      
    

  

       

      



             
  

      
                       
 

  
 
    

                





           

     






  
                          

 

  



   

 




       







 

    





    

     

  

  

  

   

     
















 

         






  

     
     

     

   

                                        

       

              
                                          

               
            
              
        

          
                          
    

(b) (4), (b) (6)   

(b) (6)
  

(b) (6)

  

(b) (4), (b) (6)    
       

   

    

1

DRIVE EZ-BAA CONTRACT
PART I.

THE SCHEDULESECTION A.

BACKGROUND

In 2018, the Biomedical Advanced Research and Development Authority (BARDA) established the Division of
Research, Innovation, and Venture (DRIVe). The mission of DRIVe is to encourage agile business practices,
accelerate biomedical innovations, and improve the availability of transformative products & technologies to protect
Americans from natural and intentional health security threats. The following contract and the Statement of Work(addressed in Section C), further the mission and goals of DRIVe.
SECTION B.
B. 1.

SUPPLIES OR SERVICES AND PRICE/COSTPRICE

FIRM FIXED PRICE: The firm fixed price of the base period of the contract is $683,500.
.
PROJECT DESCRIPTIONPERIOD OF
QUANTITYUNIT
CONTRACTLINE ITEMPERFORMANCE
NO. (CLIN)
xMAP® SARS-CoV-2 Multi23 September 2020
0001
Antigen Antibody Typing
1
JOB
Assay
31 January 2021

UNIT PRICE$683,500(b) (4)B. 2.

ADVANCE UNDERSTANDINGS

a. Sharing of contract deliverables within United States Government (USG)
In an effort to build a robust medical countermeasure pipeline through increased collaboration, theGovernment may share technical deliverables with Government entities responsible for Medical
Countermeasure Development. In accordance with recommendations from the Public Health Emergency
Medical Countermeasure Enterprise (PHEMCE) Review, agreements established in the Integrated Portfolio
Advisory Committee (PAC) Charter, and agreements between BARDA and the Department of Defense, theNational Institutes of Health, the Centers for Disease Control, and the FDA, BARDA may share technicaldeliverables and test results created in the performance of this Contract with colleagues within the
PHEMCE as well as within the Department of Health and Human Services (DHHS). This advanceunderstanding does not authorize the Government to share financial information outside of the United States
Government. The Contractor is advised to review the terms of FAR 52.227-14 Rights in Data – General,
regarding the Government’s rights to data produced during the course of performance of this Contract.

b. Approval of Human and Animal Protocols
This contract:1.
2.

Will or X Will Not include clinical trials (e.g. human protocols); andWill or X Will Not include non-clinical trials (e.g. animal protocols).

Accordingly, if checked to indicate either class of studies is not included under the subject contract, all of
the corresponding clinical and non-clinical clauses, terms, and obligations included in this document are
hereby self-deleted.

3

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

c. Rights in Data
See Section I – Contract Clauses
SECTION C.

DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

C.1. STATEMENT OF WORKSee Section J – Attachment 1 (Statement of Work) as agreed upon by the Government and Contractor, and theReporting Requirements outlined by “DRIVe Digital Resources” accessed via www.drive.hhs.gov.
C.2 REGULATORY ACTIVITIESThe Contractor shall submit to the COR pre-submission documents, submission documents, results documents, andall proposed regulatory filing documents with the FDA before submission to the FDA, if possible, and if not, then at
the time of submission to the FDA at the latest.
C.3 QUALITYThe Contractor may be required to establish and maintain a Quality Management System for the proposed effort
with sufficient content to include but not limited to the elements contained in the Code of Federal Regulations Title
21 Part 820.
The Contractor may be required to establish routine internal reviews of the proposed effort with documentation andevidence of the ability to maintain, and adhere to the Code of Federal Regulations Title 21 Part 820.
The Contractor may be required to subcontract for an independent audit of its system quality system adherence,
resolve any issues noted by the auditor, and provide the audit findings and resolutions to the Government.
SECTION D.

PACKAGING, MARKING, AND SHIPPINGAll deliverables required under this Contract shall be packaged, marked and shipped in accordance with
Government specifications and Section F. At a minimum, all deliverables shall be marked with the contract number
and Contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate
usable and acceptable condition.
Unless otherwise specified by the CO, delivery of reports to be furnished to the Government under this Contract(including invoices) shall be delivered to the CO and COR electronically along with a concurrent email notification
to the CO and COR (as defined in Section F.3. Electronic Submission) summarizing the electronic delivery.
SECTION E.

INSPECTION AND ACCEPTANCE

E.1. FAR 52.252-2, CLAUSES INCORPORATED BY REFERENCE (FEBRUARY 1998)
See Section I for a complete list of clauses incorporated by reference.

4E.2. DESIGNATION OF GOVERNMENT PERSONNEL
For the purpose of this Section E, the designated COR is the authorized representative of the CO. The COR willassist 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, modify or extend the period of
performance, or authorize reimbursement of any costs incurred during performance.
E.3. INSPECTION, ACCEPTANCE AND CONTRACT MONITORING
Inspection and acceptance of the product, services, and documentation called for herein shall be accomplished by
the CO or a duly authorized representative. Delivery, technical inspection and acceptance will be take place at alocation designated by the CO or at:
Office of the Assistant Secretary for Preparedness and Response
Biomedical Advanced Research and Development Authority
O’Neill House Office Building
Washington, DC 20515
At the discretion of the Government and independent of activities conducted by the Contractor, with 48 hours’ noticeto the Contractor, the Government reserves the right to conduct site visits and inspections related to this Contract onan as needed basis during normal business hours, including collection of product samples and intermediates held at thelocation of the Contractor, or its subcontractor. All costs reasonably incurred by the Contractor and subcontractor forsuch visit and/or inspection shall be allowable costs subject to the Allowable cost requirements in FAR Subpart 31.2.
The Contractor shall coordinate these visits and shall have the opportunity to accompany the Government on any
such visits. Under time-sensitive or critical situations, the Government reserves the right to suspend the 48 hour
notice to the Contractor. The areas included under the site visit could include, but are not limited to: security,
regulatory and quality systems, manufacturing processes and cGMP/GLP/GCP compliance related to activities funded
under this Contract.
If the Government, Contractor, or other party identifies any issues during an audit, the Contractor shall capture theissues, identify potential solutions, and provide a report to the Government for review and acceptance.
If issues are identified during the audit, the Contractor shall submit a report to the CO and COR within five(5) business days detailing the finding and corrective action(s) of the audit.
COR and CO will review the report and provide a response to the Contractor within ten (10) business days.
Once corrective action is completed, the Contractor will provide a final report to the CO and COR.
SECTION F.

DELIVERIES OR PERFORMANCE

F.1. ESTIMATED PERIOD OF PERFORMANCEThe estimated period of performance for this Contract shall be consistent with the dates set forth in Section B.2.
F.2. DELIVERABLES
Successful performance under this contract shall be deemed to occur upon completion of performance of the work
set forth in Attachment 1 of this contract and upon delivery and acceptance, as required by Attachment 1, by the
COR, and of each of the deliverables described in Section C and Section F below.
All deliverables and reporting documents listed within this Section shall be delivered electronically to the CO, theContract Specialist (CS), and the COR as well as in the designated eRoom (the Government’s SharePoint site)
unless otherwise specified by the CO.

5

Number

Deliverable

DescriptionDue
Due within 5 business days ofaward date, and within 30 days
after substantive changes are
made to locations or capabilities.

1

2

Work Location
Tracking

Kickoff Meeting

The Contractor shall submit a detailed
spreadsheet regarding locations where
work will be performed under thiscontract, including addresses, points ofcontact, and work performed per location,
to include any subcontractors, if
necessary.

The Contractor shall complete a Kickoff
meeting after contract award, either as avideoconference or an in-person meeting,to outline activities for the next 30 days.

Due within 2 business days of a
substantive change if the work
performed supports medical
countermeasure developmentthat addresses a threat that has
been declared a Public Health
Emergency by the HHS
Secretary or a Public Health
Emergency of International
Concern (PHEIC) by the WHO

Due within 10 days of award
date.

The Contractor shall provide an itinerary
and agenda at least 2 business days inadvance of meeting.

3

4

Project Plan

Product Development
Source Material and
Manufacturing Report

The Contractor shall submit a detailed
Project Plan, Gantt Chart, and Risk
Mitigation Plan outlining the goals,deliverables, strategies, and intended
pathway for the project.

The Contractor shall submit a detailed
spreadsheet regarding critical projectmaterials that are sourced from a location
other than the United States, sources, andmanufacturing sites. This includes, but is
not limited to:(1) Physical locations of sources of raw
and processed material by type ofmaterial; (2) location and nature of work
performed at manufacturing site; and (3)location and nature of non-clinical andclinical study sites.

6

Due within 10 days of awarddate.

Due within 30 days of award
date, and within 30 days after
substantive changes are made tosources or materials. The
Government will provide writtencomments to the ProductDevelopment Source Materialand Manufacturing Report
within 15 business days after
submission.
If corrective action isrecommended, Contractor must
address and document allconcerns raised by BARDA.

5

6

WeeklyTeleconferenceMonthly Reports

The Contractor shall participate in
teleconferences every week with BARDA
to discuss the performance of the contract.
The Contractor shall provide slides 24hours in advance of scheduled meetings.

The Contractor shall ubmit monthly
reports summarizing data and progress todate on each aim in the SOW.

Held weekly. Minutes provided
by Contractor within 3 businessdays of the meeting.

Due the 15th of the monthfollowing the preceding
reporting month. The COR and
CO will review the monthly
reports with the Contractor andprovide feedback.

Upon request of the Government, theContractor shall participate in a daily
check-in updates with the project staff(via teleconference or email).

7

Daily Check-In with
Project Staff for
COVID-19 Response

The updates will address key cost,schedule and technical updates. Daily
updates may be shared with senior
Government leaders during the COVID19 response and should be provided inboth a non-confidential and confidential
format.
Daily check-ins may occur on weekdays,
excluding federal holidays. Upon requestof the Government, check-ins may also
occur on weekends and on federal
holidays, provided at least 8 hours’ notice.

8

Sample Prototype

If applicable and available, the Contractor
shall deliver sample prototype/examples
to BARDA DRIVe for display purposes
ONLY. Prototype/examples are notintended for clinical or non-clinical uses.

9

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.

10

Product/Technology
Transition Strategy

If applicable, the Contractor shall submit a
1-2 page summary document containing a
Transition Strategy. The Transition
Strategy should include a strategic
business and technical plan for further
development and transitioning the product7

No agenda will be required forthe check-in.
No meeting minutes are
required.
Contractor will provide abulleted email update as soon as
possible following any check-in.

If applicable and available, theSample Prototype is due within
30 days of request

Draft Report and Final Reportdue on or before the completion
date of the contract.
If applicable, theProduct/Technology Transition
Strategy is due 30 days prior tocontract end date or 30 days
prior to the end of each year of
the Base Period, whicheveroccurs first.

and/or technology

11

Final Data Package

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

Due at least 15 days prior tocontract end date. Partial datasets may also be requested 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).

12

Supplemental
Technical Documents,
Raw Data, or Data
Analysis

The Contractor shall provide all raw data,
data analysis, or a data report to BARDA
DRIVe in accordance with FAR 52.22714.

Due upon request from the CO
or COR

13

Deliverables Arisingfrom FDA
Correspondence

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

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

a.

Periodic Document Review
The CO and COR reserve the right to request within the period of performance a non-proprietary
technical document for distribution within the Government. Contractor shall provide the technicaldocument within 10 business days of CO or COR request. Contractor can request additional time on an
as-needed basis. If edits are recommended, the Contractor must address, in writing, concerns raised by
the Government in writing.

b.

Deliverables Arising from FDA Correspondence1) FDA Meetingsi. 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).
ii. Contractor shall notify BARDA of upcoming FDA meetings within 24 hours of scheduling.
iii. The Contractor shall forward initial Contractor and FDA-issued draft minutes and final

8

minutes of any meeting with the FDA to the CO and COR within 5 business days of receipt.
All documents shall be duly marked as either “Draft” or “Final.”2) FDA Submissions & Correspondence
i. The Contractor will provide BARDA a copy of all applicable communications to the FDA
before submission to the FDA, if possible, and if not, then at the time of submission to the FDAat the latest. In addition, an electronic copy of the final FDA submissions will also need to besubmitted. All documents shall be duly marked as either “Draft” or “Final.”
1.

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.

2.

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

3.

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
their submission to, or email correspondence with, the FDA.

3) FDA Auditsi.

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 of nonconformance 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 fromsubcontractors that occur as a result of this contract or for this product. To the extent feasible,
the Contractor shall make arrangements for BARDA representative(s) to be present during
the final debrief by the regulatory inspector.

ii.

If draft documents are submitted to the COR for review, the COR will provide feedback toContractor within 10 business days of receipt, or sooner as necessary to address FDA
deadlines or requests.

iii.

If BARDA reviews draft documents, the Contractor shall revise as appropriate their
documents to address BARDA’s written concerns and/or recommendations prior to FDA
submission.
1. 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 business days’
advance notice.
2. Contractor shall provide copies of any FDA audit report received from subcontractors that
occur as a result of this contract or for this product within 5 business days of receiving
correspondence from the FDA, Subcontractor, or third party.
3. Within 15 business days of audit report, Contractor shall provide CO with a plan foraddressing areas of nonconformance, if any are identified.

9

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 documents shall be duly
marked as either “Draft” or “Final.” Contractor shall provide such written summary of any FDA
correspondence or engagement within 5 business days and submit to the CO and COR. The writtensummary shall include:
i. A tracking log of progress on regulatory submissions with the FDA, description of thesubmission, date of the submission, status of submission and next steps.
c.

Reporting and Meeting Details Specifics
Monthly Progress Report:
This report shall include a description of the activities during the reporting period, and the activities
planned for the ensuing reporting period. The first reporting period consists of the first full month of
performance plus any fractional part of the initial month. Thereafter, the reporting period shall consist ofeach calendar month.
The Contractor shall submit a Monthly Progress Report on or before the 15 th calendar day following the last
day of each reporting period and shall include the following:
A cover page that includes the contract number and title; the type of report and period that it covers; theContractor's name, address, telephone number, fax number, and e-mail address; and the date of submission;
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 and managing subcontractor performance andpersonnel changes);
SECTION II Part C: TECHNICAL PROGRESS - For each activity related to the Gantt chart, document theresults of work completed. The report shall be in sufficient detail to explain comprehensively the results
achieved. The description shall include pertinent data and/or graphs in sufficient detail to explain any
significant results achieved and preliminary conclusions resulting from analysis and scientific evaluation ofdata accumulated to date under the Contract. Include progress or status updates for all SOW tasks in eachof the monthly technical progress reports for which there is activity ongoing in that SOW task area(s) as
well as data for completed studies in any SOW task.
The report shall also include a description of problems encountered and proposed corrective action;differences between planned and actual progress, why the differences have occurred and what corrective
actions are planned; preliminary conclusions resulting from analysis and scientific evaluation of data
accumulated to date under the project;
SECTION II Part D: PROPOSED WORK - A summary of work proposed for the next reporting period andpreprints/reprints of papers and abstracts, and a current/updated Gantt chart;

10

SECTION II Part E: Outstanding Issues/Anticipated Areas of Concern - a list of any existing contractual
concerns that impact the technical scope of work, schedule, or pricing, as well as a list of potential or
anticipated areas of concern that may be encountered in the future months. A Monthly Progress Report will
not be required in the same month that the Annual or Final Reports are submitted;
Final Report(s) Requirement:This report shall include a summation of the activities during the reporting period, and the activities
planned for the ensuing reporting period. The first reporting period consists of the first full year of
performance plus any fractional part of the initial year. Thereafter, the reporting period shall consist of eachcalendar year.
The report shall include a cover page that includes the contract number and title; the type of report andperiod that it covers; the Contractor's name, address, telephone number, fax number, and e-mail address;
and the date of submission;
SECTION I-EXECUTIVE SUMMARY - A brief overview of the work completed and major
accomplishments achieved during the reporting period;
SECTION II-PROGRESSSECTION II Part A: OVERALL PROGRESS - A description of overall progress highlighting thesignificant accomplishments in the past year;
SECTION II Part B: MANAGEMENT AND ADMINISTRATIVE UPDATE – A description of all
meetings, conference calls, etc. that have taken place during the reporting period. Include progress on
administration and management issues (e.g. evaluating and managing subcontractor performance andpersonnel changes;
SECTION II Part C: TECHNICAL PROGRESS - For each activity, document the results of work
completed during the period covered in relation to proposed progress, effort and budget. The report shall bein sufficient detail to explain comprehensively the results achieved. The description shall include pertinent
data and/or graphs in sufficient detail to explain any significant results achieved and preliminary
conclusions resulting from analysis and scientific evaluation of data accumulated to date under theContract. The report shall include a description of problems encountered and proposed corrective action;differences between planned and actual progress, why the differences have occurred and what corrective
actions are planned; preliminary conclusions resulting from analysis and scientific evaluation of data
accumulated to date under the project. The report should summarize progress made under each SOW task.
Monthly Calls
A conference call between the COR and the Contractor’s Project Leaders/delegates and designees shalloccur monthly or as directed by the CO and COR. During this call the Contractor’s Project
Leaders/delegates and designees will discuss the activities since the last call, any problems that have arisen
and the activities planned until the next call takes place. The Contractor’s Project Leaders/delegates may
choose to include other key personnel on the conference call to give detailed updates on specific projects as
this may be requested by the COR.
Project Meetings
The Contractor shall participate in Project Meetings to coordinate the performance of the Contract, as
requested by the COR. These meetings may include face-to-face meetings (kick-off meetings, projectreviews, etc) with 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 theContractor’s facilities, and meetings with the Contractor and DHHS officials to discuss the technical,
regulatory, and ethical aspects of the program. Subject to the data rights provisions in this Contract, the11Contractor will provide data, reports, and presentations to groups of outside experts and Government
personnel as required by the CO and COR in order to facilitate review of contract activities.
Electronic copies of the conference call meeting minutes/summaries by the Contractor shall be provided via
e-mail to the CO and COR by the Contractor within five (5) business days after the conference call is held.
The COR will review these minutes for approval within 15 business days.
d.

Experimental Protocols
Notwithstanding guidance found under Article H in this document related to clinical protocols, theContractor shall submit all study/experiment/test plans, designs, and other protocols to BARDA for review
and comment before proceeding with a study.

F.3 SUBJECT INVENTION REPORTING REQUIREMENT
All reports and documentation required by FAR Clause 52.227-11 Patent Rights-Ownership by the Contractor,
including, but not limited to, the invention disclosure report, the confirmatory license, and the Government
support certification, one copy of an annual utilization report, and a copy of the final invention statement, shall be
submitted to the CO. A final invention statement (see FAR 27.303 (b)(2)(ii)) shall be submitted to the CO prior
to the closeout of the Contract.
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 CO at the address listed below.
SECTION G – CONTRACT ADMINISTRATION DATA
G.1. CONTRACTING OFFICER
The following CO will represent the Government for the purpose of this Contract:(b) (6)
Contracting Officer
HHS/ASPR/AMCG
O’Neill House Office Building
Washington, DC 20515(b) (6)
1)
2)

3)
4)

The CO is the only individual who can legally commit the Government to the expenditure of publicfunds. No person other than the CO can make any changes to the terms, conditions, general provisions, orother stipulations of this Contract.
The CO is the only person with the authority to act as agent of the Government under this contract. Only
the CO has authority to (1) direct or negotiate any changes in the Statement of Work; (2) modify orextend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to theContractor of any costs incurred during the performance of this Contract; (5) otherwise change any terms
and conditions of this Contract.
No information other than that which may be contained in an authorized modification to this Contract, duly
issued by the CO, which may be received from any person employed by the Government, other otherwise,
shall be considered grounds for deviation from any stipulation of this Contract.
The Government may unilaterally change its CO designation, after which it will notify the Contractor
in writing of such change.

G.2. CONTRACTING OFFICER'S REPRESENTATIVE (COR)
The following COR will represent the Government for the purpose of this contract:12

G.6. CONTRACT COMMUNICATIONS/CORRESPONDENCE (JULY 1999)
The Contractor shall identify all correspondence, reports, and other data pertinent to this Contract by imprinting
the contract number from Page 1 of the Contract.
G.7. GOVERNMENT PROPERTY
Contractor retains title to all property acquired as necessary to execute the work under this contract.
SECTION H – SPECIAL CONTRACT REQUIREMENTS
H.1 REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE
Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in BARDA funded
programs should report such matters to the DHHS 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 behandled confidentially. The e-mail address is Htips@os.dhhs.gov and the mailing address is:
Office of Inspector General
Department of Health and Human Services TIPS
HOTLINE
P.O. Box 23489 Washington, D.C. 20026
H.2 PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST ACTIVITIESThe Contractor acknowledges that U.S. Executive Orders and Laws, including but not limited to 13224 and P.L.
107-56, prohibit transactions with, and the provision of resources and support to, individuals and organizations
associated with terrorism. It is the legal responsibility of the Contractor to ensure compliance with these
Executive Orders and Laws. This clause must be included in all subcontracts issued under this Contract.
H.3 IDENTIFICATION AND DISPOSITION OF DATAThe Contractor will be required to provide certain data generated under this Contract to DHHS. DHHS reserves theright 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 the time specified by
the FDA.
H.4 EXPORT CONTROL NOTIFICATION
Contractors are responsible for ensuring compliance with all export control laws and regulations that may be
applicable to the export of and foreign access to their proposed technologies. Contractors may consult with the
Department of State with any questions regarding the International Traffic in Arms Regulation (ITAR) (22 C.F.R.
Parts 120-130) and /or the Department of Commerce regarding the Export Administration Regulations (15 C.F.R.
Parts 730-774).
H.5 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 commencementof any work, the Contractor agrees to notify the CO promptly that, to the best of its knowledge and belief, noactual 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 be made within five (5)15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 thisContract for convenience, in whole or in part, if the CO deems such termination necessary to avoid anorganizational conflict of interest. If the Contractor was aware of a potential organizational conflict of interest
prior to award or discovered an actual or potential conflict after award and did not disclose it or misrepresented
relevant information to the 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 this Contract.
H.6 INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL
CONFLICTS OF INTEREST
The 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 that investigators (defined as
the principal investigator and any other person who is responsible for the design, conduct, or reporting of research
funded under BARDA contracts) will not be biased by any conflicting financial interest.
As required by 45 C.F.R. Part 94, the Contractor shall, at a minimum:
a. 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 theregulations.
b. Designate an official(s) to solicit and review financial disclosure statements from each investigator participatingin BARDA-funded research. Based on established guidelines consistent with the regulations, the designatedofficial(s) must determine whether a conflict of interest exists, and if so, determine what actions should be taken to
manage, reduce, or eliminate such conflict. A conflict of interest exists when the designated official(s) reasonably
determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or
reporting of the BARDA-funded research. The Contractor may require the management of other conflicting
financial interests in addition to those described in this paragraph, as it deems appropriate. Examples of conditions
or restrictions that might be imposed to manage actual or potential conflicts of interests are included in 45 C.F.R.
Part 94, under Management of Conflicting Interests.
c. Require all financial disclosures to be updated during the period of the award, either on an annual basis or as newreportable Significant Financial Interests are obtained.
d. Maintain records, identifiable to each award, of all financial disclosures and all actions taken by the Contractor
with respect to each conflicting interest 3 years after final payment or, where applicable, for the other time periods
specified in 48 C.F.R. Part 4, subpart 4.7, Contract Records Retention.
e. Establish adequate enforcement mechanisms and provide for sanctions where appropriate.
If a conflict of interest is identified, the Contractor shall report to the CO, the existence of the conflicting interest
found. This report shall be made and the conflicting interest managed, reduced, or eliminated, at least on atemporary basis, within sixty (60) days of that identification.
If the failure of an investigator to comply with the conflict of interest policy has biased the design, conduct, or
reporting of the BARDA-funded research, the Contractor must promptly notify the 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 the Contractor 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 conflicts of interests in
BARDA-funded research, including a review of all records pertinent to compliance with 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 a16particular conflict of interest will bias the objectivity of the BARDA-funded research to such an extent that further
corrective action is needed or that the Contractor has not managed, reduced, or eliminated the conflict of interest.
The issuance of a Stop Work Order by the CO may be necessary until the matter is resolved.
If the CO determines that BARDA-funded clinical research, whose purpose is to evaluate the safety or effectivenessof a drug, medical device, or treatment, has been designed, conducted, or reported by an investigator with a conflictof interest that was not disclosed or managed, the Contractor must require disclosure of the conflict of interest ineach public presentation of the results of the research.
H.7 NEEDLE DISTRIBUTION
The Contractor shall not use contract funds to carry out any program of distributing sterile needles or syringes
for the hypodermic injection of any illegal drug.
H.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 CONFIDENTIALITY OF INFORMATION

a. Confidential information, as used in this article, means information or data of a personal nature about anindividual, or proprietary information or data submitted by or pertaining to an institution or organization.
b. 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 the performance of the contract. Failure
to agree will be settled pursuant to the "Disputes" clause.
c. If it is established elsewhere in this Contract that information to be utilized under this Contract, or a portion
thereof, is subject to the Privacy Act, the Contractor will follow the rules and procedures of disclosure set forthin the Privacy Act of 1974, 5 U.S.C. 552a, and implementing regulations and policies, with respect to systemsof records determined to be subject to the Privacy Act.
d. Confidential information, as defined in paragraph (a) of this article, shall not be disclosed without the priorwritten consent of the individual, institution, or organization.
e. Whenever the Contractor is uncertain with regard to the proper handling of material under the Contract, or if thematerial in question is subject to the Privacy Act or is confidential information subject to the provisions of thisarticle, the Contractor should obtain a written determination from the CO prior to any release, disclosure,dissemination, or publication.
f. The provisions of paragraph (d) of this article shall not apply to conflicting or overlapping provisions in other
Federal, State or local laws.
H.10 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; allcommunications and correspondence with regulatory agencies and bodies to include all audit
observations, inspection reports, milestone completion documents, and all Offeror commitments andresponses. Contractor shall provide the Government with an electronic copy of all correspondence andsubmissions to the FDA within 5 business days of receipt. The Government shall acquire unlimited rights
to all data funded under this contract in accordance with FAR Subpart 27.4 and FAR Clause 52.227-14.

17

H.11 [Reserved]
H.12 ACKNOWLEDGMENT OF FEDERAL FUNDING
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 andother documents. This requirement is in addition to the continuing requirement to provide an acknowledgment of
support and disclaimer on any publication reporting the results of a contract funded activity.
Publication and Publicity
No information related to data obtained under this Contract shall be released or publicized without providing
BARDA with at least one (1) business day advance notice and an opportunity to review 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 other documents. Contractors are required to state:(1) The percentage and dollar amounts of the total program or project costs financed with Federal money and;(2) The percentage and dollar amount of the total costs financed by non-governmental sources. For purposes ofthis Contract "publication" is defined as an issue of printed material offered for distribution or any
communication or oral presentation of information, including any manuscript or scientific meeting abstract. Any
publication containing data generated under this Contract must be submitted for BARDA review no less than
thirty (30) calendar days for manuscripts and fifteen (15) calendar days for abstracts
before submission for public presentation or publication. Contract support shall be acknowledged in all such
publications substantially as follows:"This project has been funded in whole or in part with Federal funds from the Department of Health and Human
Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research andDevelopment Authority, under Contract No. 75A50120C00179.”
Press Releases
Misrepresenting contract results or releasing information that is injurious to the integrity of BARDA may beconstrued as improper conduct. Press releases shall be considered to include the public release of information to
any medium, excluding peer-reviewed scientific publications. With the exception of ad-hoc press releases
required by applicable law or regulations, the Contractor shall ensure that the COR has received an advance copyof any press release related to the contract not less than one (1) business day prior to the issuance of the press
release.
The Contractor shall acknowledge the support of the Department of Health and Human Service, Office of theAssistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development
Authority, whenever publicizing the work under this contract in any media by including an acknowledgment
substantially as follows:"This project has been funded in whole or in part with Federal funds from the Department of Health and Human
Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research andDevelopment Authority, Division of Research Innovation and Ventures under Contract No. 75A50120C00179.”
a. Contractor Use of the Powered by DRIVe Logo1)

For the limited purposes of the Contractor’s participation related to the subject DRIVe contract, Contractor is18permitted to use the following logo (the “Logo”) for the period of performance of this Contract (or for a longer
period, if agreed between the parties), subject to the Contractor’s full performance of the terms and conditions of
the subject Contract and provided that Contractor shall cease to use the Logo immediately upon BARDA’s
request.

2)

The Contractor’s use of the term “Powered by DRIVe” shall be subject to DRIVe Brand Guidelines.

3)

Any other use of the DRIVe name, its Logo, service marks or trademarks, or any of its otherdistinguishable marks, whether registered or not, shall be limited to those granted by the express,
written permission of the BARDA. Those to whom such permission is granted must agree that
BARDA shall remain the final arbiter of the use of the mark or Logo.

b. BARDA Use of Contractor Logo
Contractor hereby grants BARDA/DRIVe the right to use Contractor’s corporate logo (and other artwork as agreed
to by the parties), for presentations, internal and external websites, and other reasonable 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).
H.13 [Reserved]
H.14 PRIVACY ACT APPLICABILITY
Notification is hereby given that the Contractor and its employees are subject to criminal penalties for violation of
the Privacy Act to the same extent as employees of the Government. The Contractor shall assure that each of its
employees knows the prescribed rules of conduct and that each is aware that he or she can be subjected to criminal
penalty for violation of the Act. A copy of 45 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 of Records number
09-25-0200.
H.15 LABORATORY LICENSE REQUIREMENTS
The Contractor shall comply with all applicable requirements of Section 353 of the Public Health Service Act(Clinical Laboratory Improvement Act as amended) (42 U.S.C. 263a) and 42 CFR Part 493. This requirement shallalso be included in any subcontract for services under the Contract.
H.16 QUALITY ASSURANCE (QA) AUDIT REPORTS
BARDA reserves the right to participate in QA audits as related to activities funded under this Contract. Uponcompletion of the audit/site visit the Contractor shall provide a report capturing the findings, results and next
steps in proceeding with the subcontractor. If action is requested of the subcontractor, detailed concerns for19

addressing areas of non-conformance to FDA regulations for GLP, GMP, or GCP guidelines, as identified in theaudit report, must be provided to BARDA. The Contractor shall provide responses from the subcontractors toaddress these concerns and plans for corrective action execution.
Contractor shall notify CO and COR of upcoming, ongoing, or recent audits/site visits of
subcontractors as part of weekly communications.
Contractor shall notify the COR and CO within five (5) business days of reportcompletion.
H.17 BARDA AUDITS
Contractor shall accommodate periodic or reasonable ad hoc site visits during normal business hours by theGovernment with forty-eight (48) hours advance notice. If the Government, the Contractor, or other parties
identifies any issues during an audit, the Contractor shall capture the issues, identify potential solutions, andprovide a report to the Government.
If issues are identified during the audit, Contractor shall submit a report to the CO and COR
detailing the finding and corrective action(s) within 10 business days of the audit.
COR and CO will review the report and provide a response to the Contractor with ten (10) businessdays.
Once corrective action is completed, the Contractor will provide a final report to the CO and COR.
H.18 RESTRICTION ON EMPLOYMENT OF UNAUTHORIZED ALIEN WORKERS
The Contractor shall not use Contract funds to employ workers described in Section 274A (h)(3) of the
Immigration and National Act, which reads as follows:“(3) Definition of unauthorized alien – As used in this Section, the term ‘unauthorized alien’ with respect to theemployment of an alien at a particular time, that the alien is not at that time either an alien lawfully admitted forpermanent residence, or (B) authorized to be so employed by this Act or by the Attorney General.”
H.19 NOTIFICATION OF CRITICAL PROGRAMMATIC CONCERNS, RISKS, OR POTENTIAL
RISKS
If any action occurs that creates a cause for critical programmatic concern, risk, or potential risk to BARDA or
the Contractor an Incident Report shall be delivered to BARDA.
Within 48 hours of activity or incident or within 24 hours for a security related activity or incident,
Contractor must notify BARDA.
Additional updates due to COR and CO within 48 hours of additional developments.
Contractor shall submit within 5 business days a Corrective Action Plan (if deemed necessary
by either party) to address any potential issues.
If corrective action is deemed necessary, Contractor must address in writing its consideration of concerns raised by
BARDA within 5 business days of receiving comments by BARDA.
H.20 [Reserved]
H.21 DISSEMINATION OF INFORMATION (May 2004)
Other than scientific and technical data for which the Contractor can assert a copyright under FAR Clause 52.22714 (c), no information related to data obtained under this Contract shall be released or publicized without the priorwritten consent of the CO. In the event that the Contractor seeks to publicize scientific and technical data, thecontractor shall provide BARDA, through the COR, with a minimum of thirty (30) business days to review theparticular scientific and technical data prior to publication.

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H.22 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 theContractor and any affected subcontractor(s) are granted a certificate of registration or are authorized to workwith 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 Select Agents under thisContract, the institution must provide information satisfactory to the Government 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 andwill be administered on behalf of all Select Agent work sponsored by these funds before using these funds for any
work directly involving the Select Agents. The Contractor must provide information addressing the following key
elements appropriate for the foreign institution: safety, security, training, procedures for ensuring that only
approved/appropriate individuals have access to the Select Agents, and any applicable laws, regulations andpolicies equivalent to 42 C.F.R. Part 73. The Government will assess the policies and procedures forcomparability 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 of Select Agents. This includes summaries ofsafety, security, and training plans, and applicable laws, regulations, and policies. For the purpose of security risk
assessments, the Contractor must provide the names of all individuals at the foreign institution who will haveaccess to the Select Agents and procedures for ensuring that only approved and appropriate individuals haveaccess to Select Agents under the Contract.
Listings of HHS select agents and toxins, biologic agents and toxins, and overlap agents or toxins as well as
information about the registration process, can be obtained on the Select Agent Program Web site athttps://www.selectagents.gov/
H.23 MANUFACTURING STANDARDSThe Good Manufacturing Practice Regulations (GMP) (21 C.F.R. Part 820) will be the standard to be applied for
manufacturing, processing, packaging, storage and delivery of this product.
If at any time during the life of the Contract, the Contractor fails to comply with GMP in the manufacturing,processing, packaging, storage, stability and other testing of the manufactured drug substance or product anddelivery of this product and such failure results in a material adverse effect on the safety, purity or potency of the
product (a material failure) as identified by the FDA, the Contractor shall have thirty (30) calendar days from thetime such material failure is identified to cure such material failure. If, within the thirty (30) calendar day period,
the Contractor fails to take such an action to the satisfaction of the Government Project Officer/COR, or fails toprovide a remediation plan that is acceptable to the COR, then the Contract may be terminated.
H.24 LABORATORY LICENSE REQUIREMENTS
The Contractor shall comply with all applicable requirements of 21 C.F.R. Part 58 and FDA Medical Device GMP
Guidance. This requirement shall also be included in any subcontract for services under the Contract.
H.25 SHARING RESEARCH DATA

21

The Contractor's data sharing plan, due date to be determined at contract award, is hereby incorporated by reference.
The Contractor agrees to adhere to its plan and shall request prior approval of the CO for any changes in its plan.
BARDA endorses the sharing of final research data to serve health. This contract is expected to generate researchdata that must be shared with the public and other researchers.
BARDA recognizes that data sharing may be complicated or limited, in some cases, by institutional policies, local
IRB rules, as well as local, state and Federal laws and regulations, including the Privacy Rule (see HHS-publisheddocumentation on the Health Information Privacy at http://www hhs.gov/ocr/privacy/index.html). The rights andprivacy 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.
H.26 PUBLIC ACCESS TO ARCHIVED PUBLICATIONS RESULTING FROM ASSISTANT
SECRETARY FOR PREPAREDNESS AND RESPONSE (ASPR) FUNDED RESEARCHAll ASPR-funded investigators shall submit to the National Institutes of Health (NIH) National Library ofMedicine's (NLM) PubMed Central (PMC) an electronic version of the author's final manuscript, upon acceptancefor publication, of any peer-reviewed scientific publications resulting from research supported in whole or in partwith Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for
Preparedness and Response. ASPR defines the author's final manuscript as the final version accepted for journal
publication, and includes all modifications from the publishing peer review process. The PMC archive will preserve
permanently these manuscripts for use by the public, health care providers, educators, scientists, and ASPR. The
Policy directs electronic submissions to the NIH/NLM/PMC: http://www.pubmedcentral nih.gov.
H.27 [Reserved]
H.28 [Reserved]
H.29 CLINICAL TERMS OF AWARD
In addition to those terms and conditions outlined under applicable HHSAR clauses incorporated by reference bySection I of this Contract, the following clinical terms of award detail an agreement between the BARDA and theContractor; they apply to all contracts involving clinical research.
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 and should be addressed by
the contractor. https://www hhs.gov/ohrp/
Any updates to clinical studies (enrollment, technical results, etc) are to be addressed in the Monthly and Annual
Progress Reports, as well as technical monthly calls. The Contractor shall advise the COR or designee in writing
and via electronic communication in a timely manner of any issues potentially affecting contract performance.
i. Safety and Monitoring Issuesa.

Institutional Review Board or Independent Ethics Committee Approval

22

Before award and then with the annual progress report, the Contractor must submit to BARDA a copy ofthe current IRB-or IEC-approved informed consent document, documentation of continuing review andapproval and the OHRP federal wide assurance number for the institution or site.
If other institutions are involved in the research (e.g., a multicenter clinical trial or study), each institution’s
IRB or IEC must review and approve the protocol. They must also provide BARDA initial and annual
documentation of continuing review and approval, including the current approved informed consent
document and federal wide number.
The Contractor must ensure that the application as well as all protocols are reviewed by their IRB or IEC.
To help ensure the safety of participants enrolled in BARDA-funded studies, the Contractor must provide
BARDA copies of documents related to all major changes in the status of ongoing protocols, including thefollowing:
All amendments or changes to the protocol, identified by protocol version number, date, or bothand dates it is valid.
All changes in informed consent documents, identified by version number, dates, or both and dates
it is valid.
Termination or temporary suspension of patient accrual.
Termination or temporary suspension of the protocol.
Any change in IRB approval.
Any other problems or issues that could affect the participants in the studies.
The Contractor must notify BARDA through the COR or CO of any of the above changes within five (5)working days by email or fax, followed by a letter signed by the institutional business official, detailingnotification of the change of status to the local IRB and a copy of any responses from the IRB or IEC.
If a clinical protocol has been reviewed by an institutional biosafety committee (IBC) or the NIH
Recombinant DNA Advisory Committee (RAC), the Contractor must provide information about the initialand ongoing review and approval, if any. See the NIH Guidelines for Research Involving Recombinant
DNA Molecules.
b.

Data and Safety Monitoring Requirements
BARDA strongly recommends independent safety monitoring for clinical trials of investigational drugs,
devices, or biologics; clinical trial of licensed products; and clinical research of any type involving morethan 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 ofCRO 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 inadvance of a DSMB board meetings for studies funded under this effort. BARDA reserves the right toparticipate in the DSMB board meetings on 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 madeavailable to BARDA upon receipt.
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 blood23

from a healthy individual for research purposes is no greater than 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 theappointment of one of the following:
Independent Safety Monitor – 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 othersafety issues.
Independent Monitoring Committee (IMC) or Safety Monitoring Committee (SMC) – a small groupof independent investigators and biostatisticians who review data from a particular study.
Data and Safety Monitoring Board – an independent committee charged with reviewing safety and trial
progress and providing advice with respect to study continuation, modification, and termination. The
Contractor may use an established BARDA DSMB or to organize an independent DSMB. All phase III
clinical trials must be reviewed by a DSMB; other trials may require DSMB oversight as well. Please refer
to: NIAID Principles for Use of a Data and Safety Monitoring Board (DSMB) For Oversight of Clinical
Trials Policy. 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 this contract.
When a monitor or monitoring board is organized, a description of it, its charter or operating procedures(including a proposed meeting schedule and plan for review of adverse events), and roster and curriculum
vitae from all members must be submitted to 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 monitoringgroup to the BARDA within thirty (30) days of reviews or meetings.
ii. BARDA Protocol Review Process Before Patient Enrollment Begins
BARDA 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 ensure the following (as applicable) are in place at each participating institution, prior topatient accrual or enrollment:
IRB- or IEC-approved clinical research protocol identified by version number, date, or both, including
details of study design, proposed interventions, patient eligibility, and exclusion criteria.
Documentation of IRB or IEC approval, including OHRP federal wide number, IRB or IEC
registration number, and IRB and IEC name.
IRB- or IEC- approved informed consent form/document, identified by version number, date, or bothand dates it is valid.
Plans for the management of side effects.
Procedures for assessing and reporting adverse events.
Plans for data and safety monitoring (see above) and monitoring of the clinical study site, pharmacy,
and laboratory.
Documentation that the Contractor and all study staff responsible for the design or conduct of theresearch have received training in the protection of human subjects.
Documentation to demonstrate that each of the above items are in place shall be submitted to BARDA) for24

evaluation and comment in conjunction with the protocol. Execution of clinical studies requires written
authorization from BARDA in accordance with this section of this contract.
iii. Investigational New Drug or Investigational Device Exemption Requirements
Consistent with federal regulations, applicable clinical research projects involving the use of investigational
therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose
other than that for which they were licensed) in humans under a research protocol must be performed undera 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 date the IND or IDE was filed with FDA, the FDA
IND or IDE number, any written comments from FDA, and the written responses to those comments.
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 aclinical trial.
The Contractor must notify BARDA if the FDA places the study on clinical hold and provide BARDA any
written comments from FDA, written responses to the comments, and documentation in writing that the holdhas been lifted.
The Contractor must not use grant or contract funds during a clinical hold to fund clinical 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 clinicalactivities for the clinical trial on clinical hold.
iv. Required Time-Sensitive Notificationa.

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:
Expedited safety report of unexpected or life-threatening experience or death. A copy of any
report of unexpected or life-threatening experience or death associated with the use of an INDdrug, which must be reported to FDA by telephone or fax as soon as possible but no later thanseven (7) days after the IND sponsor’s receipt of the information, must be submitted to BARDA
representative or COR within 24 hours of FDA notification.
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
from tests in laboratory animals that suggests a significant risk for human subjects, which must
be reported in writing to FDA as soon as possible but no later than 15 days after the IND
sponsor’s receipt of the information, must be submitted to the BARDA representative or COR
within 24 hours of FDA notification.
IDE reports of unanticipated adverse device effect. A copy of any reports of unanticipatedadverse device effect submitted to FDA must be submitted to BARDA representative or COR
within 24 hours of FDA notification.
Expedited safety reports. Sent to BARDA representative or the COR concurrently with thereport to FDA.
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.

25

b.

Safety reporting for research not performed under an IND or IDE:
Final decisions regarding ongoing safety reporting requirements for research not performed underan 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 letter to the Contractor’s ProjectManager, with a copy to the institutions’ office of sponsored programs, listing issues and appropriate
actions to be discussed.
c.

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

H.30 HEALTH RESOURCES PRIORITIES AND ALLOCATIONS SYSTEM
HHS reserves the right to exercise priorities and allocations authority with respect to this contract, to include rating
this order in accordance with 45 CFR Part 101, Subpart A—Health Resources Priorities and Allocations System.

26c.

The Contractor shall represent its size status in accordance with the size standard in effect at the timeof this re-representation 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-small-business-size-standardsd.

The small business size standard for a Contractor providing a product which it does not manufacture
itself, for a contract other than a construction or service contract, is 500 employees.

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 for Award Management (SAM) and its otherdata 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 thisclause 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 thiscontract, 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 tocomplete the following representation and submit it to the contracting office, along with the contract
number and the date on which the representation was completed:
The Contractor represents that it [ ] is, [X] is not a small business concern under NAICS Code 541715
assigned to this contract.
(End of clause)

FAR 52.204-21 Basic Safeguarding of Covered Contractor Information Systems (Jun 2016)(a) Definitions. As used in this clause-“Covered contractor information system” means an information system that is owned or operated by a contractor
that processes, stores, or transmits Federal contract information.
“Federal contract information” means information, not intended for public release, that is provided by or generated
for the Government under a contract to develop or deliver a product or service to the Government, but not including
information provided by the Government to the public (such as on public Web sites) or simple transactional
information, such as necessary to process payments.
“Information” means any communication or representation of knowledge such as facts, data, or opinions, in any
medium or form, including textual, numerical, graphic, cartographic, narrative, or audiovisual (Committee on
National Security Systems Instruction (CNSSI) 4009).
“Information system” means a discrete set of information resources organized for the collection, processing,maintenance, use, sharing, dissemination, or disposition of information (44 U.S.C. 3502).
“Safeguarding” means measures or controls that are prescribed to protect information systems.
(b) Safeguarding requirements and procedures.
(1) The Contractor shall apply the following basic safeguarding requirements and procedures to protect
covered contractor information systems. Requirements and procedures for basic safeguarding of covered
contractor information systems shall include, at a minimum, the following security controls:

31

(i) Limit information system access to authorized users, processes acting on behalf of authorizedusers, or devices (including other information systems).
(ii) Limit information system access to the types of transactions and functions that authorizedusers are permitted to execute.
(iii) Verify and control/limit connections to and use of external information systems.
(iv) Control information posted or processed on publicly accessible information systems.
(v) Identify information system users, processes acting on behalf of users, or devices.
(vi) Authenticate (or verify) the identities of those users, processes, or devices, as a prerequisite toallowing access to organizational information systems.
(vii) Sanitize or destroy information system media containing Federal Contract Information before
disposal or release for reuse.
(viii) Limit physical access to organizational information systems, equipment, and the respective
operating environments to authorized individuals.
(ix) Escort visitors and monitor visitor activity; maintain audit logs of physical access; and control
and manage physical access devices.
(x) Monitor, control, and protect organizational communications (i.e., information transmitted or
received by organizational information systems) at the external boundaries and key internalboundaries of the information systems.
(xi) Implement subnetworks for publicly accessible system components that are physically or
logically separated from internal networks.
(xii) Identify, report, and correct information and information system flaws in a timely manner.
(xiii) Provide protection from malicious code at appropriate locations within organizational
information systems.
(xiv) Update malicious code protection mechanisms when new releases are available.
(xv) Perform periodic scans of the information system and real-time scans of files from externalsources as files are downloaded, opened, or executed.
a.

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

(c) Subcontracts. The Contractor shall include the substance of this clause, including this paragraph (c), in
subcontracts under this contract (including subcontracts for the acquisition of commercial items, other thancommercially available off-the-shelf items), in which the subcontractor may have Federal contract information
residing in or transiting through its information system.
(End of clause)
FAR 52.227-7 Patents – Notice of Government License (APR 1984)
The Government is obligated to pay a royalty applicable to the proposed acquisition because of a license agreement
between the Government and the patent owner. The patent number is ____ [Contracting Officer fill in], and theroyalty rate is ____ [Contracting Officer fill in]. If the offeror is the owner of, or a licensee under, the patent,
indicate below:
Owner
LicenseeIf an offeror does not indicate that it is the owner or a licensee of the patent, its offer will be evaluated by adding
thereto an amount equal to the royalty(End of clause)32I.2. ADDITIONAL HHSAR CONTRACT CLAUSES INCLUDED IN FULL TEXTHHSAR 352.231-70 – Salary Rate Limitation (December 18, 2015)
i. Pursuant to the current and applicable prior HHS appropriations acts, payment of the direct salary of anindividual at a rate in excess of the Federal Executive Schedule Level II in effect on the date Government
funding was obligated.
ii. For purposes of the salary rate limitation, the terms “direct salary,” “salary”, and “institutional base salary”,
have the same meaning and are collectively referred to as “direct salary”, in this clause. An individual’s directsalary is the annual compensation that the Recipient pays for an individual’s direct effort (costs) under thecontract. Direct salary excludes any income that an individual may be permitted to earn outside of duties to
the Recipient. Direct salary also excludes fringe benefits, overhead, and general and administrative expenses(also referred to as indirect costs or facilities and administrative [F&A] costs).
Note: The salary rate limitation does not restrict the salary that an organization may pay an individual working
under a Government contract, order, or OTAR; it merely limits the portion of that salary that may be paid with
Federal funds.
iii. The salary rate limitation also applies to individuals under Sub-Recipient Agreements except to the extent thatthat a Sub-Recipient Agreement is awarded on a fixed-price basis without analysis of labor costs. If this is amultiple-year contract, it may be subject to unilateral modification by the CO to ensure that an individual is not
paid at a rate that exceeds the salary rate limitation provision established in the HHS appropriations act ineffect when the expense is incurred regardless of the rate initially used to establish Agreement funding.
iv. See the salaries and wages pay tables on the U.S. Office of Personnel Management Web site for Federal
Executive Schedule salary levels that apply to the current and prior periods(End of clause)33

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS
SECTION J - LIST OF ATTACHMENTS
The following documents are attached and incorporated in this contract:

1.
2.
3.

Statement of Work, dated 10 September 2020
Sample Invoice/Financial Request Instructions
Schedule of Payments

PART IV - REPRESENTATIONS AND INSTRUCTIONSSECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORSThe following documents are incorporated by reference in this contract:a.
b.

Animal Research Assurance Identification Numbers: To be provided prior to study execution.
Human Subjects Assurance Identification Numbers: To be provided prior to study execution.

Pursuant to 45 CFR part 46, Protection of Human Research Subjects, the Contractor shall not expend funds under
this award for research involving human subjects or engage in any human subject research activity prior to theContracting Officer’s receipt of a certification that the research has been reviewed and approved by theInstitutional Review Board (IRB) registered with OHRP. This restriction applies to all collaborating sites, whether
domestic or foreign, and subcontractors. The Contractor must ensure compliance by collaborators andsubcontractors.

34

Attachment 1
Biomedical Advanced Research and Development Authority (BARDA)
Broad Agency Announcement BAA-20-100-SOL-0002

xMAP® SARS-CoV-2 Multi-Antigen
Antibody Typing Assay
Area of Interest #4.1 (COVID-19)
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,
and facilities not otherwise provided by the government under the terms of this contract, as needed
to perform 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 researchand development (R&D) contract and the complexities inherent in this and prior programs, atdesignated milestones 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 tochange the product, process, schedule, or events to add or delete part or all of these elements as theneed arises.
Overall Objectives and Scope(b) (4)

(b) (4)36

(b) (4)PROGRAM MANAGEMENT

The contractor shall provide the following as outlined below:a)

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;b)

A Principal Investigator (PI) or Project Manager (PM) responsible for project management,
communication, tracking, monitoring, and reporting on status, progress, and modifications to
the project requirements, deliverables and timelines, including projects undertaken bysubcontractors;c)

A PM with responsibility for monitoring and tracking day-to-day progress and timelines ofdeliverables, coordinating communication and project activities, costs incurred, and program
management;d)

A BARDA liaison (maybe be the PM) with responsibility for effective communication with theContracting Officer (CO), Contract Specialist (CS), and Contracting Officer’s Representative(COR);e)

Administrative and legal staff capable of developing compliant subcontracts, consulting, andother legal agreements, while also ensuring timely acquisition of all proprietary rights, including
intellectual property (IP) rights and reporting all inventions made in the performance of thecontract;f)Administrative staff capable of financial management and reporting on all activities conducted by
the contractor and any subcontractors;g)Contract Review Meetings:
The contractor shall participate in regular meetings to coordinate and oversee the contracteffort jointly with the CO, CS, and COR. Such meetings may include, but are not limited to,the following:-

Meeting with the contractors and subcontractors to discuss clinical manufacturing
progress, product development, product assay development, scale-up manufacturing
development, clinical sample assay development, preclinical/clinical study designs andregulatory issues.

37-

Meeting with individual contractors and other government officials to discuss thetechnical, regulatory, and ethical aspects of the program.

-

Meeting with technical consultants to discuss technical data provided by the contractor.

h)

The contractor shall participate in teleconferences, daily to weekly, with the CO, CS, and COR to
discuss the performance of the contract, unless otherwise directed. Teleconferences or additional
face-to-face meetings may be more frequent at the request of the CO.

i)Gantt Chart
Within 10 calendar days of the effective date of the contract, the contractor shall submit afirst draft of an updated Gantt Chart to the CO, CS and COR for review. The Gantt Chart
shall be incorporated into the contract and will be used to monitor performance. The
contractor shall include the key milestones, deliverables, and Go/No-Go decision gates.

j)Project Management Plan
In the management of this contract, the contractor is encouraged to utilize ProjectManagement tools/techniques to track and monitor the cost and schedule of the project. The
contractor and the government agree that at a minimum, the contractor shall utilize the costand schedule tools/techniques in the contract deliverable for project management purposes.

k)Risk Management Plan
The contractor shall develop a risk management plan within 30 days of contract award
highlighting potential problems or issues that may arise during the life of the contract,
including the impact on cost, schedule, and performance. Appropriate remediation plans.
should reference relevant work segments where appropriate. Updates to this plan shall be
included, at a minimum, in the monthly Project Status Report.

l)Monthly and Annual Reports
The contractor shall deliver Project Status Reports on a monthly basis. The reports shalladdress the items below cross referenced to the SOW or other Project Management Plantool(s):m)-

Executive summary highlighting the progress, issues, and relevant manufacturing,
non-clinical, clinical, and regulatory activities.

-

Progress in meeting contract deliverables, detailing the planned progress and actual
progress during the reporting period, explaining any differences between the two andcorrective steps.

-

Updated Risk Management Plan (when appropriate).

-

One-month rolling forecast of planned activities.

-

Progress of regulatory submissions.

Data Management
The contractor shall:-

Develop and implement data management and quality control systems/procedures,
including transmission, storage, confidentiality, and retrieval of all contract data.

38-

Provide for the statistical design and analysis of data resulting from the research.

-

Provide raw data or specific analyses of data generated with contract funding to the CO,CS, and COR, upon request.

REGULATORYThe contractor shall perform the following as outlined below:a)Engage the Food and Drug Administration (FDA) on a path to support the use of the product for the
specific indication.

b) Prepare materials for and requesting, scheduling, and participating in all meetings with the FDA,
including meetings to review all data packages.
c)Provide BARDA with (1) initial draft minutes and final draft minutes of any formal meeting with the
FDA, and (2) final draft minutes of any informal meeting with the FDA.

FACILITIES, EQUIPMENT, & OTHER RESOURCES
The contractor shall provide equipment, facilities, and other resources required for implementation of the
SOW to comply with all Federal and HHS regulations in:a)

The humane care and use of vertebrate animals.

b) The acquisition, handling, storage, and shipment of potentially dangerous biological andchemical agents, including select agents under biosafety levels required for working with thebiological agents under study.

39

Attachment 3
Schedule of Payments
Pursuant to FAR 52.232-2, partial payments will be made upon receipt and acceptance of a deliverable andacceptable invoice for partial delivery of work, as outlined in the table below:
Partial Payment

Deliverable Title

Brief Description of Deliverable(b) (4)

Partial Payment
Amount*The partial payment succeeding the Project Plan (outlined in Section F of the contract) will not be paid until the
Project Plan is received and accepted by the Contracting Officer and Contracting Officer’s Representative.
**The partial payment preceding the (1) Final Report and (2) Final Data Package (outlined in Section F of thecontract) will not be paid until both the (1) Final Report and (2) Final Data Package are received and accepted by theContracting Officer and Contracting Officer’s Representative.

41