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Contract analysis / exhibit-c-form-site-joinder.docx
exhibit-c-form-site-joinder.docx
High · 11
Medium · 8
Standard · 3
1. Penterra Pharmaceuticals Corp., a Delaware corporation with its principal offices at 20
1. Penterra Pharmaceuticals Corp., a Delaware corporation with its principal offices at 200 Biopharma Boulevard, Suite 1400, Princeton, NJ 08540 ("Sponsor");
2. Veridian Health Research Network, Inc., a Delaware 501(c)(3) corporation with its princ
2. Veridian Health Research Network, Inc., a Delaware 501(c)(3) corporation with its principal offices at 750 Research Parkway, 8th Floor, Philadelphia, PA 19104 ("Network"); and 3. \\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\ [Full Legal Name of Site Institution], a \\\\\\\\\\\\\\\\ [state] \\\\\\\\\\\\\\\\ [entity type] with its principal offices at \\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\ [address] (the
ARTICLE 1 — DEFINITIONS AND INCORPORATION BY REFERENCE
ARTICLE 1 — DEFINITIONS AND INCORPORATION BY REFERENCE
Section 1.1 — Definitions
Section 1.1 — Definitions All capitalized terms used but not otherwise defined in this Site Agreement shall have the meanings ascribed to them in the MCTA. In addition to the definitions set forth in the MCTA, the following terms shall have the meanings set forth below when used in this Site Agreement: (a) "IRB" means the Institutional Review Board or Ethics Committee identified in Site-Specific Schedule C attached h
Section 1.2 — Incorporation of MCTA
High
⚑ Indemnity / guarantee obligation
Section 1.2 — Incorporation of MCTA The terms and conditions of the MCTA, including all Exhibits and Schedules thereto (Exhibits A through K and Schedule 1), are hereby incorporated by reference into this Site Agreement as if fully set forth herein. The Site acknowledges that it has received and reviewed a complete copy of the MCTA and all Exhibits and Schedules thereto. In the event of any conflict or inconsistency
ARTICLE 2 — JOINDER AND ASSUMPTION OF OBLIGATIONS
ARTICLE 2 — JOINDER AND ASSUMPTION OF OBLIGATIONS
Section 2.1 — Joinder
Section 2.1 — Joinder By executing this Site Agreement, the Site hereby agrees to be bound by and subject to all terms, conditions, representations, warranties, covenants, and obligations of a "Participating Site" or "Site" under the MCTA, with the same force and effect as if the Site were an original signatory thereto. This Site Agreement constitutes a joinder to the MCTA, and the Site shall be deemed a party to the
Section 2.2 — Assumption of Obligations
Medium
⚑ Liability cap to check against exposure
Section 2.2 — Assumption of Obligations The Site hereby assumes all obligations of a Participating Site under the MCTA, including but not limited to the following: (a) Protocol Compliance. Conduct of the Protocol in strict compliance with the approved protocol document (including all amendments thereto approved by the IRB and Sponsor), applicable federal, state, and local law, Good Clinical Practice as set forth in I
Section 2.3 — Network Responsibility
Medium
⚑ Liability cap to check against exposure
Section 2.3 — Network Responsibility The Network remains jointly responsible with the Site for the performance of obligations under the MCTA, subject to the terms, conditions, and limitations set forth in the MCTA. The Site acknowledges that the Network serves as the administrative and coordinating entity for all participating sites within the Veridian Health Research Network and that the Network's obligations under
ARTICLE 3 — PRINCIPAL INVESTIGATOR
ARTICLE 3 — PRINCIPAL INVESTIGATOR
Section 3.1 — Designation of Principal Investigator
Section 3.1 — Designation of Principal Investigator The Site hereby designates the individual identified in Site-Specific Schedule B attached hereto as the Principal Investigator for the conduct of the Protocol at the Site. The PI shall have overall responsibility for the proper conduct of the Protocol at the Site, including responsibility for subject safety, data integrity, compliance with the Protocol and applicabl
Section 3.2 — Sub-Investigators
Section 3.2 — Sub-Investigators Site-Specific Schedule B shall include a complete list of all sub-investigators who are authorized to conduct Protocol-related activities at the Site under the supervision of the PI. Each sub-investigator must meet the following requirements: (a) Be listed on the PI's FDA Form 1572; (b) Execute the Investigator Undertaking in the form attached as Exhibit I to the MCTA; (c) Provide a cu
Section 3.3 — Replacement of Principal Investigator
Section 3.3 — Replacement of Principal Investigator The Site may not replace the PI without the prior written consent of Sponsor, which consent shall not be unreasonably withheld, conditioned, or delayed. If the PI becomes unable or unwilling to continue serving as the principal investigator for the Protocol at the Site, whether due to illness, departure from the Institution, regulatory action, loss of medical licens
Section 3.4 — Financial Disclosure
Section 3.4 — Financial Disclosure The PI and all sub-investigators listed on the FDA Form 1572 must complete and submit financial disclosure certifications in the form required under 21 C.F.R. Part 54, as set forth in the template referenced in the MCTA. Such certifications must be submitted: (a) Prior to Site Activation; (b) Annually thereafter, within thirty (30) days following each anniversary of the Site Activat
ARTICLE 4 — SITE-SPECIFIC BUDGET AND PAYMENT
ARTICLE 4 — SITE-SPECIFIC BUDGET AND PAYMENT
Section 4.1 — Budget Allocation
Standard
⚑ Commercial term
Section 4.1 — Budget Allocation The site-specific budget for the Site is set forth in Site-Specific Schedule D attached hereto, which budget is based upon and consistent with the Budget and Payment Schedule attached as Exhibit B to the MCTA. The total per-patient fee is Fifty-Two Thousand Dollars ($52,000) per subject (screen-to-completion), payable in four (4) milestone-based installments as follows: (i) Milestone 1
Section 4.2 — Start-Up Fees
Standard
⚑ Commercial term
Section 4.2 — Start-Up Fees The Site shall receive a non-refundable start-up fee of Seventy-Five Thousand Dollars ($75,000), payable in two (2) installments as follows: (i) Thirty-Seven Thousand Five Hundred Dollars ($37,500) payable upon Site Activation; and (ii) Thirty-Seven Thousand Five Hundred Dollars ($37,500) payable upon enrollment (randomization) of the first subject at the Site. The start-up fee is intended
Section 4.3 — Annual Site Maintenance Fees
Medium
⚑ Liability cap to check against exposure
Section 4.3 — Annual Site Maintenance Fees The Site shall receive an annual site maintenance fee of Forty Thousand Dollars ($40,000), payable annually in advance on each anniversary of the Site Activation Date, for the duration of the Site's participation in the Protocol. The estimated average duration of site participation is three and one-half (3.5) years per site, although actual duration may vary depending on enr
Section 4.4 — Investigator Grants
Section 4.4 — Investigator Grants Investigator grants for publication and academic support shall be disbursed in accordance with the terms set forth in the MCTA and Exhibit G thereto. The total investigator grant pool across all participating sites is One Million Five Hundred Thousand Dollars ($1,500,000). Grants shall be disbursed upon acceptance of manuscripts based on Protocol data for publication in peer-reviewed
Section 4.5 — Invoicing and Payment Terms
Standard
⚑ Commercial term
Section 4.5 — Invoicing and Payment Terms The Site shall submit invoices to Sponsor (or its designee, currently Meridian Contract Research Organization, Inc.) in accordance with the invoicing procedures specified in Exhibit B to the MCTA. All invoices shall be submitted in writing (electronic submission is acceptable) and shall include the following information: (a) The Protocol Number (PPC-4871-III); (b) The Site Nu
Section 4.6 — Taxes
High
⚑ Non-compete / exclusivity restraint
Section 4.6 — Taxes All payments under this Site Agreement and the MCTA are exclusive of applicable taxes. The Site shall be solely responsible for any federal, state, or local income, sales, use, excise, or other taxes arising from or related to payments received under this Site Agreement, except to the extent that such taxes are required by law to be withheld by Sponsor. If the Site is a tax-exempt organization und
Section 5.1 — Sponsor Indemnification of Site
High
⚑ Indemnity / guarantee obligation
Section 5.1 — Sponsor Indemnification of Site Sponsor's indemnification obligations with respect to the Site, its PI, sub-investigators, officers, directors, employees, agents, and site staff are as set forth in Exhibit D to the MCTA, which provisions are incorporated herein by reference in their entirety and shall apply to the Site as if the Site were specifically named therein as an indemnified party. Without limit
Section 5.2 — Site Indemnification of Sponsor
High
⚑ Indemnity / guarantee obligation
Section 5.2 — Site Indemnification of Sponsor The Site, jointly and severally with the Network (to the extent provided in the MCTA), shall defend, indemnify, and hold harmless Sponsor, its officers, directors, employees, agents, and contractors (collectively, the "Sponsor Indemnitees") from and against any and all claims, demands, actions, suits, proceedings, losses, damages, liabilities, costs, and expenses (includi
Section 5.3 — Notice of Claims
High
⚑ Indemnity / guarantee obligation
Section 5.3 — Notice of Claims The indemnified party shall provide written notice to the indemnifying party of any claim, demand, action, suit, or proceeding for which indemnification is sought under this Article 5 within thirty (30) calendar days of the indemnified party's becoming aware of such claim. Such notice shall include a reasonably detailed description of the claim and the factual basis therefor, together w
Section 5.4 — Defense and Settlement
High
⚑ Indemnity / guarantee obligation
Section 5.4 — Defense and Settlement The procedures governing the defense, management, and settlement of indemnified claims shall be as set forth in Exhibit D to the MCTA, which procedures are incorporated herein by reference. Without limiting the foregoing, no party shall settle any claim for which indemnification is sought under this Article 5 without the prior written consent of the indemnifying party, which conse
Section 6.1 — Sponsor Insurance
Section 6.1 — Sponsor Insurance Sponsor represents and warrants that it maintains clinical trial liability insurance coverage through Briarcliff Mutual Insurance Company under Policy No. BM-CTL-2023-04182, with the following minimum coverage limits: (a) Per-occurrence limit: Twenty-Five Million Dollars ($25,000,000); (b) Aggregate limit: Seventy-Five Million Dollars ($75,000,000); (c) Subject-injury sublimit: Ten Mil
Section 6.2 — Site Insurance
Section 6.2 — Site Insurance The Site shall obtain and maintain, at its own expense, general liability and professional liability (medical malpractice) insurance coverage with minimum limits of not less than: (a) Five Million Dollars ($5,000,000) per occurrence; and (b) Ten Million Dollars ($10,000,000) in the aggregate. Such coverage shall be maintained throughout the term of this Site Agreement and for a period of
Section 6.3 — Exchange of Certificates
Section 6.3 — Exchange of Certificates The Parties shall exchange certificates of insurance within fifteen (15) business days of execution of this Site Agreement and annually thereafter during the term of the Protocol. Each Party shall promptly notify the other Parties of any material changes to its insurance coverage, including any reduction in limits, cancellation, or non-renewal.
Section 7.1 — IRB of Record
Section 7.1 — IRB of Record The IRB of record for the conduct of the Protocol at the Site is identified in Site-Specific Schedule C attached hereto. The Site shall ensure that the IRB of record has appropriate registration with the Office for Human Research Protections (OHRP) and, if applicable, with the FDA, and that the IRB of record has a current Federalwide Assurance (FWA) on file with OHRP. If the Site relies on
Section 7.2 — Continuing IRB Approval
Section 7.2 — Continuing IRB Approval The Site shall maintain continuous, uninterrupted IRB approval for the Protocol throughout the conduct of study activities at the Site. The Site shall be responsible for the timely submission of all materials required by the IRB of record, including without limitation: (a) Protocol amendments (including all Sponsor-initiated and investigator-initiated amendments); (b) Revised inf
Section 7.3 — Informed Consent
Section 7.3 — Informed Consent The Site shall obtain documented informed consent from each study subject prior to the performance of any Protocol-specific procedures, in accordance with 21 C.F.R. Part 50, ICH Guideline E6(R2), and applicable state law. The informed consent process shall be conducted using the IRB-approved informed consent form, which shall include all elements of informed consent required by 21 C.F.R
ARTICLE 8 — TERM AND TERMINATION
ARTICLE 8 — TERM AND TERMINATION
Section 8.1 — Term
Section 8.1 — Term This Site Agreement shall become effective upon execution by all three Parties (Sponsor, Network, and Site) and shall remain in full force and effect until the earliest of the following: (a) Completion of all study activities and fulfillment of all obligations at the Site under the Protocol, including the submission of all final data, resolution of all data queries, return or destruction of all unu
Section 8.2 — Termination for Convenience by Sponsor
High
⚑ Unilateral / for-convenience termination
Section 8.2 — Termination for Convenience by Sponsor Sponsor may terminate this Site Agreement, in whole or in part, for any reason or no reason, upon sixty (60) days' prior written notice to the Site and the Network. In the event of termination for convenience by Sponsor, Sponsor shall compensate the Site in accordance with Section 8.5(d) below.
Section 8.3 — Termination for Cause
Section 8.3 — Termination for Cause Either Party may terminate this Site Agreement immediately upon written notice to the other Parties if any of the following events occurs: (a) A Party materially breaches any provision of this Site Agreement or the MCTA and fails to cure such breach within thirty (30) calendar days after receipt of written notice specifying the breach in reasonable detail; (b) A Party becomes subje
Section 8.4 — Termination by Site
Medium
⚑ Notice / time limit to track
Section 8.4 — Termination by Site The Site may terminate this Site Agreement upon ninety (90) days' prior written notice to Sponsor and the Network, provided that the Site complies with all wind-down obligations set forth in Section 8.5 below and cooperates with Sponsor and the Network to ensure the safety and continuity of care for all subjects enrolled at the Site. The Site's notice of termination shall include a d
Section 8.5 — Wind-Down Obligations
Medium
⚑ Forum / governing law
Section 8.5 — Wind-Down Obligations Upon any termination or expiration of this Site Agreement, regardless of the reason therefor, the Site shall comply with a wind-down period of one hundred twenty (120) days (or such shorter period as may be mutually agreed upon by the Parties in writing) during which the following obligations shall apply: (a) Subject Transition and Continuity of Care. Subjects who are in active tre
Section 8.6 — Survival
High
⚑ Indemnity / guarantee obligation
Section 8.6 — Survival The following provisions of this Site Agreement (and the corresponding provisions of the MCTA) shall survive any termination or expiration of this Site Agreement and shall continue in full force and effect in accordance with their respective terms: Article 5 (Indemnification), Article 6 (Insurance), confidentiality obligations (Exhibit F to the MCTA, which shall survive for a period of ten (10)
ARTICLE 9 — DATA OWNERSHIP AND RECORDS
ARTICLE 9 — DATA OWNERSHIP AND RECORDS
Section 9.1 — Ownership of Clinical Trial Data
High
⚑ Non-compete / exclusivity restraint
Section 9.1 — Ownership of Clinical Trial Data Sponsor retains exclusive ownership of all clinical trial data, including but not limited to all case report form data, electronic data capture records, laboratory data, biomarker data, pharmacokinetic data, imaging data, patient-reported outcome data, and any other data generated at the Site in connection with the conduct of the Protocol, consistent with the applicable
Section 9.2 — Electronic Data Capture
Section 9.2 — Electronic Data Capture The Site shall enter all study data into the electronic data capture (EDC) system provided by Pinnacle Data Solutions, Inc., in accordance with Sponsor's data management plan and all applicable requirements of 21 C.F.R. Part 11 (Electronic Records; Electronic Signatures). The Site shall ensure that all personnel who access or enter data into the EDC system have received appropria
Section 9.3 — Record Retention
Section 9.3 — Record Retention The Site shall retain all source documents, medical records, study files, regulatory correspondence, IRB documentation, pharmacy records, informed consent forms, and all other records related to the conduct of the Protocol at the Site for a minimum period of fifteen (15) years following study completion at the Site, or for such longer period as may be required by applicable federal, sta
ARTICLE 10 — PUBLICATION RIGHTS
ARTICLE 10 — PUBLICATION RIGHTS
Section 10.1 — Investigator Publication Rights
Medium
⚑ Confidentiality undertaking
Section 10.1 — Investigator Publication Rights The PI and sub-investigators at the Site may publish or present the results of the Protocol, subject to and in accordance with the publication provisions set forth in Exhibit G to the MCTA. The Site acknowledges and agrees that the right to publish is subject to the following conditions and restrictions: (a) Pre-Submission Review. Prior to submission of any manuscript, a
ARTICLE 11 — REGULATORY COMPLIANCE REPRESENTATIONS
ARTICLE 11 — REGULATORY COMPLIANCE REPRESENTATIONS
Section 11.1 — Site Representations
Medium
⚑ Forum / governing law
Section 11.1 — Site Representations The Site hereby represents and warrants to Sponsor and the Network, as of the Site Agreement Effective Date and on a continuing basis throughout the term of this Site Agreement, as follows: (a) Organization and Good Standing. The Site is duly organized, validly existing, and in good standing under the laws of its state of organization, and has the legal capacity and authority to co
ARTICLE 12 — APPROVED SUBCONTRACTORS AND CRO
ARTICLE 12 — APPROVED SUBCONTRACTORS AND CRO
Section 12.1 — Approved Third Parties
Section 12.1 — Approved Third Parties The Site acknowledges and agrees that Sponsor has engaged the following approved subcontractors for the conduct of the Protocol, as listed in Exhibit K to the MCTA: (a) Meridian Contract Research Organization, Inc. — CRO services including clinical monitoring, data management, safety reporting, pharmacovigilance, biostatistics, and regulatory support. Principal offices at 9200 Co
Section 12.2 — Site Subcontracting
High
⚑ Indemnity / guarantee obligation
Section 12.2 — Site Subcontracting The Site shall not subcontract, delegate, or assign any of its obligations under this Site Agreement or the MCTA to any third party without the prior written consent of Sponsor, which consent may be granted or withheld in Sponsor's sole discretion. Any approved subcontract shall be in writing and shall contain terms and conditions consistent with and no less restrictive than those c
ARTICLE 13 — CONFIDENTIALITY
Medium
⚑ Notice / time limit to track
ARTICLE 13 — CONFIDENTIALITY The confidentiality provisions set forth in Exhibit F to the MCTA are incorporated herein by reference in their entirety and shall apply to the Site, the PI, all sub-investigators, and all employees, agents, and representatives of the Site as if each were a direct party to Exhibit F. The term of the confidentiality obligations is ten (10) years from the date of disclosure of any Confident
ARTICLE 14 — DISPUTE RESOLUTION
High
⚑ Non-compete / exclusivity restraint
ARTICLE 14 — DISPUTE RESOLUTION This Site Agreement shall be governed by and construed in accordance with the laws of the State of New York, without giving effect to any choice-of-law or conflict-of-law rules or provisions that would cause the application of the laws of any other jurisdiction. The Parties agree that the United Nations Convention on Contracts for the International Sale of Goods shall not apply to this
ARTICLE 15 — NOTICES
ARTICLE 15 — NOTICES All notices, requests, demands, consents, approvals, and other communications required or permitted under this Site Agreement shall be in writing and shall be delivered to the Parties at the following addresses (or at such other address as a Party may designate in writing to the other Parties from time to time): If to Sponsor: Penterra Pharmaceuticals Corp. 200 Biopharma Boulevard, Suite 1400 Pri