® Immunoassay System Rental, Lease And Sales Terms & Conditions

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ERENNA ® IMMUNOASSAY SYSTEM RENTAL, LEASE AND SALES TERMS & CONDITIONS


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These ERENNA® IMMUNOASSAY SYSTEM RENTAL, LEASE AND SALES TERMS & CONDITIONS (“T&Cs”) are effective between Singulex, Inc., a Delaware corporation with a principal place of business at 1650 Harbor Bay Parkway, Suite 200, Alameda, CA 94502 ("Singulex"), and Customer upon execution of a Written Commitment (e.g., Purchase Order, Binding Quote, Rental Agreement, Lease Agreement, Sales Agreement, etc.) for the rental, lease or sale of a Singulex Erenna Immunoassay System (“Equipment”). Singulex and Customer are each a “Party” and, collectively, are “Parties” to the T&Cs.

WHEREAS, Singulex provides rental, lease or purchase of Equipment and purchase of reagents and consumable goods for use with Equipment such as reagent plate kits, system calibrators, systems buffers, Sgx micro-particles (MPs) with capture antibodies, Sgx Detection Antibodies, and the like (“Components”);

WHEREAS, Customer wishes to secure the use of Equipment through rental or lease or to purchase Equipment outright, as well as purchase Components, and Singulex is willing to provide Equipment and Components to Customer; and

NOW, THEREFORE, in consideration of the mutual promises and covenants hereinafter contained and of other good and valuable consideration, the receipt and sufficiency of which is acknowledged upon signing a Written Commitment, the Parties agree as follows:

  1. DELIVERIES AND INSPECTION

    Equipment and Components, delivered by Singulex shall be subject to prompt inspection at the ultimate destination.  All or any part of the order may be returned at Singulex's expense within ten (10) days after delivery if defects or damage are found or if the Equipment or Component is not in accordance with specification.  Acceptance of all or part of the goods, or payment therefor shall not waive nor affect the Customer’s right to return all or part of the goods if a breach of warranty is subsequently found to exist.  Singulex shall bear its cost of inspecting and testing of Equipment and Components that are rejected.

    Components may be returned during the warranty period in the event that damage or defects are found; provided, however, the Customer must use the same method of delivery for such return as Singulex used in delivering the Components.  Singulex shall be responsible for the costs of such return only if such damage or defect can be verified.


  2. TIME OF ESSENCE; CANCELLATION

    The Customer may refuse to accept, or may return at Singulex's expense, any goods ordered hereunder if Singulex fails to deliver the goods within the time specified (time being of the essence hereof).

  3. INTELLECTUAL PROPERTY

    The parties agree that intellectual property owned by Singulex prior to its entry into this sale, which includes but is not limited to intellectual property contained in the Equipment and the Components, shall remain the property of Singulex (“Pre-Existing Singulex IP”). Any inventions that arise out of the performance of services that are related to or are reasonably foreseeable as related to Pre-Existing Singulex IP shall be the sole and exclusive property of Singulex. Inventorship for all other inventions that arise during the course of use of the Erenna Immunoassay System will be determined in accordance with U.S. patent laws, including ownership of such inventions.

    The Customer will be the owner of all results generated by the Customer using the Equipment and/or the Components and may use and dispose of such results for any purpose in its sole discretion.
  4. FORCE MAJEURE

    Neither party shall be liable to the other for any failure to perform hereunder or for delay in performance when such failure or delay shall be caused (directly or indirectly) by fire; flood; accident; explosion; equipment or machinery breakdown; sabotage; strike or any labor disturbance; riot; invasion; war; any act of any governmental agency (whether or not valid): shortage of labor, fuel power or raw materials; inability to obtain or delays of transportation facilities; any Acts of God; or any other event beyond the reasonable control of the party whose performance is affected (each, an "Event of Force Majeure"). The party whose performance is so affected shall provide prompt notice to the other, shall indicate the estimated duration of such Event of Force Majeure and shall use all reasonable efforts to mitigate effects of such Event of Force Majeure. If, by reason of any such Event of Force Majeure, Singulex is excused from performance, then, to the extent goods are not delivered to the Customer, to the extent goods are not delivered to the Customer in the quantities or at the times required hereunder, the Customer may purchase the same or similar goods from other sources without liability or obligation to Singulex.

  5. COMPLIANCE WITH LAW

    Singulex represents that all goods will be produced, packaged, labeled, sold and delivered in accordance with all applicable federal, state or municipal laws, codes, regulations, rules, orders and binding requirements (collectively “Laws”), including but not limited, and to the extent applicable, the Fair Labor Standards Act of 1938. as amended; Title VII of the Civil Rights Act of 1964, as amended: the Occupational Safety and Health Act; Executive Order 11738; the Toxic Substances Control Act; the Food, Drug and Cosmetic Act, as amended; and all regulations promulgated under the foregoing. Singulex agrees to comply with all statutory, regulatory, and contractual requirements applicable to Singulex pursuant to the Customers’ prime contract(s) with the orders and billing requirements ("Applicable Requirements"). Specifically, Singulex represents that it will comply with Applicable Requirements of the following provisions of Federal law, which are hereby incorporated by reference in this Agreement (copies of which may be furnished upon request): (1) FAR [48 C.F.R.] 52.219-8, relating to small business subcontracting: (2) FAR 52.219-9, relating to small business subcontracting documentation and reporting requirements; (3) FAR 52.222-26 and 41 C.F.R. 60-1.4, relating to Equal Opportunity; (4) FAR 52.222-35 and 41 C.F.R. 60-250.5, relating to Affirmative Action for Disabled Veterans; and (5) FAR 5.222-36 and 41 C.F.R. 60-741.5, relating to Workers with Disabilities.

  6. SERVICES

    To the extent that Singulex is providing services to the Customer, either alone or in conjunction with the sale of goods, the following provisions apply in addition to the other applicable provisions. 
    (a) Any services performed hereunder are in Singulex's capacity as an independent contractor and Singulex shall be solely responsible for and have control over the means, methods, techniques, and sequences of the services. Neither Singulex nor its employees, agents, or representatives are employees of the Customer and Singulex retains the exclusive right to hire, discipline, evaluate, and terminate its own employees and to set their hours, wages and terms and conditions of employment.

    (b) Singulex shall, at its sole expense, obtain, keep in force, and comply with, any and all permits, licenses, qualifications and approvals (collectively, “Permits”) required under any applicable Laws with respect to the services provided to the Customer.

    (c) Singulex represents that it shall perform the services (i) in a professional manner; (ii) in conformance with that level of care and skills ordinarily exercised in similar circumstances by providers of the same or similar services; and (iii) in compliance with all applicable Laws and Permits and with the Customer’s site rules and regulations (to the extent they have been provided to Singulex). Singulex represents that it is presently free from any commitments or conflicts of interest that would impair Singulex from performing its obligations.

    (d) Singulex agrees that it shall maintain the following insurance in amounts no less than that specified for each type: (i) general ability insurance with combined limits of not less than $1,000,000 per occurrence and $1,000,000 per accident for bodily injury, including death, and property damage; (ii) workers' compensation insurance in the amount required by the law of the state(s) in which the Singulex’s workers are located and employer's liability insurance with limits of not less than $1,000,000 per occurrence; and (iii) in the event that use of a company-owned motor vehicle is required in the performance of this Agreement, automobile liability insurance with combined limits of not less than $1,000,000 per occurrence and $1,000,000 per accident for bodily injury, including death, and property damage. Upon request, Singulex shall provide the Customer with evidence of Singulex's insurance. Singulex will name The Customer as an additional insured party under Singulex’s insurance policy, and will provide to the Customer at least thirty (30) days prior written notice of any change to or cancellation of Singulex's insurance program. 

    (e) As a condition precedent to any payments, Singulex will furnish, upon request, a waiver or release of subcontractors' rights to file mechanic's liens against the work, materials, articles or equipment.

  7. PRICE AND PAYMENT TERMS

    The goods and/or services furnished hereunder shall be billed at the price last quoted to the Customer, or at the prevailing market price, whichever is less. Payment will be due net thirty (30) days of receipt of the invoice or the goods, whichever is later, unless in dispute.

  8. DELIVERY AND SHIPMENT

    Singulex will make every effort to ship the products or provide the services hereunder in accordance with the requested delivery date, provided that Singulex accepts no liability for any losses or for damages arising out of delays in delivery. Shipment of all products shall be F.O.B. point of distribution by Singulex; identification of the products shall occur when they leave Singulex's point of distribution, at which time title and risk of loss shall pass to Customer. All shipment costs shall be paid by Customer and if prepaid by Singulex, the amount thereof shall be reimbursed to Singulex.

    Products shipped with dry ice are subject to a handling charge, which is prepaid by Singulex and added to the invoice.

    At its election, Singulex may reserve a volume of certain Equipment and Components for evaluation on behalf of Customer, for up to 90 days. The reserved volume is subject to reallocation or release at Singulex's discretion. Customer is responsible for evaluation of reserved product and determination of specific volumes and delivery schedules to be requested. Within 90 days, Customer must provide Singulex with a Purchase Order detailing the product, lot, volume, and delivery schedule for reserved product. All excess product(s) will be released at Singulex's discretion. Should Customer be unable to determine a firm delivery schedule for a reserved product within 90 days, a separate written Supply Agreement detailing product, lot, volume, price, storage fees, and a final date when the balance of all products will be delivered must be agreed upon between Singulex and Customer before any product will be delivered. The final shipment date may not exceed 365 days after execution of the Supply Agreement. The Supply Agreement is subject to all terms and conditions set forth herein.

  9. TAXES

    The Customer shall be liable only for these taxes imposed on the Customer by operation of law. The Customer may require Singulex to provide the Customer with documentation satisfactory to the Customer establishing the Customer’s liability for such taxes; provided that Singulex shall not be required to provide such documentation in connection with sales or use taxes unless the Customer questions the applicability of such taxes.

  10. COMPONENTS

    The Customer agrees to source all its requirements for Components from Singulex for use with the Equipment, non-limiting examples comprising Reagent plate kits, System calibrators, Systems buffers, Sgx micro-particles (MPs) with capture antibodies, and Sgx Detection Antibodies.

  11. CUSTOM MADE-TO-ORDER PRODUCTS

    Singulex may define certain products as Custom. Customer must provide Singulex with product specifications prior to the start of manufacturing a Custom product. Singulex and Customer shall agree to all production and testing techniques prior to the start of manufacturing a Custom product. Customer must provide a Purchase Order detailing product and delivery schedule for reserved product. Customer shall purchase the entire lot of the Custom without regard to volume. Purchase Orders for a Custom product(s) are not cancelable.

  12. TITLE AND RISK OF LOSS

    Title and risk of loss to goods delivered hereunder will transfer to the Customer FOB Singulex (upon delivery by Singulex to the carrier).

  13. WARRANTIES:

    Singulex warrants to the Customer and its customers that the Equipment and Components to be delivered under this Agreement will be of merchantable quality, free from any latent or patent defects in design, materials or workmanship and will conform to specifications and descriptions, and will be safe for their intended use. NEITHER SINGULEX NOR THE CUSTOMER MAKES ANY REPRESENTATIONS OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING ANY EXPRESS OR IMPLIED WARRANTIES OF MERCHANTABILITY, TITLE OR FITNESS FOR A PARTICULAR PURPOSE OR FOR NON-INFRINGEMENT OF A PATENT, TRADEMARK OR OTHER INTELLECTUAL PROPERTY RIGHT. 

  14. AUTHORIZED USE

    The purchase of Singulex products conveys to Customer a non-transferable right to use the purchased product(s) in compliance with the intended use statement listed on the product data or product information that accompanies each product. Each product also may be accompanied by limited use information or limited use label licenses. Unless otherwise expressly stated in product data or product documentation sheets, Singulex products have not been tested for safety or efficacy.

    As stated in the documentation accompanying the Equipment and Components, certain Equipment and Components are intended for research use only and are not to be used for any other purpose, which includes but is not limited to, unauthorized commercial uses, in vitro diagnostic uses, ex vivo or in vivo therapeutic uses or any type of consumption or application to humans or animals.

  15. LIMITATION OF LIABILITY

    NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY INCIDENTAL, INDIRECT, CONSEQUENTIAL OR SPECIAL DAMAGES, INCLUDING LOSS OF PROFIT, ARISING OUT OF THIS AGREEMENT OR WITH RESPECT TO A PARTY’S PERFORMANCE OR NON-PERFORMANCE OF THIS AGREEMENT.

  16. F.D.A- GUARANTY

    Singulex guarantees that, no article herein is, as of the date of shipment adulterated or misbranded within the meaning of the federal Food, Drug and Cosmetic Act, as amended, or the regulations promulgated thereunder, or is an article which may not, under the provisions of Section 404, 405 or 512, of said Act, be introduced into interstate commerce.

  17. CONFIDENTIALITY:

    The parties shall hold in confidence and not use for itself or others any and all information disclosed to or developed by the other party in its performance hereunder.

  18. GOVERNING LAW

    This Agreement shall be governed by and construed in accordance with the laws of the state of California, without regard to principles of conflicts of law.

  19. NO ASSIGNMENT

    Orders are not assignable or transferable, in whole or in part, without the express written consent of Singulex.

  20. TYPOGRAPHICAL ERRORS

    Stenographical, clerical or computer errors on the face of any Singulex invoice shall be subject to correction by Singulex.

  21. ENTIRE AGREEMENT

    These Rental Lease and Sale Terms and Conditions, in conjunction with any Written Commitment, shall constitute the final, complete, and exclusive statement of the terms of the agreement between the parties pertaining to the sale of Singulex products and supersedes all prior and contemporaneous understandings or agreements of the parties.

Understood, Agreed & Approved

The Customer, in signing a Written Commitment, acknowledges that they have carefully reviewed these Terms and Conditions and agrees to and accept all of the Terms and Conditions herein.

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