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EXHIBIT D

Subject-Injury Indemnification Provisions

This Exhibit D (these "Indemnification Provisions") is attached to and incorporated by reference into the Master Clinical Trial Agreement dated June 28, 2023 (the "Agreement" or "MCTA"), by and between:

Penterra Pharmaceuticals Corp., a corporation organized and existing under the laws of the State of Delaware, with its principal offices located at 200 Biopharma Boulevard, Suite 1400, Princeton, New Jersey 08540 ("Sponsor" or "Penterra");

and

Veridian Health Research Network, Inc., a nonprofit corporation organized and existing under the laws of the State of Delaware and recognized as tax-exempt under Section 501(c)(3) of the Internal Revenue Code, with its principal offices located at 750 Research Parkway, 8th Floor, Philadelphia, Pennsylvania 19104 ("Site Network" or "Veridian").

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 herein shall have the meanings ascribed to them in the Agreement. In the event of any conflict between the terms of this Exhibit D and the terms of the Agreement, the terms of this Exhibit D shall govern with respect to the subject matter addressed herein, unless the Agreement expressly provides otherwise.

Section 1: Definitions

For purposes of this Exhibit D, the following terms shall have the meanings set forth below:

1.1 "Claim" shall mean any demand, action, suit, proceeding (whether at law, in equity, or before any administrative or regulatory body), investigation, or claim by a third party (including, without limitation, a Study Subject, any estate or personal representative of a Study Subject, any family member of a Study Subject, or any legal representative of any of the foregoing) asserted against an Indemnified Party, whether such demand, action, suit, proceeding, investigation, or claim is formal or informal, written or oral, and regardless of whether it is brought in a court of competent jurisdiction, before an arbitral tribunal, before a regulatory agency, or otherwise. A Claim shall include, without limitation, claims sounding in tort, contract, strict liability, products liability, medical malpractice, fraud, breach of fiduciary duty, violation of statute, or any other legal theory.

1.2 "Indemnified Losses" shall mean all claims, losses, damages (including compensatory, consequential, incidental, special, and punitive damages to the extent awarded by a court or arbitral panel of competent jurisdiction), liabilities, judgments, settlements, penalties, fines, costs, and expenses (including, without limitation, reasonable attorneys' fees, expert witness fees, court costs, costs of investigation, and costs of appeal) arising from, relating to, or in connection with a Claim. For the avoidance of doubt, Indemnified Losses shall include all out-of-pocket costs and expenses reasonably incurred by the Indemnified Party in cooperating with the investigation, defense, or resolution of a Claim, as well as any amounts paid in settlement of a Claim in accordance with the procedures set forth in Section 7 hereof.

1.3 "Investigator" shall mean each principal investigator, co-principal investigator, and sub-investigator identified on the applicable Form FDA 1572 (Statement of Investigator) for each Participating Site, as such Form FDA 1572 may be amended or supplemented from time to time during the course of the CLARION trial. As of the Effective Date of the Agreement, the Investigators include, without limitation, Dr. Catherine Aldridge, M.D., Ph.D. (Global Principal Investigator, Graystone University Medical Center, Philadelphia, Pennsylvania) and Dr. Howard Matsuoka, M.D. (Co-Principal Investigator, Lakemont Medical Center, Rochester, Minnesota). Additional Investigators may be added or removed during the course of the CLARION trial in accordance with the Protocol and applicable regulatory requirements, and such additions or removals shall not require an amendment to this Exhibit D.

1.4 "Participating Site" shall mean each academic medical center, hospital, research institution, or clinical facility within the Veridian Health Research Network that is listed on Schedule 1 to the Agreement and that has executed an Individual Site Agreement (Joinder) under Exhibit C to the Agreement, thereby agreeing to conduct the CLARION trial in accordance with the Protocol and the terms of the Agreement. As of the Effective Date of the Agreement, there are thirty-eight (38) Participating Sites located across fourteen (14) states within the United States. Each Participating Site shall be deemed a party to this Exhibit D by virtue of its execution of the applicable Individual Site Agreement (Joinder), which incorporates the terms of this Exhibit D by reference.

1.5 "Protocol" shall mean Protocol PPC-4871-III, titled "Clinical Assessment of Response with Longitudinal Investigation in ONcology (CLARION): A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Penterafenib (PPC-4871) in Adult Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring BRAF V600E Mutations," as may be amended from time to time with the approval of the U.S. Food and Drug Administration ("FDA") and the applicable Institutional Review Board(s) ("IRB(s)"), including all protocol amendments, addenda, and clarification letters issued by Sponsor.

1.6 "Site Indemnified Parties" shall mean, collectively: (a) Veridian Health Research Network, Inc.; (b) each Participating Site (including, without limitation, Graystone University Medical Center and Lakemont Medical Center); (c) each Investigator; (d) each sub-investigator; (e) each study coordinator, research nurse, clinical research associate, data entry specialist, pharmacist, and other site personnel acting within the scope of their duties under the Protocol and this Agreement; (f) the officers, directors, trustees, employees, agents, and volunteers of each of the foregoing entities; and (g) the respective successors and assigns of each of the foregoing. For the avoidance of doubt, Site Indemnified Parties shall include all personnel identified on the delegation of authority log maintained at each Participating Site pursuant to the Protocol.

1.7 "Sponsor Indemnified Parties" shall mean, collectively: (a) Penterra Pharmaceuticals Corp.; (b) its officers, directors, employees, agents, and representatives; (c) its parent companies, subsidiaries, and affiliates; and (d) the respective successors and assigns of each of the foregoing.

1.8 "Study Subject" shall mean each individual who has been enrolled and randomized in the CLARION trial pursuant to the Protocol, including individuals who have signed an informed consent form approved by the applicable IRB and who have been assigned a randomization number. The planned enrollment for the CLARION trial is approximately 1,200 Study Subjects, randomized in a 2:1 ratio (penterafenib:placebo). For purposes of this Exhibit D, a "Study Subject" shall include any individual who receives any dose of the Investigational Product or placebo, regardless of whether such individual completes the full course of treatment contemplated by the Protocol.

1.9 "Study-Related Injury" shall mean any bodily injury, illness, disease, adverse health consequence, disability, or death sustained by a Study Subject that is caused by or directly results from: (a) the administration of the Investigational Product (PPC-4871), whether active drug or matching placebo, in connection with the CLARION trial; (b) any study procedure, examination, test, assessment, or intervention required by or performed pursuant to the Protocol, including but not limited to blood draws, biopsies, imaging studies, electrocardiograms, pharmacokinetic sampling, and any other diagnostic or therapeutic procedure mandated by the Protocol that would not otherwise be performed as part of the Study Subject's standard medical care; or (c) any defect in the design, manufacture, formulation, packaging, labeling, storage, or handling of the Investigational Product that is attributable to Sponsor or its agents. A Study-Related Injury shall not include the progression of the Study Subject's underlying disease (i.e., non-small cell lung cancer) unless such progression is proximately caused by a Product Defect or the negligent administration of the Investigational Product.

1.10 "Product Defect" shall mean any defect in the design, manufacture, formulation, compounding, packaging, labeling, storage, handling, or distribution of PPC-4871 (including matching placebo) that is attributable to Sponsor or any of its agents, contractors, subcontractors, or designees, including without limitation Meridian Contract Research Organization, Inc. ("Meridian CRO"), Northbridge Bioanalytical Laboratories, Inc. ("Northbridge"), or any other Sponsor-designated contract manufacturer, contract research organization, central laboratory, or logistics provider engaged by Sponsor in connection with the CLARION trial. A Product Defect shall include, without limitation: (i) contamination or adulteration of the Investigational Product; (ii) failure of the Investigational Product to meet its approved specifications or certificate of analysis; (iii) errors in labeling, packaging, or coding (including randomization code errors); (iv) failure to maintain required storage conditions during transport or distribution prior to delivery to the Participating Site; and (v) any inherent design defect in the molecular entity that renders PPC-4871 unreasonably dangerous when used as directed in the Protocol.

1.11 "Medically Necessary Protocol Deviation" shall mean a departure from the Protocol undertaken by an Investigator in good faith and in the exercise of reasonable medical judgment to protect the life, safety, or welfare of a Study Subject, where the Investigator reasonably determines, based on the clinical circumstances then existing, that strict adherence to the Protocol would pose an unacceptable risk of harm to the Study Subject. A Medically Necessary Protocol Deviation must be documented contemporaneously (or as soon as practicable under the circumstances) in the Study Subject's source documents and study records and reported to Sponsor, the applicable IRB, and the Data Safety Monitoring Board ("DSMB") in accordance with the Protocol and applicable regulations, including 21 C.F.R. § 312.62 and ICH E6(R2) Section 4.5.2. Examples of Medically Necessary Protocol Deviations may include, without limitation: dose modifications, dose interruptions, or early discontinuation of the Investigational Product based on the Investigator's assessment of a Study Subject's clinical condition; administration of concomitant medications or rescue therapies prohibited by the Protocol but deemed necessary to address an acute medical emergency; and deviations in the timing or sequence of Protocol-required assessments necessitated by urgent clinical circumstances.

1.12 "Unauthorized Protocol Deviation" shall mean any deviation from the Protocol that is not: (a) a Medically Necessary Protocol Deviation as defined in Section 1.11; (b) authorized in advance in writing by Sponsor (whether through a formal protocol amendment, a protocol clarification letter, or a written waiver issued by Sponsor's medical monitor); or (c) required by applicable law, regulation, or order of a court or regulatory authority. For the avoidance of doubt, an Unauthorized Protocol Deviation includes, without limitation, the enrollment of a Study Subject who does not meet all inclusion criteria and who meets one or more exclusion criteria set forth in the Protocol, the administration of doses of PPC-4871 in excess of those specified in the Protocol without prior written authorization from Sponsor, and the failure to obtain valid informed consent prior to any study-related procedure.

Section 2: Sponsor Indemnification of Site Indemnified Parties

2.1 General Indemnification Obligation. Subject to the terms, conditions, and exclusions set forth in this Exhibit D, Penterra shall defend, indemnify, and hold harmless each Site Indemnified Party from and against all Indemnified Losses arising from or relating to any of the following:

(a) Any Study-Related Injury caused by the Investigational Product (PPC-4871), whether active drug or matching placebo, when administered in accordance with the Protocol and the terms of the Agreement, including Study-Related Injuries arising from known or unknown risks, side effects, or adverse reactions associated with PPC-4871 that are described or not described in the Investigator's Brochure (Edition 4.0, dated March 15, 2023), the informed consent form, or the Protocol;

(b) Any Product Defect in PPC-4871 (including matching placebo), as defined in Section 1.10 hereof, regardless of whether such Product Defect is discovered before, during, or after administration to a Study Subject, and regardless of whether Sponsor was aware or should have been aware of such Product Defect at the time of administration;

(c) Any breach by Penterra of its obligations, representations, warranties, or covenants under the Agreement, any Exhibit or Schedule thereto, or the Protocol, including but not limited to any failure to provide adequate supplies of the Investigational Product, any failure to provide timely safety information or updates to the Investigator's Brochure, or any failure to maintain the IND in good standing with the FDA;

(d) Any negligent act or omission, recklessness, or willful misconduct of Penterra, its employees, agents, officers, directors, or contractors (including, without limitation, Meridian Contract Research Organization, Inc., Pinnacle Data Solutions, Inc., and Northbridge Bioanalytical Laboratories, Inc.) in connection with the design, conduct, monitoring, management, analysis, or reporting of the CLARION trial, including but not limited to errors in randomization, data management, drug supply, or pharmacovigilance; and

(e) Any failure by Penterra to comply with applicable federal, state, or local laws, rules, or regulations, or with applicable FDA requirements, including without limitation 21 C.F.R. Part 11 (Electronic Records; Electronic Signatures), 21 C.F.R. Part 50 (Protection of Human Subjects), 21 C.F.R. Part 54 (Financial Disclosure by Clinical Investigators), 21 C.F.R. Part 56 (Institutional Review Boards), 21 C.F.R. Part 312 (Investigational New Drug Application), the International Council for Harmonisation Guideline for Good Clinical Practice E6(R2) ("ICH E6(R2) GCP Guidelines"), and any other applicable regulatory requirement or guidance document.

The indemnification obligation set forth in this Section 2.1 shall apply regardless of the legal theory upon which the underlying Claim is based, including theories of negligence, strict liability, products liability, breach of warranty, breach of contract, fraud, misrepresentation, or any other theory, and regardless of whether the Claim is brought by a Study Subject, a family member of a Study Subject, a governmental authority, or any other third party.

2.2 Uncapped Indemnification for Product Defect. The indemnification obligation of Penterra under Section 2.1(b) with respect to Indemnified Losses arising from or relating to a Product Defect shall be without any monetary cap, ceiling, or other limitation on the amount of Indemnified Losses for which Penterra shall be liable. Penterra hereby acknowledges and agrees that it assumes full and unlimited financial responsibility for all Indemnified Losses arising from Product Defects in PPC-4871, regardless of the quantum, nature, or extent of such Indemnified Losses, and regardless of whether such Indemnified Losses exceed the limits of Penterra's insurance coverage. The unlimited indemnification obligation under this Section 2.2 reflects the parties' mutual recognition that Product Defects are within Penterra's exclusive control and that the Site Indemnified Parties bear no responsibility for the design, manufacture, formulation, packaging, labeling, or distribution of the Investigational Product.

2.3 Indemnification for Medically Necessary Protocol Deviations. Sponsor's indemnification obligation under Section 2.1(a) shall extend to Study-Related Injuries arising in connection with or as a consequence of Medically Necessary Protocol Deviations, provided that the Investigator has complied with the following documentation and reporting requirements:

(a) The Investigator has documented the deviation contemporaneously (or as soon as reasonably practicable under the clinical circumstances) in the Study Subject's source documents and case report forms, including a written explanation of the clinical rationale for the deviation and the Investigator's assessment of the risks and benefits of the deviation as compared to strict adherence to the Protocol;

(b) The Investigator has reported the deviation to Sponsor (via the Sponsor's medical monitor and the Meridian CRO clinical operations team) within forty-eight (48) hours of the occurrence of the deviation, or as soon as practicable if the deviation occurs over a weekend or holiday;

(c) The Investigator has reported the deviation to the applicable IRB in accordance with 21 C.F.R. § 56.108(a)(4) and the IRB's policies and procedures; and

(d) The Investigator has cooperated with any review or investigation of the deviation conducted by the DSMB, Sponsor, or the applicable IRB.

The determination of whether a protocol deviation qualifies as a Medically Necessary Protocol Deviation shall be made in good faith by the Investigator at the time of the deviation, based on the clinical information then available to the Investigator. Such determination shall be subject to subsequent review by the DSMB and the applicable IRB; provided, however, that a good-faith determination by the Investigator at the time of the deviation shall be presumed valid unless the DSMB or IRB subsequently determines, based on a preponderance of the evidence, that the deviation did not meet the criteria set forth in Section 1.11 hereof. In the event of a dispute regarding whether a deviation constitutes a Medically Necessary Protocol Deviation, the dispute shall be resolved in accordance with the procedures set forth in Section 10 hereof.

Section 3: Carve-Outs and Exclusions from Sponsor Indemnification

3.1 Exclusions. Notwithstanding anything to the contrary in Section 2, Sponsor's indemnification obligation under Section 2 shall NOT apply to Indemnified Losses to the extent that such Indemnified Losses arise from or are attributable to any of the following:

(i) The negligence, recklessness, or willful misconduct of the Participating Site, any Investigator, any sub-investigator, any study coordinator, any research nurse, or any other site personnel in the conduct of the CLARION trial at a Participating Site, including but not limited to errors in the administration of the Investigational Product, errors in the performance of Protocol-required procedures, failures to follow the Protocol, failures to obtain or maintain adequate informed consent, failures to report adverse events or safety signals, and failures to exercise the standard of care expected of a reasonably prudent clinical investigator or site in the conduct of a clinical trial of similar nature and complexity;

(ii) An Unauthorized Protocol Deviation — that is, any departure from the Protocol by an Investigator, sub-investigator, study coordinator, or other site personnel that does not qualify as a Medically Necessary Protocol Deviation under Section 1.11 and that was not authorized in advance in writing by Penterra or required by applicable law or regulation for the immediate safety of the Study Subject. For the avoidance of doubt, the enrollment of a Study Subject who does not meet the eligibility criteria specified in the Protocol, the administration of doses of PPC-4871 exceeding those specified in the Protocol without prior Sponsor authorization, the performance of study procedures not contemplated by the Protocol, and the failure to perform Protocol-required safety assessments shall each constitute an Unauthorized Protocol Deviation unless otherwise approved by Sponsor in writing or necessitated by an emergency;

(iii) A breach by Veridian, a Participating Site, or an Investigator of the Agreement, any Individual Site Agreement (Joinder), the Protocol, or applicable law, rule, or regulation, including but not limited to the Health Insurance Portability and Accountability Act of 1996, as amended ("HIPAA") (45 C.F.R. Parts 160 and 164), the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), the False Claims Act (31 U.S.C. §§ 3729–3733), applicable state anti-referral and anti-kickback statutes, applicable IRB requirements under 21 C.F.R. Part 56, and any institutional policies of the Participating Site governing the conduct of clinical research;

(iv) The use or administration of the Investigational Product (PPC-4871) for any purpose, indication, patient population, or study other than the CLARION trial as set forth in the Protocol, including any off-label use, compassionate use, or expanded access use not authorized by Sponsor and the FDA; and

(v) The administration of the Investigational Product after the expiration date marked on the product labeling or packaging, or after documented storage failures (including temperature excursions, light exposure, or humidity deviations) attributable to the Participating Site, its personnel, or its facilities, where such storage failures render the Investigational Product non-conforming with the storage conditions specified in the Investigator's Brochure and the product labeling.

3.2 Allocation of Fault. The parties acknowledge that in certain circumstances, Indemnified Losses may arise from a combination of acts or omissions by both Sponsor (or its agents or contractors) and one or more Site Indemnified Parties. In such circumstances, the indemnification obligations under this Exhibit D shall be apportioned according to the relative fault of each party, taking into account the nature, extent, and causal contribution of each party's acts or omissions to the Indemnified Losses at issue. Such apportionment shall be determined in accordance with the dispute resolution procedures set forth in Section 10 hereof and Article XIV of the Agreement. Each party shall bear the portion of Indemnified Losses attributable to its own relative fault, and neither party shall be required to indemnify the other for the portion of Indemnified Losses that is attributable to the other party's own negligence, willful misconduct, or breach. In no event shall Sponsor be required to indemnify a Site Indemnified Party for the portion of Indemnified Losses attributable to the Site Indemnified Party's own negligence, willful misconduct, or breach, and in no event shall a Site Indemnified Party be required to indemnify Sponsor for the portion of Indemnified Losses attributable to Sponsor's own negligence, willful misconduct, Product Defect, or breach.

Section 4: Study Subject Medical Care Costs

4.1 Obligation to Cover Medical Costs. In addition to and without limiting the indemnification obligations set forth in Section 2, Penterra shall bear the reasonable and customary medical costs for the diagnosis and treatment of Study-Related Injuries sustained by Study Subjects in connection with the CLARION trial, to the extent such costs satisfy each of the following conditions:

(a) Such costs are not covered, in whole or in part, by the Study Subject's own health insurance, Medicare, Medicaid, TRICARE, Veterans Affairs coverage, or other third-party payor coverage, and the Participating Site or Study Subject has made reasonable efforts to seek such coverage prior to submitting a claim under this Section 4. For the avoidance of doubt, nothing in this Section 4 shall require a Study Subject to exhaust administrative appeals or to pursue litigation against a health insurer or third-party payor as a condition of Penterra's obligation hereunder;

(b) Such costs are directly attributable to a Study-Related Injury arising from the administration of PPC-4871 (or matching placebo) or from Protocol-required study procedures, and are not attributable to the treatment of the Study Subject's underlying disease (non-small cell lung cancer) or to pre-existing conditions unrelated to the CLARION trial;

(c) Such costs are incurred at the Participating Site where the Study Subject is enrolled, or at a medical facility (including an emergency room, hospital, or specialist's office) to which the Study Subject is referred by the Investigator or treating physician for the evaluation or treatment of the Study-Related Injury; and

(d) Such costs are not attributable to an exclusion listed in Section 3.1 of this Exhibit D.

Penterra shall make payment of approved medical costs directly to the Participating Site or medical facility providing the treatment, or shall reimburse the Study Subject if the Study Subject has paid such costs out of pocket, within sixty (60) days following receipt of a complete claim submission that includes adequate documentation of the Study-Related Injury, the medical services rendered, and the costs incurred.

4.2 Per-Subject Cap. Penterra's obligation to cover medical costs under this Section 4 shall be subject to a maximum of Five Hundred Thousand Dollars ($500,000) per Study Subject per Study-Related Injury event. For purposes of this Section 4.2, a "Study-Related Injury event" shall mean a single occurrence or a series of related occurrences arising from a common cause or set of facts. Where a Study Subject sustains multiple, distinct Study-Related Injuries arising from separate and unrelated causes, each such injury shall be treated as a separate Study-Related Injury event, and the per-Subject cap shall apply separately to each such event.

4.3 Aggregate Cap. Penterra's aggregate obligation for medical costs under this Section 4 across all Study Subjects at all Participating Sites shall not exceed Fifteen Million Dollars ($15,000,000) over the life of the CLARION trial, commencing on the date of the first Study Subject's enrollment and continuing through the date on which the last Study Subject completes the final Protocol-required follow-up visit. In the event that aggregate medical costs incurred under this Section 4 approach or reach the aggregate cap, Penterra shall promptly notify Veridian and all Participating Sites, and the parties shall negotiate in good faith regarding the availability of additional coverage or alternative arrangements to address ongoing medical care obligations.

4.4 Relationship to Indemnification. The parties expressly acknowledge and agree that the per-Subject cap set forth in Section 4.2 and the aggregate cap set forth in Section 4.3 apply solely and exclusively to the medical care cost obligation under this Section 4 and do not in any way limit, reduce, cap, or otherwise affect Sponsor's indemnification obligations under Section 2 of this Exhibit D, including, without limitation, the uncapped indemnification for Product Defect claims under Section 2.2. The medical care cost obligation under Section 4 and the indemnification obligation under Section 2 are independent obligations, and the payment of medical costs under this Section 4 shall not be credited against, offset, or deducted from any indemnification amounts payable under Section 2. Conversely, amounts paid by Sponsor under Section 2 as Indemnified Losses shall not be credited against or reduce Sponsor's medical care cost obligation under this Section 4.

4.5 Coordination with Insurance. Penterra shall use commercially reasonable efforts to seek reimbursement from its clinical trial liability insurer, Briarcliff Mutual Insurance Company, under Policy No. BM-CTL-2023-04182 (which includes a subject-injury sublimit of Ten Million Dollars ($10,000,000) per occurrence and Fifty Million Dollars ($50,000,000) in the aggregate), for medical costs covered under this Section 4. Penterra shall submit claims to Briarcliff Mutual in a timely manner and shall cooperate with Briarcliff Mutual in the processing and adjustment of such claims. Notwithstanding the foregoing:

(a) The existence, availability, or adequacy of insurance coverage under the Briarcliff Mutual policy or any other insurance policy shall not relieve Penterra of its direct obligation to the Site Indemnified Parties and Study Subjects under this Section 4. Penterra's obligation to pay medical costs hereunder is a primary obligation and shall not be contingent upon, or delayed pending, any determination by Briarcliff Mutual or any other insurer regarding coverage, claim acceptance, or claim payment;

(b) In no event shall a Site Indemnified Party or Study Subject be required to pursue claims against Briarcliff Mutual Insurance Company, or any other insurer, reinsurer, or third-party guarantor, as a condition precedent to Penterra's obligation to cover medical costs under this Section 4; and

(c) In the event that Briarcliff Mutual denies coverage or pays less than the full amount of a medical cost claim submitted by Penterra, Penterra shall remain fully responsible for the balance of the medical costs covered under this Section 4, subject to the per-Subject cap and aggregate cap set forth in Sections 4.2 and 4.3.

Section 5: Reciprocal Indemnification by Veridian and Participating Sites

5.1 Site Network Indemnification Obligation. Subject to the terms, conditions, exclusions, and caps set forth in this Exhibit D, Veridian and each Participating Site (jointly and severally, as among Veridian and the applicable Participating Site at which the relevant acts or omissions occurred, but not jointly and severally as among all Participating Sites collectively, except as expressly provided in the caps set forth in Sections 5.2 and 5.3) shall defend, indemnify, and hold harmless each Sponsor Indemnified Party from and against all Indemnified Losses arising from or relating to any of the following:

(a) The negligence, recklessness, or willful misconduct of any Investigator, sub-investigator, study coordinator, research nurse, pharmacist, or other site personnel in the conduct of the CLARION trial at such Participating Site, including but not limited to errors in the administration of the Investigational Product, errors in the performance of Protocol-required procedures, failures to exercise the standard of care expected of a reasonably prudent clinical investigator or site, failures to obtain or maintain valid informed consent, and failures to report adverse events or safety signals in a timely manner;

(b) An Unauthorized Protocol Deviation by any Investigator, sub-investigator, study coordinator, or other site personnel at a Participating Site, as defined in Section 1.12 hereof, including but not limited to unauthorized enrollment of ineligible subjects, unauthorized dose modifications, and unauthorized use of prohibited concomitant medications; and

(c) A breach by Veridian or a Participating Site of the Agreement, any Individual Site Agreement (Joinder) executed under Exhibit C, the Protocol, or applicable law, rule, or regulation, including but not limited to HIPAA, applicable state privacy and data security laws, applicable IRB requirements, and applicable institutional policies governing the conduct of human subjects research.

5.2 Per-Site / Per-Occurrence Cap. The indemnification obligation of any single Participating Site under Section 5.1 shall not exceed Five Million Dollars ($5,000,000) per occurrence at that Participating Site. For purposes of this Section 5.2, a single "occurrence" shall mean a single act, omission, event, or series of related acts, omissions, or events arising from a common cause or set of facts at a single Participating Site. The per-site, per-occurrence cap set forth in this Section 5.2 reflects the parties' recognition of the nonprofit or academic status of many Participating Sites and the limitations on their respective financial resources.

5.3 Aggregate Cap. The aggregate indemnification obligation of Veridian and all Participating Sites collectively under Section 5.1 shall not exceed Twenty Million Dollars ($20,000,000) over the life of the CLARION trial, commencing on the Effective Date of the Agreement and continuing through the expiration of the survival period set forth in Section 12 hereof. In the event that aggregate Indemnified Losses under Section 5.1 approach or reach the aggregate cap, Veridian shall promptly notify Penterra, and the parties shall negotiate in good faith regarding the availability of additional coverage or alternative arrangements.

5.4 Exclusions from Site Indemnity. Notwithstanding anything to the contrary in Section 5.1, Veridian and the Participating Sites shall have no indemnification obligation under this Section 5 to the extent that Indemnified Losses arise from or are attributable to any of the following:

(a) A Product Defect, as defined in Section 1.10 hereof, regardless of when such Product Defect is discovered;

(b) The negligence, recklessness, or willful misconduct of Sponsor, its employees, agents, officers, directors, or contractors (including Meridian CRO, Pinnacle Data Solutions, Inc., and Northbridge Bioanalytical Laboratories, Inc.) in connection with the CLARION trial;

(c) A breach by Sponsor of the Agreement, any Exhibit or Schedule thereto, the Protocol, or applicable law, rule, or regulation; or

(d) A Medically Necessary Protocol Deviation that has been properly documented and reported in accordance with Section 2.3 hereof and the Protocol.

Section 6: Notice Requirements

6.1 Obligation to Provide Notice. Any Indemnified Party (whether a Site Indemnified Party or a Sponsor Indemnified Party) seeking indemnification or coverage of medical costs under this Exhibit D shall provide prompt written notice (a "Notice of Claim") to the Indemnifying Party within thirty (30) calendar days after such Indemnified Party first becomes aware of a Claim or of facts and circumstances reasonably likely to give rise to a Claim. For purposes of this Section 6.1, an Indemnified Party shall be deemed to have become "aware" of a Claim upon the earlier of (i) receipt of written notice (including a demand letter, complaint, summons, subpoena, or regulatory notice) from a third party asserting the Claim, or (ii) the date on which the Indemnified Party first obtains actual knowledge of facts and circumstances that a reasonable person would conclude are reasonably likely to result in the assertion of a Claim.

6.2 Contents of Notice. Each Notice of Claim shall include, to the extent known or reasonably available to the Indemnified Party at the time of the notice, the following information:

(a) A reasonably detailed description of the Claim or potential Claim, including the identity of the claimant or potential claimant (e.g., the Study Subject's randomization number, the name of the Participating Site, and such other identifying information as is permissible under applicable privacy laws and HIPAA);

(b) The factual basis for the Claim in reasonable detail, including a summary of the relevant events, the date(s) on which the events occurred, the names of the personnel involved, the study procedures or treatments at issue, and the nature and extent of the alleged injury or loss;

(c) A good-faith estimate of the amount of Indemnified Losses incurred or reasonably expected to be incurred by the Indemnified Party as a result of the Claim, to the extent such amount is known or can be reasonably estimated at the time of the notice; and

(d) Copies of all written demands, complaints, summonses, subpoenas, legal process, regulatory correspondence, or other written communications received by the Indemnified Party in connection with the Claim.

The Indemnified Party shall supplement the Notice of Claim promptly upon the receipt of additional material information relating to the Claim.

6.3 Delivery of Notice. All Notices of Claim and other notices required or permitted under this Exhibit D shall be in writing and shall be delivered in accordance with the notice provisions of the Agreement (Article XVI), by personal delivery, nationally recognized overnight courier (with tracking and confirmation of receipt), or certified United States mail (return receipt requested, postage prepaid), to the following addresses (or such other addresses as may be designated by a party in accordance with the notice provisions of the Agreement):

If to Penterra:

Nathaniel Briggs, Esq. Vice President & General Counsel Penterra Pharmaceuticals Corp. 200 Biopharma Boulevard, Suite 1400 Princeton, NJ 08540

with a copy (which shall not constitute notice) to:

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

and a copy (which shall not constitute notice) to:

Miriam Calloway, Esq. Calderwood & Harkness LLP 280 Park Avenue, 34th Floor New York, NY 10017

If to Veridian:

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

with a copy (which shall not constitute notice) to:

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

6.4 Effect of Late Notice. Failure to provide timely notice of a Claim within the thirty (30) calendar day period specified in Section 6.1 shall not relieve the Indemnifying Party of its indemnification obligation under this Exhibit D, except to the extent that the Indemnifying Party demonstrates, by clear and convincing evidence, that it has been materially prejudiced by such failure. Material prejudice may include, without limitation, the loss of the ability to investigate the Claim in a timely manner, the loss of the ability to assert available defenses, the destruction or unavailability of material evidence, or the imposition of increased liability as a direct result of the delay in notice. The burden of proving material prejudice shall rest solely with the Indemnifying Party. The parties agree that late notice, standing alone and without a showing of material prejudice, shall not constitute a defense to an indemnification claim under this Exhibit D.

Section 7: Defense and Settlement Procedures

7.1 Right to Assume Defense. Upon receipt of a Notice of Claim under Section 6, the Indemnifying Party shall have the right (but not the obligation) to assume the defense of such Claim, at its own expense and through counsel of its own choosing, by providing written notice to the Indemnified Party within twenty (20) business days of receipt of the Notice of Claim. The Indemnifying Party shall select defense counsel who are experienced in clinical trial liability litigation and who are reasonably acceptable to the Indemnified Party. The Indemnified Party shall not unreasonably withhold, condition, or delay its approval of the Indemnifying Party's proposed defense counsel. In the event that the Indemnified Party objects to the Indemnifying Party's proposed defense counsel, the Indemnified Party shall provide the Indemnifying Party with a written statement of its objections within ten (10) business days of receiving notice of the proposed counsel, and the Indemnifying Party shall propose alternative counsel within a further ten (10) business days.

7.2 Indemnified Party's Rights if Defense Assumed. If the Indemnifying Party timely assumes the defense of a Claim in accordance with Section 7.1:

(a) The Indemnified Party shall cooperate fully and in good faith with the Indemnifying Party and its counsel in the investigation and defense of the Claim, including by providing reasonable access to relevant documents, records (including study records, source documents, regulatory correspondence, and internal communications), and personnel (including Investigators, study coordinators, and other site staff) as reasonably requested by the Indemnifying Party, subject to applicable privileges and applicable privacy laws;

(b) The Indemnified Party shall have the right, at its own expense, to retain separate counsel to monitor, advise on, and participate in the defense of the Claim, provided that the Indemnifying Party shall retain control of the defense and settlement strategy. If, however, a conflict of interest exists between the Indemnifying Party and the Indemnified Party with respect to the Claim (as reasonably determined by the Indemnified Party's counsel), the Indemnified Party shall have the right to retain separate counsel at the Indemnifying Party's reasonable expense, and the Indemnifying Party shall pay the reasonable fees and expenses of such separate counsel; and

(c) The Indemnifying Party shall keep the Indemnified Party reasonably informed of the status of the Claim, including any material developments, settlement offers, proposed dispositions, court orders, or other significant events, and shall provide the Indemnified Party with copies of all material pleadings, motions, briefs, correspondence, and other documents filed or received in connection with the Claim, within a reasonable time after filing or receipt.

7.3 Failure to Assume Defense. If the Indemnifying Party does not provide written notice of its assumption of the defense of a Claim within the twenty (20) business day period specified in Section 7.1, or if the Indemnifying Party assumes the defense but subsequently fails to diligently and competently pursue the defense (including by failing to respond to material pleadings or motions within applicable deadlines, failing to appear at scheduled hearings or depositions, or otherwise abandoning or neglecting the defense), the Indemnified Party shall have the right to assume the defense of the Claim at the Indemnifying Party's expense, and the Indemnifying Party shall promptly reimburse the Indemnified Party for all reasonable defense costs and expenses incurred by the Indemnified Party (including reasonable attorneys' fees, expert witness fees, court costs, and costs of investigation and discovery), subject to the Indemnified Party's obligation to mitigate such costs.

7.4 Settlement. The following provisions shall govern the settlement of Claims under this Exhibit D:

(a) The Indemnifying Party shall not settle, compromise, consent to any judgment with respect to, or agree to any disposition of a Claim without the prior written consent of the Indemnified Party, which consent shall not be unreasonably withheld, conditioned, or delayed; provided, however, that the Indemnified Party's consent shall not be required for a settlement that satisfies all of the following conditions:

(i) The settlement involves solely the payment of money by the Indemnifying Party (or its insurer) and does not impose any non-monetary obligation, restriction, injunction, or other equitable relief on the Indemnified Party, including but not limited to any requirement to modify clinical trial procedures, revise informed consent forms, or take or refrain from taking any specific action;

(ii) The settlement includes a full and unconditional release of all Site Indemnified Parties or Sponsor Indemnified Parties (as applicable) from all liability and claims with respect to the Claim in question, in a form reasonably satisfactory to the Indemnified Party; and

(iii) The settlement does not involve, contain, or require any admission of fault, wrongdoing, violation of law, or liability by the Indemnified Party, whether express or implied.

(b) The Indemnified Party shall not settle, compromise, consent to any judgment with respect to, or agree to any disposition of a Claim for which it has sought indemnification under this Exhibit D without the prior written consent of the Indemnifying Party, which consent shall not be unreasonably withheld, conditioned, or delayed. Any settlement entered into by the Indemnified Party without the Indemnifying Party's prior written consent (where such consent is required under this Section 7.4(b)) shall release the Indemnifying Party from any indemnification obligation with respect to the amounts paid in such settlement, unless the Indemnifying Party's withholding of consent was unreasonable under the circumstances.

7.5 Cooperation. Each party shall cooperate fully and in good faith with the other party in the investigation, defense, and resolution of any Claim, including by:

(a) Making available, upon reasonable advance notice, all relevant personnel, including Investigators, sub-investigators, study coordinators, medical monitors, regulatory affairs personnel, and other individuals with knowledge of the facts underlying the Claim, for interviews, depositions, and testimony as may be reasonably required;

(b) Providing reasonable access to all relevant records, documents, and evidence in the possession, custody, or control of such party, including study records, source documents, case report forms, regulatory filings, adverse event reports, pharmacovigilance data, quality assurance audits, monitoring reports, and correspondence, subject to applicable privileges, confidentiality obligations, and privacy laws;

(c) Preserving all documents, records, and evidence that are relevant or potentially relevant to the Claim, in accordance with any applicable litigation hold or document preservation obligations; and

(d) Taking all reasonable steps to mitigate damages arising from or related to a Claim, including by promptly implementing corrective actions, providing appropriate medical care to affected Study Subjects, and cooperating with regulatory authorities as may be required.

The costs of cooperation (including travel expenses, employee time, and document production costs) shall be borne by the cooperating party, except that the Indemnifying Party shall reimburse the Indemnified Party for extraordinary out-of-pocket costs of cooperation that are incurred at the specific request of the Indemnifying Party or its counsel.

Section 8: Insurance

8.1 Sponsor Insurance Requirements. Penterra shall procure and maintain, at its own expense, clinical trial liability insurance (including products liability and completed operations coverage applicable to the CLARION trial) throughout the term of the Agreement and for a period of not less than three (3) years following the completion, expiration, or termination of the CLARION trial (including any extension or renewal thereof), with the following minimum coverage limits:

• Per-occurrence limit: Twenty-Five Million Dollars ($25,000,000)

• Annual aggregate limit: Seventy-Five Million Dollars ($75,000,000)

• Subject-injury sublimit: Ten Million Dollars ($10,000,000) per occurrence / Fifty Million Dollars ($50,000,000) aggregate

As of the Effective Date of the Agreement, Penterra maintains clinical trial liability insurance with Briarcliff Mutual Insurance Company under Policy No. BM-CTL-2023-04182, with a policy period of April 1, 2023 through March 31, 2024, subject to annual renewal. The policy shall be issued on an occurrence-based form or, if on a claims-made form, shall include an extended reporting period (tail coverage) of not less than three (3) years following the completion or termination of the CLARION trial.

Penterra shall cause Veridian and each Participating Site to be named as additional insureds under its clinical trial liability policy with respect to Claims arising from or related to the CLARION trial. Penterra shall ensure that its clinical trial liability policy includes a waiver of subrogation in favor of the Site Indemnified Parties with respect to Claims covered by the indemnification provisions of this Exhibit D.

8.2 Site Insurance Requirements. Veridian and each Participating Site shall procure and maintain, at their own expense, general liability insurance and professional liability (medical malpractice) insurance with the following minimum coverage limits:

• Per-occurrence limit: Five Million Dollars ($5,000,000)

• Annual aggregate limit: Ten Million Dollars ($10,000,000)

Such coverage shall be maintained throughout the term of the Agreement and for a period of not less than three (3) years following the completion or termination of the CLARION trial at the applicable Participating Site. In the case of Participating Sites that are self-insured or that participate in state-sponsored risk pools or sovereign immunity programs, such self-insurance or risk pool participation shall be deemed to satisfy the requirements of this Section 8.2, provided that Veridian delivers to Penterra a written certification describing the applicable self-insurance program or risk pool and confirming that such program provides coverage at levels at least equivalent to the minimums set forth above.

Evidence of such coverage, in the form of certificates of insurance or other written documentation reasonably acceptable to Penterra, shall be provided to Penterra within fifteen (15) business days of execution of the Agreement and annually thereafter during the term of the Agreement and any applicable survival period.

8.3 Certificate Exchange. Each party shall deliver certificates of insurance (or, in the case of self-insured entities, written certifications of self-insurance) to the other party within fifteen (15) business days of execution of the Agreement and annually thereafter during the term of the Agreement and any applicable post-termination period. Each party shall provide the other party with thirty (30) days' prior written notice of any cancellation, non-renewal, or material reduction in coverage under any policy required to be maintained under this Section 8. For purposes of this Section 8.3, a "material reduction in coverage" shall mean any reduction in per-occurrence or aggregate limits, any increase in self-insured retention or deductible, any narrowing of covered risks, or any removal of additional insured status.

8.4 Insurance Not a Limitation on Indemnification. The parties expressly acknowledge and agree that the maintenance of insurance pursuant to this Section 8 shall not limit, cap, reduce, or otherwise affect the indemnification obligations of either party under this Exhibit D. The indemnification obligations set forth in Sections 2 and 5 are direct contractual obligations, independent of and in addition to any insurance coverage maintained by either party. In the event of any inconsistency between the terms, conditions, or limitations of any insurance policy and the indemnification obligations set forth in this Exhibit D, the indemnification obligations shall govern and control as between the parties hereto.

Section 9: Subrogation and Recovery

9.1 Subrogation Rights. To the extent that the Indemnifying Party pays or is obligated to pay Indemnified Losses to or on behalf of an Indemnified Party under this Exhibit D, the Indemnifying Party shall be subrogated to all rights, claims, causes of action, and remedies of the Indemnified Party against any third party (including, without limitation, manufacturers, suppliers, contractors, subcontractors, carriers, and insurers) with respect to the Indemnified Losses for which such indemnification has been or is being provided. The Indemnified Party shall execute and deliver all documents (including assignments, powers of attorney, and consents) and take all actions reasonably requested by the Indemnifying Party to enable the Indemnifying Party to pursue, prosecute, and enforce its subrogation rights, provided that the Indemnifying Party shall reimburse the Indemnified Party for any reasonable out-of-pocket costs incurred in connection therewith.

9.2 Third-Party Recoveries. If an Indemnified Party receives any recovery, reimbursement, offset, or payment from any third party (including, without limitation, an insurance carrier, a co-defendant in litigation, a settling party, or any other source) with respect to Indemnified Losses for which indemnification has been provided by the Indemnifying Party under this Exhibit D, the Indemnified Party shall promptly (and in any event within thirty (30) calendar days of receipt) reimburse the Indemnifying Party for the amount of such recovery, net of the reasonable costs of obtaining such recovery (including attorneys' fees and litigation costs), to the extent of the indemnification previously paid by the Indemnifying Party. The Indemnified Party shall provide the Indemnifying Party with prompt written notice of any such third-party recovery.

Section 10: Dispute Resolution

10.1 Incorporation by Reference. Any dispute, controversy, or claim arising under, out of, or relating to the indemnification provisions of this Exhibit D, or the breach, validity, or interpretation thereof (each, a "Dispute"), shall be resolved in accordance with the dispute resolution procedures set forth in Article XIV of the Agreement, as summarized below and as more fully set forth therein:

(1) Negotiation. In the first instance, designated senior representatives of the parties — specifically, the Vice President & General Counsel of Penterra (or his or her designee) and the Vice President, Legal & Compliance of Veridian (or his or her designee) — shall meet (in person or by videoconference) and negotiate in good faith for a period of thirty (30) calendar days from the date on which one party delivers to the other a written notice of the Dispute, with a view toward reaching a mutually acceptable resolution.

(2) Mediation. If the Dispute is not resolved through negotiation within the thirty (30) day period described above, either party may submit the Dispute to non-binding mediation under the Commercial Mediation Rules of the American Arbitration Association ("AAA") then in effect, to be conducted in Philadelphia, Pennsylvania or New York, New York (as agreed by the parties or, absent agreement, as selected by the AAA). The mediation shall continue for a period of sixty (60) calendar days from the date on which the mediation request is filed, unless extended by mutual agreement of the parties.

(3) Binding Arbitration. If the Dispute is not resolved through mediation within the sixty (60) day period described above, the Dispute shall be finally and exclusively resolved by binding arbitration administered by the AAA in accordance with the Commercial Arbitration Rules of the AAA then in effect, to be conducted in New York, New York, before a panel of three (3) arbitrators. Each party shall select one arbitrator, and the two party-selected arbitrators shall jointly select the third arbitrator, who shall serve as chair of the panel. Each arbitrator shall have substantial experience in clinical trial agreements, pharmaceutical litigation, or healthcare law. The arbitral panel shall have the authority to award compensatory damages, equitable relief, and reasonable attorneys' fees and costs, but shall not have the authority to award punitive or exemplary damages except to the extent such damages are required by applicable law. The decision of the arbitral panel shall be final and binding upon the parties, and judgment upon the award rendered by the arbitral panel may be entered in any court of competent jurisdiction.

10.2 Injunctive Relief. Notwithstanding the foregoing dispute resolution procedures, either party may seek temporary, preliminary, or permanent injunctive or other equitable relief in the state and federal courts located in New York County, New York, to prevent irreparable harm, preserve the status quo, or enforce obligations under this Exhibit D that are not susceptible to adequate remedy through monetary damages, pending the outcome of dispute resolution. The filing of an application for injunctive or equitable relief shall not constitute a waiver of either party's right to compel arbitration under Section 10.1(3).

10.3 Governing Law. This Exhibit D and the indemnification obligations, rights, and remedies set forth herein shall be governed by, and construed and interpreted in accordance with, the substantive laws of the State of New York, without regard to its conflict-of-laws principles or rules that would result in the application of the laws of any other jurisdiction. Each party irrevocably consents to the personal jurisdiction of the state and federal courts located in New York County, New York, for purposes of any proceeding seeking injunctive or equitable relief under Section 10.2.

Section 11: Regulatory Reporting and Safety Coordination

11.1 SAE Reporting. Nothing in this Exhibit D shall be construed to affect, delay, modify, or relieve the obligation of each Participating Site and each Investigator to report serious adverse events ("SAEs") in accordance with the timelines and procedures set forth in the Protocol, the Agreement, and Exhibit J to the Agreement (Safety Reporting Plan). Without limiting the generality of the foregoing, each Participating Site shall report all SAEs to Penterra and Meridian Contract Research Organization, Inc. within twenty-four (24) hours of the Investigator's or site's awareness of the SAE, regardless of whether the SAE is believed to be related to the Investigational Product, a study procedure, or a pre-existing condition. Penterra remains solely responsible for all IND safety reporting to the FDA under IND No. 157823, including seven (7) calendar day reports for fatal and life-threatening suspected adverse reactions and fifteen (15) calendar day reports for all other reportable safety events, in accordance with 21 C.F.R. § 312.32. The assertion or pendency of an indemnification claim under this Exhibit D shall not affect, delay, or excuse any party's regulatory safety reporting obligations.

11.2 Coordination with IRBs. Indemnification claims and Study-Related Injuries shall be reported to the applicable Institutional Review Board as required by 21 C.F.R. Part 56 and applicable institutional policies. For Participating Sites located in the Commonwealth of Pennsylvania, the applicable IRB is the Graystone University Institutional Review Board (IRB Registration: IRB00012847; FWA: FWA00009831). For all non-Pennsylvania Participating Sites, the applicable IRB is the Veridian Central IRB, unless the applicable Individual Site Agreement designates a different local or central IRB. Each Participating Site shall comply with all applicable IRB reporting requirements for unanticipated problems involving risks to subjects or others, serious or continuing noncompliance, and other reportable events, in accordance with 21 C.F.R. §§ 56.108(b) and 312.66, FDA Guidance for Clinical Investigators, Sponsors, and IRBs on Adverse Event Reporting (December 2012, as updated), and the policies of the applicable IRB.

Section 12: Term and Survival

12.1 Effective Period. The indemnification obligations, medical care cost obligations, and all other rights and obligations set forth in this Exhibit D shall become effective on the Effective Date of the Agreement (June 28, 2023) and shall remain in full force and effect throughout the term of the Agreement and for the survival periods specified in this Section 12. The indemnification obligations set forth herein shall survive the expiration or termination of the Agreement for any reason, including termination for convenience, termination for cause, termination by mutual agreement, or termination due to a regulatory action.

12.2 Survival Period. The following survival periods shall apply:

(a) Sponsor's Obligations. Sponsor's indemnification obligations under Section 2 and Sponsor's medical care cost obligations under Section 4 shall survive for a period of ten (10) years following the later of: (i) the date of completion or termination of the CLARION trial (including the completion or termination of any extension study, long-term follow-up study, or ot

EXHIBIT D
Subject-Injury Indemnification Provisions
This Exhibit D (these "Indemnification Provisions") is attached to and incorporated by reference into the Master Clinical Trial Agreement dated June 28, 2023 (the "Agreement" or "MCTA"), by and between:
Penterra Pharmaceuticals Corp., a corporation organized and existing under the laws of the State of Delaware, with its principal offices located at 200 Biopharma Boulevard, Suite 1400, Princeton, New Jersey 08540 ("Sponsor" or "Penterra");
and
Veridian Health Research Network, Inc., a nonprofit corporation organized and existing under the laws of the State of Delaware and recognized as tax-exempt under Section 501(c)(3) of the Internal Revenue Code, with its principal offices located at 750 Research Parkway, 8th Floor, Philadelphia, Pennsylvania 19104 ("Site Network" or "Veridian").
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 herein shall have the meanings ascribed to them in the Agreement. In the event of any conflict between the terms of this Exhibit D and the terms of the Agreement, the terms of this Exhibit D shall govern with respect to the subject matter addressed herein, unless the Agreement expressly provides otherwise.
Section 1: Definitions
For purposes of this Exhibit D, the following terms shall have the meanings set forth below:
1.1 "Claim" shall mean any demand, action, suit, proceeding (whether at law, in equity, or before any administrative or regulatory body), investigation, or claim by a third party (including, without limitation, a Study Subject, any estate or personal representative of a Study Subject, any family member of a Study Subject, or any legal representative of any of the foregoing) asserted against an Indemnified Party, whether such demand, action, suit, proceeding, investigation, or claim is formal or informal, written or oral, and regardless of whether it is brought in a court of competent jurisdiction, before an arbitral tribunal, before a regulatory agency, or otherwise. A Claim shall include, without limitation, claims sounding in tort, contract, strict liability, products liability, medical malpractice, fraud, breach of fiduciary duty, violation of statute, or any other legal theory.
1.2 "Indemnified Losses" shall mean all claims, losses, damages (including compensatory, consequential, incidental, special, and punitive damages to the extent awarded by a court or arbitral panel of competent jurisdiction), liabilities, judgments, settlements, penalties, fines, costs, and expenses (including, without limitation, reasonable attorneys' fees, expert witness fees, court costs, costs of investigation, and costs of appeal) arising from, relating to, or in connection with a Claim. For the avoidance of doubt, Indemnified Losses shall include all out-of-pocket costs and expenses reasonably incurred by the Indemnified Party in cooperating with the investigation, defense, or resolution of a Claim, as well as any amounts paid in settlement of a Claim in accordance with the procedures set forth in Section 7 hereof.
1.3 "Investigator" shall mean each principal investigator, co-principal investigator, and sub-investigator identified on the applicable Form FDA 1572 (Statement of Investigator) for each Participating Site, as such Form FDA 1572 may be amended or supplemented from time to time during the course of the CLARION trial. As of the Effective Date of the Agreement, the Investigators include, without limitation, Dr. Catherine Aldridge, M.D., Ph.D. (Global Principal Investigator, Graystone University Medical Center, Philadelphia, Pennsylvania) and Dr. Howard Matsuoka, M.D. (Co-Principal Investigator, Lakemont Medical Center, Rochester, Minnesota). Additional Investigators may be added or removed during the course of the CLARION trial in accordance with the Protocol and applicable regulatory requirements, and such additions or removals shall not require an amendment to this Exhibit D.
1.4 "Participating Site" shall mean each academic medical center, hospital, research institution, or clinical facility within the Veridian Health Research Network that is listed on Schedule 1 to the Agreement and that has executed an Individual Site Agreement (Joinder) under Exhibit C to the Agreement, thereby agreeing to conduct the CLARION trial in accordance with the Protocol and the terms of the Agreement. As of the Effective Date of the Agreement, there are thirty-eight (38) Participating Sites located across fourteen (14) states within the United States. Each Participating Site shall be deemed a party to this Exhibit D by virtue of its execution of the applicable Individual Site Agreement (Joinder), which incorporates the terms of this Exhibit D by reference.
1.5 "Protocol" shall mean Protocol PPC-4871-III, titled "Clinical Assessment of Response with Longitudinal Investigation in ONcology (CLARION): A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Penterafenib (PPC-4871) in Adult Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring BRAF V600E Mutations," as may be amended from time to time with the approval of the U.S. Food and Drug Administration ("FDA") and the applicable Institutional Review Board(s) ("IRB(s)"), including all protocol amendments, addenda, and clarification letters issued by Sponsor.
1.6 "Site Indemnified Parties" shall mean, collectively: (a) Veridian Health Research Network, Inc.; (b) each Participating Site (including, without limitation, Graystone University Medical Center and Lakemont Medical Center); (c) each Investigator; (d) each sub-investigator; (e) each study coordinator, research nurse, clinical research associate, data entry specialist, pharmacist, and other site personnel acting within the scope of their duties under the Protocol and this Agreement; (f) the officers, directors, trustees, employees, agents, and volunteers of each of the foregoing entities; and (g) the respective successors and assigns of each of the foregoing. For the avoidance of doubt, Site Indemnified Parties shall include all personnel identified on the delegation of authority log maintained at each Participating Site pursuant to the Protocol.
1.7 "Sponsor Indemnified Parties" shall mean, collectively: (a) Penterra Pharmaceuticals Corp.; (b) its officers, directors, employees, agents, and representatives; (c) its parent companies, subsidiaries, and affiliates; and (d) the respective successors and assigns of each of the foregoing.
1.8 "Study Subject" shall mean each individual who has been enrolled and randomized in the CLARION trial pursuant to the Protocol, including individuals who have signed an informed consent form approved by the applicable IRB and who have been assigned a randomization number. The planned enrollment for the CLARION trial is approximately 1,200 Study Subjects, randomized in a 2:1 ratio (penterafenib:placebo). For purposes of this Exhibit D, a "Study Subject" shall include any individual who receives any dose of the Investigational Product or placebo, regardless of whether such individual completes the full course of treatment contemplated by the Protocol.
1.9 "Study-Related Injury" shall mean any bodily injury, illness, disease, adverse health consequence, disability, or death sustained by a Study Subject that is caused by or directly results from: (a) the administration of the Investigational Product (PPC-4871), whether active drug or matching placebo, in connection with the CLARION trial; (b) any study procedure, examination, test, assessment, or intervention required by or performed pursuant to the Protocol, including but not limited to blood draws, biopsies, imaging studies, electrocardiograms, pharmacokinetic sampling, and any other diagnostic or therapeutic procedure mandated by the Protocol that would not otherwise be performed as part of the Study Subject's standard medical care; or (c) any defect in the design, manufacture, formulation, packaging, labeling, storage, or handling of the Investigational Product that is attributable to Sponsor or its agents. A Study-Related Injury shall not include the progression of the Study Subject's underlying disease (i.e., non-small cell lung cancer) unless such progression is proximately caused by a Product Defect or the negligent administration of the Investigational Product.
1.10 "Product Defect" shall mean any defect in the design, manufacture, formulation, compounding, packaging, labeling, storage, handling, or distribution of PPC-4871 (including matching placebo) that is attributable to Sponsor or any of its agents, contractors, subcontractors, or designees, including without limitation Meridian Contract Research Organization, Inc. ("Meridian CRO"), Northbridge Bioanalytical Laboratories, Inc. ("Northbridge"), or any other Sponsor-designated contract manufacturer, contract research organization, central laboratory, or logistics provider engaged by Sponsor in connection with the CLARION trial. A Product Defect shall include, without limitation: (i) contamination or adulteration of the Investigational Product; (ii) failure of the Investigational Product to meet its approved specifications or certificate of analysis; (iii) errors in labeling, packaging, or coding (including randomization code errors); (iv) failure to maintain required storage conditions during transport or distribution prior to delivery to the Participating Site; and (v) any inherent design defect in the molecular entity that renders PPC-4871 unreasonably dangerous when used as directed in the Protocol.
1.11 "Medically Necessary Protocol Deviation" shall mean a departure from the Protocol undertaken by an Investigator in good faith and in the exercise of reasonable medical judgment to protect the life, safety, or welfare of a Study Subject, where the Investigator reasonably determines, based on the clinical circumstances then existing, that strict adherence to the Protocol would pose an unacceptable risk of harm to the Study Subject. A Medically Necessary Protocol Deviation must be documented contemporaneously (or as soon as practicable under the circumstances) in the Study Subject's source documents and study records and reported to Sponsor, the applicable IRB, and the Data Safety Monitoring Board ("DSMB") in accordance with the Protocol and applicable regulations, including 21 C.F.R. § 312.62 and ICH E6(R2) Section 4.5.2. Examples of Medically Necessary Protocol Deviations may include, without limitation: dose modifications, dose interruptions, or early discontinuation of the Investigational Product based on the Investigator's assessment of a Study Subject's clinical condition; administration of concomitant medications or rescue therapies prohibited by the Protocol but deemed necessary to address an acute medical emergency; and deviations in the timing or sequence of Protocol-required assessments necessitated by urgent clinical circumstances.
1.12 "Unauthorized Protocol Deviation" shall mean any deviation from the Protocol that is not: (a) a Medically Necessary Protocol Deviation as defined in Section 1.11; (b) authorized in advance in writing by Sponsor (whether through a formal protocol amendment, a protocol clarification letter, or a written waiver issued by Sponsor's medical monitor); or (c) required by applicable law, regulation, or order of a court or regulatory authority. For the avoidance of doubt, an Unauthorized Protocol Deviation includes, without limitation, the enrollment of a Study Subject who does not meet all inclusion criteria and who meets one or more exclusion criteria set forth in the Protocol, the administration of doses of PPC-4871 in excess of those specified in the Protocol without prior written authorization from Sponsor, and the failure to obtain valid informed consent prior to any study-related procedure.
Section 2: Sponsor Indemnification of Site Indemnified Parties
2.1 General Indemnification Obligation. Subject to the terms, conditions, and exclusions set forth in this Exhibit D, Penterra shall defend, indemnify, and hold harmless each Site Indemnified Party from and against all Indemnified Losses arising from or relating to any of the following:
(a) Any Study-Related Injury caused by the Investigational Product (PPC-4871), whether active drug or matching placebo, when administered in accordance with the Protocol and the terms of the Agreement, including Study-Related Injuries arising from known or unknown risks, side effects, or adverse reactions associated with PPC-4871 that are described or not described in the Investigator's Brochure (Edition 4.0, dated March 15, 2023), the informed consent form, or the Protocol;
(b) Any Product Defect in PPC-4871 (including matching placebo), as defined in Section 1.10 hereof, regardless of whether such Product Defect is discovered before, during, or after administration to a Study Subject, and regardless of whether Sponsor was aware or should have been aware of such Product Defect at the time of administration;
(c) Any breach by Penterra of its obligations, representations, warranties, or covenants under the Agreement, any Exhibit or Schedule thereto, or the Protocol, including but not limited to any failure to provide adequate supplies of the Investigational Product, any failure to provide timely safety information or updates to the Investigator's Brochure, or any failure to maintain the IND in good standing with the FDA;
(d) Any negligent act or omission, recklessness, or willful misconduct of Penterra, its employees, agents, officers, directors, or contractors (including, without limitation, Meridian Contract Research Organization, Inc., Pinnacle Data Solutions, Inc., and Northbridge Bioanalytical Laboratories, Inc.) in connection with the design, conduct, monitoring, management, analysis, or reporting of the CLARION trial, including but not limited to errors in randomization, data management, drug supply, or pharmacovigilance; and
(e) Any failure by Penterra to comply with applicable federal, state, or local laws, rules, or regulations, or with applicable FDA requirements, including without limitation 21 C.F.R. Part 11 (Electronic Records; Electronic Signatures), 21 C.F.R. Part 50 (Protection of Human Subjects), 21 C.F.R. Part 54 (Financial Disclosure by Clinical Investigators), 21 C.F.R. Part 56 (Institutional Review Boards), 21 C.F.R. Part 312 (Investigational New Drug Application), the International Council for Harmonisation Guideline for Good Clinical Practice E6(R2) ("ICH E6(R2) GCP Guidelines"), and any other applicable regulatory requirement or guidance document.
The indemnification obligation set forth in this Section 2.1 shall apply regardless of the legal theory upon which the underlying Claim is based, including theories of negligence, strict liability, products liability, breach of warranty, breach of contract, fraud, misrepresentation, or any other theory, and regardless of whether the Claim is brought by a Study Subject, a family member of a Study Subject, a governmental authority, or any other third party.
2.2 Uncapped Indemnification for Product Defect. The indemnification obligation of Penterra under Section 2.1(b) with respect to Indemnified Losses arising from or relating to a Product Defect shall be without any monetary cap, ceiling, or other limitation on the amount of Indemnified Losses for which Penterra shall be liable. Penterra hereby acknowledges and agrees that it assumes full and unlimited financial responsibility for all Indemnified Losses arising from Product Defects in PPC-4871, regardless of the quantum, nature, or extent of such Indemnified Losses, and regardless of whether such Indemnified Losses exceed the limits of Penterra's insurance coverage. The unlimited indemnification obligation under this Section 2.2 reflects the parties' mutual recognition that Product Defects are within Penterra's exclusive control and that the Site Indemnified Parties bear no responsibility for the design, manufacture, formulation, packaging, labeling, or distribution of the Investigational Product.
2.3 Indemnification for Medically Necessary Protocol Deviations. Sponsor's indemnification obligation under Section 2.1(a) shall extend to Study-Related Injuries arising in connection with or as a consequence of Medically Necessary Protocol Deviations, provided that the Investigator has complied with the following documentation and reporting requirements:
(a) The Investigator has documented the deviation contemporaneously (or as soon as reasonably practicable under the clinical circumstances) in the Study Subject's source documents and case report forms, including a written explanation of the clinical rationale for the deviation and the Investigator's assessment of the risks and benefits of the deviation as compared to strict adherence to the Protocol;
(b) The Investigator has reported the deviation to Sponsor (via the Sponsor's medical monitor and the Meridian CRO clinical operations team) within forty-eight (48) hours of the occurrence of the deviation, or as soon as practicable if the deviation occurs over a weekend or holiday;
(c) The Investigator has reported the deviation to the applicable IRB in accordance with 21 C.F.R. § 56.108(a)(4) and the IRB's policies and procedures; and
(d) The Investigator has cooperated with any review or investigation of the deviation conducted by the DSMB, Sponsor, or the applicable IRB.
The determination of whether a protocol deviation qualifies as a Medically Necessary Protocol Deviation shall be made in good faith by the Investigator at the time of the deviation, based on the clinical information then available to the Investigator. Such determination shall be subject to subsequent review by the DSMB and the applicable IRB; provided, however, that a good-faith determination by the Investigator at the time of the deviation shall be presumed valid unless the DSMB or IRB subsequently determines, based on a preponderance of the evidence, that the deviation did not meet the criteria set forth in Section 1.11 hereof. In the event of a dispute regarding whether a deviation constitutes a Medically Necessary Protocol Deviation, the dispute shall be resolved in accordance with the procedures set forth in Section 10 hereof.
Section 3: Carve-Outs and Exclusions from Sponsor Indemnification
3.1 Exclusions. Notwithstanding anything to the contrary in Section 2, Sponsor's indemnification obligation under Section 2 shall NOT apply to Indemnified Losses to the extent that such Indemnified Losses arise from or are attributable to any of the following:
(i) The negligence, recklessness, or willful misconduct of the Participating Site, any Investigator, any sub-investigator, any study coordinator, any research nurse, or any other site personnel in the conduct of the CLARION trial at a Participating Site, including but not limited to errors in the administration of the Investigational Product, errors in the performance of Protocol-required procedures, failures to follow the Protocol, failures to obtain or maintain adequate informed consent, failures to report adverse events or safety signals, and failures to exercise the standard of care expected of a reasonably prudent clinical investigator or site in the conduct of a clinical trial of similar nature and complexity;
(ii) An Unauthorized Protocol Deviation — that is, any departure from the Protocol by an Investigator, sub-investigator, study coordinator, or other site personnel that does not qualify as a Medically Necessary Protocol Deviation under Section 1.11 and that was not authorized in advance in writing by Penterra or required by applicable law or regulation for the immediate safety of the Study Subject. For the avoidance of doubt, the enrollment of a Study Subject who does not meet the eligibility criteria specified in the Protocol, the administration of doses of PPC-4871 exceeding those specified in the Protocol without prior Sponsor authorization, the performance of study procedures not contemplated by the Protocol, and the failure to perform Protocol-required safety assessments shall each constitute an Unauthorized Protocol Deviation unless otherwise approved by Sponsor in writing or necessitated by an emergency;
(iii) A breach by Veridian, a Participating Site, or an Investigator of the Agreement, any Individual Site Agreement (Joinder), the Protocol, or applicable law, rule, or regulation, including but not limited to the Health Insurance Portability and Accountability Act of 1996, as amended ("HIPAA") (45 C.F.R. Parts 160 and 164), the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), the False Claims Act (31 U.S.C. §§ 3729–3733), applicable state anti-referral and anti-kickback statutes, applicable IRB requirements under 21 C.F.R. Part 56, and any institutional policies of the Participating Site governing the conduct of clinical research;
(iv) The use or administration of the Investigational Product (PPC-4871) for any purpose, indication, patient population, or study other than the CLARION trial as set forth in the Protocol, including any off-label use, compassionate use, or expanded access use not authorized by Sponsor and the FDA; and
(v) The administration of the Investigational Product after the expiration date marked on the product labeling or packaging, or after documented storage failures (including temperature excursions, light exposure, or humidity deviations) attributable to the Participating Site, its personnel, or its facilities, where such storage failures render the Investigational Product non-conforming with the storage conditions specified in the Investigator's Brochure and the product labeling.
3.2 Allocation of Fault. The parties acknowledge that in certain circumstances, Indemnified Losses may arise from a combination of acts or omissions by both Sponsor (or its agents or contractors) and one or more Site Indemnified Parties. In such circumstances, the indemnification obligations under this Exhibit D shall be apportioned according to the relative fault of each party, taking into account the nature, extent, and causal contribution of each party's acts or omissions to the Indemnified Losses at issue. Such apportionment shall be determined in accordance with the dispute resolution procedures set forth in Section 10 hereof and Article XIV of the Agreement. Each party shall bear the portion of Indemnified Losses attributable to its own relative fault, and neither party shall be required to indemnify the other for the portion of Indemnified Losses that is attributable to the other party's own negligence, willful misconduct, or breach. In no event shall Sponsor be required to indemnify a Site Indemnified Party for the portion of Indemnified Losses attributable to the Site Indemnified Party's own negligence, willful misconduct, or breach, and in no event shall a Site Indemnified Party be required to indemnify Sponsor for the portion of Indemnified Losses attributable to Sponsor's own negligence, willful misconduct, Product Defect, or breach.
Section 4: Study Subject Medical Care Costs
4.1 Obligation to Cover Medical Costs. In addition to and without limiting the indemnification obligations set forth in Section 2, Penterra shall bear the reasonable and customary medical costs for the diagnosis and treatment of Study-Related Injuries sustained by Study Subjects in connection with the CLARION trial, to the extent such costs satisfy each of the following conditions:
(a) Such costs are not covered, in whole or in part, by the Study Subject's own health insurance, Medicare, Medicaid, TRICARE, Veterans Affairs coverage, or other third-party payor coverage, and the Participating Site or Study Subject has made reasonable efforts to seek such coverage prior to submitting a claim under this Section 4. For the avoidance of doubt, nothing in this Section 4 shall require a Study Subject to exhaust administrative appeals or to pursue litigation against a health insurer or third-party payor as a condition of Penterra's obligation hereunder;
(b) Such costs are directly attributable to a Study-Related Injury arising from the administration of PPC-4871 (or matching placebo) or from Protocol-required study procedures, and are not attributable to the treatment of the Study Subject's underlying disease (non-small cell lung cancer) or to pre-existing conditions unrelated to the CLARION trial;
(c) Such costs are incurred at the Participating Site where the Study Subject is enrolled, or at a medical facility (including an emergency room, hospital, or specialist's office) to which the Study Subject is referred by the Investigator or treating physician for the evaluation or treatment of the Study-Related Injury; and
(d) Such costs are not attributable to an exclusion listed in Section 3.1 of this Exhibit D.
Penterra shall make payment of approved medical costs directly to the Participating Site or medical facility providing the treatment, or shall reimburse the Study Subject if the Study Subject has paid such costs out of pocket, within sixty (60) days following receipt of a complete claim submission that includes adequate documentation of the Study-Related Injury, the medical services rendered, and the costs incurred.
4.2 Per-Subject Cap. Penterra's obligation to cover medical costs under this Section 4 shall be subject to a maximum of Five Hundred Thousand Dollars ($500,000) per Study Subject per Study-Related Injury event. For purposes of this Section 4.2, a "Study-Related Injury event" shall mean a single occurrence or a series of related occurrences arising from a common cause or set of facts. Where a Study Subject sustains multiple, distinct Study-Related Injuries arising from separate and unrelated causes, each such injury shall be treated as a separate Study-Related Injury event, and the per-Subject cap shall apply separately to each such event.
4.3 Aggregate Cap. Penterra's aggregate obligation for medical costs under this Section 4 across all Study Subjects at all Participating Sites shall not exceed Fifteen Million Dollars ($15,000,000) over the life of the CLARION trial, commencing on the date of the first Study Subject's enrollment and continuing through the date on which the last Study Subject completes the final Protocol-required follow-up visit. In the event that aggregate medical costs incurred under this Section 4 approach or reach the aggregate cap, Penterra shall promptly notify Veridian and all Participating Sites, and the parties shall negotiate in good faith regarding the availability of additional coverage or alternative arrangements to address ongoing medical care obligations.
4.4 Relationship to Indemnification. The parties expressly acknowledge and agree that the per-Subject cap set forth in Section 4.2 and the aggregate cap set forth in Section 4.3 apply solely and exclusively to the medical care cost obligation under this Section 4 and do not in any way limit, reduce, cap, or otherwise affect Sponsor's indemnification obligations under Section 2 of this Exhibit D, including, without limitation, the uncapped indemnification for Product Defect claims under Section 2.2. The medical care cost obligation under Section 4 and the indemnification obligation under Section 2 are independent obligations, and the payment of medical costs under this Section 4 shall not be credited against, offset, or deducted from any indemnification amounts payable under Section 2. Conversely, amounts paid by Sponsor under Section 2 as Indemnified Losses shall not be credited against or reduce Sponsor's medical care cost obligation under this Section 4.
4.5 Coordination with Insurance. Penterra shall use commercially reasonable efforts to seek reimbursement from its clinical trial liability insurer, Briarcliff Mutual Insurance Company, under Policy No. BM-CTL-2023-04182 (which includes a subject-injury sublimit of Ten Million Dollars ($10,000,000) per occurrence and Fifty Million Dollars ($50,000,000) in the aggregate), for medical costs covered under this Section 4. Penterra shall submit claims to Briarcliff Mutual in a timely manner and shall cooperate with Briarcliff Mutual in the processing and adjustment of such claims. Notwithstanding the foregoing:
(a) The existence, availability, or adequacy of insurance coverage under the Briarcliff Mutual policy or any other insurance policy shall not relieve Penterra of its direct obligation to the Site Indemnified Parties and Study Subjects under this Section 4. Penterra's obligation to pay medical costs hereunder is a primary obligation and shall not be contingent upon, or delayed pending, any determination by Briarcliff Mutual or any other insurer regarding coverage, claim acceptance, or claim payment;
(b) In no event shall a Site Indemnified Party or Study Subject be required to pursue claims against Briarcliff Mutual Insurance Company, or any other insurer, reinsurer, or third-party guarantor, as a condition precedent to Penterra's obligation to cover medical costs under this Section 4; and
(c) In the event that Briarcliff Mutual denies coverage or pays less than the full amount of a medical cost claim submitted by Penterra, Penterra shall remain fully responsible for the balance of the medical costs covered under this Section 4, subject to the per-Subject cap and aggregate cap set forth in Sections 4.2 and 4.3.
Section 5: Reciprocal Indemnification by Veridian and Participating Sites
5.1 Site Network Indemnification Obligation. Subject to the terms, conditions, exclusions, and caps set forth in this Exhibit D, Veridian and each Participating Site (jointly and severally, as among Veridian and the applicable Participating Site at which the relevant acts or omissions occurred, but not jointly and severally as among all Participating Sites collectively, except as expressly provided in the caps set forth in Sections 5.2 and 5.3) shall defend, indemnify, and hold harmless each Sponsor Indemnified Party from and against all Indemnified Losses arising from or relating to any of the following:
(a) The negligence, recklessness, or willful misconduct of any Investigator, sub-investigator, study coordinator, research nurse, pharmacist, or other site personnel in the conduct of the CLARION trial at such Participating Site, including but not limited to errors in the administration of the Investigational Product, errors in the performance of Protocol-required procedures, failures to exercise the standard of care expected of a reasonably prudent clinical investigator or site, failures to obtain or maintain valid informed consent, and failures to report adverse events or safety signals in a timely manner;
(b) An Unauthorized Protocol Deviation by any Investigator, sub-investigator, study coordinator, or other site personnel at a Participating Site, as defined in Section 1.12 hereof, including but not limited to unauthorized enrollment of ineligible subjects, unauthorized dose modifications, and unauthorized use of prohibited concomitant medications; and
(c) A breach by Veridian or a Participating Site of the Agreement, any Individual Site Agreement (Joinder) executed under Exhibit C, the Protocol, or applicable law, rule, or regulation, including but not limited to HIPAA, applicable state privacy and data security laws, applicable IRB requirements, and applicable institutional policies governing the conduct of human subjects research.
5.2 Per-Site / Per-Occurrence Cap. The indemnification obligation of any single Participating Site under Section 5.1 shall not exceed Five Million Dollars ($5,000,000) per occurrence at that Participating Site. For purposes of this Section 5.2, a single "occurrence" shall mean a single act, omission, event, or series of related acts, omissions, or events arising from a common cause or set of facts at a single Participating Site. The per-site, per-occurrence cap set forth in this Section 5.2 reflects the parties' recognition of the nonprofit or academic status of many Participating Sites and the limitations on their respective financial resources.
5.3 Aggregate Cap. The aggregate indemnification obligation of Veridian and all Participating Sites collectively under Section 5.1 shall not exceed Twenty Million Dollars ($20,000,000) over the life of the CLARION trial, commencing on the Effective Date of the Agreement and continuing through the expiration of the survival period set forth in Section 12 hereof. In the event that aggregate Indemnified Losses under Section 5.1 approach or reach the aggregate cap, Veridian shall promptly notify Penterra, and the parties shall negotiate in good faith regarding the availability of additional coverage or alternative arrangements.
5.4 Exclusions from Site Indemnity. Notwithstanding anything to the contrary in Section 5.1, Veridian and the Participating Sites shall have no indemnification obligation under this Section 5 to the extent that Indemnified Losses arise from or are attributable to any of the following:
(a) A Product Defect, as defined in Section 1.10 hereof, regardless of when such Product Defect is discovered;
(b) The negligence, recklessness, or willful misconduct of Sponsor, its employees, agents, officers, directors, or contractors (including Meridian CRO, Pinnacle Data Solutions, Inc., and Northbridge Bioanalytical Laboratories, Inc.) in connection with the CLARION trial;
(c) A breach by Sponsor of the Agreement, any Exhibit or Schedule thereto, the Protocol, or applicable law, rule, or regulation; or
(d) A Medically Necessary Protocol Deviation that has been properly documented and reported in accordance with Section 2.3 hereof and the Protocol.
Section 6: Notice Requirements
6.1 Obligation to Provide Notice. Any Indemnified Party (whether a Site Indemnified Party or a Sponsor Indemnified Party) seeking indemnification or coverage of medical costs under this Exhibit D shall provide prompt written notice (a "Notice of Claim") to the Indemnifying Party within thirty (30) calendar days after such Indemnified Party first becomes aware of a Claim or of facts and circumstances reasonably likely to give rise to a Claim. For purposes of this Section 6.1, an Indemnified Party shall be deemed to have become "aware" of a Claim upon the earlier of (i) receipt of written notice (including a demand letter, complaint, summons, subpoena, or regulatory notice) from a third party asserting the Claim, or (ii) the date on which the Indemnified Party first obtains actual knowledge of facts and circumstances that a reasonable person would conclude are reasonably likely to result in the assertion of a Claim.
6.2 Contents of Notice. Each Notice of Claim shall include, to the extent known or reasonably available to the Indemnified Party at the time of the notice, the following information:
(a) A reasonably detailed description of the Claim or potential Claim, including the identity of the claimant or potential claimant (e.g., the Study Subject's randomization number, the name of the Participating Site, and such other identifying information as is permissible under applicable privacy laws and HIPAA);
(b) The factual basis for the Claim in reasonable detail, including a summary of the relevant events, the date(s) on which the events occurred, the names of the personnel involved, the study procedures or treatments at issue, and the nature and extent of the alleged injury or loss;
(c) A good-faith estimate of the amount of Indemnified Losses incurred or reasonably expected to be incurred by the Indemnified Party as a result of the Claim, to the extent such amount is known or can be reasonably estimated at the time of the notice; and
(d) Copies of all written demands, complaints, summonses, subpoenas, legal process, regulatory correspondence, or other written communications received by the Indemnified Party in connection with the Claim.
The Indemnified Party shall supplement the Notice of Claim promptly upon the receipt of additional material information relating to the Claim.
6.3 Delivery of Notice. All Notices of Claim and other notices required or permitted under this Exhibit D shall be in writing and shall be delivered in accordance with the notice provisions of the Agreement (Article XVI), by personal delivery, nationally recognized overnight courier (with tracking and confirmation of receipt), or certified United States mail (return receipt requested, postage prepaid), to the following addresses (or such other addresses as may be designated by a party in accordance with the notice provisions of the Agreement):
If to Penterra:
Nathaniel Briggs, Esq. Vice President & General Counsel Penterra Pharmaceuticals Corp. 200 Biopharma Boulevard, Suite 1400 Princeton, NJ 08540
with a copy (which shall not constitute notice) to:
Rebecca Liang, Esq. Associate General Counsel, Clinical Affairs Penterra Pharmaceuticals Corp. 200 Biopharma Boulevard, Suite 1400 Princeton, NJ 08540
and a copy (which shall not constitute notice) to:
Miriam Calloway, Esq. Calderwood & Harkness LLP 280 Park Avenue, 34th Floor New York, NY 10017
If to Veridian:
Gregory Callahan, Esq. Vice President, Legal & Compliance Veridian Health Research Network, Inc. 750 Research Parkway, 8th Floor Philadelphia, PA 19104
with a copy (which shall not constitute notice) to:
Allison Whitmore, Esq. Whitmore, Jansen & Callahan LLP 1500 Market Street, Suite 3200 Philadelphia, PA 19102
6.4 Effect of Late Notice. Failure to provide timely notice of a Claim within the thirty (30) calendar day period specified in Section 6.1 shall not relieve the Indemnifying Party of its indemnification obligation under this Exhibit D, except to the extent that the Indemnifying Party demonstrates, by clear and convincing evidence, that it has been materially prejudiced by such failure. Material prejudice may include, without limitation, the loss of the ability to investigate the Claim in a timely manner, the loss of the ability to assert available defenses, the destruction or unavailability of material evidence, or the imposition of increased liability as a direct result of the delay in notice. The burden of proving material prejudice shall rest solely with the Indemnifying Party. The parties agree that late notice, standing alone and without a showing of material prejudice, shall not constitute a defense to an indemnification claim under this Exhibit D.
Section 7: Defense and Settlement Procedures
7.1 Right to Assume Defense. Upon receipt of a Notice of Claim under Section 6, the Indemnifying Party shall have the right (but not the obligation) to assume the defense of such Claim, at its own expense and through counsel of its own choosing, by providing written notice to the Indemnified Party within twenty (20) business days of receipt of the Notice of Claim. The Indemnifying Party shall select defense counsel who are experienced in clinical trial liability litigation and who are reasonably acceptable to the Indemnified Party. The Indemnified Party shall not unreasonably withhold, condition, or delay its approval of the Indemnifying Party's proposed defense counsel. In the event that the Indemnified Party objects to the Indemnifying Party's proposed defense counsel, the Indemnified Party shall provide the Indemnifying Party with a written statement of its objections within ten (10) business days of receiving notice of the proposed counsel, and the Indemnifying Party shall propose alternative counsel within a further ten (10) business days.
7.2 Indemnified Party's Rights if Defense Assumed. If the Indemnifying Party timely assumes the defense of a Claim in accordance with Section 7.1:
(a) The Indemnified Party shall cooperate fully and in good faith with the Indemnifying Party and its counsel in the investigation and defense of the Claim, including by providing reasonable access to relevant documents, records (including study records, source documents, regulatory correspondence, and internal communications), and personnel (including Investigators, study coordinators, and other site staff) as reasonably requested by the Indemnifying Party, subject to applicable privileges and applicable privacy laws;
(b) The Indemnified Party shall have the right, at its own expense, to retain separate counsel to monitor, advise on, and participate in the defense of the Claim, provided that the Indemnifying Party shall retain control of the defense and settlement strategy. If, however, a conflict of interest exists between the Indemnifying Party and the Indemnified Party with respect to the Claim (as reasonably determined by the Indemnified Party's counsel), the Indemnified Party shall have the right to retain separate counsel at the Indemnifying Party's reasonable expense, and the Indemnifying Party shall pay the reasonable fees and expenses of such separate counsel; and
(c) The Indemnifying Party shall keep the Indemnified Party reasonably informed of the status of the Claim, including any material developments, settlement offers, proposed dispositions, court orders, or other significant events, and shall provide the Indemnified Party with copies of all material pleadings, motions, briefs, correspondence, and other documents filed or received in connection with the Claim, within a reasonable time after filing or receipt.
7.3 Failure to Assume Defense. If the Indemnifying Party does not provide written notice of its assumption of the defense of a Claim within the twenty (20) business day period specified in Section 7.1, or if the Indemnifying Party assumes the defense but subsequently fails to diligently and competently pursue the defense (including by failing to respond to material pleadings or motions within applicable deadlines, failing to appear at scheduled hearings or depositions, or otherwise abandoning or neglecting the defense), the Indemnified Party shall have the right to assume the defense of the Claim at the Indemnifying Party's expense, and the Indemnifying Party shall promptly reimburse the Indemnified Party for all reasonable defense costs and expenses incurred by the Indemnified Party (including reasonable attorneys' fees, expert witness fees, court costs, and costs of investigation and discovery), subject to the Indemnified Party's obligation to mitigate such costs.
7.4 Settlement. The following provisions shall govern the settlement of Claims under this Exhibit D:
(a) The Indemnifying Party shall not settle, compromise, consent to any judgment with respect to, or agree to any disposition of a Claim without the prior written consent of the Indemnified Party, which consent shall not be unreasonably withheld, conditioned, or delayed; provided, however, that the Indemnified Party's consent shall not be required for a settlement that satisfies all of the following conditions:
(i) The settlement involves solely the payment of money by the Indemnifying Party (or its insurer) and does not impose any non-monetary obligation, restriction, injunction, or other equitable relief on the Indemnified Party, including but not limited to any requirement to modify clinical trial procedures, revise informed consent forms, or take or refrain from taking any specific action;
(ii) The settlement includes a full and unconditional release of all Site Indemnified Parties or Sponsor Indemnified Parties (as applicable) from all liability and claims with respect to the Claim in question, in a form reasonably satisfactory to the Indemnified Party; and
(iii) The settlement does not involve, contain, or require any admission of fault, wrongdoing, violation of law, or liability by the Indemnified Party, whether express or implied.
(b) The Indemnified Party shall not settle, compromise, consent to any judgment with respect to, or agree to any disposition of a Claim for which it has sought indemnification under this Exhibit D without the prior written consent of the Indemnifying Party, which consent shall not be unreasonably withheld, conditioned, or delayed. Any settlement entered into by the Indemnified Party without the Indemnifying Party's prior written consent (where such consent is required under this Section 7.4(b)) shall release the Indemnifying Party from any indemnification obligation with respect to the amounts paid in such settlement, unless the Indemnifying Party's withholding of consent was unreasonable under the circumstances.
7.5 Cooperation. Each party shall cooperate fully and in good faith with the other party in the investigation, defense, and resolution of any Claim, including by:
(a) Making available, upon reasonable advance notice, all relevant personnel, including Investigators, sub-investigators, study coordinators, medical monitors, regulatory affairs personnel, and other individuals with knowledge of the facts underlying the Claim, for interviews, depositions, and testimony as may be reasonably required;
(b) Providing reasonable access to all relevant records, documents, and evidence in the possession, custody, or control of such party, including study records, source documents, case report forms, regulatory filings, adverse event reports, pharmacovigilance data, quality assurance audits, monitoring reports, and correspondence, subject to applicable privileges, confidentiality obligations, and privacy laws;
(c) Preserving all documents, records, and evidence that are relevant or potentially relevant to the Claim, in accordance with any applicable litigation hold or document preservation obligations; and
(d) Taking all reasonable steps to mitigate damages arising from or related to a Claim, including by promptly implementing corrective actions, providing appropriate medical care to affected Study Subjects, and cooperating with regulatory authorities as may be required.
The costs of cooperation (including travel expenses, employee time, and document production costs) shall be borne by the cooperating party, except that the Indemnifying Party shall reimburse the Indemnified Party for extraordinary out-of-pocket costs of cooperation that are incurred at the specific request of the Indemnifying Party or its counsel.
Section 8: Insurance
8.1 Sponsor Insurance Requirements. Penterra shall procure and maintain, at its own expense, clinical trial liability insurance (including products liability and completed operations coverage applicable to the CLARION trial) throughout the term of the Agreement and for a period of not less than three (3) years following the completion, expiration, or termination of the CLARION trial (including any extension or renewal thereof), with the following minimum coverage limits:
•  Per-occurrence limit: Twenty-Five Million Dollars ($25,000,000)
•  Annual aggregate limit: Seventy-Five Million Dollars ($75,000,000)
•  Subject-injury sublimit: Ten Million Dollars ($10,000,000) per occurrence / Fifty Million Dollars ($50,000,000) aggregate
As of the Effective Date of the Agreement, Penterra maintains clinical trial liability insurance with Briarcliff Mutual Insurance Company under Policy No. BM-CTL-2023-04182, with a policy period of April 1, 2023 through March 31, 2024, subject to annual renewal. The policy shall be issued on an occurrence-based form or, if on a claims-made form, shall include an extended reporting period (tail coverage) of not less than three (3) years following the completion or termination of the CLARION trial.
Penterra shall cause Veridian and each Participating Site to be named as additional insureds under its clinical trial liability policy with respect to Claims arising from or related to the CLARION trial. Penterra shall ensure that its clinical trial liability policy includes a waiver of subrogation in favor of the Site Indemnified Parties with respect to Claims covered by the indemnification provisions of this Exhibit D.
8.2 Site Insurance Requirements. Veridian and each Participating Site shall procure and maintain, at their own expense, general liability insurance and professional liability (medical malpractice) insurance with the following minimum coverage limits:
•  Per-occurrence limit: Five Million Dollars ($5,000,000)
•  Annual aggregate limit: Ten Million Dollars ($10,000,000)
Such coverage shall be maintained throughout the term of the Agreement and for a period of not less than three (3) years following the completion or termination of the CLARION trial at the applicable Participating Site. In the case of Participating Sites that are self-insured or that participate in state-sponsored risk pools or sovereign immunity programs, such self-insurance or risk pool participation shall be deemed to satisfy the requirements of this Section 8.2, provided that Veridian delivers to Penterra a written certification describing the applicable self-insurance program or risk pool and confirming that such program provides coverage at levels at least equivalent to the minimums set forth above.
Evidence of such coverage, in the form of certificates of insurance or other written documentation reasonably acceptable to Penterra, shall be provided to Penterra within fifteen (15) business days of execution of the Agreement and annually thereafter during the term of the Agreement and any applicable survival period.
8.3 Certificate Exchange. Each party shall deliver certificates of insurance (or, in the case of self-insured entities, written certifications of self-insurance) to the other party within fifteen (15) business days of execution of the Agreement and annually thereafter during the term of the Agreement and any applicable post-termination period. Each party shall provide the other party with thirty (30) days' prior written notice of any cancellation, non-renewal, or material reduction in coverage under any policy required to be maintained under this Section 8. For purposes of this Section 8.3, a "material reduction in coverage" shall mean any reduction in per-occurrence or aggregate limits, any increase in self-insured retention or deductible, any narrowing of covered risks, or any removal of additional insured status.
8.4 Insurance Not a Limitation on Indemnification. The parties expressly acknowledge and agree that the maintenance of insurance pursuant to this Section 8 shall not limit, cap, reduce, or otherwise affect the indemnification obligations of either party under this Exhibit D. The indemnification obligations set forth in Sections 2 and 5 are direct contractual obligations, independent of and in addition to any insurance coverage maintained by either party. In the event of any inconsistency between the terms, conditions, or limitations of any insurance policy and the indemnification obligations set forth in this Exhibit D, the indemnification obligations shall govern and control as between the parties hereto.
Section 9: Subrogation and Recovery
9.1 Subrogation Rights. To the extent that the Indemnifying Party pays or is obligated to pay Indemnified Losses to or on behalf of an Indemnified Party under this Exhibit D, the Indemnifying Party shall be subrogated to all rights, claims, causes of action, and remedies of the Indemnified Party against any third party (including, without limitation, manufacturers, suppliers, contractors, subcontractors, carriers, and insurers) with respect to the Indemnified Losses for which such indemnification has been or is being provided. The Indemnified Party shall execute and deliver all documents (including assignments, powers of attorney, and consents) and take all actions reasonably requested by the Indemnifying Party to enable the Indemnifying Party to pursue, prosecute, and enforce its subrogation rights, provided that the Indemnifying Party shall reimburse the Indemnified Party for any reasonable out-of-pocket costs incurred in connection therewith.
9.2 Third-Party Recoveries. If an Indemnified Party receives any recovery, reimbursement, offset, or payment from any third party (including, without limitation, an insurance carrier, a co-defendant in litigation, a settling party, or any other source) with respect to Indemnified Losses for which indemnification has been provided by the Indemnifying Party under this Exhibit D, the Indemnified Party shall promptly (and in any event within thirty (30) calendar days of receipt) reimburse the Indemnifying Party for the amount of such recovery, net of the reasonable costs of obtaining such recovery (including attorneys' fees and litigation costs), to the extent of the indemnification previously paid by the Indemnifying Party. The Indemnified Party shall provide the Indemnifying Party with prompt written notice of any such third-party recovery.
Section 10: Dispute Resolution
10.1 Incorporation by Reference. Any dispute, controversy, or claim arising under, out of, or relating to the indemnification provisions of this Exhibit D, or the breach, validity, or interpretation thereof (each, a "Dispute"), shall be resolved in accordance with the dispute resolution procedures set forth in Article XIV of the Agreement, as summarized below and as more fully set forth therein:
(1) Negotiation. In the first instance, designated senior representatives of the parties — specifically, the Vice President & General Counsel of Penterra (or his or her designee) and the Vice President, Legal & Compliance of Veridian (or his or her designee) — shall meet (in person or by videoconference) and negotiate in good faith for a period of thirty (30) calendar days from the date on which one party delivers to the other a written notice of the Dispute, with a view toward reaching a mutually acceptable resolution.
(2) Mediation. If the Dispute is not resolved through negotiation within the thirty (30) day period described above, either party may submit the Dispute to non-binding mediation under the Commercial Mediation Rules of the American Arbitration Association ("AAA") then in effect, to be conducted in Philadelphia, Pennsylvania or New York, New York (as agreed by the parties or, absent agreement, as selected by the AAA). The mediation shall continue for a period of sixty (60) calendar days from the date on which the mediation request is filed, unless extended by mutual agreement of the parties.
(3) Binding Arbitration. If the Dispute is not resolved through mediation within the sixty (60) day period described above, the Dispute shall be finally and exclusively resolved by binding arbitration administered by the AAA in accordance with the Commercial Arbitration Rules of the AAA then in effect, to be conducted in New York, New York, before a panel of three (3) arbitrators. Each party shall select one arbitrator, and the two party-selected arbitrators shall jointly select the third arbitrator, who shall serve as chair of the panel. Each arbitrator shall have substantial experience in clinical trial agreements, pharmaceutical litigation, or healthcare law. The arbitral panel shall have the authority to award compensatory damages, equitable relief, and reasonable attorneys' fees and costs, but shall not have the authority to award punitive or exemplary damages except to the extent such damages are required by applicable law. The decision of the arbitral panel shall be final and binding upon the parties, and judgment upon the award rendered by the arbitral panel may be entered in any court of competent jurisdiction.
10.2 Injunctive Relief. Notwithstanding the foregoing dispute resolution procedures, either party may seek temporary, preliminary, or permanent injunctive or other equitable relief in the state and federal courts located in New York County, New York, to prevent irreparable harm, preserve the status quo, or enforce obligations under this Exhibit D that are not susceptible to adequate remedy through monetary damages, pending the outcome of dispute resolution. The filing of an application for injunctive or equitable relief shall not constitute a waiver of either party's right to compel arbitration under Section 10.1(3).
10.3 Governing Law. This Exhibit D and the indemnification obligations, rights, and remedies set forth herein shall be governed by, and construed and interpreted in accordance with, the substantive laws of the State of New York, without regard to its conflict-of-laws principles or rules that would result in the application of the laws of any other jurisdiction. Each party irrevocably consents to the personal jurisdiction of the state and federal courts located in New York County, New York, for purposes of any proceeding seeking injunctive or equitable relief under Section 10.2.
Section 11: Regulatory Reporting and Safety Coordination
11.1 SAE Reporting. Nothing in this Exhibit D shall be construed to affect, delay, modify, or relieve the obligation of each Participating Site and each Investigator to report serious adverse events ("SAEs") in accordance with the timelines and procedures set forth in the Protocol, the Agreement, and Exhibit J to the Agreement (Safety Reporting Plan). Without limiting the generality of the foregoing, each Participating Site shall report all SAEs to Penterra and Meridian Contract Research Organization, Inc. within twenty-four (24) hours of the Investigator's or site's awareness of the SAE, regardless of whether the SAE is believed to be related to the Investigational Product, a study procedure, or a pre-existing condition. Penterra remains solely responsible for all IND safety reporting to the FDA under IND No. 157823, including seven (7) calendar day reports for fatal and life-threatening suspected adverse reactions and fifteen (15) calendar day reports for all other reportable safety events, in accordance with 21 C.F.R. § 312.32. The assertion or pendency of an indemnification claim under this Exhibit D shall not affect, delay, or excuse any party's regulatory safety reporting obligations.
11.2 Coordination with IRBs. Indemnification claims and Study-Related Injuries shall be reported to the applicable Institutional Review Board as required by 21 C.F.R. Part 56 and applicable institutional policies. For Participating Sites located in the Commonwealth of Pennsylvania, the applicable IRB is the Graystone University Institutional Review Board (IRB Registration: IRB00012847; FWA: FWA00009831). For all non-Pennsylvania Participating Sites, the applicable IRB is the Veridian Central IRB, unless the applicable Individual Site Agreement designates a different local or central IRB. Each Participating Site shall comply with all applicable IRB reporting requirements for unanticipated problems involving risks to subjects or others, serious or continuing noncompliance, and other reportable events, in accordance with 21 C.F.R. §§ 56.108(b) and 312.66, FDA Guidance for Clinical Investigators, Sponsors, and IRBs on Adverse Event Reporting (December 2012, as updated), and the policies of the applicable IRB.
Section 12: Term and Survival
12.1 Effective Period. The indemnification obligations, medical care cost obligations, and all other rights and obligations set forth in this Exhibit D shall become effective on the Effective Date of the Agreement (June 28, 2023) and shall remain in full force and effect throughout the term of the Agreement and for the survival periods specified in this Section 12. The indemnification obligations set forth herein shall survive the expiration or termination of the Agreement for any reason, including termination for convenience, termination for cause, termination by mutual agreement, or termination due to a regulatory action.
12.2 Survival Period. The following survival periods shall apply:
(a) Sponsor's Obligations. Sponsor's indemnification obligations under Section 2 and Sponsor's medical care cost obligations under Section 4 shall survive for a period of ten (10) years following the later of: (i) the date of completion or termination of the CLARION trial (including the completion or termination of any extension study, long-term follow-up study, or ot

EXHIBIT D

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