TERMS AND CONDITIONS OF SALE
These Terms and Conditions for Sales of Products (these “Terms and Conditions”) constitute a binding legal agreement between Alamar Biosciences, Inc. (“Alamar”) and the purchaser (“End User”) or authorized distributor (“Distributor”), as applicable, identified on its order to Alamar for the products set forth below, unless other terms applicable to this sale are specifically agreed to by the parties in a written agreement signed by both parties. “Buyer” as used herein will refer to either End User and/or Distributor, as applicable. These Terms and Conditions govern the sale and license to the End User or Distributor by Alamar of the following types of products included in Buyer’s order (the “Products”):
- Alamar’s instrument, the ARGO, and
- Alamar’s consumables and reagents, including but not limited to NULISApcr and NULISAseq kits, as well as related ancillary products including detection kits, reagents, buffers, prep plates, cartridges and other consumables.
No Products sold under these Terms and Conditions may be used in patient diagnosis or patient management (outside of investigational use studies conducted in compliance with applicable law). Alamar’s acceptance of Buyer’s order is conditioned upon Buyer’s consent to these Terms and Conditions, and any additional or different terms, including those on Buyer’s order, are hereby rejected by Alamar. By placing an order, Buyer accepts and agrees to be bound by these Terms and Conditions. For Distributors, these Terms and Conditions are hereby incorporated into the International Distributor Agreement entered into by and between Alamar and Distributor, as may be amended from time to time (“Distributor Agreement”). To the extent that the terms and conditions set forth in these Terms and Conditions conflict with the terms of the Distributor Agreement, the terms set forth in these Terms and Conditions will govern. Fulfillment of Buyer’s order does not constitute acceptance of any of Buyer’s terms and conditions and does not serve to modify these Terms and Conditions.
1. Price. Unless otherwise stated on the face of the attached quote, prices exclude all insurance, freight, taxes, fees, tariffs, duties, and levies.
2. Delivery. Products will be packed in Alamar’s standard shipping packages. Alamar may make partial deliveries. Shipping and delivery dates provided by Alamar are approximate and are based upon prompt receipt of all necessary payment and information. Any delivery date, “ship no later than” date, “required by” date, etc., specified on a purchase order by Buyer will be of no force and effect. Alamar will not be liable for failure to ship Products in connection with a Force Majeure event (as defined below), including inability to obtain labor or other materials or other product delays, in which case Alamar may postpone delivery or shipment at its option without liability.
a. For End Users: Unless otherwise set forth in writing by Alamar or otherwise agreed by the parties, all shipments that are being made within the United States are FOB site of origin, and (ii) all shipments to destinations outside of the United States are made EXW (Incoterms 2010) Alamar’s manufacturing facility, except for shipments to member countries of the European Union, the United Kingdom, and Canada, which are made DDP (Incoterms 2010) excluding VAT. Alamar will ship via carrier selected by Alamar. In all cases, title to the Products (except for software, in which case Alamar shall retain title) and risk of loss shall pass to Buyer on delivery to the carrier. A reasonable fee will be added to the invoice and paid by Buyer to cover shipping and handling. Alamar is not responsible for damage caused in transit. It is the responsibility of Buyer to file damage claims directly with the freight company. If errors or shortages are detected in any shipment, Buyer must notify Alamar within three (3) business days of receipt.
b. For Distributors: Unless otherwise set forth in writing by Alamar or otherwise agreed by the parties, all shipments are made EXW (Incoterms 2010) Alamar’s manufacturing location or Alamar’s authorized logistics or warehouse location, for pick up by Distributor’s carrier of choice. Title (except for software in which case Alamar shall retain title) to the Products and risk of loss shall pass to Distributor on delivery to the carrier. Alamar shall use reasonable efforts to present the Products for pick up on the date agreed upon by Distributor and Alamar. All freight, insurance, and other shipping expenses, import and export fees and costs, as well as any special packing expense, shall be paid by Distributor.
3. Cancellation. Buyer may not cancel any custom FlexPlex order once Alamar has accepted Buyer’s target list (the “target acceptance date”). Buyer will be responsible for, and immediately pay, any fees incurred by Alamar or payments owed by Buyer with respect to Buyer’s order in the case of a cancellation after the target acceptance date.
4. Payment. Buyer will be invoiced at the time of shipment of each Product. Buyer shall make payment in full within thirty (30) days of the date of the invoice. Late payments may incur a charge at the rate of one percent (1.0%) per month, or the maximum allowed by law, whichever is less. Further shipment of Products may be declined without advance notice if Buyer fails to make any payment when due, or if the financial condition of Buyer becomes unsatisfactory to Alamar. Alamar may require payment on an irrevocable letter of credit reasonably acceptable to Alamar.
5. Limited Warranty.
- For the ARGO, as well as ancillary equipment, Alamar warrants that the instrument will conform in all material respects to Alamar’s published specifications in the product data sheets supplied by Alamar to Buyer for a period of 12 months after its shipment date from Alamar, unless the instrument includes Alamar-provided installation, in which case the warranty period begins on the date of installation or 30 days after the date it was delivered, whichever occurs first. Alamar’s sole and exclusive liability under the foregoing warranty shall be to repair or replace the instrument at no cost or provide Buyer a refund, as solely determined by Alamar. Nonconforming instruments will be serviced at Buyer’s facility or, at Alamar’s option, Alamar’s facility. If warranty service is performed at Alamar’s facility, Alamar will bear shipping costs. Except as provided above, this warranty does not apply to any defect caused by Third Party Software (as defined below) or to any Replacement Parts (as defined below). Alamar warrants that Replacement Parts will conform to their specifications for a period of 90 days from the date the Replacement Parts are installed. Replacement Parts do not extend the warranty for the underlying instrument. “Replacement Parts” means Alamar provided components, modifications, or enhancements to an instrument that was previously acquired by Buyer.
- For NULISA capture and detection kits (panel and custom), reagents, and consumables, Alamar warrants the kits, reagents, and consumables will conform in all material respects to Alamar’s published specifications in the product data sheets supplied by Alamar to Buyer until the end of the shelf life pre-printed on such Products by Alamar. For expiration dates that are listed with only a month and a year, the expiry date is the last day of the month indicated (e.g., for a Product printed with 2018-01, the expiry date 31 Jan 2018). Kits, reagents, and consumables reasonably determined by Alamar after investigation to be defective, independent of user error, shall be replaced by Alamar on a 1:1, like-kind basis at no cost to Buyer provided that such defective kits, reagents, and consumables were used by Buyer prior to their expiration date or shelf life date pre-printed on such Products.
- In order to be eligible for repair, replacement, or refund, as applicable, under these warranties, Buyer must (i) promptly contact Alamar’s technical support department to report the non-conformance, (ii) cooperate with Alamar in confirming or diagnosing the non-conformance, and (iii) return the Product, transportation charges prepaid to Alamar following Alamar’s instructions or, if agreed by Alamar and Buyer, grant Alamar’s authorized repair personnel access to the Product in order to confirm the non-conformance and make repairs.
- The foregoing warranties do not apply to the extent a defect or non-conformance is due to (i) misuse, neglect, negligence, accident, improper storage, or use contrary to the documentation or specifications, (ii) improper handling or maintenance, (iii) unauthorized alterations, (iv) a Force Majeure event, or (v) use with a third party’s goods not provided by Alamar (unless the Product’s documentation or specifications expressly state such third party’s goods are for use with the Product). The foregoing warranties apply only to Buyer, and not third parties, and only to Alamar-branded Products.
- The foregoing warranties shall be Buyer’s sole and exclusive remedy for non-conforming or defective Products. TO THE EXTENT PERMITTED BY APPLICABLE LAW, ALAMAR AND ITS SUPPLIERS DISCLAIM ALL OTHER REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO PRODUCTS, INCLUDING BUT NOT LIMITED TO, ANY IMPLIED WARRANTIES OF MERCHANTABILITY, SATISFACTORY QUALITY, NON-INFRINGEMENT, TITLE, OR FITNESS FOR A PARTICULAR PURPOSE.
6. Limited Software License; Intellectual Property. Notwithstanding anything to the contrary, including references to “sale” of any Product, the software (including any updates thereto provided by Alamar) is licensed, not sold. Subject to these Terms and Conditions, and to the terms and conditions of any license provided by Alamar that is specific to a particular Product (which shall govern with respect to such Product in the event of conflict with these Terms and Conditions), Alamar hereby grants to Buyer a limited, non-exclusive, non-transferable, non-sublicensable license to use any software or firmware provided as part of the Product(s), if any, only in accordance with the manuals and written instructions provided by Alamar and only as part of the Product and not on a stand-alone basis. For avoidance of doubt, the license to the software provided as part of a Product is not transferable and End User agrees to not sell, rent, lease, loan, transfer or assign or otherwise dispose of any Product or component thereof containing any such software to any third party unless End User first erases or removes the software or otherwise has the written consent of Alamar to transfer such Product with the software. The Products may be distributed with or contain or use certain open source or other third party software that may be covered by the terms of a different license (“Third Party Software”). Third Party Software is subject to and governed by (and licensee agrees to, and will indemnify Alamar for noncompliance with) the respective licenses for such Third Party Software. The notices, license terms, and disclaimers applicable to Third Party Software are contained in the user manual supplement for each instrument. Buyer further acknowledges that use of data analysis software, if purchased separately, requires connectivity with and use of Alamar’s Informatics Platform for data storage, analysis, and other applications related to the ARGOI instrument. Accordingly, Buyer acknowledges its responsibility for maintaining a subscription to the Alamar Informatics Platform to be able to use that platform. The terms and conditions with respect to the Buyer’s access to and use of the Alamar Informatics Platform are separately covered at [https://Alamar.com/about-us/legal/terms-of-sale].
7. Products Marketed and Labeled for Research Use Only. Products that are labeled For Research Use Only (“RUO”) do not have the approval or clearance of the U.S. Food and Drug Administration (“FDA”) or other global regulatory approval, clearance, or registration for in vitro diagnostic (“IVD”) use and are not for use in diagnostic procedures. No license is conveyed or implied for Buyer to use, and Buyer agrees not to use Products labeled RUO in clinical diagnosis, patient management, or an investigational study involving patient treatment decisions, or in any manner requiring FDA or other global regulatory approval, clearance, or registration relating to IVD use.
8. Use Restrictions. End User agrees not to (a) resell any Alamar-supplied kit, consumable, or reagent, or (b) transfer, or distribute any Alamar-supplied kit, consumable, or reagent, directly or indirectly, to any third party for any purpose or use, except as otherwise approved by Alamar in writing. Buyer agrees not to use and agrees not to allow anyone else to use any Alamar-supplied consumable more than once, or dilute any Alamar-supplied reagent. In addition, Buyer agrees not to, nor authorize any third party to, engage in any of the following activities: (i) separate, extract, or isolate components of the Products, as applicable, (ii) subject the Products or components thereof to any analysis not expressly authorized by a Product’s documentation, or (iii) reverse engineer, disassemble, decompile, remove, redistribute, or repackage any software or firmware provided as part of the Product(s). Buyer further agrees that the contents of and methods of operation of the Products are proprietary to Alamar and that the Products contain or embody trade secrets of Alamar. Buyer understands and agrees that except as expressly set forth in these Terms and Conditions, no right or license to any patent or other intellectual property owned or licensable by Alamar is conveyed or implied by these Terms and Conditions or any Product. In particular, no right or license is conveyed or implied to use any Product provided hereunder in combination with a product not provided, licensed, or specifically recommended by Alamar for such use. Buyer shall be solely responsible for all claims, losses, demands, damages, and liabilities arising under or in connection with the design, development, marketing, and sale of a product developed by Buyer which (i) is based on or derived from Alamar’s Products, or (ii) results from any modification made by Buyer to any of Alamar’s Products, except to the extent such claims, losses, demands, damages, and liabilities are directly resulting from gross negligence or willful misconduct of Alamar or a design defect in a Alamar product.
9. Pre-Release Products. If any Product is a beta, technology access, early access, or other pre-commercial release version (“Pre-release Product”), then this section applies. To the extent that any provision in this section is in conflict with any other term or condition in these Terms and Conditions, this section shall supersede such other term(s) and condition(s) with respect to the Pre-release Product, but only to the extent necessary to resolve the conflict. Buyer acknowledges that the Pre-release Product is a pre-release version, does not represent final product from Alamar, and may contain defects, bugs, errors, and other problems that could cause system or other failures, sample loss, and data loss. Consequently, the Pre-release Product is provided to Buyer “as is”, and Alamar disclaims all warranties (including the limited warranty set forth above in these Term and Conditions) and all liability obligations to Buyer of any kind. Buyer acknowledges that Alamar has not promised or guaranteed to Buyer that Pre-release Product will be announced or made available to anyone in the future, that Alamar has no express or implied obligation to Buyer to announce or introduce the Pre-release Product and that Alamar may elect not to introduce a product similar to or compatible with the Pre-release Product. Accordingly, Buyer acknowledges that any research or development that Buyer performs using the Pre-release Product or any product associated with the Pre-release Product is done entirely at Buyer’s own risk.
10. Reporting of Discounts. Buyer shall comply with applicable provisions of 42 U.S.C. §1320a-7b(b)(3)(A) (the “anti-kickback law” discount exemption) and 42 C.F.R. 1001.952(h) (the discount safe harbor) by properly disclosing and appropriately reflecting all discounts, rebates and other reductions in price provided in connection with a purchase under these Terms and Conditions to representatives of Medicare, Medicaid, and other Federal health care programs (as defined in 42 U.S.C. § 1320a-7b(f)). Specifically, to the extent applicable and required by law, including, but not limited to, 42 U.S.C. 1320a-7b(b) and 42 C.F.R. 1001.952(h): (a) if Buyer reports its costs to a Federal health care program, Buyer will accurately reflect all discounts or other price reductions received hereunder, and (b) whether or not Buyer reports its costs to a Federal health care program, Buyer will retain this agreement and other documentation provided by Alamar pertaining to the discounts provided hereunder, and provide such documentation to authorized representatives of the U.S. Department of Health and Human Services or a state health care program on request.
11. Liability Limitation. NEITHER ALAMAR NOR ITS SUPPLIERS WILL HAVE ANY LIABILITY FOR ANY LOSS OF USE OR PROFITS, PROCUREMENT OF SUBSTITUTE GOODS OR ANY INDIRECT, CONSEQUENTIAL, INCIDENTAL, OR SPECIAL DAMAGES OF ANY KIND, HOWEVER CAUSED AND REGARDLESS OF FORM OF ACTION WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE), STRICT PRODUCT LIABILITY OR OTHERWISE, EVEN IF ALAMAR OR ITS SUPPLIERS HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. AS TO ANY LIABILITY NOT LEGALLY SUBJECT TO THE FOREGOING, EXCEPT TO THE EXTENT CAUSED BY ALAMAR’S WILLFUL MISCONDUCT, OR AS REQUIRED BY APPLICABLE LAW, ALAMAR’S AND ITS SUPPLIERS’ LIABILITY SHALL NOT EXCEED THE AMOUNT PAID BY BUYER TO ALAMAR FOR THE PRODUCTS UNDER THESE TERMS AND CONDITIONS IN THE PRIOR TWELVE (12) MONTHS. BUYER AND ITS END USERS ARE RESPONSIBLE FOR, AND ALAMAR AND ITS SUPPLIERS WILL BEAR NO LIABILITY FOR, ANY TREATMENT AND CARE THAT IS RECOMMENDED OR PROVIDED BASED ON THE DATA GENERATED FROM THE PRODUCTS OR THE RESULTS OF SUCH TREATMENT OR CARE. BUYER UNDERSTANDS THAT THE RISKS OF LOSS HEREUNDER ARE REFLECTED IN THE PRICE OF THE PRODUCTS AND THAT THESE TERMS WOULD HAVE BEEN DIFFERENT IF THERE HAD BEEN A DIFFERENT ALLOCATION OF RISK. THE LIMITED REMEDIES AND LIABILITY LIMITS IN THESE TERMS AND CONDITIONS WILL APPLY EVEN IF THEY CAUSE A PROVISION TO FAIL OF ITS ESSENTIAL PURPOSE.
12. Export Controls. Buyer acknowledges that the Products and related materials may be subject to export controls under the U.S. Export Administration Regulations and related U.S. laws. Buyer will (a) comply strictly with all legal requirements established under these controls, (b) cooperate fully with Alamar in any official or unofficial audit or inspection that relates to these controls and (c) not export, re-export, divert, transfer or disclose, directly or indirectly, any Product or related technical documents or materials or any direct product thereof to any country (or to any national or resident thereof) which the U.S. Government determines from time to time is a country (or end-user) to which such export, re-export, diversion, transfer or disclosure is restricted, without obtaining the prior written authorization of Alamar and the applicable U.S. Government agency.
13. Unforeseen Events. Alamar shall not be liable for delay or failure in performance of any obligations hereunder if performance is rendered impracticable by the occurrence of any condition beyond the reasonable control of Alamar (“Force Majeure”). In the event of any such delay or failure in performance, Alamar shall have such additional time within which to perform its obligations hereunder as may reasonably be necessary under the circumstances.
14. Miscellaneous. Both parties will perform their obligations under these Terms and Conditions in compliance with all applicable laws and regulations. These Terms and Conditions and Buyer’s order are governed by the laws of the State of California, USA, without reference to conflict of law principles. All disputes arising out of or related to these Terms and Conditions or Buyer’s order will be subject to the exclusive jurisdiction of the courts located in Alameda County, California and the parties agree and submit to the personal and exclusive jurisdiction and venue of these courts. Buyer will not assign this agreement, directly or indirectly, by operation of law or otherwise, without the prior written consent of Alamar other than to a successor entity to which the assigning party transfers or assigns all or substantially all of its assets. The U.N. Convention on Contracts for the International Sale of Goods shall not apply to these Terms and Conditions. These Terms and Conditions constitute the entire agreement between Buyer and Alamar with respect to the subject matter hereof and Buyer’s order, and are the final, complete, and exclusive statement of the terms of the parties’ agreement, superseding all other agreements, communications, and understandings with respect to the subject matter hereof. The waiver of any provision or any breach of a provision of these Terms and Conditions shall not affect any other provision herein.