General Terms and Conditions of Sale
The following General Terms and Conditions of Sale (together with any attached Schedules, these "General Terms") will apply to the sale by Otsuka ICU Medical LLC or its Affiliates (“Otsuka ICU Medical”) to the Customer ("Customer") of any Products (as defined below) unless subject to a separate written agreement between Otsuka ICU Medical and its Affiliates and Customer.
1. Products
1.1. Customer may not sell, distribute, convey, barter or otherwise transfer the Products purchased from Otsuka ICU Medical except to individual persons in the course of providing health care services for use solely at Customer’s sites without the prior express written agreement of Otsuka ICU Medical.
1.2. Customer may not export or re-export a Product.
1.3. Customer shall use the Products only in accordance with the Product Documentation.
1.4. Otsuka ICU Medical may make changes to the specifications of the Products and at any time when, according to Otsuka ICU Medical’s assessment, such changes are required for such Products to conform to existing or future legal, regulatory, or technological requirements. Further, Customer accepts and agrees that Disposables may be subject to minor evolutions and modifications from time to time, at Otsuka ICU Medical’s discretion, and Otsuka ICU Medical shall inform Customer as and when these occur.
1.5. In addition to the foregoing, Otsuka ICU Medical may, immediately upon written notice to Customer, remove or cease use of a Product as may be required by Otsuka ICU Medical in determination with applicable regulatory bodies or as determined to be required by counsel of Otsuka ICU Medical.
1.6. Otsuka ICU Medical reserves the right to delay shipping or allocate the supply of a Product, as the case may be, in the event of shortage, Force Majeure Event, or any other event which disrupts or is reasonably expected to disrupt the ongoing supply of Products, as the case may be, to Customer. Otsuka ICU Medical will not be liable for loss or damage of any kind resulting from any delay in delivery or failure to supply ordered Products or otherwise carry out its obligations under this agreement due to causes beyond its control, and no such event will relieve Customer of its obligations to make payments for other deliveries under this agreement.
2. Orders
2.1. Orders shall be deemed accepted when Otsuka ICU Medical issues a written confirmation or, if no confirmation is issued, upon shipment of the Products by Otsuka ICU Medical.
2.2. Unless specifically provided otherwise in writing by Otsuka ICU Medical, all Orders, offers, and quotes and their acceptance shall be governed by these General Terms, which shall supersede and exclude any terms and conditions proposed, stipulated or referred to by Customer.
2.3. Orders with a combined value of less than $250.00, placed by the Customer under, and subject to, these General Terms, excluding freight, will incur a minimum handling charge of $50.00.
2.4. Orders are not subject to cancellation. A re-stocking fee will be charged for cancelled Orders (if cancelled after Order has been packaged for transit).
2.5. Deliveries pursuant to an Order may not be rejected. A re-stocking fee, and shipping and handling will be charged for deliveries refused.
2.6. Otsuka ICU Medical will invoice Customer for any such fees and payment will be due within thirty (30) days.
3. Invoicing and Payments
3.1. Otsuka ICU Medical shall invoice Customer for Products upon shipment.
3.2. Payment terms are net thirty (30) days paid by EFT, if available, from the date of invoice (“Due Date”). If Customer fails to pay or procure payment of the full amount when due, and without in any manner excusing such violation, Customer agrees to pay Otsuka ICU Medical interest at a rate of +1.5% per month (or the highest rate permitted by applicable laws, if lower) from the invoice Due Date up to and including the date full payment is received by Otsuka ICU Medical. In addition, non-payment of an invoice when due may, at the sole option of Otsuka ICU Medical, result in (i) the acceleration of all outstanding invoices and (ii) the suspension or cancellation of outstanding Orders.
3.3. To the extent permitted by Applicable Law, Customer will be responsible for any and all applicable taxes, fees, and assessments due in relation to its receipt of Products. Customer will pay or promptly reimburse Otsuka ICU Medical for, any and all taxes, other governmental fees, assessments, duties and charges that are payable as a result of this transaction. Customer shall be responsible for maintaining current state tax exemption certificates where applicable and shall forward copies to Otsuka ICU Medical upon request.
3.4. Customer also agrees to pay all collection costs, expenses and reasonable attorneys’ fees for collection of any amount due and unpaid. Otsuka ICU Medical also reserves the right to require from Customer, at any time, satisfactory assurance of performance of Customer’s payment obligations to Otsuka ICU Medical, and refusal or failure promptly to furnish such assurance will entitle Otsuka ICU Medical to suspend or cancel further deliveries to Customer.
3.5. Customer shall not be entitled to retain or defer payment of any sums due to Otsuka ICU Medical hereunder on account of any right to counterclaim or set-off which it may allege against Otsuka ICU Medical.
4. Terms of Delivery - Risk, Title, and Security
4.1. Title to, and risk of loss of Products shall pass to Customer upon shipment of such Products to Customer FOB Origin, Freight Collect in accordance with the shipping and delivery terms. As from point of shipment, any risk of and responsibility for loss, damage and/or costs in connection with such Products shall rest upon Customer including storage, cartage and transportation of the Products as well as any and all insurance, fees, charges, and taxes. Customer shall organize the pickup of Products by a reputable carrier, and shall obtain, at its cost, insurance for loss or damage to Products during shipment.
4.2. Any delivery dates are estimates only.
5. Delivery Inspection
5.1. Customer or its carrier shall make reasonable efforts to inspect the Products immediately at delivery and shall note any (i) discrepancy between the corresponding Order and the delivered Products (quantities, specifications) and (ii) any visible damage to Products or packaging (together the “Contested Products”), on the bill of lading, and shall take sufficient photos to identify any visual damage and shall advise Otsuka ICU Medical in writing within five (5) days of each delivery of any Contested Products, (including all applicable Otsuka ICU Medical warranties).
5.2. Except for any Contested Products identified by Customer on the bill of lading or in writing within five (5) days of delivery, Customer’s receipt of the Products shall constitute an unqualified acceptance of the delivery of such Products and a waiver by Customer of all claims with respect to such delivery. Customer’s acceptance of delivery shall in no way affect or diminish Otsuka ICU Medical’s Product warranties as set out herein.
5.3. Products purchased are not refundable under any condition except as otherwise set forth herein or in Otsuka ICU Medical’s Returned Goods Policy available at Returned Goods Policy. Notwithstanding the foregoing, Customer is entitled to the applicable warranty for such Products as provided herein.
6. Maintenance and Training
6.1. Prior to the first clinical use of any Products, Customer agrees that Customer and all of Customer’s personnel utilizing the Products are required to read all Product Documentation and complete all training provided by Otsuka ICU Medical for the Products. Customer understands and acknowledges that inherent risk exists in not all of Customer’s personnel reading the Product Documentation and completing the required training as provided by Otsuka ICU Medical for the Products. Customer understands that it is responsible for ensuring completion of the training by all Customer’s personnel utilizing the Products.
6.1.1. Online Product Documentation and training resources are available at: Clinical Education Resource Portal for IV Solutions.
6.1.2. For any further training for additional Products, please contact Customer Care.
7. Customer Data
7.1. To the extent that Customer data is created under these General Terms or relationship, Customer retains all rights, title, and interest thereto. Customer hereby grants the following rights to Otsuka ICU Medical in relation to Customer-generated data created, to access, use, process, and disclose such Customergenerated data as may be required for Otsuka ICU Medical to comply with Applicable Laws to Product manufacturers, for complaint investigation, handling and reporting, and for maintaining, developing and improving Otsuka ICU Medical’s products.
8. Cleaning and Decontamination
8.1. At all times, Customer shall use Otsuka ICU Medical-approved cleaning solutions and techniques for Products in accordance with Product Documentation.
9. Intellectual Property
9.1. All rights, title and interest in and to the Products and any associated documentation and all derivative works thereof prepared by or for Otsuka ICU Medical and its Affiliates and all related know-how and all rights therein (including, without limitation, all intellectual property rights), are and shall remain the exclusive property of Otsuka ICU Medical and its Affiliates. All suggestions for corrections, changes, additions or modifications to the Products provided by Customer and any other feedback provided by Customer are the exclusive property of Otsuka ICU Medical and Customer hereby assigns all rights in and to any such feedback to Otsuka ICU Medical, without any right to compensation or attribution.
10. ICU Warranty
10.1. Product Warranty. Otsuka ICU Medical warrants that the Products sold to Customer:
10.1.1. meet both Otsuka ICU Medical’s specifications, and will be manufactured in accordance with all current Good Manufacturing Practices and other Applicable Laws in effect at the time of manufacture,
10.1.2. are free of defects in workmanship and material, and
10.1.3. comply with Applicable Laws and meet stated standards and regulations.
10.2. Warranty Periods. The Otsuka ICU Medical Product warranty periods for the Products is ninety (90) days from the date of Shipment to Customer.
10.3. Warranty Obligations for Products. All Product warranty replacements or refunds shall be limited to Product issues which are, as reasonably determined by Otsuka ICU Medical, due and traceable to defects covered by the corresponding Product’s warranty. Customer’s sole and exclusive remedy, and Otsuka ICU Medical’s sole obligation, under the Product warranty shall be for Otsuka ICU Medical to:
10.3.1. replace the Product under warranty, or
10.3.2. if, in Otsuka ICU Medical’s sole opinion, the Product cannot be replaced, in particular where such actions would not be commercially reasonable or feasible, refund or credit (at Otsuka ICU Medical’s discretion) any sums paid by Customer to Otsuka ICU Medical for the Product under warranty.
10.4. Voiding of Warranties. The warranties set out herein shall not apply and shall be void if, and to the extent that, the corresponding Products have been:
10.4.1. damaged, misused, neglected or subjected to improper storage while in Customer’s possession;
10.4.2. used, handled, maintained, or implemented other than in accordance with their Product Documentation, such prohibited uses including but not limited to:
10.4.2.1. re-use of single-use Products;
10.4.2.2. use of single-use Products beyond the indicated maximum duration of use;
10.4.2.3. use of Products with any other products or devices other than those explicitly authorized by Otsuka ICU Medical and as stated in the Product Documentation;
10.4.2.4. cleaning, modification, or fitting of Products with non-Otsuka ICU Medical approved components or cleaning agents;
10.4.2.5. altered by Customer, including defacement;
10.4.2.6. resold, leased or otherwise transferred possession to the benefit of a third party;
10.4.2.7. damaged due to environmental conditions;
10.4.2.8. used by Customer notwithstanding the fact that Customer knew or ought to have known the Product was defective or damaged.
10.5. Exclusion of other Warranties. EXCEPT FOR THE WARRANTIES SET FORTH IN THESE GENERAL TERMS, OTSUKA ICU MEDICAL DISCLAIMS ANY AND ALL OTHER REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT. THE REMEDIES SPECIFIED HEREIN ARE THE SOLE AND EXCLUSIVE REMEDIES AND APPLY REGARDLESS OF WHETHER ANY REMEDY SET FORTH HEREIN FAILS OF ITS ESSENTIAL PURPOSE.
11. Indemnification and Limitation of Liability
11.1. Each Party (“Indemnifying Party”) shall indemnify, defend and hold harmless the other party and its authorized representatives and agents (“Indemnified Party”) from and against any and all liabilities, losses, or damages, expenses, demands, claims, suits or judgments, including without limitation reasonable attorney’s fees and expenses, which are brought by a third party against the Indemnified Party to the extent they arise from the Indemnifying Party’s (a) breach of any provision of these General Terms; (b) negligence or willful misconduct; or (c) violation of any Applicable Laws; (d) with respect to Customer as the indemnifying Party, any death, bodily injury or property damage caused by Customer; or (e) with respect to Otsuka ICU Medical as the indemnifying Party, Otsuka ICU Medical’s Products causing death, bodily injury, or property damage, provided that such Products, were used in accordance with the respective Product Documentation.
11.2. TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, A PARTY SHALL NOT BE LIABLE FOR ANY LOST PROFITS, LOSS OF USE, BUSINESS INTERRUPTION, LOSS OF DATA, COST OF COVER OR INDIRECT, SPECIAL, INCIDENTAL, PUNITIVE OR CONSEQUENTIAL DAMAGES OF ANY KIND ARISING OUT OF THE GENERAL TERMS, WHETHER IN CONTRACT OR TORT, INCLUDING NEGLIGENCE, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. OTSUKA ICU MEDICAL’S AGGREGATE LIABILITY HEREUNDER SHALL BE LIMITED TO THE TOTAL OF ALL SUMS PAID BY CUSTOMER TO OTSUKA ICU MEDICAL UNDER THESE GENERAL TERMS AT THE TIME OF THE EVENT OR EVENTS GIVING RISE TO THE CLAIM(S).
12. Confidentiality
12.1. Each party agrees: (a) to keep confidential all Confidential Information disclosed to it by the other party; (b) not to use the Confidential Information of the other party except to the extent necessary for the purposes of these General Terms; and (c) to protect the confidentiality of the other party’s Confidential Information in the same manner as it protects the confidentiality of its own Confidential Information. For purposes of these General Terms, Confidential Information includes any non-public technical or business information of either party, including any information relating to a party's techniques, algorithms, knowhow, research, engineering, designs, financial information including pricing, customer lists, business forecasts, marketing plans, trade secrets and information or any materials marked confidential. Confidential Information shall also include any discussions or documentation relating to potential future products, software, features, and/or services. The obligations contained in this section shall survive, and continue in effect after the termination of these General Terms.
13. Disclosure and Reporting of Discounts
13.1. The purchase price under these General Terms (including the value of any discounts, rebates, or other price concessions) are intended to reflect discounts or other reductions in price within the meaning of the discount exception to the federal anti-kickback statute 42 U.S.C. Section 1320a-7b(b)(3)(A). In addition, any value provided to the Customer under the warranties in these General Terms shall be provided in accordance with the provisions of the federal anti-kickback statute warranty safe harbor regulation (42 CFR Section 1001.952(g)). Customer shall properly report, including any amendments or adjustments required to such reporting, and appropriately reflect such discounted prices on cost reports or claims submitted to any state or federal program that provides reimbursement to Customer for the items to which the discount applies. Further, Customer shall retain invoices and other price documentation and make them available to federal or state officials upon request.
14. Price Adjustments
14.1 Product prices and fees are as set forth in each Otsuka ICU Medical offer or quote. All prices and fees are subject to increase at Otsuka ICU Medical’s sole discretion. Notwithstanding and in addition to the foregoing, to the extent applicable, Otsuka ICU Medical may increase prices and fees in the event that import, export or customs duties, tariffs or like charges levied on the purchase or sale of the Products (or any of the inputs thereto) (collectively, “Tariffs”) increase by more than five percent (5%) for at least ninety (90) days in any twelve-(12) month period; provided that the rate of any such increase in the prices or fees shall not exceed the rate of increase of such Tariff.
15. Miscellaneous
15.1. Force Majeure. If either party is prevented, hindered, or delayed in performing any of its obligations under these General Terms (other than an obligation to make payment) by a Force Majeure Event then the affected party’s obligations under these General Terms shall be suspended for so long as the Force Majeure Event continues and to the extent that the party is so prevented or delayed; as soon as reasonably possible after the commencement of the Force Majeure Event.
15.2. Compliance with Laws and Regulations. Each party represents and warrants that it shall comply with all Applicable Laws in the performance of its obligations hereunder.
15.3. Assignment. Neither party may assign these General Terms or its rights hereunder, in whole or in part, without prior written consent of the other party, which shall not be unreasonably withheld or delayed, provided that each party herewith consents to any assignment by the other party of its rights and obligations: (i) to any Affiliate; or (ii) incident to the transfer of a party’s business assets (in whole or in part), or (iii) in the event of a merger, consolidation, acquisition, creation of a joint venture, or internal restructuring of a party. These General Terms shall inure to the benefit of and be binding on the successors and permitted assigns of a party.
15.4. Modification. Subject to limitations of applicable law, Otsuka ICU Medical may, at any time, change or remove any of the terms and conditions of, or add new terms or conditions to these General Terms. If we make such a change, you agree that Otsuka ICU Medical may provide you with notice of the change by any reasonable method.
15.5. Third Party Beneficiaries. Nothing in these General Terms is intended to benefit any person other than the Customer and Otsuka ICU Medical.
15.6. Waiver. Any waiver of any of the provisions of these General Terms or of a party’s rights or remedies hereunder must be in writing to be effective. Failure, neglect or delay by a party to enforce the provisions of these General Terms will not be construed or deemed to be a continuing or further waiver of such party’s rights under these General Terms and will not in any way affect the validity of the whole or any part of these General Terms or prejudice the right to take subsequent action.
15.7. Severability. If any provision of these General Terms shall be deemed unlawful, void, or for any reason unenforceable, then that provision shall be deemed severable from these General Terms and shall not affect the validity and enforceability of any remaining provisions.
15.8. Governing Law. These General Terms shall be governed by and construed in accordance with the laws of the State of Texas without reference to its conflict of laws principles. The rights and obligations of the parties under these General Terms shall not be governed by the 1980 U.N. Convention on Contracts for the International Sale of Goods.
15.9. Authority. Customer represents and warrants that (a) if it is a legal entity, it is a corporate entity duly organized, validly existing and in good standing under the laws of the jurisdiction of its organization; (b) it has all requisite power and authority to execute, deliver and perform these General Terms; (c) these General Terms are a legal and valid obligation binding upon Customer and enforceable in accordance with its terms; and (d) the execution, delivery and performance of these General Terms by Customer has been duly authorized by all necessary corporate action and do not conflict with any agreement to which it is a party or by which it is bound, nor violate any applicable law or any order or award of any court or governmental body applicable to Customer.
15.10. Sole contract. These General Terms constitute the entire understanding and agreement between Otsuka ICU Medical and Customer concerning the subject matter hereof, and supersedes all prior negotiations, agreements and understandings between Otsuka ICU Medical and Customer, whether oral or in writing, concerning the subject matter hereof. No additional terms contained in any Customer purchase order, acknowledgment form, or other document of Customer shall be binding on Otsuka ICU Medical, except that Customer’s purchase order shall be binding solely with respect to quantities and pricing of incremental purchases of Products therein. For the avoidance of doubt any Customer purchase order related to such incremental purchases of Products therein will be governed by these General Terms.
15.11. Notices. Any notices, or other information given, made or delivered to either party hereunder shall be sufficient if personally delivered, mailed, or sent by electronic transmission to the address of such party set forth on the Purchase Order.
15.12. Publicity. A party shall not make any press or other public announcement in relation to its contractual relationship with the other party without the prior written consent of such other party, whose consent shall not be unreasonably withheld or delayed; provided that Otsuka ICU Medical shall be permitted to make a reasonable public announcement upon advance written notice to Customer and provided further that Otsuka ICU Medical deems while acting in good faith that such public announcement is necessary for Otsuka ICU Medical to comply with its securities and exchange laws and/or other similar regulations. Following the date of these General Terms and regardless of any dispute that may arise in the future, the parties agree that they will not disparage, criticize, or make statements which are negative, detrimental, or injurious to the other to any individual, entity or body.
Schedule 1
1. Definitions. The capitalized terms used herein are defined as follows:
a. “Affiliate” means, with respect to a party, any current and future business entity that directly controls, is controlled by, or is under common control of such party. As utilized herein, "control" shall mean possession, direct or indirect, of the powers to direct or cause the direction of the management and policies of an entity through ownership.
b. “Applicable Laws” means all applicable federal, state and local laws, rules and regulations in the performance of a party’s obligations hereunder.
c. “Customer” means the party purchasing the Products hereunder and is defined on the Purchase Order.
d. “Force Majeure Event” means any event or cause beyond a party’s reasonable control, such as but not limited to, strikes, fires, explosion, flood, injunction, disruption of transportation infrastructure, public health emergency, epidemics, pandemics, accidents, market-wide inability to obtain supplies at reasonable prices, market-wide shortages including shortage of raw materials, war, act of governmental authority, terrorism, and acts of God.
e. “IV Solutions” means intravenous, irrigation, and nutritional solutions, applicable only if purchased under these General Terms.
f. “Orders” means any order with a value of $250.00 minimum, placed by the Customer under, and subject to, these General Terms.
g. “Products” means IV Solutions, including Rio.
h. “Product Documentation” means the product instructions for use, package inserts, product labelling, product packaging, manuals, specifications and training materials, which may include eLearning (including pre-recorded videos) if available, for any Product.
i. “Rio” – means Rio™ Drug Reconstitution Transfer Device, which is individual single-sterile and single use, applicable only if purchased under these General Terms.