A1.b_Statement of Work.docx

Statement of Work

Title: Using transgenic mouse to generate human antibodies

SECTION 1 – BACKGROUND

CDC Influenza’s Division is responsible for the development of Candidate Vaccine Viruses (CVVs) based on circulating and novel influenza strains. The CVVs are generally inoculated into mice or ferrets to produce animal antisera. The antisera are used to assess the antigenicity of the CVVs by testing them against a wide range of influenza viruses. A long-standing concern, that in recent years has become particularly significant, is that the results from the animal sera do not always align well with the results from the tests performed using human sera. This discrepancy is largely due to the antibody repertoire generated in standard animal models being different from those found in humans. Therefore, CDC seeks to test a transgenic mouse model that is engineered with human immunoglobulin gene segments to produce humanized antibodies, with the goal of determining if the antibodies generated from that mouse model can better recapitulate the antibody repertoire from humans.

SECTION 2 – PURPOSE

Overall objective is to provide the Influenza Division with transgenic mice that express human antibody repertoire, which would be useful for assessing the efficacy of CVVs and developing antibodies.

SECTION 3 – SCOPE OF WORK

The Contractor shall provide the following:

(a) 50 transgenic mice for pilot testing

(b) 150 transgenic mice

(c) 50 transgenic mice

(d) Associated licenses, agreements, and quality documents needed to utilize mice in CVV research

SECTION 4 – TASKS TO BE PERFORMED

(a) 50 mice in the first 6 months

(b) 150 mice in the following 12 months

(c) 50 mice in the last six months

(d) License or MTA for use the animals for the influenza virus and vaccine research

VENDOR QUALIFICATIONS:

(a) Offers a transgenic mouse model that contains the entire human antibody repertoire in a single organism

(b) Proven history of using the mouse model for generating humanized antibodies

(c) The mouse model offered must be widely licensed by biotech and pharmaceutical entities that have replicated claims of humanized antibody response.

Final Deliverables must include:

(d) 50 mice in the first 6 months

(e) 150 mice in the following 12 months

(f) 50 mice in the last 6 months

(g) Quality control documentation accompanying each animal shipment

(h) License, MTA, and/or all required agreements for use the transgenic mouse model for the influenza virus and vaccine research

SECTION 5 – GOVERNMENT FURNISHED MATERIALS

The Government will not provide materials.

SECTION 6 – PERIOD OF PERFORMANCE

A. The period of performance for this requirement is as follow:

Six months from 9/1/2022 to 2/28/2023 Twelve months from 3/1/2023 to 02/28/2024 Six months from 3/1/2024 – 8/31/2024 Supplies will be delivered upon request by the Project Officer.

SECTION 7 – DELIVERABLES/REPORTING SCHEDULE

A. Reporting Schedule

(a) Orders for custom synthetic plasmids will be placed by CDC Project officer per Schedule of Deliverables table below (subsection B).

(b) All shipments under this agreement shall be accompanied by packing slips that shall contain the following minimum information:

(a) Name of supplier

(b) Contract number

(c) Date of purchase

(d) Date of delivery or shipment

(e) Purchase number

(f) Itemized list of animals provided

(g) Industry standard Quality Assurance documentation

B. Schedule of Deliverables

SECTION 8 – POINT OF CONTACT INFORMATION

The Point of Contact (POC) for this procurement is:

Charmaine McKenzie Centers for Disease Control and Prevention NCIRD, Influenza Division 1600 Clifton Road, Mail Stop H17-5 Atlanta, Georgia 30329-4027

Telephone Number: (404) 498-3852 Fax Number: (404) 639-2350 E-mail Address: buo4@cdc.gov

Preferred method of communication: Email

SECTION 10 – PAYMENT TERMS

Multiple partial payments up to the CLIN limits are expected.

SECTION 11 – MINIMUM VENDOR QUALIFICATIONS AND LEVEL OF EFFORT

Expertise in the generation of transgenic mouse that contain human antibody repertoire.

SECTION 12 – EVALUATION FACTORS

1. Technical Evaluation:

A. Demonstration transgenic mouse model that contains the entire human antibody repertoire in a single organism.

B. Wide publication and licensing of mouse model by multiple entities supporting claims of humanized antibody response.

1. Stronger consideration will be given to histories showing work with influenza viruses

2. Price Evaluation

A. A price analysis of the quote will be conducted to determine the reasonableness of the Contractor’s price.

B. Any quote should account for multiple shipments within the designated time periods, which can be listed as a separate line item.

C. Pricing for licensure, MTA’s, or other agreements must account for the durations listed or be perpetual. Clear consideration for publication and use of data after designated periods must be accounted for a perpetual license is not provided.