Contract analysis

ARTICLE 1 — DEFINITIONS AND INTERPRETATION

Section 1.1 — Definitions. All capitalized terms used but not otherwise defined in this Individual Site Agreement shall have the meanings ascribed to such terms in the MCTA. For purposes of clarity and convenience, the following defined terms are reiterated or supplemented herein: (a) "Central Laboratory" means Northbridge Bioanalytical Laboratories, Inc., the Sponsor's designated central laboratory for the CLARION t

Section 1.2 — Interpretation. In this Agreement, unless the context otherwise requires: (a) the singular includes the plural and vice versa; (b) references to "Articles," "Sections," "Schedules," and "Exhibits" are to the articles, sections, schedules, and exhibits of or to this Agreement unless otherwise specified; (c) the words "include," "includes," and "including" shall be deemed to be followed by the phrase "wit

Section 1.3 — Order of Precedence. In the event of any conflict or inconsistency among the documents comprising the agreement between the Parties, the following order of precedence shall apply, from highest to lowest priority: (a) this Individual Site Agreement (with respect to Site-specific matters only); (b) the MCTA; (c) the Protocol; and (d) the Exhibits and Schedules to the MCTA and this Agreement. For the avoid

ARTICLE 2 — INCORPORATION OF MCTA TERMS

Section 2.1 — Full Incorporation. All terms, conditions, obligations, rights, representations, warranties, covenants, and remedies set forth in the MCTA are hereby incorporated into this Individual Site Agreement by reference in their entirety and shall be binding on the Site, the Site Principal Investigator, and all site personnel as though the Site were an original signatory party to the MCTA. By executing this Agr

Section 2.2 — MCTA Exhibits and Schedules Applicable to Site. The following Exhibits and Schedules to the MCTA are hereby incorporated into this Individual Site Agreement by reference and are applicable to the Site: (a) Exhibit A — Protocol Synopsis (Protocol PPC-4871-III, CLARION); (b) Exhibit B — Budget and Payment Schedule, as supplemented and further specified by Schedule B to this Agreement with respect to Site-

ARTICLE 3 — SCOPE OF WORK AND SITE OBLIGATIONS

Section 3.1 — Conduct of the Study. The Site shall conduct Protocol PPC-4871-III (CLARION) in strict accordance with the Protocol and all amendments thereto, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guideline for Good Clinical Practice, ICH E6(R2) (the "ICH GCP Guidelines"), all applicable regulations of the United States Food and Drug Administration (the

Section 3.2 — Site Principal Investigator. The Site Principal Investigator designated in Schedule A to this Agreement shall be responsible for the overall medical conduct of the trial at the Site, including but not limited to: (a) obtaining and documenting informed consent from each prospective subject in accordance with 21 C.F.R. Part 50 and the requirements of the Veridian Central IRB; (b) ensuring the safety, welf

Section 3.3 — Sub-Investigators and Site Personnel. All sub-investigators and study coordinators involved in the conduct of Protocol PPC-4871-III at the Site must be identified on the FDA Form 1572 filed by the Site Principal Investigator and must be qualified by education, training, and experience to perform their respective delegated trial-related duties. The Site shall maintain a current and accurate delegation of

Section 3.4 — IRB Oversight. The Site shall rely on the Veridian Central IRB as its IRB of record for Protocol PPC-4871-III. The Site acknowledges that the Veridian Central IRB will serve as the reviewing IRB responsible for the initial and continuing review of the Protocol, informed consent documents, recruitment materials, and all other study-related materials requiring IRB review and approval. An IRB Authorization

Section 3.5 — Approved Subcontractors. The Site acknowledges and agrees that the following approved subcontractors have been engaged by the Sponsor to provide services in connection with the CLARION trial, and the Site shall cooperate with such subcontractors in the performance of their respective duties: (a) Meridian Contract Research Organization, Inc. (the "CRO"), which will provide clinical monitoring services (i

Section 3.6 — Study Timeline. The projected timelines for the CLARION trial are as follows: (a) Target First Patient In (FPI) across all sites: August 14, 2023; (b) Projected enrollment period: Forty-two (42) months from FPI (projected Last Patient In: February 2027); (c) Estimated total study duration: Sixty (60) months from FPI (projected study completion, including final database lock and study report: August 2028

ARTICLE 4 — FINANCIAL TERMS AND PAYMENT

Section 4.1 — Budget. The Site shall be compensated for the conduct of Protocol PPC-4871-III in accordance with the budget set forth in Schedule B to this Agreement, which is consistent with and supplements the budget framework established in Exhibit B to the MCTA. The total aggregate budget for the CLARION trial across all thirty-eight (38) participating Veridian Health Research Network sites is Eighty Million Dolla

Section 4.2 — Start-Up Fees. The Sponsor shall pay to the Site a one-time start-up fee of Seventy-Five Thousand Dollars ($75,000.00) to defray costs associated with Site activation, including regulatory submissions, staff training, equipment calibration, pharmacy set-up, and other Site readiness activities. The start-up fee shall be paid in two (2) equal installments as follows: (a) Fifty percent (50%) of the start-u

Section 4.3 — Per-Patient Site Fees. The Sponsor shall pay to the Site a per-patient fee of Fifty-Two Thousand Dollars ($52,000.00) for each subject who is screened and enrolled (randomized) at the Site, payable on a milestone-based payment schedule as follows: (a) Randomization Milestone: Twenty-five percent (25%) of the per-patient fee (Thirteen Thousand Dollars ($13,000.00)) shall be payable upon the randomization

Section 4.4 — Annual Site Maintenance Fees. The Sponsor shall pay to the Site an annual site maintenance fee of Forty Thousand Dollars ($40,000.00) per year to cover ongoing costs associated with the maintenance of the Site's participation in the Study, including but not limited to staff retention, equipment maintenance, regulatory compliance, record storage, and continuing education. The annual site maintenance fee

Section 4.5 — Payment Terms. All payments under this Agreement shall be made within forty-five (45) calendar days from the Sponsor's receipt of a proper and complete invoice submitted by the Site through the Network. Invoices shall include: the Site number (004), the Protocol number (PPC-4871-III), the applicable milestone or fee description, the period of service, the amount invoiced, and supporting documentation as

Section 4.6 — Fair Market Value. The Site and the Site Principal Investigator represent and warrant that all compensation payable under this Agreement reflects fair market value for the services to be rendered and the time, effort, and expertise required, and that such compensation has been determined through arm's-length negotiations and does not take into account the volume or value of any referrals of patients, su

Section 5.1 — Sponsor Indemnification of Site and Investigators. Subject to the terms and conditions of this Article 5 and the provisions of Exhibit D to the MCTA, the Sponsor shall defend, indemnify, and hold harmless Cedar Falls University Hospital, its officers, directors, trustees, employees, agents, the Site Principal Investigator, all sub-investigators, and all site staff (collectively, the "Site Indemnified Pa

Section 5.2 — Carve-Outs from Sponsor Indemnification. Notwithstanding the foregoing, the Sponsor's indemnification obligations under Section 5.1 shall not apply to the extent that Losses arise from or are attributable to: (i) The negligence, gross negligence, or willful misconduct of the Site, the Site Principal Investigator, any sub-investigator, or any site personnel in the conduct of the Study; (ii) Any deviation

Section 5.3 — Subject Medical Care. In the event that a Study subject experiences a study-related injury (defined as an injury that is directly and proximately caused by the administration of the Investigational Product in accordance with the Protocol or by a study-required procedure), the Sponsor shall cover the reasonable and customary medical costs for the diagnosis and treatment of such injury to the extent that

Section 5.4 — Site Indemnification of Sponsor. Subject to the terms and conditions of this Article 5 and the provisions of Exhibit D to the MCTA, Cedar Falls University Hospital shall defend, indemnify, and hold harmless the Sponsor, its officers, directors, employees, agents, and affiliates (collectively, the "Sponsor Indemnified Parties") from and against any and all Losses arising from or related to: (a) The negli

Section 5.5 — Notice Requirements. Any Party seeking indemnification under this Article 5 (an "Indemnified Party") shall provide written notice to the Party from whom indemnification is sought (the "Indemnifying Party") within thirty (30) calendar days of becoming aware of any claim, demand, action, suit, or proceeding for which indemnification may be sought under this Agreement. Such notice shall include a reasonabl

Section 5.6 — Defense and Settlement. The rights and obligations of the parties with respect to the defense and settlement of indemnified claims, including the Indemnifying Party's right to assume the defense of any claim, the Indemnified Party's right to participate in the defense at its own expense, the Indemnifying Party's authority to settle claims (subject to the Indemnified Party's consent, not to be unreasonab

Section 6.1 — Sponsor Insurance. The Sponsor represents and warrants that it maintains clinical trial liability insurance coverage with Briarcliff Mutual Insurance Company, under Policy Number BM-CTL-2023-04182, with the following coverage limits: (a) Per-occurrence limit: Twenty-Five Million Dollars ($25,000,000.00); (b) Aggregate limit: Seventy-Five Million Dollars ($75,000,000.00); (c) Subject-injury sublimit: Ten

Section 6.2 — Site Insurance. Cedar Falls University Hospital shall maintain, at its own expense, the following minimum insurance coverages throughout the duration of the Study and for a period of not less than three (3) years following the completion or termination of the Study at the Site: (a) Commercial general liability insurance with limits of not less than Five Million Dollars ($5,000,000.00) per occurrence and

Section 6.3 — Certificate Exchange. The Sponsor and the Site shall exchange certificates of insurance within fifteen (15) business days of the Execution Date of this Agreement and annually thereafter for the duration of the Study. Additional certificate exchanges shall occur promptly upon the renewal, replacement, or material modification of any insurance policy required under this Article 6. All certificates of insu

ARTICLE 7 — CONFIDENTIALITY AND DATA PROTECTION

Section 7.1 — Confidentiality Obligations. The Site shall comply with all confidentiality obligations set forth in Exhibit F to the MCTA. Without limiting the generality of the foregoing, the Site shall hold in strict confidence and shall not use (except in connection with the conduct of the Study) or disclose to any third party, without the prior written consent of the Sponsor, any Confidential Information (as defin

Section 7.2 — Permitted Disclosures. Notwithstanding the foregoing, the confidentiality obligations under this Article 7 shall not apply to the disclosure of Confidential Information: (a) To the Veridian Central IRB or any local institutional review board, to the extent necessary for the IRB's review and oversight of the Study; (b) To the FDA or any other governmental or regulatory authority, to the extent required b

Section 7.3 — HIPAA Compliance. The Site shall comply with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as amended, and its implementing regulations at 45 C.F.R. Parts 160 and 164, including the Standards for Privacy of Individually Identifiable Health Information (the "Privacy Rule") and the Security Standards for the Protection of Electronic Protected Health Information (the "Security Ru

ARTICLE 8 — DATA OWNERSHIP AND INTELLECTUAL PROPERTY

Section 8.1 — Clinical Trial Data Ownership. The Sponsor shall retain exclusive ownership of all clinical trial data, including but not limited to case report forms (whether in paper or electronic format), data entered into the EDC Platform, laboratory data generated by the Central Laboratory, safety data, efficacy data, pharmacokinetic and pharmacodynamic data, biomarker data, and all analyses, reports, and database

Section 8.2 — Source Document Retention. The Site shall retain all source documents, study records, informed consent forms, IRB correspondence, regulatory submissions, Investigational Product accountability records, and other documentation relating to the conduct of the Study at the Site for a minimum period of fifteen (15) years following the completion of the Study or the termination of this Agreement, whichever is

Section 8.3 — Pre-Existing intellectual Property. Each Party retains all right, title, and interest in and to its pre-existing intellectual property, including patents, patent applications, trade secrets, know-how, copyrights, trademarks, and other proprietary rights that existed prior to the Execution Date of this Agreement or that are developed independently of the Study. Nothing in this Agreement shall be construe

Section 8.4 — Publication Rights. The Site Principal Investigator and sub-investigators shall have the right to publish or present the results of the Study, subject to the following conditions: (a) Prior to submission of any manuscript, abstract, presentation, or other publication (collectively, a "Publication") for external dissemination, the Site Principal Investigator shall submit a complete copy of the proposed P

Section 9.1 — SAE Reporting. The Site shall report all serious adverse events ("SAEs") occurring in Study subjects enrolled at the Site to the Sponsor and to the CRO (Meridian Contract Research Organization, Inc.) within twenty-four (24) hours of the Site's awareness of the event. For purposes of this Agreement, a "serious adverse event" is any adverse event that results in death, is life-threatening, requires inpati

Section 9.2 — IND Safety Reports. The Sponsor, as the holder of IND 157823 for penterafenib, is solely responsible for the preparation, submission, and distribution of IND safety reports to the FDA in accordance with 21 C.F.R. § 312.32, including: (a) telephone or facsimile reports to the FDA within seven (7) calendar days of initial receipt of information for any adverse event that is both serious and unexpected and

Section 9.3 — Coordination with CRO. All safety data management activities, including the receipt, processing, coding, assessment, and reporting of adverse events and SAEs, shall be coordinated by and through Meridian Contract Research Organization, Inc., acting on behalf of the Sponsor, in accordance with the safety reporting procedures set forth in Exhibit J to the MCTA and the pharmacovigilance agreement between t

ARTICLE 10 — REGULATORY COMPLIANCE REPRESENTATIONS AND COVENANTS

Section 10.1 — Regulatory Compliance. The Site represents and warrants that it is, and covenants that it shall remain throughout the term of this Agreement, in compliance with all applicable federal, state, and local laws, rules, and regulations governing the conduct of clinical trials and the use of investigational products, including without limitation: (a) The Federal Food, Drug, and Cosmetic Act, as amended, and

Section 10.2 — Financial Disclosure. The Site Principal Investigator and all sub-investigators listed on the FDA Form 1572 shall complete and submit to the Sponsor Financial Disclosure Certifications in accordance with 21 C.F.R. Part 54, disclosing all financial interests, significant payments, equity interests, and proprietary interests (as those terms are defined in 21 C.F.R. § 54.2) held by the investigator, the i

Section 10.3 — Debarment and Exclusion. The Site represents and warrants that neither Cedar Falls University Hospital nor any of its officers, directors, employees, investigators, sub-investigators, or site staff members who will be involved in the conduct of the Study is currently, or has ever been: (a) debarred, suspended, proposed for debarment, or otherwise ineligible to participate in Federal procurement or non-

ARTICLE 11 — TERM, TERMINATION, AND WIND-DOWN

Section 11.1 — Term. This Individual Site Agreement shall become effective upon the later of (a) the date on which this Agreement is fully executed by all Parties (the "Execution Date") or (b) the Effective Date of the MCTA (July 18, 2023), and shall remain in effect until the earlier of: (i) the completion of all Study activities at the Site, including the collection and entry of all data, resolution of all data que

Section 11.2 — Termination. This Individual Site Agreement may be terminated under the following circumstances: (a) Termination by the Sponsor: The Sponsor may terminate this Agreement, with or without cause, upon ninety (90) days' prior written notice to the Site and the Network. In the event of termination by the Sponsor, the wind-down provisions of Section 11.2(d) shall apply. (b) Termination by the Site: The Site

Section 11.3 — Effect of Termination. The expiration or termination of this Agreement shall not relieve any Party of any obligations that have accrued prior to the effective date of such expiration or termination, including without limitation: (a) indemnification obligations under Article 5; (b) confidentiality obligations under Article 7; (c) data ownership rights under Article 8; (d) record retention requirements u

ARTICLE 12 — DISPUTE RESOLUTION

Section 12.1 — Governing Law. This Individual Site Agreement and the MCTA shall be governed by and construed in accordance with the laws of the State of New York, without regard to its conflict of laws principles. The Parties agree that the United Nations Convention on Contracts for the International Sale of Goods shall not apply to this Agreement.

Section 12.2 — Escalation Procedure. Any dispute, controversy, or claim arising out of or relating to this Agreement, the MCTA, or the breach, termination, or validity thereof (a "Dispute") shall be resolved in accordance with the following escalation procedure: (a) Negotiation. The Parties shall first attempt to resolve the Dispute through good-faith negotiations between designated senior representatives of each Par

Section 12.3 — Injunctive Relief. Notwithstanding the foregoing, either Party may seek injunctive or other equitable relief from the state and federal courts located in the County of New York, State of New York, to prevent irreparable harm pending the outcome of the dispute resolution procedures set forth in this Article 12. Each Party hereby consents to the exclusive jurisdiction and venue of such courts for purpose