Technical Volume

Technical Volume
Biomedical Advanced Research and Development Authority (BARDA)
Letter Request for Proposal No. 75A50120R00029

ADVIA Centaur SARS-CoV-2 Total , Atellica IM
SARS-CoV-2 Total(COV2T)
Statement of Work (SOW)Preamble
Independently, and not as an agent of the government, the contractor shall furnish all necessary
services; qualified professional, technical, and administrative personnel; and material, equipment, andfacilities not otherwise provided by the government under the terms of this contract, as needed toperform the tasks set forth below.
The government reserves the right to modify the budget, progress, schedule, or milestones to add ordelete processes, schedules, or deliverables if the need arises. Because of the nature of this research anddevelopment (R&D) contract and the complexities inherent in this and prior programs, at designatedmilestones the government will evaluate whether work should be redirected or removed, or whether
schedule or budget adjustments should be made. The government reserves the right to change theproduct, process, schedule, or events to add or delete part or all of these elements as the need arises.
Background
The assay developed under the tradename SARS-Cov-2 Total assay is an EUA in vitro diagnostic test
available on the Siemens ADVIA Centaur® XP and XPT analyzers, which can test up to 240 samples perhour, with a result in 18 minutes; and on the Atellica® Solution immunoassay platform, which can test up
to 440 samples per hour, with a result in just 10 minutes. Siemens Healthineers has over 2,000
immunoassay systems installed in the U.S., across all 50 states, and has shipped over 500,000 COV2T
tests since May 22, 2020. Siemen has over 12,000 immunoassay systems distributed globally and has
shipped 7 million tests globally since May 22, 2020.
On May 30, 2020 Siemens Healthineers received EUA approval for the SARS-CoV-2 total antibody test foruse on the ADVIA Centaur and Atellica IM systems. This project has been funded in whole or in part with
Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for
Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA),Division of Research Innovation and Ventures under Contract No. 75A50120C00111.
In response to Letter Request for Proposal No. 75A50120R00029, Siemens has prepared the following
technical and separate business volumes. Siemens would like to note a change to the US install base in
Attachment 1 from 20,000 to 2,000 immunoassay systems.

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Overall Objectives and Scope
The objective of this contract is to submit a 510(k) application to the FDA for the SARS-CoV-2 Total(COV2T) assay for use on the ADVIA Centaur XP/XPT, ADVIA Centaur CP, Atellica IM 1300, and Atellica IM
1600 systems (b) (4)Siemens willcontinue the product development in response to user feedback, disease understanding, FDA guidance
via 510(k) pre-submission; and clinical evaluations COV2T EUA product.
The following Milestones will encompass project deliverables, success criteria and timelines.
Project Milestones:
Milestone 1
XPT, ADVIA Centaur CP, Atellica IM 1300 and Atellica IM 1600 platform
Milestone 2
Centaur XPT, ADVIA Centaur CP, Atellica IM 1300 and Atellica IM 1600 platform
Milestone 3
ADVIA Centaur XP, ADVIA Centaur XPT, ADVIA Centaur CP, Atellica IM 1300 and Atellica IM 1600
platform
Milestone 4
SARS-Cov-2 Total 510 (k) product
Milestone 5
Milestone 6
Milestone 1: Feasibility of SARS-CoV-2 Total 510 (k) product on the ADVIA Centaur XP, ADVIA Centaur XPT,ADVIA Centaur CP, Atellica IM 1300 and Atellica IM 1600 platform
Objective:
Complete feasibility testing of 510(k) product on all platforms and provide a pre-submission report to the
FDA.
Scope of Work:
Completion of product intended use, product design input requirements, and feasibility testing for semiquantitative assay: LOB, LOD, LOQ, linearity, on-board dilution, sensitivity and specificity with retrospective
samples. Sample acquisition and banking will be executed to ensure product verification and intended use aremet.
Success Criteria for Completion of Milestone 1:
Feasibility of the SARS-CoV-2 Total 510 (k) assay on the ADVIA Centaur XP, ADVIA Centaur XPT, ADVIA
Centaur CP, Atellica IM 1300 and Atellica IM 1600 platform. Feasibility testing meets design input
requirements and sample banking is secured to ensure product meets verification and intended use and/or
the phase ends with the 510(k) product pre-submission to the FDA.

Milestone 2: Design Verification of SARS-CoV-2 Total 510 (k) product on the ADVIA Centaur XP, ADVIA
Centaur XPT, ADVIA Centaur CP, Atellica IM 1300 and Atellica IM 1600 platform
Objective:
Complete defined verification studies required for FDA 510(k) product submission.
Scope of Work:
Verification activities demonstrates the final design prototype meets design inputs on all immunoassay

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platforms. Verification testing includes cross-reactivity, environmental studies, reagent on-board dilution,
sample handling/stability.
Success Metric for Completion of Milestone 2:
Design verification of the SARS-CoV-2 Total 510 (k) assay on the ADVIA Centaur XP, ADVIA Centaur XPT,ADVIA Centaur CP, Atellica IM 1300 and Atellica IM 1600 platform. Verification testing meets design input
requirements and the phase ends with completion of the deliverable reports.

Milestone 3: Verification of SARS-CoV-2 Total 510 (k) product on board and shelf life stability on the
ADVIA Centaur XP, ADVIA Centaur XPT, ADVIA Centaur CP, Atellica IM 1300 and Atellica IM 1600
platform
Objective:
Plan and execute shelf life stability and on-board stability verification for all COV2T products across all
systems.
Scope of Work:
Testing includes reagent, calibrators and quality control material shelf life testing to 24 months or failure,
whichever comes first. On-board stability testing for reagents and diluents is (b) (6). Testing performed on all immunoassay systems.
Success Metric for Completion of Milestone 3:
Complete shelf life testing and on-board stability testing. Complete a report demonstrating stability design
inputs are met.

Milestone 4: Execution of Clinical Evaluations for the SARS-Cov-2 Total 510 (k) productObjective:
Demonstrate design validation of the SARS-Cov-2 Total 510 (k) product.
Scope of Work:
Prospective and retrospective sample collections for design verification of the 510(k) product consistent with
FDA product pre-submission (in Milestone 1) and product intended use. Identification of clinical andperformance evaluation sites. Finalize clinical evaluation protocol, and execute clinical evaluation, complete
data analysis and report.
Success Metric for Completion of Milestone 4:
Execution of the clinical evaluations, completion of data analysis and clinical evaluation report.
Demonstration design inputs meet design outputs.

Milestone 5: Design Transfer to Manufacturing for the SARS-Cov-2 Total 510 (k) productObjective:
Ensure successful transfer of the COV2T 510(k) product to the manufacturing site.
Scope of Work:
Includes design transfer plan and report, process and material risk report, and demonstrate scalable productmanufacture.
Success Metric for Completion of Milestone 5:

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Completion of product transfer to manufacturing environment.

Milestone 6: Submission of the SARS-Cov-2 Total 510 (k) product FDA product claims and labeling
Objective:
Submit the 510(k) product technical file, packaging, and labeling to the FDA.
Scope of Work:
Completion of milestones 1-5. Product technical report and product packaging and labeling and.
Success Metric for Completion of Milestone 6:
Submission and acknowledgement of receipt from FDA.
Management of this Project
The Product Development Process (PDP) at Siemens Healthcare LD is an organized, structured approach to
product development, integrating design control and business aspects. It is intended to ensure that the end
product meets its design objectives and is technically sound, manufacturable, serviceable, safe and effective,
and meets business needs, intended use, and user needs.
A PDP project is managed by the Core Team (a multi-functional group empowered to manage the developmentof a product). The Core Team Leader (the general manager of the project) is responsible for leading the(DHF).
Design Reviews are formal, scheduled, comprehensive, documented, and systematic examinations of a design
to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet theserequirements, and to identify design problems. They are planned and conducted at appropriate stages of
product development. The deliverables to be reviewed at each Design Review and their functional owners are
The outcomes from the Design Reviews are documented
in the Design Review Record and the action items identified during the Design Reviews are tracked forcompletion.
Milestones provide a venue for Core Teams to present to the Product Life Cycle Management (PLM) theirreadiness to enter the next PDP phase, which includes the completion of the planned reviews and deliverables
for the current phase. Milestone approval includes the timeline, scope, resources, and funding to complete thedeliverables for the next phase.
Product Life Cycle Management (PLM) is a senior-level management group that represents the operational
functions within the organization. PLM has specific authority to fund, approve, redirect, put on-hold, or cancel
product development projects. The PLM advises the Core Team in order to achieve the proper balance between
schedule, cost, and features (including robustness and performance) during all phases of product development.
The PLM ensures the Core Team maintains an uncompromising adherence to the Quality Management System(QMS).

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A. CONTRACTING OFFICER
The following CO will represent the Government for the purpose of this Contract:(b) (6)The CO is the only individual who can legally commit the Government to the expenditure of
public funds. No person other than the CO can make any changes to the terms, conditions,general provisions, or other stipulations of this Contract.
The CO is the only person with the authority to act as agent of the Government under thiscontract. Only the CO has authority to (1) direct or negotiate any changes in the Statement ofWork; (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 thisContract; and (5) otherwise change any terms and conditions of this Contract.
No information other than that which may be contained in an authorized modification to thisContract, duly issued by the CO, which may be received from any person employed by theGovernment, otherwise, shall be considered grounds for deviation from any stipulation of thisContract.
The Government may unilaterally change its CO designation, after which it will notify theContractor in writing of such change.

The following Contracting Officer's Representative (COR) will represent the Government for the
purpose of this contract:(b) (6)The COR is responsible for: (1) monitoring the Contractor's technical progress, including thesurveillance and assessment of performance and recommending to the Contracting Officerchanges in requirements; (2) 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; and (5) assisting in the
resolution of technical problems encountered during performance.
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 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 for any costs incurred
during the performance of this contract; (5) otherwise change any terms and conditions of thiscontract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated
by reference in Section K of the contract
The Government may unilaterally change its COR designation.

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Contract Number:
C. INVOICING
1. Invoices will be submitted for each deliverable in accordance with the agreed upon
payment schedule. In the event that a deliverable is not submitted or not deemed
acceptable for approval by the COR and CO, the CO reserves the right to not process theinvoice and payment until an acceptable deliverable has been submitted and approvedby the COR and CO.
2. Invoices must include the cumulative total expenses to date, adjusted (as applicable) toshow any amounts suspended by the Government.
3. The Contractor shall submit an electronic copy of the payment request to the approving
official instead of a paper copy. The payment request shall be transmitted as an
attachment via e-mail to: PSC Invoices@psc.hhs.gov, the Contracting Officer, and theD. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE
1. Contractor Performance Evaluations
A final evaluation of Contractor performance will be prepared on this contract inaccordance with FAR Subpart 42.15 at the time of completion of work.
The final evaluation will be provided to the Contractor as soon as practicable after
completion of the evaluation. The Contractor will be permitted fourteen 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 anindividual one level above the Contracting Officer, whose decision will be final.
A copy of the evaluation, Contractor response, and review comments, if any, will be
retained as part of the contract file, and may be used to support future award decisions.
2. Electronic Access to Contractor Performance Evaluations
Contractors may access evaluations through a secure Web site for review and comment
at the following address: http://www.cpars.gov.

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Contract Number:
If corrective action
is recommended,
Contractor must
address anddocument allconcerns raised by
BARDA.
6

Work Location Tracking

The Contractor shall submit a detailed
spreadsheet regarding locations where
work will be performed under this contract,
including addresses, points of contact, andwork performed per location, to include
any subcontractors, if necessary.

Within 5 businessdays of award date,
and within 30 days
after substantive
changes are madeto locations orcapabilities.
Within 2 businessdays of a
substantive change
if the work
performed supports
medicalcountermeasuredevelopment that
addresses a threatthat has been
declared a Public
Health Emergency
by the HHS
Secretary or a Public
Health Emergency
of International
Concern (PHEIC) by
the WHO.

7

Pandemic Management
Plan

A pandemic facility and/or operational
management plan including change
procedures from normal to pandemic
operations Contractor will prepare an
operational plan to continue operations in
the event of a declared pandemic
emergency.

Draft within 15 daysof award. Final
within 30 days ofaward.

8

Product/Technology
Transition Strategy

Contractor shall provide a 1-2 page
summary document containing a Transition
Strategy. The Transition Strategy should
provide a strategic business and technicalplan for further development andContractor shallprovide theTransition Strategy
30 days prior to the

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Contract Number:

9

Final Data Submission
Packagetransitioning the product and/or
technology.

end of each year of
the Base Period.

Contractor must submit a data package
consisting of all raw data produced under
this contract. Data may be used by BARDA
for analysis, evaluation, shared with otheragencies, or shared outside of thegovernment consistent with FAR 52.227-14.
This submission package must be delivered
in a non-proprietary format.

Contractor willsubmit at least 15
days prior tocontract end date.
Partial data-sets
may also berequested fordelivery prior to
submission of the
Final Data
Submission
Package.

If clinical trial data is included, that data
must be provided consistent withapplicable privacy laws to protect
personally identifiable information (PII).
10

Draft Final Report &Final Report

These reports are to include a summationof the work performed and results obtained
for the entire contract period of
performance.

Draft Final Report to
the COR and CO 30
calendar days prior
to contract end
date; Final Reportshall be deliveredon or before thecompletion date of
the contract.

11

Supplemental TechnicalDocuments, Raw Data,or Data Analysis

The Contractor shall provide all raw data,
data analysis, or a data report to BARDA in
accordance with FAR 52.227-14.

Contractor shallprovide theTechnical
Documents, Raw
Data, or Data
Analysis uponrequest from the CO
or COR.

12

Deliverables Arisingfrom FDA
Correspondence

See descriptions below for FDA Meetings,
FDA Submissions & Correspondence, FDA
Audits, and Other FDA Correspondence.

See descriptions
below for FDA
Meetings, FDA
Submissions &Correspondence,
FDA Audits, andOther FDA
Correspondence.

13

Invention Reporting
Requirements

All reports and documentation required by
FAR Clause 52.227-11 Patent Rights-

On or before
contract closeout.

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Contract Number:
Ownership by the Contractor, including, but
not limited to, the invention disclosure
report, the confirmatory license, and theGovernment support certification, and a
copy of the final invention statement, shallbe submitted to the CO. A final invention
statement (see FAR 27.303 (b)(2)(ii)) shallbe submitted to the CO prior to thecloseout of the Contract.

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Contract Number:

A. ENGAGEMENT WITH THE U.S. FOOD AND DRUG ADMINISTRATION (FDA)
1. FDA Meetings
The Contractor shall forward the dates and times of any meeting with the FDA to BARDA
and make arrangements for appropriate BARDA staff to attend the FDA meetings if
requested by BARDA. BARDA may include up to a maximum of four people (COR, CO andup to 2 subject matter experts).
Contractor shall notify BARDA of upcoming FDA meetings within 24 hours of scheduling.
The Contractor shall forward initial Contractor and FDA-issued draft minutes and final
minutes of any meeting with the FDA to the CO and COR within 5 business days ofreceipt. All documents shall be duly
2. FDA Submissions & Correspondence
The Contractor shall provide BARDA the opportunity to review and comment upon all
documents submitted to the FDA. In addition, an electronic copy of the final FDA
submissions will also need to be submitted. All documents shall be duly marked asIf draft documents are submitted to the COR for review, the COR will provide feedback
to Contractor within 10 business days of receipt, or sooner as necessary to address FDA
deadlines or requests.
If BARDA reviews draft documents, the Contractor shall revise, as appropriate, theirsubmission.
Final FDA submissions and all email correspondence with the FDA related tosubmissions shall be submitted to the CO and COR no later than 5 calendar days of theirsubmission to, or email correspondence with, the FDA.
3. FDA Audits
In the event of an FDA inspection which occurs as a result of this contract and for the
product, or for any other FDA inspection that has the reasonable potential to impact theperformance of this contract, the Contractor shall provide the CO and COR with an exact
copy (non-redacted) of the FDA Form 483 and the Establishment Inspection Report (EIR)
within five (5) business days after the Contractors receipt of those documents. The
Contractor shall provide the COR and CO with copies of the plan for addressing areas ofnon-conformance to FDA regulations for GLP, GMP, or GCP guidelines as identified in
the audit report, status updates during the plans execution and a copy of all final
responses to the FDA. The Contractor shall also provide redacted copies of any FDA
audits received from subcontractors that occur as a result of this contract or for thisproduct. To the extent feasible, the Contractor shall make arrangements for BARDA
representative(s) to be present during the final debrief by the regulatory inspector.
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Contract Number:If draft documents are submitted to the COR for review, the COR will provide feedback
to Contractor within 10 business days of receipt, or sooner as necessary to address FDA
deadlines or requests.
If BARDA reviews draft documents, the Contractor shall revise as appropriate theirsubmission.
Contractor shall notify CO and COR within 10 business days of a scheduled FDA audit orwithin 24 hours of an ad hoc site visit/audit if the FDA does not provide 10 businessContractor shall provide copies of any FDA audit report received from subcontractorsthat occur as a result of this contract or for this product within 5 business days ofreceiving correspondence from the FDA, Subcontractor, or third party.
Within 15 business days of audit report, Contractor shall provide CO with a plan foraddressing areas of nonconformance, if any are identified.
Final FDA submissions shall be submitted to the CO and COR.
4. Other FDA Correspondence
The Contractor shall document any material correspondence between Contractor and
FDA as related to activities funded under this contract and submit to BARDA. All such
such written summary of any FDA correspondence or engagement within 5 businessdays and submit to the CO and COR. The written summary shall include:
A tracking log of progress on regulatory submissions with the FDA, description of thesubmission, date of the submission, status of submission and next steps.
B. REPORTING MATTERS OF FRAUD, WASTE, AND ABUSE
Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in
BARDA funded programs should report such matters to the DHHS Inspector General's Office inwriting or on the Inspector General's Hotline. The toll free number is 1-800-HHS-TIPS (1-800447-8477). All telephone calls will be handled confidentially. The e-mail address is
Htips@os.dhhs.gov and the mailing address is:
Office of Inspector General
Department of Health and Human Services TIPS HOTLINE
P.O. Box 23489 Washington, D.C. 20026
C. PROHBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST ACTIVITIESThe Contractor acknowledges that U.S. Executive Orders and Laws, including but not limited to13224 and P.L. 107-56, prohibit transactions with, and the provision of resources and support
to, individuals and organizations associated with terrorism. It is the legal responsibility of the

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Contract Number:Contractor to ensure compliance with these Executive Orders and Laws. This clause must be
included in all subcontracts issued under this Contract.
D. IDENTIFICATION AND DISPOSTION OF DATAThe Contractor will be required to provide certain data generated under this Contract to DHHS.
DHHS reserves the right to review any other data related to performance of this Contract.
The Contractor shall keep copies of all data required by the FDA relevant to this Contract for thetime specified by the FDA.
E. EXPORT CONTROL NOTIFICATION
Contractors are responsible for ensuring compliance with all export control laws and regulations
that may be applicable to the export of and foreign access to their proposed technologies.
Contractors may consult with the Department of State with any questions regarding theInternational Traffic in Arms Regulation (ITAR) (22 C.F.R. Parts 120-130) and /or the Departmentof Commerce regarding the Export Administration Regulations (15 C.F.R. Parts 730-774).
F. CONFLICT OF INTEREST
The Contractor represents and warrants that, to the best of the Contractor's knowledge andbelief, there are no relevant facts or circumstances which could give rise to an organizational
conflict of interest, as defined in FAR 2.101 and Subpart 9.5, or that the Contractor has disclosed
all such relevant information. Prior to commencement of any work, the Contractor agrees to
notify the CO promptly that, to the best of its knowledge and belief, no actual or potential
conflict of interest exists or to identify to the CO any actual or potential conflict of interest thefirm may have. In emergency situations, however, work may begin but notification shall bemade within five (5) working days. The Contractor agrees that if an actual or potential
organizational conflict of interest is identified during performance, the Contractor shall promptly
make a full disclosure in writing to the CO. This disclosure shall include a description of actions
which the Contractor has taken or proposes to take, after consultation with the CO, to avoid,
mitigate, or neutralize the actual or potential conflict of interest. The Contractor shall continue
performance until notified by the CO of any contrary action to be taken. Remedies include
termination of this Contract for convenience, in whole or in part, if the CO deems suchtermination necessary to avoid an organizational conflict of interest. If the Contractor wasaware of a potential organizational conflict of interest prior to award or discovered an actual or
potential conflict after award and did not disclose it or misrepresented relevant information to
the CO, 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 thisContract.
G. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATIONThe Contractor shall not use contract funds to disseminate information that is deliberately false
or misleading.

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Contract Number:
H. NEEDLE DISTRIBUTION
The Contractor shall not use contract funds to carry out any program of distributing sterile
needles or syringes for the hypodermic injection of any illegal drug.
I.

CONFIDENTIAILTIY OF INFORMATION
1. Confidential information, as used in this article, means information or data of a personal
nature about an individual, or proprietary information or data submitted by orpertaining to an institution or organization.
2. The CO and the Contractor may, by mutual consent, identify elsewhere in this Contract
specific information and/or categories of information which the Government will furnish
to the Contractor or that the Contractor is expected to generate which is confidential
and providing further that the Government is not entitled to unlimited rights to that
information pursuant to FAR 52.227-14. Similarly, the CO and the Contractor may, by
mutual consent, identify such confidential information from time to time during theperformance of the contract. Failure to agree will be settled pursuant to the "Disputes"
clause.
3. If it is established elsewhere in this Contract that information to be utilized under thisContract, or a portion thereof, is subject to the Privacy Act, the Contractor will follow
the rules and procedures of disclosure set forth in the Privacy Act of 1974, 5 U.S.C. 552a,
and implementing regulations and policies, with respect to systems of records
determined to be subject to the Privacy Act.
4. Confidential information, as defined in paragraph (a) of this article, shall not be
disclosed without the prior written consent of the individual, institution, or organization.
5. Whenever the Contractor is uncertain with regard to the proper handling of material
under the Contract, or if the material in question is subject to the Privacy Act or isconfidential information subject to the provisions of this article, the Contractor should
obtain a written determination from the CO prior to any release, disclosure,dissemination, or publication.
6. The provisions of paragraph (d) of this article shall not apply to conflicting or
overlapping provisions in other Federal, State or local laws.

J.

ACCESS TO DOCUMENTATION / DATAThe Government shall have physical and electronic access to all documentation and data
generated under this Contract, including: all data documenting Contractor performance; all data
generated; all communications and correspondence with regulatory agencies and bodies toinclude all audit observations, inspection reports, milestone completion documents, and all
Offeror commitments and responses. Contractor shall provide the Government with anelectronic copy of all correspondence and submissions to the FDA within 5 business days ofreceipt. The Government shall acquire unlimited rights to all data funded under this contract inaccordance with FAR Subpart 27.4 and FAR Clause 52.227-14.

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Contract Number:
K. ACKNOWLEDGEMENT OF FEDERAL FUDNING
Section 507 of P.L. 104-208 mandates that Contractors funded with Federal dollars, in whole orin part, acknowledge Federal funding when issuing statements, press releases, requests for
proposals, bid solicitations and other documents. This requirement is in addition to thecontinuing requirement to provide an acknowledgment of support and disclaimer on any
publication reporting the results of a contract funded activity.
Publication and Publicity
No information related to data obtained under this Contract shall be released or publicizedwithout providing BARDA with at least thirty (30) days advanced notice and an opportunity toreview the proposed release or publication.
In addition to the requirements set forth in this Contract, Section 507 of P.L. 104-208 mandates
that Contractors funded with Federal dollars, in whole or in part, acknowledge Federal funding
when issuing statements, press releases, requests for proposals, bid solicitations and otherdocuments. Contractors are required to state:
1. The percentage and dollar amounts of the total program or project costs financed with
Federal money and;2. The percentage and dollar amount of the total costs financed by non-governmental
sources. For purposes of this Contract "publication" is defined as an issue of printed
material offered for distribution or any communication or oral presentation of
information, including any manuscript or scientific meeting abstract. Any publication
containing data generated under this Contract must be submitted for BARDA review noless than thirty (30) calendar days for manuscripts and fifteen (15) calendar days for
abstracts before submission for public presentation or publication. Contract support
shall be acknowledged in all such publications substantially as follows:"This project has been funded in whole or in part with Federal funds from the
Department of Health and Human Services; Office of the Assistant Secretary for
Preparedness and Response; Biomedical Advanced Research and Development
Press Releases
Misrepresenting contract results or releasing information that is injurious to the integrity of
BARDA may be construed as improper conduct. Press releases shall be considered to include thepublic release of information to any medium, excluding peer-reviewed scientific publications.
With the exception of ad-hoc press releases required by applicable law or regulations, theContractor shall ensure that the COR has received an advance copy of any press release related
to the contract not less than two (2) business days prior to the issuance of the press release.
The Contractor shall acknowledge the support of the Department of Health and Human Service,
Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Researchand Development Authority, whenever publicizing the work under this contract in any media by
including an acknowledgment substantially as follows:
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Contract Number:"This project has been funded in whole or in part with Federal funds from the
Department of Health and Human Services; Office of the Assistant Secretary for
Preparedness and Response; Biomedical Advanced Research and Development
BARDA Use of Contractor Logo
as agreed to by the parties), for presentations, internal and external websites, and otherreasonable promotional and reporting uses relating to the project during the period of
performance of the Contract (or for a longer period, if agreed between the parties).
L. PRIVACY ACT APPLICABILITY
Notification is hereby given that the Contractor and its employees are subject to criminal
penalties for violation of the Privacy Act to the same extent as employees of the Government.
The Contractor shall assure that each of its employees knows the prescribed rules of conduct
and that each is aware that he or she can be subjected to criminal penalty for violation of theAct. A copy of 45 C.F.R. Part 5b, Privacy Act Regulations, may be obtained athttps://www.gpo.gov/fdsys/granule/CFR-2007- title45-vol1/CFR-2007-title45-vol1-part5b.
The Contractor is responsible for monitoring contractor compliance with the Privacy Act.
The Contractor shall follow the Privacy Act guidance as contained in the Privacy Act System ofRecords number 09-25-0200.
M. LABORATORY LICENSE REQUIREMENTS
The Contractor shall comply with all applicable requirements of Section 353 of the Public HealthService Act (Clinical Laboratory Improvement Act as amended) (42 U.S.C. 263a) and 42 CFR Part
493. This requirement shall also be included in any subcontract for services under the Contract.
N. QUALITY ASSURANCE (QA) AUDIT REPORTS
BARDA reserves the right to participate in QA audits as related to activities funded under thisContract. Upon completion of the audit/site visit the Contractor shall provide a report capturing
the findings, results and next steps in proceeding with the subcontractor. If action is requestedof the subcontractor, detailed concerns for addressing areas of non-conformance to FDA
regulations for GLP, GMP, or GCP guidelines, as identified in the audit report, must be provided
to BARDA. The Contractor shall provide responses from the subcontractors to address theseconcerns and plans for corrective action execution.
1. Contractor shall notify CO and COR of upcoming, ongoing, or recent audits/site visits of
subcontractors as part of weekly communications.
2. Contractor shall notify the COR and CO within five (5) business days of reportcompletion.

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Contract Number:O. BARDA AUDITS
Contractor shall accommodate periodic or reasonable ad hoc site visits during normal businesshours by the Government with forty-eight (48) hours advance notice. If the Government, theContractor, or other parties identifies any issues during an audit, the Contractor shall capture
the issues, identify potential solutions, and provide a report to the Government.
1. If issues are identified during the audit, Contractor shall submit a report to the CO andCOR detailing the finding and corrective action(s) within 10 business days of the audit.
2. COR and CO will review the report and provide a response to the Contractor with ten(10) business days.
3. Once corrective action is completed, the Contractor will provide a final report to the CO
and COR.
P. RESTRICTION ON EMPLOYMENT OF UNAUTHORIZED ALIEN WORKERS
The Contractor shall not use Contract funds to employ workers described in Section 274A
(h)(3) of the Immigration and National Act, which reads as follows:with respect to the employment of an alien at a particular time, that the alien is not at thattime either an alien lawfully admitted for permanent residence, or (B) authorized to be so
Q. NOTIFICATION OF CRITICAL PROGRAMMATIC CONCERNS, RISK, OR POTENTIAL RISKS
If any action occurs that creates a cause for critical programmatic concern, risk, or potential risk
to BARDA or the Contractor an Incident Report shall be delivered to BARDA.
1. Within 48 hours of activity or incident or within 24 hours for a security related activity or
incident, Contractor must notify BARDA.
2. Additional updates due to COR and CO within 48 hours of additional developments.
3. Contractor shall submit within 5 business days a Corrective Action Plan (if deemednecessary by either party) to address any potential issues.
If corrective action is deemed necessary, Contractor must address in writing its consideration ofconcerns raised by BARDA within 5 business days of receiving comments by BARDA.
R. DISSEMINATION OF INFORMATIONOther than scientific and technical data for which the Contractor can assert a copyright under
FAR Clause 52.227-14 (c), no information related to data obtained under this Contract shall be
released or publicized without the prior written consent of the CO. In the event that theContractor seeks to publicize scientific and technical data, the contractor shall provide BARDA,
through the COR, with a minimum of thirty (30) business days to review the particular scientificand technical data prior to publication.

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S. REGISTRATION WITH THE SELECT AGENT PROGRAM FOR WORK INVOLVING THE POSSESSION,
USE, AND / OR TRANSFER OF SELECT BIOLOGICAL AGENTS OR TOXINSWork involving select biological agents or toxins shall not be conducted under this Contract until
the Contractor and any affected subcontractor(s) are granted a certificate of registration or are
authorized to work with the applicable select agents.
For prime or subcontract awards to domestic institutions who possess, use, and/or transfer
Select Agents under this contract, the institution must complete registration with the Centers
for Disease Control and Prevention (CDC), DHHS or the Animal and Plant Health Inspection
Services (APHIS), U.S. Department of Agriculture (USDA), as applicable, before performing work
involving Select Agents, in accordance with 42 C.F.R. Part 73. No Government funds can be used
for work involving Select Agents, as defined in 42 C.F.R. Part 73, if the final registration
certificate is denied.
For prime or subcontract awards to foreign institutions who possess, use, and/or transfer SelectAgents under this Contract, the institution must provide information satisfactory to theGovernment that a process equivalent to that described in 42 C.F.R. Part 73(http://www.cdc.gov/od/sap/docs/42cfr73.pdf ) for U.S. institutions is in place and will beadministered on behalf of all Select Agent work sponsored by these funds before using thesefunds for any work directly involving the Select Agents. The Contractor must provide
information addressing the following key elements appropriate for the foreign institution:
safety, security, training, procedures for ensuring that only approved/appropriate individuals
have access to the Select Agents, and any applicable laws, regulations and policies equivalent to
42 C.F.R. Part 73. The Government will assess the policies and procedures for comparability to
the U.S. requirements described in 42 C.F.R. Part 73. When requested by the CO, the Contractor
shall provide key information delineating any laws, regulations, policies, and procedures
applicable to the foreign institution for the safe and secure possession, use, and transfer ofSelect Agents. This includes summaries of safety, security, and training plans, and applicablelaws, regulations, and policies. For the purpose of security risk assessments, the Contractor must
provide the names of all individuals at the foreign institution who will have access to the SelectAgents and procedures for ensuring that only approved and appropriate individuals have accessto Select Agents under the Contract.
Listings of HHS select agents and toxins, biologic agents and toxins, and overlap agents or toxins
as well as information about the registration process, can be obtained on the Select Agent
Program Web site at https://www.selectagents.gov/
T. MANUFACTURING STANDARDSThe Good Manufacturing Practice Regulations (GMP) (21 C.F.R. Part 820) will be the standard tobe applied for manufacturing, processing, packaging, storage and delivery of this product.
If at any time during the life of the Contract, the Contractor fails to comply with GMP in the
manufacturing, processing, packaging, storage, stability and other testing of the manufactured
drug substance or product and delivery of this product and such failure results in a material
adverse effect on the safety, purity or potency of the product (a material failure) as identified byPage 8 of 19

Contract Number:
the FDA, the Contractor shall have thirty (30) calendar days from the time such material failure
is identified to cure such material failure. If, within the thirty (30) calendar day period, theContractor fails to take such an action to the satisfaction of the Government Project
Officer/COR, or fails to provide a remediation plan that is acceptable to the COR, then theContract may be terminated.
U. SHARING RESEARCH DATAThe Contractor's data sharing plan, due date to be determined at contract award, is hereby
incorporated by reference. The Contractor agrees to adhere to its plan and shall request priorapproval of the CO for any changes in its plan.
BARDA endorses the sharing of final research data to serve health. This contract is expected togenerate research data that must be shared with the public and other researchers.
BARDA recognizes that data sharing may be complicated or limited, in some cases, byinstitutional policies, local IRB rules, as well as local, state and Federal laws and regulations,
including the Privacy Rule (see HHS-published documentation on the Health Information Privacy
at http://www.hhs.gov/ocr/privacy/index.html). The rights and privacy of people who
participate in BARDA-funded research must be protected at all times; thus, data intended forbroader use should be free of identifiers that would permit linkages to individual research
participants and variables that could lead to deductive disclosure of the identity of individual
subjects.
V. PUBLIC ACCESS TO ARCHIVED PUBLICATIONS RESULTING FROM ASPER FUNDED RESEARCHAll ASPR-funded investigators shall submit to the National Institutes of Health (NIH) National
Library of Medicine's (NLM) PubMed Central (PMC) an electronic version of the author's final
manuscript, upon acceptance for publication, of any peer-reviewed scientific publications
resulting from research supported in whole or in part with Federal funds from the Department
of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response.
ASPR defines the author's final manuscript as the final version accepted for journal publication,and includes all modifications from the publishing peer review process. The PMC archive will
preserve permanently these manuscripts for use by the public, health care providers, educators,
scientists, and ASPR. The Policy directs electronic submissions to the NIH/NLM/PMC:
http://www.pubmedcentral.nih.gov.
W. INSITUTIONAL RESPONSBILITY REGARDING CONFLICTING INTERESTS OF INVESTIGATORSThe Contractor shall comply with the requirements of 45 C.F.R. Part 94, Responsible Prospective
Contractors, which promotes objectivity in research by establishing standards to ensure thatinvestigators (defined as the principal investigator and any other person who is responsible forthe design, conduct, or reporting of research funded under BARDA contracts) will not be biased
by any conflicting financial interest.
As required by 45 C.F.R. Part 94, the Contractor shall, at a minimum:

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Contract Number:
1. Maintain a written, enforceable policy on conflict of interest that complies with 45
C.F.R. Part 94 and inform each investigator of the policy, the investigator's reporting
responsibilities, and the applicable regulations. The Contractor must take reasonable
steps to ensure that investigators working as collaborators or subcontractors comply
with the regulations.
2. Designate an official(s) to solicit and review financial disclosure statements from each
investigator participating in BARDA-funded research. Based on established guidelines
consistent with the regulations, the designated official(s) must determine whether aconflict of interest exists, and if so, determine what actions should be taken to manage,
reduce, or eliminate such conflict. A conflict of interest exists when the designatedofficial(s) reasonably determines that a Significant Financial Interest could directly andsignificantly affect the design, conduct, or reporting of the BARDA-funded research. The
Contractor may require the management of other conflicting financial interests inaddition to those described in this paragraph, as it deems appropriate. Examples ofconditions or restrictions that might be imposed to manage actual or potential conflictsof interests are included in 45 C.F.R. Part 94, under Management of Conflicting
Interests.
3. Require all financial disclosures to be updated during the period of the award, either onan annual basis or as new reportable Significant Financial Interests are obtained.
4. Maintain records, identifiable to each award, of all financial disclosures and all actions
taken by the Contractor with respect to each conflicting interest 3 years after final
payment or, where applicable, for the other time periods specified in 48 C.F.R. Part 4,
subpart 4.7, Contract Records Retention.
5. Establish adequate enforcement mechanisms and provide for sanctions whereappropriate.
If a conflict of interest is identified, the Contractor shall report to the CO, the existence of theconflicting interest found. This report shall be made and the conflicting interest managed,
reduced, or eliminated, at least on a temporary basis, within sixty (60) days of that
identification.
If the failure of an investigator to comply with the conflict of interest policy has biased thedesign, conduct, or reporting of the BARDA-funded research, the Contractor must promptly
notify the CO of the corrective action taken or to be taken. The CO will take appropriate action
or refer the matter to the Contractor for further action, which may include directions to theContractor on how to maintain appropriate objectivity in the funded research.
The CO may at any time inquire into the Contractor's procedures and actions regarding conflictsof interests in BARDA-funded research, including a review of all records pertinent to compliancewith 45 C.F.R. Part 94. The CO may require submission of the records or review them on site. On
the basis of this review, the CO may decide that a particular conflict of interest will bias theobjectivity of the BARDA-funded research to such an extent that further corrective action isPage 10 of 19

Contract Number:needed or that the Contractor has not managed, reduced, or eliminated the conflict of interest.
The issuance of a Stop Work Order by the CO may be necessary until the matter is resolved.
If the CO determines that BARDA-funded clinical research, whose purpose is to evaluate thesafety or effectiveness of a drug, medical device, or treatment, has been designed, conducted,
or reported by an investigator with a conflict of interest that was not disclosed or managed, theContractor must require disclosure of the conflict of interest in each public presentation of theresults of the research.
X. CLINICAL TERMS OF AWARD
In addition to those terms and conditions outlined under applicable HHSAR clauses incorporated
by reference by Section I of this Contract, the following clinical terms of award detail anagreement between the BARDA and the Contractor; they apply to all contracts involving clinicalresearch.
Draft protocols for each clinical study will be submitted to BARDA for evaluation and comment.
BARDA comments will be addressed and/or incorporated into the draft protocol prior to
submission to the FDA for comment, if required and as appropriate.
BARDA shall have unlimited rights to all protocols, data generated from the execution of these
protocols, and final reports, funded by BARDA under this Contract, as defined in Rights in Data
Clause in FAR 52.227-14. BARDA reserves the right to request that the Contractor provide any
contract deliverable in a non-proprietary form without any restrictive legends to ensure BARDA
has the ability to review and distribute the deliverables, as BARDA deems necessary.
Important information regarding performing human subject research is available here andshould be addressed by the contractor. https://www.hhs.gov/ohrp/

Any updates to clinical studies (enrollment, technical results, etc.) are to be addressed in theMonthly and Annual Progress Reports, as well as technical monthly calls. The Contractor shalladvise the COR or designee in writing and via electronic communication in a timely manner of
any issues potentially affecting contract performance.
1. Safety and Monitoring Issues
i. Institutional Review Board or Independent Ethics Committee Approval
Before award and then with the annual progress report, the Contractor must
submit to BARDA a copy of the current IRB-or IEC-approved informed consent
document, documentation of continuing review and approval and the OHRP
federal wide assurance number for the institution or site.
If other institutions are involved in the research (e.g., a multicenter clinical trial
They must also provide BARDA initial and annual documentation of continuing
review and approval, including the current approved informed consent
document and federal wide number.
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The Contractor must ensure that the application as well as all protocols arereviewed by their IRB or IEC.
To help ensure the safety of participants enrolled in BARDA-funded studies, theContractor must provide BARDA copies of documents related to all majorchanges in the status of ongoing protocols, including the following:a. All amendments or changes to the protocol, identified by protocol
version number, date, or both and dates it is valid.
b. All changes in informed consent documents, identified by version
number, dates, or both and dates it is valid.
c. Termination or temporary suspension of patient accrual.
d. Termination or temporary suspension of the protocol.
e. Any change in IRB approval.
f.

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

The Contractor must notify BARDA through the COR or CO of any of the abovechanges within five (5) working days by email or fax, followed by a letter signedby the institutional business official, detailing notification of the change ofstatus to the local IRB and a copy of any responses from the IRB or IEC.
If a clinical protocol has been reviewed by an institutional biosafety committee(IBC) or the NIH Recombinant DNA Advisory Committee (RAC), the Contractor
must provide information about the initial and ongoing review and approval, if
any. See the NIH Guidelines for Research Involving Recombinant DNA
Molecules.
ii. Data and Safety Monitoring Requirements
BARDA strongly recommends independent safety monitoring for clinical trials ofinvestigational drugs, devices, or biologics; clinical trial of licensed products; andclinical research of any type involving more than minimal risk to volunteers.
Independent monitoring can take a variety of forms. Phase III clinical trials must
be reviewed by an independent data and safety monitoring board (DSMB);
other trials may require DSMB oversight as well. The Contractor shall inform
BARDA of any upcoming site visits and/or audits of CRO facilities funded under
this effort. BARDA reserves the right to accompany the Contractor on site visits
and/or audits of CROs as BARDA deems necessary. The Contractor shall inform
BARDA 30 days in advance of a DSMB board meetings for studies funded under
this effort. BARDA reserves the right to participate in the DSMB board meetingson an impromptu basis as a non-voting member, if feasible per the structure of
the study. If not, the communications from the DSMB to the Contractor should
be made available to BARDA upon receipt.
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Contract Number:
A risk is minimal where the probability and magnitude of harm or discomfort
anticipated in the proposed research are not greater than those ordinarily
encountered in daily life or during the performance of routine physical or
psychological examinations or tests. For examples, the risk of drawing a small
amount of blood from a healthy individual for research purposes is no greaterthan the risk of doing so as part of a routine physical examination (45 C.F.R. §46.102(j)).
Final decisions regarding the type of monitoring to be used must be made by
the Contractor, based on FDA and BARDA guidance, before enrollment starts.
Discussions with the responsible BARDA PO/COR regarding appropriate safety
monitoring must take place, and the Contractor must submit a written response
to all concerns raised by BARDA, before patient enrollment begins and may
include discussions about the appointment of one of the following:a physician or other appropriate expert who is
independent of the study and available in real time to review and recommend
appropriate action regarding adverse events and other safety issues.
Independent Monitoring Committee (IMC) or Safety Monitoring Committee
a small group of independent investigators and biostatisticians who
review data from a particular study.
an independent committee charged withreviewing safety and trial progress and providing advice with respect to study
continuation, modification, and termination. The Contractor may use anestablished BARDA DSMB or to organize an independent DSMB. All phase III
clinical trials must be reviewed by a DSMB; other trials may require DSMB
oversight as well. Please refer to: NIAID Principles for Use of a Data and Safety
Monitoring Board (DSMB) For Oversight of Clinical Trials Policy. BARDA should
be provided documentation from DSMB and should be provided with any
decisions by Contractor regarding the DMSB as it relates to work under thiscontract.
When a monitor or monitoring board is organized, a description of it, its charteror operating procedures (including a proposed meeting schedule and plan forreview of adverse events), and roster and curriculum vitae from all members
must be submitted to BARDA before enrollment starts. If concerns are raised,
Contractor must address all concerns to BARDA, in writing, before enrollment
begins. The Contractor will also ensure that the monitors and board members
report any conflicts of interest and the Contractor will maintain a record of this.
The Contractor will share conflict of interest reports with BARDA.
Additionally, the Contractor must submit written summaries of all reviews
conducted by the monitoring group to the BARDA within thirty (30) days ofreviews or meetings.

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2. BARDA Protocol Review Process Before Patient Enrollment Begins
BARDA has a responsibility to ensure that mechanisms and procedures are in place toprotect the safety of participants in BARDA-supported clinical trials. Therefore, before
patient accrual or participant enrollment, the Contractor must ensure the following (asapplicable) are in place at each participating institution, prior to patient accrual orenrollment:i. IRB- or IEC-approved clinical research protocol identified by version number,date, or both, including details of study design, proposed interventions, patienteligibility, and exclusion criteria.
ii. Documentation of IRB or IEC approval, including OHRP federal wide number, IRB
or IEC registration number, and IRB and IEC name.
iii. IRB- or IEC- approved informed consent form/document, identified by version
number, date, or both and dates it is valid.
iv. Plans for the management of side effects.
v. Procedures for assessing and reporting adverse events.
vi. Plans for data and safety monitoring (see above) and monitoring of the clinicalstudy site, pharmacy, and laboratory.
vii. Documentation that the Contractor and all study staff responsible for the design
or conduct of the research have received training in the protection of humansubjects.
Documentation to demonstrate that each of the above items are in place shall be
submitted to BARDA) for evaluation and comment in conjunction with the protocol.
Execution of clinical studies requires written authorization from BARDA in accordancewith this section of this contract.
3. Investigational New Drug or Investigational Device Exemption Requirements
Consistent with federal regulations, applicable clinical research projects involving theuse of investigational therapeutics, vaccines, or other medical interventions (including
licensed products and devices for a purpose other than that for which they werelicensed) in humans under a research protocol must be performed under a FDA
investigational new drug (IND) or investigational device exemption (IDE).
Where an IND and IDE is otherwise required, exceptions must be granted in writing by
FDA. If the proposed clinical trial will be performed under an IND or IDE, the Contractor
must provide BARDA with the name and institution of the IND or IDE sponsor, the datethe IND or IDE was filed with FDA, the FDA IND or IDE number, any written commentsfrom FDA, and the written responses to those comments.

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In instances in which an IND or IDE is required, unless FDA notifies Contractor otherwise,
the Contractor must wait thirty (30) calendar days from FDA receipt of an initial IND or
IDE application before initiating a clinical trial.
The Contractor must notify BARDA if the FDA places the study on clinical hold andprovide BARDA any written comments from FDA, written responses to the comments,
and documentation in writing that the hold has been lifted.
The Contractor must not use grant or contract funds during a clinical hold to fundclinical studies that are on hold other than costs that are associated with activities
related to patients coming off study, monitoring, or ending the study. The Contractor
must not enter into any new financial obligations related to clinical activities for theclinical trial on clinical hold.
4. Required Time-Sensitive Notificationi. Under an IND or IDE, the sponsor must provide FDA safety reports of serious
adverse events. Under these Clinical Terms of Award, the Contractor must
submit copies to the responsible BARDA representative or the COR as follows:a. Expedited safety report of unexpected or life-threatening experience ordeath. A copy of any report of unexpected or life-threatening
experience or death associated with the use of an IND drug, which must
be reported to FDA by telephone or fax as soon as possible but no latermust be submitted to BARDA representative or COR within 24 hours of
FDA notification.
b. Expedited safety reports of serious and unexpected adverse
experiences. A copy of any report of unexpected and serious adverse
experience associated with use of an IND drug or any finding from tests
in laboratory animals that suggests a significant risk for human subjects,
which must be reported in writing to FDA as soon as possible but nomust be submitted to the BARDA representative or COR within 24 hoursof FDA notification.
c. IDE reports of unanticipated adverse device effect. A copy of any
reports of unanticipated adverse device effect submitted to FDA mustbe submitted to BARDA representative or COR within 24 hours of FDA
notification.
d. Expedited safety reports. Sent to BARDA representative or the COR
concurrently with the report to FDA.
e. Other adverse events documented during the course of the trial should
be included in the annual IND or IDE report and reported to BARDA
annually.
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Contract Number:ii. Safety reporting for research not performed under an IND or IDE:
Final decisions regarding ongoing safety reporting requirements for research
not performed under an IND or IDE must be made jointly by the BARDA PO or
the COR and the Contractor.
In case of problems or issues the COR will contact the Contractor within ten (10)working days by email or fax, followed within thirty (30) calendar days by an official
sponsored programs, listing issues and appropriate actions to be discussed.
5. Human Material (Assurance of OHRP Compliance).
The acquisition and supply of all human specimen material (including fetal material)used under this Contract shall be obtained by Contractor in full compliance withapplicable Federal, State and Local laws and the provisions of the Uniform Anatomical
Gift Act in the United States, and no undue inducements, monetary or otherwise, will beoffered to any person to influence their donation of human material.
The Contractor shall provide written documentation that all human materials obtained
as a result of research involving human subjects conducted under this Contract, bycollaborating sites, or by subcontractors identified under this Contract, were obtainedwith prior approval by the Office for Human Research Protections (OHRP) of an
Assurance to comply with the requirements of 45 C.F.R. 46 to protect human researchsubjects. This restriction applies to all collaborating sites without OHRP-approved
Assurances, whether domestic or foreign, and compliance must be ensured byContractor.
Provision by the Contractor to the CO of a properly completed "Protection of Human
Subjects Assurance Identification/IRB Certification/Declaration of Exemption", FormOMB No. 0990-0263(formerly Optional Form 310), certifying IRB review and approval of
the protocol from which the human materials were obtained constitutes the written
documentation required. The human subject certification can be met by submission of aself-designated form provided that it contains the information required by the"Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of
Exemption", Form OMB No. 0990-0263 (formerly Optional Form 310).
Y. FOREIGN TRANSFER OF ASSETS OR TECHNOLOGYThis clause shall remain in effect during the term of the Contract and for five (5) years
thereafter.
1. Definitions
AFFILIATES: Associated business concerns, non-profit organizations, or individuals if,
directly or indirectly, (1) either one controls or can control the other; or (2) a third party
controls or can control both.

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ASSET(S): Tangible or intangible manifestations of technologies having economic value
and capable of being conveyed between economic or Governmental entities that is thefocus/scope of development by the U.S. Go
Contract.
ASSET(S): Tangible or intangible manifestations of technologies having economic value
and capable of being conveyed between economic or Governmental entities that is theContract.
FOREIGN FIRM OR INSTITUTION: A firm or institution organized or existing under thelaws of a country other than the United States of America (U.S.), its territories, orpossessions. The term includes, for purposes of this Contract, any agency or
instrumentality of a foreign government; and firms, institutions or businessorganizations which are owned or substantially controlled by foreign governments,
firms, institutions, or individuals.
TECHNOLOGY: Technical Data, Computer Software, manufactured materials andSubject Inventions funded by the USG under this Contract. Technology also includes
contractor know how and personnel expertise, as well as other Assets necessary toassure successful completion of this Contract.
U.S. FIRM OR INSTITUTION: A firm or institution organized or existing under the laws of
the United States, its territories, or possessions. The term includes, for purposes of thisContract, any agency or instrumentality of the USG; and firms, institutions or businessorganizations which are owned or substantially controlled by U.S. citizens, firms,
institutions, governmental agencies or individuals.
2. General
The parties agree that research findings and technological developments made under
this Contract constitute an investment by the USG on behalf of its citizens in the interestof their economic and national health security. These investments are made for the
primary benefit of the citizenry of the United States with those same benefits
potentially accruing to the people of all nations. Therefore, the USG has a fiduciary
responsibility to protect the full invested value of the Assets and Technology developed
under this Contract. The USG is also cognizant of the duty the Contractor has to its
shareholders and other stakeholders with a vested interested in the economic successof the Contractor. At times both parties are aware their respective interests may
diverge. Therefore, in the course of conducting business though the Contract, access totechnology developments under this Contract by Foreign Firms or Institutions must be
carefully considered.
3. Export Controls
Contractor agrees to comply with all applicable laws regarding export controls and not
to export any Asset or Technology to any U.S. embargoed countries.

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4. Post-award Transfer of Ownership of Assets or Technology
The Contractor shall provide notice to the CO and COR within three (3) business days ofany discussions of a proposed transfer of ownership or establishment of a licensing
agreement of any Asset or Technology funded under this Contract from the Contractor
to a Foreign Firm or Institution. Notice will also be given within three (3) business daysof any discussions of a proposed transfer of operational, corporate, or economic controlof Assets and Technology funded under this Contract to Foreign Firms or Institutions.
This Article shall not apply to transfers by the Contractor to Affiliated entities of theContractor, as well as technology transfers for the purposes of manufacturing inaccordance with the Statement of Work.
Prior to transferring any Asset funded by the USG under this Contract, the Contractor
should carefully review the USG rights under FAR Subpart 42.12 pertaining to Novation,
specifically FAR section 42.1204. That provision provides that the USG may recognize athird party assignment only if the transfer of Assets and Technology is determined to be
obligation to recognize a successor in interest. If the CO determines that a transfer ofAssets and Technology may have adverse consequences to the economic well-being or
national health security interests of the U.S., the Contractor, and the CO shall jointly
endeavor to find alternatives to the proposed transfer which obviate or mitigate
potential adverse consequences of the transfer but which may provide substantiallyequivalent benefits to the Contractor.
In addition to the USG licensing rights to subject inventions and technical data funded
under this Contract, see FAR clause 52.227-11 (Patent Rights-Ownership by theContractor) and FAR Clause 52.227-14 (Rights in Data - General), the USG shall have afirst right of refusal for the purchase of the Asset and/or Technology funded under theContract. The USG may waive this first right of refusal in writing submitted to theContractor within ninety (90) calendar days of the initial notification to the USG of the
Except for transfers to affiliates of the Contractor, including those entities necessary tocomplete the Statement of Work, the Contractor shall provide written notice to the CO
and COR of the scheduled transfer to a Foreign Firm or Institution at least ninety (90)calendar days prior to the scheduled date of transfer. Such notice shall cite this Article
and shall specifically identify the Asset or Technology proposed for the transfer and thegeneral terms of the transfer. No transfer shall take place without written concurrence
from the CO.
5. Transfer to a Prohibited Source
In the event of a transfer of an Asset and/or Technology by the Contractor to a Foreign
Firm or Institution which is identified as a Prohibited Source pursuant to FAR Subpart
25.7: (a) the USG may terminate this Contract for cause and (b) the license rights to thetechnical data and subject invention under the relevant FAR IP Clauses (FAR Clause

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52.227-11 and FAR Clause 52-227-14) shall survive the termination. Upon request of the
USG, the Contractor shall provide written confirmation of such licenses.
6. Lower Tier Agreements
The Contractor shall include this Article, suitably modified, to identify the Parties, in all
subcontracts or lower tier agreements, regardless of tier.

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A(2) When any supply or service acquired under this contract is subject to a commercial supplier
agreement, and notwithstanding any other provision of this agreement, when the end user is anagency or instrumentality of the U.S. Government, the following language shall be deemedincorporated into the commercial supplier agreem
the commercial supplier agreement.
(i) Applicability. This agreement is a part of a contract between the commercial supplier andthe U.S. Government for the acquisition of the supply or service that necessitates a license orother similar legal instrument (including all contracts, task orders, and delivery orders under
FAR Part 12).
(ii) End user. This agreement shall bind the ordering activity as end user but shall not operate
to bind a Government employee or person acting on behalf of the Government in his or her
personal capacity.
(iii) Law and disputes. This agreement is governed by Federal law.
(A) Any language purporting to subject the U.S. Government to the laws of a U.S. state,
U.S. territory, district, or municipality, or a foreign nation, except where Federal law
expressly provides for the application of such laws, is hereby deleted.
(B) Any language requiring dispute resolution in a specific forum or venue that isdifferent from that prescribed by applicable Federal law is hereby deleted.
(C) Any language prescribing a different time period for bringing an action than thatprescribed by applicable Federal law in relation to a dispute is hereby deleted.
(iv) Continued performance. The supplier or licensor shall not unilaterally revoke, terminate
or suspend any rights granted to the Government except as allowed by this contract. If the
supplier or licensor believes the ordering activity to be in breach of the agreement, it shallpursue its rights under the Contract Disputes Act or other applicable Federal statute while
continuing performance as set forth in subparagraph 52.212-4(d) (Disputes).
(v) Arbitration; equitable or injunctive relief. In the event of a claim or dispute arising underor relating to this agreement, a binding arbitration shall not be used unless specificallyauthorized by agency guidance, and equitable or injunctive relief, including the award of
attorney fees, costs or interest, may be awarded against the U.S. Government only when
explicitly provided by statute (e.g., Prompt Payment Act or Equal Access to Justice Act).

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Contract Number:A(vi) Updating terms.
(A) After award, the contractor may unilaterally revise commercial supplier agreement
terms if they are not material. A material change is defined as:(1) Terms that change Government rights or obligations;(2) Terms that increase Government prices;(3) Terms that decrease overall level of service; or(4) Terms that limit any other Government right addressed elsewhere in this contract.
(B) For revisions that will materially change the terms of the contract, the revisedcommercial supplier agreement must be incorporated into the contract using a bilateralmodification.
(C) Any agreement terms or conditions unilaterally revised subsequent to award that areinconsistent with any material term or provision of this contract shall not be enforceable
against the Government, and the Government shall not be deemed to have consented tothem.
(vii) No automatic renewals. If any license or service tied to periodic payment is provided
under this agreement (e.g., annual software maintenance or annual lease term), such license
or service shall not renew automatically upon expiration of its current term without prior
express consent by an authorized Government representative.
(viii) Indemnification. Any clause of this agreement requiring the commercial supplier or
licensor to defend or indemnify the end user is hereby amended to provide that the U.S.
Department of Justice has the sole right to represent the United States in any such action, in
accordance with 28 U.S.C. 516.
(ix) Audits. Any clause of this agreement permitting the commercial supplier or licensor to(A) Discrepancies found in an audit may result in a charge by the commercial supplier or
licensor to the ordering activity. Any resulting invoice must comply with the proper
invoicing requirements specified in the underlying Government contract or order.

Page 3 of 4

Contract Number:

A(B) This charge, if disputed by the ordering activity, will be resolved in accordance with
subparagraph (d) (Disputes); no payment obligation shall arise on the part of the ordering
activity until the conclusion of the dispute process.
(C) Any audit requested by the contractor will be performed at the contractor's expense,
without reimbursement by the Government.
(x) Taxes or surcharges. Any taxes or surcharges which the commercial supplier or licensor
seeks to pass along to the Government as end user will be governed by the terms of theunderlying Government contract or order and, in any event, must be submitted to theContracting Officer for a determination of applicability prior to invoicing unless specificallyagreed to otherwise in the Government contract.
(xi) Non-assignment. This agreement may not be assigned, nor may any rights or obligations
thereunder be delegated, without the Government's prior approval, except as expressly
permitted under subparagraph (b) of this clause.
(xii) Confidential information. If this agreement includes a confidentiality clause, such clauseis hereby amended to state that neither the agreement nor the contract price list, as applicable,
resolved consistent with the Freedom of Information Act. Notwithstanding anything in thisagreement to the contrary, the Government may retain any confidential information as
required by law, regulation or its internal document retention procedures for legal, regulatory
or compliance purposes; provided, however, that all such retained confidential information
will continue to be subject to the confidentiality obligations of this agreement.
(3) If any language, provision, or clause of this agreement conflicts or is inconsistent with thepreceding paragraph (1), the language, provisions, or clause of paragraph (1) shall prevail to theextent of such inconsistency.
(End of clause)

Page 4 of 4Contract Number:

Attachment 6 - FAR 52.212-5(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting
Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders
applicable to acquisitions of commercial items:[Contracting Officer check as appropriate.](1)52.222-17

Nondisplacement of Qualified Workers (May 2014)(E.O. 13495).

(2)

52.222-41

Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter 67).

(3)

52.222-42

Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter
67). Requires CO completion.

(4)52.222-43

Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple Yearand Option Contracts) (Aug 2018) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

(5)52.222-44(29 U.S.C. 206 and 41 U.S.C. chapter 67).

(6)

52.222-51

Exemption from Application of the Service Contract Labor Standards to Contracts forchapter 67).

(7)52.222-53

Exemption from Application of the Service Contract Labor Standards to Contracts for Certain(8)

52.222-55

Minimum Wages Under Executive Order 13658 (Dec 2015).

(9)52.222-62

Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).

(10) 52.226-6

Promoting Excess Food Donation to Nonprofit Organizations (May 2014) (42 U.S.C. 1792).

(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if thiscontract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for
examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in
FAR subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partiallyterminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination
settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or
relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.
(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardlessof type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not
maintain in the ordinary course of business or pursuant to a provision of law.

Contract Number:

Attachment 6 - FAR 52.212-5(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not
required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unlessotherwise indicated below, the extent of the flow down shall be as required by the clause(i) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509).
(ii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of
Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its
successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).
(iii) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab
and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).
(iv) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.
(Aug 2019) (Section 889(a)(1)(A) of Pub. L. 115-232).
(v) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C.637(d)(2) and (3)), in all subcontracts that offer
further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $700,000($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts thatoffer subcontracting opportunities.
(vi) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495). Flow down required in accordance withparagraph (l) of FAR clause 52.222-17.
(vii) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).
(viii) 52.222-26, Equal Opportunity (Sept 2015) (E.O.11246).
(ix) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C.4212).
(x) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C.793).
(xi) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C.4212)(xii) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). Flow
down required in accordance with paragraph (f) of FAR clause 52.222-40.
(xiii) 52.222-41, Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter 67).
(xiv) (A) 52.222-50, Combating Trafficking in Persons (Jan 2019) (22 U.S.C. chapter 78 and E.O 13627).
(B) Alternate I (Mar 2015) of 52.222-50(22 U.S.C. chapter 78 and E.O 13627).
(xv) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance,
Calibration, or Repair of Certain Equipment-Requirements (May 2014) (41 U.S.C. chapter 67).
(xvi) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain
Services-Requirements (May 2014) (41 U.S.C. chapter 67).
(xvii) 52.222-54, Employment Eligibility Verification (Oct 2015) (E.O. 12989).
(xviii) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).
(xix) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2017) (E.O. 13706).
(xx) (A) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).
(B) Alternate I (Jan 2017) of 52.224-3.
(xxi) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as
amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).
(xxii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (May 2014) (42 U.S.C. 1792). Flow down
required in accordance with paragraph (e) of FAR clause 52.226-6.
(xxiii) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx.1241(b) and 10
U.S.C.2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.
(2) While not required, the Contractor may include in its subcontracts for commercial items a minimal number of additionalclauses necessary to satisfy its contractual obligations.
(End of clause)
Alternate I (Feb 2000). As prescribed in 12.301(b)(4)(i), delete paragraph (d) from the basic clause, redesignate paragraph (e) asContract Number:

Attachment 6 - FAR 52.212-5

Alternate II (Aug 2019). As prescribed in 12.301(b)(4)(ii), substitute the following paragraphs (d)(1) and (e)(1) for
paragraphs (d)(1) and (e)(1) of the basic clause as follows:(d)(1) The Comptroller General of the United States, an appropriate Inspector General appointed under section 3 or 8 G of theInspector General Act of 1978 (5 U.S.C. App.), or an authorized representative of either of the foregoing officials shall havecontract; and(ii) Interview any officer or employee regarding such transactions.
(e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), and (c), of this clause, the Contractor is not
required to flow down any FAR clause in a subcontract for commercial items, other than(i) Paragraph (d) of this clause. This paragraph flows down to all subcontracts, except the authority of the Inspector General
under paragraph (d)(1)(ii) does not flow down; and(ii) Those clauses listed in this paragraph (e)(1). Unless otherwise indicated below, the extent of the flow down shall be as
required by the clause(A) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509).
(B) 52.203-15, Whistleblower Protections Under the American Recovery and Reinvestment Act of 2009 (Jun 2010) (Section
1553 of Pub. L. 111-5).
(C) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab
and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).
(D) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.
(Aug 2019) (Section 889(a)(1)(A) of Pub. L. 115-232).
(E) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer
further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $700,000($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts thatoffer subcontracting opportunities.
(F) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).
(G) 52.222-26, Equal Opportunity (Sept 2016) (E.O. 11246).
(H) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).
(I) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul2014) (29 U.S.C. 793).
(J) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). Flow
down required in accordance with paragraph (f) of FAR clause 52.222-40.
(H) 52.222-41, Service Contract Labor Standards (Aug 2018) (41 U.S.C.chapter 67).
(L) ___(1) 52.222-50, Combating Trafficking in Persons (Jan 2019) (22 U.S.C. chapter 78 and E.O 13627).
___(2) Alternate I (Mar2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O 13627).
(M) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance,
Calibration, or Repair of Certain Equipment-Requirements (May 2014) (41 U.S.C. chapter 67).
(N) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain
Services-Requirements (May2014) (41 U.S.C. chapter 67).
(O) 52.222-54, Employment Eligibility Verification (Oct 2015) (Executive Order 12989).
(P) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).
(Q) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2017) (E.O. 13706).
(R)(1) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).
(2) Alternate I (Jan 2017) of 52.224-3.
(S) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as
amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).
(T) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792). Flow down
required in accordance with paragraph (e) of FAR clause 52.226-6.
(U) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10
U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.