Offer_Submission_Package__for_15-100-SOL-00003.pdf

Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response

Acquisition Management Contracts and Grants

Request for Proposal

15-100-SOL-00003

Offer Submission Package

Medical Countermeasures for Pandemic Influenza Preparedness and Response

Period of Performance: September 1, 2015 through August 31, 2018 + Two 12-month option periods

Issue Date: January 12, 2015 Proposals Due: February , 20, 2015, 5:00 PM EST To be timely offers must be received by the date and time indicated above.

Provision/Clause Title Page Number(s)

Section A – Solicitation/Contract Form

Standard Form 1447 3

No response Notice (back of SF 1447) 4

Section B - Supplies or Services and Price/Costs

Contract Line Item Numbers(CLINs) and Prices 5-14

Turnaround Time 15

Schedule of Labor Category Hourly Rates 17

Analytical Laboratory Testing Assay – Pricing per Time Point 17

Section K-Representations, Certifications, and Other Statements of Offerors

Product Licensure 18

Contractor’s CAGE Code, DUNS, and TIN 18

Hubzone Evaluation Preference 18-20

Trade Agreements Certificate 21

Online Representations and Certifications 21

15-100-SOL-00003 Offer Submission Package

SOLICITATION/CONTRACT

BIDDER/OFFEROR TO COMPLETE BLOCKS 11, 13, 15, 21, 22, & 27

1. THIS CONTRACT IS A RATED

ORDER UNDER DPAS (15 CFR 700)

RATING PAGE OF PAGES

2. CONTRACT NO. 3. AWARD/

EFFECTIVE DATE

4. SOLICITATION NUMBER

15-100-SOL-00003

5. SOLICITATION TYPE

SEALED BIDS x NEGOTIATED

(IFB) (RFP)

6. SOLICITATION

ISSUE DATE

7. ISSUED BY CODE HHS/OS/ASPR/BARDA 8. THIS ACQUISITION IS X UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS WOMEN-OWNED SMALL BUSINESS (WOSB)

HUBZONE SMALL ELIGIBLE UNDER THE WOSB PROGRAM

BUSINESS EDWOSB

SERVICE-DISABLED VETERAN-

OWNED SMALL BUSINESS NAICS: 325414

8(A) SIZE STANDARD: 500

HHS/OS/ASPR/BARDA

330 Independence Ave., S.W.

Room 640-G Washington DC 20201

NO COLLECT CALLS9. (AGENCY USE)

10. ITEMS TO BE PURCHASED (BRIEF DESCRIPTION)

SUPPLIES SERVICES

11. IF OFFER IS ACCEPTED BY THE GOVERNMENT WITHIN

CALENDAR DAYS (60 CALENDAR DAYS UNLESS OFFEROR INSERTS A DIFFERENT

12. ADMINISTERED BY

ASPR-BARDA

CODE

ASPR-BARDA01

PERIOD) FROM THE DATE SET FORTH IN BLOCK 9 ABOVE, THE CONTRACTOR

AGREES TO HOLD ITS OFFERED PRICES FIRM FOR THE ITEMS SOLICITED

HEREIN AND TO ACCEPT ANY RESULTING CONTRACT SUBJECT TO THE TERMS

AND CONDITIONS STATED HEREIN.

330 Independence Ave, SW, Rm G644

Washington DC 20201

13. CONTRACTOR CODE FACILITY 14. PAYMENT WILL BE MADE BY CODE

OFFEROR CODE

TELEPHONE NO.

DUNS NO.

CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK:

15. PROMPT PAYMENT DISCOUNT 16. AUTHORITY FOR USING OTHER

THAN FULL AND OPEN COMPETITION

10 U.S.C. 2304 41 U.S.C. 253

17.

ITEM NO.

18.

SCHEDULE OF SUPPLIES/SERVICES

19.

QUANTITY

20.

UNIT

21.

UNIT PRICE

22.

AMOUNT

Medical Countermeasures (MCMs) for Pandemic Influenza Preparedness and Response

PoP: September 1, 2015 through August 31, 2018 + Two 12-month option periods

23. ACCOUNTING AND APPROPRIATION DATA 24. TOTAL AWARD AMOUNT

(FOR GOVERNMENT USE ONLY)

25. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN 4 COPIES TO 26. AWARD OF CONTRACT: YOUR OFFER ON SOLICITATION

ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER ALL ITEMS SET

x FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY CONTINUATION SHEETS

SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED HEREIN.

NUMBER SHOWN IN BLOCK 4 INCLUDING ANY ADDITIONS

OR CHANGES WHICH ARE SET FORTH HEREIN, IS

ACCEPTED AS TO ITEMS:

27. SIGNATURE OF OFFEROR/CONTACTOR 28. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

NAME AND TITLE OF SIGNER (TYPE OR PRINT) DATE SIGNED NAME OF CONTRACTING OFFICER DATE SIGNED

LYNDA M. BROWN

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION NOT USABLE

STANDARD FORM 1447 (REV. 2/2012)

Prescribed by GSA - FAR (48 CFR) 53.214(d)

Offer Submission Package

PAGE OF

NO RESPONSE FOR REASONS CHECKED

CANNOT COMPLY WITH SPECIFICATIONS CANNOT MEET DELIVERY REQUIREMENT

UNABLE TO IDENTIFY THE ITEM(S) DO NOT REGULARLY MANUFACTURE OR SELL THE TYPE OF ITEMS INVOLVED

OTHER (Specify)

WE DO WE DO NOT, DESIRE TO BE RETAINED ON THE MAILING LIST FOR FUTURE PROCUREMENT OF THE TYPE OF ITEMS INVOLVED

NAME AND ADDRESS OF FIRM (Include ZIP Code) SIGNATURE

TYPE OR PRINT NAME AND TITLE OF SIGNER

FROM: AFFIX

STAMP

HERE

TO:

HHS/OS/ASPR/BARDA

HHS/OS/ASPR/BARDA

330 Independence Ave., S.W. Room

640-G

Washington DC 20201

15-100-SOL-00003

SOLICITATION NO.

DATE AND LOCAL TIME

15-100-SOL-00003 Offer Submission Package

Section B – Supplies or Services and Price/Costs

B.1. The Statement of Work (SOW) contained in Section C of the solicitation package delineates the specifics of the supplies or services to be furnished. The minimum guarantee is $500,000.00 for the duration of any resultant contract (base + options).

Provide firm-fixed prices for all CLINs, except those CLINs which have “TBD” or “N/A” in the

Estimated Maximum Quantity column. Provide pricing based upon the CLIN, item name and description in the SOW contained in Section C for the three (3) year base period, and item name and description for the two 12-month option periods, as the numbers in SOW reflect base period numbering (SOW

Numbering identified in SOW would be revised in conjunction with any resultant option award with description data unchanged).

Price/Cost, e.g., Firm-fixed-price or cost reimbursable, for “TBD” CLINs, i.e., 0007F, 0008, 0010, 0011, 0012, 0013, 0014, and 0015 will be determined as a result of the issuance of a Request for Task Order

Response (RTOR) to any or all resultant contract awardee(s).

B.2. Contract Line Item Numbers (CLINs) and Pricing:

a. Base Period: September 1, 2015 through August 31, 2018

CLIN Item Name Unit of Issue Estimated

Maximum

Quantity

Unit Price Estimated Dollar

Value Per 12-month

Total

Estimated

Dollar Value

(36 Month

Base Period)

0001 cGMP Influenza

Vaccine Master and Working Seed

Lot

Seed

Lot

0002 Influenza Vaccine

Development

Lot(s)

Development

Lot

0003 cGMP Influenza

Vaccine Clinical

Lot(s)

Clinical Lot 15

0004 cGMP Influenza

Vaccine

Commercial Scale

Bulk Lot(s)

Bulk Lot 300

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0005 cGMP Adjuvant

Commercial Scale

Bulk Lot(s)

Bulk Lot 50

0006A Formulation and

Filling:

Antigen-Singe dose vials

Each 10,000,000

0006B Formulation and

Filling:

Antigen-Syringes or Sprayers

Each 100,000,000

0006C Formulation and

Filling:

Antigen-Multi-dose vials

Each 10,000,000

0006D Formulation and

Filling:

Adjuvant-Single dose vials

Each 100,000,000

0006E Formulation and

Filling:

Adjuvant-Multi-dose vials

Each 10,000,000

0006F Formulation and

Filling: Co-formulated antigen and adjuvant-

Single dose vials

Each 10,000,000

0006G Formulation and

Filling: Co-formulated antigen and adjuvant-

Syringes

Each 100,000,000

0006H Formulation and

Filling: Co-formulated antigen and adjuvant-

Multi-dose vials

Each 10,000,000

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0007A Storage and

Stability:

Storage of Clinical

Bulk Lots of

Antigen

Lot 20

Per Lot

Per month

Per lot/12 months

20 Lots/12 months

0007B Storage and

Stability: Storage of Commercial

Bulk Lots of

Antigen

Lot 100

Per Lot

Per month

Per Lot/12 months

100 Lots/12 months

0007C Storage and

Stability: Storage of Antigen in Final

Container

Final

Container

5,000,000

Per FC

Per Month

Per FC/12 months

5,000,000 FC/12

months

0007D Storage and

Stability: Storage of Adjuvant bulk lots

Lot 400

Per Lot

Per Month

Per Lot/12 months

400 Lots/12 months

0007E Storage and

Stability: Storage of Adjuvant in

Final Container

Final

Container

5,000,000

Per FC

Per Month

Per FC/12 months

5,000,000 FC/12

months

0007F Storage and

Stability: Storage of licensed product

Package TBD

Per PG

Per Month

Per PG/12 month

0008 Shipping Each TBD

0009 Candidate Vaccine

Virus (C V V)

Each 15

0010 Potency Reagent and Standards

Manufacture and

Testing

Each TBD

15-100-SOL-00003

Laboratory

Testing/Assay

Each TBD

0012 Animal Studies Study TBD

0013 Clinical Studies Study TBD

0014 Disposal of

Product

Each TBD

0015 BARDA Tracking

Tool-Development and Testing of

New Standard

Data Reporting

Formats

Each TBD

0016 Additional

Reporting

Report N/A

Total Estimated Dollar Amount - Base Period

b. Option Period One: September 1, 2018 through August 31, 2019

CLIN Item Name Unit of Issue Estimated

Maximum

Quantity

Unit Price Total Estimated

Dollar Value

0101 cGMP Influenza

Vaccine Master and Working Seed

Lot

Seed

Lot

0201 Influenza Vaccine

Development

Lot(s)

Development

Lot

0301 cGMP Influenza

Vaccine Clinical

Lot(s)

Clinical Lot 5

15-100-SOL-00003

0401 cGMP Influenza

Vaccine

Commercial Scale

Bulk Lot(s)

Bulk Lot 100

0501 cGMP Adjuvant

Commercial Scale

Bulk Lot(s)

Bulk Lot 20

0601A Formulation and

Filling:

Antigen-Singe dose vials

Each 10,000,000

0601B Formulation and

Filling:

Antigen-Syringes or Sprayers

Each 100,000,000

0601C Formulation and

Filling:

Antigen-Multi-dose vials

Each 10,000,000

0601D Formulation and

Filling:

Adjuvant-Single dose vials

Each 100,000,000

0601E Formulation and

Filling:

Adjuvant-Multi-dose vials

Each 10,000,000

0601F Formulation and

Filling: Co-formulated antigen and adjuvant-

Single dose vials

Each 10,000,000

0601G Formulation and

Filling: Co-formulated antigen and adjuvant-

Syringes

Each 100,000,000

15-100-SOL-00003

0601H Formulation and

Filling: Co-formulated antigen and adjuvant-

Multi-dose vials

Each 10,000,000

0701A Storage and

Stability:

Storage of Clinical

Bulk Lots of

Antigen

Lot 7

0701B Storage and

Stability: Storage of Commercial

Bulk Lots of

Antigen

Lot 30

0701C Storage and

Stability: Storage of Antigen in Final

Container

Final

Container

5,000,000

0701D Storage and

Stability: Storage of Adjuvant bulk lots

Lot 30

0701E Storage and

Stability: Storage of Adjuvant in

Final Container

Final

Container

5,000,000

0701F Storage and

Stability: Storage of licensed product

Package TBD

0801 Shipping Each TBD

0901 Candidate Vaccine

Virus (C V V)

Each 5

1001 Potency Reagent and Standards

Manufacture and

Testing

Each TBD

15-100-SOL-00003

1101 Laboratory

Testing/Assay

Each TBD

1201 Animal Studies Study TBD

1301 Clinical Studies Study TBD

1401 Disposal of

Product

Each TBD

1501 BARDA Tracking

Tool-Development and Testing of

New Standard

Data Reporting

Formats

Each TBD

1601 Additional

Reporting

Report

Total Estimated Dollar Amount – Option Period One

c. Option Period Two: September 1, 2019 through August 31, 2020

CLIN Item Name Unit of Issue Estimated

Maximum

Quantity

Unit Price Total Estimated

Dollar Value

(36 Month Base

Period)

1701 cGMP Influenza

Vaccine Master and Working Seed

Lot

Seed

Lot

1801 Influenza Vaccine

Development

Lot(s)

Development

Lot

1901 cGMP Influenza

Vaccine Clinical

Lot(s)

Clinical Lot 5

15-100-SOL-00003

2001 cGMP Influenza

Vaccine

Commercial Scale

Bulk Lot(s)

Bulk Lot 100

2101 cGMP Adjuvant

Commercial Scale

Bulk Lot(s)

Bulk Lot 20

2201A Formulation and

Filling:

Antigen-Singe dose vials

Each 10,000,000

2201B Formulation and

Filling:

Antigen-Syringes or Sprayers

Each 100,000,000

2201C Formulation and

Filling:

Antigen-Multi-dose vials

Each 10,000,000

2201D Formulation and

Filling:

Adjuvant-Single dose vials

Each 100,000,000

2201E Formulation and

Filling:

Adjuvant-Multi-dose vials

Each 10,000,000

2201F Formulation and

Filling: Co-formulated antigen and adjuvant-

Single dose vials

Each 10,000,000

2201G Formulation and

Filling: Co-formulated antigen and adjuvant-

Syringes

Each 100,000,000

15-100-SOL-00003

2201H Formulation and

Filling: Co-formulated antigen and adjuvant-

Multi-dose vials

Each 10,000,000

2301A Storage and

Stability:

Storage of Clinical

Bulk Lots of

Antigen

Lot 7

2301B Storage and

Stability: Storage of Commercial

Bulk Lots of

Antigen

Lot 30

2301C Storage and

Stability: Storage of Antigen in Final

Container

Final

Container

5,000,000

2301D Storage and

Stability: Storage of Adjuvant bulk lots

Lot 30

2301E Storage and

Stability: Storage of Adjuvant in

Final Container

Final

Container

5,000,000

2301F Storage and

Stability: Storage of licensed product

Package TBD

2401 Shipping Each TBD

2501 Candidate Vaccine

Virus (C V V)

Each 5

2601 Potency Reagent and Standards

Manufacture and

Testing

Each TBD

15-100-SOL-00003

2701 Laboratory

Testing/Assay

Each TBD

2801 Animal Studies Study TBD

2901 Clinical Studies Study TBD

3001 Disposal of

Product

Each TBD

3101 BARDA Tracking

Tool-Development and Testing of

New Standard

Data Reporting

Formats

Each TBD

3201 Additional

Reporting

Report N/A

Total Estimated Dollar Amount – Option Period Two

15-100-SOL-00003

B.3. Turnaround Time

Identify turnaround time/lead time from date of order to completion/delivery required by contractor for U/I and to reach maximum manufacturing production that vendor would be able to provide U.S. Government in event of a pandemic (identify maximum production capacity).

CLIN Item Name Unit of Issue Number of

Days/Lead

Time from date of Order to Delivery per U/I

Maximum

Quantity vendor could produce in event of pandemic

Number of

Days Needed from date of

Order to

Delivery per

Maximum

Quantity

0001 cGMP Influenza

Vaccine Master and

Working Seed Lot

Seed

Lot

0002 Influenza Vaccine

Development Lot(s)

Development

Lot

0003 cGMP Influenza

Vaccine Clinical

Lot(s)

Clinical Lot

0004 cGMP Influenza

Vaccine Commercial

Scale Bulk Lot(s)

Bulk Lot

0005 cGMP Adjuvant

Commercial Scale

Bulk Lot(s)

Bulk Lot

0006A Formulation and

Filling:

Antigen-Singe dose vials

Each

0006B Formulation and

Filling:

Antigen-Syringes or

Sprayers

Each

0006C Formulation and

Filling:

Antigen-Multi-dose vials

Each

15-100-SOL-00003

0006D Formulation and

Filling:

Adjuvant-Single dose vials

Each

0006E Formulation and

Filling:

Adjuvant-Multi-dose vials

Each

0006F Formulation and

Filling: Co-formulated antigen and adjuvant-Single dose vials

Each

0006G Formulation and

Filling: Co-formulated antigen and adjuvant-Syringes

Each

0006H Formulation and

Filling: Co-formulated antigen and adjuvant-Multi-dose vials

Each

15-100-SOL-00003

B.4. Schedule of Labor Category Hourly Rates for TBD CLINs

Offerors should provide a table of position titles, description of the education level attained and years of relevant experience, and hourly rates. Responses to unpriced CLINs will rely on these tables to evaluate proposed costs. For example:

Position Description Hourly Rate

QA-1 B, 3+ years $

QA-2 B, 6+ years; M, 3+ years $

QA-Manager B, 18+ years; M, 12+ years; D, 6+ years $

QA-Director D, 16+ years $

QA-VP D, 20+ years $

Technician-1 H, 6+ years $

H: High School; B: Bachelor; M: Master; D: Doctor

Offerors should provide over-head rates specific to the facilities offered.

B.5. Analytical Laboratory Testing/Assay-CLIN0011—Pricing per Time Point

Offerors shall provide pricing for below indicated time points:

Perform stability testing and/or other testing: SRID, HPLC, SDS-Page and Western Blot

Test Methods SRID HPLC SDS-Page Western Blot

Time Points 2-8°C

Time Zero

3 months

6 months

9 months

12 months

18 months

24 months

15-100-SOL-00003

Section K-Representations, Certifications and Other Statements of

Offerors

K.1. PRODUCT LICENSURE

1. The influenza vaccines purchased, stored and distributed under this contract shall be manufactured under a current establishment and product licensure issued by the Food and Drug

Administration. Offeror shall indicate number below:

Name of Vaccine (as applicable):

License Number (s) (as applicable:

2. The Contractor agrees to comply with cGMP guidelines (21 CFR Parts 210-211, 600) for manufacturing, processing and packing of drugs, chemicals, biological and reagents.

3. The Contractor agrees to advise the CO and COR immediately of any relocation of their prime manufacturing facility or the relocation of any subcontractor’s facility. Contractor also agrees to advise the CO and COR immediately if at any time during the life of the contract, the items listed under this contract fail to comply with cGMP guidelines and/or the facility receives a negative

FDA Quality Assurance Evaluation (Form 483).

K.2. Contractor’s CAGE Code, DUNS, and TIN

CAGE Code: __________________ DUNS: _____________________

(Otherwise insert CAGE Code in Block 13 of SF 1447)

TIN: ____________________

K.3. Hubzone Evaluation Preference

52.219-4 -- Notice of Price Evaluation for HUBZone Small Business Concerns (Oct 2014)

(a) Definition. See 13 CFR 125.6(e) for definitions of terms used in paragraph (d).

(b) Evaluation preference.

(1) Offers will be evaluated by adding a factor of 10 percent to the price of all offers, except—

15-100-SOL-00003

(i) Offers from HUBZone small business concerns that have not waived the evaluation preference; and

(ii) Otherwise successful offers from small business concerns.

(2) The factor of 10 percent shall be applied on a line item basis or to any group of items on which award may be made. Other evaluation factors described in the solicitation shall be applied before application of the factor.

(3) When the two highest rated offerors are a HUBZone small business concern and a large business, and the evaluated offer of the HUBZone small business concern is equal to the evaluated offer of the large business after considering the price evaluation preference, award will be made to the HUBZone small business concern.

(c) Waiver of evaluation preference. A HUBZone small business concern may elect to waive the evaluation preference, in which case the factor will be added to its offer for evaluation purposes.

The agreements in paragraphs (d) and (e) of this clause do not apply if the offeror has waived the evaluation preference.

__ Offer elects to waive the evaluation preference.

(d) Agreement. A HUBZone small business concern agrees that in the performance of the contract, in the case of a contract for

(1) Services (except construction), at least 50 percent of the cost of personnel for contract performance will be spent for employees of the concern or employees of other HUBZone small business concerns;

(2) Supplies (other than procurement from a nonmanufacturer of such supplies), at least

50 percent of the cost of manufacturing, excluding the cost of materials, will be performed by the concern or other HUBZone small business concerns;

(3) General construction.

(i) At least 15 percent of the cost of contract performance to be incurred for personnel will be spent on the prime contractor’s employees;

(ii) At least 50 percent of the cost of the contract performance to be incurred for personnel will be spent on the prime contractor’s employees or on a combination of the prime contractor’s employees and employees of HUBZone small business concern subcontractors;

(iii) No more than 50 percent of the cost of contract performance to be incurred for personnel will be subcontracted to concerns that are not HUBZone small business concerns; or

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(4) Construction by special trade contractors.

(i) At least 25 percent of the cost of contract performance to be incurred for personnel will be spent on the prime contractor’s employees;

(ii) At least 50 percent of the cost of the contract performance to be incurred for personnel will be spent on the prime contractor’s employees or on a combination of the prime contractor’s employees and employees of HUBZone small business concern subcontractors;

(iii) No more than 50 percent of the cost of contract performance to be incurred for personnel will be subcontracted to concerns that are not HUBZone small business concerns.

(e) A HUBZone joint venture agrees that the aggregate of the HUBZone small business concerns to the joint venture, not each concern separately, will perform the applicable percentage of work requirements.

(f)

(1) When the total value of the contract exceeds $25,000, a HUBZone small business concern nonmanufacturer agrees to furnish in performing this contract only end items manufactured or produced by HUBZone small business concern manufacturers.

(2) When the total value of the contract is equal to or less than $25,000, a HUBZone small business concern nonmanufacturer may provide end items manufactured by other than a HUBZone small business concern manufacturer provided the end items are produced or manufactured in the United States.

(3) Paragraphs (f)(1) and (f)(2) of this section do not apply in connection with construction or service contracts.

(g) Notice. The HUBZone small business offeror acknowledges that a prospective HUBZone awardee must be a HUBZone small business concern at the time of award f this contract. The

HUBzone offeror shall provide the Contracting Officer a copy of the notice required by 13 CFR

126.501 if material changes occur before contract award that could affect its HUBZone eligibility. If the apparently successful HUBZone offeror is not a HUBzone small business concern at the time of award of this contract, the Contracting Officer will proceed to award to the next otherwise successful HUBZone small business concern or other offeror.

(End of clause)

15-100-SOL-00003

K.4. Trade Agreements Certificate

52.225-6 - TRADE AGREEMENTS CERTIFICATE (MAY 2014)

(a) The offeror certifies that each end product, except those listed in paragraph (b) of this provision, is a U.S.-made or designated country end product, as defined in the clause of this solicitation entitled “Trade Agreements.”

(b) The offeror shall list as other end products those supplies that are not U.S.-made or designated country end products.

Other End Products:

Line Item No. Country of Origin

[List as necessary]

(c) The Government will evaluate offers in accordance with the policies and procedures of

Part 25 of the Federal Acquisition Regulation. For line items covered by the WTO GPA, the

Government will evaluate offers of U.S.-made or designated country end products without regard to the restrictions of the Buy American statute. The Government will consider for award only offers of U.S.-made or designated country end products unless the Contracting Officer determines that there are no offers for such products or that the offers for those products are insufficient to fulfill the requirements of this solicitation.

(End of provision)

K.5. Online Representations and Certifications

1. Go to the System for Award Management at: www.sam.gov and complete the Representations and Certifications. Offerors shall indicate in their business proposal that the Online

Representations and Certifications have been completed.

2. To Be Completed by the Offeror: The following must be completed and included as part of your Business Proposal. By submission of its signed offer, the Offeror makes the following

Representations and Certifications

15-100-SOL-00003

Offer Submission Package http://acquisition.gov/far/current/html/FARTOCP25.html#wp225048 http://www.sam.gov/

52.204-8 -- Annual Representations and Certifications (Dec 2014)

(a)

(1) The North American Industry classification System (NAICS) code for this acquisition is 325414.

(2) The small business size standard is 500.

(3) The small business size standard for a concern which submits an offer in its own name, other than on a construction or service contract, but which proposes to furnish a product which it did not itself manufacture, is 500 employees.

(b)

(1) If the provision at 52.204-7, System for Award Management, is included in this solicitation, paragraph (d) of this provision applies.

(2) If the provision at 52.204-7 is not included in this solicitation, and the offeror is currently registered in the System for Award Management (SAM), and has completed the

Representations and Certifications section of SAM electronically, the offeror may choose to use paragraph (d) of this provision instead of completing the corresponding individual representations and certification in the solicitation. The offeror shall indicate which option applies by checking one of the following boxes:

[_] (i) Paragraph (d) applies.

[_] (ii) Paragraph (d) does not apply and the offeror has completed the individual representations and certifications in the solicitation.

(c)

(1) The following representations or certifications in SAM are applicable to this solicitation as indicated:

(i) 52.203-2, Certificate of Independent Price Determination. This provision applies to solicitations when a firm-fixed-price contract or fixed-price contract with economic price adjustment is contemplated, unless—

(A) The acquisition is to be made under the simplified acquisition procedures in Part 13;

(B) The solicitation is a request for technical proposals under two-step sealed bidding procedures; or

15-100-SOL-00003

(C) The solicitation is for utility services for which rates are set by law or regulation.

(ii) 52.203-11, Certification and Disclosure Regarding Payments to Influence

Certain Federal Transactions. This provision applies to solicitations expected to exceed $150,000.

(iii) 52.204-3, Taxpayer Identification. This provision applies to solicitations that do not include the provision at 52.204-7, System for Award Management.

(iv) 52.204-5, Women-Owned Business (Other Than Small Business). This provision applies to solicitations that—

(A) Are not set aside for small business concerns;

(B) Exceed the simplified acquisition threshold; and

(C) Are for contracts that will be performed in the United States or its outlying areas.

(v) 52.209-2, Prohibition on Contracting with Inverted Domestic Corporations—

Representation.

(vi) 52.209-5; Certification Regarding Responsibility Matters. This provision applies to solicitations where the contract value is expected to exceed the simplified acquisition threshold.

(vii) 52.214-14, Place of Performance--Sealed Bidding. This provision applies to invitations for bids except those in which the place of performance is specified by the Government.

(viii) 52.215-6, Place of Performance. This provision applies to solicitations unless the place of performance is specified by the Government.

(ix) 52.219-1, Small Business Program Representations (Basic & Alternate I).

This provision applies to solicitations when the contract will be performed in the

United States or its outlying areas.

(A) The basic provision applies when the solicitations are issued by other than DoD, NASA, and the Coast Guard.

(B) The provision with its Alternate I applies to solicitations issued by

DoD, NASA, or the Coast Guard.

15-100-SOL-00003

(x) 52.219-2, Equal Low Bids. This provision applies to solicitations when contracting by sealed bidding and the contract will be performed in the United

States or its outlying areas.

(xi) 52.222-22, Previous Contracts and Compliance Reports. This provision applies to solicitations that include the clause at 52.222-26, Equal Opportunity.

(xii) 52.222-25, Affirmative Action Compliance. This provision applies to solicitations, other than those for construction, when the solicitation includes the clause at 52.222-26, Equal Opportunity.

(xiii) 52.222-38, Compliance with Veterans' Employment Reporting

Requirements. This provision applies to solicitations when it is anticipated the contract award will exceed the simplified acquisition threshold and the contract is not for acquisition of commercial items.

(xiv) 52.223-1, Biobased Product Certification. This provision applies to solicitations that require the delivery or specify the use of USDA-designated items; or include the clause at 52.223-2, Affirmative Procurement of Biobased

Products Under Service and Construction Contracts.

(xv) 52.223-4, Recovered Material Certification. This provision applies to solicitations that are for, or specify the use of, EPA- designated items.

(xvi) 52.225-2, Buy American Certificate. This provision applies to solicitations containing the clause at 52.225-1.

(xvii) 52.225-4, Buy American--Free Trade Agreements--Israeli Trade Act

Certificate. (Basic, Alternates I, II, and III.) This provision applies to solicitations containing the clause at 52.225- 3.

(A) If the acquisition value is less than $25,000, the basic provision applies.

(B) If the acquisition value is $25,000 or more but is less than $50,000, the provision with its Alternate I applies.

(C) If the acquisition value is $50,000 or more but is less than $79,507, the provision with its Alternate II applies.

(D) If the acquisition value is $79,507 or more but is less than $100,000, the provision with its Alternate III applies.

(xviii) 52.225-6, Trade Agreements Certificate. This provision applies to solicitations containing the clause at 52.225-5.

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(xix) 52.225-20, Prohibition on Conducting Restricted Business Operations in

Sudan--Certification. This provision applies to all solicitations.

(xx) 52.225-25, Prohibition on Contracting with Entities Engaging in Certain

Activities or Transactions Relating to Iran—Representation and Certification.

This provision applies to all solicitations.

(xxi) 52.226-2, Historically Black College or University and Minority Institution

Representation. This provision applies to solicitations for research, studies, supplies, or services of the type normally acquired from higher educational institutions.

(2) The following certifications are applicable as indicated by the Contracting Officer:

__X_ (i) 52.204-17, Ownership or Control of Offeror.

___ (ii) 52.222-18, Certification Regarding Knowledge of Child Labor for Listed

End Products.

___ (iii) 52.222-48, Exemption from Application of the Service Contract Labor

Standards to Contracts for Maintenance, Calibration, or Repair of Certain

Equipment--Certification.

___ (iv) 52.222-52 Exemption from Application of the Service Contract Labor

Standards to Contracts for Certain Services--Certification.

___ (v) 52.223-9, with its Alternate I, Estimate of Percentage of Recovered

Material Content for EPA-Designated Products (Alternate I only).

___ (vi) 52.227-6, Royalty Information.

___ (A) Basic.

___ (B) Alternate I.

___ (vii) 52.227-15, Representation of Limited Rights Data and Restricted

Computer Software.

(d) The offeror has completed the annual representations and certifications electronically via the

SAM Web site accessed through https://www.acquisition.gov . After reviewing the SAM database information, the offeror verifies by submission of the offer that the representations and certifications currently posted electronically that apply to this solicitation as indicated in paragraph (c) of this provision have been entered or updated within the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard applicable to the NAICS code referenced for this solicitation), as of the date of this offer and are incorporated in this offer by reference (see FAR 4.1201); except for the changes

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https://www.acquisition.gov/ identified below [offeror to insert changes, identifying change by clause number, title, date].

These amended representation(s) and/or certification(s) are also incorporated in this offer and are current, accurate, and complete as of the date of this offer.

FAR Clause Title Date Change

Any changes provided by the offeror are applicable to this solicitation only, and do not result in an update to the representations and certifications posted on SAM.

(End of Provision)

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