75N91022Q00169_Special Notice.pdf

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

Document Type: Special Notice of Intent to Sole Source Solicitation Number: 75N91022Q00169 Posted Date: 8/9/2022 Response Date: 8/15/2022

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 Office of Acquisitions (OA) plans to procure, on a sole source basis, the IL-4 reagent from CellGenix USA (One New Hampshire Ave. Ste. 125 Portsmouth, NH 03801-2907).

The response close date of this notice for this requirement is in accordance with FAR 5.203(b).

This acquisition will be processed under FAR Part 12 – Acquisition for Commercial Items and will be made pursuant to the authority in FAR 13.106-1(b)(1); and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 325414 – Biological Product (except Diagnostic) Manufacturing.

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 (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.

The vaccine clinical trial process is regulated by the FDA. In order to be FDA compliant, all doses of the clinical trial vaccine must be manufactured with identical ingredients. Although IL- 4 is a commercially available reagent, the Clinical Trial Team’s dendritic cell (DC) vaccine was produced with CellGenix-brand IL-4. Therefore, all subsequent batches of the vaccine must be manufactured with the same brand of Interleukin 4 reagent. Using a different brand IL-4 reagent would invalidate the vaccine trial data. To NCI’s knowledge, CellGenix is the only vendor capable of providing the CellGenix GMP rh IL-4 reagent. CellGenix does not use resellers for its GMP rh IL-4 reagent. It is imperative to the research of the Vaccine Branch that the specific brand of reagent is purchased in order to ensure FDA compliance.

This notice is not a request for competitive quotation. However, if any interested party, especially small businesses, believes it can meet the above requirement, it may submit a capability statement, proposal, or quotation, 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, August 15, 2022. All responses and questions must be in writing and emailed to Lena Lee, Contract Specialist, via electronic mail at lena.lee@nih.gov. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No collect calls will be accepted. In order to receive an award, Contractors must be registered and have valid, current Entity Record, including current Representations and Certifications, in the System for Award Management (SAM) through SAM.gov. Reference: 75N91022Q00169 on all correspondence.

mailto:lena.lee@nih.gov