2015-306_Solicitation_Bioanalysis_Testing_Servcies.pdf

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

1. REQUISITION NUMBER PAGE 1 OF

2. CONTRACT NO. 3. AWARD/EFFECTIVE

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7. FOR SOLICITATION

INFORMATION CALL:

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8. OFFER DUE DATE/

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9. ISSUED BY

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14. METHOD OF SOLICITATION

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15. DELIVER TO 16. ADMINISTERED BY CODE

18a. PAYMENT WILL BE MADE BY CODE17a. CONTRACTOR/

OFFEROR

CODE

FACILITY

CODE

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TELEPHONE NO.

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN

OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK

BELOW IS CHECKED

RFQ IFB RFP

SEE ADDENDUM

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ITEM NO.

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SCHEDULE OF SUPPLIES/SERVICES

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QUANTITY

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UNIT

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UNIT PRICE

24.

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

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DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

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DATED . . YOUR OFFER ON SOLICITATION

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SET FORTH HEREIN, IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR

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TION UNLESS BLOCK IS

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SEE SCHEDULE

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ARE ARE NOT ATTACHED

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27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

8 (A)

EDWOSB

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SMALL BUSINESS

NIDA SSSA-SOL-2015-306

Debra C. Hawkins 301-594-2178

Bio-analysis Testing Services

Continuation SF1449 Solicitation / Contract / Order For Commercial Items, 12 pages

FAR Clause 52.212-4 Contract Terms and Conditions - Commercial Items, 18 pages

08/03/2015

09/04/2015

3:00 PM EST

HHS, NIH, National Institute on Drug Abuse Station Support Contracts and Simplified Acquisition Branch Bethesda, Maryland 20892

STANDARD FORM 1449 (REV. 2/2012) BACK

19.

ITEM NO.

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SCHEDULE OF SUPPLIES/SERVICES

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QUANTITY

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UNIT

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UNIT PRICE

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AMOUNT

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

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41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER 41c. DATE

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40. PAID BY

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REPRESENTATIVE

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32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

33. SHIP NUMBER 34. VOUCHER NUMBER 35. AMOUNT VERIFIED

CORRECT FOR

PARTIAL FINAL

37. CHECK NUMBER

38. S/R ACCOUNT NO. 39. S/R VOUCHER NUMBER

36. PAYMENT

COMPLETE PARTIAL FINAL

Addendum, FAR Clause 52.212-4 Contract Terms and Conditions - Commercial Items, 6 pages

FAR Clause 52.212-5 Contract terms and Conditions Required to Implement Status or Executive Orders

- Commercial Items, 8 pages

Attachment, Invoice and Payment Provisions, 3 pages

FAR Clause 52.212-1 Instructions to Offerors - Commercial Items, 4 pages

Addendum, FAR Clause 52.212-1 Instructions to Offerors - Commercial Items, 41 pages

FAR Clause 52.212-2 Evaluation - Commercial Items, 1 pages

FAR Clause 52.212-3 Offeror Representations and Certifications-Commercial Items, 19 pages

Solicitation Number: HHS-NIH-NIDA-SSSA-SOL-2015-306 Continuation, SF 1449—Solicitation/Contract/Order for Commercial Items

Continuation, SF 1449, Block 20 – SCHEDULE OF SUPPLIES / SERVICES

BLOCK 20. ITEM 1, GENERAL

a. Independently and not as an agent of the government the contractor shall provide a broad range of bioanalysis testing services as described herein.

b. This is a Multiple Award Indefinite Delivery/Indefinite Quantity contract as contemplated by FAR 16.504, utilizing Fixed Price Delivery Orders. The contract will be used solely by the National Center for Advancing Translational Sciences (NCATS).

c. This contract is a partial small business set-aside in which 50% of the awards are reserved for small businesses. In addition, small businesses will receive priority consideration for award of each delivery order. The small business set-aside priority does not preclude other than (large or foreign) small businesses from submitting quotes on any delivery order.

d. The choice of which contractor to use for an individual action will be at the discretion of the NCATS Contracting Officer’s Representative (COR) and the Contracting Officer (C) in accordance with the procedures delineated in FAR 16.505(b), which will be used to determine the best interest of the government, all factors, including price considered.

BLOCK 20. ITEM 2, PRICES

a. The Contractor shall be reimbursed by the Government through individual delivery orders in an amount not less than the minimum obligation amount of $150.00 (equivalent to one sample or specimen) and no more than the total estimated maximum amount of $20,000,000.00 for successful performance through the entire term of the contract.

b. The base period of performance of this contract consists of a period of five (5) years from September 15, 2015 through September 14, 2020.

c. Upon delivery and acceptance of the Bioanalysis Testing Services described herein, payments will be made for each delivery order issued on a fixed price basis at the prices set forth in the contractor’s published commercial price list, less the negotiated percentage discount.

d. The Government will compete and award Delivery Orders on an as needed basis for the Bioanalysis Testing Services described below. Ordering procedures are described in Block 20.

Item 7—Delivery Order Procedures of this contract.

BIOANALYSIS TESTING SERVICES

Item No.

Category Descriptions

1. Chemistry Services

Synthetic Organic Chemistry

Bioorganic Chemistry

High‐throughput (Hit‐to‐Lead & Lead Optimization) Chemistry

Medicinal Chemistry

Computational Chemistry / Cheminformatics

No.

Category Descriptions

Analytical Chemistry / Separations

2. Process Development and Manufacturing Services

Process Discovery and Development

Solid State Identification and Characterization

Pilot Production and Manufacturing

Analytical / QC

Pre‐Formulation and Formulation

Kilo Scale Production

3. Biology Services

Assay Development

Compound Screening

Cell‐Based Assays

PD/Biomarkers

Bioreagents and Structural Biology

In vitro Toxicity

Compound Management

4. DMPK (Drug Metabolism Pharmacokinetics) Services

In vitro ADME (Absorption, distribution, metabolism, excretion) Services

Solution Properties

Drug Absorption & Transport

Drug Metabolism

Metabolite Profiling, Identification, Screening

Drug‐Drug Interactions

In vivo PK / Bioanalytical Capability

In vivo PK / Bioanalytical Services

In vivo PK/ Techniques

PK for Biologics

5. In vivo Pharmacology Services

Oncology

Central Nervous System

Inflammation and Pain

Metabolic Diseases

In Vivo Technologies

Ex vivo Pharmacology

6. Good Laboratory Practice (GLP) / Good Clinical Practice (GCP) Bioanalytical Services

Pharmacokinetic (PK) and pharmacodynamic (PD) testing

Bioanalytical method development and validation

No.

Category Descriptions

Homogeneity and stability testing in dose formulations

Pharmacokinetics sample (PK) analysis

Toxicokinetics (TK) analysis

Clinical sample analysis

PK/TK modeling

7. Good Laboratory Practice (GLP) Toxicology and Safety Pharmacology Services

General Toxicology

Safety Pharmacology

Immunology

8. High Throughput Chemical Analysis

Quality Management Plan LC/MS/CLND/ELSD/UV Analysis and Data Review GC/MS Analysis GC/MS Sample Drying Study High Field NMR Analysis

BLOCK 20. ITEM 3, STATEMENT OF WORK

A. Background Information

The National Center for Advancing Translational Sciences (NCATS) is the newest of 27 Institutes and Centers (ICs) at the National Institutes of Health (NIH). This Center was established in December 2011 to transform the translational science process so that new treatments and cures for disease can be delivered to patients faster.

The mission of the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH) is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions.

The National Institutes of Health (NIH) Chemical Genomics Center (NCGC) in the National Center for Advancing Translational Sciences (NCATS) is a translational science center that prides itself on its tremendously productive pipeline and is innovative in mays ways. Our quantitative high throughput screening (qHTS) paradigm, focus on collaboration with outside investigators to produce high-quality chemical probes to define new biology, and its unique focus on new technologies and paradigms to improve the process of probe development are a few of the many examples that accelerates and innovates NCGC research.

In particular, the medicinal chemistry component of NCATS is responsible for synthesizing small molecules that are potent and specific against the target of interest. Once attractive small molecules have been identified through our translational research, medicinal chemists rely on in vitro ADME and pharmacokinetics to better predict and understand the potential disposition within an organism. Importantly, any small molecule could in the future be considered as a potential pharmaceutical agent and such data is needed for effective triaging and characterization.

Furthermore, in order to continue NCATS’ impressive publication portfolio which includes around 100 publications annually in many peer reviewed journal, including high impact publication, such data is needed.

B. Purpose or Objective of the Requirement

The purpose of this requirement is to purchase commercially available bioanalytical testing services which are required in support of the on-going research of the NCATS NCGC.

C. Scope of Work

The work scope is provided in general terms to purchase bioanalysis testing services of the government’s furnished materials in support of its research. The Contractor has maximum flexibility to devise the best method to accomplish the required services.

The contractor shall provide bioanalysis testing services to the NCATS/NCGC on an as needed basis.

The contractor shall perform bioanalysis testing services of the government’s samples in support of the research conducted at NCATS/NCGC. Specifically, the contractor shall perform bioanalysis testing services on the government furnished small molecules and samples and provide a report to the government of the results of the services.

The bioanalysis testing services must be commercially available, include all services detailed in the contractor’s commercially available price list, and must provide a reasonable delivery period of the analysis results after receipt of the delivery order.

D. Contractor Requirements The contractor shall perform bioanalysis testing services on an as needed basis as requested by individual delivery order to the National Center for Translational Sciences (NCATS) National Institutes of Health Chemical Genomics Center (NCGC).

At a minimum the bioanalysis testing services shall include but not limited to:

The ability to choose between single point and a time course.

A choice between human, monkey, dog, rat, mouse, gerbil, rabbit, and bovine. The tests are needed to gain an understanding of how the small molecule retains its quality over the course of administration and the parameter reported is frequently half-life (T1/2).

Human and non-human hepatocyte stability and clearance because most drugs are eliminated from the body by hepatic metabolism and the prediction of in vivo clearance (CL) from in vitro systems which plays an important role in the drug discovery process.

Stability in simulated gastrointestinal fluid, intestional fluid, blood and plasma. These will be determined either as % remaining at a particular time point or T1/2 (time course).

Stability in liver microsomes and/or liver S9 fractions in the presence of NADPH (Phase I metabolism) and/or NADPH/UDPGA (Phase I/II metabolism).

Plasma protein binding and MDCK permeability testing, as well as P-gp substrate assays, including +/- GF120918, in MDCK-MDR1 and MDCK, and in Caco-2, and a P-gp inhibition assay service.

Cytochrome 450 testing. CYP450 metabolize thousands of endogenous and exogenous chemicals and hence are the major enzyme involved in drug metabolism. NCGC needs a contractor to offer CYP450 testing is required across many isoforms such as 1A2, 2B6, 2C8, 2C9, 2C19, 2D6, and 3A4. The resulting parameter is most frequently an IC50

Analyte detection and concentration determinations for specific projects. The samples will be sent from NCATS to the contractor who will be responsible for detecting the specific analyte as established beforehand.

In vitro toxicology studies: including mitochondrial toxicity, hERG inhibition using automated patch clamp, cell viability endpoints, genotoxicity (e.g. Ames Test, in vitro Comet or in vitro micronucleus), reactive metabolite detection using trapping agents, drug-induced phospholipidosis

PXR activation: Activation of PXR represents an important mechanism for the induction of cytochrome P450 3A (CYP3A) enzymes Therefore, activation of PXR plays a major role in increased Drug-Drug interactions. The resulting parameter is most frequently an

EC50

Polymorphic and non-CYP mediated metabolism: including monoamine oxidase, caroxylesterasse and aldehyde oxidase inhibition and reaction phenotyping

In vivo DMPK (rodent and non-rodent): Formulation of small molecule agent, Pharmacokinetics (IV/IP/PO), Efficacy models, PK/PD, with robust bioanalytical characterization of selected analytes.

Determination of purity and concentration by GC/MS analysis using various drying methods on low concentration DMSO solutions containing absorbed water.

Identification, purity and quantification of low concentration samples in a DMSO solution by high field NMR (600 MHz).

E. Government Responsibilities The Government will:

1. Provide small molecules and samples to the contractor, on an as needed per order basis.

2. Review the bioanalysis results, and provide an electronic receipt and acceptance acknowledgement to the contractor within seven (7) calendar days.

3. Enter receiving authorization in the NIH receiving system in an accurate and timely manner.

F. Deliverable Requirements The contractor shall submit to the government the following deliverables:

1. Bioanalysis Testing Services Results

2. Contractor’s Published Commercial Price List

3. Delivery Order Report

Timely submission of deliverables is essential to the successful completion of the contract. All deliverables shall be prepared and submitted according to format, content, and schedule as described herein.

G. Other Considerations

1. Data Rights NCATS NCGC shall have unlimited rights to and ownership of all deliverables provided under this contract, including reports, recommendations, briefings, work plans and all other deliverables. This includes the deliverables provided under the basic contract and any optional task deliverables exercised by the contracting officer. In addition, it includes any additional deliverables required by contract change. The definition of “unlimited rights” is contained in Federal Acquisition Regulation (FAR) 27.401, “Definitions.” FAR clause 52.227-14, “Rights in Data-General” is hereby incorporated by reference and made a part of this contract/order.

2. Section 508—Electronic and Information Technology Standards

The contractor shall comply with Section 508 of the Rehabilitation Act (29 U.S.C. § 794d), as amended by the Workforce Investment Act of 1998 (P.L. 105-220), August 7, 1998.

BLOCK 20. ITEM 4, REPORTING REQUIREMENTS

a. The contractor shall submit to the government the following reports electronically in the format and content as specified below:

(1) Bioanalysis Testing Services Results Report. This report shall be submitted within 3 business days upon completion of the bioanalysis testing services. The report shall be in Excel or word format specifying the (1) study name; (2) bioanalysis testing service category; (3) bioanalysis testing service description; (4) process description; and (5) results.

(2) Delivery Order Report. The delivery order report must include: (1) name of the NCATS requesting official; (2) name of the NCATS ordering official; (3) delivery order number; (4) delivery date; (5) itemized list of testing services ordered; (6) commercial price; (7) negotiated percentage discount;(8) total amount of invoice; and (9) total amount of delivery order. The report is due on or before the 15th calendar day of each month covering the deliveries completed during the previous month. The report must be submitted in an Excel Spreadsheet format.

(3) Contractor’s Published Commercial Price List. The contractor is required to submit its most current published commercial price list annually in accordance with deliverable schedule.

b. The NCATS Ordering Official shall review the Delivery Order Report within 7 business days upon receipt and within 15 business days after receipt follow-up with contractor any discrepancies identified on the Delivery Order Report.

c. All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at:

http://www.hhs.gov/web/508/index.html under "Making Files Accessible."

d. All paper/hardcopy documents/reports submitted under this contract shall be printed or copied, double-sided, on at least 30 percent post-consumer fiber paper, whenever practicable, in accordance with FAR 4.302(b).

BLOCK 20. ITEM 5, DELIVERABLES SCHEDULE

No.

Description Delivery Date Delivery Point

1. Bioanalysis Testing Services Results

To be determined after submission of government materials for testing

To be specified upon submission of government materials for testing

2. Bioanalysis Testing Services Commercial Price List

Annually, August 14, 2016, 2017, 2018, 2019, and 2020

NCATS Ordering Officer Contracting Officer’s Representative (COR) Contracting Officer (CO)

3. Delivery Order Report Monthly on or before the 15th calendar day of each month

COR

CO

BLOCK 20. ITEM 6, PACKAGING, MARKING AND SHIPPING

Packaging, marking, and shipping instructions to be specified in the individual delivery order

BLOCK 20. ITEM 7, DELIVERY ORDER PROCEDURES

a. General

(1) This is a fixed price, indefinite delivery—indefinite quantity type contract for the National Center for Advancing Translational Science (NCATS) to purchase commercially available bioanalysis testing services on an as needed basis.

(2) Any bioanalysis testing services to be furnished under this contract shall be ordered by issuance of a Delivery Order (OD) by an authorized Contracting Officer during the period September 15, 2015 through September 14, 2020.

(3) All DOs are subject to the terms and conditions of this contract. In the event of conflict between a DO and this contract, the contract shall control.

(4) The minimum order amount of each DO is $150.00 which is equivalent to one (1) sample or specimen.

(5) The maximum order amount of all DOs shall not exceed the total estimated value of the contract.

(6) Only the National Institute on Drug Abuse (NIDA) Consolidated Operations Acquisition

Center (COAC) Contract Specialist (CS) / Contracting Officer (CO) may issue DOs to the Contractor, providing specific authorization or direction to perform work within the scope of the contract as specified in the Statement of Work.

(7) Unless specifically authorized by the NIDA COAC CS/CO, the Contractor shall not commence work until a fully executed Delivery Order has been awarded and submitted to the Contractor.

(8) The NIDA COAC CS/CO shall include both the Contract Number and the Delivery

Order Number to the contractor at the time the order is placed. The Contractor shall not accept an order without the Contract Number and the Delivery Order Number.

(9) The Contractor may incur costs under this contract in performance of DOs issued in accordance with this contract. No other costs are authorized unless otherwise specified in the contract or expressly authorized by the NIDA COAC CS/CO.

(10) The NCATS Ordering Official is responsible for ensuring that at no time will the individual orders exceed the dollars obligated by the Delivery Order.

(11) The NCATS Ordering Official must promptly notify the NIDA COAC CS/CO and Technical

Project Officer when orders have reached the Delivery Order obligation and/or when monies will need to be de-obligated due to low spending levels.

(12) The following NCATS Ordering Official(s) are authorized issue request for delivery order price quotes (RFQ) under this contract.

Name Telephone Number Email Address

b. Evaluation and Award of Delivery Order Quotes The Government will evaluate the Delivery Order (DO) quotes against the requirements of the DO Request for Quote (RFQ). Specifically, the technical evaluation factors and cost/price will be used for evaluation of each quote. In addition, the DO RFQ will identify the basis for selecting a contractor for award. Generally, technical factors will be significantly more important than cost or price. However, each DO RFQ will specify how the award decision will be made.

c. Ordering Procedures

(1) When NCATS Requester/End-User-Scientist determines a need exists for bioanalysis testing services, a request for delivery order price quote (RFQ) should prepare the RFQ and submit to the designated NCATS Ordering Official(s).

(2) The Delivery Order RFQ must include:

(i) Generic name of the testing services (e.g. Chemistry Services— Synthetic Organic Chemistry; Biology Services—Assay Development, Biology Services— Compound Development, etc.);

(ii) Study name and specification of the services to be performed;

(iii) Quantity;

(iv) Unit of Issue;

(v) Price quote due date (allow 1 to 5 days for receipt of quote);

(vi) Government’s desired delivery date; and

(vii) Requester/End-user/Scientist name, telephone number, and email address

(3) The designated NCATS Ordering Official(s) shall submit the RFQ electronically to all bioanalysis testing services contract awardees.

(4) Upon receipt, the designated NCATS Ordering Official will review the quote(s) and forward to the Requester/End-User-Scientist for their review, approval, and award recommendation.

(5) The Requester/End-User-Scientist will submit the evaluation of the quotes and award recommendation to the NCATS Ordering Official.

(6) The NCATS Ordering Official will verify funds availability and submit the quotes, the evaluation, and the award recommendation to the NIDA COAC Contract Specialist / Contracting Officer.

(7) The NIDA COAC Contract Specialist / Contracting Officer will review the quotes, the evaluation, the award recommendation, and verify funds availability. The NIDA COAC Contract Specialist / Contracting Officer will approve the award recommendation and issue the delivery order electronically to the successful contract awardee.

d. Contractor Procedures

(1) The Contractor shall confirm receipt of the Delivery Order within twenty-four (24) hours of receipt to the NIDA COAC CS/CO and the NCATS Ordering Official.

(2) The Contractor shall not exceed the Delivery Order award (OF 347 dollars) amount without prior written approval of the NIDA COAC CS/CO by modification of the Delivery Order.

(3) The Contractor shall provide a packing slip or other evidence of delivery/performance for each Delivery Order

(4) The Contractor shall submit the reports and deliverables in a timely manner as specified herein.

(5) The contractor shall submit proper invoice after receipt and acceptance of each of the individual delivery order.

(6) The following Contractor representative(s) is/are authorized to receive and accept orders placed by telephone:

Name Telephone Number Email Address

e. Fair Opportunity

(1) In accordance with FAR 16.505(b)(1)(i), each contractor under the multiple award bioanalysis testing services awardees will be given a fair opportunity to be considered for each order issued over $3,000 unless the following exception(s) apply:

(i) The agency need for the supplies or services is so urgent that providing a fair opportunity would result in unacceptable delays.

(ii) Only one contract holder is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized.

(iii) The order must be issued on a sole-source basis in the interest of economy and efficiency because it is a logical follow-on to an order already issued under the contract, provided that all awardees were given a fair opportunity to be considered for the original order.

(iv) It is necessary to place an order to satisfy a minimum guarantee.

(2) All contract holders will be given a fair opportunity to be considered in accordance with the Federal Acquisition Regulations (FAR) as follows:

(i) For orders exceeding $3,000 up to the simplified acquisition threshold, in accordance with FAR 16.505(b)(1)(ii);

(ii) For orders exceeding the simplified acquisition threshold up to $5 Million, in accordance with 16.505(b)(1)(iii); and,

(iii) For orders exceeding $5 Million, in accordance with FAR 16.505(b)(1)(iv).

BLOCK 20. ITEM 8. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a. Contractor Performance Evaluations

Interim and final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart 42.15. The final performance evaluation will be prepared at the time of completion of work. In addition to the final evaluation prepared on September 15, 2020 and annually on September 15, 2016, 2017, 2018, and 2019.

Interim and final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final.

Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

b. Electronic Access to Contractor Performance Evaluations

Contractors may access evaluations through a secure Web site for review and comment at the following address: https://www.cpars.csd.disa.mil

BLOCK 20. ITEM 9. SUBCONTRACTING PROVISIONS

NOTE: Subcontracting provisions are applicable to other than small socio-economic business concerns under the NAICS code for this requirement.

1. Small Business Subcontracting Plan The failure of any Contractor or subcontractor to comply in good faith with FAR Clause 52.219-8, entitled "Utilization of Small Business Concerns" incorporated in this contract and the attached Subcontracting Plan, will be a material breach of such contract or subcontract and subject to the remedies reserved to the Government under FAR Clause 52.219-16 entitled, "Liquidated Damages-Subcontracting Plan."

Subcontracting Reports The Contractor shall submit the following Subcontracting reports electronically via the "electronic Subcontracting Reporting System (eSRS) at http://www.esrs.gov.

Individual Subcontract Reports (ISR) Regardless of the effective date of this contract, the Report is due on the following dates for the entire life of this contract: April 30th

October 30th Expiration Date of Contract

Summary Subcontract Report (SSR) Regardless of the effective date of this contract, the Summary Subcontract Report shall be submitted annually on the following date for the entire life of this contract: October 30th

For both the Individual and Summary Subcontract Reports, the [Contracting Officer/Contract Specialist/title of alternate designee] shall be included as a contact for notification purposes at the following e-mail address: [Contracting Officer/Contract Specialist]

BLOCK 20. ITEM 10, CONTRACTING OFFICER'S REPRESENTATIVE (COR)

The following Contracting Officer's Representative (COR) will represent the Government for the purpose of this contract:

[INCLUDED IN THE AWARD DOCUMENT]

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements;

(2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

[The alternate COR is responsible for carrying out the duties of the COR only in the event that the COR can no longer perform his/her duties as assigned.]

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract;

or (5) otherwise change any terms and conditions of this contract.

[The Contracting Officer hereby delegates the COR as the Contracting Officer's authorized representative responsible for signing software license agreements issued as a result of this contract.]

The Government may unilaterally change the COR designation.

BLOCK 20. ITEM 11. TASK ORDER/DELIVERY ORDER CONTRACT OMBUDSMAN

In accordance with FAR 16.505(b)(5), the following individual has been designated as the NIH Ombudsman for Non-R&D task order and delivery order contracts.

Dr. Richard G. Wyatt NIH Competition Advocate for Non R&D Contracts 1 Center Drive, 160, MSC 0151 Bethesda, MD 20892-0151 Phone: (301) 496-4920

FAX: (301) 402-4273

E mail: WyattRG@mail.nih.gov

FAR Clause 52.212-4 Contract Terms and Conditions-Commercial Items

FAR Clause 52.212‐4

CONTRACT TERMS AND CONDITIONS ‐ COMMERCIAL ITEMS (MAY 2015)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post‐acceptance rights (1) within a reasonable time after the defect was discovered or should have been discovered; and (2) before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g. use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to, 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at FAR 52.233‐1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202‐1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice. (1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized), to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, contract line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(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;

(vii) Name and address of official to whom payment is to be sent;

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

and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic Funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232‐33, Payment by Electronic Funds Transfer‐System for Award Management, or 52.232‐34, Payment by Electronic Funds Transfer‐Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C.

3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, pro‐ vided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment. (1) Items accepted. Payment shall be made for items accepted by the

Government that have been delivered to the delivery destinations set forth in this

(2) Prompt payment. The Government will make payment in accordance with the

Prompt Payment Act (31 U.S.C. 3903) and OMB prompt payment regulations at 5 CFR part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see

52.212‐5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected contract line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six‐month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607‐2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in 32.608‐2 of the Federal Acquisition Regulation in effect on the date of this contract. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall immediately notify the Contracting Officer and request instructions for disposition of the overpayment.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work.

Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the

Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 41 U.S.C. 4712 and 10 U.S.C. 2409 relating to whistleblower protections; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.

(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order: (1) the schedule of supplies/services; (2) the Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause; (3) the clause at 52.212‐5; (4) addenda to this solicitation or contract, including any license agreements for computer software; (5) solicitation provisions if this is a solicitation; (6) other paragraphs of this clause; (7) the Standard Form 1449; (8) other documents, exhibits, and attachments; and (9) the specification.

(t) System for Award Management (SAM).

(1) Unless exempted by an addendum to this contract, the Contractor is responsible during performance and through final payment of any contract for the accuracy and completeness of the data within the SAM database, and for any liability resulting from the Government's reliance on inaccurate or incomplete data. To remain registered in the SAM database after the initial registration, the Contractor is required to review and update on an annual basis from the date of initial registration or subsequent updates its information in the SAM database to ensure it is current, accurate and complete. Updating information in the SAM does not alter the terms and conditions of this contract and is not a substitute for a properly executed contractual document.

(2) (i) If a Contractor has legally changed its business name, “doing business as” name, or division name (whichever is shown on the contract), or has transferred the assets used in performing the contract, but has not completed the necessary requirements regarding novation and change‐of‐name agreements in FAR subpart 42.12, the Contractor shall provide the responsible Contracting Officer a minimum of one business day's written notification of its intention to (A) change the name in the SAM database; (B) comply with the requirements of subpart 42.12; and (C) agree in writing to the timeline and procedures specified by the responsible Contracting Officer. The Contractor must provide with the notification sufficient documentation to support the legally changed name.

(ii) If the Contractor fails to comply with the requirements of paragraph (t)(2)(i) of this clause, or fails to perform the agreement at paragraph (t)(2)(i)(C) of this clause, and, in the absence of a properly executed novation or change‐of‐name agreement, the SAM information that shows the Contractor to be other than the

Contractor indicated in the contract will be considered to be incorrect information within the meaning of the “Suspension of Payment” paragraph of the electronic funds transfer (EFT) clause of this contract.

(3) The Contractor shall not change the name or address for EFT payments or manual payments, as appropriate, in the SAM record to reflect an assignee for the purpose of assignment of claims (see Subpart 32.8, Assignment of Claims). Assignees shall be separately registered in the SAM database. Information provided to the Contractor's SAM record that indicates payments, including those made by EFT, to an ultimate recipient other than that Contractor will be considered to be incorrect information within the meaning of the “Suspension of payment” paragraph of the EFT clause of this contract.

(4) Offerors and Contractors may obtain information on registration and annual confirmation requirements via SAM accessed through:

https://www.acquisition.gov.

(u) Unauthorized Obligations.

(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti‐Deficiency Act violation (31 U.S.C. 1341), the following shall govern:

(i) Any such clause is unenforceable against the Government.

(ii) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the EULA, TOS, or similar legal instrument or agreement is invoked through an “I agree” click box or other comparable mechanism (e.g., “click‐wrap” or “browse‐wrap” agreements), execution does not bind the Government or any Government authorized end user to such clause.

(iii) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.

(2) Paragraph (u)(1) of this clause does not apply to indemnification by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.

(v) Incorporation by reference. The Contractor’s representation and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract. (End of clause)

Alternate I (MAY 2014). When a time‐and‐materials or labor‐hour contract is contemplated, substitute the following paragraphs (a), (e), (i), (l) and (m) for those in the basic clause.

(a) Inspection/Acceptance. (1) The Government has the right to inspect and test all materials furnished and services performed under this contract, to the extent practicable at all places and times, including the period of performance, and in any event before acceptance. The Government may also inspect the plant or plants of the Contractor or any subcontractor engaged in contract performance. The Government will perform inspections and tests in a manner that will not unduly delay the work.

(2) If the Government performs inspection or tests on the premises of the

Contractor or a subcontractor, the Contractor shall…