Common use of Publication of results Clause in Contracts

Publication of results. The sponsor undertakes to publish the results of the present clinical trial. Said publication shall obligatorily be sent to the CEICs involved in the performance of the clinical trial and the principal investigators for their knowledge. The Principal Investigator shall be free to present the results in an appropriate scientific meeting and/or publish them in a prestigious magazine, undertaking to submit to the Sponsor a copy of the manuscript or original, with sufficient notice, for review and comment of the content contained in such communication/publications in the term stated in the protocol or otherwise within 30 days from receipt thereof. The investigator undertakes to comply with the provisions of the study protocol relating to the publication of data, undertaking not to publish/disseminate those obtained in the centre, until the study data has been published as a whole. If so requested by the Sponsor, in order to properly secure the protection of inventions or developments arising from the trial, the Principal Investigator agrees to delay the submission of the proposed publication for a period not exceeding six (6) months. The sponsor undertakes not to impede and/or hinder the dissemination of those results that, being scientifically sound and unquestionable, reveal the lack of efficacy or adverse effects of the treatment. The Sponsor shall be bound to comply fully with Article 38 of publications of the Spanish Royal Decree 223/2004, of 6 February regulating clinical trials with drugs. In the event that after nine (9) months of the presentation of the final report of the Trial to the Competent Authorities, in accordance with article 27.3 of the Royal Decree 223/2004 for the performance of clinical trials with drugs, the Sponsor does not prove the initiation of the publication of process of the results, these may be made public in the Program for Clinical Studies of Drugs and Health Products (Programa de Estudios Clínicos de Medicamentos y Productos Sanitarios; PECME) in the Regional Community of Valencia (PECME) of the Regional Health Ministry’s website.

Publication of results. The sponsor undertakes Sponsor is committed to publish the results of the present this clinical trial. Said Such publication shall obligatorily will be necessarily sent to the CEICs involved CEIm implied in the performance conduct of the clinical trial and the principal investigators Principal Investigators for their knowledge. The Principal Investigator shall be free to may present the results in an appropriate at relevant scientific meeting meetings and/or publish them in a prestigious magazinemagazines of acknowledged prestige, hereby undertaking to submit to provide the Sponsor with a copy or original of the manuscript or original, text with sufficient notice, for review notice so that the latter has time to read such information and comment the contents of the content contained publication in such communication/publications in order to submit any comments about the term stated in the protocol or otherwise contents within a deadline of 30 days computed from receipt thereofthe date the document is received. The investigator undertakes will respect the agreements established in the Protocol, which especially refer to comply with the provisions of the study protocol relating data publication, and commit to the publication of data, undertaking not to publish/disseminate those disclose the data obtained in at the centresite, until the study data has have been published as a whole. If the Sponsor so requested by the Sponsorrequests, in order to properly secure the ensure appropriate protection of any inventions or developments arising stemming from the trial, the Principal Investigator agrees to delay the submission presentation of the proposed publication publication, for a period not exceeding six (6) 6 months. The sponsor undertakes Sponsor is committed to not to impede and/or hinder the dissemination of those the joint results that, being scientifically sound solid and unquestionable, reveal the lack absence of efficacy or adverse effects of the treatment. The Sponsor shall be bound is required to fully comply fully with Article 38 42 of publications of the Spanish Royal Decree 223/20041090/2015, of 6 February 4, regulating clinical trials with drugsmedicines. In the event that after If nine (9) months of after the presentation of the final report notification of the Trial final report to the Competent Authoritiesrelevant authorities, in accordance with article 27.3 pursuant to Article 30 of the Royal Decree 223/2004 for 1090/2015 on the performance conduct of clinical trials with drugsmedicines, the Sponsor does not prove the initiation of certify that the publication of process of has been processed, the results, these results may be made public in through the Program for Clinical Studies of Drugs Medicines and Health Products (Programa de Estudios Clínicos de Medicamentos y Productos Sanitarios; PECME) in the Regional Community of Valencia (PECME) Medical Devices Research Network of the Regional Valencian Community, the “IMEPS Network”, on the website of the Conselleria de Sanitat [Valencian Government's Health Ministry’s websiteDepartment].

Publication of results. The sponsor undertakes to publish the results of the present clinical trial. Said publication shall obligatorily be sent to the CEICs DRECs involved in the performance of the clinical trial and the principal investigators for their knowledge. The Principal Investigator shall be free to present the results in an appropriate scientific meeting and/or publish them in a prestigious magazine, undertaking to submit to the Sponsor a copy of the manuscript or original, with sufficient notice, for so that the Sponsor may have the chance to review and comment of on the content contained in of such communication/publications in the term stated in the protocol Protocol or otherwise within 30 days from receipt thereof. The investigator undertakes to comply with the provisions of the study trial protocol relating to the publication of data, undertaking not to publish/disseminate those obtained in the centresite, until the study data has been published as a whole. If so requested by the Sponsor, in order to properly secure the protection of inventions or developments arising from the trial, the Principal Investigator agrees to delay the submission of the proposed publication for a period not exceeding six (6) months. The sponsor Sponsor undertakes not to impede and/or hinder the dissemination of those results that, being scientifically sound and unquestionable, reveal the lack of efficacy or adverse effects of the treatment. The Sponsor shall be bound to comply fully with Article 38 42 of publications of the Spanish Royal Decree 223/20041090/2015, of 6 February 4 December regulating clinical trials with drugs. In the event that after nine (9) months of the presentation of the final report of the Trial to the Competent Authorities, in accordance with article 27.3 30 of the Royal Decree 223/2004 1090/2015 for the performance of clinical trials with drugs, the Sponsor does not prove the initiation of the results publication of process of the resultsprocess, these may be made public in the Program for Clinical Studies of Drugs and Health Products Medical Devices (Programa de Estudios Clínicos de Medicamentos y Productos Sanitarios; PECME) in the Regional Community of Valencia (PECME) on the website of the Regional Health Ministry’s websiteConselleria de Sanitat.

Publication of results. The sponsor undertakes to publish the results of the present clinical trial. Said publication shall obligatorily be sent to the CEICs involved in the performance of the clinical trial and the principal investigators for their knowledge. The Principal Investigator shall be free to present the results in an appropriate scientific meeting and/or publish them in a prestigious magazine, undertaking to submit to the Sponsor a copy of the manuscript or original, with sufficient notice, for review and comment of the content contained in such communication/publications in publications. This shall be done within the term period stated in the protocol Protocol, or otherwise else, within 30 days from receipt thereof. The investigator undertakes to comply with the provisions of the study protocol relating to the publication of data, undertaking not to publish/disseminate those obtained in the centre, until the study data has been published as a whole. If so requested by the Sponsor, in order to properly secure the protection of inventions or developments arising from the trialstudy, the Principal Investigator agrees to delay the submission of the proposed publication for a period not exceeding six (6) months. The sponsor undertakes not to impede and/or hinder the dissemination of those results that, being scientifically sound and unquestionable, reveal the lack of efficacy or adverse effects of the treatment. The Sponsor shall be bound to comply fully with Article 38 of publications of the Spanish Royal Decree 223/2004, of 6 February regulating clinical trials with drugs. In the event that after nine (9) months of from the presentation of the final report of the Trial Final Report to the Competent relevant Authorities, in accordance sccordance with article 27.3 8.2 of the Royal Decree 223/2004 for the performance Order SAS/3470/2009 of clinical trials with drugsDecember 16, the Sponsor does not prove the initiation start of the publication of process processing of the resultspublication, these the results may be made public in the Program for Clinical Studies of Drugs and Health Products (Programa de Estudios Clínicos de Medicamentos y Productos Sanitarios; PECME) in the Regional Community of Valencia (PECME) of the Regional Health Ministry’s website.