FSS-65-II-A - Zoll Respicardia Inc. - 36F79719D0009

The Department of Veterans Affairs

Federal Supply Service ‐ Authorized Federal Supply Schedule Price List

On‐line access to contract ordering information, terms and conditions, up‐to‐date pricing, and the option to create an electronic delivery order are available through GSA Advantage!, a menu‐driven database system. The INTERNET address for GSA Advantage is: GSAAdvantage.gov.

Medical Equipment and Supplies, FSC Group 65, Part II, Section A, FSC Class: 6515 Contract Number: 36F79719D0009

Contract Period: October 15, 2018 ‐ October 14, 2028 Incorporating Modification P00009 for Contract Extension

Contractor: Zoll Respicardia, Inc.

12400 Whitewater Dr, Suite 150

Minnetonka, MN 55343 Phone # 952‐470‐4474 Fax # 952‐540‐4485

Web Site: www.respicardia.com

Other Than Small Business

Contract Administrator: Seamus Jackson, Tel 952‐540‐4470, sjackson@zoll.com Alternate Contract Administrator: Andy Wolle, Rel: 952‐540‐4484, awolle@zoll.com

CUSTOMER INFORMATION:

1a. Table of awarded special item number(s) with appropriate cross‐reference to item descriptions and awarded price(s).

A‐72 Stimulators, Muscle, Nerve and Pain Control

1b. Identification of the lowest priced model number and lowest unit price for that model for each special item number awarded in the contract.

Please refer to the attached FSS Products/Price List Effective 6/1/2023.

2. Maximum order: $50,000

3. Minimum order: None

4. Geographic coverage (delivery area): The 50 U.S. States, Washington, DC, and Puerto Rico

5. Point(s) of production (city, county, and State or foreign country): US

6. Discount from list prices or statement of net price: Discount Range: 14.29% ‐ 33.33% Off of the Commercial List Price

7. Quantity/Tier discounts:

Quantity discount offered only for item #1001. Additional discounts are offered (for individual sales to an ordering activity) as follows;

4‐7 purchased, and additional 5% off the Commercial List Price (CLP), for a total of 20.00%

8‐11 purchased, an additional 5.4% off the CLP, so 20.40% total discount

12‐15 purchased, an additional 5.9% off the CLP, so 20.90% total discount

16‐plus purchased, an additional 6.2% off the CLP, so 21.20% total discount

8. Payment terms: Net 30 days

9a. Notification that Government purchase cards are accepted up to the micro‐purchase threshold: Yes; credit cards accepted below and equal to MPT with maximum amount of $100,000

9b. Notification whether Government purchase cards are accepted or not accepted above the micro‐purchase threshold: Yes; credit cards accepted above the MPT with maximum amount of $100,000

10. Foreign items (list items by country of origin): None

11a. Time of delivery: 2 days ARO

11b. Expedited Delivery: One day after receipt of order (ARO). Government is responsible for difference in cost between standard and expedited delivery.

11c. Overnight and 2‐day delivery: One day after receipt of order (ARO). Government is responsible for difference in cost between standard and expedited delivery.

11d. Urgent Requirements: Government buyers can contact the Contractor to effect a faster delivery.

12. F.O.B. point(s): FOB Destination to 48 contiguous states, DC, Alaska and Hawaii. FOB POE for Commonwealth of Puerto Rico

13a. Ordering address(es):

Zoll Respicardia, Inc 12400 Whitewater DR, Suite 150 Minnetonka, MN 55343

13b. Ordering procedures: For supplies and services, the ordering procedures, information on Blanket Purchase Agreements (BPA’s), and a sample BPA can be found at the GSA/FSS Schedule homepage (fss.gsa.gov/schedules).

14. Payment address(es):

Zoll Respicardia, Inc 12400 Whitewater DR, Suite 150 Minnetonka, MN 55343

15. Warranty provision: See Attachment 2.

Return Goods Policy: See Attachment 1.

16. Export packing charges, if applicable: N/A

17. Terms and conditions of Government purchase card acceptance: Government purchase cards are accepted below, at, and above the micro‐purchase threshold with maximum amount of $100,000

18. Terms and conditions of rental, maintenance, and repair (if applicable): N/A

19. Terms and conditions of installation: Installation/Physician Training Requirement. See Attachment 5.

20. Terms and conditions of repair parts indicating date of parts price lists and any discounts from list prices (if applicable): N/A

20a. Terms and conditions for any other services (if applicable):

Training/Support Services: See Attachment 4

Software License Agreement: See Attachment 3

Other: At the discretion of the Government Agency or Ordering Facility, a Business Associated Agreement (BAA) or equivalent may be required during the procurement of products related to this contract. Any BAA determination will be made in conjunction with Agency procurement regulations, policies and procedures.

21. List of service and distribution points (if applicable): N/A

22. List of participating dealers (if applicable): N/A

23. Preventive maintenance (if applicable): N/A

24a. Special attributes such as environmental attributes (e.g., recycled content, energy efficiency, and/or reduced pollutants): None.

24b. If applicable, indicate that Section 508 compliance information is available on Electronic and Information Technology (EIT) supplies and services and show where full details can be found (e.g. contractor’s website or other location.) The EIT standards can be found at: www.Section508.gov/: N/A

25. SAM UEI: ET88RNQLK4R7

26. Notification regarding registration in SAM: Yes, registered in SAM.

Zoll Respicardia, Inc.

Contract: 36F79719D0009 Prices Effective 9/15/2023

Incorporating Modification P00009 for Contract Extension

SIN# Item # Product Name / Description UOI FSS Price with IFF

A‐72 1001 remede Implantable Pulse Generator (IPG). Model 1001 is a multi‐ programmable stimulator designed for unilateral, transvenous phrenic nerve stimulation to treat moderate to severe central sleep apnea. This is a required part of a fully implantable system. The device monitors the patient’s respiratory signals and provides electrical stimulation to the left or right phrenic nerve to restore patients to a normal breathing pattern during sleep. The remede IPG contains electronic circuitry components and a battery, which are hermetically sealed in a

EA $25,628.14

A‐72 1100 remede EL Implantable Pulse Generator (IPG) Model 1100 multi‐programmable stimulator designed for unilateral, transvenous phrenic nerve stimulation to treat moderate to severe central sleep apnea. This is part 1 of 2 of a fully implantable system. The device monitors the patient’s respiratory signals and provides electrical stimulation to the left or right phrenic nerve to restore patients to a normal breathing pattern during sleep. The remede IPG contains electronic circuitry components and a battery, which are hermetically sealed in a titanium case. This is the extended longevity model.

EA $27,638.19

A‐72 1600 remede EL‐X Implantable Pulse Generator (IPG) Model 1600 multi‐programmable stimulator designed for unilateral, transvenous phrenic nerve stimulation to treat moderate to severe central sleep apnea. This is part 1 of 2 of a fully implantable system. The device monitors the patient’s respiratory signals and provides electrical stimulation to the left or right phrenic nerve to restore patients to a normal breathing pattern during sleep. The remede IPG contains electronic circuitry components and a battery, which are hermetically sealed in a titanium case. This is the extended longevity version and includes a single lead, single port

EA $27,638.19

A‐72 3102 respistim R Stimulation Lead; 24mm dia. Model 3102 is a hexapolar, transvenous, stylet delivered lead used with the remede Implantable Pulse Generator to deliver right sided phrenic nerve stimulation for the treatment of moderate to severe central sleep apnea. This is part 2 of 2 of a fully implantable system. The lead is designed for use with a stylet to remove the distal bias and permit delivery of the lead into the desired target vein. The lead has a 25 mm distal spring length; 24 mm distal coil diameter.

EA $9,045.23

A‐72 3103 respistim R Stimulation Lead; 20mm dia. Model 3013 is a hexapolar, transvenous, stylet delivered lead used with the remede Implantable Pulse Generator to deliver right sided phrenic nerve stimulation for the treatment of moderate to severe central sleep apnea. This is part 1 of 2 of a fully implantable system. The lead is designed for use with a stylet to remove the distal bias and permit delivery of the lead into the desired target vein. The lead has a 35 mm distal spring length; 20 mm distal coil diameter.

EA $9,045.23

A‐72 3652 respistim R Stimulation Lead; 24mm dia. Model 3652 is a hexapolar, transvenous, stylet delivered lead used with the remede Implantable Pulse Generator to deliver right sided phrenic nerve stimulation for the treatment of moderate to severe central sleep apnea. This is part 2 of 2 of a fully implantable system and is for use with the 1600 IPG only. The lead is designed for use with a stylet to remove the distal bias and permit delivery of the lead into the desired target vein. The lead has a 25 mm distal spring length; 24 mm distal coil diameter.

EA $10,050.25

A‐72 3653 respistim R Stimulation Lead; 20mm dia. Model 3653 is a hexapolar, transvenous, stylet delivered lead used with the remede Implantable Pulse Generator to deliver right sided phrenic nerve stimulation for the treatment of moderate to severe central sleep apnea. This is part 2 of 2 of a fully implantable system and is for use with the 1600 IPG only. The lead is designed for use with a stylet to remove the distal bias and permit delivery of the lead into the desired target vein. The lead has a 35 mm distal spring length; 20 mm distal coil diameter.

EA $10,050.25

A‐72 4065 respistim LQS Stimulation Lead. Model 4065 is a quadripolar, transvenous, over‐ the‐wire stimulation lead used with the remede Implantable Pulse Generator to deliver left sided phrenic nerve stimulation for the treatment of moderate to severe central sleep apnea. This is part 2 of 2 of a fully implantable system. The lumen of the lead is continuous, permitting the passage of a 0.014 in. guide wire for delivery into the desired target vein.

EA $9,045.23

Zoll Respicardia, Inc.

Contract: 36F79719D0009 Prices Effective 9/15/2023

Incorporating Modification P00009 for Contract Extension

SIN# Item # Product Name / Description UOI FSS Price with IFF

A‐72 4165 respistim LQS Stimulation Lead Model 4165 is a quadripolar, transvenous, over‐the‐wire stimulation lead used with the remede Implantable Pulse Generator to deliver left sided phrenic nerve stimulation for the treatment of moderate to severe central sleep apnea. This is part 2 of 2 of a fully implantable system. The lumen of the lead is continuous, permitting the passage of a 0.014 in. guide wire for delivery into the desired target vein. The Model

4165 has a 4.8 french proximal lead bod

EA $9,045.23

A‐72 4665 respistim LQS Stimulation Lead Model 4665 is a quadripolar, transvenous, over‐the‐wire stimulation lead used with the remede Implantable Pulse Generator to deliver left sided phrenic nerve stimulation for the treatment of moderate to severe central sleep apnea. This is part 2 of 2 of a fully implantable system and is for use with the 1600 IPG only. The lumen of the lead is continuous, permitting the passage of a 0.014 inch guide wire for delivery into the desired target vein.

EA $10,050.25

A‐72 1002A remede System Programmer. Model 1002A is a touch screen tablet computer used by doctors to communicate with the remede implantable pulse generator (IPG) via inductive telemetry and allows for configuration of programmable settings, initiation of system testing and review of collected diagnostic data. Communication with the implanted device is achieved using the remede programming software and an external programming wand

(Model 1004A or 1004A‐F) connected to the programmer via USB cable.

EA $3,015.08

A‐72 1004A‐F The remede System programming wand. Model 1004A‐F connects to the remede System

Programmer via USB and provides a magnetic inductive communication link to the implanted device. The Model 1004A‐F provides an extended flexible antenna disc that is placed directly over the implanted device and also allows for real‐time IPG monitoring during a polysomnogram (PSG).

EA $1,005.03

A‐72 7120‐S respiguide 120 Degree Deliver System. Accessory to the remede system, and it is used during implantation of the respistim LQS stimulation lead. The Respiguide consists of a 7F outer guide catheter and a 5F inner angiographic catheter. The 7F outer guide catheter is used for intravascular introduction of interventional/ diagnostic devices into the peripheral vascular system. The 5F inner angiographic catheter is used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.

EA $502.51