FR EA
1018-00004 · Penterra Pharmaceuticals Corp · Insurance
letter-veridian-insurance-request.docx DOCUMENT Finance & Banking
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CALDERWOOD & HARKNESS LLP

Attorneys at Law

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

Telephone: (212) 554-7000 Facsimile: (212) 554-7001

Princeton Office: 101 Carnegie Center, Suite 500, Princeton, NJ 08540

July 3, 2023

Via Email and Sundial Data Systems

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

Re: Master Clinical Trial Agreement dated June 28, 2023, by and between Penterra Pharmaceuticals Corp. and Veridian Health Research Network, Inc. — Protocol PPC-4871-III (CLARION); Request for Site Insurance Certificates

Dear Mr. Callahan:

We write on behalf of our client, Penterra Pharmaceuticals Corp. ("Penterra" or "Sponsor"), in connection with the Master Clinical Trial Agreement dated June 28, 2023 (the "MCTA"), by and between Penterra and Veridian Health Research Network, Inc. ("Veridian"), governing the conduct of the Phase III clinical trial under Protocol PPC-4871-III, known as CLARION (Clinical Assessment of Response with Longitudinal Investigation in ONcology). As you are aware, Calderwood & Harkness LLP serves as outside counsel to Penterra with respect to all matters arising under the MCTA, including the implementation of the insurance and risk management provisions set forth therein. The purpose of this letter is to formally request, on Penterra's behalf, the timely delivery of certificates of insurance from each of the participating Veridian Network site institutions, as required under the terms and conditions of the MCTA.

As set forth in Section 12.3 of the MCTA and further detailed in Exhibit E (Insurance Requirements and Certificate Forms) attached thereto, Veridian and each participating site institution within the Veridian Network are required to procure and maintain, at their own cost and expense, throughout the term of the MCTA and for a reasonable period thereafter, general liability insurance and professional liability (errors and omissions) insurance covering all activities performed in connection with the CLARION trial. Exhibit E specifies the following minimum coverage levels, which must be reflected in each certificate of insurance:

(a) General liability and professional liability (errors and omissions) coverage with a minimum limit of not less than $5,000,000 per occurrence; and

(b) An aggregate limit of not less than $10,000,000.

Such coverage must have been in effect no later than the MCTA execution date of June 28, 2023, and must remain continuously in force for the duration of the trial, including through the projected study completion date, which, based on the 42-month enrollment period and 18-month follow-up period specified in the protocol, is currently estimated to be August 2028. We note that these requirements apply to each and every participating site institution, without exception, regardless of that site's anticipated enrollment volume or the nature of its institutional insurance program.

Pursuant to Section 12.3(c) of the MCTA, certificates of insurance evidencing the foregoing coverage must be delivered to Penterra within fifteen (15) business days following the execution date of the MCTA. Given that the MCTA was fully executed on June 28, 2023, the contractual deadline for delivery of all site insurance certificates falls on Thursday, July 20, 2023. We are providing this request in advance of that deadline so as to afford Veridian and each participating site institution the maximum time available to compile and transmit the required documentation. We wish to emphasize that the timely delivery of insurance certificates is a condition precedent to the satisfaction of certain closing conditions under the MCTA, with the closing date set for July 5, 2023, and the effective date set for July 18, 2023. While Penterra recognizes that the closing date may, as a practical matter, precede the full collection of all thirty-eight (38) site certificates, Penterra regards the completion of delivery by the contractual deadline of July 20, 2023, as a material obligation of Veridian under the MCTA, and reserves all rights and remedies in connection therewith.

Penterra respectfully requests that Veridian deliver certificates of insurance for each of the thirty-eight (38) Veridian Network participating site institutions located across fourteen (14) states, as identified on Schedule 1 to the MCTA (List of Participating Veridian Network Sites). Given the operational priorities associated with site activation timelines and the first-patient-in milestone, we request that Veridian prioritize delivery of certificates for the following lead sites:

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

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

(iii) Haverford Regional Medical Center (Site 003), Boston, MA;

(iv) Cedar Falls University Hospital (Site 004), Denver, CO; and

(v) Weston Memorial Health System (Site 005), Atlanta, GA.

As Graystone University Medical Center and Lakemont Medical Center have been designated as the lead enrollment sites for the CLARION trial, we ask that certificates for those two institutions be delivered as promptly as possible — and, in any event, no later than July 12, 2023 — given the target first patient in date of August 14, 2023, and the site activation and readiness activities that must be completed in advance of that milestone. For the remaining thirty-three (33) sites, delivery by the July 20, 2023, contractual deadline will be satisfactory.

Each certificate of insurance must contain, at a minimum, the following information, consistent with the form and requirements set forth in Exhibit E to the MCTA:

(a) The full legal name of the insured site institution;

(b) The name and address of the insurance carrier(s) providing coverage;

(c) The applicable policy number(s);

(d) The policy period, including inception and expiration dates;

(e) The type(s) of coverage afforded under the policy, including, without limitation, general liability and professional liability (errors and omissions) coverage;

(f) The per-occurrence limit, which must be no less than $5,000,000;

(g) The aggregate limit, which must be no less than $10,000,000;

(h) Confirmation that Penterra Pharmaceuticals Corp. has been named as an additional insured under the policy or, alternatively, that the policy otherwise covers Penterra's interests as Sponsor under the MCTA, as applicable under the terms of Exhibit E;

(i) A statement that the insurer will provide at least thirty (30) days' prior written notice to Penterra in the event of cancellation, non-renewal, or material modification of the policy; and

(j) Such other information as may be required to conform the certificate to the form set forth in Exhibit E to the MCTA.

We ask that Veridian instruct each participating site institution to ensure that its certificate of insurance conforms in all respects to the template form attached as Appendix 1 to Exhibit E, so as to facilitate Penterra's internal review and minimize any need for follow-up requests or reissuances.

In addition, we wish to remind Veridian that under Section 12.3(d) of the MCTA, updated certificates of insurance must be provided annually for each site institution for the duration of the CLARION trial. Given the projected total study duration of approximately sixty (60) months — encompassing the 42-month enrollment period and the 18-month follow-up period — insurance must be maintained continuously through the projected study completion date of August 2028. Penterra respectfully requests that Veridian establish an internal process and calendar for the annual collection and forwarding of renewed certificates of insurance from each participating site institution, so that there is no lapse in documentation of required coverage over the multi-year course of the trial. Penterra's Clinical Contracts group, under the direction of Samantha Novak, will maintain a tracking log of all site certificates and renewal dates and will follow up in advance of each annual renewal period; however, the obligation to deliver updated certificates rests with Veridian and the participating sites under the terms of the MCTA.

For completeness, we wish to note that Penterra is concurrently delivering its own certificate of insurance from Briarcliff Mutual Insurance Company (Policy No. BM-CTL-2023-04182), demonstrating clinical trial liability coverage with limits of $25,000,000 per occurrence and $75,000,000 in the aggregate, together with a subject-injury sublimit of $10,000,000 per occurrence and $50,000,000 in the aggregate. The Penterra certificate, including the additional insured endorsement naming Veridian Health Research Network, Inc. and each participating site institution as additional insureds, is being transmitted separately to Whitmore, Jansen & Callahan LLP under cover of a separate transmittal letter dated as of the date hereof. The Briarcliff policy period runs from April 1, 2023, through March 31, 2024, and is renewable annually thereafter. Penterra will provide an updated certificate upon each annual renewal of the Briarcliff policy for the duration of the MCTA.

We wish to underscore that the delivery of compliant site insurance certificates is a material obligation under the MCTA, and that Penterra's clinical operations team will not authorize site activation or the commencement of patient enrollment at any given participating site until Penterra has received and reviewed a certificate of insurance for that site that meets the requirements of Exhibit E. We ask for Veridian's full cooperation in ensuring timely compliance with this obligation so as to avoid any delay in site activation or any adverse impact on the target first patient in date of August 14, 2023. Any delay in the delivery of site certificates could have downstream consequences for the trial's enrollment timeline and, ultimately, for the overall study schedule.

Penterra requests that all certificates of insurance be delivered to Calderwood & Harkness LLP at the following address, to the attention of Sean Morrissey:

Sean Morrissey, Associate Calderwood & Harkness LLP 280 Park Avenue, 34th Floor New York, NY 10017

In addition to hard-copy delivery, Penterra requests that electronic copies (in PDF format) of all certificates be transmitted via email to each of the following recipients:

Sean Morrissey — smorrissey@calderwoodharkness.com Christopher Aiken — caiken@calderwoodharkness.com Rebecca Liang, Esq. — rebecca.liang@penterra.com Samantha Novak — samantha.novak@penterra.com

On behalf of Penterra, we wish to thank you and the entire Veridian team for your cooperation and professionalism throughout the MCTA negotiation process. We look forward to a productive collaboration on the CLARION trial. Should you have any questions regarding the insurance requirements, the certificate format, or any other aspect of this request, please do not hesitate to contact me directly at (212) 554-7244 or by email at mcalloway@calderwoodharkness.com. Calderwood & Harkness also remains available to coordinate directly with Allison Whitmore and her team at Whitmore, Jansen & Callahan LLP on any insurance-related matters, and we encourage open communication among counsel to facilitate the efficient resolution of any issues that may arise in the course of collecting and reviewing the site certificates.

We appreciate your prompt attention to this matter.

Very truly yours,

CALDERWOOD & HARKNESS LLP

By: ________

Miriam Calloway Partner Healthcare & Life Sciences Practice Group

Encl.: Schedule 1 to MCTA — List of Participating Veridian Network Sites (38 Sites) (for reference)

cc:

Allison Whitmore, Esq., Whitmore, Jansen & Callahan LLP, 1500 Market Street, Suite 3200, Philadelphia, PA 19102

Patricia Dunne, Director, Sponsored Research Agreements, Veridian Health Research Network, Inc.

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

Samantha Novak, Director, Clinical Contracts, Penterra Pharmaceuticals Corp.

Sean Morrissey, Calderwood & Harkness LLP

Christopher Aiken, Calderwood & Harkness LLP