Exhibit 10.3

AWARD/CONTRACT

1.  THIS CONTRACT IS A RATED ORDER

RATING

PAGE OF PAGES

   1    61

 UNDER DPAS (15 CFR 700)

2.  CONTRACT (Proc. Inst. Ident.) NO.

3.  EFFECTIVE DATE

4.  REQUISITION/PURCHASE REQUEST/PROJECT NO.

75A50120C00159

See Block 20C OS263097

5.  ISSUED BY

ASPR-BARDA

     CODE

ASPR-BARDA

200 Independence Ave.,

S.W. Room 640-G

Washington DC 20201

7.  NAME AND ADDRESS OF CONTRACTOR

8.  DELIVERY

      (No., street, country, State and ZIP Code)

          FOB ORIGIN        X

           ☐           ☐

MARINUS

9.  DISCOUNT FOR PROMPT PAYMENT

PHARMACEUTICALS INC

1564975

10.  SUBMIT INVOICES

Attn: MICHAEL

(4 copies unless otherwise specified) TO THE ADDRESS

MCNAMARA

MARINUS PHARMACEUTICALS, INC.

100 MATSONFORD RD

STE 304 RADNOR

PA 190874558

CODE

1564975

11.  SHIP TO/MARK FOR

CODE

HHS/OS/ASPR

200 C St SW

WASHINGTON DC 20201

13.  AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

14. ACCOUNTING AND APPROPRIATION DATA

              10 U.S.C. 2304 (c) ( )

X 41 U.S.C. 3304 (a) ( )

15A. ITEM NO

15B. SUPPLIES/SERVICES

QUANTITY UNIT

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Continued

15G. TOTAL AMOUNT OF CONTRACT$21,338,880.00

16. TABLE OF CONTENTS

(X)

SEC.

DESCRIPTION

PAGE(S)

(X)

SEC.

DESCRIPTION

PAGE(S)

PART I - THE SCHEDULE

PART II - CONTRACT CLAUSES

A

SOLICITATION/CONTRACT FORM

I

CONTRACT CLAUSES

B

SUPPLIES OR SERVICES AND PRICES/COSTS

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

C

DESCRIPTION/SPECS./WORK STATEMENT

J

LIST OF ATTACHMENTS

D

PACKAGING AND MARKING

PART IV - REPRESENTATIONS AND INSTRUCTIONS

E

INSPECTION AND ACCEPTANCE

K

REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

F

DELIVERIES OR PERFORMANCE

G

CONTRACT ADMINISTRATION DATA

L

INSTRS., CONDS., AND NOTICES TO OFFERORS

H

SPECIAL CONTRACT REQUIREMENTS

M

EVALUATION FACTORS FOR AWARD

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CONTRACTING OFFICER WILL COMPLETE ITEM 17 (SEALED-BID OR NEGOTIATED PROCUREMENT)
OR 18 (SEALED-BID PROCUREMENT) AS APPLICABLE

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

representations, certifications, and specifications, as are attached or
incorporated by reference herein. (Attachments are listed herein.)

18. X SEALED-BID AWARD (Contractor is not required to sign this document.) Your
bid on Solicitation Number ,

including the additions or changes made by you which additions or changes are
set forth in full above, is hereby accepted as to the items listed above and on
any continuation sheets. This award consummates the contract which consists of
the following documents: (a) the Government's solicitation and your bid, and (b)
this award/contract.

No further contractual document is necessary. (Block 18 should be checked only
when awarding a sealed-bid contract.)

19A. NAME AND TITLE OF SIGNER (Type or print)

20A. NAME OF CONTRACTING OFFICER

James P. Bowers

19B.

MARINUS PHARMACEUTICALS INC

1564975

BY /s/ Edward Smtih, Chief Financial Officer

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(Signature of person authorized to sign)

19C. DATE SIGNED

9/8/2020

20B. UNITED STATES OF AMERICA

BY /s/ James P. Bowers

(Signature of the Contracting Officer)

20C. DATE SIGNED

9/8/2020

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AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition is NOT usable

STANDARD FORM 26 (Rev. 3/2013)

Prescribed by GSA - FAR (48 CFR) 53.214(a)

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CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED

75A50120C00159

PAGEOF

2

61

ITEM NO.

(A)

SUPPLIES/SERVICES

(B)

QUANTITY

(C)

UNIT

(D)

UNIT PRICE

(E)

AMOUNT

(F)

Tax ID Number:20-0198082

DUNS Number:141007232

ASPR-20-03076 -- Base Period fund to Marinus Pharm

aceuti

als

-- Ganaxolo

e for the

Treatment of Status Epilepticus (SE)

Delivery: 08/03/2020

Appr. Yr.: 2020 CAN: 1992020 Object Class: 25106

FOB: Destination

1

ASPR-20-03076 -- Base Period fund to Marinus

21,338,880.0

Pharmaceuticals -- Ganaxolone for the Treatment

of Status Epilepticus (SE)

Obligated Amount: $21,338,880.00

NAME OF OFFEROR OR CONTRACTOR

MARINUS PHARMACEUTICALS INC 1564975

cn

0

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AUTHORIZED FOR LOCAL REPROPTIONAL FORM 336 (4-86)

Sponsored by GSA FAR (48 CFR) 53.110

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CONTRACT TABLE OF CONTENTS

PART I – THE SCHEDULE‌4

SECTION B – SUPPLIES OR SERVICES AND PRICE/COSTS‌4

SECTION C – DESCRIPTIONS/SPECIFICATIONS/WORK STATEMENT‌9

SECTION D – PACKAGING, MARKING, & SHIPPING‌11

SECTION E – INSPECTION AND ACCEPTANCE‌12

SECTION F – DELIVERIES OR PERFORMANCE‌13

SECTION G – CONTRACT ADMINISTRATION DATA‌33

SECTION H – SPECIAL CONTRACT REQUIREMENTS‌39

PART II – CONTRACT CLAUSES‌53

SECTION I – CONTRACT CLAUSES‌53

PART III – LIST OF DOCUMENTS, EXHIBITS, AND OTHER ATTACHMENTS‌61

SECTION J – LIST OF ATTACHMENTS‌61

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PART I – THE SCHEDULE

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The Pandemic and All Hazards Preparedness Act (PAHPA) of 2006 established the
Biomedical Advanced Research and Development Authority (BARDA) and was
reauthorized under the PAHPA of 2013 to support development and acquisition of
medical countermeasure (MCMs) to prevent or treat the medical consequences of
chemical, biological, radiological, and nuclear (CBRN) threats, pandemic
influenza (PI), and emerging infectious diseases (EID). These MCMs include
vaccines, therapeutics, diagnostics, and medical devices. Additionally, BARDA is
entrusted to foster innovation of technologies that enable better manufacturing,
testing, and utilization of these medical countermeasures.

Marinus Pharmaceuticals (Marinus) is developing an intravenous (IV) formulation
of the synthetic neurosteroid ganaxolone (GNX) as a treatment for status
epilepticus (SE) in patients who are refractory to second line anti-epileptic
drugs (AEDs). GNX is a positive GABA-A receptor modulator with a well- defined
anti-epileptic mechanism of action. GNX, like benzodiazepines, modulates
synaptic GABA-A receptors (γ-subunit containing receptors). However, GNX has
four key advantages over benzodiazepines: 1) Unlike benzodiazepines, GNX
modulates extrasynaptic GABA-A receptors (δ- subunit containing receptors); 2)
Unlike benzodiazepines, repeated GNX administration does not induce tolerance to
the anticonvulsant response; 3) There is greater separation between
anticonvulsant and sedating doses; and 4) A wider therapeutic window that allows
it to work at times when benzodiazepines are no longer effective.

Marinus proposes to complete the preclinical and clinical development activities
for IV GNX to support FDA approval. For this project Marinus will: 1) Complete
the scale up of the GNX drug substance (DS) and drug product (DP) to the
commercial scale; 2) Complete a Phase 3 efficacy and safety trial designed based
on FDA feedback in patients 12 years old and above with SE who are refractory to
2nd line AEDs;

3) Complete and file a New Drug Application (NDA) for IV GNX; 4) Complete
studies that confirm that IV GNX is an effective treatment for SE due chemical
nerve agent exposure using standard of care animal models; 5) Complete studies
to support and file a supplemental NDA (sNDA) for IV GNX use in patients younger
than 12 years of age; and 6) On-shore all manufacturing activities.

The Government has determined a Bona Fide Need for each non-severable discrete
work segment which will conclude upon the completion of a defined task or
defined tasks that provide(s) independent merit and value to the Government. The
Contractor's success in completing the required tasks under the work segments
must be demonstrated through the Deliverables and Milestones specified under
Article F of this contract. As set forth in the Contract WBS
Milestones/Deliverables and Technical Deliverables chart under Article F of this
contract, the GO/NO GO Contract Milestones and Decision Gates will constitute
the basis for the Government’s decision, at its sole discretion, to exercise any
follow-on option period(s).

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

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B.2BASE PERIOD

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1.The total estimated cost of the base period of this contract is
$84,048,150.00..

2.The Contractor shall maintain records of all contract costs (to include
contractor share) and such records shall be subject to FAR 52.215-2 (Oct 2010),
Audit and Records – Negotiation and incorporated by reference into the contract
in SECTION I.

3.The amount currently obligated will cover base performance of the contract
through September 1, 2022.

CLIN

Period of Performance

Supplies/Services

Government Share

Contractor Share

Total Estimated Cost

0001

9/15/2020 to

9/1/2022

Pre-clinical Efficacy in a nerve agent model; Phase 3 Clinical Trial; Pre-NDA
Meeting

$21,338,880 (52%)

$19,455,822 (48%)

$40,794,702

B.3.OPTION PERIODS

B.3.1COST REIMBURSMENT OPTIONS

a.The contract includes optional, cost reimbursement CLINs 0002, 0003, and 0004.
The Government may exercise Option Periods in accordance with FAR 52.217-9
Option to Extend the Term of the Contract (March 2000), as set forth in Section
I of the contract.

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

c.The Government may modify the contract unilaterally and require the contractor
to provide supplies and services for Option Periods listed below, in accordance
with FAR 52.217-9.

d.If the Government decides to exercise an option(s), the Government will
provide the Contractor a preliminary written notice of its intent as referenced
in the clause. Specific information regarding the time frame for this notice is
set forth in the OPTION CLAUSE Article in SECTION G of this contract. The
estimated cost of the contract will be increased as set forth below:

Option

CLIN

Period of Performance

Supplies/Services

Government Share

Contractor Share

Total Estimated Cost

1

0002

01/3/2022 –

06/30/2023

Option 1 Period: Juvenile Toxicology Studies; Status Epilepticus NDA submission

$11,330,470 (93%)

$895,175 (7%)

$12,225,645

2

0003

9/1/2022 –

12/31/2026

Option 2 Period: Completion of API On-shoring

$11,539,230 (70%)

$4,945,385 (30%)

$16,484,615

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3

0004

4/1/2023 –

11/1/2024

Option 3 Period: Pediatric Phase III Clinical Trial; sNDA submission

$7,271,594 (50%)

$7,271,594 (50%)

$14,543,188

TOTALS

Only option years

$30,141,294

$13,112,154

$43,253,448

TOTALS

Base + options

$51,480,174

$32,567,976

$84,048,150

B.4 ESTIMATED COST - COST SHARING

This is a cost-sharing contract. The total estimated BARDA cost sharing for
performing the work under this contract is $51,480,174 ( Base: $21,338,880,
Option 1, $11,330,470, Option 2:

$11,539,230 and Option 3: $7,271,594 ). For further provisions regarding the
specific cost-sharing arrangement, see the ADVANCE UNDERSTANDINGS Article in
SECTION B of the Contract.

B.5.LIMITATIONS APPLICABLE TO DIRECT COSTS

a.Items Unallowable Unless Otherwise Provided

Notwithstanding the clauses and unless authorized in writing by the Contracting
Officer or set forth in the Statement of Work, the cost of the following items
or activities shall be unallowable as direct costs:

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

2)Special rearrangement or alteration of facilities;

3)Accountable Government Property (see the HHS Contracting Guide for Control for
Government Property incorporated by Section G.9. of this contract);

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

4)Purchase or lease of scientific instruments or equipment over $10,000 except
for instruments and equipment specifically included in the Statement of Work;

5)Travel to attend general scientific meetings/conferences;

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

7)Overtime (premium) compensation

8)Entering into certain types of subcontracting arrangements (See Section B.5(c)
for specific obligations). Note that most consulting agreements require CO’s
written consent.

9)Foreign Travel (see Subparagraph b.3);

10)Patient care costs (see Section J-List of Attachments);

11)Light Refreshment and Meal Expenditures - Requests to use contract funds to
provide

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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 Meetings, 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 provide; (b) a brief description of the purpose of the event; (c)
a cost breakdown of the estimated light refreshments and/or meals costs;

(d) the number of nonfederal and federal attendees receiving light refreshments
and/or meals; and (e) if the event will be held at a government facility.

b.Travel Costs

1)Total expenditures for travel (transportation, lodging, subsistence, and
incidental expenses) incurred in direct performance of this contract during the
Base Period (CLIN 0001) shall not exceed $42,310 (BARDA share) without the prior
written approval of the Contracting Officer. The Contractor shall notify the
Contracting Officer in writing when travel expenditures have exceeded 80% of the
base period travel expenses. Costs must be consistent with Federal Acquisition
Regulations (FAR) 52.247-63 – Preference for U.S. Air Flag carriers.

2)Subject to the dollar limitation specified under B.5.b.1. above, the Contactor
shall invoice and be reimbursed for all travel costs in accordance with Federal
Acquisition Regulation (FAR) 31.2 – Contracts with Commercial Organizations,
Sub-Section 31.205- 46, Travel Costs.

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

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

•Meeting(s) and place(s) to be visited, with costs and dates; name(s) and
title(s) of Contractor personnel to travel and their functions in the contract
project;

•Contract purposes to be served by the travel;

•How travel of Contractor personnel will benefit and contribute to accomplishing
the contract project, or will otherwise justify the expenditure of BARDA
contract funds;

•How such advantages justify the costs for travel and absence from the project
of more than one person if such are suggested; and

•What additional functions may be performed by the travelers to accomplish other
purposes of the contract and thus further benefit the project.

B.6.ADVANCE UNDERSTANDINGS

a.Person-in-Plant

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

The Government’s representative shall be provided reasonable access, during
normal

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business hours, of the production areas being utilized in performance on the
Contract. As determined by federal law, no Government representative shall
publish, divulge, disclose, or make known in any manner, or to any extent not
authorized by law, any information coming to him in the course of employment or
official duties, while stationed in a contractor or subcontractor plant.

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

b.Security

No security plan is required at this point for this effort. It is anticipated
that a security waiver will be approved.

c.Subcontracts

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

●Is of the cost-reimbursement type and exceeds $150,000; or

●Is of the fixed price type and exceeds $150,000 or 5% of the contract,
whichever is less.

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 by the
Contracting Officer, the Contractor shall provide a copy of the signed, executed
subcontract and consulting agreement to the Contracting Officer within ten (10)
calendar days.

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

d.Overtime Compensation

No overtime (premium) compensation is authorized under the subject contract.

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

In an effort to build a robust medical countermeasure pipeline through increased
collaboration, the Government may share technical deliverables with Government
entities responsible for Medical Countermeasure Development. In accordance with
recommendations from the Public Health Emergency Medical Countermeasure
Enterprise Review, agreements established in the Integrated Portfolio Advisory
Committee (PAC) Charter, and agreements between BARDA and the Department of
Defense, the National Institutes of Health, the Centers for Disease Control, and
the Food and Drug Administration, BARDA may share technical deliverables and
test results created in the performance of this Contract with colleagues within
the Integrated Portfolio.

This advance understanding does not authorize the Government to share financial
information outside of the United States Government. 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.

f.Approval of Human and Animal Protocols

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The Contractor shall submit all human and animal protocols and human informed
consent documents as referenced under this Contract to the COR for review and
approval prior to seeking other approvals (Institutional Review Board, Human Use
Committee, Institutional Animal Care and Use Committee) unless the contractor
already had such approvals prior to contract award. The Government requires no
fewer than eight (8) business days to perform a review. The Contractor shall
take this review time into account and submit protocols as early as possible to
avoid delays. The Government’s comments and feedback shall be addressed prior to
approval. The COR will review and provide approval of protocols. Human informed
consents shall also be submitted and reviewed with any human protocol.

g.Rights in Data

The contract will incorporate the FAR Clause 52.227-14, Rights in Data—General.
The Contractor is advised to review the terms of FAR 52.227-14, Rights in Data,
regarding the government’s rights to deliverables submitted during performance
as well as the government’s rights to data contained within those deliverables.

h.Invoice Submission during end of Fiscal Year

The government will not accept invoices for processing from Sep 6th through Oct
5th because of end of year fiscal requirements. Any invoices received from
September 6th through October 5th will be canceled and returned to the
Contractor for resubmission beginning on October 6th.

i.Cost Sharing

1.This is a cost-sharing contract. Monies shall be provided for the total cost
of performance from the BARDA and Marinus Pharmaceuticals.

2.The Government shall provide monies in an amount not to exceed $51,480,174.
The Contractor's share is estimated at $32,567,975.

3.The Contractor shall maintain records of all contract costs (including costs
claimed by the Contractor as being its share) and such records shall be subject
to the Audit and Records-Negotiation and Final Decisions on Audit Findings
clauses of the General Clauses.

4.Costs contributed by the Contractor shall not be charged to the Government
under any other contract, grant, or cooperative agreement (including allocation
to other grants, contracts, or cooperative agreements as part of an independent
research and development program). The Contractor shall report the
organization's share of the costs expended by category, on the Financial Report
of Individual Project/Contract as referenced in the CONTRACT FINANCIAL REPORT
Article in SECTION G of this contract.

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

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 attached to this contract as Attachment 1 (Section J - List of
Attachments).

C.2.REPORTING REQUIREMENTS

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

C.3.PROJECT MEETING CONFERENCE CALLS

A conference call between the Contract Officer, the Contracting Officer’s
Representative (COR) and

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designees and the Contractor’s Project Leader/delegate and designees shall occur
bi-weekly or as otherwise mutually agreed upon by the Government and the
Contractor or determined by the Contracting Officer. During this call the
Contractor’s Project Leader/delegate and designees will discuss the activities
since the last call, any problems that have arisen and the activities planned
until the next call takes place. The Contractor’s Project Leader/delegate may
choose to include other key personnel on the conference call to give detailed
updates on specific projects or this may be requested by the Contracting
Officer’s Representative. Electronic copy of conference call meeting
minutes/summaries shall be provided via e-mail to the CO, COR, and uploaded in
eRoom by the Contractor within five (5) business days after the conference call
is held.

C.4.PROJECT MEETINGS

The Contractor shall participate in Project Meetings to coordinate the
performance of the contract, as requested by the COR. These meetings may include
face-to-face meetings with BARDA in Washington,

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

a.Kickoff Meeting

The Contractor and Government shall conduct a kickoff meeting within 45 calendar
days after contract award to review HHS procedures, processes and expectations.
Contractor shall provide an itinerary/agenda no later than 5 business days
before meeting. Minutes from the kickoff meeting must be provided within 10
business days of the event.

b.Semi-annual and Ad-Hoc Meetings

At the discretion of the CO or COR, 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 be conducted via
teleconferences or face-to-face meetings in Washington, D.C. or at work sites of
the Contractor and its subcontractors. Such meetings may include, but are not
limited to, meetings of the Contractor (and subcontractors invited by the
Contractor) to discuss study designs, site visits to the Contractor’s and
subcontractor’s facilities, and meetings with the Contractor and HHS officials
to discuss the technical, regulatory, and ethical aspects of the program. The
Contractor must provide data, reports, and presentations to groups of outside
experts (subject to appropriate protections for Contractor’s confidential or
proprietary data) and Government personnel as required by the Contracting
Officer’s Representative, giving reasonable prior notice of such requirement to
Contractor, in order to facilitate review of contract activities.

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

c.Face-to-Face Project Review Meetings

The Contractor shall, at a time to be determined later, present a comprehensive
review of contract progress to date in a face-to-face meeting in Washington, DC.
The Contractor will be responsible for updating the BARDA program on technical
progress under the Statement of Work. Presentation must be delivered seven (7)
business days prior to the scheduled meeting.

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C.5RISK MANAGEMENT

The Contractor shall establish and maintain an active, enterprise-wide risk
management system as well as a specific risk management plan that includes the
SOPs governing risk management, a description of the risk management activities
required to oversee the project across its range of scope, and the processes for
reviewing completed risk mitigations. The Contractor shall complete risk
management documentation for the program as applicable.

C.6REGULATORY ACTIVITIES

The Contractor shall provide the COR the opportunity to review and comment upon
any draft documents, including draft pre-submission packages, and meeting
requests, to be submitted to the FDA or other regulatory agency. The Contractor
shall provide the COR with five (5) business days for review and comments. An
acceptable version shall be provided to the COR prior to FDA submission.

The Contractor shall provide the COR initial draft minutes and final draft
minutes of any - meeting with the FDA and other regulatory agencies.

The Contractor shall communicate the dates and times of any meeting with the FDA
and other regulatory agencies to the COR and ensure participation for
appropriate COR and BARDA SME staff to attend the meetings.

The Contractor shall forward Standard Operating Procedures (SOPs) upon request
from Contracting Officer’s Representative /Contracting Officer.

The Contractor shall work to support BARDA in development of FDA submissions and
meeting for seeking a Pre-Emergency Use Authorization if deemed necessary by
BARDA. The support may require the Contractor to develop unique deliverables
other than the ones related to the SOW for submission to the FDA by BARDA.

The Contractor shall support FDA audits. Within thirty (30) calendar days of an
FDA audit of Contractor or subcontractor facilities, the Contractor shall
provide copies of the audit findings, final report, and a plan for addressing
areas of nonconformance to FDA regulations and guidance for GLP, GMP or GCP
guidelines as identified in the final audit report.

C.7QUALITY

The Contractor shall establish and maintain a Quality Management System with
sufficient content to include but not limited to the elements contained in the
Code of Federal Regulations Title 21 Part 820.

The Contractor shall establish routine internal reviews, documentation, and
evidence of the ability to maintain, and adhere to the Code of Federal
Regulations Title 21 Part 820.

The Contractor shall contract for an independent audit of its system quality
system adherence, resolve any issues noted by the auditor, and provide the audit
findings and resolutions to the Government.

SECTION D – PACKAGING, MARKING, AND SHIPPING

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

Unless otherwise specified by the CO, delivery of reports to be furnished to the
Government under this

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

contract (including invoices) shall be delivered to the CO and COR
electronically along with a concurrent email notification to the CO and COR (as
defined in Section F.3. Electronic Submission) summarizing the electronic
delivery:

SECTION E – INSPECTION AND ACCEPTANCE

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

This contract incorporates the following clauses by reference, with the same
force and effect as if they were given in full text. Upon request, the
Contracting Officer will make their full text available. Also, the full text of
a clause may be accessed electronically at: https://www.acquisition.gov/FAR/
HHSAR Clauses at: http://www.hhs.gov/policies/hhsar/subpart352.html.

FAR ClauseTitle and Date

FAR 52.246-3, Inspection of Supplies – Cost-Reimbursement (May 2001)

FAR 52.246-9, Inspection of Research and Development (Short Form) (April 1984)
FAR 52.246-16, Responsibility for Supplies (April 1984)

E.2.DESIGNATION OF GOVERNMENT PERSONNEL

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

E.3.INSPECTION, ACCEPTANCE AND CONTRACT MONITORING

Inspection and acceptance of the product, services, and documentation called for
herein shall be accomplished by the Contracting Officer or a duly authorized
representative. Delivery, technical inspection and acceptance will take place at
a location designated by the Contracting Officer or at:

Office of the Assistant Secretary for Preparedness and Response Biomedical
Advanced Research and Development Authority O’Neill House Office Building

Washington, DC 20515

a.Site Visits and Inspections

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

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

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acceptance:

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

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

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

SECTION F – DELIVERIES OR PERFORMANCE

F.1.ESTIMATED PERIOD OF PERFORMANCE

The estimated period of performance for this contract shall be consistent with
the dates set forth in the Base Period in Section B.2. If the Government
exercises the Options Period(s) pursuant to the Option Clause in Section I.3 of
the contract, the period of performance shall be increased as shown in the table
in Section B.3.

F.2.DELIVERABLES

Successful performance of the final contract shall be deemed to occur upon
completion of performance of the work set forth in the Statement of Work dated
August 5, 2020, 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
COR, of each of the deliverables described in Section C, Section F, and Section
J.

All deliverables and reporting documents listed within this Section shall be
delivered electronically (as defined in Section F.3 Electronic Submission) to
the CO, CS, and the COR unless otherwise specified by the CO.

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

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

HHS/ASPR/BARDA/CMA:

ATTN: James Bowers (Contracting Officer)

U.S. Department of Health & Human Services

Office of the Assistant Secretary for Preparedness and Response Biomedical
Research and Development Authority (BARDA) Contract Management and Acquisition
(CMA)

O’Neill House Office Building Room Number: 22G11 Washington, DC 20515

Email: carl.newman@hhs.gov

HHS/ASPR/BARDA:

ATTN: Michael Schwartz (COR)

U.S.Department of Health & Human Services

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

Office of the Assistant Secretary for Preparedness and Response Biomedical
Advanced Research & Development Authority (BARDA) O’Neill House Office Building

Room Number: 24K14 Washington, DC 20515

Email: michael.schwartz@hhs.gov

Contract Data Requirements List (CDRLs)

CDRL#

Deliverable

Description

Reporting Procedures and Due Dates

01

Kickoff Meeting

The Contractor shall complete a Kickoff meeting after contract award

●
Within 45 calendar days after contract award.

●
Materials: Contractor shall provide itinerary and agenda to CO and COR at least
5 business days in advance of meeting. CO approves and the COR distributes
itinerary and agenda within 3 business days.

●
Due out: Contractor provides meeting minutes to CO and COR within 5 business
days after the meeting. The CO and COR reviews, comments, and the CO approves
minutes within 10 business days of the event.

02

Semi-annual Meetings

At the discretion of the government the Contractor shall hold recurring
teleconference or face-to- face Project Review Meetings up to two per year
either in Washington D.C or at work sites of the Contractor or subcontractors.
Face-to-face meetings shall alternate between Washington DC and Contractor,
sub-contractor sites. The meetings will be used to discuss contract progress in
relation to the Program Management deliverables described below as well as study
designs, technical, regulatory, and

●
Materials: Contractor shall provide itinerary and agenda to CO and COR at least
5 business days in advance of meeting. The COR approves and distributes
itinerary and agenda within 3 business days.

●
Due out: Contractor provides meeting minutes to the CO and the COR within 5
business days after the meeting. The CO and COR reviews, comments, and the CO
approves minutes

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

CDRL#

Deliverable

Description

Reporting Procedures and Due Dates

ethical aspects of the program.

within 10 business days.

03

Biweekly Teleconference Meetings

The Contractor shall participate in teleconferences every two weeks with the CO
and the COR to discuss the performance of the contract.

●
Materials: Contractor provides agenda to the CO and COR no later than 2 business
days in advance of meeting. The COR approves and distributes agenda prior to
meeting.

●
Due out: Contractor provides meeting minutes to the CO and COR within 5 business
days following the meeting. The CO and COR reviews, comments, and the COR
approves minutes within 10 business days following the meeting.

04

(Monthly) 05

(Annual)

Monthly & Annual Technical Progress Reports

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

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

2.
Progress in meeting contract milestones – broken out by subtasks

●
Due: Monthly Reports shall be submitted on the 15th day of the month after the
end of each month with an Annual Report submitted on the 30th calendar day of
the final month of each contract year for the previous twelve calendar months.

●
When the 15th or 30th falls on a weekend or a US Holiday, the reports will be
due the next business day.

●
Monthly progress reports are not required for the periods when the Annual
Report(s) and Final Report are due.

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CDRL#

Deliverable

Description

Reporting Procedures and Due Dates

within each milestone, overall project assessment, problems encountered and
recommended solutions. The reports shall detail the planned and actual progress
during the period covered, explaining occurrences of any differences between the
two and the corrective steps.

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

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

5.
Estimated and Actual Expenses.

6.
This report shall also contain a narrative or table detailing whether there is a
significant discrepancy (>10%) at this time between the % of work completed and
the cumulative costs incurred to date. Monthly and actual expenses should be
broken down to the appropriate WBS level. This section of the report should also
contain estimates for the Subcontractors’ expenses from the previous month if
the Subcontractor did not submit a bill in the previous month. If the
subcontractor(s) was not working or did not incur any costs in the previous
month, then a statement to this effect should be included in this report for

The CO and the COR will review the monthly reports and provide feedback within 5
business days of receiving the report. The CO approves acceptance of monthly and
annual reports.

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

CDRL#

Deliverable

Description

Reporting Procedures and Due Dates

those respective subcontractors.

06

Risk Management Plan

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

●
Due: Within 90 days of contract award.

●
Due out: Contractor provides updated Risk Management Plan in Monthly Progress
Report. The COR shall provide Contractor with written comments in response
submitted plan. Contractor must address, in writing, all commercially reasonable
concerns raised by the COR within 20 business days of Contractor’s receipt of
COR’s concerns for CO approval.

07

Deviation Notification and Mitigation Strategy

Process for changing IMS activities associated with cost and schedule.
Contractor shall notify BARDA of significant changes the IMS defined as
increases in cost above 5% or schedule slippage of more than 30 days, which
would require a PoP extension.

Contractor shall provide a high-level management strategy for risk mitigation.

●
Due: As needed and communicated by the COR/CO.

08

Go/No-Go In- Process Review (IPR) or Decision Gate Presentation

Contractor shall provide a presentation detailing technical progress made
towards completion of Go/No-Go decision gate milestones following a prescribed
template provided by BARDA prior to the IPR.

●
Materials: Contractor shall provide presentation materials to the CO and COR 10
business days prior to the In- Process Review (IPR). Contractor shall submit
written justification of progress towards satisfying Go/No-Go criteria. After
reviewing, the CO and COR will provide a written response

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CDRL#

Deliverable

Description

Reporting Procedures and Due Dates

within 10 business days.

09

Incident Report

Contractor shall communicate and document all critical programmatic concerns,
risks, or potential risks with the CO and COR.

●
Due: Within 48 hours of activity or incident or within 24 hours for a security
activity or incident via email or telephone, with written follow-up to the CO
and COR. Additional updates due within 48 hours of additional developments.

●
Due out: Contractor shall submit, within 5 business days, a Corrective Action
Plan (if deemed necessary by either party) to address any potential issues. If
corrective action is deemed necessary, Contractor must address in writing, its
consideration of concerns raised by the CO, within 5 business days of receiving
such concerns in writing.

10

Draft and Final Reports for Clinical and Non- Clinical Studies

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

●
Draft - within 45 calendar days after completion of analysis and at least 15
business days prior to submission to FDA. Subcontractor prepared reports
received by the Contractor shall be submitted to the CO and COR for review and
comment no later than 5 business days after receipt by Contractor. The CO shall
provide written comments to the Draft Final Report for Clinical and Non-

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

CDRL#

Deliverable

Description

Reporting Procedures and Due Dates

Clinical Studies within 15 business days after the submission.

●
Final - due 30 calendar days after receiving comments on the Draft Final Report
for Clinical and Non-Clinical Studies. If corrective action is recommended,
Contractor must address, in writing, all reasonable concerns raised by the CO in
writing. Contractor shall consider revising reports to address CO’s
recommendations prior to FDA submission.

●
Final FDA submissions shall be provided to the CO and COR concurrently or no
later than 5 business days after submission to the FDA.

11

Standard Operating Procedures

The Contractor shall make internal and, to the extent possible, subcontractor
Standard Operating Procedures (SOPs) available for review electronically.

Upon request from the CO.

12

FDA

Correspondence

The Contractor shall memorialize any correspondence between Contractor and FDA
and submit to the CO and COR. All documents shall be duly marked as either
“Draft” or “Final”.

●
Due: Contractor shall provide written summary of any FDA correspondence within 5
business days of correspondence.

13

FDA Meetings

The Contractor shall forward the dates and times of any meeting with the FDA to
the CO and COR and make arrangements for appropriate government staff to attend
the FDA meetings.

Government staff shall

●
Contractor shall schedule upcoming FDA meetings, so at a minimum the CO, COR,
and RQA persons from BARDA can attend. Additionally, a pre-

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

CDRL#

Deliverable

Description

Reporting Procedures and Due Dates

include up to a maximum of four people (COR, CO and up to 2 subject matter
experts).

meeting needs to be held with BARDA to review slides and discuss meeting
strategies.

●
Contractor shall notify the CO and COR of upcoming FDA meeting within 24 hours
of scheduling.

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

14

FDA Submissions

The Contractor shall provide the CO and COR the opportunity to review and
comment upon all draft submissions before submission to the FDA. Contractor
shall provide the CO and COR with an electronic copy of the final FDA
submission. All documents shall be duly marked as either “Draft” or “Final”.

●
Due: Contractor shall submit draft FDA submissions to the CO and COR at least 15
business days prior to FDA submission. The CO and COR will provide feedback to
Contractor within 10 business days of receipt.

●
Due out: If corrective action is recommended, the Contractor must address, in
writing, its consideration of all concerns raised by the CO.

●
The Contractor shall consider revising their documents to address CO’s concerns
and/or recommendations prior to FDA submission.

●
Final FDA submissions shall be submitted to the CO and COR concurrently

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

CDRL#

Deliverable

Description

Reporting Procedures and Due Dates

or no later than 5 calendar day of its submission to CDER.

15

FDA Audits

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

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

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

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

16

QA Audit Reports

BARDA Quality group and /or their qualified representatives 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

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

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

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CDRL#

Deliverable

Description

Reporting Procedures and Due Dates

GCP guidelines, as identified in the audit report, must be provided to the CO
and COR. The Contractor shall provide responses from the subcontractors to
address these concerns and plans for corrective action execution.

17

BARDA Audit

Contractor shall accommodate periodic or ad hoc site visits by the CO and COR.

Contractor shall also accommodate any ‘for cause’ audit if and when there are
potential issues identified in the program during the period of performance.
Such issues include but are not limited to stability failures, GLP issues etc.

If the CO, COR, 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 CO and COR.

●
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.

●
Due out: The CO and COR will review the report and provide a response to the
Contractor with 10 business days. Once corrective action is completed, the
Contractor will provide a final report to the CO and COR.

18

Technical Documents

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

●
Contractor shall provide technical document within 10 business days of COR’s
request. Contractor can request additional time on an as needed basis.

●
If corrective action is recommended by the COR, the Contractor must address, in
writing, concerns raised by the COR to the COR and CO in writing.

19

Raw Data or Data Analysis

Contractor shall provide raw data and/or data analysis to the CO and COR upon
request.

Contractor shall address and adjudicate all concerns from

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

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CDRL#

Deliverable

Description

Reporting Procedures and Due Dates

BARDA review of the data/analysis and amend the reports as required.

●
Contractor shall amend the reports if required and adjudicate all comments.

20

Publications

Any manuscript or scientific meeting abstract containing data generated under
this contract must be submitted to the CO and COR for review prior to
submission.

●
Contractor must submit all manuscript or scientific meeting abstract to the CO
and COR within 30 days for manuscripts and 15 days for abstracts.

●
Contractor must address in writing all concerns raised by the CO and COR in
writing.

●
Final submissions shall be submitted to the CO and COR concurrently or no later
than five (5) calendar days after its submission.

21

Press Releases

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

●
With the exception of ad-hoc press releases required by applicable law or
regulations, Contractor shall ensure that the CO and COR has received and
approved an advanced copy of any draft press release to this contract not less
than 2 business days prior to the issuance of the press release. The CO shall
reply with comments within 1 business day of receipt of the draft press release.
Should no comments be forthcoming from the CO by end of the 1st business day,
Contractor will be permitted to issue the press release

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CDRL#

Deliverable

Description

Reporting Procedures and Due Dates

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

●
Any final press releases shall be submitted to the CO and COR no later than 1
(one) calendar day prior to its release.

22

Integrated Master Schedule (IMS)-Gantt

The Contractor shall provide an IMS including WBS, critical path, and
milestones.

●
Due: Contractor shall provide the draft IMS- Gantt within 90 days of contract
award with final due 8 months after award and updated monthly as part of the
Monthly Progress Report.

●
Contractor must address, in writing, all concerns raised by the COR in writing
and provide response to the CO and COR.

23

Draft and Final Technical Progress Report

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

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

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

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

●
Due out: the CO shall provide feedback on

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CDRL#

Deliverable

Description

Reporting Procedures and Due Dates

milestones. The final report shall be duly marked as ’Final’.

draft report within 15 calendar days of receipt, which the Contractor shall
consider incorporating into the Final Report.

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

24

Draft and Final Study Protocols

Contractor shall provide all Draft and Final Study Protocols to the

COR for evaluation. (The CO and COR reserves the right to request within the
period of performance a non- proprietary Study Protocol for distribution within
the US Government.

●
The Contractor will submit all proposed protocols to the CO and COR at least 10
business days prior to study start. If corrective action is required, the
Contractor must address in writing all concerns raised by the CO and COR to

the satisfaction of the COR before study execution and provide the CO and COR a
revised draft protocol that addresses the CO’s comments and requested changes.

●
After receiving the revised Study Protocol that satisfies the COR, the CO will
approve the revised Study Protocol and will provide a written approval to the
Contractor that provides authorization to the Contractor to execute the specific
study.

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CDRL#

Deliverable

Description

Reporting Procedures and Due Dates

●
Contractor shall not proceed with any study protocol until the COR gives its
approval and the Contractor has provided the CO and COR with a final and
approved Study Protocol.

25

Clinical Study Status Update

Contractor shall provide COR with a status update of clinical studies that are
actively enrolling patients to include by study site: cumulative enrollment; new
enrollments; screen failures; patients dropped from study; AE and SAEs;
activation or inactivation of study sites; investigator appointments or changes;
and status of IRB/IEC review/approval/renewal.

Contractor will provide proposed format for the COR’s review and approval.

●
Update will be submitted by e-mail or other electronic format to be provided by
the COR by the end of the 25th business day of each new month.

●
When the 25th falls on a weekend or US Holiday, the update will be due the next
business day.

●
Updates, to the extent they are available, will be presented during biweekly
teleconferences.

●
If no changes have occurred since the prior update only a simple statement that
there is no new data is required.

NOTE: Pursuant to federal law, no Government personnel shall publish, divulge,
disclose, or otherwise make known to any non-Government entity any Contractor
data marked according to FAR 52.227-14, unless permitted to do so by law or
regulation.

Detailed Description of Select Contract Deliverables

A.Monthly and Annual Progress Reports

In addition to those reports required by the other terms of this contract, the
Contractor shall prepare and submit the following reports in the manner stated
below and in accordance with this

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Section F of this contract, and in the Statement of Work, attached to this
contract (see Section J- List of Attachments).

i.Monthly Progress Report

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

The Contractor shall submit a Monthly Progress Report according to the dates set
forth in the summary table (“Summary of Contract Deliverables”) under this
Section. The progress report shall conform to the requirements set forth in the
Deliverables Chart in Section F of this contract.

The format should include:

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

●SECTION I – EXECUTIVE SUMMARY

●SECTION II - PROGRESS

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

●SECTION II Part B: MANAGEMENT AND ADMINISTRATIVE UPDATE - A description of all
meetings, conference calls, etc. that have taken place during the reporting
period. Include progress on administration and management issues (e.g.,
evaluating, and managing subcontractor performance, and personnel changes).

●SECTION II Part C: TECHNICAL PROGRESS - For each activity related to Gantt
chart, document the results of work completed and cost incurred during the
period covered in relation to proposed progress, effort and budget. The report
shall be in sufficient detail to explain comprehensively the results achieved.
The description shall include pertinent data and/or graphs in sufficient detail
to explain any significant results achieved and preliminary conclusions
resulting from analysis and scientific evaluation of data accumulated to date
under the contract. The report shall include a description of problems
encountered and proposed corrective action; differences between planned and
actual progress, why the differences have occurred and what corrective actions
are planned; preliminary conclusions resulting from analysis and scientific
evaluation of data accumulated to date under the project.

●SECTION II Part D: PROPOSED WORK - A summary of work proposed related to Gantt
chart for the next reporting period and preprints/reprints of papers and
abstracts.

●SECTION III: Estimated and Actual Expenses.

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

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to this effect should be included in this report for those respective
subcontractors.

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

ii.Annual Progress Report

This report shall include a summation of the results of the entire contract work
for the period covered. Monthly Progress Reports shall not be submitted in the
same month when an Annual Progress Report is due. Furthermore, an Annual
Progress Report will not be required for the period when the Final Report is
due. The first Annual Progress Report shall be submitted in accordance with the
date set forth in the table (“Summary of Contract Deliverables”) under Section
F.2. of this contract. The progress report shall conform to the requirements set
forth in the Deliverables Chart in Section F of this contract.

Each Annual Progress Report shall include:

●A Cover page that includes the contract number and title; the type of report
and period that it covers; the Contractor's name, address, telephone number, fax
number, and email address; and the date of submission;

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

●SECTION II: PROGRESS

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

●SECTION II Part B: MANAGEMENT AND ADMINISTRATIVE UPDATE -

A high level summary of critical meetings, etc. that have taken place during the
reporting period. Include progress on administration and management to critical
factors of the project (e.g. regulatory compliance

audits and key personnel changes).

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

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

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

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

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

iii.Draft Final Report and Final Report

These reports are to include a summation of the work performed and results
obtained for the entire contract period of performance. This report shall be in
sufficient detail to describe comprehensively the results achieved. The Draft
Final

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Report and Final Report shall be submitted in accordance with the Deliverables
Chart in Section F of the contract. An Annual Progress Report will not be
required for the period when the Final Report is due. The Draft Final Report and
the Final Report shall be submitted in accordance with the dates set forth in
the table (“Summary of Contract Deliverables”) under SECTION F.2. of this
contract. The report shall conform to the following format:

1.Cover page to include the contract number, contract title, performance period
covered, Contractor's name and address, telephone number, fax number, email
address and submission date.

2.SECTION I: EXECUTIVE SUMMARY - Summarize the purpose and scope of the contract
effort including a summary of the major accomplishments relative to the specific
activities set forth in the Statement of Work.

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

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

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

iv.Summary of Salient Results

The Contractor shall submit, with the Final Report, a summary of salient results
achieved during the performance of the contract.

v.Audit Reports

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

vi.Periodic Document Review

Upon request, Contractor shall provide CO and COR with the following contract
funded documents as specified below but not limited to: Process Development
Reports; Assay Qualification Plan/Report, Assay Validation Plan/Report, Assay
Technology Transfer Report, Batch Records, Contractor/Subcontractor Standard
Operating Procedures (SOP’s), Master Production Records, Certificate of
Analysis, Clinical Studies Data or Reports. The CO and COR reserve the right to
request within

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the Period of Performance a non-proprietary technical document for distribution
within the Government. Contractor shall provide technical document within 10
business days of CO or COR request. Contractor can request additional time on an
as needed basis. If edits are recommended, the Contractor must address, in
writing, concerns raised by BARDA in writing.

vii.Risk Management Plan

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

●Due within 180 days of contract award

●Contractor provides updated Risk Management Plan in Monthly Progress Report

●The COR shall provide Contractor with a written list of concerns in response
plan submitted

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

B.Deliverables Arising from FDA Correspondence

i.FDA Meetings

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

●Contractor shall notify BARDA of upcoming FDA meeting within 24 hours of
scheduling.

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

ii.FDA Submissions

The Contractor shall provide the COR all documents submitted to the FDA.

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

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

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

●Final FDA submissions shall be submitted to the CO and COR concurrently or no
later than 5 calendar days of their submission to FDA.

iii.FDA Audits

In the event of an FDA inspection which occurs as a result of this contract and
for the product, or for any other FDA inspection that has the reasonable
potential to impact the

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performance of this contract, the Contractor shall provide the CO and COR with
an exact copy

(non-redacted) of the FDA Form 483 and the Establishment Inspection Report (EIR)
within five (5) business days after the Contractors receipt of those documents.
The Contractor shall provide the COR and CO with copies of the plan for
addressing areas of non-conformance to FDA regulations for GLP, GMP, or GCP
guidelines as identified in the audit report, status updates during the plans
execution and a copy of all final responses to the FDA. The Contractor shall
also provide redacted copies of any FDA audits received from subcontractors that
occur as a result of this contract or for this product. The Contractor shall
make arrangements for BARDA representative(s) to be present during the final
debrief by the regulatory inspector.

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

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

●Within 15 business days of audit report, Contractor shall provide CO with a
plan for addressing areas of nonconformance, if any are identified.

iv.Other FDA Correspondence

The Contractor shall memorialize any correspondence between Contractor and FDA
as related to activities funded under this contract and submit to BARDA. All
documents shall be duly marked as either “Draft” or “Final.” Contractor shall
provide written summary of any FDA correspondence within 5 business days of
correspondence.

F.3.ELECTRONIC SUBMISSION

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

F.4.SUBJECT INVENTION REPORTING REQUIREMENT

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

27.303 (b)(2)(ii)) shall be submitted to the Contracting Officer on the
expiration date of the contract.

Reports and documentation submitted to the Contracting Officer shall be sent to
the address set forth in Section G – Contract Administration Data.

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

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F.5.FEDERAL ACQUISITION REGULATION CLAUSES INCORPORATED BY REFERENCE

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

FAR 52.242-15, Stop Work Order (August 1989), Alternate 1 (April 1984)

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SECTION G - CONTRACT ADMINISTRATION DATA

G.1.CONTRACTING OFFICER

The following Contracting Officers (CO) will represent the Government for the
purpose of this contract: DHHS/OS/ASPR/DCMA

James P. Bowers Contracting Officer

Room 21B05 –O’Neill House Office ‘Building Washington D.C. 20515

Phone 202 205 4857

Email: james.bowers@hhs.gov

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

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

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

4)The Government may unilaterally change its CO designation, after which it will
notify the Contractor in writing of such change.

G.2.CONTRACTING OFFICER'S REPRESENTATIVE (COR)

The following Contracting Officer's Representative (COR) will represent the
Government for the purpose of this contract: ATTN: Michael Schwartz (COR)

U.S.Department of Health & Human Services

Office of the Assistant Secretary for Preparedness and Response Biomedical
Advanced Research & Development Authority (BARDA) O’Neill House Office Building

Room Number: 24K14 Washington, DC 20515

Email: michael.schwartz@hhs.gov

The COR is responsible for:

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

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

3)Performing technical evaluation as required;

4)Performing technical inspections and acceptances required by this contract;
and

5)Assisting in the resolution of technical problems encountered during
performance. The Government may unilaterally change its COR designation, after
which it will notify Contractor in writing of such change.

G.3.KEY PERSONNEL

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

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Name

Title

Michael Saporito

Principal Investigator

Tony DiPaolo

Project Manager

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) and qualifications of the
individual proposed as a substitute 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. At a minimum, the key
personnel should include the project manager, principal investigator, radiation
biologist, quality control manager, quality assurance director, regulatory lead,
and manufacturing lead.

G.4.CONTRACT FINANCIAL REPORT

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

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

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

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

e.The listing of expenditure categories to be reported is incorporated as a part
of this contract and can be found under Section J entitled, "Financial Report of
Individual Project/Contract,".

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

g.Contractor invoices/financial reports shall conform to the form, format, and
content requirements of the instructions for Invoice/Financing requests and
Contract Financial Reporting, and be sent to the following points of contact:

O

COR

PSC

James Bowers(Contracting Officer) HHS/ASPR/BARDA/CMA

O’Neill House Office Building

Room Number: 22G11 Washington, DC 20515 james.bowers@hhs.gov

Michael Schwartz COR HHS/ASPR/BARDA

O’Neill House Office Building

Room Number: 24K14 Washington, DC 20515

202- 260 0849 (Office)

michael.schwartz@hhs.gov

PSC_Invoices@psc.hhs.gov &

“e-Room”

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

Limitation of Cost (Apr 1984)

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

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

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

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

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

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

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

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

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

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

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

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

h.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.

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

j.All invoice submissions shall be in accordance with FAR Clause 52.232-25,
Prompt Payment (Oct 2008).

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

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

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

2.Fringe Benefits - Cite rate and amount

3.Overhead - Cite rate and amount

4.Materials & Supplies - Include detailed breakdown when total amount is over

$10,000.

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

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

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

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

9.Other Direct Costs - Include detailed breakdown when total amount is over

$10,000.

10.G&A - Cite rate and amount.

11.Total Cost (and applicable cost-shared ratio)

12.Fixed Fee (if applicable)

13.Total Cost Plus Fixed Fee

Additional instructions and an invoice template are provided in Section J-List
of Attachments, Invoice/Financing Request Instructions and Contract Financial
Reporting Instructions for Cost- Reimbursement Contracts. All invoices must be
signed by a representative of the contractor authorized to certify listed
charges are accurate and comply with government regulations. Invoices shall be
signed and submitted electronically (in accordance with Section F.3 Electronic
Submission).

If applicable, the Contractor shall convert any foreign currency amount(s) in
the monthly invoice to U.S. dollars each month, on the 1st of the month, using
the foreign exchange rate index published on www.federalreserve.gov. Payment of
invoices is subject to the U.S. dollar limits within the Total Costs of CLIN
0001 in Section B of the contract.

The Government shall use electronic funds transfer to the maximum extent
possible when making payments under this contract. FAR 52.232-33, Payment by
Electronic Funds Transfer–System for Award Management, in Section I requires the
Contractor to designate in writing a financial institution for receipt of
electronic funds transfer payments.

G.5.REIMBURSEMENT OF COST

The Government shall reimburse the Contractor the cost determined by the
Contracting Officer to be allowable (hereinafter referred

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to as allowable cost) in accordance with FAR Clause 52.216-7, Allowable Cost and
Payment incorporated by reference in Section I, Contract Clauses, of this
contract, 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 performing the work
provided for under the contract, including those purchased for subcontracts and
purchase orders.

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

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

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

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

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

(iii)Costs incurred for lodging, meals, and incidental expenses shall be
considered reasonable and allowable to the extent that they 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.

G.6.INDIRECT COST RATES

The following Contractor established provisional billing rates are incorporated
into the contract, and will be utilized for billing purposes during the Base
Period (CLIN 0001) and total estimated cost reimbursement Option Periods (CLINs
0002 and 0003) ONLY if exercised by the CO pending the establishment of final
indirect cost rates for each fiscal year or until revised by the CO in
accordance with the provisions of FAR 42.705-1. FAR clause 52.216-7 will be
utilized for billing purposes during both the Base Period (CLIN 0001) and total
estimated cost reimbursement Option Periods (CLINs 0002, 0003 and 0004) ONLY if
exercised by the CO.

Rate Type

Ceiling

Allocation Base

Overhead

29%

Applied to total direct labor

G&A

20%

Applied to total direct costs & applicable O/H

The indirect cost ceilings are established for the Base Period (CLIN 0001) and
total estimated cost reimbursement Option Periods (CLINs 0002, 0003 and 0004)
ONLY if exercised by the CO. In addition the ceilings are capped. The Contractor
cannot seek reimbursement in excess of the Indirect Cost Ceilings. In the event
the final indirect cost rates are less than the established ceiling rates above,
the established rates will be reduced to conform to the lower rates.

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

Final rate proposals must be sent to the CO, within 6 months subsequent to the
fiscal year end. (See also FAR Clause 52.216-7 incorporated herein). In the
event the final indirect cost rates are less than the established ceiling rates
above, the established rates will be reduced to conform to the lower rates.

G.7.POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE Contractor Performance
Evaluations

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Interim and final evaluations of Contractor performance will be prepared on this
contract in accordance with FAR Subpart 42.15. The final performance evaluation
will be prepared at the time of completion of work. In addition to the final
evaluation, an interim evaluation shall be submitted annually.

Interim and final evaluations will be provided to the Contractor as soon as
practicable after completion of the evaluation. The Contractor will be permitted
thirty days to review the document and to submit additional information or a
rebutting statement. If agreement cannot be reached between the parties, the
matter will be referred to an individual one level above the Contracting Officer
whose decision will be final.

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.

Electronic Access to Contractor Performance Evaluations

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

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

The registration process requires the Contractor to identify an individual that
will serve as a primary contact and who will be authorized access to the
evaluation for review and comment. In addition, the Contractor will be required
to identify an alternate contact that will be responsible for notifying the
cognizant contracting official in the event the primary contact is unavailable
to process the evaluation within the required 30-day time frame.

G.8.CONTRACT COMMUNICATIONS/CORRESPONDENCE (JULY 1999)

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

G.9.GOVERNMENT PROPERTY

In addition to the requirements of the Government Property clause incorporated
in Section I of this contract, the Contractor shall comply with the provisions
of HHS Publication, "HHS Contracting Guide for Control of Government Property,"
which is incorporated into this contract by reference. This document can be
accessed at:

https://archive.org/details/contractorsguide00unit

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

Notwithstanding the provisions outlined in the HHS Publication, "HHS Contracting
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 attached to this contract (see Section J- List of
Attachments). Title will vest in the Government for equipment purchased as a
direct cost.

SECTION H - SPECIAL CONTRACT REQUIREMENTS

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

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H.1 CLINICAL AND NON-CLINICAL TERMS OF AWARD

BARDA has a responsibility to obtain documentation concerning mechanisms and
procedures that are in place to protect the safety of participants and animals
in BARDA funded clinical trials and non-clinical studies. Therefore, the
Contractor shall develop a protocol for each clinical trial and non-clinical
study funded under this contract and submit all such protocols and protocol
amendments to the Contracting Officer’s Representative (COR) for evaluation and
comment.

Approval by the COR is required before work under a protocol may begin. The COR
comments will be forwarded to the Contractor within ten (10) business days. The
Contractor must address, in

writing, all concerns (e.g. study design, safety, regulatory, ethical, and
conflict of interest) noted by the COR.

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

F.2of this contract.

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

The Government shall have unlimited rights to all protocols, data resulting from
execution of these protocols, and final reports funded by BARDA under this
contract, as set forth in the FAR clauses referenced in PART II of this
contract. The Government reserves the right to request that the Contractor
provide any contract deliverable in a non-proprietary form to ensure the
Government has the ability to review and distribute the deliverables as the
Government deems necessary. Important information regarding performing human
subject research is available at
https://www.niaid.nih.gov/research/clinical-research.

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

1.Non-Clinical Terms of Award

This contract does not involve the use of animals.

2.Clinical Terms of Award

These Clinical Terms of Award detail an agreement between the Government and the
Contractor; they apply to all grants and contracts that involve clinical
research.

BARDA shall have unlimited rights to all protocols, data generated from the
execution of these protocols, and final reports, funded by BARDA under this
contract, as defined in Rights in Data Clause in FAR 52.227-14. BARDA reserves
the right to request that the Contractor provide any contract deliverable in a
without any restrictive legends to ensure BARDA has the ability to review and
distribute the deliverables, as BARDA deems necessary.

a.Safety and Monitoring Issues

i.Institutional Review Board or Independent Ethics Committee Approval

Within 30 days of award and then with the annual progress report, the Contractor
must submit to the COR a copy of the current IRB-or IEC-approved informed
consent document, documentation of continuing review and approval and the OHRP
federal wide assurance number for the institution or site.

If other institutions are involved in the research (e.g., a multicenter clinical
trial or study), each institution’s IRB or IEC must review and approve the
protocol. They must also provide BARDA initial and annual documentation of

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continuing review and approval, including the current approved informed consent
document and federal wide number.

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

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

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

●All changes in informed consent documents, identified by version number, dates,
or both and dates it is valid.

●Termination or temporary suspension of patient accrual.

●Termination or temporary suspension of the protocol.

●Any change in IRB approval.

●Any other problems or issues that could affect the participants in the studies.

The Contractor must notify the COR and CO of any of the above changes within
five (5) working days by email or fax, followed by a letter signed by the
institutional business official, detailing notification of the change of status
to the local IRB and a copy of any responses from the IRB or IEC.

If a clinical protocol has been reviewed by an institutional biosafety committee
(IBC) or the NIH Recombinant DNA Advisory Committee (RAC), the Contractor must
provide information about the initial and ongoing review and approval, if

any. See the NIH Guidelines for Research Involving Recombinant DNA Molecules.

ii.Data and Safety Monitoring Requirements

BARDA strongly recommends independent safety monitoring for clinical trials of
investigational drugs, devices, or biologics; clinical trial of licensed
products; and clinical research of any type involving more than minimal risk to
volunteers. Independent monitoring can take a variety of forms. Phase III
clinical trials must be reviewed by an independent data and safety monitoring
board (DSMB); other trials may require DSMB oversight as well. The Contractor
shall inform BARDA of any upcoming site visits and/or audits of CRO facilities
funded under this effort. BARDA reserves the right to accompany the Contractor
on site visits and/or audits of CROs as BARDA deems necessary.

A risk is minimal where the probability and magnitude of harm or discomfort
anticipated in the proposed research and not greater than those ordinarily
encountered in daily life or during the performance of routine physical or
psychological examinations or tests. For examples, the risk of drawing a small
amount of blood from a healthy individual for research purposes is no greater
than the risk of doing so as part of a routine physical examination (45 CFR
46.102I).

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

◾Independent Safety Monitor – a physician or other appropriate expert who

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is independent of the study and available in real time to review and recommend
appropriate action regarding adverse events and other safety issues.

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

◾Data and Safety Monitoring Board – an independent committee charged with
reviewing safety and trial progress and providing advice with respect to study
continuation, modification, and termination. The Contractor may be required to
use an established BARDA DSMB or to organize an independent DSMB. All phase III
clinical trials must be reviewed by a DSMB; other trials may require DSMB
oversight as well. Please refer to: NIAID Principles for Use of a Data and
Safety Monitoring Board (DSMB) For Oversight of Clinical Trials Policy

When a monitor or monitoring board is organized, a description of it, its
charter or operating procedures (including a proposed meeting schedule and plan
for review of adverse events), and roster and curriculum vitae from all members
must be submitted to and approved by the COR before enrollment starts. The
Contractor will also ensure that the monitors and board members report any
conflicts of interest and the Contractor will maintain a record of this. The
Contractor will share conflict of interest reports with the CO and COR.

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

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

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

●Documentation of IRB or IEC approval, including OHRP federal wide number, IRB
or IEC registration number, and IRB and IEC name.

●IRB- or IEC- approved informed consent document, identified by version number,
date, or both and dates it is valid.

●Plans for the management of side effects.

●Procedures for assessing and reporting adverse events.

●Plans for data and safety monitoring (see above) and monitoring of the clinical
study site, pharmacy, and laboratory.

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

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

iv.Investigational New drug or Investigational Device Exemption Requirements

Consistent with federal regulations, clinical research projects involving the
use of investigational therapeutics, vaccines, or other medical interventions
(including licensed products and devices for a purpose other than that for which
they were licensed) in humans under a research protocol must be performed under
a Food and Drug Administration (FDA) investigational new drug (IND) or
investigational device exemption (IDE).

Exceptions must be granted in writing by FDA. If the proposed clinical trial
will be performed under an IND or IDE, the Contractor must provide BARDA with
the name and institution of the IND or IDE sponsor, the date the IND or IDE was
filed with FDA, the FDA IND or IDE number, any written comments from FDA, and
the written responses to those comments.

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

The Contractor must notify BARDA if the FDA places the study on clinical hold
and provide BARDA any written comments from FDA, written responses to the
comments, and documentation in writing that the hold has been lifted. The
Contractor must not use grant or contract funds during a clinical hold to fund
clinical studies that are on hold. The Contractor must not enter into any new
financial obligations related to clinical activities for the clinical trial on
clinical hold.

v.Required Time-Sensitive Notification

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

i.Expedited safety report of unexpected or life-threatening experience or death:

A copy of any report of unexpected or life-threatening experience or death
associated with the use of an IND drug, which must be reported to FDA by
telephone or fax as soon as possible but no later than seven

(7) days after

the IND sponsor’s receipt of the information, must be submitted to the COR
within 24 hours of FDA notification.

ii.Expedited safety reports of serious and unexpected adverse experiences: A
copy of any report of unexpected and serious adverse experience

associated with use of an IND drug or any finding from tests in laboratory
animals that suggests a significant risk for human subjects, which must be
reported in writing to FDA as soon as possible but no later than 15 days after
the IND sponsor’s receipt of the information, must be submitted to the COR
within 24 hours of FDA notification. For medical devices, adverse events should
be reported under the MedWatch (MDR) program with reporting timelines of 5 days
for serious adverse events or 30 days for reportable events.

iii.IDE reports of unanticipated adverse device effect:

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

iv.Expedited safety reports: Sent to the COR concurrently with the report to
FDA.

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

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

vi.Safety reporting for research not performed under an IND or IDE.

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

H.2.PROTECTION OF HUMAN SUBJECTS, HHSAR 352.270-4(b) (December 2015)

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a.The Contractor agrees that the rights and welfare of human subjects involved
in research under this contract shall be protected in accordance with 45 CFR
Part 46 and with the Contractor's current federal wide Assurance of Compliance
on file with the Office for Human Research Protections (OHRP), Department of
Health and Human Services. The Contractor further agrees to provide
certification at least annually that the Institutional Review Board has reviewed
and approved the procedures, which involve human subjects in accordance with 45
CFR Part 46 and the Assurance of Compliance.

b.The Contractor shall bear full responsibility for the performance of all work
and services involving the use of human subjects under this contract and shall
ensure that work is conducted in a proper manner and as safely as is feasible.
The parties hereto agree that the Contractor retains the right to control and
direct the performance of all work under this contract. The Contractor shall not
deem anything in this contract to constitute the Contractor or any
subcontractor, agent or employee of the Contractor, or any other person,
organization, institution, or group of any kind whatsoever, as the agent or
employee of the Government. The Contractor agrees that it has entered into this
contract and will discharge its obligations, duties, and undertakings and the
work pursuant thereto, whether requiring professional judgment or otherwise, as
an independent contractor without imputing liability on the part of the
Government for the acts of the Contractor or its employees.

c.Contractors involving other agencies or institutions in activities considered
to be engaged in research involving human subjects must ensure that such other
agencies or institutions obtain their own FWA if they are routinely engaged in
research involving human subjects or ensure that such agencies or institutions
are covered by the Contractors' FW’ via designation as agents of the institution
of via individual investigator agreements (see OHRP website at:
http//:www.hhs.gov/ohrp/policy/guidanceonalternativeofwa.pdf).

d.If at any time during the performance of this contract, the Contractor is not
in compliance with any of the requirements and/or standards stated in paragraphs
(a) and (b) above, the Contracting Officer may immediately suspend, in whole or
in part, work and further payments under this contract until the Contractor
corrects the noncompliance. The Contracting Officer may communicate the notice
of suspension by telephone with confirmation in writing. If the Contractor fails
to complete corrective action within the period of time designated in the
Contracting Officer's written notice of suspension, the Contracting Officer may,
after consultation with OHRP, terminate this contract in whole or in part.

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

The acquisition and supply of all human specimen material (including fetal
material) used under this contract shall be obtained by the Contractor in full
compliance with applicable Federal, State and Local laws and the provisions of
the Uniform Anatomical Gift Act in the United States, and no undue inducements,
monetary or otherwise, will be offered to any person to influence their donation
of human material.

The Contractor shall provide written documentation that all human materials
obtained as a result of research involving human subjects conducted under this
contract, by collaborating sites, or by subcontractors identified under this
contract, were obtained with prior approval by the Office for Human Research
Protections (OHRP) of an Assurance to comply with the requirements of

45 CFR 46 to protect human research subjects. This restriction applies to all
collaborating sites without OHRP- approved Assurances, whether domestic or
foreign, and compliance must be ensured by the Contractor.

Provision by the Contractor to the Contracting Officer of a properly completed
"Protection of Human Subjects Assurance Identification/IRB
Certification/Declaration of Exemption", Form OMB No. 0990-0263(formerly
Optional Form 310), certifying IRB review and approval of the protocol from
which the human materials were obtained constitutes the written documentation
required. The human subject certification can be met by submission of a
self-designated form provided that it contains the information required by the
"Protection of Human Subjects Assurance Identification/IRB
Certification/Declaration of Exemption", Form OMB No. 0990-0263 (formerly
Optional Form 310).

H.4.RESEARCH INVOLVING HUMAN FETAL TISSUE

All research involving human fetal tissue shall be conducted in accordance with
the Public Health Service Act, 42 U.S.C. 289g-1 and 289g-2. Implementing
regulations and guidance for conducting research on human fetal tissue may be
found at 45 CFR 46, Subpart B

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and http://grants1.nih.gov/grants/guide/notice-files/not93-235.html and any
subsequent revisions to this NIH Guide to Grants and Contracts ("Guide") Notice.

The Contractor shall make available, for audit by the Secretary, HHS, the
physician statements and informed consents required by 42 USC 289g-1(b) and (c),
or ensure HHS access to those records, if maintained by an entity other than the
Contractor.

H.5.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 (1-800- 447-8477). All telephone calls will
be handled confidentially. The e-mail address is Htips@os.dhhs.gov and the
mailing address is:

Office of Inspector General

Department of Health and Human Services TIPS HOTLINE

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

H.6.PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST ACTIVITIES

The Contractor acknowledges that U.S. Executive Orders and Laws, including but
not limited to 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.

H.7.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.

H.8.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).

H.9.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, and 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

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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.

H.10.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.

H.11.RESTRICTION ON ABORTIONS

The Contractor shall not use contract funds for any abortion.

H.12.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.

H.13.DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

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

H.14.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
Contractor performance; all data generated; all communications and
correspondence with regulatory agencies and bodies to include all audit
observations, inspection reports, milestone completion documents, and all
Offeror commitments and responses. Contractor shall provide the Government with
an electronic copy of all correspondence and submissions to the FDA within 5
business days of receipt. The Government shall acquire unlimited rights to all
data funded or furnished without proprietary restrictions under this contract in
accordance with FAR Subpart 27.4 and FAR Clause 52.227-14.

H.15.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.

H.16.ACKNOWLEDGMENT OF FEDERAL FUNDING

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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.

Publication and Publicity

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

In addition to the requirements set forth in HHSAR Clause 352.227-70,
Publications and Publicity incorporated by reference in Section I of this
contract, Section 507 of P.L. 104-208 mandates that Contractors funded with
Federal dollars, in whole or in part, acknowledge Federal funding when issuing
statements, press releases, requests for proposals, bid solicitations and other
documents. Contractors are required to state:

(1)The percentage and dollar amounts of the total program or project costs
financed with Federal money and;

(2)The percentage and dollar amount of the total costs financed by
non-governmental sources. For purposes of this contract “publication” is defined
as an issue of printed material offered for distribution or any communication or
oral presentation of information, including any manuscript or scientific meeting
abstract. Any publication containing data generated under this contract must be
submitted for BARDA review no less than thirty (30) calendar days for
manuscripts and fifteen (15) calendar days for abstracts

before submission for public presentation or publication. Contract support shall
be acknowledged in all such publications substantially as follows:

“This project has been funded in whole or in part with Federal funds from the
Department of Health and Human Services; Office of the Assistant Secretary for
Preparedness and Response; Biomedical Advanced Research and Development
Authority, under Contract No. HHSO100201800013C.”

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. With the exception of ad-hoc
press releases required by applicable law or regulations, the Contractor shall
ensure that the COR has received an advance copy of any press release related to
the contract not less than two (2) business days prior to the issuance of the
press release.

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

“This project has been funded in whole or in part with Federal funds from the
Department of Health and Human Services; Office of the Assistant Secretary for
Preparedness and Response; Biomedical Advanced Research and Development
Authority, under Contract No. HHSO100201800013C.”

H.17.PROHIBITION ON THE USE OF APPROPRIATED FUNDS FOR LOBBYING ACTIVITIES AND
HHSAR 352.203-70 ANTI-LOBBYING (December 2015)

Pursuant to the HHS annual appropriations acts, except for normal and recognized
executive- legislative relationships, the Contractor shall not use any HHS
contract funds for:

(a)Publicity or propaganda purposes;

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(b)The preparation, distribution, or use of any kit, pamphlet, booklet,
publication, electronic communication, radio, television, or video presentation
designed to support or defeat the enactment of legislation before the Congress
or any State or local legislature or legislative body, except in presentation to
the Congress or any state or local legislature

itself; or designed to support or defeat any proposed or pending regulation,

administrative action, or order issued by the executive branch of any state or
local government, except in presentation to the executive branch of any state or
local government itself; or

(c)Payment of salary or expenses of the Contractor, or any agent acting for the
Contractor, related to any activity designed to influence the enactment of
legislation, appropriations, regulation, administrative action, or Executive
order proposed or pending before the Congress or any state government, state
legislature or local legislature or legislative body, other than for normal and
recognized executive-

legislative relationships or participation by an agency or officer of a state,
local, or tribal government in policymaking and administrative processes within
the executive branch of that government.

(d)The prohibitions in subSections (a), (b), and (c) above shall include any
activity to advocate or promote any proposed, pending, or future federal, state,
or local tax increase, or any proposed, pending, or future requirement for, or
restriction on, any legal consumer product, including its sale or marketing,
including, but not limited to, the

advocacy or promotion of gun control.

H.18.PRIVACY ACT APPLICABILITY

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
https://www.gpo.gov/fdsys/granule/CFR-2007-title45-vol1/CFR-2007-title45-vol1-
part5b

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

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

H.19.LABORATORY LICENSE REQUIREMENTS

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

H.20.QUALITY ASSURANCE (QA) AUDIT REPORTS

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

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

●Contractor shall notify the COR and CO within five (5) business days of report
completion.

H.21.BARDA AUDITS

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Contractor shall accommodate periodic or reasonable ad hoc site visits during
normal business hours by the Government with forty- eight (48) hours advance
notice. 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
ten (10) business days.

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

H.22.RESTRICTION ON EMPLOYMENT OF UNAUTHORIZED ALIEN WORKERS

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

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

H.23.NOTIFICATION OF CRITICAL PROGRAMMATIC CONCERNS, RISKS, OR POTENTIAL RISKS

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

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

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

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

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

H.24.DISSEMINATION OF INFORMATION (May 2004)

Other than scientific and technical Sections for which the contractor can assert
a copyright under FAR Clause 52.227-14 I no information related to data obtained
under this contract shall be released or publicized without the prior written
consent of the Contracting Officer. In the event that the contractor seeks to
publicize data through a scientific or technical Section, the contractor shall
provide BARDA, through the COR, with a minimum of thirty (30) business days to
review the Section prior to publication.

H.25.REGISTRATION WITH THE SELECT AGENT PROGRAM FOR WORK INVOLVING THE
POSSESSION, USE, AND/OR TRANSFER OF SELECT BIOLOGICAL AGENTS OR TOXINS

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

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

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

For prime or subcontract awards to foreign institutions who possess, use, and/or
transfer Select Agents under this contract, the institution must provide
information satisfactory to the Government that a process equivalent to that
described in 42 CFR 73
(https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=8a4be60456973b5ec6bef5dfeaffd49a&r=PART&n=42y1.0.1.6.61)
for U.S. institutions is in place and will be administered on behalf of all
Select Agent work sponsored by these funds before using these funds for any work
directly involving the Select Agents. The Contractor must provide information
addressing the following key elements appropriate for the foreign institution:
safety, security, training, procedures for ensuring that only
approved/appropriate individuals have access to the Select Agents, and any
applicable laws, regulations and policies equivalent to 42 CFR 73. The
Government will assess the policies and procedures for comparability to the U.S.
requirements described in 42 CFR Part 73. When requested by the contracting
officer, the Contractor shall provide key information delineating any laws,
regulations, policies, and procedures applicable to the foreign institution for
the safe and secure possession, use, and transfer of Select Agents. This
includes summaries of safety, security, and training plans, and applicable laws,
regulations, and policies. For the purpose of security risk assessments, the
Contractor must provide the names of all individuals at the foreign institution
who will have access to the Select Agents and procedures for ensuring that only
approved and appropriate individuals have access to Select Agents under the
contract.

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

H.26.MANUFACTURING STANDARDS

The Good Manufacturing Practice Regulations (GMP)(21 CFR Parts 820) will be the
standard to be applied for manufacturing, processing, packaging, storage and
delivery of this product.

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

H.27.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 such as an overall project summary report and/or slides will be
required when the IPRs are conducted. The Contractor’s success in completing the
required tasks under each work segment must be demonstrated through the
Deliverables and Milestones specified under Section F. Those deliverables will
constitute the basis for the Government’s decision, at its sole discretion, to
proceed with the work segment, or institute changes to the work segment, or
terminate the work segment.

IPRs may be scheduled at the discretion of the 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
business days prior to the IPR. Subsequently, the contractor will be requested
to provide a revised/final presentation to the Contracting Officer at least 10
business days prior to the IPR.

H.28.HUMAN SUBJECTS

The Contractor shall submit all human clinical protocols and informed consent
documents to BARDA for review and comment prior to submission to another entity.

Research involving human subjects shall not be conducted under this contract
until the study protocol has been approved by the Department of Health and Human
Services, written notice of such approval has been provided by the CO, and the
Contractor has provided to the CO a properly completed “Protection of Human
Subjects Assurance Identification/IRB Certification/Declaration of Exemption”,
Form OMB No. 0990-0263 (formerly Optional Form 310) certifying IRB review and
approval of the protocol. The human

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

subject certification can be met by submission of the Contractor’s
self-designated form, provided that it contains the information required by the
“Protection of Human Subjects Assurance Identification/IRB
Certification/Declaration of Exemption”, Form OMB No. 0990-0263 (formerly
Optional Form 310).

When research involving Human Subjects will take place at collaborating sites or
other performance sites, the Contractor shall obtain, and keep on file, a
properly completed “Protection of Human Subjects Assurance Identification/IRB
Certification/Declaration of Exemption”, Form OMB No. 0990-0263 (formerly
Optional Form 310) certifying IRB review and approval of the research.

H.29.SHARING RESEARCH DATA

The Contractor’s data sharing plan, due date to be determined at contract award,
is hereby incorporated by reference. The Contractor agrees to adhere to its plan
and shall request prior approval of the Contracting Officer for any changes in
its plan.

BARDA endorses the sharing of final research data to serve health. This contract
is expected to generate research data that must be shared with the public and
other researchers.

BARDA recognizes that data sharing may be complicated or limited, in some cases,
by institutional policies, local IRB rules, as well as local, state and Federal
laws and regulations, including the Privacy Rule (see HHS-published
documentation on the Health Information Privacy at
http://www.hhs.gov/ocr/privacy/index.html). The rights and privacy of people who
participate in BARDA- funded research must be protected at all times; thus, data
intended for broader use should be free of identifiers that would permit
linkages to individual research participants and variables that could lead to
deductive disclosure of the identity of individual subjects.

H.30.CONTINUED BAN ON FUNDING ABORTION AND CONTINUED BAN ON FUNDING OF HUMAN
EMBRYO RESEARCH, HHSAR 352.270-13 (December 2015)

a.The Contractor shall not use any funds obligated under this contract for any
abortion.

b.The Contractor shall not use any funds obligated under this contract for the
following:

i.The creation of a human embryo or embryos for research purposes; or

ii.Research in which a human embryo or embryos are destroyed,

discarded, or knowingly subjected to risk of injury of death greater than that
allowed for research on fetuses in utero under 45 CFR part 46 and Section 498(b)
of the Public Health Service Act (42 U.S.C. 289g(b)).

c.The term ``human embryo or embryos’’ includes any organism, not protected as a
human subject under 45 CFR part 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 of human diploid cells.

d.The Contractor shall not use any Federal funds for the cloning of human
beings.

H.31.PUBLIC ACCESS TO ARCHIVED PUBLICATIONS RESULTING FROM ASPR FUNDED RESEARCH

All ASPR-funded investigators shall submit to the NIH National Library of
Medicine’s (NLM) PubMed Central (PMC) an electronic version of the author’s
final manuscript, upon acceptance for publication, of any peer-reviewed
scientific publications resulting from research supported in whole or in part
with Federal funds from the Department of Health and Human Services; Office of
the Assistant Secretary for Preparedness and Response. ASPR defines the author’s
final manuscript as the final version accepted for journal publication, and
includes all modifications from the publishing peer review process. The PMC
archive will preserve permanently these manuscripts for use by the public,
health care providers, educators, scientists, and ASPR. The Policy directs
electronic submissions to the NIH/NLM/PMC: http://www.pubmedcentral.nih.gov.

H.32.INSTITUTIONAL RESPONSIBILITY REGARDING CONFLICTING INTERESTS OF
INVESTIGATORS

The Contractor shall comply with the requirements of 45 CFR Part 94, Responsible
Prospective

Contractors, which promotes objectivity in research by establishing standards to
ensure that investigators (defined as the principal investigator and any other
person who is responsible for the design, conduct, or reporting of research
funded under BARDA contracts) will not be biased by any conflicting financial
interest. 45 CFR Part 94 is available at the following Web site:

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

https://www.ecfr.gov/cgi-bin/text-idx?tpl=/ecfrbrowse/Title45/45cfr94_main_02.tpl

As required by 45 CFR Part 94, the Contractor shall, at a minimum:

a.Maintain a written, enforceable policy on conflict of interest that complies
with 45 CFR Part 94 and inform each investigator of the policy, the
investigator’s reporting responsibilities, and the applicable regulations. The
Contractor must take reasonable steps to ensure that investigators working as
collaborators or subcontractors comply with the regulations.

b.Designate an official(s) to solicit and review financial disclosure statements
from each investigator participating in BARDA- funded research. Based on
established guidelines consistent with the regulations, the designated
official(s) must determine whether a conflict of interest exists, and if so,
determine what actions should be taken to manage, reduce, or eliminate such
conflict. A conflict of interest exists when the designated official(s)
reasonably determines that a Significant Financial Interest could directly and
significantly affect the design, conduct, or reporting of the BARDA-funded
research. The Contractor may require the management of other conflicting
financial interests in addition to those described in this paragraph, as it
deems appropriate. Examples of conditions or restrictions that might be imposed
to manage actual or potential conflicts of interests are included in 45 CFR Part
94, under Management of Conflicting Interests.

c.Require all financial disclosures to be updated during the period of the
award, either on an annual basis or as new reportable Significant Financial
Interests are obtained.

d.Maintain records, identifiable to each award, of all financial disclosures and
all actions taken by the Contractor with respect to each conflicting interest 3
years after final payment or, where applicable, for the other time periods
specified in 48 CFR Part 4, subpart 4.7, Contract Records Retention.

e.Establish adequate enforcement mechanisms and provide for sanctions where
appropriate.

If a conflict of interest is identified, the Contractor shall report to the
Contracting Officer, the existence of the conflicting interest found. This
report shall be made and the conflicting interest managed, reduced, or
eliminated, at least on a temporary basis, within sixty (60) days of that
identification.

If the failure of an investigator to comply with the conflict of interest policy
has biased the design, conduct, or reporting of the BARDA-funded research, the
Contractor must promptly notify the Contracting Officer of the corrective action
taken or to be taken. The Contracting Officer will take appropriate action or
refer the matter to the Contractor for further action, which may include
directions to the Contractor on how to maintain appropriate objectivity in the
funded research.

The Contracting Officer may at any time inquire into the Contractor’s procedures
and actions regarding conflicts of interests in BARDA-funded research, including
a review of all records pertinent to compliance with 45 CFR Part 94. The
Contracting Officer may require submission of the records or review them on
site. On the basis of this review, the Contracting Officer may decide that a
particular conflict of interest will bias the objectivity of the BARDA-funded
research to such an extent that further corrective action is needed or that the
Contractor has not managed, reduced, or eliminated the conflict of interest. The
issuance of a Stop Work Order by the Contracting Officer may be necessary until
the matter is resolved.

If the Contracting Officer determines that BARDA-funded clinical research, whose
purpose is to evaluate the safety or effectiveness of a drug, medical device, or
treatment, has been designed, conducted, or reported by an investigator with a
conflict of interest that was not disclosed or managed, the Contractor must
require disclosure of the conflict of interest in each public presentation of
the results of the research.

H-33 FOREIGN TRANSFER OF ASSETS OR TECHNOLOGY

This clause shall remain in effect during the term of the Contract and for five
(5) years thereafter.

a.Definitions

AFFILIATES: Associated business concerns, non-profit organizations, or
individuals if, directly or indirectly, (1) either one controls or can control
the other; or (2) a third party controls or can control both.

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

ASSET(S): Tangible or intangible manifestations of technologies having economic
value and capable of being conveyed between economic or Governmental entities
that is the focus/scope of development by the U.S. Government (“USG”) and
Contactor in this Contract.

ASSET(S): Tangible or intangible manifestations of technologies having economic
value and capable of being conveyed between economic or Governmental entities
that is the focus/scope of development by the U.S. Government (the “USG”) and
Contactor in this Contract.

FOREIGN FIRM OR INSTITUTION: A firm or institution organized or existing under
the laws of a country other than the United States of America (U.S.), its
territories, or possessions. The term includes, for purposes of this Contract,
any agency or instrumentality of a foreign government; and firms, institutions
or business organizations which are owned or substantially controlled by foreign
governments, firms, institutions, or individuals.

TECHNOLOGY: Technical Data, Computer Software, manufactured materials and
Subject Inventions funded by the USG under this Contract. Technology also
includes contractor know how and personnel expertise, as well as other Assets
necessary to assure successful completion of this Contract.

U.S. FIRM OR INSTITUTION: A firm or institution organized or existing under the
laws of the United States, its territories, or possessions. The term includes,
for purposes of this Contract, any agency or instrumentality of the USG; and
firms, institutions or business organizations which are owned or substantially
controlled by U.S. citizens, firms, institutions, governmental agencies or
individuals.

b.General

The Parties agree that research findings and technological developments made
under this Contract constitute an investment by the USG on behalf of its
citizens in the interest of their economic and national health security. These
investments are made for the primary benefit of the citizenry of the U.S. with
those same benefits potentially accruing to the people of all nations.
Therefore, the USG has a fiduciary responsibility to protect the full invested
value of the Assets and Technology developed under this Contract. The USG is
also cognizant of the duty the Contractor has to its shareholders and other
stakeholders with a vested interested in the economic success of the Contractor.
At times both parties are aware their respective interests may diverge.
Therefore, in the course of conducting business though the Contract, access to
technology developments under this Contract by Foreign Firms or Institutions
must be carefully considered.

c.Export Controls

Contractor agrees to comply with all applicable laws regarding export controls
and not to export any Asset or Technology to any U.S. embargoed countries.

d.Post-award Transfer of Ownership of Assets or Technology

The Contractor shall provide notice to the Contracting Officer and COR within
three (3) business days of any discussions of a proposed transfer of ownership
or establishment of a licensing agreement of any Asset or Technology funded
under this Contract from the Contractor to a Foreign Firm or Institution. Notice
will also be given within three (3) business days of any discussions of a
proposed transfer of operational, corporate, or economic control of Assets and
Technology funded under this Contract to Foreign Firms or Institutions. This
Article shall not apply to transfers by the Contractor to Affiliated entities of
the Contractor, as well as technology transfers for the purposes of
manufacturing in accordance with the Statement of Work.

Prior to transferring any Asset funded by the USG under this Contract, the
Contractor should carefully review the USG rights under FAR Subpart 42.12
pertaining to Novation, specifically FAR section 42.1204. That provision
provides that the USG may recognize a third party assignment only if the
transfer of Assets and Technology is determined to be in the USG’s interests.
The Contractor should be aware that the USG is under no obligation to recognize
a successor in interest. If the Contracting Officer determines that a transfer
of Assets and Technology may have adverse consequences to the economic
well-being or national health security interests of the U.S., the Contractor,
and the Contracting Officer shall jointly endeavor to find alternatives to the
proposed transfer which obviate or mitigate potential adverse consequences of
the transfer but which may provide substantially equivalent benefits to the

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

Contractor.

In addition to the USG licensing rights to subject inventions and technical data
funded under this Contract, see FAR clause 52.227-11 (Patent Rights-Ownership by
the Contractor) and FAR Clause 52.227-14 (Rights in Data - General), the USG
shall have a first right of refusal for the purchase of the Asset and/or
Technology funded under the Contract. The USG may waive this first right of
refusal in writing submitted to the Contractor within ninety (90) calendar days
of the initial notification to the USG of the Contractor’s intent to conduct any
form of Asset or corporate transfer.

Except for transfers to affiliates of the Contractor, including those entities
necessary to complete the Statement of Work, the Contractor shall provide
written notice to the Contracting Officer and COR of the scheduled transfer to a
Foreign Firm or Institution at least ninety (90) calendar days prior to the
scheduled date of transfer. Such notice shall cite this Article and shall
specifically identify the Asset or Technology proposed for the transfer and the
general terms of the transfer. No transfer shall take place without written
concurrence from the Contracting Officer.

e.Transfer to a Prohibited Source

In the event of a transfer of an Asset and/or Technology by the Contractor to a
Foreign Firm or Institution which is identified as a Prohibited Source pursuant
to Federal Acquisition Regulation Subpart 25.7: (a) the Government may terminate
this contract for cause and (b) the license rights to the technical data and
subject invention under the relevant FAR IP Clauses (FAR Clause 52.227-11 and
FAR Clause 52-227-14) shall survive the termination. Upon request of the USG,
the Contractor shall provide written confirmation of such licenses.

f.Lower Tier Agreements

The Contractor shall include this Article, suitably modified, to identify the
Parties, in all subcontracts or lower tier agreements, regardless of tier.

PART II – CONTRACT CLAUSES SECTION I – CONTRACT CLAUSES

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

Graphic [mrns-20200930xex10d3044.jpg]

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: http://www.acquisition.gov/far.
HHSAR clauses at http://www.hhs.gov/policies/hhsar/subpart352.html

Graphic [mrns-20200930xex10d3044.jpg]

General Clauses for Cost-Reimbursement Research and Development Contract

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

FAR Clause

Date

Clause Title

52.202-1

Jun 2020

Definitions

52.203-3

Apr 1984

Gratuities

52.203-5

May 2014

Covenant Against Contingent Fees

52.203-6

Jun 2020

Restrictions on Subcontractor Sales to the Government

52.203-7

Jun 2020

Anti-Kickback Procedures

52.203-8

May 2014

Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity

52.203-10

May 2014

Price or Fee Adjustment for Illegal or Improper Activity

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

52.203-11

Sept 2007

Certification and Disclosure Regarding Payments to Influence Certain Federal
Transactions

52.203-12

Jun 2020

Limitation on Payments to Influence Certain Federal Transactions

52.203-13

Jun 2020

Contractor Code of Business Ethics and Conduct

52.203-14

Jun 2020

Display of Hotline Poster(s)

52.203-17

Jun 2020

Contractor Employee Whistleblower Rights and Requirement To Inform Employees of
Whistleblower Rights

52.204-4

May 2011

Printed or Copied Double-Sided on Postconsumer Fiber Content Paper

52.204-5

Oct 2014

Women-Owned Business (Other Than Small Business)

52.204-7

Oct 2016

System for Award Management

52.204-10

Jun 2020

Reporting Executive Compensation and First-Tier Subcontract Awards

52.204-13

Oct 2016

System for Award Management Maintenance

52.204-16

Aug 2020

Commercial and Government Entity Code Reporting

52.204-17

Aug 2020

Ownership of Control or Offeror

52.204-18

Aug 2020

Commercial and Government Entity Code Maintenance

52.207-1

May 2006

Notice of Standard Competition

52.209-5

Oct 2015

Certification Regarding Responsibility Matters

52.209-6

Jun 2020

Protecting the Government’s Interests When Subcontracting With Contractors
Debarred, Suspended, or Proposed for Debarment

52.209-9

Jul 2013

Updates of Publicly Available Information Regarding Responsibility Matters

52.209-10

Nov 2015

Prohibition on Contracting with Inverted Domestic Corporations

52.210-1

Jun 2020

Market Research

52.211-5

Aug 2000

Material Requirements

52.215-2

Jun 2020

Audit and Records – Negotiation

52.215-8

Oct 1997

Order of Precedence – Uniform Contract Format

52.215-10

Aug 2011

Price Reduction for Defective Cost or Pricing Data

52.215-11

Jun 2020

Price Reduction for Defective Certified Cost or Pricing Data

—Modifications.

52.215-12

Jun 2020

Subcontractor Certified Cost or Pricing Data

52.215-13

Jun 2020

Subcontractor Certified Cost or Pricing Data—Modifications

52.215-14

Jun 2020

Integrity of Unit Prices (Over the Simplified Acquisition Threshold

52.215-15

Oct 2010

Pension Adjustments and Asset Reversions

52.215-16

June 2003

Facilities Capital Cost of Money

52.215-17

Oct 1997

Waiver of Facilities Capital Cost of Money

52.215-18

Jul 2005

Reversion or Adjustment of Plans for Postretirement Benefits (PRB) other than
Pensions

52.215-19

Oct 1997

Notification of Ownership Changes

52.215-20

Oct 2010

Requirements for Certified Cost or Pricing Data and Data Other Than Certified
Cost or Pricing Data

52.215-21

Jun 2020

Requirements for Certified Cost or Pricing Data and Data Other Than Certified
Cost or Pricing Data – Modifications

52.215-22

Oct 2009

Limitations on Pass-Through Charges—Identification of Subcontract Effort

52.215-23

Jun 2020

Limitations on Pass-Through Charges

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

52.216-7

Aug 2018

Allowable Cost and Payment

52.216-8

Jun 2011

Fixed Fee

52.219-8

Nov 2018

Utilization of Small Business Concerns

52.219-9

Jun 2020

Small Business Subcontracting Plan

52.219-10

Oct 2014

Incentive Subcontracting Program

52.219-14

Mar 2020

Limitations on Subcontracting

52.219-16

Jan 1999

Liquidated Damages – Subcontracting Plan

52.219-28

May

2020

Post-Award Small Business Program Representation

52.222-3

Jun 2003

Convict Labor

52.222-21

Apr 2015

Prohibition of Segregated Facilities

52.222-24

Feb 1999

Pre-award On-Site Equal Opportunity Compliance Evaluation

52.222-25

Apr 1984

Affirmative Action Compliance

52.222-26

Sept 2016

Equal Opportunity

52.222-35

Jun 2020

Equal Opportunity for Veterans ($150,000 or more)

52.222-36

Jun 2020

Equal Opportunity for Workers with Disabilities

52.222-37

Jun 2020

Employment Reports on Veterans

52.222-38

Feb 2016

Compliance with Veterans’ Employment Reporting Requirements

52.222-40

Dec 2010

Notification of Employee Rights Under the National Labor Relations Act

52.222-50

Mar 2015

Combating Trafficking in Persons

52.222-54

Oct 2015

Employment Eligibility Verification

52.222-59

Dec 2016

Compliance With Labor Laws (Executive Order 13673)

52.222-60

Oct 2016

Paycheck Transparency (Executive Order 13673)

52.222-61

Dec 2016

Arbitration of Contractor Employee Claims (Executive Order 13673)

52.222-62

Jan 2017

Paid Sick Leave Under Executive Order 13706

52.223-6

May 2001

Drug-Free Workplace

52.223-18

Jun 2020

Encouraging Contractor Policy to Ban Text Messaging While Driving

52.225-13

Jun 2008

Restrictions on Certain Foreign Purchases

52.225-25

Jun 2020

Prohibition on Contracting with Entities Engaging in Certain Activities or
Transactions Relating to Iran—Representation and Certifications

52.226-1

Jun 2000

Utilization of Indian Organizations and Indian-Owned Economic Enterprises.

52.227-1

Jun 2020

Authorization and Consent, Alternate 1 (APR 1984)

52.227-2

Jun 2020

Notice and Assistance Regarding Patent and Copyright Infringement

52.227-3

Apr 1984

Patent Indemnity

52.227-11

May 2014

Patent Rights – Ownership by the Contractor

52.227-14

May 2014

Rights in Data – General

52.227-14

Alt. II

Dec 2007

Rights in Data – General – Limited Rights Notice

52.227-15

Dec 2007

Representation of Limited Rights Data and Restricted Computer Software

52.227-16

June 1987

Additional Data Requirements

52.228-7

Mar 1996

Insurance – Liability to Third Persons

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

52.230-2

Jun 2020

Cost Accounting Standards

52.230-3

Jun 2020

Disclosure and Consistency of Cost Accounting Practices

52.230-6

Jun 2010

Administration of Cost Accounting Standards

52.230-7

Apr 2005

Proposal Disclosure—Cost Accounting Practice Changes

52.232-9

Apr 1984

Limitation on Withholding of Payments

52.232-17

May 2014

Interest

52.232-20

Apr 1984

Limitation of Cost

52.232-23

May 2014

Assignment of Claims

52.232-25

Jan 2017

Prompt Payment

52.232-33

Jul 2013

Payment by Electronic Funds Transfer–System for Award Management

52.232.39

Jun 2013

Unenforceability of Unauthorized Obligations

52.232-40

Dec 2013

Providing Accelerated Payments to Small Business Subcontractors

52.233-1

May 2014

Disputes

52.233-3

Aug 1996

Protest After Award, Alternate 1 (Jun 1985)

52.233-4

Oct 2004

Applicable Law for Breach of Contract Claim

52.242-1

Apr 1984

Notice of Intent to Disallow Costs

52.242-3

May 2014

Penalties for Unallowable Costs

52.242-4

Jan 1997

Certification of Final Indirect Costs

52.242-13

Jul 1995

Bankruptcy

52.243-2

Aug 1987

Changes – Cost-Reimbursement Alternate V (Apr 1984)

52.244-2

Jun 2020

Subcontracts, Alternate 1 (Jun 2007)

52.244-5

Dec 1996

Competition in Subcontracting

52.244-6

Jun 2020

Subcontracts for Commercial Items

52.245-1

Apr 2012

Government Property

52.245-9

Apr 2012

Use and Charges

52.246-23

Feb 1997

Limitation of Liability

52.249-6

May 2004

Termination (Cost-Reimbursement)

52.249-14

Apr 1984

Excusable Delays

52.253-1

Jan 1991

Computer Generated Forms

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

HHSAR CLAUSE

352.203-70

Dec 2015

Anti-Lobbying

352.208-70

Dec 2015

Printing and Duplication

352.211-3

Dec 2015

Paperwork Reduction Act

352.219-70

Dec 2015

Mentor-Protégé Program

352.219-71

Dec 2015

Mentor-Protégé Program Reporting Requirements

352.222-70

Dec 2015

Contractor Cooperation in Equal Employment Opportunity Investigations

352.223-70

Dec 2015

Safety and Health

352.224-70

Dec 2015

Privacy Act

352.224-71

Dec 2016

Confidential Information

352.227-70

Dec 2015

Publications and Publicity

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

352.231-70

Dec 2015

Salary Rate Limitation

352.233-71

Dec 2015

Litigation and Claims

352.237-75

Dec 2015

Key Personnel

352.239-74

Dec 2015

Electronic and Information Technology Accessibility

352.270-9

Dec 2015

Non-discrimination for Conscience

I.2.ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT

This contract incorporates the following clauses in full text. FEDERAL
ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:

FAR Clause 52.217-9, Option to Extend the Term of the Contract (Mar 2000)

The Government may extend the term of this contract by written notice to the
Contractor within 15 days provided that the Government gives the Contractor a
preliminary written notice of its intent to extend at least 30 days before the
contract expires. The preliminary notice does not commit the Government to an
extension.

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

•The total duration of this contract, including the exercise of any options
under this clause, shall not exceed 10 years.

FAR Clause 52.219-28, Post-Award Small Business Program Representation (May
2020) 52.219-28 Post-Award Small Business Program Rerepresentation.

As prescribed in 19.309(c)(1), insert the following clause:

Post-Award Small Business Program Rerepresentation (May 2020)

(a)Definitions. As used in this clause—

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

Small business concern means a concern, including its affiliates, that is
independently owned and operated, not dominant in the field of operation in
which it is bidding on Government contracts, and qualified as a small business
under the criteria in 13 CFR part 121 and the size standard in paragraph (d) 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 any of the small business concerns
identified in 19.000(a)(3) prior to award of this contract, the Contractor shall
rerepresent its size and socioeconomic status according to paragraph (f) of this
clause or, if applicable, paragraph (h) of this clause, upon 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.

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(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)If the Contractor represented that it was any of the small business concerns
identified in 19.000(a)(3) prior to award of this contract, the Contractor shall
rerepresent its size and socioeconomic status according to paragraph (f) of this
clause or, if applicable, paragraph (h) of this clause, when the Contracting
Officer explicitly requires it for an order issued under a multiple-award
contract.

(d)The Contractor shall rerepresent its size status in accordance with the size
standard in effect at the time of this rerepresentation that corresponds to the
North American Industry Classification System (NAICS) code(s) assigned to this
contract. The small business size standard corresponding to this NAICS code(s)
can be found at https://www.sba.gov/document/support--table-size-standards.

(e)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.

(f)Except as provided in paragraph (h) of this clause, the Contractor shall make
the representation(s) required by paragraph (b) and

(c)of this clause by validating or updating all its representations in the
Representations and Certifications section of the System for Award Management
(SAM) and its other data in SAM, 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, or
with its offer for an order (see paragraph (c) of this clause), that the data
have been validated or updated, and provide the date of the validation or
update.

(g)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 (f) or (h) of this clause.

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

(1)The Contractor represents that it □ is, □ is not a small business concern
under NAICS Code assigned to contract number

.

(2)[ Complete only if the Contractor represented itself as a small business
concern in paragraph (h)(1) of this clause.] The Contractor represents that it □
is, □ is not, a small disadvantaged business concern as defined in 13 CFR
124.1002.

(3)[ Complete only if the Contractor represented itself as a small business
concern in paragraph (h)(1) of this clause. ] The Contractor represents that it
□ is, □ is not a women-owned small business concern.

(4)Women-owned small business (WOSB) concern eligible under the WOSB Program.
[Complete only if the Contractor represented itself as a women-owned small
business concern in paragraph (h)(3) of this clause.] The Contractor represents
that—

(i)It □ is, □ 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, □ is not a joint venture that complies with the requirements of 13
CFR part 127, and the representation in paragraph (h)(4)(i) of this clause is
accurate for each WOSB concern eligible under the WOSB Program participating in
the joint venture. [The Contractor shall enter the name or names of the WOSB
concern eligible under the WOSB Program and other small businesses that are

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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 Contractor represented itself as a women-owned
small business concern eligible under the WOSB Program in (h)(4) of this clause.
] The Contractor represents that—

(i)It □ is, □ 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, □ is not a joint venture that complies with the requirements of 13
CFR part 127, and the representation in paragraph (h)(5)(i) of this clause is
accurate for each EDWOSB concern participating in the joint venture. [The
Contractor 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.

(6)[ Complete only if the Contractor represented itself as a small business
concern in paragraph (h)(1) of this clause. ] The Contractor represents that it
□ is, □ is not a veteran-owned small business concern.

(7)[ Complete only if the Contractor represented itself as a veteran-owned small
business concern in paragraph (h)(6) of this clause.] The Contractor represents
that it □ is, □ is not a service-disabled veteran-owned small business concern.

(8)[ Complete only if the Contractor represented itself as a small business
concern in paragraph (h)(1) of this clause. ] The Contractor represents that—

(i)It □ is, □ 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, □ is not a HUBZone joint venture that complies with the
requirements of 13 CFR part 126, and the representation in paragraph (h)(8)(i)
of this clause is accurate for each HUBZone small business concern participating
in the HUBZone joint venture. [The Contractor 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.

[Contractor to sign and date and insert authorized signer's name and title.]
(End of clause)

FAR 52.204-21 Basic Safeguarding of Covered Contractor Information Systems (Jun
2016)

(a)Definitions. As used in this clause--

“Covered contractor information system” means an information system that is
owned or operated by a contractor that processes, stores, or transmits Federal
contract information.

“Federal contract information” means information, not intended for public
release, that is provided by or generated for the Government under a contract to
develop or deliver a product or service to the Government, but not including
information provided by the Government to the public (such as on public Web
sites) or simple transactional information, such as necessary to process
payments.

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“Information” means any communication or representation of knowledge such as
facts, data, or opinions, in any medium or form, including textual, numerical,
graphic, cartographic, narrative, or audiovisual (Committee on National Security
Systems Instruction (CNSSI) 4009).

“Information system” means a discrete set of information resources organized for
the collection, processing, maintenance, use, sharing, dissemination, or
disposition of information (44 U.S.C. 3502).

“Safeguarding” means measures or controls that are prescribed to protect
information systems.

(b)Safeguarding requirements and procedures.

(1)The Contractor shall apply the following basic safeguarding requirements and
procedures to protect covered contractor information systems. Requirements and
procedures for basic safeguarding of covered contractor information systems
shall include, at a minimum, the following security controls:

(i)Limit information system access to authorized users, processes acting on
behalf of authorized users, or devices (including other information systems).

(ii)Limit information system access to the types of transactions and functions
that authorized users are permitted to execute.

(iii)Verify and control/limit connections to and use of external information
systems.

(iv)Control information posted or processed on publicly accessible information
systems.

(v)Identify information system users, processes acting on behalf of users, or
devices.

(vi)Authenticate (or verify) the identities of those users, processes, or
devices, as a prerequisite to allowing access to organizational information
systems.

(vii)Sanitize or destroy information system media containing Federal Contract
Information before disposal or release for reuse.

(viii)Limit physical access to organizational information systems, equipment,
and the respective operating environments to authorized individuals.

(ix)Escort visitors and monitor visitor activity; maintain audit logs of
physical access; and control and manage physical access devices.

(x)Monitor, control, and protect organizational communications (i.e.,
information transmitted or received by organizational information systems) at
the external boundaries and key internal boundaries of the information systems.

(xi)Implement subnetworks for publicly accessible system components that are
physically or logically separated from internal networks.

(xii)Identify, report, and correct information and information system flaws in a
timely manner.

(xiii)Provide protection from malicious code at appropriate locations within
organizational information systems.

(xiv)Update malicious code protection mechanisms when new releases are
available.

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(xv)Perform periodic scans of the information system and real-time scans of
files from external sources as files are downloaded, opened, or executed.

(2)Other requirements. This clause does not relieve the Contractor of any other
specific safeguarding requirements specified by Federal agencies and departments
relating to covered contractor information systems generally or other Federal
safeguarding requirements for controlled unclassified information (CUI) as
established by Executive Order 13556.

(c)Subcontracts. The Contractor shall include the substance of this clause,
including this paragraph (c), in subcontracts under this contract (including
subcontracts for the acquisition of commercial items, other than commercially
available off-the-shelf items), in which the subcontractor may have Federal
contract information residing in or transiting through its information system.

(End of clause)

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS SECTION J - LIST OF
ATTACHMENTS

The following documents are attached and incorporated in this contract:

1.Statement of Work

Statement of Work, dated 08//5/2020, 10 pages

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

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

3.Sample Invoice, 1 page

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

5.Instructions for Completing Financial Report of Individual Project/Contract, 2
pages

6.Inclusion Enrollment Report

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

7.Research Patient Care Costs

Research Patient Care Costs, 1 page.

8.Report of Government Owned, Contractor Held Property

Graphic [mrns-20200930xex10d3046.jpg]
Graphic [mrns-20200930xex10d3047.jpg]
Graphic [mrns-20200930xex10d3048.jpg]
Graphic [mrns-20200930xex10d3049.jpg]
Graphic [mrns-20200930xex10d3050.jpg]
Graphic [mrns-20200930xex10d3051.jpg]
Graphic [mrns-20200930xex10d3052.jpg]
Graphic [mrns-20200930xex10d3051.jpg]

Report of Government Owned, Contractor Held Property,1 page. Located at:

9.Contract Milestones Table, 2 pages.

END OF CONTRACT 75A50120C00159

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