PROLABELS : patient-reported outcomes
& drug marketing authorizations
www.mapi-prolabels.org
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 Terms & Conditions Last updated 09 September 2008 This website is owned and operated by Mapi Research Trust (MRT), whose business address is 27 rue de la Villette, 69003 Lyon, France, registered in Carpentras under number 453 979 346 00013. For any information, please contact . Warning: By accessing or using the PROLabels Site, User agrees to be bound by the terms and conditions below ("Terms and Conditions"). MRT reserves the right to change, modify, add or remove portions of these Terms and Conditions in its sole discretion at any time and without prior notice. User must check this page periodically for any modifications at www.prolabels.org. User’s continued use of this Site following the posting of any changes will mean that User has accepted the changes.
1. SCOPE OF SERVICES 1.1. Scope. MRT is a non-profit organization promoting Patient-Reported Outcomes (PRO). MRT developed PROLabels in partnership with Mapi Research Institute and Mapi Values to provide information on the use of PROs in drug marketing approvals and to promote the use of the patient perspective in evaluating treatment outcomes. 1.2 Conduct of Services. As a provider of information, MRT reserves the right to add or withdraw information and modify or otherwise change the Service (including features) as necessary. MRT will exert its best efforts and professional expertise to ensure that the Services will be conducted pursuant to provision 1.1. 1.3 Links to Other Sites. The PROLabels Site may contain hyperlinks to other sites or resources that are provided solely for User’s convenience. MRT is not responsible for the availability of external sites or resources linked to the Site, and does not endorse and is not responsible or liable for any content, advertising, products or other materials on or available from such sites or resources. Because MRT is not responsible for the availability or accuracy of these outside resources or their contents, User should review the terms and conditions and privacy policies of these linked sites, as their policies may differ from MRT’s. 2. PAYMENT 2.1 Free access. A brief description of the database is accessible free of charge. User of this free level is nevertheless bound by all obligations described in these Terms and Conditions. 2.2 Advanced access. Yearly subscriptions to the database are proposed to universities, libraries, hospitals, associations, institutions, non-profit organizations, as well as to pharmaceutical and profit-making companies. 2.3 Invoices and Payments. MRT will send invoices to User setting out in detail the Services provided and the amounts paid. 3. CONFIDENTIALITY 3.1 Confidentiality. User agrees that, site layout, design, images, programs, text and other information as well as passwords given by MRT to enable access to the database are and will be considered to be Confidential Information. 4. USE 4.1 Use. User may not use any data or documentation received from MRT except as expressly provided in these Terms and Conditions. User may not copy, display, distribute, modify, publish, reproduce, store, transmit, create derivative works from, or sell or license all or any part of the Content, products or Services obtained from the Services in any medium to anyone, except as otherwise expressly described in these Terms and Conditions. 4.2 User agrees, for itself and for any party acting by or through User (i) to allow its password(s) and any documentation, or data received from MRT, to be used only by User 's employees which are referred to as the "Authorized Users"; (ii) not to transfer, by any means whatsoever, any data or documentation received from the PROLabels Database (or copies thereof), to any person, organization or institution outside the "Authorized Users" and to prohibit any "Authorized User" from doing so; (iii) not to sell, exchange, barter, or transfer, rent, lease, loan, resell for profit, distribute or in any other manner commercially exploit any data or documentation received from MRT; or obscure copyright notices contained on data or documentation received from MRT. 4.3 In the event of loss or theft of a password, it is User 's responsibility to notify MRT immediately, in writing and User shall be relieved of liability for charges incurred on such password subsequent to MRT's receipt of such notice. MRT reserves the right to change any password at any time as it deems necessary. 5. WARRANTY AND LIABILITY 5.1 User assumes all risks related to the use of any information provided in PROLabels. Data available on all drug products were collected from the regulatory agencies website and MRT provides the data "as is". PROLabels does not report the full labeling information of a given drug product but only results of the PRO label. For a complete labeling information, user is to refer to the regulatory agency that has granted the marketing authorization. 5.2 MRT does not make any warranty whatsoever, including without limitation, that the operation of the Site will be uninterrupted or error-free; that defects will be corrected; that this Site, including the server that makes it available, is free of viruses or other harmful components. 6. INTELLECTUAL PROPERTY RIGHTS 6.1 All trademarks and copies of original documents appearing on the Services are the property of their respective owners as stipulated by the related copyright notices and are protected by copyright and other intellectual property laws. The FDA documents are in the public domain. 6.2 All other content in the Services, including site layout, design, images, programs, text and other information (collectively, the "Content") is the property of MRT and its affiliated companies or licensors and is protected by copyright and other intellectual property laws. 6.3 User may not engage in systematic retrieval of Content from the Service to create or compile, directly or indirectly, a collection, compilation, database or directory without prior written permission from MRT. 6.4 Any ideas, concepts or materials submitted to MRT by User regarding the Service become MRT's property to exploit or to not exploit as MRT solely deems appropriate without necessity for remuneration or attribution to User. 7. TERM AND TERMINATION 7.1 Term and Termination. The term of these Terms and Conditions shall begin on the date of User’s acceptance of said Terms and Conditions. The Service may be terminated by MRT at any time in the exercise of its sole discretion in the event of a breach by User such as use of the Services in a manner which is not permitted by these Terms and Conditions or default of payment of the invoices for access to the advanced level. 8. MISCELLANEOUS 8.1 Independent Contractor. User's status hereunder is that of an independent Contractor and not as an employee or agent of MRT, and User has no authority to bind or act on behalf of MRT. 8.2 Publicity. Neither party shall use the name of the other for any promotional purposes without the prior written consent of the party whose name is to be used, nor shall either party disclose the existence or contents of this Agreement. 8.3 Personal Data Protection Law. Some information about User are registered in an internal Mapi Group database (information about User as a company and information about User’s contact people). This information enables the MAPI Group staff members to contact User in the context of a project or for other business activities. As required by the French personal data protection Law N° 78-17 of 6 January 1978 modified, this database was declared to the French commission (CNIL) and registered by this commission; MAPI Group staff members who use this information are required to apply the law ;User as a company and/or User’s contact people have a right of accession, correction of the data registered about them. They can also object to the processing of these data on legitimate grounds (articles 38, 39 and 40 of the above-mention Law). To this end, please contact Mapi Research Trust, 27 rue de la Villette , 69003 Lyon, France. 8.4 Force Majeure. MRT shall not be liable or deemed to be in default for any delays or failure in performance or interruption of the Services resulting directly or indirectly from any cause or circumstance beyond their reasonable control. 8.5 Survival. Notwithstanding expiration or termination of these Terms and Conditions for any reason, rights and obligations, which by their nature should survive, will remain in full force and effect. In particular (and not by way of limitation), the provisions related to obligations of confidentiality, use, intellectual property rights will survive expiration or termination of these Terms and Conditions. 8.6 Severability. If any of the provisions or a portion of any provision of these Terms and Conditions is held to be unenforceable or invalid by a court of competent jurisdiction, the validity and enforceability of the enforceable portion of any such provision and/or the remaining provisions will not be affected. 8.7 Indemnification. User hereby agrees to indemnify, defend and hold MRT, its directors, officers, shareholders, parents, subsidiaries, affiliates, agents and licensors harmless from and against any and all liability, losses, damages and costs, including, without limitation, reasonable attorneys' fees, arising from User’s use of the Services. 8.8 Governing Law and Venue. These terms and conditions shall be governed by and construed in accordance with the laws of France, without regard to its conflicts of law principles. User hereby submit to and agree that the sole jurisdiction and venue for any actions that may arise under or in relation to the subject matter hereof shall be the courts located in Lyon - France. Mapi Research Trust
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