RFQ_A0001_75N91024Q00011.pdf

National Cancer Institute RFQ #75N91024Q00011 Page 1 of 32

COMBINED SYNOPSIS / SOLICITATION

Title: Animal Models and Retroviral Vaccines section (AMRVS)

Retrovirus Assay, Reagent, and Viral Stock Preparation Support Notice Type: Combined Synopsis / Solicitation Solicitation Number: 75N91024Q00011 Amendment No.: A0001 Posted Date: 12/07/2023 Response Date: 1/31/2024 by 10:00 AM EST PSC Code: Q301 (Medical‐ Laboratory Testing) NAICS Code: 541380 (Testing Laboratories and Services)

ISSUED BY: National Institutes of Health (NIH), National Cancer Institute (NCI), Office of Acquisitions (OA)

DESCRIPTION:

The Department of Health and Human Services (HHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Center for Cancer Research (CCR), Vaccine Branch (VB), Retroviral Vaccines Branch (RVB), has a need for Laboratory Services for Immunological Assays, Virological Assays, Reagent and Viral Stock Preparation.

This is a Combined Synopsis/Solicitation for commercial items, prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, as supplemented with additional information included in this notice, and shall be processed in accordance with FAR 13.5 – (Simplified Procedures for Certain Commercial Products and Commercial Services). This announcement constitutes the only solicitation that will be provided in relation to the stated need contained herein. This solicitation is issued as a Request for Quote (RFQ) and includes applicable provisions and clauses in effect through FAR Federal Acquisition Circular (FAC) 2024-06 (12/04/2023)

The requirement’s North American Industry Classification System (NAICS) code is 541380 (Testing Laboratories and Services) with a size standard of $19.0 Million.

One single award, the Indefinite Delivery Indefinite Quantity (IDIQ) award is anticipated to be made as a result of this solicitation.

1.0 BACKGROUND

The Vaccine Branch (VB) is a research branch of the Center for Cancer Research (National Cancer Institute, Bethesda, Maryland). It conducts a program of clinical and laboratory research designed to 1) elucidate basic mechanisms of immune response and molecular virology, and 2) apply these to the design and develop vaccines and immunotherapies for the prevention and treatment of cancer and AIDS, as well as viruses that cause cancer.

The AMRVS conducts research on two retroviruses, HTLV-1, and HIV, that respectively cause cancer and neuropathology, and acquired immunodeficiency syndrome (AIDS). The main

National Cancer Institute RFQ #75N91024Q00011 Page 2 of 32 purpose of the AMRVS is preventing HTLV-1 and HIV infection by developing effective vaccines, testing them in preclinical and clinical studies and analyzing the immune responses elicited by immunizations.

2.0 SCOPE

The contractor shall provide services in areas including cell culture and virology, immunology, protein biochemistry, molecular biology, storage of biological material and pick up/delivery of specimens for the Vaccine Branch, Center for Cancer Research, of the National Cancer Institute, Bethesda, Maryland. The specimens will be used solely as described in the tasks set forth below, and apart from these tasks, the Contractor is not authorized to use the specimens received from the Government for any other purpose, and is required to return all samples, residual samples, and items associated with samples to the Government.

The contractor shall have biocontainment facilities with Biosafety level (BSL) 2 with Biosafety level (BSL3) practices to conduct work with human retroviruses and non-human primate retroviruses (HIV, SIV, SHIV, HTLV-1/2), and attenuated poxviruses.

3.0 TASK ORDER REQUIREMENTS

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the task below throughout the period of performance of the IDIQ at the Task Order level as follows:

TASK 1. Shipping and Distribution of Biological Specimens

a) The Contractor shall arrange for pick-up and delivery of specimens, Monday through Friday, except Government holidays, between the Contractor's site and laboratories on the NIH campus (Buildings 41 and 14, 9000 Rockville Pike, Bethesda, MD, 20892- 1360). Pick-up/delivery times shall be specified by the COR or other NCI Investigators and will be approximately between 8:00 AM and 4:30 PM local time. The Contractor shall also arrange shipment of specimens or reagents to outside investigators as requested by the COR. The Contractor shall package biological specimens according to U.S.

Department of Transportation regulations (https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/2020-04/Transporting-Infectious- Substances-Safely.pdf ). The time for the delivery of picked-up specimens should not exceed the overnight, unless differently specified (see tasks 3.1 and 3.2).

b) Possession of specimens/items will be handled before and after normal hours via a telephone call to the necessary investigator or investigator's lab designee. This will only occur if there is an emergency or inclement weather and the time allocated in the contract SOW does not work.

c) The Contractor shall also arrange shipment of specimens or reagents to investigators outside the Government as requested by the COR. The Contractor shall package

National Cancer Institute RFQ #75N91024Q00011 Page 3 of 32 biological specimens according to U.S. Department of Transportation regulations which describes the packaging and transportation (https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/2020-04/Transporting-Infectious- Substances-Safely.pdf ). The packing materials must be of good quality and strong enough to withstand leakage, pressure, vibration, temperature changes, conveyor, and mechanical conditions.

a) Shipping and Packing: The Contractor is responsible for shipping and packing of the materials after work at their site has been performed. The NCI Investigator's lab will supply their own packing materials when items are ready to be sent from their laboratory to the Contractor. Packing materials such as Styrofoam boxes, freezer storage cardboard boxes, or Saf-T-Pak shipping boxes are acceptable containers for the Contractor to use for delivery of materials. The shipping items shall be saved for reuse to cut down on cost.

TASK 2 IMMUNOLOGICAL ASSAYS

Task 2.1 Enzyme-linked immunosorbent assays (ELISA)

The Contractor shall conduct serological assays of human or animal samples supplied by NIH.

Serum or plasma samples provided by the Government shall be tested for the presence of antibodies to human and other mammalian viral proteins or peptides (different clades of HIV, SIV, HTLV-1/2) Enzyme-linked immunosorbent assays (ELISAs). Pepscan assays shall be conducted to determine specific antibody epitopes recognized and ELISAs shall be conducted to determine antibody titers and isotypes.

Task 2.2 Western blots assays

The Contractor shall conduct serological assays of human or animal samples supplied by NIH.

Serum or plasma samples provided by the Government shall be tested for the presence of antibodies to human and other mammalian viral proteins or peptides (different clades of HIV, SIV, HTLV-1/2) using Western blots assays annually.

Task 2.3 CD4/CD8 T cell and CD20 B cell counts

The Contractor shall provide CD4/CD8 T cell and CD20 B cell counts (percentages and absolute numbers) from blood samples from non-human primates. The analysis shall be conducted within 24 hours of collection of the specimen to avoid degradation of the sample. The government shall provide the samples for pick-up within 1-2 hours of collection.

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Task 2.4 Complete Blood Counts (CBC)

The Contractor shall provide complete blood count (CBC) blood samples from non-human primates and/or human. The analysis shall be conducted within 24 hours of collection of the specimen to avoid degradation of the sample. The government shall provide the samples for pick-up within 1-2 hours of collection.

The Contractor shall, upon completion of immunological assays, document the results achieved and report data in sufficient detail. The results and report data shall be provided within 2-3 weeks from the sample pick-up, unless differently required and agreed in each analysis. The Contractor shall provide raw data (as provided by the instrument utilized during the assay) as well as report data in a Microsoft Office format (e.g., Excel, Word, etc.) or any appropriate format depending on the type of analysis. The Contractor shall document in sufficient detail each step taken in performing the task and provide data collected to the specific NCI investigator, as requested.

TASK 3. VIROLOGICAL ASSAYS

Task 3.1 Droplet Digital PCR (ddPCR) assays of RNA SIV gag in plasma

The Contractor shall conduct Droplet Digital PCR (ddPCR) assays of RNA SIV gag in plasma.

The contractor shall purify and quantitate RNA in plasma of non-human primates or humans by ddPCR. Quantitate viral RNAs, including different clades of HIV, SIV, and SHIV as requested by the COR. The ddPCR for viral RNAs shall be sensitive to 15 copies/ml plasma or less. The Contractor shall conduct ddPCR assays weekly over 5 to 15 weeks on 10 to 60 plasma samples per week associated with repeated low-dose SIV or SHIV challenges with a turn-around time of four to five (4-5) days for the weekly assays.

Task 3.2 Droplet Digital PCR (ddPCR) assays DNA SIV gag in tissues

The Contractor shall conduct Droplet Digital PCR (ddPCR) DNA SIV gag in tissues. The contractor shall purify and quantitate DNA in tissue samples of non-human primates or humans by ddPCR. Quantitate viral RNAs, including different clades of HIV and SIV as requested by the COR. The ddPCR for viral RNAs shall be sensitive to 15 copies/ml plasma or less.

The Contractor shall, upon completion of virological assays, document the results achieved and report data in sufficient detail. The results and report data shall be provided within 4-5 days from the sample pick-up for the ddPCR of SIV gag in plasma, or within 2-3 weeks from the sample pick-up for others virological assays, unless differently required and agreed in each assay. The Contractor shall provide raw data (as provided by the instrument utilized during the assay) as well as report data in a Microsoft Office format (e.g., Excel, Word, etc.) or any appropriate format depending on the type of analysis. The Contractor shall document in sufficient detail each step taken in performing the task and provide data collected to the specific NCI investigator, as requested.

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TASK 4. REAGENT PRPEPERATION

Task 4.1 Recombinant SIV and/or HIV envelope proteins of different viral clades

The Contractor shall provide purified, biochemically characterized and biologically active (where appropriate) recombinant viral proteins from infected cells or conditioned media and from bacterial or mammalian expression systems. Provide recombinant viral proteins which could include but is not limited to, regulatory, enzymatic, or structural proteins. Recombinant vectors expressing the proteins or peptides shall be supplied by the government. Purified proteins shall meet a predetermined level of purity and endotoxin content as agreed between the COR and the Contractor (generally purity>90% and endotoxin level<100EU/mg, unless differently required and agreed for each reagent). Generally, the protein purification shall be conducted by using GNL-Agarose resin with chromatography unit and further purifying the most purified fractions by anion exchange chromatography and Q sepharose, however other purifications methods may be required. The Contractor shall also furnish data to the COR confirming that the proteins are of the quantity and meet the specifications of purity and biological activity agreed between the COR and the Contractor before work was started on the product. In performance of this task, the Contractor shall provide either:

Task 4.2 HTLV-1 proteins of different subtypes of HTLV-1

The Contractor shall provide purified, biochemically characterized and biologically active (where appropriate) recombinant viral proteins from infected cells or conditioned media and from bacterial or mammalian expression systems. Provide recombinant viral proteins which could include but is not limited to, regulatory, enzymatic, or structural proteins. Recombinant vectors expressing the proteins or peptides shall be supplied by the government. Purified proteins shall meet a predetermined level of purity and endotoxin content as agreed between the COR and the Contractor (generally purity>90% and endotoxin level<100EU/mg, unless differently required and agreed for each reagent). Generally, the protein purification shall be conducted by using GNL-Agarose resin with chromatography unit and further purifying the most purified fractions by anion exchange chromatography and Q sepharose, however other purifications methods may be required. The Contractor shall also furnish data to the COR confirming that the proteins are of the quantity and meet the specifications of purity and biological activity agreed between the COR and the Contractor before work was started on the product. In performance of this task, the Contractor shall provide either:

Task 4.3 HIV, SIV, or HTLV-1 Overlapping Peptides

The Contractor shall provide overlapping peptides, representing proteins from different clades of or subtypes of the HIV, SIV, or HTLV-1 genomes annually. These shall be 15-mers overlapping by 11 amino acids unless otherwise specified by the COR. The produced peptides shall be delivered to the specific investigator, as requested.

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Task 4.4 Purified Monoclonal Antibodies

The Contractor shall provide purified monoclonal antibodies by expressing antibody genes provided by the Government in 293 T-cells by transfection or by producing stable CHO cell lines and purifying the antibody in quantities up to 50 milligrams. Purified antibodies shall meet a predetermined level of purity and endotoxin content as agreed between the COR and the Contractor (generally purity>90% and endotoxin level<100EU/mg, unless differently required and agreed for each reagent). Generally, the protein purification shall be conducted by using protein-A agarose, however other purifications methods may be required.

TASK 4.5 Synthesize and Purify Codon-Optimized DNA Plasmids

The Contractor shall synthesize and purify codon-optimized genes encoding cellular or viral proteins designed by the Government for eukaryotic or prokaryotic expression. For the individual genes produced, the Contractor shall provide up to 2-50 mg of DNA. Examples include different clades of HIV or SIV primary isolate envelopes (gp160). Deliver the synthesized gene and/or the purified expressed protein to the specific NCI investigator, as requested.

The Contractor shall document in sufficient detail each step taken in performing the task and provide data to the COR confirming that the reagents are of the quantity and meet the specifications of purity and biological activity agreed to between the COR and the Contractor before work was started on the product. The reagents shall be provided within 4-8 weeks from the agreement between the COR and the Contractor to prepare the reagent, unless differently required and agreed in each analysis.

TASK 4.6 VIRAL STOCK PRPERATION

The Contractor shall provide approximately one (1) purified and titered stocks of attenuated recombinant poxviruses or recombinant TK- vaccinia with titers of 109 to 1010 TCID50 or PFU every two years and as requested by the COR. The TK-vaccinia recombinants shall be expanded under BSL2 conditions. Quality control for the expression of heterologous genes shall be provided by Western Blot. The initial viral inocula shall be provided by the Government. The stocks of recombinant viruses shall be stored at -80 until requested by the COR. The Contractor shall deliver viral stocks to the specific NCI investigator, as requested.

The Contractor shall document in sufficient detail each step taken in performing the task and provide data to the COR confirming that the stocks are of the quantity and meet the specifications of purity and biological activity agreed to between the COR and the Contractor before work was started on the product. The stocks shall be provided within 4-8 weeks from the agreement between the COR and the Contractor to prepare the viral stock, unless differently required and agreed in each analysis.

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4.0 PRICE SCHEDULE

The table below contains the pricing for services to be provided by the Contractor during the ordering period of the IDIQ. Under no circumstances shall the Contractor exceed the pricing established below. However, the Contractor may provide additional discounts if deemed appropriate.

Task Unit Pricing for Base Year

Pricing for Year 1

Pricing for Year 2

Pricing for Year 3

Pricing for Year 4

TASK 1 - Shipping and Distribution of Biological Specimens

Per Lot

Task 2.1 - Enzyme-linked immunosorbent assays (ELISA)

Per Assay

Task 2.2 - Western blots assays

Task 2.3 - CD4/CD8 T cell and CD20 B cell counts

Sample

Task 2.4 - Complete Blood Counts (CBC)

Sample

Task 3.1 - Droplet Digital PCR (ddPCR) assays of RNA SIV gag in plasma

Task 3.2 - Droplet Digital PCR (ddPCR) assays DNA SIV gag in tissues

Task 4.1 - Recombinant SIV and/or HIV envelope proteins of different viral clades

Mg.

Task 4.2 - HTLV-1 proteins of different subtypes of HTLV-1

Task 4.3 - HIV, SIV, or HTLV-1 Overlapping Peptides

Set.

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Task 4.4 - Purified Monoclonal Antibodies

TASK 4.5 - Synthesize and Purify Codon- Optimized DNA Plasmids

Task 5 – Viral Stock Preparation

Unit.

5.0 GENERAL CONTRACTOR REQUIREMENTS

Throughout the duration of the Contract the Contractor must provide the following:

5.1 FACILITY REQUIREMENTS

Have biocontainment facilities with Biosafety level (BSL) 2 and with Biosafety level (BSL3) practices to conduct work with human retroviruses and non-human primate retroviruses (HIV, SIV, SHIV, HTLV-1/2), and attenuated poxviruses. The Contractor shall handle the samples and the reagents and provide the Personal Protective Equipment (PPE) to the personnel according to the Biosafety level required by the Centers for Disease Control and Prevention (CDC) (https://www.cdc.gov/labs/pdf/SF__19_308133-A_BMBL6_00-BOOK-WEB-final-3.pdf). These shall assure the safety of the personnel, both Contractor and the Government and preserve the integrity of the samples.

5.2 SAMPLE STORAGE AND HANLING

Have temporary storage capabilities that meet the criteria to store viable cell lines, tittered field isolates, viral challenge stocks and viable cell specimens from inoculated and immunized animals as requested by the COR. These must include:

a) minus 180 degrees Celsius storage maintained by liquid nitrogen, with capability of storing up to 100 1.8ml vials at each time.

b) minus 80 degrees Celsius storage, with capability of storing up to 1500 1.8ml vials at each time.

c) minus 20 degrees Celsius storage, with capability of storing up to 500 1.8ml vials at each time.

The Contractor shall maintain a backup system capable of maintaining materials stored at the required temperatures. Backup systems can include a generator, a battery backup, a CO2, or Liquid Nitrogen backup systems. The Contractor shall provide storage and electronic inventory for viable cell lines, titered field isolates, viral challenge stocks and viable cell specimens from inoculated and immunized animals as requested by the COR. The inventory shall be detailed, National Cancer Institute RFQ #75N91024Q00011 Page 9 of 32 reporting the number of vials for each animal/subject and each specimen type, divided by study and date. The Contractor shall carefully organize the retrieved specimens in a secure container or box, ensuring proper labeling and preservation in accordance with the guidelines provided by NIH or as generally accepted in the scientific field.

The Contractor shall generate and maintain an updated and detailed electronic inventory for all Government samples and reagents temporarily stored at Vendor’s facilities. When requested, the Contractor shall provide the electronic inventory to the Government in a reasonable time, which shall not be less than 24 hours and no more than 7 days from the time of the written request, unless otherwise agreed upon in writing by both parties. The Contractor shall be able to locate and ship samples and reagents stored in the Contractor’s storage within 10 days from the request, unless differently required and agreed between the contractor and the NCI investigator. The Contractor shall be responsible for packaging and shipping the specimens ensuring that all necessary precautions are taken to maintain the integrity of the specimens during transit. The Contractor shall be liable for any damage, loss, or degradation of the specimens that occurs due to mishandling, improper packaging, or failure to comply with the timelines and procedures set forth in this Section. The Government reserves the right to seek appropriate remedies, including but not limited to reimbursement for the value of the specimens and/or termination of the contract. The Contractor shall provide NIH with prompt notification, including tracking information, once the specimens have been shipped, and shall promptly respond to any inquiries by NIH regarding the status of the shipment.

5.3 QUARTERLY REPORTS

Contractor shall provide the Contracting Officer (CO) and Contracting Officers Representative (COR) with a quarterly report summarizing the following information:

a) List of task orders and their status (e.g., Completed/In progress);

b) Summary individual task performed under each task order;

c) Summary of Task Orders billed, or pending invoicing;

d) Number of samples by type currently at contractors’ facility;

All quarterly reports shall be provided via email to the CO and COR. The reports must be provided as a Microsoft Excel document, unless another format is agreed to in advance by both parties in writing.

6.0 GOVERNMENT RESPONSIBILITIES

The Government and the NCI investigator shall be responsible for packaging samples and materials that will be picked up by the courier or shipped to the Contractor. Packing materials such as Styrofoam boxes, freezer storage cardboard boxes, or Saf-T-Pak shipping boxes will be acceptable containers for the NCI investigator to use for delivery of materials.

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The NCI investigator shall be responsible for providing details on the samples that will be shipped for analysis that are required for the Contractor for a) properly and safely handling the samples; b) properly performing the assays; and c) properly performing the analysis of the data generated.

The NCI investigator shall be responsible for providing an electronic list of samples and/or materials shipped to the Contractor during each shipment. The NCI investigator will provide the electronic list via email sent to the Contractor’s point of contact.

7.0 CONTRACT TYPE (IDIQ)

The contract type shall be a Single Award Indefinite Delivery Indefinite Quantity (IDIQ).

8.0 TYPES OF ORDERS (IDIQ)

Anticipated Task Orders issued under this IDIQ contract shall be for severable or non-severable firm-fixed-priced services.

9.0 MINIMUM AND MAXIMUM AMOUNTS (IDIQ)

Against this IDIQ contract the Government shall place task orders totaling a minimum of $25,000.00. This reflects the contract minimum guarantee for the entire period of performance.

The IDIQ contract maximum/ceiling for the entire period of performance, including any options, shall be for the placement of orders totaling a maximum of T.B.D.

The minimum and maximum amounts are as follows:

Minimum IDIQ Guarantee: $25,000.00

Maximum IDIQ Ceiling (Total IDIQ Value): 4,100,500.00

This value represents the total allowable cumulative value of all Task Orders and shall not be exceeded. Further, the Government is not committed nor obligated to issue orders up to the ceiling value.

10.0 ORDERING AUHTORITY

Any duly warranted NCI Contracting Officer within the Office of Acquisitions (OA), Commercial and Strategic Sourcing Branch (CSSB), or Purchasing Branch (PB) with the appropriate contracting authority is authorized to award Task Orders under this contract. For the purposes of this contract, these individuals are referred to as Ordering Contracting Officers

(OCO).

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11.0 ORERING PROCEDURES (IDIQ)

Ordering procedures must comply with FAR 16.505. Ordering services under this contract shall be accomplished by the issuance of written Task Orders specifying the types of services being ordered. All Task Orders issued hereunder are subject to the terms and conditions of this contract. This contract shall control in the event of conflict with any Task Order.

The Contractor shall identify a Service Coordinator to act as the single representative as the Contractor’s primary point-of-contact for request and issuance of orders.

12.0 PERIOD OF PERFORMANCE

The anticipated period of performance for this IDIQ shall be for five (5) years. This time will be referred to as the Ordering Period, during which the Government may issue task orders with appropriate fiscal year appropriations for the procurement of services covered under this IDIQ.

This five (5) year period shall be as follows:

Ordering Period: T.B.D

Task orders 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.

13.0 PLACE OF PERFORMANCE

All services shall be provided at the contractor’s facilities.

14.0 DELIVERY SCHEDULE

All services to be furnished under this contract shall be ordered by issuance of a task order by an appropriately warranted Contracting Officer. All task orders will provide appropriate funding for said orders issued against this IDIQ.

15.0 INSPECTION AND ACCEPTANCE

Pursuant to FAR clause 52.212-4, all work described in the SOW to be delivered under this contract, and subsequent task orders issued against this IDIQ contract are subject to final inspection and acceptance by an authorized representative of the Government. For task orders the authorized representative of the Government shall be identified at the task order level and will be responsible for inspection and acceptance of all services, materials, or supplies to be provided by the Contractor in relation to applicable task order. For the base IDIQ, the authorized representative shall be the Contracting Officers Representative (COR) identified under Section

16.0 below.

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15.2 SECTION 508 OF THE REHABILITATION ACT

Regardless of format, all digital content or communications materials produced as a deliverable under this IDIQ, shall conform to applicable Section 508 Standards to allow Federal employees and members of the public with disabilities to have access to and use of information and data that is comparable to the access to and use of information and data by Federal employees or by members of the public who are not individuals with disabilities. Remediation of any materials that do not comply with the applicable Section 508 requirements as set forth below shall be the responsibility of the Contractor.

HHS guidance regarding accessibility of documents can be found at:

https://www.hhs.gov/web/section-508/accessibility-checklists/index.html

Federal Government-wide guidance regarding accessibility of documents can be found at https://www.section508.gov/, including the documents describing the preferred method of authoring and testing documents produced in Microsoft Word 2013 or later, Microsoft Excel, and files formatted as PDF.

16.0 CONTRACTING OFFICERS REPRESENATIVE (COR)

A Contracting Officer’s Representative (COR) will be assigned to represent the Government for this purpose of this contract. The COR representing the Government on this contract shall be:

TBD UPON AWARD

The COR is responsible for: (1) reviewing work performed by the Contractor; (2) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (3) interpreting the statement of work and any other technical performance requirements; (4) performing technical evaluation as required; (5) performing technical inspections and acceptances required by this contract; and (6) assisting in the resolution of technical problems encountered during performance.

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

or (6) sign written licensing agreements. Any signed agreement shall be incorporated by reference via a modification to the contract.

The Government may change the COR unilaterally at any time during the contract.

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17.0 CONTRACTOR KEY PERSONNEL

Pursuant to HHSAR 352.237-75 (Key Personnel) the contractor shall assign representatives from their company to be the Government’s direct point of contacts for administrative and technical matters pertaining to the IDIQ and subsequent Task Orders. For the purposes of this contract, these individuals will be referred to as the following:

1. Project Manager – The Project Manager shall be responsible for oversight of day-to-day activities associated with requirements issued under the IDIQ contract and shall serve as the contractor’s technical point of contact for matters involving the performance of task.

2. Service Coordinator – The Service Coordinator shall be the single point of contact for all administrative matters pertaining to the contract to include (e.g., Task Order Request for Quotes (TORFQ), Providing Quarterly Reports, Invoicing etc.). This individual shall also have appropriate authority to make obligations on behalf of the Contractor’s organization, as well as authority to resolve potential disputes that may arise in relation to the IDIQ, or subsequent Task Orders.

18.0 OBSERVANCE OF FEDERAL HOLIDAYS

No services or deliveries shall be performed on Saturdays, Sundays, or Federal holidays as shown below:

New Year’s Day – January 1 Martin Luther King’s Birthday – Third Monday in January President’s Day – Third Monday in February Memorial Day– Last Monday in May Juneteenth – June 19 Independence Day – July 4 Labor Day – First Monday in September Columbus Day – Second Monday in October Veterans Day – November 11 Thanksgiving Day – Fourth Thursday in November Christmas Day – December 25

In addition to the days designated as holidays; the Government observes the following holidays:

• Any other day designated by Federal Statute

• Any other day designated by Executive Order

• Presidential Inauguration Day

• Any other day designated by the President’s Proclamation

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It is understood and agreed between the Government and the Contractor that observance of such holidays by Government personnel shall not otherwise be a reason for an additional period of performance, or entitlement of compensation, except as set forth within the order(s). In the event the Contractor’s personnel work during the holiday, they may be reimbursed by the Contractor, however, no form of holiday or other premium compensation will be reimbursed either as a direct or indirect cost, other than their normal compensation for the time worked.

19.0 SPECIAL CONTRACT REQUIREMENTS AND UNDERSTANDINGS

19.1 Non-Research and Development (R&D)

Both the Government and the Contractor agree this acquisition is being conducted under non- Research and Development (R&D) procedures; therefore, the following non-R&D terms and conditions apply:

a. HUMAN SUBJECTS

It is hereby understood and agreed that research involving human subjects shall not be conducted under this contract and that no material developed, modified, or delivered by or to the Government under this contract, or any subsequent modification of such material, will be used by the Contractor or made available by the Contractor for use by anyone other than the Government, for experimental or therapeutic use involving humans. Reference https://www.hhs.gov/ohrp/index.html for more information.

b. CONFIDENTIALITY Section 2012 of the 21st Century Cures Act, enacted December 13, 2016, enacts new provisions governing the authority of the Secretary of Health and Human Services (Secretary) to protect the privacy of individuals who are the subjects of research, including significant amendments to the previous statutory authority for such protections, under subsection 301(d) of the Public Health Service Act. No research involving the collection or use of identifiable, sensitive information shall occur under this contract including:

Human subjects research as defined in the Federal Policy for the Protection of Human

Subjects (45 CFR 46), including exempt research (except for human subjects' research that is determined to be exempt from all or some of the requirements of 45 CFR 46) if the information obtained is recorded in such a manner that human subjects cannot be identified or the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects);

Research involving the collection or use of biospecimens that are identifiable to an individual or for which there is at least a very small risk that some combination of the biospecimen, a request for the biospecimen, and other available data sources could be used to deduce the identity of an individual;

Research that involves the generation of individual level, human genomic data from biospecimens, or the use of such data, regardless of whether the data is recorded in such a

National Cancer Institute RFQ #75N91024Q00011 Page 15 of 32 manner that human subjects can be identified or the identity of the human subjects can readily be ascertained as defined in the Federal Policy for the Protection of Human Subjects (45 CFR 46); or

Any other research that involves information about an individual for which there is at least a very small risk, as determined by current scientific practices or statistical methods, that some combination of the information, a request for the information, and other available data sources could be used to deduce the identity of an individual, as defined in subsection 301(d) of the Public Health Service Act.

c. HUMAN MATERIALS

The acquisition and supply of human specimen material (including fetal material) shall not be conducted under this contract.

d. ANIMAL WELFARE

It is hereby understood and agreed that the Contractor shall not use live, vertebrate animals for any work conducted under this contract. Reference the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy). The PHS Policy can be accessed at: https://olaw.nih.gov/policies-laws/phs-policy.htm .

e. INSTITUTIONAL REVIEW BOARD (IRB)

The Government has determined this to be a non-R&D requirement. Should the Contractor require Institutional Review Board (IRB) approval for any work conducted under this agreement, the Contractor shall promptly notify the Contracting Officer and Contracting Officer’s Representative in writing and immediately stop work until written Contracting Officer Authorization to continue performance is provided.

If at any time during the performance of this contract, the Contractor is not in compliance with paragraphs a. through e. above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. Notice of the suspension may be communicated by telephone and confirmed in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer's written notice of suspension, the Contracting Officer may, in consultation with the Office for Human Research Protections (OHRP), Department of Health and Human Services or Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), terminate this contract in whole or in part.

19.2 SMALL BUSINESS SUBCONTRACTING PLAN

If the proposed contract exceeds a total estimated cost of $750,000 for the entire period of performance, the Quoter shall be required to submit an acceptable subcontracting plan in accordance with the terms of the clause entitled "Small Business Subcontracting Plan," FAR Clause No. 52.219-9, incorporated herein by reference in the Solicitation under FAR Clause No.

52.212-5. In accordance with FAR 19.704 and FAR Clause 52.219-9, the submission of a

National Cancer Institute RFQ #75N91024Q00011 Page 16 of 32 subcontracting plan by other than small business Quoter(s) is a requirement as a part of the quotation submission process. Apparent successful Quoter's subcontracting plan must be determined to be acceptable by the Contracting Officer, prior to the contract award.

1. Quoter’s must submit a subcontracting plan with their quote submittal. Only the apparent successful quoter will be invited to submit their respective subcontracting plan electronically using the U.S. Department of Health and Human Services (HHS) Small Business Customer Experience (SBCX) system at https://osdbu.hhs.gov . The quoter must follow the instructions outlined in the SBCX Industry Guide instructions outlined in the SBCX Industry Guide at: https://oamp.od.nih.gov/nih-document-generation-system/dgs-workform-information/attachment-files-section-j to successfully submit their subcontracting plan.

2. The official point of receipt for determining timely submission of a quoter's subcontracting plan is the SBCX system and/or email notification. Once the subcontracting plan is successfully submitted to the SBCX system the quoter should receive an email notification and confirmation message of completion upon submission.

3. If the quoter's subcontracting plan is not confirmed as received within the SBCX system by the requested submission date specified in the invitation, it will be considered late in accordance with the Request for Quotes (RFQ). Disposition of late submittals of a subcontracting plan by the quoter via the SBCX system is at the discretion of the Contracting Officer.

4. Any technical questions regarding the use of the SBCX system may be submitted via email message to the SBCX help desk at client.support@apexlogic.com . The client support hours of operation are Monday - Friday, 6:00 a.m. - 8:00 p.m. Eastern Standard Time (EST). Note: help desk tickets can be submitted 24 hours a day / 7 days a week and a representative will respond within the presented client support hours of operation for assistance.

a. THIS PROVISION DOES NOT APPLY TO SMALL BUSINESS CONCERNS.

b. The term "subcontract" means any agreement (other than one involving an employer-employee relationship) entered into by a Federal Government prime Contractor or subcontractor calling for supplies or services required for the performance of the original contract or subcontract. This includes, but is not limited to, agreements/purchase orders for supplies and services such as equipment purchase, copying services, and travel services.

c. The Quoter understands that:

i. No contract will be awarded unless and until an acceptable plan is agreed upon with the

Contracting Officer which will then be incorporated into the contract, as a material part thereof.

ii. An acceptable plan must, in the determination of the Contracting Officer, provide the maximum practicable opportunity for Small Businesses, Small Disadvantaged Businesses, Women-Owned Small businesses, HUBZone Small Businesses, Veteran-

National Cancer Institute RFQ #75N91024Q00011 Page 17 of 32

Owned Small Businesses, and Service Disabled Veteran-Owned Small Businesses to participate in the performance of the contract.

iii. If a subcontracting plan acceptable to the Contracting Officer is not agreed upon within the time limits prescribed by the contracting activity and such failure arises out of causes within the control and with the fault or negligence of the Quoter, the Quoter shall be ineligible for an award. The Contracting Officer shall notify the Contractor in writing of the reasons for determining a subcontracting plan unacceptable early enough in the award process to allow the Contractor to modify the plan within the time limits prescribed.

iv. Prior compliance of the Quoter with other such subcontracting plans under previous contracts will be considered by the Contracting Officer in determining the responsibility of the Quoter for award of the contract.

v. It is the quoter's responsibility to develop a satisfactory subcontracting plan with respect to Small Business Concerns, Small Disadvantaged Business Concerns, Women-Owned Small Business Concerns, HUBZone Small Business Concerns, Veteran-Owned Small Business Concerns, and Service Disabled Veteran-Owned Small Business Concerns that each such aspect of the Quoter's plan will be judged independent of the other.

vi. The quoter will submit, as required by the Contracting Officer, subcontracting reports in accordance with the instructions thereon, and as further directed by the Contracting Officer.

d. Each plan must contain the following:

i. Goals, expressed in terms of percentages of total planned subcontracting dollars, for the use of Small, Small Disadvantaged, Women-Owned, HUBZone, Veteran-Owned, and Service Disabled Veteran-Owned Small Business Concerns as subcontractors.

ii. A statement of total dollars planned to be subcontracted. A statement of total dollars to be subcontracted to each of the following type of small business concerns: Small, Small Disadvantaged, Women-Owned, HUBZone, Veteran-Owned, and Service Disabled Veteran-Owned Small Businesses.

iii. A description of the principal types of supplies and services to be subcontracted with an identification of which supplies and services are expected to be subcontracted to Small, Small Disadvantaged, Women-Owned, HUBZone, Veteran-Owned and/or Service Disabled Veteran-Owned Small Business Concerns.

iv. A description of the method used to develop the subcontracting goals.

v. A description of the method used to identify potential sources for solicitation purposes.

vi. A statement as to whether or not indirect costs were included in establishing subcontracting goals. If they were, a description of the method used to determine the proportionate share of indirect costs to be incurred with Small, Small Disadvantaged, Women-Owned, HUBZone, Veteran-Owned, and Service Disabled Veteran-Owned Small Businesses.

vii. The name of the individual employed by the Quoter who will administer the Quoter's subcontracting program and a description of his/her duties.

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viii. A description of the efforts the Quoter will make to assure that Small, Small Disadvantaged, Women-Owned, HUBZone, Veteran-Owned, and Service Disabled Veteran-Owned Small Businesses have an equitable chance to compete for subcontracts.

ix. Assurances that the Quoter will include in all subcontracts the contract clause "Utilization of Small Business Concerns." Assure that all subcontractors, other than small businesses, in excess of $750,000 adopt a plan similar to the plan agreed upon by the Quoter.

x. Assurances that the quoter will cooperate in studies or surveys as required and submit required reports (Individual Subcontract Reports (ISRs) and Summary Subcontract Reports (SSRs) to the Government at https://www.esrs.gov/.

xi. List the types of records the Quoter will maintain to demonstrate procedures that have been adopted to comply with the requirement and goals in the plan, including establishing source lists. Also, the Quoter shall describe its efforts to locate Small, Small Disadvantaged, Women-Owned, HUBZone, Veteran-Owned, and Service Disabled Veteran-Owned Small Businesses and award subcontracts to them.

For additional information about each of the above elements required to be contained in the subcontracting plan, see FAR Clause 52.219-9, Small Business Subcontracting Plan.

HHS expects each procuring activity to establish minimum subcontracting goals for all procurements. The anticipated minimum goals for this RFQ are as follows:

32% for Small Business; 5% for Small Disadvantaged Business; 5% for Women-Owned Small Business; 3% for HUBZone Small Business; and 3% for Veteran-Owned Small Business and Service-Disabled Veteran-Owned Small Business.

20.0 PAYMENT/INVOICING

Specific payment instructions will be identified at the Task Order Level. The following clause is applicable to all Task Orders: Prompt Payment (Jan 2017) FAR 52.232-25. Highlights of this clause and NIH implementation requirements follow:

I. Invoice Requirements

A. An invoice is the Contractor's bill or written request for payment under the contract for supplies delivered or services performed. A proper invoice is an "Original" which must include the items listed in subdivisions 1 through 12, below, in addition to the requirements of FAR 32.9.

If the invoice does not comply with these requirements, the Contractor will be notified of the defect within 7 days after the date the designated billing office received the invoice (3 days for meat, meat food products, or fish, and 5 days for perishable agricultural commodities, dairy products, edible fats, or oils) with a statement of the reasons why it is not a proper invoice. (See exceptions under II., below.) Untimely notification will be considered in the computation of any interest penalty owed the Contractor.

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

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

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

4. Invoice date.

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

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

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

8. Federal Taxpayer Identification Number (TIN). In those rare cases where a contractor does not have a UEI number or TIN, a Vendor Identification Number (VIN) must be referenced on the invoice. The VIN is the number that appears after the contractor’s name on the face page of the award document.

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

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

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

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

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

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

B. The Contractor shall submit invoices to the Department of Treasury’s Invoice Processing Platform (IPP) at https://www.ipp.gov with a copy to the approving official, as directed below.

The Contractor shall submit a copy of the electronic invoice to the following Contracting Officer’s Representative (COR) and Invoicing Approver (IP):

COR: TBD at Task Order level

IP: TBD at Task Order level

National Cancer Institute RFQ #75N91024Q00011 Page 20 of 32

*The PA is the best point of contact for invoicing and payment questions.

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

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

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

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

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

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