Terms and Conditions

Terms and Conditions

Thank you for your interest in purchasing products. SMART SURGICAL, INC., dba Burst Biologics™, values your business and our goal is to make your experience as smooth as possible. If you have any questions about our purchase and order process, please call our Customer Services at 1-888-322-1191. Unless otherwise expressly agreed in writing, your purchase of products is subject to the following terms and conditions:

 

  1. Contract Terms
    • General Terms. These Standard Terms and Conditions (the “Terms”), our Quotation (if any), our Supplementary Terms (if any), and any other agreement of ours, comprise the agreement (the “Agreement”) between you and SMART SURGICAL, INC.. Unless your order is subject to a separate valid, written, executed agreement between you and SMART SURGICAL, INC., in which case such agreement applies, you agree to accept and be bound by these Terms by either ordering product on burstbiologics.com or if you have received ordering and/or sales documents that reference these Terms. This Agreement is the complete and exclusive contract between us with respect to your purchase and ordering of our products.
    • Terms Conflict. If any conditions within the Agreement documents conflict with each other, we will give them the following priority: our Quotation, Supplementary Terms, other agreement of ours and finally these Terms. We expressly reject any different terms or provisions contained in any document you provide, and if the terms and conditions in this Agreement differ from the terms of your offer, this Agreement will serve as the governing terms for our contract.
    • When Agreement takes Effect. The Agreement between us is created when we; enter into a contract with you, accept your order, either by sending a written confirmation, or by shipping the product or otherwise initiating action to provide what you have ordered.
  2. Price
    • Determining Price. Prices are subject to change any time without notice. Prices we quote you are valid for 30 days, unless we state otherwise in writing. Additionally, the price as shown in our Quotation to you, is subject to adjustment on account of specifications, quantities, raw materials, cost of production, shipment arrangements or other terms or conditions which are not part of our original price quotation with notification. If no price has been specified or quoted to you, the price will be the product list price available from our Customer Services and in effect at the time we accept your order.
    • Taxes and Fees. Our product prices do not include any taxes (including VAT), duties, levies or other government fees that may apply to your order. If they apply, it will be your responsibility to pay them. If you claim any exemption, you must provide a valid, signed certificate or letter of exemption for each respective jurisdiction.
    • Delivery Fees; Freight Policy. You are also responsible for standard delivery and handling charges, if any. We will also add these charges to your invoice. For details of our freight policy, please call our Customer Services.
  3. Payment
    • Payment Terms. We will invoice you for the product price and all other charges due when we ship you the products. Unless we have agreed otherwise in writing, payment is due within 30 days from the invoice date. Each order is a separate transaction, and you may not off-set payments from one order against another. We reserve the right to require you to make full or partial payment in advance, or other security to our satisfaction, if we believe in good faith that your financial condition does not justify the payments terms otherwise specified. All payments are to be made in U.S. Dollars.
    • Payment Methods. We accept paper checks, which must be received within 30 days from the invoice date. Alternatively, we facilitate credit card payment that may be arranged by calling our Customer Services.
    • Late Payment. If you are late in making payment, we may, without affecting our other rights:
      • suspend delivery or cancel the Agreement;
      • reject your future orders; and/or
      • charge you a late-payment charge, from the due date until paid, at the rate of 2% per month, or, if less, the maximum amount allowed by law-which you must pay upon our demand.
    • Collection Costs. If we appoint a collection agency or an attorney to recover any unpaid amounts, you must pay all reasonable costs of collection, including all associated attorneys’ fees.
  4. Delivery and Title
    • Delivery. We will ship products to the U.S. destination you specify in your order, FOB destination. We may, in our discretion, (a) make partial shipments; and/or (b) stop delivery of products in transit and withhold shipments in whole or in part if you do not pay us when due, or if you otherwise do not perform your obligations in this Agreement. Our shipping dates are approximate only, and, if we do delay shipment because of a cause beyond our reasonable control, we may terminate the affected order, or reschedule the shipment, and we will do so within a reasonable period of time. If our delivery of a product to you is delayed due to any cause within your control, we will place the delayed products in storage at your risk and expense and on your behalf.
    • Restrictions. We will ship all properly ordered products on the following weekdays; Monday, Tuesday, Wednesday and Thursday. We do not ship on our observed holidays, which you may obtain from our Customer Services.
      • Next Day. For next day delivery and subject to restriction, a completed purchase order form must be received, by either fax or email, and acknowledged by us no later than 3:00 P.M. MST.
      • Purchase Order Forms. You may request a purchase order form from our Customer Services at any time and for your convenience. If you properly complete an order online, a purchase order shall be generated for you and provided to us through our website. If you choose to submit your own purchase order form, we cannot guarantee completion of your order unless your purchase order form has either been pre-approved by our Customer Services or meets our minimum requirements for order processing, which may be obtained from our Customer Services.
    • Cancellation. Once you have placed your order, you cannot cancel it, unless we consent in writing, and you pay any applicable cancellation charges.
    • Changes. You may not change orders in process, except with our written consent and agreement as to an appropriate adjustment in the purchase price for the applicable products. You will not receive credit for products returned without our prior consent.
    • Risk of Loss. Aside from the trade terms indicated above and subject to our right to stop delivery of products in transit, products are delivered when they reach their destination. At this point you become responsible for risk of loss and damage.
    • Title. Title to products will pass to you when we deliver the product to the destination.
    • Tracking We will include a Tissue Tracking Card with each shipment of product, when applicable, and immediately following the products use this Tissue Tracking Card shall be completed by you and returned to us. You will assume responsibility for FDA, or other regulatory, tracking compliance if the Tissue Tracking Card is not completed and returned to us.
  5. Returns and Shortages
    • Returns and Shortages. You may return a product that is damaged on delivery, or correct any shortages or discrepancies with the packing list, if you contact our Customer Services within 2 business days after receiving the product. If you do not contact us within this 2-day period, we will deem the product accepted and to be in agreement with the enclosed packing list.
    • Authorization for Returns. Our Customer Services must authorize all product returns and no return will be accepted without a prior Return Materials Authorization form (“RMA”). If your product return is authorized, our Customer Services will provide you with directions regarding the return process along with a RMA. Our Customer Services may not authorize some items for return.
    • Product-Credit Eligibility. To be eligible for product credit, a product authorized for return must arrive at our facilities in a condition satisfactory for resale. We do not credit shipping charges.
  6. Intellectual Property
    • Limitation of Rights. As between you and us, we exclusively own all intellectual property rights relating to our products. Unless we expressly state otherwise in Supplementary Terms or other agreement of ours, our selling products to you grants you only a limited, nontransferable right under our intellectual property: only you may use the products you have bought from us and only for your own purposes. No right to transfer, distribute or resell our products or any of their components is conveyed expressly, by implication, or by estoppel. Unless expressly permitted by us in writing, you will not modify, change, remove, cover or otherwise obscure any of our brands, trade or service marks on the products. Nothing in the Agreement limits our ability to enforce our intellectual property rights.
    • Intellectual Property Ownership. We exclusively own all intellectual property rights in any inventions (patentable or otherwise), discoveries, improvements, data, know-how, or other results that are conceived, developed, discovered, reduced to practice, or generated by or for us, or jointly by you and us, in relation to processes, methods, or related synthesis of a product, or otherwise in connection with designing or manufacturing a product. You agree to transfer and assign to us all your right, title, and interest in and to any joint intellectual property. And at our request and at our expense, you will help us secure and record our rights in the intellectual property.
  1. Limitation of Liability

TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, WE WILL NOT BE LIABLE UNDER ANY LEGAL THEORY (INCLUDING BUT NOT LIMITED TO CONTRACT, NEGLIGENCE, STRICT LIABILITY IN TORT OR WARRANTY OF ANY KIND) FOR ANY INDIRECT, SPECIAL, INCIDENTAL, PUNITIVE, MULTIPLE, EXEMPLARY OR CONSEQUENTIAL DAMAGES (INCLUDING BUT NOT LIMITED TO COSTS OF COVER, LOST PROFITS, LOST DATA, LOSS OF BUSINESS, LOSS OF GOODWILL OR LOSS OF REVENUE) THAT YOU MIGHT INCUR UNDER THE AGREEMENT, OR THAT MAY ARISE FROM OR IN CONNECTION WITH OUR PRODUCTS, EVEN IF WE HAD NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. IN ADDITION, OUR MAXIMUM AGGREGATE LIABILITY ARISING OUT OF OR IN CONNECTION WITH THE AGREEMENT, OR ANY PRODUCT, IS LIMITED TO THE AMOUNT YOU PAID TO US FOR THE PRODUCT PURCHASED. HOWEVER, THESE PROVISIONS DO NOT LIMIT OUR LIABILITY FOR DEATH OR PERSONAL INJURY CAUSED BY OUR NEGLIGENCE OR FRAUD, FRAUDULENT MISREPRESENTATION OR ANY OTHER LIABILITY THAT CANNOT BE EXCLUDED BY LAW.

  1. Homologous Use.
    • The products being purchased from Smart Surgical are intended by Smart Surgical to be regulated under 21 C.F.R. 1271 and, in particular 21 C.F.R. 1271.10, as human cells, tissues, and cellular and tissue‑based products (“HCT/Ps”). The HCT/P products purchased from Smart Surgical are intended to only be put to a HOMOLOGOUS USE, as that term is defined in 21 C.F.R. 1271.3(c).  Under 21 C.F.R. 1271.3(c), HOMOLOGOUS USE is defined to mean “the repair, reconstruction, replacement, or supplementation of the recipient’s cells or tissues with an HCT/P that performs the same basic function or functions in the recipient as in the donor.”  It is the purchaser’s obligation and responsibility to determine and ensure that HCT/P products are only put to a HOMOLOGOUS USE, as that term is defined in 21 C.F.R. 1271.3(c).
  1. Miscellaneous
    • Warranty. We make no warranty, whether express or implied, with respect to our products. No affirmation by us, by words or action other that as set forth in this Agreement shall constitute a warranty.
    • No Assignment. You may not delegate any duties nor assign any rights or claims hereunder without our prior written consent, and any such attempted delegation or assignment will be void.
    • Governing Law. The Agreement and performance under it will be governed by Delaware law, without reference to its choice of law provisions. In the event of any legal proceeding between you and us relating to this Agreement, neither party may claim the right to a trial by jury. Any action arising under this Agreement must be brought within 1 year from the date that the cause of action arose.
    • Regulatory Restrictions. You must use our products in accordance with our instructions. You are solely responsible for making sure that the way you use our products complies with applicable laws, regulations and governmental policies. You must obtain all necessary approvals and permissions you may need. It is solely your responsibility to make sure the products are suitable for your particular use.
    • Uncontrollable Circumstances. We will not be responsible or liable for failing to perform our obligations under the Agreement to the extent caused by circumstances beyond our reasonable control. In certain situations, we may use our reasonable judgment and apportion products then available for delivery fairly among our customers.
    • No Waiver; Invalidity. Our failure to exercise any rights under the Agreement is not a waiver of our rights to damages for your breach of contract and is not a waiver of any subsequent breach. If any provision or part of the Agreement is found by any court of competent jurisdiction to be invalid or unenforceable, such invalidity or unenforceability will not affect the other provisions of the Agreement. No person other than you or us will have any rights under the Agreement.
    • Headings. Headings are for convenience only and shall not be used in the interpretation of these Terms.
    • Confidentiality. You agree to keep confidential any non-public technical information, commercial information (including prices, without limitation) or instructions received from us as a result of discussions, negotiations and other communications between us in relation to our products.
    • Notices. Any notice or communication required or permitted under these Terms must be in writing and will be deemed received when personally delivered, received by email or 3 business days after being sent by certified mail, postage prepaid, to a party’s specified address.
    • Requirement to Reduce to Writing. No waiver, consent, modification, amendment or changes to the terms of this Agreement will be binding unless in writing and signed by; (A) you if on our forms; and/or (B) both of us. Our failure to object to terms contained in any subsequent communication from you will not be a waiver or modification of our Agreement.
    • Ordering. For information regarding orders
    • Changes in Agreement. We reserve the right to modify the terms and conditions of the Agreement at any time.