ISO 13485:2016

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INSTALLATION PROJECTS TERMS AND CONDITIONS

    1. CONSTRUCTION WORK: There are no provisions made in this agreement for any construction, demolition or repair work that might be required to install the Equipment into its new location.
    2. CLEAR PATH FOR ENTRY/REMOVAL: BUYER is responsible for providing a clear path for the entry and/or removal of the equipment. This quote assumes the equipment is located on the ground floor near an open exit area, easily accessible to the street. Any extraordinary costs associated with moving the equipment in or out of the vault/facility, including but not limited to, floor shoring or support, construction, crane rental and operation, building of ramps to the outside or union labor requirements, are not included in the quoted price.
    3. SITE ACCESS: BUYER agrees to allow SELLER access to the site to perform work during operating hours of 8:00AM—10:00PM local standard time. Any restrictions to site access should be communicated prior to the start of the project. Additional time required to complete the project due to restricted hours of access may be subject to additional charges.
    4. INSTALLATION TIME LIMIT 18 MONTHS:  Buyer agrees to allow seller access to the installation site, to provide seller with the necessary support and resources to install the equipment, and to work in good faith with seller on scheduling so that the equipment is installed and accepted no later than 18 months after the execution of the agreement. Unless agreed upon by both parties in writing, in the event that the BUYER fails or refused to provide a room that is ready to accept delivery and installation of equipment within 18 months after the execution of this agreement, then (a) the rigging, installation and warranty provisions of this agreement will be cancelled, (b) any remaining amount due from BUYER shall be paid to SELLER, less a reduction of US$50,000 for installation services, © the terms of sale of the equipment will become “AS-IS, WHERE IS,” (d) BUYER will provide a location for the delivery of the equipment , or shall assume storage fees at SELLER’s storage facility of $1000/ month, subject to periodic increases, and (e) the transfer of title of the equipment will be issued to BUYER upon final payment.
    5. PAYMENT: Payments are to be made via certified check or wire transfer. The BUYER shall pay the price at the times and in the amounts set forth in the Quotation in full. Overdue invoices will bear interest at the rate of 18% per year. The BUYER will reimburse the SELLER for all costs of collection, including but not limited to attorney’s fees. If the BUYER does not pay an invoice issued on this Agreement or for any other item sold or service rendered by SELLER, or if at any time the BUYER indicates that it is unable or unwilling to pay an invoice, SELLER may suspend or terminate performance. The time for payment is of the essence of this contract.
    6. BUYER’S RESPONSIBILITIES: 
      1. Buyer will be required to ensure that the moving route and placement of the transport vehicle is clear installation of the machine.
      2. Buyer is responsible for ensuring that there is a clear path for the movement of Equipment into the room or vault.
      3. Buyer is responsible for ensuring that the room or vault is prepared and ready for the installation of the Equipment. Any delays resulting from failure of the Buyer to have the room prepared will be billed to the Buyer as an additional cost.
      4. BUYER shall be responsible for any construction, demolition, or repair work that may be required to install Equipment.
      5. Any union labor that is required will be charged for in addition to the cost of this agreement.
      6. Buyer shall provide all necessary electrical power to the machine, and provide all needed electrical breaker boxes, and qualified contractors to complete electrical hook up to the Equipment.
      7. Buyer shall be responsible for all necessary water, air, and plumbing hook ups.
      8. If any special work of any type must be performed or is required in order to comply with the requirements of any governmental authority, including procurement of special certificates, the same shall be performed and/or procured by the Buyer at Buyer’s expense.
      9. Buyer is responsible for any software modifications, upgrades, or licenses.
      10.  Buyer is responsible for all vault design, construction, shielding, architectural, electrical, mechanical and physics support. Buyer is encouraged to seek the advice of professional architects, physicists, vault construction specialists and/or any other contractors needed in the building or the modification of the vault. Seller is not responsible for any design or construction issues. Buyer is responsible to ensure that the design, shielding and construction conform to all local, state and federal requirements.
      11. Buyer is responsible for providing and installing water chiller, power conditioner and air compressor, if required.
      12. Buyer must secure all necessary software licenses from OEM.
      13. Buyer is responsible for training its staff on the operation of the Equipment.
      14. BUYER is responsible, as the future owner and operator of the Equipment, to contact the original manufacturer of the Equipment, if needed, in order to solicit information that may be necessary for the clinical installation and operation of the Equipment, including, but not limited to, software registration, passwords, and regulatory (FDA) listing information.
    7. SYSTEM AVAILABILITY: Availability date of Equipment is indicated on Page 1 and is an estimate based on the information provided to SELLER by the facility currently housing the Equipment. If the availability of Equipment is delayed beyond 60 days from the estimated removal date, then Buyer may have the option of renegotiating or canceling this agreement.
    8. TITLE: Upon payment in full, title shall pass to BUYER. SELLER certifies that the Equipment is free and clear of any encumbrances not caused by BUYER. Title will remain with SELLER or facility/owner until full payment has been made. It is recommended that BUYER retain appropriate insurance for Equipment after assuming title of Equipment.
    9. THIRD PARTY PRODUCTS: To the extent that add-on products and accessories (“third party products”) are included in this Agreement such products shall be subject to the standard agreements of the third party supplier and the BUYER agrees to execute and deliver to SELLER all agreements required by the third party supplier. The BUYER acknowledges that SELLER is not authorized to modify, amend, or supplement, and has not modified, amended, or supplemented, any term or condition of Third Party Supplier’s standard agreement. SELLER shall use its reasonable efforts to assist the BUYER in obtaining warranties, maintenance and support from Third Party Suppliers, provided, however, that in the event such Third Party Suppliers fail to warrant, maintain or support such Third Party Products, SELLER shall have no responsibility or liability by reason of such failure. BUYER acknowledges and agrees that SELLER is not the manufacturer or supplier of the third party products. SELLER assumes no responsibility for the delivery timeline, performance, or use of such third party products. SELLER, not being the manufacturer or supplier of the third party products, has not made and does not make any representation, warranty or covenant, expressed or implied with respect to the design, condition, durability, suitability, non-infringement, fitness for use, merchantability or satisfactory quality of third party products in any respect.As per SELLER and BUYER, the third party products shall be accepted and purchased or licensed by BUYER “as-is” and without warranty by SELLER. BUYER agrees to settle all claims directly with the appropriate third party supplier and will not assert any such claims against SELLER, or any affiliates of SELLER.
    10. TAXES: All sales and use taxes are BUYER’’s responsibility. Unless the sale is executed in California, the invoices from SELLER do not include local, state and federal taxes, and such taxes are the BUYER’s responsibility to file. Consequently, in addition to the prices specified herein, the amount of any present or future sales, use, or similar tax application to the installation of Equipment herein or to the use of such Equipment by the BUYER shall be paid by the BUYER or, in lieu thereof, the BUYER shall provide SELLER with a tax exemption certificate acceptable to the taxing authorities. The BUYER shall defend, indemnify and save the SELLER harmless from and against any sales, use or excise taxes of any kind or nature asserted by any jurisdiction for the Equipment and services that are the subject of this Agreement.
    11. PRIOR SALE: Equipment shall be subject to prior sale and this Agreement shall in no way be binding upon SELLER until the required deposit and signed Purchase Agreement are received and accepted. Acceptance is defined as being signed by all parties. Should Equipment become unavailable to SELLER for any reason, SELLER shall promptly refund all deposits. SELLER shall have no other liability if this should occur and this agreement shall be canceled.
    12. SUBCONTRACTORS: SELLER shall be entitled to appoint subcontractors or any other third parties for the performance or fulfillment in whole or in part of SELLER’s obligations under this Agreement without the consent of the BUYER, and SELLER shall be fully responsible and liable for the performance of any such entities. Seller may assign specific rights and duties under this Agreement to third parties.
    13. NON-CIRCUMVENTION: BUYER may inspect the Equipment if it is still in clinical use by a facility operating Equipment. Buyer agrees to limit any discussions during inspection or in the course of due diligence to technical and logistical issues, and further expressly agrees to NOT discuss any financial issues with the facility/owner. It is also agreed that any and all details specific to the Equipment, including but not limited to location, ownership, price, condition, etc. are confidential to SELLER, and that BUYER will not violate this confidentiality in any manner whatsoever. In the event BUYER declines the Equipment for any reason, BUYER agrees not to circumvent SELLER in the purchase of Equipment either directly or through any other agent, broker, affiliate, organization or entity. Should BUYER reject equipment, BUYER and/or BUYER’s agent(s) agree NOT to communicate with the facility/owner for any reason for a period of 180 days from the inspection date.
    14. COMPUTER SOFTWARE: Computer software (including, without limitation, source code, object code, application software, server and client software, operating system software, and software implemented as firmware) provided with the Equipment remains the property of the OEM (the original manufacturer of Equipment), or the OEM’s licensors and is subject to the OEM’s licensing terms and conditions. All software licensing and registration fees are the responsibility of the BUYER, including machine licensing and portal imaging licensing.
    15. TESTING: Upon completion of installation, the SELLER will perform tests on the equipment to determine whether it is operational. The SELLER may perform the tests in stages. The SELLER will notify the BUYER by telephone, email or facsimile of the date when it will begin testing so that the BUYER may attend. If the BUYER does not attend the testing in person or by sending a representative, the SELLER will conduct the tests in the BUYER’s absence, At the conclusion of the tests, the BUYER will sign the test results indicating acceptance and any objections. The SELLER will then remedy any substantial operational defects and re-test the pertinent parts or operations. When the defects are remedied, the BUYER will sign the test results indicating that all results were acceptable. Failure to attend the testing shall constitute the BUYER’S irrevocable acceptance of the Equipment. The BUYER will not run, operate or otherwise use the Equipment until the tests are completed and the BUYER signs a confirmation that it accepts the results. If the BUYER runs, operates or uses the Equipment before testing is completed, the BUYER shall be deemed to have irrevocably accepted the Equipment.
    16. STATE & FEDERAL COMPLIANCE: The BUYER is solely responsible for compliance with all state and federal requirements for shielding, licensing, installation and registration, as applicable.
    17. INDEMNITY: BUYER hereby agrees to hold harmless SELLER and its respective officers, employees, agents, representatives, and their respective successors and assigns from and against any and all loss, liability, damages, claims, causes of action, costs, and expenses, including but not limited to attorney’s fees and any other types of liability, whether accrued, absolute, contingent or otherwise, arising out of or related to use of any of the Equipment at any time. BUYER alone is responsible for costs required to comply with all requirements imposed by law or regulation relating in any way to personal safety prior to use or operation of Equipment.
    18. LIMITATION OF LIABILITY AND REMEDIES: THE TOTAL LIABILITY OF SELLER TO THE BUYER WILL NOT UNDER ANY CIRCUMSTANCES EXCEED THE PRICE OF THE INSTALLATION SERVICES. SELLER SHALL NOT BEAR ANY LIABILITY FOR LOSS OF REVENUE OR INCOME, DOWNTIME , ADDITIONAL EXPENSES, OTHER EXPENSE OR CONSEQUENTIAL, INCIDENTAL, LIQUIDATED, PUNITIVE, OR CONTINGENTS DAMAGES, INCLUDING BUT NOT LIMITED TO DAMAGE FOR PERSONAL INJURY OR PROPERTY DAMAGE BASED ON BREACH OF CONTRACT, BREACH OF WARRANTY, NEGLIGENCE , GROSS NEGLIGENCE, STRICT LIABILITY, PRODUCTS LIABILITY OR ANY OTHER THEORY OF LAW OR EQUITY. THESE LIMITATIONS AND EXCLUSIONS APPLY REGARDLESS OF WHETHER LIABILITY IS BASED ON THE NEGLIGENCE OR GROSS NEGLIGENCE OF THE SELLER OR OTHERS. BUYER ACKNOWLEDGES THAT THESE LIMITATIONS ARE MATERIAL PARTS OF THE BARGAIN AND THAT PRICES WOULD BE SIGNIFICANTLY HIGHER WITHOUT THEM.
    19. NON-WAIVER: No failure or delay by SELLER in exercising any right under this Agreement shall constitute a waiver of such right or of any other rights afforded the SELLER in this Agreement.
    20. COUNTERPARTS AND FACSIMILE SIGNATURES: This Agreement may be executed in any number of counterparts, each of which shall be deemed an original, but all of which taken together shall constitute one and the same Agreement. For purposes of this Agreement, signatures sent via facsimile or scanned email copies shall be deemed originals and shall have the same force and effect as if they were originals. This agreement shall not take effect until it is signed and delivered by all the Parties.
    21. DELAYS: Installation dates are estimates only. SELLER shall bear no liability for late shipment or installation.
    22. CONFIDENTIALITY: THE TERMS AND CONDITIONS OF THIS AGREEMENT ARE CONFIDENTIAL AND SHALL NOT BE DISCLOSED EXCEPT AS NECESSARY TO THE PERFORMANCE OF THIS AGREEMENT OR AS REQUIRED BY LAW.
    23. LICENSES, FEES, PERMITS: BUYER shall, at its own expense, obtain all necessary licenses, fees, permits, etc., as required by local, state or federal law, for the purchase, site preparation, installation and operation of the EQUIPMENT. BUYER shall be bound by its obligations of payment under this Agreement regardless of its compliance with the foregoing requirements.
    24. GOVERNING LAW; JURISDICTION: This Agreement shall be governed, interpreted and construed in accordance with the laws of California and the laws of the United States of America. The provisions of the United Nations Convention on Contracts for the International Sale of Goods, and any conflict-of-laws provisions that would require application of another choice of law, are excluded.
    25. DISPUTE RESOLUTION: If any dispute relating to this Agreement arises between Client and Contractor a party may send written notice to the other party within thirty (30) days of discovering the dispute, outlining the nature and extent of the problem. Said statement will contain all written documentation and supporting documents germane to the dispute. Representatives of the parties will then arrange to meet to discuss the dispute. If the meeting does not occur within thirty (30) days of the receipt of the initial notice, or if the meeting between the parties does not sufficiently resolve the dispute, a party may request a meeting between the executive officers of Client and Contractor. These officers shall have thirty (30) days after the receipt of this second notice and request to resolve the dispute, after which time, or if no resolution of the dispute is reached within sixty (60) days of receipt of the initial notice, a party may pursue its remedies at law. The parties may extend these time periods by mutual written assent in furtherance of obtaining a mutually acceptable resolution, and in order to permit the parties’ officers to meet to obtain such resolution. If a resolution of the dispute is obtained through any means described herein, the parties shall reduce such resolution to writing and/or amend the Agreement to include the resolution. Regardless, before a party may commence any litigation against the other party, a separate thirty (30) days written notice of the dispute and intent to file a lawsuit shall be provided to the other party.
    26. NO THIRD PARTY BENEFICIARIES: Except as expressly stated in this Agreement, the SELLER and BUYER are the only beneficiaries of the terms of this agreement.
    27. HEADINGS: The section headings contained in this Agreement are inserted for reference purposes only and shall not affect in any way the meaning, construction or interpretation of this Agreement. Any reference to the masculine, feminine, or neuter gender shall be a reference to such other gender as is appropriate. References to the singular shall include the plural and vice versa.
    28. NOTICE: Notices or other communications under this Agreement shall be in writing and deemed served if delivered personally, by overnight courier, or five (5) days after being mailed, postage prepaid, certified with return receipt requested, and addressed as stated on the first page of this Agreement.
    29. ENTIRE AGREEMENT/AMENDMENTS: This Agreement constitutes the entire, final, complete and exclusive statement of the terms and conditions of the agreement between SELLER and BUYER and supersedes all prior and contemporaneous understandings or agreements with respect to the same subject matter. No prior proposals, statements, representations or course of dealing, whether written or oral, will be part of this Agreement. No party has been induced to enter into this Agreement by, nor is any party relying on, any representations or warranty outside those expressly set forth in this Agreement. No amendment, addition or rescission of this Agreement shall be binding absent a written amendment or addendum signed by officers of the SELLER and the BUYER.
    30. SEVERABILITY: If any provision of this Agreement is deemed to be illegal, unenforceable, or invalid, in whole or in part, for any reason, the validity and enforceability of the remaining provisions, or portions of them, shall not be affected or impaired and shall continue in full force and effect.
    31. FORCE MAJEURE: Neither party shall be liable in damages and either party shall have the right to terminate this Agreement for any delay or default in performing hereunder if such delay or default is caused by conditions beyond its control including, but not limited to Acts of God, government restrictions (including the denial or cancellation of any licenses), wars, adverse weather conditions, insurrections and/or any other cause beyond the reasonable control of the party whose performance is affected.