75N91022Q00169_Sources Sought Notice.pdf

Title: Procurement of CellGenix GMP rh IL-4 Reagent for Cancer Vaccine Clinical Trials

Document Type: Sources Sought Notice Solicitation Number: 75N91022Q00169 Posted Date: 9/19/2022 Response Date: 9/21/2022

Classification Code: 6640 – Laboratory Equipment and Supplies NAICS Code: 325414 – Biological Product (except Diagnostic) Manufacturing

Contracting Office Address:

Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E136, Rockville, MD

20850, UNITED STATES.

Description:

The National Cancer Institute (NCI), Center for Cancer Research (CCR), Vaccine Branch (VB) requires CellGenix GMP rh IL-4 reagent for cancer vaccine clinical trials. The North American Industry Classification System code is 325414 – Biological Product (except Diagnostic) Manufacturing.

This notice is NOT a request for competitive quotation. This is an unrestricted Sources Sought Notice (SSN)/Request for Information (RFI) and is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the National Cancer Institute (NCI). The purpose of this Sources Sought Notice is to identify qualified business concerns, especially small businesses, that are interested and capable of performing the work described herein, as well as obtain market information for planning purposes. Information received will be considered solely for the purpose of determining the appropriate acquisition method, including whether a set-aside is possible.

Any interested party that believes it can meet the requirement, may submit a capability statement which shall be considered by the agency. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow the NCI to determine if the party can perform the requirement.

Responses must be received no later than 12:00PM EST, September 21, 2022. All responses must be in writing and emailed to Lena Lee, Contract Specialist, via electronic mail at lena.lee@nih.gov. No collect calls will be accepted. Reference: 75N91022Q00169 on all correspondence.

1.0 BACKGROUND

The National Cancer Institute (NCI), Center for Cancer Research (CCR), Vaccine Branch (VB) requires CellGenix GMP recombinant human (rh) IL-4 reagent for cancer vaccine clinical trials.

The VB Clinical Trials Team uses dendritic cell (DC) vaccines to conduct clinical trials.

Currently, there is a need to manufacture additional doses for a new trial and before submitting the trial data to the FDA. To do that, the ancillary reagents to manufacture the dendritic cell vaccine at the NIH Clinical Center should be prepared in advance. CellGenix-brand Interleukin 4 mailto:lena.lee@nih.gov

(IL-4) is one of such reagents that is critical to the vaccine manufacturing. There is no alternative to CellGenix GMP rh IL-4, as this clinical trial manufacturing process is regulated by the FDA and cannot be changed arbitrarily.

The importance of the upcoming study on the endometrial cancer has a public impact. In the NCI, currently no other studies are focused on endometrial cancer. This disease has only a few options and most of them have only modest activity leaving the patients without promising options. Also, the incidence and the mortality of endometrial cancer has been going up in the past decade while most of other cancers have made progress in the prevention, early diagnosis and treatment outcomes. Thus, securing CellGenix GMP rh IL-4 to manufacture the proprietary DC vaccines is essential to the Vaccine Branch’s mission.

2.0 SPECIAL ORDER REQUIREMENTS

The Contractor shall provide the following for the Clinical Trials Team of the Vaccine Branch:

• CellGenix GMP rh IL-4 USP 50 microgram vials Qty: 135 vials

2.1 PRODUCT FEATURES/SALIENT CHARACTERISTICS

The following product features/characteristics are required for the CellGenix IL-4 reagent:

• GMP recombinant human IL-4 reagent

• United States Pharmacopeia (USP) 50 microgram vials

2.1.1 ADDITIONAL REQUIREMENTS

• Quotes must include all shipping costs, including FOB origin.

2.2 DELIVERY / INSTALLATION

Delivery shall be within 8 weeks after Purchase Order award. All shipping/handling (including FOB) and delivery/installation fees shall not exceed quote amount. Prior to delivery, the Contractor shall notify the NCI Technical Point of Contact (TPOC), that the delivery has been sent and provide all necessary tracking information. Installation is not required. Reagent vials shall be delivered at the following address:

National Institutes of Health/National Cancer Institute 9000 Rockville Pike Bethesda, MD 20892

NCI Technical Point of Contact: [to be provided upon award]

2.3 DELIVERY GUIDANCE

Due to the current COVID-19 pandemic, the vendor must pay close attention to the following delivery instructions. Please be aware that due to the fluidity of the existing pandemic, instructions may be updated as needed after award.

The Contractors shall communicate and follow instructions from the Technical Point of Contact (TPOC) to coordinate delivery, installation and training.

The Contractor shall store or retain all supplies furnished under this order until notified by the

NCI Contracting Officer or Technical Point of Contact (TPOC) of a delivery date. The Contractor shall deliver supplies no later than 30-days after notification.

The Contractor shall not sell supplies furnished under this order to another company or party if the NCI is unable to accept delivery due to conditions related to COVID-19.

Training and installation as required by the Statement of Need may be delayed due to conditions related to COVID-19. If services provided under this order are delayed, the Contractor shall provide all services at different times and dates at no additional cost.

The Contractor shall direct all courier and delivery services – including those not operated by the Contractor (e.g. FedEx, USPS, UPS) – to follow the instructions in this section.

All companies delivering to the NIH main campus must comply with Commercial Vehicle Inspection Facility (CVIF) access procedures. Upon arrival, the CVIF will provide a list of buildings and loading docks to delivery personnel.

Deliveries will be logged in at the loading dock, and the loading dock contractor or Government personnel will attempt to contact the TPOC listed on the package. In the event that the TPOC is unable to accept the package, the delivery shall not be left at the loading dock station. The delivery must be returned to the Contractor, and the Contractor must coordinate with the TPOC to deliver on another date at no additional cost.

Deliveries can only be made between 6:00 a.m. and 4:00 p.m. EST, Monday – Friday, excluding federal holidays.

3.0 TYPE OF ORDER

This will be issued as a firm fixed-price purchase order.

4.0 PAYMENT

Payment shall made in full after the successful delivery and acceptance of the reagent vials by the NCI Technical Point of Contact (TPOC). Payment authorization requires submission and approval of invoices to the NCI Technical Point of Contact and NIH OFM.