Terms of Use

THIS TERMS OF USE AGREEMENT (the “Agreement”) is entered by and between (“Customer”, “You”, or “Your”) and Acera Innovation, LLC.  Any of the following actions constitute Your agreement, without limitation or qualification, to be bound by, and to comply with, the terms of this Agreement: (i) accepting the terms of this Agreement; (ii) initialization or registration of the Services, either on the telephone, email or other means such as through the Acera website (Acerainnovation.com) or through any of the Acera subdomains or a contracted third-party domains (the Acera website, subdomains, and contracted domains are collectively referred to herein as, the “Site”); or (iii) Your use of the “Affiliate” means any entity which directly or indirectly controls, is controlled by, or is

under common control with the subject entity. “Control,” for the purposes of this definition, means direct or indirect ownership or control of more than 50% of the voting interests for the ”Malicious Code” means viruses, worms, time bombs, Trojan horses and other harmful or malicious code, files, scripts, agents or programs.  ”Service” means the online, Web-based applications and platform provided by Us via Site and/or other designated websites which provide support for the product development and compliance process for medtech firms. ”Reference Library” means the combination of (i) attached documents or website links to documents that Acera includes as part of access to the site, (ii) any and all third party documents You are licensed to access or (iii) any and all self generated documents You or Your ”Users” means individuals who are authorized by You to use the Service, for whom subscriptions to a Service have been purchased, and who have been supplied user identifications and passwords by You (or by Us at Your request). Users may include but are not limited to Your employees, consultants, contractors and agents; or third parties with which You transact Provision of Services. Acera shall make the Services available to You pursuant to this Agreement during a subscription term. You agree that Your purchases hereunder are neither contingent on the delivery of any future functionality or features nor dependent on any oral or written public comments made by Us regarding future User Subscriptions. Unless otherwise specified, (i) Services are purchased as User subscriptions and may be accessed solely by the specified Users, except as otherwise provided by this agreement, (ii) additional User subscriptions may be added during the subscription term at the same pricing as that for the pre-existing subscriptions, prorated for the remainder of the subscription term in effect at the time the additional User subscriptions are added, and (iii) the added User subscriptions shall terminate on the same date as the pre-existing subscriptions. User subscriptions are for designated Users and cannot be shared or used by more than one User but may be reassigned to new Users replacing former Users who no longer require ongoing use of the Services.

Acera shall: (i) provide to You basic support for the Purchased Services at no additional charge, and/or upgraded support if purchased separately, (ii) use commercially reasonable efforts to make the Purchased Services available 24 hours a day, 7 days a week, except for: (a) planned downtime (of which Acera shall give at least 8 hours notice via the Purchased Services and which We shall schedule to the extent practicable during the weekend hours from 6:00 p.m. Central time Friday to 3:00 a.m. Central time Monday), or (b) any unavailability caused by circumstances beyond Our reasonable control, including without limitation, acts of God, acts of government, flood, fire, earthquakes, civil unrest, acts of terror, strikes or other labor problems (other than those involving Our employees), or Internet service provider failures or delays, and (iii) provide the Purchased Services only in accordance with applicable laws and government regulations.

Your Responsibilities.

You shall (i) be responsible for Users’ compliance with this Agreement, (ii) be solely responsible for the accuracy, quality, integrity and legality of Your Data and of the means by which You acquired Your Data, (iii) use commercially reasonable efforts to prevent unauthorized access to or use of the Services, and notify Us promptly of any such unauthorized access or use, and (iv) use the Services only in accordance with the User Guide and applicable laws and government regulations. You shall not (a) make the Services available to anyone other than Users, (b) sell, resell, rent or lease the Services, (c) use the Services to store or transmit infringing, libelous, or otherwise unlawful or tortious material, or to store or transmit material in violation of third-party privacy rights, (d) use the Services to store or transmit Malicious Code, (e) interfere with or disrupt the integrity or performance of the Services or third-party data contained therein, or (f) attempt to gain unauthorized access to the Services or their related Services or networks.

The Service provides information to enable You to monitor your usage of the Service and to monitor compliance with such limitations. Services are subject to following limitations:

3.3.1. Attached Storage Space – Limited to 5 GB

3.3.2. Number of Concurrent Products – No usage limitation

3.3.3. Number of Concurrent Projects – No usage limitation

3.3.4. Number of Concurrent Users – as specified in the User Contract

During the 30 day Trial period there will be no cost for up to three users. If you continue beyond the 30 Trial period, you shall pay fees as specified in the User Contract for all users for twelve month period at which time user fees will be re-established under mutually acceptable terms. Except as otherwise specified herein, (i) fees are quoted in the User Contract and payable in United States dollars (ii) fees are based on services purchased and not actual usage, (iii) payment obligations are non-cancelable and fees paid are non-refundable, and (iv) the number of User subscriptions purchased cannot be decreased during the relevant subscription term stated on the Order Form. User subscription fees are based on monthly periods that begin on the subscription start date and each monthly anniversary thereof; therefore, fees for User subscriptions added in the middle of a monthly period will be charged for that full monthly period and the monthly periods remaining in the

Invoicing and Payment. You will provide Acera with valid and updated information for invoicing purposes, or with a valid purchase order or alternative document reasonably acceptable to Acera. Unless otherwise stated invoiced charges are due net 30 days from the invoice date. You are responsible for maintaining complete and accurate billing and contact information in the Service.

If any charges are not received from You by the due date, then at Acera’s discretion, (a) such charges may accrue late interest at the rate of 1.5% of the outstanding balance per month, or the maximum rate permitted by law, whichever is lower, from the date such payment was due until the date paid, and/or (b) Acera may condition future subscription renewals on payment terms shorter than those specified in Suspension of Service and Acceleration. If any amount owing by You under this or any other agreement for Our Services is 30 or more days overdue (or 10 or more days overdue in the case of amounts You have authorized Acera to charge to Your credit card), Acera may, without limiting our other rights and remedies, accelerate Your unpaid fee obligations under such agreements so that all such obligations become immediately due and payable, and suspend Our Services to You until such amounts are paid in full.

Unless otherwise stated, Acera fees do not include any taxes, levies, duties or similar governmental assessments of any nature, including but not limited to value-added, sales, use or withholding taxes, assessable by any local, state, provincial, federal or foreign jurisdiction (collectively, ” Taxes”). You are responsible for paying all Taxes associated with Your purchases hereunder. If We have the legal obligation to pay or collect Taxes for which You are responsible under this paragraph, the appropriate amount shall be invoiced to and paid by You, unless You provide Acera with a valid tax exemption certificate authorized by the appropriate taxing authority. For clarity, Acera is solely responsible for taxes assessable against it based on Acera income, property and Proprietary Rights.

Subject to the limited rights expressly granted hereunder,  We reserve all rights, title and interest in and to the Acera Service, including all related intellectual property rights. No rights are granted to You hereunder other than as Restrictions. You shall not (i) permit any third party to access the Service except as permitted herein, (ii) create derivative works based on the Service, (iii) copy, frame or mirror any part or content of the Service, (iv) reverse engineer the Service, or (v) access the Service in order to (a) build a competitive Service or service, or (b) copy any features, functions or graphics of the Service.

Ownership of Your Data.

As between Acera and You, You exclusively own all rights, title and interest in and to all of Your Data. Your Data may be exported at your discretion, by You at anytime to industry standard formats.

Confidentiality of Your Data. As between Acera and You, Acera agrees to hold any confidential data shared with Acera. We shall have a royalty-free, worldwide, transferable, sublicenseable, irrevocable, perpetual license to use or incorporate into the Service any suggestions, enhancement requests, recommendations or other feedback provided by You, including Users, relating to the operation of the Services.

We warrant that (i) the Service shall perform materially in accordance with the Demonstration and/or User Guide, and (ii) the functionality of the Services will not be materially decreased during a subscription term. For any breach of either such warranty, Your exclusive remedy shall be as provided in Section 8 below. Mutual Warranties. Each party represents and warrants that (i) it has the legal

power to enter into this Agreement, and (ii) it will not transmit to the other party any Malicious Code (except for Malicious Code previously transmitted to the warranting Disclaimer. EXCEPT AS EXPRESSLY PROVIDED HEREIN, NEITHER PARTY MAKES ANY WARRANTIES OF ANY KIND, WHETHER EXPRESS, IMPLIED, STATUTORY OR OTHERWISE, AND EACH PARTY SPECIFICALLY DISCLAIMS ALL IMPLIED WARRANTIES, INCLUDING ANY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW. THIS AGREEMENT DOES NOT PROVIDE ANY IMPLIED OR INFERRED ASSURANCE OF REGULATORY COMPLIANCE. COMPLIANCE AND LIABILITY IS THE ULTIMATE RESPONSIBILITY OF THE USER.

Termination.

This Agreement shall continue in full force and effect until terminated by either party upon 30 days written notice to the other party, except that, upon breach of this Agreement by Customer or a User, Acera shall be entitled to immediately terminate the Agreement without further obligation to Customer.  Limitations of Liability. Customer’s exclusive remedy for any defaults by Acera under this Agreement shall be the refund of the amount paid under this Agreement. IN NO EVENT SHALL ACERA BE LIABLE FOR ANY LOSS OF PROFITS, INCIDENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES, OR ANY CLAIMS OR DEMANDS BROUGHT AGAINST CUSTOMER, EVEN IF ACERA HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH CLAIMS OR DEMANDS. THIS LIMITATION OF LIABILITY IS INTENDED TO APPLY WITHOUT REGARD TO WHETHER OTHER PROVISIONS OF THIS AGREEMENT HAVE BEEN BREACHED OR HAVE PROVEN Relationship Between Parties. Acera shall be an independent contractor and not an employee, affiliate or agent of Customer. Such status shall govern all relations between Customer and Acera under this Agreement. The manner in which Acera renders its Services under this Agreement shall be within the sole control and the sole discretion of Acera.

Customer will comply with all applicable federal, state and local laws. By signing this Agreement, Customer is providing its written confirmation and assurance that no proprietary information supplied by Acera, nor the direct Service thereof, will be provided to any third party countries or nationals thereof unless authorized in writing by Acera and the applicable United States of America export control laws or regulations, including, but not limited to the U.S. Export Administration Regulations.

Acera assumes no liability to Customer or to third parties with respect to the performance characteristics of the Service, and Customer hereby agrees to indemnify and hold Acera harmless from and against all losses, damages and expenses, including attorneys’ fees, incurred as a result of or related to claims of third persons involving the performance of the Service. Customer will further indemnify and hold Acera harmless from and against all actions arising out of a breach by Customer of this Agreement.

If an action is brought by Acera against Customer for any default under this Agreement, Acera shall be entitled to recover, in addition to any other relief granted, reasonable attorney fees and expenses of litigation.

The parties shall endeavor to settle disputes by arbitration in accordance with the rules of the American Arbitration Association currently in effect. Demand for arbitration shall be filed in writing with the other party to this Agreement and with the American Arbitration Association. A demand for arbitration shall be made within a reasonable time after the claim, dispute or other matter in question has arisen. The parties shall share the arbitrator’s fee and any filing fees equally.

Customer may not transfer, lease, assign or sublicense its rights under this Agreement.

Entire Agreement. This Agreement contains the entire agreement between Partner and the Acera with respect to the subject matter hereof. All prior agreement and understandings are superseded by this Agreement.

No provision of this Agreement may be modified, waived, terminated or amended except by a written instrument executed by the parties hereto. No waiver of a breach of any provision of this Agreement shall constitute a waiver of any subsequent breach of the same or other provisions hereof.

Any notices or demands or other communications required or permitted hereunder shall be in writing and shall be deemed to have been given when delivered personally or 3 days after deposit in a regularly maintained receptacle of the United States Postal Service, postage prepaid, return receipt requested and addressed as follows or as the parties may from time to time designate in writing:  To the address specified by the Customer

Acera Innovation, LLC

3515 Plymouth Boulevard, Suite 205

Minneapolis, MN 55447

All provisions of this Agreement, as necessary or appropriate, shall survive the expiration or termination of this Agreement.

The provisions of this Agreement shall be interpreted and construed in accordance with the laws of the State of Minnesota and the United States of America in any dispute arising out of this Agreement.

If any provision of this Agreement is prohibited by law or held to be invalid, illegal, or unenforceable, the remaining provisions hereof shall not be affected, and this Agreement shall continue in full force and effect as if such prohibited, illegal or invalid provision had never constituted a part hereof, with this Agreement being enforced to the fullest extent possible. This Agreement shall not be construed against the party preparing it, but shall be construed as if both parties jointly prepared it and any uncertainty or ambiguity shall not be interpreted against either party.