IR Aliya EX System Statement of Work DRAFT.pdf

STATEMENT OF WORK

Request Name: Interventional Pulsed Electric field system

I. PURPOSE

The overall purpose of this request is to purchase replacement the generator system.

This request is required and a necessary asset in the Interventional Radiology Section for the Diagnostic Therapeutic Careline (MEDVAMC) 2002 Holcombe Blvd. Houston, TX. 77030.

II. SCOPE

Delivery and training only.

III. SALIENT CHARACTERISTICS:

• NSP-EXAPR, Aliya EX Generator 2.5

• (1) GTI-00009, Cardiac Monitor, Synchronization, IVY Model 7600

• (1) GTI-00076, Galvanize Generator Cart

Additional Items Included:

• Up to one (1) Year of Aliya 2.5 System Warranty

• Up to one (1) Year of Aliya 2.5 System Clinical Support

• GTI-00078, Inumi Flex PEF Ablation Pack

• GTI-00050, Aliya PEF Ablation Pack

• GTI-00054 Inumi Flex Needles

• GTI-00023, Aliya Needle 19G

IV. TRAINING:

• On-site Physician and Staff Training

V. PROTECTION OF PROPERTY:

None needed, delivery only.

VI. SITE CONDITIONS:

• INSPECTIONS AND ACCEPTANCE: The COR shall ensure all work is completed satisfactorily prior to acceptance. Disputes shall be resolved by the

DRAFT

Contracting Officer. LIMITED WARRANTY. COMPANY WARRANTS THAT THE

EQUIPMENT SHALL BE FREE FROM MATERIAL DEFECTS IN MATERIALS AND/OR

WORKMANSHIP AND SHALL PERFORM SUBSTANTIALLY IN ACCORDANCE WITH

THE APPLICABLE WRITTEN SPECIFICATIONS FOR THE EQUIPMENT PROVIDED

TO CUSTOMER, UNDER NORMAL USE AND REGULAR SERVICE AS PROVIDED IN

THE EQUIPMENT’S USER MANUAL, FOR A PERIOD OF TWELVE (12) MONTHS

FROM THE DATE OF INSTALLATION (THE “WARRANTY PERIOD”). COMPANY

DOES NOT WARRANT OR GUARANTEE ANY OUTCOME. NO OTHER EXPRESS OR

IMPLIED WARRANTIES ARE GIVEN TO CUSTOMER, INCLUDING, BUT NOT

LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS

FOR A PARTICULAR PURPOSE. THIS WARRANTY SHALL BE VOID AND OF NO

EFFECT IF CUSTOMER (1) REUSES CONSUMABLES, OR (2) ACQUIRES AND USES

CONSUMABLES NOT MANUFACTURED BY COMPANY IN CONJUNCTION WITH

THE EQUIPMENT.

VIII. DELIVERABLES: LOCATION

Deliver to 2nd floor Interventional Radiology section room 2A-509.

X. SECURITY REQUIREMENTS:

COMPLIANCE WITH LAW. Each PARTY represents and warrants that it shall comply with all applicable federal and state laws and regulations, including, without limitation, the Federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b, any applicable “exceptions” or “safe harbors” under the Federal Anti-Kickback Statute with respect to the AGREEMENT, and any state laws comparable to the Federal Anti-Kickback Statute. In particular, both PARTIES expressly acknowledge that the Federal Anti-Kickback Statute, prohibits “illegal remuneration” as defined therein, in connection with the provision of goods or services for which payment is made in whole or in part under Medicare. It is the intention of the PARTIES hereto that this AGREEMENT shall in all respects comply with the Discount Safe Harbor, 42 C.F.R. § 1001.952(h) or the Statutory Discount Exception, 42 U.S.C. § 1320a-7b(3)(A). CUSTOMER agrees that, if CUSTOMER is required to report its costs on a cost report, then (i) the discount must be based on purchases of the same good bought within a fiscal year; (ii) CUSTOMER must claim the benefit in the fiscal year in which the discount is earned or in the following year; (iii) CUSTOMER must fully and accurately report the discount in the applicable cost report; and (iv) CUSTOMER must provide, upon request, certain information required to be provided to the CUSTOMER by COMPANY. CUSTOMER represents and warrants that it has independently determined that the CONSUMABLES and EQUIPMENT are in the best clinical interest of CUSTOMER’s patients.

End of Scope of Work

DRAFT

STATEMENT OF WORK