IRP – INSTITUT DE RECHERCHE PHARMABIOTIQUE
A non-for-profit association governed by the French law of July 1st, 1901 and decree of August 16th, 1901, having its principal place of business at 1 Quai Vallière, 11100 Narbonne, France, represented by Magali CORDAILLAT-SIMMONS
IRP – INSTITUT DE RECHERCHE PHARMABIOTIQUE/PHARMABIOTIC RESEARCH INSTITUTE (hereinafter “PRI”).
The term “User” refers without distinction to PRI Members and non-member but simply users of the Site.
The term “Member” refers to any person who has signed a PRI membership form.
Credit and copyright for photographs on the Website: PRI
ARTICLE 1- INTRODUCTION
1.1- PRI is a European multidisciplinary non-for-profit Association supporting the development and registration of therapeutic and diagnostic products emerging from microbiome science. PRI aims at educating and federating the industry, academic institutions, and EU regulatory representatives.
1.2- PRI is an independent and neutral association. Its neutrality is key for a collaborative approach between actors who may have conflicting interests. In addition, this neutrality is the pre-requisite for a healthy relationship with the competent authorities and the future negotiation relating to regulatory frameworks evolution for new therapeutic and diagnostic modalities emerging from microbiome science.
1.3- PRI is a collaborative association. At the heart of PRI is its collaborative approach which allows it to more credibly pave the way for regulatory evolutions in Europe. The very essence of this collaborative approach is that stakeholders, as well as competent authorities, may learn from each other and together be able to make a real difference.
1.4- PRI will not engage in paid-for consulting services, marketing activities, market analysis services, nor perform lobbying or other political influencing activities. PRI will not act as an observatory of the microbiome and its industry.
1.5- PRI will not actively address the regulatory challenges surrounding the development and commercialization of food or food supplements, or cosmetic products, but merely track and study these developments for comparative and explanatory purposes. PRI will also not actively address the regulatory challenges surrounding the development of other microbiome-based consumer care products and services, in as much as they are not intended to treat, prevent, or cure disease or make a medical diagnosis.
1.6- PRI will not directly address the regulatory challenges surrounding the development and registration of new therapeutic and diagnostic products emerging from microbiome science outside of the European Union. While PRI realizes it is important to monitor and understand foreign regulatory frameworks, they will not actively engage with non-EU authorities but build strategic partnerships and collaboration with other relevant industry or academic organizations.
1.7- PRI shall not engage in price-fixing, anticompetitive agreements, or any other unfair methods of competition that restrain trade and are prohibited.
1.8- Any reference to PRI whatsoever, express or implied, by a Member on its website or in any other medium shall not be construed as a guarantee of quality, reputation, ethical responsibility or any endorsement of any sort, of such Member by PRI.
1.9- Any mention of PRI Membership by a Member on its website or in any other medium shall not be construed as a guarantee of quality, reputation, a ethical responsibility or any endorsement of such Member by PRI.
ARTICLE 2 – WEBSITE PURPOSE
2.1- This Website is intended to provide Users with general information on PRI, its activity, organization, research, communication, membership process, as well as news and events.
2.2- The information on this Website shall not be construed as official information arising out of regulatory authorities.
2.3- The information on this Website shall not be construed as promotion or advertising of products, whether or not marketed by its Members.
ARTICLE 3 – USE OF THE WEBSITE
3.1- PRI strives to ensure the accuracy and updating of the information presented on the Website.
3.2- Notwithstanding the above, the Information on the Website is provided to Users “as is” without any warranty of any kind, tacit or express. PRI in no way guarantees the truthfulness, completeness, accuracy or exhaustiveness of the information and content made available to Users on the Site and reserves the right to modify or correct, at any time and without notice, the content of the information and documents published on the Website.
3.3- Except as otherwise provided for in the present Legal Notices, and provided that Users comply with all their obligations under the present Legal Notice, Users may view, copy or print (but not modify) the content of this Website, provided that (i) such use is for informational and non-commercial purposes only and (ii) any copy includes the copyright notice or any other rights PRI holds on the Website.
ARTICLE 4 – MODIFICATION OF THE WEBSITE
4.1- PRI reserves the right to modify the Website and its content, as well as the present Legal Notices in order to comply with applicable French and EU legislation and regulations and/or in order to improve the use and performance of the Website.
4.2- PRI recommends that Users keep themselves regularly informed of the Legal Notices of the Website.
ARTICLE 5 – ACCESS TO THE WEBSITE
5.1- PRI strives to make its best efforts to keep the Website accessible to Users. However, PRI cannot guarantee its permanent availability and accessibility.
5.2- Based on the foregoing, PRI reserves the right to temporarily restrict, suspend and/or terminate the functionalities of the Website and/or access to it, partially or totally, for any reason whatsoever and in particular technical reasons such as maintenance, in the event of computer problems, difficulties related to the structure of communication networks, the occurrence of a force majeure event or any other technical difficulty.
ARTICLE 6 – LIABILITY
6.1- This Website is provided “as is” and PRI makes no warranties or representations, express or implied, regarding its content.
6.2- PRI does not warrant the security or freedom from error, viruses or malware of this Site or its compliance with any defined performance or quality criteria.
6.3- The Users use this Website is at their own risks and will assume all consequences of such use, including but not limited to loss of data. PRI will not be held liable for any direct, indirect, special, incidental, punitive or other damages of any kind arising out of any action by the User, tort or otherwise, related to or resulting from the User’s use of this Website.
6.4- Certain links on this Website may direct the Users to other websites, resources or tools provided by third parties over whom PRI has no control. Notwithstanding the foregoing, PRI makes no representations or warranties, express or implied, with respect to such third-parties websites, resources or tools and links to such websites, resources or tools shall not be construed as an endorsement of such websites or their content.
6.5- The aforementioned exemptions and limitations of liability are applicable to the extent provided for by contractual, legal or tort law or of any other nature.
6.6- PRI cannot be held liable for direct or indirect damage resulting from the misuse, inappropriate or non-compliant use of the Site and/or its content by the User of the Website.
ARTICLE 7 – INTELLECTUAL PROPERTY
7.1- All content available on the Website, including, but not limited to, text, graphics, pictograms, images, photographs, drawings, sounds, audio and video data, as well as the tree structure of the Website, its navigation plan, its logos, the design and organization of its sections, their titles, the database, their structure and their content, the brands (hereinafter referred to as the “Content“) is the exclusive property of PRI and is as such protected by Intellectual Property laws or by provisions relating to image rights.
7.2- Only copying for private use is authorized in accordance with the competent Intellectual Property laws.
7.3- Consequently, any commercial exploitation, representation, distribution, reproduction, adaptation, translation, transformation, total or partial, by any means whatsoever, of the Website and/or its Content, sharing of the Content of the Website as well as any transfer to another website without the prior written authorization of PRI are strictly prohibited. Any request for authorization to reproduce or represent the Website and/or the Content must be sent to PRI at the following address: email@example.com
7.4- In any case, the User undertakes to keep and copy each copyright or property right notice indicated in any element of the Website that he uses in compliance with the present Legal Notices.
7.5- Furthermore, the trademarks and logos appearing on the Website are registered trademarks and may not be used without the express authorization of their owner. As such, reproduction, in whole or in part, of such trademarks and logos appearing on the Website, without the prior written authorization of PRI, constitutes an infringement and/or unfair competition.
ARTICLE 8 – MEMBERSHIP ELIGIBILITY
8.1- To apply to become a Member, the candidate must comply with the process defined in the Internal Policies and Procedures document: Join us | PRI (pharmabiotic.org).
8.2- Every member is bound to abide by the Bylaws, along with the Charter of Ethics, annex to these Bylaws, as well as any other annex to which they become signatory when becoming a Member.
8.3- Payment of the annual membership dues, following signature of the membership contract, confirms the membership of the organization. The table of Membership fees can be found in the Association Internal Policies and Procedures document.
8.4- The Board retains the power to affirm, suspend or dismiss any Member.
ARTICLE 9 – MEMBERSHIP CATEGORIES
9.1- ‘Active Members’ are private-, public- or government-owned corporate entities, that play a part in the development, commercially exploiting or planning to commercially exploit new therapeutic and diagnostic modalities emerging from microbiome science under whatever form (strain, bulk, or finished product), by any method of distribution, towards all sorts of clients (BtoB or BtoC) in any arena worldwide. Any private corporate entities proposing services to the corporate entities described above may as well be an Active Member of the association. Active Members are also private-, public- or government-owned corporate entities that wish to perform and finance R&D initiatives or create consortium projects in which they employ the expertise and know-how of the PRI.
9.2- ‘Active members’ are divided into three sub-categories:
9.2.1- ‘Active Regulatory Members’ are those which are interested in the ‘regulatory’ activities of the Association.
9.2.2- ‘Active Incubator Members’ those which are involved in technology transfer, incubation or acceleration of translational research and interested in the ‘regulatory’ activities of the association. For those members, one fee is due per incubated project.
9.2.3- ‘Active Partnering Platform Members’ are those which are interested in R&D activities as well as being put into contact with other actors in the microbiome and health area.
9.3- ‘Associate Members’ are any academic or public research entities that have developed expertise in the field of research or development of new therapeutic and diagnostic modalities emerging from microbiome science and wishing to participate in the realization of the overall goal of the Association.
ARTICLE 10 – APPLICABLE LAW
The Website and its Content are governed by French laws, and any dispute relating thereto is subject to the jurisdiction of the competent French courts.