Statement of Work.pdf

STATEMENT OF WORK

PART A: SPECIFIC REQUIREMENTS

I. GENERAL CONTRACT INFORMATION

Location:

Naval Hospital Guam (NHG) Building 50, 1st Floor IZ01 Farenholt RD Agana Heights, Guam 96910

II. WORK ORDER REQUIREMENTS

A. Background

The Navy Blood Program (NBP) is licensed by the Food and Drug Administration (FDA) to manufacture and distribute blood products, and is a component of the Armed Services Blood Program (ASBP). The NBP has the strategic goal for 2017 of implementing pathogen reduction technologies at all of the Navy Blood Donor Centers in an effort to minimize the risk of transfusion-transmitted infections and to prevent transfusion-associated graft-versus-host disease (TA-GVHD). As part of this effort, the NBP seeks to implement FDA-approved pathogen reduction systems for platelets and plasma at all Navy Blood Donor Centers (NBDCs).

B. Requirements

1. The pathogen reduction system shall be able to eliminate the need for bacterial testing of platelet units.

2. The system shall allow for immediate accessibility of platelet units, when used in accordance with the Instructions for Use.

3. The system shall allow the NBDCs to be able to produce two therapeutic platelet doses from a single INTERCEPT Dual Storage Processing Set.

4. The system shall allow the NBDCs to be able to pool two whole-blood derived plasma units to produce three-200 mL dose INTERCEPT Blood System processed plasma units.

5. The system shall be Federal Drug Administration (FDA) approved for the use with apheresis platelets and reduce the risk of microbial contamination in blood components, reducing transfusion-transmitted infections (TTIs) and sepsis risk, and reduce the number of T-cells to a level that potentially lowers the risk of TA-GVHD.

6. The system shall be FDA approved for use with whole blood-derived or apheresis plasma.

7. As part of the installation and deployment process of the system, the Contractor will provide a seasoned team to help the NBDCs transition smoothly to pathogen reduction, including in-depth training on the INTERCEPT system.

8. As part of the standard coverage the Contractor provides to purchasers of the contracted equipment, the Contractor shall provide all services, materials and equipment necessary for the repair/preventive maintenance of the Cerus Illuminators provided under the Contract as requested by the NBDC to ensure dependable and reliable equipment operation. The scope of work performed under these specifications includes the furnishing of all labor and parts to perform all repairs on equipment listed for twelve months and, to assure continued operation at their designed efficiency and capacity for such twelve months.

C. Conditions

1. The Contractor shall provide only fully qualified and authorized personnel who have been trained on the abovementioned equipment and can perform the services defined in the base Contract. Upon request, Contractor shall provide training certificates (or notarized copies) to the Contracting Officer for verification.

2. Immediately upon contract award, the Contractor shall provide Contracting Officer with an emergency telephone number for the Contractor. Contractor shall endeavor to respond within two hours after telephone notification Monday-Friday, hours of 0700-1800, Pacific Time, but in any case, no later than twenty-four hours from receipt of the call.

3. Equipment improvements/modifications shall be made only after the Contracting Officer has authorized the request in writing. Only the Contracting Officer can authorize and approve such requests on behalf of the Government.

4. Contractor shall notify the NBDCs and Contracting Officer within 24 hours of receipt of OEM or replacement parts/equipment safety recalls notices.

5. The Contractor shall ensure that original design and functional capabilities will not be changed, modified, or altered unless the

Contracting Officer in coordination with the NBDC authorizes such changes in writing; provided, however that Contractor is permitted to make any safety changes or other changes that are required by law or by regulation without such authorization. If the Contracting Officer, in consultation with the NBDC, does not authorize a proposed change in writing, then Contractor will not be deemed in breach of this contract or the associated award, for failure to perform any obligations hereunder.

6. As part of the standard coverage the Contractor provides to purchasers of the contracted equipment, the Contractor shall provide suitable OEM recommended repair equipment/tools required for the satisfactory execution of all repairs made for twelve months.

7. As part of the standard coverage the Contractor provides to purchasers of the contracted equipment, the Contractor shall furnish manufacturer OEM approved lubricants and lubricate wear points within the equipment for twelve (12) months.

8. The Contractor shall extend to the Government all commercial warranties on replacement parts that Contractor receives from the OEM of such replacement parts.

9. Unless otherwise agreed, the Contractor shall be responsible for its service related trip expenses including round trip travel, mileage, and overnight living expenses for twelve (12) months.

10. The Contractor may use Government utilities, (e.g., electrical power, compressed air, and water) that are available and required for any service performed under this Contract. The building engineer, to ensure compatibility with the NBDC's electrical wiring and equipment, shall approve the Contractor’s electrical equipment.

11. The Contractor shall be provided reasonable access to all equipment that is to be serviced and utility outlets required to perform the service. The Contractor shall be free to start and stop all primary equipment incidentals to the operation of the maintained equipment after permission is received from on-duty personnel responsible for such equipment.

12. NBDC employees will not perform maintenance or attempt repairs to equipment at any time unless agreed to in writing by the Contractor and coordinated with the Contracting Officer.

13. To ensure minimal equipment downtime, the Contractor shall maintain replacement repair parts and materials necessary to perform the most common type (based on Contractor’s experience) of repair or supply of said parts and materials within two business days of notification/diagnosis.

14. All compensation for labor is included in the contract price for twelve months. If service becomes necessary to be performed outside the normal work hours of the NBDC, the NBDC shall be notified prior to performance and agree to the performance of the work during the requested hours. Parts and materials: All compensation for parts and materials is included in contract price for twelve months.

15. Parts and Supplies provided under this Contract shall be new.

16. The Contractor shall report to Material Management Department, Biomed Repair Department, Building 50, Ground Floor, Room 1V01 Naval Hospital Guam, for Visitor Badges during the hours of 8:00 am – 4:00 pm Chamorro Standard Time, Monday through Friday, prior to and upon completion of any service/repair performed.

17. If, for reasons beyond the Contractor’s control, equipment is not made available for maintenance for the entire 30 days before maintenance due date, and 60 days following due date, the Contractor shall immediately notify the Contracting Officer.

18. Before the disposal, removal, or return of the equipment, any memory cards stored in the equipment shall be removed and provided to the NBDC for proper handling and destruction.

D. Constraints

All Contractor personnel shall be US Citizens.

E. Warranty Period

The standard warranty period of newly purchased equipment from the Contractor is 12 months from the delivery date and consists of non-severable maintenance and services.

F. Performance Hours

1. The Government anticipates giving the Contractor at least 72 hours’ notice before services are needed, however, shorter notice may be given due to circumstances beyond the Government’s control.

2. Upon notice of services needed, the Contractor shall arrive no later than two business days later to service equipment and has two business days thereafter to complete any repairs needed. If the repairs will take longer than two business days to complete, or if it needs to be shipped out for maintenance/troubleshooting, then the Contractor has three business days to deliver loaner equipment until the required service maintenance is completed.

3. Services are required to be available during regular work hours

(Monday through Friday, 7am-4pm, Chamorro Standard Time).

G. Preventive Maintenance and Repair Service Schedules

1. Preventive maintenance services will be performed at two times per fiscal year (October 1 through September 30) at 6-month intervals.

2. Repair services, when needed, will be performed Monday – Friday, between 8:00 am -4:00 pm Chamorro Standard Time.

H. FIELD SERVICE REPORTS:

1. Contractor shall furnish a written or electronic vendor supplied Field Service Report (FSR) to the Duty Staff at:

Naval Hospital Guam (NHG) Bio Medical Repair Building 1, Ground Floor, Room 1V01 Phone: 671-344-9373/9381

Or electronically at:

Usn.guam.navhospgu.list.nmd-contracting

2. The Contractor, or its representative, shall complete the vendor supplied FSR to include the following:

a. Contractor Name

b. Technician’s Printed Name, Telephone Number and

Signature

c. Date and Time of Arrival

d. ECN (Equipment Code Number) and Serial Number

e. Time Expended Repairing/Service; Labor Hours, Rate and Materials

f. Summary of Work Performed and Accepted by End-User (Government Representative’s Printed Name and Signature)

g. All Field Service Reports shall be submitted within 72 hours of completion of service

3. Completed FSRs are required before the Government will accept any invoice.

III. Terms and Conditions

A. Use of the equipment

1. The NBDC nor any personnel (collectively, “Customer”) shall not to use any equipment until a Contractor authorized representative has properly installed, calibrated and validated the equipment and trained Customer personnel in accordance herewith. At or before the installation of the equipment by Contractor, Customer shall make its personnel available for training on the use of the equipment, either at Contractor’s facility in Concord, California or on-site, as mutually agreed by the parties. Any additional training reasonably requested by Customer can be provided at a mutually agreed upon date and per diem rate.

2. Customer covenants and agrees to use the e quipment solely with the INTERCEPT Blood System platelet processing sets (the “Sets”) purchased or otherwise obtained by Customer from Contractor; and further covenants and agrees to use the equipment and the Sets solely to inactivate pathogens in platelets for transfusion to human patients in accordance with the Instructions for Use and applicable regulatory approvals (including without limitation any BLA license obtained or maintained by Customer) (collectively, the “Permitted Use”). For the avoidance of doubt, each of the following is expressly excluded from Permitted Use and Customer covenants and agrees not to use the equipment and/or any Sets: (i) with an active compound other than

Contractor-supplied amotosalen HCl or with treatment sets other than the Sets; (ii) in a manner that is outside the scope of the equipment’s regulatory approval in the United States; (iii) in a manner that is outside the scope of the license granted under subsection (d) below, the Instructions for Use or other instructions provided by Contractor; (iv) for the treatment of human blood or human blood components that will not be, or is not intended to be, transfused, unless expressly agreed by Contractor for purposes of validating or evaluating the INTERCEPT System; and

(v) with any substance other than human blood or human blood components.

3. Customer agrees (i) not to remove any components of the e quipment and/or disassemble the Equipment, (ii) not to remove the equipment from the facility at which it has been installed, without providing at least 30 days written notice to the Contractor and informs the Contractor about what will happen to the equipment. Customer agrees not to use the equipment six months following the last maintenance service provided by Contractor’s-certified Technical Service Representative.

4. Customer acknowledges that the components of the INTERCEPT Blood System and/or the procedures for which such system, including the equipment, may be subject to proprietary rights of Contractor and are protected by Contractor as identified trade secrets, patented inventions and/or copyrighted works.

Customer agrees not to remove or deface any proprietary legends affixed to or incorporated in the equipment (including, without limitation, any user documentation that may be supplied with the equipment). Subject to the terms and conditions hereof, Contractor hereby grants to Customer a non-exclusive license, during the Performance Period, to use the equipment solely for the Permitted Use. The foregoing license shall terminate immediately upon any termination by Customer; provided, however, that any restrictions on use set forth herein shall survive any such termination. Any use of the e quipment or Sets outside the scope of this license is expressly prohibited.

5. Customer expressly acknowledges and agrees that (i) it obtains no rights or privileges with regard to the use of the equipment other than those granted herein and (ii) the scope of the rights granted in the foregoing paragraphs was taken into account in setting the prices set forth in the Purchase Order and that higher prices would have applied had Customer desired broader rights.

B. Warranty. A warranty of one year is provided on services carried out by Contractor. Contractor will use commercially reasonable efforts to provide the services. All rights to warranty shall lapse under the following conditions: (a) inappropriate or improper use or handling contrary to Contractor's instruction of the equipment or goods supplied by Contractor; or (b) intervention on the equipment or goods supplied by Contractor, including, without limitation, service or maintenance, by the Customer or third parties not contracted by Contractor for that purpose. Should a covered defect occur and Customer notifies Contractor during the warranty period, Contractor's sole and exclusive obligation, and Customer's sole and exclusive remedy shall be, at Contractor's sole option and expense, to repair or replace the product.

Replacement products or parts may be new or reconditioned or comparable versions of the defective item. THE WARRANTIES SET

FORTH ABOVE ARE THE SOLE WARRANTIES PROVIDED BY

CONTRACTOR, AND EXCLUDE ANY OTHER WARRANTIES.

TO THIS END, CUSTOMER EXPRESSLY ACKNOWLEDGES

THAT THE GOODS OFFERED BY CERUS ARE STANDARD

AND NOT INTENDED TO SATISFY THE PARTICULAR OR

INDIVIDUAL NEEDS OF CUSTOMER. Any warranty claim against Contractor shall lapse after twelve months dating from the date the warranty claim arises, or earlier expiration of the applicable warranty.

C. Confidentiality. Customer agrees to maintain all information provided to Customer in connection with this transaction, including without limitation, the pricing, payment terms or special incentives or offers made by Contractor (collectively, the “Confidential Information”) in trust and confidence, not to disclose any Confidential Information to any third party, and not to use any Confidential Information, except in connection with this transaction.

Customer may, however, disclose Confidential Information to those specific employees within its organization (excluding affiliated entities) who have a need to know the particular information and who are bound by obligations of confidentiality. The above restrictions on disclosure or use of information do not apply to information which Customer can show: (a) is now, or hereafter becomes, through no act or failure to act on Customer’s part, generally known or available; (b) is previously known by Customer as evidenced by its written records; (c) is hereafter furnished to Customer by a third party, as a matter of right and without restriction on disclosure; or (d) is the subject of a written permission to disclose by Contractor. Notwithstanding the foregoing, nothing herein shall prohibit the disclosure of Confidential Information that is required in response to a valid order of a court or other governmental body of the United States or any political subdivision thereof, or otherwise required by law; provided, however, that Customer shall first have given notice to Contractor and shall have made a reasonable effort to obtain a protective order requiring that the Confidential Information so disclosed be used only for the purposes for which the order was issued.