Att4-SSJ_LMB-GPC3-LV-GMPproductionservice (signed)._Redacted.pdf

b. Project description.

The Contractor must accept the Government’s construct (pWPT-CT3- EGFRt) as transfer plasmid and lentiviral vector, produce the lentiviral product within six (6) months in full compliance to Good Manufacturing Practice (GMP) and Food and Drug Administration (FDA) regulations.

After product is made, the contractor will then also perform FDA-mandated long-term stability tests on the lentiviral product.

Requirement type.

Research & development (R&D) R & D support services Support services (non-R&D) Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify): ____________________

Type of action.

New requirement Follow-on: 75N91023P00290

Other (specify):

Proposed contract/order type.

Firm-fixed-price Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ Cost-plus-fixed-fee Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________ Other (specify): ___________

Completion Form Term form

Acquisition identification number.

Requisition #6939576

c. Total estimated dollar value and performance/delivery period.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

Prior to awarding this requirement, the Contracting Officer (CO) will make a determination that the price is fair and reasonable. It’s anticipated that this determination will be able to be made utilizing historical data for similar past requirements. However, the CO reserves the right to make this determination by any other means deemed appropriate in accordance with FAR 13.106-3 (a)(2).

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

Market research was conducted by both OA and the requiring Program Office. In addition to information provided by the requiring Program Office, market research included a thorough review of historical data of LMB’s previous procurement of lentiviral vectors from Expression Therapeutics, LLC, as well as other past NCI requirements for similar services. In addition to the past purchase of lentiviral vectors conducted by LMB, the review yielded four (4) previous commercial purchase orders for lentiviral vectors. Of these four (4) lentiviral vectors, three (3) were identified as being for clinical grade lentiviral vectors similar to the current procurement.

Efforts also included reviewing current pricing data that was able to be obtained from informal quotes, as well as publicly available information from various vendors websites who provide lentiviral plasmids and vector production services.

Research also included a review of required and recommended sources in accordance with FAR Part 8. As a result of this search, neither the required services, or the recommended vendor were not able to be identified as being available from these sources. Based on these findings a pre-solicitation notice of intent to sole source was posted as annotated above. As a result of these efforts only one (1) vendor was identified as meeting the Governments needs as expressed in the Statement of Work (SOW) for the required Lentiviral Vector.

9. Any other facts supporting the use of other than full and open competition.

All relevant facts supporting the utilization of procedures for other than full and open competition have been stated above.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

No other vendors except for the recommended vendor have expressed an interest in writing.