N02CO82516-8_BASE_DELIVERY_ORDER_ONE_SON.pdf

STATEMENT OF NEED (SON)

**DELIVERY ORDER ONE**

N02CO82516-8

SECTION B - Supplies or Services and Prices

B.1 BRIEF DESCRIPTION OF SUPPLIES

The U.S. Department of Health and Human Services, National Institutes of Health, National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Infections and Immunoepidemiology Branch (IIB) requires 1,000 doses of Food and Drug Administration (FDA)-approved HPV6/11/16/18/31/33/45/52/58 Virus-like Particles with Alum-adjuvant Vaccine (Gardasil-9).

B.2 TYPE OF ORDER

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

B.3. DELIVERY ORDER PRICING

The Contractor shall be paid a fixed price for each CLIN (TBD). A payment schedule will be incorporated at award.

ITEM QTY (Doses) UNIT PRICE TOTAL

Gardisil-9 1,000 $(TBD at award) $(TBD at award)

SECTION C - Description/Specifications/Statement of Work

C.1 PROGRAM DESCRIPTION AND BACKGROUND

Title

HPV6/11/16/18/31/33/45/52/58 Virus-like Particles with Alum-adjuvant Vaccine (Gardasil-9) in Support of the NCI/DCEG/IIB

Background

The vaccines required under this proposed contract vehicle will ultimately be used in an NCI clinical trial, the ESCUDDO study. This study has multiple components, including a non-inferiority randomized clinical trial of one vs. two doses of nonavalent and GlaxoSmithKline (GSK) bivalent vaccines; a comparison of new Human Papillomavirus (HPV) persistent infections between one and two doses of the vaccines to a contemporaneous unvaccinated group, similar in age and region of residence to the vaccinated groups; and, an economic evaluation of each vaccine and dose regimen, in the context of Costa Rica.

The ESCUDDO study is warranted because the NCI/DCEG/IIB’s previous work in the NCI-sponsored Costa Rica Vaccine Trial (CVT) demonstrated strong immune response to the HPV vaccine. Specifically, HPV16 and 18 antibody geometric mean titers for the two-dose versus three-dose group were not significantly different at four years. All women in the one-dose group remained HPV16/18-seropositive over four years; however, these antibody levels were higher than those induced by natural infection, but lower than for two or three doses. Thus, the findings motivated a new investigation of whether vaccination with fewer than three doses would be able to reduce disease incidence.

The NIC/IIB aims to provide public health policy makers with the necessary scientific information required to make evidence-based decisions related to large scale implementation of sustainable, cost-effective HPV vaccine programs. Specifically, evidence of strong protection from a single-dose of either HPV vaccine product may enable nations that cannot afford multi-dose regimens to achieve extensive population coverage by vaccinating a much larger number of HPV-naïve individuals, which, in combination with herd immunity, will result in decreased cervical cancer incidence and mortality over time. It would also support implementation policies that prioritize wider population coverage with one dose over initiating and completing a two-dose protocol region-by-region, which inevitably risks delays and gaps in coverage in some areas. In addition, this publicly-funded trial will demonstrate the potential impact of one or two doses of the nonavalent vaccine in a comparatively high cervical cancer incidence, low- to middle-income country (LMIC). This will inform public health decisions that must account for both effectiveness and cost. If one dose were found not to confer long-term protection, while two doses did, it would represent strong evidence to support widespread implementation of two doses.

Purpose

The purpose of this requirement is to procure 1,000 doses of Gardasil-9 in support of the

NCI/DCEG/IIB.

C.2 REQUIRED PRODUCT(S) / SPECIFICATIONS

C.2.1 1,000 Doses of HPV6/11/16/18/31/33/45/52/58 Virus-like Particles with Alum-adjuvant Vaccine (Gardasil-9)

C.2.1.1 Vaccines shall be provided in 0.5 ml vials C.2.1.2 Vaccines shall have a minimum of 18-month shelf life beyond the date of acceptance by the NCI Contracting Officer’s Representative (COR) C.2.1.3 Vaccines shall be stored at 2-8°C (34-46°F)

C.2.1.4 Vaccines shall not be frozen C.2.1.5 Vaccine temperature shall be maintained with temperature monitor during shipping C.2.1.6 Certificate of analysis shall be provided with each vaccine order

SECTION D - Packaging and Marking

D.1 PACKAGING AND MARKING

All deliverables shall be delivered to the following address and shall be marked as follows:

TBD AT AWARD

SECTION E - Inspection and Acceptance

E.1 INSPECTION AND ACCEPTANCE

Pursuant to FAR clause 52.212-4, all required items described in Section C, 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 Contracting Officer’s Representative (COR), who is responsible for inspection and acceptance of all services, materials, or supplies to be provided by the Contractor.

SECTION F - Deliveries or Performance

F.1 DELIVERABLES AND DELIVERY SCHEDULE

The Contractor shall deliver all required items, as specified in section C, within 14 calendar days of delivery order award. Deliverables shall reference and cite IDIQ contract number __TBD_____ and delivery order number __TBD___.

Deliverables shall be shipped to the following address:

TBD AT AWARD

National Cancer Institute – Frederick 1050 Boyles Street, bldg. 1050 Frederick, MD 21702-1201

F.2 DELIVERY REQUIREMENTS

Pickup and delivery of items under this contract 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 COR and the Contractor. No deliveries shall be made on Saturdays, Sundays, and days of Government closure or Federal legal holidays found at:

http://www.opm.gov/operating_status_schedules.

http://www.opm.gov/operating_status_schedules

SECTION G - Contract Administration Data

G.1 CONTRACTING OFFICER'S REPRESENTATIVE (COR) AUTHORITY

(a) Materials/items to be delivered under this contract must be subject to the technical direction of the Contracting Officer's Representative, or a representative designated in writing. The term "technical direction" includes, without limitation, direction to the Contractor that directs or redirects the labor effort, shifts the work between work areas or locations, fills in details and otherwise serves to ensure that tasks/requirements outlined in the statement of need are accomplished satisfactorily.

(b) Technical direction must be within the scope of the specification(s)/statement of need.

The Contracting Officer's Representative does not have authority to issue technical direction that:

(1) Constitutes a change of assignment or additional work outside the specification(s)/statement of need;

(2) Constitutes a change as defined in the clause entitled "Changes";

(3) In any manner causes an increase or decrease in the contract price, or the time required for contract performance/delivery;

(4) Changes any of the terms, conditions, or specification(s) of the contract;

(5) Interferes with the Contractor's right to perform under the terms and conditions of the contract; or

(6) Directs, supervises or otherwise controls the actions of the Contractor's employees.

(c) Technical direction may be oral or in writing. The Contracting Officer's Representative shall confirm oral direction in writing within five work days, with a copy to the Contracting Officer.

(d) The Contractor shall proceed promptly with performance resulting from the technical direction issued by the Contracting Officers, Representative. If, in the opinion of the Contractor, any direction of the Contracting Officers, Representative, or his/her designee, falls within the limitations in (b), above, the Contractor shall immediately notify the Contracting Officer no later than the beginning of the next Government work day.

(e) Failure of the Contractor and the Contracting Officer to agree that technical direction is within the scope of the contract shall be subject to the terms of the clause entitled "Disputes."

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

TBD AT AWARD

G.2 INVOICE SUBMISSION AND PAYMENT PROVISIONS - COMMERCIAL

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 (Jan 2017) FAR 52.232-25. Highlights of this clause and NIH implementation requirements follow:

G.2.1. 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).

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.

A. 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. 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.

G.2.2 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.

G.2.3 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.

G.2.4 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 Sub-Contractors 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 Sub- Contractor.

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