SOW.docx

STATEMENT OF WORK

1. Introduction

The Center for Cellular Engineering (CCE), DTM, and NIH CC is an AABB accredited cellular therapy laboratory whose central mission is to provide services to the NIH Institutes to support more than 50 intramural clinical trials. These services include (1) development, evaluation, and validation of investigational new drugs (INDs) for cellular therapies and (2) manufacture of cellular therapy products for approved clinical trials. The majority of these trials are early phase (I/II) trials not intended to result in the development of a commercial product. To provide these services, CCE operates a core facility for the manufacture, storage, and distribution of cellular therapy products. CCE manufactures cellular therapy products from more than 800 collections from patients or healthy donors per year. The products manufactured by the laboratory are used to treat NIH CC patients with cancer, hematological malignancies, marrow failure, genetic immune disorders and autoimmune diseases. All products are manufactured using good manufacturing practices (GMP). The NIH protocols are institutional review board (IRB) approved and in the case of INDs approval by the US Food and Drug Administration (FDA) for treatment of human subjects. Each subject must consent to participate in a NIH Clinical Research Study.

2. Scope

The subject contract shall cover preventive maintenance, support, and emergency servicing for two sets of BD FACSLyric flow cytometers and two sets of BD Lyse/Wash Assistants (LWAs) located on the 7th floor, building 10 at NIH, which is required to compliance with manufacturer and FDA 21 CFR 211.67. The LWAs are used to process licensed blood products and cellular therapy products before specific cell population of these products are characterized and differentiated in FACSLyric flow cytometers. With the help of these instruments, more than 15,000 samples are tested every year at CCE, which provides key information for these products to be licensed and to be released as regulated by the FDA.

3. Performance Requirements/Work Areas The contractor shall be responsible for, independently, and not as an agent of the government, providing all necessary personnel, supplies, materials and services for on-site preventive maintenance, inspection, certification and repair of Government-owned instruments and equipment identified here.

The contractor shall perform the following:

3.1. Equipment and Systems to be serviced

The following types of equipment and containment system components shall be serviced under this contract:

· Two (2) sets of BD FACSLyric flow cytometers

· Two (2) sets of BD Lyse/Wash Assistants (LWAs)

3.2. Service performance

· One (1) Preventive Maintenance Inspection will be performed per contract year.

· One (1) PM Kit will be provided.

· Software Revisions that are released during the Agreement term.

· Unlimited service visits during the term of this Agreement five (5) days per week.

· 24-hour guaranteed response to a request for emergency on-site service. If BD fails to meet the commitment, a $500.00 Response Time Credit will be issued.

· Unlimited telephone support for instruments, reagents and applications will be provided at no additional charge.

4. Work Manner and Time

· The contractor shall be responsible for scheduling annual certification and emergency work with the principal user with coordination through the COR.

· The contractor shall determine whether decontamination of equipment is necessary prior to commencement of work.

· The contractor shall comply with the appropriate laboratory practices and policies.

· The contractor shall observe the necessary safety precautions throughout the performance of this contract. Any additional personal protective equipment required for the safe performance of work shall be determined and provided by the contractor.

· Services shall be performed during normal working hours, 8:00AM to 5:00PM, Monday through Friday, local time, excluding Federal Holidays, except as specifically approved by the COR.

5. Labor and Travel The contractor shall provide all labor and travel at no additional cost for the duration of the contract.

6. IT Security Concerns

Please refer to the IT Security Form.

7. Contract Period: