Solicitation_AG-6395-S-15-0133.pdf

SEE ADDENDUMIS CHECKED

CODE 18a. PAYMENT WILL BE MADE BY

CODE

FACILITYCODE

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

OFFEROR

APHIS-MRPBS-ASD-6395

100 N 6TH STREET

Butler Square, 5th Floor ASD Procurement Branch

USDA APHIS MRPBS

APHIS-VS-WR-82YM CODE 16. ADMINISTERED BYCODE

X

X

325414

SIZE STANDARD:

% FOR:SET ASIDE:UNRESTRICTED ORAPHIS-MRPBS-ASD-6395

RFPIFB

10. THIS ACQUISITION ISCODE

RFQ

14. METHOD OF SOLICITATION

13b. RATING

NAICS:

SMALL BUSINESS

09/16/2015 1200 CT

08/17/2015

612-336-3223JAMES ROLOFF

(No collect calls)

INFORMATION CALL:

FOR SOLICITATION 8. OFFER DUE DATE/LOCAL TIMEb. TELEPHONE NUMBERa. NAME

4. ORDER NUMBER3. AWARD/ 6. SOLICITATION

AG-6395-S-15-0133

5. SOLICITATION NUMBER

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS 1. REQUISITION NUMBER PAGE OF

1 39 760481OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

MINNEAPOLIS MN 55403

TELEPHONE NO.

17a. CONTRACTOR/

Fort Collins CO 80526 Bldg B, #3E13 2150 Centre Avenue

APHIS-VS-WR-82YM

15. DELIVER TO

MINNEAPOLIS MN 55403

100 N 6TH STREET

Butler Square, 5th Floor ASD Procurement Branch

9. ISSUED BY

7.

2. CONTRACT NO.

EFFECTIVE DATE

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW

ISSUE DATE

DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

11.

SEE SCHEDULE

12. DISCOUNT TERMS

THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13a.

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

8(A)

USDA APHIS MRPBS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

Tax ID Number: Not Available DUNS Number: Not Available

Avian Influenza Vaccine, Eurasian H5 Subtype

See Price Schedule on page 3

(Use Reverse and/or Attach Additional Sheets as Necessary)

HEREIN, IS ACCEPTED AS TO ITEMS:

X

DATED

JAMES G. ROLOFF

. YOUR OFFER ON SOLICITATION (BLOCK 5),

INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DELIVER

ARE

ARE

31c. DATE SIGNED

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (Type or print)

ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL

SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED.

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

26. TOTAL AWARD AMOUNT (For Govt. Use Only)

OFFER

STANDARD FORM 1449 (REV. 2/2012)

Prescribed by GSA - FAR (48 CFR) 53.212

ARE NOT ATTACHED.

ARE NOT ATTACHED.

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

30b. NAME AND TITLE OF SIGNER (Type or print)

30a. SIGNATURE OF OFFEROR/CONTRACTOR

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN

25. ACCOUNTING AND APPROPRIATION DATA

29. AWARD OF CONTRACT:

REF.

32e. MAILING ADDRESS OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32c. DATE 32b. SIGNATURE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

ACCEPTED, AND CONFORMS TO THE CONTRACT, EXCEPT AS NOTED:

32a. QUANTITY IN COLUMN 21 HAS BEEN

RECEIVED INSPECTED

40. PAID BY39. S/R VOUCHER NUMBER38. S/R ACCOUNT NUMBER

37. CHECK NUMBER

FINALPARTIAL

36. PAYMENT

FINALPARTIAL

35. AMOUNT VERIFIED

CORRECT FOR

34. VOUCHER NUMBER33. SHIP NUMBER

COMPLETE

32g. E-MAIL OF AUTHORIZED GOVERNMENT REPRESENTATIVE

42d. TOTAL CONTAINERS42c. DATE REC'D (YY/MM/DD)

42b. RECEIVED AT (Location)

42a. RECEIVED BY (Print)

41c. DATE41b. SIGNATURE AND TITLE OF CERTIFYING OFFICER

41a. I CERTIFY THIS ACCOUNT IS CORRECT AND PROPER FOR PAYMENT

STANDARD FORM 1449 (REV. 2/2012) BACK

24.

AMOUNT

23.

UNIT PRICE

22.

UNIT

21.

QUANTITY

20.

SCHEDULE OF SUPPLIES/SERVICES

19.

ITEM NO.

32f. TELEPHONE NUMBER OF AUTHORIZED GOVERNMENT REPRESENTATIVE

32d. PRINTED NAME AND TITLE OF AUTHORIZED GOVERNMENT REPRESENTATIVE

39 2 of

Solicitation AG-6395-S-15-0133

1.0 PRICE SCHEDULE

The Government intends to award multiple commercial, firm-fixed price (FFP) indefinite-delivery indefinite-quantity (IDIQ) contract(s) for vaccines and vaccine combinations effective against Eurasian highly pathogenic avian influenza virus H5 clade 2.3.4.4 (EA H5) in order to establish an emergency vaccine stockpile. The vaccine stockpile will be used for emergency vaccination and to supplement commercial supplies as part of a larger vaccination campaign. A range of vaccine platforms will be considered, including inactivated vaccines, modified-live vaccines, nonviable/nonreplicating vaccines, gene-based vaccines, or any novel platform that meets the expectations for performance, amounts, and timing for delivery of these biologics detailed in the statement of work. Orders will be issued as necessary over the course of resultant contract(s) to meet surge requirements for off-the-shelf EA H5 vaccines. The estimated quantities listed for these items are the maximum quantities that could be ordered.

The minimum guaranteed order amount required by this contract is $6 million worth of doses. There is no guarantee that additional doses will be ordered throughout the remaining life of the contract.

Estimated Unit Unit Price Total Price Quantity

Year 1: 10/01/2015 – 09/30/2016

001. Manufacture/Store Precursor 500,000,000 Dose $____________ $____________

002. Finish/Deliver Vaccine 500,000,000 Dose $____________ $____________

Year 2: 10/01/2016 – 09/30/2017

003. Manufacture/Store Precursor 500,000,000 Dose $____________ $____________

004. Finish/Deliver Vaccine 500,000,000 Dose $____________ $____________

1.1 Notes

1.1.1 The result of this solicitation will be commercial, FFP, IDIQ contract(s).

1.1.2 Please ensure your firm provides all necessary items to be considered for award as outlined on page 21.

1.2 Questions

All questions must be submitted via email to: james.g.roloff@aphis.usda.gov.

mailto:james.g.roloff@aphis.usda.gov

1.3 Proposal due date, time, and format

In recognition of the fact that vaccine sufficient to meet the Government’s requirements may not currently exist, but may be developed over the course of a year by potential offerors, the Government will accept and evaluate proposals under the terms of this solicitation approximately every three months, through September 15, 2016, which evaluations may result in the award of additional IDIQ contracts. Offerors will be given notice in FedBizOpps (FBO) of each additional proposal submission deadline. Proposals submitted in response to subsequent FBO notices shall be subject to the same proposal instructions and evaluation procedures stated herein. Although the Government anticipates accepting proposals under at least one additional evaluation cycle, additional proposal submission opportunities are not guaranteed and will depend upon the Government’s requirements.

Proposals in response to this initial solicitation are due via email or mail no later than 12 p.m. CST on September 16, 2015. It is the offeror’s responsibility to ensure proposals are received on time.

If submitting via email please note that file size limitations, formatting, or other problems may hamper receipt so please verify that the contracting officer has received your proposal.

USDA APHIS MRPBS

Jim Roloff – Contracting 100 North 6th Street Suite 510C Butler Square Minneapolis, MN 55403 612-336-3223 James.g.roloff@aphis.usda.gov

1.4 Evaluation factors for award and submittals

As a result of this best-value, source-selection solicitation the Government will award one or more contracts to the responsible offeror or offerors, whose offer or combination of offers, conforming to the solicitation, will singularly or in combination be most advantageous to the Government, price and other factors considered. Please see the provision 52.212-2, Evaluation—Commercial Items, beginning on page 20, for the factors that will be used to evaluate your proposal for award consideration, followed by a list of the items required to be submitted to be eligible for award.

2.0 STATEMENT OF WORK FOR SUPPLYING EA H5 VACCINE

2.1 Purpose

To provide the National Veterinary Stockpile (NVS) with sufficient supplies of vaccine, to be used singly or in combination with other vaccines, that are effective against Eurasian HPAI H5 viruses of clade

2.3.4.4 lineage (referred to as EA H5 viruses), suitable for use in chickens and/or turkeys ranging from one-day of age up to ≥ 3 years of age. USDA/APHIS requires an emergency/supplementary stockpile of EA H5 vaccines available for delivery anywhere in the United States within 24 hours of order by the NVS.

mailto:James.g.roloff@aphis.usda.gov

2.2 Background

The arrival and subsequent dissemination of EA H5 viruses in North America caused a catastrophic epiornitic, affecting both domestic poultry and avian wildlife. It is thought that wild migratory waterfowl carried an EA H5 virus into North America, which generated reassortments that spilled over into the domestic poultry compartment. The EA H5 viruses are likely to persist within the endemic wild migratory waterfowl population which is the primary reservoir of the virus. This viral reservoir will continue to pose a significant threat to U.S. poultry and avian collections.

Two poultry production sectors, commercial meat turkeys and laying chickens, were heavily impacted by these EA H5 viruses, resulting in the loss or destruction of over 48 million birds between December 2014 and June 2015. Response by regulatory agencies combined with migration of wild waterfowl and the natural disinfectant action of the summer heat have temporarily halted any outbreaks. However, the return of potentially infected migratory waterfowl in autumn may precipitate a new round of outbreaks on an expanded, national scale.

The strategic use of avian influenza vaccines for protection of domestic poultry may be considered as an effective countermeasure to control any outbreaks. However, the amount of vaccine that may be required for such an effort largely depends on the poultry sector affected and the location of the outbreak. Nationally, the placement rate of laying hens and meat turkeys is approximately 20 million birds per month. With each bird requiring two doses of vaccine prior to placement, 80 million doses per month will be needed just for these two sectors alone. Currently, broilers appear to exhibit an increased resistance to infection for EA H5 viruses compared to other poultry use groups as no commercial broiler facilities have yet been reported to be infected. The reasons behind this resistance are not well understood, but should broilers become more susceptible to EA H5 viruses, then vaccination of a segment of this production sector may need to be considered. Nationally, the broiler egg set rate is an average of 220 million eggs per week.

NVS is the nation's repository of vaccines and other critical veterinary supplies and equipment. It exists to augment state and local resources in responding to high-consequence livestock diseases that could potentially devastate American agriculture, seriously affect the economy, and threaten public health.

H5 vaccines may only be used in the US when authorized firstly, by the Chief Veterinary Officer of the United States, and secondly, by each State Animal Health Official of the States where the vaccine is to be used. If used judiciously, AI vaccines can be an effective adjunct to AI eradication and control programs.

And, because of the ongoing threat from EA H5 viruses, the immediate availability of a range of EA H5 vaccine products would be beneficial to the U.S. poultry industry and captive avian wildlife collections.

The USDA/APHIS/VS/Center for Veterinary Biologics (CVB) is responsible for implementing the provisions of the Virus-Serum-Toxin Act regulating veterinary biologics for the diagnosis, prevention, and treatment of animal diseases. Any vaccines deemed eligible for use must meet all requirements for purity, safety, potency, and effectiveness as determined by the CVB.

Therefore in response to the threat posed by EA H5 viruses, the NVS seeks to stockpile individual vaccines or combinations of vaccines to protect poultry against clinical disease caused by EA H5 viruses after they have received a full course of vaccination.

2.3 Scope

The vaccine stockpile will be used for emergency vaccination and to also supplement commercial supplies as part of a larger vaccination campaign. A range of vaccine platforms will be considered including inactivated vaccines, modified-live vaccines, nonviable/nonreplicating vaccines, gene-based vaccines, or any novel platform that meets the expectations for performance, amounts, and timing for delivery of these biologics detailed in the statement of work.

• The period of performance will end two years from the date of contract award.

• Product shall be stored by the manufacturer in a manner that ensures the longest shelf-life while retaining satisfactory potency as determined by the CVB (e.g., vaccine antigen concentrate) which shall be no less than two (2) years;

• Small serials of finished vaccine shall be produced at the time of manufacture (first potency test), and 12 months after the first potency test by the manufacturer who will provide potency testing data commensurate with that product formulation to the CVB;

• Product fails that potency testing, or demonstrates a rate of decline in the level of potency suggesting that the product will fail before 24 months from the date of release, must be replaced at manufacturer’s expense;

• Manufacturers shall complete production of the vaccine precursor (e.g., vaccine antigen concentrate) within 45 days;

• Manufacturers will have 10 days to complete finishing of the vaccine upon issuance of a delivery order and 3 days to deliver the finished vaccine to a location to be designated by Veterinary Services within the U.S.

2.4 Vaccine efficacy requirements

• Efficacy shall be demonstrated by providing data that the vaccine or vaccine combination can protect at least 90% of fully vaccinated chickens and turkeys against clinical disease if challenged with EA H5 viruses no less than two weeks after the final vaccine is administered;

or there is a reasonable expectation of such efficacy as determined by a CVB vaccine review panel based on the history of performance of the vaccine platform(s) being considered;

• Manufacturers shall verify that the product is licensed (fully or conditionally) or permitted by CVB when the NVS issues a delivery order against the contract;

• Vaccines shall be labeled for use in at least one or more of the target species (i.e. chickens, turkeys) but preferably both;

The goal is to develop vaccines that are:

• Functional in one day old chicks and/or turkey poults in the presence of serologically quantifiable maternal antibody against EA H5 viruses;

• Compatible with DIVA (differentiating infected from vaccinated animal) testing. Serological

DIVA testing is often the most frequently employed; but depending on the vaccination strategy and the vaccine or vaccine combinations used, serological DIVA testing such as ELISA may not be possible. Therefore, DIVA testing may also include molecular surveillance such as PCR, or other diagnostic methods such as VI;

• Capable of preventing or significantly reducing virus shedding (e.g., ≥ 3 log10 reduction);

• Capable of providing duration of protective immunity ≥ 90% against clinical disease in the target species ≥ 6 months will be given preference.

2.5 Vaccine potency requirements

• Minimum acceptable potency determination will be made in coordination with the CVB prior to delivery order award;

• The finished vaccine must exhibit a minimum shelf-life for potency of at least one year and vaccine precursor must exhibit a minimum shelf-life of at least two years;

• The finished vaccine or vaccine precursor shall be maintained by the manufacturer in a formulation or state that provides the longest shelf-life for that product while retaining full potency.

• Whether maintained as a finished vaccine or vaccine precursor, the manufacturer is responsible for appropriate storage, quality control, and testing to ensure consistent and full potency.

2.6 Technical requirements, preferences, and structure of purchase

• Vaccine or vaccine precursors must be produced 45 days after award and maintained by the contractor, which is responsible for its storage and maintenance;

• This vaccine will be held and made available to NVS at the manufacturer for a period of two years from the date of date of release based on the first successful potency test to serve as a supplementary supply or emergency vaccine stock used in response to outbreaks;

• Small serials of finished vaccine will be produced at the time of manufacture (first potency test), and 12 months after the first potency test by the manufacturer who will provide potency testing data commensurate with that product formulation to the CVB;

• If diluent is required, the contractor will also supply diluent sufficient to rehydrate the ordered number of vaccine doses;

• If cryogenic preservation is required when shipping, then one data logger and one temperature strip (chemical) will be required to accompany the shipment of finished vaccine.

Shipping methods used to transport the vaccine should be capable of maintaining the appropriate preservation temperature for at least 72 hours.

• Vaccines that possess the flexibility of administration in a range of ages in chicks and/or turkey poults from one day of age to adult birds ≥3 years of age may be given preference.

• Vaccines that demonstrate the longest duration of immunity, alone or in combination, may be given preference.

• All deliverables, including vial size, shipping locations, timing of delivery, and other logistics matters will be negotiated for each delivery order.

3.0 CONTRACT ADMINISTRATION

3.1 Delivery orders

Delivery orders may be placed by a warranted contracting officer via mail, orally, or through email. They will be issued against this contract on a firm-fixed-price basis at the agreed price.

3.2 Fair Opportunity

In the event of multiple contract awards, each contractor will be given a fair opportunity to compete for awards in accordance with the provisions of FAR 16.605(b) per the applicable purchase amount threshold. Significant factors or subfactors for delivery order award, including cost or price, will be specified at the time offerors are provided a fair opportunity to compete for each award. The Government will award one or more delivery orders to the responsible contractor or contractors whose offer or offers, conforming to the requirements in Section 2.0 Statement of Work, will singlularly or in combination be most advantageous to the Government, price and other factors considered.

3.3 Invoicing information

USDA uses the Invoice Processing Platform (IPP) for electronic submission and tracking of purchase orders, invoices, and payment information to its suppliers of goods and services. Enroll at https://ipp.gov. IPP is a government-wide, secure, web-based invoice processing service offered free of charge to government agencies and their suppliers by the U.S. Department of Treasury’s Financial Management Service.

Upon contract award, you will receive a notification of your one-time enrollment requirement in an automatic invoice payment notification system available through IPP. This one-time enrollment in IPP means that you will receive a series of e-mails from Treasury services.

3.4 Points of contact

For questions regarding general contract administration, please contact Jim Roloff, contracting officer, at 612-336-3223, james.g.roloff@aphis.usda.gov.

Technical point of contact information will be provided at the time of award.

3.5 COR and technical points of contact

The contracting officer has designated a contracting officer’s representative (COR) who will be identified at the time of contract award.

The COR is responsible for monitoring the performance of work under this contract and is the local Government contact. In no event, however, will any understanding, agreement, modification, change order, or other matter deviating from the terms of the contract be effective or binding upon the Government unless advance authorization is received from the contracting officer, and proper contractual documents executed by the contracting officer prior to performing the work.

The COR shall inform the contracting officer as soon as possible of any understandings, tentative agreements, recommended modifications, and actions or inactions of the contractor or the Government which could impact the contractor’s ability to comply with the contract performance requirements or completion times.

https://ipp.gov/ mailto:james.g.roloff@aphis.usda.gov

Whenever, in the opinion of the contractor, the COR requests effort outside the scope of the contract, the contractor shall so advise the COR. If the COR persists and there still exists a disagreement as to proper contractual coverage, the contracting officer shall be notified immediately.

PROCEEDING WITH WORK WITHOUT PROPER CONTRACTUAL COVERAGE AND APPROVAL OF THE CO

COULD RESULT IN A BREACH OF CONTRACT AND NONPAYMENT.

This delegation of authority is provided in writing to the COR and is available to the contractor. The delegation of authority clearly explains the CORs roles and responsibilities on the contract and limitations of authority.

3.6 Placement of orders

The contractor shall provide the products under this contract only as directed in the delivery orders. In accordance with FAR 16.505, each order will include:

(i) Date of order

(ii) Contract number and order number

(iii) Item number and description, quantity, and unit price

(iv) Delivery date

(v) Place of delivery or performance (including consignee)

(vi) Packaging, packing, and shipping instructions, if any

(vii) Accounting and appropriation data

(viii) Method of payment and payment office, if not specified in the contract

(ix) Any other pertinent information

4.0 CONTRACT CLAUSES

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 address:

http://farsite.hill.af.mil/farsite_alt.html

52.203-12 Limitation on Payments to Influence Certain Federal Transactions (Oct 2010) 52.212-4 Contract Terms and Conditions—Commercial Items (May 2015) 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013) http://farsite.hill.af.mil/farsite_alt.html

Clauses in full text

52.212-5 -- Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items. (May 2015)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (DEC 2014)

(2) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(3) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108- 77 and 108-78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(Contracting Officer check as appropriate.)

[X] (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (SEP 2006), with Alternate I (OCT 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

[X] (2) 52.203-13, Contractor Code of Business Ethics and Conduct (APR 2010) (41 U.S.C.

3509).

[ ] (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (JUN 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.)

[X] (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (JUL 2013) (Pub. L. 109-282) (31 U.S.C. 6101 note).

(5) (Reserved)

[ ] (6) 52.204-14, Service Contract Reporting Requirements (JAN 2014) (Pub. L. 111-117, section 743 of Div. C).

[ ] (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (JAN 2014) (Pub. L. 111-117, section 743 of Div. C).

[X] (8) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (AUG 2013) (31 U.S.C.

6101 note).

[ ] (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (JUL 2013) (41 U.S.C. 2313).

[ ] (10) (Reserved)

[ ] (11)(i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (NOV 2011) (15 U.S.C. 657a).

[ ] (ii) Alternate I (NOV 2011) of 52.219-3.

[ ] (12)(i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

[ ] (ii) Alternate I (JAN 2011) of 52.219-4.

[ ] (13) (Reserved)

[ ] (14)(i) 52.219-6, Notice of Total Small Business Set-Aside (NOV 2011) (15 U.S.C. 644).

[ ] (ii) Alternate I (NOV 2011).

[ ] (iii) Alternate II (NOV 2011).

[ ] (15)(i) 52.219-7, Notice of Partial Small Business Set-Aside (JUN 2003) (15 U.S.C. 644).

[ ] (ii) Alternate I (OCT 1995) of 52.219-7.

[ ] (iii) Alternate II (MAR 2004) of 52.219-7.

[X] (16) 52.219-8, Utilization of Small Business Concerns (OCT 2014) (15 U.S.C. 637(d)(2) and (3)).

[ ] (17)(i) 52.219-9, Small Business Subcontracting Plan (OCT 2014) (15 U.S.C. 637(d)(4)).

[ ] (ii) Alternate I (OCT 2001) of 52.219-9.

[X] (iii) Alternate II (OCT 2001) of 52.219-9.

[ ] (18) 52.219-13, Notice of Set-Aside of Orders (NOV 2011) (15 U.S.C. 644(r)).

[ ] (19) 52.219-14, Limitations on Subcontracting (NOV 2011) (15 U.S.C. 637(a)(14)).

[X] (20) 52.219-16, Liquidated Damages-Subcontracting Plan (JAN 1999) (15 U.S.C.

637(d)(4)(F)(i)).

[ ] (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (NOV 2011) (15 U.S.C. 657f).

[ ] (22) 52.219-28, Post Award Small Business Program Rerepresentation (JUL 2013) (15 U.S.C. 632(a)(2)).

[ ] (23) 52.219-29, Notice of Set-Aside for Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (JUL 2013) (15 U.S.C. 637(m)).

[ ] (24) 52.219-30, Notice of Set-Aside for Women-Owned Small Business (WOSB) Concerns Eligible Under the WOSB Program (JUL 2013) (15 U.S.C. 637(m)).

[X] (25) 52.222-3, Convict Labor (JUN 2003) (E.O. 11755).

[X] (26) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (JAN 2014) (E.O. 13126).

[X] (27) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

[X] (28) 52.222-26, Equal Opportunity (APR 2015) (E.O. 11246).

[X] (29) 52.222-35, Equal Opportunity for Veterans (JUL 2014) (38 U.S.C. 4212).

[X] (30) 52.222-36, Equal Opportunity for Workers with Disabilities (JUL 2014) (29 U.S.C.

793).

[X] (31) 52.222-37, Employment Reports on Veterans (JUL 2014) (38 U.S.C. 4212).

[X] (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496).

[X] (33)(i) 52.222-50, Combating Trafficking in Persons (MAR 2015) (22 U.S.C. chapter 78 and E.O. 13627).

[ ] (ii) Alternate I (MAR 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O.

13627).

[X] (34) 52.222-54, Employment Eligibility Verification (AUG 2013). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

[ ] (35)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA- Designated Items (MAY 2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

[ ] (ii) Alternate I (MAY 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

[ ] (36)(i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (JUN 2014) (E.O.s 13423 and 13514).

[ ] (ii) Alternate I (JUN 2014) of 52.223-13.

[ ] (37)(i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (JUN 2014) (E.O.s 13423 and 13514).

(ii) Alternate I (JUN 2014) of 52.223-14.

[ ] (38) 52.223-15, Energy Efficiency in Energy-Consuming Products (DEC 2007) (42 U.S.C.

8259b).

[ ] (39)(i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (JUN 2014) (E.O.s 13423 and 13514).

[ ](ii) Alternate I (JUN 2014) of 52.223-16.

[X] (40) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving

(AUG 2011)

[ ] (41) 52.225-1, Buy American-Supplies (MAY 2014) (41 U.S.C. chapter 83).

[ ] (42)(i) 52.225-3, Buy American-Free Trade Agreements-Israeli Trade Act (MAY 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.

[ ] (ii) Alternate I (MAY 2014) of 52.225-3.

[ ] (iii) Alternate II (MAY 2014) of 52.225-3.

[ ] (iv) Alternate III (MAY 2014) of 52.225-3.

[X] (43) 52.225-5, Trade Agreements (NOV 2013) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

[X] (44) 52.225-13, Restrictions on Certain Foreign Purchases (JUN 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

[ ] (45) 52.225-26, Contractors Performing Private Security Functions Outside the United States (JUL 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

[ ] (46) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (NOV 2007) (42 U.S.C.

5150).

[ ] (47) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area

(NOV 2007) (42 U.S.C. 5150).

[ ] (48) 52.232-29, Terms for Financing of Purchases of Commercial Items (FEB 2002) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

[ ] (49) 52.232-30, Installment Payments for Commercial Items (OCT 1995) (41 U.S.C.

4505, 10 U.S.C. 2307(f)).

[X] (50) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (JUL 2013) (31 U.S.C. 3332).

[ ] (51) 52.232-34, Payment by Electronic Funds Transfer - Other than System for Award Management (JUL 2013) (31 U.S.C. 3332).

[ ] (52) 52.232-36, Payment by Third Party (MAY 2014) (31 U.S.C. 3332).

[ ] (53) 52.239-1, Privacy or Security Safeguards (AUG 1996) (5 U.S.C. 552a).

[ ] (54)(i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (FEB 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631).

[ ] (ii) Alternate I (APR 2003) of 52.247-64.

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items: (Contracting Officer check as appropriate.)

[ ] (1) 52.222-17, Nondisplacement of Qualified Workers (MAY 2014) (E.O. 13495).

[ ] (2) 52.222-41, Service Contract Labor Standards (MAY 2014) (41 U.S.C. chapter 67).

[ ] (3) 52.222-42, Statement of Equivalent Rates for Federal Hires (MAY 2014) (29 U.S.C.

206 and 41 U.S.C. chapter 67).

[ ] (4) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple Year and Option Contracts) (MAY 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

[ ] (5) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (MAY 2014) (29 U.S.C 206 and 41 U.S.C. chapter 67).

[ ] (6) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (MAY 2014) (41 U.S.C. chapter 67).

[ ] (7) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements (MAY 2014) (41 U.S.C. chapter 67).

[X] (8) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2014) (E.O.

13658).

[ ] (9) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (MAY 2014) (42 U.S.C. 1792).

[ ] (10) 52.237-11, Accepting and Dispensing of $1 Coin (SEP 2008) (31 U.S.C. 5112(p)(1)).

(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records

- Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor's directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) of this paragraph in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause-

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (APR 2010) (41 U.S.C. 3509).

(ii) 52.219-8, Utilization of Small Business Concerns (OCT 2014) (15 U.S.C.

637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $650,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(iii) 52.222-17, Nondisplacement of Qualified Workers (MAY 2014) (E.O. 13495).

Flow down required in accordance with paragraph (l) of FAR clause 52.222-17.

(iv) 52.222-21, Prohibition of Segregated Facilities (APR 2015).

(v) 52.222-26, Equal Opportunity (APR 2015) (E.O. 11246).

(vi) 52.222-35, Equal Opportunity for Veterans (JUL 2014) (38 U.S.C. 4212).

(vii) 52.222-36, Equal Opportunity for Workers with Disabilities (JUL 2014) (29 U.S.C. 793).

(viii) 52.222-37, Employment Reports on Veterans (JUL 2014) (38 U.S.C. 4212).

(ix) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

(x) 52.222-41, Service Contract Labor Standards (MAY 2014) (41 U.S.C. chapter 67).

(xi) __ (A) 52.222-50, Combating Trafficking in Persons (MAR 2015) (22 U.S.C.

chapter 78 and E.O. 13627).

__ (B) Alternate I (MAR 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

__Alternate I (AUG 2007) of 52.222-50 (22 U.S.C. 7104(g)).

(xii) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (MAY 2014) (41 U.S.C. chapter 67).

(xiii) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements (MAY 2014) (41 U.S.C.

chapter 67).

(xiv) 52.222-54, Employment Eligibility Verification (AUG 2013).

(xv) 52.222-55, Minimum Wages Under Executive Order 13658 (DEC 2014) (E.O.

13658).

(xvi) 52.225-26, Contractors Performing Private Security Functions Outside the United States (JUL 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

(xvii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (MAY 2014) (42 U.S.C. 1792). Flow down required in accordance with paragraph

(e) of FAR clause 52.226-6.

(xviii) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (FEB 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

(2) While not required, the contractor May include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.

(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 at any time during the performance period.

(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 (i.e., email) 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 50,000,000 doses, 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 in excess of 500,000,000 doses; or

(2) Any order for a combination of items in excess of 500,000,000 doses; or

(3) A series of orders from the same ordering office within 30 days that together call for quantities exceeding the limitation in subparagraph (b)(1) or (2) of this section.

(c) Notwithstanding the order maximum of 500,000,000 doses (paragraph (b)(2) of this section, the Contractor shall honor any order exceeding the maximum order limitations in paragraph (b)(1), unless that order (or orders) is returned to the ordering office within 10 business days after issuance, with written notice stating the Contractor’s inability to perform and the reasons. Upon receiving this notice, the Government may acquire the supplies or services from other sources.

52.216-22 -- Indefinite Quantity. (Oct 1995)

(a) This is an indefinite-quantity contract for the supplies or services specified, and effective for the period stated, in the Schedule. The quantities of supplies and services specified in the Schedule are estimates only and are not purchased by this contract.

(b) Delivery or performance 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 or services 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 two years from the date the contract is awarded.

452.216-73 Minimum and Maximum Contract Amounts. (FEB 1988)

During the period specified in FAR clause 52.216-18, Ordering, the Government shall place orders totaling a minimum of $6,000,000, but not in excess of 500,000,000 doses.

5.0 CONTRACT PROVISIONS

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 offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es): http://farsite.hill.af.mil/farsite_alt.html

52.203-11 Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions (Sep 2007) 52.212-1 Instructions to Offerors—Commercial Items (Apr 2014) 52.216-27 Single or Multiple Awards (Oct 1995)

Provisions in full text

52.209-7 Information Regarding Responsibility Matters (Jul 2013)

(a) Definitions. As used in this provision—

“Administrative proceeding” means a non-judicial process that is adjudicatory in nature in order to make a determination of fault or liability (e.g., Securities and Exchange Commission Administrative Proceedings, Civilian Board of Contract Appeals Proceedings, and Armed Services Board of Contract Appeals Proceedings). This includes administrative proceeding at the Federal and State level but only in connection with performance of a Federal contract or grant. It does not include agency actions such as contract audits, site visits, corrective plans, or inspection of deliverables.

“Federal contracts and grants with total value greater than $10,000,000” means—

(1) The total value of all current, active contracts and grants, including all priced options; and

(2) The total value of all current, active orders including all priced options under indefinite-delivery, indefinite-quantity, 8(a), or requirements contracts (including task and delivery and multiple-award Schedules).

“Principal” means an officer, director, owner, partner, or a person having primary management or supervisory responsibilities within a business entity (e.g., general manager; plant manager; head of a division or business segment; and similar positions).

(b) The offeror [_] has [_] does not have current active Federal contracts and grants with total value greater than $10,000,000.

(c) If the offeror checked “has” in paragraph (b) of this provision, the offeror represents, by submission of this offer, that the information it has entered in the Federal Awardee Performance and Integrity http://farsite.hill.af.mil/farsite_alt.html

Information System (FAPIIS) is current, accurate, and complete as of the date of submission of this offer with regard to the following information:

(1) Whether the offeror, and/or any of its principals, has or has not, within the last five years, in connection with the award to or performance by the offeror of a Federal contract or grant, been the subject of a proceeding, at the Federal or State level that resulted in any of the following dispositions:

(i) In a criminal proceeding, a conviction.

(ii) In a civil proceeding, a finding of fault and liability that results in the payment of a monetary fine, penalty, reimbursement, restitution, or damages of $5,000 or more.

(iii) In an administrative proceeding, a finding of fault and liability that results in—

(A) The payment of a monetary fine or penalty of $5,000 or more; or

(B) The payment of a reimbursement, restitution, or damages in excess of $100,000.

(iv) In a criminal, civil, or administrative proceeding, a disposition of the matter by consent or compromise with an acknowledgment of fault by the Contractor if the proceeding could have led to any of the outcomes specified in paragraphs (c)(1)(i), (c)(1)(ii), or (c)(1)(iii) of this provision.

(2) If the offeror has been involved in the last five years in any of the occurrences listed in (c)(1) of this provision, whether the offeror has provided the requested information with regard to each occurrence.

(d) The offeror shall post the information in paragraphs (c)(1)(i) through (c)(1)(iv) of this provision in FAPIIS as required through maintaining an active registration in the System for Award Management database via https://www.acquisition.gov (see 52.204-7).

(End of provision)

52.212-2 Evaluation—Commercial Items (Oct 2014)

(a) The Government will award one or more contracts resulting from this best-value, source-selection solicitation to the responsible offeror or offerors, whose offer or combination of offers, conforming to the solicitation, will singularly or in combination be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

Price

Please complete the price schedule in Section 1.0.

Technical Capability https://www.acquisition.gov/

• Production and finishing capacity that could supply multiple States (i.e., at least three affected poultry-dense States with up to 100 million doses per month) engaged in a vaccination campaign.

• Demonstrated ability to maintain product on the offeror’s premises (either finished vaccine or vaccine precursor) in the appropriate manner (e.g., cryo-storage);

• Capability of monitoring and performing potency evaluations as stipulated by CVB for that product to ensure its viability;

• A detailed quality assurance plan describing a quality control system that ensures product stability and clearly demonstrates ability to meet contract requirements.

Past Performance

Past performance is a measure of the degree to which an offeror has satisfied customers in the past, and complied with federal, state, and local laws and regulations. The assessment of past performance will be subjective, and based mainly on offeror reputations with customers and others. The Government may evaluate the performance data provided by offerors or obtained from other sources.

Past performance assessments may be based on information such as the contracting officer and evaluator’s knowledge of previous experience with the supply or service being acquired, customer surveys, or other reasonable basis. The assessment will consider the contractor’s record of conforming to specifications and to standards of good workmanship/customer service. In addition, adherence to contract schedules, including the administrative aspects of performance, will be taken into consideration.

Offers lacking past performance will receive a neutral rating.

Past performance checks will only be conducted on the highest rated proposals.

Technical capability and past performance, when combined, are significantly more important that price.

(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.

NOTE:

The following items are required to be submitted to be eligible for award

1) A signed copy of the SF 1449. Please complete Block 17a, including Federal Tax ID number, and DUNS number.

2) Price schedule for each year of the contract as organized in Section 1.0 of the solicitation.

3) Technical proposal including complete documentation of evaluation items described in this provision (above), including efficacy data as specified in the statement of work, Section 2.4.

4) Proof of license/permit or plan of application.

5) Quality assurance plan.

6) Small business subcontracting plan (if large business)

Large businesses only are required to submit a small business subcontracting plan in accordance with FAR 52.219-9 Alternate II (Oct 2001) with their quotes. The following are the USDA subcontracting goals.

- Overall small business 22%

- Small, disadvantaged business 5%

- Woman-owned small business 5%

- HUBZone small business 3%

- Service-disabled, veteran-owned small business 3%

7) Past Performance: Three references detailing similar products provided to other customers in the past five years. Include:

a. Company or agency name

b. Size/frequency of order

c. Point of contact

i. Name

ii. Phone Number

iii. Email Address

8) System for Award Management (SAM) registration: SAM registration is required of all federal contractors. SAM registration enables electronic funds transfer of contract payments. If your company is not already registered, please register in the SAM database at www.sam.gov.

a. A DUNS number is required for SAM registration. If your company does not have

DUNS #, obtain one by calling 800-333-0505.

b. If the prospective awardee for this RFP is not…