TERMS AND CONDITIONS FOR SALE OF PRODUCT
MKT-000039 Rev C
- General. ALL SALES MADE BY NALU MEDICAL, INC. (“NALU”) TO THE BUYER (“BUYER”) FOR ITEMS LISTED ON THE BILLING FORM, PURCHASE ORDER, AND/OR INVOICE (THE “PRODUCTS”) ARE EXPRESSLY CONDITIONED ON BUYER’S ACCEPTANCE OF THE FOLLOWING TERMS AND CONDITIONS (THESE “TERMS AND CONDITIONS”), WHICH ACCEPTANCE MAY BE MADE BY WRITTEN EXECUTION OF THESE TERMS AND CONDITIONS OR BY RECEIPT BY BUYER OF DELIVERY OF ANY PRODUCTS. THESE TERMS AND CONDITIONS, TOGETHER WITH ALL EXHIBITS ATTACHED HERETO AND APPLICABLE PRICING PROPOSALS, CONSTITUTE THE ENTIRE AGREEMENT BETWEEN NALU AND BUYER AND SUPERSEDE ALL PREVIOUS NEGOTIATIONS, DISCUSSIONS AND UNDERSTANDINGS, WHETHER ORAL OR WRITTEN, BETWEEN THE PARTIES WITH RESPECT TO THE SUBJECT MATTER HEREOF. NALU WILL NOT BE BOUND BY ANY TERMS OF BUYER’S PURCHASE ORDER OR OTHER DOCUMENT THAT ARE ADDITIONAL OR INCONSISTENT WITH THESE TERMS AND CONDITIONS, AND ALL SUCH TERMS SHALL BE EXCLUDED. THESE TERMS AND CONDITIONS MAY ONLY BE AMENDED OR WAIVED BY A WRITING SIGNED BY AN AUTHORIZED REPRESENTATIVE OF NALU.
- Order and Acceptance. No order shall be binding upon NALU until accepted by NALU in writing, and NALU shall have no liability to Buyer with respect to purchase orders that are not accepted. Buyer shall submit purchase orders to NALU in accordance with NALU’s then-current lead times. After acceptance by NALU, Buyer’s purchase order may not be canceled or reduced in any amount by Buyer without NALU’s written consent. Any other changes to a purchase order requested by Buyer will require the prior written approval of NALU, which approval may be subject to price adjustments as determined by NALU on a case-by-case basis.
- Delivery, Shipping, Risk of Loss. NALU will use reasonable efforts to deliver Products at the times specified in NALU’s acceptance of Buyer’s purchase order, provided, however, that all delivery dates are estimates only and deliveries may be in installments. All Products shipped hereunder will be marked for shipment to Buyer’s address specified in Buyer’s purchase order and shipped FOB from NALU’s U.S.-based shipping point (“Delivery Point”), at which time risk of loss from any casualty and title pass to Buyer. If Buyer advises NALU in writing that Buyer will arrange and take responsibility for shipment of Products from NALU’s U.S.-based shipping point, NALU will arrange for Buyer’s freight forwarder and/or carrier(s) to transport the Products to Buyer’s specified location. In all cases of damage and/or loss to Products in transit, Buyer will be responsible for making claim(s) against the carrier; provided, however, that NALU will provide reasonable assistance with such damage and/or loss claims. Loss of or damage to Products shipped will not relieve Buyer of any obligations for payment or other obligations under these Terms and Conditions. Unless otherwise agreed by NALU in writing, shipping, freight, handling, insurance, and related costs are the sole responsibility of Buyer and will be “pre-paid and added” or otherwise invoiced to Buyer. Expedited purchase orders received and accepted by NALU by 3:00 P.M. Pacific Time will be shipped on the same business day, subject to Product availability.
- Price. Prices for Products shall be as set forth in the applicable Pricing Proposal agreed upon in writing (“Purchase Price”). NALU has the right to revise Purchase Prices upon advance written notice to Buyer. Price changes will apply to all purchase orders received after the effective date of the price revision.
- Disclosure of Discounts: In accordance with the discount provisions of the federal anti-kickback statute, 42 U.S.C. § 1320a-7b(b), and the discount safe harbor regulations at 42 C.F.R. § 1001.952(h), Buyer shall fully and accurately account for, and report on all applicable cost reports, the total value of any discount, rebate or other compensation paid in a manner that complies with all applicable federal, state and local laws and regulations which establish “Safe Harbor” for discounts as applicable, and as appropriate, under any applicable payer reimbursement requirements and provide information upon request to Medicare, Medicaid and other federal health care programs on all discounts and price reductions received from NALU. Buyer shall make written request to NALU in the event Buyer requires additional information from NALU in order to meet its reporting requirements. Buyer acknowledges that agreement to such reporting requirement was a condition precedent to NALU’s agreement to provide products and that NALU would not have entered into this Agreement had Buyer not agreed to comply with such obligations.
- No Charge Product. If a Product is provided to Buyer by NALU at no charge for evaluation or demonstration purposes, Buyer agrees to not bill any third party for the no-charge product, and if covered under a government reimbursement program, Buyer will not seek reimbursement under the billing procedures applicable to the payment system and/or the no-charge product must be treated appropriately under the billing procedures applicable to the payment system. Unless purchased, any unused product at the end of an evaluation period must be destroyed or returned per NALU’s instructions. If the Product is provided to Buyer in replacement of previously purchased Product, and if Buyer has previously billed for and/or sought reimbursement for the previously-furnished product, Buyer may not bill third parties for the replacement product and the replacement product must be treated appropriately under the billing procedures applicable to the payment system.
- Payment Terms. Provided that Buyer meets NALU’s credit requirements, payment terms shall be net thirty (30) days after the date of NALU’s invoice. Buyer will make payments in United States dollars by check or wire transfer to an account designated by NALU. Any invoiced amount not paid when due shall be subject to a service charge equal to the lesser of three percent (3%) per month or the maximum rate permitted by law. If Buyer fails to fulfill the terms of payment or does not meet NALU’s continuing credit requirements, NALU will have the option to decline to accept orders or fulfill pending orders, delay any shipment until payment for past orders is received by NALU, declare all outstanding sums immediately due and payable, and/or condition any future orders on terms specified by NALU. In the event of default in payment, Buyer will pay all costs of collection incurred by NALU including collection agency fees, attorneys’ fees, and court costs. All orders are subject to current credit approval.
- Taxes. In addition to the Purchase Price, Buyer will be responsible for payment of all taxes (including without limitation, withholding, excise, sales, value-added, and use taxes) and customs duties paid or payable, however designated, levied, or based, but exclusive of taxes based on NALU’s net income, unless Buyer provides a certificate of tax exemption to NALU.
- Substitutions and Modifications. NALU will have the right to make substitutions and modifications in the specifications or composition of Products or protocols related to Products sold by NALU, provided that such substitutions or modifications will not materially affect overall Product performance.
- Ownership, No Implied License. NALU retains all proprietary rights in and to all designs, engineering details, and other technology and information pertaining to the Products. The sale of Products ordered hereunder does not grant to, convey, or confer upon Buyer or Buyer’s customers, or upon anyone claiming under Buyer, a license, express or implied, under any patent right, copyright, or other intellectual property right of NALU covering or relating to any use other than is consistent with the labeling or instructions for use thereof.
- Software. NALU hereby grants a nonexclusive, nontransferable, limited license to use any software included within the Products, but only in conjunction with Buyer’s internal business use of the Products purchased hereunder. Purchaser receives no title or ownership rights to the software. Purchaser may not (a) modify, adapt, decompile, disassemble, or reverse engineer the software; (b) create any derivative works based on the software; (c) make any copies of the software, except for one copy solely for backup or archival purpose; (d) allow any third party to use or have access to the software; or (e) sell, transfer, assign or sublicense the software except as provided herein. Updates to the software may become available from time to time. Buyer agrees that NALU shall have the right to access applicable Products upon reasonable prior notice to install any and all such updates. If Buyer does not permit NALU to update the software in a timely fashion, NALU may void the applicable Limited Warranty.
- Product Training. As necessary to fulfill applicable regulatory requirements or otherwise assure the safe and effective use of the product, NALU will provide training and education to Buyer. Such training and education will be provided at no additional charge at Buyer’s location or other appropriate venue permitted by applicable law.
- Confidentiality. Buyer shall treat as confidential and proprietary, and shall not disclose these Terms and Conditions, pricing, discounts and/or any technical information provided by NALU to Buyer to any third party or otherwise make such terms public, unless such party receives the prior written approval of NALU or such disclosure is required by law.
- Limited Warranty. For Products purchased hereunder, NALU makes to Buyer the applicable limited warranty as set forth in Exhibit A (“Limited Warranty”). In addition to any limitations and contingencies set forth in Exhibit A, this Limited Warranty is contingent upon proper use of the Products in an application or individual for which it was intended and does not apply to any Product that is subjected to unusual physical or electrical stress, misuse, neglect, improper testing or storage, modification, used under improper protocol. NALU makes no warranty against any failure or defect, material or otherwise, of the Product related to, caused by, or exacerbated by any actions of Buyer, its employees, contractors, or any other end user.
- Limited Remedy. Buyer agrees that to obtain any replacement or refund of a Product for nonconformance with the Limited Warranty, (a) Buyer must promptly notify NALU in writing upon discovery that the Products failed to conform to the Limited Warranty with a detailed explanation of any alleged deficiencies, (b) Buyer must return the Products to NALU, and (c) NALU shall determine by examination of the returned Products that such alleged deficiencies actually exist and were not caused by accident, neglect, misuse, alteration by or of Buyer.
- Disclaimer of Warranties. EXCEPT FOR THE LIMITED WARRANTY STATED IN SECTION 14, THE PRODUCTS ARE PROVIDED “AS IS” WITHOUT WARRANTY OR CONDITION OF ANY KIND, EITHER EXPRESS OR IMPLIED, AND NALU SPECIFICALLY DISCLAIMS THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. No oral or written information or advice given by NALU or its employees will create a warranty or in any way increase the scope of the limited warranties set forth herein, and Buyer may not rely on any such information or advice.
- Mutual Indemnification. Each party shall defend, indemnify, and hold harmless the other party from and against any liability, damage, loss, or expense (including reasonable attorneys’ fees and expenses of litigation) in connection with any third party claims, suits, or proceedings for injury to or death of persons or damage to property to the extent arising out of such indemnifying party’s negligence or willful misconduct in connection with this Agreement in each case except to the extent caused by the indemnified party’s negligence or willful misconduct.
- Insurance. Buyer shall procure and maintain in force general liability insurance including property damage, bodily injury, products liability and contractual liability, in the minimum amount of $1,000,000 per occurrence and $3,000,000 in the aggregate.
- LIMITATION OF LIABILITY. NOTWITHSTANDING ANYTHING TO THE CONTRARY CONTAINED HEREIN, NALU’S LIABILITY AND BUYER’S REMEDIES ARISING OUT OF OR RELATED TO SALE OF THE PRODUCTS (WHETHER BY REASON OF BREACH OF CONTRACT, TORT, INDEMNIFICATION, OR OTHERWISE, BUT EXCLUDING LIABILITY OF NALU FOR BREACH OF WARRANTY (THE SOLE REMEDY FOR WHICH SHALL BE AS PROVIDED UNDER SECTION 13 ABOVE)), SHALL NOT EXCEED TWO (2) TIMES THE PURCHASE PRICE PAID BY BUYER FOR THE PRODUCTS GIVING RISE TO SUCH LIABILITY. IN NO EVENT SHALL NALU BE LIABLE FOR COSTS OF PROCUREMENT OF SUBSTITUTE GOODS, LOST PROFITS OR BUSINESS OPPORTUNITIES OR ANY OTHER INCIDENTAL, CONSEQUENTIAL, SPECIAL, OR RELIANCE DAMAGES, HOWEVER CAUSED AND UNDER ANY THEORY OF LIABILITY, WHETHER BASED IN CONTRACT, TORT (INCLUDING NEGLIGENCE), OR OTHERWISE. THESE LIMITATIONS SHALL APPLY REGARDLESS OF WHETHER NALU HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGE AND NOTWITHSTANDING THE FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY.
- Security Interest. NALU reserves a purchase money security interest in Products sold and the proceeds thereof, in the amount of the Purchase Price. In the event of default by Buyer in any of its obligations to NALU, NALU will have the right to repossess the Products sold hereunder without liability to Buyer. On request of NALU, Buyer will execute financing statements and other instruments that NALU may request to perfect NALU’s security interest.
- Return Product Policy. Authorization to return Products is required for all returns and shall apply only for Product that is non-conforming under the terms of the Limited Warranty.. A Return Goods Authorization number will be issued upon approval of the return and the number must be referenced on all returned packages. Non-conforming Product must be returned to NALU within thirty (30) days from the invoice date. NALU will examine the returned Product and determine whether it is non-conforming under the terms of the Limited Warranty. Product, including any Product that is opened (including the opening of and/or tampering with any packaging), damaged, expired or tampered with may, not be returned for credit at any time except when a Limited Warranty claim is made. Shipping damage claims must be made by Buyer directly with the shipping company in accordance with such company’s policies, and Buyer will advise NALU of such claims. Products which have been opened (including Products for which the packaging has been opened or tampered with in any way) – regardless of whether they were exposed to human tissue in any way, may be returned only by using an NALU-provided biohazard shipping bag and box (or similar) to ensure potentially biohazardous materials are properly quarantined to prevent exposure and/or contamination of processing personnel and in compliance with NALU’s Return Goods Handling Work Instructions.
- Term. These Terms and Conditions apply upon written agreement to a Pricing Proposal and shall continue in full force and effect until all Pricing Proposals have expired and/or terminated.
23. Compliance with Laws. Buyer shall comply with all federal, state and local laws, rules and regulations applicable to the purchase and use of Products. In addition, Buyer shall obtain all permits and licenses required by federal, state or local authorities in connection with any of the Products and shall bear all expenses in obtaining such permits and licenses or in complying with any related rules, regulations, ordinances and statues. Products are subject to the export laws and regulations of the United States and other countries. And diversion or re-export contrary to, or any violation of, applicable export control laws and regulations is prohibited.
- Miscellaneous. These Terms and Conditions contain the entire agreement and understanding between the parties on the subject of the sale of the Products. No representations or statements, other than those expressly set forth herein, were relied upon by the parties in entering into these Terms and Conditions. No modification or waiver of, addition to, or deletion from, these Terms and Conditions shall be effective unless reduced to writing and signed by duly authorized representatives of the parties hereto. By purchasing products from NALU, Buyer agrees that it is purchasing the Products only for its own use and not for purposes of resale. Products purchased pursuant to these Terms and Conditions may not be sold or transferred to any person or entity for purposes of resale. These Terms and Conditions shall be governed by and interpreted in accordance with the laws of the State of California, U.S.A. without reference to conflicts-of-law principles. Any dispute arising out of these Terms and Conditions shall be brought in, and the parties consent to personal and exclusive jurisdiction of and venue in, the state and federal courts within San Diego County, California. Failure or delay by either party in exercising any right hereunder shall not operate as, or be deemed a waiver of such right or of any other right hereunder, except for violations which, after discussion and mutual agreement by the parties, are waived in writing. Except for payment obligations, neither party shall be liable for damages for any delay arising out of causes beyond their reasonable control, including without limitation acts of God, labor disputes, riots, wars, component shortages. If any provision of these Terms and Conditions is held to be invalid or unenforceable, the remainder of these Terms and Conditions shall continue in full force and effect and will be interpreted to reflect the original intent of the parties.
LIMITED WARRANTY – NON-IMPLANTABLE COMPONENTS
Nalu Medical™, Inc. (” Nalu”) warrants that the temporary leads, trial cables, single-use accessories, disposable tools, chargers, and Therapy Discs included in the Nalu Neurostimulation System, hereafter referred to as Non-Implantable Components, are free from material defects in workmanship and materials for a period of one (1) year from the date of original purchase from Nalu, unless specifically noted. For clarity, this Limited Warranty with respect to a Non-Implantable Component is not extended if Nalu repairs or replaces such Non-Implantable Component.
If a Non-Implantable Component fails to operate or perform substantially in conformance with Nalu’s published specifications within one year after the original purchase date from Nalu, after Buyer contacts Nalu with respect to such warranty claim, Nalu will at its option repair or replace any Non-Implantable Component(s) so as to cause the same to operate in substantial conformance with said published specification. No other relief whatsoever is available under this Limited Warranty, and this Limited Warranty constitutes Buyer’s entire relief and Nalu’s entire liability with respect to such Non-Implantable Component. Claims under this Limited Warranty are subject to the following additional conditions and limitations:
- The product registration card for such Non-Implantable Component must be completed and returned to Nalu within 30 days of the procedure including such Non-Implantable Component.
- The Non-Implantable Component must be used before the “use before” date on its label, and in accordance with all written instructions provided by Nalu.
- Failure of the Non-Implantable Component must be confirmed by Nalu, in Nalu’s sole reasonable discretion.
- The Non-Implantable Component must be returned to Nalu (or Nalu’s authorized agent) within 30 days after it fails to operate or perform substantially in conformance with Nalu’s published specifications. That Non-Implantable Component will become Nalu property upon Nalu’s receipt of such Non-Implantable Component.
- This Limited Warranty does not include failures to operate or perform substantially in conformance with Nalu’s published specifications caused by:
(a) fire, floods, lightning, natural disasters, water damage and other calamities commonly defined as “Acts of God”;
(b) accident, misuse, abuse, negligence, or the failure to store, operate, properly handle, or otherwise use the Component in accordance with manufacturer’s instructions, whether by Buyer, patient, the healthcare provider that implanted the Nalu Neurostimulation System of which the Non-Implantable Component was a part in patient (“Healthcare Provider”), or other intervening acts by third parties;
(c) unauthorized attempts to repair, maintain, or modify the Non-Implantable Component by the Buyer, patient, Healthcare Provider, or any unauthorized third party; or
(d) body rejection phenomena, change in performance characteristics due to component changes or failures, unusual physiological variations in patient, medical complications; lead/extension dislodgment, lead/extension breakage, or breach of insulation, migration, or erosion of the area around the Non-Implantable Component;
(e) attaching equipment or other accessories to, or using such equipment or other accessories with, the Non-Implantable Component, in each case that are not supplied or expressly authorized by Nalu in writing.
Software. – If the Non-Implantable Component includes software provided by Nalu (“Software”), then Nalu warrants that any and all media on which the Software is delivered shall be free of material defects in material and workmanship for a period of ninety (90) days after such Software’s delivery from Nalu. Nalu has taken commercially reasonable steps to ensure that all Software is free from computer viruses, intentional or unintentional that disable, harm or otherwise disrupt computer systems or networks upon delivery from Nalu. However, Nalu accepts no liability in respect to any loss, cost, damage, inconvenience or expense suffered as a result of any computer viruses or other disruptions of computer systems or networks.
LIMITED WARRANTY – IMPLANTABLE COMPONENTS
Nalu Medical™, Inc. (referred to as Nalu) warrants that the permanent leads, extensions, anchors, and Implantable Pulse Generators included in the Nalu Neurostimulation System, hereafter referred to as Implantable Components, are free from material defects in workmanship and materials for a period of five (5) years from the date of original purchase from Nalu, unless specifically noted. For clarity, this Limited Warranty with respect to an Implantable Component is not extended if Nalu repairs or replaces such Implantable Component.
If an Implantable Component fails to operate or perform substantially in conformance with Nalu’s published specifications within five years after the original purchase date from Nalu, after Buyer contacts Nalu with respect to such warranty claim, Nalu will at its option repair or replace any Implantable Component(s) so as to cause the same to operate in substantial conformance with said published specification. No other relief whatsoever is available under this Limited Warranty, and this Limited Warranty constitutes Buyer’s entire relief and Nalu’s entire liability with respect to such Implantable Component. Claims under this Limited Warranty are subject to the following additional conditions and limitations:
- The product registration card for such Implantable Component must be completed and returned to Nalu within 30 days of surgery implanting such Implantable Component.
- The Implantable Component must be used before the “use before” date on its label, and in accordance with all written instructions provided by Nalu.
- Failure of the Implantable Component must be confirmed by Nalu, in Nalu’s sole reasonable discretion.
- The Implantable Component must be returned to Nalu (or Nalu’s authorized agent) within 30 days after it fails to operate or perform substantially in conformance with Nalu’s published specifications. That Implantable Component will become Nalu property upon Nalu’s receipt of such Implantable Component.
- This Limited Warranty does not include failures to operate or perform substantially in conformance with Nalu’s published specifications caused by:
(a) fire, floods, lightning, natural disasters, water damage and other calamities commonly defined as “Acts of God”;
(b) accident, misuse, abuse, negligence, or the failure to store, operate, properly handle, or otherwise use the Implantable Component in accordance with manufacturer’s instructions, whether by Buyer, patient, or the healthcare provider that implanted the Implantable Component in patient (“Healthcare Provider”), or other intervening acts by third parties;
(c) unauthorized attempts to repair, maintain, or modify the Implantable Component by the Buyer, patient, Healthcare Provider, or any unauthorized third party; or
(d) body rejection phenomena, change in performance characteristics due to component changes or failures, unusual physiological variations in patient, medical complications; lead/extension dislodgment, lead/extension breakage, or breach of insulation, migration, or erosion of the area around the Implantable Component;
(e) attaching equipment or other accessories to, or using such equipment or other accessories with, the Implantable Component, in each case that are not supplied or expressly authorized by Nalu in writing.
EXCEPT FOR THE LIMITED WARRANTY PROVIDED IN THIS EXHIBIT, NALU MAKES NO WARRANTY WITH RESPECT TO ITS PRODUCTS, EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, WHETHER ARISING FROM STATUTE, COMMON LAW, OR OTHERWISE. THIS LIMITED WARRANTY SHALL BE THE EXCLUSIVE REMEDY AVAILABLE TO ANY PERSON OR ENTITY. NALU IS NOT LIABLE FOR DIRECT OR INDIRECT, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES (INCLUDING BUT NOT LIMITED TO LOSS OF PROFITS OR BUSINESS OR MEDICAL OR HOSPITAL EXPENSES) WHETHER BASED ON CONTRACT, TORT, OR ANY OTHER LEGAL THEORY.
Any legal action arising from the purchase or use of Nalu products shall be commenced within one year from the accrual of the cause of action, or be barred forever. In no event shall Nalu liability under this Limited Warranty or otherwise exceed the purchase price of the product giving rise to the cause of action.
The limitations of liability set forth in this Exhibit apply to all warranty claims. No waiver or amendment of this Limited Warranty shall be valid unless in writing signed by Nalu. Some states, and some countries, do not allow the exclusion or limitation of incidental or consequential damages, so such liability limitations may not apply to the Customer. This Limited Warranty gives the Customer specific legal rights, and he/she may have additional rights which vary from state to state.
Special Notice for Neurostimulation Systems
Nalu Neurostimulation Systems consist of implantable neurostimulators, temporary and permanent leads, extensions, single use accessories, disposable tools, and trial cables.
Neurostimulation Systems once implanted are implanted in the extremely hostile environment of the human body. This environment places severe demands on their design and function.
Consequently, no representation or warranty is made that failure or cessation of function of the Neurostimulation System will not occur, or that the body will not react adversely to their implantation.
The Therapy Discs include a nonseparable power source which will ultimately cease to function due to exhaustion or premature failure, thereby necessitating replacement of the Therapy Disc.
No representation is made that any one Neurostimulation System will last the entire lifetime of any user or for any specific length of time. Inherent uncertainties regarding the longevity of the components make any such assurance impossible.
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