Statement of Work - Assessment Kits.pdf

Statement of Work

Background: Vaccine development and validation requires the measurement of certain parameters within the vaccinated animal(s) to help determine vaccine efficacy, safety, and validity. The main function of the Rieder Lab located in the Foreign Animal Disease Research Unit, Plum Island Animal Disease Center, is novel vaccine design and development against Foot-and-Mouth disease (FMD) in livestock. This disease has devastating economic consequences, animal welfare concerns, as well as potential disastrous effects on global food security. Work is also of particular importance not only to control and eventually eradicate the disease, but also to protect FMD- free countries from incursion of the virus. In addition to the effect of the disease on animal health, billions of dollars in trade and economic loss due to disease manifestation in FMD free countries are at stake. Important parameters to measure in vaccinated animals include those which pertain to the immune system and the immune responses of the animals in order to assess these kinds of parameters, specific reagents and kits are required. The objective in using the specified items requested herein is to assess cellular and molecular level immune responses in animals (cows and pigs) during vaccine development.

Requirements: ELISpot kits are used to measure the immune responses of individual cells to a pathogen (specifically, the foot- and-mouth disease virus (FMDV).) These responses are measured by the capture of a specific protein which is produced by the cell, and then visualized through a chemical reaction (one spot = 1 cell). Spots will then be read and counted by a specific machine, CTL Immunospot, and counts analyzed. Specific ELISpot kits will measure individual cells producing the cellular factor, for example, interferon gamma (IFNγ), in response to vaccination and exposure of cells to the virus. The kits can measure up to 1600 cells per treatment per animal. (Cells from an animal are exposed to different relevant viruses or controls to specifically assess responses to different viruses (treatment).) We will then extrapolate the percentage of cells within the animal which are involved in protecting the animal against the virus. ELISA kits are used to measure the immune responses of animals by measuring specific proteins found circulating in the blood stream. These proteins are produced by many cells in response to vaccination or infection. Different proteins are produced depending on the type of immune response an animal is having. ELISA kits will generate similar data, though looking at other cellular factors, and importantly, on a systemic (rather than cellular) level. Antibodies will also be used to measure specific proteins of the individual cells. Additional reagents will be required to supplement those in the kits and for use in the development of additional assays to create a broader view of the immune response(s). See Attachment 01 for specific items and estimated yearly quantities.

Testing and Verification: All kits and reagents are to conform to the manufacturer standards in place.

Data Requirements: All kits and reagents shall include protocols, recommended uses, Safety Data Sheets, storage conditions, and uses of the reagents, kits, and antibodies.

Technical Support: Kit and Reagent Technical Support shall be provided within the vendor’s specified hours and means (telephone, email, chat).

Packaging, Shipping and Delivery: Standard commercial practices will be engaged with packaging.

Packaging shall be sufficient to protect the contents from degradation, environmental elements, and damage. Shipping shall be FOB Destination, Orient, NY (all shipping costs included) and will be conducted in such a manner as the items arrive within no more than 2 weeks after receipt of order.

Delivery shall be FOB Destination to the following address below via an appropriate carrier (USPS, UPS, FedEx, etc.)

USDA, ARS, Plum Island Animal Disease Center 40550 Route 25 Orient, NY 11957

ATTACHMENT 01 – Line Items

Terms & Conditions for Commercial Items Current to: FAC 2021-05 Effective March 10, 2021

Provisions/Clauses Incorporated by Reference: This order incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. The full text of a clause may be accessed electronically at the following address: https://www.acquisition.gov/far.

52.204-7 System for Award Management (Oct 2018) 52.212-4 Contract Terms and Conditions - Commercial Items (Oct 2018)

52.212-5 - CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS— COMMERCIAL ITEMS (Jan 2021)

(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) (31U.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) 52.203-6, Restrictions on Subcontractor Sales to the Government (Jun 2020), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402). (Applies if >SAT)

(2) 52.203-13, Contractor Code of Business Ethics and Conduct (Jun 2020)(41 U.S.C. 3509). (Applies if >$5.5 million & POP >120 days)

(3) 52.203-15, 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.)

XX (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jun 2020) (Pub. L.

109-282) (31 U.S.C. 6101 note). (Applies if >$30,000.)

(5) [Reserved]

(6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of

Div. C). Reporting required for (i) All cost-reimbursement, time/materials, labor-hour service contracts, estimated above 250,000. (ii) All fixed-price service contracts awarded/orders issued according to following following thresholds: (A) Awarded in FY 2014, with an estimated total value of =/>$2.5 million. (B) Awarded in FY 2015, with an estimated total value of $1 million or greater. (C) Awarded in FY 2016, and subsequent years, with estimated total value > $500,000.

(7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C). Reporting required for (i) All cost-reimbursement, time/materials, labor-hour service contracts, estimated above 250,000. (ii) All fixed-price service contracts awarded/orders orders issued according to following thresholds: (A) Awarded in FY 2014, with an estimated total value of total value of =/>$2.5 million. (B) Awarded in FY 2015, with an estimated total value of $1 million or greater. (C) Awarded in FY 2016, and subsequent years, with estimated total value > $500,000.

XX (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Jun 2020) (31 U.S.C. 6101 note). (Applies >$35,000)

(9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Oct 18)(41 U.S.C. 2313). (Applies if >$550,000 & offeror checked “has” paragraph (b) of provision at 52.209-7)

(10) [Reserved]

(11) 52.219-3, 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.

(12) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Mar 20)

(If 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.

(13) [Reserved]

XX(14)(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.

(15)(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.

(16) 52.219-8, Utilization of Small Business Concerns (Oct 2018) (15 U.S.C. 637)(d)(2) and (3)).

(Applies over $250,000.)

(17)(i) 52.219-9, Small Business Subcontracting Plan (Jun 2020) (15 U.S.C. 637(d)(4)). (Applies only to large business prime contractors.) (Applies if expected to exceed $700,000.)

(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 2020) of 52.219-9.

__(18) 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.

(19) 52.219-14, Limitations on Subcontracting (Mar 2020) (15 U.S.C. 637(a)(14)). (Applies if expected to exceed $250,000.)

(20) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

(Applies only to large business prime contractors.)

(21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Mar 2020) (15 U.S.C. 657 f).

XX(22) (I) 52.219-28, Post Award Small Business Program Representation (Nov 2020) (15 U.S.C.632(a)(2)).

(ii) Alternate I (Mar 2020) of 59.219-28.

(23) 52.219-29, 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)).

(24) 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 (Mar 2020)(15 U.S.C.637(m)).

(25) 52.219-32, Orders Issued Directly Under Small Business Reserves (Mar 2020) (15 U.S.C. 644(r)).

(26) 52.219-33, Nonmanufacturer Rule (Mar 2020) (15 U.S.C. 637(a)(17)).

XX (27) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

XX (28) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Jan 2020) (E.O. 13126).

XX (29) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

XX (30)(i) 52.222-26, Equal Opportunity (Sep 2016) (E.O. 11246).

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

__ (31) (i)52.222-35, Equal Opportunity for Veterans (Jun 2020) (38 U.S.C. 4212).(Applies >$150,000)

(ii) Alternate I (July 2014) of 52.222-35.

XX (32) (i) 52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020) (29 U.S.C. 793). (Applies if >$15,000)

(ii) Alternate I (July 2014) of 52.222-36.

(33) 52.222-37, Employment Reports on Veterans (Jun 2020) (38 U.S.C.4212)(Applies>$150,000)

(34) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 10) (E.O.

13496). Flow down required in accordance with paragraph (f) of 52.222-40.

XX (35) (i) 52.222-50, Combating Trafficking in Persons (Oct 2020) (22 U.S.C. chapter 78, E.O. 13627).

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

(36) 52.222-54, 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.) (Applies if >SAT.)

(37)(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 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 acquisition of commercially available off-the-shelf items.)

(38) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydro-fluorocarbons (Jun 2016) (E.O.13693).

(39) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air Conditioners (Jun 2016) (E.O. 13693).

(40) (i) 52.223-13, Acquisition of EPEAT® -Registered Imaging Equipment (Jun 2014) (E.O.s 13423 and 13514)

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

(41)(i) 52.223-14, Acquisition of EPEAT® -Registered Television (Jun 2014) (E.O.s 13423 and 13514).

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

(42) 52.223-15, Energy Efficiency in Energy-Consuming Products (May 2020) (42 U.S.C. 8259b).

(43) (i) 52.223-16, Acquisition of EPEAT® -Registered Personal Computer Products (Oct 2015) (E.O.s

13423 and 13514).

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

XX (44) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Jun 2020).

(45) 25.223-20, Aerosols (Jun 2016) (E.O. 13693).

(46) 52.223-21, Foams (Jun 2016) (E.O. 13696).

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

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

(48) 52.225-1, Buy American Act—Supplies (Jan 2021) (41 U.S.C. chapter 83).

(49) (i) 52.225-3, Buy American--Free Trade Agreements--Israeli Trade Act (Jan 2021) (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.

(50) 52.225-5, Trade Agreements (Oct 2019) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301)(FAR25.1101(c))

XX

52.217-9 Option to Extend the Term of the Contract 52.225-4 Buy American-Free Trade Agreements-Israeli Trade Act Certificate

XX (51) 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) (E.O.’s, proclamations, and statutes administered by Office of Foreign Assets Control of Department of Treasury).

(52) 52.225-26, Contractors Performing Private Security Functions Outside United States (Oct 2016) (Section 862, as amended, National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C.

2303Note).

(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).

(55) 52.229-12, Tax on Certain Foreign Procurements (Jun 2020).

__ (56) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 255(f), 10 U.S.C. 2307(f)).

(57) 52.232-30, Installment Payments for Commercial Items (Jan 2017) (41 U.S.C. 255(f), 10 U.S.C. 2307(f)).

XX (58) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct 2018) (31 U.S.C. 3332).

XX (59) 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management (Jul 2013) (31 U.S.C. 3332).

(60) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

(61) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a). (Applies to certain IT acquisitions) ___(62) 52.242-5, Payments to Small Business Subcontractors (Jan 2017)(15 U.S.C. 637(d)(12)).

(63)(i) 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).

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

(ii) Alternate I (Feb 2006) 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 items:

__(1) 52.222-41, Service Contract Labor Standards (Aug 2018) (41 U.S.C. chapter 67). (Applies to service contracts >$2,500) __ (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). (Applies if SCA & >$2,500) __ (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) (29 U.S.C. 206 and 41 U.S.C. chapter 67). (When FAR 52.222-41 is included & >SAT) __ (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). __ __(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 Under Executive Order 13658 (Nov 2020)(E.O. 13658).

__ (8) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706). (When FAR 52.222-6 or 52.222-41 is included).

__(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, 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.

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 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 resolved.

(2) 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 $700,000 ($1.5 million for construction of any public facility), 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)52.222-50, Combating Trafficking in Persons (Oct 2020) (22 U.S.C. 7104(g)).

Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. 7104(g)).

(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).

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

(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 National Defense Authorization Act 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.

52.217-9 Option to Extend the Term of the Contract 52.225-4 Buy American-Free Trade Agreements-Israeli Trade Act Certificate