RFQ 11239790 S.pdf

Date: August 11, 2021

From: Janae Hughes, Contract Specialist, Facilities Support Branch, OAGS

Subject: Request for Quote

Identification Number: 75F40121Q00058

NAICS Code: 334516

BRAND NAME OR EQUAL

TOTAL SMALL BUSINESS SET-ASIDE

This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. The incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2021-06.

THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE

SOLICITATION WILL NOT BE ISSUED.

The request for quotes (RFQ) number for this acquisition is 75F40121Q00058. This will be awarded as a Firm-Fixed Price Purchase Order and 100% Total Small Business Set-Aside. The Government reserves the right to award an order without discussions if the Contracting Officer determines that the initial offer is providing best value and discussions are not necessary.

The Government intends to award a Firm Fixed-Price Order for the requirements described in line items number (LIN) 1-4.

A. STATEMENT OF WORK (SOW) -- SCOPE OF WORK

The U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) seeks to procure a FIA-Lab ProSIA-Glycan Profiling Sample Pretreatment Module or BRAND NAME EQUIVALENT for the automation of the Waters GlycoWorks or equivalent derivatization method to support on-line glycan analysis of biotherapeutic protein isolated from crude bioreactor media in real-time and the development of PAT instrumentation for a base-period and three (1) year option periods described in LIN’s 1-4. The Vendor shall indicate if the minimum salient characteristics have been met to be considered responsive for this requirement.

B. TECHNICAL REQUIREMENTS

1. Applications

a. Sequential injection analysis system designed for automation of glycan analysis of crude bioreactor media which can be integrated in an online fashion with FDA’s on-line sampling system (Flownamics) software version 5.1.8 and FDA’s Waters UPLC for glycan quantification and feedback control implementation of the bioreactors for Sartorius MFCS software version 3 level 34.

b. Injection analyzer shall be benchtop sized no larger than (16”x12”x10”).

c. Injection analyzer and software shall allow for manual injections for controls, as the flow-path from the autosampler/bioreactor under a continuous monitoring setup will not allow manual injection of control solutions otherwise.

d. Final injection volume shall be at least 250 µL to be compatible with the Waters UPLC.

e. Integration with the Waters UPLC shall be through Empower 3 FR4 and corresponding Ole for Process Control (OPC) client.

2. Components

a. ProSIA System. Dual Syringe Sequential Injection Analysis system.

3. Shall operate on a 110-240 V line

4. Accessories, training, and warranty

a. Proposal should include all necessary starter kits, capillaries, and reagents necessary.

i) Upgrade selector valve to 12-port option

ii) Injection volume ranges from a minimum of 1 µL to 500 µL.

iii) Syringe pump with 9-way valve to accommodate a wide range of mixing volumes: from

20 µL to 500 µL. The syringe pump shall be able to pull sample from the previous instrument (Flownamics Segflow). The pump shall flush between mixing steps.

iv) Laptop with software installed

v) High precision Flow through Heater 120V (capable of maintaining at least 90°C)

vi) Heater block, for stainless or Teflon tubing (capable of maintaining at least 90°C)

vii) Heater block, for columns (capable of maintaining at least 90°C)

viii) Chiller setup, dry bath, screw down type, for FIAlab setups for extending the lifetime of temperature-sensitive reagents

ix) Valve: 10-port selector, high-speed, Valcon E2 rotor. For selecting sample source.

x) ADU2018-FLANGE – USB I/O interface, flange mount. Relay I/O unit for HPLC injection control.

xi) Degasser

xii) Physical and software integration of injection analyzer, Waters Empower 3 FR4, Flownamics software version 5.1.8, and Sartorius MFCS version 3 level 34 to enable automated feed-back loops for control between the proposed liquid handler, Autosampler, UPLC and Bioreactor.

xiii) Design and construction of desiccation trap to physically accommodate Waters GlycoWorks or equivalent glycan analysis method and extend lifetime of reagents.

b. Installation and Operational qualification

c. On-site training and installation should be included in price

i) Installation shall include setting up machine and performing installation and operational qualification.

ii) Training to include On-site application training or no more than 3 days

d. Warranty should cover all parts and installation for at least 1 year.

5. Shipping- The vendor shall provide shipping, handling and inside delivery to the delivery location in section.

6. Preventative Maintenance Plan for 3 years total coverage PM plan shall provide:

1. Extension of warranty on non-consumable parts for 1 year to 3 years

2. Two service visits

3. Free software upgrades

4. Phone, e-mail and remote desktop support

A. Unlimited technical support, Mondays – Fridays (excluding Federal Holidays) between the hours of 8:00 AM – 5:00 PM Central Time, within 8 business hours of contact for assistance (e.g., telephone-based, email-based, website-based, etc.)

B. Maintenance and repair activities shall be performed by formally trained and certified technicians/engineers, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using new OEM replacement parts, components, subassemblies, etc.

C. Pricing shall be inclusive of labor, travel, replacement parts, components, subassemblies, etc.

D. Deliverables: Service Records and Reports

i. The Contractor shall, commensurate with the completion of each service call or preventative maintenance visit, provide the end-user of the equipment and the Project Officer with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced.

C. PERIOD OF PERFORMANCE

Base Period: August 20, 2021 – August 19, 2023 Option Period 1: August 20, 2023 – August 19, 2024 Option Period 2: August 20, 2024 – August 19, 2025 Option Period 3: August 20, 2025 – August 19, 2026

D. PLACE OF PERFORMANCE

FOB: Destination 10903 New Hampshire Ave Building 52/72 Silver Spring, MD 20993

E. LINE ITEM AND PRICES

All charges shall be included in the quote.

LIN DESCRIPTION QTY PRICE

1 FIA-Lab ProSIA-Glycan Profiling Sample Pretreatment Module & Warranty Period of Performance: 8/20/2021-8/19/2023

1 EA $

2 Option Period 1: Preventative Maintenance - FIA-Lab ProSIA-Glycan Profiling Sample Pretreatment Module Period of Performance: 8/20/2023-8/19/2024

1 EA $

3 Option Period 2: Preventative Maintenance -FIA-Lab ProSIA-Glycan Profiling Sample Pretreatment Module Period of Performance: 8/20/2024-8/19/2025

1 EA $

4 Option Period 3: Preventative Maintenance -FIA-Lab ProSIA-Glycan Profiling Sample Pretreatment Module Period of Performance: 8/20/2025-8/19/2026

1 EA $

TOTAL = $

F. GOVERNMENT HOLIDAYS

a. The Government hereby provides notification that Government personnel observe the listed days as holidays:

(1) New Year’s Day (6) Labor Day

(2) Martin Luther King’s Birthday (7) Columbus Day

(3) President’s Day (8) Veterans’ Day

(4) Memorial Day

A. Juneteenth National Independence Day Observance

(9) Thanksgiving Day

(5) Independence Day (10) Christmas Day

b. In addition to the days designated as holidays, the Government observes the following days:

(1) Any other day designated by Federal Statute

(2) Any other day designated by Executive Order

(3) Any other day designated by the President’s Proclamation

c. When any such day falls on a Saturday, the following Monday is observed. Except for designated around-the-clock or emergency operations, Contractor personnel will not be able to perform on-site under this contract with FDA on holidays set forth above. The Contractor will not charge any holiday as direct charge to the award.

d. It is understood and agreed between the Government and the Contractor that observance of such days by Government personnel shall not otherwise be a reason for an additional period of performance, or entitlement of compensation except as set forth within the award.

e. Nothing in this clause abrogates the rights and responsibilities of the parties relating to stop work provisions as cited in other sections of this contract.

F. EVALUATION AND AWARD

Lowest Priced, Technically Acceptable (LPTA). FDA will first evaluate all Offerors’ prices, then, evaluate the apparent lowest-priced quote/proposal for acceptability under the technical and past performance factors (if applicable). If the lowest-price Offeror was evaluated as unacceptable, FDA would then consider the acceptability of the next lowest-price Offeror, continuing this process as necessary.

INSTRUCTIONS TO OFFEROR FOR PROPOSAL SUBMISSION

FAR 52.212-1 Instructions to Offerors—Commercial Items (JUL 202)

PROPOSAL SUBMISSION FORMAT

***Proposal shall be in 2 volumes: 1 Technical and 2 Price. The volumes shall be separate and complete. The volumes shall be separate and complete, so that evaluation of one may be accomplished independently of, and concurrently with, the evaluation of the other. No pricing information shall be provided in volume 1.*** The total number of pages for the technical quote shall not exceed fifteen (15) pages, using 1” margins, single spaced, font type Time New Roman, and a font size of 12.

***The solicitation does not commit the Government to pay any cost for the preparation and submission of a quote or proposal. It is also advised that the Contracting Officer (CO) is the only individual who can legally commit and obligate the Government to the expenditure of public funds in connection with the proposed acquisition.***

QUESTIONS DEADLINE: Interested offerors shall submit questions electronically to janae.hughes@fda.hhs.gov no later than August 13, 2021, 12:00 PM Eastern Time. Please include the company name, FDA solicitation number, and “Question(s)” in the subject line.

No Phone Calls Please.

PROPOSAL DUE: All proposals are due, electronically to contract specialist email:

Janae.hughes@fda.hhs.gov for the RFQ no later than August 17, 2021, 12:00 PM Eastern Time.

G. PROVISIONS AND CLAUSES:

FAR 52.212-4 - Contract Terms and Conditions – Commercial – Items (Oct 2018).

FAR 52.252‐2 Solicitation Provisions 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/far and https://www.acquisition.gov/hhsar.

The Following Provisions and clauses apply:

HHSAR Clauses 352.222‐70 Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015) FAR Clauses FAR 52.212‐2 Evaluation‐Commercial Items (OCT 2014) FAR 52.212‐3, Offeror Representations and Certifications‐Commercial Items (Mar 2020) FAR 52.212‐4 Contract Terms and Conditions‐Commercial Items (Oct 2018) FAR 52.212‐5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders‐Commercial Items (Nov 2020)

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

(2) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(3) 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:

mailto:janae.hughes@gmail.com mailto:Janae.hughes@fda.hhs.gov https://www.acquisition.gov/far https://www.acquisition.gov/hhsar

[Contracting Officer check as appropriate.]

(1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

(2) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509)).

(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.)

_x_ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2016) (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. (Oct 2015) (31 U.S.C. 6101 note).

(9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41 U.S.C. 2313).

(10) [Reserved].

(11)(i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C.

657a).

(ii) Alternate I (Nov 2011) of 52.219-3.

(12)(i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C.

657a).

(ii) Alternate I (JAN 2011) of 52.219-4.

(13) [Reserved] _x_ (14)(i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011) (15 U.S.C.

644).

(ii) Alternate I (Nov 2011).

(iii) Alternate II (Nov 2011).

(15)(i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C.

644).

(ii) Alternate I (Oct 1995) of 52.219-7.

(iii) Alternate II (Mar 2004) of 52.219-7.

(16) 52.219-8, Utilization of Small Business Concerns (Nov 2016) (15 U.S.C.

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

(17)(i) 52.219-9, Small Business Subcontracting Plan (Nov 2016) (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 (Nov 2016) of 52.219-9.

(v) Alternate IV (Nov 2016) of 52.219-9.

(18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)).

(19) 52.219-14, Limitations on Subcontracting (Jan 2017) (15 U.S.C. 637(a)(14)).

(20) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C.

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

(21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set- Aside (Nov 2011) (15 U.S.C. 657 f).

x (22) 52.219-28, Post Award Small Business Program Re-representation (Jul 2013) (15 U.S.C. 632(a)(2)).

(23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-Owned Small Business Concerns (Dec 2015) (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 (Dec 2015) (15 U.S.C. 637(m)).

_x_ (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

_x_ (26) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Oct 2016) (E.O.

13126).

_x_ (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

_x_ (28) 52.222-26, Equal Opportunity (Sept 2016) (E.O. 11246).

(29) 52.222-35, Equal Opportunity for Veterans (Oct 2015)(38 U.S.C. 4212).

_x_ (30) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

(31) 52.222-37, Employment Reports on Veterans (FEB 2016) (38 U.S.C. 4212).

_x_ (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496).

_x_ (33)(i) 52.222-50, Combating Trafficking in Persons (Mar 2015) (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).

(34) 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.)

(35) 52.222-59, Compliance with Labor Laws (Executive Order 13673) (OCT 2016). (Applies at $50 million for solicitations and resultant contracts issued from October 25, 2016 through April 24, 2017; applies at $500,000 for solicitations and resultant contracts issued after April 24, 2017).

Note to paragraph (b)(35): By a court order issued on October 24, 2016, 52.222-59 is enjoined indefinitely as of the date of the order. The enjoined paragraph will become effective immediately if the court terminates the injunction. At that time, GSA, DoD and NASA will publish a document in the Federal Register advising the public of the termination of the injunction.

(36) 52.222-60, Paycheck Transparency (Executive Order 13673) (OCT 2016).

(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 (Jun 2014) of 52.223-14.

(42) 52.223-15, Energy Efficiency in Energy-Consuming Products (DEC 2007) (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 (AUG 2011) (E.O. 13513).

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

(46) 52.223-21, Foams (JUN 2016) (E.O. 13693).

(47) 52.225-1, Buy American—Supplies (May 2014) (41 U.S.C. chapter 83).

(48)(i) 52.225-3, Buy American—Free Trade Agreements—Israeli Trade Act (May 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.

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

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

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

(49) 52.225-5, Trade Agreements (OCT 2016) (19 U.S.C. 2501, et seq., 19 U.S.C.

3301 note).

_x_ (50) 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

(51) 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).

(52) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

(53) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150).

(54) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C.

4505, 10 U.S.C. 2307(f)).

(55) 52.232-30, Installment Payments for Commercial Items (Jan 2017) (41 U.S.C.

4505, 10 U.S.C. 2307(f)).

_x_ (56) 52.232-33, Payment by Electronic Funds Transfer—System for Award Management (Jul 2013) (31 U.S.C. 3332).

(57) 52.232-34, Payment by Electronic Funds Transfer—Other than System for Award Management (Jul 2013) (31 U.S.C. 3332).

(58) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

(59) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

(60)(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.

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

[Contracting Officer check as appropriate.]

(1) 52.222-17, Non-displacement of Qualified Workers (May 2014)(E.O. 13495).

(2) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67).

(3) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

(4) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple Year and Option Contracts) (May 2014) (29 U.S.C. 206 and 41 U.S.C.

chapter 67).

(5) 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).

(6) 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).

(7) 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).

(8) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).

(9) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O.

13706).

(10) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (May 2014) (42 U.S.C. 1792).

(11) 52.237-11, Accepting and Dispensing of $1 Coin (Sept 2008) (31 U.S.C.

5112(p)(1)).

(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.

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

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

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

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C.

3509).

(ii) 52.219-8, Utilization of Small Business Concerns (Nov 2016) (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 shall include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(iii) 52.222-17, Non-displacement of Qualified Workers (May 2014) (E.O. 13495). Flow down required in accordance with paragraph (l) of FAR clause 52.222-17.

(iv) 52.222-21, Prohibition of Segregated Facilities (Apr 2015) (v) 52.222-26, Equal Opportunity (Sept 2016) (E.O. 11246).

(vi) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).

(vii) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

(viii) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212)

(ix) 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.

(x) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67). (xi) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O 13627).

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

(xii) 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).

(xiii) 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).

(xiv) 52.222-54, Employment Eligibility Verification (OCT 2015) (E.O. 12989).

(xv) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).

(xvi) 52.222-59, Compliance with Labor Laws (Executive Order 13673) (OCT 2016) (Applies at $50 million for solicitations and resultant contracts issued from October 25, 2016 through April 24, 2017; applies at $500,000 for solicitations and resultant contracts issued after April 24, 2017).

Note to paragraph (e)(1)(xvi): By a court order issued on October 24, 2016, 52.222-59 is enjoined indefinitely as of the date of the order. The enjoined paragraph will become effective immediately if the court terminates the injunction. At that time, GSA, DoD and NASA will publish a document in the Federal Register advising the public of the termination of the injunction.

(xvii) 52.222-60, Paycheck Transparency (Executive Order 13673) (OCT 2016)).

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

(xix) 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).

(xx) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (May 2014) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xxi) 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.

52.217-5 Evaluation of Options (Jul 1990) Except when it is determined in accordance with FAR 17.206(b) not to be in the Government’s best interests, the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. Evaluation of options will not obligate the Government to exercise the option(s).

52.217-8 Option to Extend Services. (Nov 1999) The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor any time before the contract expires.

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 any time before the contract expires; provided that the Government gives the Contractor a preliminary written notice of its intent to extend 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 4 years.

FDA Invoice Submission Instructions FDA Three-Way Match Invoicing Procedures

A. The contractor shall submit all invoices to:

U.S. FOOD AND DRUG ADMINISTRATION

Attn: Vendor Payments Division of Payment Services 10903 New Hampshire Ave WO32 ‐ Second Floor

MAIL HUB 2145

Silver Spring, MD 20993‐0002

(301) 827‐3742 E‐mail: FDAVendorPaymentsTeam@fda.gov *** Acceptable methods of delivery include: E‐mail (preferred) and Standard Mail. Provide a copy marked courtesy to the Contracting Officer Representative (COR) identified above.

B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232‐25 (Prompt Payment) and 52.232‐33 (Payment by Electronic Funds Transfer – System for Award Management) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(i) Name and address of the contractor;

(ii) Invoice date and invoice number;

(iii) Contract/Order number (including a reference to any base award for Indefinite‐ Delivery/Indefinite‐Quantity Contracts or Blanket Purchase Agreements);

(iv) Description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including:

(a) period of performance for which costs are claimed;

(b) itemized travel costs, including origin and destination;

(c) any other supporting information necessary to clarify questionable expenditures;

(d) the contractor shall include the Contract Line Item/Funding line item for each description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading;

(vi) Terms of any discount for prompt payment offered (Prompt Payment terms other than NET 30);

(vii) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment)

(viii) Name, title, and phone number of person to notify in event of defective invoice;

(ix) Taxpayer Identification Number (TIN);

(x) Electronic funds transfer (EFT) banking information, including routing transit number of the financial institution receiving payment;

(xi) Name and telephone number of the FDA Contracting Officer Representative (COR) or other Program Center/Office point of contact, as referenced on the award;

(xii) For all Time‐and‐Materials and Labor‐Hour Awards, Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) list of all invoices submitted to date under the subject award, including the following:

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

(b) total amount of all payments received to date under the subject contract or order

(c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance;

(xiii) Any other information or documentation required by the award.

C. An electronic invoice is acceptable if submitted in adobe acrobat (PDF) format. All items listed in (i) through (xii) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

D. Questions regarding invoice payments should be directed to the Employee Resource and Information Center (ERIC) Helpdesk at 301‐827‐ERIC (3742) or toll‐free 866‐807‐ERIC (3742);

or, by email at ERIC@fda.hhs.gov. Refer to the Call‐in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received.

When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.