Common use of CANCELLATION OR SUSPENSION Clause in Contracts

CANCELLATION OR SUSPENSION. 9.3. The TRIAL may be cancelled or suspended by any of the Parties under any of the circumstances detailed in Article 27 of Royal Decree 1090/2015 and in any of the following cases: 9.3.1. Failure to comply with the basic obligations assumed by any of the Parties. 9.3.2. Failure to comply with or defective performance of the remaining obligations by another Party if such failure is not corrected within fifteen (15) days after receiving written notice from the other Party to comply therewith. 9.3.3. By mutual written agreement among the Parties. TERMINATION OF THE CONTRACT 9.4. The termination or suspension of the execution of the TRIAL will allow the termination of the Agreement by the Party not in breach of its contractual obligations. The PARTIES shall guarantee the safety of the subject at the end of the TRIAL, as well as the continuity of the treatment, on which account they will continue to provide the trial treatment to subjects in compliance with the provisions of Royal Decree 1015/2009, of 19 June 2009, regulating the availability of medications in special situations. If there is a request by the CEIm for continuation of treatment, the PARTIES shall agree on the supply taking into account the feasibility of production and the efficacy and safety data on the trial drug / treatment, TEN.- RESULTS AND PUBLICATIONS 10.1. All data, TRIAL results, and all work and industrial and intellectual property rights deriving from the TRIAL shall be the property of the SPONSOR. For these purposes, the Parties shall be subject to the provisions of the relevant laws. This circumstance shall not prevent the PRINCIPAL INVESTIGATOR(s) or the FIIS-FJD from using the results in their professional activities. The parties shall safeguard the industrial and/or intellectual property rights of the SPONSOR observing the provisions of the PROTOCOL. 10.2. As set forth in Royal Decree 1090/2015, the SPONSOR undertakes to publish the results obtained once the study is completed, whether they are positive or negative. These results will be published in open-access scientific media. 10.3. Should the final results of the STUDY not be submitted for publication by the SPONSOR, the PRINCIPAL INVESTIGATOR(s) may, for professional purposes, release said data, discoveries, or inventions to scientific journals and publications, mentioning at least the SPONSOR, in accordance with the following criteria: Pre-marketing trials: in the first year after authorization and sale in any country; Post-marketing trials: one year after the TRIAL is concluded, unless a commitment is made to publish in a peer-reviewed medical journal or in cases in which doing so is against national law. For the purposes of review, the SPONSOR shall receive the text proposed for publication and/or release according to the terms appearing in the Protocol. In the event of no indication to this effect, the SPONSOR shall receive the text at least forty-five (45) days before its submission to the scientific journal and, in case of an abstract, at least twenty (20) days before submission. In any event, the PRINCIPAL INVESTIGATOR(s) may only use this information if they have received prior written consent to do so from the SPONSOR. 10.4. The PARTIES agree that the expected remuneration (i) is fair according to their experience as concerns the services provided; (ii) does not constitute an incentive for or is in exchange for past, present, or future prescriptions, purchases, recommendations, use, or the granting of preferential formulaic status or dispensations of any of the SPONSOR’s products or is in any way contingent upon any similar activity; and (iii) does not require changes in the judgment of the PRINCIPAL INVESTIGATOR or HOSPITAL as concerns the advice and care delivered to the Subjects. ELEVEN. ANTI-CORRUPTION CLAUSE 11.1. The anti-corruption policy provides that no employee of the PARTIES or any third party acting for them or on their behalf shall have interests or commitments that may create a conflict or prevent them from fulfilling their obligations set forth in this Agreement. All the activities shall be carried out respecting and in strict observance of the ethical standards and applicable legislation. The PARTIES consider integrity and transparency to be essential and have a zero-tolerance policy for corrupt practices of any nature. 11.2. No employee of the PARTIES or any third parties acting on their behalf shall make any payments of any type, for any reason, either directly or indirectly, to any of the PARTIES participating in the TRIAL for the purpose of securing an improper advantage or to unduly influence any decisions. For these purposes, "payments" include payments and pledges for payment, in kind and/or in cash, as well as any other offer of goods or services. 11.3. The FOUNDATION shall keep reliable records of all financial transactions deriving from the present Agreement and will provide the SPONSOR, upon the latter’s written request, with the relevant documentation to verify fulfillment of the commitments appearing in this document.

CANCELLATION OR SUSPENSION. 9.3. The TRIAL may be cancelled or suspended by any of the Parties under any of the circumstances detailed in Article 27 of Royal Decree 1090/2015 and in any of the following cases: 9.3.1. Failure to comply with the basic obligations assumed by any of the Parties. 9.3.2. Failure to comply with or defective performance of the remaining obligations by another Party if such failure is not corrected within fifteen (15) days after receiving written notice from the other Party to comply therewith. 9.3.3. By mutual written agreement Agreement among the Parties. TERMINATION OF THE CONTRACT 9.4. The termination or suspension of the execution of the TRIAL will allow the termination of the Agreement by the Party not in breach of its contractual obligations. The PARTIES Parties shall guarantee the safety of the subject at the end of the TRIAL, as well as the continuity of the treatment, on which account they will continue to provide the trial treatment to subjects in compliance with the provisions of Royal Decree 1015/2009, of 19 June 2009, regulating the availability of medications in special situations. If there is a request by the CEIm for continuation of treatment, the PARTIES Parties shall agree on the supply taking into account the feasibility of production and the efficacy and safety data on the trial drug / treatment, TEN.- TEN. RESULTS AND PUBLICATIONS 10.1. All data, TRIAL results, and all work and industrial and intellectual property rights deriving from the TRIAL shall be the property of the SPONSOR. For these purposes, the Parties shall be subject to the provisions of the relevant laws. This circumstance shall not prevent the PRINCIPAL INVESTIGATOR(s) or the FIIS-FJD from using the results in their professional activities. The parties Parties shall safeguard the industrial and/or intellectual property rights of the SPONSOR observing the provisions of the PROTOCOL. 10.2. As set forth in Royal Decree 1090/2015, the SPONSOR undertakes to publish the results obtained once the study is completed, whether they are positive or negative. These results will be published in open-access scientific media. 10.3. Should the final results of the STUDY not be submitted for publication by the SPONSOR, the PRINCIPAL INVESTIGATOR(s) may, for professional purposes, release said data, discoveries, or inventions to scientific journals and publications, mentioning at least the SPONSOR, in accordance with the following criteria: Pre-marketing trials: in the first year after authorization and sale in any country; Post-marketing trials: one year after the TRIAL is concluded, unless a commitment is made to publish in a peer-reviewed medical journal or in cases in which doing so is against national law. For the purposes of review, the SPONSOR shall receive the text proposed for publication and/or release according to the terms appearing in the Protocol. In the event of no indication to this effect, the SPONSOR shall receive the text at least forty-five (45) days before its submission to the scientific journal and, in case of an abstract, at least twenty (20) days before submission. In any event, the PRINCIPAL INVESTIGATOR(s) may only use this information if they have received prior written consent to do so from the SPONSOR. 10.4. The PARTIES Parties agree that the expected remuneration (i) is fair according to their experience as concerns the services provided; (ii) does not constitute an incentive for or is in exchange for past, present, or future prescriptions, purchases, recommendations, use, or the granting of preferential formulaic status or dispensations of any of the SPONSOR’s products or is in any way contingent upon any similar activity; and (iii) does not require changes in the judgment of the PRINCIPAL INVESTIGATOR or HOSPITAL as concerns the advice and care delivered to the Subjects. ELEVEN. ANTI-CORRUPTION CLAUSE 11.1. The anti-corruption policy provides that no employee of the PARTIES Parties or any third party acting for them or on their behalf shall have interests or commitments that may create a conflict or prevent them from fulfilling their obligations set forth in this Agreement. All the activities shall be carried out respecting and in strict observance of the ethical standards and applicable legislation. The PARTIES Parties consider integrity and transparency to be essential and have a zero-tolerance policy for corrupt practices of any nature. 11.2. No employee of the PARTIES Parties or any third parties Parties acting on their behalf shall make any payments of any type, for any reason, either directly or indirectly, to any of the PARTIES Parties participating in the TRIAL for the purpose of securing an improper advantage or to unduly influence any decisions. For these purposes, "payments" include payments and pledges for payment, in kind and/or in cash, as well as any other offer of goods or services. 11.3. The FOUNDATION shall keep reliable records of all financial transactions deriving from the present Agreement and will provide the SPONSOR, upon the latter’s written request, with the relevant documentation to verify fulfillment fulfilment of the commitments appearing in this document.

CANCELLATION OR SUSPENSION. 9.3. The TRIAL may be cancelled or suspended by any of the Parties under any of the circumstances detailed in Article 27 of Royal Decree 1090/2015 and in any of the following cases: 9.3.1. Failure to comply with the basic obligations assumed by any of the Parties. 9.3.2. Failure to comply with or defective performance of the remaining obligations by another Party if such failure is not corrected within fifteen (15) days after receiving written notice from the other Party to comply therewith. 9.3.3. By mutual written agreement among the Parties. TERMINATION OF THE CONTRACT 9.4. The termination or suspension of the execution of the TRIAL will allow the termination of the Agreement by the Party not in breach of its contractual obligations. The PARTIES shall guarantee the safety of the subject at the end of the TRIAL, as well as the continuity of the treatment, on which account they will continue to provide the trial treatment to subjects in compliance with the provisions of Royal Decree 1015/2009, of 19 June 2009, regulating the availability of medications in special situations. If there is a request by the CEIm for continuation of treatment, the PARTIES shall agree on the supply taking into account the feasibility of production and the efficacy and safety data on the trial drug / treatment, TEN.- RESULTS AND PUBLICATIONS 10.1. All data, TRIAL results, and all work and industrial and intellectual property rights deriving from the TRIAL shall be the property of the SPONSOR. For these purposes, the Parties shall be subject to the provisions of the relevant laws. This circumstance shall not prevent the PRINCIPAL INVESTIGATOR(s) or the FIIS-FJD from using the results in their professional activities. The parties shall safeguard the industrial and/or intellectual property rights of the SPONSOR observing the provisions of the PROTOCOL. 10.2. As set forth in Royal Decree 1090/2015, the SPONSOR undertakes to publish the results obtained once the study is completed, whether they are positive or negative. These results will be published in open-access scientific media. 10.3. Should the final results of the STUDY not be submitted for publication by the SPONSOR, the PRINCIPAL INVESTIGATOR(s) may, for professional purposes, release said data, discoveries, or inventions to scientific journals and publications, mentioning at least the SPONSOR, in accordance with the following criteria: Pre-marketing trials: in the first year after authorization and sale in any country; Post-marketing trials: one year after the TRIAL is concluded, unless a commitment is made to publish in a peer-reviewed medical journal or in cases in which doing so is against national law. For the purposes of review, the SPONSOR shall receive the text proposed for publication and/or release according to the terms appearing in the Protocol. In the event of no indication to this effect, the SPONSOR shall receive the text at least forty-five (45) days before its submission to the scientific journal and, in case of an abstract, at least twenty (20) days before submission. In any event, the PRINCIPAL INVESTIGATOR(s) may only use this information if they have received prior written consent to do so from the SPONSOR. 10.4. The PARTIES agree that the expected remuneration (i) is fair according to their experience as concerns the services provided; (ii) does not constitute an incentive for or is in exchange for past, present, or future prescriptions, purchases, recommendations, use, or the granting of preferential formulaic status or dispensations of any of the SPONSOR’s products or is in any way contingent upon any similar activity; and (iii) does not require changes in the judgment of the PRINCIPAL INVESTIGATOR or HOSPITAL as concerns the advice and care delivered to the Subjects. ELEVEN. ANTI-CORRUPTION CLAUSE 11.1. The anti-corruption policy provides that no employee of the PARTIES or any third party acting for them or on their behalf shall have interests or commitments that may create a conflict or prevent them from fulfilling their obligations set forth in this Agreement. All the activities shall be carried out respecting and in strict observance of the ethical standards and applicable legislation. The PARTIES consider integrity and transparency to be essential and have a zero-tolerance policy for corrupt practices of any nature. 11.2. No employee of the PARTIES or any third parties acting on their behalf shall make any payments of any type, for any reason, either directly or indirectly, to any of the PARTIES participating in the TRIAL for the purpose of securing an improper advantage or to unduly influence any decisions. For these purposes, "payments" include payments and pledges for payment, in kind and/or in cash, as well as any other offer of goods or services. 11.3. The FOUNDATION shall keep reliable records of all financial transactions deriving from the present Agreement and will provide the SPONSOR, upon the latter’s written request, with the relevant documentation to verify fulfillment fulfilment of the commitments appearing in this document.

CANCELLATION OR SUSPENSION. 9.3. The TRIAL Trial may be cancelled or suspended by any either of the Parties under any of the circumstances detailed in Article 27 of Royal Decree 1090/2015 and in any of the following cases: 9.3.1. Failure to comply with the basic obligations assumed by any of either of the Parties. 9.3.2. Failure to comply with or defective performance of the remaining obligations by another Party if provided such failure is not corrected within fifteen (15) days after receiving written notice from the other Party to comply therewithof such a circumstance. 9.3.3. By mutual written agreement among between the Parties. TERMINATION OF THE CONTRACT 9.4. The termination Termination or suspension of the execution of the TRIAL will allow Trial shall be cause for the termination of the Agreement Contract by the Party that has not in breach of failed to comply with its contractual obligations. 9.5. The PARTIES Parties shall guarantee the safety of the subject at the end subjects upon completion of the TRIALTrial, as well as the continuity continuation of the their treatment, on which account they will continue to provide the trial treatment to subjects in and compliance with the provisions of Royal Decree 1015/2009, of 19 June 2009, regulating the availability of medications in special situationslegal regulations on this matter. If there is a request by the CEIm for continuation of treatment, the PARTIES shall agree on the supply taking into account the feasibility of production and the efficacy and safety data on the trial drug / treatment, TEN.- RESULTS AND PUBLICATIONS 10.1. All data, TRIAL Trial results, and all work and industrial and intellectual industrial-property rights deriving from the TRIAL Trial shall be the property of the SPONSORSponsor. For these purposes, the Parties shall be subject to the provisions of the relevant laws. This circumstance shall not prevent the PRINCIPAL INVESTIGATOR(sPrincipal Investigator(s) or the FIIS-FJD from using the results in their professional activities. The parties shall safeguard the industrial industrial- and/or intellectual intellectual-property rights of the SPONSOR observing Sponsor in adherence of the provisions contents of the PROTOCOL. 10.2. As set forth in Royal Decree 1090/2015, the SPONSOR undertakes Sponsor endeavors to publish the results obtained once the study is completed, whether they are be these results positive or negative. These results will be published in open-access scientific media. 10.3. Should the final results of the STUDY not be submitted for publication by the SPONSORSponsor, the PRINCIPAL INVESTIGATOR(sPrincipal Investigator(s) may, for professional purposes, release said data, discoveries, or inventions to scientific journals and other publications, mentioning at least the SPONSOR, in accordance with the Sponsor. The following criteriacriteria must be followed for such a release: Pre-marketing market trials: in the first year after authorization and sale in any country; Post-marketing market trials: one year after the TRIAL Trial is concluded, unless a commitment is made to publish in a peer-reviewed medical journal or in cases in which doing so is against national law. For the purposes of review, the SPONSOR Sponsor shall receive the text being proposed for publication and/or release according to the terms appearing in the Protocol. In the event of no indication to this effect, the SPONSOR Sponsor shall receive the text at least forty-five (45) days before its submission to the scientific journal and, in case of an abstract, at least twenty (20) days before submission. In any event, the PRINCIPAL INVESTIGATOR(sPrincipal Investigator(s) may only use this information if they have received prior written consent to do so from the SPONSOR. 10.4. The PARTIES agree that the expected remuneration (i) is fair according to their experience as concerns the services provided; (ii) does not constitute an incentive for or is in exchange for past, present, or future prescriptions, purchases, recommendations, use, or the granting of preferential formulaic status or dispensations of any of the SPONSOR’s products or is in any way contingent upon any similar activity; and (iii) does not require changes in the judgment of the PRINCIPAL INVESTIGATOR or HOSPITAL as concerns the advice and care delivered to the SubjectsSponsor. ELEVEN. ANTI-CORRUPTION CLAUSE 11.1. The anti-corruption policy provides determines that no employee of the PARTIES FIIS-FJD, HOSPITAL,__________ (Sponsor) or any third party acting for them or on their behalf of the Sponsor shall have interests or commitments that may create a conflict for or prevent them from fulfilling their interfere in the ethical and appropriate performance of the obligations set forth in this Agreement. All the present Contract as well as the activities carried out. The Contract shall be carried out respecting and executed in strict observance of the such ethical standards and in adherence of applicable legislation. The PARTIES consider __________(Sponsor) considers integrity and transparency to be essential and have has a zero-tolerance policy for corrupt practices of any nature. 11.2. No employee of the PARTIES FIIS-FJD, HOSPITAL,__________ (Sponsor) or any third parties acting on their behalf of the Sponsor shall make any payments of any typeenter into contact with or authorize, for any reason, either directly or indirectly, payments of any type to any of the PARTIES individuals participating in the TRIAL Trial for the purpose of securing an improper advantage or to unduly influence any decisions. For these purposes, "payments" include payments and pledges for payment, in kind and/or in cash, as well as any other offer of goods or services. 11.3. The FOUNDATION IIS-FJD shall keep reliable records of all financial transactions deriving from the present Agreement and Contract, and, upon written request from __________ (Sponsor), will provide the SPONSOR, upon the latter’s written request, Sponsor with the relevant documentation necessary to verify the fulfillment of the commitments appearing in this document.