UCONN - SOW.docx

Atlanta VA Health Care System Research and Development Service (Reprogrammed Stem Cells for Osteoarthritis)

STATEMENT OF WORK

This Statement of Work, effective as of the start of the contract, is a complete agreement on its terms between the United States Department of Veterans Affairs (VA) and "Service Provider". This document defines the scope, terms, conditions, and mutual responsibilities to which both parties agree. It encompasses all aspects necessary for the services described herein and does not require reference to any external contract or agreement

A. GENERAL INFORMATION

1. Title of Project: Reprogrammed Stem Cells for Osteoarthritis

2. Background:

The Veteran Health Administration Office of Research and Development has funded a multi-year research project entitled “Stem cell reprogramming for joint preservation to alleviate pain and promote function.” The research project requires unique cell lines derived from inducible pluripotent stem cells (iPSCs) to identify an unlimited source of stem cell line to consistently resolve osteoarthritic inflammation, and pain, and to slow disease progression.

The Atlanta VA Health Care System, Research and Development Service, seeks a multi-year (base year plus four option years) contract to provide iPSC lines from various donors and tissue sources to the Atlanta VA Medical Center, 1670 Clairmont Road, Decatur, Georgia, 30033. The vendor will provide iPSC cell lines from various tissue sources including chondrocytes and bone marrow of varying health, and multiple donors. The vendor will provide proof of successful reprogramming of these cell lines and will provide 3–5 clones per line. The vendor’s work, activities and performance will be under the direction of the Atlanta VA research faculty, Dr. Hicham Drissi. These research projects aim to identify and validate a novel cell line to relieve preclinical osteoarthritic pain.

3. Scope of Work:

Tissues and donors will be provided by the VA. The vendor will provide inducible pluripotent stem cells (iPSCs) derived from various tissues (including articular chondrocytes and bone marrow) and donors.

Demonstration of the successful reprogramming, the vendor, will be provided through standard imaging assays and immunocytochemistry and at least 3 clones per cell line will also be provided.

The iPSC reprogramming service price includes the delivery of 3–5 clones per cell line, each with 3 cryopreserved vials. SSEA4 and OCT4 immunocytochemistry are included for one clone of each iPSC line. Cryopreserved vials will be shipped back to the VA.

3.1. Deliverables: The vendor/Contractor agrees to the following deliverable dates:

· Deliver 18 iPSC lines (3 tissue sources with 6 donors each) over the course of the contract

· The Atlanta VA will send tissues to Vendor.

· Vensor will complete re=programing tasks using Sendai virus

· The iPSC reprogramming service price includes the delivery of 3–5 clones per cell line, each with 3 cryopreserved vials. SSEA4 and OCT4 immunocytochemistry are included for one clone of each iPSC line.

· Vendor will return items back to Atlanta VA.

· An invoice will be issued upon completion of each iPSC cell line.

3.2.Description of Tasks and Associated Deliverables:

Task One:

Task Two:

Task Three:

4. Contractor Requirements:

The source of the iPSCs must be reliable and consistent in their manufacturing of the iPSC lines and must be consistent with our already established cell lines within the lab to provide accurate comparisons with the ongoing work to establish a reliable and consistent cell source to relieve osteoarthritic pain in Veterans. The cells must originate from various donors and from tissues including articular chondrocytes and bone marrow of variable health. The cells must be reprogrammed with a Sendai virus, and returned to the Atlanta VA.. All work must be done in-house without subcontracting the work to a different vendor to provide a consistent and transparent handling pipeline.

8. Place of Performance: The vendor shall complete all work at their site of business.

9. Description:

10. Payment Terms: Invoices for services will be through Tungsten

11. Performance and Accuracy / Performance Monitoring: The Research Investigator, will monitor the vendor’s activities and performance, including successful reprogramming of cells (indicated by immunocytochemistry) within the specified timeframe of 4 months. Payment will be approved upon receiving the reprogrammed cells and proof of reprogramming at the Atlanta VAMC. The Research Investigator will meet with the vendor as needed to address any concerns with activities or performance. Any concerns will be addressed and resolved in a timely manner. dor. The Contracting Officer will be contacted as needed.

C. CHANGES TO STATEMENT OF WORK

Any changes to this SOW shall be authorized and approved only through written correspondence from the Contracting Officer. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of parties other than the Contracting Officer shall be borne by the contractor.

D. CONFIDENTIALITY AND NONDISCLOSURE

It is agreed that:

1. The preliminary and final deliverables and all associated working papers, application source code, and other material deemed relevant by VA which has been generated by the contractor in the performance of this task order are the exclusive property of the U.S. Government and shall be submitted to the Contracting Officer at the conclusion of the task order.

2. The Contracting Officer will be the sole authorized official to release verbally or in writing, any data, the draft deliverables, the final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the contractor. Any request for information relating to this task order presented to the contractor shall be submitted to the Contracting Officer for response.

3. Press releases, marketing material or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the Contracting Officer.

E. CLASSIFICATION/SECURITY

Purchase only, vendors will not install equipment/software or connect to the VA network at any time.

F. CONTRACTOR RULES OF BEHAVIOR

The Contractor shall adhere to all VAMC Atlanta policies and procedures including but not limited to Information Security, Privacy, and Safety. The Certification & Accreditation (C&A) requirements do not apply, and a Security Accreditation Package is not required