User Agreement General Terms

September 8, 2014

Mapi Research Trust, a not-for-profit organisation subject to the terms of the French law of 1st July 1901, registered in Carpentras under number 453 979 346, whose business address is 27 rue de la Villette, 69003 Lyon, France, hereafter referred to as “MRT” and the User, as defined herein, (each referred to singularly as a “Party” and/or collectively as the “Parties”), do hereby agree to the following User Agreement Special and General Terms:

 

Recitals

MRT facilitates access to information in the fields of Patient-Reported Outcomes (PRO), Clinician-Reported Outcomes (ClinRo) and epidemiology and encourages exchanges between various users around the world by providing, in particular, the availability, translation (where appropriate) and distribution of Questionnaires.

The User wishes to be able to have access to one or multiple Questionnaires and to use each such Questionnaire in accordance with the terms and conditions set forth in the Agreement.

 

Article 1. Definitions

For the purposes of this Agreement, the Parties agree to the following definitions to the terms listed below, when capitalized:

 

Author

refers to the author(s) of the Questionnaire and of the Documentation that may accompany it.

Beneficiaries

refers to the individuals or legal entities directly involved in the Study, who need access to the Questionnaire as part of their activity.

General Terms

refers to these General terms of the Agreement attached as Appendix 1 to the Special Terms and fully incorporated therein.

Special Terms

refers to the Special terms of the Agreement which incorporate these General Terms to collectively form the Agreement.

Agreement

refers to the user agreement of the Questionnaire which binds MRT to the User, made up of a combination of the General Terms and the Special Terms.

Author Agreement

refers to the separate agreement between the Author and MRT by which the Author transfers the rights to MRT to sublicense  and reproduce the Questionnaire.

Documentation

refers to all documentation provided by MRT to the User for the Questionnaire, including but not limited to, any article, explanatory notice, observations or any other document accompanying the Questionnaire or related to or referencing the Questionnaire and provided by MRT to the User.

Study

refers to all types of clinical trials, research projects or any other project, as defined by the Parties within the Special Terms, for which MRT authorises the use of the Questionnaire by the User.

Confidential Information

refers to all information exchanged between the Parties regarding the Agreement, by oral, verbal, or tangible means or any means of communication whatsoever.

PRO

refers to  Patient-Reported Outcomes which are the results reported by the patients in connection with a Study.

ClinRo

refers to Clinician-Reported Outcomes which are the results reported by the Clinicians in connection with a Study.

Owner

refers to the owner of the author’s economic rights in the Questionnaire and/or in any Documentation, which may include, but is not limited to, the Author of the Questionnaire and/or its publisher.

User

refers to the user of the Questionnaire as defined within the Special Terms and that is a Party to this Agreement.

Questionnaire

refers to the questionnaire  as identified in Section 1.02 and for the territories and languages listed in Article 5 of the Special Terms

 

Article 2. Content of the Agreement

The Agreement constitutes the whole understanding between the Parties regarding its subject matter, and cancels and replaces any prior declaration, negotiation, undertaking, verbal or written communication, acceptance, understanding or arrangement between the Parties regarding the same subject matter.

The Agreement consists of the contractual documents as follows, in their decreasing legal hierarchical order:

-           Special Terms (including Appendix);

-           General Terms.

In the case of contradiction between two documents of the same level, the more recent document shall prevail.

In the event of interpretation difficulties or contradiction between one of the headings used for the clauses and the content of one of the clauses, the headings shall be declared as inexistent and the content of the clauses shall control.

 

Article 3. Purpose

This Agreement sets forth the terms and conditions by which MRT transfers a limited, non-transferable right to the User to use the Questionnaire as part of the Study.

 

Article 4. Rights granted

Section 4.01     Author’s and Owner’s rights

The Questionnaire is proprietary content, information and material that is protected by applicable intellectual property and other laws, including but not limited to copyright, which the User may not use in any way whatsoever except as permitted pursuant to this Agreement.  

The Author owns all rights of copyright to the Questionnaire and any derivative work from the Questionnaire including but not limited to existing and future translations, and in particular the rights to reproduce, perform, amend, adapt and translate the Questionnaire.

The Author also owns all of the moral rights on the Questionnaire, and therefore has, in particular, the right to authorship of the work, the right to preserve the integrity of the Questionnaire, to perform or prevent it from alteration, distortion or destruction and the right of withdrawal.

Where appropriate, the Author may have transferred all or a portion of the rights to the Owner.

Through the Author Agreement, the Author and/or the Owner have transferred a portion of the moral and/or economic intellectual property rights to sublicense and reproduce the Questionnaire to MRT, and have authorised MRT to transfer, on a non-exclusive basis, a portion of these rights to the users interested for specific purposes, and in particular to the User for the purpose of the Study.

 

Section 4.02     Rights of Use

MRT transfers to the User, which accepts the same, the rights to use and reproduce the Questionnaire in accordance with the terms and conditions specified herein, for the period and in the territory as defined in the Special Terms.

 

Section 4.03     Limits

The User undertakes, unless otherwise specifically authorised in writing by MRT, to refrain from using or reproducing the Questionnaire in any way and on any format whatsoever, with the exception of doing so for the purpose of fulfilling a requirement for the Study as set forth in the Specific Terms. 

The Parties hereby agree that any data, result or report obtained or prepared from a lawful use of the Questionnaire shall remain the exclusive property of the User.

 

Section 4.04     Beneficiaries

The Parties agree that the rights to use and reproduce the Questionnaire are hereby transferred to the User pursuant to this Agreement

The Beneficiaries have complete access to the Questionnaire as necessary in strict adherence to their function in the context of performing the Study.

Subject exclusively to MRT’s prior, written and specific consent, the rights of use of the Questionnaire as set forth in this Agreement may be transferred by the User to the Beneficiaries.

The User guarantees that the Beneficiaries will respect the obligations of the Agreement and in particular the undertakings regarding confidentiality, and accepts liability for any breach of this Agreement by the Beneficiaries in relation to MRT.

 

Section 4.05     Translation of the Questionnaire

The terms and conditions that apply to the translation of the Questionnaire are stipulated in the Special Terms. The User undertakes not to translate the Questionnaire nor have it translated by any means whatsoever other than those means stipulated in the Agreement.

 

Article 5. Delivery

The Questionnaire will be delivered to the User at the address of the contact person indicated in the Special Terms promptly following payment of the price owed by the User in accordance with the terms of Article 6 of the General Terms.

 

Article 6. Price and Payment Terms

Section 6.01     Price

The Parties agree that MRT’s remuneration, in return for the availability of the Questionnaire pursuant to the Agreement, is calculated on a lump-sum basis.

 

Section 6.02     Payment Terms

The User may pay the price by bank transfer, cheque or bank card.

The User undertakes to pay the amounts due within a period of thirty (30) days from the date indicated on the invoice.

 

Article 7. Term and termination

Section 7.01     Term

The Agreement is valid for the period stipulated in the Special Terms.

The confidentiality and non-disclosure obligations stipulated in article 9 of the General Terms shall survive expiration or termination of this Agreement for any reason whatsoever and shall continue to apply without limitation.

 

Section 7.02     Termination

(a)     Termination due to financial disruption of the Parties

If for any reason whatsoever, one or both Parties ceases to conduct all business activities, the Agreement shall terminate immediately and without penalty and any compensation being owed by either of the two Parties to the other.

 

(b)     Termination for breach

In the case of lack of performance by the defaulting Party of one or more of its obligations owed pursuant to the Agreement, the other Party has the possibility of terminating the Agreement, ipso jure, if the defaulting Party has not rectified the breach detailed in a registered letter with confirmation of receipt within a period of thirty (30) days as from it being sent.  The non-defaulting Party may terminate without prejudice to any damages that it may be entitled to claim from the defaulting Party, as compensation for the prejudice caused by the defaulting Party, notwithstanding the cause or origin of the damages.

 

(c)     Consequences of the termination

In the event of termination of the Agreement for whatever grounds, the User should remove, return or destroy, as instructed by MRT, all Documentation and other materials, documents, data and information in its possession, whether held electronically or by other means, in relation to the Agreement, within a period of thirty (30) days of such termination. However, the User may keep a single copy of such materials for the purposes of archiving information necessary for tax or regulatory inspection.

 

Article 8. Personal Data

The User acknowledges and accepts that MRT may communicate the following information to the Author and to the Owner:

-           the User’s surname and first name, his/her occupation, his/her personal address, his/her professional activity if the User is an individual;

-           the User’s name, its legal form, the address of its registered office and its activity if the User is a legal entity;

-           the contact name in charge of the Agreement and addressee of the Questionnaire;

-           the date and content of the Agreement.

In accordance with the terms of Articles 39 and thereafter of the French Data Protection Law of 6th January 1978, amended, the User benefits from a right to access, rectify and oppose the information described in this Article 8 above. Any User wishing to use this right may send a written request in this respect to the MRT contact person in charge of the Agreement or to the MRT email address as indicated in the Special Terms.

 

Article 9. Confidentiality

Each Party undertakes specifically:

-           to keep the Confidential Information strictly confidential, and in this respect, to protect it in accordance with the same or more restrictive standards of protection applicable to its own confidential information and documents, and in particular from public disclosure, theft, unauthorized duplication, reproductions or unauthorised use;

-           not to disclose the Confidential Information to any person, firm, company or third party whatsoever, in return for payment or free of charge, in any way whatsoever, with the exception of the persons to whom such disclosure is legally required.

-           to ensure and remain responsible for its sub-contractors or any company taking part in providing the Services, at any time whatsoever and in any way whatsoever, respecting the non-disclosure obligation as stipulated in the Agreement;

-           to immediately stop, upon simple request from the other Party, any use of the Confidential Information, and any reproduction of it without however being relieved from its confidentiality and non-disclosure undertaking.

The Parties agree that MRT is entitled to give a copy of the Agreement to the Author and to the Owner upon simple request from either, and may do so without infringing this confidentiality obligation.

 

Article 10. Liability and guarantee

Section 10.01   Liability

Each Party acknowledges that it is subject to an obligation of results and full and complete execution and compliance with regard to  the performance of its contractual obligations.

Furthermore, each Party is liable for the direct damage resulting from the lack of performance or poor performance of the obligations incumbent upon it in relation to the Agreement. The Parties may not be held liable for any indirect, consequential, punitive or circumstantial damages, such as, but not limited to, the loss of activity or loss of opportunity, which may occur due to the performance of the Agreement.

Finally, MRT may not be held liable for the termination of the Agreement due to the termination of the Author Agreement on the Questionnaire for any reason whatsoever.

 

Section 10.02   Guarantee

MRT acknowledges that, to its knowledge, the Questionnaire does not infringe third party rights and that it has the rights required to enter into this Agreement to sublicense and reproduce the Questionnaire. 

MRT undertakes in particular to protect the User and pay compensation to the User in the event of a claim by a third party against User for any damage caused by a breach or misappropriation by MRT of the copyright existing on the Questionnaire.

 

Article 11. Force Majeure event

If the performance of the Agreement is stopped or delayed further to a force majeure event such as third party strikes, third party lockouts, third party labor troubles, restrictive Regulatory Authority actions, orders or decrees, riots, insurrection, war, Acts of God, severe inclement weather or other similar reason or cause which is unforeseeable or beyond the reasonable control of such Party, the Party affected by the force majeure event must (i) inform the other Party of the same immediately and (ii) take all appropriate measures in order to reduce or remove the impact of the force majeure event, and endeavour to recover the performance of the obligations which have been deferred or prevented by such event.

Neither Party will be held liable for the delays or hindrances in performing its obligations due to a force majeure event, when the delay or hindrance is the result of such force majeure event.

If a force majeure event affects one of the Parties and continues for more than thirty (30) days, the Agreement shall be terminated and ipso jure deemed as null and void.

 

Article 12. Miscellaneous

If one or several terms of the Agreement are deemed as invalid or declared as such in accordance with a law, regulation or further to a final ruling from a relevant court, the Agreement remains applicable and the other terms will maintain their effect and scope.

The fact that one of the Parties does not take advantage of a breach by the other Party, of one of the obligations stipulated in the Agreement, may not be interpreted in the future as a waiver of the obligation in question.

Any invalidation of any of the terms of the Agreement shall not entail the cancellation of the Agreement as a whole. In the case of cancellation, the Parties shall endeavour in any event to hold good faith and honest negotiations with the goal of  drafting a clause that is equivalent in intent and commercial effect.

The User is forbidden from transferring or assigning, in any way whatsoever, the Agreement and the resulting rights and obligations, outside of the context of the Study and without having informed MRT beforehand in writing.

Any changes, modifications, or alterations to the terms and conditions of the Agreement (notably for an extension of the Term of the Agreement and for additional languages versions of the Questionnaire) shall be agreed by written amendment to the Agreement signed by both parties.

User agrees that any requests for additional languages versions of the Questionnaire shall be subject to the prices into effect at the date of such requests.

 

Article 13. Jurisdiction and Applicable Law

This Agreement is subject to French law.

The Parties will endeavour to settle their differences on an out-of-court basis prior to referring their case to the courts.

In the case of disputes regarding the validity, interpretation or performance of the Agreement, exclusive jurisdiction is granted to the court with jurisdiction located in Lyon, notwithstanding several defendants or the introduction of third parties, even for summary proceedings or proceedings on petition.