Common use of Publication of results Clause in Contracts

Publication of results. The Sponsor is committed to publish the results of this clinical trial. Such publication will be necessarily sent to the CEIm implied in the conduct of the clinical trial and the Principal Investigators for their knowledge. The Principal Investigator may present the results at relevant scientific meetings and/or publish them in magazines of acknowledged prestige, hereby undertaking to provide the Sponsor with a copy or original of the text with sufficient notice so that the latter has time to read such information and the contents of the publication in order to submit any comments about the contents within a deadline of 30 days computed from the date the document is received. The investigator will respect the agreements established in the Protocol, which especially refer to data publication, and commit to not publish/disclose the data obtained at the site, until the study data have been published as a whole. If the Sponsor so requests, in order to ensure appropriate protection of any inventions or developments stemming from the trial, the Principal Investigator agrees to delay presentation of the proposed publication, for a period not exceeding 6 months. The Sponsor is committed to not impede and/or hinder the dissemination of the joint results that, being solid and unquestionable, reveal the absence of efficacy or adverse effects of the treatment. The Sponsor is required to fully comply with Article 42 of publications of Royal Decree 1090/2015, of February 4, regulating clinical trials with medicines. If nine (9) months after the notification of the Trial final report to the relevant authorities, pursuant to Article 30 of Royal Decree 1090/2015 on the conduct of clinical trials with medicines, the Sponsor does not certify that the publication has been processed, the results may be made public through the Medicines and Medical Devices Research Network of the Valencian Community, the “IMEPS Network”, on the website of the Conselleria de Sanitat [Valencian Government's Health Department]. 2.9.-

Publication of results. The Sponsor is committed sponsor undertakes to publish the results of this the present clinical trial. Such Said publication will shall obligatorily be necessarily sent to the CEIm implied CEICs involved in the conduct performance of the clinical trial and the Principal Investigators principal investigators for their knowledge. The Principal Investigator may shall be free to present the results at relevant in an appropriate scientific meetings meeting and/or publish them in magazines of acknowledged prestigea prestigious magazine, hereby undertaking to provide submit to the Sponsor with a copy or original of the text manuscript or original, with sufficient notice so that the latter has time to read such information notice, for review and the contents comment of the publication content contained in order to submit any comments about such communication/publications in the contents term stated in the protocol or otherwise within a deadline of 30 days computed from the date the document is receivedreceipt thereof. The investigator will respect undertakes to comply with the agreements established provisions of the study protocol relating to the publication of data, undertaking not to publish/disseminate those obtained in the Protocol, which especially refer to data publication, and commit to not publish/disclose the data obtained at the sitecentre, until the study data have has been published as a whole. If so requested by the Sponsor so requestsSponsor, in order to ensure appropriate properly secure the protection of any inventions or developments stemming arising from the trial, the Principal Investigator agrees to delay presentation the submission of the proposed publication, publication for a period not exceeding 6 six (6) months. The Sponsor is committed sponsor undertakes not to not impede and/or hinder the dissemination of the joint those results that, being solid scientifically sound and unquestionable, reveal the absence lack of efficacy or adverse effects of the treatment. The Sponsor is required shall be bound to comply fully comply with Article 42 38 of publications of the Spanish Royal Decree 1090/2015223/2004, of 6 February 4, regulating clinical trials with medicinesdrugs. If In the event that after nine (9) months after of the notification presentation of the final report of the Trial final report to the relevant authoritiesCompetent Authorities, pursuant to Article 30 in accordance with article 27.3 of the Royal Decree 1090/2015 on 223/2004 for the conduct performance of clinical trials with medicinesdrugs, the Sponsor does not certify that prove the initiation of the publication has been processedof process of the results, the results these may be made public through in the Medicines Program for Clinical Studies of Drugs and Medical Devices Research Network Health Products (Programa de Estudios Clínicos de Medicamentos y Productos Sanitarios; PECME) in the Regional Community of Valencia (PECME) of the Valencian Community, the “IMEPS Network”, on the website of the Conselleria de Sanitat [Valencian Government's Regional Health Department]Ministry’s website. 2.9.-2.8. -

Publication of results. The Sponsor is committed sponsor undertakes to publish the results of this the present clinical trial. Such Said publication will shall obligatorily be necessarily sent to the CEIm implied CEICs involved in the conduct performance of the clinical trial and the Principal Investigators principal investigators for their knowledge. The Principal Investigator may shall be free to present the results at relevant in an appropriate scientific meetings meeting and/or publish them in magazines of acknowledged prestigea prestigious magazine, hereby undertaking to provide submit to the Sponsor with a copy or original of the text manuscript or original, with sufficient notice so that the latter has time to read such information notice, for review and the contents comment of the publication content contained in order to submit any comments about such communication/publications. This shall be done within the contents within a deadline of 30 days computed from the date the document is received. The investigator will respect the agreements established period stated in the Protocol, which especially refer or else, within 30 days from receipt thereof. The investigator undertakes to data publicationcomply with the provisions of the study protocol relating to the publication of data, and commit undertaking not to not publish/disclose disseminate those obtained in the data obtained at the sitecentre, until the study data have has been published as a whole. If so requested by the Sponsor so requestsSponsor, in order to ensure appropriate properly secure the protection of any inventions or developments stemming arising from the trialstudy, the Principal Investigator agrees to delay presentation the submission of the proposed publication, publication for a period not exceeding 6 six (6) months. The Sponsor is committed sponsor undertakes not to not impede and/or hinder the dissemination of the joint those results that, being solid scientifically sound and unquestionable, reveal the absence lack of efficacy or adverse effects of the treatment. The Sponsor is required to fully comply with Article 42 of publications of Royal Decree 1090/2015, of February 4, regulating clinical trials with medicines. If In the event that after nine (9) months after from the notification presentation of the Trial final report Final Report to the relevant authoritiesAuthorities, pursuant to Article 30 in sccordance with article 8.2 of Royal Decree 1090/2015 on the conduct Order SAS/3470/2009 of clinical trials with medicinesDecember 16, the Sponsor does not certify that prove the publication has been processedstart of the processing of the publication, the results may be made public through in the Medicines Program for Clinical Studies of Drugs and Medical Devices Research Network Health Products (Programa de Estudios Clínicos de Medicamentos y Productos Sanitarios; PECME) in the Regional Community of Valencia (PECME) of the Valencian CommunityRegional Health Ministry’s website. 2.8.- Confidentiality and Data protection. Any information relating to the conduct of the study, whether previous or subsequent to the same, provided or obtained, is confidential. In the event that information is disclosed to a third party, this such party undertakes in writing to maintain confidentiality of the information on the same terms contained hereof. Finally, all the parties and collaborating staff shall take appropriate measures to maintain confidentiality of personal data of which they are aware as a result of the trial, preventing access to said data to unauthorized third parties. The CENTRE shall ensure confidentiality, and together with the PRINCIPAL INVESTIGATOR, shall restrict access to information to those assumptions necessary for the proper execution of the protocol. In this sense, strict observance must be made of: Spanish Organic Law 15/1999 of 13 December regulating Personal Data Protection, Law 41/2002 of 14 November, basic regulations and their rights and duties with regard to clinical information and documentation; and Law 1/2003 of 28 January regulating rights and patient information of the Regional Community of Valencia, as well as the Royal Decree 1720/2007 of 21 December by which the Regulation of development of the Organic Law 15/1999 of 13 December is approved, regulating personal data protection. Provided that section 2.7 herein is observed, the “IMEPS Network”CENTRE shall not be entitled to disclose or disseminate by any means the results, on data or information arising directly or indirectly from the website performance of the Conselleria de Sanitat [Valencian Government's Health Department]study not even for scientific purposes unless authorized in writing by the SPONSOR. 2.9.-2.9. - Filing of documentation. Medical histories of patients will have a permanent, dynamic and fast system to identify whether a patient is participating or has participated in a study. The CEIC, shall file all the documentation relating to its operation and activity. In the event of termination of the activity, the documentation must be kept in the institution for at least three years since the completion of the last evaluated study. In the event any legal proceedings are initiated, documentation in paper format shall be kept until a court decision is achieved. This documentation shall be filed preferably together, in a place that will guarantee the confidentiality of information during the time required to be filed. The obligations under the Law 15/1999 of 13 December regulating personal data protection and its further development (Royal Decree 1720/2007 of 21 December by which the Regulation of development of the Organic Law 15/1999 of 13 December is approved, regulating personal data protection) must be guaranteed. Relevant documentation shall be stored in secure places that guarantee that the documents remain complete and legible and shall be available to the competent authorities in case they are requested during the period provided for storage. When essential documents are stored in electronic format it must be guaranteed that any modification to the records is traceable, making able to know the initial and corrected data, as well as the date and signature of the author, including at least the following: Accreditation resolutions and further amendments. Curriculum Vitae of current members or from those who have belonged to the Committee. Meetings and reports of the Committee Standardized procedures of the activity of the Committee, current version and historical file. Record book. THIRD. PARTICIPANTS AND CONDUCTION SITE 3.1.- Participants. 3.1.1.- Sponsor 3.1.2.- Principal Investigator. The PRINCIPAL INVESTIGATOR shall ensure that all study participants and especially, the collaborators faithfully meet all the requirements set forth in this agreement and its exhibits, after being duly informed of the same. 3.1.3. – Collaborators The collaborative team of the INVESTIGATOR shall be approved and shall be able to successfully accomplish with the intended study, satisfying the requirements of the suitability certificate of Exhibit III. The Principal Investigator shall notify the CEIC and the Management of the Centre all the modifications and updates of the tasks of the team involved in the agreement. 3.1.4. - Other staff. If for the conduction of the present study staff unrelated to the CENTRE is required to be hired, it shall be notified to the CENTRE for inspection and access authorization and participation in the protocol by means of the appropriate accreditation. None of the requirements of this agreement constitutes an employment relationship between the CENTRE and the hired staff unrelated to the CENTRE participating in the study. 3.1.5. – Monitor. The Sponsor, appoints as monitor of the study Mr.   of the company (if appropriate)  . In the event the monitor is replaced, the Sponsor shall notify the identity of the new appointed monitor. 3.2. -

Publication of results. The Sponsor is committed sponsor undertakes to publish the results of this the present clinical trial. Such Said publication will shall obligatorily be necessarily sent to the CEIm implied DRECs involved in the conduct performance of the clinical trial and the Principal Investigators principal investigators for their knowledge. The Principal Investigator may shall be free to present the results at relevant in an appropriate scientific meetings meeting and/or publish them in magazines of acknowledged prestigea prestigious magazine, hereby undertaking to provide submit to the Sponsor with a copy or original of the text manuscript or original, with sufficient notice notice, so that the latter has time Sponsor may have the chance to read review and comment on the content of such information and communication/publications in the contents of term stated in the publication in order to submit any comments about the contents Protocol or otherwise within a deadline of 30 days computed from the date the document is receivedreceipt thereof. The investigator will respect undertakes to comply with the agreements established in provisions of the Protocoltrial protocol relating to the publication of data, which especially refer undertaking not to data publication, and commit to not publish/disclose the data disseminate those obtained at in the site, until the study data have has been published as a whole. If so requested by the Sponsor so requestsSponsor, in order to ensure appropriate properly secure the protection of any inventions or developments stemming arising from the trial, the Principal Investigator agrees to delay presentation the submission of the proposed publication, publication for a period not exceeding 6 six (6) months. The Sponsor is committed undertakes not to not impede and/or hinder the dissemination of the joint those results that, being solid scientifically sound and unquestionable, reveal the absence lack of efficacy or adverse effects of the treatment. The Sponsor is required shall be bound to comply fully comply with Article 42 of publications of Royal Decree 1090/2015, of February 4, 4 December regulating clinical trials with medicinesdrugs. If In the event that after nine (9) months after of the notification presentation of the final report of the Trial final report to the relevant authoritiesCompetent Authorities, pursuant to Article in accordance with article 30 of the Royal Decree 1090/2015 on for the conduct performance of clinical trials with medicinesdrugs, the Sponsor does not certify that prove the publication has been processed, initiation of the results publication process, these may be made public through in the Medicines Program for Clinical Studies of Drugs and Medical Devices Research Network (Programa de Estudios Clínicos de Medicamentos y Productos Sanitarios; PECME) in the Community of the Valencian Community, the “IMEPS Network”, Valencia (PECME) on the website of the Conselleria de Sanitat [Valencian Government's Health Department]. 2.9.-Sanitat.