Statement of Work Inhale Nitrate Therapy Services 1. PURPOSE 1.1 The overall purpose is to provide and install PSG Channel System, Software and Accessories at South Texas VA Health Care System (STVHCS), Audie Murphy VAMC, 7400 Merton Minter, San Antonio, TX. 78229. 2. SCOPE 2.1 The Contractor shall provide, transport, install, and test all listed equipment. All products must meet all salient characteristics defined in this section. 2.2 All equipment and installation must meet manufacturers and VA specifications. 2.3 The Contractor shall furnish all supplies, equipment, facilities and services required for delivery and installation of the supplies and equipment. 2.4 The Contractor is responsible for any missing parts and components not included in order to carry out the installation. Period of Performance: To establish a base year plus four option years to end in 2029. REQUIRED TERMS AND CONDITIONS, DESCRIPTION OF SERVICES AND PRICING INFORMATION FOR NITRIC OXIDE THERAPY SERVICES The following terms and conditions, including Exhibit A, are to be incorporated and attached to all Customer task order documents: Provision and Use and Required Terms and Conditions. 1. Provision of therapy. During the Term and subject to Customer s compliance with the terms and conditions of this Agreement, Contractor shall provide Customer with use of therapy Services, which consists of (a) the pharmaceutical drug nitric oxide for inhalation, (b) a delivery device meeting the criteria for the administration of nitric oxide set forth in the product label for therapy device (the Delivery Device ), (c) various maintenance and calibration items, accessories, and disposables, all as described in further detail in Exhibit A and (d) training, maintenance, pick-up and delivery, and other services, as described herein, including, without limitation, reimbursement support services ((a) through (d) collectively. For purposes of this Agreement, a therapy System shall include those items listed in subsections (a) through (c) of the previous sentence. 2. Warranty Regarding therapy Systems. Contract warrants and implies that the items delivered hereunder are merchantable. 3. Maintenance and Related Services. Contractor shall provide maintenance of therapy Systems as needed and as deemed necessary. Customer shall promptly notify Contractor in the event of any malfunction of any therapy System(s) in Customer s possession or control. All services provided by Contractor hereunder shall be performed in a professional and workmanlike manner. 4. Customer Facilities; Inventory Levels. therapy is provided on a facility-by-facility basis. Each facility may be provided one or more therapy System(s). Contractor shall determine, based on Customer s requests and volume of use during the Term, the number of therapy Systems or the number of any component of the therapy System (including, without limitation, the appropriate number of cylinders of nitric oxide to be held in inventory at each of Customer s facilities) that Contractor is able to provide to Customer at any given time. 5. Customer s Use of therapy. In order to maintain the proper operation of the therapy System(s) at Customer s facilities and to maximize patient safety, Customer shall (a) use the therapy System(s) only with equipment, devices, software, or other items with which they have been validated as reflected in the documentation for the therapy System(s), (b) permit only qualified personnel who have received adequate training to administer therapy, (c) comply with such instructions, warnings, documentation, guidance, or other recommendations as may be provided by Contractor, and (d) not modify any therapy System without Contractor s prior written consent. Customer acknowledges and agrees that regular checks of System(s) provided to Customer are essential to the continued proper operation of those systems. Accordingly, consistent with training provided by Contractor, Customer shall perform routine monthly system checks of the System(s) located at Customer s facilities. Customer acknowledges and agrees that Customer shall be solely responsible for determining, consistent with whatever standards or policies to which Customer s prescribing physicians may be subject, the uses and therapies for which Customer may utilize provided hereunder. 6. Safety and Training. Customer acknowledges and agrees that, as set forth in Section 1 of this Agreement, therapy is comprised of, among other things, an FDA-approved pharmaceutical drug that is administered through the use of a complex, FDA-cleared electro-mechanical drug delivery system. Customer acknowledges and agrees that therapy is typically used in a critical care context, where the proper use and administration of therapy may be essential to maintain blood oxygenation in critically ill patients with pulmonary hypertension. Customer further acknowledges and agrees that, in light of the multiple components that comprise th