SOW Olink Explore 3072_DRAFT.pdf

STATEMENT OF WORK

1.0 TITLE

Olink Explore 3072 Analysis Services for NCI/CCR/POB

2.0 BACKGROUND

The National Institutes of Health (NIH), National Cancer Institute’s (NCI’s) Center for Cancer Research (CCR), Pediatric Oncology Branch (POB) is dedicated to improving outcomes for children and young adults with cancer and genetic tumor predisposition syndromes. Malignant peripheral nerve sheath tumors (MPNST) are aggressive cancers with a poor prognosis, and screening for malignant transformation is challenging. MPNST, in the setting of neurofibromatosis type 1 (NF1), frequently arise from within their benign plexiform neurofibroma (PN) or pre-malignant atypical neurofibroma (AN) precursors. Earlier definitive detection would improve clinical outcomes by enabling patients to receive therapeutic intervention while disease burden is still minimal. POB is in the process of investigating potential circulating protein biomarkers for early disease detection.

The NCI/POB requires the expansion and validation of previous pilot data results conducted on panel Olink Explore 1536, Task Order 75N91022D00001/75N91022F00001.

2.1 OBJECTIVE

The primary objective of this order is to receive normalized expression data from multiplexed immunoassays, using the Olink Explore 3072 platform, to enable POB to describe the secreted proteome of NF1 associated PN, AN and MPNST in clinical plasma samples.

3.0 SCOPE

Olink Proximity Extension Assay (PEA) Technology: Serum will be isolated from clinical samples and sent to Olink Boston. The Contractor shall then prepare multi-plexed immunoassays for high-throughput analysis of proteins contained in the plasma and their relative amounts.

Data Analysis: The Contractor shall transform immunoassay output into normalized expression which will then be delivered to the Technical Point of Contact (TPoC) for review and analysis.

Independently, and not as an agent of the Government, the Contractor shall furnish all necessary labor, materials, supplies, equipment, and services not otherwise provided by the Government.

NOTE: NCI will arrange shipment(s) of the samples to the Contractor. Upon completion of all analysis services, the Contractor shall destroy any residual samples.

The Contractor shall perform the following tasks:

3.1 TASK 1

The NCI/CCR/POB will isolate and ship clinical plasma samples in a single batch to the Contractor within 4 weeks of the date of award. POB anticipates to ship 88 samples in total. The Contractor shall then, in accordance with the manufacturer’s instructions:

a) Receive the samples and confirm their arrival by email to POB’s Technical Point of Contact (TPOC; see Section 7.0 below).

b) Prepare the samples for multiplexed immunoassays by aliquoting and randomizing the samples on assay plates (product code (P/C) 91030).

c) Conduct multiplexed immunoassays, with the Olink Explore 3072 panel of protein targets (P/C 91122), for high-throughput analysis of proteins contained in the plasma and their relative amounts. This shall include a combination of eight (8) separate Olink Explore 384 panels:

a. Inflammation 1 (P/C 91101) and Inflammation 2 (P/C 91105),

b. Oncology 1 (P/C 91102) and Oncology 2 (P/C 91106),

c. Cardiometabolic 1 (P/C 91103) and Cardiometabolic 2 (P/C 91107), and

d. Neurology 1 (P/C 91104) and Neurology 2 (P/C 91108).

d) Transform immunoassay outputs into normalized expression data. The Contractor shall convert immunoassay outputs into log2 scale Normalized Protein eXpression (NPX) data.

e) Deliver the normalized expression results to POB’s TPOC for analysis, together with an analysis report. NPX data shall be delivered to the Government via the Contractor’s secure cloud-based service (us.mydata.olink.com).

4.0 TYPE OF ORDER

This shall be a firm fixed price purchase order.

4.1 SEVERABLE SERVICES

The services specified in each contract line item (CLIN) have been determined to be non-severable services – a specific undertaking or entire job with a defined end-product of value to the Government.

5.0 PERIOD OF PERFORMANCE

The period of performance shall be for 6 months from date of award.

6.0 PLACE OF PERFORMANCE

All work shall be performed at the Contractor’s facility:

Olink Proteomics Inc. / Analysis Service Boston 130 Turner St. Building 2, Suite 230 Waltham, MA 02453, USA

7.0 REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE

Pursuant to FAR clause 52.212-4, all work to be delivered under this task order is subject to final inspection and acceptance by an authorized representative of the Government. The authorized representative of the Government is the Technical Point of Contact (TPOC), who is responsible for inspection and acceptance of all services, materials, or supplies to be provided by the Contractor.

POB Technical Point of Contact :

TBD Phone:

Email:

The deliverables shall be provided to the NCI TPOC via a secure cloud-based service located at https://us.mydata.olink/com. The TPOC will receive login credentials and information about the cloud-based service and establish accounts (“MyData account”) in order to receive the required deliverables identified in the task order. Deliverables are deemed submitted when Olink uploads the deliverables to the Government’s MyData account and has provided written notices to the NCI TPOC.

https://us.mydata.olink/com

NCI shall have 30 days in which to review and accept the deliverables provided by the Contractor. If no comments or request for revisions are provided within 30 days, the deliverables shall be considered acceptable.

7.1 Delivery Schedule

Deliverable Deliverable Description / Format Requirements Due Date

Deliverable 1 (Task 1)

Protein extension assay for POB: Spreadsheet with Normalized Protein eXpression (NPX)

Within 90 days after receipt of samples

Deliverable 2 (Task 1)

Analysis Report for POB: Summary of multiplex immunoassay details including samples run, intra- and inter-assay coefficient of variance (%CV) and quality control metric.

Within 90 days after receipt of samples

Any deliverable created as a direct result of this procurement shall be the sole propriety of NCI and shall not be shared or distributed without written consent of the Executive Officer, NCI. Regardless of format, all digital content or communications materials produced as a deliverable under this contract, 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/additional-resources/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.

8.0 PRICE SCHEDULE (for reference in response to Request for Quote)

Item Product Code Description Unit Price Qty Total Task 1

1 91030 Sample preparation (per hour) 2 2 91122 Olink Explore 3072 Analysis Service 88

9.0 PAYMENT

Payment shall be made in full upon successful completion and acceptance of all deliverables. Payment authorization requires submission and approval of invoices to the Technical Points of Contact and NIH OFM, in accordance with the attached payment provisions listed below:

https://www.hhs.gov/web/section-508/additional-resources/index.html https://www.section508.gov/

The following clause is applicable to all Purchase Orders, Task or Delivery Orders, and Blanket Purchase Agreement (BPA) Calls: 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.

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 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.

https://www.ipp.gov/

The Contractor shall submit a copy of the electronic invoice to the following Approving Official (Technical Point of Contact):

Approving Official: Technical Point of Contact Names: TBD Email Addresses: TBD

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.

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 (November 2021)

(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.

(c) Include the substance of this clause, including this paragraph (c), in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial products or commercial services.

(End of Clause) mailto:rick.huang@nih.gov

V. HHSAR 352.232-71 Electronic Submission of Payment Requests (February 2, 2022)

(a) Definitions. As used in this clause—

Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), ‘‘Content of Invoices’’ and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer’s written authorization with each payment request.

(End of Clause) http://www.ipp.gov/