Common use of Zveřejnění Clause in Contracts

Zveřejnění. Strany souhlasí, že v případě, že Xxxxxxx bude muset být zveřejněna podle zákona č. 340/2015 Sb., o zvláštních podmínkách účinnosti některých smluv, uveřejňování těchto smluv a o registru smluv („zákon o registru smluv“) nebo podle dalších souvisejících regulačních opatření, provedou následující:  Zdravotnické zařízení zveřejní Xxxxxxx s ohledem na postup uvedený v tomto odstavci;  Důvěrné informace specifické pro klinické hodnocení a další důvěrné informace podle Článku 2 této Smlouvy nebudou zveřejněny;  Pro účely zveřejnění poskytne Zdravotnické zařízení Správci registru smluv kopii podepsané smlouvy ve formátu, který vyžaduje Zákon o registru smluv;  Zdravotnické zařízení bude informovat společnosti Quintiles o provedeném zveřejnění Smlouvy: (i) v registru smluv, je-li to možné, Zdravotnické zařízení uvede emailovou adresu společnosti Quintiles pro účel poskytnutí potvrzení ohledně zveřejnění Smlouvy; (ii) v případě, že možnost (i) výše nelze provést, Zdravotnické zařízení poskytne během 5 pracovních dnů od přijetí potvrzení o zveřejnění Smlouvy takové informace a příslušné důkazy společnosti Quintiles. Pro účely tohoto odstavce bude použita následující emailová adresa společnosti Quintiles: XXXXXXXXXXXXXXXXXXXXXXXXXXXX  Zdravotnické zařízení zveřejní Smlouva a rovněž poskytne potvrzení o zveřejnění společnosti Quintiles, jak je uvedeno výše v tomto odstavci během 2 měsíců od podpisu Smlouvy;  V případě, že Smlouva bude zveřejněna jako porušení Zákona o registru smluv a/nebo této Smlouvy, Zdravotnické zařízení okamžitě, ale ne později než 2 dny od okamžiku, kdy se dozví o takovém porušení nebo od přijetí písemného požadavku od společnosti Quintiles odstraní porušení a zajistí, že zveřejnění je v souladu se Zákonem o registru smluv a rovněž s touto Smlouvou;  V případě jakýchkoli dodatků zveřejněných informací informuje Zdravotnické zařízení o takových dodatcích okamžitě, ale ne později než během 2 pracovních dnů společnost Quintiles. Bez omezení uplatňování pravidel uvedených v tomto článku výše musí Zdravotnické zařízení v každém případě zveřejnit Smlouvu s ohledem na požadavky stanovené Zákonem o registru smluv, jakož i jakýchkoli jiných platných zákonů. Zdravotnické zařízení odškodní a zajistí ochranu společnosti Quintiles proti jakýmkoli případným škodám vzniklým z porušení Zákona o registru smluv nebo jiných platných zákonů ze strany Zdravotnického zařízení. 4.1. Řádné plnění tohoto odstavce je považováno za podstatně významné pro účely této Smlouvy; porušení jakýchkoliv povinností stanovených v tomto oddíle bude považováno za závažné porušení Smlouvy a kterákoli strana, která utrpí újmu takovým porušením má nárok na náhradu škod. 4.2. V případě jakýchkoli dodatků Zákona o registru smluv a/nebo souvisejících zákonných požadavků Strany souhlasí, že příslušným způsobem upraví tuto Smlouvu, bude-li třeba. 3) Ownership and Intellectual Property Rights Proprietary Information: All documents, data, know-how, formulas, protein and DNA sequences, and the Investigational Product, comparator, placebo provided to the Institution or Investigator for purposes of the Study are and shall remain the property of Sponsor and will be returned to Sponsor, Quintiles, or their respective designees upon request. Rights to Results: All data, information and materials developed or generated by Institution or Investigator as a result, or arising out, of the Study (“Study Results”) shall be the sole and exclusive property of Sponsor. Sponsor may use Study Results in connection with any of its research, development, marketing or promotional activities and in any other manner deemed appropriate to Sponsor's business interests. The Institution assigns all rights of Study Results obtained in the Study to Sponsor. Investigator shall notify Quintiles or Sponsor of the Study Results promptly, separately and in writing. Intellectual Property: (a) As used herein, “Intellectual Property” shall mean all rights, title and interest in and to the intellectual property and materials that are the subject of the Study or the Protocol, including, without limitation, all property rights in the Investigational Product and all data, technical information, inventions, discoveries, developments, improvements, enhancements, software, know-how, methods, techniques, formulae, data, processes and other proprietary ideas (whether or not patentable or registrable under patent, copyright or similar laws) and materials related to any product (including, without limitation, the Investigational Product), the Study or the Protocol, or otherwise derived, conceived, discovered, developed or reduced to practice as a direct or indirect result of the Institution’s performance of any services under or pursuant to this Agreement or during the course of or in connection with the Study whether generated or developed by the Institution, Quintiles or Sponsor or their respective agents, employees or contractors, either solely or jointly with others. Institution and Investigator acknowledge that all Intellectual Property shall be considered Confidential Information subject to Section 2. (b) All Intellectual Property shall be the sole and exclusive property of Sponsor. The Institution, including its employees or agents, shall not acquire any Intellectual Property or any other rights of any kind whatsoever with respect to the Investigational Product as a result of performance under this Agreement. The Institution hereby agrees to assign and herewith assigns to Sponsor all Intellectual Property and other rights resulting from the Study and the work under this Agreement. At all times, Sponsor shall have the exclusive right to use, assign, license or transfer ownership of any Intellectual Property without payment of any compensation to the Institution for such Intellectual Property. (c) The Institution agrees to promptly notify Sponsor of any such Intellectual Property invention, discovery or improvement, and to make all statements legally necessary to vest title in such invention, discovery or improvement in Sponsor. Sponsor shall have the sole and exclusive right to obtain, file and prosecute in its own name and at its expense, applications for patents on any information derived from Intellectual Property. Upon request and at the expense of Sponsor, the Institution shall assist Sponsor in securing and enforcing Sponsor’s rights in the Intellectual Property, including disclosure to Sponsor of all relevant or pertinent information and data with respect to such Intellectual Property and the execution of all oaths, assignments and other instruments necessary in order to apply for and obtain such rights and in order to assign and convey to Sponsor, its successors and assigns the sole and exclusive rights, title and interest in and to such Intellectual Property and any copyrights, patents or other intellectual property rights relating thereto. (d) Institution and Investigator warrant by the execution of this Agreement that they have not entered, and will not enter, into any contractual agreement or relationship which would in any way conflict with or compromise Sponsor’s rights to, any Study Results, inventions, discoveries, or technology arising out of or related to their performance thereunder. 4) Publicity and Publication. Sponsor shall have unrestricted publication rights for the Study Results and may give the data to third parties for publication. Quintiles and Sponsor recognize and acknowledge Institution’s interest in making publications relating to the Study in journals, at meetings or otherwise, for non-commercial purposes. Upon completion of the Study but not before the first publication of the consolidated Study results, or when data are adequate (in Sponsor’s reasonable judgement), the Institution has the right to prepare the data for publication. At least sixty (60) days prior to submitting or presenting a manuscript or other materials relating to the Study to a publisher, reviewer, or other outside persons, the Institution shall provide to Sponsor a copy of all such manuscripts and materials, and allow Sponsor sixty (60) days to review and comment on them. Unless Sponsor informs, the Institution and/or Investigator in writing during this sixty (60) day period that the proposed publication must be delayed in order to protect a patentable invention or changed a) to avoid disclosure of Confidential Information trade secrets or know-how, b) to ensure the accuracy of the presentation or publication, or c) to enable relevant supplementary information to be provided, Institution shall be free to publish the Study results Study results/data subject to the publication rules of this Section 4. In the event that a delay of the proposed publication is required, Institution shall withhold such submission for publication for an additional period agreed upon in good faith by the parties, however no longer than eighteen (18) months after submission of a respective patent application by Sponsor. The Institution agrees that if the Study is part of a multi-center study, any publication by the Institution of the results of the Study conducted at the Site shall not be made before the first multi-center publication; provided, however, that if no multi-center publication is made within one year from database lock, then the Institution may publish individually in accordance with this provision. For all publications relating to the Study or including any Study data, Sponsor, Site and Investigator agree to comply with the Good Publication Practise Guidelines (found at: xxxx://xxx.xxxxx.xxx) and all ethical standards concerning publications and authorship, including the rules of Good Scientific Practice, the guidelines for publications of clinical Study data as outlined e.g. by editors of the major medical journals as well as all ethical standards concerning publications and authorship, including the “Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals” as established by the International Committee of Medical Journal Editors (“ICMJE”) (found at xxxx://xxx.xxxxx.xxx). Authorship of any publications relating to the Study shall be determined by mutual agreement. Sponsor has the right to name co-authors. A representative of the Sponsor substantially involved in the implementation of the Study will serve as co-author in the primary full publication of the study, unless otherwise agreed. Institution shall oblige all its employees and other third parties participating in the conduct of the Study to comply with the above mentioned obligations. No party hereto shall use any other party’s name, or Sponsor’s name trademarks, logos, physical likeness, employee name, owner symbol, or other image, in connection with any advertising, publication or promotion as well as in any other publications, applications or forms without prior written permission, except that the Sponsor and Quintiles may use the Institution’s and Investigator’s name in Study publications and communications, including clinical trial websites and Study newsletters, and as stated in Section 4 of the Agreement. Furthermore, Sponsor, may use the name of Institution and/or Investigator in any publication, applications or forms, or other materials submitted to any regulatory authority and/or other disclosures required by Applicable Law such as disclosures in clinical trial registries. Designation of Business Secret. Parties hereby acknowledge and agree that Attachment B, the minimum enrollment goal, expected number of Study subjects enrolled and the expected duration of the Study, Investigator’s Brochure, Insurance Contract on Clinical Trial Insurance, Clinical Trial Protocol and personal data of the individuals, (further stated as „Trial Specific Confidential Information“), are deemed as information significant within the meaning of statutory definition of business secret (Section 504 of Act No. 89/2012 Coll., the Civil Code), as universal access to such information may have a substantial impact on economic results and market position of the Sponsor and members of the Sponsor’s group in other EU Member States. Trial Specific Confidential Information are either part of the text of the main Agreement or individual attachments to this Agreement. Institution and Investigator acknowledge that they also deem Trial Specific Confidential Information significant within the meaning of statutory definition of business secret (Section 504 of Act No. 89/2012 Coll., the Civil Code) and undertake to keep such information confidential in accordance with Section 2) hereof. Disclosure. The Parties hereby agree that in case Agreement must be disclosed pursuant to Act. No. 340/2015 Coll. on Special Conditions of Effectiveness of Certain Contracts, Publication thereof and the Contracts Register („Contract Registry Act“) or pursuant to other related legal regulations, they shall act as following:  Institution shall disclose Agreement with respect to procedure indicated in this clause;  Trial Specific Confidential Information and other confidential information according to the Article 2 of this Agreement shall not be disclosed;  For the purposes of disclosure, Institution shall provide to the Administrator of the Contract’s Register a copy of the signed Agreement in a format required by the Contract Registry Act;  Institution shall inform Quintiles of the performed disclosure of the Agreement: (i) in the Contract Register, if possible, Institution shall include Quintiles’ email address for the purpose of provision of the confirmation about the disclosure of the Agreement; (ii) in case option (i) above could not be implemented, Institution shall within 5 business days as of receipt of the confirmation on the disclosure of the Agreement provide such information and the respective evidence to the Quintiles. For the purposes of this clause following email address of Quintiles shall be used: XXXXXXXXXXXXXXXXXXXXXXXXXXXX  Institution shall disclose Agreement as well as provide confirmation about the disclosure to Quintiles as indicated above in this clause within 2 months as of signing of the Agreement;  In case the Agreement will be disclosed in breach with the Contract Registry Act and / or this Agreement, the Institution shall immediately but not later than within 2 days as of becoming aware of such breach or as of receipt of the written request from the Quintiles eliminate the breach and ensure that the disclosure meets Contract Registry Act as well as this Agreement;  In case any amendments would be performed to the disclosed information, Institution shall immediately but not later than within 2 business days inform Quintiles of such amendments. Without limiting application of the rules indicated in this clause above, Institution shall at all events disclose Agreement with respect to requirements established by the Contract Registry Act as well as any other applicable laws. Institution shall indemnify and hold Quintiles harmless for any damage resulting of a breach of the Contract Registry Act or other applicable laws by the Institution. 4.1. Proper performance of this clause is considered of significant importance for the purposes of this Agreement; breach of any obligations stipulated in this section will be considered as serious breach of the Agreement and any Party suffering by such breach shall be entitled to claim the incurred damages. 4.2. In case of any amendments to the Contract Registry Act and / or related legal requirements, Parties agree to amend this Agreement respectively, if needed.

Zveřejnění. Strany souhlasí, že v případě, že Xxxxxxx bude muset být zveřejněna podle zákona č. 340/2015 Sb., . o zvláštních podmínkách účinnosti některých smluv, uveřejňování těchto smluv a o registru smluv („zákon o registru smluv“) nebo podle dalších souvisejících regulačních opatření, provedou následující:  Zdravotnické zařízení zveřejní Xxxxxxx Smlouvu s ohledem na postup uvedený v tomto odstavci;  Důvěrné informace specifické pro klinické hodnocení a další důvěrné informace podle Článku 2 Přílohy A této Smlouvy nebudou zveřejněny;  Pro účely zveřejnění poskytne Zdravotnické zařízení Správci registru smluv kopii podepsané smlouvy ve formátu, který vyžaduje Zákon o registru smluv;  Zdravotnické zařízení bude informovat společnosti společnost Quintiles o provedeném zveřejnění Smlouvy: (i) v registru smluv, je-li to možné, Zdravotnické zařízení uvede emailovou adresu společnosti Quintiles pro účel poskytnutí potvrzení ohledně zveřejnění Smlouvy; (ii) v případě, že možnost (i) výše nelze provést, Zdravotnické zařízení poskytne během 5 10 pracovních dnů od přijetí potvrzení o zveřejnění Smlouvy takové informace a příslušné důkazy společnosti Quintiles. Pro účely tohoto odstavce bude použita následující emailová adresa společnosti Quintiles: XXXXXXXXXXXXXXXXXXXXXXXXXXXX XXXXXXXXXXXXXXX  Zdravotnické zařízení zveřejní Smlouva Smlouvu a rovněž poskytne potvrzení o zveřejnění společnosti Quintiles, jak je uvedeno výše v tomto odstavci během 2 měsíců 10 pracovních dnů od podpisu Smlouvy;  V případě, že Smlouva bude zveřejněna jako porušení Zákona o registru smluv a/nebo této Smlouvy, Zdravotnické zařízení okamžitě, ale ne později než 2 dny od okamžiku, kdy se dozví o takovém porušení nebo od přijetí písemného požadavku od společnosti Quintiles odstraní porušení a zajistí, že zveřejnění je v souladu se Zákonem o registru smluv a rovněž s touto Smlouvou;  V případě jakýchkoli dodatků zveřejněných informací informuje Zdravotnické zařízení o takových dodatcích okamžitě, ale ne později než během 2 pracovních dnů společnost Quintiles. Bez omezení uplatňování pravidel uvedených v tomto článku výše musí Zdravotnické zařízení v každém případě zveřejnit Smlouvu s ohledem na požadavky stanovené Zákonem o registru smluv, jakož i jakýchkoli jiných platných zákonů. Zdravotnické zařízení odškodní a zajistí ochranu společnosti Quintiles proti jakýmkoli případným škodám vzniklým z porušení Zákona o registru smluv nebo jiných platných zákonů ze strany Zdravotnického zařízení. 4.1. Řádné plnění tohoto odstavce je považováno za podstatně významné pro účely této Smlouvy; porušení jakýchkoliv povinností stanovených v tomto oddíle bude považováno za závažné porušení Smlouvy a kterákoli strana, která utrpí újmu takovým porušením má nárok na náhradu škod. 4.2. V případě jakýchkoli dodatků Zákona o registru smluv a/nebo souvisejících zákonných požadavků Strany souhlasí, že příslušným způsobem upraví tuto Smlouvu, bude-li třeba. 3) Ownership and Intellectual Property Rights Proprietary Information: All documents, data, know-how, formulas, protein and DNA sequences, and the Investigational Product, comparator, placebo provided to the Institution or Investigator for purposes of the Study are and shall remain the property of Sponsor and will be returned to Sponsor, Quintiles, or their respective designees upon request. Rights to Results: All data, information and materials developed or generated by Institution or Investigator as a result, or arising out, of the Study (“Study Results”) shall be the sole and exclusive property of Sponsor. Sponsor may use Study Results in connection with any of its research, development, marketing or promotional activities and in any other manner deemed appropriate to Sponsor's business interests. The Institution assigns all rights of Study Results obtained in the Study to Sponsor. Investigator shall notify Quintiles or Sponsor of the Study Results promptly, separately and in writing. Intellectual Property: (a) As used herein, “Intellectual Property” shall mean all rights, title and interest in and to the intellectual property and materials that are the subject of the Study or the Protocol, including, without limitation, all property rights in the Investigational Product and all data, technical information, inventions, discoveries, developments, improvements, enhancements, software, know-how, methods, techniques, formulae, data, processes and other proprietary ideas (whether or not patentable or registrable under patent, copyright or similar laws) and materials related to any product (including, without limitation, the Investigational Product), the Study or the Protocol, or otherwise derived, conceived, discovered, developed or reduced to practice as a direct or indirect result of the Institution’s performance of any services under or pursuant to this Agreement or during the course of or in connection with the Study whether generated or developed by the Institution, Quintiles or Sponsor or their respective agents, employees or contractors, either solely or jointly with others. Institution and Investigator acknowledge that all Intellectual Property shall be considered Confidential Information subject to Section 2. (b) All Intellectual Property shall be the sole and exclusive property of Sponsor. The Institution, including its employees or agents, shall not acquire any Intellectual Property or any other rights of any kind whatsoever with respect to the Investigational Product as a result of performance under this Agreement. The Institution hereby agrees to assign and herewith assigns to Sponsor all Intellectual Property and other rights resulting from the Study and the work under this Agreement. At all times, Sponsor shall have the exclusive right to use, assign, license or transfer ownership of any Intellectual Property without payment of any compensation to the Institution for such Intellectual Property. (c) The Institution agrees to promptly notify Sponsor of any such Intellectual Property invention, discovery or improvement, and to make all statements legally necessary to vest title in such invention, discovery or improvement in Sponsor. Sponsor shall have the sole and exclusive right to obtain, file and prosecute in its own name and at its expense, applications for patents on any information derived from Intellectual Property. Upon request and at the expense of Sponsor, the Institution shall assist Sponsor in securing and enforcing Sponsor’s rights in the Intellectual Property, including disclosure to Sponsor of all relevant or pertinent information and data with respect to such Intellectual Property and the execution of all oaths, assignments and other instruments necessary in order to apply for and obtain such rights and in order to assign and convey to Sponsor, its successors and assigns the sole and exclusive rights, title and interest in and to such Intellectual Property and any copyrights, patents or other intellectual property rights relating thereto. (d) Institution and Investigator warrant by the execution of this Agreement that they have not entered, and will not enter, into any contractual agreement or relationship which would in any way conflict with or compromise Sponsor’s rights to, any Study Results, inventions, discoveries, or technology arising out of or related to their performance thereunder. 4) Publicity and Publication. Sponsor shall have unrestricted publication rights for the Study Results and may give the data to third parties for publication. Quintiles and Sponsor recognize and acknowledge InstitutionSite’s interest in making publications relating to the Study in journals, at meetings or otherwise, for non-commercial purposes. Upon completion of the Study but not before the first publication of the consolidated Study results, or when data are adequate (in Sponsor’s reasonable judgement), the Institution Site has the right to prepare the data for publication. At least sixty (60) days prior to submitting or presenting a manuscript or other materials relating to the Study to a publisher, reviewer, or other outside persons, the Institution Site shall provide to Sponsor a copy of all such manuscripts and materials, and allow Sponsor sixty (60) days to review and comment on them. Unless Sponsor informs, informs the Institution and/or Investigator Site in writing during this sixty (60) day period that the proposed publication must be delayed in order to protect a patentable invention or changed a) to avoid disclosure of Confidential Information Information, trade secrets or know-how, b) to ensure the accuracy of the presentation or publication, or c) to enable relevant supplementary information to be provided, Institution Site shall be free to publish the Study results Study results/data subject to the publication rules of this Section 4. In the event that a delay of the proposed publication is required, Institution Site shall withhold such submission for publication for an additional period agreed upon in good faith by the parties, however no longer than eighteen (18) months after submission of a respective patent application by Sponsor. The Institution Site agrees that if the Study is part of a multi-center study, any publication by the Institution Site of the results of the Study conducted at the Site shall not be made before the first multi-center publication; provided, however, that if no multi-center publication is made within one year from database lock, then the Institution Site may publish individually in accordance with this provision. For all publications relating to the Study or including any Study data, Sponsor, Site and Investigator agree to comply with the Good Publication Practise Guidelines (found at: xxxx://xxx.xxxxx.xxx) and all ethical standards concerning publications and authorship, including the rules of Good Scientific Practice, the guidelines for publications of clinical Study data as outlined e.g. by editors of the major medical journals as well as all ethical standards concerning publications and authorship, including the “Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals” as established by the International Committee of Medical Journal Editors (“ICMJE”) (found at xxxx://xxx.xxxxx.xxx). Authorship of any publications relating to the Study shall be determined by mutual agreement. Sponsor has the right to name co-authors. A representative of the Sponsor substantially involved in the implementation of the Study will serve as co-author in the primary full publication of the study, unless otherwise agreed. Institution Site shall oblige all its employees and other third parties participating in the conduct of the Study to comply with the above mentioned obligations. No party hereto shall use any other party’s name, or Sponsor’s name name, trademarks, logos, physical likeness, employee name, owner symbol, or other image, image in connection with any advertising, publication or promotion as well as in any other publications, applications or forms forms, without prior written permission, except that the Sponsor and Quintiles may use the Institution’s and InvestigatorSite’s name in Study publications and communications, including clinical trial websites and Study newsletters, and as stated in Section 4 of the Agreement. Furthermore, Sponsor, may use the name of Institution and/or Investigator in any publication, applications or forms, or other materials submitted to any regulatory authority and/or other disclosures required by Applicable Law such as disclosures in clinical trial registries. Designation of Business Secret. Parties hereby acknowledge and agree that Attachment B, the minimum enrollment goal, expected number of Study subjects enrolled and the expected duration of the Study, Investigator’s Brochure, Insurance Contract on Clinical Trial Insurance, Clinical Trial Protocol and personal data of the individuals, (further stated as „Trial Specific Confidential Information“), are deemed as information significant within the meaning of statutory definition of business secret (Section 504 of Act No. 89/2012 Coll., the Civil Code), as universal access to such information may have a substantial impact on economic results and market position of the Sponsor and members of the Sponsor’s group in other EU Member States. Trial Specific Confidential Information are either part of the text of the main Agreement or individual attachments to this Agreement. Institution and Investigator acknowledge that they also deem Trial Specific Confidential Information significant within the meaning of statutory definition of business secret (Section 504 of Act No. 89/2012 Coll., the Civil Code) and undertake to keep such information confidential in accordance with Section 2) hereof. Disclosure. The Parties hereby agree that in case Agreement must be disclosed pursuant to Act. No. 340/2015 Coll. on Special Conditions of Effectiveness of Certain Contracts, Publication thereof and the Contracts Register („Contract Registry Act“) or pursuant to other related legal regulations, they shall act as following:  Institution shall disclose Agreement with respect to procedure indicated in this clause;  Trial Specific Confidential Information and other confidential information according to the Article 2 of the Attachment A of this Agreement shall not be disclosed;  For the purposes of disclosure, Institution shall provide to the Administrator of the Contract’s Register a copy of the signed Agreement in a format required by the Contract Registry Act;  Institution shall inform Quintiles of the performed disclosure of the Agreement: (i) in the Contract Register, if possible, Institution shall include Quintiles’ email address for the purpose of provision of the confirmation about the disclosure of the Agreement; (ii) in case option (i) above could not be implemented, Institution shall within 5 10 business days as of receipt of the confirmation on the disclosure of the Agreement provide such information and the respective evidence to the Quintiles. For the purposes of this clause following email address of Quintiles shall be used: XXXXXXXXXXXXXXXXXXXXXXXXXXXX XXXXXXXXXXXXXXX  Institution shall disclose Agreement as well as provide confirmation about the disclosure to Quintiles as indicated above in this clause within 2 months 10 business days as of signing of the Agreement;  In case the Agreement will be disclosed in breach with the Contract Registry Act and / or this Agreement, the Institution shall immediately but not later than within 2 days as of becoming aware of such breach or as of receipt of the written request from the Quintiles eliminate the breach and ensure that the disclosure meets Contract Registry Act as well as this Agreement;  In case any amendments would be performed to the disclosed information, Institution shall immediately but not later than within 2 business days inform Quintiles Xxxxxxxxx of such amendments. Without limiting application of the rules indicated in this clause above, Institution shall at all events disclose Agreement with respect to requirements established by the Contract Registry Act as well as any other applicable laws. Institution shall indemnify and hold Quintiles harmless for any damage resulting of a breach of the Contract Registry Act or other applicable laws by the Institution. 4.1. Proper performance of this clause is considered of significant importance for the purposes of this Agreement; breach of any obligations stipulated in this section will be considered as serious breach of the Agreement and any Party suffering by such breach shall be entitled to claim the incurred damages. 4.2. In case of any amendments to the Contract Registry Act and / or related legal requirements, Parties agree to amend this Agreement respectively, if needed.

Zveřejnění. Strany souhlasí, že v případě, že Xxxxxxx bude muset být zveřejněna podle zákona č. 340/2015 Sb., . o zvláštních podmínkách účinnosti některých smluv, uveřejňování těchto smluv a o registru smluv („zákon o registru smluv“) nebo podle dalších souvisejících regulačních opatření, provedou následující:  • Zdravotnické zařízení zveřejní Xxxxxxx s ohledem na postup uvedený v tomto odstavci;  • Důvěrné informace specifické pro klinické hodnocení a další důvěrné informace podle Článku 2 Přílohy A této Smlouvy nebudou zveřejněny;  • Pro účely zveřejnění poskytne Zdravotnické zařízení Správci registru smluv kopii podepsané smlouvy ve formátu, který vyžaduje Zákon o registru smluv;  • Zdravotnické zařízení bude informovat společnosti společnost Quintiles o provedeném zveřejnění Smlouvy: (i) v registru smluv, je-li to možné, Zdravotnické zařízení uvede emailovou adresu společnosti Quintiles pro účel poskytnutí potvrzení ohledně zveřejnění Smlouvy; (ii) v případě, že možnost (i) výše nelze provést, Zdravotnické zařízení poskytne během 5 10 pracovních dnů od přijetí potvrzení o zveřejnění Smlouvy Xxxxxxx takové informace a příslušné důkazy společnosti Quintiles. Pro účely tohoto odstavce bude použita následující emailová adresa společnosti Quintiles: XXXXXXXXXXXXXXXXXXXXXXXXXXXX  XXXXXXXXXXXXXXXXX • Zdravotnické zařízení zveřejní Smlouva Smlouvu a rovněž poskytne potvrzení o zveřejnění společnosti Quintiles, jak je uvedeno výše v tomto odstavci během 2 měsíců 10 pracovních dnů od podpisu Smlouvy;  • V případě, že Smlouva Xxxxxxx bude zveřejněna jako porušení Zákona o registru smluv a/nebo této Smlouvy, Zdravotnické zařízení okamžitě, ale ne později než 2 dny od okamžiku, kdy se dozví o takovém porušení nebo od přijetí písemného požadavku od společnosti Quintiles odstraní porušení a zajistí, že zveřejnění je v souladu se Zákonem o registru smluv a rovněž s touto Smlouvou;  V případě jakýchkoli dodatků zveřejněných informací informuje Zdravotnické zařízení o takových dodatcích okamžitě, ale ne později než během 2 pracovních dnů společnost Quintiles. Bez omezení uplatňování pravidel uvedených v tomto článku výše musí Zdravotnické zařízení v každém případě zveřejnit Smlouvu s ohledem na požadavky stanovené Zákonem o registru smluv, jakož i jakýchkoli jiných platných zákonů. Zdravotnické zařízení odškodní a zajistí ochranu společnosti Quintiles proti jakýmkoli případným škodám vzniklým z porušení Zákona o registru smluv nebo jiných platných zákonů ze strany Zdravotnického zařízení. 4.1. Řádné plnění tohoto odstavce je považováno za podstatně významné pro účely této Smlouvy; porušení jakýchkoliv povinností stanovených v tomto oddíle bude považováno za závažné porušení Smlouvy a kterákoli strana, která utrpí újmu takovým porušením má nárok na náhradu škod. 4.2. V případě jakýchkoli dodatků Zákona o registru smluv a/nebo souvisejících zákonných požadavků Strany souhlasí, že příslušným způsobem upraví tuto Smlouvu, bude-li třeba. 3) Ownership and Intellectual Property Rights Proprietary Information: All documents, data, know-how, formulas, protein and DNA sequences, and the Investigational Product, comparator, placebo provided to the Institution or Investigator for purposes of the Study are and shall remain the property of Sponsor and will be returned to Sponsor, Quintiles, or their respective designees upon request. Rights to Results: All data, information and materials developed or generated by Institution or Investigator as a result, or arising out, of the Study (“Study Results”) shall be the sole and exclusive property of Sponsor. Sponsor may use Study Results in connection with any of its research, development, marketing or promotional activities and in any other manner deemed appropriate to Sponsor's business interests. The Institution assigns all rights of Study Results obtained in the Study to Sponsor. Investigator shall notify Quintiles or Sponsor of the Study Results promptly, separately and in writing. Intellectual Property: (a) As used herein, “Intellectual Property” shall mean all rights, title and interest in and to the intellectual property and materials that are the subject of the Study or the Protocol, including, without limitation, all property rights in the Investigational Product and all data, technical information, inventions, discoveries, developments, improvements, enhancements, software, know-how, methods, techniques, formulae, data, processes and other proprietary ideas (whether or not patentable or registrable under patent, copyright or similar laws) and materials related to any product (including, without limitation, the Investigational Product), the Study or the Protocol, or otherwise derived, conceived, discovered, developed or reduced to practice as a direct or indirect result of the Institution’s performance of any services under or pursuant to this Agreement or during the course of or in connection with the Study whether generated or developed by the Institution, Quintiles or Sponsor or their respective agents, employees or contractors, either solely or jointly with others. Institution and Investigator acknowledge that all Intellectual Property shall be considered Confidential Information subject to Section 2. (b) All Intellectual Property shall be the sole and exclusive property of Sponsor. The Institution, including its employees or agents, shall not acquire any Intellectual Property or any other rights of any kind whatsoever with respect to the Investigational Product as a result of performance under this Agreement. The Institution hereby agrees to assign and herewith assigns to Sponsor all Intellectual Property and other rights resulting from the Study and the work under this Agreement. At all times, Sponsor shall have the exclusive right to use, assign, license or transfer ownership of any Intellectual Property without payment of any compensation to the Institution for such Intellectual Property. (c) The Institution agrees to promptly notify Sponsor of any such Intellectual Property invention, discovery or improvement, and to make all statements legally necessary to vest title in such invention, discovery or improvement in Sponsor. Sponsor shall have the sole and exclusive right to obtain, file and prosecute in its own name and at its expense, applications for patents on any information derived from Intellectual Property. Upon request and at the expense of Sponsor, the Institution shall assist Sponsor in securing and enforcing Sponsor’s rights in the Intellectual Property, including disclosure to Sponsor of all relevant or pertinent information and data with respect to such Intellectual Property and the execution of all oaths, assignments and other instruments necessary in order to apply for and obtain such rights and in order to assign and convey to Sponsor, its successors and assigns the sole and exclusive rights, title and interest in and to such Intellectual Property and any copyrights, patents or other intellectual property rights relating thereto. (d) Institution and Investigator warrant by the execution of this Agreement that they have not entered, and will not enter, into any contractual agreement or relationship which would in any way conflict with or compromise Sponsor’s rights to, any Study Results, inventions, discoveries, or technology arising out of or related to their performance thereunder. 4) Publicity and Publication. Sponsor shall have unrestricted publication rights for the Study Results and may give the data to third parties for publication. Quintiles and Sponsor recognize and acknowledge Institution’s interest in making publications relating to the Study in journals, at meetings or otherwise, for non-commercial purposes. Upon completion of the Study but not before the first publication of the consolidated Study results, or when data are adequate (in Sponsor’s reasonable judgement), the Institution has the right to prepare the data for publication. At least sixty (60) days prior to submitting or presenting a manuscript or other materials relating to the Study to a publisher, reviewer, or other outside persons, the Institution shall provide to Sponsor a copy of all such manuscripts and materials, and allow Sponsor sixty (60) days to review and comment on them. Unless Sponsor informs, the Institution and/or Investigator in writing during this sixty (60) day period that the proposed publication must be delayed in order to protect a patentable invention or changed a) to avoid disclosure of Confidential Information trade secrets or know-how, b) to ensure the accuracy of the presentation or publication, or c) to enable relevant supplementary information to be provided, Institution shall be free to publish the Study results Study results/data subject to the publication rules of this Section 4. In the event that a delay of the proposed publication is required, Institution shall withhold such submission for publication for an additional period agreed upon in good faith by the parties, however no longer than eighteen (18) months after submission of a respective patent application by Sponsor. The Institution agrees that if the Study is part of a multi-center study, any publication by the Institution of the results of the Study conducted at the Site shall not be made before the first multi-center publication; provided, however, that if no multi-center publication is made within one year from database lock, then the Institution may publish individually in accordance with this provision. For all publications relating to the Study or including any Study data, Sponsor, Site and Investigator agree to comply with the Good Publication Practise Guidelines (found at: xxxx://xxx.xxxxx.xxx) and all ethical standards concerning publications and authorship, including the rules of Good Scientific Practice, the guidelines for publications of clinical Study data as outlined e.g. by editors of the major medical journals as well as all ethical standards concerning publications and authorship, including the “Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals” as established by the International Committee of Medical Journal Editors (“ICMJE”) (found at xxxx://xxx.xxxxx.xxx). Authorship of any publications relating to the Study shall be determined by mutual agreement. Sponsor has the right to name co-authors. A representative of the Sponsor substantially involved in the implementation of the Study will serve as co-author in the primary full publication of the study, unless otherwise agreed. Institution shall oblige all its employees and other third parties participating in the conduct of the Study to comply with the above mentioned obligations. No party hereto shall use any other party’s name, or Sponsor’s name trademarks, logos, physical likeness, employee name, owner symbol, or other image, in connection with any advertising, publication or promotion as well as in any other publications, applications or forms without prior written permission, except that the Sponsor and Quintiles may use the Institution’s and Investigator’s name in Study publications and communications, including clinical trial websites and Study newsletters, and as stated in Section 4 of the Agreement. Furthermore, Sponsor, may use the name of Institution and/or Investigator in any publication, applications or forms, or other materials submitted to any regulatory authority and/or other disclosures required by Applicable Law such as disclosures in clinical trial registries. Designation of Business Secret. Parties hereby acknowledge and agree that Attachment B, the minimum enrollment goal, expected number of Study subjects enrolled and the expected duration of the Study, Investigator’s Brochure, Insurance Contract on Clinical Trial Insurance, Clinical Trial Protocol and personal data of the individuals, (further stated as „Trial Specific Confidential Information“), are deemed as information significant within the meaning of statutory definition of business secret (Section 504 of Act No. 89/2012 Coll., the Civil Code), as universal access to such information may have a substantial impact on economic results and market position of the Sponsor and members of the Sponsor’s group in other EU Member States. Trial Specific Confidential Information are either part of the text of the main Agreement or individual attachments to this Agreement. Institution and Investigator acknowledge that they also deem Trial Specific Confidential Information significant within the meaning of statutory definition of business secret (Section 504 of Act No. 89/2012 Coll., the Civil Code) and undertake to keep such information confidential in accordance with Section 2) hereof. Disclosure. The Parties hereby agree that in case Agreement must be disclosed pursuant to Act. No. 340/2015 Coll. on Special Conditions of Effectiveness of Certain Contracts, Publication thereof and the Contracts Register („Contract Registry Act“) or pursuant to other related legal regulations, they shall act as following:  • Institution shall disclose Agreement with respect to procedure indicated in this clause;  • Trial Specific Confidential Information and other confidential information according to the Article 2 of the Attachment A of this Agreement shall not be disclosed;  • For the purposes of disclosure, Institution shall provide to the Administrator of the Contract’s Register a copy of the signed Agreement in a format required by the Contract Registry Act;  • Institution shall inform Quintiles of the performed disclosure of the Agreement: (i) in the Contract Register, if possible, Institution shall include Quintiles’ email address for the purpose of provision of the confirmation about the disclosure of the Agreement; (ii) in case option (i) above could not be implemented, Institution shall within 5 10 business days as of receipt of the confirmation on the disclosure of the Agreement provide such information and the respective evidence to the Quintiles. For the purposes of this clause following email address of Quintiles shall be used: XXXXXXXXXXXXXXXXXXXXXXXXXXXX  XXXXXXXXXXXXXXXXXX • Institution shall disclose Agreement as well as provide confirmation about the disclosure to Quintiles as indicated above in this clause within 2 months 10 business days as of signing of the Agreement;  • In case the Agreement will be disclosed in breach with the Contract Registry Act and / or this Agreement, the Institution shall immediately but not later than within 2 days as of becoming aware of such breach or as of souladu se Zákonem o registru smluv a rovněž s touto Smlouvou; • V případě jakýchkoli dodatků zveřejněných informací informuje Zdravotnické zařízení o takových dodatcích okamžitě, ale ne později než během 2 pracovních dnů společnost Quintiles. receipt of the written request from the Quintiles eliminate the breach and ensure that the disclosure meets Contract Registry Act as well as this Agreement;  • In case any amendments would be performed to the disclosed information, Institution shall immediately but not later than within 2 business days inform Quintiles of such amendments. Without limiting application of the rules indicated in this clause above, Institution shall at all events disclose Agreement with respect to requirements established by the Contract Registry Act as well as any other applicable laws. Institution shall indemnify and hold Quintiles harmless for any damage resulting of a breach of the Contract Registry Act or other applicable laws by the Institution. 4.1. Proper performance of this clause is considered of significant importance for the purposes of this Agreement; breach of any obligations stipulated in this section will be considered as serious breach of the Agreement and any Party suffering by such breach shall be entitled to claim the incurred damages. 4.2. In case of any amendments to the Contract Registry Act and / or related legal requirements, Parties agree to amend this Agreement respectively, if needed.

Zveřejnění. Strany souhlasí, že v případě, že Xxxxxxx bude muset být zveřejněna podle zákona č. 340/2015 Sb., . o zvláštních podmínkách účinnosti některých smluv, uveřejňování těchto smluv a o registru smluv („zákon o registru smluv“) nebo podle dalších souvisejících regulačních opatření, provedou následující:  Zdravotnické zařízení zveřejní Xxxxxxx Smlouvu s ohledem na postup uvedený v tomto odstavci;  Důvěrné informace specifické pro klinické hodnocení a další důvěrné informace podle Článku 2 Přílohy A této Smlouvy nebudou zveřejněny;  Pro účely zveřejnění poskytne Zdravotnické zařízení Správci registru smluv kopii podepsané smlouvy ve formátu, který vyžaduje Zákon o registru smluv;  Zdravotnické zařízení bude informovat společnosti společnost Quintiles o provedeném zveřejnění Smlouvy: (i) v registru smluv, je-li to možné, Zdravotnické zařízení uvede emailovou adresu společnosti Quintiles pro účel poskytnutí potvrzení ohledně zveřejnění Smlouvy; (ii) v případě, že možnost (i) výše nelze provést, Zdravotnické zařízení poskytne během 5 pracovních dnů od přijetí potvrzení o zveřejnění Smlouvy takové informace a příslušné důkazy o tom, že Smlouva byla uveřejněna a předá je společnosti Quintiles. Pro účely tohoto odstavce bude použita následující emailová adresa společnosti Quintiles: XXXXXXXXXXXXXXXXXXXXXXXXXXXX  XXXXXXXXXXXXXXXX; Zdravotnické zařízení zveřejní Smlouva Smlouvu a rovněž poskytne potvrzení o zveřejnění společnosti Quintiles, jak je uvedeno výše v tomto odstavci během 2 měsíců 5 pracovních dnů od podpisu Smlouvy;  V případě, že Smlouva bude zveřejněna jako porušení Zákona v rozporu se Zákonem o registru smluv a/nebo této Smlouvytouto Smlouvou, Zdravotnické zařízení okamžitě, ale ne později než 2 dny od okamžiku, kdy se dozví o takovém porušení nebo od přijetí písemného požadavku od společnosti Quintiles odstraní porušení Quintiles, zjedná nápravu a zajistí, že aby zveřejnění je bylo v souladu se Zákonem o registru smluv a rovněž s touto Smlouvou;  V případě jakýchkoli dodatků případě, že budou ve zveřejněných informací informuje informacích provedeny změny, bude Zdravotnické zařízení o takových dodatcích okamžitěneprodleně, ale ne později než během nejpozději však do 2 pracovních dnů o těchto změnách informovat společnost Quintiles. Bez omezení uplatňování pravidel uvedených v tomto článku výše musí Zdravotnické zařízení v každém případě zveřejnit Smlouvu s ohledem na požadavky stanovené Zákonem o registru smluv, jakož i jakýchkoli jiných platných zákonů. Zdravotnické zařízení odškodní a zajistí ochranu společnosti Quintiles proti jakýmkoli případným škodám vzniklým z porušení Zákona o registru smluv nebo jiných platných zákonů ze strany Zdravotnického zařízení. 4.1. Řádné plnění tohoto odstavce je považováno za podstatně významné pro účely této Smlouvy; porušení jakýchkoliv povinností stanovených v tomto oddíle bude považováno za závažné porušení Smlouvy a kterákoli strana, která utrpí újmu takovým porušením má nárok na náhradu škod. 4.2. V případě jakýchkoli dodatků Zákona o registru smluv a/nebo souvisejících zákonných požadavků Strany souhlasí, že příslušným způsobem upraví tuto Smlouvu, bude-li třeba. 3) Ownership and Intellectual Property Rights Proprietary Information: All documents, data, know-how, formulas, protein and DNA sequences, and the Investigational Product, comparator, placebo provided to the Institution or Investigator for purposes of the Study are and shall remain the property of Sponsor and will be returned to Sponsor, Quintiles, or their respective designees upon request. Rights to Results: All data, information and materials developed or generated by Institution or Investigator as a result, or arising out, of the Study (“Study Results”) shall be the sole and exclusive property of Sponsor. Sponsor may use Study Results in connection with any of its research, development, marketing or promotional activities and in any other manner deemed appropriate to Sponsor's business interests. The Institution assigns all rights of Study Results obtained in the Study to Sponsor. Investigator shall notify Quintiles or Sponsor of the Study Results promptly, separately and in writing. Intellectual Property: (a) As used herein, “Intellectual Property” shall mean all rights, title and interest in and to the intellectual property and materials that are the subject of the Study or the Protocol, including, without limitation, all property rights in the Investigational Product and all data, technical information, inventions, discoveries, developments, improvements, enhancements, software, know-how, methods, techniques, formulae, data, processes and other proprietary ideas (whether or not patentable or registrable under patent, copyright or similar laws) and materials related to any product (including, without limitation, the Investigational Product), the Study or the Protocol, or otherwise derived, conceived, discovered, developed or reduced to practice as a direct or indirect result of the Institution’s performance of any services under or pursuant to this Agreement or during the course of or in connection with the Study whether generated or developed by the Institution, Quintiles or Sponsor or their respective agents, employees or contractors, either solely or jointly with others. Institution and Investigator acknowledge that all Intellectual Property shall be considered Confidential Information subject to Section 2. (b) All Intellectual Property shall be the sole and exclusive property of Sponsor. The Institution, including its employees or agents, shall not acquire any Intellectual Property or any other rights of any kind whatsoever with respect to the Investigational Product as a result of performance under this Agreement. The Institution hereby agrees to assign and herewith assigns to Sponsor all Intellectual Property and other rights resulting from the Study and the work under this Agreement. At all times, Sponsor shall have the exclusive right to use, assign, license or transfer ownership of any Intellectual Property without payment of any compensation to the Institution for such Intellectual Property. (c) The Institution agrees to promptly notify Sponsor of any such Intellectual Property invention, discovery or improvement, and to make all statements legally necessary to vest title in such invention, discovery or improvement in Sponsor. Sponsor shall have the sole and exclusive right to obtain, file and prosecute in its own name and at its expense, applications for patents on any information derived from Intellectual Property. Upon request and at the expense of Sponsor, the Institution shall assist Sponsor in securing and enforcing Sponsor’s rights in the Intellectual Property, including disclosure to Sponsor of all relevant or pertinent information and data with respect to such Intellectual Property and the execution of all oaths, assignments and other instruments necessary in order to apply for and obtain such rights and in order to assign and convey to Sponsor, its successors and assigns the sole and exclusive rights, title and interest in and to such Intellectual Property and any copyrights, patents or other intellectual property rights relating thereto. (d) Institution and Investigator warrant by the execution of this Agreement that they have not entered, and will not enter, into any contractual agreement or relationship which would in any way conflict with or compromise Sponsor’s rights to, any Study Results, inventions, discoveries, or technology arising out of or related to their performance thereunder. 4) Publicity and Publication. Sponsor shall have unrestricted publication rights for the Study Results and may give the data to third parties for publication. Quintiles and Sponsor recognize and acknowledge InstitutionSite’s interest in making publications relating to the Study in journals, at meetings or otherwise, for non-commercial purposes. Upon completion of the Study but not before the first publication of the consolidated Study results, or when data are adequate (in Sponsor’s reasonable judgement), the Institution Site has the right to prepare the data for publication. At least sixty (60) days prior to submitting or presenting a manuscript or other materials relating to the Study to a publisher, reviewer, or other outside persons, the Institution Site shall provide to Sponsor a copy of all such manuscripts and materials, and allow Sponsor sixty (60) days to review and comment on them. Unless Sponsor informs, informs the Institution and/or Investigator Site in writing during this sixty (60) day period that the proposed publication must be delayed in order to protect a patentable invention or changed a) to avoid disclosure of Confidential Information Information, trade secrets or know-how, b) to ensure the accuracy of the presentation or publication, or c) to enable relevant supplementary information to be provided, Institution Site shall be free to publish the Study results Study results/data subject to the publication rules of this Section 4. In the event that a delay of the proposed publication is required, Institution Site shall withhold such submission for publication for an additional period agreed upon in good faith by the parties, however no longer than eighteen (18) months after submission of a respective patent application by Sponsor. The Institution Site agrees that if the Study is part of a multi-center study, any publication by the Institution Site of the results of the Study conducted at the Site shall not be made before the first multi-center publication; provided, however, that if no multi-center publication is made within one year from database lock, then the Institution Site may publish individually in accordance with this provision. For all publications relating to the Study or including any Study data, Sponsor, Site and Investigator agree to comply with the Good Publication Practise Guidelines (found at: xxxx://xxx.xxxxx.xxx) and all ethical standards concerning publications and authorship, including the rules of Good Scientific Practice, the guidelines for publications of clinical Study data as outlined e.g. by editors of the major medical journals as well as all ethical standards concerning publications and authorship, including the “Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals” as established by the International Committee of Medical Journal Editors (“ICMJE”) (found at xxxx://xxx.xxxxx.xxx). Authorship of any publications relating to the Study shall be determined by mutual agreement. Sponsor has the right to name co-authors. A representative of the Sponsor substantially involved in the implementation of the Study will serve as co-author in the primary full publication of the study, unless otherwise agreed. Institution Site shall oblige all its employees and other third parties participating in the conduct of the Study to comply with the above mentioned obligations. No party hereto shall use any other party’s name, or Sponsor’s name name, trademarks, logos, physical likeness, employee name, owner symbol, or other image, image in connection with any advertising, publication or promotion as well as in any other publications, applications or forms forms, without prior written permission, except that the Sponsor and Quintiles may use the Institution’s and InvestigatorSite’s name in Study publications and communications, including clinical trial websites and Study newsletters, and as stated in Section 4 of the Agreement. Furthermore, Sponsor, may use the name of Institution and/or Investigator in any publication, applications or forms, or other materials submitted to any regulatory authority and/or other disclosures required by Applicable Law such as disclosures in clinical trial registries. Designation of Business Secret. Parties hereby acknowledge and agree that Attachment B, the minimum enrollment goal, expected number of Study subjects enrolled and the expected duration of the Study, Investigator’s Brochure, Insurance Contract on Clinical Trial Insurance, Clinical Trial Protocol and personal data of the individuals, (further stated as „Trial Specific Confidential Information“), are deemed as information significant within the meaning of statutory definition of business secret (Section 504 of Act No. 89/2012 Coll., the Civil Code), as universal access to such information may have a substantial impact on economic results and market position of the Sponsor and members of the Sponsor’s group in other EU Member States. Trial Specific Confidential Information are either part of the text of the main Agreement or individual attachments to this Agreement. Institution and Investigator acknowledge that they also deem Trial Specific Confidential Information significant within the meaning of statutory definition of business secret (Section 504 of Act No. 89/2012 Coll., the Civil Code) and undertake to keep such information confidential in accordance with Section 2) hereof. Disclosure. The Parties hereby agree that in case Agreement must be disclosed pursuant to Act. No. 340/2015 Coll. on Special Conditions of Effectiveness of Certain Contracts, Publication thereof and the Contracts Register („Contract Registry Act“”) or pursuant to other related legal regulations, they shall act as following:  Institution shall disclose Agreement with respect to procedure indicated in this clause;  Trial Specific Confidential Information and other confidential information according to the Article 2 of the Attachment A of this Agreement shall not be disclosed;  For the purposes of disclosure, Institution shall provide to the Administrator of the Contract’s Register a copy of the signed Agreement in a format required by the Contract Registry Act;  Institution shall inform Quintiles of the performed disclosure of the Agreement: (i) in the Contract Register, if possible, Institution shall include Quintiles’ email address for the purpose of provision of the confirmation about the disclosure of the Agreement; (ii) in case option (i) above could not be implemented, Institution shall within 5 business days as of receipt of the confirmation on the disclosure of the Agreement provide such information and the respective evidence of the Agreement´s disclosure to the Quintiles. For the purposes of this clause following email address of Quintiles shall be used: XXXXXXXXXXXXXXXXXXXXXXXXXXXX  XXXXXXXXXXXXXXX; Institution shall disclose Agreement as well as provide confirmation about the disclosure to Quintiles as indicated above in this clause within 2 months 5 business days as of signing of the Agreement;  In case the Agreement will be disclosed in breach with the Contract Registry Act and / or this Agreement, the Institution shall immediately but not later than within 2 days as of becoming aware of such breach or as of receipt of the written request from the Quintiles eliminate the breach and ensure that the disclosure meets Contract Registry Act as well as this Agreement;  In case any amendments would be performed to the disclosed information, Institution shall immediately but not later than within 2 business days inform Quintiles of such amendments. Without limiting application of the rules indicated in this clause above, Institution shall at all events disclose Agreement with respect to requirements established by the Contract Registry Act as well as any other applicable laws. Institution shall indemnify and hold Quintiles harmless for any damage resulting of a breach of the Contract Registry Act or other applicable laws by the Institution. 4.1. Proper performance of this clause is considered of significant importance for the purposes of this Agreement; breach of any obligations stipulated in this section will be considered as serious breach of the Agreement and any Party suffering by such breach shall be entitled to claim the incurred damages. 4.2. In case of any amendments to the Contract Registry Act and / or related legal requirements, Parties agree to amend this Agreement respectively, if needed.

Zveřejnění. Strany tímto souhlasí, že v případě, že Xxxxxxx bude muset Smlouva musí být zveřejněna podle zákona v souladu se zákonem č. 340/2015 Sb., zákon o zvláštních podmínkách účinnosti některých smluv, uveřejňování těchto smluv a o registru smluv („zákon Zákon o registru smluv“) nebo podle dalších souvisejících regulačních opatřenína základě ostatní související platné právní úpravy, provedou následujícíbudou jednat v souladu s následujícím:  Zdravotnické zařízení zveřejní Xxxxxxx Smlouvu v souladu s ohledem na postup uvedený postupem definovaným v tomto odstavcičlánku;  Důvěrné informace specifické pro klinické hodnocení údaje v rámci Studie a další ostatní důvěrné informace podle Článku 2 této Smlouvy nebudou zveřejněnyzveřejněny či jinak odhaleny;  Pro účely zveřejnění poskytne se Zdravotnické zařízení Správci registru zavazuje, že poskytne správci Registru smluv kopii podepsané smlouvy Smlouvy ve formátu, který vyžaduje Zákon formátu požadovaném Zákonem o registru smluv, a to v redigované podobě poskytnuté Quintiles Zdravotnickému zařízení před podpisem této Smlouvy;  Zdravotnické zařízení se zavazuje, že bude informovat společnosti Quintiles o provedeném provedení zveřejnění Smlouvy: (i) v registru Registru smluv, jea bude-li to možné, Zdravotnické zařízení uvede emailovou zahrne e-mailovou adresu společnosti Quintiles Quintiles, a to pro účel účely poskytnutí potvrzení ohledně o zveřejnění Smlouvy; (ii) v případě, že možnost (i) výše nelze provéstnebude možné uplatnit, Zdravotnické zařízení poskytne během do 5 pracovních dnů od přijetí potvrzení o zveřejnění Smlouvy takové informace poskytne takovou informaci a příslušné důkazy odpovídající důkaz této skutečnosti společnosti Quintiles. Pro účely tohoto odstavce bude použita následující emailová e-mailová adresa společnosti Quintiles: XXXXXXXXXXXXXXXXXXXXXXXXXXXX ;  Zdravotnické zařízení zveřejní Smlouva Smlouvu a rovněž poskytne potvrzení o zveřejnění společnosti Quintiles, jak je uvedeno výše v tomto odstavci během Quintiles způsobem shora vymezeným ve lhůtě 2 měsíců od podpisu této Smlouvy;  V případě, že bude Smlouva bude zveřejněna jako porušení Zákona v rozporu se Zákonem o registru smluv a/a / nebo této Smlouvytouto Smlouvou, Zdravotnické zařízení okamžitěse zavazuje, ale ne později než 2 že neprodleně, xxxxxx xxxx xxxx xxx 0 dny od okamžiku, kdy se dozví o takovém porušení dozví nebo od v návaznosti na přijetí písemného požadavku od společnosti Quintiles odstraní porušení a zajistí, že zveřejnění je v souladu se Zákonem o registru smluv a rovněž s touto Smlouvou;  V případě jakýchkoli dodatků zveřejněných informací informuje Zdravotnické zařízení o takových dodatcích okamžitě, ale ne později než během 2 pracovních dnů společnost Quintiles. Bez omezení uplatňování pravidel uvedených v tomto článku výše musí Zdravotnické zařízení v každém případě zveřejnit Smlouvu s ohledem na požadavky stanovené Zákonem o registru smluv, jakož i jakýchkoli jiných platných zákonů. Zdravotnické zařízení odškodní a zajistí ochranu společnosti Quintiles proti jakýmkoli případným škodám vzniklým z porušení Zákona o registru smluv nebo jiných platných zákonů ze strany Zdravotnického zařízení. 4.1. Řádné plnění tohoto odstavce je považováno za podstatně významné pro účely této Smlouvy; porušení jakýchkoliv povinností stanovených v tomto oddíle bude považováno za závažné porušení Smlouvy a kterákoli strana, která utrpí újmu takovým porušením má nárok na náhradu škod. 4.2. V případě jakýchkoli dodatků Zákona o registru smluv a/nebo souvisejících zákonných požadavků Strany souhlasí, že příslušným způsobem upraví tuto Smlouvu, bude-li třeba. 3) Ownership and Intellectual Property Rights Proprietary Information: All documents, data, know-how, formulas, protein and DNA sequences, and the Investigational Product, comparator, placebo provided to the Institution or Investigator for purposes of the Study are and shall remain the property of Sponsor and will be returned to Sponsor, Quintiles, or their respective designees upon request. Rights to Results: All data, information and materials developed or generated by Institution or Investigator as a result, or arising out, of the Study (“Study Results”) shall be the sole and exclusive property of Sponsor. Sponsor may use Study Results in connection with any of its research, development, marketing or promotional activities and in any other manner deemed appropriate to Sponsor's business interests. The Institution assigns all rights of Study Results obtained in the Study to Sponsor. Investigator shall notify Quintiles or Sponsor of the Study Results promptly, separately and in writing. Intellectual Property: (a) As used herein, “Intellectual Property” shall mean all rights, title and interest in and to the intellectual property and materials that are the subject of the Study or the Protocol, including, without limitation, all property rights in the Investigational Product and all data, technical information, inventions, discoveries, developments, improvements, enhancements, software, know-how, methods, techniques, formulae, data, processes and other proprietary ideas (whether or not patentable or registrable under patent, copyright or similar laws) and materials related to any product (including, without limitation, the Investigational Product), the Study or the Protocol, or otherwise derived, conceived, discovered, developed or reduced to practice as a direct or indirect result of the Institution’s performance of any services under or pursuant to this Agreement or during the course of or in connection with the Study whether generated or developed by the Institution, Quintiles or Sponsor or their respective agents, employees or contractors, either solely or jointly with others. Institution and Investigator acknowledge that all Intellectual Property shall be considered Confidential Information subject to Section 2. (b) All Intellectual Property shall be the sole and exclusive property of Sponsor. The Institution, including its employees or agents, shall not acquire any Intellectual Property or any other rights of any kind whatsoever with respect to the Investigational Product as a result of performance under this Agreement. The Institution hereby agrees to assign and herewith assigns to Sponsor all Intellectual Property and other rights resulting from the Study and the work under this Agreement. At all times, Sponsor shall have the exclusive right to use, assign, license or transfer ownership of any Intellectual Property without payment of any compensation to the Institution for such Intellectual Property. (c) The Institution agrees to promptly notify Sponsor of any such Intellectual Property invention, discovery or improvement, and to make all statements legally necessary to vest title in such invention, discovery or improvement in Sponsor. Sponsor shall have the sole and exclusive right to obtain, file and prosecute in its own name and at its expense, applications for patents on any information derived from Intellectual Property. Upon request and at the expense of Sponsor, the Institution shall assist Sponsor in securing and enforcing Sponsor’s rights in the Intellectual Property, including disclosure to Sponsor of all relevant or pertinent information and data with respect to such Intellectual Property and the execution of all oaths, assignments and other instruments necessary in order to apply for and obtain such rights and in order to assign and convey to Sponsor, its successors and assigns the sole and exclusive rights, title and interest in and to such Intellectual Property and any copyrights, patents or other intellectual property rights relating thereto. (d) Institution and Investigator warrant by the execution of this Agreement that they have not entered, and will not enter, into any contractual agreement or relationship which would in any way conflict with or compromise Sponsor’s rights to, any Study Results, inventions, discoveries, or technology arising out of or related to their performance thereunder. 4) Publicity and Publication. Sponsor shall have unrestricted publication rights for the Study Results and may give the data to third parties for publication. Quintiles and Sponsor recognize and acknowledge Institution’s interest in making publications relating to the Study in journals, at meetings or otherwise, for non-commercial purposes. Upon completion of the Study but not before the first publication of the consolidated Study results, or when data are adequate (in Sponsor’s reasonable judgement), the Institution has the right to prepare the data for publication. At least sixty (60) days prior to submitting or presenting a manuscript or other materials relating to the Study to a publisher, reviewer, or other outside persons, the Institution shall provide to Sponsor a copy of all such manuscripts and materials, and allow Sponsor sixty (60) days to review and comment on them. Unless Sponsor informs, the Institution and/or Investigator in writing during this sixty (60) day period that the proposed publication must be delayed in order to protect a patentable invention or changed a) to avoid disclosure of Confidential Information trade secrets or know-how, b) to ensure the accuracy of the presentation or publication, or c) to enable relevant supplementary information to be provided, Institution shall be free to publish the Study results Study results/data subject to the publication rules of this Section 4. In the event that a delay of the proposed publication is required, Institution shall withhold such submission for publication for an additional period agreed upon in good faith by the parties, however no longer than eighteen (18) months after submission of a respective patent application by Sponsor. The Institution agrees that if the Study is part of a multi-center study, any publication by the Institution of the results of the Study conducted at the Site shall not be made before the first multi-center publication; provided, however, that if no multi-center publication is made within one year from database lock, then the Institution may publish individually in accordance with this provision. For all publications relating to the Study or including any Study data, Sponsor, Site and Investigator agree to comply with the Good Publication Practise Guidelines (found at: xxxx://xxx.xxxxx.xxx) and all ethical standards concerning publications and authorship, including the rules of Good Scientific Practice, the guidelines for publications of clinical Study data as outlined e.g. by editors of the major medical journals as well as all ethical standards concerning publications and authorship, including the “Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals” as established by the International Committee of Medical Journal Editors (“ICMJE”) (found at xxxx://xxx.xxxxx.xxx). Authorship of any publications relating to the Study shall be determined by mutual agreement. Sponsor has the right to name co-authors. A representative of the Sponsor substantially involved in the implementation of the Study will serve as co-author in the primary full publication of the study, unless otherwise agreed. Institution shall oblige all its employees and other third parties participating in the conduct of the Study to comply with the above mentioned obligations. No party hereto shall use any other party’s name, or Sponsor’s name trademarks, logos, physical likeness, employee name, owner symbol, or other image, in connection with any advertising, publication or promotion as well as in any other publications, applications or forms without prior written permission, except that the Sponsor and Quintiles may use the Institution’s and Investigator’s name in Study publications and communications, including clinical trial websites and Study newsletters, and as stated in Section 4 of the Agreement. Furthermore, Sponsor, may use the name of Institution and/or Investigator in any publication, applications or forms, or other materials submitted to any regulatory authority and/or other disclosures required by Applicable Law such as disclosures in clinical trial registries. Designation of Business Secret. Parties hereby acknowledge and agree that Attachment B, the minimum enrollment goal, expected number of Study subjects enrolled and the expected duration of the Study, Investigator’s Brochure, Insurance Contract on Clinical Trial Insurance, Clinical Trial Protocol and personal data of the individuals, (further stated as „Trial Specific Confidential Information“), are deemed as information significant within the meaning of statutory definition of business secret (Section 504 of Act No. 89/2012 Coll., the Civil Code), as universal access to such information may have a substantial impact on economic results and market position of the Sponsor and members of the Sponsor’s group in other EU Member States. Trial Specific Confidential Information are either part of the text of the main Agreement or individual attachments to this Agreement. Institution and Investigator acknowledge that they also deem Trial Specific Confidential Information significant within the meaning of statutory definition of business secret (Section 504 of Act No. 89/2012 Coll., the Civil Code) and undertake to keep such information confidential in accordance with Section 2) hereof. Disclosure. The Parties hereby agree that in case Agreement must be disclosed pursuant to Act. No. 340/2015 Coll. on Special Conditions of Effectiveness of Certain Contracts, Publication thereof and the Contracts Register („Contract Registry Act“) or pursuant to other related legal regulations, they shall act as following:  Institution shall disclose Agreement with respect to procedure indicated in this clause;  Trial Specific Confidential Information and other confidential information according to the Article 2 of this Agreement shall not be disclosed;  For the purposes of disclosure, Institution shall provide to the Administrator of the Contract’s Register a copy of the signed Agreement in a format required by the Contract Registry Act, and in redacted version provided by Quintiles to Institution prior to execution of this Agreement;  Institution shall inform Quintiles of the performed disclosure of the Agreement: (i) in the Contract Register, if possible, Institution shall include Quintiles’ email address for the purpose of provision of the confirmation about the disclosure of the Agreement; (ii) in case option (i) above could not be implemented, Institution shall within 5 business days as of receipt of the confirmation on the disclosure of the Agreement provide such information and the respective evidence to the Quintiles. For the purposes of this clause following email address of Quintiles shall be used: XXXXXXXXXXXXXXXXXXXXXXXXXXXX  Institution shall disclose Agreement as well as provide confirmation about the disclosure to Quintiles as indicated above in this clause within 2 months as of signing of the Agreement;  In case the Agreement will be disclosed in breach with the Contract Registry Act and / or this Agreement, the Institution shall immediately but not later than within 2 days as of becoming aware of such breach or as of receipt of the written request from the Quintiles eliminate the breach and ensure that the disclosure meets Contract Registry Act as well as this Agreement;  In case any amendments would be performed to the disclosed information, Institution shall immediately but not later than within 2 business days inform Quintiles of such amendments. Without limiting application of the rules indicated in this clause above, Institution shall at all events disclose Agreement with respect to requirements established by the Contract Registry Act as well as any other applicable laws. Institution shall indemnify and hold Quintiles harmless for any damage resulting of a breach of the Contract Registry Act or other applicable laws by the Institution. 4.1. Proper performance of this clause is considered of significant importance for the purposes of this Agreement; breach of any obligations stipulated in this section will be considered as serious breach of the Agreement and any Party suffering by such breach shall be entitled to claim the incurred damages. 4.2. In case of any amendments to the Contract Registry Act and / or related legal requirements, Parties agree to amend this Agreement respectively, if needed.Registry

Zveřejnění. Strany souhlasí, že v případě, že Xxxxxxx bude muset být zveřejněna podle zákona č. 340/2015 Sb., . o zvláštních podmínkách účinnosti některých smluv, uveřejňování těchto smluv a o registru smluv („zákon o registru smluv“) nebo podle dalších souvisejících regulačních opatření, provedou následující:  Zdravotnické zařízení zveřejní Xxxxxxx Smlouvu s ohledem na postup uvedený v tomto odstavci;  Důvěrné informace specifické pro klinické hodnocení a další důvěrné informace podle Článku 2 této Smlouvy nebudou zveřejněny;  Pro účely zveřejnění poskytne Zdravotnické zařízení Správci registru smluv kopii podepsané smlouvy ve formátu, který vyžaduje Zákon o registru smluv;  Zdravotnické zařízení bude informovat společnosti Quintiles o provedeném zveřejnění Smlouvy: (i) v registru smluv, je-li to možné, Zdravotnické zařízení uvede emailovou adresu společnosti Quintiles pro účel poskytnutí potvrzení ohledně zveřejnění Smlouvy; (ii) v případě, že možnost (i) výše nelze provést, Zdravotnické zařízení poskytne během 5 pracovních dnů od přijetí potvrzení o zveřejnění Smlouvy takové informace a příslušné důkazy společnosti Quintiles. Pro účely tohoto odstavce bude použita následující emailová adresa společnosti Quintiles: XXXXXXXXXXXXXXXXXXXXXXXXXXXX XXXXXXXXXXXXXXXXXXXXXXXX  Zdravotnické zařízení zveřejní Smlouva Smlouvu a rovněž poskytne potvrzení o zveřejnění společnosti Quintiles, jak je uvedeno výše v tomto odstavci během 2 měsíců od podpisu Smlouvy;  V případě, že Smlouva bude zveřejněna jako porušení Zákona o registru smluv a/nebo této Smlouvy, Zdravotnické zařízení okamžitě, ale ne později než 2 dny od okamžiku, kdy se dozví o takovém porušení nebo od přijetí písemného požadavku od společnosti Quintiles odstraní porušení a zajistí, že zveřejnění je v souladu se Zákonem o registru smluv a rovněž s touto Smlouvou;  V případě jakýchkoli dodatků zveřejněných informací informuje Zdravotnické zařízení o takových dodatcích okamžitě, ale ne později než během 2 pracovních dnů společnost Quintiles. Bez omezení uplatňování pravidel uvedených v tomto článku výše musí Zdravotnické zařízení v každém případě zveřejnit Smlouvu s ohledem na požadavky stanovené Zákonem o registru smluv, jakož i jakýchkoli jiných platných zákonů. Zdravotnické zařízení odškodní a zajistí ochranu společnosti Quintiles proti jakýmkoli případným škodám vzniklým z porušení Zákona o registru smluv nebo jiných platných zákonů ze strany Zdravotnického zařízení. 4.1. Řádné plnění tohoto odstavce je považováno za podstatně významné pro účely této Smlouvy; porušení jakýchkoliv povinností stanovených v tomto oddíle bude považováno za závažné porušení Smlouvy a kterákoli strana, která utrpí újmu takovým porušením má nárok na náhradu škod. 4.2. V případě jakýchkoli dodatků Zákona o registru smluv a/nebo souvisejících zákonných požadavků Strany souhlasí, že příslušným způsobem upraví tuto Smlouvu, bude-li třeba. 3) Ownership and Intellectual Property Rights Proprietary Information: All documents, data, know-how, formulas, protein and DNA sequences, and the Investigational Product, comparator, placebo provided to the Institution or Investigator for purposes of the Study are and shall remain the property of Sponsor and will be returned to Sponsor, Quintiles, or their respective designees upon request. Rights to Results: All data, information and materials developed or generated by Institution or Investigator as a result, or arising out, of the Study (“Study Results”) shall be the sole and exclusive property of Sponsor. Sponsor may use Study Results in connection with any of its research, development, marketing or promotional activities and in any other manner deemed appropriate to Sponsor's business interests. The Institution assigns all rights of Study Results obtained in the Study to Sponsor. Investigator shall notify Quintiles or Sponsor of the Study Results promptly, separately and in writing. Intellectual Property: (a) As used herein, “Intellectual Property” shall mean all rights, title and interest in and to the intellectual property and materials that are the subject of the Study or the Protocol, including, without limitation, all property rights in the Investigational Product and all data, technical information, inventions, discoveries, developments, improvements, enhancements, software, know-how, methods, techniques, formulae, data, processes and other proprietary ideas (whether or not patentable or registrable under patent, copyright or similar laws) and materials related to any product (including, without limitation, the Investigational Product), the Study or the Protocol, or otherwise derived, conceived, discovered, developed or reduced to practice as a direct or indirect result of the Institution’s performance of any services under or pursuant to this Agreement or during the course of or in connection with the Study whether generated or developed by the Institution, Quintiles or Sponsor or their respective agents, employees or contractors, either solely or jointly with others. Institution and Investigator acknowledge that all Intellectual Property shall be considered Confidential Information subject to Section 2. (b) All Intellectual Property shall be the sole and exclusive property of Sponsor. The Institution, including its employees or agents, shall not acquire any Intellectual Property or any other rights of any kind whatsoever with respect to the Investigational Product as a result of performance under this Agreement. The Institution hereby agrees to assign and herewith assigns to Sponsor all Intellectual Property and other rights resulting from the Study and the work under this Agreement. At all times, Sponsor shall have the exclusive right to use, assign, license or transfer ownership of any Intellectual Property without payment of any compensation to the Institution for such Intellectual Property. (c) The Institution agrees to promptly notify Sponsor of any such Intellectual Property invention, discovery or improvement, and to make all statements legally necessary to vest title in such invention, discovery or improvement in Sponsor. Sponsor shall have the sole and exclusive right to obtain, file and prosecute in its own name and at its expense, applications for patents on any information derived from Intellectual Property. Upon request and at the expense of Sponsor, the Institution shall assist Sponsor in securing and enforcing Sponsor’s rights in the Intellectual Property, including disclosure to Sponsor of all relevant or pertinent information and data with respect to such Intellectual Property and the execution of all oaths, assignments and other instruments necessary in order to apply for and obtain such rights and in order to assign and convey to Sponsor, its successors and assigns the sole and exclusive rights, title and interest in and to such Intellectual Property and any copyrights, patents or other intellectual property rights relating thereto. (d) Institution and Investigator warrant by the execution of this Agreement that they have not entered, and will not enter, into any contractual agreement or relationship which would in any way conflict with or compromise Sponsor’s rights to, any Study Results, inventions, discoveries, or technology arising out of or related to their performance thereunder. 4) Publicity and Publication. Sponsor shall have unrestricted publication rights for the Study Results and may give the data to third parties for publication. Quintiles and Sponsor recognize and acknowledge InstitutionSite’s interest in making publications relating to the Study in journals, at meetings or otherwise, for non-commercial purposes. Upon completion of the Study but not before the first publication of the consolidated Study results, or when data are adequate (in Sponsor’s reasonable judgement), the Institution Site has the right to prepare the data for publication. At least sixty (60) days prior to submitting or presenting a manuscript or other materials relating to the Study to a publisher, reviewer, or other outside persons, the Institution Site shall provide to Sponsor a copy of all such manuscripts and materials, and allow Sponsor sixty (60) days to review and comment on them. Unless Sponsor informs, informs the Institution and/or Investigator Site in writing during this sixty (60) day period that the proposed publication must be delayed in order to protect a patentable invention or changed a) to avoid disclosure of Confidential Information Information, trade secrets or know-how, b) to ensure the accuracy of the presentation or publication, or c) to enable relevant supplementary information to be provided, Institution Site shall be free to publish the Study results Study results/data subject to the publication rules of this Section 4. In the event that a delay of the proposed publication is required, Institution Site shall withhold such submission for publication for an additional period agreed upon in good faith by the parties, however no longer than eighteen (18) months after submission of a respective patent application by Sponsor. The Institution Site agrees that if the Study is part of a multi-center study, any publication by the Institution Site of the results of the Study conducted at the Site shall not be made before the first multi-center publication; provided, however, that if no multi-center publication is made within one year from database lock, then the Institution Site may publish individually in accordance with this provision. For all publications relating to the Study or including any Study data, Sponsor, Site and Investigator agree to comply with the Good Publication Practise Guidelines (found at: xxxx://xxx.xxxxx.xxx) and all ethical standards concerning publications and authorship, including the rules of Good Scientific Practice, the guidelines for publications of clinical Study data as outlined e.g. by editors of the major medical journals as well as all ethical standards concerning publications and authorship, including the “Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals” as established by the International Committee of Medical Journal Editors (“ICMJE”) (found at xxxx://xxx.xxxxx.xxx). Authorship of any publications relating to the Study shall be determined by mutual agreement. Sponsor has the right to name co-authors. A representative of the Sponsor substantially involved in the implementation of the Study will serve as co-author in the primary full publication of the study, unless otherwise agreed. Institution Site shall oblige all its employees and other third parties participating in the conduct of the Study to comply with the above mentioned obligations. No party hereto shall use any other party’s name, or Sponsor’s name name, trademarks, logos, physical likeness, employee name, owner symbol, or other image, image in connection with any advertising, publication or promotion as well as in any other publications, applications or forms forms, without prior written permission, except that the Sponsor and Quintiles may use the Institution’s and InvestigatorSite’s name in Study publications and communications, including clinical trial websites and Study newsletters, and as stated in Section 4 of the Agreement. Furthermore, Sponsor, may use the name of Institution and/or Investigator in any publication, applications or forms, or other materials submitted to any regulatory authority and/or other disclosures required by Applicable Law such as disclosures in clinical trial registries. Designation of Business Secret. Parties hereby acknowledge and agree that Attachment B, the minimum enrollment goal, expected number of Study subjects enrolled and the expected duration of the Study, Investigator’s Brochure, Insurance Contract on Clinical Trial Insurance, Clinical Trial Protocol and personal data of the individuals, (further stated as „Trial Specific Confidential Information“), are deemed as information significant within the meaning of statutory definition of business secret (Section 504 of Act No. 89/2012 Coll., the Civil Code), as universal access to such information may have a substantial impact on economic results and market position of the Sponsor and members of the Sponsor’s group in other EU Member States. Trial Specific Confidential Information are either part of the text of the main Agreement or individual attachments to this Agreement. Institution and Investigator acknowledge that they also deem Trial Specific Confidential Information significant within the meaning of statutory definition of business secret (Section 504 of Act No. 89/2012 Coll., the Civil Code) and undertake to keep such information confidential in accordance with Section 2) hereof. Disclosure. The Parties hereby agree that in case Agreement must be disclosed pursuant to Act. No. 340/2015 Coll. on Special Conditions of Effectiveness of Certain Contracts, Publication thereof and the Contracts Register („Contract Registry Act“) or pursuant to other related legal regulations, they shall act as following:  Institution shall disclose Agreement with respect to procedure indicated in this clause;  Trial Specific Confidential Information and other confidential information according to the Article 2 of this Agreement shall not be disclosed;  For the purposes of disclosure, Institution shall provide to the Administrator of the Contract’s Register a copy of the signed Agreement in a format required by the Contract Registry Act;  Institution shall inform Quintiles of the performed disclosure of the Agreement: (i) in the Contract Register, if possible, Institution shall include Quintiles’ email address for the purpose of provision of the confirmation about the disclosure of the Agreement; (ii) in case option (i) above could not be implemented, Institution shall within 5 business days as of receipt of the confirmation on the disclosure of the Agreement provide such information and the respective evidence to the Quintiles. For the purposes of this clause following email address of Quintiles shall be used: XXXXXXXXXXXXXXXXXXXXXXXXXXXX XXXXXXXXXXXXXXXXXXXXXXXX  Institution shall disclose Agreement as well as provide confirmation about the disclosure to Quintiles as indicated above in this clause within 2 months as of signing of the Agreement;  In case the Agreement will be disclosed in breach with the Contract Registry Act and / or this Agreement, the Institution shall immediately but not later than within 2 days as of becoming aware of such breach or as of receipt of the written request from the Quintiles eliminate the breach and ensure that the disclosure meets Contract Registry Act as well as this Agreement;  In case any amendments would be performed to the disclosed information, Institution shall immediately but not later than within 2 business days inform Quintiles of such amendments. Without limiting application of the rules indicated in this clause above, Institution shall at all events disclose Agreement with respect to requirements established by the Contract Registry Act as well as any other applicable laws. Institution shall indemnify and hold Quintiles harmless for any damage resulting of a breach of the Contract Registry Act or other applicable laws by the Institution. 4.1. Proper performance of this clause is considered of significant importance for the purposes of this Agreement; breach of any obligations stipulated in this section will be considered as serious breach of the Agreement and any Party suffering by such breach shall be entitled to claim the incurred damages. 4.2. In case of any amendments to the Contract Registry Act and / or related legal requirements, Parties agree to amend this Agreement respectively, if needed.

Zveřejnění. Strany souhlasí, že v případě, že Xxxxxxx Smlouva Disclosure. The Parties hereby agree that in case bude muset být zveřejněna podle zákona č. 340/2015 Agreement must be disclosed pursuant to Act. No. Sb., . o zvláštních podmínkách účinnosti některých 340/2015 Coll. on Special Conditions of Effectiveness smluv, uveřejňování těchto smluv a o registru smluv of Certain Contracts, Publication thereof and the („zákon o registru smluv“) nebo podle dalších Contracts Register („Contract Registry Act“) or souvisejících regulačních opatření, provedou pursuant to other related legal regulations, they shall následující:  act as following: • Zdravotnické zařízení zveřejní Xxxxxxx s ohledem na postup uvedený v tomto odstavci;  • Důvěrné informace specifické pro klinické hodnocení a další důvěrné informace podle Článku 2 Přílohy A této Smlouvy nebudou zveřejněny;  Pro účely zveřejnění poskytne Zdravotnické zařízení Správci registru smluv kopii podepsané smlouvy ve formátu, který vyžaduje Zákon o registru smluv;  , který Zdravotnickému zařízení za tímto účelem připraví a poskytne Quintiles nejpozději v den podpisu této Smlouvy, a to ve strojově čitelném formátu v elektronické podobě zasláním na emailovou adresu XXXXXXXXXXXXXXXXXX Zdravotnické zařízení bude informovat společnosti společnost Quintiles o provedeném zveřejnění Smlouvy: (i) v registru smluv, je-li to možné, Zdravotnické zařízení uvede emailovou adresu společnosti Quintiles pro účel poskytnutí potvrzení ohledně zveřejnění Smlouvy; (ii) v případě, že možnost (i) výše nelze provést, Zdravotnické zařízení poskytne během 5 pracovních dnů od přijetí potvrzení o zveřejnění Smlouvy Xxxxxxx takové informace a příslušné důkazy společnosti Quintiles. Pro účely tohoto odstavce bude použita následující emailová adresa společnosti Institution shall disclose Agreement with respect to procedure indicated in this clause; Trial Specific Confidential Information and other confidential information according to the Article 2 of the Attachment A of this Agreement shall not be disclosed; For the purposes of disclosure, Institution shall provide to the Administrator of the Contract’s Register a copy of the signed Agreement in a format required by the Contract Registry Act which shall be created and provided to the Institution by Quintiles in a machine-readable format to the following e-mail address: XXXXXXXXXXXXXXXXXXI on the date of the execution hereof at the latest; Institution shall inform Quintiles of the performed disclosure of the Agreement: (i) in the Contract Register, if possible, Institution shall include Quintiles: XXXXXXXXXXXXXXXXXXXXXXXXXXXX  ’ email address for the purpose of provision ofthe confirmation about the disclosure of the Agreement; (ii) in case option (i) above could not be implemented, Institution shall within 5 business days as of receipt of the confirmation on the disclosure of the Agreement provide such information and the respective evidence to the Quintiles. For the purposes ofthis clause following email Smlouva o klinickém hodnocení / Clinical Trial Agreement Boehringer Ingelheim 1245.110 / YXA41297 Oblastní nemocnice Kladno, a.s., nemocnice Středočeského kraje / Verze/Version Redacted, 22052018 22 • Zdravotnické zařízení zveřejní Smlouva Smlouvu a rovněž poskytne potvrzení o zveřejnění společnosti Quintiles, jak je uvedeno výše v tomto odstavci během 2 měsíců 5 pracovních dnů od podpisu Smlouvy;  • V případě, že Smlouva Xxxxxxx bude zveřejněna jako porušení Zákona o registru smluv a/nebo této Smlouvy, Zdravotnické zařízení okamžitě, ale ne později než 2 dny od okamžiku, kdy se dozví o takovém porušení nebo od přijetí písemného požadavku od společnosti Quintiles odstraní porušení a zajistí, že zveřejnění je v souladu se Zákonem o registru smluv a rovněž s touto Smlouvou;  • V případě jakýchkoli dodatků zveřejněných informací informuje Zdravotnické zařízení o takových dodatcích okamžitě, ale ne později než během 2 pracovních dnů společnost Quintiles. Bez omezení uplatňování pravidel uvedených v tomto článku výše musí Zdravotnické zařízení v každém případě zveřejnit Smlouvu s ohledem na požadavky stanovené Zákonem o registru smluv, jakož i jakýchkoli jiných platných zákonů. Zdravotnické zařízení odškodní a zajistí ochranu společnosti Quintiles proti jakýmkoli případným škodám vzniklým z porušení Zákona o registru smluv nebo jiných platných zákonů ze strany Zdravotnického zařízení. 4.1. Řádné plnění tohoto odstavce je považováno za podstatně významné pro účely této Smlouvy; porušení jakýchkoliv povinností stanovených v tomto oddíle bude považováno za závažné porušení Smlouvy a kterákoli strana, která utrpí újmu takovým porušením má nárok na náhradu škod. 4.2. V případě jakýchkoli dodatků Zákona o registru smluv a/nebo souvisejících zákonných požadavků Strany souhlasí, že příslušným způsobem upraví tuto Smlouvu, bude-li třeba. 3) Ownership and Intellectual Property Rights Proprietary Information: All documents, data, know-how, formulas, protein and DNA sequences, and the Investigational Product, comparator, placebo provided to the Institution or Investigator for purposes of the Study are and shall remain the property of Sponsor and will be returned to Sponsor, Quintiles, or their respective designees upon request. Rights to Results: All data, information and materials developed or generated by Institution or Investigator as a result, or arising out, of the Study (“Study Results”) shall be the sole and exclusive property of Sponsor. Sponsor may use Study Results in connection with any of its research, development, marketing or promotional activities and in any other manner deemed appropriate to Sponsor's business interests. The Institution assigns all rights of Study Results obtained in the Study to Sponsor. Investigator shall notify Quintiles or Sponsor of the Study Results promptly, separately and in writing. Intellectual Property: (a) As used herein, “Intellectual Property” shall mean all rights, title and interest in and to the intellectual property and materials that are the subject of the Study or the Protocol, including, without limitation, all property rights in the Investigational Product and all data, technical information, inventions, discoveries, developments, improvements, enhancements, software, know-how, methods, techniques, formulae, data, processes and other proprietary ideas (whether or not patentable or registrable under patent, copyright or similar laws) and materials related to any product (including, without limitation, the Investigational Product), the Study or the Protocol, or otherwise derived, conceived, discovered, developed or reduced to practice as a direct or indirect result of the Institution’s performance of any services under or pursuant to this Agreement or during the course of or in connection with the Study whether generated or developed by the Institution, Quintiles or Sponsor or their respective agents, employees or contractors, either solely or jointly with others. Institution and Investigator acknowledge that all Intellectual Property shall be considered Confidential Information subject to Section 2. (b) All Intellectual Property shall be the sole and exclusive property of Sponsor. The Institution, including its employees or agents, shall not acquire any Intellectual Property or any other rights of any kind whatsoever with respect to the Investigational Product as a result of performance under this Agreement. The Institution hereby agrees to assign and herewith assigns to Sponsor all Intellectual Property and other rights resulting from the Study and the work under this Agreement. At all times, Sponsor shall have the exclusive right to use, assign, license or transfer ownership of any Intellectual Property without payment of any compensation to the Institution for such Intellectual Property. (c) The Institution agrees to promptly notify Sponsor of any such Intellectual Property invention, discovery or improvement, and to make all statements legally necessary to vest title in such invention, discovery or improvement in Sponsor. Sponsor shall have the sole and exclusive right to obtain, file and prosecute in its own name and at its expense, applications for patents on any information derived from Intellectual Property. Upon request and at the expense of Sponsor, the Institution shall assist Sponsor in securing and enforcing Sponsor’s rights in the Intellectual Property, including disclosure to Sponsor of all relevant or pertinent information and data with respect to such Intellectual Property and the execution of all oaths, assignments and other instruments necessary in order to apply for and obtain such rights and in order to assign and convey to Sponsor, its successors and assigns the sole and exclusive rights, title and interest in and to such Intellectual Property and any copyrights, patents or other intellectual property rights relating thereto. (d) Institution and Investigator warrant by the execution of this Agreement that they have not entered, and will not enter, into any contractual agreement or relationship which would in any way conflict with or compromise Sponsor’s rights to, any Study Results, inventions, discoveries, or technology arising out of or related to their performance thereunder. 4) Publicity and Publication. Sponsor shall have unrestricted publication rights for the Study Results and may give the data to third parties for publication. Quintiles and Sponsor recognize and acknowledge Institution’s interest in making publications relating to the Study in journals, at meetings or otherwise, for non-commercial purposes. Upon completion of the Study but not before the first publication of the consolidated Study results, or when data are adequate (in Sponsor’s reasonable judgement), the Institution has the right to prepare the data for publication. At least sixty (60) days prior to submitting or presenting a manuscript or other materials relating to the Study to a publisher, reviewer, or other outside persons, the Institution shall provide to Sponsor a copy of all such manuscripts and materials, and allow Sponsor sixty (60) days to review and comment on them. Unless Sponsor informs, the Institution and/or Investigator in writing during this sixty (60) day period that the proposed publication must be delayed in order to protect a patentable invention or changed a) to avoid disclosure of Confidential Information trade secrets or know-how, b) to ensure the accuracy of the presentation or publication, or c) to enable relevant supplementary information to be provided, Institution shall be free to publish the Study results Study results/data subject to the publication rules of this Section 4. In the event that a delay of the proposed publication is required, Institution shall withhold such submission for publication for an additional period agreed upon in good faith by the parties, however no longer than eighteen (18) months after submission of a respective patent application by Sponsor. The Institution agrees that if the Study is part of a multi-center study, any publication by the Institution of the results of the Study conducted at the Site shall not be made before the first multi-center publication; provided, however, that if no multi-center publication is made within one year from database lock, then the Institution may publish individually in accordance with this provision. For all publications relating to the Study or including any Study data, Sponsor, Site and Investigator agree to comply with the Good Publication Practise Guidelines (found at: xxxx://xxx.xxxxx.xxx) and all ethical standards concerning publications and authorship, including the rules of Good Scientific Practice, the guidelines for publications of clinical Study data as outlined e.g. by editors of the major medical journals as well as all ethical standards concerning publications and authorship, including the “Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals” as established by the International Committee of Medical Journal Editors (“ICMJE”) (found at xxxx://xxx.xxxxx.xxx). Authorship of any publications relating to the Study shall be determined by mutual agreement. Sponsor has the right to name co-authors. A representative of the Sponsor substantially involved in the implementation of the Study will serve as co-author in the primary full publication of the study, unless otherwise agreed. Institution shall oblige all its employees and other third parties participating in the conduct of the Study to comply with the above mentioned obligations. No party hereto shall use any other party’s name, or Sponsor’s name trademarks, logos, physical likeness, employee name, owner symbol, or other image, in connection with any advertising, publication or promotion as well as in any other publications, applications or forms without prior written permission, except that the Sponsor and Quintiles may use the Institution’s and Investigator’s name in Study publications and communications, including clinical trial websites and Study newsletters, and as stated in Section 4 of the Agreement. Furthermore, Sponsor, may use the name of Institution and/or Investigator in any publication, applications or forms, or other materials submitted to any regulatory authority and/or other disclosures required by Applicable Law such as disclosures in clinical trial registries. Designation of Business Secret. Parties hereby acknowledge and agree that Attachment B, the minimum enrollment goal, expected number of Study subjects enrolled and the expected duration of the Study, Investigator’s Brochure, Insurance Contract on Clinical Trial Insurance, Clinical Trial Protocol and personal data of the individuals, (further stated as „Trial Specific Confidential Information“), are deemed as information significant within the meaning of statutory definition of business secret (Section 504 of Act No. 89/2012 Coll., the Civil Code), as universal access to such information may have a substantial impact on economic results and market position of the Sponsor and members of the Sponsor’s group in other EU Member States. Trial Specific Confidential Information are either part of the text of the main Agreement or individual attachments to this Agreement. Institution and Investigator acknowledge that they also deem Trial Specific Confidential Information significant within the meaning of statutory definition of business secret (Section 504 of Act No. 89/2012 Coll., the Civil Code) and undertake to keep such information confidential in accordance with Section 2) hereof. Disclosure. The Parties hereby agree that in case Agreement must be disclosed pursuant to Act. No. 340/2015 Coll. on Special Conditions of Effectiveness of Certain Contracts, Publication thereof and the Contracts Register („Contract Registry Act“) or pursuant to other related legal regulations, they shall act as following:  Institution shall disclose Agreement with respect to procedure indicated in this clause;  Trial Specific Confidential Information and other confidential information according to the Article 2 of this Agreement shall not be disclosed;  For the purposes of disclosure, Institution shall provide to the Administrator of the Contract’s Register a copy of the signed Agreement in a format required by the Contract Registry Act;  Institution shall inform Quintiles of the performed disclosure of the Agreement: (i) in the Contract Register, if possible, Institution shall include Quintiles’ email address for the purpose of provision of the confirmation about the disclosure of the Agreement; (ii) in case option (i) above could not be implemented, Institution shall within 5 business days as of receipt of the confirmation on the disclosure of the Agreement provide such information and the respective evidence to the Quintiles. For the purposes of this clause following email address of Quintiles shall be used: XXXXXXXXXXXXXXXXXXXXXXXXXXXX  Institution shall disclose Agreement as well as provide confirmation about the disclosure to Quintiles as indicated above in this clause within 2 months as of signing of the Agreement;  In case the Agreement will be disclosed in breach with the Contract Registry Act and / or this Agreement, the Institution shall immediately but not later than within 2 days as of becoming aware of such breach or as of receipt of the written request from the Quintiles eliminate the breach and ensure that the disclosure meets Contract Registry Act as well as this Agreement;  In case any amendments would be performed to the disclosed information, Institution shall immediately but not later than within 2 business days inform Quintiles of such amendments. Without limiting application of the rules indicated in this clause above, Institution shall at all events disclose Agreement with respect to requirements established by the Contract Registry Act as well as any other applicable laws. Institution shall indemnify and hold Quintiles harmless for any damage resulting of a breach of the Contract Registry Act or other applicable laws by the Institution. 4.1. Proper performance of this clause is considered of significant importance for the purposes of this Agreement; breach of any obligations stipulated in this section will be considered as serious breach of the Agreement and any Party suffering by such breach shall be entitled to claim the incurred damages. 4.2. In case of any amendments to the Contract Registry Act and / or related legal requirements, Parties agree to amend this Agreement respectively, if needed.