DEPARTMENT OF THE ARMY
U.S. ARMY CONTRACTING COMMAND — NEW JERSEYPICATINNY ARSENAL, NEW JERSEY 07806-5000
REPLY TOATTENTION OF
26 May 2020
Army Contracting Command — New Jersey
ACC-NJ, Building 9
Picatinny Arsenal, NJ 07806
SUBJECT: Technical Direction Letter for Medical CRBN Defense Consortium (MCDC), Request
for Prototype Proposals (RPP) 20-07, Objective DET-20-07 for "A Rapid Point of Care Assay for the
Detection of the Asymptomatic Carrier State of COVID-19" (New Horizons Diagnostics Corp.)
REF: Request for Updated Proposal Submitted in Response to RPP 20-07 under OTA W I 5QKN- 169-1002 for Objective DET-20-07, dated 14 May 2020
Advanced Technology International
ATTN: (b) (6), Senior Contracts Manager
315 Sigma Drive
Summerville, SC 29486
Dear (b) (6),The Army Contracting Command — New Jersey (ACC-NJ), in supporting the Joint Project Manager— Medical Countermeasure Systems (JPM-MCS), issued MCDC RPP 20-07 on 05 May 2020.
Members of the MCDC submitted proposals in accordance with this RPP. The Government received
and evaluated all proposal(s) submitted and a Basis of Selection has been executed, selecting New
Horizons Diagnostics Corp. (NHD) as the awardee. The Government requests that a Firm-FixedPrice Agreement be issued to NHD to award this proposal under Other Transaction Agreement
W15QKN-16-9-1002, to be performed in accordance with the attached Government Statement ofWork (SOW).
Based upon the acceptable update of NHD's proposal for "A Rapid Point of Care Assay for the
Detection of the Asymptomatic Carrier State of COVlD-19" and 1) The Project Agreement
Recipient's concurrence with the requirements included in the Government SOW; 2) An acceptable
milestone schedule that meets SOW requirements, and; 3) The Cost Proposal that has been analyzed
and negotiated final by the Government, you are hereby directed to issue a Project Agreement to NHD
for the subject project. The total project value has been determined fair and reasonable and NHD's
proposal has been selected IAW the above referenced Basis of Selection.
The total approved cost to the Government for this effort is not to exceed (b) (4)The breakout of the costs is as follows: $1,448,215.00 to perform project efforts included in the SOW andfor the Consortium Management Firm Administrative Fee. The effort currently has(b) (4)of available funding, comprised of $1,448,215.00 for the Project Agreement and(b) (4)for the Consortium Management Firm Administrative Fee of (b) (4)(b) (4)

This Project Agreement is anticipated to be incrementally funded. The Government reserves the rightto award future milestones/fund additional months of project tasks. If the Government decides to doso, the MCDC member will be notified via An The Government's liability will never exceed thecurrent amount of funding obligated under the Project Agreement. The Project Agreement Holder
shall notify All when they are approaching 75% of current funding obligated in incurred costs by
written notice.
The prime contractor is considered a small business, nontraditional defense contractor, or nonprofit
research institution and determined to be providing a significant contribution. The affirmation ofbusiness status certifications submitted as part of the proposal are hereby incorporated into theagreement. The contractor shall notify the MCDC CMF of any deviation from the fmal proposed
affumation of business status certifications that would affect the contributions of the small business,
nontraditional defense contractor, or nonprofit research institution as proposed.
In accordance with 10.U.S.C. 237 lb(f), and upon a determination that the prototype project for thistransaction has been successfully completed, this competitively awarded prototype OTA may resultin the award of a follow-on production contract or transaction without the use of competitive
procedures.
Points of Contact:
Agreements Specialist:
6)E-mail: b) (6)Phone: (Agreements Officer:(b) (6)E-mail: (b) (6)Phone: (b) (6)Regards,(b) (6)(b) (6)
Agreements Officer
Signed by: (b) (6)

Attachments:
Attachment 1: End 3_MCDC200 7-003 SOW_14May2020 revdpt2

Statement of WorkFor
Development of Prototype Diagnostic Tests for the Rapid andAccurate Diagnosis of Human SARS-CoV-2 Infection
RPP #: 20-07
Project Identifier: MCDC2007-003
Consortium Member: New Horizons Diagnostics Corp. (NHD)
Title of Proposal: A Rapid Point of Care Assay for the Detection of the Asymptomatic CarrierState of COVED-19
Requiring Activity: Defense Threat Reduction Agency (DTRA), Diagnostics/Detection
Division (CBA)
1.0

INTRODUCTION, SCOPE, AND OBJECTIVES

1.1

Introduction

In response to the ongoing global Coronavims Disease 2019 (COV1D-19) pandemic, the Defense
Threat Reduction Agency (DTRA), Joint Science and Technology Office (JSTO), in conjunction
with the Joint Program Executive Office (JPEO), is interested in the rapid development, testing,and fielding of reliable and accurate tests that can be used to identify exposure to Severe AcuteRespiratory Syndrome Coronavirus 2 (SARS-CoV-2). This pandemic has become a national
security issue, affecting Department of Defense (DoD) Service members and their operational
readiness across the world.
Since the outbreak of this novel coronavirus began in the United States, the principal diagnostic
testing regimen utilizes a molecular test prepared by the Centers for Disease Control (CDC). Thishigh complexity assay requires nasal pharyngeal swab collection and transport to a laboratory,
nucleic acid extraction, and subsequent analysis. Sensitive and precise, it detects the presence ofthe virus Ribonucleic Acid (RNA) in the patient. As of April 2020, many other molecular tests
have achieved Emergency Use Authorization (EUA) from the Food and Drug Administration(FDA). The FDA has issued an EUA for molecular assays, including the Biofire COVID-19 test,
and Cepheid's Xpert Xpress SARS-CoV-2 test—these approvals pave the way for inclusion of
COVID-19 diagnostic testing on DoD's Next Generation Diagnostics System (NGDS) family of
platforms, and accelerate the rollout of these testing capabilities across US military installations.
Molecular testing will continue to be critical in the identification and control of COV1D-19, inorder to protect the health of the warfighter.
However, there are applications for which these existing molecular diagnostic tools aresuboptimal. In situations when viral RNA is not detectable, molecular diagnostics alone are
ineffective for identifying exposure to SARS-CoV-2. Serological tests (also called antibody tests)
may complement molecular assays in these situations, to enhance diagnostic accuracy, especiallylate in infection. Serological assays measure the patient's immune response to an infection. Several
days after initial infection, the body's adaptive immune response begins to produce antibodies.
During the initial response, specific IgA and IgM (Immunoglobulins) molecules begin to circulate.
offers protection, particularly for respiratory pathogens that enter through the lungs(b)(4)1or (b) (4) membranes. The presence of specific IgM is indicative of an ongoing infection and the
body's attempt to clear the pathogen. In the days following the steep IgM rise, a class switching
recombination to IgG subtypes is observed. The IgG antibodies tend to persist for a longer periodof time and provide immunological "memory" to prevent re-infection. Certain groups of
predominantly IgG antibodies are considered "neutralizing," as these are capable of binding andpreventing viral infection of host cells. This is a novel Coronavirus, and current literature suggeststhat individual titers of immunoglobulins (IgA, IgM, IgG, and neutralizing antibodies) generated
in response to SARS-CoV-2 infection, are highly variable. It is also currently unknown whether
the presence of any of these antibodies confer protection from illness due to re-infection, and if so,
what antibody titers are protective. In spite of these knowledge gaps, COVID-19 antibody tests are
expected to support Force Health Protection by delivering critical information on burden of
infection, disease pathogenesis, asymptomatic infections, basic reproduction number, and theoverall mortality of the COVID-19 among military personnel. Additionally, point-of-care tests
targeting SARS-CoV-2 antigens, or the antibody response, are expected to further support rapid
diagnosis and screening. There is also a need for laboratory based confirmatory serological tests.
This virus is not only spread by those visibly sick, but also by individuals who are not aware theyharbor the virus. In fact, in the state of Washington, the first significant outbreaks in the UnitedStates, more than half of the residents of a Seattle-area nursing home with an early outbreak of
COVID-19 cases, who tested positive for SARS-CoV-2, were asymptomatic. Of the 76 residentsof the nursing home, 48 (63%) tested positive; of the 48 who tested positive, 27 (56%) wereasymptomatic at the time of testing. 24 residents subsequently developed symptoms with themedian time to symptom onset of 4 days. Specimens from these 24 viral-positive patients who
were pre-symptomatic at testing (71%), had viable virus culture 1 to 6 days before developing
symptoms. Transmission from asymptomatic individuals infected with SARS-CoV-2, most likely
contributed to the rapid and extensive spread of infection to other residents, staff and beyond.
In another example, USS Theodore Roosevelt from March to April 2020, a number of crew
members became infected with COVID-19 during a shore-leave in Vietnam. Subsequently, thevirus spread throughout the ship. From the testing of 4,900 crew (94% tested), 600(12.5%) tested
positive with 360 of those (60%) asymptomatic. This further underscores the threat that this virus
may pose, and accentuates the need to easily and rapidly screen asymptomatic, or those withminimal symptoms of the virus. A further gap is the ability to triage those sick with the normal flu
and COVID-19.
1.2

Scope

Throughout the industry, many have proposed the extensive use of serological, antibody-based
assays. Most antibody tests detect IgG and IgM to determine if a person has previously been
infected with COVID-19, an indication that they've had the virus and now may be immune to thevirus (SARS-CoV-2). They may also be used for contact tracing. Many of these assays are notspecific and do not determine immunity
As previously mentioned, the most common assay to detect the virus in nasopharyngeal samples,is the real-time Reverse Transcriptase Polymerase Chain Reaction (PCR) (rRT-PCR). The PCR
assay, however, requires sophisticated equipment and complex, expensive test reagents.

2

Additionally, the nasopharyngeal sample is not conducive to self-collection. A rapid and simple
point of care assay which only requires a ( b ) (4) sample, which would offer convenience and easeof use, combined with accuracy, would provide significant benefit to disease management. The
assay would allow for continuous and simple monitoring,(b) (4)determining presence of SARS-CoV-2, and allowing for the control of infected individuals andreduction in the spread of the COVID-19. This would be a state-of-the-art, rapid COVID-19 Pointof-Care (POC) viral screening assay.
This prototype project will provide diagnostic and detection capability, in order to individually
identify the causative agent of the COVID-19 via (b) (4)samples and IgA, IgM, and IgG from blood and sera, as well as other samples. The proposed
diagnostics will have clinical sensitivity at or greater than 90%, with clinically relevant samples
such as ) b) 4)
for the LFI, as well with Enzyme-Linked Immunosorbent
Assay (ELISA) using whole blood, capillary blood, plasma, serum and others. For COVID-19, theutilization of( b) (4)has the potential to detect asymptomatic and symptomatic, including
carriers of SARS-CoV-2. The utilization of (b ) (4) with the LFI assay, allows for the simple POC
use. The proposed diagnostic technology will be ready for pre-submission for FDA EUA
clearance, at the conclusion of this project.
1.3

Objective

This prototype project seeks to develop a complementary diagnostic capability, to be used inconjunction with NGDS, in support of the Warfighter. The capability will be developed rapidly,
in order for its benefits to impact the course of the current outbreak. In accordance with theGovernment's request, NHD's proposed diagnostic capability will complement the existing NGDS
family of systems, to improve patient health outcomes and force health decisions, and align with
JSTO's internal technology development strategy. NHD's development efforts may also produce
reagents that enhance the development or accuracy of these desired diagnostic tests (e.g. highquality antigens, antibodies, or SARS-CoV-2 antigen assays that may be used at the point-of-care).
The assays need to meet the current standards set by the FDA guidance for EUA for COVID-19
assays. These standards are evolving as the Government learns more about human immunologicalresponses, and as more diagnostic tests are approved, and the promise and perils associated with
their use is reported. MID will provide assays for independent validation and verification to afederal laboratory identified by DTRA at the end of phase 1. In phase 2, NBD will also need topursue FDA EUA authorization, and be prepared to scale up production of their diagnostic assays
to meet the anticipated demands.
This is a prototype project because NHD will develop a Point of Care Lateral Flow Assay for
detection of ( b) (4)associated with the COV1D-19, to evaluate the technical feasibility ofusing the assay to determine asymptomatic and symptomatic COVID-19 infection, by use of asimple, easy to obtain (b) (4) sample. This assay will allow for the triage of patients, as well as
identify the asymptomatic potential carriers/spreaders of the SARS-CoV-2. This will assist in
maintaining military readiness, control resources, and save lives.
(10) (4)3

(b) (4)This assay can be performed at home, work, forward deployed, etc. This is a typicalClinical Laboratory Improvement Amendments (CLIA)-like waived format.
Considering the ( b (41target is novel, there will be a need for clinical testing of a work-inprocess first generation prototype. After challenged with the actual patient samples, there will bean opportunity for further optimization. After this modification, there will be further testing, nowof the second generation prototype. This is the Go/No-Go point. If successful at detecting, then
expanded testing for EUA submission can be performed. The initial first generation prototype will
be provided after the first 2-3 months of development. Including further development with firstand second generation testing, prior to scale up, the acceptable prototype (after 2nd generation)
may be available after 3-5 months. Further testing in compliance with FDA requirements, as well
as scale-up, will result in as much as 7-8 months of project schedule.
In accordance with 10.U.S.C. §2371b(f), and upon a determination that the prototype project forthis transaction has been successfully completed, this competitively awarded prototype OTA may
result in the award of a follow-on production contract or transaction without the use of competitive
procedures. If follow-on production is desired by the Government, production would need tosupport approximately 20,000 advanced prototypes for testing and evaluation, and significant
production to support the United States requirements to support the COVID-19 response, withpotentially hundreds of thousands needed. This prototype project will be successfully completed
if the contractor meets the key technical goals of the project, as listed within this document, meetsthe success metrics established by this agreement or, at the accomplishment of particularly
favorable or unexpected results that justifies transition to production.
If there is a conflict between the Project Agreement and the Base Agreement, the Project
Agreement language will supersede and control the relationship of the parties.
2.0

APPLICABLE REFERENCES

Documents incorporated as part of the requirements, include the current FDA Guidance: "Policy
for Diagnostic Tests for Coronavinis Disease-2019 during the Public Health Emergency," Revised
May 11,2020.
3.0

REQUIREMENTS

For this prototype project, NHD will develop FDA-EUA authorized diagnostic lateral flow assays
for the detection of ( b ) (4 ), as an indication of COVID-19 infection in clinical (b) (4)samples. A second objective is NHD development of a standard ELISA format for detection of
IgA, IgM, and IgG in blood and sera for a serological assay, for an indication of exposure andpotential protection. Additionally, NHD will work to allow for detecting these targets in otherclinical samples, as a potential field standard method.

4

Project Tasks and Risk 1. NHD shall develop a lateral flow assay for the (b) (4)from ( 6 )(4) samples.

Technical Task: (a) NHS shall optimize (b) (4)antibody detection in a lateral flow assay; Final lateral flow assay for IgA related targets directfrom ( b) (4) sample.
antigens are available, and the initial (b) (4)has been utilized in a prototype serological assay. Several gis
antibodies are available commercially. One of these antibodies has been utilized in serologicalassay. Conversely, if (b) (4)antibodies are needed, the (b) (4) has also been utilized in alateral flow format. Other antibodies are also available. The various formats will be included in
the first generation prototype testing, in order to determine the more sensitive and specific format
selected for optimization.

Risk: The (b) (4)2. NHD shall test and demonstrate clinical (b) (4) matrixes are suitable for the detection of(b) (4) in the diagnosis of COVID-19 in a lateral flow assay developed in objective 1.
Technical Tasks: (a) NHD shall use the lateral flow assay to detect clinically relevant
concentrations of (b) (4)samples.
is low,
Risk: The (b) (4) Matrix will not meet detection requirements. Risk for (b) (4)as there are commercially available (b) (4) collection kits, and there is significant 3rd party data
supporting performance o (b) (4) as sample for (t) (1)(b) NM shall execute appropriate clinical trials of thediagnosis.

lateral flow assay for COVID-19

Risk: Lateral Flow Immunoassay will not meet requirements. The clinical trials will not be initiatedunless parameters are met in the lab testing, and after the first generation prototype provides atleast minimally acceptable results, in terms of detection. Historical experience with clinicalsamples with the LFI, minimi7es overall risk.
3. NHD shall develop an ELISA test with antigens and antibodies against IgA, IgM, and IgG
for the determination of immune response to the COV1D-19 in whole blood, as well as
detection of the targets in other samples.
Technical Task: (a) NHD shall develop an ELISA test for IgA, IgM, and IgG antibodies in sera or
blood, with high specificity and sensitivity.
Risk: The ELISA is not sufficient or sensitive to detect the specific IgA, IgM, and IgG antibodies.
The ELISA format is well-known and the antigens from b) (4) have been evaluated in other formats
with acceptable results. Other antigens and antibodies are commercially available.

54. NHD shall execute appropriate clinical trials of the ELISA for IgA, IgM, and IgG for
determination of exposure to COVID-19 in blood or sera.
Risk: The ELISA format provides for unacceptable performance in development of assay, andwould prevent clinical trials. Risk as stated above, is minimal. The assay will be evaluated during
the first generation prototype testing.
Project Technical Tasks Summary 1.NHD shall optimize antigens (b) (4)and antibod (b) (4) complex for LFI and IgA, IgM,
and IgG for the ELISA format for the COVID-19. (NHD will determine the optimum antigens andantibodies)
2. NHD shall optimize the lateral flow assay for related antigens (b) (4)and antibodies forin buffer and simulated samples, and IgA, IgM, and IgG in ELISA. (NHD will transfer
optimized antigens and antibodies in the formats)agi

3. NM shall use the lateral flow assay and ELISA to detect clinically relevant concentrations oftargets in buffer, simulated sample, whole blood samples or serum samples. (NHD willconcurrently evaluate COTS (b) (4) collection kits)
4. NHD shall conduct a field trial of the lateral flow assay (separate LFI for (b) (4)) and
ELISA IgA, IgM, and IgG for COVID-19 diagiosisidetection. (NHD will conduct appropriate
clinical sample testing of first generation prototypes)
5. NHD shall optimize Lateral flow Immunoassay for the detection of (b) (4)IgA, IgM, and IgG for high specificity and sensitivity.

and ELISA

6. MD shall use the lateral flow assay to detect clinically relevant concentrations of (b) (4)samples and ELISA format to detect IgA, IgM, and IgG in blood, sera and other samples. (NHD
will conduct appropriate clinical sample testing of second generation prototypes)
7. NI-ID shall conduct bench testing of the lateral flow assay for ggi and ELISA for IgA, IgM, and
IgG.
8. NHD shall conduct all activities to execute scale-up of the LFI and ELISA systems.
9. NHD shall conduct all activities required for submission of EUA of the LFIELISA IgA, IgM, and IgG in sera and blood, as well as other samples for COVlD-19.
Technical Strategy and Innovations 1. Demonstrate and test clinical (b) (4) matrixes suitable for detection of (b) (4)diagnosis of COVID-19 with the lateral flow assay developed in objective 1.

, for the6Technical Solution: The (b) (4) sample matrixes will be tested as the clinical samples to apply tothe assay. If necessary, a (b) (4)agent may be added to enhance presentation of the MN to theassay, and provide improved assay performance.
2. The LFI and ELISA require improved sensitivity and specificity.
Technical Solution: Review available (b) (4)as well asRE antibodies from the (b) (4 andother sources. Additionally, engage the use of (b) (4)3. Improved sensitivity of LFI (b)(4)Technical Solution: NHD Standard Operating Procedures (SOP) will be used to (b) (4)4. Improved binding and "clean results" (b) (4)Technical Solution: Using NHD SOP (b) (4)Mandatory Reporting Quarterly Reports: The MCDC awardee shall prepare a Quarterly Report, which will include aTechnical Status Report and a Business Status Report, in accordance with the terms and conditionsof the MCDC Base Agreement.
Annual Technical Report: The MCDC awardee shall prepare an Annual Technical Report for
projects whose periods of performances are greater than one (1) year, in accordance with the terms
and conditions of the MCDC Base Agreement. This may be combined with the concurrent
quarterly report.
Final Technical Report: At the completion of the project, the MCDC awardee will submit a Final
Technical Report, which will provide a comprehensive, cumulative, and substantive summary of
the progress and significant accomplishments achieved during the total period of the project, in
accordance with the terms and conditions of the MCDC Base Agreement. Once the MCDC
management firm has informed the MCDC awardee that the Final Technical Report has been
approved by the Government, the MCDC awardee shall forward a copy to the Defense Technical
Information Center, Attn. DTIC-0, 8725 John J. Kingman Road, Suite 0944, Fort Belvoir, VA
22060-6218.

7

Final Business Status Report: At the completion of the project, the MCDC awardee will submit
a Final Business Status Report, which will provide summarized details of the resource status of
the project, in accordance with the terms and conditions of the MCDC Base Agreement.
Project Task Timeframe:
Task
1 Assa Dem :etc.:
FDA EUA Preparation
Preliminary Design Review
2 Antigen and Antibody Chemistries Development:
COVID-19 Antigen Prototype Optimization
COV1D-19 Antibody Prototype Optimization
3 Assay and Sample Conditions: (can be concurrent with #s 1 & 2)
Positive and Negative Controls Development
4 First Generation Prototype Field Testing: (PCR, ELISA, Serological, & tomtimize for Clinical Matrices
5 Optimization of Device, Combining Chemistries into Assay System
Bench Studies Meeting/Protocols Development
6 Second Generation Prototype Testing and Revision
Conduct Bench-Field Studies
7 Production Scale up, Stability, Additional Analytical Testing
Develop and Submit Bench Studies Reports
8 FDA EUAFDA EUA Approval Phase Support
9 Prototype Project Management and Reporting
10 FDA, Microbiolo , andConsultant Su oil
11 Quality Control Inspection, Testing, and Monitoring
Total Period of Performance:

Timeframe
2-4 weeks

4-6 weeks

2-4 weeks
2-3 weeks
1-3 weeks
2-4 weeks
3-4 weeks
4-8 weeks
35 weeks
35 weeks
35 weeks
35 weeks

Project Deliverable Tasks
Del. #
3.1
3.2
3.3
3.4
3.5
3.6
3.7
3.8
3.9
3.10
3.11
3.12

Deliverable Description
FDA EUA Teleconference Meeting Minutes
Preliminary Design Specifications for LFI/ELISA
Preliminary Design Review Meeting Minutes
Draft Package Insert
First Prototype Pre-Clinical Testing Study Report
Risk Analysis Master Record
Second Prototype Selection Meeting Minutes
Design Transfer Meeting Minutes
Bench Study Meeting Minutes
Bench Study Protocols
Clinical Study Meeting Minutes
Design Verification Meeting Minutes

Due
Date
6/15/20
6/30/20
6/30/20
7/31/20
8/31/20
8/31/20
9/30/20
9/30/20
8/31/20
8/31/20
8/31/20
9/30/20

8

3.13
3.14
3.15
3.16
3.17
3.18
3.19
3.20
3.21
4.0

Monthly/Quarterly Progress and Financial Status Reports
Final Closeout Report - Due 30 days after Completion of Effort
Draft Device Master Record
Device History Record for Three (3) Lots
Final Bench Study Protocols
Limit of Detection/Matrix Comparison
Bench Study Reports
Final Clinical Study Protocol
Second Prototype Clinical Study

6/30/20-12/31/20
1/31/2021
10/31/2020
12/31/2020
10/31/2020
10/31/2020
9/30/2020
10/31/2020
10/31/2020

DELIVERABLES
Due
Date
6/15/20

Milestone SOW
Ref
Ref
5.1
3.1

Gov't
Role
Review/
Comment

Govt
purposePreliminary design
specifications for
LFI/ELISA

6/30/20

5.2

3.1

Review/
Comment

Govt
purpose

4.3

Preliminary design review
meeting minutes

6/30/20

5.2

3.1

Review/
Approve

Govt
purpose

4.4

Draft package insert

7/31/20

5.4

3.5.1

Review/
Comment

Govt
purpose

4.5

First prototype pre-clinicaltesting & study report

8/31/20

5.6

3.2.7

Review/
Comment

Govt
purpose

4.6

Risk analysis masterrecord8/31/20

5.6

3.1

Review
Comment

Govt
purpose

4.7

Second prototype
selection meeting minutes

9/30/20

5.8

3.1

Review/
Approve

Govt
purpose

4.8

Design transfer meeting
minutes

9/30/20

5.8

3.4.3

Review/
Comment

Govt
purpose

4.9

Bench study meeting
minutes

8/31/20

5.6

3.5.1

Review/
Comment

Govt
purpose

4.10

Bench study protocols

8/31/20

5.6

3.5

Review/
Comment

Govt
purpose4.11

Clinical study meeting
minutes

8/31/20

5.6

3.7.1

Review/
Comment

Govt
purpose

4.12

Design verification
meeting minutes

9/30/20

5.8

3.5

Review/
Comment

LimitedDel. #

Deliverable Description

4.1

FDA EUA teleconference
meeting minutes

4.2

Data Rights

9

4.13

Monthly/Quarterly
progress annual andfinancial status reports

6/30/2012/31/20

5.3,5.5,
5.7, 5.9,
5.11, 5.13

3.3

Review
Approve

Govt
purpoe4.14

Final closeout report - due
30 days after completionof effort

1/31/2021

5.16

3.3

Review/
Approve

Govt
purpose

4.15

Device master record

10/31/2020 5.10

3.6.1

Review/
Comment

Limited4.16

Device history record forthree (3) lots

12/31/2020

5.16

3.6

Review/
Comment

Limited

4.17

Final bench study
protocols

10/31/2020 5.10

3.5.2

Review/
Comment

Govt
purpose

4.18

Limit of detection/matrix
comparison

10/31/2020 5.10

3.5.5

Review/
Comment

Govt
purpose

4.19

Bench study reports

9/30/2020

5.8

3.5.16

Review/
Comment

Govt
purpose

4.20

Final clinical study
protocol10/31/2020

5.20

3.7.2

Review/
Comment

Govt
purpose

4.21

Second generation clinicalstudy

10/31/2020 5.10

3.7.9

Review/
Comment

Govt
purpose

5.0

MILESTONE PAYMENT SCHEDULEMS #Task #

5. 1

31

5. 2

3.2
3.3

5.3
5.4

5. 5
5.6

3.2
3.3

3. 5

3.3

Milestone Description( Deliverable Reference)
FDA EUA Discussions, Initial Team
Teleconference, FDA EUA Teleconference Meeting
Minutes; Deliverable 4.1
Initial LFI Prototype, Initial ELISA Prototype,
Design Specifications; Deliverable 4.2
Preliminary Design Review Meeting Minutes;
Deliverable 4.3
Quarterly Report; Deliverable 4.13
Optimization Data, Revised Design Specifications,
Revised Design Plan, Initial Positive/Negative
Controls, Initial Clinical Matrices, Initial Draft
Package Inserts; Deliverable 4.4
Monthly Report; Deliverable 4.13
Bench Study Meeting Minutes; Deliverable 4.9
Bench Study Protocols; Deliverable 4.10

Due Date

Total
ProgramFunds

6/15/2020

b 4

6/30/2020
6/30/2020

b 4

7/31/2020
7/31/2020(b) (4)

8/31/2020

li

10

5.7
5.8

5.9
5.10

3.5
3.3

3.5
3.4
3.3
3.2

5.11
5.12

3.6

5.13
5.14

3.3
3.6

5.15
5.16

3.6
3.7

Optimize for Clinical Matrices; Deliverable 4.11
First Prototype Pre-Clinical Testing, Revised
Draft Package Insert, Initiate Bench Study Reports;
Deliverable 4.5
Risk Analysis Master Record; Deliverable 4.6
Monthly Report; Deliverable 4.13
8/31/2020
Remaining Bench Study Reports; Deliverable 4.19
Prototype Selection Meeting Minutes; Deliverable
4.7
Design Transfer Meeting Minutes; Deliverable 4.8
SOPs, Design Verification Meeting Minutes;
Deliverable 4.12
9/30/2020
Annual Report; Deliverable 4.13
9/30/2020
Operator Training, Training AAR, Initiate FDA
EUA Phase, Device Master Record; Deliverable
4.15
Final Bench Study Protocols; Deliverable 4.17
Limit of Detection/Matrix Comparison; Deliverable
4.18
Final Clinical Study Protocol; Deliverable 4.20
Clinical Study Report; Deliverable 4.21
Lot 1 - Initiate Production of 1,000 LFI Devices/100
10/31/2020
ELISA Devices, Second Gen Clinical Study; 4.21
Monthly Report; Deliverable 4.13
10/31/2020
Lot 2 - Initiate Production of 1,000 LFI Devices/100
ELISA Devices, Deliver 1,000 LFI Devices/100
ELISA Devices
11/30/2020
Monthly Report; Deliverable 4.13
11/30/2020
Lot 3 - Initiate Production of 1,000 LFI Devices/100
ELISA Devices
12/31/2020
Quarterly Report; Deliverable 4.13
12/31/2020
FDA EUA Submission Package, FDA Comments,
FDA Response Document, Device History Record;
Deliverable 4.16
Closeout Report; Deliverable 4.14
1/31/2021
Total Cost (FFP):
Period of Performance:(b) (4)(b) (4)(b) 4( b) (4)$1,448,215
8 Months*The Due Dates and Funding Amounts listed in this Milestone Schedule are contingent upon funds
available. In accordance with Section 5, Incremental Funding, this Project Agreement is funded at
the amount specified, and any work performed in excess thereof shall be at the Project Agreement
Holder's risk.
SHIPPING PROVISIONS
6.0
The contractor shall submit Quarterly, Annual, and final reports in accordance with the Base
Agreement to deliverables.mcdc.ati.org. All deliverables intended for the AOR shall be deliveredin electronic format to the AOR and alternate AOR, as identified within this document.
A copy of all data deliverables shall be sent to:11usannv.detrickdod-ipeo-cbnulmatotadelivembleamaiLmil
7.0

DATA RIGHTS AND COPYRIGHTS

The contractor shall comply with the terms and conditions defined in the MCDC Base Agreement.
The table below identifies pre-existing technical data and computer software with restrictions that
may be used during performance of this Agreement. The Government shall receive a Government
Purpose Rights license to all technical data and computer software developed and delivered under
this Agreement, except for the pre-existing technical data and computer software that waspreviously developed exclusively at private expense and identified in the table below. To the
maximum extent practicable, segregable portions of deliverables that will be restricted shall beclearly identified and labeled. If, after award, the contractor wishes to use any other internallydeveloped technical data or computer software, or any other pre-existing proprietary information
not identified in the table below, then the contractor shall disclose its intent in writing to the MCDCCMF prior to its use, and shall receive written approval from the Agreements Officer prior toproceeding. All technical data and computer software developed or delivered under this Agreement
shall have appropriate data rights markings in accordance with DFARS 252.227-7013(f) and7014(f). The contractor asserts that all contractor owned or background patents that affect theGovernment's rights in the deliverables anticipated under this Agreement are identified in the tablebelow.
Technical Data to be
Furnished with
Restrictions
Assay production methods

Basis for
Assertion

Deliverables
AffectedCategory
Limited rights

Name of Corporation
AssertingRestrictions

NHD Corp.

3.2, 3.3, 3.4,
3.4.4, 3.5,
3.6, 3.7, 3.8

Developed at
privateexpenseLimited rights

NHD Corp.

3.2, 3.3, 3.4,

Use AEI for detection
Developed atof b) [4)Covid-19 private
expenseLimited rightsb)14 ,

7.1

Developed at
privateexpenseAsserted
Rights

3.4.4, 3.5,
3.6, 3.7, 3.8

NHD Corp.

All

Government Rights

The Project Agreement Holder (PAH) agrees to the following:a. The PAH will provide to the Government all data including top-line summaries and key
conclusions from all studies supporting the regulatory filing and commercial approval to the extent
12that such data, summaries, and conclusions are funded by this agreement. In addition, the PAH
will offer the Government the opportunity to review and provide comments on a final draft ofregulatory submissions which include data funded by this agreement. The Government will review
any such submissions promptly upon receipt. The PAH will reasonably consider any comments
provided by the Government, and prior to submission will provide notification to the Governmentof any additional edits or revisions. The PAH will keep the Government apprised of planned FDA
meetings and post-meeting outcomes relating to activities funded by this agreement.
b. Communications. PAH will provide the Government with copies of all communications, bothformal and informal, to or from FDA, regarding the Technology within 48 hours, and ensure that
the Government representatives are invited to participate in any formal or informal Sponsor
meetings with FDA;
c. Non-compliance with section (a. & b.) may result in termination of the agreement.
d. Product Development Failure. Certain product development failures may trigger certain
remedies in Section "e." below for the Government advanced developer funding the developmentof this Technology. This remedy is not available to the Government for any cause outside of thefollowing:(i) if this agreement is terminated for nonperformance,(ii) the PAH fails to obtain FDA approval within the operationally relevant timeframe
determined by the Government after the award of this agreement (e.g., 3 years), when FDA
approval is a requirement;(iii) the PAH fails to commercially market or provide an acceptable life cycle plan for continued
supply of the Technology within three (3) years after FDA approval, licensure or clearance;(iv) the PAH gives notice, required to be submitted to the Government no later than thirty (30)business days, of any formal management decision to terminate this product development effort
pre-market or to file for Federal bankruptcy protection.
e. If any of the product development failures listed in Section "d." occur, the PAH, upon the requestof the Government:(i) shall transfer possession, ownership and sponsorship or holdership of any Regulatory
Application (including any associated expedited review designation, priority review voucher, or
marketing exclusivity eligibility or award), regulatory correspondence, and supporting regulatory
information related to the Technology, to the Government or its designee;(ii) shall inform FDA of the transfer of sponsorship or holdership of the Regulatory Applicationtransferred under section (e)(i) above;(iii) shall negotiate in good faith a non-exclusive license, at customary industry rates and underreasonable terms and conditions, to any patent, copyright or other intellectual property owned or

13controlled by the PAH, developed prior to or outside the scope of this agreement, or any technicaldata that is necessary for the Government to pursue commercialization of this technology with athird party for sale to the Government or otherwise.
f. This clause will survive the acquisition or merger of the PAH by or with a third party. Thisclause will also be included in any subcontracts/sub-agreements relating to the development of theTechnology. This clause will survive the expiration of this agreement.
8.0

SECURITY

The security classification level for this effort is UNCLASSIFIED. The contractor shall comply
with the terms and conditions defined in the MCDC Base Agreement, as applicable.
9.0

MISCELLANEOUS REQUIREMENTS (SAFETY, ENVIRONMENTAL, ETC.)

N/A
10.0

GOVERNMENT FURNISHED PROPERTY/MATERIAL/INFORMATION

N/A
11.0

AGREEMENTS OFFICER'S REPRESENTATIVE (AOR) AND ALTERNATEAOR CONTACT INFORMATIONAOR
Name:wito
Telephone: (b) (6)E-mail: (b) (6)
Office Symbol: DTRA RD-CBA

Alternate AOR
Name: .(b) (6)Telephone: (b) (6)E-mail: (b) (6)
Office Symbol: DTRA RD-CBA

14

DEPARTMENT OF THE ARMY
U.S. ARMY CONTRACTING COMMAND — NEW JERSEYPICATINNY ARSENAL, NEW JERSEY 07806-5000
REPLY TOATTENTION OF
07 July 2020
Army Contracting Command — New Jersey
ACC-NJ, Building 9
Picatinny Arsenal, NJ 07806
SUBJECT: Technical Direction Letter for Medical CRBN Defense Consortium (MCDC), Request forPrototype Proposals (RPP) 20-07, Objective 20-07 Ceiling Increase Modification for "A Rapid Point ofCare Assay for the Detection of the Asymptomatic Carrier State of COVID-19"
REF: Request for Updated Proposal Submitted in Response to RPP-20-07 under OTA W15QKN-16-91002 for Objective 20-07 Modification, dated 17 June 2020
Advanced Technology International
ATTN (b) (6), Senior Contracts Manager
315 Sigma Drive
Summerville, SC 29486
Dear (b) (6)The Army Contracting Command — New Jersey (ACC-NJ), in supporting the Joint Project Manager —Medical Countermeasure Systems (JPM-MCS), issued a Request for Proposal Update under MCDC RPP20-07, Objective 20-07 on 17 June 2020 to Advanced Technology International, for distribution to New
Horizons Diagnostics Corp. (NHD). This request would allow NHD to incorporate tasks for a protein
microarray using synthetic peptides, representing protein antigens that capture the potential future diversityof the evolving novel Coronavirus (SARS-CoV-2). The Government received the proposal update on 29
June 2020, and evaluated the costs and documentation accordingly. Based on the acceptable update of
NHD's proposal, the Government is increasing the Project Agreement ceiling value by $1,461,544.00, from
$1,448,215.00 to $2,909,759.00. The Government is also increasing the MCDC CMF Administrative Cost
Ceiling by (b) (4), from (b) (4)to (b) (4)Please see the below table for additional details.

Member Ceiling
MCDC Admin Cost
MCDC Admin Fee
Total

MCDC2007-003
Current Ceiling$1,448,215.00

MCDC2007-003
Proposed Increase$1,461,544.00

MCDC2007-003
Revised Ceiling$2,909,759.00(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)Work will be performed in accordance with the SOW, entitled, "End 3_MCDC2007-003 rev
DPTverJun8_ACCREV_SR Edit 6.22 v6 DPT4" (See Attachment 1). NHD should utilize the not-to-exceed
existing obligation amount of $1,448,215.00 to continue work on the project. This Project Agreement isanticipated to be incrementally funded. The Government reserves the right to award future milestones/fund
additional months of project tasks. If the Government decides to do so, the MCDC member will be notified
via ATI. The Government's liability will never exceed the current amount of funding obligated under the
Project Agreement. The Project Agreement Holder shall notify ATI when they are approaching 75% of
current funding obligated in incurred costs by written notice.

The prime contractor is considered a small business, nontraditional defense contractor, or nonprofit research
institution and determined to be providing a significant contribution. The affirmation of business status
certifications submitted as part of the proposal are hereby incorporated into the agreement. The contractor
shall notify the MCDC CMF of any deviation from the final proposed affirmation of business status
certifications that would affect the contributions of the small business, nontraditional defense contractor, or
nonprofit research institution as proposed.
In accordance with 10.U.S.C. 2371b(f), and upon a determination that the prototype project for thistransaction has been successfully completed, this competitively awarded prototype OTA may result in theaward of a follow-on production contract or transaction without the use of competitive procedures.
Points of Contact:
Agreements Specialist:(b) (6)E-mail: (b) (6)Phone: 1(b) (6)Agreements Officer:(b) (6)E-mail: (b) (6)Phone: ((b)(6)
Regards.

b) (6)

Agreements Officer
Signed by: (b) (6)

Attachments:
Attachment 1: End 3_MCDC2007-003 rev DPTverJun8_ACCREV_SR Edit 6.22 v6 DPT4

Statement of WorkFor
Development of Prototype Diagnostic Tests for the Rapid andAccurate Diagnosis of Human SARS-CoV-2 Infection
RPP #: 20-07
Project Identifier: MCDC2007-003
Consortium Member: New Horizons Diagnostics Corp. (NHD)
Title of Proposal: A Rapid Point of Care Assay for the Detection of the Asymptomatic CarrierState of COVID-19
Requiring Activity: Defense Threat Reduction Agency (DTRA), Diagnostics/Detection
Division (CBA)
1.0

INTRODUCTION, SCOPE, AND OBJECTIVES

1.1

Introduction

In response to the ongoing global Coronavirus Disease 2019 (COVID-19) pandemic, the Defense
Threat Reduction Agency (DTRA), Joint Science and Technology Office (JSTO), in conjunction
with the Joint Program Executive Office (JPEO), is interested in the rapid development, testing,and fielding of reliable and accurate tests that can be used to identify exposure to Severe AcuteRespiratory Syndrome Coronavirus 2 (SARS-CoV-2). This pandemic has become a national
security issue, affecting Department of Defense (DoD) Service members and their operational
readiness across the world.
Since the outbreak of this novel coronavirus began in the United States, the principal diagnostic
testing regimen utilizes a molecular test prepared by the Centers for Disease Control (CDC). Thishigh complexity assay requires nasal pharyngeal swab collection and transport to a laboratory,
nucleic acid extraction, and subsequent analysis. Sensitive and precise, it detects the presence ofthe virus Ribonucleic Acid (RNA) in the patient, by Real-Time Reverse Transcription Polymerase
Chain Reaction (rRT-PCR). As of April 2020, many other molecular tests have achieved
Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA). The FDA
has issued an EUA for molecular assays, including the Biofire COVID-19 test, and Cepheid's
Xpert Xpress SARS-CoV-2 test—these approvals pave the way for inclusion of COVID-19
diagnostic testing on DoD's Next Generation Diagnostics System (NGDS) family of platforms,
and accelerate the rollout of these testing capabilities across US military installations. Molecular
testing will continue to be critical in the identification and control of COVID-19, in order to protect
the health of the warfighter.
However, there are applications for which these existing molecular diagnostic tools aresuboptimal. While the "Polymerase Chain Reaction" (PCR) detects the presence of RNA, it does
not distinguish between living or dead. The RNA can reside in the body 1-2 months after viralclearance, indicating potential false positive results, if detected by the rRT-PCR test. In situations
when viral RNA is not detectable, molecular diagnostics alone are ineffective for identifying
exposure to SARS-CoV-2. Serological tests (also called antibody tests) may complement
molecular assays in these situations, to enhance diagnostic accuracy, especially late in infection.
Serological assays measure the patient's immune response to an infection. Several days after initialinfection, the body's adaptive immune response begins to produce antibodies. During the initial
response, specific IgA and IgM (Immunoglobulins) molecules begin to circulate. (b) (4)offers protection, particularly for respiratory pathogens that enter through the lungs or (b) (4)membranes. The presence of specific IgM is indicative of an ongoing infection and the body's
attempt to clear the pathogen. In the days following the steep IgM rise, a class switching
recombination to IgG subtypes is observed. The IgG antibodies tend to persist for a longer periodof time and provide immunological "memory" to prevent re-infection. Certain groups of
predominantly IgG antibodies are considered "neutralizing," as these are capable of binding andpreventing viral infection of host cells. This is a novel Coronavirus, and current literature suggeststhat individual titers of immunoglobulins (IgA, IgM, IgG, and neutralizing antibodies) generated
in response to SARS-CoV-2 infection, are highly variable. It is also currently unknown whether
the presence of any of these antibodies confer protection from illness due to re-infection, and if so,
what antibody titers are protective. In spite of these knowledge gaps, COVID-19 antibody tests are
expected to support Force Health Protection by delivering critical information on burden of
infection, disease pathogenesis, asymptomatic infections, basic reproduction number, and theoverall mortality of the COVID-19 among military personnel. Additionally, point-of-care tests
targeting SARS-CoV-2 antigens, or the antibody response, are expected to further support rapid
diagnosis and screening. There is also a need for laboratory based confirmatory serological tests.
This virus is not only spread by those visibly sick, but also by individuals who are not aware theyharbor the virus. In fact, in the state of Washington, the first significant outbreaks in the UnitedStates, more than half of the residents of a Seattle-area nursing home with an early outbreak of
COV1D-19 cases, who tested positive for SARS-CoV-2, were asymptomatic. Of the 76 residentsof the nursing home, 48 (63%) tested positive; of the 48 who tested positive, 27 (56%) wereasymptomatic at the time of testing. 24 residents subsequently developed symptoms with themedian time to symptom onset of 4 days. Specimens from these 24 viral-positive patients who
were pre-symptomatic at testing (71%), had viable virus culture 1 to 6 days before developing
symptoms. Transmission from asymptomatic individuals infected with SARS-CoV-2, most likely
contributed to the rapid and extensive spread of infection to other residents, staff and beyond.
In another example, USS Theodore Roosevelt from March to April 2020, a number of crew
members became infected with COVID-19 during a shore-leave in Vietnam. Subsequently, thevirus spread throughout the ship. From the testing of 4,900 crew (94% tested), 600(12.5%) tested
positive with 360 of those (60%) asymptomatic. This further underscores the threat that this virus
may pose, and accentuates the need to easily and rapidly screen asymptomatic, or those withminimal symptoms of the virus. A further gap is the ability to triage those sick with the normal flu
and COVID-19.
1.2

Scope

Throughout the industry, many have proposed the extensive use of serological, antibody-based
assays. Most antibody tests detect IgG and IgM to determine if a person has previously been
infected with COVID-19, an indication that they've had the virus and now may be immune to thevirus (SARS-CoV-2). They may also be used for contact tracing. Due to commonality between
related viruses, many of these assays target less efficacious sites, which are not specific and do not
determine immunity.

As previously mentioned, the most common assay to detect the virus in nasopharyngeal samples,is the rRT-PCR. The PCR assay, however, requires sophisticated equipment and complex,
expensive test reagents. Additionally, the nasopharyngeal sample is not conducive to selfcollection. A rapid and simple point of care assay which only requires a ( b) (4) sample, which
would offer convenience and ease of use, combined with accuracy, would provide significant
benefit to disease management. The (b ) (4)lassay would allow forcontinuous and simple monitoring, determining presence of SARS-CoV-2, and allowing for thetriage of infected individuals and reduction in the spread of the COVTD-19. This would be a stateof-the-art, rapid COVID-19 Point-of-Care (POC) viral screening assay.
This LFI / Enzyme-Linked Immunosorbent Assay (ELISA) prototype project will provide
diagnostic and detection capability, in order to individually identify the causative agent of the
COVID-19 via ( b) (4)samples and IgA, IgM, and IgGfrom blood and sera, as well as other samples. The proposed diagnostics will have clinicalsensitivity at or greater than 90%, with clinically relevant samples such as ( b) (4) for the LFI, as
well with ELISA using ( b) (4) plasma, serum and others. For COVID-19, the utilization o (b) (4)(b (4 has the potential to detect asymptomatic and symptomatic, including carriers of SARS-CoV2. The utilization of (b) (4) with the LFI assay, allows for the simple POC use. The proposed
diagnostic technology will be ready for pre-submission for FDA EUA clearance, at the conclusionof this project.
Understanding the antibody response to SARS-CoV-2 proteins, may help identify biomarkers thatcan be used to detect and treat COVID-19 infection. However, only limited immuno-peptide
microarray platforms exists that can perform such a broad based proteome-wide analysis.
This prototype Microarray, with multiple antigens targeting many different bindingsites/antibodies on the virus, may be able to track any shifts in the virus, and with multiple
variations on the array. Evolving over time, the pattern of mutation can be identified and detection
and diagnostics strategies, as well as treatments, can be developed with this dynamic screening
process. Currently, Microarrays are focused on the analysis of serum samples targeting IgG and
IgM antibodies. There is currently no effort on the assessment of (b) (4) samples related to tag
Also, there is only limited, if any, focus on (I, in serum within Microarray systems. The NHD
team will provide the only focus based project utilizing the (b) (4) samples with targets related to(b) (4) The selected microarray, both standard and developed, will provide a broad-based approachto understand the mutation of the SARS-CoV-2.
As previously discussed, the most common assay to detect the virus in nasopharyngeal samples,is the rRT-PCR. The PCR assay, however, requires sophisticated equipment and complex,
expensive test reagents. Additionally, the nasopharyngeal sample is not conducive to selfcollection. The state of the art serological assays utilize ELISA, Chemiluminescence, or other moresensitive and specific methods. The rapid and simple point of care assay, which only requires a(b) (4) sample, offers convenience and ease of use, combined with accuracy, would provide
significant benefit to disease management.
Various institutes have developed and produced a new peptide microarray based on the SARSCoV-2 viral genome. These are generally derived from the virus isolate Wuhan-Hu-1 (GenBankID: MN908947.3), and provide the SARS-CoV-2 Proteome Microarray, which gives researchers
access to serologically screen 4,883 individual peptides spanning the entire viral proteome.
However, there remains a need for (b) (4) sample analysis, as well as expansion oftarget sites.
The NHD team will provide Peptide Microarray utilizing the ( b) (4) samples with targets related to2111 The selected microarray, both standard and developed, will provide a select-based approach.
This Microarray prototype project will provide for the expanded capability, in order to individually
identify the active target sites for indicating current and evolving SARS-CoV-2. These peptide
microarrays will focus on antibodies baseditla for ( b) 4
samples. The individual peptide
proteins are printed on solid support, such as glass slides, which are probed with (b) (4) andanalyzed on an imager to detect fluorescence patterns corresponding to SARS-CoV-2
seroreactivity. These arrays capture antibodies present in serum and ( b )14 ) from infectedindividuals, which are semi-quantified using fluorescent secondary antibodies. In this way, acomprehensive profile of targets that result after infection can be determined, that is characteristicof the latest SARS-CoV-2, both current and evolved, and the stage of disease. The differentiallyreactive antigens identified in this way, can be used to develop serodiagnostic and detection tests,
as well as potential treatments and vaccines.
1.3

Objective

The LFI / ELISA prototype project seeks to develop a complementary diagnostic capability, to be
used in conjunction with NGDS, in support of the Warfighter. The capability will be developed
rapidly, in order for its benefits to impact the course of the current outbreak. In accordance with
the Government's request, NHD's proposed diagnostic capability will complement the existing
NGDS family of systems, to improve patient health outcomes and force health decisions, and alignwith JSTO's internal technology development strategy. NHD's development efforts may also
produce reagents that enhance the development or accuracy of these desired diagnostic tests (e.g.
high quality antigens, antibodies, or SARS-CoV-2 antigen assays that may be used at the point-ofcare). The assays need to meet the current standards set by the FDA guidance for EUA for COVID19 assays. These standards are evolving as the Government learns more about humanimmunological responses, and as more diagnostic tests are approved, and the promise and perils
associated with their use is reported. NHD will provide assays for independent validation andverification to a federal laboratory identified by DTRA at the end of phase 1. In phase 2, NHD will
also need to pursue FDA EUA authorization, and be prepared to scale up production of theirdiagnostic assays to meet the anticipated demands.
This is a prototype project because NHD will develop a Point of Care Lateral Flow Assay for
detection of ( b) (4)associated with the COVED-19, to evaluate the technical feasibility ofusing the assay to determine asymptomatic and symptomatic COVID-19 infection, by use of asimple, easy to obtain (b) (4) sample. This assay will allow for the triage of patients, as well as
identify the asymptomatic potential carriers/spreaders of the SARS-CoV-2. This will assist in
maintaining military readiness, control resources, and save lives.
(b) (4)

(b) (4)This assay can be performed at home, work, forward deployed, etc. This is a typicalClinical Laboratory Improvement Amendments (CLIA)-like waived format.
Considering the (b) (4)target is novel, there will be a need for clinical testing of a work-inprocess first generation prototype. After challenged with the actual patient samples, there will bean opportunity for further optimization. After this modification, there will be further testing, nowof the second generation prototype. This is the Go/No-Go point. If successful at detecting, then
expanded testing for EUA submission can be performed. The initial first generation prototype will
be provided after the first 2-3 months of development. Including further development with firstand second generation testing, prior to scale up, the acceptable prototype (after 2nd generation)
may be available after 3-5 months. Further testing in compliance with FDA requirements, as well
as scale-up, will result in as much as 7-8 months of project schedule.
The microarray prototype project seeks to develop a complementary capacity, to be used with othermethods to support the warfighter. The capability will be developed rapidly, in order for its benefits
to monitor any significant mutation or antigen drift with the virus, which may impact the courseof current and future outbreaks. In accordance with the Government's request, NHD's proposed
screening capability will complement the existing NGDS family of systems, to improve patient
health outcomes and force health decisions, and align with JSTO's internal technology
development strategy. NHD's development efforts will select identifying targets on the current
virus, but may also, through the prior project phase, assist in selecting reagents that enhance thedevelopment or accuracy of desired diagnostic tests (e.g. high quality antigens, antibodies, ormutated SARS-CoV-2 antigen/antibody assays). The assays will be a tool to be used to create new
assays or treatments. Although there are no current standards set by the FDA guidance for EUA
for COVID-19 research assays, they will adhere to best practice standards. These standards are
evolving, as the Government learns more about human immunological responses, and as morediagnostic tests are approved, and the promise and perils associated with their use is reported.
NHD will provide assays for independent test development, validation, and verification to a federal
laboratory identified by DTRA.
NHD's proposed peptide assay will be developed as an Antigen Microarray, in which selectproteins derived from the ( b ) (4)and other select sites on the SARS-CoV-2, will be used todevelop peptides which will printed on solid support, such as a glass slide or membrane, in theform of arrays. The individual peptides printed on these arrays, capture antibodies present inserum from infected individuals, which are then quantified using fluorescent secondary antibodies.
Therefore, a comprehensive profile of antibodies that result after infection, can be determined,
which will be helpful to determine the mutation or drift of the SARS-CoV-2. This may ultimately
affect strategies for detection, diagnosis, or treatment, based on the "Old" or original virus. The
differentially reactive antigens identified in this way, can be used to develop detection anddiagnostic tests, or new treatments or vaccines. Initially, current peptide arrays will be evaluatedfor use with the initial viral serum and (b) (4) samples. As the virus mutates, modified peptide
arrays will be developed, which will allow for the determination of mutated key sites on the new
SARS-CoV-2. A total of 450 peptide array will be developed for sample testing.

Organism Peptide Array:
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
Content: Whole proteome of SARS-CoV-2 (GenBank ID: MN908947.3) translated into overlapping peptides.
Tests per Microarray: One (1) array with 4,883 peptides in duplicate.

5ARS-CoV-2 groteome

Infected sera

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0• •••Select peptides for the current SARS-CoV-2 are to be used on a peptide microarray for screening
sera from patients. These arrays would be used at select centers as directed by DTRA (i.e.
Nebraska/other, NHD, Singapore, or other) to periodically screen COVlD-19 patient sera, in orderto determine potential mutation or drift, as an alert to any changes in the virus, which may affectdiagnostics or therapeutics / vaccines, and the medical/epidemiological strategies. Any significant
mutation or drift may trigger NHD to produce revised peptide array slides, which would then be
sent to the filed site(s) for testing and evaluation. This process may continue for several revisionsof the peptide array slides.
The initial first generation peptide microarray prototype, will be provided after the first 2-3 monthsof development. The monitoring of sera at the designated field sites, will commence after
validation of the first generation microarray prototype. Screening will occur every 2-3 months, as
directed by DTRA. NHD will provide necessary microarray slides up to a maximum of 450 total
prototype slides. As a significant drift is reported, NHD will develop a 2'd generation microarray.
This second generation prototype will be made available after 2-3 months, after all information,
including sequences and associated target data, is made available to NHD. The revised prototype
will then be provided to the field for testing and evaluation. Once validated, the revised second
generation peptide microarray prototype, will be provided to the designated field patient sample
screening site for further serum screening, as directed by DTRA. A maximum of 450 total
prototype slides will be provided. This process will continue as necessary, within the budget andschedule of the agreement.
In accordance with 10.U.S.C. §2371b(f), and upon a determination that the prototype project forthis transaction has been successfully completed, this competitively awarded prototype OTA mayresult in the award of a follow-on production contract or transaction, without the use of competitive
procedures. If follow-on production is desired by the Government, LFI / ELISA production would
need to support approximately 20,000 advanced prototypes for testing and evaluation, andsignificant production to support the United States requirements to support the COV1D-19
response, with potentially hundreds of thousands needed. The peptide Microarray production
would need to support approximately 2,000 advanced prototypes for testing and evaluation. This
prototype project will be successfully completed if the contractor meets the key technical goals of
the project, as listed within this document, meets the success metrics established by this agreement
or, at the accomplishment of particularly favorable or unexpected results that justifies transition to
production. The estimated Period of Performance for this effort should not exceed more thantwelve (12) months from the date of award. Additional tasks with periods up to four (4) additional
years, may be added to account for expanded tasks, product scale up, or to maintain a capability
to continuously supply reagents and diagnostics.
If there is a conflict between the Project Agreement and the Base Agreement, the Project
Agreement language will supersede and control the relationship of the parties.
2.0

APPLICABLE REFERENCES

Documents incorporated as part of the requirements, include the current FDA Guidance: "Policy
for Diagnostic Tests for Coronavinus Disease-2019 during the Public Health Emergency," Revised
May 11, 2020.
3.0

REQUIREMENTS

For this prototype project, NB]) will develop FDA-EUA authorized diagnostic lateral flow assays
for the detection of ( b (4)as an indication of COVID-19 infection in clinical (b) (4)samples. A second objective is MID development of a standard ELISA format for detection of
IgA, IgM, and IgG in blood and sera for a serological assay, for an indication of exposure andpotential protection. Additionally, NHD will work to allow for detecting these targets in otherclinical samples, as a potential field standard method.
3.1

LFI / ELISA Development (Phase 1)

Project Tasks and Risk 1. NHD shall develop a lateral flow assay for the (b) (4)from b) (4) samples.

Technical Task: (a) NHD shall optimize
antibody detection in a lateral flow assay; Final lateral flow assay for IgA related targets directfrom (b) (4) sample.
Risk: The (b) (4)antigens are available, and the initial (b) (4)has been utilized in a prototype serological assay. Several =(b) (4)antibodies are available commercially. One of these antibodies has been utilized in serologicalassay. Conversely, if (b) (4)antibodies are needed, the (b) (4) has also been utilized in alateral flow format. Other antibodies are also available. The various formats will be included in
the first generation prototype testing, in order to determine the more sensitive and specific format
selected for optimization.
2. NT-[D shall test and demonstrate clinical (b) (4) matrixes are suitable for the detection ofin the diagnosis of COVID-19 in a lateral flow assay developed in objective 1.
Technical Tasks: (a) NHD shall use the lateral flow assay to detect clinically relevant
concentrations o. (b) (4)samples.
Risk: The (b) (4) Matrix will not meet detection requirements. Risk for (b) (4)is low,as there are commercially available (b) (4) collection kits, and there is significant 3rd party data
supporting performance o (b) (4) as sample for (b) (4)(b) NHD shall execute appropriate clinical trials of the El lateral flow assay for COVID-19
diagnosis.
Risk: Lateral Flow Inununoassay will not meet requirements. The clinical trials will not be initiatedunless parameters are met in the lab testing, and after the first generation prototype provides atleast minimally acceptable results, in terms of detection. Historical experience with clinicalsamples with the LFI, minimizes overall risk.
3. NHD shall develop an ELISA test with antigens and antibodies against IgA, IgM, and IgG
for the determination of immune response to the COVID-19 in whole blood, as well as
detection of the targets in other samples.
Technical Task: (a) NHD shall develop an ELISA test for IgA, IgM, and IgG antibodies in sera or
blood, with high specificity and sensitivity.
Risk: The ELISA is not sufficient or sensitive to detect the specific IgA, IgM, and IgG antibodies.
The ELISA format is well-known and the antigens from (b) (4) have been evaluated in other formats
with acceptable results. Other antigens and antibodies are commercially available.
4. NHD shall execute appropriate clinical trials of the ELISA for IgA, IgM, and IgG for
determination of exposure to COVID-19 in sera.
Risk: The ELISA format provides for unacceptable performance in development of assay, andwould prevent clinical trials. Risk as stated above, is minimal. The assay will be evaluated during
the first generation prototype testing.
Project Technical Tasks Summary 1. NHD shall optimize antigens (b) (4)and antibod (b) (4) complex for LFI and IgA, IgM,
and IgG for the ELISA format for the COVID-19. (NHD will determine the optimum antigens andantibodies)2. NHD shall optimize the lateral flow assay for related antigens (b) (4)and antibodies forin buffer and simulated samples, and IgA, IgM, and IgG in ELISA. (NHD will transfer
optimized antigens and antibodies in the formats)(bi

3. NHD shall use the lateral flow assay and ELISA to detect clinically relevant concentrations oftargets in buffer, simulated sample, whole blood samples or serum samples. (NHD willconcurrently evaluate COTS ( b ) (4) collection kits)
4. NHD shall conduct a field trial of the lateral flow assay (separate LFI for (b) (4)) and
ELISA IgA, IgM, and IgG for COVID-19 diagnosis/detection. (NHD will conduct appropriate
clinical sample testing of first generation prototypes)
5. NHD shall optimize Lateral flow Immunoassay for the detection of (b) (4)IgA, IgM, and IgG for high specificity and sensitivity.

and ELISA

6.MAD shall use the lateral flow assay to detect clinically relevant concentrations o (b) (4)samples and ELISA format to detect IgA, IgM, and IgG in sera and other samples. (NHD willconduct appropriate clinical sample testing of second generation prototypes)
7.NHD shall conduct bench testing of the lateral flow assay for
IgG.

) and ELISA for IgA, IgM, and

8. MID shall conduct all activities to execute scale-up of the LFI and ELISA systems.
9. NI-ID shall conduct all activities required for submission of EUA of the LFIELISA IgA, IgM, and IgG in sera , as well as other samples for COVID-19.
Technical Strategy and Innovations 1. Demonstrate and test clinical b ) (4) matrixes suitable for detection of (b) (4)diagnosis of COVID-19 with the lateral flow assay developed in objective 1.

, for theTechnical Solution: The (b) (4) sample matrixes will be tested as the clinical samples to apply tothe assay. If necessary, a (b) (4)agent may be added to enhance presentation of the(bH) to theassay, and provide improved assay performance.
2. The LFI and ELISA require improved sensitivity and specificity.
Technical Solution: Review available (b) (4)as well as b) fl antibodies from the b) (4) andother sources. Additionally, engage the use of ( b) (4)3. Improved sensitivity of LFI (b) (4)Technical Solution: NHD Standard Operating Procedures (SOP) will be used to (b) (4)(b) (4)4. Improved binding and "clean results" (b) (4(Technical Solution: Using NI-ID SOP (b) (4)Mandatory Reporting Quarterly Reports: The MCDC awardee shall prepare a Quarterly Report, which will include aTechnical Status Report and a Business Status Report, in accordance with the terms and conditionsof the MCDC Base Agreement.
Annual Technical Report: The MCDC awardee shall prepare an Annual Technical Report for
projects whose periods of performances are greater than one (1) year, in accordance with the terms
and conditions of the MCDC Base Agreement. This may be combined with the concurrent
quarterly report.
Final Technical Report: At the completion of the project, the MCDC awardee will submit a Final
Technical Report, which will provide a comprehensive, cumulative, and substantive summary of
the progress and significant accomplishments achieved during the total period of the project, in
accordance with the terms and conditions of the MCDC Base Agreement. Once the MCDC
management firm has informed the MCDC awardee that the Final Technical Report has been
approved by the Government, the MCDC awardee shall forward a copy to the Defense Technical
Information Center, Attn. DTIC-0, 8725 John J. Kingman Road, Suite 0944, Fort Belvoir, VA
22060-6218.
Final Business Status Report: At the completion of the project, the MCDC awardee will submit
a Final Business Status Report, which will provide summarized details of the resource status of
the project, in accordance with the terms and conditions of the MCDC Base Agreement.
Project Task Timeframe:

Task
etc..
1 Assa Desig • ( b) (4)FDA EUA Preparation
Preliminary Design Review
2 Antigen and Antibody Chemistries Development:
COVED-19 Antigen Prototype Optimization
COVED-19 Antibody Prototype Optimization
3 Assay and Sample Conditions: (can be concurrent with #s 1 & 2)
Positive and Negative Controls Development

Timeframe
2-4 weeks

4-6 weeks

2-4 weeks

4
5
6
7
8
9
10
11

First Generation Prototype Field Testing: (PCR, ELISA, Serological, &(.) (4)
Optimize for Clinical Matrices
Optimization of Device, Combining Chemistries into Assay System
Bench Studies Meeting/Protocols Development
Second Generation Prototype Testing and Revision
Conduct Bench-Field Studies
Production Scale up, Stability, Additional Analytical Testing
Develop and Submit Bench Studies Reports
FDA EUAFDA EUA Approval Phase Support
Prototype Project Management and Reporting
FDA, Microbiology, and (b) (4)Consultant Support
Quality Control Inspection, Testing, and Monitoring
Total Period of Performance:

2-3 weeks
1-3 weeks
2-4 weeks
3-4 weeks
4-8 weeks
35 weeks
35 weeks
35 weeks
35 weeks

Project Deliverable Tasks
Del. #

Deliverable Description

3.1
3.2
3.3
3.4
3.5
3.6
3.7
3.8
3.9
3.10
3.11
3.12
3.13

FDA EUA Meeting Minutes
Preliminary Design Specifications for LFI / ELISA
Preliminary Design Review Meeting Minutes
Draft Package Insert
First Prototype Pre-Clinical Testing Study Report
Risk Analysis Master Record
Second Prototype Selection Meeting Minutes
Design Transfer Meeting Minutes
Bench Study Meeting Minutes
Bench Study Protocols
Clinical Study Meeting Minutes
Design Verification Meeting Minutes
Monthly/Quarterly Progress and Financial Status Reports

3.14

Final Closeout Report - Due 30 days after Completion ofEffortDraft Device Master Record
Device History Record for Three (3) Lots
Final Bench Study Protocols
Limit of Detection/Matrix Comparison
Bench Study Reports
Final Clinical Study Protocol
Second Prototype Clinical Study

3.15
3.16
3.17
3.18
3.19
3.20
3.21
3.2

Peptide Microarray Development (Phase 2)

Due
Date
6/15/2020
6/30/2020
6/30/2020
7/31/2020
8/31/2020
8/31/2020
9/30/2020
9/30/2020
8/31/2020
8/31/2020
8/31/2020
9/30/2020
6/30/2020 12/31/2020
1/31/2021
10/31/2020
12/31/2020
10/31/2020
10/31/2020
9/30/2020
10/31/2020
10/31/2020

Project Tasks and Risk 1. NHD shall review current Microarrays for COVID -19, and if needed, develop additional
Peptide Antigen Microarrays for SARS-CoV-2, binding targets from (b ) (4)samples, which would indicate patient type specific antibodies that bind to specific SARSCoV-2 linear epitopes, correlating this information with patient clinical and viral status,
and thereby characterizing (b ) (4) patterns with COVID-19 disease.
2. For drift or significant mutation change analyses, not single point mutations, sequencing
may be required with supercomputing bio-informatic processing software, in order todelineate specific mutations and consequent antigenic drift occurrence.
Technical Task: NHD shall obtain selected, optimized, and printed peptides on microarrays
consistent with linear epitopic binding areas of the current SARS-CoV-2 RNA encoded genome;
to be used in an appropriate instrument within a SARS-CoV-2 peptide Antigen Microarray system.
The final peptide Antigen Microarray will be for defining specific targets from COV1D-19
individual patients' samples. These will include isotype and (b) (4) and targets of

Es

Risk: The selected peptides will not bind with the needed targeted sites, with sufficient binding toprovide acceptable performance in samples. These peptides will be included in the first generation
prototype microarray system.
3. NHD shall test and demonstrate that clinical sample (b ) (4) matrixes are suitable for theidentification of the needed binding targets, and correlate that with sera targets in a Peptide
Antigen Microarray developed in objective 1.
Technical Task: (a) MID shall use the Peptide Antigen Microarrays to detect clinically relevantbinding targets, and determine defining patterns of patients' antibody to the SARS-CoV-2 peptides
present in (b) (4)samples. Also, as needed, data in serum ,b)samples, to provide
information to correlate with (b ) (4) patterns.
Risk: The peptide microarray will not meet specificity and detection requirements.
Technical Task: (b) There is a risk that the peptide array may not be sufficiently reproducible inthe binding or broadly encompassing, since it lacks conformational epitopes to identify all needed
targets/markers. The NHD team, through genomic and previous viral mutation expertise, will
modify peptide arrays to address specificity and detection requirements, focusing on peptides
indicative of significant mutational changes, as opposed to single point mutation events.
Project Technical Tasks Summary —1. NHD shall conduct initial prototype design and testing/monitoring protocol with ELISA andother toolsm if needed, utilizing technologies developed within the initial prototype project phase.
2. NHD shall determine selected linear targets on the SARS-CoV-2 RNA encoded peptides, andselect/produce linear peptides of the entire viral-encoded genome.

3. NHD shall select microarray slide producer and subcontract for supply, as well as sample virus
inactivation protocols.
4. NHD shall select/lease microarray readers and equipment.
5. NHD shall perform verification of initial prototype arrays in NHD.
6. NHD shall perform verification studies of initial prototype arrays at other site(s).
7. NHD shall produce/supply microarray slides to other site(s) for monitoring, as per monitoring
protocol.
8. NHD shall perform field screening of (b) (4) & serum with initial microanays.
9. NHD shall review data/information, as per protocol.
10.NHD shall modify target peptides, based upon data/information from on-going monitoring.
11.NHD shall produce revised second peptide microarray slides.
12.NHD shall perform verification studies in NHD of revised peptide microarray slides.
13.NHD shall supply revised peptide microarray slides to field users for verification and use.
14. NHD shall review data/information, as per protocol / prepare additional slides peptide
microarray for field use.
15.NHD shall provide data/information to other agencies, as required.
Project Task Timeframe:

1
2
3
4
5
6
7
8
9
10
11

Task
Initial Prototype Design and Testing/Monitoring Protocol with ELISA andOther Tools (if needed)
Determine Targets on the SARS-CoV-2 and Select/Produce Peptides
Select Microuray Readers and Equipment
Preliminary Design Review
Perform Verification Studies in NHD
Perform Verification Studies at Other Site(s)Produce/Supply Microairay Slides to Other Site(s) for Monitoring (as permonitoring protocol)
Perform Field Screening ofand Serum with Initial Microan-ays
Review Data/Information (as per protocol)
Modify Target Peptides Based Upon Data/hifonnation from On-Going
Monitoring
Produce Revised Second Prototype Peptide Microarray Slides

Timeframe
2-4 weeks
2-4 weeks
2-4 weeks
4-8 weeks
6-10 weeks
9-12 weeks
12-15 weeks
16-28 weeks
24-30 weeks
30-32 weeks
33-35 weeks

12 Perfonn Verification Studies in NHD of Revised Peptide Microarray Slides
Supply Revised Peptide Microarray Slides to Field Users for Verification
13 and Use
Review Data/Information (as per protocol)/Prepare Additional Slides
14 Peptide Microarray for Field Use
Prepare, Evaluate, and Supply Modified Microarrays (as needed, based upon
15 mutations)
16 Provide Data/Information to Other Agencies (as required (continuous))
17 Prepare Final Reports
Total Period of Performance:

36-37 weeks
38-45 weeks
44-46 weeks
46-51 weeks
24-51 weeks
51-52 weeks
52 weeks

Project Deliverable Tasks
Del. #
3.1
3.2
3.3
3.4
3.5
3.6
3.7
3.8
3.9
3.10
3.11
3.12
3.13
3.14
3.15
3.16
3.17

4.0

Deliverable Description

Due
Date
7/31/2020

Initial Prototype Design and Testing / Monitoring Protocol with
ELISA and Other Tools (if needed)
Determine Targets on the SARS-CoV-2 and Select/Produce Peptides
7/31/2020
Select Microarray Readers and Equipment
7/31/2020
Preliminary Design Review
8/31/2020
Perform Verification Studies in NH])
9/30/2020
Perform Verification Studies at Other Site(s)9/30/2020
Produce/Supply Microarray Slides to Other Site(s) for Monitoring (as 10/31/2020
per monitoring protocol)
Perform Field Screening of (b) , ) and Serum with Initial Microarrays 11/30/20201/31/2021=
Review Data/Information (as per protocol)
2/28/2021
Modify Target Peptides Based Upon Data/Information from On3/31/2021
Going Monitoring
Produce Revised Second Prototype Peptide Microarray Slides
4/30/2021
Perform Verification Studies in NHD of Revised Peptide Microarray
4/30/2021
SlidesSupply Revised Peptide Microarray Slides to Field Users for
5/31/2021
Verification and Use
Review Data/Information (as per protocol) / Prepare Additional Slides 5/31/2021
Peptide Microarray for Field Use
Prepare, Evaluate, and Supply Modified Microarrays (as needed,
5/31/2021
based upon mutations)
Provide Data/Information to Other Agencies (as required
5/31/2021(continuous))
Prepare Monthly/Quarterly Progress and Final Reports
7/31/20206/31/2021
DELIVERABLES

4.0

LFI / ELISA (Phase 1) and Peptide Microarray (Phase 2)

Del. #

PHASE

1.0.1

1

4.0.2

1

4.0.3

1

4.0.4

1, 2

4.0.5

2

4.0.6

1

4.0.7

2

4.0.8

2

4.0.9

2

4.0. 1014.0. 1 1

1

Deliverable
Description
FDA EUAmeeting minutes
Preliminary design
specifications for
LFI/ELISA
Preliminary design
review meeting
minutesMonthly/Quarterly
progress annual
and financial status
reports

SOW Meeting
Minutes
Draft package
insert LFIInitial prototype
design andtesting/monitoring
protocol with
ELISA and othertools, if needed
Determine targets
on the SARSCoV-2 andselect/produce
peptidesSelect microarray
readers andequipment
First prototype
pre-clinical testing& study report
LFI/ELISA
Initial master

Due
Date

Milestone Ref

6/15/2020 ' 5.0.1

SO
W
Ref
3.1

Gov't
Role

Data
Rights

Review/
Comment
Review/
Comment

Govt
purposeGovt
purpose

6/30/2020

5.0.2

3.1

6/30/2020

5.0.2

3.1

Review/
Approve

Govt
purpose

6/30/202012/31/2020

3.1
3.2

Review/
Approve

Govt
purpose7/15/2020

5.0.3,
5.0.6,
5.0.10,5.0.14,5.0.18,5.0.225.0.105.0.4

3.2

7/31/2020

5.0.5

3.1

7/31/2020

5.0.4

3.2

Review/
Comment
Review/
Comment
Review/
Comment

Govt
purposeGovt
purposeGovt
purpose

7/31/2020

5.0.7

3.2

Review/
Comment

Govt
purpose

7/31/2020

5.0.7

3.2

Review/
Approve

Govt
purpose

8/31/2020

5.0.9

3.1

Review/
Comment

Govt
purpose

8/31/2020

5.0.9

3.1

Review/Govt

4.0.121

4.0.131

4.0.141

4.0.152

4.0.161

4.0.171

4.0.181

4.0.191

4.0.202

4.0.212

4.0.221

4.0.231

4.0.241

4.0.25

1

Device record
LFI/ELISA
Bench study
meeting minutes
LFI/ELISA
Bench study
protocols
LFI/ELISA
Clinical study
meeting minutes
LFI/ELISA
Preliminary design
review
Second prototype
selection meeting
minutes
LFI/ELISA
Design Review
meeting minutes
LFI/ELISA
Design verification
meeting minutes
Bench study
reports
LFI/ELISA
Perform
verification studies
in NHD
Microarray
Perform
verification studies
at other site(s)Microarray
Updated Device
master record
Final bench study
protocols
LFI/ELISA
Limit ofdetection/matrix
comparison
LFI/ELISA
Updated clinicalComment

purpose

8/31/2020

5.0.9

3.1

Review/
Comment

Govt
purpose

8/31/2020

5.0.9

3.1

Review/
Comment

Govt
purpose

8/31/2020

5.0.9

3.1

Review/
Comment

Govt
purpose

8/31/2020

5.0.11

3.2

9/30/2020

5.0.13

3.1

Review/
Comment
Review/
Approve

Govt
purposeGovt
purpose9/30/2020

5.0.13

3.1

Review/
Comment

Govt
purpose9/30/2020

5.0.13

3.1

Limited9/30/2020

5.8

3.1

Review/
Comment
Review/
Comment

Govt
purpose9/30/2020

5.0.15

3.2

Review/
Comment

Govt
purpose9/30/2020

5.0.15

3.2

Review/
Comment

Govt
purpose

10/31/2020

5.10

3.1

Limited10/31/2020

5.10

3.1

Review/
Comment
Review/
Comment

10/31/2020

5.10

3.1

Review/
Comment

Govt
purpose

10/31/2020

5.10

3.1

Review/

Govt

Govt
purpose4.0.261

4.0.272

4.0.282

4.0.291

4.0.301

4.0.312

4.0.322

4.0.332

4.0.342

4.0.352

study protocol
Second generation
clinical study
Produce/supply
microarray slides
to other site(s) for
monitoring, as permonitoring
protocolPerform field
screening of (b ) (4)and serum withinitial microarrays

Comment
Review/
Comment
Review/
Approve

putposeGovt
purposeGovt
purpose

10/31/2020

5.10

3.1

10/31/2020

5.0.193.2

11/30/2 020
12/31/2020

5.0.19

3.2

Review/
Comment

Govt
purpose12/31/2020

5.16

3.1

Review/
Comment

Limited6/30/2021

5.16

3.1

Review/
Approve

Govt
purpose

2/28/2021

5.0.15

3.2

Review/
Comment

Govt
purpose

3/31/2021

5.0.15

3.2

Review/
Comment

Govt
purpose

4/30/2021

5.0.15

3.2

Review/
Comment

Govt
purpose

4/30/2021

5.0.19

3.2

Review/
Comment

Limited5/31/2021

5.0.38,,

3.2

Review/
Approve

Govt
purposeGM
Device history
record for three (3)lots LFJJELISA
Final closeout
report - due 30
days after
completion ofeffortReview
data/information,as per protocol
Modify target
peptides based
upondata/informationfrom on-going
monitoring
Produce revised
second protype
peptide microarrayslidesPerform
verification studies
in NHD of revised
peptide microarrayslidesSupply revised
peptide microarrayslides to field users

4.0.362

4.0.372

4.0.382for verification anduse
5/31/2021
Review
data/information.
as perprotocol/prepare
additional slides
peptide microarrayfor field use
5/31/2021
Prepare, evaluate
and supply
modifiedmicroarrays, as
needed, based
upon mutations
5/31/2021
Providedata/information toother agencies, as
required(continuous)

5.0.32

3.2

Review/
Approve

Govt
ptupose5.0.23

3.2

Review/
Comment

Limited5.0.32

3.2

Review/
Comment

Limited

5.0

MILESTONE PAYMENT SCHEDULE

5.0

LFI / ELISA (Phase 1) and Peptide Microarray (Phase 2)

Milestone

Phase

Task
#

Milestone Desuiption( Deliverable Reference)

5.0.1

1

3.1

FDA EUA Discussions, Initial Team
Teleconference, FDA EUA
Teleconference Meeting Minutes;
Deliverable 4.0.1
Initial LFI Prototype, Initial ELISA
Prototype, Design Specifications;
Deliverable 4.0.2
Preliminary Design Review Meeting
Minutes; Deliverable 4.0.3
Quarterly Report; Deliverable 4.0.4
SOW Meeting Minutes; Deliverable 4.0.5

5.0.2

5.0.3
5.0.4

1

1
-,_

3.2
3.3

3.0

Due Date

Total
Prouramt,
Funds

6/15/2020(b) (4)

6/30/2020
6/30/2020
7/15/2020

5.0.5

1

3.2
3.3

Optimintion Data, Revised Design
Specifications, Revised Design Plan,
Initial Positive/Negative Controls, Initial
Clinical Matrices, Initial Draft Package
Inserts; Deliverable 4.0.6

7/31/2020i(b) (4)(b) (4).

ili5.0.6

1, 2

5.0.7

2

5.0.8

5.0.9

1

3.1
3.2
3.3

3.5
3.3

I. ")

Monthly Report; Deliverable 4.0.4

7/31/2020

Initial Prototype Design andTesting/Monitoring Protocol with ELISA
and Other Tools (if needed); Deliverable
4.0.7
Determine Targets on the SARS-CoV-2
and Select/Produce Peptides; Deliverable
4.0.8
Select Microarray Readers andEquipment; Deliverable 4.0.9

7/31/2020

Bench Study Meeting Minutes;
Deliverable 4.0.12
Bench Study Protocols; Deliverable 4.10
Optimize for Clinical Matrices;
Deliverable 4.11 First Prototype PreClinical Testing, Revised Draft Package
Insert, Initiate Bench Study Reports;
Deliverable 4.5
Risk Analysis Master Record; Deliverable
4.0.11Monthly Report; Deliverable 4.0.4

5.0.11

5.0.12

i

1

3.4

3.5
3.3

I. "'

Preliminary Design Review Minutes;
Deliverable 4.0.15
Remaining Bench Study Reports;
Deliverable 4.0.19
Prototype Selection Meeting Minutes:
Deliverable 4.0.16.
Design Transfer Meeting Minutes;
Deliverable 4.0.17
SOPs, Design Verification Meeting
Minutes; Deliverable 4.0.18
Annual Report; Deliverable 4.0.4

II.

8/31/2020
8/31/2020

5.0.10(b) (4)(b) (4)

8/31/2020

It

9/30/2020(b) (4)9/30/2020

5.0.135.0.14

2

1

3.5
3.6

3.5
3.4
3.3

Perform Verification Studies in NHD;
Deliverable 4.0.20
Perform Verification Studies at Other
Site(s); Deliverable 4.0.21

9/30/2020

ii

Operator Training, Training AAR, Initiate
FDA EUA Phase, Device Master Record;
Deliverable 4.0.22

10/31/2020

I.

3.2

5.0.151, 2Final Bench Study Protocols; Deliverable
4.0.23
Limit of Detection/Matrix Comparison;
Deliverable 4.0.24
Final Clinical Study Protocol; Deliverable
4.0.25
Clinical Study Report; Deliverable 4.0.26, Lot 1 - Initiate Production of 1,000 LFIDevices/100 ELISA Devices, Second Gen
Clinical Study; 4.0.26
Monthly Report; Deliverable 4.0.4
10/31/2020-3 0 16-,_

5.0.171

5.0.18

1

3.7

3.6

3.3

Produce/Supply Microarray Slides to
Other Site(s) for Monitoring (as permonitoring protocol); Deliverable 4.0.27
Lot 2 - Initiate Production of 1,000 LFIDevices/100 ELISA Devices, Deliver
1,000 LEE Devices/100 ELISA Devices
Monthly Report; Deliverable 4.0.4

10/31/2020

11/30/2020
11/30/2020

5.0.195 0 '(1)5.0.21

2

1
1. 2

3.8

3.6
3.8

Perform Field Screening o ( b) 14) and
Serum with Initial Microarrays VER
Deliverable 4.0..8
Lot 3 - Initiate Production of 1,000 LEE
Devices/100 ELISA Devices
Quarterly Report; Deliverable 4.0.4

5.0.23

-,_

1. 2

3.8

3.6
3.7
3.8

Perform Field Screening o (b) (4) and
Serum with Initial Microarrays 1(b) (4)Deliverable 4.0.28

1

3.6

3.7

(1) (4)11

12/31/2020

ill
(b) 4

12/31/2020

a

1 LFI/ELISA FDA; Closeout Report

Microarry Monthly Report; Deliverable
4.0.29, 4.0.30, 4.0.28, 4.0.4
1/31/2021

5 021

I.

11/30/2020

12/31/2020-3 0 22. 4

FDA EUA Submission Package, FDA
Comments, FDA Response Document,
Device History Record; Deliverable
4.0.29Closeout Report; Deliverable 4.0.30

1/31/2021(b) (4)i5.0.252

5.0.26
5.0.272
2

5.0.285.0.292
2

5.0.305.0.31

2
2

5.0.325.0.331_'

5.0.345.0.35

2
2

3.8

3.9

3.10

3.11
3.12

3.13
3.14
3.15
3.16

3.17

Perform Field Screening o c b) 4) and
Serum with Initial Microarrays CM
Deliverable 4.0.28
1/31/2021
Monthly Report; Deliverable 4.0.4
1/31/2021
Review Data/Information (as per
protocol); Deliverable 4.0.31
2/28/2021
Monthly Report; Deliverable 4.0.4
2/28/2021
Modify Target Peptides Based Upon
Data/Information from On-Going
Monitoring; 4.2.10
3/31/2021
Quarterly Report; Deliverable 4.0.32
3/31/2021
Produce Revised Second Prototype
Peptide Microarray Slides; Deliverable
4.0.33
Perform Verification Studies in NHD of
Revised Peptide Microarray Slides;
Deliverable 4.0.34
4/30/2021
Monthly Report; Deliverable 4.0.4
4/30/2021
Supply Revised Peptide Microarray Slides
to Field Users for Verification and Use;
Deliverable 4.0.35
Review Data/Information (as per
protocol)/Prepare Additional Slides
Peptide Microarray for Field Use;
Deliverable 4.0.36
Prepare, Evaluate, and Supply Modified
Microarrays (as needed, based uponmutations); Deliverable 4.0.37
Provide Data/Information to Other
Agencies (as required) (continuous);
Deliverable 4.0.38
5/31/2021
Monthly Report; Deliverable 4.0.4
5/31/2021
Closeout/Final Report; Deliverable 4.0.4
6/30/2021
Total Cost (FFP):
Period of Performance:

•

N

N
it)41

i b) ( 41( b) (4)S2,909,759
13 Months*The Due Dates and Funding Amounts listed in this Milestone Schedule are contingent upon funds
available. In accordance with Section 5, Incremental Funding, this Project Agreement is funded at
the amount specified, and any work performed in excess thereof shall be at the Project Agreement
Holder's risk.
6.0
SHIPPING PROVISIONSThe contractor shall submit Quarterly, Annual, and final reports in accordance with the Base
Agreement to deliverables.mcdc.ati.org. All deliverables intended for the AOR shall be deliveredin electronic format to the AOR and alternate AOR, as identified within this document.

A copy of all data deliverables shall be sent to:
1

1

1

1

1

.

1

I•

1

I

usarmy.aetricx.aoa-ipeo-coma.mnx.otaaenverame(a)mail.inii

7.0

DATA RIGHTS AND COPYRIGHTS

The contractor shall comply with the terms and conditions defined in the MCDC Base Agreement.
The table below identifies pre-existing technical data and computer software with restrictions that
may be used during performance of this Agreement. The Government shall receive a Government
Purpose Rights license to all technical data and computer software developed and delivered under
this Agreement, except for the pre-existing technical data and computer software that waspreviously developed exclusively at private expense and identified in the table below. To the
maximum extent practicable, segregable portions of deliverables that will be restricted shall beclearly identified and labeled. If, after award, the contractor wishes to use any other internallydeveloped technical data or computer software, or any other pre-existing proprietary information
not identified in the table below, then the contractor shall disclose its intent in writing to the MCDCCMF prior to its use, and shall receive written approval from the Agreements Officer prior toproceeding. All technical data and computer software developed or delivered under this Agreement
shall have appropriate data rights markings in accordance with DFARS 252.227-7013(f) and7014(0. The contractor asserts that all contractor owned or background patents that affect theGovernment's rights in the deliverables anticipated under this Agreement are identified in the tablebelow.
Technical Data to be
Furnished with
Restrictions
Assay production
methods

arMillName ofCorporation
AssertingRestrictions
Developed at Limited rights NHD Corp.
privateexpenseDeliverables
Affected

Developed at
privateexpense3.2, 3.3, 3.4,
3.4.4, 3.5,
3.6, 3.7, 3.8

Basis for
Assertion

Asserted
RightsCategory

Limited rights NHD Corp.

Use of b) ( ) for
Developed at Limited rights NHD Corp.
detection ofprivateCovid-19 expense(b)(4)

7.1

Government Rights

The Project Agreement Holder (PAH) agrees to the following:

3.2, 3.3, 3.4,
3.4.4, 3.5,
3.6, 3.7, 3.8

All

a. The PAH will provide to the Government all data including top-line summaries and key
conclusions from all studies supporting the regulatory filing and commercial approval to the extent
that such data, summaries, and conclusions are funded by this agreement. In addition, the PAH
will offer the Government the opportunity to review and provide comments on a final draft ofregulatory submissions which include data funded by this agreement. The Government will review
any such submissions promptly upon receipt. The PAH will reasonably consider any comments
provided by the Government, and prior to submission will provide notification to the Governmentof any additional edits or revisions. The PAH will keep the Government apprised of planned FDA
meetings and post-meeting outcomes relating to activities funded by this agreement.
b. Communications. PAH will provide the Government with copies of all communications, bothformal and informal, to or from FDA, regarding the Technology within 48 hours, and ensure that
the Government representatives are invited to participate in any formal or informal Sponsor
meetings with FDA;
c. Non-compliance with section (a. & b.) may result in termination of the agreement.
d. Product Development Failure. Certain product development failures may trigger certain
remedies in Section "e." below for the Government advanced developer funding the developmentof this Technology. This remedy is not available to the Government for any cause outside of thefollowing:(i) if this agreement is terminated for nonperformance,(ii) the PAH fails to obtain FDA approval within the operationally relevant timeframe
determined by the Government after the award of this agreement (e.g., 3 years), when FDA
approval is a requirement;(iii) the PAH fails to commercially market or provide an acceptable life cycle plan for continued
supply of the Technology within three (3) years after FDA approval, licensure or clearance;(iv) the PAH gives notice, required to be submitted to the Government no later than thirty (30)business days, of any formal management decision to terminate this product development effort
pre-market or to file for Federal bankruptcy protection.
e. If any of the product development failures listed in Section "d." occur, the PAH, upon the requestof the Government:(i) shall transfer possession, ownership and sponsorship or holdership of any Regulatory
Application (including any associated expedited review designation, priority review voucher, or
marketing exclusivity eligibility or award), regulatory correspondence, and supporting regulatory
information related to the Technology, to the Government or its designee;(ii) shall inform FDA of the transfer of sponsorship or holdership of the Regulatory Applicationtransferred under section (e)(i) above;

(iii) shall negotiate in good faith a non-exclusive license, at customary industry rates and underreasonable terms and conditions, to any patent, copyright or other intellectual property owned orcontrolled by the PAH, developed prior to or outside the scope of this agreement, or any technicaldata that is necessary for the Government to pursue commercialization of this technology with athird party for sale to the Government or otherwise.
f. This clause will survive the acquisition or merger of the PAH by or with a third party. Thisclause will also be included in any subcontracts/sub-agreements relating to the development of theTechnology. This clause will survive the expiration of this agreement.
8.0

SECURITY

The security classification level for this effort is UNCLASSIFIED. The contractor shall comply
with the terms and conditions defined in the MCDC Base Agreement, as applicable.
9.0

MISCELLANEOUS REQUIREMENTS (SAFETY, ENVIRONMENTAL, ETC.)

N/A
10.0
N/A

GOVERNMENT FURNISHED PROPERTY/MATERIAL/INFORMATION