Common use of Commencement and Term Clause in Contracts

Commencement and Term. This Contract will come into force on the day it is signed and will endure until the end of the TRIALS, without prejudice to the provisions of Clause Nine. For this purpose, the TRIALS will not be understood to be finalized until the PARTIES have performed all their obligations arising under this Contract. The TRIALS will not, in any case whatsoever, commence until the CEIm has issued the relevant favorable opinion and the mandatory authorization is issued by the Spanish Medications and Healthcare Products Agency (hereinafter AEMPS) under the terms of Royal Decree 1090/2015, and any other authorization which, as appropriate, may be required by the applicable legislation. The effectiveness of this contract is subject to obtaining the aforementioned authorizations. The planned term for the TRIALS is   months, as provided for in the PROTOCOL. Legislation on clinical trials: Law 10/2013, of 24 July, bringing Directives 2010/84/EU of the European Parliament and of the Council, of 15 December 2010, on pharmacovigilance, and 2011/62/EU of the European Parliament and of the Council, of 8 June 2011, on prevention of the entry into the legal supply chain of falsified medicinal products, into the Spanish legal system, and amending Law 29/2006, of 26 July, on the guarantees and rational use of medicines and healthcare products. Royal Legislative Decree 01/2015, of 24 July, approving the combined text of the Guarantees and rational use of medicines and healthcare products act. Royal Decree 1090/2015, of 4 December, regulating clinical trials with medications, Research with Medications Ethics Committees and the Spanish Clinical Trials Registry (hereinafter, RD 1090/2015). Royal Decree 1015/2009, of 19 June, regulating the availability of medications under special circumstances. Decree 39/1994, of 28 April, regulating the powers of the Madrid Community with respect to clinical trials with medications. Regulation (EU) 2016/679 of the European Parliament and of the Council, of 27 April 2016, relating to the protection of natural persons with regard to the processing of personal data and on the free movement of such data and repealing Directive 95/46/EC (General Data Protection Regulation), and Organic Law 3/2018, of 5 December, on Personal Data Protection and guarantee of digital rights, along with the remainder of current regulations relating to personal data protection which may be applicable. Law 41/2002, of 14 November, on basic regulation of patient autonomy and on the rights and obligations with regard to clinical information and documentation. Law 14/2007, of 3 July, on biomedical research, and Royal Decree 1716/2011, of 18 November, establishing the basic requirements for biobank authorization and operation for the purposes of biomedical research and processing biological samples of human origin, and regulating the operation and organization of the National Biobank Registry for biomedical research, biological samples of human origin, and processing biological samples of human origin, which have been obtained, directly or indirectly, as a result of the TRIALS and, in particular, as long as they are going to be used for the purpose of biomedical research once the trials have ended. Law 1/1998, of 2 March, on Foundations in the Madrid Community. In accordance with article 23, patrons may engage with the Foundation, either in their own name or on behalf of a third party, with prior authorization from the Foundations Protectorate. Law 53/1984, of 26 December, on incompatibilities for personnel in the service of Public Authorities, and Royal Decree 598/1985, of 30 April, on incompatibilities for personnel in the service of the Government and Social Security, and the Bodies, Organizations and Enterprises coming under them. The ICH standard (International Conference of Harmonization Guideline) for Good Clinical Practice (GCP): GCPE6 (R2). Basic ethical principles provided for in internationally accepted recommendations, including the Declaration of Helsinki, in its updated version. Ethical standards and the national and international anti-corruption legislation contained in the OECD Convention, signed on 21 November 1997, and also included in the Foreign Corrupt Practices Act (FCPA), which may be applicable to one or all of the PARTIES to this contract. Without prejudice to the foregoing, the PARTIES undertake, at all times, to respect and comply with the legislation applicable on signature of this Contract and during its term. If, during its performance, the relevant regulations are amended, they will automatically be understood to apply to the Contract, unless the relevant regulation provides for a transitory regime with a different application.

Commencement and Term. This Contract will come into force on the day it is signed and will endure until the end of the TRIALSSTUDY, without prejudice to the provisions of Clause NineCLAUSE EIGHT. For this purpose, the TRIALS STUDY will not be understood to be finalized until the PARTIES have performed all their obligations arising under this Contract. The TRIALS STUDY will not, in any case whatsoever, commence until the CEIm has issued the relevant favorable opinion and the mandatory authorization is issued by the Spanish Medications and Healthcare Products Agency (hereinafter AEMPS) under the terms of Royal Decree 1090/2015, and any other authorization which, as appropriate, may be required by the applicable legislation. The effectiveness of this contract is subject to obtaining the aforementioned authorizations. The planned term for the TRIALS STUDY is   …… months, as provided for in the PROTOCOL. Legislation on clinical trialsobservational studies: Law 10/2013Royal Decree 577/2013 of 26 July regulating the pharmacovigilance of medicines for human use. Articles 2.16 and 2.18 and CHAPTER VI of this RD are exempted. Royal Decree 957/2020, dated 3 November, regulating observational studies with medicinal products Order 730/2004, of 24 July30 June, bringing Directives 2010/84/EU which establishes the requirements for the performance of observational-type post authorization studies with medicines for human use in the European Parliament and Community of the CouncilMadrid Law 14/2007, of 15 December 2010, on pharmacovigilance, and 2011/62/EU of the European Parliament and of the Council, of 8 June 2011, on prevention of the entry into the legal supply chain of falsified medicinal products, into the Spanish legal system, and amending Law 29/2006, of 26 3 July, on the guarantees and rational use of medicines and healthcare products. Royal Legislative Decree 01/2015, of 24 July, approving the combined text of the Guarantees and rational use of medicines and healthcare products act. Royal Decree 1090/2015, of 4 December, regulating clinical trials with medications, Biomedical Research with Medications Ethics Committees and the Spanish Clinical Trials Registry (hereinafter, RD 1090/2015). Royal Decree 1015/2009, of 19 June, regulating the availability of medications under special circumstances. Decree 39/1994, of 28 April, regulating the powers of the Madrid Community with respect to clinical trials with medications. Regulation (EU) 2016/679 of the European Parliament and of the Council, of 27 April 2016, relating to the protection of natural persons with regard to the processing of personal data and on the free movement of such data and repealing Directive 95/46/EC (General Data Protection Regulation), and Organic Law 3/2018, of 5 December, on Personal Data Protection and guarantee of digital rights, along with the remainder of current regulations relating to personal data protection which may be applicable. Law 41/2002, of 14 12 November, on basic regulation of patient autonomy and on the rights and obligations with regard to clinical information and documentation. Law 14/2007, of 3 July, on biomedical research, and Royal Decree 1716/2011, of 18 November, establishing the basic requirements for biobank authorization and operation for the purposes of biomedical research and processing biological samples of human origin, and regulating the operation and organization of the National Biobank Registry for biomedical research, biological samples of human origin, and processing biological samples of human origin, which have been obtained, directly or indirectly, as a result of the TRIALS and, in particular, as long as they are going to be used for the purpose of biomedical research once the trials have ended. Law 1/1998, of 2 March, on Foundations in the Madrid Community. In accordance with article 23, patrons may engage with the Foundation, either in their own name or on behalf of a third party, with prior authorization from the Foundations Protectorate. Law 53/1984, of 26 December, on incompatibilities for personnel in the service of Public Authorities, and Royal Decree 598/1985, of 30 April, on incompatibilities for personnel in the service of the Government and Social Security, and the Bodies, Organizations and Enterprises coming under them. The ICH standard Standard (International Conference of Harmonization Guideline) for Good Clinical Practice (GCP): GCPE6 (R2). Basic ethical principles provided for in internationally accepted recommendations, including the Declaration of Helsinki, in its updated version. version Ethical standards and the national and international anti-corruption legislation contained in the OECD Convention, signed on 21 November 1997, and also included in the Foreign Corrupt Practices Act (FCPA), which may be applicable to one or all of the PARTIES to this contract. contract Without prejudice to the foregoing, the PARTIES undertake, at all times, to respect and comply with the legislation applicable on signature of this Contract and during its term. If, during its performance, the relevant regulations are amended, they will automatically be understood to apply to the Contract, unless the relevant regulation provides for a transitory regime with a different application.

Commencement and Term. This Contract will come into force on the day it is signed and will endure until the end of the TRIALSSTUDY, without prejudice to the provisions of Clause NineCLAUSE SEVEN. For this purpose, the TRIALS STUDY will not be understood to be finalized until the PARTIES have performed all their obligations arising under this Contract. The TRIALS STUDY will not, in any case whatsoever, commence until the CEIm has issued the relevant favorable opinion and the mandatory authorization is issued by the Spanish Medications and Healthcare Products Agency (hereinafter AEMPS) under the terms of Royal Decree 1090/2015, and any other authorization which, as appropriate, may be required by the applicable legislation. The effectiveness of this contract is subject to obtaining the aforementioned authorizations. The planned term for the TRIALS STUDY is   …… months, as provided for in the PROTOCOL. Legislation on clinical trials: Law 10/2013Royal Decree 577/2013 of 26 July regulating the pharmacovigilance of medicines for human use. Articles 2.16 and 2.18 and CHAPTER VI of this RD are exempted. Royal Decree 957/2020, dated 3 November, regulating observational studies with medicinal products Order 730/2004, of 24 July30 June, bringing Directives 2010/84/EU which establishes the requirements for the performance of observational-type post authorisation studies with medicines for human use in the European Parliament and Community of the CouncilMadrid Law 14/2007, of 15 December 2010, on pharmacovigilance, and 2011/62/EU of the European Parliament and of the Council, of 8 June 2011, on prevention of the entry into the legal supply chain of falsified medicinal products, into the Spanish legal system, and amending Law 29/2006, of 26 3 July, on the guarantees and rational use of medicines and healthcare products. Royal Legislative Decree 01/2015, of 24 July, approving the combined text of the Guarantees and rational use of medicines and healthcare products act. Royal Decree 1090/2015, of 4 December, regulating clinical trials with medications, Biomedical Research with Medications Ethics Committees and the Spanish Clinical Trials Registry (hereinafter, RD 1090/2015). Royal Decree 1015/2009, of 19 June, regulating the availability of medications under special circumstances. Decree 39/1994, of 28 April, regulating the powers of the Madrid Community with respect to clinical trials with medications. Regulation (EU) 2016/679 of the European Parliament and of the Council, of 27 April 2016, relating to the protection of natural persons with regard to the processing of personal data and on the free movement of such data and repealing Directive 95/46/EC (General Data Protection Regulation), and Organic Law 3/2018, of 5 December, on Personal Data Protection and guarantee of digital rights, along with the remainder of current regulations relating to personal data protection which may be applicable. Law 41/2002, of 14 12 November, on basic regulation of patient autonomy and on the rights and obligations with regard to clinical information and documentation. Law 14/2007, of 3 July, on biomedical research, and Royal Decree 1716/2011, of 18 November, establishing the basic requirements for biobank authorization and operation for the purposes of biomedical research and processing biological samples of human origin, and regulating the operation and organization of the National Biobank Registry for biomedical research, biological samples of human origin, and processing biological samples of human origin, which have been obtained, directly or indirectly, as a result of the TRIALS and, in particular, as long as they are going to be used for the purpose of biomedical research once the trials have ended. Law 1/1998, of 2 March, on Foundations in the Madrid Community. In accordance with article 23, patrons may engage with the Foundation, either in their own name or on behalf of a third party, with prior authorization authorisation from the Foundations Protectorate. Law 53/1984, of 26 December, on incompatibilities for personnel in the service of Public Authorities, and Royal Decree 598/1985, of 30 April, on incompatibilities for personnel in the service of the Government and Social Security, and the Bodies, Organizations and Enterprises coming under them. The ICH standard Standard (International Conference of Harmonization Guideline) for Good Clinical Practice (GCP): GCPE6 (R2). Basic ethical principles provided for in internationally accepted recommendations, including the Declaration of Helsinki, in its updated version. version Ethical standards and the national and international anti-corruption legislation contained in the OECD Convention, signed on 21 November 1997, and also included in the Foreign Corrupt Practices Act (FCPA), which may be applicable to one or all of the PARTIES to this contract. contract Without prejudice to the foregoing, the PARTIES undertake, at all times, to respect and comply with the legislation applicable on signature of this Contract and during its term. If, during its performance, the relevant regulations are amended, they will automatically be understood to apply to the Contract, unless the relevant regulation provides for a transitory regime with a different application.

Commencement and Term. This Contract will come into force on the day it is signed and will endure until the end of the TRIALS, without prejudice to the provisions of Clause Nine. For this purpose, the TRIALS will not be understood to be finalized until the PARTIES have performed all their obligations arising under this Contract. The TRIALS will not, in any case whatsoever, commence until the CEIm has issued the relevant favorable opinion and the mandatory authorization is issued by the Spanish Medications and Healthcare Products Agency (hereinafter AEMPS) under the terms of Royal Decree 1090/2015, and any other authorization which, as appropriate, may be required by the applicable legislation. The effectiveness of this contract is subject to obtaining the aforementioned authorizations. The planned term for the TRIALS is   ___ months, as provided for in the PROTOCOL. THREE. APPLICABLE REGULATIONS Legislation on clinical trials: Law 10/2013, of 24 July, bringing Directives 2010/84/EU of the European Parliament and of the Council, of 15 December 2010, on pharmacovigilance, and 2011/62/EU of the European Parliament and of the Council, of 8 June 2011, on prevention of the entry into the legal supply chain of falsified medicinal products, into the Spanish legal system, and amending Law 29/2006, of 26 July, on the guarantees and rational use of medicines and healthcare products. Royal Legislative Decree 01/2015, of 24 July, approving the combined text of the Guarantees and rational use of medicines and healthcare products act. Royal Decree 1090/2015, of 4 December, regulating clinical trials with medications, Research with Medications Ethics Committees and the Spanish Clinical Trials Registry (hereinafter, RD 1090/2015). Royal Decree 1015/2009, of 19 June, regulating the availability of medications under special circumstances. Decree 39/1994, of 28 April, regulating the powers of the Madrid Community with respect to clinical trials with medications. Regulation (EU) 2016/679 of the European Parliament and of the Council, of 27 April 2016, relating to the protection of natural persons with regard to the processing of personal data and on the free movement of such data and repealing Directive 95/46/EC (General Data Protection Regulation), and Organic Law 3/2018, of 5 December, on Personal Data Protection and guarantee of digital rights, along with the remainder of current regulations relating to personal data protection which may be applicable. Law 41/2002, of 14 November, on basic regulation of patient autonomy and on the rights and obligations with regard to clinical information and documentation. Law 14/2007, of 3 July, on biomedical research, and Royal Decree 1716/2011, of 18 November, establishing the basic requirements for biobank authorization and operation for the purposes of biomedical research and processing biological samples of human origin, and regulating the operation and organization of the National Biobank Registry for biomedical research, biological samples of human origin, and processing biological samples of human origin, which have been obtained, directly or indirectly, as a result of the TRIALS and, in particular, as long as they are going to be used for the purpose of biomedical research once the trials have ended. Law 1/1998, of 2 March, on Foundations in the Madrid Community. In accordance with article 23, patrons may engage with the Foundation, either in their own name or on behalf of a third party, with prior authorization from the Foundations Protectorate. Law 53/1984, of 26 December, on incompatibilities for personnel in the service of Public Authorities, and Royal Decree 598/1985, of 30 April, on incompatibilities for personnel in the service of the Government and Social Security, and the Bodies, Organizations and Enterprises coming under them. The ICH standard (International Conference of Harmonization Guideline) for Good Clinical Practice (GCP): GCPE6 (R2). Basic ethical principles provided for in internationally accepted recommendations, including the Declaration of Helsinki, in its updated version. Ethical standards and the national and international anti-corruption legislation contained in the OECD Convention, signed on 21 November 1997, and also included in the Foreign Corrupt Practices Act (FCPA), which may be applicable to one or all of the PARTIES to this contract. Without prejudice to the foregoing, the PARTIES undertake, at all times, to respect and comply with the legislation applicable on signature of this Contract and during its term. If, during its performance, the relevant regulations are amended, they will automatically be understood to apply to the Contract, unless the relevant regulation provides for a transitory regime with a different application.

Commencement and Term. This Contract will come into force on the day it is signed and will endure until the end of the TRIALSSTUDY, without prejudice to the provisions of Clause NineCLAUSE SEVEN. For this purpose, the TRIALS STUDY will not be understood to be finalized until the PARTIES have performed all their obligations arising under this Contract. The TRIALS STUDY will not, in any case whatsoever, commence until the CEIm has issued the relevant favorable opinion and the mandatory authorization is issued by the Spanish Medications and Healthcare Products Agency (hereinafter AEMPS) under the terms of Royal Decree 1090/2015, and any other authorization which, as appropriate, may be required by the applicable legislation. The effectiveness of this contract is subject to obtaining the aforementioned authorizations. The planned term for the TRIALS STUDY is   …… months, as provided for in the PROTOCOL. Legislation on clinical trials: Law 10/2013Royal Decree 577/2013 regulating the pharmacovigilance of medicines for human use Order SAS/3470/2009, dated 16 December, which publishes the guidelines on observational post-authorisation studies on medicines for human consumption. Order 730/2004, of 24 July, bringing Directives 2010/84/EU of the European Parliament and of the Council, of 15 December 2010, on pharmacovigilance, and 2011/62/EU of the European Parliament and of the Council, of 8 June 2011, on prevention of the entry into the legal supply chain of falsified medicinal products, into the Spanish legal system, and amending Law 29/2006, of 26 July, on the guarantees and rational use of medicines and healthcare products. Royal Legislative Decree 01/2015, of 24 July, approving the combined text of the Guarantees and rational use of medicines and healthcare products act. Royal Decree 1090/2015, of 4 December, regulating clinical trials with medications, Research with Medications Ethics Committees and the Spanish Clinical Trials Registry (hereinafter, RD 1090/2015). Royal Decree 1015/2009, of 19 30 June, regulating which establishes the availability requirements for the performance of medications under special circumstances. Decree 39/1994, observational-type post authorisation studies with medicines for human use in the Community of 28 April, regulating the powers of the Madrid Community with respect to clinical trials with medications. Regulation (EU) 2016/679 of the European Parliament and of the Council, of 27 April 2016, relating to the protection of natural persons with regard to the processing of personal data and on the free movement of such data and repealing Directive 95/46/EC (General Data Protection Regulation), and Organic Law 3/2018, of 5 December, on Personal Data Protection and guarantee of digital rights, along with the remainder of current regulations relating to personal data protection which may be applicable. Law 41/2002, of 14 12 November, on basic regulation of patient autonomy and on the rights and obligations with regard to clinical information and documentation. Law 14/2007, of 3 July, on biomedical research, and Royal Decree 1716/2011, of 18 November, establishing the basic requirements for biobank authorization and operation for the purposes of biomedical research and processing biological samples of human origin, and regulating the operation and organization of the National Biobank Registry for biomedical research, biological samples of human origin, and processing biological samples of human origin, which have been obtained, directly or indirectly, as a result of the TRIALS and, in particular, as long as they are going to be used for the purpose of biomedical research once the trials have ended. Biomedical Research Law 1/1998, of 2 March, on Foundations in the Madrid Community. In accordance with article 23, patrons may engage with the Foundation, either in their own name or on behalf of a third party, with prior authorization authorisation from the Foundations Protectorate. Law 53/1984, of 26 December, on incompatibilities for personnel in the service of Public Authorities, and Royal Decree 598/1985, of 30 April, on incompatibilities for personnel in the service of the Government and Social Security, and the Bodies, Organizations and Enterprises coming under them. The ICH standard Standard (International Conference of Harmonization Guideline) for Good Clinical Practice (GCP): GCPE6 (R2). Basic ethical principles provided for in internationally accepted recommendations, including the Declaration of Helsinki, in its updated version. version Ethical standards and the national and international anti-corruption legislation contained in the OECD Convention, signed on 21 November 1997, and also included in the Foreign Corrupt Practices Act (FCPA), which may be applicable to one or all of the PARTIES to this contract. contract Without prejudice to the foregoing, the PARTIES undertake, at all times, to respect and comply with the legislation applicable on signature of this Contract and during its term. If, during its performance, the relevant regulations are amended, they will automatically be understood to apply to the Contract, unless the relevant regulation provides for a transitory regime with a different application.

Commencement and Term. This Contract will come into force on the day it is signed and will endure until the end of the TRIALSCLINICAL TRIAL, without prejudice to the provisions of Clause NineCLAUSE NINE. For this purpose, the TRIALS CLINICAL TRIAL will not be understood to be finalized until the PARTIES have performed all their obligations arising under this Contract. The TRIALS CLINICAL TRIAL will not, in any case whatsoever, commence until the CEIm has issued the relevant favorable favourable opinion and the mandatory authorization is issued by the Spanish Medications and Healthcare Products Agency SPANISH MEDICATIONS AND HEALTHCARE PRODUCTS AGENCY (hereinafter AEMPS) under the terms of Royal Decree ROYAL DECREE 1090/2015, and any other authorization which, as appropriate, may be required by the applicable legislation. The effectiveness of this contract is subject to obtaining the aforementioned authorizations. The planned term for the TRIALS CLINICAL TRIAL is   …… months, as provided for in the PROTOCOL. Legislation on clinical trialsLegislationonclinicaltrials: Law 10/2013, of 24 July, bringing Directives 2010/84Directives2010/84/EU of the European Parliament and Parliamentand of the Council, of 15 December 2010, on pharmacovigilance, and 2011/62/EU of the European Parliament and of the Council, of 8 June 2011, on prevention of the entry into the legal supply chain of falsified medicinal products, into the Spanish legal system, and amending Law 29/2006, of 26 July, on the guarantees and rational use of medicines and healthcare products. Royal Legislative Decree 01/2015, of 24 July, approving the combined text of the Guarantees and rational use of medicines and healthcare products act. Royal Decree 1090/2015, of 4 December, regulating clinical trials with medications, Research with Medications Ethics Committees and the Spanish theSpanish Clinical Trials Registry (hereinafter, RD 1090/2015RD1090/2015). Royal Decree 1015/2009, of 19 June, regulating the availability of medications under special circumstances. Decree 39/1994, of 28 April, regulating the powers of the Madrid Community with respect to clinical trials with medications. Royal Decree 1591/2009, of 16 Octoberregulating medical devices Royal Decree 1616/2009, of 26 October, regulating active implantable medical devices Regulation (EU) 2016/679 of the European Parliament and of the Council, of 27 April 2016, relating to the protection of natural persons with regard to the processing of personal data and on the free movement of such data and repealing Directive 95/46/EC (General Data Protection Regulation), and Organic Law 3/2018, of 5 December, on Personal Data Protection and guarantee of digital rights, along with the remainder of current regulations relating to personal data protection which may be applicable. Law 41/2002, of 14 November, on basic regulation of patient autonomy and on the rights and obligations with regard to clinical information and documentation. Law 14/2007, of 3 July, on biomedical researchBiomedical Research, and Royal Decree 1716/20111716/2001, of 18 November, establishing the basic requirements for biobank Biobank authorization and operation for the purposes of biomedical research and processing biological samples of human origin, and regulating the operation and organization of the National Biobank Registry for biomedical research, biological samples of human origin, ,and processing biological samples of human origin, which have been obtained, directly or indirectly, as a result of the TRIALS and, in particular, as long as they are going to be used for the purpose of biomedical research once the trials have ended. Law 1/1998, of 2 March, on Foundations in the Madrid Community. In accordance with article 23, patrons may engage with the Foundation, either in their own name or on behalf of a third party, with prior authorization authorisation from the Foundations Protectorate. Law 53/1984, of 26 December, on incompatibilities for personnel in the service of Public Authorities, and Royal Decree 598/1985, of 30 April, on incompatibilities for personnel in the service of the Government and Social Security, and the Bodies, Organizations and Enterprises coming under them. The ICH standard Standard (International Conference of Harmonization Guideline) for Good Clinical Practice (GCP): GCPE6 (R2). Basic ethical principles provided for in internationally accepted recommendations, including the Declaration of Helsinki, in its updated version. version Ethical standards and the national and international anti-corruption legislation contained in the OECD Convention, signed on 21 November 1997, and also included in the Foreign Corrupt Practices Act (FCPA), which may be applicable to one or all of the PARTIES to this contract. contract Without prejudice to the foregoing, the PARTIES undertake, at all times, to respect and comply with the legislation applicable on signature of this Contract and during its term. If, during its performance, the relevant regulations are amended, they will automatically be understood to apply to the Contract, unless the relevant regulation provides for a transitory regime with a different application.

Commencement and Term. This Contract will come into force on the day it is signed and will endure until the end of the TRIALSCLINICAL TRIAL, without prejudice to the provisions of Clause Nine. For this purpose, the TRIALS CLINICAL TRIAL will not be understood to be finalized finalised until the PARTIES have performed all their obligations arising under this Contract. The TRIALS CLINICAL TRIAL will not, in any case whatsoever, commence until the CEIm has issued the relevant favorable favourable opinion and the mandatory authorization authorisation is issued by the Spanish Medications and Healthcare Products Agency (hereinafter AEMPS) under the terms of Royal Decree 1090/2015, and any other authorization authorisation which, as appropriate, may be required by the applicable legislation. The effectiveness of this contract is subject to obtaining the aforementioned authorizationsauthorisations. The planned term for the TRIALS CLINICAL TRIAL is   ___ months, as provided for in the PROTOCOL. THREE.- APPLICABLE REGULATIONS. Legislation on clinical trials: Law 10/2013, of 24 July, bringing Directives 2010/84/EU of the European Parliament and of the Council, of 15 December 2010, on pharmacovigilance, and 2011/62/EU of the European Parliament and of the Council, of 8 June 2011, on prevention of the entry into the legal supply chain of falsified medicinal products, into the Spanish legal system, and amending Law 29/2006, of 26 July, on the guarantees and rational use of medicines and healthcare products. Royal Legislative Decree 01/2015, of 24 July, approving the combined text of the Guarantees and rational use of medicines and healthcare products act. Royal Decree 1090/2015, of 4 December, regulating clinical trials with medications, Research with Medications Ethics Committees and the Spanish Clinical Trials Registry (hereinafter, RD 1090/2015). Royal Decree 1015/2009, of 19 June, regulating the availability of medications under special circumstances. Decree 39/1994, of 28 April, regulating the powers of the Madrid Community with respect to clinical trials with medications. Regulation (EU) 2016/679 of the European Parliament and of the Council, of 27 April 2016, relating to the protection of natural persons with regard to the processing of personal data and on the free movement of such data and repealing Directive 95/46/EC (General Data Protection Regulation), and Organic Law 3/2018, of 5 December, on Personal Data Protection and guarantee of digital rights, along with the remainder of current regulations relating to personal data protection which may be applicable. Law 41/2002, of 14 November, on basic regulation of patient autonomy and on the rights and obligations with regard to clinical information and documentation. Law 14/2007, of 3 July, on biomedical research, and Royal Decree 1716/20111716/2001, of 18 November, establishing the basic requirements for biobank authorization authorisation and operation for the purposes of biomedical research and processing biological samples of human origin, and regulating the operation and organization organisation of the National Biobank Registry for biomedical research, biological samples of human origin, and processing biological samples of human origin, which have been obtained, directly or indirectly, as a result of the TRIALS and, in particular, as long as they are going to be used for the purpose of biomedical research once the trials have ended. Law 1/1998, of 2 March, on Foundations in the Madrid Community. In accordance with article 23, patrons may engage with the Foundation, either in their own name or on behalf of a third party, with prior authorization authorisation from the Foundations Protectorate. Law 53/1984, of 26 December, on incompatibilities for personnel in the service of Public Authorities, and Royal Decree 598/1985, of 30 April, on incompatibilities for personnel in the service of the Government and Social Security, and the Bodies, Organizations Organisations and Enterprises coming under them. The ICH standard (International Conference of Harmonization Guideline) for Good Clinical Practice (GCP): GCPE6 (R2). Basic ethical principles provided for in internationally accepted recommendations, including the Declaration of Helsinki, in its updated version. Ethical standards and the national and international anti-corruption legislation contained in the OECD Convention, signed on 21 November 1997, and also included in the Foreign Corrupt Practices Act (FCPA), which may be applicable to one or all of the PARTIES to this contract. Without prejudice to the foregoing, the PARTIES undertake, at all times, to respect and comply with the legislation applicable on signature of this Contract and during its term. If, during its performance, the relevant regulations are amended, they will automatically be understood to apply to the Contract, unless the relevant regulation provides for a transitory regime with a different application.

Commencement and Term. This Contract will come into force on the day it is signed and will endure until the end of the TRIALS, without prejudice to the provisions of Clause Nine. For this purpose, the TRIALS will not be understood to be finalized until the PARTIES have performed all their obligations arising under this Contract. The TRIALS will not, in any case whatsoever, commence until the CEIm has issued the relevant favorable opinion and the mandatory authorization is issued by the Spanish Medications and Healthcare Products Agency (hereinafter AEMPS) under the terms of Royal Decree 1090/2015, and any other authorization which, as appropriate, may be required by the applicable legislationopinion. The effectiveness of this contract is subject to obtaining the aforementioned authorizationsauthorization. This study has the approval of the CE marking, which does not require the approval of the AEMPS. The planned term for the TRIALS is   ___ months, as provided for in the PROTOCOL. THREE. APPLICABLE REGULATIONS Legislation on clinical trials: Law 10/2013, of 24 July, bringing Directives 2010/84/EU of the European Parliament and of the Council, of 15 December 2010, on pharmacovigilance, and 2011/62/EU of the European Parliament and of the Council, of 8 June 2011, on prevention of the entry into the legal supply chain of falsified medicinal products, into the Spanish legal system, and amending Law 29/2006, of 26 July, on the guarantees and rational use of medicines and healthcare products. Royal Legislative Decree 01/2015, of 24 July, approving the combined text of the Guarantees and rational use of medicines and healthcare products act. Royal Decree 1090/2015, of 4 December, regulating clinical trials with medications, Research with Medications Ethics Committees and the Spanish Clinical Trials Registry (hereinafter, RD 1090/2015). Royal Decree 1015/2009, of 19 June, regulating the availability of medications under special circumstances. Decree 39/1994, of 28 April, regulating the powers of the Madrid Community with respect to clinical trials with medications. Royal Decree 1591/2009, of 16 October, regulating the healthcare products. The Royal Decree 1616/2009, of 26t October, regulating the implantable healthcare products. Circular 7/2004, relative to clinical research with healthcare products. Regulation (EU) 2016/679 of the European Parliament and of the Council, of 27 April 2016, relating to the protection of natural persons with regard to the processing of personal data and on the free movement of such data and repealing Directive 95/46/EC (General Data Protection Regulation), and Organic Law 3/2018, of 5 December, on Personal Data Protection and guarantee of digital rights, along with the remainder of current regulations relating to personal data protection which may be applicable. Law 41/2002, of 14 November, on basic regulation of patient autonomy and on the rights and obligations with regard to clinical information and documentation. Law 14/2007, of 3 July, on biomedical research, and Royal Decree 1716/2011, of 18 November, establishing the basic requirements for biobank authorization and operation for the purposes of biomedical research and processing biological samples of human origin, and regulating the operation and organization of the National Biobank Registry for biomedical research, biological samples of human origin, and processing biological samples of human origin, which have been obtained, directly or indirectly, as a result of the TRIALS and, in particular, as long as they are going to be used for the purpose of biomedical research once the trials have ended. Law 1/1998, of 2 March, on Foundations in the Madrid Community. In accordance with article 23, patrons may engage with the Foundation, either in their own name or on behalf of a third party, with prior authorization from the Foundations Protectorate. Law 53/1984, of 26 December, on incompatibilities for personnel in the service of Public Authorities, and Royal Decree 598/1985, of 30 April, on incompatibilities for personnel in the service of the Government and Social Security, and the Bodies, Organizations and Enterprises coming under them. The ICH standard (International Conference of Harmonization Guideline) for Good Clinical Practice (GCP): GCPE6 (R2). Basic ethical principles provided for in internationally accepted recommendations, including the Declaration of Helsinki, in its updated version. Ethical standards and the national and international anti-corruption legislation contained in the OECD Convention, signed on 21 November 1997, and also included in the Foreign Corrupt Practices Act (FCPA), which may be applicable to one or all of the PARTIES to this contract. Without prejudice to the foregoing, the PARTIES undertake, at all times, to respect and comply with the legislation applicable on signature of this Contract and during its term. If, during its performance, the relevant regulations are amended, they will automatically be understood to apply to the Contract, unless the relevant regulation provides for a transitory regime with a different application.

Commencement and Term. This Contract will come into force on the day it is signed and will endure until the end of the TRIALSCLINICAL TRIAL, without prejudice to the provisions of Clause NineCLAUSE NINE. For this purpose, the TRIALS CLINICAL TRIAL will not be understood to be finalized until the PARTIES have performed all their obligations arising under this Contract. The TRIALS CLINICAL TRIAL will not, in any case whatsoever, commence until the CEIm has issued the relevant favorable favourable opinion and the mandatory authorization is issued by the Spanish Medications and Healthcare Products Agency SPANISH MEDICATIONS AND HEALTHCARE PRODUCTS AGENCY (hereinafter AEMPS) under the terms of Royal Decree ROYAL DECREE 1090/2015, and any other authorization which, as appropriate, may be required by the applicable legislation. The effectiveness of this contract is subject to obtaining the aforementioned authorizations. The planned term for the TRIALS CLINICAL TRIAL is   …… months, as provided for in the PROTOCOL. Legislation on clinical trials: Law 10/2013, of 24 July, bringing Directives 2010/84Directives2010/84/EU of the European Parliament and Parliamentand of the Council, of 15 December 2010, on pharmacovigilance, and 2011/62/EU of the European Parliament and of the Council, of 8 June 2011, on prevention of the entry into the legal supply chain of falsified medicinal products, into the Spanish legal system, and amending Law 29/2006, of 26 July, on the guarantees and rational use of medicines and healthcare products. Royal Legislative Decree 01/2015, of 24 July, approving the combined text of the Guarantees and rational use of medicines and healthcare products act. Royal Decree 1090/2015, of 4 December, regulating clinical trials with medications, Research with Medications Ethics Committees and the Spanish theSpanish Clinical Trials Registry (hereinafter, RD 1090/2015RD1090/2015). Royal Decree 1015/2009, of 19 June, regulating the availability of medications under special circumstances. Decree 39/1994, of 28 April, regulating the powers of the Madrid Community with respect to clinical trials with medications. Royal Decree 1591/2009, of 16 October regulating medical devices Royal Decree 1616/2009, of 26 October, regulating active implantable medical devices Regulation (EU) 2016/679 of the European Parliament and of the Council, of 27 April 2016, relating to the protection of natural persons with regard to the processing of personal data and on the free movement of such data and repealing Directive 95/46/EC (General Data Protection Regulation), and Organic Law 3/2018, of 5 December, on Personal Data Protection and guarantee of digital rights, along with the remainder of current regulations relating to personal data protection which may be applicable. Law 41/2002, of 14 November, on basic regulation of patient autonomy and on the rights and obligations with regard to clinical information and documentation. Law 14/2007, of 3 July, on biomedical researchBiomedical Research, and Royal Decree 1716/20111716/2001, of 18 November, establishing the basic requirements for biobank Biobank authorization and operation for the purposes of biomedical research and processing biological samples of human origin, and regulating the operation and organization of the National Biobank Registry for biomedical research, biological samples of human origin, ,and processing biological samples of human origin, which have been obtained, directly or indirectly, as a result of the TRIALS and, in particular, as long as they are going to be used for the purpose of biomedical research once the trials have ended. Law 1/1998, of 2 March, on Foundations in the Madrid Community. In accordance with article 23, patrons may engage with the Foundation, either in their own name or on behalf of a third party, with prior authorization authorisation from the Foundations Protectorate. Law 53/1984, of 26 December, on incompatibilities for personnel in the service of Public Authorities, and Royal Decree 598/1985, of 30 April, on incompatibilities for personnel in the service of the Government and Social Security, and the Bodies, Organizations and Enterprises coming under them. The ICH standard Standard (International Conference of Harmonization Guideline) for Good Clinical Practice (GCP): GCPE6 (R2). Basic ethical principles provided for in internationally accepted recommendations, including the Declaration of Helsinki, in its updated version. version Ethical standards and the national and international anti-corruption legislation contained in the OECD Convention, signed on 21 November 1997, and also included in the Foreign Corrupt Practices Act (FCPA), which may be applicable to one or all of the PARTIES to this contract. contract Without prejudice to the foregoing, the PARTIES undertake, at all times, to respect and comply with the legislation applicable on signature of this Contract and during its term. If, during its performance, the relevant regulations are amended, they will automatically be understood to apply to the Contract, unless the relevant regulation provides for a transitory regime with a different application.

Commencement and Term. This Contract will come into force on the day it is signed and will endure until the end of the TRIALSCLINICAL TRIAL, without prejudice to the provisions of Clause NineCLAUSE NINE. For this purpose, the TRIALS CLINICAL TRIAL will not be understood to be finalized until the PARTIES have performed all their obligations arising under this Contract. The TRIALS CLINICAL TRIAL will not, in any case whatsoever, commence until the CEIm has issued the relevant favorable opinion and the mandatory authorization is issued by the Spanish Medications and Healthcare Products Agency SPANISH MEDICATIONS AND HEALTHCARE PRODUCTS AGENCY (hereinafter AEMPS) under the terms of Royal Decree ROYAL DECREE 1090/2015, and any other authorization which, as appropriate, may be required by the applicable legislation. The effectiveness of this contract is subject to obtaining the aforementioned authorizations. The planned term for the TRIALS CLINICAL TRIAL is   …… months, as provided for in the PROTOCOL. Legislation on clinical trialsCLINICAL TRIAL: Law 10/2013, of 24 July, bringing Directives 2010/84Directives2010/84/EU of the European Parliament and of the Council, of 15 December 2010, on pharmacovigilance, and 2011/62/EU of the European Parliament and of the Council, of 8 June 2011, on prevention of the entry into the legal supply chain of falsified medicinal products, into the Spanish legal system, and amending Law 29/2006, of 26 July, on the guarantees and rational use of medicines and healthcare products. Royal Legislative Decree 01/2015, of 24 July, approving the combined text of the Guarantees and rational use of medicines and healthcare products act. Royal Decree 1090/2015, of 4 December, regulating clinical trials with medications, Research with Medications Ethics Committees and the Spanish Register of Clinical Trials Registry Studies (hereinafter, RD 1090/2015RD1090/2015). Royal Decree 1015/2009, of 19 June, regulating the availability of medications under special circumstances. Decree 39/1994, of 28 April, regulating the powers of the Madrid Community with respect to clinical trials with medications. Regulation (EU) 2016/679 of the European Parliament and of the Council, of 27 April 2016, relating to the protection of natural persons with regard to the processing of personal data and on the free movement of such data and repealing Directive 95/46/EC (General Data Protection Regulation), and Organic Law 3/2018, of 5 December, on Personal Data Protection and guarantee of digital rights, along with the remainder of current regulations relating to personal data protection which may be applicable. Law 41/2002, of 14 November, on basic regulation of patient autonomy and on the rights and obligations with regard to clinical information and documentation. Law 14/2007, of 3 July, on biomedical researchBiomedical Research, and Royal Decree 1716/20111716/2001, of 18 November, establishing the basic requirements for biobank Biobank authorization and operation for the purposes of biomedical research and processing biological samples of human origin, and regulating the operation and organization of the National Biobank Registry for biomedical research, biological samples of human origin, and processing biological samples of human origin, which have been obtained, directly or indirectly, as a result of the TRIALS CLINICAL TRIAL and, in particular, as long as they are going to be used for the purpose of biomedical research once the trials trial have ended. Law 1/1998, of 2 March, on Foundations in the Madrid Community. In accordance with article 23, patrons may engage with the Foundation, either in their own name or on behalf of a third party, with prior authorization from the Foundations Protectorate. Law 53/1984, of 26 December, on incompatibilities for personnel in the service of Public Authorities, and Royal Decree 598/1985, of 30 April, on incompatibilities for personnel in the service of the Government and Social Security, and the Bodies, Organizations and Enterprises coming under them. The ICH standard Standard (International Conference of Harmonization Guideline) for Good Clinical Practice (GCP): GCPE6 (R2). Basic ethical principles provided for in internationally accepted recommendations, including the Declaration of Helsinki, in its updated version. version Ethical standards and the national and international anti-corruption legislation contained in the OECD Convention, signed on 21 November 1997, and also included in the Foreign Corrupt Practices Act (FCPA), which may be applicable to one or all of the PARTIES to this contract. contract Without prejudice to the foregoing, the PARTIES undertake, at all times, to respect and comply with the legislation applicable on signature of this Contract and during its term. If, during its performance, the relevant regulations are amended, they will automatically be understood to apply to the Contract, unless the relevant regulation provides for a transitory regime with a different application.

Commencement and Term. This Contract will come into force on the day it is signed and will endure until the end of the TRIALSSTUDY, without prejudice to the provisions of Clause NineCLAUSE NINE. For this purpose, the TRIALS STUDY will not be understood to be finalized until the PARTIES have performed all their obligations arising under this Contract. The TRIALS STUDY will not, in any case whatsoever, commence until the CEIm has issued the relevant favorable opinion and the mandatory authorization is issued by the Spanish Medications and Healthcare Products Agency (hereinafter AEMPS) under the terms of Royal Decree 1090/2015, and any other authorization which, as appropriate, may be required by the applicable legislation. The effectiveness of this contract is subject to obtaining the aforementioned authorizations. The planned term for the TRIALS STUDY is   …… months, as provided for in the PROTOCOL. Legislation on clinical trials: Law 10/2013Royal Decree 577/2013 regulating the pharmacovigilance of medicines for human use Order SAS/3470/2009, dated 16 December, which publishes the guidelines on observational post-authorization studies on medicines for human consumption. Order 730/2004, of 24 July30 June, bringing Directives 2010/84/EU which establishes the requirements for the performance of observational-type post authorization studies with medicines for human use in the European Parliament and Community of the CouncilMadrid Royal Decree 1345/2007, of 15 December 2010, on pharmacovigilance, and 2011/62/EU of the European Parliament and of the Council, of 8 June 2011, on prevention of the entry into the legal supply chain of falsified medicinal products, into the Spanish legal system, and amending Law 29/2006, of 26 July, on the guarantees and rational use of medicines and healthcare products. Royal Legislative Decree 01/2015, of 24 July, approving the combined text of the Guarantees and rational use of medicines and healthcare products act. Royal Decree 1090/2015, of 4 December, regulating clinical trials with medications, Research with Medications Ethics Committees and the Spanish Clinical Trials Registry (hereinafter, RD 1090/2015). Royal Decree 1015/2009, of 19 June11 October, regulating the availability of medications under special circumstances. Decree 39/1994procedure for authorization, of 28 April, regulating registration and the powers of the Madrid Community with respect to clinical trials with medications. conditions for dispensing medicines for human use and which are manufactured industrially Regulation (EU) 2016/679 of the European Parliament and of the Council, of 27 April 2016, relating to the protection of natural persons with regard to the processing of personal data and on the free movement of such data and repealing Directive 95/46/EC (General Data Protection Regulation), and Organic Law 3/2018, of 5 December, on Personal Data Protection and guarantee of digital rights, along with the remainder of current regulations relating to personal data protection which may be applicable. Law 41/2002, of 14 12 November, on basic regulation of patient autonomy and on the rights and obligations with regard to clinical information and documentation. Law 14/2007, of 3 July, on biomedical research, and Royal Decree 1716/2011, of 18 November, establishing the basic requirements for biobank authorization and operation for the purposes of biomedical research and processing biological samples of human origin, and regulating the operation and organization of the National Biobank Registry for biomedical research, biological samples of human origin, and processing biological samples of human origin, which have been obtained, directly or indirectly, as a result of the TRIALS and, in particular, as long as they are going to be used for the purpose of biomedical research once the trials have ended. Biomedical Research Law 1/1998, of 2 March, on Foundations in the Madrid Community. In accordance with article 23, patrons may engage with the Foundation, either in their own name or on behalf of a third party, with prior authorization from the Foundations Protectorate. Law 53/1984, of 26 December, on incompatibilities for personnel in the service of Public Authorities, and Royal Decree 598/1985, of 30 April, on incompatibilities for personnel in the service of the Government and Social Security, and the Bodies, Organizations and Enterprises coming under them. The ICH standard Standard (International Conference of Harmonization Guideline) for Good Clinical Practice (GCP): GCPE6 (R2). Basic ethical principles provided for in internationally accepted recommendations, including the Declaration of Helsinki, in its updated version. version Ethical standards and the national and international anti-corruption legislation contained in the OECD Convention, signed on 21 November 1997, and also included in the Foreign Corrupt Practices Act (FCPA), which may be applicable to one or all of the PARTIES to this contract. contract Without prejudice to the foregoing, the PARTIES undertake, at all times, to respect and comply with the legislation applicable on signature of this Contract and during its term. If, during its performance, the relevant regulations are amended, they will automatically be understood to apply to the Contract, unless the relevant regulation provides for a transitory regime with a different application.

Commencement and Term. This Contract will come into force on the day it is signed and will endure until the end of the TRIALSCLINICAL TRIAL, without prejudice to the provisions of Clause NineCLAUSE NINE. For this purpose, the TRIALS CLINICAL TRIAL will not be understood to be finalized until the PARTIES have performed all their obligations arising under this Contract. The TRIALS CLINICAL TRIAL will not, in any case whatsoever, commence until the CEIm has issued the relevant favorable favourable opinion and the mandatory authorization is issued by the Spanish Medications and Healthcare Products Agency SPANISH MEDICATIONS AND HEALTHCARE PRODUCTS AGENCY (hereinafter AEMPS) under the terms of Royal Decree ROYAL DECREE 1090/2015, and any other authorization which, as appropriate, may be required by the applicable legislation. The effectiveness of this contract is subject to obtaining the aforementioned authorizations. The planned term for the TRIALS CLINICAL TRIAL is   …… months, as provided for in the PROTOCOL. Legislation on clinical trials: Law 10/2013, of 24 July, bringing Directives 2010/84/EU of the European Parliament and of the Council, of 15 December 2010, on pharmacovigilance, and 2011/62/EU of the European Parliament and of the Council, of 8 June 2011, on prevention of the entry into the legal supply chain of falsified medicinal products, into the Spanish legal system, and amending Law 29/2006, of 26 July, on the guarantees and rational use of medicines and healthcare products. Royal Legislative Decree 01/2015, of 24 July, approving the combined text of the Guarantees and rational use of medicines and healthcare products act. Royal Decree 1090/2015, of 4 December, regulating clinical trials with medications, Research with Medications Ethics Committees and the Spanish Register of Clinical Trials Registry Studies (hereinafter, RD 1090/2015RD1090/2015). Royal Decree 1015/2009, of 19 June, regulating the availability of medications under special circumstances. Decree 39/1994, of 28 April, regulating the powers of the Madrid Community with respect to clinical trials with medications. Regulation (EU) 2016/679 of the European Parliament and of the Council, of 27 April 2016, relating to the protection of natural persons with regard to the processing of personal data and on the free movement of such data and repealing Directive 95/46/EC (General Data Protection Regulation), and Organic Law 3/2018, of 5 December, on Personal Data Protection and guarantee of digital rights, along with the remainder of current regulations relating to personal data protection which may be applicable. Law 41/2002, of 14 November, on basic regulation of patient autonomy and on the rights and obligations with regard to clinical information and documentation. Law 14/2007, of 3 July, on biomedical researchBiomedical Research, and Royal Decree 1716/20111716/2001, of 18 November, establishing the basic requirements for biobank Biobank authorization and operation for the purposes of biomedical research and processing biological samples of human origin, and regulating the operation and organization of the National Biobank Registry for biomedical research, biological samples of human origin, and processing biological samples of human origin, which have been obtained, directly or indirectly, as a result of the TRIALS CLINICAL TRIAL and, in particular, as long as they are going to be used for the purpose of biomedical research once the trials trial have ended. Law 1/1998, of 2 March, on Foundations in the Madrid Community. In accordance with article 23, patrons may engage with the Foundation, either in their own name or on behalf of a third party, with prior authorization from the Foundations Protectorate. Law 53/1984, of 26 December, on incompatibilities for personnel in the service of Public Authorities, and Royal Decree 598/1985, of 30 April, on incompatibilities for personnel in the service of the Government and Social Security, and the Bodies, Organizations and Enterprises coming under them. The ICH standard Standard (International Conference of Harmonization Guideline) for Good Clinical Practice (GCP): GCPE6 (R2). Basic ethical principles provided for in internationally accepted recommendations, including the Declaration of Helsinki, in its updated version. version Ethical standards and the national and international anti-corruption legislation contained in the OECD Convention, signed on 21 November 1997, and also included in the Foreign Corrupt Practices Act (FCPA), which may be applicable to one or all of the PARTIES to this contract. contract Without prejudice to the foregoing, the PARTIES undertake, at all times, to respect and comply with the legislation applicable on signature of this Contract and during its term. If, during its performance, the relevant regulations are amended, they will automatically be understood to apply to the Contract, unless the relevant regulation provides for a transitory regime with a different application.

Commencement and Term. This Contract will come into force on the day it is signed and will endure until the end of the TRIALS, without prejudice to the provisions of Clause Nine. For this purpose, the TRIALS will not be understood to be finalized until the PARTIES have performed all their obligations arising under this Contract. The TRIALS will not, in any case whatsoever, commence until the CEIm has issued the relevant favorable opinion and the mandatory authorization is issued by the Spanish Medications and Healthcare Products Agency (hereinafter AEMPS) under the terms of Royal Decree 1090/2015, and any other authorization which, as appropriate, may be required by the applicable legislationopinion. The effectiveness of this contract is subject to obtaining the aforementioned authorizationsauthorization. This study has the approval of the CE marking, which does not require the approval of the AEMPS. The planned term for the TRIALS is   months, as provided for in the PROTOCOL. Legislation on clinical trials: Law 10/2013, of 24 July, bringing Directives 2010/84/EU of the European Parliament and of the Council, of 15 December 2010, on pharmacovigilance, and 2011/62/EU of the European Parliament and of the Council, of 8 June 2011, on prevention of the entry into the legal supply chain of falsified medicinal products, into the Spanish legal system, and amending Law 29/2006, of 26 July, on the guarantees and rational use of medicines and healthcare products. Royal Legislative Decree 01/2015, of 24 July, approving the combined text of the Guarantees and rational use of medicines and healthcare products act. Royal Decree 1090/2015, of 4 December, regulating clinical trials with medications, Research with Medications Ethics Committees and the Spanish Clinical Trials Registry (hereinafter, RD 1090/2015). Royal Decree 1015/2009, of 19 June, regulating the availability of medications under special circumstances. Decree 39/1994, of 28 April, regulating the powers of the Madrid Community with respect to clinical trials with medications. Royal Decree 1591/2009, of 16 October, regulating the healthcare products. The Royal Decree 1616/2009, of 26t October, regulating the implantable healthcare products. Circular 7/2004, relative to clinical research with healthcare products. Regulation (EU) 2016/679 of the European Parliament and of the Council, of 27 April 2016, relating to the protection of natural persons with regard to the processing of personal data and on the free movement of such data and repealing Directive 95/46/EC (General Data Protection Regulation), and Organic Law 3/2018, of 5 December, on Personal Data Protection and guarantee of digital rights, along with the remainder of current regulations relating to personal data protection which may be applicable. Law 41/2002, of 14 November, on basic regulation of patient autonomy and on the rights and obligations with regard to clinical information and documentation. Law 14/2007, of 3 July, on biomedical research, and Royal Decree 1716/2011, of 18 November, establishing the basic requirements for biobank authorization and operation for the purposes of biomedical research and processing biological samples of human origin, and regulating the operation and organization of the National Biobank Registry for biomedical research, biological samples of human origin, and processing biological samples of human origin, which have been obtained, directly or indirectly, as a result of the TRIALS and, in particular, as long as they are going to be used for the purpose of biomedical research once the trials have ended. Law 1/1998, of 2 March, on Foundations in the Madrid Community. In accordance with article 23, patrons may engage with the Foundation, either in their own name or on behalf of a third party, with prior authorization from the Foundations Protectorate. Law 53/1984, of 26 December, on incompatibilities for personnel in the service of Public Authorities, and Royal Decree 598/1985, of 30 April, on incompatibilities for personnel in the service of the Government and Social Security, and the Bodies, Organizations and Enterprises coming under them. The ICH standard (International Conference of Harmonization Guideline) for Good Clinical Practice (GCP): GCPE6 (R2). Basic ethical principles provided for in internationally accepted recommendations, including the Declaration of Helsinki, in its updated version. Ethical standards and the national and international anti-corruption legislation contained in the OECD Convention, signed on 21 November 1997, and also included in the Foreign Corrupt Practices Act (FCPA), which may be applicable to one or all of the PARTIES to this contract. Without prejudice to the foregoing, the PARTIES undertake, at all times, to respect and comply with the legislation applicable on signature of this Contract and during its term. If, during its performance, the relevant regulations are amended, they will automatically be understood to apply to the Contract, unless the relevant regulation provides for a transitory regime with a different application.

Commencement and Term. This Contract will come into force on the day it is signed and will endure until the end of the TRIALS, without prejudice to the provisions of Clause Nine. For this purpose, the TRIALS will not be understood to be finalized until the PARTIES have performed all their obligations arising under this Contract. The TRIALS will not, in any case whatsoever, commence until the CEIm has issued the relevant favorable opinion and the mandatory authorization is issued by the Spanish Medications and Healthcare Products Agency (hereinafter hereinafter, AEMPS) under the terms of Royal Decree 1090/2015, and any other authorization which, as appropriate, may be required by the applicable legislation. The effectiveness of this contract is subject to obtaining the aforementioned authorizations. The planned term for the TRIALS is   months, as provided for in the PROTOCOL. Legislation on clinical trials: Law 10/2013, of 24 July, bringing Directives 2010/84/EU of the European Parliament and of the Council, of 15 December 2010, on pharmacovigilance, and 2011/62/EU of the European Parliament and of the Council, of 8 June 2011, on prevention of the entry into the legal supply chain of falsified medicinal products, into the Spanish legal system, and amending Law 29/2006, of 26 July, on the guarantees and rational use of medicines and healthcare products. Royal Legislative Decree 01/2015, of 24 July, approving the combined text of the Guarantees and rational use of medicines and healthcare products act. Royal Decree 1090/2015, of 4 December, regulating clinical trials with medications, Research with Medications Ethics Committees and the Spanish Clinical Trials Registry (hereinafter, RD 1090/2015). Royal Decree 1015/2009, of 19 June, regulating the availability of medications under special circumstances. Decree 39/1994, of 28 April, regulating the powers of the Madrid Community with respect to clinical trials with medications. Royal Decree 1591/2009, of 16 October, regulating the healthcare products. The Royal Decree 1616/2009, of 26t October, regulating the implantable healthcare products. Circular 7/2004, relative to clinical research with healthcare products. Regulation (EU) 2016/679 of the European Parliament and of the Council, of 27 April 2016, relating to the protection of natural persons with regard to the processing of personal data and on the free movement of such data and repealing Directive 95/46/EC (General Data Protection Regulation), and Organic Law 3/2018, of 5 December, on Personal Data Protection and guarantee of digital rights, along with the remainder of current regulations relating to personal data protection which may be applicable. Law 41/2002, of 14 November, on basic regulation of patient autonomy and on the rights and obligations with regard to clinical information and documentation. Law 14/2007, of 3 July, on biomedical research, and Royal Decree 1716/2011, of 18 November, establishing the basic requirements for biobank authorization and operation for the purposes of biomedical research and processing biological samples of human origin, and regulating the operation and organization of the National Biobank Registry for biomedical research, biological samples of human origin, and processing biological samples of human origin, which have been obtained, directly or indirectly, as a result of the TRIALS and, in particular, as long as they are going to be used for the purpose of biomedical research once the trials have ended. Law 1/1998, of 2 March, on Foundations in the Madrid Community. In accordance with article 23, patrons may engage with the Foundation, either in their own name or on behalf of a third party, with prior authorization from the Foundations Protectorate. Law 53/1984, of 26 December, on incompatibilities for personnel in the service of Public Authorities, and Royal Decree 598/1985, of 30 April, on incompatibilities for personnel in the service of the Government and Social Security, and the Bodies, Organizations and Enterprises coming under them. The ICH standard (International Conference of Harmonization Guideline) for Good Clinical Practice (GCP): GCPE6 (R2). Basic ethical principles provided for in internationally accepted recommendations, including the Declaration of Helsinki, in its updated version. Ethical standards and the national and international anti-corruption legislation contained in the OECD Convention, signed on 21 November 1997, and also included in the Foreign Corrupt Practices Act (FCPA), which may be applicable to one or all of the PARTIES to this contract. Without prejudice to the foregoing, the PARTIES undertake, at all times, to respect and comply with the legislation applicable on signature of this Contract and during its term. If, during its performance, the relevant regulations are amended, they will automatically be understood to apply to the Contract, unless the relevant regulation provides for a transitory regime with a different application.