AMNIO TECHNOLOGY, LLC AND ITS AFFILIATES (COLLECTIVELY, “AMNIO TECHNOLOGY”) TERMS AND CONDITIONS (“TERMS AND CONDITIONS”)
Customer agrees to purchase and accept Amnio Technology products (“Products”) in accordance with these terms and conditions. Amnio Technology objects to and rejects any and all terms proposed by Customer, whether contained in Customer’s purchase order or elsewhere. If Amnio Technology and Customer have signed a separate, written agreement governing Customer’s purchase of Amnio Technology Products, then the terms of that agreement shall govern in the event of conflict.
1. INSPECTION; PRODUCT RETURN. Upon receipt of each shipment of the Product, Customer shall promptly inspect such shipment to determine whether the full shipment was received and to confirm that the Product was shipped in validated containers, if applicable, that all observable seals were intact, and that the shipment otherwise meets the shipping and packaging specifications related to the transportation and distribution of human tissue, including, with respect to cryopreserved Product, that it was received within the stated shipment expiry. Customer shall inform Amnio Technology in writing of any claim by Customer relating to a shipment that contains a shortage of the Product, incurred damage during shipment, or that fails to conform to the shipping or delivery specifications for the Products immediately after Customer learns, or should reasonably have learned, of such claim with return to Amnio Technology within forty-eight (48) hours by Returned Material Authorization (RMA). If Customer does not provide such notice to Amnio Technology, Customer shall be deemed to have accepted the shipment of the Product as complete and conforming, as applicable. Upon receipt of any such notice, Amnio Technology, at its sole discretion, may either (i) replace the shortfall or non¬-conforming Product, or (ii) credit Customer for the shortfall or non-conforming Product. The foregoing shall be Customer’s sole remedy in the event of a shortfall or non-conformance claim. Notwithstanding the foregoing, Amnio Technology shall have no liability in the event that the replacement of any Product shall have been necessitated by the fault or negligence of Customer.
2. SHIPMENT/RISK OF LOSS. Sales shall be FOB point of shipment at Amnio Technology’s manufacturing or distribution facility. Customer shall pay freight charges from the point of shipment to the point of delivery. Title and risk of loss shall pass to Customer upon shipment to the destination designated by Customer.
3. PAYMENT. Payment terms are net thirty (30) days from the date of shipment. Any unpaid balance as of the expiration of such 30 days shall bear interest at the rate of 1.5% per month, or, if lower, the highest rate allowed by applicable law. Customer shall be responsible for any and all costs actually incurred by Amnio Technology, including, without limitation, reasonable attorneys’ fees and costs, in collecting any sums due from Customer to Amnio Technology.
4. COMPLIANCE WITH LAW; LICENSES. Amnio Technology and Customer shall comply with all applicable statutes, rules, regulations and standards of any and all governmental authorities and regulatory and accreditation bodies relating to practitioners, hospitals, the provision of healthcare services, and the practice of medicine. Any licenses, permits, certificates or other documents that are required by any governmental authority for the supply and use of the Products hereunder shall be the respective responsibility of Amnio Technology and the Customer. Amnio Technology is not responsible for any violations of applicable laws and regulations by Customer with regard to the distribution and use of the Products.
5. WARRANTIES. Subject to the provisions of this Section 5, Amnio Technology furnishes this Product without any expressed or implied warranties. All statements or descriptions are informational only and are not to be interpreted or implied as a warranty of the Product. The end user is solely responsible for appropriate storage, application and usage of this Product in accordance with the Instructions For Use (IFU), as may be updated from time to time.
Application and use of any tissue may potentially have negative outcomes. Occurrence of complications at the affected site may transpire post-treatment without early warning signs. These include, but are not limited to 1) transmission of communicable diseases, 2) transmission of infectious disease agents such as: bacteria and fungus, viruses; and 3) immune rejection, and/or allergic reaction.
EXCEPT AS EXPRESSLY PROVIDED IN THIS SECTION, AMNIO TECHNOLOGY MAKES NO WARRANTIES OR CONDITIONS, EXPRESS, STATUTORY, IMPLIED, OR OTHERWISE, AND AMNIO TECHNOLOGY SPECIFICALLY DISCLAIMS THE IMPLIED WARRANTIES AND CONDITIONS OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. NOTWITHSTANDING THE FOREGOING, AMNIO TECHNOLOGY DOES NOT EXCLUDE LIABILITY TO THE EXTENT THAT SUCH LIABILITY MAY NOT BE EXCLUDED OR LIMITED BY LAW.
6. EXCLUSIVE REMEDY/LIMITATION OF LIABILITY. If the Products delivered to Customer fail to conform to these Terms and Conditions for any reason whatsoever, Customer’s sole and exclusive remedy shall be as provided herein. Amnio Technology shall not under any circumstances be liable to Customer for (i) any special, exemplary or consequential damages, however caused and under any theory of liability whether based in contract or tort or otherwise or (ii) any claim or demand brought against Customer by any other party, even if Amnio Technology has been advised of the possibility of such claim or demand. Amnio Technology’s liability to Customer for any claim whatsoever related to the Products or these Terms and Conditions, including any cause of action sounding in contract, tort, indemnity, contribution or strict liability, shall not exceed the amount of all payments received by Amnio Technology for the Products that are subject of these Terms and Conditions.
7. INDEMNIFICATION. Customer shall defend, indemnify and hold harmless Amnio Technology from and its respective members, directors, officers, employees and agents from and against any liability and claims of all kinds for any injury to persons or property or any other claims of injury, loss, expense or damage incurred by any employee or customer of Customer or any third party that arises out of the Customer’s breach of its obligations hereunder or is due to the negligent acts, omissions or intentional acts of Customer, its employees, agents, consultants, or subcontractors.
8. FORCE MAJEURE AND DELAY. Amnio Technology shall be excused for any delay in the shipment of any Products ordered due to acts of God, war, the public enemy, mobilization, riot, strike, lockouts, work stoppage or any other labor difficulties, blights, disease, excessive heat, explosion, shortage of cars or other materials, embargoes, acts of civil or military authorities, fires, floods, accidents, quarantine restrictions, carrier conditions, delays in transportation, or any other case of Force Majeure, or circumstances or cause beyond the reasonable control of Amnio Technology. In the event of such an occurrence, Amnio Technology shall give Customer reasonable notice that there will be a delay or non-delivery, upon which notification these Terms and Conditions shall be deemed terminated and Amnio Technology shall have no further obligation to ship the Products covered by these Terms and Conditions. Notwithstanding the preceding sentence, if Customer agrees to a future delivery date in writing, these Terms and Conditions shall continue and Amnio Technology shall deliver the Products on such later delivery date. Amnio Technology shall make every reasonable effort to meet the shipping date specified. In no event, however, will Amnio Technology be liable for its failure to meet such date if the delay is caused by reasons beyond the reasonable control of Amnio Technology. Notwithstanding the foregoing, Amnio Technology shall have no obligation to obtain Product from a third party in order to replace or reimburse for any contractual shortfall.
9. ATTORNEY’S FEES. In the event legal action is pursued with respect to these Terms and Conditions, including, without limitation, actions to interpret or to enforce any of the provisions herein, and if Amnio Technology prevails in such legal action, Amnio Technology shall be entitled to recover from Customer, attorney’s fees and costs reasonably incurred by Amnio Technology in such action, unless prohibited by applicable law.
10. PRODUCT RECALLS. In the event Amnio Technology believes that it may be necessary to conduct a recall, field correction, market withdrawal, stock recovery, or other similar action with respect to any Product, Amnio Technology, as manufacturer of the Products, shall have sole authority with respect to such recall and the parties shall work together to safely and effectively conduct such recall as quickly and efficiently as possible. As directed by Amnio Technology, and immediately upon becoming aware, Customer shall make every reasonable effort to comply with the action, including but not limited to discontinuing distribution and use of the Product. In the event that such recall results from the negligence or willful misconduct of Customer, Customer shall be responsible for the expenses of the recall.
11. PROPRIETARY RIGHTS. Customer agrees that Amnio Technology retains all right, title and interest in and to all patent rights, trademarks, trade names, inventions, copyrights, know-how and trade secrets relating to the Products and the design, processing, manufacture, operation or service of the Products. Customer shall not (and shall require that its customers, if any, do not) remove, alter, cover or obfuscate any proprietary rights notices placed or embedded by Amnio Technology on or in any Product.
12. RECORD KEEPING. Amnio Technology and Customer will keep or cause to be kept in accordance with federal law and applicable regulatory requirements books and records regarding the purchases and sales of Products pursuant to these Terms and Conditions. Customer shall return all tissue utilization records to Amnio Technology, when applicable. Further, to the extent and only to the extent required by law, until the expiration of four years after the furnishing of the Products and services provided under these Terms and Conditions, Amnio Technology will make available to the Secretary of the U.S. Department of Health and Human Services, the U.S. Controller General, and their representatives, these Terms and Conditions and all books, documents, and records necessary to certify the nature and extent of the costs of any Products or services provided hereunder.
13. ENTIRE AGREEMENT/SEVERABILITY. In the event of a conflict between the provisions of these Terms and Conditions and the provisions of a signed, separate written agreement between Customer and Amnio Technology, the terms and conditions of the signed agreement shall prevail. In the event that any of the terms of these Terms and Conditions is, becomes or is declared to be invalid or void by any court of competent jurisdiction, such term or terms shall be null and void and shall be deemed severed from these Terms and Conditions and all of the remaining terms of these Terms and Conditions shall remain in full force and effect.
14. GOVERNING LAW; VENUE. These Terms and Conditions shall be governed by and construed in accordance with the laws of the State of Arizona, without giving effect to its conflict of laws principals. Any demand, suit or cause of action arising out of these Terms and Conditions shall be brought in a state or federal court located in Maricopa County, Arizona. Customer hereby submits to the jurisdiction and venue of such court.
15. NONASSIGNABILITY; AMENDMENTS. Customer shall not assign these Terms and Conditions without the prior written consent of Amnio Technology and any attempt to assign or transfer any of the rights, duties or obligations under these Terms and Conditions without such consent shall render such assignment or transfer null and void. These Terms and Conditions can be amended only in writing executed by Amnio Technology and Customer.