Pursuant to Article 5(section 2). (letter c) of M.D. of 8 February 2013, the Principal Investigator has the right to disseminate and publish, without limitation, the results of the Trial obtained from the Entity, in accordance with the current laws on the confidentiality of sensitive data, data protection and intellectual property, and in accordance with the terms and conditions of this Agreement. To ensure that the data processing is correct and accurate, the Principal Investigator will send the Sponsor a copy of the document to be presented or published, at least 60 days before it is presented or published. If issues arise in relation to the scientific integrity of the document and/or issues regarding regulatory aspects, patents or the protection of intellectual property, the Parties will review the document together with the Principal Investigator in the in the 60 days following the re-examination of the document. The Principal Investigator will take into account the Sponsor’s suggestions in the publication or presentation, but only if necessary to protect the confidentiality of the personal data and information and to protect intellectual property, provided that the amendments do not conflict with the reliability of the data, or the rights, safety and well-being of the patients.
