[coverpage.jpg]

 
 

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

 

 
PART I -  THE SCHEDULE
 
SECTION B  - SUPPLIES OR SERVICES AND PRICES/COSTS
 
ARTICLE B.1.  BRIEF DESCRIPTION OF SUPPLIES OR SERVICES
 
The purpose of the contract is the development and FDA licensure of a
large-scale manufacturing process for BioThrax®.
 
ARTICLE B.2.   ESTIMATED COST AND FIXED FEE
 
a.  
The total estimated cost of the base period of performance contract is $[**].

 
b.  
The total fixed fee for the base period of performance contract is $[**].  The
fixed fee shall be paid in accordance with and subject to the withholding
provisions of the clauses ALLOWABLE COST AND PAYMENT and FIXED FEE referenced in
the General Clause Listing in Part II, ARTICLE I.1 of this contract.  Payment of
fixed fee shall not be made in less than monthly increments.

 
c.  
The total amount of the contract, represented by the sum of the total estimated
cost plus fixed fee is $54,586,376.

 
d.  
It is estimated that the amount currently allotted will cover performance of the
contract through July 18, 2012.

 
CONTRACT LINE ITEM NUMBERS (CLINs)
 
BASE PERIOD
 
CLIN
PERIOD
OF PERFORM.
SUPPLIES/SERVICES
TOTAL
ESTIMATED
COST
FIXED FEE
TOTAL ESTIMATED
COST PLUS
FIXED
 
0001
7/19/2010-7/18/2012
[**]
[**]
[**]
$54,586,376

ARTICLE B.3. OPTION PRICES
 
a.  
Unless the Government exercises its option pursuant to the option clause
referenced in ARTICLE I.1., the contract consists only of the Base Period
specified in the Statement of Work as defined in SECTIONS C and F, for the price
set forth in ARTICLE B.2. of the contract.

 
b.  
Pursuant to H.  13.  EXERCISE OF OPTIONS and Option for Increased Quantity (FAR
Clause 52.217-7) the Government may, by unilateral contract modification,
require the Contractor to perform the Option(s) specified in the Statement of
Work as defined in SECTIONS C and F of this contract.  If the Government
exercises this/these option(s), notice must be given before the expiration date
of the contract.  Specific information regarding the time frame for this notice
is set forth in the OPTION CLAUSE Article in SECTION H of this contract.  The
estimated cost of the contract will be increased as set forth below:

 
CONTRACT OPTION PERIODS
 
Option Period 1 (CLIN 0003)
Option Period 2 (CLIN 0004)
Option Period 3 (CLIN 0005)
Option to Conduct Feasibility Studies for Long-Term Storage of Frozen Bulk Drug
Substance Year 1 (CLIN 0006)
Option to Conduct Feasibility Studies for Long-Term Storage of Frozen Bulk Drug
Substance Year 2 (CLIN 0007)
Option to Conduct Feasibility Studies for Long-Term Storage of Frozen Bulk Drug
Substance Year 3 (CLIN 0008)

OPTION
CLIN
PERIOD
OF PERFORM.
SUPPLIES/SERVICES
TOTAL
ESTIMATED
COST
FIXED FEE
TOTAL ESTIMATED
COST PLUS
FIXED
 
0002
 
RESERVED.
 
     
0003
7/19/2012- 7/18/2013
[**]
[**]
[**]
$25,981,420
0004
7/19/2013-7/18/2014
[**]
[**]
[**]
$13,461,557
0005
7/19/2014-7/18/2015
[**]
[**]
[**]
$10,847,991
0006
10/1/2011- 9/30/2012
[**]
[**]
[**]
$1,302,527
0007
10/1/2012- 9/30/2013
[**]
[**]
[**]
$622,257
0008
10/1/2013- 9/30/2014
[**]
[**]
[**]
$62,219

ARTICLE B.4. PROVISIONS APPLICABLE TO DIRECT COSTS
 
a.  
Items Unallowable

 
Notwithstanding the clause, ALLOWABLE COST AND PAYMENT, incorporated in the
contract, unless authorized in writing by the Contracting Officer, the costs of
the following items or activities shall be unallowable as direct costs:
 
1. Acquisition, by purchase or lease, of any interest in real property;
 
2. Special rearrangement or alteration of facilities;
 
3. Purchase or lease of any item of general purpose office furniture or office
equipment regardless of dollar 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;
 
5. Foreign travel - See subparagraph b below;
 
6. Consultant costs;
 
7. Subcontracts;
 
8. Research patient care costs − See Attachment 1;
 
9. Accountable Government property (defined as both real and personal property
with an acquisition cost of $1,000 or more and a life expectancy of more than
two years) and “sensitive items” (defined and listed in the Contractor’s Guide
for Control of Government Property, see Article G.10), regardless of acquisition
value.
 
10. Printing Costs (as defined in the Government Printing and Binding
Regulations).
 
11. Light Refreshment and Meal Expenditures.  Requests to use contract funds to
provide light refreshments and/or meals to either federal or nonfederal
employees must be submitted to the Project Officer, with a copy to the
Contracting Officer, at least six (6) weeks in advance of the event.  The
request shall contain the following information:  (a) name, date, and location
of the event at which the light refreshments and/or meals will be provided; (b)
a brief description of the purpose of the event; (c) a cost breakdown of the
estimated light refreshment and/or meal costs; and (d) the number of nonfederal
and federal attendees receiving light refreshments and/or meals.  It is unlikely
that BARDA will approve these requests since circumstances are very limited
under which appropriated funds can be used for these costs.
 
b.  
Travel Costs

 
1. Domestic Travel
 
a.  
Total expenditures for domestic travel (transportation, lodging, subsistence,
and incidental expenses) incurred in direct performance of this contract shall
not exceed $30,000 during the base period (7/19/2010-7/18/2012) without the
prior written approval of the Contracting Officer.

 
b.  
Subject to the annual dollar limitation specified under B.4.b.l.a. above the
Contractor shall invoice and be reimbursed for all travel costs in accordance
with FAR Subpart 31.2 contracts with Commercial Organizations and FAR §
31.205-46 Travel Costs

 
2. Foreign Travel
 
Requests for foreign travel must be submitted at least six weeks in advance and
shall contain the following:  (a) meeting(s) and place(s) to be visited, with
costs and dates; (b) name(s) and title(s) of Contractor personnel to travel and
their functions in the contract project; (c) contract purposes to be served by
the travel; (d) how travel of Contractor personnel will benefit and contribute
to accomplishing the contract project, or will otherwise justify the expenditure
of AMCG contract funds; (e) how such advantages justify the costs for travel and
absence from the project of more than one person if such are suggested; and (f)
what additional functions may be performed by the travelers to accomplish other
purposes of the contract and thus further benefit the project.
 
ARTICLE B.5.  ADVANCE UNDERSTANDINGS
 
a.  
Man-in-Plant

 
With 7 days advance notice to the Contractor via in writing from the Contracting
Officer, the Government may place a man-in-plant in the Contractor’s facility
and shall be subject to the Contractor’s polices and procedures as well as
security and facility access procedures at all times while in the Contractor’s
facility.  The man-in-plant is restricted to observing, verifying, and surveying
the Contractor’s performance under the contract.
 
b.  
Security Plan

 
The Contractor agrees to provide an updated Security Plan, if requested by the
Contracting Officer, and within fifteen (15) working days after receipt of the
request.
 
The Contractor agrees to provide data generated from this contract to the
Contracting Officer upon request either in the form of an email attachment or
via delivery to a secured Government eRoom.
 
c.  
Subcontracts and Consultants

 
Award of any subcontract or consulting agreement shall not proceed without the
prior written consent of the Contracting Officer upon review of the supporting
documentation required by FAR Clause 52.244-2, Subcontracts.  After receiving
written consent of the subcontract by the Contracting Officer, a copy of the
signed, executed subcontract shall be provided to the Contracting Officer.
 
d.  
Site Visits and Inspections

 
At the discretion of the U.S. Government and independent of activities conducted
by the Contractor, within ten (10) business days notice to the Contractor via
written notification from the Contracting Officer, the U.S. Government reserves
the right to conduct site visits and inspections on an as needed basis,
including collection of samples limited to [**] vials of Final Drug Product and
samples of key intermediates held at the Contractor’s or Subcontractor’s site,
provided that the Government’s collection of such samples should not frustrate
the Contractor’s ability to perform under the contract.
 
e.  
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, 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
amount.  Cite COA, if appropriate.  List separately, domestic travel, general
scientific meeting travel, and foreign travel.

 
f.  
Consultant Fees - Identify individuals and amounts.

 
g.  
Subcontracts - Attach sub-Contractor invoice(s).

 
h.  
Equipment - Cite authorization and amount.

 
i.  
G&A - Cite rate and amount.

 
j.  
Total Cost

 
k.  
Fixed Fee

 
l.  
Total CPFF

 
Monthly invoices must include the cumulative total expenses to date, adjusted
(as applicable) to show any amounts suspended by the Government.
 
f.  
Confidential Treatment of Sensitive Information

 
The Contractor shall guarantee strict confidentiality of any information/data of
a sensitive nature that is generated by the Government during the performance of
the contract.  The Government has determined that the information/data that the
Contractor will be provided during the performance of the contract is of a
sensitive nature.
 
Disclosure of information/data that is sensitive in nature, in whole or in part,
by the Contractor can only be made after the Contractor receives prior written
approval from the Contracting Officer.  Whenever the Contractor is uncertain
with regard to the proper handling of information/data under the contract, the
Contractor shall obtain a written determination from the Contracting
Officer.  (See also HHSAR clause 352.224-70).
 
Notwithstanding the foregoing, such information/data shall not be deemed of a
sensitive nature with respect to the Contractor for purposes of this contract if
such information/data:  (a) was already known to the Contractor; (b) was
generally available or known, or was otherwise part of the public domain, at the
time of its disclosure to the Contractor; (c) became generally available or
known, or otherwise became part of the public domain, after its disclosure to,
or, with respect to the information/data by, the Contractor through no fault of
the Contractor; (d) was disclosed to the Contractor, other than under an
obligation of confidentiality or non-use, by a third party who had no obligation
to the Government that controls such information/data not to disclose such
information/data to others; or (e) was independently discovered or developed by
the Contractor, as evidenced by its written records, without the use of
information/data belonging to the Government.
 
Contractor may disclose information/data of a sensitive nature provided by the
Government to the extent that such disclosure is:  (a) made in response to a
valid order of a court of competent jurisdiction or other supra-national,
federal, national, regional, state, provincial or local governmental or
regulatory body of competent jurisdiction; provided, however, that the
Contractor shall first have given notice to the Government and give the
Government a reasonable opportunity to quash such order and to obtain a
protective order requiring that the information/data of a sensitive nature that
is the subject of such order be held in confidence by such court or agency or,
if disclosed, be used only for the purposes for which the order was issued; and
provided further that if a disclosure order is not quashed or a protective order
is not obtained, the information/data disclosed in response to such court or
governmental order shall be limited to that information which is legally
required to be disclosed in response to such court or governmental order; (b)
otherwise required by law, in the opinion of legal counsel to the Contractor as
expressed in an opinion letter in form and substance reasonably satisfactory to
the Government, which shall be provided to the Government at least two (2)
business days prior to the Contractor’s disclosure of the information/data; or
(c) made by the Contractor to the Regulatory Authorities as required in
connection with any filing, application or request for Regulatory Approval;
provided, however, that reasonable measures shall be taken to assure
confidential treatment of such information/data.
 
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 5 May 2010 set forth in SECTION J-List of Attachments,
attached hereto and made a part of the contract.
 
ARTICLE C.2.  REPORTING REQUIREMENTS
 
Technical Reports
 
In addition to those reports required by the other terms of this contract, the
Contractor shall prepare and submit the following reports in the manner stated
below and in accordance with the DELIVERIES Article in SECTION F of this
contract and in SECTION J-List of Attachments, attached hereto and made a part
of the contract.
 
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;
 
SECTION I-An introduction covering the purpose and scope of the contract effort;
 
SECTION II-PROGRESS
 
SECTION II Part A:  OVERALL PROGRESS-A description of overall progress;
 
SECTION II Part B:  MANAGEMENT AND ADMINISTRATIVE UPDATE-A description of all
meetings, conference calls, etc. that have taken place during the reporting
period.  Include progress on administration and management issues (e.g.
evaluating, and managing subcontractor performance);
 
SECTION II Part C:  TECHNICAL PROGRESS-For each activity, document the results
of work completed and cost incurred during the period covered in relation to
proposed progress, effort and budget.  The report shall be in sufficient detail
to explain comprehensively the results achieved.  The description shall include
pertinent data and/or graphs in sufficient detail to explain any significant
results achieved and preliminary conclusions resulting from analysis and
scientific evaluation of data accumulated to date under the contract.  The
report shall include a description of problems encountered and proposed
corrective action; differences between planned and actual progress, why the
differences have occurred and what corrective actions are planned; preliminary
conclusions resulting from analysis and scientific evaluation of data
accumulated to date under the project;
 
SECTION II Part D; PROPOSED WORK-A summary of work proposed for the next
reporting period and preprints/reprints of papers and abstracts.
 
A Monthly Progress Report will not be required in the same month that the
Quarterly or Annual Technical Progress Report is submitted.
 
2.  
Quarterly Progress Report

 
This report shall include a description of the activities during the reporting
period, and the activities planned for the ensuing reporting period.  The first
reporting period consists of the first full quarter of performance plus any
fractional part of the initial quarter.  Thereafter, the reporting period shall
consist of each calendar quarter.
 
The Contractor shall submit a Quarterly Progress Report on or before the 15th
calendar day following the last day of each reporting period and shall include
the following:
 
A cover page that includes the contract number and title; the type of report and
period that it covers; the Contractor’s name, address, telephone number, fax
number, and e-mail address; and the date of submission;
 
SECTION I-An introduction covering the purpose and scope of the contract effort;
 
SECTION II-PROGRESS
 
SECTION II Part A:  OVERALL PROGRESS-A description of overall progress;
 
SECTION II Part B:  MANAGEMENT AND ADMINISTRATIVE UPDATE-A description of all
meetings, conference calls, etc. that have taken place during the reporting
period.  Include progress on administration and management issues (e.g.
evaluating, and managing subcontractor performance);
 
SECTION II Part C:  TECHNICAL PROGRESS-For each activity, document the results
of work completed and cost incurred during the period covered in relation to
proposed progress, effort and budget.  The report shall be in sufficient detail
to explain comprehensively the results achieved.  The description shall include
pertinent data and/or graphs in sufficient detail to explain any significant
results achieved and preliminary conclusions resulting from analysis and
scientific evaluation of data accumulated to date under the contract.  The
report shall include a description of problems encountered and proposed
corrective action; differences between planned and actual progress, why the
differences have occurred and what corrective actions are planned; preliminary
conclusions resulting from analysis and scientific evaluation of data
accumulated to date under the project;
 
SECTION II Part D; PROPOSED WORK- A summary of work proposed for the next
reporting period; and preprints/reprints of papers, abstracts and a current
GANTT chart.  A Quarterly Progress Report will not be required in the same month
that the Annual Progress Report is submitted.
 
3.  
Annual Progress Report

 
This report shall include a summation of the results of the entire contract work
for the period covered.  An Annual Technical Progress Report will not be
required for the period when the Final Technical Progress Report is
due.  Monthly and Quarterly Progress Reports shall not be submitted in the same
month when an Annual Progress Report is due.
 
The first Annual Progress Report shall be due on or before the 15th Calendar day
following the last day of the reporting period.  Each Annual Progress Report
shall include:
 
a)           A Cover page that includes the contract number and title; the type
of report and period that it covers; the Contractor’s name, address, telephone
number, fax number, and email address; and the date of submission;
 
b)           SECTION I:  EXECUTIVE SUMMARY - A brief overview of the work
completed, and the major accomplishments achieved during the reporting period;
 
c)           SECTION II:  PROGRESS
 
i)           SECTION II Part A:  OVERALL PROGRESS-A description of overall
progress;
 
ii)           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; regulatory compliance
audits);
 
iii)           SECTION II Part C:  TECHNICAL PROGRESS-A detailed description of
the work performed structured to follow the activities and decision gates
outlined in the approved Strategic Staged Product Development Plan.  The Report
should include a description of any problems (technical or financial) that
occurred or were identified during the reporting period, and how these problems
were resolved;
 
iv)           SECTION II Part D; PROPOSED WORK-A summary of work proposed for
the next year period.
 
a)           Copies of manuscripts (published and unpublished), abstracts, and
any protocols or methods developed specifically under the contract during the
reporting period; and
 
b)           A summary of any inventions developed during the course of the
contract.  (See also FAR Clause 52.227-11)
 
4.  
Draft Final Technical Progress Report and Final Technical Progress Report

 
These reports are to include a summation of the work performed and results
obtained for the entire contract period of performance.  This report shall be in
sufficient detail to describe comprehensively the results achieved.  The Draft
Final Report and Final Report shall be submitted in accordance with the
DELIVERIES Article in SECTION F of the contract.  An Annual Technical Progress
Report will not be required for the period when the Final Technical Progress
Report is due.  The Draft Final Technical Progress Report shall be submitted one
hundred twenty (120) calendar days before completion date of the contract and
the Final Technical Progress Report shall be submitted on or before the
completion date of the contract.  The report shall conform to the following
format:
 
(a)           Cover page to include the contract number, contract title,
performance period covered, Contractor’s name and address, telephone number, fax
number, email address and submission date;
 
 (b)           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.
 
 (c)           SECTION II: RESULTS-A detailed description of the work performed,
the results obtained, and the impact of the results on the scientific and/or
public health community, including a listing of all manuscripts (published and
in preparation) and abstracts presented during the entire period of performance,
and a summary of all inventions.
 
Draft Final Technical Progress Report:  The Contractor is required to submit the
Draft Final Technical Progress Report to the Contracting Officer’s Technical
Representative and Contracting Officer.  This report is due 120 calendar days
before the completion date of the contract.  The Contracting Officer’s Technical
Representative and Contracting Officer will review the Draft Final Technical
Progress Report and provide the Contractor with comments within 45 calendar days
after receipt.
 
Final Technical Progress Report:  The Contractor will deliver the final version
of the Final Technical Progress Report on or before the completion date of the
contract.  The final version shall include or address the Contracting Officer’s
Technical Representative comments and Contracting Officer comments on the draft
report.
 
5.  
Summary of Salient Results

 
The Contractor shall submit, with the Final Technical Progress Report, a summary
(not to exceed 200 words) of salient results achieved during the performance of
the contract.
 
6.  
Other Technical Progress Reports

 
 a.           Draft Report for Clinical and Non-Clinical Studies and Final
Report for Clinical and Non-Clinical Studies
 
· The non-clinical and clinical trial reports shall follow the format of
International Conference on Harmonization document ICH E3 “Guidelines on
Structure and Content of Clinical Study Reports”
(http://www.pharmacontract.ch/support/su_ich_liste.htm).
 
· Draft Final Report for Clinical and Non-Clinical Studies will be submitted to
the Contracting Officer’s Technical Representative and Contracting Officer (CO)
for review and comment no later than 15 working days after completion of
analysis of study data.
 
· The Contracting Officer shall provide written comments within 30 working days
after the submission of the Draft Final Report for Clinical and Non-Clinical
Studies.
 
· The comprehensive Final Report for Clinical and Non-Clinical Studies will be
submitted to the Contracting Officer and the Contracting Officer’s Technical
Representative within 30 calendar days after receiving comments on the Draft
Final Report for Clinical and Non-Clinical Studies from the Contracting
Officer.  The final version shall include or address the Contracting Officer’s
Technical Representative comments and Contracting Officer comments on the draft
report
 
b.           Audit Reports
 
Within thirty (30) calendar days of an audit related to conformance to FDA
regulations and guidance, including adherence to GLP, GMP, or GCP guidelines, as
it relates to performance under this contract where the results will adversely
impact contract performance, the Contractor shall provide the Contracting
Officer’s Technical Representative and the Contracting Officer with copies of
the audit report and a plan for addressing areas of nonconformance to FDA
regulations and guidance for GLP, GMP or GCP guidelines as identified in the
final audit report.
 
c.           Clinical Trial Protocols
 
BARDA has a responsibility to ensure that mechanisms and procedures are in place
to protect the safety of participants in BARDA-funded clinical
trials.  Therefore, as described in the NIAID Clinical Terms of Award
(http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf), the Contractor shall develop a
protocol for each clinical trial and submit all protocols and protocol
amendments for approval by the BARDA Contracting Officer’s Technical
Representative.  Important information regarding performing human subjects
research is available at
http://www3.nia.id.nih.gov/healthscience/clinicalstudies/.
 
Any updates to technical reports are to be addressed in the Monthly, Quarterly
and Annual Progress Reports.  The Contractor shall advise the Contracting
Officer’s Technical Representative or designee in writing and via electronic
communication in a timely manner of any issues potentially affecting contract
performance.
 
7.  
Other Reports/Deliverables

 
a.           Copies of FDA Correspondence and Meeting Summaries
 
1.           For any formal meeting with the FDA, the Contractor shall forward
initial draft minutes and subsequently final meeting minutes within thirty (30)
calendar days of receipt from the FDA to the BARDA Contracting Officer’s
Technical Representative.
 
2.           The Contractor shall forward the final draft minutes of any
informal meeting with the FDA to BARDA.
 
3.           The Contractor shall forward the dates and times of any meeting
with the FDA to BARDA at least 30 days prior to the meeting and make
arrangements for appropriate BARDA staff to attend FDA meetings.
 
4.           The Contractor shall provide BARDA the opportunity to review and
comment upon any documents to be submitted to the FDA.  The Contractor shall
provide BARDA with five (5) business days in which to review and provide
comments back to the Contractor.
 
b.           Technology Transfer
 
Animal Models and other technology packages developed under the contract that
include complete protocols and critical reagents for animal models developed
and/or improved with contract funding must be submitted at the request of the
BARDA Contracting Officer’s Technical Representative.  See FAR clause 52.227-11
(Patent Rights-Ownership by the Contractor).
 
c.           Institutional Biosafety Approval
 
The Contractor shall provide documentation of materials submitted for
Institutional Biosafety Committee Review and documentation of approval of
experiments at the request of the BARDA Contracting Officer’s Technical
Representative.
 
d.           Data
 
The Contractor shall provide raw data or specific analysis of data generated
with contract funding at the request of the BARDA Contracting Officer’s
Technical Representative.  See FAR clause 52.227-14 (Rights in Data-General).
 
e.           Meeting Minutes
 
The Contractor shall provide an electronic copy of conference call meeting
minutes/summaries to the BARDA Contracting Officer’s Technical Representative
and Contracting Officer within seven (7) calendar days after the conference call
is held.
 
f.           Audits/Site Visits
 
BARDA/AMCG Audits
 
The United States Government (USG) reserves the right to conduct an audit of the
Contractor with five (5) business days notice.  The USG reserves the right to
accompany the Contractor on routine and for-cause site-visits/audits of
subcontractors.  At the discretion of the USG and independent of testing
conducted by the Contractor, BARDA reserves the right to conduct site
visits/audits.
 
ARTICLE C.3. SUBJECT INVENTION REPORTING REQUIREMENT
 
All reports and documentation required by FAR Clause 52.227-11, including, but
not limited to, the invention disclosure report, the confirmatory license, and
the Government support certification, shall be directed to the Extramural
Inventions and Technology Resources Branch, OPERA, NIH, 6705 Rockledge Drive,
Room 2207, MSC 7987, Bethesda, Maryland 20892-7987 (Telephone:
301-435-1986).  In addition, one copy of an annual utilization report, and a
copy of the final invention statement, shall be submitted to the Contracting
Officer.  The final invention statement (see FAR 27.303 (b)(2)(ii)) shall be
submitted to the Contracting Officer on the expiration date of the
contract.  See also FAR clause 52.227-11 (Patent Rights-Ownership by the
Contractor).
 
Reports and documentation submitted to the Contracting Officer shall be sent to
the following address:
 
Contracting Officer
Ethan J. Mueller
Office of Acquisitions Management, Contracts, and Grants (AMCG)
330 Independence Avenue, S.W.
Room G640
Washington, D.C.  20201
 
If no invention is disclosed or no activity has occurred on a previously
disclosed invention during the applicable reporting period, a negative report
shall be submitted to the Contracting Officer at the address listed above.
 
To assist contractors in complying with invention reporting requirements of the
clause, “Interagency Edison,” an electronic invention reporting system has been
developed.  Use of Interagency Edison is encouraged as it streamlines the
reporting process and greatly reduces paperwork.  Access to the system is
through a secure interactive Web site to ensure that all information submitted
is protected.  Interagency Edison and information relating to the capabilities
of the system can be obtained from the Web ( http://www.iedisop.gov ), or by
contacting the Extramural Inventions and Technology Resources Branch, OPERA,
NIH.
 
ARTICLE C.4. TWICE MONTHLY CONFERENCE CALLS
 
A conference call between the Contracting Officer’s Technical Representative and
the principal investigator shall occur bi-monthly or as directed by the
Contracting Officer’s Technical Representative.  During this call the principal
investigator will discuss the activities during the reporting period, any
problems that have arisen and the activities planned for the ensuing reporting
period.  The first reporting period consists of the first full month of
performance plus any fractional part of the initial month.  Thereafter, the
reporting period shall consist of each calendar month.  The principal
investigator may choose to include other key personnel on the conference call to
give detailed updates on specific projects or this may be requested by the
Contracting Officer’s Technical Representative.
 
ARTICLE C.5. PROJECT MEETINGS
 
The Contractor shall participate in Project Meetings to coordinate the
performance of the contract, as requested by the Contracting Officer’s Technical
Representative.  These meetings may include face-to-face meetings with
BARDA/AMCG in Washington, D.C.  and at work sites of the Contractor and its
subcontractors.  Such meetings may include, but are not limited to, meetings of
the Contractor (and subcontractors invited by the Contractor) to discuss study
designs, site visits to the Contractor’s and subcontractor’s facilities, and
meetings with the Contractor and HHS officials to discuss the technical,
regulatory, and ethical aspects of the program.  The Contractor must provide
data, reports, and presentations to groups of outside experts and USG personnel
as required by the Contracting Officer’s Technical Representative in order to
facilitate review of contract activities.
 
SECTION D - PACKAGING, MARKING AND SHIPPING
 
All deliverables required under this contract shall be packaged, marked and
shipped in accordance with Government specifications.  At a minimum, all
deliverables shall be marked with the contract number and Contractor name.  The
Contractor shall guarantee that all required materials shall be delivered in
immediate usable and acceptable condition.
 
Report Deliverables
 
Unless otherwise specified by the Contracting Officer, delivery of reports to be
furnished to the Government under this contract (including invoices), shall be
addressed as follows:
 
Dr. Eric Espeland, Contracting Officer’s Technical Representative (COTR)
DHHS/OS/ASPR/BARDA
330 Independence Avenue, S.W.
Room 640G
Washington, D.C.  20201
E-mail:  Eric.Espeland@hhs.gov

Francine L. Hemphill, Contracting Specialist
DHHS/OS/ASPR/AMCG
330 Independence Avenue, S.W.
Room 640G
Washington, D.C.  2020
E-mail:  Francine.Hemphill@hhs.gov
 
SECTION E  - INSPECTION AND ACCEPTANCE
 
a.  
The Contracting Officer or the duly authorized representative will perform
inspection and acceptance of materials and services to be provided under this
contract.

 
b.  
For the purpose of this SECTION, the designated Contracting Officer’s Technical
Representative (COTR) is the authorized representative of the Contracting
Officer.

 
c.  
Inspection and acceptance will be performed at:

 
Biomedical Advanced Research and Development Authority
 
Office of the Assistant Secretary for Preparedness and Response
 
U.S. Department of Health and Human Services
 
330 Independence Avenue, S.W., Room G644
 
Washington, D.C. 20201
 
d.  
The contract incorporates the following clause by reference with the same force
and effect as if it were given in full text.  Upon request, the Contracting
Officer will make its full text available.

 
FAR Clause 52.246-8, Inspection of Research and Development - Cost-Reimbursement
(May 2001).  (Note: Work is deemed acceptable 90 days after delivery.)
 
SECTION F  - DELIVERIES OR PERFORMANCE
 
Deliveries and performance under these Contract Line Item Numbers (CLINs) and
Option CLINs shall be as follows:
 
ARTICLE F.1.  PERIOD OF PERFORMANCE
 
a.  
Under CLIN 0001, the base period of performance of this contract shall be from
7/19/2010-7/18/2012.

 
b.  
If the Government exercises its options pursuant to the OPTION CLAUSE Article in
Section H of the contract, the period of performance will be increased as listed
below:

 
OPTION CLIN
PERIOD OF PERFORM.
SUPPLIES/SERVICES
0002
 
RESERVED.
0003
[**]
[**]
0004
[**]
[**]
0005
[**]
[**]
0006
[**]
[**]
0007
[**]
[**]
0008
[**]
[**]

ARTICLE F.2. REPORTING REQUIREMENTS AND DELIVERABLES
 
Successful performance of the final contract shall be deemed to occur upon
performance of the work set forth in the Statement of Work dated 5 May 2010 set
forth in SECTION J-List of Attachments of this contract and upon delivery and
acceptance, as required by the Statement of Work, by the Contracting Officer, or
the duly authorized representative, of the following items in accordance with
the stated delivery schedule:
 
The items specified below as described in the REPORTING REQUIREMENTS Article in
SECTION C of this contract and the Statement of Work dated 5 May 2010 set forth
in SECTION J-List of Attachments will be required to be delivered
F.O.B.  Destination as set forth in FAR 52.247-35, F.O.B.  DESTINATION, WITHIN
CONSIGNEES PREMISES (APRIL 1984), and in accordance with and by the date(s)
specified below and any specifications stated in SECTION D, PACKAGING, MARKING
AND SHIPPING, of this contract:
 
1.           Other Contract Deliverables
 
Item
Deliverable
Quantity
Due Date
1.
Risk Management Plan
1 Electronic Copy Project
Officer (PO)
1 Hard Copy - PO
1 Electronic Copy -
Contracting Officer (CO)
1 Hard Copy - CO
Quarterly on the 15th day of
the month due or as
Determined by the Project
Officer.

 
2.           WBS Milestones/Deliverables and Technical Deliverables as contained
in the Statement of Work dated 5 May 2010 set forth in SECTION J-List of
Attachments.
 
 
The above items shall be addressed and delivered to:
 
Contracting Officer’s address:
AMCG 330 Independence Avenue, S.W.
Room G640
Washington, D.C.  20201
E-mail:  Ethan.Mueller@hhs.gov
 
Contracting Officer’s Technical Representative’s address:
BARDA
330 Independence Avenue, S.W.
Room G644
Washington, D.C.  20201
E-mail:  Eric.EspelandAhhs,gov
 

ARTICLE F.3. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)
 
The contract incorporates the following clause(s) by reference, with the same
force and effect as if it were given in full text.  Upon request, the
Contracting Officer will make its full text available.  Also, the full text of a
clause may be accessed electronically at this address:
http://www.acquisition.gov/comp/far/index.html
 
FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:
 
52.242-15, Stop Work Order (August 1989) with Alternate I (April 1984).
 
SECTION G - CONTRACT ADMINISTRATION DATA
 
ARTICLE G.1. CONTRACTING OFFICER
 
The following Contracting Officer will represent the Government for the purpose
of this contract:
 
Ethan J. Mueller, Contracting Officer
 
DHHS/OS/ASPR/AMCG
 
330 Independence Avenue, S.W.
 
Room 640G
 
Washington, D.C.  2020
 
E-mail:  Ethan.Mueller@hhs.gov
 
1)
The Contracting Officer is the only individual who can legally commit the
Government to the expenditure of public funds.  No person other than the
Contracting Officer can make any changes to the terms, conditions, general
provisions, or other stipulations of this contract.

 
2)
The Contracting Officer is the only person with the authority to act as agent of
the Government under this contract.  Only the Contracting Officer has authority
to (1) direct or negotiate any changes in the statement of work; (2) modify or
extend the period of performance; (3) change the delivery schedule; (4)
authorize reimburse to the Contractor of any costs incurred during the
performance of this contract; (5) otherwise change any terms and conditions of
this contract.

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

 
4)
The Government may unilaterally change its COTR designation.

 
ARTICLE G.2. CONTRACTING OFFICER’S TECHNICAL REPRESENTATIVE (COTR)
 
The following COTR will represent the Government for the purpose of this
contract:
 
1.           Dr. Eric Espeland, COTR
 
DHHS/OS/ASPR/BARDA
 
330 Independence Avenue, S.W.
 
Room 640G
 
Washington, D.C.  20201
 
E-mail:  Eric.Espeland@hhs.gov
 
The COTR is responsible for: (1) monitoring the Contractor’s technical progress,
including the surveillance and assessment of performance and recommending to the
Contracting Officer changes in requirements; (2) 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.
 
ARTICLE G.3. KEY PERSONNEL
 
Pursuant to the Key Personnel clause incorporated in Section I of this contract,
the following individuals are considered to be essential to the work being
performed hereunder:
 
#
NAME
ORGANIZATION
B55 SCALE-UP ROLE
1
[**]
EBOL
Program Manager
2
[**]
EBOL
Vice President Quality Assurance
3
[**]
EBSI
Senior Director Regulatory Affairs
4
[**]
EBSI
Non-Clinical Development Lead
5
[**]
EBSI
Senior Director Clinical Development
6
[**]
EBOL
Manufacturing Development Lead

 
The key personnel specified in this contract are considered to be essential to
work performance.  At least 30 business days prior to diverting any of the
specified individuals to other programs or contracts, including an instance when
an individual must be replaced as a result of leaving the employ of the
Contractor, the Contractor shall notify the Contracting Officer and shall submit
comprehensive justification for the diversion or replacement request (including
proposed substitutions for key personnel) to permit evaluation by the Government
of the impact on performance under this contract.  The Contractor shall not
divert or otherwise replace any key personnel without the written consent of the
Contracting Officer.  The Government may modify the contract to add or delete
key personnel at the request of the Contractor or Government.
 
ARTICLE G.4. CONTRACT FINANCIAL REPORT
 
a.           Financial reports on the attached Financial Report of Individual
Project/Contract shall be submitted by the Contractor in accordance with the
instructions for completing this form, which accompany the form, in an original
and two copies, 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 that part of the instructions for
completing this form, entitled “PREPARATION INSTRUCTIONS ,” all columns A
through J, shall be completed for each report submitted.
 
c.           The first financial report shall cover the period consisting of the
first full three calendar months following the date of the contract, in addition
to any fractional part of the initial month.  Thereafter, reports will be on a
quarterly basis.
 
d.           The Contracting Officer may require the Contractor to submit
detailed support for costs contained in one or more interim financial
reports.  This clause does not supersede the record retention requirements in
FAR Part 4.7.
 
e.           The listing of expenditure categories to be reported is
incorporated within the Attachment entitled, “Financial Report of Individual
Project/Contract,” located in SECTION J and made a part of this contract.
 
f.           The Government may unilaterally revise the “Financial Report of
Individual Project/Contract” to reflect the allotment of additional funds.
 
ARTICLE G.5. INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORTING
 
1)
The Contractor shall submit an electronic copy of monthly contract
invoices/financial reports to the address shown below:

 
DHHS/OS/ASPR/AMCG
 
 
Attn: Francine L. Hemphill, Contract Specialist
 
 
330 Independence Ave., S.W.
 
 
Room G640
 
 
Washington, D.C.  20201
 
2)
Contractor invoices/financial reports shall conform to the form, format, and
content requirements of the instructions for Invoice/Financing requests and
Contract Financial Reporting made a part of the contract in Section J.

 
3)
Monthly invoices must include the cumulative total expenses to date, adjusted
(as applicable) to show any amounts suspended by the Government.

 
4)
The Contractor agrees to immediately notify the Contracting Officer in writing
if there is an anticipated overrun (any amount) or unexpended balance (greater
than 10 percent) of the amount allotted to the contract, and the reasons for the
variance.  Also refer to the requirements of the Limitation of Cost (FAR
52.232-20) clause in the contract.

 
5)
All invoice submissions shall be in accordance with FAR Clause 52.232-25 in
Section I of this contract.

 
ARTICLE G.6. REIMBURSEMENT OF COST
 
1)
The Government shall reimburse the Contractor the cost determined by the
Contracting Officer to be allowable (hereinafter referred to as allowable cost)
in accordance with the clause entitled Allowable Cost and Payment in Section I,
Contract Clauses, and FAR Subpart 31.2.  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)
Special expenditures which, upon request from the Contractor, the Contracting
Officer approves as being an allowable cost under this contract, such as
purchase or lease of office furniture or equipment, etc.

 
 
e)
All travel costs plus per diem or actual subsistence for personnel while in an
actual travel status in direct performance of the work and services required
under this contract.  These costs will be in accordance with the Contractor’s
policy and subject to the following:

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

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

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

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

 
ARTICLE G.7. INDIRECT COST RATES
 
The following rates will be utilized for billing purposes during the base
period.  Fringe benefits at [**]%, development overhead at [**]% applied to a
base of sum of total direct labor plus fringe benefits, and G&A at [**]% applied
to a modified base that excludes subcontracts and equipment.  The billing rates
for each option period will be based on the incurred cost submission for the
previous calendar year, subject to Government audit adjustments.  Final rate
proposals must be sent to the Contractor’s cognizant audit agency, NIH Division
of Financial Advisory Services, as well as a copy to the Contracting Officer,
within 6 months subsequent to the fiscal year end.
 
ARTICLE G.8. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE
 
1. Contractor Performance Evaluations
 
Interim and final evaluations of Contractor performance will be prepared on this
contract in accordance with FAR Subpart 42.15.  The final performance evaluation
will be prepared at the time of completion of work.  In addition to the final
evaluation, an interim evaluation shall be submitted June 29, 2012.
 
Interim and final evaluations will be provided to the Contractor as soon as
practicable after completion of the evaluation.  The Contractor will be
permitted thirty days to review the document and to submit additional
information or a rebutting statement.  If agreement cannot be reached between
the parties, the matter will be referred to an individual one level above the
Contracting Officer whose decision will be final.
 
Copies of the evaluations, Contractor responses, and review comments, if any,
will be retained as part of the contract file, and may be used to support future
award decisions.
 
2. Electronic Access to Contractor Performance Evaluations
 
Contractors that have Internet capability may access evaluations through a
secure Web site for review and comment by completing the registration form that
can be obtained at the following address:
 
http://oamp.od.nih.gov/OD/CPS/cps.asp
 
The registration process requires the Contractor to identify an individual that
will serve as a primary contact and who will be authorized access to the
evaluation for review and comment.  In addition, the Contractor will be required
to identify an alternate contact who will be responsible for notifying the
cognizant contracting official in the event the primary contact is unavailable
to process the evaluation within the required 30-day time frame.
 
ARTICLE G.9. CONTRACT COMMUNICATIONS/CORRESPONDENCE (JULY 1999)
 
The Contractor shall identify all correspondence, reports, and other data
pertinent to this contract by imprinting the contract number from Page 1 of the
contract.
 
ARTICLE G.10. GOVERNMENT PROPERTY
 
1.           In addition to the requirements of the clause, GOVERNMENT PROPERTY,
incorporated in SECTION I of this contract, the Contractor shall comply with the
provisions of HHS Publication, “Contractor’s Guide for Control of Government
Property,” which is incorporated into this contract by reference.  This document
can be accessed at:
 
http://www.hhs.gov/oamp/policies/contractors_guidefor_control_of^govproperty.pdf
.
 
Among other issues, this publication provides a summary of the Contractor’s
responsibilities regarding purchasing authorizations and inventory and reporting
requirements under the contract.
 
2.           Notwithstanding the provisions outlined in the HHS Publication,
“Contractor’s Guide for Control of Government Property,” which is incorporated
in this contract in paragraph a. above, the Contractor shall use the form
entitled, “Report of Government Owned, Contractor Held Property” for submitting
summary reports required under this contract, as directed by the Contracting
Officer or his/her designee.  This form is included as an attachment in SECTION
J of this contract.
 
3.           Title will vest in the Government for equipment purchased as a
direct cost.
 
SECTION H - SPECIAL CONTRACT REQUIREMENTS
 
ARTICLE H.1. PROTECTION OF HUMAN SUBJECTS, HHSAR 352.270-8(b) (January 2006)
 
(a)           The Contractor agrees that the rights and welfare of human
subjects involved in research under this contract shall be protected in
accordance with 45 CFR Part 46 and with the Contractor’s current Assurance of
Compliance on file with the Office for Human Research Protections (OHRP), Office
of Public Health and Science (OPHS).  The Contractor further agrees to provide
certification at least annually that the Institutional Review Board has reviewed
and approved the procedures, which involve human subjects in accordance with 45
CFR Part 46 and the Assurance of Compliance.
 
(b)           The Contractor shall bear full responsibility for the performance
of all work and services involving the use of human subjects under this contract
and shall ensure that work is conducted in a proper manner and as safely as is
feasible.  The parties hereto agree that the Contractor retains the right to
control and direct the performance of all work under this contract.  Nothing in
this contract shall be deemed to constitute the Contractor or any subcontractor,
agent or employee of the Contractor, or any other person, organization,
institution, or group of any kind whatsoever, as the agent or employee of the
Government.  The Contractor agrees that it has entered into this contract and
will discharge its obligations, duties, and undertakings and the work pursuant
thereto, whether requiring professional judgment or otherwise, as an independent
contractor without imputing liability on the part of the Government for the acts
of the Contractor or its employees.
 
(c)           If at any time during the performance of this contract, the
Contracting Officer determines, in consultation with the OHRP, OPHS, ASH, that
the Contractor is not in compliance with any of the requirements and/or
standards stated in paragraphs (a) and (b) above, the Contracting Officer may
immediately suspend, in whole or in part, work and further payments under this
contract until the Contractor corrects the noncompliance.  Notice of the
suspension may be communicated by telephone and confirmed in writing.  If the
Contractor fails to complete corrective action within the period of time
designated in the Contracting Officer’s written notice of suspension, the
Contracting Officer may, in consultation with OHRP, OPHS, ASH, terminate this
contract in a whole or in part, and the Contractor’s name may be removed form
the list of those contractors with approved Health and Human Services Human
Subject Assurances.
 
ARTICLE H.2. HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE)
 
The acquisition and supply of all human specimen material (including fetal
material) used under this contract shall be obtained by the Contractor in full
compliance with applicable Federal, State and Local laws and the provisions of
the Uniform Anatomical Gift Act in the United States, and no undue inducements,
monetary or otherwise, will be offered to any person to influence their donation
of human material.
 
The Contractor shall provide written documentation that all human materials
obtained as a result of research involving human subjects conducted under this
contract, by collaborating sites, or by subcontractors identified under this
contract, were obtained with prior approval by the Office for Human Research
Protections (OHRP) of an Assurance to comply with the requirements of 45 CFR 46
to protect human research subjects.  This restriction applies to all
collaborating sites without OHRP-approved Assurances, whether domestic or
foreign, and compliance must be ensured by the Contractor.
 
Provision by the Contractor to the Contracting Officer of a properly completed
“Protection of Human Subjects Assurance Identification/IRB
Certification/Declaration of Exemption”, Form OMB No. 0990-0263(formerly
Optional Form 310), certifying IRB review and approval of the protocol from
which the human materials were obtained constitutes the written documentation
required.  The human subject certification can be met by submission of a self
designated form provided that it contains the information required by the
“Protection of Human Subjects Assurance Identification/IRB
Certification/Declaration of Exemption”, Form OMB No. 0990-0263 (formerly
Optional Form 310).
 
ARTICLE H.3. RESEARCH INVOLVING HUMAN FETAL TISSUE
 
All research involving human fetal tissue shall be conducted in accordance with
the Public Health Service Act, 42 U.S.C. 289g-l and 289g-2.  Implementing
regulations and guidance for conducting research on human fetal tissue may be
found at 45 CFR 46, Subpart B and
http://grantsl.nih.gov/grants/guide/notice-files/not93-235.html and any
subsequent revisions to this NIH Guide to Grants and Contracts (“Guide”) Notice.
 
The Contractor shall make available, for audit by the Secretary, HHS, the
physician statements and informed consents required by 42 USC 289g-l(b) and (c),
or ensure HHS access to those records, if maintained by an entity other than the
Contractor.
 
ARTICLE H.4. NEEDLE EXCHANGE
 
The Contractor shall not use contract funds to carry out any program of
distributing sterile needles or syringes for the hypodermic injection of any
illegal drug.
 
ARTICLE H.5. PRESS RELEASES
 
The Contractor shall clearly state, when issuing statements, press releases,
requests for proposals, bid solicitations and other documents describing
projects or programs funded in whole or in part with Federal money: (1) the
percentage of the total costs of the program or project which will be financed
with Federal money; (2) the dollar amount of Federal funds for the project or
program; and (3) the percentage and dollar amount of the total costs of the
project or program that will be financed by nongovernmental sources.
 
ARTICLE H.6. CARE OF LIVE VERTEBRATE ANIMALS, HHSAR 352.270-9(b) (January 2006)
 
(a)           Before undertaking performance of any contract involving animal
related activities, the Contractor shall register with the Secretary of
Agriculture of the United States in accordance with 7 U.S.C.  2136 and 9 CFR
2.25 through 2.28.  The Contractor shall furnish evidence of the registration to
the Contracting Officer.
 
(b)           The Contractor shall acquire vertebrate animals used in research
from a dealer licensed by the Secretary of Agriculture under 7 U.S.C.  2133 and
9 CFR 2.1 through 2.11, or from a source that is exempt from licensing under
those sections.
 
(c)           The Contractor agrees that the care and use of any live vertebrate
animals used or intended for use in the performance of this contract will
conform with the PHS Policy on Humane Care of Use of Laboratory Animals, the
current Animal Welfare Assurance, the Guide for the Care and Use of Laboratory
Animals prepared by the Institute of Laboratory Animal Resources and the
pertinent laws and regulations of the United States Department of Agriculture (
see 7 U.S.C.  2131 et seq. and 9 CFR Subchapter A, Parts 1 - 4).  In case of
conflict between standards, the more stringent standard shall be used.
 
(d)           If at any time during performance of this contract, the
Contracting Officer determines, in consultation with the Office of Laboratory
Animal Welfare (OLAW), National Institutes of Health (NIH), that the Contractor
is not in compliance with any of the requirements and/or standards stated in
paragraphs (a) through (c) above, the Contracting Officer may immediately
suspend, in whole or in part, work and further payments under this contract
until the Contractor corrects the noncompliance.  Notice of the suspension may
be communicated by telephone and confirmed in writing.  If the Contractor fails
to complete corrective action within the period of time designated in the
Contracting Officer’s written notice of suspension, the Contracting Officer may,
in consultation with OLAW, NIH, terminate this contract in whole or in part, and
the Contractor’s name may be removed from the list of those contractors with
approved PFIS Animal Welfare  Assurances.
 
Note: The Contractor may request registration of its facility and a current
listing of licensed dealers from the Regional Office of the Animal and Plant
Health Inspection Service (APHIS), USDA, for the region in which its research
facility is located.  The location of the appropriate APHIS Regional Office, as
well as information concerning this program may be obtained by contacting the
Animal Care Staff, USDA/APHIS, 4700 River Road, Riverdale, Maryland 20737.
 
(End of Clause)
 
ARTICLE H.7. ANIMAL WELFARE
 
All research involving live, vertebrate animals shall be conducted in accordance
with the Public Health Service Policy on Humane Care and Use of Laboratory
Animals.  This policy may be accessed at:
 
http ://grants 1.nih.gov/grants/olaw/references/phspol.htm .
 
ARTICLE H.8. PROTECTION OF PERSONNEL WHO WORK WITH NONHUMAN PRIMATES
 
All Contractor personnel who work with nonhuman primates or enter rooms or areas
containing nonhuman primates shall comply with the procedures set forth in NIH
Policy Manual 3044-2, entitled, “Protection of NIH Personnel Who Work with
Nonhuman Primates,” located at the following URL:
 
http://wwwl.od.nih.gov/oma/manualchapters/intramural/3044-2/
 
ARTICLE H.9. PUBLICATION AND PUBLICITY
 
No information related to data obtained under this contract shall be released or
publicized without the prior written consent of the Contracting Officer
Technical Representative.
 
In addition to the requirements set forth in HHSAR Clause 352.270-6,
Publications and Publicity incorporated by reference in SECTION I of this
contract, the Contractor shall acknowledge the support of the Biomedical
Advanced Research and Development Authority whenever publicizing the work under
this contract in any media by including an acknowledgment substantially as
follows:
 
“This project has been funded in whole or in part with Federal funds from the
Biomedical Advanced Research and Development Authority, Office of the Assistant
Secretary for Preparedness and Response, Office of the Secretary, Department of
Health and Human Services, under Contract No. ______________”
 
ARTICLE H.10. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE
 
Anyone who becomes aware of the existence or apparent existence of fraud, waste
and abuse in BARDA funded programs is encouraged to report such matters to the
HHS Inspector General’s Office in writing or on the Inspector General’s
Hotline.  The toll free number is 1-800-HHS-TIPS (1-800-447-8477).  All
telephone calls will be handled confidentially.  The e-mail address
is  Htips@os.dlihs.gov and the mailing address is:
 
Office of Inspector General
 
Department of Health and Human Services
 
TIPS HOTLINE
 
P.O. Box 23489
 
Washington, D.C.  20026
 
ARTICLE H.11. PROHIBITION ON CONTRACTOR INVOLVEMENT 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.12. CONFLICT OF INTEREST
 
The Contractor represents and warrants that, to the best of the Contractor’s
knowledge and belief, there are no relevant facts or circumstances which could
give rise to an organizational conflict of interest, as defined in FAR Subpart
9.5, or that the Contractor has disclosed all such relevant information.  Prior
to commencement of any work, the Contractor agrees to notify the Contracting
Officer promptly that, to the best of its knowledge and belief, no actual or
potential conflict of interest exists or to identify to the Contracting Officer
any actual or potential conflict of interest the firm may have.  In emergency
situations, however, work may begin but notification shall be made within five
(5) working days.  The Contractor agrees that if an actual or potential
organizational conflict of interest is identified during performance, the
Contractor shall promptly make a full disclosure in writing to the Contracting
Officer.  This disclosure shall include a description of actions, which the
Contractor has taken or proposes to take, after consultation with the
Contracting Officer, to avoid, mitigate, or neutralize the actual or potential
conflict of interest.  The Contractor shall continue performance until notified
by the Contracting Officer of any contrary action to be taken.  Remedies include
termination of this contract for convenience, in whole or in part, if the
Contracting Officer deems such termination necessary to avoid an organizational
conflict of interest.  If the Contractor was aware of a potential organizational
conflict of interest prior to award or discovered an actual or potential
conflict after award and did not disclose it or misrepresented relevant
information to the Contracting Officer, the Government may terminate the
contract for default, debar the Contractor from Government contracting, or
pursue such other remedies as may be permitted by law or this contract.
 
ARTICLE H.13. EXERCISE OF OPTIONS
 
Unless the Government exercises its option pursuant to the Option Clause set
forth in Section I, Article I.I, the contract will consist only of CLIN 0001 of
the Statement of Work, Deliverables and Requirements as defined in Sections C, F
and J of the contract.  Pursuant to FAR Clause 52.217-7 (Option for Increased
Quantity) set forth in Section I of this contract, under Article I.I., the
Government may, by unilateral contract modification, require the Contractor to
perform any of the additional CLIN’s listed in Section B, Article B.3., and as
also defined in Sections C, F and J of this contract.  If the Government
exercises an option, notice must be given at least 60 days prior to the
expiration date of this contract.  The amount of the contract will then be
increased as set forth in Section B, Article B.3
 
ARTICLE H.14. PROHIBITION ON THE USE OF APPROPRIATED FUNDS FOR LOBBYING
ACTIVITIES AND HHSAR 352.270-10 ANTI-LOBBYING (Jan 2006)
 
The Contractor is hereby notified of the restrictions on the use of Department
of Health and Human Service’s funding for lobbying of Federal, State and Local
legislative bodies.
 
Section 1352 of Title 10, United Stated Code (Public Law 101-121, effective
12/23/89), among other things, prohibits a recipient (and their subcontractors)
of a Federal contract, grant, loan, or cooperative agreement from using
appropriated funds (other than profits from a federal contract) to pay any
person for influencing or attempting to influence an officer or employee of any
agency, a Member of Congress, an officer or employee of Congress, or an employee
of a Member of Congress in connection with any of the following covered Federal
actions; the awarding of any Federal contract; the making of any Federal grant;
the making of any Federal loan; the entering into of any cooperative agreement;
or the modification of any Federal contract, grant, loan, or cooperative
agreement.  For additional information of prohibitions against lobbying
activities, see FAR Subpart 3.8 and FAR Clause 52.203-12.
 
In addition, as set forth in HHSAR 352.270-10 “Anti-Lobbying” (January 2006),
the current Department of Health and Human Services Appropriations Act provides
that no part of any appropriation contained in this Act shall be used, other
than for normal and recognized executive-legislative relationships, for
publicity or propaganda purposes, for the preparation, distribution, or use of
any kit, pamphlet, booklet, publication, radio, television, or video
presentation designed to support, or defeat legislation pending before the
Congress, or any State or Local legislature except in presentation to the
Congress, or any State or Local legislative body itself.
 
The current Department of Health and Human Services Appropriations Act also
provides that no part of any appropriation contained in this Act shall be used
to pay the salary or expenses of any contract or grant recipient, or agent
acting for such recipient, related to any activity designed to influence
legislation or appropriations pending before the Congress, or any State or Local
legislature.
 
ARTICLE H.15. PRIVACY ACT APPLICABILITY (Apr 2000)
 
1)
Notification is hereby given that the Contractor and its employees are subject
to criminal penalties for violation of the Privacy Act to the same extent as
employees of the Government.  The Contractor shall assure that each of its
employees knows the prescribed rules of conduct and that each is aware that he
or she can be subjected to criminal penalty for violation of the Act.  A copy of
45 CFR Part 5b, Privacy Act Regulations, may be obtained at
http://www.gpoaccess.gov/cfr/index.html

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

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

 
Note: Clinical trials cannot be initiated until the System Notice has been
published and the Contracting Officer notifies the Contractor.
 
ARTICLE H.16.  LABORATORY LICENSE REQUIREMENTS (May 1998)
 
The Contractor shall comply with all applicable requirements of Section 353 of
the Public Health Service Act (Clinical Laboratory Improvement Act as
amended).  This requirement shall also be included in any subcontract for
services under the contract.
 
ARTICLE H.17.  DISSEMINATION OF INFORMATION (May 1998)
 
No information related to data obtained under this contract shall be released or
publicized without the prior written consent of the Contracting Officer.
 
ARTICLE H.18.  IDENTIFICATION AND DISPOSITION OF DATA
 
The Contractor will be required to 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 directly related to
and/or generated under 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.19.   INFORMATION ON COMPLIANCE WITH ANIMAL CARE REQUIREMENTS
 
Registration with the U. S. Dept. of Agriculture (USD A) 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.mh.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/usdalegl.htm issued by the U.S. Department
of Agriculture (USDA) under the Animal Welfare Act.  The Guide may differ from
USDA regulations in some respects.  Compliance with the USDA regulations is an
absolute requirement of this Policy.
 
The Association for Assessment and Accreditation of Laboratory Animal Care
International (AAALAC) http://www.aaalac.org is a professional organization that
inspects and evaluates programs of animal care for institutions at their
request.  Those that meet the high standards are given the accredited
status.  As of the 2002 revision of the PHS Policy, the only accrediting body
recognized by PHS is the AAALAC.  While AAALAC Accreditation is not required to
conduct biomedical research, it is highly desirable.  AAALAC uses the Guide as
their primary evaluation tool.  They also use the Guide for the Care and Use of
Agricultural Animals in Agricultural Research and Teaching.  It is published by
the Federated of Animal Science Societies http://www.fass.org.
 
ARTICLE H.20.   REQUIREMENTS FOR ADEQUATE ASSURANCE OF PROTECTION OF VERTEBRATE
ANIMAL SUBJECTS
 
The PHS Policy on Humane Care and Use of Laboratory Animals requires that
applicant organizations proposing to use vertebrate animals file a written
Animal Welfare Assurance with the Office for Laboratory Animal Welfare (OLAW),
establishing appropriate policies and procedures to ensure the humane care and
use of live vertebrate animals involved in research activities supported by the
PHS.  The PHS Policy stipulates that an applicant organization, whether domestic
or foreign, bears responsibility for the humane care and use of animals in
PHS-supported research activities.  Also, the PHS policy defines “animal” as
“any live, vertebrate animal used, or intended for use, in research, research
training, experimentation, biological testing or for related purposes.”  This
Policy implements and supplements the U.S. Government Principles for the
Utilization and Care of Vertebrate Animals Used in Testing, Research, and
Training, and requires that institutions use the Guide for the Care and Use of
Laboratory Animals as a basis for developing and implementing an institutional
animal care and use program.  This Policy does not affect applicable State or
local laws or regulations that impose more stringent standards for the care and
use of laboratory animals.  All institutions are required to comply, as
applicable, with the Animal Welfare Act as amended (7 USC 2131 et.  seq.) and
other Federal statutes and regulations relating to animals.  These documents are
available from the Office of Laboratory Animal Welfare, National Institutes of
Health, Bethesda, MD 20892, (301) 496-7163.  See
http://grants.nih.gov/grants/olaw/olaw.htm.
 
No PHS supported work for research involving vertebrate animals will be
conducted by an organization, unless that organization is operating in
accordance with an approved Animal Welfare Assurance and provides verification
that the Institutional Animal Care and Use Committee (IACUC) has reviewed and
approved the proposed activity in accordance with the PHS policy.  Applications
may be referred by the PHS back to the institution for further review in the
case of apparent or potential violations of the PHS Policy.  No award to an
individual will be made unless that individual is affiliated with an assured
organization that accepts responsibility for compliance with the PHS
Policy.  Foreign applicant organizations applying for PHS awards for activities
involving vertebrate animals are required to comply with PHS Policy or provide
evidence that acceptable standards for the humane care and use of animals will
be met.  Foreign applicant organizations are not required to submit IACUC
approval, but should provide information that is satisfactory to the Government
to provide assurances for the humane care of such animals.
 
ARTICLE H.21.   APPROVAL OF REQUIRED ASSURANCE BY OLAW
 
Under governing regulations, federal funds which are administered by the
Department of Health and Human Services, Office of Biomedical Advanced Research
and Development Authority (BARDA) shall not be expended by the Contractor for
research involving live vertebrate animals, nor shall live vertebrate animals be
involved in research activities by the Contractor under this award unless a
satisfactory assurance of compliance with 7 U.S.C. 2316 and 9 CFR Sections
2.25-2.28 is submitted within 30 days of the date of this award and approved by
the Office of Laboratory Animal Welfare (OLAW).  Each performance site (if any)
must also assure compliance with 7 U.S.C. 2316 and 9 CFR Sections 2.25-2.28 with
the following restriction: Only activities which do not directly involve live
vertebrate animals (i.e. are clearly severable and independent from those
activities that do involve live vertebrate animals) may be conducted by the
Contractor or individual performance sites pending OLAW approval of their
respective assurance of compliance with 7 U.S.C. 2316 and 9 CFR Sections
2.25-2.28.  Additional information regarding OLAW may be obtained via the
Internet at http://grants2.nih.gov/grants/olaw/references/phspol.htm.
 
ARTICLE H.22.   REGISTRATION WITH THE SELECT AGENT PROGRAM FOR WORK INVOLVING
THE POSSESSION, USE, AND/OR TRANSFER OF SELECT BIOLOGICAL AGENTS OR TOXINS
 
Work involving select biological agents or toxins shall not be conducted under
this contract until the Contractor and any affected subcontractor(s) are granted
a certificate of registration or are authorized to work with the applicable
select agents.
 
For prime or subcontract awards to domestic institutions who possess, use,
and/or transfer Select Agents under this contract, the institution must complete
registration with the Centers for Disease Control and Prevention (CDC),
Department of Health and Human Services (DHHS) or the Animal and Plant Health
Inspection Services (APHIS), U.S. Department of Agriculture (USDA), as
applicable, before performing work involving Select Agents, in accordance with
42 CFR 73.  No Government funds can be used for work involving Select Agents, as
defined in 42 CFR 73, if the final registration certificate is denied.
 
For prime or subcontract awards to foreign institutions who possess, use, and/or
transfer Select Agents under this contract, the institution must provide
information satisfactory to the Government that a process equivalent to that
described in 42 CFR 73 (http://www.cdc.eov/od/sap/docs/42cfr73.pdf) for U.S.
institutions is in place and will be administered on behalf of all Select Agent
work sponsored by these funds before using these funds for any work directly
involving the Select Agents.  The Contractor must provide information addressing
the following key elements appropriate for the foreign institution: safety,
security, training, procedures for ensuring that only approved/appropriate
individuals have access to the Select Agents, and any applicable laws,
regulations and policies equivalent to 42 CFR 73.  The Government will assess
the policies and procedures for comparability to the U.S. requirements described
in 42 CFR Part 73.  When requested by the contracting officer, the Contractor
shall provide key information delineating any laws, regulations, policies, and
procedures applicable to the foreign institution for the safe and secure
possession, use, and transfer of Select Agents.  This includes summaries of
safety, security, and training plans, and applicable laws, regulations, and
policies.  For the purpose of security risk assessments, the Contractor must
provide the names of all individuals at the foreign institution who will have
access to the Select Agents and procedures for ensuring that only approved and
appropriate individuals have access to Select Agents under the contract.
 
Listings of HHS select agents and toxins, biologic agents and toxins, and
overlap agents or toxins as well as information about the registration process,
can be obtained on the Select Agent Program Web site at http
://www.cdc.gov/od/sap/.
 
ARTICLE H.23.   EPA ENERGY STAR REQUIREMENTS
 
In compliance with Executive Order 12845 (requiring Agencies to purchase energy
efficient computer equipment) all microcomputers, including personal computers,
monitors, and printers that are purchased using Government funds in performance
of a contract shall be equipped with or meet the energy efficient low-power
standby feature as defined by the EPA Energy Star program unless the equipment
always meets EPA Energy Star efficiency levels.  The microcomputer, as
configured with all components, must be Energy Star compliant.
 
This low-power feature must already be activated when the computer equipment is
delivered to the agency and be of equivalent functionality of similar power
managed models.  If the equipment will be used on a local area network, the
vendor must provide equipment that is fully compatible with the network
environment.  In addition, the equipment will run commercial off-the-shelf
software both before and after recovery from its energy conservation mode.
 
ARTICLE H.24.   ACKNOWLEDGMENT OF FEDERAL FUNDING
 
A.
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.

 
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.
 
B.
Publication and Publicity

 
Publications: Any manuscript or scientific meeting abstract containing data
generated under this contract must be submitted for BARD A Project Officer
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.  A “publication” is defined as an issue of printed material
offered for distribution or any communication or oral presentation of
information.
 
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
Office of the Assistant Secretary for Preparedness and Response, Biomedical
Advanced Research and Development Authority, under Contract No.
HHSO100201000034C.”
 
C.           Press Releases
 
a.  
Pursuant to Section 508 of Public Law 105-78, the Contractor shall clearly
state, when issuing statements, press releases, requests for proposals, bid
solicitations and other documents describing projects or programs funded in
whole or in part with Federal money that: (1) the percentage of the total costs
of the program or project which will be financed with Federal money; (2) the
dollar amount of Federal funds for the project or program; and (3) the
percentage and dollar amount of the total costs of the project or program that
will be financed by nongovernmental sources.

 
b.  
The Contractor agrees to accurately and factually represent the work conducted
under this contract in all press releases.  Misrepresenting contract results or
releasing information that is injurious to the integrity of BARDA may be
construed as improper conduct.  Press releases shall be considered to include
the public release of information to any medium, excluding peer-reviewed
scientific publications.  The Contractor shall ensure that the Project Officer
has received an advance copy of any press release related to this contract not
less than four (4) working days prior to the issuance of the press release.

 
ARTICLE H.25.   MANUFACTURING STANDARDS
 
The Good Manufacturing Practice Regulations (GMP)(21 CFR Parts 210-211) and
regulations pertaining to biological products (21 CFR Part 600) and regulations
pertaining to diagnostic products (21 CFR Part 860) will be the standard to be
applied for manufacturing, processing, packaging, storage and delivery of this
product.
 
If at any time during the life of the contract, the Contractor fails to comply
with GMP in the manufacturing, processing, packaging, storage, stability and
other testing of the manufactured drug substance or product and delivery of this
product and such failure results in a material adverse effect on the safety,
purity or potency of the product (a material failure) as identified by the FDA,
the Contractor shall have thirty (30) calendar days from the time such material
failure is identified to cure such material failure.  If, within the thirty (30)
calendar day period, the Contractor fails to take such an action to the
satisfaction of the USG Project Officer, or fails to provide a remediation plan
that is acceptable to the Project Officer, then the contract may be terminated.
 
ARTICLE H.26.   EXPORT CONTROL NOTIFICATION
 
Offerors are responsible for ensuring compliance with all export control laws
and regulations that maybe applicable to the export of and foreign access to
their proposed technologies.  Offerors may consult with the Department of State
with any questions regarding the International Traffic in Arms Regulation (ITAR)
(22 CRF Parts 120-130) and /or the Department of Commerce regarding the Export
Administration Regulations (15 CRF Parts 730-774).
 
ARTICLE H.27.   SUBCONTRACTING PROVISIONS
 
a.  
Small Business Subcontracting Plan

 
1. The Small Business Subcontracting Plan, dated 5 May 2010 is attached hereto
and made a part of this contract.
 
2. The failure of any Contractor or subcontractor to comply in good faith with
FAR Clause 52.219-8, entitled “Utilization of Small Business Concerns”
incorporated in this contract and the attached Subcontracting Plan, will be a
material breach of such contract or subcontract and subject to the remedies
reserved to the Government under FAR Clause 52.219-16 entitled, “Liquidated
Damages- Subcontracting Plan.”
 
b.  
Subcontracting Reports

 
The Contractor shall submit the following Subcontracting reports electronically
via the “electronic Subcontracting Reporting System (eSRS) at
http://www.esrs.gov .
 
a.           Individual Subcontract Reports (ISR)
 
Regardless of the effective date of this contract, the Report shall be due on
the following dates for the entire life of this contract:
 
October 30th
 
April 30th
 
Expiration Date of Contract
 
b.           Summary Subcontract Report (SSR)
 
Regardless of the effective date of this contract, the Summary Subcontract
Report shall be submitted annually on the following date for the entire life of
this contract:
 
April 30th
 
For both the Individual and Summary Subcontract Reports, the Contract Specialist
shall be included as a contact for notification purposes at the following e-mail
address:
 
Francine L. Hemphill, Contracting Specialist
 
DHHS/OS/ASPR/BARDA
 
E-mail: Francine.Hemphill@hhs.gov
 
ARTICLE H.28.   INSTITUTIONAL  RESPONSIBILITY  REGARDING  CONFLICTING INTERESTS
OF INVESTIGATORS
 
The Contractor shall comply with the requirements of 45 CFR Part 94, Responsible
Prospective Contractors, which promotes objectivity in research by establishing
standards to ensure that investigators (defined as the principal investigator
and any other person who is responsible for the design, conduct, or reporting of
research funded under BARDA contracts) will not be biased by any conflicting
financial interest.  For the purposes of this part relating to financial
interests, “Investigator” includes the Investigator’s spouse and dependent
children.  45 CFR Part 94 is available at the following Web site:
 
htlp://ecfr.gpoaccess.gov/cgi/ I/text/
texl-idx?c=ecfr;sid=9fl30b6d2d48bb73803ca91ce943be3a:rgn-div5;view=text:node=45%3A1.0.1.1,53;idno=45;cc
=ecfr
 
As required by 45 CFR Part 94, the Contractor shall, at a minimum:
 
a.           Maintain a written, enforceable policy on conflict of interest that
complies with 45 CFR Part 94 and inform each investigator of the policy, the
investigator’s reporting responsibilities, and the applicable regulations.  The
Contractor must take reasonable steps to ensure that investigators working as
collaborators or subcontractors comply with the regulations.
 
b.           Designate an official(s) to solicit and review financial disclosure
statements from each investigator participating in BARDA-funded research.  Based
on established guidelines consistent with the regulations, the designated
official(s) must determine whether a conflict of interest exists, and if so,
determine what actions should be taken to manage, reduce, or eliminate such
conflict.  A conflict of interest exists when the designated official(s)
reasonably determines that a Significant Financial Interest could directly and
significantly affect the design, conduct, or reporting of the BARDA-funded
research.  The Contractor may require the management of other conflicting
financial interests in addition to those described in this paragraph, as it
deems appropriate.  Examples of conditions or restrictions that might be imposed
to manage actual or potential conflicts of interests are included in 45 CFR Part
94, under Management of Conflicting Interests.
 
c.           Require all financial disclosures to be updated during the period
of the award, either on an annual basis or as new reportable Significant
Financial Interests are obtained.
 
d.           Maintain records, identifiable to each award, of all financial
disclosures and all actions taken by the Contractor with respect to each
conflicting interest 3 years after final payment or, where applicable, for the
other time periods specified in 48 CFR Part 4, subpart 4.7, Contract Records
Retention.
 
e.           Establish adequate enforcement mechanisms and provide for sanctions
where appropriate.
 
If a conflict of interest is identified, the Contractor shall report to the
Contracting Officer the existence of the conflicting interest found.  This
report shall be made and the conflicting interest managed, reduced, or
eliminated, at least on a temporary basis, within sixty (60) days of that
identification.
 
If the failure of an investigator to comply with the conflict of interest policy
has biased the design, conduct, or reporting of the BARDA-funded research, the
Contractor must promptly notify the Contracting Officer of the corrective action
taken or to be taken.  The Contracting Officer will take appropriate action or
refer the matter to the Contractor for further action which may include
directions to the Contractor on how to maintain appropriate objectivity in the
funded research.
 
The Contracting Officer may at any time inquire into the Contractor’s procedures
and actions regarding conflicts of interests in BARDA-funded research including
a review of all records pertinent to compliance with 45 CFR Part 94.  The
Contracting Officer may require submission of the records or review them on
site.  On the basis of this review, the Contracting Officer may decide that a
particular conflict of interest will bias the objectivity of the BARDA-funded
research to such an extent that further corrective action is needed or that the
Contractor has not managed, reduced, or eliminated the conflict of
interest.  The issuance of a Stop Work Order by the Contracting Officer may be
necessary until the matter is resolved.
 
If the Contracting Officer determines that BARDA-funded clinical research, whose
purpose is to evaluate the safety or effectiveness of a drug, medical device, or
treatment, has been designed, conducted, or reported by an investigator with a
conflict of interest that was not disclosed or managed, the Contractor must
require disclosure of the conflict of interest in each public presentation of
the results of the research.
 
ARTICLE H.29.   HUMAN MATERIALS
 
It is understood that the acquisition and supply of all human specimen material
(including fetal material) used under this contract will be obtained by the
Contractor in full compliance with applicable State and Local laws and the
provisions of the Uniform Anatomical Gift Act in the United States and that no
undue inducements, monetary or otherwise, will be offered to any person to
influence their donation of human material.
 
ARTICLE H.30.   REGISTRATION WITH THE SELECT AGENT PROGRAM FOR WORK INVOLVING
THE POSSESSION, USE, AND/OR TRANSFER OF SELECT BIOLOGICAL AGENTS OR TOXINS
 
Work involving select biological agents or toxins shall not be conducted under
this contract until the Contractor and any affected subcontractor(s) are granted
a certificate of registration or are authorized to work with the applicable
select agents.
 
For prime or subcontract awards to domestic institutions who possess, use,
and/or transfer Select Agents under this contract, the institution must complete
registration with the Centers for Disease Control and Prevention (CDC),
Department of Health and Human Services (DHHS) or the Animal and Plant Health
Inspection Services (APHIS), U.S. Department of Agriculture (USDA), as
applicable, before performing work involving Select Agents, in accordance with
42 CFR 73.  No Government funds can be used for work involving Select Agents, as
defined in 42 CFR 73, if the final registration certificate is denied.
 
For prime or subcontract awards to foreign institutions who possess, use, and/or
transfer Select Agents under this contract, the institution must provide
information satisfactory to the Government that a process equivalent to that
described in 42 CFR 73 (http://www.cdc.eov/od/sap/docs/42cfr73.pdf ) for U.S.
institutions is in place and will be administered on behalf of all Select Agent
work sponsored by these funds before using these funds for any work directly
involving the Select Agents.  The Contractor must provide information addressing
the following key elements appropriate for the foreign institution: safety,
security, training, procedures for ensuring that only approved/appropriate
individuals have access to the Select Agents, and any applicable laws,
regulations and policies equivalent to 42 CFR 73.  The Government will assess
the policies and procedures for comparability to the U.S. requirements described
in 42 CFR Part 73.  When requested by the contracting officer, the Contractor
shall provide key information delineating any laws, regulations, policies, and
procedures applicable to the foreign institution for the safe and secure
possession, use, and transfer of Select Agents.  This includes summaries of
safety, security, and training plans, and applicable laws, regulations, and
policies.  For the purpose of security risk assessments, the Contractor must
provide the names of all individuals at the foreign institution who will have
access to the Select Agents and procedures for ensuring that only approved and
appropriate individuals have access to Select Agents under the contract.
 
Listings of HHS select agents and toxins, biologic agents and toxins, and
overlap agents or toxins as well as information about the registration process,
can be obtained on the Select Agent Program Web site at
http://www.cdc.gov/od/sap/.
 
PART II - PART II - CONTRACT CLAUSES
 
SECTION I - CONTRACT CLAUSES
 
ARTICLE I.I.  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: http://www.arnet.gov
 
General Clauses for Cost-Reimbursement Research and Development
 
(1)           FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:
 
FAR
CLAUSE NO.
 
DATE
TITLE
  52.202-1  
Jul 2004
Definitions
 
  52.203-3  
Apr 1984
Gratuities (Over $100,000)
 
  52.203-5  
Apr 1984
Covenant Against Contingent Fees (Over $100,000)
 
  52.203-6  
Sep 2006
Restrictions on Subcontractor Sales to the Government (Over $100,000)
 
  52.203-7  
Jul 1995
Anti-Kickback Procedures (Over $100,000)
 
  52.203-8  
Jan 1997
Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity
(Over $100,000)
 
  52.203-10  
Jan 1997
Price or Fee Adjustment for Illegal or Improper Activity (Over $100,000)
 
  52.203-12  
Sep 2007
Limitation on Payments to Influence Certain Federal Transactions (Over $100,000)
 
  52.203-13  
Apr 2010
Contractor Code of Business Ethics and Conduct
 
  52.203-14  
Dec 2007
Display of Hotline Poster
 
  52.204-4  
Aug 2000
Printed or Copied Double-Sided on Recycled Paper (Over $100,000)
 
  52.204-7  
Apr 2008
Central Contractor Registration
 
  52.209-6  
Sep 2006
Protecting the Government’s Interests When Subcontracting With Contractors
Debarred, Suspended, or Proposed for Debarment (Over $25,000) Audit and Records
- Negotiation (Over $100,000)
 
  52.215-2  
Mar 2009
Order of Precedence - Uniform Contract Format Price Reduction for Defective Cost
or Pricing Data Subcontractor Cost or Pricing Data (Over $500,000) Integrity of
Unit Prices (Over $100,000) Pension Adjustments and Asset Reversions
 
  52.215-8  
Oct 1997
Order of Precedence – Uniform Contract Format
 
  52.215-10  
Oct 1997
Price Reduction for Defective Cost of Pricing Data
 
  52.215-12  
Oct 1997
Subcontractor Cost or Pricing  Date (Over $500,000)
 
  52.215-14  
Oct 1997
Integrity of Unit Prices (Over $100,000)
 
  52.215-15  
Oct 2004
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 1997
Requirements for Cost or Pricing Data or Information Other Than Cost or Pricing
Data - Modifications
 
  52.216-7  
Dec 2002
Allowable Cost and Payment (Note: the following language is included in this
clause - “(3) The designated payment office will make interim payments for
contract financing on the 30th day after the designated billing office receives
a proper payment request...”
  52.219-8  
May 2004
Utilization of Small Business Concerns (Over $100,000)
 
  52.219-9  
Apr 2008
Small Business Subcontracting Plan (Over $500,000)
 
  52.219-16  
Jan 1999
Liquidated Damages - Subcontracting Plan (Over $500,000)
 
  52.222-19  
Aug 2009
Child Labor - Cooperation with Authorities and Remedies
 
  52.222-3  
Jun 2003
Convict Labor
 
  52.222-21  
Feb 1999
Prohibition of Segregated Facilities
 
  52.222-26  
Mar 2007
Equal Opportunity
 
  52.222-35  
Sep 2006
Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era,
and
Other Eligible Veterans
 
  52.222-36  
Jun 1998
Affirmative Action for Workers with Disabilities
 
  52.222-37  
Sep 2006
Employment Reports on Special Disabled Veterans, Veterans of  the Vietnam Era,
and Other Eligible Veterans
 
  52.222-50  
Feb 2009
Combating Trafficking in Persons
 
  52.222-54  
Jan 2009
Employment Eligibility Verification
 
  52.223-6  
May 2001
Drug-Free Workplace
 
  52.223-14  
Aug 2003
Toxic Chemical Release Reporting (Over $100,000)
 
  52.224-1  
April 1984
Privacy Act Notification
 
  52.224-2  
April 1984
Privacy Act
 
  52.225-1  
Feb 2009
Buy American Act - Supplies
 
  52.225-13  
Jun 2008
Restrictions on Certain Foreign Purchases
 
  52.227-1  
Dec 2007
Authorization and Consent, Alternate I (Apr 1984)
 
  52.227-2  
Dec 2007
Notice and Assistance Regarding Patent and Copyright Infringement (Over
$100,000)
 
  52.227-11  
Dec 2007
Patent Rights - Ownership by the Contractor
 
  52.227-14  
Dec 2007
Rights in Data - General
 
  52.232-9  
Apr 1984
Limitation on Withholding of Payments
 
  52.232-17  
Oct 2008
Interest (Over $100,000)
 
  52.232-20  
Apr 1984
Limitation of Cost
 
  52.232-23  
Jan 1986
Assignment of Claims
 
  52.232-25  
Oct 2008
Prompt Payment
 
  52.232-33  
Oct 2003
Payment by Electronic Funds Transfer-Central Contractor Registration
 
  52.233-1  
Jul 2002
Disputes
 
  52.233-3  
Aug 1996
Protest After Award, Alternate I (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 2001
Penalties for Unallowable Costs (Over $500,000)
 
  52.242-4  
Jan 1997
Certification of Final Indirect Costs
 
  52.242-13  
Jul 1995
Bankruptcy (Over $100,000)
 
  52.242-15  
Apr 1989
Stop Work Order.  Alt I (Aug 1984)
 
  52.243-2  
Aug 1987
Changes - Cost Reimbursement, Alternate V (Apr 1984)
 
  52.244-2  
June 2007
Subcontracts
 
  52.244-5  
Dec 1996
Competition in Subcontracting (Over $100,000)
 
  52.244-6  
Apr 2010
Subcontracts for Commercial Items
 
  52.245-1  
June 2007
Government Property
 
  52.245-9  
Jun 2007
Use and Charges
 
  52.246-23  
Feb 1997
Limitation of Liability (Over $100,000)
 
  52.249-6  
May 2004
Termination (Cost-Reimbursement)
 
  52-249-14  
Apr 1984
Excusable Delays
 
  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
  352.202-1  
Jan 2006
Definitions - with Alternate paragraph (h) (Jan 2001)
 
  352.216-72  
Jan 2006
Additional Cost Principles
 
  352.228-7  
Dec 1991
Insurance - Liability to Third Persons
 
  352.232-9  
Jan 2006
Withholding of Contract Payments
 
  352.233-70  
Jan 2006
Litigation and Claims
 
  352.242-71  
Apr 1984
Final Decisions on Audit Findings
 
  352.270-5  
Jan 2006
Key Personnel
 
  352.270-4  
Jan.  2001
Pricing of adjustments.
 
  352.270-6  
Jan 2006
Publications and Publicity
 
  352.270-9  
Jan 2006
Care of Live Vertebrate Animals
 
  352.270-10  
Jan 2006
Anti-Lobbying
 

ARTICLE 1.2.  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
 
 
1.
FAR Clause 52.215-17, Waiver of Facilities Capital Cost of Money (October 1997).

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

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

 
b.           DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION
(HHSAR) (48 CHAPTER 3) CLAUSES:
 
 
1.
HHSAR Clause 352.223-70, Safety and Health (January 2006).

 
 
2.
HHSAR Clause 352.224-70, Confidentiality of Information (January 2006).

 
 
3.
HHSAR Clause 352.270-7, Paperwork Reduction Act (January 2006).

 
 
4.
HHSAR Clause 352.270-8 (b), Protection of Human Subjects (January 2006).

 
ARTICLE 1.3.  ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT
 
This contract incorporates the following clauses in full text.
 
FEDERAL ACQUISITION REGULATION (FAR)(48 CFR CHAPTER 1)CLAUSES:
 
a.           FAR Clause 52.219-28, Post-Award Small Business Program
Representation (April 2009).
 
(a)           Definitions.  As used in this clause--
 
Long-term contract means a contract of more than five years in duration,
including options.  However, the term does not include contracts that exceed
five years in duration because the period of performance has been extended for a
cumulative period not to exceed six months under the clause at 52.217-8, Option
to Extend Services, or other appropriate authority.
 
Small business concern means a concern, including its affiliates, that is
independently owned and operated, not dominant in the field of operation in
which it is bidding on Government contracts, and qualified as a small business
under the criteria in 13 CFR part 121 and the size standard in paragraph (c) of
this clause.  Such a concern is “not dominant in its field of operation” when it
does not exercise a controlling or major influence on a national basis in a kind
of business activity in which a number of business concerns are primarily
engaged.  In determining whether dominance exists, consideration shall be given
to all appropriate factors, including volume of business, number of employees,
financial resources, competitive status or position, ownership or control of
materials, processes, patents, license agreements, facilities, sales territory,
and nature of business activity.
 
 
(b)
If the Contractor represented that it was a small business concern prior to
award of this contract, the Contractor shall represent its size status according
to paragraph (e) of this clause or, if applicable, paragraph (g) of this clause,
upon the occurrence of any of the following:

 
(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/contractmgopportiinities/officials/size/index.html.

 
 
(d)
The small business size standard for a Contractor providing a product which it
does not manufacture itself, for a contract other than a construction or service
contract, is 500 employees.

 
 
(e)
Except as provided in paragraph (g) of this clause, the Contractor shall make
the representation required by paragraph (b) of this clause by validating or
updating all its representations in the Online Representations and
Certifications Application and its data in the Central Contractor Registration,
as necessary, to ensure that they reflect the Contractor’s current status.  The
Contractor shall notify the contracting office in writing within the time frames
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 [ ] is, [ ] is not a small business concern
under NAICS Code assigned to contract number.
 
[Contractor to sign and date and insert authorized signer’s name and title].
 
b.           FAR Clause 52.222-39, Notification Of Employee Rights Concerning
Payment Of Union Dues Or Fees (December 2004)
 
(a)           Definition.  As used in this clause –
 
United States means the 50 States, the District of Columbia, Puerto Rico, the
Northern Mariana Islands, American Samoa, Guam, the U.S. Virgin Islands, and
Wake Island.
 
(b)           Except as provided in paragraph (e) of this clause, during the
term of this contract, the Contractor shall post a notice, in the form of a
poster, informing employees of their rights concerning union membership and
payment of union dues and fees, in conspicuous places in and about all its
plants and offices, including all places where notices to employees are
customarily posted.  The notice shall include the following information (except
that the information pertaining to National Labor Relations Board shall not be
included in notices posted in the plants or offices of carriers subject to the
Railway Labor Act, as amended
 
(45 U.S.C. 151-188)).
 
Notice to Employees
 
Under Federal law, employees cannot be required to join a union or maintain
membership in a union in order to retain their jobs.  Under certain conditions,
the law permits a union and an employer to enter into a union-security agreement
requiring employees to pay uniform periodic dues and initiation fees.  However,
employees who are not union members can object to the use of their payments for
certain purposes and can only be required to pay their share of union costs
relating to collective bargaining, contract administration, and grievance
adjustment.
 
If you do not want to pay that portion of dues or fees used to support
activities not related to collective bargaining, contract administration, or
grievance adjustment, you are entitled to an appropriate reduction in your
payment.  If you believe that you have been required to pay dues or fees used in
part to support activities not related to collective bargaining, contract
administration, or grievance adjustment, you may be entitled to a refund and to
an appropriate reduction in future payments.
 
For further information concerning your rights, you may wish to contact the
National Labor Relations Board (NLRB) either at one of its Regional offices or
at the following address or toll free number:
 
National Labor Relations Board
 
Division of Information
 
1099 14th Street, N.W
 
Washington, DC 20570
 
1-866-667-6572
 
1-866-316-6572 (TTY)
 
To locate the nearest NLRB office, see NLRB’s website at http://www.nlrb.gov .
 
(c)           The Contractor shall comply with all provisions of Executive Order
13201 of February 17, 2001, and related implementing regulations at 29 CFR part
470, and orders of the Secretary of Labor.
 
(d)           In the event that the Contractor does not comply with any of the
requirements set forth in paragraphs (b), (c), or (g), the Secretary may direct
that this contract be cancelled, terminated, or suspended in whole or in part,
and declare the Contractor ineligible for further Government contracts in
accordance with procedures at 29 CFR part 470, Subpart B -- Compliance
Evaluations, Complaint Investigations and Enforcement Procedures.  Such other
sanctions or remedies may be imposed as are provided by 29 CFR part 470, which
implements Executive Order 13201, or as are otherwise provided by law.
 
(e)           The requirement to post the employee notice in paragraph (b) does
not apply to –
 
(l)           Contractors and subcontractors that employ fewer than 15 persons;
 
(2)           Contractor establishments or construction work sites where no
union has been formally recognized by the Contractor or certified as the
exclusive bargaining representative of the Contractor’s employees;
 
(3)           Contractor establishments or construction work sites located in a
jurisdiction named in the definition of the United States in which the law of
that jurisdiction forbids enforcement of union-security agreements;
 
(4)           Contractor facilities where upon the written request of the
Contractor, the Department of Labor Deputy Assistant Secretary for
Labor-Management Programs has waived the posting requirements with respect to
any of the Contractor’s facilities if the Deputy Assistant Secretary finds that
the Contractor has demonstrated that--
 
(i)           The facility is in all respects separate and distinct from
activities of the Contractor related to the performance of a contract; and
 
(ii)           Such a waiver will not interfere with or impede the effectuation
of the Executive order; or
 
(5)           Work outside the United States that does not involve the
recruitment or employment of workers within the United States.
 
(f)           The Department of Labor publishes the official employee notice in
two variations; one for Contractors covered by the Railway Labor Act and a
second for all other Contractors.  The Contractor shall--
 
(1)           Obtain the required employee notice poster from the Division of
Interpretations and Standards, Office of Labor-Management Standards, U.S.
Department of Labor, 200 Constitution Avenue, NW, Room N-5605, Washington, DC
2021, or from any field office of the Department’s Office of
Labor-Management  Standards or Office of Federal Contract Compliance Programs;
 
(2)           Download a copy of the poster from the Office of Labor-Management
Standards website at http://www.olms.dol.gov ; or
 
(3)           Reproduce and use exact duplicate copies of the Department of
Labor’s official poster.
 
(g)           The Contractor shall include the substance of this clause in every
subcontract or purchase order that exceeds the simplified acquisition threshold,
entered into in connection with this contract, unless exempted by the Department
of Labor Deputy Assistant Secretary for Labor-Management Programs on account of
special  circumstances  in the  national  interest under  authority of 29  CFR
470.3(c).  For indefinite quantity subcontracts, the Contractor shall include
the substance of this clause if the value of orders in any calendar year of the
subcontract is expected to exceed the simplified acquisition
threshold.  Pursuant to 29 CFR part 470, Subpart B--Compliance Evaluations,
Complaint Investigations and Enforcement Procedures, the Secretary of Labor may
direct the Contractor to take such action in the enforcement of these
regulations, including the imposition of sanctions for noncompliance with
respect to any such subcontract or purchase order.  If the Contractor becomes
involved in litigation with a subcontractor or vendor, or is threatened with
such involvement, as a result of such direction, the Contractor may request the
United States, through the Secretary of Labor, to enter into such litigation to
protect the interests of the United States.  (End of Clause)
 

-  -

 
 

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

 

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS
 
SECTION J - LIST OF ATTACHMENTS
 
The following documents are attached and incorporated in this contract:
 
1.           Statement of Work
 
Statement of Work, dated 5 May 2010.
 
2.           Invoice/Financing Request Instructions and Contract Financial
Reporting Instructions for BARD A Cost- Reimbursement Type Contracts,
 
Invoice/Financing Request Instructions and Contract Financial Reporting
Instructions for BARDA Cost-Reimbursement Type Contracts, 5 pages.
 
3.           Financial Report of Individual Project/Contract, 1 page
 
4.           Instructions for Completing Financial Report of Individual
Project/Contract, 3 pages
 
5.           Inclusion Enrollment Report
 
Inclusion Enrollment Report, 5/01 (Modified OAMP: 10/01), 1 page.
 
6.           Research Patient Care Costs Research Patient Care Costs, 1 page.
 
7.           Report of Government Owned, Contractor Held Property
 
Report of Government Owned, Contractor Held Property, dated 12/2/09, 1
page.  Located at: http://rcb.cancer.gov/rcb-iuternet/lbrms/Govt-Owned-Prop.pdf
(Not Attached)
 
8.           Small Business Subcontracting Plan
 
Small Business Subcontracting Plan, dated 5 May 2010.
 

-  -

 
 

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

 

PART IV -  REPRESENTATIONS AND INSTRUCTIONS
 
SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS
 
The following documents are incorporated by reference in this contract:
 
1)
Annual Representations and Certifications completed at the Online
Representations Applications (ORCA) website.

 
2)
Representations & Certifications dated 5 May 2010.

 
3)
Human Subjects Assurance Identification Number FSW00007296, Type F

 
4)
Animal Welfare Assurance Number A3034-01

 

-  -

 
 

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

 

 

 
 

 
 
ATTACHMENT 1 - Statement of Work, dated 5 May 2010.
 
 

 
 
1 of 14 Pages.
 

 
 

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

 

3.0
STATEMENT OF WORK BROAD AGENCY ANNOUNCEMENT (BAA)

 
 
BARDA 09-34

 
Advanced Research and Development of Chemical, Biological, Radiological, and
Nuclear Medical Countermeasures Statement of Work
 
Development of a Large-Scale Manufacturing Process for BioThrax Preamble
 
(TG2) Independently and not as an agent of the Government, the Contractor shall
be required to furnish all the necessary services, qualified personnel,
material, equipment, and facilities, not otherwise provided by the Government,
as needed to perform the Statement of Work (SOW) submitted in response to Broad
Agency Announcement (BAA) BARDA 09-34.
 
The Government reserves the right to modify the milestones, progress, schedule,
budget, or product to add or delete products, process, or schedule as need may
arise.  Because of the nature of the (R&D) contract and complexities inherent in
this and prior programs, at designated milestones the government will evaluate
whether work should be redirected, removed, or whether schedule or budget
adjustments should be made.  In any event the Government reserves the right to
change product, process, schedule, or event to add or delete part or all of
these elements as the need arises.
 
1.0 SCOPE
 
The scope of work for this contract includes development activities that fall
into the following areas: process and assay development, qualification and
validation, manufacturing, clinical, animal study, and all other BLA-enabling
activities.
 
2.0 OBJECTIVE
 
The objective of this SOW is to license Building  55 on Emergent BioDefense
 
Operations  Lansing Inc.’s campus for large-scale manufacturing of BioThrax.
 
3.0 TECHNICAL APPROACH
 
This section identifies representative tasks and sub-tasks for achieving the
objective.  We organize tasks and subtasks by year, Figure 27.
 
SOW Task #
WBS#
Base
Years
Opt.
Yr1
Opt.
Yr2
Opt.
Yr3
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]

Figure 27.  We organized the representative tasks and sub-tasks of the SOW by
the years in which they will occur.
3.1           (WBS [**]) Development Approach:
 
3.1.1           (WBS [**]) Non-Clinical Research and Development
 
Non-clinical activities delineated in the Integrated Product Development Plan
include:
 
3.1.1.1                      (WBS [**]
 
Evaluate [**]
 
3.1.1.2                      (WBS [**]
 
Evaluate [**].
 
3.1.1.3                      (WBS [**]
 
Evaluate [**].
 
Additional non-clinical activities required for licensure of BioThrax in
Building 55 may be identified in the course of development.
 
Studies evaluating the safety, comparability, immunogenicity, toxicity,
efficacy, formulation, dose, route and schedule of BioThrax using both in vitro
and animal models following Good Laboratory Practice guidelines (GLP: as defined
in the U.S. Code of Federal Regulations 21 CFR Part §58) may need to be
conducted as and when appropriate to achieve the contract objective.
 
3.1.2           (WBS [**]) Development
 
Activities delineated in the Integrated Product Development Plan include:
 
3.1.2.1                      (WBS [**]) Process Development and Validation
 
3.1.2.2                      (WBS [**]) Assay Development and Validation
 
3.1.2.2.1                      (WBS [**]
 
–  
[**]

 
3.1.2.2.2                      (WBS [**]
 
–  
[**]

 
3.1.2.2.3                      [**]
 
3.1.2.2.4                                (WBS [**]
 
3.1.2.2.5                                           [**]
3.1.2.3.1                                (WBS [**]
 
–  
[**]

 
3.1.2.3.2                      (WBS  [**]
 
–  
[**]

 
3.1.2.3.3                      (WBS [**]
 
–  
[**]

3.1.2.3.4      (WBS [**]
 
–  
[**]

 
3.1.2.4 (WBS [**]
 
3.1.2.4.1 (WBS [**]
 
–  
[**]

 
3.1.2.4.2                      (WBS [**]
 
–  
[**]

 
3.1.2.4.3                      (WBS [**]
 
–  
[**]

 
Additional process development, formulation and manufacturing development
studies may be identified in the course of development to meet the requirements
for FDA licensure of BioThrax in Building 55.
 
3.1.3           (WBS [**]) Clinical Development
 
Activities include:
 
3.1.3.1                      (WBS [**]
 
In accordance with all Federal regulations and GCP guidelines as required for
BioThrax licensure in Building 55.  [**]
 
[**]
 
Additional requirements [**] may be identified in the course of development to
meet the requirements for FDA licensure of BioThrax in Building 55.
 
3.1.4           (WBS [**]) Regulatory Affairs Management
 
Activities delineated in the Integrated Product Development Plan include:
 
[**]
 
An EVM System shall be implemented within days of contract award to meet the
requirements of a Tier 2 EVM implementation as outlined in the BARDA Tier 2 EVM
System Implementation Intent Guide.
 
For the purposes of this contract, EBOL shall use EVMS in the management of this
contract to meet the Seven Principles of Earned Value Management as follows:
 
a)           Plan all work scope for the program to completion.
 
b)           Break down the program work scope into finite pieces that can be as
signed to a responsible person or organization for control of technical,
schedule, and cost objectives.
 
c)           Integrate program work scope, schedule, and cost objectives into a
performance measurement  baseline  plan against which accomplishments may be
measured.  Control Changes to the base line.
 
d)           Use actual cost incurred and re corded in accomplishing the work
per formed.
 
e)           Objectively assess accomplishments at the work performance level.
 
f)           Analyze significant variances from the plan, forecast impacts, and
prepare an estimate at completion based on performance to date and work to be
performed..
 
g)           Use earned value information in the company’s management processes
specific to this contract.
 
EVMS shall be applied to CLIN [**] as part of the Integrated Master Project
Plan, EBOL shall submit a written summary of the management procedures that it
will establish, maintain and use to comply with EVMS requirements.
 
3.2.2           Integrated Product Development Plan (IPDP)
 
The IPDP shall contain the following elements:
 
a)           Activities and stages of product development that Emergent is
proposing to per-form under contract funding in a project plan that indicates
the base period and option period activities and includes all of the functional
areas of development listed below.
 
b)           A detailed description of the experimental design, including the
rationale for experimental approaches, and a description of alternative
approaches to be employed if these methods do not achieve the defined goals.
 
c)           Distinct stages of the product development pathway that are gates
for Go/No Go decisions for advancing to the next stage of the IPDP.
 
d)           The qualitative and quantitative criteria and accompanying data
used to assess the scientific merit and technical feasibility of proceeding to
the next stage of product development.
 
e)           Milestones and timelines for the initiation, conduct, and
completion of product development activities for each stage with a budget (in
direct costs) linked to each stage.
 
f)           A listing of key personnel (including proposed consultants) who
possess the necessary education, training, and experience to successfully
perform the work identified in the technical proposal and their resumes.
 
g)           A staffing plan that indicates personnel (in house and contracted)
resources and the percentage of time to be dedicated to perform the work.
 
h)           A clear and comprehensive regulatory master plan that focuses on
the crucial pathway integrating all products, risk evaluation and mitigation at
all development stages, non-clinical and clinical testing, manufacturing
activities using the most current and available information, and documented and
time-relevant FDA consultation.
 
i)           Establishment and filing of regulatory submissions to the relevant
FDA center.
 
j)           A plan for additional studies to support future filing for
FDA-approval/ clearance.
 
k)           Summary of any prior communication with the FDA relevant to the
product development; summary of audits and inspections.
 
l)           Tentative schedule of regulatory milestones.
 
m)           Potential Plan for consideration of an Emergency Use Authorization
(EUA) of a medical product.
 
n)           A work breakdown structure (WBS) that is discernable and
consistent.  It may include data at the cost account level or at the work
package level or at a lower level if there is significant complexity and risk
associated with the task.
 
o)           An approach for tracking milestones, costs, risks, subcontractor
effort (if applicable), deliverables and proposed internal procedures for
assuring timely responses to the Government’s needs on any resulting contract.
 
p)           An approach for performance measurement that shall include
establishing an initial plan; defining measurable parameters; defining how these
parameters relate to cost and schedule impacts; their approach in providing a
detailed schedule that generates a critical path for the project; and a
description of the cost-accounting system used or intended to be used based on
budget estimates to monitor all costs related to the contract award for both
prime- and sub-contractors on a real time basis.
 
q)           A table matrix capturing all program activities that will generate
data and the documents that will be generated from each activity.
 
3.2.1.1                      Updated IPDP
 
Within fourteen (14) days of the effective date of the BAA award and prior to
the contract kickoff meeting, which will occur within thirty (30) days of the
effective date of the BAA award, EBOL shall submit an updated draft IPDP which
shall be approved by the Project Officer and the Contracting Officer prior to
initiation of any activities related to their implementation.  The final IPDP is
due within ten (10) days of the contract kickoff meeting.  During the course of
contract performance, in response to a need to change the IPDP,
 
Emergent shall submit a Deviation Report.  This report shall request a change in
the agreed-upon Plan and timelines.  This report shall include:
 
a)           Discussion of the justification/ rationale for the proposed change.
 
b)           Options for addressing the needed changes from the approved
timelines, including a cost-benefit analysis of each option.
 
c)           Recommendations for the preferred option that includes a full
analysis and discussion of the effect of the change on the entire product
development pro gram, timelines, and budget.
 
d)           Emergent shall carry out activities within the contract SOW only as
requested and approved by the Contracting Officer, and may not conduct work on
the contract without prior approval from the Contracting Officer, including
initiating work that deviates from the agreed-upon IPDP.
 
3.2.2           Target Product Profile (TPP):
 
a)           The intended use or indication of the proposed medical
countermeasure.
 
b)           The intended product profile (strength, quality, purity and
identity) noting the performance specifications and features of the medical
countermeasure that provide benefit.
 
c)           A description of the medical counter measure as it is currently
configured.
 
d)           A description of the manufacturing process including expected
formulation (configuration) of the final product.
 
e)           A description and developmental status of the assays for product
release which provide characterization, strength, identity, and purity, as well
as any needed assays for product activity and efficacy.
 
f)           Discussions with appropriate FDA reviewers that is relevant to
development activities for the proposed medical countermeasure, including plans
for generating data to support an  Investigational New
 
Drug (IND) or Biologies License Application (BLA): summary of any prior,
time-relevant communication with FDA relevant to the product development for the
indication noted; summary of audits and inspections relative to the current
development or proposed manufacturing (including at key sub-contractors) of the
intended product.
 
3.2.3           Contractor Provided Facilities, Infrastructure, and Other
Resources
 
This includes but is not limited to:
 
a)           Current facility design including quality control labs for testing
and release, laboratory areas  supporting formulation and assay development,
manufacturing process flow, and animal studies.
 
b)           Major equipment and layout (preliminary  piping/  instrumentation
drawing).
 
c)           Validation master plan for key equipment, analytical methods and
manufacturing process.
 
3.2.4           Security Plan
 
This includes but is not limited to:
 
a)           Security administration, as an element of the security program that
address threat and risk assessments and related policies and procedures for
personnel security, physical security,  information security, information
technology.
 
b)           Security management, as an element of the security program that de
scribe each element of security: physical, operations, personnel, information,
information technology, transportation; and related  training, auditing, and
reporting requirements.
 
3.2.5           (WBS [**]
 
[**]

Contract Period
MSTN #
Milestones
Deliverables Summary (Details as specified in the Deliverable section)
Quantity
Date
Base
01
[**]
[**]
1 Electronic Copy Project Officer (PO) 1 Hard Copy - PO 1 Electronic Copy
-Contracting Officer (CO) 1 Hard Copy - CO
[**]
02
[**]
[**]
see above
[**]
Base
03
[**]
[**]
see above
[**]
04
[**]
[**]
see above
[**]
05
[**]
[**]
see above
[**]
06
[**]
[**]
see above
[**]
07
[**]
[**]
see above
[**]
08
[**]
[**]
see above
[**]
Option Year 1
09
[**]
[**]
see above
[**]
10
[**]
[**]
see above
[**]
Option Year 2
 
11
[**]
[**]
see above
[**]
12
[**]
[**]
see above
[**]
13
[**]
[**]
see above
[**]
14
[**]
[**]
see above
[**]
Option Year 3
15
[**]
[**]
see above
[**]
16
[**]
[**]
see above
[**]
17
[**]
[**]
see above
[**]
18
[**]
[**]
see above
[**]

 
MSTN #
Milestones
Deliverables Summary (Details as specified in the Deliverable section)
Quantity
Date
[**]
Option
 
01
[**]
[**]
1 Electronic Copy Project Officer (PO) 1 Hard Copy - PO 1 Electronic Copy
-Contracting Officer (CO) 1 Hard Copy - CO
[**]
02
[**]
[**]
see above
[**]
03
[**]
[**]
see above
[**]

 
 

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

 

CDRL#
Deliverable
Deliverable Description
Quantity
Due Date
 
01
Kickoff Meeting/Status Update Meetings
The contractor shall complete a Kickoff meeting after contract award and shall
hold recurring Program Review Meetings.
N/A
Within a month of contract award, but after submission of a draft PDP, for Kick
Off meeting (Final IPDP revision to be submitted per Deliverable #9).  Program
Review Meetings shall occur semi-annually or as negotiated by all Parties during
contract period of Performance.
 
02
Biweekly Teleconference
The Contractor shall participate in biweekly teleconferences with BARDA to
discuss the performance of the contract.  The Contractor shall record, maintain
and provide draft meeting minutes to the Project Officer for approval within
three (3) days after teleconference.  The Project Officer will approve the draft
version within two (2) business days after receipt.  The Contractor shall
distribute the final approved version duly marked as final within 3 business
days after receipt of BARDA approval.
1 Electronic Copy Project Officer (PO) 1 Electronic Copy -Contracting Officer
(CO)
Biweekly or as negotiated by all parties
 
03
Monthly & Annual Technical Progress Report
The Monthly and Annual Technical Progress report shall address each of the below
items and be cross-referenced to the WBS in the Gantt chart and IPDP.
1.  An Executive Summary in MS PowerPoint format, highlighting the progress,
issues, and relevant activities in manufacturing, non-clinical, clinical, and
regulatory.  The Executive Summary should be limited to a few slides and also
highlight only critical issues for that reporting period and resolution approach
2.  Progress in meeting contract milestones - broken out by subtasks within each
milestone, overall project assessment, problems encountered and recommended
solutions.  The reports shall detail the planned progress and actual progress
during the period covered, explaining occurrences of any differences between the
two, and the corrective steps and actions are planned, if behind schedule.
3.  The reports shall also include a three month rolling forecast of key planned
activities, referencing the WBS/IPDP.
4.  A tracking log of progress on regulatory submissions with the FDA submission
number, description of submission, date of submission, status of submission, and
next steps
5.  Estimated and Actual Expenses a.  This report shall also contain a narrative
statement as to whether there is any discrepancy at this time between the % of
work completed and the cumulative costs incurred to date.  This section of the
report shall also contain estimates for the Subcontractors’ expenses from the
previous month if the Subcontractor did not submit a bill in the previous
month.  These shall be listed for each subcontractor.  If the subcontractor(s)
was not working or did not incur any costs in the previous month, then a
statement to this effect should be included in this report for those respective
subcontractors.
1 Electronic Copy Project Officer (PO) 1 Hard Copy - PO 1 Electronic Copy —
Contracting Officer (CO) 1 Hard Copy - CO
Monthly Reports shall be submitted on the 15th day of each month for the
previous calender month with an Annual Report submitted on the 15th day of the
final month of each contract year for the previous twelve calender
months.  Monthly progress reports are not required for the periods when the
Annual Report(s) and Final Report is due.
 
04
Technical Documents
The contractor shall provide complete technical documents for BARDA review and
approval.  All documents shall be duly marked as either ‘Draft’ or
‘Final’.  These technical documents shall include, but shall not be limited to,
the following: [**]
For Draft Documents: 1 Electronic Copy Project Officer (PO) 1 Electronic Copy
-Contracting Officer (CO)
For Final Documents: 1 Electronic Copy Project Officer (PO) 1 Hard Copy - PO 1
Electronic Copy — Contracting Officer (CO) 1 Hard Copy - CO
Draft documents shall be submitted to BARDA for review and comment.  BARDA will
provide feedback within 5 business days.  Contractor shall submit all final
technical documents within 5 calendar days of completion or as mutually agreed
to during the program execution with the Project Officer.
 
05
Draft Final Contract Report
A draft Final Contract Report containing a summation of the work performed and
the results obtained for the entire contract period of performance.  The draft
report shall be duly marked as ‘Draft’.
1 Electronic Copy Project Officer (PO) 1 Hard Copy - PO 1 Electronic Copy
-Contracting Officer (CO) 1 Hard Copy - CO
Due 90 days prior to the completion date of the contract.
 
06
Final Contract Report
The Final Contract Report incorporating the feedback received from BARDA and
containing a summation of the work performed and the results obtained for the
entire contract period of performance.  The final report shall be duly marked as
‘Final’.  The Contractor shall submit one (1) copy of a comprehensive final
report to the Contracting Officer and two (2) copies (one electronically on a
CD) to the Project Officer.  This final report shall detail, document and
summarize the results of the entire contract work for the period covered.  This
report shall be in sufficient detail to explain comprehensively the results
achieved under all milestones.
see above
Due on/before the completion of the contract
 
07
Milestone Reports
The Contractor shall provide a Milestone Report with final versions of key
project documentation, after the completion of each Milestone unless otherwise
agreed upon by the Project Officer and the Contracting Officer.  All documents
related to Milestone deliverables shall be submitted to BARDA in draft form for
review and comments prior to submittal in final form in the final Milestone
Report.  All documents shall be duly marked as either ‘Draft’ or
‘Final’.  Milestone reports and monthly reports may be combined if agreed by the
Project Officer and the Contracting Officer
see above
Draft Milestone report shall be submitted within 15 calendar days after
completion of Milestone.  3ARDA will provide comments on :he Draft Milestone
Report within 5 business days after receipt.  Final Milestone Report shall be
submitted within 15 calender days from receipt of BARDA comments.
 
08
Standard Operating Procedures
The contractor shall make internal and subcontractor Standard Operating
Procedures (SOPs) available for review electronically.
N/A
Upon request from the project officer/contracting officer
 
09
IPDP
The Contractor shall be required to update the IPDP and include within the IPDP
a table matrix capturing all program activities that will generate data and the
documents that will be generated from each activity.  In response to a need to
change the IPDP, the contractor shall provide a deviation report identifying the
reason for the deviation and request for change in the agreed upon plan and
timelines.
1 Electronic Copy Project Officer (PO) 1 Hard Copy - PO 1 Electronic Copy
-Contracting Officer (CO) 1 Hard Copy - CO
Within 10 business days after the contract kick off meeting and following any
revisions to the IPDP that occur during the contract Period of Performance.  A
deviation report shall be submitted as soon as the Contractor has sufficient
data to support the need for a change from the approved IPDP.
 
10
FDA Correspondence and Mtgs Summaries
The contractor shall forward initial contractor and CBER-issued draft minutes
and final minutes of any meeting with the FDA to BARDA.  All documents shall be
duly marked as either ‘Draft’ or ‘Final’.
see above
Within 5 business days of each meeting for contractor’s minutes and upon receipt
of minutes from CBER
 
11
FDA Meetings
The contractor shall forward the dates and times of any meeting with the FDA to
BARDA and make arrangements for appropriate BARDA staff to attend the FDA
meetings.  BARDA staff shall include up to a maximum of four people (Project
Officer, Contracting Officer, and up to 2 subject matter experts).
N/A
As and when scheduled during the contract period of performance
 
12
FDA Submissions
The contractor shall provide BARDA the opportunity to review and comment upon
all draft regulatory documents before submission to the FDA.  Contractor shall
provide BARDA with an electronic copy of the final FDA submission.  All
documents shall be duly marked as either ‘Draff or ‘Final’.
1 Electronic Copy Project Officer (PO) 1 Electronic Copy -Contracting Officer
(CO)
BARDA shall provide comment within 10 business days after receipt.  BARDA
reserves the right to request more than 10 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 10 business days will be needed to complete its
review of the document.
Final FDA submissions shall be submitted to BARDA concurrently or no later than
1 calendar day of its submission to CBER.
 
13
FDA Audits
The Contractor shall notify the Project Officer and Contracting Officer within
24 hours of all FDA’s arrival to conduct site visits/audits by any regulatory
agency.  In the event of an FDA inspection which occurs as a result of this
contract and for this product, or for any other FDA inspection that has the
reasonable potential to impact the performance of this contract, the Contractor
shall provide the USG with an exact copy (non-redacted; of the FDA Form 483, and
the Establishment Inspection Report (EIR).  The contractor shall provide the
Project Officer and Contracting Officer copies of the plan for addressing areas
of non-conformance to FDA regulations for GLP, GMP, or GCP guidelines as
identified in the audit report, status updates during the plans execution, and a
copy of all final responses to the FDA.  The Contractor shall also provide
redacted copies of any FDA audits received from subcontractors that occur as a
result of this contract or for this product.  The contractor shall make
arrangements for BARDA representative(s) to be present during the final debrief
by the regulatory inspector.
1 Electronic Copy Project Officer (PO) 1 Hard Copy - PO 1 Electronic Copy
-Contracting Officer (CO) 1 Hard Copy - CO
Within 24 hours of receipt from Regulatory Agency or Subcontractor.
14
Contractor Audit/Site Visits
The contractor shall inform the Project Officer and Contracting Officer in
advance of upcoming audits/site visits of subcontractors as part of the biweekly
communications, including goals and agenda.  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, details 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
1 Electronic Copy Project Officer (PO) 1 Electronic Copy — Contracting Officer
(CO)
Within 5 business days of report completion.
15
Publications
Any manuscript or scientific meeting abstract containing data generated under
this contract must be submitted to BARDA for review prior to submission
see above
Within 30 calendar days for manuscripts and 15 calendar days for abstracts
16
Press Releases
The contractor agrees to accurately and factually represent the work conducted
under this contract in all press releases
1 Electronic Copy -Contracting Officer (CO)
The contractor shall ensure that the Contracting Officer has received and
approved an advanced copy of any press release to this contract not less than 4
business days prior to the issuance of the press release
17
Security Reporting
The contractor shall report to the government any activity or incident that is
in violation of established security standards or indicates the loss or theft of
government products
1 Electronic Copy Project Officer (PO) 1 Electronic Copy -Contracting Officer
(CO)
within 24 hours after occurrence of activity or incident
18
Contract Performance report Format 1
A monthly Contract Performance Report Format at an agreed upon reporting level
using the BARDA provided Work Breakdown Structure
see above
Due 20 days after the end of the Emergent Accounting Calendar
19
Format 5 Variance Analysis Report
A Format 5 Variance Analysis Report for each WBS reporting level that exceeds
the agreed upon variance reporting threshold
see above
Due 20 days after the month-end of the Emergent accounting calendar
20
Program
Integrated Master Schedule
A program Integrated Master Schedule with monthly status updates (e.g.  %
complete for program tasks)
 
see above
 
Initial IMS due 30 days after award.  Monthly status updates are due 10 days
after the month-end of the Emergent accounting calendar
 
21
Performance Measure Baseline
Provide EVM documentation to BARDA, providing proof of a Performance Measurement
Baseline 90 days after contract award.  This submission EVM documentation shall
include: a description of the work scope through control account Work
Authorization Documents (WADs); Integrated Master Schedule (IMS) with the
inclusion of agreed major milestones and control account plans (CAP) for all
control accounts; baseline revision documentation and program logs (s) risk
register.  BARDA will review documentation and provide written comments and
questions to Contractor.  A follow-on meeting or telecom will be scheduled no
later than 10 business days after receipt from BARDA
Electronic Copy of Project Officer (PO) 1 Hard Copy - PO 1 Electronic Copy
-Contracting Officer (CO) 1 Hard Copy - CO
Due 90 days after contract award.  BARDA will provide comments to the draft no
later than 20 business days.  Final Performance Measurement Baseline due to
BARDA 10 business days following follow-on meeting or telecon.
 

 
 

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

 

ATTACHMENT 2
 
INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORTING
 
INSTRUCTIONS FOR BARDA 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 G of the Contract Schedule.
 
Frequency:  Payment requests shall not be submitted more frequently than once
every two weeks in accordance with the Allowable Cost and Payment Clause
incorporated into this contract.  Small business concerns may submit
invoices/financing requests more frequently than every two weeks when authorized
by the Contracting Officer.
 
Cost Incurrence Period:  Costs incurred must be within the contract performance
period or covered by precontract cost provisions.
 
Billing of Costs Incurred:  If billed costs include (1) costs of a prior billing
period, but not previously billed, or (2) costs incurred during the contract
period and claimed after the contract period has expired, the Contractor shall
site the amount(s) and month(s) in which it incurred such costs.
 
Contractor’s Fiscal Year:  Payment requests shall be prepared in such a manner
that the Government can identify costs claimed with the Contractor’s fiscal
year.
 
Currency:  All BARDA contracts are expressed in United States dollars.  When the
Government pays in a currency other than United States dollars, billings shall
be expressed, and payment by the Government shall be made, in that other
currency at amounts coincident with actual costs incurred.  Currency
fluctuations may not be a basis of gain or loss to the
Contractor.  Notwithstanding the above, the total of all invoices paid under
this contract may not exceed the United States dollars authorized.
 
Costs Requiring Prior Approval:  Costs requiring the Contracting Officer’s
approval, which are not set forth in an Advance Understanding in the contract,
shall be identified and reference the Contracting Officer’s Authorization (COA)
Number.  In addition, the Contractor shall show any cost set forth in an Advance
Understanding as a separate line item on the payment request.
 
Invoice/Financing Request Identification: Each payment request shall be
identified as either.
 
(a)
Interim Invoice/Contract Financing Request:  These are interim payment requests
submitted during the contract performance period.

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

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

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

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

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

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

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

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

 
(g)
Total Estimated Cost of Contract/Order:  Insert the total estimated cost of the
contract, exclusive of fixed-fee.  If billing under an order, insert the total
estimated cost of the order, exclusive of fixed-fee.  For incrementally funded
contracts/orders, enter the amount currently obligated and available for
payment.

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

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

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

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

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

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

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

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

 
 
(1)
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.)
 
(2)
Fringe Benefits:  List any fringe benefits applicable to direct labor and billed
as a direct cost.  Do not include in this category fringe benefits that are
included in indirect cost.

 
 
(3)
Accountable Personal Property:  Include permanent research equipment and general
purpose equipment having a unit acquisition cost of $1,000 or more, with a life
expectancy of more than two years, and sensitive property regardless of cost
(see the HHS Contractor’s Guide for Control of Government Property).  Show
permanent research equipment separate from general purpose equipment.

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

 
-           item number for the specific piece of equipment listed in the
Property Schedule, and
 
-           COA number, if the equipment is not covered by the Property
Schedule.
 
The Contracting Officer may require the Contractor to provide further
itemization of property having specific limitations set forth in the contract.
 
 
(4)
Materials and Supplies: Include equipment with unit costs of less than $1,000 or
an expected service life of two years or less, and consumable material and
supplies regardless of amount.

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

 
 
(6)
Consultant Fee: List fees paid to consultants.  Identify consultant by name or
category as set forth in the contract or COA, as well as the effort (i.e.,
number of hours, days, etc.) and rate billed.

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

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

 
 
(9)
Other: List all other direct costs in total unless exceeding $1,000 in
amount.  If over $1,000, list cost elements and dollar amounts separately.  If
the contract contains restrictions on any cost element, that cost element must
be listed separately.

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

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

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

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

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

 
(u)
Grand Totals

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

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

 
The Contracting Officer may require the Contractor to submit detailed support
for costs claimed on one or more interim payment requests.
 
FINANCIAL REPORTING INSTRUCTIONS:
 
These instructions are keyed to the Columns on the sample invoice/financing
request.
 
Column A - Expenditure Category:  Enter the expenditure categories required by
the contract.
 
Column B - Cumulative Percentage of Effort/Hrs.  - Negotiated:  Enter the
percentage of effort or number of hours agreed to for each employee or labor
category listed in Column A.
 
Column C - Cumulative Percentage of Effort/Hrs.  - Actual:  Enter the percentage
of effort or number of hours worked by each employee or labor category listed in
Column A.
 
Column D - Amount Billed - Current:  Enter amounts billed during the current
period.  Column E - Amount Billed - Cumulative: Enter the cumulative amounts to
date.
 
Column F - Cost at Completion:  Enter data only when the Contractor estimates
that a particular expenditure category will vary from the amount
negotiated.  Realistic estimates are essential.
 
Column G - Contract Amount:  Enter the costs agreed to for all expenditure
categories listed in Column A.
 
Column H - Variance (Over or Under):  Show the difference between the estimated
costs at completion (Column F) and negotiated costs (Column G) when entries have
been made in Column F.  This column need not be filled in when Column F is
blank.  When a line item varies by plus or minus 10 percent, i.e., the
percentage arrived at by dividing Column F by Column G, an explanation of the
variance should be submitted.  In the case of an overrun (net negative
variance), this submission shall not be deemed as notice under the Limitation of
Cost (Funds) Clause of the contract.
 
Modifications:  Any modification in the amount negotiated for an item since the
preceding report should be listed in the appropriate cost category.
 
Expenditures Not Negotiated:  An expenditure for an item for which no amount was
negotiated (e.g., at the discretion of the Contractor in performance of its
contract) should be listed in the appropriate cost category and all columns
filled in, except for G.  Column H will of course show a 100 percent variance
and will be explained along with those identified under H above.
 

 
 

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

 

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

 
 

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

 

ATTACHMENT 3
 

FINANCIAL REPORT OF INDIVIDUAL
PROJECT/CONTRACT
 
Note: Complete this Form in Accordance with
Accompanying Instructions.
 
Project Task:
Contract No.:
Date of Report:
0990-0134
0990-0131
Reporting Period:
Contractor Name and Address:
Expenditure Category
Percentage of Effort/Hours
Cumulative Incurred Cost at End of Prior Period
Incurred Cost-Current 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
1
J
                                                                               
                                                                               
                                                                               
                                                                               

 
 

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

 

ATTACHMENT 4
 
INSTRUCTIONS FOR COMPLETING “FINANCIAL REPORT OF INDIVIDUAL PROJECT/CONTRACT”
 
GENERAL INFORMATION
 
Purpose.  This Quarterly Financial Report is designed to: (1) provide a
management tool for use by be BARDA in monitoring the application of financial
and personnel resources to the BARDA contracts; (2) provide contractors with
financial and personnel management data which is usable in their management
processes; (3) promptly indicate potential areas of contract underruns or
overruns by making possible comparisons of actual performance and projections
with prior estimates on individual elements of cost and personnel; and (4)
obtain contractor’s analyses of cause and effect of significant variations
between actual and prior estimates of financial and personnel performance.
 
REPORTING REQUIREMENTS
 
Scope.  The specific cost and personnel elements to be reported shall be
established by mutual agreement prior to award.  The Government may require the
contractor to provide detailed documentation to support any element(s) on one or
more financial reports.
 
Number of Copies and Mailing Address.  An original and two (2) copies of the
report(s) shall be sent to the contracting officer at the address shown on the
face page of the contract, no later than 30 working days after the end of the
period reported.  However, the contract may provide for one of the copies to be
sent directly to the Contracting Officer’s Technical Representative.
 
REPORTING STATISTICS
 
A modification which extends the period of performance of an existing contract
will not require reporting on a separate quarterly report, except where it is
determined by the contracting officer that separate reporting is
necessary.  Furthermore, when incrementally funded contracts are involved, each
separate allotment is not considered a separate contract entity (only a funding
action).  Therefore, the statistics under incrementally funded contracts should
be reported cumulatively from the inception of the contract through completion.
 
Definitions and Instructions for Completing the Quarterly Report.  For the
purpose of establishing expenditure categories in Column A, the following
definitions and instructions will be utilized.  Each contract will specify the
categories to be reported.
 
(1)           Key Personnel.  Include key personnel regardless of annual salary
rates.  All such individuals should be listed by names and job titles on a
separate line including those whose salary is not directly charged to the
contract but whose effort is directly associated with the contract.  The listing
must be kept up to date.
 
(2)           Personnel-Other.  List as one amount unless otherwise required by
the contract.
 
(3)           Fringe Benefits.  Include allowances and services provided by the
contractor to employees as compensation in addition to regular salaries and
wages.  If a fringe benefit rate(s) has been established, identify the base,
rate, and amount billed for each category.  If a rate has not been established,
the various fringe benefit costs may be required to be shown separately.  Fringe
benefits which are included in the indirect cost rate should not be shown here.
 
(4)           Accountable Personal Property.  Include nonexpendable personal
property with an acquisition cost of $1,000 or more and with an expected useful
life of two or more years, and sensitive items regardless of cost.  Form HHS
565, “Report of Accountable Property,” must accompany the contractor’s public
voucher (SF 1034/SF 1035) or this report if not previously submitted.  See
“Contractor’s Guide for Control of Government Property”.
 
(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.
 
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-lncurred 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.
 

 
 

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

 

Attachment 5
 
INCLUSION ENROLLMENT REPORT
 
This report format should NOT be used for data collection from study
participants
Study Title:
Total Enrollment:
Protocol Number:
Contract Number:
 
PART A.  TOTAL ENROLLMENT REPORT: Number of Subjects Enrolled to Date
(Cumulative) by Ethnicity and Race
Ethnic Category
 
Sex/Gender
Females
Males
Unknown or Not Reported
Total
Hispanic or Latino
       
Not Hispanic or Latino
       
Unknown (Individuals not reporting ethnicity)
       
Ethnic Category: Total of All Subjects*
       
Racial Categories
       
American Indian/Alaska Native
       
Asian
       
Native Hawaiian or Other Pacific Islander
       
Black or African American
       
White
       
More than one race
       
Unknown or not reported
       
Racial Categories: Total of All Subjects*
       
PART B.  HISPANIC ENROLLMENT REPORT:
Number of Hispanics or Latinos Enrolled to Date (Cumulative)
Racial Categories
Females
Males
Unknown or Not Reported
Total
American Indian or Alaska Native
       
Asian
       
Native Hawaiian or Other Pacific Islander
       
Black or African American
       
White
       
More Than One Race
       
Unknown or not reported
       
Racial Categories: Total of Hispanics or Latinos**
       
*These totals must agree
**These totals must agree
       

US1DOCS 7749231v1
 
 

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

 

ATTACHMENT 6
 
Research Patient Care Costs
 
(1)           Research patient care costs are the costs of routine and ancillary
services provided to patients participating in research programs described in
this contract.
 
(2)           Research patient care costs shall be computed in a manner
consistent with the principles and procedures used by the Medicare Program for
determining the part of Medicare reimbursement based on reasonable costs.  The
Diagnostic Related Group (DRG) prospective reimbursement method used to
determine the remaining portion of Medicare reimbursement shall not be used to
determine research patient care costs.  Research patient care rates or amounts
shall be established by the Secretary of HHS or his/her duly authorized
representative.
 
(3)           Prior to submitting an invoice for research patient care costs
under this contract, the contractor must make every reasonable effort to obtain
third party payment, where third party payors (including Government agencies)
are authorized or are under a legal obligation to pay all or a portion of the
charges incurred under this contract for research patient care.
 
(4)           The contractor must maintain adequate procedures to identify those
research patients participating in this contract who are eligible for third
party reimbursement.
 
(5)           Only those charges not recoverable from third party payors or
patients and which are consistent with the terms and conditions of the contract
are chargeable to this contract.
 

 
 

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

 

ATTACHMENT 8 - Small Business Subcontracting Plan, dated 5 May 2010.
 

 

 

 

 

 

 

 

 

 

 

 
1 of 22 Pages.

 
 

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

 

DHHS SUBCONTRACTING PLAN REVIEW FORM
 
SB No: B09-005                                           MULTIPLE
AWARD                                                      Yes           No           (if
yes, identify subcontracting plans)
MOD No. (if applicable)
1. Solicitation/Contract No.
 
BAA-BARDA-09-34
2. Title of Acquisition
 
Development of a Large-Scale Manufacturing Process for Bio-Thrax
3. Contractor’s Name
 
Emergent Biodefense
Operations Lansing, Inc.
4. Period of Performance (base & options)
 
7/19/10 through 6/14/15
5. Total Contract Amount (including opinions)
 
$     106,864,347
Total MOD Amt (if applicable)
$     [**]
Base Year (if there are options)
$     54,586,376
6. Option #1 (if applicable)
 
$[**]
Option #2 (if applicable
 
$[**]
Option #3 (if applicable)
 
$[**]
Option #4 (if applicable)
 
$
7.  Contracting Officer/Specialist Name, Bldg., Room, Phone, Fax, & Email:
 
Ethan J. Mueller, 409 3rd Street, SW, Washington, D.C. 20204,
Phone: 202-205-4657, e-mail:  Ethan.Mueller@HHS.Gov.
8. Date Received by SBS for Review:
1. SUBCONTRACTING PLAN TYPE: (check one)
Individual:                      ü
Master:
Commercial:
 
SUBCONTRACTING PLAN REQUIREMENTS
CO
SBS
SBA/PCR
2. Subcontracting Goal Data
A
U
A
U
A
U
a. Total Subcontracting Dollars [(bi-g), except when subcontracting baseline
equals contract value)
 
[**]
ü
 
ü
     
b. Total Subcontracting Dollars & Percentage with Small Businesses (incl. SDB,
WOSB, HUBZone, SDVOSB) – [Percentage of 2.n.]
 
$[**]           and [**]%
ü
 
ü
     
c. Total Subcontracting Dollars & Percentage with Small Disadvantaged Businesses
–  [Percentage of 2.n.]
 
$[**]                      and [**]%
ü
   
ü
   
d. Total Subcontracting Dollars & Percentage with Women-owned Small Businesses
–  [Percentage of 2.n.]
 
$[**]           and [**]%
ü
 
ü
     
e. Total Subcontracting Dollars & Percentage with HUBZone Small Businesses
–  [Percentage of 2.n.]
 
$[**]                      and [**]%
ü
   
ü
   
f. Total Subcontracting Dollars & Percentage with Service-Disabled Veteran Small
Businesses –  [Percentage of 2.n.]
 
$[**]                      and [**]%
ü
   
ü
   
g. Total Subcontracting Dollars & Percentage with “Other” than Small Businesses
–  [Percentage of 2.n.]
 
$[**]           and [**]%
ü
 
ü
     
h. Subcontracting Opportunities (description of all principal products/services
to be subcontracted to all types of concerns)
ü
 
ü
     
i.j.k. Metholodlogy used to develop goals & identify sources (e.g. historical
trends, information on technical and competitive bidding, formula for
calculating goals, etc.)
ü
 
ü
     

Emergent BioDefense Operations Lansing – CONFIDIENTIAL – COMPETITION SENSITIVE
Use or disclosure of the data contained on this sheet is subject to the
restriction on the cover page of this proposal.

 
 

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

 

OFFICE OF SMALL AND DISADVANTAGED BUSINESS UTILIZATION
 
SMALL BUSINESS SUBCONTRACTING PLAN
 
The following outline meets the minimum requirements of section 8(d) of the
Small Business Act, as amended, and implemented by the Federal Acquisition
Regulations (FAR) Subpart 19.7.  The U.S. Department of Health and Human
Services (HHS), Office of Small and Disadvantaged Business Utilization (OSDBU)
recommend offerors use the following format to submit proposed Individual
Subcontracting Plan, including modifications.  It is not intended to replace any
existing Corporate/Commercial Plan that is more extensive.  A subcontracting
Plan is required.  If the estimated cost of the contract may exceed $550,000
(small businesses are excluded).  Questions should be forwarded to the
Contracting Officer or Teneshia Alston, Senior Small Business Analyst
(Teneshia.Alston@HHS.GOV).
 
HHS Operating Division (OPDIV):
BARDA                                                                                                                                         
 
SOLICITATION OR CONTRACT
NUMBER:  BAA-BARDA-09-34                                                                                                                                         
 
DATE OF PLAN:  May 5,
2010                                                                                                                                         
 
CONTRACTOR:  Emergent Biodefense Operations Lansing
Inc.                                                                                                                                         
 
ADDRESS:  3500 N. Martin Luther King Jr.
Blvd.                                                                                                                                         
 
STATE/ZIP CODE:  Lansing, MI
48906                                                                                                                                         
 
DUNN & BRADSTREET
NUMBER:  [**]                                                                                                                                         
 
ITEM/SERVICE (Description):  Development of a Large-Scale Manufacturing
Process                                                                                                                                          
 
for
Bio.Thrax®                                                                                         
 

 

 

 

 

Emergent BioDefense Operations Lansing – CONFIDIENTIAL – COMPETITION SENSITIVE
Use or disclosure of the data contained on this sheet is subject to the
restriction on the cover page of this proposal.

 
 

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

 

NEW/INITIAL CONTRACT
 
PERIOD OF CONTRACT PERFORMANCE (Month, Day & Year): 7/9/10 –
6/14/15                                                                                                                                         
 
Base
$ 54,586,376
Performance Period/Quantity
2 years
Years 1 & 2
     
Option 1:
$ [**]
Performance Period/Quantity
1 year
Year 3
     
Option 2:
$ [**]
Performance Period/Quantity
1 year
Year 4
     
Option 3:
$ [**]
Performance Period/Quantity
1 year
Year 5
     
CLIN 006:
$ [**]
Performance Period/Quantity
1 year
Year 1
     
CLIN 0007
$ [**]
Performance Period/Quantity
1 year
Year 22
     
CLIN 0008:
$ [**]
Performance Period/Quantity
1 month
Year 3
       
$ 106,864,347
Total Contract Cost
 

 
CONTRACT MODIFICATION (if applicable)
 
NEW PERIOD OF CONTRACT PERFORMANCE (Month, Day &
Year):                                                                                                                                         
 
Original/Base
$
Performance Period/Quantity
 
Modification
$
Performance Period/Quantity
 
Task Order
$
Performance Period/Quantity
   
$
Modified Total Contract Cost
 

 
Failure to include the essential information of FAR Subpart 19.7 may cause for
either a delay in acceptance or the rejection of a bid or offer when a
subcontracting plan is required.  “SUBCONTRACT,” as used in this clause, means
any agreement (other than one involving an employer-employee relationship(
entered into by a Federal Government prime contractor or subcontractor
requesting supplies or services required for performance of the contract or
subcontract.
 
If assistance is needed to locate small business sources, contact the Small
Business Specialist (SBS) supporting the OPDIV.  SBS contact information is
located on the OSDBU website (http://www.hhs.gov/osdbu/staff.html) or you may
contact the OSDBU headquarters at (202) 690-7300.
 
HHS current subcontracting goal is 39.9% for small business, including 8(a)
Program Participants (hereafter referred to as SB), 5.00% for Small
Disadvantaged Business, including Alaska Native Corporations (ANC) and Indian
Tribes (hereafter referred to as SDB), 5.00% for women-owned business and
economically disadvantges women-owned business (hereafter referred to as WOSB),
3.00% HubZone business (HUBZone) and 3.00% service disabled veteran-owned small
business (SDVOSB) concerns for Fiscal Year (FY) 2008.  For this procurement, HHS
expects all proposed subcontracting plans to contain at a minimum the
aforementioned percentages.  These percentages shall be expressed as percentages
of the total estimated subcontracting dollars.  Zero goal statement removed.
 
1.               Type of Plan (check one)
 
    X                   Individual plan (all elements developed specifically for
this contract and applicable for the full term of this contract).
 
    X                   Master  plan (goals developed for this contract) all
other elements standardized and approved by a lead agency Federal Official; must
be renewed every three years end contractor must provide copy of lead agency
approval.
 
    X                   Commercial products/service plan (goals are negotiated
with the initial agency on a company-wide basis rather than for individual
contracts) this plan applies to the entire production of commercial service or
items or a portion thereof.  The contractor sells commercial products and
services customarily used for non-government purposes.  The plan is effective
during the offeror’s fiscal year (attach a copy).  The Summary Subcontracting
Report (SSR) must include a breakout of subcontracting prorated for HHS and
other Federal agencies).
 
2.           Goals
 
Below indicate the dollar and percentage goals for Small Business, Small
Disadvantaged (SDB) including Alaska Native Corporations and Indian Tribes,
Woman-owned and Economically Disadvantaged Women-Owned (WOSB), Historically
Underutilized Business Zone (HUBZone), Service Disabled Veteran-owned (SDVOSB)
small businesses and “Other than small business” (Other) as
subcontractors.  Indicate the base year and each option year, as specified in
FAR 19.704 or project annual subcontracting base and goals under commercial
plans.  If any contract has more four options, please attach additional sheets
which illustrate dollar amounts and percentages.
 
 
a.
Total estimated dollar value of ALL planned subcontracting, i.e., with ALL types
of concerns under this contract is $[**] (Base Year 1).

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

FY   11                    Year 2
(Base)
FY   12                    Year 3
(Option 1)
FY   13                    Year 4
(Option 2)
FY   15                    Year 5
(Option 3)
[**]
[**]
 
[**]
 
[**]
 

 
 
b.
Total estimated dollar value and percent of planned subcontracting with SMALL
BUSINESSES (including SDB, WOSB, HUBz and SDVOSB):  (% of “a”)

 
 
$   [**]    and    [**]%    (Base Year 1)

 
FY   11                    Year 2
(Base)
FY   12                    Year 3
(Option 1)
FY   13                    Year 4
(Option 2)
FY   15                    Year 5
(Option 3)
[**]
 
[**]
 
[**]
 
[**]
 

 
 
c.
Total estimated dollar value and percent of planned subcontracting with SMALL
DISADVANTAGED BUSINESSES:  (% of “a”) $[**] and    [**]%    (Base Year 1)

 
FY   11                    Year 2
(Base)
FY   12                    Year 3
(Option 1)
FY   13                    Year 4
(Option 2)
FY   15                    Year 5
(Option 3)
[**]
 
[**]
 
[**]
 
[**]
 

 
 
d.
Total estimated dollar value and percent of planned subcontracting with
WOMAN-OWNED SMALL BUSINESSES:  (% of “a”) $[**] and    [**]%    (Base Year 1)

 
FY   11                    Year 2
(Base)
FY   12                    Year 3
(Option 1)
FY   13                    Year 4
(Option 2)
FY   15                    Year 5
(Option 3)
[**]
 
[**]
 
[**]
 
[**]
 

 
 
e.
Total estimated dollar value and percent of planned subcontracting with HUBZone
SMALL BUSINESSES:  (% of “a”) $[**] and    [**]%    (Base Year 1)

 
FY   11                    Year 2
(Base)
FY   12                    Year 3
(Option 1)
FY   13                    Year 4
(Option 2)
FY   15                    Year 5
(Option 3)
[**]
 
[**]
 
[**]
 
[**]
 

 
 
f.
Total estimated dollar value and percent of planned subcontracting with
SERVICE-DISABLED VETERAN-OWNED SMALL BUSINESSES:  (% of “a”) $[**] and
   [**]%    (Base Year 1)

 
FY   11                    Year 2
(Base)
FY   12                    Year 3
(Option 1)
FY   13                    Year 4
(Option 2)
FY   15                    Year 5
(Option 3)
[**]
 
[**]
 
[**]
 
[**]
 

 
 
g.
Total estimated dollar value and percent of planned subcontracting with “OTHER
THAN SMALL BUSINESSES”.  (As defined by the Small Business Administration as
“any entity t that is not classified as a small business.  This includes large
businesses, state and local governments, non-profit organizations, public
utilities, educational institutions and foreign-owned firms.)  (% of “a”) $[**]
and    [**]%    (Base Year 1)

 
FY   11                    Year 2
(Base)
FY   12                    Year 3
(Option 1)
FY   13                    Year 4
(Option 2)
FY   15                    Year 5
(Option 3)
[**]
 
[**]
 
[**]
 
[**]
 

 
 
Note:
Federal prime contract percentage goals may serve as objectives for
subcontracting goal development:

 
·  
Total Small Business (SB) 19.00%

·  
8(a) Program Participants 5.00%

·  
Small Disadvantaged Business (SDB) 5.00%

·  
Woman Owned Small Business (WOSB) 5.00%

·  
Historically Underutilized Business Zone (HUBZone) 3.00%

·  
Service Disabled Veteran Owned Small Business (SDVOSB) 3.00%

 
h.
Provide a description of ALL the products and/or services to be subcontracted
under this contract, and indicate the size and type of business supplying them
(check all that apply):

 
Products and/or Services
Other
Small Business
SDB
WOSB
Hubz
SDVOSB
1.
[**]
X
X
 
X
   
2.
[**]
X
         
3.
[**]
X
         
4.
[**]
X
         
5.
[**]
 
X
       
6.
[**]
X
         
7.
[**]
 
X
       
8.
[**]
 
X
       
9.
[**]
X
         
10.
[**]
X
         
11.
[**]
X
         
12.
[**]
X
         
13.
[**]
X
         
14.
[**]
X
         
15.
[**]
 
X
       
16.
[**]
 
X
       

 
 
i.
Provide a description of the method used to develop the subcontracting goals for
SB, SDB, WOSB, HUBZone and SDVOSB concerns.  Address efforts made to ensure that
maximum practicable subcontracting opportunities have been made available for
those concerns and explain the method, used to identify potential sources for
solicitation purposes.  Explain the method and state the quantitative basis (in
dollars) used to establish the percentage goals.  Also, explain how the areas to
be subcontracted to SB, WOSB, HUBZone and SDVOSB concerns were determined, how
the capabilities of these concerns were considered contract opportunities and
how such data comports with the cost proposal.  Identify any source lists or
other resources used for the determination process.  (Attach additional sheets,
if necessary.)

 
Emergent Biodefense Operations Lansing Inc (EBOL) solicited proposals from those
sources with the qualifications required to execute the contract.  Those
contractors that best met the business specifications, capability, performance
expectations, cost competitiveness and other relevant criteria were considered
for this effort.
 
Product/Service
Amount to be Subcontracted
Bus. Class
Consultants [**]
   
[**]
[**]
WOSB
[**]
[**]
WOSB
[**]
[**]
SB
[**]
[**]
WOSB
[**]
[**]
Other
[**]
[**]
Other
[**]
[**]
SB
[**]
[**]
Other
[**]
[**]
SB
[**]
[**]
SB
[**]
[**]
SB
Subcontractors
   
[**]
[**]
SB
[**]
[**]
Other
[**]
[**]
Other
[**]
[**]
SB
[**]
[**]
Other
[**]
[**]
Other
[**]
[**]
SB
[**]
[**]
SB
[**]
[**]
Other
[**]
[**]
Other
Professional Travel
   
[**]
[**]
Other
Other Direct Costs
   
[**]
[**]
Other
Materials and Supplies
   
[**]
[**]
Other
[**]
[**]
Other
[**]
[**]
SB
[**]
[**]
SB

 
The proposed .contract leads to FDA approval of large-scale manufacture of
BioThrax, the only FDA approved anthrax vaccine.  Activities required to fulfill
this contract include:
 
–  
[**]

 
–  
[**]

 
–  
[**]

 
–  
[**]

 
EBOL plans to utilize small business concerns to the maximum extent practical
and regularly surveys the healthcare community to identify small businesses with
the skills and experience to undertake research, trials, and vaccine-related
manufacturing.  However, delivery under this-contract will require a niche
skillset and due to the complexity and very specialized nature of the program
there is a very small pool of qualified small businesses from which to make a
selection.
 
As shown above, [**] subcontractors have been identified to fulfill the scope of
this contract of which, [**] are small businesses.
 
The proposed subcontractors with the largest contributions to contract are
[**].  After careful evaluation, these subcontractors were the only companies
that could be identified to perform the activities required for the success of
the project as outlined below:
 
[**]
 
We conducted an extensive search to identify qualified small businesses for each
product/service to be subcontracted for this contract.  The results of the
search are as described below:
 
As it relates to the anthrax vaccine efficacy testing, [**] is the only company
in the world who routinely performs anthrax vaccine efficacy testing that
conforms to federal regulations and guidelines.
 
For clinical studies, [**] were identified as prospective subcontractors.  After
auditing the companies, it was determined that [**] did not have the capability
to conduct the large clinical studies for this contract.  Emergent is using [**]
for clinical trials for other products at earlier stages of development, where
the trials are not as large.  However, for the proposed contract, [**] were
selected to support the clinical trials.
 
Professional Travel
 
[**] – Emergent BioSolutions Inc. (EBSI) and its subsidiaries including Emergent
Biodefense Operations Lansing Inc. (EBOL) use the same travel agency to ensure
continuity of service and cost effectiveness.  EBSI is a global corporation
withoffices in the United States, Europe and Asia.  The travel agency utilized
must have the breadth to manage travel around the globe and across time zones
while supplying the most economical travel.  We regularly evaluate alternatives
to [**] and consider small businesses as they are identified.
 
Other Direct Costs
 
[**] – Clinical Trial Insurance
 
[**]
 
Materials and Supplies
 
[**]
 
[**] .companies [**] providing materials and supplies are small
businesses.  EBOL will continue it’s efforts to seek small businesses to replace
it’s large, business “suppliers that provide products equivalent to those
currently being purchased to ensure adherence for federal and state quality
assurance requirements for the development and manufacture of vaccines.
 
We-have identified small disadvantaged businesses to supply goods and services
that fall within the category of indirect costs.  We utilize these businesses
whenever possible and therefore plan to include general and administrative costs
from purchase of goods and services from small businesses to help meet our small
business subcontracting goals.  We fully support the government’s interests in
supporting small business concerns and will remain diligent in its efforts to
meet the governments overall subcontracting goals and ensure that the maximum
practical subcontracting opportunities are made available to respective small
business concerns during contract performance.
 
 
j.
Indirect costs [**]          been included in the dollar and percentage
subcontracting goals above (check one).

 
 
k.
If indirect costs have been included, explain the method used to determine the
proportionare share of such costs to be allocated as subcontracts to SB, SDB,
WOSB, HUBZone and SDVOSB concerns:

 
EBOL uses SB, SDB, WOSB, HUBZone and SDVOSB suppliers for office supplies,
facility maintenance and other services that are included in its indirect
costs.  The proportionate share of these costs allocated to this contract will
be determined using the following formula:  [**].
 
3.           Program Administrator:
 
NAME:                           [**]                                                                                                   
 
TITLE:                           Director, US Government
Contracts                                                                                                   
 
ADDRESS:                    300 Professional Drive, Suite
250                                                                                                   
 
Gaithersburg, MD
20879                                                                                                   
 
TELEPHONE:                           [**]                                                                                                   
 
E-MAIL:                           [**]                                                                                                   
 
Duties:  Does the individual named above have general overall responsibility for
the company’s subcontracting program i.e., developing, preparing, and executing
subcontracting plans and monitoring performance relative to the requirements of
those subcontracting plans and perform the following duties?  (If NO is checked,
please who in the company performs those duties, or indicate why the duties are
not performed in your company on a separate sheet of paper and submit with the
proposed subcontracting plan.)
 
a.
Developing and promoting company-wide policy initiatives that demonstrate the
company’s support for awarding contacts and subcontracts to SB, SDB, WOSB,
HUBZone and SDVOSB concerns; and for assuring that these concerns are included
on the source lists for solicitations for products and services they are capable
of providing;
   X   
Yes
____
No
b.
Developing and maintaining bidder source lists of SB, SDB, WOSB, HUBZone and
SDVOSB concerns from all possible sources;
   X   
Yes
____
No
c.
Ensuring periodic rotation of potential subcontractors on bidder’s lists;
   X   
Yes
____
No
d.
Assuring that SB, SDB, WOSB, HUBZone and SDVOSB businesses are included on the
bidders’ list for every subcontract solicitation for products and services that
they are capable of providing;
   X   
Yes
____
No
e.
Ensuring that Requests for Proposes (RFPs) are designed to permit the maximum
practicable participating of SB, SDB, WOSB, HUBZone and SDVOSB concerns;
   X   
Yes
____
No
f.
Reviewing subcontract solicitations to remove statements, clauses, etc., which
might tend to restrict or prohibit small, 8(a), SDB, WOSB, HUBZone and SDVOSB
small business participation;
   X   
Yes
____
No
g.
Accessing various sources for the identification of SB, SDB, WOSB, HUBZone and
SDVOSB concerns to include the Central Contractor Registration
(http://www.ccr.gov/), local small business and minority associations, local
chambers of commerce and Federal agencies’ Small Business Offices;
   X   
Yes
____
No
h.
Establishing and maintaining contract and subcontract award records;
   X   
Yes
____
No
i.
Participating in Business Opportunity Workshops, Minority Business Enterprise
Seminars, Trade Fairs, Procurement Conferences, etc.;
   X   
Yes
____
No
j.
Ensuring the SB, SDB, WOSB, HUBZone and SDVOSB concerns are made aware of
subcontracting opportunities and assisting concerns in preparing responsive bids
to the company;
   X   
Yes
____
No
k.
Conducting or arranging for the conduct or training for purchasing personnel
regarding the intent and impact of Section 8(d) of the Small Business Act, as
amended;
   X   
Yes
____
No
l.
Monitoring the company’s subcontracting program performance and making any
adjustments necessary to achieve the subcontract plan goals;
   X   
Yes
____
No
m.
Preparing and submitting timely, required subcontract reports;
   X   
Yes
____
No
n.
Conducting or arranging training for purchasing personnel regarding the intent
and impact of 8(d) of the Small Business Act on purchasing procedures;
   X   
Yes
____
No
o.
Coordinating the company’s activities during the conduct of compliance reviews
by Federal agencies; and
   X   
Yes
____
No

p.           Other duties:
 

 

 

 
4.           Equitable Opportunity
 
Describe efforts the offeror will undertake to ensure that SB, SDB, WOSB,
HUBZone and SDVOSB concerns will have an equitable opportunity to compete for
subcontracts.  These efforts include, but are not limited to, the following
activities:
 
a.           Outreach efforts to obtain sources:
 
 
1.
Contact minority and small business trade associations; 2) contact business
development organizations and local chambers of commerce; 3) attend SB, SDB,
WOSB, HUBZone and SDVOSB procurement conferences and trade fairs; 4) review
sources from the Central Contractor Registration (http://www.ccr.gov/); 5)
review sources from the Small Business Administration (SBA), Central Contractor
Registration (CCR); 6) Consider using other sources such as the National
Institutes of Health (NIH) e-Portals in Commerce, (e-PIC),
(http://epic.od.nih.gov/).  The NIH e-PIC is not a mandatory source; however, it
may be used at the offeror’s discretion; and 7) utilize newspaper and magazine
ads to encourage new sources.

 
 
b.
Internal efforts to guide and encourage purchasing personnel:

 
 
1.
Conduct workshops, seminars and training programs;

 
 
2.
Establish, maintain, and utilize SB, SDB, WOSB, HUBZone and SDVOSB source lists,
guides, and other data for soliciting subcontractors; and

 
 
3.
Monitor activities to evaluate compliance with the subcontracting plan.

 
 
Additional efforts:

 

 

 
5.           Flow Down Clause
 
The contractor agrees to include the provisions under FAR 52.219-8, “Utilization
of Small Business Concerns,” in all acquisitions exceeding the simplified
acquisition threshold that offers further subcontracting opportunities.  All
subcontractors, except small business concerns, that receive subcontracts in
excess of $550,000 ($1,000,000 by construction), must adopt and comply with a
plan similar to the plan required by FAR 52.219-9, “Small Business
Subcontracting Plan.”  Note:  In accordance with FAR 52.212-5(e) and 52.244-6(c)
the contractor is not required to include flow down clause FAR 52.219-9 if it is
subcontracting commercial items.
 
6.           Reporting and Cooperation
 
The contractor gives assurance of 1) cooperation in any studies or surveys that
may be required; 2) submission of periodic reports which illustrate compliance
with the subcontracting plan; 3) submission of its Individual Subcontracting
Report (ISR) and Summary Subcontract Report (SSR); and 4) subcontractors
submission of ISRs and SSRs.  ISRs and SSRs shall be submitted via the
Electronic Subcontracting Reporting System (eSRS) website
https://esrs.symplicity.com/index?_tab=signin&cck=1
 
Reporting Period
Report Due
Due Date
Oct 1 – Mar 31
ISR
4/30
Apr 1 – Sept 30
ISR
10/30
Oct 1 – Sept 30
SSR
10/30
Contract Completion
Year End SDB Report
30 days after completion

 
Please refer to FAR Part 19.7 for instruction concerning the submission of a
Commercial Plan.  SSR is due on 10/30 each year for the previous fiscal year
ending 9/30.
 
 
a.
Submit ISR (bi-annually) for the awarding Contracting Officer’s review and
acceptance via the eSRS website.

 
 
b.
Currently, SSR (annually) must be submitted for the HHS eSRS Agency Coordinator
review and acceptance via the eSRS website.  (Note:  Log onto the OSDBU website
to view the HHS Agency Coordinator contact information
(http://www.hhs.gov/osdbu/staff.html).

 
 
Note:  The Request for Proposal (RFP) will indicate whether a subcontracting
plan is required.  Due to the nature and complexity of many HHS contracts,
particularly the Centers for Medicare and Medicaid (CMS), the contracot may not
be required to submit its subcontracting reports through the eSRS.  The
Contracting Officer will confirm reporting requirements prior to the issuance of
an award.  For more information, contact Teneshia Alston, Agency Coordinator –
eSRS (Teneshia.Alston@HHS.GOV).

 
7.           Recordkeeping
 
FAR 19.704(a)(11) requires a list of the types of records your company will
maintain to demonstrate the procedures adopted to comply with the requirements
and goals in the subcontracting plan.  The following is a recitation of the
types of records the contractor will maintain to demonstrate the procedures
adopted to comply with the requirements and goals in the subcontracting
plan.  These records will include, but not be limited to, the following:
 
a.
SB, SDB, WOSB, HUBZone and SDVOSB source lists, guides and other data
identifying such vendors;

 
b.
Organizations contacted in an attempt to locate SB, SDB, WOSB, HUBZone and
SDVOSB sources;

 
c.
On a contract-by-contract basis, records on all subcontract solicitations over
$100,000 which indicate for each solicitation (1) whether SB, SDB, WOSB, HUBZone
and/or SDVOSB concerns were solicited, if not, why not and the reasons solicited
concerns did not receive subcontract awards;

 
d.
Records to support other outreach efforts, e.g., contacts with minority and
small business trade associations, attendance at small and minority business
procurement conferences and trade fairs;

 
e.
Records to support internal guidance and encouragement provided to buyers
through (1) workshops, seminars, training programs, incentive awards; and (2)
monitoring performance to evaluate compliance with the program and requirements;
and

 
f.
On a contract-by-contract basis, record to support subcontract award data
including the name, address, and business type and size of each
subcontractor.  (This is not required on a contract-by-contract basis for
commercial plans.)

 
g.
Other records to support your compliance with the subcontracting plan:  (Please
describe):

 

 

 

 

 
8.           Timely Payments to Subcontractors
 
FAR 19.702 requires your company to establish and use procedure to ensure the
timely payment of amounts due pursuant to the terms of your subcontracts with
small business concerns, 8(a), SDB, women-owned small business, HubZone and
service disabled veteran-owned small business concerns.
 
Your company has established and used such
procedures:                                                                                                
__X__ Yes                       No
 
9.           Description of Good Faith Effort
 
Maximum practicable utilization of small, 8(a), small disadvantaged,
women-owned, HubZone small and service disabled veteran owned concerns as
subcontractors in Government contracts is a matter of nation all interest with
both social and economic benefits.  When a contractor fails to make a good faith
effort to comply with a subcontracting plan, these objectives are not achieved,
and 15 U.S.C. 637(d)(4)(F) directs that liquidated damages shall be paid by the
contractor.  In order to demonstrate your compliance with a good faith effort to
achieve the small, SDB WOSB, HubZone and SDVOSB small business subcontracting
goals, outline the steps your company plans to take.  These steps will be
negotiated with the contracting official prior to approval of the plan.
 
[**]
 

Emergent BioDefense Operations Lansing – CONFIDIENTIAL – COMPETITION SENSITIVE
Use or disclosure of the data contained on this sheet is subject to the
restriction on the cover page of this proposal.

 
 

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

 

 SIGNATURE PAGE
 
Signatures Required:
 
This subcontracting plan was submitted by:
 
Signature:                      /s/
[**]                                                                                                                  
 
Typed
Name:                                                                                                                                       [**]               
 
Title:                      Director, US Government
Contracts                                                                                                                  
 
Date:                      May 5,
2010                                                                                                                  
 

 
This plan was reviewed by:
 
Signature:                      /s/ Ethan J.
Mueller                                                                                                                  
 
Typed
Name:                                                                                                                                       Ethan
J. Mueller 
 
Title:                      Contracting
Officer                                                                Date:
6/18/10                                                  
 

 
This plan was reviewed by:
 
Signature:                      /s/ Nydia
Sagna                                                                                                                  
 
Typed
Name:                                                                                                                                       Nydia
Sagna                         
 
Title:                      HHS Small Business Specialist
(SBS)                                                                Date:
6/18/2010                                                  
 

 
This plan was reviewed by:
 
Signature:                      *PCR reserve the right to
review*                                                                                                                  
 
Typed
Name:                                                                                                                                       
 
Title:                      Small Business Administration Procurement Center
Representative
 
Date:                      
 

 

Emergent BioDefense Operations Lansing – CONFIDIENTIAL – COMPETITION SENSITIVE
Use or disclosure of the data contained on this sheet is subject to the
restriction on the cover page of this proposal.

 
 

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

 

 
 
 
Biomedical Advanced
Research and Development
Authority (BARDA)
   
RFP No. BAA-BARDA-09-34
March 1, 2010
           
Cost Proposal
Revision 2
4.0 COST SUMMARY
       
CLIN 0001
       
CLIN 1
             
SUMMARY
                                 
YEAR 1
(BASE YR)
YEAR 2
(OPTION YR)
YEAR 3
(OPTION YEAR)
YEAR 4
(OPTION YEAR)
YEAR 5
(OPTION YEAR)
TOTAL
TOTAL LABOR HOURS
 
[**]
[**]
[**]
[**]
[**]
[**]
DIRECT LABOR COST
 
[**]
[**]
[**]
[**]
[**]
[**]
FRINGE BENEFITS
[**]
[**]
[**]
[**]
[**]
[**]
[**]
TOTAL DIRECT LABOR & FRINGE BENEFITS
 
[**]
[**]
[**]
[**]
[**]
[**]
               
DEVELOPMENT OVERHEAD
[**]
[**]
[**]
[**]
[**]
[**]
[**]
               
MATERIALS AND SUPPLIES
 
[**]
[**]
[**]
[**]
[**]
[**]
PROFESSIONAL TRAVEL
 
[**]
[**]
[**]
[**]
[**]
[**]
EQUIPMENT
 
[**]
[**]
[**]
[**]
[**]
[**]
CONSULTANTS
 
[**]
[**]
[**]
[**]
[**]
[**]
OTHER DIRECT COSTS
 
[**]
[**]
[**]
[**]
[**]
[**]
SUBCONTRACTS
 
[**]
[**]
[**]
[**]
[**]
[**]
TOTAL OTHER DIRECT COSTS
 
[**]
[**]
[**]
[**]
[**]
[**]
               
SUBTOTAL:  OTHER DIRECT AND TOTAL LABOR
 
[**]
[**]
[**]
[**]
[**]
[**]
EXCLUSION FROM BASE FOR G&A
 
[**]
[**]
[**]
[**]
[**]
[**]
ADJUSTED BASE FOR G&A
 
[**]
[**]
[**]
[**]
[**]
[**]
G&A
[**]
[**]
[**]
[**]
[**]
[**]
[**]
TOTAL PROPOSED COST EXCLUDING PROFIT
 
[**]
[**]
[**]
[**]
[**]
[**]
PROPOSED PROFIT
[**]
[**]
[**]
[**]
[**]
[**]
[**]
TOTAL PROPOSED PRICE
 
[**]
[**]
[**]
[**]
[**]
[**]
               

 

Emergent BioDefense Operations Lansing – CONFIDIENTIAL – COMPETITION SENSITIVE
Use or disclosure of the data contained on this sheet is subject to the
restriction on the cover page of this proposal.

 
 

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

 

 
CLIN 0002
       
CLIN 2
             
SUMMARY
                                 
YEAR 1
YEAR 2
YEAR 3
YEAR 4
YEAR 5
TOTAL
TOTAL LABOR HOURS
 
[**]
[**]
[**]
[**]
[**]
[**]
DIRECT LABOR COST
 
[**]
[**]
[**]
[**]
[**]
[**]
FRINGE BENEFITS
[**]
[**]
[**]
[**]
[**]
[**]
[**]
TOTAL DIRECT LABOR & FRINGE BENEFITS
 
[**]
[**]
[**]
[**]
[**]
[**]
               
DEVELOPMENT OVERHEAD
[**]
[**]
[**]
[**]
[**]
[**]
[**]
               
MATERIALS AND SUPPLIES
 
[**]
[**]
[**]
[**]
[**]
[**]
PROFESSIONAL TRAVEL
 
[**]
[**]
[**]
[**]
[**]
[**]
EQUIPMENT
 
[**]
[**]
[**]
[**]
[**]
[**]
CONSULTANTS
 
[**]
[**]
[**]
[**]
[**]
[**]
OTHER DIRECT COSTS
 
[**]
[**]
[**]
[**]
[**]
[**]
SUBCONTRACTS
 
[**]
[**]
[**]
[**]
[**]
[**]
TOTAL OTHER DIRECT COSTS
 
[**]
[**]
[**]
[**]
[**]
[**]
               
SUBTOTAL:  OTHER DIRECT AND TOTAL LABOR
 
[**]
[**]
[**]
[**]
[**]
[**]
EXCLUSION FROM BASE FOR G&A
 
[**]
[**]
[**]
[**]
[**]
[**]
ADJUSTED BASE FOR G&A
 
[**]
[**]
[**]
[**]
[**]
[**]
G&A
[**]
[**]
[**]
[**]
[**]
[**]
[**]
TOTAL PROPOSED COST EXCLUDING PROFIT
 
[**]
[**]
[**]
[**]
[**]
[**]
PROPOSED PROFIT
[**]
[**]
[**]
[**]
[**]
[**]
[**]
TOTAL PROPOSED PRICE
 
[**]
[**]
[**]
[**]
[**]
[**]
               

 

Emergent BioDefense Operations Lansing – CONFIDIENTIAL – COMPETITION SENSITIVE
Use or disclosure of the data contained on this sheet is subject to the
restriction on the cover page of this proposal.

 
 

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