Terms and Conditions of Sale
These Terms and Conditions of Sale ("Terms and Conditions") shall govern the sale and license to the purchaser ("Buyer") of probes, assays, reagents, instruments, software, and other products and related services ("Products") by Advanced Cell Diagnostics, Inc. ("ACD") named on the invoice or acknowledgement provided to Buyer in connection therewith. These Terms and Conditions shall replace and supersede any current or future purchase orders or similar forms that are not mutually signed by ACD and Buyer. Purchase orders, once accepted by ACD, are not subject to cancellation or modification by Buyer without ACD’s written consent.
Prices exclude all insurance, freight, taxes, fees, duties and levies, which shall be payable by Buyer.
ACD will ship via carrier selected by ACD. Delivery dates set forth on a purchase order accepted by ACD are subject to change and are predicated on conditions existing at that time. ACD does not guarantee any delivery dates and shall not be responsible for any loss or damage arising out of any delay in delivery irrespective of the cause of such delay. ACD may make partial deliveries. For Deliveries Outside US: Tender will be FCA our shipping point. Title (except for software in which case ACD shall retain title) and risk of loss or damage will pass to Buyer upon delivery of the Products to the carrier.
Any claims for damaged, missing or defective Product must be reported in writing to ACD by Buyer within five (5) days from the date of receipt of Product. For any valid claim made, ACD shall, at its sole discretion, either repair or replace the Product. The foregoing shall be Buyer’s sole and exclusive remedy for damaged or missing Products, and, except for express warranty rights, for defective Products.
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 and one-half percent (1.5%) percent 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 ACD. ACD may elect to retain a security interest in all Products sold to Buyer to secure all of Buyer’s obligations to ACD under these Terms and Conditions, and Buyer will execute any documents necessary to create and perfect this interest. Sales by ACD shipped outside the U.S. may require payment on an irrevocable letter of credit reasonably acceptable to ACD.
For new instruments that are not Pre-release Products (as defined below), ACD warrants to and only to Buyer for thirteen (13) months from the date of shipping or one (1) year from the date of installation (or for the period specified in the ACD sales quote for limited-life parts), whichever occurs first, that the software and instruments are free from defects in material and workmanship and conform to ACD’s published specifications in all material respects. For refurbished instruments that are not Pre-release Products, ACD warrants to and only to Buyer for ninety (90) days from the date of installation (or for the period specified in the ACD sales quote for limited-life parts) that the software and instruments are free from defects in material and workmanship and conform to ACD’s published specifications in all material respects. Service will be provided pursuant to ACD’s standard service terms and conditions. ACD’s sole and exclusive liability (and Buyer’s sole and exclusive remedy) under the foregoing warranty shall be to repair or replace software and instruments or provide Buyer a refund, as determined by ACD in its sole discretion. Nonconforming instruments will be serviced at Buyer’s facility or, at ACD’s option, ACD’s or its supplier’s facility. If service is performed at ACD’s or its supplier’s facility, ACD will bear shipping costs. For probes or reagents reasonably determined by ACD to be defective, independent of user error, shall be replaced by ACD on a 1:1, like-kind basis at no cost to Buyer provided that such defective probes or reagents were used by Buyer prior to their expiration date, or if there is no expiration date, the Products were used within six (6) months of receipt, and the defect was promptly reported with appropriate detail to ACD’s technical support.
ACD, may, in its own discretion, furnish technical assistance and information with respect to the Products. ACD is under no obligation to provide technical assistance or information about ACD products. Any suggestions by ACD regarding use, selection, application or suitability of the Products shall not be construed as a warranty.
Except as provided above, any warranty provided herein does not apply to other consumables, or to any defect caused by failure to provide a suitable storage, use, or operating environment, use of non-recommended reagents, spills, or the use of the Products for a purpose or in a manner other than that for which they were designed, modifications or repairs done by Buyer, or any other abuse, misuse, or neglect of the Products. This warranty applies only to Buyer, and not third parties. The foregoing is not intended to limit any warranty extended to Buyer by a third party original equipment manufacturer of a Product or component thereof, provided that any remedy received by Buyer under any such warranty shall relieve ACD of its obligations with respect to the subject of such remedy. TO THE EXTENT PERMITTED BY APPLICABLE LAW, ACD AND ITS SUPPLIERS DISCLAIM ALL OTHER REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO PRODUCTS AND SERVICES, INCLUDING BUT NOT LIMITED TO, ANY IMPLIED WARRANTIES OF MERCHANTABILITY, SATISFACTORY QUALITY, NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE
Pre-release Products (Not Applicable to Products Marketed for IVD Use)
If any Product is a beta, technology access, early access, or other precommercial 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 ACD, 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 YOU "AS IS", AND ACD DISCLAIMS ALL WARRANTIES (INCLUDING THE LIMITED WARRANTY SET FORTH ABOVE) AND ALL LIABILITY OBLIGATIONS TO BUYER OF ANY KIND. Buyer acknowledges that ACD has not promised or guaranteed to Buyer that Pre-release Product will be announced or made available to anyone in the future, that ACD has no express or implied obligation to Buyer to announce or introduce the Pre-release Product, and that ACD 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.
Products of ACD which are or may be drugs, food additives or diagnostic reagents, as described in the federal food, drug and cosmetic act, are for investigational use only in laboratory research animals or testing in vitro, and are not for drug, new drug, veterinary drug, food, food additive or human use. Unless otherwise indicated, all products are distributed and sold for chemical purposes only, not for drug use or for application to or ingestion by humans or for commercial horticulture use, for pesticide use, for application to or ingestion by animals or for veterinary drug use. All products sold by ACD to Buyer shall be used by qualified professionals only. The burden for safe use and handling of all products sold by ACD to Buyer is entirely the responsibility of Buyer and anyone who purchases the goods from Buyer and uses them. Absence of hazardous warnings does not imply nontoxicity.
ACD does not warrant that the use or sale of the products delivered hereunder will not infringe the claims of any United States or other patents covering the use thereof in combination with other products or in the operation of any process. Additionally, Customer is required to indemnify ACD from any legal action that may result from the synthesis of an ordered "By Request" product, or from Customer’s use of a product manufactured by ACD under this agreement.
Products Marketed for Research Use Only
Products marketed by ACD for research use only ("RUO") do not have the approval or clearance of the U.S. Food and Drug Administration ("FDA") or other regulatory approval, clearance or registration for in vitro diagnostic ("IVD") use. No license is conveyed or implied for Buyer to use, and Buyer agrees not to use, such Products in any manner requiring FDA or other regulatory approval, clearance or registration relating to IVD use. Because ACD’s goods that are intended for research purposes may not be on the Toxic Substances Control Act ("TSCA") inventory. Buyer assumes responsibility to ensure that the goods purchased from ACD are approved under TSCA, if applicable. Consistent with Buyer’s agreement to comply with all TSCA and Research and Development substance exemption (the "R&D exemption") requirements applicable to the purchase, Buyer agrees and warrants that Buyer will comply with all the requirements necessary to maintain the R&D exemption, including using the R&D substance under the supervision of a technically qualified individual, maintaining all necessary labeling, and providing all necessary notifications. Buyer also agrees and warrants that Buyer will use or sell (if otherwise so authorized) the R&D substance exclusively for R&D purposes or specified exempt commercial purposes. Buyer specifically agrees and warrants that Buyer will not sell or distribute the R&D substance to consumers.
Products Marketed for In Vitro Diagnostic Use
Products marketed by ACD for IVD use have been cleared by the FDA, and CE marked in the European Union, for IVD use. No license is conveyed or implied for Buyer to use, and Buyer agrees not to use, such Products in any manner requiring other regulatory approval, clearance or registration relating to IVD use.
Buyer is not licensed to, and agrees not to: (a) resell any ACD-supplied probes or reagent, (b) transfer, or distribute any ACD-supplied probe or reagent, directly or indirectly, to any third party for any purpose or use, except as otherwise approved by ACD in writing; (c) use or allow anyone to use any ACD-supplied probe or reagent more than once, or dilute any ACD-supplied reagent unless instructed to do so in the User Manual of the product; or (d) provide a fee-for-service or other non-collaborative sample processing service to third parties using an ACD-supplied probe or reagent (e.g., wherein the service provider offers standardized services for standardized fees to multiple third parties, the customer does not contribute scientifically to the services performed, and all rights to the results and discoveries derived therefrom are transferred to the customer).
Except to the extent prohibited by applicable law, Buyer hereby grants to ACD a non-exclusive, worldwide, fully sublicensable, fully paid-up, royalty-free, irrevocable, perpetual license to all Product Improvements. Buyer need not disclose any Product Improvements to ACD except as may be reasonably required to comply with the foregoing license. For purposes of this Section, a "Product Improvement" shall mean any invention conceived or reduced to practice using a Product that relates to (a) design, manufacturing, layout or packaging of nucleic acid probes; (b) manual or automated assay techniques that may be used in connection with probes, reagents or similar products.. "Product Improvements" shall not include data generated using Products or discoveries derived therefrom (except as expressly set forth in (a) – (b) above).
Target Probe List and New Target Probes
ACD publishes and, from time to time, updates its list of "readily available" target probes (the "Target Probe List"). Upon request, ACD will provide pricing information for target probes that are not currently in the Target Probe List. If ACD designs or develops a new target probe upon specific request of a customer, ACD will retain the right to commercialize that target probe, and may add it to its Target Probe List; provided, however, that ACD will not disclose the association between the identity of the buyer of such target probe, and the target of interest.
Target Sequence Responsibility
Buyer shall be fully responsible for the Target sequences, including the obtaining of all required consents, and Buyer agrees to indemnify ACD and its employees, officers, directors, representatives, contractors, suppliers and any affiliate of the foregoing (the "ACD Group") and hold each of them harmless from and against any losses, liabilities, demands, damages, costs and expenses, including without limitation reasonable legal fees and expenses, arising from or relating to the Target Sequences or their use. Buyer agrees to fully cooperate with the ACD Group and its counsel in its defense and preparation for any such action or proceeding.
EXCEPT TO THE EXTENT CAUSED BY ACD’s GROSS NEGLIGENCE OR WILLFUL MISCONDUCT, OR REQUIRED BY APPLICABLE LAW, ACD SHALL HAVE NO 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 ACD HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. ACD’s AGGREGATE LIABILITY SHALL NOT EXCEED THE AMOUNT PAID BY BUYER TO ACD FOR THE PRODUCTS. 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
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 ACD 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 ACD and the applicable U.S. Government agency.
Each party shall be and act as independent contractor and not as partner, employee, joint venturer, or agent of the other and shall not bind nor attempt to bind the other to any contract. Buyer may not assign its rights or obligations under this Agreement without the consent of ACD. ACD may assign its rights and obligations hereunder without consent to an affiliate or to a successor to all or substantially all of ACD’s business or assets. The failure of either party to enforce its rights under this Agreement at any time for any period shall not be construed as a waiver of such rights. In the event that any provision of this Agreement shall be determined to be illegal or unenforceable, that provision will be limited or eliminated to the minimum extent necessary so that this Agreement shall otherwise remain in full force and effect and enforceable. This Agreement shall be governed by and construed in accordance with the laws of the State of California (without regard to the conflicts of laws provisions thereof or the UN Convention on the International Sale of Goods). The sole jurisdiction and venue for actions related to the subject matter hereof shall be the state and federal courts located in California (provided that ACD may elect, at its option, to bring action in the courts for the location of Buyer’s principal office) and Buyer consents to the jurisdiction of such courts with respect to any such action. In any action or proceeding arising out of this Agreement, the prevailing party will be entitled to recover costs and attorneys’ fees.