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LivaNova USA, Inc.

Standard Terms and Conditions of Sale

1.    SCOPE & APPLICABILITY.  These Standard Terms and Conditions of Sale (“Standard Terms”) govern the sale of equipment and/or products (“Products”) by LivaNova USA, Inc. (“LivaNova” or “Seller”) to the buyer named in the purchase order (“Buyer”). The Products are identified in Buyer’s purchase order issued to Seller. Buyer accepts these Standard Terms by submitting a purchase order to Seller. Any separate quotation issued by Seller is subject to these Standard Terms. These Standard Terms, along with the quotation issued by Seller, if any, comprise the entire agreement between Seller and Buyer. The pre-printed terms and conditions on or referenced in any purchase order, and any Buyer standard terms of purchase, shall have no effect. Buyer is hereby notified of Seller’s express rejection of any terms inconsistent with these Standard Terms or to any other terms proposed by Buyer.  Neither Seller’s subsequent lack of objection to any terms, nor the delivery of the products or services, shall constitute an agreement by Seller to any such terms. Notwithstanding anything to the contrary, if Buyer and Seller execute a separate written contract for the sale of Products by Seller to Buyer, the terms and conditions of such separate contract shall govern the sale of the Products.

2.    PRICES.  Seller will sell the Products to Buyer for the list price in effect on the date LivaNova’s Customer Service Department receives Buyer’s purchase order (subject to any discounts granted pursuant to Section 4 below). Seller, in its sole discretion, may amend its Product list price at any time. All prices are subject to an annual increase set by Seller in its sole discretion.

3.    TAXES.  Product prices are exclusive of all sales, use and excise taxes, and any other similar taxes, duties and charges, which if applicable will be added to the invoice. If Buyer is a tax-exempt entity, Buyer shall submit tax exemption certificate(s) to Seller prior to placing orders. If Buyer is not a tax-exempt entity, Buyer is responsible for all sales and use taxes related to the purchase of Products.

4.    DISCOUNTS; ANTI-KICKBACK.  Seller may from time to time offer Buyer discounts or rebates (as those terms are defined under 42 CFR §1001.952(h)) on the Products, and it is Seller’s intent to comply with the Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)) and the Discount Safe Harbor and Warranties Safe Harbor regulations (42 C.F.R. 1001.952(h) and (g), respectively). Any discounts or rebates will be detailed on a separate Discount &/or Rebate Letter issued by Seller to Buyer, which is subject to these Standard Terms. Buyer shall: (i) fully and accurately disclose and report any and all discounts, rebates or other price reductions (including warranty items) to appropriate federal or state healthcare programs or as may be requested by the Secretary of the U.S. Department of Health and Human Services; (ii) provide information upon request to third-party reimbursement programs; and (iii) otherwise fully comply with the Anti-Kickback Statute and Safe Harbor regulations, as amended. Buyer will be solely responsible for determining whether any discount, rebate or warranty item it receives must be reported.

5.    PAYMENT TERMS.  Buyer shall pay all invoices for non-HLM systems within thirty (30) days after the date of invoice. Buyers shall pay all invoices for HLM systems within forty-five (45) days after the date of invoice. ‘HLM system’ refers to the Essenz or S5 HLM systems in their entirety, and not to their individual components or related accessories and disposables. All payment terms are subject to Seller’s approval of Buyer’s credit, at Seller’s discretion. Payments must be received by Seller by the payment due date. Acceptable methods of payment include ACH, check, GHX ePay, and AMEX BIP. Buyers paying via GHX ePay and AMEX BIP are subject to additional third-party terms and conditions under those programs. Buyer’s failure to adhere to additional GHX ePay and AMEX BIP terms may result in removal from those accelerated payment programs. Buyer may in good faith dispute invoices, provided that Buyer notifies Seller of such dispute within thirty (30) days after the date of invoice. Seller will assess a late fee of the lesser of 1.5% per month or the highest rate allowed by law on account balances outstanding for sixty (60) days or more. Buyer shall reimburse Seller for all costs incurred by Seller in enforcing its rights to payment hereunder, including reasonable attorneys’ fees and expenses. Seller reserves the right to withhold shipment of Products to Buyer if Buyer’s account is past due. Seller shall have a right of set-off as to any and all accounts between Seller and Buyer. Exceptions or deviations from these payment terms shall be solely at Seller’s discretion. 

6.    SHIPPING; TITLE; RISK OF LOSS.  All Products will be shipped Free Carrier All (FCA) LivaNova’s facility (Incoterms 2020®). Title to the Products and risk of loss or damage to the Products will transfer to Buyer upon Seller’s delivery of the Products to the carrier at the FCA delivery point. Seller will prepay freight and add the charges to the invoice.

7.    PRODUCT RETURNS.  Buyer shall promptly inspect the Products upon receipt. Buyer may return Products promptly following their inspection if the Products do not conform to the purchase order in either quantity or model number. Subject to the conditions and requirements for Product returns described herein, Buyer may also return to Seller eligible returnable Products. Products eligible to be returned must be unopened, in their original packaging/cartons and condition, with the original labels and in a saleable condition. Products not eligible for return include Products which are expired, abused, damaged, custom or identified as non-returnable, or which have deteriorated due to a cause beyond Seller’s control. Buyer must contact LivaNova Customer Service and obtain a Return Goods Authorization (RGA) number within the return notification period applicable to the Product: (i) for Implantable Products and Disposable Products, within fourteen (14) days after their receipt; (ii) for Products which are Equipment or Spare Parts, within ninety (90) days after their receipt. For all eligible returnable Products, Buyer must return the Products to Seller within thirty (30) days after the issue of the RGA number, with freight prepaid. Seller will charge Buyer a restocking fee for each returned Product, regardless of quantity or purchase price of the product returned: (i) for Implantable Products, a fee of $250; (ii) for Products which are Disposables, Equipment or Spare Parts, a fee of 10% of the invoiced amount. Following Seller’s receipt of the original Product at the LivaNova facility and Seller’s verification (via quality inspection) that the returned Product meets the return requirements herein, Seller will issue a credit to Buyer in the amount of the invoiced Product price.

8.    LIMITED PRODUCT WARRANTIES.  The warranties listed below apply to each Product based on the applicable product category. The warranties stated herein: (i) apply only when the Product is used in accordance with the Product’s instructions for use; and (ii) are the exclusive warranties for the applicable Product, and exclude and are in lieu of any and all other representations and warranties whether express, implied, statutory or otherwise, including any implied warranties of merchantability, fitness or non-infringement, all of which are hereby expressly disclaimed and rejected. The warranty remedies in this Section are Buyer’s sole and exclusive remedies for warranty claims and are in lieu of any and all other remedies.

8.1  Cardiopulmonary Products only: Seller warrants that the Products will be free from defects in material and workmanship for the applicable warranty period stated herein. For a period of twelve (12) months from the date of installation of Equipment, Seller will, at its option, repair or replace Equipment that Seller finds defective in materials or workmanship. For a period of twelve (12) months from the date of shipment of Disposable Products, Seller will replace Disposable Products which Seller finds defective in materials or workmanship. For a period of ninety (90) days from the date of invoice for Spare Parts, Seller will, at its option, repair or replace Spare Parts that Seller finds defective in materials or workmanship. This warranty excludes and Seller shall have no obligation with respect to any defect, damage or failure due to normal wear and tear, misuse, unauthorized alterations, accident, neglect, improper handling, improper maintenance and/or use of nonstandard accessory attachments. Seller does not verify the safety or efficacy and makes no warranties, express or implied, with respect to any non-Seller components included at Buyer’s request or any components or products used other than as expressly intended by their manufacturer.

8.2  VNS Therapy Products only: Seller warrants that the Products will be free from defects in materials and workmanship for the warranty period stated in the Limited Replacement Warranty in the Product instructions for use (IFU), subject to the terms, conditions and limitations set forth in such Limited Replacement Warranty. This warranty excludes and Seller shall have no obligation with respect to any defect, damage or failure due to misuse, accident (including dropping), defacing and/or improper handling. If the Product fails to meet the foregoing warranty, Buyer’s sole and exclusive remedy and Seller’s sole obligation is to replace the Product with the most comparable product then available. To initiate a warranty claim, Buyer shall return the Products after obtaining a Returned Goods Authorization number from Seller. All warranty claims are subject to confirmation by Seller’s Quality Assurance Department.

8.3  Advanced Circulatory Support (ACS) Products only: Seller warrants that the Products will be free from defects in material and workmanship for the applicable warranty period stated herein. For a period of twelve (12) months from the date of shipment of Equipment, Seller will, at its option, repair or replace Equipment that Seller finds defective in materials or workmanship. For a period of twelve (12) months from the date of shipment of Disposable Products, Seller will replace Disposable Products which Seller finds defective in materials or workmanship. This warranty excludes and Seller shall have no obligation with respect to any defect, damage or failure due to normal wear and tear, misuse, unauthorized alterations, accident, neglect, improper maintenance, and/or use of nonstandard accessory attachments or equipment, including the utilization of a Seller cannula with a pump or controller other than those provided by Seller.

9.    SUBSTITUTION.  Seller reserves the right to discontinue Products in its sole discretion. Seller will notify Buyer in event that any Product is discontinued and offer a substitute product, if available.

10.    PRODUCT RESTRICTIONS; INSTRUCTIONS FOR USE.  Buyer shall not modify or alter the Products in any way without the prior written approval of Seller. Buyer shall not distribute the Products or otherwise sell or transfer the Products to any third parties. Buyer shall conduct its business in compliance with all applicable laws, statutes, and ordinances and shall comply with all applicable governmental rules and regulations in force with respect to the Products. Buyer agrees to use the Products according to their applicable Instructions for Use (“IFUs”). 

11.    FORCE MAJEURE.  Seller shall not be liable for any failure or delay due to any cause beyond its control, including acts of God, fire, flood, earthquake, epidemic, national or regional emergency, strike, lockout, factory shutdown, labor slowdown, supply shortage, priority request, riot, war, civil unrest or embargo. In the event of shortage of supply of materials or goods for any reason, Seller may allocate its available supply among itself and its Buyers in a manner determined by Seller in its sole discretion.

12.    COMPLIANCE WITH LAWS.  The parties shall comply with all laws, regulations, rules and orders applicable to their respective businesses and their performance under these Standard Terms, including: Foreign Corrupt Practices Act; False Claims Act; Anti-Kickback Statute; Stark Law; Health Insurance Portability and Accountability Act (HIPAA), including the Privacy Rule and Security Rule; Health Information Technology for Economic and Clinical Health Act; California Consumer Privacy Act; Food and Drug Administration laws and regulations, including Food, Drug and Cosmetic Act and Prescription Drug Marketing Act, each as amended.

13.    BUSINESS ASSOCIATE AGREEMENT.  If, and to the extent, that Seller will access Protected Health Information while acting as a Business Associate for or on behalf of Buyer as a Covered Entity (as such terms are defined under HIPAA), the parties shall comply with the terms and conditions of the separate Business Associate Agreement located at https://www.livanova.com/getmedia/eac7e2e4-e22d-4097-aba2-c731c8729fec/hipaa-business-associate-agreement.pdf.

14.    EQUAL OPPORTUNITY.  When applicable, the parties shall comply with: (i) the EO Clause in Section 202 of Executive Order 11246, as amended, and the applicable regulations contained in 41 C.F.R. Parts 60-1 through 60-60 and Executive Order 13496, which are incorporated herein by specific reference; and (ii) the requirements of 41 C.F.R. § 60-300.5(a), which prohibits discrimination against qualified protected veterans and requires affirmative action by covered prime contractors and subcontractors to employ and advance in employment qualified protected veterans; and (iii) the requirements of 41 C.F.R. § 60-741.5(a), which prohibits discrimination against qualified individuals on the basis of disability and requires affirmative action by covered prime contractors and subcontractors to employ and advance in employment qualified individuals with disabilities.

15.    TRADE COMPLIANCE.  Buyer shall comply with all applicable U.S. export and import laws and regulations, including the Export Administration Act (50 U.S.C. §§ 2401 – 2420) and its Export Administration Regulations. Buyer shall not, directly or indirectly, export, re-export or trans-ship any software or related information, media, or products in violation of U.S. laws and regulations.

16.    GENERAL.  Buyer shall treat all Product pricing as confidential and shall not publish or otherwise disclose pricing information to any third parties. The relationship between the parties is that of independent contractors only. Nothing in these Standard Terms grants or will be construed to grant any rights, benefits, claims or remedies to any third parties. In no event shall either party be liable to the other party for any indirect, consequential, incidental, special or punitive damages, whether arising under contract, tort or any other theory of liability, even if advised of the possibility of such damages and regardless of whether such damages were foreseeable. All waivers must be in writing and signed by the party granting the waiver. Any failure or delay to enforce any provision of these Standard Terms will not be construed as a waiver of a provision. If any provision of these Standard Terms is invalid or unenforceable, the unaffected provisions will remain in effect and the invalid or unenforceable provision will be deemed modified so that it is valid and enforceable to the maximum extent permitted by law.

LivaNova USA, Inc. Standard Terms and Conditions of Sale (Nov 2023)