P03-23-007574 HHS JOFOC 20230915-Signed by OALM 20230927_Redacted.pdf

23-007574

b. Project Background.

The 12E Center for Cellular Engineering cGMP Facility will be the 4th Clinical Center cell processing lab, the first was opened in 1997. These new laboratories will provide cellular therapy services for Clinical Center (CC) Investigators and their patients on dozens of active protocols. The CC has purchased Sepax equipment in 2020 and 2021 and currently using the existing equipment Viafreeze, Viathaw and Sepax C-Pro devices and developed protocols.

Current Equipment:

Cell Separator Sepax 2 RM 6995.4290 Sepax 1 5B14 Cell Separator Sepax 2 RM 6994.1158 Sepax 2 2N307G Cell Separator Sepax 2 RM 7133.4158 Sepax 3 2N307G CRF VIA Freeze Quad VFQ0621510 CRF 10 3C709D2 CRF VIA Freeze Quad VFQ0321501 CRF 11 3C709D2 CRF VIA Freeze Quad VFQ0721501 CRF 11 3C709D2 Thaw VIA Thaw TBL0421204 Thaw 1 3C709D2 Thaw VIA Thaw TBL0421210 Thaw 2 3C709D2 Thaw VIA Thaw TBL0321201 Thaw 3 5B10

3. Description of the supplies or services the estimated value).

a. Project title. Cytiva Sepax, Viafreeze and Viathaw Devices with Delivery and Installation

b. Project description.

Four (4) Cytiva VIA Freeze Quad Controlled Rate Freezer with Accessories for the newly constructed Center for Cellular Engineering cGMP Facility

See Attached Statement of Work

Requirement type.

Research & development (R&D) R & D support services Support services (non-R&D)

X Supplies/equipment Information technology (IT) Construction Architect-engineer (A & E) services Design-build Other (specify): ____________________

Type of action.

X-New Requirement

Follow-on Other (specify): ______________________

Proposed contract/order type.

X- 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: POTS: 23-007574

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

This will be a onetime purchase and the independent government estimate for this project is

4. Identification of the statutory authority permitting other than full and open competition.

X This acquisition is conducted under the authority of 41 United States Code (U.S.C.) 253(c)(__) as set forth in Federal Acquisition Regulation (FAR) 6.302- 1.

This acquisition is conducted under the authority of section 4202 of the Clinger-Cohen Act of 1996.

This acquisition is conducted under the authority of the Services Acquisition Reform Act of 2003 (41 U.S.C. 428a).

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

Contractor:

Global Life Sciences Solutions USA LLC.

100 Results Way Marlborough, MA 01752

T- (800) 526-3593 URL: www.cytiva.com Cytiva is a brand of Global Life Sciences Solutions the parent company.

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

The Sepax C-Pro Cell Processing System, VIA Freeze and Via Thaw devices have been qualified for use in the Center for Cellular Engineering (CCE) Investigational New Drug (IND) protocols submitted to the Food and Drug Administration (FDA).

The FDA has approved the Cytiva equipment as part of FDA approved protocols and cannot be substituted. Attempts to qualify alternate devices are costly, time consuming and have not demonstrated comparability at the end of the study.

Only FDA qualified equipment can be utilized. Buying any other equipment would jeopardize research due to the risk of possible inaccurate interpretation of clinical results while creating delays for treatment for critically ill patients.

Global Life Sciences is the sole supplier of Cytiva equipment and the only vendor capable of performing a full installation and operational qualification of all equipment purchased. The contractor is the only source capable of performing all software installs and upgrades as this is Global Life Sciences, Cytiva proprietary equipment.

In addition, this specific equipment is needed for the new 12E Center for Cellular Engineering cGMP Facility which will be the 4th Clinical Center cell processing lab. The first facility was opened in 1997. Consistency of equipment for all four labs is required to support existing protocols. Additional equipment must be compatible with existing Via Freeze and Via Thaw equipment at the other CC Center for Cellular Engineering facilities for consistency and reproducibility of results and provide simplified program management. The contractor is the only source because the hospital needs a cGMP Facility with standardized equipment, supplies, training, disinfecting and maintenance to will help accommodate 43 Active Protocols 16 Complex Cell and Gene Therapy 20 Hematopoietic Stem Cell (HSC) Transplants 7 Collaborative Manufacturing And 14 New Protocols in Product Development

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR

5.202 applies.

To ensure that offers were solicited from as many potential sources as practicable, a pre-solicitation was published on 09/01/2023 through 09/07/2023, as required by FAR Sub Part 5.202. One response was received from KPaul on 09/05/2023. A review of the capability to provide the necessary equipment.

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

The program office independent government cost estimate was developed based on previous historical contract pricing for same or similar instruments.

Historical Workload Data/Previous Contract Awards Contractor: Global Life Sciences Award Date: 06/22/2021 Contract No.: 75N90021P00510 Award Amount:

Description: 3x Via Freeze Quad Controlled Rate Freezers and installation.

Contractor: Global Life Sciences Award Date: 09/29/2021 Contract No.: 75N90021P00787 Award Amount:

Description: VIA Thaw L1000, Chronicle 25 inclusive credits, Chronicle Pre-GMP Hosting setup, and Chronicle Gateway (SW license).

A review of the historical pricing found previous price paid for the Via Thaws were per unit and for the Via Freezes were purchased at per unit in 2021. The current pricing for the Via Freeze is . T increased from which is an increase of , which is

% increase over two years. The VIA Thaw 2021 pricing was per unit and which has increased in 2023 to per unit. This equates to an increase of

, which is an increase of % over two years increase is due the current market conditions with shortages of labor, increased gasoline prices, and inflation. The Consumer Price Index (CPI) for medical equipment and supplies is % found at the Bureau of Labor Statistics (BLS), New Release Table 7 for twelve months ending June 2023 and 3.7% for year ending Jan 2022 and transportation at 7.7% for twelve months ending June 2023 and for year ending Jan 2022 for twelve months is 23.4%. When comparing the contractors pricing to the and historical workload data, and is determined to be fair and reasonable. The contractor's pricing provides the best value and benefit to the government in fulfilling this requirement.

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 performed in accordance with FAR 10. On 05/30/2023 a notice of

Contract Opportunities on the www.sam.gov website that expired 06/10/2023. There were no responses or inquiries to the notice. A pre-solicitation notice was published on 09/01/2023 through 09/07/2023 of the intent to sole source to Global Life Sciences issued under NAICS 339112. One response was received from KPaul on capability to provide the necessary equipment.

Based on market research the only source capable of requirement is the original equipment manufacturer, Global Life Sciences. The new equipment must work independently and must be compatible with existing Cytiva equipment, methodology and practices qualified by FDA. Specifically, i.e. other SEPAX, Via Freeze and Via Thaw devices, as well as other equipment that is used upstream of these devices are compatible with the NIH infrastructure and has the capability of meeting the required equipment characteristics.

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

Not applicable

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

One vendor, KPaul expressed interest in writing. email was conducted and KPaul did not demonstrate the capability to meet the necessary requirements.

KPaul 6230 Corporate Drive Indianapolis, IN 46278

Socioeconomic Status: Service-Disabled Veteran-Owned Small Business

SAM UIE:

T-(

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

In the event this is an ongoing requirement, the government will continue to conduct market research to determine if the requirement can be competed.

12. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data