Sterilization Processing Agreement

This Agreement (the “Agreement”) sets forth the Terms and Conditions (the “Terms”) governing the use of sterilization processing services provided by Boulder BioMed, LLC, a Colorado limited liability company with a place of business located at 5421 Western Ave., Boulder, CO 80301 (“Boulder BioMed”), doing business as Boulder iQ and Boulder Sterilization Services.

This Agreement is entered into as of the date of first use of services or execution of a written agreement referencing these Terms (the “Effective Date”) between Boulder BioMed and the client utilizing these services (“Company”). Boulder BioMed and Company may be referred to herein individually as a “Party” and collectively as the “Parties.”

By engaging Boulder BioMed for services or otherwise accepting these Terms, Company agrees to be bound by all provisions set forth herein. These Terms are intended to clarify the responsibilities, limitations, and rights of each Party in connection with the sterilization services provided by Boulder BioMed. If Company does not agree to these Terms, it should not proceed with the use of services.

  1. Records. Sterilization Processing Services documentation related to Company products shall be provided to Company and/or retained by Boulder BioMed for at least five years after service has been completed. In the event that records are disposed of in fewer than seven years, Boulder BioMed shall confirm that Company has received records.Boulder BioMed shall assign an order number to each load of Products for processing. Boulder BioMed will record this number, the name of the Products, the quantity, the processing date, processing parameters, and the chamber used. A Certificate of Processing  will be provided with  a load of product. Processing Records will be available for inspection upon request by federal or state regulatory agencies; Customer hereby consents to making such information available. Upon completion of processing Boulder BioMed shall label the devices as “EO Processed” or “CD Processed” and provide copies of Processing Records to the Customer.‌
  2. Sterilization Process Validation.The Company acknowledges and agrees that it is solely and exclusively responsible for (i) ensuring that the process and specifications are appropriate for the Products, (ii) the validation of the sterilization cycle, (iii) product sterility, (iv) the integrity of product packaging, (v) the adequacy of product labeling and (vi) compliance with any and all FDA or other regulatory requirements. Company further agrees that it is Company’s sole responsibility to comply with any and all Federal, State, and Local labeling requirements.  If a validation has been completed or is being completed, the product definition, loading configuration, biological indicators, process challenge devices and product test samples will be defined in the protocol prior to execution. Routine processing cycle specifications will be defined in the sterilization validation report.
  3. Process Definition Cycle Parameters and Process Control. Engineering Run (non-production) cycle parameters will be defined in a Sterilization Processing Form or Online Order Form filled out by the Company. If specific parameters are not requested, a standard worst-case cycle will be utilized.
  4. Release of Product. The Company is responsible for final release of product for sale. Boulder BioMed will hold product in quarantine until biological indicators (if applicable) are tested and will release product after all required data and reviews are completed. Boulder BioMed will provide a certificate of processing with each lot and if applicable and upon request can provide cycle run records, deviations, investigations (if applicable), laboratory test results (if applicable). In the event of a process failing to meet specification, Boulder Biomed will follow internal procedures for non-conforming product.
  5. Control of changes, process deviations, and product damage.When there are proposed changes to Company-specific documents or procedures, including planned deviations or product damage, Boulder BioMed will provide written notification to Company prior to implementing changes. Changes shall be implemented through the Boulder BioMed Quality System. If Company has changed any product design or packaging, the Company must notify Boulder BioMed if Boulder BioMed is doing routine EO or CD processing.
  6. Deviations and/or Reprocessing of loads. Process deviations affecting Company product shall be documented with notification to Company. Reprocessing of loads will be defined in the validation. The Company will be notified of product reprocessing.
  7. Material product handling and documentation.Boulder Biomed will follow internal procedures for material product handling and documentation.
  8. Shipping, Storage and Receiving Criteria.‌ Prior to Sterilization Processing. Product received from the Company, already packaged and labeled, prior to sterilization shall be clearly labeled “non-sterile”. Each shipment will be accompanied by a completed Sterilization Processing Order Form. Boulder Biomed shall receive product following internal procedures. During receiving, Boulder BioMed will verify the product count; in the event of any discrepancy, Company shall be notified immediately, and it shall be Company’s responsibility to locate the lost material. No material in any batch will be processed until the Parties are in agreement as to the exact count. Boulder BioMed shall maintain Company product in such a way as to maintain traceability and minimize risk of damage, contamination, and deterioration, including appropriate labeling and segregation.
    b. After Completion of Sterilization Processing services.Following the business day upon which services are completed, Boulder BioMed will store the product on its premises for a period of up to 5 business days after Boulder BioMed quality assurance (QA) releases product to the Client. Company agrees that product shall be in ambient storage conditions.Company shall provide Boulder BioMed with post-services delivery instructions. If Boulder BioMed has not received written instruction from Company regarding product shipment Boulder BioMed will return product to the shipping containers used for product delivery and label the shipping containers that sterilization processing has been completed. Shipping, unless stated otherwise, is a Company expense.
  9. Flammability/ Stored Energy.Company acknowledges that processing using EO is an extremely combustible environment. Products that contain batteries or other stored energy devices should be disclosed to Boulder BioMed prior to EO processing.
  10. Complaints. Company is responsible for processing complaints, recalls, and market withdrawals. Boulder BioMed agrees to supply information and conduct tests and/or investigations that may be required to support these actions as they apply to Boulder BioMed processes.
  11. Subcontracting. Boulder BioMed may perform Services or delegate its obligations under this Agreement through use of subcontractors without Company’s prior consent; provided that any such subcontracted Services will be subject to a binding written agreement with such subcontractor that is consistent with the terms of this Agreement.  Boulder BioMed will be responsible for the direction and coordination of the services of each subcontractor.Corrective Actions. Boulder BioMed shall respond to Company requests for corrective actions
  12. Corrective Actions. Boulder BioMed shall respond to Company requests for corrective actions by investigating for root cause and follow up with appropriate corrective and preventive actions.
  13. Audit at Boulder BioMed.
    a. Company may conduct a single one-day audit every 12 months on site at the facility. Company shall provide at least 14 days advance written notice of the date, both parties will work together to determine the best date. The audit shall be performed in a manner that does not cause disruption to operations and complies with policies and procedures while at the facility.
    b. Boulder BioMed’s employees time for the audit shall be charged at Ad Hoc rates as set forth in a Statement of Work unless such audit is necessitated directly from a material deficiency in Boulder BioMed conforming to its Quality Affairs or Regulatory Affairs policies and procedures and that adversely impact the products in a material manner.
  14. Regulatory Compliance. Boulder BioMed shall maintain compliance with ISO 13485, Medical Devices – Quality Management Systems – Requirements for regulatory purposes and 21 CFR 820. Boulder BioMed will notify Company if any of these lapses or is suspended.
  15. Confidentiality. Except as may be necessary to carry out its obligations under law or as provided in this Agreement, each party shall (i) maintain the other party’s Confidential Information in confidence during the term of the Agreement and for five (5) years after expiration or termination of the Agreement, (ii) shall limit dissemination to those of its employees and associates, including testing laboratories. who require such Confidential Information in order to perform services under this Agreement and have agreed to be bound to terms not less restrictive than those in this Agreement, and (iii) shall use such Confidential Information only to the extent necessary to perform services under this Agreement. As used in this Agreement, the term “Confidential Information” shall mean non-public information that each party provides to the other party, and reasonably considers to be of a confidential, proprietary or trade secret nature.
  16. Limited Warranty. Boulder BioMed warrants to the Company that it will process the Products in accordance with the parameters specified by the Company in the Sterilization Processing Form. If a product is damaged by BOULDER BIOMED as a result of physical mishandling, then Company’s sole and exclusive remedy shall be limited to the direct manufacturing or replacement cost of the damaged Products. Company shall use best efforts to keep all such costs to a minimum by refurbishing and/or repackaging whenever possible. BOULDER BIOMED’S AGGREGATE LIABILITY UNDER OR AS A RESULT OF THIS AGREEMENT SHALL NOT EXCEED THE GROSS PROCEEDS RECEIVED FROM THE COMPANY DURING THE THREE MONTH PERIOD IMMEDIATELY PRECEEDING THE INCIDENT GIVING RISE TO LIABILITY. IN NO EVENT SHALL BOULDER BIOMED BE LIABLE FOR ANY SPECIAL, INDIRECT, INCIDENTAL, CONSEQUENTIAL, PUNITIVE OR OTHER SIMILAR DAMAGES, INCLUDING BUT NOT LIMITED TO DAMAGES ARISING FROM DEATH, BODILY INJURY, PROPERTY DAMAGE, LOSS OF PROFITS OR REVENUE OR LOSS OF USE OF THE PRODUCTS.
  17. Warranty Disclaimer. BOULDER BIOMED MAKES NO REPRESENTATION, GUARANTEE OR WARRANTY, EXPRESS OR IMPLIED, OTHER THAN THE LIMITED WARRANTY CONTAINED IN THIS AGREEMENT, AND IN PARTICULAR CONCERNING THE STERILITY OF THE PRODUCTS OR DEGREE OF STERILIZATION, NOR AS TO THE MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OF PRODUCTS AFTER PROCESSNG BY BOULDER BIOMED.
  18. Indemnification. The Company agrees to indemnify, defend and hold BOULDER BIOMED harmless from and against all claims, suits, settlements, judgments, fines. expenses, losses, costs, deficiencies, liabilities and damages, including reasonable attorneys’ fees, court costs and expenses (“Damages”) incurred or suffered by BOULDER BIOMED arising out of or in connection with (i) any breach by the Company, its agents, employees. subcontractors or other representatives of any of its covenants. representation, warranties, obligations or agreements made in this Agreement, (ii) the processing of the Products, except to the extent such damages arise exclusively and directly from negligent acts or omissions by BOULDER BIOMED or BOULDER BIOMED fails to process the Products in accordance with the parameters set forth in Schedule A, (iii) any claim that the products are not sterile, or (iv) any claim of personal injury, including death, or other damage arising out of the use of the Products.
  19. Entire Agreement. This Agreement, including and together with any related Statements of Work, exhibits, schedules, attachments and appendices, constitutes the sole and entire agreement of the Parties with respect to the subject matter contained herein, and supersedes all prior and contemporaneous understandings, agreements, representations and warranties, both written and oral, regarding such subject matter.
  20. Notices. All notices, requests, consents, claims, demands, waivers and other communications under this Agreement (each, a “Notice”, and with the correlative meaning “Notify”) must be in writing and addressed to the other Party at its address set forth in Section 1 (or to such other address that the receiving Party may designate from time to time in accordance with this Section). Unless otherwise agreed herein, all Notices must be delivered by personal delivery, nationally recognized overnight courier or certified or registered mail (in each case, return receipt requested, postage prepaid). Except as otherwise provided in this Agreement, a Notice is effective only (a) on receipt by the receiving Party; and (b) if the Party giving the Notice has complied with the requirements of this Section 21.
  21. Severability. If any term or provision of this Agreement is found by a court of competent jurisdiction to be invalid, illegal or unenforceable in any jurisdiction, such invalidity, illegality or unenforceability shall not affect any other term or provision of this Agreement or invalidate or render unenforceable such term or provision in any other jurisdiction.
  22. Amendments. No amendment to or modification of this Agreement is effective unless it is in writing and signed by each Party.
  23. Waiver. No waiver by any Party of any of the provisions of this Agreement shall be effective unless explicitly set forth in writing and signed by the Party so waiving.
  24. Assignment. Company shall not assign, transfer, delegate or subcontract any of its rights or delegate any of its obligations under this Agreement without the prior written consent of Boulder Biomed. Any purported assignment or delegation in violation of this Section 25 shall be null and void. No assignment or delegation shall relieve the Company of any of its obligations under this Agreement.
  25. Successors and Assigns. This Agreement is binding on and inures to the benefit of the Parties to this Agreement and their respective permitted successors and permitted assigns.
  26. Relationship of the Parties. The relationship between the Parties is that of independent contractors. Nothing contained in this Agreement shall be construed as creating any agency, partnership, joint venture or other form of joint enterprise, employment or fiduciary relationship between the parties, and neither party shall have authority to contract for or bind the other party in any manner whatsoever.
  27. No Third-Party Beneficiaries. This Agreement benefits solely the Parties to this Agreement and their respective permitted successors and assigns and nothing in this Agreement, express or implied, confers on any other Person any legal or equitable right, benefit or remedy of any nature whatsoever under or by reason of this Agreement.
  28. Choice of Law. This Agreement and all related documents, and all matters arising out of or relating to this Agreement, whether sounding in contract, tort, or statute are governed by, and construed in accordance with, the laws of the State of Colorado, United States of America without giving effect to the conflict of laws provisions thereof to the extent such principles or rules would require or permit the application of the laws of any jurisdiction other than those of the State of Colorado.
  29. Choice of Forum. Each Party irrevocably and unconditionally agrees that it will not commence any action, litigation or proceeding of any kind whatsoever against the other Party in any way arising from or relating to this Agreement, including all exhibits, schedules, attachments and appendices attached to this Agreement, and all contemplated transactions, including contract, equity, tort, fraud and statutory claims, in any forum other than the courts located in the City and County of Denver, Colorado. Each Party irrevocably and unconditionally submits to the exclusive jurisdiction of such courts and agrees to bring any such action, litigation or proceeding only in the courts located in the City and County of Denver, Colorado. Each Party agrees that a final judgment in any such action, litigation, or proceeding is conclusive and may be enforced in other jurisdictions by suit on the judgment or in any other manner provided by law.
  30. Counterparts. This Agreement may be executed in counterparts, each of which is deemed an original, but all of which together are deemed to be one and the same agreement. A signed copy of this Agreement delivered by facsimile, email, or other means of electronic transmission is deemed to have the same legal effect as delivery of an original signed copy of this Agreement.
  31. Force Majeure. Boulder Biomed shall not be liable or responsible to Company, nor be deemed to have defaulted or breached this Agreement, for any failure or delay in fulfilling or performing any term of this Agreement when and to the extent such failure or delay is caused by or results from acts or circumstances beyond the reasonable control of Boulder Biomed including, without limitation, acts of God, flood, fire, earthquake, explosion, governmental actions, war, invasion or hostilities (whether war is declared or not), terrorist threats or acts, riot, or other civil unrest, national emergency, revolution, insurrection, epidemic, lock-outs, strikes or other labor disputes (whether or not relating to either party’s workforce), or restraints or delays affecting carriers or inability or delay in obtaining supplies of adequate or suitable materials, materials or telecommunication breakdown or power outage.


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