75N91020Q00004_Delivery Order 1_SON.docx

STATEMENT OF NEED (SON)

**DELIVERY ORDER ONE**

SECTION B - SUPPLIES OR SERVICES AND PRICES

B.1 BRIEF DESCRIPTION OF SUPPLIES

The National Cancer Institute (NCI), Division of Cancer Treatment and Diagnosis (DCTD), Therapy Evaluation Program (CTEP) requires significant quantities of brand name or equal Tarceva (erlotinib hydrochloride) tablets for clinical trial NCI Protocol A081105 “Randomized Study of Erlotinib Vs Observation in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-Small Cell Lung Cancer (NSCLC).”

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).

Erlotinib – 25 mg tablets

Erlotinib – 100 mg tablets

Erlotinib – 150 mg tablets

SECTION C - DESCRIPTION/SPECIFICATIONS/STATEMENT OF NEED

C.1 PROGRAM DESCRIPTION AND BACKGROUND

TITLE

Brand Name or Equal Tarceva (Erlotinib hydrochloride) Tablets

BACKGROUND

Erlotinib hydrochloride is an inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase currently FDA- approved for patients with metastatic non-small cell lung cancer whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. In some tumor cells signaling through this receptor plays a role in tumor cell survival and proliferation irrespective of EGFR mutation status. Erlotinib hydrochloride reversibly inhibits the kinase activity of EGFR, preventing autophosphorylation of tyrosine residues associated with the receptor and thereby inhibiting further downstream signaling.

PURPOSE

The purpose of this requirement is to procure brand name or equal Tarceva (erlotinib hydrochloride) tablets at the strengths 25 mg, 100 mg, and 150 mg for an ongoing NCI clinical trial.

C.2 PRODUCT FEATURES/SALIENT CHARACTERISTICS

· Tarceva 25 mg (Brand Name or equivalent):

· Tablet formulation, film-coated

· Tablets containing erlotinib hydrochloride equivalent to 25 mg of erlotinib as the freebase

· 240 bottles containing 30 tablets each

· Tarceva 100 mg (Brand Name or equivalent):

· Tablet formulation, film-coated

· Tablets containing erlotinib hydrochloride equivalent to 100 mg of erlotinib as the freebase

· 240 bottles containing 30 tablets each

· Tarceva 150 mg (Brand Name or equivalent):

· Tablet formulation, film-coated

· Tablets containing erlotinib hydrochloride equivalent to 150 mg of erlotinib as the freebase

· 400 bottles containing 30 tablets each

Tablets shall have a minimum of a 12-month shelf life from the date of acceptance by the NCI Contracting Officer’s Representative (COR).

· Product shall be shipped and delivered under temperature-controlled conditions (20-25OC) in accordance with the storage conditions defined on the drug product container label to ensure maintenance of required temperature conditions from the time of shipment until the time of delivery. Temperature monitoring devices shall be included in the shipping container.

· Contractor shall supply Transaction Information, Transaction Statement and Transaction History for the provided drug product lots in accordance with the FDA Drug Supply Chain and Security Act.

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 30 business 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

NCI Clinical Repository 4650 New Design Road, Suite D Frederick, MD 21703

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.

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";

(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 (FFP)

Payment shall be made upon delivery, inspection and acceptance by the Government. 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:

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).

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.

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)

1. 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.

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

1. 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.