Exhibit 10.1

*** Text Omitted and Filed Separately
Confidential Treatment Requested
Under 17 C.F.R. §§ 200.80(b)(4)
and 240.24b-2
OMB Approval 0990-0115
 

  
1.THIS CONTRACT IS A RATED ORDER
RATING
PAGE   OF   PAGES
AWARD/CONTRACT
UNDER DPAS (15 CFR 350)
Ø
N/A
1
43

2.  CONTRACT (Proc. Inst. Ident.) NO.
3.  EFFECTIVE DATE
4.  REQUISITION/PURCHASE REQUEST/PROJECT NO.
HHSO100201100007C
See block 20C (below)
 OS54272

5.  ISSUED BY
CODE 
 
6.  ADMINISTERED BY (If other than Item 6)
CODE 
 

Office of Acquisitions Management, Contracts, and Grants (AMCG)
330 Independence Ave., S.W. Room G640
Washington, D.C. 20201
See Block 5.

7.  NAME AND ADDRESS OF CONTRACTOR (No. street, county, state and ZIP Code)
8.  DELIVERY
Aeolus Pharmaceuticals
26361 Crown Valley Parkway
See Schedule.
Suite 150
9/ DISCOUNT FOR PROMPT PAYMENT
Mission Viejo, CA 92691
N/A
   
CAGE: 4ZR28
10. SUBMIT INVOICES
ITEM
CODE DUNS No. 883671885
FACILITY CODE
ADDRESS SHOWN IN:
See Section G.

11.  SHIP TO/MARK FOR
CODE
N/A
12.  PAYMENT WILL BE MADE BY
CODE 
N/A
See Block 5
See Block 5
13.  AUTHORITY FOR USING OTHER FULL AND OPEN COMPETITION:    N/A
14.  ACCOUNTING AND APPROPRIATION DATA
o 10 U.S.C. 2304(c)(     )
o 41 U.S.C. 253(c)(     )
CAN# - 1992002

15A. ITEM NO.
15B.  SUPPLIES/SERVICES
  15C. UNIT PRICE
  15D.  AMOUNT
  15E.  UNIT PRICE
  15F.  AMOUNT
Title: Advanced Development of AEOL 10150 as a Medical
CLIN 0001
$
10,399,717
 CLIN 0009
$
5,731,452
Countermeasure for Pulmonary Injury Associated with ARS and DEARE
CLIN 0002
$
1,133,912
 CLIN 0010
$
1,729,416
Period:  February 11, 2011  through February 10, 2012
CLIN 0003
$
9,358,035
 CLIN 0011
$
16,173,991
Contract Type:  Cost Plus Fixed Fee
CLIN 0004
$
6,063,848
 CLIN 0012
$
18,235,505
BAA BARDA 09-34
CLIN 0005
$
5,487,641
 CLIN 0013
$
7,228,652
 
CLIN 0006
$
889,327
 CLIN 0014
$
12,368,213
  
CLIN 0007
$
3,185,520
 CLIN 0015
$
14,501,680
    
CLIN 0008
$
4,181,861
 CLIN 0016
$
1,691,774

 5G.  TOTAL AMOUNT OF CONTRACT             Ø     
$
10,399,717
16.  TABLE OF CONTENTS

(ü)
SEC.
DESCRIPTION
PAGE(S)
(ü)
SEC.
DESCRIPTION
PAGE(S)
PART I - THE SCHEDULE
PART II - CONTRACT CLAUSES
x
A
SOLICITATION/CONTRACT FORM
1
x
I
CONTRACT CLAUSES
37
x
B
SUPPLIES OR SERVICES AND PRICE/COST
3
PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.
x
C
DESCRIPTION / SPECS / WORK STATEMENT
9
x
J
LIST OF ATTACHMENTS
42
x
D
PACKAGING AND MARKING
20
PART IV - REPRESENTATIONS AND INSTRUCTIONS
x
E
INSPECTION AND ACCEPTANCE
20
x
K
REPRESENTATIONS, CERTIFICATIONS
43
x
F
DELIVERIES OR PERFORMANCE
21
   
AND OTHER STATEMENTS OF OFFERORS
 
x
G
CONTRACT ADMINISTRATION DATA
25
o
L
INSTRS., CONDS., AND NOTICES TO OFFERORS
 
x
H
SPECIAL CONTRACT REQUIREMENTS
29
o
M
EVALUATION FACTORS FOR AWARD
 
CONTRACTING OFFICER WILL COMPLETE ITEM 17 OR 18 AS APPLICABLE

17.  x CONTRACTOR’S NEGOTIATED AGREEMENT (Contractor is required to sign this
document and return _2_ copies to issuing office.)  Contractor agrees to furnish
and deliver all items or perform all the services set forth or otherwise
identified above and on any continuation sheets for the consideration stated
herein.  The rights and obligations of the parties to this contract shall be
subject to and governed by the following documents:  (a) this award/contract,
(b) the solicitation, if any, and (c) such provisions, representations,
certifications, and specifications, as are attached or incorporated by reference
herein.  (Attachments are listed herein.)
18. o  AWARD (Contractor is not required to sign this document.)  Your offer on
Solicitation Number _______________________________________, including the
additions or changes made by you which additions or changes are set forth in
full above, is hereby accepted as to the items listed above and on any
continuation sheets.  This award consummates the contract which consists of the
following documents:  (a) the Government’s solicitation and your offer, and (b)
this award/contract.  No further contractual document is necessary.
19A.  NAME AND TITLE OF SIGNER   (Type or print)
20A.  NAME OF CONTRACTING OFFICER
John McManus, CEO
[…***…]
   

19B.  NAME OF CONTRACTOR
 19C.  DATE SIGNED     
20B.  UNITED STATES OF AMERICA
 20C.  DATE SIGNED     
       
/s/ John McManus
 
BY  
[…***…]
 
(Signature of person authorized to sign)
   
(Signature of Contracting Officer)
 

NSN 7540-01-152-8069
26-107
STANDARD FORM 26 (REV. 4-85)
PREVIOUS EDITION UNUSABLE
Computer Generated
Prescribed by GSAFAR (48 CFR) 53.214(a)

 
*Confidential Treatment Requested
 
 
 

--------------------------------------------------------------------------------

 
 

CONTRACT TABLE OF CONTENTS

PART I – THE SCHEDULE
3
SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS
3
SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT
9
SECTION D - PACKAGING, MARKING AND SHIPPING
20
SECTION E - INSPECTION AND ACCEPTANCE
20
SECTION F - DELIVERIES OR PERFORMANCE
21
SECTION G - CONTRACT ADMINISTRATION DATA
24
SECTION H - SPECIAL CONTRACT REQUIREMENTS
27
PART II – CONTRACT CLAUSES
35
SECTION I - CONTRACT CLAUSES
35
PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS
40
SECTION J - LIST OF ATTACHMENTS
40
PART IV - REPRESENTATIONS AND INSTRUCTIONS
41
SECTION K - REPRESENTATIONS AND CERTIFICATIONS
41

 
2

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PART I – THE SCHEDULE
 
SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS
 
ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES
 
This contract is for the development of AEOL 10150 as a MCM against ARS/DEARE
pulmonary effects via the FDA’s “Animal Rule” (See 21 CFR 314.600§I). This
development pathway requires demonstration of the key study efficacy parameter
of AEOL 10150 treatment in two animal models relevant to the human radiation
response and its treatment, demonstration of safety in humans, demonstration of
relevant dosing and administration in humans, and clear identification of the
mechanism of radiation-induced damage to the lung and its amelioration by the
candidate drug.

The research and development (R&D) effort will progress in specific stages that
cover the base year performance segment and each of the fifteen (15) option
segments specified in this contract.  Work performed during the base segment and
during each of the option segments is considered to constitute a non-severable
discrete work segment that is necessary for the R&D effort related to the
vaccine.  The Contractor must complete specific tasks required in each discrete
work segment before the Government will exercise any of the follow-on option
segments.  Exercise of the follow-on options is solely at the discretion of the
government.   The contractor’s success in completing the required tasks under
each work segment must be demonstrated through the Technical Deliverables
specified under Article F.2 (WBS Milestone Deliverables and Technical
Deliverables) and the deliverables listed on Attachment 6 to this contract.
Those deliverables will support GO/NO GO decisions specified on Attachment
6.  The GO/NO GO criteria will constitute the basis for the government’s
decision, at its sole discretion, to exercise any follow-on option segment.

Work under this contract will proceed for a maximum of five (5) years.  The base
and option segments under Contract Line Items (”CLINs”) 0001 through 0016 are
event driven work segments rather than time driven CLINs. The periods of
performance listed under each of the CLINs under Article B.2 below are estimated
time periods.  Those individual time periods may be extended as needed, at the
government’s discretion, to complete the tasks required under each work
segment.  However the completion of the final tasks required under CLIN 0016 and
option segment number fifteen must be completed no later than five (5) years
after initial award of this contract.

ARTICLE B.2. ESTIMATED COST AND FIXED FEE
 
a.
The total estimated cost of the base period of performance contract is $
9,993,778.

 
b.
The total fixed fee for the base period of performance contract is $ 405,939.

 
c.
The fixed fee shall be paid as a percentage of costs incurred on any given
month, subject to Allowable Cost and Payment and Fixed Fee Clauses. Payment of
fixed fee shall not be made in less than monthly increments.

 
d.
The total amount of the base performance segment, CLIN 0001, represented by the
sum of the total estimated cost plus fixed fee is $ 10,399,717.

 
e.
It is estimated that the amount currently allotted will cover performance of the
contract through 2/10/2011.

 
3

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CLIN
 
Estimated
Period of
Performance
 
Supplies/Services
 
Quantity
(Units)
 
Total
Estimated
Cost
   
Fixed Fee
   
Total Estimated
Cost Plus
Fixed Fee
 
0001
 
2/11/2011 – 2/10/2012
 
Advanced Development of AEOL 10150 as a Medical Countermeasure for Pulmonary
Injury Associated with ARS and DEARE
 
Reports and Other Data Deliverables
 
1 Job
  $ 9,993,778     $ 405,939     $ 10,399,717  

 
ARTICLE B. 3. OPTION PRICES
 
 
a.
Unless the government exercises its option pursuant to the option clause
contained in ARTICLE I, the contract consists only of the Base Work Segment
specified in the Statement of Work as defined in SECTONS C and F, 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 contact modification, require the Contractor to
perform the Option Period(s) specified in the Statement of Work as defined in
SECTIONS C and F of this contract. If the Government exercises the/these
option(s), notice will be provided per the time frames specified under Article
H.17 and FAR Clause 52.217-9 in Article I.4. Specific information regarding the
time frame for this notice is set forth in the OPTION CLAUSE Article in SECTION
G of this contract. The estimated cost of the contract will be increased as set
forth below:

 
OPTIONS
 
Option 1 (CLIN 0002)
Option 2 (CLIN 0003)
Option 3 (CLIN 0004)
Option 4 (CLIN 0005)
Option 5 (CLIN 0006)
Option 6 (CLIN 0007)
Option 7 (CLIN 0008)
Option 8 (CLIN 0009)
Option 9 (CLIN 0010)
Option 10 (CLIN 0011)
Option 11 (CLIN 0012)
Option 12 (CLIN 0013)
Option 13 (CLIN 0014)
Option 14 (CLIN 0015)
Option 15 (CLIN 0016)

 
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CLIN
 
Option
Period
 
Supplies/Services
 
Quantity
(Units)
 
Cost
   
Fixed Fee
   
Estimated
Cost
 
0002
 
12/12/11 – 2/10/16
 
Stability Studies
 
1 Job
  $ 1,090,300     $ 43,612     $ 1,133,912  
0003
 
2/11/12 – 7/27/13
 
Animal Efficacy & Initial GMP Production
 
1 Job
  $ 8,993,018     $ 365,035     $ 9,358,053  
0004
 
2/11/12 – 7/27/13
 
Safety and CMC
 
1 Job
  $ 5,829,473     $ 234,375     $ 6,063,848  
0005
 
2/11/12 – 2/10/14
 
 
NHP Radiation Dose Evaluation – PBI BM5
 
 
1 Job
  $ 5,276,142     $ 211,499     $ 5,487,641  
0006
 
2/16/12 – 10/2/12
 
Murine Extended Natural History
 
1 Job
  $ 854,686     $ 34,641     $ 889,327  
0007
 
2/29/12 – 7/9/13
 
Mutagenicity/Teratogenicity
 
1 Job
  $ 3,063,000     $ 122,520     $ 3,185,520  
0008
 
12/1/12 – 6/30/14
 
 
NHP AEOL 10150 Delayed Treatment Study
 
1 Job
  $ 4,020,584     $ 161,277     $ 4,181,861  
0009
 
2/11/13 – 3/31/14
 
NHP Extended Natural History - WTLI
 
1 Job
  $ 5,510,575     $ 220,876     $ 5,731,452  
0010
 
6/13/13 – 1/27/16
 
Fourth Registrational Batch
 
1 Job
  $ 1,662,900     $ 66,516     $ 1,729,416  
0011
 
7/28/13 – 7/27/15
 
NHP Pivotal Efficacy Study – WTLI
 
1 Job
  $ 15,544,099     $ 629,892     $ 16,173,991  
0012
 
11/11/13 – 7/27/15
 
Manufacturing Scale Up
 
1 Job
  $ 17,532,560     $ 702,945     $ 18,235,505  
0013
 
7/28/13 – 7/27/15
 
Pivotal Safety Study
 
1 Job
  $ 6,949,048     $ 279,604     $ 7,228,652  
0014
 
7/28/13 – 7/27/15
 
NHP Pivotal Efficacy Study PBI BM5
 
1 Job
  $ 11,892,512     $ 475,7000     $ 12,368,213  
0015
 
7/28/13 – 7/27/15
 
Long Term Pivotal Safety Study
 
1 Job
  $ 13,943,923     $ 557,757     $ 14,501,680  
0016
 
6/10/15 – 2/10/16
 
NDA Preparation and Filing
 
1 Job
  $ 1,623,904     $ 67,870     $ 1,691,774  

ARTICLE B. 4. PROVISIONS APPLICABLE TO DIRECT COSTS

a.      Items Unallowable Unless Otherwise Provided

Notwithstanding the clauses, ALLOWABLE COST AND PAYMENT, and FIXED FEE,
incorporated in this contract, unless authorized in writing by the Contracting
Officer, the costs 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.      Purchase or lease of any item of general purpose office furniture or
office equipment regardless of dollar values. (General purpose equipment is
defined as any items of personal property which are usable for purposes other
than research, such as office equipment and furnishings, pocket calculators,
etc.);

4.      Travel to attend general scientific meetings;

5.      Unapproved foreign travel – Subject to the procedure specified under
subparagraph b.2 below;

6.      Consultant costs;

7.      Subcontracts;

8.      Patient care costs;

 
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9.      Accountable Government property (defined as both real and personal
property with an acquisition cost of $1,000 or more and a life expectancy of
more than two years) and “sensitive items” (defined and listed in the
Contractor’s Guide for Control of Government Property), regardless of
acquisition value.

10.    Printing Costs (as defined in the Government Printing and Binding
Regulations).

11.    Light Refreshment and Meal Expenditures

Requests to use contract funds to provide light refreshments and/or meals to
either federal or nonfederal employees must be submitted to the Contracting
Officer’s Technical Representative (COTR), with a copy to the Contracting
Officer, at least six (6) weeks in advance of the event. 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 provide; (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 number of nonfederal and federal
attendees receiving light refreshments and/or meals; and (e) if the event will
be held at a government facility.
 
b.     Travel Costs
 
1.    Domestic Travel

a.      Total expenditures for domestic travel (transportation, lodging,
subsistence, and incidental expenses) incurred in direct performance of this
contract shall not exceed $12,740 in the base 12 month period without the prior
written approval of the Contracting Officer.

b.      Subject to the CLIN 0001 dollar limitation specified under B.4.b.1.a.
above, the Contactor shall invoice and be reimbursed for all travel costs in
accordance with Federal Acquisition Regulations (FAR) 31.2 – Contracts with
Commercial Organizations, Subsection 31.205-46, Travel Costs.

2.    Foreign Travel

a.      Total expenditures for foreign travel (transportation, lodging,
subsistence, and incidental expenses) incurred in direct performance of this
contract shall not exceed $0 in CLIN 0001 without the prior written approval of
the Contracting Officer.

b.      Requests for foreign travel must be submitted at least six weeks in
advance and shall contain the following: (a) meeting(s) and place(s) to be
visited, with costs and dates; (b) names(s) and title(s) of Contractor personnel
to travel and their functions in the contract project; (c) contract purpose to
be served by the travel; (d) how travel of Contractor personnel will benefit and
contribute to accomplishing the contract project, or will otherwise justify the
expenditure of AMCG 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
to accomplish other purposed of the contact and thus further benefit the
project.

ARTICLE B.5. ADVANCE UNDERSTANDINGS

a.      Security Plan – RESERVED

b.      The Contractor agrees to provide data generated from this contact to the
Contracting Officer upon request either in the form of an email attachment or
via delivery to a secured Government eRoom.

 
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c.    Subcontracts and Consultants
 
Reference 52.244-2(d) & (e) Subcontracts.
 
The Contractor shall obtain the Contracting Officer’s written consent (COA)
prior to placing any cost reimbursement subcontract or any firm fixed price
subcontract in excess of $100,000.
FAR 52.244-2 (e)(1) The Contractor shall notify the Contracting Officer
reasonably in advance of placing any subcontract or modification thereof for
which consent is required under paragraph (d) of this clause, including the
following information:
(i).         A description of the supplies or services to be subcontracted.
(ii).        Identification of the type of subcontract to be used.
(iii).       Identification of the proposed subcontractor.
(iv).       The proposed subcontract price.
(v).        The subcontractor’s current, complete, and accurate cost or pricing
data and Certificate of Current Cost or Pricing Data, if required by other
contract provisions.
(vi).       The subcontractor’s Disclosure Statement or Certificate relating to
Cost Accounting standards when such data are required by other provisions of
this contract.
(vii).      A negotiation memorandum reflecting-
(A). The principal elements of the subcontract price negotiations;
(B). The most significant considerations controlling establishment of initial or
revised prices;
(C). The reason cost or pricing data were or were not required;
(D). The extent, if any, to which the Contractor did not rely on the
subcontractor’s cost or pricing data in determining the price objective an in
negotiating the final price;
(E). The extent to which it was recognized in the negotiation that the
subcontractor’s cost or pricing data were not accurate, complete, or current;
the action taken by the Contractor and the subcontractor; and  the effect of any
such defective data on the total price negotiated;
(F). The reasons for any significant difference between the Contractor’s price
objective and the price negotiated; and
(G). A complete explanation of the incentive fee or profit plan when incentives
are used. The explanation shall identify each critical performance element,
management decisions used to quantify each incentive element, reasons for the
incentives, and a summary of all trade-off possibilities considered.

The Contractor shall obtain the Contracting Officer’s written consent (COA)
prior to placing any consultant awards.

d.     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:

1.      Direct Labor - List individuals by name, title/position, hourly/annual
rate, level of effort, and amount claimed.
2.      Travel - Identify travelers, dates, destination, purpose of trip, and
amount. Cite COA, if appropriate. List separately, domestic travel, general
scientific meeting travel, and foreign travel.
3.      Consultant Fees - Identify individuals and amounts.
4.      Subcontracts - Attach subcontractor invoice(s).
5.      Indirect Overhead
6.      Total Cost
7.      Fixed Fee
8.      Total CPFF

 
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Monthly invoices must include the cumulative total expenses to date, adjusted
(as applicable) to show any amounts suspended by the Government.

e.      Confidential Treatment of Sensitive Information

The Contractor shall guarantee strict confidentiality of the information/data
that it is provided by the Government during the performance of the contract.
The Government has determined that the information/data that the Contractor will
be provided during the performance of the contract is of a sensitive nature.

Disclosure of the information/data, 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 with regard to the
proper handling of information/data under the contract, the Contractor shall
obtain a written determination from the Contracting Officer.
 
f.      Site Visits and Inspections

At the discretion of the USG and independent of activities conducted the
Contractor, with 10 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 and intermediates held by the contractor, or subcontractor.
In case of subcontractor visits and inspections that are independent of
activities conducted by the Contractor, the USG shall demonstrate cause for such
visit and/or inspection. These visits shall be coordinated through the Prime
Contractor. 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, and cGMP/GLP/GCP compliance

g.      Indirect rate

A one rate system was agreed upon, with an indirect rate of 80% applied to a
modified direct cost base that excludes subcontracts. No ceiling shall be
applied to this rate. Annual incurred cost submissions must be sent to the
Contracting Officer within 6 months following the fiscal year, and annual audits
and development of the final rates will be determined by HHS auditors.

h.      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 with USG entities
responsible for Medical Countermeasure Development.  In accordance with
recommendations from the Public Health Emergency Medical Countermeasure
Enterprise Review, agreements established in the Integrated Portfolio’s
Portfolio Advisory Committee (PAC) Charter, Technology Transfer Agreements (TTA)
between BARDA and the Defense Threat Reduction Agency and the National Institute
of Allergies and Infectious Diseases (NIAID), BARDA may share technical
deliverables set forth in Article F.2 with colleagues within the Integrated
Portfolio.  This advance understanding does not authorize BARDA to share
financial information outside HHS.  The Contractor is advised to review the
terms of FAR Clause 52.227-14 regarding the Government’s rights to deliverables
submitted during performance as well as the Government’s rights to data
contained within those deliverables.

 
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SECTION C· DESCRIPTION/SPECIFICATIONS/WORK STATEMENT
 
ARTICLE 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 not otherwise provided by the Government as needed to perform the
Statement of Work dated 11/17/2010 set forth in SECTION J - List of Attachments,
attached hereto and made a part of the contract.
 
ARTICLE C.2. REPORTING REQUIREMENTS
 
Technical Reports
In addition to those reports required by the other terms of this contract, the
Contractor shall prepare and submit the following reports in the manner stated
below and in accordance with the DELIVERIES Article in SECTION F of this
contract.

A.      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 on or before the 15th
calendar day following the last day of each reporting period and shall include
the following:
A cover page that includes the contract number and title; the type of report and
period that it covers; the Contractor's name, address, telephone number, fax
number, and e-mail address; and the date of submission;
SECTION I-An introduction covering the purpose and scope of the contract effort;
SECTION II-PROGRESS
SECTION II Part A: OVERALL PROGRESS-A description of overall progress;
SECTION II Part B: MANAGEMENT AND ADMINISTRATIVE UPDATE-A description of all
meetings, conference calls, etc. that have taken place during the reporting
period. Include progress on administration and management issues (e.g.
evaluating, and managing subcontractor performance);
SECTION II Part C: TECHNICAL PROGRESS-For each activity, document the results of
work completed and cost 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 to explain any significant
results achieved and preliminary conclusions resulting from analysis and
scientific evaluation of data accumulated to date under the contract. The report
shall include a description of problems encountered and proposed corrective
action; differences between planned and actual progress, why the differences
have occurred and what corrective actions are planned; preliminary conclusions
resulting from analysis and scientific evaluation of data accumulated to date
under the project;
SECTION II Part D; PROPOSED WORK-A summary of work proposed for the next
reporting period and preprints/reprints of papers and abstracts.
A Monthly Progress Report will not be required in the same month that the Annual
Technical
Progress Report is submitted.

B. Quarterly 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 quarter of performance plus any
fractional part of the initial quarter. Thereafter, the reporting period shall
consist of each calendar quarter.

 
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The Contractor shall submit a Quarterly Progress Report on or before the 15th
calendar day following the last day of each reporting period and shall include
the following:
A cover page that includes the contract number and title; the type of report and
period that it covers; the Contractor’s name, address, telephone number, fax
number, and e-mail address; and the date of submission;
SECTION I-An introduction covering the purpose and scope of the contract effort.
The progress report shall include a Table of Contents and Executive summary in
accordance with the DELIVERIES Article in SECTION F of this contract.
SECTION II-PROGRESS
SECTION II Part A: OVERALL PROGRESS-A description of overall progress;
SECTION II Part B: MANAGEMENT AND ADMINISTRATIVE UPDATE-A description of all
meetings, conference calls, etc. that have taken place during the reporting
period. Include progress on administration and management issues (e.g.
evaluating, managing subcontractor performance and personnel changes);
SECTION II Part C: TECHNICAL PROGRESS-For each activity related to Gantt chart,
document the results of work completed and cost 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 to
explain any significant results achieved and preliminary conclusions resulting
from analysis and scientific evaluation of data accumulated to date under the
contract. The report shall include a description of problems encountered and
proposed corrective action; differences between planned and actual progress, why
the differences have occurred and what corrective actions are planned;
preliminary conclusions resulting from analysis and scientific evaluation of
data accumulated to date under the project;
SECTION II Part D; PROPOSED WORK- A summary of work proposed for the next
reporting period; and preprints/reprints of papers, abstracts and a
current/updated Gantt chart.  A Quarterly Progress Report will not be required
in the same month that the Annual Progress Report is submitted.
SECTION III Part A: Earned Value Management Reporting: Contractor will provide a
quarterly Contract Performance Report (CPR) at an agreed upon reporting level
using the BARDA provided WBS and a Variance Analysis Report.  EVMS shall be
applied to all Cost Plus Fixed Fee CLINs as part of the Integrated Master
Project Plan following the Seven Principles of Earned Value Management.  BARDA
may request, on a quarterly or ad hoc basis that the Contractor provide raw
data.  BARDA may request additional data at a reporting level or at lower
levels, as BARDA deems necessary

 
C.
Annual Progress Report

This report shall include a summation 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 year of performance plus any
fractional part of the initial year. Thereafter, the reporting period shall
consist of each calendar year.

The Contractor shall submit an Annual Progress Report on or before the 15th
calendar day following the last day of each reporting period and shall include
the following:
A cover page that includes the contract number and title; the type of report and
period that it covers; the Contractor's name, address, telephone number, fax
number, and e-mail address; and the date of submission;

SECTION I-EXECUTIVE SUMMARY - A brief overview of the work completed and major
accomplishments achieved during the reporting period.
SECTION II-PROGRESS
SECTION II Part A: OVERALL PROGRESS-A description of overall progress;

 
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SECTION II Part B: MANAGEMENT AND ADMINISTRATIVE UPDATE-A description of all
meetings, conference calls, etc. that have taken place during the reporting
period. Include progress on administration and management issues (e.g.
evaluating, and managing subcontractor performance);
SECTION II Part C: TECHNICAL PROGRESS-For each activity, document the results of
work completed and cost 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 to explain any significant
results achieved and preliminary conclusions resulting from analysis and
scientific evaluation of data accumulated to date under the contract. The report
shall include a description of problems encountered and proposed corrective
action; differences between planned and actual progress, why the differences
have occurred and what corrective actions are planned; preliminary conclusions
resulting from analysis and scientific evaluation of data accumulated to date
under the project;
SECTION II Part D; PROPOSED WORK- A summary of work proposed for the next
reporting period; and preprints/reprints of papers, abstracts and a current
Gantt chart. An Annual Progress Report will not be required for the period when
the Final Technical Progress Report is due and a Monthly Progress Report will
not be required in the same month that the Annual Progress Report is submitted.

 
D.
Draft Final Technical Progress Report and Final Technical Progress Report

These reports are to include a summation of the work performed and results
obtained for the entire contract period of performance. This report shall be in
sufficient detail to describe comprehensively the results achieved. The Draft
Final Report and Final Report shall be submitted in accordance with the
DELIVERIES Article in SECTION F of the contract. The Draft Final Technical
Progress Report shall be submitted one hundred twenty (120) calendar days before
completion date of the contract and the Revised Final Technical Progress Report
shall be submitted at sixty (60) calendar days before the completion date of the
contract. 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,
e-mail address and submission date;

(2)      SECTION I: EXECUTIVE SUMMARY-Summarize the purpose 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, the
results obtained, and the impact of the results on the scientific and/or public
health community, including a listing of all manuscripts (published and in
preparation) and abstracts presented during the entire period of performance,
and a summary of all inventions.

Draft Final Technical Progress Report: The Contractor is required to submit the
Draft Final Technical Progress Report to the Contracting Officer's Technical
Representative and Contracting Officer. This report is due 120 calendar days
before the completion date of the contract. The Contracting Officer's Technical
Representative and Contracting Officer will review the Draft Final Technical
Progress Report and provide the Contractor with comments within 45 calendar days
after receipt.

Final Technical Progress Report: The contractor shall incorporate all BARDA
comments into the Final Technical Progress Report. The Contractor will deliver
the final version of the Final Technical Progress Report on or before the
completion date of the contract.

 
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E.
Summary of Salient Results

 
The Contractor shall submit, with the Final Technical Progress Report, a summary
(not to exceed 200 words) of salient results achieved during the performance of
the contract.
 
 
F.
Audit Reports

 
Within thirty (30) calendar days of an audit related to conformance to FDA
regulations and guidance, including adherence to GLP, GMP, or GCP guidelines,
the Contractor shall provide copies of the audit report and a plan for
addressing areas of nonconformance to FDA regulations and guidance for GLP, GMP,
or GCP guidelines as identified in the final audit report.
 
 
G.
Clinical and Non-Clinical Trial Protocols

 
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 Issues

 
 
i.
PHS Policy on Humane Care and use of Laboratory Animals

Before award and then with the annual progress report, the Contractor must
submit to BARDA a copy of the current IACUC documentation of continuing review
and approval and the OLAW federalwide 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 the protocol. They must
also provide BARDA initial and annual documentation of continuing review and
approval and federalwide number.

The Contractor must ensure that the application, as well as all protocols, is
reviewed by their IACUC.

To help ensure the safety of animals used in BARDA-funded studies, the
Contractor must provide BARDA copies of documents related to all major changes
in the status of ongoing protocols, including the following:

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

 
·
All 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 for the indicated
study(ies).

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

Contractor must notify BARDA of any of the above changes within five working
days 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 the initial 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

BARDA strongly recommends continued safety monitoring for all non-clinical
studies of investigational drugs, devices, or biologics. In preparation for
clinical trails of licensed or not yet licensed products, it is imperative that
BARDA-sponsored studies of any type measure the risk and safety parameters that
are elicited and proved 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 than those ordinarily
encountered in daily life or during the performance of routine 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 a routine physical examination (45 CFR
46.102(i)).

BARDA will work with the Contractor on decisions regarding the type and extent
of safety data accrual to be employed before the start of efficacy or safety
studies.

 
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 approval by BARDA.

 
·
IACUC approved (signed) non-clinical research protocol identified by version
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 federalwide number, IACUC
registration number, and IACUC name.

 
·
Plans for the management of side effects, rules for interventions and euthanasia
criteria.

 
·
Procedures for assessing and collecting safety data were appropriate.

 
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·
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 and excipients, and laboratory services
(including histopathology).

 
·
Documentation that the Contractor and all required staff responsible for the
conduct of the research have received training in the protection and handling of
animals, or that the CRO has the required documentation.

BARDA staff comments will be forwarded to the Contractor within two weeks (10
business days) of receipt of the above information. The Contractor must address
in writing all safety, regulatory, ethical, and conflict of interest concerns
raised by BARDA staff to the satisfaction of BARDA before study execution. After
receiving the corrected documentation, that satisfies BARDA staff the BARDA
Contracting Officer will provide a written Contract Officer Authorization (COA)
Letter to the Contractor. This COA provides authorization to the Contractor to
execute the specific clinical study funded in part or in whole by BARDA.

In case of problems or issues, the BARDA program officer will contract the
Contractor within two weeks (10 business days) by email or fax, followed within
30 calendar days by an official letter to the Contractor’s Project Leader with a
copy to the financial signatory, listing issues and appropriate actions to be
discussed.

Final decisions regarding ongoing safety reporting requirements for research not
performed under an IND or IDE must be made jointly by the BARDA and the
Contractor.

 
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
http://awic.nal.usda.gov/nal_display/index.php?info_center=3&tax_subject=182&topic_id=1118&level3_id=6735&level4_id=0&level5_id=0&placement_default=0

2.    Clinical Terms of Award

These 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 clinical research.

Safety and Monitoring Issues

a. Institutional Review Board or Independent Ethics Committee Approval

Before award and then with the annual progress report, the Contractor must
submit to BARDA a copy of the current IRB-or IEC-approved informed consent
document, documentation of continuing review and approval and the OHRP
federalwide 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 the
protocol. They must also provide BARDA initial and annual documentation of
continuing review and approval, including the current approved informed consent
document and federalwide number.

 
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The Contractor must ensure that the application as well as all protocols is
reviewed by their IRB or IEC.

To help ensure the safety of participants enrolled in BARDA-funded studies, the
Contractor must provide BARDA copies of documents related to all major changes
in the statues of ongoing protocols, including the following:

 
·
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 the studies.

The Contractor must notify ASPR through the Project Officer (PO) or Contracting
Officer (CO) of any of the above changes within five working days by email or
fax, followed by a letter signed by the institutional business official,
detailing notification of the change of status to the local IRB and a copy of
any responses form the IRB or IEC.

If a 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 the initial and ongoing review and approval, if
any.  See the NIH Guidelines for Research Involving Recombinant DNA Molecules.

b. Data and Safety Monitoring Requirements

BARDA strongly recommends independent safety monitoring for clinical trials of
investigational drugs, devices, or biologics; clinical trial of licensed
products; and clinical research of any type involving more than minimal 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.

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 a small
amount of blood form a healthy individual for research purposes is no greater
than the risk of doing so as part of a routine physical examination (45 CFR
46.102I).

 
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Final decisions regarding the type of monitoring to be used must be made jointly
by BARDA and the Contractor before enrollment starts. Discussions with the
responsible BARDA Project Officer regarding appropriate safety monitoring and
approval of the final monitoring plan by BARDA must occur before patient
enrollment begins and may include discussions about the appointment of one of
the following.

 
·
Independent Safety Monitor – a physician or other appropriate expert who is
independent of the study and available in real time to review and recommend
appropriate action regarding adverse events and other safety issues.

 
·
Independent Monitoring Committee (IMC) or Safety Monitoring Committee (SMC) – a
small group of independent investigators and biostatisticians who review data
from a particular study.

 
·
Data and Safety Monitoring Board – an independent committee charged with
reviewing safety and trial progress and providing advice with respect to study
continuation, modification, and termination. The Contractor may be required to
use an established BARDA DSMB or to organize an independent DSMB. All phase III
clinical trials must be reviewed by a DSMB; other trials may require DSMB
oversight as well. 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 and plan
for review of adverse events), and roster and curriculum vitae from all members
must be submitted to and approved by BARDA 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 of this. The
Contractor will share conflict of interest reports with BARDA.

Additionally, the Contractor must submit written summaries of all reviews
conducted by the monitoring group to the BARDA within 30 days of reviews or
meetings.

 
H.
BARDA Protocol Review Process Before Patient Enrollment Begins

The contractor will provide BARDA with a draft copy of the initial clinical
protocol for review. BARDA staff comments will be forwarded to the Contractor
within three weeks (15 business days) of receipt of the above information. The
Contractor will also provide any amendments or subsequent versions of protocols
to BARDA. BARDA staff comments will be provided within two week (10 business
days) of receipt for subsequent versions. The Contractor must address in writing
all safety, regulatory, ethical, and conflict of interest concerns raised by the
Contracting Officer’s Technical Representative (COTR) to the satisfaction of
BARDA before patient accrual or participant enrollment can begin. After
receiving the corrected documentation that satisfies BARDA staff, the AMCG
Contracting Officer will provide a written Contract Officer Authorization (COA)
Letter to the Contractor. This COA provides authorization to the Contractor to
execute the specific clinical study funded in part or in whole by BARDA.

BARDA has a responsibility to ensure that mechanisms and procedures are in place
to protect the safety of participants in BARDA-supported clinical trial.
Therefore, before patient accrual or participant enrollment, the Contractor must
ensure the following (as applicable) are in place prior to patient accrual or
enrollment at each participating institution.

 
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·   IRB- or IEC-approved clinical research protocol identified by version
number, date, or both, including details of study design, proposed
interventions, patient eligibility, and exclusion criteria.

·   Documentation of IRB or IEC approval, including OHRP federalwide number, IRB
or IEC registration number, and IRB and IEC name.

·   IRB or IEC approved informed consent document, identified by version 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 B above) and monitoring of the
clinical study site, pharmacy, and laboratory.

·   Documentation that the Contractor and all study staff responsible for the
design or conduct of the research have received training in the protection of
human subjects.

I.      Investigational New drug or Investigational Devise Exemption
Requirements

Consistent with federal regulations, clinical research projects involving the
use 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 BARDA with
the name and institution of the IND or IDE sponsor, the date the IND or IDE was
filed with FDA, the FDA IND or IDE number, any written comments form GDA, and
the written responses to those comments.

The Contractor must wait 30 days from FDA receipt of an initial IND or IDE
application before initiating a clinical trial.

The Contractor must notify BARDA if the FDA places the study on clinical hold
and provide BARDA any written comments from FDA, written responses to the
comments, and documentation in writing that the hold has been lifted.

The Contractor must not enter into any new financial obligations related to
clinical activities for the clinical trial on clinical hold.

J.     Required Time-Sensitive Notification

Under an IND or IDE, the sponsor must provide FDA safety reports of serious
adverse events. Under these Clinical Terms of Award, the Contractor must submit
copies to the responsible BARDA Project Officer or the Contracting Officer’s
technical representative (COTR) as follows:

 
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·   Expedited safety report of unexpected or life-threatening experience or
death – A copy of any report of unexpected or life-threatening experience or
death associated with the use of an IND drug, which must be reported to FDA by
telephone or fax as soon as possible but no later than seven days after the IND
sponsor’s receipt of the information, must be submitted to the BARDA program
officer or the contracting officer’s technical representative within 24 house of
FDA notification.

·   Expedited safety reports of serious and unexpected adverse experiences – A
copy of any report of unexpected an serious adverse experience associated with
use of an IND drug or any finding form tests in laboratory animals that suggests
a significant risk for human subjects, with 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 BARDA Project Officer or the
Contracting Officer’s Technical Representative within 24 hours of FDA
notification.

·   IDE reports of unanticipated adverse device effect – A copy of any reports
of unanticipated adverse device effect submitted to FDA must be submitted to the
BARDA Project Officer or the Contracting Officer’s Technical Representative
within 24 hours of FDA notification.

·   Expedited safety reports – should be sent to the BARDA Project Officer or
the Contracting Officer’s Technical Representative concurrently with the report
to FDA.

·   Other adverse events documented during the course of the trial should be
included in the annual IND or IDE report and reported to the BARDA annually.

In case of problems or issues, the BARDA Project Officer or the Contracting
Officer’s Technical Representative will contract the Contractor within 10
working days by email or fax, followed within 30 calendar days by an official
letter to the Contractor’s Project Leader, with a copy to the institutions’
office of sponsored programs, listing issues and appropriate actions to be
discussed.

·   Safety reporting for research not performed under an IND or IDE

Final decisions regarding ongoing safety reporting requirements for research not
performed under an IND or IDE must be made jointly by the BARDA Project Officer
or the Contracting Officer’s Technical Representative and the Contractor.

 
K.
OTHER REPORTS/DELIVERABLES

a.  Copies of FDA Correspondence and Meeting Summaries
i.      For any formal meeting with the FDA, the contractor shall forward
initial draft minutes and subsequently final meeting minutes appropriately
formatted within thirty (30) calendar days of the FDA meeting to the BARDA
Contracting Officer’s Technical Representative.
ii.     The contractor shall forward the final draft minutes of any informal
meeting with the FDA to BARDA.
iii.    The contractor shall forward the dates and times of any meeting with the
FDA to BARDA at least 30 days prior to the meeting and make arrangements for
appropriate BARDA staff to attend FDA meetings.
iv.    The contractor shall provide BARDA the opportunity to review and comment
upon any documents to be submitted to the FDA. The contractor shall provide
BARDA with five (5) business days in which to review and provide comments back
to the contractor.

b.  Technology Transfer
Technology packages developed under the contract that include complete protocols
and critical reagents developed and/or improved with contract funding must be
submitted at the request of the BARDA Contracting Officer’s Technical
Representative. See FAR clause 52.227-11 (Patent Rights-Ownership by the
Contractor).

 
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c. Institutional Biosafety Approval
The Contractor shall provide documentation of materials submitted for
Institutional Biosafety Committee Review and documentation of approval of
experiments at the request of the BARDA Contracting Officer’s Technical
Representative.

d. Study/Experiment/Test Plans
The Contractor shall submit all study/experiment/test plans, designs, and
protocols upon request by the COTR.

e. Data
The Contractor shall provide data or specific analysis of data generated with
contract funding at the request of the BARDA Contracting Officer’s Technical
Representative. See FAR clause 52.227-14 (Rights in Data-General).

f. Meeting Minutes
The Contractor shall provide an electronic copy of conference call meeting
minutes/summaries to the BARDA Contracting Officer’s Technical Representative
and Contracting Officer within seven (7) calendar days after the conference call
is held.

ARTICLE C.3. SUBJECT INVENTION REPORTING REQUIREMENT

All reports and documentation required by FAR Clause 52.227-11, including, but
not limited to, the invention disclosure report, the confirmatory license, and
the Government support certification, shall be directed to the Extramural
Inventions and Technology Resources Branch, OPERA, NIH, 6705 Rockledge Drive,
Room 2207,  MSC 7987, Bethesda, Maryland 20892-7987 (Telephone:301-435-1986). In
addition, one copy of an annual utilization report, and a copy of the final
invention statement, shall be submitted to the Contracting Officer.  The final
invention statement (see FAR 27.303 (b)(2)(ii)) shall be submitted to the
Contracting Officer on the expiration date of the contract. See also FAR clause
52.227-11 (Patent Rights-Ownership by the Contractor).

Please provide an additional electronic copy of all reports and documents to the
Contracting Officer and Contract Specialist. Reports and documentation submitted
to the Contracting Officer and Contract Specialist shall be sent to the
following address.

Contracting Officer – […***…]
Contract Specialist- […***…]
Office of Acquisition Management, Contracts, and Grants (AMCG)
330 Independence Avenue, S.W.
Room G640
Washington, D.C. 20201

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

To assist contractors in complying with invention reporting requirements of the
clause, “Interagency Edison,” An electronic invention reporting system has been
developed. Use of Interagency Edison is encouraged as it streamlines the
reporting process and greatly reduces paperwork. Access to the system is through
a secure interactive Web site to ensure that all information submitted is
protected. Interagency Edison and information relating to the capabilities of
the system can be obtained from the Web (http://www.iedison.gov), or by
contacting the Extramural Inventions and Technology Resources Branch, OPERA,
NIH.
 
*Confidential Treatment Requested
 
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ARTICLE C.4. TWICE MONTHLY CONFERENCE CALLS
A conference call between the Contracting Officer’s Technical Representative and
designees and the Contractor’s Project Leader and designees shall occur
bi-monthly or as directed by the Contracting Officer’s Technical Representative.
During this call the Contractor’s Project Leader and designees will discuss the
activities during the reporting period, any problems that have arisen 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’s Project Leader may choose to include other key personnel
on the conference call to give detailed updates on specific projects or this may
be requested by the Contracting Officer’s Technical Representative.

ARTICLE C.5. PROJECT MEETINGS
The contractor shall participate in Project Meetings to coordinate the
performance of the contract, as requested by the Contracting Officer’s Technical
Representative. These meetings may include face-to-face meetings with AMCG/BARDA
in Washington, D.C. and at work sites of the Contractor. Such meetings may
include, but are not limited to, meetings of the Contractor to discuss study
designs, site visits to the Contractor’s facilities, and meetings with the
Contractor and HHS officials to discuss the technical, regulatory, and ethical
aspects of the program. Subject to the data rights provisions in this contract,
the Contractor must provide data, reports, and presentations to groups of
outside experts and USG personnel as required by the Contracting Officer’s
technical Representative in order to facilitate review of contract activities

SECTION D – PACKAGING, MARKING AND SHIPPING

All deliverables required under this contract shall be packaged, marked and
shipped in accordance with Government specifications.  At a minimum, all
deliverables shall be marked with the contract number and Contractor name.  The
Contractor shall guarantee that all required materials shall be delivered in
immediate usable and acceptable condition.

SECTION E – INSPECTION AND ACCEPTANCE

 
1.
The Contracting Officer or the duly authorized representative will perform
inspection and acceptance of materials and services to be provided.

 
2.
For the purpose of this SECTON, the designated Contracting Officer’s Technical
Representative is the authorized representative of the Contracting Officer.

 
3.
Inspection and acceptance will be performed at:

Biomedical Advanced Research and Development Authority/Office of Acquisition
Management, Contracts, and Grants (AMCG)
Office of the Assistant Secretary for Preparedness and Response
U.S. Department of Health and Human Services
330 Independence Avenue, S.W., Room G640
Washington, D.C. 20201

 
4.
The contract incorporates the following clause by reference with the same force
and effect as if it were given in full text. Upon request, the Contracting
Officer will make its full text available.

 
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FAR Clause 52.246-9, Inspection of Research and Development (Short Form)(Apr
1984)

SECTION F – DELIVERIES OR PERFORMANCE

ARTICLE F.1. ESTIMATED PERIOD OF PERFORMANCE

a.        Under CLIN 0001, the estimated period of performance for the base work
segment of this contract shall be from 2/11/2011-2/10/2012. As discussed under
Article B.1 above this estimated period of performance is subject to adjustment.
The period of performance for each of the Option work segments under CLINS 0002
through 0016 are also subject to adjustment, at the government’s discretion, in
order to complete the tasks required under each work segment.
b.       . If the Government exercises its options pursuant to the OPTION CLAUSE
Article in Section G of the contract the period of performance will be increased
as follows:
 
ARTICLES F.2. DELIVERIES
 
CLIN
 
Estimated Option
Period
 
Supplies/Services
0002
 
12/12/11 – 2/10/16
 
Stability Studies
0003
 
2/11/12 – 7/27/13
 
Animal Efficacy & Initial GMP Production
0004
 
2/11/12 – 7/27/13
 
Safety and CMC
0005
 
2/11/12 – 2/10/14
 
NHP Radiation Dose Evaluation – PBI BM5
0006
 
2/16/12 – 10/2/12
 
Murine Extended Natural History
0007
 
2/29/12 – 7/9/13
 
Mutagenicity/Teratogenicity
0008
 
12/1/12 – 6/30/14
 
NHP AEOL 10150 Delayed Treatment Study
0009
 
2/11/13 – 3/31/14
 
NHP Extended Natural History - WTLI
0010
 
6/13/13 – 1/27/16
 
Fourth Registrational Batch
0011
 
7/28/13 – 7/27/15
 
NHP Pivotal Efficacy Study – WTLI
0012
 
11/11/13 – 7/27/15
 
Manufacturing Scale Up
0013
 
7/28/13 – 7/27/15
 
Pivotal Safety Study
0014
 
7/28/13 – 7/27/15
 
NHP Pivotal Efficacy Study PBI BM5
0015
 
7/28/13 – 7/27/15
 
Long Term Pivotal Safety Study
0016
  
6/10/15 – 2/10/16
  
NDA Preparation and Filing

 
 
21

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Successful performance of the final contract shall be deemed to occur upon
performance of the work described in the Statement of Work Article in SECTION C
of this contract and upon delivery and acceptance by the Contracting Officer, or
the duly authorized representative, of the following items in accordance with
the stated delivery schedule and proposal milestones:

a. The items specified below as described in the REPORTING REQUIREMENTS Article
in SECTION C of this contract will be required to be delivered F.O.B destination
as set forth in the FAR 52.247-35, F.O.B. DESTINATION, WITIN CONSIGNEES PREMISES
(April 1984), and in accordance with and by the date(s) specified below and any
specifications stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of this
contract:

Item
 
Description
 
Quantity
 
Addresses
 
Deliver Schedule
Technical Progress Reports
1)
 
Monthly Progress
Report
 
2 electronic
 
CS: (1) electronic copy
 
COTR: One (1)
electronic
 
The 15th calendar day of each month following the first full month of the
contract award. The Monthly Progress Report will not be required on months when
an Annual or Quarterly Progress Report is due.
 
2)
 
Annual Progress
Report
 
2 electronic
 
Same as CS and COTR above
 
45 calendar days prior to the end of each base or option period. In person
presentation of annual progress may be required at the BARDA location. The
Monthly Progress Report will not be required on months when an Annual Progress
Report is due.
 
3)
 
Draft Final Technical Progress Report
 
2 electronic
 
Same as CS and COTR above
 
120 Calendar days before the completion date of the contract
 
4)
 
Final Technical
Progress Report
 
2 electronic
 
 
Same as CS and COTR above
 
On or before the expiration date of the contract
5)
 
Summary of salient
Results
 
2 electronic
 
 
Same as CS and COTR above
 
On or before the expiration date of the contract
Other Technical Reports
                     
6)
  
Audit Reports
  
2 electronic
  
Same as CS and COTR
above
  
Within 30 Calendar days of the audit

Other Reports

7)
 
FDA Correspondence
And Meeting
Summaries
 
1 electronic
 
Same as COTR
 
Within 30 calendar days of receiving correspondence or meeting with the FDA
8)
 
Invention Report
Annual Utilization
Report
 
2 electronic
 
1 electronic to OPERA.
CS: 1 electronic
 
Due on or before the 30th of the month following each anniversary date of the
contract.
9)
  
Final Invention
Report
  
2 electronic
  
1 electronic to OPERA.
CS: 1 electronic
  
Due on or before the completion date of the contract.

 
22

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10)
 
Final Inventory
 
2 electronic
 
Same as CS and COTR above
 
On or before the expiration of the contract.
11)
 
Baseline Evaluation of Current PM, DM, and QA Processes
 
2 electronic
 
Same as CS and COTR above
 
Documentation package to be provided 90 calendar days following contract award;
IBR meeting date TBD
12)
 
EVMS Plan
 
2 electronic
 
Same as CS and COTR above
 
Within 90 days of contract award
13)
 
EVMS Monthly Reports
 
2 electronic
 
Same as CS and COTR above
 
On the 15th business day of each month beginning April 2012*
*(If Option Exercised by BARDA)
14)
 
Integrated Master Schedule
 
2 electronic
 
Same as CS and COTR above
 
IMS with performance data monthly, 10 business days after reporting end
15)
 
Risk Register
 
2 electronic
 
Same as CS and COTR above
 
90 calendar days following contract award and quarterly or as needed thereafter
16)
 
Quarterly Risk Management Plan
 
2 electronic
 
Same as CS and COTR above
 
By the 15th day following the end of each quarterly period
17)
 
Bi-Weekly agendas and minutes
 
2 electronic
 
Same as CS and COTR above
 
Agendas shall be provided 3 business days in advance; minutes within 5 business
days
18)
  
Integrated Product Development Plan
  
2 electronic
  
Same as CS and COTR above
  
Within 30 days of contract start date

For WBS Milestones/Deliverables and Technical Deliverables SEE ATTACHMENT 6

b. The above items shall be delivered via one electronic copy to the Contracting
Officer, Contract Specialist, and COTR.

Additional Addresses Listed for Reference, if needed:

 
AMCG/BARDA Security Specialist
Office of the Assistant Secretary for

Preparedness and Response
Office of Public Health Emergency Medical
Countermeasures
409 3rd Street, S.W. Suite 320
Washington, DC 20201
[…***…]

Address for the Extramural Inventions and Technology Resources Branch (EITRB),
Office of Biodefense Research Affairs:
OPERA
NIH
6705 Rockledge Drive
Room 1040-A
MSC 7980
Bethesda, Maryland 20892-7980
 
*Confidential Treatment Requested
 
23

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ARTICLE F.3. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)

The contract incorporates the following clause(s) by reference, with the same
force and effect as if it were given in full text. Upon request, the Contracting
Officer will make its full text available. Also, the full text of a clause may
be accessed electronically at this address:
http://www.acquisition.gov/comp/far/index.html

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

 52.242-15, Stop Work Order (August 1989) with Alternate I (April 1984).

SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1. CONTRACTING OFFICER'S TECHNICAL REPRESENTATIVE (COTR)

The following Contracting Officer's Technical Representative (COTR) will
represent the Government for the purpose of this contract:

[…***…]
Contracting Officer Technical Representative
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, SW, Room G644
Washington, D.C. 20201
202-205-5998 (Office)
[…***…]

Alternate COTR:
[…***…]
Chemical, Radiological, and Nuclear Medical Countermeasures
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, SW, Room G644
Washington, D.C. 20201
202-260-0400 (Office)
[…***…]

The COTR is responsible for: (1) monitoring the Contractor's technical progress,
including the surveillance and assessment of performance and recommending to the
Contracting Officer changes in requirements; (2) assisting the Contracting
Officer with interpreting the statement of work and any other technical
performance requirements; (3) performing technical evaluation as required; (4)
performing technical inspections and acceptances required by this contract; and
(5) assisting in the resolution of technical problems encountered during
performance.
The Government may unilaterally change its COTR designation.

*Confidential Treatment Requested
 
 
24

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ARTICLE G.2. CONTRACTING OFFICER

 
a.
The Contracting Officer (CO) is the only individual who can legally commit the
Government to the expenditure of public funds. No person other than the
Contracting Officer can make any changes to the terms, conditions, general
provisions or other stipulations of this contract.

 
b.
The Contracting Officer is the only person with authority to act as agent of the
Government 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 the period of performance; (3) change the delivery schedule; (4)
authorize reimbursement to the Contractor for any costs incurred during the
performance of this contract; or (5) otherwise change any terms and conditions
of this contract.

 
c.
No information, other than that which may be contained in an authorized
modification to this contract duly issued by the Contracting Officer, shall be
considered grounds for deviation from this contract.

 
d.
The Government may unilaterally change its CO designation.

ARTICLE G.3. KEY PERSONNEL, HHSAR 352.242-70 (January 2006)

The key personnel specified in this contract are considered to be essential to
work performance. At least 30 days prior to diverting any of the specified
individuals to other programs or contracts (or as soon as possible, if an
individual must be replaced, for example, as a result of leaving the employ of
the Contractor), the Contractor 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. The Government may modify the contract to
add or delete key personnel at the request of the Contractor or Government.
(End of Clause)

The following individuals are considered to be essential to the work being
performed hereunder:

Name
 
Title
[…***…]
 
[…***…]
[…***…]
 
[…***…]

ARTICLE G.4. INVOICE SUBMISSION

The Contractor shall submit one electronic copy of the contract invoices to the
TBD designated Government eRoom.

The billing address that should be shown on the invoice shall be the following:

DHHS/OS/ASPR/AMCG
Attn: Contracting Officer
330 Independence Ave., S.W.
Room G640
Washington, D.C. 20201

The Contractor shall submit an email notification to the Contracting Officer,
Contract Specialist, and Invoice Clerk. The Contractor shall submit one paper
copy Contract Specialist.

Contracting Officer, […***…]
Contract Specialist, […***…]
Invoice Clerk, TBD, TBD
 
*Confidential Treatment Requested
 
25

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ARTICLE G.5. CONTRACT FINANCIAL REPORT

 
i.
Financial reports on the attached Financial Report of Individual
Project/Contract shall be submitted by the Contractor in accordance with the
instructions for completing this form, which accompany the form, in an original
and one electronic copy, not later than the 30th working day after the close of
the reporting period. The line entries for subdivisions of work and 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.

 
ii.
Unless otherwise stated in that part of the instructions for completing this
form, entitled " PREPARATION INSTRUCTIONS ," all columns A through J, shall be
completed for each report submitted.

 
iii.
The first financial report shall cover the period consisting of the first full
three calendar months following the date of the contract, in addition to any
fractional part of the initial month. Thereafter, reports will be on a quarterly
basis.

 
iv.
The Contracting Officer may require the Contractor to submit detailed support
for costs contained in one or more interim financial reports. This clause does
not supersede the record retention requirements in FAR Part 4.7.

 
v.
The listing of expenditure categories to be reported is incorporated within the
Attachment entitled, "Financial Report of Individual Project/Contract," located
in SECTION J and made a part of this contract.

 
vi.
The Government may unilaterally revise the “Financial Report of Individual
Project/Contract” to reflect the allotment of additional funds.

ARTICLE G.6. INDIRECT COST RATES

a.
In accordance with Federal Acquisition Regulation (FAR) (48 CFR Chapter 1)
Clause 52.216-7 (d)(2), Allowable Cost and Payment incorporated by reference in
this contract in PART II, SECTION I, the cognizant Contracting Officer
representative responsible for negotiating provisional and/or final indirect
cost rates for this contract is identified as follows:

[…***…]
330 Independence Ave., S.W.
Room G640
Washington, D.C. 20201

b.
These rates are hereby incorporated without further action of the Contracting
Officer.

ARTICLE G.7. GOVERNMENT PROPERTY

a.
In addition to the requirements of the clause, GOVERNMENT PROPERTY, incorporated
in SECTION I of this contract, the Contractor shall comply with the provisions
of HHS Publication, "Contracting Guide for Contract of Government Property,"
which is incorporated into this contract as an attachment.

 
Among other issues, this publication provides a summary of the Contractor's
responsibilities regarding purchasing authorizations and inventory and reporting
requirements under the contract.

 
*Confidential Treatment Requested
 
26

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b.
Notwithstanding the provisions outlined in the HHS Publication, "Contracting
Guide for Contract of Government Property," which is incorporated in this
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. The location of this form is included as an attachment in
SECTION J of this contract.

c.
Title will vest in the Government for equipment purchased as a direct cost.

ARTICLE G.8. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE
 
a.
Contractor Performance Evaluations

 
Interim and final evaluations of Contractor performance will be prepared on this
contract 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
thirty 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 be referred to an individual one level above the Contracting Officer
whose decision will be final.

b.
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.

c.
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 be obtained at the following address: http://oamp.od.nih.gov/OD/CPS/cps.asp

The registration process requires the Contractor to identify an individual that
will serve as a primary contact and who will be authorized access to the
evaluation for review and comment. In addition, the Contractor will be required
to identify an alternate contact who will be responsible for notifying the
cognizant contracting official in the event the primary contact is unavailable
to process the evaluation within the required 30-day time frame.
 
ARTICLE G.9. CONTRACT COMMUNICATIONS/CORRESPONDENCE (JULY 1999)
 
The Contractor shall identify all correspondence, reports, and other data
pertinent to this contract by imprinting the contract number from Page 1 of the
contract.
 
SECTION H - SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. PROTECTION OF HUMAN SUBJECTS, HHSAR 352.270-4 (January 2006)

a.      The Contractor agrees that the rights and welfare of human subjects
involved in research under this contract shall be protected in accordance with
45 CFR Part 46 and with the Contractor's current Assurance of Compliance on file
with the Office for Human Research Protections (OHRP), Office of Public Health
and Science (OPHS). 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 Compliance.

 
27

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b.      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 the Contractor retains the right to
control and direct the performance of all work under this contract. Nothing in
this contract shall be deemed to constitute the Contractor or any subcontractor,
agent or employee of the Contractor, or any other person, organization,
institution, or group of any kind whatsoever, as the agent or employee of the
Government. 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 imputing liability on the part of the Government for the acts
of the Contractor or its employees.

c.      If at any time during the performance of this contract, the Contracting
Officer determines, in consultation with the OHRP, OPHS, ASH, that the
Contractor is not in compliance with any of the requirements and/or standards
stated in paragraphs (a) and (b) 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 OHRP, OPHS, ASH, terminate this contract in a whole or in
part, and the Contractor's name may be removed form the list of those
contractors with approved Health and Human Services Human Subject Assurances.

(End of clause)

ARTICLE H.2. 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 applicable Federal, 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 a result of research involving human subjects conducted under this
contract, by collaborating sites, or by subcontractors identified under this
contract, were obtained with prior approval by the Office for Human Research
Protections (OHRP) of an Assurance to comply 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
"Protection of 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 required by the
"Protection of Human Subjects Assurance Identification/IRB
Certification/Declaration of Exemption", Form OMB No. 0990-0263(formerly
Optional Form 310).

An Investigational Research Board Number will be provided once the clinical
study site(s) is chosen. The Contractor guarantees that the participating IRB
will comply with OHRP regulations.

 
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ARTICLE H.3. 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 guidance for conducting research on human fetal tissue may be
found at 45 CFR 46, Subpart B and
http://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.4. NEEDLE EXCHANGE

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.5. CARE OF LIVE VERTEBRATE ANIMALS, HHSAR 352.270-5(b) (October 2009)

a.      Before undertaking performance of any contract involving animal related
activities, the Contractor shall register with the Secretary of Agriculture of
the United States in accordance with 7 U.S.C. 2136 and 9 CFR 2.25 through 2.28.
The Contractor shall furnish evidence of the registration to the Contracting
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 2.1 through 2.11, or from a source that is exempt from licensing under those
sections.

c.      The Contractor agrees that the care and use of any live vertebrate
animals used or intended for use in the performance of this contract will
conform with the PHS Policy on Humane Care of Use of Laboratory Animals, the
current Animal Welfare Assurance, the Guide for the Care and Use of Laboratory
Animals prepared by the Institute of Laboratory Animal Resources and the
pertinent laws and regulations 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 be used.

d.      If at any time during performance of this contract, the Contracting
Officer determines, in consultation with the Office of Laboratory Animal Welfare
(OLAW), National Institutes of Health (NIH), that the Contractor is not in
compliance with any of the requirements and/or 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 be removed from the list of those contractors with
approved PHS Animal Welfare 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.

Office of Laboratory Animal Welfare Number A3195-01 Duke Univ.  A3200-1 U of MD

(End of Clause)

 
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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. PROTECTION OF PERSONNEL WHO WORK WITH NONHUMAN 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
Nonhuman Primates," located at the following
URL:  http://www1.od.nih.gov/oma/manualchapters/intramural/3044-2/

ARTICLE H.8.   IDENTIFICATION AND DISPOSITION OF DATA

The 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.  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.9.   INFORMATION ON COMPLIANCE WITH ANIMAL CARE REQUIREMENTS

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.),
http://www.nal.usda.gov/awic/legislat/awa.htm.

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 and use 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)
http://www.nal.usda.gov/awic/legislat/usdaleg1.htm 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 that meet 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 and Teaching.  It is published by
the Federated of Animal Science Societies http://www.fass.org.

 
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ARTICLE H.10. 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
2.25-2.28 is submitted within 30 days of the date of this award 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 2.25-2.28 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 or individual performance sites pending OLAW approval of their
respective assurance of compliance with 7 U.S.C. 2316 and 9 CFR Sections
2.25-2.28.  Additional information regarding OLAW may be obtained via the
Internet at http://grants2.nih.gov/grants/olaw/references/phspol.htm

ARTICLE H.11. EXPORT CONTROL NOTIFICATION

Offerors are responsible for ensuring compliance with all export control laws
and regulations that maybe applicable to the export of and foreign access to
their proposed technologies.  Offerors may consult with the Department of State
with any questions regarding the International Traffic in Arms Regulation (ITAR)
(22 CRF Parts 120-130) and /or the Department of Commerce regarding the Export
Administration Regulations (15 CRF Parts 730-774).

ARTICLE H.12.  REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

Anyone who becomes aware of the existence or apparent existence of fraud, waste
and abuse in AMCG funded programs is encouraged to 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.13. PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST ACTIVITIES

The Contractor acknowledges that U.S. Executive Orders and Laws, including but
not limited to E.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 and Laws. This clause must be included in
all subcontracts issued under this contract.

 
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ARTICLE H.14. CONFLICT OF INTEREST

The Contractor represents and warrants that, to the best of the Contractor's
knowledge and belief, there are no relevant facts or circumstances which could
give rise to an organizational conflict of interest, as defined in FAR Subpart
9.5, or that the Contractor 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 a full 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
termination of this contract for convenience, in whole or in part, if the
Contracting Officer deems such termination necessary to avoid an organizational
conflict of interest. If the Contractor was aware of a potential organizational
conflict of interest prior to award or discovered an actual or potential
conflict after award and did not disclose it or misrepresented relevant
information to the Contracting Officer, the Government may terminate the
contract for default, debar the Contractor from Government contracting, or
pursue such other remedies as may be permitted by law or this contract.

ARTICLE H.15.  PROHIBITION ON THE USE OF APPROPRIATED FUNDS FOR LOBBYING
ACTIVITIES AND HHSAR 352.203-70 ANTI-LOBBYING (Jan 2006)

The Contractor is hereby notified of the restrictions on the use of Department
of Health and Human Service's funding for lobbying of Federal, State and Local
legislative bodies.

Section 1352 of Title 31, United Stated Code (Public Law 101-121, effective
12/23/89), among other things, prohibits a recipient (and their subcontractors)
of a Federal contract, grant, loan, or cooperative agreement from using
appropriated funds (other than profits from a federal contract) to pay any
person for influencing or attempting to influence an officer or employee of any
agency, a Member of Congress, an officer or employee of Congress, or an employee
of a Member of Congress in connection with any of the following 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 352.270-10 “Anti-Lobbying” (January 2006),
the current Department of Health and Human Services Appropriations Act provides
that no part of any appropriation contained in this Act shall be used, other
than for normal and recognized executive-legislative relationships, for
publicity or propaganda purposes, for the 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 to any activity designed to influence
legislation or appropriations pending before the Congress, or any State or Local
legislature.

(End of Clause)
 
ARTICLE H.16. REVIEW OF PRESS RELEASES
 
The contractor agrees to accurately and factually represent the work conducted
under the contract in all press releases. Misrepresenting contract results or
releasing information that is injurious to the integrity of BARDA may be
construed as improper conduct.   Press releases shall be considered to include
the public release of information to any medium, excluding peer-reviewed
scientific publications. The contractor shall ensure that the project officer
has received an advance copy of any press release related to the contract not
less than four (4) working days prior to the issuance of the press release.

 
32

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ARTICLE H.17. EXERCISE OF OPTIONS

Unless the Government exercises its option pursuant to the Option Clause set
forth in Section I, Article I.1, the contract will consist only of CLIN 0001 of
the Statement of Work, Deliverables and Requirements as defined in Sections C, F
and J of the contract.  Pursuant to FAR Clause 52.217-9 (Option to Extend the
Term of the Contract) set forth in Section I of this contract, under Article
I.1., the Government may, by unilateral contract modification, require the
Contractor to perform any of the additional CLINs listed in Section B, Article
B.3., and as also defined in Sections C, F and J of this contract as well as the
deliverables specified on Attachment 6.  If the Government exercises an option,
notice must be given within 60 days after the government has completed its
analysis of the deliverables associated with the applicable GO/NO GO criteria
specified under Attachment 6; provided that the Government gives the Contractor
a preliminary written notice of its intent to extend performance at least 30
days prior to the expiration date of the Period of Performance (PoP) applicable
to the base work segment or the PoP applicable to any option segment.  The
amount of the contract may then be increased as set forth in Section B, Article
B.3 provided that funds are available at the time BARDA, at its sole discretion
chooses to exercise the option work segment.

ARTICLE H.18. PUBLICATION AND PUBLICITY

No information related to data obtained under this contract shall be released or
publicized without the prior written consent of the Contracting Officer
Technical Representative.
In addition to the requirements set forth in HHSAR Clause 352.227-70,
Publications and Publicity incorporated by reference in SECTION I of this
contract, the Contractor shall acknowledge the support of the 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
Biomedical Advanced Research and Development Authority, Office of the Assistant
Secretary for Preparedness and Response, Office of the Secretary, Department of
Health and Human Services, under Contract No.                           "

ARTICLE H.19. PRESS RELEASES

The Contractor shall clearly state, when issuing statements, press releases,
requests for proposals, bid solicitations and other documents describing
projects or programs funded in whole or in part with Federal money: (1) the
percentage of the total costs of the program or project which will be financed
with Federal money; (2) the dollar amount of Federal funds for the project or
program; and (3) the percentage and dollar amount of the total costs of the
project or program that will be financed by nongovernmental sources.
 
ARTICLE H.20. INSTITUTIONAL RESPONSIBILITY REGARDING CONFLICTING INTERESTS OF
INVESTIGATORS
 
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 principal investigator
and any other person who is responsible for the design, conduct, or reporting of
research funded under BARDA contracts) will not be biased by any conflicting
financial interest.  For the purposes of this part relating to financial
interests, "Investigator" includes the Investigator's spouse and dependent
children.  45 CFR Part 94 is available at the following Web site:
 
http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr;sid=9f130b6d2d48bb73803ca91ce943be3a;rgn=div5;view=text;node=45%3A1.0.1.1.53;idno=45;cc=ecfr

 
33

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As required by 45 CFR Part 94, the Contractor shall, at a minimum:
 
a.   Maintain a written, enforceable policy on conflict of interest that
complies with 45 CFR Part 94 and inform each investigator of the policy, the
investigator's reporting responsibilities, and the applicable regulations. The
Contractor must take reasonable steps to ensure that investigators working as
collaborators or subcontractors comply with the regulations.
 
b.   Designate an official(s) to solicit and review financial disclosure
statements from each investigator participating in BARDA-funded research. Based
on established guidelines consistent with the regulations, the designated
official(s) must determine whether a conflict of interest exists, and if so,
determine what actions should be taken to manage, reduce, or eliminate such
conflict. A conflict of interest exists when the designated official(s)
reasonably determines that a Significant Financial Interest could directly and
significantly affect the design, conduct, or reporting of the BARDA-funded
research. The Contractor may require the management of other conflicting
financial interests in addition to those described in this paragraph, as it
deems appropriate. Examples of conditions or restrictions that might be imposed
to manage actual or potential conflicts of interests are included in 45 CFR Part
94, under Management of Conflicting Interests.
 
c.   Require all financial disclosures to be updated during the period of the
award, either on an annual basis or as new reportable Significant Financial
Interests are obtained.
 
d.   Maintain records, identifiable to each award, of all financial disclosures
and all actions taken by the Contractor with respect to each conflicting
interest 3 years after final payment or, where applicable, for the other time
periods specified in 48 CFR Part 4, subpart 4.7, Contract Records Retention.
 
e.   Establish adequate enforcement mechanisms and provide for sanctions where
appropriate.
 
If a conflict of interest is identified, the Contractor shall report to the
Contracting Officer the existence of the conflicting interest found. This report
shall be made and the conflicting interest managed, reduced, or eliminated, at
least on a temporary basis, within sixty (60) days of that identification.
 
If the failure of an investigator to comply with the conflict of interest policy
has biased the design, 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 take appropriate action or
refer the matter to the Contractor for further action which may include
directions to the Contractor on how to maintain appropriate objectivity in the
funded research.
 
The Contracting Officer may at any time inquire into the Contractor's procedures
and actions regarding conflicts of interests in BARDA-funded research including
a review of all records pertinent to compliance with 45 CFR Part 94. The
Contracting Officer may require submission of the records or review them on
site. On the basis of this review, the Contracting Officer may decide that a
particular conflict of interest will bias the objectivity of the BARDA-funded
research to such an extent that further corrective action is needed or that the
Contractor has not managed, reduced, or eliminated the conflict of interest. The
issuance of a Stop Work Order by the Contracting Officer may be necessary 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
conflict of interest that was not disclosed or managed, the Contractor must
require disclosure of the conflict of interest in each public presentation of
the results of the research.

 
34

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PART II - CONTRACT CLAUSES

SECTION I - CONTRACT CLAUSES

ARTICLE I.1.  General Clauses for a Cost-Reimbursement Research and Development
Contract

This contract incorporates the following clauses by reference, with the same
force and effect as if they were given in full text. Upon request, the
Contracting Officer will make their full text available. Also, the full text of
a clause may be accessed electronically at this address:
http://www.arnet.gov/far/.

a.
FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:

.FAR.
.CLAUSE NO..
 
.DATE.
 
.TITLE.
52.202-1
 
Jul 2004
 
Definitions (Over $100,000)
52.203-3
 
Apr 1984
 
Gratuities (Over $100,000)
52.203-5
 
Apr 1984
 
Covenant Against Contingent Fees (Over $100,000)
52.203-6
 
Sep 2006
 
Restrictions on Subcontractor Sales to the Government (Over $100,000)
52.203-7
 
Oct 2010
 
Anti-Kickback Procedures (Over $100,000)
52.203-8
 
Jan 1997
 
Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity
(Over $100,000)
52.203-10
 
Jan 1997
 
Price or Fee Adjustment for Illegal or Improper Activity (Over $100,000)
52.203-12
 
Oct 2010
 
Limitation on Payments to Influence Certain Federal Transactions (Over $100,000)
52.203-13
 
Apr 2010
 
Contractor Code of Business Ethics and Conduct
52.203-14
 
Dec 2007
 
Display of Hotline Poster(s
52.204-4
 
Aug 2000
 
Printed or Copied Double-Sided on Recycled Paper (Over $100,000)
52.204-7
 
Apr 2008
 
Central Contractor Registration
52.204-10
 
Jul 2010
 
Reporting Executive Compensation and First-Tier Subcontract Awards ($25,000 or
more)
52.209-6
 
Sep 2006
 
Protecting the Government's Interests When Subcontracting With Contractors
Debarred, Suspended, or Proposed for Debarment (Over $30,000)
52.215-2
 
Oct 2010
 
Audit and Records - Negotiation [Note: Applies to ALL contracts funded in whole
or in part with Recovery Act funds, regardless of dollar value, AND contracts
over $100,000 funded exclusively with non-Recovery Act funds.]
52.215-8
 
Oct 1997
 
Order of Precedence - Uniform Contract Format
52.215-10
 
Oct 2010
 
Price Reduction for Defective Cost or Pricing Data (Over $700,000)
52.215-12
 
Oct 2010
 
Subcontractor Cost or Pricing Data (Over $700,000)
52.215-14
 
Oct 2010
 
Integrity of Unit Prices (Over $150,000)
52.215-15
 
Oct 2010
 
Pension Adjustments and Asset Reversions
52.215-18
 
Jul 2005
 
Reversion or Adjustment of Plans for Post-Retirement Benefits (PRB) other than
Pensions
52.215-19
 
Oct 1997
 
Notification of Ownership Changes
52.215-21
 
Oct 2010
 
Requirements for Cost or Pricing Data or Information Other Than Cost or Pricing
Data - Modifications
52.215-23
 
Oct 2009
 
Limitations on Pass-Through Charges (Over the Simplified Acquisition threshold)

 
35

--------------------------------------------------------------------------------

 

.FAR.
.CLAUSE NO..
 
.DATE.
 
.TITLE.
52.216-7
 
Dec 2002
 
Allowable Cost and Payment
52.216-8
 
Mar 1997
 
Fixed Fee
52.219-8
 
May 2004
 
Utilization of Small Business Concerns (Over the Simplified Acquisition
threshold))
52.219-9
 
Oct 2010
 
Small Business Subcontracting Plan (Over $650,000, $1.5M for Construction)
52.219-16
 
Jan 1999
 
Liquidated Damages - Subcontracting Plan (Over $650,000, $1.5M for Construction)
52.222-3
 
Jun 2003
 
Convict Labor
52.222-21
 
Feb 1999
 
Prohibition of Segregated Facilities
52.222-26
 
Mar 2007
 
Equal Opportunity
52.222-35
 
Sep 2010
 
Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era,
and Other Eligible Veterans (Over $100,000)
52.222-36
 
Oct 2010
 
Affirmative Action for Workers with Disabilities
52.222-37
 
Sep 2010
 
Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era,
and Other Eligible Veterans (Over $100,000)
52.222-50
 
Feb 2009
 
Combating Trafficking in Persons
52.222-54
 
Jan 2009
 
Employment Eligibility Verification (Over the Simplified Acquisition Threshold)
52.223-6
 
May 2001
 
Drug-Free Workplace
52.223-14
 
Aug 2003
 
Toxic Chemical Release Reporting (Over $100,000)
52.223-18
 
Sep 2010
 
Contractor Policy to Ban Text Messaging While Driving
52.225-1
 
Feb 2009
 
Buy American Act - Supplies
52.225-13
 
Jun 2008
 
Restrictions on Certain Foreign Purchases
52.227-1
 
Dec 2007
 
Authorization and Consent, Alternate I (Apr 1984)
52.227-2
 
Dec 2007
 
Notice and Assistance Regarding Patent and Copyright Infringement
52.227-11
 
Dec 2007
 
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 of reporting in (i) is annual.
52.227-14
 
Dec 2007
 
Rights in Data - General
52.232-9
 
Apr 1984
 
Limitation on Withholding of Payments
52.232-17
 
Oct 2010
 
Interest (Over $100,000)
52.232-20
 
Apr 1984
 
Limitation of Cost
52.232-23
 
Jan 1986
 
Assignment of Claims
52.232-25
 
Oct 2008
 
Prompt Payment, Alternate I (Feb 2002)
52.232-33
 
Oct 2003
 
Payment by Electronic Funds Transfer—Central Contractor Registration
52.233-1
 
Jul 2002
 
Disputes
52.233-3
 
Aug 1996
 
Protest After Award, Alternate I (Jun 1985)
52.233-4
 
Oct 2004
 
Applicable Law for Breach of Contract Claim
52.242-1
 
Apr 1984
 
Notice of Intent to Disallow Costs
52.242-3
 
May 2001
 
Penalties for Unallowable Costs (Over $700,000)
52.242-4
 
Jan 1997
 
Certification of Final Indirect Costs
52.242-13
 
Jul 1995
 
Bankruptcy (Over Simplified Acquisition Threshold))
52.243-2
 
Aug 1987
 
Changes - Cost Reimbursement, Alternate V (Apr 1984)
52.244-2
 
Oct 2010
 
Subcontracts, Alternate I (June 2007) (Over Simplified Acquisition Threshold)
52.244-5
 
Dec 1996
 
Competition in Subcontracting ) (Over Simplified Acquisition Threshold)
52.244-6
 
Oct 2010
 
Subcontracts for Commercial Items

 
36

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.FAR.
.CLAUSE NO..
 
.DATE.
 
.TITLE.
52.245-1
 
Aug 2010
 
Government Property
52.245-9
 
Aug 2010
 
Use and Charges
52.246-23
 
Feb 1997
 
Limitation of Liability ) (Over Simplified Acquisition Threshold)
52.249-6
 
May 2004
 
Termination (Cost-Reimbursement)
52.249-14
 
Apr 1984
 
Excusable Delays
52.251-1
 
Aug 2010
 
Government Supply Sources
52.253-1
 
Jan 1991
 
Computer Generated Forms

 
b.
DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48 CFR
CHAPTER 3) CLAUSES:

 
.HHSAR.
.CLAUSE NO..U
 
.DATE.
 
.TITLE.
352.202-1
 
Jan 2006
 
Definitions - with Alternate paragraph (h) (Jan 2006)
352.203-70
 
Jan 2006
 
Anti-Lobbying (Over Simplified Acquisition Threshold)
352.216-70
 
Jan 2006
 
Additional Cost Principles
352.222-70
 
Jan 2010
 
Contractor Cooperation in Equal Employment opportunity Investigations
352.224-70
 
Jan 2006
 
Privacy Act
352.227-70
 
Jan 2006
 
Publications and Publicity
352.228-7
 
Dec 1991
 
Insurance - Liability to Third Persons
352.233-71
 
Jan 2006
 
Litigation and Claims
352.242-70
 
Jan 2006
 
Key Personnel
352.242-73
 
Jan 2006
 
Withholding of Contract Payments
352.242-74
  
Apr 1984
  
Final Decisions on Audit Findings

 
[End of GENERAL CLAUSES FOR A NEGOTIATED COST-REIMBURSEMENT RESEARCH AND
DEVELOPMENT CONTRACT-Rev. 03/2009].

ARTICLE I.2.  AUTHORIZED SUBSTITUTION OF CLAUSES
(Reserved)

ARTICLE I.3. Additional Contract Clauses

This contract incorporates the following clauses by reference, with the same
force and effect, as if they were given in full text.  Upon request, the
Contracting Officer will make their full text available.

a.
FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES

 
1.
FAR Clause 52.215-17, Waiver of Facilities Capital Cost of Money (October 1997).

 
2.
FAR Clause 52.219-25, Small Disadvantaged Business Participation
Program—Disadvantaged Status and Reporting (April 2008) (November 19 2009
Deviation)

 
3.
FAR Clause 52.227-16, Additional Data Requirements (June 1987).

b.
DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48
CHAPTER 3) CLAUSES:

 
1.
HHSAR Clause 352.223-70, Safety and Health (January 2006)

 
2.
HHSAR Clause 352.224-70, Privacy Act (January 2006).

 
3.
HHSAR Clause 352.201-70, Paperwork Reduction Act (January 2006).

 
37

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4.
HHSAR Clause 352.270-4, Protection of Human Subjects (January 2006).

ARTICLE I.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT

This contract incorporates the following clauses in full text.
FEDERAL ACQUISITION REGULATION (FAR)(48 CFR CHAPTER 1)CLAUSES:
 
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 the
Contractor within 60 days after the government has completed its analysis of the
deliverables associated with the applicable GO/NO GO criteria (See Attachment 6)
and at least 30 days prior to the expiration date of the Period of Performance
(PoP) applicable to the base work segment or the PoP applicable to any option
segment; provided that the Government gives the Contractor a preliminary written
notice of its intent to extend performance at least 30 days prior to the
expiration date of the Period of Performance (PoP) applicable to the base work
segment or the PoP applicable to any option segment.  The preliminary notice
does not commit the Government to an extension.
(b) If the Government exercises this option, the extended contract shall be
considered to include this option clause.
(c) The total duration of this contract, including the exercise of any options
under this clause, shall not exceed 5 years

FAR Clause 52.219-28, Post-Award Small Business Program Representation (April
2009).

(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 52.217-8, Option
to Extend Services, 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 in
which it is bidding on Government contracts, and qualified as a small business
under the criteria in 13 CFR part 121 and the size standard in paragraph (c) of
this clause.  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 business activity 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 of business activity.

(b)  If the Contractor represented that it was a small business concern prior to
award of this contract, the Contractor shall represent its size status according
to paragraph (e) of this clause or, if applicable, paragraph (g) of this clause,
upon the occurrence of any of the following:

 
38

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(1)
Within 30 days after execution of a novation agreement or within 30 days after
modification of the contract to include this clause, if the novation agreement
was executed prior to inclusion of this clause in the contract.

 
(2)
Within 30 days after a merger or acquisition that does not require a novation or
within 30 days after modification of the contract to include this clause, if the
merger or acquisition occurred prior to inclusion of this clause in the
contract.

 
(3)
For long-term contracts—

 
(i).
Within 60 to 120 days prior to the end of the fifth year of the contract; and

 
(ii).
Within 60 to 120 days prior to the date specified in the contract for 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 found at
http://www.sba.gov/contractingopportunities/officials/size/index.html .

(d) The small business size standard for a Contractor providing a product which
it does 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
make the 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, to ensure 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 the actions required by paragraphs (e) or (g) of this clause.

(g)  If the Contractor does not have representations and certifications in ORCA,
or does not have a representation in ORCA for the NAICS code applicable to this
contract, the Contractor is required to complete the following representation
and submit 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, o is not a small business concern under
NAICS Code assigned to contract number.

[Contractor to sign and date and insert authorized signer's name and title].

(End of clause)

 
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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/WBS

Statement of Work, dated 12/09/2010 (33 pages)

2.      Risk Management Plan/Matrix

Risk Management Plan dated 11/23/2010 (9 pages)/Matrix dated 11/23/2010(12
pages)

3.      Invoice/Financing Request Instructions for AMCG Cost-Reimbursement Type
Contracts

Invoice/Financing Request Instructions for AMCG Cost-Reimbursement Type
Contracts (5 pages)

4.      Instructions for Completing Financial Report of Individual
Project/Contract

Instructions for Completing Financial Report of Individual Project/Contract (5
pages)

5.      Earned Value Management (EVM) Requirements

Instructions for Earned Value Management (EVM) Requirements (9 pages)

6.      Summary of Aeolus Tasks by Period

WBS Milestones and Deliverables and Technical Deliverables Chart with GO/NO-GO
Criteria (5 pages)

 
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PART IV – REPRESENTATIONS AND INSTRUCTIONS

SECTION K – REPRESENTATIONS AND CERTIFICATIONS

The following documents are incorporated by reference in this contract:

1.
Annual Representations and Certifications completed and located at the Online
Representations and Certifications Application (ORCA) website

 
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Advanced Development of a AEOL10150 as a Medical Countermeasure
for Pulmonary Injury Associated with ARS and DEARE
[ex10-1logo.jpg]

Statement of Work
 
Preface
 
Independently and not as an agent 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 the Statement of Work submitted in response to Broad Agency
Announcement (BAA) BARDA 09-34 in addition to Amendment 4 Special Instructions.
The Government reserves the right to modify the milestones, progress, schedule,
budget, or product to add or delete products, process, or schedule as need may
arise. Because of the nature of this (R&D) contract and complexities inherent in
this and prior programs, at designated milestones the government will evaluate
whether work should be redirected, removed, or whether schedule or budget
adjustments should be made. In any event, the Government reserves the right to
change product, process, schedule, or event to add or delete part or all of
these elements as the need arises.
 
Overall Scope & Objectives of the Effort
 
As proposed herein Aeolus Pharmaceuticals intends to complete the necessary
steps required to obtain FDA product approval for AEOL 10150, a broad-spectrum
catalytic antioxidant, for treatment of the ARS/DEARE pulmonary sub-syndrome.
These steps include a key study with acceptable efficacy parameters for AEOL
10150 treatment in two animal models (mouse and NHP) relevant to the human
radiation response and its treatment, demonstration of the safety of AEOL 10150
in humans, determination of relevant dosing and administration of AEOL 10150 in
humans, and identification of the mechanism of radiation-induced damage to the
lung and its amelioration by AEOL 10150.
 
Development Approach
 
The ability of a drug to ameliorate radiation lethality cannot be tested in
humans. The “Animal Rule” provides a means to evaluating the safety and
potential efficacy of such a drug in humans. The “Animal Rule” contains four
pillars:
 
1.
There is a reasonably well understood pathophysiological mechanism for the
toxicity of the chemical, biological, radiological or nuclear substance and its
amelioration or prevention by the product.

 
2.
The effect is demonstrated in more than one animal species expected to react
with a response predictive for humans, unless the effect is demonstrated in a
single species that represents a sufficiently well-characterized animal model
(meaning the model has been adequately evaluated for its responsiveness) for
predicting the response in humans.

 
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3.
The animal study endpoint is clearly related to the desired benefit in humans,
which is generally the enhancement of survival or prevention of major morbidity.

 
4.
The data or information on the pharmacokinetics and pharmacodynamics of the
product or other relevant data or information in animals and humans is
sufficiently well understood to allow selection of an effective dose in humans,
and it is therefore reasonable to expect the effectiveness of the product in
animals to be a reliable indicator of its effectiveness in humans.

 
[…***…]

*Confidential Treatment Requested

 
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[…***…]

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[…***…]

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[…***…]

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[…***…]

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[…***…]

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[…***…]

*Confidential Treatment Requested
 

 
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Risk Management Plan

Table of Contents
1 Introduction
1
1.1 Purpose
2
2 Risk Management Strategy
2
2.1 Risk Identification
2
2.2 Risk Responsibilities
4
2.3 Risk Assessment
4
2.4 Risk Response
6
2.5 Risk Mitigation
7
2.6 Risk Contingency Planning
7
2.7 Tracking and Reporting
8
2.8 Processes to Address Immediate Unforeseen Risks
8

 
 
 

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1 Risk Management Strategy - Introduction
Aeolus will incorporate quality assurance and risk evaluation into all aspects
of the work performed under this contract. The project management approach
described in this section establishes an integrated Risk management Process that
provides oversight by a team of experienced professionals who are capable of
anticipating risks associated with project execution, regulatory affairs, and
technology issues.  Via the management approach described, the team will
evaluate risk and quality assurance methodologies on an ongoing basis to
anticipate risk prior to escalation to an issue and implementing risk mitigation
strategies to address risks preemptively. The overall goal of Aeolus's risk and
quality management strategy is to eliminate to the extent possible all risk
associated with the project and assure quality throughout the projects execution
as required by the applicable guidelines and regulations (e.g., GCP, GMP, GLP).

Risk management is an ongoing process that continues through the life of a
project. It includes processes for risk management planning, identification,
analysis, monitoring and control. Many of these processes are updated throughout
the project lifecycle as new risks can be identified at any time. It’s the
objective of risk management to decrease the probability and impact of events
adverse to the project. On the other hand, any event that could have a positive
impact should be exploited.

The identification of risk starts before the project is initiated, and the
number of risks increase as the project matures through the lifecycle. When a
risk is identified, it’s first assessed to ascertain the probability of
occurring, the degree of impact to the schedule, scope, cost, and quality, and
then prioritized. Some risk events may impact only one item or task in a
project, while others may impact the project in multiple impact categories. The
probability of occurrence, number of categories impacted and the degree to which
they impact the project will be the basis for assigning the risk priority. All
identifiable risks will be entered into a risk register, and documented as a
risk statement.

As part of documenting a risk, two other important items need to be
addressed.  The first is mitigation steps that can be taken to lessen the
probability of the event occurring. The second is a contingency plan, or a
series of activities that should take place either prior to, or when the event
occurs. Mitigation actions frequently have a cost. Sometimes the cost of
mitigating the risk can exceed the cost of assuming the risk and incurring the
consequences. It is important to evaluate the probability and impact of each
risk against the mitigation strategy cost before deciding to implement a
contingency plan. Contingency plans implemented prior to the risk occurring are
pre-emptive actions intended to reduce the impact or remove the risk in its
entirety. Contingency plans implemented after a risk occurs can usually only
lessen the impact.

Identifying and documenting events that pose a risk to the outcome of a project
is just the first step. It is equally important to have a risk management team
monitor all risks on a scheduled basis and report on them in the project status
report.

 
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1.1 Purpose
This plan documents the processes, tools and procedures that will be used to
manage and control those events that could have a negative impact on the
Advanced Development of AEOL 10150 as a Medical Countermeasure for Pulmonary
Injury Associated with ARS and DEARE. It’s the controlling document for managing
and controlling all project risks. This plan will address:
• Risk Identification
• Risk Assessment
• Risk Mitigation
• Risk Contingency Planning
• Risk Tracking and Reporting

Appendix A will present the risk impact assessment matrix and appendix B will
present a sample of the risk register.

2 Risk Management Strategy
2.1 Risk Identification
A risk is any event that could prevent the project from progressing as planned,
or from successful completion. Risks can be identified from a number of
different sources. Some may be quite obvious and will be identified prior to
project kickoff.  Others will be identified during the project lifecycle, and a
risk can be identified by anyone associated with the project. Some risk will be
inherent to the project itself, while others will be the result of external
influences that are completely outside the control of the project team.

The Advanced Development of AEOL 10150 as a Medical Countermeasure for Pulmonary
Injury Associated with ARS and DEARE Project Manager, […***…], has overall
responsibility for managing project risk.  Project team members may be assigned
specific areas of responsibility for reporting to the project manager.

Throughout all phases of the project, a specific topic of discussion will be
risk identification. The intent is to instruct the project team in the need for
risk awareness, identification, documentation and communication.

Risk awareness requires that every project team member be aware of what
constitutes a risk to the project, and being sensitive to specific events or
factors that could potentially impact the project in a positive or negative way.

Risk identification consists of determining which risks are likely to affect the
project and documenting the characteristics of each.

Risk communication involves bringing risk factors or events to the attention of
the project manager and project team.
 
*Confidential Treatment Requested
 
 
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The Advanced Development of AEOL 10150 as a Medical Countermeasure for Pulmonary
Injury Associated with ARS and DEARE project manager will identify and document
known risk factors during creation of the Risk Register.

It is the Advanced Development of AEOL 10150 as a Medical Countermeasure for
Pulmonary Injury Associated with ARS and DEARE project manager’s responsibility
to assist the project team and other stakeholders with risk identification, and
to document the known and potential risks in the Risk Register. Updates to the
risk register will occur as risk factors change. Risk management will be a topic
of discussion during the regularly scheduled project meetings.

The Advanced Development of AEOL 10150 as a Medical Countermeasure for Pulmonary
Injury Associated with ARS and DEARE project team will discuss any new risk
factors or events, and these will be reviewed with the project manager.  The
project manager will determine if any of the newly identified risk factors or
events warrants further evaluation. Those that do will undergo risk
quantification and risk response development, as appropriate, and the action
item will be closed.

At any time during the project, any risk factors or events should be brought to
the attention of the Advanced Development of AEOL 10150 as a Medical
Countermeasure for Pulmonary Injury Associated with ARS and DEARE project
manager using Email or some other form of written communication to document the
item. The project manager is responsible for logging the risk to the Risk
Register. Notification of a new risk should include the following Risk Register
elements:

• Description of the risk factor or event (e.g. conflicting project or
operational initiatives that place demands on project resources, unexpected
study outcomes, delays, etc.)
• Probability that the event will occur (e.g. a 50% chance that the vendor will
not have an animal colony that meets the criteria available)
• Schedule Impact - the number of hours, days, week, or months that a risk
factor could impact the schedule (e.g. the animals require an additional 3
months to meet age requirements).
• Scope Impact - the impact the risk will have on the envisioned accomplishments
of the project. Delayed animal delivery may result in a reduction in the number
of studies that can be completed within the contract period of performance.
• Quality Impact - a risk event may result in a reduction in the quality of work
or products that are developed. (e.g. lack of funding caused by cost overruns
may result in the reduction of the study size and impact statistical
empowerment)
• Cost Impact - the impact the risk event, if it occurs is likely to have on the
project budget.

 
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2.2 Risk Responsibilities
The responsibility for managing risk is shared amongst all the stakeholders of
the project. However, decision authority for selecting whether to proceed with
mitigation strategies and implement contingency actions, especially those that
have an associated cost or resource requirement rest with the Project Manager
who is responsible for informing the funding agency to determine the requirement
for a contract modification. The following tables details specific
responsibilities for the different aspects of risk management.
Risk Identification: All project stakeholders
Risk Registry: Project Manager
Risk Assessment: All project stakeholders
Risk Response Options Identification: All project stakeholders
Risk Response Approval: PM with concurrence from CO/PO/COTR
Risk Contingency Planning: Project Manager
Risk Response Management: Project Manager
Risk Reporting: Project Manager

2.3 Risk Assessment
Risk assessment is the act of determining the probability that a risk will occur
and the impact that event would have, should it occur. This is basically a
“cause and effect” analysis. The “cause” is the event that might occur, while
the “effect” is the potential impact to a project, should the event occur.

Assessment of a risk involves two factors. First is the probability which is the
measure of certainty that an event, or risk, will occur. This can be measured in
a number of ways, but for the Advanced Development of AEOL 10150 as a Medical
Countermeasure for Pulmonary Injury Associated with ARS and DEARE project will
be assigned a probability as defined in the table below.

Probability of Occurrences
Definition
 
Meaning
 
Value
Nearly Certain
 
·     Certain to occur
·     Will be continuously experienced unless action is taken to change events
 
5
Highly Likely
 
·     Highly likely to occur
·     Issues identified with minimal audit activity
·     Process performance failures evident to trained auditors or regulators
 
4
Likely
 
·     Occurs sporadically
·     Potential issues discovered during focused review.
 
3
Unlikely
 
·     Unlikely to occur
·     Minimal issue identification during focused review
 
2
Improbable
 
·     Highly unlikely to occur
  
1

The second factor is estimate of the impact on the project. This can be a
somewhat subjective assessment, but should be quantified whenever possible. The
estimated cost, the duration of the potential delay, the changes in scope and
the reduction in quality are in most cases factors that can be estimated and
documented in the risk statement and then measured using the standard project
management tools (i.e. project plan, budget, statements of work). Rather than
detailed impact estimates the Risk Register contains five ratings for impact;

 
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Catastrophic (A)
Regulatory/Compliance violations/issues
Inability to validate data
Withdrawal of product manufacturer
Tainted product
Materials breech
Production delays
Technical miscommunications
Security/confidentiality breeches

Critical (B)
A non-compliance finding resulting in process, or operational degradation
A security finding requiring immediate corrective action prior to continued
operation
Reoccurring violation of any safety regulation resulting in serious injury
Production errors containing regulatory violations that pose direct consequence
to the operation

Moderate (C)
Security finding requiring a Corrective Action Plan
Production element errors that may pose indirect consequences to the operation

Minor (D)
No regulatory action anticipated
No compliance impact anticipated
No evident security threat affected
Minor errors in completed Company policy & procedures
Production errors containing quality system and / or opportunities for
improvement

Negligible (E)
No regulatory/compliance violation
No security/confidentiality element affected
On time production
Validated experiments
“Clean” product
Properly executed communications

For each of the impact categories the impact assessment should include
consideration of the following areas of impact also:

 
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• Cost – This impact is usually estimated as a dollar amount that has a direct
impact to the project. However, cost is sometimes estimated and reported as
simply additional resources, equipment, etc. This is true whenever these
additional resources will not result in a direct financial impact to the project
due to the fact the resources are loaned or volunteer, the equipment is
currently idle and there is no cost of use, or there are other types of
donations that won’t impact the project budget. Regardless of whether there is a
direct cost, the additional resources should be documented in the risk statement
as part of the mitigation cost.
• Scope – Whenever there is the potential that the final product will not be
completed as originally envisioned there is a scope impact. Scope impact could
be measured as a reduction of the number of studies completed, or not providing
a deliverable such as an IND.
• Schedule – It is very important to estimate the schedule impact of a risk
event as this often results is the basis for elevating the other impact
categories. Schedule delays frequently result in cost increases and may result
in a reduction of scope or quality. Schedule delays may or may not impact the
critical path of the project and an associated push out of the final end date.
• Performance/Quality – Performance/Quality is frequently overlooked as an
impact category and too often a reduction in quality is the preferred choice for
mitigation of a risk. “Short cuts” and “low cost replacements” are ways of
reducing cost impacts. If not documented appropriately and approved by the
project sponsor, mitigation strategies that rely upon a reduction in quality can
result in significant disappointment by the stakeholders.

Most risks will be assigned one category, but some might be assigned more than
one, or all.

2.4 Risk Response
For each identified risk, a response must be identified. It is the
responsibility of the project team to select a risk response for each risk. The
project team will need the best possible assessment of the risk and description
of the response options in order to select the right response for each risk. The
probability of the risk event occurring and the impacts will be the basis for
determining the degree to which the actions to mitigate the risk should be
taken. One way of evaluating mitigation strategies is to multiply the risk cost
times the probability of occurrence. Mitigation strategies that cost less than
risk probability calculation should be given serious consideration. The possible
response options are:
• Avoidance – Change the project to avoid the risk. Change scope, objectives,
etc.
• Transference – Shift the impact of a risk to a third party (like a
subcontractor). It does not eliminate it, it simply shifts responsibility.
• Mitigation – Take steps to reduce the probability and/or impact of a risk.
Taking early action, close monitoring, more testing, etc.
• Acceptance – Simply accept that this is a risk. When choosing acceptance as a
response the IMPD is stating that given the probability of occurring and the
associated impact to the project that results, they are not going to take any
actions and will accept the cost, schedule, scope, and quality impacts if the
risk event occurs.
• Deferred – A determination of how to address this risk will be addressed at a
later time. The results of the risk assessment process are documented in each
Risk Statement and summarized in the Risk Register which will be reported on a
monthly basis.
 
 
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2.5 Risk Mitigation
Risk mitigation involves two steps:
• Identifying the various activities, or steps, to reduce the probability and/or
impact of an adverse risk.
• Creation of a Contingency Plan to deal with the risk should it occur.

Taking early steps to reduce the probability of an adverse risk occurring may be
more effective and less costly than repairing the damage after a risk has
occurred. However, some risk mitigation options may simply be too costly in time
or money to consider.

Mitigation activities should be documented in the Risk Register, and reviewed on
a regular basis. They include:
• Identification of potential failure points for each risk mitigation solution.
• For each failure point, document the event that would raise a “flag”
indicating that the event or factor has occurred or reached a critical
condition.
• For each failure point, provide alternatives for correcting the failure.

2.6 Risk Contingency Planning
Contingency planning is the act of preparing a plan, or a series of activities,
should an adverse risk occur. Having a contingency plan in place forces the
project team to think in advance as to a course of action if a risk event takes
place.
• Identify the contingency plan tasks (or steps) that can be performed to
implement the mitigation strategy.
• Identify the necessary resources such as money, equipment and labor.
• Develop a contingency plan schedule. Since the date the plan will be
implemented is unknown, this schedule will be in the format of day 1, day 2, day
3, etc., rather than containing specific start and end dates.
• Define emergency notification and escalation procedures, if appropriate.
• Develop contingency plan training materials, if appropriate.
• Review and update contingency plans if necessary.
• Publish the plan(s) and distribute the plan(s) to management and those
directly involved in executing the plan(s).

Contingency may also be reflected in the project budget, as a line item to cover
unexpected expenses. The amount to budget for contingency may be limited to just
the high probability risks. This is normally determined by estimating the cost
if a risk occurs, and multiplying it by the probability. For example, assume a
risk is estimated to result in an additional cost of $50,000, and the
probability of occurring is 80%. The amount that should be included in the
budget for this one item is $40,000.
 
 
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Associated with a contingency plan, are start triggers and stop triggers. A
start trigger is an event that would activate the contingency plan, while a stop
trigger is the criteria to resume normal operations. Both should be identified
in the Risk Register and can be embedded, example; the stop trigger can be
included in the contingency plan field.

2.7 Tracking and Reporting
As project activities are conducted and completed, risk factors and events will
be monitored to determine if in fact trigger events have occurred that would
indicate the risk is now a reality.

Based on trigger events that have been documented during the risk analysis and
mitigation processes, the project team or project managers will have the
authority to enact contingency plans as deemed appropriate. Day to day risk
mitigation activities will be enacted and directed by the project managers.

Contingency plans that once approved and initiated will be added to the project
work plan and be tracked and reported along with all of the other project
activities.

Risk management is an ongoing activity that will continue throughout the life of
the project. This process includes continued activities of risk identification,
risk assessment, planning for newly identified risks, monitoring trigger
conditions and contingency plans, and risk reporting on a regular basis. Project
status reporting contains a section on risk management, where new risks are
presented along with any status changes of existing risks. Some risk attributes,
such as probability and impact, could change during the life of a project and
this should be reported as well.

2.8 Processes to Address Immediate Unforeseen Risks
The individual identifying the risk will immediately notify the project
managers. The individual notified will assess the risk situation.

If required, the project managers will identify a mitigating strategy, and
assign resources as necessary.

The project risk manager will document the risk factor and the mitigating
strategy.
 
 
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Appendix A – Risk Assessment Matrix

Probability of Occurrences
 
Catastrophic
 
Critical
 
Moderate
 
Minor
 
Negligible
Definition
 
Meaning
 
Value
 
(A)
 
(B)
 
(C)
 
(D)
 
(E)
Nearly Certain
 
·     Certain to occur
·     Will be continuously experienced unless action is taken to change events
 
5
 
5A
 
5B
 
5C
 
5D
 
5E
Highly Likely
 
·     Highly likely to occur
·     Issues identified with minimal audit activity
·     Process performance failures evident to trained auditors or regulators
 
4
 
4A
 
4B
 
4C
 
4D
 
4E
Likely
 
·     Likely to Occur sporadically
·     Potential issues discovered during focused review
 
3
 
3A
 
3B
 
3C
 
3D
 
3E
Unlikely
 
·     Unlikely to occur
·     Minimal issue identification during focused review
 
2
 
2A
 
2B
 
2C
 
2D
 
2E
Improbable
  
·     Highly unlikely to occur
  
1
 
1A
  
1B
  
1C
  
1D
  
1E

 
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Appendix B – Risk Register for Advanced Development of AEOL 10150 as a MCM for
ARS & DEARE Pulmonary Injury

[…***…]

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14

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Advanced Development of a AEOL10150 as a Medical Countermeasure
for Pulmonary Injury Associated with ARS and DEARE
[ex10-1logo.jpg]

 
[…***…]

*Confidential Treatment Requested

 
15

--------------------------------------------------------------------------------

 
 
Advanced Development of a AEOL10150 as a Medical Countermeasure
for Pulmonary Injury Associated with ARS and DEARE
[ex10-1logo.jpg]

 
[…***…]
 
*Confidential Treatment Requested

 
16

--------------------------------------------------------------------------------

 
 
Advanced Development of a AEOL10150 as a Medical Countermeasure
for Pulmonary Injury Associated with ARS and DEARE
[ex10-1logo.jpg]

 
[…***…]
 
*Confidential Treatment Requested

 
17

--------------------------------------------------------------------------------

 
 
Advanced Development of a AEOL10150 as a Medical Countermeasure
for Pulmonary Injury Associated with ARS and DEARE
[ex10-1logo.jpg]

 
[…***…]
 
*Confidential Treatment Requested

 
18

--------------------------------------------------------------------------------

 

Advanced Development of a AEOL10150 as a Medical Countermeasure
for Pulmonary Injury Associated with ARS and DEARE
[ex10-1logo.jpg]

 
[…***…]

*Confidential Treatment Requested
 
 
19

--------------------------------------------------------------------------------

 

Advanced Development of a AEOL10150 as a Medical Countermeasure
for Pulmonary Injury Associated with ARS and DEARE
[ex10-1logo.jpg]

 
[…***…]

*Confidential Treatment Requested

 
20

--------------------------------------------------------------------------------

 
 
ATTACHMENT 3

INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORTING
INSTRUCTIONS FOR BARDA COST-REIMBURSEMENT CONTRACTS

Format:  Payment requests shall be submitted on the Contractor’s self-generated
form in the manner and format prescribed herein and as illustrated in the Sample
Invoice/Financing Request.  Standard Form 1034, Public Voucher for Purchases and
Services Other Than Personal, may be used in lieu of the Contractor’s
self-generated form provided it contains all of the information 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 G of the Contract Schedule.

Frequency:  Payment requests shall not be submitted more frequently than once
every two weeks in accordance with the Allowable Cost and Payment Clause
incorporated into this contract.  Small business concerns may submit
invoices/financing requests more frequently than every two weeks when authorized
by the Contracting Officer.

Cost Incurrence Period:  Costs incurred must be within the contract performance
period or covered by precontract 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
site 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 BARDA contracts are expressed in United States dollars.  When the
Government pays in a currency other than United States 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 the completion 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 and the 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 G of the Contract Schedule.

(b)
Contractor's Name, Address, Point of Contact, VIN, and DUNS or DUNS+4
Number:  Show the Contractor's name and 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 and address exactly as stated on the face page of
the contract.  When an approved assignment has been made by the Contractor, or a
different payee has been designated, provide the same information for the payee
as is required for the Contractor (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 billing under an order, insert the total
estimated cost of the order, exclusive of fixed-fee.  For incrementally funded
contracts/orders, enter the amount currently obligated and available for
payment.

(h)
Total Fixed-Fee:  Insert the total fixed-fee (where applicable).  For
incrementally funded contracts/orders, enter the amount currently obligated and
available for payment.

(i)
Two-Way/Three-Way Match:  Identify whether payment is to be made using a two-way
or three-way match.  To determine required payment method, refer to the Invoice
Submission Instructions in Section G of the Contract Schedule.

(j)
Office of Acquisitions:  Insert the name of the Office of Acquisitions, as
identified in the Invoice Submission Instructions 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 incurred and 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 the contract 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 the
payment 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)
Department Labor:  Department Costs – List department number, hours,
departmental labor rate, and amount claimed.

 
(2)
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 is requested.  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 specific limitations set forth in the contract.

 
(4)
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.

 
(5)
Premium Pay:  List remuneration in excess of the basic hourly rate.

 
(6)
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.

 
(7)
Travel:  Include domestic and foreign travel.  Foreign travel is travel outside
of the United States and its territories and possessions.  However, for an
organization located outside of the United States and its territories and
possessions, foreign travel means travel outside that country.  Foreign travel
must be billed separately from domestic travel.

 
(8)
Subcontract Costs:  List subcontractor(s) by name and amount billed.

 
(9)
Other:  List all other direct costs in total unless exceeding $1,000 in
amount.  If over $1,000, list cost elements and dollar 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 as provided 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 to appeal.

(u) 
Grand Totals

(v)
Certification of Salary Rate Limitation:  If required by the contract (see
Invoice Submission Instructions in Section G of 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.”

The Contracting Officer may require the Contractor to submit detailed support
for costs claimed on one or more interim 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 by each 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 will vary 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) and negotiated costs (Column G) when entries have
been made in Column F.  This column need not be filled in when Column F is
blank.  When a line item varies by plus or minus 10 percent, i.e., the
percentage arrived at by dividing Column F by Column G, an explanation of the
variance should be submitted.  In the case of an overrun (net negative
variance), this submission shall not 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 the appropriate cost category.

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

 
 

--------------------------------------------------------------------------------

 
 
SAMPLE INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORT
(a)     Designated Billing Office Name and Address:
 
DHHS/OS/ASPR/BARDA
Attn: Contracting Officer
330 Independence Ave., S.W.
Room G644
Washington, D.C. 20201
 
(b)     Contractor’s Name, Address, Point of Contact, VIN, and DUNS or DUNS+4
Number:
 
ABC CORPORATION
100 Main Street
Anywhere, USA  Zip Code
 
Name, Title, Phone Number, and E-mail Address  of person to notify in the event
of an improper invoice or, in the case of payment by method other than
Electronic Funds Transfer, to whom payment is to be sent.
 
VIN:  
DUNS or DUNS+4:
(c)     Invoice/Financing Request No.:  
 
(d)     Date Invoice Prepared:  
 
(e)     Contract No. and Order No. (if applicable): ________
 
(f)     Effective Date:  
 
(g)     Total Estimated Cost of Contract/Order:  
 
(h)     Total Fixed-Fee (if applicable):  
(i)     ¨Two-Way Match:
   ¨Three-Way Match:  
(j)     Office of Acquisitions:  
 
(k)     Central Point of Distribution:  

(l) This invoice/financing request represents reimbursable costs for the period
from                   to

   
Cumulative Percentage of 
Effort/Hrs.
 
Amount Billed
           
Expenditure Category*
A
 
Negotiated
B
 
Actual
C
 
(m)
Current
D
 
(n) Cumulative
E
 
Cost at 
Completion
F
 
Contract
Amount
G
 
Variance
H
(o) Direct Costs:
                           
(1)  Direct Labor
                           
(2)  Fringe Benefits
                           
(3)  Accountable Property
                           
(4)  Materials & Supplies
                           
(5)  Premium Pay
                           
(6)  Consultant Fees
                           
(7)  Travel
                           
(8)  Subcontracts
                           
(9)  Other
                           
Total Direct Costs
                           
(p) Cost of Money
                           
(q) Indirect Costs
                           
(r) Fixed Fee
                           
(s) Total Amount Claimed
                           
(t) Adjustments
                           
(u) Grand Totals
         
  
 
  
 
  
 
  
 
  

I certify that all payments are for appropriate purposes and in accordance with
the contract.

           
(Name of Official)
 
(Title)
 

* Attach details as specified in the contract

 
 

--------------------------------------------------------------------------------

 

ATTACHMENT 4
INSTRUCTIONS FOR COMPLETING
"FINANCIAL REPORT OF INDIVIDUAL PROJECT/CONTRACT"

GENERAL INFORMATION

Purpose.  This Quarterly Financial Report is designed to:  (1) provide a
management tool for use by be BARDA in monitoring the application of financial
and personnel resources to the BARDA contracts; (2) provide contractors with
financial and personnel management data which is usable in their management
processes; (3) promptly indicate potential areas of contract underruns or
overruns by making possible comparisons of actual performance and projections
with prior estimates on individual elements of cost and personnel; and (4)
obtain contractor's analyses of cause and effect of significant variations
between actual and prior estimates of financial and personnel performance.

REPORTING REQUIREMENTS

Scope.  The specific cost and personnel elements to be reported shall be
established by mutual agreement prior to award.  The Government may require the
contractor to provide detailed documentation to support any element(s) on one or
more financial reports.

Number of Copies and Mailing Address.  An original and two (2) copies of the
report(s) shall be sent to the contracting officer at the address shown on the
face page of the contract, no later than 30 working days after the end of the
period reported.  However, the contract may provide for one of the copies to be
sent directly to the Contracting Officer’s Technical Representative.

REPORTING STATISTICS

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

Definitions and Instructions for Completing the Quarterly Report.  For the
purpose of establishing expenditure categories in Column A, the following
definitions and instructions will be utilized.  Each contract will specify the
categories to be reported.

(1)
Departmental Labor.  List as one amount unless otherwise required by the
contract.

(2)
Accountable Personal Property.  Include nonexpendable personal property with an
acquisition cost of $1,000 or more and with an expected useful life of two or
more years, and sensitive items regardless of cost.  Form HHS 565, "Report of
Accountable Property," must accompany the contractor's public voucher (SF
1034/SF 1035) or this report if not previously submitted.  See "Contractor's
Guide for Control of Government Property."

(3)
Supplies.  Include the cost of supplies and material and equipment charged
directly to the contract, but excludes the cost of nonexpendable equipment as
defined in (4) above.

(4)
Inpatient Care.  Include costs associated with a subject while occupying a bed
in a patient care setting.  It normally includes both routine and ancillary
costs.

(5)
Outpatient Care.  Include costs associated with a subject while not occupying a
bed.  It normally includes ancillary costs only.

(6)
Travel.  Include all direct costs of travel, including transportation,
subsistence and miscellaneous expenses.  Travel for staff and consultants shall
be shown separately.  Identify foreign and domestic travel separately.  If
required by the contract, the following information shall be submitted: (i) Name
of traveler and purpose of trip; (ii) Place of departure, destination and
return, including time and dates; and (iii) Total cost of trip.

(7)
Consultant Fee.  Include fees paid to consultant(s).  Identify each consultant
with effort expended, billing rate, and amount billed.

(8)
Premium Pay.  Include the amount of salaries and wages over and above the basic
rate of pay.

(9)
Subcontracts.  List each subcontract by name and amount billed.

 
 

--------------------------------------------------------------------------------

 

(10)
Other Costs.  Include any expenditure categories for which the Government does
not require individual line item reporting.  It may include some of the above
categories.

(11)
Overhead/Indirect Costs.  Identify the cost base, indirect cost rate, and amount
billed for each indirect cost category.

(12)
General and Administrative Expense.  Cite the rate and the base.  In the case of
nonprofit organizations, this item will usually be included in the indirect
cost.

(13)
Fee.  Cite the fee earned, if any.

(14)
Total Costs to the Government.

PREPARATION INSTRUCTIONS

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

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

Column B—Percentage of Effort/Hours Negotiated.  Enter the percentage of effort
or number of hours agreed to during contract negotiations for each labor
category listed in Column A.

Column C—Percentage of Effort/Hours-Actual.  Enter the cumulative percentage of
effort or number of hours worked by each employee or group of employees listed
in Column A.

Column D—Cumulative Incurred Cost at End of Prior Period.  Enter the cumulative
incurred costs up to the end of the prior reporting period.  This column will be
blank at the time of the submission of the initial report.

Column E—Incurred Cost-Current Period.  Enter the costs which were incurred
during the current period.

Column F—Cumulative Incurred Cost to Date.  Enter the combined total of Columns
D and E.

Column G—Estimated Cost to Complete.  Make entries only when the contractor
estimates that a particular expenditure category will vary from the amount
negotiated.  Realistic estimates are essential.

Column H—Estimated Costs at Completion.  Complete only if an entry is made in
Column G.

Column I—Negotiated Contract Amount.  Enter in this column the costs agreed to
during contract negotiations for all expenditure categories listed in Column A.

Column J—Variance (Over or Under).  Complete only if an entry is made in Column
H.  When entries have been made in Column H, this column should show the
difference between the estimated costs at completion (Column H) and negotiated
costs (Column I).  When a line item varies by plus or minus 10 percent, i.e.,
the percentage arrived at by dividing Column J by Column I, an explanation of
the variance should be submitted.  In the case of an overrun (net negative
variance), this submission shall not be deemed as notice under the Limitation of
Cost (Funds) Clause of the contract.

Modifications.  List any modification in the amount negotiated for an item since
the preceding report in the appropriate cost category.

Expenditures Not Negotiated.  List any expenditure for an item for which no
amount was negotiated (e.g., at the discretion of the contractor in performance
of its contract) in the appropriate cost category and complete all columns
except for I.  Column J will of course show a 100 percent variance and will be
explained along with those identified under J above.

 
 

--------------------------------------------------------------------------------

 

 
FINANCIAL REPORT OF INDIVIDUAL
PROJECT/CONTRACT
 
Project Task:
Contract No.:
Date of Report:
0990-0134
0990-0131
Note:  Complete this Form in Accordance with
Accompanying Instructions.
Reporting Period:
 
Contractor Name and Address:

    
Percentage of
Effort/Hours
 
Cumulative
Incurred Cost
at End of Prior
 
Incurred
Cost–
Current
 
Cumulative
Cost to Date
 
Estimated
Cost to
 
Estimated Cost at
Completion
 
Negotiated
Contract
 
Variance (Over
or Under) (I -
Expenditure Category
 
Negotiated
 
Actual
 
Period
 
Period
 
(D + E)
 
Complete
 
(F + G)
 
Amount
 
H)
A
 
B
 
C
 
D
 
E
 
F
 
G
 
H
 
I
 
J
                                                                               
                                                                               
                                                                               
                                                                               
                                                                               
                                                                               
                                                                               
           
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 

 
 
3

--------------------------------------------------------------------------------

 
 

Earned Value Management (EVM) Requirements

The Contractor shall propose and provide a Performance Measurement System that
meets the Seven Principles of Earned Value Management.  The Seven Principles
are:
 
 
1.
Plan all work scope for the program to completion of the contract.

 
 
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 performance
measurement baseline plan against which accomplishments may be measured. Control
changes to the baseline.

 
 
4.
Use actual cost incurred and recorded in accomplishing the work performed.

 
 
5.
Objectively assess accomplishments at the work performance level.

 
 
6.
Analyze significant variances from the plan, forecast impacts, and prepare an
estimate at completion based on performance to date and work to be performed.

 

 
7.
Use Performance Based information in the company's management processes.

The Contractor shall develop a Work Breakdown Structure (WBS) to an appropriate
level and a WBS dictionary which lists and defines the WBS elements that also is
inclusive of the applicable EVM requirements.

Contractors required to provide Earned Value Management to their project can
obtain additional instruction from the 7 Principles of EVM Intent Guide.

The EVM requirements for this contract will be as follows:

Tier 2 – Contracts greater than $25M in total value (includes base and options)
and with a proposed product that has a Technology Readiness Level (TRL) of 6 or
greater.

 
 

--------------------------------------------------------------------------------

 

Deliverables

Performance Measurement Baseline Documentation

The Contractor shall submit a Performance Measurement Baseline Documentation
package for submission to BARDA within 90 days of contract award.  This document
package will include the following:

 
a)
Description of the work scope through Work Breakdown Structure Dictionary/Work
Authorization Documents at WBS Level 3;

 
b)
An Integrated Master Schedule (IMS) with the inclusion of agreed major
milestones;

 
c)
A control account plan (CAP) for all control accounts;

 
d)
Baseline revision documentation and program logs;

 
e)
And a risk register.

BARDA will review the documentation package and provide written comments
and  questions to the contractor or BARDA may set up a meeting to discuss open
issues.  Once final clarifications and responses have been exchanged, BARDA will
execute a formal approval of the Performance Measurement Baseline.

Earned Value Contract Performance Report (EV-CPR)

 
a)
The Contractor shall deliver an Earned Value Contract Performance Report
(EV-CPR) on monthly basis per the instruction in DI-MGMT-81466A (see
http://www.acq.osd.mil/pm/). Contractor shall provide preliminary EV-CPR, Format
1,on the 15th business day after end of Contractor reporting period and final
EV-CPR and Format 1 and Format 5 (VARs)  and a supplemental Control Account Plan
(CAP) report on the 20th business day after end of Contractor reporting period.
The variance narrative reports shall describe what the variance and indices may
be indicating regarding the over all performance, the reasons for the variances,
the adequacy of corrective action plans, and forecasts of future
performances.  The USG shall use best efforts to respond within 5 business days.

 
b)
The supplemental monthly CAP report shall contain, at the work package level,
time phased budget (budgeted cost of work scheduled (BCWS)), earned value
(budgeted cost of work performed (BCWP)) and actual costs of work performed
(ACWP) as captured in Contractor’s EVM systems.  The contractor shall provide a
rational in the package of its use of % complete as EVMS methodology or identity
if any other EVMS methodology is being used.

Integrated Master Schedule (IMS)

The Contractor shall deliver the Integrated Master Schedule (IMS) status with
performance data and should include actual start/finish and projected
start/finish dates.  The status schedule should be delivered 10 business days
after reporting month end. Contractor shall deliver a program level Integrated
Master Schedule that rolls up all time-phased WBS elements down to the activity
level. This IMS shall include the following fields at a minimum; baseline start
and finish, forecast start and finish; actual start and finish, predecessor
and/or successor. The Contractor shall deliver the Integrated master Schedule,
viewed at the work package level in MS Project file format

 
 

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Risk Register

The Contractor shall provide 90 days after contract award and quarterly or as
needed thereafter. The Contractor shall incorporate the work proposed to meet
the technical objectives (above) into the program risk register highlighting
potential problems and/or issues that may arise during the life of the contract,
their impact on cost, performance and timelines, and appropriate remediation
plans.

 
 

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GLOSSARY OF TERMS

Actual Cost of Work Performed (ACWP)
 
The costs actually applied and recorded in accomplishing the work performed
within a specified period.
     
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 and completed portions of
open Work Packages, plus the appropriate portion of the budgets for level of
effort and apportioned effort (Also see Earned Value).

 
 

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Control Account
 
A management control point at which actual costs can be accumulated 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 the work
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) Report
  
A CAP report is a timephased report which reflects all the work and effort to be
performed in a control account.  The CAP report will reflect the hours and
dollars by element of cost (labor, subcontract, ODC, etc).

 
 

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Contract Performance Report (CPR)
 
The monthly report submitted to the customer showing the current, cumulative and
at completion status, the performance measurement baseline, manpower loading,
and a narrative explanation of significant program variances.
     
Contract Target Cost
 
The dollar value (excluding fee or profit) negotiated in the original 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.
     
Earned Value
 
See Budgeted Cost for Work Performed (BCWP)
     
Earned Value Management System (EVMS)
  
A project management system utilized for measuring project progress in an
objective manner.  Combines measurements of scope, schedule, and cost in a
single integrated system.

 
 

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Estimate at Completion (EAC)
 
A value (expressed in dollars and/or hours) developed to represent a realistic
appraisal of the final cost of tasks when accomplished. It’s the sum of direct &
indirect costs to date plus 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 to represent a realistic
appraisal of the cost of the work still required to be accomplished in
completing a task.
     
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, and interdependencies required to complete the program.  The IMP and
IMS are used to track and execute the program.
     
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.

 
 

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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
allocation of overhead costs. For future effort, not planned to the Control
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.
     
Risk Register
 
Is a tool commonly used in project planning and organizational risk
assessments.  It is often referred to as a Risk Log.  It is used for
identifying, analyzing and managing risks.
     
Variance Analysis Report (VAR)
  
The internal report completed by the Control Account Manager and submitted,
through the Intermediate Manager, to the program manager for those Control
Accounts which have variances in excess of established thresholds.

 
 

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Work Authorization Document (WAD)
 
A form used to formally authorize and budget work to the Control Account
Manager. This document must include, as a minimum, the Control Account number,
Statement of Work, scheduled start and finish dates, budget, and the identity of
the CAM. It must be approved by Intermediate Manager, and be agreed to by the
Control Account Manager.

 
 
 

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