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EXHIBIT E

INSURANCE REQUIREMENTS AND CERTIFICATE FORMS

Attached to and forming part of the Master Clinical Trial Agreement dated June 28, 2023 (the "Agreement"), by and between Penterra Pharmaceuticals Corp., a Delaware corporation ("Sponsor"), and Veridian Health Research Network, Inc., a Delaware 501(c)(3) corporation ("Site Network").

Protocol: Protocol PPC-4871-III ("CLARION" — Clinical Assessment of Response with Longitudinal Investigation in ONcology)

Investigational Product: Penterafenib (PPC-4871)

Capitalized terms used but not otherwise defined in this Exhibit E shall have the meanings ascribed to them in the Agreement.

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ARTICLE I — SPONSOR INSURANCE REQUIREMENTS

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, without limitation, the manufacture, supply, distribution, storage, handling, and administration of the investigational product penterafenib (PPC-4871), as well as the collection and processing of biological samples, the performance of protocol-specified procedures, and the monitoring and oversight activities conducted by or on behalf of Sponsor at each participating site.

The clinical trial liability insurance required under this Section 1.1 shall be procured from and maintained with an insurance carrier rated A- (Excellent) or better by A.M. Best Company, Inc., and such carrier shall be authorized to do business and to write clinical trial liability or comparable coverage in each state in which a participating Veridian Network site is located. Sponsor shall ensure that the carrier's financial size category, as determined by A.M. Best, is no less than Category VIII at all times during the term of the required coverage.

As of the Effective Date of the Agreement, Sponsor's clinical trial liability insurance is provided by the following carrier:

Carrier: Briarcliff Mutual Insurance Company, a mutual insurance company organized under the laws of the State of Connecticut, with principal offices located at 55 Constitution Plaza, Hartford, CT 06103.

Policy Number: BM-CTL-2023-04182

Policy Period: April 1, 2023 through March 31, 2024, renewable annually thereafter.

The Briarcliff Mutual Insurance Company policy shall be renewed annually throughout the entire term of the Agreement and shall be maintained for a minimum of three (3) years following the completion of the last subject's participation in the study, including any follow-up visits, survival monitoring periods, or post-treatment safety assessments required by the Protocol, by any applicable regulatory authority, or by the Agreement. For purposes of this Section 1.1, "completion of the last subject's participation" shall mean the date on which all protocol-required activities, including long-term follow-up, have been completed or formally discontinued for the final enrolled subject across all participating sites.

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 annual aggregate for all claims arising from or related to the conduct of Protocol PPC-4871-III during each policy period.

(c) Subject-Injury Sublimit: Ten Million Dollars ($10,000,000) per occurrence and Fifty Million Dollars ($50,000,000) in the aggregate for claims specifically arising from study-related injuries to trial subjects, as further described below.

The clinical trial liability coverage shall be written on an occurrence basis. In the event that occurrence-basis coverage is unavailable or is replaced by a claims-made policy at any point during the term of coverage, any such claims-made policy shall include a retroactive date no later than the date of first subject enrollment under Protocol PPC-4871-III at any Veridian Network site, and shall provide an extended reporting period (commonly referred to as "tail coverage") of no less than three (3) years following the expiration, cancellation, or non-renewal of such claims-made policy. The cost of any extended reporting period endorsement shall be borne solely by Sponsor.

The subject-injury sublimit described in clause (c) above shall apply specifically to claims for medical costs, hospitalization expenses, rehabilitation costs, and other reasonable and necessary medical expenses arising from study-related injuries to trial subjects when the investigational product penterafenib (PPC-4871) is administered in accordance with the Protocol, and when such injuries are not attributable to the negligence or willful misconduct of Site Network, the site institution, or site personnel. The subject-injury sublimit is intended to correspond to and support Sponsor's obligations under Exhibit D (Subject-Injury Indemnification Provisions) of the Agreement, and the scope and application of this sublimit shall be interpreted consistently with the provisions of Exhibit D. For the avoidance of doubt, the subject-injury sublimit operates within, and does not increase, the per-occurrence and annual aggregate limits set forth in clauses (a) and (b) above.

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 connection with Protocol PPC-4871-III;

(b) Each participating Veridian Network site institution identified in Schedule 1 to the Agreement, including, without limitation:

(i) Graystone University Medical Center (Site 001), located at 1200 University Avenue, Philadelphia, PA 19104;

(ii) Lakemont Medical Center (Site 002), located at 4400 North Michigan Drive, Chicago, IL 60611; and

(iii) Each additional site institution added to Schedule 1 during the term of the Agreement in accordance with the procedures set forth therein;

(c) Each principal investigator, co-principal investigator, sub-investigator, study coordinator, research nurse, pharmacist, and other site staff member acting within the scope of Protocol PPC-4871-III at any participating site, including, specifically:

(i) Dr. Catherine Aldridge, M.D., Ph.D., serving as Global Principal Investigator for Protocol PPC-4871-III; and

(ii) Dr. Howard Matsuoka, M.D., serving as Co-Principal Investigator for Protocol PPC-4871-III.

The additional insured status granted under this Section 1.3 shall apply solely to claims arising out of or related to the conduct of Protocol PPC-4871-III and the use, administration, handling, storage, or distribution of the investigational product penterafenib (PPC-4871). Such additional insured status shall not extend to any claims arising from activities unrelated to the CLARION trial, including, without limitation, standard-of-care clinical activities, other sponsored research, or the site institution's general operations.

The additional insured endorsement shall specify that the coverage afforded to additional insureds is primary and non-contributory with respect to Site Network's and each site institution's own insurance policies, self-insurance programs, or other coverage arrangements. In the event of a covered claim, Sponsor's clinical trial liability policy shall respond first and shall not seek contribution from any insurance maintained by or on behalf of any additional insured, except to the extent that such claim arises from the sole negligence, willful misconduct, or independent breach of the Agreement by the additional insured. The additional insured endorsement shall contain no provision requiring exhaustion of any other insurance available to the additional insureds as a condition of coverage under the Briarcliff policy.

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 actual enrollment timelines and protocol amendments; or

(b) the date of the final enrolled subject's last study visit, including any extended follow-up period required by the Protocol, any applicable regulatory authority (including, without limitation, the United States Food and Drug Administration), any data safety monitoring board recommendation, or the Agreement.

Sponsor shall provide to Site Network at least thirty (30) days' prior written notice of any cancellation, non-renewal, material reduction in coverage limits or scope, or any other material change to the clinical trial liability insurance policy that could adversely affect the coverage available to Site Network, any site institution, or any investigator or site staff member named as an additional insured. For purposes of this Section 1.4, a "material reduction" includes, without limitation, any decrease in the per-occurrence limit, aggregate limit, or subject-injury sublimit below the minimums specified in Section 1.2, any change from occurrence-basis to claims-made coverage without the extended reporting period required by Section 1.2, any removal or material limitation of the additional insured endorsement, or any increase in the deductible or self-insured retention that would materially impair the coverage available to additional insureds.

In the event that the Briarcliff Mutual Insurance Company policy (Policy No. BM-CTL-2023-04182) is replaced by a policy issued by a different carrier at any time during the required coverage period, Sponsor shall:

(a) ensure that the replacement policy provides coverage equivalent to or superior to the coverage afforded under the Briarcliff policy, including the per-occurrence limit, aggregate limit, subject-injury sublimit, additional insured endorsement (primary and non-contributory), and waiver of subrogation;

(b) provide to Site Network updated certificates of insurance and copies of the additional insured endorsement reflecting the replacement carrier and confirming equivalent or superior coverage, within fifteen (15) business days of the effective date of the replacement policy; and

(c) ensure that there is no gap or lapse in coverage between the expiration or cancellation of the Briarcliff policy and the inception of the replacement policy.

Sponsor shall designate an insurance coordinator or other responsible individual within its organization to ensure compliance with the obligations set forth in this Article I, and shall provide the name and contact information of such individual to Site Network upon execution of the Agreement and promptly upon any change in such designation.

ARTICLE II — SITE NETWORK AND SITE INSTITUTION INSURANCE REQUIREMENTS

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 law or professional standards:

(a) Commercial General Liability Insurance. Each participating site institution shall maintain commercial general liability insurance, including coverage for premises liability, operations liability, products/completed operations liability, and contractual liability, with minimum limits of:

(i) Five Million Dollars ($5,000,000) per occurrence; and

(ii) Ten Million Dollars ($10,000,000) in the annual aggregate.

(b) Professional Liability (Errors and Omissions / Medical Malpractice) Insurance. Each participating site institution shall maintain professional liability insurance, including medical malpractice coverage, covering acts, errors, and omissions of physicians, investigators, nurses, pharmacists, study coordinators, and other clinical and research personnel involved in the conduct of Protocol PPC-4871-III, with minimum limits of:

(i) Five Million Dollars ($5,000,000) per occurrence (or per claim, if written on a claims-made basis); and

(ii) Ten Million Dollars ($10,000,000) in the annual aggregate.

The foregoing minimum limits may be satisfied through a combination of primary insurance policies and umbrella or excess liability policies, provided that the umbrella or excess policies follow form to the underlying primary policies and provide coverage on terms no less favorable than the primary policies. All policies maintained under this Section 2.1 shall be issued by insurance carriers rated A- (Excellent) or better by A.M. Best Company, Inc., and authorized to do business in the applicable state or states in which the site institution operates. In the event that any professional liability policy is written on a claims-made basis, such policy shall include a retroactive date no later than the date of first subject enrollment at the applicable site, and the site institution shall maintain either continuous claims-made coverage or an extended reporting period of no less than three (3) years following the cessation of the site institution's participation in the study.

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, statutory workers' compensation requirements unless such opt-out or exemption is expressly permitted under applicable state law and does not impair the protections afforded to employees of the site institution who are involved in the conduct of Protocol PPC-4871-III.

In addition to statutory workers' compensation coverage, each participating site institution shall maintain employer's liability insurance with minimum limits of One Million Dollars ($1,000,000) per occurrence for bodily injury by accident and One Million Dollars ($1,000,000) per employee for bodily injury by disease.

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 met:

(a) The self-insurance program provides coverage and financial protection at least equivalent to the minimum limits specified in Sections 2.1 and 2.2, including both per-occurrence and aggregate limits for general liability and professional liability;

(b) Veridian provides to Sponsor, upon request and no less frequently than annually, a written certification from a qualified actuary (who is a Fellow of the Casualty Actuarial Society or holds equivalent professional credentials) or a qualified risk manager (who holds a Chartered Property Casualty Underwriter or Associate in Risk Management designation, or equivalent) confirming the adequacy, solvency, and financial soundness of the self-insurance program, including a statement that the program maintains sufficient reserves to satisfy claims at the levels required by this Exhibit E;

(c) The self-insurance program has been in continuous operation for a minimum of five (5) years as of the Effective Date of the Agreement, or, in the alternative, the site institution provides evidence of equivalent financial strength satisfactory to Sponsor in its reasonable judgment; and

(d) The self-insurance program is not subject to any pending regulatory action, insolvency proceeding, or material legal challenge that could impair its ability to pay claims arising from the conduct of Protocol PPC-4871-III.

In the event that a site institution's self-insurance program ceases to meet any of the foregoing conditions during the term of the Agreement, Veridian shall promptly notify Sponsor in writing and shall cause the affected site institution to procure commercial insurance meeting the requirements of Sections 2.1 and 2.2 within thirty (30) days of such notification. Failure to procure replacement coverage within such period shall constitute grounds for suspension of the site institution's participation in the study in accordance with Article V of this Exhibit E.

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 compliance of each participating site institution and shall include in each Individual Site Agreement a requirement that the site institution promptly notify Veridian of any change in its insurance coverage that could affect compliance with the requirements of this Article II.

If any participating site institution fails to maintain the required insurance coverage at any time during its participation in Protocol PPC-4871-III, Veridian shall promptly notify Sponsor in writing, specifying the nature of the deficiency, the identity of the affected site institution, and the steps being taken to remedy the deficiency. Upon receipt of such notification, the affected site institution's participation in the study may be suspended, in whole or in part, at Sponsor's election, until compliant insurance coverage is restored and an updated certificate of insurance evidencing such compliant coverage has been delivered to Sponsor. During any period of suspension, the affected site institution shall not enroll new subjects, but shall continue to provide necessary medical care and safety monitoring to any subjects already enrolled at such site, in accordance with the Protocol and applicable ethical and regulatory requirements.

Veridian shall maintain a centralized insurance tracking system or equivalent process to monitor the insurance status of each participating site institution and shall provide to Sponsor, upon reasonable request, a summary report of the insurance coverage maintained by each site institution participating in the CLARION trial.

ARTICLE III — CERTIFICATE EXCHANGE REQUIREMENTS

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's certificate of insurance shall be delivered by or on behalf of Briarcliff Mutual Insurance Company and shall evidence the following:

(a) Policy No. BM-CTL-2023-04182, with the policy type identified as Clinical Trial Liability;

(b) The per-occurrence limit of Twenty-Five Million Dollars ($25,000,000);

(d) The subject-injury sublimit of Ten Million Dollars ($10,000,000) per occurrence and Fifty Million Dollars ($50,000,000) in the aggregate;

(e) The additional insured endorsement in favor of Veridian Health Research Network, Inc., each participating site institution, and each investigator and site staff member acting within the scope of Protocol PPC-4871-III, with notation that such coverage is primary and non-contributory;

(f) The policy period (currently April 1, 2023 through March 31, 2024);

(g) Confirmation that the policy is written on an occurrence basis; and

(h) A cancellation notice provision requiring at least thirty (30) days' prior written notice to the certificate holder.

Site Network's Certificates. Veridian shall deliver certificates of insurance for each participating site institution, and such certificates shall evidence commercial general liability and professional liability coverage meeting the minimum limits specified in Article II of this Exhibit E. Where a site institution is self-insured or participates in a self-insurance program, Veridian shall deliver the actuary or risk manager certification required by Section 2.3 in lieu of a certificate from a commercial insurer, together with a written summary of the self-insurance program's coverage terms and limits.

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 annual renewal certificate obligation arises on or about each April 1 anniversary date, consistent with the current Briarcliff Mutual Insurance Company policy period of April 1 through March 31. In the event that Sponsor changes its policy period or carrier, the renewal certificate obligation shall correspond to the applicable new policy renewal date, and Sponsor shall notify Site Network of any such change promptly upon its occurrence.

For Veridian and each participating site institution, the annual renewal certificate obligation arises on or about each site institution's applicable policy renewal date. Veridian shall maintain a schedule of renewal dates for all participating site institutions and shall use commercially reasonable efforts to ensure timely delivery of updated certificates to Sponsor.

Failure to deliver an annual renewal certificate within the fifteen (15) business day period specified herein shall not, in and of itself, constitute a breach of the Agreement, but shall obligate the delinquent party to deliver the updated certificate promptly upon receipt of written notice from the other party requesting the same. Persistent failure to deliver renewal certificates after reasonable notice may be considered a material breach subject to the remedies set forth in Article V.

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. Associate General Counsel, Clinical Affairs Penterra Pharmaceuticals Corp. 200 Biopharma Boulevard, Suite 1400 Princeton, NJ 08540

And a copy to:

Calderwood & Harkness LLP

Attn: Sean Morrissey

280 Park Avenue, 34th Floor New York, NY 10017

Certificates to Site Network. All certificates of insurance, endorsements, and related insurance documentation required to be delivered to Site Network under this Exhibit E shall be sent to the following addresses:

Veridian Health Research Network, Inc.

Attn: Patricia Dunne, Director, Sponsored Research Agreements

750 Research Parkway, 8th Floor Philadelphia, PA 19104

With a copy to:

Gregory Callahan, Esq. VP, Legal & Compliance Veridian Health Research Network, Inc. 750 Research Parkway, 8th Floor Philadelphia, PA 19104

Certificates and endorsements may be delivered by hand, by overnight courier (e.g., Sundial Data Systems, Halcyon Partners LLC), by U.S. certified mail (return receipt requested), or by electronic transmission (including e-mail with PDF attachment), provided that delivery by electronic transmission shall be followed by delivery of the original certificate or endorsement by hand or mail within ten (10) business days. Either party may update its delivery addresses by providing written notice to the other party in accordance with the notice provisions of the Agreement.

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 effective upon satisfaction of all conditions precedent set forth therein.

No site institution may enroll the first subject at its site in Protocol PPC-4871-III until Sponsor has received a compliant certificate of insurance from such site institution (or, in the case of a self-insured institution, the actuary or risk manager certification required by Section 2.3) evidencing coverage meeting or exceeding the minimum requirements of Article II. Sponsor's Clinical Operations team shall verify receipt of each site institution's certificate prior to authorizing site activation and first-subject enrollment at such site. In the event that a site institution's certificate is deficient, Sponsor shall promptly notify Veridian of the deficiency, and enrollment at such site shall be delayed until a compliant certificate is received.

ARTICLE IV — GENERAL INSURANCE PROVISIONS

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 PPC-4871-III. The waiver of subrogation shall apply to the extent of losses covered by the applicable policy and shall not require the non-insured party to reimburse the insured party or its insurer for amounts paid under the policy.

In the event that a party's insurer declines to include a waiver of subrogation or charges an additional premium for such waiver, the party seeking the waiver shall promptly notify the other party in writing, and the parties shall discuss in good faith whether alternative arrangements are available to achieve substantially the same result. Any additional premium charged by an insurer for including a waiver of subrogation endorsement shall be borne by the party whose insurer charges such premium, unless otherwise agreed in writing by the parties.

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 established under the indemnification provisions of the Agreement or Exhibit D.

Sponsor specifically acknowledges that the deductible under the Briarcliff Mutual Insurance Company policy (Policy No. BM-CTL-2023-04182) is Sponsor's sole obligation and responsibility. The existence of such deductible shall not reduce, limit, or otherwise affect the coverage available to additional insureds under the policy. Sponsor shall satisfy any applicable deductible promptly upon demand by the insurer in connection with any claim involving an additional insured, and the failure or delay of Sponsor in satisfying such deductible shall not impair the coverage available to the additional insured or relieve the insurer of its obligations under the policy.

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 either party shall not be construed as satisfying, replacing, or excusing such party's indemnification obligations under the Agreement, and the indemnification obligations of each party shall apply regardless of whether such party maintains insurance coverage in the amounts required by this Exhibit E.

Maintenance of the required insurance coverage shall not relieve either party of liability under the Agreement in excess of applicable policy limits, nor shall the insurance requirements herein be construed as establishing a cap on either party's liability or indemnification obligations. Each party acknowledges that its obligations under the Agreement, including its indemnification obligations, are independent of and may exceed the coverage available under its insurance policies, and that the failure of an insurer to pay a claim (whether due to policy exclusions, coverage disputes, insurer insolvency, or otherwise) does not relieve the insured party of its underlying obligations to the other party under the Agreement.

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 believe that the other party's insurance coverage is deficient, in which case an additional review may be requested.

The party receiving such a request shall make available copies of the relevant policy declarations pages, endorsements (including the additional insured and waiver of subrogation endorsements), and schedule of coverage limits within fifteen (15) business days of the request. A party is not required to disclose the premium amounts paid under its insurance policies, except to the extent that premium information is directly relevant to verifying the adequacy of coverage.

Any insurance policy information disclosed pursuant to this Section 4.4 shall be treated as Confidential Information of the disclosing party and shall be subject to the confidentiality provisions of the Agreement (Exhibit F — Confidentiality and Non-Disclosure Provisions), including the ten (10) year confidentiality term set forth therein. The receiving party shall limit access to such information to its legal, risk management, and insurance personnel who have a need to know for purposes of verifying compliance with this Exhibit E, and shall not disclose such information to any third party without the prior written consent of the disclosing party, except as required by law, regulation, or court order.

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 study-related injuries sustained by trial subjects in connection with Protocol PPC-4871-III. The sublimit is designed to complement, but not to replace or limit, Sponsor's direct indemnification obligations under Exhibit D.

The per-subject medical care cap of Five Hundred Thousand Dollars ($500,000) and the aggregate medical care cap of Fifteen Million Dollars ($15,000,000) referenced in Exhibit D operate independently of, and are not limited by, the insurance sublimits set forth in Section 1.2(c) of this Exhibit E. Sponsor's indemnification obligations under Exhibit D apply regardless of whether insurance coverage is available, whether a claim is covered under the Briarcliff policy, or whether the insurance sublimits or aggregate limits have been exhausted. In the event that the subject-injury sublimit is exhausted, Sponsor shall remain obligated to satisfy its indemnification obligations under Exhibit D from its own funds and resources.

Sponsor's uncapped indemnification obligation for product-defect claims under Exhibit D (including claims arising from manufacturing defects, design defects, inadequate warnings, contamination, or adulteration of the investigational product penterafenib (PPC-4871)) is supported by the full per-occurrence limit of Twenty-Five Million Dollars ($25,000,000) and the annual aggregate limit of Seventy-Five Million Dollars ($75,000,000) of the clinical trial liability policy. In the event that a product-defect claim exceeds the available policy limits, Sponsor shall remain liable for the full amount of such claim in accordance with the indemnification provisions of the Agreement and Exhibit D, and the policy limits shall not serve as a cap or limitation on Sponsor's indemnification obligations.

ARTICLE V — REMEDIES FOR NON-COMPLIANCE

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 specific section of this Exhibit E with which the breaching party is not in compliance, describe the deficiency in reasonable detail, and state the actions required to cure the deficiency.

The breaching party shall have fifteen (15) business days from receipt of such notice to cure the deficiency by procuring compliant coverage, renewing lapsed coverage, or taking such other corrective action as may be necessary to restore compliance with this Exhibit E, and by delivering to the non-breaching party an updated certificate of insurance or other documentation evidencing that the deficiency has been cured. During the cure period, the breaching party shall keep the non-breaching party reasonably informed of its efforts to cure the deficiency and shall provide such interim assurances or documentation as the non-breaching party may reasonably request.

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 fails to maintain the clinical trial liability insurance required under Article I, Site Network may, upon written notice to Sponsor, suspend enrollment of new subjects and suspend study activities at all participating Veridian Network sites until Sponsor's insurance coverage is fully restored and a compliant certificate of insurance is delivered to Site Network. Any such suspension shall not relieve Sponsor of its obligations to subjects already enrolled in the study at the time of suspension, including Sponsor's obligations to provide or pay for medical care for study-related injuries, to supply investigational product for the treatment of enrolled subjects for whom continued treatment is medically appropriate, and to indemnify Site Network and site institutions in accordance with the Agreement and Exhibit D. Site Network's decision to suspend enrollment and study activities under this Section 5.2(a) shall not constitute a breach of the Agreement by Site Network.

(b) Remedies Available to Sponsor. If any participating Veridian Network site institution fails to maintain the insurance coverage required under Article II, and the deficiency is not cured within the applicable cure period, Sponsor may, upon written notice to Veridian:

(i) Suspend payment of site fees, investigator grants, and per-subject payments to the non-compliant site institution until compliant coverage is restored; and/or

(ii) Terminate the Individual Site Agreement for such non-compliant site institution, effective upon expiration of the cure period, subject to the wind-down provisions described below.

Any termination of an Individual Site Agreement for insurance non-compliance under this Section 5.2 shall be subject to the one hundred twenty (120) day wind-down period specified in the Agreement for the protection of enrolled subjects. During the wind-down period, the terminated site institution shall continue to provide necessary medical care and safety monitoring to enrolled subjects, shall complete any protocol-required follow-up visits or assessments that fall within the wind-down period, shall ensure orderly transfer of subject care and study records to an alternative site or to the subjects' personal physicians, and shall cooperate with Sponsor and Veridian in all aspects of the wind-down process. Sponsor shall continue to make payments for study-related activities performed during the wind-down period in accordance with the payment terms of the Agreement and the applicable Individual Site Agreement.

The remedies set forth in this Article V are cumulative and are not exclusive of any other remedies available to either party under the Agreement, at law, or in equity. The exercise of any remedy under this Article V shall not constitute a waiver of any other right or remedy, and no delay or failure in exercising any remedy shall be construed as a waiver thereof.

APPENDIX E-1

FORM OF CERTIFICATE OF INSURANCE (SPONSOR)

CERTIFICATE OF INSURANCE

COVERAGE LIMITS:

ADDITIONAL INSUREDS: Veridian Health Research Network, Inc.; each participating Veridian Network site institution listed in Schedule 1 to the Master Clinical Trial Agreement dated June 28, 2023; and each investigator and site staff member acting within the scope of Protocol PPC-4871-III. Additional insured coverage is primary and non-contributory.

DESCRIPTION OF OPERATIONS: Insurance is provided in connection with Protocol PPC-4871-III (CLARION — Clinical Assessment of Response with Longitudinal Investigation in ONcology) for the investigational product penterafenib (PPC-4871), IND 157823, ClinicalTrials.gov Identifier NCT05928174, pursuant to the Master Clinical Trial Agreement dated June 28, 2023, by and between Penterra Pharmaceuticals Corp. and Veridian Health Research Network, Inc.

CANCELLATION PROVISION: Should the above-described policy be cancelled, non-renewed, or materially reduced in coverage before the expiration date thereof, the Insurer will endeavor to mail thirty (30) days' written notice to the Certificate Holder at the address shown above. Failure to mail such notice shall impose no obligation or liability of any kind upon the Insurer, its agents, or representatives.

WAIVER OF SUBROGATION: The Insurer has agreed to waive all rights of subrogation against the Certificate Holder and each additional insured with respect to claims arising from or related to Protocol PPC-4871-III, to the extent permitted by law and the terms of the policy.

BRIARCLIFF MUTUAL INSURANCE COMPANY

By: ________

Name: Karen Tremblay (or Designee)

Title: Vice President, Life Sciences Lines

Date: ________

This certificate is issued as a matter of information only and confers no rights upon the certificate holder. This certificate does not amend, extend, or alter the coverage afforded by the above-referenced policy. The insurance afforded by the policy described herein is subject to all the terms, exclusions, and conditions of such policy.

APPENDIX E-2

FORM OF CERTIFICATE OF INSURANCE (SITE NETWORK / SITE INSTITUTION)

CERTIFICATE OF INSURANCE

COVERAGE TYPES AND LIMITS:

DESCRIPTION OF OPERATIONS: Insurance is maintained in connection with [Site Institution]'s participation as a clinical trial site in Protocol PPC-4871-III (CLARION — Clinical Assessment of Response with Longitudinal Investigation in ONcology) for the investigational product penterafenib (PPC-4871), pursuant to the Master Clinical Trial Agreement dated June 28, 2023, by and between Penterra Pharmaceuticals Corp. and Veridian Health Research Network, Inc., and the Individual Site Agreement dated [date] between Penterra Pharmaceuticals Corp. and [Site Institution].

SELF-INSURANCE NOTATION (if applicable): [If the site institution is self-insured or participates in a self-insurance trust, risk-retention group, or captive insurance arrangement, attach the actuary or risk manager certification required by Section 2.3 of Exhibit E, confirming the adequacy and solvency of the self-insurance program. Describe the self-insurance program, including the program name, administrator, coverage limits, and years of continuous operation.]

CANCELLATION PROVISION: Should any of the above-described policies be cancelled, non-renewed, or materially reduced in coverage before the expiration date thereof, the Insurer will endeavor to mail thirty (30) days' written notice to the Certificate Holder at the address shown above. Failure to mail such notice shall impose no obligation or liability of any kind upon the Insurer, its agents, or representatives.

[NAME OF INSURER OR SITE INSTITUTION]

By: ________

Name: [Authorized Representative or Risk Management Officer]

Title: ________

Date: ________

This certificate is issued as a matter of information only and confers no rights upon the certificate holder. This certificate does not amend, extend, or alter the coverage afforded by the above-referenced policies. The insurance afforded by the policies described herein is subject to all the terms, exclusions, and conditions of such policies.

APPENDIX E-3

FORM OF ADDITIONAL INSURED ENDORSEMENT REQUEST

REQUEST FOR ADDITIONAL INSURED ENDORSEMENT

Date: _____

To: Briarcliff Mutual Insurance Company

Attn: Karen Tremblay, Vice President, Life Sciences Lines

55 Constitution Plaza Hartford, CT 06103

From: Penterra Pharmaceuticals Corp. 200 Biopharma Boulevard, Suite 1400 Princeton, NJ 08540

Re: Policy No. BM-CTL-2023-04182 — Request to Add Additional Insureds

Dear Ms. Tremblay:

Reference is made to Clinical Trial Liability Policy No. BM-CTL-2023-04182 (the "Policy"), issued by Briarcliff Mutual Insurance Company (the "Insurer") to Penterra Pharmaceuticals Corp. ("Penterra" or the "Named Insured"), with a current policy period of April 1, 2023 through March 31, 2024.

Penterra has entered into a Master Clinical Trial Agreement dated June 28, 2023 (the "MCTA") with Veridian Health Research Network, Inc. ("Veridian"), a Delaware 501(c)(3) corporation, for the conduct of a multi-center Phase III clinical trial under Protocol PPC-4871-III, known as the CLARION trial (Clinical Assessment of Response with Longitudinal Investigation in ONcology), involving the investigational product penterafenib (PPC-4871), IND Application No. 157823, ClinicalTrials.gov Identifier NCT05928174.

Pursuant to the MCTA and Exhibit E thereto, Penterra is required to cause the Policy to be endorsed to include the following entities and individuals as additional insureds:

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 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-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 of any additional insured. The coverage afforded to additional insureds under the Policy shall apply solely to claims arising out of or related to the conduct of Protocol PPC-4871-III (CLARION) for the investigational product penterafenib (PPC-4871), IND Application No. 157823, ClinicalTrials.gov Identifier NCT05928174, and shall not extend to any claims arising from activities unrelated to the CLARION trial.

Penterra respectfully requests that the Insurer issue an endorsement to the Policy reflecting the addition of the above-listed entities and individuals as additional insureds, on the terms described herein, and that the Insurer issue an updated certificate of insurance reflecting such endorsement. The endorsement and updated certificate should be delivered to the Named Insured at the address set forth above.

A complete list of the thirty-eight (38) participating Veridian Network site institutions is attached hereto as Schedule 1.

We appreciate your prompt attention to this request. Please contact the undersigned or Samantha Novak, Director, Clinical Contracts (telephone: (609) 555-2400; email: snovak@penterra.com), with any questions regarding this request.

PENTERRA PHARMACEUTICALS CORP.

By: ________

Name: Nathaniel Briggs, Esq.

Title: Vice President & General Counsel

Date: ________

PENTERRA PHARMACEUTICALS CORP.

By: ________

Name: Samantha Novak

Title: Director, Clinical Contracts

Date: ________

EXHIBIT E
INSURANCE REQUIREMENTS AND CERTIFICATE FORMS
Attached to and forming part of the Master Clinical Trial Agreement dated June 28, 2023 (the "Agreement"), by and between Penterra Pharmaceuticals Corp., a Delaware corporation ("Sponsor"), and Veridian Health Research Network, Inc., a Delaware 501(c)(3) corporation ("Site Network").
Protocol: Protocol PPC-4871-III ("CLARION" — Clinical Assessment of Response with Longitudinal Investigation in ONcology)
Investigational Product: Penterafenib (PPC-4871)
Capitalized terms used but not otherwise defined in this Exhibit E shall have the meanings ascribed to them in the Agreement.
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ARTICLE I — SPONSOR INSURANCE REQUIREMENTS
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, without limitation, the manufacture, supply, distribution, storage, handling, and administration of the investigational product penterafenib (PPC-4871), as well as the collection and processing of biological samples, the performance of protocol-specified procedures, and the monitoring and oversight activities conducted by or on behalf of Sponsor at each participating site.
The clinical trial liability insurance required under this Section 1.1 shall be procured from and maintained with an insurance carrier rated A- (Excellent) or better by A.M. Best Company, Inc., and such carrier shall be authorized to do business and to write clinical trial liability or comparable coverage in each state in which a participating Veridian Network site is located. Sponsor shall ensure that the carrier's financial size category, as determined by A.M. Best, is no less than Category VIII at all times during the term of the required coverage.
As of the Effective Date of the Agreement, Sponsor's clinical trial liability insurance is provided by the following carrier:
Carrier: Briarcliff Mutual Insurance Company, a mutual insurance company organized under the laws of the State of Connecticut, with principal offices located at 55 Constitution Plaza, Hartford, CT 06103.
Policy Number: BM-CTL-2023-04182
Policy Period: April 1, 2023 through March 31, 2024, renewable annually thereafter.
The Briarcliff Mutual Insurance Company policy shall be renewed annually throughout the entire term of the Agreement and shall be maintained for a minimum of three (3) years following the completion of the last subject's participation in the study, including any follow-up visits, survival monitoring periods, or post-treatment safety assessments required by the Protocol, by any applicable regulatory authority, or by the Agreement. For purposes of this Section 1.1, "completion of the last subject's participation" shall mean the date on which all protocol-required activities, including long-term follow-up, have been completed or formally discontinued for the final enrolled subject across all participating sites.
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 annual aggregate for all claims arising from or related to the conduct of Protocol PPC-4871-III during each policy period.
(c) Subject-Injury Sublimit: Ten Million Dollars ($10,000,000) per occurrence and Fifty Million Dollars ($50,000,000) in the aggregate for claims specifically arising from study-related injuries to trial subjects, as further described below.
The clinical trial liability coverage shall be written on an occurrence basis. In the event that occurrence-basis coverage is unavailable or is replaced by a claims-made policy at any point during the term of coverage, any such claims-made policy shall include a retroactive date no later than the date of first subject enrollment under Protocol PPC-4871-III at any Veridian Network site, and shall provide an extended reporting period (commonly referred to as "tail coverage") of no less than three (3) years following the expiration, cancellation, or non-renewal of such claims-made policy. The cost of any extended reporting period endorsement shall be borne solely by Sponsor.
The subject-injury sublimit described in clause (c) above shall apply specifically to claims for medical costs, hospitalization expenses, rehabilitation costs, and other reasonable and necessary medical expenses arising from study-related injuries to trial subjects when the investigational product penterafenib (PPC-4871) is administered in accordance with the Protocol, and when such injuries are not attributable to the negligence or willful misconduct of Site Network, the site institution, or site personnel. The subject-injury sublimit is intended to correspond to and support Sponsor's obligations under Exhibit D (Subject-Injury Indemnification Provisions) of the Agreement, and the scope and application of this sublimit shall be interpreted consistently with the provisions of Exhibit D. For the avoidance of doubt, the subject-injury sublimit operates within, and does not increase, the per-occurrence and annual aggregate limits set forth in clauses (a) and (b) above.
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 connection with Protocol PPC-4871-III;
(b) Each participating Veridian Network site institution identified in Schedule 1 to the Agreement, including, without limitation:
(i) Graystone University Medical Center (Site 001), located at 1200 University Avenue, Philadelphia, PA 19104;
(ii) Lakemont Medical Center (Site 002), located at 4400 North Michigan Drive, Chicago, IL 60611; and
(iii) Each additional site institution added to Schedule 1 during the term of the Agreement in accordance with the procedures set forth therein;
(c) Each principal investigator, co-principal investigator, sub-investigator, study coordinator, research nurse, pharmacist, and other site staff member acting within the scope of Protocol PPC-4871-III at any participating site, including, specifically:
(i) Dr. Catherine Aldridge, M.D., Ph.D., serving as Global Principal Investigator for Protocol PPC-4871-III; and
(ii) Dr. Howard Matsuoka, M.D., serving as Co-Principal Investigator for Protocol PPC-4871-III.
The additional insured status granted under this Section 1.3 shall apply solely to claims arising out of or related to the conduct of Protocol PPC-4871-III and the use, administration, handling, storage, or distribution of the investigational product penterafenib (PPC-4871). Such additional insured status shall not extend to any claims arising from activities unrelated to the CLARION trial, including, without limitation, standard-of-care clinical activities, other sponsored research, or the site institution's general operations.
The additional insured endorsement shall specify that the coverage afforded to additional insureds is primary and non-contributory with respect to Site Network's and each site institution's own insurance policies, self-insurance programs, or other coverage arrangements. In the event of a covered claim, Sponsor's clinical trial liability policy shall respond first and shall not seek contribution from any insurance maintained by or on behalf of any additional insured, except to the extent that such claim arises from the sole negligence, willful misconduct, or independent breach of the Agreement by the additional insured. The additional insured endorsement shall contain no provision requiring exhaustion of any other insurance available to the additional insureds as a condition of coverage under the Briarcliff policy.
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 actual enrollment timelines and protocol amendments; or
(b) the date of the final enrolled subject's last study visit, including any extended follow-up period required by the Protocol, any applicable regulatory authority (including, without limitation, the United States Food and Drug Administration), any data safety monitoring board recommendation, or the Agreement.
Sponsor shall provide to Site Network at least thirty (30) days' prior written notice of any cancellation, non-renewal, material reduction in coverage limits or scope, or any other material change to the clinical trial liability insurance policy that could adversely affect the coverage available to Site Network, any site institution, or any investigator or site staff member named as an additional insured. For purposes of this Section 1.4, a "material reduction" includes, without limitation, any decrease in the per-occurrence limit, aggregate limit, or subject-injury sublimit below the minimums specified in Section 1.2, any change from occurrence-basis to claims-made coverage without the extended reporting period required by Section 1.2, any removal or material limitation of the additional insured endorsement, or any increase in the deductible or self-insured retention that would materially impair the coverage available to additional insureds.
In the event that the Briarcliff Mutual Insurance Company policy (Policy No. BM-CTL-2023-04182) is replaced by a policy issued by a different carrier at any time during the required coverage period, Sponsor shall:
(a) ensure that the replacement policy provides coverage equivalent to or superior to the coverage afforded under the Briarcliff policy, including the per-occurrence limit, aggregate limit, subject-injury sublimit, additional insured endorsement (primary and non-contributory), and waiver of subrogation;
(b) provide to Site Network updated certificates of insurance and copies of the additional insured endorsement reflecting the replacement carrier and confirming equivalent or superior coverage, within fifteen (15) business days of the effective date of the replacement policy; and
(c) ensure that there is no gap or lapse in coverage between the expiration or cancellation of the Briarcliff policy and the inception of the replacement policy.
Sponsor shall designate an insurance coordinator or other responsible individual within its organization to ensure compliance with the obligations set forth in this Article I, and shall provide the name and contact information of such individual to Site Network upon execution of the Agreement and promptly upon any change in such designation.
ARTICLE II — SITE NETWORK AND SITE INSTITUTION INSURANCE REQUIREMENTS
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 law or professional standards:
(a) Commercial General Liability Insurance. Each participating site institution shall maintain commercial general liability insurance, including coverage for premises liability, operations liability, products/completed operations liability, and contractual liability, with minimum limits of:
(i) Five Million Dollars ($5,000,000) per occurrence; and
(ii) Ten Million Dollars ($10,000,000) in the annual aggregate.
(b) Professional Liability (Errors and Omissions / Medical Malpractice) Insurance. Each participating site institution shall maintain professional liability insurance, including medical malpractice coverage, covering acts, errors, and omissions of physicians, investigators, nurses, pharmacists, study coordinators, and other clinical and research personnel involved in the conduct of Protocol PPC-4871-III, with minimum limits of:
(i) Five Million Dollars ($5,000,000) per occurrence (or per claim, if written on a claims-made basis); and
(ii) Ten Million Dollars ($10,000,000) in the annual aggregate.
The foregoing minimum limits may be satisfied through a combination of primary insurance policies and umbrella or excess liability policies, provided that the umbrella or excess policies follow form to the underlying primary policies and provide coverage on terms no less favorable than the primary policies. All policies maintained under this Section 2.1 shall be issued by insurance carriers rated A- (Excellent) or better by A.M. Best Company, Inc., and authorized to do business in the applicable state or states in which the site institution operates. In the event that any professional liability policy is written on a claims-made basis, such policy shall include a retroactive date no later than the date of first subject enrollment at the applicable site, and the site institution shall maintain either continuous claims-made coverage or an extended reporting period of no less than three (3) years following the cessation of the site institution's participation in the study.
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, statutory workers' compensation requirements unless such opt-out or exemption is expressly permitted under applicable state law and does not impair the protections afforded to employees of the site institution who are involved in the conduct of Protocol PPC-4871-III.
In addition to statutory workers' compensation coverage, each participating site institution shall maintain employer's liability insurance with minimum limits of One Million Dollars ($1,000,000) per occurrence for bodily injury by accident and One Million Dollars ($1,000,000) per employee for bodily injury by disease.
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 met:
(a) The self-insurance program provides coverage and financial protection at least equivalent to the minimum limits specified in Sections 2.1 and 2.2, including both per-occurrence and aggregate limits for general liability and professional liability;
(b) Veridian provides to Sponsor, upon request and no less frequently than annually, a written certification from a qualified actuary (who is a Fellow of the Casualty Actuarial Society or holds equivalent professional credentials) or a qualified risk manager (who holds a Chartered Property Casualty Underwriter or Associate in Risk Management designation, or equivalent) confirming the adequacy, solvency, and financial soundness of the self-insurance program, including a statement that the program maintains sufficient reserves to satisfy claims at the levels required by this Exhibit E;
(c) The self-insurance program has been in continuous operation for a minimum of five (5) years as of the Effective Date of the Agreement, or, in the alternative, the site institution provides evidence of equivalent financial strength satisfactory to Sponsor in its reasonable judgment; and
(d) The self-insurance program is not subject to any pending regulatory action, insolvency proceeding, or material legal challenge that could impair its ability to pay claims arising from the conduct of Protocol PPC-4871-III.
In the event that a site institution's self-insurance program ceases to meet any of the foregoing conditions during the term of the Agreement, Veridian shall promptly notify Sponsor in writing and shall cause the affected site institution to procure commercial insurance meeting the requirements of Sections 2.1 and 2.2 within thirty (30) days of such notification. Failure to procure replacement coverage within such period shall constitute grounds for suspension of the site institution's participation in the study in accordance with Article V of this Exhibit E.
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 compliance of each participating site institution and shall include in each Individual Site Agreement a requirement that the site institution promptly notify Veridian of any change in its insurance coverage that could affect compliance with the requirements of this Article II.
If any participating site institution fails to maintain the required insurance coverage at any time during its participation in Protocol PPC-4871-III, Veridian shall promptly notify Sponsor in writing, specifying the nature of the deficiency, the identity of the affected site institution, and the steps being taken to remedy the deficiency. Upon receipt of such notification, the affected site institution's participation in the study may be suspended, in whole or in part, at Sponsor's election, until compliant insurance coverage is restored and an updated certificate of insurance evidencing such compliant coverage has been delivered to Sponsor. During any period of suspension, the affected site institution shall not enroll new subjects, but shall continue to provide necessary medical care and safety monitoring to any subjects already enrolled at such site, in accordance with the Protocol and applicable ethical and regulatory requirements.
Veridian shall maintain a centralized insurance tracking system or equivalent process to monitor the insurance status of each participating site institution and shall provide to Sponsor, upon reasonable request, a summary report of the insurance coverage maintained by each site institution participating in the CLARION trial.
ARTICLE III — CERTIFICATE EXCHANGE REQUIREMENTS
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's certificate of insurance shall be delivered by or on behalf of Briarcliff Mutual Insurance Company and shall evidence the following:
(a) Policy No. BM-CTL-2023-04182, with the policy type identified as Clinical Trial Liability;
(b) The per-occurrence limit of Twenty-Five Million Dollars ($25,000,000);
(c) The annual aggregate limit of Seventy-Five Million Dollars ($75,000,000);
(d) The subject-injury sublimit of Ten Million Dollars ($10,000,000) per occurrence and Fifty Million Dollars ($50,000,000) in the aggregate;
(e) The additional insured endorsement in favor of Veridian Health Research Network, Inc., each participating site institution, and each investigator and site staff member acting within the scope of Protocol PPC-4871-III, with notation that such coverage is primary and non-contributory;
(f) The policy period (currently April 1, 2023 through March 31, 2024);
(g) Confirmation that the policy is written on an occurrence basis; and
(h) A cancellation notice provision requiring at least thirty (30) days' prior written notice to the certificate holder.
Site Network's Certificates. Veridian shall deliver certificates of insurance for each participating site institution, and such certificates shall evidence commercial general liability and professional liability coverage meeting the minimum limits specified in Article II of this Exhibit E. Where a site institution is self-insured or participates in a self-insurance program, Veridian shall deliver the actuary or risk manager certification required by Section 2.3 in lieu of a certificate from a commercial insurer, together with a written summary of the self-insurance program's coverage terms and limits.
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 annual renewal certificate obligation arises on or about each April 1 anniversary date, consistent with the current Briarcliff Mutual Insurance Company policy period of April 1 through March 31. In the event that Sponsor changes its policy period or carrier, the renewal certificate obligation shall correspond to the applicable new policy renewal date, and Sponsor shall notify Site Network of any such change promptly upon its occurrence.
For Veridian and each participating site institution, the annual renewal certificate obligation arises on or about each site institution's applicable policy renewal date. Veridian shall maintain a schedule of renewal dates for all participating site institutions and shall use commercially reasonable efforts to ensure timely delivery of updated certificates to Sponsor.
Failure to deliver an annual renewal certificate within the fifteen (15) business day period specified herein shall not, in and of itself, constitute a breach of the Agreement, but shall obligate the delinquent party to deliver the updated certificate promptly upon receipt of written notice from the other party requesting the same. Persistent failure to deliver renewal certificates after reasonable notice may be considered a material breach subject to the remedies set forth in Article V.
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. Associate General Counsel, Clinical Affairs Penterra Pharmaceuticals Corp. 200 Biopharma Boulevard, Suite 1400 Princeton, NJ 08540
And a copy to:
Calderwood & Harkness LLP
Attn: Sean Morrissey
280 Park Avenue, 34th Floor New York, NY 10017
Certificates to Site Network. All certificates of insurance, endorsements, and related insurance documentation required to be delivered to Site Network under this Exhibit E shall be sent to the following addresses:
Veridian Health Research Network, Inc.
Attn: Patricia Dunne, Director, Sponsored Research Agreements
750 Research Parkway, 8th Floor Philadelphia, PA 19104
With a copy to:
Gregory Callahan, Esq. VP, Legal & Compliance Veridian Health Research Network, Inc. 750 Research Parkway, 8th Floor Philadelphia, PA 19104
Certificates and endorsements may be delivered by hand, by overnight courier (e.g., Sundial Data Systems, Halcyon Partners LLC), by U.S. certified mail (return receipt requested), or by electronic transmission (including e-mail with PDF attachment), provided that delivery by electronic transmission shall be followed by delivery of the original certificate or endorsement by hand or mail within ten (10) business days. Either party may update its delivery addresses by providing written notice to the other party in accordance with the notice provisions of the Agreement.
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 effective upon satisfaction of all conditions precedent set forth therein.
No site institution may enroll the first subject at its site in Protocol PPC-4871-III until Sponsor has received a compliant certificate of insurance from such site institution (or, in the case of a self-insured institution, the actuary or risk manager certification required by Section 2.3) evidencing coverage meeting or exceeding the minimum requirements of Article II. Sponsor's Clinical Operations team shall verify receipt of each site institution's certificate prior to authorizing site activation and first-subject enrollment at such site. In the event that a site institution's certificate is deficient, Sponsor shall promptly notify Veridian of the deficiency, and enrollment at such site shall be delayed until a compliant certificate is received.
ARTICLE IV — GENERAL INSURANCE PROVISIONS
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 PPC-4871-III. The waiver of subrogation shall apply to the extent of losses covered by the applicable policy and shall not require the non-insured party to reimburse the insured party or its insurer for amounts paid under the policy.
In the event that a party's insurer declines to include a waiver of subrogation or charges an additional premium for such waiver, the party seeking the waiver shall promptly notify the other party in writing, and the parties shall discuss in good faith whether alternative arrangements are available to achieve substantially the same result. Any additional premium charged by an insurer for including a waiver of subrogation endorsement shall be borne by the party whose insurer charges such premium, unless otherwise agreed in writing by the parties.
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 established under the indemnification provisions of the Agreement or Exhibit D.
Sponsor specifically acknowledges that the deductible under the Briarcliff Mutual Insurance Company policy (Policy No. BM-CTL-2023-04182) is Sponsor's sole obligation and responsibility. The existence of such deductible shall not reduce, limit, or otherwise affect the coverage available to additional insureds under the policy. Sponsor shall satisfy any applicable deductible promptly upon demand by the insurer in connection with any claim involving an additional insured, and the failure or delay of Sponsor in satisfying such deductible shall not impair the coverage available to the additional insured or relieve the insurer of its obligations under the policy.
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 either party shall not be construed as satisfying, replacing, or excusing such party's indemnification obligations under the Agreement, and the indemnification obligations of each party shall apply regardless of whether such party maintains insurance coverage in the amounts required by this Exhibit E.
Maintenance of the required insurance coverage shall not relieve either party of liability under the Agreement in excess of applicable policy limits, nor shall the insurance requirements herein be construed as establishing a cap on either party's liability or indemnification obligations. Each party acknowledges that its obligations under the Agreement, including its indemnification obligations, are independent of and may exceed the coverage available under its insurance policies, and that the failure of an insurer to pay a claim (whether due to policy exclusions, coverage disputes, insurer insolvency, or otherwise) does not relieve the insured party of its underlying obligations to the other party under the Agreement.
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 believe that the other party's insurance coverage is deficient, in which case an additional review may be requested.
The party receiving such a request shall make available copies of the relevant policy declarations pages, endorsements (including the additional insured and waiver of subrogation endorsements), and schedule of coverage limits within fifteen (15) business days of the request. A party is not required to disclose the premium amounts paid under its insurance policies, except to the extent that premium information is directly relevant to verifying the adequacy of coverage.
Any insurance policy information disclosed pursuant to this Section 4.4 shall be treated as Confidential Information of the disclosing party and shall be subject to the confidentiality provisions of the Agreement (Exhibit F — Confidentiality and Non-Disclosure Provisions), including the ten (10) year confidentiality term set forth therein. The receiving party shall limit access to such information to its legal, risk management, and insurance personnel who have a need to know for purposes of verifying compliance with this Exhibit E, and shall not disclose such information to any third party without the prior written consent of the disclosing party, except as required by law, regulation, or court order.
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 study-related injuries sustained by trial subjects in connection with Protocol PPC-4871-III. The sublimit is designed to complement, but not to replace or limit, Sponsor's direct indemnification obligations under Exhibit D.
The per-subject medical care cap of Five Hundred Thousand Dollars ($500,000) and the aggregate medical care cap of Fifteen Million Dollars ($15,000,000) referenced in Exhibit D operate independently of, and are not limited by, the insurance sublimits set forth in Section 1.2(c) of this Exhibit E. Sponsor's indemnification obligations under Exhibit D apply regardless of whether insurance coverage is available, whether a claim is covered under the Briarcliff policy, or whether the insurance sublimits or aggregate limits have been exhausted. In the event that the subject-injury sublimit is exhausted, Sponsor shall remain obligated to satisfy its indemnification obligations under Exhibit D from its own funds and resources.
Sponsor's uncapped indemnification obligation for product-defect claims under Exhibit D (including claims arising from manufacturing defects, design defects, inadequate warnings, contamination, or adulteration of the investigational product penterafenib (PPC-4871)) is supported by the full per-occurrence limit of Twenty-Five Million Dollars ($25,000,000) and the annual aggregate limit of Seventy-Five Million Dollars ($75,000,000) of the clinical trial liability policy. In the event that a product-defect claim exceeds the available policy limits, Sponsor shall remain liable for the full amount of such claim in accordance with the indemnification provisions of the Agreement and Exhibit D, and the policy limits shall not serve as a cap or limitation on Sponsor's indemnification obligations.
ARTICLE V — REMEDIES FOR NON-COMPLIANCE
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 specific section of this Exhibit E with which the breaching party is not in compliance, describe the deficiency in reasonable detail, and state the actions required to cure the deficiency.
The breaching party shall have fifteen (15) business days from receipt of such notice to cure the deficiency by procuring compliant coverage, renewing lapsed coverage, or taking such other corrective action as may be necessary to restore compliance with this Exhibit E, and by delivering to the non-breaching party an updated certificate of insurance or other documentation evidencing that the deficiency has been cured. During the cure period, the breaching party shall keep the non-breaching party reasonably informed of its efforts to cure the deficiency and shall provide such interim assurances or documentation as the non-breaching party may reasonably request.
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 fails to maintain the clinical trial liability insurance required under Article I, Site Network may, upon written notice to Sponsor, suspend enrollment of new subjects and suspend study activities at all participating Veridian Network sites until Sponsor's insurance coverage is fully restored and a compliant certificate of insurance is delivered to Site Network. Any such suspension shall not relieve Sponsor of its obligations to subjects already enrolled in the study at the time of suspension, including Sponsor's obligations to provide or pay for medical care for study-related injuries, to supply investigational product for the treatment of enrolled subjects for whom continued treatment is medically appropriate, and to indemnify Site Network and site institutions in accordance with the Agreement and Exhibit D. Site Network's decision to suspend enrollment and study activities under this Section 5.2(a) shall not constitute a breach of the Agreement by Site Network.
(b) Remedies Available to Sponsor. If any participating Veridian Network site institution fails to maintain the insurance coverage required under Article II, and the deficiency is not cured within the applicable cure period, Sponsor may, upon written notice to Veridian:
(i) Suspend payment of site fees, investigator grants, and per-subject payments to the non-compliant site institution until compliant coverage is restored; and/or
(ii) Terminate the Individual Site Agreement for such non-compliant site institution, effective upon expiration of the cure period, subject to the wind-down provisions described below.
Any termination of an Individual Site Agreement for insurance non-compliance under this Section 5.2 shall be subject to the one hundred twenty (120) day wind-down period specified in the Agreement for the protection of enrolled subjects. During the wind-down period, the terminated site institution shall continue to provide necessary medical care and safety monitoring to enrolled subjects, shall complete any protocol-required follow-up visits or assessments that fall within the wind-down period, shall ensure orderly transfer of subject care and study records to an alternative site or to the subjects' personal physicians, and shall cooperate with Sponsor and Veridian in all aspects of the wind-down process. Sponsor shall continue to make payments for study-related activities performed during the wind-down period in accordance with the payment terms of the Agreement and the applicable Individual Site Agreement.
The remedies set forth in this Article V are cumulative and are not exclusive of any other remedies available to either party under the Agreement, at law, or in equity. The exercise of any remedy under this Article V shall not constitute a waiver of any other right or remedy, and no delay or failure in exercising any remedy shall be construed as a waiver thereof.
APPENDIX E-1
FORM OF CERTIFICATE OF INSURANCE (SPONSOR)
CERTIFICATE OF INSURANCE
COVERAGE LIMITS:
ADDITIONAL INSUREDS: Veridian Health Research Network, Inc.; each participating Veridian Network site institution listed in Schedule 1 to the Master Clinical Trial Agreement dated June 28, 2023; and each investigator and site staff member acting within the scope of Protocol PPC-4871-III. Additional insured coverage is primary and non-contributory.
DESCRIPTION OF OPERATIONS: Insurance is provided in connection with Protocol PPC-4871-III (CLARION — Clinical Assessment of Response with Longitudinal Investigation in ONcology) for the investigational product penterafenib (PPC-4871), IND 157823, ClinicalTrials.gov Identifier NCT05928174, pursuant to the Master Clinical Trial Agreement dated June 28, 2023, by and between Penterra Pharmaceuticals Corp. and Veridian Health Research Network, Inc.
CANCELLATION PROVISION: Should the above-described policy be cancelled, non-renewed, or materially reduced in coverage before the expiration date thereof, the Insurer will endeavor to mail thirty (30) days' written notice to the Certificate Holder at the address shown above. Failure to mail such notice shall impose no obligation or liability of any kind upon the Insurer, its agents, or representatives.
WAIVER OF SUBROGATION: The Insurer has agreed to waive all rights of subrogation against the Certificate Holder and each additional insured with respect to claims arising from or related to Protocol PPC-4871-III, to the extent permitted by law and the terms of the policy.
BRIARCLIFF MUTUAL INSURANCE COMPANY
By: ________
Name: Karen Tremblay (or Designee)
Title: Vice President, Life Sciences Lines
Date: ________
This certificate is issued as a matter of information only and confers no rights upon the certificate holder. This certificate does not amend, extend, or alter the coverage afforded by the above-referenced policy. The insurance afforded by the policy described herein is subject to all the terms, exclusions, and conditions of such policy.
APPENDIX E-2
FORM OF CERTIFICATE OF INSURANCE (SITE NETWORK / SITE INSTITUTION)
CERTIFICATE OF INSURANCE
COVERAGE TYPES AND LIMITS:
DESCRIPTION OF OPERATIONS: Insurance is maintained in connection with [Site Institution]'s participation as a clinical trial site in Protocol PPC-4871-III (CLARION — Clinical Assessment of Response with Longitudinal Investigation in ONcology) for the investigational product penterafenib (PPC-4871), pursuant to the Master Clinical Trial Agreement dated June 28, 2023, by and between Penterra Pharmaceuticals Corp. and Veridian Health Research Network, Inc., and the Individual Site Agreement dated [date] between Penterra Pharmaceuticals Corp. and [Site Institution].
SELF-INSURANCE NOTATION (if applicable): [If the site institution is self-insured or participates in a self-insurance trust, risk-retention group, or captive insurance arrangement, attach the actuary or risk manager certification required by Section 2.3 of Exhibit E, confirming the adequacy and solvency of the self-insurance program. Describe the self-insurance program, including the program name, administrator, coverage limits, and years of continuous operation.]
CANCELLATION PROVISION: Should any of the above-described policies be cancelled, non-renewed, or materially reduced in coverage before the expiration date thereof, the Insurer will endeavor to mail thirty (30) days' written notice to the Certificate Holder at the address shown above. Failure to mail such notice shall impose no obligation or liability of any kind upon the Insurer, its agents, or representatives.
[NAME OF INSURER OR SITE INSTITUTION]
By: ________
Name: [Authorized Representative or Risk Management Officer]
Title: ________
Date: ________
This certificate is issued as a matter of information only and confers no rights upon the certificate holder. This certificate does not amend, extend, or alter the coverage afforded by the above-referenced policies. The insurance afforded by the policies described herein is subject to all the terms, exclusions, and conditions of such policies.
APPENDIX E-3
FORM OF ADDITIONAL INSURED ENDORSEMENT REQUEST
REQUEST FOR ADDITIONAL INSURED ENDORSEMENT
Date: _____
To: Briarcliff Mutual Insurance Company
Attn: Karen Tremblay, Vice President, Life Sciences Lines
55 Constitution Plaza Hartford, CT 06103
From: Penterra Pharmaceuticals Corp. 200 Biopharma Boulevard, Suite 1400 Princeton, NJ 08540
Re: Policy No. BM-CTL-2023-04182 — Request to Add Additional Insureds
Dear Ms. Tremblay:
Reference is made to Clinical Trial Liability Policy No. BM-CTL-2023-04182 (the "Policy"), issued by Briarcliff Mutual Insurance Company (the "Insurer") to Penterra Pharmaceuticals Corp. ("Penterra" or the "Named Insured"), with a current policy period of April 1, 2023 through March 31, 2024.
Penterra has entered into a Master Clinical Trial Agreement dated June 28, 2023 (the "MCTA") with Veridian Health Research Network, Inc. ("Veridian"), a Delaware 501(c)(3) corporation, for the conduct of a multi-center Phase III clinical trial under Protocol PPC-4871-III, known as the CLARION trial (Clinical Assessment of Response with Longitudinal Investigation in ONcology), involving the investigational product penterafenib (PPC-4871), IND Application No. 157823, ClinicalTrials.gov Identifier NCT05928174.
Pursuant to the MCTA and Exhibit E thereto, Penterra is required to cause the Policy to be endorsed to include the following entities and individuals as additional insureds:
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 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-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 of any additional insured. The coverage afforded to additional insureds under the Policy shall apply solely to claims arising out of or related to the conduct of Protocol PPC-4871-III (CLARION) for the investigational product penterafenib (PPC-4871), IND Application No. 157823, ClinicalTrials.gov Identifier NCT05928174, and shall not extend to any claims arising from activities unrelated to the CLARION trial.
Penterra respectfully requests that the Insurer issue an endorsement to the Policy reflecting the addition of the above-listed entities and individuals as additional insureds, on the terms described herein, and that the Insurer issue an updated certificate of insurance reflecting such endorsement. The endorsement and updated certificate should be delivered to the Named Insured at the address set forth above.
A complete list of the thirty-eight (38) participating Veridian Network site institutions is attached hereto as Schedule 1.
We appreciate your prompt attention to this request. Please contact the undersigned or Samantha Novak, Director, Clinical Contracts (telephone: (609) 555-2400; email: snovak@penterra.com), with any questions regarding this request.
PENTERRA PHARMACEUTICALS CORP.
By: ________
Name: Nathaniel Briggs, Esq.
Title: Vice President & General Counsel
Date: ________
or
PENTERRA PHARMACEUTICALS CORP.
By: ________
Name: Samantha Novak
Title: Director, Clinical Contracts
Date: ________
Attachment: Schedule 1 — List of Participating Veridian Network Sites
APPENDIX E-4
FORM OF ADDITIONAL INSURED ENDORSEMENT
ADDITIONAL INSURED ENDORSEMENT
This endorsement modifies the insurance provided under the above-referenced Clinical Trial Liability Policy issued by Briarcliff Mutual Insurance Company to Penterra Pharmaceuticals Corp.
SCHEDULE OF ADDITIONAL INSUREDS. The following entities and individuals are added as additional insureds under the Policy, but only with respect to liability arising out of the Named Insured's sponsorship and conduct of Protocol PPC-4871-III (CLARION — Clinical Assessment of Response with Longitudinal Investigation in ONcology) involving the investigational product penterafenib (PPC-4871), IND Application No. 157823, ClinicalTrials.gov Identifier NCT05928174:
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 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 by written notice from the Named Insured to the Insurer as additional sites are activated or existing sites are deactivated under the MCTA.
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 additional insureds listed above under this endorsement shall be primary and non-contributory with respect to any other insurance or self-insurance maintained by or on behalf of any additional insured. In the event of a covered claim, this Policy shall respond first and shall not seek contribution from any other insurance available to the additional insureds, except to the extent that such claim arises from the sole negligence, willful misconduct, or independent breach of the Master Clinical Trial Agreement by the additional insured.
SCOPE OF COVERAGE. The additional insured coverage provided by this endorsement applies solely to claims arising out of or related to the conduct of Protocol PPC-4871-III and the manufacture, supply, distribution, storage, handling, administration, and use of the investigational product penterafenib (PPC-4871). This endorsement does not provide coverage for any claims arising from activities unrelated to Protocol PPC-4871-III.
COVERAGE LIMITS. The coverage available to additional insureds under this endorsement is subject to and shall not exceed the following policy limits:
The limits of liability available to additional insureds are included within, and are not in addition to, the Named Insured's overall policy limits. Claims paid on behalf of additional insureds shall reduce the Named Insured's available limits accordingly.
NO OTHER CHANGES. All other terms, conditions, limitations, and exclusions of the Policy remain unchanged and in full force and effect. This endorsement is subject to all the terms, conditions, and exclusions of the Policy, except as specifically modified herein.
BRIARCLIFF MUTUAL INSURANCE COMPANY
By: ________
Name: Karen Tremblay (or Authorized Designee)
Title: Vice President, Life Sciences Lines
Date: ________
This endorsement forms a part of the Policy to which it is attached. It is effective on the date shown above and applies to all occurrences arising on or after such date during the policy period.
ACKNOWLEDGMENT AND EXECUTION
This Exhibit E, including Appendices E-1 through E-4, is incorporated into and forms an integral part of the Master Clinical Trial Agreement dated June 28, 2023, by and between Penterra Pharmaceuticals Corp. and Veridian Health Research Network, Inc. Each party acknowledges that it has reviewed and understands the insurance requirements and obligations set forth herein and agrees to comply fully with all provisions of this Exhibit E throughout the term of the Agreement and for such additional periods as are specified herein.
By executing this Exhibit E below, each party represents and warrants that, as of the date of execution, it either maintains or has taken all steps necessary to procure the insurance coverage required under this Exhibit E, and that it will deliver to the other party the certificates of insurance and other documentation required by Article III within the timeframes specified therein.
IN WITNESS WHEREOF, the parties have caused this Exhibit E to be executed by their duly authorized representatives as of the date first written above.
SPONSOR:
PENTERRA PHARMACEUTICALS CORP.
By: ________
Name: Nathaniel Briggs, Esq.
Title: Vice President & General Counsel
Date: June 28, 2023
SITE NETWORK:
VERIDIAN HEALTH RESEARCH NETWORK, INC.
By: ________
Name: Dr. Franklin Osei, M.D., Ph.D.
Title: President & Chief Executive Officer
Date: June 28, 2023
Field | Information
Certificate Holder: | Veridian Health Research Network, Inc., 750 Research Parkway, 8th Floor, Philadelphia, PA 19104
Insured: | Penterra Pharmaceuticals Corp., 200 Biopharma Boulevard, Suite 1400, Princeton, NJ 08540
Insurer: | Briarcliff Mutual Insurance Company, 55 Constitution Plaza, Hartford, CT 06103
A.M. Best Rating: | A- (Excellent), Financial Size Category VIII or higher
Policy Number: | BM-CTL-2023-04182
Policy Type: | Clinical Trial Liability
Policy Period: | Inception Date: April 1, 2023 — Expiration Date: March 31, 2024
Coverage Basis: | Occurrence
Coverage | Per Occurrence | Aggregate
Clinical Trial Liability | $25,000,000 | $75,000,000
Subject-Injury Sublimit | $10,000,000 | $50,000,000
Field | Information
Certificate Holder: | Penterra Pharmaceuticals Corp., 200 Biopharma Boulevard, Suite 1400, Princeton, NJ 08540
Insured: | [Name of Veridian Network Site Institution] (e.g., Graystone University Medical Center, 1200 University Avenue, Philadelphia, PA 19104)
Insurer(s): | [Name and address of insurer(s)]
A.M. Best Rating(s): | [A- (Excellent) or better]
Policy Number(s): | [To be provided for each coverage type]
Policy Period: | Inception Date: [Date] — Expiration Date: [Date]
Coverage Type | Per Occurrence / Per Claim | Aggregate
Commercial General Liability | $5,000,000 (minimum) | $10,000,000 (minimum)
Professional Liability / Medical Malpractice | $5,000,000 (minimum) | $10,000,000 (minimum)
Workers' Compensation | Statutory Limits | Statutory Limits
Employer's Liability | $1,000,000 | N/A
Field | Information
Endorsement to Policy No.: | BM-CTL-2023-04182
Named Insured: | Penterra Pharmaceuticals Corp., 200 Biopharma Boulevard, Suite 1400, Princeton, NJ 08540
Insurer: | Briarcliff Mutual Insurance Company, 55 Constitution Plaza, Hartford, CT 06103
Effective Date of Endorsement: | [Date of endorsement]
Coverage | Per Occurrence | Aggregate
Clinical Trial Liability | $25,000,000 | $75,000,000
Subject-Injury Sublimit | $10,000,000 | $50,000,000

EXHIBIT E

INSURANCE REQUIREMENTS AND CERTIFICATE FORMS

APPENDIX E-1

FORM OF CERTIFICATE OF INSURANCE (SPONSOR)

CERTIFICATE OF INSURANCE

COVERAGE LIMITS:

BRIARCLIFF MUTUAL INSURANCE COMPANY

APPENDIX E-2

FORM OF CERTIFICATE OF INSURANCE (SITE NETWORK / SITE INSTITUTION)

CERTIFICATE OF INSURANCE

COVERAGE TYPES AND LIMITS:

APPENDIX E-3

FORM OF ADDITIONAL INSURED ENDORSEMENT REQUEST

REQUEST FOR ADDITIONAL INSURED ENDORSEMENT

PENTERRA PHARMACEUTICALS CORP.

PENTERRA PHARMACEUTICALS CORP.

Record

Parties

Dates

Amounts