Terms of Use

RealTime Clinical Trials Managment System and “thevaluetrial.com” Web Application

1. Terms and Conditions
   1. These terms and conditions (“Terms and Conditions”) govern the Service (as defined below) provided by Alira Health SAS., whose registered office is in 55 rue la Boétie – 75008 Paris (France), (“Alira Health”).
   1. Alira Health provides the Service through: (i) the RealTime Patient Clinical Trials Managment System(“Dashboard” or, for purposes of these Conditions of Use, “Patient Portal”) accessible by Professional Users (as defined below); and (ii) the web application, thevaluetrial.com (“App” and, together with the Dashboard, “VALUE Trial Platform”). By using the Dashboard, the Professional User accepts these Terms and Conditions.
   1. Alira Health reserves the right to change and update these Terms and Conditions at its sole discretion. The Professional User will be notified of any changes, which will become effective on the date of the related notification.
   1. The Professional User’s use of the Dashboard after having been notified of changes constitutes his/her full acceptance of the changes made to these Terms and Conditions.

• Definitions
  • “App”: has the meaning given in clause 1.2.
  • “Clinical Site”: means the investigative site, hospital or facility where a Clinical Trial is run and which determines which patients to enroll in a Clinical Trial, the investigator, the sub-investigators, healthcare professionals and associated personnel.
  • “Clinical Trial”: means a clinical trial run by the Customer on behalf of the Sponsor, in relation to which the Services are provided by Alira Health, to investigate the safety or effectiveness of a drug.
  • “Credentials”: has the meaning given in clause 7.2.
  • “CRO”: stands for Contract Research Organization, which means a person, or an organization engaged by the Sponsor to perform one or more tasks and functions related to a Clinical Trial.
  • “Customer”: means an entity, individual or business, purchasing Alira Health Services, pursuant to a contract or an order.
  • “Dashboard”: has the meaning given in clause 1.2.
  • “Data Protection Laws”: has the meaning given in clause10.1.

• “eClinRO”: refers to the validated electronic instruments used to collect the clinician reported outcomes (ClinROs), i.e., the reports provided directly by Investigators about their patients’ health. ClinROs are a type of clinical outcome assessment (COA).
  • “Investigator”: means the person responsible for working within a Clinical Trial at a Clinical Site.
  • “Module”: has the meaning given in clause 6.2.
  • “MediWoundApp”: has the meaning given in clause 1.2.
  • “ VALUE Trial Platform”: has the meaning given in clause 1.2.
  • “Alira Health”: has the meaning given in clause 1.1.
  • “Patient”: means a patient enrolled in a Clinical Trial and authorized by the Professional Users who is enabled to use the App upon acceptance of these Terms and Conditions.
  • “Personal Data”: means any information, including health records, clinical records and patient reported outcomes (PROs), related to an identified or identifiable natural person, as defined under applicable personal data protection and privacy laws.
  • “Professional User”: means the authorized professional user, including the Sponsor, the CRO and the Investigator which will access and manage the data inserted in the App providing activities related to the Service.
  • “Privacy Code”: has the meaning given in clause 10.1.
  • “Privacy Notice”: means the document that informs Patients and Professional Users of the Service, as the case may be, on the management and processing of their Personal Data, as further specified in clause 10.
  • “Questionnaire”: has the meaning given in clause 6.2.1.
  • “Reasons of Force Majeure”: has the meaning given in clause 18.
  • “Service”: means the service provided by the VALUE Trial Platform to record, document and facilitate patient recruitment activities for a given Clinical Trial.  Data quality in relation to a Clinical Trial covers authenticity and completeness.
  • “Service Owner”: means Alira Health.
  • “Sponsor”: means the individual, company, institution or organization responsible for the inception, management and/or financing of a Clinical Trial and that benefits from the Service under a separate agreement.
  • “Trial Site”:  a physical location, such as a hospital, research center, or medical facility, where the clinical trial activities are conducted.

• Purpose of the VALUE Trial Platform
  • The App is available online   and it allows Patients to submit clinical and contact data to assess their eligibility for Clinical Trials. The collected and shared clinical data allows Professional Users to understand the state of health of Patients involved in Clinical Trial screening processes and if necessary direct them to Trial Site locations.
  • The Dashboard is available to Professional Users. It represents individual Patient and aggregated data to ease access and readability of Patient Recruitment data. For enabled product versions, the Dashboard is also intended to collect electronic clinician-reported outcomes (eClinROs) from Investigators.
  • The data provided by Patients and Investigators and collected by the Value Trial Platform is made available to the CRO separately, not in the VALUE trial Platform. The data is therefore processed by the CRO and provided to Professional Users, whose level of access to the data differs depending on their role in a given Clinical Trial.
  • The VALUE Trial Platform is autonomous software that collects and analyses COAs and focuses on each Patient’s involvement in a Clinical Trial.
  • The VALUE Trial Platform is, and must be exclusively used as, a tool for sharing clinical data. For this reason, Alira Health can in no way be held liable for dealings between Professional Users and Patients.
  • The VALUE trial Platform is not a diagnostic tool or an automatic treatment tool for any pathology.  The App is provided to patients to collect information and clinical data relating to the state of their health whilst they participate in a Clinical Trial.
  • The VALUE trial Platform is not a substitute for consultation with, or diagnosis or treatment by, a qualified medical professional, whom Patients should contact if they have doubts regarding their state of health.

• Ownership of the Dashboard
  • Alira Health exclusively owns the Dashboard or has obtained the necessary authorizations to use it, specifically: (i) the source code/s, (ii) the algorithm, (iii) the graphical interfaces, (iv) the content, and (v) the words and figurative trademarks used on the Dashboard.
  • The Professional User is not authorized to use, copy, reproduce, distribute, translate, adapt, modify, publish, distribute to the public or otherwise exploit the Dashboard’s features, instruments or content, or create works deriving from them, in any form or by any means, in whole or in part, unless otherwise expressly permitted by these Terms and Conditions.

• Conditions for using the Dashboard
  • Use of the Dashboard is permitted only to Professional Users who are natural persons who have accessed the App, read the Privacy Notice, consented to personal data processing if required, and accepted these Terms and Conditions.
  • More specifically,  the Dashboard can be used by Professional Users who: (i) are instructed by their organization to use the Dashboard to enable the collection of their ClinROs (applicable to Investigators only); (ii) are involved in a prospective Clinical Trial; and/or (iii) take part in a cohort or registry-based Clinical Trial, including as part of pharmacovigilance activities.

• Content of the Dashboard
  • Professional Users have direct access from their own devices to the Modules, as defined below, available through the Dashboard.
  •  A given Professional Users’ access to a given module is customizable based on said user’s roles and privileges, defined by Alira Health. In cases where Personal Data is restricted due to a Professional User’s role, patient names, dates of birth, medical history, and other protected health information will not be accessible. Users will only see the patient’s record number, current patient status, and any comments associated with the patient. Professional Users can access the following modules through the Dashboard (“Module(s)”), among others:

Module Name	Purpose and Functionalities
“Studies”	Within the “Studies” tab, users can view the recruitment cohort with an overview of all current patient statuses, enrolled roster, call center tab, and a general study info tab.
“Subjects”	Through the “Subjects” tab, users can view all patients referred to the study, demographic information, and medical history information. Users can also make comments, send direct text messages, update the patient statuses, and schedule appointments. Each site and study roster will list all current patients, their current statuses, and any reasons for disqualification.
“My Tasks”	In the “My Taks” tab, Professional Users can access a list of New Not Contacted Referrals, to facilitate appointment scheduling and other patient recruitment activities. Using this module, Investigators can complete questionnaires (eClinROs) to assess the suitability of patients for a given Clinical Trial.
“My Calendar”	From the “My Calendar” tab, Professional Users are able to create, edit and delete events scheduling screening appointments and interviews
“Real Time University”	The “Real Time University” tab contains a range of training videos informing Professional Users of the best practices when using the Dashboard.

• Registration
  •  Every Patient registered in the Dashboard is automatically assigned a Medical Record Number (MRN) as their unique identifier within the application that is valid for the duration of patient recruitment activities for a given Clinical Trial.
  •  Alira Health will create accounts on behalf of Professional Users. To use the Dashboard, the Professional User needs to access the relevant email in his/her email inbox, follow the prompts, and create a temporary password to activate their account. Once the account is activated, the Professional User can access the Dashboard using his/her password (“Credentials”).
  • The Professional User must keep the Credentials confidential and not share them with third parties. If the Professional User experiences problems with his/her account or Credentials, he/she must contact Alira Health without delay. The Credentials are personal, relate to the Professional User only and cannot be transferred to third parties.
  • The Professional User alone is responsible for using all suitable means to ensure the Credentials remain confidential.
  • Each Professional User is responsible for all activities performed using his/her account or Credentials and will inform Alira Health of any use that is unauthorized or otherwise contrary to these Terms and Conditions.
  • Alira Health will in no way be held liable for any damage, of any nature, the Professional User suffers as a result of any use of his/her own account or Credentials, whether by the Professional User or third parties, that is unauthorized or otherwise contrary to these Terms and Conditions.

• Use of the Dashboard
  • After registration, which is completed upon the Professional User’s acceptance of these Terms and Conditions and, if required, consent to the processing of his/her personal data, the Professional User will be able to browse the Dashboard and access the Modules and the Dashboard’s user manual.

• Professional User’s rights and obligations
  • By accepting these Terms and Conditions, the Professional User:
    • Agrees, under his/her responsibility, to provide the ClinROs (the methods of processing the data are described in the related Privacy Notice), if the Professional User is an Investigator; and
    • Will use Dashboard only to use the Service as described in these Terms and Conditions.
  • By accepting these Terms and Conditions, the Professional User acknowledges that Alira Health, through the VALUE Trial Platform, will collect, process, also by using third-party software, and use anonymized data for statistical analysis and to verify proper use of the Service.
  • The Professional User’s account may be deleted at any time.

1. Data Protection
   1. The App complies with the applicable data protection legislation. The Personal Data supplied by the Patient, including the PROs, will be processed in accordance with applicable law, including the California Privacy Rights Act (together “Data Protection Laws”).
   1. If required, the Professional User can consent to the processing of his/her personal data for the methods and purposes set out in the Privacy Notice by selecting this option during registration. Personal Data will be used only for the purposes set out in the Privacy Notice and in accordance with the authorizations granted.
   1. Further information regarding Personal Data processing is available in the Privacy Notice provided at the time of the Professional User’s registration and can be viewed in the Support section of the App.

1. Professional User’s responsibility
   1. The Professional User is responsible for the correct use of the Dashboard, for the information he/she will provide and for the management of the information added by the Patient  via the App. Each Professional User represents and warrants that the information provided in the Dashboard is true and correct. Alira Health reserves the unconditional right to delete the account and deny the Professional User access to the Dashboard if the information is found to be inaccurate or false. Professional Users whose access to the Dashboard is blocked cannot create new accounts.
   1. If any disputes are brought against Alira Health by third parties concerning the Professional User’s data, content or alleged misconduct when using the Dashboard, the Professional User will be held personally liable to the third parties and to Alira Health.

1. Service Owner’s rights and obligations
   1. Alira Health, in its capacity as Service Owner, grants the Professional User a worldwide, non-exclusive, non-sub-licensable license of use – non-transferable to third parties – throughout the period of use of the Service, to use the Service via the Dashboard. The Patient will have no claim over Alira Health’s property.
   1. Alira Health, in its capacity as Service Owner, endeavors to keep the data, including Personal Data and all information received, in a suitable place for the appropriate amount of time, based on the intended use. Account data not used by the Professional User in relation to the Service will be stored for the period required by law, in accordance with the Privacy Notice and, if required, the consent given in order to use the Dashboard and allow data processing during the use of the Dashboard.

1. Use of specific technologies
   1. The App may use software developed and owned by third parties.

1. Data supplied by third parties
   1. Alira Health, in its capacity as Service Owner, neither controls nor manages information or data supplied by third parties and, therefore, third parties are solely responsible for the information and data they provide.
   1. Alira Health is in no way responsible for the veracity or accuracy of data and information inserted by the Professional User through the Dashboard.

1. Disclaimer
   1. The dashboard cannot cause damage or injuries to the professional user’s health if used in accordance with these terms and conditions.
   1. The value trial platform is, and must be exclusively used as, a tool for sharing clinical data. For this reason, alira health can in no way be held liable for dealings between professional users and patients.
   1. The dashboard is not a diagnostic tool or an automatic treatment tool for any pathology. Data provided to investigators via the dashboard is not to be used to take decisions with diagnosis or therapeutic purposes.
   1. The dashboard is not a substitute for consultation with, or diagnosis or treatment by, a qualified medical professional, whom the patient should contact if he/she has any doubts regarding his/her state of health.
   1. Alira health provides no guarantees and assumes no liability, within the limits of the law, for any direct or indirect damage (including, without limitation, damage from disruption of service or data loss) to the professional user from the use or impossibility to use the service for reasons not directly attributable to alira health.
   1. Any other liability mandatory by law is limited to the service, thus expressly excluding any liability for direct and/or indirect damage that is the consequence of the professional user’s or third parties’ misconduct, i.e., abusive access or use of data, including personal data.

1. Limitations in providing the Service
   1. Alira Health reserves the right to amend, suspend or cancel, in whole or in part, the Service at any time, including without notice.
   1. Alira Health cannot be held liable for any damage resulting from a failure to provide the Service because of malfunctions or failures in electronic communication devices for reasons not attributable to Alira Health.
   1. Alira Health will notify the Professional User via the Dashboard or by email of any suspensions or cancellations of the Service.

1. Term
   1. These Terms and Conditions apply for the period the Professional User uses the Service.

1. Force majeure
   1. Alira Health is exempt from any liability for the failure or delay in fulfilling its obligations under these Terms and Conditions, or arising from the suspension of – or impossibility to access – the Service offered through the VALUE Trial Platform due to force majeure events out of its reasonable and foreseeable control, including, but not limited to, national strikes, terrorist attacks, civil insurrections, fires, explosions, internet or electronic device (including mobile phone) malfunctions for any reason, blackouts, and calamities of an exceptional nature (“Force Majeure Events”).
   1. Upon occurrence of a Force Majeure Cause, Alira Health will promptly notify the Professional User via the Dashboard or by email, or by contacting his/her respective organization.
   1. Alira Health’s fulfilment of its obligations under these Terms and Conditions will be suspended for the period of any Force Majeure Events.

1. Validity and amendments
   1. These Terms and Conditions apply, where necessary, to other different and specific agreements.
   1. Alira Health may make changes to these Terms and Conditions at any time, at its own discretion and unilaterally, in which case it will notify the Professional User via the Dashboard or by email.
   1. The Professional User’s use of the Service after these changes constitutes his/her express acknowledgment and acceptance of the changes and updates. The Service Owner will request the Professional User’s express acceptance of the changes if required.

• Partial Severability
  • If any clauses of these Terms and Conditions are held to be invalid, illegal or unenforceable by law, competent authorities or court decisions, the remaining clauses will be unaffected.

• Governing law and jurisdiction
  • The relationship between Alira Health and the Professional User is governed by United States law.
  • Any consumer disputes arising out of or in connection with these Terms and Conditions will be subject to the rules of the Federal Trade Commission (FTC) Act (“Consumer Code”).
  • Without prejudice to any applicable laws, any disputes arising out of or in connection with these Terms and Conditions will be subject to the exclusive jurisdiction of the United States District Court for the District of Massachusetts.