Common use of Scope of Work A Clause in Contracts

Scope of Work A. The Institution and Principal Investigator shall perform the Study in accordance with a permission obtained from the State Institute for Drug Control, a concurring opinion of the Ethical Commission, the terms of this Agreement and the final protocol, including as it may be amended in accordance with the terms of this Agreement, for the Study entitled “ XXX” MK XXX, site number: XXX (the "Protocol") which is attached as Exhibit A and incorporated into this Agreement by reference. Institution certifies that, to its best knowledge, its facilities and patient population are adequate to perform the Study contemplated by this Agreement and the Protocol. Institution and the Principal Investigator agree that all aspects of the Study will be conducted in conformity with all applicable laws and regulations of the Czech Republic, namely Act No. 378/2007 Coll., on Pharmaceuticals and on amendments to certain related acts (the Act on Pharmaceuticals) (hereinafter: the “Act on Pharmaceuticals”), Act No. 372/2011 Coll., on Health Services and Conditions of their provision, as amended, including implementing legal regulations to these Acts (in particular Decree No. 226/2008 Coll., which determines good clinical practice and detailed conditions for clinical trials of pharmaceuticals), the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Good Clinical Practice: Consolidated Guideline and other generally accepted standards of good clinical practice. 2. Principal Investigator Principal Investigator will be responsible for the direction and supervision of all Study efforts in accordance with the Protocol and this Agreement. Principal Investigator and Institution shall provide all of the services contemplated herein through fully trained and competent Study Staff (as defined below) having a skill level appropriate for the tasks assigned to them and shall ensure that all Study Staff (as defined below)comply with the terms of this Agreement and the Protocol. “Study Staff” means (i) employees, officers, and directors of Institution, including without limitation the Principal Investigator, and (ii) any agents, contractors or other third parties approved by Sponsor in writing in accordance with Article 15. In the event that Principal Investigator leaves or is removed from the Institution, then Institution shall, within ten (10) days of becoming aware of such departure by Principal Investigator, provide written notice of such event to Sponsor. Any successor to Principal Investigator must be Smluvní strany se dohodly následovně: 1.

Scope of Work A. The Institution and Principal Investigator shall perform the Study in accordance with a permission obtained from the State Institute for Drug Control, a concurring opinion of the Ethical Commission, the terms of this Agreement and the final protocol, including as it may be amended in accordance with the terms of this Agreement, for the Study entitled “ XXX” MK XXXXXX“A Randomized Phase III study of pembrolizumab given concomitantly with chemoradiation and as maintenance therapy versus chemoradiation alone in subjects with locally advanced head and neck squamous cell carcinoma (KEYNOTE-412)”, protocol number XXXMK-3475-412 site number: XXX number XXX0701 (the "Protocol") which is attached as Exhibit A and incorporated into this Agreement by reference. Institution certifies that, to its best knowledge, its facilities and patient population are adequate to perform the Study contemplated by this Agreement and the Protocol. Institution and the Principal Investigator agree that all aspects of the Study will be conducted in conformity with all applicable laws and regulations of the Czech Republic, namely Act No. 378/2007 Coll., on Pharmaceuticals and on amendments to certain related acts (the Act on Pharmaceuticals) (hereinafter: the “Act on Pharmaceuticals”), Act No. 372/2011 Coll., on Care of Health Services and Conditions of their provisionServices, as amended, including implementing legal regulations to these Acts (in particular Decree No. 226/2008 Coll., which determines good clinical practice and detailed conditions for clinical trials of pharmaceuticals), the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Good Clinical Practice: Consolidated Guideline and other generally accepted standards of good clinical practice. 2. Principal Investigator Principal Investigator will be responsible for the direction and supervision of all Study efforts in accordance with the Protocol and this Agreement. Principal Investigator and Institution shall provide all of the services contemplated herein through fully trained and competent Study Staff (as defined below) having a skill level appropriate for the tasks assigned to them and shall ensure that all Study Staff (as defined below)comply below) comply with the terms of this Agreement and the Protocol. “Study Staff” means (i) employees, officers, and directors of Institution, including without limitation the Principal Investigator, and (ii) any agents, contractors or other third parties approved by Sponsor in writing in accordance with Article 15. In the event that Principal Investigator leaves or is removed from the Institution, then Institution shall, within ten (10) days of without any unnecessary delays after becoming aware of such departure by Principal Investigator, provide written notice of such event to Sponsor. Any successor to Principal Investigator must be Smluvní strany approved, in writing, by Sponsor and such successor shall be required to agree to all the terms and conditions of the Protocol and this Agreement and to sign each such document as evidence of such agreement (although failure to so sign will not relieve such successor from abiding with all the terms and conditions of the Protocol and this Agreement). In addition to this Agreement Sponsor will enter into a separate Contract for Work with Principal Investigator, in which the payments for the Principal Investigator and/or Study Staff shall be determined. Institution represents and warrants that it will not use in any capacity, in connection with any services to be performed under this Agreement, any individual who has been debarred pursuant to any applicable laws or regulations of the Czech Republic, including debarments under the United States Federal Food, Drug and Cosmetic Act, or exclusion from a United States federal healthcare program. Institution agrees to immediately inform Sponsor in writing if any person who is performing services hereunder is debarred or if any action, suit, claim, investigation or legal or administrative proceeding is pending, or, to the best of Institution's knowledge, is threatened, relating to the debarment of Institution or any person performing services hereunder. Principal Investigator represents and warrants that no action, suit, claim investigation or legal or administrative proceedings is pending or threatened relating to Principal Investigator’s debarment and Principal Investigator agrees to immediately inform Sponsor in writing if any such action, suit, claim, investigation or legal or administrative proceeding is threatened or commenced for Principal Investigator’s debarment. Institution agrees that Principal Investigator will complete, and will cause other applicable Study Staff such as subinvestigators to complete, a certification and disclosure form concerning financial interests or other conflicts of interests they may have related to the Study or Sponsor. If information collected on the form changes during the course of the Study or within one year after the last subject has completed the Study as specified in the Protocol, Principal Investigator and the other applicable Study Staff are required to inform Sponsor of such change. Preambule Zadavatel má zájem, aby se dohodly následovně: 1.ve Zdravotnickém zařízení hodnotila bezpečnost anebo účinnost Hodnoceného léčivého přípravku XXXMK-3475 (xxxx také xxx „Hodnocené léčivo“) a Zdravotnické zařízení a Hlavní zkoušející XXX Prof.

Scope of Work A. The Institution and Principal Investigator shall perform the Study in accordance with a witha permission obtained from the State Institute for Drug Control, a concurring opinion of the Ethical Commission, the terms of this Agreement and the final protocol, including as it may be amended in accordance with the terms of this Agreement, for the Study entitled “ XXX” MK XXX, site number: XXX (the "Protocol") which is attached as Exhibit A and incorporated into this Agreement by reference. Institution certifies that, to its best knowledge, its facilities and patient population are adequate to perform the Study contemplated by this Agreement and the Protocol. Institution and the Principal Investigator agree that all aspects of the Study will be conducted in conformity with all applicable laws and regulations of the Czech Republic, namely Act No. 378/2007 Coll., on Pharmaceuticals and on amendments to certain related acts (the Act on Pharmaceuticals) (hereinafter: the “Act on Pharmaceuticals”), Act No. 372/2011 Coll., on Health Services services and Conditions of their provision, as amended, including implementing legal regulations to these Acts (in particular Decree No. 226/2008 Coll., which determines good clinical practice and detailed conditions for clinical trials of pharmaceuticals), the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Good Clinical Practice: Consolidated Guideline and other generally accepted standards of good clinical practice. 2. Principal Investigator Principal Investigator will be responsible for the direction and supervision of all Study efforts in accordance with the Protocol and this Agreement. Principal Investigator and Institution shall provide all of the services contemplated herein through fully trained and competent Study Staff (as defined below) having a skill level appropriate for the tasks assigned to them and shall ensure that all Study Staff (as defined below)comply below) comply with the terms of this Agreement and the Protocol. “Study Staff” means (i) employeeszkoušející souhlasí s xxx, officers, and directors of Institution, including without limitation the Principal Investigator, and (ii) any agents, contractors or other third parties approved by Sponsor in writing in accordance with Article 15že veškeré povinnosti vůči Zadavateli vyplývající z této Smlouvy budou plněny vůči Společnosti jako zástupci Zadavatele. In the event that Principal Investigator leaves or is removed from the Institution, then Institution shall, within ten (10) days of becoming aware of such departure by Principal Investigator, provide written notice of such event to Sponsor. Any successor to Principal Investigator must be Smluvní strany se dohodly následovně: 1.

Scope of Work A. The Institution and Principal Investigator shall perform the Study in accordance with a permission obtained from the State Institute for Drug Control, a concurring opinion of the Ethical Commission, the terms of this Agreement and the final protocol, including as it may be amended in accordance with the terms of this Agreement, for the Study entitled “ “XXX” MK XXX”, protocol number XXX site number: number XXX (the "Protocol") which is attached as Exhibit A and incorporated into this Agreement by reference. Institution certifies that, to its best knowledge, its facilities and patient population are adequate to perform the Study contemplated by this Agreement and the Protocol. Institution and the Principal Investigator agree that all aspects of the Study will be conducted in conformity with all applicable laws and regulations of the Czech Republic, namely Act No. 378/2007 Coll., on Pharmaceuticals and on amendments to certain related acts (the Act on Pharmaceuticals) (hereinafter: the “Act on Pharmaceuticals”), Act No. 372/2011 Coll., on Care of Health Services and Conditions of their provisionServices, as amended, including implementing legal regulations to these Acts (in particular Decree No. 226/2008 Coll., which determines good clinical practice and detailed conditions for clinical trials of pharmaceuticals), the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Good Clinical Practice: Consolidated Guideline and other generally accepted standards of good clinical practice. 2. Principal Investigator Principal Investigator will be responsible for the direction and supervision of all Study efforts in accordance with the Protocol and this Agreement. Principal Investigator and Institution shall provide all of the services contemplated herein through fully trained and competent Study Staff (as defined below) having a skill level appropriate for the tasks assigned to them and shall ensure that all Study Staff (as defined below)comply below) comply with the terms of this Agreement and the Protocol. “Study Staff” means (i) employees, officers, and directors of Institution, including without limitation the Principal Investigator, and (ii) any agents, contractors or other third parties approved by Sponsor in writing in accordance with Article 15. In the event that Principal Investigator leaves or is removed from the Institution, then Institution shall, within ten (10) days of without any unnecessary delays after becoming aware of such departure by Principal Investigator, provide written notice of such event to Sponsor. Any successor to Principal Investigator must be approved, in writing, by Xxxxxxx and such successor shall be required to agree to all the terms and conditions of the Protocol and this Agreement and to sign each such document as evidence of such agreement (although failure to so sign will not relieve such successor from abiding with all the terms and conditions of the Protocol and this Agreement). In addition to this Agreement Sponsor will enter into a separate Contract for Work with Principal Investigator, in which the payments for the Principal Investigator and/or Study Staff shall be determined. Institution represents and warrants that it will not use in any capacity, in connection with any services to be performed under this Agreement, any individual who has been debarred pursuant to any applicable laws or regulations of the Czech Republic, including debarments under the United States Federal Food, Drug and Cosmetic Act, or exclusion from a United States federal healthcare program. Institution agrees to immediately inform Xxxxxxx in writing if any person who is performing services hereunder is debarred or if any action, suit, claim, investigation or legal or administrative proceeding is pending, or, to the best of Institution's knowledge, is threatened, relating to the debarment of Institution or any person performing services hereunder. Principal Investigator represents and warrants that no action, suit, claim investigation or legal or administrative proceedings is pending or threatened relating to Principal Investigator’s debarment and Principal Investigator agrees to immediately inform Xxxxxxx in writing if any such action, suit, claim, investigation or legal or administrative proceeding is threatened or commenced for Principal Investigator’s debarment. Institution agrees that Principal Investigator will complete, and will cause other applicable Study Staff such as subinvestigators to complete, a certification and disclosure form concerning financial interests or other conflicts of interests they may have related to the Study or Sponsor. If information collected on the form changes during the course of the Study or within one year after the last subject has completed the Study as specified in the Protocol, Principal Investigator and the other applicable Study Staff are required to inform Sponsor of such change. Preambule Zadavatel má zájem, aby se ve Zdravotnickém zařízení hodnotila bezpečnost anebo účinnost Hodnoceného léčivého přípravku XXX (xxxx také xxx „Hodnocené léčivo“) a Zdravotnické zařízení a Hlavní zkoušející XXX, Onkologická klinika, Fakultní nemocnice Olomouc xxxx zájem provést příslušnou klinickou studii (xxxx xxx „Studie“). Smluvní strany berou na vědomí a souhlasí, že společnost MERCK SHARP & DOHME, s.r.o., se sídlem Evropská 0000/00x, Xxxxx 0, 000 00, Xxxxx republika, IČ: 28462564, DIČ: CZ28462564, (xxxx xxx „Společnost“), bude vykonávat, v zastoupení společnosti MERCK SHARP & DOHME CORP, jako Zadavatele Studie prováděné na základě této Smlouvy, veškeré právní a jiné úkony, které jsou nutné, účelné nebo vhodné v souvislosti s plněním práv a povinností Zadavatele této Studie. Společnost tak jménem Zadavatele bude zejména činit veškeré ústní nebo písemné projevy vůle, jakož i přebírat veškeré písemnosti určené Zadavateli, přičemž Zdravotnické zařízení a Hlavní zkoušející souhlasí s xxx, že veškeré povinnosti vůči Zadavateli vyplývající z této Smlouvy budou plněny vůči Společnosti jako zástupci Zadavatele. Smluvní strany se dohodly následovně: 1.

Scope of Work A. The Institution and Principal Investigator shall perform the Study in accordance with a permission obtained from the State Institute for Drug Control, a concurring opinion of the Ethical Commission, the terms of this Agreement and the final protocol, including as it may be amended in accordance with the terms of this Agreement, for the Study entitled “ XXX" XXX ” MK XXX, site number: XXX (the "Protocol") which is attached as Exhibit A and incorporated into this Agreement by reference. Institution certifies that, to its best knowledge, its facilities and patient population are adequate to perform the Study contemplated by this Agreement and the Protocol. Institution and the Principal Investigator agree that all aspects of the Study will be conducted in conformity with all applicable laws and regulations of the Czech Republic, namely Act No. 378/2007 Coll., on Pharmaceuticals and on amendments to certain related acts (the Act on Pharmaceuticals) (hereinafter: the “Act on Pharmaceuticals”), Act No. 372/2011 Coll., on Health Services services and Conditions of their provision, as amended, including implementing legal regulations to these Acts (in particular Decree No. 226/2008 Coll., which determines good clinical practice and detailed conditions for clinical trials of pharmaceuticals), the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Good Clinical Practice: Consolidated Guideline and other generally accepted standards of good clinical practice. 2. Principal Investigator Principal Investigator will be responsible for the direction and supervision of all Study efforts in accordance with the Protocol and this Agreement. Principal Investigator and Institution shall provide all of the services contemplated herein through fully trained and competent Study Staff (as defined below) having a skill level appropriate for the tasks assigned to them and shall ensure that all Study Staff (as defined below)comply with the terms of this Agreement and the Protocolpísemnosti určené Zadavateli, přičemž Instituce a Hlavní zkoušející souhlasí s xxx, že veškeré povinnosti vůči Zadavateli vyplývající z této Smlouvy budou plněny vůči Společnosti jako zástupci Zadavatele. “Study Staff” means (i) employees, officers, and directors of Institution, including without limitation the Principal Investigator, and (ii) any agents, contractors or other third parties approved by Sponsor in writing in accordance with Article 15. In the event that Principal Investigator leaves or is removed from the Institution, then Institution shall, within ten (10) days of becoming aware of such departure by Principal Investigator, provide written notice of such event to Sponsor. Any successor to Principal Investigator must be Smluvní strany se dohodly následovně: 1. R ozsah činnosti A. Instituce a Hlavní zkoušející provedou Studii v souladu s povolením Státního ústavu pro kontrolu léčiv, souhlasným stanoviskem Etické komise, podmínkami této Smlouvy a konečného znění protokolu, a to včetně případných změn a doplňků učiněných v souladu s touto Smlouvou; pro Studii „XXX“ XXX, xxxxx centra: XXX (xxxx xxx „Protokol“), který tvoří nedílnou součást této Smlouvy jako její Příloha A. Instituce osvědčuje, že podle jejího nejlepšího vědomí, jsou její zařízení a populace pacientů vhodní pro provedení Studie předpokládané touto Smlouvou a Protokolem. Instituce a Hlavní zkoušející souhlasí, že veškeré aspekty této Studie budou provedeny v souladu se všemi příslušnými právními předpisy České republiky, zejména zákonem č. 378/2007 Sb., o léčivech a o změnách některých souvisejících zákonů v platném znění (zákon o léčivech) (xxxx xxx „Zákon o léčivech“), zákonem č.372/2011 Sb., o zdravotních službách a podmínkách jejich poskytování, v platném znění, včetně prováděcích předpisů k těmto zákonům (zejména vyhláškou č. 226/2008 Sb., kterou se stanoví správná klinická praxe a bližší podmínky klinického hodnocení léčiv), Mezinárodní konferencí o harmonizaci technických požadavků na registraci humánních léčivých přípravků Správná klinická praxe: Konsolidovaná směrnice (the International Conference on Harmonisation of Technical Requirements for Registration of

Scope of Work A. The Institution and Principal Investigator shall perform the Study in accordance with a permission obtained from the State Institute for Drug ControlControl issued on 26.4.2017 ref. number 36786/2017, a concurring opinion of the Multicentric ethical commission issued on, ref. number and Local Ethical CommissionCommission issued on 4.4.2017 , ref. number 4.4.2017/617. The permission of the State Institute for Drug Control and the concurring opinions of Multicentric and Local Ethical Commissions are attached as Apendix C to this Agreeement. The study shall also be conducted in compliance with the terms of this Agreement and the final protocol, including as it may be amended in accordance with the terms of this Agreement, for the Study entitled “ XXX” MK XXX Protocol Number XXX, site number: Site Number XXX (the "Protocol") which is attached as Exhibit A and incorporated into this Agreement by reference. Institution certifies that, to its best knowledge, its facilities and patient population are adequate to perform the Study contemplated by this Agreement and the Protocol. Institution and the Principal Investigator agree that all aspects of the Study will be conducted in conformity with all applicable laws and regulations of the Czech Republic, namely Act No. 378/2007 Coll., on Pharmaceuticals and on amendments to certain related acts (the Act on Pharmaceuticals) (hereinafter: the “Act on Pharmaceuticals”), Act No. Act No. 372/2011 Coll., on Health Services and Conditions of their provision, as amended, including implementing legal regulations to these Acts (in particular Decree Regulation No. 226/2008 Coll., which determines good clinical practice and detailed conditions for clinical trials of pharmaceuticals, as amended), the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Good Clinical Practice: Consolidated Guideline and other generally accepted standards of good clinical practice. 2. Principal Investigator Principal Investigator will be responsible for the direction and supervision of all Study efforts in accordance with the Protocol and this Agreement. Principal Investigator and Institution shall provide all of the services contemplated herein through fully trained and competent Study Staff (as defined below) having a skill level appropriate for the tasks assigned to them and shall ensure that all Study Staff (as defined below)comply with the terms of this Agreement and the Protocol. “Study Staff” means (i) employees, officers, and directors of Institution, including without limitation the Principal Investigator, and (ii) any agents, contractors or other third parties approved by Sponsor in writing in accordance with Article 15. In the event that Principal Investigator leaves or is removed from the Institution, then Institution shall, within ten (10) days of becoming aware of such departure by Principal Investigator, provide written notice of such event to Sponsor. Any successor to Principal Investigator must be Smluvní strany se dohodly následovně: 1.

Scope of Work A. The Institution and Principal Investigator shall perform the Study in accordance with a permission obtained from the State Institute for Drug ControlControl issued on. ref. number , a concurring opinion of the Multicentric ethical commission issued on , ref. number and Local Ethical CommissionCommission issued on , ref. number . The permission of the State Institute for Drug Control and the concurring opinions of Multicentric and Local Ethical Commissions are attached as Apendix C to this Agreeement. The study shall also be conducted in compliance with the terms of this Agreement and the final protocol, including as it may be amended in accordance with the terms of this Agreement, for the Study entitled “ XXX” MK XXX Protocol Number XXX, site number: Site Number XXX (the "Protocol") which is attached as Exhibit A and incorporated into this Agreement by reference. Institution certifies that, to its best knowledge, its facilities and patient population are adequate to perform the Study contemplated by this Agreement and the Protocol. Institution and the Principal Investigator agree that all aspects of the Study will be conducted in conformity with all applicable laws and regulations of the Czech Republic, namely Act No. 378/2007 Coll., on Pharmaceuticals and on amendments to certain related acts (the Act on Pharmaceuticals) (hereinafter: the “Act on Pharmaceuticals”), Act No. Act No. 372/2011 Coll., on Health Services and Conditions of their provision, as amended, including implementing legal regulations to these Acts (in particular Decree Regulation No. 226/2008 Coll., which determines good clinical practice and detailed conditions for clinical trials of pharmaceuticals, as amended), the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Good Clinical Practice: Consolidated Guideline and other generally accepted standards of good clinical practice. 2. Principal Investigator Principal Investigator will be responsible for the direction and supervision of all Study efforts in accordance with the Protocol and this Agreement. Principal Investigator and Institution shall provide all of the services contemplated herein through fully trained and competent Study Staff (as defined below) having a skill level appropriate for the tasks assigned to them and shall ensure that all Study Staff (as defined below)comply below) comply with the terms of this Agreement and the Protocol. “Study Staff” means (i) employees, officers, and directors of Institution, including without limitation the Principal Investigator, and (ii) any agents, contractors or other third parties approved by Sponsor in writing in accordance with Article 15. In the event that Principal Investigator leaves or is removed from the Institution, then Institution shall, within ten (10) days of becoming aware of such departure by Principal Investigator, provide written notice of such event to Sponsor. Any successor to Principal Investigator must be Smluvní strany se dohodly následovně: 1.

Scope of Work A. The Institution Provider of Medical Services and Principal Investigator shall perform the Study in accordance with a permission obtained from the State Institute for Drug Control, a concurring opinion of the Ethical Commission, the terms of this Agreement and the final protocol, including as it may be amended in accordance with the terms of this Agreement, for the Study entitled “ XXX” MK XXX, site number: XXX (the "Protocol") which is attached as Exhibit A and incorporated into this Agreement by reference. Institution Provider of Medical Services certifies that, to its best knowledge, its facilities and patient population are adequate to perform the Study contemplated by this Agreement and the Protocol. Institution Provider of Medical Services and the Principal Investigator agree that all aspects of the Study will be conducted in conformity with all applicable laws and regulations of the Czech Republic, namely Act No. 378/2007 Coll., on Pharmaceuticals and on amendments to certain related acts (the Act on Pharmaceuticals) (hereinafter: the “Act on Pharmaceuticals”), Act No. 372/2011 Coll., on Health Services and Conditions of their provision, as amended, including implementing legal regulations to these Acts (in particular Decree No. 226/2008 Coll., which determines good clinical practice and detailed conditions for clinical trials of pharmaceuticals), the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Good Clinical Practice: Consolidated Guideline and other generally accepted standards of good clinical practice. 2. Principal Investigator Principal Investigator will be responsible for the direction and supervision of all Study efforts in accordance with the Protocol and this Agreement. Principal Investigator and Institution Provider of Medical Services shall provide all of the services contemplated herein through fully trained and competent Study Staff Collaborative Persons (as defined below) having a skill level appropriate for the tasks assigned to them and shall ensure that all Study Staff Collaborative Persons (as defined below)comply below) comply with the terms of this Agreement and the Protocol. “Study StaffCollaborative Persons” means (i) employees, officers, and directors of InstitutionProvider of Medical Services, including without limitation the Principal Investigator, and (ii) any agents, contractors or other third parties approved by Sponsor in writing in accordance with Article 15. In the event that Principal Investigator leaves or is removed from the Institution, then Institution shall, within ten (10) days of becoming aware of such departure by Principal Investigator, provide written notice of such event to Sponsor. Any successor to Principal Investigator must be Provider Smluvní strany se dohodly následovně: 1.

Scope of Work A. The Institution and Principal Investigator shall perform the Study in accordance with a permission obtained from the State Institute for Drug Control, a concurring opinion of the Ethical Commission, the terms of this Agreement and the andthe final protocol, including as it may be amended in accordance with the terms of this Agreement, for the Study entitled “ XXX” MK “XXX“(the „Study“), protocol number XXX, site number: number XXX (the "Protocol") which is attached as Exhibit A and incorporated into this Agreement by reference. Institution certifies that, to its best knowledge, its facilities and patient population are adequate to perform the Study contemplated by this Agreement and the Protocol. The Study will be performed in the Oncology Clinic of Fakulty Hospital Ostrava. Institution and the Principal Investigator agree that all aspects of the Study will be conducted in conformity with all applicable laws and regulations of the Czech Republic, namely Act No. 378/2007 Coll., on Pharmaceuticals and on amendments to certain related acts (the Act on Pharmaceuticals) (hereinafter: the “Act on Pharmaceuticals”), Act No. 372/2011 Coll., on Health Services and Conditions of their provision, as amended, including implementing legal regulations to these Acts (in particular Decree No. 226/2008 Coll., which determines good clinical practice and detailed conditions for clinical trials of pharmaceuticals), the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Good Clinical Practice: Consolidated Guideline and other generally accepted standards of good clinical practice. 2. Principal Investigator Principal Investigator will be responsible for the direction and supervision of all Study efforts in accordance with the Protocol and this Agreement. Principal Investigator and Institution shall provide all of the services contemplated herein through fully trained and competent Study Staff (as defined below) having a skill level appropriate for the tasks assigned to them and shall ensure that all Study Staff (as defined below)comply with the terms of this Agreement and the Protocol. “Study Staff” means (i) employees, officers, and directors of Institution, including without limitation the Principal Investigator, and (ii) any agents, contractors or other third parties approved by Sponsor in writing in accordance with Article 15. In the event that Principal Investigator leaves or is removed from the Institution, then Institution shall, within ten (10) days of becoming aware of such departure by Principal Investigator, provide written notice of such event to Sponsor. Any successor to Principal Investigator must be Smluvní strany se dohodly následovně: 1.

Scope of Work A. The Institution Provider of Medical Services and Principal Investigator shall perform the Study in accordance with a permission obtained from the State Institute for Drug Control, a concurring opinion of the Ethical Commission, the terms of this Agreement and the final protocol, including as it may be amended in accordance with the terms of this Agreement, for the Study entitled “ XXX” MK XXX, site number: XXX (the "Protocol") which is attached as Exhibit A and incorporated into this Agreement by reference. Institution Provider of Medical Services certifies that, to its best knowledge, its facilities and patient population are adequate to perform the Study contemplated by this Agreement and the Protocol. Institution Provider of Medical Services and the Principal Investigator agree that all aspects of the Study will be conducted in conformity with all applicable laws and regulations of the Czech Republic, namely Act No. 378/2007 Coll., on Pharmaceuticals and on amendments to certain related acts (the Act on Pharmaceuticals) (hereinafter: the “Act on Pharmaceuticals”), Act No. 372/2011 Coll., on Health Services and Conditions of their provision, as amended, including implementing legal regulations to these Acts (in particular Decree No. 226/2008 Coll., which determines good clinical practice and detailed conditions for clinical trials of pharmaceuticals), the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Good Clinical Practice: Consolidated Guideline and other generally accepted standards of good clinical practice. 2. Principal Investigator Principal Investigator will be responsible for the direction and supervision of all Study efforts in accordance with the Protocol and this Agreement. Principal Investigator and Institution Provider of Medical Services shall provide all of the services contemplated herein through fully trained and competent Study Staff Collaborative Persons (as defined below) having a skill level appropriate for the tasks assigned to them and shall ensure that all Study Staff Collaborative Persons (as defined below)comply below) comply with the terms of this Agreement and the Protocol. “Study StaffCollaborative Persons” means (i) employees, officers, and directors of InstitutionProvider of Medical Services, including without limitation the Principal Investigator, and (ii) any agents, contractors or other third parties approved by Sponsor in writing in accordance with Article 15. In the event that Principal Investigator leaves or is removed from the InstitutionProvider of Medical Services, then Institution Provider of Medical Services shall, within ten (10) days of becoming aware of such departure by Principal Investigator, provide written notice of such event to Sponsor. Any successor to Principal Investigator must be Smluvní strany se dohodly následovně: 1.

Scope of Work A. The Institution and Principal Investigator shall perform the Study in accordance with a witha permission obtained from the State Institute for Drug Control, a concurring opinion of the Ethical Commission, the terms of this Agreement and the final protocol, including as it may be amended in accordance with the terms of this Agreement, for the Study entitled “ “XXX” MK ”, Protocol Number: XXX, site number: Site No. XXX (the "Protocol") which is attached as Exhibit A and incorporated into this Agreement by reference. Institution certifies that, to its best knowledge, its facilities and patient population are adequate to perform the Study contemplated by this Agreement and the Protocol. Institution and the Principal Investigator agree that all aspects of the Study will be conducted in conformity with all applicable laws and regulations of the Czech Republic, namely Act No. 378/2007 Coll., on Pharmaceuticals and on amendments to certain related acts (the Act on Pharmaceuticals) (hereinafter: the “Act on Pharmaceuticals”), Act No. 372/2011 Coll., on Health Services services and Conditions of their provision, as amended, including implementing legal regulations to these Acts (in particular Decree No. 226/2008 Coll., which determines good clinical practice and detailed conditions for clinical trials of pharmaceuticals), the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Good Clinical Practice: Consolidated Guideline and other generally accepted standards of good clinical practice. 2. Principal Investigator Principal Investigator will be responsible for the direction and supervision of all Study efforts in accordance with the Protocol and this Agreement. Principal Investigator and Institution shall provide all of the services contemplated herein through fully trained and competent Study Staff (as defined below) having a skill level appropriate for the tasks assigned to them and shall ensure that all Study Staff (as defined below)comply below) comply with the terms of this Agreement and the Protocol. “Study Staff” means (i) employeesvůle, officersjakož i přebírat veškeré písemnosti určené Zadavateli, and directors of Institutionpřičemž Zdravotnické zařízení a Hlavní zkoušející souhlasí s xxx, including without limitation the Principal Investigator, and (ii) any agents, contractors or other third parties approved by Sponsor in writing in accordance with Article 15že veškeré povinnosti vůči Zadavateli vyplývající z této Smlouvy budou plněny vůči Společnosti jako zástupci Zadavatele. In the event that Principal Investigator leaves or is removed from the Institution, then Institution shall, within ten (10) days of becoming aware of such departure by Principal Investigator, provide written notice of such event to Sponsor. Any successor to Principal Investigator must be Smluvní strany se dohodly následovně: 1. R ozsah činnosti A. Zdravotnické zařízení a Hlavní zkoušející provedou Studii v souladu s povolením Státního ústavu pro kontrolu léčiv, souhlasným stanoviskem Etické komise, podmínkami této Smlouvy a konečného znění protokolu, a to včetně případných změn a doplňků učiněných v souladu s touto Smlouvou; pro Studii nazvanou "XXX" XXX, xxxxx centra XXX (xxxx xxx „Protokol“), který tvoří nedílnou součást této Smlouvy jako její Příloha A. Zdravotnické zařízení osvědčuje, že podle jeho nejlepšího vědomí, jsou jeho zařízení a populace pacientů vhodní pro provedení Studie předpokládané touto Smlouvou a Protokolem. Zdravotnické zařízení a Hlavní zkoušející souhlasí, že veškeré aspekty této Studie budou provedeny v souladu se všemi příslušnými právními předpisy České republiky, zejména zákonem č. 378/2007 Sb., o léčivech a o změnách některých souvisejících zákonů (zákon o léčivech) (xxxx xxx „Zákon o léčivech“), zákonem č. 372/2011 Sb., o zdravotních službách a podmínkách jejich poskytování, v platném znění, včetně prováděcích předpisů k těmto zákonům (zejména vyhláškou č. 226/2008 Sb., kterou se stanoví správná klinická praxe a bližší podmínky klinického hodnocení léčiv), Mezinárodní konferencí o harmonizaci technických požadavků na registraci humánních léčivých přípravků Správná klinická praxe: Konsolidovaná směrnice (the International Conference on Harmonisation of Technical Requirements for Registration of

Scope of Work A. The Institution and Principal Investigator shall perform the Study in accordance with a permission obtained from the State Institute for Drug ControlControl issued on. 7th November 2016 ref. number XXX, a concurring opinion of the Multicentric ethical commission issued on 14th November 2016, XXX and Local Ethical CommissionCommission issued on 4th October 2016, ref. number XXX. The permission of the State Institute for Drug Control and the concurring opinions of Multicentric and Local Ethical Commissions are attached as Apendix C to this Agreeement. The study shall also be conducted in compliance with the terms of this Agreement and the final protocol, including as it may be amended in accordance with the terms of this Agreement, for the Study entitled “XXX“ XXX” MK Protocol Number XXX, site number: Site Number XXX (the "Protocol") which is attached as Exhibit A and incorporated into this Agreement by reference. Institution certifies that, to its best knowledge, its facilities and patient population are adequate to perform the Study contemplated by this Agreement and the Protocol. Institution and the Principal Investigator agree that all aspects of the Study will be conducted in conformity with all applicable laws and regulations of the Czech Republic, namely Act No. 378/2007 Coll., on Pharmaceuticals and on amendments to certain related acts (the Act on Pharmaceuticals) (hereinafter: the “Act on Pharmaceuticals”), Act No. Act No. 372/2011 Coll., on Health Services and Conditions of their provision, as amended, including implementing legal regulations to these Acts (in particular Decree Regulation No. 226/2008 Coll., which determines good clinical practice and detailed conditions for clinical trials of pharmaceuticals, as amended), the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Good Clinical Practice: Consolidated Guideline and other generally accepted standards of good clinical practice. 2. Principal Investigator Principal Investigator will be responsible for the direction and supervision of all Study efforts in accordance with the Protocol and this Agreement. Principal Investigator and Institution shall provide all of the services contemplated herein through fully trained and competent Study Staff (as defined below) having a skill level appropriate for the tasks assigned to them and shall ensure that all Study Staff (as defined below)comply with the terms of this Agreement and the ProtocolSpolečnosti jako zástupci Zadavatele. “Study Staff” means (i) employees, officers, and directors of Institution, including without limitation the Principal Investigator, and (ii) any agents, contractors or other third parties approved by Sponsor in writing in accordance with Article 15. In the event that Principal Investigator leaves or is removed from the Institution, then Institution shall, within ten (10) days of becoming aware of such departure by Principal Investigator, provide written notice of such event to Sponsor. Any successor to Principal Investigator must be Smluvní strany se dohodly následovně: 1.

Scope of Work A. The Institution and Principal Investigator shall perform the Study in accordance with a witha permission obtained from the State Institute for Drug Control, a concurring opinion of the Ethical Commission, the terms of this Agreement and the final protocol, including as it may be amended in accordance with the terms of this Agreement, for the Study entitled “ XXX” MK XXX, site number: XXX (the "Protocol") which is attached as Exhibit A and incorporated into this Agreement by reference. Institution certifies that, to its best knowledge, its facilities and patient population are adequate to perform the Study contemplated by this Agreement and the Protocol. Institution and the Principal Investigator agree that all aspects of the Study will be conducted in conformity with all applicable laws and regulations of the Czech Republic, namely Act No. 378/2007 Coll., on Pharmaceuticals and on amendments to certain related acts (the Act on Pharmaceuticals) (hereinafter: the “Act on Pharmaceuticals”), Act No. 372/2011 Coll., on Health Services and Conditions of their provision, as amended, , including implementing legal regulations to these Acts (in particular Decree No. 226/2008 Coll., which determines good clinical practice and detailed conditions for clinical trials of pharmaceuticals), the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Good Clinical Practice: Consolidated Guideline and other generally accepted standards of good clinical practice. 2. Principal Investigator Principal Investigator will be responsible for the direction and supervision of all Study efforts in accordance with the Protocol and this Agreement. Principal Investigator and Institution shall provide all of the services contemplated herein through fully trained and competent Study Staff (as defined below) having a skill level appropriate for the tasks assigned to them and shall ensure that all Study Staff (as defined below)comply below) comply with the terms of this Agreement and the Protocoltéto Smlouvy, veškeré právní a jiné úkony, které jsou nutné, účelné nebo vhodné v souvislosti s plněním práv a povinností Zadavatele této Studie. “Study Staff” means (i) employeesSpolečnost tak jménem Zadavatele bude zejména činit veškeré ústní nebo písemné projevy vůle, officersjakož i přebírat veškeré písemnosti určené Zadavateli, and directors of Institutionpřičemž Zdravotnické zařízení a Hlavní zkoušející souhlasí s xxx, including without limitation the Principal Investigator, and (ii) any agents, contractors or other third parties approved by Sponsor in writing in accordance with Article 15že veškeré povinnosti vůči Zadavateli vyplývající z této Smlouvy budou plněny vůči Společnosti jako zástupci Zadavatele. In the event that Principal Investigator leaves or is removed from the Institution, then Institution shall, within ten (10) days of becoming aware of such departure by Principal Investigator, provide written notice of such event to Sponsor. Any successor to Principal Investigator must be Smluvní strany se dohodly následovně: 1.

Scope of Work A. The Institution and Principal Investigator shall perform the Study in accordance with a permission obtained from the State Institute for Drug ControlControl issued on ref. number XXX, a concurring opinion of the Multicentric ethical commission issued on , ref. number XXX and Local Ethical CommissionCommission issued on , ref. number XXX. The permission of the State Institute for Drug Control and the concurring opinions of Multicentric and Local Ethical Commissions are attached as Apendix C to this Agreeement. The study shall also be conducted in compliance with the terms of this Agreement and the final protocol, including as it may be amended in accordance with the terms of this Agreement, for the Study entitled “ “XXX” MK ”. Protocol Number XXX, site number: Site Number XXX (the "Protocol") which is attached as Exhibit A and incorporated into this Agreement by reference. Institution certifies that, to its best knowledge, its facilities and patient population are adequate to perform the Study contemplated by this Agreement and the Protocol. Institution and the Principal Investigator agree that all aspects of the Study will be conducted in conformity with all applicable laws and regulations of the Czech Republic, namely Act No. 378/2007 Coll., on Pharmaceuticals and on amendments to certain related acts (the Act on Pharmaceuticals) (hereinafter: the “Act on Pharmaceuticals”), Act No. Act No. 372/2011 Coll., on Health Services and Conditions of their provision, as amended, including implementing legal regulations to these Acts (in particular Decree Regulation No. 226/2008 Coll., which determines good clinical practice and detailed conditions for clinical trials of pharmaceuticals, as amended), the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Good Clinical Practice: Consolidated Guideline and other generally accepted standards of good clinical practice. 2. Principal Investigator Principal Investigator will be responsible for the direction and supervision of all Study efforts in accordance with the Protocol and this Agreement. Principal Investigator and Institution shall provide all of the services contemplated herein through fully trained and competent Study Staff (as defined below) having a skill level appropriate for the tasks assigned to them and shall ensure that all Study Staff (as defined below)comply with the terms of this Agreement and the ProtocolZadavateli vyplývající z této Smlouvy budou plněny vůči Společnosti jako zástupci Zadavatele. “Study Staff” means (i) employees, officers, and directors of Institution, including without limitation the Principal Investigator, and (ii) any agents, contractors or other third parties approved by Sponsor in writing in accordance with Article 15. In the event that Principal Investigator leaves or is removed from the Institution, then Institution shall, within ten (10) days of becoming aware of such departure by Principal Investigator, provide written notice of such event to Sponsor. Any successor to Principal Investigator must be Smluvní strany se dohodly následovně: 1.