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TERMS AND CONDITIONS

Fiagon NA, LLC. Standard Terms and Conditions of Sale

ALL SALES MADE BY FIAGON NA, LLC. (“SELLER”) TO THE BUYER (“BUYER”) ARE EXPRESSLY CONDITIONED ON BUYER’S ACCEPTANCE OF THE FOLLOWING TERMS AND CONDITIONS. THESE TERMS AND CONDITIONS CONSTITUTE THE ENTIRE AGREEMENT BETWEEN SELLER AND BUYER AND SUPERSEDE ALL PREVIOUS NEGOTIATIONS, DISCUSSIONS AND UNDERSTANDINGS, WHETHER ORAL OR WRITTEN, BETWEEN THE PARTIES WITH RESPECT TO THE SUBJECT MATTER HEREOF. SELLER WILL NOT BE BOUND BY ANY TERMS OF BUYER’S PURCHASE ORDER OR OTHER DOCUMENT THAT ARE ADDITIONAL OR INCONSISTENT WITH THE TERMS HEREIN INCLUDING ANY PROVISION INCORPORATING WHAT IS COMMONLY CALLED A “MOST FAVORED NATION” OR “MOST FAVORED PRICING” TERM AND ALL SUCH TERMS SHALL BE EXCLUDED. THESE TERMS MAY ONLY BE AMENDED OR WAIVED BY A WRITING SIGNED BY AN AUTHORIZED REPRESENTATIVE OF SELLER.

1. Terms and Conditions of Supply of Products.

1.1 Terms and Conditions. All purchase order acceptances shall be conditioned upon Buyer’s unqualified acceptance of the terms and conditions set forth herein, which may be made by written acceptance or by receipt by Buyer of delivery of any products.

1.2 Order and Acceptance. All orders for products shall be made by written purchase order. All purchase orders will be governed by these terms and conditions; if any terms and conditions set forth in a purchase order are in conflict with these terms of and conditions, then these terms and conditions will govern. No order shall be binding upon Seller until accepted by Seller in writing, and Seller shall have no liability to Buyer with respect to purchase orders that are not accepted. Buyer shall submit purchase orders to Seller in accordance with Seller’s then current lead times.

1.3 Delivery, Shipping, Risk of Loss. Seller will use reasonable efforts to deliver products at the times specified in Seller’s acceptance of Buyer’s purchase order; provided, however, that all delivery dates are estimates only and deliveries may be in installments. All products delivered hereunder will be suitably packed for shipment in Seller’s standard containers, marked for shipment to Buyer’s address specified in Buyer’s purchase order, and shipped F.O.B. Seller’s manufacturing facility (“Shipping Point”), at which time risk of loss from any casualty and title pass to Buyer. All freight, insurance and other shipping expenses from the Shipping Point will be borne by Buyer. If Seller fails to deliver an order to Buyer within a reasonable period of time following the delivery date furnished to Buyer in Seller’s acceptance of Buyer’s purchase order, Seller’s sole liability and Buyer’s sole remedy will be to cancel the delayed order free of charge.

1.4 Acceptance of products. Buyer shall have the obligation to inspect and the right to reject products within fifteen (15) days after receipt thereof exclusively for failure to substantially conform to Seller’s published specifications. If Buyer fails to notify Seller in writing of its rejection and reasons therefor within such period, Buyer will be conclusively deemed to have irrevocably accepted the products, except as set forth in Section 6 below. Buyer’s sole remedy is limited to Section 6.2 below. Buyer shall have no right to return products that conform to Seller’s published specifications.

2. Price and Payment.

2.1 Price. Prices for products shall be Seller’s standard list price unless otherwise designated by Seller (“Purchase Price“). Seller has the right to revise Purchase Prices upon advance written notice to Buyer. Price increases will apply to all purchase orders received after the effective date of the price revision.

2.2 Payment Terms. Payment terms shall be net thirty (30) days after the date of Seller’s invoice. Buyer will make payments in United States dollars by check or wire transfer to an account designated by Seller. Any invoiced amount not paid when due shall be subject to a service charge equal to the lesser of one and one-half percent (1.5%) per month or the maximum rate permitted by law. If Seller undertakes collection or enforcement efforts, Buyer shall be liable for all costs thereof, including attorneys’ fees.

2.3 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 Seller’s net income, unless Buyer provides a certificate of tax exemption to Seller.

3. Substitutions and Modifications.

Seller will have the right to make substitutions and modifications in the specifications or composition of products or protocols related to products sold by Seller provided that such substitutions or modifications will not materially affect overall product performance.

4. Ownership, No License.

Seller 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 Seller covering or relating to any use other than is consistent with the labeling thereof to which the products may be put.

5. Confidentiality.

Confidential Information” shall include any information disclosed by Seller, or its agents, to Buyer, and shall specifically include any patents and inventions, other intellectual property, the Purchase Price and any revisions by Seller thereto, sales, marketing, or customer lists. Confidential Information does not include any information that is publicly available or becomes publicly available through no breach of Buyer or its employees or agents. Buyer shall maintain the Confidential Information in strictest confidence and take all reasonable precautions to protect such information (including, without limitation, all precautions the Buyer employs with respect to its most confidential matters) and shall take all steps reasonably necessary to maintain the confidential nature of same.

6. Limited Warranty.

6.1 Limited Warranty. Seller warrants to Buyer that, for a period of one (1) year after the shipment date, the products sold hereunder are new and free from substantial defects in workmanship and materials, and will conform to the written specifications provided by Seller for such products. This warranty is contingent upon proper use of the products, in accordance with the applicable instructions for use provided by Seller, in an application or individual for which it was intended and does not apply to any product that is used by unqualified personnel, is subjected to unusual physical or chemical stress, misuse, neglect, improper testing or storage, modification, is used or implanted under improper protocol or is damaged by accident or any act of God. Seller makes no warranty against any failure or defect, material or otherwise, of any product related to, caused by, or exacerbated by any actions of Buyer, its employees, contractors or any other end user. This limited warranty applies only to the original Buyer of Seller’s products and is null and void if the original Buyer transfers such products, whether by sale, lease or any other manner, to another party.

6.2 Limited Remedy. Seller’s entire liability and Buyer’s exclusive remedy is limited to replacement of products or refund of the Purchase Price at Seller’s sole option. Buyer agrees that to obtain any remedy (a) Buyer must promptly notify Seller in writing upon discovery that the products failed to conform to this contract, with detailed explanation of any alleged deficiencies, (b) Buyer must return the products to Seller, and (c) that an examination by Seller shall disclose that such alleged deficiencies actually exist and were not caused by accident, neglect, misuse or alteration by Buyer or any other circumstance that would render the Seller’s warranty in Section 6.1 inapplicable.

6.3 Disclaimer of Warranties. EXCEPT FOR THE LIMITED WARRANTY EXPRESSLY STATED IN SECTION 6.1, THE PRODUCTS ARE PROVIDED “AS IS” WITHOUT REPRESENTATION OR WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED, AND THE SELLER SPECIFICALLY DISCLAIMS ALL EXPRESS OR IMPLIED REPRESENTATIONS AND WARRANTIES, INCLUDING, WITHOUT LIMITATION, ANY WARRANTIES ARISING FROM A COURSE OF DEALING AND ANY IMPLIED WARRANTIES OF MERCHANTABILITY, NON- INFRINGEMENT AND FITNESS FOR A PARTICULAR PURPOSE. No oral or written information or advice given by Seller 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.

7. Buyer Indemnification.

Buyer shall defend, indemnify, and hold harmless Seller 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 arising out of or relating to the use of the products, unless proximately caused by the sole gross negligence or willful misconduct of Seller.

8. Insurance.

Buyer shall procure and maintain in force commercial 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 to cover Buyer and Seller for any liability related to the use of Seller’s products.

9. Limitation of Liability.

Seller’s liability and Buyer’s remedies arising out of or related to the products shall not exceed the Purchase Price paid by Buyer for the products giving rise to such liability. IN NO EVENT SHALL SELLER BE LIABLE FOR COSTS OF PROCUREMENT OF SUBSTITUTE GOODS, LOST PROFITS OR BUSINESS OPPORTUNITIES OR ANY OTHER INDIRECT, 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 SELLER HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGE AND NOTWITHSTANDING THE FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY.

10. Security Interest.

Seller 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 Seller, Seller will have the right to repossess the products sold hereunder without liability to Buyer. On request of Seller, Buyer will execute financing statements and other instruments that Seller may request to perfect Seller’s security interest.

11. Export.

Buyer may not use, export, import, or transfer products except as authorized by U.S. law and any other applicable laws. Without limiting the generality of the foregoing, Buyer shall comply with all applicable U.S. export laws and regulations and shall not, without prior U.S. government authorization, export, re-export, or transfer the products, either directly or indirectly, to any country in violation of such laws and regulations.

12. Adverse Product Experience.

Buyer will inform Seller promptly (but in no event later than twenty-four (24) hours after becoming aware) of any information concerning complaints involving the product or adverse device experiences reported to Buyer in connection with a product, whether or not considered related to the product. All notifications under this Section shall be made by Buyer as directed by Seller. In addition, if a third party notifies Buyer of an adverse experience concerning a product, Buyer will advise the third party to promptly contact the Seller’s Service department at (512) 953-5162

13. Disclosures.

To the extent applicable, Buyer shall disclose all fees and/or discounts required to be disclosed under any state or federal program which provides cost or charge based reimbursement to Buyer for the product provided under the purchase order, as required by applicable laws, including without limitation 42 U.S.C. §1320(a)-7b. Buyer represents and warrants that it shall comply with any federal or state laws applicable to any fees, rebates and/or discounts, if any, paid by Seller pursuant to the purchase order, including any laws requiring the proper disclosure and/or reporting of such fees, rebates or discounts.

14. Government Inspections.

Buyer agrees to cooperate with any inspection of product shipment conducted by a governmental agency. Buyer shall notify Seller promptly of any inspection by any federal, state or local regulatory or governmental representative concerning the product and shall provide Seller with a summary of the results of such inspection and such actions, if any, taken to remedy conditions cited in such inspections. Seller will have the right to review and comment on any written communication to a regulatory authority that is specific to product.

15. Buyer Representations and Warranties.

Buyer represents and warrants to the Seller that it has and will maintain, in full force and effect, all licenses and permits required under applicable federal, state or local law for Buyer to purchase and use products under these terms and conditions. Buyer further represents, warrants and covenants to Seller, on behalf of it, and each of its employees, agents, officers, directors, contractors, or any other individual or entity providing services on behalf of Buyer (each, a “Representative”) that: (i) it is not a party to any oral or written contract or understanding with any third party that will in any way limit or conflict with Buyer’s ability to fulfill these terms and conditions; and (ii) neither it nor any of its Representatives has been debarred pursuant to the Federal Food, Drug and Cosmetic Act, excluded from a federal health care program, debarred from federal contracting, or convicted of or pled nolo contendere to any felony, or to any federal or state legal violation (including misdemeanors) relating to prescription drug products or fraud.

16. Miscellaneous.

These terms contain the entire agreement and understanding between the parties on the subject of the sale of listed products. No representations or statements, other than those expressly set forth herein, were relied upon by the parties in entering into these terms. No modification or waiver of, addition to, or deletion from, the terms of these terms shall be effective unless reduced to writing and signed by duly authorized representatives of the parties hereto. The parties acknowledge that the broad applicability of the products may make them useful in applications for which they were not expressly designed and which may involve dangers to human health or safety such as using products for an individual other than the one which such product was intended, or improper use by a patient after such product is implanted. These terms shall be governed by and interpreted in accordance with the laws of the State of California without reference to conflicts of law principles. Any dispute arising out of these terms shall be brought in, and the parties consent to personal and exclusive jurisdiction of and venue in, the state and federal courts within San Mateo 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 is held to be invalid or unenforceable, the remainder of these terms shall continue in full force and effect and will be interpreted to reflect the original intent of the parties.

Version 1.0 May 12, 2022

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Fiagon NA, LLC
3913 Todd Ln Building 100, Suite 101,
Austin, TX 78744
sales(at)fiagon.com

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