Common use of Insurance and Indemnification Clause in Contracts

Insurance and Indemnification. In accordance with Applicable Laws, the SPONSOR shall be liable, even without fault, for any damage incurred by a Study Participant or, in the case of death, his rightful claimants, that arises either in direct or indirect connection with the Study and shall provide compensation therefore. The SPONSOR shall enter into an insurance contract in accordance with Applicable Laws. Each Party, shall indemnify and hold harmless the other, its agents and employees (collectively the “Other Party’s Indemnitees”) from any and all duly evidenced liabilities, claims, actions, or suits to the extent caused by its negligence or wrongful acts or omissions; or the negligence or wrongful acts or omissions of its agents or employees pertaining to the activities to be carried out pursuant to the obligations under this Agreement. Each Party shall promptly notify the other in writing of any such complaint, claim or injury relating to any loss subject to this indemnification. Neither Party shall indemnify and hold harmless the Other Party’s Indemnitees from liabilities arising out of negligence or wrongful acts or omissions of such Other Party’s Indemnitees. Without prejudice to SPONSOR’s no-fault liability towards Study Participants, the SPONSOR recognizes the need for the INVESTIGATOR to provide, at SPONSOR’s expense reasonable and necessary care for Study Participants involved in the Study with any adverse reaction in direct or indirect connection with the Study. In case of gross negligence or willful misconduct of the INVESTIGATOR and/or INSTITUTION, the SPONSOR may seek recourse against the INVESTIGATOR and/or the INSTITUTION. Except in case of gross negligence or wilful misconduct, [including breach of Sponsor Owned Inventions under Article 6.4.3, […][…] ], or where such limitation would be prohibited by mandatory provisions of law, the INSTITUTION’s total liability and indemnification obligation under this Agreement to the SPONSOR [and CRO jointly] under any and all circumstances for direct damages jointly shall under any and all circumstances not exceed (a) for damages covered under the civil liability insurance policy of the INSTITUTION in accordance with Article 7.6, the effective coverage under such insurance policy, and (b) for damages not covered under the civil liability insurance policy of the INSTITUTION (i) per occurrence an amount corresponding to the aggregated fees (excluding pass through costs) paid or/to be paid by the SPONSOR (and/or CRO) to the INSTITUTION for the Study under this Agreement; and (ii) in aggregate, an amount corresponding to [XX times] the aggregated fees paid/or to be paid by the SPONSOR (and/or CRO) to the INSTITUTION for the Study under this Agreement [or such other fixed amount as may be agreed upon by the Parties upon a case by case basis]. In any case abovementioned the INSTITUTION’s total liability and indemnification obligation under this Agreement to the SPONSOR [and CRO jointly] shall terminate upon the 10th (tenth) anniversary [or such other time as may be agreed upon by the Parties upon a case by case basis] of the end of the Study at the INSTITUTION in accordance with the Protocol. Notwithstanding anything to the contrary herein, [and except in case of gross negligence and/or wilful misconduct, [including breach of Sponsor Owned Inventions under Article 6.4.3, [...]], or where such limitation would be prohibited by mandatory provisions of law, in no event shall either Party be liable as between the Parties to the other for any indirect or consequential damages (including lost profits) to the extent not covered under the civil liability insurance policy arising out of the subject matter or performance of this Agreement. The INSTITUTION declares that it has a mandatory civil liability insurance policy in accordance with Applicable Laws which notably covers the INSTITUTION, its employees including the INVESTIGATOR and undertakes to maintain such insurance policy throughout the term of this Agreement and provides upon request of the SPONSOR any updated insurance certificate. The SPONSOR declares and warrants that it has a civil liability insurance policy which notably covers the SPONSOR and its employees and undertakes to maintain such insurance policy throughout the term of this Agreement and provides upon request of the INSTITUTION any updated insurance certificate. All Parties shall promptly inform each other of any claims or imminent claims relating to the conduct of the Study. No admission or settlements in respect of the alleged liability of the other Party shall be made without the prior written approval of that Party (such consent not to be unreasonably withheld). For the avoidance of doubt, each Party shall be entitled to seek own counsel for any claims against itself or its employees. Notwithstanding the provisions set out in Article 7.4, nothing in this Article 7 shall operate so as to restrict or exclude the liability of any Party vis-à-vis the Study Participants in relation to their death or personal injury caused by the negligence of that Party or its agents or employees or to restrict or exclude any other liability of a Party which cannot be so restricted or excluded in law. INSPECTION AND AUDIT Upon request by any authorised officer or employee of any relevant regulatory agency, or other government authority, the INSTITUTION and the INVESTIGATOR are entitled and obliged to permit such officers or employees, at reasonable times, to have access to and inspect and verify any data records and reports in the INSTITUTION's and/or the INVESTIGATOR's possession, custody or control relating to the Study and shall submit such data records or reports to the said regulatory agency upon its request. In the case of a GCP inspection, the presence of a representative of SPONSOR is required unless otherwise stated by the SPONSOR. Unless prohibited by law or court order, the INSTITUTION and the INVESTIGATOR shall immediately inform the SPONSOR of any such inspection so as to allow the SPONSOR to be present to the inspection if he elects to be present, to allow the SPONSOR to prospectively review and comment on INSTITUTION’s responses, and send to the SPONSOR a copy of any such inspection report. The SPONSOR shall be entitled to audit or have audited (i) the INSTITUTION's fulfilment of its obligations hereunder (such as, but not limited to invoiced costs and expenses), and/or (ii) the performance of the Study by the INVESTIGATOR. The SPONSOR shall inform the INSTITUTION within a reasonable timeline compatible with the clinical activity of the INVESTIGATOR and INVESTIGATOR’s team. Upon request of SPONSOR, INSTITUTION and/or INVESTIGATOR shall provide to SPONSOR copies of all materials, reports, correspondence, statements, forms and records which INSTITUTION and/or INVESTIGATOR receives, obtains or generates pursuant to any inspection in connection with the Study, or in connection with any matter that may affect INSTITUTION’s OR INVESTIGATOR’s performance of the Study, unless prohibited by law or court order and in line with INSTITUTION’s internal procedures.

Insurance and Indemnification. In accordance with Applicable Laws, the SPONSOR shall be liableassume, even without fault, for the responsibility of any damage incurred by a Study Participant or, in the case of death, his rightful claimants, that arises either in direct or indirect connection with the Study experiments and shall provide compensation therefore. The SPONSOR shall enter into an insurance contract in accordance with Applicable Laws. Each Party, shall indemnify and hold harmless the other, its agents and employees (collectively the “Other Party’s Indemnitees”) from any and all duly evidenced liabilities, claims, actions, or suits to the extent caused by its negligence or wrongful acts or omissions; or the negligence or wrongful acts or omissions of its agents or employees pertaining to the activities to be carried out pursuant to the obligations under this Agreement. Each Party shall promptly notify the other in writing of any such complaint, claim or injury relating to any loss subject to this indemnification. Neither Party shall indemnify and hold harmless the Other Party’s Indemnitees from liabilities arising out of negligence or wrongful acts or omissions of such Other Party’s Indemnitees. Without prejudice to SPONSOR’s no-fault liability towards Study ParticipantsParticipant, the SPONSOR recognizes the need for the INVESTIGATOR to provide, at SPONSOR’s expense reasonable and necessary care for Study Participants involved in the Study with any adverse reaction in direct or indirect connection with the Study. In case of gross negligence or willful misconduct of the INVESTIGATOR and/or INSTITUTION, the SPONSOR may seek recourse against the INVESTIGATOR and/or the INSTITUTION. Except in case of gross negligence or wilful misconduct, [including breach of Sponsor Owned Inventions SPONSOR IP under Article 6.4.3., […][…] ], or where such limitation would be prohibited by mandatory provisions of law, the INSTITUTION’s total liability and indemnification obligation under this Agreement to the SPONSOR [and CRO jointly] under any and all circumstances for direct damages jointly shall under any and all circumstances not exceed (a) for damages covered under the civil liability insurance policy of the INSTITUTION in accordance with Article article 7.6, the effective coverage under such insurance policy, and (b) for damages not covered under the civil liability insurance policy of the INSTITUTION (i) per occurrence an amount corresponding to the aggregated fees (excluding pass through costs) paid or/to be paid by the SPONSOR (and/or CRO) to the INSTITUTION for the Study under this Agreement; and and/or (ii) in aggregate, an amount corresponding to [XX times] the aggregated fees paid/or to be paid by the SPONSOR (and/or CRO) to the INSTITUTION for the Study under this Agreement [or such other fixed amount as may be agreed upon by the Parties upon a case by case basis]. In any case abovementioned the INSTITUTION’s total liability and indemnification obligation under this Agreement to the SPONSOR [and CRO jointly] shall terminate upon the 10th (tenth) anniversary [or such other time as may be agreed upon by the Parties upon a case by case basis] of the end date of the Study at the INSTITUTION in accordance with the Protocol. Notwithstanding anything to the contrary herein, [and except in case of gross negligence and/or wilful misconduct, [including breach of Sponsor Owned Inventions SPONSOR IP under Article 6.4.3, [...]], or where such limitation would be prohibited by mandatory provisions of law, in no event shall either Party be liable as between the Parties to the other for any indirect or consequential damages (including lost profits) to the extent not covered under the civil liability insurance policy arising out of the subject matter or performance of this Agreement. The INSTITUTION declares that it has a mandatory civil liability insurance policy in accordance with Applicable Laws which notably covers the INSTITUTION, its employees including and the INVESTIGATOR (if not an employee) and undertakes to maintain such insurance policy throughout the term of this Agreement and provides upon request of the SPONSOR any updated insurance certificate. The SPONSOR declares and warrants that it has a civil liability insurance policy which notably covers the SPONSOR and its employees and undertakes to maintain such insurance policy throughout the term of this Agreement and provides upon request of the INSTITUTION any updated insurance certificate. Neither Party shall indemnify and hold harmless the Other Party’s Indemnitees from liabilities arising out of gross negligence or wrongful acts or omissions of such Other Party’s Indemnitees. All Parties shall promptly inform each other of any claims or imminent claims relating to the conduct of the Study. No admission or settlements in respect of the alleged liability of the other Party shall be made without the prior written approval of that Party (such consent not to the other Party. If one of the Parties admits liability, it shall be unreasonably withheld)given full conduct and control of any defense proceedings and negotiations concerning claims against the liable party. For the avoidance of doubt, each Party shall be entitled to seek own counsel for any claims against itself or its employees. Notwithstanding the provisions set out in Article 7.4, nothing in this Article 7 shall operate so as to restrict or exclude the liability of any Party vis-à-vis the Study Participants in relation to their death or personal injury caused by the negligence of that Party or its agents or employees or to restrict or exclude any other liability of a Party which cannot be so restricted or excluded in law. INSPECTION AND AUDIT Upon request by any authorised officer or employee of any relevant regulatory agency, or other government authority, the INSTITUTION and the INVESTIGATOR are entitled and obliged to permit such officers or employees, at reasonable times, to have access to and inspect and verify any data records and reports in the INSTITUTION's and/or the INVESTIGATOR's possession, custody or control relating to the Study and shall submit such data records or reports to the said regulatory agency upon its request. In the case of a GCP inspection, the presence of a representative of the SPONSOR is required unless otherwise stated by the SPONSOR. Unless prohibited by law or court order, the INSTITUTION and the INVESTIGATOR shall immediately inform the SPONSOR of any such inspection so as to allow the SPONSOR to be present to the inspection if he elects to be present, to allow the SPONSOR to prospectively review and comment on INSTITUTION’s responses, and send to the SPONSOR a copy of any such inspection reportreport . The SPONSOR shall be entitled at any time to audit or have audited (i) the INSTITUTION's fulfilment of its obligations hereunder (such as, but not limited to invoiced costs and expenses), and/or (ii) the performance of the Study by the INVESTIGATOR. The SPONSOR shall inform the INSTITUTION within a reasonable timeline compatible with the clinical activity of the INVESTIGATOR and INVESTIGATOR’s team. Upon request of SPONSOR, INSTITUTION and/or INVESTIGATOR shall provide to SPONSOR copies of all materials, reports, correspondence, statements, forms and records which INSTITUTION and/or INVESTIGATOR receives, obtains or generates pursuant to any inspection in connection with the Study, or in connection with any matter that may affect INSTITUTION’s OR INVESTIGATOR’s performance of the Study, unless prohibited by law or court order and in line with INSTITUTION’s internal procedures.

Insurance and Indemnification. In accordance with Applicable Lawsthe Belgian Law relating to experiments on the human person dated 07 May 2004, the SPONSOR shall be liableassume, even without fault, for the responsibility of any damage incurred by a Study Participant study patient or, in the case of death, his rightful claimants, claimants sustained that arises either in direct or indirect connection with the Study experiments and shall provide compensation therefore. The SPONSOR shall enter into an insurance contract in accordance with Applicable Lawsarticle 29 of the Belgian Law relating to experiments on the human person dated 07 May 2004. Each PartyThe INSTITUTION or INVESTIGATOR, respectively, shall indemnify indemnify, defend and hold harmless the otherSPONSOR, its agents and employees (collectively the “Other Party’s SPONSOR Indemnitees”) from any and all duly evidenced liabilities, claims, actions, or suits to the extent caused by its negligence or wrongful acts or omissions; or the resulting from negligence or wrongful acts or omissions of its the INSTITUTION or INVESTIGATOR, their respective agents or employees (collectively the “INSTITUTION or INVESTIGATOR Indemnitees”) pertaining to the activities to be carried out pursuant to the obligations under this Agreement. Each Party This indemnification obligation shall continue in effect after the date of expiration or earlier termination of this Agreement for a period of ten (10) years after which this obligation shall cease and expire. The SPONSOR shall promptly notify the other INSTITUTION or INVESTIGATOR in writing of any such complaint, claim or injury within thirty (30) days after a SPONSOR Indemnitee’s receipt of notice of any complaint, claim or injury relating to any loss subject to this indemnification. Neither Party shall indemnify The INSTITUTION declares and hold harmless the Other Party’s Indemnitees from liabilities arising out of negligence or wrongful acts or omissions of such Other Party’s Indemnitees. Without prejudice to SPONSOR’s no-fault liability towards Study Participants, the SPONSOR recognizes the need for the INVESTIGATOR to provide, at SPONSOR’s expense reasonable and necessary care for Study Participants involved in the Study with any adverse reaction in direct or indirect connection with the Study. In case of gross negligence or willful misconduct of the INVESTIGATOR and/or INSTITUTION, the SPONSOR may seek recourse against the INVESTIGATOR and/or the INSTITUTION. Except in case of gross negligence or wilful misconduct, [including breach of Sponsor Owned Inventions under Article 6.4.3, […][…] ], or where such limitation would be prohibited by mandatory provisions of law, the INSTITUTION’s total liability and indemnification obligation under this Agreement to the SPONSOR [and CRO jointly] under any and all circumstances for direct damages jointly shall under any and all circumstances not exceed (a) for damages covered under the warrants that it has a civil liability insurance policy of the INSTITUTION in accordance with Article 7.6, the effective coverage under such insurance policy, and (b) for damages not covered under the civil liability insurance policy of the INSTITUTION (i) per occurrence an amount corresponding to the aggregated fees (excluding pass through costs) paid or/to be paid by the SPONSOR (and/or CRO) to the INSTITUTION for the Study under this Agreement; and (ii) in aggregate, an amount corresponding to [XX times] the aggregated fees paid/or to be paid by the SPONSOR (and/or CRO) to the INSTITUTION for the Study under this Agreement [or such other fixed amount as may be agreed upon by the Parties upon a case by case basis]. In any case abovementioned the INSTITUTION’s total liability and indemnification obligation under this Agreement to the SPONSOR [and CRO jointly] shall terminate upon the 10th (tenth) anniversary [or such other time as may be agreed upon by the Parties upon a case by case basis] of the end of the Study at the INSTITUTION in accordance with the Protocol. Notwithstanding anything to the contrary herein, [and except in case of gross negligence and/or wilful misconduct, [including breach of Sponsor Owned Inventions under Article 6.4.3, [...]], or where such limitation would be prohibited by mandatory provisions of law, in no event shall either Party be liable as between the Parties to the other for any indirect or consequential damages (including lost profits) to the extent not covered under the civil liability insurance policy arising out of the subject matter or performance of this Agreement. The INSTITUTION declares that it has a mandatory civil liability insurance policy in accordance with Applicable Laws which notably covers the INSTITUTION, its employees including the INVESTIGATOR and INSTITUTION’s employees and undertakes to maintain such insurance policy throughout the term of this Agreement and provides upon request of the SPONSOR any updated insurance certificate. The SPONSOR declares Neither the INSTITUTION nor INVESTIGATOR shall indemnify, defend and warrants that it has a civil liability insurance policy which notably covers hold harmless the SPONSOR and its employees and undertakes to maintain such insurance policy throughout the term Indemnitees from liabilities arising out of this Agreement and provides upon request negligence or wrongful acts or omissions of the SPONSOR Indemnitees. The INSTITUTION or INVESTIGATOR or their respective Indemnitees shall not make any updated insurance certificate. All Parties shall promptly inform each other of any claims or imminent claims statements relating to any claim or proceedings and shall fully rely on the conduct SPONSOR to handle the claim or proceedings. SPONSOR shall notify INSTITUTION and INVESTIGATOR of the Study. No admission progress and shall not make any statements nor settlements relating to any claim or settlements in respect of the alleged liability of the other Party shall be made proceeding that make a reference to INSTITUTION or INVESTIGATOR without the prior written approval of that Party (INSTITUTION or INVESTIGATOR, such consent approval not to be unreasonably withheld). For the avoidance of doubt, each Party shall be entitled to seek own counsel for any claims against itself or its employees. Notwithstanding the provisions set out in Article 7.4, nothing in this Article 7 shall operate so as to restrict or exclude the liability of any Party vis-à-vis the Study Participants in relation to their death or personal injury caused by the negligence of that Party or its agents or employees or to restrict or exclude any other liability of a Party which cannot be so restricted or excluded in law. INSPECTION AND AUDIT Upon request by any authorised officer or employee of any relevant regulatory agency, or other government authority, the INSTITUTION and the INVESTIGATOR are entitled and obliged to permit such officers or employees, at reasonable times, to have access to and inspect and verify any data records and reports in the INSTITUTION's and/or the INVESTIGATOR's possession, custody or control relating to the Study and shall submit such data records or reports to the said regulatory agency upon its request. In the case of a GCP inspection, the presence of a representative of SPONSOR is required unless otherwise stated by the SPONSOR. Unless prohibited by law or court order, the INSTITUTION and the INVESTIGATOR shall immediately inform the SPONSOR of any such inspection so as to allow the SPONSOR to be present to the inspection if he elects to be present, to allow the SPONSOR to prospectively review and comment on INSTITUTION’s responses, and send to the SPONSOR a copy of any such inspection report. The SPONSOR shall be entitled to audit or have audited (i) the INSTITUTION's fulfilment of its obligations hereunder (such as, but not limited to invoiced costs and expenses), and/or (ii) the performance of the Study by the INVESTIGATOR. The SPONSOR shall inform the INSTITUTION within a reasonable timeline compatible with the clinical activity of the INVESTIGATOR and INVESTIGATOR’s team. Upon request of SPONSOR, INSTITUTION and/or INVESTIGATOR shall provide to SPONSOR copies of all materials, reports, correspondence, statements, forms and records which INSTITUTION and/or INVESTIGATOR receives, obtains or generates pursuant to any inspection in connection with the Study, or in connection with any matter that may affect INSTITUTION’s OR INVESTIGATOR’s performance of the Study, unless prohibited by law or court order and in line with INSTITUTION’s internal procedures.

Insurance and Indemnification. In accordance with Applicable Laws, the SPONSOR shall be liable, even without fault, for any damage incurred by a Study Participant or, in the case of death, his rightful claimants, that arises either in direct or indirect connection with the Study and shall provide compensation therefore. The SPONSOR shall enter into an insurance contract in accordance with Applicable Laws. Each Party, shall indemnify and hold harmless the other, its agents and employees (collectively the “Other Party’s Indemnitees”) from any and all duly evidenced liabilities, claims, actions, or suits to the extent caused by its negligence or wrongful acts or omissions; or the negligence or wrongful acts or omissions of its agents or employees pertaining to the activities to be carried out pursuant to the obligations under this Agreementthe applicable Work Order. Each Party shall promptly notify the other in writing of any such complaint, claim or injury relating to any loss subject to this indemnification. Neither Party shall indemnify and hold harmless the Other Party’s Indemnitees from liabilities arising out of negligence or wrongful acts or omissions of such Other Party’s Indemnitees. Without prejudice to the SPONSOR’s no-fault liability towards Study Participants, the SPONSOR recognizes the need for the INVESTIGATOR to provide, at the SPONSOR’s expense reasonable and necessary care for Study Participants involved in the Study with any adverse reaction in direct or indirect connection with the Study. In case of gross negligence or willful wilful misconduct of the INVESTIGATOR and/or the INSTITUTION, the SPONSOR may seek recourse against the INVESTIGATOR and/or the INSTITUTION. Except in case of gross negligence or wilful misconduct, [misconduct including breach of Sponsor Owned Inventions under Article 6.4.3, […][…] ]6.4.2, or where such limitation would be prohibited by mandatory provisions of law, the INSTITUTION’s total liability and indemnification obligation under this Agreement the applicable Work Order to the SPONSOR [and CRO jointly] under any and all circumstances for direct damages jointly shall under any and all circumstances not exceed (a) for damages covered under the civil liability insurance policy of the INSTITUTION in accordance with Article 7.6, the effective coverage under such insurance policy, ; and (b) for damages not covered under the civil liability insurance policy of the INSTITUTION (i) per occurrence an amount corresponding to the aggregated fees (excluding pass through costs) paid or/to be paid by the SPONSOR (and/or CRO) to the INSTITUTION for the Study under this Agreementthe applicable Work Order; and (ii) in aggregate, an amount corresponding to [XX times] 2 times the aggregated fees paid/or to be paid by the SPONSOR (and/or CRO) to the INSTITUTION for the Study under this Agreement [or such other fixed amount as may be agreed upon by the Parties upon a case by case basis]applicable Work Order. In any case abovementioned the INSTITUTION’s total liability and indemnification obligation under this Agreement the applicable Work Order to the SPONSOR [and CRO jointly] shall terminate upon the 10th (tenth) anniversary [or such other time as may be agreed upon by the Parties upon a case by case basis] of the end of the Study at the INSTITUTION in accordance with the Protocol. Notwithstanding anything to the contrary herein, [and except in case of gross negligence and/or wilful misconduct, [including breach of Sponsor Owned Inventions under Article 6.4.3, [...]]6.4.2, or where such limitation would be prohibited by mandatory provisions of law, in no event shall either Party be liable as between the Parties to the other for any indirect or consequential damages (including lost profits) to the extent not covered under the civil liability insurance policy arising out of the subject matter or performance of this Agreementthe applicable Work Order. The INSTITUTION declares that it has a mandatory civil liability insurance policy in accordance with Applicable Laws which notably covers the INSTITUTION, its employees including the INVESTIGATOR and undertakes to maintain such insurance policy throughout the term of this Agreement the applicable Work Order and provides upon request of the SPONSOR any updated insurance certificate. The SPONSOR declares and warrants that it has a civil liability insurance policy which notably covers the SPONSOR and its employees and undertakes to maintain such insurance policy throughout the term of this Agreement the applicable Work Order and provides upon request of the INSTITUTION any updated insurance certificate. All Parties shall promptly inform each other of any claims or imminent claims relating to the conduct of the Study. No admission or settlements in respect of the alleged liability of the other Party shall be made without the prior written approval of that Party (such consent not to be unreasonably withheld). For the avoidance of doubt, each Party shall be entitled to seek own counsel for any claims against itself or its employees. Notwithstanding the provisions set out in Article 7.4, nothing in this Article 7 shall operate so as to restrict or exclude the liability of any Party vis-à-vis the Study Participants in relation to their death or personal injury caused by the negligence of that Party or its agents or employees or to restrict or exclude any other liability of a Party which cannot be so restricted or excluded in law. INSPECTION AND AUDIT Upon request by any authorised officer or employee of any relevant regulatory agency, or other government competent authority, the INSTITUTION and the INVESTIGATOR are entitled and obliged to permit such officers or employees, at reasonable times, to have access to and inspect and verify any data records and reports in the INSTITUTION's and/or the INVESTIGATOR's possession, custody or control relating to the Study and shall submit such data records or reports to the said regulatory agency competent authority upon its request. In the case of a GCP inspection, the presence of a representative of SPONSOR is required unless otherwise stated by the SPONSOR. Unless prohibited by law or court order, the INSTITUTION and the INVESTIGATOR shall immediately inform the SPONSOR of any such inspection so as to allow the SPONSOR to be present to the inspection if he elects to be present, to allow the SPONSOR to prospectively review and comment on the INSTITUTION’s responses, and send to the SPONSOR a copy of any such inspection report. The SPONSOR shall be entitled to audit or have audited (i) the INSTITUTION's ’s fulfilment of its obligations hereunder (such as, but not limited to invoiced costs and expenses), and/or (ii) the performance of the Study by the INVESTIGATOR. The SPONSOR shall inform the INSTITUTION within a reasonable timeline compatible with the clinical activity of the INVESTIGATOR and the INVESTIGATOR’s team. Upon request of the SPONSOR, the INSTITUTION and/or the INVESTIGATOR shall provide to the SPONSOR copies of all materials, reports, correspondence, statements, forms and records which the INSTITUTION and/or the INVESTIGATOR receives, obtains or generates pursuant to any inspection in connection with the Study, or in connection with any matter that may affect the INSTITUTION’s OR or the INVESTIGATOR’s performance of the Study, unless prohibited by law or court order and in line with the INSTITUTION’s internal procedures.

Insurance and Indemnification. In accordance with Applicable LawsResponding Agency and Requesting Agency are authorized self-insured or partially self-insured public entities for purposes of Professional Liability, the SPONSOR shall be liableGeneral Liability, even without faultAutomobile Liability and Worker's Compensation and warrant that through their respective programs of self-insurance and insurance, for any damage incurred by a Study Participant or, in the case of death, his rightful claimants, that arises either in direct they have adequate coverage or indirect connection with the Study and shall provide compensation therefore. The SPONSOR shall enter into an insurance contract in accordance with Applicable Laws. Each Party, shall indemnify and hold harmless the other, its agents and employees (collectively the “Other Party’s Indemnitees”) from any and all duly evidenced liabilities, claims, actions, or suits resources to the extent caused by its negligence or wrongful acts or omissions; or the negligence or wrongful acts or omissions of its agents or employees pertaining to the activities to be carried out pursuant to the obligations under this Agreement. Each Party shall promptly notify the other in writing of any such complaint, claim or injury relating to any loss subject to this indemnification. Neither Party shall indemnify and hold harmless the Other Party’s Indemnitees from protect against liabilities arising out of negligence or wrongful acts or omissions of such Other Party’s Indemnitees. Without prejudice to SPONSOR’s no-fault liability towards Study Participants, the SPONSOR recognizes the need for the INVESTIGATOR to provide, at SPONSOR’s expense reasonable and necessary care for Study Participants involved in the Study with any adverse reaction in direct or indirect connection with the Study. In case of gross negligence or willful misconduct performance of the INVESTIGATOR and/or INSTITUTIONterms, the SPONSOR may seek recourse against the INVESTIGATOR and/or the INSTITUTION. Except in case of gross negligence conditions or wilful misconduct, [including breach of Sponsor Owned Inventions under Article 6.4.3, […][…] ], or where such limitation would be prohibited by mandatory provisions of law, the INSTITUTION’s total liability and indemnification obligation under this Agreement to the SPONSOR [and CRO jointly] under any and all circumstances for direct damages jointly shall under any and all circumstances not exceed (a) for damages covered under the civil liability insurance policy of the INSTITUTION in accordance with Article 7.6, the effective coverage under such insurance policy, and (b) for damages not covered under the civil liability insurance policy of the INSTITUTION (i) per occurrence an amount corresponding to the aggregated fees (excluding pass through costs) paid or/to be paid by the SPONSOR (and/or CRO) to the INSTITUTION for the Study under this Agreement; and (ii) in aggregate, an amount corresponding to [XX times] the aggregated fees paid/or to be paid by the SPONSOR (and/or CRO) to the INSTITUTION for the Study under this Agreement [or such other fixed amount as may be agreed upon by the Parties upon a case by case basis]. In any case abovementioned the INSTITUTION’s total liability and indemnification obligation under this Agreement to the SPONSOR [and CRO jointly] shall terminate upon the 10th (tenth) anniversary [or such other time as may be agreed upon by the Parties upon a case by case basis] of the end of the Study at the INSTITUTION in accordance with the Protocol. Notwithstanding anything to the contrary herein, [and except in case of gross negligence and/or wilful misconduct, [including breach of Sponsor Owned Inventions under Article 6.4.3, [...]], or where such limitation would be prohibited by mandatory provisions of law, in no event shall either Party be liable as between the Parties to the other for any indirect or consequential damages (including lost profits) to the extent not covered under the civil liability insurance policy arising out of the subject matter or performance obligations of this Agreement. The INSTITUTION declares that it has a mandatory civil Neither Requesting Agency nor any officer, employee, agent, or volunteer of Requesting Agency shall be responsible for any damage or liability insurance policy in accordance with Applicable Laws which notably covers the INSTITUTIONarising out of, its employees including the INVESTIGATOR and undertakes to maintain such insurance policy throughout the term of this Agreement and provides upon request of the SPONSOR any updated insurance certificate. The SPONSOR declares and warrants that it has a civil liability insurance policy which notably covers the SPONSOR and its employees and undertakes to maintain such insurance policy throughout the term of this Agreement and provides upon request of the INSTITUTION any updated insurance certificate. All Parties shall promptly inform each other of any claims pertaining to, or imminent claims relating to any acts or omissions on the conduct part of the Study. No admission or settlements in respect of the alleged liability of the other Party shall be made without the prior written approval of that Party (such consent not to be unreasonably withheld). For the avoidance of doubt, each Party shall be entitled to seek own counsel for any claims against itself Responding Agency or its employees. Notwithstanding the provisions set out in Article 7.4, nothing in this Article 7 shall operate so as to restrict or exclude the liability of any Party vis-à-vis the Study Participants in relation to their death or personal injury caused by the negligence of that Party or its agents or employees or to restrict or exclude any other liability of a Party which cannot be so restricted or excluded in law. INSPECTION AND AUDIT Upon request by any authorised officer or employee of any relevant regulatory agency, or other government authority, the INSTITUTION and the INVESTIGATOR are entitled and obliged to permit such officers or employees, at reasonable times, to have access to and inspect and verify any data records and reports in the INSTITUTION's and/or the INVESTIGATOR's possession, custody or control relating to the Study and shall submit such data records or reports to the said regulatory agency upon its request. In the case of a GCP inspection, the presence of a representative of SPONSOR is required unless otherwise stated by the SPONSOR. Unless prohibited by law or court order, the INSTITUTION and the INVESTIGATOR shall immediately inform the SPONSOR of any such inspection so as to allow the SPONSOR to be present to the inspection if he elects to be present, to allow the SPONSOR to prospectively review and comment on INSTITUTION’s responses, and send to the SPONSOR a copy of any such inspection report. The SPONSOR shall be entitled to audit or have audited (i) the INSTITUTION's fulfilment of its obligations hereunder (such as, but not limited to invoiced costs and expenses), and/or (ii) the performance of the Study by the INVESTIGATOR. The SPONSOR shall inform the INSTITUTION within a reasonable timeline compatible with the clinical activity of the INVESTIGATOR and INVESTIGATOR’s team. Upon request of SPONSOR, INSTITUTION and/or INVESTIGATOR shall provide to SPONSOR copies of all materials, reports, correspondence, statements, forms and records which INSTITUTION and/or INVESTIGATOR receives, obtains or generates pursuant to any inspection in connection with the Study, contractors under or in connection with any matter work, authority or jurisdiction delegated to and performed by Responding Agency or its contractors under this Agreement. It is also understood and agreed that, pursuant to Government Code section 895.4, Responding Agency shall fully indemnify, defend (with counsel approved by Requesting Agency) and hold Requesting Agency and its officers, employees, agents, and volunteers harmless from any liability imposed for injury (as defined by Government Code section 810.8) arising out of, pertaining to, or relating to any acts or omissions on the part of Responding Agency or its contractors under or in connection with any work, authority or jurisdiction delegated to and performed by Responding Agency or its contractors under this Agreement. Neither Responding Agency nor any officer, employee, agent or volunteer of Responding Agency shall be responsible for any damage or liability arising out of, pertaining to, or relating to any acts or omissions on the part of Requesting Agency or its contractors under or in connection with any work, authority or jurisdiction delegated to and performed by Requesting Agency or its contractors under this Agreement. It is also understood and agreed that, pursuant to Government Code section 895.4, Requesting Agency shall fully indemnify, defend (with counsel approved by Responding Agency) and hold Responding Agency and its officers, employees, agents, and volunteers harmless from any liability imposed for injury (as defined by Government Code section 810.8) arising out of, pertaining to, or relating to any acts or omissions on the part of Requesting Agency or its contractors under or in connection with any work, authority or jurisdiction delegated to and performed by Requesting Agency or its contractors under this Agreement. In the event Responding Agency and/or Requesting Agency is found to be comparatively at fault for any claim, action, loss or damage which results from their respective obligations under this Agreement, Responding Agency and/or Requesting Agency shall indemnify the other to the extent of its comparative fault. Requesting Agency and Responding Agency agree to waive all rights of subrogation against each other. Furthermore, if the Responding Agency or Requesting Agency attempts to seek recovery from the other for Workers’ Compensation benefits paid to an employee, the Responding Agency or Requesting Agency agree that may affect INSTITUTION’s OR INVESTIGATOR’s performance any alleged negligence of the Study, unless prohibited by law or court order and in line with INSTITUTION’s internal proceduresemployee shall not be construed against the employer of that employee.

Insurance and Indemnification. In accordance with Applicable Laws9.1 With respect to any design professional services provided by Consultant, the SPONSOR shall be liableConsultant agrees to indemnify, even without fault, for any damage incurred by a Study Participant or, in the case of death, his rightful claimants, that arises either in direct or indirect connection with the Study and shall provide compensation therefore. The SPONSOR shall enter into an insurance contract in accordance with Applicable Laws. Each Party, shall indemnify and hold harmless the otherCITY, its agents officers, and employees (collectively to the “Other Party’s Indemnitees”) fullest extent allowed by law from any and all duly evidenced liabilities, claims, actions, causes of action, damages, liabilities and losses, that arise out of, pertain to, or suits relate to the extent negligence, recklessness, or willful misconduct of the Consultant, except for any claims, actions, causes of action, losses, damages or liabilities proximately caused by its negligence or wrongful acts or omissions; or the negligence or wrongful acts or omissions of its agents or employees pertaining to the activities to be carried out pursuant to the obligations under this Agreement. Each Party shall promptly notify the other in writing of any such complaint, claim or injury relating to any loss subject to this indemnification. Neither Party shall indemnify and hold harmless the Other Party’s Indemnitees from liabilities arising out of negligence or wrongful acts or omissions of such Other Party’s Indemnitees. Without prejudice to SPONSOR’s no-fault liability towards Study Participants, the SPONSOR recognizes the need for the INVESTIGATOR to provide, at SPONSOR’s expense reasonable and necessary care for Study Participants involved in the Study with any adverse reaction in direct or indirect connection with the Study. In case of gross sole negligence or willful misconduct of CITY. CITY shall not be liable for acts of Consultant in performing services described herein. Notwithstanding anything in this paragraph to the INVESTIGATOR and/or INSTITUTIONcontrary, any defense costs charged to the design professional under this paragraph shall not exceed the design professional’s proportionate percentage of fault, except that in the event one or more defendants is unable to pay its share of defense costs due to bankruptcy or dissolution of the business, the SPONSOR may seek recourse against design professional shall meet and confer with the INVESTIGATOR and/or other parties regarding unpaid defense costs in good faith effort to agree on the INSTITUTIONallocation of those costs amongst the parties. Except in case of gross negligence or wilful misconductWith respect to all matters other than those covered by the foregoing paragraph, [including breach of Sponsor Owned Inventions under Article 6.4.3Consultant agrees to indemnify, […][…] ], or where such limitation would be prohibited by mandatory provisions of law, the INSTITUTION’s total liability and indemnification obligation under this Agreement defend (with counsel reasonably satisfactory to the SPONSOR [CITY) and CRO jointly] under hold harmless the CITY, its officers, officials, directors, agents representatives, volunteers, and employees to the fullest extent allowed by law from any and all circumstances claims, actions, causes of action, losses, damages, liabilities and costs of every nature, including but not limited to all claims, actions, causes of action, losses, damages, liabilities for direct damages jointly shall under any property damage, bodily injury, or death, and all circumstances costs of defending any claim, caused by or arising out of, or alleged to have been caused by or arise out of, in whole or in part, Consultant’s performance under this Agreement, except for any claims, actions, causes of action, losses, damages, costs or liabilities proximately caused by the sole negligence or willful misconduct of CITY. CITY shall not exceed (a) be liable for damages covered acts of Consultant in performing services described herein. In no event shall this section be construed to require indemnification by the Consultant to a greater extent than permitted under the civil liability insurance public policy of the INSTITUTION State of California; and in accordance with Article 7.6the event that this contract is subject to California Civil Code section 2782(b), the effective coverage under such insurance policyforegoing indemnity provisions shall not apply to any liability for the active negligence of the City. The defense and indemnity provisions obligations of this Agreement are undertaken in addition to, and (b) for damages shall not covered under the civil liability insurance policy of the INSTITUTION (i) per occurrence an amount corresponding to the aggregated fees (excluding pass through costs) paid or/to in any way be paid limited by the SPONSOR (and/or CRO) to the INSTITUTION for the Study under this Agreement; and (ii) insurance obligations contained in aggregate, an amount corresponding to [XX times] the aggregated fees paid/or to be paid by the SPONSOR (and/or CRO) to the INSTITUTION for the Study under this Agreement [or such other fixed amount as may be agreed upon by the Parties upon a case by case basis]. In any case abovementioned the INSTITUTION’s total liability and indemnification obligation under this Agreement to the SPONSOR [and CRO jointly] shall terminate upon the 10th (tenth) anniversary [or such other time as may be agreed upon by the Parties upon a case by case basis] of the end of the Study at the INSTITUTION in accordance with the Protocol. Notwithstanding anything to the contrary herein, [and except in case of gross negligence and/or wilful misconduct, [including breach of Sponsor Owned Inventions under Article 6.4.3, [...]], or where such limitation would be prohibited by mandatory provisions of law, in no event shall either Party be liable as between the Parties to the other for any indirect or consequential damages (including lost profits) to the extent not covered under the civil liability insurance policy arising out of the subject matter or performance of this Agreement. The INSTITUTION declares foregoing indemnity provisions are intended to fully allocate the parties’ risk of liability to third-parties; and there shall be no rights to indemnity or contribution, in law or equity or otherwise between the parties that it has a mandatory civil liability insurance policy are not set forth in accordance with Applicable Laws which notably covers this section. Consultant waives all rights to subrogation for any matters covered by the INSTITUTION, its employees including provisions of this section. Consultant’s responsibility for such defense and indemnity obligations as set forth in this section shall survive the INVESTIGATOR and undertakes to maintain such insurance policy throughout the term termination or completion of this Agreement and provides upon request for the full period of the SPONSOR any updated insurance certificate. The SPONSOR declares and warrants that it has a civil liability insurance policy which notably covers the SPONSOR and its employees and undertakes to maintain such insurance policy throughout the term of this Agreement and provides upon request of the INSTITUTION any updated insurance certificate. All Parties shall promptly inform each other of any claims or imminent claims relating to the conduct of the Study. No admission or settlements in respect of the alleged liability of the other Party shall be made without the prior written approval of that Party (such consent not to be unreasonably withheld). For the avoidance of doubt, each Party shall be entitled to seek own counsel for any claims against itself or its employees. Notwithstanding the provisions set out in Article 7.4, nothing in this Article 7 shall operate so as to restrict or exclude the liability of any Party vis-à-vis the Study Participants in relation to their death or personal injury caused time allowed by the negligence of that Party or its agents or employees or to restrict or exclude any other liability of a Party which cannot be so restricted or excluded in law. INSPECTION AND AUDIT Upon request by any authorised officer or employee of any relevant regulatory agency, or other government authority, the INSTITUTION and the INVESTIGATOR are entitled and obliged to permit such officers or employees, at reasonable times, to have access to and inspect and verify any data records and reports in the INSTITUTION's and/or the INVESTIGATOR's possession, custody or control relating to the Study and shall submit such data records or reports to the said regulatory agency upon its request. In the case of a GCP inspection, the presence of a representative of SPONSOR is required unless otherwise stated by the SPONSOR. Unless prohibited by law or court order, the INSTITUTION and the INVESTIGATOR shall immediately inform the SPONSOR of any such inspection so as to allow the SPONSOR to be present to the inspection if he elects to be present, to allow the SPONSOR to prospectively review and comment on INSTITUTION’s responses, and send to the SPONSOR a copy of any such inspection report. The SPONSOR shall be entitled to audit or have audited Consultant Services Agreement (i) the INSTITUTION's fulfilment of its obligations hereunder (such as, but not limited to invoiced costs and expensesRev. 1/23/18), and/or (ii) the performance of the Study by the INVESTIGATOR. The SPONSOR shall inform the INSTITUTION within a reasonable timeline compatible with the clinical activity of the INVESTIGATOR and INVESTIGATOR’s team. Upon request of SPONSOR, INSTITUTION and/or INVESTIGATOR shall provide to SPONSOR copies of all materials, reports, correspondence, statements, forms and records which INSTITUTION and/or INVESTIGATOR receives, obtains or generates pursuant to any inspection in connection with the Study, or in connection with any matter that may affect INSTITUTION’s OR INVESTIGATOR’s performance of the Study, unless prohibited by law or court order and in line with INSTITUTION’s internal procedures.

Insurance and Indemnification. In accordance with Applicable Lawsthe Belgian Law relating to experiments on the human person dated 07 May 2004, the SPONSOR shall be liableassume, even without fault, for the responsibility of any damage incurred by a Study Participant study patient or, in the case of death, his rightful claimants, claimants sustained that arises either in direct or indirect connection with the Study experiments and shall provide compensation therefore. The SPONSOR shall enter into an insurance contract in accordance with Applicable Lawsarticle 29 of the Belgian Law relating to experiments on the human person dated 07 May 2004. Each PartyThe INSTITUTION or INVESTIGATOR, respectively, shall indemnify indemnify, defend and hold harmless the otherSPONSOR, its agents and employees (collectively the “Other Party’s SPONSOR Indemnitees”) from any and all duly evidenced liabilities, claims, actions, or suits to the extent caused by its negligence or wrongful acts or omissions; or the resulting from negligence or wrongful acts or omissions of its the INSTITUTION or INVESTIGATOR, their respective agents or employees (collectively the “INSTITUTION or INVESTIGATOR Indemnitees”) pertaining to the activities to be carried out pursuant to the obligations under this Agreement. Each Party This indemnification obligation shall continue in effect after the date of expiration or earlier termination of this Agreement for a period of ten (10) years after which this obligation shall cease and expire. The SPONSOR shall promptly notify the other INSTITUTION or INVESTIGATOR in writing of any such complaint, claim or injury within thirty (30) days after a SPONSOR Xxxxxxxxxx’s receipt of notice of any complaint, claim or injury relating to any loss subject to this indemnification. Neither Party shall indemnify The INSTITUTION declares and hold harmless the Other Party’s Indemnitees from liabilities arising out of negligence or wrongful acts or omissions of such Other Party’s Indemnitees. Without prejudice to SPONSOR’s no-fault liability towards Study Participants, the SPONSOR recognizes the need for the INVESTIGATOR to provide, at SPONSOR’s expense reasonable and necessary care for Study Participants involved in the Study with any adverse reaction in direct or indirect connection with the Study. In case of gross negligence or willful misconduct of the INVESTIGATOR and/or INSTITUTION, the SPONSOR may seek recourse against the INVESTIGATOR and/or the INSTITUTION. Except in case of gross negligence or wilful misconduct, [including breach of Sponsor Owned Inventions under Article 6.4.3, […][…] ], or where such limitation would be prohibited by mandatory provisions of law, the INSTITUTION’s total liability and indemnification obligation under this Agreement to the SPONSOR [and CRO jointly] under any and all circumstances for direct damages jointly shall under any and all circumstances not exceed (a) for damages covered under the warrants that it has a civil liability insurance policy of the INSTITUTION in accordance with Article 7.6, the effective coverage under such insurance policy, and (b) for damages not covered under the civil liability insurance policy of the INSTITUTION (i) per occurrence an amount corresponding to the aggregated fees (excluding pass through costs) paid or/to be paid by the SPONSOR (and/or CRO) to the INSTITUTION for the Study under this Agreement; and (ii) in aggregate, an amount corresponding to [XX times] the aggregated fees paid/or to be paid by the SPONSOR (and/or CRO) to the INSTITUTION for the Study under this Agreement [or such other fixed amount as may be agreed upon by the Parties upon a case by case basis]. In any case abovementioned the INSTITUTION’s total liability and indemnification obligation under this Agreement to the SPONSOR [and CRO jointly] shall terminate upon the 10th (tenth) anniversary [or such other time as may be agreed upon by the Parties upon a case by case basis] of the end of the Study at the INSTITUTION in accordance with the Protocol. Notwithstanding anything to the contrary herein, [and except in case of gross negligence and/or wilful misconduct, [including breach of Sponsor Owned Inventions under Article 6.4.3, [...]], or where such limitation would be prohibited by mandatory provisions of law, in no event shall either Party be liable as between the Parties to the other for any indirect or consequential damages (including lost profits) to the extent not covered under the civil liability insurance policy arising out of the subject matter or performance of this Agreement. The INSTITUTION declares that it has a mandatory civil liability insurance policy in accordance with Applicable Laws which notably covers the INSTITUTION, its employees including the INVESTIGATOR and INSTITUTION’s employees and undertakes to maintain such insurance policy throughout the term of this Agreement and provides upon request of the SPONSOR any updated insurance certificate. The SPONSOR declares Neither the INSTITUTION nor INVESTIGATOR shall indemnify, defend and warrants that it has a civil liability insurance policy which notably covers hold harmless the SPONSOR and its employees and undertakes to maintain such insurance policy throughout the term Indemnitees from liabilities arising out of this Agreement and provides upon request negligence or wrongful acts or omissions of the SPONSOR Indemnitees. The INSTITUTION or INVESTIGATOR or their respective Indemnitees shall not make any updated insurance certificate. All Parties shall promptly inform each other of any claims or imminent claims statements relating to any claim or proceedings and shall fully rely on the conduct SPONSOR to handle the claim or proceedings. SPONSOR shall notify INSTITUTION and INVESTIGATOR of the Study. No admission progress and shall not make any statements nor settlements relating to any claim or settlements in respect of the alleged liability of the other Party shall be made proceeding that make a reference to INSTITUTION or INVESTIGATOR without the prior written approval of that Party (INSTITUTION or INVESTIGATOR, such consent approval not to be unreasonably withheld). For the avoidance of doubt, each Party shall be entitled to seek own counsel for any claims against itself or its employees. Notwithstanding the provisions set out in Article 7.4, nothing in this Article 7 shall operate so as to restrict or exclude the liability of any Party vis-à-vis the Study Participants in relation to their death or personal injury caused by the negligence of that Party or its agents or employees or to restrict or exclude any other liability of a Party which cannot be so restricted or excluded in law. INSPECTION AND AUDIT Upon request by any authorised officer or employee of any relevant regulatory agency, or other government authority, the INSTITUTION and the INVESTIGATOR are entitled and obliged to permit such officers or employees, at reasonable times, to have access to and inspect and verify any data records and reports in the INSTITUTION's and/or the INVESTIGATOR's possession, custody or control relating to the Study and shall submit such data records or reports to the said regulatory agency upon its request. In the case of a GCP inspection, the presence of a representative of SPONSOR is required unless otherwise stated by the SPONSOR. Unless prohibited by law or court order, the INSTITUTION and the INVESTIGATOR shall immediately inform the SPONSOR of any such inspection so as to allow the SPONSOR to be present to the inspection if he elects to be present, to allow the SPONSOR to prospectively review and comment on INSTITUTION’s responses, and send to the SPONSOR a copy of any such inspection report. The SPONSOR shall be entitled to audit or have audited (i) the INSTITUTION's fulfilment of its obligations hereunder (such as, but not limited to invoiced costs and expenses), and/or (ii) the performance of the Study by the INVESTIGATOR. The SPONSOR shall inform the INSTITUTION within a reasonable timeline compatible with the clinical activity of the INVESTIGATOR and INVESTIGATOR’s team. Upon request of SPONSOR, INSTITUTION and/or INVESTIGATOR shall provide to SPONSOR copies of all materials, reports, correspondence, statements, forms and records which INSTITUTION and/or INVESTIGATOR receives, obtains or generates pursuant to any inspection in connection with the Study, or in connection with any matter that may affect INSTITUTION’s OR INVESTIGATOR’s performance of the Study, unless prohibited by law or court order and in line with INSTITUTION’s internal procedures.

Insurance and Indemnification. In accordance The Participating Investigator(s)/ Institution has appropriate clinical trial insurance with Applicable Laws, the SPONSOR shall be liable, even without fault, for any damage incurred by coverage of damages or death as a Study Participant or, in the case of death, his rightful claimants, that arises either in direct or indirect connection with result of the Study study - of any, by Participating Investigator and shall provide compensation thereforeParticipating Institution, enrolled patient. The SPONSOR shall enter into an insurance contract in accordance with Applicable Laws. Each PartySPONSOR, including the research staff involved, shall indemnify not be liable and hold will be indemnified, defended, and held harmless by Participating Institution for injury to the other, its agents and employees (collectively subjects’ health which would also have occurred if the “Other Party’s Indemnitees”) from any and all duly evidenced liabilities, claims, actionssubject had not participated in the Study, or suits to for events resulting from diagnostic or therapeutic measures not required by the extent caused by its negligence or wrongful acts or omissions; or the negligence or wrongful acts or omissions Protocol because of its agents or employees pertaining to the activities to be carried out pursuant to the obligations under this Agreement. Each Party shall promptly notify the other in writing a lack of any such complaint, claim or injury relating to any loss subject to this indemnification. Neither Party shall indemnify and hold harmless the Other Party’s Indemnitees from liabilities arising out of negligence or wrongful acts or omissions of such Other Party’s Indemnitees. Without prejudice to SPONSOR’s no-fault liability towards Study Participants, the SPONSOR recognizes the need for the INVESTIGATOR to provide, at SPONSOR’s expense reasonable and necessary care for Study Participants involved in the Study with any adverse reaction in direct or indirect connection causal relation with the Study. In case of For events, claims, or proceedings, initiated by Study Subjects or any third party, arising from (I) a failure to comply with applicable laws, regulations or the Protocol, or (II) from gross negligence or willful misconduct or a willful, reckless, negligent, or wrongful act, or omission or professional malpractice of the INVESTIGATOR and/or INSTITUTIONParticipating Institution, the SPONSOR may seek recourse against the INVESTIGATOR and/or the INSTITUTION. Except in case of gross negligence Participating Investigator or wilful misconduct, [related clinical staff (including breach of Sponsor Owned Inventions under Article 6.4.3, […][…] ], or where such limitation would be prohibited by mandatory provisions of law, the INSTITUTIONfailure to obtain patient’s total liability and indemnification obligation under this Agreement to the SPONSOR [and CRO jointly] under any and all circumstances for direct damages jointly shall under any and all circumstances not exceed (a) for damages covered under the civil liability insurance policy of the INSTITUTION in accordance with Article 7.6, the effective coverage under such insurance policy, and (b) for damages not covered under the civil liability insurance policy of the INSTITUTION (i) per occurrence an amount corresponding to the aggregated fees (excluding pass through costs) paid or/to be paid by the SPONSOR (and/or CRO) to the INSTITUTION for the Study under this Agreement; and (ii) in aggregate, an amount corresponding to [XX times] the aggregated fees paid/or to be paid by the SPONSOR (and/or CRO) to the INSTITUTION for the Study under this Agreement [or such other fixed amount as may be agreed upon by the Parties upon a case by case basis]. In any case abovementioned the INSTITUTION’s total liability and indemnification obligation under this Agreement to the SPONSOR [and CRO jointly] shall terminate upon the 10th (tenth) anniversary [or such other time as may be agreed upon by the Parties upon a case by case basis] of the end of the Study at the INSTITUTION consent in accordance with the Protocolrules applicable thereto) the Sponsor, including the research staff involved in this Study, will be indemnified, defended and held harmless by Participating Institution. Notwithstanding anything The Participating Investigator warrants that a sufficient general and malpractice insurance program (on either an indemnity or self-insured basis) is in place to the contrary herein, [and except in case of gross negligence and/or wilful misconduct, [including breach of Sponsor Owned Inventions under Article 6.4.3, [...]]fully cover negligent or reckless acts, or where such limitation would be prohibited by mandatory provisions of law, omissions in no event shall either Party be liable as between the Parties to the other for any indirect or consequential damages (including lost profits) to the extent not covered under the civil liability insurance policy arising out of the subject matter or performance of this Agreementtheir duties, and shall be financially and legally responsible for all liabilities, costs, damages, expenses and attorney fees (collectively, "Liabilities") resulting from, or attributable to any and all such acts and omissions. The INSTITUTION declares that it has a mandatory civil liability Each Party will take out and maintain appropriate insurance policy in accordance with Applicable Laws which notably covers the INSTITUTION, its employees including the INVESTIGATOR and undertakes to maintain such insurance policy throughout the term of this Agreement and provides upon request of the SPONSOR any updated insurance certificate. The SPONSOR declares and warrants that it has a civil liability insurance policy which notably covers the SPONSOR and its employees and undertakes to maintain such insurance policy throughout the term of this Agreement and provides upon request of the INSTITUTION any updated insurance certificate. All Parties shall promptly inform each other of any claims or imminent claims relating to the conduct of the Study. No admission or settlements cover in respect of the alleged liability of the other its potential liability. Each Party shall be made without produce to the prior written approval other, on request, copies of insurance certificates or proof of dispensation for insurance, together with evidence that Party (such consent not the policies to be unreasonably withheld). For the avoidance of doubt, each Party shall be entitled to seek own counsel for any claims against itself or its employees. Notwithstanding the provisions set out which they refer remain in Article 7.4, nothing in this Article 7 shall operate so as to restrict or exclude the liability of any Party vis-à-vis the Study Participants in relation to their death or personal injury caused by the negligence of that Party or its agents or employees or to restrict or exclude any other liability of a Party which cannot be so restricted or excluded in law. INSPECTION AND AUDIT Upon request by any authorised officer or employee of any relevant regulatory agencyfull force and effect, or other government authority, evidence concerning the INSTITUTION and the INVESTIGATOR are entitled and obliged to permit such officers or employees, at reasonable times, to have access to and inspect and verify any data records and reports in the INSTITUTION's and/or the INVESTIGATOR's possession, custody or control relating to the Study and shall submit such data records or reports to the said regulatory agency upon its requestindemnity. In the case of a GCP inspection, the presence of a representative of SPONSOR is required unless otherwise stated by the SPONSOR. Unless prohibited by law or court order, the INSTITUTION and the INVESTIGATOR shall immediately inform the SPONSOR The terms of any such inspection so as to allow insurance or the SPONSOR to be present to the inspection if he elects to be present, to allow the SPONSOR to prospectively review and comment on INSTITUTION’s responses, and send to the SPONSOR amount of cover shall not relieve a copy Party of any such inspection report. The SPONSOR shall be entitled to audit or have audited (i) the INSTITUTION's fulfilment of its obligations hereunder (such as, but not limited to invoiced costs and expenses), and/or (ii) the performance of the Study by the INVESTIGATOR. The SPONSOR shall inform the INSTITUTION within a reasonable timeline compatible with the clinical activity of the INVESTIGATOR and INVESTIGATOR’s team. Upon request of SPONSOR, INSTITUTION and/or INVESTIGATOR shall provide to SPONSOR copies of all materials, reports, correspondence, statements, forms and records which INSTITUTION and/or INVESTIGATOR receives, obtains or generates pursuant to any inspection in connection with the Study, or in connection with any matter that may affect INSTITUTION’s OR INVESTIGATOR’s performance of the Study, unless prohibited by law or court order and in line with INSTITUTION’s internal proceduresliabilities under this Agreement.

Insurance and Indemnification. In accordance with Applicable Laws, the SPONSOR shall be liable, even without fault, for any damage incurred by a Study Participant or, in the case of death, his rightful claimants, that arises either in direct or indirect connection with the Study and shall provide compensation therefore. The SPONSOR shall enter into an insurance contract in accordance with Applicable Laws. Each Party, shall indemnify and hold harmless the other, its agents and employees (collectively the “Other Party’s Indemnitees”) from any and all duly evidenced liabilities, claims, actions, or suits Subject to the extent caused by its negligence or wrongful acts or omissions; or the negligence or wrongful acts or omissions of its agents or employees pertaining to the activities to be carried out pursuant to the obligations under this Agreement. Each Party minimum coverage requirements set forth below, PROVIDER shall promptly notify the other in writing of any such complaint, claim or injury relating to any loss subject to this indemnification. Neither Party shall indemnify procure and hold harmless the Other Party’s Indemnitees from liabilities arising out of negligence or wrongful acts or omissions of such Other Party’s Indemnitees. Without prejudice to SPONSOR’s no-fault liability towards Study Participants, the SPONSOR recognizes the need for the INVESTIGATOR to provide, maintain at SPONSOR’s expense reasonable and necessary care for Study Participants involved in the Study with any adverse reaction in direct or indirect connection with the Study. In case of gross negligence or willful misconduct of the INVESTIGATOR and/or INSTITUTION, the SPONSOR may seek recourse against the INVESTIGATOR and/or the INSTITUTION. Except in case of gross negligence or wilful misconduct, [including breach of Sponsor Owned Inventions under Article 6.4.3, […][…] ], or where such limitation would be prohibited by mandatory provisions of law, the INSTITUTION’s total liability and indemnification obligation under this Agreement to the SPONSOR [and CRO jointly] under any and all circumstances for direct damages jointly shall under any and all circumstances not exceed (a) for damages covered under the civil liability insurance policy of the INSTITUTION in accordance with Article 7.6, the effective coverage under such insurance policy, and (b) for damages not covered under the civil liability insurance policy of the INSTITUTION (i) per occurrence an amount corresponding to the aggregated fees (excluding pass through costs) paid or/to be paid by the SPONSOR (and/or CRO) to the INSTITUTION for the Study under this Agreement; and (ii) in aggregate, an amount corresponding to [XX times] the aggregated fees paid/or to be paid by the SPONSOR (and/or CRO) to the INSTITUTION for the Study under this Agreement [or such other fixed amount as may be agreed upon by the Parties upon a case by case basis]. In any case abovementioned the INSTITUTION’s total liability and indemnification obligation under this Agreement to the SPONSOR [and CRO jointly] shall terminate upon the 10th (tenth) anniversary [or such other time as may be agreed upon by the Parties upon a case by case basis] of the end of the Study at the INSTITUTION in accordance with the Protocol. Notwithstanding anything to the contrary herein, [and except in case of gross negligence and/or wilful misconduct, [including breach of Sponsor Owned Inventions under Article 6.4.3, [...]], or where such limitation would be prohibited by mandatory provisions of law, in no event shall either Party be liable as between the Parties to the other for any indirect or consequential damages (including lost profits) to the extent not covered under the civil liability insurance policy arising out of the subject matter or performance of this Agreement. The INSTITUTION declares that it has a mandatory civil liability insurance policy in accordance with Applicable Laws which notably covers the INSTITUTION, its employees including the INVESTIGATOR and undertakes to maintain such insurance policy times throughout the term of this Agreement such insurance as will fully protect PROVIDER from all acts, errors or omissions while providing the products and/or related services under this Agreement. PROVIDER shall submit to FACILITY prior to the effective date of this Agreement, a certificate of insurance issued by an insurer authorized to conduct insurance business in this state and provides upon request of the SPONSOR any updated insurance certificate. The SPONSOR declares and warrants reasonably acceptable to FACILITY, indicating that it PROVIDER has a civil complete liability insurance policy which notably covers coverage, including coverage for any acts of professional malpractice. Such insurance shall be in amounts reasonably satisfactory to FACILITY or in amounts required by the SPONSOR and its employees and undertakes to maintain such insurance policy throughout the term laws of this Agreement and provides upon request of the INSTITUTION any updated insurance certificate. All Parties state, whichever is greater, but shall promptly inform each other of any claims or imminent claims relating to the conduct of the Study. No admission or settlements in respect of the alleged liability of the other Party shall be made without the prior written approval of that Party (such consent not to be unreasonably withheld). For the avoidance of doubt, each Party shall be entitled to seek own counsel for any claims against itself or its employees. Notwithstanding the provisions set out in Article 7.4, nothing in this Article 7 shall operate so as to restrict or exclude the liability of any Party vis-à-vis the Study Participants in relation to their death or personal injury caused by the negligence of that Party or its agents or employees or to restrict or exclude any other liability of a Party which cannot be so restricted less than $1,000,000 per injury or excluded incident to persons and $3,000,000 aggregate per year and $100,000 each occurrence property damage coverage. Coverage in lawamounts less than stated must be approved in writing in advance by FACILITY's Corporate Risk Management Department. INSPECTION AND AUDIT Upon request by any authorised officer or employee Said certificate shall provide that the insurer will not cancel said policy of any relevant regulatory agencyinsurance without giving FACILITY thirty (30) days advance written notice. Further, or other government authority, the INSTITUTION and the INVESTIGATOR are entitled and obliged to permit such officers or employees, at reasonable times, to have access to and inspect and verify any data records and reports in the INSTITUTION's and/or the INVESTIGATOR's possession, custody or control relating to the Study and shall submit such data records or reports to the said regulatory agency upon its request. In the case of a GCP inspection, the presence of a representative of SPONSOR is required unless otherwise stated by the SPONSOR. Unless prohibited by law or court order, the INSTITUTION and the INVESTIGATOR shall immediately inform the SPONSOR of any such inspection so as to allow the SPONSOR to be present to the inspection if he elects to be present, to allow the SPONSOR to prospectively review and comment on INSTITUTION’s responses, and send to the SPONSOR a copy of any such inspection report. The SPONSOR shall be entitled to audit or have audited (i) the INSTITUTION's fulfilment of its obligations hereunder (such as, but not limited to invoiced costs and expenses), and/or (ii) the performance of the Study by the INVESTIGATOR. The SPONSOR shall inform the INSTITUTION within a reasonable timeline compatible with the clinical activity of the INVESTIGATOR and INVESTIGATOR’s team. Upon request of SPONSOR, INSTITUTION and/or INVESTIGATOR PROVIDER shall provide to SPONSOR copies of all materials, reports, correspondence, statements, forms and records which INSTITUTION and/or INVESTIGATOR receives, obtains FACILITY thirty (30) days advance written notice (or generates pursuant as soon as practicable) as to any inspection in connection material restriction, limitation, modification or revision to the coverage contemplated herein. PROVIDER shall save, indemnify and hold FACILITY harmless of and from any and all liability, loss, costs and expenses incurred directly or indirectly from any acts, errors or omissions by PROVIDER, its agents, employees, invitees from any cause arising from or relating to PROVIDER'S performance under this Agreement. Within the limits of its applicable insurance coverage and to the extent not otherwise inconsistent with the Studystate law, FACILITY shall save, indemnify and hold PROVIDER harmless of and from any and all liability, loss, costs and expenses incurred directly or in connection with indirectly by FACILITY, its agents, employees or invitees from any matter that may affect INSTITUTION’s OR INVESTIGATOR’s cause arising from or relating to FACILITY's performance of the Study, unless prohibited by law or court order and in line with INSTITUTION’s internal proceduresunder this Agreement.

Insurance and Indemnification. In accordance with Applicable LawsLandlord shall hold Tenant harmless from and defend and indemnify Tenant against any and all claims or liabilities for any injury or damage to any person or property whatsoever occurring in, on or about the SPONSOR Building or the Land (excluding the Premises) when such injury or damage shall be liablecaused in part or in whole by the act, even without faultneglect, for fault of or omission of any damage incurred duty with respect to the same by a Study Participant or, in the case of death, his rightful claimants, that arises either in direct or indirect connection with the Study and shall provide compensation therefore. The SPONSOR shall enter into an insurance contract in accordance with Applicable Laws. Each Party, shall indemnify and hold harmless the otherLandlord, its agents agents, servants, employees or invitees. Landlord further agrees to indemnify, defend and employees (collectively the “Other Party’s Indemnitees”) save harmless Tenant against and from any and all duly evidenced liabilities, claims, actionsclaims in any manner relating to any work or thing whatsoever done by Landlord in or about, or suits to any transaction of Landlord concerning, the extent caused by its negligence or wrongful acts or omissions; Land or the negligence Building (excluding the Premises) and will further indemnify, defend and save Tenant harmless against and from any and all claims arising from any breach or wrongful acts default on the part of Landlord in the performance of any covenant or omissions agreement on the part of its agents or employees pertaining to the activities Landlord to be carried out performed pursuant to the obligations under terms of this AgreementLease (including, but not limited to, Landlord’s agreement herein to pay brokerage commissions or fees) or arising from any act or negligence of Landlord or any of its agents, contractors, servants, employees and licensees. Each Party shall promptly notify the other in writing The provisions of any such complaint, claim or injury relating this Lease with respect to any loss subject to this indemnification. Neither Party shall indemnify and hold harmless the Other Party’s Indemnitees from liabilities arising out of negligence claims or wrongful acts or omissions of such Other Party’s Indemnitees. Without prejudice to SPONSOR’s no-fault liability towards Study Participants, the SPONSOR recognizes the need for the INVESTIGATOR to provide, at SPONSOR’s expense reasonable and necessary care for Study Participants involved in the Study with any adverse reaction in direct or indirect connection with the Study. In case of gross negligence or willful misconduct of the INVESTIGATOR and/or INSTITUTION, the SPONSOR may seek recourse against the INVESTIGATOR and/or the INSTITUTION. Except in case of gross negligence or wilful misconduct, [including breach of Sponsor Owned Inventions under Article 6.4.3, […][…] ], or where such limitation would be prohibited by mandatory provisions of law, the INSTITUTION’s total liability and indemnification obligation under this Agreement occurring prior to the SPONSOR [and CRO jointly] under any and all circumstances for direct damages jointly shall under any and all circumstances not exceed (a) for damages covered under the civil liability insurance policy of the INSTITUTION in accordance with Article 7.6, the effective coverage under such insurance policy, and (b) for damages not covered under the civil liability insurance policy of the INSTITUTION (i) per occurrence an amount corresponding to the aggregated fees (excluding pass through costs) paid or/to be paid by the SPONSOR (and/or CRO) to the INSTITUTION for the Study under this Agreement; and (ii) in aggregate, an amount corresponding to [XX times] the aggregated fees paid/termination or to be paid by the SPONSOR (and/or CRO) to the INSTITUTION for the Study under this Agreement [or such other fixed amount as may be agreed upon by the Parties upon a case by case basis]. In any case abovementioned the INSTITUTION’s total liability and indemnification obligation under this Agreement to the SPONSOR [and CRO jointly] shall terminate upon the 10th (tenth) anniversary [or such other time as may be agreed upon by the Parties upon a case by case basis] of the end of the Study at the INSTITUTION in accordance with the Protocol. Notwithstanding anything to the contrary herein, [and except in case of gross negligence and/or wilful misconduct, [including breach of Sponsor Owned Inventions under Article 6.4.3, [...]], or where such limitation would be prohibited by mandatory provisions of law, in no event shall either Party be liable as between the Parties to the other for any indirect or consequential damages (including lost profits) to the extent not covered under the civil liability insurance policy arising out of the subject matter or performance expiration of this AgreementLease shall expressly survive such termination or expiration of this Lease. The INSTITUTION declares that it has a mandatory civil liability insurance policy in accordance with Applicable Laws which notably covers the INSTITUTION, Landlord shall procure at its employees including the INVESTIGATOR expense and undertakes to maintain such insurance policy throughout the term of this Agreement and provides upon request Lease a policy or policies of commercial property insurance, issued on an “all risk” basis, insuring the full replacement cost of the SPONSOR any updated Building and improvements to the Building (other than tenant improvements), together with the furniture, equipment, supplies and other property owned, leased, held or used by Landlord in connection with the operation and maintenance of the Building (with a replacement cost endorsement sufficient to prevent Landlord from becoming a co-insurer), and workmen’s compensation insurance certificateas required by applicable law. The SPONSOR declares Landlord shall also procure at its expense and warrants that it has a civil liability insurance policy which notably covers the SPONSOR and its employees and undertakes to maintain such insurance policy throughout the term of this Agreement Lease a policy or policies of commercial general liability insurance, written on an occurrence basis, and provides upon request insuring Landlord against any and all liability for injury to or death of person or persons and for damage to property occasioned by or arising out of the INSTITUTION any updated insurance certificate. All Parties shall promptly inform each other of any claims condition, use or imminent claims relating to the conduct occupancy of the Study. No admission or settlements in respect of the alleged liability of the other Party shall be made without the prior written approval of that Party (such consent not to be unreasonably withheld). For the avoidance of doubt, each Party shall be entitled to seek own counsel for any claims against itself or its employees. Notwithstanding the provisions set out in Article 7.4, nothing in this Article 7 shall operate so as to restrict or exclude the liability of any Party vis-à-vis the Study Participants in relation to their death or personal injury caused by the negligence of that Party or its agents or employees or to restrict or exclude any other liability of a Party which cannot be so restricted or excluded in law. INSPECTION AND AUDIT Upon request by any authorised officer or employee of any relevant regulatory agency, or other government authority, the INSTITUTION and the INVESTIGATOR are entitled and obliged to permit such officers or employees, at reasonable times, to have access to and inspect and verify any data records and reports in the INSTITUTION's and/or the INVESTIGATOR's possession, custody or control relating to the Study and shall submit such data records or reports to the said regulatory agency upon its request. In the case of a GCP inspection, the presence of a representative of SPONSOR is required unless otherwise stated by the SPONSOR. Unless prohibited by law or court order, the INSTITUTION and the INVESTIGATOR shall immediately inform the SPONSOR of any such inspection so as to allow the SPONSOR to be present to the inspection if he elects to be present, to allow the SPONSOR to prospectively review and comment on INSTITUTION’s responses, and send to the SPONSOR a copy of any such inspection report. The SPONSOR shall be entitled to audit or have audited (i) the INSTITUTION's fulfilment of its obligations hereunder (such as, but not limited to invoiced costs and expenses), and/or (ii) the performance of the Study by the INVESTIGATOR. The SPONSOR shall inform the INSTITUTION within a reasonable timeline compatible with the clinical activity of the INVESTIGATOR and INVESTIGATOR’s team. Upon request of SPONSOR, INSTITUTION and/or INVESTIGATOR shall provide to SPONSOR copies of all materials, reports, correspondence, statements, forms and records which INSTITUTION and/or INVESTIGATOR receives, obtains or generates pursuant to any inspection in connection with the StudyBuilding, or in connection with any matter that may affect INSTITUTION’s OR INVESTIGATOR’s performance way occasioned by or arising out of the Studyactivities of Landlord, unless prohibited by law its agents, contractors, employees, guests, or court order licensees in the Building, the limit of such policy or policies to be in combined single limits for both damaged property and personal liability in line amounts of not less than Five Million Dollars ($5,000,000.00) for each occurrence. Tenant shall be identified as an additional insured with INSTITUTIONrespect to the Building under Landlord’s internal procedures.commercial general liability

Insurance and Indemnification. In accordance Borrower shall provide, maintain and keep in force at all times insurance on or with Applicable Lawsrespect to the Mortgaged Property in amounts and with coverages satisfactory to the Agent. If the Agent is made a party defendant to any litigation concerning the Loan Documents or the Mortgaged Property or any part thereof or interest therein, or the SPONSOR occupancy thereof by Borrower, then Borrower shall be liableindemnify, even without faultdefend and hold the Agent harmless from all liability by reason of said litigation, for any damage including reasonable attorneys' fees and expenses incurred by a Study Participant orthe Agent in any such litigation, in the case of death, his rightful claimants, that arises either in direct whether or indirect connection with the Study and shall provide compensation thereforenot any such litigation is prosecuted to judgment. The SPONSOR shall enter into an insurance contract in accordance with Applicable Laws. Each Party, shall indemnify and hold harmless the other, its agents and employees (collectively the “Other Party’s Indemnitees”) from Borrower waives any and all duly evidenced liabilitiesright to claim or recover against the Agent, claimsits officers, actionsemployees, agents and representatives, for loss of or suits damage to Borrower, the extent caused by its negligence or wrongful acts or omissions; Mortgaged Property, other property of Borrower or the negligence property of others under control of Borrower from any cause insured against or wrongful acts or omissions of its agents or employees pertaining to the activities required to be carried out pursuant to insured against by the obligations under this Agreement. Each Party shall promptly notify the other in writing of any such complaint, claim or injury relating to any loss subject to this indemnification. Neither Party shall indemnify and hold harmless the Other Party’s Indemnitees from liabilities arising out of negligence or wrongful acts or omissions of such Other Party’s Indemnitees. Without prejudice to SPONSOR’s no-fault liability towards Study Participants, the SPONSOR recognizes the need for the INVESTIGATOR to provide, at SPONSOR’s expense reasonable and necessary care for Study Participants involved in the Study with any adverse reaction in direct or indirect connection with the Study. In case of gross negligence or willful misconduct of the INVESTIGATOR and/or INSTITUTION, the SPONSOR may seek recourse against the INVESTIGATOR and/or the INSTITUTION. Except in case of gross negligence or wilful misconduct, [including breach of Sponsor Owned Inventions under Article 6.4.3, […][…] ], or where such limitation would be prohibited by mandatory provisions of law, the INSTITUTION’s total liability and indemnification obligation under this Agreement to the SPONSOR [and CRO jointly] under any and all circumstances for direct damages jointly shall under any and all circumstances not exceed (a) for damages covered under the civil liability insurance policy of the INSTITUTION in accordance with Article 7.6, the effective coverage under such insurance policy, and (b) for damages not covered under the civil liability insurance policy of the INSTITUTION (i) per occurrence an amount corresponding to the aggregated fees (excluding pass through costs) paid or/to be paid by the SPONSOR (and/or CRO) to the INSTITUTION for the Study under this Agreement; and (ii) in aggregate, an amount corresponding to [XX times] the aggregated fees paid/or to be paid by the SPONSOR (and/or CRO) to the INSTITUTION for the Study under this Agreement [or such other fixed amount as may be agreed upon by the Parties upon a case by case basis]. In any case abovementioned the INSTITUTION’s total liability and indemnification obligation under this Agreement to the SPONSOR [and CRO jointly] shall terminate upon the 10th (tenth) anniversary [or such other time as may be agreed upon by the Parties upon a case by case basis] of the end of the Study at the INSTITUTION in accordance with the Protocol. Notwithstanding anything to the contrary herein, [and except in case of gross negligence and/or wilful misconduct, [including breach of Sponsor Owned Inventions under Article 6.4.3, [...]], or where such limitation would be prohibited by mandatory provisions of law, in no event shall either Party be liable as between the Parties to the other for any indirect or consequential damages (including lost profits) to the extent not covered under the civil liability insurance policy arising out of the subject matter or performance of this AgreementMortgage. The INSTITUTION declares that it has a mandatory civil liability insurance policy in accordance with Applicable Laws which notably covers the INSTITUTION, its employees including the INVESTIGATOR and undertakes to maintain such insurance policy throughout the term of this Agreement and provides upon request of the SPONSOR any updated insurance certificate. The SPONSOR declares and warrants that it has a civil liability insurance policy which notably covers the SPONSOR and its employees and undertakes to maintain such insurance policy throughout the term of this Agreement and provides upon request of the INSTITUTION any updated insurance certificate. All Parties shall promptly inform each other of any claims or imminent claims relating to the conduct of the Study. No admission or settlements in respect of the alleged liability of the other Party shall be made without the prior written approval of that Party (such consent not to be unreasonably withheld). For the avoidance of doubt, each Party Agent shall be entitled to seek own counsel receive all of the proceeds of such insurance, and if (x) no Default (as hereinafter defined) shall then have occurred and be continuing, Borrower shall be have the right to use such proceeds toward the repair or replacement of the damaged or destroyed portion of the Improvements and Personal Property, or (y) a Default shall then have occurred and be continuing, the Agent may elect either to apply such proceeds, in whole or in part, toward payment of the Loans, the unpaid portion of the debt to remain in force, or to hold and apply such proceeds, without payment or allowance of interest thereon, toward the repair or replacement of the damaged or destroyed portion of the Improvements and Personal Property. Borrower hereby authorizes and empowers the Agent, on behalf of the Lenders, to settle or compromise claims under all such policies provided that same shall be reasonable under the circumstances then existing and to demand, receive and receipt for any claims against itself all monies becoming payable thereunder, whether or its employeesnot the policies are held by Borrower and whether or not they are made payable to the Agent, and the companies issuing such insurance policies are hereby notified, instructed, empowered and authorized to make loss drafts payable to the Agent, for the benefit of the Lenders. Notwithstanding If the provisions set out in Article 7.4, nothing in this Article 7 shall operate so as to restrict or exclude the liability of any Party vis-à-vis the Study Participants in relation to their death or personal injury caused insurance proceeds are held by the negligence Agent to reimburse Borrower for the cost of that Party or its agents or employees or to restrict or exclude any other liability restoration and repair of a Party which cannot be so restricted or excluded in law. INSPECTION AND AUDIT Upon request by any authorised officer or employee of any relevant regulatory agency, or other government authoritythe Improvements and the Personal Property, the INSTITUTION Improvements and Personal Property shall be restored as nearly as practicable to the INVESTIGATOR are entitled value, condition and obliged character thereof existing immediately prior to permit such officers damage or employeesdestruction or such other value, condition or character as the Agent may approve in writing. The Agent may, at reasonable timesthe Agent's option, condition disbursement of said proceeds on the Agent's approval of such plans and specifications of an architect satisfactory to have access the Agent, cost estimates of contractors satisfactory to the Agent, architect's certificates, waivers of liens, sworn statements of mechanics and inspect materialmen and verify such other evidence of costs, percentage completion of construction, application of payments, and satisfaction of liens as the Agent may reasonably require. If the insurance proceeds are applied to the payment of the sums secured by this Mortgage, any data records and reports such application of proceeds shall not extend or postpone the due dates of the monthly installments referred to in the INSTITUTION's and/or Agreement or change the INVESTIGATOR's possession, custody amounts of such installments. If the Mortgaged Property is sold pursuant to Section 19 hereof or control relating if the Agent acquires title to the Study Mortgaged Property, the Agent shall have all of the right, title and shall submit such data records or reports interest of Borrower in and to any insurance policies and unearned premiums thereon and in and to the said regulatory agency upon its request. In the case of a GCP inspection, the presence of a representative of SPONSOR is required unless otherwise stated by the SPONSOR. Unless prohibited by law or court order, the INSTITUTION and the INVESTIGATOR shall immediately inform the SPONSOR of proceeds resulting from any such inspection so as to allow the SPONSOR to be present damage to the inspection if he elects Mortgaged Property prior to be present, to allow the SPONSOR to prospectively review and comment on INSTITUTION’s responses, and send to the SPONSOR a copy of any such inspection report. The SPONSOR shall be entitled to audit sale or have audited (i) the INSTITUTION's fulfilment of its obligations hereunder (such as, but not limited to invoiced costs and expenses), and/or (ii) the performance of the Study by the INVESTIGATOR. The SPONSOR shall inform the INSTITUTION within a reasonable timeline compatible with the clinical activity of the INVESTIGATOR and INVESTIGATOR’s team. Upon request of SPONSOR, INSTITUTION and/or INVESTIGATOR shall provide to SPONSOR copies of all materials, reports, correspondence, statements, forms and records which INSTITUTION and/or INVESTIGATOR receives, obtains or generates pursuant to any inspection in connection with the Study, or in connection with any matter that may affect INSTITUTION’s OR INVESTIGATOR’s performance of the Study, unless prohibited by law or court order and in line with INSTITUTION’s internal proceduresacquisition.

Insurance and Indemnification. In accordance with Applicable Laws, the SPONSOR shall be liableassume, even without fault, for the responsibility of any damage incurred by a Study Participant or, in the case of death, his rightful claimants, that arises either in direct or indirect connection with the Study experiments and shall provide compensation therefore. The SPONSOR shall enter into an insurance contract in accordance with Applicable Laws. Each Party, shall indemnify and hold harmless the other, its agents and employees (collectively the “Other Party’s Indemnitees”) from any and all duly evidenced liabilities, claims, actions, or suits to the extent caused by its negligence or wrongful acts or omissions; or the negligence or wrongful acts or omissions of its agents or employees pertaining to the activities to be carried out pursuant to the obligations under this Agreement. Each Party shall promptly notify the other in writing of any such complaint, claim or injury relating to any loss subject to this indemnification. Neither Party shall indemnify and hold harmless the Other Party’s Indemnitees from liabilities arising out of negligence or wrongful acts or omissions of such Other Party’s Indemnitees. Without prejudice to SPONSOR’s no-fault liability towards Study ParticipantsParticipant, the SPONSOR recognizes the need for the INVESTIGATOR to provide, at SPONSOR’s expense reasonable and necessary care for Study Participants involved in the Study with any adverse reaction in direct or indirect connection with the Study. In case of gross negligence or willful misconduct of the INVESTIGATOR and/or INSTITUTION, the SPONSOR may seek recourse against the INVESTIGATOR and/or the INSTITUTION. Except in case of gross negligence or wilful misconduct, [including breach of Sponsor Owned Inventions SPONSOR IP under Article 6.4.3., […][…] ], or where such limitation would be prohibited by mandatory provisions of law, the INSTITUTION’s total liability and indemnification obligation under this Agreement to the SPONSOR [and CRO jointly] under any and all circumstances for direct damages jointly shall under any and all circumstances not exceed (a) for damages covered under the civil liability insurance policy of the INSTITUTION in accordance with Article article 7.6, the effective coverage under such insurance policy, and (b) for damages not covered under the civil liability insurance policy of the INSTITUTION (i) per occurrence an amount corresponding to the aggregated fees (excluding pass through costs) paid or/to be paid by the SPONSOR (and/or CRO) to the INSTITUTION for the Study under this Agreement; and and/or (ii) in aggregate, an amount corresponding to [XX times] the aggregated fees paid/or to be paid by the SPONSOR (and/or CRO) to the INSTITUTION for the Study under this Agreement [or such other fixed amount as may be agreed upon by the Parties upon a case by case basis]. In any case abovementioned the INSTITUTION’s total liability and indemnification obligation under this Agreement to the SPONSOR [and CRO jointly] shall terminate upon the 10th (tenth) anniversary [or such other time as may be agreed upon by the Parties upon a case by case basis] of the end date of the Study at the INSTITUTION in accordance with the Protocol. Notwithstanding anything to the contrary herein, [and except in case of gross negligence and/or wilful misconduct, [including breach of Sponsor Owned Inventions SPONSOR IP under Article 6.4.3., [...]], or where such limitation would be prohibited by mandatory provisions of law, in no event shall either Party be liable as between the Parties to the other for any indirect or consequential damages (including lost profits) to the extent not covered under the civil liability insurance policy arising out of the subject matter or performance of this Agreement. The INSTITUTION declares that it has a mandatory civil liability insurance policy in accordance with Applicable Laws which notably covers the INSTITUTION, its employees including and the INVESTIGATOR (if not an employee) and undertakes to maintain such insurance policy throughout the term of this Agreement and provides upon request of the SPONSOR any updated insurance certificate. The SPONSOR declares and warrants that it has a civil liability insurance policy which notably covers the SPONSOR and its employees and undertakes to maintain such insurance policy throughout the term of this Agreement and provides upon request of the INSTITUTION any updated insurance certificate. Neither Party shall indemnify and hold harmless the Other Party’s Indemnitees from liabilities arising out of gross negligence or wrongful acts or omissions of such Other Party’s Indemnitees. All Parties shall promptly inform each other of any claims or imminent claims relating to the conduct of the Study. No admission or settlements in respect of the alleged liability of the other Party shall be made without the prior written approval of that Party (such consent not to the other Party. If one of the Parties admits liability, it shall be unreasonably withheld)given full conduct and control of any defense proceedings and negotiations concerning claims against the liable party. For the avoidance of doubt, each Party shall be entitled to seek own counsel for any claims against itself or its employees. Notwithstanding the provisions set out in Article 7.4., nothing in this Article 7 shall operate so as to restrict or exclude the liability of any Party vis-à-vis the Study Participants in relation to their death or personal injury caused by the negligence of that Party or its agents or employees or to restrict or exclude any other liability of a Party which cannot be so restricted or excluded in law. INSPECTION AND AUDIT Upon request by any authorised officer or employee of any relevant regulatory agency, or other government authority, the INSTITUTION and the INVESTIGATOR are entitled and obliged to permit such officers or employees, at reasonable times, to have access to and inspect and verify any data records and reports in the INSTITUTION's and/or the INVESTIGATOR's possession, custody or control relating to the Study and shall submit such data records or reports to the said regulatory agency upon its request. In the case of a GCP inspection, the presence of a representative of the SPONSOR is required unless otherwise stated by the SPONSOR. Unless prohibited by law or court order, the INSTITUTION and the INVESTIGATOR shall immediately inform the SPONSOR of any such inspection so as to allow the SPONSOR to be present to the inspection if he elects to be present, to allow the SPONSOR to prospectively review and comment on INSTITUTION’s responses, and send to the SPONSOR a copy of any such inspection reportreport . The SPONSOR shall be entitled at any time to audit or have audited (i) the INSTITUTION's fulfilment of its obligations hereunder (such as, but not limited to invoiced costs and expenses), and/or (ii) the performance of the Study by the INVESTIGATOR. The SPONSOR shall inform the INSTITUTION within a reasonable timeline compatible with the clinical activity of the INVESTIGATOR and INVESTIGATOR’s team. Upon request of SPONSOR, INSTITUTION and/or INVESTIGATOR shall provide to SPONSOR copies of all materials, reports, correspondence, statements, forms and records which INSTITUTION and/or INVESTIGATOR receives, obtains or generates pursuant to any inspection in connection with the Study, or in connection with any matter that may affect INSTITUTION’s OR INVESTIGATOR’s performance of the Study, unless prohibited by law or court order and in line with INSTITUTION’s internal procedures.

Insurance and Indemnification. In accordance with Applicable Laws, the SPONSOR shall be liable, even without fault, for any damage incurred by a Study Participant or, in the case of death, his rightful claimants, that arises either in direct or indirect connection with the Study and shall provide compensation therefore. The SPONSOR shall enter into an insurance contract in accordance with Applicable Laws. Each Party, shall indemnify and hold harmless the other, its agents and employees (collectively the “Other Party’s Indemnitees”) from any and all duly evidenced liabilities, claims, actions, or suits to the extent caused by its negligence or wrongful acts or omissions; or the negligence or wrongful acts or omissions of its agents or employees pertaining to the activities to be carried out pursuant to the obligations under this Agreement. Each Party shall promptly notify the other in writing of any such complaint, claim or injury relating to any loss subject to this indemnification. Neither Party shall indemnify and hold harmless the Other Party’s Indemnitees from liabilities arising out of negligence or wrongful acts or omissions of such Other Party’s Indemnitees. Without prejudice to SPONSOR’s no-fault liability towards Study Participants, the SPONSOR recognizes the need for the INVESTIGATOR to provide, at SPONSOR’s expense reasonable and necessary care for Study Participants involved in the Study with any adverse reaction in direct or indirect connection with the Study. In case of gross negligence or willful misconduct of the INVESTIGATOR and/or INSTITUTION, the SPONSOR may seek recourse against the INVESTIGATOR and/or the INSTITUTION. Except in case of gross negligence or wilful misconduct, [including breach of Sponsor Owned Inventions under Article 6.4.3., […][…] ], or where such limitation would be prohibited by mandatory provisions of law, the INSTITUTION’s total liability and indemnification obligation under this Agreement to the SPONSOR [and CRO jointly] under any and all circumstances for direct damages jointly shall under any and all circumstances not exceed (a) for damages covered under the civil liability insurance policy of the INSTITUTION in accordance with Article 7.6., the effective coverage under such insurance policy, and (b) for damages not covered under the civil liability insurance policy of the INSTITUTION (i) per occurrence an amount corresponding to the aggregated fees (excluding pass through costs) paid or/to be paid by the SPONSOR (and/or CRO) to the INSTITUTION for the Study under this Agreement; and (ii) in aggregate, an amount corresponding to [XX times] the aggregated fees paid/or to be paid by the SPONSOR (and/or CRO) to the INSTITUTION for the Study under this Agreement [or such other fixed amount as may be agreed upon by the Parties upon a case by case basis]. In any case abovementioned the INSTITUTION’s total liability and indemnification obligation under this Agreement to the SPONSOR [and CRO jointly] shall terminate upon the 10th (tenth) anniversary [or such other time as may be agreed upon by the Parties upon a case by case basis] of the end of the Study at the INSTITUTION in accordance with the Protocol. Notwithstanding anything to the contrary herein, [and except in case of gross negligence and/or wilful misconduct, [including breach of Sponsor Owned Inventions under Article 6.4.3., [...]], or where such limitation would be prohibited by mandatory provisions of law, in no event shall either Party be liable as between the Parties to the other for any indirect or consequential damages (including lost profits) to the extent not covered under the civil liability insurance policy arising out of the subject matter or performance of this Agreement. The INSTITUTION declares that it has a mandatory civil liability insurance policy in accordance with Applicable Laws which notably covers the INSTITUTION, its employees including the INVESTIGATOR and undertakes to maintain such insurance policy throughout the term of this Agreement and provides upon request of the SPONSOR any updated insurance certificate. The SPONSOR declares and warrants that it has a civil liability insurance policy which notably covers the SPONSOR and its employees and undertakes to maintain such insurance policy throughout the term of this Agreement and provides upon request of the INSTITUTION any updated insurance certificate. All Parties shall promptly inform each other of any claims or imminent claims relating to the conduct of the Study. No admission or settlements in respect of the alleged liability of the other Party shall be made without the prior written approval of that Party (such consent not to be unreasonably withheld). For the avoidance of doubt, each Party shall be entitled to seek own counsel for any claims against itself or its employees. Notwithstanding the provisions set out in Article 7.4., nothing in this Article 7 7. shall operate so as to restrict or exclude the liability of any Party vis-à-vis the Study Participants in relation to their death or personal injury caused by the negligence of that Party or its agents or employees or to restrict or exclude any other liability of a Party which cannot be so restricted or excluded in law. INSPECTION AND AUDIT Upon request by any authorised officer or employee of any relevant regulatory agency, or other government authority, the INSTITUTION and the INVESTIGATOR are entitled and obliged to permit such officers or employees, at reasonable times, to have access to and inspect and verify any data records and reports in the INSTITUTION's and/or the INVESTIGATOR's possession, custody or control relating to the Study and shall submit such data records or reports to the said regulatory agency upon its request. In the case of a GCP inspection, the presence of a representative of SPONSOR is required unless otherwise stated by the SPONSOR. Unless prohibited by law or court order, the INSTITUTION and the INVESTIGATOR shall immediately inform the SPONSOR of any such inspection so as to allow the SPONSOR to be present to the inspection if he elects to be present, to allow the SPONSOR to prospectively review and comment on INSTITUTION’s responses, and send to the SPONSOR a copy of any such inspection report. The SPONSOR shall be entitled to audit or have audited (i) the INSTITUTION's fulfilment of its obligations hereunder (such as, but not limited to invoiced costs and expenses), and/or (ii) the performance of the Study by the INVESTIGATOR. The SPONSOR shall inform the INSTITUTION within a reasonable timeline compatible with the clinical activity of the INVESTIGATOR and INVESTIGATOR’s team. Upon request of SPONSOR, INSTITUTION and/or INVESTIGATOR shall provide to SPONSOR copies of all materials, reports, correspondence, statements, forms and records which INSTITUTION and/or INVESTIGATOR receives, obtains or generates pursuant to any inspection in connection with the Study, or in connection with any matter that may affect INSTITUTION’s OR INVESTIGATOR’s performance of the Study, unless prohibited by law or court order and in line with INSTITUTION’s internal procedures.

Insurance and Indemnification. In accordance with Applicable Laws, the SPONSOR shall be liable, even without fault, for any damage incurred by a Study Participant or, in the case of death, his rightful claimants, that arises either in direct or indirect connection with the Study and shall provide compensation therefore. The SPONSOR shall enter into an insurance contract in accordance with Applicable Laws. Each PartyUpon request, the Sponsor shall provide the INSTITUTION and/or the INVESTIGATOR with a certificate of insurance. SPONSOR, INVESTIGATOR, and INSTITUTION, shall indemnify and hold harmless the other, its their agents and employees (collectively the “Other Party’s Indemnitees”) from any and all duly evidenced liabilities, claims, actions, or suits to the extent caused by its proven negligence or wrongful acts or omissions; or the proven negligence or wrongful acts or omissions of its agents or employees pertaining to the activities to be carried out pursuant to the obligations under this Agreement. Each Party shall promptly notify the other in writing of any such complaint, claim or injury relating to any loss subject to this indemnification. Neither Party shall indemnify and hold harmless the Other Party’s Indemnitees from liabilities arising out of negligence or wrongful acts or omissions of such Other Party’s Indemnitees. Without prejudice to SPONSOR’s no-fault liability towards Study Participants, the SPONSOR recognizes the need for the INVESTIGATOR to provide, at SPONSOR’s expense reasonable and necessary care for Study Participants involved in the Study with any adverse reaction in direct or indirect connection with the Study. In case of gross negligence or willful misconduct of the INVESTIGATOR and/or INSTITUTION, the SPONSOR may seek recourse against the INVESTIGATOR and/or the INSTITUTION. Except in case of gross negligence or wilful misconduct, [including breach of Sponsor Owned Inventions under Article 6.4.3, […][…] ], or where such limitation would be prohibited by mandatory provisions of law, the INSTITUTION’s and INVESTIGATOR’s total liability and indemnification obligation under this Agreement to the SPONSOR [and CRO jointly] under any and all circumstances for direct damages jointly shall under any and all circumstances not exceed (a) for damages covered under the civil liability insurance policy of the INSTITUTION and INVESTIGATOR in accordance with Article 7.6, the effective coverage under such insurance policy, and (b) for damages not covered under the civil liability insurance policy of the INSTITUTION and INVESTIGATOR (i) per occurrence an amount corresponding to the aggregated fees (excluding pass through costs) paid or/to be paid by the SPONSOR (and/or CRO) to the INSTITUTION and INVESTIGATOR for the Study under this Agreement; and (ii) in aggregate, an amount corresponding to [XX times] the aggregated fees paid/or to be paid by the SPONSOR (and/or CRO) to the INSTITUTION and INVESTIGATOR for the Study under this Agreement [or such other fixed amount as may be agreed upon by the Parties upon a case by case basis]. In any case abovementioned the INSTITUTION’s and INVESTIGATOR’s total liability and indemnification obligation under this Agreement to the SPONSOR [and CRO jointly] shall terminate upon the 10th (tenth) anniversary [or such other time as may be agreed upon by the Parties upon a case by case basis] of the end of the Study at the INSTITUTION in accordance with the Protocol. Notwithstanding anything to the contrary herein, [and except in case of gross negligence and/or wilful misconduct, [including breach of Sponsor Owned Inventions under Article 6.4.3, [...]], or where such limitation would be prohibited by mandatory provisions of law, in no event shall either Party be liable as between the Parties to the other for any indirect or consequential damages (including lost profits) to the extent not covered under the civil liability insurance policy arising out of the subject matter or performance of this Agreement. The INSTITUTION declares and INVESTIGATOR declare that it has they have a mandatory civil liability insurance policy in accordance with Applicable Laws which notably covers their own liability and –where applicable- the INSTITUTIONliability of their respective , its employees including the INVESTIGATOR and undertakes agents and undertake to maintain such insurance policy throughout the term of this Agreement and provides provide upon request of the SPONSOR any updated insurance certificate. The SPONSOR declares and warrants that it has a civil liability insurance policy which notably covers the SPONSOR and its employees and undertakes to maintain such insurance policy throughout the term of this Agreement and provides upon request of the INSTITUTION and the INVESTIGATOR any updated insurance certificate. All Parties shall promptly inform each other of any claims or imminent claims relating to the conduct of the Study. No admission or settlements in respect of the alleged liability of the other Party shall be made without the prior written approval of that Party (such consent not to be unreasonably withheld). For the avoidance of doubt, each Party shall be entitled to seek own counsel for any claims against itself or its employees. Notwithstanding the provisions set out in Article 7.4, nothing in this Article 7 shall operate so as to restrict or exclude the liability of any Party vis-à-vis the Study Participants in relation to their death or personal injury caused by the negligence of that Party or its agents or employees or to restrict or exclude any other liability of a Party which cannot be so restricted or excluded in law. INSPECTION AND AUDIT Upon request by any authorised officer or employee of any relevant regulatory agency, or other government authority, the INSTITUTION and the INVESTIGATOR are entitled and obliged to permit such officers or employees, at reasonable times, to have access to and inspect and verify any data records and reports in the INSTITUTION's and/or the INVESTIGATOR's possession, custody or control relating to the Study and shall submit such data records or reports to the said regulatory agency upon its request. In the case of a GCP inspection, the presence of a representative of SPONSOR is required unless otherwise stated by the SPONSOR. Unless prohibited by law or court order, the INSTITUTION and the INVESTIGATOR shall immediately inform the SPONSOR of any such inspection so as to allow the SPONSOR to be present to the inspection if he elects to be present, to allow the SPONSOR to prospectively review and comment on INSTITUTION’s and the INVESTIGATOR’s responses, and send to the SPONSOR a copy of any such inspection report. The SPONSOR shall be entitled to audit or have audited (i) the INSTITUTION's fulfilment of its obligations hereunder (such as, but not limited to invoiced costs and expenses), and/or (ii) the performance of the Study by the INVESTIGATOR. The SPONSOR shall inform the INSTITUTION and the INVESTIGATOR within a reasonable timeline compatible with the clinical activity of the INVESTIGATOR and INVESTIGATOR’s team. Upon request of SPONSOR, INSTITUTION and/or INVESTIGATOR shall provide to SPONSOR copies of all materials, reports, correspondence, statements, forms and records which INSTITUTION and/or INVESTIGATOR receives, obtains or generates pursuant to any inspection in connection with the Study, or in connection with any matter that may affect INSTITUTION’s OR INVESTIGATOR’s performance of the Study, unless prohibited by law or court order and in line with INSTITUTION’s internal procedures.

Insurance and Indemnification. In accordance with Applicable Laws, the SPONSOR shall be liableassume, even without fault, for the responsibility of any damage incurred by a Study Participant or, in the case of death, his rightful claimants, that arises either in direct or indirect connection with the Study experiments and shall provide compensation therefore. The SPONSOR shall enter into an insurance contract in accordance with Applicable Laws. Each Party, shall indemnify and hold harmless the other, its agents and employees (collectively the “Other Party’s Indemnitees”) from any and all duly evidenced liabilities, claims, actions, or suits to the extent caused by its negligence or wrongful acts or omissions; or the negligence or wrongful acts or omissions of its agents or employees pertaining to the activities to be carried out pursuant to the obligations under this Agreement. Each Party shall promptly notify the other in writing of any such complaint, claim or injury relating to any loss subject to this indemnification. Neither Party shall indemnify and hold harmless the Other Party’s Indemnitees from liabilities arising out of negligence or wrongful acts or omissions of such Other Party’s Indemnitees. Without prejudice to SPONSOR’s no-fault liability towards Study ParticipantsParticipant, the SPONSOR recognizes the need for the INVESTIGATOR to provide, at SPONSOR’s expense reasonable and necessary care for Study Participants involved in the Study with any adverse reaction in direct or indirect connection with the Study. In case of gross negligence or willful misconduct of the INVESTIGATOR and/or INSTITUTION, the SPONSOR may seek recourse against the INVESTIGATOR and/or the INSTITUTION. Except in case of gross negligence or wilful misconduct, [including breach of Sponsor Owned Inventions SPONSOR IP under Article 6.4.3., […][…] ], or where such limitation would be prohibited by mandatory provisions of law, the INSTITUTION’s total liability and indemnification obligation under this Agreement to the SPONSOR [and CRO jointly] under any and all circumstances for direct damages jointly shall under any and all circumstances not exceed (a) for damages covered under the civil liability insurance policy of the INSTITUTION in accordance with Article article 7.6, the effective coverage under such insurance policy, and (b) for damages not covered under the civil liability insurance policy of the INSTITUTION (i) per occurrence an amount corresponding to the aggregated fees (excluding pass through costs) paid or/to be paid by the SPONSOR (and/or CRO) to the INSTITUTION for the Study under this Agreement; and (ii) in aggregate, an amount corresponding to [XX times] 2 times the aggregated fees paid/or to be paid by the SPONSOR (and/or CRO) to the INSTITUTION for the Study under this Agreement [or such other fixed amount as may be agreed upon by the Parties upon a case by case basis]this. In any case abovementioned the INSTITUTION’s total liability and indemnification obligation under this Agreement to the SPONSOR [and CRO jointly] shall terminate upon the 10th (tenth) anniversary [or such other time as may be agreed upon by the Parties upon a case by case basis] of the end date of the Study at the INSTITUTION in accordance with the Protocol. Notwithstanding anything to the contrary herein, [and except in case of gross negligence and/or wilful misconduct, [including breach of Sponsor Owned Inventions SPONSOR IP under Article 6.4.3, [...]], or where such limitation would be prohibited by mandatory provisions of law, in no event shall either Party be liable as between the Parties to the other for any indirect or consequential damages (including lost profits) to the extent not covered under the civil liability insurance policy arising out of the subject matter or performance of this Agreement. The INSTITUTION declares that it has a mandatory civil liability insurance policy in accordance with Applicable Laws which notably covers the INSTITUTION, its employees including and the INVESTIGATOR (if not an employee) and undertakes to maintain such insurance policy throughout the term of this Agreement and provides upon request of the SPONSOR any updated insurance certificate. The SPONSOR declares and warrants that it has a civil liability insurance policy which notably covers the SPONSOR and its employees and undertakes to maintain such insurance policy throughout the term of this Agreement and provides upon request of the INSTITUTION any updated insurance certificate. Neither Party shall indemnify and hold harmless the Other Party’s Indemnitees from liabilities arising out of gross negligence or wrongful acts or omissions of such Other Party’s Indemnitees. All Parties shall promptly inform each other of any claims or imminent claims relating to the conduct of the Study. No admission or settlements in respect of the alleged liability of the other Party shall be made without the prior written approval of that Party (such consent not to the other Party. If one of the Parties admits liability, it shall be unreasonably withheld)given full conduct and control of any defense proceedings and negotiations concerning claims against the liable party. For the avoidance of doubt, each Party shall be entitled to seek own counsel for any claims against itself or its employees. Notwithstanding the provisions set out in Article 7.4, nothing in this Article 7 shall operate so as to restrict or exclude the liability of any Party vis-à-vis the Study Participants in relation to their death or personal injury caused by the negligence of that Party or its agents or employees or to restrict or exclude any other liability of a Party which cannot be so restricted or excluded in law. INSPECTION AND AUDIT Upon request by any authorised officer or employee of any relevant regulatory agency, or other government authority, the INSTITUTION and the INVESTIGATOR are entitled and obliged to permit such officers or employees, at reasonable times, to have access to and inspect and verify any data records and reports in the INSTITUTION's and/or the INVESTIGATOR's possession, custody or control relating to the Study and shall submit such data records or reports to the said regulatory agency upon its request. In the case of a GCP inspection, the presence of a representative of the SPONSOR is required unless otherwise stated by the SPONSOR. Unless prohibited by law or court order, the INSTITUTION and the INVESTIGATOR shall immediately inform the SPONSOR of any such inspection so as to allow the SPONSOR to be present to the inspection if he elects to be present, to allow the SPONSOR to prospectively review and comment on INSTITUTION’s responses, and send to the SPONSOR a copy of any such inspection report. The SPONSOR shall be entitled at any time to audit or have audited (i) the INSTITUTION's fulfilment of its obligations hereunder (such as, but not limited to invoiced costs and expenses), and/or (ii) the performance of the Study by the INVESTIGATOR. The SPONSOR shall inform the INSTITUTION within a reasonable timeline compatible with the clinical activity of the INVESTIGATOR and INVESTIGATOR’s team. Upon request of SPONSOR, INSTITUTION and/or INVESTIGATOR shall provide to SPONSOR copies of all materials, reports, correspondence, statements, forms and records which INSTITUTION and/or INVESTIGATOR receives, obtains or generates pursuant to any inspection in connection with the Study, or in connection with any matter that may affect INSTITUTION’s OR INVESTIGATOR’s performance of the Study, unless prohibited by law or court order and in line with INSTITUTION’s internal procedures.

Insurance and Indemnification. In accordance with Applicable LawsSponsor will provide clinical trial insurance of liability for damages for the Investigator, Institution and the SPONSOR shall be liable, even without fault, for any damage incurred by a Study Participant or, in the case of death, his rightful claimants, that arises either in direct or indirect connection with the Study and shall provide compensation therefore. The SPONSOR shall enter into an insurance contract Sponsor in accordance with Applicable Laws§ 52, par. Each Party3, letter f) Act on Pharmaceuticals. This policy duly covers, to the extent required by that legislation, compensable death of subject or compensation of the subject in case of injury resulting from and sustained in course of performance of the Study. A copy of the Certificate of Insurance is enclosed hereto as Exhibit C. In consideration of the performance of the obligations set forth herein by Investigator, Institution and any of their respective regents, trustees, directors, officers, agents or employees (collectively, “Indemnitees”), the Sponsor shall indemnify indemnify, defend and hold harmless the othereach Indemnitee from and against any loss, its agents and employees damage, cost or expense (including reasonable attorneys’ fees) (collectively the “Other Party’s IndemniteesLoss”) which may arise from any third party claim or suit alleging physical injury to a subject and seeking damages directly caused or contributed to by any substance or procedure administered in accordance with the Protocol; provided, however that: the Indemnitees shall have complied with the applicable laws and regulations (including without limitation, obtaining informed consents, Subject Authorizations, if separate from the Informed Consent, the EC and all duly evidenced liabilitiesother necessary approvals as stipulated by the applicable laws), claims, actions, the Protocol and all recommendations furnished by Sponsor or suits to CRO for the extent caused by its negligence or wrongful acts or omissionsuse and administration of any Study Drug(s); or the negligence or wrongful acts or omissions of its agents or employees pertaining to the activities to be carried out pursuant to the obligations under this Agreement. Each Party shall Sponsor is promptly notify the other notified in writing of any such complaint, claim or injury relating suit; the Indemnitees cooperate fully in the investigation and defense of any such claim or suit; Institution hereby acknowledges and agrees that the Sponsor retains the right to defend any claim or suit in any manner it deems appropriate, including the right to retain counsel of its choice; and Institution hereby acknowledges and agrees that the Sponsor shall have the sole right to settle the claim; provided, however, that Sponsor shall not admit fault on Indemnitees’ behalf without Indemnitees’ advance written permission. Notwithstanding the foregoing, the indemnification shall not extend to any loss subject Loss to this indemnification. Neither Party shall indemnify and hold harmless the Other Party’s Indemnitees extent such Loss arises from liabilities arising out of negligence the negligence, willful malfeasance or wrongful acts or omissions of such Other Party’s Indemnitees. Without prejudice to SPONSOR’s no-fault liability towards Study Participants, the SPONSOR recognizes the need for the INVESTIGATOR to provide, at SPONSOR’s expense reasonable and necessary care for Study Participants involved in the Study with malpractice by any adverse reaction in direct or indirect connection with the Study. In case of gross negligence or willful misconduct of the INVESTIGATOR and/or INSTITUTIONIndemnitees, it being understood that the SPONSOR may seek recourse against the INVESTIGATOR and/or the INSTITUTION. Except in case administration of gross negligence or wilful misconduct, [including breach of Sponsor Owned Inventions under Article 6.4.3, […][…] ], or where such limitation would be prohibited by mandatory provisions of law, the INSTITUTION’s total liability and indemnification obligation under this Agreement to the SPONSOR [and CRO jointly] under any and all circumstances for direct damages jointly shall under any and all circumstances not exceed (a) for damages covered under the civil liability insurance policy of the INSTITUTION in accordance with Article 7.6, the effective coverage under such insurance policy, and (b) for damages not covered under the civil liability insurance policy of the INSTITUTION (i) per occurrence an amount corresponding to the aggregated fees (excluding pass through costs) paid or/to be paid by the SPONSOR (and/or CRO) to the INSTITUTION for the Study under this Agreement; and (ii) in aggregate, an amount corresponding to [XX times] the aggregated fees paid/or to be paid by the SPONSOR (and/or CRO) to the INSTITUTION for the Study under this Agreement [or such other fixed amount as may be agreed upon by the Parties upon a case by case basis]. In any case abovementioned the INSTITUTION’s total liability and indemnification obligation under this Agreement to the SPONSOR [and CRO jointly] shall terminate upon the 10th (tenth) anniversary [or such other time as may be agreed upon by the Parties upon a case by case basis] of the end of the Study at the INSTITUTION substance in accordance with the Protocol. Notwithstanding anything to the contrary herein, [and except in case of gross Protocol shall not constitute negligence and/or wilful misconduct, [including breach of Sponsor Owned Inventions under Article 6.4.3, [...]], or where such limitation would be prohibited by mandatory provisions of law, in no event shall either Party be liable as between the Parties to the other malpractice for any indirect or consequential damages (including lost profits) to the extent not covered under the civil liability insurance policy arising out of the subject matter or performance purposes of this Agreement. The INSTITUTION declares Furthermore, an Indemnitee shall have the right to select and obtain representation by separate legal counsel; provided that it has a mandatory civil liability insurance policy in accordance with Applicable Laws which notably covers the INSTITUTION, its employees including the INVESTIGATOR and undertakes to maintain such insurance policy throughout the term of this Agreement and provides upon request of the SPONSOR any updated insurance certificate. The SPONSOR declares and warrants that it has a civil liability insurance policy which notably covers the SPONSOR and its employees and undertakes to maintain such insurance policy throughout the term of this Agreement and provides upon request of the INSTITUTION any updated insurance certificate. All Parties Indemnitee shall promptly inform each other of any claims or imminent claims relating to the conduct of the Study. No admission or settlements in respect of the alleged liability of the other Party shall be made without the prior written approval of that Party (such consent not to be unreasonably withheld). For the avoidance of doubt, each Party shall be entitled to seek own counsel for any claims against itself or its employees. Notwithstanding the provisions set out in Article 7.4, nothing in this Article 7 shall operate so as to restrict or exclude the liability of any Party vis-à-vis the Study Participants in relation to their death or personal injury caused by the negligence of that Party or its agents or employees or to restrict or exclude any other liability of a Party which cannot be so restricted or excluded in law. INSPECTION AND AUDIT Upon request by any authorised officer or employee of any relevant regulatory agency, or other government authority, the INSTITUTION and the INVESTIGATOR are entitled and obliged to permit such officers or employees, at reasonable times, to have access to and inspect and verify any data records and reports in the INSTITUTION's and/or the INVESTIGATOR's possession, custody or control relating to the Study and shall submit such data records or reports to the said regulatory agency upon its request. In the case of a GCP inspection, the presence of a representative of SPONSOR is required unless otherwise stated by the SPONSOR. Unless prohibited by law or court order, the INSTITUTION and the INVESTIGATOR shall immediately inform the SPONSOR of any such inspection so as to allow the SPONSOR to be present to the inspection if he elects to be present, to allow the SPONSOR to prospectively review and comment on INSTITUTION’s responses, and send to the SPONSOR a copy of any such inspection report. The SPONSOR shall be entitled to audit or have audited (i) the INSTITUTION's fulfilment of its obligations hereunder (such as, but not limited to invoiced bear all costs and expenses), and/or (ii) the performance of the Study by the INVESTIGATORexpense related to such separate representation. The SPONSOR shall inform the INSTITUTION within a reasonable timeline compatible with the clinical activity of the INVESTIGATOR and INVESTIGATOR’s team. Upon request of SPONSOR, INSTITUTION and/or INVESTIGATOR shall provide to SPONSOR copies of all materials, reports, correspondence, statements, forms and records which INSTITUTION and/or INVESTIGATOR receives, obtains or generates pursuant to CRO expressly disclaims any inspection liability in connection with the StudyStudy Drug(s), including any liability for any product claim arising out of a condition caused by or in connection with any matter allegedly caused by the administration of such Study Drug(s) except to the extent that may affect INSTITUTION’s OR INVESTIGATOR’s performance such liability is caused by the negligence, willful misconduct or breach of this Agreement by the Study, unless prohibited by law or court order and in line with INSTITUTION’s internal proceduresCRO. 15.