1. THIS CONTRACT IS A RATED ORDER
UNDER DPAS (15 CFR 700)

AWARD/CONTRACT

PAGE OF PAGESRATING

2. CONTRACT (Proc. Inst. Ident.) NO.

3. EFFECTIVE DATEHHSO100201800016C

81

1

4. REQUISITION/PURCHASE REQUEST/PROJECT NO.

See Block 20C OS221221

5. ISSUED BY

ASPR-BARDA

CODE

6. ADMINISTERED BY (If other than Item 5)

ASPR-BARDA
200 Independence Ave., S.W.
Room 640-G
Washington DC 20201

CODE

ASPR-BARDA02

US DEPT OF HEALTH & HUMAN SERVICESASST SEC OF PREPAREDNESS & RESPONSE
ACQ MANAGEMENT, CONTRACTS, & GRANTSO'NEILL HOUSE OFFICE BUILDING
Washington DC 20515

7. NAME AND ADDRESS OF CONTRACTOR (No., Street, City, Country, State and ZIP Code)

8. DELIVERYX

FOB ORIGIN

OTHER (See below)

9. DISCOUNT FOR PROMPT PAYMENT

10. SUBMIT NVOICES(4 copies unless otherwise specified)
TO THE ADDRESS SHOWN N
CODE

ITEM

FAC LITY CODE

11. SHIP TO/MARK FOR

CODE

12. PAYMENT WILL BE MADE BY

HHS/OS/ASPR

HHS/OS/ASPR
200 C St SW
WASHINGTON DC 20201

CODE

ASPR/BARDA01

ASPR/BARDA01
200 C St SW
Washington DC 20201

13. AUTHORITY FOR US NG OTHER THAN FULL AND OPEN COMPETITION:
10 U.S.C. 2304 (c) ()

15A. ITEM NO

14. ACCOUNTING AND APPROPRIATION DATA

41 U.S.C. 253 (c) (2018.199TWNQ.25106)

15B. SUPPLIES/SERVICES

15C.
15D.
QUANTITY UNIT

15E. UNIT PRICE

15F. AMOUNTContinued$14,000,000.00

15G. TOTAL AMOUNT OF CONTRACT
16. TABLE OF CONTENTS

(X)

SEC.

DESCR PTION

PAGE(S)

(X)

1
3
10
18
19
20
33
39

X

PART I - THE SCHEDULE

SEC.

PAGE(S)DESCR PTIONPART II - CONTRACT CLAUSESXASOLICITATION/CONTRACT FORMX

B

SUPPLIES OR SERVICES AND PRICES/COSTSXCDESCR PTION/SPECS./WORK STATEMENTX

D

PACKAGING AND MARKINGXE

INSPECTION AND ACCEPTANCE

XF

DELIVER ES OR PERFORMANCEX

G

CONTRACT ADM NISTRATION DATAX

H

SPECIAL CONTRACT REQUIREMENTS

I

48

CONTRACT CLAUSESPART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.
X

J

53

LIST OF ATTACHMENTS

PART IV - REPRESENTATIONS AND NSTRUCTIONSK

REPRESENTATIONS CERTIFICATIONS AND
OTHER STATEMENTS OF OFFERORSLNSTRS., CONDS., AND NOTICES TO OFFERORSM

EVALUATION FACTORS FOR AWARDCONTRACTING OFFICER WILL COMPLETE ITEM 17 (SEALED-BID OR NEGOTIATED PROCUREMENT) OR 18 (SEALED-BID PROCUREMENT) AS APPLICABLE
17. X CONTRACTOR' S NEGOTIATED AGREEMENT (Contractor is required to sign this18.
SEALED-BID AWARD (Contractor is not required to sign this document.) Your bid on

document and return1

copies to issuing office.) Contractor agrees to,

Solicitation Number

furnish and deliver all items or perform all the services set forth or otherwise identified
above and on any continuation sheets for the consideration stated herein. The rights andincluding the additions or changes made by you which additions or changes are set forthin full above, is hereby accepted as to the items listed above and on any continuation

obligations of the parties to this contract shall be subject to and governed by the following
documents: (a) this award/contract, (b) the solicitation, if any, and (c) such provisions,representations, certifications, and specifications, as are attached or incorporated byreference herein. (Attachments are listed herein.)
19A. NAME AND TITLE OF SIGNER (Type or print)

sheets. This award consummates the contract which consists of the following
documents: (a) the Government's solicitation and your bid, and (b) this award/contract.
No further contractual document is necessary. (Block 18 should be checked only whenawarding a sealed-bid contract.)
20A. NAME OF CONTRACTING OFFICER(b) (6)19B(b) (6)BY

19C. DATE SIGNED

20B. UNITED STATES OF AMERICA

06/04/2018 BY(Signature of the Contracting Officer)

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition is NOT usable

20C. DATE SIGNED(b) (6)

STANDARD FORM 26 (Rev. 5/2011)
Prescribed by GSA - FAR (48 CFR) 53.214(a)Contract No. HHSO100201800016C
Cue Health, Inc

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SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS
B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES
This contract will demonstrate the feasibility of the development of a first in class(b) (4)molecular influenza diagnostic platform that is FDA cleared through 510K/CLIA Waived and will beultimately approved for over the counter use.
The assay will be focused on the detection of both emerging infectious diseases as well as amultiplex typing/subtyping influenza assay for detection and differentiation of Influenza A and B
and specific influenza A subtypes (H3N2 and H1N1). (b) (4)The Cue program will support the acceleration of analytical performance, verification, validation,
pre clinical, clinical studies and FDA submissions (510k and OTC).
The diagnostic product is a cartridge reader for multiple uses, disposable test cartridges, sample
collection devices, and a network enabled mobile device. (b) (4)The test is a nucleic acid amplification test (isothermal) along with ability to, depending on test
type, use the (b) (4)Current predicted time to result is <25 minutes
and the influenza diagnostic will utilize a lower nasal swab for sample collection.
B.2. TYPE OF CONTRACT AND ESTIMATED COST
a. This award is a COST REIMBURSEMENT (CR) type contract for Research and Development witha 20 month cost reimbursement Base Period. There is one 36 month Cost Plus Fixed Fee(CPFF) option period that may or may not be exercised. If exercised, the option could run
concurrently or in succession with a portion of the base. The total Period of Performance shallnot to exceed five (5) years.
b. The total estimated cost of the base period is $14,000,000
The total estimated cost of the option period is $14,963,315. The total fixed fee for the option
period is $1,036,863. The total estimated value of option period of the contract, CLINs 0002
and 0003, is $16,000,178
The total estimated dollar value of this contract is$30,000,178

Contract No. HHSO100201800016C
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4c. Base Period of Performance: June 4, 2018 through January 3, 2021
CLIN

Item Description

Estimated Cost

0001

Cue Health Monitoring Systemwith Cue Influenza Cartridge
and Cue Health Mobile
App/Professional App$14,000,000

Total$14,000,000

d. Unless the Government exercises its option(s) pursuant to the option clause referenced in
Section I, this contract consists only of the Base Period specified in the Statement of Work as
defined in SECTIONS C and F, for the estimated cost set forth under B.2.of this contract.
e. Pursuant to FAR Clause 52.217 9, Option to Extend the Term of the Contract set forth in
Section I. of this contract, the Government may, by unilateral contract modification, require
the Contractor to perform the option set forth in the Statement of Work in Section C andAttachment 8. If the Government exercises this option, notice must be given at least 30 days
prior to the expiration date of this contract. Deliverables as set forth in Section F willcommence on an agreed upon schedule if an option is exercised by the Government. The priceof this contract will be increased as set forth in paragraph f, below.
f. Upon exercise of the option the Government shall pay the Contractor on a cost plus fixed fee
basis for the work described in SECTION C of the contract and identified in the schedule
below:
Option Period of Performance: September 30, 2018 through September 29, 2021

CLIN

0002
0003
Total

Item Description
Multiplex Respiratory
Pathogen Cartridge (RSV,Corona Virus)
Supply Cue Cartridge andReader for Influenza
Natural History Studies

Total
Estimated Cost(b) (4)

Fixed Fee (7%for CLIN 0002
only)

Total
Estimated
Cost Plus Fixed
FeeContract No. HHSO100201800016C
Cue Health, Inc5

B.3. ADVANCED UNDERSTANDINGS
1. Export control notification: Contractor is responsible for ensuring compliance with allexport control laws and regulations that may be applicable to the export of and foreign
access to their proposed technologies. Contractor may consult with the Department ofState with any questions regarding the International Traffic in Arms Regulation (ITAR) (22CRF Parts 120 130) and /or the Department of Commerce regarding the Export
Administration Regulations (15 CRF Parts 730 774).
2. Persons-in-Plant: With seven (7) days advanced notice to the Contractor, in writing fromthe Contracting Officer, the Government may place two (2) persons in plant in theContractor’s facility or in any subcontractor’s portion of the facility in which the Contractor
has ongoing work within the scope of this contract. The individuals shall be subject to theContractor policies and procedures regarding security and facility access at all times whilein the Contractor’s facility.
3. Subcontracts, Consultants Equipment and Materials: Award of any fixed price subcontractthat exceeds $250,000 or 5% of the total estimated cost of the contract, or any cost
reimbursement, time and materials, or labor hour subcontracts or any equipment ormaterial purchase for the contract shall require Contracting Officer Approval (COA).
Supporting documentation required by FAR 52.244 2 must be submitted with the request.
After receiving written consent of the subcontract by the Contracting Officer, a copy of thesigned, executed subcontract and consulting agreement shall be provided to theContracting Officer within thirty (30) days.
Definitions:“Equipment” means a tangible item that is functionally complete for its intended purpose,
durable, nonexpendable, and needed for the performance of a contract. Equipment is notintended for sale, and does not ordinarily lose its identity or become a component part ofanother article when put into use. Equipment does not include material, real property,
special test equipment or special tooling.
“Durable” means foreseeable use beyond the R&D contract.
“Material” is described as consumables. Consumables are goods that are capable of being
consumed; that may be destroyed, dissipated, wasted, or spent.
NOTE: Cue Health, Inc. will be required to notify the Contracting Officer and keep a COA
log that contains the SOW, Master Consulting Services Agreement, and any proposed
resumes of key subcontractor personnel.
4. File Audits: All files may be audited by the US Government at any time in accordance with
FAR 52.215 2, Audit and Records Negotiation, during normal business hours, with a three(3) business day written notice.

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5. Information Disclosure: Disclosure of information/data received from the Governmentthat is sensitive in nature, in whole or in part, by the Contractor can only be made after theContractor receives prior written approval from the Contracting Officer. Whenever theContractor is uncertain with regard to the proper handling of information/data under thecontract, the Contractor shall obtain a written determination from the Contracting Officer.
Notwithstanding the foregoing, such information/data shall not be deemed of a sensitive
nature with respect to the Contractor for purposes of this contract if suchinformation/data: (a) was already known to the Contractor; (b) was generally available or
known, or was otherwise part of the public domain, at the time of its disclosure to theContractor; (c) became generally available or known, or otherwise became part of the
public domain, after its disclosure to, or, with respect to the information/data by, theContractor through no fault of the Contractor; (d) was disclosed to the Contractor, otherthan under an obligation of confidentiality or non use, by a third party who had no
obligation to the Government that controls such information/data not to disclose suchinformation/data to others; or (e) was independently discovered or developed by theContractor, as evidenced by its written records, without the use of information/data
belonging to the Government.
Contractor may disclose information/data of a sensitive nature provided by theGovernment to the extent that such disclosure is: (a) made in response to a valid order ofa court of competent jurisdiction or other supra national, federal, national, regional, state,provincial or local governmental or regulatory body of competent jurisdiction; provided,
however, that the Contractor shall first have given immediate notice to the Governmentand give the Government a reasonable opportunity to quash such order and/or to obtain aprotective order requiring that the information/data of a sensitive nature that is the
subject of such order be held in confidence by such court or agency or, if disclosed, be
used only for the purposes for which the order was issued. The Government has the rightto elect any and all remedies available to it in responding to any such order or similar legal
document; and provided further that if a disclosure order is not quashed or a protective
order is not obtained, the information/data disclosed in response to such court or
governmental order shall be limited to that information which is legally required to bedisclosed in response to such court or governmental order; (b) made by the Contractor to
the Regulatory Authorities as required in connection with any filing, application or request
for Regulatory Approval; provided, however, that all such information will be provided inadvance to the Contracting Officer for review and reasonable measures shall be taken toassure confidential treatment of such information/data. Notwithstanding the foregoing,
Contractor may disclose information/data sensitive to the Government if such disclosure isdeemed by Contractor legal counsel to be required for purposes of complying with laws,
rules or regulations of other governmental agencies, such as the Food and Drug
Administration or the Securities and Exchange Commission. In the event of any suchrequired disclosure, Contractor will notify the Contracting Officer in advance.

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6.

Testing of Cue Health, Inc. IVD against Pandemic Strains: The contractor shall, at therequest of the COR/CO, make Cue diagnostic devices and test cartridges manufactured
hereunder available to intergovernmental agencies to test cross reactivity against newand emerging strains of pandemic respiratory strains (influenza, other respiratory
diseases) should the need arise. Such testing will be conducted at no cost to the contractor
other than prototyping and manufacturing of devices. Study results shall be shared withthe contractor and all information will be kept confidential unless agreed upon by bothparties.

7.

Phase Review Meeting: It is anticipated that contractor shall prepare to presentation andbriefing to COR/CO upon completion of (b) (4)The phase review meeting will be gated toincorporate the go/no go milestone set forth in Section F.2 below to proceed with further
development of base period activities.

B.4. DIRECT COSTS
a. Items Unallowable Unless Otherwise Provided
Notwithstanding Clause 52.216 7, ALLOWABLE COST AND PAYMENT incorporated in thiscontract, unless authorized in writing by the Contracting Officer, the costs of the following
items or activities shall be unallowable as direct costs:(1) Conferences and Meetings;(2) Food for Meals, Light Refreshments, and Beverages;(3) Promotional Items [includes, but is not limited to: clothing and commemorative items
such as pens, mugs/cups, folders/folios, lanyards, and conference bags that are
sometimes provided to visitors, employees, grantees, or conference attendees.] ;(4) Acquisition, by purchase or lease, of any interest in real property;(5) Special rearrangement or alteration of facilities;(6) Purchase or lease of any item of general purpose office furniture or office equipment
regardless of dollar value. (General purpose equipment is defined as any items of
personal property which are usable for purposes other than research, such as officeequipment and furnishings, pocket calculators, etc.);(7) Travel to attend general scientific meetings;(8) Reserved;(9) Accountable Government Property (defined as non expendable personal property withan acquisition cost of $3,000 or more) and "sensitive items" (defined as items of personal
property (supplies and equipment that are highly desirable and easily converted topersonal use)), regardless of acquisition value;(10) Printing Costs (as defined in the Government Printing and Binding Regulations; and(11) Overtime (premium) compensation.
b. Items requiring written Contracting Officer’s Authorization prior to approval:

Contract No. HHSO100201800016C
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81) Entering into certain types of subcontract of arrangements (see above for specificobligations). Note that most consulting agreements require approval.
2) Foreign Travel (see below);3) Light Refreshment and Meal Expenditures Requests to use contract funds to provide lightrefreshments and/or meals to either federal or nonfederal employees must be submitted
to the Contracting Officer, with a copy to the Contracting Officer’s Representative (COR),
at least six (6) weeks in advance of the event and are subject to “HHS Policy on Promoting
Efficient Spending: Use of Appropriate Funding for Conferences and Meetings, Food andPromotional Items and Printing and Publications.” The request shall contain the following
information: (a) name, date, and location of the event at which the light refreshments
and/or meals will be provide; (b) a brief description of the purpose of the event; (c) a cost
breakdown of the estimated light refreshments and/or meals costs; (d) the number ofnonfederal and federal attendees receiving light refreshments and/or meals; and (e) if theevent will be held at a government facility.
4) Clinical Study Protocols a draft must be submitted for review and feedback in advance of
IRB submission.
5) Animal Study Protocols a draft must be submitted for review and feedback in advance of
IACUC submission.
Travel Costs
1) All travel must follow GSA regulations including per diem, cost of airfare, and expenses
incurred.
2) Foreign Travel: Total expenditures for foreign travel (transportation, lodging, subsistence,and incidental expenses) incurred in direct performance of this contract shall not exceed$0 without the prior written approval of the Contracting Officer.
3) The Contractor shall invoice and be reimbursed for all travel costs in accordance with
Federal Acquisition Regulations (FAR) 31.2 Contracts with Commercial Organizations,
Subsection 31.205 46, Travel Costs
In the event foreign travel is required, requests for foreign travel must be submitted atleast four weeks in advance and shall contain the following:(a) meeting (s) and place(s) to be visited, with costs and dates;(b) name(s) and title(s) of Contractor personnel to travel and their functions in thecontract project;(c) contract purposes to be served by the travel;(d) how travel of Contractor personnel will benefit and contribute to accomplishing theContract No. HHSO100201800016C
Cue Health, Inc9contract project, or will otherwise justify the expenditure of ASPR contract funds;(e) how such advantages justify the costs for travel and absence from the project of morethan one person if such are suggested; and(f) what additional functions may be performed by the travelers to accomplish otherpurposes of the contract and thus further benefit the project.

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SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT
C.1. STATEMENT OF WORK
a. Independently and not as an agent of the Government, the Contractor shall furnish all thenecessary services, qualified personnel, material, equipment, and facilities not otherwise
provided by the Government as needed to perform the detailed Statement of Work (SOW)
attached to this contract as Attachment SOW (SECTION J List of Attachments).
Statement of Work

The contractor will demonstrate the feasibility of the development of (b) (4)molecular influenza diagnostic test and platform that is FDA cleared through 510K/CLIA Waivedand (b) (4).
The contractor shall conduct necessary activities required for a FDA 510K CLIA Waived
amendment submission and(b) (4)by:BASE PERIOD Tasks:
ACTIVITY
Assay Development
Clinical Studies 510k/CLIA Waived (b) (4)Regulatory Submissions
Bioproduction Manufacturing
Cartridge Manufacturing
OPTION PERIOD Tasks
ACTIVITY
Multiplex Assay Development
Clinical Studies 510k/CLIA Waived (b) (4)Regulatory Submissions
Bioproduction Manufacturing
Cartridge Manufacturing (not to exceed 5,000 cartridges and 100 readers)C.2. REPORTING REQUIREMENTS
All reports required herein shall be submitted in electronic format.
All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of1973. Additional information about testing documents for Section 508 compliance, including
specific checklists, by application, can be found at: http://www.hhs.gov/web/508/index.html
under "Helpful Resources."Contract No. HHSO100201800016C
Cue Health, Inc

11a. Technical Reports
In addition to those reports required by the other terms of this contract, the Contractor shallprepare and submit the following reports in the manner stated below and in accordance with
the DELIVERIES Article in SECTION F of this contract:
1. Monthly Progress Report
This report shall include a description of the activities during the reporting period, and theactivities planned for the ensuing reporting period. The first reporting period consists ofthe first full month of performance plus any fractional part of the initial month.
Thereafter, the reporting period shall consist of full calendar months.
The Contractor shall submit a Monthly Progress Report according to the dates set forth in
ARTICLE F.2.of this contract. The format should include:
A cover page that includes the contract number and title; the type of report and periodthat it covers; the Contractor’s name, address, telephone number, fax number, and e mailaddress; and the date of submission; The progress report shall conform to therequirements set forth in the DELIVERABLES Article in SECTION F of this contract.
•
•
•
•

•

•

SECTION I – An introduction covering the purpose and scope of the contract effort
SECTION II PROGRESSSECTION II Part A: OVERALL PROGRESS A description of overall progress.
SECTION II Part B: MANAGEMENT AND ADMINISTRATIVE UPDATE A description of all
meetings, conference calls, etc. that have taken place during the reporting period.
Include progress on administration and management issues (e.g., evaluating, andmanaging subcontractor performance, and personnel changes). A standingorganizational chart is to be included in this section.
SECTION II Part C: TECHNICAL PROGRESS For each activity related to Gantt chart,
document the results of work completed and cost incurred during the period covered
in relation to proposed progress, effort and budget. The report shall be in sufficientdetail to explain comprehensively the results achieved. The description shall include
pertinent data and/or graphs in sufficient detail to explain any significant results
achieved and preliminary conclusions resulting from analysis and scientific evaluationof data accumulated to date under the contract. The report shall include a descriptionof problems encountered and proposed corrective action; differences between
planned and actual progress, why the differences have occurred and what corrective
actions are planned; preliminary conclusions resulting from analysis and scientificevaluation of data accumulated to date under the project.
SECTION II Part D: PROPOSED WORK A summary of work proposed related to Gantt
chart for the next reporting period and preprints/reprints of papers and abstracts. Anyrevisions to the Timeline, Work Breakdown Structure (WBS) and Risk Assessment.

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A Monthly Progress Report will not be required in the same month that the Annual
Technical Progress Report is submitted.
The first report shall be due the 15th calendar day after completion of the first fullCalendar month and portion thereof of performance. Thereafter, reports shall be due onor before the 15th calendar day following each reporting period.
2. Annual Progress Report
This report shall include a summation of the results of the entire contract work for theperiod covered. An Annual Technical Progress Report will not be required for the period
when the Final Technical Progress Report is due. Monthly Progress Reports shall not be
submitted in the same month when an Annual Progress Report is due.
The first Annual Progress Report shall be submitted in accordance with the date set forthin Section F of this contract. Each Annual Progress Report shall include:
A Cover page that includes the contract number and title; the type of report and periodthat it covers; the Contractor's name, address, telephone number, fax number, and e mailaddress; and the date of submission; The progress report shall conform to therequirements set forth in the DELIVERIES Article in SECTION F of this contract.
•
•
•
•

•

•

SECTION I: EXECUTIVE SUMMARY A brief overview of the work completed, and the
major accomplishments achieved during the reporting period.
SECTION II: PROGRESSSECTION II Part A: OVERALL PROGRESS A description of overall progress.
SECTION II Part B: MANAGEMENT AND ADMINISTRATIVE UPDATE A description of all
meetings, conference calls, etc. that have taken place during the reporting period.
Include progress on administration and management issues (e.g. evaluating, andmanaging subcontractor performance; regulatory compliance audits, and personnel
changes).
SECTION II Part C: TECHNICAL PROGRESS For each activity, document the results ofwork completed and cost incurred during the period covered in relation to proposed
progress, effort and budget. The report shall be in sufficient detail to explain
comprehensively the results achieved. The description shall include pertinent data
and/or graphs in sufficient detail to explain any significant results achieved andpreliminary conclusions resulting from analysis and scientific evaluation of data
accumulated to date under the contract. The report shall include a description ofproblems encountered and proposed corrective action; differences between planned
and actual progress, why the differences have occurred and what corrective actions
are planned; preliminary conclusions resulting from analysis and scientific evaluationof data accumulated to date under the project;
SECTION II Part D: PROPOSED WORK A summary of work proposed for the next
year’s performance period to include an updated Gantt Chart.

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Contractor also should include the following in the Annual Progress Report:
a. Copies of manuscripts (published and unpublished), abstracts, and any protocols or
methods developed specifically under the contract during the reporting period; andb. A summary of any Subject Inventions per the requirements under FAR Clause 52.227
11.
The first report shall cover the period June 4, 2018 through May 31, 2019 of this contractand shall be due within 30 Calendar days after the Anniversary Date of the Contract.
3. Draft Final Technical Progress Report and Final Technical Progress Report
A Draft Final Report will be submitted to the Contracting Officer’s Representative forreview and comment at least 45 days prior to the contract completion date. Within 15
days of receipt, the Contracting Officer’s Representative will provide the Contractor
written comments on the Draft Final Report.
These reports are to include a summation of the work performed and results obtained forthe entire contract period of performance. This report shall be in sufficient detail todescribe comprehensively the results achieved. The Draft Final Report and Final Reportshall be submitted in accordance with the DELIVERIES Article in SECTION F of the contract.
An Annual Technical Progress Report will not be required for the period when the Final
Technical Progress Report is due. The Draft Final Technical Progress Report and the Final
Technical Progress Report shall be submitted in accordance with the dates set forth in
ARTICLE F.2. of this contract. The report shall conform to the following format:
a. Cover page to include the contract number, contract title, performance period
covered, Contractor's name and address, telephone number, fax number, e mailaddress and submission date.
b. SECTION I: EXECUTIVE SUMMARY Summarize the purpose and scope of the contracteffort including a summary of the major accomplishments relative to the specificactivities set forth in the Statement of Work.
c. SECTION II: RESULTS A detailed description of the work performed related to theGantt chart, the results obtained, and the impact of the results on the scientific and/or
public health community including a listing of all manuscripts (published and in
preparation) and abstracts presented during the entire period of performance and asummary of all inventions.
Draft Technical Progress Report: The Contractor is required to submit the Draft Final
Technical Progress Report to the Contracting Officer's Representative and Contracting
Officer. This report is due 45 calendar days before the completion date of the contract.
The Contracting Officer's Representative and Contracting Officer will review the Draft Final

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Technical Progress Report and provide the Contractor with comments within 15 Calendar
days after receipt.
Final Technical Progress Report: The Contractor shall incorporate all BARDA comments
into the Final Technical Progress Report. The Contractor will deliver the final version of
the Final Technical Progress Report 30 Calendar days post technical period of
performance.
4. Summary of Salient Results
The Contractor shall submit, with the Final Report, a summary (not to exceed 400 words)of salient results achieved during the performance of the contract.
5. Copies of FDA/ Regulatory Agency Correspondence and Meeting Summaries
a. The Contractor shall forward the initial draft minutes and final draft minutes of any
formal meeting with the FDA and other regulatory agencies to the COR.
b. The Contractor shall forward the final draft minutes of any informal meeting with the
FDA and other regulatory agencies to the COR.
c. The Contractor shall forward the dates and times of any meeting with the FDA andother regulatory agencies to the COR and make arrangements for appropriate COR andstaff to attend the meetings.
d. The Contractor shall provide the COR the opportunity to review and comment uponany draft documents, including draft pre submission packages, and meeting requests,
to be submitted to the FDA or other regulatory agency. The Contractor shall provide
the COR with five (5) business days in which to review and provide comments back to
the Contractor.
6. FDA/Regulatory Agency Submissions
The Contractor shall provide COR 14 calendar days, the opportunity to review and comment
upon all draft submissions before submission to the FDA. Contractor shall provide COR with anelectronic copy of the final FDA submission. All documents shall be duly marked as either“Draft” or “Final”.
Administrative submissions (correspondence that will not be used to support a regulatory
strategy position) may be supplied to the COR/CO at the time of FDA submission.
7. Other Reports/Deliverables
a. Study/Experiment/Test Plans/Protocols/Batch Records - The Contractor shallsubmit (14 days in advance) all study/experiment/test plans, designs, and protocols
for review and feedback. COR/CO reserve the right to make any suggestions andrequests for clarification prior to conduct of said activity.
b. The Contractor shall forward Standard Operating Procedures (SOPs) pertinent to
the work hereunder upon request from Contracting Officer’s RepresentativeContract No. HHSO100201800016C
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15/Contracting Officer.
c. The Contractor shall provide upon request animal study and/or other technology
packages developed under this contract. Packages shall include complete
protocols and critical reagents for animal models developed and/or improved with
contract funding.
d. The Contractor shall provide upon request raw data and/or specific analysis of data
first produced with USG funds.
e. Meeting Minutes - The Contractor shall provide an electronic copy of conference
call meeting minutes/summaries to the Contracting Officer's Representative andContracting Officer within five (5) business days after the conference call is held.
f. Written request for modifications to current product design and specifications COR/CO must be notified of any major modifications or changes tomaterials/reagents/components used, current product design and/or specifications
requiring a change in any Certificate of Analysis (COA).
g. Audit Reports – Report is required whenever an audit pertinent to the work
hereunder occurs.
h. Reporting of Financial Conflict of Interest (FCOI) - All reports anddocumentation required by 45 CFR Part 94, Responsible Prospective Contractors
including, but not limited to, the New FCOI Report, Annual FCOI Report, Revised
FCOI Report, and the Mitigation Report, shall be submitted to the Contracting
Officer in electronic format. Thereafter, reports shall be due in accordance with theregulatory compliance requirements in 45 CFR Part 94. 45 CFR Part 94 is available
at: http://www.ecfr.gov/cgi bin/text
idx?c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45 . See Part 94.5, Management and reporting of financial
conflicts of interest for complete information on reporting requirements.
C.3. SUBJECT INVENTION REPORTING REQUIREMENT
All reports and documentation required by FAR Clause 52.227 11 Patent Rights Ownership by theContractor, including, but not limited to, the invention disclosure report, the confirmatory license,
and the Government support certification, one copy of an annual utilization report, and a copy ofthe final invention statement, shall be submitted to the Contracting Officer. A final invention
statement (see FAR 27.303 (b)(2)(ii)) shall be submitted to the Contracting Officer on the
expiration date of the contract. Reports and documentation submitted to the Contracting Officer
shall be sent to the following email and/or address:
HHS/ASPR/AMCG
ATTN, (b) (6)Contracting Officer
US DEPT OF HEALTH & HUMAN SERVICESASST SEC OF PREPAREDNESS & RESPONSE
ACQ MANAGEMENT, CONTRACTS, & GRANTS#21E02 O'NEILL HOUSE OFFICE BUILDING
Washington DC 20515 Email:(b) (4)Contract No. HHSO100201800016C
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If no invention is disclosed or no activity has occurred on a previously disclosed invention during
the applicable reporting period, a negative report shall be submitted to the Contracting Officer at
the address listed above.
The Government agrees that the background inventions listed at Attachment 8 to this contract
shall not be considered “Subject Inventions” under FAR 52.227 11.
C.4. MONTHLY CONFERENCE CALLS
Two conference calls between the Contracting Officer’s Representative and the Contractor shalloccur every month, or as directed by the Contracting Officer’s Representative. During these calls
the Principal Investigator/Main Point of Contact will discuss the activities performed anddeliverables achieved during the reporting period, any problems that have arisen and theactivities planned for the ensuing reporting period. The first reporting period consists of the firsthalf month of performance plus any fractional part of the initial month. Thereafter, the reporting
period shall consist of each half calendar month. The Contractor may choose to include other key
personnel on the conference call to give detailed updates on specific projects or the Contracting
Officer may request this.
C.5. PROJECT MEETINGSThe Contractor shall participate in Project Meetings to coordinate the performance of thecontract, as requested by the Contracting Officer's Representative. These meetings may include
face to face meetings with AMCG/BARDA in Washington, D.C. and at work sites of the Contractor.
Such meetings may include, but are not limited to, meetings of the Contractor to discuss study
designs, site visits to the Contractor's facilities, and meetings with the Contractor and HHS officials
to discuss the technical, regulatory, and ethical aspects of the program. Subject to the data rights
provisions in this contract and other appropriate confidentiality protections, the Contractor must
provide data, reports, and presentations to groups of outside experts and USG personnel as
required by the Contracting Officer's Representative in order to facilitate review of contract
activities.
C.6. IN-PROCESS-REVIEWAt its discretion, the Government may conduct an In Process Review (IPR) to evaluate whether tocontinue activities covered by the contract. Contractor shall provide a presentation detailingtechnical progress made towards completion of milestones following a prescribed template
provided by the Government at an agreed upon date. The IPR will typically be conducted at DHHS
facilities in Washington, DC. The contractor will be notified by the Government of its intention to
hold an IPR at least 30 calendar days prior to the scheduled IPR Presentation.
•

Contractor shall provide final presentation 10 business days prior to each IPR Presentation.

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•
•

Contractor shall submit written justification of progress towards satisfying success criteria.
If draft is provided prior to the final presentation submission, the Government will provide awritten or verbal response, as appropriate.

C.7. SITE VISITS AND INSPECTIONSAt the discretion of the USG and with seven (7) business days’ notice to the Contractor, the USG
reserves the right to conduct site visits and inspections on contractor and subcontractors on an asneeded basis.

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SECTION D - PACKAGING, MARKING AND SHIPPING
Packaging
As required, packaging and labeling of products developed under this contract shall beconsistent with the FDA guidance on regulatory requirements for medical devices – i.e.,
applicable provisions under Parts of Title 21 CFR Part 801, 809, 812, 820, 830, 1010.
Shipping
Shipment of deliverables will be at the direction of the Contracting Officer.
Report Deliverables
All reports and deliverables required under this contract shall be packaged, marked andshipped in accordance with Government specifications. At a minimum, all deliverables shallbe marked with the contract number and Contractor name. The Contractor shall guaranteethat all required materials shall be delivered in immediate usable and acceptable condition.
Unless otherwise specified by the Contracting Officer, delivery of reports to be furnished to
the Government under this contract (including invoices) shall be delivered to the Contracting
Officer electronically along with a concurrent email notification to the Contracting Officer and
COR (as defined in SECTION G, CONTRACT ADMINISTRATION) summarizing delivery as follows:
Mailing Address

Mailing Address(b) (4)(b) (4)Contracting Officer's Representative
DHHS/OS/ASPR/BARDA
O’Neill House Office Building#21E09Washington, D.C. 20515

Contracting Officer
DHHS/OS/ASPR/AMCG
O’Neill House Office Building#21E02
Washington, D.C. 20515

E Mail Address

E Mail Address(b) (4)(b) (4)

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SECTION E - INSPECTION AND ACCEPTANCE
a. The Contracting Officer or the duly authorized representative will perform inspection andacceptance of materials and services to be provided under this contract.
b. For the purpose of this SECTION, the designated Contracting Officer's Representative (COR) is theauthorized representative of the Contracting Officer.
c. For report deliverables, inspection and acceptance will be performed at:
Office of Acquisition Management, Contracts, and Grants (AMCG)
Office of the Assistant Secretary for Preparedness and Response
U.S. Department of Health and Human Services
330 Independence Avenue, S.W., Room G644
Washington, D.C. 20201
d. For option items, inspection and acceptance will be performed at the specified delivery site.
e. FAR 52.252 2 CLAUSES INCORPORATED BY REFERENCE
This contract incorporates one or more clauses by reference, with the same force and effect as if
they were given in full text. Upon request, the Contracting Officer will make their full text
available. Also, the full text of a clause may be accessed electronically at this/these address:
http://www.acquisition.gov.
FAR Clause 52.246-9, Inspection of Research and Development (Short Form)(Apr 1984).

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Item Description
9. Formal FDA Submissions of any
kind pertaining to the scope of the
project as necessary during
Contract performance

Delivery Date
No later than 14 calendar
days before submission to
the FDA* BARDA will
coordinate with
Contractor for reviewing
BLA sections

10. Memo with Date and Time of
Scheduled Meetings with FDA. BARDA
reserves the right to attend FDA
meetings relevant to contract funded
activities
11. Communications from FDA related
to contract funded activities

As soon as possible afterscheduling

12. Minutes for Formal Meetings with
FDA

Within 5 business days ofreceipt from FDA

Deliver To

Within 2 business days ofreceipt from FDA

13. Raw Data and Analysis
Within a reasonable time
Pertaining to Scope of the Project
after requestFirst Produced Using USG Funds
14. Regulatory Strategies Pertaining to Within a reasonable timeafter request
Scope of the Project
15. Draft Final Report
No later than 45 days prior
to contract expiration

CO via electronicdeliveryCO via electronicdelivery
CO and COR via e-mail16. Final Report

No later than 30
calendar days after
contract period of
performance
expiration

CO and COR via e-mail17. Publications/Presentations

No later than 30
calendar days
before submission
for publications and15 calendar days forpresentations

CO and COR via e-mailF.4. CLAUSES INCORPORATED BY REFERENCE (FEBRUARY 1998)
This contract incorporates the following clause by reference, with the same force and effect as if itwere given in full text. Upon request, the Contracting Officer will make its full text available. Also,
the full text of a clause may be accessed electronically at this address:
http://www.acquisition.gov/comp/far/index.html .

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FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:
52.242-15, Stop Work Order (AUGUST 1989) with ALTERNATE I (APRIL 1984).
52.242-17, Government Delay of Work (APRIL 1984)
52.247-35, F.O.B. Destination Within Consignees Premises (APRIL 1984).
SECTION G - CONTRACT ADMINISTRATION DATA
G.1. CONTRACTING OFFICER
The following Contracting Officer (CO) will represent the Government for the purpose of thiscontract:(b) (6)

HHS/OS/ASPR/AMCG
O’Neill House Office Building#21E02
Washington, D.C. 20515
E mail: (b) (6)1) The Contracting Officer is the only individual who can legally commit the Government to theexpenditure of public funds. No person other than the Contracting Officer can make any changes
to the terms, conditions, general provisions, or other stipulations of this contract.
2) The Contracting Officer is the only person with the authority to act as agent of the Government
under this contract. Only the Contracting Officer has authority to (1) direct or negotiate anychanges in the statement of work; (2) modify or extend the period of performance; (3) change
the delivery schedule; (4) authorize reimbursement to the Contractor of any costs incurred during
the performance of this contract; (5) otherwise change any terms and conditions of this contract.
3) No information, which may be received from any person employed by the US Government, orotherwise, shall be considered grounds for deviation from any stipulation of this contract, unless
it is information which may be contained in an authorized modification to this contract, duly
issued by the Contracting Officer.
4) The Government may unilaterally change its CO designation.
G.2. CONTRACTING OFFICER'S REPRESENTATIVE (COR)
The following Contracting Officer's Representative (COR) will represent the Government for the purpose ofthis contract:(b) (6)

Contracting Officer’s Representative (COR)
Biomedical Advanced Research and Development Authority (BARDA)

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Office of the Assistant Secretary for Preparedness and Response
Department of Health and Human Services
The COR is responsible for:1) Monitoring the Contractor's technical progress, including the surveillance and assessment of
performance and recommending to the Contracting Officer changes in requirements;
2) Assisting the Contracting Officer in interpreting the statement of work and any other technicalperformance requirements;
3) Performing technical evaluation as required;
4) Performing technical inspections and acceptances required by this contract; and5) Assisting in the resolution of technical problems encountered during performance.
The COR will assist in resolving technical issues that arise during performance. The COR however is
not authorized to change any contract terms or authorize any changes in the Statement of Work or
modify or extend the period of performance, or authorize reimbursement of any costs incurred
during performance. The Contractor is advised to review Federal Acquisition Regulation ("FAR")
Clause 52.243 2 (Changes Cost reimbursement contracts Alternative V), which is incorporated byreference into this contract.
The Contracting Officer is the only person with authority to act as agent of the Government under
this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes inthe statement of work; (2) modify or extend the period of performance; (3) change the delivery
schedule; (4) authorize reimbursement to the Contractor for any costs incurred during theperformance of this contract; or (5) otherwise change any terms and conditions of this contract. The
Government may unilaterally change its COR designation.
G.3. INVOICE SUBMISSION/CONTRACT FINANCIAL REPORT
1) Financial reports on the attached Financial Report of Individual Project/Contract (see Attachment3) shall be submitted by the Contractor in accordance with the instructions for completing thisform, which accompany the form, in an electronic copy, not later than the 15th business day after
the close of the reporting period. The line entries for subdivisions of work and elements of cost
(expenditure categories) which shall be reported within the total contract are discussed inparagraph 5, below. Subsequent changes and/or additions in the line entries shall be made inwriting.
2) Unless otherwise stated in that part of the instructions for completing this form, entitled"PREPARATION INSTRUCTIONS," (see Attachment 3) all columns A through J, shall be completed
for each report submitted.
3) The first financial report shall cover the period consisting of the first full calendar month following
the date of the contract, in addition to any fractional part of the initial month. Thereafter, reports
will be on a Monthly basis. If the contractor fails to submit timely financial reports and invoices

Contract No. HHSO100201800016C
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or is delinquent on submission of financial reports by an excess of 90 Calendar days, a “Stop Work
Order” may be issued by the Government, until the delay is resolved.
4) The Contracting Officer may require the Contractor to submit detailed support for costs
contained in one or more interim financial reports. This clause does not supersede the record
retention requirements in FAR Part 4.7.
5) The listing of expenditure categories to be reported is incorporated within the Attachment
entitled, "Financial Report of Individual Project/Contract," located in SECTION J and made a partof this contract.
G.4. INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORTING
1) The billing address that should be shown on the invoice is the same as defined above in Section Gof this contract.
2) The Contractor shall submit an electronic copy of contract Monthly invoices/financial reports to
the Contracting Officer as defined above, in Section G of this contract.
3) Contractor invoices/financial reports shall conform to the form, format, and content
requirements of the instructions for Invoice/Financing requests and Contract Financial Reporting
made a part of the contract in Section J (See Attachments 1, 2, 3).
4) Monthly invoices must include the cumulative total expenses to date, adjusted (as applicable) toshow any amounts suspended by the Government.
5) The Contractor agrees to immediately notify the Contracting Officer in writing if there is ananticipated overrun (any amount) or unexpended balance (greater than 10 percent) of theestimated costs for the base segment or any option segment(s) (See estimated costs under B.2.
and B.3., of the contract) and the reasons for the variance. Also refer to the requirements of theLimitation of Cost FAR 52.232 20 clause in the contract.
6) All invoice submissions shall be in accordance with FAR Clause 52.232 25(a)(3) in Section I of thiscontract.
7) The Contractor shall reference any applicable Contractor Officer Authority (COA) numbers whenrequesting reimbursement on the invoice.
G.5. REIMBURSEMENT OF COST
1) The Government shall reimburse the Contractor the cost determined by the Contracting Officer
to be allowable (hereinafter referred to as allowable cost) in accordance with the clause entitled
Allowable Cost and Payment in Section I, Contract Clauses, and FAR Subpart 31.2. Examples ofallowable costs include, but are not limited to, the following:

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36a) All direct materials and supplies that are used in the performing of the work provided forunder the contract, including those purchased for subcontracts and purchase orders.
b) All direct labor, including supervisory, that is properly chargeable directly to the contract, plus
fringe benefits.
c) All other items of cost budgeted for and accepted in the negotiation of this basic contract ormodifications thereto.
d) Travel costs including per diem or actual subsistence for personnel while in an actual travel
status in direct performance of the work and services required under this contract subject tothe following and the restrictions in Section B:(i) Air travel shall be by the most direct route using “air coach” or “air tourist” (less than firstclass) unless it is clearly unreasonable or impractical (e.g., not available for reasons otherthan avoidable delay in making reservations, would require circuitous routing or entail
additional expense offsetting the savings on fare, or would not make necessaryconnections).
(ii) Rail travel shall be by the most direct route, first class with lower berth or nearest
equivalent.
(iii) Costs incurred for lodging, meals, and incidental expenses shall be considered reasonable
and allowable to the extent that they comply with FAR 31.2.
(iv) Travel via privately owned automobile shall be reimbursed at not more than the current
General Services Administration (GSA) FTR established mileage rate.
e)

For further guidance on funding, see the LIMITATION OF COSTS clause referenced in Part II,
Contract Clauses.

G.6. GOVERNMENT PROPERTY
a. In addition to the requirements of the clause, GOVERNMENT PROPERTY, incorporated in SECTION
I of this contract, the Contractor shall comply with the provisions of HHS Publication, "HHSContracting Guide for Contract of Government Property," which is incorporated into this contract
by reference. This document can be accessed at:
http://oamp.od.nih.gov/sites/default/files/appendix q hhs contracting guide.pdf
Among other issues, this publication provides a summary of the Contractor's responsibilities
regarding purchasing authorizations and inventory and reporting requirements under thecontract.

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Requests for information regarding property under this contract should be directed to theContracting Officer.
b. Notwithstanding the provisions outlined in the HHS Publication, "HHS Contracting Guide forContract of Government Property," which is incorporated in this contract in paragraph a. above,
the Contractor shall use the form entitled, "Report of Government Owned, Contractor Held
Property" for submitting summary reports required under this contract, as directed by theContracting Officer or his/her designee. This form is included as an attachment in SECTION J ofthis contract.
G.7. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCEa. Contractor Performance Evaluations
Interim and final evaluations of Contractor performance will be prepared on this contract inaccordance with FAR Subpart 42.15. The final performance evaluation will be prepared at thetime of completion of work. In addition to the final evaluation, interim evaluation will be
prepared after completion of one year of performance.
Interim and final evaluations will be provided to the Contractor as soon as practicable after
completion of the evaluation. The Contractor will be permitted thirty days to review the
document and to submit additional information or a rebutting statement. If agreement cannot
be reached between the parties, the matter will be referred to an individual one level above theContracting Officer, whose decision will be final.
Copies of the evaluations, Contractor responses, and review comments, if any, will be retained aspart of the contract file, and may be used to support future award decisions.
b. Electronic Access to Contractor Performance Evaluations
Contractors may access evaluations through a secure Web site for review and comment at thefollowing address: http://www.cpars.gov.
G.8. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS, FAR 52.232-40(December 2013)
a. Upon receipt of accelerated payments from the Government, the Contractor shall makeaccelerated payments to its small business subcontractors under this contract, to the maximum
extent practicable and prior to when such payment is otherwise required under the applicable
contract or subcontract, after receipt of a proper invoice and all other required documentationfrom the small business subcontractor.
b. The acceleration of payments under this clause does not provide any new rights under the
prompt Payment Act.

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G10. OVERTIME COMPENSATION
No overtime (premium) compensation is authorized under the subject contract. Billing of laborcosts shall be limited to total actual hours worked in the billing period.
SECTION H - SPECIAL CONTRACT REQUIREMENTS
H.1. PROTECTION OF HUMAN SUBJECTS, HHSAR 352.270-4(b) (December 2015)
a. The Contractor agrees that the rights and welfare of human subjects involved in research under thiscontract shall be protected in accordance with 45 CFR Part 46 and with the Contractor's current federal
wide Assurance of Compliance on file with the Office for Human Research Protections (OHRP),
Department of Health and Human Services. The Contractor further agrees to provide certification at least
annually that the Institutional Review Board has reviewed and approved the procedures, which involve
human subjects in accordance with 45 CFR Part 46 and the Assurance of Compliance.
b. The Contractor shall bear full responsibility for the performance of all work and services involving the useof human subjects under this contract and shall ensure that work is conducted in a proper manner and assafely as is feasible. The parties hereto agree that the Contractor retains the right to control and direct
the performance of all work under this contract. The Contractor shall not deem anything in this contract
to constitute the Contractor or any subcontractor, agent or employee of the Contractor, or any otherperson, organization, institution, or group of any kind whatsoever, as the agent or employee of theGovernment. The Contractor agrees that it has entered into this contract and will discharge its
obligations, duties, and undertakings and the work pursuant thereto, whether requiring professional
judgment or otherwise, as an independent contractor without imputing liability on the part of theGovernment for the acts of the Contractor or its employees.
c. Contractors involving other agencies or institutions in activities considered to be engaged in research
involving human subjects must ensure that such other agencies or institutions obtain their own FWA ifthey are routinely engaged in research involving human subjects or ensure that such agencies or
institutions are covered by the Contractors' FWA via designation as agents of the institution of via
individual investigator agreements (see OHRP website at:
http//:www.hhs.gov/ohrp/policy/guidanceonalternativeofwa.pdf).
d. If at any time during the performance of this contract, the Contracting Officer determines, in consultation
with OHRP that the Contractor is not in compliance with any of the requirements and/or standards
stated in paragraphs (a) and (b) above, the Contracting Officer may immediately suspend, in whole or inpart, work and further payments under this contract until the Contractor corrects thenoncompliance. The Contracting Officer may communicate the notice of suspension by telephone withconfirmation in writing. If the Contractor fails to complete corrective action within the period of time
designated in the Contracting Officer's written notice of suspension, the Contracting Officer may, after
consultation with OHRP, terminate this contract in whole or in part.
H.2. HUMAN SUBJECTS
Research projects involving humans and/or human specimens can only be initiated with written approval by
the Contracting Officer’s Representative.
The Good Clinical Practice Regulations (GCP)(21 CFR Parts 50, 54, 56)(45 CFR Part 46)(ICH E6) as well as otherContract No. HHSO100201800016C
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applicable Federal and state regulations will be standards that apply for use of human subject and/or humanspecimens in clinical studies.
If at any time during the life of the contract, the Contractor fails to comply with GCP as identified byregulations outline above , the Contractor shall have thirty (30) Calendar days from the time such material
failure is identified to cure such or initiate cure to the satisfaction of the Government Contracting Officer’s
Representative. If the Contractor fails to take such an action within the thirty (30) Calendar day period, thenthe contract may be terminated.
H.3. HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE)a.

The acquisition and supply of all human specimen material (including fetal material) used under thiscontract shall be obtained by the Contractor in full compliance with applicable State and Local laws
and the provisions of the Uniform Anatomical Gift Act in the United States, and no undue
inducements, monetary or otherwise, will be offered to any person to influence their donation ofhuman material.
The Contractor shall provide written documentation that all human materials obtained as a result ofresearch involving human subjects conducted under this contract, by collaborating sites, or bysubcontractors identified under this contract, were obtained with prior approval by the Office for
Human Research Protections (OHRP) of an Assurance to comply with the requirements of 45 CFR 46 toprotect human research subjects. This restriction applies to all collaborating sites without OHRP
approved Assurances, whether domestic or foreign, and compliance must be ensured by theContractor.
Provision by the Contractor to the Contracting Officer of a properly completed "Protection of Human
Subjects Assurance Identification/IRB Certification/Declaration of Exemption", Form OMB No. 0990
0263(formerly Optional Form 310), certifying IRB review and approval of the protocol from which thehuman materials were obtained constitutes the written documentation required. The human subject
certification can be met by submission of a self designated form, provided that it contains theinformation required by the "Protection of Human Subjects Assurance Identification/IRB
Certification/Declaration of Exemption", Form OMB No. 0990 0263(formerly Optional Form 310).

H.4 MANUFACTURING STANDARDSThe Good Manufacturing Practice Regulations (GMP)( pertaining to diagnostic products (21 CFR Part 820,
Quality System Regulation) apply to manufacturing, processing, packaging, storage and delivery of thisproduct.
If at any time during the life of the contract, the Contractor fails to comply with GMP in the manufacturing,processing, packaging, storage, stability and other testing of the product and such failure results in a material
adverse effect on the safety, purity or potency of the product (a material failure) as identified by the FDA, theContractor shall have thirty (30) calendar days from the time such material failure is identified to cure suchmaterial failure. If the Contractor fails to take such an action to the satisfaction of the Contracting Officer’s
Representative within the thirty (30) calendar day period, then the contract may be terminated.
H.5. NEEDLE DISTRIBUTION
The Contractor shall not use contract funds to carry out any program of distributing sterile needles orContract No. HHSO100201800016C
Cue Health, Inc41syringes for the hypodermic injection of any illegal drug.
H.6 RESERVED
H.7. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH
The Contractor shall not use contract funds for (1) the creation of a human embryo or embryos for research
purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly
subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR
46.204(b) and Section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)). The term "human embryo
or embryos" includes any organism, not protected as a human subject under 45 CFR 46 as of the date of theenactment of this Act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one
or more human gametes or human diploid cells.
Additionally, in accordance with a March 4, 1997 Presidential Memorandum, Federal funds may not be used
for cloning of human beings.
H.8. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATIONThe Contractor shall not use contract funds to disseminate information that is deliberately false or
misleading.
H.9. PRIVACY ACT APPLICABILITY
1) Notification is hereby given that the Contractor and its employees are subject to criminal penalties forviolation of the Privacy Act to the same extent as employees of the Government. The Contractor shallassure that each of its employees knows the prescribed rules of conduct and that each is aware that heor she can be subjected to criminal penalty for violation of the Act. A copy of 45 CFR Part 5b, Privacy Act
Regulations, may be obtained at
http://www.gpo.gov/fdsys/granule/CFR 2007 title45 vol1/CFR 2007 title45 vol1 part5b2) The COR is hereby designated as the official who is responsible for monitoring contractor compliancewith the Privacy Act.
3) The Contractor shall follow the Privacy Act guidance as contained in the Privacy Act System of Records
number 09 25 0200. This document may be obtained at the following link:
http://www.hhs.gov/foia/privacy/sorns.html
H.11

RESERVED

H.12. CONFLICT OF INTEREST
The Contractor represents and warrants that, to the best of the Contractor's knowledge and belief, there are
no relevant facts or circumstances which could give rise to an organizational conflict of interest, as defined in
FAR 2.101 and Subpart 9.5, or that the Contractor has disclosed all such relevant information. Prior toContract No. HHSO100201800016C
Cue Health, Inc42commencement of any work, the Contractor agrees to notify the Contracting Officer promptly that, to thebest of its knowledge and belief, no actual or potential conflict of interest exists or to identify to theContracting Officer any actual or potential conflict of interest the Contractor may have. In emergency
situations, however, work may begin but notification shall be made within five (5) working days. The
Contractor agrees that if an actual or potential organizational conflict of interest is identified duringperformance, the Contractor shall promptly make a full disclosure in writing to the Contracting Officer. This
disclosure shall include a description of actions which the Contractor has taken or proposes to take, after
consultation with the Contracting Officer, to avoid, mitigate, or neutralize the actual or potential conflict ofinterest. The Contractor shall continue performance until notified by the Contracting Officer of any contrary
action to be taken. Remedies include termination of this contract for convenience, in whole or in part, if theContracting Officer deems such termination necessary to avoid an organizational conflict of interest. If theContractor was aware of a potential organizational conflict of interest prior to award or discovered an actualor potential conflict after award and did not disclose it or misrepresented relevant information to theContracting Officer, the Government may terminate the contract for default, debar the Contractor from
Government contracting, or pursue such other remedies as may be permitted by law or this contract.
H.13 RESERVED
H.14. PUBLICATION AND PUBLICITY
Except for necessary release to approved subcontractors and in connection with regulatory reporting
requirements, no information related to data obtained under this contract shall be released or publicizedwithout the prior written consent of BARDA. In this case, BARDA will be informed no later than theregulatory agency requiring the information.
In addition to the requirements set forth in HHSAR Clause 352.227-70, Publications and Publicity
incorporated by reference in SECTION I of this contract, Section 507 of P.L. 104 208 mandates thatContractors funded with Federal dollars, in whole or in part, acknowledge Federal funding when issuingstatements, press releases, requests for proposals, bid solicitations and other documents. .
For purposes of this contract "publication" is defined as an issue of printed material offered for distribution
or any communication or oral presentation of information, including any manuscript or scientific meeting
abstract. Any publication containing data generated under this contract must be submitted for BARDA
review no less than thirty (30) Calendar days for manuscripts and fifteen (15) Calendar days for abstracts
before submission for public presentation or publication. Contract support shall be acknowledged in all such
publications substantially as follows:"This project has been funded in whole or in part with Federal funds from the Department
of Health and Human Services; Office of the Assistant Secretary for Preparedness andResponse; Biomedical Advanced Research and Development Authority, under Contract No.
HHSO100201XXX
H.15. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE
Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in HHS funded
programs is encouraged to report such matters to the HHS Inspector General's Office in writing or on the
Inspector General's Hotline. The toll free number is 1-800-HHS-TIPS (1-800-447-8477). All telephone calls
will be handled confidentially. The website to file a complaint on line is:
http://oig.hhs.gov/fraud/hotline/ and the mailing address is:Contract No. HHSO100201800016C
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US Department of Health and Human Services
Office of Inspector General
ATTN: OIG HOTLINE OPERATIONS
P.O. Box 23489
Washington, D.C. 20026
H.16. PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST ACTIVITIESThe Contractor acknowledges that U.S. Executive Orders and Laws, including but not limited to E.O. 13224
and P.L. 107 56, prohibit transactions with, and the provision of resources and support to, individuals andorganizations associated with terrorism. It is the legal responsibility of the Contractor to ensure compliancewith these Executive Orders and Laws. This clause must be included in all subcontracts issued under thiscontract.
H.17. USE OF FUNDS FOR PROMOTIONAL ITEMSThe Contractor shall not use contract funds to purchase promotional items. Promotional items include, but
are not limited to: clothing and commemorative items such as pens, mugs/cups, folders/folios, lanyards, andconference bags that are sometimes provided to visitors, employees, grantees, or conference attendees.
This includes items or tokens given to individuals as these are considered personal gifts for which contract
funds may not be expended.
H.18. EPA ENERGY STAR REQUIREMENTS
In compliance with Executive Order 12845 (requiring Agencies to purchase energy efficient computerequipment) all microcomputers, including personal computers, monitors, and printers that are purchasedusing Government funds in performance of a contract shall be equipped with or meet the energy efficient
low power standby feature as defined by the EPA Energy Star program unless the equipment always meets
EPA Energy Star efficiency levels. The microcomputer, as configured with all components, must be EnergyStar compliant.
This low power feature must already be activated when the computer equipment is delivered to the agency
and be of equivalent functionality of similar power managed models. If the equipment will be used on a local
area network, the vendor must provide equipment that is fully compatible with the network environment. In
addition, the equipment will run commercial off the shelf software both before and after recovery from its
energy conservation mode.
H.19 RESERVED
H.20. CARE OF LIVE VERTEBRATE ANIMALS, HHSAR 352.270-5(b) (December 2015)
a. Before undertaking performance of any contract involving animal related activities where the species isregulated by USDA, the Contractor shall register with the Secretary of Agriculture of the United States inaccordance with 7 U.S.C. 2136 and 9 CFR sections 2.25 through 2.28. The Contractor shall furnish
evidence of the registration to the Contracting Officer.

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b. The Contractor shall acquire vertebrate animals used in research from a dealer licensed by the Secretaryof Agriculture under 7 U.S.C. 2133 and 9 CFR Sections 2.1 2.11, or from a source that is exempt fromlicensing under those sections.
c. The Contractor agrees that the care, use and intended use of any live vertebrate animals in theperformance of this contract shall conform with the Public Health Service (PHS) Policy on Humane Care of
Use of Laboratory Animals (PHS Policy), the current Animal Welfare Assurance (Assurance), the Guide for
the Care and Use of Laboratory Animals (National Academy Press, Washington, DC) and the pertinent
laws and regulations of the United States Department of Agriculture (see 7 U.S.C. 2131 et seq. and 9 CFR
Subchapter A, Parts 1 4). In case of conflict between standards, the more stringent standard shallgovern.
d. If at any time during performance of this contract, the Contracting Officer determines, in consultation
with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), that theContractor is not in compliance with any of the requirements and standards stated in paragraphs (a)through (c) above, the Contracting Officer may immediately suspend, in whole or in part, work andfurther payments under this contract until the Contractor corrects the noncompliance. Notice of thesuspension may be communicated by telephone and confirmed in writing. If the Contractor fails tocomplete corrective action within the period of time designated in the Contracting Officer's written
notice of suspension, the Contracting Officer may, in consultation with OLAW, NIH, terminate thiscontract in whole or in part, and the Contractor's name may be removed from the list of thosecontractors with approved Assurances.
Note: The Contractor may request registration of its facility and a current listing of licensed dealers fromthe Regional Office of the Animal and Plant Health Inspection Service (APHIS), USDA, for the region inwhich its research facility is located. The location of the appropriate APHIS Regional Office, as well as
information concerning this program may be obtained by contacting the Animal Care Staff, USDA/APHIS,
4700 River Road, Riverdale, Maryland 20737 (E mail: ace@aphis.usda.gov ; Web site:(http://www.aphis.usda.gov/animal welfare .
H.21. ANIMAL WELFARE
All research involving live, vertebrate animals shall be conducted in accordance with the Public HealthService Policy on Humane Care and Use of Laboratory Animals (PHS Policy). The PHS Policy can be accessed
at: http://grants1.nih.gov/grants/olaw/references/phspol.htm
H.22. RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS
The Contractor shall not use contract funds to maintain or establish a computer network unless suchnetwork blocks the viewing, downloading, and exchanging of pornography.
H.23. GUN CONTROLThe Contractor shall not use contract funds in whole or in part, to advocate or promote gun control.
H.24 RESERVED
H.25. KEY PERSONNEL, HHSAR 352.242-70 (January 2006)

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The key personnel specified in this contract are considered to be essential to work performance. At least 30
days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible,
if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), theContractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion
or replacement request (including proposed substitutions for key personnel) to permit evaluation by theGovernment of the impact on performance under this contract. The Contractor shall not divert or otherwise
replace any key personnel without the written consent of the Contracting Officer. The Government may
modify the contract to add or delete key personnel at the request of the Contractor or Government.
The following individuals are considered to be essential to the work being performed hereunder:
Individual

Organization

Role

Ayub Khattak

Cue Health, Inc

CEO, PI

Andy Hudak

Cue Health, Inc

Program Manager Lead

Deborah Morris

Cue Health, Inc

Director, Regulatory and Clinical Affairs

Siaw Yen Lim

Cue Health, Inc

Director, Quality

Chi Hui Liang

Cue Health, Inc

Director of Research and Development

H.26. HIGHLY PATHOGENIC AGENTS
The work being conducted under this contract may involve a Highly Pathogenic Agent (HPA). The NIAID
defines an HPA as a pathogen that, under any circumstances, warrants a biocontainment safety level of BSL3
or higher according to either:
1. The current edition of the CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL) andcan be accessed at http://www.cdc.gov/OD/ohs/biosfty/bmbl5/bmbl5toc.htm
2. The Contractor's Institutional Biosafety Committee (IBC) or equivalent body,
3. The Contractor's appropriate designated institutional biosafety official, or
4. Documentation of compliance with CDC and USDA Select Agent Programs, where appropriate, forexample in the case of testing with highly pathogenic avian influenza viruses (e.g. H5N1 and H7N9).
If there is ambiguity in the BMBL guidelines and/or there is disagreement among the BMBL, an IBC or
equivalent body, or institutional biosafety official, the highest recommended containment level must beused.
H.27. CLINICAL RESEARCH
These Clinical Terms apply to all grants and contracts that involve clinical research.
The Government shall have unlimited rights to all protocols, data generated from the execution of these
protocols, and final reports first produced and funded by the Government under this contract, as defined inContract No. HHSO100201800016C
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46

Rights in Data Clause in FAR 52.227 14 (Alternative II). The Government reserves the right to request that
the Contractor provide any contract deliverable in a non proprietary form, to ensure the Government has
the ability to review and distribute the deliverables, as the Government deems necessary within the context
of this contract.
H.28. SAFETY AND MONITORING ISSUES
Institutional Review Board (IRB) or Independent Ethics Committee (IEC) Approval
Before award and then with the annual progress report, the Contractor must submit to the Government a
copy of the current IRB or IEC approved informed consent document, documentation of continuing review
and approval and the Office of Human Research Protections (OHRP) FWA number for the institution or site.
If other institutions are involved in the research (e.g., a multicenter clinical trial or study), each institution's
IRB or IEC must review and approve the protocol. They must also provide the Government initial and annual
documentation of continuing review and approval, including the current approved informed consent
document and FWA number.
The grantee institution must ensure that the applications as well as all protocols are reviewed by their IRB orIEC.
To help ensure the safety of participants enrolled in BARDA funded studies, the Contractor must provide theGovernment a summary explanation and copies of documents related to all major changes in the status ofongoing protocols, including the following:
1. All amendments or changes to the protocol, identified by protocol version number, date, or both anddate it is valid.
2. All changes in informed consent documents, identified by version number, date, or both and dates it isvalid.
3. Termination or temporary suspension of patient accrual.
4. Termination or temporary suspension of the protocol.
5. Any change in IRB approval.
6. Any other problems or issues that could affect the participants in the studies.
Contractors must notify BARDA through the Contracting Officer’s Representative (COR) or Contracting Officer(CO) of any of the above changes by email within 72 hours for items 3 – 6 and 7 days for items 1 – 2, followed
by a letter signed by the institutional business official, detailing notification of the change of status to the
local IRB and a copy of any responses from the IRB or IEC.
If a clinical protocol has been reviewed by an Institutional Bio safety Committee (IBC) or the NIH
Recombinant DNA Advisory Committee (RAC), the Contractor must provide information about the initial andongoing review and approval, if any. See the NIH Guidelines for Research Involving Recombinant DNA
Molecules.
H.29

RESERVED

H.30. BARDA PROTOCOL REVIEW PROCESS BEFORE PATIENT ENROLLMENT BEGINSBARDA has a responsibility to ensure that mechanisms and procedures are in place to protect the safety ofparticipants in BARDA supported clinical trials. Therefore, before patient accrual or participant enrollment,
the Contractor must provide the following (as applicable) for review by the Government:

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1. Draft clinical research protocol identified by version number, date, or both, including details of study
design, proposed interventions, patient eligibility, and exclusion criteria.
2. Documentation of IRB or IEC approval, including OHRP FWA number, IRB or IEC registration number,and IRB or IEC name.
3. Draft informed consent template, identified by version number, date, or both and date it is valid.
4. Plans for the management of side effects.
5. Procedures for assessing and reporting adverse events.
6. Plans for data and safety monitoring, and monitoring of the clinical study site, pharmacy, andlaboratory.
7. Documentation that the Contractor and all study staff responsible for the design or conduct of theresearch have received Good Clinical Practice (GCP) training in the protection of human subjects.
BARDA comments will be forwarded to the Contractor within two weeks (10 business days) of receipt of theabove information. The Contractor must address in writing all study design, safety, regulatory, ethical, andconflict of interest concerns raised by the COR to the satisfaction of the Government before patient accrualor participant enrollment can begin. After the Government receives the corrected documentation, a written
Contracting Officer Authorization (COA) Letter will be provided to the Contractor. This COA provides
authorization to the Contractor to execute the specific clinical study funded in part or in whole by theGovernment.
H.31. REQUIRED TIME SENSITIVE NOTIFICATION
Under the contract, the Contractor must submit to the Contracting Officer's Representative (COR) as follows:
1. Expedited safety report of unexpected or life threatening experience or death – A copy of any reportof unexpected or life threatening experience or death associated with the use of an IND drug, whichmust be reported to FDA by telephone or fax as soon as possible but no later than seven days after
the IND sponsor’s receipt of the information, must be submitted within 24 hours of knowledge orwhen Contractor should have known of the event.
2. Expedited safety reports of serious, and unexpected adverse experiences – A copy of any report ofunexpected and serious adverse experience associated with use of an IND drug or any finding fromtests in laboratory animals that suggests a significant risk for human subjects, which must be reported
in writing to FDA as soon as possible but no later than 15 days after the IND sponsor’s receipt of theinformation, must be submitted to the Contracting Officer’s Representative within 48 hours of theoccurrence of the event.
3. IDE reports of unanticipated adverse device effect – A copy of any reports of unanticipated adverse
device effect submitted to FDA must be submitted to the BARDA Contracting Officer’s Representative
within 24 hours of the occurrence of the event.
4. Expedited safety reports – should be sent to the COR concurrently with the report to FDA.
5. Other adverse events documented during the course of the trial should be included in the annual IND
or IDE report and reported to the BARDA annually.
In case of problems or issues, the COR will contact the Contractor within 10 working days by email, followed
within 7 calendar days by an official letter to the Contractor. The Contractor shall forward the official letterto the principal investigator listing issues and appropriate actions to be discussed.

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Safety reporting for research not performed under an IND or IDE
Ongoing safety reporting requirements for research not performed under an IND or IDE shall be mutuallyagreed upon by the Contracting Officer’s Representative and the Contractor.
H.32. BARDA CLINICAL TRIAL DATABASE INFORMATION REPORTING
The contractor must be prepared to provide initial information on each clinical study conducted under thiscontract to the COR. Study specific information is required at study start up and regular updates on site bysite enrollment will be required. Study specific information may include phase of study, ages of subjects
being studied, number of subjects planned, estimated start and completion dates, subcontractor information
and role on study, clinical site information. Clinical site information may include site Principal Investigator,
location, FWA number and expiration date, certification of site human subjects training as required by OHRP.
Updated information on enrollment will include site by site enrollment including the number of subjects
screened, enrolled (dosed), withdrew, and completed. Enrollment information will be provided on a regularbasis as determined by the CO prior to study start.
It is expected to have an electronic transfer of study specific data sets from the Contractor’s automatedinformation management systems or other data sources and files directly to a secure data capture system
known as the BARDA Tracking Tool. Standard Data Submissions refers to the electronic transfer of study
specific, de identified data sets from the contractor’s automated information management systems or otherdata sources directly to another automated information management system. BARDA’s information
management system is automated. Submission of data to BARDA’s system will be done through secure filetransfer protocol (sFTP). Data submission can be done manually or automatically, depending on thecontractor’s preference and capability. Similarly, in most cases data will be able to be automaticallygenerated from a contractor’s system. The BARDA Tracking Tool will go through a testing phase to ensure
appropriate handover of data from contractors. BARDA’s secure data capture system is known as the BARDA
Tracking Tool or BTT.
PART II – CONTRACT CLAUSESSECTION I – CONTRACT CLAUSESFAR 52.252 2 Clauses Incorporated by Reference (Feb 1998)
This contract incorporates one or more clauses by reference, with the same force and effect as if they were
given in full text. Upon request, the Contracting Officer will make their full text available.
I.1.

FEDERAL ACQUISITION REGULATION (FAR) (48 CFR Chapter 1) CLAUSES

Full text of the FAR clauses may be accessed electronically at: https://www.acquisition.gov/far/index.html
FAR CLAUSE NO.
52.202-1
52.203-3
52.203-5
52.203-6
52.203-7
U

U

U

U

DATE
Nov 2013
Apr 1984
May 2014
Sep 2006
May 2014
U

U

TITLE
Definitions
Gratuities
Covenant Against Contingent Fees
Restrictions on Subcontractor Sales to the Government
Anti-Kickback Procedures
U

U

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FAR CLAUSE NO.
52.203-8
U

U

U

U

DATE
May 2014
UU

52.203-10
52.203-12

May 2014
Oct 2010

52.203-13
52.203-14
52.203-17

Oct 2015
Oct 2015
Apr 2014

52.204-4
52.204-7
52.204-10
52.204-13
52.209-6

May 2011
Oct 2016
Oct 2016
Jul 2013
Oct 2016

52.209-952.209-10
52.210-1
52.215-2
52.215-8
52.215-10
52.215-12
52.215-15
52.215-17
52.215-18

Jul 2013
Nov 2015
Apr 2011
Oct 2010
Oct 1997
Aug 2011
Oct 2010
Oct 2010
Oct 1997
Jul 2005

52.215-19
52.215-21

Oct 1997
Oct 2010

52.215-23
52.216-7
52.216-8
52.219-8

Oct 2009
Jun 2013
Jun 2011
Nov 2016

52.222-2

Jul 1990

52.222-3
52.222-21
52.222-26
52.222-35
52.222-36
52.222-37
52.222-40
52.222-50
52.222-54
52.223-6
52.223-18
52.224-1
52.224-2

Jun 2003
Apr 2015
Sep 2016
Oct 2015
Jul 2014
Feb 2016
Dec 2010
Mar 2015
Oct 2015
May 2011
Aug 2011
April 1984
April 1984

TITLE
Cancellation, Rescission, and Recovery of Funds for Illegal or Improper
Activity
Price or Fee Adjustment for Illegal or Improper Activity
Limitation on Payments to Influence Certain Federal Transactions (Over$150,000)
Contractor Code of Business Ethics and Conduct
Display of Hotline Poster(s)Contractor Employee Whistleblower Rights and Requirement to Inform
Employees of Whistleblower Rights
Printed or Copied Double-Sided on Postconsumer Fiber Content Paper
System for Award Management
Reporting Executive Compensation and First-Tier Subcontract Awards
System for Award Management MaintenanceProtecting the Government's Interests When Subcontracting With
Contractors Debarred, Suspended, or Proposed for Debarment
Updates of Publicly Available Information Regarding Responsibility Matters
Prohibition on Contracting With Inverted Domestic Corporations
Market Research
Audit and Records Negotiation
Order of Precedence - Uniform Contract Format
Price Reduction for Defective Cost or Pricing Data
Subcontractor Cost or Pricing Data
Pension Adjustments and Asset Reversions
Waiver of Facilities Capital Cost of Money
Reversion or Adjustment of Plans for Post-Retirement Benefits (PRB)
other than Pensions
Notification of Ownership Changes
Requirements for Certified Cost or Pricing Data and Data Other Than
Certified Cost or Pricing Data - Modifications
Limitations on Pass-Through Charges
Allowable Cost and Payment
Fixed Fee
Utilization of Small Business Concerns
U

U

Payment for Overtime Premiums (The use of overtime is authorizedunder this contract if the overtime premium does not exceed * $0; See
G.10)
Convict Labor
Prohibition of Segregated Facilities
Equal Opportunity
Equal Opportunity for VeteransAffirmative Action for Workers with Disabilities
Employment Reports on Veterans
Notification of Employee Rights Under the National Labor Relations Act
Combating Trafficking in Persons
Employment Eligibility Verification
Drug-Free Workplace
Encouraging Contractor Policy to Ban Text Messaging While Driving
Privacy Act Notification
Privacy Act

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FAR CLAUSE NO.
52.225-13
52.227-1
52.227-2
52.227-11
U

U

U

U

52.227-14
52.227-14 Alternate II52.227-16
52.232-9
52.232-17
52.232-20
52.232-23
52.232-25
52.232-33
52.232-40
52.233-1
52.233-3
52.233-4
52.242-1
52.242-3
52.242-4
52.242-13
52.243-2
52.244-2
52.244-5
52.244-6
52.245-1
52.245-952.246-23
52.247-63
52.249-6
52.249-14
52.251-1

DATE
Jun 2008
Dec 2007
Dec 2007
May 2014
U

U

May 2014
Dec 2007

Jun 1987
Apr 1984
May 2014
Apr 1984
May 2014
Jan 2017
Jul 2013
Dec 2013
May 2014
Aug 1996
Oct 2004
Apr 1984
May 2014
Jan 1997
Jul 1995
Aug 1987
Oct 2010
Dec 1996
Nov2017
Jan 2017
Apr 2012
Feb 1997
Jun 2003
May 2004
Apr 1984
Apr 2012

TITLE
Restrictions on Certain Foreign Purchases
Authorization and Consent, Alternate I (Apr 1984)
Notice and Assistance Regarding Patent and Copyright Infringement
Patent Rights - Ownership by the Contractor (Note: In accordance with
FAR 27.303(b)(2), paragraph (e) is modified to include the requirements
in FAR 27.303(b)(2)(i) through (iv). The frequency of reporting in (i) is
annual.
Rights in Data-General
Rights in Data General, Alternate II. Completed portion as follows:
Limited Rights Notice (Dec 2007)UU(a) These data are submitted with limited rights under Government
Contract No HHSO1002018000XXC. These data may be reproduced andused by the Government with the express limitation that they will not,without written permission of the Contractor, be used for purposes ofmanufacture nor disclosed outside the Government; except that theGovernment may disclose these data outside the Government for thefollowing purposes, provided that the Government makes such disclosure
subject to prohibition against further use and disclosure:(i) Use (except for manufacture) by support service
contractors.
(ii) Evaluation by nongovernment evaluators.
(b) This Notice shall be marked on any reproduction of these data, inwhole or in part.
Additional Data Requirements
Limitation on Withholding of Payments
Interest
Limitation of Cost
Assignment of Claims
Prompt Payment, Alternate I (Feb 2002)
Payment by Electronic Funds Transfer System for Award Management
Providing Accelerated Payments to Small Business Subcontractors
Disputes
Protest After Award, Alternate I (Jun 1985)
Applicable Law for Breach of Contract Claim
Notice of Intent to Disallow Costs
Penalties for Unallowable Costs (Over $700,000)
Certification of Final Indirect Costs
Bankruptcy
Changes - Cost Reimbursement, Alternate V (Apr 1984)
Subcontracts (June 2007)
Competition in Subcontracting
Subcontracts for Commercial Items
Government Property, Alternate II (Apr 2012)
Use and Charges
Limitation of Liability
Preference for U.S.-Flag Air Carriers
Termination (Cost-Reimbursement)
Excusable Delays
Government Supply Sources

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FAR CLAUSE NO.
52.253-1
U

U

U

DATE
Jan 1991

U

U

U

TITLE
Computer Generated Forms
U

U

I.2.
DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION(HHSAR) (48 CFR Chapter 3) CLAUSES
Full text of the HHSAR clauses can be found at http://www.hhs.gov/grants/contracts/contract-policiesregulations/hhsar/tocindetail/index.html.

HHSAR
CLAUSE NO.
352.203-70
352.222-70
352.223-70
352.224-70
352.227-70
352.231-70
352.233-71
352.237-75
352.270-4b352.270-6
U

U

U

I.3.

U

DATE

U

U

TITLE

U

U

Dec 2015
Dec 2015
Dec 2015
Dec 2015
Dec 2015
Dec 2015
Dec 2015
Dec 2015
Dec 2015
Dec 2015

Anti-Lobbying
Contractor Cooperation in Equal Employment Opportunity Investigations
Safety and HealthPrivacy Act
Publications and Publicity
Salary Rate Limitation
Litigation and Claims
Key Personnel
Protection of Human Subjects
Restriction on use of Human Subjects

ADDITIONAL CONTRACT CLAUSES

I.3.1. Additional Federal Acquisition Regulation (FAR) (48 CFR Chapter 1) Clauses – In Full Text
This contract incorporates the following clauses in full text.
FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:
a. FAR Clause 52.217-9, Option to Extend the Term of the Contract (Mar 2000)(1) The Government may extend the term of this contract by written notice to the Contractor within 30 days after the Government
has completed its analysis of the deliverables associated with the applicable milestone. The Government will provide theContractor a preliminary written notice of its intent to extend at least 30 days before the contract expires. The preliminary noticedoes not commit the Government to an extension.
(2) If the Government exercises this option, the extended contract shall be considered to include this option clause.
(3) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 5 years.

b. FAR Clause 52.219-28, Post-Award Small Business Program Representation (Jul 2013).
(a) Definitions. As used in this clause-Long-term contract means a contract of more than five years in duration, including options. However, the term does not include
contracts that exceed five years in duration because the period of performance has been extended for a cumulative period not toexceed six months under the clause at 52.217-8, Option to Extend Services, or other appropriate authority.

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Small business concern means a concern, including its affiliates, that is independently owned and operated, not dominant in thefield of operation in which it is bidding on Government contracts, and qualified as a small business under the criteria in 13 CFR part
121 and the size standard in paragraph (c) of this clause. Such a concern is “not dominant in its field of operation” when it does not
exercise a controlling or major influence on a national basis in a kind of business activity in which a number of business concerns
are primarily engaged. In determining whether dominance exists, consideration shall be given to all appropriate factors, including
volume of business, number of employees, financial resources, competitive status or position, ownership or control of materials,
processes, patents, license agreements, facilities, sales territory, and nature of business activity.
(b) If the Contractor represented that it was a small business concern prior to award of this contract, the Contractor shall
rerepresent its size status according to paragraph (e) of this clause or, if applicable, paragraph (g) of this clause, upon theoccurrence of any of the following:(1) Within 30 days after execution of a novation agreement or within 30 days after modification of the contract to include
this clause, if the novation agreement was executed prior to inclusion of this clause in the contract.
(2) Within 30 days after a merger or acquisition that does not require a novation or within 30 days after modification of
the contract to include this clause, if the merger or acquisition occurred prior to inclusion of this clause in the contract.
(3) For long-term contracts—(i) Within 60 to 120 days prior to the end of the fifth year of the contract; and(ii) Within 60 to 120 days prior to the date specified in the contract for exercising any option thereafter.
(c) The Contractor shall rerepresent its size status in accordance with the size standard in effect at the time of thisrerepresentation that corresponds to the North American Industry Classification System (NAICS) code assigned to this contract.
The small business size standard corresponding to this NAICS code can be found at http://www.sba.gov/content/table-smallbusiness-size-standards .
(d) The small business size standard for a Contractor providing a product which it does not manufacture itself, for a contract otherthan a construction or service contract, is 500 employees.
(e) Except as provided in paragraph (g) of this clause, the Contractor shall make the representation required by paragraph (b) of
this clause by validating or updating all its representations in the Representations and Certifications section of the System forAward Management (SAM) and its other data in SAM, as necessary, to ensure that they reflect the Contractor’s current status. The
Contractor shall notify the contracting office in writing within the timeframes specified in paragraph (b) of this clause that the data
have been validated or updated, and provide the date of the validation or update.
(f) If the Contractor represented that it was other than a small business concern prior to award of this contract, the Contractor
may, but is not required to, take the actions required by paragraphs (e) or (g) of this clause.
(g) If the Contractor does not have representations and certifications in SAM, or does not have a representation in SAM for the
NAICS code applicable to this contract, the Contractor is required to complete the following rerepresentation and submit it to thecontracting office, along with the contract number and the date on which the rerepresentation was completed:
The Contractor represents that it [X ] is, [ ] is not a small business concern under NAICS Code 541711 assigned to contract
number HHSO100201800016C.[Contractor to sign and date and insert authorized signer's name and title].

(b) (4)b.

52.232-40 – Providing Accelerated Payments to Small Business Subcontractors (Dec 2013)(a) Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small
business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise

Contract No. HHSO100201800016C
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required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation fromthe small business subcontractor.
(b) The acceleration of payments under this clause does not provide any new rights under the Prompt Payment Act.
(c) Include the substance of this clause, including this paragraph (c), in all subcontracts with small business concerns, including
subcontracts with small business concerns for the acquisition of commercial items.

PART III – ATTACHMENTS
SECTION J – LIST ATTACHMENTS
The following documents are attached and incorporated in this contract:
Attachment 1: Invoice/Financing Request Instructions and Contract Financial Reporting Instructions for
BARDA Cost Reimbursement Type Contracts.
Attachment 2: Sample Invoice Form
Attachment 3: Financial Report of Individual Project/Contract
Attachment 4: Safety and Health, HHSAR Clause 352.223 70, dated 1/2006
Attachment 5: Disclosure of Lobbying Activities, SF LLL, dated 7/1997.
Located at: http://www.whitehouse.gov/sites/default/files/omb/grants/sflllin.pdf.
Attachment 6: Report of Government Owned, Contractor Held Property, dated 10/2014.
Located at: http://oamp.od.nih.gov/sites/default/files/DGS/contracting forms/Govt Owned Prop.pdf
Attachment 7: Statement of Work
Attachment 8: Subject Inventions
ATTACHMENT #1
INVOICE/FINANCING REQUEST INSTRUCTIONS - FOR COST-REIMBURSEMENT TYPE CONTRACTS
Format: Payment requests shall be submitted on the Contractor’s self-generated form in the manner and format prescribedherein and as illustrated in the Sample Invoice/Financing Request. Standard Form 1034, Public Voucher for Purchases and Services
Other Than Personal, may be used in lieu of the Contractor’s self-generated form provided it contains all of the information shownon the Sample Invoice/Financing Request. DO NOT include a cover letter with the payment request.
Number of Copies: Payment requests shall be submitted in the quantity specified in the Invoice Submission Instructions in Section
G of the Contract Schedule.
Frequency: Payment requests shall not be submitted more frequently than once monthly in accordance with the Allowable Cost
and Payment Clause incorporated into this contract. Small business concerns may submit invoices/financing requests more
frequently than every two weeks when authorized by the Contracting Officer.
Cost Incurrence Period: Costs incurred must be within the contract performance period or covered by pre-contract costprovisions.
Billing of Costs Incurred: If billed costs include (1) costs of a prior billing period, but not previously billed, or (2) costs incurred
during the contract period and claimed after the contract period has expired, the Contractor shall site the amount(s) and month(s)Contract No. HHSO100201800016C
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in which it incurred such costs.
Contractor's Fiscal Year: Payment requests shall be prepared in such a manner that the Government can identify costs claimed
with the Contractor's fiscal year.
Currency: All BARDA contracts are expressed in United States dollars. When the Government pays in a currency other than UnitedStates dollars, billings shall be expressed, and payment by the Government shall be made, in that other currency at amounts
coincident with actual costs incurred. Currency fluctuations may not be a basis of gain or loss to the Contractor. Notwithstanding
the above, the total of all invoices paid under this contract may not exceed the United States dollars authorized.
Costs Requiring Prior Approval: Costs requiring the Contracting Officer's approval, including those set forth in an Advance
Understanding in the contract, shall be identified and reference the Contracting Officer's Authorization (COA) Number. In addition,
the Contractor shall show any cost set forth in an Advance Understanding as a separate line item on the payment request.
Invoice/Financing Request Identification: Each payment request shall be identified as either:(a) Interim Invoice/Contract Financing Request: These are interim payment requests submitted during the contract
performance period.
(b) Completion Invoice: The completion invoice shall be submitted promptly upon completion of the work, but no later than
one year from the contract completion date, or within 120 days after settlement of the final indirect cost rates covering theyear in which the contract is physically complete (whichever date is later). The Contractor shall submit the completion
invoice when all costs have been assigned to the contract and it completes all performance provisions.
(c) Final Invoice: A final invoice may be required after the amounts owed have been settled between the Government and theContractor (e.g., resolution of all suspensions and audit exceptions).
Preparation and Itemization of the Invoice/Financing Request: The Contractor shall furnish the information set forth in the
instructions below. The instructions are keyed to the entries on the Sample Invoice/Financing Request.
(a) Designated Billing Office Name and Address: Enter the designated billing office name and address, as identified in the
Invoice Submission Instructions in Section G of the Contract Schedule.
(b) Contractor's Name, Address, Point of Contact, VIN, and DUNS or DUNS+4 Number: Show the Contractor's name andaddress exactly as they appear in the contract, along with the name, title, phone number, and e-mail address of the person
to notify in the event of an improper invoice or, in the case of payment by method other than Electronic Funds Transfer, towhom payment is to be sent. Provide the Contractor’s Vendor Identification Number (VIN), and Data Universal Numbering
System (DUNS) number or DUNS+4. The DUNS number must identify the Contractor’s name and address exactly as stated on
the face page of the contract. When an approved assignment has been made by the Contractor, or a different payee has
been designated, provide the same information for the payee as is required for the Contractor (i.e., name, address, point ofcontact, VIN, and DUNS).
(c) Invoice/Financing Request Number: Insert the appropriate serial number of the payment request.
(d) Date Invoice/Financing Request Prepared: Insert the date the payment request is prepared.
(e) Contract Number and Order Number (if applicable): Insert the contract number and order number (if applicable).
(f)
Effective Date: Insert the effective date of the contract or if billing under an order, the effective date of the order.
(g) Total Estimated Cost of Contract/Order: Insert the total estimated cost of the contract, exclusive of fixed-fee. If billingunder an order, insert the total estimated cost of the order, exclusive of fixed-fee. For incrementally funded
contracts/orders, enter the amount currently obligated and available for payment.
(h) Total Fixed-Fee: Insert the total fixed-fee (where applicable) or the portion of the fixed-fee applicable to a particular invoice
as defined in the contract.
(i)
Two-Way/Three-Way Match: Identify whether payment is to be made using a two-way or three-way match. To determine
required payment method, refer to the Invoice Submission Instructions in Section G of the Contract Schedule.
(j)
Office of Acquisitions: Insert the name of the Office of Acquisitions, as identified in the Invoice Submission Instructions in
Section G of the Contract Schedule.
(k) Central Point of Distribution: Insert the Central Point of Distribution, as identified in the Invoice Submission Instructions in
Section G of the Contract Schedule.
(l)Billing Period: Insert the beginning and ending dates (month, day, and year) of the period in which costs were incurred andfor which reimbursement is claimed.
(m) Amount Billed - Current Period: Insert the amount claimed for the current billing period by major cost element, including
any adjustments and fixed-fee. If the Contract Schedule contains separately priced line items, identify the contract line
item(s) on the payment request and include a separate breakdown (by major cost element) for each line item.
(n) Amount Billed - Cumulative: Insert the cumulative amounts claimed by major cost element, including any adjustments andfixed-fee. If the Contract Schedule contains separately priced line items, identify the contract line item(s) on the payment
request and include a separate breakdown (by major cost element) for each line item.
(o) Direct Costs: Insert the major cost elements. For each element, consider the application of the paragraph entitled "Costs
Requiring Prior Approval" on page 1 of these instructions.
(1) Direct Labor: Include salaries and wages paid (or accrued) for direct performance of the contract. List individuals by
name, title/position, hourly/annual rate, level of effort (actual hours or % of effort), breakdown by task performed by

Contract No. HHSO100201800016C
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personnel, and amount claimed.
Fringe Benefits: List any fringe benefits applicable to direct labor and billed as a direct cost. Do not include in thiscategory fringe benefits that are included in indirect costs.
(3) Accountable Personal Property: Include any property having a unit acquisition cost of $5,000 or more, with a life
expectancy of more than two years, and sensitive property regardless of cost (see the HHS Contractor's Guide forControl of Government Property)(e.g. personal computers). Note this is not permitted for reimbursement without preauthorization from the CO.
On a separate sheet of paper attached to the payment request, list each item for which reimbursement is requested.
Include reference to the following (as applicable):- Item number for the specific piece of equipment listed in the Property Schedule, and- COA number, if the equipment is not covered by the Property Schedule.
The Contracting Officer may require the Contractor to provide further itemization of property having specificlimitations set forth in the contract.
(4) Materials and Supplies: Include all consumable material and supplies regardless of amount. Detailed line-item
breakdown (e.g. receipts, quotes, etc.) is required.
(5) Premium Pay: List remuneration in excess of the basic hourly rate.
(6) Consultant Fee: List fees paid to consultants. Identify consultant by name or category as set forth in the contract or
COA, as well as the effort (i.e., number of hours, days, etc.) and rate billed.
(7) Travel: Include domestic and foreign travel. Foreign travel is travel outside of Canada, the United States and its
territories and possessions. However, for an organization located outside Canada, the United States and its territories
and possessions, foreign travel means travel outside that country. Foreign travel must be billed separately fromdomestic travel.
(8) Subcontract Costs: List subcontractor(s) by name and amount billed. Provide subcontract invoices/receipts as backup
documentation. If subcontract is of the cost-reimbursement variety, detailed breakdown will be required. Regardless,include backup documentation (e.g. subcontractor invoices, quotes, etc.).
(9) Other: Include all other direct costs not fitting into an aforementioned category. If over $1,000, list cost elements anddollar amounts separately. If the contract contains restrictions on any cost element, that cost element must be listed
separately.
(p) Cost of Money (COM): Cite the COM factor and base in effect during the time the cost was incurred and for which
reimbursement is claimed, if applicable.
(q) Indirect Costs: Identify the indirect cost base (IDC), indirect cost rate, and amount billed for each indirect cost category.
(r) Fixed-Fee: Cite the formula or method of computation for fixed-fee, if applicable. The fixed-fee must be claimed asprovided for by the contract.
(s) Total Amounts Claimed: Insert the total amounts claimed for the current and cumulative periods.
(t) Adjustments: Include amounts conceded by the Contractor, outstanding suspensions, and/or disapprovals subject toappeal.
(u) Grand Totals(v) Certification of Salary Rate Limitation: If required by the contract (see Invoice Submission Instructions in Section G of theContract Schedule), the Contractor shall include the following certification at the bottom of the payment request:“I hereby certify that the salaries billed in this payment request are in compliance with the Salary Rate Limitation Provisions
in Section H of the contract.”**Note the Contracting Officer may require the Contractor to submit detailed support for costs claimed on payment requests.
Every cost must be determined to be allocable, reasonable, and allowable per FAR Part 31.
(2)

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56
ATTACHMENT #2
SAMPLE INVOICE FORM

Contract No. HHSO100201800016C
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57
Company Name
Designated Billing Office Name and Address:

Invoice/Finance Number:

DHHS/OS/ASPR/AMCG
Attn: Contract ng Off cer
200 C St., S.W.

Date Invoice Prepared:

Wash ngton, D.C. 20201

Effective Date:

Contractor’s Address and Contact Information:

Total Estimated Cost of Order:

Contract No.

Office of Acquisitions:Contract ng Off cer ( nsert name here)
Off ce of Acqu s t ons Management, Contracts, andGrants (AMCG)
POC: Name of accountant or COO or s gnatory author ty for nvo ce
T t e:
Phone:
E-Ma :

Central Point of Distribution:

TIN:
DUNS #:Th s nvo ce represents re mbursab e costs for the per od fromCurrent

Expenditure Category
Direct Costs:
D rect Labor
Fr nge Benef ts
Total Labor Costs:
OverheadAmount Billed
Cumulative

0.00%

0.00%

Trave
Subcontracts
Consu tant Fees
Mater a s and Supp es
Other
Total Direct Costs
G&A Rate

0.00%

Subtota :F xed Fee

0.0%

Tota Amount C a med
Adjustments
Grand Total$
I cert fy that a payments requested are for appropr ate purposes and n accordance w th the contract.

Name/signature of signatory authority for invoicing

Contract Value

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58
ATTACHMENT #3

INSTRUCTIONS FOR COMPLETING"FINANCIAL REPORT OF INDIVIDUAL PROJECT/CONTRACT" GENERALINFORMATION
Purpose. This Quarterly Financial Report is designed to: (1) provide a management tool for use by be
BARDA in monitoring the application of financial and personnel resources to the BARDA contracts; (2)provide contractors with financial and personnel management data which is usable in their
management processes; (3) promptly indicate potential areas of contract underruns or overruns bymaking possible comparisons of actual performance and projections with prior estimates on individual
elements of cost and personnel; and (4) obtain contractor's analyses of cause and effect of significant
variations between actual and prior estimates of financial and personnel performance.
REPORTING REQUIREMENTS
Scope. The specific cost and personnel elements to be reported shall be established by mutual
agreement prior to award. The Government may require the contractor to provide detailed
documentation to support any element(s) on one or more financial reports.
Number of Copies and Mailing Address. An original copy of the report(s) shall be sent to the contracting
officer at the address shown on the face page of the contract, no later than 30 working
days after the end of the period reported. However, the contract may provide for one of the copies tobe sent directly to the Contracting Officer’s Technical Representative.
REPORTING STATISTICS
A modification which extends the period of performance of an existing contract will not require
reporting on a separate quarterly report, except where it is determined by the contracting officer that
separate reporting is necessary. Furthermore, when incrementally funded contracts are involved, eachseparate allotment is not considered a separate contract entity (only a funding action). Therefore, thestatistics under incrementally funded contracts should be reported cumulatively from the inception of
the contract through completion.
Definitions and Instructions for Completing the Quarterly Report. For the purpose of establishingexpenditure categories in Column A, the following definitions and instructions will be utilized. Eachcontract will specify the categories to be reported.
(1) Key Personnel. Include key personnel regardless of annual salary rates. All such individuals should
be listed by names and job titles on a separate line including those whose salary is not directly
charged to the contract but whose effort is directly associated with the contract. The listing must be
kept up to date.
(2) Personnel--Other. List as one amount unless otherwise required by the contract.

Contract No. HHSO100201800016C
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59(3) Fringe Benefits. Include allowances and services provided by the contractor to employees ascompensation in addition to regular salaries and wages. If a fringe benefit rate(s) has been
established, identify the base, rate, and amount billed for each category. If a rate has not been
established, the various fringe benefit costs may be required to be shown separately. Fringe
benefits which are included in the indirect cost rate should not be shown here.
(4) Accountable Personal Property. Include nonexpendable personal property with an acquisition costof $1,000 or more and with an expected useful life of two or more years, and sensitive items
regardless of cost. Form HHS 565, "Report of Accountable Property," must accompany thecontractor's public voucher (SF 1034/SF 1035) or this report if not previously submitted. See"Contractor's Guide for Control of Government Property."(5) Supplies. Include the cost of supplies and material and equipment charged directly to thecontract, but excludes the cost of nonexpendable equipment as defined in (4) above.
(6) Inpatient Care. Include costs associated with a subject while occupying a bed in a patient caresetting. It normally includes both routine and ancillary costs.
(7) Outpatient Care. Include costs associated with a subject while not occupying a bed. It normally
includes ancillary costs only.
(8) Travel. Include all direct costs of travel, including transportation, subsistence and miscellaneous
expenses. Travel for staff and consultants shall be shown separately. Identify foreign and domestic
travel separately. If required by the contract, the following information shall be submitted: (i)Name of traveler and purpose of trip; (ii) Place of departure, destination and return, including timeand dates; and (iii) Total cost of trip.
(9) Consultant Fee. Include fees paid to consultant(s). Identify each consultant with effort expended,billing rate, and amount billed.
(10) Premium Pay. Include the amount of salaries and wages over and above the basic rate of pay.
(11) Subcontracts. List each subcontract by name and amount billed.
(12) Other Costs. Include any expenditure categories for which the Government does not
require individual line item reporting. It may include some of the above categories.
(13) Overhead/Indirect Costs. Identify the cost base, indirect cost rate, and amount billed for eachindirect cost category.
(14) General and Administrative Expense. Cite the rate and the base. In the case of nonprofit
organizations, this item will usually be included in the indirect cost.
(15) Fee. Cite the fee earned, if any.
(16) Total Costs to the Government.

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PREPARATION INSTRUCTIONS
These instructions are keyed to the Columns on the Quarterly Report.
Column A--Expenditure Category. Enter the expenditure categories required by the contract.
Column B--Percentage of Effort/Hours Negotiated. Enter the percentage of effort ornumber of hours agreed to during contract negotiations for each labor category listed inColumn A.
Column C--Percentage of Effort/Hours-Actual. Enter the cumulative percentage of effort
or number of hours worked by each employee or group of employees listed in Column A.
Column D--Cumulative Incurred Cost at End of Prior Period. Enter the cumulative incurredcosts up to the end of the prior reporting period. This column will be blank at the time ofthe submission of the initial report.
Column E--Incurred Cost-Current Period. Enter the costs which were incurred during
the current period.
Column F--Cumulative Incurred Cost to Date. Enter the combined total of Columns D and E.
Column G--Estimated Cost to Complete. Make entries only when the contractor
estimates that a particular expenditure category will vary from the amount negotiated.
Realistic estimates are essential.
Column H--Estimated Costs at Completion. Complete only if an entry is made in Column G.
Column I--Negotiated Contract Amount. Enter in this column the costs agreed toduring contract negotiations for all expenditure categories listed in Column A.
Column J--Variance (Over or Under). Complete only if an entry is made in Column H.
When entries have been made in Column H, this column should show the difference
between the estimated costs at completion (Column H) and negotiated costs (Column I).
When a line item varies by plus or minus 10 percent, i.e., the percentage arrived at bydividing Column J by Column I, an explanation of the variance should be submitted. In thecase of an overrun (net negative variance), this submission shall not be deemed as noticeunder the Limitation of Cost (Funds) Clause of the contract.
Modifications. List any modification in the amount negotiated for an item since thepreceding report in the appropriate cost category.
Expenditures Not Negotiated. List any expenditure for an item for which no amount was
negotiated (e.g., at the discretion of the contractor in performance of its contract) in theappropriate cost category and complete all columns except for I. Column J will of courseshow a 100 percent variance and will be explained along with those identified under J
above.

ATTACHMENT #7

Statement of WorkF.

Independently, and not as an agent of the Government, the Contractor shall furnish all necessary services,qualified professional, technical, and administrative personnel, material, equipment and facilities, nototherwise provided by the Government under the terms of this contract, as needed to perform the tasks set
forth below.
BASE CONTRACT - Cue Health Monitoring System with Cue Influenza Cartridge and Cue Health Mobile App
and Cue Professional Mobile App
Objective
To accelerate the development, validation, regulatory authorization, and commercialization of the (b)(4)withprofessional point-of-care (POC)/CLIA Waived Cue Influenza Cartridge for use(b)(4)
the Cue Health Monitoring System and the Cue Health Mobile Application. Activities described herein will result in:• (b) (4)PROGRAM MANAGEMENT (WBS 1.1.1):
The Contractor shall provide for the following as outlined below:•

The overall management, integration and coordination of all contract activities, including atechnical and administrative infrastructure to ensure the efficient planning, initiation,
implementation, and direction of all contract activities;•

A principal investigator (PI) responsible for project management, communication, tracking, monitoring
and reporting on status and progress, and modification to the project requirements and timelines,
including projects undertaken by subcontractors; the contract deliverables list identifies all deliverables
and reporting requirements for this contract.

•

Project manager(s) responsible for monitoring and tracking day-to-day progress and timelines,
coordinating communication and project activities; costs incurred; and program activities.

•

A BARDA liaison responsible for effective communication with the project officer and contracting officer.

•

Administrative/legal staff to provide development of compliant subcontracts, consulting, and other legal
agreements, and ensure timely acquisition of all proprietary rights, including IP rights, and reporting all
inventions made in the performance of the project.

•

Administrative staff with responsibility for financial management and reporting on all activities
conducted by the contractor and any subcontractors.

ASSAY DEVELOPMENT (WBS 1.1.2):(b) (4)and valve optimization. Cue R&D will conduct
in-house analytical validation studies for the Cue Health Monitoring System and Cue Influenza Cartridge insupport of 510k (b) (4) POC/CLIA Waived clearance.
WBS/IMS Task 1.1.2.1: (b) (4)

WBS/IMS Task 1.1.2.2: Limit of Detection Study. Specific activities include prepare study protocol; prepare
sample panel; execute study; preparation and approval of study report (WBS
1.1.2.2.1 - 1.1.2.2.4). Deliverable is study report.
WBS/IMS Task 1.1.2.3: Qualify mucin matrix for sample panels and Demonstrate assay compatibility withdifferent nasal fluid properties. Evaluate various types of mucin for performance in Cue Influenza Cartridge.
Deliverable is approved study report. Specific activities include prepare study protocol; prepare sample
panel; execute study; preparation and approval of study report (WBS 1.1.2.3.1 - 1.1.2.3.4). Deliverable isstudy report.
WBS/IMS Task 1.1.2.4: Intra- and inter-assay precision and lot-to-lot agreement. Specific activities include
prepare study protocol; prepare sample panel; execute study; preparation and approval of study report(WBS 1.1.2.4.1 - 1.1.2.4.4). Deliverable is study report.
WBS/IMS Task 1.1.2.5: Analytical Reactivity (inclusivity) Studies. Specific activities include prepare study
protocol; prepare sample panel; execute study; preparation and approval of study report (WBS 1.1.2.5.1 1.1.2.5.4). Deliverable is study report.
WBS/IMS Task 1.1.2.6: Analytical Specificity (exclusivity and cross-reactivity) Studies. Specific activities
include prepare study protocol; prepare sample panel; execute study; preparation and approval of study
report (WBS 1.1.2.6.1 - 1.1.2.6.4). Deliverable is study report. WBS/IMS Task 1.1.2.7: Analytical
Specificity (potential interferents) Studies. Specific activities include prepare study protocol; prepare
sample panel; execute study; preparation and approval of study report (WBS 1.1.2.7.1 - 1.1.2.7.4).
Deliverable is study report.
WBS/IMS Task 1.1.2.8: Specimen Stability Study. Specific activities include prepare study protocol; prepare
sample panel; execute study; preparation and approval of study report (WBS
1.1.2.8.1 - 1.1.2.8.4). Deliverable is study report.
WBS/IMS Task 1.1.2.9: (b) (4)

WBS/IMS Task 1.1.2.10: Cartridge Stability Studies. Specific activities include prepare study protocol;
prepare sample panel; execute study; preparation and approval of study report (WBS
1.1.2.10.1 - 1.1.2.10.4). Deliverable is study report.
WBS/IMS Task 1.1.2.11: Cartridge Shipping Stability and Shipping Stress Studies. Specific activities include
Prepare study protocol; prepare sample panel; execute study; preparation and approval of study report(WBS 1.1.2.11.1 - 1.1.2.11.4). Deliverable is study report.
WBS/IMS Task 1.1.2.12: Milestone- Analytical Performance Studies completed.

CLINICAL (WBS 1.1.3):(b) (4)aIn support of 510k clearance for the professional POC/CLIA Waived claim, Cue will conduct clinical studies togenerate data for:•

Human Factors/Usability with professional operators simulating testing patients•

Repeatability/Reproducibility at external clinical sites (b) (4)•Detection of Samples at the Limit of Detection at clinical sites (b) (4)•Method Comparison of POC/CLIA Waived Cue Influenza to a predicate Influenza A/B NAT assay withprofessional trained and untrained operators testing enrolled subjects (includes parent testing his/herchild)

Further description of the studies that will be conducted as part of the clinical validation of Cue Influenza
at external clinical sites is presented below.
WBS/IMS Task 1.1.3.5: (b) (4)(b) (4)WBS/IMS Task 1.1.3.6: Clinical Study Protocols, Statistical Analysis Plans, Data Management Plans andeDatabase.(
Waived Method Comparison,b
Reproducibility/Repeatability Study, and Samples at LoD Study Protocols (WBS 1.1.3.6.1); preparation of
Statistical Analysis Plans (WBS 1.1.3.6.2); preparation of Data Management Plans(DMPs) and eDatabases(WBS 1.1.3.6.3 – 1.1.3.6.4). (b) (4)and POC/CLIA Waived Method
Comparison, Reproducibility/ Repeatability Study, and Samples at LoD Study Protocols, SAPs, and DMPs,
and live eDatabases. WBS/IMS Task 1.1.3.7 – 1.1.3.8: Clinical Study Site and Central Lab Qualification and
Selection for Method Comparison, Reproducibility/Repeatability, and Samples at LoD Studies. Specificactivities include: development of site feasibility questionnaire, identification of potential sites, executionof non-disclosure agreement with potential investigators, conduct site qualification visits and reporting(WBS 1.1.3.7.1 – 1.1.3.7.8 and WBS 1.1.3.8.1 – 1.1.3.8.8).(b) (4)

WBS/IMS Task 1.1.3.9: Clinical Study Site Contracts. Specific activities include: draft budgets and budget
negotiation (WBS 1.1.3.9.1); draft contract and contract negotiations (WBS 1.1.3.9.2). Deliverables areclinical study contracts executed with clinical sites and central lab.
WBS/IMS Task 1.1.3.10: Institutional Review Board (IRB) Submissions and Approvals of Each Clinical
Validation Protocol. Specific activities include: selection of IRB, completion of IRB protocol submission
forms, draft informed consent forms, and submission and approval of method comparison study
protocols and informed consent forms (WBS 1.1.3.10.1 – 1.1.3.10.4).Deliverables are IRB approval (b) (4)
POC/CLIA Waived Method Comparison, Reproducibility/Repeatability Study, and Samples at LoD
Protocols.
WBS/IMS Task 1.1.3.11: Clinical Study Materials. Specific tasks include: ship Cue IUO devices, mobile
smart devices, predicate devices and sample collection kits procurement and accountability at clinicalsites (WBS 1.1.3.11.1 – 1.1.3.11.7). Deliverables are all clinical study materials at the clinical sites.
WBS/IMS Task 1.1.3.12: Clinical Site Initiation. Specific tasks include: preparation of Clinical Monitoring
Plans, set up of Trial Master Files and Investigator Site Binders, creation of study- specific forms, conduct
initiation visits and preparation and approval of initiation visit reports (WBS 1.1.3.12.1; 1.1.3.12.2.1 –
1.1.3.12.2.12). Deliverables are clinical sites initiated.
WBS/IMS Task 1.1.3.13.1 – 1.1.3.13.4: Clinical Sites Reproducibility/Repeatability Study Conducted andReported. This study will demonstrate the reproducibility and repeatability of the Cue Influenza Cartridge
assay. This study will be conducted at 3 external CLIA Waived clinical sites with 6 trained professional
operators using identical panel members. The sample panel will contain 10 panel members. Two strains ofinfluenza A virus and 1 strain of influenza B virus will be used to build the panel members. The influenza A
virus panel members will contain high negative (<LoD; C20-80), low positive (LoD; C95), and moderate
positive (2-3x LoD; C 00 ) concentrations. The influenza B virus panel members will contain high negative(<LOD; C20-80), low positive (LoD; C95), and moderate positive (2-3x LoD; C 00 ) concentrations. One panel
member will be negative for influenza A and B viruses. At each site, 2 operators per day will conduct

preparation of study report (WBS 1.1.3.14.4.1 – 1.1.3.14.4.5). Deliverable is method comparison study
report.
WBS/IMS Task 1.1.3.15: BIMO Inspections. Specific activities include clinical site and Cue
preparation and mock inspections (WBS 1.1.3.15.1 – 1.1.3.15.2). Deliverable is mock BIMO
inspections completed.
REGULATORY (WBS 1.1.4):
WBS/IMS Tasks 1.1.4.1 – 1.1.4.3: Regulatory Submissions. Preparing and submitting FDA 510k for Cue
Influenza (b) (4)
FDA 510(k) for Cue Influenza POC/CLIA Waived claim.
Deliverables are FDA 510k(b) (4)
POC/CLIA Waived submissions and clearances.
BIOPRODUCTION MANUFACTURING (WBS 1.1.5):(b) (4)(WBS 1.1.5.3.1 – 1.1.5.3.5). Deliverable is process transfer protocol.
WBS/IMS 1.1.5.4: (b) (4)

WBS/IMS 1.1.5.5 Bioproduction scale up for post 510k commercialization.

CARTRIDGE MANUFACTURING (WBS 1.1.6):
Cartridge Automation Manufacturing activities include automation system design, approval, fabricationof manufacturing systems, validation of cartridge automation line and manufacture of Cue Influenza
Cartridges for analytical and clinical (b) (4)

WBS/IMS 1.1.6.1: (b) (4)Work completed to date on the automation line. Deliverable is functional cartridge assembly
equipment.
WBS/IMS 1.1.6.2: Create system level drawings for each automation system/machine.
Deliverable is completed system-level drawing for each automation machine.
WBS/IMS 1.1.6.3: Write specification for each automation machine. Deliverable is system- levelspecifications for each automation machine.
WBS/IMS 1.1.6.4: Project approval for each system. Deliverable is documented project approval foreach system.
WBS/IMS 1.1.6.5: Successful Design Review for Each System. Deliverable is documented design review
and approval completed for each system.
WBS/IMS 1.1.6.6: Install Dry Room System for Manufacturing Cell. Deliverable is documented validation fordry room performance.
WBS/IMS 1.1.6.7: Fabrication of Each System (mechanical, electrical, pneumatics).
Deliverable is fabrication of each system is completed.
WBS/IMS 1.1.6.8: Initial Debug of Each System (able to produce a single part).
Deliverable is each system debug is completed.
WBS/IMS 1.1.6.9: Full System Runs-Optimize and Final Debug. Deliverable is optimization and final debug
completed.
WBS/IMS 1.1.6.10: Documentation for Each System (e.g., Operation & Maintenance Manual, Spare Parts
List). Deliverable is documentation for each system is complete.
WBS/IMS 1.1.6.11: Validation Protocols for Each System. Deliverable is approved validation protocols foreach system.
WBS/IMS 1.1.6.12: Validate all Systems (IQ, OQ, PQ). Deliverable is IQ, OQ, PQ complete and reportapproved for each system.
WBS/IMS 1.1.6.13: Manufacture of Cue Influenza Cartridges for analytical and clinical validation.
Manufacture of 3 lots of Cue Influenza Cartridges for analytical and clinical validation. WBS/IMS 1.1.6.14:
Manufacture scale up to meet cartridge sales post FDA 510(k) clearance
WBS/IMS 1.1.7: Quality: Maintenance of ISO 13485 certification, quality audits, instrument
calibrations, QA and release batch records, oversee building and lab monitoring systems.
WBS/IMS 1.1.8 Operations: ERP, purchasing, supply chain and inventory management,
production/quality team coordination
WBS/IMS 1.1.9 Software: Develop testing systems for iOS consumer and professional apps, software
verification/validation/documentation, automated testing to ensure working order maintenance of

backend systems. Deliverable is validated Cue consumer and professional apps and ongoing software
lifecycle documentation.
OPTION 1: Cue Health Monitoring System with Cue Multiplex Respiratory Pathogen Cartridge and Cue
Health Mobile App
Objective
The Cue Multiplex Respiratory Pathogen Cartridge will be a multiplex assay that will detect and differentiate
influenza A and B viruses, as well as Influenza A subtypes (eg, H3N2 and H1N1) and detect respiratorysyncytial virus (RSV) and human coronavirus (HCoV). To accelerate the development, validation, regulatory
authorization, and commercialization of the(b) (4)Respiratory Pathogen Cartridge for use with
the Cue Health Monitoring System and the Cue Health Mobile App (b) (4)Activities described herein
will result in:•

510k submission for the Cue Health Monitoring System with OTC Cue Multiplex Respiratory
Pathogen Cartridge in September 2020•

Expected 510k clearance and commercial availability in February 2021

PROJECT MANAGEMENT (WBS 1.2.1 Project Management)
Overall management, integration and coordination of all contract activities; technical and administrative
infrastructure (WBS 1.2.1.1).
ASSAY DEVELOPMENT (WBS 1.2.2 Multiplex Respiratory Pathogen Assay Development) Assay development
activities conducted under this proposal will include assay feasibility, primer screening and buffer
optimization, as well as development and optimization of the amplification protocol through the piezo andmultiplex detection. In addition, analytical performance verification and validation studies will be conductedin-house to validate characteristics of the Cue Health Monitoring System with Cue Multiplex Respiratory
Pathogen Cartridge.
WBS/IMS Task 1.2.2.1 – 1.2.1.2: (b) (4)

WBS/IMS Task 1.2.2.3: Design Verification Studies and Reporting. Specific tasks include: preparation of
study protocols, execution of studies and preparation of study reports for limit of detection, precision,
specificity, potentially interfering substances, specimen matrices, and cartridge stability performance
characteristics (WBS 1.2.2.3.1 - 1.2.2.3.5). Deliverable is study reports.
WBS/IMS Task 1.2.2.4: Analytical Performance Validation and Reporting. Specific tasks include:
preparation of study protocols, execution of studies and preparation of study reports for limit of detection
specimen matrices precision analytical specificity (exclusivity), analytical reactivity (inclusivity), lot-to-lot
agreement, potentially interfering substances, specimen stability, cartridge stability, flex studies, cartridge
shipping stability (WBS 1.2.2.4.1 - 1.2.2.4.10). Deliverable is study reports.

CLINICAL (WBS 1.2.3)
In support of the 510k clearance (b) (4) Cue Multiplex Respiratory Pathogen Cartridge, Cue will conductclinical studies at external sites to generate data for:• (b) (4)• Repeatability/Reproducibility• Detection of Samples at the Limit of Detection• Method Comparison of Cue Multiplex Respiratory Pathogen Cartridge to a reference method(s)(b) (4)Further description of the studies that will be conducted as part of the external site clinical validation of
the Cue Multiplex Respiratory Pathogen Cartridge is presented in the following WBS/IMS tasks.
WBS/IMS 1.2.3.1-1.2.3.3: Clinical Plan and IUO Labeling. Specific activities include: pre- submission to FDA
and FDA feedback provided to Cue, Regulatory and Clinical Plans, collaboration on draft IUO Cue Multiplex
Respiratory Pathogen Cartridge labeling. Deliverables are completed and approved regulatory and clinicalplans and IUO labeling complete.
WBS/IMS 1.2.3.4: Vendor Selection and Engagement. Specific activities include: CRO qualification andselection, budget negotiation, contract executed and CRO training (WBS 1.2.3.6.1); eDC (electronic data
capture system/eDatabase) vendor qualification and selection, budget negotiation, contract execution eDC(WBS 1.2.3.6.2). Deliverables are CRO/eDatabase vendor(s) contracted and engaged.
WBS/IMS 1.2.3.5: Human Factors/Usability Studies. (b) (4)

WBS/IMS 1.2.3.6: Clinical Study Protocols, SAPs, Data Management Plans, eDatabases. Specific tasks
include: preparation of separate protocols for Method Comparison, Reproducibility/Repeatability,
Samples at LoD studies (WBS 1.2.3.6.1); preparation of Statistical Analysis Plans (WBS 1.2.3.6.2);
preparation of Data Management Plans(DMPs) and eDatabases (WBS 1.2.3.6.3 – 1.2.3.6.4). Deliverables
are internal approval of the protocols for the Method Comparison Study, Reproducibility/ Repeatability
Study, and Samples at LoD Study, SAPs, and DMPs, and live eDatabases.
WBS/IMS 1.2.3.7 – 1.2.3.8: Clinical Study Sites/Central Lab Qualification. Specific activities include:
development of site feasibility questionnaire, identification of potential sites, execution of non-disclosureagreement with potential investigators, conduct site qualification visits and reporting (WBS 1.2.3.7.1 –1.2.3.7.8, WBS 1.2.3.8.1 – 1.2.3.8.8). Deliverables are at least 8 clinical sites and 1 central lab selected.
WBS/IMS 1.2.3.9: Clinical Study Site Contracts. Specific activities include: draft budgets and budget
negotiation (WBS 1.2.3.9.1); draft contract and contract negotiations (WBS 1.2.3.9.2).

Deliverables are clinical study contracts executed with clinical sites and central lab. Deliverables are clinicalstudy contracts executed with clinical sites and central lab.
WBS/IMS Task 1.2.3.10: Institutional Review Board (IRB) Submissions and Approvals. Specific activities
include: selection of IRB, completion of IRB protocol submission forms, draft informed consent forms, andsubmission and approval of method comparison study protocols and informed consent forms (WBS
1.2.3.10.1 – 1.2.3.10.6). Deliverables are IRB approval of Method Comparison,
Reproducibility/Repeatability Study, and Samples at LoD Protocols.
WBS/IMS Task 1.2.3.11: Clinical Study Materials. Specific tasks include: ship Cue IUO devices, mobile
smart devices, predicate devices and sample collection kits procurement and accountability at clinicalsites (WBS 1.2.3.11.1 – 1.2.3.11.11). Deliverables are all clinical study materials at the clinical sites.
WBS/IMS Task 1.2.3.12: Clinical Site Initiation. Specific tasks include: preparation of Clinical Monitoring
Plans, set up of Trial Master Files and Investigator Site Binders, creation of study- specific forms, conductsite initiation visits and preparation and approval of initiation visit reports (WBS 1.2.3.12.1 – 1.2.3.12.2).
Deliverables are clinical sites initiated.
WBS/IMS Task 1.2.3.13.1 – 1.2.3.13.4: Reproducibility/Repeatability Studies. This study will demonstrate
the reproducibility and repeatability of the Cue Multiplex Respiratory Pathogen Cartridge at external clinicalsites. The study will be conducted at 3 external sites with trained professional operators using identical
panel members. A 13-member sample panel will be prepared in a simulated nasal swab sample matrix. One
panel member will be negative for influenza A, influenza B, RSV and HCoV. The positive panel members willcontain these viruses at high negative (C20-80), low positive (C95), and moderate positive (2-3x LoD)
concentrations. Each positive panel member will contain only one type of virus (eg, influenza A or influenza
B or RSV or HCoV). At each site, 2 operators per day will conduct testing. Each operator will test 3 replicatesof each sample panel member per run. Each site will conduct testing for 5 days. Each site will generate 30
results per sample for a total of 90 results per sample overall. Specific activities include study execution(WBS 1.2.3.13.1); database lock and data review and analysis (WBS 1.2.3.13.2); study close-out (WBS
1.2.3.13.3; 1.2.3.13.7), preparation of study report (WBS 1.2.3.13.4). Deliverable is the study report.
WBS/IMS Subtasks 1.2.3.13.5 – 1.2.3.13.8: Clinical Sites Testing of Samples with Concentrations near the
LoD. This study will demonstrate the performance of the Cue Multiplex Respiratory Pathogen Cartridgewith untrained professional users testing samples with near the LoD. The study will be conducted at 3
external CLIA Waived clinical sites. For influenza A, influenza B, RSV or HCoV concentrations sample panels,
Cue will prepare a contrived weak positive (C95) sample pool and a contrived weak negative (C5) sample
pool in a simulated nasal swab sample matrix. The aliquots of the pools will be distributed (minimum
10/operator) to the sites for testing. Two untrained operators at each site will conduct testing. The percent
of positive results with Cue Multiplex Respiratory Pathogen Cartridge for the weak positive samples andthe percent of negative results for the weak negative samples will be calculated overall and by site. Specificactivities include study execution (WBS 1.2.3.13.5); database lock and data review and analysis (WBS
1.2.3.13.6); study close-out (WBS 1.2.3.13.7), preparation of study report (WBS 1.2.3.13. 8). Deliverables is
the Samples at LoD study report.
WBS/IMS Task 1.2.3.14: Clinical Performance/Method Comparison Study (b) (4)(b) (4)Waiver Applications for Manufacturers of In Vitro Diagnostic Devices,” “Establishing the Performance
Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza
Viruses,” “Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A
Virus Subtypes Using Multiplex Nucleic Acid Assays”, “Guidance for Industry and Food and Drug Administration
Staff: Applying Human Factors and Usability Engineering to Medical Devices” and applicable FDA regulations.
This prospective, non-interventional clinical performance study will be conducted at approximately 8 US clinicalsites.(b) (4)The overall sample size of 2000 subjects is dependent on the prevalence of influenza viruses, RSV, and
HCoV which vary by season. The overall sample size is approximately 2,000 subjects to obtain a minimum of 120
samples with positive results for influenza A, 120 samples with positive results for influenza B, approximately 40
samples with positive RSV results, and 40 samples with positive human coronavirus results as determined by
the reference method. The overall sample size assumes that influenza B and coronaviruses will have the lowest
prevalence, assuming 6% for influenza B and 2% for human coronaviruses. Cue Multiplex Respiratory Pathogen
Cartridge results will be compared to the predicate method(s) (eg, respiratory panel NAAT assay) and sensitivity
and specificity of the Cue Multiplex Respiratory Pathogen Cartridge test will be calculated. Specific tasks
include: execution and reporting of the method comparison study (WBS 1.2.3.14.1 – 1.2.3.14.4).
Deliverable is the clinical study report.
WBS/IMS Task 1.2.3.15: BIMO Inspections. Specific activities include clinical site and Cue
preparation and mock inspections (WBS 1.1.3.15.1 – 1.1.3.15.2). Deliverable is mock BIMO
inspections completed.
REGULATORY (WBS 1.2.4):
WBS/IMS Tasks 1.2.4.1 – 1.2.4.3: Regulatory Submissions.
Preparing and submitting FDA Pre-submissions for(b) (4)Multiplex Respiratory Pathogen Cartridge (WBS
1.2.4.1); preparing and submitting FDA 510k submission for (b) (4) Multiplex Respiratory Pathogen Cartridge(WBS 1.2.4.2). Deliverables are FDA 510k submission and clearance.
BIOPRODUCTION MANUFACTURING (WBS 1.2.5):(b) (4)

WBS/IMS 1.2.5.1: (b) (4)(b) (4)WBS/IMS 1.2.5.2: (b) (4)

WBS/IMS 1.2.5.3: (b) (4)

WBS/IMS 1.2.5.4: Lyophilization Process Transfer and Validation. After 3 successful pre-production lots oflyophilization pellets are made, the lyophilization process validation will be completed. After the completion oflyophilization validation, the lyophilization process will be integrated into the automation line to support
manufacturing of Cue Multiplex Respiratory Pathogen Cartridges for analytical and clinical validation. Specificactivities include preparation of internal certificate of analysis for production lots, preparation of processtransfer protocol, and transfer to GMP. The validation protocols for the lyophilization process will be preparedand IQ, OQ, and PQ validation efforts will be completed. Critical process parameters will be identified through
FMEA risk assessments (WBS 1.2.5.4.1 – 1.2.5.4.8).
Deliverable is the lyophilization validation report.
WBS/IMS 1.2.5.5 Bioproduction scale-up for post 510k commercialization.
CARTRIDGE AUTOMATION MANUFACTURING (WBS 1.2.6):
Cartridge Automation Manufacturing activities include automation system design, approval, fabrication of
manufacturing systems, validation of cartridge automation line and manufacture of Cue Influenza
Cartridges for analytical and clinical validation. (b) (4)

WBS/IMS 1.2.6.1: Create system level drawings for each automation system/machine.
Deliverable is completed system-level drawing for each automation machine.
WBS/IMS 1.2.6.2: Write specification for each automation machine. Deliverable is system- levelspecifications for each automation machine.
WBS/IMS 1.2.6.3: Project approval for each system. Deliverable is documented project approval foreach system.
WBS/IMS 1.2.6.4: Successful Design Review for Each System. Deliverable is documented design review
and approval completed for each system.
WBS/IMS 1.2.6.5: Install Dry Room System for Manufacturing Cell. Deliverable is documented validation fordry room performance.
WBS/IMS 1.2.6.6: Fabrication of Each System (mechanical, electrical, pneumatics).

Deliverable is fabrication of each system is completed.
WBS/IMS 1.2.6.7: Initial Debug of Each System (able to produce a single part).
Deliverable is each system debug is completed.
WBS/IMS 1.2.6.8: Full System Runs-Optimize and Final Debug. Deliverable is optimization and final debug
completed.
WBS/IMS 1.2.6.9: Documentation for Each System (e.g., Operation & Maintenance Manual, Spare Parts
List). Deliverable is documentation for each system is complete.
WBS/IMS 1.2.6.10: Validation Protocols for Each System. Deliverable is approved validation protocols for eachsystem.
WBS/IMS 1.2.6.11: Validate all Systems (IQ, OQ, PQ). Deliverable is IQ, OQ, PQ complete and reportapproved for each system.
WBS/IMS 1.2.6.12: Manufacture of Cue Multiplex Respiratory Pathogen Cartridge for analyticaland clinical validation. Manufacture of 3 lots of Cue Multiplex Respiratory Pathogen Cartridge
for analytical and clinical validation.
WBS/IMS 1.2.6.13: Manufacture scale up to meet cartridge sales post FDA 510(k) clearance WBS/IMS
1.2.7: Quality: Maintenance of ISO 13485 certification, quality audits, instrument calibrations, QA andrelease batch records, oversee building management

WBS/IMS 1.2.8 Operations: ERP, purchasing, supply chain and inventory management,
production/quality team coordination.
WBS/IMS 1.2.9 Software: Develop testing systems for iOS consumer and professional apps,
software verification/validation/documentation, automated testing to ensure working ordersystems. Deliverable is validated Cue consumer and professional apps and ongoing software
lifecycle documentation.

ATTACHMENT #8

Background Inventions

The following table provides a list of inventions which may be used in the performance of thecontract but to which the Government shall have no rights because they were developed at
private expense prior to the effective date of the contract (the “Background Inventions”):
Patent/Application No

Publication Date(b) (4)Title

analytes(b) (4)

For purposes of FAR 52.227-14, Rights in Data, Alt II, all unpublished data pertaining to the above
Background Inventions that is not first produced in the performance of the contract shall be considered“limited rights data.”