Common use of Authorization to Use and Disclose Health Information Clause in Contracts

Authorization to Use and Disclose Health Information. Institution and Principal Investigator will obtain a written privacy authorization, complying with Czech Republic data protection laws and Applicable Law, for each Trial Subject which will enable Institution and Principal Investigator to provide Sponsor and other persons and entities designated by Sponsor access to completed case report forms (“CRFs”), source documents and all other information required by the Protocol. Sponsor, though not a covered entity, recognizes that, pursuant to this Agreement, it has the responsibility to protect all individually identifiable patient information and to restrict the use of such information to those persons and entities, including consultants, contractors, subcontractors and agents, who must have access to such information in order to fulfill their assigned duties with respect to the Trial. Such use also will be restricted to those permitted in the authorization forms and neither Sponsor nor any party to whom Sponsor may disclose individually identifiable health information may use such information to recruit research subjects to additional studies, to advertise additional studies or products, or to perform marketing or marketing research. If such an authorization is separate from the ICF, Institution and Principal Investigator will only use such authorization that is approved by Sponsor, IEC (if applicable) and regulatory authority (if applicable).

Authorization to Use and Disclose Health Information. Institution and Principal Investigator will obtain a written privacy authorization, complying with Czech Republic data protection laws and Applicable Law, for each Trial Subject which will enable Institution and Principal Investigator to provide Sponsor and other persons and entities designated by Sponsor access to completed case report forms (“CRFs”), source documents and all other information required by the Protocol. Sponsor, though not a covered entity, recognizes that, pursuant to this Agreement, it has the responsibility to protect all individually identifiable patient information and to restrict the use of such information to those persons and entities, including consultants, contractors, subcontractors and agents, who must have access to such information in order to fulfill their assigned duties with respect to the Trial. Such use also will be restricted to those permitted in the authorization forms and neither Sponsor nor any party to whom Sponsor may disclose individually identifiable health information may use such information to recruit research subjects to additional studies, to advertise additional studies or products, or to perform marketing or marketing research. If such an authorization is separate from the ICF, Institution and Principal Investigator will only use such authorization that is approved by Sponsor, IEC (if applicable) and regulatory authority (if applicable). 11.

Authorization to Use and Disclose Health Information. Institution and Principal Investigator will obtain within the ICF a written privacy authorization, complying with Czech Republic data protection laws and all Applicable Law, for each Trial Subject which will enable Institution and Principal Investigator to provide Sponsor and other persons and entities designated by Sponsor access to with completed case report forms (“CRFs”), source documents and all other information required by the Protocol. Sponsor, though not a covered entity, recognizes that, pursuant to this Agreement, it has the responsibility to protect all individually identifiable patient information and to restrict the use of such information to those persons and entities, including consultants, contractors, subcontractors and agents, who must have access to such information in order to fulfill their assigned duties with respect to the Trial. Such use also will be restricted to those permitted in the authorization forms and neither Sponsor nor any party to whom Sponsor may disclose individually identifiable health information may use such information to recruit research subjects to additional studies, to advertise additional studies or products, or to perform marketing or marketing research. If such an authorization is separate from the ICF, Institution and Principal Investigator will only use such authorization that is approved by Sponsor, IEC (if applicable) and regulatory authority (if applicable).10.1

Authorization to Use and Disclose Health Information. Institution Provider and Principal Investigator will obtain within an ICF a written privacy authorization, complying with Czech Republic data protection laws and all Applicable Law, for each Trial Subject which will enable Institution Provider and Principal Investigator to provide Sponsor and other persons and entities designated by Sponsor access to with completed case report forms (“CRFs”), source documents and all other information required by the Protocol. Sponsor, though not a covered entity, recognizes that, pursuant to this Agreement, it has the responsibility to protect all individually identifiable patient information and to restrict the use of such information to those persons and entities, including consultants, contractors, subcontractors and agents, who must have access to such information in order to fulfill their assigned duties with respect to the Trial. Such use also will be restricted to those permitted in the authorization forms and neither Sponsor nor any party to whom Sponsor may disclose individually identifiable health information may use such information to recruit research subjects to additional studies, to advertise additional studies or products, or to perform marketing or marketing research. If such an authorization is separate from the ICF, Institution Provider and Principal Investigator will only use such provide Sponsor or INC Research an opportunity to review and approve the content of the authorization that (including any revisions made during the course of the Trial) before it is approved by Sponsor, IEC (if applicable) and regulatory authority (if applicable)used. 11.

Authorization to Use and Disclose Health Information. Institution and Principal Investigator will obtain a written privacy authorization, complying with Czech Republic data protection laws Applicable Laws and Applicable LawRegulations, for each Trial Subject which will enable Institution and Principal Investigator to provide Sponsor and other persons and entities designated by Sponsor access to completed case report forms (“CRFs”), source documents and all other information required by the Protocol. Sponsor is responsible for the wording of the form. Sponsor, though not a covered entity, recognizes that, pursuant to this Agreement, it has the responsibility to protect all individually identifiable patient information and to restrict the use of such information to those persons and entities, including consultants, contractors, subcontractors and agents, who must have access to such information in order to fulfill their assigned duties with respect to the Trial. Such use also will be restricted to those permitted in the authorization forms and neither Sponsor nor any party to whom Sponsor may disclose individually identifiable health information may use such information to recruit research subjects to additional studies, to advertise additional studies or products, or to perform marketing or marketing research. If such an authorization is separate from the ICF, Institution and Principal Investigator will only use such authorization that is approved by Sponsor, IEC (if applicable) and regulatory authority (if applicable). Sponsor undertakes to provide to Principal Investigator with a sample of Informed Consent that includes all the above requirements.