Statement of Need.pdf

STATEMENT OF NEED

National Cancer Institute 75N91020Q00178 1

1.0 TITLE

Procurement of One (1) CODEX instrument from Akoya Biosciences.

2.0 BACKGROUND

The National Cancer Institute (NCI), Center for Cancer Research (CCR), Experimental Transplantation and Immunology Branch (ETIB) studies the areas of immunotherapy, immune reconstitution, T-cell biology, graft-versus-host-diseases, graft-versus-tumor immunity, hematopoiesis, and hematopoietic stem cell transplantation. Within ETIB, the transplantation therapy section focuses on transplantation immunology and graft-versus-host disease in order to understand the immunologic mechanisms by which post-transplantation cyclophosphamide prevents graft-versus-host disease.

Previously, this laboratory section has largely focused on taking complex tissues to single-cell suspensions in order to study the cellular compositions of these tissues. However, such processes destroy all data of geospatial relationship and interactions of different cell types. The immune mechanisms and immune cell interactions in these disease tissues are understood using sophisticated imaging techniques. Current imaging methods such as immunofluorescence and immunohistochemistry provide only spatial context with limited markers on tissues.

Understanding the complex architecture and heterogeneity in tissue microenvironment of cancer or immune diseases requires a much higher level of detection system. Such a system would enable measurements of multiplexed markers to study cells and their interactions within the tissue microenvironment. While there are single cell technologies to measure multiple markers, they do not provide the associated spatial dimension. The novel highly multiplex immunofluorescence and imaging platform termed CODEX (Co-Detection by indexing) from Akoya Biosciences can detect and analyze more than 40 parameters within a single tissue sample.

3.0 TYPE OF ORDER

This is a Firm Fixed-Price Purchase Order for supplies.

4.0 SPECIAL ORDER REQUIREMENTS

The Contractor shall furnish one (1) CODEX instrument, associated peripherals, and associated training services in accordance with the terms and conditions established in this order

4.1 PRODUCT FEATURES/SALIENT CHARACTERISTICS

4.1.1 CODEX INSTRUMENT

The following product features/characteristics are required for this requirement:

Must have a capacity of imaging 40+ biomarkers within a single tissue sample.

Must be flexible in validating frozen and formalin-fixed paraffin embedded samples.

Must be capable of spatial context for entire tissue samples and preserved for region of interest analysis or H& E staining.

Must provide on-deck loading of assay reagents and reporters.

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Must be capable of automatic imaging.

Must use imaging technique which maintains tissue integrity and does not destroy samples.

Must allow users the flexibility to analyze both formalin-fixed paraffin-embedded (FFPE) tissues and fresh frozen samples.

Must be capable of converting a standard fluorescent microscope into an automated high-dimensional imaging system capable of providing in-situ analysis at the cellular and subcellular scales.

Must be capable of going to single-cell resolution with a 20x objective.

Must be capable of going to subcellular resolution with a 40x objective.

Must have dimensions which do not exceed 28” (W) x 22” (D) x 26” (H)

4.1.2 SOFTWARE SUITE

The following product features/characteristics are required for this requirement:

Must be hosted on the PC supplied with the instrument.

Must include applications for data collection, data processing, and data interpretation.

Must be capable of spatial visualization of cell phenotypes and populations.

Must be capable of formatting images in .RAW format for downstream analysis.

Must be capable of processing data to compensate for drift, background subtraction, deconvolution, and cell segmentation and clustering.

Must be capable of generating spatial network maps.

Must be capable of importing and exporting in .fcs and .csv file formats.

4.2 WARRANTY

The Contractor shall warrant all supplies furnished under this award against any material or manufacturing defects, defective materials, and/or defective workmanship for a minimum of one (1) year after date of installation. The Contractor shall also warrant and imply that all items delivered under this order are merchantable and fit for use for the particular purpose described in the contract in accordance with FAR 52.212-4(o).

If a defect results in lost or decreased performance of supplies furnished under this contract, the Contractor shall cover all parts, materials, labor, and/or travel expenses required to repair or replace the supplies at no cost to the Government.

4.3 DELIVERY & ACCEPTANCE

The instrument and all products shall be shipped and delivered F.O.B. Destination to the following location:

10 Center Drive Bethesda, MD 20892

Pursuant to FAR clause 52.212-4, all supplies and services delivered under this contract are subject to final inspection and acceptance by an authorized representative of the Government.

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NOTE: The Contractor that receives the award will be provided with the complete delivery address and the NCI technical point-of-contact (TPOC) information.

4.4 TRAINING

The Contractor shall provide in-person training for no more than three consecutive, 8-hour workdays for six (6) government personnel. Topics of the training shall include – but are not limited to – the following:

Software installation;

Access to the microscope;

CODEX experiment operations;

Instrument data analysis capabilities; and Instrument image review capabilities for frozen and formalin-fixed paraffin-embedded

(FFPE) samples.

Training shall be held no later than 30-days after delivery, or at a date determined by mutual agreement of the Contractor and the technical point of contact (TPOC). The Contractor shall obtain final approval for all training dates from the TPOC prior to delivering any training.

4.5 SPECIAL CONSIDERATIONS REGARDING DELIVERIES DURING COVID-19

The Contractor shall store or retain all supplies furnished under this order until notified by the NCI Contracting Officer, technical point of contact (TPOC) of a delivery date. The Contractor shall deliver supplies no later than 30-days after notification.

The Contractor shall not sell supplies furnished under this order to another company or party if the NCI is unable to accept delivery due to conditions related to COVID-19.

Training and installation as required by the Statement of Need may be delayed due to conditions related to COVID-19. If services provided under this order are delayed, the Contractor shall provide all services at different times and dates at no additional cost.

The Contractor shall direct all courier and delivery services – including those not operated by the Contractor (e.g. FedEx, USPS, UPS) – to follow the instructions in this section.

All companies delivering to the NIH main campus must comply with Commercial Vehicle Inspection Facility (CVIF) access procedures. Upon arrival, the CVIF will provide a list of buildings and loading docks to delivery personnel.

Deliveries will be logged in at the loading dock, and the loading dock contractor or Government personnel will attempt to contact the TPOC listed on the package. If the TPOC is unable to accept the package, the delivery shall not be left at the loading dock station. The delivery

National Cancer Institute 75N91020Q00178 4 must be returned to the Contractor, and the Contractor must coordinate with the TPOC to deliver on another date at no additional cost.

Deliveries can only be made between 6:00 a.m. and 4:00 p.m. EST, Monday – Friday, excluding federal holidays.

NOTE: This contract includes deliveries to NIH Building 10. Carriers delivering to Building 10 will be required to complete additional steps that include brief medical screening before unloading and entering Building 10 to make deliveries. These steps are necessary to protect patients and staff. Delivery personnel may be asked a series of questions related to recent travels and if any physical symptoms relevant to COVID 19 exist.

5.0 PAYMENT

Payment shall be made (once). Payment authorization requires submission and approval of invoices to the COR and NIH OFM, in accordance with the payment provisions listed below:

The following clause is applicable to all Purchase Orders, Task or Delivery Orders, and Blanket Purchase Agreement (BPA) Calls: PROMPT PAYMENT (JUL 2013) 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 taken into account in the computation of any interest penalty owed the Contractor.

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

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

3. Remittance name must match exactly with name on original order/contract. If the

Remittance name differs from the Legal Business Name, then both names must appear on the invoice.

4. Invoice date.

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

6. NBS document number formats must be included for awards created in the NBS:

Contract Number; Purchase Order Number; Task or Delivery Order Number and Source Award Number (e.g., Indefinite Delivery Contract number; General Services Administration number); or, BPA Call Number and BPA Parent Award Number.

7. Data Universal Numbering System (DUNS) or DUNS + 4 as registered in the Central Contractor Registration (CCR).

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

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

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

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

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

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

B. 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.

C. Mail an original and 1 copy of the itemized invoice to:

National Institutes of Health Office of Financial Management, Commercial Accounts

2115 East Jefferson Street, Room 4B-432, MSC 8500 Bethesda, MD 20892-8500

For inquiries regarding payment call: (301) 496-6088

In order to facilitate the prompt payment of invoices, it is recommended that the vendor submit a photocopy of the invoice to the “Consignee” designated for the acquisition in blocks 6A – 6E of the face page of the Order/Award document.

II. INVOICE PAYMENT

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

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

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

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

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III. INTEREST PENALTIES

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

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

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

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

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

IV. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS,

FAR 52.232-40 (DEC 2013)

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

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

Include the substance of this clause, include this paragraph c, in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items.

V. ELECTRONIC INVOICING PROCEDURES

Effective April 1, 2020 all NIH contractors/vendors invoices should be sent electronically via e-mail to the NIH Office of Financial Management (OFM) and the Contracting Officer (CO) using the electronic submission instructions provided at award.

This section shall remain in full force and effect until the Government formally notifies the Contractor of a return to mail-in invoice procedures detailed in this award.