CellFX System Standard Terms and Conditions
1.1 “Agreement” means the agreement between the Company and the Customer, including these Standard Terms and Conditions and any Purchase Orders. “CellFX Marketplace” means the website(s) hosted by the Company so that its customers can purchase goods and/or services and/or access information about the Company's goods and/or services. “Company” and “Pulse Biosciences” both mean Pulse Biosciences, Inc., a Delaware corporation, or a wholly-owned subsidiary of Pulse Biosciences, Inc., if agreed to by the Customer and Pulse Biosciences, Inc. “Console” means any CellFX System console(s) manufactured for sale by the Company or on its behalf (see, for example, item CFX10 in the Company’s current product list), including the hardware, software, and firmware provided by the Company to the Customer as part of the Console(s) in order for them to operate, and which may include component parts produced by other manufacturers/software developers. “Customer” means the entity or person identified in a Purchase Order as the purchaser of any Goods and includes the ultimate user of any Console. “Cycle Unit” means such unit-based credit(s), as may be established by the Company from time to time, needed by any Console to deliver Nano-Pulse Stimulation™ (NPS) technology to patients (see, for example, item CU05 in the Company’s current product list). “Effective Time” means, with respect to any Goods, the date and time such Goods have been shipped by the Company, or on its behalf, to the Named Destination. “Financing Agreement” means any lending, leasing, or other financing arrangement or agreement entered into by and between Lessor (see below, Section 7.2) and Customer concerning any Goods. “Goods” means any Consoles, Handpieces, Tips, Cycle Units, or other products, including equipment, purchased by the Customer from the Company, either directly or indirectly, including products purchased by Lessor on Customer’s behalf pursuant to a Financing Agreement. “Handpiece” means any CellFX universal handpiece(s) manufactured for sale by the Company or on its behalf, as may be necessary for a Console to operate (see, for example, item CH03 in the Company’s current product list). “Individual Transaction” means any Purchase Order that has been accepted by the Company, as provided herein. “Intellectual Property Rights” means all industrial and other intellectual property rights comprising or relating to (i) Patents; (ii) Trademarks; (iii) internet domain names, whether or not Trademarks, registered by any authorized private registrar or governmental authority, web addresses, web pages, websites, and URLs; (iv) works of authorship, expressions, designs, and design registrations, whether or not copyrightable, including copyrights and copyrightable works, software, firmware, application programming interfaces, architecture, files, records, data, data files, and databases, and other specifications and documentation; (v) trade secrets; and (vi) all industrial and other intellectual property rights, and all rights, interests, and protections that are associated with, equivalent or similar to, or required for the exercise of, any of the foregoing, however arising, in each case whether registered or unregistered and including all registrations and applications for, and renewals or extensions of, such rights or forms of protection pursuant to the laws of any jurisdiction in any part of the world. “Patents” means all patents (including all reissues, divisionals, provisionals, continuations, and continuations-in-part, re-examinations, renewals, substitutions, and extensions thereof), patent applications, and other patent rights and any other governmental authority-issued indicia of invention ownership, including inventor’s certificates, petty patents, and patent utility models. “Software” means all software, including any existing base software provided with any Console, as purchased, subsequent modifications, replacements, bug fixes, and Software Upgrades. “Specifications” means published Instructions for Use (“IFU”s), user’s guides and product packaging, shipping, labeling, and similar documentation provided by the Company to Customer in writing (including electronically), as updated from time to time by the Company. “Standard Terms and Conditions” means the Company’s standard terms and conditions for the commercial purchase and use of its proprietary CellFX System and related products, including those terms and conditions as may be posted to the Company’s website(s) from time to time, whether to CellFX Marketplace or otherwise. “Tip” means any CellFX treatment tip(s) manufactured for sale by the Company or on its behalf, as may be necessary to deliver NPS pulses to patients (see, for example, item CTT0252 in the Company’s current product list). “Trademarks” means all rights in and to U.S. and foreign trademarks, service marks, trade dress, trade names, brand names, logos, trade dress, corporate names, and domain names, and other similar designations of source, sponsorship, association or origin, together with the goodwill symbolized by any of the foregoing, in each case whether registered or unregistered and including all registrations and applications for, and renewals and extensions of, such rights and all similar or equivalent rights or forms of protection in any part of the world. “Upgrade” means a Software Upgrade or Hardware Upgrade, as applicable.
1.2 A “Purchase Order” means Customer’s written request to purchase one or more Goods from the Company, whether delivered electronically (e.g., through an order placed on CellFX Marketplace) or otherwise, setting forth (a) the Goods to be purchased, including SKU, UPC or other identifier, as applicable, (b) the quantity to be purchased, (c) the then-current list price for such Goods, (d) the billing address and such other information as may be needed to complete the sale, and (e) the address for delivery of the Goods (the “Named Destination”). Any other terms and conditions set forth in Customer’s Purchase Order are not part of this Agreement or terms of sale.
1.3 A “Software Upgrade” is a new release of the software and a “Hardware Upgrade” is a change to the existing hardware, in each case, containing significant new features, capability, application, or functionality, which may be purchased separately. Product “updates,” on the other hand, shall mean any modifications or replacements (including to Software) that are required by Pulse Biosciences, which will be provided at no additional charge, unless otherwise agreed.
2. CONSOLES; AUTHORIZED USE.
2.1 Use of any Console is permitted only by individuals who are: (i) licensed physicians authorized to treat patients, as defined by the applicable state medical review board in the jurisdiction in which the Console is operated (the “Territory”); or (ii) under the supervision of such licensed physicians, as permitted by applicable laws and regulations in the Territory. These individuals are collectively referred to as “authorized users.” Goods may not be used for any processes, procedures, or experiments, or for any other use for which the Console is not intended or cleared for use by the agency or organization having authority over the approval, or clearance and sale, of medical devices within the Territory and as stated in the applicable IFUs.
2.2 Customer is responsible to ensure that all authorized users have the requisite skill required to use the Goods, as defined by the applicable state medical review board in the Territory. Customer will, at all times, ensure that Customer and Customer’s employees, authorized users and agents are and remain in full compliance with all federal, state, and local laws and statutes, including without limitation state medical agencies and certification board requirements, relating to this Agreement, the Goods and their use. Customer will not permit any Console to be used or operated by anyone other than by Customer’s personnel who have been qualified and trained by an employee, agent or representative of Pulse Biosciences. Customer will ensure that authorized users comply with the Company’s Standard Terms and Conditions and all applicable Specifications. Customer shall be fully liable to Pulse Biosciences for any improper or unauthorized use of any Goods.
2.3 Resale of any Console without the Company’s written permission is strictly prohibited. If Customer breaches this re-sale prohibition, the Customer shall pay to the Company an amount equal to the then-current list price of a new Console, plus associated costs of collections, as “Liquidated Damages.” The Parties intend that the Liquidated Damages constitute compensation, and not a penalty, and agree that the harm caused by a breach of this re-sale prohibition would be impossible or very difficult to accurately estimate, and that the Liquidated Damages are a reasonable estimate of the anticipated actual harm that might arise from such a breach.
2.4 Customer acknowledges that proper operation of the Console requires use of supplies specifically engineered to meet the Company’s compatibility, quality and performance standards, and accordingly agrees to only use such supplies, including Handpieces and Tips, if provided by, or expressly authorized by, Pulse Biosciences. Use of products not provided or expressly authorized by Pulse Biosciences with any Console will void all warranties on the Console.
2.5 Consoles provided under this Agreement will be new at the time of shipment unless indicated otherwise; however, Consoles may contain components that have been previously used in other Consoles. Consoles that contain previously used components shall meet or exceed the specifications for newly manufactured Consoles and are covered by the Console Warranty.
3. PHYSICIAN FINDER AUTHORIZATION.
The Company is hereby authorized, at its sole discretion, to list Customer’s name and contact information on the Company’s website(s), as part of its “FIND A PHYSICIAN” service. Company makes no claims or warranties regarding its FIND A PHYSICIAN service and reserves the right to alter or discontinue this service, change the name of the service, or to remove any listing at its discretion. Customer may elect to withdraw from this service at any time and for any reason by providing written notice to the Company.
4. PRICING AND TAXES.
Purchase prices are valid only for the item(s) for which such prices are specified. Current pricing for consumables and other individual Goods is listed on Attachment C and is subject to price increase. Company reserves the right to modify Cycle Unit fees upon sixty (60) days’ advance notice. Prices and orders do not include national, state or local excise, sales, use, value added, or other taxes now or hereinafter enacted (“Taxes”). When such Taxes apply and the Company has the legal obligation to collect any such Taxes, then those Taxes will be included in the amount invoiced to Customer. If the Company is required to pay any such Taxes in connection with the sale (at the time of sale or thereafter), then Customer shall reimburse the Company for all amounts paid for such Taxes.
5. SHIPMENT SCHEDULES.
Company will use commercially reasonable efforts to meet shipment schedules. However, any shipment date or forecast on any order acceptance is only an estimate of the time required to make shipment. The Company will not be liable to Customer or to any third party for any loss, damages or penalty resulting from delay in delivery of any Goods for any reason, including without limitation, supplier delay, manufacturing delay, carrier interruptions, act of God, labor dispute, shortage of materials, war, insurrection, fire, explosion, acts of terrorism, or earthquake. In any such event, the delivery date will be deemed extended for a period equal to the delay. The Company reserves the right to allocate inventories and production in its sole discretion.
6. TRANSPORTATION AND RISK OF LOSS.
Unless otherwise agreed, all Goods are shipped on a carriage and insurance paid to (CIP) basis, Named Destination (Incoterms® 2020); prices include the cost of packaging, insurance, and shipping for standard shipment to the Named Destination. For overnight shipping of Tips, an expedited handling fee may be added by the Company. In no event will common carriers of Goods be construed to be acting as agents of Pulse Biosciences, and Pulse Biosciences will not be responsible for any delivery delays. The Company reserves the right to make partial deliveries. Title to Goods other than Cycle Units, including risk of loss, passes to Customer upon shipment to the Customer and title to Cycle Units passes to Customer upon delivery to Customer’s Account in CellFX Marketplace. “Incoterms® 2020” is a trademark of the International Chamber of Commerce (ICC). Use of this trademark does not imply association with, approval of or sponsorship by the ICC and the Incoterms rules incorporated herein are protected by copyrights owned by the ICC.
7. PAYMENT TERMS AND OTHER RIGHTS OF PULSE BIOSCIENCES.
7.1 The Company may, in its sole discretion, without liability or penalty, cancel any Individual Transaction if (a) the Company determines the Customer or Lessor is in violation of any payment obligations under this Agreement or otherwise in material breach of this Agreement, or (b) the Company determines the Customer’s financial condition or creditworthiness is inadequate or unsatisfactory. Upon reasonable request, the Customer will provide the Company with statements evidencing Customer’s and/or Lessor’s financial condition, as applicable. Customer shall promptly notify the Company of any events that may have a material adverse effect on Customer’s business or financial condition. Customer shall have no right to cancel or amend any Individual Transaction.
7.2 Unless otherwise expressly authorized by Pulse Biosciences in writing, payment of the full purchase price of any Goods is due prior to shipment to Customer. Payments for Consoles must be made by credit card, wire transferor, or PayPal or by other means authorized by the Company (e.g., SEPA AA, BACS). Payments for consumables (Handpieces, Cycle Units, etc.) must be made by credit card or PayPal through the designated website portal. All payments must be in the currency indicated in the Company’s posted price list, and made payable to Pulse Biosciences at its principal office in Hayward, California, or such other office as designated in the acceptance of the Purchase Order. Customer agrees to promptly pay all sums when due. Customer further agrees to pay an interest fee at the rate of one and one-half percent (1.5%) per month on any unpaid balance amounts more than thirty (30) days past due. All Customer orders, including Cycle Units, regardless of whether made by phone, e-mail, other electronic means, or Purchase Order will be binding on Customer. In the event of nonpayment, Customer agrees to pay, in addition to the principal amounts due, all collection charges incurred by Pulse Biosciences, including charges made by a collection agent, reasonable attorneys' fees, and court costs. Customer shall have no right to return Goods after they have been shipped, except for non-conforming Goods still under warranty (see Section 11, below). Pulse Biosciences shall have a right to repossess Consoles, Handpieces and Tips in the event Customer defaults on its payment obligations hereunder, and take all other actions necessary for the Company to realize the full benefit of protections available under applicable laws in the Territory.
7.3 To the extent Customer uses a third-party leasing company, bank or other lender (each a “Lessor”) to purchase any Goods, the following special terms apply: (i) Customer represents, warrants and agrees that no Financing Agreement purports to obligate or bind the Company in any manner. The Company is not a party to, and is not bound by, any Financing Agreement. (ii) Company shall not execute, authorize or permit to be filed in any recording office any financing statement (UCC-1, etc.) or other instrument similar in effect covering all or any part of any Goods or listing itself as debtor with respect to all or any part of the Goods. (iii) Company has the right to audit and inspect any actual or proposed Financing Agreements upon request and in accordance with Section 12. (iii) Notwithstanding any Financing Agreement, the Customer is the beneficial owner and user of the Goods. The Customer is responsible for securing and making any payments that are owed to the Company, or alternatively for having such payments made on Customer’s behalf. (iv) Lessor may assign or otherwise transfer any indebtedness held by it secured by any Goods to any other person, and such other person shall thereupon become vested with all the benefits in respect thereof granted to Lessor, herein or otherwise, subject however, to the Company’s Standard Terms and Conditions.
7.4 For the avoidance of doubt, the warranties of Section 11 run to the benefit of the lawful owner of the Goods. Notwithstanding anything to the contrary, upon Lessor’s written request, and subject to the Company’s prior written consent, not to be unreasonably withheld, Customer and Lessor may assign, sell, or otherwise transfer any Goods, together with the Customer’s rights, obligations, and licenses hereunder and therein, to any third-party purchaser identified by Lessor.
8. PRODUCT MODIFICATIONS AND IMPROVEMENTS.
Pulse Biosciences reserves the right to make changes and/or improvements to Consoles, Software, Goods, and other accessories and products without any obligation to include these changes in any Console, Software or other Goods belonging to the Customer. Company reserves the right, at its sole option, to require Customer to accept Software, Handpiece, Tip, and/or Console revisions or improvements deemed necessary by the Company. Customer shall make each Console, Handpiece and Tip reasonably available for any modifications or replacements required by the Company.
9. SOFTWARE LICENSE.
9.1 All Software is licensed, not sold, under a limited, personal, non-transferable (with no right to sublicense), non-exclusive, and fully revocable license to the Customer (the "Software License'') and Customer's right to use the Software under the Software License is solely in connection with the authorized use of the Goods and expressly limited by the terms hereof. The Software License is provided to Customer only to the extent that the Agreement between the Company and Customer has been properly executed, the terms and conditions of which are valid and in effect without any violation or breach by the Customer, and all payments due under this Agreement and any related agreement, if any, have been promptly paid. Customer may use the Software to operate Customer’s Consoles only in machine readable form and only in combination with the Goods with which such Software is provided. No right to use the Software is granted or implied under the Software License except as specifically provided herein and Pulse Biosciences reserves all rights not expressly granted.
9.2 Customer may only use the Software and all Goods in accordance with the Company’s instructions and Specifications, as in effect from time to time, or as otherwise expressly approved by the Company in writing. Customer shall not disclose or provide any Software, or any portion thereof, to any third party. Customer shall not: (i) copy, modify, remove, create derivative works from, tamper with, or otherwise change any Console or any part or component thereof (including without limitation any Software); (ii) except where such restriction is prohibited by law and cannot be waived by Customer, Customer shall not reverse engineer, decompile, disassemble, or otherwise attempt to derive or obtain information about the functioning of any Goods, or the source code of the Software; or (iii) sell, loan, rent, lease, or otherwise transfer use of any Console to any third party who was not properly trained and certified by Pulse Biosciences to use the Console (each of the foregoing, a “Prohibited Act”), and any attempt to do so will render the Software License null and void. Customer shall hold Pulse Biosciences harmless against any liability, loss or expenses, whether direct or indirect, arising out of any Prohibited Act. For purposes hereof, any use or attempted use of the Software and/or the Console to avoid payment of any Cycle Unit fee is considered to be improper tampering and is prohibited. Pulse Biosciences reserves the right to disable any Console if it suspects or detects any Prohibited Acts. Customer agrees to comply with all obligations imposed on Pulse Biosciences by any third party with respect to any third party’s software or hardware that may be incorporated into any Goods.
9.3 Notwithstanding the foregoing, Customer may resell, loan, rent, lease, or otherwise transfer a Console to a third party if: (i) the third party is a licensed medical practitioner both trained and certified by the Company as having already had, among other things, meaningful experience diagnosing and treating skin lesions using energy-based devices or surgery, (ii) the Console can be lawfully operated within the third party’s jurisdiction, and (iii) the Console is first returned to the Company, at Customer’s expense, so that the Console can be calibrated, tested, and reset to original factory setting and so the Software can be updated by the Company, as it deems appropriate, and provided further that the Company has given its consent to the resale or other transfer, which consent shall not be unreasonably preconditioned, delayed or withheld. In the event of an authorized resale or other transfer made in accordance with this Section 9.3, the Company will arrange for shipment, at Customer’s expense, both to the Company and to the Console’s new third party user.
10. RIGHT TO AUDIT.
Company shall have the right (during reasonable business hours and with at least 48 hour advance notice to Customer) to enter Customer’s premises for the purpose of: Set‐Up, inspecting, upgrading (including Software Upgrades), accessing, repairing, and/or obtaining data from Goods then in Customer’s possession or control; and confirming Customer’s compliance with the terms of this Agreement. Company may ensure, at its option, that the Cycle Unit fees paid are correct by updating the Software and/or Console to provide for electronic data access or exchange from Pulse Biosciences to the Console with a broadband or other acceptable highspeed internet connection, as specified below. Other methods of ensuring that Cycle Unit fees are paid in accordance with applicable Standard Terms and Conditions may be implemented at Pulse Biosciences' sole option and may include, but are not limited to (i) requesting information from the Customer; (ii) adjusting the number of Cycle Units available on the Customer’s Console(s); or (iii) in person verification by Company personnel. Company may install additional software or equipment to affect monitoring or updating relevant to verifying the count of the Cycle Units. Customer will cooperate with Pulse Biosciences in providing access to the Console and the Software (on reasonable notice as aforesaid) to perform the updating and monitoring described above. The Customer shall not permit anyone other than authorized Company personnel to alter or remove such monitoring software or devices. Failure by Customer to comply with any provision of the Standard Terms and Conditions will entitle Company to injunctive relief to prevent further use of the Software and Console until such breach is cured to Pulse Biosciences' satisfaction. Pulse Biosciences reserves the right to refuse Cycle Units and service to anyone who purchases any Console through a third party.
11. LIMITED PRODUCT WARRANTY; EXTENDED WARRANTIES AND LIMITATION OF LIABILITY.
11.1 Console Warranty. The warranty period for any Console shall be from the Effective Time until the earlier of (i) two (2) years following delivery of the Console at the Named Destination and (ii) twenty-six (26) months from the Effective Time ("Standard Console Warranty Period”). Company warrants to Customer that, during the Standard Console Warranty Period, the Console will be free from material defects in materials and workmanship and will substantially conform to the Specifications applicable to the Console, as such Specifications existed on the date of shipment ("Console Warranty”).
11.2 Handpiece Warranty. The warranty period for any Handpiece shall be from the Effective Time until the two-year anniversary of the Effective Time, for Handpieces delivered with a newly purchased CellFX Console, and until the one-year anniversary of the Effective Time, for all other Handpieces, i.e., Handpieces purchased separately (“Standard Handpiece Warranty Period”). Company warrants to Customer that, during the Handpiece Warranty Period, the Handpiece(s) will be free from material defects in materials and workmanship and will substantially conform to the Specifications applicable to the Handpiece(s), as such Specifications existed on the date of shipment ("Handpiece Warranty”).
11.3 Tip Warranty. Tips will be free from material defects in materials and workmanship and will substantially conform to the Specifications applicable to the Tip(s) when shipped (“Tip Warranty”). The Company will replace any defective Tip free of charge if received by the Company on or before the Tip’s “use by date” or within six months of its Effective Time, whichever is later (“Tip Warranty Period”).
11.4 Extended Warranties. From time to time, the Company may offer, in its sole election, extended warranty programs covering the service of Goods after the Standard Console Warranty Period, the Standard Handpiece Warranty Period, and/or the Tip Warranty Period, as applicable (each an “Extended Warranty Program”). The commercial terms for any Extended Warranty Program offered to Customer will be set forth in a separate invoice signed by the Company, which terms will include the specific Goods covered by the extended warranty, the term or terms of the extended warranty period, for example, the Standard Console Warranty Period + 2 years (each an “Extended Warranty Period”), and the price to be paid by the Customer for each extended warranty. All such terms are incorporated herein by this reference. Payments for extended warranties are non-refundable. Each Extended Warranty Period, Standard Console Warranty Period, Standard Handpiece Warranty Period, and Tip Warranty Period are herein referred to as a “Warranty Period.”
11.5 During each applicable Warranty Period, the Company will, in its sole discretion, either repair or replace, at no additional charge to Customer, any Goods found, upon examination by Pulse Biosciences acting reasonably, not to conform to the applicable foregoing warranties. This Section 11 sets forth Customer’s sole and exclusive remedy with respect to any breach of any Company warranty. No person is authorized to bind the Company to any obligations or liabilities beyond the warranties provided herein in connection with the sale of Goods, and these limited warranties apply only to the original purchaser(s) of the Goods and are not transferable, except for the Extended Warranty Programs, all of which run to the benefit of the original purchaser(s) of the warranted Goods as well as to each of the permitted transferees of the warranted Goods during the term of the Extended Warranty Period. Each permitted transferee is referred to herein as a “Customer.”
11.6 These warranties do not extend to any product (including software) not provided by the Company. Further, the warranties provided herein are contingent upon Customer’s payment of the purchase price of the Goods and any Extended Warranty Program as well as the proper use of the Console, in accordance with any instructions and Specifications. The Company will have no obligation under any warranty unless the Customer promptly reports the claim and the Company confirms to its reasonable satisfaction that the Goods are nonconforming and that a warranty applies.
11.7 All warranties hereunder are subject to the following exclusions: (a) the above warranties do not apply if the Goods have been subjected to abuse, misuse, tampering, neglect, negligence, accident, improper testing, improper storage, improper operation or handling, unauthorized repair or modification, abnormal physical stress, abnormal environmental conditions, use contrary to the applicable IFUs, or use in an operating environment other than the operating environment described in the Specifications; (b) the above warranties do not apply to Goods damaged by physical, electrical, or telecommunications infrastructure failures external to the Console; (c) no warranty is available in the event of Customer’s breach of the Agreement; (d) unopened Consumables, which are beyond the sterilization expiration date, are not covered by any warranty; (e) use of the Goods (including the Console and Software) for uses for which they are not intended voids all warranties; (f) any component of the Goods that has been superseded by an update made available to Customer without charge by Pulse Biosciences is not warranted; and (h) Goods used with unauthorized consumables, used by person(s) not properly trained or authorized, or used in a manner inconsistent with their Specifications is not warranted. Physical in-warranty repair or replaced parts are warranted only for the unexpired portion of the original Warranty Period. No product returned for any service or warranty will be accepted by Pulse Biosciences unless a Return Material Authorization number has been previously obtained from the Company’s Customer Service Department.
11.8 EXCEPT AS SET FORTH IN THIS SECTION 11, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, PULSE BIOSCIENCES DISCLAIMS ALL WARRANTIES, WHETHER EXPRESS OR IMPLIED, WRITTEN OR ORAL, INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT, AND ANY WARRANTIES ARISING OUT OF COURSE OF DEALING, USAGE OF TRADE OR OTHERWISE. FURTHERMORE, PULSE BIOSCIENCES DOES NOT WARRANT THAT THE OPERATION OF THE SOFTWARE AND CONSOLES SHALL BE UNINTERRUPTED OR ERROR FREE. IN NO EVENT, WILL PULSE BIOSCIENCES BE LIABLE FOR ANY SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE, OR CONSEQUENTIAL DAMAGES, ARISING OUT OF, RELATING TO, OR IN CONNECTION WITH THIS AGREEMENT, OR PERFORMANCE, USE OR INABILITY TO USE ANY CONSOLE OR SOFTWARE, WHETHER SUCH LIABILITY ARISES FROM ANY CLAIM BASED UPON CONTRACT, WARRANTY, TORT, PRODUCT LIABILITY, OR OTHERWISE, EVEN IF PULSE BIOSCIENCES HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH LOSS OR DAMAGE AND REGARDLESS OF THE FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED WARRANTY. PULSE BIOSCIENCES’ AGGREGATE LIABILITY ARISING OUT OF OR RELATING TO THIS AGREEMENT FROM ALL CAUSES OF ACTION AND UNDER ALL THEORIES OF LIABILITY, EXCEPT WHEN CAUSED BY INTENTIONAL MISCONDUCT, SHALL NOT EXCEED THE TOTAL FEES ACTUALLY RECEIVED BY PULSE BIOSCIENCES FROM OR ON BEHALF OF CUSTOMER FOR THE PRODUCT(S) RESULTING IN THE LOSS OR DAMAGE CLAIMED IN THE TWELVE (12) MONTHS PRECEDING SUCH LOSS. SOME JURISDICTIONS MAY NOT ALLOW THE EXCLUSION OF CERTAIN IMPLIED WARRANTIES OR CERTAIN LIMITATIONS OF LIABILITY, TO THE EXTENT PROHIBITED BY LAW SUCH EXCLUSIONS SET FORTH HEREIN MAY NOT APPLY TO CUSTOMER. THE PARTIES ACKNOWLEDGE THAT THE FOREGOING LIMITS AND LIMITATIONS, AND THE PRICES SPECIFIED IN THIS AGREEMENT ARE FUNDAMENTAL PARTS OF THE BASIS OF THE BARGAIN AND REFLECT THE ALLOCATIONS OF RISK SET FORTH IN THIS AGREEMENT, AND THAT PULSE BIOSCIENCES WOULD NOT ENTER INTO THIS AGREEMENT WITHOUT THE FOREGOING LIMITATIONS OF ITS LIABILITY AND THE WARRANTY DISCLAIMERS CONTAINED HEREIN.
11.9 For more information about these warranties or to obtain performance of any obligation under any warranty, Customer must contact the Company’s Customer Service Department at 833.257.3393. The above limited warranties give Customer specific legal rights, and Customer may also have other rights which vary from Country to Country and State to State.
11.10 The following informal dispute resolution procedure is available if a Customer believes the Company has not performed its obligations under any warranty: mediation before a jointly selected third-party mediation service, followed by binding arbitration pursuant to Section 22, below. Customer must use these alternative dispute resolution procedures before pursuing any legal remedy in the courts.
12. TRADEMARKS AND COPYRIGHTS.
12.1 The Company is the owner of the CellFX, CellFX Marketplace, CellFX Cloud Connect, Nano-Pulse Stimulation, NPS, and Pulse Biosciences trademarks and other trademarks (including stylized logos) in the United States and around the world. Pulse Biosciences is also the owner of all written materials provided to Customer directly by the Company or through a third-party or a website download, including educational, marketing, branding, and advertising materials, and materials provided as part of a promotional kit (collectively, “Materials”), and such Materials are protected by U.S. and international copyright laws and provisions. All Materials are provided on an “as is” basis. Neither Customer nor Pulse Biosciences will use the trademarks, logos, images, or name of the other Party in any advertising or other form of publicity without the written permission of the other Party, except pursuant to Section 3, above (“Physician Finder Authorization”).
12.2 Upon completion of practice education, Customer shall become an authorized user of the Company’s Goods and authorized in connection therewith to use the Company’s Trademarks and Materials solely in Customer’s promotion and delivery of services using the CellFX System, and in accordance with the terms hereof.
12.3 Subject to the express rights and licenses granted by Company in this Agreement, Customer acknowledges and agrees that: (a) any and all of the Company’s Intellectual Property Rights are the sole and exclusive property of the Company and its licensors; (b) under this Agreement, Customer shall not acquire any ownership interest in any of the Company’s Intellectual Property Rights; (c) any goodwill derived from the use by Customer of Company’s Intellectual Property Rights inures to the benefit of the Company or its licensors, as the case may be; (d) if Customer acquires any Intellectual Property Rights in or relating to any Goods by operation of law or otherwise, these rights are hereby irrevocably assigned to the Company or its licensors, as the case may be, without further action by either Party; and (e) the Customer shall use the Company’s Intellectual Property Rights only in accordance with this Agreement and the instructions of Pulse Biosciences.
12.4 This Agreement does not grant either Party the right to use the other Party’s Trademarks (or the Trademarks of such Party’s affiliates), except as set forth under this Section 12.4. Subject to the CellFX and Pulse Biosciences Brand Guidelines, which may be amended from time to time in Company’s sole discretion, and the terms and conditions of this Agreement, Company hereby grants to Customer a non-exclusive, non-transferable, and non-sublicensable license to use the Company’s Trademarks in the Territory during the Term solely on or in connection with the promotion and advertising of the Goods in connection with Customer’s medical practice and use of the CellFX System (the “Trademark License”). Customer will promptly discontinue the display or use of all Company Trademarks, or change the manner in which any Company Trademark is displayed or used with regard to any Goods, when requested by Company, in its sole discretion. To the extent that Customer translates or causes to be translated any of the Company’s Materials, the Customer hereby irrevocably assigns all copyrights in these translations to the Company, subject to a non-exclusive, non-transferrable, and non-sublicensable license to Customer, hereby granted by the Company, to use the translations in the Territory during the Term solely on or in connection with the promotion and advertising of the Goods in connection with Customer’s medical practice and use of the CellFX System. Other than these express licenses and the Software License, Pulse Biosciences grants no right or license to Customer, by implication, estoppel or otherwise, to the Goods or to any of the Company’s Intellectual Property Rights.
12.5 Customer shall not: (a) take any action that might interfere with any of Company’s rights in or to the Company’s Intellectual Property Rights, including Company’s ownership or exercise thereof; (b) challenge any right, title or interest of Company in or to Company’s Intellectual Property Rights; (c) make any claim or take any action adverse to the Company’s ownership of its Intellectual Property Rights; (d) register or apply for registrations, anywhere in the world, for Company’s Trademarks or any other trademark that is similar to any of the Company’s Trademarks or that incorporates Company’s Trademarks in whole or in confusingly similar part; (e) use any mark anywhere that is confusingly similar to Company’s Trademarks, in whole or in confusingly similar part; (f) engage in any action that tends to disparage, dilute the value of, or reflect negatively on the Goods, the Company, or any of the Company’s Trademarks; (g) misappropriate any of the Company’s Trademarks for use as a domain name without prior written consent from Company; (h) alter, obscure or remove any of Company’s Trademarks, or trademark or copyright notices or any other property rights notices placed on the Goods or Materials; or (i) use any of the Company’s Intellectual Property Rights in a manner that will impair, dilute, harm, jeopardize, or tarnish the goodwill or reputation of Pulse Biosciences. Customer agrees that the use of all Materials is subject to the CellFX and Pulse Biosciences Brand Guidelines that are provided to Customer and posted on the CellFX Marketplace and incorporated herein by this reference. Customer agrees to state in appropriate places on all materials using the Trademarks of Pulse Biosciences that they are Trademarks of Pulse Biosciences and to include the symbol ™ or ®, as appropriate.
12.6 Customer shall not remove copyright notices or any trademarks from the Goods or branding materials of Pulse Biosciences. Customer shall not be entitled to use any of Pulse Biosciences Trademarks in conjunction with Customer’s own trademarks or private labels, or for any other purpose, except in the manner authorized by Pulse Biosciences.
12.7 Upon expiration or earlier termination of this Agreement, Customer’s license rights under this Agreement cease immediately and Customer shall immediately cease all display, advertising, promotion, and use of all of the Company’s Trademarks and shall not thereafter use, advertise, promote, or display any Company Trademark in any advertising or promotional materials or on any products.
13. INTERNET CONNECTIVITY.
Console(s) have inherent features that require regular connection to the internet in order to maintain optimal functionality. Console(s) will not operate unless connected on a regular basis. Failure to connect to the internet on a regular basis could result in lack of functionality. Customer shall provide Pulse Biosciences with remote access to Customer’s Console(s) and permit Company to establish a secure network connection between the Console(s) and the Company which will allow Pulse Biosciences to perform Console maintenance and repair as provided in this Agreement, and to periodically download from each Console certain treatment and Console usage, utilization and performance information. Such information may be used from time to time by Pulse Biosciences, for example, for the purpose of restocking Tips to inventory, assuring proper operation and performance of the Console, running diagnostics, recording and correcting errors, verifying proper use of the Console, Tips and Cycle Units, and as otherwise required by the Company. The downloaded information will include data that identifies Customer, including but not limited to physician name(s) and the address(es) of the practice. However, the downloaded information will exclude patient individually identifiable health information or patient personal data and will be anonymized.
14. PRIVACY LAWS COMPLIANCE.
Each Party agrees to comply with all laws, rules and regulations relating to privacy and data security within the Territory, to the extent such laws, rules, and regulations are directly applicable to such Party.
All information, drawings, designs, manuals, descriptions, software, and any other non-public information furnished to the Customer by Pulse Biosciences hereunder shall remain the confidential and proprietary property of Pulse Biosciences. All such information, except as may be found in the public domain, shall be held in confidence by Customer and shall not be disclosed by, or in any way distributed by, Customer to any third parties or used by Customer other than to use the Goods and in accordance with this Agreement.
16. PUBLIC ANNOUNCEMENTS.
Customer and Pulse Biosciences shall mutually agree in writing on any public announcements/statements regarding the use of the Console by Customer, as well as any public statements by Customer about the Console. Notwithstanding the forgoing, Customer acknowledges and agrees that Pulse Biosciences may make public or media announcements regarding the use of the Console by Customer.
17. PRACTICE EDUCATION.
As needed, the Company will provide up to 10 hours of in-service practice education on the Goods to Customer’s authorized users. Practice education will be scheduled by mutual consent between Pulse Biosciences and Customer. In-Service practice education will typically occur at the Customer’s site and will be conducted in English language only. In addition, Pulse Biosciences will supply ongoing practice education, training and support as it deems appropriate (e.g., onsite, by tele/video conferencing or in designated location).
18. TERMINATION OF USE.
Customer’s use of the Console(s) (including the Software) is subject to compliance with the usage and other requirements described in this Agreement (including, without limitation, the “Authorized Use” provisions above). Customer’s authorization to operate the Console, the Trademark License, and the Software License will terminate automatically in the event Customer fails to comply with such requirements.
19. RETURN POLICY.
All sales are final. No Goods or any part thereof will be accepted for return or replacement unless and until the return has been authorized in writing by Pulse Biosciences.
20. COOPERATION AND REPORTING.
Customer will comply with all applicable laws, rules and regulations with respect to Customer’s use of the Goods and to provide information and assistance to Company and regulatory authorities as is reasonably necessary to enable the Company to comply with requirements imposed on the Company as a medical device manufacturer under applicable contracts, laws, rules and regulations. Such requirements may include, without limitation, requirements relating to product liability, product recalls and to medical device reporting requirements regarding deaths and serious injuries related to the Goods. Customer shall inform Pulse Biosciences within 48 hours if Customer becomes aware of a reportable event concerning the safety of any Goods, including, without limitation, the use of Goods that may have caused or contributed to death or to any injury that results in permanent impairment of a body function.
21. GOVERNING LAW; DISPUTE RESOLUTION.
The rights and obligations of the Parties under this Agreement shall be governed in all respects by, and construed and enforced in accordance with, the laws of the State of California, United States of America, without regard to conflict of law rules and principles. The United Nations Convention on Contracts for the International Sale of Goods is expressly excluded from this Agreement. Any controversy or claim arising out of or relating to this Agreement, or its breach, shall be subject to non-binding mediation prior to binding arbitration in San Francisco County, California, USA under the then-current Rules of Arbitration of the International Chamber of Commerce (ICC) by one arbitrator agreed upon by both parties and appointed in accordance with such Rules. The Emergency Arbitrator Provisions shall not apply. The arbitrator shall issue a written report to the parties, detailing the basis of any arbitration award. Judgment on the award rendered by the arbitrator may be entered in any court having jurisdiction. Subject to the Parties’ obligation to submit disputes to binding arbitration in accordance with this paragraph, the California state courts of the above-mentioned County, California, USA (or if there is federal jurisdiction, such as issues relating to the intellectual property associated with the Goods and Software, the United States District Court for the Northern District of California) have exclusive jurisdiction and venue over any dispute arising from or related to this Agreement. Customer hereby irrevocably, consents to the jurisdiction of such courts, and waives any objection thereto. Notwithstanding the foregoing, neither Party shall be precluded, at any time, from seeking injunctive, equitable or other provisional relief, or from submitting any decision of an arbitrator reached in accordance with this paragraph to any court having jurisdiction of the matter at issue. No action, regardless of form, arising out of or related to this Agreement may be brought by Customer more than twelve (12) months after first learning that the cause of action arose.
22. EXPORT CONTROLS.
This Agreement is made subject to any laws, regulations or other restrictions imposed from time to time by the U.S. Government on the export from the United States. Customer agrees to comply with all such export laws, regulations and restrictions of the U.S. Department of State, Department of Commerce and/or other relevant legal authority. Customer will not ship, transfer or export in any manner, either directly or indirectly, the Console or any other Goods without first obtaining all necessary approvals from appropriate government agencies as may be applicable.
23. GENERAL LEGAL.
The relationship between Pulse Biosciences and Customer under this Agreement is solely that of independent contractors, and no partnership, agency, employment, franchise, joint venture, or other relationship is created hereunder. The captions, section and subsection headings used in this Agreement are for purposes of convenience only; they shall not be construed to limit or extend the meaning of any part of this Agreement. The Company reserves the right to amend, alter or terminate its Standard Terms and Conditions at any time and for any reason by posting updates to the Company’s website(s), as applicable. This Agreement is written in the English language as spoken and interpreted in the United States of America, and such language and interpretation shall be controlling in all respects. The Parties are sophisticated and have been represented (or have had the opportunity to be represented) by their separate attorneys throughout the transactions contemplated by this Agreement, and therefore this Agreement shall be construed as if the Parties had drafted it jointly, and no portion of this Agreement shall be construed against the drafting Party by reasons of that Party having drafted the Agreement or a portion hereof. Customer has the full legal right, power, authority and capacity to execute, deliver and perform this Agreement and the transactions contemplated hereby. Customer has full legal right and requisite corporate power, authority and capacity to operate and carry on its business as presently conducted. This Agreement and the transactions contemplated hereby constitute the valid and binding obligations of Customer, enforceable in accordance with their respective terms. This Agreement may be terminated by either party at any time in the exercise of its sole discretion by providing written notice to the other; provided, however, that the expiration or termination of this Agreement, for any reason, shall not release either party from any obligation or liability to the other, including any payment and delivery obligation, that (i) has already accrued hereunder, (ii) comes into effect due to the expiration or termination of this Agreement, or (iii) otherwise survives the expiration or termination of this Agreement. Notwithstanding anything to the contrary, Sections 1, 2, 9, 10, 11.8, 12, 15, 16, 20, 21, and 23 above shall survive any expiration, termination or suspension of the Agreement.