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North American Terms and Conditions of Sale


(Orders originating and shipping from North America)

1. Intent

These are the terms and conditions of sale (the “Terms”) for products and related materials (collectively, the “Products”). These Terms supplement written consistent terms and conditions provided with the Purchase Order for the Product (“PO”), and expressly supersede any terms and conditions of the PO or any other document that are in any way inconsistent with these Terms. Seller hereby gives notice of its objection to any terms or conditions in the PO which are inconsistent with these Terms. These Terms and the PO, as supplemented and superseded by these Terms, are collectively referred to as the “Agreement.” “Seller” means Cook Medical LLC. “Buyer” means a customer of Seller who intends to purchase the Products. Products are not intended for resale. These Terms set forth the only terms and conditions under which Seller will sell Products to Buyer notwithstanding any conflicting term or condition contained in the PO, request for proposals, purchase agreements, or any other form submitted by Buyer (collectively “Order“). If, however, a written contract signed by an authorized signatory of Seller (in each case, an officer of Seller) is already in existence between Buyer and Seller covering the purchase of Products, the terms of such contract shall prevail to the extent that it is inconsistent with these terms.

2. Inspection by Buyer; Rejection of Nonconforming Products

Products are subject to Buyer’s reasonable inspection at Buyer’s destination. Buyer shall inspect Products at the time of delivery and shall be deemed to have accepted the Products unless written notice of objection is received by Seller within twenty (20) business days after the date of delivery. In the event the Buyer, after such inspection, rejects Products because they fail to conform to the manufacturer’s specifications, Buyer shall have the right to return nonconforming Products for credit or replacement at Seller’s sole option. Any claim(s) arising from any alleged breach of warranties in Section 5, or any alleged shortages, or any failure in shipment or delivery are waived and released by Buyer unless notice of such claims is made in writing and received by Seller within twenty (20) business days from the date of delivery. All claims must set forth in detail the alleged nonconformance that is the basis for rejection. The absence of such written notice received by seller within twenty (20) business days shall constitute acceptance of the Products and no claim for rejection shall be effective. Prior authorization for all returned Products is required. To obtain a “Return Authorization Number,” Buyer must contact Seller’s Customer Support department at 1-800-457-4500. Packages returned to Seller should be marked with the Return Authorization Number on the outside of the package and shipped to Seller to the attention of the Returned Goods department.

3. Return of Stock Product

Seller will accept return of stock Products that conform to manufacturer’s specifications within ninety (90) calendar days from invoice date of that Product’s original shipment. Seller will not accept return of any special order, custom, or other non-stock Products. Prior authorization for all returned Products is required. To obtain a “Return Authorization Number,” Buyer must contact Seller’s Customer Support department at 1-800-457-4500. Packages returned to Seller should be marked with the Return Authorization Number on the outside of the outer shipping packaging and shipped to Seller to the attention of the Returned Goods department. Any request for return of stock Products must specify the reason for return, the original order number, quantity, lot number, and invoice number with date of invoice. All authorized returned Products must be returned to Seller in their original, unopened packages, undamaged and unmarked, packed appropriately for shipping, and not have been used or re-sterilized. Products must be in saleable condition and suitable for restocking. Buyer acknowledges that Products have varying shelf-lives and that certain restrictions and/or restocking charges may apply based on the remaining shelf-life of the returned Product. Returned Products are subject to a twenty (20%) percent reprocessing charge.

4. Treatment of Ordering Errors

In the event of a processing or ordering error caused by Buyer that is reported to and received by Seller within twenty (20) business days of the date of delivery to Buyer, Buyer may return to Seller the excess stock Products received which will be subject to a reprocessing charge of up to twenty (20%) percent of the original price of Products at Seller’s sole discretion, and Buyer is responsible for shipping costs for Order returns related to ordering errors caused by Buyer. Seller will not accept return of any special order, custom, or other non-stock Products. In the event of a processing or ordering error caused by Seller that is reported to Seller within twenty (20) business days of the date of delivery to Buyer, Buyer may return to Seller the excess Products received and such returned Product will not be subject to a reprocessing charge and Buyer is not responsible for shipping costs for Order returns related to ordering errors caused by Seller. No credit will be given for Products returned in a condition unsuitable for restocking. Prior authorization for all returned Products is required. To obtain a “Return Authorization Number,” Buyer must contact Seller’s Customer Support department at 1-800-457-4500. Packages returned to Seller should be marked with the Return Authorization Number on the outside of the outer packaging and shipped to Seller to the attention of the Returned Goods Department.

5. Limited Non-Transferable Warranty

This limited warranty applies solely to Products purchased by Buyer directly from Seller or Seller’s authorized distributor. Seller warrants only that, at the time of manufacture, Products (i) are manufactured in accordance with good manufacturing practices, as required by the United States Food and Drug Administration; (ii) conform to manufacturer’s specifications; (iii) are free from defects in materials and workmanship; and (iv) are not adulterated or misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act as amended. Seller also warrants that it has clear title to Products and that Products shall be delivered free of liens and encumbrances. THE FOREGOING WARRANTIES ARE EXCLUSIVE AND IN LIEU OF AND SHALL SUPERSEDE ALL OTHER WARRANTIES OF ANY KIND, WHETHER WRITTEN, ORAL. EXPRESS, OR IMPLIED. THERE ARE NO WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. PRODUCTS ARE NOT INTENDED FOR RESALE AND ANY RESALE OF PRODUCTS BY BUYER VOIDS ALL PRODUCT WARRANTIES, BOTH EXPRESS AND IMPLIED. No representative of Seller may change any of the foregoing and Buyer accepts Products subject to all terms hereof. Buyer acknowledges that the Products are medical devices that have risks, including those described in the Instruction for Use for the Products. Accordingly, Seller expressly makes no warranties that the Products will be safe and effective when used, including in each application, in each patient or under any and all circumstances.

6. Limitation of Remedies and Damages

Buyer’s sole and exclusive remedy for any claim arising by reason of or in connection with the sale, purchase, delivery, or use of Products, regardless of whether such claim is based on tort law, breach of contract, breach of warranty, or any other legal theory (“Claim”) shall be the repair or replacement of any nonconforming Products at Seller’s sole option. UNDER NO CIRCUMSTANCES SHALL SELLER BE LIABLE FOR LOSS OF USE, LOST PROFITS, OR ANY OTHER COLLATERAL, SPECIAL, CONSEQUENTIAL, OR OTHER DAMAGES, LOSSES, OR EXPENSES IN CONNECTION WITH OR BY REASON OF ANY CLAIM OR BREACH, WHETHER SUCH CLAIM OR BREACH IS FOUNDED IN TORT OR CONTRACT. The foregoing constitutes the sole and exclusive remedies of Buyer and the exclusive liability of Seller. Any lawsuit asserting any Claim arising out of the Agreement, including these Terms, must be brought within one (1) year and one (1) day after delivery of the alleged nonconforming Product to Buyer or such Claim shall be forever barred.

7. Insurance

During the term of the Agreement, and for at least five (5) years thereafter, Buyer shall obtain and maintain commercial general liability insurance in full force and effect, at its own expense and sufficient to cover claims relating to the Agreement.

8. Discounts

Buyer and Seller each acknowledge that it is their intent to establish a business relationship in which any rebates, discounts, payments, and credits provided to Buyer by Seller (“Discounts”) comply with the exceptions to the U.S. Anti-Kickback Statute set forth at 42 U.S.C. 1320a-7b(b)(3) and the “Safe Harbor” regulations regarding discounts set forth in 42 C.F.R. 1001.952(b); and the parties believe that the relationship contemplated by this Agreement is in compliance with those requirements. Buyer agrees to report all Discounts to its payors in accordance with the requirements of the Anti-Kickback Statute and any other applicable laws or regulations.

9. Price

The amounts invoiced to Buyer by Seller are inclusive of any applicable discounts, pricing concessions, and related costs of manufacture and supply of the Products as described herein (the “Price”); however, no discount is valid if the resulting Price of any Product would be below Seller’s cost to manufacture the Product. The formula for calculating any applicable rebate which is redeemable at a later time must be fixed, described in detail, and disclosed in writing prior to the purchase; additionally, any failure to so do necessarily voids any such rebate. Pursuant to Section 9 of this Agreement, Buyer is responsible for any applicable reporting requirements related to Price and/or discount(s). Buyer shall be responsible for all charges for taxes related to or calculated from the Price. Sales and use taxes, not subject to exemption, shall be stated separately in Seller’s invoice. Except as specifically set forth on Seller’s bid or firm offer, Price is subject to change without notice and any Order calling for future delivery shall be billed according to the Price in effect at the time of Order. It is Buyer’s responsibility to provide proof of tax-exempt status if applicable.

10. Payment Terms

Full payment without setoff shall be due to Seller from Buyer within thirty (30) calendar days following delivery of Product(s) to Buyer unless otherwise agreed to in writing. If Buyer wishes to pay an invoice by credit or other non-debit-type payment card(s), a surcharge of 2.6% will be added to the invoice value of such card-payments received, unless prohibited by law. Such surcharge will be applied when card-payments are made (i.e., when paying invoices on or by their due date, or at time of order for pre-paid orders). Buyer shall pay to Seller interest on all amounts past due at the lesser of (i) one and one-half percent (1.50%) per month or (ii) the maximum interest rate legally permitted, until payment in full has been made. Buyer shall pay Seller for all Products that are delivered as to which there is no dispute regardless of whether a dispute exists as to any other obligation between Buyer and Seller. In the event that Seller files a lawsuit in order to collect any payment due from Buyer, Seller shall be entitled to recover, in addition to its actual damages, the costs and expenses of recovery, including reasonable attorneys’ fees, costs, and expenses.

11. Shipping Terms

Unless otherwise agreed in writing, all Products shipped by Seller are delivered: (i) FCA (Incoterms 2020) Seller’s facility for shipments delivered to destinations outside the United States and Canada with title and risk of loss passing to Buyer upon placement of Product with Buyer’s designated shipper; and (ii) DDP (Incoterms 2020) Buyer’s specified destination for shipments delivered to destinations within the United States and Canada with title and risk of loss passing to Buyer upon receipt by Buyer at Buyer’s location. Identification of the Products provided pursuant to this Agreement shall occur when the Product is placed in the hands of the carrier. Seller reserves the right to select reasonable method of shipping, routing, and carrier for all Orders. Default shipping for all Orders of stock Products is included in the Price of the Products ordered, with standard service delivery of two (2) business days. Non-stock or other Products not in inventory will be shipped upon manufacture or when Product becomes available and with the shipping cost for these Orders included in the Price of the Products ordered. The cost of all special shipping requests for service delivery in fewer than two (2) business days (e.g., next-day shipping of stock Products) is not included in the Price of Products ordered and shall incur a surcharge applied to Buyer’s invoice. Buyer agrees that any orders placed for a single daily address will be combined to minimize boxes; if Buyer provides written confirmation to Seller that Buyer does not want to combine orders, such order will be deemed a special order and Buyer will be responsible for freight costs.

For each Order Seller accepts, Seller shall acknowledge and confirm each Order’s delivery dates. Buyer agrees that Seller shall not be responsible for any delays, cancellations, or shortages arising, directly or indirectly, from acts of God or the public enemy, governmental restrictions, decrees or orders, floods, fire, collapse, delay or defaults of common carriers, failure or curtailment of Seller’s usual source of supply, earthquakes, explosion, epidemic, war, invasions, terrorist acts, civil unrest, riots, strike, labor difficulties, embargoes, or, without limiting the foregoing, any other delay beyond Seller’s reasonable control; provided, however, that Seller shall use reasonable efforts to notify Buyer of anticipated delays and to fill such orders as soon as reasonably practicable. If any order for stock Products is not shipped within thirty (30) calendar days from the date Seller received such order, or Seller notifies Buyer that any order will not be shipped within thirty (30) calendar days from the date Seller received such order, then upon written notice to Seller prior to shipment of any delayed order, Buyer may cancel such order in whole or in part.

12. Export Control

Diversion, resale, or re-export of these products to individuals, entities or destinations that are subject to United States sanctions programs, embargoes, or other export control programs without an appropriate export license is prohibited.

13. Product Instruction, Education, Training & Support

With respect to certain of the Products, Seller will make available instruction, education, training, and support related to their use. Contact Seller for details.

14. Release of Information

In the event either Buyer or Seller must access, transfer, process, store, and maintain personal data of Buyer or Seller employees or other real persons, both Buyer and Seller shall access, transfer, process, store, and maintain such personal data in accordance with applicable privacy laws and regulations, as may be amended from time to time.

If Buyer or Seller becomes aware of either (a) any unlawful access to any Buyer or Seller Data stored on Buyer or Seller’s equipment or in Buyer or Seller facilities; or (b) any unauthorized access to such equipment or facilities, where in either case such access results in loss, disclosure, or alteration of Buyer or Seller Data and compromises the security or confidentiality of such Buyer or Seller Data (each a “Security Incident”), Buyer or Seller will promptly: (a) notify Buyer or Seller of the Security Incident; and (b) take reasonable steps to mitigate the effects and to minimize any damage resulting from the Security Incident. For purposes of this Section, “Buyer or Seller Data” shall include any Buyer or Seller confidential or sensitive information that would result in a high or moderate risk of financial loss, harm or legal liability if such information is disclosed without authorization.

15. Miscellaneous

a) Waiver. No waiver by any party of any breach on the part of the other party will be a waiver of any subsequent breach.

b) Independent Contractor. Each party is an independent contractor and not the agent, partner, or employee of the other party.

c) No Third-Party Rights. Nothing in this Agreement shall be construed as creating or giving rise to any rights in third parties or persons other than the named parties to this Agreement.

d) Governing Law and Venue. This Agreement and these Terms are being delivered and executed in the State of Indiana. Any action brought regarding the validity, construction, performance, breach, termination, or enforcement of this Agreement or these Terms shall be governed in all respects by the internal laws of the State of Indiana, without regard to the principles of conflicts of laws and shall in no way be subject to the United Nations Convention on Contracts for the International Sale of Goods. Jurisdiction and Venue for any action or proceeding brought regarding the validity, construction, performance, breach, termination, or enforcement of this Agreement or these Terms shall be exclusively the federal courts of the Southern District of Indiana, and the parties expressly agree and consent to the personal jurisdiction of the federal courts of the Southern District of Indiana, and further consent to service of process issued by such Court.

Revised: 28 September 2023