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Contract analysis / exhibit-d-subject-injury-indemnification.docx
exhibit-d-subject-injury-indemnification.docx
High · 12
Medium · 0
Standard · 0
Section 1: Definitions
High
⚑ Penalty / liquidated damages
Section 1: Definitions For purposes of this Exhibit D, the following terms shall have the meanings set forth below: 1.1 "Claim" shall mean any demand, action, suit, proceeding (whether at law, in equity, or before any administrative or regulatory body), investigation, or claim by a third party (including, without limitation, a Study Subject, any estate or personal representative of a Study Subject, any family member
Section 2: Sponsor Indemnification of Site Indemnified Parties
High
⚑ Non-compete / exclusivity restraint
Section 2: Sponsor Indemnification of Site Indemnified Parties 2.1 General Indemnification Obligation. Subject to the terms, conditions, and exclusions set forth in this Exhibit D, Penterra shall defend, indemnify, and hold harmless each Site Indemnified Party from and against all Indemnified Losses arising from or relating to any of the following: (a) Any Study-Related Injury caused by the Investigational Product (P
Section 3: Carve-Outs and Exclusions from Sponsor Indemnification
High
⚑ Indemnity / guarantee obligation
Section 3: Carve-Outs and Exclusions from Sponsor Indemnification 3.1 Exclusions. Notwithstanding anything to the contrary in Section 2, Sponsor's indemnification obligation under Section 2 shall NOT apply to Indemnified Losses to the extent that such Indemnified Losses arise from or are attributable to any of the following: (i) The negligence, recklessness, or willful misconduct of the Participating Site, any Invest
Section 4: Study Subject Medical Care Costs
High
⚑ Non-compete / exclusivity restraint
Section 4: Study Subject Medical Care Costs 4.1 Obligation to Cover Medical Costs. In addition to and without limiting the indemnification obligations set forth in Section 2, Penterra shall bear the reasonable and customary medical costs for the diagnosis and treatment of Study-Related Injuries sustained by Study Subjects in connection with the CLARION trial, to the extent such costs satisfy each of the following con
Section 5: Reciprocal Indemnification by Veridian and Participating Sites
High
⚑ Indemnity / guarantee obligation
Section 5: Reciprocal Indemnification by Veridian and Participating Sites 5.1 Site Network Indemnification Obligation. Subject to the terms, conditions, exclusions, and caps set forth in this Exhibit D, Veridian and each Participating Site (jointly and severally, as among Veridian and the applicable Participating Site at which the relevant acts or omissions occurred, but not jointly and severally as among all Partici
Section 6: Notice Requirements
High
⚑ Indemnity / guarantee obligation
Section 6: Notice Requirements 6.1 Obligation to Provide Notice. Any Indemnified Party (whether a Site Indemnified Party or a Sponsor Indemnified Party) seeking indemnification or coverage of medical costs under this Exhibit D shall provide prompt written notice (a "Notice of Claim") to the Indemnifying Party within thirty (30) calendar days after such Indemnified Party first becomes aware of a Claim or of facts and
Section 7: Defense and Settlement Procedures
High
⚑ Indemnity / guarantee obligation
Section 7: Defense and Settlement Procedures 7.1 Right to Assume Defense. Upon receipt of a Notice of Claim under Section 6, the Indemnifying Party shall have the right (but not the obligation) to assume the defense of such Claim, at its own expense and through counsel of its own choosing, by providing written notice to the Indemnified Party within twenty (20) business days of receipt of the Notice of Claim. The Inde
Section 8: Insurance
High
⚑ Indemnity / guarantee obligation
Section 8: Insurance 8.1 Sponsor Insurance Requirements. Penterra shall procure and maintain, at its own expense, clinical trial liability insurance (including products liability and completed operations coverage applicable to the CLARION trial) throughout the term of the Agreement and for a period of not less than three (3) years following the completion, expiration, or termination of the CLARION trial (including an
Section 9: Subrogation and Recovery
High
⚑ Indemnity / guarantee obligation
Section 9: Subrogation and Recovery 9.1 Subrogation Rights. To the extent that the Indemnifying Party pays or is obligated to pay Indemnified Losses to or on behalf of an Indemnified Party under this Exhibit D, the Indemnifying Party shall be subrogated to all rights, claims, causes of action, and remedies of the Indemnified Party against any third party (including, without limitation, manufacturers, suppliers, contr
Section 10: Dispute Resolution
High
⚑ Non-compete / exclusivity restraint
Section 10: Dispute Resolution 10.1 Incorporation by Reference. Any dispute, controversy, or claim arising under, out of, or relating to the indemnification provisions of this Exhibit D, or the breach, validity, or interpretation thereof (each, a "Dispute"), shall be resolved in accordance with the dispute resolution procedures set forth in Article XIV of the Agreement, as summarized below and as more fully set forth
Section 11: Regulatory Reporting and Safety Coordination
High
⚑ Indemnity / guarantee obligation
Section 11: Regulatory Reporting and Safety Coordination 11.1 SAE Reporting. Nothing in this Exhibit D shall be construed to affect, delay, modify, or relieve the obligation of each Participating Site and each Investigator to report serious adverse events ("SAEs") in accordance with the timelines and procedures set forth in the Protocol, the Agreement, and Exhibit J to the Agreement (Safety Reporting Plan). Without l
Section 12: Term and Survival
High
⚑ Unilateral / for-convenience termination
Section 12: Term and Survival 12.1 Effective Period. The indemnification obligations, medical care cost obligations, and all other rights and obligations set forth in this Exhibit D shall become effective on the Effective Date of the Agreement (June 28, 2023) and shall remain in full force and effect throughout the term of the Agreement and for the survival periods specified in this Section 12. The indemnification ob