RFQ 75N91023Q00019.pdf

STATEMENT OF NEED (SON)

RFQ No. 75N91023Q00019

SECTION 1 – REQUIRED ITEMS AND PRICING

1.1 TITLE

Acquisition of Nilotinib (Tasigna®) Capsules, or Equivalent

1.2 BACKGROUND

The National Cancer Institute (NCI), Division of Cancer Treatment and Diagnosis (DCTD), Cancer Therapy Evaluation Program (CTEP), requires Tasigna® capsules, or equivalent, for the conduct of clinical trial NCI Protocol EAY191-E4 “Nilotinib and Paclitaxel in Patients with Prior Taxane- Treated Solid Tumors.”

Nilotinib (Tasigna®) is an inhibitor of the BCR-ABL kinase. Nilotinib binds to and stabilizes the inactive conformation of the kinase domain of ABL protein. In vitro, nilotinib inhibited BCR-ABL mediated proliferation of murine leukemic cell lines and human cell lines derived from patients with Ph+ CML. Under the conditions of the assays, nilotinib was able to overcome resistance resulting from BCR-ABL kinase mutations, in 32 out of 33 mutations tested. Nilotinib inhibited the autophosphorylation of the following kinases: BCR-ABL, PDGFR, c-KIT, CSF-1R, and DDR1.

1.3 CONTRACT TYPE

The contract type shall be Indefinite Delivery Indefinite Quantity (IDIQ). Delivery orders issued under this IDIQ contract shall be firm fixed price.

1.4 MINIMUM AND MAXIMUM QUANTITIES (IDIQ)

The contract minimum for the entire period of performance, including any options, shall be as follows:

150 mg capsules - 120 blisters containing 28 capsules each 200 mg capsules - 36 blisters containing 28 capsules each

The contract maximum for the entire period of performance, including any options, shall be as follows:

150 mg capsules - 800 blisters containing 28 capsules each 200 mg capsules - 240 blisters containing 28 capsules each

1.5 CONTRACT LINE ITEM PRICING (IDIQ)

The price for each firm fixed price delivery order shall be based on the prices listed below:

ITEM

YEAR 1 UNIT

PRICE (one blister containing 28 capsules each)

YEAR 2 UNIT

PRICE (one blister containing 28 capsules each)

YEAR 3 UNIT

PRICE (one blister containing 28 capsules each)

YEAR 4 UNIT

PRICE (one blister containing 28 capsules each)

Nilotinib 150 mg capsules $(TBD at award) $(TBD at award) $(TBD at award) $(TBD at award)

Nilotinib 200 mg capsules $(TBD at award) $(TBD at award) $(TBD at award) $(TBD at award)

SECTION 2 – ITEM DESCRIPTION / SPECIFICATIONS

2.1 PRODUCT FEATURES/SALIENT CHARACTERISTICS

The contractor shall provide the following product with features/characteristics as described:

• Nilotinib (Tasigna®) 150 mg (brand name or equal):

o Capsule formulation, hard gelatin size 1 o Capsules containing nilotinib monohydrochloride monohydrate salt, equivalent to 150 mg of nilotinib base, anhydrous o Blisters shall contain 28 capsules each

• Nilotinib (Tasigna®) 200 mg (brand name or equal):

o Capsule formulation, hard gelatin size 0 o Capsules containing nilotinib monohydrochloride monohydrate salt, equivalent to 200 mg of nilotinib base, anhydrous o Blisters shall contain 28 capsules each

• The capsule expiration date shall not be less than 18-months from the date of receipt by the NCI.

• Blisters shall be stored and shipped at controlled room temperature (20-25OC) in accordance with the storage conditions defined on the drug product container label to ensure required temperature conditions from the time of shipment until the time of delivery. Each shipment shall include a temperature monitoring device.

• The Contractor shall be an FDA-approved manufacturer, or authorized wholesaler, distributor, licensed third-party logistic provider, or licensed specialty pharmacy, meeting the specifications required herein. The Contractor must be registered as a drug establishment with the FDA or licensed with respective state authority and licensure reported to the FDA in accordance with the FDA Drug Supply Chain and Security Act.

SECTION 3 – DELIVERIES AND PERFORMANCE

3.1 PACKAGING AND MARKING

All deliverables shall be delivered to the applicable Contracting Officer’s Representative (COR) or NCI Technical point of contact (TPOC) identified in each delivery order and shall be marked as follows:

1. Name and address of the Contractor;

2. Contract Number;

3. Description of item(s) contained therein; and

4. Consignee's name and address.

3.2 INSPECTION AND ACCEPTANCE

Pursuant to FAR clause 52.212-4, all required items described in Section 2.1, to be delivered under each delivery order, are subject to final inspection and acceptance by an authorized representative of the Government. The authorized representative of the Government is the COR or TPOC, as specified in each delivery order, who is responsible for the inspection and acceptance of all supplies to be provided by the Contractor.

3.3 DELIVERABLES AND DELIVERY SCHEDULE

The Contractor shall supply transaction information, transaction statements and transaction history for the provided drug product lots in accordance with the FDA Drug Supply Chain and Security Act for each delivery order.

Required items shall be delivered to the following address within 30 calendar days or as specified in individual delivery orders:

NCI Clinical Repository /Fisher BioServices 4650 New Design Road, Suite D Frederick, MD 21703

3.4 DELIVERY REQUIREMENTS

Pickup and delivery of items under this contract shall be accomplished between the hours of 9:00 a.m. and 4:00 p.m., Monday through Friday unless changed by mutual agreement between the COR and the Contractor. No deliveries shall be made on Saturdays, Sundays, and days of Government closure or Federal legal holidays found at: https://www.opm.gov/policy-data-oversight/pay-leave/federal-holidays/.

3.5 PERIOD OF PERFORMANCE

The anticipated period of performance of the resulting IDIQ award shall consist of a 4-year ordering period from the date of award.

SECTION 4 – CONTRACT ADMINISTRATION

4.1 CONTRACTING OFFICER'S REPRESENTATIVE (COR) AUTHORITY

(a) Materials/items to be delivered under this contract must be subject to the technical direction of the Contracting Officer's Representative, or NCI Technical point of contact (TPOC).

The term "technical direction" includes, without limitation, direction to the Contractor that directs or redirects the labor effort, shifts the work between work areas or locations, fills in details and otherwise serves to ensure that tasks/requirements outlined in the statement of need are accomplished satisfactorily.

(b) Technical direction must be within the scope of the specification(s)/statement of need.

The COR/ TPOC does not have authority to issue technical direction that:

(1) Constitutes a change of assignment or additional work outside the specification(s)/statement of need;

(2) Constitutes a change as defined in the clause entitled "Changes";

(3) In any manner causes an increase or decrease in the contract price, or the time required for contract performance/delivery;

(4) Changes any of the terms, conditions, or specification(s) of the contract;

(5) Interferes with the Contractor's right to perform under the terms and conditions of the contract; or

(6) Directs, supervises or otherwise controls the actions of the Contractor's employees.

https://www.opm.gov/policy-data-oversight/pay-leave/federal-holidays/ https://www.opm.gov/policy-data-oversight/pay-leave/federal-holidays/

(c) Technical direction may be oral or in writing. The COR/ TPOC shall confirm oral direction in writing within five workdays, with a copy to the Contracting Officer.

(d) The Contractor shall proceed promptly with performance resulting from the technical direction issued by the COR/ TPOC. If, in the opinion of the Contractor, any direction of the COR/ TPOC, or his/her designee, falls within the limitations in (b), above, the Contractor shall immediately notify the Contracting Officer no later than the beginning of the next Government workday.

(e) Failure of the Contractor and the Contracting Officer to agree that technical direction is within the scope of the contract shall be subject to the terms of the clause entitled "Disputes."

A COR/ TPOC will be appointed/specified in individual delivery orders.

4.2 INVOICE SUBMISSION / PAYMENT

Payment shall be made upon delivery, inspection and acceptance by the Government. Payment authorization requires submission and approval of invoices to the NCI COR and NIH OFM, in accordance with the payment provisions listed below:

The following clause is applicable to all Purchase Orders, Task or Delivery Orders, and Blanket Purchase Agreement (BPA) Calls: Prompt Payment (Jan 2017) FAR 52.232-25. Highlights of this clause and NIH implementation requirements follow:

I. Invoice Requirements

A. An invoice is the Contractor's bill or written request for payment under the contract for supplies delivered or services performed. A proper invoice is an "Original" which must include the items listed in subdivisions 1 through 12, below, in addition to the requirements of FAR 32.9. If the invoice does not comply with these requirements, the Contractor will be notified of the defect within 7 days after the date the designated billing office received the invoice (3 days for meat, meat food products, or fish, and 5 days for perishable agricultural commodities, dairy products, edible fats, or oils) with a statement of the reasons why it is not a proper invoice. (See exceptions under II., below.) Untimely notification will be considered in the computation of any interest penalty owed the Contractor.

1. Vendor/Contractor: Name, Address, Point of Contact for the invoice (Name, title, telephone number, e-mail and mailing address of point of contact).

2. Remit-to address (Name and complete mailing address to send payment).

3. Remittance name must match exactly with name on original order/contract. If the Remittance name differs from the Legal Business Name, then both names must appear on the invoice.

4. Invoice date.

5. Unique invoice #s for all invoices per vendor regardless of site.

6. NBS document number formats must be included for awards created in the NBS: Contract Number; Purchase Order Number; Task or Delivery Order Number and Source Award Number (e.g., Indefinite Delivery Contract number; General Services Administration number);

or, BPA Call Number and BPA Parent Award Number.

7. Unique Entity Identifier (UEI) which is in the System for Award Management (SAM) and replaces the Dun & Bradstreet Data Universal Numbering System (DUNS) number.

8. Federal Taxpayer Identification Number (TIN). In those rare cases where a contractor does not have a UEI number or TIN, a Vendor Identification Number (VIN) must be referenced on the invoice.

The VIN is the number that appears after the contractor’s name on the face page of the award document.

9. Identify that payment is to be made using a three-way match.

10. Description of supplies/services that match the description on the award, by line billed.*

11. Freight or delivery charge must be billed as shown on the award. If it is included in the item price do not bill it separately. If identified in the award as a separate line item, it must be billed separately.

12. Quantity, Unit of Measure, Unit Price, Extended Price of supplies delivered or services performed, as applicable, and that match the line items specified in the award.*

NOTE: If your invoice must differ from the line items on the award, please contact the Contracting Officer before submitting the invoice. A modification to the order or contract may be needed before the invoice can be submitted and paid.

Shipping costs will be reimbursed only if authorized by the Contract/Purchase Order. If authorized, shipping costs must be itemized. Where shipping costs exceed $100, the invoice must be supported by a bill of lading or a paid carrier's receipt.

B. The Contractor shall submit invoices to the Department of Treasury’s

Invoice Processing Platform (IPP) at https://www.ipp.gov with a copy to the approving official, as directed below.

The Contractor shall submit a copy of the electronic invoice to the following Approving Official (Contracting Officer) and Contracting Officer’s Representative:

https://www.ipp.gov/

II. Invoice Payment A. Except as indicated in paragraph B., below, the due date for making invoice payments by the designated payment office shall be the later of the following two events:

1. The 30th day after the designated billing office has received a proper invoice.

2. The 30th day after Government acceptance of supplies delivered or services performed.

B. The due date for making invoice payments for meat and meat food products, perishable agricultural commodities, dairy products, and edible fats or oils, shall be in accordance with the Prompt Payment Act, as amended.

III. Interest Penalties A. An interest penalty shall be paid automatically, if payment is not made by the due date and the conditions listed below are met, if applicable.

1. A proper invoice was received by the designated billing office.

2. A receiving report or other Government documentation authorizing payment was processed and there was no disagreement over quantity, quality, or contractor compliance with a term or condition.

3. In the case of a final invoice for any balance of funds due the contractor for supplies delivered or services performed, the amount was not subject to further settlement actions between the Government and the Contractor.

B. Determination of interest and penalties due will be made in accordance with the provisions of the Prompt Payment Act, as amended, the Contract Disputes Act, and regulations issued by the Office of Management and Budget.

IV. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS

SUBCONTRACTORS, FAR 52.232-40 (November 2021)

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

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

(c) Include the substance of this clause, including this paragraph (c), in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial products or commercial services.

(End of Clause)

V. HHSAR 352.232-71 Electronic Submission of Payment Requests (February 2, 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)

SECTION 5 – SPECIAL CONTRACT REQUIREMENTS

5.1 CONTRACTOR PERFORMANCE EVALUATION(S)

During the life of this contract, Contractor performance will be evaluated on an interim and final basis pursuant to FAR Subpart 42.15. The Contractor Performance Assessment Reporting System (CPARS) will be utilized for these reviews. Information on CPARS can be located at http://www.cpars.gov.

5.2 ORDERING PROCEDURES (IDIQ)

a. The Contractor will be provided with a description of the schedule, deliverables and http://www.ipp.gov/ other additional instructions as needed for each individual delivery order to be issued under this contract. Requests for delivery order quotations will be issued by email.

b. Requests for delivery order quotations will include special instructions that are particular to the requirement and information concerning the basis for award. The basis for award of any delivery order will be determined by the specific programmatic needs of the requesting agency but will be in accordance with FAR Part 16.505.

c. Individual delivery order evaluation and award will be conducted in accordance with the requirements of FAR 16.5. The Government reserves the right to request quotation revisions that seek additional price discounts, provide revisions to the technical quotation, or clarify aspects of the quotation.

5.3 DELIVERY ORDER INFORMATION (IDIQ)

a. Each delivery order will contain the following minimum information:

(1) Date of award;

(2) Contract number and delivery order number;

(3) Total dollar amount of the delivery order;

(4) Statement of Need, schedule of deliverables and any special instructions;

(5) The name and address of the delivery order COR, if applicable.

b. The Contractor shall submit separate invoices for each delivery order.

SECTION 6 – CONTRACT CLAUSES

52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES

OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES. (OCT

2022)

(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 and Other Covered Entities (Nov 2021) (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) 52.233-3, 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 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. 2402).

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

__ (5) [Reserved].

__ (6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L.

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

__ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016) (Pub. L. 111-117, section 743 of Div. C).

X (8) 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).

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

__ (10) [Reserved].

__ (11) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Oct 2022) (

15 U.S.C. 657a).

X (12) 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).

__ (13) [Reserved] X (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.

X (16) 52.219-8, Utilization of Small Business Concerns (Oct 2022) ( 15 U.S.C.

637(d)(2) and (3)).

(17) (i) 52.219-9, Small Business Subcontracting Plan (Oct 2022) ( 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 2021) of 52.219-9.

___(18) (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.

_X_(19) 52.219-14, Limitations on Subcontracting (Oct 2022) ( 15 U.S.C. 637s).

(20) 52.219-16, Liquidated Damages—Subcontracting Plan (Sep 2021) ( 15 U.S.C.

637(d)(4)(F)(i)).

__ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set- Aside (Oct 2022) ( 15 U.S.C. 657f).

X (22) (i) 52.219-28, Post Award Small Business Program Rerepresentation (Oct 2022) ( 15 U.S.C. 632(a)(2)).

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

__ (23) 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)).

__ (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 (Oct 2022) ( 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 (Sep 2021) ( 15U.S.C. 637(a)(17)).

X (27) 52.222-3, Convict Labor (Jun 2003) (E.O.11755).

X (28) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2022) (E.O.13126).

X (29) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

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

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

X (31) (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 (32) (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 (33) 52.222-37, Employment Reports on Veterans (Jun 2020) ( 38 U.S.C. 4212).

__(34) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

X (35) (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).

__ (36) 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.)

__ (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 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.)

__ (38) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons (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 Televisions (Jun 2014) (E.O.s 13423 and 13514).

__ (ii) Alternate I (Jun2014) 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.

X (44) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Jun 2020) (E.O. 13513).

__ (45) 52.223-20, Aerosols (Jun 2016) (E.O. 13693).

__ (46) 52.223-21, Foams (Jun2016) (E.O. 13693).

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

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

X (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 (Oct 2022) ( 41 U.S.C.chapter83, 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 (Jan 2021) of 52.225-3.

__ (iii) Alternate II (Jan 2021) of 52.225-3.

__ (iv) Alternate III (Jan 2021) of 52.225-3.

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

__ (50) 52.225-5, Trade Agreements (Oct 2019) ( 19 U.S.C. 2501, et seq., 19 U.S.C.

3301 note).

X (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. 2302Note).

__ (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 (Nov2007) ( 42 U.S.C. 5150).

__ (55) 52.229-12, Tax on Certain Foreign Procurements (Feb 2021).

__ (56) 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. 2307(f)).

__ (57) 52.232-30, Installment Payments for Commercial Products and Commercial Services (Nov 2021) ( 41 U.S.C. 4505, 10 U.S.C. 2307(f)).

X (58) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct2018) ( 31 U.S.C. 3332).

__ (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).

__ (62) 52.242-5, Payments to Small Business Subcontractors (Jan 2017) ( 15 U.S.C. 637(d)(13)).

__ (63) (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) 52.203-19, 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 (Nov 2021) (Section 1634 of Pub. L. 115-91).

(iv) 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).

(v) 52.219-8, Utilization of Small Business Concerns (Oct 2022) ( 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 (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).

(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 (May 2022) (E.O. 12989).

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

(xviii) 52.222-62, Paid Sick Leave Under Executive Order 13706 (Jan 2022) (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

(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)

FAR 52.216-18 ORDERING (AUG 2020)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from February 1, 2023, through January 31, 2027.

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) A delivery order or task order is considered "issued" when—

(1) If sent by mail (includes transmittal by U.S. mail or private delivery service), the Government deposits the order in the mail;

(2) If sent by fax, the Government transmits the order to the Contractor's fax number;

or

(3) If sent electronically, the Government either—

(i) Posts a copy of the delivery order or task order to a Government document access system, and notice is sent to the Contractor; or

(ii) Distributes the delivery order or task order via email to the Contractor's email address.

(d) Orders may be issued by methods other than those enumerated in this clause only if authorized in the contract.

(End of clause)

FAR 52.216-19 ORDER LIMITATIONS (OCT 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than (TBD at award), the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor—

(1) Any order for a single item in excess of (TBD at award);

(2) Any order for a combination of items in excess of (TBD at award); or

(3) A series of orders from the same ordering office within 30 days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within 15 days after issuance, with written notice stating the Contractor’s intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

FAR 52.216-22 INDEFINITE QUANTITY (OCT 1995)

(a) This is an indefinite-quantity contract for the supplies specified, and effective for the period stated, in the Schedule. The quantities of supplies specified in the Schedule are estimates only and are not purchased by this contract.

(b) Delivery shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies specified in the Schedule up to and including the quantity designated in the Schedule as the “maximum.” The Government shall order at least the quantity of supplies or services designated in the Schedule as the “minimum.”

(c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations.

(d) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor’s and Government’s rights and obligations with respect to that order to the same extent as if the order were completed during the contract’s effective period; provided, that the Contractor shall not be required to make any deliveries under this contract after three (3) years from the date of delivery order award.

(End of Clause)

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 https://www.acquisition.gov/hhsar

FEDERAL ACQUISITION REGULATION (FAR) – CLAUSES INCORPORATED BY REFERENCE:

CLAUSE NO. TITLE

FAR 52.203-17 Contractor Employee Whistleblower Rights and Requirement to

Inform Employees of Whistleblower Rights (Jun 2020) FAR 52.204-13 System for Award Management Maintenance (OCT 2018) FAR 52.204-18 Commercial and Government Entity Code Maintenance (AUG

2020) FAR 52.212-4 Contract Terms and Conditions- Commercial Products and

Commercial Services. (NOV 2021) FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors

(NOV 2021)

HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) – CLAUSES

INCORPORATED BY REFERENCE:

Clause No. Title

HHSAR 352.203-70 Anti-lobbying (DEC 2015) HHSAR 352.208-70 Printing and Duplication (DEC 2015) HHSAR 352.227-70 Publications and Publicity (DEC 2015) HHSAR 352.232-71 Electronic Submission of Payment Requests (FEB 2022) HHSAR 352.237-74 Non-Discrimination in Service Delivery (DEC 2015)

(END OF CONTRACT CLAUSES)

https://www.acquisition.gov/browse/index/far

SECTION 7 – SOLICITATION INFORMATION

7.1 SOLICITATION PROVISIONS

FAR 52.211-6 Brand Name or Equal (Aug 1999)

(a) If an item in this solicitation is identified as "brand name or equal," the purchase description reflects the characteristics and level of quality that will satisfy the Government’s needs. The salient physical, functional, or performance characteristics that "equal" products must meet are specified in the solicitation.

(b) To be considered for award, offers of "equal" products, including "equal" products of the brand name manufacturer, must-

(1) Meet the salient physical, functional, or performance characteristic specified in this solicitation;

(2) Clearly identify the item by-

(i) Brand name, if any; and

(ii) Make or model number;

(3) Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and

(4) Clearly describe any modifications the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modifications.

(c) The Contracting Officer will evaluate "equal" products on the basis of information furnished by the offeror or identified in the offer and reasonably available to the Contracting Officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer.

(d) Unless the offeror clearly indicates in its offer that the product being offered is an "equal" product, the offeror shall provide the brand name product referenced in the solicitation.

(End of provision)

52.225-2 BUY AMERICAN CERTIFICATE (OCT 2022)

(a) (1) The Offeror certifies that each end product, except those listed in paragraph (b) of this provision, is a domestic end product and that each domestic end product listed in paragraph (c) of this provision contains a critical component.

(2) The Offeror shall list as foreign end products those end products manufactured in the United States that do not qualify as domestic end products. For those foreign end products that do not consist wholly or predominantly of iron or steel or a combination of both, the Offeror shall also indicate whether these foreign end products exceed 55 percent domestic content, except for those that are COTS items. If the percentage of the domestic content is unknown, select “no”.

(3) The Offeror shall separately list the line item numbers of domestic end products that contain a critical component (see FAR 25.105).

(b) Foreign End Products:

(4) The terms “commercially available off-the-shelf (COTS) item,” “critical component,” "domestic end product," "end product," and "foreign end product" are defined in the clause of this solicitation entitled "Buy American-Supplies."

Line Item No. Country of Origin Exceeds 55% domestic content (yes/no)

[List as necessary]

(c) Domestic end products containing a critical component:

Line Item No. ___

[List as necessary]

(d) The Government will evaluate offers in accordance with the policies and procedures of part 25 of the Federal Acquisition Regulation.

(End of provision) https://www.acquisition.gov/far/25.105#FAR_25_105 https://www.acquisition.gov/far/part-25#FAR_Part_25

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 this/these address(es):

www.acquisition.gov/browse/index/far

FEDERAL ACQUISITION REGULATION (FAR) – PROVISIONS INCORPORATED BY REFERENCE:

PROVISION NO. TITLE

FAR 52.203-18 Prohibition on Contracting with Entities that Require Certain Internal

Confidentiality Agreements or Statements-Representation (JAN 2017) FAR 52.204-7 System for Award Management (OCT 2018) FAR 52.204-16 Commercial and Government Entity Code Reporting (AUG 2020) FAR 52.204-22 Alternative Line-Item Proposal (JAN 2017) FAR 52.207-6 Solicitation of Offers from Small Business Concerns and Small Business

Teaming Arrangements or Joint Ventures (Multiple-Award Contracts)

(OCT 2016)

FAR 52.209-7 Information Regarding Responsibility Matters (2018) FAR 52.212-1 Instructions to Offerors—Commercial Products and Commercial Services

(NOV 2021)

FAR 52.222-56 Certification Regarding Trafficking in Persons Compliance Plan

(OCT 2020)

FAR 52.229-11 Tax on Certain Foreign Procurements (JUN 2020)

HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48 CFR CHAPTER 3)

PROVISIONS:

PROVISION NO. TITLE

HHSAR 352.203-70 ANTI-LOBBYING (DEC 2015)

HHSAR 352.208-70 PRINTING AND DUPLICATION (DEC 2015)

HHSAR 352.222-70 CONTRACTOR COOPERATION IN EQUAL EMPLOYMENT OPPORTUNITY

INVESTIGATION (DEC 2015)

HHSAR 352.224–71 CONFIDENTIAL INFORMATION (DEC 2015)

HHSAR 352.227–70 PUBLICATIONS AND PUBLICITY (DEC 2015)

HHSAR 352.237–74 NON-DISCRIMINATION IN SERVICE DELIVERY (DEC 2015)

http://www.acquisition.gov/browse/index/far

7.2 QUOTE SUBMISSION / EVALUATION

GENERAL INSTRUCTIONS

This Request for Quotation (RFQ) does not commit the Government to pay any cost for the preparation and submission of a quote. In addition, the Contracting Officer is the only individual who can legally commit the Government to the expenditure of public funds in connection with this proposed acquisition. By submitting a quote in response to this solicitation, it is understood that your firm’s quote shall become a part of the official contract file. The Government is not responsible for locating or securing any information which the Quoter does not include or identify in their quotation.

QUESTION SUBMISSIONS

Please submit questions concerning this RFQ via email no later than 11:00 A.M. EST on 27, December, 2022 (12/27/2022) to the point of contact listed below:

Name: Dana Summons Contract Specialist Email: Dana.summons@nih.gov

Note: Questions submitted by a method other than email will not be accepted. Any questions received after the specified cut-off time and date above will not be accepted or answered unless at the Contracting Officer’s discretion is deemed necessary. Additionally, all questions and answers of common interest will be provided to all prospective offerors via an amendment to the posting. All emails must include the Solicitation number 75N91023Q00019 in the subject line.

QUOTATION SUBMISSIONS

Quotations submitted in response to this solicitation must be submitted via email no later than 3:00 P.M. EST on 4 January 2023 (1/04/2023) to the point of contract listed below:

Name: Dana Summons Contract Specialist Email: Dana.summons@nih.gov

All quotations shall provide enough information for the Government to conduct a thorough evaluation of the quotes provided, and the quoter’s ability to fulfill the stated needs within this RFQ. At a minimum all quotes shall include in the following:

1. Cover letter including:

a) Federal Tax Identification Number (TIN);

mailto:Dana.summons@nih.gov mailto:Dana.summons@nih.gov

b) Unique Entity Identifier (UEI);

c) Cage Code;

d) Business size and designation (i.e., Small, Other than Small);

e) Point of Contact Information for individuals authorized to commit on behalf of their organization. Including name, address, and telephone number of the offeror;

f) A statement to the effect that pricing is firm for a period of at least 60 days from the date of receipt thereof by the Government.

2. Pricing and discount terms;

3. A completed copy of the representations and certifications at Federal Acquisition

Regulation (FAR) 52.212-3 (see FAR 52.212-3(b)) for those representations and certifications that the offeror shall complete electronically) (See attachment 2 to the Combined Synopsis Solicitation);

4. Quoter Certification

Quotes shall include one of the following:

a) a completed copy of the provision at FAR 52.204-26 Covered Telecommunications Equipment or Services-Representation, dated October 2020 (see section 7.1); OR

b) a copy of the firm’s completed annual representations and certification in SAM.gov, to include the completed provision at FAR 52.204-26 Covered Telecommunications Equipment or Services-Representation, dated October 2020.

5. **Quoters must complete (or attach) the pricing tables in section 1.5 of this RFQ; and, section 1.4 of attachment 1 Delivery Order One Statement of Need (SON).

6. A technical description of the items/services being offered in sufficient detail to evaluate compliance with the requirements in the solicitation. This may include product literature, or other documents, if necessary.

Note: It is the Quoter’s responsibility to read the RFQ and all related documents carefully.

Additionally, it is the Quoter’s responsibility to ensure/verify the Government receives its submission on or before the date/time specified above. The Government reserves the right to not accept any late quotes, any quote that does not provide items/services requested, or quotes that do not conform to the requirements of the RFQ.

BASIS FOR AWARD AND EVALUATION

A single IDIQ award shall be made to the firm that submits a technically acceptable quotation at the lowest price. A technically acceptable quote is one in which the quoter(s) complies with the Statement of Need (SON) and does not take exception, nor object to any of the terms of the RFQ.

Quotes that are not technically acceptable will not be eligible for award. The award will be made on an all-or-none basis.