Background. You or your company (“Customer”) has submitted a purchase order (“Order”) to Kolosis BIO, LLC, a Utah limited liability company (“Supplier”), against which Supplier has issued of an invoice to Customer (“Invoice”), which Invoice references (via a Uniform Resource Locator (URL)) and incorporates by reference these Terms and Conditions. Unless, prior to submission of an Order, Customer and Supplier have an effective, written agreement that governs the purchase and sale of the goods contemplated by such Order (“Existing Agreement”), in which case the Existing Agreement shall govern and control with respect to the purchase and sale of such goods, these Terms and Conditions shall govern and control with respect to the purchase and sale of the goods contemplated by such Order (“Identified Products”). Without limiting Section 19 of these Terms and Conditions, the Invoice, together with these Terms and Conditions (this “Agreement”), constitutes the entire agreement between Supplier and Customer for the purchase and sale of the Identified Products and acceptance of these Terms and Conditions is expressly required and a condition of such purchase and sale. This Agreement (including, for clarity, these Terms and Conditions) controls over any additional, conflicting or different terms in an Order, in any surgical usage record (whether or not provided by or on behalf of Customer) or in any other documentation. If, with respect to any Order or Invoice, Customer rejects the foregoing requirement and condition, or any part of these Terms and Conditions in any way (“Objection”), Customer must return any and all Identified Products that previously were delivered to Customer as set forth in Section 8 and the Return Request (as defined in Section 8) must be received by Supplier within two (2) weeks after the later of (a) delivery of the Identified Products; and (b) Customer’s receipt of the Invoice. For clarity, if Customer does not submit a Return Request within such 2-week period, this Agreement shall be binding on Customer.
No Cancellation. Customer may not cancel, reschedule or otherwise modify any Order after submission without Supplier’s prior written consent. If Customer requests cancellation of an Order, such cancellation shall be at Supplier’s option. Supplier’s failure to meet estimated delivery or receipt dates will not be sufficient cause for cancellation of any Order.
Delivery. Supplier will use reasonable efforts to supply to Customer, by full or partial shipment, such quantity of Identified Products as set forth in an Order. Unless otherwise agreed by Supplier (a) Identified Products will be (i) packed and packaged in accordance with Supplier’s standard practices; (ii) delivered FCA (Supplier’s facility) and shipped to Customer’s address specified in the applicable Order; and (iii) shipped using third-party carriers (and delivery schedules) selected by Customer; (b) upon delivery to Customer’s selected carrier at Supplier’s facility, title and all risk of loss and damage to Identified Products shall pass to Customer and Supplier shall have no obligation or liability for goods lost, damaged, or delayed in transit; and (c) Customer shall pay all charges, including, but not limited to, all transportation and handling charges, associated with the shipment of the Identified Products. For clarity, Customer shall have sole responsibility for insuring Identified Products following delivery and any premiums or other expense associated therewith. Customer is solely responsible for filing any and all claims against carriers for loss or damage to goods in transit, and payment to Supplier shall not be withheld or delayed as a result of any such claims. Delivery dates are not guaranteed and Identified Product supply is subject to availability and other obligations. In case of shortages, Supplier may allocate Identified Products among its customers in its reasonable discretion. Supplier will endeavor to notify Customer if its Identified Product requirements will likely not be satisfied.
Prices; Payments. Prices and other amounts payable by Customer are described in the Invoice. Such prices are and shall be deemed the confidential and/or proprietary information of Supplier and Customer shall not disclose such prices to any third party or use such prices other than to fulfill its payment obligations hereunder. Unless otherwise set forth in an Invoice, all amounts shall be due and payable within 30 days after invoice date in US dollars to an account specified by Supplier, as specified in the Invoice, in full without set-off, counterclaim or deduction; provided, however, that Supplier shall have the right on written notice to Customer to demand immediate payment of amounts due if Supplier believes in good faith that the prospect of Customer’s payment or performance is impaired. Past due amounts shall bear a late payment charge until paid at the rate of 1.5% per month (18% APR) or the maximum amount permitted by law, whichever is less. If any payment is past due, Supplier shall have the right to take whatever action it deems appropriate (including without limitation, suspending performance until paid, requiring payment in advance, requiring Customer to establish an irrevocable standby letter of credit or refusing further orders). Customer agrees to reimburse Supplier for all reasonable costs (including attorneys’ fees) incurred in collecting payments. Customer’s acceptance of Identified Products shall constitute an express representation that Buyer is not then insolvent within the meaning of Title 11, United States Code or similar federal or state law.
Taxes. All prices and payments are exclusive of federal, state, local and foreign taxes (including sales, use and value added taxes), withholdings, duties, tariffs, levies and similar assessments on the sale, transport or use of any Identified Products, and Customer agrees to be liable for and pay all such charges. If Customer claims exemption from any tax, then it shall furnish Supplier with a valid tax exemption certificate issued by or acceptable to the applicable taxing jurisdiction or entity. All amounts due hereunder shall be grossed-up for any withholding taxes.
Inspection. Customer shall inspect Identified Products within a reasonable time (but, in any event, no more than five (5) business days) after receipt of Identified Products to the delivery destination specified in the applicable Order and shall report to Supplier any shortage, damage, or discrepancy in or to a shipment of Identified Products during such 5-day period and furnish written evidence of such shortage, damage, or discrepancy to Supplier. Any Identified Products not rejected timely by Customer shall be deemed accepted and, subject to the warranty set forth in Section 7 of these Terms and Conditions, shall not be returned to Supplier. If, following its review of the written evidence submitted by Customer, Supplier determines, in good faith and to its reasonable satisfaction, that such shortage, damage, or discrepancy existed at the time of delivery of the Identified Products to the carrier at Supplier’s facility, then Supplier shall, at Supplier’s election and as Customer’s sole remedy, either (a) promptly deliver additional or substitute Identified Products to Customer, at no cost to Customer but otherwise in accordance with the delivery procedures set forth in Section 3 of these Terms and Conditions; or (b) refund or credit Customer the purchase price paid by Customer to Supplier for such Identified Products. At Supplier’s request, Customer shall return any damaged Products, or Products for which Supplier was provided a refund or credit, in accordance with Section 8 of these Terms and Conditions.
Warranty; Limitations; Procedure. Supplier warrants to Customer (and only to Customer) that each of the Identified Products shall, under normal conditions and use, be free from manufacturing/processing defects in material and workmanship from the date of delivery (as contemplated by Section 3 of these Terms and Conditions) until the expiration date of such Identified Product. THE WARRANTY SET FORTH IN THIS SECTION 7 IS EXCLUSIVE AND SUPPLIER EXPRESSLY DISCLAIMS (FOR ITSELF AND ITS SUPPLIERS) ALL OTHER REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED, ORAL OR WRITTEN, INCLUDING WITHOUT LIMITATION, ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE OR APPLICATION OR QUALITY AND ANY IMPLIED WARRANTIES ARISING FROM ANY COURSE OF DEALING OR PERFORMANCE OR USAGE OF TRADE. CUSTOMER ACKNOWLEDGES AND AGREES THAT NO EMPLOYEE, INDEPENDENT CONSULTANT, REPRESENTATIVE OR AGENT OF SUPPLIER IS AUTHORIZED TO MAKE ANY STATEMENT TO THE CONTRARY OR TO ASSUME FOR SUPPLIER ANY OTHER LIABILITY IN CONNECTION WITH THE IDENTIFIED PRODUCTS. FURTHER, CUSTOMER ACKNOWLEDGES AND AGREES THAT IT (NOT SUPPLIER) IS RESPONSIBLE FOR THE SELECTION OF THE IDENTIFIED PRODUCTS AND ALL RESULTS OBTAINED FROM USE OF THE IDENTIFIED PRODUCTS, AND THAT CUSTOMER HAS RELIED SOLELY ON ITS OWN MEDICAL AND COMMERCIAL EXPERTISE, EXPERIENCE AND ANALYSES IN DECIDING TO PROCURE AND USE THE IDENTIFIED PRODUCTS. If Customer determines in its reasonable discretion that an Identified Product does not conform to the warranty set forth in this Section 7, Customer shall notify Supplier in writing and furnish written evidence of the basis for Customer’s determination. If, following its review of the written evidence submitted by Customer, Supplier determines, in good faith and to its reasonable satisfaction, that such nonconformance existed at the time of delivery of the Identified Products to the carrier at Supplier’s facility, then Supplier shall, at Supplier’s election and as Customer’s sole remedy, either (a) promptly deliver additional or substitute products to Customer, at no cost to Customer but otherwise in accordance with the delivery procedures set forth in Section 3 of these Terms and Conditions; or (b) refund or credit Customer the purchase price paid by Customer to Supplier for such Identified Products. At Supplier’s request, Customer shall return any nonconforming Identified Products, or Identified Products for which Supplier was provided a refund or credit, in accordance with Section 8 of these Terms and Conditions.
Returns; Procedure. Subject to the warranty set forth in Section 7 of these Terms and Conditions, all sales of Identified Products are final and Supplier will not accept returns of any Identified Products; provided, however, that, with respect to Identified Products that are (a) delivered to Customer within six (6) months of the Identified Products’ expiration date; (b) shipped to Customer in error; or (c) specifically authorized for return by Supplier for product complaint or recall circumstances, Supplier shall accept return of such Identified Products and credit the actual price paid to Customer’s account. In connection with returning any Identified Product, Customer must comply with Supplier’s reasonable instructions. Other than in connection with product complaint or recall circumstances, requests for Supplier to accept a return shall be initiated by written notice from Customer (including by electronic mail) advising Supplier of the nature of the request for return (each, a “Return Request”). Supplier shall have a reasonable opportunity to investigate all claims for returns (including as described in Sections 6 and 7 of these Terms and Conditions) and Customer shall cooperate with Supplier’s investigation. If Supplier agrees with the basis for the return, Supplier shall assign Customer a return goods authorization number (“RGA”). As directed and arranged by Supplier, Customer shall return the Identified Product (with prominent indication of the RGA) to Supplier. Customer shall be liable for all costs and expenses incurred in connection with any unauthorized returns. Identified Products that are returned shall be Supplier’s property.
Use of Products. Customer represents and warrants that it will (a) provide Identified Products only for use by a physician or other medical professional having all necessary certifications and licenses (in good standing) as may be required by applicable regulatory authorities and laws to perform surgical medical procedures; and (b) not resell, lease, loan or otherwise transfer Identified any Products to any third party.
Tissue Products. Customer (a) acknowledges and agrees that the Identified Products comprise human tissue; and (b) represents and warrants that (i) it has and will maintain the requisite registrations and licenses to purchase human tissue; and (ii) shall conduct all activities pursuant to this Agreement in compliance with all applicable provisions of the National Organ Transplant Act (42 U.S.C., Section 274e), all regulations promulgated by the U.S. Food and Drug Administration, and the most current edition of the Standards for Tissue Banking promulgated by the American Association of Tissue Banks.
Complaints; Recalls. Without limiting Section 10 of these Terms and Conditions, Customer shall (a) promptly report to Supplier any complaint (as defined in 21 CFR Section 820.3(b)); and (b) within 48 hours report to Supplier any event regarding of which Customer becomes aware that reasonably suggests an Identified Product (i) has or may have caused or contributed to a death or serious injury or (ii) has malfunctioned and would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur. Customer shall, as requested, cooperate with and assist Supplier in investigating such complaints and events. Subject to Customer’s legal obligations, Supplier shall determine which complaints and events are reported to regulatory authorities (including, without limitation, whether to submit a medical device report to the U.S. Food and Drug Administration). Supplier shall be responsible for any decision to implement and the execution of any Identified Product recall, field notification, market withdrawal or other comparable action and, as requested, Customer shall cooperate with and assist Supplier in connection therewith.
Traceability. Without limiting Section 10 of these Terms and Conditions, Customer shall ensure the traceability of Identified Products, and shall establish and maintain a system which allows a determination, based on records made and kept by Customer in relation to code number, amount, delivery date and reference or lot number, of the recipients of Identified Products in order to be able to carry out Identified Product-related corrective measures in accordance with instructions from Supplier or competent authorities.
No IP License. No license is granted and Supplier (and its licensors) shall retain all rights, title and interests in and to all patent rights, copyright rights, trade secret rights and all other intellectual property and proprietary rights embodied in Identified Products.
Indemnification. Each of Customer and Supplier (the “Indemnifying Party”) agrees to indemnify and hold harmless the other party (“Indemnified Party”) and its affiliates and their respective employees, independent contractors, officers, directors, representatives, agents, successors and assigns (“Indemnified Parties”) from and against any claims, suits, actions or proceedings (“Claims”) brought by any third party for losses, demands, liabilities, costs and expenses (including attorney fees) (“Losses”) that any of the Indemnified Parties may sustain or incur as a result of: (a) any breach of the Indemnifying Party’s representations, warranties, covenants or obligations under this Agreement; (b) the violation of any laws by the Indemnifying Party; and/or (c) the negligence or willful misconduct of the Indemnifying Party. In addition, Supplier shall indemnify Customer from and against any Claims for Losses as a result of allegations that Identified Products infringe or misappropriate intellectual property rights (unless the Identified Product is used other than in compliance with its labeling or is used in combination with another product or service) and Customer shall indemnify Supplier from and against any Claims for Losses as a result of use of Identified Products other than in compliance with its labeling. The foregoing indemnification shall not apply to the extent that Claims or Losses were sustained or incurred as a result of any of the Indemnified Parties’ negligence or willful misconduct or a breach of this Agreement by the Indemnified Party. The Indemnified Party shall promptly notify the Indemnifying Party in writing after it becomes aware of a Claim, or any Losses, or other fact that reasonably may give rise to a claim for indemnification under this Section 14; provided, however, that an Indemnified Party’s failure to give such notice or delay in giving such notice shall not effect such Indemnified Party’s right to indemnification under this Section 14, except to the extent that the Indemnifying Party has been prejudiced by such failure or delay. The Indemnifying Party shall, at its expense, control the defense and settlement of the matter; provided, however, that the Indemnifying Party shall not settle any claim or suit without the Indemnified Party’s prior written consent, unless such settlement is limited to the payment of cash by the Indemnifying Party and contains a full release of the Indemnified Party. The Indemnified Party shall cooperate with the Indemnifying Party as reasonably requested, at the Indemnifying Party’s sole cost and expense. The Indemnified Party has the right to participate at its own expense in the claim or suit and in selecting its own counsel therefor.
Limitations of Liability. OTHER THAN WITH RESPECT TO A PARTY’S INDEMNIFICATION OBLIGATIONS, BREACHES OF ITS CONFIDENTIALITY OBLIGATIONS, AND FOR WILLFUL MISCONDUCT, NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR INDIRECT, PUNITIVE, INCIDENTAL, RELIANCE, SPECIAL, EXEMPLARY OR CONSEQUENTIAL DAMAGES, OF ANY KIND, RESULTING FROM ITS PERFORMANCE OR FAILURE TO PERFORM UNDER THIS AGREEMENT, WHETHER ARISING OUT OF BREACH OF CONTRACT, TORT (INCLUDING NEGLIGENCE), STRICT LIABILITY, PRODUCT LIABILITY, OR OTHERWISE, INCLUDING, BUT NOT LIMITED TO, INTERRUPTION OR LOSS OF BUSINESS, REVENUES, PROFITS OR GOODWILL, OR LIABILITY OF ONE PARTY TO A THIRD PARTY, EVEN IF A PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. THESE LIMITATIONS ARE INDEPENDENT FROM ALL OTHER PROVISIONS OF THIS AGREEMENT AND SHALL APPLY NOTWITHSTANDING THE FAILURE OF ANY REMEDY PROVIDED HEREIN.
Assignability. Neither Customer nor Supplier may assign, delegate or otherwise transfer this Agreement or any of its rights or obligations hereunder, in whole or in part, without the prior written consent of the other party; provided, however, that, either Customer or Supplier may, without the prior written consent of the other party, assign or otherwise transfer this Agreement as part of a reorganization, consolidation, merger or sale of all or substantially all of its assets to which this Agreement relates. Any purported assignment, delegation, or transfer without such consent shall be null and void and of no force or effect. Subject to the foregoing, this Agreement shall be binding upon and inure to the benefit of the parties hereto and their respective permitted successors and assigns.
Governing Law; Venue. This Agreement shall be governed by and construed in accordance with the laws of the State of Delaware, without regard to its conflict of laws principles.
Governmental Requirements. Notwithstanding anything else, Customer may not provide to any person or export or re-export or allow the export or re-export of any Identified Products or anything related thereto (collectively “Controlled Subject Matter”), in violation of any restrictions, laws or regulations of the United States Department of Commerce, the United States Department of Treasury Office of Foreign Assets Control, or any other United States or foreign agency or authority. Without limiting the foregoing, Customer acknowledges and agrees that the Controlled Subject Matter will not be used or transferred or otherwise exported or re-exported to countries as to which the United States maintains an embargo (collectively, “Embargoed Countries”), or to or by a national or resident thereof, or any person or entity on the U.S. Department of Treasury’s List of Specially Designated Nationals or the U.S. Department of Commerce’s Table of Denial Orders (collectively, “Designated Nationals”). The lists of Embargoed Countries and Designated Nationals are subject to change without notice. Submission of Orders is a representation and warranty that Customer is not located in, under the control of, or a national or resident of an Embargoed Country or Designated National.
General. This Agreement constitutes the entire agreement, and supersedes all prior negotiations, understandings or agreements (oral or written), between the parties concerning the purchase and sale of Identified Products. For clarity, this Agreement, including these Terms and Conditions, shall not apply if there is an Existing Agreement. This Agreement is in English only, which language shall be controlling in all respects. No version of this Agreement in another language shall be binding or of any effect. The captions in this Agreement are included for convenience and general reference only and shall not be construed to describe define or limit the scope or intent of the provisions of this Agreement. No modification, consent or waiver to this Agreement will be effective unless in writing and signed by the party against which enforcement is sought. The parties shall be independent contractors under this Agreement, and nothing herein will constitute either party as the employer, employee, agent or representative of the other party, or both parties as joint venturers or partners for any purpose. The failure of either party to enforce its rights under this Agreement at any time for any period shall not be construed as a waiver of such rights. Unless expressly provided otherwise, each right and remedy in this Agreement is in addition to any other right or remedy, at law or in equity, and the exercise of one right or remedy will not be deemed a waiver of any other right or remedy. If any provision of this Agreement is determined to be illegal or unenforceable, that provision will be limited or eliminated to the minimum extent necessary so that this Agreement otherwise remains in full force and effect and enforceable. Any notice hereunder will be effective upon receipt and shall be given in writing, in English and delivered to the other party at its address given in the Invoice or at such other address designated by written notice. In no event shall Supplier have any liability to Customer for any delay or nonperformance that results, in whole or in part, directly or indirectly, from any condition beyond Supplier’s reasonable control (whether or not foreseeable, including but not limited to fire, flood, earthquake or other acts of God, war, terrorism, riot, civil commotion, governmental action or prohibition, accident, labor dispute or shortage, epidemic, pandemic, power or energy shortage, equipment or transportation, manufacturing yield failures or unavailability resulting from an inability to (a) obtain needed materials, equipment or supplies at commercially reasonable prices or (b) produce sufficient Products to meet the demands of all its customers). Remedies for breach of these Terms and Conditions shall survive the purchase and sale of Identified Products.
