SPR Therapeutics

SPRINT PNS System

Product Terms & Conditions

The following document describes SPR Therapeutics’ Terms and Conditions for Sale of Product 

  1. Overview and Definition of Terms. All products, component, goods, and any other items (the “Product(s)”) offered for sale by SPR Therapeutics (“SPR”) are sold subject to these terms and conditions of sale (the “Terms and Conditions”) to a buyer (“Buyer”) (collectively, the “Parties”). The Terms and Conditions shall apply to any contract documentation to which the Terms and Conditions are attached or incorporated by reference. Except as expressly agreed by an officer of SPR in writing, no other terms and conditions, including any terms and conditions attached to, or contained within Buyer’s request for quotation, acknowledgment, purchase order or other contract documentation, shall apply or have any force or effect. Buyer’s acceptance of the Products delivered by SPR shall constitute an affirmation by Buyer that the Terms and Conditions govern the purchase and sale of the Products. SPR’s acceptance of any offer is expressly made conditional on Buyer’s assent to any additional or different terms in these terms and conditions. The Terms and Conditions are subject to change on thirty (30) days’ written notice to Buyer.
  2. Waiver. The provisions of these Terms and Conditions may not be waived, modified, or amended in any way by conduct, custom or course of dealing; instead, they may be waived only by a written document signed by both Parties.  The waiver by a Party of any provisions of these Terms and Conditions will not be deemed to be a waiver of any subsequent breach by the other party of the same term or condition or any other term or condition of these Terms and Conditions. 
  3. Severability.  If any part, term, or provision of these Terms and Conditions is held to be illegal, in conflict with any law, or otherwise invalid, the remaining portion or portions shall be considered severable and not be affected by such determination, and the rights and obligations of the parties will be construed and enforced as if these Terms and Conditions did not contain the particular part, term, or provision held to be illegal or invalid.
  4. Compliance with Laws. SPR and Buyer shall comply with all applicable federal and state laws and regulations, including, without limitation, the Federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b, any applicable “exceptions” or “safe harbors” under the Federal Anti-Kickback Statute with respect to the Buyer’s purchase of Products, any state laws comparable to the Federal Anti-Kickback Statute, and the U.S. Safe Medical Devices Act of 1990.
    • Federal Anti-Kickback Statute.  Each Party represents and warrants that it shall comply with all applicable federal and state laws and regulations, including, without limitation, the Federal Anti-Kickback Statute, 42 U.S.C. § 1320a-7b, any applicable “exceptions” or “safe harbors” under the Federal Anti-Kickback Statute with respect to the Buyer’s purchase of Products, and any state laws comparable to the Federal Anti-Kickback Statute. In particular, both Parties expressly acknowledge that the Federal Anti-Kickback Statute prohibits “illegal remuneration”, as defined therein, in connection with the provision of goods or services for which payment may be made in whole or in part under Medicare or another Federal health care program.
    • Discount Safe Harbor.  Pricing terms for the Products reflected on the invoice may reflect a discount or reduction in price (including discounts, rebates, free goods and contractual allowances) that must be reported in connection with any costs claimed or charges made to federal health care programs in accordance with the provisions of 42 U.S.C. § 1320a- 7b(b)(3)(A) and/or 42 C.F.R. § 1001.952(h) and any other federal, state or private payer requirements. Buyer agrees that it shall (i) fully and accurately disclose the cost of all Products (including any components) provided to Buyer, including any discounts, rebates or other price reductions, in cost reports or claims for reimbursement by Buyer to Medicare, Medicaid or other healthcare programs requiring such disclosure; (ii) provide such documentation to representatives if the Secretary of the Department of Health and Human Services or SPR, as applicable, upon request; (iii) ensure the discount, rebate or other price reduction is based on purchases of the same good bought within Buyer’s fiscal year; and (iv) claim the benefit in same fiscal year or the following year in which the discount, rebate or price reduction is earned. Unless otherwise noted, the value of any Products listed as $0.00 on any invoice may constitute a discount, which should also be evaluated by Buyer when filing such reports. Furthermore, Buyer represents and warrants that it has independently determined that the Products are in the best clinical interest of Buyer’s patients.
    • Food and Drug Administration Regulations.  Buyer acknowledges that it is familiar with the U.S. Safe Medical Devices Act of 1990 (the “Devices Act”) and the reporting obligations imposed on device users thereunder. In this regard, Buyer agrees to notify SPR within 10 days of the occurrence of any event identified in the Devices Act imposing a reporting obligation on Buyer and/or SPR (except for events representing an imminent hazard that require notification to the U.S. Food and Drug Administration (the “FDA”) within 72 hours (or such shorter time as required by law), in which case, such notice will be delivered to the FDA and SPR within said period). Buyer will maintain adequate tracking for the Products to enable SPR to meet the FDA requirements applicable to the tracking of medical devices to the patient-level through the Unique Device Identification (UDI) system associated with each SPR Product and its components.
    • Seller’s HIPAA Obligations. SPR is not a Business Associate as defined in the Health Insurance Portability and Accountability Act (“HIPAA”). The functions SPR is required to perform hereunder, e.g., providing guidance on the safe use of SPR’s products, do not require the use or disclosure of Protected Health Information (“PHI”). To the extent any disclosure of PHI does occur, it is incidental and covered under the incidental disclosure rule found in 45 CFR § 164.502(a)(1).
  5. Confidential Information. All information provided to Buyer, and in particular, information relating to pricing, use, and support of the Product, is deemed “Confidential Information.” Subject to its disclosure obligations described within these Terms and Conditions, Buyer shall not to disclose such Confidential Information to any third party, or to use such information for any other purpose. Confidential Information shall not be deemed confidential if: (i) it is or becomes public knowledge through no fault of Buyer, or (ii) it is required to be disclosed by law, provided that Buyer shall give maximum practical advance notice of same and request such confidential treatment of such disclosure from the recipient as may be afforded by law.
  6. Use of Intellectual Property.  Buyer may not use the “SPR Therapeutics”, “SPRINT”, or “MicroLead” product names or any of SPR’s trademark, service mark, logo, or copyrighted work for any purpose. The sale of the Product by SPR does not constitute a license, implied or otherwise, to any patents, intellectual property, trade secrets or know-how of others, nor does it constitute a license, implied or otherwise, to patents, intellectual property, trade secrets or know-how of SPR, except to the extent that the use of such Product by Buyer is in accordance with instructions provided by SPR and such instructed use itself is covered by the claims of a patent(s) owned by or licensed to SPR. SPR grants to Buyer a non-exclusive, non- transferable, non-sublicensable, revocable, license to the SPR owned patents that have a claim covering the Product or use thereof in accordance with the instructions provided by SPR; provided that the Buyer only uses the Product in accordance with such instructions provided by SPR.
  7. Prices and Taxes. The Products are invoiced at the price agreed upon at the time of acceptance of the Buyer’s order. Such prices invoiced are based upon the Sales Price as set forth therein. Prices do not include, and Buyer will pay or reimburse SPR for, any and all taxes (other than SPR’s income taxes) and other governmental fees, assessments, duties and charges that are payable as a result of this transaction.
  8. Delivery Terms and Title. Unless otherwise agreed by SPR in writing, all shipments to points in the U.S. will be delivered by SPR FOB from SPR’s U.S.-based shipping point. In the case that Buyer advises SPR that it will arrange and take responsibility for shipment of Products from SPR’s U.S.-based shipping point, SPR will arrange for Buyer’s freight forwarder and/or carrier(s) to transport the Products to Buyer’s specified location. Title to and risk of loss or damage for all Products will pass to Buyer upon SPR’s delivery of the Products to the carrier. In all cases of damage and/or loss to Products in transit, Buyer will be responsible for making claim(s) against the carrier; provided, however, that SPR will provide reasonable assistance with damage and/or loss claims. Loss or damage will not relieve Buyer of any obligations for payment or obligations under these Terms & Conditions. Delivery dates provided by SPR are estimates only. Unless otherwise agreed by SPR in writing, shipping, freight, handling, insurance, and related costs are the sole responsibility of Buyer and will be “pre-paid and added” or otherwise invoiced to Buyer. Expedited orders received by 12:00 P.M. Eastern Time will be shipped on the same business day subject to product availability.
  9. Changes to Product Order. After acceptance by SPR, Buyer’s order will not be subject to cancellation or reduction in any amount without SPR’s written consent. Any other changes to an order requested by Buyer will require the prior written approval of SPR, which approval may be subject to price adjustments as determined on a case-by-case basis.
  10. Return Product Policy. Authorization to return Products is required for all returns and may be withheld at the sole discretion of SPR. Defective Product must be returned to SPR within thirty (30) days from the invoice date, under a Return Goods Authorization (RGA) obtained from SPR. SPR will examine the returned Product and determine whether it is defective under the terms of the Limited Warranty below. Product that is opened (including the opening of and/or tampering with any packaging), damaged, expired or tampered with may not be returned for credit at any time except when a warranty claim is made. Shipping damage claims must be made by Buyer directly with the shipping company in accordance with such company’s policies, and Buyer will advise SPR of such claims. Products which have been opened (including Products for which the packaging has been opened or tampered with in any way) – regardless of whether they were exposed to human tissue in any way, should be returned using an SPR-provided biohazard shipping bag and box (or similar) to ensure potentially biohazardous materials are properly quarantined to prevent exposure and/or contamination of processing personnel.
  11. No Resale. Buyer represents to SPR that it is purchasing the Products to provide to its patients for the patient’s own use.  Buyer shall not resell the Products to any third party for sale or resale.
  12. Governing Law and Venue. These Terms and Conditions, any sales of Product by SPR to Buyer, and any claim, dispute, or controversy between SPR and Buyer shall be governed by and construed in accordance with the Laws of the State of Ohio without regard to conflicts-of-law principles, and dealt with under the exclusive jurisdiction and exclusive venue of the federal or state courts located in the Northern District of Ohio. SPR and Buyer expressly and irrevocably agree to submit to the jurisdiction of such courts.
  13. Limited Warranty; Limitation of Liability. SPR warrants to Buyer that upon delivery, Products manufactured by SPR that are sold to Buyer will be free from defects in material and workmanship under normal use consistent with regulatory clearance for the Product until the earlier of: (a) the expiration date of the Products; or (b) sixty (60) days from the date of implantation of the Product in a patient (“Limited Warranty”). Product complaints may be reported to SPR at any time, but to qualify for the foregoing warranty the defective Product must be returned to SPR in accordance with the return procedure described in the “Return Product Policy” above. The foregoing Limited Warranty shall be void with respect to any Product that following delivery: (a) has been subject to accident, abuse, misapplication, modification other than at the direction of SPR; or (b) has been improperly stored or used, (c) has expired; or (d) has been used for something other than the Product’s intended purpose. Buyer assumes all liability resulting from the misuse or abuse of the Product.

    BUYER’S SOLE AND EXCLUSIVE REMEDY FOR A BREACH OF WARRANTY HEREUNDER IS TO HAVE SPR PROMPTLY REPLACE THE PRODUCT. BUYER SHALL HAVE NO OTHER REMEDIES UNDER THIS LIMITED WARRANTY.

    NOTWITHSTANDING ANYTHING HEREIN TO THE CONTRARY, SPR IS NOT LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, PUNITIVE OR CONSEQUENTIAL DAMAGES, ARISING FROM THE PRODUCT, WHETHER BASED ON WARRANTY, CONTRACT, TORT OR OTHERWISE, AND WHETHER OR NOT EITHER PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

    EXCEPT AS EXPRESSLY PROVIDED IN THIS LIMITED WARRANTY, SPR MAKES NO WARRANTY OF ANY KIND, EXPRESS, IMPLIED, STATUTORY OR OTHERWISE, INCLUDING WITHOUT LIMITATION, ANY WARRANTY OF DESIGN, MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, WHETHER ARISING FROM STATUTE, COMMON LAW, CUSTOM OR OTHERWISE. THIS LIMITED WARRANTY WILL NOT BE EXPANDED OR OTHERWISE MODIFIED BY SPR’S RENDERING OF TECHNICAL OR OTHER ADVICE OR SERVICE IN CONNECTION WITH THE PRODUCTS.

    SPR makes no representation or warranty that the Product, in the environment of the human body, will not fail or the human body will not react adversely to the use or implantation of the Product. Suitability of the Product for a particular patient is solely a matter of the professional medical judgment of the treating medical provider(s).

    This Limited Warranty is made only to, and the remedies set forth in this Limited Warranty are only available to the original purchaser of the Product. No person has any authority to change any of the foregoing or assume or bind SPR to any additional liability or responsibility in connection with this Limited Warranty. Buyer’s acceptance of the Product shall be deemed acceptance of the terms and conditions of this Limited Warranty.

    If any part or term of this Limited Warranty is held to be illegal or unenforceable by a court of competent jurisdiction, the validity of the remaining portions of this Limited Warranty shall not be affected, and the rights and obligations shall be construed and enforced as if this Limited Warranty did not contain the part or term determined to be illegal or unenforceable.

Last Updated: June 30, 2023