SOLICITATION NOTICE
65 -- Procurement of Brand Name Gardasil-9 Vaccines - Package #1
- Notice Date
- 7/18/2018
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 325412
— Pharmaceutical Preparation Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States
- ZIP Code
- 20852
- Solicitation Number
- N02CO82516-8
- Archive Date
- 8/10/2018
- Point of Contact
- Megan N. Kisamore, Phone: 2402765261
- E-Mail Address
-
megan.kisamore@nih.gov
(megan.kisamore@nih.gov)
- Small Business Set-Aside
- N/A
- Description
- N02CO82516-8_BRAND NAME JUSTIFICATION_REDACTED N02CO82516-8_DELIVERY ORDER ONE_SON N02CO82516-8_BASE IDIQ_SON 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 - 16,000 doses of Food and Drug Administration (FDA)-approved, brand name HPV6/11/16/18/31/33/45/52/58 Virus-like Particles with Alum-adjuvant Vaccine (Gardasil-9). This is a combined synopsis/solicitation for commercial items, prepared in accordance with the format in FAR subpart 12.6, as supplemented with additional information included in this notice, and shall be processed in accordance with FAR subpart 13.5 - Simplified Procedures for Certain Commercial Items. This announcement constitutes the only solicitation and a separate written solicitation will not be issued. This solicitation, #N02CO82516-8, is issued as a request for quote (RFQ), and includes all applicable provisions and clauses in effect through FAR Federal Acquisition Circular (FAC) 2005-99-1 / 07-16-2018, simplified acquisition procedures for commercial items. The North American Industry Classification System code is 325412 and the business size standard is $38.5 million. The anticipated award shall be a firm fixed price, indefinite delivery/indefinite quantity (IDIQ) type contract. The Government anticipates a single-award IDIQ. The period of performance of the resulting IDIQ award shall consist of a 3-year ordering period. Multiple delivery orders are anticipated during the 3-year ordering period. See attached Statement of Need (SON) for more information. Description of Requirement The required brand name Gardasil-9 vaccines will ultimately be used in an ongoing NCI clinical trial, the ESCUDDO study. The NCI/DCEG/IIB's procurement of Gardasil-9 vaccines is essential to maintain consistency with the Gardasil-9 vaccines that were previously procured and administered to patients under the aforementioned clinical trial. Any deviation from the procurement and administration of brand name Gardasil-9 vaccines would compromise the outcome of the study, as the subsequent data would not be scientifically comparable with previously collected data. - Vaccines shall be provided in 0.5 ml vials; - Vaccines shall have a minimum of 18-month shelf life beyond the date of acceptance by the NCI Contracting Officer's Representative (COR); Vaccines shall be stored at 2-8°C (34-46°F); - Vaccines shall not be frozen; - Vaccine temperature shall be maintained with temperature monitor during shipping; - Certificate of analysis shall be provided with each vaccine order; and - Vaccines shall be delivered within 14 calendar days of delivery order award Delivery Required deliverables shall be transported to 1050 Boyle Street, Bldg 1050 Frederick, MD 21702-1201; or, as specified in individual delivery orders. 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. Payment Payment authorization requires submission and approval of invoices to the COR and NIH OFM, in accordance with the payment provisions listed in the attached SON. Provisions and Clauses The following Federal Acquisition Regulation and Health & Human Services Acquisition Regulation Provisions/Clauses apply to this acquisition: FAR 52.216-18 ORDERING (OCT 1995) (a) Any supplies to be furnished under this contract shall be ordered by issuance of delivery orders by the individuals or activities designated in the Schedule. Such orders may be issued three (3) years from the date of award. (b) All delivery orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order and this contract, the contract shall control. (c) If mailed, a delivery order is considered "issued" when the Government deposits the order in the mail. Orders may be issued orally, by facsimile, or by electronic commerce methods only if authorized in the Schedule. FAR 52.216-22 INDEFINITE QUANTITY (OCT 1995) (a) This is an indefinite-quantity contract for the supplies specified, and effective for the period stated, in the Schedule. The quantities of supplies specified in the Schedule are estimates only and are not purchased by this contract. (b) Delivery shall be made only as authorized by orders issued in accordance with the Ordering clause. The Contractor shall furnish to the Government, when and if ordered, the supplies specified in the Schedule up to and including the quantity designated in the Schedule as the "maximum." The Government shall order at least the quantity of supplies or services designated in the Schedule as the "minimum." (c) Except for any limitations on quantities in the Order Limitations clause or in the Schedule, there is no limit on the number of orders that may be issued. The Government may issue orders requiring delivery to multiple destinations or performance at multiple locations. (d) Any order issued during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the order. The contract shall govern the Contractor's and Government's rights and obligations with respect to that order to the same extent as if the order were completed during the contract's effective period; provided, that the Contractor shall not be required to make any deliveries under this contract after three (3) years from the date of award. FAR 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999) The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days. FAR 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998) This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The quoter is cautioned that the listed provisions may include blocks that must be completed by the quoter and submitted with its quotation. In lieu of submitting the full text of those provisions, the quoter may identify the provision by paragraph identifier and provide the appropriate information with its quotation. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):http://www.acquisition.gov/far/ and/or http://www.hhs.gov/policies/hhsar/. FAR 52.212-1 INSTRUCTION TO QUOTERS COMMERCIAL ITEMS (JAN 2017) FAR 52.212-3 QUOTERS REPRESENTATIONS AND CERTIFICATIONS - COMMERCIAL ITEMS (NOV 2017) FAR 52.212-4 CONTRACT TERMS AND CONDITIONS - COMMERCIAL ITEMS (JAN 2017) FAR 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS---COMMERCIAL ITEMS (JUL 2018) FAR 52.203-6 RESTRICTIONS ON SUBCONTRACTOR SALES TO THE GOVERNMENT (SEPT 2006), WITH ALTERNATE I (OCT 1995) FAR 52.204-10 REPORTING EXECUTIVE COMPENSATION AND FIRST-TIER SUBCONTRACT AWARDS (OCT 2016) FAR 52.209-6 PROTECTING THE GOVERNMENT'S INTEREST WHEN SUBCONTRACTING WITH CONTRACTORS DEBARRED, SUSPENDED, OR PROPOSED FOR DEBARMENT (OCT 2015) FAR 52.209-9 UPDATES OF PUBLICLY AVAILABLE INFORMATION REGARDING RESPONSIBILITY MATTERS (JUL 2013) FAR 52.216-19 ORDER LIMITATIONS (OCT 1995) During the contract period, the Government shall place orders totaling a minimum of 1,000 doses. This reflects the contract minimum for the entire period of performance, including any options. The contract maximum for the entire period of performance, including any options, shall be for the placement of orders totaling a maximum of 16,000 doses. FAR 52.217-5 EVALUATION OF OPTIONS (JUL 1990) FAR 52.219-4 NOTICE OF PRICE EVALUATION PREFERENCE FOR HUBZONE SMALL BUSINESS CONCERNS (OCT 2014) FAR 52.219-8 UTILIZATION OF SMALL BUSINESS CONCERNS (NOV 2016) FAR 52.219-9 SMALL BUSINESS SUBCONTRACTING PLAN (JAN 2017) FAR 52.222-19 CHILD LABOR-COOPERATION WITH AUTHORITIES AND REMEDIES (JAN 2018) FAR 52.222-21 PROHIBITION OF SEGREGATED FACILITIES (APR 2015) FAR 52.222-26 EQUAL OPPORTUNITY (SEPT 2016) FAR 52.222-35 EQUAL OPPORTUNITY FOR VETERANS (OCT 2015) FAR 52.222-36 EQUAL OPPORTUNITY FOR WORKERS WITH DISABILITIES (JUL 2014) FAR 52.222-37 EMPLOYMENT REPORTS ON VETERANS (FEB 2016) FAR 52.222-40 NOTIFICATION OF EMPLOYEE RIGHTS UNDER THE NATIONAL LABOR RELATIONS ACT (DEC 2010) FAR 52.222-50 COMBATING TRAFFICKING IN PERSONS (MAR 2015) FAR 52.223-18 ENCOURAGING CONTRACTOR POLICIES TO BAN TEXT MESSAGING WHILE DRIVING (AUG 2011) FAR 52.225-13 RESTRICTIONS ON CERTAIN FOREIGN PURCHASES (JUNE 2008) FAR 52.232-33 PAYMENT BY ELECTRONIC FUNDS TRANSFER-SYSTEM FOR AWARD MANAGEMENT (JUL 2013) HHSAR 352.203-70 ANITI - LOBBYING (DEC 2015) HHSAR 352.208-70 PRINTING AND DUPLICATION (DEC 2015) HHSAR 352.222-70 CONTRACTOR COOPERATION IN EQUAL EMPLOYMENT OPPORTUNITY INVESTIGATIONS. (DEC 2015) HHSAR 352.227-70 PUBLICATIONS AND PUBLICITY (DEC 2015) HHSAR 352.237-74 NON-DISCRIMINATION IN SERVICE DELIVERY (DEC 2015) Submission Information Quotes must stipulate that it is predicated upon all the terms and conditions of this RFQ, and signed by an official authorized to bind your organization. In addition, it must contain a statement to the effect that it is firm for a period of at least 30 days from the date of receipt thereof by the Government. **Quoters must complete (or attach) the pricing tables in section B.5 of the attached IDIQ Statement of Need (SON); and, section B.3 of the attached Delivery Order One Statement of Need (SON). Quotes must be submitted with a completed 52.212-3 Quoter Representations and Certifications-Commercial Items-with DUNS Number Addendum, signed by an authorized representative of the quoter OR provide a copy of valid certification in the System for Award Management (SAM) at www.sam.gov. Questions must be submitted electronically (via email) to Contracting Officer, Megan Kisamore, at megan.kisamore@nih.gov in MS Word or Adobe Portable Document Format (PDF), no later than 3:00 PM EST on Friday, July 20, 2018. Quotations must be submitted electronically (via email) to Contracting Officer, Megan Kisamore, at megan.kisamore@nih.gov in MS Word or Adobe Portable Document Format (PDF), no later than 3:00 PM EST, on Thursday, July 26, 2018. Please refer to solicitation no: N02CO82516-8 on all correspondence. This RFQ does not commit the Government to pay any of the costs associated with the preparation and submission of your quote. In addition, the Contracting Officer is the only individual authorized to legally commit the Government to the expenditure of public funds in connection with this requirement. By submitting a quote in response to this solicitation, it is understood that your quote shall become a part of the official contract file. Basis for Award / Evaluation The award shall be based on the responsible quoter that submits the Lowest Price Technically Acceptable (LPTA) quotation. A technically acceptable quote is one in which the quoter complies with the Statement of Work (SOW) and does not take exception, nor object to any of the terms of the RFQ. Quotes that are not technically acceptable will not be considered for award. The Government intends to evaluate quotations and make a single award without conducting "discussions" as defined in FAR Part 15. Therefore, the quoter's initial quote should contain the quoter's best terms from a price and technical standpoint. However, the Government reserves the right to contact the quoter (or multiple quoters) to request quotation revisions that seek additional price discounts, provide revisions to the technical quotation or explain other aspects of the quotation to improve the terms of the deal reflected in the quotation. In the event quotation revisions are requested, the Government will not necessarily be seeking revisions from all quoters. The Government may reject any or all quotes if such action is in the public interest; accept other than the lowest quote; and waive informalities and minor irregularities in quotes received.
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