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 $628,071.
.
CONTRACTPROJECT DESCRIPTIONPERIOD OF
QUANTI
UNIT
LINE ITEMPERFORMANCE
TY
NO. (CLIN)
Chembio Diagnostics Inc - R&D
06 July-20200001
of a SARS-CoV-2 Ag System
1JOB
15 December - 2020
Reports & Other Deliverables

UNIT
PRICE

$628,071

Through negotiations, the Government and Contractor agreed that a total price of (b) (4)would be a realistic
and reasonable estimate of Contractor’s actual costs of performance. Accordingly, in return for successful
completion and delivery of CLIN 0001, the Government’s portion will be $628,071.
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); and☐ Will 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 are3hereby self-deleted.
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 for review and comment, pre-submission documents, submission
documents, results documents, and all proposed regulatory filing documents with the FDA.
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 (b) (4) 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 (b)(4)
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 (b) (4).
• 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

All documents shall be duly marked as either “Draft” or “Final.”2) FDA Submissions & Correspondence
i. The Contractor shall provide BARDA the opportunity to review and comment upon all
documents submitted to the FDA. In addition, an electronic copy of the final FDA submissions
will also need to be submitted. All documents shall be duly marked as either “Draft” or “Final.”
1.

If draft documents are submitted to the COR for review, the COR will provide
feedback to Contractor within (b) (4)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 (b) (4)oftheir 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 (b) (4)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 (b) (4)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 (b) (4)of a scheduled FDA audit orwithin (b) (4) of an ad hoc site visit/audit if the FDA does not provide (b) (4)’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 (b) (4)of receiving
correspondence from the FDA, Subcontractor, or third party.
3. Within (b) (4)of audit report, Contractor shall provide CO with a plan foraddressing areas of nonconformance, if any are identified.
Final FDA submissions shall be submitted to the CO and COR.

9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)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 with15

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 a
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.

16

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 (b) (4)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.
H.11 [Reserved]17

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 thirty (30) days advanced 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. _______.”
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 two (2) business days prior to the issuance of the press
release.
The Contractor shall acknowledge the support of the Department of Health and Human Service, Office of 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. _______.”
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 ispermitted 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

18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 foraddressing 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.

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•
•

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 (b) (4)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 (b) (4)of the audit.
COR and CO will review the report and provide a response to the Contractor with (b) (4).
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 (b) (4) 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 (b) (4) of additional developments.
Contractor shall submit within (b) (4)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 (b) (4)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.
H.22 REGISTRATION WITH THE SELECT AGENT PROGRAM FOR WORK INVOLVING THE
POSSESSION, USE, AND/OR TRANSFER OF SELECT BIOLOGICAL AGENTS OR TOXINS

20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
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.

22

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 bloodfrom 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)).

23

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) for
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.

24

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.

b.

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 than(b) (4)after the IND sponsor’s receipt of the information, must be submitted to BARDA
representative or COR within (b) (4) 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 (b) (4) after the IND
sponsor’s receipt of the information, must be submitted to the BARDA representative or COR
within (b) (4) 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 (b) (4) 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.

Safety reporting for research not performed under an IND or IDE:

25

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 (b) (4)byemail or fax, followed within (b) (4)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.29. FOREIGN TRANSFER OF ASSETS OR TECHNOLOGYThis clause shall remain in effect during the term of the Contract and for five (5) years thereafter.
a.

Definitions

AFFILIATES: Associated business concerns, non-profit organizations, or individuals if, directly or
indirectly, (1) either one controls or can control the other; or (2) a third party controls or can control both.
ASSET(S): Tangible or intangible manifestations of technologies having economic value and capable ofbeing conveyed between economic or Governmental entities that is the focus/scope of development by the
U.S. Government (“USG”) and Contactor in this Contract.
ASSET(S): Tangible or intangible manifestations of technologies having economic value and capable ofbeing conveyed between economic or Governmental entities that is the focus/scope of development by the
U.S. Government (the “USG”) and Contactor in this Contract.
FOREIGN FIRM OR INSTITUTION: A firm or institution organized or existing under the laws of acountry other than the United States of America (U.S.), its territories, or possessions. The term includes,
for purposes of this Contract, any agency or instrumentality of a foreign government; and firms, institutions
or business organizations which are owned or substantially controlled by foreign governments, firms,
institutions, or individuals.
TECHNOLOGY: Technical Data, Computer Software, manufactured materials and Subject Inventions
funded by the USG under this Contract. Technology also includes contractor know how and personnel
expertise, as well as other Assets necessary to assure successful completion of this Contract.

26

U.S. FIRM OR INSTITUTION: A firm or institution organized or existing under the laws of the UnitedStates, its territories, or possessions. The term includes, for purposes of this Contract, any agency or
instrumentality of the USG; and firms, institutions or business organizations which are owned or
substantially controlled by U.S. citizens, firms, institutions, governmental agencies or individuals.
b.

GeneralThe parties agree that research findings and technological developments made under this Contract
constitute an investment by the USG on behalf of its citizens in the interest of their economic and national
health security. These investments are made for the primary benefit of the citizenry of the United Stateswith those same benefits potentially accruing to the people of all nations. Therefore, the USG has afiduciary responsibility to protect the full invested value of the Assets and Technology developed under thisContract. The USG is also cognizant of the duty the Contractor has to its shareholders and otherstakeholders with a vested interested in the economic success of the Contractor. At times both parties areaware their respective interests may diverge. Therefore, in the course of conducting business though theContract, access to technology developments under this Contract by Foreign Firms or Institutions must be
carefully considered.
c.

Export Controls

Contractor agrees to comply with all applicable laws regarding export controls and not to export any Assetor Technology to any U.S. embargoed countries.
d.

Post-award Transfer of Ownership of Assets or Technology
The Contractor shall provide notice to the CO and COR within three (3) business days of any discussionsof a proposed transfer of ownership or establishment of a licensing agreement of any Asset or Technology
funded under this Contract from the Contractor to a Foreign Firm or Institution. Notice will also be given
within three (3) business days of any discussions of a proposed transfer of operational, corporate, or
economic control of Assets and Technology funded under this Contract to Foreign Firms or Institutions.
This Article shall not apply to transfers by the Contractor to Affiliated entities of the Contractor, as well as
technology transfers for the purposes of manufacturing in accordance with the Statement of Work.
Prior to transferring any Asset funded by the USG under this Contract, the Contractor should carefully
review the USG rights under FAR Subpart 42.12 pertaining to Novation, specifically FAR section 42.1204.
That provision provides that the USG may recognize a third party assignment only if the transfer of Assets
and Technology is determined to be in the USG’s interests. The Contractor should be aware that the USG
is under no obligation to recognize a successor in interest. If the CO determines that a transfer of Assets
and Technology may have adverse consequences to the economic well-being or national health security
interests of the U.S., the Contractor, and the CO shall jointly endeavor to find alternatives to the proposedtransfer which obviate or mitigate potential adverse consequences of the transfer but which may provide
substantially equivalent benefits to the Contractor.
In addition to the USG licensing rights to subject inventions and technical data funded under this Contract,
see FAR clause 52.227-11 (Patent Rights-Ownership by the Contractor) and FAR Clause 52.227-14 (Rights
in Data - General), the USG shall have a first right of refusal for the purchase of the Asset and/orTechnology funded under the Contract. The USG may waive this first right of refusal in writing submitted
to the Contractor within ninety (90) calendar days of the initial notification to the USG of the Contractor’s
intent to conduct any form of Asset or corporate transfer.
Except for transfers to affiliates of the Contractor, including those entities necessary to complete theStatement of Work, the Contractor shall provide written notice to the CO and COR of the scheduledtransfer to a Foreign Firm or Institution at least ninety (90) calendar days prior to the scheduled date oftransfer. Such notice shall cite this Article and shall specifically identify the Asset or Technology
proposed for the transfer and the general terms of the transfer. No transfer shall take place without

27

written concurrence from the CO.
e.

Transfer to a Prohibited Source

In the event of a transfer of an Asset and/or Technology by the Contractor to a Foreign Firm or Institution
which is identified as a Prohibited Source pursuant to FAR Subpart 25.7: (a) the USG may terminate thisContract for cause and (b) the license rights to the technical data and subject invention under the relevant
FAR IP Clauses (FAR Clause 52.227-11 and FAR Clause 52-227-14) shall survive the termination. Upon
request of the USG, the Contractor shall provide written confirmation of such licenses.
a.

Lower Tier Agreements

The Contractor shall include this Article, suitably modified, to identify the Parties, in all subcontracts orlower tier agreements, regardless of tier.

H.30. PRIORITIES & ALLOCATION SYSTEM
HHS reserves the right to exercise priorities and allocations authority with respect to this contract, toinclude rating this order in accordance with 45 CFR Part 101, Subpart A—Health Resources Priorities andAllocations System.

28

FAR

52.207-1

May 2006

FAR

52.209-6

Oct 2015

FAR

52.209-9

Jul 2013

FAR
FAR
FAR
FAR
FAR
FAR

52.209-10
52.210-1
52.215-2
52.215-8
52.215-14
52.215-22

Nov 2015
Apr 2011
Oct 2010
Oct 1997
Oct 2010
Oct 2009

FAR
FAR
FAR
FAR
FAR
FAR
FAR
FAR
FAR

52.215-23
52.219-8
52.219-28
52.222-21
52.222-25
52.222-35
52.222-36
52.222-37
52.222-38

Oct 2009
Oct 2014
Jul 2013
Apr 2015
Apr 1984
Oct 2015
Jul 2014
Feb 2016
Feb 2016

FAR

52.222-40

Dec 2010

FAR
FAR
FAR
FAR

52.222-41
52.222-50
52.222-54
52.223-6

Aug 2018
Mar 2015
Oct 2015
May 2001

FAR

52.223-18

Aug 2011

FAR

52.225-13

Jun 2008

FAR

52.225-25

Oct 2015

FAR

52.226-1

Jun 2000FAR

52.227-1

Dec 2007

FAR

52.227-2

Dec 2007

FAR
FAR

52.227-3
52.227-11

Apr 1984
May 2014

FAR

52.227-14

May 2014

FAR

52.227-15

Dec 2007

FAR

52.227-16

June 1987

Notice of Standard Competition
Protecting the Government's Interests When Subcontracting With
Contractors Debarred, Suspended, or Proposed for Debarment
Updates of Publicly Available Information Regarding
Responsibility Matters
Prohibition on Contracting with Inverted Domestic Corporations
Market Research
Audit and Records – Negotiation
Order of Precedence - Uniform Contract Format
Integrity of Unit Prices (Over the Simplified Acquisition Threshold
Limitations on Pass-Through Charges—Identification of
Subcontract Effort
Limitations on Pass-Through Charges
Utilization of Small Business Concerns
Post-Award Small Business Program Representation
Prohibition of Segregated Facilities
Affirmative Action Compliance
Equal Opportunity for Veterans ($150,000 or more)
Equal Opportunity for Workers with Disabilities
Employment Reports on VeteransCompliance with Veterans’ Employment Reporting Requirements
Notification of Employee Rights Under the National Labor
Relations Act
Service Contract Labor Standards.
Combating Trafficking in Persons
Employment Eligibility Verification
Drug-Free Workplace
Encouraging Contractor Policy to Ban Text Messaging While
Driving
Restrictions on Certain Foreign Purchases
Prohibition on Contracting with Entities Engaging in Certain
Activities or Transactions Relating to Iran—Representation andCertifications
Utilization of Indian Organizations and Indian-Owned Economic
Enterprises.
Authorization and Consent, Alternate 1 (APR 1984)
Notice and Assistance Regarding Patent and Copyright
Infringement
Patent Indemnity ALT 1
Patent Rights – Ownership by the Contractor
Rights in Data – General

Representation of Limited Rights Data and Restricted Computer
Software
Additional Data Requirements

30

HHSAR
HHSAR
HHSAR
HHSAR
HHSAR
HHSAR
HHSAR
HHSAR
HHSAR

352.227-70
352.233-70
352.237-75
352.231-70
352.239-74
352.270-5b352.270-6
352.270-9352.270-13

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

Publications and Publicity
Choice of Law (Overseas)
Key Personnel
Salary Rate Limitation
Electronic and Information Technology Accessibility
Care of Live Vertebrate Animals.
Restriction on Use of Human Subjects.
Non-discrimination for Conscience
Continued Ban on Funding Abortion and Continued Ban on Funding of
Human Embryo Research.

I.2. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXTThis contract incorporates the following clauses in full text. FEDERAL ACQUISITION REGULATION (FAR) (48
CFR CHAPTER 1) CLAUSES:FAR Clause 52.219-28, Post-Award Small Business Program Representation (July 2013)a.

Definitions . As used in this clause-Long-term contract means a contract of more than five years in duration, including options. However,
the term does not include contracts that exceed five years in duration because the period of
performance has been extended for a cumulative period not to exceed six months under the clause at
52.217-8, Option to Extend services, or other appropriate authority.
Small business concern means a concern, including its affiliates that is independently owned andoperated, not dominant in the field of operation in which it is bidding on Government contracts, andqualified as a small business under the criteria in 13 CFR part 121 and the size standard in paragraph(c) of this clause. Such a concern is "not dominant in its field of operation" when it does not exercise acontrolling or major influence on a national basis in a kind of business activity in which a number ofbusiness concerns are primarily engaged. In determining whether dominance exists, consideration
shall be given to all appropriate factors, including volume of business, number of employees, financial
resources, competitive status or position, ownership or control of materials, processes, patents, license
agreements, facilities, sales territory, and nature of business activity.

b.

If the Contractor represented that it was a small business concern prior to award of this contract, theContractor shall re-represent its size status according to paragraph (e) of this clause or, if applicable,
paragraph (g) of this clause, upon the occurrence of any of the following:(1) Within 30 days after execution of a novation agreement or within 30 days after
modification of the contract to include this clause, if the novation agreement was executed
prior to inclusion of this clause in the contract.
(2) Within 30 days after a merger or acquisition that does not require a novation or within 30
days after modification of the contract to include this clause, if the merger or acquisition
occurred prior to inclusion of this clause in the contract.
(3) For long-term contracts-(i) Within 60 to 120 days prior to the end of the fifth year of the contract; and(ii) Within 60 to 120 days prior to the date specified in the contract for exercising
any option thereafter.

32

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 [X] is, [ ] 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:

33

(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☐ Licensee
If 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)

34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)35

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.
4.

Statement of Work, dated 15 June 2020
Sample Invoice/Financial Request Instructions
Schedule of Payments
Reporting Deliverable Table - Contractor Locations and Product Development Source Material

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.

36Attachment 2
SAMPLE INVOICE REQUEST(a)Designated Billing Office Name and Address:
DHHS/OS/ASPR/BARDA
ATTN: Contracting Officer
O’Neill House Office Building
Washington, DC 20515(b)

Contractor’s Name:(c)

Invoice No.: __________________________________________________________(d)Date Invoice Submitted: ________________________________________________(e)Contract No.: _________________________________________________________(f)

Current Contract Period of Performance:_______________________________________
Contractor’s Address__________________________________________________________________________________________________________________________________________________(g)

Total Price of Contract: ________________________________________________(h)Total Fixed-Fee (if applicable): __________________________________________(i)

Invoicing Type: Three-Way Match(j)

Office of Acquisitions:_______________________________________

Contractor’s EIN: ________________________

Contractor’s CAGE: ______________________

Contractor’s DUNS: ______________________

DHHS/OS/ASPR/BARDA
ATTN: Contracting Officer
O’Neill House Office Building
Washington, DC 20515

Point of Contact Name, Title, Email, Phone:_______________________________________(k)Central Point of Distribution: N/A_____________________________________________________________________________________________________________________(l) This invoicing request represents reimbursable costs for the period from:

CLIN No.

Unit(m) Current Amount(n) Cumulative Amount(o) Total Contract Amount__________________________________________________________________________________________________________

Brief description of the work/deliverable(s) being invoiced:

I certify that all payments are for appropriate purposes and in accordance with the contract.

___________________________(Name of Official)____________________(Title)Note: Please attach supporting documents and details as specified in the contract to support the work/deliverable(s) being invoiced43