1) TERMS AND CONDITIONS
a) The Terms and Conditions contained herein constitute the entire agreement (“Agreement”) between Spaulding Medical, LLC and Customer. Customer acknowledges that the terms and conditions of Customers Purchase Order are not part of this Agreement.
2) PACKAGING AND SHIPPING
a) Spaulding Medical, LLC shall be responsible for packaging, marking and shipping the products in accordance with good commercial practices and all applicable laws.
3) SHIPMENT AND RISK OF LOSS
a) Shipping point and Risk of Loss shall be FCA shipment origin; freight prepaid and add, in accordance with the most recent version of INCOTERMS.
b) Spaulding Medical, LLC reserves the right to make partial deliveries.
c) The carrier shall not be construed to be an agent of Spaulding Medical, LLC. Spaulding Medical, LLC shall not be held responsible for delays by carrier to make deliveries for any cause.
4) PAYMENT, SERVICE CHARGE AND TAXES
a) Payment is due prior to shipment
b) Customer shall pay all sales, use, property, excise, import or export, value added, any taxes that may be added on the license or sale of a medical device or similar taxes (except Spaulding Medical, LLC’s income or franchise taxes) levied upon the delivery of the products.
5) LIMITED USE
a) No Implied License. Possession of the Equipment does not convey any express or implied license to use the Equipment with unauthorized cables that would, alone, or in combination with the Equipment, fall within the scope of one or more of the patents relating to the Equipment.
b) Qualified Personnel. Customer will not permit the Equipment to be used by anyone other than Customer’s qualified and trained personnel.
c) No Modifications. Except for use of the communication ports provided by Spaulding Medical, LLC to transmit data from the Spaulding Medical, LLC monitors and systems to other equipment, modification or connection of other Equipment to the Spaulding Medical, LLC Equipment, including software, hardware and related instruments cannot be made without Spaulding Medical, LLC’s prior written authorization, which authorization may be withheld at Spaulding Medical, LLC’s sole discretion.
d) Cleared Use Only. The Equipment and Software and related disposable accessories may not be used for any processes, procedures, experiments or any other use for which the Equipment is not intended or cleared by the Food and Drug
Administration (FDA), or in any manner inconsistent with the instructions for use or labeling.
a) License Grant. The Equipment contain Spaulding Medical, LLC proprietary technology and/or software (the “Software”), trade secrets and other proprietary information (collectively, “Intellectual Property”). Spaulding Medical, LLC grants to Customer a non-exclusive, non-transferable, license to use the Software and Equipment in connection with its authorized use of the Equipment in conformance with the instructions for use and labeling and this Agreement. Notwithstanding any other provision of this Agreement, Equipment are licensed, not sold. This Agreement does not constitute a sale of the Software, Equipment, trade secrets, any copy of the Software or any Intellectual Property.
b) Optional Software Parameters. Spaulding Medical, LLC may offer optional software parameters (“Software Parameters”) with additional functionality at the then current license fees. The optional Software Parameters contain Spaulding Medical, LLC Intellectual Property, and are licensed separately from the Software in Section 7a) above. If Customer elects to obtain term license(s) for optional Software Parameters, Spaulding Medical, LLC shall grant to Customer (subject to the Payment terms of this Agreement), a non-exclusive, nontransferable, non-sub licensable, revocable limited term software license to use the optional Software Parameters in accordance with the terms of this Agreement for the term license period. Any license granted to Customer in this Section 7b) is limited to use of the optional Software Parameter solely on a single Spaulding Medical, LLC Electrocardiograph.
c) Additional Software Parameter Licenses. Additional term licenses for the optional Software Parameters may be obtained at any time during the Term of this Agreement. Such additional optional Software Parameter licenses shall become a part of this
Agreement, subject to its licensing provisions.
d) No Modifications. Customer may not reverse engineer, copy, modify, loan, rent, lease, assign, transfer, or sub-license the
Software or Intellectual Property without Spaulding Medical, LLC’s prior written consent, which may be withheld at Spaulding Medical, LLC’s sole discretion; any attempt to do so will render the license null and void and use of the Software and Intellectual Property invalid.
a) Warranty. Spaulding Medical, LLC warrants that the Spaulding Medical, LLC Products provided will materially conform to the published Product specifications of Spaulding Medical, LLC at the time of shipment and be free from material defects in materials and workmanship. Provided that payments are current and Customer is not otherwise in breach of this Agreement, Spaulding Medical, LLC’s obligation if any Spaulding Medical, LLC Products or other accessories are found upon examination by Spaulding Medical, LLC to be defective during the warranty period shall be limited to repair or replacement. Spaulding Medical, LLC is not responsible and will charge Customer for repair, replacement, or maintenance caused by damage, neglect, misuse, improper operation, accident, fire, water, vandalism, weather, war, any Act of God, unauthorized Equipment attached to Spaulding Medical, LLC Equipment, or unauthorized modification of Spaulding Medical, LLC Products or Software. Except as expressly noted herein, all remedies set forth herein are exclusive and in lieu of all other representations and warranties, oral or written, express or implied.
b) Standard Warranty. For Equipment, the duration of the warranty shall be one (1) year from the date of first use, not to exceed fourteen (14) months after shipment; for patient cable, batteries and other accessories, the duration of the warranty is six (6) months from the date of first use, not to exceed eight (8) months after shipment. This warranty does not apply or extend to any Product (i) damaged, neglected, misused or improperly operated; (ii) modified, disassembled, or reassembled; (iii) used with supplies, devices or electrical work external to the Products or not manufactured by Spaulding Medical, LLC; (iv) used with other accessories other than those manufactured and distributed by Spaulding Medical, LLC;
(v) put to a use or used in environments for which they are not intended; and (vi) where the Software has been damaged, modified by anyone other than Spaulding Medical, LLC or without the express written authorization of Spaulding Medical, LLC, or used contrary to Spaulding Medical, LLC’s instructions. Spaulding Medical, LLC’s warranty does not extend to any equipment or software not manufactured by Spaulding Medical, LLC. For equipment manufactured by third-parties, Spaulding Medical, LLC will pass on to Customer all terms and rights provided by the manufacturer. THE FOREGOING WARRANTY IS IN LIEU OF AND EXCLUDES ALL OTHER EXPRESS OR IMPLIED WARRANTIES, ARISING BY OPERATION OF LAW OR OTHERWISE, AND NO OTHER WARRANTIES EXIST, INCLUDING, WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR PARTICULAR PURPOSE.
8) LIMITATION OF LIABILITY.
a) SPAULDING MEDICAL, LLC SHALL NOT BE LIABLE FOR ANY SPECIAL, PUNITIVE, INDIRECT, INCIDENTAL, ECONOMIC OR CONSEQUENTIAL DAMAGES OR LOSSES RESULTING FROM THIS AGREEMENT OR OUT OF THE USE OR INABILITY TO USE THE PRODUCTS OR SUPPORT PROVIDED BY SPAULDING MEDICAL, LLC, INCLUDING BUT NOT LIMITED TO CLAIMS FOR LOST BUSINESS, LOST PROFITS, LOSS OF GOOD WILL, LOSS OF DATA, DATA RECOVERY COSTS, OR ANY OTHER TYPE OF INDIRECT DAMAGES, EVEN IF SPAULDING MEDICAL, LLC HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
a) Bodily Injury. Spaulding Medical, LLC will defend, indemnify and hold Customer harmless against any and all liability, loss, damages, costs or expenses that Customer may hereafter incur, as a result of any injury, illness or death of any person which is caused by any Products, to the extent that such injury, illness or death resulted from failure of any Product at the time of shipment to Customer to materially comply with its published specification. Spaulding Medical, LLC will indemnify third party monitors that contain Spaulding Medical, LLC SET under license from Spaulding Medical, LLC to the extent that the Spaulding Medical, LLC technology is the cause of any bodily injury.
b) Infringement. Spaulding Medical, LLC will defend, indemnify and hold Customer harmless against infringement or alleged infringement directly resulting from standard Products furnished under this Agreement, of any patent, copyright, trademark, trade secret or any other proprietary right of any third party. In the event of such claim, Spaulding Medical, LLC may, at its sole discretion, (i) modify the particular Product to make it non-infringing, (ii) obtain a license to allow the continued use of the Product, or (iii) terminate this Agreement, and take possession of and refund all fees paid for the infringing Products, and pay fair market value, but no more than the price paid by Customer for the infringing Product, if any.
c) Exclusions. Spaulding Medical, LLC shall have no liability or responsibility of any kind to Customer under this Section (“Indemnification”) unless Customer (i) promptly notifies Spaulding Medical, LLC of such claims, (ii) gives Spaulding Medical, LLC an adequate opportunity to defend, including complete control of such defense, and (iii) provides reasonable assistance to Spaulding Medical, LLC, at Spaulding Medical, LLC’s expense and request, in connection with the defense and settlement of any such claim. Spaulding Medical, LLC shall have no liability for settlements made without Spaulding Medical, LLC’s express written consent. Should Customer desire to have its own counsel participate in any such action, the cost of such counsel shall be exclusively Customer’s. Notwithstanding the above, Spaulding Medical, LLC shall not be liable for any infringement of intellectual property rights of third parties or for any liability, loss, damages, costs or expenses which Customer may incur as a result of any injury, illness or death resulting from (i) alterations or modifications to the Products made by Customer or others (or by Spaulding Medical, LLC, in the case of an infringement claim) at Customer’s request, (ii) electrical/electronics, software/firmware, sensors, or product interface not furnished by Spaulding Medical, LLC, (iii) combination of the Products with other apparatus or technology not furnished or, in the case of infringement claims, specified in writing by Spaulding Medical, LLC, (iv) use of Products or components not supplied by Spaulding Medical, LLC, (v) use of Products not permitted under this Agreement, (vi) Products improperly used (including use past the expiration date where applicable) or maintained, or used where defects arose from normal wear and tear; or (vii) for any claims not related directly to the Products. The preceding sentence does not exclude Spaulding Medical, LLC’s indemnification obligations for claims arising out of Spaulding Medical, LLC
SET or Rainbow SET technology contained in OEM Monitors or the combination of such technology with Spaulding Medical, LLC Products.
10) RELATIONSHIP BETWEEN PARTIES
a) Nothing in this Agreement shall be construed as creating any partnership, joint venture or agency between the parties.
a) All notices shall be in writing and delivered either by hand, facsimile or certified mail at the following address: Spaulding Medical, LLC 525 S Silverbrook Dr. West Bend, WI 53095. Notice shall be deemed to have been given upon receipt if delivered by hand or facsimile, or if given by certified mail, upon expiration of seven days after mailing.
12) APPLICABLE LAW
a) This Agreement is governed by the laws of the State of Wisconsin without regard to its conflict of laws provisions.
13) LEASE TRANSACTIONS:
a) If Customer converts its Product purchase into a lease through a third party financer, then Customer acknowledges that its financer will buy the Product from Spaulding Medical, LLC and will own the Product, that Customer is legally obligated to remit payments specified by Customer’s lease to its lessor, and that its lessor and not Spaulding Medical, LLC will have all subsequent financial interest in the Product (but the Product warranty stated below will still apply). Customer further acknowledges that any and all disputes that may arise during the term of its lease with respect to payment for the Product will be between Customer and Customer’s financer, and Customer waives any and all rights and recourse against Spaulding Medical, LLC with respect to such disputes and/or payments.
a) In the event that Spaulding Medical, LLC releases a Product that is a direct replacement for, or a direct substitute or alternative with equivalent function and performance specifications to an existing Sensor or other product covered by this Agreement, then Spaulding Medical, LLC, at its discretion and upon written notice to Customer may substitute, on a going forward basis, the existing Sensor or Product covered by this Agreement with such new Sensor or other product replacement at no additional charge to Customer.
15) REIMBURSEMENT COVERAGE:
a) Customer acknowledges and confirms that: (a) Customer has reviewed and understood all rules and guidelines for Medicare and other public and private insurance reimbursement coverage applicable to Spaulding Medical, LLC technology; (b) all reimbursements for test procedures done with Spaulding Medical, LLC Products are subject to Customer’s compliance with requirements & policies set by Medicare and other public or private insurance carriers, and neither those requirements & policies nor Customer’s compliance with them are within Spaulding Medical, LLC’s responsibility or control; (c) Spaulding Medical, LLC and its representatives have made no representation, warranty or guarantee to Customer of payment or reimbursement by any public or private insurance carrier for any tests done with Spaulding Medical, LLC Products, and (d)
Spaulding Medical, LLC is not responsible or liable to Customer in any way for any costs, damages, amounts, etc. that may arise or be incurred if any insurance carrier denies reimbursement for any tests the Customer does with a Spaulding Medical, LLC Product.
16) SALES FINAL
a) ALL SALES UNDER THIS AGREEMENT ARE FINAL. SPAULDING MEDICAL, LLC WILL ACCEPT NO PRODUCT RETURNS AND WILL NOT BE LIABLE TO CUSTOMER OR ANY THIRD PARTY FOR ANY CONSEQUENCES OF ANY UNAUTHORIZED RETURN. ANY EXCEPTIONS TO THIS PARAGRAPH MUST BE APPROVED BY SPAULDING MEDICAL, LLC IN WRITING IN ADVANCE.
17) SAFE HARBOR
a) The terms of this Agreement are permitted under the discount safe harbor of 42 C.F.R. § 1001.952(h) which is a statutory exception to the anti-kickback law specifically where the offer and acceptance are part of an arms length transaction and two conditions are met, namely that (i) the discount must be fixed and disclosed in writing to Customer at the time of the transaction and (ii) Customer must disclose the arrangement to the government if requested; and a discount arrangement where Spaulding Medical, LLC gives away or reduces the price of one Product in connection with the acquisition of another are explicitly permitted under 64
Fed. Reg. 63530.
18) COMPLIANCE WITH LAWS
a) Spaulding Medical, LLC warrants that in performance of a Purchase Order it has complied with or will comply with all applicable federal, state and local laws and ordinances including, but not limited to, OSHA, the Fair Labor Standards Act, as amended and Executive Order 11246, as amended. In addition, Spaulding Medical, LLC shall secure and maintain adequate Worker’s Compensation coverage.
19) GOVERNMENT CONTRACTS
a) Spaulding Medical, LLC warrants that in the performance of a Purchase Order it has complied with or will comply with all Federal Acquisition Regulations or their counterpart for other governmental agencies, which are applicable to the products or services purchased hereunder. Upon request, Spaulding Medical, LLC shall certify compliance with any of the aforementioned rules or regulations.
20) ACKNOWLEDGEMENT AND ACCEPTANCE
a) Spaulding Medical, LLC reserves the right to revoke this offer at any time prior to its acceptance. This Agreement contains the entire understanding between Spaulding Medical, LLC and Customer; supersede all prior understandings, written or oral, regarding the subject of this Agreement; and may only be amended, modified or superseded by a written agreement signed by Spaulding Medical, LLC and by Customer. Only an authorized representative of Spaulding Medical, LLC and Customer has the authority to sign such amending document.
1) TERMS AND CONDITIONS