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Contract analysis / exhibit-e-insurance-requirements.docx
exhibit-e-insurance-requirements.docx
1018-00004 · 30 clauses
High · 5 Medium · 5 Standard · 1
ARTICLE I — SPONSOR INSURANCE REQUIREMENTS
ARTICLE I — SPONSOR INSURANCE REQUIREMENTS
Section 1.1 — Clinical Trial Liability Insurance
Section 1.1 — Clinical Trial Liability Insurance Penterra Pharmaceuticals Corp. shall procure and maintain, at its sole cost and expense, clinical trial liability insurance covering bodily injury, personal injury, and subject injury arising from or related to the conduct of Protocol PPC-4871-III at all participating Veridian Network sites. Such coverage shall extend to all aspects of the CLARION trial, including, wit
Section 1.2 — Minimum Coverage Limits High
⚑ Indemnity / guarantee obligation
Section 1.2 — Minimum Coverage Limits The clinical trial liability insurance maintained by Sponsor pursuant to Section 1.1 shall provide, at a minimum, the following coverage limits: (a) Per-Occurrence Limit: Twenty-Five Million Dollars ($25,000,000) per occurrence for claims arising from or related to the conduct of Protocol PPC-4871-III. (b) Annual Aggregate Limit: Seventy-Five Million Dollars ($75,000,000) in the
Section 1.3 — Additional Insured Endorsement
Section 1.3 — Additional Insured Endorsement Sponsor's clinical trial liability insurance policy maintained pursuant to this Article I shall be endorsed to name the following entities and individuals as additional insureds under the policy: (a) Veridian Health Research Network, Inc., the Site Network entity, including its officers, directors, trustees, employees, and agents acting within the scope of their duties in
Section 1.4 — Sponsor's Ongoing Obligations Medium
⚑ Notice / time limit to track
Section 1.4 — Sponsor's Ongoing Obligations Sponsor shall maintain the clinical trial liability insurance required under this Article I continuously, without lapse, gap, or interruption in coverage, during the entire term of the Agreement and for a period of three (3) years following the later of: (a) the projected study completion date, which is currently estimated as August 2028, subject to adjustment based on actu
ARTICLE II — SITE NETWORK AND SITE INSTITUTION INSURANCE REQUIREMENTS
ARTICLE II — SITE NETWORK AND SITE INSTITUTION INSURANCE REQUIREMENTS
Section 2.1 — General Liability and Professional Liability Insurance Medium
⚑ Forum / governing law
Section 2.1 — General Liability and Professional Liability Insurance Veridian Health Research Network, Inc. shall ensure that it and each participating Veridian Network site institution maintain, at their respective cost and expense, the following insurance coverage throughout the entire term of the Agreement, including any extension or renewal thereof, and for such additional periods as may be required by applicable
Section 2.2 — Workers' Compensation and Employer's Liability
Section 2.2 — Workers' Compensation and Employer's Liability Each participating Veridian Network site institution shall maintain workers' compensation insurance in full compliance with the statutory requirements of the state or states in which such site institution operates, including all applicable statutory benefits and coverage mandated by state law. No site institution may opt out of, or seek exemption from, stat
Section 2.3 — Self-Insurance Programs
Section 2.3 — Self-Insurance Programs To the extent that any Veridian Network site institution is self-insured, or participates in a self-insurance trust, risk-retention group, governmental self-insurance pool, captive insurance arrangement, or similar alternative risk transfer mechanism, such self-insurance program shall satisfy the requirements of this Article II, provided that all of the following conditions are m
Section 2.4 — Site Network's Ongoing Obligations Medium
⚑ Notice / time limit to track
Section 2.4 — Site Network's Ongoing Obligations Veridian Health Research Network, Inc. shall provide to Sponsor at least thirty (30) days' prior written notice of any cancellation, non-renewal, or material reduction in coverage limits or scope applicable to any participating Veridian Network site institution's insurance coverage. Veridian shall exercise commercially reasonable efforts to monitor the insurance compli
ARTICLE III — CERTIFICATE EXCHANGE REQUIREMENTS
ARTICLE III — CERTIFICATE EXCHANGE REQUIREMENTS
Section 3.1 — Initial Exchange of Certificates
Section 3.1 — Initial Exchange of Certificates Each party shall deliver to the other party certificates of insurance evidencing all required coverage under this Exhibit E within fifteen (15) business days of the execution date of the Agreement. Based on the execution date of June 28, 2023, the deadline for initial delivery of all certificates of insurance is no later than July 19, 2023. Sponsor's Certificate. Sponsor
Section 3.2 — Annual Renewal Certificates
Section 3.2 — Annual Renewal Certificates Each party shall deliver updated certificates of insurance to the other party annually, no later than fifteen (15) business days following each applicable policy renewal date. Updated certificates shall reflect any changes in carrier, policy number, coverage limits, deductibles, endorsements, or other material terms since the prior certificate was issued. For Sponsor, the ann
Section 3.3 — Delivery Instructions
Section 3.3 — Delivery Instructions Certificates to Sponsor. All certificates of insurance, endorsements, and related insurance documentation required to be delivered to Sponsor under this Exhibit E shall be sent to the following addresses: Penterra Pharmaceuticals Corp. Attn: Samantha Novak, Director, Clinical Contracts 200 Biopharma Boulevard, Suite 1400 Princeton, NJ 08540 With a copy to: Rebecca Liang, Esq. Assoc
Section 3.4 — Conditions Precedent
Section 3.4 — Conditions Precedent Delivery of all required certificates of insurance by both parties constitutes a condition precedent to closing under the Agreement, as referenced in the Conditions Precedent Satisfaction Memorandum dated July 5, 2023. The parties acknowledge that the satisfaction of insurance certificate delivery requirements was confirmed in such memorandum and that the Agreement became fully effe
ARTICLE IV — GENERAL INSURANCE PROVISIONS
ARTICLE IV — GENERAL INSURANCE PROVISIONS
Section 4.1 — Waiver of Subrogation Standard
⚑ Commercial term
Section 4.1 — Waiver of Subrogation Each party shall use commercially reasonable efforts to cause its insurer or insurers to include in the applicable insurance policies a waiver of subrogation in favor of the other party and its respective affiliates, subsidiaries, officers, directors, trustees, employees, agents, investigators, and site staff with respect to claims arising from or related to the conduct of Protocol
Section 4.2 — Deductibles and Retentions High
⚑ Indemnity / guarantee obligation
Section 4.2 — Deductibles and Retentions Any deductibles, self-insured retentions, or similar risk-retention mechanisms under a party's insurance policies shall be the sole responsibility of such party. Neither party shall assert any right to recover from the other party the amount of any deductible or self-insured retention applicable to a claim under its own insurance policy, unless such right is expressly establis
Section 4.3 — No Limitation on Indemnification Obligations High
⚑ Indemnity / guarantee obligation
Section 4.3 — No Limitation on Indemnification Obligations The insurance requirements set forth in this Exhibit E are in addition to, and do not limit, reduce, or supersede, either party's indemnification obligations under the Agreement, including, without limitation, the indemnification obligations set forth in Exhibit D (Subject-Injury Indemnification Provisions). The procurement and maintenance of insurance by eit
Section 4.4 — Right to Audit Medium
⚑ Confidentiality undertaking
Section 4.4 — Right to Audit Upon reasonable request and upon no less than fifteen (15) business days' prior written notice, either party may request to review the other party's insurance policies, endorsements, or relevant excerpts thereof to verify compliance with the requirements of this Exhibit E. Such requests shall be made no more than once per calendar year, unless a party has a reasonable, good-faith basis to
Section 4.5 — Coordination with Exhibit D High
⚑ Indemnity / guarantee obligation
Section 4.5 — Coordination with Exhibit D The subject-injury sublimit under Sponsor's clinical trial liability policy (Ten Million Dollars ($10,000,000) per occurrence and Fifty Million Dollars ($50,000,000) in the aggregate) is intended to provide insurance coverage for Sponsor's obligations under Exhibit D (Subject-Injury Indemnification Provisions) with respect to the payment of medical costs for the treatment of
ARTICLE V — REMEDIES FOR NON-COMPLIANCE
ARTICLE V — REMEDIES FOR NON-COMPLIANCE
Section 5.1 — Notice and Cure
Section 5.1 — Notice and Cure If either party fails to maintain the insurance coverage required under this Exhibit E, or fails to deliver certificates of insurance, endorsements, or other documentation required hereunder within the specified timeframes, the non-breaching party shall provide written notice to the breaching party specifying the nature and extent of the deficiency. Such notice shall identify the specifi
Section 5.2 — Suspension and Termination Rights High
⚑ Non-compete / exclusivity restraint
Section 5.2 — Suspension and Termination Rights If the deficiency identified in the notice provided under Section 5.1 is not cured within the fifteen (15) business day cure period, the non-breaching party shall have the following rights and remedies, which shall be in addition to any other rights and remedies available under the Agreement or at law or in equity: (a) Remedies Available to Site Network. If Sponsor fail
1. Veridian Health Research Network, Inc. (EIN: 23-4178205), 750 Research Parkway, 8th Fl
1. Veridian Health Research Network, Inc. (EIN: 23-4178205), 750 Research Parkway, 8th Floor, Philadelphia, PA 19104, including its officers, directors, trustees, employees, and agents acting within the scope of their duties in connection with Protocol PPC-4871-III.
2. Each site institution listed in the attached Schedule 1 to the MCTA, consisting of thi
2. Each site institution listed in the attached Schedule 1 to the MCTA, consisting of thirty-eight (38) participating clinical trial sites located across fourteen (14) states, including, without limitation: (a) Graystone University Medical Center (Site 001), 1200 University Avenue, Philadelphia, PA 19104; and (b) Lakemont Medical Center (Site 002), 4400 North Michigan Drive, Chicago, IL 60611.
3. Each investigator and site staff member acting within the scope of Protocol PPC-4871-I
3. Each investigator and site staff member acting within the scope of Protocol PPC-4871-III at any participating site, including, without limitation: (a) Dr. Catherine Aldridge, M.D., Ph.D., Global Principal Investigator; and (b) Dr. Howard Matsuoka, M.D., Co-Principal Investigator. The additional insured coverage is required to be primary and non-contributory with respect to any insurance maintained by or on behalf
1. Veridian Health Research Network, Inc., 750 Research Parkway, 8th Floor, Philadelphia,
1. Veridian Health Research Network, Inc., 750 Research Parkway, 8th Floor, Philadelphia, PA 19104, including its officers, directors, trustees, employees, and agents acting within the scope of their duties in connection with Protocol PPC-4871-III.
2. Each participating site institution identified in Schedule 1 to the Master Clinical Tr
2. Each participating site institution identified in Schedule 1 to the Master Clinical Trial Agreement dated June 28, 2023, by and between the Named Insured and Veridian Health Research Network, Inc., including each such site institution's officers, directors, trustees, employees, and agents acting within the scope of Protocol PPC-4871-III. The list of participating site institutions may be updated from time to time
3. Each investigator, sub-investigator, study coordinator, research nurse, pharmacist, an Medium
⚑ Liability cap to check against exposure
3. Each investigator, sub-investigator, study coordinator, research nurse, pharmacist, and other site staff member at any participating site who is acting within the scope of Protocol PPC-4871-III, including, without limitation, Dr. Catherine Aldridge, M.D., Ph.D. (Global Principal Investigator) and Dr. Howard Matsuoka, M.D. (Co-Principal Investigator). PRIMARY AND NON-CONTRIBUTORY. The coverage afforded to the addit