Randomize.net Terms and Conditions and License Agreement

These Terms are between Interrand Inc., its successors and assignees, (referred to as we, us or our), and you, the person, entity or organisation engaging us to perform our Services (referred to as you or your), and collectively the Parties. You have requested our Services. You agree and accept that these terms and conditions (Terms):

• form the agreement under which we will supply the Services to you;
• govern your access to and use of our Software and any of our related materials, media or services made available to you, including, but not limited to any hosting or provision of a cloud-based environment and any related support services.

Your access to the Services is subject to your purchase or licence of the applicable products created by Interrand Inc.

1. Acceptance

1. You accept these Terms by:
   1. clicking the “Create Coordinating Center” or equivalent buttons for our Services, or
   2. confirming by email that you accept the Terms.
2. You warrant that by accessing/using the Services:
   1. you have reviewed and accepted these Terms;
   2. you have the legal capacity to enter into a legally binding agreement;
   3. you have reviewed our DPA, if the processing of any Company Personal Data is governed by the GDPR;
   4. you have authority to act on behalf of any person or entity for whom you are using the Services, and you are deemed to have agreed to these Terms on behalf of any entity for whom you are using the Services; and
   5. you have all hardware, software, software licences and services which are necessary to access and use the Services.
3. The supply of the Services relies on products and services supplied by third parties including, but not limited to third party infrastructure and services or products provided by AWS. Where any other third party terms apply, we will use reasonable endeavours to notify you of such terms.
4. You acknowledge and agree that in collecting, holding and processing Company Personal Data through the Services, we are acting as the data processor for the purposes of the GDPR. If the GDPR applies, the additional terms in the DPA also form part of these Terms. You must obtain all necessary consents from the relevant individual to enable us to collect, use, hold and process Company Personal Data in accordance with these Terms and, if applicable, the DPA.

2. Accessing the Services

1. To access the Services, you must:
   1. Provide details including name, contact details and other related information as reasonably required to enable us to supply you with access to the Services; and
   2. Provide payment for any non-test clinical trials activated. The Fees will vary subject to your purchased Software, Subscription and/or the functionalities and Services you request as identified on the Invoice.
2. Following your submission of a clinical trial activation, and our receipt of the applicable Fees, you will obtain a licence (Licence), in order for you, your Authorised Users or your organisation to access and use the Services. You are responsible for determining:
   1. who will be an Authorised User;
   2. each Authorised User’s access level; and
   3. whether to revoke an Authorised User’s access to the Services at any time for any reason.
3. You Order will specify your authorised scope of use for the Services, which may include:
   1. the defined number of clinical trial, the number of clinical sites, the number of Authorised Users provided with access, the number randomized subjects you may enroll, and/or other defined resource utilisation limitations,
   2. other restrictions or billable units (together the Scope of Use).
4. The term “Order” also includes any applicable renewal, or purchases you make to upgrade your Scope of Use.
5. You agree that we are a software as a service provider and we are not responsible for the management or administration of all the hardware, software, software licences and services which are necessary to access and use the Services.

3. Our Software

We own the Software which is accessible as a cloud-based service at www.randomize.net

4. Cloud-Based Services Terms

Cloud-Based Services Licence

1. In consideration for payment of the Fees for Cloud-Based Services, we grant you a non-exclusive, non-transferable, non-sub-licensable (except as otherwise permitted under these Terms), revocable licence to access and use the Cloud-Based Services for business purposes for the subscription term and for the number of Authorised Users as set out in the Order (Cloud-Based Services).

5. Payment

Fees

1. You agree to pay the applicable Fees, directly to Interrand Inc. as required, to enable you to access or install the Cloud-Based Services, without set off or delay using one of the payment methods available as specified in the order. Payment of such amounts will be in accordance with the applicable Interrand Inc. terms.
2. he Fees payable for the Services will vary subject to your Subscription and/or the functionalities and Services you request as identified in the Order.
3. Our pricing structure or payment methods may be amended from time to time at our sole discretion.

6. Restrictions

1. You must not (and must ensure your Authorised Users do not) access or use the SaaS Services except as permitted by the Licence for Cloud-Based Services, as applicable, and you must not and must not permit any other person to:
   1. use the SaaS Services in any way which is in breach of any applicable Laws or which infringes any person’s rights, including Intellectual Property rights;
   2. use the SaaS Services to transmit, publish or communicate material that is defamatory, offensive, abusive, indecent, menacing or unwanted;
   3. use the SaaS Services in any way that damages, interferes with or interrupts the supply of the SaaS Services;
   4. introduce malicious programs into our hardware or software or Systems, including viruses, worms, trojan horses and e-mail bombs;
   5. use the SaaS Services to carry out security breaches or disruptions of a network. Security breaches include accessing data when you are not the intended recipient or logging into a server or account that you are not expressly authorised to access, or corrupting any data (including network sniffing/monitoring, pinged floods, packet spoofing, denial of service and forged routing information for malicious purposes);
   6. use any program/script/command, or send messages of any kind, with the intent to interfere with, or disable, any person’s use of the SaaS Services;
   7. use the SaaS Services to circumvent user authentication or security of any of your networks, accounts or hosts or those of your customers or suppliers.

7. Third Parties

1. You acknowledge and agree that:
   1. the provision of the Services may be contingent on, or impacted by, third parties, end users, suppliers, other subcontractors (Third Party Inputs); and
   2. despite anything to the contrary, to the maximum extent permitted by law, we will not be responsible for, and will have no Liability for, any default or breach of these Terms or law, if such default or breach was caused by or contributed to by any Third Party Inputs.
2. You acknowledge that the SaaS Services include certain optional functionality that may interface with third party software or services. To the extent that you choose to use such functionality, you are responsible for: (i) the purchase of, (ii) the ancillary requirements related to, and (iii) the licensing obligations related to the applicable third party software and services. It is your responsibility to ensure the requirements are met in order for you to benefit from the specific functionality made available to you.
3. This clause will survive the termination or expiry of these Terms.

8. Support Services

1. Support Services and any Updates are provided in accordance with our Maintenance and Support Policy, Service Level Agreement and are subject to you having a valid support entitlement and support entitlement number, as defined in the applicable Interrand Inc. Terms.

9. Privacy

1. You acknowledge and agree that you are responsible for the collection, use, storage and otherwise dealing with Personal Information related to your business and all matters relating to the Data.
2. You will comply and ensure that all of your Personnel and Authorised Users comply with the requirements of applicable Privacy Laws in respect to all Personal Information collected, used, stored or otherwise dealt with under or in connection with these Terms.
3. Without limiting clause 10(1), you must:
   1. notify your Authorised Users, Personnel, or other natural persons from whom Personal Information is collected about any matter prescribed by Privacy Law in relation to the collection, use and storage of their Personal Information;
   2. ensure that any Personal Information transferred to us is complete, accurate and up to date; and
   3. notify us immediately upon becoming aware of any breach of Privacy Law that may be related to the use of the Personal Information under these Terms.
4. Without limiting clause 10(1), you may only disclose Personal Information in your control to us if:
   1. you are authorised by Privacy Law to collect the Personal Information and to use or disclose it in the manner required by these Terms; and
   2. where any Personal Information is Sensitive Information, you have obtained the specific consent to that disclosure from the individual to whom the Sensitive Information relates.

10. Warranties

1. You warrant and agree that:
   1. there are no legal restrictions preventing you from agreeing to these Terms;
   2. you will cooperate with us and provide us with all assistance, information and data that is reasonably necessary to enable us to perform the Services, and as otherwise requested by us, from time to time, and in a timely manner;
   3. all information and documentation that you provide to us in connection with these Terms is true, correct and complete and you acknowledge and agree that we will rely on such information and documentation in order to provide the Services;
   4. you will inform us if you have reasonable concerns relating to our provision of Services under these Terms, with the aim that the Parties will use all reasonable efforts to resolve your concerns;
   5. you are responsible for obtaining any consents, licences, authorities and permissions from other parties necessary for the Services to be provided in accordance with these Terms, at your cost, and for providing us with the necessary consents, licences, authorities and permissions; and
   6. you will maintain the confidentiality and security of any of your Licence details.

11. Intellectual Property Rights

1. Our Intellectual Property

1. All Intellectual Property developed, adapted, modified or created by us or our Personnel, expect with regards to any template forms (including in connection with these Terms, the Software and the Services) is and will remain owned exclusively by us or our third party service providers.

2. You must not, without our prior written consent:

   1. copy or use, in whole or in part, any of our Intellectual Property;
   2. reproduce, retransmit, distribute, disseminate, sell, publish, broadcast or circulate any of our Intellectual Property to any third party;
   3. reverse assemble, reverse engineer, reverse compile or enhance the SaaS Services;
   4. breach any Intellectual Property Rights connected with the Software or the Services, including altering or modifying any of our Intellectual Property;
   5. create derivative works from any of our Intellectual Property;
   6. resell, assign, transfer, distribute or make available the SaaS Services to third parties;
   7. alter, remove or tamper with any trademarks, any patent or copyright notices, any confidentiality legend or notice, any numbers or any other means of identification used on or in relation to the SaaS Services or Software;

3. Notwithstanding anything to the contrary in these Terms or elsewhere, we may monitor, analyse and compile statistical and performance information based on and/or related to your use of the Services, in an aggregated and anonymised format (Analytics). You agree that we may make such Analytics publicly available, provided that the Analytics:

   1. do not contain identifying information; and
   2. are not compiled using a sample size small enough to make the underlying data identifiable.

4. We and/or our licensors own all right, title and interest in and to the Analytics and all related software, technology, documentation and content provided in connection with the Analytics, including all Intellectual Property rights in the foregoing.

2. Your Intellectual Property

1. As between you and us, (i) all Data is and remains your property, and (ii) you retain any and all rights, title and interest in and to the Data, including all copies, modifications, extensions and derivative works thereof.
2. IP Licence: You grant us a limited licence to copy, transmit, store and back-up or otherwise access the Data, as applicable, solely to:
   1. supply the Services to you (including to enable you and your Personnel to access and use the Services);
   2. diagnose problems with the SaaS Services;
   3. enhance and otherwise modify the Services;
   4. develop other services, provided we de-identify the Data; and
   5. as reasonably required to perform our obligations under these Terms.
3. General: You must, at all times, ensure the integrity of the Data and that your use of the Data is compliant with all Laws. You represent and warrant that: (i) you have obtained all necessary rights, releases and permissions to provide all your Data to us and to grant the rights granted to us in these Terms; and (ii) the Data and your transfer to and use by us, as authorised by you under these Terms does not violate any Laws (including those relating to export control and electronic communications) or rights of any third party, including any Intellectual Property rights, rights of privacy, or rights of publicity, and any use, collection and disclosure authorised in these Terms is not inconsistent with the terms of any applicable privacy policies.
4. We assume no responsibility or Liability for the Data. You are solely responsible for the Data and the consequences of using, disclosing, storing or transmitting it.
5. This clause will survive termination or expiry of these Terms.

12. Service Availability

1. While we intend that the SaaS Services should be available 24 hours a day, seven days a week, it is possible that on occasions the SaaS Services or Site may be unavailable to permit maintenance or other development activity to take place.
2. If for any reason we need to interrupt the SaaS Services for longer periods than we would normally expect, we will use reasonable endeavours to publish in advance details of such activity on the Site.

13. Confidential Information

1. Each Party (Recipient) must keep confidential, and not disclose, any Confidential Information of the other party (Discloser) except:

   1. where permitted by these Terms;
   2. with the prior written consent of the Discloser;
   3. where the Confidential Information is received from a third party, except where there has been a breach of confidence;
   4. n a confidential, “need to know” basis to the Recipient’s Personnel, auditors, insurers, agents and professional advisors; or
   5. where the Recipient is compelled to do so by Law, provided that it gives the other party written notice prior to disclosure.

2. The Recipient must only use the Confidential Information of the Discloser for the purpose for which it was disclosed and in connection with these Terms.

3. This clause will survive termination or expiry of these Terms.

14. Liability

1. Despite anything to the contrary, to the maximum extent permitted by law:
   1. our maximum aggregate Liability arising from or in connection with these Terms (including the Services or the subject matter of these Terms) will be limited to, and must not exceed the total amount of Fees you paid to us in the year in which the liability arose (as applicable), or if no Fees were paid in which the liability arose, $0; and
   2. we will not be liable to you for any Consequential Loss, whether under statute, contract, equity, tort (including negligence), indemnity or otherwise.
2. Despite anything to the contrary, to the maximum extent permitted by law, we will have no Liability, and you waive and release us from and against, all Liability (whether under statute, contract, negligence or other tort, indemnity, or otherwise) arising from or in connection with any:
   1. loss of, or damage to, any property or any injury to or loss to any person;
   2. failure or delay in providing the Services; or
   3. breach of these Terms or any Laws,
   4. where caused or contributed to by any:
      1. event or circumstance beyond our reasonable control;
      2. a fault, defect, error or omission in your Computing Environment or Data; or
      3. act or omission by you, your related parties, Authorised Users, Personnel or any third party (including customers, end users, suppliers, providers or subcontractors),
   5. and, in any event, any error, omission or lack of suitability (or the absence of, or reduction in, any anticipated result, outcome or benefit) with respect to the Services.
3. To the maximum extent permitted by law, you indemnify and continue to indemnify us against all Liability we suffer or incur arising from or as a consequence of a breach of clause 10(Privacy), clause 12(Intellectual Property) or from any claim relating to the Data.
4. You acknowledge and agree that:
   1. you are responsible for all users using the Services, including your Personnel and any Authorised Users;
   2. you use the Services and any associated programs and files at your own risk;
   3. the technical processing and transmission of the Services, including your Data, (i) may be transferred unencrypted and involve transmissions over various networks; and (ii) may be changed to conform and adapt to technical requirements of connecting networks or Devices;
   4. we do not guarantee that any file or program available for download and/or execution from or via the Services is free from viruses or other conditions which could damage or interfere with Data, hardware or software with which it might be used;
   5. we are not responsible for the integrity or existence of any Data on the Computing Environment, network or any Device controlled by you or your Authorised Users; and
   6. we may pursue any available equitable or other remedy against you if you breach any provision of these Terms.
5. This clause will survive termination or expiry of these Terms.

15. Termination

1. You may terminate your Licence and/or your access to the Services at any time via your Interrand product
2. It is your responsibility to retrieve all necessary Data from our Software prior to termination.
3. To the extent permitted by law, you may terminate these Terms, if we:
   1. have breached a material term of these Terms and we have failed to remedy such breach within 20 Business Days of receiving notice to do so, subject to any other express right of termination; or
   2. cease operation without a successor.
4. To the extent permitted by law, we may suspend your access to the SaaS Services and/or terminate these Terms immediately by notice if:
   1. you no longer have a valid support entitlement and support entitlement number, as defined in the applicable Interrand Terms;
   2. you breach these Terms and such breach is incapable of remedy, or you fail to remedy such breach within 5 Business Days of us giving you written notice to do so;
   3. you store an excessive amount of Data, as determined by us, or create an excessive load on any of our servers and you fail to remove such data promptly upon our request;
   4. you do not make payment by the applicable payment due date;
   5. we suspect that that you are attempting to reverse engineer the Software;
   6. we consider that a request for Services is unlawful; or
   7. as result of an event outside our control, we are unable to supply the Services in accordance with these Terms.
5. On termination of these Terms:
   1. you must cease using the Services and we will cease to provide the Services;
   2. you agree that any payments made are not refundable to you; and
   3. you agree to promptly return (where possible) or delete or destroy (where not possible to return), our Confidential Information and Intellectual Property, and/or documents containing or relating to our Confidential Information and Intellectual Property.
6. On termination of these Terms, we may retain your documents (including copies) as required by law or regulatory requirements. Your acceptance of these Terms constitutes your authority for us to retain or destroy documents in accordance with applicable statutory periods, or on termination of these Terms.
7. The accrued rights, obligations and remedies of the Parties are not affected by the termination of these Terms.
8. This clause will survive termination or expiry of these Terms.

17. General

1. Our Services will be provided to you on a non-exclusive basis.
2. We reserve the right at any time and from time to time to change or remove features of the SaaS Services provided that, where there is any material alteration to the SaaS Services in accordance with this clause, we will provide you with 20 Business Days’ notice.
3. Subcontracting: We may engage subcontractors to perform the Services on our behalf.
4. Publicity: For the avoidance of doubt, you grant us a non-exclusive, worldwide, royalty-free, irrevocable license to use any of your Intellectual Property in any format for any promotion, publicity, marketing or advertising purposes (Promotional Licence). We may advertise, or publicly announce, that we have undertaken work for you, including in website testimonials and in our marketing material. You grant us the right to use your company name, logo and/or likeness that you provide during registration for this purpose. You may revoke this right at any time by submitting a written request via email to info@ranomize.net.
5. Force Majeure: We will not be liable for any delay or failure to perform our obligations under these Terms if such delay is due to any Force Majeure Event. We will provide you with prompt notice of the occurrence of any Force Majeure Event. If we are delayed from performing our obligations due to such a circumstance for a period of at least two months, we may terminate our agreement with you by giving you five Business Days’ notice in writing.
6. Disputes: Neither Party may commence court proceedings relating to any dispute arising from, or in connection with, these Terms without first meeting with a senior representative of the other Party to seek (in good faith) to resolve that dispute (unless that Party is seeking urgent interlocutory relief or the dispute relates to compliance with this provision).
7. Notices: Any notice given under these Terms must be in writing and addressed to us at the details set out below or to you at the details provided when signing up to the Services. Any notice may be sent by standard post or email, and will be deemed to have been served on the expiry of 48 hours in the case of post, or at the time of transmission in the case of email.
8. Delay:If the provision of the Services depends upon or includes the provision of information, materials, consents or approvals by you or your Personnel, or requires your cooperation, action or response (or that of your Personnel), you will provide that information, cooperation and those materials, consents or approvals in a timely manner. If you breach this obligation, we will be entitled to an extension of time in respect to any deadline or milestone to the extent of the delay caused by you and we will have no Liability for a failure to perform the Services caused by you.
9. Waiver: Any failure or delay by a Party in exercising a power or right (either wholly or partly) in relation to these Terms does not operate as a waiver or prevent a Party from exercising that power or right or any other power or right. A waiver must be in writing.
10. Relationship of Parties: These Terms are not intended to create a partnership, joint venture or agency relationship between the Parties. Nothing in these Terms gives a Party authority to bind the other Party in any way.
11. Severance: If a provision of these Terms is held to be void, invalid, illegal or unenforceable, that provision is to be read down as narrowly as necessary to allow it to be valid or enforceable, failing which, that provision (or that part of that provision) will be severed from these Terms without affecting the validity or enforceability of the remainder of that provision or the other provisions.
12. Assignment: You may not assign, transfer or otherwise deal with all or any of your rights or obligations under these Terms without our prior written consent. Any purported dealing in breach of this clause is of no force or effect. – I don’t understand what the last sentence here means.
13. Entire Agreement:These Terms represent the entire agreement of the Parties in relation to its subject matter and replace and supersede all previous agreements of the Parties, whether oral, written or otherwise, in relation to its subject matter.
14. Amendment: We may at our discretion vary these Terms by notifying you by, for example, publishing varied terms on the Site, sending an email to the billing or technical contact you designate in the applicable Order. If we revise these Terms during the term of your licence or subscription, the revised version will be effective upon your next renewal of the subscription term. In this case, if you object to any revisions, as your exclusive remedy, you may choose not to renew, including cancelling any terms set to auto-renew.
15. Governing law: These Terms are governed by the laws of Canada. You irrevocably and unconditionally submit to the exclusive jurisdiction of the courts operating in Canada and any courts entitled to hear appeals from those courts and waive any rights to object to proceedings being brought in those courts. The Services may be accessed in Canada and overseas. We make no representation that the Services comply with the laws (including Intellectual Property laws) of any country outside of Canada. If you access the Services from outside Canada, you do so at your own risk and are responsible for complying with the laws in the place you access the Services.
16. This clause will survive termination or expiry of these Terms.

For any questions or notice, please contact us at:

Interrand Inc. 533 Highland Ave Ottawa, ON K2A 2J8

Email: info@randomize.net

Last update: 22 February 2020