HQ034-17-R-0037-_Immoussary_Reagent_Kits_RFP.pdf

HQ003417R0037

Section B - Supplies or Services and Prices

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 Kit Immunoassay Reagents Kits

FFP

The contractor shall provide support In accordance with the Performance Work

Statement dated: March 1, 2017.

PURCHASE REQUEST NUMBER: PLL010420171126

NET AMT

0002 Lot Other Direct Costs (ODC)

COST

All itmes shipped via FedEx. Shipping costs are determined based on weight, dimenson and destination

PURCHASE REQUEST NUMBER: PLL010420171126

ESTIMATED COST

1001 Kit OPTION Immunoassay Reagents Kits

FFP

The contractor shall provide support In accordance with the Performance Work

1002 Lot OPTION Other Direct Costs (ODC)

COST

All itmes shipped via FedEx. Shipping costs are determined based on weight, 2001 Kit OPTION Immunoassay Reagents Kits

FFP

2002 Lot OPTION Other Direct Costs (ODC)

COST

3001 Kit OPTION Immunoassay Reagents Kits

FFP

3002 Lot OPTION Other Direct Costs (ODC)

COST

4001 Kit OPTION Immunoassay Reagents Kits

FFP

4002 Lot OPTION Other Direct Costs (ODC)

COST

CONTRACT MINIMUM/MAXIMUM QUANTITY AND CONTRACT VALUE

The minimum quantity and contract value for all orders issued against this contract shall not be less than the minimum quantity and contract value stated in the following table. The maximum quantity and contract value for all orders issued against this contract shall not exceed the maximum quantity and contract value stated in the following table.

MINIMUM

QUANTITY

MINIMUM

AMOUNT

MAXIMUM

QUANTITY

MAXIMUM

AMOUNT

0.00 $500.00 0.00 $16,500,000.00

DELIVERY/TASK ORDER MINIMUM/MAXIMUM QUANTITY AND ORDER VALUE

The minimum quantity and order value for each Delivery/Task Order issued shall not be less than the minimum quantity and order value stated in the following table. The maximum quantity and order value for each

Delivery/Task Order issued shall not exceed the maximum quantity and order value stated in the following table.

QUANTITY

MINIMUM

AMOUNT

MAXIMUM

QUANTITY

MAXIMUM

0.00 $1.00 0.00 $3,500,000.00

CLIN DELIVERY/TASK ORDER MINIMUM/MAXIMUM QUANTITY AND CLIN ORDER VALUE

The minimum quantity and order value for the given Delivery/Task Order issued for this CLIN shall not be less than the minimum quantity and order value stated in the following table. The maximum quantity and order value for the given Delivery/Task Order issued for this CLIN shall not exceed the maximum quantity and order value stated in the following table.

CLIN

QUANTITY

MINIMUM

AMOUNT

MAXIMUM

QUANTITY

MAXIMUM

Section C - Descriptions and Specifications

SOW

STATEMENT OF WORK

SYNTHETIC CANNABINOIDS SCREENING REAGENT

March 1, 2017

1. GENERAL REQUIREMENTS FOR AN IMMUNOASSAY TEST REAGENT FOR THE DETECTION

OF SYNTHETIC CANNABINOIDS AND CROSS-REACTIVE SYNTHETIC CANNABINOID

METABOLITES IN URINE

1.1. Overview. The materials shall be provided as a homogenous immunoassay reagent for use in the initial screening test for the detection of synthetic cannabinoid (SYCAN) metabolites excreted in the urine from a broad spectrum of (SYCAN) compounds found in the drug culture. The reagent shall be compatible with the Beckman

Coulter AU5800 series clinical chemistry analyzer systems in use at the Department of Defense (DoD) Forensic

Toxicology Drug Testing Laboratories (FTDTLs), and shall be compatible without modification of the instruments.

The reagent shall be compatible with the optimal throughput of the analyzer systems and shall not interfere with the optimum performance of the other immunoassay procedures conducted on these instruments. The reagent shall not impose additional maintenance or servicing requirements for the optimum performance of the contractor’s reagent on the analyzer. When using the offeror’s recommended calibrator, the reagent must be capable for the

Government’s use of a offeror’s calibrator at a cutoff concentration of 10 ng/mL. The reagent should demonstrate calibration stability, as evaluated by a low frequency of control failures, and should require approximately one initial calibration during an 8 hour period. The reagent shall maintain reproducibility in quality control (QC) and quality assurance (QA) measurements within batch and between batch assays (200 specimens and controls per batch) over the course of an 8 hour period.

1.2. Sensitivity and Specificity. The reagent shall be used for the detection of various SYCAN metabolites excreted in urine resulting from a broad spectrum of SYCAN compounds found in the drug culture.

The reagent must be a single homogeneous immunoassay reagent system that will be evaluated on the capable of detecting the urine metabolites of JWH-018, JWH-073, UR-144, MAM-2201, 5F-PB-22, AB-

CHMINACA, AB-PINACA, and AB-FUBINACA.

Using the offeror’s recommended calibrator at the DoD cutoff concentration of 10 ng/mL, if the various cross reactive urine metabolites associated with individual SYCAN compounds in Section 1.1.1. exceed a cumulative concentration equal to or greater than 10ng/mL, a positive response should be anticipated.

The reagent shall have minimum cross-reactivity with drugs or drug metabolites currently on the DoD

Drug Test Panel cited below. The following initial immunoassay screen cutoffs concentrations (ng/mL) are used for other compounds on the DoD drug test panel.

o 11-nor-delta-9-THC-carboxylic acid (THC) 50 ng/mL;

o Benzoylecgonine (BZE) 150 ng/mL;

o morphine (MOR) 300 ng/mL;

o codeine (COD) 300 ng/mL;

o 6-acetylmorphine (6AM) 10 ng/mL;

o hydrocodone (HYDC) 300 ng/mL;

o hydromorphone (HYDM) 300 ng/mL;

o oxycodone (OXYC) 100 ng/mL;

o oxymorphone (OXYM) 100 ng/mL;

o d-amphetamine (AMP) 500 ng/mL;

o d-methamphetamine (MET) 500 ng/mL;

o methylenedioxymethamphetamine (MDMA) 500 ng/mL;

o methylenedioxyamphetamine (MDA) 500 ng/mL;

o benzodiazepines (BZD) nordiazepam (NORD) 200 ng/mL;

oxazepam (OXAZ) 200 ng/mL;

alpha hydroxy-alprazolam (AHAL) 200 ng/mL;;

lorazepam (LORA) 200 ng/mL;;

temazepam (TEMA) 200 ng/mL;

1.2.1. Specificity. The testing reagent shall be evaluated for its ability to detect specimens contain SYCAN metabolites of whose parent SYCAN compound is of interest to the DoD Drug Demand Reduction Program

(DDRP) of drug deterrence and detection. The SYCAN compounds whose metabolites are of greatest interest in the

DDRP are grouped as Tier One or Tier Two SYCANs. The Tier One SYCANs contains SYCAN compounds whose urine metabolites are most frequently encountered in the drug testing program. The Tier Two SYCANs contains

SYCAN compounds for which DoD has developed confirmatory liquid chromatography tandem mass spectrometry

(LC/MS/MS) procedures to quantify a specific urine metabolite of the SYCAN compound.

Tier One SYCANs o JWH-018 o JWH-073

Tier Two SYCANs o XLR-11 o UR-144 o MAM-2201 o 5F-PB22 o AB-CHMINACA o AB-PINACA o AB-FUBINACA

1.2.1.1 Immunoassay Specificity and LC/MS/MS Confirmatory Analysis. A specimen deemed positive above the immunoassay screen 10 ng/mL cutoff concentration will be evaluated by LC/MS/MS quantitative analysis for the following specific SYCAN urinary metabolite. Specimens that confirm for the presence of the following specific metabolite(s) at or above a 1.0 ng/mL LC/MS/MS cutoff concentration will be considered positive for the presence of the SYCAN compound(s) by immunoassay and LC/MS/MS testing methodologies

Tier One SYCAN Metabolites:

o JWH-018-N-5-pentanoic acid metabolite o JWH-073-N-4-butanoic acid metabolite

Tier Two SYCAN Metabolites:

o UR-144-N-5-pentanoic acid metabolite o AB-CHIMINACA (metabolite 4) [1-(cyclohexylmethyl)-1H-indazole-3-carboxylic acid] o 5-fluoro-PB22-3-carboxyindole metabolite o MAM-2201 N-pentanoic acid metabolite o AB-PINACA-pentanoic acid [5-(3-((1-amino-3-methyl-a-oxobutan-2-yl)carbamoyl0-1H-indazol-

1-yl)-pentanoic acid] o AB-FUBINACA (metabolite 2) [4-amino-3-(1-(4-fluorobenzyl0-1H-indazole-3-coboxamido)-2-methyl-4-oxobutanoic acid]

1.3. Compliance with Good Manufacturing Practices. In general, immunoassay kits are usually considered medical devices. As such, the manufacturer shall adhere to good manufacturing processes (GMP) in the manufacture of the immunoassay kits and its components, independent of Food and Drug Administration (FDA) market clearance status. Any health related issue, product performance, safety problem, or any other mandatory recall action related to the immunoassay kits provided under the resulting contract shall require notification to the

Contracting Officer within two working days of awareness or notification of the event.

1.4. Packaging. The materials provided shall be packaged in volumes convenient for refrigerated storage and applicable to the sample throughput at the military laboratories, and shall not result in the loss or unnecessary disposal of more than 3% of the working volume of reagent. Any individual bottle of reagent which would be prepared for use at one time shall not include materials for more than 5,000 tests. The contractor will not be required to provide calibrators and control materials for the drug reagent. (The military laboratories will separately obtain or provide calibrators and control materials to be used with the reagent.) The materials shall be provided with an instruction sheet that includes all requirements for instrument operation parameters, reagent preparation and storage, and shall include data demonstrating specific reagent performance characteristics, such as accuracy, precision, sensitivity, specificity, cross-reactivity with various SYCAN metabolites, and applicable safety precautions.

1.5. Shelf Life. Minimum shelf life of any unopened component of the assay shall be at least 180 days from date of delivery to the drug testing laboratory. Once kit container seals are broken and the components are opened, the shelf-life shall be at least 14 days. Once diluted, the material shall have a shelf life of at least 24 hours.

2.0. TESTING AND QUALITY CONTROL PROTOCOL

2.1. Instrument Calibration. The following testing and quality control protocol shall be used for testing. The reagents supplied shall be adaptable to the calibration requirements and characteristics of the Beckman Coulter

AU5800 series clinical chemistry analyzer system. Using the offeror’s recommended calibrator at the DoD 10 ng/mL cutoff concentration, verification of calibration shall be evaluated using: a drug free control, and the offerors recommended cutoff calibrator at target concentrations of 50%, 150%, and 200% of the 10 ng/mL DoD calibrator cutoff concentration. Open and blind quality control urine specimens shall be randomly distributed throughout a test batch of approximately 200 specimens.

3. PERFORMANCE TESTING FACTORS.

3.1. Sensitivity to Specific SYCAN Metabolites. Relative to the offeror’s calibrator at a 10 ng/mL concentration, the percent cross-reactivity of the individual SYCAN metabolite cited in section 1.2.1.1 will be evaluated at various concentrations. Higher cross-reactivity to the individual metabolites in section 1.2.1.1 at or above 100% is favored as well as the number of individual metabolites in section 1.2.1.1. with a cross-reactivity above 50% and 25% will be evaluated.

3.2. SYCAN Positive Specimens. When using the offeror’s recommended calibrator, the reagent will be evaluated for the ability to identify the presence of various metabolites of individual SYCAN compounds cited in section

1.1.1. when the cumulative concentration of a individual SYCAN compound is equal to or greater than the DoD 10 ng/mL cutoff concentration. Performance of the offeror’s reagent will be determined in analysis of archived specimens reported positive for the presence of SYCAN metabolites identified in Section 1.2.1.1 Differences between offerors’ screening performance will be evaluated by LC/MS/MS for the presence of SYCAN specific metabolites cited in section 1.2.1.1. at or above the LC/MS/MS cutoff concentration of 1.0 ng/mL.

3.3. SYCAN Negative Specimens. When using the offeror’s recommended calibrator, the reagent must be capable of identifying specimens as negative for the presence of various SYCAN metabolite(s) in physiological urine when present in human urine at concentration below the DoD 10 ng/mL cutoff concentration. Performance of the offeror’s reagent will be determined in a side by side comparison of the offeror’s reagent to the current immunoassay utilized in the military laboratories. Differences in performance will be evaluated by LC/MS/MS for the absence of SYCAN specific metabolites cited in section 1.2.1.1. below the LC/MS/MS cutoff concentration of

1.0 ng/mL.

3.4. False Positive Screen. When using the offeror’s calibrator, the reagent must minimize the number of "false positive" specimens that screen positive at or above the DoD 10 ng/mL cutoff concentration; but, fail to confirm by

LC/MS/MS at or above the DoD 1.0 ng/mL cutoff concentration for any of the specific SYCAN metabolites cited in section 1.2.1.1.. The percent “false positive” is [1 – (the number of specimens confirmed positive for the presence of a section 1.2.1.1. metabolite divided by the number of specimens sent for confirmation analysis)] times 100.

3.4.1. False Negative Screen. When using the offeror’s calibrator, the reagent must minimize the number of "false negative" specimens that screen negative below the DoD 10 ng/mL cutoff concentration; but, upon LC/MS/MS analysis, any of the specific SYCAN metabolites cited in section 1.2.1.1. if detected at or above the DoD 1.0 ng/mL cutoff concentration. The percent “false negative” is [1- (number of specimens confirmed positive for the presence of a section 1.2.1.1 metabolite divided by the actual number of specimens positive for the presence of a section

1.2.1.1. metabolite)] times 100.

3.5. Confirmation Rates of Screen Positive Specimens. When using the offeror’s calibrator, the offeror’s reagent shall be evaluated in terms of confirmation rate relative to screen positive rate (the number of specimens confirmed positive for a specific SYCAN metabolite cited in section 1.2.1.1 by LC/MS/MS at 1.0 ng/mL divided by the number of specimens screened positive at 10 ng/mL x 100). A higher percent confirmation rate will be considered a better value than a lower percent confirmation rate.

3.6. Solicitation Minimum Requirements. The reagent must be capable of meeting the Minimum Requirements established in Evaluation Factor C: Performance Test – Minimum Requirements. Data obtained during the

Performance Test will be analyzed to determine the reagent’s ability to meet the solicitation Minimum

Requirements.

3.7. Enhancing Factors. If the reagent meets all Minimum Requirements in Evaluation Factor C, data obtained during the Performance Test will be analyzed to determine the reagent’s increased or decreased value based on its ability to meet the Evaluation Factors D: Performance Test – Enhancing Factors.

4. OFFEROR’S QUALITY ASSURANCE PROGRAM – OFFEROR’S SHALL POSSESS CURRENT ISO-

9000 SERIES CERTIFICATION OR INCLUDE DOCUMENTATION OF THE FOLLOWING

ELEMENTS:

4.1. Chemicals and Reagents

4.1.1. Quality and Authenticity. All materials used in the preparation of reagents shall be verified as to authenticity and purity. Methods may include, but are not limited to, the determination of melting points, LC/MS/MS, Nuclear Magnetic Resonance (NMR), and spectrophotometric measurements.

4.1.2. Stability. The kit and each kit component shall be shown to be stable and at the correct concentration over the period of use of the kit. Components that are homogeneous solutions shall not deteriorate throughout the period of use of the kit (from date of preparation to date of expiration).

4.2. Manufacturer’s Equipment.

4.2.1. Preventive Maintenance. Routine preventive maintenance procedures, periodic calibration, and any unscheduled maintenance shall be fully documented and in accordance with recommendations of the manufacturer of the equipment.

4.2.2. Calibration and Operational Checks. All instruments that are used to check a physical parameter of a solution or material shall be calibrated and have documentation available to demonstrate that all required operational checks have been completed. This includes pH meters, spectrometers, micropipettes, etc.

4.2.3. Temperature Checks. Water baths, refrigerators, freezers, and other equipment that is intended to maintain a given temperature shall be periodically validated for accuracy and routinely verified for correct settings.

4.2.4. Glassware and Other Reusable Laboratory Supplies. Appropriate procedures for cleaning and inspecting glassware and other reusable materials shall be established and compliance documented.

4.3. Antibody Drug Molecule(s).

4.3.1. Authenticity. The prepared antibody drug molecule(s) shall be verified to be authentic and its purity established.

4.3.2. Stability. The antibody drug shall be documented to be stable to the expiration date and the immunoassay shall meet all contract specifications to the end of expiration date (which is 180 days minimum).

4.4. Antibody Specificity. Antibody specificity shall be verified for each lot and the specificity re-evaluated at routine intervals to ensure uniformity and quality of preparations. The offeror shall provide performance characteristics in terms of sensitivity and specificity for detection of various SYCAN metabolites as may be applicable to the SYCANs listed is section

4.5. Immunoassays.

4.5.1. Technical Performance. Performance of each lot of kits shall be verified. The verification shall establish, as a minimum, the appropriate response to the target molecule and that all other parameters as specified in the contract are met.

4.5.2. Stability. The performance parameters involved in the testing procedures shall be verified and documented to be consistent throughout the shelf life of the kit.

4.5.3. Manufacturer's Production Manual. Procedures and criteria required to validate all components (and materials) employed during the manufacture of the reagents in the test kits and the operation of the completed kit over the entire period of shelf-life of the kit shall be described in detail. All steps of each quality control procedure shall be described thoroughly.

4.5.4. Records. The production and quality assurance records generated by each procedure performed above shall be maintained in a systematic fashion to permit the verification of completion of all production parameters and shall be available for inspection during the term of the contract.

4.5.5. Corrective Action(s). When a specified quality control parameter is found to be out of limits, the action(s) taken to ensure correction for existing kits (i.e., notification) shall be documented and action taken to ensure that the deficiency does not reoccur and all records shall be retained. The Contracting Officer shall be notified within 2 working days of any deficiencies in existing kits and of all corrective actions for consideration, i.e., delivery of replacement kits at no cost to the Government. As may be required, the FDA shall be notified according to its regulations.

4.5.6. Lot Numbers. Lot numbers shall be used to identify reagent and other preparations to allow tracking of all immunoassay components. The procedures used to assign unique lot numbers for each solution or reagent shall be described. A single lot number for a kit shall suffice if all materials used in that lot number can be tracked to identify the materials and procedures used in the preparation of that kit.

Section E - Inspection and Acceptance

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

0001 Destination Government Destination Government

0002 Destination Government Destination Government

1001 Destination Government Destination Government

1002 Destination Government Destination Government

2001 Destination Government Destination Government

2002 Destination Government Destination Government

3001 Destination Government Destination Government

3002 Destination Government Destination Government

4001 Destination Government Destination Government

4002 Destination Government Destination Government

Section F - Deliveries or Performance

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

0001 POP 29-MAY-2017 TO

28-MAY-2018

N/A OUSD PERSONNEL & READINESS

THOMAS MARTIN

4000 DEFENSE PENTAGON RM 1E537

WASHINGTON DC 20301

(210) 221-7256

FOB: Destination

HQ0061

0002 POP 29-MAY-2017 TO

28-MAY-2018

N/A (SAME AS PREVIOUS LOCATION)

1001 POP 29-MAY-2018 TO

28-MAY-2019

N/A (SAME AS PREVIOUS LOCATION)

1002 POP 29-MAY-2018 TO

28-MAY-2019

N/A (SAME AS PREVIOUS LOCATION)

2001 POP 29-MAY-2019 TO

28-MAY-2020

N/A (SAME AS PREVIOUS LOCATION)

2002 POP 29-MAY-2019 TO

28-MAY-2020

N/A (SAME AS PREVIOUS LOCATION)

3001 POP 29-MAY-2020 TO

28-MAY-2021

N/A (SAME AS PREVIOUS LOCATION)

3002 POP 29-MAY-2020 TO

28-MAY-2021

N/A (SAME AS PREVIOUS LOCATION)

4001 POP 29-MAY-2021 TO

28-MAY-2022

N/A (SAME AS PREVIOUS LOCATION)

4002 POP 29-MAY-2021 TO

28-MAY-2022

N/A (SAME AS PREVIOUS LOCATION)

Section G - Contract Administration Data

CLAUSES INCORPORATED BY FULL TEXT

2-1252.232-7006 WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (MAY 2013)

(a) Definitions. As used in this clause--

Department of Defense Activity Address Code (DoDAAC) is a six position code that uniquely identifies a unit, activity, or organization.

Document type means the type of payment request or receiving report available for creation in Wide Area

WorkFlow (WAWF).

Local processing office (LPO) is the office responsible for payment certification when payment certification is done external to the entitlement system.

(b) Electronic invoicing. The WAWF system is the method to electronically process vendor payment requests and receiving reports, as authorized by DFARS 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports.

(c) WAWF access. To access WAWF, the Contractor shall--

(1) Have a designated electronic business point of contact in the System for Award Management at https://www.acquisition.gov; and

(2) Be registered to use WAWF at https://wawf.eb.mil/ following the step-by-step procedures for self-registration available at this Web site.

(d) WAWF training. The Contractor should follow the training instructions of the WAWF Web-Based Training

Course and use the Practice Training Site before submitting payment requests through

WAWF. Both can be accessed by selecting the “Web Based Training” link on the WAWF home page at https://wawf.eb.mil/.

(e) WAWF methods of document submission. Document submissions may be via Web entry, Electronic Data

Interchange, or File Transfer Protocol.

(f) WAWF payment instructions. The Contractor must use the following information when submitting payment requests and receiving reports in WAWF for this contract/order:

(1) Document type. The Contractor shall use the following document type(s).

Combo

(2) Inspection/acceptance location. The Contractor shall select the following inspection/acceptance location(s) in

WAWF, as specified by the contracting officer.

Inspection: HQ0061

Acceptance: HQ0061

(3) Document routing. The Contractor shall use the information in the Routing Data Table below only to fill in applicable fields in WAWF when creating payment requests and receiving reports in the system.

Routing Data Table*

Field Name in WAWF Data to be entered in WAWF

Pay Official DoDAAC HQ0347

Issue By DoDAAC HQ0034

Admin DoDAAC HQ0034

Inspect By DoDAAC HQ0061

Ship To Code HQ0061

Ship From Code N/A

Mark For Code N/A

Service Approver (DoDAAC) HQ0061

Service Acceptor (DoDAAC) HQ0061

Accept at Other DoDAAC N/A

LPO DoDAAC N/A

DCAA Auditor DoDAAC N/A

Other DoDAAC(s) N/A

(4) Payment request and supporting documentation. The Contractor shall ensure a payment request includes appropriate contract line item and subline item descriptions of the work performed or supplies delivered, unit price/cost per unit, fee (if applicable), and all relevant back-up documentation, as defined in DFARS Appendix F, (e.g. timesheets) in support of each payment request.

(5) WAWF email notifications. The Contractor shall enter the email address identified below in the “Send

Additional Email Notifications” field of WAWF once a document is submitted in the system.

TO BE DETERMINED

(g) WAWF point of contact. (1) The Contractor may obtain clarification regarding invoicing in WAWF from the following contracting activity's WAWF point of contact.

TO BE DETERMINED

(2) For technical WAWF help, contact the WAWF helpdesk at 866-618-5988.

(End of clause)

Section I - Contract Clauses

CLAUSES INCORPORATED BY REFERENCE

52.204-7 System for Award Management OCT 2016

52.204-9 Personal Identity Verification of Contractor Personnel JAN 2011

52.204-10 Reporting Executive Compensation and First-Tier

Subcontract Awards

OCT 2016

52.204-13 System for Award Management Maintenance OCT 2016

52.204-19 Incorporation by Reference of Representations and

Certifications.

DEC 2014

52.209-6 Protecting the Government's Interest When Subcontracting

With Contractors Debarred, Suspended, or Proposed for

Debarment

OCT 2015

52.209-9 Updates of Publicly Available Information Regarding

Responsibility Matters

JUL 2013

52.209-10 Prohibition on Contracting With Inverted Domestic

Corporations

NOV 2015

52.212-4 Contract Terms and Conditions--Commercial Items MAY 2015

52.223-18 Encouraging Contractor Policies To Ban Text Messaging

While Driving

AUG 2011

52.225-13 Restrictions on Certain Foreign Purchases JUN 2008

52.233-3 Protest After Award AUG 1996

52.233-4 Applicable Law for Breach of Contract Claim OCT 2004

252.203-7000 Requirements Relating to Compensation of Former DoD

Officials

SEP 2011

252.203-7002 Requirement to Inform Employees of Whistleblower Rights SEP 2013

252.203-7003 Agency Office of the Inspector General DEC 2012

252.203-7004 Display of Hotline Posters OCT 2016

252.203-7005 Representation Relating to Compensation of Former DoD

Officials

NOV 2011

252.204-7000 Disclosure Of Information OCT 2016

252.204-7003 Control Of Government Personnel Work Product APR 1992

252.204-7006 Billing Instructions OCT 2005

252.204-7011 Alternative Line Item Structure SEP 2011

252.204-7012 Safeguarding Covered Defense Information and Cyber

Incident Reporting

OCT 2016

252.204-7015 Notice of Authorized Disclosure of Information for Litigation

Support

MAY 2016

252.209-7004 Subcontracting With Firms That Are Owned or Controlled By

The Government of a Country that is a State Sponsor of

Terrorism

OCT 2015

252.216-7009 Allowability of Legal Costs Incurred in Connection With a

Whistleblower Proceeding

SEP 2013

252.222-7007 Representation Regarding Combating Trafficking in Persons JAN 2015

252.225-7048 Export-Controlled Items JUN 2013

252.232-7003 Electronic Submission of Payment Requests and Receiving

Reports

JUN 2012

252.232-7010 Levies on Contract Payments DEC 2006

252.237-7010 Prohibition on Interrogation of Detainees by Contractor

Personnel

JUN 2013

252.243-7001 Pricing Of Contract Modifications DEC 1991

252.243-7002 Requests for Equitable Adjustment DEC 2012

252.244-7000 Subcontracts for Commercial Items JUN 2013

252.247-7023 Transportation of Supplies by Sea APR 2014

CLAUSES INCORPORATED BY FULL TEXT

52.203-18 PROHIBITION ON CONTRACTING WITH ENTITIES THAT REQUIRE CERTAIN INTERNAL

CONFIDENTIALITY AGREEMENTS OR STATEMENTS--REPRESENTATION (JAN 2017)

(a) Definition. As used in this provision--

Internal confidentiality agreement or statement, subcontract, and subcontractor, are defined in the clause at 52.203-

19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements.

(b) In accordance with 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), Government agencies are not permitted to use funds appropriated (or otherwise made available) for contracts with an entity that requires employees or subcontractors of such entity seeking to report waste, fraud, or abuse to sign internal confidentiality agreements or statements prohibiting or otherwise restricting such employees or subcontractors from lawfully reporting such waste, fraud, or abuse to a designated investigative or law enforcement representative of a Federal department or agency authorized to receive such information.

(c) The prohibition in paragraph (b) of this provision does not contravene requirements applicable to Standard Form

312, (Classified Information Nondisclosure Agreement), Form 4414 (Sensitive Compartmented Information

Nondisclosure Agreement), or any other form issued by a Federal department or agency governing the nondisclosure of classified information.

(d) Representation. By submission of its offer, the Offeror represents that it will not require its employees or subcontractors to sign or comply with internal confidentiality agreements or statements prohibiting or otherwise restricting such employees or subcontractors from lawfully reporting waste, fraud, or abuse related to the performance of a Government contract to a designated investigative or law enforcement representative of a Federal department or agency authorized to receive such information (e.g., agency Office of the Inspector General).

(End of provision)

52.211-16 VARIATION IN QUANTITY (APR 1984)

(a) A variation in the quantity of any item called for by this contract will not be accepted unless the variation has been caused by conditions of loading, shipping, or packing, or allowances in manufacturing processes, and then only to the extent, if any, specified in paragraph (b) below.

(b) The permissible variation shall be limited to:

10 Percent increase

10 Percent decrease

This increase or decrease shall apply to each quantity specified in the delivery schedule.

52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR

EXECUTIVE ORDERS—COMMERCIAL ITEMS (DEVIATION 2013-O0019) (NOV 2016)

(a) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph

(a) 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.

(b)

(1) Notwithstanding the requirements of any other clause in this contract, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (b)(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 (Oct 2014) (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 $650,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(iii) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495). Flow down required in accordance with paragraph (1) of FAR clause 52.222-17.

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

(v) 52.222-26, Equal Opportunity (Sep 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) X (A) 52.222-50, Combating Trafficking in Persons (Mar 2015) (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 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).

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

Per Court Injunction dated 24 Oct 2016 and OMB memo dated 25 Oct 2016 do not implement the following until further direction.

(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).

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

(xviii) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section

862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

(xix) 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.

(xx) 52.247-64, Preference for Privately-Owned U.S. Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

(2) While not required, the contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.

(End of Clause)

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 $500.00, 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 $3,500,000.00;

(2) Any order for a combination of items in excess of $16,500.00; or

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

(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) above.

(d) Notwithstanding paragraphs (b) and (c) above, 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 3 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.

52.216-22 INDEFINITE QUANTITY. (OCT 1995)

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

(b) Delivery or performance 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 or services 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 30 days.

52.217-6 OPTION FOR INCREASED QUANTITY (MAR 1989)

The Government may increase the quantity of supplies called for in the Schedule at the unit price specified. The

Contracting Officer may exercise the option by written notice to the Contractor within 15 days.. Delivery of the added items shall continue at the same rate as the like items called for under the contract, unless the parties otherwise agree.

52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 10 days;

provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 15days 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 60

Months

52.232-18 AVAILABILITY OF FUNDS (APR 1984)

Funds are not presently available for this contract. The Government's obligation under this contract is contingent upon the availability of appropriated funds from which payment for contract purposes can be made. No legal liability on the part of the Government for any payment may arise until funds are made available to the Contracting

Officer for this contract and until the Contractor receives notice of such availability, to be confirmed in writing by the Contracting Officer.

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):

http://farsite.hill.af.mil/

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):

52.252-5 AUTHORIZED DEVIATIONS IN PROVISIONS (APR 1984)

(a) The use in this solicitation of any Federal Acquisition Regulation (48 CFR Chapter 1) provision with an authorized deviation is indicated by the addition of"(DEVIATION)" after the date of the provision.

(b) The use in this solicitation of Defense Federal Acquisition Regulations (48 CFR Chapter 2) provision with an authorized deviation is indicated by the addition of "(DEVIATION)" after the name of the regulation.

52.252-6 AUTHORIZED DEVIATIONS IN CLAUSES (APR 1984)

(a) The use in this solicitation or contract of any Federal Acquisition Regulation (48 CFR Chapter 1) clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the date of the clause.

(b) The use in this solicitation or contract of any Defense Federal Acquisition Regulations (48 CFR Chapter 2) clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the name of the regulation.

252.201-9000 WHS/AD LOCAL CLAUSE: CONTRACTING OFFICER’S REPRESENTATIVE (COR)

(MAR 2015)

(a) The Contracting Officer’s Representative (COR) is a representative of the Government with limited authority who has been designated in writing by the Contracting Officer to provide technical direction, clarification, and guidance with respect to existing specifications and performance work statement/statement of work/statement of objectives, as established in the contract. The COR also monitors the progress and quality of the Contractor’s performance for payment purposes. The COR shall promptly report Contractor performance discrepancies and suggested corrective actions to the Contracting Officer for resolution.

(b) The COR is not authorized to take any direct or indirect actions or make any commitments that will result in changes to price, quantity, quality, schedule, place of performance, delivery or any other terms or conditions of the written contract.

(c) The Contractor is responsible for promptly providing written notification to the Contracting Officer if it believes the COR has requested or directed any change to the existing contract. No action shall be taken by the Contractor for any proposed change to the existing contract. No action shall be taken by the Contractor for any proposed change to the contract until the Contracting Officer has issued a written directive or a written modification to the contract. The

Government will not accept and is not liable for any alleged change to the contract unless the change is included in a written contract modification or directive signed by the Contracting Officer.

(d) COR authority is not delegable.

(e) The COR for this contract is: To Be Determined

(end of clause)

252.203-7996 PROHIBITION ON CONTRACTING WITH ENTITIES THAT REQUIRE CERTAIN INTERNAL

CONFIDENTIALITY AGREEMENTS—REPRESENTATION (DEVIATION 2016-O0003)(OCT 2015)

(a) In accordance with section 101(a) of the Continuing Appropriations Act, 2016 (Pub. L. 114-53) and any subsequent FY 2016 appropriations act that extends to FY 2016 funds the same restrictions as are contained in section 743 of division E, title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L.

113-235), none of the funds appropriated (or otherwise made available) by this or any other Act may be used for a contract with an entity that requires employees or subcontractors of such entity seeking to report fraud, waste, or abuse to sign internal confidentiality agreements or statements prohibiting or otherwise restricting such employees or contactors from lawfully reporting such waste, fraud, or abuse to a designated investigative or law enforcement representative of a Federal department or agency authorized to receive such information.

(b) The prohibition in paragraph (a) of this provision does not contravene requirements applicable to Standard Form

312, Form 4414, or any other form issued by a Federal department or agency governing the nondisclosure of classified information.

(c) Representation. By submission of its offer, the Offeror represents that it does not require employees or subcontractors of such entity seeking to report fraud, waste, or abuse to sign or comply with internal confidentiality agreements or statements prohibiting or otherwise restricting such employees or contactors from lawfully reporting such waste, fraud, or abuse to a designated investigative or law enforcement representative of a Federal department or agency authorized to receive such information.

252.216-7006 ORDERING (MAY 2011)

(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 contract schedule. Such orders may be issued from May

29, 2017 through May 28, 2022.

(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)(1) If issued electronically, the order is considered ``issued'' when a copy has been posted to the Electronic

Document Access system, and notice has been sent to the Contractor.

(2) If mailed or transmitted by facsimile, a delivery order or task order is considered ``issued'' when the Government deposits the order in the mail or transmits by facsimile. Mailing includes transmittal by U.S. mail or private delivery services.

(3) Orders may be issued orally only if authorized in the schedule.

(End of Clause)

252.232-7003 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS AND RECEIVING REPORTS

(JUNE 2012)

(a) Definitions. As used in this clause–

(1) Contract financing payment and invoice payment have the meanings given in section 32.001 of the Federal

Acquisition Regulation.

(2) Electronic form means any automated system that transmits information electronically from the initiating system to all affected systems. Facsimile, e-mail, and scanned documents are not acceptable electronic forms for submission of payment requests. However, scanned documents are acceptable when they are part of a submission of a payment request made using Wide Area WorkFlow (WAWF) or another electronic form authorized by the Contracting

Officer.

(3) Payment request means any request for contract financing payment or invoice payment submitted by the

Contractor under this contract.

(4) Receiving report means the data required by the clause at 252.246-7000, Material Inspection and Receiving

Report.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests and receiving reports using WAWF, in one of the following electronic formats that WAWF accepts: Electronic Data Interchange, Secure File Transfer Protocol, or World Wide Web input. Information regarding WAWF is available on the Internet at https://wawf.eb.mil/.

(c) The Contractor may submit a payment request and receiving report using other than WAWF only when–

(1) The Contracting Officer administering the contract for payment has determined, in writing, that electronic submission would be unduly burdensome to the Contractor. In such cases, the Contractor shall include a copy of the

Contracting Officer's determination with each request for payment;

(2) DoD makes payment for commercial transportation services provided under a Government rate tender or a contract for transportation services using a DoD-approved electronic third party payment system or other exempted vendor payment/invoicing system (e.g., PowerTrack, Transportation Financial Management System, and Cargo and

Billing System);

(3) DoD makes payment for rendered health care services using the TRICARE Encounter Data System (TEDS) as the electronic format; or

(4) When the Governmentwide commercial purchase card is used as the method of payment, only submission of the receiving report in electronic form is required.

(d) The Contractor shall submit any non-electronic payment requests using the method or methods specified in

Section G of the contract.

(e) In addition to the requirements of this clause, the Contractor shall meet the requirements of the appropriate payment clauses in this contract when submitting payments requests.

252.233-9000 WHS/AD LOCAL PROVISION: AGENCY-LEVEL PROTESTS (MAR 2015)

Potential bidders or offerors may submit an agency-level protest directly to the Contracting Officer. As an alternative to the Contracting Officer’s consideration of a protest, a potential bidder or offeror may request an independent review of their protest by a WHS Protest Deciding Official. In either case, the agency-level protest must comply with the requirements and procedures in FAR 33.103 for submitting agency-level protests. A request for an independent review by the WHS Protest Deciding Official shall be submitted to: David D. Sanders, 1225 S. Clark

Street, Suite 1202, Arlington, VA 22202, david.d.sanders6.civ@mail.mil. A protest decision by the Contracting

Officer or WHS Protest Deciding Official is final and not subject to appeal or reconsideration within WHS.

(end of clause)

Section J - List of Documents, Exhibits and Other Attachments

Exhibit/Attachment Table of Contents

DOCUMENT TYPE DESCRIPTION PAGES DATE

Attachment 1 Price Template 1 31-MAR-2017

Section L - Instructions, Conditions and Notices to Bidders

INSTRUCTIONS TO QUOTERS

Offeror shall submit their Proposal with the following documentation:

(1) In order to maximize efficiency and minimize the effort involved in the Offeror evaluation process, all

Offeror must comply with the following instructions for Offeror format, content, including applicable page limitations.