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NOVA LEAH

SOFTWARE TERMS & CONDITIONS FOR MEDICAL DEVICE MANUFACTURERS V1

Welcome to Nova Leah (“Nova Leah”, “We”, “Us” or “Our”) and our Terms of Service (“Terms”). We have created a number of cybersecurity risk management solutions for medical device manufacturers and healthcare delivery organisations including SelectEvidence™ and SelectEvaluate™ (“Services”) available to users (“Users”, “You”, “Your” each of which includes your employees, agents and representatives) of our platform selectevaluate.com/selectevidence.com and related Nova Leah software, tools, applications and/or APIs (“Platform”).

For information we are Nova Leah Limited, a company incorporated in Ireland with registration number 558845 and headquartered at Building 3, Finnabair Industrial Estate, Dundalk, Co. Louth, Ireland.

1. USE OF THE WEBSITE

1.1 Please read these Terms carefully before using the Platform and our services. By using the Services and/or accessing, or using the Platform, you are accepting these Terms (on behalf of yourself or the entity that you represent) and you represent and warrant that you have the right, authority, and capacity to enter into these Terms (on behalf of yourself or the entity that you represent). You confirm that you are of sufficient age to lawfully use the Platform and Services, enter into a contract and to create binding legal obligations for any liability you may incur as a result of your use of the Platform and Services. If you do not agree to these Terms, please do not use the Platform or Services.

1.2 A hyperlink to these Terms is prominently displayed at the bottom of the Platform homepage https://www.novaleah.com/legal/.

1.3 We reserve the right in our sole discretion and at any time and for any reason, to modify, suspend or discontinue any aspect or feature of the Platform and Services or to modify these Terms. Please note that the Terms may vary from time to time and that your continued use of the Platform and/or Services following such change constitutes your acceptance of the new Terms. Material changes shall be notified via the Platform. You agree that Nova Leah will not be liable to you or to any third party for any modification, suspension, or discontinuation of the Platform and Services or any part thereof.

1.4 When you use the Platform and Services or send e-mails to us, you are communicating with us electronically. We will communicate with you by e-mail or by posting notices on the Platform. For contractual purposes, you consent to receive communications from us electronically and you agree that all agreements, notices, disclosures, and other communications that we provide to you electronically satisfy any legal requirement that such communications be in writing, unless mandatory applicable laws specifically require a different form of communication.

2. ACCOUNT REGISTRATION

2.1 To use the Services or features on the Platform, you may need to apply and provide various details. We will then contact you to verify your application and once verified you will then be provided with credentials to your account. Only registered Users are authorized to access the restricted portions of the Platform. As part of the registration process, you will create a username and password. Your username will be your e-mail address. The User will ensure their employees, representatives or agents have unique login details. You must ensure that you keep your username and password secure with passwords changed regularly and that you do not disclose them to anyone as you will be fully responsible for all activities which occur under your username and password. Furthermore, the User acknowledges that sharing user logins will be deemed a material breach of these Terms which is not capable of remedy. All Users seeking to set up an account must be human, and we strictly forbid any use of bots, scripts, etc. with the Platform or Services.

2.2 You agree to provide current, truthful, accurate and complete information when you register with, and as you use, the Services and Platform (“Registration Data”) in order to allow Nova Leah to provide the Services and retain records relating to same and to this end, you agree to update your Registration Data to keep it accurate and complete. You agree that Nova Leah may store and use the Registration Data you provide for use in maintaining your account and in accordance with our privacy policy.

2.3 It is your responsibility to immediately notify us of any unauthorized use of your username and password or any other breach of security as soon as you become aware of it. You shall be responsible for the acts and omissions of any of your employees, agents or representatives who access the Services, as though they were your acts and omissions. You agree to indemnify and hold us harmless against any claims, costs, losses, damages, or liability arising from the acts or omissions of employees, agents or representatives.

3. PREMIUM ACCESS & FEES

3.1 We offer our Services on a free or premium access basis. Under premium access, fees may arise on a pay-as-you-go or fixed term commitment model (“Subscription”). Fees incurred on your account shall be in accordance with the then current fee schedule for the relevant Services.

3.2 You agree to provide valid payment details and to pay all applicable fees as they arise. Failure to pay these fees may result in the termination of your account. Fees will be billed and paid in accordance with the payment terms agreed on your account.

3.3 Depending on the Subscription, your payment method will be automatically charged at the start of each subscription period for the fees and taxes applicable to that period. To avoid future charges, cancel before the renewal date in accordance with these Terms.

3.4 Downgrading your Account may cause the loss of content or features available to you at your current access, but we are not, and will not be held to be, liable for such loss.

3.5 If your payment method expires or changes, and you do not edit or update your payment information or cancel your account, we will send you a single courtesy notice regarding payment information discrepancies. If you fail to provide us with updated payment information more than three (3) days after notice is sent, we reserve the right to disable and terminate access to your account. You authorize us to continue billing during this notice period, and you will remain responsible for any uncollected amounts.

3.6 If you decide to cancel your Subscription, you will still have access to your Subscription until the day of expiration and will be charged accordingly. For SelectEvaluate your account will continue on a free access basis.

4. SUPPORT

4.1 You may contact Nova Leah in relation to any question in respect of the usage of the Platform by contacting Support through the helpdesk widget.

4.2 From time to time, it may be necessary for Nova Leah to complete maintenance on the Platform. If the maintenance is likely to result in unavailability of the Services, then Nova Leah will endeavor to advise Users in advance by posting a notice on the Platform. Unscheduled maintenance in respect of a significant event may be required to be performed at any time without notice.

5. RESTRICTION OF ACCESS AND TERMINATION ​​​ ​

5.1 We reserve the right in our sole discretion (acting reasonably) and at any time to terminate, restrict or suspend your access to the Platform and Services for any reason including, without limitation, if you have failed to comply with these Terms. You agree that Nova Leah shall not be liable to you or any third party for any termination or suspension of your account or for blocking your access to the Platform and Services. Upon termination, your right to use the Platform and Services will immediately cease and you shall discharge all amounts due and owing by you up to the date of termination. If you wish to terminate your account, you may follow the instructions on your account to do so.

5.2 Any restriction or suspension shall not affect your obligations to us under these Terms and shall be without prejudice to any accrued rights of either Party. The provisions of these Terms which by their nature should survive the suspension or restriction shall survive including, but not limited to the provisions on intellectual property rights, acceptable use terms, disclaimers, indemnity, limitations on liability, confidentiality, and all of the General provisions in these Terms.

6. INTELLECTUAL PROPERTY RIGHTS AND CONTENT

6.1 The Platform contains information, including, without limitation, all text, graphics, photographs, graphs, designs, sounds, data, images, audio, video, page layouts and headers, software (including HTML and other scripts), buttons, and other icons, trademarks and the arrangement and compilation of this information (collectively, the “Information”) that is either owned or licensed by Nova Leah.

6.2 You acknowledge and agree that Nova Leah and/or its licensors own all Information and all Intellectual Property Rights in the Services and the Platform. Except as expressly stated herein, these Terms do not grant you any rights to, under or in, any patents, copyright, database right, trade secrets, trade names, trademarks (whether registered or unregistered), or any other rights or licenses in respect of the Platform or Services.

6.3 As between the parties you own all right, title and interest in and to all of the User Data and shall have sole responsibility for the legality, reliability, integrity, accuracy and quality of all such User Data. Nova Leah may store and use User Data as necessary to provide, develop, maintain, and improve the Services, comply with applicable law, and enforce our policies and you grant us a non-exclusive, worldwide, royalty free, irrevocable license to use User Data for these purposes.

6.4 You expressly represent and warrant to us:

(i) your User Data is yours or you have the right to use it and to grant us the limited rights and licence as provided in these Terms in order to perform the Services; and

(ii) your uploading of User Data to the Services does not violate the privacy rights, publicity rights, Intellectual Property Rights, contract rights, consent rights, or any other rights of any person.

6.5 Our Services allow you to upload certain documentation in respect of your products to include: (i) publicly available product baseline information such as marketing collateral and user instructions (“Base Line Information”); and (ii) confidential product information such as software bill of materials (SBOMs), data flow diagrams (DFDs), and manufacturer discloser statements (MSD2) (“Product Information”). Your Base Line Information together with Product Information is “User Data” Depending on the Services, Base Line Information may be made available to healthcare delivery organizations through their use of the Services (“HDOs”). In addition, HDOs may request authorization from you through the Services to access your Product Information. Once you authorize a healthcare provider’s request for access to your Product Information, this will be shared with them through the Service.

6.6 You acknowledge that Nova Leah is not responsible for the conduct or activities of any of the Users of the Services, including but not limited to any HDOs who you may interact with in using the Services and that the Company is not liable for such under any circumstances. You shall be solely responsible for all interactions with such HDOS. You acknowledge that any disputes, claims, or proceedings arising out of or related to the interactions with HDOS and the sharing of User Data with them shall be pursued solely and exclusively between you and the HDOs. You shall defend, indemnify, and hold Nova Leah, its affiliates, officers, agents and other partners and employees, harmless from any claims, demands, actions, losses, liabilities, costs, damages, or expenses, (including any professional and legal fees incurred in connection therewith) arising out of or related in any way to any disputes, claims or proceedings between you and HDOs.

6.7 You can remove your own User Data by specifically deleting it. We are not responsible or liable for the removal or deletion of (or the failure to remove or delete) any of the User Data.

6.8 We welcome feedback, comments, and suggestions for improvements to the Services. You can submit feedback by emailing us at techsupportcsm@novaleah.com. You grant us a non-exclusive, worldwide, perpetual, irrevocable, fully paid, royalty-free, sublicensable, and transferable license to use, copy, modify, create derivative works based upon and otherwise exploit the feedback for any purpose.

6.9 For the purposes of these Terms, when we refer to “Intellectual Property” we mean patents, trademarks, service marks, rights (registered or unregistered) in any designs, applications for any of the foregoing, trade or business names, copyright (including rights in computer software), secret formulae and processes, other proprietary knowledge and information, internet domain names, rights protecting goodwill and reputation, database rights (including rights of extraction) and all rights and forms of protection of a similar nature to any of the foregoing or having equivalent effect anywhere in the world and all rights under licenses and consents in respect of any of the rights and forms of protection mentioned in this definition (and “Intellectual Property Rights” shall be construed accordingly).

7. ACCEPTABLE USE TERMS

7.1 Nova Leah grants you a limited, revocable, non-exclusive, and non-transferable right to access the Platform and use the Services, subject to these Terms.

7.2 Unless separately and specifically authorized in writing by Nova Leah and save as otherwise provided for herein, you may not sell, rent, lease, license, sublicence, distribute, transfer, copy, reproduce, publicly display, publish, adapt, modify, create derivative works, print, assign, host, download store or time-share the Platform, Services, Information, or any part thereof.

7.3 Furthermore, except as expressly permitted in these terms, you may not: (i) remove, alter, cover, or distort any copyright, trademark, or other proprietary rights notice on the Platform, Services or Information; (ii) circumvent, disable or otherwise interfere with security-related features of the Platform and Services; (iii) use an automatic device (such as a robot or spider) or manual process to copy or “scrape” the Platform, Services or Information for any purpose without our express written permission; (iv) collect or harvest any personal data or personally identifiable information from the Platform and Services including, without limitation, user names, passwords, email addresses; (v) attempt to or interfere with the proper working of the Platform and Services or impair, overburden, or disable the same; (vi) decompile, reverse engineer, or disassemble any portion of the Platform and Services; (vii) use network-monitoring software to determine architecture of or extract usage data from the Platform and Services; (viii) encourage conduct that violates any local, state, federal law or international law, impersonate others, use a false email address, or misrepresent your affiliation with others; (ix) access the Platform or use the Services in order to build a similar or competitive website, product, or service, (x) use the Platform and Services to send unsolicited or unauthorized advertising, promotional, marketing or other spam communications, or (xi) engage in any conduct that restricts or inhibits any other user from using or enjoying the Platform and Services.

7.4 You agree to use the Platform and Services for lawful purposes only. When using the Platform and Services, you agree to comply with all applicable federal, state, and local laws, including, without limitation, copyright law. You agree not to collect, upload, display, distribute post or transmit any information through the Platform or associated websites or use the Services in any which: (a) infringes or violates our Intellectual Property Rights, or infringes or violates the rights of others including but not limited to their, intellectual property, privacy or publicity rights, (b) is unlawful, threatening, abusive, defamatory, discriminatory, libelous, false or misleading, vulgar, obscene, pornographic, harmful to minors in any way, profane, indecent or otherwise objectionable, (c) is protected by copyright, trademark or other proprietary right without express written permission of the owner of such right, (d) contains unauthorized or malicious software such as viruses. You shall be solely liable for any damages resulting from your infringement of any copyright, trademark or other proprietary right, or any other harm caused by your use of the Platform, Services, or Information.

7.5 Platform may contain links to third-party websites and services (collectively, “Third-Party Links”). We have no control over, and assume no responsibility for, the content, privacy policies, or practices of any such third-party websites or their services. Nova Leah provides access to these Third-Party Links only as a convenience to you, and does not review, approve, monitor, endorse, warrant, or make any representations with respect to Third-Party Links. You use all Third-Party Links at your own risk and should apply a suitable level of caution and discretion in doing so. We strongly advise you to read the terms and conditions and privacy policies of any third-party websites that you visit.

8. INDEMNITY

You agree to defend, indemnify and hold Nova Leah, its affiliates, officers, agents and other partners and employees, harmless from any claims, demands, actions, losses, liabilities, costs, damages or expenses, (including any professional and legal fees incurred in connection therewith), to the extent allowed by applicable law, that arise from or are caused by: (i) your use of and access to the Platform and Services; (ii) your breach of these Terms; (iii) your violation of any third party right, including without limitation any proprietary, trademark, copyright, property, moral or privacy right; or (iv) any claim that your User Data caused damage to any third party. We reserve the right, at the User’s expense, to assume the exclusive defense and control of any matter for which the User is required to indemnify us.

9. LIMITATION OF LIABILITY

9.1 Nothing in these Terms limits or excludes liability of either party in respect of any claims for death or personal injury caused by negligence, fraud or any other liability which cannot be excluded or limited by law.

9.2 To the maximum extent permitted by applicable law, Nova Leah will not have any liability to you for any loss of profits, loss of business, loss of data, loss of use, loss of goodwill, or for any indirect, special, incidental, punitive, or consequential damages of any kind however caused and under any theory of liability whether or not Nova Leah has been advised of the possibility of such.

9.3 Subject to sections 9.1 and 9.2, in no event whatsoever shall the maximum aggregate liability of Nova Leah, whether arising for breach of contract, misrepresentation (whether tortuous or statutory), tort (including negligence), breach of statutory duty, warranty, strict liability or any other legal theory howsoever arising, under or in connection with these Terms exceed THE TOTAL AMOUNTS ACTUALLY PAID TO COMPANY FOR THE SERVICES IN THE THREE (3) MONTH PERIOD IMMEDIATELY PRECEDING THE EVENT GIVING RISE TO SUCH CLAIM UP TO A MAXIMUM AMOUNT OF €1,000, OR ONE HUNDRED DOLLARS (€100), IF YOU HAVE NOT HAD ANY PAYMENT OBLIGATIONS TO NOVA LEAH, AS APPLICABLE.

10. DISCLAIMER

10.1 Use and access to the Services and Platform requires: (i) compatible devices; (ii) internet access; (iii) certain software (for which fees may apply); (iv) may require periodic updates; and (v) may be affected by the performance of these factors. High-speed internet access is strongly recommended for regular use and is required for video. The latest version of required software is recommended to access the Platform and may be required for certain transactions or features. You agree that meeting these requirements, which may change from time to time, is your responsibility.

10.2 You acknowledge and agree that no warranties of any kind are made with respect to the Platform, Services or information and you acknowledge that the Platform, Services, and Information are provided to you on an “as is, with all faults” basis. All warranties, conditions and other terms implied by statute or common law are, to the fullest extent permitted by law, excluded from these Terms.

10.3 Nova Leah does not guarantee, represent, or warrant that your use of the Platform and Services will be uninterrupted or error-free and you agree that from time-to-time Nova Leah may prevent access to the Platform and Services for indefinite periods of time, without notice to you. No warranty is made that the Platform and Services will meet your requirements.

11. PERSONAL DATA

The use of the Platform is subject to Nova Leah’s Privacy Policy at https://www.novaleah.com/legal in respect of any personal data we may process as a result of your use of the Platform and Services.

12. CONFIDENTIALITY 

12.1 Each party agrees and undertakes that while using the Platform and Services it shall keep confidential and shall not use for its own purposes, nor without the prior written consent of the other party disclose to any third party, all information of a confidential nature (including, without limitation, information relating to a party’s products, operations, processes, plans or intentions, product information, know-how, design rights, trade secrets and information of commercial value) which may become known to that party from the other party (“Confidential Information”), unless the information is public knowledge or already known to that party at the time of disclosure or subsequently becomes public knowledge other than by breach of these Terms or subsequently comes lawfully into the possession of that party from a third party.

12.2 To the extent necessary to implement the provisions of these Terms, ​​​​each party may disclose Confidential Information to those of its employees​ and contractors​ as may be reasonably necessary or desirable, provided that before any such disclosure each party shall make those employees​ and contractors​ aware of its obligations of confidentiality under these Terms and shall at all times procure compliance by those employees ​and contractors ​with them.

13. GENERAL

13.1 The failure or delay by a party to exercise or enforce any rights hereunder shall not be deemed to be a waiver of any such right nor operate so as to bar the exercise or enforcement thereof at time or times thereafter.

13.2 If any provision (or part of a provision) of these Terms is found by any court or administrative body of competent jurisdiction to be invalid, unenforceable or illegal, the other provisions shall remain in force. If any invalid, unenforceable or illegal provision would be valid, enforceable or legal if some part of it were deleted, the provision shall apply with whatever modification is necessary to give effect to the commercial intention of the parties.

13.3 Unless otherwise expressly provided, no provision of these Terms is intended or shall be construed to confer upon or give to any person or entity other than Nova Leah and you any rights, remedies or other benefits under or by reason of these Terms.

13.4 The headings used in these Terms are for convenience only and shall not affect the meaning or scope of these Terms or otherwise be given other legal effect.

13.5 You agree that Nova Leah shall carry no responsibility for non-fulfilment or delayed fulfilment of the Services owing to a force majeure event, including but not limited to, war, acts of terrorism, riots, civil unrest, intervention by government or public authorities, fire, strike or lock-out, export and/or import bans, failure in telecommunications services and networks, shortage of labor, fuel or power, pandemic, epidemic or any other cause beyond our control which may delay or impede the Services.

13.6 You agree that no joint venture, partnership, employment, or agency relationship exists between you and Nova Leah as a result of these Terms or your use of this Platform.

13.7 Nova Leah Privacy Policy as accessed through the Platform shall form part of these Terms.

13.8 These Terms and any dispute or claim arising out of, or in connection with, it, its subject matter or formation (including non-contractual disputes or claims) shall be governed by, and construed in accordance with, the laws of Ireland. The parties irrevocably agree that the courts of Ireland shall have exclusive jurisdiction to settle any dispute or claim arising out of, or in connection with, these Terms, its subject matter or formation (including non-contractual disputes or claims).