19-003153_Attachment_3_-_Proposed_TO_1_SOW.doc

STATEMENT OF WORK

PROPOSED TASK ORDER 1

Generation of induced pluripotent stem cell lines (iPSCs) In accordance with the Base Contract Statement of Work, the Contractor shall perform the generation of induced pluripotent stem cell lines and shipped to the Government.

NUMBER OF IPSCS ORDERED: 100

The following reporting requirements and deliverables shall be submitted for this task order:

Government Responsibilities

The Government will provide paperwork to the Vendor indicating patient consent.

The Government will ship to the Vendor Peripheral Blood Mononuclear Cells containing at least 1 million cells/vial.

Contractor Responsibilities

The Vendor will provide cell recovery thru density gradient centrifugation and PCR based mycoplasma testing for the PBMCs.

The Vendor will provide human pathogen testing via PCR testing and microbial analysis for the PBMCs.

The Vendor will provide their proprietary method of cell reprogramming and clone isolation.

The Vendor will deliver to the Government the quantity of iPSCs listed above.

The Vendor will deliver to the Government two clones per sample. Two colonies of iPSCs per PBMC vial will be cryopreserved at 1x10^6 cells per vial and delivered to the Government.

The Vendor will provide the pluripotency of each clone thru in vitro detection of surface markers and genetic/ epigenetic profiling.

The Vendor will provide a karyotype to determine that there is a normal complement of human chromosomes for each clone.

Reporting Requirements

The Vendor is to provide a report on the cell recovery, passage and initial testing of the PMBCs.

The Vendor is to provide a report on the reprogramming and putative iPSC clone isolation, including gene expression, pluripotency, and karyotype for each clone.

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Statement of Work, Task Order 1

ATTACHMENT 4