,
the Contractor shall prepare and submit to the Project Officer and theContracting Officer a Decision Gate Report that contains (i) sufficientdetail, documentation and analysis to support successful completion of
the stage according to the predetermined qualitative and quantitative
criteria that were established for Go/No Go decision making; and (ii) a
description of the next stage of product development to be initiatedand a request for approval to proceed to the next stage of productdevelopment.
1.1.15. Risk Management Plan
The Contractor shall develop a risk management plan within 90 days ofcontract award highlighting potential problems and/or issues that may
arise during the life of the contract, their impact on cost, schedule andperformance, and appropriate remediation plans. This plan should
7

BioProtection Systems
reference relevant WBS elements where appropriate. Updates to thisplan shall be included every three months (quarterly) in the monthly
Project Status Report.
1.1.16. Quality Management Plan
Within 3 months of contract award, the Contractor will update, andsubmit to BARDA for approval, a revised quality plan for the program toensure compliance with specified requirements, guidance documents
and GCP/GMP/GLP regulations; and to ensure continual improvement.
The quality plan will:•

Describe the quality planning process;•Establish quality objectives;•

Identify quality system changes in alignment with compliancerequirements, contractual requirements and operational
requirements; and•Ensure comprehensive quality oversight of the subcontractors
through documentation reviews and quality system compliance
audits.

This quality plan will be maintained by the BPS quality lead who will be
responsible for assuring that all quality objectives are appropriately
documented and accomplished. This quality plan may besupplemented with additional, separate implementation plans andschedules.
The Contractor will manage the program’s quality activities according
to the approved quality plan.
1.1.17. Performance Measurement Baseline Review (PMBR):
The Contractor shall submit a plan for a PMBR to occur within 180 daysof contract award. At the PMBR, the Contractor and BARDA shallmutually agree upon the budget, schedule and technical plan baselines(Performance Measurement Baseline). These baselines shall be thebasis for monitoring and reporting progress throughout the life of thecontract. The PMBR is conducted to achieve confidence that thebaselines accurately capture the entire technical scope of work, areconsistent with contract schedule requirements, are reasonably andlogically planned, and have adequate resources assigned. The goals of
the PMBR are as follows:

Jointly assess areas such as the Contractor’s planning for complete
coverage of the SOW, logical scheduling of the work activities,
adequate resources, and identification of inherent risks
8

BioProtection Systems


Confirm the integrity of the Performance Measurement Baseline
(PMB)



Foster the use of EVM as a means of communication

Provide confidence in the validity of Contractor reporting

Identify risks associated with the PMB

Present any revised PMBs for mutual agreement



Present an Integrated Master Schedule: The Contractor shalldeliver an initial program level Integrated Master Schedule (IMS)
that rolls up all time-phased WBS elements down to the activity
level. This IMS shall include the dependencies that exist between
tasks. This IMS will be agreed to and finalized at the PMBR. DIMGMT-81650 may be referenced as guidance in creation of the
IMS (see http://www.acq.osd.mil/pm/).

Present the Risk Management Plan

1.1.18. Deviation Request:
During the course of contract performance, in response to a need tochange IMS activities as baselined at the PMBR, the Contractor shallsubmit a Deviation Report. This report shall request a change in theagreed-upon IMS and timelines. This report shall include: (i) discussionof the justification/rationale for the proposed change; (ii) options foraddressing the needed changes from the agreed upon timelines,
including a cost-benefit analysis of each option; and (iii)
recommendations for the preferred option that includes a full analysis
and discussion of the effect of the change on the entire productdevelopment program, timelines, and budget.
1.1.19. Monthly and Annual Reports
The Contractor shall deliver Project Status Reports on a monthly basis.
The reports shall address the items below cross referenced to the WBS,
SOW, IMS, and EVM:

Executive summary highlighting the progress, issues, and relevant
activities in manufacturing, non-clinical, clinical, and regulatory;Progress in meeting contract milestones, detailing the planned
progress and actual progress during the reporting period,
explaining any differences between the two and corrective steps;

Updated IMS;

Updated EVM;
9

BioProtection Systems


Updated Risk Management Plan (Every 3 months);

Three month rolling forecast of planned activities;



Progress of regulatory submissions;

Estimated and actual expenses;

1.1.20. Data Management
The Contractor shall develop and implement appropriate data
management and quality control systems/procedures, includingtransmission, storage, confidentiality, and retrieval of all contract data;
Provide for the statistical design and analysis of data resulting from theresearch;
1.1.21. Long-term Stability Testing, 90 Roller Bottle Drug Product Lots Produced
Under Contract HHS0100201500002C(b) (4)1.1.22. Long-term Storage Testing, 90 Roller Bottle Drug Product Lots
Produced Under Contract Modification HHS0100201500002C(b) (4)10

BioProtection Systems(b) (4)1.2. Process Performance Qualification (PPQ) Readiness Activities (WBS 1.2)
The contractor and/or its subcontractor(s) will conduct PPQ readiness activities
to generate necessary documents and data to support process validation and tosupport a Biological License Application (BLA) for BPSC1001/V920 (rVSV∆GZEBOV-GP manufacturing.
This shall include: (b) (4)1.3. Facility and Site Readiness Activities (WBS 1.3)
The contractor and/or its subcontractor(s) shall complete the necessary facility
upgrades and implementation of quality systems to support cGMP production of
the Ebola Zaire Vaccine BPSC1001/V920 (rVSV∆G-ZEBOV-GP). The scope of thisWBS shall include: (b) (4)11

BioProtection Systems(b) (4)1.4. Manufacture and Testing of Process Simulations (WBS 1.4)
Complete the necessary three consecutive end-to-end Process Simulations for
DS and DP product with the expected commercial process.
Activities include: (b) (4)1.5. Regulatory (WBS 1.5)
This activity will largely be performed pre-award and no costs are assigned to thework.
Engage CBER in formal Type C meeting to discuss following topics:
 (b) (4)12

BioProtection Systems
 (b) (4)1.6. Non-Clinical: Reproductive Toxicology Studies (WBS 1.6)
1.6.1. Embryo-fetal Development Study in Pregnant Female Rats (WBS 1.6.2)
The contractor and/or its subcontractor(s) will conduct a GLPembryofetal development study to evaluate the potential
developmental toxicity profile for BPSC1001/V920 (rVSVΔG-ZEBOV-GP).
The study design (either single or multiple doses) will be based upon
the results of an exploratory immunogenicity study (funded outside ofthis proposal) using the dosing regimen that produces the greatest
viremia in rats.
Activities include GLP protocol development, study conduct, generationof an un-audited report, and completion of the final study report. An
initial study design has been discussed with FDA and deemed to beappropriate.
1.6.2. Pre- and Post-natal Development Study in Rats (WBS 1.6.3)
The contractor and/or its subcontractor(s) will conduct a pre- and postnatal development study to evaluate the potential effects of
BPSC1001/V920 (rVSVΔG-ZEBOV-GP) on development, growth,
behavior, and reproductive performance of the F1 generation. The
study design (either single or multiple doses) will be based upon the
results of an exploratory immunogenicity study using the dosing
regimen that produces the greatest viremia. Activities include GLP
protocol development, study conduct, generation of an un-audited
report, and completion of the final study report. An initial study design
has been discussed with FDA and deemed to be appropriate.
1.6.3. Testing of Rat Specimens in Qualified RT-PCR Assays (WBS 1.6.4)
Samples from these studies will be tested in the immunogenicity assay
as well as the qualified BPSC1001/V920 (rVSVΔG-ZEBOV-GP) real-time
RT-PCR assay to detect potential viremia of the vaccine virus in the sera
collected at different time points post vaccination.
1.7. Immunogenicity for PREVAIL and PREPARE Studies (WBS 1.7)

13

BioProtection Systems(b) (4)

2. Option 1: Manufacturing and Testing of PPQ Lots, BLA Preparation and Pre-PAI
Activities
Go/No Go Decision Criteria: Option 1. Go/No Go Decision Criteria: Completion of
construction of the Drug Substance (DS) production facility. Finalization of the
Validation Master Plan. Finalization of the DS Process Simulation protocol andInitiation of the DS Process Simulations. The decision gate may include a site visit by
BARDA to the manufacturing facility .
The Contractor and/or its subcontractor(s) shall carry out the following tasks andsubtasks and in accordance with the agreed upon Integrated Master Schedule andIntegrated Master Plan (defined in 4.1.1.2 and 4.1.1.3) which shall further detail the
conduct of the specific tasks and subtasks.
2.1 Program Management (consistent with section 1.1.1) (WBS 2.1)
Program management scope in BASE year is consistent with program management
scope in each option year.
2.2 Manufacturing and Testing of Process Performance Qualification (PPQ) Lots
(WBS 2.2)
These activities will provide the necessary information to show the commercial
process is robust and reproducible.
These lots are necessary for BLA Submission. The Contractor and/or its
subcontractor(s) will perform the following activities:

14

BioProtection Systems
 (b) (4)15

BioProtection Systems
 (b) (4)2.3 BLA Preparation and Pre-PAI Activities (WBS 2.3)
Following completion of Process Performance Qualification lots, the contractor
and/or its subcontractor(s) shall complete the necessary activities anddocumentation to support BLA licensure for the Ebola Vaccine BPSC1001/V920(rVSV∆G-ZEBOV-GP). These shall include: (b) (4)

3. Option 2: Pediatric Clinical Trial(b) (4)16

BioProtection Systems(b) (4)

3.1 Program Management (Consistent with section 4.1.1.1) (WBS 4.1)
Program management scope in BASE year is consistent with program management
scope in each option year.
(b) (4)(b) (4)17

BioProtection Systems
o (b) (4)4. Option 3: Additional Process Simulations and Manufacturing of PPQ Lots
Go/No Go Decision Criteria: Option 3 will be considered if additional process simulation
and/or Process Performance Qualification Lots are needed. This decision will beconsidered after completion of all milestones under WBS 1.4, and again after all
milestones under WBS 2.2 (if Option 2 should be exercised).
The contractor and/or its subcontractor(s) shall carry out the following tasks andsubtasks and in accordance with an agreed upon Integrated Master Schedule andIntegrated Master Plan (defined in 4.1.1.2 and 4.1.1.3) which shall further detail the
conduct of the specific tasks and subtasks.
4.1 Program Management (Consistent with section 1.1.1) (WBS 6.1)
Program management scope in BASE year is consistent with program management
scope in each option year.
(b) (4)18

BioProtection Systems
 (b) (4)19

BioProtection Systems

20

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 submit invoices/financing requests more frequently than every two weeks when authorized by theContracting Officer.
Cost Incurrence 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 (COA) 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 B and 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.

(l)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, identify 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.
The 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)

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.

(q)

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)

Total Amounts Claimed: Insert the total amounts claimed for the current and cumulative periods.

(t)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 H of 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 F isblank. 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.

89

90

91

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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 payors (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 payors or patients and which are consistent withthe terms and conditions of the contract are chargeable to this contract.

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 required for each payment or agreement to makepayment to any lobbying entity for influencing or attempting to influence an officer or employeeof 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 appropriateclassificationof 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 organizationallevel 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 full 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 full names of the individual(s) performing services, and include full address if different from 10 (a). Enter Last Name, First Name, andMiddle Initial (MI).
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 OMB Control
Number. The valid OMB control number for this information collection is OMB 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 completing 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

DI-MGMT-81466A
DID, DI-FNCL-81566A. The same WBS shall be utilized for the Integrated Master
Plan (IMP), IMS, CPR, and Contractor Cost Data Report (CCDR) as applicable.
c. The CPR shall be used to obtain cost and schedule performance informationon contracts requiring compliance with the American National Standards
Institute/Electronic Industries Alliance Standard 748 (ANSI/EIA-748), Earned
Value Management Systems (EVMS) (current version in effect at time of contract
award). Refer to the Federal Acquisition Regulation (FAR) or Defense Federal
Acquisition Regulation Supplement (DFARS) clause on contract. The CPR data
elements shall reflect the output of the contractor's ANSI/EIA-748 compliant
integrated management system.
d. The CPR shall be required no less frequently than monthly. All formats
shall be submitted to the procuring activity no later than 12 working days
following the contractor’s accounting period cutoff date. This requirement
may be tailored through contract negotiations to allow submission as late as
17 working days, provided that the contractor and Government agree that
program complexity and integration of subcontractor and vendor performancedata warrant additional time and will yield more accurate performance.
Reports may reflect data either as of the end of the calendar month or as of
the contractor's accounting period cutoff date, provided it is consistent with
the IMS. Formats 2, 3, and 4 may be submitted on a less frequent basis insome cases. Refer to the Earned Value Management Implementation Guide (EVMIG)
for guidance on tailoring reporting. (Note: Contractors may elect to attach
subcontractor Format 5 reporting and cross reference this analysis in theFormat 5 reporting submitted to the Government to gain time efficiencies andmeet submission dates.)e. Unless otherwise provided in the contract, data reported in the CPR shallpertain to all authorized contract work, including both priced and unpriced
effort. Refer to the EVMIG for guidance on tailoring reporting.
f. Submission of Format 1 using a product-oriented WBS in accordance with the
WBS Handbook, MIL-HDBK-881, and the CWBS DID, DI-MGMT-81334A, is mandatory.
(Note: For contracts that require CCDRs, the CWBS shall be developed,
approved, and maintained in accordance with DoD 5000.4-M-1, Cost and Software
Data Reporting Manual, and the CWBS DID.) Certain aspects of the report are
subject to negotiation between the Government and the contractor, such as:f.l The level of detail to be reported in Format 1 normally will be at level
three of the CWBS, but lower levels may be specified for high-cost or highrisk items. The Government and the contractor shall periodically review andadjust as necessary CWBS reporting levels on Format 1 to ensure they continue
to provide appropriate visibility without requiring excessive information. If
there is a significant problem at a lower level, detailed reporting for that
CWBS element may be required until the problem is resolved.
f.2 Formats 1 and 5 are mandatory in all 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 problem analysis
and narrative explanations in Format 5. If the contract does not specify
variance analysis thresholds, the contractor shall provide appropriate
variance analyses. (See 2.6.3 below.) Variance analysis thresholds shall be
reviewed periodically and adjusted as necessary to ensure they continue toprovide appropriate visibility.

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f.4 If the organizational categories for Format 4 are different from Format
2, the Government may request that different organizational categories be used
for reporting staffing in Format 4 instead of those used in Format 2. If so,
the Government and the contractor shall negotiate the Format 4 categories. If
required, the Format 2 categories shall reflect the contractor's internalorganization being used to execute the contract.
g. Subject to f., the CPR Contract Data Requirements List (CDRL) is subject
to tailoring. Requiring more information in the CPR CDRL than specified inthis DID is contrary to DoD policy. All negotiated reporting provisions shallbe specified in the contract. Refer to the EVMIG for guidance on tailoring
reporting.
REQUIREMENTS:
1. Format. Use the relevant DD Forms as listed above. All formats shall be
submitted electronically in accordance with the following requirements. Allformats shall be in a readable digital format (e.g., pdf files are notacceptable). The American National Standards Institute (ANSI) X12 standard(839 transaction set), the United Nations Electronic Data Interchange for
Administration, Commerce and Transport (UN/EDIFACT) standard (PROCST message),or the XML equivalent shall be used to submit data electronically to the
procuring activity. Contractor formats may be substituted whenever they
contain all of the required data elements at the specified reporting levels
and are compliant with the X12 standard, XML schema, or equivalent. On-line
access to the data may be provided to augment formal CPR submission. (Note:
Until the ANSI X12/XML standards are redefined to incorporate the changes tothe forms, the new data elements shall be reported in Format 5.)2.

Content.

The CPR shall contain the following:

2.1 Heading Information - Formats 1 - 5. Preparation instructions for
Heading Information (Blocks 1 through 4) apply to Formats 1 through 5.
2.1.1 Contractor. Enter in Block 1.a the contractor's name and division (ifapplicable). Enter in Block 1.b the facility location and mailing address of
the reporting contractor.
2.1.2 Contract. Enter the contract name in Block 2.a, the contract number(and the applicable Contract Line Item Number(s) (CLIN(s)) in Block 2.b, thecontract type in Block 2.c, and the contract share ratio (if applicable) in
Block 2.d.
2.1.3 Program. Enter in Block 3.a the program name, number, acronym, type,model, and series, or other designation of the prime item(s) purchased under
the contract. Indicate the program phase (development, production, etc.) in
Block 3.b. Indicate whether the contractor’s EVMS has been accepted by theGovernment and the date of the acceptance.
2.1.4 Report Period. Enter the beginning date in Block 4.a and the ending
date in Block 4.b of the period covered by the report.
2.1.5 Security Classification. Enter the appropriate security classification
at the top and bottom of each page.
. If reported dollar amounts are in thousands,
2.1.6 Dollars inmillions, or billions, enter the factor at the top of each page.

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DI-MGMT-81466A
2.2

Format 1 - Work Breakdown Structure.

2.2.1

Contract Data.

2.2.1.1 Quantity. Enter in Block 5.a the number of principal items to be
procured on this contract.
2.2.1.2 Negotiated Cost. Enter in Block 5.b the dollar value (excluding fee
or profit) on which contractual agreement has been reached as of the cutoff
date of the report. For an incentive contract, enter the definitized contract
target cost. Amounts for changes shall not be included in this item until
they have been priced and incorporated in the contract through contract changeorder or supplemental agreement. For a cost plus fixed fee, award fee, or
incentive fee contract, enter the estimated cost negotiated. Changes to theestimated cost shall consist only of estimated amounts for changes in thecontract scope of work, not for cost growth ("overrun") above the original
estimated cost.
2.2.1.3 Estimated Cost of Authorized, Unpriced Work. Enter in Block 5.c theamount (excluding fee or profit) estimated for that work for which written
authorization has been received, but for which definitized contract prices
have not been incorporated in the contract through contract change order or
supplemental agreement.
2.2.1.4 Target Profit/Fee. Enter in Block 5.d the fee or percentage of
profit that shall apply if the negotiated cost of the contract is met. (See
2.2.1.2 above.)2.2.1.5 Target Price. Enter in Block 5.e the target price (negotiatedcontract cost plus profit/fee) applicable to the definitized contract effort.
2.2.1.6 Estimated 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 final
contract price (total estimated cost to the Government). This number shall bebased on the most likely management EAC in Block 6.c.1 and normally willchange whenever the management estimate or the contract is revised.
2.2.1.7 Contract Ceiling. Enter in Block 5.g the contract ceiling priceapplicable to the definitized effort.
2.2.1.8 Estimated Contract Ceiling. Enter in Block 5.h the estimated ceiling
price applicable to all authorized contract effort including both definitized
and undefinitized effort.
2.2.1.9 Over Target Baseline/Over Target Schedule. Enter in Block 5.i thedate the last over target baseline or over target schedule was implemented (ifapplicable).
2.2.2 Estimated Cost at Completion. These blocks shall present thecontractor's range of estimated costs at completion. The range of estimatesis intended to allow contractor management flexibility to express possible
cost outcomes. Contractors shall provide the most accurate Estimates atCompletion (EACs) possible through program-level assessments of factors that
may affect the cost, schedule, or technical outcome of the contract. Suchprogram-level assessments shall include consideration of known or anticipatedrisk areas, and planned risk reductions or cost containment measures. EACs
shall be reported without regard to contract ceiling.

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DI-MGMT-81466A
2.2.2.1 Management Estimate at Completion - Best Case. Enter in Block 6.a.1
the contractor's best case EAC. The best case estimate is the one that
results in the lowest cost to the Government. This estimate shall be based on
the outcome of the most favorable set of circumstances. If this estimate isdifferent from the most likely EAC (Block 6.c.1), the assumptions, conditions,and methodology underlying this estimate shall be explained briefly in Format
5. This estimate is for informational purposes only; it is not an official
company estimate. There is no requirement for the contractor to prepare andmaintain backup data beyond the explanation provided in Format 5.
2.2.2.2 Management Estimate at Completion - Worst Case. Enter in Block 6.b.1
the contractor's worst case EAC. The worst case estimate is the one that
results in the highest cost to the Government. This estimate shall be basedon the outcome of the least favorable set of circumstances. If this estimate
is different from the most likely EAC (Block 6.c.1), the assumptions,conditions, and methodology underlying this estimate shall be explained
briefly in Format 5. This estimate is for informational purposes only; it is
not an official company estimate. There is no requirement for the contractor
to prepare and maintain backup data beyond the explanation provided in Format
5.
2.2.2.3 Management Estimate at Completion - Most Likely. Enter in Block
6.c.1 the contractor's most likely EAC. This estimate is the contractor's
official contract EAC and, as such, takes precedence over the estimatespresented in Column (15) of Formats 1 and 2 and Blocks 6.a.1 and 6.b.1. ThisEAC is the value that the contractor's management believes is the most likely
outcome based on a knowledgeable estimate of all authorized work, known risks,and probable future conditions. This value need not agree with the total of
Column (15) (Block 8.e). However, any difference shall be explained in Format
5 in such terms as risk, use of Management Reserve (MR), or higher management
knowledge of current or future contract conditions. The assumptions,conditions, and methodology underlying this estimate shall be explained
briefly in Format 5. This EAC need not agree with EACs contained in thecontractor's internal data, but must be reconcilable to them. The most likely
EAC shall also be reconcilable to the contractor's latest statement of funds
required as reported in the CFSR, or its equivalent, if this report is acontractual requirement.
2.2.2.4 Contract Budget Base. Enter in Block 6.c.2 the total of negotiatedcost (Block 5.b) and estimated cost of authorized, unpriced work (Block 5.c).
2.2.2.5 Variance. Enter in Block 6.c.3 the Contract Budget Base (Block
6.c.2) minus the most likely estimate at complete (Block 6.c.1). This value
shall be explained in Format 5 according to applicable contractual
requirements.
2.2.3 Authorized Contractor Representative. Enter in Block 7.a the name of
the authorized person (program manager or designee) signing the report. Enter
that person's title in Block 7.b. The authorized person shall sign in Block
7.c. Enter the date signed in Block 7.d. Electronic signatures areencouraged.
2.2.4

Performance Data.

2.2.4.1 Column (1) - Work Breakdown Structure Element. Enter in Column (1)of Block 8.a the noun description of the CWBS items for which cost information
is being reported. CWBS elements and levels reported shall be those specified
in the contract. (See f.1 above.)

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2.2.4.2 Cost of Money. Enter in Columns (2) through (16) of Block 8.b the
Facilities Capital Cost of Money applicable to the contract.
2.2.4.3 General and Administrative. Enter in Columns (2) through (16) of
Block 8.c the appropriate General and Administrative (G&A) costs. If G&A
costs have not been included in 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
included in the CWBS costs reported in Block 8.a above, G&A shall be shown asa non-add entry in Block 8.c with an appropriate notation to that effect. For
contracts that require CCDRs, contractors may also have to submit separate
costs without G&A for the CWBS elements reported in Block 8.a on an exception
basis if the Government specifies such a requirement in the CDRL. If a G&Aclassification is not used, no entry shall be made other than an appropriate
notation to that effect.
2.2.4.4 Undistributed Budget. Enter the amount of budget applicable tocontract effort that has not yet been identified to CWBS elements at or below
the reporting level. For example, if contract changes were authorized late in
the reporting period, they should have received a total budget; however,assignment of work and allocation of budgets to individual CWBS elements may
not have been accomplished as of the contractor’s accounting period cutoff
date. Budgets that can be identified to CWBS elements at or below thespecified reporting level shall be included in the total budgets shown for the
CWBS elements in Block 8.a and shall not be shown as Undistributed Budget(UB). Enter in Column (15) of Block 8.d the EAC for the scope of work
represented by the UB in Column (14) of Block 8.d. Enter in Column (16) of
Block 8.d the variance, if any, and fully explain it in Format 5. The
reason(s) for UB shall be fully explained in Format 5.
2.2.4.4.1 Use of Undistributed Budget. UB is used to accommodate temporary
situations where time constraints prevent adequate budget planning or wherecontract effort can only be defined in very general terms. UB shall not be
used as a substitute for adequate contract planning. Formal budgets shall beallocated to contract effort and responsible organizations at the earliest
possible time, preferably within the next reporting period.
2.2.4.5 Subtotal (Performance Measurement Baseline). In Columns (2) through(16) of Blocks 8.a through 8.e, enter the sum of the costs and budgets for
direct, indirect, cost of money, and G&A. This subtotal represents thedollars in the allocated budget (less MR), which is the Performance
Measurement Baseline (PMB) against which performance is measured.
2.2.4.6 Management Reserve. MR is an amount of the overall contract budget
withheld for management control purposes and is held for program unknowns(realized risks on authorized work scope). Reserve is held for future needs
and shall not be used to offset cumulative cost variances. It shall not be
eliminated from contract prices by the Government during subsequent
negotiations nor used to absorb the cost of contract changes. In Column (14)of Block 8.f enter the total amount of budget identified as MR as of the endof the current reporting period. The amounts shown as MR in Formats 1, 2, and3 should agree. Amounts of MR applied to CWBS elements during the reporting
period shall be listed in Block 6.b of Format 3 and explained in Format 5.
2.2.4.6.1 Negative Management Reserve. Negative entries shall not be made inManagement Reserve (Column (14) of Block 8.f). There is no such thing as"negative MR." If the contract is budgeted in excess of the Contract Budget
Base (the negotiated contract cost plus the estimated cost for authorized,
unpriced work), the provisions applicable to formal reprogramming and the
instructions in paragraphs 2.2.5.1, 2.2.6.6, 2.2.6.7, and 2.4.1.7 apply.

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2.2.4.7 Total. Enter the sum of all direct, indirect, cost of money, and G&A
costs, and UB and MR (if applicable) in Columns (2) through (14) of Block 8.g.
The Total lines of Format 1 (Block 8.g) and Format 2 (Block 5.g) should agree.
The total of Column (14), Block 8.g, should equal the Total Allocated Budget
shown in Block 5.f on Format 3.
2.2.5

Reconciliation to Contract Budget Base.

2.2.5.1 Formal Reprogramming. In exceptional cases, the contractor may
establish performance measurement budgets that exceed the Contract Budget
Base. Acceptance of the new baseline in excess of the Contract Budget Basewill be predicated on Government approval. This process is called formal
reprogramming. The contractor and the Government shall agree on how theresults of a formal reprogramming will be reported in the CPR before theformal reprogramming is initiated. This agreement and any other pertinentdetails on the reporting of the formal reprogramming shall be included inFormat 5. Blocks 9.a and 9.b are used to reconcile the higher performancemeasurement budgets, also called an "over target baseline," to the Contract
Budget Base. (See 2.2.6.6, 2.2.6.7, 2.4.1.7, and 2.6.5 below for more
information on reporting over target baselines (Formal Reprogramming).)
2.2.5.2 Variance Adjustment. In a formal reprogramming (over target
baseline), the contractor may: (1) apply the additional budget to completed
work, thereby eliminating some or all of the existing cost or schedulevariances, (2) apply the additional budget to remaining work, (3) apply someof the additional budget to completed work and some to remaining work, and/or(4) apply some of the additional budget to MR. If the contractor uses a
portion of the additional budget to eliminate variances applicable tocompleted work, the total adjustments made to the cost and schedule variances
shall be shown in Columns (10) and (11) of Block 9.a. The total cost varianceadjustment entered in Column (11) of Block 9.a should be the sum of theindividual cost variance adjustments shown in Column (12) of Block 8.g.
2.2.5.3 Total Contract Variance. In Columns (10) and (11) of Block 9.b,enter the sum of the cost and schedule variances shown on the Total line
(Block 8.g) and on the Variance Adjustment line (Block 9.a). In Column (14)enter the Contract Budget Base from Block 6.c.2. In Column (15) enter the
management EAC from Block 6.c.1. In Column (16) of Block 9.b enter thedifference between Columns (14) and (15) of Block 9.b.
2.2.6 Columns (2) Through (16). When compliance with the ANSI/EIA-748(current version in effect at time of contract award) is contractuallyrequired, the data in Columns (2) through (16) shall reflect the output of thecontractor's ANSI/EIA-748 compliant integrated management system.
2.2.6.1 Column (2) and Column (7) - Budgeted Cost - Work Scheduled. For thetime period indicated, enter the Budgeted Cost for Work Scheduled (BCWS) in
these columns.
2.2.6.2 Column (3) and Column (8) - Budgeted Cost - Work Performed. For thetime period indicated, enter the Budgeted Cost for Work Performed (BCWP) in
these columns.
2.2.6.3 Column (4) and Column (9) - Actual Cost - Work Performed. For thetime period indicated, enter the Actual Cost of Work Performed (ACWP) without
regard to ceiling. In all cases, costs and budgets shall be reported on acomparable basis.

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2.2.6.4 Column (5) and Column (10) - Variance – Schedule (i.e.,
accomplishment). For the time period indicated, these columns reflect thedifferences between BCWS and BCWP. For the current period column, Column (5)(schedule variance) is derived by subtracting Column (2) (BCWS) from Column(3) (BCWP). For the cumulative to date column, Column (10) (schedulevariance) is derived by subtracting Column (7) (BCWS) from Column (8) (BCWP).
A positive number in Column (5) and Column (10) indicates a favorable
variance. A negative number (indicated by parentheses) indicates anunfavorable variance. Significant variances as specified in the contract
shall be fully explained in Format 5. If the contract does not specify
variance analysis thresholds, the contractor shall provide appropriate
variance analyses. (See 2.6.3 below.)
2.2.6.5 Column (6) and Column (11) - Variance - Cost. For the time period
indicated, these columns reflect the difference between BCWP and ACWP. For
the current period column, Column (6) (cost variance) is derived bysubtracting Column (4) (ACWP) from Column (3) (BCWP). For the cumulative todate column, Column (11) (cost variance) is derived by subtracting Column (9)(ACWP) from Column (8) (BCWP). A positive value indicates a favorable
variance. A negative value (indicated by parentheses) indicates anunfavorable variance. Significant variances as specified in the contract
shall be fully explained in Format 5. If the contract does not specify
variance analysis thresholds, the contractor shall provide appropriate
variance analyses. (See 2.6.3 below.)
2.2.6.6 Column (12a) and Column (12b) Reprogramming Adjustments - Cost
Variance and Schedule Variance. Formal reprogramming (over target baseline)
results in budget allocations in excess of the Contract Budget Base and, insome instances, adjustments to previously reported variances. If previously
reported variances are being adjusted, the adjustment applicable to eachreporting line item affected shall be entered in Column (12a) if for a costvariance and Column (12b) if for a schedule variance. The total of Column(12a) and Column (12b) should equal 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
amounts added to the budget for each reporting line item as the result of
formal reprogramming (over target baseline). The amounts shown shall consistof the sum of the budgets used to adjust cost variances (Column (12)) plus the
additional budget added to the CWBS element for remaining work. Enter theamount of budget added to MR in the space provided on the Management Reserveline (Block 8.f of Column (13)). The total of Column (13) should equal thebudget amount by which the Total Allocated Budget exceeds the Contract Budget
Base as shown in Block 5.g of Format 3. An explanation of the reprogramming
shall be provided in Format 5.
2.2.6.7.1 Formal Reprogramming Reporting. Columns (12) and (13) are intended
for use only in situations involving formal reprogramming (over target
baseline). Internal replanning actions within the Contract Budget Base do not
require entries in these columns. Where contractors are submitting CPR data
directly from automated systems, the addition of Columns (12) and (13) asshown may not be practical due to computer reprogramming problems or space
limitations. In such cases, the information shall be provided in Format 5.
Contractors shall not be required to abandon or modify existing automatedreporting systems to include Columns (12) and (13) if significant costs will
be associated with such change. Nor shall contractors be required to prepare
the report manually solely to include this information.

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2.2.6.7.2. Formal Reprogramming Timeliness. Formal reprogramming (overtarget baseline) can be a significant undertaking that may require more than amonth to implement. To preclude a disruption of management visibility caused
by a reporting hiatus, formal reprogramming shall be implemented
expeditiously. If a reporting hiatus is needed, the contractor and theGovernment shall agree on the date and duration of the hiatus before theformal reprogramming is initiated.
2.2.6.8 Column (14) - At Completion - Budgeted. Enter the budgeted cost atcompletion for the items listed in Column (1). This entry shall consist of
the sum of the original budgets plus or minus budget changes resulting fromcontract 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 estimated overrun/underrun for all
authorized work. If the subtotal (Block 8.e) does not agree with the most
likely management EAC (Block 6.c.1), the difference shall be explained inFormat 5. (See 2.2.2.3 above.)
2.2.6.10 Column (16) - At Completion - Variance. Enter the difference
between the Budgeted - At Completion (Column (14)) and the Estimated - At
Completion (Column (15)) by subtracting Column (15) from Column (14). A
negative value (indicated by parentheses) reflects an unfavorable variance.
Significant variances as specified in the contract shall be fully explained inFormat 5. If the contract does not specify variance analysis thresholds, thecontractor shall provide appropriate variance analyses. (See 2.6.3 below.)
2.3

Format 2 - Organizational Categories.

2.3.1

Performance Data.

2.3.1.1 Column (1) - Organizational Category. In Block 5.a list theorganizational categories that reflect the contractor's internal management
structure. This format shall be used to collect organizational cost
information at the total contract level for organizational elements rather
than for individual CWBS elements. This column shall also identify each major
subcontractor as defined in the contract. The individual subcontractor line
shall reconcile with the cost to the prime (includes subcontractor fee, MR,
UB, G&A, cost of money, etc.) or shall track directly with the subcontractor
submittal consistent with the company/program documented process for
subcontract integration. The process for subcontract integration shall be
explained in Format 5. This column shall also identify each major
subcontractor and each major vendor separately as an add item. (Note: The
separation of subcontractor efforts is for reporting purposes and not intended
to impact how contracts are managed.) Except for material included in the add
item for each major subcontractor or major vendor, the column shall also
identify material separately as an add item. The level of detail to bereported normally will be limited to the organizational level immediately
under the operating head of the facility. The contractor may report thisinformation according to its own internal management structure. If thecontractor is organized by product teams, this format may not be needed
because it may resemble Format 1.
2.3.1.2 Cost of Money. Enter in Columns (2) through (16) of Block 5.b the
Facilities Capital Cost of Money applicable to the contract.

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2.3.1.3 General and Administrative. Enter in Columns (2) through (16) of
Block 5.c the appropriate G&A costs. If G&A costs have not been included in
the CWBS costs reported in Block 5.a above, G&A shall be shown as an add entry
in Block 5.a. If G&A costs have been included in the CWBS costs reported in
Block 5.a above, G&A shall be shown as a non-add entry in Block 5.c with anappropriate notation to that effect. If a G&A classification is not used, noentry shall be made other than an appropriate notation to that effect. (See
2.2.4.3 above.)2.3.1.4 Undistributed Budget. Enter in Column (14) of Block 5.d the budget
applicable to contract effort that cannot be planned in sufficient detail tobe assigned to a responsible organizational area at the reporting level. The
amount shown on this format may exceed the amount shown as UB on Format 1 ifbudget is identified to a task at or below the CWBS reporting level but
organizational identification has not been made; or may be less than theamount on Format 1 where budgets have been assigned to organizations but not
to CWBS elements. Enter in Column (15) of Block 5.d the EAC for the scope ofwork represented by the UB in Column (14) of Block 5.d. Enter in Column (16)of Block 5.d the variance, if any, and fully explain 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 costs and budgets in Columns (2)through (16) of Blocks 5.a through 5.e. (See 2.2.4.5 above.)2.3.1.6 Management Reserve. In Column (14) of Block 5.f enter the amount ofbudget identified as MR. The Management Reserve entry should agree with theamounts shown in Formats 1 and 3. (See 2.2.4.6 above.)2.3.1.7 Total. Enter the sum of all direct, indirect, cost of money, and G&A
costs and budgets, UB, and MR (if applicable) in Columns (2) through (14) of
Block 5.g. The totals on this page should equal the Total line on Format 1.
The total of Column (14) should equal the Total Allocated Budget shown in
Block 5.f on Format 3.
2.3.2 Columns (2) Through (16). The instructions applicable to these columns
are the same as the instructions for corresponding columns on Format 1. (See
2.2.6 and 2.2.6.1 through 2.2.6.10 above.)
2.4

Format 3 - Baseline.

2.4.1

Contract Data.

2.4.1.1 Original Negotiated Cost. Enter in Block 5.a the dollar value(excluding fee or profit) negotiated in the original contract. For a costplus fixed fee, incentive, or award fee contract, enter the estimated cost
negotiated. For an incentive contract, enter the definitized contract target
cost.
2.4.1.2 Negotiated Contract Changes. Enter in Block 5.b the cumulative cost(excluding fee or profit) applicable to definitized contract changes that haveoccurred since the beginning of the contract.
2.4.1.3 Current Negotiated Cost. Enter in Block 5.c the sum of Blocks 5.aand 5.b. The amount shown should equal the current dollar value (excluding
fee or profit) on which contractual agreement has been reached 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 Estimated Cost of Authorized, Unpriced Work. Enter in Block 5.d theestimated cost (excluding fee or profit) for contract changes for whichauthorization has been received from the contracting officer, but for 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.

Contract Budget Base.

Enter in Block 5.e the sum of Blocks 5.c and2.4.1.6 Total Allocated Budget. Enter in Block 5.f the sum of all budgets
allocated to the performance of the contractual effort. The amount shownshall include all MR and UB. This amount should be the same as that shown on
the Total line in Column (14) on Format 1 (Block 8.g) and Format 2 (Block
5.g).
2.4.1.7 Difference. Enter in Block 5.g the difference between Blocks 5.e and5.f. In most cases, the amounts shown in Blocks 5.e and 5.f will beidentical. If the amount shown in Block 5.f exceeds that shown in Block 5.e,
it usually is an indication of a formal reprogramming (over target baseline).
The difference shall be explained in Format 5 at the time the negative value
appears and subsequently for any changes in the difference between Contract
Budget Base and the Total Allocated Budget.
2.4.1.8 Contract Start Date. Enter in Block 5.h the date the contractor was
authorized to start work on the contract, regardless of the date of contract
definitization. (Note: Long-lead procurement efforts authorized under priorcontracts are not to be considered.)
2.4.1.9 Contract Definitization Date.
contract was definitized.

Enter in Block 5.i the date the2.4.1.10 Planned Completion Date. Enter in Block 5.j the completion date towhich the budgets allocated in the PMB have been planned. This daterepresents the planned completion of all significant effort on the contract.
The cost associated with the schedule from which this date is taken is the
Total Allocated Budget (Block 5.f of Format 3).
2.4.1.10.1 Performance Measurement Schedule Inconsistent With Contractual
Schedule. In exceptional cases, the contractor may determine that theexisting contract schedule cannot be achieved and no longer represents areasonable basis for management control. With Government approval, thecontractor may rephase its performance measurement schedule to new dates thatexceed the contractual milestones, a condition known as "over target
schedule." These new dates are for performance measurement purposes only anddo not represent an agreement to modify the contract terms and conditions.
2.4.1.10.2 Over Target Schedule Agreement. The Government and the contractor
shall agree on the new performance measurement schedule prior to reporting itin the CPR. The contractor shall provide pertinent information in Format 5 on
any schedule milestones that are inconsistent with contractual milestones,
beginning the month the schedule is implemented and each month thereafter.
2.4.1.10.3 Indicators of a Performance Measurement Schedule Inconsistent With
the Contractual Schedule. Formal reprogramming or internal replanning may
result in performance measurement milestones that are inconsistent with thecontractual milestones (Over Target Schedule). A difference between theplanned completion date (Block 5.j) and the contract completion date (Block5.k) usually indicates that some or all of the performance measurement
milestones are inconsistent with the contractual milestones.

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2.4.1.11 Contract Completion Date. Enter in Block 5.k the contract scheduled
completion date in accordance with the latest contract modification. The costassociated with the schedule from which this date is taken is the Contract
Budget Base (Block 5.e of Format 3).
2.4.1.12 Estimated Completion Date. Enter in Block 5.l the contractor'slatest revised estimated completion date. This date represents the estimatedcompletion 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 (Beginning of Period).
Enter 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 this line
(e.g., for Columns (4) through (9)) are taken directly from the PMB (End of
Period) line on the previous report. For example, the number in Column (4) on
the PMB (End of Period) line from the last report becomes the number in Column(3) on the PMB (Beginning of Period) line on this report. The number inColumn (5) (End of Period) last report becomes Column (4) (Beginning of
Period) on this report, etc. (if each of the two columns covers the samelength of time).
2.4.2.2 Baseline Changes. In Block 6.b, list all significant baselinechanges that have occurred during the reporting period. This listing shall
include the contract changes and supplemental agreements authorized during thereporting period, allocations from MR and UB, and any significant rephasing ofbudgets. All significant authorized baseline changes shall be listed whether
priced or unpriced.
2.4.2.3 Performance Measurement Baseline (End of Period). Enter in Block 6.c
the time-phased PMB as it exists at the end of the reporting period. The
difference between this line and the PMB (Beginning of Period) represents theeffects of all significant changes, including the authorized changes,
allocations of MR made during the period, and changes to time phasing due tointernal replanning or formal reprogramming. The reasons for these changes
shall be explained in Format 5.
2.4.2.4 Management Reserve. 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). This 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
Period) line (Block 6.a), enter the cumulative BCWS as of the first day of thereporting period. This should be the same number reported as BCWS Cumulative To Date on the Total line (Column (7) of Block 8.g) of Format 1 ofthe previous CPR. On the PMB (End of Period) line (Block 6.c), enter the
cumulative BCWS as of the last day of the reporting period. This should be
the same number reported as BCWS - Cumulative to Date on the Total line
(Column (7) of Block 8.g) of Format 1 for this CPR.

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2.4.4 Column (3) - BCWS For Report Period. On the PMB (Beginning of Period)
line (Block 6.a), enter the BCWS planned for the reporting period. Thisshould be the number in Column (4) on the PMB (End of Period) line (Block 6.c)on the previous CPR.
2.4.5 Columns (4) Through (14). Enter the names of each month for thecontract period of performance in the headings of each of the Columns (4)through (9), and the names of the appropriate periods in the headings of eachof the Columns (10) through (14) of Block 6. Columns beyond (14) may be added
when necessary or desirable. In the PMB (Beginning of Period) line (Block6.a), enter the BCWS projection reported in Format 3 of the previous CPR as
PMB (End of Period) (Block 6.c). In the PMB (End of Period) line (Block 6.c)of this report, enter the projected BCWS by month for the next six months andfor periodic increments (monthly, quarterly, or annually) thereafter for theremainder of the contract. The time phasing of each item listed in Column (1)of Block 6.b need not be shown in Columns (4) through (14). It is useful toshow the time phasing of any baseline changes. (Note: For the purposes ofillustration, Sample Format 3 has Columns (4) through (14) for reporting BCWS.
The actual number of columns will vary from contract to contract.)
2.4.6 Column (15) - Undistributed Budget. On the PMB (Beginning of Period)
line (Block 6.a), enter the number from Column (15) on the PMB (End of Period)
line (Block 6.c) from the previous CPR. On the PMB (End of Period) line,
enter the UB shown in 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 the number from Column (16) on the PMB (End of Period) line
(Block 6.c) from the previous CPR. In the section where baseline changes that
occurred during the period are listed (Column (1) of Block 6.b), enter theamount of each of the changes listed. On the PMB (End of Period) line (Block6.c), enter the sum of the amounts in the preceding columns on this line. On
the Management Reserve line (Block 7), enter the amount of MR available at theend of the period. On the Total line (Block 8) enter the sum of the amounts
in this column on the PMB (End of Period) line and the Management Reserveline. (Note: This should equal the amount in Block 5.f on this format andalso the amount of the Total line in Column (14), Block 8.g, of Format 1.)
2.5

Format 4 - Staffing.

2.5.1 Performance Data. For those organizational categories shown in Column(1) of Block 5, equivalent months shall be indicated for the current reporting
period (Column (2)), cumulative through the current period (Column (3)),
forecast to completion (Columns (4) through (14)), and at completion (Column(15)). Direct equivalent months shall be shown for each organizational
category for the contract. An equivalent month is defined as the effort equal
to that of one person for one month. Values shall be reported in whole
numbers. (Note: Partial months, .5 and above, shall be rounded to 1; below.5 to 0.) When the Government and the contractor agree, staffing may bereported in equivalent days or hours.
2.5.1.1 Column (1) - Organizational Category. In Block 5, list theorganizational categories that reflect the contractor's internal management
structure. Format 4 categories may differ from those reported in Format 2.
If the Government needs different categories in Formats 2 and 4, the Format 4
categories shall be addressed during negotiations. (See f.4 above.)2.5.1.2 Total Direct. In Block 6, Columns (2) through (15), enter the sum of
all direct equivalent months for the organizational categories shown in Column
(1).

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2.5.2 Column (2) - Actual - Current Period. Enter the actual equivalentmonths incurred during the current reporting period.
2.5.3 Column (3) - Actual End of Current Period (Cumulative). Enter theactual equivalent months incurred to date (cumulative) as of the end of thereporting period.
2.5.4 Columns (4) Through (14) - Forecast (Non-Cumulative). Enter the namesof each month for the contract period of performance in the headings of eachof the Columns (4) through (9), and the names of the appropriate periods inthe headings of each of the Columns (10) through (14) of Block 5. Enter astaffing forecast by month for the next six months and for periodic increments(monthly, quarterly, or annually) thereafter for the remainder of thecontract. The staffing forecast shall be updated as part of the formal EAC
process followed by the contractor. The staffing forecast shall reflect thesame staffing estimate used as the basis for the EAC in Column (15) on both
Format 1 and Format 2. (Note: For the purposes of illustration, Sample
Format 4 has Columns (4) through (14) for reporting staffing forecast. The
actual number of columns will vary from contract to contract.)
2.5.5 Column (15) - Forecast at Completion. Enter the estimate of equivalentmonths necessary for the total contract in Column (15) by organizational
category. This estimate shall be consistent with the “most likely” management
EAC shown in Column (15) of Block 8.e of Format 1. Any significant change inthe total number of equivalent months at completion of the contract (i.e.,
Column (15) Total) shall be explained in Format 5.
2.6

Format 5 - Explanations and Problem Analyses.

2.6.1 General. Format 5, Explanations and Problem Analyses, is a narrative
report prepared to amplify and explain data in the other CPR formats. Format
5 shall normally address the following: (1) contractually required cost,schedule, and EAC variance analyses, (2) MR changes and usage, (3) UB
contents, (4) differences between the best case, worst case, and most likely
management EAC, if any, (5) the difference between the most likely management
EAC and the estimate in Block 8.e of Column (15), if any, (6) significant
differences between beginning of period PMB time phasing and end of period PMBtime phasing in Format 3, (7) performance measurement milestones that areinconsistent with contractual milestones (Over Target Schedule), (8) formal
reprogramming (over target baseline) implementation details, and (9)significant staffing estimate changes in Format 4. Any other topic relevant
to contract cost, schedule, or technical performance may be addressed in thisformat. The date(s) of the Integrated Baseline Review(s) may also be
addressed in this format. Contractors may elect to attach subcontractor
Format 5 reporting and cross reference this analysis in the Format 5 reporting
submitted to the Government to gain time efficiencies and meet submission
dates.
2.6.2 Total Contract. Provide a summary analysis that identifies significant
problems affecting performance. Indicate corrective actions required,including Government action where applicable. Significant changes since theprevious report shall be highlighted. Discuss any other issues affecting
successful attainment of contract cost, schedule, or technical objectives thatthe contractor deems significant or noteworthy. This section is brief,
normally one page.
2.6.3 Cost and Schedule Variances. Explain all variances that exceed
specified variance thresholds. Explanations of variances shall clearly

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identify the nature of the problem, significant reasons for cost or schedulevariance, effect on the immediate task, impact on the total contract, and thecorrective action taken or planned. Explanations of cost variances shallidentify amounts attributable to rate changes separately from amounts
applicable to hours worked; amounts attributable to material price changes
separately from amounts applicable to material usage; and amounts attributable
to overhead rate changes separately from amounts applicable to overhead basechanges or changes in the overhead allocation basis. To reduce the volume ofvariance analysis explanations, the contractor may refer to a prior CPR'svariance analysis explanations if the explanation for the current CPR'svariance has not changed significantly. Explanations of schedule variances
and the impact on the contract shall be performed in parallel with theschedule analysis called out by the IMS DID. Accordingly, there is arequirement in b. above for the IMS DID, DI-MGMT-81650, 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 Format 5, the Government
will require only that amount of variance analysis that satisfies its
management information needs. Excessive variance analysis is burdensome andcostly, and detracts from the CPR's usefulness, while too little information
is equally undesirable.
2.6.4 Other Analyses. In addition to variance explanations, the following
analyses are mandatory:
2.6.4.1. Management Estimate at Completion. If the best or worst casemanagement EACs differ from the most likely estimate (Column (1) of Block 6 ofFormat 1), a brief explanation of the difference shall be provided. Also, if
the most likely management EAC differs from the total entered in Column (15)of Format 1 or 2, the difference shall be explained. The explanations shallfocus on such areas as a knowledgeable, realistic risk assessment; projected
use of MR; estimate for UB; and higher management’s knowledge of current or
future contract conditions. The assumptions, conditions, 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 Undistributed Budget. Identify the effort to which the UB applies.
Also, explain any variance between the UB and the 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. Identify the sources and uses of MRchanges during the reporting period. Identify the CWBS and organizational
elements to which MR is applied, and the reasons for its application. (See
2.2.4.6 above.)
2.6.4.4 Baseline Changes. Explain reasons for significant shifts in timephasing of the PMB shown on Format 3. (See 2.4.2.3 above.)
2.6.4.5 Staffing Level Changes. Explain significant changes in the total
staffing EAC shown on Format 4. Also, explain reasons for significant shifts
in time phasing of planned staffing. (See 2.5.5 above.)
2.6.5 Formal Reprogramming (Over Target Baseline). If the difference shownin Block 5.g on Format 3 becomes a negative value or changes in value, provide
information on the following:
2.6.5.1 Authorization. Procuring activity authorization for the baselinechange that resulted in negative value or change.

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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(i.e., amount allocated to MR, adjustments to cost or schedule variances,etc.). (See 2.4.1.7, 2.2.5.1, and 2.2.6.7 above.)
2.6.5.4 Schedule. Indicate whether the contract schedule was retained for
performance measurement or was replaced with a schedule that exceeds thecontractual schedule (Over Target Schedule).
2.6.6 Over Target Schedule. If a performance measurement schedule exceeding
the contractual schedule (Over Target Schedule) has been implemented, provide
a discussion of the pertinent information, such as authorization, reasons, andsignificant dates. (See 2.4.1.10.1 above.)
END OF DI-MGMT-81466A

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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, Schedule 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 Performed _______ 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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OVERVIEW
Earned Value Management (EVM) is a program management tool, technique, 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 qualities and characteristics of an EVM system are set forth in theAmerican National Standards Institute/Electronic Industries Alliance (ANSI/EIA) Standard-748(most current version). More detailed and specific guidance and direction is contained in OMBCircular A-11, Preparation, Submission and Execution of the Budget, specifically in Part 7 ofthat Circular A-11, Planning, Budgeting, Acquisition, and Management of Capital Assets, and its
supplement, the Capital Programming Guide. Based on this collective OMB guidance, EVMS isintended to be used on those parts of acquisitions that will involve developmental effort. This
would include not only those acquisitions designated by the agency as major systems but also
those acquisitions that include significant developmental, modification, or upgrade during theoperational or steady-state phase of a program.
The FAR rule on EVMS became effective on July 5, 2006. Its purpose is to implement EVMS
policy in accordance with OMB 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 Acquisition Regulations (HHSAR) language for
EVMS will be utilized for all construction or Information Technology (IT) projects. Since mostof the acquisitions at the Biomedical Advanced Research 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 Management. 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 OMB.
The Seven Principles of Earned Value Management 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. Control
changes to the baseline.
4. Use actual costs incurred and recorded in accomplishing the work performed.

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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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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/EIA-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 (NDIA) Program
Management Systems Committee (PMSC) ANSI/EIA-748 Standard for Earned ValueManagement Systems Intent Guide should be used as guidance.
TIER 2For 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.
TIER 3For 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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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 Principles 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 scheduling will be required on a 7 Principles Tier 2
implementation. These normal functions include, network scheduling, 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 milestones 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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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 principle 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 indirect 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 should only stay in Undistributed Budget for one or 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 valid 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 should 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 should 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, WBS (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
accomplishments or obtain what we call “earned value”. These units or milestones are given a
value based on labor resources needed to accomplish the work (which becomes the Budgeted
Cost of Work Scheduled or BCWS). When they are accomplished (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 0/100
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 system should also provide both monthly 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 ascertained 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 actions 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 following appendices provide further support in understanding the meaning and intent ofproperly implementing the 7 Principles of EVM.
Appendix 1 is a glossary of the terms used in the Intent Guide.
Appendix 2 is supplemental guidance on EVM implementation. It provides some guidelines onwhat 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)The 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 facility.

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 Implementation 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 to14129

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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 IBR 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(IMS)

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.

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 given 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 estimated 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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7 Principles of EVM Tier 2 System Implementation Intent Guideof work.

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 (OTB).

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 efficiency 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 current cost estimatesand budget and to indicate when a comprehensive EAC
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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 distinguishable 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 objective 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 ($50K - $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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to maintain baseline, actual costs, forecast and performance periodic data. It should be able toforecast Estimate to Complete with the ability 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 facilitation 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 Tier 3 contract. The
costs for a schedule analyst on 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 ANSI/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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COST OF EVM
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 development 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 of EVM 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”.

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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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Subcontractors
VendorArea of Responsibility

Phase Researcho Study Documentation Design and Developmento Clinical Monitoring: Includes site initiation, interim, and close-out
monitoring visits,o Pharmacovigilenceo Data Management: Includes build and maintenance of electronic case
o
o
o

o

report 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
Travel for CRA monitoring visits to clinical sites, shipping andprinting costso Investigator Grants
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 oversightRolf Xerd

Pharmacologist:
Design and analysis consultation for PK parameters and analysis

Julie Simms

Clinical Trials Manager

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Phil Thomas

Medical Writer

Claire Cools

SAS Programmer

Mary Doe

Clinical Contracts

Jim Dodds

Supply Chain Manager

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 follow-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

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Sample Control Account Plan

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HHS0100201600031C

Attachment 11
Listing of Project-Relevant Background Inventions(b) (4)(b)(4)

Attachment 12
Data Rights Assertion Table
Data Rights Assertion Table
Identification and Assertion of Restrictions on the Government's Use, Release, or Disclosure ofTechnical Data or Computer Software.
The Contractor asserts for itself, or the persons identified below, that the Government's rights to use,release, or disclose the following technical data or computer software should be restricted:
Technical data or computer
software to be furnishedwith restrictions*(LIST)*****(b) (4)

Basis for assertion**

Asserted rights
category***(LIST)(LIST)Name of person
assertingrestrictions****(LIST)

(b) (4)*For technical data (other than computer software documentation) pertaining to items, components, or processes developed at private expense,
identify both the deliverable technical data and each such item, component, or process. For computer software or computer software documentation
identify the software or documentation.
**Generally, development at private expense, either exclusively or partially, is the only basis for asserting restrictions. For technical data, other thancomputer software documentation, development refers to development of the item, component, or process to which the data pertain. The
Government's rights in computer software documentation generally may not be restricted. For computer software, development refers to thesoftware. Indicate whether development was accomplished exclusively or partially at private expense. If development was not accomplished at private
expense, or for computer software documentation, enter the specific basis for asserting restrictions.
***Enter asserted rights category (e.g., government purpose license rights from a prior contract, rights in SBIR data generated under another contract,
limited, restricted, or government purpose rights under this or a prior contract, or specially negotiated licenses).

****Corporation, individual, or other person, as appropriate.
*****Enter “none” when all data or software will be submitted without restrictions.