Exhibit 10.1

CONFIDENTIAL TREATMENT REQUESTED

CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE BEEN REDACTED AND HAVE BEEN
SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION. INFORMATION THAT
WAS OMITTED IN THE EDGAR VERSION HAS BEEN NOTED IN THIS DOCUMENT WITH A
PLACEHOLDER IDENTIFIED BY THE MARK “[***].”

 

AWARD/CONTRACT                               

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

  u        

RATING

  PAGE    OF    PAGES      

N/A

  1       55       2. CONTRACT (Proc. Inst. Ident.) NO.  

3. EFFECTIVE DATE

  4. REQUISITION/PURCHASE REQUEST/PROJECT NO. HHSO100201500011C  

See block 20C (below)

                                                       

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

 

Pfenex Inc

10790 Roselle Street

San Diego, CA 92121

CAGE: 5UJ49

 

 

See Schedule.

 

 

9/ DISCOUNT FOR PROMPT PAYMENT

 

N/A

 

 

10. SUBMIT INVOICES

 

ADDRESS SHOWN IN: F.3

 

ITEM

 

See Section G.

CODE DUNS No. 01360371   FACILITY CODE     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 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                     

 

Title: RPA563 and Px563L Advanced Development

 

      (See Schedule)   (See Schedule)   (See Schedule)   (See Schedule) 15G.
TOTAL AMOUNT OF CONTRACT               u   $15,891,600.00 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       01   x   I   CONTRACT CLAUSES      
47     x   B   SUPPLIES OR SERVICES AND PRICE/COST       03   PART III - LIST OF
DOCUMENTS, EXHIBITS AND OTHER ATTACH. x   C   DESCRIPTION / SPECS / WORK
STATEMENT       10   x   J   LIST OF ATTACHMENTS       54     x   D   PACKAGING
AND MARKING       11   PART IV - REPRESENTATIONS AND INSTRUCTIONS x   E  
INSPECTION AND ACCEPTANCE       11   x   K   REPRESENTATIONS, CERTIFICATIONS AND
OTHER STATEMENTS OF OFFERORS       55     x   F   DELIVERIES OR PERFORMANCE    
  12           x   G   CONTRACT ADMINISTRATION DATA       22   ¨                
x   H   SPECIAL CONTRACT REQUIREMENTS       29   ¨                 CONTRACTING
OFFICER WILL COMPLETE ITEM 17 OR 18 AS APPLICABLE

17.   x  CONTRACTOR’S NEGOTIATED AGREEMENT (Contractor is required to sign this
document and return 2 copies to issuing office.) Contractor agrees to furnish
and deliver all items or perform all the services set forth or otherwise
identified above and on any continuation sheets for the consideration stated
herein. The rights and obligations of the parties to this contract shall be
subject to and governed by the following documents: (a) this award/contract, (b)
the solicitation, if any, and (c) such provisions, representations,
certifications, and specifications, as are attached or incorporated by reference
herein. (Attachments are listed herein.)

 

 

18.   ¨  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)

 

Dr. Bertrand C. Liang

 

20A. NAME OF CONTRACTING OFFICER

Francine Hemphill

19B.  NAME OF CONTRACTOR

    19C. DATE SIGNED      

20B. UNITED STATES OF AMERICA

    20C. DATE SIGNED              

 

  8/14/15

       

 

  8/14/15

 

  /s/ Bertrand Liang

      BY  

     /s/ Francine Hemphill

     

 (Signature of person authorized to sign)

 

             

  (Signature of Contracting Officer)

 

           

 

  NSN 7540-01-152-8069

  PREVIOUS EDITION UNUSABLE

  

26-107

Computer Generated

  

STANDARD FORM 26 (REV. 4-85)        

 

      Prescribed by GSAFAR (48 CFR) 53.214(a)        

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

 

1

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Contents

 

PART I – THE SCHEDULE

 

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

    3   

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

    9   

SECTION D – PACKAGING, MARKING AND SHIPPING

    11   

SECTION E – INSPECTION AND ACCEPTANCE

    11   

SECTION F – DELIVERIES OR PERFORMANCE

    12   

SECTION G - CONTRACT ADMINISTRATION DATA

    22   

SECTION H - SPECIAL CONTRACT REQUIREMENTS

    30   

PART II - CONTRACT CLAUSES

 

SECTION I - CONTRACT CLAUSES

    50   

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

 

SECTION J - LIST OF ATTACHMENTS

    57   

PART IV - REPRESENTATIONS AND INSTRUCTIONS

 

SECTION K - REPRESENTATIONS AND CERTIFICATIONS

    58   

 

 

HHSO100201500011C

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

 

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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

The Biomedical Advanced Research and Development Authority (BARDA) seeks to
support the advanced research and development of a next generation anthrax
vaccine that provides significant advantages over the currently licensed Anthrax
Vaccine Adsorbed (AVA), or BioThrax®. BioThrax generates a rather low level
immune response, thereby requiring multiple doses, and the manufacturer has
struggled to improve productivity to the level necessary to fulfill the
requirements of the US Strategic National Stockpile.

The referenced BAA states that the next generation anthrax vaccine must include
one or more of the following advantages: fewer doses to protection; faster
protective immune response; and/or improved storage conditions (e.g. avoidance
of cold chain). Through its previous and ongoing work with BARDA’s Division of
Strategic Science and Technology (SST).

Pfenex Inc. (Pfenex) has developed two potential vaccine candidates based on the
production of a stable mutant variant of recombinant Protective Antigen from
Bacillus anthracis (mrPA), antibodies to which are correlated with protection
from anthrax disease. Pfenex believe that one or both of the vaccine candidates
potentially possess one or more of the advantages sought by BARDA, and thus
would fulfill the target profile the government seeks for the next generation
recombinant anthrax vaccine.

The Pfenex approach has combined two different efforts to create an improved
vaccine candidate. First, Pfenex has investigated mutant rPA antigen identified
at the National Institutes of Health (NIH). This antigen, deemed mrPA, lacks
specific protease cleavage sites resulting in a more stable antigen yet produces
a robust immune response in animals. Second, using the protein expression
platform technology, Pfēnex Expression Technology™, have produced mrPA in a
specific dual protease-deficient Pseudomonas fluorescens strain, resulting in a
scalable fermentation process with titers of properly folded antigen up to [***]
and a purification process that can produce multiple grams per liter of purified
antigen. Every gram of purified mrPA can potentially produce [***] doses of
vaccine assuming [***]. Thus, with the successful development of a highly
productive expression strain and production process for mrPA, Pfenex has
developed a solution to specifically address the historical challenges related
to the low production of recombinant Protective Antigen (rPA), thus potentially
allowing the fulfillment of the Strategic National Stockpile statutory
requirements.

The Advanced Research and Development effort will progress in specific stages
that cover the base work segment and the eight (8) option work segments. Work
performed during the base segment and in the eight (8) option segments each
constitutes an independent, non-severable discrete work segment that cannot be
subdivided for separate performance. Work specified in each work segment is
necessary to support the development of recombinant Protective Antigen (rPA) as
an MCM. Each of the non-severable, discreet work segments contains multiple
activities that when reviewed in total shall satisfy a defined end-product for
each segment. The Government has determined that it has a Bona Fide Need for
each non-severable discrete work segment. That need will be met upon the
completion of the defined task(s) listed in the Work Breakdown Statement (WBS)
in the Statement of Work (SoW) for each work segment (See Section J-Attachment
1), the completion of the Milestones in the Contract and submission of the
deliverables required in the Contract (See Section J–Attachment 2.). Each work
segment provides independent merit and value to the Government. Each work
segment will be fully funded from an appropriation source that is current at the
time the contract is awarded (Base Work Segment) and at the time the Government
exercises each option.

ARTICLE B.2. BASE PERIOD (August 13, 2015, through February 12, 2018)

 

 

HHSO100201500011C

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

 

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  a. The total estimated cost of the base period of the contract excluding fee
is [***].

 

  b. The total fixed fee for the base period of performance is [***]

 

  c. The fixed fee for the base period of performance (CLIN 0001) and any
exercised cost-reimbursement contract options shall be paid at a rate equal to
[***] of actual costs incurred per invoicing period, with the balance of fee
payable upon successful completion of all work under each CLIN, up to a maximum
fee of [***] subject to the following limitations:

 

  •   The government shall withhold the payment of a portion of the fee to
protect the government’s interest as set forth in Federal Acquisition Regulation
(FAR) 52.216-8, Fixed Fee (June 2011). The government shall withhold [***] of
the total fixed fee or [***] whichever is less, until after government review
and acceptance of the Final Technical Progress Report.

 

  d. The total estimated cost of the base period of the contract, CLIN 0001,
represented by the sum of the total estimated cost plus fixed fee is
$15,891,600. 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.

 

  e. The Contractor shall maintain records of all contract costs and such
records shall be subject to FAR 52.215-2 (Oct 2010), Audit and
Records-Negotiation, and Health and Human Services Acquisition Regulation
(HHSAR) 352.242-74, Final Decisions on Audit Findings, incorporated by reference
into this contract in SECTION I.

 

CLIN

  

Estimated

Period of

Performance

  

Supplies/Services

   Total
Estimated
Cost     Fixed
Fee     Total
Estimated
Cost Plus
Fixed Fee  

0001

   08/13/2015-02/12/2018    PHASE 1A STUDY AND CONTINUATION OF STABILITY STUDIES
     [*** ]      [*** ]    $ 15,891,600   

ARTICLE B.3. OPTION PRICES

Pursuant to FAR 52.217-9, Option to Extend the Term of the Contract (Mar 2000),
set forth in full in ARTICLE I.3 of this contract, the government may, by
unilateral contract modification, require the Contractor to perform discrete
portions of additional work as specified in the Statement of Work.

Unless the government exercises one or more optional CLINs, the contract
consists only of the base work specified in the Statement of Work as defined in
SECTIONS C and F, with estimated costs set forth in ARTICLE B.2 of the contract.

 

 

HHSO100201500011C

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

 

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CLIN

   Option   

Estimated

Period of

Perf.

  

Supplies/

Services

   Total Est.
Cost     Fixed
Fee     Total Est.
Cost Plus
Fixed Fee  

0002

   1    08/12/2015-11/03/2016    [***]      [*** ]      [*** ]      [*** ] 

0003

   2    11/24/2016-02/24/2019    [***]      [*** ]      [*** ]      [*** ] 

0004

   3    05/27/2018-08/02/2020    [***]      [*** ]      [*** ]      [*** ] 

0005

   4    11/16/2015-08/19/2016    [***]      [*** ]      [*** ]      [*** ] 

0006

   5    11/24/2016 – 12/08/2017    [***]      [*** ]      [*** ]      [*** ] 

0007

   6    01/09/2016-08/05/2020    [***]      [*** ]      [*** ]      [*** ] 

0008

   7    11/24/2016-08/09/2020    [***]      [*** ]      [*** ]      [*** ] 

0009

   8    12/24/2016-05/13/2017    [***]      [*** ]      [*** ]      [*** ] 

ARTICLE B.4. LIMITATIONS APPLICABLE TO DIRECT COSTS

 

  a. Items Unallowable Unless Otherwise Provided

Notwithstanding the clause FAR 52.216-7, Allowable Cost and Payment,
incorporated in this contract, unless authorized in writing by the Contracting
Officer in the form of a Contracting Officer Authorization (COA), the costs of
the following items or activities shall be unallowable as direct costs:

 

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

 

  2. Special rearrangement or alteration of facilities;

 

  3. Purchase or lease of any item of general purpose office furniture or office
equipment regardless of dollar value. (General purpose equipment is defined as
any items of personal property which are usable for purposes other than
research, such as office equipment and furnishings, pocket calculators, etc.);

 

  4. Travel to attend general scientific meetings, subject to limitation under
Article B.4.b.1;

 

  5. Foreign travel;

 

  6. Subcontractor and/or Consultant costs;

 

 

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with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

 

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  7. Patient Care Costs;

 

  8. Accountable government property (defined as both real and personal property
with an acquisition cost of $1,000 or more and a life expectancy of more than
two years) and “sensitive items” regardless of acquisition value (Section J,
Attachment 6).

 

  9. Printing Costs (as defined in the government Printing and Binding
Regulations).

 

  10. Light Refreshment and Meal Expenditures are not authorized.

 

  11. Costs for meeting room or conference space used for face to face meetings
with United States government (USG) staff in the performance of this contract at
Government or Contractor facilities are not authorized.

 

  b. Travel Costs

 

  1. Total expenditures for all travel (transportation, lodging, subsistence,
and incidental expenses) incurred by the Prime Contractor in direct performance
of this contract during the base period shall not exceed [***] without the prior
written approval of the Contracting Officer. Cost must be consistent with FAR
52.247-63 – Preference for U.S. - Flag Air Carriers.

 

  2. The Contactor shall invoice and be reimbursed for all travel costs in
accordance with FAR 31.205-46, Travel Costs and GSA Per Diem Rates
(www.gsa.gov/perdiem).

 

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

(i) meeting(s) and place(s) to be visited, with costs and dates;

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

(iii) contract purpose to be served by the travel;

(iv) how travel of Contractor personnel will benefit and contribute to
accomplishing the contract project, or will otherwise justify the expenditure of
AMCG contract funds;

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

(vi) what additional functions may be performed by the travelers to accomplish
other purpose of the contact and thus further benefit the project.

ARTICLE B.5. ADVANCE UNDERSTANDINGS

 

  a. Subcontracts

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

Is of the cost-reimbursement type or Time-and-Materials (T&M);

Is Fixed-Price and exceeds [***] or [***] of the total estimated cost of the
Contract.

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

 

 

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with the Securities and Exchange Commission. Confidential treatment has been
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provided to the Contracting Officer within ten (10) calendar days.

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

 

  b. Security

The contractor is required to secure an approved Security Plan unless an
approved waiver is obtained for this effort. A security waiver may be requested
through the Contracting Officer. In the event a security waiver cannot
successfully be attained, the Government will notify the Contractor who will
subsequently be required to deliver a security plan to the Government,
conforming within the following paragraphs.

The work to be performed under this contract will involve access to sensitive
Biomedical Advanced Research and Development Authority [BARDA] program
information. Upon contract award, the Program Protection Officer (PPO) will
request submission of and review the Draft Security Plan in detail and submit
comments within ten (10) business days to the CO to be forwarded to the
Contractor. The Contractor shall review the Draft Security Plan comments, and if
changes are required, submit a Final Security Plan to the U.S. Government within
thirty (30) calendar days after receipt of the Program Protection Officer’s
(PPO) comments. The Final Security Plan shall include a timeline for compliance
of all the required security measures. Upon completion of initiating all
security measures, the Contractor shall supply to the CO and Contracting
Officer’s Representative (COR) a letter certifying compliance to the elements
outlined in the Final Security Plan. The execution of the work under this
contract shall be in accordance with the approved Final Security Plan. The
Contractor shall ensure that the storage, generation, transmission or exchanging
of BARDA sensitive information has the appropriate security controls in place.
At a minimum, the Final Security Plan shall address the following items:

Personnel Security Policies and Procedures including, but not limited to:
Recruitment of new employees; Interview process; Personnel background checks;
Suitability/adjudication policy; Access determination; Rules of
behavior/conduct; Termination procedures; Non-disclosure agreements.

Physical Security Policies and Procedures including but not limited to:
Internal/external access control; Identification/badge requirements; Facility
visitor access; Parking areas and access; Barriers/perimeter fencing; Shipping,
receiving and transport (on and off- site); Security lighting; Restricted areas;
Signage; Intrusion detection systems; Closed circuit television; Other control
measures.

Information Security Policies and Procedures including but not limited to:
Identification of sensitive information; Access control/determination; Secured
storage infrastructure; Document control; Retention/destruction requirements.

Information Technology Security Policies and Procedures including but not
limited to: Intrusion detection and prevention systems; firewalls, Encryption
systems; Identification of sensitive information/media; Passwords; Removable
media; Laptop policy; Media access control/determination; Secure storage; System
document control; System backup; System disaster recovery.

Security Reporting Requirement - Violations of established security protocols
shall be reported to the CO and COR within 24 hours of the contractor’s
discovery of any compromise, intrusion, loss or interference of its security
processes and procedures. The Contractor shall ensure that all software
components that are not required for the operation and maintenance of the
database/control system have been removed and/or disabled. The Contractor shall
provide to the CO and the COR information appropriate

 

 

HHSO100201500011C

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with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

 

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to Information and Information Technology software and service updates and/or
workarounds to mitigate all vulnerabilities associated with the data and shall
maintain the required level of system security.

The Contractor will investigate violations to determine the cause, extent, loss
or compromise of sensitive program information, and corrective actions taken to
prevent future violations. The CO in coordination with BARDA will determine the
severity of the violation. Any contractual actions resulting from the violation
will be determined by the Contracting Officer.

 

  c. Confidential Treatment of Sensitive Information

The Contractor shall, to the extent permitted by law, guarantee strict
confidentiality of sensitive/confidential information/data that is provided by
the USG during the performance of the contract. The USG has determined that
certain information/data that the Contractor will be provided during the
performance of the contract is of a sensitive nature.

Disclosure of confidential/sensitive information/data, in whole or in part, by
the Contractor can only be made after the Contractor receives prior written
approval from the Contracting Officer. Whenever the Contractor is uncertain with
regard to the proper handling of information/data under the contract, the
Contractor shall obtain a written determination from the Contracting Officer.

Notwithstanding the foregoing, such information/data shall not be deemed of a
sensitive or confidential nature with respect to the Contractor for purposes of
this contract if such information/data: (a) was already known to the Contractor
other than by prior disclosure by the USG or discovered through work under a
prior USG contract; (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 USG 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 USG.

The Contractor may disclose information/data of a sensitive nature provided by
the USG to the extent that such disclosure is: (a) made in response to a valid
order of a court of competent jurisdiction (b) otherwise required by law or
regulation, (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.

 

  d. 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 Advisory
Committee (PAC) Charter, and agreements between BARDA and the Department of
Defense and the National Institutes of Health, BARDA may share technical
deliverables and data created in the performance of this contract with
colleagues within the Integrated Portfolio. This advance understanding does not
authorize BARDA to share financial information outside of the United States
Government. The Contractor is advised to review the

 

 

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with the Securities and Exchange Commission. Confidential treatment has been
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terms of FAR 52.227-14, Rights in Data – General, regarding the government’s
rights to deliverables submitted during performance as well as the government’s
rights to data contained within those deliverables.

 

  e. Review of Protocols

The Contractor shall submit all protocols as referenced under this Contract to
the COR for review. The Government requires no fewer than eight (8) business
days to perform a review. The Contractor shall take this review time into
account and submit protocols as early as possible to avoid delays. The
Government’s comments and feedback shall be addressed prior commencement of the
studies. The Contractor shall not commence with studies until a mutual agreement
has been reached with the Government on the protocol(s).

 

  f. Limited Rights Data

The contract incorporates the Alternate II to FAR Clause 52.227-14, Rights in
Data—general, pursuant to FAR Clause 52.227-14 (g)(3). In the event that the
U.S. Government requires the delivery of pre-existing privately funded data,
Pfenex, will identify that specific pre-existing privately funded data and that
data will be marked with the limited rights notice specified under FAR Clause
52.227-14 (g)(3)(a).

 

  g. FDA Submissions

“Except as noted in Section B.5.e above with respect to the original protocol
submission, any documents and/or reports that need to be provided to the FDA,
but are not generated under this contract, are exempt from the time required for
BARDA’s review. However, BARDA must be notified in advance of documents and/or
reports being submitted.”

 

  h. Access Limitations

The US Government may only conduct or participate in audits, site visits and
inspections and require delivery of documentation hereunder of activities funded
by this contract.

 

  i. Clinical Hold Costs

Notwithstanding the provisions of Article H.1.2.iii below, the parties agree
that Contractor may use contract funds during a clinical hold for activities
related to patients coming off the study, monitoring of patients, winding down
the study or for developing a plan and completing the activities to address the
issues that caused or contributed to the clinical hold.

 

  j. [***]

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

Independently and not as an agent of the government, the Contractor shall
furnish all the necessary services, qualified personnel, material, equipment,
and facilities not otherwise provided by the government as needed to perform the
Statement of Work dated April 17, 2015, set forth in SECTION J - List of
Attachments, attached hereto and made a part of the contract.

 

 

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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 the contract are limited to the implementation requirements
outlined by the 7 Principles of Earned Value Management Tier 3 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.

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

ARTICLE C.4. PROJECT MEETING CONFERENCE CALLS

A conference call between the Contracting Officer’s Representative and designees
and the Contractor’s Project Leader/delegate and designees shall occur bi-weekly
or as otherwise mutually agreed upon by the USG and the Contractor or determined
by the Contracting Officer. During this call the Contractor’s Project
Leader/delegate and designees will discuss the activities since the last call,
any problems that have arisen and the activities planned until the next call
takes place. The Contractor’s Project Leader/delegate 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.
Electronic copy of conference call meeting minutes/summaries shall be provided
via e-mail to the CO, COR, and uploaded in e-room by the Contractor within five
(5) business days after the conference call is held.

ARTICLE C.5. OTHER PROJECT MEETINGS

 

  a. Kickoff Meeting

The Contractor and USG shall conduct a kickoff meeting within 30 calendar days
after contract award. Contractor shall provide an itinerary/agenda no later than
5 business days before meeting. Minutes from the kickoff meeting must be
provided within 10 business days of the event.

 

  b. Quarterly and Ad-Hoc Meetings

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 AMCG and
BARDA in Washington, D.C. and at work sites of the Contractor and
subcontractors. Such meetings may include, but are not limited to, meetings of
the Contractor to discuss study designs, site visits to the Contractor’s
facilities, and meetings with the Contractor and HHS officials to discuss the
technical, regulatory, and ethical aspects of the program. Subject to the data
rights provisions in this contract, the Contractor will provide data, reports,
and presentations to groups of outside experts and USG personnel as required by
the Contracting Officer’s Representative in order to facilitate review of
contract activities. Notwithstanding the foregoing, the USG shall ensure that
any non-USG personnel receiving such information from Contractor or the USG
shall be subject to non-disclosure agreements that require appropriate
protections for Contractor’s confidential or proprietary data. Contractor shall
provide itinerary/agenda at least 5 business days in advance of face-to-face
meeting.

 

 

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  c. Face-to-Face Project Review Meetings

The contractor shall, at a time to be determined later, present a comprehensive
review of contract progress to date in a face-to-face meeting in Washington, DC.
The contractor will be responsible for updating BARDA program on technical
progress under the Statement of Work.

Presentation must be delivered seven (7) business days prior to the scheduled
meeting.

SECTION D – PACKAGING, MARKING AND SHIPPING

All deliverables required under this contract shall be packaged, marked and
shipped in accordance with USG specifications. At a minimum, all deliverables
shall be marked with the contract number and Contractor name.

Unless otherwise specified by the Contracting Officer, delivery of reports to be
furnished to the USG under this contract (including invoices) shall be delivered
to AMCG and BARDA electronically along with a concurrent email notification to
the Contracting Officer, Contract Specialist, and COR (as defined in SECTION
F.3. ELECTRONIC SUBMISSION) summarizing the electronic delivery.

SECTION E – INSPECTION AND ACCEPTANCE

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

This contract incorporates the following clauses by reference, with the same
force 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 these addresses:
https://www.acquisition.gov/FAR/. HHSAR Clauses at:
http://www.hhs.gov/policies/hhsar/subpart352.html.

 

FAR Clause

  

Title and Date

52.242-15    Stop Work Order (Aug 1989) 52.246-9    Inspection of Research and
Development (Short Form) (Apr 1984)

ARTICLE E.2. DESIGNATION OF GOVERNMENT PERSONNEL

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

ARTICLE E.3. INSPECTION, ACCEPTANCE AND CONTRACT MONITORING

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

Inspection and acceptance will be performed at:

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

 

 

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Independence Avenue, S.W., Room G644 Washington, D.C. 20201

 

  a. Site Visits and Inspections

At the discretion of the USG and independent of activities conducted by the
Contractor, with 48 hours’ notice to the contractor, the USG reserves the right
to conduct site visits and inspections on an as needed basis including
collection of product samples and intermediates held at the location of the
contractor, or subcontractor. All costs reasonably incurred by the Contractor
and subcontractor for such visit and/or inspection shall be allowable costs
subject to the Allowable cost requirements in FAR Subpart 31.2. The Contractor
shall coordinate these visits and shall have the opportunity to accompany the
USG on any such visits. Under time-sensitive or critical situations, the USG
reserves the right to suspend the 48 hour notice to the Contractor. The areas
included under the site visit could include, but are not limited to: security,
regulatory and quality systems, manufacturing processes and cGMP/GLP/GCP
compliance.

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

 

  •   If issues are identified during the audit, the Contractor shall submit a
report to the CO and COR within five (5) business days detailing the finding and
corrective action(s) of the audit.

 

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

 

  •   Once corrective action is completed, the Contractor will provide a final
report to the CO and COR.

SECTION F – DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

Base Period

Under CLIN 0001, the estimated period of performance for the base performance
segment of this contract shall be from August 13, 2015 through February 12, 2018
(18 months).

Option CLINs

 

CLIN

  

Option

  

Estimated Period of Performance

  

Supplies/Services

0002    1    08/12/2015-11/03/2016    SEE ATTACHMENT 2 0003    2   
11/24/2016-02/24/2019    SEE ATTACHMENT 2 0004    3    05/27/2018-08/02/2020   
SEE ATTACHMENT 2 0005    4    11/16/2015 – 08/19/2016    SEE ATTACHMENT 2 0006
   5    11/24/2016 – 12/08/2017    SEE ATTACHMENT 2

 

 

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0007    6    01/09/2016 – 08/05/2020    SEE ATTACHMENT 2 0008    7   
11/24/2016-08/09/2020    SEE ATTACHMENT 2 0009    8    12/24/2016-05/13/2017   
SEE ATTACHMENT 2

NOTE: Base period and all option periods (if exercised in accordance with FAR
clause FAR clause 52.217-09, Option to Extend the Term of the Contract (Mar
2000), shall not exceed sixty (60) months.

ARTICLE F.2. DELIVERABLES

Successful performance of the final contract shall be deemed to occur upon
completion of performance of the work set forth in the Statement of Work dated
April 17, 2015, 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, of each of the deliverables described in SECTION C,
SECTION F, and SECTION J, Attachment 2, “Contract WBS Milestones and Related
Deliverables”.

All deliverables and reporting documents listed within this section shall be
delivered electronically (as defined in SECTION F.3. ELECTRONIC SUBMISSION) to
the CO, CS, and the COR unless otherwise specified by the Contracting Officer.

 

  a. Summary of Contract Deliverables

Unless otherwise specified by the Contracting Officer, the deliverables
identified in this SECTION F shall also be delivered electronically to the
designated eRoom along with a concurrent email notification sent to the
Contracting Officer, Contract Specialist, COR, and Alternate COR stating
delivery has been made.

All paper/hardcopy documents/reports submitted under this contract shall be
printed or copied, double-sided, on at least 30 percent post-consumer fiber
paper, whenever practicable, in accordance with FAR 4.302(b). Hard copies of
deliverables and reports furnished to the USG under the resultant Contract
(including invoices) shall be addressed as follows:

HHS/ASPR/AMCG

ATTN: Francine Hemphill, Contracting Officer 330

Independence Avenue, S.W., Room G640

Washington, DC 20201

Email: Francine.hemphill@hhs.gov

HHS/ASPR/BARDA

ATTN: Daniel Wolfe, Contracting Officer’s Representative

330 Independence Avenue, S.W., Room G640

Washington, DC 20201

Email: Daniel.wolfe2@hhs.gov

 

 

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Technical Reports

Item

  

Deliverable

  

Description

  

Deliverable Schedule

1    Bi-weekly Teleconference and Meeting Minutes    The Contractor shall
prepare minutes of all “Project Meetings and “Project Meeting Conference Calls”
as defined in Article C. of this contract. In preparation for bi-weekly calls,
briefing materials, including the agenda and documents and information to be
discussed will be prepared as needed.   

Contractor shall provide teleconference agenda and related materials twenty-four
(24) hours in advance of the call.

 

Contractor provides meeting minutes to COR within five (5) business days of the
meeting. COR reviews, comments, and approves minutes within 15 business days of
receipt.

2    Draft Security Plan    Draft Security Plan as detailed in Article B.5.d.   
Within 10th calendar days following the effective date of the contract 3   
Monthly Technical Progress Report and Invoice    Monthly Progress report shall
address the progress occurring over the corresponding period of time. See below,
ARTICLE F.2.(b), “Detailed Description of Select Contract Deliverables,” for
detailed instructions. Additionally, submission of the Monthly Technical
Progress Report will contain the invoice for actual costs incurred during the
previous month that work was performed under the contract. The costs incurred in
the invoice will be justified in a summary report contained within the Monthly
Technical Progress Report.    The 20th calendar day of each month following the
first full month of the contract award. The Monthly Progress Report will not be
required in months when an Annual or Final Technical Progress Report is due. 4
   Annual Progress Report    Annual Progress report shall address the progress
occurring over the corresponding period of time. See below, Article F.2.(b),
“Detailed Description of Select Contract Deliverables,” for detailed
instruction.    The 15th calendar day of the month following the end of each
12-month performance period. The Monthly Progress Report will not be required in
months when an Annual Progress report is due 5   

In-Process Review (GO/NO GO

Decision Gate) Presentation

   In preparation for the IPR, the Contractor shall prepare a presentation
demonstrating the technical progress made towards completion of the tasks under
each work segment. The presentation shall demonstrate the status or completion
of the milestones and deliverables as specified under Section F and Attachment
J.2.   

The presentation must be submitted to the CO/COR thirty (30) business days prior
to the IPR IPR for BARDA review and comment. Subsequently, a revised/final
presentation will be required ten (10) business days prior to the IPR.

 

The CO will provide a written response within ten (10) business days on the
decision to exercise or not exercise an option.

 

 

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6    Earned Value Management Report    As described in Article C.3.    The 20th
calendar day of each month following the first full month of the contract award.
7    Draft Final Technical Progress Report    A draft Final Report containing a
summation of the work performed under each task and subtask and the results
obtained for the entire contract Period of Performance (PoP). The draft report
shall be duly marked as “Draft.” BARDA will provide comments that the Contractor
shall incorporate into the Final Technical Progress Report.    Forty-five (45)
calendar days before the completion date of the contract. 8    Final Technical
Progress Report    A Final Report containing a summation of the work performed
and the results obtained for the entire contract Period of Performance (PoP).   
Thirty (30) calendar days after the end of the technical period of performance.
9    Summary of Salient Results    Contractor shall submit, with the Final
Report, a summary (not to exceed 200 words) of salient results achieved during
the performance of the contract.    On or before the expiration date of the
contract. 10    Deviation Notification. Changes to Execution of Planned Tasks
and Mitigation Strategy    In order to process for changing tasks, including
activities associated with task content, cost and schedule per IMP/Gantt
baseline, the Contractor shall notify the Government of significant changes,
justification, and rationale for proposed alternative in writing. Cost
reallocation and reconciliation of the budget should be included. Contractor
shall provide a high-level management strategy for risk mitigation and update
the Risk Management Plan   

Notice due within 1 week after discovery or need for changes to product
development plan per Gantt identified.

 

Contractor shall revise the IMP/Gantt within thirty (30) calendar days, update
monthly s part of the Monthly Progress Report, and update the Risk Management
Plan.

 

Contractor must address, in writing, all concerns raised by BARDA and re-submit
a IMP/GANTT that reflects or addresses BARDA’s concerns.

11    Development Report    Final Reports detailing the parameters and capacity
of upstream and downstream conditions.    Upon successful completion.

 

Other Technical Reports

Item

  

Deliverable

  

Deliverable Schedule

12    Audit Reports    Within fifteen (15) calendar days of the audit (see
F.2.b.4 below) 13   

FDA/Regulatory Agency

 

Correspond. & Meeting Summaries

   Within five (5) business days of each meeting for Contractor’s minutes and
upon receipt of minutes from FDA/regulatory agency.

 

 

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14    FDA/Regulatory Agency Submissions   

BARDA shall provide comment within five (5) business days after receipt. BARDA
reserves the right to request more than 5 business days for review of any
regulatory submission that is of significant length.

 

The Contractor shall inform BARDA of the anticipated submission length so BARDA
can make a determination if more than 5 business days will be needed to complete
its review of the document.

15    Supplemental Technical Documents   

Upon request. Contractor shall provide CO and COR with deliverables from the
following contract funded activities: Process Development Reports; Stability
Assay Reports; Assay Qualification Plan/Report; Assay Validation Plan/Report;
Assay Technology Transfer Report; Batch Records; Contractor/

 

Subcontractor Standard Operating Procedures (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 nonproprietary technical document
for distribution within the USG.

 

Contractor shall provide technical document within 5 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.

16   

Invention Report

 

Annual Utilization Report

   Due on or before the 30th of the month following each 12-month period of
performance. 17    Final Invention Report    Due on or before the completion
date of the contract. 18    Kickoff Meeting    Within thirty (30) calendar days
of contract award.

 

  b. Detailed Description of Select Contract Deliverables

 

  1. Monthly Progress Report

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

The Contractor shall submit a Monthly Progress Report on or before the 15th
calendar day following the last day of each reporting period and shall include
the following:

A cover page that includes the contract number and title; the type of report and
period that it covers; the Contractor’s name, address, telephone number, fax
number, and e-mail address; and the date of submission;

 

 

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SECTION I - An introduction covering the purpose and scope of the contract
effort;

SECTION II – PROGRESS

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

SECTION II Part B: MANAGEMENT AND ADMINISTRATIVE UPDATE - A

description of all meetings, conference calls, etc. that have taken place during
the reporting period. Include progress on administration and management issues
(e.g. evaluating and managing subcontractor performance and personnel changes);

SECTION II Part C: TECHNICAL PROGRESS - For each activity related to the Gantt
chart, document the results of work completed and costs 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. Include progress or status updates for all SOW tasks in each
of the monthly technical progress reports for which there is activity ongoing in
that SOW task area(s) as well as data for completed studies in any SOW task. The
report shall also include a description of problems encountered and proposed
corrective action; differences between planned and actual progress, why the
differences have occurred and what corrective actions are planned; preliminary
conclusions resulting from analysis and scientific evaluation of data
accumulated to date under the project.

SECTION II Part D: PROPOSED WORK - A summary of work proposed for the next
reporting period and preprints/reprints of papers and abstracts, and a
current/updated Gantt chart.

SECTION II Part E: Outstanding Issues/Anticipated Areas of Concern - a list of
any existing contractual concerns that impact the technical scope of work,
schedule, or cost, as well as a list of potential or anticipated areas of
concern that may be encountered in the future months.

A Monthly Progress Report will not be required in the same month that the Annual
or Final Technical Progress Reports are submitted.

 

  2. Annual Progress Reporting Requirement

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

The Contractor shall submit an Annual Progress Report on or before the 15th
calendar day following the last day of each reporting period and shall include
the following:

A cover page that includes the contract number and title; the type of report and
period that it covers; the Contractor’s name, address, telephone number, fax

 

 

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number, and e-mail address; and the date of submission;

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

SECTION II-PROGRESS

SECTION II Part A: OVERALL PROGRESS - A description of overall progress
highlighting the significant accomplishments in the past year;

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, 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. The report should summarize progress made under each SOW
task.

SECTION II Part D: PROPOSED WORK - A summary of work proposed for the next
reporting period; and preprints/reprints of papers, abstracts and a current
Gantt chart.

A Monthly and Annual Progress Report will not be required for the period when
the Final Technical Progress Report is due and a Monthly Progress Report will
not be required in the same month that the Annual Progress Report is submitted.

Draft Final Technical Progress Report and Final Technical Progress Report

These reports are to include a summation of the work performed and results
obtained for the entire contract period of performance, detailing
accomplishments for each task. This report shall be in sufficient detail to
describe comprehensively the results achieved. The Draft Final Report and Final
Report shall be submitted in accordance with the DELIVERIES Article in SECTION F
of the contract. The Draft Final Technical Progress Report shall be submitted
forty-five (45) calendar days before completion date of the contract and the
Final Technical Progress Report shall be submitted 30 Calendar days post
technical period of performance. The report shall conform to the following
format:

Cover page to include the contract number, contract title, performance period
covered, Contractor’s name and address, telephone number, fax number, e-mail
address and submission date;

 

 

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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.;

SECTION II: RESULTS - A detailed description of the work performed related to
the 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.

Draft Final Technical Progress Report: The Contractor is required to submit the
Draft Final Technical Progress Report to the Contracting Officer’s
Representative and Contracting Officer. This report is due forty-five
(45) calendar days before the completion date of the contract. The Contracting
Officer’s Representative and Contracting Officer will review the Draft Final
Technical Progress Report and provide the Contractor with comments within
fifteen (15) calendar days after receipt.

Final Technical Progress Report: The contractor shall incorporate all BARDA
comments into the Final Technical Progress Report. The Contractor will deliver
the final version of the Final Technical Progress Report 30 Calendar days post
technical period of performance.

 

  3. Summary of Salient Results

On or before the expiration of the contract the Contractor shall submit, with
the Final Technical Progress Report, a summary (not to exceed 200 words) of
salient results achieved during the performance of the contract.

 

  4. Audit Reports

Within fifteen (15) calendar days of receipt of an audit report 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.

 

  5. Copies of FDA/Regulatory Agency Correspondence and Meeting Summaries

 

  •   Within five business days of any formal meeting with the FDA or other
regulatory agency, the contractor shall forward the initial draft minutes to
BARDA. The contractor shall forward final draft minutes when available.

 

  •   Within five business days of any informal meeting with the FDA or other
regulatory agency, the contractor shall forward the final draft minutes to
BARDA.

 

  •   The contractor shall forward the dates and times of any meeting with the
FDA and other regulatory agencies to BARDA and make arrangements for appropriate
BARDA staff to attend the meetings.

 

  •  

The contractor shall provide BARDA the opportunity to review and comment upon
any documents to be submitted to the FDA or other regulatory agency. The
contractor shall provide BARDA with five (5)

 

 

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business days in which to review and provide comments back to the contractor
prior to the contractor’s submission to the FDA.

 

  •   The contractor shall forward Standard Operating Procedures (SOPs) upon
request from Project Officer/Contracting Officer.

 

  •   The contractor shall provide upon request animal study and/or other
technology packages developed under this contract. Packages shall include
complete protocols and critical reagents for animal models developed and/or
improved with contract funding.

 

  •   The contractor shall provide upon request raw data and/or specific
analysis of data generated with USG funds.

 

  6. Other Reports/Deliverables

 

  •   Government Rights in Data and Inventions

Technology packages developed under the contract that include complete protocols
and critical reagents developed and/or improved with contract funding must be
submitted at the request of the Contracting Officer’s Representative.

 

  •   Institutional Biosafety Approval

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

 

  •   Experimental Protocols

The Contractor shall submit all study/experiment/test plans, designs, and
protocols.

 

  7. Data

The Contractor shall provide data and/or specific analysis of data generated
with contract funding at the request of the Contracting Officer’s
Representative.

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 ASPR after EVM is
implemented. 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.

 

  •  

Contractor shall provide EVM/CPR as part of the Monthly Progress Report (this
requirement begins only as set forth in the Contract Milestones &

 

 

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Related Deliverables table)

 

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

 

  •   In accordance with FAR 52.215-2, Audit and Records-Negotiation (Oct 2010),
the USG may request, on a monthly or ad hoc basis that the Contractor provide
raw data at a reporting level or lower level as ASPR deems necessary.

 

  •   Contractor must address, in writing, all concerns raised by the USG.

 

  •   Reporting will commence after the EVM system has been implemented but no
later than six (6) 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 180 days of contract award
with final due 8 months after award and updated monthly as part of the Monthly
Progress Report

 

  •   Contractor must address, in writing, all concerns raised by the USG.

 

  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 one year 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

 

  •   ASPR 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.

 

 

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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

 

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

 

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

 

  v. Requirement for Notification of Deviation and Mitigation Strategy

Process for changing IMS activities associated with cost and schedule as
baseline at the PMBR. Contractor shall notify ASPR of significant changes to the
IMS defined as increases in cost above 10% for a CLIN or schedule slippage of
more than 180 days, which would require an extension to the period of
performance of the CLIN. Contractor shall provide a high level management
strategy for risk mitigation within five (5) business days after discovery.
Notice due within one (1) business days after discovery.

ARTICLE F.3. ELECTRONIC SUBMISSION

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

ARTICLE F.4. SUBJECT INVENTION REPORTING REQUIREMENT

All reports and documentation required by FAR Clause 52.227-11, Patent
Rights-Ownership by the Contractor, including, but not limited to, the invention
disclosure report, the confirmatory license, and the government support
certification, one copy of an annual utilization report, and a copy of the final
invention statement, shall be submitted to the Contracting Officer. A final
invention statement (see FAR 27.303 (b)(2)(ii)) shall be submitted to the
Contracting Officer on the expiration date of the contract.

Reports and documentation submitted to the Contracting Officer shall be sent 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.

SECTION G - CONTRACT ADMINISTRATION DATA

 

 

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ARTICLE G.1. CONTRACTING OFFICER

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

Francine Hemphill

Contracting Officer

HHS/ASPR/AMCG

330 Independence Avenue, S.W. Room G644

Washington, D.C. 20201

((202) 205-9271

francine.hemphill@hhs.gov

 

1) The Contracting Officer (CO) is the only individual who can legally commit
the USG 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 USG under this contract. Only the Contracting Officer has authority to
(1) direct or negotiate any changes in the statement of work; (2) modify or
extend the period of performance; (3) change the delivery schedule;
(4) authorize reimbursement to the Contractor 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 USG may unilaterally change the CO or CS designation.

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

The following COR and Alternate COR will represent the government for the
purpose of this contract:

COR:

Daniel Wolfe, Ph.D. Division of CBRN Countermeasures

Biomedical Advanced Research and Development Authority

Assistant Secretary for Preparedness and Response

U.S. Department of Health & Human Services

Daniel.wolfe2@hhs.gov

(202) 205-8968

Alternate COR:

Adam M. Clark, Ph.D.

Division of Strategic Science and Technology

Biomedical Advanced Research and Development Authority (BARDA)

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

U.S. Department of Health and Human Services

Email: adam.clark@hhs.gov

(202) 660-1081

 

 

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Mailing Address:

330 Independence Avenue, SW G644

Washington, D.C. 20201

The COR is responsible for:

 

1) 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 USG may unilaterally change the COR designation after which it
will notify the Contractor in writing of such change.

ARTICLE G.3. KEY PERSONNEL

The key personnel specified in this contract are considered to be essential to
work performance. At least 30 days prior to diverting any of the specified
individuals to other programs or contracts (or as soon as possible, if an
individual must be replaced, for example, as a result of leaving the employ of
the Contractor), the Contractor shall notify the Contracting Officer and shall
submit comprehensive justification for the diversion or replacement request
(including proposed substitutions for key personnel) to permit evaluation by the
USG of the impact on performance under this contract. The Contractor shall not
divert or otherwise replace any key personnel without the written consent of the
Contracting Officer. The USG may modify the contract to add or delete key
personnel at the request of the Contractor or USG.

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

 

Name

  

Title

[***]    [***] [***]    [***] [***]    [***]

ARTICLE G.4. CONTRACT FINANCIAL REPORT

 

  a. Financial reports on the attached Financial Report of Individual
Project/Contract shall be submitted by the Contractor to the CO with a copy to
the COR in accordance with the instructions for completing this form, which
accompany the form, in an original and one electronic copy, not later than the
30th business day after the close of the reporting period. The line entries for
subdivisions of 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 the instructions for completing this form, all
columns A through J, shall be completed for each report submitted.

 

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

 

 

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  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 as a
part of this contract and can be found under SECTION J Attachment 4 entitled,
“Financial Report of Individual Project/Contract,”.

 

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

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

Include Program Support Center (PSC) in Receipt of Invoices:

Documents shall be delivered electronically to the Contracting Officer (CO), the
Contracting Specialist (CS), the Contracting Officer’s Representative (COR) and
PSC. Unless otherwise specified by the Contracting Officer all deliverables and
reports furnished to the Government under the resultant contract (including
invoices) shall be addressed as follows:

 

Francine Hemphill

Contracting Officer

HHS/ASPR/AMCG

330 Independence Ave., S.W.,

Room G640

Washington, DC 20201

Email: Francine.hemphill@hhs.gov

  

Daniel Wolfe

Contracting Officer Representative

HHS/ASPR/BARDA

330 Independence Ave., S.W.,

Room G640 Washington, DC 20201

Email: Daniel.wolfe2@hhs.gov

   PSC_Invoices@hhs.gov

 

  a. Contractor invoices/financial reports shall conform to the form, format,
and content requirements of the instructions for Invoice/Financing requests and
Contract Financial Reporting.

 

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

 

  c. The Contractor agrees to immediately notify the CO in writing if there is
an anticipated overrun (any amount) or unexpended balance (greater than 10
percent) of the estimated costs for the base period or any option period(s) (See
estimated costs under Articles B.2) and the reasons for the variance. These
requirements are in addition to the specified requirements of FAR Clause
52.232-20, Limitation of Cost that is incorporated by reference under Article
I.1 which states;

Limitation of Cost (Apr 1984)

(a) The parties estimate that performance of this contract, exclusive of any
fee, will not cost the Government more than (1) the estimated cost specified in
the Schedule or, (2) if this is a cost-sharing contract, the Government’s share
of the estimated cost specified in the Schedule. The Contractor agrees to use
its best efforts to perform the work specified in the Schedule and all
obligations under this contract within the estimated cost, which, if this is a
cost-sharing contract, includes both the Government’s and the Contractor’s share
of the cost.

 

 

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(b) The Contractor shall notify the Contracting Officer in writing whenever it
has reason to believe that—

(1) The costs the Contractor expects to incur under this contract in the next 60
days, when added to all costs previously incurred, will exceed 75 percent of the
estimated cost specified in the Schedule; or

(2) The total cost for the performance of this contract, exclusive of any fee,
will be either greater or substantially less than had been previously estimated.

(c) As part of the notification, the Contractor shall provide the Contracting
Officer a revised estimate of the total cost of performing this contract.

(d) Except as required by other provisions of this contract, specifically citing
and stated to be an exception to this clause—

(1) The Government is not obligated to reimburse the Contractor for costs
incurred in excess of (i) the estimated cost specified in the Schedule or,
(ii) if this is a cost-sharing contract, the estimated cost to the Government
specified in the Schedule; and

(2) The Contractor is not obligated to continue performance under this contract
(including actions under the Termination clause of this contract) or otherwise
incur costs in excess of the estimated cost specified in the Schedule, until the
Contracting Officer (i) notifies the Contractor in writing that the estimated
cost has been increased and (ii) provides a revised estimated total cost of
performing this contract. If this is a cost-sharing contract, the increase shall
be allocated in accordance with the formula specified in the Schedule.

(e) No notice, communication, or representation in any form other than that
specified in paragraph (d)(2) of this clause, or from any person other than the
Contracting Officer, shall affect this contract’s estimated cost to the
Government. In the absence of the specified notice, the Government is not
obligated to reimburse the Contractor for any costs in excess of the estimated
cost or, if this is a cost-sharing contract, for any costs in excess of the
estimated cost to the Government specified in the Schedule, whether those excess
costs were incurred during the course of the contract or as a result of
termination.

(f) If the estimated cost specified in the Schedule is increased, any costs the
Contractor incurs before the increase that are in excess of the previously
estimated cost shall be allowable to the same extent as if incurred afterward,
unless the Contracting Officer issues a termination or other notice directing
that the increase is solely to cover termination or other specified expenses.

(g) Change orders shall not be considered an authorization to exceed the
estimated cost to the Government specified in the Schedule, unless they contain
a statement increasing the estimated cost.

(h) If this contract is terminated or the estimated cost is not increased, the
Government and the Contractor shall negotiate an equitable distribution of all
property produced or purchased under the contract, based upon the share of costs
incurred by each.

 

  d.

The Contractor shall submit an electronic copy of the payment request to the
approving

 

 

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  official instead of a paper copy. The payment request shall be transmitted as
an attachment via e-mail to the address listed above in one of the following
formats: MSWord, MS Excel, or Adobe Portable Document Format (PDF). Only one
payment request shall be submitted per e-mail and the subject line of the e-mail
shall include the Contractor’s name, contract number, and unique invoice number.

 

  e. An electronic copy of the payment request shall be uploaded into the
designated eRoom (as defined in SECTION F.3 ELECTRONIC SUBMISSION) and an e-mail
notification of the upload will be provided to the CO and COR.

 

  f. All invoice submissions shall be in accordance with FAR Clause 52.232-25,
Prompt Payment (Oct 2008), Alt 1 (Feb 2002).

 

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

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

 

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

 

  b. Fringe Benefits - Cite rate and amount

 

  c. Overhead - Cite rate and amount

 

  d. Materials & Supplies - Include detailed breakdown when total amount is over
$1,000.

 

  e. Travel - Identify travelers, dates, destination, purpose of trip, and total
breaking out amounts for transportation (plane, car etc), lodging, M&IE. Cite
COA, if appropriate. List separately, domestic travel, general scientific
meeting travel, and foreign travel.

 

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

 

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

 

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

 

  i. Other Direct Costs - Include detailed breakdown when total amount is over
$1,000

 

  j. G&A - Cite rate and amount.

 

  k. Total Cost

 

  l. Fee

 

  m. Total Cost Plus Fixed Fee

Monthly invoices must include the cumulative total expenses to date, adjusted
(as applicable) to show any amounts suspended by the USG. Nothing in this
section discharges the contractor’s responsibility to comply with any applicable
FAR Parts 30 or 31 clauses’ relating to cost reimbursement subcontracts. In
order to verify allowability, further breakdown of costs may be requested at the
USG’s discretion. The Contractor shall subcontract with Firm Fixed Price
Contracts to the maximum extent practicable.

Additional instructions and an invoice template are provided in Attachment 3,
Invoice/Financing Request Instructions and Contract Financial Reporting
Instructions for Cost-Reimbursement Type Contracts. All invoices must be signed
by a representative of the contractor authorized to certify listed charges are
accurate and comply with government regulations. Invoices should be submitted
electronically (in accordance with ARTICLE F.4., (ELECTRONIC SUBMISSION) and in
hard copy with original signature.

ARTICLE G.6. INDIRECT COST RATES

 

 

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The following contractor established provisional billing rates are incorporated
into the contract, and will be utilized for billing purposes during both the
base and contract option periods pending the establishment of final indirect
cost rates for each fiscal year or until revised by the contracting officer in
accordance with the provisions of FAR 42.705-1. See FAR Clause 52.216-7.

Pfenex Inc.

 

Rate Type

  

Rate

  

Allocation Base

[***]    [***]    [***] [***]    [***]    [***] [***]    [***]    [***]

Use of the above provisional rates does not change any cost ceilings, contract
obligations, or specific allowance or disallowance provided for in the contract.

Contractor must notify the contracting officer promptly for an adjustment of the
provisional rates if it becomes evident that the rates would cause substantial
overpayment or underpayment of indirect expenses to Pfenex.

The final billing rates for each fiscal year will be based on the incurred cost
submission subject to Government audit determination. Indirect costs rate
proposals must be submitted to the cognizant agency’s Contracting Officer within
6 months subsequent to each of the contractor’s fiscal year ends. (See also FAR
Clause 52.216-7(d) (2) incorporated herein). Copies of the indirect cost
submission for each fiscal year must also be submitted to the AMCG contracting
officer, and the AMCG auditor identified as follows:

Director, Acquisition Program Support

Office of Acquisition Management, Contracts and Grants (AMCG)

Office of the Assistant Secretary for Preparedness and Response (ASPR) US
Department of Health and Human Services (DHHS)

300 Independence Avenue, SW, Room G644 Washington, DC 20201

ARTICLE G.7. REIMBURSEMENT OF COST

 

1) The USG shall reimburse the Contractor those costs determined by the
Contracting Officer to be allowable (hereinafter referred to as allowable cost)
in accordance with FAR 52.216-7, Allowable Cost and Payment and FAR Subpart
31.2. Examples of allowable costs include, but are not limited to, the
following:

 

  a) All direct materials and supplies that are used in 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

 

 

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  required under this contract subject to the restrictions under Article B.4. b.
and 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)
and must comply with the Fly America Act (49 U.S.C. 40118).

 

  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 do not exceed on a
daily basis the per diem rates set forth in the Federal Travel Regulation (FTR).

 

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

ARTICLE G.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 42.1502. 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 at least once
during the contract period of performance. The interim evaluation is expected to
be submitted on December 23, 2015.

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

The USG website for Contractor Performance Assessment Reporting System (CPARS)
is http://www.cpars.gov. Through this website Contractors may access evaluations
through a secure website for review and comment by completing the online
registration form.

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

 

 

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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

The Contractor shall identify all correspondence, reports, and other data
pertinent to this contract by imprinting the contract number HHSO100201500011C
from Page 1 of the contract.

ARTICLE G.10. OVERTIME COMPENSATION

No overtime (premium) compensation is authorized under this contract.

SECTION H - SPECIAL CONTRACT REQUIREMENTS

The Contractor, depending upon the nature of the work, is responsible for
following the provisions below in conducting its own work under this Contract.
The Contractor also is responsible for incorporating these provisions into any
subcontract awarded, if applicable to the specific nature of the work in the
subcontract. Accordingly, those provisions shall be flowed-down as applicable.

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

BARDA has a responsibility to obtain documentation concerning mechanisms 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 Contracting Officer’s Representative (COR) for evaluation and
comment.

Approval by the COR is required before work under a protocol may begin. The COR
comments will be forwarded to the Contractor within 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 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 the government. The USG will provide written authorization to the
Contractor upon either 1) receiving documentation in which all COR comments have
been satisfactorily addressed; or 2) receiving documentation that the FDA has
reviewed and commented on the protocol.

The government shall have rights to all protocols, data resulting from execution
of these protocols, and final reports funded by BARDA under this contract, as

 

 

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set forth in PART II of this contract and defined in the FAR. The government
reserves the right to request that the Contractor provide any contract
deliverable in a non-proprietary form to ensure the government has the ability
to review and distribute the deliverables as the government 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.

 

  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, is
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).

 

 

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  •   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.

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. The Contractor
should consider evaluation of clinical relevant safety markers in the pivotal
and non-pivotal, non-clinical studies. In preparation for clinical trials of
licensed or not yet licensed products, it is imperative that BARDA- sponsored
studies of any type measure 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

 

 

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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.

 

  •   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

 

 

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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 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 the Contracting Officer
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 government and the
Contractor; they apply to all grants and contracts that involve clinical
research.

 

  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

 

 

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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 and 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 (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.

 

 

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BARDA reserves the right to accompany the Contractor on site visits and/or
audits of CROs as BARDA deems necessary.

A risk is minimal where the probability and magnitude of harm or discomfort
anticipated in the proposed research and not greater than those ordinarily
encountered in daily life or during the performance of routine physical or
psychological examinations or tests. For examples, the risk of drawing a small
amount of blood from a healthy individual for research purposes is no greater
than the risk of doing so as part of a routine physical examination (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.

 

 

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

The Contractor must not use grant or contract funds during a clinical hold to
fund 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.

 

  v. 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 Contracting Officer’s Representative (COR) as follows:

 

  i. 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 the COR within 24
hours of FDA notification.

 

  ii. Expedited safety reports of serious and unexpected adverse experiences:

A copy of any report of unexpected and serious adverse experience associated
with use of an IND drug or any finding from tests 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 COR within 24
hours of FDA notification.

 

  iii. IDE reports of unanticipated adverse device effect:

A copy of any reports of unanticipated adverse device effect submitted to FDA
must be submitted to the COR within 24 hours of FDA notification.

 

  iv. Expedited safety reports:

Sent to the COR concurrently with the report to FDA.

 

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

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

 

 

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  vi. 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 Contracting Officer’s
Representative and the Contractor

ARTICLE H.2. 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-

 

 

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mail: ace@aphis.usda.gov; Web site: (http://www.aphis.usda.gov/animal_welfare).

ARTICLE H.3. 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.4. 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.5. 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

 

 

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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 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 USG to provide assurances
for the humane care of such animals.

ARTICLE H.6. 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.7. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

Anyone who becomes aware of the existence or apparent existence of fraud,

 

 

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waste and abuse in BARDA funded programs should report such matters to the HHS
Inspector General’s Office in writing or on the Inspector General’s Hotline. The
toll free number is 1-800-HHS-TIPS (1-800- 447-8477). All telephone calls will
be handled confidentially. The e-mail address is Htips@os.dhhs.gov and the
mailing address is:

Office of Inspector General

Department of Health and Human Services TIPS HOTLINE

P.O. Box 23489 Washington, D.C. 20026

ARTICLE H.8. 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.9. IDENTIFICATION AND DISPOSITION OF DATA

The Contractor will be required to provide certain data generated under this
contract to the Department of Health and Human Services (DHHS). DHHS reserves
the right to review any other data determined by DHHS to be relevant to this
contract. The contractor shall keep copies of all data required by the Food and
Drug Administration (FDA) relevant to this contract for the time specified by
the FDA.

ARTICLE H.10. EXPORT CONTROL NOTIFICATION

Contractors are responsible for ensuring compliance with all export control laws
and regulations that may be applicable to the export of and foreign access to
their proposed technologies.

Contractors may consult with the Department of State with any questions
regarding 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.11. 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 2.101 and
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

 

 

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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 USG may terminate the contract for default, debar the Contractor from USG
contracting, or pursue such other remedies as may be permitted by law or this
contract.

ARTICLE H.12. INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL
CONFLICTS OF INTEREST

The Contractor shall comply with the requirements of 45 CFR Part 94, Responsible
Prospective Contractors, which promotes objectivity in research by establishing
standards to ensure that Investigators (defined as the project director or
principal Investigator and any other person, regardless of title or position,
who is responsible for the design, conduct, or reporting of research funded
under BARDA contracts, or proposed for such funding, which may include, for
example, collaborators or consultants) will not be biased by any Investigator
financial conflicts of interest.

If the failure of an Investigator to comply with an Institution’s financial
conflicts of interest policy or a financial conflict of interest management plan
appears to have biased 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 consider
the situation and, as necessary, take appropriate action or refer the matter to
the Contractor for further action, which may include directions to the
Contractor on how to maintain appropriate objectivity in the BARDA-funded
research project.

The Contracting Officer and/or HHS may inquire at any time before, during, or
after award into any Investigator disclosure of financial interests, and the
Contractor’s review of, and response to, such disclosure, regardless of whether
the disclosure resulted in the Contractor’s determination of a financial
conflict of interests. The Contracting Officer may require submission of the
records or review them on site. On the basis of this review of records or other
information that may be available, the Contracting Officer may decide that a
particular financial 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 Institution has not managed the financial conflict of interest in
accordance with 45 CFR Part 94. 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
financial conflict of interest that was not disclosed managed or reported the
Contractor shall require the Investigator involved to disclose the financial
conflict of interest in each public presentation of the results of the research
and to request an addendum to previously published presentations.

ARTICLE H.13. NEEDLE DISTRIBUTION

 

 

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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.14. RESTRICTION ON ABORTIONS

The Contractor shall not use contract funds for any abortion.

ARTICLE H.15. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH

The Contractor shall not use contract funds for (1) the creation of a human
embryo or embryos for research purposes; or (2) research in which a human embryo
or embryos are destroyed, discarded, or knowingly subjected to risk of injury or
death greater than that allowed for research on fetuses in utero under 45 CFR
46.204(b) and Section 498(b) of the Public Health Service Act (42 U.S.C.
289g(b)). The term “human embryo or embryos” includes any organism, not
protected as a human subject under 45 CFR 46 as of the date of the enactment of
this Act, that is derived by fertilization, parthenogenesis, cloning, or any
other means from one or more human gametes or human diploid cells.

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

ARTICLE H.16. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

The Contractor shall not use contract funds to disseminate information that is
deliberately false or misleading.

ARTICLE H.17. CONFIDENTIALITY OF INFORMATION

 

  a. Confidential information, as used in this article, means information or
data of a personal nature about individual or proprietary information or data
submitted by or pertaining to an institution or organization.

 

  b. The Contracting Officer and the Contractor may, by mutual consent, identify
elsewhere in this contract specific information and/or categories of information
which the USG will furnish to the Contractor or that the Contractor is expected
to generate which is confidential and providing further that the government is
not entitled to unlimited rights to that information pursuant to FAR 52.227-14.
Similarly, the Contracting Officer and the Contractor may, by mutual consent,
identify such confidential information from time to time during the performance
of the contract. Failure to agree will be settled pursuant to the “Disputes”
clause.

 

  c. If it is established elsewhere in this contract that information to be
utilized under this contract, or a portion thereof, is subject to the Privacy
Act, the Contractor will follow the rules and procedures of disclosure set forth
in the Privacy Act of 1974, 5 U.S.C. 552a, and implementing regulations and
policies, with respect to systems of records determined to be subject to the
Privacy Act.

 

  d.

Confidential information, as defined in paragraph (a) of this article, shall

 

 

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  not be disclosed without the prior written consent of the individual,
institution, or organization.

 

  e. Whenever the Contractor is uncertain with regard to the proper handling of
material under the contract, or if the material in question is subject to the
Privacy Act or is confidential information subject to the provisions of this
article, the Contractor should obtain a written determination from the
Contracting Officer prior to any release, disclosure, dissemination, or
publication.

 

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

ARTICLE H.18. ACCESS TO DOCUMENTATION/DATA

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

ARTICLE H.19. EPA ENERGY STAR REQUIREMENTS

In compliance with Executive Order 12845 (requiring Agencies to purchase energy
efficient computer equipment), all microcomputers, including personal computers,
monitors, and printers that are purchased using USG funds in performance of a
contract shall be equipped with or meet the energy efficient low-power standby
feature as 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.20. ACKNOWLEDGMENT OF FEDERAL FUNDING

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. This requirement is in addition to the continuing requirement to
provide an acknowledgment of support and disclaimer on any publication reporting
the results of a contract funded activity.

 

A. Publication and Publicity

 

 

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No information related to data obtained under this contract shall be released or
publicized without providing BARDA with at least thirty (30) days advanced
notice and an opportunity to review the proposed release or publication.

In addition to the requirements set forth in HHSAR Clause 352.227-70,
Publications 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
Department of Health and Human Services; Office of the Assistant Secretary for
Preparedness and Response; Biomedical Advanced Research and Development
Authority, under Contract No. “HHSO100201500011C”

 

B. 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 COR has received an advance copy of any press release related to the
contract not less than six (6) business days prior to the issuance of the press
release.

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

“This project has been funded in whole or in part with Federal funds from the
Department of Health and Human Services; Office of the Assistant Secretary for
Preparedness and Response; Biomedical Advanced Research and Development
Authority, under Contract No. HHSO100201500011C.

ARTICLE H.21. IN-PROCESS REVIEW

 

 

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In Process Reviews (IPR) will be conducted at the discretion of the USG to
discuss the progression of the milestones. The USG reserves the right to revise
the milestones and budget pending the development of the project. Deliverables
such as an overall project summary report and/or slides will be required when
the IPRs are conducted. The Contractor’s success in completing the required
tasks under each work segment must be demonstrated through the Deliverables and
Milestones specified under SECTION F and Attachment J.2. Those deliverables will
constitute the basis for the USG’s decision, at its sole discretion, to proceed
with the work segment, or institute changes to the work segment, or terminate
the work segment.

IPRs may be scheduled at the discretion of the USG to discuss progression of the
contract. The Contractor shall provide a presentation following a prescribed
template which will be provided by the USG at least 30 business days prior to
the IPR. Subsequently, the contractor will be requested to provide a
revised/final presentation to the Contracting Officer at least 10 business days
prior to the IPR.

ARTICLE H.22. PROHIBITION ON THE USE OF APPROPRIATED FUNDS FOR LOBBYING
ACTIVITIES AND HHSAR 352.203-70 ANTI-LOBBYING (March 2012))

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” (March 2012)), 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.23. PRIVACY ACT APPLICABILITY

 

 

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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 USG. 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.24. LABORATORY LICENSE REQUIREMENTS

The Contractor shall comply with all applicable requirements of Section 353 of
the Public Health Service Act (Clinical Laboratory Improvement Act as amended)
(42 U.S.C. 263a and 42 CFR Part 493). This requirement shall also be included in
any subcontract for services under the contract.

ARTICLE H.25. QUALITY ASSURANCE (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 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.

ARTICLE H.26. BARDA AUDITS

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

 

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

 

  •   COR and CO 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 the CO and COR.

 

 

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ARTICLE H.27. SECURITY REPORTING REQUIREMENT

Violations of established security protocols shall be reported to the
Contracting Officer (CO) and Contracting Officer’s Representative (COR) upon
discovery and within 24 hours of any compromise, intrusion, loss or interference
of its security processes and procedures. The Contractor shall ensure that all
software components that are not required for the operation and maintenance of
the database/control system has been removed and/or disabled. The Contractor
shall provide to the CO and the COR information appropriate to Information and
Information Technology software and service updates and/or workarounds to
mitigate all vulnerabilities associated with the data and shall maintain the
required level of system security.

The Contractor will investigate violations to determine the cause, extent, loss
or compromise of sensitive program information, and corrective actions taken to
prevent future violations. The Contracting Officer in coordination with BARDA
will determine the severity of the violation. Any contractual actions resulting
from the violation will be determined by the Contracting Officer.

ARTICLE H.28. RESTRICTION ON EMPLOYMENT OF UNAUTHORIZED ALIEN WORKERS

The Contractor shall not use contract funds to employ workers described in
section 274A (h) (3) of the Immigration and National Act, which reads as
follows:

“(3) Definition of unauthorized alien – As used in this section, the term
‘unauthorized alien’ with respect to the employment of an alien at a particular
time, that the alien is not at that time either (A) an alien lawfully admitted
for permanent residence, or (B) authorized to be so employed by this Act or by
the Attorney General.”

ARTICLE H.29. NOTIFICATION OF CRITICAL PROGRAMMATIC CONCERNS, RISKS, OR
POTENTIAL RISKS

If any action occurs that creates a cause for critical programmatic concern,
risk, or potential risk to BARDA or the Contractor and 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.

ARTICLE H.31. PERSON IN PLANT

With seven (7) business days advance notice to the Contractor in writing from
the Contracting Officer, the USG may place a person-in-plant in the Contractor’s
or subcontractor’s facility, who shall be subject to the Contractor’s or
subcontractor’s policies and procedures regarding security and facility access
at all times while in the facility.

 

 

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An article substantially similar to this Person-in-Plant article shall be
incorporated into any subcontract for experimental or manufacturing work.

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 these addresses:
https://www.acquisition.gov/FAR/. HHSAR Clauses at:
http://www.hhs.gov/policies/hhsar/subpart352.html.

FEDERAL ACQUISIITON REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order Alt. 1 (1984)

Clauses for Cost-Reimbursement Research and Development Contract

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

 

FAR

CLAUSE

  

DATE

  

CLAUSE TITLE

52.202-1    Nov 2013    Definitions 52.203-3    Apr 1984    Gratuities 52.203-5
   May 2014    Covenant Against Contingent Fees 52.203-6    Sep 2006   
Restrictions on Subcontractor Sales to the government 52.203-7    May 2014   
Anti-Kickback Procedures 52.203-8    May 2014    Cancellation, Rescission, and
Recovery of Funds for Illegal or Improper Activity 52.203-10    May 2014   
Price or Fee Adjustment for Illegal or Improper Activity 52.203-12    Oct 2010
   Limitation on Payments to Influence Certain Federal Transactions 52.203-13   
Apr 2010    Contractor Code of Business Ethics and Conduct 52.203-17    April
2014    Contractor Employee Whistleblower Rights and Requirements to Inform
Employees of Whistleblower rights 52.204-4    May 2011    Printed or Copied
Double-Sided on Recycled Paper 52.204-7    Jul 2013    System for Award
Management 52.204-10    Jul 2013    Reporting Executive Compensation and
First-Tier Subcontract Awards

 

 

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52.204-13    Jul 2013    System for Award Management Maintenance 52.209-6    Aug
2013    Protecting the government’s Interests When Subcontracting With
Contractors Debarred, Suspended, or Proposed for Debarment 52.209-9    Jul 2013
   Updates of Publicly Available Information Regarding Responsibility Matters
52.209-10    Dec 2014    Prohibition on Contracting with Inverted Domestic
Corporations 52.210-1    Apr 2011    Market Research 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
Certified Cost or Pricing Data 52.215-12    Oct 2010    Subcontractor Certified
Cost or Pricing Data 52.215-15    Oct 2010    Pension Adjustments and Asset
Reversions 52.215-18    Jul 2005    Reversion or Adjustment of Plans for
Post-Retirement Benefits (PRB) other than Pensions 52.215-19    Oct 1997   
Notification of Ownership Changes 52.215-21    Oct 2010    Requirements for
Certified Cost or Pricing Data and Data Other Than Certified Cost or Pricing
Data – Modifications 52.215-23    Oct 2009    Limitations on Pass-Through
Charges 52.216-7    Jun 2013    Allowable Cost and Payment 52.216-8    Jun 2011
   Fixed Fee 52.217-8    Nov 1999    Option to Extend Services 52.219-8    Oct
2014    Utilization of Small Business Concerns 52.222-2    Jul 1990    Payment
for Overtime Premiums 52.222-3    Jun 2003    Convict Labor 52.222-21    Apr
2015    Prohibition of Segregated Facilities 52.222-26    Apr 2015    Equal
Opportunity 52.222-35    Jul 2014    Equal Opportunity for Veterans 52.222-36   
Jul 2014    Equal Opportunities for Workers with Disabilities 52.222-37    Jul
2014    Employment Reports on Veterans 52.222-40    Dec 2010    Notification of
Employee Rights Under the National Labor Relations Act 52.222-50    Mar 2015   
Combating Trafficking in Persons 52.222-54    Aug 2013    Employment Eligibility
Verification 52.223-6    May 2001    Drug-Free Workplace 52.223-18    Aug 2011
   Encouraging Contractor Policies to Ban Text Messaging While Driving

 

 

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52.224-1    April 1984    Privacy Act Notification 52.224-2    April 1984   
Privacy Act 52.225-13    Jun 2008    Restrictions on Certain Foreign Purchases
52.227-1    Dec 2007    Authorization and Consent, Alternate I 52.227-2    Dec
2007    Notice and Assistance Regarding Patent and Copyright Infringement
52.227-3    April 1984    Patent Indemnity 52.227-11    May 2014    Patent
Rights - Ownership by the Contractor (Note: In accordance with FAR 27.303(b)(2),
paragraph (e) is modified to include the requirements in FAR 27.303(b)(2)(i)
through (iv). The frequency of reporting in (i) is annual.) 52.227-14    May
2014    Rights in Data – General 52.227-14    May 2014    Rights in Data –
General, Alternate II 52.227-16    Jun 1987    Additional Data Requirements
52.232-9    Apr 1984    Limitation on Withholding of Payments 52.232-17    May
2014    Interest 52.232-20    Apr 1984    Limitation of Cost 52.232-23    May
2014    Assignment of Claims 52.232-25    Jun 2013    Prompt Payment Alternate I
(Feb 2002) 52.232-33    Jul 2013    Payment by Electronic Funds Transfer—System
for Award Management 52.233-1    May 2014    Disputes 52.233-3    Aug 1996   
Protest After Award, Alternate I (June 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 2014    Penalties for Unallowable Costs 2.242-4
   Jan 1997    Certification of Final Indirect Costs 52.242-13    Jul 1995   
Bankruptcy 52.243-2    Aug 1987    Changes - Cost Reimbursement, Alternate V
(Apr 1984) 52.243-6    Apr 1984    Change Order Accounting 52.244-2    Oct 2010
   Subcontracts, Alternate I (Jun 2007) 52.244-5    Dec 1996    Competition in
Subcontracting 52.244-6    Apr 2015    Subcontracts for Commercial Items

 

 

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52.245-1    Apr 2012    Government Property 52.245-9    Apr 2012    Use and
Charges 52.246-9    Apr 1984    Inspection of Research and Development (Short
Form) 52.246-23    Feb 1997    Limitation of Liability 52.246-25    Feb 1997   
Limitation of Liability – Services 52.247-63    Jun 2003    Preference for
U.S.-Flag Air Carriers 52.247-67    Feb 2006    Submission of Transportation
Documents for Audit 52.249-6    May 2004    Termination (Cost-Reimbursement)
52-249-14    Apr 1984    Excusable Delays 52.251-1    Apr 2012    Government
Supply Sources 52.253-1    Jan 1991    Computer Generated Forms

 

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

 

HHSAR
CLAUSE NO.

  

DATE

  

TITLE

352.201-70    Jan 2006    Paperwork Reduction Act 352.202-1    Jan 2006   
Definitions, with Alternate paragraph (h) 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 352.233-71    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

 

 

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352.270-4    Jan 2006    Protection of Human Subjects

ARTICLE I.2. ADDITIONAL CONTRACT CLAUSES

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

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

ARTICLE I.3. ADDITIONAL FAR CLAUSES INCLUDED IN FULL TEXT

FAR 52.217-9 Option to Extend the Term of the Contract

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 15 days of the date the contract expires; provided that the
government gives the Contractor a preliminary written notice of its intent to
extend at least 60 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 base contract and the
exercise of any options under this clause, shall not exceed sixty (60) months.

FAR 52.219-1 Small Business Program Representations

SMALL BUSINESS PROGRAM REPRESENTATIONS (OCT 2014)

(b) (1) The North American Industry Classification System (NAICS) code for this
acquisition is 541711.

(2) The small business size standard is 500 employees.

(3) The small business size standard for a concern which submits an offer in its
own name, other than on a construction or service contract, but which proposes
to furnish a product which it did not itself manufacture, is 500 employees.

(c) Representations.

(1) The offeror represents as part of its offer that it [X] is, [    ] is not a
small business concern.

(2) The offeror represents as part of its offer that it [    ] is, [X] is not, a
small disadvantaged business concern as defined in 13 CFR 124.1002.

(3) The offeror represents as part of its offer that it [    ] is, [X] is not a
woman-owned small business concern.

FAR 52.219-28, Post-Award Small Business Program Representation

 

 

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POST-AWARD SMALL BUSINESS PROGRAM REPRESENTATION (JUL 2013)

(a) Definitions. As used in this clause—

Long-term contract means a contract of more than five years in duration,
including options. However, the term does not include contracts that exceed five
years in duration because the period of performance has been extended for a
cumulative period not to exceed six months under the clause at 52.217-8, Option
to Extend Services, or other appropriate authority.

Small business concern means a concern, including its affiliates, which 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

 

 

HHSO100201500011C

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

 

Page 55

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representations in the Online Representations and Certifications Application and
its data in the Central Contractor Registration, as necessary, to ensure that
they reflect the Contractor’s current status. The Contractor shall notify the
contracting office in writing within the timeframes specified in paragraph
(b) of this clause that the data have been validated or updated, and provide the
date of the validation or update.

(f) If the Contractor represented that it was other than a small business
concern prior to award of this contract, the Contractor may, but is not required
to, take the actions required by paragraphs (e) or (g) of this clause.

(g) If the Contractor does not have representations and certifications in ORCA,
or does not have a representation in ORCA for the NAICS code applicable to this
contract, the Contractor is required to complete the following representation
and submit it to the contracting office, along with the contract number and the
date on which the representation was completed:

The Contractor represents that it [X] is, [    ] is not a small business concern
under NAICS Code 541711 assigned to contract number HHSO100201500011C.

FAR 52.232-40, Providing Accelerated Payment to Small Business Subcontractors

PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS (DEC 2013)

(a) Upon receipt of accelerated payments from the government, the contractor
shall make accelerated payments to its small business subcontractors under this
contract, to the maximum extent practicable and prior to when such payment is
otherwise required under the applicable contract or subcontract after receipt of
a proper invoice and all other required documentation from the small business
subcontractor.

(b) The acceleration of payments under this clause does not provide any new
rights under the Prompt Payment Act.

(c) Include the substance of this clause, including this paragraph (c), in all
subcontracts with small business concerns, including subcontracts with small
business concerns for the acquisition of commercial items.

 

 

HHSO100201500011C

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

 

Page 56

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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, dated April 17, 2015 (21 pages).

 

  2. Milestones and Deliverables Chart (3 pages)

 

  3. Reserved

 

  4. Invoice/Financing Request Instructions and Contract Financial Reporting
Instructions for Cost-Reimbursement Type Contracts (5 pages).

 

  5. Financial Report of Individual Project/Contract (1 page)

 

  6. Instructions for Completing Financial Report of Individual Project/Contract
(3 pages)

 

  7. 7 Principles of Earned Value Management Tier 2 System Implementation Intent
Guide (26 pages)

 

 

HHSO100201500011C

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

 

Page 57

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PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS AND CERTIFICATIONS

The following documents are incorporated by reference in this contract:

 

  1. Annual Representations and Certifications completed and located at the
System for Award Management website (SAM.gov).

2. Animal Welfare Assurance – The subcontractors, general procedures for animal
care and housing will meet current Association for Assessment and Accreditation
of Laboratory Animal Care International (AAALAC) recommendations, current
requirements stated in the current “Guide for Care and Use of Laboratory
Animals”, current requirements as stated by the U.S. Department of Agriculture
through the Animal Welfare Act, as amended, and will conform to the testing
facility SOPs.

End of Contract No: HHSO100201500011C

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

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

ATTACHMENT 1

PX563L/RPA563 ADVANCED DEVELOPMENT

Topic Area of Interest No. 1,

Contractual Statement of Work

[***]

ATTACHMENT 2

[***]

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

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

ATTACHMENT 3

Reserved

ATTACHMENT 4

INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORTING

INSTRUCTIONS FOR COST-REIMBURSEMENT TYPE 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 B of the Contract.

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

Cost Incurrence Period: Costs incurred must be within the contract performance
period or covered by previously established pre contract cost provisions.

Billing of Costs Incurred: If billed costs include (1) costs of a prior billing
period, but not previously billed, or (2) costs incurred during the contract
period and claimed after the contract period has expired, the Contractor shall
cite the amount(s) and month(s) in which it incurred such costs.

Contractor’s Fiscal Year: Payment requests shall be prepared in such a manner
that the Government can identify costs claimed with the Contractor’s fiscal
year.

Currency: All contracts are expressed in United States dollars. When the
Government pays in a currency other than United States dollars, billings shall
be expressed, and payment by the Government shall be made, in that other
currency at amounts coincident with actual costs incurred. Currency fluctuations
may not be a basis of gain or loss to the Contractor.

Notwithstanding the above, the total of all invoices paid under this contract
may not exceed the United States dollars authorized.

Costs Requiring Prior Approval: Costs requiring the Contracting Officer’s
approval, which are not set forth in an Advance Understanding in the contract,
shall be identified and reference the Contracting Officer’s Authorization (COA)
Number. In addition, the Contractor shall show any cost set forth in an Advance
Understanding as a separate line item on the payment request.

Invoice/Financing Request Identification: Each payment request shall be
identified as either:

 

(a) Interim Invoice/Contract Financing Request: These are interim payment
requests submitted during the contract performance period.

 

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

 

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

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

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

Preparation and Itemization of the Invoice/Financing Request: The Contractor
shall furnish the information set forth in the instructions below. The
instructions are keyed to the entries on the Sample Invoice/Financing Request.

 

(a) Designated Billing Office Name and Address: Enter the designated billing
office name and address, as identified in the Invoice Submission Instructions in
Section B and F of the Contract Schedule.

 

(b) Contractor’s Name, Address, Point of Contact, VIN, and DUNS or DUNS+4
Number: Show the Contractor’s 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.

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

  (1)     

 

  (2) Direct Labor: Include salaries and wages paid (or accrued) for direct
performance of the contract.

For Level of Effort contracts only, the Contractor shall provide the following
information on a separate sheet of paper attached to the payment request:

 

  •   hours or percentage of effort and cost by labor category (as specified in
the Level of Effort Article in Section F of the contract) for the current
billing period, and

 

  •   hours or percentage of effort and cost by labor category from contract
inception through the current billing period. (NOTE: The Contracting Officer may
require the Contractor to provide additional breakdown for direct labor, such as
position title, employee name, and salary or hourly rate.)

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

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

  (3) 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.

 

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

On a separate sheet of paper attached to the payment request, list each item for
which reimbursement is requested. An asterisk (*) shall precede the item if the
equipment is below the $1,000 approval level. Include reference to the following
(as applicable):

 

  •   item number for the specific piece of equipment listed in the Property
Schedule, and

 

  •   COA number, if the equipment is not covered by the Property Schedule.

The Contracting Officer may require the Contractor to provide further
itemization of property having specific limitations set forth in the contract.

 

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

 

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

 

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

 

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

 

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

 

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

 

(p) Cost of Money (COM): Cite the COM factor and base in effect during the time
the cost was incurred and for which reimbursement is claimed.

 

(q) Indirect Costs: Identify the indirect cost base (IDC), indirect cost rate,
and amount billed for each indirect cost category.

 

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

 

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

 

(t) Adjustments: Include amounts conceded by the Contractor, outstanding
suspensions, and/or disapprovals subject to appeal.

 

(u) Grand Totals

 

(v) Certification of Salary Rate Limitation: If required by the contract (see
Invoice Submission Instructions in Section G of the Contract Schedule), the
Contractor shall include the following certification at the bottom of the
payment request:

“I hereby certify that the salaries billed in this payment request are in
compliance with the Salary Rate Limitation Provisions in Section H of the
contract.”

 

(w) Signature

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

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

The Contracting Officer may require the Contractor to submit detailed support
for costs claimed on one or more interim payment requests.

FINANCIAL REPORTING INSTRUCTIONS:

These instructions are keyed to the Columns on the sample invoice/financing
request.

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

Column B - Cumulative Percentage of Effort/Hrs. - Negotiated: Enter the
percentage of effort or number of hours agreed to for each employee or labor
category listed in Column A.

Column C - Cumulative Percentage of Effort/Hrs. - Actual: Enter the percentage
of effort or number of hours worked by each employee or labor category listed in
Column A.

Column D - Amount Billed - Current: Enter amounts billed during the current
period.

Column E - Amount Billed - Cumulative: Enter the cumulative amounts to date.

Column F - Cost at Completion: Enter data only when the Contractor estimates
that a particular expenditure category will vary from the amount negotiated.
Realistic estimates are essential.

Column G - Contract Amount: Enter the costs agreed to for all expenditure
categories listed in Column A.

Column H - Variance (Over or Under): Show the difference between the estimated
costs at completion (Column F) and negotiated costs (Column G) when entries have
been made in Column F. This column need not be filled in when Column F is blank.
When a line item varies by plus or minus 10 percent, i.e., the percentage
arrived at by dividing Column F by Column G, an explanation of the variance
should be submitted. In the case of an overrun (net negative variance), this
submission shall not be deemed as notice under the Limitation of Cost (Funds)
Clause of the contract.

Modifications: Any modification in the amount negotiated for an item since the
preceding report should be listed in the appropriate cost category.

Expenditures Not Negotiated: An expenditure for an item for which no amount was
negotiated (e.g., at the discretion of the Contractor in performance of its
contract) should be listed in the appropriate cost category and all columns
filled in, except for

G. Column H will of course show a 100 percent variance and will be explained
along with those identified under H above.

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

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

SAMPLE INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORT

 

(a)    Designated Billing Office Name and Address:   

DHHS/OS/ASPR/BARDA

  

Attn: Contracting Officer

  

330 Independence Ave., S.W.

  

Room G644

  

Washington, D.C. 20201

(b)    Contractor’s Name, Address, Point of Contact, VIN, and DUNS or DUNS+4
Number:    ABC CORPORATION    100 Main Street    Anywhere, USA Zip Code   

Name, Title, Phone Number, and E-mail Address of person to notify in the event
of an improper invoice or, in the case of payment by method other than
Electronic Funds Transfer, to whom payment is to be sent.

  

VIN:

  

DUNS or DUNS+4:

(c)    Invoice/Financing Request No.: (d)    Date Invoice Prepared: (e)   
Contract No. and Order No. (if applicable):   (f)    Effective Date: (g)   
Total Estimated Cost of Contract/Order: (h)    Total Fixed-Fee (if applicable):
(i)    ¨ Two-Way Match:    x Three-Way Match: (j)    Office of Acquisitions: (k)
   Central Point of Distribution:

 

 

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

 

Expenditure Category*

A

   Cumulative Percentage of
Effort/Hrs.    Amount Billed    Cost at
Completion
F    Contract
Amount
G    Variance
H    Negotiated
B    Actual
C    (m)
Current
D    (n)
Cumulative
E         

(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

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

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

ATTACHMENT 5

 

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
Period    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                                    
                                                                                
                                                                                
                                                                                
                                                                                
                                                                       

ATTACHMENT 6

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

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

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

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.”

 

(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.

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

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

PREPARATION INSTRUCTIONS

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

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

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

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

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

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

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

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

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

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

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

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

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

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

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

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 3

System Implementation Intent Guide

01 October 2011

 

LOGO [g73222stamp_pg069.jpg]

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

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TABLE OF CONTENTS

 

OVERVIEW

     1   

EVM IMPLEMENTATION TIERS

     3   

SEVEN PRINCIPLES OF EVM

     4   

Principle 1: Plan all Work Scope

     4   

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

     4   

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

     5   

Principle 3b: Control Changes to the Baseline

     6   

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

     7   

Principle 5: Objectively Assess Accomplishments at the Work Performance Level

     7   

Principle 6a: Analyze Significant Variances From the Plan

     8   

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

     9   

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

     9   

APPENDICES

     10   

APPENDIX 1: Glossary of Terms

     10   

Appendix 2 Supplemental EVM Implementation Guideline

     20   

Appendix 3 Sample EVM Documents

     23   

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

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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.

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

 

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7 Principles of EVM Tier 2 System Implementation Intent Guide

 

  5. Objectively assess accomplishments at the work performance level.

 

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

 

  7. Use earned value information in the company’s management processes.

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

 

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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.

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

 

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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.

In a Tier 3 implementation it is not necessary to provide a WBS Dictionary or a
Work Authorization Document but it is important to develop a WBS and define a
scope of work for each level of the WBS at the reporting level (usually level 3
or 2).

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. Most of the
normal functions accomplished when scheduling will be required on a 7 Principles
Tier 3 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

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

 

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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.

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.

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

 

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It is recommended that management reserve and undistributed budget be utilized
in the budgeting process. Undistributed budget is budget that has not yet been
distributed to a control account 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.

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.

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

 

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

Some of the new acquisitions at BARDA will be required to be compliant with the
Cost Accounting Standards. For Tier 3 implementation contractors must utilize a
work order/job order/task code charge number structure that uniquely identifies
costs at the control account level, which may be as high as the reporting level
of the WBS. 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 achieved by recording the actual costs equal to the work
that was performed in the EVM system and on the CPR. If the subcontractor is a
cost plus contract its imperative the costs the prime reports is 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.

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

 

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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.

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 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.

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

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

 

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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 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.

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

 

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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.

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

 

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Baseline    (See Performance Measurement Baseline). Budget at Completion (BAC)
   The sum of all budgets (BCWS) allocated to the contract. Synonymous with the
term Performance Measurement Baseline. Budgeted Cost for Work Performed (BCWP)
   The sum of the budgets for completed Work Packages 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. 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

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

 

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   (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) and may also include milestone information. 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.

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

 

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

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

 

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   treatment as direct costs. (See overhead). Integrated Baseline Review (IBR)
  

An Integrated Baseline Review (IBR) also known as Performance Measurement
Baseline Review (PMBR) is 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

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

 

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   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. 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

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

 

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   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

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

 

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Time-Phased S/P/A Report    Provides the timphased budget, performance (earned
value) and actual costs at a specific level. It may be at 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. 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

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

 

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   identity of the CAM. It must be approved by Intermediate Manager, and be
agreed to by the Control Account Manager. Work Breakdown Structure (WBS)   

A product-oriented, family-tree composed of hardware, software, services, data
and facilities which results 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.

 

(1) 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.

 

(2) 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.

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

 

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

  

2. It is clearly distinguishable from all other work packages.

  

3. It is assignable to a single organizational element.

  

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

  

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

  

6. 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.

  

7. 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.

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

 

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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-$125K

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

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

 

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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.

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 monthly timephased S/P/A 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 $125K. For a cost
analyst it should be equal to or less than $110K. If a company is bringing in a
contractor to provide staff implementation the costs should be up to $125/hr for
a schedule analyst and $110/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.

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

 

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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
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”.

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

 

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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.

Sample WBS Scope Description

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

 

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LOGO [g73222stamp_pg094.jpg]

Sample Timephased S/P/A Report

 

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

 

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