Attachment 1 Delivery Order One.pdf

STATEMENT OF NEED (SON)

Attachment 1 - **DELIVERY ORDER ONE**

Attachment 1 RFQ No. 75N91023Q00019 Page 1 of 6

SECTION 1 – REQUIRED ITEMS AND PRICING

1.1 TITLE

Brand Name or Equal nilotinib (Tasigna®) Capsules

1.2 TYPE OF ORDER

This is a firm fixed price delivery order issued under IDIQ contract number TBD.

1.3 BRIEF DESCRIPTION OF SUPPLIES

The National Cancer Institute (NCI), Division of Cancer Treatment and Diagnosis (DCTD), Cancer Therapy Evaluation Program (CTEP), requires Nilotinib Tasigna® capsules, or equivalent, for the conduct of clinical trial NCI Protocol EAY191-E4 “Nilotinib and Paclitaxel in Patients with Prior Taxane-Treated Solid Tumors.”

1.4 DELIVERY ORDER PRICING

The Contractor shall be paid a fixed price for each CLIN. Payment shall be made upon the delivery and acceptance of the items listed below:

ITEM

QTY (one blister containing 28 capsules each)

UNIT PRICE TOTAL

Nilotinib 150 mg capsules

120 TBD TBD

Nilotinib 200 mg capsules

36 TBD TBD

SECTION 2 – ITEM DESCRIPTION / SPECIFICATIONS

2.1 BACKGROUND

Nilotinib (Tasigna®) is an inhibitor of the BCR-ABL kinase. Nilotinib binds to and stabilizes the inactive conformation of the kinase domain of ABL protein. In vitro, nilotinib inhibited BCR-ABL mediated proliferation of murine leukemic cell lines and human cell lines derived from patients with Ph+ CML. Under the conditions of the assays, nilotinib was able to overcome resistance resulting from BCR-ABL kinase mutations, in 32 out of 33 mutations tested. Nilotinib inhibited the autophosphorylation of the following kinases: BCR-ABL, PDGFR, c-KIT, CSF-1R, and DDR1.

Attachment 1 RFQ No. 75N91023Q00019 Page 2 of 6

2.2 PURPOSE

The purpose of this requirement is to procure Nilotinib (Tasigna®) capsules at the strengths 150 mg and 200 mg for an NCI clinical trial.

2.3 PRODUCT FEATURES/SALIENT CHARACTERISTICS

The contractor shall provide the following product with features/characteristics as described:

• Nilotinib (Tasigna®) 150 mg (brand name or equal):

o Capsule formulation, hard gelatin size 1 o Capsules containing nilotinib monohydrochloride monohydrate salt, equivalent to 150 mg of nilotinib base, anhydrous o 120 blisters containing 28 capsules each

• Nilotinib (Tasigna®) 200 mg (brand name or equal):

o Capsule formulation, hard gelatin size 0 o Capsules containing nilotinib monohydrochloride monohydrate salt, equivalent to 200 mg of nilotinib base, anhydrous o 36 blisters containing 28 capsules each

• The capsule expiration date shall not be less than 18-months from the date of receipt by the NCI.

• Blisters shall be stored and shipped at controlled room temperature (20-25OC) in accordance with the storage conditions defined on the drug product container label to ensure required temperature conditions from the time of shipment until the time of delivery. Each shipment shall include a temperature monitoring device.

SECTION 3 – DELIVERIES AND PERFORMANCE

3.1 PACKAGING AND MARKING

All deliverables shall be delivered to and marked in accordance with section 2.2.

3.2 INSPECTION AND ACCEPTANCE

Pursuant to FAR clause 52.212-4, all required items described in Section 2.2, to be delivered under this delivery order, are subject to final inspection and acceptance by an authorized representative of the Government. The authorized representative of the Government is the NCI Technical Point of Contact (TPOC), who is responsible for inspection and acceptance of all services, materials, or supplies to be provided by the Contractor.

Attachment 1 RFQ No. 75N91023Q00019 Page 3 of 6

3.3 DELIVERABLES AND DELIVERY SCHEDULE

The Contractor shall deliver all required items within 30 calendar days of delivery order award.

Deliverables shall reference and cite the IDIQ contract number (TBD) and delivery order number

(TBD).

Deliverables shall be shipped to the following address:

(TBD AT AWARD)

3.4 DELIVERY REQUIREMENTS

Pickup and delivery of items under this delivery order shall be accomplished between the hours of 9:00 a.m. and 4:00 p.m., Monday through Friday unless changed by mutual agreement between the TPOC and the Contractor. No deliveries shall be made on Saturdays, Sundays, and days of Government closure or Federal legal holidays found at: https://www.opm.gov/policy-data-oversight/pay-leave/federal-holidays/.

SECTION 4 – CONTRACT ADMINISTRATION

4.1 NCI TPOC

The following TPOC will represent the Government for the purpose of this delivery order:

TBD at award

4.2 INVOICE SUBMISSION / PAYMENT

Payment shall be made upon delivery, inspection and acceptance by the Government. Payment authorization requires submission and approval of invoices to the NCI 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 (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 https://www.opm.gov/policy-data-oversight/pay-leave/federal-holidays/ https://www.opm.gov/policy-data-oversight/pay-leave/federal-holidays/

Attachment 1 RFQ No. 75N91023Q00019 Page 4 of 6 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.

Attachment 1 RFQ No. 75N91023Q00019 Page 5 of 6

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 Approving Official (Contracting Officer) and Contracting Officer’s Representative:

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 https://www.ipp.gov/

Attachment 1 RFQ No. 75N91023Q00019 Page 6 of 6 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.

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.