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TERMS AND CONDITIONS OF SALE

 

  1. GENERAL. These Terms and Conditions of Sale (the “Agreement”) are entered into between MED-EL Corporation (“Seller”) and the buyer (the “Buyer”) purchasing products from Seller pursuant to an order placed on the MED-EL website. This Agreement governs the sale of Seller’s products identified in such order (the “Products”) to Buyer.

 

  1. PRICES. All prices exclude sales, use, license excise, and other taxes in respect of manufacture, sale or delivery, export or import duties, all of which shall be paid by Buyer unless a proper exemption certificate is furnished. Prices exclude shipping and handling, which shall be paid by Buyer.

 

  1. TERMS.  Payment is due before shipment, unless otherwise specified or other arrangements have been made in advance, and subject to credit approval. Invoices not paid shall be subject to a service charge of 1-1/4% per month on the past due amount.  Without limiting the above provisions, in the event Buyer does not pay all amounts due and owing within allowed payment terms, Seller may withhold further shipments until acceptable payment is made. Shipment holds shall not constitute Seller’s breach and Seller, in its sole discretion, may continue to perform in accordance to Buyer’s purchase orders. If the purchaser is a device user facility (DUF) and an executed purchasing agreement is currently in place, the terms of that agreement also apply.  These additional Terms and Conditions of Sale apply only if the DUF chooses to use MED-EL’s online system for placing orders.  Where a conflict in terms exists with a separately negotiated purchasing agreement, the negotiated agreement terms control.  For purchase of implant systems, warranty and discount pricing are subject to the surgeon following MED-EL’s prescribed surgical procedure.   

 

  1. ORDER AND ACCEPTANCE. No order is binding on Seller unless accepted by Seller. Seller may reject any order. Any terms proposed by Buyer, which add to, vary from, or conflict with the terms of the Agreement shall be void, and the terms of the Agreement shall govern.

 

  1. DELIVERY AND DELAYS. Unless otherwise specified, delivery will be FOB Seller’s place of origin, and Buyer assumes all responsibility for risk of loss, or damage to, the Products furnished hereunder upon delivery of the Products to the common carrier. Products shall be deemed accepted by Buyer upon Buyer’s receipt thereof. Seller shall have the right to select the means of transportation. Delivery dates quoted by Seller are approximate and subject to confirmation. Delay in delivery by Seller for any shipment shall not relieve Buyer of its obligation to accept remaining installment deliveries.

 

  1. CANCELLATION. Purchase orders cannot be cancelled or rescheduled by Buyer.

 

  1. NO EXPORTS. Buyer agrees that it will not export, directly or indirectly, any Products or information provided hereunder.

 

  1. LIMITED WARRANTIES. Except as set forth below, Seller warrants to Buyer that the Products sold by Seller to Buyer will be free from defects in workmanship and materials under normal use for the periods specified in Seller’s Limited Warranty Schedule, which can be found here.  Upon the return of a defective product, shipping prepaid, by Buyer to Seller at Med-El 2645 Meridian Pkwy, Suite 100, Durham NC, 27713, Seller will, at its sole option, repair or replace the defective product or refund the purchase price.  Any defective product that is repaired is warranted only for the balance of such product’s initial warranty period. Any defective product that is replaced is warranted for the warranty period for such product as specified in Seller’s Limited Warranty Schedule. Any product with an expired or voided warranty that is repaired by Seller is warranted only for such repair, and not the entire product, for a period of ninety (90) days from the date of repair. Notwithstanding the foregoing, Seller does not warrant, and such limited warranty will be null and void, if the product fails to perform or is defective because of accident, casualty, misuse, abuse, fire, alteration, liquid damage, lightening, Act of God or public enemy, vandalism, tampering or because of improper setup, operation, repair, maintenance, testing or unauthorized service.  THIS LIMITED WARRANTY IS MADE IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PURPOSE. 

 

IF THE PRODUCT BUYER IS PURCHASING IS NOT SET FORTH IN SELLER’S LIMITED WARRANTY SCHEDULE, THEN SUCH PRODUCT IS SOLD ON AN “AS-IS” BASIS WITHOUT ANY WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION,  THE IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

 

  1. LIMITATION OF LIABILITY. IN NO EVENT SHALL SELLER OR ITS VENDORS OR ANY OF THEIR RESPECTIVE DIRECTORS, OFFICERS, EMPLOYEES, OR AGENTS, BE LIABLE FOR ANTICIPATED OR ACTUAL LOST PROFITS, FOR DAMAGES ON ACCOUNT OF NEGLIGENCE, OR FOR INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES.  SELLER’S AGGREGATE LIABILITY FOR ANY CLAIM OF ANY KIND, FOR ANY LOSS OR DAMAGE ARISING OUT OF, CONNECTED WITH, OR RESULTING FROM THE SALE OF PRODUCTS TO BUYER.

 

  1. RETURNS AND REFUNDS. All returns of Products and refunds shall be subject to the Seller’s applicable policies and procedures, including its returned goods policies set forth at here.

 

  1. If the pricing offered by Seller to a Buyer constitutes a discount or other reduction in price under Section 1128(b)(3)(a) of the Social Security Act 42 U.S.C. 1320a-7b(b)(3)(a), and C.F.R. ยง 1001.952(h), Buyer shall disclose the discount or reduction in price to the full extent required under any state or federal program that provides cost or charge-based reimbursement to Buyer for products. This act requires, among other things, that Buyer fully and accurately report on any claim or request for payment it submits to Medicare and Medicaid the actual purchase price paid by Buyer for products, net of any discounts, rebates or allowances provided hereunder. Buyer may also be required, upon request, to provide documentation of the discount or other reduction in price to the Secretary of Health and Human Services.

 

  1. If the buyer is a Device User Facility (DUF) and any of the products are medical devices, DUF acknowledges that it is familiar with the Safe Medical Devices Act of 1990 (the “Devices Act”) and the reporting obligations imposed on DUF thereunder. In this regard, DUF agrees to notify Seller within ten (10) days of the occurrence of any event identified in the Devices Act imposing a reporting obligation on Buyer and/or Seller (except for events representing an imminent hazard that require notification to the United States Food and Drug Administration (the “FDA”) within five (5) days, such notice will be delivered to the other party immediately). DUF shall maintain adequate tracking for the products to enable Seller to meet the FDA requirements applicable to the tracking of medical devices.

 

  1. Buyer shall purchase the products for its own use only, and shall not resell the products to any other party, except that licensed medical professionals may purchase Products for distribution to their patients provided that (i) such sales comply with applicable laws, rules and regulations, (ii) Buyer shall maintain adequate tracking for the products to enable Seller to meet the requirements applicable to the tracking of medical devices and (iii) Buyer agrees to report to Seller any complaint regarding a Product of which Buyer becomes aware within 5 working days of receiving the complaint or 2 calendar days if a death or serious injury is involved. Buyer agrees to assist Seller to facilitate the resolution of complaints. For purposes of this Agreement, a complaint can be the occurrence of any of the following: (i) receipt of any Product(s) quality claims, medical claims or complaints or other written claims or complaints; or (ii) receipt of any written communication from any applicable regulatory agency pertaining to a Product.

 

  1. CHOICE OF LAW. This Agreement shall be governed by and construed and enforced in accordance with the laws of the State of North Carolina, excluding that body of law known as choice of law, and shall be binding upon the parties hereto in the United States and worldwide. All disputes with respect to this Agreement shall be brought and heard either in the state and federal courts located in Raleigh, North Carolina. The parties to this Agreement each consent to the in personam jurisdiction and venue of such courts.

 

  1. GENERAL. The failure of Seller to insist, in any one or more instances, upon the performance of any of the terms, covenants or conditions of this contract or to exercise any right hereunder shall not be construed as a waiver or relinquishment of the future performance of any such term, covenant or condition or the future exercise of such rights. This Agreement and any acknowledgement or acceptance of a purchase order by Seller constitute the complete and exclusive statement of the agreement between the parties regarding the subject matter hereof and supersede all proposals, oral or written, and all other communications between the parties relating to the subject matter herein.  Notwithstanding the foregoing, if Buyer is a party to a purchasing agreement with Seller at the time it submits an order covering the purchase and sale of the Product ordered by Buyer, such purchasing agreement shall apply to such order and this Agreement shall have no effect with respect thereto.

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