Indemnification and Warranties. 9.1 CRO shall defend, indemnify and hold harmless SPONSOR, its affiliated entities, and their respective trustees, officers, agents and employees from any and all losses, costs, expenses, liabilities, claims, actions and damages, directly and objectively attributable to the responsibility of CRO in the conduction of the Project and/or performance of the Services including without limitations, the failure to strictly comply with the Protocol, with good clinical practices, with Service timelines, with SPONSOR's written recommendations and instructions relative to the conduct of the Project, or with any applicable law, regulations or authority’s requirements, subject to the restrictions set forth in articles 9.2 and 9.3 below. 9.2 The above obligation of CRO shall not apply nor shall CRO be liable for any indemnification or expenses, and in fact, SPONSOR shall defend, indemnify, and hold harmless CRO, for actions or claims in any way arising from or caused by the wilful misconduct or gross negligence of SPONSOR or arising from or caused by any of its failures to comply with this Agreement. 9.3 The obligation of the indemnifying party hereunder, in connection with a third party claim or suit, shall apply only if the other party provides prompt written notification upon receipt of notice of any claim or suit (provided, however, that neither party shall be released from its obligations under this Section 9 if the failure to promptly notify the other party does not materially prejudice the defence of any claim), permits the indemnifying party and its attorneys and personnel to handle and control the defence of such claims or suits, including pre-trial, trial or settlement, and the indemnified party fully cooperates and assists in such defence. The indemnified party further agrees that it will not settle or compromise any such claim or suit without the prior written consent of the indemnifying party. 9.4 The parties shall secure and maintain in full force and effect through the performance of the Project (and following termination of the applicable Study to cover any claims arising from the applicable Study) insurance coverage in amounts appropriate to the conduct of the Project and the Services contemplated by the applicable Project, and shall provide evidence of insurance coverage in an acceptable form upon request. 9.5 In the event any breach or default by any of the Party of this Agreement with respect to its obligations under this Agreement, the respective Party’s damage liability to the other Party for such breach or default shall be limited to emerging damages (i.e. “danno emergente” under Italian law), except in case of losses sought or awarded for death or bodily injury for which such limitation shall not apply. 9.6 CRO represents and warrants that this Agreement will be performed in material compliance with all applicable laws and regulations, including without limitation, laws and regulations relating to health, safety and environment, fair labour practices, unlawful discrimination. 9.7 CRO shall maintain/extend/renew, for the entire duration of this Agreement, the approval by the French Ministry of Higher Education and Research mentioned in the premises of this agreement (the “French Ministry Approval”). Without limitation of the foregoing, CRO shall make all filings and take all actions needed in order to maintain/extend/renew the French Ministry Approval and use its best effort thereto. In case the French Ministry Approval is not maintained/extended/renewed for the entire duration of the Agreement, due to responsibility directly and objectively attributable to CRO, CRO shall pay to SPONSOR – also by way of set off with any amount due by SPONSOR to CRO under this agreement - as forfeiture (“penale” under Italian law), per each year in which the French Ministry Approval is not maintained/extended/renewed, 30% of the Services Fees invoiced in the reference year. The above is provided that, in case the French Ministry Approval is not maintained/extended/renewed due to changes in the applicable legislation that prevent CRO to obtain it, the above provided forfeiture shall not apply.
Appears in 2 contracts
Samples: Clinical Services Agreement (Advanced Accelerator Applications S.A.), Clinical Services Agreement (Advanced Accelerator Applications S.A.)
Indemnification and Warranties. 9.1 CRO 7.1 INDEMNIFICATIONS
(a) SBCL INDEMNIFICATION
(i) SBCL shall defend, indemnify and hold harmless SPONSORPROGENITOR, its affiliated entitiesAFFILIATES, and its and their respective trustees, officers, agents directors, employees, agents, successors and employees assigns from any and all lossesloss, costsdamage, expensesor liability, liabilitiesincluding reasonable attorney's fees, claimsresulting from any claim, actions and damagescomplaint, directly and objectively attributable suit, proceeding or cause of action against any of them alleging physical or other injury, including death, rising out of the provision of an ASSAY, or services utilizing an ASSAY, to the responsibility injured party by SBCL, its AFFILIATES, (or its permitted sublicensees); provided that: * Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with the Commission.
(A) SBCL shall not be obligated under this Section 7.1(a) if it is shown by evidence acceptable in a court of CRO in law having jurisdiction over the conduction subject matter and meeting the appropriate degree of proof for such action, that the injury was the result of the Project and/or performance negligence or willful misconduct of any employee or agent of PROGENITOR or the Services including without limitations, the failure to strictly comply with the Protocol, with good clinical practices, with Service timelines, with SPONSOR's written recommendations and instructions relative to the conduct breach of the Project, any warrant or with any applicable law, regulations or authority’s requirements, subject to the restrictions set forth representation made by PROGENITOR in articles 9.2 and 9.3 below.this AGREEMENT;
9.2 The above (B) SBCL shall have no obligation of CRO shall not apply nor shall CRO be liable for any indemnification or expenses, and in fact, SPONSOR shall defend, indemnify, and hold harmless CRO, for actions or claims in any way arising from or caused by the wilful misconduct or gross negligence of SPONSOR or arising from or caused by any of its failures to comply with under this Agreement.
9.3 The obligation of the indemnifying party hereunder, in connection with a third party claim or suit, shall apply only if the other party provides Section 7.1(a) unless PROGENITOR (i) gives SBCL prompt written notification upon receipt of notice of any claim or suit lawsuit or other action for which it seeks to be indemnified under this AGREEMENT, (ii) SBCL is granted full authority and control over the defense, including settlement, against such claim or lawsuit or other action, and (iii) PROGENITOR cooperates fully with SBCL and its agents in defense of the claims or lawsuit or other action; and
(C) PROGENITOR shall have the right to participate in the defense of any such claim, complaint, suit, proceeding or cause of action referred to in this Section 7.1(a) utilizing attorneys of its choice, at its own expense, provided, however, that neither party SBCL shall be released from its obligations have full authority and control to handle any such claim, complaint, suit, proceeding or cause of action, including any settlement or other disposition thereof, for which PROGENITOR seeks indemnification under this Section 9 if the failure to promptly notify the other party does not materially prejudice the defence of any claim), permits the indemnifying party and its attorneys and personnel to handle and control the defence of such claims or suits, including pre-trial, trial or settlement, and the indemnified party fully cooperates and assists in such defence. The indemnified party further agrees that it will not settle or compromise any such claim or suit without the prior written consent of the indemnifying partySection.
9.4 The parties shall secure and maintain in full force and effect through the performance of the Project (and following termination of the applicable Study to cover any claims arising from the applicable Study) insurance coverage in amounts appropriate to the conduct of the Project and the Services contemplated by the applicable Project, and shall provide evidence of insurance coverage in an acceptable form upon request.
9.5 In the event any breach or default by any of the Party of this Agreement with respect to its obligations under this Agreement, the respective Party’s damage liability to the other Party for such breach or default shall be limited to emerging damages (i.e. “danno emergente” under Italian law), except in case of losses sought or awarded for death or bodily injury for which such limitation shall not apply.
9.6 CRO represents and warrants that this Agreement will be performed in material compliance with all applicable laws and regulations, including without limitation, laws and regulations relating to health, safety and environment, fair labour practices, unlawful discrimination.
9.7 CRO shall maintain/extend/renew, for the entire duration of this Agreement, the approval by the French Ministry of Higher Education and Research mentioned in the premises of this agreement (the “French Ministry Approval”). Without limitation of the foregoing, CRO shall make all filings and take all actions needed in order to maintain/extend/renew the French Ministry Approval and use its best effort thereto. In case the French Ministry Approval is not maintained/extended/renewed for the entire duration of the Agreement, due to responsibility directly and objectively attributable to CRO, CRO shall pay to SPONSOR – also by way of set off with any amount due by SPONSOR to CRO under this agreement - as forfeiture (“penale” under Italian law), per each year in which the French Ministry Approval is not maintained/extended/renewed, 30% of the Services Fees invoiced in the reference year. The above is provided that, in case the French Ministry Approval is not maintained/extended/renewed due to changes in the applicable legislation that prevent CRO to obtain it, the above provided forfeiture shall not apply.
Appears in 1 contract
Samples: License Agreement (Progenitor Inc)
Indemnification and Warranties. 9.1 CRO A. INDEMNIFICATION EMERGE and HEMISPHERX (each an "Indemnifying Party") shall defendindemnify, indemnify defend and hold harmless SPONSORand the other Party's subsidiaries or affiliates, its affiliated entitiestheir agents, and their respective trusteesdirectors, officers, agents employees and employees assigns (the "Indemnified Parties") from any and against all losses, costs, expenses, liabilities, claims, actions and damages, directly demands and objectively attributable to the responsibility of CRO in the conduction of the Project and/or performance of the Services expenses (including without limitationsreasonable attorneys' fees and expenses) arising out of, the failure to strictly comply with the Protocol, with good clinical practices, with Service timelines, with SPONSOR's written recommendations and instructions relative to the conduct of the Projectas a result of, or with any applicable law, regulations or authority’s requirements, subject to the restrictions set forth in articles 9.2 and 9.3 below.
9.2 The above obligation of CRO shall not apply nor shall CRO be liable for any indemnification or expenses, and in fact, SPONSOR shall defend, indemnify, and hold harmless CRO, for actions or claims in any way arising from or caused by the wilful misconduct or gross negligence of SPONSOR or arising from or caused by any of its failures to comply with this Agreement.
9.3 The obligation of the indemnifying party hereunder, in connection with a (i) the negligent actions of the Indemnifying Party, its employees or any third party claim acting on behalf of or suit, shall apply only if under authority of the other party provides prompt written notification upon receipt Indemnifying Party in the performance of notice this Agreement and/or (ii) the violation of any claim representation or suit (provided, however, that neither party shall be released from its warranty of Indemnifying Party in this Agreement. Each Party's obligations under this Section 9 if the failure to promptly notify the other party does not materially prejudice the defence of any claim), permits the indemnifying party and its attorneys and personnel to handle and control the defence of such claims or suits, including pre-trial, trial or settlement, and the indemnified party fully cooperates and assists in such defence. The indemnified party further agrees that it will not settle or compromise any such claim or suit without the prior written consent of the indemnifying party.
9.4 The parties provision shall secure and maintain in full force and effect through the performance of the Project (and following termination of the applicable Study to cover any claims arising from the applicable Study) insurance coverage in amounts appropriate to the conduct of the Project and the Services contemplated by the applicable Project, and shall provide evidence of insurance coverage in an acceptable form upon request.
9.5 In the event any breach or default by any of the Party of this Agreement with respect to its obligations under this Agreement, the respective Party’s damage liability be subject to the other Party for providing reasonable notice of any such breach claim. Each Party shall defend with competent counsel and pay all costs of defence, including attorneys' fees, and any and all damages and court costs awarded in respect to such claim, action or default shall be limited proceeding regarding the claim of infringement. The Indemnified Parties agree to emerging damages (i.e. “danno emergente” under Italian law)permit the Indemnifying Party to defend, except in case of losses sought compromise, or awarded for death settle any such claim, action or bodily injury for which such limitation shall not apply.
9.6 CRO represents proceeding and warrants that this Agreement further agree to provide all available information, and reasonable assistance to enable the other Indemnifying Party to do so. However, neither party will be performed in material compliance with all applicable laws and regulationsliable under this indemnity for any losses, including without limitationliabilities, laws and regulations relating to healthdamages, safety and environment, fair labour practices, unlawful discrimination.
9.7 CRO shall maintain/extend/renew, for the entire duration of this Agreement, the approval by the French Ministry of Higher Education and Research mentioned in the premises of this agreement (the “French Ministry Approval”). Without limitation demands or expenses arising out of the foregoing, CRO shall make all filings and take all actions needed in order to maintain/extend/renew the French Ministry Approval and use its best effort thereto. In case the French Ministry Approval is not maintained/extended/renewed for the entire duration gross negligence or wilful misconduct of the Agreementother party or any of its affiliates, due to responsibility directly and objectively attributable to CROagents, CRO shall pay to SPONSOR – also by way directors, officers, employees or assigns. Limitation of set off with any amount due by SPONSOR to CRO under this agreement - as forfeiture (“penale” under Italian law)Liability. IN NO EVENT WILL EITHER PARTY BE LIABLE FOR ANY INCIDENTAL, per each year in which the French Ministry Approval is not maintained/extended/renewed, 30% of the Services Fees invoiced in the reference year. The above is provided that, in case the French Ministry Approval is not maintained/extended/renewed due to changes in the applicable legislation that prevent CRO to obtain it, the above provided forfeiture shall not applySPECIAL OR CONSEQUENTIAL DAMAGES RESULTING FROM THE LICENSE GRANTED PURSUANT TO THIS AGREEMENT OR THE USE OR COMMERCIAL DEVELOPMENT OF ALFERON.
Appears in 1 contract
Samples: Sales, Marketing, Distribution, and Supply Agreement (Hemispherx Biopharma Inc)
Indemnification and Warranties. 9.1 CRO A. INDEMNIFICATION SCIEN and HEMISPHERX (each an "Indemnifying Party") shall defendindemnify, indemnify defend and hold harmless SPONSORand the other Party's subsidiaries or affiliates, its affiliated entitiestheir agents, and their respective trusteesdirectors, officers, agents employees and employees assigns (the "Indemnified Parties") from any and against all losses, costs, expenses, liabilities, claims, actions and damages, directly demands and objectively attributable to the responsibility of CRO in the conduction of the Project and/or performance of the Services expenses (including without limitationsreasonable attorneys' fees and expenses) arising out of, the failure to strictly comply with the Protocol, with good clinical practices, with Service timelines, with SPONSOR's written recommendations and instructions relative to the conduct of the Projectas a result of, or with any applicable law, regulations or authority’s requirements, subject to the restrictions set forth in articles 9.2 and 9.3 below.
9.2 The above obligation of CRO shall not apply nor shall CRO be liable for any indemnification or expenses, and in fact, SPONSOR shall defend, indemnify, and hold harmless CRO, for actions or claims in any way arising from or caused by the wilful misconduct or gross negligence of SPONSOR or arising from or caused by any of its failures to comply with this Agreement.
9.3 The obligation of the indemnifying party hereunder, in connection with a (i) the negligent actions of the Indemnifying Party, its employees or any third party claim acting on behalf of or suit, shall apply only if under authority of the other party provides prompt written notification upon receipt Indemnifying Party in the performance of notice this Agreement and/or (ii) the violation of any claim representation or suit (provided, however, that neither party shall be released from its warranty of Indemnifying Party in this Agreement. Each Party's obligations under this Section 9 if the failure to promptly notify the other party does not materially prejudice the defence of any claim), permits the indemnifying party and its attorneys and personnel to handle and control the defence of such claims or suits, including pre-trial, trial or settlement, and the indemnified party fully cooperates and assists in such defence. The indemnified party further agrees that it will not settle or compromise any such claim or suit without the prior written consent of the indemnifying party.
9.4 The parties provision shall secure and maintain in full force and effect through the performance of the Project (and following termination of the applicable Study to cover any claims arising from the applicable Study) insurance coverage in amounts appropriate to the conduct of the Project and the Services contemplated by the applicable Project, and shall provide evidence of insurance coverage in an acceptable form upon request.
9.5 In the event any breach or default by any of the Party of this Agreement with respect to its obligations under this Agreement, the respective Party’s damage liability be subject to the other Party for providing reasonable notice of any such breach claim. Each Party shall defend with competent counsel and pay all costs of defence, including attorneys' fees, and any and all damages and court costs awarded in respect to such claim, action or default shall be limited proceeding regarding the claim of infringement. The Indemnified Parties agree to emerging damages (i.e. “danno emergente” under Italian law)permit the Indemnifying Party to defend, except in case of losses sought compromise, or awarded for death settle any such claim, action or bodily injury for which such limitation shall not apply.
9.6 CRO represents proceeding and warrants that this Agreement further agree to provide all available information, and reasonable assistance to enable the other Indemnifying Party to do so. However, neither party will be performed in material compliance with all applicable laws and regulationsliable under this indemnity for any losses, including without limitationliabilities, laws and regulations relating to healthdamages, safety and environmentdemands or expenses arising out of the gross negligence or wilful misconduct of the other party or any of its affiliates, fair labour practicesagents, unlawful discrimination.
9.7 CRO shall maintain/extend/renewdirectors, for the entire duration officers, employees or assigns. Limitation of Liability. IN NO EVENT WILL EITHER PARTY BE LIABLE FOR ANY INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES RESULTING FROM THE LICENSE GRANTED PURSUANT TO THIS AGREEMENT OR THE USE OR COMMERCIAL DEVELOPMENT OF PRODUCT. {***} Confidential portions of this Agreement, exhibit have been redacted and filed separately with the approval by the French Ministry of Higher Education and Research mentioned Commission pursuant to a confidential treatment request in the premises of this agreement (the “French Ministry Approval”). Without limitation accordance with Rule 24b-2 of the foregoingSecurities Exchange Act of 1934, CRO shall make all filings and take all actions needed in order to maintain/extend/renew the French Ministry Approval and use its best effort thereto. In case the French Ministry Approval is not maintained/extended/renewed for the entire duration of the Agreement, due to responsibility directly and objectively attributable to CRO, CRO shall pay to SPONSOR – also by way of set off with any amount due by SPONSOR to CRO under this agreement - as forfeiture (“penale” under Italian law), per each year in which the French Ministry Approval is not maintained/extended/renewed, 30% of the Services Fees invoiced in the reference year. The above is provided that, in case the French Ministry Approval is not maintained/extended/renewed due to changes in the applicable legislation that prevent CRO to obtain it, the above provided forfeiture shall not applyamended.
Appears in 1 contract
Samples: Sales, Marketing, Distribution, and Supply Agreement
Indemnification and Warranties. 9.1 CRO A. INDEMNIFICATION SCIEN and HEMISPHERX (each an "Indemnifying Party") shall indemnify, defend and hold harmless and the other Party's subsidiaries or affiliates, their agents, directors, officers, employees and assigns (the "Indemnified Parties") from and against all losses, liabilities, damages, demands and expenses (including reasonable attorneys' fees and expenses) arising out of, as a result of, or in connection with (i) the negligent actions of the Indemnifying Party, its employees or any third party acting on behalf of or under authority of the Indemnifying Party in the performance of this Agreement and/or (ii) the violation of any representation or warranty of Indemnifying Party in this Agreement. Each Party's obligations under this provision shall be subject to the other Party providing reasonable notice of any such claim. Each Party shall defend with competent counsel and pay all costs of defence, including attorneys' fees, and any and all damages and court costs awarded in respect to such claim, action or proceeding regarding the claim of infringement. The Indemnified Parties agree to permit the Indemnifying Party to defend, compromise, or settle any such claim, action or proceeding and further agree to provide all available information, and reasonable assistance to enable the other Indemnifying Party to do so. However, neither party will be liable under this indemnity for any losses, liabilities, damages, demands or expenses arising out of the gross negligence or wilful misconduct of the other party or any of its affiliates, agents, directors, officers, employees or assigns. Limitation of Liability. IN NO EVENT WILL EITHER PARTY BE LIABLE FOR ANY INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES RESULTING FROM THE LICENSE GRANTED PURSUANT TO THIS AGREEMENT OR THE USE OR COMMERCIAL DEVELOPMENT OF PRODUCT.
B. WARRANTIES Subject as herein provided HEMISPHERX warrants to SCIEN that: · All Product(s) supplied hereunder will comply with the Dossier and with any specification agreed for them in the Quality Agreement; · It is not aware of any rights of any third party in the Territory which would or might render the sale of the Product, or the use of any of the Trademarks on or in relation to the Products, unlawful; · It is the owner or the permitted licensee of all Intellectual Property Rights and it is not aware of any claims of any third party in the Territory or worldwide related to the fact that the Products infringes any intellectual property of such third party. · Nothing in this Agreement shall exclude either party’s liability for death or personal injury. Subject to the above WARRANTIES, HEMISPHERX shall indemnify and hold harmless SPONSOR, SCIEN and its affiliated entities, and their respective trustees, officers, agents and employees from any loss, damage or claim made by a third party in respect of (i) the death or personal injury arising from the manufacture or use of the Products in the Territory or (ii) infringement of third party intellectual property, if and all losses, costs, expenses, liabilities, claims, actions and damages, directly and objectively attributable to the responsibility extent such loss, damage or claim is caused by any act or omission of CRO in HEMISPHERX and is not attributable directly or indirectly to the conduction breach of any of the Project and/or performance material terms of the Services including without limitationsthis Agreement by SCIEN or by any wilful default or negligent act or omission of SCIEN, the failure to strictly comply with the Protocol, with good clinical practices, with Service timelines, with SPONSOR's written recommendations and instructions relative to the conduct of the Project, its employees or with any applicable law, regulations or authority’s requirements, its agents.
1. The indemnity given by HEMISPHERX shall be subject to the restrictions set forth in articles 9.2 and 9.3 below.
9.2 The above obligation following conditions: · No indemnity shall be claimed unless notice is given by SCIEN claiming the indemnity to HEMISPHERX together with details of CRO shall not apply nor shall CRO be liable for any indemnification or expenses, and in fact, SPONSOR shall defend, indemnify, and hold harmless CRO, for actions or claims in any way arising from or caused the claim promptly on notice of such claim being received by the wilful misconduct SCIEN; · No admissions of liability or gross negligence compromise or offer of SPONSOR or arising from or caused by any of its failures to comply with this Agreement.
9.3 The obligation of the indemnifying party hereunder, in connection with a third party claim or suit, shall apply only if the other party provides prompt written notification upon receipt of notice settlement of any claim or suit (provided, however, that neither party shall be released from its obligations under this Section 9 if the failure to promptly notify the other party does not materially prejudice the defence of any claim), permits the indemnifying party and its attorneys and personnel to handle and control the defence of such claims or suits, including pre-trial, trial or settlement, and the indemnified party fully cooperates and assists in such defence. The indemnified party further agrees that it will not settle or compromise any such claim or suit made by SCIEN without the prior written consent of HEMISPHERX; and · HEMISPHERX shall have full control over any claim, proceedings or settlement negotiations in respect of which it is providing the indemnifying partyindemnity. Subject to clause X.B 1.
9.4 The parties shall secure and maintain in full force and effect through the performance of the Project (and following termination of the applicable Study to cover any claims arising from the applicable Study) insurance coverage in amounts appropriate to the conduct of the Project and the Services contemplated by the applicable Project, and shall provide evidence of insurance coverage in an acceptable form upon request.
9.5 In the event any breach or default by any of the Party of this Agreement with respect to its obligations under this Agreement, the respective Party’s damage liability to the other Party for such breach or default shall be limited to emerging damages (i.e. “danno emergente” under Italian law), except in case SCIEN shall defend and indemnify HEMISPHERX and its Affiliates and hold each of losses sought them harmless against all claims, demands, actions, losses, expenses, damages, liabilities, costs (including interest, penalties and reasonable attorneys' fees) and judgements suffered by each of them, which arise out of SCIEN’s negligent or awarded for death wilful acts or bodily injury for omissions or which such limitation shall not apply.
9.6 CRO represents and warrants that this Agreement will be performed in material compliance with all applicable laws and regulations, including without limitation, laws and regulations relating to health, safety and environment, fair labour practices, unlawful discrimination.
9.7 CRO shall maintain/extend/renew, for the entire duration otherwise arise out of this Agreement, the approval by the French Ministry of Higher Education and Research mentioned in the premises of this agreement (the “French Ministry Approval”). Without limitation of the foregoing, CRO shall make all filings and take all actions needed in order to maintain/extend/renew the French Ministry Approval and use its best effort thereto. In case the French Ministry Approval is not maintained/extended/renewed for the entire duration SCIEN’s breach of the Agreement, due to responsibility directly and objectively attributable to CRO, CRO shall pay to SPONSOR – also by way of set off with any amount due by SPONSOR to CRO under this agreement - as forfeiture (“penale” under Italian law), per each year in which the French Ministry Approval is not maintained/extended/renewed, 30% of the Services Fees invoiced in the reference year. The above is provided that, in case the French Ministry Approval is not maintained/extended/renewed due to changes in the applicable legislation that prevent CRO to obtain it, the above provided forfeiture shall not apply.
Appears in 1 contract
Samples: Sales, Marketing, Distribution, and Supply Agreement (Hemispherx Biopharma Inc)
Indemnification and Warranties. 9.1 CRO (a) COMPANY shall defendindemnify, indemnify defend and hold harmless SPONSOR, GENERAL and its affiliated entities, and their respective trustees, officers, medical and professional staff, employees, and agents and employees from their respective successors, heirs and assigns (the “Indemnitees”), against any liability, damage, loss or expense (including reasonable attorney’s fees and all lossesexpenses of litigation) (collectively, costs, expenses, liabilities, “Losses”) incurred by or imposed upon the Indemnitees or any one of them in connection with any claims, suits, actions, demands or judgments arising out of any theory of product liability (including, but not limited to, actions and damages, directly and objectively attributable to the responsibility of CRO in the conduction form of the Project and/or performance of the Services including without limitationstort, the failure to strictly comply with the Protocol, with good clinical practices, with Service timelines, with SPONSOR's written recommendations and instructions relative to the conduct of the Projectwarranty, or with strict liability) concerning any applicable lawPRODUCT made, regulations used or authority’s requirements, subject sold pursuant to the restrictions set forth in articles 9.2 and 9.3 below.
9.2 The above obligation of CRO shall not apply nor shall CRO be liable for any indemnification right or expenses, and in fact, SPONSOR shall defend, indemnify, and hold harmless CRO, for actions or claims in any way arising from or caused by the wilful misconduct or gross negligence of SPONSOR or arising from or caused by any of its failures to comply with license granted under this Agreement.
9.3 The obligation (b) COMPANY’s indemnification under (a) above shall not apply to any Loss to the extent that it is attributable to the negligent activities, reckless misconduct or intentional misconduct of the indemnifying party hereunder, in connection with a third party claim or suit, Indemnitees.
(c) GENERAL shall apply only if the other party provides give COMPANY prompt written notification upon receipt of notice of any claim Losses or suit (discovery of fact upon which GENERAL intends to base a request for indemnification by an Indemnitee under paragraph 8.1(a), provided, however, that neither party COMPANY’s obligations to GENERAL under this Article 8 shall not be released from its obligations rendered inapplicable as a result of the failure by any Indemnitee to notify the Indemnitor as required under this Section 9 if the failure to promptly notify the other party does not materially prejudice the defence of any claim8.1(c), permits unless such failure materially adversely affects the indemnifying party and its attorneys and personnel Indemnitor’s ability to handle and control the defence of such claims or suits, including pre-trial, trial or settlement, and the indemnified party fully cooperates and assists in such defence. The indemnified party further agrees that it will not settle or compromise any such claim or suit without the prior written consent of the indemnifying party.
9.4 The parties shall secure and maintain in full force and effect through the performance of the Project (and following termination of the applicable Study to cover any claims arising from the applicable Study) insurance coverage in amounts appropriate to the conduct of the Project and the Services contemplated by the applicable Project, and shall provide evidence of insurance coverage in an acceptable form upon request.
9.5 In the event any breach or default by any of the Party of this Agreement take action with respect to any such Loss.
(d) COMPANY agrees, at its obligations under this Agreementown expense, to provide attorneys reasonably acceptable to GENERAL to defend against any actions brought or filed against any party indemnified hereunder with respect to the subject of indemnity contained herein, whether or not such actions are rightfully brought. GENERAL shall be entitled to participate in, but not control, the respective Partydefense of such action and to employ counsel of its own choice for such purpose; provided, however, that such employment shall be at GENERAL’s damage liability own expense.
(e) COMPANY shall have the sole right to consent to the other Party for entry of any judgment, enter into any settlement or otherwise dispose of any Loss, on such breach or default terms as COMPANY, in its sole discretion, shall be limited to emerging damages (i.e. “danno emergente” under Italian law), except in case of losses sought or awarded for death or bodily injury for which such limitation shall not applydeem appropriate.
9.6 CRO represents and warrants that this Agreement will be performed in material compliance with all applicable laws and regulations, including without limitation, laws and regulations relating to health, safety and environment, fair labour practices, unlawful discrimination.
9.7 CRO (f) This paragraph 8.1 shall maintain/extend/renew, for the entire duration survive expiration or termination of this Agreement, the approval by the French Ministry of Higher Education and Research mentioned in the premises of this agreement .
(the “French Ministry Approval”). Without limitation of the foregoing, CRO shall make all filings and take all actions needed in order to maintain/extend/renew the French Ministry Approval and use its best effort thereto. In case the French Ministry Approval a) Beginning at such time as any PRODUCT is not maintained/extended/renewed being commercially distributed or sold (other than for the entire duration purpose of the Agreementobtaining regulatory approvals) by COMPANY or by a licensee, due to responsibility directly affiliate or agent of COMPANY, COMPANY shall, at its sole cost and objectively attributable to CROexpense, CRO shall pay to SPONSOR – also by way of set off with any amount due by SPONSOR to CRO under this agreement - as forfeiture (“penale” under Italian law), per each year procure and maintain commercial general liability insurance in which the French Ministry Approval is amounts not maintained/extended/renewed, 30% of the Services Fees invoiced in the reference year. The above is provided that, in case the French Ministry Approval is not maintained/extended/renewed due to changes in the applicable legislation that prevent CRO to obtain it, the above provided forfeiture shall not apply.less than [...***...
Appears in 1 contract
Indemnification and Warranties. 9.1 CRO A. INDEMNIFICATION SCIEN and HEMISPHERX (each an "Indemnifying Party") shall defendindemnify, indemnify defend and hold harmless SPONSORand the other Party's subsidiaries or affiliates, its affiliated entitiestheir agents, and their respective trusteesdirectors, officers, agents employees and employees assigns (the "Indemnified Parties") from any and against all losses, costs, expenses, liabilities, claims, actions and damages, directly demands and objectively attributable to the responsibility of CRO in the conduction of the Project and/or performance of the Services expenses (including without limitationsreasonable attorneys' fees and expenses) arising out of, the failure to strictly comply with the Protocol, with good clinical practices, with Service timelines, with SPONSOR's written recommendations and instructions relative to the conduct of the Projectas a result of, or with any applicable law, regulations or authority’s requirements, subject to the restrictions set forth in articles 9.2 and 9.3 below.
9.2 The above obligation of CRO shall not apply nor shall CRO be liable for any indemnification or expenses, and in fact, SPONSOR shall defend, indemnify, and hold harmless CRO, for actions or claims in any way arising from or caused by the wilful misconduct or gross negligence of SPONSOR or arising from or caused by any of its failures to comply with this Agreement.
9.3 The obligation of the indemnifying party hereunder, in connection with a (i) the negligent actions of the Indemnifying Party, its employees or any third party claim acting on behalf of or suit, shall apply only if under authority of the other party provides prompt written notification upon receipt Indemnifying Party in the performance of notice this Agreement and/or (ii) the violation of any claim representation or suit (provided, however, that neither party shall be released from its warranty of Indemnifying Party in this Agreement. Each Party's obligations under this Section 9 if the failure to promptly notify the other party does not materially prejudice the defence of any claim), permits the indemnifying party and its attorneys and personnel to handle and control the defence of such claims or suits, including pre-trial, trial or settlement, and the indemnified party fully cooperates and assists in such defence. The indemnified party further agrees that it will not settle or compromise any such claim or suit without the prior written consent of the indemnifying party.
9.4 The parties provision shall secure and maintain in full force and effect through the performance of the Project (and following termination of the applicable Study to cover any claims arising from the applicable Study) insurance coverage in amounts appropriate to the conduct of the Project and the Services contemplated by the applicable Project, and shall provide evidence of insurance coverage in an acceptable form upon request.
9.5 In the event any breach or default by any of the Party of this Agreement with respect to its obligations under this Agreement, the respective Party’s damage liability be subject to the other Party for providing reasonable notice of any such breach claim. Each Party shall defend with competent counsel and pay all costs of defence, including attorneys' fees, and any and all damages and court costs awarded in respect to such claim, action or default shall be limited proceeding regarding the claim of infringement. The Indemnified Parties agree to emerging damages (i.e. “danno emergente” under Italian law)permit the Indemnifying Party to defend, except in case of losses sought compromise, or awarded for death settle any such claim, action or bodily injury for which such limitation shall not apply.
9.6 CRO represents proceeding and warrants that this Agreement further agree to provide all available information, and reasonable assistance to enable the other Indemnifying Party to do so. However, neither party will be performed in material compliance with all applicable laws and regulationsliable under this indemnity for any losses, including without limitationliabilities, laws and regulations relating to healthdamages, safety and environment, fair labour practices, unlawful discrimination.
9.7 CRO shall maintain/extend/renew, for the entire duration of this Agreement, the approval by the French Ministry of Higher Education and Research mentioned in the premises of this agreement (the “French Ministry Approval”). Without limitation demands or expenses arising out of the foregoing, CRO shall make all filings and take all actions needed in order to maintain/extend/renew the French Ministry Approval and use its best effort thereto. In case the French Ministry Approval is not maintained/extended/renewed for the entire duration gross negligence or wilful misconduct of the Agreementother party or any of its affiliates, due to responsibility directly and objectively attributable to CROagents, CRO shall pay to SPONSOR – also by way directors, officers, employees or assigns. Limitation of set off with any amount due by SPONSOR to CRO under this agreement - as forfeiture (“penale” under Italian law)Liability. IN NO EVENT WILL EITHER PARTY BE LIABLE FOR ANY INCIDENTAL, per each year in which the French Ministry Approval is not maintained/extended/renewed, 30% of the Services Fees invoiced in the reference year. The above is provided that, in case the French Ministry Approval is not maintained/extended/renewed due to changes in the applicable legislation that prevent CRO to obtain it, the above provided forfeiture shall not applySPECIAL OR CONSEQUENTIAL DAMAGES RESULTING FROM THE LICENSE GRANTED PURSUANT TO THIS AGREEMENT OR THE USE OR COMMERCIAL DEVELOPMENT OF PRODUCT.
Appears in 1 contract
Samples: Sales, Marketing, Distribution, and Supply Agreement (Hemispherx Biopharma Inc)
Indemnification and Warranties. 9.1 CRO A. INDEMNIFICATION EMERGE and HEMISPHERX (each an "Indemnifying Party") shall defendindemnify, indemnify defend and hold harmless SPONSORand the other Party's subsidiaries or affiliates, its affiliated entitiestheir agents, and their respective trusteesdirectors, officers, agents employees and employees assigns (the "Indemnified Parties") from any and against all losses, costs, expenses, liabilities, claims, actions and damages, directly demands and objectively attributable to the responsibility of CRO in the conduction of the Project and/or performance of the Services expenses (including without limitationsreasonable attorneys' fees and expenses) arising out of, the failure to strictly comply with the Protocol, with good clinical practices, with Service timelines, with SPONSOR's written recommendations and instructions relative to the conduct of the Projectas a result of, or with any applicable law, regulations or authority’s requirements, subject to the restrictions set forth in articles 9.2 and 9.3 below.
9.2 The above obligation of CRO shall not apply nor shall CRO be liable for any indemnification or expenses, and in fact, SPONSOR shall defend, indemnify, and hold harmless CRO, for actions or claims in any way arising from or caused by the wilful misconduct or gross negligence of SPONSOR or arising from or caused by any of its failures to comply with this Agreement.
9.3 The obligation of the indemnifying party hereunder, in connection with a (i) the negligent actions of the Indemnifying Party, its employees or any third party claim acting on behalf of or suit, shall apply only if under authority of the other party provides prompt written notification upon receipt Indemnifying Party in the performance of notice this Agreement and/or (ii) the violation of any claim representation or suit (provided, however, that neither party shall be released from its warranty of Indemnifying Party in this Agreement. Each Party's obligations under this Section 9 if the failure to promptly notify the other party does not materially prejudice the defence of any claim), permits the indemnifying party and its attorneys and personnel to handle and control the defence of such claims or suits, including pre-trial, trial or settlement, and the indemnified party fully cooperates and assists in such defence. The indemnified party further agrees that it will not settle or compromise any such claim or suit without the prior written consent of the indemnifying party.
9.4 The parties provision shall secure and maintain in full force and effect through the performance of the Project (and following termination of the applicable Study to cover any claims arising from the applicable Study) insurance coverage in amounts appropriate to the conduct of the Project and the Services contemplated by the applicable Project, and shall provide evidence of insurance coverage in an acceptable form upon request.
9.5 In the event any breach or default by any of the Party of this Agreement with respect to its obligations under this Agreement, the respective Party’s damage liability be subject to the other Party for providing reasonable notice of any such breach claim. Each Party shall defend with competent counsel and pay all costs of defence, including attorneys' fees, and any and all damages and court costs awarded in respect to such claim, action or default shall be limited proceeding regarding the claim of infringement. The Indemnified Parties agree to emerging damages (i.e. “danno emergente” under Italian law)permit the Indemnifying Party to defend, except in case of losses sought compromise, or awarded for death settle any such claim, action or bodily injury for which such limitation shall not apply.
9.6 CRO represents proceeding and warrants that this Agreement further agree to provide all available information, and reasonable assistance to enable the other Indemnifying Party to do so. However, neither party will be performed in material compliance with all applicable laws and regulationsliable under this indemnity for any losses, including without limitationliabilities, laws and regulations relating to healthdamages, safety and environment, fair labour practices, unlawful discrimination.
9.7 CRO shall maintain/extend/renew, for the entire duration of this Agreement, the approval by the French Ministry of Higher Education and Research mentioned in the premises of this agreement (the “French Ministry Approval”). Without limitation demands or expenses arising out of the foregoing, CRO shall make all filings and take all actions needed in order to maintain/extend/renew the French Ministry Approval and use its best effort thereto. In case the French Ministry Approval is not maintained/extended/renewed for the entire duration gross negligence or wilful misconduct of the Agreementother party or any of its affiliates, due to responsibility directly and objectively attributable to CROagents, CRO shall pay to SPONSOR – also by way directors, officers, employees or assigns. Limitation of set off with any amount due by SPONSOR to CRO under this agreement - as forfeiture (“penale” under Italian law)Liability. IN NO EVENT WILL EITHER PARTY BE LIABLE FOR ANY INCIDENTAL, per each year in which the French Ministry Approval is not maintained/extended/renewed, 30% of the Services Fees invoiced in the reference year. The above is provided that, in case the French Ministry Approval is not maintained/extended/renewed due to changes in the applicable legislation that prevent CRO to obtain it, the above provided forfeiture shall not applySPECIAL OR CONSEQUENTIAL DAMAGES RESULTING FROM THE LICENSE GRANTED PURSUANT TO THIS AGREEMENT OR THE USE OR COMMERCIAL DEVELOPMENT OF AMPLIGEN.
Appears in 1 contract
Samples: Sales, Marketing, Distribution, and Supply Agreement (Hemispherx Biopharma Inc)