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 therapy, the complex nature of therapy, and the critical care context in which therapy is used, Contractor has implemented a number of measures intended to support the safe and effective use of therapy and to reduce user errors, including, without limitation, (a) a training program, which may be provided in-person at Customer s facilities, virtually or otherwise as determined by Mallinckrodt and access to technical and customer support, (b) access to Contractor s medical affairs professionals for responding to medical inquiries, (c) access to other important materials (including, without limitation, the operating manual for the Delivery Device and the prescribing information for therapy, (d) software-based diagnostics, alarm controls, and set-up wizards on the Delivery Device, and (e) infrared information capture between the Delivery Device and the cylinder(s) containing nitric oxide to ensure, among other things, that (i) expired drug product is not inadvertently administered to patients, (ii) the cylinder connected to the Delivery Device contains the correct concentration of drug product, (iii) information relating to the administration of nitric oxide is captured to assist in the investigation of any adverse events, and (iv) to enable Customer to capture information regarding the administration of therapy in their electronic medical records. 7. Ownership of therapy. Customer acknowledges and agrees that therapy (including, without limitation, the cylinders in which nitric oxide and related calibration gases are provided and the Delivery Device(s)), is and shall remain the sole and exclusive property of Contractor. Title does not pass to Customer to any portion of therapy under this Agreement. Customer shall provide Contractor with prompt physical access to therapy Systems in Customer s possession or control upon request by Contractor. Customer shall not permit lien or other encumbrance of any kind on any portion of therapy provided to Customer hereunder. Customer shall be solely responsible for loss of or damage to any portion of therapy system in Customer s possession or control. 8. No Transfer of therapy Systems. Other than movement of therapy Systems within a single Customer facility, Customer shall not, under any circumstances, transfer, release, loan, lease, or lend any Systems or any portions thereof provided to Customer by Contractor without the prior written authorization of Contractor. Without limiting the generality of the foregoing, Customer may not transfer any therapy Systems delivered to a particular Customer facility to any other Customer facility. 9. Return of therapy Systems. If Customer s level of use of therapy system does not justify Customer s retention of all of therapy Systems previously provided to Customer, Customer agrees, upon request from Contractor, to make the therapy Systems designated by Contractor available for pick-up by Contractor within 10 days after Contractor s request. In addition, Customer shall promptly make available for pick-up by Contractor within 10 days after Contractor s request any therapy Systems for which Contractor has provided a replacement. 10. Invoicing, Review and Prompt Payment. a. Prompt Payment. The fees applicable to Customer s use of therapy are set forth in Exhibit A. Customer shall promptly review each invoice and make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR Part 1315. If Customer believes there is an issue with an invoice, including quantity (run-ons) issues, Customer is to notify Contractor s customer care center within 7 days after receipt of the invoice. If Contractor has not been notified of any issues within the stated notification period, the invoice shall be deemed correct and final and payment shall be due within 30 days of receipt of invoice (552.232-74, Invoice Payments). In addition to any other remedies that may be available to Contractor, Contractor shall have the right to suspend its provision of therapy under this Agreement if any invoice hereunder is more than 120 days past due. b. Review of Invoices; Adjustments for Run-Ons. Contractor shall issue invoices for Customer s use of therapy system in accordance with 9(a) above. Customer shall promptly review each invoice. If Customer believes that the Running Total stated on an invoice is incorrect due to a run-on of a meter, Customer shall notify Contractor on or prior to the 15th calendar day after the date of the applicable invoice by contacting Contractor s customer service center. Contractor may, upon reasonable verification of the run-on, reduce the Running Total by the actual number of hours determined by Contractor to have been incorrectly recorded. If Customer fails to notify Contractor that Customer believes the Running Total reflected in an invoice is incorrect within the time period stated above, the applicable invoice shall be deemed correct and final. c. Running Total of Hours Used. Contractor shall maintain a running total of the hours of therapy consumed by Customer throughout the Initial Term (the Running Total ). The Running Total will be updated each time Contractor processes a cylinder of nitric oxide collected from a Customer Facility and will be included on each invoice to Customer. 11. Audit Rights. Contractor shall have the right to audit Customer s use, handling, and storage of the therapy Systems at Customer s facilities, subject to being granted access to such facilities by Customer and which access shall not be unreasonably conditioned, delayed or withheld, to ensure Customer s compliance with the terms and conditions of this Agreement. Any such audit shall be performed with reasonable notice and conducted during normal business hours and provided that any records reviewed by Contractor shall be held in confidence. 12. Compliance with Laws. During the Term of this Agreement, the parties shall comply with all federal laws and regulations applicable to the performance of their respective duties hereunder, including, without limitation, the provisions contained within or promulgated pursuant to the Federal Food, Drug and Cosmetic Act, as amended by the medical device amendments, 21 U.S.C. § 301, et seq., and the safe harbor provisions published at 42 C.F.R. § 1001.952(h) pursuant to the federal anti-kickback statute, 42. U.S.C. § 1320a-7b. 13. Upon Termination. Within five business days after the expiration or earlier termination of the order document, Customer shall make available for pickup by Contractor all therapy Systems then in Customer s possession or control. After all therapy Systems have been returned to Contractor, Contractor shall issue a final invoice for therapy system used by Customer but not previously invoiced. 14. Limitations of Liability; Disclaimer of Additional Warranties. Except as expressly provided herein, Contractor does not make any warranties of any kind, express, statutory, or implied. No oral or written information or advice given by an employee or representative of Contractor shall create a warranty for any products. Furthermore, the Contractor will not be liable to the Government in a breach of warranty action for consequential damages resulting from any defect or deficiencies in accepted items. The Government s sole remedy in a breach of warranty action shall be refund of the product purchase price and/or replacement of the product. Therapy Services Description of Services Information The following terms and conditions, including Attachment 1, are to be incorporated and attached to all Customer task order documents: Provision of therapy to Customer Contractor s provision of therapy to Customer is expressly made conditional on the terms and conditions of Authorized Price List with Approved Terms and Conditions (the Agreement ). The terms of the Agreement supersede any conflicting or inconsistent provisions in Customer s contract document(s). Ordering and Information: For all orders and delivery information, please call Customer Care Department. Description of Services - ITEM/SERVICE therapy Services - 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 the Delivery Device ), (c) various maintenance and calibration items, accessories, and disposables, and (d) training, support, maintenance, pick-up and delivery, and other services, all as described in further detail below ((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. nitric oxide for inhalation portable aluminum cylinders: Size 88, 1963 liters @ STP of nitric oxide gas, 800ppm concentration Size D, 353 liters @ STP of nitric oxide gas, 800ppm concentration Use of Delivery Device meeting the criteria for the administration of nitric oxide set forth in the product label for purified calibration gases for calibrating the Delivery Device(s) Disposables, Adaptors, Parts, and Accessories Test Gas Program & Monthly System Check-Out Kits Information System Officer, Information Protection: The contractor will not have access to VA Desktop computers they will not have access to online resources belonging to the government. 3.           Privacy Officer: The Contractor will not have access to protected Patient Health Information (PHI) nor will they have capability of accessing patient information during the services provided to the VA and if removal of equipment from the VA is required, any memory storage device will remain in VA control and will not be removed from VA custody. All research data available for Contractor analysis is de-identified. 4.           Records Manager: a.           Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228. b.           Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. c.            Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records. d.           Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act. e.           Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract. f.            The Government Agency owns the rights to all data/records produced as part of this contract. g.           The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data. h.           Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.]. i.             No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules. j.            Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.
