NextBeam Standard Terms and Conditions

  1. The following terms and conditions (these “Terms”) govern the services provided by NextBeam, LLC (“NextBeam”) to the Customer who agrees to accept these terms by issuing a Purchase Order or initiating a payment to NextBeam (the “Acceptance”).  Capitalized terms used but not defined in these Terms shall have the meaning set forth on the Cover Page of the Agreement of that certain E-Beam Processing Services Agreement to which these Terms are attached.  
  2. Terms can change at NextBeam’s discretion
    1. NextBeam may periodically update or change these Terms at its sole discretion. The Terms current on the date of the Acceptance will be the relevant Terms for that order unless otherwise agreed in writing between NextBeam and Customer.
  3. Pricing and Payment Terms.  
    1. During the first 12 months of the Initial Term and subject to the terms and provisions of this Section 3, NextBeam will provide Services to Customer at the pricing levels set forth in writing by NextBeam. Unless otherwise stated by NextBeam, these prices do not include any taxes or the cost of shipping product to or from NextBeam’s facilities. All taxes, (other than taxes on NextBeam’s income), customs, duties, and shipping costs are the responsibility of the Customer. In certain situations, NextBeam may choose to prepay taxes and/or shipping for the Customer. In these cases, NextBeam will include such taxes and shipping costs in the invoice the Customer. Customer agrees to pay the taxes and shipping charges included in such invoices.
    2. If Customer makes any changes to the product described in the PS or requires that NextBeam modify how the product is packaged or shipped, NextBeam reserves the right to update pricing to the Customer before making any such changes to the product processing, packaging or shipping. Depending on the nature of the change, NextBeam may also specify that customer must re-validate product.
    3. Payment for Services shall be due at the time of delivering product to NextBeam for processing. If Customer desires modified payment terms, Customer shall make such request to NextBeam in writing.  Upon receipt of such request, NextBeam will run a commercial credit report and, should it be satisfied with the creditworthiness of Customer, NextBeam will change Customer’s payment terms to Net 30 days from date of invoice delivered to Customer. Should Customer fail to pay any invoice within 30 days of product delivery, Customer will be responsible for interest accruing at the rate of 2% per month or the maximum amount allowed by law if lower than 2%.
    4. If Customer fails to pay any invoice in a timely fashion, NextBeam reserves the right to cease providing Services to Customer or retract Net 30 payment terms as described above by providing written notice to Customer. Should NextBeam deem it necessary to take action to recover unpaid amounts from Customer, Customer shall be responsible for any costs, such as attorney’s fees, that NextBeam incurs in seeking repayment.
  4. Customer Responsibilities.  Customer shall have the following responsibilities:
    1. Information. To enable NextBeam to supply the highest quality Services, Customer shall furnish NextBeam with all appropriate information it may request concerning product manufacture, details regarding the biological parameters of the manufacturing process, product input materials, product geometries, packing and shipping configurations, etc. If a Safety Data Sheet (SDS) for any product type is required to exist, Customer will submit the SDS for any product types shipped to NextBeam. Customer will not submit any product for processing that contains any stored energy component or controlled substance or active pharmaceutical ingredient without prior approval from NextBeam.
    2. Changes and Notification. Customer will notify NextBeam in writing of any changes that could affect E-Beam process outcomes, such as packaging changes, material changes, changes in place of manufacture or manufacturing equipment, etc. If Customer is unsure whether changes could affect E-Beam process outcomes, Customer will notify NextBeam in writing of the changes and request a consultation.
    3. Reliance on Customer-supplied Information. Customer represents and warrants that all information supplied will be true and accurate and further understands that NextBeam will rely on this information to perform its Services in accordance with required quality standards.
    4. Validation of Processing Requirements. Customer has sole responsibility for validation of processing requirements for their products prior to distributing those products for commercial use. Customer is solely responsible for the validation of the processing, packaging integrity, adequate labeling, product efficacy, and confirming that the product is in compliance with all applicable rules, regulations, and laws that apply to the design, manufacturing, storage, and distribution, and marketing of the Products. Customer is responsible for understanding which regulatory bodies regulate their Products (e.g., including but not limited to US FDA, European Union, etc.) and complying with the relevant rules, regulations, and laws of these bodies.
    5. Consistent Packaging and Shipping. Customer shall package and ship Customer’s products to NextBeam as described in the relevant portion of this Agreement. Customer shall conspicuously label all non-sterile product as such as required by law.
    6. Final QA Release. Customer shall be responsible for the final QA release of each processed “batch” of product.
    7. Prompt Retrieval. Customer shall have has 48 hours, not including weekends or federal holidays, from the date it receives notification that Services have been completed (“Processing Completion”) to collect or cause the product to be collected from the NextBeam facility. If Customer fails to collect any product left at the NextBeam facility within 2 business days, storage charges will accrue at the rates defined in the PT or applicable PS. If Customer has still not retrieved Product within 30 calendar days of Processing Completion, NextBeam may elect to either a) ship the product back to Customer at Customer’s expense, b) continue to charge the Customer for daily storage.
    8. Insurance.  Customer shall maintain at all times during the Term, adequate insurance protecting the products from any loss, casualty, or damage, including, when applicable, contractual and hospital professional liability coverage and product liability insurance resulting from the use of the products.  Customer shall maintain general liability insurance and product liability insurance resulting from use of the products.  Each insurance policy referenced above shall be in amounts not less than $2 million per occurrence and $5 million in the aggregate.  Customer shall cause NextBeam to be named as an “Additional Insured” on all policies of insurance.  Customer shall direct its insurer to notify NextBeam in writing immediately upon receipt from Customer of, or upon such insurer’s giving to Customer of, any notice relating to the non-renewal, cancellation or reduction in coverage of such insurance. 
  5. NextBeam Responsibilities.  NextBeam shall have the following responsibilities:
    1. Processing.  NextBeam will be responsible for processing product in accordance with Customer-provided processing specifications as reflected and agreed to in the written processing specifications for each product (“PS”).
    2. Repacking and labeling Product. On completion of Services, NextBeam will label the product in accordance with the instructions contained in the applicable PS and load the product at NextBeam’s facility.
    3. Shipment of Products by NextBeam. NextBeam will ship product in accordance with “Free Carrier” (FCA) terms per Incoterms 2010 standards.
    4. Irradiation Processing. Establishing and controlling the irradiation process, including equipment and process selection, qualification, validation, routine monitoring, establishing processing categories, and change control as applicable. NextBeam will notify Customer of any change to the irradiator that may impact dose distribution to Customer product.
    5. Certification of Irradiation Dose. Certification of dose is based in part on the methods used for evaluating dose distribution at the surface of or within the product, within the capability of the methods applied including statistical uncertainty. 
  6. Limited Warranty; Disclaimer
    1. Processing Warranty.  NextBeam warrants only that products shall be processed in accordance with Customer specifications set forth in an approved PS and the processes described in the NextBeam Quality System.  If, within 90 days of processing completion for a particular product, Customer or NextBeam determine that product processing does not conform to the specifications and processes described above, as Customer’s sole and exclusive remedy NextBeam shall, at its election, either: (a) reprocess the products to conform to the warranty, at NextBeam’s cost and expense; or (b) provide Customer with a credit in an amount equal to the lesser of (i) the replacement cost of the effective products, or (ii) 7 times the fees paid to NextBeam for the processing that did not meet the specifications, or (iii) the minimum run charge fee for the product in question if such a fee was applied to the applicable processing.
    2. Product Damage Warranty.  If NextBeam damages product through incorrect handling, as Customer’s sole and exclusive remedy, NextBeam shall provide customer with a credit in an amount equal to the lesser of either (a) the replacement cost of the damaged products or (b) 7 times the fees paid to NextBeam for processing the products that were damaged or (c) the minimum run charge fee for the product in question if such a fee was applied to the applicable processing.  In addition, in such event, Customer shall use best efforts to refurbish or repackage product as is possible. Within 90 days of becoming aware of any product damage for which Customer believes NextBeam is responsible, customer shall provide NextBeam with information sufficient to support a warranty claim for product damage, which shall include counts of damaged cases, units, pictures of damage, and a summary report of actions taken by Customer to minimize cost of remedying damage.
    3. Customer acknowledges that there are many effects outside of NextBeam’s control that can give rise to a change in microbiological or other conditions of the product that are not within NextBeam’s control. CUSTOMER ALSO ACKNOWLEDGES AND AGREES THAT CUSTOMER IS SOLELY AND EXCLUSIVELY RESPONSIBLE FOR PRODUCT STERILITY ASSURANCE, THE INTEGRITY AND EFFICACY OF PRODUCT AND ITS PACKAGING AND LABELING, THE VALIDATION OF THE SERVICES, THE APPROPRIATENESS OF THE PROCESSING FOR THE PRODUCTS, THE INTEGRITY AND ADEQUACY OF ANY SAMPLES SUBMITTED FOR TESTING FOR ANY SPECIFIC USE OR APPLICATION, AND ALL DECISIONS TO RELEASE CUSTOMER’S PRODUCT FOR SALE OR DISTRIBUTION.  TITLE TO AND RISK OF LOSS OF THE PRODUCTS SHALL REMAIN WITH CUSTOMER AT ALL TIMES.  CUSTOMER REMAINS LIABLE FOR THE PRODUCTS AND IS ANSWERABLE FOR THEIR POSSIBLE LOSSES OR DETERIORATION, EVEN IF THESE ARE DUE TO UNFORESEEABLE CIRCUMSTANCES. 
    4. EXCEPT AS SET FORTH ABOVE, NEXTBEAM MAKES NO REPRESENTATION OR WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE.
    5. NEXTBEAM SHALL NOT BE RESPONSIBLE FOR LOSS OF USE, LOSS OF INCOME OR PROFITS, COST OR RENTAL OF A SIMILAR PRODUCT, OR ANY OTHER CONSEQUENTIAL OR INCIDENTAL DAMAGES OF ANY KIND WHATSOEVER, WHETHER DUE TO BREACH OF CONTRACT OR WARRANTY OR TORT, INCLUDING NEGLIGENCE OF NEXTBEAM OR STRICT LIABILITY, OR ANY OTHER CAUSE. 
    6. Notwithstanding anything to the contrary stated in this Agreement or any attachments thereto, NextBeam’s and Customer’s aggregate liability relating to this Agreement shall be limited to a maximum of three times the amount paid to NextBeam by Customer over the three month period immediately before the date such liability arose.
  7. INDEMNITY. To the fullest extent permitted by law, each Party (the “Indemnifying Party”) shall indemnify, defend and hold harmless the other Party, and its affiliates, and their respective officers, directors, employees, agents, successors an assigns (collectively, the “Indemnified Parties”), against any and all claims brought by a third party, including reasonable attorneys’ fees, arising out of or related to a breach of any provision of this Agreement by the Indemnifying Party.
  8. AUDITS. Customer Audit rights. Customer has no audit rights unless otherwise agreed to by NextBeam in writing.
  9. NOTICES. All communications related to the terms of this Agreement or communication seeking approval for changes in any procedures covered thereby shall be in writing and shall be personally delivered or sent by registered or certified mail, postage prepaid, to the address indicated below, or to such other address as to the addressee shall have designated by notice given to the other party hereto and shall be effective when received.
  10. CONFIDENTIALITY; OWNERSHIP OF INTELLECTUAL PROPERTY.
    1. The parties acknowledge and agree that in connection with the services provided under this Agreement valuable technical or marketing information of a confidential nature may be exchanged by the parties; that such information will be retained by the receiving party in confidence; that the transmittal of such information by a disclosing party is upon the condition that the information is to be used solely for the purpose of effectuating the Agreement; and that the receiving party shall not, either during the term of the Agreement or after its termination, use, publish, or disclose any technical or marketing information supplied by the disclosing party. This restriction on disclosure and use shall not apply to any information which the receiving party can show by written evidence was known to it through proper means at the time of receipt thereof from the disclosing party, or which may subsequently be obtained from sources other than the disclosing party who are not bound by a confidentiality agreement with Customer or NextBeam.
    2. The parties acknowledge and stipulate that the covenants and agreements contained herein are of a special nature and that any breach, violation, or evasion by it of the restrictions of disclosure and use contained in this Agreement (i) may result in damages to the disclosing party in amounts difficult to ascertain; and (ii) may give rise to irreparable injury to the disclosing party. Accordingly, the parties agree that the disclosing party has a right to sue and is entitled to equitable relief, including, without limitation, injunctive relief and specific performance, without the necessity of proof of actual damage, against the actual or threatened breach, violation, or evasion of the Agreement by the receiving party in any proceeding that the disclosing party may bring to enforce any provision of this Agreement, in addition to any other legal remedies that may be available. In the event of any breach, violation, or evasion of the restriction on disclosure and use contained in this Agreement, the disclosing party shall be entitled to recover reasonable legal fees and all costs and expenses associated with the enforcement of any provision hereof or of the Agreement.
    3. NextBeam shall retain all trademark, copyright, trade secret, and patent rights which it may have with respect to the processing. Customer shall retain all trademark, copyright, trade secret, and patent rights it may have with respect to the products. Neither party shall use the trademark or tradename of the other party or its parents or affiliates in its company name or for otherwise conducting business with its customers.
  11. MISCELLANEOUS.
    1. Severability; Priority.  The provisions of the Agreement shall be deemed severable, and the invalidity, unenforceability or illegality of any provision of this Agreement shall not in any way affect or impair the validity, enforceability or legality of the other provisions hereof. To the extent of any conflict between the provisions of these Terms and any Appendix or other attachment to the Agreement, the terms contained in these Terms shall control to the extent of any such conflict, unless such Appendix expressly acknowledges the conflict and states the intent to modify these Terms.
    2. No Waiver.  The failure of either Party hereto at any time to require performance by the other Party of any provision of this Agreement shall in no way affect the right of such Party to require performance of that provision, and any waiver by either Party of any breach of any provision of this Agreement shall not be construed as a waiver of any continuing or succeeding breach of such provision, a waiver of the provision itself or a waiver of any right under this Agreement.
    3. Headings.  The headings are inserted in the Agreement only as a matter of convenience and for reference and are not intended to define, limit, or describe the scope of the Agreement nor the intent of any of its provisions.
    4. Entire Agreement; Amendment.  These Terms, together with documents incorporated in the Agreement by reference, represents the complete agreement, understanding and obligation between the parties concerning its subject matter and supersedes all previous negotiations, representations, commitments and agreements, whether written, oral or implied, relating to its subject matter. No change, amendment or modification of this Agreement shall be effective unless made in writing and signed by both parties. Any terms in Customer’s purchase order or any other document of order or acceptance which are different from or additional to this Agreement shall be of no force and effect. No course of dealing, or custom or usage, which is contrary to this Agreement shall serve to modify the terms of this Agreement.
    5. Force Majeure.  Neither party shall be liable for either its failure to perform or its delays in performance hereunder arising out of or resulting from causes beyond its control. Such causes include but are not restricted to acts of God, acts of Government or the public enemy, fires, floods, epidemics, power disruptions, equipment failure, quarantine restrictions, strikes, freight embargoes, unusually severe weather or default of suppliers due to any such causes.
    6. Independent Contractors. The relationship between the parties is that of vendor and independent contractor. Neither the Customer nor any of its officers, directors, agents, or employees shall be considered as an agent or employee of NextBeam. In performing obligations and accepting benefits under this Agreement, Customer acts on its own account and has no authority or power to bind or to create any express or implied obligation on NextBeam’s behalf.
    7. Assignment.  Customer shall not assign this Agreement, or any of the rights or privileges contained in this Agreement, to any third party without the written consent of NextBeam, which shall not be unreasonably withheld; provided, however, Customer may assign all or a portion of its rights and delegate all or a portion of its duties under this Agreement in connection with a merger, acquisition, or a sale of all or substantially all of its assets or its business to which this Agreement relates.
    8. Governing Law.  The Agreement and the relationship between the parties shall be governed by and interpreted in accordance with the laws of the State of South Dakota without regard to its conflicts-of-law principles.