sol_CSF_vaccine_DIVA_2014_amended.pdf

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24 & 30

1. REQUISITION NUMBER PAGE 1 OF 25

700417

2. CONTRACT NUMBER 3. AWARD/EFFECTIVE DATE 4. ORDER NUMBER 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

See Block 31C AG-6395-S-14-0137 08/12/2014; Rev 8/27/2014

7. FOR SOLICITATION

INFORMATION

CONTACT:

a. NAME

Larry Nelson, Contracting Officer Larry.d.nelson@aphis.usda.gov

b. TELEPHONE NUMBER (no collect calls)

(612) 336-3225

8. OFFER DUE DATE/

LOCAL TIME

09/09/2014

10:00 AM CT

9. ISSUED BY CODE 6395 10. THIS ACQUISITION IS

USDA, APHIS, MRPBS, ASD, Contracting Team Butler Square, 5th Floor 100 North Sixth Street Minneapolis, MN 55403

UNRESTRICTED OR SET-ASIDE FOR:

SMALL BUSINESS EMERGING SMALL

BUSINESS

HUBZONE SMALL 8(A)

BUSINESS

SERVICE-DISABLED VETERAN-

OWNED SMALL BUSINESS

NAICS: 325414

SIZE

STANDARD:

11. DELIVERY FOR FOB DESTINATION

UNLESS BLOCK IS MARKED

See Schedule

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

See Schedule

See Block 9

17a. CONTRACTOR/OFFEROR CODE FACILITY 18a. PAYMENT WILL BE MADE BY CODE

Invoice Processing Platform System www.ipp.gov

TELEPHONE NO.

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

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

SEE ADDENDUM

19.

ITEM NO.

20.

SCHEDULE OF SUPPLIES/SERVICES

21.

QUANTITY

22.

UNIT

23.

UNIT PRICE

24.

AMOUNT

SEE ATTACHED

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

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

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

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

ADDENDA ARE ARE NOT ATTACHED.

ADDENDA ARE ARE NOT ATTACHED.

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN __1__ COPY TO

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

OR OTHERWISE IDENTIFIED ABOVE AND ON ANY ADDITIONAL SHEETS SUBJECT TO THE

TERMS AND CONDITIONS SPECIFIED.

29. AWARD OF CONTRACT: REF. OFFER DATED. YOUR OFFER ON SOLICITATION

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE SET FORTH HEREIN, IS

ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (Type or Print) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (Type or Print) 31c. DATE SIGNED

Larry D. Nelson

AUTHORIZED FOR LOCAL REPRODUCTION

PREVIOUS EDITION IS NOT USABLE

STANDARD FORM 1449 (REV. 3/2005)

Prescribed by GSA - FAR (48 CFR) 53.212

Solicitation AG-6395-S-14-0137---Classical Swine Fever (CSF) Vaccine Page 1 of 25 http://www.ipp.gov/

II. SF 41449 Continuation:

A. Schedule of Items:

This will be an Indefinite Delivery Indefinite Quantity (IDIQ) contract. Delivery Orders will be issued as necessary during the period of performance of this contract. The government intends to award an initial order for 1 million doses of the vaccine at or about the time of the initial contract award (CLIN 01 below). This will satisfy the minimum guaranteed amount of this contract and future orders will be dependent on any animal emergencies and/or other events which cannot be predicted at this time. Thus, quantities for CLINS 002 through 403 below are only estimates and may vary greatly. All pricing should be EXCLUSIVE of transportation costs as the exact delivery locations are unknown at this time. Any necessary transportation costs will be added to the contract/order as a cost-reimbursement item at the time quantities are ordered and/or delivered.

Base Period: Date of Award through August 31, 2015:

ITEM N0. QUANTITY UNIT UNIT TOTAL

PRICE PRICE

001. Classical Swine Fever Virus Vaccine, DIVA 1,000,000 Doses ________ ________ Firm-fixed price amount for 1 million doses

002. Classical Swine Fever Virus Vaccine, DIVA 200,000 Doses ________ _________ (Estimated Quantity only)

003. Classical Swine Fever Virus antigen concentrate (VAC) 200,000 Doses ________ _________ (Optional Line Item: Estimated Quantity only)

Option Period One: September 1, 2015 through August 31, 2016

102. Classical Swine Fever Virus Vaccine, DIVA 200,000 Doses ________ _________ (Estimated Quantity only)

103. Classical Swine Fever Virus antigen concentrate (VAC) 200,000 Doses ________ _________ (Optional Line Item: Estimated Quantity only)

Option Period Two: September 1, 2016 through August 31, 2017

202. Classical Swine Fever Virus Vaccine, DIVA 200,000 Doses ________ _________ (Estimated Quantity only)

203. Classical Swine Fever Virus antigen concentrate (VAC) 200,000 Doses ________ _________ (Optional Line Item: Estimated Quantity only)

Option Period Three: September 1, 2017 through August 31, 2018

302. Classical Swine Fever Virus Vaccine, DIVA 200,000 Doses ________ _________ (Estimated Quantity only)

303. Classical Swine Fever Virus antigen concentrate (VAC) 200,000 Doses ________ _________ (Optional Line Item: Estimated Quantity only)

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Option Period Four: September 1, 2018 through August 31, 2019

402. Classical Swine Fever Virus Vaccine, DIVA 200,000 Doses ________ _________ (Estimated Quantity only)

403. Classical Swine Fever Virus antigen concentrate (VAC) 200,000 Doses ________ _________ (Optional Line Item: Estimated Quantity only)

III. – DESCRIPTION/SPECIFICATIONS/WORK STATEMENT:

1.0 STATEMENT OF WORK FOR CLASSICAL SWINE FEVER VIRUS VACCINE SUPPLY

1.1 Background

The National Veterinary Stockpile (NVS) is the nation's repository of vaccines and other critical veterinary supplies and equipment. It exists to augment state and local resources in the fight against dangerous animal diseases that could potentially devastate American agriculture, seriously affect the economy, and threaten the public’s health.

Homeland Security Presidential Directive 9 established the NVS in 2004. It required the NVS to deploy within 24 hours “sufficient amounts of animal vaccine, antiviral, or therapeutic products to appropriately respond to the most damaging animal diseases affecting human health and the economy…” The directive reflects the nation’s concern that terrorists could simultaneously, in multiple locations, release disease threats of an unprecedented magnitude; thus, the need for an NVS that could deliver at the least cost, large quantities of critical veterinary supplies and equipment to the right place at the right time for as long as is necessary.

The NVS stores its inventory in multiple locations and in sufficient volume to ensure its ability to respond to multiple, large-scale, simultaneous animal disease outbreaks.

The NVS obtains guidance and direction in defining “dangerous animal diseases” from the NVS’ Steering Committee.

The Steering Committee also directs the formation of expert working groups, on a disease-by-disease basis, to develop short- and long-term recommendations for vaccines, diagnostics, and other critical veterinary supplies and equipment suitable for incorporation into the NVS.

The Classical Swine Fever (CSF) Countermeasures Working Group (CSFCWG) was charged by the NVS Steering Committee with making recommendations on specific materials, commercially available and in the pipeline, which will ensure that the United States has an arsenal of highly efficacious countermeasures to control and mitigate the impact of an outbreak of CSF. The CSFCWG recommended stockpiling CSFV vaccine with the following efficacy profile: highly efficacious including maternal antibody override, efficacy in all age pigs, one dose, prevents virus transmission, onset of immunity ≤7 days, ≥24 months expiration dating, DIVA compatible; and safety profile: no reversion to virulence, safe in all age pigs, and short withdrawal period for food consumption.

1.2 Scope

The Government wishes to acquire limited supplies of vaccine that the manufacturer will quarantine and store on licensed premises prior to disease outbreaks and to establish a reliable source of additional vaccine that it can purchase during outbreaks if government inventories are insufficient. The Contractor will ship the vaccine to locations specified by the government. In addition, the Contractor will support the government’s need for additional supplies of vaccine during prolonged responses to disease outbreaks. Additional vaccine supplies may be prepared from VAC or from existing inventories of ready-to-use vaccine.

The NVS seeks a contract to obtain and have contractor maintain on hand up to 1,000,000 doses of finished, ready-to-use Classical Swine Fever Virus Vaccine. The Contractor and the NVS must develop suitable mechanisms to rotate finished vaccine to ensure product held by the NVS remains within satisfactory product dating for use throughout the term of the contract (5 years). Finished vaccine must be suitable for distribution and sale in the United States, as regulated by the USDA Center for Veterinary Biologics (CVB); however, the USDA will accept bids from manufacturers that agree to submit an application for a License or Permit, and provide a plan for product licensing with their bid, that shows commitment to obtain a License or Permit within a reasonable time frame.

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If a CSF outbreak occurs, VS seeks to obtain up to an additional 20 million doses of finished CSFV vaccine at a rate of 1 million doses/week, starting about 3 weeks from the date the order is placed. If finished vaccine is prepared from bulk antigens the bid should describe the plan to monitor bulk antigen stability, and the manufacturer’s commitment to replenish, at the manufacturer’s expense, bulk antigens that lose potency in order that the agreed upon number of doses (e.g., 20 million doses) of finished product can be delivered by the agreed upon times.

1.3 Period of performance

The intent is to issue an Indefinite Delivery Indefinite Quantity (IDIQ) contract starting on approximately September 15, 2014. The need for surge amounts is unknown at this time. Delivery Orders will be issued as necessary.

1.4 Deliverables

A. The contract shall have two or three components:

1. The production, storage and delivery of 1,000,000 doses of CSFV Vaccine. One hundred thousand doses should be filled in 50 dose vials and 900,000 doses should be filled in 250 dose vials. The product shall be ready for distribution within 24 hours activation of the CSF Vaccine stockpile. The shelf-life for these doses must be at least 24 months. Upon expiration of the labeled product date, potency testing must be performed for possible extended use. If expiry potency is exceeded, the Contractor shall submit a request to extend dating to USDA-CVB; if CVB grants request then costs to meet extended dating requirements (e.g., additional stability data) are assumed by the Contractor. This vaccine must be suitable and eligible for distribution in the United States, as demonstrated by a United States Veterinary Biologics Product License or Permit for Distribution and Sale, as issued by the United States Department of Agriculture, Center for Veterinary Biologics, or as demonstrated by an application and commitment (plan for product licensing) to obtain a License or Permit; AND

2. In addition, the Contractor should provide for the production and delivery of at least 1 million additional doses of vaccine per week, for up to 20 weeks through: The production of Classical Swine Fever Virus antigen concentrate (VAC), suitable for long term frozen storage and finishing into ready-to-use Classical Swine Fever Virus Vaccine, for distribution in the United States within timeframe to be negotiated in a Delivery Schedule (7 days ideal). AND/OR

3. An Indefinite-Delivery/Indefinite-Quantity component for the delivery of Classical Swine Fever Virus Vaccine, DIVA, from existing inventories, suitable and eligible for distribution in the United States within timeframe to be negotiated in a Delivery Schedule (7 days ideal).

1.5 Additional requirements

1. Contractor has a USDA Product License or Permit for Distribution and Sale; OR

2. Contractor does not have a License or Permit for Distribution and Sale, following apply:

• When Contract awarded, submit to CVB:

• A plan for product licensing that shows commitment to obtain License or Permit

• Purity and safety data

• Reasonable expectation of efficacy data

• Properly formatted, complete Outline of Production (OOP); all work will be conducted according to the OOP on file at the CVB, in facilities accepted as suitable by the CVB.

• Within approximately 12 months after Contract awarded, submit to CVB:

• Potency test validation data or data showing potency test development progress

• Efficacy data or additional data supporting reasonable expectation of efficacy

• Immediately after product finished, submit to CVB:

• APHIS Form 2008 for each Serial, report Section V test results

• OOP Section V test results must be satisfactory

• Provide labels that comply with the 9 CFR 112 (e.g., state storage temperatures, warnings regarding destruction of unused contents for live products, slaughter withdrawal times, etc.), except the Establishment License number may be left blank until the Product License or Permit is issued

3. Unsatisfactory Serials will be replaced with Satisfactory Serials at the Contractor’s expense

4. The Contractor must supply a Material Safety Data Sheet for the Classical Swine Fever Virus Vaccine to the

CVB; it will be disseminated at CVB’s discretion.

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5. The Contractor will be responsible for all steps in the production, finishing, bottling, testing, and shipping of finished vaccine

1.6 Delivery Schedule

The initial 1,000,000 doses of CSFV vaccine need to be available 30 days after contract award. Alternative delivery schedule will be considered.

To meet surge requirements, the Contractor should provide for the production and delivery of at least 1 million additional doses of vaccine per week, for up to 20 weeks. As indicated in 1.4, the surge requirements state the doses that need to be delivered, within a timeframe to be negotiated in a Delivery Schedule. The corresponding Delivery Schedule requires availability of 1 million doses per week for 20 weeks; this is the ideal Delivery Schedule to meet surge requirements.

Based on the various methods of vaccine supply, alternative Delivery Schedules may be considered. Please include any alternative delivery schedules in your submission as indicated in Section 3.1.2 (Technical Proposal Instructions).

1.7 Offeror qualifications

The Offeror will be required to have the specific knowledge and expertise necessary to perform the work to be conducted which includes the following:

A) Offeror has a United States Veterinary Biologics Establishment License and a United States Veterinary Biologics Product License OR Permit for Distribution and Sale of the RVFV Vaccine; OR

B) Offeror does not have a License or Permit for Distribution and Sale, following apply:

1. When Contract awarded, submit to CVB:

a. A plan for product licensing (showing commitment to obtain License or Permit)

b. Purity and safety data

c. Reasonable expectation of efficacy data

d. Properly formatted, complete Outline of Production (OOP)

2. Within approximately 12 months after Contract awarded, ability to submit to CVB:

a. Potency test validation data or data showing potency test development progress

b. Efficacy data or additional data supporting reasonable expectation of efficacy

3. Immediately after product finished, ability to submit to CVB:

a. APHIS Form 2008 for each Serial, report Section V test results

b. OOP Section V test results must be satisfactory

**Please note: The NVS will not exclude bids from Offerors that do not hold current establishment or product approvals (licenses or permits) from the CVB; however, full payment will be withheld until a License or Permit is obtained.

2.0 CONTRACT ADMINISTRATION

2.1 Delivery order

Delivery orders will be issued against this contract on a firm fixed price bases at the quoted price.

Orders will be placed by a warranted contracting officer.

2.2 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. The 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 (FMS).

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.

Solicitation AG-6395-S-14-0137---Classical Swine Fever (CSF) Vaccine Page 5 of 25 https://ipp.gov/

2.3 Points of contact

For questions regarding general contract administration, please contact Larry Nelson, Contract Specialist, at 612-336- 3225 or larry.d.nelson@aphis.usda.gov.

Technical Point of Contact information will be provided at the time of award.

2.4 Ordering authority

Orders will be placed by a warranted contracting officer.

2.5 COR and technical points of contact

For questions regarding general contract administration, please contact Larry Nelson, Contract Specialist, at 612-336- 3225 or larry.d.nelson@aphis.usda.gov.

Technical POC’s will be provided upon award of the contract.

The Contracting Officer (CO) has designated a Contracting Officer’s Representative (COR) who will be identified at the time of contract award.

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IV. CONTRACT TERMS AND CONDITIONS:

52.212-4 -- Contract Terms and Conditions -- Commercial Items. (May 2014)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights --

(1) Within a reasonable time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C.3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71,Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at FAR 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include --

(i) Name and address of the Contractor;

(ii) Invoice date and number;

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(iii) Contract number, contract line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer— System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by

EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment.

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt Payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C.

3903) and prompt payment regulations at 5 CFR Part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-5(b) for the appropriate EFT clause.

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(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected contract line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period at fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

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(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in 32.608-2 of the Federal Acquisition Regulation in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government’s convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor’s records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

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(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 41 U.S.C. 4712 and 10 U.S.C. 2409 relating to whistleblower protections; 49 U.S.C. 40118, Fly American; and 41 U.S.C.

chapter 21 relating to procurement integrity.

(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:

(1) The schedule of supplies/services.

(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause.

(3) The clause at 52.212-5.

(4) Addenda to this solicitation or contract, including any license agreements for computer software.

(5) Solicitation provisions if this is a solicitation.

(6) Other paragraphs of this clause.

(7) The Standard Form 1449.

(8) Other documents, exhibits, and attachments.

(9) The specification.

(t) System for Award Management (SAM).

(1) Unless exempted by an addendum to this contract, the Contractor is responsible during performance and through final payment of any contract for the accuracy and completeness of the data within the SAM database, and for any liability resulting from the Government’s reliance on inaccurate or incomplete data. To remain registered in the SAM database after the initial registration, the Contractor is required to review and update on an annual basis from the date of initial registration or subsequent updates its information in the SAM database to ensure it is current, accurate and complete. Updating information in the SAM does not alter the terms and conditions of this contract and is not a substitute for a properly executed contractual document.

(2)

(i) If a Contractor has legally changed its business name, “doing business as” name, or division name (whichever is shown on the contract), or has transferred the assets used in performing the contract, but has not completed the necessary requirements regarding novation and change-of-name agreements in Subpart 42.12, the Contractor shall provide the responsible Contracting Officer a minimum of one business day’s written notification of its intention to:

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(A) Change the name in the SAM database;

(B) Comply with the requirements of Subpart 42.12 of the FAR;

(C) Agree in writing to the timeline and procedures specified by the responsible Contracting Officer. The Contractor must provide with the notification sufficient documentation to support the legally changed name.

(ii) If the Contractor fails to comply with the requirements of paragraph (t)(2)(i) of this clause, or fails to perform the agreement at paragraph (t)(2)(i)(C) of this clause, and, in the absence of a properly executed novation or change-of-name agreement, the SAM information that shows the Contractor to be other than the Contractor indicated in the contract will be considered to be incorrect information within the meaning of the “Suspension of Payment” paragraph of the electronic funds transfer (EFT) clause of this contract.

(3) The Contractor shall not change the name or address for EFT payments or manual payments, as appropriate, in the SAM record to reflect an assignee for the purpose of assignment of claims (see FAR Subpart 32.8, Assignment of Claims). Assignees shall be separately registered in the SAM database. Information provided to the Contractor’s SAM record that indicates payments, including those made by EFT, to an ultimate recipient other than that Contractor will be considered to be incorrect information within the meaning of the “Suspension of payment” paragraph of the EFT clause of this contract.

(4) Offerors and Contractors may obtain information on registration and annual confirmation requirements via SAM accessed through https://www.acquisition.gov.

(u) Unauthorized Obligations.

(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End Use License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an Anti-Deficiency Act violation (31 U.S.C. 1341), the following shall govern:

(i) Any such clause is unenforceable against the Government.

(ii) Neither the Government nor any Government authorized end user shall be deemed to have agreed to such clause by virtue of it appearing in the EULA, TOS, or similar legal instrument or agreement. If the EULA, TOS, or similar legal instrument or agreement is invoked through an “I agree” click box or other comparable mechanism (e.g., “click-wrap” or “browse-wrap” agreements), execution does not bind the Government or any Government authorized end user to such clause.

(iii) Any such clause is deemed to be stricken from the EULA, TOS, or similar legal instrument or agreement.

(2) Paragraph (u)(1) of this clause does not apply to indemnification by the Government that is expressly authorized by statute and specifically authorized under applicable agency regulations and procedures.

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 date of award through last date of last option period exercised.

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(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.

52.216-22 -- 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 last day of last option period exercised.

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 one million doses, but not in excess of 20 million doses.

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 within 30 days; 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 5 years.

52.212-5 -- Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items. (Jul 2014)

(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) 52.222-50, Combating Trafficking in Persons (FEB 2009) (22 U.S.C. 7104(g)).

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

(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, 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 (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

___ (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).

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

_X__ (10) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (May 2012) (section 738 of Division C of Public Law 112-74, section 740 of Division C of Pub. L. 111-117, section 743 of Division D of Pub. L. 111-8, and section 745 of Division D of Pub. L. 110-161).

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

___ (12) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Jan 2011) (if the offeror elects to waive the preference, it shall so indicate in its offer)(15 U.S.C. 657a).

___ (13) [Reserved]

___ (14) (i) 52.219-6, Notice of Total Small Business Aside (Nov 2011) (15 U.S.C. 644).

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___ (ii) Alternate I (Nov 2011).

___ (iii) Alternate II (Nov 2011).

___ (15) (i) 52.219-7, Notice of Partial Small Business Set-Aside (June 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 (May 2014) (15 U.S.C. 637(d)(2) and (3)).

___ (17) (i) 52.219-9, Small Business Subcontracting Plan (Jul 2013) (15 U.S.C. 637 (d)(4)).

___ (ii) Alternate I (Oct 2001) of 52.219-9.

___ (iii) Alternate II (Oct 2001) of 52.219-9.

___ (iv) Alternate III (July 2010) 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)).

___ (20) 52.219-16, Liquidated Damages—Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

___ (21) (i) 52.219-23, Notice of Price Evaluation Adjustment for Small Disadvantaged Business Concerns (Oct 2008) (10 U.S.C. 2323) (if the offeror elects to waive the adjustment, it shall so indicate in its offer).

___ (ii) Alternate I (June 2003) of 52.219-23.

_X__ (22) 52.219-25, Small Disadvantaged Business Participation Program—Disadvantaged Status and Reporting (Jul 2013) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).

___ (23) 52.219-26, Small Disadvantaged Business Participation Program—Incentive Subcontracting (Oct 2000) (Pub. L. 103-355, section 7102, and 10 U.S.C. 2323).

___ (24) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15 U.S.C.

657f).

_X__ (25) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)).

___ (26) 52.219-29, Notice of Set-Aside for Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (Jul 2013) (15 U.S.C. 637(m)).

___ (27) 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__ (28) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

_X__ (29) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Jan 2014) (E.O. 13126).

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_X__ (30) 52.222-21, Prohibition of Segregated Facilities (Feb 1999).

_X__ (31) 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246).

_X__ (32) 52.222-35, Equal Opportunity for Veterans (Jul 2014) (38 U.S.C. 4212).

_X__ (33) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

_X__ (34) 52.222-37, Employment Reports on Veterans (Jul 2014) (38 U.S.C. 4212).

_X__ (35) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O.

13496).

___ (36) 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.)

___ (37) (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.)

___ (38) (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.

___ (39) (i) 52.223-14, Acquisition of EPEAT® -Registered Television (Jun 2014) (E.O.s 13423 and 13514).

___ (ii) Alternate I (Jun 2014) of 52.223-14.

___ (40) 52.223-15, Energy Efficiency in Energy-Consuming Products (Dec 2007) (42 U.S.C. 8259b).

___ (41) (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__ (42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011).

___ (43) 52.225-1, Buy American--Supplies (May 2014) (41 U.S.C. chapter 83).

___ (44) (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.

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___ (iv) Alternate III (May 2014) of 52.225-3.

_X__ (45) 52.225-5, Trade Agreements (Nov 2013) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

_X__ (46) 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).

___ (47) 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. 2303 Note).

___ (48) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

___ (49) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C.

5150).

___ (50) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505), 10 U.S.C. 2307(f)).

___ (51) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 4505, 10 U.S.C. 2307(f)).

_X__ (52) 52.232-33, Payment by Electronic Funds Transfer— System for Award Management (Jul 2013) (31 U.S.C. 3332).

___ (53) 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management (Jul 2013) (31 U.S.C. 3332).

___ (54) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

___ (55) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

___ (56) (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) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67.).

___ (2) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C.

chapter 67).

___ (3) 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).

___ (4) 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).

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___ (5) 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).

___ (6) 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).

___ (7) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495).

___ (8) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C. 1792).

___ (9) 52.237-11, Accepting and Dispensing of $1 Coin (Sep…