Account Terms and Conditions

For an account with Nelson Laboratories Bozeman (NLB) 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 BioScience and the Customer.

Updated: May 2^nd, 2022

The following Account Terms and Conditions apply to all transactions for laboratory and consulting services or study services (collectively, the “Services”) between the Sponsor or Customer (the “Customer”) and NLB Nelson Laboratories Bozeman, LLC (“NLB”) unless otherwise specified in writing by an officer of NLB:

Contract Agreement/Terms and Conditions: The Customer agrees that when placing an order with NLB, that NLB’s final price quotation as set forth in the Sales Quote 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 NLB’s confirmation to perform Services shall constitute the entire contract between the Customer and NLB (the “Agreement”). A purchase order issued to NLB shall not constitute a binding contract unless and until it is accepted and acknowledged by NLB. The Customer accepts and agrees to all of NLB’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 or otherwise) on all orders placed with NLB. Orders submitted without a quotation or formal project estimate shall be subject to NLB’s pricing then in effect and published on NLB’s website (www.NLBlabs.com) or, if not so published, NLB’s General Pricing and Fee Policies for the current year.
Credit Terms and Payment: Any credit granted to the Customer by NLB is at the sole discretion of NLB and NLB 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 NLB shall be conditioned upon approval of the Customer’s credit or payment in advance for the Services. The Customer agrees that the amount reflected in an invoice as issued by NLB shall be due and payable, unconditionally: (a) in cash on acceptance of the Customer’s purchase order by NLB; (b) within 30 days from the date the invoice was issued by NLB if the Customer has been approved for credit, or as otherwise agreed in writing between the Customer and NLB; or (c) prepayment prior to commencement of work if required by NLB. Settlement of an invoice is effected only upon receipt of cash or due by 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 NLB quotation or formal project estimate evidenced by the Customer or its representative submitting samples to NLB for Services. The Customer’s obligation to pay NLB is not in any way conditioned upon Customer receiving payment from any third party or on any specific result from the Services. If the Customer fails to make payment according to the agreed upon terms, NLB shall have the full right to cease all work, withhold test data and or reports, and cause all invoices to be immediately due and payable, even if such ceasing would compromise the Customer’s study and require the Customer to prepare and submit new samples. Customer is still obligated to pay for the Services and non-cancelable expenses up to the date Services are ceased by NLB. In addition, NLB 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 costs of collection, including attorney’s fees. The Customer shall be charged a $50.00 service fee on all returned checks.
Quotation Period and Pricing: NLB publishes certain standard pricing for the Services on its website (www.NLBlabs.com) or, if not published, NLB’s default pricing for the current year shall apply. Pricing quoted by NLB shall remain in effect for ninety (90) days unless otherwise stated in the quote or agreed upon by the parties in writing and are subject to change after that period. The prices contained in a quotation supplied by NLB apply specifically to the Customer, test or project named on the quote in accordance with stated specifications and documentation provided to NLB 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 NLB, the Customer shall be obligated to pay for any supplementary, subsequent or repeat testing, additions and/or omissions to the test program or any parts thereof provided by NLB.
Pricing Revision: The Customer representative requesting any quotation by NLB for Services 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 NLB is required to submit a quotation without first receiving and reviewing applicable test protocols, any pricing submitted shall be subject to change upon such protocols being made available to NLB.
Standard Procedures and Accreditation: NLB warrants Services are performed 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 between NLB and the Customer. NLB’s testing laboratory is registered with the U.S. Food and Drug Administration (FDA) and NLB holds a number of accreditations and certifications as set forth on NLB’s website (https://www.nelsonlabs.com/locations/bioscience-laboratories-bozeman-montana-usa/). It is the Customer’s responsibility to confirm that NLB has the accreditation Customer requires to meet its requirements. Further, Customer is responsible to confirm in writing and ensure that NLB is aware of any testing requiring accreditation or specific documentation for regulatory submission. NLB makes no claims or guarantees that reported test results or data will meet a Customer’s requirements, whether regulatory, commercial, industrial, or otherwise. It is the complete and full responsibility of the Customer to determine if NLB’s accreditation, certifications and protocols will satisfy the Customer’s requirements.
Study Design Liability and Responsibility: Upon the Customer’s request, NLB 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 determine, develop, seek and obtain the regulatory agency’s pre-approval of the Customer’s study design, including NLB test protocols to be used for the submission prior to initiation of the study, and maintain in full force and effect such regulatory approvals. 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. NLB’s only responsibility is to perform Services according to Customer approved protocols. Failures resulting from study design are the sole responsibility of the Customer. Customer will also provide all information needed to support any informed consents that may need to be obtained from testing participants for a Customer study and for submission of the proposed testing protocol to the appropriate institutional review board. Pre-approval of the study design and test protocols is not a guarantee of regulatory or other approval and NLB bears no responsibility for the acceptance or rejection of any studies submitted to the FDA, other regulatory agencies or third parties.
Warranties: Services performed by NLB, including its works and reports are not governed by the Uniform Commercial Code (UCC). Except as stated in paragraph 5, NLB disclaims all warranties, express or implied, including any warranties of merchantability or fitness for a particular purpose. NLB shall have no liability for incidental or consequential damages of any nature whatsoever. The Customer acknowledges and agrees that NLB provides no warranty, express or implied regarding the purchase of sterilization monitoring supplies from NLB, including process challenge devices (PCDs), biological indicators (BIs) and related sterilization monitoring supplies provided by third party manufactures and distributed by NLB. 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 NLB.
Customer Remedies: NLB will provide Services in accordance with this Agreement, including paragraph 5. In the event an arbitrator described in Section 28 below makes a final determination that NLB has failed to comply with such standards of conduct in providing Services and that such failure directly caused the Customer harm, NLB 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 NLB for the specific portion of the Services rendered that directly caused the Customer harm, and that, under no circumstances will NLB be liable to the Customer for any incidental, indirect, consequential, or punitive damages. EXCEPT AS OTHERWISE PROVIDED IN PARAGRAPH 5 ABOVE, NLB 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: NLB begins Services upon receipt of samples from the Customer or as otherwise agreed upon in writing by the parties. If the Customer interrupts or suspends Services 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 NLB agrees to place samples on hold, NLB may bill the Customer stand-by charges, up to the full cost of established testing rates including storage fees, until the Services resume or are terminated by the Customer. If the Services are terminated by the Customer, the Customer shall pay for all work performed by NLB up to cancellation, including non-cancelable expenses, and NLB may impose a cancellation fee of not less than $75.00 for the un-billed portion of the project.
Program Delays: NLB 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 NLB.
Acceptance of Test Reports: All reports and letters issued by NLB 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 NLB. NLB 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 apparent identical or similar testing or conditions. NLB shall have no liability for any deductions, inferences or generalizations drawn by the Customer or others from NLB’s reports. If the Customer requests verification of any part of the test report, NLB 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, NLB shall be entitled to the reasonable value of the additional work performed by NLB. Payment for any test report or other NLB invoice shall not be conditioned upon acceptance and/or approval of a third party or the results of the test.
Reports and Protocols: NLB will issue protocols upon request of the Customer who intends to submit samples to NLB. The Customer’s purchase order must be submitted to NLB before requested protocols are released when samples have not yet been submitted to NLB. 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, “NLB Laboratories, LLC” or any variation thereof, is permitted except as expressly authorized by NLB. Protocols may be issued to the Customer for review and input into the Services that NLB 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 storage, packaging and shipping of sample(s) by NLB. NLB 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 forth by NLB. If storage fees are not paid by customer when due, NLB 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 NLB 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 a sponsor shall be responsible for the methods of synthesis, fabrication, or derivation of the sample. NLB 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 NLB in writing within ten (10) days of any change of address.
Change of Ownership: The Customer shall notify NLB, in writing, within ten (10) days of any change in ownership of the Customer’s business. Failure to provide such notice will cause the entire balance owed to NLB to become due immediately. If deemed necessary by NLB, 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 NLB may:
Credit: 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.
1. 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 the obligations under this Agreement.
2. 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 the 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 NLB’s standard price for such Services prevailing as of the order receipt date when samples arrive at NLB for processing, irrespective of when the order for such Services were placed by the Customer. The Prices quoted by NLB are subject to change at the sole discretion of NLB. NLB shall be entitled to increase the price of Services to the Customer without prior notice. If the Customer has a valid quote for specified Services, such quote will prevail.
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 NLB, 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 NLB and all liability for damage, storage or mishandling prior to receipt at NLB.
Sub-Contractors: At the sole discretion of NLB, NLB may retain the services of a sub-contractor which meets its qualifications to perform any of the Services contracted for on behalf of the Customer. NLB is fully authorized to invoice the Customer for such services at NLB’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 NLB. No rights or ownership of NLB’s copyrights or other intellectual property of NLB is transferred by invoicing the Customer for protocols used in the performance of the service by NLB. Customer agrees that it shall not infringe upon any of the intellectual property rights of NLB.
Payment to NLB: All payments shall be made to NLB directly. In the event of any payments being mislabeled, lost, or transferred to the incorrect bank account, the Customer shall still be liable to NLB for payment. Should NLB, at any time, advise the Customer of any change to NLB’s banking account details, the Customer shall confirm such change with the account manager of NLB before effecting any further payments. Nothing contained herein shall be interpreted as an extension of any kind with regard to 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 NLB’s copyrights, trademarks or any other intellectual property owned or held by NLB. Until such time as the Customer has paid NLB in full with respect to any Services provided by NLB, the license to use any test results or any data related thereto shall be prohibited and shall remain the property of NLB. NLB 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 or for which payment is overdue. Customer shall not be entitled to a credit with respect to Services that may have been partially paid for.
Payment Default: In the event the Customer defaults in making payment of any amount that has become due and owing, the full outstanding balance (whether due or not) will immediately become due and payable without further notice to the Customer.
Interest on Overdue Accounts: NLB 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 NLB 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 NLB for collection of any fees or invoices not paid by the Customer or other remedies sought by NLB, 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 NLB’s fees or invoices and as otherwise set forth herein, 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 NLB 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 herein, or the limitation of liability and release and waiver described herein. 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 NLB’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 NLB 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 (I) THE TESTING RESULTS OR TESTING DATA PROVIDED BY NLB TO CUSTOMER, (II) ANY STUDY CONDUCTED BY CUSTOMER, INCLUDING WITHOUT LIMITATION, ANY INJURY TO A STUDY PARTICIPANT, (III) THE MANUFACTURE, MARKETING, OR SALE OF CUSTOMER’S PRODUCTS OR THAT RELATE TO THE SERVICES RENDERED, (IV) ANY NEGLIGENCE OR WILLFUL MISCONDUCT OF CUSTOMER, OR (V) CUSTOMER’S BREACH OF THIS AGREEMENT.
Release and Waiver: TO THE EXTENT PERMITTED BY LAW, CUSTOMER WAIVES AND RELEASES NLB 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 NLB PURSUANT TO PARAGRAPH 8 (SUBJECT TO THE LIMITATIONS CONTAINED THEREIN). 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 NLB 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 NLB’s rights, NLB shall be entitled to the recovery of all legal fees, costs and/or collection costs arising therefrom.
Non-Waiver of Rights: The failure of a party to insist upon strict performance of any provision of this Agreement or to exercise any right arising out of this Agreement shall neither impair that provision or right nor constitute a waiver of that provision or right, in whole or in part, in that instance or in any other instance. Any waiver by a party of a particular provision or right shall be in writing, shall be as to a particular matter and, if applicable, for a particular period of time and shall be signed by such party.
Severability of Clauses: If any provision of this Agreement or the application thereof is held invalid, the invalidity shall not affect other provisions or applications of the Agreement which can be given effect without the invalid provisions or applications and to this end the provisions of this Agreement are declared to be severable.
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 (as defined in paragraph 1) 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.