Below are the customer Account Terms and Conditions. For additional terms please see:
- General Pricing and Fee Policies
- Protocol & Regulatory terms and conditions
- Service Guide (PDF)
- Controlled Substance Information
- Website Use terms and conditions (www.nelsonlabs.com)
For an account with Nelson Laboratories, LLC (“Nelson”) for laboratory and consulting services and in consideration hereof, the Customer hereby accepts and agrees (the “Agreement”) to all of the Account Terms and Conditions attached hereto and incorporated herein by reference as if fully set forth herein. The Customer acknowledges that they have read and understand all of the Account Terms and Conditions and agrees that the Account Terms and Conditions shall supersede any terms and/ or conditions that may be proposed in the Customer’s purchase orders or otherwise. The Customer agrees that the Account Terms and Conditions shall control all transactions conducted between Nelson and the Customer.
Account Terms and Conditions
The following Account Terms and Conditions apply to all transactions for laboratory testing and consulting services between customer and (as defined in the Account Credit Agreement and Account Terms and Conditions Agreement) Nelson Laboratories, LLC (“Nelson”) unless otherwise specified in writing by an officer of Nelson:
- Contract Agreement/Terms and Conditions: The Customer agrees that when placing an order with Nelson, that Nelson’s final price quotation as set forth below or formal project estimate, these Account Terms and Conditions, the Customer’s purchase order (not including any terms and/or conditions that may be contained in the Customer’s purchase order), and Nelson’s confirmation to perform services shall constitute the entire contract between the Customer and Nelson (the “Agreement”). A purchase order issued to Nelson shall not constitute a binding contract unless and until it is accepted and acknowledged by Nelson. The Customer accepts and agrees to all of Nelson’s Account Terms and Conditions in lieu of the Customer’s terms and conditions (even if terms and conditions are contained in the Customer’s purchase order) on all orders placed with Nelson unless otherwise agreed to in writing by both parties. Orders submitted without a quotation or formal project estimate shall be subject to Nelson’s pricing then in effect and published on Nelson’s website (www.nelsonlabs.com) or, if not so published, Nelson’s default pricing for the current year.
- Credit Terms and Payment: Any credit granted to the Customer by Nelson is at the sole discretion of Nelson and Nelson may cancel, reduce or refuse to extend additional credit at any time, with or without cause of any kind. The acceptance of any purchase order by Nelson shall be conditioned upon approval of the Customer’s credit or payment in advance for Nelson’s services. The Customer agrees that the amount reflected in an invoice as issued by Nelson shall be due and payable unconditionally in (a) cash on acceptance of the Customer’s purchase order by Nelson; (b) if the Customer is a credit approved Customer, within 30 days from the date the invoice was issued by Nelson or as otherwise agreed to by Customer and Nelson in writing; or (c) prepayment prior to commencement of work if required by Nelson. Settlement of an invoice is effected only on receipt of cash or due honor of a check or similar payment instrument in the full amount without deductions of any nature. Payment for the services rendered is the obligation of the Customer issuing the purchase order or accepting the Nelson quotation or formal project estimate evidenced by the Customer or its representative submitting samples to the laboratory for testing. The customer’s obligation to pay Nelson is not in any way conditioned upon Customer receiving payment from any third party or on any specific result from Nelson’s services. If the Customer fails to make payment within the agreed terms, Nelson shall have the full right to stop all work, withhold test data and or reports, and make all invoices immediately due and payable even if such stoppage would compromise the Customer’s study and require the Customer to prepare and submit new samples. Customer is still obligated to pay for the testing up to the date of cancellation or stoppage by Nelson. In addition, Nelson shall have the right to charge interest on all amounts not paid by the due date at the rate of 1.5% per month, compounded monthly, from the due date of payment. Customer agrees to pay all cost of collections including attorney’s fees. The Customer shall be charged a $50.00 service fee on all returned checks.
- Quotation Period and Pricing: Nelson publishes certain standard pricing for its services on its website (www.nelsonlabs.com) or, if not published, Nelson’s default pricing for the current year shall apply. Prices quoted by Nelson shall remain in effect for ninety (90) days unless otherwise stated in the quote or agreed to by the parties in writing and are subject to change after that period. The prices contained in a quotation supplied by Nelson apply specifically to the Customer, test or project named on the quote in accordance with stated specifications and documentation provided to Nelson at the time of quotation. Any subsequent testing, repeat testing, additions, and omissions to the test program or parts thereof shall be additions to the Customer’s initial quote unless otherwise agreed to in writing between the parties. In addition to the initial quoted services to be provided by Nelson, the Customer shall be obligated to pay for any additional or subsequent testing, repeat testing, additions, and omissions to the test program or any parts thereof provided by Nelson.
- Pricing Revision: The Customer representative requesting any testing quotation by Nelson shall be considered an agent of the Customer and authorized to make technical and/or cost decisions including changes to the test procedures and specifications. If Nelson is required to submit a quotation without first receiving and reviewing applicable test protocols, any pricing submitted shall be subject to change when such protocols are made available to Nelson.
- Standard Procedures and Accreditation: Nelson warrants testing is done in accordance with the referenced protocols as applicable and that reported test results will be accurate within generally accepted commercial ranges of accuracy, unless another measure of accuracy has been agreed to in writing by Nelson and the Customer. Nelson’s testing laboratory is registered with the U.S. Food and Drug Administration (FDA) and Nelson holds a number of accreditations and certifications as set forth on Nelson’s website (www.nelsonlabs.com/about/certifications). It is the Customer’s responsibility to confirm that Nelson has the accreditation Customer needs to meet the Customer’s requirements. Customer is further responsible to confirm in writing and ensure that Nelson is aware of any testing requiring accreditation or specific documentation for regulatory submission. Nelson makes no claims or guarantees that reported test results or data will meet a Customer’s requirements, be they regulatory, commercial, industrial, or otherwise. It is the complete and full responsibility of the Customer to determine if Nelson’s accreditation, certifications and protocols will satisfy the Customer’s requirements.
- Study Design Liability and Responsibility: Upon the Customer’s request, Nelson will assist in the development of test plans for a submission to a regulatory agency such as the U.S. Food and Drug Administration (test plan proposals that require more than 3 hours of preparation may require payment of a consulting fee to be agreed upon in writing between the parties). However, it is the sole responsibility of the Customer to develop, seek and obtain the regulatory agency’s pre-approval of the Customer’s study design including Nelson test protocols to be used for the submission prior to initiation of the study. The Customer assumes all liability for the design of all the testing necessary to meet regulatory and other requirements for the Customer’s specific product. Nelson’s only responsibility is to perform testing according to Customer approved protocols. Failures resulting from study design are the sole responsibility of the Customer. Pre-approval of the study design and test protocols is not a guarantee of regulatory or other approval and Nelson bears no responsibility for the acceptance or rejection of any studies submitted to the FDA, other regulatory agencies or third parties.
- Testing Terms and Conditions: The Customer agrees to be bound by Nelson’s testing terms and conditions as set forth in full on Nelson’s website at www.nelsonlabs.com (https://news.nelsonlabs.com/about/service-terms) which, are incorporated herein by reference as if fully set forth herein.
- Warranties: Nelson performs services and hence its work and reports are not governed by the Uniform Commercial Code (UCC). Except as stated in paragraph 5, Nelson disclaims all warranties, express or implied,including any warranties of merchantability or fitness for a particular purpose. Nelson shall have no liability for incidental or consequential damages of any nature whatsoever. The Customer acknowledges and agrees that Nelson provides no warranty, express or implied regarding the purchase of sterilization monitoring supplies from Nelson, including process challenge devices (PCDs), biological indicators (BIs) and related sterilization monitoring supplies provided by third party manufactures and distributed by Nelson. The Customer agrees that it shall look to and rely solely on the warranties provided by the manufactures of the PCDs, BIs and related sterilization monitoring supplies and not to Nelson.
- Customer Remedies: Nelson will provide services in accordance with this Agreement and Nelson will not have any responsibility other than to exercise reasonable skill and care in the performance of services. In the event an arbitrator described in Section 29 below makes a final determination that Nelson has failed to comply with such standards of conduct in providing services and that such failure directly caused the Customer harm, Nelson will be responsible to compensate the Customer for such direct harm, PROVIDED, HOWEVER, that the amount of such compensation will not exceed the fees paid by the Customer to Nelson for the specific portion of the services rendered that directly caused the Customer harm, and that, under no circumstances will Nelson be liable to the Customer for any incidental, indirect, consequential, or punitive damages. EXCEPT AS OTHERWISE PROVIDED IN SECTION 5 above, WE MAKE NO OTHER REPRESENTATION OR WARRANTY OF ANY KIND, WHETHER EXPRESS OR IMPLIED, WITH RESPECT TO THE SERVICES PROVIDED OR GOODS SOLD, INCLUDING, BUT NOT LIMITED TO, ANY “IMPLIED WARRANTY OF MERCHANTABILITY” OR “FITNESS FOR A PARTICULAR PURPOSE.”
- Cancellation and Suspension: Nelson begins testing upon receipt of samples from the Customer. If the Customer interrupts or suspends testing for any reason, the completed portion of the work, including (but not limited to) supplies, materials, labor, and equipment utilization shall be billed to the Customer. In such circumstances where Nelson agrees to place samples on hold, Nelson may bill the Customer stand-by charges, up to the full cost of established testing rates including storage fees, until the testing resumes or is terminated by the Customer. If the testing is terminated by the Customer, the Customer shall pay for all work performed by Nelson up to cancellation and Nelson may impose a cancellation fee of no less than $75.00 for the un-billed portion of the project.
- Program Delays: Nelson shall not be liable for any failure or delay in performance which is caused in whole or in part by acts of God (fire, flood, earthquakes, etc.), weather, strikes or other labor disturbances, shut-downs, equipment breakdowns, engineering problems or delays, fuel shortages, government priorities, or any other cause beyond the reasonable control of Nelson.
- Acceptance of Test Reports: All reports and letters issued by Nelson are for the exclusive use of the Customer to whom they are addressed. No other entity or person may rely upon or use such letter or report without the written consent of Nelson. Nelson reports apply only to the specific samples tested under stated test conditions and protocols and test results are not necessarily indicative of the qualities of apparently identical or similar test or conditions. Nelson shall have no liability for any deductions, inferences or generalizations drawn by the Customer or others from Nelson’s reports. If the Customer requests verification of any part of the test report, Nelson shall be notified within thirty (30) days of submission of the report to the Customer. Failure to notify within this thirty (30) day period acknowledges acceptance of the report. Should additional work be required for verification purposes, Nelson shall be entitled to the reasonable value of the additional work performed by Nelson. Payment for any test report or other Nelson invoice shall not be conditioned upon acceptance and/or approval of a third party or the results of the test.
- Reports and Protocols: Nelson will issue protocols upon request of the Customer who intends to submit samples to Nelson. The Customer’s purchase order must be submitted to Nelson before requested protocols are released when samples have not yet been submitted to Nelson. All protocols that are issued and not used in testing within three months from the day the protocol was sent to the Customer, may be invoiced to the Customer for the time required to prepare the protocol. No quotations from reports or use of the corporate name, “Nelson Laboratories, LLC” or any variation thereof, is permitted except as expressly authorized by Nelson. Protocols may be issued to the Customer for review and input into the services that Nelson provides.
- Sample/Data Retention: Samples may be destroyed thirty (30) days after the date of the final analysis, unless the Customer indicates otherwise in writing and prepays before the expiration of said thirty (30) day period the entire cost of any storing, packaging and shipping the sample(s) by Nelson. Nelson shall retain all data for ten (10) years, or as required by law, with a computer backup. File storage beyond ten years shall be billed at an annual rate of $30.00 per study or such other rate set by Nelson. If storage fees are not paid by customer when due Nelson shall have the right to delete or destroy the file.
- Test and Control Article Characterization: The Customer is fully responsible for all test/control article characterizations and the Customer agrees that Nelson is fully relying on the Customer for such test/ control characterizations. This includes, but is not limited to, identity, strength, purity, composition and stability. Further, the Customer as sponsor shall be responsible for the methods of synthesis, fabrication, or derivation of the sample. Nelson makes no representations or warranties of any kind (express or implied ) about the representative nature of the test/control article submitted by the Customer as required by 21 CFR part 58, subpart F section 58.105 and 40 CFR part 160 subpart F section 160.105.
- Change of Address: The Customer shall notify Nelson in writing within ten (10) days of any change of address.
- Change of Ownership: The Customer shall notify Nelson, in writing, within ten (10) days of any change in ownership of the Customer’s business. Failing such notice the entire balance shall become due and owing. If deemed necessary by Nelson in its sole discretion, customer may be required to resubmit a credit application.
- Consent to Sharing Information and Retention Periods: For the purposes of making credit risk management decisions and preventing fraud, the Customer agrees that Nelson may:
18.1 Carry out a credit inquiry on the Customer from time to time with one or more credit bureau, credit information agents, credit insurance companies or other creditors (including but not limited to trade references) of the Customer in terms of this Agreement.
18.2 Transmit information to credit bureaus, credit information agents, credit insurance companies or other creditors of the Customer of how the Customer has performed in meeting his/her/its obligations under this Agreement.
18.3 Retain such information for periods as stipulated in any applicable law, but no longer than the duration of the validity of this Agreement. Where the Customer has not used Nelson’s services under this Agreement for 24 months, the Customer may be required to re-apply for such credit.
- Standard Pricing and Increments: The purchase price for any services ordered shall be Nelson’s standard price for such services prevailing as of the order receipt date when samples arrive at Nelson for processing, irrespective of when the order for such services were placed by the Customer. The Prices quoted by Nelson are subject to change at the sole discretion of Nelson. Nelson shall be entitled to increase the price of services to the Customer without prior notice unless the Customer has a valid quote from Nelson for such specific service quoted.
- Valid Orders: It is the sole responsibility of the Customer to determine that services ordered are suitable for the purposes of the Customer’s intended use. Any order provided to Nelson, notwithstanding the fact that such order may have been given or signed by a person not authorized by the Customer, shall be deemed to constitute a valid order.
- Shipping/Transportation: The Customer shall be responsible for the transportation and any associated shipping costs of Customer’s property to and from Nelson and all liability for damage, storage or mishandling prior to receipt at Nelson.
- Sub-Contractors: Nelson may, in Nelson’s sole discretion, retain the services of a sub-contractor meeting Nelson’s qualifications to perform any of the services contracted for by the Customer. Nelson is fully authorized to invoice the Customer for such services at Nelson’s standard rates. Customer may be notified when subcontracted services are required and may be required to approve subcontracted studies.
- Copyright: The Customer acknowledges and agrees that all testing protocols or processes used to generate test results are the sole ownership of Nelson. No rights or ownership of Nelson’s copyrights or other intellectual property of Nelson is transferred by invoicing the customer for protocols used in the performance of the service by Nelson. Customer agrees that it shall not infringe upon any of the intellectual property rights of Nelson.
- Payment to Nelson: All payments shall be made to Nelson’s place of business. In the event of any payments being mislabeled; lost in the postal service; or transferred to the incorrect bank account the Customer shall still be liable to Nelson for payment. Should Nelson at any time advise the Customer of any change to Nelson’s banking account details the Customer shall confirm such change with the account manager of Nelson before effecting any further payments. Nothing contained herein shall be interpreted as Nelson providing any type of an extension of any payment terms afforded to the Customer under the Agreement.
- Reservation of Ownership: Nothing in this Agreement shall be construed as a sale or transfer of Nelson’s copyrights, trademarks or any other intellectual property owned or held by Nelson. Until such time as the Customer has paid Nelson in full with respect to any services provided by Nelson, the license to use any test results or any data related thereto shall be prohibited and shall remain the property of Nelson. Nelson shall, in its sole discretion, without notice to the Customer, be entitled to take possession of any such reports which have not been paid for and in respect of which payment is overdue, in which event the Customer shall not be entitled to a credit in respect of the services not paid for.
- Payment Default: In the event of the Customer defaulting in making payment of any amount that has become due and owing, then the full balance outstanding (whether due or not) will immediately become due and payable without notice to the Customer.
- Interest on Overdue Accounts: Nelson shall be entitled but not obliged to charge late payment interest on any overdue amount at the rate of 1.5% per month, compounded monthly from the due date of payment or if lower, at the maximum rate permissible under the law (if applicable).
- Governing Law and Consent to Jurisdiction: The Customer hereby agrees that this Agreement and all other agreements between Nelson and the Customer shall be deemed to be made and governed by the Laws of the State of Utah. The Customer hereby consents that any legal action brought by Nelson for collection of any fees or invoices not paid by the Customer or other rights as provided in section 29 below, shall be brought in a court of competent jurisdiction in Salt Lake County, Utah, or if the action is to be in federal court, in the U.S. District Court for the District of Utah.
- Dispute Resolution: Any dispute or disagreement, other than nonpayment of Nelson’s fees or invoices and as otherwise set forth below, relating to the Customer or any services provided under this Agreement or under any agreement between the parties, will be settled by confidential, binding arbitration administered by American Arbitration Association (“AAA”) pursuant to the AAA Commercial Arbitration Rules and the Procedures. The arbitration venue will be Salt Lake City, Utah. The arbitration will be conducted before a single arbitrator. The arbitrator will be an individual with substantial business experience of at least fifteen (15) years in the corporate and commercial transaction areas or comparable judicial or legal experience in these areas. The arbitrator will be selected as follows: The parties shall request a list of ten (10) arbitrators drawn from the AAA’s list of qualified arbitrators (who are experienced in the areas as set forth above and are familiar with the AAA’s Procedures). From this list, both parties will each choose one arbitrator and agree on who shall serve as arbitrator. If they cannot agree on an arbitrator, the two (2) arbitrators selected will agree on a third arbitrator from the list of ten (10), who will serve as the arbitrator to conduct the arbitration. The arbitrator will not have the authority to add, change, or disregard any term of this Agreement or under any agreement entered into pursuant to this Agreement, or make and award against Nelson of any incidental, consequential, or punitive damages (including, but not limited to, loss of use, unjust enrichment, and/or lost profits), or exceed the remedies provided by Section 9 above, or the limitation of liability and release and waiver described in Sections 30 and 31 below. The arbitrator’s decision will be binding and judgment on the arbitration award may be entered by a court of competent jurisdiction. Arbitration will be the final remedy for any dispute between the parties arising out of this Agreement or any agreement entered into pursuant to this Agreement, provided, however, that nothing herein shall prevent any party from seeking a court order for injunctive relief (in addition to other remedies) to stop or prevent misuse or misappropriation of Nelson’s testing reports, trademarks or copyrights, confidential or proprietary information, or testing data, or infringement of its intellectual property, in a court of law.
- Third Party Claims: CUSTOMER AGREES TO INDEMNIFY AND HOLD HARMLESS NELSON AND ITS, DIRECTORS, OFFICERS, EMPLOYEES, AFFILIATES, AGENTS AND SUBCONTRACTORS (EACH AN “INDEMNIFIED PARTY”) FROM ALL LOSSES AND EXPENSES (INCLUDING REASONABLE ATTORNEYS’ FEES) ARISING OUT OF, OR RELATED TO, CLAIMS ASSERTED BY THIRD PARTIES THAT RELATE TO THE TESTING RESULTS OR TESTING DATA PROVIDED BY NELSON TO CUSTOMER, OR THE MANUFACTURE, MARKETING, OR SALE OF CUSTOMERS PRODUCTS OR THAT RELATE TO THE SERVICES.
- Release and Waiver: TO THE EXTENT PERMITTED BY LAW, CUSTOMER WAIVES AND RELEASES NELSON AND ITS DIRECTORS, OFFICERS, EMPLOYEES, AFFILIATES, AGENTS AND SUBCONTRACTORS FROM ALL LIABILITY, CLAIMS, DEMANDS, ACTIONS, OR CAUSES OF ACTION FOR ANY ALLEGED LOSS, DAMAGE, OR INJURY, OTHER THAN A CLAIM FOR COMPENSATION FROM NELSON PURSUANT TO SECTION 8. THIS RELEASE AND WAIVER COVERS ALL CLAIMS ARISING IN TORT AS WELL AS THOSE ARISING UNDER ANY STATE OR FEDERAL STATUTE, THAT IN ANY WAY ARISE OUT OF, OR RELATE TO, THE SERVICES OR PERFORMANCE OR ALLEGED NON-PERFORMANCE UNDER ANY AGREEMENT BETWEEN THE PARTIES.
- Recovery of Legal/Collection Costs: Should Nelson instruct its attorneys or collection agent to collect any overdue amounts, or to take any action against the Customer in the implementation or protection of Nelson’s rights, Nelson shall be entitled to the recovery of all legal fees, costs and/or collection costs arising there from.
- Non-Waiver of Rights: Failure to act on any breach of any of the provisions hereof by Customer or other act, indulgence or grace by Nelson shall not in any way operate as or be deemed to be a waiver by Nelson of any rights under this Agreement, or be construed as a novation thereof.
- Severability of Clauses: Each clause of these conditions of service, except for pricing, is severable, the one from the other and if any one or more clauses are found to be invalid or unenforceable, that clause/clauses shall not affect the balance of these conditions of services provided, which shall remain in full force and effect.
- Electronic Signature: This Agreement and any related agreement between the parties may be executed and delivered by facsimile, PDF or by means of other electronic signature and such facsimile, PDF or other electronic signatures shall be deemed to be valid and original.
- Entire Agreement: This Agreement, along with the Nelson final quote, the Customer’s purchase order (not including any Customer proposed terms or conditions), the Account Terms and Conditions, and Nelson’s confirmation of sale contains the entire Agreement between the parties. Any variations, cancellations or additions to this Agreement shall not be of any force or effect unless reduced to writing and signed by the parties.