EXHIBIT 10.1

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Portions herein identified by [*****] have been omitted pursuant to a request
for confidential treatment under Rule 24b-2 of the Securities Exchange Act of
1934, as amended. A complete copy of this document has been filed separately
with the Securities and Exchange Commission.
 
 
 

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PART I – THE SCHEDULE
 
SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS
 
ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES
 
The work plan will detail the key studies in the OrbeShieldTM (oral
beclomethasone 17,21- dipropionate or BDP) development program. The focus of the
work plan is the evaluation of OrbeShieldTM in pre-clinical and non-clinical
studies. [*****]
 
ARTICLE B.2. ESTIMATED COST
 

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

 

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

 

 
c.
The fixed fee for the base period of performance (CLIN 0001 in the table below)
and any exercised contract options (CLINs 0002 and 0003) shall be paid at a rate
equal to [** ***] of actual costs incurred per invoicing period, with the
balance of the maximum fee payable upon successful completion of all work under
each non-severable discrete work segment covered under each CLIN. Payment of the
maximum fee is subject to the following limitations:

 

 
·
The government may withhold the payment of fee if necessary to protect the
government’s interest as set forth in Federal Acquisition Regulation (FAR)
52.216-8, Fixed Fee.

 

 
·
Fixed Fee amounts listed under CLIN 0001 for the Base Segment [*****], CLIN 0002
for the Option 1 Segment [*****] and CLIN 0003 for Option 2 Segment [*****]
represent the maximum amount of fee that can be earned for completing all work
required to complete each discreet non-severable work segment.

 

 
d.
The total estimated ceiling cost of the base period of the contract, CLIN 0001
in the table below, represented by the sum of the total estimated cost plus
fixed fee is [*****]. The Government will not be responsible for any Contractor
incurred costs that exceed this amount unless a modification to the contract is
signed by the Contracting Officer which expressly increases the cost ceiling
pursuant to the Limitation of Cost Clause (FAR Clause 52.232-20) incorporated
into this contract.

 

 
e.
It is estimated that the monies currently obligated will cover performance of
the contract through September 17, 2015.

 

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

 

 
g.
 

 
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Portions herein identified by [*****] have been omitted pursuant to a request
for confidential treatment under Rule 24b-2 of the Securities Exchange Act of
1934, as amended. A complete copy of this document has been filed separately
with the Securities and Exchange Commission.
 
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ARTICLE B. 3. OPTION PRICES
 
Unless the government exercises contract options pursuant to Federal Acquisition
Regulation (FAR) 52.217-9, Option to Extend the Term of the Contract, the
contract consists only of the base work specified in the Statement of Work as
defined in SECTIONS C and F, with estimated costs set forth in ARTICLE B.2 of
the contract.
 
Pursuant to FAR 52.217-9, Option to Extend the Term of the Contract, set forth
in full in ARTICLE I.3., the Government may, by unilateral contract
modification, require the Contractor to perform discrete packages of additional
work as specified in the Statement of Work. The Government must give the
Contractor a preliminary written notice of its intent to exercise any contract
option at least 60 days prior to the beginning of the period of performance of
that contract option. The estimated cost of this contract would then be
increased as set forth below:
 
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ARTICLE B.4. LIMITATIONS APPLICABLE TO DIRECT COSTS
 
a.
Items Unallowable Unless Otherwise Provided

 
Notwithstanding the clause FAR 52.216-7, Allowable Cost and Payment,
incorporated in this contract, the costs of the following items or activities
shall be unallowable as direct costs  unless authorized in writing in advance by
the Contracting Officer:
 
Portions herein identified by [*****] have been omitted pursuant to a request
for confidential treatment under Rule 24b-2 of the Securities Exchange Act of
1934, as amended. A complete copy of this document has been filed separately
with the Securities and Exchange Commission.
 
 
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1.
Acquisition, by purchase or lease, of any interest in real property;

Portions herein identified by [*****] have been omitted pursuant to a request
for confidential treatment under Rule 24b-2 of the Securities Exchange Act of
1934, as amended. A complete copy of this document has been filed separately
with the Securities and Exchange Commission.
 

 
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. 
Unapproved foreign travel;

 

 
6. 
Consultant costs;

 

 
7. 
Subcontracts;

 

 
8. 
Patient care costs;

 

 
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 available
athttp://fast.faa.gov/archive/v0702/docs/html_version/contractor_guide/chapter1.htm,
regardless of acquisition value.)

 

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

 

 
11. 
Light Refreshment and Meal Expenditures - Requests to use contract funds to
provide light refreshments and/or meals to either federal or nonfederal
employees must be submitted to the Contracting Officer’s Representative (COR),
with a copy to the Contracting Officer, at least six (6) weeks in advance of the
event and are subject to “HHS Policy on Promoting Efficient Spending: Use of
Appropriate Funding for Conferences and Meeting, Food and Promotional Items and
Printing and Publications.” The request shall contain the following information:
(a) name, date, and location of the event at which the light refreshments and/or
meals will be provided; (b) a brief description of the purpose of the event; (c)
a cost breakdown of the estimated light refreshments and/or meals costs; (d) the
number of nonfederal and federal attendees receiving light refreshments and/or
meals; and (e) if the event will be held at a government facility.

 

 
12. 
Meeting room or conference space used for face to face meetings with USG staff
in the performance of this contract. Justification for why the meeting cannot be
held at a government facility must be provided. COA requests must be made at
least (2) two weeks prior to meeting date.

 

 
13. 
Purchasing of animals and/or other supplies for non-clinical studies

 
b.
Travel Costs

 
Total expenditures for domestic travel (transportation, lodging, subsistence,
and incidental expenses such as taxis or airport parking) incurred by the Prime
Contractor in direct performance of this contract during the base period shall
not exceed [****] without the prior written approval of the Contracting Officer.
Total expenditures for foreign travel (transportation, lodging, subsistence, and
incidental expenses such as taxis or airport parking) incurred by the Prime
Contractor in direct performance of this contract during the base period shall
not exceed [****]without the prior written approval of
 
Portions herein identified by [*****] have been omitted pursuant to a request
for confidential treatment under Rule 24b-2 of the Securities Exchange Act of
1934, as amended. A complete copy of this document has been filed separately
with the Securities and Exchange Commission.
 
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the Contracting Officer. (Please refer to Item 3., below, for guidelines
regarding approval for foreign travel.) The Prime Contractor shall notify the
Contracting Officer in writing when travel has exceeded the amounts allowed for
domestic and/or foreign travel within the base period. Cost must be consistent
with FAR 52.247-63 – Preference for U.S.-Flag Air Carriers
 

 
1.
If, pursuant to FAR Clause 52.217-9 (Option to Extend the Term of the Contract),
the Government exercises an option, domestic and foreign travel costs for each
CLIN shall not exceed the following schedule:

 
Option 1 (CLIN 0002) - [****]
Option 2 (CLIN 0003) - [****]
 

 
2.
Subject to the dollar limitation of[****]                                , the
Contactor shall invoice and be reimbursed for all travel costs in accordance
with FAR 31.703.

 

 
3.
Requests for foreign travel and attendance at any general scientific meetings
must be submitted at least six weeks in advance and shall contain the following:

 
(i) meeting(s) and place(s) to be visited, with costs and dates;
(ii) names(s) and title(s) of Contractor personnel to travel and their functions
in the contract project;
(iii) contract purpose to be served by the travel;
(iv) how travel of Contractor personnel will benefit and contribute to
accomplishing the contract project, or will otherwise justify the expenditure of
AMCG contract funds;
(v) how such advantages justify the costs for travel and absence from the
project of more than one person if such are suggested; and
(vi) what additional functions may be performed by the travelers to accomplish
other purpose of the contact and thus further benefit the project.
 
ARTICLE B.4. ADVANCE UNDERSTANDINGS
 

 
a. 
A Security Plan is currently not required at the initial point for this effort.
However, a security waiver for the security plan will be requested. In the event
a security waiver cannot successfully be obtained and approved, a security plan
must subsequently be delivered to the Government.

 
Security Reporting Requirement –Violations of established security protocols
shall be reported to the Contracting Officer (CO) and Contracting Officer’s
Representative (COR) upon discovery within 24 hours of its receipt of any
compromise, intrusion, loss or interference of its security processes and
procedures. The Contractor shall ensure that all software components that are
not required for the operation and maintenance of the database/control system
has been removed and/or disabled. The Contractor shall provide to the CO and the
COR information appropriate to Information and Information Technology software
and service updates and/or workarounds to mitigate all vulnerabilities
associated with the data and shall maintain the required level of system
security.
 
The Contractor will investigate violations to determine the cause, extent, loss
or compromise of sensitive program information, and corrective actions taken to
prevent future violations. The Contracting Officer in coordination with BARDA
will determine the severity of the violation. Any contractual actions resulting
from the violation will be determined by the Contracting Officer.
 
Portions herein identified by [*****] have been omitted pursuant to a request
for confidential treatment under Rule 24b-2 of the Securities Exchange Act of
1934, as amended. A complete copy of this document has been filed separately
with the Securities and Exchange Commission.
 
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b.
Subcontracts and Consultants

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

 
·
Is of the cost-reimbursement type;

 

 
·
Is Fixed-Price and exceeds $150,000 or 5% of the total estimated cost of the
Contract, whichever value is greater.

 
The Contracting Officer shall request appropriate supporting documentation in
order to review and determine authorization, pursuant with FAR Clause 52.244-2,
Subcontracts. After receiving written consent of the subcontract or consulting
agreement/subcontract by the Contracting Officer, a copy of the signed, executed
subcontract or consulting agreement/subcontract shall be provided to the
Contracting Officer.
 
Note: Consulting services are treated as subcontracts and subject to the
‘consent to subcontract’ provisions set forth in this Article.
 
The Contractor will negotiate [****]                            type
subcontracts with the following subcontractors in the base period of the
contract with total costs not to exceed the amounts listed in the chart below.
Award of the following subcontract shall not proceed without the prior written
approval of the Contracting Officer upon review of the draft subcontract as
required by the FAR Clause 52.244-2, Subcontracts. After written approval of the
subcontract by the Contracting Officer, a copy of the signed, approved
subcontract shall be provided to the Contracting Officer.
 
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c. 
Reference FAR 52.244-2(e) Subcontracts

 
FAR 52.244-2, Subcontracts (Oct 2010)
 
(e)(1) The Contractor shall notify the Contracting Officer reasonably in advance
of placing any subcontract or modification thereof for which consent is required
under paragraph (d) of this clause, including the following information:
 
(i).
A description of the supplies or services to be subcontracted.

(ii).
Identification of the type of subcontract to be used.

(iii).
Identification of the proposed subcontractor.

(iv).
The proposed subcontract price.

(v).
The subcontractor’s current, complete, and accurate cost or pricing data and
Certificate of Current Cost or Pricing Data, if required by other contract
provisions.

(vi).
The subcontractor’s Disclosure Statement or Certificate relating to Cost
Accounting standards when such data are required by other provisions of this
contract.

(vii).
A negotiation memorandum reflecting-

 
    (A).
The principal elements of the subcontract price negotiations;

    (B).
The most significant considerations controlling establishment of initial or
revised prices;

    (C).
The reason cost or pricing data were or were not required;

    (D).
The extent, if any, to which the Contractor did not rely on the subcontractor’s
cost or pricing data in determining the price objective and in negotiating the
final price;

    (E).
The extent to which it was recognized in the negotiation that the
subcontractor’s cost or pricing data were not accurate, complete, or current;
the action taken by the Contractor and the subcontractor; and the effect of any
such defective data on the total price negotiated;

 
Portions herein identified by [*****] have been omitted pursuant to a request
for confidential treatment under Rule 24b-2 of the Securities Exchange Act of
1934, as amended. A complete copy of this document has been filed separately
with the Securities and Exchange Commission.
 
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    (F).
The reasons for any significant difference between the Contractor’s price
objective and the price negotiated; and 

    (G).
A complete explanation of the incentive fee or profit plan when incentives are
used. The explanation shall identify each critical performance element,
management decisions used to quantify each incentive element, reasons for the
incentives, and a summary of all trade-off possibilities considered.

 

 
d.
Site Visits, Inspections and Audits

 
At the discretion of the USG and independent of activities conducted by the
Contractor, with 48 hours notice to the contractor, the USG reserves the right
to conduct site visits and inspections on an as needed basis, including
collection of product samples and intermediates held by the contractor, or
subcontractor. All costs reasonably incurred by the Contractor and subcontractor
for such visit and/or inspection shall be allowed costs. The Contractor shall
coordinate these visits and shall have the opportunity to accompany the USG on
any such visits. Under time-sensitive or critical situations, the USG reserves
the right to suspend the 48 hour notice to the Contractor. The areas included
under the site visit could include, but are not limited to: security, regulatory
and quality systems, and cGMP/GLP/GCP compliance.
 
If the Government, Contractor, or other party identifies any issues during an
audit, the Contractor shall capture the issues, identify potential solutions,
and provide a report to the Government for review and acceptance.
 
 
·
If issues are identified during the audit, Contractor shall submit a report to
the CO and COR within 10 business days detailing the finding and corrective
action(s) of the audit.

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

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

 

 
e.
Quality Assurance Audit:

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

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

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

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

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

 
b.
Fringe Benefits - Cite rate and amount

 
c.
Overhead - Cite rate and amount

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

 
e.
Travel - Identify travelers, dates, destination, purpose of trip, and amount.
Cite COA, if appropriate. List separately, domestic travel, general scientific
meeting travel, and foreign travel.

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

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

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

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

 
j.
G&A - Cite rate and amount.

 
k.
Fee

 
l.
Total Cost Plus Fixed Fee

 
Monthly invoices must include the cumulative total expenses to date, adjusted
(as applicable) to show any amounts suspended by the Government. In order to
verify allowability, further breakdown of costs may be requested at the
Government’s discretion.
 
See Attachment 6, Invoice/Financing Request Instructions and Contract Financial
Reporting Instructions for BARDA Cost-Reimbursement Type Contracts, for
additional instructions.
 

 
g. 
Confidential Treatment of Sensitive Information

 
The Contractor shall, to the extent permitted by law, guarantee strict
confidentiality of the information/data that is provided by the Government
during the performance of the contract. The Government has determined that the
information/data that the Contractor will be provided during the performance of
the contract is of a sensitive nature.
 
Disclosure of the information/data, in whole or in part, by the Contractor can
only be made after the Contractor receives prior written approval from the
Contracting Officer. Whenever the Contractor is uncertain with regard to the
proper handling of information/data under the contract, the Contractor shall
obtain a written determination from the Contracting Officer.
 
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.

 
 
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The 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 (b) otherwise required by law,
(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
 

 
h. 
Sharing of contract deliverables within United States Government (USG)

 
In an effort to build a robust medical countermeasure pipeline through increased
collaboration, BARDA may share technical deliverables with USG entities
responsible for Medical Countermeasure Development. In accordance with
recommendations from the Public Health Emergency Medical Countermeasure
Enterprise Review, agreements established in the Integrated Portfolio’s
Portfolio Advisory Committee (PAC) Charter, and agreements between BARDA and the
Department of Defense and the National Institutes of Health, BARDA may share
technical deliverables and data created in the performance of this contract with
colleagues within the Integrated Portfolio. This advance understanding does not
authorize BARDA to share financial information outside HHS. The Contractor is
advised to review the terms of FAR 52.227-14, Rights in Data – General,
regarding the Government’s rights to deliverables submitted during performance
as well as the Government’s rights to data contained within those deliverables.
 

 
i. 
Overtime Compensation

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

 
j. 
Contract Number Designation

 
On all correspondence submitted under this contract, the Contractor agrees to
clearly identify the contract number that appears on the face page of the
contract as follows:
 
HHSO100201300023C
 
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 August 22, 2013 set forth in SECTION J - List of
Attachments, attached hereto and made a part of the contract.
 
ARTICLE C.2. REPORTING REQUIREMENTS
 
All reports required herein shall be submitted in electronic format. All
paper/hardcopy documents/reports submitted under this contract shall be printed
or copied, double-sided, on at least 30 percent post consumer fiber paper,
whenever practicable, in accordance with FAR 4.302(b).
 
 
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ARTICLE C.3. SUBJECT INVENTION REPORTING REQUIREMENT
 
All reports and documentation required by FAR Clause 52.227-11, Patent
Rights-Ownership by the Contractor, including, but not limited to, the invention
disclosure report, the confirmatory license, and the Government support
certification, one copy of an annual utilization report, and a copy of the final
invention statement, shall be submitted to the Contracting Officer. A final
invention statement (see FAR 27.303 (b)(2)(ii)) shall be submitted to the
Contracting Officer on the expiration date of the contract.
 
Reports and documentation submitted to the Contracting Officer shall be sent to
the Contracting Officer to the address set forth in SECTION G – CONTRACT
ADMINISTRATION DATA.
 
If no invention is disclosed or no activity has occurred on a previously
disclosed invention during the applicable reporting period, a negative report
shall be submitted to the Contracting Officer at the address listed above.
 
ARTICLE C.4. TWICE MONTHLY CONFERENCE CALLS
 
A conference call between the Contracting Officer’s Representative and designees
and the Contractor’s Project Leader/delegate and designees shall occur
twice-monthly or as directed by the Contracting Officer’s Representative. During
this call the Contractor’s Project Leader/delegate and designees will discuss
the activities since the last call, any problems that have arisen and the
activities planned until the next call takes place. The Contractor’s Project
Leader/delegate may choose to include other key personnel on the conference call
to give detailed updates on specific projects or this may be requested by the
Contracting Officer’s Representative.
 
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
Representative. These meetings may include face-to-face meetings with AMCG/BARDA
in Washington, D.C. and at work sites of the Contractor. Such meetings may
include, but are not limited to, meetings of the Contractor to discuss study
designs, site visits to the Contractor’s facilities, and meetings with the
Contractor and HHS officials to discuss the technical, regulatory, and ethical
aspects of the program. Subject to the data rights provisions in this contract,
the Contractor will provide data, reports, and presentations to groups of
outside experts and USG personnel as required by the Contracting Officer’s
Representative in order to facilitate review of contract activities.
 
ARTICLE C.6. FACE-TO-FACE PROJECT REVIEW MEETING
 
The contractor shall, at a time to be determined later but estimated to be the
23rd month of contract performance, present a comprehensive review of contract
progress to date in a face-to-face meeting in Washington, DC. The contractor
will be responsible for updating BARDA leadership on technical progress under
the Statement of Work.
 
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 date, contract number and Contractor name.
The Contractor shall guarantee that all required materials shall be delivered in
immediate usable and acceptable condition.

 
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Report Deliverables
 
Unless otherwise specified by the Contracting Officer, delivery of reports to be
furnished to the Government under this contract (including invoices) shall be
delivered to BARDA electronically along with a concurrent email notification to
the Contracting Officer, Contract Specialist, and COR (as defined in SECTION G,
CONTRACT ADMINISTRATION) summarizing the electronic delivery.
 
SECTION E – INSPECTION AND ACCEPTANCE
 
The Contracting Officer or the duly authorized representative will perform
inspection and acceptance of materials and services to be provided under this
contract.
 
For the purpose of this SECTION E, the designated Contracting Officer’s
Representative (COR) is the authorized representative of the Contracting
Officer. The COR will assist in resolving technical issues that arise during
performance. The COR however is not authorized to change any contract terms or
authorize any changes in the Statement of Work or modify or extend the period of
performance, or authorize reimbursement of any costs incurred during
performance. The contractor is advised to review FAR 52.243-2, Changes-Cost
reimbursement contracts Alternative V, which is incorporated by reference into
this contract in ARTICLE I.1.
 
Inspection and acceptance will be performed at:
 
Office of Acquisition Management, Contracts, and Grants (AMCG)
Office of the Assistant Secretary for Preparedness and Response
U.S. Department of Health and Human Services
330 Independence Avenue, S.W., Room G644
Washington, D.C. 20201
 
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 52.246-9, Inspection of Research and Development – Short Form (Apr 1984)
 
SECTION F – DELIVERIES OR PERFORMANCE
 
ARTICLE F.1. ESTIMATED PERIOD OF PERFORMANCE
 
Under CLIN 0001 the estimated technical period of performance for the base
period of this contract shall be from September 18, 2013 through September 17,
2015. The period of performance encompasses the review of the Draft Final Report
and the submission of the Final Report 30 days after the technical period of
performance to allow for completion of the Final Report(s), as specified in the
REPORTING REQUIREMENTS Article in SECTION C.2 of this contract.
 
 
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ARTICLE F.2. DELIVERABLES
 
Successful performance of the final contract shall be deemed to occur upon
performance of the work set forth in the Statement of Work dated August 22, 2013
set forth in SECTION J - List of Attachments of this contract and upon delivery
and acceptance, as required by the Statement of Work, by the Contracting
Officer, or the duly authorized representative, of each of the deliverables
described in SECTION C, SECTION F and SECTION J, Attachment 2 of this contract.
Each deliverable must be delivered electronically to the Contracting Officer or
Contract Specialist, Contracting Officer’s Representative, and Alternate
Contracting Officer’s Representative in accordance with the Deliverable Schedule
set forth below:
 
Item
 
Description
 
Quantity
 
Addresses
 
Deliverable Schedule
Technical Progress Reports
1)
 
Monthly Progress Report
 
3 electronic
 
CO or CS: (1) electronic copy
 
COR: (1) electronic copy
 
Alternate COR: (1) electronic copy
 
The 15th calendar day of each month following the first full month of the
contract award. The Monthly Progress Report will not be required on months when
an Annual or Final Technical Progress Report is due.
2)
 
Annual Progress Report
 
3 electronic
 
CO or CS: (1) electronic copy
 
COR: (1) electronic copy
 
Alternate COR: (1) electronic copy
 
The 15th calendar day of the month following the end of each 12 month
performance period. The Monthly Progress Report will not be required on months
when an Annual Progress Report is due.
3)
 
Draft Final Technical Progress Report
 
3 electronic
 
CO or CS: (1) electronic copy
 
COR: (1) electronic copy
 
Alternate COR: (1) electronic copy
 
45 Calendar days before the completion date of the contract.
5)
 
Summary of salient Results
 
3 electronic
 
CO: (1) electronic copy
 
COR: (1) electronic copy
 
Alternate COR: (1) electronic copy
 
On or before the expiration date of the contract.
 
Other Technical Reports
 
6)
 
Audit Reports
 
3 electronic
 
CO or CS: (1) electronic copy
 
COR: (1) electronic copy
 
Alternate COR: (1) electronic copy
 
Within 30 Calendar days of the audit.
7)
 
FDA/ Regulatory Agency Correspondence and Meeting Summaries
 
3 electronic
 
CO or CS: (1) electronic copy
 
COR: (1) electronic copy
 
Alternate COR: (1) electronic copy
 
Within 5 business days of each meeting for Contractor’s minutes and upon receipt
of minutes from FDA/ regulatory agency.
8)
 
FDA/ Regulatory Agency Submissions
 
3 electronic
 
CO or CS: (1) electronic copy
 
COR: (1) electronic copy
 
Alternate COR: (1) electronic copy
 
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.

 
 
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Other Reports
 
9)
 
Invention Report Annual Utilization Report
 
3 electronic
 
CO or CS: (1) electronic copy
 
COR or CS: (1) electronic copy
 
Alternate COR: (1) electronic copy
 
Due on or before the 30th of the month following each anniversary date of the
contract.
10)
 
Final Invention Report
 
3 electronic
 
CO or CS: (1) electronic copy
 
COR: (1) electronic copy
 
Alternate COR: (1) electronic copy
 
Due on or before the completion date of the contract.
 
Other Deliverables
 
11)
 
Kickoff Meeting
 
N/A
 
N/A
 
Within a month of contract award.
12)
 
Twice monthly Teleconference and meeting minutes
 
3 electronic
 
CO or CS: (1) electronic copy
 
COR: (1) electronic copy
 
Alternate COR: (1) electronic copy
 
Twice monthly or as otherwise agreed by the parties or determined by the
Contracting Officer. Electronic copy of conference call meeting
minutes/summaries to be provided within seven (7) calendar days after the
conference call is held.
13)
 
Face-to-Face progress review meeting presentation
 
3 electronic
 
CO or CS: (1) electronic copy
 
COR: (1) electronic copy
 
Alternate COR: (1) electronic copy
 
Within the 23nd month of the period of performance of the contract, unless
otherwise agreed by the parties. Presentation must be delivered 30 days prior to
the scheduled meeting.

 
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Unless otherwise specified by the Contracting Officer, the above items #1-13
shall be delivered electronically along with a concurrent email notification
email sent to the Contracting Officer or Contract Specialist, COR, and Alternate
COR stating delivery has been made.
 
Please refer to Attachment 2, Milestone and Deliverables, for a list of
additional deliverables.
 
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:.
 

 
A.
Monthly Progress Report

 
This report shall include a description of the activities during the reporting
period, and the activities planned for the ensuing reporting period. The first
reporting period consists of the first full month of performance plus any
fractional part of the initial month. Thereafter, the reporting period shall
consist of each calendar month.
 
The Contractor shall submit a Monthly Progress Report on or before the 15th
calendar day following the last day of each reporting period and shall include
the following:
 
A cover page that includes the contract number and title; the type of report and
period that it covers; the Contractor's name, address, telephone number, fax
number, and e-mail address; and the date of submission;
 
SECTION I - An introduction covering the purpose and scope of the contract
effort; SECTION II – PROGRESS
 
SECTION II Part A: OVERALL PROGRESS - A description of overall progress;
 
SECTION II Part B: MANAGEMENT AND ADMINISTRATIVE UPDATE - A description of all
significant meetings, conference calls, etc., including those between Contractor
and any federal agency, subcontractor or collaborator that have taken place
during the reporting period and relate to the Contract of the Statement of Work.
Include progress on administration and management issues (e.g. evaluating and
managing subcontractor performance and personnel changes);
 
SECTION II Part C: TECHNICAL PROGRESS - For each activity related to the Gantt
chart, document the results of work completed and costs incurred during the
period covered in relation to proposed progress, effort and budget. The report
shall be in sufficient detail to explain comprehensively the results achieved.
The description shall include pertinent data and/or graphs in sufficient detail
to explain any significant results achieved and preliminary conclusions
resulting from analysis and scientific evaluation of data accumulated to date
under the contract. 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, and a
current/updated Gantt chart.
 
A Monthly Progress Report will not be required in the same month that the Annual
or Final Technical Progress Reports are submitted.

 
 
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B. 
Annual Progress Reporting Requirement

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

 
These reports are to include a summation of the work performed and results
obtained for the entire contract period of performance. This report shall be in
sufficient detail to describe comprehensively the results achieved. The Draft
Final Report and Final Report shall be submitted in accordance with the
DELIVERIES Article in SECTION F of the contract. The Draft Final Technical
Progress Report shall be submitted forty-five (45) calendar days before
completion date of the contract and the Final Technical Progress Report shall be
submitted 30 days post technical period of performance. 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,
e-mail 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
related to the Gantt chart, the results obtained, and the impact of the results
on the scientific and/or public health community, including a listing of all
manuscripts (published and in preparation) and abstracts presented during the
entire period of performance, and a summary of all inventions.
 
Draft Final Technical Progress Report: The Contractor is required to submit the
Draft Final Technical Progress Report to the Contracting Officer's
Representative and Contracting Officer. This report is due 45 calendar days
before the completion date of the contract. The Contracting Officer's
Representative and Contracting Officer will review the Draft Final Technical
Progress Report and provide the Contractor with comments within 15 calendar days
after receipt.
 
Final Technical Progress Report: The contractor shall address all BARDA comments
in the Final Technical Progress Report. The Contractor will deliver the final
version of the Final Technical Progress Report 30 days post technical period of
performance.
 

 
D. 
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.
 

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

 

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

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

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

 
d.
The contractor shall provide BARDA the opportunity to review and comment upon
any documents to be submitted to the FDA or other regulatory agency. The
contractor shall provide BARDA with five (5) business days in which to review
and provide comments back to the contractor prior to the contractor’s submission
to the FDA.

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

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

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

 
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F.
Other Reports/Deliverables

 

 
a. 
Technology Transfer

Technology packages developed under the contract that include complete protocols
and critical reagents developed and/or improved with contract funding must be
submitted at the request of the BARDA Contracting Officer’s Representative. See
FAR clauses 52.227-11, Patent Rights-Ownership by the Contractor, and 52.227-14,
Rights in Data.
 

 
b. 
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 Representative.
 

 
c. 
Experimental Protocols

The Contractor shall submit all study/experiment/test plans, designs, and
protocols upon request by the COR.
 

 
d. 
Data

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

 
e. 
Meeting Minutes

The Contractor shall provide an electronic copy of conference call meeting
minutes/summaries to the BARDA Contracting Officer’s Representative and
Contracting Officer within seven (7) calendar days after the conference call is
held.
 
Additional Addresses Listed for Reference, if needed:
 
AMCG/BARDA Security Specialist
Office of the Assistant Secretary                                         for
Preparedness and Response                                Office of  Public
Health Emergency Medical Countermeasures 409 3rd Street, S.W. Suite 320
Washington, DC 20201 E-mail: [****]

 
SECTION G - CONTRACT ADMINISTRATION DATA
 
ARTICLE G.1. CONTRACTING OFFICER
 
The following Contracting Officer (CO) will represent the Government for the
purpose of this contract:
 
Contracting Officer
DHHS/OS/ASPR/AMCG
330 Independence Avenue, S.W. Room G640
Washington, D.C. 20201
 
a. 
The Contracting Officer (CO) is the only individual who can legally commit the
Government to the expenditure of public funds. No person other than the CO can
make any changes to the terms, conditions, general provisions, specifications or
other requirements of this contract.

 
Portions herein identified by [*****] have been omitted pursuant to a request
for confidential treatment under Rule 24b-2 of the Securities Exchange Act of
1934, as amended. A complete copy of this document has been filed separately
with the Securities and Exchange Commission.
 
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b.
The Contracting Officer (CO) is the only person with authority to act as agent
of the Government under this contract. Only the CO has authority to: (1) direct
or negotiate any changes in the statement of work; (2) modify or extend the
period of performance; (3) change the delivery schedule; (4) authorize
reimbursement to the Contractor for any costs incurred during the performance of
this contract; or (5) otherwise change any terms and conditions of this
contract.

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

 
d.
The Government may unilaterally change its CO designation.

 
ARTICLE G.2. CONTRACTING OFFICER'S REPRESENTATIVE (COR)
 
The following Contracting Officer's Representative (COR) will represent the
Government for the purpose of this contract:
 
[****]
 
Contracting Officer's Representative
Biomedical Advanced Research and Development Authority (BARDA)
Office of the Assistant Secretary for Preparedness and Response
Department of Health and Human Services
[****]
[****]
 
Mailing Address:
330 Independence Avenue, S.W. Room 640G
Washington, D.C. 20201
 
Alternate PO/COR:
[****]
 
Alternate Project Officer (PO), Alternate Contracting Officer’s Representative
(COR)
Biomedical Advanced Research and Development Authority (BARDA)
Office of the Assistant Secretary for Preparedness and Response
Department of Health and Human Services
[****]
[****]
 
Mailing Address:
330 Independence Avenue, SW
Washington, D.C. 20201
 
The COR is responsible for:

 
a.
Monitoring the Contractor's technical progress, including the surveillance and
assessment of performance and recommending to the Contracting Officer changes in
requirements;

 
b.
Assisting the Contracting Officer in interpreting the statement of work and any
other technical performance requirements;

 
c.
Performing technical evaluation as required;

 
d.
Performing technical inspections and assisting the Contracting Officer in
acceptances of deliverables required by this contract; and

 
Portions herein identified by [*****] have been omitted pursuant to a request
for confidential treatment under Rule 24b-2 of the Securities Exchange Act of
1934, as amended. A complete copy of this document has been filed separately
with the Securities and Exchange Commission.
 
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e.
Assisting in the resolution of technical problems encountered during
performance. The Government may unilaterally change its COR designation(s).

 
ARTICLE G.3. KEY PERSONNEL
 
The key personnel specified in this contract are considered to be essential to
work performance. At least 30 days prior to diverting any of the specified
individuals to other programs or contracts (or as soon as possible, if an
individual must be replaced, for example, as a result of leaving the employ of
the Contractor), the Contractor shall notify the Contracting Officer and shall
submit comprehensive justification for the diversion or replacement request
(including proposed substitutions for key personnel) to permit evaluation by the
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.
 
The following individuals are considered to be essential to the work being
performed hereunder:
 
[img006.jpg]
 
ARTICLE G.4. QUARTERLY CONTRACT FINANCIAL REPORT
 

 
a.
Financial reports on the attached Financial Report of Individual
Project/Contract shall be submitted by the Contractor to the CO with a copy to
the COR in accordance with the instructions for completing this form, which
accompany the form, in an original and one electronic copy, not later than the
30th business day after the close of the reporting period. The line entries for
subdivisions of work and elements of cost (expenditure categories), which shall
be reported within the total contract, are discussed in paragraph e., below.
Subsequent changes and/or additions in the line entries shall be made in
writing.

 

 
b.
Unless otherwise stated in the instructions for completing this form, all
columns A through J, shall be completed for each report submitted.

 

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

 

 
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.

 
Portions herein identified by [*****] have been omitted pursuant to a request
for confidential treatment under Rule 24b-2 of the Securities Exchange Act of
1934, as amended. A complete copy of this document has been filed separately
with the Securities and Exchange Commission.
 
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ARTICLE G.5. INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORTING
 

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

 

 
b.
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 at Section J,
Attachment 5.

 

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

 

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

 

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

 

 
f.
All invoice submissions shall be in accordance with FAR Clause 52.232-25, Prompt
Payment.

 
ARTICLE G.6. INDIRECT COST RATES
 
1.
The following interim provisional indirect rates will be utilized for billing
purposes during the period of performance, pending the establishment if final
rates covering each fiscal year of the contractor’s performance.: Fringe
benefits at [****], and Overhead (G&A) at [****] of Total Direct Costs Excluding
Subcontractor Costs. Final rate proposals must be sent to the Contracting
Officer, within 6 months of the fiscal year end. See FAR Clause 52.216-7,
Allowable Cost and Payment.

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

 

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

 

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

 

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

 

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

 
Portions herein identified by [*****] have been omitted pursuant to a request
for confidential treatment under Rule 24b-2 of the Securities Exchange Act of
1934, as amended. A complete copy of this document has been filed separately
with the Securities and Exchange Commission.
 
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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.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 at least once during the
contract period of performance.
 
Interim and final evaluations will be provided to the Contractor as soon as
practicable after completion of the evaluation. The Contractor will be permitted
thirty days to review the document and to submit additional information or a
rebutting statement. If agreement cannot be reached between the parties, the
matter will be referred to an individual one level above the Contracting Officer
whose decision will be final.
 
Copies of the evaluations, Contractor responses, and review comments, if any,
will be retained as part of the contract file, and may be used to support future
award decisions.
 
2      Electronic Access to Contractor Performance Evaluations
 
The Government is undergoing a conversion to a new website for reporting. This
website is http://www.cpars.gov. When the website goes active, Contractors may
access evaluations through a secure website for review and comment by completing
the online registration form.
 
The registration process requires the Contractor to identify an individual that
will serve as a primary contact and who will be authorized access to the
evaluation for review and comment. In addition, the Contractor will be required
to identify an alternate contact that will be responsible for notifying the
cognizant contracting official in the event the primary contact is unavailable
to process the evaluation within the required 30-day time frame.
 
ARTICLE G.9. CONTRACT COMMUNICATIONS/CORRESPONDENCE (JULY 1999)
 
The Contractor shall identify all correspondence, reports, and other data
pertinent to this contract by imprinting the contract number HHSO100201300023C
from Page 1 of the contract.

 
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ARTICLE G.10. GOVERNMENT PROPERTY
 
1. In addition to the requirements of the clause, GOVERNMENT PROPERTY,
incorporated in SECTION I of this contract, the Contractor shall comply with the
provisions of HHS Publication, "Contractor's Guide for Control of Government
Property," which is incorporated into this contract by reference. This document
can be accessed at:
 
http://www.hhs.gov/hhsmanuals/ (HHS Logistics Management Manual)
 
Among other issues, this publication provides a summary of the Contractor's
responsibilities regarding purchasing authorizations and inventory and reporting
requirements under the contract.
 
2. Notwithstanding the provisions outlined in the HHS Publication, "Contractor's
Guide for Control of Government Property," which is incorporated in this
contract in paragraph 1. above, the Contractor shall use the form entitled,
"Report of Government Owned, Contractor Held Property" for submitting summary
reports required under this contract, as directed by the Contracting Officer or
his/her designee. This form is included as an attachment in SECTION J of this
contract.
 
3. Title will vest in the Government for equipment purchased as a direct cost.
 
ARTICLE G.11. EXERCISE OF OPTIONS
 
Unless the Government exercises its option pursuant to the Option Clause set
forth in Section I, Article I.2, the contract will consist only of CLIN 0001 of
the Statement of Work, Deliverables and Requirements as defined in Sections C, F
and J of the contract. Pursuant to FAR Clause 52.217­9 (Option to Extend the
Term of the Contract) set forth in Section I of this contract, under Article
I.2, the Government may, by unilateral contract modification, require the
Contractor to perform the additional CLINs listed in Section B, Article B.3.,
and as also defined in Sections C, F and J of this contract. If the Government
exercises an option, written notice must be given to the Contractor within 30
days after the Government has completed its analysis of the deliverables; and
the Government must give the Contractor a preliminary written notice of its
intent to exercise the option at least 30 days before the contract expires. The
amount of the contract may then be increased as set forth in Section B, Article
B.3 provided that funds are available.
 
SECTION H - SPECIAL CONTRACT REQUIREMENTS
 
ARTICLE H.1. CLINICAL AND NON-CLINICAL RESEARCH
 
H.1.1.    Non-Clinical Research
 
These Non-Clinical Terms apply to all grants and contracts that involve
non-clinical research. Draft protocols for each nonclinical study will be
submitted to the Government for evaluation and comment. The Government shall
have rights to all protocols, data resulting from execution of these protocols,
and final reports, funded by the Government under this contract, as defined in
FAR Clause 52.227-14, Rights in Data – General. The Government reserves the
right to request that the Contractor provide any contract deliverable in a
non-proprietary form, to ensure the Government has the ability to review and
distribute the deliverables, as the Government deems necessary.
 
 
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H.1.1.1.    Safety and Monitoring Issues
 
PHS Policy on Humane Care and Use of Laboratory Animals
 
Before award and then with the annual progress report, the Contractor must
submit to the Government a copy of the current Institutional Animal Care and Use
Committees (IACUC) documentation of continuing review and approval and the
Office of Laboratory Animal Welfare (OLAW- National Institutes of Health)
Federal Wide Assurance (FWA) number for the institution or site.
 
If other institutions are involved in the research (e.g., a multicenter trial or
study), each institution's IACUC must review and approve the protocol. They must
also provide the Government initial documentation and documentation of
continuing review and approval and FWA number.
 
The Contractor must ensure that the applications as well as all protocols are
reviewed by the performing institution’s IACUC.
 
To help ensure the safety of animals used in BARDA funded studies, the
Contractor must provide the Government copies of documents related to all major
changes in the status of ongoing protocols, including the following:
 
 
a)
All amendments or changes to the protocol, identified by protocol version
number, date, or both and date it is valid.

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

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

 
 
d)
Termination or temporary suspension of the protocol.

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

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

 
Contractors must notify the Government by email of any of the above changes
within three business days from the time Contractor becomes aware of such
changes, followed by a letter signed by the institutional business official,
detailing notification of the change of status to the local IACUC and a copy of
any responses from the IACUC.
 
If a non-clinical protocol has been reviewed by an institutional biosafety
committee (IBC) or the NIH Recombinant DNA Advisory Committee (RAC), the
Contractor must provide information about the initial and ongoing review and
approval, if any. See the NIH Guidelines for Research Involving Recombinant DNA
Molecules.
 
H.1.1.2.    Non-Clinical Data and Safety Monitoring Requirements
 
The Contractor shall continue safety monitoring for all non-clinical studies of
investigational drugs, devices, or biologics. FDA expects non-clinical studies
to include safety in addition to efficacy. The Contractor should consider
evaluation of clinical relevant safety markers in the pivotal and non-pivotal,
non-clinical studies.
 
BARDA will work with the Contractors on decisions regarding the type and extent
of safety data accrual to be employed before the start of efficacy or safety
studies.
 
The Contractor shall inform the Government of any upcoming site visits and/or
audits of CRO facilities funded under this effort. The Government reserves the
right to accompany the Contractor on site visits and/or audits of CROs as the
Government deems necessary.

 
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H.1.1.3.    BARDA Review Process of Non-Clinical Trials
 
The Government is under the same policy-driven assurances as NIH in that it has
a responsibility to ensure that mechanisms and procedures are in place to
protect the safety and welfare of animals used in BARDA funded non-clinical
trials. Therefore, before study execution, the Contractor must provide the
following (as applicable) for review and approval by the Government:
 
 
1.
IACUC approved (signed) non-clinical research protocol identified by version
number, date, or both, including details of study design, euthanasia criteria,
proposed interventions, and exclusion criteria.

 
 
2.
Documentation of IACUC approval, including OLAW FWA number, IACUC registration
number, and IACUC name.

 
 
3.
Contractor should reduce the number of animals required for a study using power
of statistics.

 
 
4.
Plans for the management of side effects, rules for interventions and euthanasia
criteria.

 
 
5.
Procedures for assessing and collecting safety data.

 
 
6.
If a study is contracted through CRO(s), work orders and service agreements the
Contractor shall assure that an integrated safety documentation plan is in place
for the study site, pharmacy service records on the dosing material to be used
and excipients, and laboratory services (including histopathology).

 
 
7.
Documentation that the Contractor or CRO and all staff responsible for the
conduct of the research have received required training in the protection and
handling of animals.

 
 
8.
Purchasing of animals and/or other supplies for non-clinical studies funded in
part or in whole by BARDA requires written approval by the Contracting Officer.
The Contractor must have the ability to return/re-sell animals, at purchase
price, to distributor or a third party, in the event that the protocols do not
obtain approval.

 
 
9.
Provide justification for whether studies require good laboratory practice (GLP)
conditions.

 

 
10.
Provide justification for whether studies will be classified as non-pivotal or
pivotal studies.

 
BARDA comments will be forwarded to the Contractor within one week (5 business
days) of receipt of the above information. The Contractor must address in
writing all study design, safety, regulatory, ethical, and conflict of interest
concerns raised by the Government staff to the satisfaction of the Government
before study execution. After receiving the updated documentation that satisfies
the Government, a written Contract Officer Authorization (COA) Letter will be
provided to the Contractor. This COA will provide authorization to the
Contractor to execute the specific nonclinical study funded in part or in whole
by BARDA.
 
In case of problems or issues, the BARDA COR will contact the Contractor within
two weeks (10 business days), with copy to the principal investigator and the
institution’s office of sponsored programs, listing issues and appropriate
actions to be discussed.
 
Final decisions regarding ongoing safety reporting requirements for research not
performed under an Investigational New Drug Application (IND) or investigational
device exemption (IDE) must be made jointly by the Government and the
Contractor.
 
 
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ARTICLE H.2. CARE OF LIVE VERTEBRATE ANIMALS, HHSAR 352.270-5 (October 2009)
 

 
a.
Before undertaking performance of any contract involving animal-related
activities where the species is regulated by USDA, the Contractor shall register
with the Secretary of Agriculture of the United States in accordance with 7
U.S.C. 2136 and 9 CFR sections 2.25 through 2.28. The Contractor shall furnish
evidence of the registration to the Contracting Officer.

 
 
b.
The Contractor shall acquire vertebrate animals used in research from a dealer
licensed by the Secretary of Agriculture under 7 U.S.C. 2133 and 9 CFR Sections
2.1­2.11, or from a source that is exempt from licensing under those sections.

 
 
c.
The Contractor agrees that the care, use and intended use of any live vertebrate
animals in the performance of this contract shall conform with the Public Health
Service (PHS) Policy on Humane Care of Use of Laboratory Animals (PHS Policy),
the current Animal Welfare Assurance (Assurance), the Guide for the Care and Use
of Laboratory Animals (National Academy Press, Washington, DC) and the pertinent
laws and regulations of the United States Department of Agriculture (see 7
U.S.C. 2131 et seq. and 9 CFR Subchapter A, Parts 1-4). In case of conflict
between standards, the more stringent standard shall govern.

 
 
d.
If at any time during performance of this contract, the Contracting Officer
determines, in consultation with the Office of Laboratory Animal Welfare (OLAW),
National Institutes of Health (NIH), that the Contractor is not in compliance
with any of the requirements and standards stated in paragraphs (a) through (c)
above, the Contracting Officer may immediately suspend, in whole or in part,
work and further payments under this contract until the Contractor corrects the
noncompliance. Notice of the suspension may be communicated by telephone and
confirmed in writing. If the Contractor fails to complete corrective action
within the period of time designated in the Contracting Officer's written notice
of suspension, the Contracting Officer may, in consultation with OLAW, NIH,
terminate this contract in whole or in part, and the Contractor's name may be
removed from the list of those contractors with approved Assurances.

 
Note: The Contractor may request registration of its facility and a current
listing of licensed dealers from the Regional Office of the Animal and Plant
Health Inspection Service (APHIS), USDA, for the region in which its research
facility is located. The location of the appropriate APHIS Regional Office, as
well as information concerning this program may be obtained by contacting the
Animal Care Staff, USDA/APHIS, 4700 River Road, Riverdale, Maryland 20737
(E-mail: ace@aphis.usda.gov; Web site: (http://www.aphis.usda.gov/animal
welfare).
 
ARTICLE H.3. ANIMAL WELFARE
 
All research involving live, vertebrate animals shall be conducted in accordance
with the Public Health Service Policy on Humane Care and Use of Laboratory
Animals. This policy may be accessed at:
 
http://grants1.nih.gov/grants/olaw/references/phspol.htm
.
ARTICLE H.4. INFORMATION ON COMPLIANCE WITH ANIMAL CARE REQUIREMENTS
 
Registration with the U. S. Dept. of Agriculture (USDA) is required to use
regulated species of animals for biomedical purposes. USDA is responsible for
the enforcement of the Animal Welfare Act (7 U.S.C. 2131 et.
seq.), http://www.nal.usda.gov/awic/legislat/awa.htm.
 
The Public Health Service (PHS) Policy is administered by the Office of
Laboratory Animal Welfare (OLAW) http://grants2.nih.gov/grants/olaw/olaw.htm. An
essential requirement of the PHS
Policy http://grants2.nih.gov/grants/olaw/references/phspol.htm is that every
institution using live vertebrate animals must obtain an approved assurance from
OLAW before they can receive funding from any component of the U. S. Public
Health Service.
 
 
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The PHS Policy requires that Assured institutions base their programs of animal
care and use on the Guide for the Care and Use of Laboratory Animals
http://www.nap.edu/readingroom/books/labrats/ and that they comply with the
regulations (9 CFR, Subchapter
A) http://www.nal.usda.gov/awic/legislat/usdaleg1.htm issued by the U.S.
Department of Agriculture (USDA) under the Animal Welfare Act. The Guide may
differ from USDA regulations in some respects. Compliance with the USDA
regulations is an absolute requirement of this Policy.
 
The Association for Assessment and Accreditation of Laboratory Animal Care
International (AAALAC) http://www.aaalac.org is a professional organization that
inspects and evaluates programs of animal care for institutions at their
request. Those that meet the high standards are given the accredited status. As
of the 2002 revision of the PHS Policy, the only accrediting body recognized by
PHS is the AAALAC. While AAALAC Accreditation is not required to conduct
biomedical research, it is highly desirable. AAALAC uses the Guide as their
primary evaluation tool. They also use the Guide for the Care and Use of
Agricultural Animals in Agricultural Research and Teaching. It is published by
the Federated of Animal Science Societies http://www.fass.org.
 
ARTICLE H.5. REQUIREMENTS FOR ADEQUATE ASSURANCE OF PROTECTION OF VERTEBRATE
ANIMAL SUBJECTS
 
The PHS Policy on Humane Care and Use of Laboratory Animals requires that
applicant organizations proposing to use vertebrate animals file a written
Animal Welfare Assurance with the Office for Laboratory Animal Welfare (OLAW),
establishing appropriate policies and procedures to ensure the humane care and
use of live vertebrate animals involved in research activities supported by the
PHS. The PHS Policy stipulates that an applicant organization, whether domestic
or foreign, bears responsibility for the humane care and use of animals 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.

 
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ARTICLE H.6. APPROVAL OF REQUIRED ASSURANCE BY OLAW
 
Under governing regulations, federal funds which are administered by the
Department of Health and Human Services, Office of Biomedical Advanced Research
and Development Authority (BARDA) shall not be expended by the Contractor for
research involving live vertebrate animals, nor shall live vertebrate animals be
involved in research activities by the Contractor under this award unless a
satisfactory assurance of compliance with 7 U.S.C. 2316 and 9 CFR Sections
2.25-2.28 is submitted within 30 days of the date of this award and approved by
the Office of Laboratory Animal Welfare (OLAW). Each performance site (if any)
must also assure compliance with 7 U.S.C. 2316 and 9 CFR Sections 2.25-2.28 with
the following restriction: Only activities which do not directly involve live
vertebrate animals (i.e. are clearly severable and independent from those
activities that do involve live vertebrate animals) may be conducted by the
Contractor or individual performance sites pending OLAW approval of their
respective assurance of compliance with 7 U.S.C. 2316 and 9 CFR Sections
2.25-2.28. Additional information regarding OLAW may be obtained via the
Internet at http://grants2.nih.gov/grants/olaw/references/phspol.htm
 
ARTICLE H.7. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE
 
Anyone who becomes aware of the existence or apparent existence of fraud, waste
and abuse in BARDA funded programs should report such matters to the HHS
Inspector General's Office in writing or on the Inspector General's Hotline. The
toll free number is 1-800-HHS-TIPS (1-800­447-8477). All telephone calls will be
handled confidentially. The e-mail address is Htips@os.dhhs.gov and the mailing
address is:
 
Office of Inspector General
Department of Health and Human Services
TIPS HOTLINE
P.O. Box 23489
Washington, D.C. 20026
 
ARTICLE H.8. PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST ACTIVITIES
 
The Contractor acknowledges that U.S. Executive Orders and Laws, including but
not limited to E.O. 13224 and P.L. 107-56, prohibit transactions with, and the
provision of resources and support to, individuals and organizations associated
with terrorism. It is the legal responsibility of the Contractor to ensure
compliance with these Executive Orders and Laws. This clause must be included in
all subcontracts issued under this contract.
 
ARTICLE H.9. IDENTIFICATION AND DISPOSITION OF DATA
 
The Contractor will be required to provide certain data generated under this
contract to the Department of Health and Human Services (DHHS). DHHS reserves
the right to review any other data determined by DHHS to be relevant to this
contract. The contractor shall keep copies of all data required by the Food and
Drug Administration (FDA) relevant to this contract for the time specified by
the FDA.
 
ARTICLE H.10. EXPORT CONTROL NOTIFICATION
 
Contractors are responsible for ensuring compliance with all export control laws
and regulations that may be applicable to the export of and foreign access to
their proposed technologies. Contractors may consult with the Department of
State with any questions regarding the International Traffic in Arms Regulation
(ITAR) (22 CRF Parts 120-130) and /or the Department of Commerce regarding the
Export Administration Regulations (15 CRF Parts 730-774).

 
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ARTICLE H.11. CONFLICT OF INTEREST
 
The Contractor represents and warrants that, to the best of the Contractor's
knowledge and belief, there are no relevant facts or circumstances which could
give rise to an organizational conflict of interest, as defined in FAR 2.101 and
Subpart 9.5, or that the Contractor has disclosed all such relevant information.
Prior to commencement of any work, the Contractor agrees to notify the
Contracting Officer promptly that, to the best of its knowledge and belief, no
actual or potential conflict of interest exists or to identify to the
Contracting Officer any actual or potential conflict of interest the firm may
have. In emergency situations, however, work may begin but notification shall be
made within five (5) working days. The Contractor agrees that if an actual or
potential organizational conflict of interest is identified during performance,
the Contractor shall promptly make a full disclosure in writing to the
Contracting Officer. This disclosure shall include a description of actions
which the Contractor has taken or proposes to take, after consultation with the
Contracting Officer, to avoid, mitigate, or neutralize the actual or potential
conflict of interest. The Contractor 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.12. INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL
CONFLICTS OF INTEREST
 
The Institution (includes any contractor, public or private, excluding a Federal
agency) shall comply with the requirements of 45 CFR Part 94, Responsible
Prospective Contractors, which promotes objectivity in research by establishing
standards to ensure that Investigators (defined as the project director or
principal Investigator and any other person, regardless of title or position,
who is responsible for the design, conduct, or reporting of research funded
under BARDA contracts, or proposed for such funding, which may include, for
example, collaborators or consultants) will not be biased by any Investigator
financial conflicts of interest.
 
If the failure of an Institution to comply with an Institution's financial
conflicts of interest policy or a financial conflict of interest management plan
appears to have biased the design, conduct, or reporting of the BARDA-funded
research, the Institution must promptly notify the Contracting Officer of the
corrective action taken or to be taken. The Contracting Officer will consider
the situation and, as necessary, take appropriate action or refer the matter to
the Institution for further action, which may include directions to the
Institution on how to maintain appropriate objectivity in the BARDA-funded
research project.
 
The Contracting Officer and/or HHS may inquire at any time before, during, or
after award into any Investigator disclosure of financial interests, and the
Institution's review of, and response to, such disclosure, regardless of whether
the disclosure resulted in the Institution's determination of a financial
conflict of interests. The Contracting Officer may require submission of the
records or review them on site. On the basis of this review of records or other
information that may be available, the Contracting Officer may decide that a
particular financial conflict of interest will bias the objectivity of the
BARDA-funded research to such an extent that further corrective action is needed
or that the Institution has not managed the financial conflict of interest in
accordance with Part 94.6(b). The issuance of a Stop Work Order by the
Contracting Officer may be necessary until the matter is resolved.
 
If the Contracting Officer determines that BARDA-funded clinical research, whose
purpose is to evaluate the safety or effectiveness of a drug, medical device, or
treatment, has been designed, conducted, or reported by an Investigator with a
financial conflict of interest that was managed or reported by the Institution,
the Contracting Officer shall require the Investigator involved to disclose the
financial conflict of interest in each public presentation of the results of the
research and to request an addendum to previously published presentations.
 
 
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ARTICLE H.13. NEEDLE DISTRIBUTION
 
The Contractor shall not use contract funds to carry out any program of
distributing sterile needles or syringes for the hypodermic injection of any
illegal drug.
 
ARTICLE H.14. RESTRICTION ON ABORTIONS
 
The Contractor shall not use contract funds for any abortion.
 
ARTICLE H.15. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH
 
The Contractor shall not use contract funds for (1) the creation of a human
embryo or embryos for research purposes; or (2) research in which a human embryo
or embryos are destroyed, discarded, or knowingly subjected to risk of injury or
death greater than that allowed for research on fetuses in utero under 45 CFR
46.204(b) and Section 498(b) of the Public Health Service Act (42 U.S.C.
289g(b)). The term "human embryo or embryos" includes any organism, not
protected as a human subject under 45 CFR 46 as of the date of the enactment of
this Act, that is derived by fertilization, parthenogenesis, cloning, or any
other means from one or more human gametes or human diploid cells.
 
Additionally, in accordance with a March 4, 1997 Presidential Memorandum,
Federal funds may not be used for cloning of human beings.
 
ARTICLE H.16. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION
 
The Contractor shall not use contract funds to disseminate information that is
deliberately false or misleading.
 
ARTICLE H.17. CONFIDENTIALITY OF INFORMATION
 
 
a.
Confidential information, as used in this article, means information or data of
a personal nature about an individual, or proprietary information or data
submitted by or pertaining to an institution or organization.

 
 
b.
The Contracting Officer and the Contractor may, by mutual consent, identify
elsewhere in this contract specific information and/or categories of information
which the Government will furnish to the Contractor or that the Contractor is
expected to generate which is confidential. Similarly, the Contracting Officer
and the Contractor may, by mutual consent, identify such confidential
information from time to time during the performance of the contract. Failure to
agree will be settled pursuant to the "Disputes" clause.

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

 
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d.
Confidential information, as defined in paragraph (a) of this article, shall not
be disclosed without the prior written consent of the individual, institution,
or organization.

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

 
 
f.
Contracting Officer determinations will reflect the result of internal
coordination with appropriate program and legal officials.

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

 
ARTICLE H.18. ACCESS TO DOCUMENTATION/DATA
 
The Government shall have physical and electronic access to all documentation
and data generated under this contract, including: all data documenting Offeror
performance; all data generated; all communications and correspondence with
regulatory agencies and bodies to include all audit observations, inspection
reports, milestone completion documents, and all Offeror commitments and
responses. Offeror shall provide the Government with an electronic copy of all
correspondence with the FDA within 24 hours of receipt. The Government shall
acquire unlimited rights to all data funded under a contract awarded in response
to this RFP in accordance with FAR Subpart 27.4 and FAR Clause 52.227-14.
 
ARTICLE H.19. DISSEMINATION OF INFORMATION
 
No information related to data obtained under this contract shall be released or
publicized without the prior written notice to the Contracting Officer, whose
response shall not be unreasonably withheld, conditioned, or delayed, provided
that no such consent is required to comply with any law, rule, regulation, court
ruling or similar order; for submission to any Government entity’ for submission
to any securities exchange on which the Offeror’s (or its parent corporation’s)
securities may be listed for trading; or to third parties relating to securing,
seeking, establishing or maintaining regulatory or other legal approvals or
compliance, financing and capital raising activities, or mergers, acquisitions,
or other business transactions.
 
ARTICLE H.20. 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.

 
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ARTICLE H.21. 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.

 
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 BARDA COR review no less
than fourteen (14) calendar days for manuscripts and seven (7) 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.
HHSO100201300023C.”
 
C.
Press Releases

 
 
(1)
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) if applicable, the percentage and dollar amount of the total
costs of the project or program that will be financed by nongovernmental
sources.

 
 
(2)
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.

 
H.22. IN-PROCESS REVIEW
 
In Process Reviews (IPR) will be conducted at the discretion of the Government
to discuss the progression of the milestones. The Government reserves the right
to revise the milestones and budget pending the development of the project.
Deliverables may be required when the IPRs are conducted. The Contractor’s
success in completing the required tasks under each work segment must be
demonstrated through the Deliverables and Milestones specified under SECTION F.

 
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Those deliverables will constitute the basis for the Government’s decision, at
its sole discretion, to proceed with the work segment, or unilaterally institute
changes to the work segment, or terminate the work segment.
 
IPRs may be scheduled at the discretion of the Government to discuss progression
of the contract. The Contractor shall provide a presentation following a
prescribed template which will be provided by the Government at least 30 days
prior to the IPR. The contractor shall provide a draft presentation to the
Contracting Officer at least 10 days prior to the IPR.
 
ARTICLE H.23. PROHIBITION ON THE USE OF APPROPRIATED FUNDS FOR LOBBYING
ACTIVITIES AND HHSAR 352.203-70 ANTI-LOBBYING (March 2012)
 
The Contractor is hereby notified of the restrictions on the use of Department
of Health and Human Service's funding for lobbying of Federal, State and Local
legislative bodies.
 
Section 1352 of Title 10, United Stated Code (Public Law 101-121, effective
12/23/89), among other things, prohibits a recipient (and their subcontractors)
of a Federal contract, grant, loan, or cooperative agreement from using
appropriated funds (other than profits from a federal contract) to pay any
person for influencing or attempting to influence an officer or employee of any
agency, a Member of Congress, an officer or employee of Congress, or an employee
of a Member of Congress in connection with any of the following covered Federal
actions; the awarding of any Federal contract; the making of any Federal grant;
the making of any Federal loan; the entering into of any cooperative agreement;
or the modification of any Federal contract, grant, loan, or cooperative
agreement. For additional information of prohibitions against lobbying
activities, see FAR Subpart 3.8 and FAR Clause 52.203-12.
 
In addition, as set forth in HHSAR 352.203-70 “Anti-Lobbying” (March 2012), the
current Department of Health and Human Services Appropriations Act provides that
no part of any appropriation contained in this Act shall be used, other than for
normal and recognized executive-legislative relationships, for publicity or
propaganda purposes, for the preparation, distribution, or use of any kit,
pamphlet, booklet, publication, radio, television, or video presentation
designed to support, or defeat legislation pending before the Congress, or any
State or Local legislature except in presentation to the Congress, or any State
or Local legislative body itself.
 
The current Department of Health and Human Services Appropriations Act also
provides that no part of any appropriation contained in this Act shall be used
to pay the salary or expenses of any contract or grant recipient, or agent
acting for such recipient, related to any activity designed to influence
legislation or appropriations pending before the Congress, or any State or Local
legislature.
 
ARTICLE H.24. PRIVACY ACT APPLICABILITY
 
1)
Notification is hereby given that the Contractor and its employees are subject
to criminal penalties for violation of the Privacy Act to the same extent as
employees of the Government. The Contractor shall assure that each of its
employees knows the prescribed rules of conduct and that each is aware that he
or she can be subjected to criminal penalty for violation of the Act. A copy of
45 CFR Part 5b, Privacy Act Regulations, may be obtained at
http://www.gpoaccess.gov/cfr/index.html

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

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

 
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ARTICLE H.25. LABORATORY LICENSE REQUIREMENTS
 
The Contractor shall comply with all applicable requirements of Section 353 of
the Public Health Service Act (Clinical Laboratory Improvement Act as amended).
This requirement shall also be included in any subcontract for services under
the contract.
 
ARTICLE H.26. QA AUDIT REPORTS
 
BARDA reserves the right to participate in QA audits. Upon completion of the
audit/site visit the Contractor shall provide a report capturing the findings,
results and next steps in proceeding with the subcontractor. If action is
requested of the subcontractor, detailed concerns for addressing areas of
non-conformance to FDA regulations for GLP, GMP, or GCP guidelines, as
identified in the audit report, must be provided to BARDA. The Contractor shall
provide responses from the subcontractors to address these concerns and plans
for corrective action execution.
 
 
·
Contractor shall notify CO and COR of upcoming, ongoing, or recent audits/site
visits of subcontractors as part of weekly communications. The Contractor shall
notify the CO and COR reasonably in advance of upcoming QA audit so that
Government personnel may participate in person at BARDA’s discretion.

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

 
ARTICLE H.27. BARDA AUDITS
 
Contractor shall accommodate periodic or ad hoc site visits by the Government.
If the Government, the Contractor, or other parties identifies any issues during
an audit, the Contractor shall capture the issues, identify potential solutions,
and provide a report to the Government.
 
 
·
If issues are identified during the audit, Contractor shall submit a report to
the CO and COR detailing the finding and corrective action(s) within 10 business
days of the audit.

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

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

 
ARTICLE H.28. SECURITY REPORTING REQUIREMENT
 
Violations of established security protocols shall be reported to the CO and COR
upon discovery within 24 hours of its receipt of any compromise, intrusion, loss
or interference of its security processes and procedures. The Contractor shall
ensure that all software components that are not required for the operation and
maintenance of the database/control system have been removed and/or disabled.
The Contractor shall provide to the CO and the COR information appropriate to
Information and Information Technology software and service updates and/or
workarounds to mitigate all vulnerabilities associated with the data and shall
maintain the required level of system security.
 
The Contractor will investigate violations to determine the cause, extent, loss
or compromise of sensitive program information, and corrective actions taken to
prevent future violations. The CO in coordination with BARDA will determine the
severity of the violation. Any contractual actions resulting from the violation
will be determined by the CO.

 
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PART II - CONTRACT CLAUSES SECTION I - CONTRACT CLAUSES
 
ARTICLE I.1. FAR 52.252-2, CLAUSES INCORPORATED BY REFERENCE (FEBRUARY 1998)
 
This contract incorporates the following clauses by reference, with the same
force and effect as if they were given in full text. Upon request, the
Contracting Officer will make their full text available. Also, the full text of
a clause may be accessed electronically at these addresses:
https://www.acquisition.gov/FAR/ . HHSAR Clauses at:
http://www.hhs.gov/policies/hhsar/subpart352.html.
 
General Clauses for Cost-Reimbursement Research and Development Contract
 
(1)           FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:

FAR CLAUSE
 
DATE
 
TITLE
52.202-1
 
Jan 2012
 
Definitions
52.203-3
 
Apr 1984
 
Gratuities
52.203-5
 
Apr 1984
 
Covenant Against Contingent Fees
52.203-6
 
Sep 2006
 
Restrictions on Subcontractor Sales to the Government
52.203-7
 
Oct 2010
 
Anti-Kickback Procedures
52.203-8
 
Jan 1997
 
Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity
52.203-10
 
Jan 1997
 
Price or Fee Adjustment for Illegal or Improper Activity
52.203-12
 
Oct 2010
 
Limitation on Payments to Influence Certain Federal Transactions
52.203-13
 
Apr 2010
 
Contractor Code of Business Ethics and Conduct
52.203-14
 
Dec 2007
 
Display of Hotline Posters.
52.204-4
 
May 2011
 
Printed or Copied Double-Sided on Recycled Paper
52.204-7
 
Jul 2013
 
System for Award management
52.204-10
 
Aug 2012
 
Reporting Executive Compensation and First-Tier Subcontract awards
52.204-13
 
Jul 2013
 
System for Award Maintenance
52.209-6
 
Aug 2013
 
Protecting the Government’s Interests When Subcontracting With Contractors
Debarred, Suspended, or Proposed for Debarment
52.209-9
 
Feb 2012
 
Updates of Publicly Available Information Regarding Responsibility Matters
52.210-1
 
Apr 2011
 
Market Research
52.215-2
 
Oct 2010
 
Audit and Records – Negotiation

 
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52.215-8
 
Oct 1997
 
Order of Precedence - Uniform Contract Format
52.215-10
 
Aug 2011
 
Price Reduction for Defective Certified Cost or Pricing Data
52.215-12
 
Oct 2010
 
Subcontractor Certified Cost or Pricing Data
52.215-15
 
Oct 2010
 
Pension Adjustments and Asset Reversions
52.215-18
 
Jul 2005
 
Reversion or Adjustment of Plans for Post-Retirement Benefits (PRB) other than
Pensions
52.215-19
 
Oct 1997
 
Notification of Ownership Changes
52.215-21
 
Oct 2010
 
Requirements for Certified Cost or Pricing Data and Data Other Than Certified
Cost or Pricing Data – Modifications
52.215-23
 
Oct 2009
 
Limitations on Pass-Through Charges
52.216-7
 
Jun 2013
 
Allowable Cost and Payment
52.216-8
 
Jun 2011
 
Fixed Fee
52.219-8
 
Jan 2011
 
Utilization of Small Business Concerns
52.219-9
 
Jan 2011
 
Small Business Subcontracting Plan, Alternate II
52.219-28
 
Jul 2013
 
Post-Award Small Business Program Representation
52.222-2
 
Jul 1990
 
Payment for Overtime Premiums
52.222-3
 
Jun 2003
 
Convict Labor
52.222-21
 
Feb 1999
 
Prohibition of Segregated Facilities
52.222-26
 
Mar 2007
 
Equal Opportunity
52.222-35
 
Sep 2010
 
Equal Opportunity for Veterans
52.222-36
 
Oct 2010
 
Affirmative Action for Workers with Disabilities
52.222-37
 
Sep 2010
 
Employment Reports on Veterans
52.222-40
 
Dec 2010
 
Notification of Employee Rights Under the National Labor Relations Act
52.222-50
 
Feb 2009
 
Combating Trafficking in Persons
52.222-54
 
Aug 2013
 
Employment Eligibility Verification
52.223-6
 
May 2001
 
Drug-Free Workplace
52.223-18
 
Aug 2011
 
Encouraging Contractor Policies to Ban Text Messaging While Driving
52.224-1
 
April 1984
 
Privacy Act Notification
52.224-2
 
April 1984
 
Privacy Act
52.225-13
 
Jun 2008
 
Restrictions on Certain Foreign Purchases

 
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52.227-1
 
Dec 2007
 
Authorization and Consent, Alternate I
52.227-2
 
Dec 2007
 
Notice and Assistance Regarding Patent and Copyright Infringement
52.227-11
 
Dec 2007
 
Patent Rights - Ownership by the Contractor (Note: In accordance with FAR
27.303(b)(2), paragraph (e) is modified to include the requirements in FAR
27.303(b)(2)(i) through (iv). The frequency of reporting in (i) is annual.
52.227-14
 
Dec 2007
 
Rights in Data – General, Alternate II
       
Completed portion as follows:
       
Limited Rights Notice (Dec 2007)
       
(a) These data are submitted with limited rights under Government Contract No.
HHSO100201300023C. These data may be reproduced and used by the Government with
the express limitation that they will not, without written permission of the
Contractor, be used for purposes of manufacture nor disclosed outside the
Government; except that the Government may disclose these data outside the
Government for the following purposes, provided that the Government makes such
disclosure subject to prohibition against further use and disclosure:
 

       
(i)           Use (except for manufacture) by support service contractors.
(ii)          Evaluation by nongovernment evaluators.
 
(b) This Notice shall be marked on any reproduction of these data, in whole or
in part.
52.232-9
 
Apr 1984
 
Limitation on Withholding of Payments
52.232-17
 
Oct 2010
 
Interest
52.232-20
 
Apr 1984
 
Limitation of Cost
52.232-23
 
Jan 1986
 
Assignment of Claims
52.232-25
 
Jul 2013
 
Prompt Payment Alternate I (Feb 2002)
52.232-33
 
Jul 2013
 
Payment by Electronic Funds Transfer-System for Award Management
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
52.234-4
 
Jul 2006
 
Earned Value Management System
52.242-1
 
Apr 1984
 
Notice of Intent to Disallow Costs
52.242-3
 
May 2001
 
Penalties for Unallowable Costs
52.242-4
 
Jan 1997
 
Certification of Final Indirect Costs
52.242-13
 
Jul 1995
 
Bankruptcy
52.242-15
 
Aug 1989
 
Stop Work Order, Alternate I (Aug 1984)

 
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52.243-2
 
Aug 1987
 
Changes - Cost Reimbursement, Alternate V (Apr 1984)
52.244-2
 
June 2007
 
Subcontracts, Alternate I
52.244-5
 
Dec 1996
 
Competition in Subcontracting
52.244-6
 
Dec 2010
 
Subcontracts for Commercial Items
52.245-1 Alt. II
 
Apr 2012
 
Government Property, Alternate II
52.245-9
 
Apr 2012
 
Use and Charges
52.246-23
 
Feb 1997
 
Limitation of Liability
52.246-25
 
Feb 1997
 
Limitation of Liability – Services
52.247-63
 
Jun 2003
 
Preference for U.S.-Flag Air Carriers
52.247-67
 
Feb 2006
 
Submission of Transportation Documents for Audit
52.249-6
 
May 2004
 
Termination (Cost-Reimbursement)
52-249-14
 
Apr 1984
 
Excusable Delays
52.251-1
 
Apr 2012
 
Government Supply Sources
52.253-1
 
Jan 1991
 
Computer Generated Forms

 
(2) DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48
CFR CHAPTER 3) CLAUSES:
 
HHSAR CLAUSE NO.
 
DATE
 
TITLE
352.201-70
 
Jan 2006
 
Paperwork Reduction Act
352.202-1
 
Jan 2006
 
Definitions, with Alternate paragraph (h)
352.203-70
 
Mar 2012
 
Anti-Lobbying
352.216-70
 
Jan 2006
 
Additional Cost Principles
352.222-70
 
Jan 2010
 
Contractor Cooperation in Equal Employment Opportunity Investigations
352.223-70
 
Jan 2006
 
Safety and Health
352.224-70
 
Jan 2006
 
Privacy Act
352.227-70
 
Jan 2006
 
Publications and Publicity
352.228-7
 
Dec 1991
 
Insurance - Liability to Third Persons
352.231-70
 
Mar 2012
 
Salary Rate Limitation
352.231-71
 
Jan 2001
 
Pricing of Adjustments

 
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352.233-71
 
Jan 2006
 
Litigation and Claims
352.234-3
 
Oct 2008
 
Full Earned Value Management System
352.242-70
 
Jan 2006
 
Key Personnel
352.242-73
 
Jan 2006
 
Withholding of Contract Payments
352.242-74
 
Apr 1984
 
Final Decisions on Audit Findings
352.270-4
 
Jan 2006
 
Protection of Human Subjects
352.270-6
 
Jan 2006
 
Restrictions on Use of Human Subjects

 
ARTICLE I.2. ADDITIONAL CONTRACT CLAUSES
 
This contract incorporates the following clauses by reference, with the same
force and effect, as if they were given in full text. Upon request, the
Contracting Officer will make their full text available.
 
a. FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES
 
1.      FAR 52.215-17, Waiver of Facilities Capital Cost of Money (October
1997).
2.      FAR 52.227-16, Additional Data Requirements (June 1987).
 
b. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48
CHAPTER 3) CLAUSES:
 
1. HHSAR 352.201-70, Paperwork Reduction Act (January 2006).
 
ARTICLE I.3. ADDITIONAL FAR CLAUSES INCLUDED IN FULL TEXT
 
FAR 52.217-9 Option to Extend the Term of the Contract
 
OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)
 
(a) The Government may extend the term of this contract by written notice to the
Contractor within 30 days; provided that the Government gives the Contractor a
preliminary written notice of its intent to extend at least 60 days before the
contract expires. The preliminary notice does not commit the Government to an
extension.
 
(b) If the Government exercises this option, the extended contract shall be
considered to include this option clause.
 
(c) The total duration of this contract, including the exercise of any options
under this clause, shall not exceed 5 years.
 
FAR 52.219-1 Small Business Program Representations
 
SMALL BUSINESS PROGRAM REPRESENTATIONS (MAY 2004)
 
(a)   (1) The North American Industry Classification System (NAICS) code for
this acquisition is 541711.
 
 
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(2) The small business size standard is 500 employees.
 
(3) The small business size standard for a concern which submits an offer in its
own name, other than on a construction or service contract, but which proposes
to furnish a product which it did not itself manufacture, is 500 employees.
 
(b) Representations.
 
(1) The offeror represents as part of its offer that it [X] is, [_] is not a
small business concern.
 
(2) [Complete only if the offeror represented itself as a small business concern
in paragraph (b)(1) of this provision.] The offeror represents, for general
statistical purposes, that it [_] is, [X] is not, a small disadvantaged business
concern as defined in 13 CFR 124.1002.
 
(3) [Complete only if the offeror represented itself as a small business concern
in paragraph (b)(1) of this provision.] The offeror represents as part of its
offer that it [ ] is, [X] is not a women-owned small business concern.
 
(4) Women-owned small business (WOSB) concern eligible under the WOSB Program.
[Complete only if the offeror represented itself as a women-owned small business
concern in paragraph (b)(3) of this provision.] The offeror represents as part
of its offer that—
 
(i)  It [_] is, [X] is not a WOSB concern eligible under the WOSB Program, has
provided all the required documents to the WOSB Repository, and no change in
circumstances or adverse decisions have been issued that affects its
eligibility; and
 
(ii) It [_] is, [X] is not a joint venture that complies with the requirements
of 13 CFR part 127, and the representation in paragraph (b)(4)(i) of this
provision is accurate for each WOSB concern eligible under the WOSB Program
participating in the joint venture. [The offeror shall enter the name or names
of the WOSB concern eligible under the WOSB Program and other small businesses
that are participating in the joint venture:__________ .] Each WOSB concern
eligible under the WOSB Program participating in the joint venture shall submit
a separate signed copy of the WOSB representation.
 
(5) Economically disadvantaged women-owned small business (EDWOSB) concern.
[Complete only if the offeror represented itself as a women-owned small business
concern eligible under the WOSB Program in (b)(4) of this provision.] The
offeror represents as part of its offer that--
 
(i)  It [_] is, [X] is not an EDWOSB concern eligible under the WOSB Program,
has provided all the required documents to the WOSB Repository, and no change in
circumstances or adverse decisions have been issued that affects its
eligibility; and
 
(ii) It [_] is, [X] is not a joint venture that complies with the requirements
of 13 CFR part 127, and the representation in paragraph (b)(5)(i) of this
provision is accurate for each EDWOSB concern participating in the joint
venture. [The offeror shall enter the name or names of the EDWOSB concern and
other small businesses that are participating in the joint
venture:______________.] Each EDWOSB concern participating in the joint venture
shall submit a separate signed copy of the EDWOSB representation.
 
 
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(6) [Complete only if the offeror represented itself as a small business concern
in paragraph (b)(1) of this provision.] The offeror represents as part of its
offer that it [_] is, [X] is not a veteran-owned small business concern.
 
(7) [Complete only if the offeror represented itself as a veteran-owned small
business concern in paragraph (b)(6) of this provision.] The offeror represents
as part of its offer that is [_] is, [X] is not a service-disabled veteran-owned
small business concern.
 
(8) [Complete only if the offeror represented itself as a small business concern
in paragraph (b)(1) of this provision.] The offeror represents, as part of its
offer, that –
 
(i)  It [_] is, [X] is not a HUBZone small business concern listed, on the date
of this representation, on the List of Qualified HUBZone Small Business Concerns
maintained by the Small Business Administration, and no material changes in
ownership and control, principal office, or HUBZone employee percentage have
occurred since it was certified in accordance with 13 CFR part 126; and
 
(ii) It [_] is, [X] is not a HUBZone joint venture that complies with the
requirements of 13 CFR part 126, and the representation in paragraph (b)(8)(i)
of this provision is accurate for each HUBZone small business concern
participating in the HUBZone joint venture. [The offeror shall enter the names
of each of the HUBZone small business concerns participating in the HUBZone
joint venture:___________ .] Each HUBZone small business concern participating
in the HUBZone joint venture shall submit a separate signed copy of the HUBZone
representation.
 
(c) Definitions. As used in this provision--
 
“Economically disadvantaged women-owned small business (EDWOSB) concern” means a
small business concern that is at least 51 percent directly and unconditionally
owned by, and the management and daily business operations of which are
controlled by, one or more women who are citizens of the United States and who
are economically disadvantaged in accordance with 13 CFR part 127. It
automatically qualifies as a women-owned small business concern eligible under
the WOSB Program.
 
 “Service-disabled veteran-owned small business concern”—
 
(1) Means a small business concern—
 
(i) Not less than 51 percent of which is owned by one or more service-disabled
veterans or, in the case of any publicly owned business, not less than 51
percent of the stock of which is owned by one or more service-disabled veterans;
and
 
(ii) The management and daily business operations of which are controlled by one
or more service-disabled veterans or, in the case of a service-disabled veteran
with permanent and severe disability, the spouse or permanent caregiver of such
veteran.
 
 
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(2) Service-disabled veteran means a veteran, as defined in 38 U.S.C. 101(2),
with a disability that is service-connected, as defined in 38 U.S.C. 101(16).
 
“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 (a) of
this provision.
 
“Veteran-owned small business concern” means a small business concern—
 
(1) Not less than 51 percent of which is owned by one or more veterans (as
defined at 38 U.S.C. 101(2)) or, in the case of any publicly owned business, not
less than 51 percent of the stock of which is owned by one or more veterans; and
 
(2) The management and daily business operations of which are controlled by one
or more veterans.
 
“Women-owned small business concern,” means a small business concern --
 
(1) That is at least 51 percent owned by one or more women; or, in the case of
any publicly owned business, at least 51 percent of the stock of which is owned
by one or more women; and
 
(2) Whose management and daily business operations are controlled by one or more
women.
 
“Women-owned small business (WOSB) concern eligible under the WOSB Program (in
accordance with 13 CFR part 127),” means a small business concern that is at
least 51 percent directly and unconditionally owned by, and the management and
daily business operations of which are controlled by, one or more women who are
citizens of the United States.
 
(d) Notice.
 
(1) If this solicitation is for supplies and has been set aside, in whole or in
part, for small business concerns, then the clause in this solicitation
providing notice of the set-aside contains restrictions on the source of the end
items to be furnished.
 
(2) Under 15 U.S.C. 645(d), any person who misrepresents a firm’s status as a
business concern that is small, HUBZone small, small disadvantaged,
service-disabled veteran-owned small, economically disadvantaged women-owned
small, or women-owned small eligible under the WOSB Program in order to obtain a
contract to be awarded under the preference programs established pursuant to
section 8, 9, 15, 31, and 36 of the Small Business Act or any other provision of
Federal law that specifically references section 8(d) for a definition of
program eligibility, shall --
 
(i)   Be punished by imposition of fine, imprisonment, or both;
 
(ii)  Be subject to administrative remedies, including suspension and debarment;
and
 
(iii) Be ineligible for participation in programs conducted under the authority
of the Act.

 
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FAR 52.219-28, Post-Award Small Business Program Representation
 
POST-AWARD SMALL BUSINESS PROGRAM REPRESENTATION (JUL 2013)
 
(a) Definitions . As used in this clause--
 
Long-term contract means a contract of more than five years in duration,
including options. However, the term does not include contracts that exceed five
years in duration because the period of performance has been extended for a
cumulative period not to exceed six months under the clause at 52.217-8, Option
to Extend Services, or other appropriate authority.
 
Small business concern means a concern, including its affiliates, which is
independently owned and operated, not dominant in the field of operation in
which it is bidding on Government contracts, and qualified as a small business
under the criteria in 13 CFR part 121 and the size standard in paragraph (c) of
this clause. Such a concern is "not dominant in its field of operation" when it
does not exercise a controlling or major influence on a national basis in a kind
of business activity in which a number of business concerns are primarily
engaged. In determining whether dominance exists, consideration shall be given
to all appropriate factors, including volume of business, number of employees,
financial resources, competitive status or position, ownership or control of
materials, processes, patents, license agreements, facilities, sales territory,
and nature of business activity.
 
(b) If the Contractor represented that it was a small business concern prior to
award of this contract, the Contractor shall represent its size status according
to paragraph (e) of this clause or, if applicable, paragraph (g) of this clause,
upon the occurrence of any of the following:
 
(1) Within 30 days after execution of a novation agreement or within 30 days
after modification of the contract to include this clause, if the novation
agreement was executed prior to inclusion of this clause in the contract.
 
(2) Within 30 days after a merger or acquisition that does not require a
novation or within 30 days after modification of the contract to include this
clause, if the merger or acquisition occurred prior to inclusion of this clause
in the contract.
 
(3) For long-term contracts--
 
(i) Within 60 to 120 days prior to the end of the fifth year of the contract;
and
 
(ii) Within 60 to 120 days prior to the date specified in the contract for
exercising any option thereafter.
 
(c) The Contractor shall represent its size status in accordance with the size
standard in effect at the time of this representation that corresponds to the
North American Industry Classification System (NAICS) code assigned to this
contract. The small business size standard corresponding to this NAICS code can
be found at
http://www.sba.gov/contractingopportunities/officials/size/index.html.

 
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 (d) The small business size standard for a Contractor providing a product which
it does not manufacture itself, for a contract other than a construction or
service contract, is 500 employees.
 
(e) Except as provided in paragraph (g) of this clause, the Contractor shall
make the representation required by paragraph (b) of this clause by validating
or updating all its representations in the Online Representations and
Certifications Application and its data in the Central Contractor Registration,
as necessary, to ensure that they reflect the Contractor's current status. The
Contractor shall notify the contracting office in writing within the timeframes
specified in paragraph (b) of this clause that the data have been validated or
updated, and provide the date of the validation or update.
 
(f) If the Contractor represented that it was other than a small business
concern prior to award of this contract, the Contractor may, but is not required
to, take the actions required by paragraphs (e) or (g) of this clause.
 
(g) If the Contractor does not have representations and certifications in ORCA,
or does not have a representation in ORCA for the NAICS code applicable to this
contract, the Contractor is required to complete the following representation
and submit it to the contracting office, along with the contract number and the
date on which the representation was completed:
 
The Contractor represents that it [X] is, [ ] is not a small business concern
under NAICS Code 541711 assigned to contract number HHSO100201300023C.
 
            FAR 52.232-99, Providing Accelerated Payment to Small Business
Subcontractors (DEVIATION)
 
PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS (DEVIATION) (AUG
2013)
 
This clause implements the temporary policy provided by OMB Policy Memorandum
M-12­16, Providing Prompt Payment to Small Business Subcontractor, dated July
11, 2012, and the extension to that policy provided by OMB Policy Memorandum
M-13-15, Extension of Policy to Provide Accelerated Payment to Small Business
Subcontractors, dated July 11, 2013.
 
     (a)   Upon receipt of accelerated payments from the Government, the
contractor is required to make accelerated payments to small business
subcontractors to the maximum extent practicable after receipt of a proper
invoice and all proper documentation from the small business subcontractor.
 
     (b)   Include the substance of this clause, including this paragraph (b),
in all subcontracts with small business concerns.
 
     (c)   The acceleration of payments under this clause does not provide any
new rights under the Prompt payment Act

 
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PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS
 
SECTION J - LIST OF ATTACHMENTS
 
 
The following documents are attached and incorporated in this contract:

 
 
1.
Statement of Work, dated August 22, 2013, 8 pages

 
 
2.
Milestone and Deliverables Chart, dated August, 2013, 5 pages

 
 
3.
Work Breakdown Structure Gantt Chart, dated August 22, 2013, 3 pages

 
 
4.
Financial Report of Individual Project/Contract, 1 page

 
 
5.
Instructions for Completing Financial Report of Individual Project/Contract, 3
pages

 
 
6.
Invoice/Financing Request Instructions and Contract Financial Reporting
Instructions for BARDA Cost-Reimbursement Type Contracts, 8 pages

 
 
7.
Form SF-LLL, Disclosure of Lobbying Activities, 2 pages

 
 
8.
Report of Government Owned, Contractor Held Property, 1 page, available at
http://rcb.cancer.gov/rcb-internet/forms/Govt-Owned-Prop.pdf

 
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 on the System for Award
Management (SAM) website.
 
2)   Animal Welfare Assurance Numbers (OLAW/PHS):
 
[****]
 
End of Contract No. HHSO100201300023C

 
Portions herein identified by [*****] have been omitted pursuant to a request
for confidential treatment under Rule 24b-2 of the Securities Exchange Act of
1934, as amended. A complete copy of this document has been filed separately
with the Securities and Exchange Commission.
 
 
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