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inCytes™ License Agreement (Copy for Review)

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December 1, 2021


PLEASE READ THIS AGREEMENT CAREFULLY. IT DESCRIBES RIGHTS TO WHICH YOU MAY BE ENTITLED AND OBLIGATIONS WHICH YOU ACCEPT.

BY USING INCYTES™ YOU AGREE TO BE BOUND BY ITS TERMS. IF YOU DO NOT WISH TO BE BOUND BY THIS AGREEMENT, YOU SHOULD NOT USE INCYTES™.

ABSENT A BREACH BY LICENSOR OF ITS OBLIGATIONS HEREIN, YOUR SOLE REMEDY FOR DISSATISFACTION WITH INCYTES™ IS TO STOP USING INCYTES™.

 

TABLE OF CONTENTS

  1. Definitions
  2. License Terms
    1. Grant of License
    2. Limitations of License
    3. Modification of inCytes™ Functionality
    4. Termination of License
  3. Licensor Obligations
    1. Personal Data
    2. Notifications
  4. Licensee Obligations
    1. Personal Data
    2. Prohibited Activities on inCytes™
    3. Team Members
  5. Specified Personal Data
    1. General
  6. Disclaimers and Limitation of Liability
    1. Disclaimers
    2. Limitation of Liability
    3. Indemnification
  7. Data Ownership
    1. Personal Data
    2. Aggregated Data
  8. Miscellaneous
    1. Entire Agreement
    2. Disputes
    3. Notices
    4. Amendment of License Agreement
    5. Other

1. Definitions

Account

The account specific to Licensee, including the roles, permissions, Team Members, payment mechanisms, Sponsor, Case allocations, Circle memberships and other attributes associated with such account.

Affiliates

Licensor, its owners, subsidiaries, affiliated companies, officers, directors, suppliers, partners, sponsors, and advertisers, and includes (without limitation) all parties involved in creating, producing, and/or delivering inCytes™ and/or its contents.

Aggregated Data

Datasets generated on or through inCytes™ which do not include or reflect Personal Data.

Case

The integrated longitudinal record comprising all data entered against an Observational Protocol for a Patient.

Circle

The combination of (i) one or more Licensees, (ii) a single Observational Protocol applied to one or more Cases, (iii) any Specified Personal Data applicable to such Circle, and (iv) the Aggregated Data collected in the context of that Observational Protocol.

inCytes™

All aspects of the entire inCytes™ platform, including Observational Protocols, Patient Reports, Clinical Reports, Benchmarc™ and other patient portals, the inCytes™ Websites, Circles, Aggregated Data and various related services made available to Licensee through or in connection with inCytes™.

inCytes™ Intellectual Property

Licensor’s worldwide copyright to inCytes™ and all associated content, functionality, materials, patents applied for and/or issued in connection with inCytes™; and all trade secrets and other proprietary elements of inCytes™.

inCytes™ Privacy Policy

The document found here.

inCytes™ Websites

rgnmed.com/technology, incytesapp.co, patient.incytesapp.co, admin.incytesapp.co, incytesapp.com, and such other websites which Licensor shall establish from time to time in connection with inCytes™.

License

A limited, non-exclusive and revocable license to use inCytes™ in accordance with the terms specified herein.

Licensee

Any Person establishing an inCytes™ Account, for whom such an Account has been established, and/or otherwise using inCytes™.

License Agreement

This document, as amended from time to time and published on incytesapp.co.

License Fee

Those fees and other charges payable by Licensee for its use of inCytes™ from time to time, as reflected on Licensee’s Account or otherwise accepted in writing by Licensee.

Licensor

Regenerative Medicine LLC and Regen Med Europe SLU.

Log-In Credentials

An e-mail address, password and if applicable, verification code and other forms of identification specific to each Licensee.

Observational Protocol

The integrated set of Surveys designed by or on behalf of Licensee for the collection of Aggregated Data in the context of one or more Cases.

Person

An individual, organization, society, legal or other form of entity.

Personal Data

Any information or data, which separately or in aggregate, can identify an individual or other information associated with an individual which is entitled to protection or privacy pursuant to applicable Privacy Laws.

Privacy Laws

The laws, regulations or institutional policies which may govern the protection of Personal Data entered onto, or retrievable from, inCytes™.

Specified Personal Data

Any Personal Data which a Licensee chooses to provide to Licensor and requests that the Licensor make available on inCytes™.

Sponsor

The Person responsible for payment under Licensee’s Account. The Sponsor may be the Licensee itself, or a third party. The rights and obligations of a Sponsor may be specified in a separate Sponsorship Agreement.

Team Member

One or more Persons associated with the Licensee, and which the Licensee identifies on its Account as allowed to utilize inCytes™ in the context of Licensee’s Cases, and to view Personal Data of the Patients associated with such Cases.

Other Terms

Terms not defined herein shall have the definitions ascribed to them on the inCytes™ Websites and the Sponsorship Agreement.

2. License Terms

2.1. Grant of License

2.1.1. So long as Licensee is in compliance with the License Agreement, including timely payment of the License Fee and Circle Charges as defined in any applicable Sponsorship Agreement, Licensor grants to Licensee a non-exclusive, non-assignable and revocable right to use inCytes™.

2.2. Limitations of License

2.2.1. Licensor is and shall remain the exclusive owner of all inCytes™ Intellectual Property.

2.3. Modification of inCytes™ Functionality

2.3.1. Licensor reserves the right to modify inCytes™ at any time in a manner which in Licensor’s reasonable opinion improves its functionality and/or user experience.

2.3.2. Licensee may not assign its rights and obligations under this License Agreement to any party, and any purported attempt to do so will be null and void.

2.3.3. Licensee may not sell, resell, reproduce, duplicate, copy or use for any commercial purposes any portion of inCytes™, or allow any party which has not agreed to this License Agreement to use or access inCytes™.

2.3.4. In addition to any excuse provided by applicable law, Licensor shall be excused from liability for non-delivery or delay in delivery of products and services available through inCytes™ arising from any event beyond its reasonable control, whether or not foreseeable by either party, including but not limited to, labor disturbance, war, fire, accident, adverse weather, inability to secure transportation, governmental act or regulation, and other causes or events beyond its reasonable control not enumerated above.

2.4. Termination of License

2.4.1. Licensor may, in its sole discretion, terminate this License with or without notice for any material breach of this License Agreement by Licensee.

2.4.2. Upon termination of the License, Licensee’s right to use inCytes™ immediately ceases, and Licensee acknowledges and agrees that Licensor may immediately deactivate or delete the Account of Licensee and all of Licensee’s Team Members, together with all related information and files in such Accounts.

2.4.3. Licensor shall not be liable to Licensee or any third party for any claims or damages arising out of any termination, or any other actions taken by Licensor in connection with such termination.

3. Licensor Obligations

3.1. Personal Data

3.1.1. Except in the case of Specified Personal Data:

3.1.1.1. Licensor will not have access to and will not seek any Personal Data.

3.1.1.2. In the event Licensor under any circumstances comes into possession of Personal Data entered onto inCytes™, Licensor shall immediately delete it without the requirement to provide any notification to Licensee.

3.1.1.3. Licensor will comply with all applicable Privacy Laws in connection with Personal Data. Details on the implementation by Licensor of applicable Privacy Laws with respect to Personal Data entered onto inCytes™ can be found in the inCytes™ Privacy Policy.

3.1.2. Licensor will never ask Licensee for Licensee’s Log-In Credentials or, in the event such password comes into its possession, disclose it to any third party. Licensor reserves the right immediately and without notice to terminate Licensee’s Account if it appears to be accessed by a Person other than Licensee.

3.1.3. Licensor shall use Specified Personal Data only to the extent and for the purposes indicated by Licensee.

3.1.4. Upon the request any time of a Licensee, Licensor shall delete all or any portion of that Licensee’s Personal Data to which such Licensee has rights. The Licensee agrees and acknowledges that such deletion may negatively affect inCytes™ functionality for such Licensee, and that Licensor shall have no responsibility or liability to Licensee or any third party for costs or damages resulting from such deletion.

3.2. Notifications

3.2.1. Licensor shall notify Licensee of any material changes to this License Agreement.

3.2.2. Any new features that augment or enhance the then-current functionality and/or services on inCytes™ shall also be subject to this License Agreement.

4. Licensee Obligations

4.1. Personal Data

4.1.1. Licensee shall observe all applicable Privacy Laws with respect to Personal Data it enters onto inCytes™.

4.1.2. Under no circumstances shall Licensee disclose any Personal Data to Licensor, except Specified Personal Data which Licensee wishes Licensor to utilize in the context of inCytes™ functionality.

4.1.3. With the exception of an authorized Team Member, Licensee shall not disclose its Log-In Credentials to any other person or entity, or otherwise allow any other person or entity to access inCytes™ utilizing Licensee’s Log-In Credentials.

4.1.4. Licensor shall not be responsible for the use of any Personal Data of a Licensee by another Licensee, or by third parties outside the control of Licensor.

4.1.5. Licensee is solely responsible for maintaining the confidentiality of its Log-In Credentials, and for all statements made and acts or omissions that occur through the use of such Log-In Credentials.

4.2. Prohibited Activities on inCytes™

4.2.1. Except as expressly provided herein, Licensee may not copy, reproduce, modify, republish, upload, post, transmit, or distribute any documents or information from inCytes™ in any form or by any means.

4.2.2. Licensee will not utilize inCytes™ in any manner or for any activities which:

4.2.2.1. are unlawful, threatening, abusive, harassing, defamatory, libelous, deceptive, fraudulent or tortious;

4.2.2.2. Infringe on any patent, trademark, trade secret, copyright, right of publicity, or other proprietary right of any party;

4.2.2.3. constitute unauthorized or unsolicited advertising, junk or bulk email (also known as “spamming”), chain letters, any other form of unauthorized solicitation, or any form of lottery or gambling;

4.2.2.4. contain software viruses or any other computer code, files, or programs that are designed or intended to disrupt, damage, or limit the functioning of any software, hardware, or telecommunications equipment or to damage or obtain unauthorized access to any data or other information of any third party;

4.2.2.5. impersonates the Licensor, or any other Person not legally associated with Licensee; or

4.2.2.6. represent an attempt to copy, decompile, reverse engineer, sell, rent, sub-license or otherwise utilize or appropriate any portion of inCytes™ or its proprietary functionality except in accordance with the terms of this License Agreement.

4.3. Team Members

4.3.1. Licensee shall be responsible for the compliance with the License Agreement by its Team Members.

5. Specified Personal Data

5.1. General

5.1.1. A Licensee may request Licensor from time to time to include Specified Personal Data as part of Licensee’s Account, or otherwise in connection with Licensee’s use of inCytes™. Licensor may in its sole discretion accept or reject such Customization Information.

5.1.2. Licensee warrants and represents to Licensor with respect to such Specified Personal Data that:

5.1.2.1. Licensee owns or has legal rights to use it, and that it grants Licensor a royalty-free, non-exclusive license to use it in connection with Licensee’s Account and use of inCytes™;

5.1.2.2. it is accurate to the best of Licensee’s knowledge and professional judgment; and

5.1.2.3. Licensee will indemnify and hold Licensor harmless from any and all claims, including legal costs, arising from the incorrectness of either of the foregoing two subparagraphs.

6. Disclaimers and Limitation of Liability

6.1. Disclaimers

6.1.1. inCytes™ is provided on an “as is” and “as available” basis, without warranty of any kind, express or implied, including but not limited to the implied warranties of merchantability or fitness for a particular purpose.

6.1.2. Licensor makes no warranty that (i) inCytes™ will meet Licensee’s requirements, (ii) inCytes™ will be uninterrupted, timely, secure or error free, (iii) results obtained from inCytes will be effective, accurate or reliable, or (iv) products or services obtained by Licensee through inCytes™ will meet Licensee’s expectations or be free from mistakes, errors, or defects.

6.1.3. inCytes™ may include technical or other mistakes, inaccuracies or typographical or translation errors. Licensor may make changes to inCytes™ content or services at any time without notice. Portions of inCytes™ may be out of date, and Licensor makes no commitment to update them.

6.1.4. Licensee uses inCytes™ at its own discretion and risk, and Licensee will be solely responsible for any damage or loss of data which results from such use.

6.1.5. Licensor is not responsible for the accuracy or reliability of any opinion, advice, or statement made on or through inCytes™. Licensee should exercise its professional judgment at all times in assessing any such opinion, advice or statement.

6.1.6. Temporary interruptions of the services available through inCytes™ may occur as normal events. Licensor has no control over third party networks Licensee may access in the course of the use of inCytes™, and therefore, delays and disruption of other network transmissions are completely beyond Licensor’s control.

6.2. Limitation of Liability

6.2.1. Licensor shall not be liable to Licensee or any third party for:

6.2.1.1. special, punitive, incidental, indirect or consequential damages, or

6.2.1.2. those resulting from loss of use, data or profits, on any theory of liability arising in connection with Licensee’s use of inCytes™, including any content, service or product provided or accessed through inCytes™.

6.3. Indemnification

6.3.1. Subject to the provisions of Section 6.2.1., Licensor agrees to defend, indemnify, and hold Licensee harmless from all liabilities, claims, and expenses, including attorney’s fees, that arise from Licensor’s material breach of this License Agreement. Licensor has the right to assume the exclusive defense and control of any matter subject to indemnification of Licensee, in which event Licensee will cooperate with Licensor in asserting any available defenses.

6.3.2. Licensee agrees to defend, indemnify, and hold Licensor harmless from all liabilities, claims, and expenses, including attorney’s fees, that arise from Licensee’s material breach of this License Agreement. Licensee has the right to assume the exclusive defense and control of any matter subject to indemnification of Licensor, in which event Licensor will cooperate with Licensee in asserting any available defenses.

7. Data Ownership

7.1. Personal Data

7.1.1. Ownership of Licensee’s Personal Data is specified by law applicable to such Personal Data, provided that under no circumstances shall Licensor have any right or access to, or ownership of, any such Personal Data.

7.2. Aggregated Data

7.2.1. Licensor and Licensee shall co-own all Aggregated Data equally in the absence of specific writing between the Parties to the contrary.

8. Miscellaneous

8.1. Entire Agreement

8.1.1. This License Agreement constitutes the entire agreement between Licensor and Licensee, and supersedes all prior agreements, written or oral, with respect to the subject matter of this License Agreement.

8.1.2. The License Agreement may not be amended without the written consent of the Licensor.

8.2. Disputes

8.2.1. Any disputes relating to matters covered by this License Agreement shall be resolved through binding arbitration pursuant to the rules of the International Centre for Dispute Resolution.

8.2.2. This License Agreement shall be governed by the laws of the State of Delaware, United States of America.

8.3. Notices

8.3.1. All notices to Licensor shall be made to inCytes@rgnmed.com. Notices by Licensor to Licensee shall be made to one or more of the e-mail addresses utilized by Licensee in connection with its Account. Notices relating to GDPR or HIPAA issues shall be made to Licensor’s Data Protection Officer, Nicolas R. Tierney, ntierney@rgnmed.com

8.4. Amendment of License Agreement

8.4.1. Licensor reserves the right to change the License Agreement from time to time by posting such revised License Agreement on the inCytes™ Website. It is Licensee’s responsibility to review the current License Agreement from time to time. Licensee’s continued use of inCytes™ after such modifications will constitute acknowledgement of the modified License Agreement and agreement to abide and be bound by the modified License Agreement.

8.5. Other

8.5.1. Any failure by Licensor to enforce or exercise any provision of this License Agreement or related rights shall not constitute a waiver of that right or provision.

8.5.2. All custom graphics, icons, logos and service names are registered trademarks, trademarks or service marks of Licensor. All other trademarks or service marks are property of their respective owners. Nothing in these License Agreement grants Licensee any right to use any trademark, service mark, logo, and/or the name of Licensor.

8.5.3. If any part of this License Agreement is held invalid or unenforceable, that portion shall be construed in a manner consistent with applicable law to reflect, as nearly as possible, the original intentions of the parties, and the remaining portions shall remain in full force and effect.

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