CSS with Attachments_75A50121R00033 (v2).pdf

COMBINED SYNOPSIS / SOLICITATION

75A50121R00033

TITLE: Rapid Screening of MCM Efficacy Against SARS-CoV-2 Pseudoviruses with Spike Variants

(i) This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

(ii) The solicitation number is 75A50121R00033 and the solicitation is issued as a request for proposal

(RFP). This acquisition is for a commercial services and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures, FAR Subpart 13.5—Simplified Procedures for Certain Commercial Items, and FAR Part 12—Acquisition of Commercial Items, FAR Subpart 18.202(d), and is expected to exceed the simplified acquisition threshold.

(iii) This is a competitive combined synopsis/solicitation. Award(s) will be made to the offerors whose proposal(s) successfully address each of the identified requirements, and for which the proposed price is determined to be fair, reasonable and realistic.

(iv) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2021-03, dated February 16, 2021.

(v) The associated NAICS code is 621511 and the Small Business size standard is $31.5M. This requirement is competitive and is not set aside exclusively for small businesses.

DESCRIPTION

(vi) The Biomedical Advanced Research and Development Authority (BARDA), Department of Health and Human Services (HHS) seeks to acquire laboratory assay testing capacity for evaluation of medical countermeasures for SARS-CoV-2 in a pseudovirus neutralization assay (PsVNA). The assay permits analysis of serum samples collected from human subjects (convalescent and/or vaccinated) as well as therapeutic monoclonal and polyclonal antibodies. Samples are to be tested to ascertain the ability to recognize and maintain neutralization versus both predominant circulating and emerging variants of SARS-CoV-2. The USG has supported development of a SARS-CoV-2 Spike pseudotyped VN assay. The current effort seeks to utilize a pseudotyped VN assay for rapid testing of emerging virus variants and expanded medical countermeasures (MCMs).

See attached Statement of Objectives for complete requirement details.

EVALUATION AND AWARD

(vii) The Government anticipates including a 2-year period of performance for the base effort. The

Government also anticipates including option quantities in any resultant contract.

See attached Statement of Objectives for complete breakdown of options.

(viii) The Government plans to award a contract resulting from this solicitation. The resulting award will be made to the responsible Offeror whose offer will be most advantageous to the Government, price and other factors considered. The factors listed below shall be used to evaluate proposals. Comparative evaluations will be conducted if multiple proposals are received.

(a) Technical Capability

(b) Price

(c) Past Performance

SUBMISSION INSTRUCTIONS

(ix) All responses to this RFP must be received by 3:00pm Eastern Time on Friday, May 7, 2021 and must reference the solicitation number cited above. Responses must be submitted via email to Jeffrey Schmidt at Jeffrey.Schmid2@hhs.gov

(x) This is an RFP. This request does not commit the Government to pay any costs incurred in the preparation of the submission of this proposal or to contract for supplies or service. Supplies are of domestic origin unless otherwise indicated by Offeror. Any representations and/or certifications attached to this RFP must be completed by the Offeror.

(xi) Responses to this RFP must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service. Responses must also include the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size.

(xii) Responses to this RFP must include separate technical and business volumes.

(xiii) The Technical Volume must include a detailed work plan indicating how each aspect of the objectives are to be accomplished. The technical volume should be in as much detail as you considered necessary to fully explain your proposed technical approach or method. In addition, the technical volume must include:

(a) Technical rationale, technical approach, and plan for accomplishment of goals and objectives within the timeframe allotted and in support of requirements and proposed deliverables.

Include in this section all proprietary claims to the results, property, intellectual property, or systems supporting and/or necessary for the effort in question. If there are no proprietary claims, this should be stated.

(b) A clearly defined organization chart for the program team which includes, as applicable: (1) the programmatic relationship of team member; (2) the unique capabilities of team members; (3) the task of responsibilities of team members; (4) the teaming strategy among the team members; and (5) the key personnel to be involved in the effort.

(c) Discussion concerning any potential likelihood to leverage the effort for use among other

Government organizations of interest if/as may be appropriate, along with any details concerning current use by other non-federal parties.

(d) Statement of Work (SOW) - In plain English, clearly define:

(1) The objective of the proposed contract.

(2) A detailed description of the proposed approach to accomplish the stated objective.

(3) The measurable milestones involved & associated completion criteria for each involved.

(4) All deliverables (reporting, data, reports, etc.) to be provided to the Government in support of the proposed tasks/activities.

(5) Description of the facilities to be used for the contracted effort, availability of the facility, and competition from other USG-funded activities.

(6) Capital and Commercial equipment to be purchased to achieve the contract objective.

(7) Estimated direct labor hours (including labor categories) to be performed to achieve the proposed objective.

(e) Past Performance Information – A list of the last three contracts completed during the past five years and all contracts currently being performed that are similar in nature to the solicitation work scope. Contracts listed may include those entered into by the Federal Government, agencies of state and local governments and commercial concerns. Include the following information for each contract listed: (1) Name of Contracting Organization; (2) Contract Number (for subcontracts, provide the prime contract number and the subcontract number); (3) Contract Type; (4) Total Contract Value; (5) Description of Requirement; (6) Contracting Officer's Name and Telephone Number; (7) Program Manager's Name and Telephone Number; and (8) North American Industry Classification System (NAICS) Code.

(xiv) The business volume shall contain enough information to allow the Government to perform a basic analysis of the propose cost or price of the work. The Government anticipates issuing a firm fixed price contract with payable milestones based on explicit milestone achievement criteria. The Cost Volume shall provide other than cost or pricing data in sufficient detail to substantiate the price proposed (e.g., realism and reasonableness). It is CRITICAL that the offeror’s cost proposal contain ALL prices and costs associated with each milestone. The proposal elements for each milestone must be supported by 3rd party vendor quotes, labor categories, labor hours, rates, applied fringe, overhead, G&A and profit. The breakdown shall include total proposed price, inclusive of all major cost items, as follows:

(a) Direct Labor – including individual labor categories with associated labor categories, labor hours and direct labor rates.

(b) Indirect Costs – Including Fringe Benefits, Overhead, General and Administrative (G&A) Expense, Cost of Money, Fee, etc. (must show base amount and rate).

(c) Subcontractors – List all subcontractors. For reach subcontractor, include total subcontract cost and build-out for all direct labor, indirect costs, travel, materials, and other direct costs.

(d) Travel – Provide the purpose of the trip, number of trips, number of days per trip, departure and arrival destinations, number of people, etc.

(e) Other Direct Costs (ODCs) – Itemized by cost category, with sufficient backup documentation to support proposed costs.

(f) Equipment Purchases – Itemized list with associated costs, including quantities, unit prices, proposed vendors (if known), and the basis of estimate (e.g., quotes, prior purchases, catalog price lists, etc.); any item that exceeds $10,000 must be supported with back-up documentation such as a copy of catalog price lists or quotes prior to purchase.

(g) Materials – Itemized list with associated costs, including quantities, unit prices, proposed vendors (if known), and the basis of estimate (e.g., quotes, prior purchases, catalog price lists, etc.); any item that exceeds $10,000 must be supported with back-up documentation such as a copy of catalog price lists or quotes prior to purchase.

(h) The source, nature, and amount of proposed costs to be billed to the Government.

(i) Any Forward Pricing Rate Agreement (FPRA), other rate agreements, other documentation concerning approved rates, or any other such documentation that may assist in expediting negotiations (if available).

(j) Proposers with a DCAA-approved cost accounting system must submit appropriate DCAA documentation that provides evidence of government approval of the cost accounting system.

COST INFORMATION SHALL BE PROVIDED IN MS EXCEL FORMAT WITH ACCESS TO ALL

CALULATIONS AND FORMULAS.

(xv) The Government anticipates requesting clarifying information after receipt and evaluation of your proposal.

(xvi) The Government reserves the right to enter into discussions.

(xvii) For information about this RFP, contact Jeffrey Schmidt, Contracting Officer, at 202- 205-0260 or Jeffrey.Schmidt2@hhs.gov.

TERMS AND CONDITIONS, PROVISIONS, AND REPRESENTATIONS

(xviii) The provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb 1998). This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The Offeror is cautioned that the listed provisions may include blocks that must be completed by the Offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the Offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at www.acquisition.gov.

The following provisions apply to this acquisition and are incorporated by reference:

(a) The provision at FAR 52.204-7, System for Award Management (Oct 2018).

(b) The provision at FAR 52.204-16, Commercial and Government Entity Code Reporting (Jul

2016).

(c) The provision at 52.204-26, Covered Telecommunications Equipment or Services-

Representation (Oct 2020).

(d) The provision at FAR 52.212-1, Instructions to Offerors – Commercial Items (Oct 2018).

(e) The provision at FAR 52.212-2 Evaluation—Commercial Items (Oct 2014).

(f) The provision at 52.212-3, Offeror Representations and Certifications—Commercial Items

(Dec 2019).

(xix) The clause at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998). This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full http://www.acquisition.gov/ text of a clause may be accessed electronically at www.acquisition.gov.

In addition to the clauses checked in FAR 52.212-5 (attached), the following clauses also apply to this acquisition and are incorporated by reference:

(a) The clause at FAR 52.204-13, System for Award Management Maintenance (Oct 2018).

(b) The clause at FAR 52.204-18, Commercial and Government Entity Code Maintenance (Jul

2016).

(c) The clause at FAR 52.204-23, Prohibition on Contracting for Hardware, Software, and

Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018).

(d) The clause at FAR 52.204-24, Representation Regarding Certain Telecommunications and

Video Surveillance Services or Equipment (Oct 2020).

(e) The clause at FAR 52.204-25, Prohibition on Contracting for Certain Telecommunications and

Video Surveillance Services or Equipment (Aug 2020).

(f) The clause at FAR 52.212-4, Contract Terms and Conditions – Commercial Items (Oct 2018).

(g) The clause at HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity

Investigations (December 18, 2015).

(xx) The following documents are attached:

(a) Statement of Objectives.

(b) The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders–Commercial Items (Mar 2020).

(c) Special Contracting Requirements.

(d) Security Requirements.

(xxi) HHS reserves the right to exercise priorities and allocations authority with respect to this contract, to include rating this order in accordance with 45 CFR Part 101, Subpart A—Health Resources Priorities and Allocations System.”

http://www.acquisition.gov/

RFP Number: 75A50121R00033 Attachment 1 – Statement of Objectives

Statement of Objectives (SOO)

Rapid Screening of MCM Efficacy Against SARS-CoV-2 Pseudoviruses with Spike Variants

I. Project Background

An outbreak of respiratory disease caused by a novel coronavirus was first detected in China in late 2019 and has now spread worldwide, including the United States (US). The virus has been named Severe Acute Respiratory Disease Coronavirus-2 (SARS-CoV-2) and causes Coronavirus Disease 2019 (COVID-19). On January 30, 2020, the International Health Regulations Emergency Committee of the World Health Organization (WHO), declared the outbreak a “Public Health Emergency of International Concern” (PHEIC). On January 31, 2020 the US Department of Health and Human Services (HHS) declared a Public Health Emergency for the US to aid the nation’s healthcare community in responding to COVID-19.

On March 11, 2020 WHO publicly declared COVID-19 as a pandemic. The US Government (USG) has since identified COVID-19 vaccine candidates and therapeutics that are progressing rapidly through advanced research and development and licensure. The Federal Response, a joint HHS and Department of Defense (DOD) leadership team, is charged with development of COVID-19 vaccines and other medical countermeasures (MCMs).

Viruses are constantly changing, and this includes SARS-CoV-2. A new virus variant has one or more mutations that differentiate it from the wild-type or predominant virus variants already circulating among the general population. As expected, multiple variants of SARS- CoV-2 have been documented in the United States and globally throughout this pandemic.

The U.S. government is monitoring the situation closely. The federal government is working with state public health, academic, and commercial laboratories to increase domestic genomic surveillance to improve our ability to detect emerging variants.

The genomic surveillance efforts support ongoing efforts to characterize SARS-CoV-2 variants to better understand how easily and quickly they may spread, whether they cause more severe disease, and whether currently authorized vaccines and therapeutics will protect people against them. These studies are essential to inform effective public health response. There is evidence to suggest that some of the mutations in the virus variants may affect the ability of antibodies (from manufactured, natural infection and/or vaccination) to recognize and neutralize the virus, but additional studies are needed.

This procurement action is aimed at providing laboratory assay testing capacity for evaluation of medical countermeasures for SARS-CoV-2 in a pseudovirus neutralization assay (PsVNA). The assay permits analysis of serum samples collected from human subjects (convalescent and/or vaccinated) as well as therapeutic monoclonal and polyclonal antibodies. Samples are to be tested to ascertain the ability to recognize and maintain neutralization versus both predominant circulating and emerging variants of SARS-CoV-2.

The USG has supported development of a SARS-CoV-2 Spike pseudotyped VN assay. The current effort seeks to utilize a pseudotyped VN assay for rapid testing of emerging virus variants and expanded medical countermeasures (MCMs).

II. Objectives

The program goals are to: (1) Provide supporting documentation of a validated PsVNA (VC;

lentivirus pseudotyped with SARS-CoV-2 spike protein D614G variant); (2) Produce SARS-CoV- 2 pseudotyped lentiviruses (pseudoviruses; PsVs) and evaluate infectivity; and (3) Test PsVs in combination with MCMs in the PsVNA . The Task Order will also include Optional Periods that may support evaluation of additional PsVs and MCMs; and preparation of manuscript(s) for the study.

III. Tasks

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, facilities, and a validated pseudotyped D614G VN assay for SARS-COV-2 not otherwise provided by the Government as needed to: (1) Provide supporting documentation of an established D614G PsVNA including regulatory status and assay performance using in-house standards (serum, D614G PsVs, etc); (2) produce SARS-CoV-2 pseudotyped lentiviruses and evaluate infectivity; and (3) test PsVs in combination with serum samples from human subjects, and MCMs using the PsVNA.

a. Base—CLIN 0001

The Base of this contract will consist of providing documentation of a validated PsVNA;

propagation of PsVs; and testing of up to 250 PsVs and 100 MCMs in the PsVNA.

In summary, the pseudotyped VN assay follows traditional protocols. The strategy for quantifying SARS-CoV-2 neutralizing antibodies utilizes lentivirus particles expressing SARS-CoV2 spike protein on their surface and containing a firefly (Luc) reporter gene for quantitative measurement of infection by relative luminescence units (RLU).

Infection takes place in transduced 293T cells expressing high levels of ACE2. Virus is applied to cells with or without pre-incubation with antibodies or human sera samples; neutralizing antibodies reduce infection, resulting in lower RLUs. Serial dilution of antibodies can be used to produce a dose-response curve to quantify potency. Neutralization is measured as 50% and 80% reduction in RLU. The pseudovirus used in the assay for evaluating neutralization is the 614G form of Wuhan-1 Spike. The assay is performed in 96-well flat-bottom clear Poly-L-Lysine treated culture plates for high throughput capacity. Luc signal is measured in 96-well flat bottom black/white plates for enhanced luciferase signal with minimal bleed-over. Use of a clonal cell line provides precision and uniformity.

Specific tasks to be completed by the Contractor included in the Base period:

i. Provide supporting documentation for an established SARS-CoV-2 spike pseudotyped VN assay and testing:

The Contractor will supply:

1. SOP for the PsVNA

2. A final validation report for the PsVNA

3. Critical reagents

4. Draft and Final Test plans

ii. Produce up to 250 PsVs and evaluate infectivity

iii. Test up to 250 PsVs in combination with up to 100 MCMs in the PsVNA

1. Supply USG results within 14 calendar days of plasmid receipt.

2. Qualification of up to 10 variants of concern (VOC).

iv. Prepare draft and final reports for PsVNA testing

b. Options—CLINs 0002-0027

Unless the Government exercises its option pursuant to the Option Clause set forth in Attachment 2—Special Contracting Requirements, the contract will consist only of the Contract Line Item Number (CLIN) 0001. Pursuant to that Option Clause, the Government may, by unilateral contract modification, require the Contractor to perform the additional options set forth below. If the Government exercises an option, written notice must be given at least 3 days prior to exercising the option, and the price of the contract will be increased as set forth in the contract.

The Government’s options consist of the following:

CLIN Option

Number Description

0002 Option 01 Sample testing of up to 250 pseudoviruses 0003 Option 02 Sample testing of up to 250 pseudoviruses 0004 Option 03 Sample testing of up to 250 pseudoviruses 0005 Option 04 Sample testing of up to 250 pseudoviruses 0006 Option 05 Sample testing of up to 250 pseudoviruses 0007 Option 06 Sample testing of up to 250 pseudoviruses 0008 Option 07 Sample testing of up to 250 pseudoviruses 0009 Option 08 Sample testing of up to 250 pseudoviruses 0010 Option 09 Sample testing of up to 250 pseudoviruses 0011 Option 10 Sample testing of up to 250 pseudoviruses 0012 Option 11 Sample testing of up to 250 pseudoviruses 0013 Option 12 Sample testing of up to 250 pseudoviruses 0014 Option 13 Sample testing of up to 250 pseudoviruses 0015 Option 14 Sample testing of up to 250 pseudoviruses 0016 Option 15 Sample testing of up to 250 pseudoviruses 0017 Option 16 Sample testing of up to 250 pseudoviruses 0018 Option 17 Sample testing of up to 250 pseudoviruses 0019 Option 18 Sample testing of up to 250 pseudoviruses 0020 Option 19 Sample testing of up to 250 pseudoviruses 0021 Option 20 Sample testing of up to 250 pseudoviruses 0022 Option 21 Sample testing of up to 250 pseudoviruses 0023 Option 22 Sample testing of up to 250 pseudoviruses

0024 Option 23 Sample testing of up to 250 pseudoviruses 0025 Option 24 Sample testing of up to 250 pseudoviruses 0026 Option 25 Sample testing of up to 250 pseudoviruses 0027 Option 26 Publication

c. Deliverables

The following General Deliverables are required:

Deliverable Description Due Date Daily check in with project staff for COVID-19 Contract

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

The updates will address key cost, schedule and technical updates. Daily updates may be shared with senior Government leaders during the COVID- 19 response and should be provided on a non-confidential basis, unless the update includes confidential information in which case Contractor shall provide the update in both confidential and non-confidential formats.

Daily check-ins may occur on weekdays, excluding federal holidays. Upon request of the Government, check-ins may also occur on weekends and on federal holidays, provided at least 24 hours’ notice.

No agenda will be required for the meeting

No meeting minutes are required

Contractor will provide bulleted email updates following any call or in lieu of a call by 2PM for that day

Teleconferences Prioritization of work for the next week.

Draft bulleted agenda provided 48 hours prior to teleconference.

Meeting minutes provided within 3 business days after teleconference.

Every week.

Communication Management Plan

Outlines communications goals and strategies for the contract; template will be provided.

With first monthly report.

Monthly Reports Reports must describe progress of meeting contract milestones, overall project assessment, problems encountered, and recommended solutions.

Reports must detail the planned progress and actual progress during the period covered, explaining occurrences of any differences and corrective steps/actions planned if behind schedule.

Reports must detail estimated and actual expenses, including a narrative of whether there is any discrepancy between % work completed and cumulative costs incurred to date, and invoice submissions/acceptance dates, and modifications.

Must include BARDA-provided templates

Reports must include an updated Gantt.

15th day of every month throughout the task order period of performance.

Draft Final Report At least 30 days prior to A final report shall be contract expiration.

provided for USG review and comment. The report shall summarize all work conducted during the period of performance and provide all results (include specific items required in the report).

Final Report The final report must address USG comments regarding the draft report.

On or before contract expiration.

Supplemental Technical Contractor shall provide Documents, Raw Data, Upon request and also as the Technical Documents Tabulation Data, or Data part of deliverables the upon request from the CO Analysis Contractor shall provide or COR raw data, Tabulation Data or Data Analysis or data report to BARDA.

Contractor Publication Timeline and USG Right to Publish Data

The Contractor and Government are committed to transparent and timely publication of data to ensure rapid distribution of information during the COVID-19 Pandemic.

Within 30 days of the primary analysis, results from clinical studies funded in whole or in part under this contract and consistent with Good Publications Practices. Sponsor must publish the primary endpoint analysis.

Within 90 days of the of study end date [last subject last visit] for studies funded in part or whole under this contract and consistent with Good Publication Practices sponsor shall publish data.

Contractor shall notify CO and within 30 of primary analysis results and study end date [last subject last visit] if they plan not to publish data.

Within 10 calendar days of a request for project data from the CO, the Contractor shall provide CO with requested data, information and materials in the form(s) requested by the government, to support the government publication of the data funded in part or whole under this contract

If the contractor does not elect to publish data, Contractor shall provide CO and COR with project data to support the government publication of data as deemed appropriate by the government, without the contractor involvement.

Press Releases Contractor agrees to accurately and factually represent the work conducted under this contract in all press releases

Contractor shall ensure that the CO has received and approved an advanced copy of any press release to this contract not less than 5 business days prior to the issuance of the press release.

If corrective action is required, the Contractor agrees to accurately and factually represent the work conducted under this contract in all press releases.

Any final press releases shall be submitted to BARDA no later than one

(1) calendar day prior to its Release.

The following Technical Deliverables and Milestones are required:

Deliverable Due Date

PsVNA SOP (Base) 30 days from award PsVNA validation report (Base) 30 days from award Acquire critical reagents (Base) 30 days from award Draft test plan (Base) 30 days from award Final test plan (Base) 30 days from receipt of BARDA comments PsVs production and infectivity testing; 250 (BASE)

120 days from signature of test plan for production of 250 PsVs; Upon request, capability to provide select PsVs within 2 weeks of plasmid delivery

PsVNA testing (BASE) 120 days after production of PsVs; Test and provide QC’d data for select PsVs within 2 weeks of plasmid delivery; Target delivery of data for minimum of 10 PsVs weekly as requested.

PsVNA Draft final report (BASE) 30 days after completion of PsVNA testing

PsVNA Final report (BASE) 30 days after receipt of comments from BARDA

Draft test plan (Option 1 - 25) 30 days from award of option

Final test plan (Option 1 - 25) 30 days from receipt of BARDA comments

PsVs production and infectivity testing; 250 (Option 1 - 25)

120 days from signature of test plan for production of 250 PsVs; Upon request, capability to provide select PsVs within 2 weeks of plasmid delivery

PsVNA testing (Option 1 - 25) 120 days after production of PsVs; Test and provide QC’d data for select PsVs within 2 weeks of plasmid delivery; Target delivery of data for minimum of 10 PsVs weekly as requested.

PsVNA Draft final report (Option 1 - 25)

30 days after completion of PsVNA testing

PsVNA Final report (Option 1 - 25) 30 days after receipt of comments from BARDA Publication (Option 26) 30 days after signature of final report

52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL

ITEMS ( )

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Aug 2020) (Section 889(a)(1)(A) of Pub. L. 115-232).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).

(5) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553).

(6) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and 108-78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1)

(2)

(3)

(4)

(5)

(6)

(7)

(8)

(9)

(10)

(11)

52.203-6

52.203-13

52.203-15

52.204-10

52.204-14

52.204-15

52.209-6

52.209-9

52.219-3

Restrictions on Subcontractor Sales to the Government (June 2020), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

Contractor Code of Business Ethics and Conduct (Jun 2020) (41 U.S.C. 3509)).

Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (June 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

Reporting Executive Compensation and First-Tier Subcontract Awards (Jun 2020) (Pub. L.

109-282) (31 U.S.C. 6101 note).

[Reserved].

Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub. L.

111-117, section 743 of Div. C).

Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Jun 2020) (31 U.S.C. 6101 note).

Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) (41 U.S.C.

2313).

[Reserved].

Notice of HUBZone Set-Aside or Sole-Source Award (Mar 2020) (15 U.S.C.657a).

(ii) Alternate I (Mar 2020) of 52.219-3.

(18)

(19)

(20)

(21)

(22)

(12)

(13)

(14)

(15)

(16)

(17)

(23)

(24)

(25)

(26)

52.219-4

52.219-6

52.219-7

52.219-8

52.219-9

52.219-13

52.219-14

52.219-16

52.219-27

52.219-28

52.219-29

52.219-30

52.219-32

52.219-33

(i), Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Mar 2020) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

(ii) Alternate I (Mar 2020) of 52.219-4.

[Reserved].

(i) Notice of Total Small Business Set-Aside (Nov 2020) of 52.219-6 (15 U.S.C. 644).

(ii) Alternate I (Mar 2020) of 52.219-6.

(i) 52.219-7, Notice of Partial Small Business Set-Aside (Nov 2020) (15 U.S.C. 644).

(ii) Alternate I (Mar 2020) of 52.219-7.

Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637(d)(2) and (3)).

(i), Small Business Subcontracting Plan (Jun 2020) (15 U.S.C. 637(d)(4)).

(ii) Alternate I (Nov 2016) of 52.219-9.

(iii) Alternate II (Nov 2016) of 52.219-9.

(iv) Alternate III (Jun 2020) of 52.219-9.

(v) Alternate IV (Jun 2018) of 52.219-9.

(i) Notice of Set-Aside of Orders (Mar 2020) (15 U.S.C. 644(r)).

Limitations on Subcontracting (Mar 2020) (15 U.S.C. 637(a)(14)).

Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Mar 2020) (15 U.S.C. 657 f).

Post Award Small Business Program Rerepresentation (Nov 2020) (15 U.S.C. 632(a)(2)). May require contractor completion.

(ii) Alternate I (Mar 2020) of 52.219-28.

Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Mar 2020) (15 U.S.C. 637(m)).

Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Mar 2020) (15 U.S.C. 637(m)).

Orders Issued Directly Under Small Business Reserves (Mar 2020) (15 U.S.C. 644(r)).

Nonmanufacturer Rule (Mar 2020)(15 U.S.C. 637(a)(17)).

(ii) Alternate I (Mar 2020) of 52.219-13.

(33)

(34)

(35)

✔ (36)

(37)

(27)

(28)

(29)

(30)

(31)

(32)

(38)

(39)

(40)

(41)

(42)

(43)

(44)

(45)

52.222-3

52.222-19

52.222-21

52.222-26

52.222-35

52.222-36

52.222-37

52.222-40

52.222-50

52.222-54

52.223-9

52.223-11

52.223-12

52.223-13

52.223-14

52.223-15

52.223-16

52.223-18

52.223-20

Convict Labor (June 2003) (E.O. 11755).

Child Labor—Cooperation with Authorities and Remedies (Jan 2020) (E.O. 13126).

Prohibition of Segregated Facilities (Apr 2015).

(i) Equal Opportunity (Sept 2016) (E.O. 11246).

(ii) Alternate I (Feb 1999) of 52.222-26. If this is checked, some terms have been waived.

(i) Equal Opportunity for Veterans (Jun 2020)(38 U.S.C. 4212).

(ii) Alternate I (July 2014) of 52.222-35. If this box is checked, some terms have been waived.

(i) Equal Opportunity for Workers with Disabilities (Jun 2020) (29 U.S.C. 793).

(ii) Alternate I (July 2014) of 52.222-36. If this box is checked, some terms have been waived.

Employment Reports on Veterans (Jun 2020) (38 U.S.C. 4212).

Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

(i) Combating Trafficking in Persons (Oct 2020) (22 U.S.C. chapter 78 and E.O. 13627).

(ii) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627). Alt I requires CO completion.

Employment Eligibility Verification (OCT 2015). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

(i) Estimate of Percentage of Recovered Material Content for EPA–Designated Items (May 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.) Requires CO completion.

(ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.) Alt I requires contractor certification.

Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (JUN 2016) (E.O. 13693). Requires contractor completion.

Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (JUN 2016) (E.O. 13693).

(i), Acquisition of EPEAT®-Registered Imaging Equipment (JUN 2014) (E.O.s 13423 and 13514).

(ii) Alternate I (Oct 2015) of 52.223-13.

(i) Acquisition of EPEAT®-Registered Televisions (JUN 2014) (E.O.s 13423 and 13514).

(ii) Alternate I (Jun 2014) of 52.223-14.

Energy Efficiency in Energy-Consuming Products (MAY 2020) (42 U.S.C. 8259b).

(i), Acquisition of EPEAT®-Registered Personal Computer Products (OCT 2015) (E.O.s 13423 and 13514).

(ii) Alternate I (Jun 2014) of 52.223-16.

Encouraging Contractor Policies to Ban Text Messaging While Driving (Jun 2020) (E.O. 13513).

Aerosols (JUN 2016) (E.O. 13693).

(46)

(47)

(48)

(49)

(50)

(51)

(52)

(53)

(54)

(57)

(58)

(59)

(59)

(61)

(61)

(63)

(63)

52.223-21

52.224-3

52.225-1

52.225-3

52.225-5

52.225-13

52.225-26

52.226-4

52.226-5

52.232-29

52.232-30

52.232-33

52.232-34

52.232-36

52.239-1

52.242-5

52.247-64

Foams (JUN 2016) (E.O. 13693).

(i), Privacy Training (JAN 2017) (5 U.S.C. 552a).

(ii) Alternate I (JAN 2017) of 52.224-3.

Buy American—Supplies (May 2014) (41 U.S.C. chapter 83).

(i), Buy American—Free Trade Agreements—Israeli Trade Act (May 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L.

103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.

(ii) Alternate I (May 2014) of 52.225-3.

(iii) Alternate II (May 2014) of 52.225-3.

(iv) Alternate III (May 2014) of 52.225-3.

Trade Agreements (Oct 2019) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

Restrictions on Certain Foreign Purchases (June 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150). Requires CO completion.

Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505, 10 U.S.C.

2307(f)).

Installment Payments for Commercial Items (Jan 2017) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

Payment by Electronic Funds Transfer—System for Award Management (Oct 2018) (31 U.S.C.

3332).

Payment by Electronic Funds Transfer—Other than System for Award Management (Jul 2013) (31 U.S.C. 3332). Requires CO completition.

Payment by Third Party (May 2014) (31 U.S.C. 3332).

Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

Payments to Small Business Subcontractors (JAN 2017)(15 U.S.C. 637(d)(13)).

(i), Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx.

1241(b) and 10 U.S.C. 2631).

(ii) Alternate I (Apr 2003) of 52.247-64.

(iii) Alternate II (FEB 2006) of 52.247-64.

Tax on Certain Foreign Procurements—Notice and Representation (Jun 2020)(55) 52.229-12

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[Contracting Officer check as appropriate.]

52.222-41 Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter 67). (1)

52.222-42 Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67). Requires CO completion.

(2)

52.222-43 Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple Year and Option Contracts) (Aug 2018) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

(3)

52.222-44 Fair Labor Standards Act and Service Contract Labor Standards—Price Adjustment (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

(4)

52.222-51 Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment—Requirements (May 2014) (41 U.S.C.

chapter 67).

(5)

52.222-53 Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services—Requirements (May 2014) (41 U.S.C. chapter 67).

(6)

52.222-55 Minimum Wages Under Executive Order 13658 (Nov 2020). (7)

52.222-62 Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706). (8)

52.226-6 Promoting Excess Food Donation to Nonprofit Organizations (Jun 2020) (42 U.S.C. 1792). (9)

(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, as defined in FAR 2.101, on the date of award of this contract, and does not contain the clause at 52.215-2, Audit and Records—Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e) (1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause-

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (Jun 2020) (41 U.S.C. 3509).

(ii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017)

(section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(iii) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) (Section 1634 of Pub. L. 115-91).

(iv) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Aug 2020) (Section 889(a)(1)(A) of Pub. L. 115-232).

(v) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C.637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds the applicable threshold specified in FAR 19.702(a) on the date of subcontract award, the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(vi) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

(vii) 52.222-26, Equal Opportunity (Sep 2015) (E.O.11246).

(viii) 52.222-35, Equal Opportunity for Veterans (Jun 2020) (38 U.S.C.4212).

(ix) 52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020) (29 U.S.C.793).

(x) 52.222-37, Employment Reports on Veterans (Jun 2020) (38 U.S.C.4212).

(xi) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

(xii) 52.222-41, Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter 67).

(xiii) (A) 52.222-50, Combating Trafficking in Persons (Oct 2020) (22 U.S.C. chapter 78 and E.O 13627).

(B) Alternate I (Mar 2015) of 52.222-50(22 U.S.C. chapter 78 and E.O 13627).

(xiv) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May 2014) (41 U.S.C. chapter 67).

(xv) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements (May 2014) (41 U.S.C. chapter 67).

(xvi) 52.222-54, Employment Eligibility Verification (Oct 2015) (E.O. 12989).

(xvii) 52.222-55, Minimum Wages Under Executive Order 13658 (Nov 2020).

(xviii) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2017) (E.O. 13706).

(xix) (A) 52.224-3, Privacy Training (Jan 2017) (5 U.S.C. 552a).

(B) Alternate I (Jan 2017) of 52.224-3.

(xx) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

(xxi) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (Jun 2020) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xxii) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx.1241

(b) and 10 U.S.C.2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

(2) While not required, the Contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.

(End of clause)

RFP Number: 75A50121R00033 Attachment 3 – Special Contracting Requirements

ATTACHMENT 3 – SPECIAL CONTRACT REQURIEMENTS

A. REPORTING MATTERS OF FRAUD, WASTE, AND ABUSE

Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in BARDA funded programs should report such matters to the DHHS Inspector General's Office in writing or on the Inspector General's Hotline. The toll free number is 1-800-HHS-TIPS (1-800- 447-8477). All telephone calls will be handled confidentially. The 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

B. PROHBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST ACTIVITIES

The 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.

C. IDENTIFICATION AND DISPOSTION OF DATA

The Contractor will be required to provide certain data generated under this Contract to DHHS.

DHHS reserves the right to review any other data related to performance of this Contract.

The Contractor shall keep copies of all data required by the FDA relevant to this Contract for the time specified by the FDA.

D. 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).

E. 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 commencement of any work, the Contractor agrees to notify the CO promptly that, to the best of its knowledge and belief, no actual or potential conflict of interest exists or to identify to the CO any actual or potential conflict of interest the firm 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 with the CO, to avoid, mitigate, or neutralize the actual or potential conflict of interest. The Contractor shall continue performance until notified by the CO of any contrary action to be taken. Remedies include termination of this Contract for convenience, in whole or in part, if the CO deems such termination necessary to avoid an organizational 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.

F. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

The Contractor shall not use contract funds to disseminate information that is deliberately false or misleading.

G. CONFIDENTIAILTIY OF INFORMATION

1. Confidential information, as used in this article, means information or data of a personal nature about an individual, or proprietary information or data submitted by or pertaining to an institution or organization.

2. The CO and the Contractor may, by mutual consent, identify elsewhere in this Contract specific information and/or categories of information which the Government will furnish to the Contractor or that the Contractor is expected to generate which is confidential and providing further that the Government is not entitled to unlimited rights to that information pursuant to FAR 52.227-14.