75N93019R00028_-_30_Oct_19.pdf

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SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority: FAR 1.602-1

2. Broad Agency Announcement (BAA) Number:

75N93019R00028

3. Issue Date:

October 30, 2019

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : Broad Agency Announcement - NIAID Centers of Excellence for Influenza Research and Response

6. ISSUED BY:

Office of Acquisitions National Institute of Allergy and Infectious Diseases National Institutes of Health 5601 Fishers Lane Rockville, MD 20852

7. SUBMIT OFFERS TO:

See Part III, Section J, "Packaging and Delivery of the Proposal," ATTACHMENT 1 of this Solicitation.

8. Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in Attachment 1, "Packaging and Delivery of the Proposal," until 3:00PM EST on March 02, 2020. Offers will be valid for 120 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043.

9. This solicitation requires delivery of proposals as stated in ATTACHMENT 1, "PACKAGING AND DELIVERY OF THE PROPOSAL." If proposals are required to be delivered to two different locations, the OFFICIAL POINT OF RECEIPT for determining TIMELY DELIVERY is the address provided for the OFFICE OF ACQUISITIONS.

IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR HIS DESIGNEE AT THE PLACE AND TIME SPECIFIED FOR THE OFFICE OF ACQUISITIONS, THEN IT WILL BE CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH subparagraph (c)(3) of FAR Clause 52.215-1, Instructions to Offerors, LOCATED IN SECTION L.1. OF THIS SOLICITATION.

10. Offeror must be registered in the System for Award Management (SAM) prior to award of a contract. Offerors must access the CCR through The System for Award Management (SAM) at http://www.sam.gov

11. FOR INFORMATION CALL: Daniel Bresnahan

PHONE: 301-761-7688

e-MAIL: daniel.bresnahan@nih.gov

No collect calls or facsimile transmissions will be accepted.

Deadline for Receipt of Questions: December 02, 2019 When submitting questions, the solicitation number must be included in the subject line.

Daniel Bresnahan Contracting Officer National Institute of Allergy and Infectious Diseases Office of Acquisitions http://www.sam.gov

BAA Number : 75N93019R00028

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BAA TABLE OF CONTENTS

PART I - THE SCHEDULE

SECTION A - SOLICITATION/CONTRACT FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

SECTION G - CONTRACT ADMINISTRATION DATA

SECTION H - SPECIAL CONTRACT REQUIREMENTS

PART II - CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

SOLICITATION ATTACHMENTS

TECHNICAL PROPOSAL ATTACHMENTS

BUSINESS PROPOSAL ATTACHMENTS

INFORMATIONAL ATTACHMENTS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

1. GENERAL INFORMATION

a. NAICS CODE AND SIZE STANDARD

b. TYPE OF CONTRACT AND NUMBER OF AWARDS

c. COMMITMENT OF PUBLIC FUNDS

d. PROMOTING EFFICIENT SPENDING

e. COMMUNICATIONS PRIOR TO CONTRACT AWARD

f. RELEASE OF INFORMATION

g. PREPARATION COSTS

h. SERVICE OF PROTEST

2. INSTRUCTIONS TO OFFERORS

a. GENERAL INSTRUCTIONS

1. Contract Type and General Clauses

2. Authorized Official and Submission of Proposal

3. Proposal Summary and Data Record (NIH-2043)

4. Separation of Technical and Business Proposals

5. Alternate Proposals

6. Evaluation of Proposals

7. Potential Award Without Discussions

8. Use of the Metric System of Measurement

9. Standards for Privacy of Individually Identifiable Health Information

10. Privacy Act - Treatment of Proposal Information

11. Selection of Offerors

12. Institutional Responsibility Regarding Investigator Conflicts of Interest

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13. ROTC Access and Federal Military Recruiting on Campus

14. Certification of Filing and Payment of Taxes

15. Prohibition on Contractor Involvement with Terrorist Activities

16. Electronic Information Technology Accessibility Notice, HHSAR 352.239-73 (December 2015)

17. Solicitation Provisions Incorporated by Reference

b. TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Human Subjects

5. Care of Live Vertebrate Animals

6. Research Involving Live Vertebrate Animals

7. Possession, Use and Transfer of Select Biological Agents or Toxins

8. Dual Use Research of Concern

9. Obtaining and Disseminating Biomedical Research Resources

c. BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Cost and Pricing Data

4. Requirements for Cost or Pricing Data or Information Other than Cost and Pricing Data

5. Salary Rate Limitation

6. Small Business Subcontracting Plan

7. Mentor Protege Program, HHSAR 352.219-70

8. HUBZone Small Business Concerns

9. Other Administrative Data

10. Qualifications of the Offeror

11. Subcontractors

12. Proposer's Annual Financial Report

13. Travel Costs/Travel Policy

14. Certification of Visas for Non-U.S. Citizens

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. HUMAN SUBJECT EVALUATION

4. LIVE VERTEBRATE ANIMALS EVALUATION

5. EVALUATION OF OPTIONS

6. EVALUATION OF DATA SHARING PLAN

7. EVALUATION OF PLAN FOR SHARING MODEL ORGANISMS FOR BIOMEDICAL RESEARCH

8. TECHNICAL EVALUATION FACTORS

9. EVALUATION OF ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY- SECTION

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PART I - THE SCHEDULE

THE INFORMATION SET FORTH IN SECTION A - SOLICITATION/CONTRACT FORM, HEREIN CONTAINS IMPORTANT INFORMATION FOR ANY OFFEROR INTERESTED IN RESPONDING TO THIS SOLICITATION.

ANY CONTRACT RESULTING FROM THIS SOLICITATION WILL INCLUDE IN ITS SECTION A - SOLICITATION/ CONTRACT FORM, ACCOUNTING, APPROPRIATION AND GENERAL INFORMATION APPLICABLE TO THE

CONTRACT AWARD.

THE CONTRACT SCHEDULE SET FORTH IN SECTIONS B THROUGH H, HEREIN, CONTAINS CONTRACTUAL INFORMATION PERTINENT TO THIS SOLICITATION. IT IS NOT AN EXACT REPRESENTATION OF THE CONTRACT DOCUMENT THAT WILL BE AWARDED AS A RESULT OF THIS SOLICITATION. THE CONTRACT COST OR PRICE AND OTHER CONTRACTUAL PROVISIONS PERTINENT TO THE OFFEROR (i.e., those relating to the organizational structure [e.g., Non-Profit, Commercial] and specific cost authorizations unique to the Offeror's proposal and requiring Contracting Officer Prior Approval) WILL BE DISCUSSED IN THE NEGOTIATION PROCESS AND WILL BE INCLUDED IN THE RESULTANT CONTRACT. THE ENCLOSED CONTRACT SCHEDULE IS

INTENDED TO PROVIDE THE OFFEROR WITH THE NECESSARY INFORMATION TO UNDERSTAND THE

TERMS AND CONDITIONS OF THE RESULTANT CONTRACT.

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The purpose of this solicitation is to establish the Centers of Excellence for Influenza Research and Response (hereinafter referred to as “CEIRR”) as an international and domestic basic and clinical influenza research program focused on the study of the natural history, transmission, and pathogenesis of influenza in humans and at interspecies interfaces, including the provision of critical infrastructure for emergency response.

ARTICLE B.2. ESTIMATED COST - OPTION

1. The estimated cost of the Base Period of this contract is $ .

2. If the Government exercises its option pursuant to the OPTION PROVISION Article in SECTION H of this contract, the Government's total estimated contract amount is as follows:

Estimated Cost Plus Fixed Fee

Base Period

Option Period(s):

Total

[Base Period and Option(s)]

ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS

This article will prohibit or restrict the use of contract funds, unless otherwise approved by the Contracting Officer. The following is a list of items that may be included in the resultant contract as applicable. 1) Conferences & Meetings, 2) Food for Meals, Light Refreshments & Beverages, 3) Promotional Items, 4) Acquisition, by purchase or lease, of any interest in real property; 5) Special rearrangement or alteration of facilities; 6) Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value; 7) Travel Costs including Foreign Travel; 8) Consultant Costs; 9) Subcontract Costs; 10) Patient Care Costs; 11) Accountable Government Property; 12) Printing costs; and 13) Research Funding.

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ARTICLE B.4. ADVANCE UNDERSTANDINGS

Specific elements of cost, which normally require prior written approval of the Contracting Officer before incurrence of the cost (e.g., foreign travel, consultant fees, subcontracts) will be included in this Article if the Contracting Officer has granted his/her approval prior to contract award.

See Attachment 8, "Advance Understandings," for more information.

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SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

a. Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, dated (to be proposed by contractor), attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format. In addition, one hardcopy of each report shall be submitted to the Contracting Officer.

All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at: http://www.hhs.gov/web/508/index.html under "Making Files Accessible."

All paper/hardcopy documents/reports submitted under this contract shall be printed or copied, double-sided, on at least 30 percent post consumer fiber paper, whenever practicable, in accordance with FAR 4.302(b).

a. Technical Progress Reports

1. In addition to the required reports set forth elsewhere in this Schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required in any contract resulting from this solicitation. These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined prior to contract award. [Note: Beginning May 25, 2008, the Contractor shall include the applicable PubMed Central or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research.]

For proposal preparation purposes only, it is estimated that in addition to the required electronic version(s) 1 hard copies of these reports will be required as follows:

[X] Bi-Monthly [ ] Quarterly [X] Semi-Annually [X] Annually [ ] Annually (with a requirement for a Draft Annual Report) [X] Final - Upon final completion of the contract [ ] Final - Upon final completion of the contract (with a requirement for a Draft Final Report)

2. Summary of Salient Results

The Contractor will be required to prepare and submit, with the final report, a summary (not to exceed 200 words) of salient results achieved during the performance of the contract. This report will be required on or before the expiration date of the contract.

3. Reporting on Dual Use Research of Concern http://www.hhs.gov/web/508/index.html

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a. Progress Report For work involving an agent or toxin identified in the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern or "DURC policy" (see http://www.phe.gov/s3/dualuse/Documents/durc-policy.pdf), the contractor shall report the following information in the Annual/Semi-Annual/Quarterly/Monthly Progress report:

i. Identification of agents or toxins that are listed in the DURC policy and used in research funded in this contract, and;

ii. Proposed modifications, if any, to the risk mitigation plan.

b. Special Notifications The contractor shall report to the Contracting Officer's Representative, within 30 calendar days of:

i. Any change in the status of the DURC project funded under this contract (including whether the research is determined by the contractor's institutional review entity to no longer meet the definition of DURC);

ii. Details of any changes to risk mitigation plans (such changes need to be pre-approved by the Contracting Officer's Representative), or;

iii. Instances of noncompliance with the DURC policy, as well as mitigation measures undertaken by the contractor to prevent recurrences of similar noncompliance.

4. Annual Technical Progress Report for Clinical Research Study Populations

The Contractor shall submit information about the inclusion of women and members of minority groups and their subpopulations (when appropriate) for each study being performed under this contract. The Contractor shall submit this information in the format indicated in the attachment entitled, "" PHS Human Subjects and Clinical Trials Information Form/ Cumulative Inclusion Enrollment Report," which is set forth in SECTION J of this contract. The Contractor also shall use this format, modified to indicate that it is a final report, for reporting purposes in the final report. If the clinical study(s) involves US and non-US sites, the US sites and non-US sites should be reported on separate Cumulative Inclusion Enrollment Reports.

The Contractor shall submit the report in accordance with the DELIVERIES Article in SECTION F of this contract.

In addition, the NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research, Amended, October, 2001 applies. If this contract is for Phase III clinical trials, see II.B of these guidelines. The Guidelines may be found at the following website: http://grants.nih.gov/ grants/funding/women_min/women_min.htm.

For NIH-defined Phase III Clinical Trials: Include a description of the plans for valid analysis in the study design and outcomes. This includes designing the study in a manner that potential differences, as appropriate, by sex/gender and/or racial/ethnic groups in the clinical trial protocol could be conducted. Also, provide a description of any analyses by sex/gender, race, and/or ethnicity, as appropriate, in the annual progress report and the final report. If the analysis reveals no subgroup differences, a brief statement to that effect, indicating the subgroups analyzed, will suffice. The Government strongly encourages inclusion of the results of subgroup analysis in all publication submissions. In the final report, the Contractor shall include all final analyses of the data on sex/ gender, race and/or ethnicity.

5. Reporting on Select Agents or Toxins and/or Highly Pathogenic Agents http://grants.nih.gov/grants/funding/women_min/women_min.htm http://grants.nih.gov/grants/funding/women_min/women_min.htm

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For work involving the possession, use, or transfer of a Select Agent or Toxin and/or a Highly Pathogenic Agent, the following information shall also be included in each Semi-AnnualProgress Report:

1. Any changes in the use of the Select Agent or Toxin including initiation of "restricted experiments," and/or a Highly Pathogenic Agent, that have resulted in a change in the required biocontainment level, and any resultant change in location, if applicable, as determined by the IBC or equivalent body or institutional biosafety official.

2. If work with a new or additional Select Agent or Toxin and/or a Highly Pathogenic Agent will be conducted in the upcoming reporting period, provide:

a. A list of each new or additional Select Agent or Toxin and/or a Highly Pathogenic Agent that will be studied;

b. A brief description of the work that will be done with each new or additional Select Agent or Toxin and/or a Highly Pathogenic Agent and whether or not the work is a Select Agent or Toxin restricted experiment as defined in the Select Agents Regulation 42 CFR Part 73, Section 13.b ( http://www.selectagents.gov/Regulations.html) or listed on the U.S. National Select Agents Registry restricted experiments website ( http://www.selectagents.gov/ index.html);

c. The name and location for each biocontainment resource/facility, including the name of the organization that operates the facility, and the biocontainment level at which the work will be conducted, with documentation of approval by your IBC or equivalent body or institutional biosafety official. It must be noted if the work is being done in a new location or different location.

d. For work with Select Agents performed in the U.S. provide documentation of registration status of all domestic organizations where Select Agent(s) will be used. For work with Select Agents performed in a non-U.S. country prior NIAID approval is required.

If the IBC or equivalent body or institutional biosafety official has determined, for example, by conducting a risk assessment, that the work that has been performed or is planned to be performed under this contract may be conducted at a biocontainment safety level that is lower than BSL3, a statement to that affect shall be included in each Semi-Annual Progress Report.

If no work involving a Select Agent or Toxin and/or a Highly Pathogenic Agent has been performed or is planned to be performed under this contract, a statement to that affect shall be included in each Semi-Annual Progress Report.

b. Other Reports/Deliverables

1. Reporting of Financial Conflict of Interest (FCOI)

All reports and documentation required by 45 CFR Part 94, Responsible Prospective Contractors including, but not limited to, the New FCOI Report, Annual FCOI Report, Revised FCOI Report, and the Mitigation Report, shall be submitted to the Contracting Officer in Electronic format. Thereafter, reports shall be due in accordance with the regulatory compliance requirements in 45 CFR Part 94.

45 CFR Part 94 is available at: http://www.ecfr.gov/cgi-bin/text-idx?

c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45.

See Part 94.5, Management and reporting of financial conflicts of interest for complete information on reporting requirements.

http://www.selectagents.gov/Regulations.html http://www.selectagents.gov/index.html http://www.selectagents.gov/index.html http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45 http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45

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(Reference subparagraph g. of the INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF INTEREST Article in SECTION H of this contract.)

2. Section 508 Annual Report

The contractor shall submit an annual Section 508 report in accordance with the schedule set forth by the Contracting Officer (CO)/Contracting Officer's Representative (COR). The Section 508 Report Template and Instructions for completing the report are available at: http://www.hhs.gov/web/508/ contracting/technology/vendors.html under "Vendor Information and Documents."

REPORTING REQUIREMENTS FOR USE WITH THE ELECTRONIC REPORT DELIVERABLE

SUBMISSION (eRDS) SITE

All reports required herein shall be submitted in electronic format. All electronic contract deliverables shall be submitted via the NIAID electronic Report Deliverable Submission (eRDS) Site, available at the following website:

https://erds.niaid.nih.gov/. All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at http://www.hhs.gov/web/508/index.html under "Making Files Accessible."

ARTICLE C.3. 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, shall be directed to the Division of Extramural Inventions and Technology Resources (DEITR), OPERA, OER, NIH, 6705 Rockledge Drive, Suite 310, MSC 7980, Bethesda, Maryland 20892-7980 (Telephone: 301-435-1986). In addition, one copy of an annual utilization report, and a copy of the final invention statement, shall be submitted to the Contracting Officer. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted to the Contracting Officer on the expiration date of the contract.

The annual utilization report shall be submitted in accordance with the DELIVERIES Article in SECTION F of this contract. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted on the expiration date of the contract. All reports shall be sent to the following address:

Daniel Bresnahan Contracting Officer National Institutes of Allergy and Infectious Diseases National Institutes of Health, DHHS Office of Acquisition 5601 Fishers Lane, Room 3B46 Rockville, Maryland 20852-

If no invention is disclosed or no activity has occurred on a previously disclosed invention during the applicable reporting period, a negative report shall be submitted to the Contracting Officer at the address listed above.

To assist contractors in complying with invention reporting requirements of the clause, the NIH has developed "Interagency Edison," an electronic invention reporting system. Use of Interagency Edison is required as it streamlines the reporting process and greatly reduces paperwork. Access to the system is through a secure interactive Web site to ensure that all information submitted is protected. Interagency Edison and information relating to the capabilities of the system can be obtained from the Web ( http://www.iedison.gov), or by contacting the Extramural Inventions and Technology Resources Branch, OPERA, NIH.

http://www.hhs.gov/web/508/contracting/technology/vendors.html http://www.hhs.gov/web/508/contracting/technology/vendors.html http://www.iedison.gov

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SECTION D - PACKAGING, MARKING AND SHIPPING

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. 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.

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SECTION E - INSPECTION AND ACCEPTANCE

a. The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided.

b. For the purpose of this SECTION, the Contracting Officer's Representative is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

Division of Microbiology and Infectious Diseases National Institute of Allergy and Infectious Diseases National Institutes of Heatlh Rockville, Maryland

Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative within 30 days of receipt.

d. This contract incorporates the following clause by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available.

FAR Clause 52.246-3, Inspection of Supplies - Cost-Reimbursement (May 2001).

FAR Clause 52.246-8, Inspection of Research and Development - Cost-Reimbursement (May 2001).

Alternate I (April 1984) is not applicable to this contract.

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SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

a. The period of performance of this contract shall be from through .

b. If the Government exercises its option(s) pursuant to the OPTION PROVISION Article in Section H of this contract, the period of performance will be increased as listed below:

Option Option Period

ARTICLE F.2. DELIVERIES

Satisfactory performance of the final contract shall be deemed to occur upon performance of the work described in the Statement of Work Article in SECTION C of this contract and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule:

1. The items specified below as described in the REPORTING REQUIREMENTS Article in SECTION C of this contract will be required to be delivered in accordance with and by the date(s) specified below:

Item Description Quantity Delivery Schedule (1) (2) (3)

2. The above items shall be addressed and delivered to:

Addressee Deliverable Item No Quantity

ARTICLE F.3. LEVEL OF EFFORT

a. During the period of performance of this contract, the Contractor shall provide direct labor Hours . The labor Hours Exclude vacation, holiday, and sick leave. These labor Hours Exclude subcontractor labor Hours .

It is estimated that the labor Hours are constituted as specified below and will be expended approximately as follows:

Labor [HOURS, MONTHS, YEARS]

Labor Category

Year 1 Year 2 Year 3 Year 4 Year 5 Year 6 Year 7

Professional Other Professional

Support Totals

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ARTICLE F.4. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY

1998)

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address: https://www.acquisition.gov/?q=browsefar.

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989)

Alternate I (April 1984) is applicable to this contract.

https://www.acquisition.gov/?q=browsefar

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SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1. CONTRACTING OFFICER'S REPRESENTATIVE (COR)

The following Contracting Officer's Representative (COR) will represent the Government for the purpose of this contract:

[To be specified prior to award]

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract; or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference in Section K of the contract

The Government may unilaterally change its COR designation.

ARTICLE G.2. KEY PERSONNEL, HHSAR 352.237-75 (December 2015)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty days notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

(End of Clause)

The following individual(s) is/are considered to be essential to the work being performed hereunder:

Name Title

[To be specified prior to award] [To be specified prior to award]

ARTICLE G.3. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT

FINANCIAL REPORT

a. Invoice Submission/Contract Financing Request and Contract Financial Reporting, NIH(RC)-4for NIH Cost- Reimbursement Type Contracts are attached and made part of this contract. The Contractor shall follow the

- 15 -attached instructions and submission procedures specified below to meet the requirements of a "proper invoice" pursuant to FAR Subpart 32.9, Prompt Payment.

1. Payment requests shall be submitted bi-monthly to the offices identified below. Do not submit supporting documentation (e.g., receipts, time sheets, vendor invoices, etc.) with your payment request unless specified elsewhere in the contract or requested by the Contracting Officer.

1. The original invoice shall be submitted to the following designated billing office:

National Institutes of Health Office of Financial Management Commercial Accounts 2115 East Jefferson Street, Room 4B-432, MSC 8500 Bethesda, MD 20892-8500

2. One copy of the invoice shall be submitted to the following approving official:

Daniel Bresnahan, Contracting Officer National Institute of Allergy and Infectious Diseases Office of Acquisitions 5601 Fishers Lane Room 3B46 Rockville, Maryland 20852

E-mail: daniel.bresnahan@nih.gov

The Contractor shall submit an electronic copy of the payment request to the approving official instead of a paper copy. The payment request shall be transmitted as an attachment via e-mail to the address listed above in one of the following formats: MSWord, MS Excel, or Adobe Portable Document Format (PDF). Only one payment request shall be submitted per e-mail and the subject line of the e-mail shall include the Contractor's name, contract number, and unique invoice number.

[Note: The original payment request must still be submitted in hard copy and mailed to the designated billing office to meet the requirements of a "proper invoice."]

Central Point of Distribution:

The Contractor shall submit an electronic copy of the payment request to the Central Point of Distribution mailbox. The payment request shall be transmitted as an attachment via e-mail to the address listed above in one of the following formats: MSWord, MS Excel, or Adobe Portable Document Format (PDF). Only one payment request shall be submitted per e-mail and the subject line of the e-mail shall include the Contractor's name, contract number, and unique invoice number.

[Note: The original payment request must still be submitted in hard copy and mailed to the designated billing office to meet the requirements of a "proper invoice."]

2. In addition to the requirements specified in FAR 32.905 for a proper invoice, the Contractor shall include the following information on the face page of all payment requests:

1. Name of the Office of Acquisitions. The Office of Acquisitions for this contract is NIAID .

2. Federal Taxpayer Identification Number (TIN). If the Contractor does not have a valid TIN, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract. [Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract

- 16 -modified to include the VIN number.] If the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer.

3. DUNS or DUNS+4 Number. The DUNS number must identify the Contractor's name and address exactly as stated in the contract and as registered in the Central Contractor Registration (CCR) database. If the Contractor does not have a valid DUNS number, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract. [Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer.

4. Invoice Matching Option. This contract requires a two-way match.

5. Unique Invoice Number. Each payment request must be identified by a unique invoice number, which can only be used one time regardless of the number of contracts or orders held by an organization.

6. The Contract Title is:

NIAID Centers of Excellence for Influenza Research and Response

b. Inquiries regarding payment of invoices shall be directed to the designated billing office, (301) 496-6452.

c. The Contractor shall include the following certification on every invoice for reimbursable costs incurred with Fiscal Year funds subject to HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of this contract.

For billing purposes, certified invoices are required for the billing period during which the applicable Fiscal Year funds were initially charged through the final billing period utilizing the applicable Fiscal Year funds:

"I hereby certify that the salaries charged in this invoice are in compliance with HHSAR Clause 352.231-70, Salary Rate Limitation in SECTION I of the above referenced contract."

ARTICLE G.4. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS

SUBCONTRACTORS, FAR 52.232-40 (December 2013)

a. Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.

b. The acceleration of payments under this clause does not provide any new rights under the prompt Payment Act.

c. Include the substance of this clause, include this paragraph c, in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items.

(End of Clause)

ARTICLE G.5. INDIRECT COST RATES

In accordance with Federal Acquisition Regulation (FAR) (48 CFR Chapter 1) Clause 52.216-7 (d)(2), Allowable Cost and Payment incorporated by reference in this contract in PART II, SECTION I, the cognizant Contracting Officer representative responsible for negotiating provisional and/or final indirect cost rates is identified as follows:

Director, Division of Financial Advisory Services Office of Acquisition Management and Policy

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National Institutes of Health

6011 EXECUTIVE BLVD, ROOM 549C, MSC-7663

BETHESDA MD 20892-7663

These rates are hereby incorporated without further action of the Contracting Officer.

ARTICLE G.6. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

1. Contractor Performance Evaluations

Interim and Final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart 42.15. The Final performance evaluation will be prepared at the time of completion of work. In addition to the Final evaluation, Interim evaluation(s) will be prepared as determined by the COR and CO, but at least once during the performance of the Contract.

Interim and Final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final.

Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

2. Electronic Access to Contractor Performance Evaluations

Contractors may access evaluations through a secure Web site for review and comment at the following address:

http://www.cpars.gov http://www.cpars.gov

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SECTION H - SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. PROTECTION OF HUMAN SUBJECTS, HHSAR 352.270-4(b) (December 2015)

a. The Contractor agrees that the rights and welfare of human subjects involved in research under this contract shall be protected in accordance with 45 CFR part 46 and with the Contractor's current Federal-wide Assurance (FWA) on file with the Office for Human Research Protections (OHRP), Department of Health and Human Services. The Contractor further agrees to provide certification at least annually that the Institutional Review Board has reviewed and approved the procedures, which involve human subjects in accordance with 45 CFR part 46 and the Assurance of Compliance.

b. The Contractor shall bear full responsibility for the performance of all work and services involving the use of human subjects under this contract and shall ensure that work is conducted in a proper manner and as safely as is feasible. The parties hereto agree that the Contractor retains the right to control and direct the performance of all work under this contract. Nothing in this contract shall create an agency or employee relationship between the Government and the Contractor, or any subcontractor, agent or employee of the Contractor, or any other person, organization, institution, or group of any kind whatsoever. The Contractor agrees that it has entered into this contract and will discharge its obligations, duties, and undertakings and the work pursuant thereto, whether requiring professional judgment or otherwise, as an independent Contractor without creating liability on the part of the Government for the acts of the Contractor or its employees.

c. Contractors involving other agencies or institutions in activities considered to be engaged in research involving human subjects must ensure that such other agencies or institutions obtain their own FWA if they are routinely engaged in research involving human subjects or ensure that such agencies or institutions are covered by the Contractors' FWA via designation as agents of the institution or via individual investigator agreements (see OHRP Website at: http://www.hhs.gov/ohrp/policy/guidanceonalternativetofwa.pdf).

d. If at any time during the performance of this contract the Contractor is not in compliance with any of the requirements and or standards stated in paragraphs (a) and (b) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. The Contracting Officer may communicate the notice of suspension by telephone with confirmation in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer's written notice of suspension, the Contracting Officer may, after consultation with OHRP, terminate this contract in whole or in part.

e. (End of clause)

ARTICLE H.2. REQUIRED EDUCATION IN THE PROTECTION OF HUMAN RESEARCH

PARTICIPANTS

NIH policy requires education on the protection of human subject participants for all investigators receiving NIH contract awards for research involving human subjects. For a complete description of the NIH Policy announcement on required education in the protection of human subject participants, the Contractor should access the NIH Guide for Grants and Contracts Announcement dated June 5, 2000 at the following website:

http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

The information below is a summary of the NIH Policy Announcement:

The Contractor shall maintain the following information: (1) a list of the names and titles of the principal investigator and any other individuals working under the contract who are responsible for the design and/or conduct of the research; (2) the title of the education program(s) in the protection of human subjects that has been completed for each named personnel and; (3) a one sentence description of the educational program(s) listed in (2) above. This http://www.hhs.gov/ohrp/policy/guidanceonalternativetofwa.pdf http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html

- 19 -requirement extends to investigators and all individuals responsible for the design and/or conduct of the research who are working as subcontractors or consultants under the contract.

Prior to any substitution of the Principal Investigator or any other individuals responsible for the design and/or conduct of the research under the contract, the Contractor shall provide the following written information to the Contracting Officer: the title of the education program and a one sentence description of the program that has been completed by the replacement.

ARTICLE H.3. DATA AND SAFETY MONITORING IN CLINICAL TRIALS

The Contractor is directed to the full text of the NIH Policy regarding Data and Safety Monitoring and Reporting of Adverse Events, which may be found at the following web sites:

http://grants.nih.gov/grants/guide/notice-files/not98-084.html http://grants.nih.gov/grants/guide/notice-files/not99-107.html http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html

The Contractor must comply with the NIH Policy cited in these NIH Announcements and any other data and safety monitoring requirements found elsewhere in this contract.

Data and Safety Monitoring shall be performed in accordance with the approved Data and Safety Monitoring Plan.

The Data and Safety Monitoring Board shall be established and approved prior to beginning the conduct of the clinical trial.

ARTICLE H.4. GOOD CLINICAL PRACTICE TRAINING FOR NIH AWARDEES INVOLVED IN

NIH-FUNDED CLINICAL TRIALS

All NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2). GCP training may be achieved through a class or course, academic training program, or certification from a recognized clinical research professional organization. GCP training should be refreshed at least every three years to remain current with regulations, standards and guidelines. The Contractor shall provide completion of training documentation to the Contracting Officer's Representative (COR).

Investigator: The individual responsible for the conduct of the clinical trial at a trial site. If a clinical trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator.

Clinical Trial Staff: Individuals, identified by the investigator, who are responsible for study coordination, data collection and data management. Clinical trial staff may also be called the research coordinator, study coordinator, research nurse, study nurse or sub-investigator.

ARTICLE H.5. CLINICAL TRIAL REGISTRATION AND RESULTS INFORMATION

SUBMISSION

The Contractor conducting clinical trials, funded wholly or partially through the NIH extramural and intramural programs, shall ensure that its NIH-funded clinical trials are registered at, and summary results information is submitted to, www.clinicaltrials.gov for public posting. See NIH Guide Notice NOT-OD-16-149 dated September 16, 2016.

All NIH-funded clinical trials shall be registered and results information submitted to www.clinicaltrials.gov regardless of study phase, type of intervention, or whether they are subject to the regulation 42 CFR Part 11. Clinical trials subject to the regulation are called "applicable clinical trials."

http://grants.nih.gov/grants/guide/notice-files/not98-084.html http://grants.nih.gov/grants/guide/notice-files/not99-107.html http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html http://www.clinicaltrials.gov

- 20 -

The Contractor must submit a plan with its proposal to meet the regulatory requirements of the dissemination of information of NIH-funded Clinical Trials. The Contractor and investigators are required to comply with all terms and conditions of award, including following their acceptable plan for the dissemination of NIH-funded clinical trial information.

The Contractor must register all NIH-funded clinical trials in www.clinicaltrials.gov not later than 21 calendar days after the enrollment of the first participant. Results information from those trials must be submitted not later than one year after the trial's primary completion date. Submission of results information can be delayed in certain circumstances for up to two additional years for trials of products regulated by the FDA that are unapproved, unlicensed, or uncleared or for trials of products for which approval, licensure, or clearance of a new use is being sought. The Contractor shall include the trial registration number (NCT number) in the Technical Progress Report covering the period in which registration occurred, and as a standalone notification to the Contracting Officer within ten (10) calendar days of the registration. Each NIH-funded clinical trial must have only one entry in ClinicalTrials.gov that contains its registration and results information The Contractor shall include a specific statement in all informed consent documents relating to posting of clinical trials information to www.clinicaltrials.gov. The responsibilities of the Contractor will fall within one of the following three categories:

1. If the NIH-funded clinical trial is an applicable clinical trial under the regulation and the Contractor is the responsible party, the Contractor will ensure that all regulatory requirements are met.

2. If the NIH-funded clinical trial is an applicable clinical trial under the regulation but the Contractor is not the responsible party, the Contractor will coordinate with the responsible party to ensure that all regulatory requirements are met.

3. If the NIH-funded clinical trial is not an applicable clinical trial under the regulation, the Contractor will be responsible for carrying out the tasks and meeting the timelines described in regulation. Such tasks include registering the clinical trial in ClinicalTrials.gov and submitting results information to ClinicalTrials.gov.

Failure to comply with the terms and conditions of the award may provide a basis for enforcement actions. Identifying clinical trial record as non-compliant in ClinicalTrials.gov may lead to termination, consistent with 45 CFR 75.371 and/ or other authorities, as appropriate. If the NIH-funded clinical trial is also an applicable clinical trial, non-compliance with the requirements specified in 42 USC 282(j) and 42 CFR Part 11 may also lead to the actions described in 42

CFR 11.66.

The Contracting Officer may take one or more of the following enforcement actions, if the Contractor fails to provide evidence of compliance within 30 days.

• Temporary withhold payments pending correction of the deficiency;

• Disallow all or part of the cost of the activity or action not in compliance;

• Wholly or partly suspend or terminate the contract award;

• Initiate suspension or debarment proceedings as authorized under 2 CFR part 180 and HHS awarding regulations at 2 CFR part 376;

• Withhold further awards for the project and program;

• Take other remedies that may be legally available.

ARTICLE H.6. CLINICAL TRIAL REGISTRATION AND RESULTS INFORMATION

SUBMISSION PLAN

The special terms and conditions in the Contract Award that include a clinical trial:

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1. The clinical trial(s) supported by this award is subject to the plan dated [DATE] submitted to NIH and the NIH policy on Dissemination of NIH-Funded Clinical Trial Information. The plan must state that the clinical trial(s) funded by this award will be registered in ClinicalTrials.gov not later than 21 calendar days after enrollment of the first participant. The plan also must state that primary summary results shall be reported in ClinicalTrials.gov, including adverse event information, not later than one year after the primary completion date of the trial. The reporting of summary results is required by this term of award.

2. This award is subject to reporting requirements with each submission of the annual report. Contractor shall agree to the following annual certification. By affirming this annual certification:

The Contractor hereby certifies that all investigators conducting NIH-funded clinical trials under the NIH contract number are in compliance with the Contractor's plan addressing compliance with the NIH policy on Dissemination of NIH-Funded Clinical Trial Information. Any clinical trial funded wholly or partially under this award has been registered in ClinicalTrials.gov or will be registered not later than 21 calendar days after enrollment of the first participant. Primary summary results have been submitted to ClinicalTrials.gov or will be submitted not later than one year after the primary completion date of the trial.

ARTICLE H.7. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING

HUMAN SUBJECTS

NIH-conducted and supported clinical research must conform to the NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research in accord with Public Health Service Act sec. 4928 U.S.C. sec 289a-2. The policy requires that women and members of minority groups and their subpopulations must be included in all NIH-conducted or supported clinical research projects involving human subjects, unless a clear and compelling rationale and justification establishes…