JOFOC-Miltenyi_Biotec.pdf

Justification for Other than Full and Open Competition

"Source Selection Information - see FAR and

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity. National Institutes of Health Clinical Center

b. Sponsoring organization. Clinical Center, Dept. of Transfusion Medicine

c. Project Officer information

• Project Officer name. Lacey Gholson/ (alt) Thai Truong,

• Mailing address. Center Dr. 10, Room 3C720 Bethesda, MD

• E-mail address. LGholson@cc.nih.gov (alt.)

• Telephone number. / 301-435-4801

2. Nature and/or description of the action being approved.

a. Acquisition purpose and objectives. The purpose of this acquisition is for the Cell Processing Section (CPS) to purchase the

MACSQuant Tyto system and accessories. Presently, there is a need for the isolation of antigen specific cells, especially for

T Memory stem cells which have demonstrated significant results in the treatment of malignancies. However, the available isolation system in C P S can only be used for the selection of bulk specific lineage cells and cannot the rare Tscm populations.

There is no other known instrumentation beyond the Miltenyi

MACSQuant Tyto with the ability to select and isolate the respective cells. Additionally, the appropriate accessories, ie., antibodies, buffers, tubings, bags, are required. Additionally, a clinical trial is currently on hold due to the lack of suitable cell isolation system. The MACSQuant

Tyto system is currently the only known system that can provide the appropriate cells for this purpose.

b. Project background.

The Cell Processing Section (CPS) of provides cellular therapeutics to support the treatment of patients in Clinic Center.

As starting material of cellular therapeutics, the cells must be sterile, viable and consistent. To date, T C R or CAR T cell clinical trials have largely employed tumor-redirected T cells derived from peripheral blood mononuclear cells (PBMC). This strategy simplifies the manufacturing process, but it also generates inconsistent cell products as the PBMC composition can significantly vary in individuals as a consequence of age, pathogen exposure and prior therapeutic treatments. Advances in our understanding of T cell biology have led us to the identification of rare cell populations endowed with enhanced therapeutic potential.

For example, tumor-redirected T memory stem cells (Tscm) have displayed substantial potential in the treatment of malignancies;

however, these cells cannot be isolated using conventional isolation methods, such as magnetic beads selection. Miltenyi's MACSQuant Tyto system is currently the only solution that can provide appropriate cells for our processing. Neither this nor other methods, including magnetic beads selection and Fluorescence-Activated Cell Sorting (FACS) , the MACSQuant Tyto system is unique in these ways.

3. Description of the supplies or services required to meet the agency's needs (including the estimated value).

a. Project title. To Procure the MACSQuant Tyto

Project description. Advances in our understanding of T cell biology have led us to the identification of rare cell populations endowed with enhanced therapeutic For example, tumor-redirected T memory stem cells (Tscm) have displayed substantial potential in the treatment of malignancies; however, these cells cannot be isolated using conventional isolation methods, such as magnetic beads selection. Miltenyi's MACSQuant Tyto system is currently the only known response that can provide the appropriate cells for our processing. Compared with other methods, including magnetic beads selection and Fluorescence-Activated Cell Sorting (FACS) , the MACSQuant Tyto system is uniquely qualified to provide the necessary cells for the treatment of malignancies.

• Requirement type.

• Research & development (R&D)

• R & D support sen/ices

• Support services (non-R&D)

Supplies/equipment

• Information technology (IT)

• Construction

• Architect-engineer (A & E) services

• Design-build

• Other (specify):

Type of action.

0 New requirement

• Follow-on

• Other (specify): _

• Proposed contract/order type.

0 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.

b. Total estimated dollar value and performance/delivery period. The following to be arranged for delivery upon co. receiving the purchase order:

Catalog # 1 130-103-931

Accessories

1 170-076-502

1 170-076-501

1 130-106-088

1 130-107-206

Shipping and Handling

Description Price MACSQuant® Tyto $300,000.00

MACS® GMP CD45RA-FITC 5 $ 3,945.00

MACS GMP CD127-APC 5ml $ 3,945.00

24 $ 3,375.00

MACSQuant® Tyto Buffer 1 x 100 $125.00

Freight costs

Total cost

$312,065.00

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

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

• This acquisition is conducted under the authority of section 4202 of the Act of 1996.

• This acquisition is conducted under the authority of the Services Reform Act of 2003 (41 U.S.C.

Demonstration that the proposed unique qualifications or the nature of the acquisition requires use of the authority cited.

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

Miltenyi Biotec, Inc.

2303 Lindbergh Street Auburn, CA 95602 Phone.:+1 530 887 7260

b. Nature of the acquisition and proposed unique qualifications of the contractor(s). One vendor has been identified for the purchase of the MACSQuant Tyto system. Miltenyi Biotec Inc. is the trademark holder and manufacturer of the MACSQuant Tyto system, which is currently the only solution that can provide appropriate cells for our processing. Compared with other methods, including magnetic beads selection and Fluorescence-Activated Cell Sorting (FACS), the MACSQuant Tyto system is unique in the following:

• The MACSQuant Tyto uses sterile closed cartridge to sort the cells, this meet the sterility requirement of FDA regulations,

• The system uses single-use cartridge for each individual product, and there is no shared flow path and sheath fluid, and no carry-over from sample to sample, so the cells will meet the identity requirement of the FDA (per FDA identity, viability, and sterility requirements are in 21

610.14)

• The MACSQuant Tyto uses micro-valve based technology;

this processing is gentle to the cells (<3 psi) and produces' cells with high viability. Therefore, the cells will meet the viability requirement of the FDA regulations.

• The cells will be stained using specific surface markers and sorted by MACSQuant Tyto system, the specific cells will be enriched with high purity; this step fulfills the purity requirement of the FDA regulations.

• All the sorting will be done in the closed cartridge, no aerosols will be generated; this will protect the processing staff and the facility.

• The entire clinical grade reagents to isolate specific cells are from Miltenyi, the provider of MACSQuant Miltenyi has optimized the procedures for using MACAQuant Tyto, disposables and reagents, if we use equipment from other vendor (if any), we will need to develop our own procedures, and we would have to execute a well-designed validation plan, which would take several months and would cost the government additional funds.

6. Description of 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.

No other company manufactures this product at this time.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable. Pricing will be evaluated prior to award for the proposed acquisition with consideration given to the best value to the government.

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

Due to requirements for Miltenyi Tyto and associated accessories, additional research will not be conducted. This is due to the fact that this source is the only manufacturer of this specialized instrument and its testing system for T stem memory cells used in the treatment of malignancies.

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

Vendor is uniquely qualified and no other manufacturer of this Miltenyi Tyto system.

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

No other company manufactures this product at this time.

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.

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 verifying the Government's minimum needs, schedule requirements and other rationale for other than and open competition, are accurate and complete.

Official Name & Title Signature Date

Project Officer j Gholson, AO

COR, DIM

Department Head

Dr, Harvey Klein, Chief, CC

13. Contracting Officer certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information data provided to support the rationale and recommendation for approval is accurate and complete.

Official Name & Title Signature Date

Contracting Officer

Barbara Taylor, Contracting Officer Branch Chief