Exhibit 10.15

 

*Portions of this exhibit marked [*] are requested to be treated confidentially.
  OMB Approval 0990-0115      

 

AWARD/CONTRACT

 

 

1.  THIS CONTRACT IS A RATED ORDER UNDER DPAS (15 CFR 350)

  u  

RATING

 

PAGE    OF    PAGES

     

  N/A

 

1

     119   

2. CONTRACT (Proc. Inst. Indent.) NO.

 

3. EFFECTIVE DATE

 

4. REQUISITION/PURCHASE REQUEST/PROJECT NO.

HHSO100201300009C      See Block 20C.     OS111976    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

 

CEMPRA, Inc.

Building 4 Quadrangle

 

 

 

  See Schedule.

6340 Quadrangle Drive, Suite 100

Chapel Hill, NC 27517

 

 

 

9/ DISCOUNT FOR PROMPT PAYMENT

  N/A.

CAGE: 4D2L7                                TIN: 45-4440364  

10. SUBMIT INVOICES

 

  ITEM CODE DUNS No. 623713034   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

  Appropriation Year: 2013; Object Class:25106; CAN# 1992002  $17,710,427.25

   ¨  10 U.S.C. 2304(c)(    )               ¨  41 U.S.C. 253(c)(    )

 

      15A. ITEM NO.   15B. SUPPLIES/SERVICES       15C. UNIT PRICE    15D.
AMOUNT    15E. UNIT PRICE    15F. AMOUNT 

 

See Section B.

 

 

 

                                                        15G. TOTAL AMOUNT OF
CONTRACT             u   $17,710,427.25 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   57 x     B   SUPPLIES OR SERVICES AND
PRICE/COST   3       PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH. x
    C   DESCRIPTION / SPECS / WORK STATEMENT   11       x   J   LIST OF
ATTACHMENTS   63 x     D   PACKAGING AND MARKING   13       PART IV -
REPRESENTATIONS AND INSTRUCTIONS x     E   INSPECTION AND ACCEPTANCE   14      
x   K   REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS   64 x
    F   DELIVERIES OR PERFORMANCE   15             x     G   CONTRACT
ADMINISTRATION DATA   33       ¨   L   INSTRS., CONDS., AND NOTICES TO OFFERORS
    x     H   SPECIAL CONTRACT REQUIREMENTS   39       ¨   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   1    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.  ¨  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            

 

   Susan Cortes-Shrank   AMCG,  ASPR,  OS,  DHHS

 

 

 19B.  NAME OF CONTRACTOR   19C.  DATE SIGNED     20B.  UNITED STATES OF AMERICA
      20C. DATE SIGNED                  

 

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)  

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

CONTRACT TABLE OF CONTENTS

 

PART I – THE SCHEDULE

     3   

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

     3   

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

     11   

SECTION D - PACKAGING, MARKING AND SHIPPING

     13   

SECTION E - INSPECTION AND ACCEPTANCE

     14   

SECTION F - DELIVERIES OR PERFORMANCE

     15   

SECTION G - CONTRACT ADMINISTRATION DATA

     32   

SECTION H - SPECIAL CONTRACT REQUIREMENTS

     38   

PART II – CONTRACT CLAUSES

     56   

SECTION I - CONTRACT CLAUSES

     56   

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

     62   

SECTION J - LIST OF ATTACHMENTS

     62   

PART IV – REPRESENTATIONS AND INSTRUCTIONS

     63   

SECTION K – REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF OFFERORS

     63   

 

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 Solithromycin (CEM-101), a novel
fluoroketolide antibiotic of the macrolide class for the treatment of select
bacterial infections. The Research and Development (R&D) effort will progress in
specific stages that cover the base performance segment and four (4) option
segments as specified in this contract. Work performed during the base segment
and during each option segment constitutes an independent, non-severable
discrete work segment that cannot be subdivided for separate performance and is
necessary to support R&D tasks related to the antibiotic. Each non-severable,
work segment constitutes an entire job [discrete requirement] which shall
contain multiple R&D activities that when reviewed in total shall satisfy a
defined end-product. The non-severable, work segment will be fully funded from
an appropriation source that is current at the time the work will be authorized
to begin.

The government has determined a Bona Fide Need for each non-severable discrete
work segment which will conclude upon the completion of a defined task(s) that
provides independent merit and value to the Government. The Contractor must
achieve a defined end-product required in each discrete work segment, as
outlined in Article F of this contract, before the Government will consider
exercising any of the follow-on option segment(s). The Contractor’s success in
completing the required tasks under each work segment must be demonstrated
through the Deliverables and Milestones specified under Article F of this
contract. Those deliverables will support the GO/NO GO Contract Milestones and
Decision Gates specified therein. The GO/NO GO Contract Milestones and Decision
Gates will constitute the basis for the Government’s decision, at its sole
discretion, to exercise any follow-on option segment(s).

The base and option segments under Contract Line Items (CLINs) 0001 through 0005
are event driven work segments rather than time driven CLINs. The funds for each
independent, non-severable discrete work segment [requirement], regardless of
duration, are separated by CLIN, and shall only be used for the scope of work
covered in each discrete work segment (Attachment J). The periods of performance
listed under each of the CLINs under Article B.2 and Article B.3 below are
estimated time periods. Those individual time periods may be extended to
complete the tasks required under each work segment. It is possible that more
than one independent, non-severable discrete work segment [requirement], may be
awarded at one time and that individual CLINs may overlap and/or proceed
concurrently.

ARTICLE B.2. ESTIMATED COST AND FIXED FEE

 

  a. The total estimated cost of the base performance segment is $[*]

  b. The total fixed fee for the base performance segment is $[*]. The fixed fee
shall be paid subject to Allowable Cost and Payment and Fixed Fee Clauses.

  c. The total amount of the base performance segment, CLIN 0001, represented by
the sum of the total estimated cost plus fixed fee is $17,710,427.25. The
Government will not be responsible for any Contractor incurred costs that exceed
this amount unless a modification to the contract is signed by the Contracting
Officer which expressly increases this amount.

  d. It is estimated period of performance of the base performance segment is
through May 23, 2015.

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 

3

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  e. The Contractor shall maintain records of all contract costs and such
records shall be subject to the Audit and Records-Negotiation and Final
Decisions on Audit Findings clauses of the General Clauses.

 

CLIN    Estimated
Period of
Performance      Supplies/Services     Total Estimated  
Cost     Fixed Fee     

Total Estimated

Cost Plus

Fixed Fee

0001

   24 May 2013 through 23 May 2015.   

Toxicology studies, PK/PD modeling, safety studies, animal model efficacy
studies, select chemical synthesis activities

 

Reports and Other Data Deliverables.

    $[*]     $[*]   

$17,710,427.25

 

SOW Reference

1.2.2, 1.3.2, 1.4.1, 1.5.1, 1.5.2, 1.6.1, 1.6.2, 1.6.3, 1.6.5

ARTICLE B. 3. OPTION PRICES

 

  a. Unless the government exercises its option pursuant to the option clause
contained in ARTICLE I.2, the contract consists only of the Base Work segment
specified in the Statement of Work as defined in SECTONS C, for the price set
forth in ARTICLE B.2 of the contract.

  b. Pursuant to FAR Clause 52.217-9 (Option to Extend the Term of the
Contract), the Government may, by unilateral contract modification, require the
Contractor to perform the Option Work Segments specified in the Statement of
Work as defined in SECTIONS C and F of this contract. If the Government
exercises the/these option(s), written notice must be given to the Contractor
within 30 days after the Government has completed its analysis of the
deliverables associated with the applicable GO/NO GO Decision gate; and the
Government must give the Contractor a preliminary written notice of its intent
to exercise the option at least 30 days before the contract expires. 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) - CPFF

Option 2 (CLIN 0003) - CPFF

Option 3 (CLIN 0004) – Cost Share (Fee unallowable)

Option 4 (CLIN 0005) - CPFF

 

CLIN    Estimated
Period of
Performance      Supplies/Services  

  Total Estimated  

Cost

    Fixed Fee     

Total Estimated

Cost Plus

Fixed Fee

0002

  

24 May 2014 through 5

June 2016.

  

[*]

 

Reports and Other Data Deliverables.

    $[*]     $[*]   

$[*]

 

SOW Reference

2.4.1, 2.4.2, 2.5.2, 2.6.3, 2.6.5

0003

   14 November 2015 through 27 March 2017.   

[*]

Reports and Other Data Deliverables.

  $[*]   $[*]   

$[*]

 

SOW Reference

3.3.3, 3.4.1, 3.5.2, 3.6.3, 3.6.5

0005

   9 November 2017 through 23 May 2018.   

[*]

 

Reports and Other Data Deliverables.

  $[*]   $[*]   

$[*]

 

SOW Reference

5.5.2;

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 

4

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

Cost  
Share  
CLIN       Estimated
Period of
Performance    Supplies/Services  

  Total Estimated  

Cost of CLIN
0004

 

  Total Estimated  

Cost CEMPRA
share

   Total Estimated
Cost  Government
Share

0004  

   28 March 2015   through 23 May 2018.   

[*]

 

Reports and Other Data Deliverables.

  $[*]     $[*]     

$[*]

 

SOW Reference

 

4.4.2,

 

CLIN 0004 is a cost share CLIN and is subject to FAR Clause 52.216-12

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 cost of the following items or activities shall be unallowable as
direct costs:

 

  1) Acquisition, by purchase or lease, of any interest in real property;

 

  2) Special rearrangement or alteration of facilities;

 

  3) Accountable Government Property (see the Contractor’s Guide for Control for
Government Property incorporated by ARTICLE G.10. of this contract);

Note: this includes the lease or purchase of any item of general purpose office
furniture or office equipment regardless of dollar value.

 

  4) Purchase or lease scientific instruments or equipment over $1,500

 

  5) Travel to attend general scientific meetings/conferences;

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 

5

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

  6) Printing Costs (as defined in the Government Printing and Binding
Regulations);

 

  7) Overtime (premium) compensation

 

  8) Entering into certain types subcontract of arrangements (See Article B.5(c)
for specific obligations). Note that most consulting agreements require a
Contracting Officers Authorization (COA).

 

  9) Foreign Travel;

 

  10) Patient care costs (see Attachment 6);

 

b. Travel Costs

 

  1. Total expenditures for travel (transportation, lodging, subsistence, and
incidental expenses) incurred in direct performance of this contract during the
base segment (CLIN001) or any option segment(s) shall not exceed $[*] without
the prior written approval of the Contracting Officer.

If, pursuant to FAR Clause 52.217-9 (Option to Extend the Term of the Contract),
the Government exercises an option, travel costs for each CLIN shall not exceed
the following schedule:

Option 1 (CLIN 0002) -  $[*]

Option 2 (CLIN 0003) -  $[*]

Option 3 (CLIN 0004) -  $[*] (BARDA share which excludes Cempra’s portion of
travel costs for this Cost Share CLIN)

Option 4 (CLIN 0005) -  $[*]

 

  2. Subject to the annual dollar limitation specified under B.4.b.1. above, the
Contactor shall invoice and be reimbursed for all travel costs in accordance
with Federal Acquisition Regulation (FAR) 31. .2 – Contracts with Commercial
Organizations, Subsection 31.205-46, Travel Costs.

 

  3. If foreign travel is necessary, a COA will be required. Expenditures for
foreign travel (transportation, lodging, subsistence, and incidental expenses)
incurred in direct performance of this contract shall not exceed the amount
specified in each approved COA, without the prior written approval of the
Contracting Officer.

Requests for foreign travel must be submitted at least four weeks in advance and
shall contain the following:

(a) meeting(s) and place(s) to be visited, with breakout of costs and dates;

(b) name(s) and title(s) of Contractor personnel to travel and their functions
in the contract project;

(c) contract purposes 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
ASPR contract funds;

(e) how such advantages justify the costs for travel and absence from the
project of more than one person if such are suggested; and

(f) what additional functions may be performed by the travelers to accomplish
other purposes of the contract and thus further benefit the project.

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 

6

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ARTICLE B.5. ADVANCE UNDERSTANDINGS

 

  a. FDA Guidance

At the time of contract award, dated May 20, 2013, specific guidance from the
FDA associated with optional CLIN 0004 ([*]) in a pediatric population is not
available. The Contractor will conduct a meeting with the FDA during the base
period of performance (CLIN 0001) of the contract to determine an appropriate
strategy for obtaining approval of Solithromycin (CEM-101) for the treatment of
Community Acquired Bacterial Pneumonia in pediatric populations. The GO/NO GO
Contract Milestone #1 under Article F of this contract outlines the specific end
products that the Contractor must meet before the Government will consider
exercising the follow-on option segment [CLIN0004]. Article F of this contract
describes the Go Criteria for Milestone #1 as [*].

In the event that the FDA provides guidance that extrapolation of efficacy data
from adult populations is sufficient to support a label indication for a
pediatric population without performing a pediatric efficacy study, activities
described in the statement of work under attachment J, item 1 may be modified.

The contracting officer may request a modified statement of work for CLIN 0004
to align with the FDA guidance to ensure the Contractor can obtain relevant data
to support submission of a NDA for their pediatric indication.

Any contract modification to the statement of work under CLIN 0004 will not
impact the percentage of cost sharing under CLIN 0004 as agreed to by the
Government and the Contractor prior to contract award. The Contractor to
Government cost sharing distribution of [*]%:[*]% may not be renegotiated.

The GO/NO GO Contract Milestones and Decision Gates will constitute the basis
for the Government’s decision, at its sole discretion, to exercise CLIN 0004.

 

  b. Man-in-Plant

With seven (7) days advance notice to the Contractor in writing from the
Contracting Officer, the Government may place a man-in-plant in the Contractor’s
facility, who shall be subject to the Contractor’s policies and procedures
regarding security and facility access at all times while in the Contractor’s
facility. As determined by federal law, no Government representative shall
publish, divulge, disclose, or make known in any manner, or to any extent not
authorized by law, any information coming to him in the course of employment or
official duties, while stationed in a contractor plant.

 

  c. Security Plan

No Security Plan is required at this point for this effort. It is anticipated a
security waiver will be approved. In the event a security waiver cannot
successfully be attained, a security plan must be delivered to the Government
subsequently.

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 

7

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  d. Subcontracts and Consultants

Prior written consent from the Contracting Officer in the form of Contracting
Officer Authorization (COA) is required for any subcontract that is a
cost-reimbursement type or fixed price and exceeds $[*].

Contracting Officer shall request appropriate supporting documentation in order
to review and determine authorization, pursuant with FAR Clause 52.244-2,
Subcontracts. After receiving written consent of the subcontract by the
Contracting Officer, a copy of the signed, executed subcontract and consulting
agreement shall be provided to the Contracting Officer.

Note: Consulting services are treated as subcontracts and subject to the
‘consent to subcontract’ provisions set forth in this Article.

 

  d. Site Visits and Inspections

At the discretion of the USG and independent of activities conducted by the
Contractor, with 48 hours notice to the contractor, the USG reserves the right
to conduct site visits and inspections on an as needed basis, including
collection of product samples 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. All costs reasonably incurred by the
Contractor and subcontractor for such visit and/or inspection shall be allowed
costs. The Contractor shall coordinate these visits and shall have the
opportunity to accompany the USG on any such visits. Under time-sensitive or
critical situations, the USG reserves the right to suspend the 48 hour notice to
the Contractor. The areas included under the site visit could include, but are
not limited to: security, regulatory and quality systems, and cGMP/GLP/GCP
compliance.

If BARDA, the Contractor, or other parties identifies any issues during an
audit, the Contractor shall capture the issues, identify potential solutions,
and provide a report to BARDA for review and acceptance.

 

  —  

If issues are identified during the audit, Contractor shall submit a report to
BARDA detailing the finding and corrective action(s) within 10 business days of
the audit.

  —  

COR and CO will review the report and provide a response to the Contractor
within 10 business days.

  —  

Once corrective action is completed, the Contractor will provide a final report
to BARDA.

QA AUDIT:

BARDA reserves the right to participate in QA audits. Upon completion of the
audit/site visit the Contractor shall provide a report capturing the findings,
results and next steps in proceeding with the subcontractor. If action is
requested of the subcontractor, detailed concerns for addressing areas of
non-conformance to FDA regulations for GLP, GMP, or GCP guidelines, as
identified in the audit report, must be provided to BARDA for review and
acceptance. The Contractor shall provide responses from the subcontractors to
address these concerns and plans for corrective action execution.

 

  —  

Contractor shall notify CO and COR of upcoming, ongoing, or recent audits/site
visits of subcontractors as part of weekly communications

  —  

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

 

  e. Invoices - Cost and Personnel Reporting and Variances from the Negotiated
Budget

See Attachment #2 for detailed requirements for Invoicing.

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 

8

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The Contractor agrees to provide a detailed breakdown on invoices of the
following cost categories:

 

  a. Direct Labor - List individuals by name, title/position, hourly/annual
rate, level of effort (actual hours or % of effort), breakdown by task performed
by personnel, and amount claimed.

  b. Fringe Benefits - Cite rate and amount

  c. Overhead - Cite rate and amount

  d. Materials & Supplies - Include detailed breakdown when total amount is
greater than $1,500.

  e. 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.

  f. Consultant Fees - Identify individuals and amounts. Cite appropriate COA.

  g. Subcontracts - Attach Subcontractor invoice(s). Cite appropriate COA.

  h. Equipment - Cite authorization and amount. Cite appropriate COA.

  i. Other Direct Costs - Include detailed breakdown when total amount is
greater than $1,500.

  j. G&A - Cite rate and amount.

  k. Total Cost

  l. Fixed Fee

  m. Total CPFF

Monthly invoices must include the cumulative total expenses to date, adjusted
(as applicable) to show any amounts suspended by the Government. In order to
verify allowability, further breakdown of costs may be requested at the
Government’s discretion.

See Attachment #2 for detailed requirements for Invoicing

 

  f. Confidential Treatment of Sensitive Information

The Contractor shall guarantee strict confidentiality of any information/data of
a sensitive nature that is provided to the Contractor 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 information/data that is sensitive in nature, in whole or in part,
by the Contractor can only be made after the Contractor receives prior written
approval from the Contracting Officer. Whenever the Contractor is uncertain with
regard to the proper handling of information/data under the contract, the
Contractor shall obtain a written determination from the Contracting Officer.
(See also HHSAR clause 352.224-70).

Notwithstanding the foregoing, such information/data shall not be deemed of a
sensitive nature with respect to the Contractor for purposes of this contract if
such information/data: (a) was already known to the Contractor; (b) was
generally available or known, or was otherwise part of the public domain, at the
time of its disclosure to the Contractor; (c) became generally available or
known, or otherwise became part of the public domain, after its disclosure to,
or, with respect to the information/data by, the Contractor through no fault of
the Contractor; (d) was disclosed to the Contractor, other than under an
obligation of confidentiality or non-use, by a third party who had no obligation
to the Government that controls such information/data not to disclose such
information/data to others; or (e) was independently discovered or developed by
the Contractor, as evidenced by its written records, without the use of
information/data belonging to the Government.

 

9

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Contractor may disclose information/data of a sensitive nature provided by the
Government to the extent that such disclosure is: (a) made in response to a
valid order of a court of competent jurisdiction or other supra-national,
federal, national, regional, state, provincial or local governmental or
regulatory body of competent jurisdiction; provided, however, that the
Contractor shall first have given notice to the Government and give the
Government a reasonable opportunity to quash such order and to obtain a
protective order requiring that the information/data of a sensitive nature that
is the subject of such order be held in confidence by such court or agency or,
if disclosed, be used only for the purposes for which the order was issued; and
provided further that if a disclosure order is not quashed or a protective order
is not obtained, the information/data disclosed in response to such court or
governmental order shall be limited to that information which is legally
required to be disclosed in response to such court or governmental order;
(b) otherwise required by law, in the opinion of legal counsel to the Contractor
as expressed in an opinion letter in form and substance reasonably satisfactory
to the Government, which shall be provided to the Government at least two
(2) business days prior to the Contractor’s disclosure of the information/data;
or (c) made by the Contractor to the Regulatory Authorities as required in
connection with any filing, application or request for Regulatory Approval;
provided, however, that reasonable measures shall be taken to assure
confidential treatment of such information/data.

 

  g. 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.

 

  h. Overtime Compensation

No overtime (premium) compensation is authorized under the subject contract.
Billing of actual hours is limited to total productive hours in a month.

 

10

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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 set forth in SECTION J-List of Attachments, attached hereto
and made a part of the contract.

ARTICLE C.2. REPORTING REQUIREMENTS

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

ARTICLE C.3. EARNED VALUE MANAGEMENT SYSTEM (EVMS) IMPLEMENTATION REQUIREMENTS

The Contractor and BARDA agree that the EVMS implementation requirements that
are contained in this contract are limited to the implementation requirements
outlined by the 7 Principles of Earned Value Management Tier 2 System
Implementation Intent Guide contained in the Attachments (Section J) of the
contract. The total amount of this contract reflects the use of the 7 Principles
of EVMS Implementation. Any EVMS implementation requirements that are beyond the
intent of the 7 Principles of EVMS Implementation shall not proceed until the
Contracting Officer sends a written request for a proposal to the Contractor and
a bilateral modification is issued to the contract for the purposes of
incorporating the additional costs for the performance of these requirements
into the contract.

Refer to ARTICLE F.2. for specifics on EVMS deliverables.

ARTICLE C.4. PROJECT MEETING CONFERENCE CALLS ONCE EVERY TWO WEEKS

A teleconference call between the Contracting Officer’s Representative and the
Contractor’s Program Manager shall occur bi-weekly (every two weeks), or at the
discretion of the U.S. Government. During this call, the Program Manager will
discuss the activities during the reporting period, any problems that have
arisen, and the activities planned for the ensuing reporting period. The
Contractor’s Program Manager 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 Representative.

Contractor will be responsible for preparing an agenda for the conference call
and providing to BARDA no later than 2 business days prior to the scheduled
conference call.

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 BARDA/AMCG
in Washington, D.C. and at work sites of the Contractor and its
subcontractors. Such meetings may include, but are not limited to, meetings of
the Contractor (and subcontractors invited by the Contractor) to discuss study
designs, site visits to the Contractor’s and subcontractor’s facilities, and
meetings with the Contractor and HHS officials to discuss the technical,
regulatory, and ethical aspects of the program. The Contractor must provide
data, reports, and presentations to groups of outside experts (subject to
appropriate protections for Contractor confidential or proprietary data) and USG
personnel as required by the Contracting Officer’s Technical Representative in
order to facilitate review of contract activities.

 

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  a. Kickoff Meeting

The Contractor shall complete a Kickoff meeting within [*] days after contract
award. Contractor shall provide an itinerary/agenda no later than 5 business
days before meeting.

 

  b. Quarterly and Ad-Hoc Meetings

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

Contractor shall provide itinerary/agenda at least 5 business days in advance of
face-to-face meeting.

ARTICLE C.6 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 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).

Reports and documentation submitted to the Contracting Officer shall be sent to
the Contracting Officer to the address set forth in SECTION G – CONTRACT
ADMINISTRATION DATA.

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

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 

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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.

Report Deliverables

Unless otherwise specified by the Contracting Officer, delivery of reports to be
furnished to the Government under this contract (including invoices), shall be
delivered to BARDA electronically along with a concurrent email notification to
the Contracting Officer, Contract Specialist, and COR summarizing the electronic
delivery.

Delivery of physical reports to be furnished shall be addressed to the COR, CO,
and CS (as defined in SECTION G – CONTRACT ADMINISTRATION DATA).

 

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SECTION E – INSPECTION AND ACCEPTANCE

 

  1. The Contracting Officer (CO) or the duly authorized representative will
perform inspection and acceptance of materials and services to be provided under
this contract.

 

  2. For the purpose of this SECTON, the designated Contracting Officer’s
Representative (COR) is the authorized representative of the Contracting
Officer. The COR will assist in resolving technical issues that arise during
performance. The COR however is not authorized to change any contract terms or
authorize any changes in the Statement of Work or modify or extend the period of
performance, or authorize reimbursement of any costs incurred during
performance.

 

  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 G644

Washington, D.C. 20201

 

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SECTION F – DELIVERIES OR PERFORMANCE

ARTICLE F.1. ESTIMATED PERIOD OF PERFORMANCE

Under CLIN 0001, the estimated period of performance for the base performance
segment of this contract shall be consistent with the dates set forth in ARTICLE
B.2. If the Government exercises its option(s) pursuant to the Option Clauses in
Article G.11 and Article I.2 of the contract, the period of performance (PoP)
will be increased as shown in the table in Article B.3.

ARTICLE F.2. DELIVERABLES

Successful performance of the final contract shall be deemed to occur upon
performance of the work set forth in the Statement of Work, dated April 17, 2013
set forth in SECTION J-List of Attachments of this contract and upon delivery
and acceptance, as required by the Statement of Work, by the Contracting
Officer, or the duly authorized representative, of the following items in
accordance with the stated delivery schedule:

The items specified below as described in the REPORTING REQUIREMENTS Article in
SECTION C of this contract and the Statement of Work set forth in SECTION J-List
of Attachments will be required to be delivered in accordance with and by the
date(s) specified below and any specifications stated in SECTION D, PACKAGING,
MARKING AND SHIPPING, of this contract. All reports identified below relate
solely to the development activity funded under this contract:

 

1. Summary of Contract Deliverables

Unless otherwise stated, each deliverable in the table below shall be provided
as one (1) electronic copy to the COR and CO.

CDRL#   Deliverable   Deliverable Description   Reporting Procedures and Due
Dates 01   Kickoff Meeting   The Contractor shall complete a Kickoff meeting
after contract award  

 

—             Within [*] days of contract award.

—            Contractor shall provide itinerary and agenda at least 5 business
days in advance of site visit.

—            COR approves and distributes itinerary and agenda within 3 business
days.

—            Contractor provides meeting minutes to COR within 3 business days
after the meeting.

—            COR reviews, comments, and approves minutes within 10 business
days.

 

02  

Quarterly

Meetings

  The Contractor shall hold recurring Program Review Meetings approximately
every third month. The meetings will be used to discuss contract progress in
relation to the Program Management deliverables described below as well as study
designs, technical, regulatory, and ethical aspects of the program.  

—             Contractor provides Quarterly Status Report five business days
prior to meeting. This report is an expanded version of the Monthly Status
Report.

—            Contractor shall provide itinerary, agenda and meeting slides at
least 5 business days in advance of the meeting.

—            COR approves and distributes itinerary and agenda within 3 business
days.

—            Contractor provides meeting minutes to COR within 3 business days
after the meeting.

—            COR reviews, comments, and approves minutes within 10 business
days.

 

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 

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CDRL#   Deliverable   Deliverable Description   Reporting Procedures and Due
Dates 03   Project Status meeting   The Contractor shall participate in
teleconferences every two weeks with BARDA to discuss the performance of the
contract.  

—            Contractor provides agenda to COR no later than 2 business days in
advance of meeting

—            COR approves (with CO concurrence) and distributes agenda prior to
meeting

—            Contractor provides meeting minutes to COR within 3 business days
of the meeting

—            COR reviews, comments, and approves minutes within 10 business
days.

 

04  

Monthly,

Quarterly & Annual Project Status Report/Annual Meeting

 

The Monthly and Annual Technical Progress report shall address each of the below
items and be cross-referenced to the Work Breakdown Structure (WBS), Statement
of Work (SOW), Integrated Master Schedule (IMS), Performance Measurement
Baseline Review report (PMBR), Earned Value Management (EVM), and Contract
Performance Report (CPR).

 1.  An Executive Summary highlighting the progress, issues and relevant
manufacturing, non-clinical, clinical and regulatory activities. The Executive
Summary should highlight only critical issues for that reporting period and
resolution approach; limited to 2-3 pages.

 2.  Progress in meeting contract milestones – broken out by subtasks within
each milestone, overall project assessment, problems encountered and recommended
solutions. The reports shall detail the planned and actual progress during the
period covered, explaining occurrences of any differences between the two and
the corrective steps.

 3.  The reports shall also include a three-month rolling forecast of the key
planned activities, referencing the WBS/IMS.

 4.  A tracking log of progress on regulatory submissions with the FDA number,
description of submission, date of submission, status of submission and next
steps.

 5.  IMS updates

 6.  Provide updated EVM CPR

 7.  Estimated and Actual Expenses.

      a. This report shall also contain a narrative or table detailing whether
there is a significant discrepancy (>10%) at this time between the % of work
completed and the cumulative costs incurred to date. Monthly and actual expenses
should be broken down to the appropriate WBS level. This section of the report
should also contain estimates for the Subcontractors’ expenses from the previous
month if the Subcontractor did not submit a bill in the previous month. If the
subcontractor(s) was not working or did not incur any costs in the previous
month, then a statement to this effect should be included in this report for
those respective subcontractors.

 

 

—            Monthly Reports shall be submitted on the 20th calendar day of each
month or the next business day, with an Annual Report submitted on the 20th
calendar day of the final month of each contract year for the previous twelve
calendar months. Monthly progress reports are not required for the periods when
the Annual Report(s) and Final Report are due. The COR and CO will review the
monthly reports with the Contractor and provide feedback.

 

—            Contractor provides Annual Project Status Report deliverables 5
business days prior to meeting. A draft report including .ppt slides should be
provided 5 business days prior to the meeting. The annual report should also
include information from the annual meeting due 15 business days after the
meeting.

—            COR approves (with CO concurrence) and distributes agenda no later
than 2 business days in advance of meeting

—            COR approves (with CO concurrence) all meeting material no later
than 2 business days in advance of meeting

—            Contractor provides meeting minutes within 5 business days of
meeting

—            COR reviews, comments, and approves minutes within 10 business days
of receipt

—            Contractor provides FINAL annual report within 15 business days
after the conclusion of the annual meeting.

—            COR reviews, comments, and approves (with CO concurrence) FINAL
Annual Report

—            BARDA and Contractor shall participate in an in-process review.

 

 

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CDRL#   Deliverable   Deliverable Description   Reporting Procedures and Due
Dates 05   Earned Value Management (EVM) / Contract Performance Report (CPR)  

Contractor will provide a monthly Contract Performance Report (CPR) Format 1 at
an agreed upon reporting level using the BARDA provided WBS and a Variance
Analysis Report (Format 5).

 

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

 

—            Contractor shall provide EVM/CPR as part of the Monthly Progress
Report on the 20th day of the month after the end of each month

—            Contractor shall provide top level or key changes in baseline cost
as a result of anticipated cost savings or risks

—            BARDA may request, on a monthly or ad hoc basis that the Contractor
provide raw data at a reporting level or lower level as BARDA deems necessary.

—            Contractor must address, in writing, all concerns raised by BARDA.

 

06   Performance Measurement Baseline Review (PMBR)  

PMBR Report shall address each of the items listed below and be cross-referenced
to the IMP, WBS, SOW, and Risk Management Plan.

1. Contractor provides baseline proposal

2. Responsibility Assignment Matrix

3. A description of the work scope through control account Work Authorization
Documents and/or WBS Dictionary down to the control account level

4. Template for work packages

5. IMS with the inclusion of agreed major milestones and control account plans
for all control accounts

6. Baseline revision documentation and program log(s) risk management plan

 

—            Due within 90 days of contract award

—            Contractor shall provide baseline proposal .ppt briefing 10
business days prior to meeting

—            Contractor provides agenda to COR 2 business days in advance of
meeting

—            COR approves (with CO concurrence) and distributes agenda no later
than 2 business days in advance of meeting

—            COR approves (with CO concurrence) all meeting material no later
than 2 business days in advance of meeting

—            Contactor provides minutes within 3 business days of the meeting

—            COR reviews and approves (with CO concurrence) minutes

—            BARDA will review documentation and provide written comments and
questions to Contractor

  Contractor shall address BARDA’s comments and resubmit PMBR report for BARDA
approval within 10 business days.

 

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

—            Due within 90 days of contract award

—            Contractor provides updated Risk Management Plan in Monthly
Progress Report

—            BARDA shall provide Contractor with a written list of concerns in
response plan submitted

—            Contractor must address, in writing, all concerns raised by BARDA
within 20 business days of Contractor’s receipt of BARDA’s concerns.

 

08   Deviation Notification and Mitigation Strategy   Process for changing IMS
activities associated with cost and schedule as baselined at the PMBR.
Contractor shall notify BARDA of significant changes the IMS defined as
increases in cost above [*]% for Go/No Go milestones or schedule slippage of
more than [*] days, which would require a PoP extension. Contractor shall
provide a high level management strategy for risk mitigation.  

—            Due as needed

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 

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CDRL#   Deliverable   Deliverable Description   Reporting Procedures and Due
Dates 09   Go/No-Go Decision Gate Presentation   Contractor shall provide a
presentation detailing technical progress made towards completion of Go/No-Go
decision gate milestones following a prescribed template provided by BARDA prior
to the IPR  

—            Contractor shall provide presentation in .ppt format 10 business
days prior to the In-Process Review (IPR)

—            Contractor shall submit written justification of progress towards
satisfying Go/No-Go criteria

—            After reviewing, BARDA COR and CO will provide a written response.

 

10   Incident Report   Contractor shall communicate and document all critical
programmatic concerns, risks, or potential risks with BARDA.  

—            Due within 48 hours of activity or incident or within 24 hours for
a security activity or incident

—            Email or telephone with written follow-up to COR and CO

—            Additional updates due to COR and CO within 48 hours of additional
developments

—            Contractor shall submit within 5 business days a Corrective Action
Plan (if deemed necessary by either party) to address any potential issues.

—            If corrective action is deemed necessary, Contractor must address
in writing, its consideration of concerns raised by BARDA within 5 business
days.

 

11   Draft and Final Technical Progress Report  

A draft Final Technical Progress Report containing a summation of the work
performed and the results obtained for the entire contract PoP. The draft report
shall be duly marked as ‘Draft’.

 

The Final Technical Progress Report incorporating feedback received from BARDA
and containing a summation of the work performed and the results obtained for
the entire contract PoP. The final report shall document the results of the
entire contract. This report shall be in sufficient detail to fully describe the
progress achieved under all milestones. The final report shall be duly marked as
‘Final’.

 

—            Contractor shall provide a draft Technical Progress Report 75
calendar days before the end of the PoP and the Final Technical Progress Report
on or before the completion date of the PoP.

—            Subcontractor prepared reports received by the Prime Contractor
shall be submitted to the COR and CO for review and comment no later than 5
business days after receipt by the prime contractor

—            COR shall provide feedback on draft report within 10 business days
of receipt, which the Contractor shall consider incorporating into the Final
Report

—            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.

 

12   Draft and Final Reports for Clinical and Non-Clinical Studies  

 

Contractor shall provide Draft and Final Clinical/Non-Clinical Study Reports to
BARDA for review and comment.

 

—            Draft report due within 45 calendar days after completion of
analysis and at least 15 business days prior to submission to FDA.

—            Subcontractor prepared reports received by the Prime Contractor
shall be submitted to the Contracting Officer’s Representative (COR) and
Contracting Officer (CO) for review and comment no later than 5 business days
after receipt by Prime Contractor.

 

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CDRL#   Deliverable   Deliverable Description   Reporting Procedures and Due
Dates            

—            The Government shall provide written comments to the Draft Final
Report for Clinical and Non-Clinical Studies within 10 business days after the
submission.

—             Final report due 30 calendar days after receiving comments on the
Draft Final Report for Clinical and Non-Clinical Studies. If corrective action
is recommended, Contractor must address, in writing, all concerns raised by
BARDA.

—            Contractor shall consider revising reports to address BARDA’s
recommendations prior to FDA submission.

—            Final FDA submissions shall be provided to BARDA concurrently or no
later than 1 business day after submission to the FDA.

 

13   Standard Operating   Procedures     The Contractor shall make internal and
subcontractor Standard Operating Procedures (SOPs) available for review
electronically.   Upon request from the Contracting Officer
Representative/Contracting Officer 14   Manufacturing   Campaign Reports    

Contractor shall provide Manufacturing Campaign Reports to BARDA for review and
comment prior to submission to FDA.

 

The COR and CO reserve the right to request within the PoP a non-proprietary
Manufacturing Campaign Report for distribution within the USG.

 

—            Contractor will submit Manufacturing Campaign Reports at least 15
business days prior to FDA submission.

—            If corrective action is recommended, Contractor must address, in
writing, all concerns raised by BARDA.

—            Contractor shall consider revising reports to address BARDA’s
concerns and/or recommendations prior to FDA submission.

—            Final FDA submission shall be submitted to BARDA concurrently or no
later than 1 business day after submission to the FDA.

 

15   FDA Correspondence     The Contractor shall memorialize any correspondence
related to this contract between Contractor and FDA and submit to BARDA. All
documents shall be duly marked as either “Draft” or “Final”.  

—            Contractor shall provide written summary of any FDA correspondence
within 5 business days of correspondence.

 

16   FDA Meetings     The Contractor shall forward the dates and times of any
meeting related to this contract with the FDA to BARDA and make arrangements for
appropriate BARDA staff to attend the FDA meetings. BARDA staff shall include up
to a maximum of four people (COR, CO and up to 2 subject matter experts).  

—            Contractor shall notify BARDA of upcoming FDA meeting within 24
hours of scheduling Type A, B or C meetings OR within 24 hours of meeting
occurrence for ad hoc meetings.

—             The Contractor shall forward initial Contractor and FDA-issued
draft minutes and final minutes of any meeting with the FDA to BARDA within 5
business days of receipt. All documents shall be duly marked as either “Draft”
or “Final”.

 

 

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CDRL#   Deliverable   Deliverable Description   Reporting Procedures and Due
Dates 17   FDA Submissions   The Contractor shall provide BARDA the opportunity
to review and comment upon all draft documents before submission to the FDA.
Contractor shall provide BARDA with an electronic copy of the final FDA
submission. All documents shall be duly marked as either “Draft” or “Final”.  

—            Contractor shall submit draft FDA submissions to BARDA at least 15
business days prior to FDA submission

—            BARDA will provide feedback to Contractor within 10 business days
of receipt

—            If corrective action is recommended, the Contractor must address,
in writing, its consideration of all concerns raised by BARDA

—            The Contractor shall consider revising their documents to address
BARDA’s concerns and/or recommendations prior to FDA submission

—            Final FDA submissions shall be submitted to BARDA concurrently or
no later than 1 calendar day of it submission to CDER.

 

18   FDA Audits  

In the event of an FDA inspection which occurs as a result of this contract and
for the product, or for any other FDA inspection that has the reasonable
potential to impact the performance of this contract, the Contractor shall
provide the USG with an exact copy (non-redacted) of the FDA Form 483 and the
Establishment Inspection Report (EIR). The Contractor shall provide the COR and
CO with copies of the plan for addressing areas of non-conformance to FDA
regulations for GLP, GMP, or GCP guidelines as identified in the audit report,
status updates during the plans execution and a copy of all final responses to
the FDA. The Contractor shall also provide redacted copies of any FDA audits
received from subcontractors that occur as a result of this contract or for this
product. The Contractor shall make arrangements for BARDA representative(s) to
be present during the final debrief by the regulatory inspector.

 

 

 

—            Contractor shall notify CO and COR within 10 business days of a
scheduled FDA audit or within 24 hours of an ad hoc site visit/audit if the FDA
does not provide advanced notice.

—            Contractor shall provide copies of any FDA audit report received
from subcontractors that occur as a result of this contract or for this product
within 5 business days of receiving correspondence from the FDA or third party.

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

 

19   QA Audit Reports   BARDA reserves the right to participate in QA audits.
Upon completion of the audit/site visit the Contractor shall provide a report
capturing the findings, results and next steps in proceeding with the
subcontractor. If action is requested of the subcontractor, detailed concerns
for addressing areas of non-conformance to FDA regulations for GLP, GMP, or GCP
guidelines, as identified in the audit report, must be provided to BARDA. The
Contractor shall provide responses from the subcontractors to address these
concerns and plans for corrective action execution.  

—            Contractor shall notify CO and COR 10 days in advance of upcoming,
ongoing, or recent audits/site visits of subcontractors as part of weekly
communications

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

20   BARDA Audit   Contractor shall accommodate periodic or ad hoc site visits
by BARDA. If BARDA, the Contractor, or other parties identifies any issues
during an audit, the Contractor shall capture the issues, identify potential
solutions, and provide a report to BARDA.  

—            If issues are identified during the audit, Contractor shall submit
a report to BARDA detailing the finding and corrective action(s) within 10
business days of the audit.

—             CO and COR will review the report and provide a response to the
Contractor with 10 business days.

—            Once corrective action is completed, the Contractor will provide a
final report to BARDA.

 

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CDRL#   Deliverable   Deliverable Description   Reporting Procedures and Due
Dates 21   Technical Documents   Upon request, Contractor shall provide CO and
COR with deliverables from the following contract funded activities: process
Development Reports, Assay Qualification Plan/Report, Assay Validation
Plan/Report, Assay Technology Transfer Report, Batch Records, SOPs, Master
Production Records, Certificate of Analysis, Clinical Studies Data or Reports.
The CO and COR reserve the right to request within the PoP a non-proprietary
technical document for distribution within the USG.  

 

—            Contractor shall provide technical document within 10 business days
of CO or COR request. Contractor can request additional time on an as needed
basis.

—            If corrective action is recommended, the Contractor must address,
in writing, concerns raised by BARDA

 

22  

Animal Model or Other

Technology Transfer

Package

  Contractor shall provide Animal Model or Other Technology Transfer Package
relevant data  

 

—            Contractor shall provide package within 10 business days of CO or
COR request.

 

23  

Raw Data or

Data Analysis

  Contractor shall provide raw data or data analysis to BARDA upon request  

—            Contractor shall provide data or data analysis to CO and COR within
20 business days of request.

 

24  

Product

Transition

Strategy

 

Contractor shall provide a 2-4 page summary document containing a Product
Transition Strategy to support transition of the product(s) prior to end of the
base and/or option(s) POP. The Product Transition Strategy should provide a
strategic plan for further development and/or stockpiling of the product

The transition strategy shall provide options and/or a specific approach for the
transition of MCM product for further development, procurement, approval and/or
stockpile

 

 

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

 

25   Publications   Any manuscript or scientific meeting abstract containing
data generated under this contract must be submitted to BARDA for review prior
to submission  

—Contractor must submit all manuscript or scientific meeting abstract to CO and
COR within 20 business days for manuscripts and 10 business days for abstracts

—Contractor must address in writing all concerns raised by BARDA

—            Final submissions shall be submitted to BARDA concurrently or no
later than one (1) calendar day of its submission

 

26   Press Releases   Contractor agrees to accurately and factually represent
the work conducted under this contract in all press releases  

—Contractor shall ensure that the CO has received and approved an advanced copy
of any press release to this contract not less than 5 business days prior to the
issuance of the press release

—If corrective action is required, the Contractor agrees to accurately and
factually represent the work conducted under this contract in all press releases

—Any final submissions shall be submitted to BARDA concurrently or no later than
one (1) calendar day of its submission.

NOTE: Pursuant to federal law, no Government personnel shall publish, divulge,
disclose, or otherwise make known to any non-government entity any Contractor
data marked according to FAR regulation, unless permitted to do so by law or
regulation.

 

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2. Detailed Description of Select Contract Deliverables

 

  A. Monthly and Annual Progress Reports

In addition to those reports required by the other terms of this contract, the
Contractor shall prepare and submit the following reports in the manner stated
below and in accordance with this Article F of this contract, and in SECTION
J-List of Attachments, attached hereto and made a part of the contract.

 

  i. Monthly Progress Report

This report shall include a description of the activities during the reporting
period, and the activities planned for the ensuing reporting period. The first
reporting period consists of the first full month of performance plus any
fractional part of the initial month. Thereafter, the reporting period shall
consist of each calendar month.

The Contractor shall submit a Monthly Progress Report according to the dates set
forth in the summary table under this article. The format should include:

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; The progress report
shall conform to the requirements set forth in the DELIVERIES Article in SECTION
F of this contract.

  —  

SECTION I – EXECUTIVE SUMMARY

  —  

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, 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 related to Gantt
chart for the next reporting period and preprints/reprints of papers and
abstracts.

  —  

SECTION III: Estimated and Actual Expenses.

 

22

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a. This report shall also contain a narrative or table detailing whether there
is a significant discrepancy (>[*]%) at this time between the % of work
completed and the cumulative costs incurred to date. Monthly and actual expenses
should be broken down to the appropriate WBS level. This section of the report
should also contain estimates for the Subcontractors’ expenses from the previous
month if the Subcontractor did not submit a bill in the previous month. If the
subcontractor(s) was not working or did not incur any costs in the previous
month, then a statement to this effect should be included in this report for
those respective subcontractors.

  —  

SECTION III: Earned Value Management Reporting: Contractor will provide a
monthly Contract Performance Report (CPR) at an agreed upon reporting level (WBS
level 3) 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. In
accordance with FAR 52.215-2, Audit and Records-Negotiation, 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.

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

 

  ii. Annual Progress Report

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

The first Annual Progress Report shall be submitted in accordance with the date
set forth in the table under ARTICLE F.2. of this contract.

Each Annual Progress Report shall include:

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 email address; and the date of submission; The progress report shall
conform to the requirements set forth in the DELIVERIES Article in SECTION F of
this contract.

 

  —  

SECTION I: EXECUTIVE SUMMARY - A brief overview of the work completed, and the
major accomplishments achieved during the reporting period.

  —  

SECTION II: PROGRESS

  —  

SECTION II Part A: OVERALL PROGRESS - A description of overall progress.

  —  

SECTION II Part B: MANAGEMENT AND ADMINISTRATIVE UPDATE - A high level summary
of critical meetings, etc. that have taken place during the reporting period.
Include progress on administration and management to critical factors of the
project (e.g. regulatory compliance audits and key personnel changes).

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 

23

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  —  

SECTION II Part C: TECHNICAL PROGRESS - A detailed description of the work
performed structured to follow the activities and decision gates outlined at the
Integrated Baseline Review and as described in the Integrated Master Plan. The
Report should include a description of any problems (technical or financial)
that occurred or were identified during the reporting period, and how these
problems were resolved.

  —  

SECTION II Part D: PROPOSED WORK - A summary of work proposed for the next year
period to include an updated Gantt Chart.

  —  

SECTION III: Estimated and Actual Expenses.

a. This report shall also contain a narrative or table detailing whether there
were discrepancies between estimated and actual expenses over the past year.
Actual expenses should be broken down to the appropriate WBS level. This section
of the report should also contain estimates for outstanding costs for the
previous year which may have been incurred, but not yet billed.

  —  

SECTION IV: EARNED VALUE MANAGEMENT REPORTING - Contractor will provide a
quarterly Contract Performance Report (CPR) at an agreed upon (WBS level 3)
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.
In accordance with FAR 52.215-2, Audit and Records-Negotiation, 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.

Contractor also should include the following in the Annual Progress Report:

 

  1. Copies of manuscripts (published and unpublished), abstracts, and any
protocols or methods developed specifically under the contract during the
reporting period; and

 

  2. A summary of any Subject Inventions per the requirements under FAR Clause
52.227-11.

 

  iii. Draft Final Report and Final Report

These reports are to include a summation of the work performed 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. An Annual Progress Report will
not be required for the period when the Final Report is due. The Draft Final
Report and the Final Report shall be submitted in accordance with the dates set
forth in ARTICLE F.2. of this 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,
email address and submission date.

 

  3. 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.

 

  4. SECTION II: RESULTS - A detailed description of the work performed related
to WBS and Gantt chart, the results obtained, and the impact of the results on
the scientific and/or public health community including a listing of all
manuscripts (published and in preparation) and abstracts presented during the
entire period of performance and a summary of all inventions.

 

24

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Draft Final Report: The Contractor is required to submit the Draft Final Report
to the Contracting Officer’s Representative and Contracting Officer. The
Contracting Officer’s Representative and Contracting Officer will review the
Draft Final Report and provide the Contractor with comments in accordance with
the dates set forth in ARTICLE F.2. of this contract.

Final Report: The Contractor will deliver the final version of the Final Report
on or before the completion date of the contract. The final version shall
include or address the Contracting Officer’s Representative comments and
Contracting Officer comments on the draft report. Final Report shall be
submitted on or before the completion date of the contract.

 

  iv. Summary of Salient Results

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

 

  v. Audit Reports

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

 

  vi. Other Technical Reports

 

  1. Draft Report for Clinical and Non-Clinical Studies and Final Report for
Clinical and Non-Clinical Studies

 

  —  

The non-clinical and clinical trial reports shall follow the format of
International Conference on Harmonization document ICH E3 “Guidelines on
Structure and Content of Clinical Study Reports”
(http://www.pharmacontract.ch/support/su_ich_liste.htm)

  —  

Draft Final Report for Clinical and Non-Clinical Studies funded by this contract
will be submitted to the Contracting Officer’s Representative and Contracting
Officer (CO) for review and comment within the time frames set forth under this
section of this contract (ARTICLE F.2.).

  —  

Subcontractor prepared reports received by the Prime Contractor shall be
submitted to the Contracting Officer’s Representative and Contracting Officer
(CO) for review and comment as set forth by the table in this Article.

  —  

The Government shall provide written comments to the Draft Final Report for
Clinical and Non-Clinical Studies in accordance with the dates set forth by the
table in this Article.

  —  

The comprehensive Final Report for Clinical and Non-Clinical Studies will be
submitted to the Contracting Officer and the Contracting Officer’s
Representative set forth by the table in this Article. The final version shall
include or address the Contracting Officer’s Representative comments and
Contracting Officer comments on the draft report.

 

25

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  2. Supplemental Technical Documents

Upon request, Contractor shall provide CO and COR with the following contract
funded documents as specified below but not limited to: Process Development
Reports; Assay Qualification Plan/Report, Assay Validation Plan/Report, Assay
Technology Transfer Report, Batch Records, Contractor/Subcontractor Standard
Operating Procedures (SOP’s), Master Production Records, Certificate of
Analysis, Clinical Studies Data or Reports. The CO and COR reserve the right to
request within the Period of Performance a non-proprietary technical document
for distribution within the USG. Contractor shall provide technical document
within 10 business days of CO or COR request. Contractor can request additional
time on an as needed basis. If edits are recommended, the Contractor must
address, in writing, concerns raised by BARDA

 

  B. Deliverables Arising from FDA Correspondence

 

  i. FDA Meetings

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

 

  —  

Contractor shall notify BARDA of upcoming FDA meeting within 24 hours of
scheduling Type A, B or C meetings OR within 24 hours of meeting occurrence for
ad hoc meetings.

  —  

The Contractor shall forward initial Contractor and FDA-issued draft minutes and
final minutes of any meeting with the FDA to BARDA within 3 business days of
receipt. All documents shall be duly marked as either “Draft” or “Final”.

 

  ii. FDA Submissions

The Contractor shall provide BARDA all documents submitted to the FDA.
Contractor shall provide BARDA with an electronic copy of the final FDA
submission. All documents shall be duly marked as either “Draft” or “Final”.

 

  —  

If draft documents are submitted for BARDA review, BARDA will provide feedback
to Contractor within 10 business days of receipt.

  —  

If BARDA reviews draft documents, the Contractor shall consider revising their
documents to address BARDA’s concerns and/or recommendations prior to FDA
submission.

  —  

Final FDA submissions shall be submitted to BARDA concurrently or no later than
24 hours of their submission to FDA.

 

  iii. FDA Audits

In the event of an FDA inspection which occurs as a result of this contract and
for the product, or for any other FDA inspection that has the reasonable
potential to impact the performance of this contract, the Contractor shall
provide the USG with an exact copy (non-redacted) of the FDA Form 483 and the
Establishment Inspection Report (EIR). The

 

26

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Contractor shall provide the COR and CO with copies of the plan for addressing
areas of non-conformance to FDA regulations for GLP, GMP, or GCP guidelines as
identified in the audit report, status updates during the plans execution and a
copy of all final responses to the FDA. The Contractor shall also provide
redacted copies of any FDA audits received from subcontractors that occur as a
result of this contract or for this product. The Contractor shall make
arrangements for BARDA representative(s) to be present during the final debrief
by the regulatory inspector.

 

  —  

Contractor shall notify CO and COR within 10 business days of a scheduled FDA
audit or within 24 hours of an ad hoc site visit/audit if the FDA does not
provide advanced notice.

  —  

Contractor shall provide copies of any FDA audit report received from
subcontractors that occur as a result of this contract or for this product
within 3 business days of receiving correspondence from the FDA, Subcontractor,
or third party.

  —  

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

  iv. Manufacturing Campaign Reports

Contractor shall provide Manufacturing Campaign Reports to BARDA for review and
comment prior to submission to FDA.

The COR and CO reserve the right to request within the Period of Performance
(PoP) a non-proprietary Manufacturing Campaign Report for distribution within
the USG.

 

  —  

Contractor will submit Manufacturing Campaign Reports at least 15 business days
prior to FDA submission.

  —  

If corrective action is recommended, Contractor must address, in writing, all
concerns raised by BARDA.

  —  

Contractor shall consider revising reports to address BARDA’s concerns and/or
recommendations prior to FDA submission.

  —  

Final FDA submission shall be submitted to BARDA concurrently or no later than 1
business day after submission to the FDA.

 

  v. Other FDA Correspondence

The Contractor shall memorialize any correspondence between Contractor and FDA
and submit to BARDA. All documents shall be duly marked as either “Draft” or
“Final.” Contractor shall provide written summary of any FDA correspondence
within 3 business days of correspondence.

 

C. Earned Value Management (EVM) Deliverables

 

  i. Earned Value Management (EVM) / Contract Performance Report (CPR)

Contractor will provide a monthly CPR at an agreed upon reporting level using
WBS and Variance Analysis report formats agreed upon by BARDA.

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

 

27

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  —  

Contractor shall provide EVM/CPR as part of the Monthly Progress Report (this
requirement begins only as set forth in the Contract Milestones & Related
Deliverables table, see Attachment #10)

  —  

Contractor shall provide top level or key changes in baseline cost as a result
of anticipated cost savings or risks

  —  

BARDA may request, on a monthly or ad hoc basis that the Contractor provide raw
data at a reporting level or lower level as BARDA deems necessary.

  —  

Contractor must address, in writing, all concerns raised by BARDA.

  —  

Reporting will commence after the EVM system has been implemented but no later
than 12 months after start of base period.

 

  ii. Integrated Master Plan (IMP)

The Contractor shall provide an IMP including WBS, critical path milestones, and
Earned Value Management Plan

 

  —  

Contractor shall provide the draft IMP within [*] days of contract award with
final due [*] months after award and updated monthly as part of the Monthly
Progress Report

  —  

Contractor must address, in writing, all concerns raised by BARDA

 

  iii. Performance Measurement Baseline Review (PMBR)

PMBR Report shall address each of the items listed below and be cross-referenced
to the IMP, WBS, SOW, and Risk Management Plan.

 

  —  

Contractor provides baseline proposal

  —  

Responsibility Assignment Matrix

  —  

A description of the work scope through control account Work Authorization
Documents and/or WBS Dictionary down to the agreed upon control account level.

  —  

Template for work packages

  —  

Integrated Master Schedule (IMS) with the inclusion of agreed major milestones
and control account plans for all control accounts

  —  

Baseline revision documentation and program log(s) risk management plan

  —  

PMBR is due within 90 days of contract award

  —  

Contractor shall provide baseline proposal .ppt briefing 10 business days prior
to meeting

  —  

Contractor provides agenda to COR 2 business days in advance of meeting

  —  

COR approves (with CO concurrence) and distributes agenda

  —  

COR approves (with CO concurrence) all meeting material

  —  

Contactor provides minutes with 2 business days of the meeting

  —  

COR reviews and approves (with CO concurrence) minutes

  —  

BARDA will review documentation and provide written comments and questions to
Contractor

  —  

Contractor shall address BARDA’s comments and resubmit PMBR report for BARDA
approval within 10 business days.

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 

28

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  iv. Risk Management Plan

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

 

  ¡  

Due within 90 days of contract award

  ¡  

Contractor provides updated Risk Management Plan in Monthly Progress Report

  ¡  

BARDA shall provide Contractor with a written list of concerns in response plan
submitted

  ¡  

Contractor must address, in writing, all concerns raised by BARDA within 20
business days of Contractor’s receipt of BARDA’s concerns.

 

  v. Requirement for Notification of Deviation and Mitigation Strategy

Process for changing IMS activities associated with cost and schedule as
baselined at the PMBR. Contractor shall notify BARDA of significant changes to
the IMS defined as increases in cost above [*]% for Go/No Go Milestones or
schedule slippage of more than 30 days, which would require an extension to the
period of performance. Contractor shall provide a high level management strategy
for risk mitigation. Notice due within one (1) business day after discovery.

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 

29

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3.  Contract WBS Milestones & Related Deliverables

 

No.      Milestone Definition    Go Criteria    No-Go Criteria    Deliverable   

WBS/

SOW#

   CLIN # 1.    [*]    [*]    [*]    [*]   

1.5.1.1

 

1.5.1.2

  

Base

CLIN

0001

2.    [*]    [*]    [*]    [*]    1.5.1.3   

Base

CLIN

0001

3.    [*]    [*]    [*]    [*]   

1.3.2.3

 

1.3.2.4

  

Base

CLIN

0001

4.    [*]    [*]    [*]    [*]    1.4.1.2   

Base

CLIN

0001

5.    [*]    [*]    [*]    [*]    1.4.1.3   

Base

CLIN

0001

6.    [*]    [*]    [*]    [*]    2.4.1.1   

Option 1

CLIN

0002

7.    [*]    [*]    [*]    [*]    2.5.2.2   

Option 1

CLIN

0002

8.    [*]    [*]    [*]    [*]   

3.3.3.1

 

3.3.3.2

  

Option 2

CLIN

0003

9.    [*]    [*]    [*]    [*]    3.3.3.3   

Option 2

CLIN

0003

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 

30

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No.      Milestone Definition    Go Criteria    No-Go Criteria    Deliverable   

WBS/

SOW#

   CLIN # 10.    [*]    [*]    [*]    [*]    3.5.2.2   

Option 2

CLIN

0003

11.    [*]    [*]    [*]    [*]   

4.4.2.1

 

5.5.2.1

 

5.5.2.2

  

Option 3

CLIN

0004

12.    [*]    [*]    [*]    [*]    5.5.2.1   

Option 4

CLIN

0005

13.    [*]    [*]    [*]    [*]    5.5.2.2   

Option 4

CLIN

0005

* If at any time during the contract performance period any of the above No-Go
criteria are satisfied, the Government may conduct an In-Process-Review (IPR) to
evaluate whether to continue activities covered by the contract. This IPR will
may occur within [*] calendar days of the No-Go criteria being satisfied.

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 

31

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SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1. CONTRACTING OFFICER

The following Contracting Officer (CO) will represent the Government for the
purpose of this contract:

Susan Cortés-Shrank, Contracting Officer

DHHS/OS/ASPR/AMCG

330 Independence Avenue, S.W.

Room G640

Washington, D.C. 20201

E-mail:[*]

 

1) The Contracting Officer 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.

2) The Contracting Officer is the only person with the 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 reimburse to the Contractor of any costs incurred during
the performance of this contract; (5) otherwise change any terms and conditions
of this contract.

3) No information other than that which may be contained in an authorized
modification to this contract, duly issued by the Contracting Officer, which may
be received from any person employed by the US Government, other otherwise,
shall be considered grounds for deviation from any stipulation of this contract.

4) The Government may unilaterally change its COR designation.

The following Contract Specialist (CS) assigned to this contract is:

Susan Cortés-Shrank, Contracting Officer

DHHS/OS/ASPR/AMCG

330 Independence Avenue, S.W.

Room G640

Washington, D.C. 20201

E-mail: [*]

ARTICLE G.2. CONTRACTING OFFICER’S REPRESENTATIVE (COR)

The following Contracting Officer’s Representative (COR) will represent the
Government for the purpose of this contract:

[*]

Contracting Officer’s Representative (COR)

Biomedical Advanced Research and Development Authority (BARDA)

Office of the Assistant Secretary for Preparedness and Response (ASPR)

Department of Health and Human Services

Mailing Address:

330 Independence Avenue, SW Room G640

Washington, D.C. 20201

[*] (Office)

Email: [*]

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 

32

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Alternate COR:

[*]

Branch Chief – Broad Spectrum Antimicrobials

Division of CBRN Countermeasures

Biomedical Advanced Research & Development Authority (BARDA)

Office of Secretary for Preparedness & Response (ASPR)

Department of Health and Human Services

Mailing Address:

330 Independence Avenue, SW Room G640

Washington, D.C. 20201

Office: [*]

Email: [*]

The COR 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 in 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 COR designation.

ARTICLE G.3. KEY PERSONNEL

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

 

#       NAME    ORGANIZATION      TITLE 1       Prabha Fernandes, PhD    CEMPRA,
Inc.   

President and CEO/

Principal Investigator

2       Gary Horwith, MD    CEMPRA, Inc.    EVP of Regulatory Affairs 3      
David Oldach, MD, SVP    CEMPRA, Inc.    SVP of Clinical Research 4       David
Pereira, SVP    CEMPRA, Inc.    SVP of Chemistry 5       Lily Nguyen, MBA   
CEMPRA, Inc.    Director of Project Management 6       Shane Barton, CPA   
CEMPRA, Inc.    Corporate Controller

The key personnel specified in this contract are considered to be essential to
work performance. At least thirty (30) business days prior to diverting any of
the specified individuals to other programs or contracts, including, where
practicable, an instance when an individual must be replaced as a result of
leaving the employ of the Contractor, 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.

ARTICLE G.4. CONTRACT FINANCIAL REPORT

a. Financial reports on the attached Financial Report of Individual
Project/Contract (see Attachments 2 and 3) shall be submitted by the Contractor
in accordance with the instructions for completing this form, which accompany
the form, in an electronic copy, not later than the

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 

33

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30th business 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.

b. Unless otherwise stated in that part of the instructions for completing this
form, entitled “PREPARATION INSTRUCTIONS,” (see Attachment 4) all columns A
through J, shall be completed for each report submitted.

c. The first financial report shall cover the period consisting of the first
full 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.

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

e. 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.

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

ARTICLE G.5. INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORTING

 

1) The billing address that should be shown on the invoice shall be the same as
defined in ARTICLE G.2. of this contract as follows:

DHHS/OS/ASPR/AMCG

Attn: Susan Cortés-Shrank, Contracting Officer

330 Independence Ave., S.W.

Room G640

Washington, D.C. 20201

 

2) The Contractor shall submit an electronic copy of contract monthly
invoices/financial reports to the Contracting Officer and Contract Specialist as
defined above, in ARTICLE G of this contract.

 

3) Contractor invoices/financial reports shall conform to the form, format, and
content requirements of the instructions for Invoice/Financing requests and
Contract Financial Reporting made a part of the contract in Section J (See also
ARTICLE B.5. and Attachment 2).

 

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

 

5) The Contractor agrees to immediately notify the Contracting Officer in
writing if there is an anticipated overrun (any amount) or unexpended balance
(greater than 10 percent) of the estimated costs for the base segment or any
option segment(s) (See estimated costs under Articles B.2. and B.3., of the
contract) and the reasons for the variance. Also refer to the requirements of
the Limitation of Cost FAR 52.232-20 clause in the contract.

 

6) All invoice submissions shall be in accordance with FAR Clause 52.232-25
(c) in Section I of this contract.

 

34

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ARTICLE G.6. REIMBURSEMENT OF COST

 

1) The Government shall reimburse the Contractor the cost determined by the
Contracting Officer to be allowable (hereinafter referred to as allowable cost)
in accordance with the clause entitled Allowable Cost and Payment in Section I,
Contract Clauses, and FAR Subpart 31.7. Examples of allowable costs include, but
are not limited to, the following:

 

  a)

All direct materials and supplies that are used in the performing of the work
provided for under the contract, including those purchased for subcontracts and
purchase orders.

 

  b)

All direct labor, including supervisory, that is properly chargeable directly to
the contract, plus fringe benefits.

 

  c)

All other items of cost budgeted for and accepted in the negotiation of this
basic contract or modifications thereto.

 

  d)

Travel costs including per diem or actual subsistence for personnel while in an
actual travel status in direct performance of the work and services required
under this contract subject to the following:

 

  (i)

Air travel shall be by the most direct route using “air coach” or “air tourist”
(less than first class) unless it is clearly unreasonable or impractical (e.g.,
not available for reasons other than avoidable delay in making reservations,
would require circuitous routing or entail additional expense offsetting the
savings on fare, or would not make necessary connections).

 

  (ii)

Rail travel shall be by the most direct route, first class with lower berth or
nearest equivalent.

 

  (iii)

Costs incurred for lodging, meals, and incidental expenses shall be considered
reasonable and allowable to the extent that they comply with FAR 31.7.

 

  (iv)

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

ARTICLE G.7.  INDIRECT COST RATES

The following rates will be utilized for billing purposes during both the base
and option periods as provisional rates:

Fringe benefits at [*]% and an indirect rate estimated at [*]%.

ARTICLE G.8.  POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

1. 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.

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 

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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.

Copies of the evaluations, Contractor responses, and review comments, if any,
will be retained as part of the contract file, and may be used to support future
award decisions.

2. Electronic Access to Contractor Performance Evaluations

Contractors that have Internet capability may access evaluations through a
secure Web site for review and comment by completing the registration form that
can be obtained at the following address:

http://www.cpars.csd.disa.mil/cparsmain.htm

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 that will be responsible for notifying the
cognizant contracting official in the event the primary contact is unavailable
to process the evaluation within the required 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.

ARTICLE G.10. GOVERNMENT PROPERTY

1. 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, “Contractor’s Guide for Control of Government
Property,” which is incorporated into this contract by reference. This document
can be accessed at:

http://www.hhs.gov/hhsmanuals/          (HHS Logistics Management Manual)

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

2. Notwithstanding the provisions outlined in the HHS Publication, “Contractor’s
Guide for Control of Government Property,” which is incorporated in this
contract in paragraph 1. 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. This form is included as an attachment in SECTION J of this
contract.

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

ARTICLE G.11. EXERCISE OF OPTIONS

Unless the Government exercises its option pursuant to the Option Clause set
forth in Section I, Article I.2, the contract will consist only of CLIN 0001 of
the Statement of Work, Deliverables and Requirements as defined in Sections C, F
and J of the contract. Pursuant

 

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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.2, the Government may, by unilateral
contract modification, require the Contractor to perform the additional CLINs
listed in Section B, Article B.3., and as also defined in Sections C, F of this
contract. If the Government exercises an option, written notice must be given to
the Contractor within [*] days after the Government has completed its analysis
of the deliverables associated with the applicable GO/NO-GO Decision gates; and
the Government must give the Contractor a preliminary written notice of its
intent to exercise the option at least [*] days before the contract expires. The
amount of the contract may then be increased as set forth in Section B, Article
B.3 provided that funds are available.

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 

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SECTION H - SPECIAL CONTRACT REQUIREMENTS

If provisions set forth in this Section are not applicable to the work performed
directly by the Contractor, those provisions might still apply to subcontractors
performing work under this contract. It is the Contractor’s responsibility to
monitor their subcontractors to confirm that these provisions are satisfied.
Accordingly, those provisions shall be flowed-down as applicable.

ARTICLE H.1 CLINICAL AND NON-CLINICAL TERMS OF AWARD

BARDA has a responsibility to obtain documentation concerning mechanisms and
procedures that are in place to protect the safety of participants and animals
in BARDA funded clinical trials and non-clinical studies. Therefore, the
Contractor shall develop a protocol for each clinical trial and non-clinical
study funded under this contract and submit all such protocols and protocol
amendments to the BARDA Contracting Officer’s Representative (COR) for
evaluation and comment. Approval is required before work under a protocol may
begin. BARDA COR comments will be forwarded to the Contractor within ten
(10) business days. The Contractor must address, in writing, all concerns (e.g.
study design, safety, regulatory, ethical, and conflict of interest) noted by
the BARDA COR.

If the draft protocols are to be submitted to the FDA, BARDA review shall occur
before submission, pursuant to the terms set forth by ARTICLE F.2 of this
contract. The Contractor shall consider revising their protocols to address
BARDA’s concerns and recommendations prior to FDA submission. The Contractor
must provide BARDA with a copy of FDA submissions, within the time frame set
forth by ARTICLE F.2 of this contract.

Execution of clinical and non-clinical studies requires written authorization
from BARDA. The Government will provide written authorization to the Contractor
upon either 1) receiving documentation in which all COR comments have been
satisfactorily addressed; or 2) receiving documentation that the FDA has
reviewed and commented on the protocol.

BARDA shall have rights to all protocols, data resulting from execution of these
protocols, and final reports funded by BARDA under this contract, as set forth
in PART II of this contract and defined in the FAR. BARDA reserves the right to
request that the Awardee provide any contract deliverable in a non-proprietary
form to ensure BARDA has the ability to review and distribute the deliverables
as BARDA deems necessary.

Important information regarding performing human subject research is available
at http://www3.niaid.nih.gov/healthscience/clinicalstudies/.

Any updates to technical reports are to be addressed in the Monthly and Annual
Progress Reports. The Contractor shall advise the Contracting Officer’s
Representative or designee in writing and via electronic communication in a
timely manner of any issues potentially affecting contract performance.

 

  1. Non-Clinical Terms of Award

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

 

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  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 Institutional Animal Care and Use
Committees (IACUC) documentation of continuing review and approval and the
Office of Laboratory Animal Welfare (OLAW) federal wide assurance number for the
institution or site.

If other institutions are involved in the research (e.g., a multicenter trial or
study), each institution’s IACUC must review and approve the protocol. They must
also provide BARDA initial and annual documentation of continuing review and
approval and federal wide assurance number.

The Contractor must ensure that the application, as well as all protocols, are
reviewed by the performing institution’s IACUC.

To help ensure the safety of animals used in BARDA-funded studies, the
Contractor must provide 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 date it is valid.

 

  •  

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

 

  •  

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

 

  •  

Termination or temporary suspension of the protocol.

 

  •  

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

 

  •  

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 (5) working
days from the time the Contractor becomes aware of such changes 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.

 

39

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  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. FDA expects
non-clinical studies to include safety in addition to efficacy. Awardee should
consider evaluation of clinical relevant safety markers in the pivotal and
non-pivotal, non-clinical studies. In preparation for clinical trials of
licensed or not yet licensed products, it is imperative that BARDA-sponsored
studies of any type measure the risk and safety parameters that are elicited and
provide a safety profile from the studies for future human risk assessment.

A risk is minimal where the probability and magnitude of harm or discomfort
anticipated in the proposed research are not greater 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.

The Contractor shall inform BARDA of any upcoming site visits and/or audits of
CRO facilities funded under this effort. BARDA reserves the right to accompany
the Contractor on site visits and/or audits of CRO’s as BARDA deems necessary.

 

  b. BARDA Review Process before Non-Clinical study Execution Begins

BARDA is under the same policy-driven assurances as NIH in that it has a
responsibility to ensure that mechanisms and procedures are in place to protect
the safety and welfare of animals used in BARDA-funded non-clinical trials.
Therefore, before study execution, the Contractor must provide the following (as
applicable) for review and comment by 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 federal wide number, IACUC
registration number, and IACUC name.

 

  •  

Contractor should reduce the number of animals required for a study using power
of statistics.

 

  •  

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.

 

  •  

Purchasing of animals and/or other supplies for non-clinical studies funded in
part or in whole by BARDA requires written approval by the Contracting Officer
in accordance with the contract. The Contractor must have the ability to
return/re-sell animals, at purchase price, to distributor or a third part, in
the event that the final protocols do not obtain approval and a Contracting
Officer Authorization is not granted.

 

  •  

Provide justification for whether studies require good laboratory practice (GLP)
conditions.

 

  •  

Provide justification for whether studies will be classified as non-pivotal or
pivotal studies.

Documentation of each of the above items shall be submitted to BARDA for
evaluation and comment in conjunction with the protocol. Execution of
non-clinical studies requires written authorization from BARDA in accordance
with this section of the contract.

 

  c. References

Public Health Service Policy on Humane Care and Use of Laboratory Animals:

http://grants.nih.gov/grants/olaw/InvestigatorsNeed2Know.pdf

USDA Animal Welfare Act:

http://awic.nal.usda.gov/nal_display/index.php?info_center=3&tax_level=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.

Draft protocols for each clinical study will be submitted to BARDA for
evaluation and comment. BARDA comments will be addressed and/or incorporated
into the draft protocol prior to submission to the FDA for comment, if required.

BARDA shall have rights to all protocols, data generated from the execution of
these protocols, and final reports, funded by BARDA under this contract, as
defined in Rights in Data Clause in FAR 52.227-14. BARDA reserves the right to
request that the Contractor provide any contract deliverable in a
non-proprietary form, to ensure BARDA has the ability to review and distribute
the deliverables, as BARDA deems necessary.

 

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  i. 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 federal
wide assurance number for the institution or site.

If other institutions are involved in the research (e.g., a multicenter clinical
trial or study), each institution’s IRB or IEC must review and approve the
protocol. They must also provide BARDA initial and annual documentation of
continuing review and approval, including the current approved informed consent
document and federal wide number.

The Contractor must ensure that the application as well as all protocols are
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 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 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 BARDA through the COR or CO of any of the above
changes within five (5) 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 from 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

 

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(DSMB); other trials may require DSMB oversight as well. The Contractor shall
inform BARDA of any upcoming site visits and/or audits of CRO facilities funded
under this effort. BARDA reserves the right to accompany the Contractor on site
visits and/or audits of CROs as BARDA deems necessary. The Contractor shall
inform BARDA 30 days in advance of a DSMB board meetings for studies funded
under this effort. BARDA reserves the right to participate in the DSMB board
meetings on an impromptu basis as a non-voting member.

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).

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 thirty (30) days of
reviews or meetings.

 

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  ii. BARDA Protocol Review Process Before Patient Enrollment Begins

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

 

  —  

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 federal wide 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 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.

Documentation to demonstrate that each of the above items are in place shall be
submitted to the BARDA) for evaluation and comment in conjunction with the
protocol. Execution of clinical studies requires written authorization from
BARDA in accordance with this section of this contract.

 

  iii. Investigational New drug or Investigational Device 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 from FDA, and
the written responses to those comments.

Unless FDA notifies Contractor otherwise, The Contractor must wait thirty
(30) calendar days from FDA receipt of an initial IND or IDE application before
initiating a clinical trial.

The Contractor must notify 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.

 

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The Contractor must not use grant or contract funds during a clinical hold to
fund the clinical studies that are on hold. The Contractor must not enter into
any new financial obligations related to clinical activities for the clinical
trial on clinical hold.

 

  iv. 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 representative or the Contracting Officer’s
Representative (COR) as follows:

• 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 (7) days after the
IND sponsor’s receipt of the information, must be submitted to BARDA
representative or COR within 24 hours of FDA notification.

• Expedited safety reports of serious and unexpected adverse experiences:

A copy of any report of unexpected and serious adverse experience associated
with use of an IND drug or any finding from tests in laboratory animals that
suggests a significant risk for human subjects, which must be reported in
writing to FDA as soon as possible but no later than 15 day after the IND
sponsor’s receipt of the information, must be submitted to the BARDA
representative or COR 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 BARDA representative or COR within 24 hours of FDA
notification.

• Expedited safety reports:

Sent to BARDA representative or the COR 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 BARDA annually.

In case of problems or issues, the BARDA representative or the Contracting
Officer’s Representative will contact the Contractor within ten (10) working
days by email or fax, followed within thirty (30) calendar days by an official
letter to the Contractor’s Project Manager, with a copy to the institutions’
office of sponsored programs, listing issues 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 Representative and the Contractor.

 

45

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ARTICLE H.2. 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), Department of Health and Human
Services. The Contractor further agrees to provide certification at least
annually that the Institutional Review Board has reviewed and approved the
procedures, which involve human subjects in accordance with 45 CFR Part 46 and
the Assurance of Compliance.

(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. The
Contractor shall not deem anything in this contract 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 OHRP 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. The Contracting Officer may communicate the notice
of suspension by telephone with confirmation in writing. If the Contractor fails
to complete corrective action within the period of time designated in the
Contracting Officer’s written notice of suspension, the Contracting Officer may,
after consultation with OHRP, terminate this contract in whole or in part, and
the Contractor’s name may be removed from the list of those contractors with
approved Human Subject Assurances.

ARTICLE H.3. HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE)

The acquisition and supply of all human specimen material (including fetal
material) used under this contract shall be obtained by the Contractor in full
compliance with 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).

 

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ARTICLE H.4. RESEARCH INVOLVING HUMAN FETAL TISSUE

All research involving human fetal tissue shall be conducted in accordance with
the Public Health Service Act, 42 U.S.C. 289g-1 and 289g-2. Implementing
regulations and 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.5. 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.6. CARE OF LIVE VERTEBRATE ANIMALS, HHSAR 352.270-5 (October 2009)

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

(c) The Contractor agrees that the care, use and intended use of any live
vertebrate animals in the performance of this contract shall conform with the
Public Health Service (PHS) Policy on Humane Care of Use of Laboratory Animals
(PHS Policy), the current Animal Welfare Assurance (Assurance), the Guide for
the Care and Use of Laboratory Animals (National Academy Press, Washington, DC)
and the pertinent laws 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 govern.

(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 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 Assurances.

Note: The Contractor may request registration of its facility and a current
listing of licensed dealers from the Regional Office of the Animal and Plant
Health Inspection Service (APHIS), USDA, for the region in which its research
facility is located. The location of the appropriate APHIS Regional Office, as
well as information concerning this program may be obtained by contacting the
Animal Care Staff, USDA/APHIS, 4700 River Road, Riverdale, Maryland 20737
(E-mail: ace@aphis.usda.gov; Web site:
(http://www.aphis.usda.gov/animal_welfare).

 

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ARTICLE H.7. 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.8. 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.9. PUBLICATION AND PUBLICITY

No information related to data obtained under this contract shall be released or
publicized without the prior written consent of BARDA.

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, Section 507 of P.L. 104-208 mandates that Contractors funded with
Federal dollars, in whole or in part, acknowledge Federal funding when issuing
statements, press releases, requests for proposals, bid solicitations and other
documents. Contractors are required to state: (1) the percentage and dollar
amounts of the total program or project costs financed with Federal money and;
(2) the percentage and dollar amount of the total costs financed by
nongovernmental sources.

For purposes of this contract “publication” is defined as an issue of printed
material offered for distribution or any communication or oral presentation of
information, including any manuscript or scientific meeting abstract. Any
publication containing data generated under this contract must be submitted for
BARDA review no less than thirty (30) calendar days for manuscripts and fifteen
(15) calendar days for abstracts before submission for public presentation or
publication. Contract support shall be acknowledged in all such publications
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. HHSO100201300009C”.

ARTICLE H.10. 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 CO/COR has received an
advance copy of any press release related to the contract not less than five
(5) working days prior to the issuance of the press release.

 

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The Contractor shall acknowledge the support of the Department of Health and
Human Service, Office of the Assistant Secretary for Preparedness and Response,
Biomedical Advanced Research and Development Authority, whenever publicizing the
work under this contract in any media by including an acknowledgment
substantially as follows:

“This project has been funded in whole or in part with Federal funds from the
Department of Health and Human Services; Office of the Assistant Secretary for
Preparedness and Response; Biomedical Advanced Research and Development
Authority, under Contract No HHSO100201300009C.

ARTICLE H.11. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

Anyone who becomes aware of the existence or apparent existence of fraud, waste
and abuse in BARDA 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.12. 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.

ARTICLE H.13. 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.

 

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ARTICLE H.14. 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 10, 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 352.203-70 “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.

ARTICLE H.15. PRIVACY ACT APPLICABILITY

 

1) Notification is hereby given that the Contractor and its employees are
subject to criminal penalties for violation of the Privacy Act to the same
extent as employees of the Government. The Contractor shall assure that each of
its employees knows the prescribed rules of conduct and that each is aware that
he or she can be subjected to criminal penalty for violation of the Act. A copy
of 45 CFR Part 5b, Privacy Act Regulations, may be obtained at
http://www.gpoaccess.gov/cfr/index.html

 

2) The Project Officer is hereby designated as the official who is responsible
for monitoring contractor compliance with the Privacy Act.

 

3) The Contractor shall follow the Privacy Act guidance as contained in the
Privacy Act System of Records number 09-25-0200. This document may be obtained
at the following link: http://oma.od.nih.gov/ms/privacy/pa-files/0200.htm

ARTICLE H.16.    LABORATORY LICENSE REQUIREMENTS

The Contractor shall comply with all applicable requirements of Section 353 of
the Public Health Service Act (Clinical Laboratory Improvement Act as amended).
This requirement shall also be included in any subcontract for services under
the contract.

 

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ARTICLE H.17.    DISSEMINATION OF INFORMATION (May 1998)

No information related to data obtained under this contract shall be released or
publicized without the prior written consent of the Contracting Officer.

ARTICLE H.18.    IDENTIFICATION AND DISPOSITION OF DATA

The Contractor will be required to ensure that certain data generated under this
contract is provided to the Department of Health and Human Services (DHHS). DHHS
reserves the right to review any other data determined by DHHS to have been
generated under this contract. The Contractor shall ensure that copies of all
data required by the Food and Drug Administration (FDA) relevant to this
contract are kept for the time specified by the FDA.

ARTICLE H.19.    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.

ARTICLE H.20. REQUIREMENTS FOR ADEQUATE ASSURANCE OF PROTECTION OF VERTEBRATE
ANIMAL SUBJECTS

The PHS Policy on Humane Care and Use of Laboratory Animals requires that
applicant organizations proposing to use vertebrate animals file a written
Animal Welfare Assurance with the Office for Laboratory Animal Welfare (OLAW),
establishing appropriate policies and procedures to ensure the humane care and
use of live vertebrate animals involved in research activities supported by the
PHS. The PHS Policy stipulates that an applicant organization, whether domestic
or foreign, bears responsibility for the humane care and use of animals in
PHS-supported research activities. Also, the PHS policy defines “animal” as “any
live, vertebrate animal used, or intended for use, in research, research
training, experimentation, biological testing or for related purposes.” This
Policy implements and supplements the U.S. Government

 

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Principles for the Utilization and Care of Vertebrate Animals Used in Testing,
Research, and Training, and requires that institutions use the Guide for the
Care and Use of Laboratory Animals as a basis for developing and implementing an
institutional animal care and use program. This Policy does not affect
applicable State or local laws or regulations that impose more stringent
standards for the care and use of laboratory animals. All institutions are
required to comply, as applicable, with the Animal Welfare Act as amended (7 USC
2131 et. seq.) and other Federal statutes and regulations relating to animals.
These documents are available from the Office of Laboratory Animal Welfare,
National Institutes of Health, Bethesda, MD 20892, (301) 496-7163. See
http://grants.nih.gov/grants/olaw/olaw.htm.

No PHS supported work for research involving vertebrate animals will be
conducted by an organization, unless that organization is operating in
accordance with an approved Animal Welfare Assurance and provides verification
that the Institutional Animal Care and Use Committee (IACUC) has reviewed and
approved the proposed activity in accordance with the PHS policy. Applications
may be referred by the PHS back to the institution for further review in the
case of apparent or potential violations of the PHS Policy. No award to an
individual will be made unless that individual is affiliated with an assured
organization that accepts responsibility for compliance with the PHS Policy.
Foreign applicant organizations applying for PHS awards for activities involving
vertebrate animals are required to comply with PHS Policy or provide evidence
that acceptable standards for the humane care and use of animals will be met.
Foreign applicant organizations are not required to submit IACUC approval, but
should provide information that is satisfactory to the Government to provide
assurances for the humane care of such animals.

ARTICLE H.21. 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.22. REGISTRATION WITH THE SELECT AGENT PROGRAM FOR WORK INVOLVING THE
POSSESSION, USE, AND/OR TRANSFER OF SELECT BIOLOGICAL AGENTS OR TOXINS

Work involving select biological agents or toxins shall not be conducted under
this contract until the Contractor and any affected subcontractor(s) are granted
a certificate of registration or are authorized to work with the applicable
select agents.

For prime or subcontract awards to domestic institutions who possess, use,
and/or transfer Select Agents under this contract, the institution must complete
registration with the Centers for Disease Control and Prevention (CDC),
Department of Health and Human Services (DHHS) or the Animal and Plant Health
Inspection Services (APHIS), U.S. Department of Agriculture (USDA), as
applicable, before performing work involving Select Agents, in accordance with
42 CFR 73. No Government funds can be used for work involving Select Agents, as
defined in 42 CFR 73, if the final registration certificate is denied.

 

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For prime or subcontract awards to foreign institutions who possess, use, and/or
transfer Select Agents under this contract, the institution must provide
information satisfactory to the Government that a process equivalent to that
described in 42 CFR 73 (http://www.cdc.gov/od/sap/docs/42cfr73.pdf) for U.S.
institutions is in place and will be administered on behalf of all Select Agent
work sponsored by these funds before using these funds for any work directly
involving the Select Agents. The Contractor must provide information addressing
the following key elements appropriate for the foreign institution: safety,
security, training, procedures for ensuring that only approved/appropriate
individuals have access to the Select Agents, and any applicable laws,
regulations and policies equivalent to 42 CFR 73. The Government will assess the
policies and procedures for comparability to the U.S. requirements described in
42 CFR Part 73. When requested by the contracting officer, the Contractor shall
provide key information delineating any laws, regulations, policies, and
procedures applicable to the foreign institution for the safe and secure
possession, use, and transfer of Select Agents. This includes summaries of
safety, security, and training plans, and applicable laws, regulations, and
policies. For the purpose of security risk assessments, the Contractor must
provide the names of all individuals at the foreign institution who will have
access to the Select Agents and procedures for ensuring that only approved and
appropriate individuals have access to Select Agents under the contract.

Listings of HHS select agents and toxins, biologic agents and toxins, and
overlap agents or toxins as well as information about the registration process,
can be obtained on the Select Agent Program Web site at
http://www.cdc.gov/od/sap/.

ARTICLE H.23. EPA ENERGY STAR REQUIREMENTS

In compliance with Executive Order 12845 (requiring Agencies to purchase energy
efficient computer equipment) all microcomputers, including personal computers,
monitors, and printers that are purchased using Government funds in performance
of a contract shall be equipped with or meet the energy efficient low-power
standby feature as defined by the EPA Energy Star program unless the equipment
always meets EPA Energy Star efficiency levels. The microcomputer, as configured
with all components, must be Energy Star compliant.

This low-power feature must already be activated when the computer equipment is
delivered to the agency and be of equivalent functionality of similar power
managed models. If the equipment will be used on a local area network, the
vendor must provide equipment that is fully compatible with the network
environment. In addition, the equipment will run commercial off-the-shelf
software both before and after recovery from its energy conservation mode.

ARTICLE H.24.  MANUFACTURING STANDARDS

The Good Manufacturing Practice Regulations (GMP)(21 CFR Parts 210-211) and
regulations pertaining to small molecules will be the standard to be applied for
manufacturing, processing, packaging, storage and delivery of this product.

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

 

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ARTICLE H.25. 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.26. 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

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.

 

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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.

ARTICLE H.27 NOTIFICATION OF CRITICAL PROGRAMMATIC CONCERNS, RISKS, OR POTENTIAL
RISKS

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

 

  —  

Within 48 hours of activity or incident or within 24 hours for a security
related activity or incident, Contractor must notify BARDA.

  —  

Additional updates due to COR and CO within 48 hours of additional developments.

  —  

Contractor shall submit within 5 business days a Corrective Action Plan (if
deemed necessary by either party) to address any potential issues.

If corrective action is deemed necessary, Contractor must address in writing,
its consideration of concerns raised by BARDA within 5 business days.

 

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PART II - CONTRACT CLAUSES

SECTION I - CONTRACT CLAUSES

ARTICLE I.1.   FAR 52.252-2, CLAUSES INCORPORATED BY REFERENCE (FEBRUARY 1998)

This contract incorporates the following clauses by reference, with the same
force 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: https://www.acquisition.gov/

General Clauses for Cost-Reimbursement Research and Development Contract

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

 

FAR
CLAUSE NO.   DATE    TITLE 52.202-1   Jan 2012    Definitions 52.203-3  
Apr 1984    Gratuities 52.203-5   Apr 1984    Covenant Against Contingent Fees
52.203-6   Sep 2006    Restrictions on Subcontractor Sales to the Government
52.203-7   Oct 2010    Anti-Kickback Procedures 52.203-8   Jan 1997   
Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity
52.203-10   Jan 1997    Price or Fee Adjustment for Illegal or Improper Activity
52.203-12   Oct 2010    Limitation on Payments to Influence Certain Federal
Transactions (Over $150,000) 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
  May 2011    Printed or Copied Double-Sided on Recycled Paper 52.204-7   Dec
2012    Central Contractor Registration 52.204-10   Aug 2012    Reporting
Executive Compensation and First-Tier Subcontract Awards ($25,000 or more)
52.204-13   Dec 2012    Central Contractor Registration Maintenance 52.209-6  
Dec 2010    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 52.215-8   Oct 1997   
Order of Precedence - Uniform Contract Format 52.215-10    Aug 2011    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 52.215-15   Oct 2010    Pension Adjustments and
Asset Reversions 52.215-17   Oct 1997    Waiver of Facilities Capital Cost of
Money 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) 52.216-7   Jun 2011    Allowable Cost and Payment

 

56

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FAR
CLAUSE NO.   DATE    TITLE 52.216-8   Jun 2011    Fixed Fee 52.216-12   Apr 1984
   Cost Sharing Contract – no fee 52.217-9   Mar 2000   

Option to Extend the Term of the Contract

 

(a) The Government may extend the term of this contract by written notice to the
Contractor within          [insert the period of time within which the
Contracting Officer may exercise the option]; provided that the Government gives
the Contractor a preliminary written notice of its intent to extend at least 30
days before the contract expires. The preliminary notice does not commit the
Government to an extension.

 

(b) If the Government exercises this option, the extended contract shall be
considered 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.

52.219-16   Jan 1999    Liquidated Damages - Subcontracting Plan 52.222-2   Jul
1990    Payment for Overtime Premiums 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) 52.222-40   Dec 2010    Notification of Employee Rights Under the
National Labor Relations Act 52.222-50   Feb 2009    Combating Trafficking in
Persons 52.222-54   Jan 2009    Employment Eligibility Verification 52.223-6  
May 2001    Drug-Free Workplace 52.223-18   Aug 2011    Encouraging Contractor
Policy to Ban Text Messaging While Driving 52.224-1   April 1984    Privacy Act
Notification 52.224-2   April 1984    Privacy Act 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 52.227-3   Apr 1984    Patent Indemnity 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.

 

57

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FAR
CLAUSE NO.   DATE    TITLE 52.227-14   Dec 2007   

Rights in Data – General, Alternate II.

 

Completed portion as follows:

 

Limited Rights Notice (Dec 2007)

 

(a) These data are submitted with limited rights under Government Contract No.
HHSO10020XX000XXX (and subcontract         , if appropriate). These data may be
reproduced and used by the Government with the express limitation that they will
not, without written permission of the Contractor, be used for purposes of
manufacture nor disclosed outside the Government; except that the Government may
disclose these data outside the Government for the following purposes, provided
that the Government makes such disclosure subject to prohibition against further
use and disclosure:

 

(i) Use (except for manufacture) by support service contractors.

(ii) Evaluation by nongovernment evaluators.

 

(b) This Notice shall be marked on any reproduction of these data, in whole or
in part.

52.227-16   Jun 1987    Additional Data Requirements 52.232-9   Apr 1984   
Limitation on Withholding of Payments 52.232-17   Oct 2010    Interest 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 52.242-15   Aug 1989    Stop Work Order. Alt I (Aug 1984)
52.243-2   Aug 1987    Changes - Cost Reimbursement, Alternate V (Apr 1984)
52.244-2   Oct 2010    Subcontracts, Alternate I (June 2007) 52.244-5   Dec 1996
   Competition in Subcontracting 52.244-6   Dec 2010    Subcontracts for
Commercial Items

52.245-1

Alt. II

  Aug 2010    Government Property, Alternate II (Jun 2007) 52.245-9   Aug 2010
   Use and Charges 52.246-9   Apr 1984    Inspection of Research and Development
(Short Form) 52.246-23   Feb 1997    Limitation of Liability 52.247-63   Jun
2003    Preference for U.S.-Flag Air Carriers 52.249-6   May 2004    Termination
(Cost-Reimbursement) 52.249-14   Apr 1984    Excusable Delays 52.253-1  
Jan 1991    Computer Generated Forms

 

58

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

 

HHSAR
CLAUSE NO.   DATE    TITLE 352.202-1   Jan 2006    Definitions - with Alternate
paragraph (h) (Jan 2006) 352.203-70   Mar 2012    Anti-Lobbying 352.216-70   Jan
2006    Additional Cost Principles 352.222-70   Jan 2010    Contractor
Cooperation in Equal Employment Opportunity Investigations 352.223-70   Jan 2006
   Safety and Health 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 352.231-70*   Aug 2012    Salary Rate Limitation 352.231-71   Jan
2001    Pricing of adjustments 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
352.270-4   Jan 2006    Protection of Human Subjects 352.270-6   Jan 2006   
Restriction on use of Human Subjects

* The provisions set forth by this clause will only apply if and when any funds
are obligated from HHS funding appropriated in the 2012 government fiscal year.

[End of GENERAL CLAUSES FOR A NEGOTIATED COST-REIMBURSEMENT RESEARCH AND
DEVELOPMENT CONTRACT-Rev. 12/2011].

ARTICLE I.2. 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:

a.   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 [*] days after the Government has completed its analysis of
the deliverables associated with the applicable GO/NO GO Decision gate; provided
that the Government gives the Contractor a preliminary written notice of its
intent to extend at least [*] days before the contract expires. The preliminary
notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be
considered to include this option clause.

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

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 

59

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(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:

(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

 

60

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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, [ ] 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].

 

61

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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

Statement of Work, dated 22 April 2013.

2. Invoice/Financing Request Instructions and Contract Financial Reporting
Instructions for BARDA Cost-Reimbursement Type Contracts,

Invoice/Financing Request Instructions and Contract Financial Reporting
Instructions for BARDA Cost-Reimbursement Type Contracts, 5 pages.

3. Financial Report of Individual Project/Contract, 1 page

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

5. Inclusion Enrollment Report

Inclusion Enrollment Report, 5/01 (Modified OAMP: 10/01), 1 page.

6. Research Patient Care Costs

Research Patient Care Costs, 1 page.

7. Report of Government Owned, Contractor Held Property

Report of Government Owned, Contractor Held Property, 1 page. Located at:
http://rcb.cancer.gov/rcb-internet/forms/Govt-Owned-Prop.pdf

8. 7 Principles of Earned Value Management Tier 2 System Implementation Guide

 

62

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PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

The following documents are incorporated by reference in this contract:

 

1) Representations & Certifications - Status Active on SAM.gov.

 

2) Final Cost Proposal Budget received 26 March 2013.

 

3) Final Technical Proposal received 22 April 2013.

 

4) Human Subjects Assurance Identification Numbers:

 i.      Duke Clinical Research Institute (DCRI): 00009025

ii.      Celerion: FWA00003049

 

5) Animal Welfare Assurance Numbers (OLAW/PHS):

 i.      Lovelace: A3083-01

ii.      MPI Research: A3181-01

 

63

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3. STATEMENT OF WORK

 

3.1 Preamble

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 CBRN BAA-12-100-SOL-00011.

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.

 

3.2 Overall Objectives and Scope

The overall objective of this contract is to advance the development of
solithromycin (SOLI) as an intravenous (IV) and orally-delivered antibiotic for
use in the pediatric population for the treatment of community-acquired
bacterial pneumonia (CABP) and for protection against biothreat organisms,
including Bacillus anthracis and Francisella tularensis. The scope of work is
organized in 5 severable phases (Clinical Line Item Number [CLIN] 1 through 5):

 

LOGO [g539986ex10_15pg064.jpg]

 

64

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1. CLIN 1

The Contractor will carry out the following tasks and subtasks and in accordance
with the agreed upon Integrated Master Schedule and Integrated Master Plan,
which further details the conduct of the specific tasks and subtasks.

 

1.1 Program Management (WBS 1.1)

The Contractor outsources a majority of the work to established practitioners in
each discipline, with the Contractor team providing experienced program
management, coordination, and oversight. All selected purchased commercial
service providers for the BARDA project have proven their ability to deliver
quality work cost-effectively and on schedule. The Contractor shall provide for
the following program management activities as outlined below:

 

  1.1.1 The Contractor will provide overall management, integration and
coordination of all contract activities, including a technical and
administrative infrastructure to ensure the efficient planning, initiation,
implementation, and direction of all contract activities.

 

  1.1.2 The Principal Investigator is responsible for overall leadership for
project management, communication, tracking, monitoring and reporting on status
and progress, and modification to the project requirements and timelines,
including projects undertaken by subcontractors.

 

  1.1.3 The Project Manager will oversee the monitoring and tracking day-to-day
progress and timelines, coordinating communication and project activities; costs
incurred; and program management.

 

  1.1.4 The Principal Investigator and the Project Manager will act as the BARDA
Liaison with responsibility for effective communication with the Project Officer
and Contracting Officer.

 

  1.1.5 The Contractor has adequate administrative staff and legal consultants
to provide development of compliant subcontracts, consulting, and other legal
agreements, and ensure timely acquisition of all proprietary rights, including
IP rights, and reporting all inventions made in the performance of the project.

 

  1.1.6 The Contractor’s Project Management Team along with support from the
Finance department has responsibility for financial management and reporting on
all activities conducted by the Contractor and any subcontractors and service
providers.

 

  1.1.7 Contract Review Meetings

 

  1.1.7.1 The Contractor’s team will participate in regular face-to-face
meetings on a quarterly basis to coordinate and oversee the contract effort as
directed by the Contracting and Project Officers. Such meetings may include, but
are not limited to, meeting of the Contractor and subcontractors to discuss
clinical manufacturing progress, product development, product assay development,
scale up manufacturing development, clinical sample assays development,
preclinical/clinical study designs and regulatory issues; meetings with
individual Contractors and other HHS officials to discuss the technical,
regulatory, and ethical aspects of the program; and meeting with technical
consultants to discuss technical data provided by the Contractor.

 

  1.1.7.2 The Contractor will participate in teleconferences every 2 weeks
between the Contractor and BARDA to review technical progress. The Contractor
will include subcontractors and service providers as necessary. If additional
teleconferences or face-to-face meetings are requested by BARDA, the Contractor
will be available.

 

  1.1.8 Integrated Master Schedule (IMS)

1.1.8.1 Within 30 calendar days of the effective date of the contract, the
Contractor will submit a first draft of an updated IMS in a format agreed upon
by BARDA to the Project Officer and the Contracting Officer for review and
comment. The Integrated Master Schedule will be incorporated into the contract,
and will be used to monitor performance of the contract. The Contractor will
include the key milestones and Go/No Go decision gates. The IMS for the period
of performance will be reviewed and accepted by BARDA at the PMBR.

 

  1.1.9 Integrated Master Plan (IMP)

 

  1.1.9.1

Work Breakdown Structure: The Contractor will utilize a WBS template agreed upon
by BARDA for reporting on the contact. The Contractor will expand and delineate
the Contract Work

 

65

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Breakdown Structure (CWBS) to a level agreed upon by BARDA as part of their
Integrated Master Plan for contract reporting. The CWBS will be discernible and
consistent. At BARDA’s request, the Contractor will furnish WBS data at the work
package level or at a lower level if there is significant complexity and risk
associated with the task.

 

  1.1.9.2 GO/ NO-GO Decision Gates/Contract Milestones: The IMP will outline key
milestones with “Go/No Go” decision criteria (entrance and exit criteria for
each phase of the project). The project plan should include, but not be limited
to, milestones in manufacturing, non-clinical and clinical studies, and
regulatory submissions.

 

  1.1.9.3 Earned Value Management System Plan: Subject to the requirements under
HHSAR Clause 352.234-4, the Contractor will use principles of Earned Value
Management System (EVMS) in the management of this contract. The Contractor will
follow the Seven Principles:

 

  I. The Contractor will plan all work scope for the program to completion.

 

  II. The Contractor will 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.

 

  III. The Contractor will integrate program work scope, schedule, and cost
objectives into a performance measurement baseline plan against which
accomplishments may be measured.

 

  IV. The Contractor will use actual cost incurred and recorded in accomplishing
the work performed.

 

  V. The Contractor will objectively assess accomplishments at the work
performance level.

 

  VI. The Contractor will analyze significant variances from the plan, forecast
impacts, and prepare an estimate at completion based on performance to date and
work to be performed.

 

  VII. The Contractor will use earned value information in the company’s
management processes.

We understand that elements of EVMS will be applied to all applicable projects
as part of the IMP. In addition, the Contractor will submit a written summary of
the management procedures that will be used to establish, maintain and comply
with EVMS requirements.

 

  1.1.10 Decision Gate Reporting: On completion of a stage of the product
development, as defined in the agreed upon IMS and IMP, the Contractor will
prepare and submit to the Project Officer and the Contracting Officer a Decision
Gate Report that contains (i) sufficient detail, documentation and analysis to
support successful completion of the stage according to the predetermined
qualitative and quantitative criteria that were established for Go/No Go
decision making; and (ii) a description of the next stage of product development
to be initiated and a request for approval to proceed to the next stage of
product development.

 

  1.1.11 Risk Management Plan: The Contractor will develop a risk management
plan within 90 days of contract award highlighting potential problems and/or
issues that may arise during the life of the contract, their impact on cost,
schedule and performance, and appropriate remediation plans. This plan will
reference relevant WBS elements where appropriate. Updates to this plan will be
included every 3 months (quarterly) in the monthly Project Status Report.

 

  1.1.12 Performance Measurement Baseline Review (PMBR): The Contractor will
submit a plan for a PMBR to occur within [*] days of contract award. At the
PMBR, the Contractor and BARDA will mutually agree upon the budget, schedule and
technical plan baselines (Performance Measurement Baseline). These baselines
will be the basis for monitoring and reporting progress throughout the life of
the contract. The PMBR is conducted to achieve confidence that the baselines
accurately capture the entire technical scope of work, are consistent with
contract schedule requirements, are reasonably and logically planned, and have
adequate resources assigned. The goals of the PMBR are as follows:

 

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

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 

66

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  II. Confirm the integrity of the Performance Measurement Baseline (PMB)

 

  III. Foster the use of EVM as a means of communication

 

  IV. Provide confidence in the validity of the Contractor’s reporting

 

  V. Identify risks associated with the PMB

 

  VI. Present any revised PMBs for mutual agreement

 

  VII. Present an IMS: The Contractor will deliver an initial program IMS that
rolls up all time-phased WBS elements down to the activity level. This IMS will
include the dependencies that exist between tasks. This IMS will be agreed to
and finalized at the PMBR.

 

  VIII. Present the Risk Management Plan

 

  1.1.13 Deviation Request: During the course of contract performance, in
response to a need to change IMS activities as baselined at the PMBR, the
Contractor will submit a Deviation Report. This report will be used to request a
change in the agreed-upon IMS and timelines, if necessary. This report will
include: (i) discussion of the justification/rationale for the proposed change;
(ii) options for addressing the needed changes from the agreed upon timelines,
including a cost-benefit analysis of each option; and (iii) recommendations for
the preferred option that includes a full analysis and discussion of the effect
of the change on the entire product development program, timelines, and budget.

 

  1.1.14 Monthly and Annual Reports: The Contractor will deliver Project Status
Reports on a monthly basis. The reports will address the items below cross
referenced to the WBS, SOW, IMS, and EVMS:

 

  I. Executive summary highlighting the progress, issues, and relevant
activities in manufacturing, non-clinical, clinical, and regulatory;

 

  II. Progress in meeting contract milestones, detailing the planned progress
and actual progress during the reporting period, explaining any differences
between the two and corrective steps;

 

  III. Updated IMS;

 

  IV. Updated EVMS;

 

  V. Updated Risk Management Plan (Every 3 months);

 

  VI. Three month rolling forecast of planned activities;

 

  VII. Progress of regulatory submissions;

 

  VIII. Estimated and actual expenses;

 

  1.1.15 Data Management: The Contractor will develop and implement data
management and quality control systems/procedures, including transmission,
storage, confidentiality, and retrieval of all contract data;

 

  1.1.15.1 Provide for the statistical design and analysis of data resulting
from the research;

 

  1.1.15.2 Provide raw data or specific analyses of data generated with contract
funding to the Project Officer, upon request.

 

1.2 [*] (WBS 1.2)

 

  1.2.1 [*] (WBS 1.2.1 - reserved)

 

  1.2.2 [*] (WBS 1.2.2)

 

  1.2.2.1 [*]

 

  1.2.2.2 [*]

 

1.3 [*] (WBS 1.3)

 

  1.3.1 [*] (WBS 1.3.1 - reserved)

 

  1.3.2 [*] (WBS 1.3.2)

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 

67

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  1.3.2.1 [*]

 

  1.3.2.2 [*]

 

  1.3.2.3 [*]

 

  1.3.2.4 [*]

 

  1.3.2.5 [*]

 

  1.3.3 [*] (WBS 1.3.3 - reserved)

 

1.4 [*] (WBS 1.4)

 

  1.4.1 [*] (WBS 1.4.1)

 

  1.4.1.1 [*]

 

  1.4.1.2 [*]

 

  1.4.1.3 [*]

 

  1.4.1.4 [*]

 

  1.4.2 [*] (WBS 1.4.2 - reserved)

 

1.5 [*] (WBS 1.5)

 

  1.5.1 [*] (WBS 1.5.1)

 

  1.5.1.1 [*]

 

  1.5.1.2 [*]

 

  1.5.1.3 [*]

 

  1.5.1.4 [*]

 

  1.5.2 [*] (WBS 1.5.2)

 

  1.5.2.1 [*]

 

  1.5.2.2 [*]

 

  1.5.2.3 [*]

 

  1.5.2.4 [*]

 

  1.5.2.5 [*]

 

1.6 [*] (WBS 1.6)

 

  1.6.1 [*] (WBS 1.6.1)

 

  1.6.1.1 [*]

 

  1.6.1.2 [*]

 

  1.6.1.3 [*]

 

  1.6.1.4 [*]

 

  1.6.2 [*] (WBS 1.6.2)

 

  1.6.2.1 [*]

 

  1.6.3 [*] (WBS 1.6.3)

 

  1.6.3.1 [*]

 

  1.6.3.2 [*]

 

  1.6.3.4 [*]

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 

68

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  1.6.4 [*] (WBS 1.6.4 - reserved)

 

  1.6.5 [*] (WBS 1.6.5).

 

       [*]

1.6.5.1  [*]

1.6.5.2  [*]

 

2. CLIN 2

 

2.1 Program Management (WBS 2.1)

 

  2.1.1 Program management scope is consistent with that outlined in CLIN 1.

 

2.2 [*] (WBS 2.2 – reserved)

 

2.3 [*] (WBS 2.3 – reserved)

 

2.4 [*] (WBS 2.4)

 

  2.4.1 [*] (WBS 2.4.1)

 

  2.4.1.1 [*]

 

  2.4.1.2 [*]

 

  2.4.2 [*] (WBS 2.4.2)

2.4.2.1  [*]

 

2.5 [*] (WBS 2.5)

 

  2.5.1 [*] (WBS 2.5.1 – reserved)

 

  2.5.2 [*] (WBS 2.5.2)

 

  2.5.2.1 [*]

 

  2.5.2.2 [*]

 

  2.5.2.4 [*]

 

2.6 [*] (WBS 2.6)

 

  2.6.1 [*] (WBS 2.6.1 - reserved)

 

  2.6.2 [*] (WBS 2.6.2 - reserved)

2.6.3 [*] (WBS 2.6.3)

 

  2.6.3.1 [*]

 

  2.6.3.2 [*]

 

  2.6.3.3 [*]

 

  2.6.3.4 [*]

 

  2.6.4 [*] (WBS 2.6.4 - reserved)

 

  2.6.5 [*] (WBS 2.6.5).

 

  2.6.5.1 [*] (WBS 2.6.5.1)

 

3. CLIN 3

 

3.1 Program Management (WBS 3.1)

 

  3.1.1 Program management scope is consistent with that outlined in CLIN 2.

 

3.2 [*] (WBS 3.2 - reserved)

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 

69

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3.3 [*] (WBS 3.3)

 

  3.3.1 [*] (WBS 3.3.1 – reserved)

 

  3.3.2 [*] (WBS 3.3.2 – reserved)

 

  3.3.3 [*] (WBS 3.3.3)

 

  3.3.3.1 [*]

 

  3.3.3.2 [*]

 

  3.3.3.3 [*]

 

3.4 [*] (WBS 3.4)

 

  3.4.1 [*] (WBS 3.4.1)

 

  3.4.1.1 [*]

 

  3.4.2 [*] (WBS 3.4.2 - reserved)

 

3.5 [*] (WBS 3.5)

 

  3.5.1 [*] (WBS 3.5.1 – reserved)

 

  3.5.2 [*] (WBS 3.5.2)

 

  3.5.2.1 [*]

 

  3.5.2.2 [*]

 

3.6 [*] (WBS 3.6)

 

  3.6.1 [*] (WBS 3.6.1 - reserved)

 

  3.6.2 [*] (WBS 3.6.2 - reserved)

 

  3.6.3 [*] (WBS 3.6.3)

 

  3.6.3.1 [*]

 

  3.6.4 [*] (WBS 3.6.4 - reserved)

 

  3.6.5 [*] (WBS 3.6.5)

 

  3.6.5.1 [*] (WBS 3.6.5.1)

 

4. CLIN 4 (GOVERNMENT/CONTRACTOR COST-SHARE)

 

4.1 Program Management (WBS 4.1)

 

  4.1.1 Program management scope is consistent with that in CLIN 3.

 

4.2 [*] (WBS 4.2 – reserved)

 

4.3 [*] (WBS 4.3 - reserved)

 

4.4 [*] (WBS 4.4)

 

  4.4.1 [*] (WBS 4.4.1 – reserved)

 

  4.4.2 [*] (WBS 4.4.2)

 

  4.4.2.1 [*]

 

4.5 [*] (WBS 4.5 - reserved)

 

4.6 [*] (WBS 4.6 - reserved)

 

5. CLIN 5

 

5.1 Program Management (WBS 5.1)

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 

70

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  5.1.1 Program management scope is consistent with that in CLIN 4.

 

5.2 [*] (WBS 5.2 - reserved)

 

5.3 [*] (WBS 5.3 - reserved)

 

5.4 [*] (WBS 5.4 - reserved)

 

5.5 [*] (WBS 5.5)

 

  5.5.1 [*] (WBS 5.5.1 – reserved)

 

  5.5.2 [*] (WBS 5.5.2)

 

  5.5.2.1 [*]

 

  5.5.2.2 [*]

 

5.6 [*] (WBS 5.6 - reserved)

 

6. OTHER ITEMS

 

6.1 Facilities, Equipment, and Other Resources

The Contractor confirms the subcontractor and all purchased commercial service
providers provide equipment, facilities and other resources under Federal and
HHS regulations.

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 

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Attachment 2

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, including those 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.

 

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(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) or the
portion of the fixed-fee applicable to a particular invoice as defined in the
contract.

 

(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.

 

73

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  (1) Direct Labor: Include salaries and wages paid (or accrued) for direct
performance of the contract. List individuals by name, title/position,
hourly/annual rate, level of effort (actual hours or % of effort), breakdown by
task performed by personnel, and amount claimed.

 

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

 

  (3) Accountable Personal Property: Include any property having a unit
acquisition cost of $5,000 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)(e.g. personal computers). Note this is not
permitted for reimbursement without pre-authorization from the CO.

On a separate sheet of paper attached to the payment request, list each item for
which reimbursement is requested. 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 all consumable material and supplies
regardless of amount. Detailed line-item breakdown (e.g. receipts, quotes, etc.)
is required.

 

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

 

  (8) Subcontract Costs: List subcontractor(s) by name and amount billed.
Provide subcontract invoices/receipts as backup documentation. If subcontract is
of the cost-reimbursement variety, detailed breakdown will be required.
Regardless, include backup documentation (e.g. subcontractor invoices, quotes,
etc.).

 

  (9) Other: Include all other direct costs not fitting into an aforementioned
category. 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, if applicable.

 

(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.

 

74

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(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.”

**Note the Contracting Officer may require the Contractor to submit detailed
support for costs claimed on payment requests. Every cost must be determined to
be allocable, reasonable, and allowable per FAR Part 31.

 

75

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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.

 

76

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SAMPLE INVOICE/PAYMENT REQUEST AND CONTRACT FINANCIAL REPORT

 

(a)

  Designated Billing Office Name and Address:    (c)   Invoice/Financing Request
No.:    

 

DHHS/OS/ASPR/BARDA

  

 

(d)

 

 

Date Invoice Prepared:

   

Attn: Contracting Officer

330 Independence Ave., S.W.

Room G644

Washington, D.C. 20201

  

 

(e)

 

(f)

 

 

 

Contract No. and Order No. (if applicable):             

 

Effective Date:

 

 

(b)

 

 

Contractor’s Name, Address, Point of Contact, VIN, and DUNS or DUNS+4 Number:

  

(g)

 

(h)

 

Total Estimated Cost of Conract/Order:

 

Total Fixed-Fee (if applicable):

   

 

ABC CORPORATION

  

 

(i)

 

 

¨ Two-Way Match:

    100 Main Street      ¨ Three-Way Match     Anywhere, USA Zip Code   

 

(j)

 

 

Office of Acquisitions:

   

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.

  

 

(k)

 

 

Central Point of Distribution

   

 

VIN:

          

DUNS or DUNS+4

 

        

 

(l) This invoice/financing request 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

 

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Attachment 3

 

 

FINANCIAL REPORT OF INDIVIDUAL

PROJECT/CONTRACT

 

Note: Complete this Form in Accordance with Accompanying Instructions.

 

   Project Task:    Contract No.:    Date of Report:   

 

0990-0134

0990-0131

  

Reporting Period:

 

  

Contractor Name and Address:

 

Expenditure Category*       

 

Percentage of

Effort/Hours

 

   Cumulative 
Incurred  Cost 
at End of 
Prior Period    

Incurred  

Cost-  

-Current  

  

Cumulative  

Cost to Date  

(D + E)  

   Estimated  
Cost to  
Complete      Estimated Cost at  
Completion (F+G)      Negotiated  
Contract  
Amount      Variance (Over
or Under) (I-H)   

 

Negotiated    

   Actual                      

 

A

   B    C    D    E    F    G    H    I    J                                    
                                                                                
                                                                                
                                                                                
                                                                                
                                                                                
                                                                                
                                                                                
                                                                                
                                                                                
                                                                                
                                                                 

 

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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) Key Personnel. Include key personnel regardless of annual salary rates. All
such individuals should be listed by names and job titles on a separate line
including those whose salary is not directly charged to the contract but whose
effort is directly associated with the contract. The listing must be kept up to
date.

 

(2) Personnel--Other. List as one amount unless otherwise required by the
contract.

 

(3) Fringe Benefits. Include allowances and services provided by the contractor
to employees as compensation in addition to regular salaries and wages. If a
fringe benefit rate(s) has been established, identify the base, rate, and amount
billed for each category. If a rate has not been established, the various fringe
benefit costs may be required to be shown separately. Fringe benefits which are
included in the indirect cost rate should not be shown here.

 

(4) Accountable Personal Property. Include nonexpendable personal property with
an acquisition cost of $1,000 or more and with an expected useful life of two or
more years, and sensitive items regardless of cost. Form 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.”

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

(16) Total Costs to the Government.

PREPARATON 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.

 

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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.

 

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Attachment 5

INCLUSION ENROLLMENT REPORT

This report format should NOT be used for data collection from study
participants

Study Title:

 

                   

Total Enrollment:

 

      Protocol Number:

Contract Number:

 

                   

 

PART A. TOTAL ENROLLMENT REPORT:            Number of Subjects Enrolled to Date
(Cumulative) by Ethnicity and Race

 

Ethnic Category   Sex/Gender             Females     Males    
  Unknown or Not Reported       Total

Hispanic or Latino

 

                   

Not Hispanic or Latino

 

                   

Unknown (Individuals not reporting ethnicity)

 

                   

Ethnic Category: Total of All Subjects*

 

                   

 

Racial Categories

 

                   

American Indian/Alaska Native

 

                   

Asian

 

                   

Native Hawaiian or Other Pacific Islander

 

                   

Black or African American

 

                   

White

 

                   

More than one race

 

                   

Unknown or not reported

 

                   

Racial Categories: Total of All Subjects*

 

                   

 

    

 

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

 

 

Racial Categories

 

 

 

Females  

 

 

Males  

 

 

  Unknown or Not Reported   

 

 

Total

American Indian/Alaska Native

 

                   

Asian

 

                   

Native Hawaiian or Other Pacific Islander

 

                   

Black or African American

 

                   

White

 

                   

More than one race

 

                   

Unknown or not reported

 

                   

Racial Categories: Total of Hispanics or Latinos**

 

                   

*These totals must agree

** these totals must agree

                   

 

82

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Attachment 6

Research Patient Care Costs

(a)        Research patient care costs are the costs of routine and ancillary
services provided to patients participating in research programs described in
this contract.

(b)        Research patient care costs shall be computed in a manner consistent
with the principles and procedures used by the Medicare Program for determining
the part of Medicare reimbursement based on reasonable costs. The Diagnostic
Related Group (DRG) prospective reimbursement method used to determine the
remaining portion of Medicare reimbursement shall not be used to determine
research patient care costs. Research patient care rates or amounts shall be
established by the Secretary of HHS or his/her duly authorized representative.

(c)        Prior to submitting an invoice for research patient care costs under
this contract, the contractor must make every reasonable effort to obtain third
party payment, where third party payors (including Government agencies) are
authorized or are under a legal obligation to pay all or a portion of the
charges incurred under this contract for research patient care.

(d)        The contractor must maintain adequate procedures to identify those
research patients participating in this contract who are eligible for third
party reimbursement.

(e)        Only those charges not recoverable from third party payors or
patients and which are consistent with the terms and conditions of the contract
are chargeable to this contract.

 

83

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Attachment 7

 

Contracting Site – Contract number –

Inventory Sheet

 

DHHS TAG*

   S/N    TYPE    MAKE    MODEL    LOCATION                                    
                                                                                
                                                                                
                                                                                
                                                                                
                                                                                
                                                                                
                                                                                
                                                                                
                                                                                
                          

 

*Until or unless BARDA affixes an HHS generated ID, the contractor shall track
and monitor all equipment, materials, and supplies purchased under this contract
in a manner which affords a clear distinction from other contractor property.

 

84

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Department of Health & Human Services

HHS

Office of the Assistant Secretary for Preparedness and Readiness

ASPR

Biomedical Advanced Research and Development Authority

BARDA

7 Principles of Earned Value

Management

Tier 2

System Implementation

Intent Guide

21 December 2011

 

LOGO [g539986ex10_15pg085.jpg]

 

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

TABLE OF CONTENTS

 

 

OVERVIEW      1    EVM IMPLEMENTATION TIERS      2    SEVEN PRINCIPLES OF EVM   
  3   

Principle 1: Plan all Work Scope

     3   

Principle 2: Break Work into Finite Pieces and Define Person/Organization
Responsible for Work

     3   

Principle 3a: Integrate Scope, Schedule and Budget into a Performance
Measurement Baseline

     4   

Principle 3b: Control Changes to the Baseline

     5   

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

     5   

Principle 5: Objectively Assess Accomplishments at the Work Performance Level

     6   

Principle 6a: Analyze Significant Variances From the Plan

     7   

Principle 6b: Prepare an Estimate at Completion Based on Performance to Date and
Work to be Performed

     7   

Principle 7: Use EVMS Information in the Company’s Management Processes

     7    APPENDICES      9   

APPENDIX 1: Glossary of Terms

     9   

Appendix 2 Supplemental EVM Implementation Guideline

     15   

Appendix 3 Sample EVM Documents

     17   

 

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7 Principles of EVM Tier 2 System Implementation Intent Guide

 

OVERVIEW

Earned Value Management (EVM) is a program management tool, technique, and
discipline that facilitates systematic planning for and monitoring of, high
value, complex projects. It integrates a project’s scope of work with the
related budget and schedule to permit detailed assessment of overall performance
during the life of the project.

Several government-wide guidance documents govern the definition and use of EVM
systems. Guidelines outlining the qualities and characteristics of an EVM system
are set forth in the American National Standards Institute/Electronic Industries
Alliance (ANSI/EIA) Standard-748 (most current version). More detailed and
specific guidance and direction is contained in OMB Circular A-11, Preparation,
Submission and Execution of the Budget, specifically in Part 7 of that Circular
A-11, Planning, Budgeting, Acquisition, and Management of Capital Assets, and
its supplement, the Capital Programming Guide. Based on this collective OMB
guidance, EVMS is intended to be used on those parts of acquisitions that will
involve developmental effort. This would include not only those acquisitions
designated by the agency as major systems but also those acquisitions that
include significant developmental, modification, or upgrade during the
operational or steady-state phase of a program.

The FAR rule on EVMS became effective on July 5, 2006. Its purpose is to
implement EVMS policy in accordance with OMB Circular A-11. Because the new FAR
coverage applies throughout the executive branch and to agencies with disparate
definitions of and processes and procedures for major systems acquisitions, the
FAR Council decided against a “one-size-fits all” approach and left several
significant aspects of the detailed implementation up to the discretion of each
covered agency.

The FAR and Health and Human Services Acquisition Regulations (HHSAR) language
for EVMS will be utilized for all construction or Information Technology (IT)
projects. Since most of the acquisitions at the Biomedical Advanced Research and
Development Agency (BARDA) are unique in that most acquisitions are not
Information Technology projects or construction projects, BARDA is developing
EVM language that incorporates the 7 Principles of Earned Value Management.
These principles allow flexibility to an EVM system structure but still meet the
spirit of the ANSI/EIA Standard-748. It also incorporates discipline in
implementation and operations and also provides the same reporting data outlined
by OMB.

The Seven Principles of Earned Value Management are as follows:

 

  1. Plan all work scope to completion

 

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

 

  3. Integrate program work scope, schedule, and cost objectives into a
performance measurement baseline plan against which accomplishments can be
measured. Control changes to the baseline.

 

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

 

  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 earned value information in the company’s management processes.

 

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7 Principles of EVM Tier 2 System Implementation Intent Guide

 

EVM IMPLEMENTATION TIERS

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

TIER 1

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

TIER 2

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

TIER 3

For countermeasure research and development contracts that have total
acquisition costs less than $25 million but greater than $10 million will apply
EVM principles for tracking cost, schedule and technical performance that are
consistent with the 7 Principles of EVM Implementation.

This Guide is an explanation of the intent of what is expected for a Tier 2
system implementation of the 7 Principles of EVM.

 

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7 Principles of EVM Tier 2 System Implementation Intent Guide

 

SEVEN PRINCIPLES OF EVM

Principle 1: Plan all Work Scope

In a performance measurement system implementation the Statement of Work (SOW)
should reflect all work that is to be performed. In a 7 Principles
implementation a Work Breakdown Structure (WBS) shall be developed to include
all elements of the SOW. The level of the WBS may not be as detailed as in a
Tier 1 implementation. It would be developed at a higher level, such as level
three or four, however, the government may expand specific technical legs to
lower than level four and it may retract some non-technical legs to higher than
3. It is beneficial and required to develop a WBS dictionary that explains what
work is going to be performed in each WBS in detail. This will ensure that the
contractor has identified all work scope and left no major work undefined. It is
recommended that the work packages descriptions are clear and detailed so that
there is an understanding of the work that is to be performed in the work
packages. For the 7 Principles implementation programs it would be acceptable
for the WBS Dictionary be expanded to include information that would normally be
kept on a Work Authorization Document, such as charge numbers associated with
the work, period of performance, the manager who is responsible for the work,
and budget associated with the WBS. The additional “WAD info” would only be
added to the lowest level (i.e. level 3 or 4) of the WBS. The roll up level WBS
would only include scope. By doing this documentation is limited to one document
instead of two.

By developing a WBS and a WBS Dictionary/Work Authorization Document the work
scope has been defined but the documentation is greatly reduced and the costs
associated with developing and updating the documentation is reduced. The intent
of the combination document is not to reduce the level of information provided
to the government but to reduce the amount of documents that need to be
produced. An example of a WBS dictionary and Work Authorization document and
what is expected on the document(s) is provided.

Principle 2: Break Work into Finite Pieces and Define Person/Organization
Responsible for Work

In a 7 Principles Tier 2 implementation it is recommended that the work be
broken into finite pieces in the schedule tool. It is recommended to plan the
work by the lowest level WBS. The lowest level WBS (level 3 or 4) should be the
control account and the activities would act as the work packages. For Tier 2
programs that are of larger value (greater than $25M) the expectation is that
the control account will be at least at level 4 and potentially level 5. Most of
the normal functions accomplished when scheduling will be required on a 7
Principles Tier 2 implementation. These normal functions include, network
scheduling, horizontal and vertical traceability, forecasting schedule start and
completion dates, and running critical path analysis. As part of vertical
traceability it is expected that all contract milestones will be listed on the
schedule.

The schedule should include but is not limited to include the following fields:

WBS number

Control Account number

Work package number

Task name

Duration

Baseline Start and Finish Dates

Actual Start and Finish Dates

Forecast Start and Finish Dates

Predecessor/Successors

Activity Percent Complete

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

 

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7 Principles of EVM Tier 2 System Implementation Intent Guide

 

Principle 3a: Integrate Scope, Schedule and Budget into a Performance
Measurement Baseline

This principle integrates the work scope, the schedule and the budget into a
performance measurement baseline. Since we discussed work scope and schedule the
focus of this principle is the incorporation of the budget in a time-phased
manner. The budget must be integrated with the scope of work and the schedule
into a Performance Measurement Baseline (PMB). The budget is made up of both
direct and indirect dollars. An accepted way of incorporating the budget and
integrating with the scope and schedule is to resource load the Microsoft
Project (or other scheduling tool) schedule. This is done by loading the
individual people and their loaded rate into the tool. This budget data will be
input at the work package level with a rate that includes the indirect costs.
The budget will have to have the capability to be rolled up to the control
account level and will need to be reported in a way that provides the
responsible manager (Control Account Manager) with information needed to manage
the program. Resource loading of the schedule is not the only way to incorporate
the budget. As long as the budget in the budget/EV tool is linked to the
schedule activities and it is flexible to change when schedule baseline dates
change, then loading the budget in the Budget/EV tool is an acceptable way to
integrate the cost and schedule baselines. The budget information will be
displayed on the time-phased Control Account Plan reports. These reports should
have the flexibility to report the dollars both in total dollars, as well as,
direct and indirect broken out separately. Also the report is generally required
as a deliverable on most contracts and must have the capability to include
earned value or Budgeted Cost of Work Performed (BCWP) and actual costs or
Actual Costs of Work Performed (ACWP).

Budgeting of subcontractor effort will vary depending on whether or not the
subcontractor is a cost plus or fixed price subcontract. If it is cost plus then
the expectation is that there will be monthly billing of costs from the
subcontractor to the prime contractor and therefore budget must be planned in
accordance with the work completed and billed. If it is fixed price then the
budget should be planned with work execution or milestones completed and budget
should only be planned in those months where work is expected to be completed.

It is recommended that management reserve and undistributed budget be utilized
in the budgeting process. Undistributed budget is budget that has not yet been
distributed to a control account and it requires additional time to plan the
work and distribute the budget to a control account. It is a temporary holding
account and budget should only stay in Undistributed Budget for one or two
months. If the work scope is easily identified to all the control accounts then
the use of Undistributed Budget may not be necessary.

Management Reserve is budget that is set aside, normally by the Program Manager,
to be used to budget future but currently unknown tasks. It is associated with
risk issues and is to be used to mitigate risk. It is not part of the
Performance Measurement Baseline and it should not be used for out of scope work
and to cover overruns.

 

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7 Principles of EVM Tier 2 System Implementation Intent Guide

 

Principle 3b: Control Changes to the Baseline

A properly controlled PMB is crucial to effective program management. The timely
and accurate incorporation of contractual changes ensures that the information
generated from the execution of the baseline plan provides an accurate picture
of progress and facilitates correct management actions and decisions. The
accurate and timely incorporation of authorized and negotiated changes into the
PMB ensures that valid performance measurement information is generated for the
new scope being executed. Near term new scope effort should be planned and have
budget in control accounts. Far term new scope effort that cannot be reasonably
planned in the near term can either be put in planning packages in the control
account or left in Undistributed Budget if the control account has not been
identified. The timely and accurate incorporation of authorized and negotiated
changes into the PMB ensures that valid performance measurement information is
generated for the new scope being executed. Budget revisions are made when work
is added to the contract and are traceable from authorized contract target costs
to the control account budgets or from management reserve. Management reserve
may be used for future work when additional in-scope work has been identified.

Retroactive changes to the baseline may mask variance trends and prevent the use
of performance data to project estimates of cost and schedule at completion.
Controlling retroactive adjustments, which should only be made in the current
period, if possible, is imperative because they could arbitrarily eliminate
existing cost and schedule variances.

The use of program budget logs should be used to track and log all budget
changes. The ability to track budget values for both the internal and external
changes will help in the maintenance of the performance measurement baseline
from program start to completion. Contractor is expected to utilize baseline
change documentation facilitating the change. It should provide the
rationale/justification, approval process, work scope additions or deletions,
dollars, changes to schedules, estimate at completion, etc. It should also
include contractual change documents for external changes, such as a contract
modification, letter to proceed, not to exceed letter, change order, etc., that
transmit and authorize the change or addition to work, budget, and schedule.
Other documents that should change if a change of scope has been authorized is:
Statement of Work, WBS (changes if applicable); WBS Dictionary (additions or
deletions to scope); work authorization documents authorizing new scope,
schedule and budget; schedules.

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

Some of the new acquisitions at BARDA will be required to be compliant with the
Cost Accounting Standards. For 7 Principles implementation contractors must
utilize a work order/job order/task code charge number structure that uniquely
identifies costs at the control account level. This will allow for accumulation
and summarization of costs to higher levels of the work breakdown structure.
Actual costs are accumulated in the formal accounting system in a manner
consistent with the way the related work is planned and budgeted. Actual costs
reported in the performance reports agrees with the costs recorded in the
accounting system or can be explained as timing differences. The contractor will
have to be able to incorporate and reconcile to the accounting system actual
costs on their Contract Performance Reports (CPR) to the customer.

Depending on the amount of material and subcontractors on the program, it may be
necessary for reporting purposes, to include accruals, or estimated actuals, for
these costs. Since material and subcontractor invoices are not paid and recorded
in the accounting system for up to several months after the work has been
planned, performance data will be skewed. Accruing or estimating actual costs
based on receipt (for material) and expended hours for subcontractors will
alleviate this issue. The use of accrual/estimated actuals should be reviewed on
a case by case basis depending on the size of program, the amount of material or
subcontractor budget and costs. If the material and subcontract effort on the
project is minimal (represents less than 5% of the project budget) then the time
and effort needed to manage the accruals would outweigh the benefit of having
the costs accrued since the performance data would only be minimally affected.
Although actual costs are generally reported to the USG in total dollars the
system must be able to differentiate and report direct costs and indirect costs
if requested.

If the subcontractor has a fixed price contract the prime contractor, then the
prime contractor must report actual costs in accordance with the work that is
accomplished. This is acheived by recording the actual costs equal to the work

 

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7 Principles of EVM Tier 2 System Implementation Intent Guide

 

that was performed in the EVM system and on the CPR. If the subcontractor is a
cost plus contract its imperative the costs the prime reports is in accordance
with the costs incurred in that month. This is necessary to ensure that the data
reported is not skewed. With this premise, fixed price subcontractors cost
variances should not exist or be reported on the CPR whereas the cost reported
for cost plus subcontractors should be based on what was incurred and not what
has been invoiced to date, which may be months behind.

Principle 5: Objectively Assess Accomplishments at the Work Performance Level

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

Schedule status to measure progress needs to be on at least on a monthly basis
although it is preferred on a bi-weekly basis. As part of the status process
progress dates, such as actual start/complete and forecast start/complete need
to be updated.

Since Microsoft Project seems to be the schedule tool of choice by most
contractors, there are four types of earned value methodologies utilized by
Microsoft Project of which two assess progress by the completion of milestones
and they are the 50/50 and 0/100 methodologies. In both cases, progress is
reported for completion milestones and in the 50/50 methodology fifty percent of
the value of the work package/activity is credited for starting the work. The
other two earned value methodologies are assessed percent complete (also know as
Supervisor’s Estimate) and level of effort (LOE). All four methodologies are
legitimate earn value measurement techniques but the assessed percent complete
based or supervisor’s estimates are highly discouraged. The reason is that it is
highly subjective and is not based on any quantifiable criteria. BARDA will not
accept these earned value methodologies unless approved as an exception on a
case by case basis. If percent complete on work packages is used with objective
measurable activities, the contractor must show distinct relationship between
the budget planned at the work package level and the value earned at the
activity level. If this is done properly then the measurement will be objective
and the schedule variance will be clearly understood and easy to explain. If
this is not done properly then schedule activities are not aligned with the
budget in the performance measurement baseline and schedule variances will not
be easy to understand. If the latter is the case, BARDA will not accept that as
an acceptable earned value methodology.

There are built in weaknesses with the 0/100 and 50/50 methodologies also. If
the responsible manager is being asked to plan their work in monthly increments
in order to utilize the 0/100 methodology then they may be asked to break the
work up in pieces that don’t make logical sense or represent the natural ending
of the work. Also the 50/50 methodology, which is usually used for a two month
work package, will provide skewed monthly data if the resources in the work
package are not loaded equally for each month. It will give an artificial
positive or negative schedule variance the first month and vice versa the next
month.

Additional earned value methodologies, such as the weighted milestone
methodology and percent complete with milestone gates may be utilized. The
weighted milestone method allows value to be earned based on the resource value
in each month, which eliminates artificial schedule variances.

For all discrete measurable work packages or control accounts, there must be an
activity in each month to measure. Gaps, in which there is nothing to measure in
a month or months is not acceptable.

For subcontractors that have a fixed price contract with the prime contractor,
the expectation is that there will be no cost variance. The ACWP reported on the
CPR will equal the BCWP earned, regardless of the payment schedule with
subcontractor.

 

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Principle 6a: Analyze Significant Variances From the Plan

The purpose of this principle is to ensure that the earned value data is
analyzed by the contractor and reported to the customer. The 7 Principles
programs should be able to calculate the cost variance (BCWP minus Actual Cost
of Work Performed (ACWP) and the schedule variance (BCWP minus BCWS) at least on
a cumulative basis. It is recommended that variances be calculated on a current
month basis also. The EVM system should also provide both monthly and cumulative
Cost Performance Index (BCWP divided by ACWP) and Schedule Performance Index
(BCWP divided by the BCWS). This data should be provided at the control account
level and at the roll up levels and it needs to be in a format for Control
Account Managers and program management to be able to utilize in managing the
work.

It is also recommended that the To-Complete Performance Index (TCPI) be included
in the Control Account Manager performance report. The TCPI is a valuable index
that calculates the cost performance the control account needs to perform at in
order to complete the work within the current reported EAC. When the TCPI is
compared against the cumulative CPI it gives a good indication whether or not
the current EAC is reasonable. For example, if a cumulative CPI is .85 and the
TCPI calculates to equal 1.15 that is the performance factor that work would
need to perform at in order to meet the current EAC. If the cumulative CPI is
.85 then it can be determined that the current EAC might not be reasonable. It
allows management and Project Controls the opportunity to question the Control
Account Manager as to the validity of the current EAC. As a rule in thumb if the
deviation between the CPI and the TCPI is greater than .2 then the CAM should
reassess the control account EAC.

These reports, which should be provided monthly, should also include the current
Budget at Completion (BAC) and the current Estimate at Completion (EAC). In
addition, it would be a plus if the CAM could see a report with their
time-phased spread of hours and dollars for their budget plan (BCWS), work
accomplished (BCWP) and actual costs (ACWP).

For all variances that exceed the contractual variance threshold will include a
description of what caused the variance, impact to the control account and the
program, and a corrective action.

Principle 6b: Prepare an Estimate at Completion Based on Performance to Date and
Work to be Performed

Providing an updated EAC is a prime concern of the customer and the contractor.
Therefore a robust EAC process should be in place whether the program is ANSI
compliant or not.

Based on the performance to date the Estimates at Completion can be updated on a
monthly basis by the Control Account Manager in the scheduling tool during the
status process or in the cost/EVM tool at the end of the month’s process prior
to submittal of the EVM report. The EAC is an element of the performance
measurement system that needs to accurately reflect the contractor’s best
estimate of what it will cost to complete the project.

Program management should be able to validate control account manager’s EACs by
looking at performance indices, such as the To-Complete Performance Index, as
well as independent statistical EACs.

Principle 7: Use EVMS Information in the Company’s Management Processes

One of the key areas that concerns government Program Management Offices (PMO)
is the level of importance that contractor’s place on EVM as a management tool.
During a site visit, such as conducting an Integrated Baseline Review, the PMO
gauges what the interest, knowledge, and most importantly, the usage of the
performance measurement data in managing the program. They want to know that the
managers on the program, including the program manager, have received some
earned value training. The level of involvement and use of the EVM data to
manage their schedule, cost and technical issues is ascertained by questions.
The PMO can also tell by how robust the EACs are and if the variance narratives
are being written with impacts to the program and corrective actions being
monitored by the contractor. It is important that the contractor’s management
team, including the Program Manager, utilize the data from the performance
measurement system as a management tool. They should be knowledgeable and
understand the data. They should know what is causing the variances and ensure
that the

 

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7 Principles of EVM Tier 2 System Implementation Intent Guide

 

variance narratives are written properly and answer what the issues, impacts and
corrective actions are. They should be able to demonstrate that they use the
information to assist them in the management decision process. They should hold
their Control Account Managers accountable to use the data and write clear
proper variance analysis report (VAR). If the Control Account Manager does not
write a proper VAR then Project Controls needs to help instruct them how to do
it. It is recommended that prior to the Earned Value report be sent to the
government that the Program Manager has a meeting with the Control Account
Managers and Project Control and review the data and ensure that the variance
analysis is complete and that the Program Manager agrees with it. This review is
also used to ensure that the EACs are acceptable to the Program Manager, who is
ultimately responsible for the program EAC. This is an efficient and quick way
to make any adjustments to the earned value report since all the key personnel
are in one room. If the data appears to be unreliable then the PM needs to hold
Project Controls accountable to ensure that they are using discipline in
changing baselines, assessing process properly, and capturing actual costs to
ensure that the data that is reported is accurate.

 

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7 Principles of EVM Tier 2 System Implementation Intent Guide

 

APPENDICES

The following appendices provide further support in understanding the meaning
and intent of properly implementing the 7 Principles of EVM.

Appendix 1 is a glossary of the terms used in the Intent Guide.

Appendix 2 is supplemental guidance on EVM implementation. It provides some
guidelines on what is expected in the implementation, required documents needed
for the Performance Measurement Baseline Review, expected EVM implementation
costs, EVM engines functionality needs, explains what is expected in the monthly
EVM facilitation, discusses what EVM consultants need to know, and what the
expected costs of EVM to BARDA.

Appendix 3 are examples of some of the EVM documents that are needed in an EVM
system. There are three documents and they mostly apply to Tier 2 EVM
implementations. These documents are samples and are not a reflection of the
specific way the document must look. It’s included to provide contractors with
an understanding of the type of information that is expected on these forms.

APPENDIX 1: Glossary of Terms

Actual Cost of Work Performed (ACWP)    The costs actually applied and recorded
in accomplishing the work performed within a specified period. Actual Direct
Cost    Those costs identified specifically with a contract, based upon the
contractor’s cost identification and accumulation system as accepted by the
cognizant DCAA representatives. (See Direct Costs). Advance Agreement (AA)    An
agreement between the contractor and the Contract Administration Office
concerning the application of an approved earned value management system to
contracts within the affected facility. Authorized Work    That effort which has
been authorized and is on contract, or that for which authorized contract costs
have not been agreed to but for which written authorization has been received.
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).

Budgeted Cost for Work

Scheduled (BCWP)

   The sum of the budgets for completed Work Packages, planning packages, etc.,
scheduled to be accomplished (including in-process Work Packages), plus the
amount of level of effort and apportioned effort scheduled to be accomplished
within a given time period. Change Order (CO)    A formal authorization by the
Procuring Contracting Officer for a change of scope to an existing contract
Contract Modification    A written and binding authorization to proceed created
after change proposal negotiations.

 

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Contract Budget Base (CBB)    The negotiated contract cost plus the estimated
cost of authorized unpriced work, where:    (1) Negotiated Contract Cost is that
cost on which contractual agreement has been reached. For an incentive contract,
it is the definitized contract target cost plus/minus the value of changes which
have been priced and incorporated into the contract through contract change
order or supplemental agreement. For fixed-fee contracts, it is the negotiated
estimated cost. Changes to the estimated cost will consist only of the formal
contract modifications or change orders or change in the contract statement of
work, not for cost growth, and    (2) Estimated cost of authorized, unpriced
work is the estimated cost (excluding fee or profit) for that work for which
written authorization has been received, but for which definitized contract
prices have not been incorporated into the contract through supplemental
agreement. Control Account    A management control point at which actual costs
can 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).

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. Cost Performance
Index (CPI)    An efficiency rating reflecting a project’s budget performance -
either over or under. Measured as a ratio of the budgeted value of work
accomplished versus the actual costs expended for a given project time period.
The formula for CPI is BCWP/ACWP. Discrete Effort    Program effort that has a
measurable output, product or service. Direct Costs    Those costs (labor,
material, etc.) that can be reasonably and consistently related directly to
service performed on a unit of work, and are charged directly to the contract,
without distribution to an overhead unit. Earned Value    See Budgeted Cost for
Work Performed (BCWP)

Earned Value Management

System (EVMS)

   A project management system utilized for measuring 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. Indirect Costs
   Represents those costs, because they are incurred for common or joint
objectives, are not readily subject to treatment as direct costs. (See
overhead). Integrated Baseline Review (IBR)   

An Integrated Baseline Review (IBR) also known as Performance Measurement
Baseline Review (PMBR) is a formal review led by the Government Program Manager
and Technical Support Staff. An IBR is conducted jointly with the Government and
their Contractor counterparts.

 

The purpose of an IBR is to: verify the technical content of the Performance
Measurement Baseline (PMB); assess the accuracy of the related resources
(budgets) and schedules; identify potential risks.

Integrated Master Plan (IMP)    The overall program plan including the work
definition, technical approach, performance criteria, and completion criteria.
Integrated Master Schedule (IMS)    The IMS expands the IMP to the work planning
level. It defines the tasks, their durations, milestones, milestone dates which
relate to the IMP completion criteria, and interdependencies required to
complete the program. The IMP and IMS are used to track and execute the program.
Integrated Product Team (IPT)    A grouping of project personnel along project
objective lines rather than along organizational lines. Integrated Product Teams
are work teams that represent a transition from a functional organization
structure to a multi-functional project objective arrangement. Internal
Replanning    Replanning actions performed by the program for remaining effort
within the recognized total allocated budget. Level of Effort (LOE)    Work that
does not result in a final product, e. g., liaison, coordination, follow-up, or
other support activities, and which cannot be effectively associated with a
definable end product process result. It is measured only in terms of resources
actually consumed within a given time period. Management Reserve (MR)    An
amount of the total Contract Budget Base (CBB) withheld for management control
purposes rather than designated for the accomplishment of a specific task or set
of tasks. It is not a part of the Performance Measurement Baseline. Negotiated
Contract Target Cost    The estimated cost negotiated in a Cost Plus Award Fee
(CPAF), Cost Plus Fixed Fee (CPFF), Cost Plus Incentive Fee (CPIF) or Fixed
Price Incentive Fee (FPIF) contract. Original Budget    The budget established
at, or near, the time the contract was signed, based on the negotiated contract
cost.

 

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Overhead    Indirect labor and material, supplies and services costs and other
charges, which cannot be consistently identified with individual programs. Other
Direct Costs    A group of accounting elements which can be isolated to specific
tasks, other than labor and material. Included in ODC are such items as travel,
computer time, and services

Performance Measurement

Baseline (PMB)

   The time-phased budget plan against which contract performance is measured.
It is formed by the budgets assigned to scheduled Control Accounts and the
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. Performing Organization    A
defined unit within the program organization structure, which applies the
resources to performs the authorized scope of work. Planning Package    A
logical aggregation of far term work within a Control Account that can be
identified and budgeted but not yet defined into Work Packages. Reprogramming   
Replanning of the effort remaining in the contract, resulting in a new budget
allocation which exceeds the contract budget base. The resulting baseline is
called an Over Target Baseline (OTB). Responsible Organization    A defined unit
within program’s organization structure that is assigned responsibility for
accomplishing specific tasks. 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.

Schedule Performance Index

(SPI)

   An efficiency rating reflecting how quickly or slowly project work is
progressing. Measured as a ratio of work accomplished versus work planned for a
given period of time. The formula for SPI is BCWP/BCWS. Significant Variances   
Those differences between planned and actual cost and schedule performance which
require further review, analysis, or action. Appropriate thresholds are
established as to the magnitude of variances which will require variance
analysis. Statistical Estimate at Completion    Is a single point estimate that
can be quickly prepared and used to test the reasonableness of the current cost
estimates and budget and to indicate when a comprehensive EAC should be prepared
Time-Phased S/P/A Report    Provides the timphased budget, performance (earned
value) and actual costs at a specific level. It may be at the reporting level,
control account, and/or work package level. In all cases the report will also
provide the data at the total project level.

To-Complete Performance Index

(TCPI)

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

 

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Total Allocated Budget (TAB)    The sum of all budgets allocated to the
contract. Total allocated budget consists of the performance measurement
baseline and all management reserve. The total allocated budget will reconcile
directly to the Contract Budget Base (CBB). Any differences will be documented
as to quantity and cause. Undistributed Budget (UB)    Budget applicable to
contract effort which has not yet been identified to WBS elements at or below
the lowest level of reporting to the Government. 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. Variances   
(See Significant Variances).

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.

Work Breakdown Structure

(WBS)

  

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

 

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

 

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

Work Packages   

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

 

It represents units of work at levels where work is performed.

 

It is clearly distinguishable from all other work packages.

 

It is assignable to a single organizational element.

 

It has scheduled start and finish dates and, as applicable, interim milestones,
all of which are representative of physical accomplishment.

 

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It has a budget or assigned value expressed in terms of dollars, man-hours or
other measurable units.

 

Its duration is limited to a relatively short span of time or it is subdivided
by discrete value milestones to facilitate the objective measurement of work
performed.

 

It is integrated with detailed engineering, manufacturing, or other schedules.

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

 

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Appendix 2 Supplemental EVM Implementation Guideline

Implementation of a 7 Principles of EVM system should be less expensive than if
there was an ANSI/EIA-748. There is no need for the system to have to go through
an EVM compliance review, plus the level of documentation should be streamlined.

The implementation should include:

 

  —  

EVM Process flows that reflect how a company will build and maintain the EVM
system. (EVM Procedures may also be included if the cost associated with them is
reasonable)

  —  

EVM engine tool and a schedule tool. It is not necessary to load the schedule
tool, such as Microsoft Project, with resources. This adds an extra strep,
additional costs and little to no value. It is recommended that all resource
information be loaded in the EVM engine and leave the schedule tool to what it
does best, measure progress through time (duration).

  —  

The EVM Engine needs to be integrated with the company’s accounting system.

Documentation needed for the Performance Measurement Baseline Review (PMBR)

 

  —  

WBS Dictionary/Control Account Work Authorization Documentation

  —  

Integrated Master Schedule

  —  

Responsibility Assignment Matrix

  —  

Control Account Plans

  —  

PMB Log

  —  

Baseline Revision Documents

  —  

Risk Register

EVM IMPLEMENTATION COSTS

The cost for an implementation depends on the size of the contract and the tier
level of EVM.

Tier 2 (projects greater than $25M) Implementation costs should range $75K-$150K

Tier 3 (projects less than $25M)

Implementation costs should range ($50K - $100K)

EVM ENGINES/TOOLS

Depending on the size of the contract would predicate the level of functionality
that would be needed. For Tier 2 contracts a larger, more robust EVM engine
would be needed. For the Tier 3 small contracts MS Project or the MSP
wrap-around would probably suffice although the more robust EVM engines can be
used also.

Tier 2

It is recommended that one of the larger and flexible EVM engines be utilized.
The tool should have the flexibility to be able to download data from MS Project
and be able to upload or input budget data to provide time-phased budget
information down to the work package level. It should be able to incorporate the
companies Organization Breakdown Structure. It should be able to maintain
baseline, actual costs, forecast and performance periodic data. It should be
able to forecast Estimate to Complete with the ability to set up different rate
tables if necessary. It should have the capability to use all earned value
methodologies. It should be able to print many types of EVM reports that can
provide information to the Control Account Managers (CAM) and Program Managers
(PM), as well as, the Contract Performance Report (CPR) and the Control Account
Plans (CAP) that are contract deliverables.

 

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Tier 3

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

EVM FACILITATION

EVM facilitation pertains to the monthly process to include:

 

  —  

Schedule Status

  —  

Integration of accounting data into EVM engine

  —  

Run monthly reports for Control Account Managers (Tier 2 only)

  —  

Prepare the monthly Contract Performance Report (CPR) Formats 1 and 5

  —  

Run the Control Account Plans for both internal and external (contract
requirement)

  —  

PMB Change Control

Depending on the size of contract, a contractor should have an EVM/cost analyst
and schedule analyst for a Tier 2 contract and one combined cost/schedule
analyst for a Tier 3 contract. The costs for a schedule analyst on a yearly
basis for an employee hire should be equal to or less than $135K. For a cost
analyst it should be equal to or less than $120K. If a company is bringing in a
contractor to provide staff implementation the costs should be up to $135/hr for
a schedule analyst and $120/hr for an EVM/cost analyst.

EVM CONSULTANTS

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

COST OF EVM

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

 

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Appendix 3 Sample EVM Documents

WBS 1.4.1.x Cardiac (QTc) Safety

Description

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

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

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

 

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Subcontractors

 

Vendor   

Area of Responsibility

Phase Research   

¡       

   Study Documentation Design and Development     

¡       

   Clinical Monitoring: Includes site initiation, interim, and close-out
monitoring visits,     

¡       

   Pharmacovigilence     

¡       

   Data Management: Includes build and maintenance of electronic case report
forms (eCRFs); data query generation and resolution     

¡       

   Biostatistics     

¡       

   Medical Writing:     

¡       

  

Project Management: The Project Manager will actively facilitate Phase
Research’s interaction with the research site and provide close monitoring
oversight in conjunction with the assigned CRA. Project Management will also
assist in the finalization of all applicable study documents and provide
coordination between study vendors.

    

¡       

   Pass-through Expenses        

 

Travel for CRA monitoring visits to clinical sites, shipping and printing costs

 

    

¡       

 

  

Investigator Grants

 

Energetics   

Core Cardiac Lab

 

TBD   

Clinical study site(s)

 

Pulse Tech   

To provide Central Lab services

 

Analyx   

To perform PK analyses

 

Claritron   

To write the PK report

 

Obelisk   

To label and distribute study drug product

 

Consultants

 

Joe Josephs  

Internal Medical Monitor:

 

Sponsor medical oversight

Rolf Xerd  

Pharmacologist:

 

Design and analysis consultation for PK parameters and analysis

Julie Simms  

Clinical Trials Manager

 

Phil Thomas  

Medical Writer

 

Claire Cools  

SAS Programmer

 

Mary Doe  

Clinical Contracts

 

Jim Dodds  

Supply Chair Manager

 

 

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Milestones, EV at Milestones

Consultants and Phase Project Management will earn value as Level of Effort
activities. All other costs will earn value according to the schedule below.

 

Signed Study Protocol

 

           10%       

First participant dosed

 

           20%       

40 % Enrollment

 

           35%       

70% Enrollment

 

           50%       

Last participant procedure (Treatment phase)

 

           60%       

Last participant follow-up

 

           70%       

Database lock

 

           80%       

Clinical Study Report

 

           90%       

Transferred Trial Master File

 

           100%         

Deliverables

 

  1. Signed Study Protocol

  2. Top-line data

  3. Signed Clinical Study Report

External Dependencies

 

  1. Top-line Data from an External Clinical Study Identifying Panaceomycin
Maximum Tolerated Dose as a single dose in Humans. The Maximum Tolerable Dose
will be defined in a study not included in the BARDA contract. This dose will be
used in selecting the Supra-therapeutic dose in this Thorough QT Study.

  2. Successful production of cGMP lot of Panaceomycin.

  3. Enrollment and retention of study participants.

 

Sample WBS Dictionary

 

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Work Authorization

 

   

Project/Contract

 

  BARDA   WBS #   1.1.6.2    

WBS description

 

  Program Management, Meetings and Control    

Authorization version #

 

  1   Scheduled Start   Oct 2010   Scheduled Finish   Sep 2012

 

Work Description

 

         

 

                    staff will manage the integration and performance control of
the program.

 

For further detail, see description of scope for WBS 1.1.6.2

                                                                  Budget        
        Labor   $250,000                 Subcontractors   $                
Consultants   $                 Material   $                 Travel   $        
        Total     $250,000            

 

Approvals

 

    Control Account Manager   Name:   Benjamin Gay   Signature:       Date:    
                                                                  Project
Manager   Name:   Ronald Smith   Signature:       Date:                        
                                              Finance   Name:   Denise Blessi  
Signature:       Date:                                                          
         

 

Sample Work Authorization Document

 

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   CAP:        1.1.1 Drug Production    Month End:       3/31/2011            
  

 

Control Account

Performance

                                    Month 1     Month 2     Month 3     Month 4
    Month 5     Month 6     Month 7     Month 8     Month 9     Month 10    
Month 11     Month 12     Total      

BCWS

      200         30         30         40         60         80         60    
    80         15         25         30         25         675   

BCWP

      10         190         60                                                
                                   

ACWP

      12         190         60                                                
                                   

SV

      -190         160         30                                              
                                     

CV

      -2         0         0                                                    
                               

 

Resource Summary

                                    Month 1     Month 2     Month 3     Month 4
    Month 5     Month 6     Month 7     Month 8     Month 9     Month 10    
Month 11     Month 12     Total  

Labor

      10         10         10         10         10         10         10      
  10         10         10         10         10         120   

Sub DB

              20         20         30                                          
                              70   

Sub DP

                                      50         70         50         70      
                                  240   

Sub Pack

                                                                              5 
       20         15         40   

Material

      190                                                                      
                          190   

ODC

                                                                      5        
10                         15   

BCWS

      200         30         30         40         60         80         60    
    80         15         25         30         25         675   

 

Work Package

Summary

                                EVM       Month 1     Month 2     Month 3    
Month 4     Month 5     Month 6     Month 7     Month 8     Month 9     Month 10
    Month 11     Month 12     Total  

Sub Contract

Management

    LOE         10         10         10         10        10         10        
10         10         10         10         10         10         120   

Purchase Materials

    0/100         190                                                           
                                    190   

Manufacture Drug

Substance

    MS                 20         20         30                                
                                        70   

Manufacture Drug

Product

    MS                                         50         70         50        
70                                         240   

Ship

    Units                                                                      
  5         10                         15   

Package & Store

    Units                                                                      
          5         20         15         40   

BCWS

      200         30         30         40         60         80         60    
    80         15         25         30         25         675   

Sample Control Account Plan

 

21