MASTER CLINICAL TRIAL AGREEMENT
EXECUTION VERSION
June 28, 2023
by and between
PENTERRA PHARMACEUTICALS CORP. a Delaware corporation ("Sponsor" or "Penterra")
and
VERIDIAN HEALTH RESEARCH NETWORK, INC. a Delaware corporation ("Site Network" or "Veridian")
Protocol PPC-4871-III CLARION — Clinical Assessment of Response with Longitudinal Investigation in ONcology Investigational Product: Penterafenib (PPC-4871)
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PREAMBLE AND RECITALS
WHEREAS, Penterra Pharmaceuticals Corp. ("Penterra" or "Sponsor") is a publicly traded specialty pharmaceutical company listed on the Nasdaq Stock Market under the ticker symbol PTRA, with its principal executive offices located at 200 Biopharma Boulevard, Suite 1400, Princeton, New Jersey 08540, incorporated under the laws of the State of Delaware, with its registered agent being Capitol Registered Agents, LLC, located at 1209 Orange Street, Wilmington, Delaware 19801;
WHEREAS, Penterra is the sponsor of and holds the Investigational New Drug Application (IND No. 157823) for its investigational compound penterafenib (PPC-4871), an oral multi-kinase inhibitor targeting advanced hepatocellular carcinoma ("HCC"), for which the original IND was filed with the United States Food and Drug Administration ("FDA") in October 2021, and for which a Phase II clinical trial was completed in January 2023 demonstrating a thirty-eight percent (38%) objective response rate ("ORR") in subjects with advanced HCC, together with a manageable safety profile supporting advancement into Phase III development;
WHEREAS, Penterra intends to conduct a Phase III, randomized, double-blind, placebo-controlled clinical trial under Protocol PPC-4871-III, titled CLARION (Clinical Assessment of Response with Longitudinal Investigation in ONcology), which has been registered on ClinicalTrials.gov under Identifier NCT05928174, to evaluate the efficacy and safety of penterafenib in subjects with advanced HCC who have received prior systemic therapy;
WHEREAS, Veridian Health Research Network, Inc. ("Veridian" or "Site Network") is a Delaware 501(c)(3) tax-exempt research organization (Employer Identification Number: 23-4178205), with its principal offices located at 750 Research Parkway, 8th Floor, Philadelphia, Pennsylvania 19104, operating thirty-eight (38) academic medical centers and affiliated research institutions across fourteen (14) states in the United States, with an annual sponsored research volume of approximately One Billion Four Hundred Million Dollars ($1,400,000,000) and approximately six thousand two hundred (6,200) employees dedicated to the advancement of clinical research and patient care;
WHEREAS, Penterra desires to engage Veridian and its Network Sites (as defined herein) to participate in the conduct of the CLARION trial across Veridian's network of academic medical centers and affiliated research institutions, and Veridian desires to make its Network Sites and associated investigator expertise available for such participation, recognizing the potential public health significance of penterafenib in the treatment of advanced hepatocellular carcinoma;
WHEREAS, Penterra has separately engaged Meridian Contract Research Organization, Inc. ("Meridian CRO"), a Delaware corporation headquartered at 9200 Corporate Boulevard, Raleigh, North Carolina 27615, pursuant to a Master Services Agreement dated January 15, 2023 (the "CRO Agreement"), for monitoring, data management, safety reporting, and biostatistics services in connection with the CLARION trial, and the Parties acknowledge the role of Meridian CRO in the conduct and oversight of the Study;
WHEREAS, the Parties desire to set forth the comprehensive terms and conditions governing the conduct of the Study at the Network Sites, including without limitation site fees and budget, payment schedules and milestones, indemnification and subject-injury provisions, insurance requirements, data ownership and access, publication rights, regulatory compliance obligations, confidentiality and data protection, intellectual property, representations and warranties, term and termination, and dispute resolution; and
NOW, THEREFORE, in consideration of the mutual covenants, promises, and agreements contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:
ARTICLE I — DEFINITIONS
As used in this Agreement, the following terms shall have the meanings set forth below. Capitalized terms used but not defined in this Article I shall have the meanings assigned to them elsewhere in this Agreement or, if not so defined, shall have their ordinary and customary meaning in the context of clinical research and pharmaceutical development.
1.1 "Adverse Event" or "AE" means any untoward medical occurrence in a Subject administered the Investigational Product or placebo, whether or not considered related to the Investigational Product, including any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the Investigational Product or placebo. An Adverse Event does not necessarily have a causal relationship with the treatment.
1.2 "Affiliate" means, with respect to any Party, any entity that, directly or indirectly, controls, is controlled by, or is under common control with such Party. For purposes of this definition, "control" means the direct or indirect ownership of fifty percent (50%) or more of the outstanding voting securities of an entity, or the power to direct or cause the direction of the management and policies of such entity, whether through ownership of voting securities, by contract, or otherwise.
1.3 "Agreement" or "MCTA" means this Master Clinical Trial Agreement, including all Exhibits and Schedules attached hereto and incorporated herein by reference, as the same may be amended, modified, or supplemented from time to time in accordance with the terms hereof.
1.4 "Anti-Kickback Statute" means the federal Anti-Kickback Statute, codified at 42 U.S.C. § 1320a-7b, and the regulations promulgated thereunder, as amended from time to time, including the safe harbor regulations set forth at 42 C.F.R. § 1001.952.
1.5 "Applicable Law" means all applicable federal, state, and local laws, statutes, ordinances, rules, regulations, orders, guidances, and guidelines applicable to the conduct of the Study and the obligations of the Parties under this Agreement, including without limitation: (a) Title 21 of the Code of Federal Regulations, Parts 11 (Electronic Records; Electronic Signatures), 50 (Protection of Human Subjects), 54 (Financial Disclosure by Clinical Investigators), 56 (Institutional Review Boards), and 312 (Investigational New Drug Application); (b) the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guideline for Good Clinical Practice E6(R2) ("ICH E6(R2)"); (c) the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, and the implementing regulations at 45 C.F.R. Parts 160 and 164 (collectively, "HIPAA"); (d) the Anti-Kickback Statute, as defined in Section 1.4; (e) the Physician Payments Sunshine Act, codified at 42 U.S.C. § 1320a-7h, and the implementing regulations (collectively, the "Sunshine Act" or "Open Payments"); and (f) the Federal Food, Drug, and Cosmetic Act, as amended, 21 U.S.C. §§ 301 et seq.
1.6 "Briarcliff Policy" means the clinical trial liability insurance policy issued by Briarcliff Mutual Insurance Company, 55 Constitution Plaza, Hartford, Connecticut 06103, to Penterra Pharmaceuticals Corp., designated as Policy No. BM-CTL-2023-04182, as more fully described in Article X and Exhibit E of this Agreement.
1.7 "ClinicalTrials.gov Identifier" means the registration number NCT05928174 assigned to the CLARION trial on ClinicalTrials.gov, maintained by the National Library of Medicine of the United States National Institutes of Health.
1.8 "Closing Date" means the date on which all Conditions Precedent set forth in Section 1.9 have been satisfied or waived in writing by the applicable Party, which the Parties anticipate to be July 5, 2023.
1.9 "Conditions Precedent" means the following conditions that must be satisfied or waived before the Effective Date: (a) delivery by Sponsor to Veridian of certificates of insurance evidencing the coverage required under Article X; (b) receipt by Sponsor of written evidence of IRB approval for the Protocol at each of the Lead Sites; (c) execution and delivery of investigator signature pages by the Global Principal Investigator and the Co-Principal Investigator; and (d) such other conditions as may be mutually agreed by the Parties in writing.
1.10 "Confidential Information" means all information, whether in written, oral, electronic, visual, or other form, that is disclosed by one Party (the "Disclosing Party") to the other Party (the "Receiving Party") in connection with this Agreement, including without limitation all Protocol-related information, Investigational Product specifications, formulation and manufacturing data, Study Data, subject-level data, financial terms, budgets, payment schedules, business plans, strategic information, and any other proprietary or non-public information, regardless of whether marked as "confidential" or "proprietary." Confidential Information shall be subject to the exclusions set forth in Section 12.3.
1.11 "CRO" means Meridian Contract Research Organization, Inc., a Delaware corporation with its principal offices at 9200 Corporate Boulevard, Raleigh, North Carolina 27615, which has been engaged by Sponsor pursuant to the CRO Agreement for monitoring, data management, safety reporting, and biostatistics services in connection with the Study.
1.12 "EDC Vendor" means Pinnacle Data Solutions, Inc., a company with its principal offices at 6000 Clearwater Drive, San Diego, California 92121, which has been engaged by Sponsor to provide the electronic data capture platform for the Study.
1.13 "Effective Date" means July 18, 2023, or such later date as may result from the satisfaction of the Conditions Precedent.
1.14 "Enrollment Period" means the period of forty-two (42) months commencing on the date of First Patient In during which subjects may be enrolled in the Study.
1.15 "First Patient In" or "FPI" means the date on which the first Subject is enrolled and randomized in the Study at any Network Site. The target date for First Patient In is August 14, 2023.
1.16 "GCP" or "Good Clinical Practice" means the ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials that involve the participation of human subjects, as set forth in the ICH E6(R2) Guideline for Good Clinical Practice, and as reflected in applicable FDA regulations.
1.17 "Global Principal Investigator" means Dr. Catherine Aldridge, M.D., Ph.D., Professor of Oncology at Graystone University Medical Center, who has been designated by Sponsor, in consultation with Veridian, as the overall principal investigator for the CLARION trial.
1.18 "IND" means Investigational New Drug Application No. 157823, filed by Penterra with the FDA in October 2021 for penterafenib (PPC-4871) and maintained in good standing as of the Signing Date.
1.19 "Individual Site Agreement" means the joinder agreement to be executed by each Network Site in substantially the form attached hereto as Exhibit C, pursuant to which such Network Site agrees to participate in the Study and to be bound by the applicable terms and conditions of this MCTA.
1.20 "Institutional Review Board" or "IRB" means the institutional review board or independent ethics committee responsible for the review, approval, and continuing oversight of the Study at each Network Site, established and operating in accordance with 21 C.F.R. Part 56 and applicable federal, state, and institutional requirements.
1.21 "Investigational Product" means penterafenib (PPC-4871), an oral multi-kinase inhibitor, in the dosage forms and strengths specified in the Protocol and Investigator's Brochure, together with matching placebo, as supplied by Sponsor for use in the Study.
1.22 "Investigator" means each principal investigator and sub-investigator at a Network Site who is identified on the FDA Form 1572 and delegated responsibility for the conduct of the Study at such Network Site, and who has executed an Investigator Undertaking in the form of Exhibit I.
1.23 "Lead Sites" means (a) Graystone University Medical Center, designated as Site 001, and (b) Lakemont Medical Center, designated as Site 002, which are the first two Network Sites to be activated under this Agreement and at which the Global Principal Investigator and Co-Principal Investigator, respectively, are located.
1.24 "Central Laboratory" means Northbridge Bioanalytical Laboratories, Inc., with its principal offices at 2900 Commerce Way, Baltimore, Maryland 21224, which has been engaged by Sponsor to perform centralized pharmacokinetic/pharmacodynamic ("PK/PD"), biomarker, and safety laboratory analyses for the Study.
1.25 "Network Sites" means the thirty-eight (38) academic medical centers and affiliated research institutions operated by or affiliated with Veridian that are identified on Schedule 1 attached hereto and that execute Individual Site Agreements to participate in the Study.
1.26 "Open Payments" means the reporting obligations arising under the Physician Payments Sunshine Act, 42 U.S.C. § 1320a-7h, and the implementing regulations promulgated by the Centers for Medicare & Medicaid Services, requiring manufacturers of covered drugs, devices, biologicals, and medical supplies to report certain payments and transfers of value made to physicians and teaching hospitals.
1.27 "Party" means Penterra or Veridian, individually, and "Parties" means Penterra and Veridian, collectively.
1.28 "Per-Patient Fee" means the amount of Fifty-Two Thousand Dollars ($52,000) payable per Subject enrolled in the Study, as set forth in Article V and Exhibit B.
1.29 "Protocol" means Protocol PPC-4871-III, titled CLARION (Clinical Assessment of Response with Longitudinal Investigation in ONcology), as approved by the FDA and as may be amended from time to time in accordance with this Agreement and Applicable Law.
1.30 "SAE" or "Serious Adverse Event" means any Adverse Event occurring at any dose that results in any of the following outcomes: death, a life-threatening adverse experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that, based on appropriate medical judgment, may jeopardize the Subject and may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.
1.31 "Signing Date" means June 28, 2023, the date on which the Parties have executed this Agreement.
1.32 "Source Documents" means all original documents, data, and records at the Network Sites, including but not limited to hospital records, clinical and office charts, laboratory and pharmacy records, diaries, microfiches, X-rays, subject files, and records kept at the pharmacy, laboratories, and medico-technical departments involved in the Study.
1.33 "Sponsor" means Penterra Pharmaceuticals Corp., a Delaware corporation, in its capacity as the sponsor of the Study and the holder of the IND.
1.34 "Study" or "CLARION Trial" means the Phase III, randomized, double-blind, placebo-controlled clinical trial of penterafenib (PPC-4871) conducted under the Protocol, as described in Article II and the Protocol Synopsis attached as Exhibit A.
1.35 "Study Completion" means the date on which all Study-related activities have been concluded at all Network Sites, including without limitation the completion of the final Subject visit, resolution of all outstanding data queries, completion of database lock, and close-out of all Network Sites. The projected date of Study Completion is August 2028.
1.36 "Study Data" means all data, results, analyses, reports, information, and records generated in connection with the conduct of the Study at the Network Sites, including without limitation data entered in the electronic data capture system, central laboratory results, imaging data, biomarker data, pharmacokinetic and pharmacodynamic data, safety data, efficacy data, and subject-reported outcome data, regardless of form or medium.
1.37 "Subject" means an individual who has provided informed consent and has been enrolled and randomized in the Study in accordance with the Protocol and Applicable Law.
1.38 "Total Study Duration" means sixty (60) months, consisting of a forty-two (42) month Enrollment Period and an eighteen (18) month follow-up period, subject to adjustment as may be necessary based on enrollment rates, protocol amendments, or other factors.
ARTICLE II — SCOPE OF AGREEMENT
2.1 Purpose. This Agreement establishes the terms and conditions under which Veridian and its Network Sites will participate in and conduct the CLARION trial, a Phase III, randomized, double-blind, placebo-controlled study of penterafenib (PPC-4871) in subjects with advanced hepatocellular carcinoma who have received at least one prior line of systemic therapy. The Study is designed to evaluate the efficacy and safety of penterafenib as compared to placebo, with the goal of supporting a New Drug Application ("NDA") submission to the FDA. This Agreement is intended to serve as the master agreement governing the relationship between Sponsor and Veridian with respect to the Study, with each participating Network Site executing an Individual Site Agreement that incorporates the terms of this MCTA by reference.
2.2 Study Design. The CLARION trial is designed as a Phase III, randomized, double-blind, placebo-controlled, multi-center study. The planned enrollment is twelve hundred (1,200) Subjects, randomized in a 2:1 ratio, with eight hundred (800) Subjects assigned to the penterafenib arm and four hundred (400) Subjects assigned to the placebo arm. All Subjects in both arms will receive best supportive care in accordance with institutional standards and the Protocol. The primary endpoint of the Study is overall survival ("OS"), defined as the time from randomization to death from any cause. Key secondary endpoints include progression-free survival ("PFS"), as assessed by blinded independent central review using RECIST v1.1 criteria; objective response rate ("ORR"), defined as the proportion of Subjects achieving a confirmed complete response or partial response; and duration of response ("DOR"), defined as the time from first documented objective response to disease progression or death. Additional secondary and exploratory endpoints are set forth in the Protocol Synopsis attached as Exhibit A.
2.3 Protocol. The Study shall be conducted in strict accordance with Protocol PPC-4871-III, as summarized in the Protocol Synopsis attached hereto as Exhibit A and as may be amended from time to time. The Protocol has been reviewed and approved by the FDA under IND 157823. The Protocol may be amended only by Sponsor in writing, and any such amendment shall be submitted to the FDA in accordance with 21 C.F.R. § 312.30 and to the IRB at each Network Site in accordance with 21 C.F.R. Part 56. No Network Site or Investigator shall implement a Protocol amendment until the applicable IRB has reviewed and approved such amendment, except where an immediate change is necessary to eliminate an apparent immediate hazard to Subjects, in which case the Investigator may implement the change and promptly notify the IRB and Sponsor.
2.4 Network Sites. The Study shall be conducted at thirty-eight (38) Veridian Network Sites across fourteen (14) states, as identified on Schedule 1 attached hereto. The Network Sites have been selected based on their demonstrated capabilities in oncology clinical research, their access to appropriate patient populations with advanced hepatocellular carcinoma, and their prior track record in conducting multi-center clinical trials within the Veridian network. Veridian shall be responsible for coordinating among the Network Sites and for serving as the primary point of contact between the Network Sites and Sponsor with respect to network-level administrative, regulatory, and operational matters.
2.5 Individual Site Agreements. Each Network Site participating in the Study shall execute an Individual Site Agreement in substantially the form attached hereto as Exhibit C. Each Individual Site Agreement shall incorporate the terms and conditions of this MCTA by reference and shall contain site-specific information, including the identity of the principal investigator, the site-specific enrollment target, and such other site-specific terms as may be necessary or appropriate. No Network Site shall commence Study activities, including screening of potential Subjects, until the applicable Individual Site Agreement has been fully executed and all site-specific Conditions Precedent have been satisfied.
2.6 Total Value. The total estimated value of this Agreement is Eighty Million Dollars ($80,000,000), as detailed in Article V and the Budget and Payment Schedule attached hereto as Exhibit B. The Parties acknowledge that the actual total payments under this Agreement may vary from this estimate based on actual enrollment numbers, the duration of the Study, and other factors, and that the estimated total value is provided for planning and disclosure purposes. All payments made under this Agreement shall reflect fair market value for the services provided, as more fully set forth in Section 5.9.
2.7 Duration. This Agreement shall commence on the Effective Date and shall continue in full force and effect until the earlier of (a) Study Completion, which is projected to occur in August 2028, or (b) termination of this Agreement in accordance with Article XIV. Notwithstanding the foregoing, the provisions identified in Section 14.6 shall survive expiration or termination of this Agreement in accordance with their terms.
ARTICLE III — RESPONSIBILITIES OF SPONSOR
3.1 IND Maintenance. Penterra, as the IND holder (IND No. 157823), shall maintain the IND in good standing with the FDA throughout the duration of the Study. Sponsor shall be responsible for all communications with the FDA regarding the IND, including without limitation the submission of annual reports (21 C.F.R. § 312.33), protocol amendments (21 C.F.R. § 312.30), IND safety reports (21 C.F.R. § 312.32), and information amendments (21 C.F.R. § 312.31). Sponsor shall promptly notify Veridian of any FDA clinical hold, partial clinical hold, or other regulatory action affecting the IND or the conduct of the Study.
3.2 Investigational Product Supply. Sponsor shall supply penterafenib (PPC-4871) in the dosage forms and strengths specified in the Protocol, together with matching placebo, to each Network Site at no cost to the Network Site, in quantities sufficient for all enrolled Subjects throughout the duration of the Study. The Investigational Product shall be manufactured, packaged, labeled, and shipped in accordance with current Good Manufacturing Practices ("cGMP") as set forth in 21 C.F.R. Parts 210 and 211. Sponsor shall provide shipping and storage instructions, and Network Sites shall store the Investigational Product in accordance with the conditions specified on the product label and in the Investigator's Brochure. Sponsor shall be responsible for drug accountability and reconciliation procedures, which shall be further detailed in the pharmacy manual provided to each Network Site.
3.3 Protocol and Case Report Forms. Sponsor shall provide to Veridian and each Network Site the Protocol, the Investigator's Brochure, the informed consent template, case report form templates (in electronic format for the Pinnacle EDC platform), and such other Study documents and materials as may be necessary for the proper conduct of the Study. Sponsor shall provide updated versions of such documents as needed throughout the duration of the Study, including any Protocol amendments, revised Investigator's Brochures, and revised informed consent templates.
3.4 Monitoring. Sponsor shall arrange for monitoring of the Network Sites through Meridian CRO in accordance with ICH E6(R2) GCP requirements, 21 C.F.R. Part 312, and the monitoring plan developed by Sponsor. Monitoring activities shall include, without limitation, on-site monitoring visits at regular intervals, remote source data verification, review of informed consent forms and IRB documentation, drug accountability, and review of regulatory files. The frequency and scope of monitoring visits shall be determined by Sponsor and Meridian CRO based on enrollment rates, data quality metrics, and risk-based monitoring principles, as further set forth in the monitoring plan. Sponsor shall provide Veridian with periodic monitoring reports at the network level upon reasonable request.
3.5 Safety Reporting. Sponsor shall be responsible for the submission of IND safety reports to the FDA in accordance with 21 C.F.R. § 312.32, including: (a) telephone or facsimile reports within seven (7) calendar days of initial receipt of information regarding any adverse reaction that is both serious and unexpected, and that is fatal or life-threatening; and (b) written reports within fifteen (15) calendar days of initial receipt of information regarding any adverse reaction that is both serious and unexpected and is not subject to seven-day reporting. Sponsor shall promptly distribute safety information, including IND safety reports, Suspected Unexpected Serious Adverse Reaction ("SUSAR") reports, and aggregate safety data, to all Network Sites and Investigators for submission to their respective IRBs. Sponsor shall maintain a global safety database for the Study and shall be responsible for the ongoing evaluation of the benefit-risk profile of the Investigational Product.
3.6 Insurance. Sponsor shall obtain and maintain clinical trial liability insurance throughout the duration of the Study and for a period of not less than three (3) years following Study Completion, with the minimum coverage levels and terms set forth in Article X of this Agreement.
3.7 Regulatory Filings. Sponsor shall be responsible for all regulatory filings and submissions to the FDA and other applicable regulatory authorities in connection with the IND and the conduct of the Study, including without limitation the filing of Protocol amendments, annual reports, safety reports, and any future NDA submission. Veridian and the Network Sites shall cooperate with Sponsor as reasonably necessary in connection with such regulatory filings, including the provision of data, information, and documentation as may be required.
3.8 Third-Party Vendors. Sponsor has engaged the following approved subcontractors for the provision of services in connection with the Study, as further described on Exhibit K:
(a) Meridian Contract Research Organization, Inc. — monitoring, data management, safety reporting, and biostatistics services;
(b) Pinnacle Data Solutions, Inc. — electronic data capture ("EDC") platform for the collection, management, and storage of Study Data in compliance with 21 C.F.R. Part 11;
(c) Northbridge Bioanalytical Laboratories, Inc. — central laboratory services for pharmacokinetic/pharmacodynamic analyses, biomarker assays, and safety laboratory analyses.
Sponsor shall be responsible for the performance of its approved subcontractors and shall ensure that each subcontractor is bound by confidentiality and data protection obligations consistent with the terms of this Agreement. Veridian and the Network Sites shall cooperate with Sponsor's approved subcontractors as reasonably necessary for the conduct of the Study.
3.9 Regulatory Counsel. Sponsor has separately retained Castleton & Hargrove LLP as its outside FDA regulatory counsel in connection with the CLARION trial and the overall regulatory strategy for penterafenib. The engagement of outside regulatory counsel does not relieve Sponsor of any of its obligations under this Agreement or Applicable Law.
ARTICLE IV — RESPONSIBILITIES OF SITE NETWORK AND INVESTIGATORS
4.1 Conduct of Study. Veridian shall ensure that each Network Site conducts the Study in accordance with the Protocol, GCP, Applicable Law, and the terms and conditions of this Agreement and the applicable Individual Site Agreement. Veridian shall exercise oversight of the Network Sites and shall take appropriate action, including corrective and preventive measures, to address any deficiencies identified during monitoring visits, audits, or regulatory inspections. Veridian acknowledges that Sponsor retains ultimate responsibility as the IND holder for the overall conduct of the Study, and Veridian shall cooperate with Sponsor in fulfilling that responsibility.
4.2 Principal Investigators. Veridian shall ensure the appointment of a qualified principal investigator at each Network Site who meets the qualifications set forth in 21 C.F.R. § 312.53 and who has been approved by Sponsor. The Global Principal Investigator for the CLARION trial is Dr. Catherine Aldridge, M.D., Ph.D., Professor of Oncology at Graystone University Medical Center (Site 001). The Co-Principal Investigator for the CLARION trial is Dr. Howard Matsuoka, M.D., at Lakemont Medical Center (Site 002). In the event that any principal investigator is unable to continue serving in such capacity for any reason, including departure from the institution, illness, disability, death, or disqualification, Veridian shall promptly notify Sponsor and propose a qualified replacement principal investigator for Sponsor's approval. No replacement principal investigator shall commence Study activities until approved by Sponsor, the applicable IRB, and the FDA (to the extent required by Applicable Law).
4.3 Investigator Undertaking. Each Investigator, including each principal investigator and each sub-investigator, shall execute an Investigator Undertaking in substantially the form attached hereto as Exhibit I, acknowledging and agreeing to comply with the Protocol, GCP, Applicable Law, and the terms and conditions of this Agreement as they relate to Investigators.
4.4 FDA Form 1572. Each principal investigator at each Network Site shall complete and submit to Sponsor a fully executed FDA Form 1572 (Statement of Investigator) prior to the commencement of any Study activities at such Network Site. The FDA Form 1572 shall be maintained current throughout the duration of the Study, and the principal investigator shall promptly submit an updated FDA Form 1572 to Sponsor in the event of any change in the information previously provided, including changes in sub-investigators, facilities, or IRB.
4.5 Financial Disclosures. Each Investigator, including each principal investigator and sub-investigator, and each person who directly controls or is directly controlled by the Investigator, shall complete and submit to Sponsor a Financial Disclosure Certification in accordance with 21 C.F.R. Part 54, using the template form included in the Study document set. Financial Disclosure Certifications shall be obtained prior to each Investigator's participation in the Study and shall be updated during the Study and for one (1) year after Study Completion, as required by 21 C.F.R. § 54.4. Veridian shall cooperate with Sponsor in collecting and maintaining Financial Disclosure Certifications from all Investigators within its network.
4.6 IRB Approval. Each Network Site shall obtain IRB approval of the Protocol, the informed consent form, and all other Study-related materials requiring IRB review prior to the enrollment of any Subject at such Network Site. The Lead Site, Graystone University Medical Center (Site 001), shall obtain IRB approval from the Graystone University Institutional Review Board (IRB Registration: IRB00012847, OHRP Federal-wide Assurance on file). Lakemont Medical Center (Site 002) and other non-Pennsylvania Network Sites may rely on the Veridian Central IRB pursuant to an IRB Authorization Agreement, consistent with the requirements of the 2018 revised Common Rule (45 C.F.R. Part 46, as revised effective January 21, 2019). Each Network Site shall be responsible for maintaining continuing IRB approval throughout the duration of the Study, including submission of continuing review applications, reportable events, Protocol amendments, and revised informed consent forms, in accordance with 21 C.F.R. Part 56 and institutional requirements. No Network Site shall enroll any Subject until valid IRB approval has been obtained and documented.
4.7 Enrollment. Veridian shall use commercially reasonable efforts to achieve the enrollment targets established by Sponsor for each Network Site, as set forth on Schedule 1. Veridian and each Network Site shall implement recruitment strategies and screening procedures designed to identify and enroll eligible Subjects in a timely manner. Sponsor and Veridian shall meet on a quarterly basis (or more frequently as reasonably requested by Sponsor) to review enrollment progress against targets and to develop and implement corrective action plans for sites that are significantly below target enrollment. Veridian acknowledges that the timely achievement of enrollment targets is material to the success of the Study and to Sponsor's regulatory and business timelines.
4.8 SAE Reporting. Each Network Site shall report all Serious Adverse Events to Sponsor and Meridian CRO within twenty-four (24) hours of the Investigator's awareness of such event, in accordance with the procedures set forth in Exhibit J attached hereto. SAE reports shall be submitted via the designated safety reporting portal or, if the portal is unavailable, by facsimile or email to the safety reporting contacts designated by Sponsor and Meridian CRO. Initial SAE reports shall be followed by supplemental reports as additional information becomes available, until the SAE is resolved, stabilized, or otherwise concluded. Each Network Site shall also report SAEs to its IRB in accordance with IRB requirements and Applicable Law. Failure to comply with SAE reporting timelines shall constitute a material breach of this Agreement and may result in the suspension or termination of the applicable Individual Site Agreement.
4.9 Source Document Retention. Each Network Site shall retain all Source Documents, including original medical records, informed consent forms, IRB correspondence, regulatory files, drug accountability records, and laboratory reports, for a minimum of fifteen (15) years following Study Completion or for such longer period as may be required by Applicable Law, institutional policy, or Sponsor's written instructions. No Source Documents shall be destroyed without the prior written consent of Sponsor. In the event that a Network Site or its institution is unable to continue serving as the custodian of Source Documents, Veridian shall notify Sponsor promptly and shall make arrangements for the transfer of Source Documents to an alternative custodian approved by Sponsor.
4.10 Regulatory Compliance. Veridian and each Network Site shall comply with all Applicable Law in connection with the conduct of the Study, including without limitation 21 C.F.R. Parts 11 (Electronic Records; Electronic Signatures), 50 (Protection of Human Subjects), 54 (Financial Disclosure by Clinical Investigators), 56 (Institutional Review Boards), and 312 (Investigational New Drug Application); ICH E6(R2) Good Clinical Practice; HIPAA (45 C.F.R. Parts 160 and 164); the Anti-Kickback Statute (42 U.S.C. § 1320a-7b); and the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h). Veridian shall promptly notify Sponsor of any regulatory action, investigation, or inquiry by any governmental authority relating to the conduct of the Study at any Network Site.
4.11 Network Coordination. Veridian's central office shall provide network-wide coordination services in support of the conduct of the Study, including without limitation centralized IRB administration (where applicable), site activation support and feasibility assessments, enrollment tracking and reporting, regulatory documentation management, distribution of Study materials and communications from Sponsor, coordination of Investigator meetings and training, and facilitation of communication among Network Sites, Sponsor, and Meridian CRO. Veridian's central office shall designate a Network Study Director as the primary point of contact for Sponsor with respect to network-level Study matters.
4.12 Insurance. Veridian and each Network Site shall obtain and maintain general liability and professional liability insurance throughout the duration of the Study and for a period of not less than three (3) years following Study Completion, with the minimum coverage levels set forth in Article X of this Agreement. Evidence of such insurance coverage shall be provided to Sponsor as set forth in Section 10.4.
ARTICLE V — BUDGET AND COMPENSATION
5.1 Total Budget. The total budget for this Agreement is Eighty Million Dollars ($80,000,000), as set forth in the Budget and Payment Schedule attached hereto as Exhibit B. The total budget is comprised of the following components:
(a) Per-Patient Site Fees: Fifty-Two Thousand Dollars ($52,000) per Subject multiplied by one thousand two hundred (1,200) Subjects, for a total of Sixty-Two Million Four Hundred Thousand Dollars ($62,400,000);
(b) Start-Up Fees: Seventy-Five Thousand Dollars ($75,000) per Network Site multiplied by thirty-eight (38) Network Sites, for a total of Two Million Eight Hundred Fifty Thousand Dollars ($2,850,000);
(c) Annual Site Maintenance Fees: Forty Thousand Dollars ($40,000) per Network Site per year multiplied by thirty-eight (38) Network Sites multiplied by an average of three and one-half (3.5) years, for a total of Five Million Three Hundred Twenty Thousand Dollars ($5,320,000);
(d) Investigator Grants: One Million Five Hundred Thousand Dollars ($1,500,000) as a lump sum allocation for the support of academic publications arising from the Study;
(e) Network Coordination/Administrative Fee: Four Million Two Hundred Thousand Dollars ($4,200,000), payable in fourteen (14) quarterly installments of Three Hundred Thousand Dollars ($300,000) each to Veridian's central office;
(f) Technology/EDC Integration Costs: One Million Two Hundred Thirty Thousand Dollars ($1,230,000), representing a fixed cost for the integration of the Pinnacle Data Solutions EDC platform with Veridian's existing clinical research information systems; and
(g) Contingency/Change Order Reserve: Two Million Five Hundred Thousand Dollars ($2,500,000), to cover unanticipated costs, Protocol amendments, additional monitoring visits, and other change orders approved by Sponsor in writing.
The Parties acknowledge that the total budget is an estimate based on planned enrollment of one thousand two hundred (1,200) Subjects and the anticipated duration of the Study, and that actual payments may vary based on actual enrollment, the actual duration of the Study, and the utilization of the contingency reserve. In no event shall Sponsor be obligated to pay amounts in excess of the total budget without the prior written agreement of the Parties in the form of a written amendment or change order.
5.2 Per-Patient Fee Milestones. The Per-Patient Fee of Fifty-Two Thousand Dollars ($52,000) per Subject shall be paid on a milestone basis in four (4) equal installments of Thirteen Thousand Dollars ($13,000) each, upon the occurrence of the following milestones:
(i) Thirteen Thousand Dollars ($13,000), representing twenty-five percent (25%) of the Per-Patient Fee, payable upon randomization of the Subject in the Study;
(ii) Thirteen Thousand Dollars ($13,000), representing twenty-five percent (25%) of the Per-Patient Fee, payable upon completion of the Week 12 efficacy assessment for the Subject;
(iii) Thirteen Thousand Dollars ($13,000), representing twenty-five percent (25%) of the Per-Patient Fee, payable upon completion of the Week 24 efficacy assessment for the Subject; and
(iv) Thirteen Thousand Dollars ($13,000), representing twenty-five percent (25%) of the Per-Patient Fee, payable upon completion of the Subject's final study visit, including the end-of-treatment visit and the safety follow-up visit, or upon the Subject's early discontinuation from the Study and completion of all required end-of-study procedures.
Per-Patient Fees shall be invoiced by Veridian on behalf of the applicable Network Site upon achievement of each milestone and payment of such milestones by Sponsor shall be subject to confirmation by Meridian CRO that the applicable milestone has been achieved and that the subject data supporting such milestone have been entered into the Pinnacle EDC platform and are complete and evaluable.
5.3 Start-Up Fee Payment. Start-up fees of Seventy-Five Thousand Dollars ($75,000) per Network Site shall be paid in two (2) installments, as follows:
(i) Thirty-Seven Thousand Five Hundred Dollars ($37,500), payable upon activation of the Network Site, which shall be deemed to occur upon the date on which all of the following conditions have been satisfied: execution of the Individual Site Agreement, receipt of IRB approval, completion of site initiation visit, and receipt of Investigational Product at the site; and
(ii) Thirty-Seven Thousand Five Hundred Dollars ($37,500), payable upon the enrollment (randomization) of the first Subject at such Network Site.
5.4 Network Coordination Fee. Veridian's central office shall receive quarterly installments of Three Hundred Thousand Dollars ($300,000) for the provision of network coordination services described in Section 4.11, payable over fourteen (14) quarters commencing on the Effective Date, for a total Network Coordination Fee of Four Million Two Hundred Thousand Dollars ($4,200,000). Quarterly Network Coordination Fee installments shall be invoiced by Veridian within ten (10) business days following the end of each calendar quarter and shall be payable in accordance with Section 5.7.
5.5 Site Maintenance Fees. Annual site maintenance fees of Forty Thousand Dollars ($40,000) per Network Site shall be paid annually in advance on or before each anniversary of the applicable site's activation date, for the duration of the Study or until the applicable Individual Site Agreement is terminated, whichever occurs first. Site maintenance fees are intended to cover the ongoing administrative, regulatory, and infrastructure costs associated with maintaining a Network Site's participation in the Study, including IRB continuing review, regulatory file maintenance, personnel training, and Study supplies.
5.6 Investigator Grants. The Investigator Grants allocation of One Million Five Hundred Thousand Dollars ($1,500,000) shall be available for disbursement to support academic publications arising from the Study. Disbursements from this allocation shall be made upon the acceptance of manuscripts for publication in peer-reviewed journals, subject to the following: (a) the manuscript must relate to the CLARION trial; (b) the manuscript must have been submitted to and reviewed by Sponsor in accordance with Article IX; and (c) the Investigator must submit a written request for grant funding, accompanied by the journal's acceptance letter, to Sponsor for approval. The specific amount of each grant disbursement shall be determined on a case-by-case basis, based on the scope and significance of the publication, subject to a maximum of One Hundred Thousand Dollars ($100,000) per individual publication.
5.7 Payment Terms. All payments due under this Agreement shall be payable Net Forty-Five (45) days from Sponsor's receipt of a proper and complete invoice from Veridian. Invoices shall be submitted in electronic format to the attention of the Sponsor's Clinical Finance Department at the address specified in Article XIX, or to such other address or electronic submission portal as Sponsor may designate in writing. Each invoice shall include sufficient detail to enable Sponsor to verify the amounts invoiced, including the applicable site identification number, the milestone or fee category, the amount invoiced, and supporting documentation as reasonably requested by Sponsor. Sponsor shall notify Veridian in writing within fifteen (15) business days of receipt of an invoice of any disputed amounts, and the Parties shall work in good faith to resolve any such disputes promptly. Undisputed amounts shall be paid in accordance with this Section 5.7 notwithstanding any dispute regarding other amounts.
5.8 Taxes. Each Party shall be responsible for its own tax obligations arising from or in connection with this Agreement, including without limitation all federal, state, and local income taxes, employment taxes, and other applicable taxes. Veridian shall, upon request, provide to Sponsor documentation of its status as a tax-exempt organization under Section 501(c)(3) of the Internal Revenue Code of 1986, as amended, and shall promptly notify Sponsor of any change in its tax-exempt status. No withholding shall be applied to payments made under this Agreement unless required by Applicable Law.
5.9 Fair Market Value. The Parties represent and warrant that all compensation payable under this Agreement, including the Per-Patient Fee, start-up fees, site maintenance fees, Investigator Grants, Network Coordination Fees, and all other amounts, reflects fair market value for the services, facilities, and resources to be provided in connection with the Study, determined without regard to the volume or value of any referrals between the Parties or their Affiliates, in compliance with the Anti-Kickback Statute, 42 U.S.C. § 1320a-7b, and the applicable safe harbor regulations at 42 C.F.R. § 1001.952. The Parties acknowledge that the compensation structure under this Agreement has been designed to comply with the personal services and management contracts safe harbor set forth at 42 C.F.R. § 1001.952(d). Each Party has engaged independent advisors, including fair market value consultants, to assess the reasonableness of the compensation set forth herein.
5.10 Open Payments Reporting. Sponsor shall comply with all reporting obligations under the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h) and the implementing regulations with respect to payments and transfers of value made to physicians and teaching hospitals in connection with the Study. Veridian and each Investigator shall cooperate with Sponsor's reporting obligations under the Sunshine Act, including the timely provision of information necessary for Sponsor to identify covered recipients and to accurately report payments and transfers of value. Veridian shall ensure that each Network Site and Investigator is aware of Sponsor's Open Payments reporting obligations and shall facilitate communication between Sponsor and Investigators as needed.
ARTICLE VI — REGULATORY COMPLIANCE
6.1 Applicable Regulations. The Study shall be conducted in compliance with all Applicable Law, including without limitation the following: (a) 21 C.F.R. Part 11 (Electronic Records; Electronic Signatures), governing the creation, modification, maintenance, archival, retrieval, and transmission of electronic records and the use of electronic signatures; (b) 21 C.F.R. Part 50 (Protection of Human Subjects), governing informed consent, additional safeguards for children in clinical investigations, and the Institutional Review Board review of clinical investigations; (c) 21 C.F.R. Part 54 (Financial Disclosure by Clinical Investigators), governing the disclosure of financial interests and arrangements of clinical investigators; (d) 21 C.F.R. Part 56 (Institutional Review Boards), governing the composition, functions, and operations of Institutional Review Boards; (e) 21 C.F.R. Part 312 (Investigational New Drug Application), governing the submission, review, and management of INDs and the conduct of clinical investigations; (f) ICH E6(R2), the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guideline for Good Clinical Practice; and (g) HIPAA (45 C.F.R. Parts 160 and 164), governing the privacy and security of individually identifiable health information.
6.2 Anti-Kickback Statute. The Parties represent and warrant that this Agreement has been structured to comply with the Anti-Kickback Statute (42 U.S.C. § 1320a-7b) and the applicable safe harbor regulations, including the personal services and management contracts safe harbor (42 C.F.R. § 1001.952(d)). Each Party acknowledges that no payment or other remuneration under this Agreement is intended to induce or reward the referral of patients, the purchasing, leasing, ordering, or arranging for or recommending the purchasing, leasing, or ordering of any item or service for which payment may be made in whole or in part under a federal health care program. The Parties have structured the compensation under this Agreement to reflect fair market value, as set forth in Section 5.9, and have set the compensation in advance, as contemplated by the safe harbor regulations. Each Party shall promptly notify the other Party of any governmental investigation, inquiry, or proceeding relating to potential violations of the Anti-Kickback Statute in connection with this Agreement.
6.3 Sunshine Act. Sponsor shall comply with all reporting obligations under the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h) and the implementing regulations promulgated by the Centers for Medicare & Medicaid Services. Sponsor shall track and report all payments and transfers of value made to physicians and teaching hospitals in connection with the Study, including but not limited to research payments, consulting fees, travel and lodging, and educational items. Veridian and each Investigator shall cooperate with Sponsor in the tracking and reporting of such payments, including the provision of National Provider Identifier ("NPI") numbers, medical license information, and such other information as may be required by Sponsor for compliance with Open Payments reporting obligations.
6.4 HIPAA. Each Network Site shall comply with HIPAA and the implementing regulations at 45 C.F.R. Parts 160 and 164 in connection with the use and disclosure of protected health information ("PHI") in the conduct of the Study. Each Network Site shall ensure that valid HIPAA research authorizations are obtained from each Subject prior to the use or disclosure of the Subject's PHI for Study purposes, or that an IRB waiver of authorization has been obtained in accordance with 45 C.F.R. § 164.512(i)(1)(i). All disclosures of PHI among Sponsor, the Network Sites, and Meridian CRO shall comply with the minimum necessary standard set forth in 45 C.F.R. § 164.502(b) and shall be limited to the minimum amount of information necessary to accomplish the purpose of the disclosure. Sponsor and Meridian CRO shall enter into business associate agreements with Network Sites as required by HIPAA.
6.5 FDA Inspections. Each Network Site shall cooperate fully with any inspections or audits conducted by the FDA, other regulatory authorities, Sponsor, or Meridian CRO in connection with the Study. Veridian and each Network Site shall provide the FDA and other regulatory authorities with direct access to Source Documents, facilities, and Study personnel as required by Applicable Law. Each Network Site shall promptly notify Sponsor and Veridian's central office of any FDA inspection or regulatory inquiry relating to the Study and shall provide Sponsor with copies of any FDA Form 483 observations, Establishment Inspection Reports, Warning Letters, or other regulatory correspondence relating to the Study within five (5) business days of receipt.
6.6 Debarment. Veridian represents and warrants that, as of the Signing Date and throughout the duration of this Agreement, neither Veridian nor any of its officers, directors, employees, Investigators, or agents participating in the Study has been debarred under 21 U.S.C. § 335a(a) or (b), disqualified or restricted under 21 C.F.R. § 312.70, excluded from participation in federal health care programs under 42 U.S.C. § 1320a-7, or convicted of a criminal offense that would support debarment, disqualification, or exclusion. Veridian shall promptly notify Sponsor in writing if, at any time during the term of this Agreement, any person participating in the Study on behalf of Veridian or any Network Site becomes debarred, disqualified, excluded, or convicted as described in this Section 6.6. Upon receipt of such notification, Sponsor shall have the right to immediately remove such person from participation in the Study and, if warranted, to terminate the applicable Individual Site Agreement.
6.7 Detailed Provisions. Additional regulatory compliance representations, covenants, and warranties are set forth in Exhibit H attached hereto and incorporated herein by reference.
ARTICLE VII — STUDY DATA AND RECORDS
7.1 Data Ownership. Penterra shall retain exclusive ownership of all Study Data, including without limitation all data captured through the Pinnacle Data Solutions EDC platform, all central laboratory results generated by Northbridge Bioanalytical Laboratories, Inc., all CRO-processed data generated by Meridian CRO, and all analyses, reports, compilations, and derivative works generated from or based on the Study Data. Veridian acknowledges and agrees that all Study Data are the proprietary property of Sponsor and constitute Confidential Information of Sponsor. Notwithstanding the foregoing, Veridian and the Network Sites shall retain ownership of their respective Source Documents, subject to Sponsor's right of access as set forth in Section 7.3 and the Investigators' right to publish as set forth in Article IX.
7.2 Source Document Retention. Each Network Site shall retain all Source Documents for a minimum period of fifteen (15) years following Study Completion or for such longer period as may be required by Applicable Law, institutional policy, or Sponsor's written instructions, whichever is longer. Source Documents shall be stored in a secure and accessible location and shall be maintained in a manner that ensures their integrity, legibility, and retrievability throughout the retention period. Veridian shall notify Sponsor at least six (6) months prior to the anticipated destruction of any Source Documents and shall not destroy any Source Documents without the prior written consent of Sponsor.
7.3 Access to Data. Sponsor, its designees (including Meridian CRO), and regulatory authorities (including the FDA) shall have access to all Study Data, Source Documents, and regulatory files maintained at each Network Site at all reasonable times during the conduct of the Study and for the duration of the Source Document retention period set forth in Section 7.2. Such access shall include, without limitation, the right to inspect, copy, and audit Study records for the purpose of monitoring data quality, verifying Study conduct, and satisfying regulatory requirements. Veridian and each Network Site shall cooperate fully with such access and shall ensure that Study records are maintained in a manner that facilitates efficient review.
7.4 Electronic Data Capture. All Study Data shall be captured through the Pinnacle Data Solutions, Inc. EDC platform in compliance with 21 C.F.R. Part 11. Each Network Site shall ensure that authorized Study personnel complete training on the use of the Pinnacle EDC platform prior to data entry and shall comply with all data entry timelines, query resolution procedures, and quality control requirements specified by Sponsor and Pinnacle Data Solutions. The EDC platform shall include a complete audit trail of all data entries, modifications, and deletions, and shall employ validated electronic signature functionality for the authentication of data entries by Investigators and other authorized personnel.
7.5 Central Laboratory. All pharmacokinetic/pharmacodynamic, biomarker, and safety laboratory analyses specified in the Protocol shall be performed by Northbridge Bioanalytical Laboratories, Inc., the designated Central Laboratory for the Study. Network Sites shall collect and ship biological specimens to the Central Laboratory in accordance with the specimen collection, processing, and shipping manual provided by Sponsor. All Central Laboratory results shall be transmitted electronically to the Pinnacle EDC platform and shall become part of the Study Data. Network Sites may perform local laboratory analyses only to the extent specified in the Protocol for the purpose of immediate clinical decision-making (e.g., eligibility confirmation, safety assessments), and such local laboratory results shall also be entered into the EDC platform.
ARTICLE VIII — INTELLECTUAL PROPERTY
8.1 Pre-Existing IP. Each Party shall retain all right, title, and interest in and to its respective pre-existing intellectual property, including without limitation patents, patent applications, trade secrets, know-how, copyrights, trademarks, and other intellectual property rights owned or controlled by such Party as of the Signing Date or developed independently of the Study. Nothing in this Agreement shall be construed as granting either Party any license or other rights in or to the other Party's pre-existing intellectual property, except as expressly provided herein or in the IP Side Letter.
8.2 Study Inventions. Ownership of inventions, discoveries, improvements, and other intellectual property arising from the conduct of the Study ("Study Inventions") shall be determined as follows:
(a) Study Inventions conceived or first reduced to practice solely by employees, agents, or contractors of Sponsor shall be the sole and exclusive property of Sponsor;
(b) Study Inventions conceived or first reduced to practice solely by employees, agents, or investigators of Veridian or a Network Site shall be the sole and exclusive property of Veridian or the applicable Network Site, as determined in accordance with the applicable institutional intellectual property policies;
(c) Study Inventions conceived or first reduced to practice jointly by employees, agents, or contractors of Sponsor, on the one hand, and employees, agents, or investigators of Veridian or a Network Site, on the other hand ("Joint Inventions"), shall be jointly owned by the applicable co-inventors' respective employers or institutions, subject to the terms of the IP Side Letter described in Section 8.3.
8.3 IP Side Letter. The Parties have executed a separate intellectual Property Side Letter concurrently with this Agreement, dated June 28, 2023, which governs the ownership, licensing, patent prosecution, patent maintenance, enforcement, and commercialization of Joint Inventions. The IP Side Letter is incorporated herein by reference. In the event of any conflict between the terms of this Agreement and the IP Side Letter with respect to Joint Inventions, the terms of the IP Side Letter shall control.
8.4 Detailed Provisions. Additional intellectual property provisions, including background intellectual property licenses, freedom to operate covenants, and invention disclosure procedures, are set forth in Exhibit G attached hereto and incorporated herein by reference.
ARTICLE IX — PUBLICATION RIGHTS
9.1 Right to Publish. The Parties recognize the importance of scientific publication and dissemination of clinical trial results to the medical and scientific community. Investigators shall have the right to publish or pre