A19_Combined SynSol_Post_Final.docx

SUBJECT: Pre- and Post- Influenza Human Sera Panels

SOLICITATION NUMBER: 75D30124Q77727

ISSUANCE DATE: July 17, 2024

QUESTIONS DUE DATE/TIME: July 24, 2024 by 5:00 PM EDT

RESPONSE DUE DATE/TIME: August 7, 2024 by 5:00 PM EDT

SECTION A – DESCRIPTION

This is a combined synopsis/solicitation for commercial items 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.

The solicitation number for this requirement is 75D30124Q77727 and is hereby issued as a Request for Quote (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2024-05 dated May 22, 2024.

The associated North American Industrial Classification System (NAICS) code for this procurement is 621511 – Medical Laboratories with a Standard Size of $41.5M.

This is a RFQ for the procurement of Pre and Post Influenza Human Sera Panels for the CDC demonstration project. The Government intends to award a Firm-Fixed Price (FFP) contract as a result of this solicitation that will include the terms and conditions that are set forth herein.

The provision at 52.212-1, Instructions to Offerors-Commercial, applies to this acquisition along with the addenda to the provision included in the solicitation document. FAR 52.212-2, Evaluation-Commercial Items, is included, and the specific evaluation criteria are included in paragraph (a) of that provision.

Offerors shall include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications-Commercial Items, with its offer or indicate if it is available online at SAM.gov. FAR 52.212-4, Contract Terms and Conditions-Commercial Items, applies to this acquisition; there are no addenda to the clause. FAR 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders-Commercial Items, applies to this acquisition and the additional FAR clauses cited in the clause that are applicable have been noted.

75D30124Q77727 Pre and Post Influenza Human Sera Panels There are no additional contract requirement(s) or terms and conditions determined by the contracting officer to be necessary for this acquisition and consistent with customary commercial practices. No telephonic proposals will be processed. All responses must be received no later than the date stated above. Contact Jennifer Gartzke, Contract Specialist, at xuy7@cdc.gov for any questions regarding this solicitation.

SECTION B – SUPPLIES OR SERVICES AND PRICES

Base Period (August 19, 2024 – August 18, 2025):

POP: 8/19/2024 – 8/18/2025

Payment terms:

POP: 8/19/2025 – 8/18/2026 Option Period 1

Payment terms:

POP: 8/19/2026 – 8/18/2027 Option Period 2

Payment terms:

POP: 8/19/2027 – 8/18/2028 Option Period 3

Payment terms:

POP: 8/19/2028 – 8/18/2029 Option Period 4

Payment terms:

Total Contract Value (Including Options): $____________

B.1 Purpose The purpose of this contract is for the provision of anonymous serum samples from six age cohorts (young pediatric, older pediatric, adolescents, adult, older adults, and elderly) with each individual providing blood prior to administration of the specified current, seasonal influenza vaccine (S1) and again 21 to 28 days after immunization (S2). For young pediatric populations (ages 6 months to 35 months) and older pediatrics who require two doses of influenza vaccines, the S2 blood will be collected 21 to 28 days after the second dose of influenza vaccine. Serum samples will be tested for vaccine-induced antibodies to determine if the current influenza vaccine strains induce protective levels of antibodies against newly circulating influenza virus strains.

This contract is also for the provision of large volume S2 samples from some of the adult participants for use in hemagglutination inhibition assays with virus isolates and characterization of immune responses following influenza vaccination.

B.2 Contract Type and Supplies This is a competitive procurement providing for full and open competition.

This acquisition is being competed in accordance with FAR Parts 12 and 13. The NAICS Code is 621511 – Laboratory Testing with a Small Business Standard Size of $41.5M. This is a firm fixed price contract to provide the required samples.

B.3 Travel Travel is not anticipated under this contract. However, if it were to become a requirement, approved, allowable, and allocable travel costs associated with the performance of task orders under the contract will be reimbursed. Contractor costs incurred for travel will be considered reasonable and allowable only to the extent they do not exceed, on a daily basis, the maximum per diem rates in effect at the time of travel as set forth in the Federal Travel Regulations (FTR) prescribed by the General Services Administration. As such, estimated allowable and allocable travel costs shall be included in the task order pricing when travel is anticipated. Costs incurred for transportation and per diem (lodging, meals, and incidental expenses) will be billed in accordance with the regulatory implementation of Public Law 99-234, FAR 31.205-46 Travel Costs. These costs are directly reimbursable. The Government shall not be charged general and administrative (G&A) fees for any travel. Contractor shall be reimbursed only for incurred costs at or below any “not to exceed” amount specified on the task order. Costs for transportation, lodging, meals, and incidental expenses incurred by Contractor personnel on official company business are allowable subject to the limitations contained in FAR 31.205-46 Travel Costs. No conference travel is allowed under this contract.

B.4 Place of Work and Government-Furnished Equipment Work under this contract will be performed off-site.

SECTION C - CONTRACT CLAUSES

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 this/these address(es):

https://www.acquisition.gov/browse/index/far http://www.hhs.gov/policies/hhsar/subpart301-1.html

(End of Clause)

52.202-1 Definitions (JUN 2020) 52.203-3 Gratuities. (APR 1984) 52.203-5 Covenant Against Contingent Fees (MAY 2014) 52.203-7 Anti-Kickback Procedures (JUN 2020) 52.203-12 Limitation on Payments to Influence Certain Federal Transactions. (JUN 2020) 52.204-13 System for Award Management Maintenance. (OCT 2018) 52.204-16 Commercial and Government Entity Code Reporting (AUG 2020) 52.204-17 Ownership or Control of Offeror (AUG 2020) 52.204-18 Commercial and Government Entity Code Maintenance. (AUG 2020) 52.204-19 Incorporation by Reference of Representations and Certifications. (DEC 2014) 52.204-20 Predecessor of Offeror (AUG 2020) 52.204-21 Basic Safeguarding of Covered Contractor Information Systems. (NOV 2021) 52.212-4 Contract Terms and Conditions – Commercial Products and Commercial Services (NOV 2023) 52.229-1 State and Local Taxes (APR 1984) 52.229-3 Federal, State, and Local Taxes (FEB 2013) 52.232-1 Payments (APR 1984) 52.232-39 Unenforceability of Unauthorized Obligations (JUN 2013) 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (MAR 2023) 52.233-1 Disputes (MAY 2014) 52.233-3 Protest After Award (AUG 1996) 52.233-4 Applicable Law for Breach of Contract Claim (OCT 2004) 52.237-3 Continuity of Services (JAN 1991) 52.242-13 Bankruptcy. (JUL 1995) 52.242-15 Stop-Work Order. (AUG 1989) 52.242-17 Government Delay of Work. (APR 1984) 52.244-6 Subcontracts for Commercial Products and Commercial Services (FEB 2024) 52.245-1 Government Property (SEP 2021)

HHSAR CLAUSES INCORPORATED BY REFERENCE

352.215.70 Late Proposals and Revisions (DEC 2015)

352.233-71 Litigation and Claims. (DEC 2015) 352.270-4b Protection of Human Subjects (DEC 2015) 352.270-12 Needle Exchange (DEC 2015) 352.270-13 Continued Ban on Funding Abortion and Continued Ban on Funding of Human Embryo Research (DEC 2015)

FAR CLAUSES INCORPORATED IN FULL TEXT

52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial Products and Commercial Services. (MAY 2024)

(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 products and commercial services:

(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 Covered Entities (Dec 2023) (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Nov 2021) (Section 889(a)(1)(A) of Pub. L. 115-232).

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

(5) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Mar 2023) ( 31 U.S.C. 3903 and 10 U.S.C. 3801).

(6) 52.233-3, Protest After Award (Aug 1996) ( 31 U.S.C. 3553).

(7) 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 products and commercial services:

[Contracting Officer check as appropriate.] _X_ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Jun 2020), with Alternate I (Nov 2021) ( 41 U.S.C. 4704 and 10 U.S.C. 4655).

_X_ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Nov 2021) ( 41 U.S.C. 3509)).

__ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (Jun 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

_X_ (4) 52.203-17, Contractor Employee Whistleblower Rights (Nov 2023) ( 41 U.S.C. 4712); this clause does not apply to contracts of DoD, NASA, the Coast Guard, or applicable elements of the intelligence community—see FAR 3.900(a).

_X_ (5) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jun 2020) (Pub. L. 109-282) ( 31 U.S.C. 6101 note).

__ (6) [Reserved].

__ (7) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

__ (8) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

_X_ (9) 52.204-27, Prohibition on a ByteDance Covered Application (Jun 2023) (Section 102 of Division R of Pub. L. 117-328).

__ (10) 52.204-28, Federal Acquisition Supply Chain Security Act Orders—Federal Supply Schedules, Governmentwide Acquisition Contracts, and Multi-Agency Contracts. (Dec 2023) ( Pub. L. 115–390, title II).

_X_ (11) (i) 52.204-30, Federal Acquisition Supply Chain Security Act Orders—Prohibition. (Dec 2023) ( Pub. L. 115–390, title II).

__ (ii) Alternate I (Dec 2023) of 52.204-30.

_X_ (12) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Nov 2021) ( 31 U.S.C. 6101 note).

__ (13) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) ( 41 U.S.C. 2313).

__ (14) [Reserved].

__ (15) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Oct 2022) ( 15 U.S.C. 657a).

__ (16) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Oct 2022) (if the offeror elects to waive the preference, it shall so indicate in its offer) ( 15 U.S.C. 657a).

__ (17) [Reserved] __ (18)(i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2020) ( 15 U.S.C. 644).

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

__ (19) (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.

_X_ (20) 52.219-8, Utilization of Small Business Concerns (Feb 2024) ( 15 U.S.C. 637(d)(2) and (3)).

_X_ (21) (i) 52.219-9, Small Business Subcontracting Plan (Sep 2023) ( 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 (Sep 2023) of 52.219-9.

__ (22) (i) 52.219-13, Notice of Set-Aside of Orders (Mar 2020) ( 15 U.S.C. 644(r)).

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

__ (23) 52.219-14, Limitations on Subcontracting (Oct 2022) ( 15 U.S.C. 637s).

_X_ (24) 52.219-16, Liquidated Damages—Subcontracting Plan (Sep 2021) ( 15 U.S.C. 637(d)(4)(F)(i)).

__ (25) 52.219-27, Notice of Set-Aside for, or Sole-Source Award to, Service-Disabled Veteran-Owned Small Business (SDVOSB) Concerns Eligible Under the SDVOSB Program (Feb 2024) ( 15 U.S.C. 657f).

_X_ (26) (i) 52.219-28, Post Award Small Business Program Rerepresentation (Feb 2024) ( 15 U.S.C. 632(a)(2)).

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

__ (27) 52.219-29, Notice of Set-Aside for, or Sole-Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Oct 2022) ( 15 U.S.C. 637(m)).

__ (28) 52.219-30, Notice of Set-Aside for, or Sole-Source Award to, Women-Owned Small Business Concerns Eligible Under the Women-Owned Small Business Program (Oct 2022) ( 15 U.S.C. 637(m)).

__ (29) 52.219-32, Orders Issued Directly Under Small Business Reserves (Mar 2020) ( 15 U.S.C. 644(r)).

__ (30) 52.219-33, Nonmanufacturer Rule (Sep 2021) ( 15U.S.C. 637(a)(17)).

_X_ (31) 52.222-3, Convict Labor (Jun 2003) (E.O.11755).

_X_ (32) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Feb 2024).

_X_ (33) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

_X_ (34) (i) 52.222-26, Equal Opportunity (Sep 2016) (E.O.11246).

__ (ii) Alternate I (Feb 1999) of 52.222-26.

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

__ (ii) Alternate I (Jul 2014) of 52.222-35.

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

__ (ii) Alternate I (Jul 2014) of 52.222-36.

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

_X_ (38) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

_X_ (39) (i) 52.222-50, Combating Trafficking in Persons (Nov 2021) ( 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).

_X_ (40) 52.222-54, Employment Eligibility Verification (May 2022) (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial products or commercial services as prescribed in FAR 22.1803.)

__ (41) (i) 52.223-9, 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.)

__ (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.)

__ (42) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (May 2024) ( 42 U.S.C. 7671, et seq.).

__ (43) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (May 2024) ( 42 U.S.C. 7671, et seq.).

__ (44) 52.223-20, Aerosols (May 2024) ( 42 U.S.C. 7671, et seq.).

__ (45) 52.223-21, Foams (May 2024) ( 42 U.S.C. 7671, et seq.).

__ (46) 52.223-23, Sustainable Products and Services (May 2024) ( E.O. 14057, 7 U.S.C. 8102, 42 U.S.C. 6962, 42 U.S.C. 8259b, and 42 U.S.C. 7671l).

_X_ (47) (i) 52.224-3 Privacy Training (Jan 2017) (5 U.S.C. 552 a).

__ (ii) Alternate I (Jan 2017) of 52.224-3.

__ (48) (i) 52.225-1, Buy American-Supplies (Oct 2022) ( 41 U.S.C. chapter 83).

__ (ii) Alternate I (Oct 2022) of 52.225-1.

__ (49) (i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (NOV 2023) ( 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, 19 U.S.C. chapter 29 (sections 4501-4732), Public Law 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 [Reserved].

__ (iii) Alternate II (Dec 2022) of 52.225-3.

__ (iv) Alternate III (Feb 2024) of 52.225-3.

__ (v) Alternate IV (Oct 2022) of 52.225-3.

__ (50) 52.225-5, Trade Agreements (NOV 2023) ( 19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

__ (51) 52.225-13, Restrictions on Certain Foreign Purchases (Feb 2021) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

__ (52) 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. Subtitle A, Part V, Subpart G Note).

__ (53) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) ( 42 U.S.C. 5150).

__ (54) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) ( 42 U.S.C. 5150).

_X_ (55) 52.226-8, Encouraging Contractor Policies to Ban Text Messaging While Driving (May 2024) ( E.O. 13513).

__ (56) 52.229-12, Tax on Certain Foreign Procurements (Feb 2021).

__ (57) 52.232-29, Terms for Financing of Purchases of Commercial Products and Commercial Services (Nov 2021) ( 41 U.S.C. 4505, 10 U.S.C. 3805).

__ (58) 52.232-30, Installment Payments for Commercial Products and Commercial Services (Nov 2021) ( 41 U.S.C. 4505, 10 U.S.C. 3805).

_X_ (59) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct2018) ( 31 U.S.C. 3332).

__ (60) 52.232-34, Payment by Electronic Funds Transfer-Other than System for Award Management (Jul 2013) ( 31 U.S.C. 3332).

__ (61) 52.232-36, Payment by Third Party (May 2014) ( 31 U.S.C. 3332).

__ (62) 52.239-1, Privacy or Security Safeguards (Aug 1996) ( 5 U.S.C. 552a).

_X_ (63) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) ( 15 U.S.C. 637(d)(13)).

__ (64) (i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Nov 2021) ( 46 U.S.C. 55305 and 10 U.S.C. 2631).

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

__ (iii) Alternate II (Nov 2021) of 52.247-64.

(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 products and commercial services:

[Contracting Officer check as appropriate.] __ (1) 52.222-41, Service Contract Labor Standards (Aug 2018) ( 41 U.S.C. chapter67).

__ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) ( 29 U.S.C. 206 and 41 U.S.C. chapter 67).

__ (3) 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).

__ (4) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (May 2014) ( 29U.S.C.206 and 41 U.S.C. chapter 67).

__ (5) 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).

_X _ (6) 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).

__ (7) 52.222-55, Minimum Wages for Contractor Workers Under Executive Order 14026 (Jan 2022).

__ (8) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2022) (E.O. 13706).

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

(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 products or commercial services. 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 (Nov 2021) ( 41 U.S.C. 3509).

(ii) 52.203-17, Contractor Employee Whistleblower Rights (Nov 2023) ( 41 U.S.C. 4712).

(iii) 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)).

(iv) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab Covered Entities (Dec 2023) (Section 1634 of Pub. L. 115-91).

(v) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (Nov 2021) (Section 889(a)(1)(A) of Pub. L. 115-232).

(vi) 52.204-27, Prohibition on a ByteDance Covered Application (Jun 2023) (Section 102 of Division R of Pub. L. 117-328).

(vii)

(A) 52.204–30, Federal Acquisition Supply Chain Security Act Orders—Prohibition. (Dec 2023) ( Pub. L. 115–390, title II).

(B) Alternate I (Dec 2023) of 52.204–30.

(viii) 52.219-8, Utilization of Small Business Concerns (Feb 2024) ( 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.

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

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

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

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

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

(xiv) 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.

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

(xvi)

(A) 52.222-50, Combating Trafficking in Persons (Nov 2021) ( 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).

(xvii) 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).

(xviii) 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).

(xix) 52.222-54, Employment Eligibility Verification (May 2022) (E.O. 12989).

(xx) 52.222-55, Minimum Wages for Contractor Workers Under Executive Order 14026 (Jan 2022).

(xxi) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2022) (E.O. 13706).

(xxii)

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

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

(xxiii) 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. Subtitle A, Part V, Subpart G Note).

(xxiv) 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.

(xxv) 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Mar 2023) ( 31 U.S.C. 3903 and 10 U.S.C. 3801). Flow down required in accordance with paragraph (c) of 52.232-40.

(xxvi) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Nov 2021) ( 46 U.S.C. 55305 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 products and commercial services a minimal number of additional clauses necessary to satisfy its contractual obligations.

(End of clause)

52.217-9 Option to Extend the Term of the Contract. (MAR 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within _15 days__; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least __30___ days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed __five years and zero months__.

(End of clause)

HHSAR CLAUSES INCORPORATED BY FULL TEXT

352.203-70 Anti-Lobbying. (DEC 2015)

Pursuant to the HHS annual appropriations acts, except for normal and recognized executive-legislative relationships, the Contractor shall not use any HHS contract funds for:

(a) Publicity or propaganda purposes;

(b) The preparation, distribution, or use of any kit, pamphlet, booklet, publication, electronic communication, radio, television, or video presentation designed to support or defeat the enactment of legislation before the Congress or any State or local legislature or legislative body, except in presentation to the Congress or any state or local legislature itself; or designed to support or defeat any proposed or pending regulation, administrative action, or order issued by the executive branch of any state or local government, except in presentation to the executive branch of any state or local government itself; or € Payment of salary or expenses of the Contractor, or any agent acting for the Contractor, related to any activity designed to influence the enactment of legislation, appropriations, regulation, administrative action, or Executive order proposed or pending before the Congress or any state government, state legislature or local legislature or legislative body, other than for normal and recognized executive-legislative relationships or participation by an agency or officer of a state, local, or tribal government in policymaking and administrative processes within the executive branch of that government.

(d) The prohibitions in subsections (a), (b), and (c) above shall include any activity to advocate or promote any proposed, pending, or future federal, state, or local tax increase, or any proposed, pending, or future requirement for, or restriction on, any legal consumer product, including its sale or marketing, including, but not limited to, the advocacy or promotion of gun control.

(End of clause)

352.208-70 Printing and Duplication. (DEC 2015)

(a) Unless otherwise specified in this contract, no printing by the Contractor or any subcontractor is authorized under this contract. All printing required must be performed by the Government Printing Office except as authorized by the Contracting Officer. The Contractor shall submit camera-ready copies to the Contracting Officer’s Representative (COR). The terms “printing” and “duplicating/copying” are defined in the Government Printing and Binding Regulations of the Joint Committee on Printing.

(b) If necessary for performance of the contract, the Contractor may duplicate or copy less than 5,000 production units of only one page, or less than 25,000 production units in aggregate of multiple pages for the use of a department or agency. A production unit is defined as one sheet, size 8.5 x 11 inches, one side only, and one color. The pages may not exceed a maximum image size of 10 ¾ by 14 ¼ inches. This page limit applies to each printing requirement and not for all printing requirements under the entire contract.

€ Approval for all printing, as well as duplicating/copying in excess of the stated limits, shall be obtained from the COR who will consult with the designated publishing services office and provide direction to the contractor. The cost of any unauthorized printing or duplicating/copying under this contract will be considered an unallowable cost for which the Contractor will not be reimbursed.

352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations. (DEC 2015)

(2) In addition to complying with the clause at FAR 52.222-26, Equal Opportunity, the Contractor shall, in good faith, cooperate with the Department of Health and Human Services (Agency) in investigations of Equal Employment Opportunity (EEO) complaints processed pursuant to 29 CFR part 1614. For purposes of this clause, the following definitions apply:

(1) Complaint means a formal or informal complaint that has been lodged with Agency management, Agency EEO officials, the Equal Employment Opportunity Commission (EEOC), or a court of competent jurisdiction.

(2) Contractor employee means all current Contractor employees who work or worked under this contract. The term also includes current employees of subcontractors who work or worked under this contract. In the case of Contractor and subcontractor employees, who worked under this contract, but who are no longer employed by the Contractor or subcontractor, or who have been assigned to another entity within the Contractor’s or subcontractor’s organization, the Contractor shall provide the Agency with that employee’s last known mailing address, email address, and telephone number, if that employee has been identified as a witness in an EEO complaint or investigation.

(3) Good faith cooperation cited in paragraph (a) includes, but is not limited to, making Contractor employees available for:

(i) Formal and informal interviews by EEO counselors or other Agency officials processing EEO complaints;

(ii) Formal or informal interviews by EEO investigators charged with investigating complaints of unlawful discrimination filed by Federal employees;

(iii) Reviewing and signing appropriate affidavits or declarations summarizing statements provided by such Contractor employees during the course of EEO investigations;

(iv) Producing documents requested by EEO counselors, EEO investigators, Agency employees, or the EEOC in connection with a pending EEO complaint; and

(v) Preparing for and providing testimony in depositions or in hearings before the MSPB, EEOC and U.S. District Court.

(b) The Contractor shall include the provisions of this clause in all subcontract solicitations and subcontracts awarded at any tier under this contract.

€ Failure on the part of the Contractor or its subcontractors to comply with the terms of this clause may be grounds for the Contracting Officer to terminate this contract for default.

(End of clause)

352.232-71 Electronic Submission of Payment Requests (Feb 2022)

(a) Definitions. As used in this clause - Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request.

(End of Clause)

352.270-4b Protection of Human Subjects (December 18, 2015)

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

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

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

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

(End of clause)

HHSAR 352.270-6 Restriction on Use of Human Subjects (December 18, 2015) Pursuant to 45 CFR part 46, Protection of Human Research Subjects, the Contractor shall not expend funds under this award for research involving human subjects or engage in any human subjects research activity prior to the Contracting Officer’s receipt of a certification that the research has been reviewed and approved by the Institutional Review Board (IRB) registered with OHRP. This restriction applies to all collaborating sites, whether domestic or foreign, and subcontractors. The Contractor must ensure compliance by collaborators and subcontractors.

(End of clause) CDCA_H009 Key Personnel (Jan 2021)

The key personnel cited below are considered essential to the work performed under the contract. Pursuant to the terms of HHSAR Clause 352.237-75, Key Personnel, the Contractor shall not replace or divert any of these individuals without the written consent of the Contracting Officer.

Project Manager

Task Manager

Analyst IV

CDC42.0002 Evaluation of Contractor Performance Utilizing CPARS (Aug 2021)

In accordance with FAR 42.15, the Centers for Disease Control and Prevention (CDC) will review and evaluate contract performance. FAR 42.1502 and 42.1503 requires agencies to prepare evaluations of contractor performance and submit them to the Contractor Performance Assessment Reporting System (CPARS). The CDC utilizes this web-based system to prepare and report contractor performance evaluations. All information contained in these assessments may be used by the Government, within the limitations of FAR 42.15, for future source selections in accordance with FAR 15.304 where past performance is an evaluation factor.

The CPARS system requires a contractor representative to be assigned so that the contractor has appropriate input into the performance evaluation process. The CPARS contractor representative will be given access to CPARS and will be given the opportunity to concur or not-concur with performance evaluations before the evaluations are complete. The CPARS contractor representative will also have the opportunity to add comments to performance evaluations.

The assessment is not subject to the Disputes clause of the contract, nor is it subject to appeal beyond the review and comment procedures described in the guides on the CPARS website. Refer to: www.cpars.gov for details and additional information related to CPARS, CPARS user access, how contract performance assessments are conducted, and how Contractors participate. Access and training for all persons responsible for the preparation and review of performance assessments is also available at the CPARS website.

The contractor must provide the CDC contracting office with the name, e-mail address, and phone number of their designated CPARS representative who will be responsible for logging into CPARS and reviewing and commenting on performance evaluations. The contractor must maintain a current representative to serve as the contractor representative in CPARS. It is the contractor’s responsibility to notify the CDC contracting office, in writing (letter or email), when their CPARS representative information needs to be changed or updated. Failure to maintain current CPARS contractor representative information will result in the loss of an opportunity to review and comment on performance evaluations.

SECTION D - CONTRACT DOCUMENTS, EXHIBITS OR ATTACHMENTS

Attachment Table

Attachment Number

ATTACHMENT 1

Statement of Work (SOW)

Title of Project: Pre- and Post- Influenza Human Sera Panels Section 1 Background and Need:

Influenza is a highly contagious respiratory disease and epidemics of influenza cause substantial morbidity and mortality worldwide. The Advisory Committee on Immunization Practices (ACIP) recommends influenza vaccination for all persons six months of age and older who do not have contraindications. The seasonal influenza vaccine requires frequent updates due to the constant evolution of influenza viruses resulting in antigenic drift.

As a World Health Organization Collaborating Centers (WHO CC) for Reference and Research on Influenza and a member of the Global Influenza Surveillance Network, the Centers for Disease Control and Prevention (CDC) closely monitors the genetic and antigenic evolution of circulating influenza viruses. The five WHO CCs meet twice each year to recommend the virus strains composition for the upcoming season’s influenza vaccine. The meeting is held every February for the northern hemisphere influenza vaccine recommendations and every September for the southern hemisphere influenza vaccine recommendations. Epidemiological, genetic, antigenic, as well as serological data are critical in guiding vaccine recommendations.

CDC is seeking pre- and post- influenza immunization sera panels from six age cohorts, young pediatric (6 to 35 months), older pediatric and adolescent (3 to 8 years old and 9 to 17 years old), adult (18 to 49 years old), older adult (50 to 64 years old) and elderly (65 years or older) populations to determine if antibodies induced by the current influenza vaccine effectively inhibit currently circulating influenza viruses. The ability of antibodies in post-influenza vaccine serum samples to inhibit hemagglutination or to neutralize currently circulating influenza viruses is a measure of how effective the current vaccine will be at inducing protective antibodies against circulating influenza viruses.

All sera panels shall be tested by hemagglutination inhibition (HI), microneutralizaiton (MN) assays and other immunological assays to evaluate the immune response induced by the current influenza vaccines to newly circulating viruses. HI and MN results will also be analyzed to compare the seroconversions or four-fold rise in titers between pre- and post-vaccination sera induced by the current influenza vaccine to titer response rises demonstrated against newly circulating viruses.

In addition, CDC is seeking large volume post-influenza immunization sera from adult donors for use in hemagglutination inhibition, virus neutralization, and other relevant immunological assays for antigenic characterization of virus isolates submitted to CDC for surveillance and characterization of immune responses following influenza vaccination.

Section 2 Purpose:

This contract is for the provision of anonymous serum samples from six age cohorts (young pediatric, older pediatric, adolescents, adult, older adults, and elderly) with each individual providing blood prior to administration of the specified current, seasonal influenza vaccine (S1) and again 21 to 28 days after immunization (S2). For young pediatric populations (ages 6 to 35 months) and older pediatrics who require two doses of influenza vaccines, the S2 blood will be collected 21 to 28 days after the second dose of influenza vaccine. Serum samples will be tested for vaccine-induced antibodies to determine if the current influenza vaccine strains induce protective levels of antibodies against newly circulating influenza virus strains.

This contract is also for the provision of large volume S2 samples from some of the adult participants for use in hemagglutination inhibition assays with virus isolates and characterization of immune responses following influenza vaccination.

Section 3 Scope of Work:

This is a one-year contract with four, one-year option periods, for the provision of pre- and post- immunization serum samples from eligible young pediatric, older pediatric and adolescent, adult, older adult and elderly participants with the specified current, seasonal, influenza vaccines. All participants within each age panel cohort should receive the same vaccine. For each season, consult with CDC prior to finalizing the vaccines ordered and administered for each panel.

The contractor shall provide pre-and post-immunization serum samples from the age panels listed below:

1). 60 young pediatric participants (age 6 months to 35 months) The 60 pediatric participants between the ages of 6 months and 35 months must be healthy and eligible to receive the influenza vaccine for the first time. Infants and children with a prior history of vaccination or a prior history of laboratory confirmed influenza are excluded from participating. This cohort must receive the current licensed seasonal cell-based and /or egg-based influenza vaccine, or other vaccine type as specified by CDC.

2). 60 older pediatric participants (age 3 years to 8 years) The 60 older pediatric participants between the ages of 3 years to 8 years must be healthy. 30 participants in this cohort must receive the current seasonal egg-based killed virus influenza vaccine and 30 participants in this cohort must receive the current licensed seasonal cell-based killed virus influenza vaccine, or other vaccine type as specified by CDC.

3). 60 older pediatric/adolescent participants (age 9 years to 17 years) The 60 older pediatric/adolescent participants between the ages of 9 years to 17 years must be healthy. 30 participants in this cohort must receive the current seasonal egg-based killed virus influenza vaccine and 30 participants in this cohort must receive the current licensed seasonal cell-based killed virus influenza vaccine, or other vaccine type as specified by CDC.

4). 120 adult participants (age 18 years to 49 years) Adult participants must be between the ages of 18 years to 49 years and healthy.

· 40 participants in this cohort must receive the current seasonal egg-based killed virus influenza vaccine, or other vaccine type as specified by CDC.

· 40 participants in this cohort must receive the current licensed seasonal cell-based killed virus influenza vaccine, or other vaccine type as specified by CDC.

· 40 participants in this cohort must receive the current licensed seasonal recombinant vaccine, or other vaccine type as specified by CDC.

5). 30 older adult participants (age 50 years to 64 years) Older adult participants must be between the ages of 50 years to 64 years and healthy. This cohort must receive the current licensed seasonal egg-based killed virus influenza vaccine, or other vaccine type as specified by CDC.

6). 30 elderly participants (age 65 years and older) Elderly participants must be community dwelling, aged 65 years or older and healthy. This cohort must receive the current licensed seasonal high-dose egg-based killed virus influenza vaccine, or other vaccine type as specified by CDC.

In addition, anyone taking immune suppressing drugs or with a history of an immune compromising disease should be excluded from participation.

The contractor shall arrange for pre-immunization serum samples (S1) to be collected at the first visit followed by administration of the influenza vaccine.

For pediatric ages 9 years to 17 years, adult, older adult, and elderly participants, the contractor shall arrange for a post-immunization serum sample (S2) to be collected 21 to 28 days after the administration of the influenza vaccine.

For young pediatric participants ages 6 months to 35 months, and older pediatric participants ages 3 years to 8 years who require two doses according to recommendations of the ACIP, the contractor shall arrange for a second influenza vaccine to be given four weeks after the first vaccine and a post- immunization serum sample (S2) to be collected 21 to 28 days after administration of the second influenza vaccine dose.

For young pediatric participants ages 6 months to 35 months, the contractor shall arrange for the collection of approximately 5 ml of blood at each visit so that a minimum of 2.5 ml of serum is obtained.