75N91020Q00004_IDIQ_SON.docx

STATEMENT OF NEED (SON)

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 BRAND NAME OR EQUAL

This requirement is for the procurement of brand name or equal Tarceva (erlotinib hydrochloride) tablets. The Federal Acquisition Regulation (FAR) provision FAR 52.211-6, Brand Name or Equal (AUG 1999) is applicable to this requirement.

B.3 TYPE OF CONTRACT

The contract type shall be Indefinite Delivery Indefinite Quantity (IDIQ).

B.4 TYPE OF ORDERS (IDIQ)

Delivery orders issued under this IDIQ contract shall be firm fixed price.

B.5 MINIMUM AND MAXIMUM QUANTITIES (IDIQ)

The contract minimum for the entire period of performance, including any options, shall be as follows:

The contract maximum for the entire period of performance, including any options, shall be as follows:

B.6 CONTRACT LINE ITEM PRICING (IDIQ)

The price for each firm fixed price delivery order will be based on the prices listed below:

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.

C.2 CONTRACTOR REQUIREMENTS

· The Contractor shall be an FDA-approved manufacturer or authorized distributor of the FDA-approved drug product in the United States.

The 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.

C.3 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

· Bottles shall contain 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

· Bottles shall contain 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

· Bottles shall contain 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.

SECTION D - PACKAGING AND MARKING

D.1 PACKAGING AND MARKING

All deliverables shall be delivered to the Contracting Officer’s Representative (COR) identified in Section G and shall be marked as follows:

D.2 PAYMENT OF POSTAGE AND FEES

All postage and fees related to submitting information including forms, reports, etc. to the Contracting Officer or COR shall be paid by the Contractor.

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 contract, 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 PERIOD OF PERFORMANCE (IDIQ)

The period of performance of the resulting IDIQ award shall consist of a 3-year ordering period from the date of award.

F.2 DELIVERABLES AND DELIVERY SCHEDULE (IDIQ)

Required deliverables shall be transported to the following address within 30 business days or as specified in individual delivery orders:

TBD AT AWARD

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

The Contractor shall submit all required deliverables in accordance with the schedule established in each individual delivery order. Deliverables submitted under each individual delivery order shall reference and cite the contract number and the specific delivery order number.

Deliverables to be provided under individual delivery orders include:

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

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: http://www.hhs.gov/web/section-508/making-files-accessible/index.html;

Federal Government-wide guidance regarding accessibility of documents can be found at: https://www.section508.gov/best-practices, 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.

F.3 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.

F.4 OBSERVANCE OF LEGAL HOLIDAYS AND DAYS OF GOVERNMENT CLOSURE – ONSITE CONTRACTOR EMPLOYEES (a)(1) The performance of this contract requires Contractor employees of the prime Contractor or any Sub-Contractor, affiliate, partner, joint venture, or team member with which the Contractor is associated, including consultants engaged by any of these entities, to have access to, physical entry into, and to the extent authorized, mobility within, a Federal facility.

(2) HHS may close and or deny Contractor access to a Federal facility for a portion of a business day or longer due to any one of the following events:

(i) Federal public holidays for federal employees in accordance with 5 U.S.C. 6103.

(ii) Fires, floods, earthquakes, unusually severe weather to include snowstorms, tornadoes and hurricanes.

(iii) Occupational safety or health hazards.

(iv) Any other reason.

(3) In such events, the Contractor employees may be denied access to a Federal facility, in part or in whole, to perform work required by the contract. Contractor personnel already present at a Federal facility during such events may be required to leave the facility.

(b) In all instances where Contractor employees are denied access or required to vacate a Federal facility, in part or in whole, the Contractor shall be responsible to ensure Contractor personnel working under the contract comply. If the circumstances permit, the Contracting Officer will provide direction to the Contractor, which could include continuing on-site performance during the Federal facility closure period. In the absence of such direction, the Contractor shall exercise sound judgment to minimize unnecessary contract costs and performance impacts by, for example, performing required work off-site if possible or reassigning personnel to other activities if appropriate.

(c) The Contractor shall be responsible for monitoring when the Federal facility becomes accessible and shall resume contract performance as required by the contract.

(d) For the period that Federal facilities were not accessible to Contractor employees, the contracting officer may—

(1) Adjust the contract performance or delivery schedule for a period equivalent to the period the Federal facility was not accessible;

(2) Forego the work;

(3) Reschedule the work by mutual agreement of the parties; or

(4) Consider properly documented requests for equitable adjustment, claim, or any other remedy pursuant to the terms and conditions of the contract.

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 workdays, 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 workday.

(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.

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.

SECTION H - SPECIAL CONTRACT REQUIREMENTS

H.1 CONTRACTOR PERFORMANCE EVALUATION(S)

During the life of this contract, Contractor performance will be evaluated on an interim and final basis pursuant to FAR Subpart 42.15. The Contractor Performance Assessment Reporting System (CPARS) will be utilized for these reviews. Information on CPARS can be located at http://www.cpars.gov.

H.2 ORDERING PROCEDURES (IDIQ)

a. The Contractor will be provided with a description of the schedule, deliverables and other additional instructions as needed for each individual delivery order to be issued under this contract. Requests for delivery order quotations will be issued by email.

b. Requests for delivery order quotations will include special instructions that are particular to the requirement and information concerning the basis for award. The basis for award of any delivery order will be determined by the specific programmatic needs of the requesting agency but will be in accordance with FAR Part 16.505.

c. Individual delivery order evaluation and award will be conducted in accordance with the requirements of FAR 16.5. The Government reserves the right to request quotation revisions that seek additional price discounts, provide revisions to the technical quotation, or clarify aspects of the quotation.

H.3 DELIVERY ORDER INFORMATION (IDIQ)

a. Each delivery order will contain the following minimum information:

(1) Date of award;

(2) Contract number and delivery order number;

(3) Total dollar amount of the delivery order;

(4) Statement of Need, schedule of deliverables and any special instructions;

(5) The name and address of the delivery order COR, if applicable.

b. The Contractor shall submit separate invoices for each delivery order.