AWARD/CONTRACT
2. CONTRACT (Proc. hist 'dent) NO.

1. THIS CONTRACT IS A RAT ED ORDER
UNDER DPAS (15 CFR 700)
3. EFFECTIVE DATE

13 Oct 2020

VV911KF2190001
CODE W911NF

5. ISSUED BY

IRAT
RATING

PAGE OF PAGES
1 I
40
4. REQUISITION/PURCHASE REQUEST/PROJECT NO.
0011560601

6. ADMINISTERED BY (Jothersbcgt item 5)

CODE' SCI514A

DCMA SAN D EGO
9174 SKY PARK CT, SUITE 1(l)SAND EGO CA921214363

US ARMY ACC-APG-RTP VY911NF
803 PARK OFFICE DRIVESUITE 4229
RESEARCH TRIANGLE PARK NC 27709

7. NAME AND ADDRESS OF CONTRACTOR

SCD: C

8. DELIVERY[ X ] FOB ORIGIN,_._., street city, cotrit(v; state and 49 code)04,

CUE NC.
11100 ROSELLE ST STE A
SAN D EGO CA 92'121-1210[] OTHER

10 SUBMET1NVOICESCODE 7VFK0
11. SHIP TO/MARK FOR

FACILITY CODE
CODE VIE6XNH

13. AUTHORITY FOR USING OTHER THAN FULL AND OPEN

14. ACCOUNTING AND APPROPRIATION DATA

15A ITEM NO.

] 41 U.S.C. 253(c)()

15B. SUPPLIES/ SERVICES,

CODE H00829

12. PAYMENT WILL BE MADE BY
D FAS COW MEIMEST ENTTREM ENT OPERATIONSDFAS-COMEST ENTITLEMENT OPERATIONSPO BOX182381
COLUMBUS OH 43218-2381

) [

ITEM

(4 copies unkss otherwise spec fled)
TO THE ADDRESSSHOWN IN:

JPM MEDICALJPM CBRN MEDICAL
1564 FREEDMAN DRIVE
FORT DETRICK MD MD 21702

COMPETITION:[] 10 U.S.C. 2304(c)((See bebw)

9 DISCOUNT FOR PROMPT PAYMENTSee Schedule,

15C. QUANTITY

15D. UNIT

15E. UNIT PRICE

15F. AMOUNTSEE SCHEDULE

—,

(X) I

X
X

X

X
X
X

15G. TOTAL ANIO UNT OF CO NTRACT$480,916,636.62,
16. TABLE OF CONTENTSDESCRIPTIONI PAGE(S), (X) I SEC. I
DESCRIPTIONI PAGE(S)C. I
PART! - THE S C HEDUIEPART II - C 0 NTRIC T CLAUSESA SOLICITATION/ CONTRACT FORM
1
I I 'CONTRACT CLAUSESI
B _SUPPLIES OR SERVICES AND PRICES/ COSTS
2
3
PARTITE - LIST OF DO CUNIENTS, EXHIBITS AND OTHER ATTACH.
,,,C DESCRIPTION/ SPECS./ WORK STATEMENTI J ILIST OF ATTACHMENTSI, 4 - 37,
D PACKAGING AND MARKINGPARTIN - REP RES ENTA1I0 NS AND LNS IRUC110 NS
E INSPECTION AND ACCEPTANCE
38
REPRESENTATIONS. CERTIFICATIONS AND
K
F _DELIVERIES OR PERFORMANCEOTHER ST AT EMENT S OF OFFERORS.
, 39
G CONTRACT ADMINISTRATION DATA
L INSTRS. CONDS, AND NOTICES TO OFFERORS.
.
; 40
H SPECIAL CONTRACT REQUIREMENTS
M EVALUATION FACTORS FOR AWARDCONTRACTING OFFICER WILL COMPLETE ITEM 17 (SEALED-BID OR NEGOTIATED PROCUREMENT) OR IS (SEALED-BID PROCUREMENT) AS APPLICABLE[ I SEALED-BID AWARD (Contractor is not remere4 to sip this resinonent )17 [XI CONTRACTOR S NEGOTIATED AGREEMENT
Contractor is required to sign thisdocument and meant
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 obligation of the parties to thiscontract shall be subject to and governed by the following documents: (a) this awardkostract,(b) dm solicitation, if any, and (e) such provisions, representations, certifications, and specification,
as are attached or incorporated by reference herein(Attachments are listed herein)

18

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

20A. NAME OF CONTRACTING OFFICERybid rii &thrum...Number

including the addition or changes made by you which additions or changes are set forth in full above, is hereby accepted as
to the terns listed above and on any continuation sheets This award consummates the contract which consists of thefollowing documents: (a) the Govermnenfs solicitation and your bid, and (b) this award/contract No further contractual
document is necessary (Block 18 should be checled only when awarding a sealed-be! contract)

TEL:

19B. NAME OF CONTRACTOREMAIL:

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

20C. DATE SIGNED

13-Oct-2020
BY

BY(Signature ofperson authorted to sign)
AUTHORIZED FOR LOCAL REPRODUCTION
Previous edition is NOT usable(Signature of Confrsicting Officer)
STANDARD FORM 26 (REV 5/2011)
Prescribed by GSA - FAR (48 CFR) 53214(a)Section B - Supplies or Services and Prices

ITEM NO
0001

SUPPLIES/SERVICESQUANTITY

1

UNIT
Lot

UNIT PRICEAMOUNT

Industrial Expansion (FFP)FFPINDUSTRIAL EXPANSION IN ACCORDANCE WITH AWARD
SPECIFICATIONSFOB: Origin (Shipping Point)
PURCHASE REQUEST NUMBER: 0011560601
PSC CD: AN14

NET AMT
ACRN AA
CIN: GFEBS001156060100001

ITEM NO
0002

SUPPLIES/SERVICESQUANTITY
6,000,000

UNIT
Each

UNIT PRICE

Test Cartridges (FFP)FFPCOVID-19 TEST CARTRIDGES AS SPECIFIED IN AWARD NARRATIVE
FOB: Origin (Shipping Point)
PURCHASE REQUEST NUMBER: 0011560601
PSC CD: AN14

NET AMT

ACRN AA
CIN: GFEBS001156060100002

AMOUNTITEM NO
0003

QUANTITY
UNIT
UNIT PRICI
) (4)
Each
30,000
Monitoring Systems (FFP)FFPMONITORING SYSTEMS AS SPECIFIED IN AWARD NARRATIVE
FOB: Origin (Shipping Point)
PURCHASE REQUEST NUMBER: 0011560601
PSC CD: AN14SUPPLIES/SERVICESAMOIJN I

NET AMT
ACRN AA
CIN: GFEBS001156060100003

ITEM NO
0004

SUPPLIES/SERVICESQUANTITY
60,000UNIT
Each

UNIT PRICE

Swab Packs (FFP)FFP
SWAB PACKS AS SPECIFIED IN AWARD NARRATIVE
FOB: Origin (Shipping Point)
PURCHASE REQUEST NUMBER: 0011560601
PSC CD: AN14

NET AMT
ACRN AA
CIN: GFEBS001156060100004

AMOUNTSection C - Descriptions and Specifications
OTHER TRANSACTION AGREEMENTOTHER TRANSACTION AUTHORITY FOR PROTOTYPE
AGREEMENTBETWEENCue Health, Inc. (Awardee)
And
Army Contracting Command — Aberdeen Proving Ground - Research Triangle Park, NC DIVISION(Government)
800 Park Office Drive Research Triangle Park, NC 27529
Effective Date: October 13, 2020
Agreement No.: W911NF-21-9-0001
Total Amount of the Agreement: $480,916,636

Awardee
Signature

Government
Signature

Printed Name

Printed NameCEOAgreements OfficerTABLE OF CONTENTS
ARTICLE 1: BACKGROUND, DEFINITIONS AND SCOPE OF THE AGREEMENTARTICLE 2: TERM AND TERMINATIONARTICLE 3: PROJECT MANAGEMENT AND MODIFICATIONSARTICLE 4: MANAGEMENT OF THE PROJECTARTICLE 5: "PREP ACT" COVERAGE
ARTICLE 6: FINANCIAL MATTERS
ARTICLE 7: DISPUTESARTICLE 8: CONFIDENTIAL INFORMATIONARTICLE 9: INTELLECTUAL PROPERTY RIGHTSARTICLE 10: DATA RIGHTSARTICLE 11: REGULATORY RIGHTSARTICLE 12: FOREIGN ACCESS TO DATAARTICLE 13: SCIENTIFIC PUBLICATIONS AND PRESS RELEASESARTICLE 14: ENSURING SUFFICIENT SUPPLY OF THE PRODUCTARTICLE 15: INSPECTION AND ACCEPTANCE
ARTICLE 16: REPORTING REQUIREMENTS
ARTICLE 17: MISCELLANEOUS CLAUSESARTICLE 18: PROHIBITION ON THE USE OF CERTAIN TELECOMMUNICATIONS AND VIDEOSURVEILLANCE SERVICES OR EQUIPMENT
APPENDIX A: STATEMENT OF WORKAPPENDIX B: PROJECT SCHEDULE/MILESTONE PAYMENT SCHEDULE
APPENDIX C: KEY PERSONNELAPPENDIX D: GOVERNMENT PROPERTYOTHER TRANSACTION AUTHORITY FOR PROTOTYPE
AGREEMENTThis Other Transaction Authority for Prototype Agreement is entered into between the UnitedStates of America, hereinafter called the "Government", pursuant to and under U.S. Federal law
and Cue Health Inc., a small business and non-traditional defense contractor, hereinafter called
the "Awardee". The United States of America and Awardee are sometimes referred to herein
individually as a "Party" and collectively as the "Parties."
WHEREAS, the Awardee is eligible for an Other Transaction Authority for Prototype
Agreement in accordance with 10 USC § 2371b(d)(1)(A) as amended by the National Defense
Authorization Act for Fiscal Year 2018 as they are non-traditional defense contractor, attestingto "An entity that is not currently performing and has not performed, for at least the one-year
period preceding the solicitation of sources by the Department of Defense for the procurement
or transaction, any contract or subcontract for the Department of Defense that is subject to thefull coverage under the cost accounting standards prescribed pursuant to Section 1502 of title
41 and the regulations implementing such section";
WHEREAS, the DoD currently has authority under 10 U.S.C. § 2371b to award "othertransactions" (0Ts) in certain circumstances for prototype projects that are directly relevant toenhancing the mission effectiveness of military personnel and the supporting platforms, systems,
components, or materials proposed to be acquired or developed by the DoD, or to improve
platforms, systems, components, or materials in use by the Armed Forces;
WHEREAS, a prototype can generally be described as a physical or virtual model used toevaluate the technical or manufacturing feasibility or military utility of a particulartechnology or process, concept, end item, or system;
WHEREAS, this Agreement meets the criteria for a prototype project;
NOW THEREFORE, the Parties have agreed as follows:

ARTICLE 1: BACKGROUND, DEFINITIONS AND SCOPE OF THE AGREEMENT
A. Background
The Department of Health and Human Services through DoD requires the ability to procure reliable point of caretesting assays and devices in sufficient quantities to meet the demand to respond to the on-going COVID-19 Pandemic.
The unprecedented demand for rapid and accurate molecular diagnostic testing continues to exceed national testing
capacity. Awardee, through funding provided by HHS, has already developed and received Emergency Use
Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for a rapid, portable, point of care COVID19 test capable of detecting SARS-CoV-2, the virus that causes COVID-19. The ability to deploy substantial quantitiesof the Cue POC COVID-19 test will not only increase national test capacity, but significantly reduce the time to informpatients of their result. The Cue Health test is anticipated to be used primarily in particular settings of concern, such as
nursing homes, long term care facilities and schools. It will also be beneficial to the armed services and the US
population at large, at other locations where a laboratory capability is not readily accessible. The Cue COVID-19 Testconsists of: 1.) the Cue COVID-19 Test Cartridge pack which includes a single use test cartridge and a single use
Sample Wand (swab); 2.) The Cue Health Monitoring System (reader); The Cue COVID-19 External Control Swabs
Pack. Hereafter, the components of the test as necessary for a single use are collectively referred to as a "COVID-19
Test".
B.

Definitions

Agreement Invention: Any invention conceived or first actually reduced to practice in the performance of the Prototype
Project under this Agreement.

Agreements Officer or AO: Warranted contracting officer authorized to sign the final OTA for the Government.
Agreement's Officer's Representative or AOR: The individual designated by the Government to monitor all technicalaspects and assist in agreement administration of the Prototype Project. The AOR shall only assist in agreementadministration of the Prototype Project to the extent delegated such administration authority in writing in the AOR
delegation letter by the responsible Agreements Officer.
Background Invention: Background Invention means any Invention, or improvement to any Invention, other than an
Agreement Invention, that was conceived, designed, developed, produced, and/or reduced to practice prior toperformance of this Agreement, or outside the scope of work performed under this Agreement.
Cause: An event or issue that has been discovered that the Government believes may impact successful performance of
the OTA.
Date of Completion: The date on which all work is completed or the date on which the period of performance ends.
•
Deliverable(s): Any documentation (e.g. report, Executive Summary, Letter) given to the Government by theAwardee as described in the second column of Table 1 in Article I, Section C.7 under the heading "Deliverable."•

Effective Date: The date of execution of this Agreement by the Parties.

•

Field: COVID-19 Diagnostic testing.

•Government: The United States of America, as represented by The Department of Defense and the Department
of Health and Human Services.
•

Government Purpose Rights: As defined in DFARS 252.227-7013(a)(13).

•Invention: Any invention or discovery which is or may be patentable or otherwise protectable under Title 35of the United States Code.
•Know-How: Information, practical knowledge, techniques, and skill development by Awardee in theperformance of the Prototype Project and which is necessary for the Practical Application of an Agreement Invention
within the Field.
•

Limited Rights: As defined in DFARS 252.227-7013(a)(14).

•Party: Each of the Government and Awardee. (collectively, "Parties").

•
Practical Application: With respect to an Agreement Invention, to manufacture, in the case of a compositionof product; to practice, in the case of a process or method, or to operate, in the case of a machine or system; and, in eachcase, under such conditions so as to establish that the Agreement Invention is capable of being utilized.
•

Program: Prototype efforts being conducted by the Parties pursuant to this Agreement.

•

Prototype Project: Has the meaning given in Article 1.C.

•
Project Coordination Team or PCT: Agreements Officer, Agreements Officer's Representative, Subject
Matter Experts and Team Leader(s) acting in support of Operation Warp Speed and responsible for periodic and ad-hoc
reporting to Operation Warp Speed Leadership.
•
Property: Any tangible personal property other than property actually consumed during the execution of work
under this Agreement.
•
Under this Agreement: When used, for example but without limitation, in the definitions of Data, KnowHow, Property, and Agreement Inventions, means activities conducted pursuant to this Agreement that are Government
funded.

Scope of the Agreement
1. Prototype Project: The prototype project under this Agreement is the demonstration by Awardee of the rapid,
large scale supply and logistics capability to manufacture and deliver to the Government within 5 months of theeffective date of this Agreement 6 million Cue COVID-19 Assay Cartridges, 60,000 COVID-19 Control SwabPacks, and 30,000 Monitoring Systems by achieving a sustained average per day production rate of at least
100,000 EUA or 510(k) cleared Cue COVID-19 Assay Cartridges over the last 7 days of the 5 month delivery
period. The expansion of Awardee's manufacturing capability will likely entail several actions. The company
will increase their overall output of assay cartridges by installing additional high capacity automated lines.
Additionally the Awardee will upgrade their bio production capability to ensure enough reagent materials areavailable to meet end-state test cartridge manufacturing goals. In addition Awardee will perform activities
required to onshore Monitoring System manufacturing to be performed either in-house, with a US-based
contract manufacturing organization or both. The demonstrated manufacturing capability will be in compliancewith ISO 13485 standards as well as the Quality System Regulations at 21 CFR Part 820.
In order to ensure the successful and expeditious completion of this prototype project, Awardee agrees andrepresents that, commencing on the effective date of this Agreement, the Government will be the exclusive
purchaser of the entire production of Awardee's COVID-19 Test until the prototype project has beensuccessful' • corn leted This1 • .urc aser condition is waived under the followin: circumstances:T e prototype project wi e successrn y comp ete I W en war . ee as ac ev . a sustam -. average per . y
production rate of at least 100,000 EUA or 510(k) cleared COVID-19 Assay Cartridges over a 7 day period,and has delivered a total of 6 million Cue COV1D-19 Assay Cartridges, 30,000 monitoring systems, and 60,000
control swab packs.
2. Associated Production: It is the intention of the Parties to enter into a separate, but associated, sole-source
FAR-based contract for the continued production of COV1D-19 Tests. Subject to applicable law and regulation,
the Parties shall take all steps necessary to negotiate and enter into such a FAR-based contract in good faithwith the intent of promptly signing such FAR-based contract as soon as possible after this Agreement. Followon oroduction nursuant to 10 USC 2371b is not antici ated for this oroiect.

Additionally, Awardee
shall grant the Government the right to place such orders as Priority Orders (as defined below) for which
Government purchase orders will be prioritized by Awardee as if they were "rated orders" subject to 15 CFR §700.14, subject to the priority afforded to orders that are expressly identified as HRPAS or DPAS rated orders.
3. Manufacturing Equipment Purchased With Government Funds: In recognition of, and in consideration
for, the Government's significant funding for the development of Awardee's enhanced manufacturing capability,
the Awardee agrees to never re-locate outside of the United States or its Territories any of the Automated
Assembly Line equipment purchased with Government funds under this Agreement.
4.

Performance by Affiliates: The Government acknowledges and agrees that Awardee may perform its
obligations under this Agreement through one or more of its affiliates and/or subcontractors, provided thatAwardee will be responsible for the full and timely performance as and when due under, and observance of, all
the covenants, terms, conditions and agreements set forth in this Agreement by its affiliates and/or
subcontractors.
5. Audits: Until such time as all tests, Monitoring Systems and control packs have been delivered under thisAgreement, and in no event after expiration of the Period of Performance, audits under this Prototype Agreement
may include Government Quality Assurance audits — periodic, ad hoc or for cause — of Awardee's or subagreement holders' facilities included in the supply chain. The Government will provide notification of aperiodic or ad hoc audit at least fourteen (14) calendar days prior to the intended audit date and both parties will
work in good faith to accommodate the audit and determine scheduling. In all audits, the Government willcomply with the Person in Plant requirements set forth in Article 1.C.7.

6. Person in Plant: The Government may request to have a government representative in place at Awardee's
facility, with no fewer than fourteen (14) calendar days' advance notice of the desired date for that person to bein place. The name, role, scope and duration will be mutually agreed between the Parties in writing in advance.
The Government representative will adhere to the agreed scope and to the Awardee's policies, procedures andinstructions at all times. 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 Awardee plant.
If considered for cause, the Government may place representatives in place at Awardee's facility, with no fewer
than 5 (five) business days' advance notice of the desired date for the person(s) to be in place, subject toapplicable COVID protocols. The names, roles, scope, and duration will be provided to the Awardee in advance.
The Government representative will adhere to the Awardee's policies, procedures and instructions regarding
facility regulations at all times. 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 Awardee plant.
7. Deliverables: Deliverables under this Agreement are listed in Table 1.
Variances: Awardee shall promptly notify the Government of any anticipated shortage in quantity or deviationfrom any delivery date specified herein. The Government and the Awardee shall cooperate in good faith toadjust Table 1 to reflect reasonable variations in the delivery schedule, provided that the total scheduled
quantities are delivered and Awardee demonstrates a production capacity of 100,000 units per day within not
more than 180 days after award.
Table 1: Deliverables
Item

14* Days
After
Award

28*
Days

42*
Days

56*
Days

70*
Days

84*
Days

98*
Days

112''
Da s

126* Days

140* Days

154*
Days

COVID-19
Test
Cartridges
HealthMonitoring
Systems
COVID-19
External
Control
Swab Packs

8,000

10,00040,00060,000180,000

400,000

650,000

912,000

1,100,000

1.240,000

1,400,000

100

500

1,000

2.000

2,400

4,000

4,000

4,000

4,000

4.000

4,000

80

100

400

600

1800

4000

6500

9i20

11.00012,40014.000* Delivery dates and quantities subject to adjustment as provided herein.

Deliverable
Increase Industrial Base
Manufacturing Capability to100K Cue COVID-19 Test
cartridges per day

Monthly Progress Reports
Weekly Progress Meetings
Quarterly In Process Review
Final Report
Subcontractor Supply Chain
Plans
Manufacturing Plan
Distribution Plan
Quality Management Plan

Delivery Date
6 Million EUA or 510(k) cleared
COVID-19 Test Cartridges(per delivery schedule above)
30K Health Monitoring Systems(per delivery schedule above)
60K COVID-19 External Control
Swab Packs(per delivery schedule above)
10th of the month, every month during
PoP
Weekly, as agreed upon
Every 90 days
5 days after last scheduled delivery
5 days after award

Method for Acceptance
Periodic Inspection & Random
Sampling (DCMA and AOR)

Progress Meeting (AOR)
Progress Meeting (AOR)
Progress Report (AOR)
Progress Report (AOR)

15 days after award
15 days after award
15 days after award

Progress Report (AOR)
Progress Report (AOR)
Progress Report (AOR)

Progress Report (AOR)

Monthly Progress Reports. The Awardee shall submit monthly progress reports no later than the 10th of the month.
Awardee format acceptable. Electronic submission acceptable in MS Office or PDF format. Financial information shallbe MS Excel format. Monthly reports shall NOT be marked proprietary, and shall have Distribution Statement C (USGovernment and their contractors). Each monthly report shall, at a minimum, contain the following:• Summary of monthly progress for each of the Awardee's facilities/capabilities associated with this effort.
• Summary of progress towards established milestones for each facility/capability.
• Identification of any milestone that is slipping or missed, and discussion of path forward to bring milestone back toschedule, and impact on other milestones.
• Summary of risks, discussion of potential impacts and efforts to mitigate.
• Summary of overall schedule and changes from previous month.
• Status updates from Manufacturing plan
• Status updates from Distribution plan
• Report any customer complaints• Report any known deficiencies of the materials and/or products• Financial summary of Awardee deliveries month to date, invoices submitted, and Government
payments made.
To the extent trade secret or other proprietary information is relevant to a monthly report, an appropriately marked
supplement may be provided.
Manufacturing Plan. The Awardee shall provide a detailed plan of action (contractor format acceptable) to increase
cartridge-manufacturing capability to meet the government's delivery schedule (i.e. ramp up to 100K cartridges perday) and associated on-shoring component manufacturing within 15 days of contract award. The Awardee's plan ofaction shall at a minimum, include the following:a. Timeline, materials required and strategy to set up and begin V2.0 manufacturing lines to manufacture
the cartridges;
b. Timeline, materials required and strategy to upgrade the bioproduction capability to manufacture
sufficient cartridge reagents;c. Timeline, materials required and strategy to onshore manufacturing of reagents and cartridge
subcomponents;
d. Information on the US based manufacturing organization to replace existing organization;
e. Current GMP manufacturing status and plan to achieve GMP manufacturing, if not currently GMP;
f. Quality Assurance plan and Acceptance metrics;
g. Plan to comply with FDA EUA Letter of Authorization.
Quality Management Plan. Cue Health, Inc. will, in the level of detail and format that Cue Health, Inc. solely elects (provided
such format provides a reasonable and industry-standard level of detail), provide a quality management plan for manufacturing
efforts that conform to ISO 13485 standards as well as the Quality System Regulations at 21 CFR Part 820 which may include,
but is not limited to, the quality policy and objectives, management review, competencies and training, process document
control, feedback, evaluation, corrective action and preventive action, process improvement, measurement, and data analysis
processes. The framework is normally divided into infrastructure, senior management responsibility, resource management,
lifecycle management, and quality management system evaluation.
Distribution Plan. Cue Health, Inc. will, in the level of detail and format that Cue Health, Inc. solely elects (provided
such format provides a reasonable and industry-standard level of detail), provide a Distribution Plan within 15 days ofcontract award, which shall provide a detailed distribution plan for how all Test Cartridge Packs, Monitoring Systems
and External Control Swabs Packs will be shipped and delivered to required delivery locations within the United Statesand its Territories. The Awardee's distribution plan shall at a minimum, include the following:a. Current distribution processes;b. Timeline and strategy to increase distribution process and shipping to handle the increase in number and volume of
shipments.
Subcontractor Supply Chain Plans. Cue Health Inc. will provide plans from key US subcontractors (swabmanufacturer, fluid transfer automation, etc) describing how they plan to expand their production capacities in support

of the Awardee. Cue Health Inc. will describe the source of capital such subcontractors expect to be utilized toincrease their production rates.
Final Report. Final Report shall NOT be marked proprietary, and shall have Distribution Statement C.
Contractor format acceptable. Electronic submission acceptable in MS Office or PDF format. Financial information
shall be MS Excel format. Final report summarizing stated objectives and the progress that was achieved in meeting
those objectives; summary of risks incurred, impacts and mitigation; quantitative discussion of production throughput
improvements achieved; financial summary of project; schedule summary for project, comparing original schedule to
final schedule; lessons learned for future similar endeavors, and recommendations for path forward as applicable.

8.

Milestones: Payable milestones under this Agreement are listed in Table 2a and 2b.

Payable Milestones
Table 2a Industrial Expansion Milestones

Milestone#
1

Milestone Description

Due Date

Advance payment for upfront
Industrial Expansion costs

Upon award

Demonstration ofMilestone
Award

Total Funds

Table 2b COVID-19 Test Delivery Milestones*
14 Days Post Award
Item
COVID-19
Test
Cartridges
HealthMonitoring

Systems
COVID-19
External
Control
Swab Packs

Qty

Payment

28 DaysQty

42 Days

Payment

Qty

56 Days

Payment

Qty

70 Days

Payment

Qty

Qty

8000

10,00040,00060,000180,000

400,000

100

500

1000

2000

2400

4000

80

100

400

600

1800

4000

Itelli
COVID-19
Test
Cartridges
HealthMonitoring
Systems
COVID-19
External
Control
Swab
Packs

Qty

98 Days
Payment

112 Days
Qty

Payment

126 Days

Qty-'av "lent140 Days
Payment
Q—q_.—

154 Days

912,000

1,100,000

1,240,000

1,400,000

4000

4000

4000

4000

4000

6,500

0.120

11,00012.40014,0001

Term of this Agreement

The Term of this Agreement commences upon the Effective Date and extends through final payment.
This Agreement is anticipated to end 5 months after the Effective Date, subject to mutually agreed

Payment

CiY—_ Pa \ merit

650,000

ARTICLE 2: TERM AND TERMINATIONA.

84 Days

Payment(b)extensions pursuant to paragraph 2.D to facilitate the completion of the project(s). A transaction for a
prototype project is complete upon the written determination of the appropriate official for the matterin question that efforts conducted under a Prototype OT: (1) met the key technical goals of a project,or (2) accomplished a particularly favorable or unexpected result that justifies the completion of the
prototype.

•

B.

Rights of Termination•
In the event that Awardee notifies the Government that, as a result of emerging safety or efficacy data, nofurther efforts will be undertaken towards the development of the COVID-19 Test manufacturing and delivery, then,either Party may notify the other Party of its intent to terminate this Agreement, which termination shall be effective
thirty (30) days after the date of such notice.
•Awardee shall have no liability to repay the Government for milestone payments made prior to the notificationof termination, except as otherwise provided for under Article 14 or Termination for Cause below. With respect tomilestones which have not been completed, Awardee shall be entitled to payment based on a percentage of the work
performed toward said milestones, plus reasonable charges the Awardee can demonstrate to the satisfaction of theGovernment using its standard record keeping system, have resulted from the termination. By way of example, thesecosts may include, but are not necessarily limited to, costs associated with non-cancellable agreements with vendors to
obtain manufacturing capacity or supplies in the performance of this prototype project agreement. Awardee shall not be
required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does
not give the Government any right to audit Awardee's records. Awardee shall not be paid for any work performed which
reasonably could have been avoided.
•
From and after the effective date of any such termination, Awardee shall have no further obligation to deliver
any test cartridges, Monitoring Systems or external controls, and the Government shall have no further obligation toaccept any such deliverables.
•
The Government and the Awardee will negotiate in good faith a reasonable and timely adjustment of all
outstanding issues between the Parties as a result of termination, including disposition of materials acquired for researchuse. Failure of the Parties to agree to a reasonable adjustment will be resolved pursuant to Article 7, Disputes. In theevent of termination, the Parties shall negotiate in good faith a reasonable wind-down plan and neither Party shall haveany continuing obligations to perform under the Program except as otherwise specified herein.
Termination for Convenience: The Government may terminate this Agreement for any or no reason by providing atleast thirty (30) calendar days' prior written notice to the Awardee. The Government and Awardee will negotiate ingood faith a reasonable and timely adjustment of all outstanding issues between the Parties as a result of termination by
the Government for convenience, provided that Awardee shall retain all payments for work performed prior to theeffective date of the termination consistent with the terms of this Agreement, subject to the Government retaining theright to place Priority Orders for up to twelve (12) months after the date of such termination, as defined in Article 1,
Paragraph C., subparagraph 2., for other diagnostic tests manufactured using the manufacturing equipment purchasedwith Government funds under this Agreement.
Termination for Cause: If the Awardee materially fails to comply with the provisions of this Agreement, including
unjustifiably failing to maintain EUA or advance to 510(k) clearance for Awardee's COVID-19 Test, the Other
Transaction Agreement Officer (OTA0), after issuance of a cure notice and failure of the Awardee to cure the defectwithin ten (10) business days or the time allowed by the ()TAO after Awardee's receipt of the cure notice, whichever islonger, may take one or more of the following actions as appropriate:
(i)
(ii)
(iii)

temporarily withhold payments pending correction of the deficiency,
disallow all or part of the price attributable to the activity or action not in compliance,
wholly or partly suspend or terminate this Agreement,

(iv)
(v)

withhold further funding, ortake any other legally available remedies.

If this Agreement is terminated for Cause, Awardee will grant the Government a non-exclusive, paid up, perpetual
license to the Awardee and subawardee patents and documentation necessary for the purpose of developing thePrototype. The Awardee shall provide the Government or its designee with a non-exclusive, paid up, license to any
patent, copyright, technical data or regulatory information held by the Awardee that relates to the technology to permit
the Government to pursue commercialization of the technology with a third party, on terms to be agreed between theParties and subject to rights granted or held by third parties. The terms of this section and the obligations herein will be
included in any exclusive license given by the Awardee to a third party for any intellectual property covered by thisAgreement, on terms to be agreed between Awardee and such third party. This clause will survive the acquisition or
merger of the Awardee by or with a third party.
In addition to the Government's remedies prescribed in this Article 2.B, Termination for Cause, after the finalization ofa termination for default hereunder, where defaulted Awardee has exited or abandoned its business in the Field or has
unreasonably abandoned its efforts to maintain EUA or advance to 510(k) clearance for Awardee's COVID-19 Test,
the Government may upon 30 days written notice to Awardee, take possession of and title to all manufacturing
equipment purchased using Government funds provided under this Agreement.
C.

Survival

In the event of Termination, all rights, obligations, and duties hereunder, which by their nature or by their express
terms extend beyond the expiration or termination of this Agreement, including but not limited to warranties,
indemnifications, intellectual property (including rights to and protection of Intellectual Property and Proprietary
Information), and product support obligations shall survive the expiration or termination of this Agreement.
•

D.

Stop Work Orders•
Except as required by applicable law or regulation, or judicial or administrative order, the Government shall nothave the authority to issue a stop work order to halt the work contemplated under the Statement of Work.
E.
Extension of Term
The Parties may extend by mutual written agreement the Period of Performance if funding availability and research anddevelopment or prototype demonstration opportunities reasonably warrant.

ARTICLE 3: PROJECT MANAGEMENT AND MODIFICATIONSTechnical and project management of the prototype project and associated scope within the Statement of Work shall be
managed as detailed in this Article.
A.

Project Governance. Awardee is responsible for the overall management of the Prototype Project and related
decisions. The Government and Awardee are bound to each other by a duty of good faith in achieving thePrototype Project as defined in Article 1. As such, the Government will have continuous involvement withAwardee shall provide project results in accordance with the Deliverables schedule identified in Table 1.

B.

Project Management. Awardee and the Government will each designate an individual responsible forfacilitating the communications, reporting, and meetings between the Parties. For Awardee the individual willserve as PM, and for the Government the individual will be the AOR.

C.

Project Reviews. Awardee and the Government will hold periodic project review meetings as determined by
the Awardee Project Manager and AOR, however, these meetings shall not occur more frequently than every
fourteen (14) calendar days.

D.

Reviews Resulting in Modifications. During the performance of this Prototype Agreement, as describedabove, it may be necessary to modify the scope of the Prototype Project or delivery timeframes. No
communications, whether oral or in writing, that purport to change this Agreement are valid unless and until amodification is issued by the AO. The Parties hereby agree that any mutually agreed upon written request for
modification shall be executed in an expedited timeframe. Modifications to subawards and/or new subcontracts
under this Agreement that could reasonably impact the technical approach proposed and accepted by theGovernment require the approval of the AOR prior to being executed.

E.

Bilateral Modifications. Awardee or the Government may propose modifications to this Agreement. A
modification that materially changes the obligations of either the Government or Awardee must be in writing
and signed by the AO and Awardee authorized official. Awardee requests for modifications shall detail thetechnical, chronological and financial impact of the proposed change on the Statement of Work or delivery
timeframes.

F.

Unilateral Modifications. The AO may ONLY issue minor or administrative modifications, which do notchange the obligations of Awardee in any adverse manner, such as changes to the paying office or appropriations
data, or changes to Government personnel identified in the Agreement. Unilateral modifications will only besigned by the AO.

G.

The AO has assigned an Agreements Officer's Representative (AOR) for this agreement. The Awardee will
receive a copy of the written designation outlining the roles and responsibilities of the AOR and specifying theextent of the AOR's authority to act on behalf of the OTA. The AOR is not authorized to make any commitmentsor changes that will affect price, quality, quantity, delivery, or any other term or condition of the contract.

H.

Agreement Administration
In no event shall any understanding or agreement, modification, change order, or other matter in deviationfrom the terms of this Agreement between the Awardee and a person other than the AO be effective orbinding upon the Government. All such actions must be formalized by a proper contractual document
executed by the AO.
Government Points of Contact:
Agreements Officer (AO)
NAME:
MAILING ADDRESS: 800 Park Office Drive. Research Triangle Park (RTP). NC 27529
EMAIL:
PHONE
AGEN
SION/SECTION: Army Contracting Command — Aberdeen Proving Ground — RTP
Division
Agreements Officer Representative (AOR)
NAME:
MAILING ADDRESS:
EMAIL
PHONE

110 Thomas Johnson Drive, Suite 200, Frederick, MD 21702

Cue Health. Inc. Points of Contact:
Project Manager (PM)NAME:
MAILING ADDRESS:EMAIL:
PHONE:(will be provided within 30 calendar days after award)

ARTICLE 4: MANAGEMENT OF THE PROJECTA.

Document Review•
The Awardee shall provide the PCT sufficient opportunity to review study protocols, reports, and project plans.
PCT's comments on these documents will be viewed as advisory in nature.
B.

Sub-agreement Holders•

1.
The Government acknowledges that, in order to combat the global pandemic and provide the test
cartridges, Monitoring Systems and external controls as quickly as possible, Awardee has entered into a numberof contracts prior to the Execution Date, and the Government agrees that it will not require these contracts to berenegotiated. Therefore, except as otherwise expressly set forth in this Article 4.B, any provision requiring
Awardee to flow-down an obligation to its sub-agreement holders will apply only to sub-agreements executedby Awardee following the Execution Date of this Agreement.
•

2.
For clarity, as detailed within the Articles themselves, the following Articles require flow-down to subagreements/contracts executed after the Execution Date:(i) Article 8: Confidential Information.

••(ii) Article 13.E: Subawards where the sub-agreement holder may propose publishing the results of
its work under the subaward.
•(iii) The Awardee will flow-down the provisions of Article 19 (Prohibition on the Use of Certain
Telecommunications and Video Surveillance Services or Equipment) to all of its sub-agreements/contracts asprovided in Article 19.
•
ARTICLE 5: "PREP ACT" COVERAGE
In accordance with the Public Readiness and Emergency Preparedness Act ("PREP Act"), Pub. L. No. 109-148, Division
C, Section 2, as amended (codified at 42 U.S.C. § 247d-6d and 42 U.S.C. § 247d-6e), as well as the Secretary of Healthand Human Service's ("HHS") Declaration Under the Public Readiness and Emergency Preparedness Act for Medical
Countermeasures Against COVID-19, 85 Fed. Reg. 15198 (Mar. 17, 2020, effective Feb. 4, 2020), and amended on April
15, 2020, 85 Fed. Reg. 21012, and on June 8, 2020, 85 Fed. Reg. 34740 (together, the "Prep Act Declaration"):(i)This Agreement is being entered into for purposes of facilitating the manufacture, testing,development, distribution, administration, and use of "Covered Countermeasures" for responding to the COVID-19
public health emergency, in accordance with Section VI of the PREP Act Declaration;(ii)
Awardee performance of this Agreement falls within the scope of the "Recommended Activities" forresponding to the COVID-19 public health emergency in accordance with Section III of the PREP Act Declaration; and(iii)

Awardee is a "Covered Person" per Section V of the PREP Act Declaration.

Therefore, in accordance with Sections IV and VII of the PREP Act Declaration, as well as the PREP Act (42 U.S.C. §247d-6d), the Department of Defense contracting via assisted acquisition on behalf of the HHS, expressly acknowledges
and agrees that the HHS Declaration cited above, specifically its language providing immunity from suit and liability isapplicable to this Agreement, as long as Awardee activities fall within the terms and conditions of the PREP Act and the
PREP Act Declaration.
The Goverrunent may not use, or authorize the use of, any products or materials provided under this Agreement, unlesssuch use occurs in the United States (or a U.S. territory where U.S. law applies including, but not limited to, embassies,
military installations and NATO installations) and is protected from liability under a declaration issued under the PREP
Act, or a successor COVID-19 PREP Act Declaration of equal or greater scope. Any use where the application of the
PREP Act is in question will be discussed with Awardee prior to use and, if the Parties disagree on such use, the dispute
will be resolved according to Article 7, "Disputes."

ARTICLE 6: FINANCIAL MATTERS - OBLIGATION AND PAYMENTThis Agreement is fixed-price type Other Transaction Authority agreement. The payments provided under thisAgreement are intended to compensate the Awardee on a fixed price basis for performance under this Agreement.

A.

Obligation

Except as specified in Article 7: Disputes, the Government's liability to make payments to the Awardee is limited only
to those funds obligated under this Agreement or by modification to the Agreement. The ACC-APG Contracting Activity
may incrementally fund this Agreement. If modification becomes necessary in performance of this Agreement, pursuant

to Article 3 of this Agreement, the AO and the Awardee shall establish and execute a mutually agreed upon revised
Schedule of Payable Milestones consistent with the current SOW.
B.

Payments
1. With the exception of test cartridges, Monitoring Systems and external control packs delivered either to Vendormanaged Inventory and/or Government distribution sites for which Government acceptance is detailed in Article
16, Awardee will provide AOR and AO notification of milestone success and any documentation that supports
successful completion of the milestone. Within five (5) business days of receipt, the AO will either, 1) confirm
milestone completion and authorize the Awardee to invoice against the completed milestone or, 2) notify theAwardee of any deficiencies, additional documentation or clarifications reasonably needed by the Government
to complete its review of the milestone. The Parties agree that payments will be made upon the AOR's
acceptance of completed milestones. These payments reflect value received by the Government toward theaccomplishment of the Prototype Project goals.
Payments are based on amounts generated from the Awardee's financial or cost records. The Awardee shall bereimbursed for each element identified in the awarded cost proposal, executed and accomplished in accordancewith the performance schedule.
2. After accomplishment of each milestone, the Awardee will submit the corresponding invoice through aGovernment provided invoicing and payment system, as detailed in Article 18.
3. Except as set forth in Article 7, Disputes, in no case shall the Government's financial liability exceed the amountobligated under this Agreement.
4. Payments will be made by the cognizant Defense Finance and Accounting Services office, as indicated below,
in accordance with the Prompt Payment Act. Article 18 details how to submit and process invoices.
5. Payments shall be made in the amounts set forth in the SOW, provided the AOR has verified the completion of
the applicable milestones. The Government will pay Awardee in US dollars.
6. The amounts payable by the Government to the Awardee pursuant to this Agreement shall not be reduced on
account of any Taxes unless required by applicable law. The Awardee alone shall be responsible for paying any
and all Taxes (other than withholding Taxes required to be paid by the Government under applicable law) leviedon account of, or measured in whole or in part by reference to, any payments it receives. If the Awardee isentitled under any applicable Tax treaty to a reduction of rate of, or the elimination of, or recovery of, applicable
withholding Tax, it shall deliver to the Government or the appropriate governmental authority (with theassistance of the Government to the extent that this is reasonably required and is expressly requested in writing)the prescribed forms necessary to reduce the applicable rate of withholding or to relieve the Government of its
obligation to withhold Tax, and the Government shall apply the reduced rate of withholding, or dispense withthe withholding, as the case may be, to the extent it complies with the applicable Tax treaty. If, in accordancewith the foregoing, the Government withholds any amount, it shall make timely payment to the proper Taxing
Authority of the withheld amount, and send to the Awardee proof of such payment within 90 days followingthat payment.
As used herein: Taxes means all taxes of any kind, and all charges, fees, customs, levies, duties, imposts,
required deposits or other assessments, including all federal, state, local or foreign net income, capital gains,gross income, gross receipt, property, franchise, sales, use, excise, withholding, payroll, employment, social
security, worker's compensation, unemployment, occupation, capital stock, transfer, gains, windfall profits, net
worth, asset, transaction and other taxes, and any interest, penalties or additions to tax with respect thereto,
imposed upon any person by any Taxing Authority or other governmental authority under applicable law,whether disputed or not, and including any obligation to indemnify or otherwise assume or succeed to the Tax
liability of any other person by law, by contract or otherwise. Taxing Authority means any governmental
authority or any subdivision, agency, commission or authority thereof or any quasi-governmental body
exercising tax regulatory authority.
7. The Awardee shall maintain adequate records to account for all funding under this Agreement. Neither the Cost
Accounting Standards nor any other aspect of the Federal Acquisition Regulation or its supplements apply toAwardee's accounting of costs under this Agreement. Cost shall be accounted for in accordance with Awardee's
commercial accounting practices. Awardee has an established and agrees to maintain an established accounting

system which complies with Financial Reporting Standards and the requirements of this Agreement, and shallensure that appropriate arrangements have been made for receiving, distributing and accounting for Federal
funds. An acceptable accounting system is one in which all costs, cash receipts and disbursements for whichAwardee is entitled to reimbursement under Article 6 are controlled and documented properly.
A.
Obligation. Under no circumstances shall the Government's financial obligation exceed theamount obligated in this Agreement or by amendment to the Agreement. The amount of Government funds
obligated by this Agreement and available for Payment is set forth on page 1, Line of Accounting andAppropriation. The Government may incrementally fund this agreement.
B.
The Government is not obligated to provide payment to the Awardee for amounts in excess of
the amount of obligated funds allotted by the Government.
C.
The Government shall pay the Awardee, upon submission of proper invoices, the costs
stipulated in this Agreement for work delivered or rendered and accepted, less any deductions provided inthis Agreement. Unless otherwise specified, payment shall be made upon acceptance of any portion of thework delivered or rendered for which a price is separately stated in the Agreement. Payments will be madewithin thirty (30) calendar days of receipt of a request for payment.
D.
Prior written approval by the AO, or the AOR, is required for all travel directly andidentifiably funded by the Government under this agreement. The Awardee shall present to the AO or
AOR, an itinerary for each planned trip, showing the name of the traveler, purpose of the trip,
origin/destination, dates of travel, and estimated cost broken down by line item as far in advanced of the
proposed travel as possible, but no less than two weeks before travel is planned to commence. In the eventthat emergency travel is required (e.g. in the event of an outbreak) that would make two weeks' noticeimpractical, travel requests may be submitted to the Government for an expedited review. Emergency
travel requests shall be labelled as such and shall include a brief summary of the emergency situation andrationale for expedited review.
E.
(a)

WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (MAY 2013)
Definitions. As used in this clause--

Department of Defense Activity Address Code (DoDAAC) is a six position code that uniquely identifies aunit, activity, or organization.
Document type means the type of payment request or receiving report available for creation in Wide Area
WorkFlow (WAWF).
Local processing office (LPO) is the office responsible for payment certification when payment
certification is done external to the entitlement system.
Electronic invoicing. The WAWF system is the method to electronically process vendor payment(b)requests and receiving reports, as authorized by DFARS 252.232- 7003, Electronic Submission of Payment
requests and Receiving Reports.
WAWF access. To access WAWF, the Awardee shall (i) have a designated electronic business(c)point of contact in the System for Award Management at https://www.acquisition.gov; and (ii) be
registered to use WAWF at https://wawfleb mil/ following the step-by-step procedures for self-registration
available at this website.
WAWF training. The Awardee should follow the training instructions of the WAWF Web-Based(d)Training Course and use the Practice Training Site before submitting payment requests through WAWF.
Both can be accessed by selecting the "Web Based Training" link on the WAWF home page athttps://wawf.eb mil/.
(e)
WAWF methods of document submission. Document submissions may be via Web entry,
Electronic Data Interchange, or File Transfer Protocol.

WAWF payment instructions. The Awardee must use the following information when submitting
payment requests and receiving reports in WAWF for this Agreement:

(f)

(1)
Document type. The Awardee shall use the following document type:
Voucher(2)
Inspection/acceptance location. The Awardee shall select the following inspection/acceptancelocation(s) in WAWF. as specified by the contracting officer.
Document routing. The Awardee shall use the information in the Routing Data Table below only(3)
to fill in applicable fields in WAWF when creating payment requests and receiving reports in the system.
Routing Data Table
Field Name in WAWF

Data to be entered in WAWF

Pay Official DoDAAC

HQ0339Issue By DoDAAC

W911NF

Admin DoDAAC

S0514A

Inspect By DoDAAC

W56XNH(4)
Payment request and supporting documentation. The Awardee shall ensure a payment request
includes appropriate contract line item and sublime item descriptions of the work performed or supplies
delivered, costs, fee (if applicable), and all relevant back-up documentation In support of each payment
request.
WAWF email notifications. The Awardee shall enter the email address identified below in the "Send(5)
Additional Email Notifications" field of WAWF once a document is submitted in the system.

(g)

WAWF point of contact.

(1)
The Awardee may obtain clarification regarding invoicing inWAWF from the following contracting
activity's WAWF point of contact.
(2)
For technical WAWF help. contact the WAWF helpdesk at 866-618-5988.
(End of Clause)

1. The AOR identified in Supplement 4, "Agreement Administration" shall continue to formally inspect
and accept the deliverables/milestones. To the maximum extent practicable. the AOR shall review thedeliverable(s) milestone report(s) and either:i. provide a written notice of rejection to the Awardee which includes feedback regarding deficiencies
requiring correction orii. written notice of acceptance to the AO, and acceptance in the WAWF system.
2. Acceptance within the WAWF system shall be performed by the AOR.
Note for DFAS: The Agreement shall be entered into the DFAS system by CLIN - Milestone
association (MS)/ACRN as delineated in Section B of the Award. The Agreement is to be paid out by CLIN
(MS)/ACRN. Payments shall be made using the CLIN (MS)/ACRN association as delineated at Section B ofthis Award.

Awardee Information: As identified at Central Contractor Registration, i.e., Commercial andGovernment Entity (CAGE) Code, Dun & Bradstreet number (DUNS), and Tax Identification Number (TIN).
Payments shall be made in the amounts set forth in the SOW, provided the AOR has verified the completionof the milestones.

F.

Comptroller General Access to Records: To the extent that the total Government payments
under this Agreement exceed $5,000,000, the Comptroller General, at its discretion, shall have access toand the right to examine records of any Party to the Agreement or any entity that participates in theperformance of this Agreement that directly pertain to, and involve transactions relating to, the Agreement
for a period of three (3) years after final payment is made. This requirement shall not apply with respect toany Party to this Agreement or any entity that participates in the performance of the Agreement, or any
subordinate element of such Party or entity, that has not entered into any other agreement (contract, grant,cooperative agreement, or "other transaction") that provides for audit access by a government entity in theyear prior to the date of this Agreement. This paragraph only applies to any record that is created or
maintained in the ordinary course of business or pursuant to a provision of law. The terms of this paragraphshall be included in all sub-agreements to the Agreement other than sub-agreements with a component of
the U.S. Government. The Comptroller General may not examine records pursuant to a clause included inan agreement more than three years after the final payment is made by the United States under theagreement.

C.

Comptroller Access Financial Records and Reports:

Awardee shall maintain adequate records to account for Federal funds received under this Agreement and shall maintainadequate records to account for funding provided under this Agreement. Awardee relevant financial records are subject
to examination or audit by or on behalf of the Comptroller General, Contracting Activity AO, or other Government
Official for a period not to exceed three (3) years after expiration of the term of the Agreement. The Comptroller General,
AO or designee shall have direct access to sufficient records and information of any party to this agreement or any entitythat participates in the performance of this agreement to ensure full accountability for all funding under this Agreement.
Such audit, examination or access shall be performed during business hours on business days upon prior written noticeand shall be subject to the security requirements of the audited party. Any audit required during the course of the program
may be conducted by the Comptroller General or other Government Official using Government auditors or, at the requestof Awardee's external CPA accounting firm at the expense of the Awardee.
1.

Lower Tier Agreements

The Performer shall include this Article, suitably modified to identify the Parties, in all subcontracts or lower tieragreements entered into solely in connection with this Agreement.
ARTICLE 7: DISPUTESA.

GeneralThe Parties shall communicate with one another in good faith and in a timely, responsive, and cooperative manner whenraising issues under this Article.
B.

Dispute Resolution Procedures
1.

Any claim or dispute between the Government and Awardee concerning questions of fact or law arisingfrom or in connection with this Agreement, and, whether or not involving an alleged breach of thisAgreement, shall be raised and resolved under this Article.

2.

Whenever legal disputes or claims arise, the Parties shall attempt to resolve the issue(s) by discussion
and come to mutual agreement on a resolution as soon as practicable. In no event shall a dispute,disagreement or misunderstanding of which the aggrieved Party became aware more than six (6)months prior to the notification made under sub-section B.3 of this Article constitute the basis for relief
under this Article unless one level above the AO, in the interests of justice, waives this requirement.

C.

3.

Failing resolution by mutual agreement, the aggrieved Party shall document the dispute, disagreement,or misunderstanding by notifying the other Party (through the AO Awardee s POC, as the case maybe) in writing of the relevant facts, identifying unresolved issues, and specifying the clarification or
remedy sought. Within five (5) working days after providing notice to the other Party, the aggrieved
Party may, in writing, request a joint decision by the ACC-APG Division Chief for and senior executive
appointed by Awardee The other Party shall submit a written response on the matter(s) in disputewithin thirty (30) calendar days after being notified that a decision has been requested. The Division
Chief and the Awardee senior executive shall conduct a review of the matter(s) in dispute and attempt
to render a mutually agreeable decision in writing within thirty (30) calendar days of receipt of such
written position. Any such joint decision is final and binding.

4.

In the absence of a joint decision, upon written request to the ACC-APG Associate Director madewithin thirty (30) calendar days of the expiration of the time for a decision under sub-section B.3 above,the dispute shall be further reviewed. The Associate Director may elect to conduct this review
personally or through a designee or jointly with a senior executive appointed by Awardee Following
the review, the Associate Director or designee will resolve the issue(s) and notify the Parties in writing.
This decision may be appealed to any federal court of competent jurisdiction.

5.

Notwithstanding any other provisions of this Article, the Parties agree that Awardee shall have theright to pursue any contract dispute arising under this Agreement in any federal court of competentjurisdiction, including the appropriate Court of Appeals, or the Supreme Court, at any time without
any administrative exhaustion requirements, and the timing requirements described above will not limit
any claim in such tribunals.

Limitation of Damages

Claims for damages of any nature whatsoever pursued under this Agreement shall be limited to direct damages only up
to the aggregate amount of Government funding obligated as of the time the dispute arises, except with respect toviolations of Articles 5, 8, 9, or 10 of this Agreement.
ARTICLE 8: CONFIDENTIAL INFORMATION
A.
B.

C.

D.

E.

F.

"Confidential Information," as used in this Article, means information or data of a personal nature about anindividual, or proprietary information or data submitted by or pertaining to an institution or organization.
The Agreements Officer and the Awardee may, by mutual consent, identify elsewhere in this Agreement specificinformation and/or categories of information which the Government will furnish to the Awardee or that theAwardee is expected to generate which is confidential. Similarly, the Agreements Officer and the Awardee may,by mutual consent, identify such Confidential Information from time to time during the Period of Performance.
Failure to agree will be settled pursuant to the "Disputes" clause.
If it is established elsewhere in this Agreement that information to be utilized under this Agreement, or a portion
thereof, is subject to the Privacy Act, the Awardee will follow the rules and procedures of disclosure set forthin the Privacy Act of 1974, 5 U.S.C. § 552a, and implementing regulations and policies, with respect to systemsof records determined to be subject to the Privacy Act.
The Receiving Party shall not directly or indirectly, divulge or reveal to any person or entity any Confidential
Information of another Party without the Disclosing Party's prior written consent, or use such Confidential
Information except as permitted under this Agreement. Confidential Information shall be subject to the sameprohibitions on disclosure as provided for under FAR Part 24.202. Further, any reproduction of Confidential
Information or portions thereof that is disseminated within the Government, CMF, or Awardee, shall be sharedstrictly on a need to know basis for the purposes of this Agreement and is subject to the restrictions of thisprovision. In addition to the above, Confidential Information is subject to the protections of the Trade Secrets
Act as well as any other remedies available under this Agreement or the law.
Such obligation of confidentiality shall not apply to information which the Receiving Party can demonstrate
through competent evidence: (i) was at the time of disclosure in the public domain; (ii) has come into the publicdomain after disclosure through no breach of this contract; (iii) was known to the Receiving Party prior todisclosure thereof by the Disclosing Party; (iv) was lawfully disclosed to the Receiving Party by a Third Party
which was not under an obligation of confidence to the Disclosing Party with respect thereto; or (v) wasapproved for public release by prior written permission of the Disclosing Party.
Whenever the Awardee is uncertain with regard to the proper handling of material under the Agreement, or if
the material in question is subject to the Privacy Act or is Confidential Information subject to the provisions ofthis Article, the Awardee shall obtain a written determination from the Agreements Officer prior to any release,
disclosure, dissemination, or publication.
G.
Agreements Officer Determinations will reflect the result of internal coordination with appropriate program andlegal officials.
H.
The provisions of paragraph (D) of this Article shall not supersede conflicting or overlapping provisions
applicable Federal, State or local laws.
I.
The obligations of the Receiving Party under this Article shall continue for a period of seven (7) years fromconveyance of the Confidential Information.
Subject to Article 4.B, all above requirements MUST be passed to all Sub-awards.

ARTICLE 9: INTELLECTUAL PROPERTY RIGHTS
A.

Awardee represents that, to its knowledge, the intellectual property license(s) and other rights held by or granted
to Awardee, are sufficient to enable Awardee to perform its obligations under this Agreement.

B.

Background IP and Materials. Awardee and the Government each retain any intellectual property (IP) rights
to their own materials, technical data (as defined in 48 DFARS 252.227-7013), technology, information,
documents, or Know-How—or potential rights, such as issued patents, patent applications, invention
disclosures, copyrighted works, or other written documentation—that exist prior to execution of this Agreement
or are developed outside the scope of this Agreement ("Background IP"). For avoidance of confusion,
Background IP includes but is not limited to Background Inventions. Awardee agrees to provide, within 30
days of the effective date of this Agreement, a list of all Background Inventions relevant to Awardee's
performance of the prototype project. Any material defect identified in the Background Invention disclosurethat could materially negatively impact performance of the prototype project, will be addressed between the
AOR and the Awardee's designee.

C.

Government's Background IP. The Government has Background IP as constituted under contract number
HHS0100201800016C, including all executed modifications.

D.

Agreement Inventions. In the unlikely event that an invention is conceived or first actually reduced to practicein the performance of this Agreement ("Agreement Invention"), ownership of any Agreement Invention,
regardless of whether it is not patentable, or is patentable under U.S. patent law that is conceived or first reduced
to practice under this Agreement will follow inventorship in accordance with U.S. patent law. Neither theGovernment nor Awardee anticipate the conception or reduction to practice of any Agreement Invention. The
Government acknowledges that in the absence of any Agreement Invention, the Bayh-Dole Act (35 U.S.C. §§200-212) does not apply to, nor govern, this Agreement. Since, in the absence of any Agreement Invention, theBayh-Dole Act, does not apply to this Agreement, as such, title to Agreement Invention will accrue to theinventor or inventor-organization. In the absence of any Agreement Invention, the Government shall not have
any rights to "march-in," as that term is defined in 35 U.S.C. § 203, and Awardee is not subject to the
manufacturing requirements of 35 U.S.C. § 204.
In the event an Agreement Invention arises, the Parties represent and warrant that each inventor will assign his
or her rights in any such Agreement Inventions to his or her employing organization. If an Agreement Invention
is made either by a Awardee employee ("Sole Recipient Agreement Invention") or made by a Government
employee ("Sole Government Agreement Invention") the entire rights to that sole Awardee Agreement
Invention or Sole Government Agreement Invention will be respectively assigned to the Awardee or to theGovernment. If an Awardee employee and a Government employee jointly make an Agreement invention("Joint Agreement Invention"), it will be owned jointly by the Awardee and the Government. Ownership ofinventions made in whole or in part with sub-Awardee or collaborator employees, including employees of othercomponents of the Government, will be determined solely pursuant to an agreement between the Awardee andthe applicable sub-Awardee or collaborator. Notwithstanding the foregoing, neither the Government nor
Awardee anticipate the Government making a Sole Government Agreement Invention, nor the Parties jointly
making a Joint Agreement Invention, as Awardee employees are solely responsible, as between the Parties, forperforming the Prototype Project under this Agreement.

E.

Patent Applications. Each Party shall report any Agreement Inventions to the other Party within 60 days of thetime the inventor discloses it in writing to its personnel responsible for patent matters. The Parties will
respectively have the option, in their discretion, to file a patent application claiming any Agreement Invention
made solely by their respective employees (but, for clarity, are not obligated to file patent applications claiming

any Agreement Invention, and will not forfeit title by electing to hold an Agreement Invention as a trade secret).
The Parties will consult with each other regarding the options for filing a patent application claiming a joint
Agreement Invention. Within one (1) year of being notified of the discovery of an Agreement Invention, eachParty will provide notice of any filing of a patent application to the other Party. The Parties will reasonably
cooperate with each other in the preparation, filing, and prosecution of any patent application claiming a Joint
Agreement Invention. Any Party filing a patent application will bear expenses associated with filing andprosecuting the application, as well as maintaining any patents that issue from the application, unless otherwise
agreed by the Parties. Executive Order No. 9424 of 18 February 1944 requires all executive Departments andagencies of the Government to forward through appropriate channels to the Commissioner of Patents andTrademarks, for recording, all Government interests in patents or applications for patents.
F.

Patent Prosecution. Awardee agrees to take responsibility for the preparation, filing, prosecution, andmaintenance of any and all patents and patent applications that are relevant to the work performed under thisAgreement. Awardee shall keep the Government reasonably advised on the status of Awardee Background IP
by providing an annual report on the status of Awardee Background IP. With respect to a Sole Awardee
Agreement Invention or a Joint Agreement Invention, prior to acting on a decision by Awardee to abandon or
not file in any country a patent or patent application covering a Sole Awardee Agreement Invention or a Joint
Agreement Invention, Awardee shall so inform the Government in a timely manner to allow Awardee tothoughtfully consider the Government's comments regarding such a proposed decision.
If the Licensor shall continue the prosecution of any application for, to pay the maintenance fees on, or defend
in reexamination or opposition proceedings on, a Joint Agreement Invention on behalf of Awardee, Awardee
shall notify the Government within thirty (30) days. If the Licensor notifies Awardee that it declines to continue
prosecution of any application for, to pay the maintenance fees on, or defend in reexamination or opposition
proceedings on, a Joint Agreement Invention, Awardee shall notify the Government within thirty (30) days after
receipt of such notice.

G.

Patent Enforcement. Awardee will have the first option to enforce any patent rights covering a Joint Agreement
Invention at Awardee's expense. If Awardee chooses not to exercise this option, the Government may enforce
patent rights covering a Joint Agreement Invention.

H.

Licenses.
Background IP. The Government has the rights in Background IP constituted under contract number
HHS0100201800016C, including all executed modifications..
Agreement Inventions. Any Sole Awardee Agreement Invention is subject to a nonexclusive, nontransferable,
irrevocable, paid-up license for the Government, to practice and have practiced the Agreement Invention on
behalf of the Government. For any Sole Government Agreement Invention, upon the Awardee's request, theGovernment agrees to enter into good faith negotiations with the Awardee regarding the Awardee's receipt of anonexclusive commercialization license covering the Government's interest in any Sole Government
Agreement Invention.

ARTICLE 10: DATA RIGHTS
A.

Background Data. "Background Data" shall mean all data, that exists prior to execution of this Agreement, orare developed outside the scope of this Agreement. Awardee's Background Data includes, but is not limited to,the following technical data, to the extent such data exists prior to execution of this Agreement or is developed
outside the scope of this Agreement:
1. Technical data as defined at DFARS 252.227-7013 ("Technical Data"),
2. All data relating to the development, commercialization, manufacture of the test kits,
3. All data relating to the manufacturing, quality control testing (including in-process, release and stability
testing), processing, releasing, or packaging of the test kits; and4. Any and all data relating to preparatory work for distributing, importing, exporting, selling, offering for
sale, supplying, offering for supply or otherwise exploiting the Awardee COVID 19 tests.
All Background Data shall be owned by the Awardee, subject to the Government's rights in Background Datadeveloped or produced in the performance of contract number HHS0100201800016C, including all executed
modifications thereto. Awardee hereby grants the Government a non-exclusive license subject to the limitationsspecified in Article 10.0 to use any Background Data, other than clinical data, or financial, administrative, cost,pricing or management information, solely to the extent necessary for the Government to perform its obligations
under this Agreement and meet its objective of facilitating administration of the COVID-19 Tests delivered
under this Agreement in accordance with FDA and other applicable regulations.
B.

Subject Data. "Subject Data" is defined as all Technical Data generated by or on behalf of Awardee in theperformance of this Agreement. Subject Data shall be owned by the Awardee. The Government shall obtain"Unlimited rights", as this term is defined in DFARS 252.227-7013(a)(16) in Subject Data specified for delivery
under this Agreement and Government Purpose Rights, as the term is defined in DFARS 252.227-7013(a)(13),in Subject Data not specified for delivery under this Agreement. . The Awardee agrees to retain and maintainin a clear and readable manner, until seven (7) years after completion or termination of this Agreement, all
Subject Data.

C.

Restrictions on Government License Rights. Subject to the Government's pre-existing rights undercontract HHS0100201800016C as modified:a. Background Data other than computer software in which the Government has rights under Article
10.A shall be received by the Government subject to Limited Rights as defined at DFARS 252.2277013.
b. Background Data that is computer software in which the Government has rights under Article 10.A
shall be received by Government subject to Restricted Rights as defined at DFARS 252.227-7014,
except that the Government shall instead receive commercial software license rights in such softwarethat is a commercial item as defined at FAR 2.101.

D.

Marking of Data. The Awardee will mark any Data delivered under this Agreement with the following legend:"Use, duplication, or disclosure is subject to the restrictions as stated in Agreement No. W911NF-21-9-0001
between the Government and the Awardee."
The Awardee may further mark Data furnished with the rights specified in Article 10.0 as "Limited Rights
Data," "Restricted Rights Software," or "Commercial-Rights Software," as appropriate. Any rights that theAwardee or the Government may have in Data delivered under this Agreement, whether arising under thisAgreement or otherwise, will not be affected by Awardee's failure to mark Data pursuant to this Article.
All Subject Data, Technical Data and Software (each term as defined under DFARS 252.227- 7013) which shallbe delivered under this Agreement with less than Unlimited Rights shall be identified in reasonable specificity
and particular rights granted (Government Purpose, Limited or Restricted (all as defined in DFARS 252.2277013)). If the data is marked "Limited Rights", the Awardee shall provide, upon request by the Government, an
explanation to the Government as to why the data does not fall within the deliverables, and thus should not be
accorded Unlimited Rights status.

ARTICLE 11: REGULATORY RIGHTS
The Awardee shall provide the Government with all material communications and summaries thereof, bothformal and informal, to or from FDA, regarding the Awardee's EUA for its COVID-19 Test or the prototype
project within 48 hours, and make best efforts to ensure that the Government representatives are invited toparticipate in any formal or informal meetings with FDA. Awardee shall (1) ensure that the Government
representatives are consulted and are invited to participate in any formal or informal meetings with FDA related
to Awardee's COVID-19 Test and the prototype project; and (2) notify the FDA that the Government has theright to discuss with FDA any development efforts regarding the prototype project. In addition to the foregoing,Awardee shall use diligent efforts to notify the Government within 48 hours of any event, risk, formal orinformal FDA communication, or other issue that would be reasonably expected to materially impact theAwardee's EUA For the COIVD-19 Test or ability to advance to final 510(k) clearance of the Awardee's
COVID-19 Test.

ARTICLE 12: FOREIGN ACCESS TO DATAA.

The Parties will comply with any applicable U.S. export control statutes and regulations in performing thisAgreement.

ARTICLE 13: SCIENTIFIC PUBLICATIONS AND PRESS RELEASESA.

Neither Awardee nor the Government shall make, or permit any person to make, any public announcement
concerning the existence, subject matter or terms of this Agreement, the transactions contemplated by it, or the
relationship between the Awardee and the Government hereunder, without the prior written consent of the other,such consent not to be unreasonably withheld or delayed, except as required by law, any governmental or
regulatory authority (including, without limitation, any relevant securities exchange), any court or otherauthority of competent jurisdiction.

B.

Notwithstanding the foregoing, Awardee and (its upstream licensor) retains the right, but not the obligation, toprepare and submit scientific publications and release information to the public about its COVID-19
development program, without the Government's consent or involvement. The Awardee shall inform the AOR
when any abstract article or other publication is published, and furnish a copy of it as finally published.

C.

Unless authorized in writing by the AO, the Awardee shall not display Government logos including Operating
Division or Staff Division logos on any publications.

D.

The Awardee shall not reference the products(s) or services(s) awarded under this contract in commercial
advertising, as defined in FAR 31.205-1, in any manner which states or implies Government approval orendorsement of the product(s) or service(s) provided.

E.

Subject to Article 4.B, the Awardee shall include this clause, including this section (d) in all subawards where
the sub-agreement holder may propose publishing the results of its work under the subaward. The Awardee
shall acknowledge the support of the Government whenever publicizing the work under this Agreement in any
written media by including an acknowledgement substantially as follows:"This project has been funded in whole or in part by the U.S. Government under Agreement No. W911NF-219-00XX. The US Government is authorized to reproduce and distribute reprints for Governmental purposes
notwithstanding any copyright notation thereon."

ARTICLE 14: ENSURING SUFFICIENT SUPPLY OF THE PRODUCTA.

In recognition of the Government's significant funding for the development and manufacturing of the COVID19 Test and the Government's need to provide sufficient quantities of a COVID-19 tests to protect the UnitedStates population, the Government shall have the remedy described in this section to ensure sufficient supplyof test kits to meet the needs of the public health or national security. This remedy is not available to theGovernment unless and until any of the following conditions is met, and is not available as a result of atermination under Article 2(B) of this Agreement:
i.

ii.

B.

Awardee gives notice, required to be submitted to the Government no later than 30 business days,
following any formal management decision to terminate the product development effort, including adecision not to maintain EUA or proceed to 510(k) clearance during the term of this Agreement or three(3) years thereafter;Awardee gives written notice, required to be submitted to the Government no later than 15 business days,of any filing that anticipates Federal bankruptcy protection during the term of this Agreement or three(3) years thereafter.

If one or more of the conditions listed in Section 14.A occurs, Awardee, upon the request of the Government,
subject to the terms of the pre-existing agreement with Licensor, shall provide the following items necessary
for the Government to pursue licensure/authorization and manufacturing of the Technology with a third party
for exclusive sale to the U.S. Government:i.

ii.

a writing evidencing a non-exclusive, nontransferable, irrevocable (except for cause), royalty-free
paid-up license to practice or have practiced for or on behalf of the U.S. Government any Awardee
Background IP and Background Data, as those terms are defined in of this Agreement, necessary
to manufacture or have manufactured the Technology;
any outstanding Deliverables contemplated or materials and possession of and title tomanufacturing equipment purchased with Government funds under this Agreement.

C.

This Article will survive the acquisition or merger of the Awardee by or with a third party. This Article willsurvive the expiration of this agreement.

ARTICLE 15: INSPECTION AND ACCEPTANCE
A.

Delivery and Acceptance. Awardee shall notify the AO and AOR at least 7 calendar days prior to initialdelivery of first shipment of test kits. Exceptions are permitted if approved by the AO. Upon notification, theAOR will instruct the Awardee to deliver kits to either up to three centralized Government-designateddistribution sites within the continental United States or up to three additional specific individual finaldestinations within the continental United States. Upon delivery of product, notification of delivery quantities
shall be made to the AOR.
Upon receipt of the provided certificates and any inspection of product at the origin or destination site(s) thatwas timely requested (physical or representative, i.e., pictures), the AOR will review and recommend
acceptance or rejection. The Government shall accept product that conforms to contract requirements based on
Certificates of Analysis and certificate(s) of cGMP conformity provided by Awardee and review of temperaturemonitoring data. The AO will correspondingly notify Awardee of acceptance or rejection. However, theGovernment's acceptance of product will be deemed to have occurred if the Government does not provide
written notice of acceptance or rejection within fourteen (14) calendar days of Awardee's provision of all
applicable certificates.
A. Inspection: The Government has the right to inspect and test all work called for bythis Agreement, to the extent practicable at all places and times, including the period of
performance, and in any event before acceptance. The Government may also inspect thepremises of the Awardee. The Government shall perform inspections and tests in amanner that will not unduly delay the work. If the Government performs any inspection
or test on the premises of the Awardee, the Awardee shall furnish, at no increase in
price, all reasonable facilities and assistance for the safe and convenient performance of
these duties. Except as otherwise provided in the Agreement, the Government shall bear
the expense of Government inspections or tests made at other than the Awardee's
premises.
B. The Government shall inspect/accept or reject the work as promptly as practicable
after completion/delivery, unless otherwise specified in the Agreement. Government
failure to inspect and accept or reject the work shall not relieve the Awardee from
responsibility, nor impose liability on the Government, for nonconforming work.
Work is nonconforming when it is defective in material or workmanship or isotherwise not in conformity with Agreement requirements. The Government has theright to reject nonconforming work. Inspection/Acceptance of the Prototype
performed should not exceed 90 days after completion.

B.

Vendor-managed Inventory. Product to be stored as VMI will be shipped to Awardee's own warehouse
locations or its third party vendor's site, and may be stored for a period not longer than five (5) months. Prior
to expiration of this five (5) month period, the Government must either (a) provide Awardee with disposition
instructions in sufficient time to transfer and take possession of physical material from Awardee, (b) bilaterally
modify this agreement to extend the period of vendor management of storage, or (c) bilaterally modify thisAgreement to include destruction of remaining doses.
When held in VMI, these materials will be maintained in Awardee's or its designated representative's quality
and inventory systems. Product held in VMI is subject to the following requirements:
i.
ii.

iii.

Provide temperature controlled storage at the manufacturer's site approved by the Government,
according to cGMP and product specifications.
Where possible, store Project Agreement products physically segregated from other products. If
physical separation is not possible, separation of Project Agreement products must be controlled by alogical warehouse management system (WMS) at the case and pallet level.
Ensure proper labeling of stored materials as USG property.

iv.
v.
vi.

Provide the Government access to review the security systems in place and request updates as neededin accordance with the Security Plan.
Make appropriate updates to the regulatory documentation supporting the continued use of the stored
material for pandemic response.
If using a storage site, provide the quality agreement, specify the location and terms of the storage
contract and receive approval by the Government.

For accepted product in VMI, Awardee must notify the AOR of any proposed movement of the product. Any
deviations, out of specification ("00S") results, or other product issues, shall be reported to the USG within 3
calendar days of Awardee identification.
C.

Government Sites. Product to be shipped to Government Sites shall be shipped trackable by GPS. Awardee
will include the following information on the packing lists provided with bulk shipments to the centralized
depots:
i.
ii.
iii.

D.

Transaction Information (TI)
Transaction History (TH)Transaction Statement (TS)

Title and Physical Risk of Loss. Risk of loss or damage to the supplies provided under this contract shallremain with the Contractor until, and shall pass to the Government upon delivery of the supplies to theGovernment at the destination specified in the contract, i.e., F.O.B. Destination.
Awardee will notify the AO and AOR of any storage or quality deviation for product held in VMI, within 3
calendar days. To the extent that Awardee is responsible for the correction, repair or replacement ofGovernment property held in VMI and replacement upon loss or damage is feasible, the Government will accept
replacement of such property. The Government understands that storage costs identified in this contract include
insurance costs applicable to material that will become Government property, including product stored as VMI.
The AO and/or the AOR may perform inspection of materials and services. Inspections of material createdunder this Project Agreement may be made by a duly authorized Government representative, and withreasonable notice.

E.

Risk of Loss Due to Expiry. Both parties acknowledge that risk of loss due to expiry is retained by theGovernment for all product accepted under this Agreement. In order to mitigate this risk, the Awardee will
make kits available for delivery to VMI or Government distribution sites within 45 days of the date of
manufacture. Provided this condition is met, the Awardee will have no obligation to replace product that has
been accepted by the Government and expires prior to use.

ARTICLE 16: REPORTING REQUIREMENTS
The Government will have continuous involvement with Awardee throughout the duration of the Period of Performanceand is entitled to periodic reports as outlined below. Required components and frequency of such reporting is as follows:A.

Weekly Progress Meetings: Scheduled on a weekly basis, virtual format (either telephone or videoconference),
between the Contractor and the Government. Duration: 2 hrs max. Review of previous weeks activities.
Informative in nature to keep the USG apprised of project progress and to discuss issues that may require joint
resolution, such as milestone changes, political impacts on objectives, schedule, funding and deliverables.
On a quarterly basis, at the request of the AOR, the Weekly Teleconference may be expanded in scope to allow
for a progress review of the preceding three months and planning for the remainder of the period of performance.

B.

Daily and Ad hoc check-in, as requested by the PCT: A program specific designee of the Awardee will holda daily check-in with the AOR or AOR designee to discuss the performance of the Agreement. No agenda,
presentation, or official minutes need to be maintained for the regular meeting. The AOR may cancel the daily
check-in or substitute a technical or program specific meeting as a replacement. Daily check-ins are expected
only on business days during normal business hours.

C.

Confirmed, critical programmatic concerns, issues or probable risks that are likely to impact projectschedule/cost/performance: The Awardee will communicate and document all confirmed programmatic risks
to the AOR within 48 hours of Awardee's awareness. Awardee shall communicate via email or telephone.
Following resolution, Awardee will provide all associated deviation reports and corrective and preventative
action plans to the AOR within 48 hours of finalization.
In addition, the Awardee will report to the government any activity or incident that is in violation of establishedsecurity standards or indicates the loss or theft of government products within 24 hours of Awardee's awarenessof the activity or incident. Awardee will communicate via email, oral or written communication.

D.

E.

Supply chain resiliency, including Awardee locations: Within thirty (30) calendar days of award, theAwardee will provide the AOR with a supply chain resiliency plan. For each of the Awardee locations —including sub-agreement holders, the Awardee will provide address, point(s) of contact and a summary of work
performed at the location.
Quarterly Financial Status Report:
The Awardee shall submit a Quarterly Financial Status Report no later than twenty (20)calendar days after the end of each quarter of performance. The Government will haveten (10) calendar days to respond to the report with any comments and theAwardee will have an additional ten (10) calendar days to revise the deliverable or
respond to those comments. Reports will cover work performed every three (3)months for the duration of the Period of Performance (PoP).
For the industrial expansion effort, the Quarterly Financial Status Report shall
include quarterly expenditure forecasts with both the quarterly planned accrualand the cumulative total. Expenditure forecast submissions shall include analysisof the cost drivers for Estimate to Complete changes, if any, from the previous
projection. The Awardee shall provide all submissions in Excel format, including
all formulas.

ARTICLE 17. Miscellaneous Clauses.
A. No Consent. Nothing in the terms of this Agreement constitutes express or
implied Government authorization and consent for Awardee or its subawardee(s)to utilize, manufacture or practice inventions covered by United States orforeign patents in the performance of work under this Agreement.
B. Patent Infringement. Each Party will advise the other Party promptly and inreasonable written detail, of each claim or lawsuit of patent infringement basedon the performance of this Agreement. When requested by either Party, allevidence and information in possession of the Party pertaining to such claim or
lawsuit will be provided to the other at no cost to the requesting Party.
C. Limitation of Liability. In no event will either Party be liable to the other Partyor any third party claiming through such Party for any indirect, incidental,
consequential or punitive damages, or claims for lost profits, arising under or
relating to this Agreement, whether based in contract, tort or otherwise, even if theother Party has been advised of the possibility of such damages.
D. Disclosure of Information. Subject to Article 10, the Awardee shall not releaseto anyone outside the Awardee's organization any unclassified information,
regardless of medium (e.g., film, tape, document), pertaining to any part of thisAgreement or any program related to this Agreement, unless (i) the °TAO has
given prior written approval or (ii) the information is otherwise in the publicdomain before the date of release. For purposes of this clause, Awardee's
Organization includes entities identified as Collaborators in

E. Force Majeure. Neither Party will be liable to the other Party for failure ordelay in performing its obligations hereunder if such failure or delay arises fromcircumstances beyond the control and without the fault or negligence of the Party(a Force Majeure event). Examples of such circumstances are: authorized acts ofthe government in either its sovereign or contractual capacity, war, insurrection,
freight embargos, fire, flood, or strikes. The Party asserting Force Majeure as an
excuse must take reasonable steps to minimize delay or damages caused byunforeseeable events.
F. Severability. If any provision of this Agreement, or the application of any suchprovision to any person or set of circumstances, is determined to be invalid,
unlawful, void or unenforceable to any extent, the remainder of this Agreement,
and the application of such provision to persons or circumstances other than thoseas to which it is determined to be invalid, unlawful, void or unenforceable, will not
be impaired or otherwise affected and will continue to be valid and enforceable tothe fullest extent permitted by law.
G. Choice of Law. This Agreement and the resolution of disputes hereunder will
be governed, construed, and interpreted by the statutes, regulations, and/or legal
precedent applicable to the Government of the United States of America. Unlessexplicitly stated, the Parties do not intend that this Agreement be subject to theFederal Acquisition Regulation either directly or indirectly or by operation of law.
When a specific FAR requirement is incorporated by reference in this Agreement,
the text of the clause alone will apply without application or incorporation ofother provisions of these regulations.
H. Order of Precedence. In the event of a conflict between the terms of this Agreement
and the attachments incorporated herein, the conflict shall be resolved by giving
precedence in descending order as follows: (i) the Articles of this Agreement, and the
Appendices to the Agreement.

ARTICLE 18: PROHIBITION ON THE USE OF CERTAIN TELECOMMUNICATIONS AND VIDEOSURVEILLANCE SERVICES OR EQUIPMENTa) Definitions. As used in this clause—

Backhaul means intermediate links between the core network, or backbone network, and the small subnetworks
at the edge of the network (e.g., connecting cell phones/towers to the core telephone network). Bacichaul can be
wireless (e.g., microwave) or wired (e.g., fiber optic, coaxial cable, Ethernet).
Covered foreign country means The People's Republic of China.
Covered telecommunications equipment or services means—(1) Telecommunications equipment produced by Huawei Technologies Company or ZTE Corporation (orany subsidiary or affiliate of such entities);(2) For the purpose of public safety, security of Government facilities, physical security surveillance of
critical infrastructure, and other national security purposes, video surveillance and telecommunications
equipment produced by Hytera Communications Corporation, Hangzhou Hikvision Digital
Technology Company, or Dahua Technology Company (or any subsidiary or affiliate of such entities);(3) Telecommunications or video surveillance services provided by such entities or using such equipment;or(4) Telecommunications or video surveillance equipment or services produced or provided by an entitythat the Secretary of Defense, in consultation with the Director of National Intelligence or the Directorof the Federal Bureau of Investigation, reasonably believes to be an entity owned or controlled by, orotherwise connected to, the government of a covered foreign country.
Critical technology means—(1) Defense articles or defense services included on the United States Munitions List set forth in theInternational Traffic in Arms Regulations under subchapter M of chapter I of title 22, Code of Federal
Regulations;(2) Items included on the Commerce Control List set forth in Supplement No. 1 to part 774 of the Export
Administration Regulations under subchapter C of chapter VII of title 15, Code of Federal Regulations,and controlled(i) Pursuant to multilateral regimes, including for reasons relating to national security, chemical andbiological weapons proliferation, nuclear nonproliferation, or missile technology; or(ii) For reasons relating to regional stability or surreptitious listening;(3) Specially designed and prepared nuclear equipment, parts and components, materials, software, andtechnology covered by part 810 of title 10, Code of Federal Regulations (relating to assistance toforeign atomic energy activities);(4) Nuclear facilities, equipment, and material covered by part 110 of title 10, Code of Federal Regulations(relating to export and import of nuclear equipment and material);(5) Select agents and toxins covered by part 331 of title 7, Code of Federal Regulations, part 121 of title 9of such Code, or part 73 of title 42 of such Code; or(6) Emerging and foundational technologies controlled pursuant to section 1758 of the Export Control
Reform Act of 2018 (50 U.S.C. 4817).

Interconnection arrangements means arrangements governing the physical connection of two or more networks
to allow the use of another's network to hand off traffic where it is ultimately delivered (e.g., connection of acustomer of telephone provider A to a customer of telephone company B) or sharing data and other information
resources.
Reasonable inquiry means an inquiry designed to uncover any information in the entity's possession about theidentity of the producer or provider of covered telecommunications equipment or services used by the entity that
excludes the need to include an internal or third-party audit.
Roaming means cellular communications services (e.g., voice, video, data) received from a visited network
when unable to connect to the facilities of the home network either because signal coverage is too weak or
because traffic is too high.
Substantial or essential component means any component necessary for the proper function or performance ofa piece of equipment, system, or service.
(b) Prohibition.
(1) Section 889(a)(1)(A) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L.
115-232) prohibits the head of an executive agency on or after August 13, 2019, from procuring or obtaining, or
extending or renewing a contract to procure or obtain, any equipment, system, or service that uses covered
telecommunications equipment or services as a substantial or essential component of any system, or as criticaltechnology as part of any system. The Contractor is prohibited from providing to the Government any equipment,
system, or service that uses covered telecommunications equipment or services as a substantial or essential

component of any system, or as critical technology as part of any system, unless an exception at paragraph (c) of
this clause applies or the covered telecommunication equipment or services are covered by a waiver described in
FAR 4.2104.
(2) Section 889(a)(1)(B) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L.
115-232) prohibits the head of an executive agency on or after August 13, 2020, from entering into a contract oragreement, or extending or renewing a contract or agreement, with an entity that uses any equipment, system, orservice that uses covered telecommunications equipment or services as a substantial or essential component of any
system, or as critical technology as part of any system, unless an exception at paragraph (c) of this clause applies orthe covered telecommunication equipment or services are covered by a waiver described in FAR 4.2104. This
prohibition applies to the use of covered telecommunications equipment or services, regardless of whether that use
is in performance of work under a Federal contract or agreement.
(c) Exceptions. This clause does not prohibit contractors from providing—(1) A service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection
arrangements; or(2) Telecommunications equipment that cannot route or redirect user data traffic or permit visibility into any user
data or packets that such equipment transmits or otherwise handles.

(d) Reporting requirement(1) In the event the Contractor identifies covered telecommunications equipment or services used as a substantial or
essential component of any system, or as critical technology as part of any system, during contract or agreement
performance, or the Contractor is notified of such by a subcontractor at any tier or by any other source, the Contractor
shall report the information in paragraph (d)(2) of this clause to the Agreements Officer, unless elsewhere in thiscontract or agreement are established procedures for reporting the information; in the case of the Department of
Defense, the Contractor shall report to the website at https://dibnet.dod mil.
(2) The Contractor shall report the following information pursuant to paragraph (d)(1) of this clause(i) Within one business day from the date of such identification or notification: the contract number; the ordernumber(s), if applicable; supplier name; supplier unique entity identifier (if known); supplier Commercial andGovernment Entity (CAGE) code (if known); brand; model number (original equipment manufacturer number,manufacturer part number, or wholesaler number); item description; and any readily available information
about mitigation actions undertaken or recommended.
(ii) Within 10 business days of submitting the information in paragraph (d)(2)(i) of this clause: any further
available information about mitigation actions undertaken or recommended. In addition, the Contractor shalldescribe the efforts it undertook to prevent use or submission of covered telecommunications equipment orservices, and any additional efforts that will be incorporated to prevent future use or submission of covered
telecommunications equipment or services.
(e) Subcontracts. The Contractor shall insert the substance of this clause, including this paragraph (e) and excluding
paragraph (b)(2), in all subcontracts, subagreements and other contractual instruments, including subcontracts for theacquisition of commercial items.

Appendix A Statement of Work
Statement of Work (SOW): Point-of-Care (POC) Tests and Diagnostics
C.1. General Objectives.
The U.S. Government (USG) requires additional POC diagnostic test capacity, as the level of demand for diagnostic
resources during this COVID-19 Pandemic is unprecedented. There is a need to secure additional POC diagnostics
to test the US population in response to the Pandemic. The Government seeks to expand the production capacity for
Monitoring Systems and COVID-19 Test Cartridges. The end deliverable of this effort is to provide the capacity to
manufacture 100,000 cartridges per day.
As part of this effort, there shall result in an increase to its industrial base manufacturing capability for COVID-19
Test Cartridges within the U.S., to include critical supply chain providers to 100,000 cartridges per day. The
Awardee shall also onshore its cartridge and reader subcomponents manufacturing to the maximum extent possible,
to further reduce supply chain risk. The Awardee shall also develop a distribution process and increase shipping
capability in order to ship all materials directly to the customer location.
C.2. Prototype Delivery.
C.2.2. The Awardee shall increase its industrial base manufacturing capability to manufacture 100,000 cartridges perday.
C.2.2.1. The Awardee shall increase the manufacturing capability for the COVID-19 Test Cartridges to
100,000 cartridges per day.
C.2.2.2. The Awardee shall onshore its cartridge and reader subcomponents manufacturing.
C.2.2.3. The Awardee shall develop and expand its distribution process in order to ship all materials
directly to the customer location within the United States and its Territories.
C.3. Demonstration of Prototype Delivery.
C.3.1. The Awardee shall deliver 6 million COVID-19 Test Cartridge Packs.
C.3.2. The Awardee shall deliver 30,000 Health Monitoring Systems.
C.3.3. The Awardee shall deliver 60,000 COVID-19 External Control Swabs Packs.
C.3.4. The Awardee shall ship all deliverables to locations (TBD) within the United States.
C.3.5. The Awardee shall ensure appropriate quality assurance certification is supplied with each shipment.
C.4. Overall Management Objectives.
C.4.1. The Awardee shall be responsible for overall management and oversight of the work necessary to achieve theobjectives of this contract. The Contractor shall provide the overall management, integration, and coordination of allcontractual activities, including a technical and administrative infrastructure to ensure the efficient planning,
initiation, implementation, and direction of all contractual activities.
The Contractor shall establish project milestones for each manufacturing capability/capacity for which expansion isplanned. The Awardee shall provide incremental progress against each milestone to the USG in accordance withestablished deliverables (see C.6 below). The Awardee shall report to the USG any changes or deviations planned
or incurred by the Contractor in pursuing the objectives of this contract. While primary responsibility for
management and execution of the effort resides with the Awardee, the USG shall have input to the milestone review
process and any changes to the objectives of the agreement.

C.5.

Risk Management Objectives.

The Awardee shall identify all anticipated project risks categorized as moderate or high and report them to the USG in accordancewith reporting requirements (see C.6 below). The Awardee shall manage all project risks using its in- house risk management
capabilities, and report to the USG changes to all identified risks as they occur/arise. The USG shall be permitted to participate in
the risk management and mitigation processes associated with this project.
C.6.

Status Reporting.

C.6.1. Monthly Progress Reports. The Awardee shall submit monthly progress reports no later than the 101h of the month. Awardee
format acceptable. Electronic submission acceptable in MS Office or PDF format. Financial information shall be MS Excel format.
Monthly reports shall NOT be marked proprietary, and shall have Distribution Statement C (US Government and their contractors).
Each monthly report shall, at a minimum, contain the following:• Summary of monthly progress for each of the Awardee's facilities/capabilities associated with this effort.
• Summary of progress towards established milestones for each facility/capability.
• Identification of any milestone that is slipping or missed, and discussion of path forward to bring milestone back to schedule, andimpact on other milestones.
• Summary of risks, discussion of potential impacts and efforts to mitigate.
• Summary of overall schedule and changes from previous month.
• Status updates from Manufacturing plan
• Status updates from Distribution plan
• Report any customer complaints• Report any known deficiencies of the materials and/or products• Financial summary of Awardee costs incurred by month to date, invoices submitted, and Government payments made.
C.6.2. Weekly Progress Meetings. Scheduled on a weekly basis, virtual format (either telephone or videoconference), between theContractor and the Government. Duration: 2 hrs max. Review of previous weeks activities. Informative in nature to keep the USG
apprised of project progress and to discuss issues that may require joint resolution, such as milestone changes, political impacts on
objectives, schedule, funding anddeliverables. Meeting minutes provided by the Awardee delivered to the USG within 2 days of themeeting.
C.6.3. Quarterly In Process Reviews. Scheduled as needed, generally not more frequently than quarterly, virtual format (either
telephone or videoconference). Duration: 8 hrs max. Review of previous quarter's activities. Informative in nature to keep the USG
apprised of project progress and to discuss issues that may require joint resolution, such as milestone changes, political impacts on
objectives, schedule, funding. An agenda for the meeting provided by the Awardee 10 days prior to the scheduled meeting. Meeting
minutes provided by the Awardee delivered to the USG within 5 days of the meeting.
C.6.4. Final Report. Final Report shall NOT be marked proprietary, and shall have Distribution Statement C. Contractor format
acceptable. Electronic submission acceptable in MS Office or PDF format. Financial information shall be MS Excel format. Finalreport summarizing stated objectives and the progress that was achieved in meeting those objectives; summary of risks incurred,
impacts and mitigation; quantitative discussion of production throughput improvements achieved; financial summary of project;schedule summary for project, comparing original schedule to final schedule; recommendations for path forward as applicable. Final
Report due 5 days after the last scheduled delivery for prototype demonstration.
C.6.5. Manufacturing Plan. The Awardee shall provide a detailed plan of action (contractor format acceptable) to increase cartridgemanufacturing capability to meet the government's delivery schedule (i.e. ramp up to 100K cartridges per day) and associated onshoring component manufacturing within 15 days of contract award.
The Awardee's plan of action shall at a minimum, include the following:abTimeline, materials required and strategy to set up and begin V2.0 manufacturing lines to manufacture the cartridges;
Timeline, materials required and strategy to upgrade the bioproduction capability to manufacture sufficient cartridge reagents;
c

d
e

f
g

Timeline, materials required and strategy to onshore manufacturing of reagents and cartridge subcomponents;
Information on the US based manufacturing organization to replace existing organization;
Current GMP manufacturing status and plan to achieve GMP manufacturing, if not currently GMP;
Quality Assurance plan and Acceptance metrics;
Plan to comply with FDA EUA Letter of Authorization.

C.6.6. Distribution Plan. The Awardee shall provide a detailed distribution plan for how all Test Cartridge Packs,
Monitoring Systems and External Control Swabs Packs will be shipped and delivered to required delivery locations
within the United States and its Territories within 15 days of contract award.
The Awardee's distribution plan shall at a minimum, include the following: a Current distribution processes;
b Timeline and strategy to increase distribution process and shipping to handle the increase in number andvolume of shipments.
C.6.7 Quality Management Plan. The Awardee shall provide (contractor format acceptable) within 15 days ofcontract award, a quality management plan for manufacturing efforts that conform to ISO 13485 standards as wellas the Quality System Regulations at 21 CFR Part 820 which may include, but is not limited to, the quality policy
and objectives, management review, competencies and training, process document control, feedback, evaluation,corrective action and preventive action, process improvement, measurement, and data analysis processes. The
framework is normally divided into infrastructure, senior management responsibility, resource management,
lifecycle management, and quality management system evaluation.

Appendix B
Project Schedule/Milestone Payment Schedule
The Government shall pay the Awardee, upon the submission of proper invoices or vouchers, theprices stipulated in this Agreement for supplies delivered and accepted or services rendered andaccepted, less any deductions provided in this Agreement.
For the industrial expansion, expenditures shall be submitted based on the awarded budget. Federal
funds are to be used only for work that a reasonable and prudent person would incur in carrying out the
prototype project. An invoice will be submitted through Wide Area Work Flow (WAWF) in accordancewith agreement requirements. Final payment of the Agreement shall be determined upon mutual
agreement and settlement of any outstanding deliverables.
The Awardee shall proceed with the performance in accordance with the terms and conditions of thisAgreement and its Appendices. However, the Government may require the Awardee to cease
performance at any time prior to the commencement of any milestone or task. Such notice to cease
performance must be from the OTAO and be in writing, of which email is an acceptable form.
The Parties acknowledge that the nature of this Prototype Project requires flexibility and the ability
to react to changing circumstances. Although the Statement of Work sets the scope for activities theGovernment may require under this Agreement, it is not intended to, and does not, prescribe withspecificity each task that Awardee will perform. Instead, the Government shall direct Awardee toperform specific tasks under the framework established in Articles 3 and 8 of the Agreement, with

Government-approved tasks, funding, and deadlines. Awardee shall not perform any tasks that havenot been explicitly authorized by the Government.
Awardee will be responsible for submission of SOW's, quotes, and proposals for price, performance,and schedule for those efforts not already identified, priced or otherwise negotiated. Government
approval will be required prior to commencing work.

Appendix C
Key Personnel
1. Awardee's Organization and Key Personnel.
The Awardee's organization shall be established with authority to effectivelya.
accomplish the objectives of the Statement of Work. This organization shall become effective
upon award of the Agreement and its integrity shall be maintained for the duration of the effort.
The key personnel listed below are considered to be critical to the successfulb.
performance of this Agreement. Prior to replacing these key personnel, the Awardee shall obtain thewritten consent of the OTAO. In order to obtain such consent, the Awardee shall provide advancenotice of the proposed changes and shall demonstrate that the qualifications of the proposed substitutepersonnel are generally equivalent to or better than the qualifications of the personnel being replaced.
C.
Prior to permanently removing any of the specified individuals to other contracts,
the Awardee shall provide the OTAO not less than thirty (30) calendar days advance notice and shallsubmit justification (including proposed substitutions) in sufficient detail to permit evaluation of the
impact on the program. No reassignment shall be made by the Awardee without written consent of the
OTAO. The "Key Personnel" list presented in Table 2 below may be amended from time to time
during the course of the Agreement to either add or delete personnel, as appropriate.

Table 2: Key Personnel Summary

Appendix D Government
Property
Government Property: "Government Property" means any property (i) furnished by the Government andfacilitating performance of this Agreement, (ii) acquired by the Awardee under cost reimbursement terms ofthis Agreement, or (iii) acquired by the Awardee under fixed price terms of this Agreement (FP-GP) if
specifically identified in this Government Property Appendix. Except for commercial off the shelf softwareand licenses thereto, Government Property does not include intellectual property and software. The
Government owns and holds title to all Government Property.
The Government shall deliver to the Awardee any Government Property required to be furnished as described in thisAgreement together with related data and information needed for its intended use. The delivery and/or performancedates specified in this Agreement are based upon the expectation that the Government-furnished property will besuitable for performance and will be delivered to the Awardee by the dates stated in the Agreement. If not sosuitable, the Awardee shall give timely written request to the OTAO who will advise the Awardee on a course ofaction to remedy the problem.
FPGP includes: [Mark N/A if none]:N/A

The Awardee shall have, initiate and maintain a system of internal controls to manage, control, use, preserve,
protect, repair, account for and maintain Government Property in its possession and shall initiate and maintain theprocesses, systems, procedures, records required control and maintain accountability of Government Property.
The Awardee shall include this clause in all subcontracts under which Government Property comes into thepossession of any subawardee. Unless otherwise provided for in this Agreement or approved by the OTAO, theAwardee shall not: (i) use Government Property for any purpose other than to fulfill the requirements of thisAgreement, or (ii) alter the Government Property.
The Awardee shall establish and implement property management plans, systems, and procedures regarding its
acquisition of Government Property, its receipt of Government Property, in addition to, the status, dates furnishedor acquired, identification, quantity, cost, marking, date placed in service, location, inventory and disposition ofGovernment Property, to include a reporting process for all discrepancies, loss of Government Property, physicalinventory results, audits and self-assessments, corrective actions, and other property related reports as directed by
the OTAO.
Upon conclusion or termination of the Agreement, the Awardee shall submit a request in writing to the OTAO, fordisposition/disposal instructions and shall store Government Property not to exceed 120 days pending receipt ofsuch instructions. Storage shall be at no additional cost to the Government unless otherwise noted in the Agreement.
The Government, upon written notice toW911NF2190001
Page 33 of 40
the Awardee, may abandon any Government Property in place, at which time all
obligations of the Government regarding such Government Property shall cease.
Awardee Liability for Government Property. "Loss of Government Property" means

the loss, damage or destruction to Government Property reducing the Government's
expected economic benefits of the property and includes loss of accountability but does
not include planned and purposeful destructive testing, obsolescence, reasonable wear andtear or manufacturing defects. THE AWARDEE SHALL BE LIABLE FOR LOSS OF
GOVERNMENT PROPERTY IN AWARDEE'S POSSESSION, EXCEPT WHEN ANYONE OF THE FOLLOWING APPLIES:(I) OTAO GRANTS RELIEF OF RESPONSIBILITY AND LIABILITY FOR LOSS
OF THE PARTICULAR GOVERNMENT PROPERTY; (II) GOVERNMENTPROPERTY IS DELIVERED OR SHIPPED UNDER THE GOVERNMENT'S
INSTRUCTIONS AND SHIPPERS; OR (III) GOVERNMENT PROPERTY ISDISPOSED OF IN ACCORDANCE WITH THE GOVERNMENT'S DIRECTIONS.

W911NF2190001
Page 34 of 40
Section E - Inspection and Acceptance

INSPECTION AND ACCEPTANCE TERMS
Supplies/services will be inspected/accepted at:
CLIN
0001
0002
0003
0004

INSPECT AT
N/A
N/A
N/A
N/A

INSPECT BY
N/A
N/A
N/A
N/A

ACCEPT AT
N/A
N/A
N/A
N/A

ACCEPT BY
Government
Government
Government
Government

W911NF2190001
Page 35 of 40
Section F - Deliveries or Performance

DELIVERY INFORMATION
CLIN

DELIVERY DATEQUANTITYSHIP TO ADDRESSDODAAC /
CAGE

0001

08-APR-2021

1

JPM MEDICALJPM CBRN MEDICAL
1564 FREEDMAN DRIVE
FORT DETRICK, MD MD 21702
240-675-3192
FOB: Origin (Shipping Point)

W56XNH

0002

11-MAR-2021

6,000,000(SAME AS PREVIOUS LOCATION)
FOB: Origin (Shipping Point)

W56XNH

0003

11-MAR-2021

30,000(SAME AS PREVIOUS LOCATION)
FOB: Origin (Shipping Point)

W56XNH

0004

11-MAR-2021

60,000(SAME AS PREVIOUS LOCATION)
FOB: Origin (Shipping Point)

W56XNHW911NF2190001
Page 36 of 40
Section G - Contract Administration Data

ACCOUNTING AND APPROPRIATION DATA
AA: 0212020202120400000664643255
COST CODE: A5XAHAMOUNT: $480,916,636.62

S.0074658.5.22

6100.9000021001

ACRN

CL1N/SL1NON

AMOUNT

AA

0001
0002
0003
0004

GFEBS001156060100001
GFEBS001156060100002
GFEBS001156060100003
GFE,BS001156060100004(I)) (4 )(b) (4)(b) (4)(D) (4)