Terms & Conditions

---

I. GENERAL

A. Delivery, Inspection and Acceptance.

1. Terms are FOB Shipping Point: Buyer will take ownership upon shipment of product from Seller. All shipping costs shall be born by buyer and terms of delivery shall be stated on the purchase order supplied along with the Buyers shipping account information. 

2. Products Not Requiring Installation by Supplier. Regardless of Supplier’s Return Policy, for any Product that Supplier does not install, a Customer has 15 days from the date of delivery to inspect and accept or reject the Product. If the Customer finds the Product is broken or damaged, then the Customer may reject the Product and return it at Supplier’s expense.

B. Product Recalls. In addition to any notification required by law, within 24 hours after Supplier first learns of a recall, Supplier agrees to notify the Customer that received or ordered a recalled Product. Supplier must use its reasonable commercial efforts to monitor the recall status of affected Products. Each recall notice must include specific information related to the recall as well as the suggested action to be taken by the Customer. Supplier must reimburse each Customer for its costs associated with the correction of a recall and actions taken in response to a recall.

C. Product Notices. Supplier must send all notices relating to a Product, as well as notices of any other changes affecting a Product and notices of new Products, to the Customer. Supplier must send written notices to each Customer not more than 24 hours after Supplier learns of any Product notice that may adversely affect the health or well-being of any user of the Product. Supplier must notify each Customer of any defects, errors, non-conformity with the warranties under this Agreement, or other problems with any Product or services, promptly after the problems first become known to Supplier.

D. HCPCS Codes for Medicare Reporting. Supplier must provide to Customers all HCPCS Codes recognized by Medicare for all Products and must cross-reference each HCPCS Code by Supplier’s name, Supplier’s identification number, and Supplier’s product catalog number.

E. Quality Assurance. Upon any Customer’s request, and at no additional cost, Supplier must provide (i) access to its facilities for one of Customer’s Representatives, and (ii) Product information sufficient for the Customer to evaluate Supplier’s manufacturing processes for the purpose of assessing Product quality assurance.

F. Demonstration Samples. Non-sterile demonstration samples of Products may from time to time, on a case-by-case basis, be available. All demo samples are not for human use. 

II. FIRMWARE LICENSE

1. “Firmware” includes all the programming code or instructions stored in read-only memory or on a hardware device incorporated into the Product. Firmware also includes any associated documentation supplied for use in connection with the Product.

2. Firmware License Grant. With the delivery of, and with respect to, any Product containing Firmware, Supplier must provide each Customer with a non-exclusive, worldwide, perpetual, and irrevocable license to load, run, transfer, and use the Firmware (“Firmware License”).

3. General. Supplier must not provide any Firmware to any Customer: (a) in violation of any applicable law, statute, ordinance, or regulation; (b) that will infringe upon the intellectual property rights of any third party; or (c) that contains any asset protection devices or similar time-out mechanisms.

4. Malware Protection. Supplier must test all Firmware prior to shipment for known computer viruses in accordance with medical device industry standards, including the use of third party anti-virus detection software. Supplier must not provide any Firmware to any Customer that contains viruses, Trojan horses, worms, time bombs, malicious code, or other computer programming routines that are intended to destroy, detrimentally interfere with, intercept, or expropriate any of the Customer’s systems, data, or personal information.

III. SUPPLIER’S RETURN POLICY

A. Reasons for Returns. Any Customer may return a Product to Supplier for 100% credit within 90 days, if the Customer determines in good faith that any of the following conditions are met:

1. Supplier shipped the Product in error;

2. Product is damaged before it is accepted by the Customer;

3. Product packaging or crating is damaged before it is accepted by the Customer;

4. Product does not meet industry quality standards related to performance specifications and data submissions required by the FDA or FDA approval of the Product; or

5. Product is outdated or expired when delivered to the Customer; 

B. Manner of Return. Where possible, a Customer must return a Product in its original packaging or crating.

C. Restocking Fees. If returned within 30 days, Supplier must not charge any restocking fee and Supplier must pay all return shipping costs unless the Customer ordered the Product in error. If product is returned after 30 days, a 15% restocking fee will be imposed on the credit. 

IV:  SUPPLIER’S PRODUCT WARRANTIES

This product warranty document applies to products listed on Exhibit A. This warranty does not apply to replacement parts. 

A. INTEGRATED HARDWARE/SOFTWARE PRODUCTS LIMITED WARRANTY

1. Commencement of Warranty Period. For all Products the warranty period begins on acceptance of the Product by Customer.

2. “Product Specifications” means specific technical information about Products, which is published in product manuals and technical data sheets in effect on the date Supplier ships Customer’s order.

Integrated Hardware/Software Products are those which run on designated hardware platforms and which contain hardware which is part of the Product as described in the Product’s Specifications. Supplier warrants such Products against defects in materials and workmanship and will perform substantially within the Product’s Specifications for a period of 36 months. Supplier does not warrant that operation of the Product will be error-free or uninterrupted. If the Product is found to be defective during the warranty period, the part(s) and labor required to repair the Product will be provided by Supplier free of charge.

B. IMPLANTED PRODUCTS LIMITED WARRANTY. Subject to the conditions and limitations set forth below, Supplier warrants that its Products will be free from defects in material or workmanship while in place in the patient in whom it is originally implanted. Supplier will furnish, without charge, a replacement for any Product that it determines to have failed to function within normal tolerances because of a defect in materials or workmanship. The responsibility of Supplier under this Limited Warranty is specifically conditioned upon each of the following conditions being met: 

1. The Product must have been implanted prior to the “USE BEFORE” date marked on the package; 
2. Supplier must receive an original registration at the time of implant in order to validate Limited Warranty; 
3. The Product has not been damaged or altered by improper handling, use, or placement (with proper instructions on handling, use and placement provided by Supplier); 
4. The explanted Product must be returned to Supplier within 30 days after removal from the patient. In the event that the device removal is impractical, Supplier will accept data accompanied by alternative objective evidence of failure, such as x-ray imagery; 
5. The replacement Product shall be manufactured by Supplier; 
6. All claims must be submitted in writing with required data to the Supplier.

C. DISCLAIMER. THIS LIMITED WARRANTY IS IN LIEU OF ANY OTHER WARRANTY EXPRESSED OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE, WHICH ARE SPECIFICALLY DISCLAIMED. No representation or warranty is made that a Supplier product will not fail. No person has the authority to bind Supplier to any representation or warranty in connection with the sale or use of its Products. 

D. GENERAL WARNING. Supplier’s implantable Products are implanted in an extremely hostile environment of the human body. Products are necessarily very small in diameter and must be very flexible, which unavoidably reduces their potential performance or longevity. Products may fail to function for a variety of causes, including but not limited to medical complications, body rejection phenomenon, allergic reaction, fibroid tissue, failure of device by breakage, fracture, breach of manufacture, and testing prior to sale. Products may be damaged before, during, or after insertion by improper handling, placement, or by other intervening acts. Consequently, no representation is made that insertion by improper handling or cessation of function of the Product will not occur or that the body will not react adversely to the implantation of devices or that medical complications will not follow the implantation of Products. Supplier will provide to each Customer instructions for proper handling, placement, and use of each Product.