Accufix Surgical® Terms and Conditions

Accufix Surgical, Inc. Terms and Conditions of Product Sale to Customer

1. Application. The following terms and conditions (“Terms”) are part of the written order (“Order”) between the customer named in the Order (“Customer”) and Accufix Holdings, Inc. (“Accufix”) for the purchase of Accufix’s products (“Products”), either directly from Accufix or from Accufix’s authorized distributor or reseller (“Distributor”). Accufix’s acceptance of any Order by Customer is expressly conditioned on Customer’s agreement to these Terms.

2. Entire Agreement. These terms and the Order constitute the entire binding agreement (“Agreement”) by and between Customer and Accufix Holdings, Inc. relating to Customer’s purchase of Accufix products (the “Products”). This Agreement supersedes all other agreements and understandings, whether written or oral, between the parties relating to Customer’s purchase of the Products. Notwithstanding anything to the contrary, whether executing a purchase order, quotation, or proposal, or by accepting delivery of the Products, Customer agrees to be bound by and accept the terms of this Agreement. No conditions, amendments, or modifications by Customer or any other person, whether oral or contained in any other documents submitted from Customer to Accufix, will be binding on Accufix, regardless of Accufix’s failure to object or Accufix’s shipment of Products, unless otherwise agreed to in writing and signed by Accufix. For avoidance of doubt, Distributor does not have authority to modify these Terms without Accufix’s express written approval. These Terms will take precedence over any conflicting terms in the Order except to the extent the Order expressly refers to specific provisions of these Terms and states the intent of Accufix and Customer to supersede those specific provisions.

3. Pricing and Payment Terms. (a) Except as expressly specified in the Order, the price for Products purchased by Customer will be based on the latest list price published by Accufix. The latest published price list supersedes all previous price lists.

(b) Prices are subject to applicable tax. Organizations exempt from taxes or that resell product must provide Accufix with a valid exemption or resale certificate for each applicable jurisdiction. Pricing includes freight charges, or storage fees.

(c) Unless otherwise specified in the Order, Accufix will invoice Customer for Products immediately following use, and payment by Customer is due net thirty (30) days from date of invoice. Payments must be sent to the address on Accufix’s invoice or via ACH per banking instruction on file with the Customer. Accufix reserves the right to terminate or limit open account credit at any time. Any discrepancy between an invoiced price and the corresponding order price must be reported to Accufix’s customer service team within thirty (30) days of the date of invoice. Customer’s failure to make timely payment is a material breach for which (in addition to other available remedies) Accufix may suspend performance under any or all Accufix agreements until all past due amounts are brought current. Interest shall accrue on past-due amounts at a rate equal to the lesser of 1.5% per month or the maximum rate permitted by applicable law. Customer shall reimburse Accufix for reasonable costs (including attorneys’ fees) relating to collection of past due amounts. Any credits due to Customer under an agreement may be applied first to any outstanding balance.

4. Inspection and Acceptance. (a) Customer must inspect delivered Products and report claims for defects, damages, shortages, or receipt of wrong Products which are discoverable on a visual inspection within 72 hours of delivery. Upon receiving such report, Accufix will provide instructions for return of the Product. If after their return Accufix confirms the report, Customer will not be charged for the Products.

(b) Except as provided in paragraph (a), delivered Products are deemed irrevocably accepted and may not be returned, and such claims will be deemed waived. No acts on the part of Accufix, including, but not limited to, Accufix’s receipt of returned Products, shall constitute Accufix’s approval or acceptance of the returned Products.

5. Use of Products. Products may be used only in accordance with the instructions for their use published by Accufix, the FDA-specified Indications for Use, and any additional specification attached to or referred to in the Order (the “Specifications”), and only by licensed, qualified surgeons who have completed training in their use. The surgeon may request that a trained representative from Accufix or Distributor be made available to be present before or during any procedure using the Products to provide information about the proper use of the device and technical assistance. Customer represents that Customer is properly licensed and authorized to use the Products.

6. No Resale or Transfer; Intellectual Property. The Products may not be resold or transferred to any third party by Customer without the prior written authorization of Accufix. Customer acknowledges and agrees that the Products are covered by valuable intellectual property owned by or licensed to Accufix. Neither this Agreement nor Customer’s purchase of Product shall be construed as a grant of any other rights in or to the intellectual property covering the Products. Customer’s unauthorized resale or counterfeiting of Product(s) would cause immediate, material, and irreparable harm to Accufix.

7. Limited Warranty. (a) Accufix warrants to Customer that all Products purchased will conform in all material respects to the Specifications in effect at the time of shipment of the Products and will be free from defects in workmanship and material at the time of shipment. The limited warranty stated in this Section 7 applies only to the original purchaser from Accufix and is not transferable, and does not extend to or cover and of the following:

any product, components, or parts not manufactured or sold by Accufix;
a Product that Customer obtains from a person or entity other than Accufix or the Distributor;

iii. any use of the Product that is prohibited under or inconsistent with these Terms;

any other abuse or misuse by Customer, its employees, representatives, contractors and agents;
damage caused by use of the Product for purposes other than those for which it was designed as indicated in Accufix’s Specifications;
any Product that has been modified without Accufix’s authorization, or damage caused by any unauthorized attachments or modification;

(b) The provisions of paragraph 4(a) above apply in the case of a Product defect that is discoverable on a visual inspection. In the case of a failure of a Product to conform to Specifications or a defect in material and workmanship that is not discoverable on a visual inspection, Customer must promptly notify Accufix and the Distributor in writing. Within a reasonable time after such notification, Accufix will within a reasonable time after the notification correct any failure of the Product to conform to the warranty by providing, at Accufix’s option, repair of the Product, a replacement unit, or a refund or credit in the amount of the purchase price paid by Customer. Customer’s sole remedy for breach of any product warranty shall be the repair, replacement or refund by Accufix as provided in this paragraph 7(b).

(c) EXCEPT AS EXPRESSLY SET FORTH HEREIN, THE PRODUCTS ARE PROVIDED TO CUSTOMER “AS IS”, WITHOUT ANY WARRANTIES OF ANY KIND. ACCUFIX EXPRESSLY DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NONINFRINGEMENT OF INTELLECTUAL PROPERTY RIGHTS. ACCUFIX SHALL HAVE NO LIABILITY TO CUSTOMER, ITS AFFILIATES, OR ITS END CUSTOMERS, OR TO ANY OTHER THIRD PARTY, FOR ANY DAMAGES, INCLUDING DAMAGES RESULTING OR ALLEGED TO RESULT FROM ANY DEFECT, ERROR, OR OMISSION IN THE PRODUCTS, OR AS A RESULT OF ANY INFRINGEMENT OF ANY INTELLECTUAL PROPERTY RIGHT OF ANY THIRD PARTY. UNDER NO CIRCUMSTANCES WILL ACCUFIX HAVE ANY LIABILITY TO CUSTOMER FOR, AND CUSTOMER HEREBY EXPRESSLY WAIVES, ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, OR PUNITIVE DAMAGES OF ANY DESCRIPTION, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, WHETHER ARISING OUT OF WARRANTY OR CONTRACT, NEGLIGENCE OR OTHER TORT, OR OTHERWISE, INCLUDING, WITHOUT LIMITATION, FORESEEABLE BUSINESS LOSSES, LOSS OF PROFITS, AND RELIANCE DAMAGES. CUSTOMER AGREES THAT UNDER NO CIRCUMSTANCES WILL ACCUFIX’S LIABILITY UNDER THIS AGREEMENT FOR ANY CAUSE EXCEED THE PURCHASE PRICE PAID BY CUSTOMER FOR THE PARTICULAR PRODUCT(S) INVOLVED. NOTWITHSTANDING ANYTHING IN THIS AGREEMENT TO THE CONTRARY, THE REMEDIES SET FORTH IN THIS AGREEMENT WILL APPLY EVEN IF SUCH REMEDIES FAIL THEIR ESSENTIAL PURPOSE.

8. Essential Basis of the Bargain. Customer acknowledges that Accufix has set its Product prices and entered into the Agreement in reliance upon the limitations of liability and the disclaimers of warranties set forth herein, that the same form an essential basis of the bargain between the parties, and THAT THE CONSIDERATION WOULD BE HIGHER IF ACCUFIX WERE REQUIRED TO BEAR LIABILITY IN EXCESS OF THAT STATED HEREIN.

9. Regulatory Matters. Customer shall immediately forward to Accufix information concerning all actual or threatened charges, complaints or claims of any nature, which relate in any way to the Products and which come to Customer’s attention. Customer shall cooperate with Accufix, its representatives (including regulatory), its legal counsel, its insurance carriers and their legal counsel in investigating and defending any such charges, complaints or claims. Customer and its employees shall, at Accufix’s request, provide Accufix with reasonable assistance in gathering information concerning such charges, complaints or claims and in giving oral or written testimony as to all facts in their possession concerning such charges, complaints or claims.

10. Compliance with Applicable Laws. Accufix and Customer agree that each of them will conduct its business and affairs in an ethical manner and comply with all applicable laws and regulations, including but not limited to the Anti-Kickback Statute, the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations, and the Medical Device Reporting regulation. Without limiting the generality of the foregoing, Accufix and Customer each represents and warrants that it has not made or offered, is not obligated to make, and will not make or offer any payment or remuneration to any third party in return for Customer purchasing the Products or for any business transacted between Accufix, Customer, or the Distributor.

11. Records & Disclosure of Discounts. If Customer informs Accufix that Customer is an institution required to file Medicare/Medicaid cost reports with federal or state agencies for payment, Customer acknowledges that Customer has an obligation under federal law to fully and accurately report all discounts received in its cost reports. (Public Law 100-93, the “Medicare and Medicaid Patient and Program Protection Act of 1987”; 42 CFR part 1001), and Accufix will provide Customer with invoices or other documents that fully and accurately disclose the discounted price of all Products purchased under the Purchase Agreement.

12. Non-Exclusion. Accufix and Customer each represents and warrants to the other that it and its officers, directors and employees (i) are not currently excluded, debarred, or otherwise ineligible to participate in the federal health care programs as defined in 42 U.S.C. §1320a-7b(f) (the “Federal Healthcare Programs”) and (ii) have not been convicted of a criminal offense related to the provision of healthcare items or services which could result in becoming been excluded, debarred, or otherwise declared ineligible to participate in the Federal Healthcare Programs. Each party shall immediately notify the other party of any change in the status of the representations and warranty set forth in this Section.

13. Assignment. Accufix may assign all or any part of its rights and obligations under these Terms without the need for Customer’s consent to any affiliate of Accufix or, in the event of a merger, acquisition, change of control, reorganization or sale of substantially all of Accufix’s assets, to Accufix’s successor.

14. Governing Law and Venue; Class Action Waiver: This Agreement and all disputes and matters relating hereto shall be construed in accordance with the laws of the State of Connecticut without giving effect to its conflicts of laws rules. Customer hereby consents to the jurisdiction and venue of any New Haven County, Connecticut state or federal courts, and hereby waives any objections based on inconvenient forum or conflicts of laws principles. Where permitted under the applicable law, Customer and Accufix each waives the right to litigate any dispute as class action, either as a member of a class or as a representative, or to actas a private attorney general. Unless Customer and Accufix both agree, no action, or court of law, may consolidate more than one person’s claims or otherwise preside over any form of a representative or class proceeding. Notwithstanding the foregoing, if the foregoing class action waiver or any other provision of this Agreement shall be determined to be illegal or unenforceable by any court of law in any jurisdiction, the remaining provisions hereof and thereof shall be severable and enforceable in accordance with their terms, and all provisions shall remain enforceable in any other jurisdiction.