Attachment 6 - Sample Task Order B-01.pdf

ATTACHMENT 6: SAMPLE TASK ORDER: ASSOCIATED WITH TASK AREA B: VIRUSES

IN VITRO ASSESSMENTS OF ANTIMICROBIAL ACTIVITY

SAMPLE TASK ORDER B01

“Determination of In Vitro Efficacy of Antiviral Candidates”

NOTE: Offerors proposing for Task Area B must include in their proposal a response to the following sample task order. There is no added value in submitting multiple proposals in a single Task Area. The Offeror should be encouraged to submit its best proposal – i.e., the one for which it has the highest qualifications and capabilities.

Offerors proposing for Task Area B must submit a proposal that includes information pertaining to Task Area B only.

The following Sample Task Order is provided to assess the Offeror’s capabilities to conduct and fulfill the requirements of the Statement of Work for projects of similar scope and size to be issued under contracts awarded in response to this solicitation. Although this Sample Task Order will NOT be awarded, Offerors are to include in their proposals a response that specifies the methods by which each Sample Task Order would be accomplished and include an associated budget. Offerors should refer to the Additional Technical Proposal Instructions and Additional Business Proposal Instructions for guidance regarding preparation of their proposals.

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

1. PRICES

This is a firm-fixed price type task order.

SECTION C – DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

Statement of Work

I. SCOPE

Determination of antiviral inhibitory effect and cytotoxicity of experimental antiviral compounds against a viral panel.

II. TECHNICAL REQUIREMENTS

Independently, and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, materials, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below.

The requirements for Task Area B defined in the base Statement of Work apply to all work performed under this Task Order.

In addition to the requirements laid out in the base Statement of Work, the Contractor shall perform the following:

1. Antiviral Screening

a. The Contractor shall store and maintain all candidate test articles provided to the Contractor by the Government or through a third-party under conditions specified by the COR.

b. The Contractor shall perform two hundred (200) antiviral in vitro screening assays of candidate test articles against one viral panel from Table 1.

Table 1– Viral Pathogens

c. Each antiviral screening assay shall include assessment of dose-response data for test articles (and known positive control) against a single specific virus in mammalian cells in culture, with simultaneous determination of the in vitro cytotoxicity.

d. The Contractor shall include a minimum of four concentrations of test article performed in duplicate to generate an inhibition curve for calculating 50% and 90% effective concentration.

Panel 1 Panel 2 Panel 3 Panel 5 Panel 6 Herpes Simplex Virus-1

Enterovirus- D68

Respiratory Syncytial Virus

Dengue Virus 1-4

Ebola Virus

Herpes Simplex Virus-2

Enterovirus-

Measles virus West Nile Virus Nipah Virus

Varicella Zoster Virus

Echovirus B29 Influenza Virus (H1N1, H3N2, H5N1)

Zika Virus Lassa Fever Virus

Cytomegalovirus Rhinovirus C Severe Acute Respiratory Syndrome Coronavirus (SARS)-CoV-2

Chikungunya Virus

e. The Contractor shall include a minimum of four concentrations of test article performed in duplicate to establish a cytotoxicity curve for calculating 50% cytotoxic concentration and selectivity index.

f. The Contractor shall ensure each assay has a positive control that gives a minimum SI value ≥ five (5).

g. The Contractor shall complete assays within thirty (30) calendar days upon receiving the candidate compound(s).

h. The Contractor shall run the efficacy, cytotoxicity and positive control in parallel (same time, same investigator, same laboratory).

i. The Contractor shall analyze dose-response data for test articles and known positive controls using a calculated Selectivity Index (SI) scale based on the selective inhibition of viral replication and cytotoxicity assessments for a specific virus.

2. Communication and Reporting

a. The Contractor shall conduct monthly teleconference calls with the COR to report on progress and provide minutes of each teleconference in accordance with the Reporting Requirements and Delivery Schedule.

b. The Contractor shall provide a Final Report in accordance with the Reporting Requirements and Delivery Schedule.

SECTION D – PACKAGING, MARKING, AND SHIPPING

There are no additional D. clauses applicable to this Task Order beyond those in the base contract.

SECTION E – INSPECTION AND ACCEPTANCE

There are no additional E. clauses applicable to this Task Order beyond those in the base contract.

SECTION F – DELIVERIES OR PERFORMANCE

1. PERIOD OF PERFORMANCE

The period of performance for this Sample Task Order is ten (10) months.

2. TASK ORDER REPORTING REQUIREMENTS AND DELIVERABLES

Technical Reports

All reports required herein shall be submitted in electronic format.

All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including guidance and specific checklists, by application, can be found at: http://www.hhs.gov/web/508/index.html under "Making Files Accessible."

1. Final Report

This report is to include a summation of the work performed and results obtained for the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved and shall include:

• Assay format

• Assay results calculated as 50% and 90% effective concentration, 50% cytotoxic concentration and selectivity index.

• Preparation, lot number, and handling of test articles

• Growth media, cell line, and culture conditions of the selected virus

• Control articles

The Final Report shall be submitted in accordance with the DELIVERIES Article in SECTION F of this task order.

Other Reports and Deliverables

All reports required herein shall be submitted in electronic format.

1. Compound Test Result Reports The compound Test Report shall include:

a. A title page containing

i. Sample Task Order number

ii. Test Site

iii. Experiment number

iv. Test compound name

b. Type of assay with brief details on set up

i. Virus Screened and isolate, including known provenance and passage details

ii. Cell line, including known provenance, passage details, and growth conditions

iii. Vehicle used for test and control compounds

iv. Documentation of preparation of test and control compound(s)

v. Test compound concentration range

vi. Control compound name

vii. Control concentration range

c. Results http://www.hhs.gov/web/508/index.html

i. EC50/EC90, CC50 and SI50/SI90

ii. Dose-response curve with error bars for test and control compound

iii. Cytotoxicity curve with error bars for drug and control compound

iv. Include a brief assay narrative of any salient observations

v. Any specific comments including description of any technical or performance problems encountered, along with proposed corrective action taken

d. Raw data in a tabular format from which the curves obtained

2. Monthly Teleconference Minutes The Contractor shall provide and deliver, in accordance with the Delivery Schedule, minutes of the monthly teleconferences which include the following:

a. List of action items (including who is responsible for the action item).

b. Summary of any high-level decisions made during the teleconference.

c. Number of assays performed and committed to date as well as remaining number of assays.

d. Summary of concerns raised during the teleconference and the plan to address these concerns.

e. Appendix including all Compound Test Result Reports finalized during that month.

TASK ORDER DELIVERY SCHEDULE

Item Report Recipient Delivery Schedule

1. Final Report 1 electronic copy to COR and CO.

Due on/before the completion date of the task order.

2. Compound Test Result Report

1 electronic copy to COR and CO.

Due on/before 30 calendar days following completion of testing on a compound.

Compounds completed during the final 30 days of this task order shall be submitted on the expiration date of the task order

3. Monthly Teleconference Minutes

1 electronic copy to COR and CO.

On or before 7 calendar days following the teleconference

SECTION G – TASK ORDER ADMINISTRATION DATA

There are no additional G. clauses applicable to this Task Order beyond those in the base contract.

SECTION H – TASK ORDER ADMINISTRATION DATA

There are no additional H. clauses applicable to this Task Order beyond those in the base contract.