SOW_BG_FBO.pdf

Statement of Work

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

ITEM

No.

SUPPLIES/SERVICES QUANTITY UNIT

OF ISSUE

UNIT

PRICE

USD

Extended

AMOUNT

1. Production and storage of FMD vaccine antigen concentrate (VAC) sufficient to produce 2.5 Million doses of formulated vaccines for a specified VAC. Cost must include storage of VAC for guaranteed shelf life at manufacturer.

2.5 Million Dose

(vaccine)

2. Production and storage of FMD vaccine antigen concentrate (VAC) sufficient to produce 2.5 Million doses of formulated vaccines for a specified VAC. Cost must include storage of VAC for guaranteed shelf life at manufacturer.

2.5 Million Dose

3. Option for conversion of stored VAC into formulated vaccine upon request and FOB destination shipment to any U.S., Canada or Mexico location. Pricing is valid for shelf life of VAC from date VAC has been released for use in bank.

2.5 Million

per VAC strain

Dose

SECTION C – DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

C.1 SPECIFICATIONS

The United States Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS) on behalf of the North American Foot and Mouth Disease Vaccine Bank (NAFMDVB), is seeking to secure the production of a foot and mouth disease (FMD) vaccine antigen concentrates (VAC), and as required, the opportunity to finish into final vaccine. The effective period of the contract will be the guaranteed shelf life of the VAC from date of release of the VAC and dependent upon successful performance in the efficacy test (PD50).

The contract will have the following components:

1. Production of FMD Vaccine Antigen Concentrates (VACs). Production of each FMD

(VAC) serial shall be purified and concentrated so as not to exceed 150 liters and shall provide 2.5 million doses. Please thoroughly review the Technical Annex for VAC suitability.

2. Storage of VACs on manufacturer premises

The Manufacturer will be required to store VAC for the guaranteed shelf life from date of acceptance to bank. VAC storage requirements are outlined in the Technical Annex.

3. Performance of quality control testing, and reporting of quality control testing results to the NAFMDVB Manager during the storage period.

The Contractor shall submit documentation on the manufacture, formulation, quality control and storage of the VAC(s) as detailed in the Technical Annex.

4. Submission of samples upon request under the conditions outlined in the Technical Annex This task includes the periodic submission of test samples to USDA APHIS VS upon request for safety, potency and efficacy testing. Please see Technical Annex for further details regarding vendor testing requirements and information about the testing performed by USDA.

5. Finish VAC into final vaccine if required.

Upon request from NAFMDVB, the vaccine(s) will be prepared using one or more of the VACs held by the NAFMDVB, singly or in combination, produced under this contract or previous NAFMDVB contracts still in effect.

C.2 Specifications/Milestones for Component 1: Production of FMD Vaccine Antigen Concentrates (VACs)

The Contractor will be responsible for the production of specified VACs, with the capacity to yield

2.5 million doses of finished vaccine. The specific VACs are not included in this document for purposes of National Security. Any CVB approved vendor that believes it may be capable of fulfilling this requirement should contact the Contracting Officer to identify the specific VACs for this particular acquisition.

C.3 Shipment/Delivery

All shipping and delivery costs associated with delivery of finished vaccine to any international airport in the U.S., Canada or Mexico, as designated at time of order, shall be included in the unit price of the VAC conversion cost. Sample Shipping and Delivery costs to USDA at either Plum

Island, NY or Manhattan, KS for testing shall be included in the unit cost of the VAC. Further details regarding the delivery and shipment terms for finished vaccine and sample submissions is included in the Technical Annex.

Finished vaccine shipments could be imported through any international airport in Canada, Mexico, or the United States using a direct flight from the country of manufacture or finishing.

Notifications of shipment should be made to the following individuals:

a. The Director of the National Veterinary Stockpile (NVS): Rodney White, office phone: (301) 851-3477; Mobile: (301) 789-3157; e-mail:

Rodney.A.White@usda.gov

b. The Director of Foreign Animal Disease Diagnostic Laboratory: Kimberly A. Dodd, office phone: (631) 323-3113, e-mail: Kimberly.A.Dodd@usda.gov

c. The Manager of the NAFMDVB: Hernando Duque, office phone (631) 323-3151, e-mail: Hernando.Duque@usda.gov

SECTION D. CONTRACT ADMINISTRATION

D.1 Acceptance Acceptance of VAC Once a VAC is released by the manufacturer and after completion of all the quality control tests for safety, innocuity, potency, and sterility, the contractor shall deliver the VAC(s) to the storage vessels on the contractor’s premises dedicated for use by the NAFMDVB.

At the time that the contractor delivers the VAC(s) into storage, the contractor shall also include the VAC samples for safety testing, innocuity testing, periodic 146S testing, and the preparation of trial blend vaccines. These ancillary VAC samples are to be stored together with the VAC.

The VAC identification (i.e. batch number, virus strain, date of manufacture, volume) shall be noted on each vial. Samples should be clearly identified in a permanent manner appropriate for liquid nitrogen storage conditions.

The NAFMDVB agrees to accept each VAC(s) in advance of the quality control tests that may be performed by the NAFMDVB as described in the Technical Annex. Documentation of the manufacturer’s testing procedures, results, and certificate(s) of analysis for the VAC will be provided to the USDA.

The record sheets for the inactivation kinetics for all the lots used in the preparation of the VAC and for the innocuity test, as well as the manufacturers test performed for the VAC release should be e-mailed to the NAFMDVB the day of the transfer of the VAC into long-term storage at the manufacturer.

Testing conducted by the NAFMDVB will be considered as the final official results. In the event that the tests performed by the NAFMDVB indicate a particular VAC covered under this contract does not meet the requirements for purity, safety, efficacy, or potency, the contractor must replace the VAC free of charge in a reasonable time period, not to exceed six (6) months after notification by the NAFMDVB of the test results as detailed in the Technical Annex.

mailto:Rodney.A.White@usda.gov mailto:Kimberly.A.Dodd@usda.gov

At the time of transfer, the manufacturer will send a report of the transfer indicating the serotype, virus strain, the serial or batch number, the volume or weight of VAC in the vessel, and the date the VAC was harvested.

Acceptance of Finished Vaccine

Finished vaccine acceptance will be deemed to have occurred upon delivery to the International Airport designated at time of order.

D.2 Period of Performance

The period of performance for this contract shall be the guaranteed shelf life from date of release of the VAC and dependent upon successful performance in the required testing further detailed in the Technical Annex. In the event of testing failure it may become necessary for the period of performance to be amended by contract modification to ensure the full guaranteed shelf life of viable VAC storage.

D.3 Invoicing

All invoicing will be submitted through the government electronic invoicing platform IPP.gov