Revised_Combined_Syn-Sol_Influenza_Vaccine__QUOTES_DUE_April_2,_2018.pdf

NIH-CC-18-005694

NATIONAL INSTITUTES OF HEALTH, CLINICAL CENTER,

Pharmacy Department

Influenza Vaccine Supply for the National Institutes of Health, Clinical Center

Combined Synopsis/Solicitation

March 20, 2018

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal

Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for

Commercial Items,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested, and a written solicitation document will not be issued.

The solicitation is being issued using simplified acquisition procedures under the authority of FAR 13.5 Test

Program for Certain Commercial Items.

The incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2005-96

(Effective 06 Nov 2017) (Class Deviation 2018-o0007).

This acquisition is set aside for Small Business only. Responses are due by 11:00 a.m. April 2, 2018

Only Small Businesses under the associated the associated North American Industrial Classification System

(NAICS) code are invited to submit quotes. The associated NAICS code for this procurement is 325412 with a small business size standard of 1250 employees (500 employees for distributors).

The National Institute of Health, Office of Purchasing and Contracts, is seeking to obtain a supply of flu vaccine, manufactured by a U.S. Flu vaccine manufacturer to fulfill the flu vaccine campaign for the next 60 months. Types of vaccine and quantities are listed in the pricing tables below.

Combined Synopsis/Solicitation NIH-CC-18-005694

Influenza Vaccine Supply for the National Institutes of Health, Clinical Center

The Government anticipates awarding a fixed price Indefinite Delivery/ Indefinite Quantity (IDIQ) Contract with economic price adjustment. Annual prices must be determined reasonable based on the market rate, current at the time of award. Types of vaccine, and quantity ordered are subject to change. Delivery Orders may be placed during any ordering period for delivery as far as seven (7) months after the expiration date of the Contract. Pre-negotiated separately priced line items may be purchased should there be additional need. The vaccine type is required to be consistent with previous orders during the same period of performance. Please see the Statement of Work (SOW) for details of the requirement.

Small Business Contractor must provide pricing within the following table for the summary of products with the salient characteristics, Brand Name or Equal, of the listed items and described in the following SOW.

* Prices shall be fully burdened to include all applicable excise taxes.

Line Item

Description of Vaccine Type (2018-2019 Season Vaccine)

*Unit Price

Unit Type

Quantity (estimate)

*Total ($)

Quadrivalent Influenza Vaccine 0.5 mL pre-filled syringes (Flucelvax, 10 syringes per box)

$_______ Box 2,200 $_______

High Dose Influenza Vaccine 0.5 mL pre-filled syringes(Fluzone High Dose, 10 syringes per box)

$_______ Box 150 $_______

Quadrivalent Pediatric Influenza Vaccine

0.25 mL pre-filled syringes (10 syringes per box)

$_______ Box 2 $_______

Quadrivalent Influenza Vaccine 0.5 mL single-dose vial (Fluzone, 10 single-dose vials per box)

$_______ Box 2 $_______

Quadrivalent Egg-free Influenza Vaccine without antibiotics, thimerosal, latex (Flublok Quadrivalent, 10 single dose vials per box)

$_______ Box 3 $_______

0006 Shipping (fixed price for entire order) $_______ Each 1 $_______

TOTAL including all Requested Items $_______

Line Item

Description of Vaccine Type (2019-2020 Season Vaccine)

Vaccine Type is dictated by the Flu Campaign, and is subject to change

*Unit Price

Unit Type

Quantity (estimate)

*Total ($)

Quadrivalent Influenza Vaccine 0.5 mL pre-filled syringes (Flucelvax, 10 syringes per box)

$_______ Box 2,200 $_______

High Dose Influenza Vaccine 0.5 mL pre-filled syringes(Fluzone High Dose, 10 syringes per box)

$_______ Box 150 $_______

Quadrivalent Pediatric Influenza Vaccine

0.25 mL pre-filled syringes (10 syringes per box)

$_______ Box 2 $_______

Quadrivalent Influenza Vaccine 0.5 mL single-dose vial (Fluzone, 10 single-dose vials per box)

$_______ Box 2 $_______

Quadrivalent Egg-free Influenza Vaccine without antibiotics, thimerosal, latex (Flublok Quadrivalent, 10 single dose vials per box)

$_______ Box 3 $_______

1006 Shipping (fixed price for entire order) $_______ Each 1 $_______

Description of Vaccine Type (2020-2021 Season Vaccine)

Vaccine Type is dictated by the Flu Campaign, and is subject to change

*Unit Price

Unit Type

Quantity (estimate)

*Total ($)

Quadrivalent Influenza Vaccine 0.5 mL pre-filled syringes (Flucelvax, 10 syringes per box)

$_______ Box 2,200 $_______

High Dose Influenza Vaccine 0.5 mL pre-filled syringes(Fluzone High Dose, 10 syringes per box)

$_______ Box 150 $_______

Quadrivalent Pediatric Influenza Vaccine

0.25 mL pre-filled syringes (10 syringes per box)

$_______ Box 2 $_______

Quadrivalent Influenza Vaccine 0.5 mL single-dose vial (Fluzone, 10 single-dose vials per box)

$_______ Box 2 $_______

Quadrivalent Egg-free Influenza Vaccine without antibiotics, thimerosal, latex (Flublok Quadrivalent, 10 single dose vials per box)

$_______ Box 3 $_______

2006 Shipping (fixed price for entire order) $_______ Each 1 $_______

Description of Vaccine Type (2022-2023 Season Vaccine)

Vaccine Type is dictated by the Flu Campaign, and is subject to change

*Unit Price

Unit Type

Quantity (estimate)

*Total ($)

Quadrivalent Influenza Vaccine 0.5 mL pre-filled syringes (Flucelvax, 10 syringes per box)

$_______ Box 2,200 $_______

High Dose Influenza Vaccine 0.5 mL pre-filled syringes(Fluzone High Dose, 10 syringes per box)

$_______ Box 150 $_______

Quadrivalent Pediatric Influenza Vaccine

0.25 mL pre-filled syringes (10 syringes per box)

$_______ Box 2 $_______

Quadrivalent Influenza Vaccine 0.5 mL single-dose vial (Fluzone, 10 single-dose vials per box)

$_______ Box 2 $_______

Quadrivalent Egg-free Influenza Vaccine without antibiotics, thimerosal, latex (Flublok Quadrivalent, 10 single dose vials per box)

$_______ Box 3 $_______

3006 Shipping (fixed price for entire order) $_______ Each 1 $_______

Description of Vaccine Type (2023-2024 Season Vaccine)

Vaccine Type is dictated by the Flu Campaign, and is subject to change

*Unit Price

Unit Type

Quantity (estimate)

*Total ($)

Quadrivalent Influenza Vaccine 0.5 mL pre-filled syringes (Flucelvax, 10 syringes per box)

$_______ Box 2,200 $_______

High Dose Influenza Vaccine 0.5 mL pre-filled syringes(Fluzone High Dose, 10 syringes per box)

$_______ Box 150 $_______

Quadrivalent Pediatric Influenza Vaccine

0.25 mL pre-filled syringes (10 syringes per box)

$_______ Box 2 $_______

Quadrivalent Influenza Vaccine 0.5 mL single-dose vial (Fluzone, 10 single-dose vials per box)

$_______ Box 2 $_______

Quadrivalent Egg-free Influenza Vaccine without antibiotics, thimerosal, latex (Flublok Quadrivalent, 10 single dose vials per box)

$_______ Box 3 $_______

4006 Shipping (fixed price for entire order) $_______ Each 1 $_______

Description of Vaccine Type (2024-2025 Season Vaccine)

Vaccine Type is dictated by the Flu Campaign, and is subject to change

*Unit Price

Unit Type

Quantity (estimate)

*Total ($)

Quadrivalent Influenza Vaccine 0.5 mL pre-filled syringes (Flucelvax, 10 syringes per box)

$_______ Box 2,200 $_______

High Dose Influenza Vaccine 0.5 mL pre-filled syringes(Fluzone High Dose, 10 syringes per box)

$_______ Box 150 $_______

Quadrivalent Pediatric Influenza Vaccine

0.25 mL pre-filled syringes (10 syringes per box)

$_______ Box 2 $_______

Quadrivalent Influenza Vaccine 0.5 mL single-dose vial (Fluzone, 10 single-dose vials per box)

$_______ Box 2 $_______

Quadrivalent Egg-free Influenza Vaccine without antibiotics, thimerosal, latex (Flublok Quadrivalent, 10 single dose vials per box)

$_______ Box 3 $_______

5006 Shipping (fixed price for entire order) $_______ Each 1 $_______

Proposals will be accepted in Microsoft Word or PDF form via e-mail at Lisa.Schaupp@nih.gov. E-mail proposals must be received at the e-mail inbox of Lisa.Schaupp@nih.gov by the date and time specified in the solicitation. Please note that faxed proposals are not acceptable and will be rejected.

Reference FAR clause 52.212-1(f) regarding timeliness of submission of offerors.

Scope of Work

Background

The mission of the National Institutes of Health (NIH) is to uncover new knowledge that will lead to better health for everyone. The NIH accomplishes that mission by conducting research in its own laboratories;

supporting the research of non-Federal scientists in universities, medical schools, hospitals, and research institutions throughout the country and abroad; helping in the training of research investigators; and fostering communication of biomedical information.

The NIH Clinical Center (CC) is a 200-bed federally funded, biomedical research hospital located on the NIH campus in Bethesda, Maryland. The Clinical Center is the delivery setting for all NIH intramural clinical research protocols. The hospital complex consists of two main facilities that are connected to each other by “bridges”. The original 14-story building is 2.5 million square feet and continues to house the clinical laboratories, imaging sciences, surgical suites, and several outpatient clinics. The new 870,000 square foot facility houses inpatient units and day hospitals. The Clinical Center accounts for about half of all NIH-funded clinical research beds in the United States and accommodates about 7,000 inpatient and 70,000 outpatient visits a year. Patients are admitted to the NIH Clinical Center from all over the world for the sole purpose of participating in a clinical research protocol.

The health, safety and welfare of all patients involved in NIH CC research protocols is the number one concern. The research mission would not be possible without the necessary safeguards in place. Our yearly flu vaccination campaign is one of those safeguards to ensure that our patients do not become infected from staff members. Flu vaccinations are mandatory for all employees and contractors that might come into contact with our patients. Our program starts in late August each year with the first wave of employees receiving the vaccine being those that provide direct patient care. Once those employees are vaccinated, the flu vaccine is offered to the entire campus.

Purpose

The purpose of this solicitation is to establish one source of supply for influenza vaccine that will provide the products listed in the schedule of supplies for purchase directly from the awarded contractor(s). The objective of such a contract is to ensure availability and consistency of product for NIH-wide usage and to obtain volume-based, committed use prices.

NIH intends to start each year’s Flu Vaccination Program in early September.

Products awarded under this contract are for use by the National Institutes of Health, Clinical Center, under the Health and Human Services Government agency and shall not be subject to resale for commercial purposes.

Scope

The NIH Clinical Center has a requirement to procure approximately 20,000 doses of flu vaccine each year for the NIH Vaccination Program. The type of influenza vaccine required may change as technology improves. The Contractor shall deliver the types of vaccine required in each Delivery Order. The following are the types of vaccines that are needed for the base year of this solicitation.

mailto:Lisa.Schaupp@nih.gov

Vaccine Type Est. Quantity, Unit Type

Quadrivalent Influenza Vaccine 0.5 mL pre-filled syringes

2,200 (Flucelvax, 10 syringes per box)

High Dose Influenza Vaccine 0.5 mL pre-filled syringes 150 (Fluzone High Dose, 10 syringes per box)

Quadrivalent Pediatric Influenza Vaccine 0.25 mL pre-filled syringes

2 (10 syringes per box)

Quadrivalent Influenza Vaccine 0.5 mL single-dose vial 2 (Fluzone, 10 single-dose vials per box)

Quadrivalent Egg-free Influenza Vaccine without antibiotics, thimerosal, latex

3 (Flublok Quadrivalent, 10 single dose vials per box)

Requirements

The vaccine must be purchased directly from the U.S. Manufacturer.

Delivery of the current to the season flu vaccine to occur by August 29th of each year.

Offerors shall provide a NDC number unique to the manufacturer for each item proposed by the solicitation prior to award. “Manufacturer” is defined as the entity that holds the biological license to cultivate, purify, and formulate the vaccine in accordance to FDA manufacturing standards. Offers that fail to provide this information by the solicitation closing date may be rejected and receive no further consideration. Please refer to the Scope of Contract and Instruction to Offerors sections of this solicitation.

Quantities

The estimated quantities listed in the solicitation reflect the estimated usage of The NIH Clinical Center.

There is no expressed or implied guarantee that the estimated quantities will be purchased under this contract. Actual quantities purchased may exceed or be less than those represented. Orders that specify the exact quantities and delivery locations will be placed by the NIH CC Pharmacy Department representative by the ordering deadline specified in the contract. The contractor must accept all delivery orders from the NIH Clinical Center that are received by the ordering deadline for quantities that are within the limitations specified in clause 52.216-19, Order Limitations. See also 52.216-18, Ordering.

Period of Performance

During any Contract ordering period, Influenza Vaccine may be ordered by issuance of Delivery/Task Orders for the current season or next season’s vaccine as pricing and ordering become available from the manufacturer. Task/delivery Orders may be issued up to ten months prior to the program’s required delivery date.

Base Award Ordering Period is estimated to be effective April 15, 2018 through April 14, 2019. .

Option Periods for ordering Flu Vaccine may be exercised by formal modification to the Contract.

Option Periods of Performance are estimated as follows.

Option Period One (1): April 15, 2019 through April 14, 2020 Option Period Two (2): April 15, 2020 through April 14, 2021 Option Period Three (3): April 15, 2021 through April 14, 2022 Option Period Four (4): April 15, 2022 through April 14, 2023

Packaging and Delivery

The vaccine shall be packaged in the manner recommended by the manufacturer for the type of vaccine being shipped.

Contractor shall deliver the current order of stated quantities of 2018-2019 season vaccines listed in the pricing table by August 29, 2018.

The delivery must be noted as an inside delivery to the address listed below.

NIH Campus, 9000 Rockville Pike Bethesda, MD. 20892 (Building and Room to be transmitted with award)

Inspection and Acceptance Criteria

The items listed in the scope of this document, must have been delivered in manufacturer recommended packaging and shipping methods, and must be received in full to be accepted as final by the Contracting Officer’s Representative (To be announced within the award) of the NIH Clinical Center.

(End Statement of Work)

PROVISIONS AND CLAUSES

CLAUSES INCORPORATED BY REFERENCE

52.212-4 Contract Terms and Conditions--Commercial Items Jan 2017

CLAUSES INCORPORATED BY FULL TEXT

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS--COMMERCIAL ITEMS

Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

Recalls. If a drug recall is initiated for any drug provided under this contract, regardless of whether it is a voluntary recall by the manufacturer or a recall required by the U.S. Food and Drug Administration (FDA); or, if FDA withdraws their approval to manufacture any drug that is included on this contract, the following action shall immediately be taken by the contractor:

Forward two copies of the recall notification along with any pertinent information to:

Chief of Procurement, Pharmacy Department

9000 Rockville Pike

Bethesda, MD 20892

(v) The non-FAR Part 12 discretionary FAR, and LOCAL clauses included herein are incorporated into this contract either by reference or in full text. If incorporated by reference, see clause 52.252-2 for locations where full text can be found.

CLAUSES INCORPORATED BY REFERENCE

52.202-1 Definitions NOV 2013

52.203-3 Gratuities APR 1984

52.203-5 Covenant Against Contingent Fees MAY 2014

52.203-6 Restrictions On Subcontractor Sales To The Government (Sep 2006)

Alternate 1

SEP 2006

52.203-7 Anti-Kickback Procedures MAY 2014

52.203-8 Cancellation, Rescission, And Recovery Of Funds For Illegal Or

Improper Activity

MAY 2014

52.203-10 Price Or Fee Adjustment For Illegal Or Improper Activity MAY 2014

52.203-12 Limitation On Payments To Influence Certain Federal Transactions OCT 2010

52.203-17 Contractor Employee Whistleblower Rights And Requirement To Inform

Employees Of Whistleblower Rights

APR 2014

52.203-98 Prohibition on Contracting with entities that Require Certain internal

Confidentiality agreements – Representation

FEB 2015

52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber Content Paper MAY 2011

52.204-9 Personal Identity Verification of Contractor Personnel JAN 2011

52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards JUL 2013

52.204-16 Commercial and Government Entity Code Reporting JUL 2016

52.204-18 Commercial And Government Entity Code Maintenance JUL 2016

52.209-5 Representation by corporations Regarding an Unpaid Tax Liability or a

Felony conviction Under Any Federal Law

OCT 2015

52.209-6 Protecting the Government's Interest When Subcontracting With

Contractors Debarred, Suspended, or Proposed for Debarment

AUG 2013

52.209-7 Information Regarding Responsibility Matters JUL 2013

52.219-6 Notice of Total Small Business Set Aside NOV 2011

52.222-55 Minimum Wages Under Executive Order 13658 DEC 2014

52.223-5 Pollution Prevention and Right-to-Know Information MAY 2011

52.223-6 Drug Free Workplace MAY 2001

52.229-3 Federal State and Local Taxes FEB 2013

52.232-1 Payments APR 1984

52.232-17 Interest MAY 2014

52.232-23 Assignment of Claims MAY 2014

52.232-39 Unenforceability of Unauthorized Obligations JUN 2013

52.233-3 Protest After Award AUG 1996

52.233-4 Applicable Law for Breach of Contract Claim OCT 2004

52.237-2 Protection Of Government Buildings, Equipment, And Vegetation APR 1984

52.237-3 Continuity of Services JAN 1991

52.242-13 Bankruptcy JUL 1995

52.242-15 Stop-Work Order AUG 1989

52.242-17 Government Delay Of Work APR 1984

52.245-1 Government Property APR 2012

52.245-9 Use And Charges APR 2012

52.253-1 Computer Generated Forms JAN 1991

352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations JAN 2010

352.223-70 Safety and Health JAN 2006

352.227-70 Publications and Publicity JAN 2006

352.231-71 Pricing Of Adjustments JAN 2001

352.242-73 Withholding of Contract Payments JAN 2006 352.270-7 Accessibility of Meetings, Conferences and Seminars to Persons with

Disabilities

JAN 2010

52.211-6 -- Brand Name or Equal (Aug 1999)

(a) If an item in this solicitation is identified as “brand name or equal,” the purchase description reflects the characteristics and level of quality that will satisfy the Government’s needs. The salient physical, functional, or performance characteristics that “equal” products must meet are specified in the solicitation.

(b) To be considered for award, offers of “equal” products, including “equal” products of the brand name manufacturer, must—

(1) Meet the salient physical, functional, or performance characteristic specified in this solicitation;

(2) Clearly identify the item by—

(i) Brand name, if any; and

(ii) Make or model number;

(3) Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and

(4) Clearly describe any modification the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modification.

(c) The Contracting Officer will evaluate “equal” products on the basis of information furnished by the offeror or identified in the offer and reasonably available to the Contracting Officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer.

(d) Unless the offeror clearly indicates in its offer that the product being offered is an “equal” product, the offeror shall provide the brand name product referenced in the solicitation.

(End of provision)

52.216-1 TYPE OF CONTRACT (APR 1984)

The Government contemplates awarding and indefinite quantity, indefinite delivery (IDIQ) type contract with economic price adjustment, standard supplies. Funding will not be obligated by the IDIQ Contract, only issued

Task/Delivery Orders obligate funds.

52.216-2 -- ECONOMIC PRICE ADJUSTMENT -- STANDARD SUPPLIES (JAN 1997)

(a) The Contractor warrants that the unit price stated in the Schedule for all Contract Line Items is not in excess of the Contractor’s applicable established price in effect on the contract date for like quantities of the same item. The term “unit price” excludes any part of the price directly resulting from requirements for preservation, packaging, or packing beyond standard commercial practice. The term “established price” means a price that --

(1) Is an established catalog or market price for a commercial item sold in substantial quantities to the general public; and

(2) Is the net price after applying any standard trade discounts offered by the Contractor.

(b) The Contractor shall promptly notify the Contracting Officer of the amount and effective date of each decrease in any applicable established price. Each corresponding contract unit price shall be decreased by the same percentage that the established price is decreased. The decrease shall apply to those items delivered on and after the effective date of the decrease in the Contractor’s established price, and this contract shall be modified accordingly.

(c) If the Contractor’s applicable established price is increased after the contract date, the corresponding contract unit price shall be increased, upon the Contractor’s written request to the Contracting Officer, by the same percentage that the established price is increased, and the contract shall be modified accordingly, subject to the following limitations:

(1) The aggregate of the increases in any contract unit price under this clause shall not exceed 10 percent of the original contract unit price.

(2) The increased contract unit price shall be effective --

(i) On the effective date of the increase in the applicable established price if the Contracting Officer receives the

Contractor’s written request within 10 days thereafter; or

(ii) If the written request is received later, on the date the Contracting Officer receives the request.

(3) The increased contract unit price shall not apply to quantities scheduled under the contract for delivery before the effective date of the increased contract unit price, unless failure to deliver before that date results from causes beyond the control and without the fault or negligence of the Contractor, within the meaning of the Default clause.

(4) No modification increasing a contract unit price shall be executed under this paragraph (c) until the Contracting

Officer verifies the increase in the applicable established price.

(5) Within 30 days after receipt of the Contractor’s written request, the Contracting Officer may cancel, without liability to either party, any undelivered portion of the contract items affected by the requested increase.

(d) During the time allowed for the cancellation provided for in subparagraph (c)(5) of this clause, and thereafter if there is no cancellation, the Contractor shall continue deliveries according to the contract delivery schedule, and the

Government shall pay for such deliveries at the contract unit price, increased to the extent provided by paragraph (c) of this clause.

(End of Clause)

52.216-18 ORDERING (OCT 1995)

(a) Any supplies and services to be furnished under this contract shall be ordered by issuance of delivery orders or task orders by the individuals or activities designated in the Schedule. Such orders may be issued from contract effective date through March 31, 2018.

(b) All delivery orders or task orders are subject to the terms and conditions of this contract. In the event of conflict between a delivery order or task order and this contract, the contract shall control.

(c) If mailed, a delivery order or task 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.

52.216-19 ORDER LIMITATIONS (OCT 1995)

(a) Minimum order. When the Government requires supplies or services covered by this contract in an amount of less than 1 box of 10, the Government is not obligated to purchase, nor is the Contractor obligated to furnish, those supplies or services under the contract.

(b) Maximum order. The Contractor is not obligated to honor—

(1) Any order for a single item in excess of 5,000 doses;

(2) Any order for a combination of items in excess of 100,000 doses; or

(3) A series of orders from the same ordering office within 3 days that together call for quantities exceeding the limitation in paragraph (b)(1) or (2) of this section.

(c) If this is a requirements contract (i.e., includes the Requirements clause at subsection 52.216-21 of the Federal

Acquisition Regulation (FAR)), the Government is not required to order a part of any one requirement from the

Contractor if that requirement exceeds the maximum-order limitations in paragraph (b) of this section.

(d) Notwithstanding paragraphs (b) and (c) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b), unless that order (or orders) is returned to the ordering office within 3 days after issuance, with written notice stating the Contractor's intent not to ship the item (or items) called for and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from another source.

52.217-6 -- Option for Increased Quantity (Mar 1989)

The Government may increase the quantity of supplies called for in the Schedule at the unit price specified. The

Contracting Officer may exercise the option by written notice to the Contractor within Period of Performance of the

Contract. Delivery of the added items shall continue at the same rate as the like items called for under the contract, unless the parties otherwise agree.

52.217-9 -- Option to Extend the Term of the Contract (Mar 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor any time prior to the expiration of the contract; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 60 months.

52.219-28 -- Post-Award Small Business Program Re-representation (Jul 2013)

(g) If the Contractor does not have representations and certifications in SAM, or does not have a representation in

SAM for the NAICS code applicable to this contract, the Contractor is required to complete the following re-representation and submit it to the contracting office, along with the contract number and the date on which the re-representation was completed:

The Contractor represents that it [ ] is, [ ] is not a small business concern under NAICS Code

_____________ assigned to contract number ______________________________.

[Contractor to sign and date and insert authorized signer's name and title].

52.222-40 Notification of Employee Rights Under the National Labor Relations Act (DEC 2010)

(a) During the term of this contract, the Contractor shall post an employee notice, of such size and in such form, and containing such content as prescribed by the Secretary of Labor, in conspicuous places in and about its plants and offices where employees covered by the National Labor Relations Act engage in activities relating to the performance of the contract, including all places where notices to employees are customarily posted both physically and electronically, in the languages employees speak, in accordance with 29 CFR 471.2(d) and (f).

(1) Physical posting of the employee notice shall be in conspicuous places in and about the Contractor's plants and offices so that the notice is prominent and readily seen by employees who are covered by the National Labor

Relations Act and engage in activities related to the performance of the contract.

(2) If the Contractor customarily posts notices to employees electronically, then the Contractor shall also post the required notice electronically by displaying prominently, on any Web site that is maintained by the Contractor and is customarily used for notices to employees about terms and conditions of employment, a link to the Department of

Labor's Web site that contains the full text of the poster. The link to the Department's Web site, as referenced in

(b)(3) of this section, must read, ``Important Notice about Employee Rights to Organize and Bargain Collectively with Their Employers.''

(b) This required employee notice, printed by the Department of Labor, may be--

(1) Obtained from the Division of Interpretations and Standards, Office of Labor-Management Standards, U.S.

Department of Labor, 200 Constitution Avenue, NW., Room N-5609, Washington, DC 20210, (202) 693-0123, or from any field office of the Office of Labor-Management Standards or Office of Federal Contract Compliance

Programs;

(2) Provided by the Federal contracting agency if requested;

(3) Downloaded from the Office of Labor-Management Standards Web site at http://www.dol.gov/olms/regs/compliance/EO13496.htm; or

(4) Reproduced and used as exact duplicate copies of the Department of Labor's official poster.

(c) The required text of the employee notice referred to in this clause is located at Appendix A, Subpart A, 29

CFR Part 471.

(d) The Contractor shall comply with all provisions of the employee notice and related rules, regulations, and orders of the Secretary of Labor.

(e) In the event that the Contractor does not comply with the requirements set forth in paragraphs (a) through (d) of this clause, this contract may be terminated or suspended in whole or in part, and the Contractor may be suspended or debarred in accordance with 29 CFR 471.14 and subpart 9.4. Such other sanctions or remedies may be imposed as are provided by 29 CFR part 471, which implements Executive Order 13496 or as otherwise provided by law.

(f) Subcontracts. (1) The Contractor shall include the substance of this clause, including this paragraph (f), in every subcontract that exceeds $10,000 and will be performed wholly or partially in the United States, unless exempted by the rules, regulations, or orders of the Secretary of Labor issued pursuant to section 3 of Executive

Order 13496 of January 30, 2009, so that such provisions will be binding upon each subcontractor.

(2) The Contractor shall not procure supplies or services in a way designed to avoid the applicability of Executive

Order 13496 or this clause.

(3) The Contractor shall take such action with respect to any such subcontract as may be directed by the Secretary of

Labor as a means of enforcing such provisions, including the imposition of sanctions for noncompliance.

(4) However, if the Contractor becomes involved in litigation with a subcontractor, or is threatened with such involvement, as a result of such direction, the Contractor may request the United States, through the Secretary of

Labor, to enter into such litigation to protect the interests of the United States.

(End of clause)

52.232-25 -- Prompt Payment (Jul 2013)

(a) Invoice payments—

(5) Computing penalty amount. The Government will compute the interest penalty in accordance with the

Office of Management and Budget prompt payment regulations at 5 CFR part 1315.

(i) For the sole purpose of computing an interest penalty that might be due the Contractor, Government acceptance is deemed to occur constructively on the 15th day (unless otherwise specified in this contract) after the Contractor delivers the supplies or performs the services in accordance with the terms and conditions of the contract, unless there is a disagreement over quantity, quality, or Contractor compliance with a contract provision. If actual acceptance occurs within the constructive acceptance period, the Government will base the determination of an interest penalty on the actual date of acceptance. The constructive acceptance requirement does not, however, compel Government officials to accept supplies or services, perform contract administration functions, or make payment prior to fulfilling their responsibilities.

52.252-2 -- Clauses Incorporated By Reference (Feb 1998)

This contract incorporates one or more clauses 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. Also, the full text of a clause may be accessed electronically at this/these address(es):

Regulations URLs: (Click on the appropriate regulation.)

http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/far1toc.htm

NOTE: After selecting the appropriate regulation above, at the "Table of Contents" page, conduct a search for the desired regulation reference using your browser's FIND function. When located, click on the regulation reference

(hyperlink).

52.252-6 AUTHORIZED DEVIATIONS IN CLAUSES (APR 1984)

(a) The use in this solicitation or contract of any Federal Acquisition Regulation (48 CFR Chapter 1) clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the date of the clause.

(b) The use in this solicitation or contract of any HHSAR FAR Supplement (48 CFR Chapter 3) clause with an authorized deviation is indicated by the addition of "(DEVIATION)" after the name of the regulation.

(End of clause)

INVOICE REQUIREMENTS

1) One invoice per delivered period (itemized)

2) Purchase Order number

3) Contractor DUNS number

4) Delivery Dates http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/far1toc.htm

5) Work performed

6) Total for entire invoice

A. The contractor shall submit the original and a copy of the invoices concurrently as follows:

a. An original mailed to the following designated payment office:

National Institutes of Health

Office of Financial Management

Commercial Accounts, Room 4B-432

2115 East Jefferson Street MSC 8500

Bethesda, Maryland 20892-8500

b. One copy e-mailed to the Contracting Officer’s Representative at:

National Institutes of Health

Department of Pharmacy

10 Center Dr, MSC 1196

Building 10, Room 1C166

Bethesda, Maryland 20892

Email: (To be announced at time of award)

(End of Addendum to 52.212-4)

PROVISIONS INCORPORATED BY REFERENCE

INSTRUCTIONS TO OFFERORS:

Addendum to FAR 52.212-1, Acceptance of Terms and Conditions

This is an Open-Market Combined Synopsis/Solicitation for supplies as defined herein. Offers will be reviewed exclusively based upon information submitted. If the information submitted does not address all the technical characteristics required in this combined solicitation-synopsis, the offer will be rejected. The Government intends to award a Fixed Price IDIQ Contract with Economic Price Adjustment as a result of this Combined

Synopsis/Solicitation that will include the terms and conditions that are set forth herein. In order to facilitate the award process, ALL offers shall include a statement regarding the terms and conditions herein as follows:

The offeror shall state “The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition.”

OR

The offeror shall state “The terms and conditions in the solicitation are acceptable to be included

In the award document with the exception, deletion, or addition of the following:

Offeror shall list exception(s) and rationale for the exception(s)

52.212-1 Instructions to Offerors--Commercial Items JAN 2017

Please note that this procurement is not being conducted under the GSA Federal Supply Schedule (FSS) program or another Government-Wide Area Contract (GWAC). If an offeror submits an offer based upon an FSS or GWAC contract, the Government will accept the quoted price. However, the terms and conditions stated herein will be included in any resultant Contract, not the terms and conditions of the offeror’s FSS or GWAC contract, and the statement required above shall be included in the offer.

(End of Addendum to FAR 52.212-1)

Addendum to FAR 52.212-1, Proposal Preparation Instructions

FAR 52.212-1 is hereby amended to reflect the changes shown below as to the specific paragraph revised.

Paragraph (b) Submission of Offers. The following amends this paragraph with respect to the information and documents required for submission in response to this solicitation.

(1) ELECTRONIC OFFERS. The offeror shall submit electronic offers in response to this solicitation unless otherwise specified herein. The offer must arrive by the time specified in the solicitation to the following email address: Lisa.Schaupp@nih.gov .

(2) PROCESS FOR AWARD. Award will be made to the Best Value Offeror consistent with the evaluation criteria discussed at FAR 52.212-2 and Addendum to FAR 52.212-2.

a) Selection of an offeror for contract award will be based on an evaluation of proposals against three factors.

The factors in order of importance are: technical, price, and past performance. Although technical factors are of paramount consideration in the award of the contract, both past performance and cost/price are also important to the overall contract award decision. All evaluation factors other than cost or price, when combined, are significantly more important than cost or price. The Government intends to make an award to that offeror whose proposal provides the best overall value to the Government.

b) Offerors are advised that award will be made to that offeror whose proposal provides the combination of features that offers the best or greatest overall value to the Government. The Government is more concerned with obtaining performance capability superiority rather than lowest overall cost. However, the Government will not make an award at a significantly higher overall cost to the Government to achieve only slightly superior performance. Overall cost to the Government may become a significant determining factor for award of a contract as proposals become more equal based on the other factors. In any event the Government reserves the right to make an award to the best advantage of the Government, cost and other factors considered.

c) The evaluation will be based on the demonstrated capabilities of the prospective Contractors in relation to the needs of the project as set forth in the RFP. The merits of each proposal will be evaluated carefully. Each proposal must document the feasibility of successful implementation of the requirements of the RFP. Offerors must submit information sufficient to evaluate their proposals based on the detailed criteria provided in the solicitation.

(3) BASIS FOR AWARD. Award will be made to the offeror that proposes: a technical proposal conforming to the requirements of the solicitation; has an acceptable record of past performance; its price is determined to be fair and reasonable by the contracting officer; and the contracting officer determines the offeror is responsible in accordance with FAR Part 9. The Contracting Officer intends to award without discussions, but reserves the right to do so in his or her sole discretion.

(4) The Government may reject a proposal if it is found that any information that has a negative impact on the offeror's past performance record has been deleted, misrepresented, or withheld.

(5) Offers shall remain valid for a period of 90 days from the date offers are due.

(6) Quotation shall include Certifications and Representations, Technical, Past Performance, and Price as separate parts in the submission.

CERTIFICATIONS & REPRESENTATIONS:

Provide pricing for each Contract Line Item Numbers (CLINS).

52.212-3 - Offeror Representations and Certifications -- Commercial Items(MAR 2015)

Proof of sourcing from U.S. Manufacturer

QUOTATION COMPOSITION:

PART I: TECHNICAL

FACTOR 1: TECHNICAL CAPABILITY - The offeror shall provide sufficient information to demonstrate its understanding of the requirements, providing a concise, detailed, and thorough discussion of its technical capability to successfully provide the equipment and services as required in this solicitation.

The offeror shall submit with their proposal:

Proof of sourcing the vaccines from a U.S. Manufacturer must be provided.

Offerors shall provide an NDC number unique to the manufacturer for each item proposed by the solicitation prior to award.

Past Performance information on at least two recent and relevant contracts.

Guarantee delivery of product in manufacturer recommended condition and packaging.

Proof of ability to provide the newest and most effective influenza vaccine for every season in the pricing table

Pricing must be provided for each Contract Line Item Number (CLIN).

Submissions shall meet, at least, the criteria described in the Statement of Work above.

PART II: PAST PERFORMANCE.

Offerors shall submit past performance information on at least two (2) but not more than four (4) recent and relevant contracts (within the past three years from the date of the solicitation). If more than four contract references are submitted, only the first four will be evaluated. References may include performance on contracts for Federal, State and local Governments as well as private commercial firms of similar size and scope.

Section 1 – Contract Description Information:

Offeror’s CAGE Code and DUNS Number. Point of Contact (POC) (name, and current address, e-mail address, and telephone and fax numbers). Contracting activity/Administration and current address, Contracting Officer or

Technical Representative Name, e-mail address, telephone and fax numbers. Contract Number and, in the case of

Indefinite Delivery type contracts, GSA contracts, and Blanket Purchase Agreements, include Delivery Order

Numbers also; Awarded price; Final or projected final price; Original/Final delivery schedule, including dates of start and completion of delivery.

Section 2 – Performance (See FAR Provision 52.212-2 Addendum Government intends to evaluate.)

Offerors shall provide a specific narrative explanation of each contract listed in Section 1 above describing recency and relevancy of the requirements in this solicitation.

For any contracts that did not/do not meet original schedule or technical performance requirements, provide a brief explanation of the reason(s) for the shortcomings and any corrective action(s) taken to avoid recurrence. The

Offerors shall indicate if any of the contracts listed were terminated and the type and reasons for the termination.

PART III: PRICE.

Offerors shall provide pricing for all item/s specified on each Contract Line Item Number (CLIN) of the solicitation.

Para (g) Contract award. This paragraph is amended to state that the Government may conduct discussions prior to contract award.

Para (j) Data Universal Numbering System (DUNS)/CAGE Code. This paragraph is amended to state that the offeror shall obtain these Codes and include them in the proposal and confirm Registration in System for Award

Management and the Online Representations and Certifications, if you are a US firm. Award cannot and shall not be made to an offeror without these codes.

Para (m) Proposal Preparation Costs. This solicitation does not commit the Government to pay any costs incurred in the submission of an offer, in making any necessary studies for the preparation thereof, or for any visit(s) the

Contracting Officer may request for the purpose of clarification of the offer.

Para (n) The offeror is responsible for ensuring that its proposal is complete. The proposal shall be clear, concise, and shall include sufficient detail for effective evaluation and for substantiating the validity of any stated claims.

The proposal shall not simply rephrase or restate the Government's requirements, but rather shall provide convincing rationale to address how the offeror intends to perform the requirement. The offeror shall assume that the

Government has no prior knowledge of their experience and will base its evaluation solely on the information presented in the offeror's proposal.

Para (o) Protests received at a level higher than the contracting officer will be referred to the contracting officer.

Protestor may request a review by the contracting officer or an independent review at a level higher than the contracting officer. Requests for appeals or independent review will be addressed to the contracting officer for referral to the review authority. Questions on this process will be referred to the cognizant contracting officer identified in the solicitation.

Para (p) The non-FAR Part 12 discretionary FAR, and LOCAL provisions included herein are incorporated into this solicitation either by reference or in full text. If incorporated by reference, see provision 52.252-1 herein for locations where full text can be found.

(End of Addendum to FAR 52.212-1)

52.212-2 EVALUATION--COMMERCIAL ITEMS (OCT 2014)

(a) The Government will award a contract(s) resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

1. The offered line items must fully meet the product description, to include, the vaccine name, strength(s), and package size(s), as stated in the Schedule of Supplies.

2. The National Drug Code (NDC) number of the offered product must be unique to the manufacturer.

3. The Manufacturing Facility/Place of Performance must be FDA cGMP acceptable.

4. Offered line items must have a shelf life (expiration date) of no less than 9 months

See Addendum to 52.212-2

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

(c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(End of provision)

ADDENDUM TO 52.212-2

Paragraph (a) is hereby supplemented with the following:

The Government will award a contract resulting from this solicitation to the responsible Offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered.

Award will be made using the best value source selection process.

Except for communications conducted for the purpose of minor clarification, the Government intends to evaluate the proposal and award a contract without discussions.

In the evaluation of all Offerors’ proposals, appropriate consideration is given to three (3) evaluation factors:

Technical, Past Performance and Price are in descending order of importance. Technical is more important than past performance. Technical and Past Performance, when combined, are significantly more important than Price. The importance of price in the evaluation will increase with the degree of equality among quotations of the non-price factors.

To receive consideration for award, a rating of no less than “ACCEPTABLE” must be achieved for the technical capability evaluation factor. For Past Performance, the offeror must receive a rating of no less than

‘SATISFACTORY confidence’ to be considered for award. However, offerors which receive an unknown

(neutral) past performance rating will be considered for award.

EVALUATION FACTORS -- THE FOLLOWING FACTORS WILL BE EVALUATED:

PART I: TECHNICAL

Factor 1: Technical Capability reflects the Government’s confidence in the offeror’s ability, as demonstrated in its proposal, to perform the requirements as stated in this Solicitation.

The following adjectival ratings will be used in evaluating each offeror’s technical proposal.

Color Rating Description

Blue Outstanding

Proposal meets requirements and indicates an exceptional approach and understanding of the requirements. Strengths far outweigh any weaknesses. Risk of unsuccessful performance is very low.

Purple Good

Proposal meets requirements and indicates a thorough approach and understanding of the requirements. Proposal contains strengths which outweigh any weaknesses. Risk of unsuccessful performance is low.

Green Acceptable

Proposal meets requirements and indicates an adequate approach and understanding of the requirements. Strengths and weaknesses are offsetting or will have little or no impact on contract performance. Risk of unsuccessful performance is no worse than moderate.

Yellow Marginal

Proposal does not clearly meet requirements and has not demonstrated an adequate approach and understanding of the requirements. The proposal has one or more weaknesses which are not offset by strengths. Risk of unsuccessful performance is high.

Red Unacceptable…