BARDA CSS and Attachments_75A50121R00037.pdf

COMBINED SYNOPSIS / SOLICITATION

75A50121R00037

TITLE: COVID-19 Laboratory IVD (Diagnostics, Molecular)

(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 75A50121R00037 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 325413 and the Small Business size standard is 1,250 employees. This requirement is competitive and is 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 fund the necessary activities and clinical evaluations so an organization can transition their over the counter COVID-19 diagnostic tests from EUA to 510(k) and CLIA waiver. Among other things, the diagnostic test should be easy to use and not require external readers.

See attached Statement of Objectives for complete requirement details.

EVALUATION AND AWARD

(vii) The Government anticipates including a 14 – 20-month period of performance.

(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 Thursday, May 13, 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 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 http://www.acquisition.gov/ http://www.acquisition.gov/

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.”

Contract Number: TBD Attachment 1 – Statement of Objectives

ATTACHMENT 1 – Statement of Objectives

A. BACKGROUND

In December 2019, a novel (new) coronavirus known as SARS-CoV-2 was detected in Wuhan, Hubei Province, People’s Republic of China, causing outbreaks of the coronavirus disease COVID- 19 that has now spread globally. The Secretary of HHS declared a public health emergency on January 31, 2020, under Section 319 of the Public Health Service Act (42 U.S.C. 247d), in response to COVID-19. On March 1, 2020, the President of the United States, pursuant sections 01 and 301 of the National Emergencies Act (52 U.S.C. 1601 et seq.) and consistent with Section 1135 of the Social Security Act, as amended (42 U.S.C. 1320b-5), proclaimed that the COVID-19 outbreak in the United States constitutes a national emergency.

Under the President’s Operation Warp Speed Mission, HHS is contributing to a public-private partnership to facilitate and accelerate the development, manufacture, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.

To further the development, manufacture, and distribution of COVID-19 diagnostics, BARDA’s Detection, Diagnostics, and Devices Division has supported and continues to support organizations through contracting to obtain an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA).

To ensure the COVID-19 diagnostics remain in the marketplace for the foreseeable future, BARDA is now seeking to support organizations through contracting to obtain full 510(k) clearance from the FDA.

B. OBJECTIVES

The objective of this project is to fund the necessary activities and clinical evaluations so an organization can transition their COVID-19 diagnostic tests from EUA to 510(k) and CLIA waiver and include over the counter (OTC) claim. The diagnostic test should be a single-use lateral flow immunoassay with an integrated swab (no need for external swabs), that is capable of detecting clinically relevant SARS-CoV-2 viruses and emerging variants (e.g., B1.1.7, B1.351, P1), easy to use, and does not require external readers or electricity.

C. SPECIFIC TASKS

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 accomplish the following tasks:

Task 1: The contractor shall revise the design input of their test as necessary, as well as those not achieved for the EUA product, to demonstrate acceptable design outputs. The contractor shall perform component development for design improvement, process verification, technology transfer and product validation for the next generation test.

Task 2: The contractor shall assess new chemistry and antibodies for detection of clinically relevant COVID-19 variants. The test shall not require specialized electronics or need for electricity.

Contract Number: TBD Attachment 1 – Statement of Objectives

Task 3: The contractor shall perform any necessary validation testing requirement for 510(k) clearance. If additional clinical validation data is requested by the FDA, the contractor shall design, initiate, and implement trials either with their existing clinical partners or engage new partners as needed. The contractor shall also perform all necessary systems engineering studies needed for their regulatory submission.

Task 4: Program Management Activities. The Contractor shall establish the capacity in compliance with FDA cGMP regulations, and Biosafety Level standards, if applicable. The Contractor shall be responsible for management of all activities, including but not limited to, subcontractors to meet the goals of the contract, including holding routine meetings with USG, and completion of meeting minutes. On a monthly basis, the Contractor shall provide a monthly report that includes capacity availability and utilization, as well as any issues that affect the operational availability of the reserved capacity.

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)

Contract Number: Attachment 3 – Special Contracting Requirements

ATTACHMENT 3 – SPECIAL CONTRACT REQURIEMENTS

A. ENGAGEMENT WITH THE U.S. FOOD AND DRUG ADMINISTRATION (FDA)

1. FDA Meetings

The Contractor shall forward the dates and times of any meeting with the FDA to BARDA and make arrangements for appropriate BARDA staff to attend the FDA meetings if requested by BARDA. BARDA may include up to a maximum of four people (COR, CO and up to 2 subject matter experts).

Contractor shall notify BARDA of upcoming FDA meetings within 24 hours of scheduling.

The Contractor shall forward initial Contractor and FDA-issued draft minutes and final minutes of any meeting with the FDA to the CO and COR within 5 business days of receipt. All documents shall be duly marked as either “Draft” or “Final.”

2. FDA Submissions & Correspondence

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

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

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

Final FDA submissions and all email correspondence with the FDA related to submissions shall be submitted to the CO and COR no later than 5 calendar days of their submission to, or email correspondence with, the FDA.

3. FDA Audits

In the event of an FDA inspection which occurs as a result of this contract and for the product, or for any other FDA inspection that has the reasonable potential to impact the performance of this contract, the Contractor shall provide the CO and COR with an exact copy (non-redacted) of the FDA Form 483 and the Establishment Inspection Report (EIR) within five (5) business days after the Contractors receipt of those documents. The Contractor shall provide the COR and CO with copies of the plan for addressing areas of non-conformance to FDA regulations for GLP, GMP, or GCP guidelines as identified in the audit report, status updates during the plans execution and a copy of all final responses to the FDA. The Contractor shall also provide redacted copies of any FDA audits received from subcontractors that occur as a result of this contract or for this product. To the extent feasible, the Contractor shall make arrangements for BARDA representative(s) to be present during the final debrief by the regulatory inspector.

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

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

Contractor shall notify CO and COR within 10 business days of a scheduled FDA audit or within 24 hours of an ad hoc site visit/audit if the FDA does not provide 10 business days’ advance notice.

Contractor shall provide copies of any FDA audit report received from subcontractors that occur as a result of this contract or for this product within 5 business days of receiving correspondence from the FDA, Subcontractor, or third party.

Within 15 business days of audit report, Contractor shall provide CO with a plan for addressing areas of nonconformance, if any are identified.

Final FDA submissions shall be submitted to the CO and COR.

4. Other FDA Correspondence

The Contractor shall document any material correspondence between Contractor and FDA as related to activities funded under this contract and submit to BARDA. All such documents shall be duly marked as either “Draft” or “Final.” Contractor shall provide such written summary of any FDA correspondence or engagement within 5 business days and submit to the CO and COR. The written summary shall include:

A tracking log of progress on regulatory submissions with the FDA, description of the submission, date of the submission, status of submission and next steps.

B. REPORTING MATTERS OF FRAUD, WASTE, AND ABUSE

Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in BARDA funded programs should report such matters to the DHHS Inspector General's Office 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

C. 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.

D. 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.

E. EXPORT CONTROL NOTIFICATION

Contractors are responsible for ensuring compliance with all export control laws and regulations that may be applicable to the export of and foreign access to their proposed technologies.

Contractors may consult with the Department of State with any questions regarding 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).

F. 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.

G. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

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

H. NEEDLE DISTRIBUTION

The Contractor shall not use contract funds to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug.

I. CONFIDENTIAILTIY OF INFORMATION

1. Confidential information, as used in this article, means information or data of a personal nature about an individual, or proprietary information or data submitted by 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. Similarly, the CO and the Contractor may, by mutual consent, identify such confidential information from time to time during the performance of the contract. Failure to agree will be settled pursuant to the "Disputes" clause.

3. If it is established elsewhere in this Contract that information to be utilized under this Contract, or a portion thereof, is subject to the Privacy Act, the Contractor will follow the rules and procedures of disclosure set forth in the Privacy Act of 1974, 5 U.S.C. 552a, and implementing regulations and policies, with respect to systems of records determined to be subject to the Privacy Act.

4. Confidential information, as defined in paragraph (a) of this article, shall not be disclosed without the prior written consent of the individual, institution, or organization.

5. Whenever the Contractor is uncertain with regard to the proper handling of material under the Contract, or if the material in question is subject to the Privacy Act or is confidential information subject to the provisions of this article, the Contractor should obtain a written determination from the CO prior to any release, disclosure, dissemination, or publication.

6. The provisions of paragraph (d) of this article shall not apply to conflicting or overlapping provisions in other Federal, State or local laws.

J. ACCESS TO DOCUMENTATION / DATA

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

K. ACKNOWLEDGEMENT OF FEDERAL FUDNING

Section 507 of P.L. 104-208 mandates that Contractors funded with Federal dollars, in whole or in part, acknowledge Federal funding when issuing statements, press releases, requests for proposals, bid solicitations and other documents. This requirement is in addition to the continuing requirement to provide an acknowledgment of support and disclaimer on any publication reporting the results of a contract funded activity.

Publication and Publicity

No information related to data obtained under this Contract shall be released or publicized without providing BARDA with at least thirty (30) days advanced notice and an opportunity to review the proposed release or publication.

In addition to the requirements set forth in this Contract, Section 507 of P.L. 104-208 mandates that Contractors funded with Federal dollars, in whole or in part, acknowledge Federal funding when issuing statements, press releases, requests for proposals, bid solicitations and other documents. Contractors are required to state:

1. The percentage and dollar amounts of the total program or project costs financed with Federal money and;

2. The percentage and dollar amount of the total costs financed by non-governmental sources. For purposes of this Contract "publication" is defined as an issue of printed material offered for distribution or any communication or oral presentation of information, including any manuscript or scientific meeting abstract. Any publication containing data generated under this Contract must be submitted for BARDA review no less than thirty (30) calendar days for manuscripts and fifteen (15) calendar days for abstracts before submission for public presentation or publication. Contract support shall be acknowledged in all such publications substantially as follows:

"This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. _______.”

Press Releases

Misrepresenting contract results or releasing information that is injurious to the integrity of BARDA may be construed as improper conduct. Press releases shall be considered to include the public release of information to any medium, excluding peer-reviewed scientific publications.

With the exception of ad-hoc press releases required by applicable law or regulations, the Contractor shall ensure that the COR has received an advance copy of any press release related to the contract not less than two (2) business days prior to the issuance of the press release.

The Contractor shall acknowledge the support of the Department of Health and Human Service, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, whenever publicizing the work under this contract in any media by including an acknowledgment substantially as follows:

"This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, Division of Research Innovation and Ventures under Contract No. _______.”

BARDA Use of Contractor Logo

Contractor hereby grants BARDA the right to use Contractor’s corporate logo (and other artwork as agreed to by the parties), for presentations, internal and external websites, and other reasonable promotional and reporting uses relating to the project during the period of performance of the Contract (or for a longer period, if agreed between the parties).

L. PRIVACY ACT APPLICABILITY

Notification is hereby given that the Contractor and its employees are subject to criminal penalties for violation of the Privacy Act to the same extent as employees of the Government.

The Contractor shall assure that each of its employees knows the prescribed rules of conduct and that each is aware that he or she can be subjected to criminal penalty for violation of the Act. A copy of 45 C.F.R. Part 5b, Privacy Act Regulations, may be obtained at https://www.gpo.gov/fdsys/granule/CFR-2007- title45-vol1/CFR-2007-title45-vol1-part5b.

The Contractor is responsible for monitoring contractor compliance with the Privacy Act.

The Contractor shall follow the Privacy Act guidance as contained in the Privacy Act System of Records number 09-25-0200.

M. LABORATORY LICENSE REQUIREMENTS

The Contractor shall comply with all applicable requirements of Section 353 of the Public Health Service Act (Clinical Laboratory Improvement Act as amended) (42 U.S.C. 263a) and 42 CFR Part

493. This requirement shall also be included in any subcontract for services under the Contract.

N. QUALITY ASSURANCE (QA) AUDIT REPORTS

BARDA reserves the right to participate in QA audits as related to activities funded under this Contract. Upon completion of the audit/site visit the Contractor shall provide a report capturing the findings, results and next steps in…