19-003153_Attachment_1-SOW.doc

STATEMENT OF WORK

GENERAL INFORMATION

Title of Project:

Generation of Induced Pluripotent Stem Cell Lines (iPSCs)

Statement of Need and Purpose:

The National Institute on Aging (NIA), National Institutes of Health (NIH), Laboratory of Neurogenetics is in need of iPSCs, which shall be created from Peripheral blood mononuclear cells (PBMCs) with appropriate quality control (QC) metrics.

Period of Performance:

The ordering period shall be for 3 years following award.

SCOPE OF WORK

General Requirements:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below. The Contractor shall not provide a research and development service, rather it shall provide a production of goods service.

Specific Requirements:

The Contractor shall provide reprogrammed cells for the purpose of characterizing cell lines with morphological and genetic data to create a cell repository as an open resource for the scientific community.

The Contractor shall provide the following:

The Contractor shall provide cell recovery and mycoplasma testing for the PBMCs.

The Contractor shall provide human pathogen testing for the PBMCs.

The Contractor shall provide cell reprogramming and clone isolation.

The Contractor shall provide anywhere from 200 to 600 iPSCs, at the rate of 20 to 50 per month.

The Contractor shall provide two clones per sample.

The Contractor shall provide a test to determine pluripotency of each clone.

The Contractor shall provide a test to determine that there is a normal complement of human chromosomes for each clone.

LEVEL OF EFFORT:

Time spent on generation of clones is expected to be 14 weeks from receipt of PBMCs. Various QC measures should be no more than 9 weeks from clone generation. Multiple clones can be generated and analyzed in parallel.

TYPE OF CONTRACT

An ID/IQ contract is contemplated. Minimum and Maximum Order amounts will be determined at the time of award.

GOVERNMENT RESPONSIBILITIES

The Government will provide appropriate paperwork indicating patient consent. The Government will provide PBMCs containing at least 1 million cells/vial.

DELIVERY OR DELIVERABLES

Two colonies of iPSCs per PBMC vial will be cryopreserved at 1x10^6 cells per vial and delivered to the Government.

REPORTING REQUIREMENTS

The Contractor shall provide a report on the cell recovery, passage and initial testing of the PMBCs. The Contractor shall provide a report on the reprogramming and putative iPSC clone isolation, including gene expression, pluripotency, and karyotype for each clone.

OTHER CONSIDERATIONS

Travel:

The principal place of performance is the Contractor’s work site. Travel for contractor employees will not be necessary.

Key Personnel:

It is required that all Contractors involved with the National Institute on Aging community to work collaboratively with federal staff and other contractors towards the National Institute on Aging’s mission and other affected organizations and follow the direction of the Contracting Officer’s Representative (COR), and/or the designated Federal Project Manager(s)/Lead(s). This collaboration includes day-to-day activities, support, development, knowledge transfer and creating and sharing documentation when required.

Information System Security Plan:

Not Applicable

Data Rights:

NIA shall have unlimited rights to and ownership of all deliverables provided under this contract, including reports, recommendations, briefings, work plans and all other deliverables. This includes the deliverables provided under the basic contract and any optional task deliverables exercised by the contracting officer. In addition, it includes any additional deliverables required by contract change. The definition of “unlimited rights” is contained in Federal Acquisition Regulation (FAR) 27.401, “Definitions.” FAR clause 52.227-14, “Rights in Data-General”, is hereby incorporated by reference and made a part of this contract/order.

Section 508—Electronic and Information Technology Standards:

The contractor shall comply with Section 508 of the Rehabilitation Act (29 U.S.C. § 794d), as amended by the Workforce Investment Act of 1998 (P.L. 105-220), August 7, 1998.

Publications and Publicity:

Not Applicable Confidentiality of Information:

NIA is not providing any information or data of a personal nature about individual(s) or proprietary information data. Nor will private information be shared by the contractor.

Attachment 1 – Statement of Work