Common use of RESULTS AND PUBLICATIONS Clause in Contracts

RESULTS AND PUBLICATIONS. All of the data, the results of the TRIALS, and all of the work and industrial and intellectual property rights arising from it, belong to the SPONSOR, with the PARTIES being subject to the provisions of the applicable legislation. This circumstance will not prevent the LEAD INVESTIGATOR from using the results in their non-commercial professional research and teaching activities, safeguarding the SPONSOR’s industrial and intellectual property rights and respecting the provisions of the PROTOCOL. In accordance with the provisions of RD 1090/2015, the SPONSOR undertakes to publish the results obtained, whether positive or negative, once the TRIALS have ended. This publication will take place in publicly accessible scientific media, preferably in scientific journals. If the final results of the TRIALS are not submitted for publication by the SPONSOR, the LEAD INVESTIGATOR may, for professional purposes and in scientific journals and publications, make such data, discoveries or inventions known, with, at least, a mention of the SPONSOR, in accordance with the following criteria: Trials with products not on the market: in the first year after their authorization and marketing in any country; Trials performed after marketing: in the year following the end of the TRIALS, unless it compromises publication in a medical journal subject to peer review or contravenes national legislation. The SPONSOR must receive a copy of the text proposed for publication and/or dissemination for review, in accordance with the provisions of the PROTOCOL and, in the event that no indications are made in that respect, at least forty-five (45) days before the despatch date to the scientific journal and, at least, twenty (20) days beforehand in the event that it is a summary. At any event, the LEAD INVESTIGATOR may only use the data with prior, express, written authorization from the SPONSOR. The PARTIES agree that the consideration provided for (i) is, in their experience, a just consideration in relation to the services provided; (ii) is not an incentive for, or in exchange for, past, present or future prescriptions, purchases, recommendations, use, obtaining a preferential formulaic status or dispensations of any of the SPONSOR’s products, or, in any way, conditional or any other similar activity; and (iii) does not involve an impairment to the judgment of the LEAD INVESTIGATOR and the HOSPITAL in relation to advising and caring for each one of the Subjects.

RESULTS AND PUBLICATIONS. All of the data, the results of the TRIALS, and all of the work and industrial and intellectual property rights arising from it, belong to the SPONSOR, with the PARTIES being subject to the provisions of the applicable legislation. This circumstance will not prevent the LEAD INVESTIGATOR and the FIBHULP from using the results in their non-commercial professional research and teaching activities, safeguarding the SPONSOR’s industrial and intellectual property rights and respecting the provisions of the PROTOCOL. In accordance with the provisions of RD 1090/2015, the SPONSOR undertakes to publish the results obtained, whether positive or negative, once the TRIALS have ended. This publication will take place in publicly accessible scientific media, preferably in scientific journals. journals If the final results of the TRIALS are not submitted for publication by the SPONSOR, the LEAD INVESTIGATOR may, for professional purposes and in scientific journals and publications, make such data, discoveries or inventions known, with, at least, a mention of the SPONSOR, in accordance with the following criteria: Trials with products not on the market: in the first year after their authorization and marketing in any country; Trials performed after marketing: in the year following the end of the TRIALS, unless it compromises publication in a medical journal subject to peer review or contravenes national legislation. The SPONSOR must receive a copy of the text proposed for publication and/or dissemination for review, in accordance with the provisions of the PROTOCOL and, in the event that no indications are made in that respect, at least forty-five (45) days before the despatch date to the scientific journal and, at least, twenty (20) days beforehand in the event that it is a summary. At any event, the LEAD INVESTIGATOR may only use the data with prior, express, written authorization authorisation from the SPONSOR. The PARTIES agree that the consideration provided for (i) is, in their experience, a just consideration in relation to the services provided; (ii) is not an incentive for, or in exchange for, past, present or future prescriptions, purchases, recommendations, use, obtaining a preferential formulaic status or dispensations of any of the SPONSOR’s products, or, in any way, conditional or any other similar activity; and (iii) does not involve an impairment to the judgment of the LEAD INVESTIGATOR and the HOSPITAL in relation to advising and caring for each one of the Subjects. The anti-corruption policy provides that none of the PARTIES’ employees, and any third party acting for them or in their name, may have any interest or commitment which comes into conflict with, or prevents them from, performing their obligations under this Contract. All work must be carried out with strict respect for, and compliance with, the applicable ethical standards and legislation. The PARTIES consider that behaving with integrity and transparency is essential, with a zero tolerance policy towards any corrupt practices. The PARTIES’ employees, and any third party acting in their name, will not make payments of any kind, under any circumstances, either directly or indirectly, to any of the PARTIES taking part in the STUDY for the purpose of obtaining an unfair advantage or unduly influencing any decision making. This concept includes payments, or promises to pay, in kind and/or in cash, and any other offer of goods or services. The FIBHULP will accurately record all financial transactions arising from this Contract and will, when requested to do so in writing, make the relevant documentation available to the SPONSOR allowing verification of compliance with the commitments included in this document.

RESULTS AND PUBLICATIONS. All of the data, the results of the TRIALS, and all of the work and industrial and intellectual property rights arising from it, belong to the SPONSOR, with the PARTIES being subject to the provisions of the applicable legislation. This circumstance will not prevent the LEAD INVESTIGATOR and the FIBHULP from using the results in their non-commercial professional research and teaching activities, safeguarding the SPONSOR’s industrial and intellectual property rights and respecting the provisions of the PROTOCOL. In accordance with the provisions of RD 1090/2015, the SPONSOR undertakes to publish the results obtained, whether positive or negative, once the TRIALS have ended. This publication will take place in publicly accessible scientific media, preferably in scientific journals. journals If the final results of the TRIALS are not submitted for publication by the SPONSOR, the LEAD INVESTIGATOR may, for professional purposes and in scientific journals and publications, make such data, discoveries or inventions known, with, at least, a mention of the SPONSOR, in accordance with the following criteria: Trials with products not on the market: in the first year after their authorization and marketing in any country; Trials performed after marketing: in the year following the end of the TRIALS, unless it compromises publication in a medical journal subject to peer review or contravenes national legislation. The SPONSOR must receive a copy of the text proposed for publication and/or dissemination for review, in accordance with the provisions of the PROTOCOL and, in the event that no indications are made in that respect, at least forty-five (45) days before the despatch date to the scientific journal and, at least, twenty (20) days beforehand in the event that it is a summary. At any event, the LEAD INVESTIGATOR may only use the data with prior, express, written authorization from the SPONSOR. The PARTIES agree that the consideration provided for (i) is, in their experience, a just consideration in relation to the services provided; (ii) is not an incentive for, or in exchange for, past, present or future prescriptions, purchases, recommendations, use, obtaining a preferential formulaic status or dispensations of any of the SPONSOR’s products, or, in any way, conditional or any other similar activity; and (iii) does not involve an impairment to the judgment of the LEAD INVESTIGATOR and the HOSPITAL in relation to advising and caring for each one of the Subjects. The anti-corruption policy provides that none of the PARTIES’ employees, and any third party acting for them or in their name, may have any interest or commitment which comes into conflict with, or prevents them from, performing their obligations under this Contract. All work must be carried out with strict respect for, and compliance with, the applicable ethical standards and legislation. The PARTIES consider that behaving with integrity and transparency is essential, with a zero tolerance policy towards any corrupt practices. The PARTIES’ employees, and any third party acting in their name, will not make payments of any kind, under any circumstances, either directly or indirectly, to any of the PARTIES taking part in the STUDY for the purpose of obtaining an unfair advantage or unduly influencing any decision making. This concept includes payments, or promises to pay, in kind and/or in cash, and any other offer of goods or services. The FIBHULP will accurately record all financial transactions arising from this Contract and will, when requested to do so in writing, make the relevant documentation available to the SPONSOR allowing verification of compliance with the commitments included in this document.