1018-00004 · Penterra Pharmaceuticals Corp · Insurance

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CALDERWOOD & HARKNESS LLP Attorneys at Law

280 Park Avenue, 34th Floor New York, New York 10017 Telephone: (212) 549-7000 Facsimile: (212) 549-7001

101 Carnegie Center, Suite 500 Princeton, New Jersey 08540 Telephone: (609) 452-8800 Facsimile: (609) 452-8801

www.calderwoodharkness.com

June 29, 2023

Via Email and Sundial Data Systems

Ms. Karen Tremblay Vice President, Life Sciences Lines Briarcliff Mutual Insurance Company 55 Constitution Plaza Hartford, CT 06103

Re: Request for Additional Insured Endorsement — Clinical Trial Liability Policy No. BM-CTL-2023-04182 Insured: Penterra Pharmaceuticals Corp. Policy Period: April 1, 2023 – March 31, 2024 Protocol: PPC-4871-III (CLARION Trial)

Dear Ms. Tremblay:

This firm represents Penterra Pharmaceuticals Corp. ("Penterra"), a Delaware corporation headquartered at 200 Biopharma Boulevard, Suite 1400, Princeton, New Jersey 08540, and publicly traded on the Nasdaq Global Select Market under the ticker symbol PTRA. We are writing on behalf of Penterra in connection with its clinical trial liability insurance policy issued by Briarcliff Mutual Insurance Company ("Briarcliff" or the "Company"), bearing Policy No. BM-CTL-2023-04182, with a current policy period of April 1, 2023 through March 31, 2024 (renewable annually) (the "Policy"). The purpose of this letter is to formally request that Briarcliff endorse the Policy to add certain parties as additional insureds in connection with a Phase III clinical trial that Penterra is sponsoring, as more fully described below. Given the contractual deadlines governing this matter, we respectfully request Briarcliff's expedited attention to this request.

I. BACKGROUND — THE CLARION TRIAL

Penterra is the sponsor of Protocol PPC-4871-III, a pivotal Phase III clinical trial titled "CLARION — Clinical Assessment of Response with Longitudinal Investigation in ONcology." The CLARION trial is designed to evaluate the safety and efficacy of penterafenib (PPC-4871), an oral multi-kinase inhibitor, in patients with advanced hepatocellular carcinoma ("HCC") who have experienced disease progression following at least one prior line of systemic therapy in the second-line setting.

The CLARION trial is a randomized, double-blind, placebo-controlled, multi-center study conducted under Investigational New Drug Application No. IND 157823, on file with the United States Food and Drug Administration, Center for Drug Evaluation and Research. The study is registered on the ClinicalTrials.gov database under Identifier No. NCT05928174.

The trial design calls for planned enrollment of approximately 1,200 subjects, randomized in a 2:1 ratio (penterafenib to placebo), yielding approximately 800 subjects in the active treatment arm and approximately 400 subjects in the placebo control arm. The projected enrollment period is 42 months from first patient in, with a target first-patient-in date of August 14, 2023. The estimated total study duration, inclusive of the enrollment period and an 18-month post-enrollment follow-up period, is approximately 60 months.

The CLARION trial represents a critical regulatory milestone for Penterra's lead oncology pipeline candidate and, upon successful completion, is expected to support a New Drug Application submission to the FDA for the penterafenib HCC indication.

II. BACKGROUND — MASTER CLINICAL TRIAL AGREEMENT WITH VERIDIAN

On June 28, 2023, Penterra executed a Master Clinical Trial Agreement (the "MCTA") with Veridian Health Research Network, Inc. ("Veridian"), a Delaware corporation organized as a tax-exempt entity under Section 501(c)(3) of the Internal Revenue Code (EIN: 23-4178205), with its principal offices located at 750 Research Parkway, 8th Floor, Philadelphia, Pennsylvania 19104. Veridian operates a nationally recognized network of 38 academic medical centers and affiliated research institutions spanning 14 states, and serves as the coordinating site network organization for the CLARION trial.

The MCTA governs the overall clinical research relationship between Penterra and Veridian in connection with the conduct of the CLARION trial across the Veridian Network. The MCTA has a total estimated deal value of approximately $80,000,000, encompassing site fees, per-patient payments, investigator grants, monitoring and operational costs, and related expenditures over the projected life of the trial.

Critically, the MCTA imposes certain insurance obligations on Penterra. Specifically:

(a) Minimum Limits. Under Section 14.1 of the MCTA, Penterra is required to maintain clinical trial liability insurance with minimum limits of not less than $25,000,000 per occurrence and $75,000,000 in the aggregate for the duration of the trial and for a reasonable period thereafter.

(b) Additional Insured Requirement. Under Section 14.2 of the MCTA, Penterra is required to name Veridian and each participating Veridian Network site institution, together with their respective officers, directors, employees, agents, principal investigators, sub-investigators, and research staff (collectively, the "Site Personnel"), as additional insureds under Penterra's clinical trial liability policy, with respect to claims arising out of or related to the conduct of the CLARION trial.

(c) Certificate Delivery Deadline. Under Section 14.3 of the MCTA, certificates of insurance evidencing such additional insured status must be delivered to Veridian no later than 15 business days following the date of execution of the MCTA — that is, by approximately July 20, 2023. However, the delivery of satisfactory insurance certificates is also a condition precedent to the closing of the MCTA, which is scheduled for July 5, 2023, as set forth in Section 3.2 of the MCTA.

(d) Tail Coverage. Under Section 14.4 of the MCTA, Penterra's insurance must remain in effect throughout the duration of the trial and for a reasonable period thereafter, consistent with the applicable statute of limitations for personal injury claims in the jurisdictions where participating sites are located.

We enclose herewith, for Briarcliff's reference, relevant excerpts from MCTA Exhibit E (Insurance Requirements and Certificate Forms), which sets forth in detail the insurance specifications required under the agreement.

III. CURRENT POLICY COVERAGE SUMMARY

For ease of reference, we summarize below the current terms of Policy No. BM-CTL-2023-04182 as they pertain to this request:

We understand that the Policy's existing terms, including the limits of liability set forth above, satisfy the minimum insurance requirements under Section 14.1 of the MCTA. The present request concerns solely the addition of the parties identified below as additional insureds under the Policy, and is not a request to modify the limits of liability or other substantive coverage terms.

IV. FORMAL REQUEST FOR ADDITIONAL INSURED ENDORSEMENT

Penterra hereby requests that Briarcliff endorse Policy No. BM-CTL-2023-04182 to name the following parties as additional insureds under the Policy, effective as of the date of issuance of the endorsement:

A. Primary Additional Insured — Veridian Health Research Network, Inc.

Full Legal Name: Veridian Health Research Network, Inc.

Address: 750 Research Parkway, 8th Floor, Philadelphia, Pennsylvania 19104

Entity Type: Delaware corporation, tax-exempt under Section 501(c)(3) of the Internal Revenue Code

Role: Site network counterparty under the MCTA; coordinating organization for all 38 participating clinical trial sites in the Veridian Network

Veridian serves as the central contracting entity for the Veridian Network and bears primary responsibility for the operational coordination and oversight of the participating sites conducting the CLARION trial. As the counterparty to the MCTA, Veridian has a direct contractual relationship with Penterra and is the first-named beneficiary of the additional insured requirement set forth in Section 14.2 of the agreement.

B. Additional Insureds — Participating Veridian Network Site Institutions

Penterra further requests that each of the 38 participating Veridian Network site institutions across 14 states be added as additional insureds under the Policy. Coverage should extend to each site institution as an entity, and should also extend to such institution's officers, directors, employees, agents, principal investigators, sub-investigators, study coordinators, pharmacists, nurses, and other research staff acting within the scope of their duties in connection with the conduct of the CLARION trial.

A complete listing of all 38 participating sites, including site numbers, full institutional names, addresses, and state of organization, is set forth in the enclosed Schedule 1 — List of Participating Veridian Network Sites, which is attached hereto and incorporated by reference into this request.

For Briarcliff's immediate reference, we identify below the five designated lead sites under the MCTA:

Site 001 — Graystone University Medical Center 1200 University Avenue, Philadelphia, Pennsylvania 19104 Pennsylvania nonprofit corporation Principal Investigator: Catherine Aldridge, M.D., Ph.D. (Dr. Aldridge serves as Global Principal Investigator for the CLARION trial)

Site 002 — Lakemont Medical Center 4400 North Michigan Drive, Chicago, Illinois 60611 Illinois nonprofit corporation Co-Principal Investigator: Howard Matsuoka, M.D.

Site 003 — Haverford Regional Medical Center Boston, Massachusetts (Full address set forth in Schedule 1)

Site 004 — Cedar Falls University Hospital Denver, Colorado (Full address set forth in Schedule 1)

Site 005 — Weston Memorial Health System Atlanta, Georgia (Full address set forth in Schedule 1)

The remaining 33 participating sites are identified in full detail on the enclosed Schedule 1.

C. Mechanism for Adding Future Sites

We note that additional sites may be activated during the projected 42-month enrollment period as new institutions execute Individual Site Agreements (in the form of joinder agreements) under the MCTA framework. Penterra respectfully requests that Briarcliff provide a mechanism — whether by means of a blanket endorsement covering all Veridian Network institutions that execute joinders under the MCTA, or alternatively through an expedited amendment or endorsement process — for the addition of such future sites as additional insureds as they are activated throughout the enrollment period. A blanket endorsement covering all current and future Veridian Network participating sites would be the most administratively efficient approach and would best serve the needs of the parties. We are, however, prepared to discuss alternative arrangements that Briarcliff may prefer.

V. SCOPE OF ADDITIONAL INSURED COVERAGE REQUESTED

The additional insured endorsement should provide coverage to the above-named additional insureds with respect to claims arising out of or related to the following:

(a) Bodily injury, personal injury, or death of a trial subject caused by the investigational product (penterafenib / PPC-4871) when administered in accordance with the protocol for Protocol PPC-4871-III, including but not limited to adverse drug reactions, adverse events, serious adverse events, and suspected unexpected serious adverse reactions;

(b) Any defect in the design, manufacture, formulation, labeling, packaging, storage, or supply of the investigational product, including any failure of the investigational product to conform to applicable specifications, or any contamination, adulteration, or mislabeling thereof;

(c) Penterra's indemnification obligations under the MCTA, including without limitation the subject-injury indemnification provisions set forth in MCTA Exhibit D, and any defense and hold-harmless obligations owed by Penterra to Veridian, the participating sites, and Site Personnel under Sections 12.1 through 12.4 of the MCTA;

(d) Activities performed by the additional insureds, their officers, directors, employees, agents, principal investigators, sub-investigators, and research staff in connection with the conduct of the CLARION trial, to the extent such activities are performed within the scope of the protocol and the MCTA; and

(e) Any regulatory or governmental investigation, proceeding, or enforcement action arising out of or related to the conduct of the CLARION trial, to the extent such matters are covered under the terms and conditions of the Policy.

In addition, Penterra requests that the additional insured coverage be endorsed as primary and non-contributory with respect to any insurance maintained by the additional insureds themselves, including without limitation any institutional professional liability, general liability, or umbrella/excess liability coverage maintained by Veridian or any participating site institution. The additional insureds' own insurance, if any, should apply as excess over and non-contributory with the coverage afforded under the Policy.

Penterra further requests a waiver of subrogation in favor of all additional insureds, to the extent permitted under the terms and conditions of the Policy and applicable law. This waiver of subrogation is consistent with the mutual waiver provisions set forth in Section 12.5 of the MCTA and is essential to the harmonious allocation of risk among the parties to the clinical trial.

VI. CONSISTENCY WITH MCTA INDEMNIFICATION AND INSURANCE PROVISIONS

The additional insured endorsement requested herein is intended to be consistent with, and supportive of, Penterra's contractual indemnification obligations under the MCTA. For Briarcliff's reference, we summarize the key indemnification provisions below:

(a) Under MCTA Exhibit D (Subject-Injury Indemnification Provisions), Penterra has agreed to indemnify, defend, and hold harmless Veridian, each participating site institution, and each institution's Site Personnel from and against any and all claims, losses, damages, liabilities, costs, and expenses (including reasonable attorneys' fees) arising out of or resulting from: (i) product-related subject injury, including injury attributable to the investigational product or its administration in accordance with the protocol; (ii) any defect in the investigational product; and (iii) Penterra's negligence or willful misconduct in connection with the trial.

(b) MCTA Exhibit D establishes a per-subject cap on subject-injury medical care costs of $500,000 per individual subject, and an aggregate cap of $15,000,000 on all subject-injury medical care costs across all subjects enrolled in the trial. These caps relate to Penterra's direct medical cost reimbursement obligations and do not limit Penterra's broader indemnification obligations for claims and liabilities.

(c) Under MCTA Exhibit E (Insurance Requirements and Certificate Forms), the insurance maintained by Penterra must (i) name Veridian and each participating site as additional insureds, (ii) be primary and non-contributory, (iii) include a waiver of subrogation in favor of the additional insureds, (iv) provide for 30 days' prior written notice to additional insureds of cancellation or material modification, and (v) remain in effect throughout the trial and for a reasonable period thereafter.

The additional insured endorsement should be structured so as to align with, and provide insurance support for, the foregoing contractual obligations. We enclose herewith the relevant excerpts from MCTA Exhibit E for Briarcliff's review and reference in preparing the endorsement.

VII. REQUESTED DELIVERABLES

Penterra respectfully requests that Briarcliff prepare and deliver the following documents to Calderwood & Harkness at the address set forth above:

1. Endorsement. A formal endorsement to Policy No. BM-CTL-2023-04182 reflecting the additional insured status of Veridian Health Research Network, Inc. and each of the 38 participating Veridian Network site institutions (and their respective officers, directors, employees, agents, and Site Personnel), as described in Sections IV and V above.

2. Updated Certificate(s) of Insurance. Updated certificate(s) of insurance, in a form acceptable under Exhibit E of the MCTA, reflecting the following:

(a) The names of all additional insureds, including Veridian and each participating site institution;

(b) The Policy number (BM-CTL-2023-04182), the per-occurrence limit ($25,000,000), the aggregate limit ($75,000,000), and the subject-injury sublimit ($10,000,000 per occurrence / $50,000,000 aggregate);

(d) A notation that the additional insured coverage is primary and non-contributory;

(e) A notation that the Policy includes a waiver of subrogation in favor of the additional insureds; and

(f) A statement that the Company will provide no less than 30 days' prior written notice to each additional insured (or to Veridian on behalf of all additional insureds) in the event of cancellation, non-renewal, or material modification of the Policy.

3. Multiple Copies. Multiple original copies of the certificates of insurance for distribution to Veridian and to each individual participating site institution. We anticipate requiring at least 40 original certificates — one for Veridian's master file and one for each of the 38 participating sites, plus one additional copy for Penterra's records.

4. Conformity with MCTA Requirements. We request that all certificates be issued in a form acceptable under Exhibit E of the MCTA, a copy of which is enclosed herewith for Briarcliff's reference. To the extent that Briarcliff's standard certificate form differs in any material respect from the form required under Exhibit E, we ask that Briarcliff advise us promptly so that we may coordinate with Veridian's counsel to resolve any discrepancies.

VIII. TIMING AND URGENCY

We wish to emphasize the time-sensitive nature of this request. As noted above, the MCTA requires delivery of insurance certificates evidencing additional insured status within 15 business days of execution (i.e., by approximately July 20, 2023). However, the delivery of satisfactory insurance certificates and evidence of the additional insured endorsement is also a condition precedent to the closing of the MCTA, which is scheduled for July 5, 2023. Failure to deliver the required insurance documentation by the closing date could result in a delay to the closing, a delay to the commencement of the CLARION trial, and potential contractual consequences for Penterra under the MCTA.

Accordingly, Penterra respectfully requests that Briarcliff process the endorsement and issue the requested certificates on an expedited basis, with delivery to Calderwood & Harkness no later than July 3, 2023, in order to allow sufficient time for our review and for timely delivery to Veridian's counsel, Whitmore, Jansen & Callahan LLP, at 1500 Market Street, Suite 3200, Philadelphia, Pennsylvania 19102, in advance of the July 5, 2023 closing date.

We recognize that this is an accelerated timeline and appreciate Briarcliff's willingness to accommodate this request. If Briarcliff anticipates any difficulty in meeting this deadline, we ask that you contact the undersigned immediately so that we may discuss alternative arrangements.

IX. PREMIUM AND BILLING

We understand that the addition of additional insureds to the Policy may result in an additional premium charge or endorsement fee. Penterra requests that Briarcliff provide a premium quotation or invoice for any such additional charges, directed to the attention of:

Ms. Samantha Novak Director, Clinical Contracts Penterra Pharmaceuticals Corp. 200 Biopharma Boulevard, Suite 1400 Princeton, New Jersey 08540 Telephone: (609) 555-4120

Email: s.novak@penterrapharma.com

Penterra is prepared to remit any additional premium or endorsement fee promptly upon receipt of Briarcliff's invoice. If Briarcliff requires advance payment of additional premium as a condition to issuing the endorsement, please advise us immediately so that payment can be arranged without delay.

X. CONTACT INFORMATION FOR COORDINATION

For purposes of coordinating the preparation and delivery of the endorsement and certificates, the following individuals should serve as points of contact:

Calderwood & Harkness LLP (Outside Counsel):

Sean Morrissey, Esq. Associate, Healthcare & Life Sciences Practice Group Calderwood & Harkness LLP 280 Park Avenue, 34th Floor New York, New York 10017 Telephone: (212) 549-7244

Email: smorrissey@calderwoodharkness.com

Mr. Morrissey is the day-to-day contact for this matter and is authorized to receive and review all documentation related to this request on behalf of Penterra.

Penterra Pharmaceuticals Corp. (Client Contact — Insurance Matters):

Samantha Novak Director, Clinical Contracts Penterra Pharmaceuticals Corp. 200 Biopharma Boulevard, Suite 1400 Princeton, New Jersey 08540 Telephone: (609) 555-4120

Email: s.novak@penterrapharma.com

Penterra Pharmaceuticals Corp. (Client Contact — Legal):

Rebecca Liang, Esq. Associate General Counsel, Clinical Affairs Penterra Pharmaceuticals Corp. 200 Biopharma Boulevard, Suite 1400 Princeton, New Jersey 08540 Telephone: (609) 555-4085

Email: r.liang@penterrapharma.com

We ask that all correspondence and documentation relating to this request be directed to Mr. Morrissey at the address and email set forth above, with copies to Ms. Novak and Ms. Liang.

XI. CLOSING

We greatly appreciate Briarcliff's prompt attention to this request. The additional insured endorsement is essential to Penterra's satisfaction of its contractual obligations under the MCTA and to the timely commencement of the CLARION trial, which represents a significant milestone in the development of penterafenib for patients with advanced hepatocellular carcinoma. As noted above, we respectfully request that the endorsement and certificates be delivered no later than July 3, 2023.

Should Briarcliff require any additional information, documentation, or clarification in order to process this endorsement — including but not limited to copies of the full MCTA, the protocol synopsis, or additional corporate documentation for any of the named additional insureds — please do not hesitate to contact the undersigned or Mr. Morrissey at your earliest convenience. We are fully prepared to provide any supplementary materials on an expedited basis.

We look forward to Briarcliff's confirmation of receipt of this request and to the prompt issuance of the endorsement and certificates.

Very truly yours,

CALDERWOOD & HARKNESS LLP

By: ________

Miriam Calloway Partner 280 Park Avenue, 34th Floor New York, New York 10017 Telephone: (212) 549-7200

Email: mcalloway@calderwoodharkness.com

cc: Nathaniel Briggs, Esq., Vice President & General Counsel, Penterra Pharmaceuticals Corp. Rebecca Liang, Esq., Associate General Counsel, Clinical Affairs, Penterra Pharmaceuticals Corp. Samantha Novak, Director, Clinical Contracts, Penterra Pharmaceuticals Corp. Joel Strauss, Esq., Partner, Calderwood & Harkness LLP

Enclosures:

1. Schedule 1 — List of Participating Veridian Network Sites (38 sites across 14 states)

2. MCTA Exhibit E — Insurance Requirements and Certificate Forms (excerpt)

3. Form of Certificate of Insurance

Coverage Element	Current Policy Terms
Named Insured	Penterra Pharmaceuticals Corp.
Policy Number	BM-CTL-2023-04182
Policy Period	April 1, 2023 – March 31, 2024
Per-Occurrence Limit	$25,000,000
Aggregate Limit	$75,000,000
Subject-Injury Sublimit (Per Occurrence)	$10,000,000
Subject-Injury Sublimit (Aggregate)	$50,000,000

CALDERWOOD & HARKNESS LLP Attorneys at Law
280 Park Avenue, 34th Floor New York, New York 10017 Telephone: (212) 549-7000 Facsimile: (212) 549-7001
101 Carnegie Center, Suite 500 Princeton, New Jersey 08540 Telephone: (609) 452-8800 Facsimile: (609) 452-8801
www.calderwoodharkness.com
June 29, 2023
Via Email and Sundial Data Systems
Ms. Karen Tremblay Vice President, Life Sciences Lines Briarcliff Mutual Insurance Company 55 Constitution Plaza Hartford, CT 06103
Re: Request for Additional Insured Endorsement — Clinical Trial Liability Policy No. BM-CTL-2023-04182 Insured: Penterra Pharmaceuticals Corp. Policy Period: April 1, 2023 – March 31, 2024 Protocol: PPC-4871-III (CLARION Trial)
Dear Ms. Tremblay:
This firm represents Penterra Pharmaceuticals Corp. ("Penterra"), a Delaware corporation headquartered at 200 Biopharma Boulevard, Suite 1400, Princeton, New Jersey 08540, and publicly traded on the Nasdaq Global Select Market under the ticker symbol PTRA. We are writing on behalf of Penterra in connection with its clinical trial liability insurance policy issued by Briarcliff Mutual Insurance Company ("Briarcliff" or the "Company"), bearing Policy No. BM-CTL-2023-04182, with a current policy period of April 1, 2023 through March 31, 2024 (renewable annually) (the "Policy"). The purpose of this letter is to formally request that Briarcliff endorse the Policy to add certain parties as additional insureds in connection with a Phase III clinical trial that Penterra is sponsoring, as more fully described below. Given the contractual deadlines governing this matter, we respectfully request Briarcliff's expedited attention to this request.
I. BACKGROUND — THE CLARION TRIAL
Penterra is the sponsor of Protocol PPC-4871-III, a pivotal Phase III clinical trial titled "CLARION — Clinical Assessment of Response with Longitudinal Investigation in ONcology." The CLARION trial is designed to evaluate the safety and efficacy of penterafenib (PPC-4871), an oral multi-kinase inhibitor, in patients with advanced hepatocellular carcinoma ("HCC") who have experienced disease progression following at least one prior line of systemic therapy in the second-line setting.
The CLARION trial is a randomized, double-blind, placebo-controlled, multi-center study conducted under Investigational New Drug Application No. IND 157823, on file with the United States Food and Drug Administration, Center for Drug Evaluation and Research. The study is registered on the ClinicalTrials.gov database under Identifier No. NCT05928174.
The trial design calls for planned enrollment of approximately 1,200 subjects, randomized in a 2:1 ratio (penterafenib to placebo), yielding approximately 800 subjects in the active treatment arm and approximately 400 subjects in the placebo control arm. The projected enrollment period is 42 months from first patient in, with a target first-patient-in date of August 14, 2023. The estimated total study duration, inclusive of the enrollment period and an 18-month post-enrollment follow-up period, is approximately 60 months.
The CLARION trial represents a critical regulatory milestone for Penterra's lead oncology pipeline candidate and, upon successful completion, is expected to support a New Drug Application submission to the FDA for the penterafenib HCC indication.
II. BACKGROUND — MASTER CLINICAL TRIAL AGREEMENT WITH VERIDIAN
On June 28, 2023, Penterra executed a Master Clinical Trial Agreement (the "MCTA") with Veridian Health Research Network, Inc. ("Veridian"), a Delaware corporation organized as a tax-exempt entity under Section 501(c)(3) of the Internal Revenue Code (EIN: 23-4178205), with its principal offices located at 750 Research Parkway, 8th Floor, Philadelphia, Pennsylvania 19104. Veridian operates a nationally recognized network of 38 academic medical centers and affiliated research institutions spanning 14 states, and serves as the coordinating site network organization for the CLARION trial.
The MCTA governs the overall clinical research relationship between Penterra and Veridian in connection with the conduct of the CLARION trial across the Veridian Network. The MCTA has a total estimated deal value of approximately $80,000,000, encompassing site fees, per-patient payments, investigator grants, monitoring and operational costs, and related expenditures over the projected life of the trial.
Critically, the MCTA imposes certain insurance obligations on Penterra. Specifically:
(a) Minimum Limits. Under Section 14.1 of the MCTA, Penterra is required to maintain clinical trial liability insurance with minimum limits of not less than $25,000,000 per occurrence and $75,000,000 in the aggregate for the duration of the trial and for a reasonable period thereafter.
(b) Additional Insured Requirement. Under Section 14.2 of the MCTA, Penterra is required to name Veridian and each participating Veridian Network site institution, together with their respective officers, directors, employees, agents, principal investigators, sub-investigators, and research staff (collectively, the "Site Personnel"), as additional insureds under Penterra's clinical trial liability policy, with respect to claims arising out of or related to the conduct of the CLARION trial.
(c) Certificate Delivery Deadline. Under Section 14.3 of the MCTA, certificates of insurance evidencing such additional insured status must be delivered to Veridian no later than 15 business days following the date of execution of the MCTA — that is, by approximately July 20, 2023. However, the delivery of satisfactory insurance certificates is also a condition precedent to the closing of the MCTA, which is scheduled for July 5, 2023, as set forth in Section 3.2 of the MCTA.
(d) Tail Coverage. Under Section 14.4 of the MCTA, Penterra's insurance must remain in effect throughout the duration of the trial and for a reasonable period thereafter, consistent with the applicable statute of limitations for personal injury claims in the jurisdictions where participating sites are located.
We enclose herewith, for Briarcliff's reference, relevant excerpts from MCTA Exhibit E (Insurance Requirements and Certificate Forms), which sets forth in detail the insurance specifications required under the agreement.
III. CURRENT POLICY COVERAGE SUMMARY
For ease of reference, we summarize below the current terms of Policy No. BM-CTL-2023-04182 as they pertain to this request:
We understand that the Policy's existing terms, including the limits of liability set forth above, satisfy the minimum insurance requirements under Section 14.1 of the MCTA. The present request concerns solely the addition of the parties identified below as additional insureds under the Policy, and is not a request to modify the limits of liability or other substantive coverage terms.
IV. FORMAL REQUEST FOR ADDITIONAL INSURED ENDORSEMENT
Penterra hereby requests that Briarcliff endorse Policy No. BM-CTL-2023-04182 to name the following parties as additional insureds under the Policy, effective as of the date of issuance of the endorsement:
A. Primary Additional Insured — Veridian Health Research Network, Inc.
Full Legal Name: Veridian Health Research Network, Inc.
Address: 750 Research Parkway, 8th Floor, Philadelphia, Pennsylvania 19104
Entity Type: Delaware corporation, tax-exempt under Section 501(c)(3) of the Internal Revenue Code
Role: Site network counterparty under the MCTA; coordinating organization for all 38 participating clinical trial sites in the Veridian Network
Veridian serves as the central contracting entity for the Veridian Network and bears primary responsibility for the operational coordination and oversight of the participating sites conducting the CLARION trial. As the counterparty to the MCTA, Veridian has a direct contractual relationship with Penterra and is the first-named beneficiary of the additional insured requirement set forth in Section 14.2 of the agreement.
B. Additional Insureds — Participating Veridian Network Site Institutions
Penterra further requests that each of the 38 participating Veridian Network site institutions across 14 states be added as additional insureds under the Policy. Coverage should extend to each site institution as an entity, and should also extend to such institution's officers, directors, employees, agents, principal investigators, sub-investigators, study coordinators, pharmacists, nurses, and other research staff acting within the scope of their duties in connection with the conduct of the CLARION trial.
A complete listing of all 38 participating sites, including site numbers, full institutional names, addresses, and state of organization, is set forth in the enclosed Schedule 1 — List of Participating Veridian Network Sites, which is attached hereto and incorporated by reference into this request.
For Briarcliff's immediate reference, we identify below the five designated lead sites under the MCTA:
Site 001 — Graystone University Medical Center 1200 University Avenue, Philadelphia, Pennsylvania 19104 Pennsylvania nonprofit corporation Principal Investigator: Catherine Aldridge, M.D., Ph.D. (Dr. Aldridge serves as Global Principal Investigator for the CLARION trial)
Site 002 — Lakemont Medical Center 4400 North Michigan Drive, Chicago, Illinois 60611 Illinois nonprofit corporation Co-Principal Investigator: Howard Matsuoka, M.D.
Site 003 — Haverford Regional Medical Center Boston, Massachusetts (Full address set forth in Schedule 1)
Site 004 — Cedar Falls University Hospital Denver, Colorado (Full address set forth in Schedule 1)
Site 005 — Weston Memorial Health System Atlanta, Georgia (Full address set forth in Schedule 1)
The remaining 33 participating sites are identified in full detail on the enclosed Schedule 1.
C. Mechanism for Adding Future Sites
We note that additional sites may be activated during the projected 42-month enrollment period as new institutions execute Individual Site Agreements (in the form of joinder agreements) under the MCTA framework. Penterra respectfully requests that Briarcliff provide a mechanism — whether by means of a blanket endorsement covering all Veridian Network institutions that execute joinders under the MCTA, or alternatively through an expedited amendment or endorsement process — for the addition of such future sites as additional insureds as they are activated throughout the enrollment period. A blanket endorsement covering all current and future Veridian Network participating sites would be the most administratively efficient approach and would best serve the needs of the parties. We are, however, prepared to discuss alternative arrangements that Briarcliff may prefer.
V. SCOPE OF ADDITIONAL INSURED COVERAGE REQUESTED
The additional insured endorsement should provide coverage to the above-named additional insureds with respect to claims arising out of or related to the following:
(a) Bodily injury, personal injury, or death of a trial subject caused by the investigational product (penterafenib / PPC-4871) when administered in accordance with the protocol for Protocol PPC-4871-III, including but not limited to adverse drug reactions, adverse events, serious adverse events, and suspected unexpected serious adverse reactions;
(b) Any defect in the design, manufacture, formulation, labeling, packaging, storage, or supply of the investigational product, including any failure of the investigational product to conform to applicable specifications, or any contamination, adulteration, or mislabeling thereof;
(c) Penterra's indemnification obligations under the MCTA, including without limitation the subject-injury indemnification provisions set forth in MCTA Exhibit D, and any defense and hold-harmless obligations owed by Penterra to Veridian, the participating sites, and Site Personnel under Sections 12.1 through 12.4 of the MCTA;
(d) Activities performed by the additional insureds, their officers, directors, employees, agents, principal investigators, sub-investigators, and research staff in connection with the conduct of the CLARION trial, to the extent such activities are performed within the scope of the protocol and the MCTA; and
(e) Any regulatory or governmental investigation, proceeding, or enforcement action arising out of or related to the conduct of the CLARION trial, to the extent such matters are covered under the terms and conditions of the Policy.
In addition, Penterra requests that the additional insured coverage be endorsed as primary and non-contributory with respect to any insurance maintained by the additional insureds themselves, including without limitation any institutional professional liability, general liability, or umbrella/excess liability coverage maintained by Veridian or any participating site institution. The additional insureds' own insurance, if any, should apply as excess over and non-contributory with the coverage afforded under the Policy.
Penterra further requests a waiver of subrogation in favor of all additional insureds, to the extent permitted under the terms and conditions of the Policy and applicable law. This waiver of subrogation is consistent with the mutual waiver provisions set forth in Section 12.5 of the MCTA and is essential to the harmonious allocation of risk among the parties to the clinical trial.
VI. CONSISTENCY WITH MCTA INDEMNIFICATION AND INSURANCE PROVISIONS
The additional insured endorsement requested herein is intended to be consistent with, and supportive of, Penterra's contractual indemnification obligations under the MCTA. For Briarcliff's reference, we summarize the key indemnification provisions below:
(a) Under MCTA Exhibit D (Subject-Injury Indemnification Provisions), Penterra has agreed to indemnify, defend, and hold harmless Veridian, each participating site institution, and each institution's Site Personnel from and against any and all claims, losses, damages, liabilities, costs, and expenses (including reasonable attorneys' fees) arising out of or resulting from: (i) product-related subject injury, including injury attributable to the investigational product or its administration in accordance with the protocol; (ii) any defect in the investigational product; and (iii) Penterra's negligence or willful misconduct in connection with the trial.
(b) MCTA Exhibit D establishes a per-subject cap on subject-injury medical care costs of $500,000 per individual subject, and an aggregate cap of $15,000,000 on all subject-injury medical care costs across all subjects enrolled in the trial. These caps relate to Penterra's direct medical cost reimbursement obligations and do not limit Penterra's broader indemnification obligations for claims and liabilities.
(c) Under MCTA Exhibit E (Insurance Requirements and Certificate Forms), the insurance maintained by Penterra must (i) name Veridian and each participating site as additional insureds, (ii) be primary and non-contributory, (iii) include a waiver of subrogation in favor of the additional insureds, (iv) provide for 30 days' prior written notice to additional insureds of cancellation or material modification, and (v) remain in effect throughout the trial and for a reasonable period thereafter.
The additional insured endorsement should be structured so as to align with, and provide insurance support for, the foregoing contractual obligations. We enclose herewith the relevant excerpts from MCTA Exhibit E for Briarcliff's review and reference in preparing the endorsement.
VII. REQUESTED DELIVERABLES
Penterra respectfully requests that Briarcliff prepare and deliver the following documents to Calderwood & Harkness at the address set forth above:
1. Endorsement. A formal endorsement to Policy No. BM-CTL-2023-04182 reflecting the additional insured status of Veridian Health Research Network, Inc. and each of the 38 participating Veridian Network site institutions (and their respective officers, directors, employees, agents, and Site Personnel), as described in Sections IV and V above.
2. Updated Certificate(s) of Insurance. Updated certificate(s) of insurance, in a form acceptable under Exhibit E of the MCTA, reflecting the following:
(a) The names of all additional insureds, including Veridian and each participating site institution;
(b) The Policy number (BM-CTL-2023-04182), the per-occurrence limit ($25,000,000), the aggregate limit ($75,000,000), and the subject-injury sublimit ($10,000,000 per occurrence / $50,000,000 aggregate);
(c) A specific reference to the additional insured endorsement, including its effective date and endorsement number;
(d) A notation that the additional insured coverage is primary and non-contributory;
(e) A notation that the Policy includes a waiver of subrogation in favor of the additional insureds; and
(f) A statement that the Company will provide no less than 30 days' prior written notice to each additional insured (or to Veridian on behalf of all additional insureds) in the event of cancellation, non-renewal, or material modification of the Policy.
3. Multiple Copies. Multiple original copies of the certificates of insurance for distribution to Veridian and to each individual participating site institution. We anticipate requiring at least 40 original certificates — one for Veridian's master file and one for each of the 38 participating sites, plus one additional copy for Penterra's records.
4. Conformity with MCTA Requirements. We request that all certificates be issued in a form acceptable under Exhibit E of the MCTA, a copy of which is enclosed herewith for Briarcliff's reference. To the extent that Briarcliff's standard certificate form differs in any material respect from the form required under Exhibit E, we ask that Briarcliff advise us promptly so that we may coordinate with Veridian's counsel to resolve any discrepancies.
VIII. TIMING AND URGENCY
We wish to emphasize the time-sensitive nature of this request. As noted above, the MCTA requires delivery of insurance certificates evidencing additional insured status within 15 business days of execution (i.e., by approximately July 20, 2023). However, the delivery of satisfactory insurance certificates and evidence of the additional insured endorsement is also a condition precedent to the closing of the MCTA, which is scheduled for July 5, 2023. Failure to deliver the required insurance documentation by the closing date could result in a delay to the closing, a delay to the commencement of the CLARION trial, and potential contractual consequences for Penterra under the MCTA.
Accordingly, Penterra respectfully requests that Briarcliff process the endorsement and issue the requested certificates on an expedited basis, with delivery to Calderwood & Harkness no later than July 3, 2023, in order to allow sufficient time for our review and for timely delivery to Veridian's counsel, Whitmore, Jansen & Callahan LLP, at 1500 Market Street, Suite 3200, Philadelphia, Pennsylvania 19102, in advance of the July 5, 2023 closing date.
We recognize that this is an accelerated timeline and appreciate Briarcliff's willingness to accommodate this request. If Briarcliff anticipates any difficulty in meeting this deadline, we ask that you contact the undersigned immediately so that we may discuss alternative arrangements.
IX. PREMIUM AND BILLING
We understand that the addition of additional insureds to the Policy may result in an additional premium charge or endorsement fee. Penterra requests that Briarcliff provide a premium quotation or invoice for any such additional charges, directed to the attention of:
Ms. Samantha Novak Director, Clinical Contracts Penterra Pharmaceuticals Corp. 200 Biopharma Boulevard, Suite 1400 Princeton, New Jersey 08540 Telephone: (609) 555-4120
Email: s.novak@penterrapharma.com
Penterra is prepared to remit any additional premium or endorsement fee promptly upon receipt of Briarcliff's invoice. If Briarcliff requires advance payment of additional premium as a condition to issuing the endorsement, please advise us immediately so that payment can be arranged without delay.
X. CONTACT INFORMATION FOR COORDINATION
For purposes of coordinating the preparation and delivery of the endorsement and certificates, the following individuals should serve as points of contact:
Calderwood & Harkness LLP (Outside Counsel):
Sean Morrissey, Esq. Associate, Healthcare & Life Sciences Practice Group Calderwood & Harkness LLP 280 Park Avenue, 34th Floor New York, New York 10017 Telephone: (212) 549-7244
Email: smorrissey@calderwoodharkness.com
Mr. Morrissey is the day-to-day contact for this matter and is authorized to receive and review all documentation related to this request on behalf of Penterra.
Penterra Pharmaceuticals Corp. (Client Contact — Insurance Matters):
Samantha Novak Director, Clinical Contracts Penterra Pharmaceuticals Corp. 200 Biopharma Boulevard, Suite 1400 Princeton, New Jersey 08540 Telephone: (609) 555-4120
Email: s.novak@penterrapharma.com
Penterra Pharmaceuticals Corp. (Client Contact — Legal):
Rebecca Liang, Esq. Associate General Counsel, Clinical Affairs Penterra Pharmaceuticals Corp. 200 Biopharma Boulevard, Suite 1400 Princeton, New Jersey 08540 Telephone: (609) 555-4085
Email: r.liang@penterrapharma.com
We ask that all correspondence and documentation relating to this request be directed to Mr. Morrissey at the address and email set forth above, with copies to Ms. Novak and Ms. Liang.
XI. CLOSING
We greatly appreciate Briarcliff's prompt attention to this request. The additional insured endorsement is essential to Penterra's satisfaction of its contractual obligations under the MCTA and to the timely commencement of the CLARION trial, which represents a significant milestone in the development of penterafenib for patients with advanced hepatocellular carcinoma. As noted above, we respectfully request that the endorsement and certificates be delivered no later than July 3, 2023.
Should Briarcliff require any additional information, documentation, or clarification in order to process this endorsement — including but not limited to copies of the full MCTA, the protocol synopsis, or additional corporate documentation for any of the named additional insureds — please do not hesitate to contact the undersigned or Mr. Morrissey at your earliest convenience. We are fully prepared to provide any supplementary materials on an expedited basis.
We look forward to Briarcliff's confirmation of receipt of this request and to the prompt issuance of the endorsement and certificates.
Very truly yours,
CALDERWOOD & HARKNESS LLP
By: ________
Miriam Calloway Partner 280 Park Avenue, 34th Floor New York, New York 10017 Telephone: (212) 549-7200
Email: mcalloway@calderwoodharkness.com
cc: Nathaniel Briggs, Esq., Vice President & General Counsel, Penterra Pharmaceuticals Corp. Rebecca Liang, Esq., Associate General Counsel, Clinical Affairs, Penterra Pharmaceuticals Corp. Samantha Novak, Director, Clinical Contracts, Penterra Pharmaceuticals Corp. Joel Strauss, Esq., Partner, Calderwood & Harkness LLP
Enclosures:
1. Schedule 1 — List of Participating Veridian Network Sites (38 sites across 14 states)
2. MCTA Exhibit E — Insurance Requirements and Certificate Forms (excerpt)
3. Form of Certificate of Insurance
Coverage Element | Current Policy Terms
Named Insured | Penterra Pharmaceuticals Corp.
Policy Number | BM-CTL-2023-04182
Policy Period | April 1, 2023 – March 31, 2024
Per-Occurrence Limit | $25,000,000
Aggregate Limit | $75,000,000
Subject-Injury Sublimit (Per Occurrence) | $10,000,000
Subject-Injury Sublimit (Aggregate) | $50,000,000