Statement of Work - Custom Gene Synthesis 2020 contract.docx

STATEMENT OF WORK

Contractor shall furnish supplies/services to provide Custom Gene Synthesis for conducting molecular biology research for the USDA ARS, Foreign Animal Disease Research Unit (FADRU), Plum Island Animal Disease Center.

BACKGROUND/SCOPE

The Foreign Animal Disease Research Unit (FADRU) performs research, development, and diagnosis of foreign animal diseases which requires the need to make recombinant plasmids that have specific nucleotide sequences of viral proteins, these proteins have specific mutations that disrupt one or more of the natural function of the protein, and allow for evaluating unknown protein function to determine specific mutations that should be introduced into the virus, in order to make rational next-generation vaccines.

The FADRU is slated for relocation to the National Bio and Agro-Defense Facility (NBAF) in Manhattan, KS by 2023. In preparation for the relocation, plasmids that were created on Plum Island under BSl-3 conditions, will be synthesized by gene synthesis in order to be relocated in a BSL-2 laboratory as part of a plasmid repository.

GENERAL SCOPE:

The FADRU has a requirement for gene synthesis to conduct molecular biology research and plasmid biorepository at Plum Island Animal Disease Center. Included in this requirement is custom gene synthesis, and gene point mutations. The proposed contract will support all gene synthesis needs. Individual requirements for gene synthesis will be submitted to the contractor. Due to the infinite potential gene synthesis involving any combination of nucleotides, individual project pricing will be based upon the agreed-upon pricing schedule along with project by project negotiation. Final project pricing will depend on the complexity of the requested gene variant. Complexity is defined and determined based on the following three factors:

1) Secondary structure of requested variant, non-double helix DNA structures are harder to synthesize;

2) Guanine-cytosine (GC) content of the DNA: a higher percentage of GC relative to adenine and thymine (AT) increases complexity and price;

3) Length of new synthesis in the variant 4) Length separating requested changes when more than one area are variants.

The above three factors consider the complexity of the gene variant, and are not independent variables, but variables that when taken together in the context of a variant, increase the complexity of the gene synthesis. Other factors that can decrease price are when variants are a series that are dependent on each other, in simple terms variant 1 has mutation 1, variant 2 has mutation1+2, variant 3 has mutation 1, 2, &

3. In this situation mutant 3 has three mutations, but only one mutation when using mutant 2 as a reference. In gene variant or mutagenesis pricing, this would constitute a group of variants, and would be discounted over a sole variant. In this case pricing will still depend on the complexity of the gene variant has defined but taking into consideration the group.

CONTRACT TYPE

An ID/IQ which shall provide for filling all actual requirements of designated Government activities for services during a specified contract period with time or duration to be scheduled by placing task orders with the contractor. Each task order issued against this contract shall have a separate period of performance. Funds will be obligated under each separate task order based on actual needs.

PERIOD OF PERFORMANCE:

The Government anticipates award of a one year fixed-price contract. The exact dates will depend upon the length of time required to make award, but are estimated to be 12/31/2020- 11/30/2021

PLACE OF PERFORMANCE:

The performance of this work shall be at the contractor’s facility.

No work shall be performed outside of the United States or in any locality outside of the jurisdiction of the laws of the United States.

GOVERNMENT FURNISHED PROPERTY:

The following Government property will be furnished for completion of the desired Delivery Orders:

Previously synthesized plasmid templates that are stored by the contractor or provided at the time of synthesis will be used as a starting point and for all future synthesis processing.

DELIVERY ORDER REQUIREMENTS:

1. FADRU will provide the contractor with the specific sequence that is to be synthesized and the scale to grow the plasmid

2. The Contractor shall provide sequencing data showing that the sequence is correct upon time of delivery.

3. The contractor shall keep all requested sequences confidential, and not make them available to any public or private entity without approval from the FADRU.

4. The contractor shall keep a stock of the synthesized sequence for a minimum of two years, unless otherwise agreed by both FADRU and the contractor. Before destroying any stock, the contractor shall notify FADRU, with the option to ship the stock to FADRU. The samples shall be stored by the contractor at -20 degrees Celsius.

5. Contractor shall supply completed gene synthesis as requested by FADRU in the plasmid that was requested. Delivery shall occur within 30 days of completion of sequencing for each task order. If delays or failed synthesis occur the contractor shall notify FADRU and request any necessary extension of delivery date.

PLACEMENT OF DELIVERY ORDERS:

Delivery Orders may be issued at any time during the period of performance, and shall be prepared by either the Procuring Contracting Officer (PCO) or an Administrative Contracting Officer (ACO) appointed after award. Delivery Orders will be issued only after the Government and Contractor have negotiated project pricing as described herein. Funding will be provided separately for each individual Delivery Order.

The minimum individual Delivery Order price shall be $250.00. The ordering limit for the period of performance is $960,000. Contractor is required to independently track total delivery order value to assure it agrees to total Delivery Orders would not exceed the period of performance ordering limit.

DELIVERY REQUIREMENTS:

Freight/shipping costs and time of delivery shall be determined on a project by project basis at the time of individual project price negotiations.

Delivery shall be made within thirty (30) days of Delivery Order award, to the USDA, ARS, NEA, PIADC, Attn. (Identified on each order), 40550 Rt. 25, Orient Point, NY 11957, between the hours of 8:00 a.m. to 3:00 p.m., Monday through Friday, excl. Federal holidays.

PLEASE NOTE: Warehouse is closed during lunch hours of 11:30am – 12:30pm EST.

INSPECTION AND ACCEPTANCE

The work shall be inspected and accepted on a case-by-case basis by the TPOC for each delivery/task order. Any performance issues shall be reported to the ordering CO.

INVOICING

The “Submit Invoice to” address for USDA orders is the Department of Treasury’s Invoice Processing Platform (IPP). The contractor must follow the instructions on how to register and submit invoices via IPP as prescribed in the previous communication from USDA and Treasury. All invoices are to be submitted via the electronic Invoice Platform. This is a mandatory requirement initiated by the U.S. Department of Treasury and you can find more information at this website https://www.ipp.gov/indes.htm. Please make sure that your company has registered at https://www.ipp.gov/vendors/enrollment - vendors.htm to establish your account.

The Contractor shall include this information, at a minimum, to comply with the proper invoice submission procedures identified in FAR 52.212-4 (g)1. Invoices that do not contain all proper information as described below will be rejected to the contractor for correction, re-numbering and re-dating of the invoice, and re-submission.

Invoices shall include the following:

1). Name and address of business concern;

2). Invoice number and date;

3). ID/IQ Contract number AND requisition number;

4). Description, quantity, unit of measure, unit price and extended price of the item(s) delivered;

5). Name(s) title, and phone number person to contact regarding the invoice.

CONTRACT ADMINISTRATION:

The PCO is the only person authorized to approve and make modifications to contract terms and conditions on behalf of the Government. ONLY THE PCO has such authority and Contractor acts at its own peril if it performs in a manner inconsistent with contract terms and conditions at the direction or suggestion of a person or entity other than the PCO.

Delivery Orders may be placed only by the PCO or any ACO appointed after award.

Primary Points of Contact:

Procuring Contracting Officer (PCO):

Althea Paul, Contract Specialist 301-504-0331 althea.paul@usda.gov Contracting Officer, USDA-ARS-NEA Administrative Contracting Officer (ACO): TBD Technical Point of Contact (TPOC):

Dr. Douglas Gladue, Research Microbiologist Phone: (631) 323-3131 Email: Douglas.Gladue@ars.usda.gov