EXHIBIT G
INTELLECTUAL PROPERTY AND PUBLICATION RIGHTS
Attached to and incorporated by reference into the Master Clinical Trial Agreement dated June 28, 2023 (the "Agreement") by and between Penterra Pharmaceuticals Corp., a Delaware corporation ("Sponsor"), and Veridian Health Research Network, Inc., a Delaware 501(c)(3) corporation ("Site Network").
Protocol: PPC-4871-III (CLARION — Clinical Assessment of Response with Longitudinal Investigation in ONcology)
ClinicalTrials.gov Identifier: NCT05928174
IND Number: IND 157823
Capitalized terms used but not defined herein shall have the meanings ascribed to them in the Agreement.
SECTION 1 — DEFINITIONS
As used in this Exhibit G, the following terms shall have the meanings set forth below:
1.1 "Background IP" means all intellectual property owned or controlled by a Party or its Affiliates prior to the Effective Date of the Agreement, or developed or acquired independently of and outside the scope of the Protocol. For the avoidance of doubt, Sponsor's Background IP includes, without limitation, all intellectual property relating to penterafenib (PPC-4871), its chemical structure, formulation, manufacturing processes, synthesis routes, mechanisms of action, pharmacological profiles, and all related know-how, trade secrets, patent applications, and issued patents existing as of the Effective Date. Site Network's and each Participating Site's Background IP includes all institutional research tools, methodologies, standard operating procedures, clinical research platforms, patient recruitment algorithms, and know-how existing prior to the Effective Date and developed independently of the Protocol. Background IP shall also include any intellectual property developed or acquired by a Party during the term of the Agreement that is not conceived or reduced to practice in the performance of activities under the Protocol.
1.2 "Clinical Trial Data" means all data, information, results, analyses, reports, case report forms (whether in paper or electronic form), source data verifications, electronic data capture records, laboratory data (including data generated by or received from Northbridge Bioanalytical Laboratories, Inc.), safety data (including adverse event reports, serious adverse event reports, and suspected unexpected serious adverse reaction reports), biomarker data, pharmacokinetic and pharmacodynamic data, imaging data, patient-reported outcome data, quality-of-life assessment data, genomic and proteomic data, and any and all other information of any kind generated, collected, compiled, or derived in the performance of activities under the Protocol at any Participating Site, whether in raw, processed, interim, final, or analyzed form. Clinical Trial Data shall include, without limitation, all data captured via the electronic data capture platform operated by Pinnacle Data Solutions, Inc. and all laboratory results generated by Northbridge Bioanalytical Laboratories, Inc. in connection with the Protocol. Clinical Trial Data shall not include a Participating Site's general medical records of trial subjects to the extent such records contain information unrelated to the Protocol.
1.3 "Confidential Information" shall have the meaning set forth in the Agreement and Exhibit F (Confidentiality and Data Protection Provisions) attached thereto. For purposes of this Exhibit G, the obligations of confidentiality with respect to Confidential Information shall remain in effect for a period of ten (10) years from the date of disclosure of such Confidential Information, except with respect to trade secrets, which shall remain confidential for so long as they retain their trade secret status under applicable law.
1.4 "Inventions" means any discovery, invention, improvement, enhancement, know-how, trade secret, process, technique, method, composition of matter, article of manufacture, software, algorithm, database, compilation, biomarker, diagnostic method, treatment protocol modification, or other intellectual property, whether or not patentable or copyrightable under applicable law, that is conceived, reduced to practice, developed, or first made in the performance of activities under the Protocol. For the avoidance of doubt, Inventions shall include any new or improved methods of patient stratification, novel biomarker correlations, diagnostic or prognostic methodologies, or therapeutic regimen modifications arising from activities conducted under the Protocol.
1.5 "Joint Invention" means any Invention that is jointly conceived or jointly reduced to practice by one or more employees, contractors, or agents of Sponsor (including, without limitation, employees or agents of Meridian Contract Research Organization, Inc. ("Meridian CRO") acting within the scope of their engagement by Sponsor) and one or more employees, contractors, or agents of Site Network, any Participating Site, or any Investigator. The determination of whether an Invention constitutes a Joint Invention shall be made in accordance with applicable United States patent law principles of inventorship.
1.6 "Patentable Subject Matter" means any Invention or discovery that may be the subject of a patent application under the patent laws of the United States (Title 35 of the United States Code) or any foreign jurisdiction, including any Invention that is novel, non-obvious, and useful, or that otherwise meets the requirements for patentability under applicable patent law.
1.7 "Publication" means any manuscript, article, abstract, poster, oral presentation, slide presentation, thesis, dissertation, lecture, webinar, blog post, social media communication, press release, or other public disclosure of Clinical Trial Data, Study Results, Inventions, or other information derived from activities conducted under the Protocol, whether in written, oral, electronic, visual, or any other form, and whether directed to scientific, medical, academic, investor, or general audiences. The term Publication shall include preliminary communications, interim analyses, and sub-group analyses, as well as final study results.
1.8 "Sole Invention" means any Invention that is conceived and reduced to practice solely by one or more employees, contractors, or agents of one Party (or, in the case of Sponsor, by employees or agents of Meridian CRO acting within the scope of their engagement by Sponsor) without the inventive contribution of any employee, contractor, or agent of the other Party.
1.9 "Study Results" means the analyzed and interpreted Clinical Trial Data, including, without limitation, efficacy analyses (overall survival, progression-free survival, objective response rate, duration of response, disease control rate, and time to response), safety analyses (incidence and severity of adverse events, dose-limiting toxicities, treatment-emergent adverse events, and laboratory abnormalities), biomarker correlative analyses, pharmacokinetic and pharmacodynamic analyses, patient-reported outcome analyses, and all statistical outputs, tables, figures, listings, and interpretive summaries prepared in connection with the Protocol.
SECTION 2 — OWNERSHIP OF CLINICAL TRIAL DATA
2.1 Exclusive Sponsor Ownership. All Clinical Trial Data generated in connection with Protocol PPC-4871-III shall be and remain the sole and exclusive property of Sponsor. All right, title, and interest in and to the Clinical Trial Data, including without limitation all Study Results, shall vest exclusively in Sponsor upon creation, without the need for any further act, document, or consideration. To the extent that any right, title, or interest in or to the Clinical Trial Data may vest in Site Network, any Participating Site, or any Investigator by operation of law or otherwise, Site Network hereby irrevocably assigns, and agrees to cause each Participating Site and each Investigator to irrevocably assign, to Sponsor all such right, title, and interest in and to the Clinical Trial Data, including all Study Results, effective upon creation thereof. Site Network shall ensure that each Individual Site Agreement and each Investigator Undertaking contains assignment language consistent with this Section 2.1.
2.2 No Site Ownership of Data. Neither Site Network, any Participating Site (including, without limitation, Graystone University Medical Center, Lakemont Medical Center, and any other site added to the Protocol pursuant to a Site Activation Order), nor any Investigator (including, without limitation, Global Principal Investigator Dr. Catherine Aldridge, Co-Principal Investigator Dr. Howard Matsuoka, and any sub-investigators listed in Form FDA 1572) shall have any ownership interest in the Clinical Trial Data or Study Results, except as expressly provided herein with respect to Publication rights set forth in Section 5 of this Exhibit G. Nothing in this Section 2.2 shall limit an Investigator's right to access a trial subject's medical records in accordance with applicable law and institutional policies for purposes of clinical care unrelated to the Protocol.
2.3 Sponsor's Right to Use. Sponsor shall have the unrestricted, perpetual, worldwide right to use, copy, analyze, modify, aggregate, compile, disclose, license, sublicense, transfer, and otherwise exploit the Clinical Trial Data and Study Results for any purpose whatsoever, including, without limitation, (a) regulatory submissions to the United States Food and Drug Administration ("FDA"), the European Medicines Agency, and any other regulatory authority worldwide; (b) marketing authorization applications, supplemental applications, and post-approval commitments; (c) post-marketing studies, registries, and real-world evidence generation; (d) scientific and medical publications, presentations, and communications; (e) internal research, development, and business planning; and (f) any other lawful purpose. Such rights shall be exercisable without further consent from, notice to, or payment to Site Network, any Participating Site, or any Investigator, except as expressly set forth in Section 5 of this Exhibit G with respect to Publication review and coordination.
2.4 Regulatory Filings. Sponsor shall have the exclusive right to reference and use all Clinical Trial Data and Study Results in connection with IND 157823 and any subsequent investigational new drug applications, new drug applications, biologics license applications, marketing authorization applications, supplemental applications, and any other regulatory submissions or filings worldwide. Site Network and each Participating Site hereby grant to Sponsor, and agree to cause their respective employees and agents to grant to Sponsor, the right of reference to any data, reports, or records generated or maintained at any Participating Site in connection with the Protocol for regulatory purposes.
2.5 Data Sharing with Third Parties. Sponsor may share Clinical Trial Data and Study Results with its authorized subcontractors, service providers, and agents, including, without limitation, Meridian Contract Research Organization, Inc. (Sponsor's contract research organization), Pinnacle Data Solutions, Inc. (electronic data capture and data management provider), and Northbridge Bioanalytical Laboratories, Inc. (central laboratory services provider), as well as with regulatory authorities, institutional review boards, data safety monitoring boards, and independent ethics committees, in each case subject to the confidentiality obligations set forth in the Agreement and Exhibit F and to appropriate contractual protections requiring such recipients to protect the Clinical Trial Data in a manner consistent with the terms of the Agreement. Nothing in this Section 2.5 shall limit Sponsor's obligation to comply with applicable privacy laws, including the Health Insurance Portability and Accountability Act of 1996 ("HIPAA"), as further addressed in Exhibit F.
SECTION 3 — SITE RECORD RETENTION
3.1 Retention Obligation. Each Participating Site shall retain all source documents, medical records, informed consent forms, regulatory correspondence, institutional review board records, and all other study-related records pertaining to the Protocol for a minimum of fifteen (15) years following completion of the study (projected study completion: August 2028, such that the minimum retention period would extend through August 2043) or for such longer period as may be required by applicable federal, state, or local law, regulation, or institutional policy, whichever is longer. In the event that Sponsor submits a new drug application or marketing authorization application based in whole or in part on Clinical Trial Data from Protocol PPC-4871-III, Sponsor may, by written notice to Site Network, extend the retention period for an additional period not to exceed five (5) years beyond the initial fifteen-year retention period.
3.2 Accessibility. During the retention period set forth in Section 3.1, Site Network and each Participating Site shall make all retained source documents and study-related records available to Sponsor and its authorized agents (including Meridian CRO) and to regulatory authorities, including the FDA, the Office for Human Research Protections, and any other applicable governmental or regulatory body, for audit, inspection, monitoring, and verification purposes upon reasonable notice (which shall be not less than five (5) business days' notice for Sponsor audits and such notice as may be required by applicable law for regulatory inspections). Site Network and each Participating Site shall provide adequate workspace, copying facilities, and personnel assistance to facilitate any such audit or inspection.
3.3 Transfer or Destruction. No Participating Site shall destroy, dispose of, or transfer custody of any source documents or study-related records without the prior written consent of Sponsor. In the event that a Participating Site intends to close its research operations, undergo a change of control, merge with or into another entity, or otherwise transfer its research operations, such Participating Site shall provide Sponsor with no less than one hundred eighty (180) calendar days' prior written notice and shall cooperate fully with Sponsor in the orderly transfer of all study-related records to Sponsor or to a successor institution designated by Sponsor. All costs associated with such transfer shall be borne by the Participating Site, unless otherwise agreed in writing by Sponsor.
3.4 Compliance with 21 C.F.R. Part 11. All electronic records and electronic signatures maintained by Site Network or any Participating Site in connection with the Protocol shall be maintained in compliance with 21 C.F.R. Part 11 (Electronic Records; Electronic Signatures) and the International Council for Harmonisation E6(R2) Guideline for Good Clinical Practice. Site Network shall ensure that each Participating Site implements and maintains appropriate controls, including validated systems, audit trails, access controls, and backup procedures, to ensure the integrity, reliability, and retrievability of all electronic records throughout the retention period.
SECTION 4 — BACKGROUND INTELLECTUAL PROPERTY
4.1 Retention of Background IP. Each Party shall retain all right, title, and interest in and to its respective Background IP. Nothing in the Agreement or this Exhibit G shall be construed as a transfer, assignment, or license of any Party's Background IP to the other Party, except as expressly set forth herein. The performance of activities under the Protocol shall not affect the ownership of any Party's Background IP, and no Party shall acquire any right, title, or interest in or to the other Party's Background IP by virtue of the Agreement, this Exhibit G, or the conduct of the Protocol.
4.2 Sponsor Background IP. Without limiting the generality of Section 4.1, Sponsor's Background IP includes, without limitation, all intellectual property relating to penterafenib (PPC-4871), including its chemical structure, molecular formula, salt forms, polymorphic forms, formulation, dosage forms, synthesis and manufacturing processes, process intermediates, analytical methods, mechanism of action, pharmacological activity, preclinical data, and all related know-how, trade secrets, proprietary information, and patent applications and issued patents, whether existing as of the Effective Date or developed independently of the Protocol during the term of the Agreement. Nothing in this Exhibit G shall diminish or otherwise affect Sponsor's exclusive ownership of, and all intellectual property rights in and to, penterafenib and all related compounds, formulations, and technologies.
4.3 Site Network Background IP. Without limiting the generality of Section 4.1, Site Network's Background IP includes, without limitation, all institutional research tools, clinical research methodologies, patient recruitment and retention protocols, standard operating procedures, quality management systems, research databases, and know-how developed by Site Network or any Participating Site independently of the Protocol and existing prior to the Effective Date or developed independently of the Protocol during the term of the Agreement. Nothing in this Exhibit G shall require Site Network or any Participating Site to disclose or license its Background IP to Sponsor except to the extent expressly necessary for the conduct of the Protocol.
4.4 No Implied Licenses. Except as expressly stated in this Exhibit G, no license, sublicense, right, or interest under any Party's Background IP is granted, implied, or arises by estoppel, exhaustion, or otherwise by virtue of the Agreement, this Exhibit G, or the performance of activities under the Protocol. Nothing in this Exhibit G shall be construed as granting to either Party any license or right to use the other Party's Background IP for purposes unrelated to the Protocol.
SECTION 5 — PUBLICATION RIGHTS
5.1 Investigator Right to Publish. Subject to the provisions of this Section 5, Investigators (including Global Principal Investigator Dr. Catherine Aldridge, M.D., Ph.D., of Graystone University Medical Center and Co-Principal Investigator Dr. Howard Matsuoka, M.D., of Lakemont Medical Center) and other Site Network academic personnel who have made substantive intellectual contributions to the design, conduct, analysis, or interpretation of the study shall have the right to publish or present Study Results in peer-reviewed journals, at scientific and medical conferences, and in academic presentations, consistent with the principles of academic freedom and the ethical obligations of medical researchers. The Parties acknowledge and agree that timely publication and dissemination of clinical trial results is in the interest of patients, the scientific community, and the public health, and nothing in this Section 5 is intended to suppress or unreasonably delay publication of clinically important information.
5.2 Advance Notice and Review Period. Prior to submitting any proposed Publication to a journal, conference, or other forum for consideration, the Investigator or Site Network (as applicable) shall provide Sponsor with a complete copy of the proposed Publication, including all text, tables, figures, supplementary materials, and appendices, at least sixty (60) calendar days in advance of the planned submission date (the "Review Period"). The Review Period shall commence upon Sponsor's actual receipt of the complete manuscript or presentation materials, as confirmed by written acknowledgment from Sponsor (which acknowledgment Sponsor shall provide within three (3) business days of receipt). If the Investigator or Site Network submits a revised or substantially modified version of the proposed Publication, a new sixty (60) calendar day Review Period shall commence upon Sponsor's receipt of such revised materials.
5.3 Sponsor Review Scope. During the sixty (60) calendar day Review Period, Sponsor shall review the proposed Publication solely for the following purposes:
(a) Identification and protection of Confidential Information. Sponsor shall identify any information in the proposed Publication that constitutes Confidential Information of Sponsor as defined in the Agreement and Exhibit F, including proprietary data, formulation details, manufacturing process information, or other information that is subject to confidentiality obligations.
(b) Identification of Patentable Subject Matter. Sponsor shall review the proposed Publication to determine whether it contains any Patentable Subject Matter that should be protected through the filing of patent applications prior to public disclosure.
(c) Verification of factual accuracy. Sponsor shall review the proposed Publication to verify the factual accuracy of the Clinical Trial Data and Study Results presented therein, including statistical analyses, data tables, and graphical representations.
(d) Ensuring compliance with regulatory requirements. Sponsor shall review the proposed Publication to ensure that it complies with applicable regulatory requirements, including FDA regulations, ICH Guidelines, and the requirements of ClinicalTrials.gov for results reporting.
Sponsor's review rights under this Section 5.3 shall not extend to editorial control over the scientific conclusions, interpretations, or opinions expressed by the Investigators, and Sponsor shall not exercise its review rights for the purpose of suppressing or censoring unfavorable or negative results.
5.4 Sponsor Comments. Sponsor shall provide its written comments, if any, to the Investigator or Site Network within the sixty (60) calendar day Review Period. Sponsor's comments shall identify with specificity the portions of the proposed Publication to which Sponsor objects and the basis for each objection (i.e., whether based on protection of Confidential Information, identification of Patentable Subject Matter, factual inaccuracy, or regulatory compliance). If Sponsor does not provide written comments within the Review Period, the proposed Publication shall be deemed approved for submission without modification, and the Investigator or Site Network shall be free to submit the Publication as proposed.
5.5 Removal of Confidential Information. The Investigator or Site Network shall remove from the proposed Publication any Confidential Information of Sponsor identified by Sponsor during the Review Period prior to submission of the Publication to any journal, conference, or other forum. In the event of a dispute between the Investigator or Site Network and Sponsor regarding whether specific information constitutes Confidential Information, the Parties shall attempt to resolve such dispute through good-faith discussion within ten (10) business days. If the Parties are unable to resolve such dispute, the matter shall be referred to the dispute resolution procedures set forth in Section 12 of this Exhibit G.
5.6 Patent Filing Delay. If Sponsor identifies Patentable Subject Matter in the proposed Publication during the Review Period, Sponsor may request in writing, prior to expiration of the sixty (60) calendar day Review Period, that submission of the Publication be delayed for an additional period of up to ninety (90) calendar days beyond the expiration of the initial Review Period (the "Patent Delay Period") to allow Sponsor to prepare and file one or more patent applications directed to the Patentable Subject Matter. Sponsor's written request shall identify with reasonable specificity the Patentable Subject Matter at issue and the jurisdictions in which Sponsor intends to file patent applications. The total maximum delay from the date of initial submission of the proposed Publication to Sponsor (including both the initial sixty (60) calendar day Review Period and the ninety (90) calendar day Patent Delay Period) shall therefore not exceed one hundred fifty (150) calendar days.
5.7 No Indefinite Delay. In no event shall Sponsor have the right to delay or prevent a Publication indefinitely. Upon expiration of the Patent Delay Period (if invoked pursuant to Section 5.6) or the initial sixty (60) calendar day Review Period (if no Patent Delay Period is requested), the Investigator or Site Network shall be free to submit the Publication for consideration by the intended journal, conference, or other forum, provided that all Confidential Information of Sponsor has been removed in accordance with Section 5.5. The Parties acknowledge that indefinite suppression or delay of Publication would be inconsistent with the principles of academic freedom and the ethical obligations of clinical researchers, and nothing in this Exhibit G shall be interpreted to permit such suppression or delay.
5.8 Multi-Center Publications. In the case of multi-center Publications involving data from more than one Participating Site, the Investigators and Site Network shall coordinate with Sponsor regarding authorship and timing to ensure that multi-center results are published in an orderly manner that does not compromise the integrity of the overall study analysis. Sponsor shall have the right to coordinate the timing of multi-center publications with the publication of the primary study results, and to request that single-site publications or sub-analyses be delayed until after publication of the primary multi-center results, provided that any such delay shall not exceed the one hundred fifty (150) calendar day maximum delay period specified in Sections 5.6 and 5.7. Authorship of multi-center publications shall be determined in accordance with the International Committee of Medical Journal Editors (ICMJE) criteria for authorship. Sponsor shall not require "ghost authorship" or the inclusion of any individual as an author who does not meet the ICMJE criteria.
5.9 Acknowledgments. All Publications shall include appropriate acknowledgment of Sponsor's funding and support of the study, including (a) identification of the study as a Sponsor-funded clinical trial sponsored by Penterra Pharmaceuticals Corp.; (b) reference to ClinicalTrials.gov Identifier NCT05928174; (c) the IND number (IND 157823); and (d) such other disclosures as may be required by the applicable journal, conference, or regulatory authority. Publications shall also include disclosures of any financial relationships between the Investigators and Sponsor, in accordance with ICMJE disclosure requirements and the policies of the publishing journal or conference.
5.10 No Suppression. Sponsor shall not have the right to suppress, censor, or prevent a Publication for reasons other than the protection of Confidential Information and Patentable Subject Matter as expressly set forth in this Section 5. For the avoidance of doubt, Sponsor shall not suppress or seek to suppress any Publication on the basis that the Study Results or the Investigators' conclusions are unfavorable to Sponsor, negative, inconclusive, or otherwise inconsistent with Sponsor's commercial interests. The Parties acknowledge their shared commitment to transparency in clinical research and to compliance with applicable requirements for public disclosure of clinical trial results, including the requirements of Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) and 42 C.F.R. Part 11.
5.11 Investigator Grants. Investigator grants for academic publication support, totaling One Million Five Hundred Thousand Dollars ($1,500,000) as set forth in Exhibit B (Budget and Payment Schedule), shall be disbursed upon acceptance of manuscripts for peer-reviewed publication in accordance with the milestone payment schedule set forth in Exhibit B. All such investigator grants shall be determined at fair market value for the services rendered and shall comply with Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)) safe harbor requirements and Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h) reporting obligations, as further set forth in Exhibit H (Regulatory Compliance Representations and Covenants). Sponsor shall report all such payments in accordance with Open Payments requirements, and each Investigator receiving publication support grants shall cooperate with Sponsor in providing information necessary for accurate and timely reporting.
SECTION 6 — INVENTIONS
6.1 Sole Inventions by Sponsor. All Sole Inventions conceived and reduced to practice solely by employees, contractors, or agents of Sponsor (including, without limitation, employees or agents of Meridian CRO acting within the scope of their engagement by Sponsor) shall be the sole and exclusive property of Sponsor. Neither Site Network, any Participating Site, nor any Investigator shall have any ownership interest, license right, or other claim with respect to any such Sole Invention, except as may be expressly agreed in a separate written agreement executed by the Parties.
6.2 Sole Inventions by Site Network/Sites/Investigators. All Sole Inventions conceived and reduced to practice solely by employees, contractors, or agents of Site Network, a Participating Site, or an Investigator, without any inventive contribution by employees, contractors, or agents of Sponsor or Meridian CRO, shall be the sole and exclusive property of Site Network or the applicable Participating Site or Investigator, as determined under the applicable institutional intellectual property policies of Site Network or such Participating Site; provided, however, that if any such Sole Invention (a) incorporates, is derived from, or is based upon Clinical Trial Data or Study Results owned by Sponsor pursuant to Section 2, or (b) incorporates or is derived from Confidential Information of Sponsor, then Sponsor shall receive, and Site Network or the applicable Participating Site or Investigator hereby grants to Sponsor, a non-exclusive, worldwide, royalty-free, perpetual, irrevocable, fully sublicensable license to make, have made, use, import, offer for sale, sell, and otherwise exploit such Sole Invention for any purpose, without further consent from or payment to Site Network, the applicable Participating Site, or the applicable Investigator.
6.3 Joint Inventions. Ownership of, and rights with respect to, Joint Inventions shall be governed by the intellectual Property Side Letter executed concurrently with the Agreement on June 28, 2023 (the "IP Side Letter"), which is incorporated herein by reference. The IP Side Letter sets forth the Parties' agreement with respect to the allocation of ownership of Joint Inventions, the responsibilities and costs of patent prosecution for Joint Inventions, the licensing terms applicable to each Party's interest in Joint Inventions, and the commercialization rights, revenue sharing, and related obligations of the Parties with respect to Joint Inventions. In the event of any conflict between this Exhibit G and the IP Side Letter with respect to Joint Inventions, the IP Side Letter shall control.
6.4 Obligation to Disclose. Each Party shall promptly disclose to the other Party any Invention (whether Sole or Joint) conceived or reduced to practice during the performance of activities under the Protocol. Such disclosure shall be made in writing within thirty (30) calendar days of conception or first reduction to practice, and shall include a reasonably detailed description of the Invention, the names of all individuals who participated in the conception or reduction to practice of the Invention, and such other information as may be reasonably necessary for the receiving Party to evaluate the Invention. Site Network shall ensure that all Participating Sites and Investigators are informed of this disclosure obligation and shall include appropriate provisions in each Individual Site Agreement and each Investigator Undertaking to ensure compliance.
6.5 Assignment and Cooperation. Each Party shall cause its employees, contractors, and agents to execute all documents and instruments and take all actions reasonably necessary to perfect, evidence, and protect the ownership rights set forth in this Section 6, including, without limitation, invention assignment agreements, patent applications, declarations, powers of attorney, and any other documents required by applicable patent offices or courts. Each Party shall bear its own costs in connection with the execution and delivery of such documents, except as otherwise expressly provided herein or in the IP Side Letter. Each Party hereby irrevocably appoints the other Party as its attorney-in-fact, coupled with an interest, for the sole purpose of executing such documents and taking such actions on behalf of the appointing Party in the event that the appointing Party fails or refuses to do so within thirty (30) days after written request.
SECTION 7 — PATENT PROSECUTION
7.1 Sponsor Sole Inventions. Sponsor shall have the sole right and responsibility to prepare, file, prosecute, and maintain patent applications and patents covering Sole Inventions owned by Sponsor in any and all jurisdictions worldwide, at Sponsor's sole cost and expense. Sponsor shall have sole discretion regarding the scope, strategy, and conduct of patent prosecution for Sponsor's Sole Inventions, and shall not be obligated to consult with or seek the approval of Site Network or any Participating Site or Investigator in connection therewith.
7.2 Site Network/Investigator Sole Inventions. Site Network or the applicable Participating Site or Investigator shall have the right to prepare, file, prosecute, and maintain patent applications and patents covering their respective Sole Inventions in any jurisdiction worldwide, at their own cost and expense; provided, however, that if any such Sole Invention is subject to a license to Sponsor under Section 6.2, the following conditions shall apply:
(a) Site Network or the applicable Participating Site or Investigator shall provide Sponsor with a copy of each proposed patent application at least thirty (30) calendar days prior to filing, and Sponsor shall have the right to review and comment on such application;
(b) Site Network or the applicable Participating Site or Investigator shall give reasonable consideration to Sponsor's comments and shall not unreasonably refuse to incorporate Sponsor's suggested claim amendments or prosecution strategies;
(c) Site Network or the applicable Participating Site or Investigator shall keep Sponsor reasonably informed of the status of patent prosecution, including providing copies of all substantive communications with patent offices; and
(d) If Site Network or the applicable Participating Site or Investigator determines not to file, continue prosecution of, or maintain any patent application or patent covering such Sole Invention, it shall provide Sponsor with at least sixty (60) calendar days' prior written notice, and Sponsor shall have the right (but not the obligation) to assume prosecution and maintenance of such application or patent at Sponsor's cost and expense.
7.3 Joint Inventions. Patent prosecution responsibilities, costs, strategies, and decision-making authority with respect to Joint Inventions shall be governed by the terms and conditions set forth in the IP Side Letter. To the extent not addressed by the IP Side Letter, the Parties shall cooperate in good faith to determine the appropriate patent prosecution strategy for any Joint Invention.
7.4 Cooperation. Each Party shall cooperate with the other Party and with patent counsel in connection with the preparation, filing, prosecution, and maintenance of patent applications and patents under this Section 7, including, without limitation, providing reasonable access to inventors for interviews and declarations, executing all necessary documents (including assignments, declarations, and powers of attorney), and providing relevant technical information and prior art. The prosecuting Party shall reimburse the cooperating Party for its reasonable out-of-pocket expenses incurred in providing such cooperation, unless otherwise agreed in writing.
SECTION 8 — LICENSE GRANTS
8.1 Limited License to Sites. Sponsor hereby grants to Site Network and each Participating Site a limited, non-exclusive, non-transferable, non-sublicensable, revocable license to use Sponsor's Confidential Information and Protocol-related materials (including the Protocol, the Investigator's Brochure, case report forms, and study-specific instructions) solely to the extent necessary to perform the clinical trial activities specified in the Protocol at the Participating Sites. This license shall not extend to any use of Sponsor's Confidential Information or Protocol-related materials for any purpose other than the conduct of the Protocol, including, without limitation, any commercial, marketing, or non-Protocol research purpose.
8.2 Revocation Upon Termination. The license granted under Section 8.1 shall automatically terminate, without the need for any further notice or action by Sponsor, upon the earlier of (a) termination or expiration of the Agreement, (b) termination or expiration of the applicable Individual Site Agreement, or (c) termination of a Participating Site's participation in the Protocol; provided, however, that such termination shall be subject to the one hundred twenty (120) calendar day wind-down period set forth in the Agreement, during which the license shall continue solely to the extent necessary to complete ongoing patient visits, ensure patient safety, and effect an orderly transition of study activities. Upon expiration of the wind-down period, Site Network and each affected Participating Site shall promptly return or destroy all Sponsor Confidential Information and Protocol-related materials in accordance with the provisions of Exhibit F.
8.3 No Other Licenses. Except as expressly set forth in this Section 8 and in Section 6.2 (license to Sponsor with respect to certain Site Network/Investigator Sole Inventions), no license, sublicense, right, or interest under any intellectual property of either Party is granted, implied, or arises by estoppel, exhaustion, or otherwise by virtue of the Agreement, this Exhibit G, or the performance of activities under the Protocol.
SECTION 9 — COMPLIANCE WITH REGULATORY REQUIREMENTS
9.1 Financial Disclosure. All Inventions and intellectual property-related disclosures under this Exhibit G shall be subject to the financial disclosure requirements of 21 C.F.R. Part 54 (Financial Disclosure by Clinical Investigators), as further set forth in Exhibit H (Regulatory Compliance Representations and Covenants) and the Financial Disclosure Certification executed by each Investigator. Each Investigator shall disclose any financial interest in Sponsor or any entity with a financial interest in the outcome of the study that could be affected by the Investigator's inventive activities, and Site Network shall promptly notify Sponsor of any changes in such financial interests.
9.2 FDA Requirements. All activities relating to Inventions, Clinical Trial Data, and Study Results under this Exhibit G shall comply with all applicable regulations and guidance of the FDA, including, without limitation, 21 C.F.R. Part 11 (Electronic Records; Electronic Signatures), 21 C.F.R. Part 312 (Investigational New Drug Application), and the International Council for Harmonisation E6(R2) Guideline for Good Clinical Practice, as well as any applicable requirements of the Office for Human Research Protections, the Common Rule (45 C.F.R. Part 46), and applicable state and local laws and regulations.
9.3 Anti-Kickback and Sunshine Act. All payments made under or in connection with this Exhibit G, including, without limitation, investigator grants and publication support payments under Section 5.11, shall comply with the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)) and applicable safe harbor regulations (42 C.F.R. § 1001.952), and shall be reported in accordance with the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h) and the implementing regulations at 42 C.F.R. Parts 402 and 403 (Open Payments), as further specified in Exhibit H. Sponsor shall maintain records of all such payments and shall make such records available to Site Network and applicable Investigators upon reasonable request.
SECTION 10 — REPRESENTATIONS AND WARRANTIES
10.1 Sponsor Representations. Sponsor represents and warrants to Site Network that: (a) it has the full corporate right, power, and authority to enter into this Exhibit G and to grant the licenses set forth herein; (b) the execution, delivery, and performance of this Exhibit G do not and will not conflict with any agreement, instrument, or obligation to which Sponsor is a party or by which it is bound; (c) to the best of its knowledge as of the Effective Date, the conduct of the Protocol as described in the Protocol does not infringe any valid and enforceable intellectual property rights of any third party; and (d) it has not received any written notice from any third party alleging that the conduct of the Protocol infringes any third-party intellectual property rights. The foregoing representations and warranties are made as of the Effective Date and shall be deemed repeated as of each date on which a new Participating Site is activated under the Protocol.
10.2 Site Network Representations. Site Network represents and warrants to Sponsor that: (a) it has institutional policies in place that require its employees, contractors, and investigators to assign to Site Network (or, as directed, to Sponsor) all inventions and intellectual property as may be necessary to comply with the obligations set forth in this Exhibit G; (b) it has the full corporate right, power, and authority to enter into this Exhibit G and to make the assignments and grant the licenses set forth herein; (c) it will ensure that all Participating Sites and Investigators comply with the obligations set forth in this Exhibit G, including, without limitation, the disclosure, assignment, and cooperation obligations set forth in Section 6; and (d) it will include in each Individual Site Agreement provisions consistent with this Exhibit G requiring each Participating Site to comply with the intellectual property and publication obligations set forth herein.
10.3 Investigator Acknowledgment. Each Investigator, by execution of the Investigator Undertaking in the form attached to the Agreement as Exhibit I, confirms and acknowledges that he or she has read, understands, and agrees to comply with the intellectual property, data ownership, and publication obligations set forth in this Exhibit G. Each Investigator further confirms that he or she is not aware of any conflict of interest, prior obligation, or third-party agreement that would prevent or impair compliance with this Exhibit G. Site Network shall ensure that each Investigator executes the Investigator Undertaking prior to commencing any activities under the Protocol.
SECTION 11 — TERM AND SURVIVAL
11.1 Term. This Exhibit G shall be effective as of the Effective Date of the Agreement (July 18, 2023) and shall remain in full force and effect for the duration of the Agreement, including any extensions or renewals thereof.
11.2 Survival. The following provisions of this Exhibit G shall survive the termination or expiration of the Agreement for any reason, and shall remain in full force and effect in accordance with their terms:
(a) Section 2 (Ownership of Clinical Trial Data), which shall survive in perpetuity;
(b) Section 3 (Site Record Retention), which shall survive for the applicable retention period set forth therein;
(c) Section 4 (Background intellectual Property), which shall survive in perpetuity;
(d) Section 5 (Publication Rights), which shall survive for so long as any Investigator or Site Network academic personnel retains the right to publish Study Results, subject to continued compliance with the review, delay, and Confidential Information removal provisions set forth therein;
(e) Section 6 (Inventions), which shall survive in perpetuity with respect to the ownership, assignment, and licensing provisions set forth therein;
(f) Section 7 (Patent Prosecution), which shall survive for so long as any patent application or patent subject to such provisions remains pending or in force;
(g) Section 8 (License Grants), to the extent expressly stated to survive termination in Section 8.2 and to the extent that the license granted to Sponsor under Section 6.2 is stated to be perpetual and irrevocable;
(h) Section 10 (Representations and Warranties), which shall survive for the applicable statute of limitations period;
(i) Section 12 (Dispute Resolution), which shall survive in perpetuity; and
(j) Section 13 (Miscellaneous), which shall survive to the extent necessary to give effect to the surviving provisions.
SECTION 12 — DISPUTE RESOLUTION
12.1 Governing Law. This Exhibit G shall be governed by and construed in accordance with the laws of the State of New York, without regard to its conflicts-of-law principles that would require or permit the application of the laws of any other jurisdiction. The United Nations Convention on Contracts for the International Sale of Goods shall not apply to this Exhibit G.
12.2 Dispute Resolution Procedures. Any dispute, controversy, or claim arising out of or relating to this Exhibit G, or the breach, termination, or invalidity thereof, shall be resolved in accordance with the dispute resolution procedures set forth in the Agreement, which are incorporated herein by reference and summarized as follows:
(a) Designated Representative Negotiation. The Parties shall first attempt to resolve any such dispute through good-faith negotiation between designated senior representatives of each Party for a period of thirty (30) calendar days following written notice of the dispute.
(b) Mediation. If the dispute is not resolved through designated representative negotiation within the thirty (30) day period specified in Section 12.2(a), either Party may submit the dispute to mediation administered by the American Arbitration Association ("AAA") under its Commercial Mediation Rules then in effect. The mediation shall be conducted in New York, New York, and shall continue for a period of sixty (60) calendar days from the commencement of mediation, unless the Parties mutually agree to extend such period.
(c) Binding Arbitration. If the dispute is not resolved through mediation within the sixty (60) day period specified in Section 12.2(b), either Party may submit the dispute to final and binding arbitration administered by the AAA under its Commercial Arbitration Rules then in effect. The arbitration shall be conducted in New York, New York, before a panel of three (3) arbitrators selected in accordance with the AAA rules. The arbitrators shall have expertise in pharmaceutical industry intellectual property matters. The arbitral award shall be final and binding on the Parties, and judgment thereon may be entered in any court of competent jurisdiction.
12.3 Injunctive Relief. Notwithstanding the foregoing dispute resolution procedures, either Party may seek temporary, preliminary, or permanent injunctive relief or other equitable relief from the state and federal courts located in New York County, New York, to prevent or restrain any actual or threatened unauthorized disclosure, use, or misappropriation of Confidential Information, Clinical Trial Data, or intellectual property, or any breach of the obligations set forth in this Exhibit G that would cause irreparable harm for which monetary damages would be an inadequate remedy. Each Party hereby consents to the exclusive jurisdiction of the state and federal courts located in New York County, New York, for purposes of any action seeking injunctive or equitable relief under this Section 12.3, and hereby waives any objection to venue or jurisdiction therein.
SECTION 13 — MISCELLANEOUS
13.1 Entire Agreement. This Exhibit G, together with the Agreement, the IP Side Letter dated June 28, 2023, and the other Exhibits and Schedules to the Agreement, constitutes the entire agreement between the Parties with respect to the subject matter hereof and supersedes all prior and contemporaneous agreements, understandings, negotiations, discussions, representations, and warranties, whether written or oral, with respect to the intellectual property and publication matters addressed herein.
13.2 Amendments. This Exhibit G may not be amended, modified, supplemented, or waived except by a written instrument that expressly references this Exhibit G and is signed by duly authorized representatives of both Parties. No course of dealing, usage of trade, or course of performance shall be deemed to modify, supplement, or waive any provision of this Exhibit G.
13.3 Severability. If any provision of this Exhibit G is held to be invalid, illegal, or unenforceable by a court of competent jurisdiction or an arbitral tribunal, such provision shall be modified to the minimum extent necessary to make it valid, legal, and enforceable, and the remaining provisions of this Exhibit G shall remain in full force and effect and shall not be affected or impaired thereby.
13.4 Notices. All notices, requests, demands, and other communications required or permitted under this Exhibit G shall be in writing and shall be given in accordance with the notice provisions of the Agreement, addressed as follows:
If to Sponsor:
Penterra Pharmaceuticals Corp. 200 Biopharma Boulevard, Suite 1400 Princeton, NJ 08540
Attention: Nathaniel Briggs, Esq., Vice President & General Counsel
With a copy (which shall not constitute notice) to:
Penterra Pharmaceuticals Corp. 200 Biopharma Boulevard, Suite 1400 Princeton, NJ 08540
Attention: Rebecca Liang, Esq., Associate General Counsel, Clinical Affairs
If to Site Network:
Veridian Health Research Network, Inc. 750 Research Parkway, 8th Floor Philadelphia, PA 19104
Attention: Gregory Callahan, Esq., Vice President, Legal & Compliance
Either Party may change its address for notices by providing written notice to the other Party in accordance with this Section 13.4.
13.5 No Third-Party Beneficiaries. Except for the rights of individual Investigators under Section 5 (Publication Rights), which are intended to confer enforceable rights on such Investigators as express third-party beneficiaries of this Exhibit G, this Exhibit G does not create, and shall not be construed to create, any rights, claims, or benefits in or for any person or entity that is not a Party hereto.
13.6 Cross-References. This Exhibit G shall be read and interpreted in conjunction with the IP Side Letter dated June 28, 2023, and the following Exhibits and Schedules to the Agreement, each of which is incorporated herein by reference to the extent relevant to the subject matter of this Exhibit G:
• Exhibit B — Budget and Payment Schedule (including investigator grant payment milestones);
• Exhibit D — Subject-Injury Indemnification Provisions;
• Exhibit F — Confidentiality and Data Protection Provisions;
• Exhibit H — Regulatory Compliance Representations and Covenants (including Anti-Kickback Statute, Sunshine Act, and financial disclosure obligations); and
• Exhibit I — Form of Investigator Undertaking.
In the event of any conflict between the provisions of this Exhibit G and the provisions of the Agreement, the provisions of the Agreement shall control, except with respect to matters specifically and exclusively addressed in this Exhibit G. In the event of any conflict between this Exhibit G and the IP Side Letter with respect to Joint Inventions, the IP Side Letter shall control.
[SIGNATURE PAGE FOLLOWS]
SIGNATURE PAGE TO EXHIBIT G INTELLECTUAL PROPERTY AND PUBLICATION RIGHTS
IN WITNESS WHEREOF, the undersigned authorized representatives of the Parties have executed and delivered this Exhibit G as of June 28, 2023, as part of the Agreement.
PENTERRA PHARMACEUTICALS CORP.
By: ________
Name: Nathaniel Briggs, Esq.
Title: Vice President & General Counsel
Date: ________
VERIDIAN HEALTH RESEARCH NETWORK, INC.
By: ________
Name: Franklin Osei, M.D., Ph.D.
Title: President & Chief Executive Officer
Date: ________
ACKNOWLEDGED BY LEAD PARTICIPATING SITE:
GRAYSTONE UNIVERSITY MEDICAL CENTER
By: ________
Name: William Corwin, M.D.
Title: President
Date: ________
CONFIDENTIAL — This document contains confidential and proprietary information of Penterra Pharmaceuticals Corp. and Veridian Health Research Network, Inc. and is subject to the confidentiality provisions of the Agreement and Exhibit F.