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. 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.

Appears in 5 contracts

Samples: Clinical Trial Agreement, Clinical Trials Agreement, Clinical Trials Agreement

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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. 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.

Appears in 4 contracts

Samples: Clinical Trial Agreement, Clinical Trial Agreement, Clinical Trial Agreement

Insurance and Indemnification. In accordance with Applicable Laws13.01. During the TERM OF THIS AGREEMENT and for a period of five (5) years after its expiration or earlier termination, EXIGENT and SBCL shall each obtain and/or maintain, respectively, at their sole cost and expense, product liability insurance or self-insurance that meets the SPONSOR following requirements: (a) the insurance shall insure the respective company against all liability related to the PRODUCT (whether the company's liability arises from the company's own conduct or by virtue of its participation in this Agreement), including liability for bodily injury, property damage, wrongful death, and any contractual indemnity obligations imposed by this Agreement; and (b) the insurance shall be liablein amounts, even without faultrespectively, for any damage incurred by a Study Participant or, that are reasonable and customary in the case U.S. clinical laboratory and medical device manufacturing companies of deathcomparable sizes and activities. 13.02. EXIGENT will indemnify and hold SBCL, his rightful claimantsits directors, that arises either officers, employees and representatives harmless from any claims, damages, or losses of a THIRD PARTY, including reasonable attorneys' fees (hereinafter "Losses"), arising from (i) the sale of PRODUCT, if such claims are the result of any negligent or wrongful act of EXIGENT or a defect in direct or indirect connection with the Study and shall provide compensation therefore. The SPONSOR shall enter into an insurance contract manufacturing by EXIGENT, including without limitation PRODUCT not manufactured by EXIGENT in accordance with Applicable Laws. Each PartyFDA approved specifications therefor, (ii) any misrepresentation or breach of warranty or covenant by EXIGENT, or (iii) the infringement of any THIRD PARTY patent through the manufacture, sale or use of the PRODUCT in the TERRITORY, unless such claims, damages or losses arise from or otherwise relate to SBCL's breach of its responsibilities under this Agreement or a negligent or wrongful act or any misrepresentation or breach of warranty or covenant by SBCL in which case BCL shall indemnify and hold harmless the otherEXIGENT, its agents directors, officers, employees, and employees (collectively representatives for any claims, damages, or losses, including reasonable attorneys' fees, incurred by it as a result of SBCL's negligent or wrongful acts. 13.03. Each party to this Agreement expects that all actions taken by the “Other Party’s Indemnitees”) from any parties in furtherance of this Agreement will be in compliance with a reasonable standard of care and all duly evidenced liabilities, claims, actions, or suits requirements of the law. 13.04. Any party of this Agreement which believes it is entitled 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 indemnity hereunder shall promptly notify the other in writing party from whom indemnity is sought of any such complaintclaim, claim lawsuit or injury relating proceeding believed to any loss subject give rise to this indemnificationa duty to indemnify. Neither Party The party from whom indemnity is sought shall indemnify have the right to assume and hold harmless control the Other Party’s Indemnitees from liabilities arising out defense of negligence said claim, lawsuit or wrongful acts proceeding (including the right to designate attorneys); provided that the claim, lawsuit or omissions proceeding may not be settled without approval of such Other Party’s Indemnitees. Without prejudice to SPONSOR’s no-fault liability towards Study Participantsthe indemnitee but if not settled because the indemnitee does not approve a proposed settlement, the SPONSOR recognizes the need indemnitor's liability 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 cash damages shall be prohibited by mandatory provisions of law, the INSTITUTION’s total liability and indemnification obligation under this Agreement limited to the SPONSOR [amount offered to 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 declined 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 employeesindemnitee. 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. Upon request by any authorised officer or employee of any relevant regulatory agency, or other government authorityforegoing, 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 party seeking indemnification may participate in the INSTITUTION's and/or the INVESTIGATOR's possessiondefense or settlement of such claim, custody lawsuit or control relating to the Study proceeding with counsel of its choice and shall submit such data records or reports to the said regulatory agency upon at 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 reportown expense. The SPONSOR shall be entitled parties agree 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 cooperate fully 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 each other in connection with the Studydefense, negotiation or in connection with settlement of any matter that may affect INSTITUTION’s OR INVESTIGATOR’s performance claim, lawsuit or proceeding. In the event the party from whom indemnity is sought declines to accept control of the Studydefense of the claim, unless prohibited by law lawsuit or court order proceeding, the party seeking indemnity may retain counsel at the expense of the party owing the indemnity and in line with INSTITUTION’s internal procedurescontrol the defense of the lawsuit, provided that the claim, lawsuit or proceeding may not be settled without the approval of the party from whom indemnity is sought.

Appears in 2 contracts

Samples: Distribution and Supply Agreement (Careside Inc), Distribution and Supply Agreement (Careside Inc)

Insurance and Indemnification. In accordance with Applicable Laws(a) Prior to the Effective Time, the SPONSOR Goldcorp shall be liable, even without fault, for any damage incurred by purchase customary “tail” policies of directors’ and officers’ liability insurance from a Study Participant or, reputable and financially sound insurance carrier and containing terms and conditions no less favourable in the case aggregate to the protection provided by the policies maintained by Goldcorp and its Subsidiaries which are in effect immediately prior to the Effective Date and providing protection in respect of deathclaims arising from facts or events which occurred on or prior to the Effective Time and Goldcorp will and will cause its Subsidiaries to, his rightful claimantsmaintain such “tail” policies in effect without any reduction in scope or coverage for six years from the Effective Time; provided, that arises either Goldcorp and its Subsidiaries shall not be required to pay any amounts in direct respect of such coverage prior to the Effective Time and provided further that the cost of such policies shall not exceed 250% of Goldcorp’s current annual aggregate premium for policies currently maintained by Goldcorp or indirect connection its Subsidiaries. (b) Goldcorp will, and will cause its Subsidiaries to, honour all rights to indemnification or exculpation now existing in favour of present and former employees, officers and directors of Goldcorp and its Subsidiaries under Law and under the articles or other constating documents of Goldcorp and/or its Subsidiaries or under any agreement or contract of any indemnified person with Goldcorp or with any of its Subsidiaries, and acknowledges that such rights shall survive the Study completion of the Plan of Arrangement, and, to the extent within the control of Goldcorp, Goldcorp shall ensure that the same shall not be amended, repealed or otherwise modified in any manner that would adversely affect any right thereunder of any such indemnified person and shall provide compensation therefore. The SPONSOR shall enter into an insurance contract continue in full force and effect in accordance with Applicable Laws. Each Partytheir terms for a period of not less than six years from the Effective Date. (c) From and following the Effective Time, shall indemnify Newmont will cause Goldcorp to comply with its obligations under Section 5.11(a) and hold harmless the otherSection 5.11(b). (d) If Newmont, its agents and employees (collectively the “Other Party’s Indemnitees”) from Goldcorp or 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 Subsidiaries 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 any of any such complaint, claim their respective successors 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 assigns (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; consolidates with or merges into any other person and is not a continuing or surviving corporation or entity of such consolidation or merger, or (ii) transfers all or substantially all of its properties and assets to any person, Newmont shall ensure that any such successor or assign (including, as applicable, any acquirer of substantially all of the properties and assets of the Company or its subsidiaries) assumes all of the obligations set forth in aggregate, an amount corresponding to [XX times] the aggregated fees paid/or to be paid by the SPONSOR this Section 5.11. (and/or CROe) to the INSTITUTION The provisions of this Section 5.11 are intended for the Study under this Agreement [benefit of, and shall be enforceable by, each insured or indemnified Person, his or her heirs and his or her legal representatives and, for such other fixed amount purpose, Goldcorp hereby confirms that it is acting as may be agreed upon by trustee on their behalf, and agrees to enforce 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 lawthis Section 5.11 on their behalf. Furthermore, in no event this Section 5.11 shall either Party be liable as between survive 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 termination of this Agreement and provides upon request as a result 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 occurrence of the INSTITUTION any updated insurance certificate. All Parties shall promptly inform each other Effective Date for a period 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. 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 proceduressix years.

Appears in 2 contracts

Samples: Arrangement Agreement (Goldcorp Inc), Arrangement Agreement (Newmont Mining Corp /De/)

Insurance and Indemnification. In accordance with Applicable Laws, the SPONSOR (a) Neither party shall be liableliable to the other, even without faultand both parties hereby waive all claims against the other, for any injury or damage incurred to any person or property in or about the Premises which is covered by a Study Participant orthe insurance required herein, in the case regardless 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, whether it is actually carried. (b) Tenant shall indemnify and hold Landlord harmless the other, its agents from and employees (collectively the “Other Party’s Indemnitees”) from defend Landlord against any and all duly evidenced liabilitiesclaims or liability for any injury or damage to any person or property whatsoever occurring in the Premises or any part thereof, claimswhether such injury or damage shall be caused in whole or in part by the act, actionsneglect, fault of, or suits omission of any duty with respect to the extent caused same by Tenant, its negligence agents, servants, employees or wrongful acts invitees. Tenant further agrees to indemnify and hold Landlord harmless from and defend Landlord against any and all claims by or omissions; on behalf of any person, firm or corporation, arising from the conduct or management of any work or thing whatsoever done by Tenant or from transactions of Tenant concerning the Premises or the negligence Building, and will further indemnify and hold Landlord harmless from and defend Landlord against any and all claims arising from any breach or wrongful acts default on the part of Tenant in the performance of any covenant or omissions agreement on the part of its agents or employees pertaining to the activities Tenant to be carried out performed pursuant to the obligations under terms of this AgreementLease or arising from any act or negligence of Tenant, or any of its agents, contractors, servants, employees or licensees, and from and against all costs, counsel fees, expenses and liabilities incurred in connection with any such claim or action proceeding brought thereon. Each Party shall promptly notify the other Furthermore, in writing case any action or proceeding be brought against Landlord by reason of any such complaintclaims or liabilities, claim Tenant agrees to defend such action or injury relating proceeding at Tenant’s sole expense by counsel reasonably satisfactory to Landlord. The provisions of this Section 10 shall survive the expiration or termination of this Lease with respect to any loss subject claims or liability occurring prior to this indemnification. Neither Party shall indemnify and hold harmless the Other Party’s Indemnitees from liabilities arising out of negligence such expiration 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 Protocoltermination. Notwithstanding anything to the contrary contained herein, [Tenant shall not be required to indemnify, defend or hold harmless Landlord from any claims, liabilities, damages, costs, counsel fees or expenses arising or resulting from the negligence or willful misconduct by Landlord or any of its agents, employees, servants, contractors or licensees. (c) Landlord shall indemnify and except hold Tenant harmless from and defend Tenant against any and all claims or liability for any injury or damage to any person or property whatsoever occurring in the Common Areas or any part thereof, whether such injury or damage shall be caused in whole or in part by the act, neglect, fault of, or omission of any duty with respect to the same by Landlord, its agents, servants, employees or invitees. Landlord further agrees to indemnify and hold Tenant harmless from and defend Tenant against any and all claims by or on behalf of any person, firm or corporation, arising from the conduct or management of any work or thing whatsoever done by Landlord or from transactions of Landlord concerning the Premises or the Building, and will further indemnify and hold Tenant harmless from and defend Tenant against any and all claims arising from any breach or default on the part of Landlord in the performance of any covenant or agreement on the part of Landlord to be performed pursuant to the terms of this Lease or arising from any act or negligence of Landlord, or any of its agents, contractors, servants, employees or licensees, and from and against all costs, counsel fees, expenses and liabilities incurred in connection with any such claim or action proceeding brought thereon. Furthermore, in case any action or proceeding be brought against Tenant by reason of gross negligence and/or wilful misconductany such claims or liabilities, [including breach of Sponsor Owned Inventions under Article 6.4.3, [...]], Landlord agrees to defend such action or where such limitation would be prohibited proceeding at Landlord’s sole expense by mandatory counsel reasonably satisfactory to Tenant. The provisions of lawthis Section 10 shall survive the expiration or termination of this Lease with respect to any claims or liability occurring prior to such expiration or termination. Notwithstanding anything to the contrary contained herein, Landlord shall not be required to indemnify, defend or hold harmless Tenant from any claims, liabilities, damages, costs, counsel fees or expenses arising or resulting from the negligence or willful misconduct by Tenant or any of its agents, employees, servants, contractors or licensees. Notwithstanding anything contained herein to the contrary, in no event shall either Party Landlord be liable as between the Parties to the other for any indirect special, consequential or consequential punitive damages hereunder. (including lost profitsd) to During the extent not covered under the civil liability insurance policy arising out Term of the subject matter or performance of this Agreement. The INSTITUTION declares that it has a mandatory civil liability insurance policy Lease, Tenant shall procure at its cost and expense and keep 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. 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 effect (i) the INSTITUTION's fulfilment commercial general liability insurance including contractual liability with a minimum combined single limit of its obligations hereunder liability of Three Million Dollars (such as, but not limited to invoiced costs and expenses$3,000,000.00), and/or (ii) casualty insurance for the performance full replacement cost of Tenant’s personal property and improvements to the Premises, (iii) worker’s compensation insurance, and (iv) business interruption insurance in an amount equal to one(1) years’ Rent hereunder. The commercial general liability insurance shall name Landlord and Landlord’s property manager as additional insureds, shall specifically include the liability assumed hereunder by Tenant and shall provide that it is primary insurance, and not excess over or contributory with any other valid, existing and applicable insurance in force for and on behalf of Landlord, and shall provide that Landlord shall receive ten (10) days written notice from the insurer prior to any cancellation or material change of coverage. Tenant shall deliver certificates of insurance to Landlord, on or before the Commencement Date, and prior to the expiration dates of expiring policies; and in the event Tenant shall fail to procure such insurance, or to deliver such certificates, Landlord may, at its option, procure same for the account of Tenant and the cost thereof shall be paid to Landlord as Additional Charges within five (5) days after delivery to Tenant of a statement therefore. (e) During the Term of the Study Lease, Landlord shall procure at its cost and expense and keep in effect (i) commercial general liability insurance including contractual liability with a minimum combined single limit of Three Million Dollars ($3,000,000.00), (ii) worker’s compensation insurance if required by state law and (iii) casualty insurance for the INVESTIGATOR. The SPONSOR shall inform the INSTITUTION within a reasonable timeline compatible with the clinical activity full replacement cost of the INVESTIGATOR Building and INVESTIGATOR’s teamrelated improvements. Upon Landlord shall deliver policies of such insurance or certificates thereof to Tenant upon written 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 proceduresTenant.

Appears in 2 contracts

Samples: Lease Agreement, Lease Agreement (SP Plus Corp)

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, (a) Landlord shall indemnify and hold Tenant harmless the other, its agents from and employees against (collectively the “Other Party’s Indemnitees”i) from any and all duly evidenced claims or liability for any injury or damage to any person or property including any reasonable attorney’s fees (but excluding any consequential damages or loss of business in all circumstances except where such claims or liability are caused by the willful misconduct of Landlord) occurring in, on, or about the Project to the extent such injury or damage is caused by the negligence or willful misconduct of Landlord, its agents, servants, contractors, employees (collectively, including Landlord, “Landlord Parties”) and (ii) any and all claims, losses, or liabilities, claimsincluding damage to Tenant’s property fees (but excluding any consequential damages or loss of business) arising from any breach of this Lease by Landlord. (b) Landlord shall not be liable to Tenant, actionsand Tenant hereby waives all claims against Landlord Parties for any injury or damage to any person or property in or about the Premises by or from any cause whatsoever (other than the negligence or willful misconduct of Landlord Parties, including Landlord’s negligence or willful misconduct as related to construction or property management), and without limiting the generality of the foregoing, whether caused by water leakage of any character from the roof, walls,, or suits other portion of the Premises or the Building, or caused by gas, fire, oil, electricity, or any cause whatsoever, in, on, or about the Premises, the Building or any part thereof (other than that caused by the negligence or willful misconduct of Landlord Parties). Tenant acknowledges that any casualty insurance carried by Landlord will not cover loss of income to Tenant or damage to the alterations in the Premises installed by Tenant or Tenant’s personal property located within the Premises. Tenant shall be required to maintain the insurance described in Paragraph 10(d) during the Term. In the event of a discrepancy between the terms of this paragraph and the terms of Paragraph 39 of the Lease concerning Hazardous Substance liability, the latter shall control. Nothing in this Paragraph 10(b) is intended to nor shall it be deemed to override the provisions of Paragraph 11. (c) Except 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 INSTITUTIONLandlord Parties, the SPONSOR may seek recourse Tenant shall indemnify and hold Landlord harmless from and defend Landlord 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 claims or liability 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 injury or damage to any person or property whatsoever: (i) per occurrence an amount corresponding to occurring in or on 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 AgreementPremises; and (ii) in aggregateoccurring in, an amount corresponding to [XX times] the aggregated fees paid/on, or to be paid by the SPONSOR (and/or CRO) to the INSTITUTION for the Study under this Agreement [or such about any 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] portion 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) Project to the extent not covered under the civil liability insurance policy arising out of the subject matter such injury 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 damage 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 or willful misconduct by Tenant, its agents, servants, employees, or invitees (collectively, including Tenant, “Tenant Parties”), or (iii) arising from any breach of that Party this Lease by Tenant. Tenant further agrees to indemnify and hold Landlord harmless from, and defend Landlord against, any and all claims, losses, or its agents or employees or liabilities (including damage to restrict or exclude Landlord’s property) arising from (x) any other liability breach of a Party which cannot be so restricted or excluded in law. Upon request this Lease by any authorised officer or employee Tenant and/or (y) the conduct of any relevant regulatory agencywork or business of Tenant Parties in or about the Project, 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 asincluding, but not limited to invoiced costs any release, discharge, storage or use of any hazardous substance, hazardous waste, toxic substance, oil, explosives, asbestos, or similar material. In the event of a discrepancy between the terms of this Paragraph and expensesthe terms of Paragraph 39 of the Lease concerning Hazardous Substance liability, the latter shall control. Nothing in this Paragraph 10(c) is intended to nor shall it be deemed to override the provisions of Paragraph 11. (d) Tenant shall procure at its cost and expense and keep in effect during the Term the following insurance: (1) commercial general liability insurance including contractual liability with a minimum combined single limit of liability of Three Million Dollars ($3,000,000). Such insurance shall name Landlord as an additional insured, and/or shall specifically include the liability assumed hereunder by Tenant, and is intended to be primary insurance, and not excess over or contributory with any other valid, existing, and applicable insurance in force for or on behalf of Landlord, and shall provide that Landlord shall receive thirty (30) days’ written notice from the insurer prior to any cancellation or change of coverage; (2) “all risk” property insurance (including, without limitation, boiler and machinery (if applicable); sprinkler damage, vandalism and malicious mischief) on any Alterations installed in the Premises by or on behalf of Tenant all leasehold improvements installed in the Premises by Tenant at its expense, and all of Tenant’s personal property, such insurance to include a building ordinance provision (as to those Alterations for which such a provision will apply). Such insurance shall be an amount equal to full replacement cost of the aggregate of the foregoing and shall provide coverage comparable to the coverage in the standard ISO All Risk form, when such form is supplemented with the coverages required above, and shall name Landlord as a loss payee; (3) worker’s compensation insurance; and (4) such other insurance as may be required by the law. All insurance policies required under this Paragraph 10(d) shall be issued by carriers each with a Best’s Insurance Reports policy holder’s rating of not less than A and a financial size category, of not less than Class VIII. Tenant shall deliver policies of such insurance or certificates thereof to Landlord on or before the Commencement Date, and thereafter at any time and from time-to-time within ten (10) business days after written request from Landlord. In the event Tenant shall fail to procure and keep such insurance in full force and effect during the Term, or to deliver such policies or certificates within said time frame, Landlord may, at its option, procure same for the account of Tenant, and the cost thereof shall be paid to Landlord as Additional Rent within five (5) business days after delivery to Tenant of bills therefor. (e) The provisions of this Paragraph 10 shall survive the expiration or termination of this Lease with respect to any claims or liability occurring prior to such expiration or termination. (f) Landlord shall maintain insurance on the Project against fire and risks covered by “all risk” (excluding earthquake and flood, though Landlord, at its option, may include this coverage provided it can be obtained at commercially reasonable rates) on a 100% of “replacement cost” basis (though reasonable deductibles may be included under such coverage). Landlord’s insurance: (i) shall cover the Building; (ii) not cover any Alterations installed in the performance Premises by or on behalf of the Study by the INVESTIGATOR. The SPONSOR Tenant; (iii) shall inform the INSTITUTION within have a reasonable timeline compatible with the clinical activity of the INVESTIGATOR building ordinance provision; and INVESTIGATOR’s team. Upon request of SPONSOR, INSTITUTION and/or INVESTIGATOR (iv) shall provide to SPONSOR copies for rental interruption insurance covering a period of all materials, reports, correspondence, statements, forms and records which INSTITUTION and/or INVESTIGATOR receives, obtains or generates pursuant twelve (12) full months. In no event shall Landlord agree to any inspection co-insurance obligations under any such policies (beyond standard deductibles). Landlord shall also maintain commercial general liability insurance including, without limitation, contractual liability coverage (or with contractual liability endorsement) on an occurrence basis in connection amounts not less than Three Million Dollars ($3,000,000) per occurrence with respect to bodily injury or death and property damage. Notwithstanding the Studyforegoing obligations of Landlord to carry insurance, Landlord may modify the foregoing coverages if and to the extent it is commercially reasonable to do so. If Tenant disagrees that such coverage is commercially reasonable or believes it is not necessary, then Tenant shall have the right to submit such matter to arbitration. In the event, however, that Tenant prevails in connection with any matter that may affect INSTITUTION’s OR INVESTIGATOR’s performance said arbitration and deductibles are increased, then Tenant shall be fully responsible for covering such increased deductibles in the event of the Study, unless prohibited by law or court order and in line with INSTITUTION’s internal procedurescasualty.

Appears in 2 contracts

Samples: Lease Agreement (Upwork Inc.), Lease Agreement (Upwork Inc.)

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”a) from any and all duly evidenced liabilities, claims, actions, or suits Except 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 Tenant Parties (as defined in case of gross negligence Paragraph 10(c) below) or wilful misconduct, [including Tenant's breach of Sponsor Owned Inventions under Article 6.4.3this Lease, […][…] ], or where such limitation would be prohibited by mandatory provisions of law, the INSTITUTION’s total liability Landlord shall indemnify and indemnification obligation under this Agreement to the SPONSOR [hold Tenant harmless from and CRO jointly] under defend Tenant against any and all circumstances claims or liability 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 injury or damage to the aggregated any person or property including any reasonable attorney's fees (but excluding pass through costsany consequential damages or loss of business) paid or/to be paid by the SPONSOR (and/or CRO) to the INSTITUTION for the Study under this Agreement; and (ii) in aggregateoccurring in, 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, [...]]on, or where such limitation would be prohibited by mandatory provisions of law, in no event shall either Party be liable as between about the Parties to the other for any indirect or consequential damages (including lost profits) Project to the extent not covered under the civil liability insurance policy arising out of the subject matter such injury 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 damage is caused by the negligence or willful misconduct of that Party Landlord, its agents, servants, contractors, employees (collectively, including Landlord, "Landlord Parties") or its agents or employees or to restrict or exclude any other liability Landlord's breach of a Party which canthis Lease. (b) Landlord shall not be so restricted liable to Tenant, and Tenant hereby waives all claims against Landlord Parties for any injury or excluded damage to any person or property in law. Upon request or about the Premises by or from any authorised officer cause whatsoever (other than the negligence or employee willful misconduct of Landlord Parties, including Landlord's negligence or willful misconduct as related to construction or property management), and without limiting the generality of the foregoing, whether caused by water leakage of any relevant regulatory agencycharacter from the roof, walls, basement, or other government authorityportion of the Premises or the Building, or caused by gas, fire, oil, electricity, or any cause whatsoever, in, on, or about the Premises, the INSTITUTION and Building or any part thereof (other than that caused by the INVESTIGATOR are entitled and obliged negligence or willful misconduct of Landlord Parties). Tenant acknowledges that any casualty insurance carried by Landlord will not cover loss of income to permit such officers Tenant or employees, at reasonable times, damage to have access to and inspect and verify any data records and reports the alterations in the INSTITUTIONPremises installed by Tenant or Tenant's and/or personal property located within the INVESTIGATOR's possession, custody or control relating Premises. Tenant shall be required to maintain the insurance described in Subparagraph 10(d) below during the Term. (c) Except 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 extent caused by the SPONSOR. Unless prohibited by law negligence or court orderwillful misconduct of Landlord Parties or Landlord's breach of this Lease, the INSTITUTION Tenant shall indemnify and the INVESTIGATOR shall immediately inform the SPONSOR of hold Landlord harmless from and defend Landlord against any such inspection so as and all claims or liability for any injury or damage 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 person or have audited property whatsoever; (i) occurring in or on the INSTITUTION's fulfilment of its obligations hereunder (such as, but not limited to invoiced costs and expenses), and/or Premises; or (ii) the performance occurring in, on, or about any other portion of the Study Project to the extent such injury or damage shall be caused 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 SPONSORnegligence or willful misconduct by Tenant, INSTITUTION and/or INVESTIGATOR shall provide to SPONSOR copies of all materialsits agents, 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.servants,

Appears in 1 contract

Samples: Sublease (Cosine Communications Inc)

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. 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.

Appears in 1 contract

Samples: Clinical Study Site 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, (a) Customer shall indemnify and hold harmless the otherWuXi AppTec, its officers, directors, agents and employees (collectively the “Other Party’s Indemnitees”) from and against any and all duly evidenced liabilitieslosses, costs, damages and/or expenses (including, without limitation, reasonable costs of counsel), incurred by any such indemnitee as a result of or in connection with any claim by any third party 1) for injury (physical, emotional, psychological or other) or death of any person or physical damage to any property arising out of [*], provided such claim, injury, death or property damage is not the result of WuXi AppTec's [*] or breach of this Agreement in carrying out its obligations under this Agreement or any Work Order, or 2) alleging WuXi AppTec’s [*], or Customer intellectual property rights that are [*], infringes any rights (including, without limitation, any intellectual or industrial property rights) vested in any third party (whether or not the Customer knows or ought to have known about the same). In the event a third party claim is asserted against WuXi AppTec for which indemnification is required hereunder, WuXi AppTec shall give Customer prompt written notice thereof. WuXi AppTec shall cooperate with Customer, at Customer’s cost and expense, in the defense of any such claim. Customer shall have the sole right to defend and/or settle such a claim, including selecting counsel of its choice. Costs, expenses and fees incurred by WuXi AppTec and as to which WuXi AppTec has a right of indemnification hereunder shall be periodically reimbursed by Customer as incurred. (b) WuXi AppTec shall indemnify and hold Customer harmless against all claims, actions, costs, expenses (including court costs and reasonable attorney’s fees) or suits other liabilities (collectively, “Losses”) whatsoever to, from or in favor of third parties, to the extent such Losses are caused or contributed by 1) WuXi AppTec’s performance of the Services (except to the extent resulting from WuXi AppTec’s use of [*]); 2) the [*] or breach of this Agreement of WuXi AppTec or any of its negligence employees or wrongful acts agents in the performance of Services. WuXi AppTec’s liability to indemnify Customer shall be reduced to the extent that such Losses were caused or omissions; contributed to by the [*] or breach of this Agreement by Customer. In the negligence event a third party claim is asserted against Customer for which indemnification is required hereunder, Customer shall give WuXi AppTec prompt written notice thereof. Customer shall cooperate with WuXi AppTec, at WuXi AppTec’s cost and expense, in the defense of any such claim. WuXi AppTec shall have the sole right to defend and/or settle such a claim, including selecting counsel of its choice. Costs, expenses and fees incurred by Customer and as to which Customer has a right of indemnification hereunder shall be periodically reimbursed by WuXi AppTec as incurred. (c) Both Parties shall maintain a separate policy or wrongful policies of insurance in the amount of at least [*] per occurrence and [*] in the aggregate for insuring against liability which may be imposed arising out of its acts or omissions to include: 1) comprehensive general liability providing coverage for personal injury, bodily injury, property damage; and 2) professional liability. In addition, Customer shall maintain Product Liability insurance in the aggregate of at least [*]. As soon as practicable following the execution of this Agreement, each Party shall cause its agents or employees pertaining insurer(s) to list the other Party as an additional insured on the insurance policies required hereby and shall deliver to the activities to be carried out pursuant to other Party a certificate(s) of insurance Party evidencing the obligations applicable coverage(s). (d) WuXi AppTec’s sole liability for any loss or damage suffered by Customer as a result of any breach of the Agreement or of any other liability of WuXi AppTec in respect of the Services conducted under this AgreementExhibit 10.68 Agreement or any Work Order (including without limitation the production and/or supply of the Product) shall be limited to [*] in an amount not exceed [*]. Each Party This limitation 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 not apply in the Study with any adverse reaction in direct or indirect connection with event such damages were caused by the Study. In case of gross negligence or willful misconduct of the INVESTIGATOR and/or INSTITUTIONWuXi AppTec, the SPONSOR may seek recourse against the INVESTIGATOR and/or the INSTITUTION. WuXi AppTec’s breach of [*] set forth in Section [*] or its [*] set forth in [*] Section [*]. (e) Except in case for losses or damages arising from breach of [*] obligations or from a Party’s 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 willful misconduct neither Party shall be made without the prior written approval of that Party (liable hereunder for any special, indirect, incidental, consequential or punitive damages, even if 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 employeeshave been advised of the possibility of such potential damages. Notwithstanding . (f) The Parties hereto acknowledge that the provisions limitations of liabilities set out in Article 7.4, nothing forth in this Article 7 shall operate so as to restrict or exclude Section 9 reflect the liability allocation of any Party vis-à-vis risk set forth in this agreement and that the Study Participants in relation to their death or personal injury caused by the negligence Parties would not enter into this agreement without these limitations 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. 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 proceduresliability.

Appears in 1 contract

Samples: Cell Therapy Development, Manufacturing and/or Tissue Processing Terms and Conditions (Newlink Genetics Corp)

Insurance and Indemnification. In accordance with Applicable Laws3.1 Prior to starting the work to be performed under this agreement, the SPONSOR subcontractor shall be liableobtain and pay for Employer’s Liability or Workmen’s compensation insurance as required by state law, even without faultand also Public Liability and Property Damage Insurance satisfactory to contractor. Subcontractor shall furnish satisfactory evidence to contractor that it has complied with these requirements. A sample insurance certificate with minimum requirements is attached. 3.2 Subcontractor shall defend, 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 otherContractor, its agents Contractors subsidiaries, agents, officers, successors and employees (collectively from and against all claims, damages, losses and expenses, including attorneys’ fees, arising out of or resulting from the “Other Partyperformance of the work or connected in any way to the performance of subcontractors work under this agreement, provided that any such claim, damage, loss or expense is caused in whole or in part by any negligent act or omission of the Subcontractor, anyone directly or indirectly employed by the Subcontractor, or anyone whose acts the Subcontractor may be liable, including but not limited to any such claim, damage, loss or expense that: 3.2.1 Is attributable to bodily injury, sickness, disease or death, or to injury to or destruction of tangible and intangible property, including loss of use there from; or 3.2.2 Is alleged to have arisen out of any breach of Subcontractor. 3.3 This indemnification agreement shall not be limited in way by any limitations on the amount or type of damages, compensation or benefits payable by or for the Subcontractor under workers’ compensation acts, disability benefit acts, or other employee benefit acts, and Subcontractor expressly waives the benefits of any liability cap recognized by any local, state or federal laws 3.4 The Subcontractor’s Indemnitees”) from indemnification obligations under this agreement are not limited by the insurance requirements of this Agreement. In addition to the indemnification obligations hereunder, The Subcontractor waives, and shall cause each of its subcontractors of every tier to waive, any rights under any workers compensation, disability, or other employee benefit act, that any of them may have to limit the amount of damages, losses, or obligations which may be recoverable under this indemnification or under contribution acts or other applicable laws. 3.5 Subcontractor shall indemnify and hold the Contractor and the Owner harmless for any and all duly evidenced liabilitiesliens, encumbrances, claims, actionsobligations or liabilities (“Liens”) which may be asserted against the Contractor, Owner or suits to the extent caused their property by its negligence reason of or wrongful acts or omissions; or the negligence or wrongful as a result of any acts or omissions of its agents the Subcontractor, his employees, representatives, licensees, or employees pertaining subcontractors, in connection with or related 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 Contractor may withhold and retain from time to time out of any moneys due the subcontractor amounts sufficient fully to obtain the release or satisfaction of such a Lien and to recover any loss or damage which the Contractor sustains, or may sustain, as a result of any such Liens. 3.6 The Subcontractor assumes the risk of and liability for loss or damage to the Subcontractor’s materials, tools or equipment. 3.7 In the event that the Subcontractor contracts with any other person for the performance of any of the Subcontractor Work (a “lower Tier Subcontract”), each such “Lower Tier Subcontract” shall include the indemnification of the Contractor, the Owner, and their respective officers, directors, agents and employees, on the terms provided in this paragraph. 3.8 The subcontractor acknowledges that it has a mandatory civil liability insurance policy in accordance with Applicable Laws which notably covers appropriately trained employees and/or subcontractors who will complete 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 necessary installation 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 repair work 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 performed under 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. 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 proceduresagreement.

Appears in 1 contract

Samples: Subcontract 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 intravenous therapy services and provides upon request products under this Agreement. PROVIDER shall submit to FACILITY prior to the effective date of the SPONSOR any updated this Agreement, a certificate of insurance certificate. The SPONSOR declares issued by an insurer authorized to conduct insurance business in this state 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. 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.

Appears in 1 contract

Samples: Preferred Provider Agreement (Pharmerica Inc)

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, (a) Customer shall indemnify and hold harmless the otherWuXi AppTec, its officers, directors, agents and employees (collectively the “Other Party’s Indemnitees”) from and against any and all duly evidenced liabilitieslosses, costs, damages and/or expenses (including, without limitation, reasonable costs of counsel), incurred by any such indemnitee as a result of or in connection with any claim by any third party 1) for injury (physical, emotional, psychological or other) or death of any person or physical damage to any property arising out of Customer’s (or its affiliates’ or licensees’s) testing, development, manufacture, sale or other use or distribution of any material or product (including the Product) which is the result of Services performed by WuXi AppTec under the Agreement, provided such claim, injury, death or property damage is not the result of WuXi AppTec's negligence or reckless or willful misconduct or breach of this Agreement in carrying out its obligations under this Agreement or any Work Order, or 2) alleging WuXi AppTec’s use of Customer’s Starting Materials, or Customer intellectual property rights that are supplied to Wuxi AppTec by Customer, in accordance with the applicable Work Order and Customer’s instructions, infringes any rights (including, without limitation, any intellectual or industrial property rights) vested in any third party (whether or not the Customer knows or ought to have known about the same). In the event a third party claim is asserted against WuXi AppTec for which indemnification is required hereunder, WuXi AppTec shall give Customer prompt written notice thereof. WuXi AppTec shall cooperate with Customer, at Customer’s cost and expense, in the defense of any such claim. Customer shall have the sole right to defend and/or settle such a claim, including selecting counsel of its choice. Costs, expenses and fees incurred by WuXi AppTec and as to which WuXi AppTec has a right of indemnification hereunder shall be periodically reimbursed by Customer as incurred. (b) WuXi AppTec shall indemnify and hold Customer harmless against all claims, actions, costs, expenses (including court costs and reasonable attorney’s fees) or suits other liabilities (collectively, “Losses”) whatsoever to, from or in favor of third parties, to the extent such Losses are caused or contributed by 1) WuXi AppTec’s performance of the Services (except to the extent resulting from WuXi AppTec’s use of any intellectual property rights or materials supplied by Customer in accordance with Customer’s specific instruction); 2) the negligence, reckless or willful misconduct or breach of this Agreement of WuXi AppTec or any of its negligence employees or wrongful acts agents in the performance of Services. WuXi AppTec’s liability to indemnify Customer shall be reduced to the extent that such Losses were caused or omissions; contributed to by the act, direction, negligence, reckless or willful misconduct or breach of this Agreement by Customer. In the negligence event a third party claim is asserted against Customer for which indemnification is required hereunder, Customer shall give WuXi AppTec prompt written notice thereof. Customer shall cooperate with WuXi AppTec, at WuXi AppTec’s cost and expense, in the defense of any such claim. WuXi AppTec shall have the sole right to defend and/or settle such a claim, including selecting counsel of its choice. Costs, expenses and fees incurred by Customer and as to which Customer has a right of indemnification hereunder shall be periodically reimbursed by WuXi AppTec as incurred. (c) Both Parties shall maintain a separate policy or wrongful policies of insurance in the amount of at least $1 million per occurrence and $3 million in the aggregate for insuring against liability which may be imposed arising out of its acts or omissions to include: 1) comprehensive general liability providing coverage for personal injury, bodily injury, property damage; and 2) professional liability. In addition, Customer shall maintain Product Liability insurance in the aggregate of at least $5 million. As soon as practicable following the execution of this Agreement, each Party shall cause its agents or employees pertaining insurer(s) to list the other Party as an additional insured on the insurance policies required hereby and shall deliver to the activities to other Party a certificate(s) of insurance Party evidencing the applicable coverage(s). (d) WuXi AppTec’s sole liability for any loss or damage suffered by Customer as a result of any breach of the Agreement or of any other liability of WuXi AppTec in respect of the Services conducted under this Agreement or any Work Order (including without limitation the production and/or supply of the Product) shall be carried out pursuant limited to the obligations payment by WuXi AppTec in an amount not exceed the Price of the non-conforming Services under this Agreementwhich such liability arises. Each Party This limitation 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 not apply in the Study with any adverse reaction in direct or indirect connection with event such damages were caused by the Study. In case of gross negligence or willful misconduct of the INVESTIGATOR and/or INSTITUTIONWuXi AppTec, the SPONSOR may seek recourse against the INVESTIGATOR and/or the INSTITUTION. WuXi AppTec’s breach of its confidentiality obligations set forth in Section 10 or its indemnification obligations set forth in this Section 9. (e) Except in case for losses or damages arising from breach of confidentiality obligations or from a Party’s 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 willful misconduct neither Party shall be made without the prior written approval of that Party (liable hereunder for any special, indirect, incidental, consequential or punitive damages, even if 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 employeeshave been advised of the possibility of such potential damages. Notwithstanding . (f) The Parties hereto acknowledge that the provisions limitations of liabilities set out in Article 7.4, nothing forth in this Article 7 shall operate so as to restrict or exclude Section 9 reflect the liability allocation of any Party vis-à-vis risk set forth in this agreement and that the Study Participants in relation to their death or personal injury caused by the negligence Parties would not enter into this agreement without these limitations 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. 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 proceduresliability.

Appears in 1 contract

Samples: Cell Therapy Development, Manufacturing and/or Tissue Processing Terms and Conditions (Newlink Genetics Corp)

Insurance and Indemnification. In accordance with Applicable Laws17.1 Operator shall provide and maintain, at its own expense which is not reimbursable, the SPONSOR following types and amounts of insurance, during the term of this Contract: Comprehensive General (Public) Liability to include (but not limited to) the following: Combined Single Limit for Bodily Injury and Property Damage: $3,000,000 a) Premises/operations b) Independent contractor c) Personal injury liability d) Contractual liability (insuring Indemnity provision within this contract) the above $3,000,000 public liability and property damage shall be liableprimary coverage. Any expense for deductible loss sustained by the Operator where such insurance policy includes a deductible limit approved by the Commission is reimbursable. The procuring of such policies of insurance shall not be construed to be a limitation upon Operator's liability or as a full performance on its part of the indemnification provisions of the Contract. Operator's obligations to the Commission are, even without faultnotwithstanding said policy of insurance, for the full and total amount of any damage incurred damage, injury or loss as provided under the terms of the Contract. 17.2 Prior to the Contract effective date, Operator shall furnish to Commission certificates or copies of the Policies, plainly and clearly evidencing required insurance and thereafter new certificates prior to the expiration date of any prior certificate. Operator understands that it is its sole responsibility to provide this necessary information and that failure to comply timely with the requirements of this Article shall be a cause for termination of this Contract, under the provisions of the termination clause. 17.3 Insurance required herein shall be issued by a Study Participant orcompany or companies of sound and adequate financial responsibility and authorized to do business in the State of Georgia. All policies shall be subject to examination and approval by the Commission for their adequacy as to form, content, form of protection, and providing company. 17.4 Insurance required by this Contract for the Commission, as additional insured shall be primary insurance and not contributing with any other insurance available to Commission, under any third party liability policy. 17.5 Operator further agrees that with respect to the above-required insurance, the Commission shall: a. Be named as additional insured/or an insured, as its interest may appear or be provided with a waiver of subrogation. b. Be provided with thirty (30) days advance notice, in writing, of or material change. If either requirement under subsection a. or b. requires the case payment of death, his rightful claimants, additional premium by Operator it may present such information to the Commission for its reconsideration. Commission will not be responsible for any of Operator's insurance costs. 17.6 The Commission shall stand indemnified by the Operator as provided herein. It is expressly understood and agreed by and between the parties that arises either in direct or indirect connection with the Study Operator is and shall provide compensation therefore. The SPONSOR be deemed to be an independent contractor responsible to all persons for its respective acts or omissions, and the Commission shall enter into an insurance contract in accordance with Applicable Laws. Each Partyno way be responsible therefor. 17.7 Operator shall indemnify, shall indemnify defend, save and hold harmless Augusta, Georgia, the otherCommission, its agents their officers, directors, agents, and employees (collectively the “Other Party’s Indemnitees”) from any and all duly evidenced claims, liabilities, claimsdamages, actionslosses, suits, fines, penalties, demands and expenses, including costs of suit and attorney fees, which any or all of them may hereafter incur, be responsible for, or suits pay out as a result of bodily injury (including death) to any person or damage to any property or person, arising out of the Premises or any acts or omissions of the Operator, its agents, guests, invitees, employees, or contractors in connection with the Operator's use of the Premises or its operations at the Airport, except 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 sole gross negligence or willful misconduct of the INVESTIGATOR and/or INSTITUTIONCommission or its officers, directors, agents or employees. Contract 17.8 Upon the filing with the Commission of a claim for damages arising out of incidents for which Operator herein agrees to indemnify, defend, save and hold harmless Augusta, Georgia, the SPONSOR may seek recourse Commission shall notify the Operator of such claim. Any final judgment rendered against Augusta Georgia for any cause for which the Operator is liable hereunder shall be conclusive 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 Operator as to liability and indemnification obligation under this Agreement to amount, provided 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 Commission has notified the civil liability insurance policy Operator 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 claim 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. provided above. 17.9 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 lawthis Contract, in no event shall will either Party party or any of its shareholders, members, officers, directors, employees or personnel be liable as between the Parties to the other for any indirect liability or claim for punitive, special, exemplary, liquidated, indirect, or consequential damages (including lost profits) to the extent not covered under the civil liability insurance policy arising out or for loss of the subject matter profits or performance of this Agreementbusiness. 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. 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.17.10

Appears in 1 contract

Samples: Parking Management Contract

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”a) from any and all duly evidenced liabilities, claims, actions, or suits Except 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 willful misconduct of any such complaintTenant Parties, claim or injury relating to any loss subject to this indemnification. Neither Party Landlord shall indemnify and hold Tenant harmless from and against any and all claims or liability for any injury or damage to any person or property including any reasonable attorney’s fees (but excluding any consequential damages or loss of business) occurring in, on, or about the Other Party’s Indemnitees from liabilities arising out of negligence Project to the extent such injury or wrongful acts or omissions of such Other Party’s Indemnitees. Without prejudice to SPONSOR’s no-fault liability towards Study Participants, damage is caused by 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 Landlord, its employees, its property manager, or its property manager’s employees; provided, however, that the INVESTIGATOR and/or INSTITUTIONforegoing indemnity shall not include claims or liability to the extent waived by Tenant pursuant to Paragraph 10(b) below. Further, (1) in the event of a discrepancy between the terms of this Paragraph and the terms of Paragraph 39 of this Lease concerning Hazardous Substances liability, the SPONSOR may seek recourse against the INVESTIGATOR and/or the INSTITUTION. Except latter shall control; and (2) nothing 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 Paragraph 10 (a) for damages covered under is intended to nor shall it be deemed to override the civil liability insurance policy provisions of the INSTITUTION in accordance with Article 7.6, the effective coverage under such insurance policy, and Paragraph 11. (b) Landlord shall not be liable to Tenant, and Tenant hereby waives all claims against Landlord Parties for damages not covered under any injury or damage to any person or property in or about the civil liability insurance policy Premises by or from any cause whatsoever, and without limiting the generality of the INSTITUTION (i) per occurrence an amount corresponding foregoing, whether caused by water leakage of any character from the roof, walls, or other portion of the Premises or the Building, the Project, or caused by gas, fire, oil, electricity, or any cause whatsoever, in, on, or about the Premises, the Building, the Project or any part thereof. Notwithstanding the foregoing, except as set forth in Paragraph 11 below and the last sentence of this Paragraph 10(b), Tenant shall not be required to waive claims against Landlord Parties where such injury or damage is due to the aggregated fees negligence or willful misconduct of Landlord, its employees, its property manager or its property manager’s employees (excluding pass through costs) paid or/including the negligence or willful misconduct of such parties as related to be paid construction or property management). Tenant acknowledges that any casualty insurance carried by the SPONSOR (and/or CRO) Landlord will not cover loss of income to Tenant or damage to the INSTITUTION for alterations in the Study under Premises installed by Tenant or Tenant’s personal property located within the Premises. Tenant shall be required to maintain the insurance described in Paragraph 10(d) during the Term. In the event of a discrepancy between the terms of this Agreement; paragraph and the terms of Paragraph 39 of the Lease concerning Hazardous Substance liability, the latter shall control (ii) in aggregate, an amount corresponding to [XX times] the aggregated fees paid/or to be paid by the SPONSOR (and/or CRO) except with respect to the INSTITUTION for last sentence of this Paragraph 10(b)). Nothing in this Paragraph 10(b) is intended to nor shall it be deemed to override 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] provisions of the end of the Study at the INSTITUTION in accordance with the ProtocolParagraph 11. Notwithstanding anything contained in this Lease 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 lawcontrary, in no event shall either Party be liable as between the Parties Landlord have any liability whatsoever to the other Tenant for any indirect consequential damages, or consequential damages loss of business, revenue or profits, even if caused by the active, passive, or gross negligence, or willful misconduct of any Landlord Party. (including lost profitsc) Except 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 or willful misconduct of that Party or Landlord, its agents or employees or to restrict or exclude any other liability of a Party which cannot be so restricted or excluded in law. 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 timesits property manager and its property manager’s employees, Tenant shall indemnify and hold Landlord harmless from and defend Landlord against any and all claims or liability for any injury or damage to have access to and inspect and verify any data records and reports in the INSTITUTION's and/or the INVESTIGATOR's possession, custody person 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 property whatsoever: (i) occurring in or on the INSTITUTION's fulfilment Premises; (ii) occurring in, on, or about any other portion of the Project to the extent such injury or damage shall be caused by the negligence or willful misconduct by Tenant, its obligations hereunder agents, servants, employees, or invitees (such ascollectively, including Tenant, “Tenant Parties”), or (iii) arising from any breach of this Lease by Tenant. Tenant further agrees to indemnify and hold Landlord harmless from, and defend Landlord against, any and all claims, losses, or liabilities (including damage to Landlord’s property) arising from (x) any breach of this Lease by Tenant and/or (y) the conduct of any work or business of Tenant Parties in or about the Project, including, but not limited to invoiced costs any release, discharge, storage or use of any hazardous substance, hazardous waste, toxic substance, oil, explosives, asbestos, or similar material. In the event of a discrepancy between the terms of this Paragraph and expensesthe terms of Paragraph 39 of the Lease concerning Hazardous Substance liability, the latter shall control. Nothing in this Paragraph 10(c) is intended to nor shall it be deemed to override the provisions of Paragraph 11. (d) Tenant shall procure at its cost and expense and keep in effect during the Term the following insurance: (1) commercial general liability insurance including contractual liability with a minimum combined single limit of liability of Three Million Dollars ($3,000,000). Such insurance shall name Landlord as an additional insured, and/or shall specifically include the liability assumed hereunder by Tenant, and is intended to be primary insurance, and not excess over or contributory with any other valid, existing, and applicable insurance in force for or on behalf of Landlord, and shall provide that Landlord shall receive thirty (30) days’ written notice from the insurer prior to any cancellation or change of coverage; (2) “all risk” property insurance (including, without limitation, boiler and machinery (if applicable); sprinkler damage, vandalism and malicious mischief) on any Alterations installed in the Premises by or on behalf of Tenant all leasehold improvements installed in the Premises by Tenant at its expense, and all of Tenant’s personal property, such insurance to include a building ordinance provision (as to those Alterations for which such a provision will apply). Such insurance shall be an amount equal to full replacement cost of the aggregate of the foregoing and shall provide coverage comparable to the coverage in the standard ISO All Risk form, when such form is supplemented with the coverages required above, and shall name Landlord as a loss payee; (3) worker’s compensation insurance; and (4) such other insurance as may be required by the law. All insurance policies required under this Paragraph 10(d) shall be issued by carriers each with a Best’s Insurance Reports policy holder’s rating of not less than A and a financial size category of not less than Class VIII. Tenant shall deliver policies of such insurance or certificates thereof to Landlord on or before the Commencement Date, and thereafter at any time and from time-to-time within ten (10) business days after written request from Landlord. In the event Tenant shall fail to procure and keep such insurance in full force and effect during the Term, or to deliver such policies or certificates within said time frame, Landlord may, at its option, procure same for the account of Tenant, and the cost thereof shall be paid to Landlord as Additional Rent within five(5) business days after delivery to Tenant of bills therefor. (e) The provisions of this Paragraph 10 shall survive the expiration or termination of this Lease with respect to any claims or liability occurring prior to such expiration or termination. (f) Landlord shall maintain insurance on the Project against fire and risks covered by “all risk” (excluding earthquake and flood, though Landlord, at its option, may include this coverage provided it can be obtained at commercially reasonable rates) on a 100% of “replacement cost” basis (though reasonable deductibles may be included under such coverage). Landlord’s insurance: (i) shall cover the Building; (ii) shall not cover any Alterations installed in the performance Premises by or on behalf of the Study by the INVESTIGATOR. The SPONSOR Tenant; (iii) shall inform the INSTITUTION within have a reasonable timeline compatible with the clinical activity of the INVESTIGATOR building ordinance provision; and INVESTIGATOR’s team. Upon request of SPONSOR, INSTITUTION and/or INVESTIGATOR (iv) shall provide to SPONSOR copies for rental interruption insurance covering a period of all materials, reports, correspondence, statements, forms and records which INSTITUTION and/or INVESTIGATOR receives, obtains or generates pursuant twelve (12) full months. In no event shall Landlord agree to any inspection co-insurance obligations under any such policies (beyond standard deductibles). Landlord shall also maintain commercial general liability insurance including, without limitation, contractual liability coverage (or with contractual liability endorsement) on an occurrence basis in connection amounts not less than Three Million Dollars ($3,000,000) per occurrence with respect to bodily injury or death and property damage. Notwithstanding the Studyforegoing obligations of Landlord to carry insurance, Landlord may modify the foregoing coverages if and to the extent it is commercially reasonable to do so. If Tenant disagrees that such coverage is commercially reasonable or in connection with any believes it is not necessary, then Tenant shall have the right to submit such 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 proceduresto arbitration.

Appears in 1 contract

Samples: Lease Agreement (Audience Inc)

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]Agreement. 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. 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.

Appears in 1 contract

Samples: Draft Agreement for Clinical Trials

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”a) from any and all duly evidenced liabilities, claims, actions, or suits Except to the extent caused by its negligence or wrongful acts or omissions; or the negligence or wrongful acts willful misconduct of Tenant Parties or omissions Tenant's breach 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 complaintLease, claim or injury relating to any loss subject to this indemnification. Neither Party Landlord shall indemnify and hold Tenant harmless from and defend Tenant against any and all claims or liability for any injury or damage to any person or property including any reasonable attorney's fees (but excluding any consequential damages or loss of business) occurring in, on, or about the Other Party’s Indemnitees from liabilities arising out of negligence Project to the extent such injury or wrongful acts or omissions of such Other Party’s Indemnitees. Without prejudice to SPONSOR’s no-fault liability towards Study Participants, damage is caused by 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 Landlord, its agents, contractors or employees (collectively, including Landlord, "Landlord Parties"). (b) Landlord shall not be liable to Tenant, and Tenant hereby waives all claims against Landlord Parties for any injury or damage to any person or property in or about the INVESTIGATOR and/or INSTITUTION, Premises by or from any cause whatsoever (other than the SPONSOR may seek recourse against the INVESTIGATOR and/or the INSTITUTION. Except in case of gross negligence or wilful misconductwillful misconduct of Landlord Parties), [including breach and without limiting the generality of Sponsor Owned Inventions under Article 6.4.3the foregoing, […][…] ]whether caused by water leakage of any character from the roof, walls, basement, or where such limitation would be prohibited other portion of the Premises or the Building, or caused by mandatory provisions of lawgas, fire, oil, electricity, or any cause whatsoever, in, on, or about the Premises, the INSTITUTION’s total liability and indemnification obligation under this Agreement Project or any part thereof (other than that caused by the gross negligence or willful misconduct of Landlord Parties). Tenant acknowledges that any casualty insurance carried by Landlord will not cover loss of income to Tenant or damage to the SPONSOR [Alterations in the Premises installed by Tenant or Tenant's personal property located within the Premises (except as provided in Paragraph 11(f) below). Tenant shall be required to maintain the insurance described in Paragraph 11(d) below during the Term. (c) Except to the extent caused by the gross negligence or willful misconduct of Landlord Parties, Tenant shall indemnify and CRO jointly] under hold Landlord harmless from and defend Landlord against any and all circumstances claims or liability 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 injury or damage to any person or property whatsoever: (i) per occurrence an amount corresponding to occurring in or on 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 AgreementPremises; and or (ii) in aggregateoccurring in, an amount corresponding to [XX times] the aggregated fees paid/on, or to be paid by the SPONSOR (and/or CRO) to the INSTITUTION for the Study under this Agreement [or such about any 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] portion 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) Project to the extent not covered under the civil liability insurance policy arising out of the subject matter such injury 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 damage is caused by the negligence or willful misconduct by the Tenant Parties. Except to the extent caused by the gross negligence or willful misconduct of that Party Landlord Parties, Tenant further agrees to indemnify and hold Landlord harmless from, and defend Landlord against, any and all claims, losses, or its agents or employees or liabilities (including damage to restrict or exclude Landlord's property) arising from (x) any other liability breach of a Party which cannot be so restricted or excluded this Lease by Tenant, (y) any matter referred to in law. Upon request by any authorised officer or employee Paragraph 11(g), and/or (z) the conduct of any relevant regulatory agencyactivities, work or other government authoritybusiness of Tenant Parties in or about the Project, 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 asincluding, but not limited to invoiced costs any release, discharge, storage or use of any Hazardous Substance. In the event of a discrepancy between the terms of this paragraph and expenses)the terms of Paragraph 41 of the Lease concerning Hazardous Substance liability, and/or the latter shall control. (d) Tenant shall procure at its cost and expense and keep in effect during the Term (and during the construction period for the Tenant Improvements) the following insurance: (i) Commercial general liability insurance on an occurrence form, including contractual liability, with a minimum combined single limit of liability of Three Million Dollars ($3,000,000) per occurrence. Such insurance shall name Landlord, any Mortgagee, any ground lessor, and such other parties as Landlord may request as additional insureds, shall specifically include the liability assumed hereunder by Tenant to the maximum extent it is possible to include such assumed liability at commercially reasonable rates, and shall provide that it is primary insurance, and not excess over or contributory with any other valid, existing and applicable insurance in force for or on behalf of Landlord, and shall provide that Landlord shall receive thirty (30) days' written notice from the insurer prior to any cancellation or change of coverage. The limits of such insurance shall not limit the liability of Tenant hereunder, and Tenant is responsible for ensuring that the amount of liability insurance carried by Tenant is sufficient for Tenant's purposes. (ii) Business interruption insurance, insuring Tenant for a period of twelve (12) months against losses arising from the performance interruption of Tenant's business, and for lost profits, and charges and expenses which continue but would have been earned if the Study by the INVESTIGATOR. The SPONSOR shall inform the INSTITUTION within a reasonable timeline compatible business had gone on without interruption, insuring against such perils, in such form and 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.such deductible amount as are commercially reasonable;

Appears in 1 contract

Samples: Lease Agreement (Business Objects Sa)

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”a) from any and all duly evidenced liabilities, claims, actions, or suits Except to the extent caused by its negligence or wrongful acts or omissions; or the negligence or wrongful acts willful misconduct of Tenant Parties or omissions Tenant's breach 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 complaintLease, claim or injury relating to any loss subject to this indemnification. Neither Party Landlord shall indemnify and hold Tenant harmless from and defend Tenant against any and all claims or liability for any injury or damage to any person or property including any reasonable attorney's fees (but excluding any consequential damages or loss of business) occurring in, on, or about the Other Party’s Indemnitees from liabilities arising out of negligence Project to the extent such injury or wrongful acts or omissions of such Other Party’s Indemnitees. Without prejudice to SPONSOR’s no-fault liability towards Study Participants, damage is caused by 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 Landlord, its agents, servants, contractors, employees (collectively, including Landlord, "Landlord Parties"). (b) Landlord shall not be liable to Tenant, and Tenant hereby waives all claims against Landlord Parties for any injury or damage to any person or property in or about the INVESTIGATOR and/or INSTITUTION, Premises by or from any cause whatsoever (other than the SPONSOR may seek recourse against the INVESTIGATOR and/or the INSTITUTION. Except in case of gross negligence or wilful misconductwillful misconduct of Landlord Parties), [including breach and without limiting the generality of Sponsor Owned Inventions under Article 6.4.3the foregoing, […][…] ]whether caused by water leakage of any character from the roof, walls, basement, or where such limitation would be prohibited other portion of the Premises or the Building, or caused by mandatory provisions of lawgas, fire, oil, electricity, or any cause whatsoever, in, on, or about the Premises, the INSTITUTION’s total liability and indemnification obligation under this Agreement Project or any part thereof (other than that caused by the gross negligence or willful misconduct of Landlord Parties). Tenant acknowledges that any casualty insurance carried by Landlord will not cover loss of income to Tenant or damage to the SPONSOR [Alterations in the Premises installed by Tenant or Tenant's personal property located within the Premises (except as provided in Paragraph 10(f) below). Tenant shall be required to maintain the insurance described in Paragraph 10(d) below during the Term. (c) Except to the extent caused by the gross negligence or willful misconduct of Landlord Parties, Tenant shall indemnify and CRO jointly] under hold Landlord harmless from and defend Landlord against any and all circumstances claims or liability 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 injury or damage to any person or property whatsoever: (i) per occurrence an amount corresponding to occurring in or on 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 AgreementPremises; and or (ii) in aggregateoccurring in, an amount corresponding to [XX times] the aggregated fees paid/on, or to be paid by the SPONSOR (and/or CRO) to the INSTITUTION for the Study under this Agreement [or such about any 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] portion 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) Project to the extent not covered under the civil liability insurance policy arising out of the subject matter such injury 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 damage 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 or willful misconduct by the Tenant Parties. Tenant further agrees to indemnify and hold Landlord harmless from, and defend Landlord against, any and all claims, losses, or liabilities (including damage to Landlord's property) arising from (x) any breach of that Party or its agents or employees or this Lease by Tenant, (y) any matter referred to restrict or exclude any other liability of a Party which cannot be so restricted or excluded in law. Upon request by any authorised officer or employee Paragraph 10(g), and/or (z) the conduct of any relevant regulatory agencywork or business of Tenant Parties in or about the Project, 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 asincluding, but not limited to invoiced costs any release, discharge, storage or use of any Hazardous Substance. In the event of a discrepancy between the terms of this paragraph and expensesthe terms of Paragraph 39 of the Lease concerning Hazardous Substance liability, the latter shall control. (d) Tenant shall procure at its cost and expense and keep in effect during the Term (and during the construction period for the Tenant Improvements) the following insurance: (i) Commercial general liability insurance on an occurrence form, including contractual liability, with a minimum combined single limit of liability of Three Million Dollars ($3,000,000). Such insurance shall name Landlord, and/or any Mortgagee, any ground lessor, and such other parties as Landlord may request as additional insureds, shall specifically include the liability assumed hereunder by Tenant, and shall provide that it is primary insurance, and not excess over or contributory with any other valid, existing and applicable insurance in force for or on behalf of Landlord, and shall provide that Landlord shall receive thirty (30) days' written notice from the insurer prior to any cancellation or change of coverage. The limits of such insurance shall not limit the liability of Tenant hereunder, and Tenant is responsible for ensuring that the amount of liability insurance carried by Tenant is sufficient for Tenant's purposes. (ii) Business interruption insurance, insuring Tenant for a period of twelve (12) months against losses arising from the performance interruption of Tenant's business, and for lost profits, and charges and expenses which continue but would have been earned if the Study by the INVESTIGATOR. The SPONSOR shall inform the INSTITUTION within a reasonable timeline compatible business had gone on without interruption, insuring against such perils, in such form and 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.such deductible amount as are commercially reasonable;

Appears in 1 contract

Samples: Lease Agreement (Broadcom Corp)

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. 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.

Appears in 1 contract

Samples: Preferred Provider Agreement (Pharmerica Inc)

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. 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.

Appears in 1 contract

Samples: Clinical Investigation Agreement

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. 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.

Appears in 1 contract

Samples: Mutual Aid Agreement

Insurance and Indemnification. In accordance with Applicable Laws18.1 Licensee agrees to hold harmless, defend and indemnify Equilink and its affiliates and each of their respective employees, directors and agents against any and all claims, suits, losses, expenses (including attorneys' fees), or damages directly or indirectly arising out of Licensee's promotion, advertising, manufacture, distribution or sale of the SPONSOR shall be liableLicensed Products and the use by third parties of such Licensed Products promoted, even without faultmanufactured, for advertised, distributed or sold by Licensee, or out of any damage incurred alleged unauthorized use of any patent, copyright, design, xxxx, process, idea, method, or device by a Study Participant or, Licensee in the case of death, his rightful claimants, that arises either in direct or indirect connection with the Study Licensed Products. 18.2 During the Term and shall provide compensation therefore. The SPONSOR shall enter into an insurance contract in accordance with Applicable Laws. Each Party, thereafter Equilink shall indemnify and hold harmless the otherLicensee, its affiliates and each of their respective officers, directors, agents and employees (collectively the “Other Party’s Indemnitees”) for, from and against any and all duly evidenced liabilities, claims, actionsdemands, or suits to the extent caused by its negligence or wrongful acts or omissions; or the negligence or wrongful acts or omissions causes 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 complaintaction, 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 policydamages, and (b) reasonable attorneys' fees 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 trademark infringement arising out of the subject matter or performance use of the Trademarks as strictly authorized under this Agreement. The INSTITUTION declares , provided that it has a mandatory civil liability insurance policy Equilink is given prompt notice of and shall have the option to undertake and conduct the defense of any such claim, demand or cause of action and further provided that Licensee shall cooperate in accordance with Applicable Laws which notably covers the INSTITUTION, defense of such claim as reasonably required by Equilink. 18.3 Licensee shall acquire and maintain at its employees including the INVESTIGATOR sole cost and undertakes to maintain such insurance policy expense throughout the term of this Agreement Commercial General Liability Insurance, including product liability and provides upon request contractual liability insurance (hereinafter referred to as "Commercial General Liability Insurance"), underwritten by an insurance company which has been rated at least A-VI by the most recent edition of Best's insurance report. The financial status of insurance companies located outside the United States must be acceptable to Equilink. This insurance coverage shall provide protection against any and all claims, demands, causes of action or damages, including attorney's fees, arising out of any alleged defects in the Licensed Products, or any use thereof of not less than three million dollars ($3,000,000) combined single limit for personal injury and property damage with MacMark and Equilink named as an additional insured party. In addition, Licensee shall name MacMark and Equilink as an insured on any excess or umbrella policies carried by Licensee. Licensee may, at its option, self insure all or any portion of the SPONSOR any updated above obligation. 18.4 Licensee shall furnish to Equilink certificates issued by the insurance certificate. The SPONSOR declares company setting forth the amount of Commercial General Liability Insurance, the policy number, the date of expiration, and warrants a provision that it has a civil liability insurance policy which notably covers the SPONSOR and its employees and undertakes Equilink shall receive thirty (30) days written notice prior to maintain such insurance policy throughout the term of this Agreement and provides upon request termination, reduction, or modification of the INSTITUTION coverage. Licensee's purchase of the Commercial General Liability Insurance or furnishing of the certificate of insurance shall not relieve Licensee of any updated insurance certificate. All Parties shall promptly inform each other of its obligations or liabilities under this Agreement. 18.5 Licensee agrees to provide Equilink with prompt notice of any claims claim, objection, suit or imminent claims relating dispute of any kind concerning the Trademarks and/or MacMark's and Equilink's rightful ownership of rights thereto. Equilink shall have at least ninety (90) days after receipt of said notice to exercise the option to undertake and conduct the defense of any suit so brought, and if Equilink does not undertake to conduct the Study. No admission defense of any such claim or settlements in respect suit, no settlement of the alleged liability of the other Party any such claim or suit shall be made without the Equilink's prior written approval of that Party (such consent not consent. Licensee agrees 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 reasonably cooperate fully with Equilink 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. 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 proceduresaction.

Appears in 1 contract

Samples: License Agreement (Riddell Sports Inc)

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. 5.1 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 Landlord shall be entitled to seek own counsel self-insure for workers’ compensation, commercial general liability, auto liability, or any claims against itself other coverage except Landlord shall obtain and keep in force all risk property insurance covering loss or its employees. Notwithstanding damage to all real and personal property except for that property which the provisions set out Tenant is obligated to insure under Section 5.2. 5.2 The Tenant shall maintain during this MOU insurance requirements pursuant to Exhibit “ ”. 5.3 Landlord and Tenant agree that all policies of insurance to be kept and maintained 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 force 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. Upon request by any authorised officer or employee of any relevant regulatory agencyrespective parties hereto, 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 Studyshall, unless prohibited by law or court order other regulation having the effect of law, contain provisions in which the rights of subrogation against the Landlord and Tenant are waived by the insurance company or carriers insuring the Premises, any building, or other property in line question. Landlord expressly waives any right of recovery against Tenant for damage to or loss of the building, the Premises, or the improvements thereon, which loss or damage may arise by fire or any other peril covered by any policy of insurance required to be maintained pursuant to this Lease which contains or is required to contain waiver of subrogation rights against Tenant pursuant to this Section, and Landlord shall make no claim for recovery against Tenant therefor, unless caused by the negligent act of the Tenant or its employees, agents, representatives and/or shareholders or members, negligence. Tenant expressly waives any right of recovery against Landlord for damage to or loss of its fixtures, improvements, or other property located in the Premises, which damage or loss may arise by fire or any other peril covered by any policy of insurance maintained or required to be maintained pursuant to this Lease which contains or is required to contain a waiver of subrogation right against Landlord as set forth in this Section, and Tenant shall make no claim for recovery against Landlord therefor, unless caused by the negligent act of the Landlord or its officials, employees, agents, representatives and/or shareholders or members, negligence. . (a) The Tenant shall indemnify, protect, defend and hold harmless the Landlord and its employees, from and against any and all claims, suits, actions, damages or causes of action of whatever nature arising out of the use or operation of the Premises or the surrounding areas, whether such claim shall be made by the Tenant, or an employee, agent, contractor, invitee or guest of the Tenant, an employee, agent or official of the Landlord or by any third party, and whether it relates to injury to persons (including death) or damage to property except where it is alleged that the Landlordor its employees or officials were negligent or that they acted intentionally. The Tenant shall, at its own cost and expense, pay and satisfy all costs related to any orders, judgments, or decrees which may be entered thereon, and all reasonable costs, attorneys’ fees, expenses and liabilities incurred in and about the defense of any such claims and the investigation thereof. The Tenant shall also indemnify, defend, protect and hold the Landlord harmless from and against any and all claims arising from any breach or default in performance of any obligation of the Tenant’s part to be performed under the terms of this Agreement, or arising from any act, neglect, fault or omission of the Tenant, its employees, agents, contractors, invitees, and guests, and from and against all reasonable costs, attorneys’ fees, expenses, and liability incurred in connection with INSTITUTIONany such claim or any action or proceeding brought thereon. The Tenant reserves the right to retain counsel of its choice. (b) The Tenant shall immediately notify the Landlord, in writing, of any claim or action filed, of whatever nature, arising out of the use or operation of the Premises by the Tenant, its employees, agents, contractors, invitees and guests. The Tenant shall also immediately notify the Landlord if the Tenant knows or has reason to believe a claim or action will be filed, of whatever nature, arising out of the use or operation of the Premises by the Tenant, its members, agents, contractors, employees, or servants. (c) Landlord shall indemnify, protect, defend and hold harmless the Tenant, its officers, directors, members, owners, shareholders and employees, from and against any and all claims, suits, actions, damages or causes of action of arising out or related to the negligent or intentional acts of the Landlord, its officials, agents, representative or employees, , whether such claim shall be made by the Landlord, or any official, employee, agent, contractor, invitee or guest of the Landlord, or by Tenant, its officers, directors, members, owners, shareholders and employees, or by any third party, and whether it relates to injury to persons (including death) or damage to property (d) The Landlord shall, at its own cost and expense, pay and satisfy all reasonable costs related to any orders, judgments or decrees which may be entered thereon, and all reasonable costs, attorneys’ fees, expenses and liabilities incurred in and about the defense of any such claims and the investigation thereof. The Landlord shall also indemnify, defend, protect and hold the Tenant, its officers, directors, members, owners, shareholders and employees harmless from and against any and all claims arising from any breach or default in performance of any obligation of the Landlord’s internal procedurespart to be performed under the terms of this Agreement, or arising from any act, neglect, fault or omission of the Landlord or its employees, agents, from and against all reasonable costs, attorneys’ fees, expenses and liability incurred in connection with any such claim or any action or proceeding brought thereon. (e) The Landlord reserves the right to defend itself. Tenant reserves the right to retain counsel of its choice. (f) The Landlord shall immediately notify the Tenant, in writing, of any claim or action filed, of whatever nature, arising out of the Property. The Landlord shall also immediately notify the Tenant if it knows or has reason to believe a claim or action will be filed, of whatever nature, arising from the Property. (g) The Parties acknowledge and accept that the Landlord’s responsibility under this section may be limited and will be limited to the extent applicable by Section 768.28, Florida Statutes for property loss, property damage, incident to injury to persons or property arising out of, or resulting from the negligent work or negligent act or omission relative to work performed by Landlord under this agreement, unless however, such claim, or demand shall arise out of, or result from the negligence, or misconduct of Tenant, its servants, agents, employees, or assigns, or to claims in the nature of contract, equity, or violation (s) of an applicable law.

Appears in 1 contract

Samples: Lease 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 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. 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.

Appears in 1 contract

Samples: Master Agreement for Commercial Clinical Research

Insurance and Indemnification. In accordance with Applicable Laws, 10.1. Tenant shall carry (at its sole expense and during the SPONSOR shall be liable, even without fault, for any damage incurred by a Study Participant or, Lease Term) fire and extended coverage insurance insuring Tenant’s interest in its improvements to the case of death, his rightful claimants, that arises either in direct or indirect connection with the Study Premises 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 liabilitiesfurniture, claimsequipment, actionssupplies, and other property owned, leased, held or suits possessed by it and contained therein, such insurance coverage to be in an amount equal to the extent caused full insurable value of such improvements and property, as such may increase from time to time, and workmen’s compensation insurance shall include Landlord as a loss payee as its interests may appear. Tenant shall also procure and maintain throughout the Lease Term a policy or policies of insurance, insuring Tenant, Landlord and any other person designated by its negligence Landlord, against any and all liability for injury to or wrongful acts death of a person or omissions; persons and for damage to property occasioned by 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, any construction work being done on 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, […][…] ]Premises, 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 condition, use, or performance occupancy of this Agreement. The INSTITUTION declares that it has a mandatory civil liability insurance policy the Premises, or in accordance with Applicable Laws which notably covers any way occasioned by or arising out of the INSTITUTIONactivities of Tenant, its employees including agents, employees, guests, or licensees in the INVESTIGATOR and undertakes to maintain such insurance policy throughout the term of this Agreement and provides upon request Premises, or other portions of the SPONSOR any updated Building, or the Property, which policy or policies shall include contractual liability coverage insuring Tenant’s indemnity obligations under this Lease. Tenant shall have included in all policies of insurance certificate. The SPONSOR declares and warrants that obtained by 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 with respect to the conduct Premises a waiver by the insurer of all right of subrogation against Landlord in connection with any loss or damage thereby insured against. To the Study. No admission full extent permitted by law, Tenant waives all right of recovery against Landlord for, and agrees to release Landlord from liability for, loss or settlements in respect damage to the Building, Premises or other tangible property, or any resulting loss of the alleged liability of the other Party shall be made without the prior written approval of that Party (income unless 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 loss 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 damage results from the negligence of that Party or Landlord, its agents or employees or to restrict or exclude any other liability of a Party which cannot be so restricted or excluded in law. Upon request by any authorised officer or employee of any relevant regulatory agencyagents, or other government authority, the INSTITUTION and the INVESTIGATOR are entitled and obliged to permit such officers contractors or employees. All said insurance policies shall be carried with companies licensed to do business in the State of Florida, at reasonable times, to have access to and inspect and verify any data records and reports least “A-” rated in the INSTITUTION's and/or the INVESTIGATOR's possessionmost recent edition of Best’s Insurance Reports, custody or control relating shall be otherwise reasonably satisfactory to Landlord, and shall be non-cancelable except after thirty (30) days written notice to Landlord. Duly executed certificates of insurance with respect thereto shall be delivered to Landlord prior to the Study date that Tenant takes possession of the Premises and renewals thereof as required shall be delivered to Landlord at least thirty (30) days prior to the expiration of each respective policy term. All policies carried by Tenant shall be written as primary policies, not contributing with and not in excess of the coverage which Landlord may carry, and shall submit only be subject to such data records deductibles as may be approved by Landlord in advance in writing. Landlord agrees to carry replacement cost insurance on the Building which as is customary and reasonable. 10.2. Tenant hereby agrees to indemnify and hold Landlord harmless from any injury, expense, damage, liability or reports to the said regulatory agency upon its request. In the case of a GCP inspectionclaim, 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 asincluding, but not limited to, attorney’s fees, imposed on Landlord by any person or other party, whether due to invoiced damage to the Premises, claims for injuries to the person or property of any other tenant of the Building or the Property or of any other person in or about the Building or the Property for any purpose whatsoever; or administrative or criminal action by a governmental authority, where such injury, expense, damage, liability or claim results either directly or indirectly from the occupancy or use by Tenant of the Property or the conduct of Tenant’s business thereon, the construction by Tenant or by any agent or contractor of Tenant of any Tenant Improvements or other improvements in the Premises or in the Building, the act, omission, negligence, or misconduct of Tenant, or any agents, contractors, servants, or employees of Tenant, or any other person entering upon the Premises under express or implied invitation or consent of Tenant, the failure to fully perform any provision of this Lease by Tenant, or any litigation commenced by or against Tenant to which Landlord is made a party without fault on the part of Landlord. Tenant further agrees to reimburse Landlord for any costs or expenses, including, but not limited to, court costs and expenses)reasonable attorney's fees, and/or (ii) which Landlord may incur in investigating, handling or litigating any such claim or any action by a governmental authority. 10.3. Landlord hereby agrees to indemnify and hold Tenant harmless from any injury, expense, damage, liability or claim, including, but not limited to, attorney’s fees, imposed on Tenant by any person or other party, whether due to damage to the performance Premises, claims for injuries to the person or property of any other tenant of the Study Building or the Property or of any other person in or about the Building or the Property for any purpose whatsoever; or administrative or criminal action by a governmental authority, where such injury, expense, damage, liability or claim results either directly or indirectly from the INVESTIGATOR. The SPONSOR shall inform the INSTITUTION within a reasonable timeline compatible with the clinical activity occupancy or use by Landlord of the INVESTIGATOR and INVESTIGATORProperty or the conduct of Landlord’s team. Upon request business thereon including the acts of SPONSORany other Tenant resulting from Landlord’s negligence or willful intentional conduct, INSTITUTION and/or INVESTIGATOR shall provide to SPONSOR copies the construction by Landlord or by any agent or contractor of all materialsLandlord of any Landlord Improvements or other improvements in the Premises or in the Building, reportsthe act, correspondenceomission, statements, forms and records which INSTITUTION and/or INVESTIGATOR receives, obtains or generates pursuant to any inspection in connection with the Studynegligence, or misconduct of Landlord, or any agents, contractors, servants, or employees of Landlord, the failure to fully perform any provision of this Lease by Landlord, or any litigation commenced by or against Landlord to which Tenant is made a party without fault on the part of Tenant. Landlord further agrees to reimburse Tenant for any costs or expenses, including, but not limited to, court costs and reasonable attorney's fees, which Tenant may incur in connection with investigating, handling or litigating any matter that may affect INSTITUTION’s OR INVESTIGATOR’s performance of the Study, unless prohibited such claim or any action by law or court order and in line with INSTITUTION’s internal proceduresa governmental authority.

Appears in 1 contract

Samples: Lease Agreement (Rock Creek Pharmaceuticals, Inc.)

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. 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.

Appears in 1 contract

Samples: Clinical Trial Agreement

Insurance and Indemnification. In accordance a. Tenant (including also anyone holding under Tenant and any and all subtenants and other occupants of the Premises) hereby releases Landlord from any and all liability for any and all bodily and personal injury to Tenant and its contractor(s) (including also all subcontractor(s)) and their respective employees (whether direct or indirect employees) and for any and all loss of or damage to Tenant’s property and that of any and all contractors and subcontractors (including also any and all loss of use resulting therefrom) and, on behalf of its insurers, hereby waives any and all rights of subrogation therefore, even though such injury, loss or damage may have resulted in whole or in part from the act or neglect of Landlord. Tenant shall cause CresaPartners and all subcontractor(s) to provide identical waivers of liability and subrogation in favor of Landlord. b. All insurance to be provided by Tenant, CresaPartners and all subcontractor(s) hereunder shall be issued by such insurance companies as Landlord shall approve. As often as any such policy shall expire or otherwise terminate, renewal or additional policies shall be procured and maintained by Tenant and Tenant's contractor(s) and subcontractor(s) to provide uninterrupted coverage. Tenant agrees and shall cause its contractor(s) and subcontractor(s) to agree to provide Landlord, upon Landlord's request from time to time, with Applicable Lawscertified copies of all policies of insurance providing coverage in this Agreement. c. Tenant shall indemnify, defend and hold Landlord harmless against any loss, liability, injury or damage to persons or property resulting from Tenant’s Improvements including the activities of Tenant's contractor(s) and subcontractor(s). d. All policies (except the worker's compensation policy) shall be endorsed to include as additional insured parties the parties listed on, or required by, the SPONSOR Lease, Landlord's contractors, Landlord's architects, and their respective beneficiaries, partners, directors, officers, members, employees and agents, and such additional persons as Landlord may designate. The waiver of subrogation provisions contained in the Lease shall apply to all insurance policies (except the workmen's compensation policy) to be obtained by Tenant pursuant to this paragraph. The insurance policy endorsements shall also provide that all additional insured parties shall be liablegiven thirty (30) days' prior written notice of any reduction, even without fault, for any damage incurred by a Study Participant or, cancellation or non-renewal of coverage (except that ten (10) days' notice shall be sufficient in the case of death, his rightful claimants, that arises either in direct or indirect connection with the Study cancellation for non-payment of premium) and shall provide compensation thereforethat the insurance coverage afforded to the additional insured parties thereunder shall be primary to any insurance carried independently by said additional insured parties. The SPONSOR Additionally, where applicable, each policy shall enter into an insurance contract contain a cross-liability and severability of interest clause. e. Without limitation of the indemnification provisions contained in accordance with Applicable Laws. Each Partythe Lease, shall indemnify to the fullest extent permitted by law Tenant agrees to indemnify, protect, defend and hold harmless Landlord, the otherparties listed, its agents or required by, the Lease to be named as additional insureds, Landlord’s contractors, Landlord's architects, and their respective beneficiaries, partners, directors, officers, members, managers, employees (collectively the “Other Party’s Indemnitees”) and agents, from any and against all duly evidenced claims, liabilities, claimslosses, actions, or suits to the extent caused by its negligence or wrongful acts or omissions; or the negligence or wrongful acts or omissions damages and expenses 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 whatever nature 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. 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 Tenant’s Improvements or the entry of Tenant or Tenant's Contractors into the Building and the Premises, including, without limitation, mechanic's liens, the cost of any matter repairs to the Premises or Building necessitated by activities of Tenant or Tenant’s Contractors, bodily injury to persons or damage to the property of Tenant, its employees, agents, invitees, licensees or others. It is understood and agreed that may affect INSTITUTION’s OR INVESTIGATOR’s performance the foregoing indemnity shall be in addition to the insurance requirements set forth above and shall not be in discharge of or in substitution for same or any other indemnity or insurance provision of the Study, unless prohibited by law or court order and in line with INSTITUTION’s internal proceduresLease.

Appears in 1 contract

Samples: Premises Lease (Zynex Inc)

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”a) from any and all duly evidenced liabilities, claims, actions, or suits Except 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 willful misconduct of any such complaintTenant Parties, claim or injury relating to any loss subject to this indemnification. Neither Party Landlord shall indemnify and hold Tenant harmless from and against any and all claims or liability for any injury or damage to any person or property including any reasonable attorney’s fees (but excluding any consequential damages or loss of business) occurring in, on, or about the Other Party’s Indemnitees from liabilities arising out of negligence Project to the extent such injury or wrongful acts or omissions of such Other Party’s Indemnitees. Without prejudice to SPONSOR’s no-fault liability towards Study Participants, damage is caused by 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 INSTITUTIONLandlord, 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 its (a) for damages covered under is intended to nor shall it be deemed to override the civil liability insurance policy provisions of the INSTITUTION in accordance with Article 7.6, the effective coverage under such insurance policy, and Paragraph 11. (b) Landlord shall not be liable to Tenant, and Tenant hereby waives all claims against Landlord Parties for damages not covered under any injury or damage to any person or property in or about the civil liability insurance policy Premises by or from any cause whatsoever, and without limiting the generality of the INSTITUTION (i) per occurrence an amount corresponding foregoing, whether caused by water leakage of any character from the roof, walls, or other portion of the Premises or the Building, the Project, or caused by gas, fire, oil, electricity, or any cause whatsoever, in, on, or about the Premises, the Building, the Project or any part thereof. Notwithstanding the foregoing, except as set forth in Paragraph 11 below and the last sentence of this Paragraph 10(b), Tenant shall not be required to waive claims against Landlord Parties where such injury or damage is due to the aggregated fees negligence or willful misconduct of Landlord, its employees, its property manager or its property manager’s employees (excluding pass through costs) paid or/including the negligence or willful misconduct of such parties as related to be paid construction or property management). Tenant acknowledges that any casualty insurance carried by the SPONSOR (and/or CRO) Landlord will not cover loss of income to Tenant or damage to the INSTITUTION for alterations in the Study under Premises installed by Tenant or Tenant’s personal property located within the Premises. Tenant shall be required to maintain the insurance described in Paragraph 10(d) during the Term. In the event of a discrepancy between the terms of this Agreement; paragraph and the terms of Paragraph 39 of the Lease concerning Hazardous Substance liability, the latter shall control (ii) in aggregate, an amount corresponding to [XX times] the aggregated fees paid/or to be paid by the SPONSOR (and/or CRO) except with respect to the INSTITUTION for last sentence of this Paragraph 10(b)). Nothing in this Paragraph 10(b) is intended to nor shall it be deemed to override 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] provisions of the end of the Study at the INSTITUTION in accordance with the ProtocolParagraph 11. Notwithstanding anything contained in this Lease 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 lawcontrary, in no event shall either Party be liable as between the Parties Landlord have any liability whatsoever to the other Tenant for any indirect consequential damages, or consequential damages loss of business, revenue or profits, even if caused by the active, passive, or gross negligence, or willful misconduct of any Landlord Party. (including lost profitsc) Except 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 or willful misconduct of that Party or Landlord, its agents or employees or to restrict or exclude any other liability of a Party which cannot be so restricted or excluded in law. 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 timesits property manager and its property manager’s employees, Tenant shall indemnify and hold Landlord harmless from and defend Landlord against any and all claims or liability for any injury or damage to have access to and inspect and verify any data records and reports in the INSTITUTION's and/or the INVESTIGATOR's possession, custody person 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 property whatsoever: (i) occurring in or on the INSTITUTION's fulfilment Premises; (ii) occurring in, on, or about any other portion of the Project to the extent such injury or damage shall be caused by the negligence or willful misconduct by Tenant, its obligations hereunder agents, servants, employees, or invitees (such ascollectively, including Tenant, “Tenant Parties”), or (iii) arising from any breach of this Lease by Tenant. Tenant further agrees to indemnify and hold Landlord harmless from, and defend Landlord against, any and all claims, losses, or liabilities (including damage to Landlord’s property) arising from (x) any breach of this Lease by Tenant and/or (y) the conduct of any work or business of Tenant Parties in or about the Project, including, but not limited to invoiced costs any release, discharge, storage or use of any hazardous substance, hazardous waste, toxic substance, oil, explosives, asbestos, or similar material. In the event of a discrepancy between the terms of this Paragraph and expensesthe terms of Paragraph 39 of the Lease concerning Hazardous Substance liability, the latter shall control. Nothing in this Paragraph 10(c) is intended to nor shall it be deemed to override the provisions of Paragraph 11. (d) Tenant shall procure at its cost and expense and keep in effect during the Term the following insurance: (1) commercial general liability insurance including contractual liability with a minimum combined single limit of liability of Three Million Dollars ($3,000,000). Such insurance shall name Landlord as an additional insured, and/or shall specifically include the liability assumed hereunder by Tenant, and is intended to be primary insurance, and not excess over or contributory with any other valid, existing, and applicable insurance in force for or on behalf of Landlord, and shall provide that Landlord shall receive thirty (30) days’ written notice from the insurer prior to any cancellation or change of coverage; (2) “all risk” property insurance (including, without limitation, boiler and machinery (if applicable); sprinkler damage, vandalism and malicious mischief) on any Alterations installed in the Premises by or on behalf of Tenant all leasehold improvements installed in the Premises by Tenant at its expense, and all of Tenant’s personal property, such insurance to include a building ordinance provision (as to those Alterations for which such a provision will apply). Such insurance shall be an amount equal to full replacement cost of the aggregate of the foregoing and shall provide coverage comparable to the coverage in the standard ISO All Risk form, when such form is supplemented with the coverages required above, and shall name Landlord as a loss payee; (3) worker’s compensation insurance; and (4) such other insurance as may be required by the law. All insurance policies required under this Paragraph 10(d) shall be issued by carriers each with a Best’s Insurance Reports policy holder’s rating of not less than A and a financial size category of not less than Class VIII, Tenant shall deliver policies of such insurance or certificates thereof to Landlord on or before the Commencement Date, and thereafter at any time and from time-to-time within ten (10) business days after written request from Landlord. In the event Tenant shall fail to procure and keep such insurance in full force and effect during the Term, or to deliver such policies or certificates within said time frame, Landlord may, at its option, procure same for the account of Tenant, and the cost thereof shall be paid to Landlord as Additional Rent within five (5) business days after delivery to Tenant of bills therefor. (e) The provisions of this Paragraph 10 shall survive the expiration or termination of this Lease with respect to any claims or liability occurring prior to such expiration or termination. (f) Landlord shall maintain insurance on the Project against fire and risks covered by “all risk” (excluding earthquake and flood, though Landlord, at its option, may include this coverage provided it can be obtained at commercially reasonable rates) on a 100% of “replacement cost” basis (though reasonable deductibles may be included under such coverage). Landlord’s insurance: (i) shall cover the Building; (ii) shall not cover any Alterations installed in the performance Premises by or on behalf of the Study by the INVESTIGATOR. The SPONSOR Tenant; (iii) shall inform the INSTITUTION within have a reasonable timeline compatible with the clinical activity of the INVESTIGATOR building ordinance provision; and INVESTIGATOR’s team. Upon request of SPONSOR, INSTITUTION and/or INVESTIGATOR (iv) shall provide to SPONSOR copies for rental interruption insurance covering a period of all materials, reports, correspondence, statements, forms and records which INSTITUTION and/or INVESTIGATOR receives, obtains or generates pursuant twelve (12) full months. In no event shall Landlord agree to any inspection co-insurance obligations under any such policies (beyond standard deductibles). Landlord shall also maintain commercial general liability insurance including, without limitation, contractual liability coverage (or with contractual liability endorsement) on an occurrence basis in connection amounts not less than Three Million Dollars ($3,000,000) per occurrence with respect to bodily injury or death and property damage. Notwithstanding the Studyforegoing obligations of Landlord to carry insurance, Landlord may modify the foregoing coverages if and to the extent it is commercially reasonable to do so. If Tenant disagrees that such coverage is commercially reasonable or in connection with any believes it is not necessary, then Tenant shall have the right to submit such 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 proceduresto arbitration.

Appears in 1 contract

Samples: Lease Agreement (Audience Inc)

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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. 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.

Appears in 1 contract

Samples: Clinical Trial Site Agreement

Insurance and Indemnification. In accordance [ At all times during the term of this Agreement,] Consignee shall, at Consignee’s expense, maintain adequate public liability[ and], property damage [insurance with Applicable Lawsrespect to Consignee’s truck, the SPONSOR operation thereof and the operation of the Distributorship, with an]and, where appropriate, workers’ compensation insurance [company acceptable to Bakery, protecting]to protect Bakery and Consignee against any and all claims of personal injury, death or property damage, other than damage to Consigned Products in possession of Consignee. [Said]Such insurance shall be[ written with limits] in such amounts [as Bakery may reasonably request. Any such insurance policy]and have such limits as shall be liable, even without fault, for any damage incurred acceptable to Bakery or required by a Study Participant or, the retail stores in the case of deathterritory, his rightful claimantswhichever is greater, that arises either in direct or indirect connection with the Study shall name Bakery as an additional insured thereunder and shall provide that the insurance may not be terminated without at least fifteen (15) days[ advance]’ prior written notice [of cancellation be given ]to Bakery. [A certificate indicating such insurance coverage]Consignee shall[ be delivered to Bakery], prior to the date of execution [and delivery ]of this Agreement, and at [. such times as may be requested by Bakery. Xxxxxxxxx shall also obtain for his/her own benefit and for the benefit of his/her helpers, if any, worker’s compensation thereforeinsurance. The SPONSOR A certificate indicating]least annually thereafter, provide Bakery with insurance certificates evidencing such[ insurance] coverage[ shall enter into an insurance contract in accordance with Applicable Lawsalso be delivered to Bakery]. Each PartyConsignee [convenants]covenants and agrees to indemnify, shall indemnify defend and hold harmless the other, its agents save Bakery harmless[ of and] from and employees (collectively the “Other Party’s Indemnitees”) from against any and all duly evidenced liabilitiesclaims relating to payroll, claimsunemployment compensation, actionsemployee benefits, personal injury, death, or suits property damage (other than damage 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 Consigned Products in the Study with any adverse reaction in direct possession of Consignee) caused or indirect connection with the Study. In case of gross negligence alleged to have been caused directly or willful misconduct indirectly by or [through]as a result of the INVESTIGATOR and/or INSTITUTIONactions of Consignee or his/her/its helper or helpers, if any, or by or [through]as a result of the SPONSOR may seek recourse against operation of the INVESTIGATOR and/or the INSTITUTION. Except in case of gross negligence Distributorship or wilful misconductany vehicle or equipment owned or used by Consignee or his/her/its helper or helpers, if any, [or otherwise]and any and all losses, damages, liabilities and expenses (including breach of Sponsor Owned Inventions under Article 6.4.3, […][…] ], or where such limitation would be prohibited attorney’s fees) incurred by mandatory provisions of law, the INSTITUTION’s total liability and indemnification obligation under Bakery as a result thereof. Anything in this Agreement to the SPONSOR [and CRO jointly] under contrary notwithstanding, this indemnification provision shall survive 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 termination 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. 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.

Appears in 1 contract

Samples: Distributorship Agreement

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. 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.

Appears in 1 contract

Samples: Credit Agreement (MPW Industrial Services Group Inc)

Insurance and Indemnification. In accordance with Applicable Laws(i) After the Effective Time, the SPONSOR Buyer (collectively, the "Indemnifying Party") shall be liableindemnify, even without faultdefend and hold harmless, to the full extent a corporation is permitted under the Nevada Law to indemnify the Target's directors, officers and agents (collectively the "Indemnified Party"), each person who is now, or has been at any time prior to the date of this Agreement or who becomes prior to the Effective Time an officer or director of Target, and for purposes of clause (ii) below any damage incurred by a Study Participant or, agent of Target acting at the request of its officers or directors in the case of death, his rightful claimants, that arises either in direct or indirect connection with the Study negotiation, execution 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 delivery of this Agreement and provides upon request the consummation of the SPONSOR any updated insurance certificate. The SPONSOR declares and warrants Merger (the "Indemnified Parties") against (i) all losses, claims, damages, costs, reasonable expenses, liabilities or judgments or amounts ("Indemnified Liabilities") that it has a civil liability insurance policy which notably covers are paid in settlement with the SPONSOR and its employees and undertakes to maintain such insurance policy throughout the term of this Agreement and provides upon request approval 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 Indemnifying Party (such consent which approval shall 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. 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 claim, action, suit, proceeding or investigation based in whole or in part on or arising in whole or in part out of the Studyfact that such person is or was a director or officer of Target, unless prohibited whether pertaining to any matter existing now or occurring at or prior to the Effective Time and whether asserted or claimed prior to or at or after the Effective Time. The Indemnifiying Party will pay expenses incurred by law an Indemnified Party in advance of the final disposition of any such action or court order proceeding upon receipt of an undertaking by or on behalf of such Indemnified Party to repay such amount if it shall ultimately be determined that he is not entitled to be indemnified. (ii) For the entire period from the Effective Time until at least three years after the Effective Time, the Buyer will cause the Target to maintain without any reduction in scope or coverage the indemnification provisions for present and former officers and directors contained in line with INSTITUTION’s internal proceduresBuyer's Certificate of Incorporation and By-laws in effect on the date hereof. (iii) The provisions of this paragraph 5(h) shall survive the Effective Time and are intended to be for the benefit of and shall be enforceable by each Indemnified Party and his or her heirs and representatives.

Appears in 1 contract

Samples: Merger Agreement (Nucleus Inc)

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 time allowed by law. Consultant Services Agreement (Rev. 1/23/18) 9.2 Consultant shall maintain insurance conforming to the SPONSOR any updated insurance certificate. The SPONSOR declares and warrants that it has following specifications to the fullest amount allowed by law for a civil liability insurance policy which notably covers minimum of years following the SPONSOR and its employees and undertakes to maintain such insurance policy throughout the term termination or completion 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. 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.Agreement:

Appears in 1 contract

Samples: Consultant Services Agreement

Insurance and Indemnification. In accordance with Applicable Laws(a) Tenant agrees to defend, the SPONSOR shall be liableindemnify, even without faultand hold Landlord safe and harmless from all claims for personal injury, for any damage incurred by a Study Participant or, in the case of death, his rightful claimantsor property damage by any one or any cause on, that arises either in direct in, upon or indirect connection with about 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 Premises not 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 Landlord, its agents, contractors or employees, including all costs, reasonable attorneys' fees and other expenses incurred in the INVESTIGATOR and/or INSTITUTIONdefense of any such claim, and to provide and keep in force throughout the SPONSOR Term, in a reputable company or companies licensed to do business in the State of Maryland and in form satisfactory to Landlord, public liability insurance coverage with limits of not less than One Million Dollars ($1,000,000.000) per injury, per occurrence, and Three Million Dollars ($3,000,000.00) per occurrence in the aggregate, and Two Hundred and Fifty Thousand Dollars ($250,000.00) for damage to property. Tenant's insurance policy or policies shall name Landlord and Tenant as insureds as their interests may seek recourse appear and over them from and against claims for personal injuries, death or property damage occurring in, upon or about the INVESTIGATOR and/or Premises. (b) Tenant agrees to obtain and keep in force throughout the INSTITUTIONTerm, at its own expense, in a reputable company or companies licensed to do business in the State of Maryland, an insurance policy or policies providing protection against any peril included within the classification of "Fire and Extended Coverage," covering its leasehold estate in the Premises and all trade fixtures, merchandise and other property in, on or about the Premises, and all improvements and alterations made by or on behalf of Tenant, for their full insurable value or replacement cost. Except Such policy or policies of insurance shall be in case form reasonably satisfactory to Landlord, shall name Landlord as an additional insured and shall contain a provision by which the insurer waives any right or subrogation against Landlord arising out of any loss covered by such insurance. Landlord shall not be liable to Tenant for any loss or damage to such improvements or Tenant's property or estate caused by fire or any other risk that is (i) covered by such insurance or (ii) included in the coverage of the standard fire and extended coverage insurance available in Maryland for insuring such improvements, property and estate at the time of such loss or damage. Further, Landlord shall not be liable to Tenant for any damage to Tenant's property or estate caused by the negligence or intentional acts of any other tenants in the Building or caused by any reason whatsoever, except if caused by the gross negligence or wilful misconductmisconduct of Landlord, [including breach of Sponsor Owned Inventions under Article 6.4.3its agents, […][…] ], contractors or where such limitation would be prohibited by mandatory provisions of law, employees. It is 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 intent of the INSTITUTION in accordance with Article 7.6, the effective coverage under such insurance policyforegoing, and (b) for damages not covered under the civil liability insurance policy of the INSTITUTION (i) per occurrence an amount corresponding Landlord and Tenant covenant and agree, that Tenant shall protect itself against injury, loss or damage 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; its property and (ii) in aggregateestate arising from any cause whatsoever, 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 than 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 solely by the negligence of that Party Landlord or its agents agents, through procurement of available insurance coverage, without subjecting Landlord to liability to Tenant for any injury, loss or employees or damage, and further, without subjecting Landlord to restrict or exclude any other liability of a Party which cannot be so restricted or excluded in law. Upon request by any authorised officer or employee subrogation claims of any relevant regulatory agencyinsurer. (c) Tenant shall not do or permit to be done, nor keep or permit to be kept, anything in, upon or about the Premises which will contravene the policies of insurance against loss or damage by fire or other government authorityhazards, 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 asincluding, but not limited to, public liability, or which will prevent procuring such policies in companies acceptable to invoiced costs Landlord. If anything done, omitted to be done, or permitted to be done by Tenant, or kept, or permitted by Tenant to be kept, in, upon or about the Premises shall cause the rate of fire or other insurance on the Premises, the Building or on other property of Landlord in the Building, in companies acceptable to Landlord, to be increased beyond the minimum rate from time to time applicable to the Premises or the Building, Tenant shall pay the amount of such increase promptly upon Landlord's demand. (d) All insurance policies to be maintained by Tenant under this Paragraph 12 shall provide that they may not be cancelled or materially modified without thirty (30) days' prior written notice to Landlord and expenses), and/or (ii) the performance any known mortgage of the Study Premises or the Building, provided Tenant has been provided with the name and address of Landlord's mortgagee. (e) Tenant shall, prior to the entry by Tenant on the Premises, and annually thereafter, without request by Landlord, furnish Landlord with a certificate on XXXXX Form 27 showing that its required insurance is in full force and effect, and a copy of all such insurance policies. (f) Landlord covenants to carry insurance for replacement costs. (g) All insurance policies with respect to the Building and the Premises shall include a waiver 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 insurer of all materialsright of subrogation against Landlord or Tenant, reportstheir officers, correspondencedirectors, statementsemployees, forms agents and records which INSTITUTION and/or INVESTIGATOR receives, obtains or generates pursuant to any inspection in connection with the Study, or invitees in connection with any matter that may affect INSTITUTION’s OR INVESTIGATOR’s performance loss or damage thereby insured against, to the extent of the Study, unless prohibited by law or court order and in line with INSTITUTION’s internal procedures.such

Appears in 1 contract

Samples: Lease Agreement (Nfo Worldwide Inc)

Insurance and Indemnification. In accordance with Applicable Laws, the SPONSOR (a) Landlord shall not be liable, even without fault, liable to Tenant except for Landlord's own gross negligence. Tenant hereby waives all claims against Landlord for any injury or damage incurred to any person or property in or about the Premises by a Study Participant oror from any cause whatsoever, in including without limitation, damage caused by water leakage of any character from the case roof, walls, pipes, basement or other portion of deaththe Premises or the Building, his rightful claimantsor caused by gas, that arises either in direct fire, oil, electricity or indirect connection with any cause whatsoever, in, on or about the Study and Premises or the Building or any part thereof. (b) Tenant shall provide compensation therefore. The SPONSOR shall enter into an insurance contract in accordance with Applicable Laws. Each Partyindemnify, shall indemnify defend and hold Landlord harmless the other, its agents and employees (collectively the “Other Party’s Indemnitees”) from any and all duly evidenced liabilitiesclaims or liability for any injury or damage to any person or property whatsoever, claims, actions, or suits unless and to the extent that such claims or liability are due to Landlord's own gross negligence, which claims shall occur on or about the Premises (including the Building Common Areas), or on or about the Office Park (including common areas thereof), when such injury or damage shall be caused in whole or in part by the act, failure to act, neglect or fault of Tenant, its negligence agents, servants, employees 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 Agreementinvitees. Each Party Tenant 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 further indemnify and hold Landlord 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 any default by Tenant in the Study performance of any covenant to be performed by Tenant pursuant to this Lease or which shall arise from any act or negligence of Tenant, or any of its agents, contractors, servants, employees or licensees, and from and against all costs, counsel fees, and expenses which Landlord shall incur in connection with any adverse reaction in direct such claim or indirect connection with the Studyaction or proceeding brought thereon. In case of gross negligence or willful misconduct of the INVESTIGATOR and/or INSTITUTIONFurthermore, the SPONSOR may seek recourse against the INVESTIGATOR and/or the INSTITUTION. Except in case of gross negligence any action or wilful misconduct, [including breach of Sponsor Owned Inventions under Article 6.4.3, […][…] ], or where such limitation would proceeding shall be prohibited brought against Landlord 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 reason of any claims or imminent liabilities not due to Landlord's own gross negligence, Tenant shall defend such action or proceeding at Tenant's sole expense by counsel chosen by Landlord and reasonably satisfactory to Tenant. The provisions of this Paragraph 10 shall survive the expiration or termination of this Lease with respect to any claims relating or liability occurring prior to such expiration or termination. (c) Tenant shall procure at its cost and expense, and shall keep in effect during the conduct term of the Study. No admission or settlements in respect Lease, comprehensive general liability insurance including contractual liability with a minimum combined single limit of the alleged liability of the other Party shall be made without greater of the prior written approval of that Party amount required in the Basic Lease Information, or One Million Dollars (such consent not to be unreasonably withheld$1,000,000.00). For The insurance required by this Paragraph 10(c) shall name Landlord as an additional insured, shall specifically include the avoidance liability assumed hereunder by Tenant (provided that the amount of doubt, each Party such insurance shall not be entitled construed 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 limit the liability of any Party vis-à-vis the Study Participants in relation to their death Tenant hereunder), and shall provide that it is primary insurance, and not excess over or personal injury caused by the negligence of that Party or its agents or employees or to restrict or exclude contributory with any other liability valid, existing and applicable insurance in force for or on behalf of a Party which cannot be so restricted or excluded in law. Upon request by any authorised officer or employee of any relevant regulatory agencyLandlord, 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 provide that Landlord shall receive thirty (30) days' written notice from the insurer prior to any cancellation or change of coverage. Tenant shall deliver policies of such data records insurance or reports certificates thereof to Landlord on or before the said regulatory agency upon its requestCommencement Date, and thereafter at least thirty (30) days before the expiration dates of expiring policies. In the event Tenant shall fail to procure such insurance, or to deliver such policies or certificates, and after Landlord has notified Tenant, Landlord may, at its option, procure same for the account of Tenant, and the cost thereof shall be paid to Landlord as Additional Rent within five (5) days after delivery to Tenant of bills therefore. Tenant's compliance with the provisions of this Paragraph 10(c) shall in no way limit Tenant's liability under any of the other provisions of this Paragraph 10. (d) Tenant shall obtain and keep in force during the entire term of this Lease, fire insurance including extended coverage, vandalism and malicious mischief, upon property of every description and kind owned by Tenant and located in the Premises or the Building, or for which Tenant shall be legally liable, or which shall be installed by or on behalf of Tenant, including, without limitation, furniture, fixtures, equipment, leasehold improvements (other than the Standard Improvements) and alterations, in an amount not less than one hundred percent (100%) of the full replacement cost thereof. (e) Tenant shall obtain and maintain in full force and effect during the entire term of this Lease, and any extensions or renewals, business interruption insurance payable in case of a GCP inspectionloss resulting from damage to the Premises or the Building by fire or other casualty. Such insurance shall be maintained in an amount not less than the sum of all Annual Base Rent and additional rent coming due for the then current calendar year as estimated by Landlord. (f) Tenant shall not do or permit any activity to be done on the Premises, which shall be contrary to 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 provisions of any insurance policy which shall insure the Building or any property therein, or which shall cause the premiums for such inspection so as insurance to allow increase over standard premiums. Tenant shall reimburse Landlord and any other Tenants in the SPONSOR to be present to the inspection if he elects to be presentBuilding for increases in standard rates of insurance, 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 which 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 caused by activities 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 proceduresTenant.

Appears in 1 contract

Samples: Lease Agreement (Cardionet Inc)

Insurance and Indemnification. In accordance (a) The Partnership shall procure and maintain, at Partnership expense, programs of insurance coverage, including but not limited to comprehensive general liability, property damage, product liability, directors' and officers', fiduciary, fidelity, theft, burglary, worker's compensation, and business interruption insurance, as the General Partner from time to time shall determine, and with Applicable Lawssuch companies and with such terms, limits and deductibles as the General Partner from time to time shall determine. The Partnership, the SPONSOR Partners, the stockholders of the General Partner and any other entity which has an equity interest in the General Partner shall be named additional insureds thereunder, to the extent practicable. (i) The Partnership shall, to the fullest extent permitted by applicable law, indemnify any Person who was or is a party, or is threatened to be made a party, to any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative and whether formal or informal ("Proceeding"), by reason of the fact that the Person (y) is or was an officer of the Partnership, or (z) is or was serving at the request of the Partnership as a stockholder, director, officer, partner or trustee of another corporation, partnership, joint venture, trust, nonprofit entity, or other enterprise, including any employee benefit plan. Such indemnity shall include indemnification against any and all expenses, liability and loss (including, without implied limitation, attorneys' fees, judgments, fines, ERISA excise taxes or penalties and amounts paid in settlement) reasonably incurred or suffered by such Person in connection with such Proceeding. Such indemnity shall also include the right to have funds advanced by the Partnership for expenses, including attorneys' fees, as incurred in defending any Proceeding in advance of its final disposition. Notwithstanding the foregoing, however, the Partnership shall not be liable, even without faultresponsible or accountable for damages or otherwise liable hereunder to such Person for the gross negligence, for dishonesty, fraud, bad faith, breach of fiduciary duty or willful misconduct of such Person and any damage incurred by funds shall be advanced to a Study Participant orPerson hereunder only upon such Person's written undertaking to restore such funds to the Partnership should it be determined that the Partnership is not liable to such Person as herein provided. (ii) In addition to the foregoing, in the case Partnership shall unconditionally and absolutely hold each of deaththe Partners harmless from, his rightful claimantsand indemnify each of such Persons for, 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 damages, losses, obligations, penalties, liabilities, claims, actionsencumbrances, 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 deficiencies, costs, charges and expenses of any such complaintnature whatsoever (including, but not limited to, reasonable attorneys' fees and other costs and expenses) incident to any suit, action, investigation, 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 proceeding suffered, sustained, incurred 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/required to be paid by the SPONSOR (and/or CRO) any such Person relating to the INSTITUTION assets, property, business or obligations or liabilities of the Partnership or the Partnership's management, control, ownership and operation of the business of the Partnership and its assets; provided, however, that the foregoing shall not apply to any contractual obligation of any Partner undertaken pursuant to any of the Closing Documents. (iii) For purposes of this Section 6.3, an "Indemnified Party" shall be any Person who is in the class of Persons entitled to indemnification from the Partnership pursuant to this paragraph 6.3(b). (c) The following indemnification procedures shall apply: If any claim is asserted against any Indemnified Party to which the indemnifications contained in paragraph 6.3(b) hereof shall apply or to which any Indemnified Party proposes to assert that such indemnifications apply, then such Indemnified Party shall give prompt notice of the claim to the Partnership. The omission so to notify the Partnership shall not relieve the Partnership from any duty to indemnify which otherwise might exist with regard to such claim except to the extent the omission to notify materially prejudices the ability of the Partnership to assume the defense of such claim. After the Partnership has received notice from an Indemnified Party that a claim has been asserted against such Indemnified Party, the Partnership shall have the right, upon giving written notice to the Indemnified Party, to participate in the defense of such claim or to elect to assume the defense against the claim, at its own expense, through the Indemnified Party's attorney or an attorney selected by the Partnership satisfactory to the Indemnified Party, which approval shall not be unreasonably withheld. If the Partnership fails to give prompt notice of such election, the Partnership shall be deemed not to have elected to assume the defense of such claim and the Indemnified Party may defend against such claim with its own attorney. If the Partnership elects to participate in but not to assume the defense, the Indemnified Party shall have the right to make the final decision, in a reasonable manner, in all matters relating to such defense. The Indemnified Parry and the Partnership will cooperate and make available to each other (and their representatives) all employees, information, books and records reasonably necessary or useful in connection with such defense. In the event the Partnership shall have elected to assume the defense of a claim the Partnership shall have the sole right to compromise and settle in good faith any such claim. If the Partnership shall elect to defend or agree in writing to compromise or settle any such claim, it shall be bound by any ultimate judgment or settlement as to the existence and amount of the claim, and the amount of said judgment or settlement shall be conclusively deemed for all purposes of this Agreement to be a liability on account of which the Study under this Agreement; and Indemnified Party is entitled to be indemnified. If the Partnership does not elect or is deemed not to have elected to assume the defense of a claim: (i) The Indemnified Parry alone shall have the right to conduct such defense; (ii) The Indemnified Party shall have the right to compromise and settle the claim in aggregategood faith without the prior consent of the Partnership; and (iii) If it is ultimately determined that the claim of loss which shall form the basis of such judgment or settlement is one that is validly an obligation of the Partnership, an amount corresponding to [XX times] the aggregated fees paid/Partnership shall be bound by any ultimate judgment or to be paid by the SPONSOR (and/or CRO) settlement as to the INSTITUTION existence and amount of the claim, and the amount of said judgment or settlement shall be conclusively deemed 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 all purposes of this Agreement to be a liability on account of which the SPONSOR [Indemnified Party is entitled to be indemnified. (d) The rights of indemnification provided for in this Section 6.3 shall continue as to any Person who is no longer within the class of Persons entitled to indemnification pursuant to paragraph 6.3(b) hereof with respect to events occurring while such Person was part of such class and CRO jointly] shall terminate upon inure to the 10th (tenth) anniversary [or such other time as may be agreed upon by the Parties upon a case by case basis] benefit of the end heirs, executors, administrators, successors, legal representatives and permitted assigns, as the case may be, of the Study at the INSTITUTION any such Person. (e) The rights of indemnification provided for in accordance with the Protocol. Notwithstanding anything this Section 6.3 shall continue 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, [...]], exist after rescission 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 modification of this Agreement and provides upon request with respect to events occurring prior to such rescission or modification. (f) The rights of the SPONSOR indemnification provided for in this Section 6.3 shall be cumulative with 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 other right an Indemnified Party may have or may hereafter acquire under any law, any provision of this Agreement or otherwise, and provides upon request of any rights any such Person shall have may be asserted against the INSTITUTION any updated insurance certificate. All Parties shall promptly inform each other of any claims or imminent claims relating Partnership, without regard 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 (rights such consent not to be unreasonably withheld). For the avoidance of doubt, each Party shall be entitled to seek own counsel for any claims Person may have 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. 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 proceduresanother Person.

Appears in 1 contract

Samples: Limited Partnership Agreement (Nalco Energy Services Equatorial Guinea LLC)

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. 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

Appears in 1 contract

Samples: Office Lease Agreement (Ws Financing Corp)

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. 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.

Appears in 1 contract

Samples: Clinical Investigation Agreement

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. 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.

Appears in 1 contract

Samples: Clinical Trial 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 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. 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.

Appears in 1 contract

Samples: Clinical Research Agreement

Insurance and Indemnification. In accordance (a) Idera agrees to maintain in force at its sole cost and expense, with Applicable Lawsreputable insurance companies having an AM Best rating of A-VII or better, commercial general liability insurance in minimum amounts of [**] dollars ($[**]) per occurrence and [**] dollars ($[**]) in aggregate and clinical trial insurance in minimum amounts of [**] dollars ($[**]) per occurrence and [**] dollars ($[**]) in aggregate. Upon written request, Idera shall provide evidence of such insurance to AbbVie. Idera will provide AbbVie with written notice at least [**] days prior to the SPONSOR cancellation, non-renewal or material change in such insurance; if Idera does not obtain replacement insurance providing comparable coverage within such [**] day period, AbbVie shall be liablehave the right to terminate this Agreement immediately. Notwithstanding the foregoing, even without fault, for any damage incurred Idera may upon notice to AbbVie fulfill such requirements by a Study Participant or, in the case of death, his rightful claimants, that arises either in direct or indirect connection with the Study reasonable self-insurance program. Except for damages 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 claims (collectively the “Other Party’s Indemnitees”a) 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 (i) Idera’s breach of such Other PartySection 8 (Confidentiality) of this Agreement and (ii) Idera’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 that are directly attributable solely to the aggregated fees (excluding pass through costs) paid or/to be paid by the SPONSOR (and/or CRO) Idera Compound and not attributable to the INSTITUTION for AbbVie Compound or the Study under this Agreement; and (ii) AbbVie Compound 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 combination 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 lawIdera Compound, 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 total liability of Idera 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 exceed, in aggregate over the SPONSOR any updated insurance certificate. The SPONSOR declares Term, [**] dollars ($[**]). (b) AbbVie represents and warrants that it has maintains a civil liability policy or program of insurance policy which notably covers the SPONSOR or self-insurance at levels sufficient to support its obligations and its employees and undertakes to maintain such insurance policy throughout the term of liabilities assumed under 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 Applicable Laws, in particular towards Study subjects for Study Injury pursuant 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 withheldSection 2(f). For Upon written request, AbbVie shall provide evidence of such insurance to Idera. (c) AbbVie agrees to defend, indemnify and hold harmless Idera, its respective Affiliates, and its and their employees, directors, subcontractors and agents (collectively, the “Idera Indemnitees”) from and against any loss, damage, reasonable costs and expenses (including reasonable attorneys’ fees and expenses) incurred in connection with any claim, proceeding or investigation by a Third-Party including, for the avoidance of doubt, a Study subject (a “Liability”) to the extent that such Liability (A) was directly caused by (i) negligence, omission, or willful misconduct by any AbbVie Indemnitee (defined below); (ii) a breach by an AbbVie Indemnitee of any of its representations and warranties or any other covenants or obligations of AbbVie under this Agreement; (iii) a violation of any Applicable Law by an AbbVie Indemnitee with respect to the subject matter of this Agreement; (iv) Study Injuries resulting from administration of one or both AbbVie Compounds in the absence of the Idera Compound or the combination of Idera Compound and one or both AbbVie Compounds; or (B) is determined to be attributable to an AbbVie Compound; except to the extent in each case (A) or (B) that such Liability (1) was directly caused by (X) negligence or willful misconduct on the part of an Idera Indemnitee, (Y) a breach by an Idera Indemnitee of any of its respective representations and warranties or any other covenants or obligations of Idera under this Agreement, or (Z) a violation of Applicable Law by Idera in its performance under this Agreement; or (2) is determined to be attributable to the Idera Compound. (d) Idera agrees to defend, indemnify and hold harmless AbbVie, its respective Affiliates, and its and their employees, directors, subcontractors and agents (collectively, the “AbbVie Indemnitees”) from and against any Liability to the extent that such Liability (A) was directly caused by (i) negligence, omission, or willful misconduct by an Idera Indemnitee, (ii) a breach by an Idera Indemnitee of any of their respective representations and warranties or any other covenants or obligations of Idera under this Agreement, (iii) a violation of any Applicable Law by an Idera Indemnitee with respect to the subject matter of this Agreement; (iv) Study Injuries resulting solely from administration of the Idera Compound; or (B) is determined to be attributable to the Idera Compound; except to the extent in each case (A) or (B) that such Liability (1) was directly caused by (X) negligence or willful misconduct on the part of an AbbVie Indemnitee; (Y) a breach by an AbbVie Indemnitee of any of its representations and warranties or any other covenants or obligations of AbbVie under this Agreement; or (Z) a violation of Applicable Law by AbbVie in its performance under this Agreement Indemnitee; or (2) is determined to be attributable to an AbbVie Compound. (e) Each Party’s indemnification of the other Party is subject to the following conditions: (i) The indemnified Party shall be entitled provide notification to seek own the indemnifying Party, within [**] Business Days, of the indemnified Party’s first knowledge of the Third-Party claim giving rise to an indemnity obligation hereunder, provided that any failure to provide notice within such time period shall not relieve the indemnifying Party of its obligations of indemnification, holding harmless and defense with respect to such claim unless the indemnifying Party is materially prejudiced by such delay. Provided that the indemnifying Party is not contesting the indemnity obligation, the indemnified Party shall permit the indemnifying Party to control any litigation relating to such claim and allow the indemnifying Party to assume the defense of any such claim, including, without limitation, the right to select defense counsel for and the right to settle any claims or suits at its discretion. The indemnified Party may be represented by independent counsel of its choice and at its cost and expense. (ii) The indemnified Party shall cooperate with the indemnifying Party in the defense of any claim for which indemnification is sought hereunder. If the indemnifying Party fails to defend the claim within a reasonable time, the indemnified Party may assume the defense thereof, and the indemnifying Party will reimburse the indemnified Party for all expenses incurred in connection with such defense (including reasonable attorney’s fees, settlement payments, and payments of judgments) until the indemnifying Party assumes such defense. All rights of the indemnified Party against itself or its employees. Notwithstanding any Third-Party with respect to which a claim of indemnity was paid hereunder shall be subrogated to the provisions set out in Article 7.4, nothing indemnifying Party. (f) Nothing in this Article 7 Section 13 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 servants, agents or employees or to restrict or exclude any other liability of a either Party which cannot be so restricted or excluded in law. 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.

Appears in 1 contract

Samples: Clinical Trial Collaboration and Supply Agreement (Idera Pharmaceuticals, Inc.)

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”a) from any and all duly evidenced liabilities, claims, actions, or suits Except 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 Tenant Parties (as defined in case of gross negligence Paragraph 10(c) below) or wilful misconduct, [including Tenant’s breach of Sponsor Owned Inventions under Article 6.4.3this Lease, […][…] ], or where such limitation would be prohibited by mandatory provisions of law, the INSTITUTION’s total liability Landlord shall indemnify and indemnification obligation under this Agreement to the SPONSOR [hold Tenant harmless from and CRO jointly] under defend Tenant against any and all circumstances claims or liability 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 injury or damage to the aggregated any person or property including any reasonable attorney’s fees (but excluding pass through costsany consequential damages or loss of business) paid or/to be paid by the SPONSOR (and/or CRO) to the INSTITUTION for the Study under this Agreement; and (ii) in aggregateoccurring in, 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, [...]]on, or where such limitation would be prohibited by mandatory provisions of law, in no event shall either Party be liable as between about the Parties to the other for any indirect or consequential damages (including lost profits) Project to the extent not covered under the civil liability insurance policy arising out of the subject matter such injury 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 damage is caused by the negligence or willful misconduct of that Party Landlord, its agents, servants, contractors, employees (collectively, including Landlord, “Landlord Parties”) or its agents or employees or to restrict or exclude any other liability Landlord’s breach of a Party which canthis Lease. (b) Landlord shall not be so restricted liable to Tenant, and Tenant hereby waives all claims against Landlord Parties for any injury or excluded damage to any person or property in law. Upon request or about the Premises by or from any authorised officer cause whatsoever (other than the negligence or employee willful misconduct of Landlord Parties, including Landlord’s negligence or willful misconduct as related to construction or property management), and without limiting the generality of the foregoing, whether caused by water leakage of any relevant regulatory agencycharacter from the roof, walls, basement, or other government authorityportion of the Premises or the Building, or caused by gas, fire, oil, electricity, or any cause whatsoever, in, on, or about the Premises, the INSTITUTION and Building or any part thereof (other than that caused by the INVESTIGATOR are entitled and obliged negligence or willful misconduct of Landlord Parties). Tenant acknowledges that any casualty insurance carried by Landlord will not cover loss of income to permit such officers Tenant or employees, at reasonable times, damage to have access to and inspect and verify any data records and reports the alterations in the INSTITUTION's and/or Premises installed by Tenant or Tenant’s personal property located within the INVESTIGATOR's possession, custody or control relating Premises. Tenant shall be required to maintain the insurance described in Subparagraph 10(d) below during the Term. (c) Except 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 extent caused by the SPONSOR. Unless prohibited by law negligence or court orderwillful misconduct of Landlord Parties or Landlord’s breach of this Lease, the INSTITUTION Tenant shall indemnify and the INVESTIGATOR shall immediately inform the SPONSOR of hold Landlord harmless from and defend Landlord against any such inspection so as and all claims or liability for any injury or damage 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 person or have audited property whatsoever: (i) occurring in or on the INSTITUTION's fulfilment of its obligations hereunder (such as, but not limited to invoiced costs and expenses), and/or Premises; or (ii) the performance occurring in, on, or about any other portion of the Study Project to the extent such injury or damage shall be caused by the INVESTIGATORnegligence or willful misconduct by Tenant, its agents, servants, employees, or invitees (collectively, including Tenant, “Tenant Parties”). The SPONSOR Tenant further agrees to indemnify and hold Landlord harmless from, and defend Landlord against, any and all claims, losses, or liabilities (including damage to Landlord’s property) arising from (x) any breach of this Lease by Tenant and/or (y) the conduct of any work or business of Tenant Parties in or about the Project and/or (z) any matter referred to in Paragraph 10(g). This Paragraph 10 does not govern, liability for Hazardous Substances, which subject is governed by Paragraph 39 of the Lease concerning Hazardous Substance liability. (d) Tenant shall inform procure at its cost and expense and keep in effect during the INSTITUTION within Term the following insurance: (i) commercial general liability insurance including contractual liability with a reasonable timeline compatible minimum combined single limit of liability of Three Million Dollars ($3,000,000). Such insurance shall name Landlord as an additional insured, shall specifically include the liability assumed hereunder by Tenant, and shall provide that it is primary insurance, and not excess over or contributory with any other valid, existing, and applicable insurance in force for or on behalf of Landlord, and shall provide that Landlord shall receive thirty (30) days’ written notice from the insurer prior to any cancellation or change of coverage; (ii).“all: risk” property insurance (including, without limitation, boiler and machinery (if applicable); sprinkler damage, vandalism and malicious mischief) on all leasehold improvements installed in the Premises by Tenant at its expense (if any), and on all Tenant’s personal property. Such insurance shall be an amount equal to full replacement cost of the aggregate of the foregoing and shall provide coverage comparable to the coverage in the standard ISO All Risk form, when such form is supplemented with the clinical activity coverage’s required above; (iii) worker’s compensation insurance; and (iv) such other insurance as may be required by the law. Tenant shall deliver policies of such insurance or certificates thereof to Landlord on or before the Commencement Date, and thereafter at least thirty (30) days before the expiration dates of expiring policies; and, in the event Tenant shall fail to procure such insurance, or to deliver such policies or certificates, Landlord may, at its option, procure same for the account of Tenant, and the cost thereof shall be paid to Landlord as Additional Charges within five (5) days after delivery to Tenant of bills therefor. (e) The provisions of this paragraph 10 shall survive the expiration or termination of this Lease with respect to any claims or liability occurring prior to such expiration or termination. (f) Landlord shall maintain insurance on the Project against fire and risks covered by “all risk” (excluding earthquake and flood, though Landlord, at its option, may include this coverage) on a 100% of “replacement cost” basis (though reasonable deductibles may be included under such coverage). Landlord’s insurance shall also cover the improvements installed by Landlord prior to the commencement of the INVESTIGATOR Term, shall have a building ordinance provision, and INVESTIGATOR’s team. Upon request of SPONSOR, INSTITUTION and/or INVESTIGATOR shall provide for rental interruption insurance covering a period of twelve (12) full months. In no event shall Landlord be deemed a co-insurer under such policy. Landlord shall also maintain contractual liability coverage (or with contractual liability endorsement) on an occurrence basis in amounts not less than Three Million Dollars ($3,000,000) per occurrence with respect to SPONSOR copies bodily injury or death and property damage. Notwithstanding the foregoing obligations of all materialsLandlord to carry insurance, reportsLandlord may modify the foregoing coverages if and to the extent it is commercially reasonable to do so. (g) Tenant acknowledges that even if Landlord installs and operated security cameras or other security equipment and/or provides any other services that could be construed as being intended to enhance security, correspondence, statements, forms and records which INSTITUTION and/or INVESTIGATOR receives, obtains Landlord shall have no obligation to Tenant or generates pursuant to any inspection of Tenant’s employees, customers or invitees for any damage, claim, loss or liability related to any claim that Landlord had a duty to provide security or that the equipment or services provided by Landlord were inadequate, inoperative or otherwise failed to provide adequate security. Any such claim made against Landlord by any employee, customer or invitee of Tenant shall be included within Tenant’s obligation of indemnity and defense set forth 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 proceduressubparagraph (c) above.

Appears in 1 contract

Samples: Sublease (DemandTec, Inc.)

Insurance and Indemnification. In accordance with Applicable Laws(a) Tenant shall obtain, and shall keep in full force and effect during the Term, the SPONSOR following insurance coverages on a primary and non-contributory basis, with insurers which are authorized to do business in the State of New Jersey and which are rated at least A- VIII in Best’s Key Rating Guide: (i) commercial general liability insurance on an occurrence form (including, during any period when Tenant is making alterations or improvements to the Premises, coverage for any construction on or about the Premises), against claims for bodily injury, personal injury, death or property damage occurring on, in or about the Premises, or as a result of ownership of facilities located on the Premises, insurance premise operations and products and completed operations in an amount per occurrence of not less than Five Million Dollars ($5,000,000) combined single limit for any bodily injury, personal injury, death or property damage with a per location aggregate. The limit required may be achieved by the combination of general liability and umbrella / excess liability. Any umbrella / excess liability will provide coverage excess of the underlying CGL, Auto liability and employer’s liability insurance; (ii) workers’ compensation insurance coverage for the full statutory liability of Tenant and employers liability insurance coverage; (iii) business interruption insurance in such amounts as will reimburse Tenant for direct and indirect loss of earnings attributable to those events commonly insured against by reasonable prudent tenants and/or attributable to Tenant’s inability to access or to occupy (all or part of) the Premises; and (iv) Special Form coverage, including, but not limited to, standard fire and extended coverage insurance with vandalism and malicious mischief endorsements, on all personal property of Tenant and on all improvements and alterations made by, on behalf of and/or at the expense of Tenant in or about the Premises or other portions of the Building (including, without limitation, that portion of the Initial Tenant Improvements Work completed at the sole cost and expense of Tenant) to the extent of their full replacement value; and (v) comprehensive automobile liability insurance coverage, including hired and non-owned vehicles with a combined single limit of not less than $1,000,000. Tenant shall cause, via a written agreement, any contractor working for or on behalf of Tenant in or about the Premises to maintain the same levels of insurance as required of Tenant in this Section 8 as to coverage types, limits and terms. Such requirements shall include contractor adding Landlord and Landlord’s managing agent as additional insured per Section 8 (b), and contractor’s insurance being primary and non-contributory as respects those additional insureds, waiver of subrogation clauses as required of Tenant and contractor including and maintaining products and completed operations coverage for not less than 3 years after completion of work. Tenant and or contractor shall provide evidence of such insurance to Landlord prior to entering the Premises, prior to each renewal and otherwise upon such reasonable request by Landlord. (b) The policies of insurance required to be maintained by Tenant pursuant to Section 8(a) shall name Tenant as named insured and shall name Landlord and Landlord’s managing agent as additional insured parties (except for workers’ compensation insurance and business interruption insurance). In addition, said policies of insurance (except for worker’s compensation insurance) shall not contain a provision relieving the insurer thereunder of liability for any loss by reason of the existence of other policies of insurance covering the Premises against the peril involved, whether collectible or not; and the policies of insurance required to be maintained by Tenant pursuant to subsection (a) shall also include a contractual liability endorsement evidencing coverage of Tenant’s obligation to indemnify Landlord pursuant to Section 8(f)(ii) hereof. In addition to the foregoing, Landlord may, to the extent permitted by law, require that Tenant name as additional insureds such other persons or entities as Landlord may designate in writing, and original or duplicate policies evidencing the addition of such parties as additional insureds shall be liabledelivered to Landlord not later than ten (10) days following Landlord’s notice designating such additional insureds. (c) On or prior to the Commencement Date, even without faultTenant shall deliver to Landlord certificates of insurance evidencing all the insurance which is required to be maintained hereunder by Tenant, for and, within ten (10) days prior to the expiration of any damage incurred such insurance, other certificates evidencing the renewal of such insurance. (d) Tenant shall not obtain or carry separate insurance concurrent in form or contributing in the event of loss with that required by Section 8(a) unless Landlord and Tenant are named as insureds and additional insureds as applicable therein. (e) Landlord shall keep in force at its expense, insurance in such amounts, with such deductibles and covering such risks as are customarily carried by companies engaged in similar businesses and leasing similar properties to the Project. Such insurance will be with financially sound and reputable insurance companies. Further, the insurance coverages required by Landlord in this Section 8 may be provided by a Study Participant orblanket policy covering the Buildings, the Project, and other properties leased or owned by Landlord. (f) Landlord hereby waives and releases Tenant, and Tenant hereby waives and releases Landlord, from any and all liabilities, claims and losses for which the released party is or may be held liable to the extent of any insurance proceeds received by said injured party. Each party hereto shall have included in each of its insurance policies (insuring the Building in the case of deathLandlord, his rightful claimantsand insuring Tenant’s personal property, trade fixtures, equipment and improvements in the case of Tenant, against loss, damage or destruction by fire or other casualty) a waiver of the insurer’s right of subrogation against the other party to this Lease. If there is any extra charge for such waiver, the party requesting the waiver shall pay the extra charge therefor. If such waiver is not enforceable or is unattainable, then such insurance policy shall contain either an (A) express agreement that arises either such policy shall not be invalidated if Landlord or Tenant, whichever the case may be, waives the right of recovery against the other party to this Lease or (B) any other form for the release of Landlord or Tenant, whichever the case may be. If such waiver, agreement or release shall not be, or shall cease to be, obtainable from Landlord’s insurance company or from Tenant’s insurance company, whichever the case may be, then Landlord or Tenant shall notify the other party of such fact and shall use its best efforts to obtain such waiver, agreement or release from another insurance company satisfying the requirements of this Lease. (g) Subject to Sections 8 (f) and (i), Tenant hereby indemnifies, and shall pay, protect and hold Landlord harmless from and against all liabilities, losses, claims, demands, costs, expenses (including reasonable attorneys’ fees and expenses) and judgments of any nature, (except to the extent Landlord is compensated by insurance maintained by Landlord or Tenant hereunder and except for such of the foregoing as arise from the negligence, recklessness or willful misconduct of Landlord, its agents, servants or employees), arising, or alleged to arise, from or in direct or indirect connection with (a) any breach or default in the Study performance of any obligation of Tenant to be performed under the terms of this Lease, (b) any act or negligence of Tenant, or any of Tenant’s Agents, arising from any activity, work or things done by Tenant, or any of Tenant’s Agents, in or about the Project, or (c) Tenant’s use of the Project, or from the conduct of Tenant’s business in or about the Project. Tenant will resist and defend any action, suit or proceeding brought against Landlord by reason of any such occurrence by independent counsel selected by Tenant, which is reasonably acceptable to Landlord. The obligations of Tenant under this Section 8(g) shall survive any termination of this Lease. (h) Subject to Sections 8 (f) and (i), Landlord hereby indemnifies, and shall provide compensation thereforepay, protect and hold Tenant harmless from and against all liabilities, losses, claims, demands, costs, expenses (including reasonable attorneys’ fees and expenses) and judgments of any nature, (except to the extent Tenant is compensated by insurance maintained by Landlord or Tenant hereunder and except for such of the foregoing as arise from the negligence, recklessness or willful misconduct of Tenant or Tenant’s agents), arising, or alleged to arise, from or in connection with (a) any breach or default in the performance of any obligation of Landlord to be performed under the terms of this Lease, or (b) any act or negligence of Landlord, or any of its agents, servants or employees, arising from any activity, work or things done by Landlord, or any of its agents, servants or employees, in or about the Project. Landlord will resist and defend any action, suit or proceeding brought against Tenant by reason of any such occurrence by independent counsel selected by Landlord, which is reasonably acceptable to Tenant. The SPONSOR obligations of Landlord under this Section 8(h) shall enter into an insurance contract in accordance with Applicable Laws. Each Partysurvive any termination of this Lease. (i) Notwithstanding any provision contained herein to the contrary, shall indemnify Landlord and hold harmless Tenant each hereby waives any and all rights of recovery, claims, actions or causes of action against the other, its agents and employees (collectively the “Other Party’s Indemnitees”) from any and all duly evidenced liabilitiesagents, claimsservants, actionspartners, shareholders, officers, or suits employees, for any loss or damage that may occur to the extent caused by its negligence or wrongful acts or omissions; Premises, the Buildings, the Common Areas, the parking areas or the negligence Project, or wrongful acts any improvements thereto, or omissions any personal property of its agents such party therein, caused or employees pertaining to occasioned by any peril which is or could be insured under the activities special form coverage insurance policies required to be carried out pursuant to the obligations by any party 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, […][…] ]Lease, or where such limitation would be prohibited by mandatory provisions which is otherwise insured, regardless of lawcause or origin, 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 negligence 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 doubtparty hereto, each Party shall be entitled to seek own counsel for any claims against itself or its employees. Notwithstanding the provisions set out in Article 7.4agents, 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. Upon request by any authorised officer or employee of any relevant regulatory agencyofficers, or other government authoritypartners, the INSTITUTION and the INVESTIGATOR are entitled and obliged to permit such officers shareholders, servants or employees, at reasonable times, to have access to and inspect and verify any data records and reports in Tenant shall require 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 same from 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 procedurescontactors.

Appears in 1 contract

Samples: Lease Agreement (INSMED Inc)

Insurance and Indemnification. In accordance with Applicable Laws, the SPONSOR (a) Landlord shall not be liable, even without fault, liable to Tenant except for Landlord's own grossnegligence. Tenant hereby waives all claims against Landlord for any injury or damage incurred to any person or property in or about the Premises by a Study Participant oror from any cause whatsoever, in including without limitation, damage caused by water leakage of any character from the case roof, walls, pipes, basement or other portion of deaththe Premises or the Building, his rightful claimantsor caused by gas, that arises either in direct fire, oil, electricity or indirect connection with any cause whatsoever, in, on or about the Study and Premises or the Building or any part thereof. (b) Tenant shall provide compensation therefore. The SPONSOR shall enter into an insurance contract in accordance with Applicable Laws. Each Partyindemnify, shall indemnify defend and hold Landlord harmless the other, its agents and employees (collectively the “Other Party’s Indemnitees”) from any and all duly evidenced liabilitiesclaims or liability for any injury or damage to any person or property whatsoever, claims, actions, or suits unless and to the extent that such claims or liability are due to Landlord's own grossnegligence, which claims shall occur on or about the Premises (including the Building Common Areas), or on or about the Office Park (including common areas thereof), when such injury or damage shall be caused in whole or in part by the act, failure to act, neglect or fault of Tenant, its negligence agents, servants, employees 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 Agreementinvitees. Each Party Tenant 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 further indemnify and hold Landlord 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 any default by Tenant in the Study performance of any covenant to be performed by Tenant pursuant to this Lease or which shall arise from any act or negligence of Tenant, or any of its agents, contractors, servants, employees or licensees, and from and against all costs, counsel fees, and expenses which Landlord shall incur in connection with any adverse reaction in direct such claim or indirect connection with the Studyaction or proceeding brought thereon. In case of gross negligence or willful misconduct of the INVESTIGATOR and/or INSTITUTIONFurthermore, the SPONSOR may seek recourse against the INVESTIGATOR and/or the INSTITUTION. Except in case of gross negligence any action or wilful misconduct, [including breach of Sponsor Owned Inventions under Article 6.4.3, […][…] ], or where such limitation would proceeding shall be prohibited brought against Landlord 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 reason of any claims or imminent liabilities not due to Landlord's own grossnegligence, Tenant shall defend such action or proceeding at Tenant's sole expense by counsel chosen by Landlord and reasonably satisfactory to Tenant. The provisions of this Paragraph 10 shall survive the expiration or termination of this Lease with respect to any claims relating or liability occurring prior to such expiration or termination. (c) Tenant shall procure at its cost and expense, and shall keep in effect during the conduct term of the Study. No admission or settlements in respect Lease, comprehensive general liability insurance including contractual liability with a minimum combined single limit of the alleged liability of the other Party shall be made without greater of the prior written approval of that Party amount required in the Basic Lease Information, or One Million Dollars (such consent not to be unreasonably withheld$ 1,000,000.00). For The insurance required by this Paragraph 10(c) shall name Landlord as an additional insured, shall specifically include the avoidance liability assumed hereunder by Tenant (provided that the amount of doubt, each Party such insurance shall not be entitled construed 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 limit the liability of any Party vis-à-vis the Study Participants in relation to their death Tenant hereunder), and shall provide that it is primary insurance, and not excess over or personal injury caused by the negligence of that Party or its agents or employees or to restrict or exclude contributory with any other liability valid, existing and applicable insurance in force for or on behalf of a Party which cannot be so restricted or excluded in law. Upon request by any authorised officer or employee of any relevant regulatory agencyLandlord, 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 provide that Landlord shall receive thirty (30) days' written notice from the insurer prior to any cancellation or change of coverage. Tenant shall deliver policies of such data records insurance or reports certificates thereof to Landlord on or before the said regulatory agency upon its requestCommencement Date, and thereafter at least thirty (30) days before the expiration dates of expiring policies. In the event Tenant shall fail to procure such insurance, or to deliver such policies or certificates, and after Landlord has notified Tenant, Landlord may, at its option, procure same for the account of Tenant, and the cost thereof shall be paid to Landlord as Additional Rent within five (5) days after delivery to Tenant of bills therefore. Tenant's compliance with the provisions of this Paragraph 10(c) shall in no way limit Tenant's liability under any of the other provisions of this Paragraph 10. (d) Tenant shall obtain and keep in force during the entire term of this Lease, fire insurance including extended coverage, vandalism and malicious mischief, upon property of every description and kind owned by Tenant and located in the Premises or the Building, or for which Tenant shall be legally liable, or which shall be installed by or on behalf of Tenant, including, without limitation, furniture, fixtures, equipment, leasehold improvements (other than the Standard Improvements) and alterations, in an amount not less than one hundred percent (100%) of the full replacement cost thereof. (e) Tenant shall obtain and maintain in full force and effect during the entire term of this Lease, and any extensions or renewals, business interruption insurance payable in case of a GCP inspectionloss resulting from damage to the Premises or the Building by fire or other casualty. Such insurance shall be maintained in an amount not less than the sum of all Annual Base Rent and additional rent coming due for the then current calendar year as estimated by Landlord. (f) Tenant shall not do or permit any activity to be done on the Premises, which shall be contrary to 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 provisions of any insurance policy which shall insure the Building or any property therein, or which shall cause the premiums for such inspection so as insurance to allow increase over standard premiums. Tenant shall reimburse Landlord and any other Tenants in the SPONSOR to be present to the inspection if he elects to be presentBuilding for increases in standard rates of insurance, 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 which 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 caused by activities 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 proceduresTenant.

Appears in 1 contract

Samples: Lease Agreement (Cardionet Inc)

Insurance and Indemnification. In accordance with Applicable Laws7.1 Each party (the"Indemnitor") shall indemnify, 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 save and hold harmless the other, its agents and employees other party (collectively the “Other Party’s Indemnitees”"Indemnitee") from and against any and all duly evidenced liabilitiesjudgments, claimsdamages, actionscosts and expenses, including reasonable attorney's fees, paid or incurred by the Indemnitee in any claim, action or proceeding for damage to property, injury or death to person, or suits to otherwise, arising solely out of the extent caused by its negligence or wrongful acts or omissions; or the negligence or wrongful proven negligent acts or omissions of its agents or employees pertaining to the activities to be carried out pursuant to the obligations Indemnitor in Indemnitor's performance under this Agreement. Each Party Indemnitee obligations as set forth in the preceding sentence are conditioned upon (i) Indemnitee promptly notifying Indemnitor of any claim, demand or action, or any incident of which Indemnitee has actual and constructive knowledge, which may reasonably result in a claim, demand or action, and for which Imdemnite will look to Indemnitor for indemnification under this Section, (ii) Indemnitee, its directors, officers, employees and servants, shall promptly notify the other reasonably and in writing good-faith cooperate with Indemnitor in Indemnitor's investigation and review of any such complaintclaim, demand, action or incident, and (iii) Indemnitee not entering into any admissions, agreements or settlements which may affect the rights of Indemnitee or Indemnitor without the prior written consent and approval of Indemnitor. Indemnitor reserves the right, in its sole discretion, to assume the defense of Indemnitee in any such claim, action or proceeding. 7.2 The Indemnitee shall have the right to employ separate counsel in any such action and to participate in the defense thereof, but the fees and expenses of such counsel shall be at the expense of such Indemnitee unless (a) employment of such counsel and payment of the fees and expenses thereof by the Indemnitor has been specifically authorized by the Indemnitor, or (b) in the reasonable judgment of such Indemnitee, employment of such counsel is necessary because the claim or injury relating defense for which such counsel is employed is inconsistent or in conflict with the claims or defenses of the Indemnitor, or (c) the Indemnitee shall have reasonably concluded that there may be claims or defenses available to it that are different from or in addition to those available to the Indemnitor, in any loss subject of which events such fees and expenses shall be borne by the Indemnitor, but in any such event, the Indemnitor shall not have the right to this indemnificationdirect the defense of such action on behalf of the Indemnitee. Neither Party The Indemnitor shall indemnify not be liable for any settlement of any such action effected without the Indemnitor's consent by the Indemnitee, but if settled with consent of the Indemnitor or if there shall be a final judgment for the plaintiff in such action against the Indemnitee or the Indemnitor with or without the consent of Indemnitor, the Indemnitor agrees to indemnity 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) Indemnitee 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 provided herein. 7.3 Each party shall procure and undertakes to maintain such insurance policy throughout for 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 professional liability insurance policy which notably covers in a minimum amount of $3,000,000 per incident/$3,000,000 annual aggregate. Each party shall also provide the SPONSOR and its employees and undertakes to maintain such insurance policy throughout other with certificate or affidavit of said coverage. Each party will notify 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 cancellation 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. 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.significant change thirty

Appears in 1 contract

Samples: Management Agreement (Renal Care Group Inc)

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