A. Visby Medical, Inc. (“Seller”) hereby offers for sale to buyer (“Buyer”) the molecular diagnostic products and accessories listed on an Offer (defined below) or Seller’s product catalog or price list (the “Products”) on the express condition that Buyer agrees to accept and be bound by the terms and conditions set forth herein (these “Terms & Conditions”) and in any written (i) quotation issued by Seller to Buyer, (ii) signed purchase agreement between Seller and Buyer, or (iii) Seller’s pro forma invoice (each of the foregoing (i), (ii) and (iii) an “Offer”). These Terms & Conditions and any Offer (collectively, the “Agreement”), provide the complete and exclusive agreement between Seller and Buyer with respect to Buyer’s purchase of the Products. To the extent of any conflict or inconsistency between an Offer and these Terms & Conditions, the Offer shall control. Any provisions contained in any document issued by Buyer related to the purchase of the Products are expressly rejected. Buyer’s submission of a purchase order or acceptance of an Offer shall constitute Buyer’s acceptance of these Terms & Conditions. No waiver, repudiation, succession, modification, amendment or change of these Terms & Conditions shall be binding unless in writing and signed by Seller and Buyer. Seller’s failure to object to terms contained in any subsequent communication from Buyer shall not be deemed a waiver or modification of the terms set forth herein. All orders by Buyer are subject to acceptance in writing by an authorized representative of Seller, and Seller’s acceptance of any purchase order is conditional on Buyer’s unqualified assent to all of these Terms and Conditions. Unless otherwise expressly agreed to in writing by Seller, the terms of any Buyer purchase order shall be subordinate to an Offer or these Terms & Conditions and shall not be binding on Seller. There are no third party beneficiaries under the Agreement. Seller may modify these Terms & Conditions at any time prior to Buyer’s purchase of Products without Buyer’s notice or consent. Buyer’s purchase of Products shall be governed by the then current Terms & Conditions. Seller may change its Terms & Conditions between Buyer’s purchases of Products.
B. All prices set forth in any Offer are valid for thirty (30) days from the receipt of such Offer by Buyer, unless otherwise stated in writing. If no price has been quoted by Seller, then the prices for the Products will be Seller’s list price in effect at the time of shipment. Each of Seller’s product catalog and list price may be changed at any time without notice. All prices and other amounts payable to Seller are exclusive of taxes and other charges as set forth in Section D and shipping charges as set forth in Section F.
C. Any price reduction or discount received by Buyer for the Products is a “discount or other reduction in price” under Section 1128B(b)(3)(A) of the Social Security Act and is otherwise intended to be a discount within the meaning of applicable federal and state anti-kickback laws and regulations. Buyer shall accurately report all prices, discounts, and rebates to third party payors, including, without limitation, Medicare and Medicaid, maintain records thereof, and provide information to third party payors, in accordance with all such contractual requirements, as required by 42 C.F.R. § 1001.952(h) and as otherwise required by applicable law. Buyer represents and warrants that it will satisfy any and all such requirements imposed on buyers, including when required by law, the requirement to accurately report, or make available upon request by a federal or state health care program or other third party payor, the net cost actually paid by Buyer for Products covered by the Agreement. Seller agrees that it shall refrain from doing anything that would impede Buyer from meeting its obligations under this Section C.
D. Prices for the Products exclude all shipping, freight, insurance, sales, excise, use, value added, and other taxes, fees, duties and other charges imposed with respect to the sale, handling, delivery, import, export or use of any of the Products. All taxes, freight and insurance are the sole responsibility of Buyer. Seller shall add to invoices taxes it deems applicable to Buyer and after receipt of payment, including such taxes from Buyer, remit to the appropriate taxing authority; provided, however, Buyer shall remain liable for all taxes, fees and duties for the Products regardless of Seller’s applicability determination.
E. Seller may invoice Buyer upon shipment for the price and all other charges payable by Buyer in accordance with the Agreement. Payment by Buyer shall be net thirty (30) days from the date of invoice. If Buyer fails to pay any amounts when due, Buyer shall pay Seller interest thereon at a periodic rate of one and one-half percent (1.5%) per month (or, if lower, the highest rate permitted by law), together with all costs and expenses (including without limitation reasonable attorneys’ fees and disbursements and court costs) incurred by Seller in collecting such overdue amounts or otherwise enforcing Seller’s rights hereunder. Seller reserves the right to require from Buyer full or partial payment in advance, or other security that is satisfactory to Seller, if at any time Seller believes in good faith that Buyer’s financial condition does not justify the terms of payment specified above. All payments shall be made in U.S. Dollars without any set-off, deduction or counterclaim. Notwithstanding anything to the contrary herein, Seller shall have no obligation to deliver any of the Products to Buyer in the event that Buyer fails to make any payment when due and payable to Seller.
F. The Products will be shipped to the destination specified on Offer or Buyer’s purchase order, F.O.B. Seller’s shipping point for domestic and international orders. Seller will have the right, at its election, to make partial shipments of the Products and to invoice each shipment separately. Seller reserves the right to stop delivery of the Products in transit and to withhold shipments in whole or in part if Buyer fails to make any payment to Seller when due or otherwise fails to perform its obligations hereunder. All shipping dates are approximate only, and Seller will not be liable for any loss or damage resulting from any delay in delivery or failure to deliver which is due to any cause beyond Seller’s reasonable control. In the event of a delay due to any cause beyond Seller’s reasonable control, Seller reserves the right to terminate the order or to reschedule the shipment within a reasonable period of time, and Buyer will not be entitled to refuse delivery or otherwise be relieved of any obligations as a result of such delay. The Products as to which delivery is delayed due to any cause within Buyer’s control may be placed in storage by Seller at Buyer’s risk and expense and for Buyer’s account. Orders in process may be canceled only with Seller’s written consent and upon payment of Seller’s cancellation charges. Orders in process may not be changed except with Seller’s written consent and upon agreement by the parties as to an appropriate adjustment in the purchase price therefor.
G. Notwithstanding the trade terms indicated above and subject to Seller’s right to stop delivery of any of the Products in transit, title to and risk of loss of the Products will pass to Buyer upon delivery of possession of the Products by Seller to the carrier.
H. Buyer shall use the Products solely to perform in vitro clinical diagnostic testing of samples taken from the human body(“Specimens”) in accordance with all applicable federal, state and local laws, rules, regulations, guidelines, directives, regulatory requirements and laboratory standards, including without limitation (if and to the extent applicable) the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) and those laws, rules, regulations, guidelines and directives pertaining to privacy and protection of personal data and health information, and for no other purpose (the “Permitted Use”). Buyer and its affiliates and their end users shall have been, and shall at all times be, properly trained, certified and licensed to use the Products including without limitation, Buyer and its affiliates and their end users shall have completed the appropriate qualification and validation procedures in order to use the Products and shall meet then-current CLIA standards. Buyer further agrees to use, and shall ensure that its affiliates and their end users use, each of the Products only one time and in accordance with the Product package inserts therefor. The Product “package insert” means, relative to a power adapter, the package insert therewith, or relative to a molecular test device, each of the package insert for the molecular test device, and the Quick Reference Guide, and the package insert for the dilution kit. Buyer shall require all of its affiliates and their end users of the Products to comply with this section.
I. Buyer shall not sell, offer to sell, lease, license, distribute or transfer the Products to third parties within or outside the country of Buyer’s delivery destination; provided that Buyer shall have the limited right to transfer the Products to any affiliate of buyer within the country of the Buyer’s delivery destination solely for such affiliates’ Permitted Use. Buyer shall cause its affiliates to comply with all the provisions of this Agreement, and any breach by any affiliate of Buyer under this Agreement shall be deemed a breach by Buyer, and Seller may proceed directly against Buyer without any obligation to first proceed against such affiliate of Buyer. An “affiliate” of a party means a person or entity that controls, is controlled by or shares common control with such party.
J. Buyer shall not use the Products to test Specimens obtained from outside of the country of Buyer’s delivery destination or to conduct Specimen testing outside the country of Buyer’s delivery destination. Buyer shall not, and shall not authorize or permit any affiliate or third party to, gain access to or determine the methods of operation of the Products, alter, modify, disassemble, dismantle, deconstruct, analyze, determine compositions or structures, design around, or reverse engineer the Products, or any part of the Products, nor attempt to, or use the Products to, refurbish, reconstruct, create, develop or contract to develop a product similar to any of the Products.
K. If Buyer wishes to use the trademarks associated with any of the Products, Buyer shall request in writing the right to use such Product trademarks and include all proposed representations of any such trademarks. Seller reserves the right to approve or reject such request, for any reason or no reason, at its sole discretion. Except as set forth above in this Section, nothing in the Agreement shall be deemed to grant or assign to Buyer any rights or licenses under any patents, patent applications, trade secrets, trademarks, copyrights or other intellectual property rights of Seller.
L. Seller represents and warrants to Buyer that the Products supplied hereunder shall, upon the date of shipment, conform to the specifications for each such Product as set forth in the Product package insert accompanying such Product (the “Specifications”); provided that Buyer and the end users maintain, handle, store and use the Products in accordance with the package insert that accompanies the Products. The warranty made hereunder is personal to the Buyer and may not be transferred or assigned to a third party. Employees, agents and sales representatives of Seller have no authority to make any representations or warranties not included herein, and any such representations or warranties should not be relied on by Buyer or its affiliates or their end users. Seller’s sole obligation, and Buyer’s sole remedy, for breach of the foregoing warranty shall be replacement of the non-conforming Product or credit for the purchase price paid for such Product (at Seller’s election), provided that Buyer (a) inspects each shipment of Product upon delivery to ascertain whether there is any reasonably detectable shortage, damage to or loss of Product in transit, and notifies Seller in writing of any such shortage, damage or loss within seventy-two (72) hours after delivery, and (b) notifies Seller in writing of any non-conformity of Product with the warranties provided for in this Section promptly but in any event within seventy-two (72) hours after delivery, and further provided that non-conforming Product is not due to accident, disaster (which includes but is not limited to: fire, explosion, flood, water, wind, lightning or interruption of power, utilities or transportation), shipping, storage, handling or use by Buyer or its affiliates or their end users other than in accordance with the Specifications, or neglect, misuse or alterations (which include, but are not limited to any deviation by Buyer or its affiliates or their end users from Specifications or other Product package insert instructions). Buyer’s failure to notify Seller of any such shortage, damage, loss or non-conformity within the timeframes set forth above shall mean that such Product meets the warranties provided for in this Section and has been irrevocably accepted by Buyer and its affiliates and their end users, and Seller shall have no further responsibility or liability therefor. Buyer may return Product to Seller only after proper written notification of shortage, damage, loss or non-conformity as set forth in this Section, and Seller has authorized a Returned Goods Authorization (RGA) prior to such return to Seller. Credit will not be allowed for returned Products without the prior written consent of Seller.
M. EXCEPT AS SPECIFICALLY SET FORTH IN SECTION L, AND TO THE EXTENT PERMITTED BY APPLICABLE LAW, SELLER MAKES NO REPRESENTATION, WARRANTY OR GUARANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY, ANY WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE OR USE, ANY WARRANTY OF NON-INFRINGEMENT, OR ANY WARRANTY OF EFFICACY, SAFETY, OR ANY OTHER STATUTORY WARRANTY. Without limiting the foregoing, Buyer agrees not to and shall not make any warranties of any kind whatsoever to any third parties, including its affiliates and their end users, regarding the Products or their performance.
N. NOTWITHSTANDING ANYTHING TO THE CONTRARY HEREIN, THE LIABILITY OF SELLER UNDER THE AGREEMENT SHALL NOT EXCEED AN AMOUNT EQUAL TO THE TOTAL PURCHASE PRICE PAID BY BUYER TO SELLER FOR THE PRODUCT(S) GIVING RISE TO SUCH LIABILITY. IN NO EVENT SHALL SELLER BE LIABLE FOR ANY INDIRECT, SPECIAL, PUNITIVE, EXEMPLARY, CONSEQUENTIAL OR INCIDENTAL DAMAGES (INCLUDING WITHOUT LIMITATION DAMAGES FOR LOSS OF USE, LOSS OF REVENUE, LOSS OF DATA, LOSS OF PROFITS OR LOSS OF GOODWILL) INCURRED BY THE BUYER OR ANY AFFILIATE, END USER OR OTHER THIRD PARTY, ARISING OUT OF OR RELATED TO PRODUCTS, INCLUDING THE PURCHASE AND SALE OF ANY PRODUCTS, OR THE USE OR FAILURE TO USE ANY PRODUCTS, HOWEVER CAUSED, UNDER ANY THEORY OF LIABILITY, REGARDLESS OF WHETHER SELLER HAS BEEN INFORMED OF THE POSSIBILITY OF SUCH DAMAGES OR IS NEGLIGENT.
O. Buyer agrees to and shall defend, indemnify and hold harmless Seller and its affiliates and their directors, officers, employees and agents (the “Seller Indemnitees”), from and against any and all liabilities, claims, demands, actions, suits and proceedings and any losses, damages, costs and expenses arising therefrom or relating thereto (including without limitation attorneys’ fees and costs of litigation, investigation and settlement regardless of outcome) that are incurred by any of the Seller Indemnitees as a result of Buyer’s or its affiliates’ or their end users’, or their respective employees’, agents’ or contractors’, handling, storage, shipment, disposal or use of Products, including without limitation as a result of any of their negligence, misconduct or breach of the Agreement or violation of any law, rule, regulation, directive, guideline, regulatory requirement or laboratory standard.
P. Buyer acknowledges that each Product and any related software and technology, including technical information supplied by Seller or contained in any documents provided or otherwise made available with Products (collectively “Items”), is subject to export controls of the U.S. government. The export controls may include, but are not limited to, those of the Export Administration Regulations of the U.S. Department of Commerce (the “EAR”), which may restrict or require licenses for the export of Items from the U.S. and their re-export from other countries. Buyer shall comply with the EAR and all other applicable laws, regulations, laws, treaties, and agreements relating to the export, re-export, and import of any Item. Buyer shall not, without first obtaining the required license to do so from the appropriate U.S. government agency: (i) export or re-export any Item, or (ii) export, re-export, distribute or supply any Item to any restricted or embargoed country or to a person or entity whose privilege to participate in exports has been denied or restricted by the U.S. government. Buyer shall cooperate fully with Seller in any official or unofficial audit or inspection related to applicable export or import control laws or regulations, and shall defend, indemnify and hold Seller Indemnitees harmless from, or in connection with, any violation of this Section by Buyer or its affiliates or their employees, contractors, consultants, agents, or end users.
Q. Buyer acknowledges that Seller has a proprietary interest in its legal and business name and reputation as well as the brand name and trademarks of its products. Therefore, Buyer agrees that it shall not use the Seller’s name nor shall Buyer mention or describe the Agreement or its relationship with Seller in any press release, advertising, marketing, and promotional materials or other publications or materials without first obtaining the prior written approval of the Seller.
R. Seller will not be liable for any delay in performance or failure to perform under the Agreement due to circumstances beyond its reasonable control including without limitation, epidemics, pandemics, quarantines, earthquakes and other acts of God, actions or inactions of government, strikes, fire, explosion, flood, riot, lock-out, injunction, interruption of transportation, supplies or utilities, unavoidable accidents, or inability to obtain supplies at reasonable prices.
S. Seller may assign the Agreement without the consent of Buyer. Buyer may not assign the Agreement or any rights hereunder, nor delegate any duties hereunder, without Seller’s prior written consent, and any such attempted assignment or delegation shall be null and void. Buyer is and shall be responsible and liable for the acts and omissions of, and any breaches of the Agreement by, its affiliates and their end users.
T. The Agreement and the rights and obligations of the parties hereunder shall be governed by and construed in accordance with the laws of the State of California, USA, without reference to its or any other jurisdiction’s choice of law rules. The application of the U.N. Convention on Contracts for the International Sale of Goods to the Agreement is hereby expressly excluded. Each party hereby irrevocably consents to the exclusive jurisdiction of the state and federal courts located in Santa Clara County, California, USA, in any action arising out of or relating to the Agreement and waives any other venue to which it may be entitled by domicile or otherwise. In the event of any legal proceeding between the Seller and Buyer relating to the Agreement, neither party may claim the right to a trial by jury, and both parties waive any right they may have under applicable law or otherwise to a right to a trial by jury. Any cause of action brought by Buyer against Seller arising under the Agreement must be brought within one (1) year from the date that such cause of action arose.
U. In the event that any one or more provisions contained in the Agreement shall be held by a court of competent jurisdiction to be invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained in the Agreement shall remain in full force and effect. Seller’s failure to enforce, or Seller’s waiver of a breach of, any provision contained in the Agreement shall not constitute a waiver of any other breach or of such provision.
V. Any notice or communication required or permitted hereunder shall be in writing and shall be deemed received when personally delivered, delivered by reputable overnight courier, or three (3) business days after being sent by certified mail, postage prepaid, to a party at the address specified in the Offer or at such other address as either party may from time to time designate to the other party in writing.
W. Seller may have provided to Buyer prior to entering into the Agreement, and in connection with the Agreement may in the future provide to Buyer, confidential information, including but not limited to information relating to Seller’s know-how, inventions, improvements, discoveries, patent applications, trade secrets, devices, compositions, formulas, ideas, designs, drawings, specifications, techniques, data, computer programs, methods, processes, suppliers, manufacturing, customers, product prices, discounts, sales data, marketing, product development and other business plans, legal affairs and financial and technical information and material embodiments thereof (“Confidential Information”). Confidential Information, which is solely owned by Seller, includes copies and derivations of and improvements on Confidential Information, and the terms and conditions of the Agreement shall be Confidential Information of Seller. Confidential Information may be disclosed orally or in writing. Buyer may disclose Confidential Information only to its affiliates and their employees, agents, contractors and consultants on a need to know basis; provided that any such person to whom disclosure is made is bound by written obligations of non-disclosure and non-use no less restrictive than those set forth herein. Buyer shall take the same degree of care that it uses to protect its own confidential and proprietary information of a similar nature and importance, but in no event using less than a reasonable degree of care. Buyer shall not use Confidential Information for any purpose except as expressly permitted under the Agreement, and shall not use or disclose any Confidential Information to apply for, secure or perfect any intellectual property rights. This obligation of confidentiality shall not apply to any information that (a) is in the public domain, (b) comes into the public domain through no fault of Buyer or anyone to whom Buyer discloses Confidential Information, or (c) is disclosed to Buyer a non-confidential basis by a third party having a lawful right to make such disclosure. Buyer shall return Confidential Information to Seller upon request.
X. Buyer acknowledges and agrees that the Agreement sets forth the entire agreement and understanding as to the subject matter hereof, and supersedes all prior and contemporaneous discussions, agreements, and writings with respect to the subject matter hereof. All previous agreements between Seller and Buyer are hereby terminated and superseded by the Agreement. The Agreement may not be amended or modified except by written agreement of Seller and Buyer. All rights and obligations under Sections H, M-X (inclusive) of these Terms and Conditions shall survive the purchase and sale of any Products and continue in full force and effect.