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Contract analysis / letter-briarcliff-additional-insured.docx
letter-briarcliff-additional-insured.docx
1018-00004 · 18 clauses
High · 2 Medium · 1 Standard · 2
I. BACKGROUND — THE CLARION TRIAL
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
II. BACKGROUND — MASTER CLINICAL TRIAL AGREEMENT WITH VERIDIAN Standard
⚑ Commercial term
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, Pen
III. CURRENT POLICY COVERAGE SUMMARY
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
IV. FORMAL REQUEST FOR ADDITIONAL INSURED ENDORSEMENT
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, 8t
V. SCOPE OF ADDITIONAL INSURED COVERAGE REQUESTED High
⚑ Indemnity / guarantee obligation
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,
VI. CONSISTENCY WITH MCTA INDEMNIFICATION AND INSURANCE PROVISIONS High
⚑ Indemnity / guarantee obligation
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 inde
VII. REQUESTED DELIVERABLES
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 addit
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 ac
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 pe
3. Multiple Copies. Multiple original copies of the certificates of insurance for distrib
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 for
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
VIII. TIMING AND URGENCY
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
IX. PREMIUM AND BILLING Standard
⚑ Commercial term
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, Ne
X. CONTACT INFORMATION FOR COORDINATION
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
XI. CLOSING Medium
⚑ Liability cap to check against exposure
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 requ
1. Schedule 1 — List of Participating Veridian Network Sites (38 sites across 14 states)
1. Schedule 1 — List of Participating Veridian Network Sites (38 sites across 14 states)
2. MCTA Exhibit E — Insurance Requirements and Certificate Forms (excerpt)
2. MCTA Exhibit E — Insurance Requirements and Certificate Forms (excerpt)
3. Form of Certificate of Insurance
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