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INTELLECTUAL PROPERTY SIDE LETTER

Execution Version

June 28, 2023

This intellectual Property Side Letter (this "Agreement" or "Side Letter") is entered into as of June 28, 2023 (the "Effective Date"), concurrently with and supplemental to that certain Master Clinical Trial Agreement dated June 28, 2023 (the "MCTA"), by and between the parties identified herein.

Protocol Reference: Protocol PPC-4871-III (CLARION — Clinical Assessment of Response with Longitudinal Investigation in ONcology)

ClinicalTrials.gov Identifier: NCT05928174

IND Number: IND 157823

PARTIES

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

and

VERIDIAN HEALTH RESEARCH NETWORK, INC. ("Site Network" or "Veridian"), a not-for-profit corporation organized and existing under the laws of the State of Delaware and recognized as tax-exempt under Section 501(c)(3) of the Internal Revenue Code of 1986, as amended, with its principal offices located at 750 Research Parkway, 8th Floor, Philadelphia, Pennsylvania 19104.

Penterra and Veridian are referred to herein collectively as the "Parties" and each individually as a "Party."

RECITALS

WHEREAS, Sponsor and Site Network have entered into that certain Master Clinical Trial Agreement dated June 28, 2023 (the "MCTA"), governing the conduct of Protocol PPC-4871-III (CLARION), a Phase III, randomized, double-blind, placebo-controlled clinical trial of penterafenib (PPC-4871), an oral multi-kinase inhibitor, in subjects with advanced hepatocellular carcinoma ("HCC");

WHEREAS, the MCTA provides for the participation of thirty-eight (38) Veridian Network academic medical centers and affiliated research sites across fourteen (14) states, with a total deal value of Eighty Million Dollars ($80,000,000) covering site fees, per-patient payments, investigator grants, and operational costs over the projected forty-two (42) month enrollment period;

WHEREAS, the MCTA contemplates the execution of this intellectual Property Side Letter to address ownership, licensing, and prosecution of intellectual property and inventions arising in connection with the CLARION trial, as referenced in Section 12.4 of the MCTA and Exhibit G thereto;

WHEREAS, the Parties desire to set forth their respective rights and obligations with respect to pre-existing intellectual property, study data, inventions conceived or reduced to practice during the conduct of the trial, and patent prosecution procedures, in a comprehensive manner that supplements and, where applicable, supersedes the summary provisions contained in Exhibit G of the MCTA;

WHEREAS, this Side Letter is intended to be read and construed together with the MCTA, and in the event of any conflict between this Side Letter and the MCTA with respect to intellectual property matters, this Side Letter shall control; and

NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth herein and the obligations undertaken in the MCTA, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:

ARTICLE 1 — DEFINITIONS

Section 1.1 — Defined Terms

As used in this Agreement, the following terms shall have the meanings set forth below:

(a) "Agreement" means this intellectual Property Side Letter, including any amendments, modifications, or supplements hereto executed in writing by both Parties.

(b) "Background IP" or "Pre-Existing IP" means all intellectual property, including but not limited to patents, patent applications, trade secrets, know-how, copyrights, data, materials, compounds, formulations, software, databases, algorithms, and proprietary information, that is (i) owned or controlled by a Party as of the Effective Date, or (ii) developed independently by a Party outside the scope of the CLARION trial, whether before, during, or after the term of the MCTA, and without use of or reference to the other Party's Confidential Information, Study Data, or intellectual property. For the avoidance of doubt, Background IP includes all intellectual property that a Party can demonstrate, through contemporaneous written records, was in its possession or under its control prior to the Effective Date or was independently developed without reference to activities conducted under the Protocol.

(c) "Confidential Information" has the meaning ascribed to such term in the MCTA and Exhibit F thereto (Confidentiality and Data Protection Provisions), and shall be subject to a confidentiality term of ten (10) years from the date of disclosure.

(d) "Investigational Product" means penterafenib (PPC-4871), the oral multi-kinase inhibitor that is the investigational compound studied under the Protocol, including all formulations, dosage forms, and delivery mechanisms thereof.

(e) "Invention" means any discovery, improvement, process, method, composition of matter, article of manufacture, technique, device, algorithm, software, biological material, biomarker, assay, or know-how, whether or not patentable or copyrightable, that is conceived or first reduced to practice in connection with or arising out of activities conducted under the Protocol. The term Invention shall be broadly construed and shall include, without limitation, new uses of the Investigational Product, diagnostic methods, patient selection criteria, formulation improvements, and bioanalytical methodologies developed in the course of Protocol activities.

(f) "Joint Invention" means an Invention that is conceived or reduced to practice jointly by (i) personnel of Sponsor, including any contract research organization ("CRO") personnel, consultants, or agents acting on Sponsor's behalf, and (ii) personnel of Site Network, a participating site institution, or an investigator, where inventorship is determined in accordance with applicable U.S. patent law as set forth in Section 4.6 of this Agreement.

(g) "MCTA" means the Master Clinical Trial Agreement dated June 28, 2023, between Penterra and Veridian, including all exhibits, schedules, appendices, amendments, and Individual Site Agreements (joinders) executed thereunder.

(h) "Net Sales" means, for purposes of royalty calculations under Section 4.5, the gross revenues received by Penterra, its affiliates, and its sublicensees from sales of products incorporating or covered by a valid claim of a patent issuing from a Joint Invention, less the following customary deductions to the extent actually incurred and directly attributable to such sales: (i) trade, quantity, and cash discounts actually allowed; (ii) credits, allowances, and refunds for returns; (iii) governmental rebates and chargebacks, including without limitation Medicaid, Medicare, and Tricare rebates and chargebacks required by applicable law; (iv) distribution fees and commissions paid to independent third-party distributors; and (v) sales taxes, value-added taxes, excise taxes, import/export duties, and other governmental charges imposed on such sales (excluding income taxes). Net Sales shall be calculated in accordance with United States Generally Accepted Accounting Principles ("GAAP"), consistently applied.

(i) "Patent Rights" means all patents and patent applications worldwide, including without limitation provisional applications, utility applications, continuations, continuations-in-part (to the extent claiming subject matter disclosed in the parent application), divisionals, reissues, reexaminations, inter partes reviews, supplementary protection certificates, patent term extensions, and any foreign counterparts or equivalents of any of the foregoing.

(j) "Protocol" means Protocol PPC-4871-III (CLARION — Clinical Assessment of Response with Longitudinal Investigation in ONcology), as amended from time to time in accordance with applicable regulatory requirements and the terms of the MCTA.

(k) "Site Personnel" means investigators (including Global Principal Investigator Dr. Catherine Aldridge and Co-Principal Investigator Dr. Howard Matsuoka), sub-investigators, research coordinators, pharmacists, study nurses, data managers, and other staff employed by or affiliated with Veridian Network participating sites who perform activities under the Protocol. For the avoidance of doubt, Site Personnel includes all individuals listed in Form FDA 1572 (Statement of Investigator) and any amendments thereto submitted in connection with the Protocol.

(l) "Sponsor IP" means all intellectual property owned or controlled by Penterra, including without limitation all intellectual property relating to penterafenib (PPC-4871), the Protocol, Sponsor's proprietary formulations, manufacturing processes, analytical methods, regulatory filings (including IND 157823 and any supplements thereto), clinical study reports, and marketing applications, together with all trade secrets, know-how, and proprietary information embodied therein.

(m) "Study Data" has the meaning ascribed to such term in the MCTA, and includes all clinical trial data, case report forms (electronic and paper), source data verifications, electronic data capture records, biomarker data (including genomic, proteomic, and metabolomic data), pharmacokinetic and pharmacodynamic data, safety data (including adverse event reports, serious adverse event reports, and suspected unexpected serious adverse reaction reports), imaging data, patient-reported outcome data, quality-of-life assessments, and any analyses, compilations, or reports generated in connection with the Protocol.

Section 1.2 — Interpretation

Capitalized terms used but not otherwise defined in this Agreement shall have the meanings ascribed to such terms in the MCTA. References to Exhibits in this Agreement include, where applicable, cross-references to exhibits of the MCTA, including Exhibit G (Intellectual Property and Publication Rights) and Exhibit F (Confidentiality and Data Protection Provisions). Unless the context otherwise requires, (a) words importing the singular include the plural and vice versa, (b) references to "including" or "includes" shall mean "including without limitation" or "includes without limitation," (c) references to "herein," "hereof," "hereunder," and similar terms refer to this Agreement as a whole and not to any particular section or provision, and (d) references to any statute, regulation, or rule include all amendments, modifications, and replacements thereof and all rules and regulations promulgated thereunder.

ARTICLE 2 — OWNERSHIP OF PRE-EXISTING INTELLECTUAL PROPERTY

Section 2.1 — Retention of Pre-Existing IP

Each Party shall retain all right, title, and interest in and to its Pre-Existing IP. Nothing in this Side Letter, the MCTA, or any exhibit, schedule, or amendment thereto shall be construed as transferring, assigning, or conveying ownership of Pre-Existing IP from one Party to the other, whether by implication, estoppel, or otherwise. Without limiting the generality of the foregoing:

(a) Penterra retains all right, title, and interest in and to penterafenib (PPC-4871), including without limitation its chemical composition, molecular structure, polymorphic forms, salt forms, formulations, dosage forms, manufacturing processes, analytical reference standards, and all regulatory filings associated therewith, including IND 157823, any investigator's brochure, and all supplements, amendments, and correspondence with the United States Food and Drug Administration ("FDA") and foreign regulatory authorities.

(b) Veridian and its member institutions retain all right, title, and interest in and to their respective pre-existing research methodologies, institutional standard operating procedures, proprietary patient recruitment platforms, clinical database architectures, institutional biobanking protocols, educational curricula, and any other proprietary systems or processes that existed prior to the Effective Date or that were developed independently of the Protocol.

Section 2.2 — Limited License to Pre-Existing IP

Each Party hereby grants to the other Party a non-exclusive, non-transferable, royalty-free license to use the granting Party's Pre-Existing IP solely to the extent necessary for the performance of such other Party's obligations under the Protocol and the MCTA. This license is limited in scope to activities directly related to the conduct of the CLARION trial and does not extend to any use beyond such activities. The license granted under this Section 2.2 shall terminate automatically upon the expiration or termination of the MCTA, subject to the survival provisions set forth in the MCTA, including the one hundred twenty (120) day wind-down period for subject safety obligations. Neither Party shall have the right to sublicense the Pre-Existing IP of the other Party except to approved subcontractors listed in Exhibit K of the MCTA — namely, Meridian Contract Research Organization, Inc., Pinnacle Data Solutions, Inc., and Northbridge Bioanalytical Laboratories, Inc. — and only with the prior written consent of the granting Party, such consent not to be unreasonably withheld, conditioned, or delayed.

ARTICLE 3 — OWNERSHIP OF STUDY DATA

Section 3.1 — Exclusive Sponsor Ownership

Penterra shall retain exclusive ownership of all Study Data generated in connection with the CLARION trial, consistent with the terms of the MCTA and Exhibit G thereto. For the avoidance of doubt, Study Data includes, without limitation, all clinical trial data, electronic data capture records (maintained on the Pinnacle Data Solutions, Inc. platform), centralized laboratory results (generated by Northbridge Bioanalytical Laboratories, Inc.), safety data, pharmacovigilance reports, biostatistical analyses (managed by Meridian Contract Research Organization, Inc.), interim analyses, final clinical study reports, and any derivative data sets or compilations. All Study Data shall be deemed Confidential Information of Penterra and shall be treated in accordance with the confidentiality obligations set forth in Article 7 of this Agreement and Exhibit F of the MCTA.

Section 3.2 — Site Record Retention

Veridian and each participating site institution shall retain source documents and site-level records in accordance with the MCTA's record retention obligations for a minimum of fifteen (15) years after study completion (currently projected for August 2028) or for such longer period as may be required by applicable law, regulation, or institutional policy, whichever is longer. This retention obligation is consistent with the requirements of 21 C.F.R. Part 312, ICH E6(R2) Guideline for Good Clinical Practice, and any applicable state or institutional record retention requirements. During the retention period, Veridian shall ensure that such records are stored securely and made available for audit and inspection by Penterra, regulatory authorities, or their authorized representatives upon reasonable notice.

Section 3.3 — Data Access and Use by Veridian

Veridian and Site Personnel may access and use de-identified, aggregated Study Data solely for the following purposes:

(a) Academic publication, subject to the publication rights provisions set forth in Article 6 of this Agreement and Exhibit G of the MCTA, including compliance with all review and approval procedures specified therein; and

(b) Regulatory and institutional review board ("IRB") compliance obligations, including responding to audits, inspections, and inquiries from the FDA, the Office for Human Research Protections ("OHRP"), accrediting bodies, and institutional IRBs.

Veridian and Site Personnel shall not use Study Data, whether in identified, de-identified, or aggregated form, for any commercial purpose, including but not limited to licensing, sublicensing, product development, or revenue generation, without the prior written consent of Penterra. Any request for commercial use of Study Data shall be submitted to Penterra in writing and shall describe in reasonable detail the proposed use, the data to be accessed, and the commercial purpose. Penterra shall respond to any such request within thirty (30) calendar days.

ARTICLE 4 — OWNERSHIP OF INVENTIONS

Section 4.1 — Sole Inventions by Sponsor

Any Invention conceived or reduced to practice solely by employees, agents, or contractors of Penterra, including without limitation Meridian Contract Research Organization, Inc. personnel acting under that certain Master Services Agreement between Penterra and Meridian dated January 15, 2023, shall be the sole and exclusive property of Penterra (each, a "Sponsor Sole Invention"). Veridian and Site Personnel shall have no right, title, interest, license, or other claim in or to any Sponsor Sole Invention, except to the extent expressly set forth in this Agreement. Penterra shall have the unrestricted right to use, develop, manufacture, commercialize, license, sublicense, assign, and otherwise exploit Sponsor Sole Inventions without any obligation to account to Veridian or any Site Personnel.

Section 4.2 — Sole Inventions by Site Personnel

(a) Any Invention conceived or reduced to practice solely by Site Personnel, to the extent such Invention (i) does not incorporate, utilize, or derive from Sponsor IP, Study Data, or Confidential Information of Penterra, and (ii) relates solely to general research methodologies, clinical practices, patient care protocols, or institutional processes that are not specific to penterafenib (PPC-4871) or the Protocol, shall be the sole and exclusive property of Veridian or the applicable site institution whose personnel conceived or reduced such Invention to practice (each, a "Site Sole Invention"). Penterra shall have no right, title, interest, license, or other claim in or to any Site Sole Invention, except as expressly provided in Section 4.4 below.

(b) Notwithstanding Section 4.2(a), any Invention conceived or reduced to practice solely by Site Personnel that incorporates, utilizes, or is derived from Sponsor IP, Study Data, or Confidential Information of Penterra — including without limitation any Invention relating specifically to the mechanism of action, efficacy, safety, dosing, formulation, or clinical use of penterafenib — shall be the sole and exclusive property of Penterra. Veridian shall, and shall cause the applicable Site Personnel and site institutions to, promptly disclose any such Invention to Penterra and execute all documents, instruments, assignments, declarations, and other papers reasonably necessary to assign and transfer all right, title, and interest in and to such Invention to Penterra. Veridian shall bear responsibility for ensuring that its member institutions and Site Personnel comply with this obligation, including through the enforcement of institutional IP policies and the Individual Site Agreements executed under the MCTA.

Section 4.3 — Joint Inventions

Any Joint Invention shall be jointly owned by Penterra and Veridian (or the applicable site institution whose personnel participated in the inventive activity), with each Party's ownership interest determined in accordance with the principles of joint inventorship under applicable U.S. patent law, subject to the license grants and other provisions of this Article 4. Unless otherwise expressly provided in this Agreement, neither Party shall have any obligation to account to the other Party for any use or exploitation of a Joint Invention, except as specifically set forth in Sections 4.4 and 4.5 below. The Parties acknowledge and agree that the license grants set forth in Section 4.4 are intended to define and govern the Parties' respective rights to exploit Joint Inventions, notwithstanding any default rules of joint patent ownership under 35 U.S.C. § 262.

Section 4.4 — License to Joint Inventions

(a) Penterra License. Veridian and each applicable site institution hereby grant to Penterra an exclusive (even as to Veridian and the applicable site institution, except as set forth in Section 4.4(b)), worldwide, royalty-bearing (as set forth in Section 4.5), irrevocable, perpetual license, with the right to sublicense through multiple tiers, to use, develop, make, have made, manufacture, have manufactured, import, export, offer for sale, sell, distribute, market, promote, commercialize, and otherwise exploit any Joint Invention in the field of oncology and hepatology, including without limitation for the development and commercialization of penterafenib (PPC-4871), any salts, polymorphs, prodrugs, metabolites, analogues, or derivatives thereof, and any follow-on compounds, combination products, or companion diagnostics related thereto.

(b) Veridian License. Penterra hereby grants to Veridian and the applicable site institution a non-exclusive, non-transferable, royalty-free license to use any Joint Invention solely for internal, non-commercial academic research and educational purposes, including without limitation academic publications, conference presentations, training of medical students and residents, and grant applications to governmental and nonprofit funding agencies. This license does not include any right to sublicense for commercial purposes, and Veridian and the applicable site institution shall not use any Joint Invention for commercial product development, licensing to third parties for commercial purposes, or revenue generation without the prior written consent of Penterra.

Section 4.5 — Royalty on Joint Inventions

(a) Royalty Rate. In consideration of the exclusive license granted to Penterra under Section 4.4(a), Penterra shall pay to Veridian (or the applicable site institution, as designated by Veridian in writing) a royalty equal to a percentage of Net Sales of any product that is covered by a valid claim of an issued and unexpired patent (that has not been held invalid or unenforceable by a court of competent jurisdiction from which no appeal can be or is taken) issuing from a Joint Invention. The applicable royalty rate shall be as set forth in a royalty schedule to be negotiated in good faith by the Parties within ninety (90) days following the identification of any Joint Invention and shall be memorialized in a written amendment to this Agreement. If the Parties are unable to agree on a royalty rate within such ninety (90) day period, the royalty rate shall be determined by the independent patent attorney designated under Section 4.6(c), taking into account the relative inventive contributions of the Parties, prevailing industry royalty rates for comparable transactions in the oncology field, and the commercial value of the Joint Invention. Royalties shall be payable quarterly, within sixty (60) days following the end of each calendar quarter in which Net Sales are received.

(b) Duration. Royalty obligations under this Section 4.5 shall survive for the life of the applicable patent covering the Joint Invention in each jurisdiction, and shall expire on a country-by-country basis upon the later of (i) the expiration of the last-to-expire valid claim of such patent in the applicable country, or (ii) the expiration of any regulatory exclusivity period applicable to the covered product in such country.

(c) Royalty Stacking. In the event that Penterra is obligated to pay royalties to two or more parties (including Veridian and any third party) for the same product based on overlapping patent claims, the total royalty obligations payable by Penterra with respect to such product may be subject to a cap to be negotiated in good faith by the Parties, and the royalties payable to Veridian and any other co-owners shall be allocated proportionally based on the relative strength and scope of the applicable patent claims.

(d) Accounting and Audit Rights. Penterra shall maintain complete and accurate books and records reflecting Net Sales of products covered by Joint Invention patents, in sufficient detail to enable the calculation and verification of royalties payable hereunder. Such books and records shall be maintained for a period of not less than five (5) years following the calendar year to which they relate. Veridian shall have the right, no more than once per calendar year, to audit such books and records upon not less than thirty (30) days' prior written notice, using an independent certified public accountant reasonably acceptable to both Parties. Such audit shall be conducted during normal business hours at the location where such records are maintained. The cost of the audit shall be borne by Veridian, unless the audit reveals an underpayment of royalties of five percent (5%) or more for any audited period, in which case Penterra shall bear the reasonable cost of the audit and shall promptly remit any underpayment, together with interest at the rate of one and one-half percent (1.5%) per month from the date such payment was originally due.

Section 4.6 — Inventorship Determination

(a) Inventorship of any Invention arising under the Protocol shall be determined in accordance with applicable U.S. patent law, including 35 U.S.C. §§ 101–103 and 116, and the body of case law interpreting the standard for inventive contribution under U.S. patent law.

(b) In the event of a dispute between the Parties regarding the inventorship or classification of an Invention as a Sponsor Sole Invention, a Site Sole Invention, or a Joint Invention, the Parties shall first attempt to resolve such dispute through good-faith negotiation between their designated representatives — Rebecca Liang, Esq., Associate General Counsel, Clinical Affairs, for Penterra, and Gregory Callahan, Esq., Vice President, Legal & Compliance, for Veridian — for a period of thirty (30) days following written notice of the dispute from either Party.

(c) If the dispute is not resolved within the thirty (30) day negotiation period described in Section 4.6(b), the dispute shall be submitted to an independent patent attorney mutually agreed upon by the Parties, who shall have at least fifteen (15) years of experience in pharmaceutical and biotechnology patent prosecution and who shall not have any existing relationship with either Party. The independent patent attorney shall review all relevant evidence, including laboratory notebooks, invention disclosure forms, correspondence, and witness statements, and shall render a written determination of inventorship within sixty (60) days of his or her engagement. Such determination shall be final and binding upon the Parties. The costs and fees of the independent patent attorney shall be shared equally by the Parties.

ARTICLE 5 — PATENT PROSECUTION AND MAINTENANCE

Section 5.1 — Sponsor Sole Inventions

Penterra shall have the sole and exclusive right and responsibility, at its own expense, to prepare, file, prosecute, maintain, defend, and enforce Patent Rights covering Sponsor Sole Inventions in all jurisdictions worldwide, using patent counsel of its own selection. Penterra shall have no obligation to consult with Veridian or to provide Veridian with any information regarding the prosecution or maintenance of patents covering Sponsor Sole Inventions.

Section 5.2 — Site Sole Inventions

Veridian (or the applicable site institution) shall have the sole and exclusive right and responsibility, at its own expense, to prepare, file, prosecute, maintain, defend, and enforce Patent Rights covering Site Sole Inventions in all jurisdictions worldwide, using patent counsel of its own selection. Veridian shall provide Penterra with prompt written notice of any patent application filed covering a Site Sole Invention, to the extent such Site Sole Invention relates to the therapeutic area addressed by the Protocol (i.e., oncology, hepatology, or hepatocellular carcinoma), together with a copy of the published application or, if not yet published, a summary of the claimed subject matter. This notice obligation is intended solely to ensure that there is no inadvertent encroachment upon Sponsor IP and shall not be construed as granting Penterra any rights in Site Sole Inventions.

Section 5.3 — Joint Inventions — Patent Prosecution

(a) Penterra shall have the first right, but not the obligation, to prepare, file, prosecute, and maintain Patent Rights covering Joint Inventions in all jurisdictions worldwide, at Penterra's sole cost and expense.

(b) Penterra shall engage outside patent counsel reasonably acceptable to both Parties for the prosecution of Joint Invention patents. Penterra shall consult with Veridian's designated patent representative regarding the selection of outside counsel and shall give reasonable consideration to any objections raised by Veridian, provided that Penterra's determination shall be final in the event the Parties are unable to agree.

(c) Penterra shall keep Veridian reasonably informed of the status of all patent applications and issued patents covering Joint Inventions, including by providing Veridian with copies of all substantive patent office communications (including office actions, examiner interviews, and restriction requirements), draft patent applications, proposed amendments, and proposed responses to office actions at least fifteen (15) business days before the applicable filing deadline. Veridian shall have the right to review and comment upon all such materials, and Penterra shall give reasonable consideration to Veridian's comments. The Parties acknowledge that the final decision regarding prosecution strategy, claim scope, and responses to patent office communications shall rest with Penterra, subject to its obligation to act in good faith and to protect the legitimate interests of both co-owners.

(d) If Penterra elects not to file, prosecute, or maintain a patent application or patent covering a Joint Invention in any jurisdiction, Penterra shall provide Veridian with at least sixty (60) days' prior written notice of such election (or, if sixty (60) days' notice is not practicable due to an impending statutory deadline, as much notice as is reasonably practicable under the circumstances). Upon receipt of such notice, Veridian (or the applicable site institution) shall have the right, but not the obligation, to assume responsibility for the preparation, filing, prosecution, and maintenance of the applicable patent application or patent in such jurisdiction, at Veridian's sole cost and expense. In the event Veridian assumes prosecution, Penterra shall retain its co-ownership interest in the Joint Invention and any resulting patent, subject to the license grants set forth in Section 4.4, and Penterra shall reasonably cooperate with Veridian's prosecution efforts, including by executing any assignments, declarations, or powers of attorney necessary for Veridian to prosecute and maintain the applicable patent application or patent.

Section 5.4 — Joint Inventions — Enforcement

(a) In the event that either Party becomes aware of any actual or threatened infringement by a third party of any patent covering a Joint Invention, such Party shall promptly notify the other Party in writing, providing all available details regarding the nature and scope of the infringement.

(b) Penterra shall have the first right, but not the obligation, to enforce any patent covering a Joint Invention against any third-party infringer, at Penterra's sole cost and expense. Penterra shall have the right to select counsel and to control the conduct of any enforcement proceedings, including settlement negotiations, provided that Penterra shall not settle any enforcement action in a manner that adversely affects Veridian's co-ownership interest or imposes any obligation on Veridian without Veridian's prior written consent.

(c) If Penterra does not initiate enforcement proceedings within one hundred twenty (120) days of becoming aware of the infringement (or within such shorter period as may be necessary to preserve any legal rights or remedies), Veridian shall have the right to initiate enforcement proceedings at its own cost and expense, with Penterra's reasonable cooperation, including joining as a necessary party if required by applicable law or court rules.

(d) Any monetary recovery obtained from enforcement proceedings (whether by judgment, settlement, or otherwise) shall be applied first to reimburse the enforcing Party for all costs, expenses, and attorneys' fees incurred in connection with such enforcement. Any remaining recovery shall be shared by the Parties in proportion to their respective inventive contributions to the Joint Invention, or as otherwise agreed in writing by the Parties.

Section 5.5 — Cooperation

Each Party shall reasonably cooperate with the other Party in connection with the preparation, filing, prosecution, maintenance, defense, and enforcement of Patent Rights under this Article 5, including by executing all necessary and appropriate assignments, inventor declarations, powers of attorney, and other instruments, and by making its employees, agents, and Site Personnel available for consultations, depositions, and testimony as reasonably requested. Without limiting the foregoing, Site Personnel, including Dr. Catherine Aldridge, Global Principal Investigator, and Dr. Howard Matsuoka, Co-Principal Investigator, shall execute inventor declarations and assignments as necessary and consistent with this Article 5 and the institutional IP policies applicable to their respective institutions. The cooperating Party's reasonable out-of-pocket expenses incurred in connection with such cooperation shall be reimbursed by the requesting Party.

ARTICLE 6 — PUBLICATION RIGHTS

Section 6.1 — Right to Publish

Investigators and Site Personnel shall have the right to publish or present the results of the CLARION trial in peer-reviewed journals and at scientific and medical conferences, subject to the review and approval procedures set forth in this Article 6 and consistent with the provisions of Exhibit G (Intellectual Property and Publication Rights) of the MCTA. The Parties acknowledge the importance of the timely dissemination of clinical trial results for the advancement of medical science and the benefit of patients, and agree that the review procedures described herein are intended to balance the interests of academic publication with the protection of patentable subject matter and Confidential Information.

Section 6.2 — Review Period

Prior to any submission for publication in any journal, presentation at any scientific or medical conference, posting on any preprint server, or other public disclosure, the publishing investigator shall submit the complete proposed manuscript, abstract, poster, slide presentation, or other material (each, a "Proposed Publication") to Penterra for review. Penterra shall have a period of sixty (60) calendar days from the date of receipt of the Proposed Publication (the "Initial Review Period") to review the Proposed Publication for: (a) the inclusion of any Confidential Information of Penterra, and (b) the disclosure of any patentable subject matter.

(i) If Penterra identifies Confidential Information of Penterra contained in the Proposed Publication, Penterra shall notify the publishing investigator in writing, specifying the Confidential Information to be removed or modified. The publishing investigator shall remove or modify such Confidential Information prior to submission of the Proposed Publication.

(ii) If Penterra identifies patentable subject matter in the Proposed Publication, Penterra may request in writing a delay of publication for up to an additional ninety (90) calendar days beyond the expiration of the Initial Review Period (the "Patent Delay Period") to allow for the preparation and filing of one or more patent applications covering such patentable subject matter. During the Patent Delay Period, Penterra shall diligently pursue the preparation and filing of such patent applications.

Section 6.3 — No Unreasonable Withholding

Penterra shall not unreasonably withhold, condition, or delay its consent to the publication or presentation of results of the CLARION trial. In no event shall the total period of delay from the date of Penterra's initial receipt of a Proposed Publication to the date on which the publishing investigator is permitted to submit the Proposed Publication for publication exceed one hundred fifty (150) calendar days (comprising the sixty (60) day Initial Review Period and the ninety (90) day Patent Delay Period). If Penterra fails to provide written notice of any objection or request for delay within the Initial Review Period, consent to publication shall be deemed granted.

Section 6.4 — Investigator Grants and Publication Support

Investigator grants totaling One Million Five Hundred Thousand Dollars ($1,500,000) have been designated under the MCTA for academic publication support. Such grants shall be disbursed to the applicable investigators and site institutions upon acceptance of manuscripts for publication in peer-reviewed journals, in accordance with the schedule and procedures set forth in Exhibit B (Budget and Payment Schedule) of the MCTA. Disbursement of publication support grants shall not be contingent upon Penterra's approval of the content of any accepted manuscript, provided that the manuscript has undergone the review process described in this Article 6.

ARTICLE 7 — CONFIDENTIALITY

Section 7.1 — Incorporation of MCTA Confidentiality Provisions

The confidentiality obligations set forth in the MCTA and Exhibit F thereto (Confidentiality and Data Protection Provisions) are hereby incorporated into this Agreement by reference and shall apply with full force and effect to all information disclosed by either Party to the other Party under or in connection with this Side Letter. Without limiting the generality of the foregoing, each Party shall treat as confidential all Inventions, patent applications, patent prosecution materials, invention disclosures, royalty information, and other proprietary information received from the other Party in connection with this Agreement, and shall not disclose such information to any third party except as expressly permitted by this Agreement, the MCTA, or Exhibit F thereto. The confidentiality obligations set forth in this Article 7 shall remain in effect for a period of ten (10) years from the date of disclosure of the applicable Confidential Information, regardless of the expiration or termination of this Agreement or the MCTA.

Section 7.2 — Patent Applications

Notwithstanding the foregoing confidentiality obligations, the filing and prosecution of patent applications in accordance with Article 5 of this Agreement shall not constitute a breach of the confidentiality obligations set forth herein or in the MCTA, provided that the filing Party uses commercially reasonable efforts to limit the disclosure of Confidential Information in patent applications and related filings to what is necessary and appropriate for patent prosecution purposes. Each Party shall, to the extent practicable, provide the other Party with advance notice of any disclosure of the other Party's Confidential Information in a patent filing and shall reasonably consider the other Party's comments regarding the scope of such disclosure.

ARTICLE 8 — REPRESENTATIONS AND WARRANTIES

Section 8.1 — Penterra Representations

Penterra represents and warrants to Veridian as of the Effective Date as follows:

(a) Penterra has the full right, power, and authority to enter into this Side Letter, to perform its obligations hereunder, and to grant the rights and licenses granted herein, and the execution, delivery, and performance of this Side Letter have been duly authorized by all necessary corporate action.

(b) To Penterra's knowledge, as of the Effective Date, the Investigational Product and related Sponsor IP do not infringe any issued patent or misappropriate any trade secret of any third party, and there is no pending or threatened claim, action, or proceeding alleging such infringement or misappropriation.

(c) Penterra has not granted any rights, licenses, or interests in Sponsor IP to any third party that are inconsistent with the rights and obligations set forth in this Side Letter, and the execution and performance of this Side Letter do not conflict with or constitute a breach of any agreement, obligation, or commitment to which Penterra is a party.

Section 8.2 — Veridian Representations

Veridian represents and warrants to Penterra as of the Effective Date as follows:

(a) Veridian has the full right, power, and authority to enter into this Side Letter, to perform its obligations hereunder, and to bind its member institutions with respect to intellectual property matters arising under the MCTA and this Side Letter, and the execution, delivery, and performance of this Side Letter have been duly authorized by all necessary corporate action and, to the extent required, by the governing bodies of the applicable member institutions.

(b) Veridian has obtained, or prior to the commencement of Protocol activities at each participating site will obtain, appropriate intellectual property assignment or license agreements from Site Personnel sufficient to enable Veridian to comply with its obligations under this Side Letter, including without limitation the assignment obligations set forth in Section 4.2(b) and the cooperation obligations set forth in Section 5.5.

(c) Site Personnel are subject to institutional intellectual property policies that require the assignment or disclosure of Inventions conceived or reduced to practice in the course of their employment or engagement, and such policies are enforceable under applicable law and the terms of employment or engagement of such Site Personnel.

Section 8.3 — No Warranty of Patentability

Neither Party makes any representation or warranty that any Invention will be patentable or that any patent application filed hereunder will result in the issuance of a patent. Neither Party shall be liable to the other Party for the failure of any patent application to issue as a patent or for the invalidity or unenforceability of any patent.

ARTICLE 9 — TERM AND TERMINATION

Section 9.1 — Term

This Side Letter shall be effective as of the Effective Date and shall continue in full force and effect for the duration of the MCTA. Thereafter, this Side Letter shall continue in effect with respect to any provisions that by their nature are intended to survive the termination or expiration of the MCTA, including without limitation the following: ownership of Inventions (Article 4), license grants (Section 2.2, to the extent of any continuing obligations, and Sections 4.4(a) and 4.4(b)), royalty obligations (Section 4.5), patent prosecution and enforcement rights and obligations (Article 5), confidentiality obligations (Article 7), publication rights (Article 6), representations and warranties (Article 8), dispute resolution (Article 10), and general provisions (Article 11).

Section 9.2 — Effect of MCTA Termination

Termination or expiration of the MCTA, whether by its terms, by mutual agreement, or by the exercise of a termination right thereunder, shall not affect:

(a) The Parties' respective ownership interests in Inventions, including Sponsor Sole Inventions, Site Sole Inventions, and Joint Inventions, as determined in accordance with Article 4;

(b) Penterra's exclusive ownership of Study Data, as set forth in Section 3.1;

(c) The license grants for Joint Inventions set forth in Sections 4.4(a) and 4.4(b), which shall remain in full force and effect;

(d) Penterra's royalty obligations under Section 4.5, which shall continue in accordance with their terms;

(e) The Parties' patent prosecution and enforcement rights and obligations under Article 5, which shall survive in accordance with their terms; and

(f) The confidentiality obligations under Article 7, which shall survive for the full ten (10) year period specified therein.

The one hundred twenty (120) day wind-down period set forth in the MCTA's termination provisions shall apply to any ongoing inventive activities under the Protocol, including the completion of experiments, analyses, or other work necessary to properly characterize and document any Invention in progress at the time of termination.

ARTICLE 10 — DISPUTE RESOLUTION

Section 10.1 — Governing Law

This Side Letter shall be governed by and construed in accordance with the laws of the State of New York, without giving effect to any choice-of-law or conflicts-of-law principles that would result in the application of the laws of any other jurisdiction, consistent with the governing law provision of the MCTA.

Section 10.2 — Dispute Resolution Procedures

Any dispute, controversy, or claim arising out of or relating to this Side Letter, or the breach, termination, or validity thereof (other than disputes regarding inventorship or classification of Inventions, which shall be resolved in accordance with Section 4.6), shall be resolved in accordance with the following escalation procedures, consistent with the dispute resolution provisions of the MCTA:

(a) Negotiation. The Parties shall first attempt to resolve the dispute through good-faith negotiation between their designated representatives — Rebecca Liang, Esq., for Penterra, and Gregory Callahan, Esq., for Veridian — for a period of thirty (30) days following written notice from either Party describing the nature of the dispute in reasonable detail.

(b) Mediation. If the dispute is not resolved through negotiation within the thirty (30) day period described in Section 10.2(a), either Party may initiate mediation by delivering written notice to the other Party. The mediation shall be conducted under the Commercial Mediation Rules of the American Arbitration Association ("AAA") then in effect, before a single mediator mutually selected by the Parties. The mediation shall be held in New York, New York, and shall be completed within sixty (60) days of the initiation of the mediation, unless the Parties mutually agree to extend such period. The costs of the mediator shall be shared equally by the Parties.

(c) Binding Arbitration. If the dispute is not resolved through mediation within the sixty (60) day period described in Section 10.2(b), either Party may submit the dispute to final and binding arbitration administered by the AAA in accordance with its Commercial Arbitration Rules then in effect. The arbitration shall be conducted in New York, New York, before a panel of three (3) arbitrators, one selected by each Party and the third selected by the two Party-appointed arbitrators. Each arbitrator shall have significant experience in pharmaceutical industry transactions and intellectual property law. The arbitrators shall render a reasoned written decision within ninety (90) days of the close of the arbitration hearing. The decision of the arbitrators shall be final, binding, and non-appealable (except as provided by applicable law), and judgment upon the award may be entered in any court of competent jurisdiction.

For the avoidance of doubt, disputes regarding inventorship or classification of Inventions as Sponsor Sole Inventions, Site Sole Inventions, or Joint Inventions shall be resolved exclusively through the procedures set forth in Section 4.6 of this Agreement and shall not be subject to the mediation or arbitration procedures described in this Section 10.2.

Section 10.3 — Injunctive Relief

Notwithstanding the dispute resolution procedures set forth in Section 10.2, either Party may seek temporary, preliminary, or permanent injunctive relief or other equitable remedies in the state and federal courts located in New York County, New York, to prevent or restrain any actual or threatened unauthorized use, disclosure, or misappropriation of intellectual property, Inventions, Study Data, or Confidential Information, without the necessity of proving actual damages or posting a bond or other security. Each Party consents to the personal jurisdiction and venue of such courts for purposes of any action seeking injunctive or equitable relief under this Section 10.3.

ARTICLE 11 — GENERAL PROVISIONS

Section 11.1 — Entire Agreement; Relationship to MCTA

This Side Letter, together with the MCTA (including all exhibits and schedules thereto, and in particular Exhibit G — Intellectual Property and Publication Rights), constitutes the entire agreement between the Parties with respect to the subject matter hereof and supersedes all prior and contemporaneous agreements, understandings, negotiations, and discussions, whether oral or written, between the Parties with respect to such subject matter. In the event of any conflict or inconsistency between the provisions of this Side Letter and the provisions of the MCTA (including Exhibit G) with respect to intellectual property matters, the provisions of this Side Letter shall control and govern.

Section 11.2 — Amendments

No amendment, modification, supplement, or waiver of any provision of this Side Letter shall be effective unless set forth in a written instrument executed by duly authorized representatives of both Parties. Any such amendment shall expressly reference this Side Letter and the specific provisions being amended.

Section 11.3 — Assignment

Neither Party may assign, transfer, or delegate this Side Letter or any of its rights, obligations, or interests hereunder without the prior written consent of the other Party, which consent shall not be unreasonably withheld, conditioned, or delayed; provided, however, that either Party may assign this Side Letter without the other Party's consent in connection with a merger, consolidation, reorganization, or sale or transfer of all or substantially all of such Party's assets or business to which this Side Letter relates, provided that the assignee expressly assumes in writing all of the assigning Party's obligations under this Side Letter. Any attempted assignment in violation of this Section 11.3 shall be null and void. This Side Letter shall be binding upon and inure to the benefit of the Parties and their respective permitted successors and assigns.

Section 11.4 — Notices

All notices, requests, demands, consents, and other communications required or permitted under this Side Letter shall be in writing and shall be delivered in accordance with the notice provisions set forth in the MCTA. For purposes of this Side Letter, the designated notice recipients are as follows:

If to Penterra:

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

With a copy to:

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

If to Veridian:

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

Section 11.5 — Severability

If any provision of this Side Letter is held to be invalid, illegal, or unenforceable by a court of competent jurisdiction or an arbitral tribunal, such invalidity, illegality, or unenforceability shall not affect the validity, legality, or enforceability of any other provision of this Side Letter, and the remaining provisions shall continue in full force and effect. In the event of such a determination, the Parties shall negotiate in good faith to replace the invalid, illegal, or unenforceable provision with a valid, legal, and enforceable provision that, to the maximum extent practicable, achieves the economic, business, and other purposes of the original provision.

Section 11.6 — Waiver

No failure or delay by either Party in exercising any right, power, or remedy under this Side Letter shall operate as a waiver thereof, nor shall any single or partial exercise of any right, power, or remedy preclude any other or further exercise thereof or the exercise of any other right, power, or remedy. No waiver of any breach or default under this Side Letter shall constitute a waiver of any subsequent or prior breach or default, whether of the same or a different provision. All waivers must be in writing and signed by the waiving Party to be effective.

Section 11.7 — Counterparts

This Side Letter may be executed in two or more counterparts, each of which shall be deemed an original and all of which together shall constitute one and the same instrument. Execution and delivery of this Side Letter by facsimile, electronic mail (in PDF or similar format), or other electronic means shall have the same legal force and effect as execution and delivery of an original counterpart.

Section 11.8 — Third-Party Beneficiaries

Participating site institutions that are members of the Veridian Health Research Network and that execute Individual Site Agreements (joinders) under the MCTA shall be express third-party beneficiaries of this Side Letter to the extent of their inventive contributions to Joint Inventions and their rights with respect to Site Sole Inventions and publication rights as described herein. Such third-party beneficiary rights shall be enforceable by the applicable site institution directly, subject to the dispute resolution procedures of Article 10. Except as expressly set forth in this Section 11.8, this Side Letter is not intended to, and shall not, confer any rights or remedies upon any person or entity other than the Parties hereto and their permitted successors and assigns.

[Remainder of page intentionally left blank. Signature page follows.]

SIGNATURE PAGE TO INTELLECTUAL PROPERTY SIDE LETTER

IN WITNESS WHEREOF, the Parties have caused this intellectual Property Side Letter to be executed by their duly authorized representatives as of the date first written above.

PENTERRA PHARMACEUTICALS CORP.

By: ________

Name: Nathaniel Briggs, Esq.

Title: Vice President & General Counsel

Date: June 28, 2023

VERIDIAN HEALTH RESEARCH NETWORK, INC.

By: ________

Name: Dr. Franklin Osei, M.D., Ph.D.

Title: President & Chief Executive Officer

Date: June 28, 2023

ACKNOWLEDGED AND AGREED (Lead Site):

GRAYSTONE UNIVERSITY MEDICAL CENTER

By: ________

Name: Dr. William Corwin, M.D.

Title: President

Date: June 28, 2023

INTELLECTUAL PROPERTY SIDE LETTER
Execution Version
June 28, 2023
This intellectual Property Side Letter (this "Agreement" or "Side Letter") is entered into as of June 28, 2023 (the "Effective Date"), concurrently with and supplemental to that certain Master Clinical Trial Agreement dated June 28, 2023 (the "MCTA"), by and between the parties identified herein.
Protocol Reference: Protocol PPC-4871-III (CLARION — Clinical Assessment of Response with Longitudinal Investigation in ONcology)
ClinicalTrials.gov Identifier: NCT05928174
IND Number: IND 157823
PARTIES
PENTERRA PHARMACEUTICALS CORP. ("Sponsor" or "Penterra"), a corporation organized and existing under the laws of the State of Delaware, with its principal offices located at 200 Biopharma Boulevard, Suite 1400, Princeton, New Jersey 08540;
and
VERIDIAN HEALTH RESEARCH NETWORK, INC. ("Site Network" or "Veridian"), a not-for-profit corporation organized and existing under the laws of the State of Delaware and recognized as tax-exempt under Section 501(c)(3) of the Internal Revenue Code of 1986, as amended, with its principal offices located at 750 Research Parkway, 8th Floor, Philadelphia, Pennsylvania 19104.
Penterra and Veridian are referred to herein collectively as the "Parties" and each individually as a "Party."
RECITALS
WHEREAS, Sponsor and Site Network have entered into that certain Master Clinical Trial Agreement dated June 28, 2023 (the "MCTA"), governing the conduct of Protocol PPC-4871-III (CLARION), a Phase III, randomized, double-blind, placebo-controlled clinical trial of penterafenib (PPC-4871), an oral multi-kinase inhibitor, in subjects with advanced hepatocellular carcinoma ("HCC");
WHEREAS, the MCTA provides for the participation of thirty-eight (38) Veridian Network academic medical centers and affiliated research sites across fourteen (14) states, with a total deal value of Eighty Million Dollars ($80,000,000) covering site fees, per-patient payments, investigator grants, and operational costs over the projected forty-two (42) month enrollment period;
WHEREAS, the MCTA contemplates the execution of this intellectual Property Side Letter to address ownership, licensing, and prosecution of intellectual property and inventions arising in connection with the CLARION trial, as referenced in Section 12.4 of the MCTA and Exhibit G thereto;
WHEREAS, the Parties desire to set forth their respective rights and obligations with respect to pre-existing intellectual property, study data, inventions conceived or reduced to practice during the conduct of the trial, and patent prosecution procedures, in a comprehensive manner that supplements and, where applicable, supersedes the summary provisions contained in Exhibit G of the MCTA;
WHEREAS, this Side Letter is intended to be read and construed together with the MCTA, and in the event of any conflict between this Side Letter and the MCTA with respect to intellectual property matters, this Side Letter shall control; and
NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth herein and the obligations undertaken in the MCTA, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:
ARTICLE 1 — DEFINITIONS
Section 1.1 — Defined Terms
As used in this Agreement, the following terms shall have the meanings set forth below:
(a) "Agreement" means this intellectual Property Side Letter, including any amendments, modifications, or supplements hereto executed in writing by both Parties.
(b) "Background IP" or "Pre-Existing IP" means all intellectual property, including but not limited to patents, patent applications, trade secrets, know-how, copyrights, data, materials, compounds, formulations, software, databases, algorithms, and proprietary information, that is (i) owned or controlled by a Party as of the Effective Date, or (ii) developed independently by a Party outside the scope of the CLARION trial, whether before, during, or after the term of the MCTA, and without use of or reference to the other Party's Confidential Information, Study Data, or intellectual property. For the avoidance of doubt, Background IP includes all intellectual property that a Party can demonstrate, through contemporaneous written records, was in its possession or under its control prior to the Effective Date or was independently developed without reference to activities conducted under the Protocol.
(c) "Confidential Information" has the meaning ascribed to such term in the MCTA and Exhibit F thereto (Confidentiality and Data Protection Provisions), and shall be subject to a confidentiality term of ten (10) years from the date of disclosure.
(d) "Investigational Product" means penterafenib (PPC-4871), the oral multi-kinase inhibitor that is the investigational compound studied under the Protocol, including all formulations, dosage forms, and delivery mechanisms thereof.
(e) "Invention" means any discovery, improvement, process, method, composition of matter, article of manufacture, technique, device, algorithm, software, biological material, biomarker, assay, or know-how, whether or not patentable or copyrightable, that is conceived or first reduced to practice in connection with or arising out of activities conducted under the Protocol. The term Invention shall be broadly construed and shall include, without limitation, new uses of the Investigational Product, diagnostic methods, patient selection criteria, formulation improvements, and bioanalytical methodologies developed in the course of Protocol activities.
(f) "Joint Invention" means an Invention that is conceived or reduced to practice jointly by (i) personnel of Sponsor, including any contract research organization ("CRO") personnel, consultants, or agents acting on Sponsor's behalf, and (ii) personnel of Site Network, a participating site institution, or an investigator, where inventorship is determined in accordance with applicable U.S. patent law as set forth in Section 4.6 of this Agreement.
(g) "MCTA" means the Master Clinical Trial Agreement dated June 28, 2023, between Penterra and Veridian, including all exhibits, schedules, appendices, amendments, and Individual Site Agreements (joinders) executed thereunder.
(h) "Net Sales" means, for purposes of royalty calculations under Section 4.5, the gross revenues received by Penterra, its affiliates, and its sublicensees from sales of products incorporating or covered by a valid claim of a patent issuing from a Joint Invention, less the following customary deductions to the extent actually incurred and directly attributable to such sales: (i) trade, quantity, and cash discounts actually allowed; (ii) credits, allowances, and refunds for returns; (iii) governmental rebates and chargebacks, including without limitation Medicaid, Medicare, and Tricare rebates and chargebacks required by applicable law; (iv) distribution fees and commissions paid to independent third-party distributors; and (v) sales taxes, value-added taxes, excise taxes, import/export duties, and other governmental charges imposed on such sales (excluding income taxes). Net Sales shall be calculated in accordance with United States Generally Accepted Accounting Principles ("GAAP"), consistently applied.
(i) "Patent Rights" means all patents and patent applications worldwide, including without limitation provisional applications, utility applications, continuations, continuations-in-part (to the extent claiming subject matter disclosed in the parent application), divisionals, reissues, reexaminations, inter partes reviews, supplementary protection certificates, patent term extensions, and any foreign counterparts or equivalents of any of the foregoing.
(j) "Protocol" means Protocol PPC-4871-III (CLARION — Clinical Assessment of Response with Longitudinal Investigation in ONcology), as amended from time to time in accordance with applicable regulatory requirements and the terms of the MCTA.
(k) "Site Personnel" means investigators (including Global Principal Investigator Dr. Catherine Aldridge and Co-Principal Investigator Dr. Howard Matsuoka), sub-investigators, research coordinators, pharmacists, study nurses, data managers, and other staff employed by or affiliated with Veridian Network participating sites who perform activities under the Protocol. For the avoidance of doubt, Site Personnel includes all individuals listed in Form FDA 1572 (Statement of Investigator) and any amendments thereto submitted in connection with the Protocol.
(l) "Sponsor IP" means all intellectual property owned or controlled by Penterra, including without limitation all intellectual property relating to penterafenib (PPC-4871), the Protocol, Sponsor's proprietary formulations, manufacturing processes, analytical methods, regulatory filings (including IND 157823 and any supplements thereto), clinical study reports, and marketing applications, together with all trade secrets, know-how, and proprietary information embodied therein.
(m) "Study Data" has the meaning ascribed to such term in the MCTA, and includes all clinical trial data, case report forms (electronic and paper), source data verifications, electronic data capture records, biomarker data (including genomic, proteomic, and metabolomic data), pharmacokinetic and pharmacodynamic data, safety data (including adverse event reports, serious adverse event reports, and suspected unexpected serious adverse reaction reports), imaging data, patient-reported outcome data, quality-of-life assessments, and any analyses, compilations, or reports generated in connection with the Protocol.
Section 1.2 — Interpretation
Capitalized terms used but not otherwise defined in this Agreement shall have the meanings ascribed to such terms in the MCTA. References to Exhibits in this Agreement include, where applicable, cross-references to exhibits of the MCTA, including Exhibit G (Intellectual Property and Publication Rights) and Exhibit F (Confidentiality and Data Protection Provisions). Unless the context otherwise requires, (a) words importing the singular include the plural and vice versa, (b) references to "including" or "includes" shall mean "including without limitation" or "includes without limitation," (c) references to "herein," "hereof," "hereunder," and similar terms refer to this Agreement as a whole and not to any particular section or provision, and (d) references to any statute, regulation, or rule include all amendments, modifications, and replacements thereof and all rules and regulations promulgated thereunder.
ARTICLE 2 — OWNERSHIP OF PRE-EXISTING INTELLECTUAL PROPERTY
Section 2.1 — Retention of Pre-Existing IP
Each Party shall retain all right, title, and interest in and to its Pre-Existing IP. Nothing in this Side Letter, the MCTA, or any exhibit, schedule, or amendment thereto shall be construed as transferring, assigning, or conveying ownership of Pre-Existing IP from one Party to the other, whether by implication, estoppel, or otherwise. Without limiting the generality of the foregoing:
(a) Penterra retains all right, title, and interest in and to penterafenib (PPC-4871), including without limitation its chemical composition, molecular structure, polymorphic forms, salt forms, formulations, dosage forms, manufacturing processes, analytical reference standards, and all regulatory filings associated therewith, including IND 157823, any investigator's brochure, and all supplements, amendments, and correspondence with the United States Food and Drug Administration ("FDA") and foreign regulatory authorities.
(b) Veridian and its member institutions retain all right, title, and interest in and to their respective pre-existing research methodologies, institutional standard operating procedures, proprietary patient recruitment platforms, clinical database architectures, institutional biobanking protocols, educational curricula, and any other proprietary systems or processes that existed prior to the Effective Date or that were developed independently of the Protocol.
Section 2.2 — Limited License to Pre-Existing IP
Each Party hereby grants to the other Party a non-exclusive, non-transferable, royalty-free license to use the granting Party's Pre-Existing IP solely to the extent necessary for the performance of such other Party's obligations under the Protocol and the MCTA. This license is limited in scope to activities directly related to the conduct of the CLARION trial and does not extend to any use beyond such activities. The license granted under this Section 2.2 shall terminate automatically upon the expiration or termination of the MCTA, subject to the survival provisions set forth in the MCTA, including the one hundred twenty (120) day wind-down period for subject safety obligations. Neither Party shall have the right to sublicense the Pre-Existing IP of the other Party except to approved subcontractors listed in Exhibit K of the MCTA — namely, Meridian Contract Research Organization, Inc., Pinnacle Data Solutions, Inc., and Northbridge Bioanalytical Laboratories, Inc. — and only with the prior written consent of the granting Party, such consent not to be unreasonably withheld, conditioned, or delayed.
ARTICLE 3 — OWNERSHIP OF STUDY DATA
Section 3.1 — Exclusive Sponsor Ownership
Penterra shall retain exclusive ownership of all Study Data generated in connection with the CLARION trial, consistent with the terms of the MCTA and Exhibit G thereto. For the avoidance of doubt, Study Data includes, without limitation, all clinical trial data, electronic data capture records (maintained on the Pinnacle Data Solutions, Inc. platform), centralized laboratory results (generated by Northbridge Bioanalytical Laboratories, Inc.), safety data, pharmacovigilance reports, biostatistical analyses (managed by Meridian Contract Research Organization, Inc.), interim analyses, final clinical study reports, and any derivative data sets or compilations. All Study Data shall be deemed Confidential Information of Penterra and shall be treated in accordance with the confidentiality obligations set forth in Article 7 of this Agreement and Exhibit F of the MCTA.
Section 3.2 — Site Record Retention
Veridian and each participating site institution shall retain source documents and site-level records in accordance with the MCTA's record retention obligations for a minimum of fifteen (15) years after study completion (currently projected for August 2028) or for such longer period as may be required by applicable law, regulation, or institutional policy, whichever is longer. This retention obligation is consistent with the requirements of 21 C.F.R. Part 312, ICH E6(R2) Guideline for Good Clinical Practice, and any applicable state or institutional record retention requirements. During the retention period, Veridian shall ensure that such records are stored securely and made available for audit and inspection by Penterra, regulatory authorities, or their authorized representatives upon reasonable notice.
Section 3.3 — Data Access and Use by Veridian
Veridian and Site Personnel may access and use de-identified, aggregated Study Data solely for the following purposes:
(a) Academic publication, subject to the publication rights provisions set forth in Article 6 of this Agreement and Exhibit G of the MCTA, including compliance with all review and approval procedures specified therein; and
(b) Regulatory and institutional review board ("IRB") compliance obligations, including responding to audits, inspections, and inquiries from the FDA, the Office for Human Research Protections ("OHRP"), accrediting bodies, and institutional IRBs.
Veridian and Site Personnel shall not use Study Data, whether in identified, de-identified, or aggregated form, for any commercial purpose, including but not limited to licensing, sublicensing, product development, or revenue generation, without the prior written consent of Penterra. Any request for commercial use of Study Data shall be submitted to Penterra in writing and shall describe in reasonable detail the proposed use, the data to be accessed, and the commercial purpose. Penterra shall respond to any such request within thirty (30) calendar days.
ARTICLE 4 — OWNERSHIP OF INVENTIONS
Section 4.1 — Sole Inventions by Sponsor
Any Invention conceived or reduced to practice solely by employees, agents, or contractors of Penterra, including without limitation Meridian Contract Research Organization, Inc. personnel acting under that certain Master Services Agreement between Penterra and Meridian dated January 15, 2023, shall be the sole and exclusive property of Penterra (each, a "Sponsor Sole Invention"). Veridian and Site Personnel shall have no right, title, interest, license, or other claim in or to any Sponsor Sole Invention, except to the extent expressly set forth in this Agreement. Penterra shall have the unrestricted right to use, develop, manufacture, commercialize, license, sublicense, assign, and otherwise exploit Sponsor Sole Inventions without any obligation to account to Veridian or any Site Personnel.
Section 4.2 — Sole Inventions by Site Personnel
(a) Any Invention conceived or reduced to practice solely by Site Personnel, to the extent such Invention (i) does not incorporate, utilize, or derive from Sponsor IP, Study Data, or Confidential Information of Penterra, and (ii) relates solely to general research methodologies, clinical practices, patient care protocols, or institutional processes that are not specific to penterafenib (PPC-4871) or the Protocol, shall be the sole and exclusive property of Veridian or the applicable site institution whose personnel conceived or reduced such Invention to practice (each, a "Site Sole Invention"). Penterra shall have no right, title, interest, license, or other claim in or to any Site Sole Invention, except as expressly provided in Section 4.4 below.
(b) Notwithstanding Section 4.2(a), any Invention conceived or reduced to practice solely by Site Personnel that incorporates, utilizes, or is derived from Sponsor IP, Study Data, or Confidential Information of Penterra — including without limitation any Invention relating specifically to the mechanism of action, efficacy, safety, dosing, formulation, or clinical use of penterafenib — shall be the sole and exclusive property of Penterra. Veridian shall, and shall cause the applicable Site Personnel and site institutions to, promptly disclose any such Invention to Penterra and execute all documents, instruments, assignments, declarations, and other papers reasonably necessary to assign and transfer all right, title, and interest in and to such Invention to Penterra. Veridian shall bear responsibility for ensuring that its member institutions and Site Personnel comply with this obligation, including through the enforcement of institutional IP policies and the Individual Site Agreements executed under the MCTA.
Section 4.3 — Joint Inventions
Any Joint Invention shall be jointly owned by Penterra and Veridian (or the applicable site institution whose personnel participated in the inventive activity), with each Party's ownership interest determined in accordance with the principles of joint inventorship under applicable U.S. patent law, subject to the license grants and other provisions of this Article 4. Unless otherwise expressly provided in this Agreement, neither Party shall have any obligation to account to the other Party for any use or exploitation of a Joint Invention, except as specifically set forth in Sections 4.4 and 4.5 below. The Parties acknowledge and agree that the license grants set forth in Section 4.4 are intended to define and govern the Parties' respective rights to exploit Joint Inventions, notwithstanding any default rules of joint patent ownership under 35 U.S.C. § 262.
Section 4.4 — License to Joint Inventions
(a) Penterra License. Veridian and each applicable site institution hereby grant to Penterra an exclusive (even as to Veridian and the applicable site institution, except as set forth in Section 4.4(b)), worldwide, royalty-bearing (as set forth in Section 4.5), irrevocable, perpetual license, with the right to sublicense through multiple tiers, to use, develop, make, have made, manufacture, have manufactured, import, export, offer for sale, sell, distribute, market, promote, commercialize, and otherwise exploit any Joint Invention in the field of oncology and hepatology, including without limitation for the development and commercialization of penterafenib (PPC-4871), any salts, polymorphs, prodrugs, metabolites, analogues, or derivatives thereof, and any follow-on compounds, combination products, or companion diagnostics related thereto.
(b) Veridian License. Penterra hereby grants to Veridian and the applicable site institution a non-exclusive, non-transferable, royalty-free license to use any Joint Invention solely for internal, non-commercial academic research and educational purposes, including without limitation academic publications, conference presentations, training of medical students and residents, and grant applications to governmental and nonprofit funding agencies. This license does not include any right to sublicense for commercial purposes, and Veridian and the applicable site institution shall not use any Joint Invention for commercial product development, licensing to third parties for commercial purposes, or revenue generation without the prior written consent of Penterra.
Section 4.5 — Royalty on Joint Inventions
(a) Royalty Rate. In consideration of the exclusive license granted to Penterra under Section 4.4(a), Penterra shall pay to Veridian (or the applicable site institution, as designated by Veridian in writing) a royalty equal to a percentage of Net Sales of any product that is covered by a valid claim of an issued and unexpired patent (that has not been held invalid or unenforceable by a court of competent jurisdiction from which no appeal can be or is taken) issuing from a Joint Invention. The applicable royalty rate shall be as set forth in a royalty schedule to be negotiated in good faith by the Parties within ninety (90) days following the identification of any Joint Invention and shall be memorialized in a written amendment to this Agreement. If the Parties are unable to agree on a royalty rate within such ninety (90) day period, the royalty rate shall be determined by the independent patent attorney designated under Section 4.6(c), taking into account the relative inventive contributions of the Parties, prevailing industry royalty rates for comparable transactions in the oncology field, and the commercial value of the Joint Invention. Royalties shall be payable quarterly, within sixty (60) days following the end of each calendar quarter in which Net Sales are received.
(b) Duration. Royalty obligations under this Section 4.5 shall survive for the life of the applicable patent covering the Joint Invention in each jurisdiction, and shall expire on a country-by-country basis upon the later of (i) the expiration of the last-to-expire valid claim of such patent in the applicable country, or (ii) the expiration of any regulatory exclusivity period applicable to the covered product in such country.
(c) Royalty Stacking. In the event that Penterra is obligated to pay royalties to two or more parties (including Veridian and any third party) for the same product based on overlapping patent claims, the total royalty obligations payable by Penterra with respect to such product may be subject to a cap to be negotiated in good faith by the Parties, and the royalties payable to Veridian and any other co-owners shall be allocated proportionally based on the relative strength and scope of the applicable patent claims.
(d) Accounting and Audit Rights. Penterra shall maintain complete and accurate books and records reflecting Net Sales of products covered by Joint Invention patents, in sufficient detail to enable the calculation and verification of royalties payable hereunder. Such books and records shall be maintained for a period of not less than five (5) years following the calendar year to which they relate. Veridian shall have the right, no more than once per calendar year, to audit such books and records upon not less than thirty (30) days' prior written notice, using an independent certified public accountant reasonably acceptable to both Parties. Such audit shall be conducted during normal business hours at the location where such records are maintained. The cost of the audit shall be borne by Veridian, unless the audit reveals an underpayment of royalties of five percent (5%) or more for any audited period, in which case Penterra shall bear the reasonable cost of the audit and shall promptly remit any underpayment, together with interest at the rate of one and one-half percent (1.5%) per month from the date such payment was originally due.
Section 4.6 — Inventorship Determination
(a) Inventorship of any Invention arising under the Protocol shall be determined in accordance with applicable U.S. patent law, including 35 U.S.C. §§ 101–103 and 116, and the body of case law interpreting the standard for inventive contribution under U.S. patent law.
(b) In the event of a dispute between the Parties regarding the inventorship or classification of an Invention as a Sponsor Sole Invention, a Site Sole Invention, or a Joint Invention, the Parties shall first attempt to resolve such dispute through good-faith negotiation between their designated representatives — Rebecca Liang, Esq., Associate General Counsel, Clinical Affairs, for Penterra, and Gregory Callahan, Esq., Vice President, Legal & Compliance, for Veridian — for a period of thirty (30) days following written notice of the dispute from either Party.
(c) If the dispute is not resolved within the thirty (30) day negotiation period described in Section 4.6(b), the dispute shall be submitted to an independent patent attorney mutually agreed upon by the Parties, who shall have at least fifteen (15) years of experience in pharmaceutical and biotechnology patent prosecution and who shall not have any existing relationship with either Party. The independent patent attorney shall review all relevant evidence, including laboratory notebooks, invention disclosure forms, correspondence, and witness statements, and shall render a written determination of inventorship within sixty (60) days of his or her engagement. Such determination shall be final and binding upon the Parties. The costs and fees of the independent patent attorney shall be shared equally by the Parties.
ARTICLE 5 — PATENT PROSECUTION AND MAINTENANCE
Section 5.1 — Sponsor Sole Inventions
Penterra shall have the sole and exclusive right and responsibility, at its own expense, to prepare, file, prosecute, maintain, defend, and enforce Patent Rights covering Sponsor Sole Inventions in all jurisdictions worldwide, using patent counsel of its own selection. Penterra shall have no obligation to consult with Veridian or to provide Veridian with any information regarding the prosecution or maintenance of patents covering Sponsor Sole Inventions.
Section 5.2 — Site Sole Inventions
Veridian (or the applicable site institution) shall have the sole and exclusive right and responsibility, at its own expense, to prepare, file, prosecute, maintain, defend, and enforce Patent Rights covering Site Sole Inventions in all jurisdictions worldwide, using patent counsel of its own selection. Veridian shall provide Penterra with prompt written notice of any patent application filed covering a Site Sole Invention, to the extent such Site Sole Invention relates to the therapeutic area addressed by the Protocol (i.e., oncology, hepatology, or hepatocellular carcinoma), together with a copy of the published application or, if not yet published, a summary of the claimed subject matter. This notice obligation is intended solely to ensure that there is no inadvertent encroachment upon Sponsor IP and shall not be construed as granting Penterra any rights in Site Sole Inventions.
Section 5.3 — Joint Inventions — Patent Prosecution
(a) Penterra shall have the first right, but not the obligation, to prepare, file, prosecute, and maintain Patent Rights covering Joint Inventions in all jurisdictions worldwide, at Penterra's sole cost and expense.
(b) Penterra shall engage outside patent counsel reasonably acceptable to both Parties for the prosecution of Joint Invention patents. Penterra shall consult with Veridian's designated patent representative regarding the selection of outside counsel and shall give reasonable consideration to any objections raised by Veridian, provided that Penterra's determination shall be final in the event the Parties are unable to agree.
(c) Penterra shall keep Veridian reasonably informed of the status of all patent applications and issued patents covering Joint Inventions, including by providing Veridian with copies of all substantive patent office communications (including office actions, examiner interviews, and restriction requirements), draft patent applications, proposed amendments, and proposed responses to office actions at least fifteen (15) business days before the applicable filing deadline. Veridian shall have the right to review and comment upon all such materials, and Penterra shall give reasonable consideration to Veridian's comments. The Parties acknowledge that the final decision regarding prosecution strategy, claim scope, and responses to patent office communications shall rest with Penterra, subject to its obligation to act in good faith and to protect the legitimate interests of both co-owners.
(d) If Penterra elects not to file, prosecute, or maintain a patent application or patent covering a Joint Invention in any jurisdiction, Penterra shall provide Veridian with at least sixty (60) days' prior written notice of such election (or, if sixty (60) days' notice is not practicable due to an impending statutory deadline, as much notice as is reasonably practicable under the circumstances). Upon receipt of such notice, Veridian (or the applicable site institution) shall have the right, but not the obligation, to assume responsibility for the preparation, filing, prosecution, and maintenance of the applicable patent application or patent in such jurisdiction, at Veridian's sole cost and expense. In the event Veridian assumes prosecution, Penterra shall retain its co-ownership interest in the Joint Invention and any resulting patent, subject to the license grants set forth in Section 4.4, and Penterra shall reasonably cooperate with Veridian's prosecution efforts, including by executing any assignments, declarations, or powers of attorney necessary for Veridian to prosecute and maintain the applicable patent application or patent.
Section 5.4 — Joint Inventions — Enforcement
(a) In the event that either Party becomes aware of any actual or threatened infringement by a third party of any patent covering a Joint Invention, such Party shall promptly notify the other Party in writing, providing all available details regarding the nature and scope of the infringement.
(b) Penterra shall have the first right, but not the obligation, to enforce any patent covering a Joint Invention against any third-party infringer, at Penterra's sole cost and expense. Penterra shall have the right to select counsel and to control the conduct of any enforcement proceedings, including settlement negotiations, provided that Penterra shall not settle any enforcement action in a manner that adversely affects Veridian's co-ownership interest or imposes any obligation on Veridian without Veridian's prior written consent.
(c) If Penterra does not initiate enforcement proceedings within one hundred twenty (120) days of becoming aware of the infringement (or within such shorter period as may be necessary to preserve any legal rights or remedies), Veridian shall have the right to initiate enforcement proceedings at its own cost and expense, with Penterra's reasonable cooperation, including joining as a necessary party if required by applicable law or court rules.
(d) Any monetary recovery obtained from enforcement proceedings (whether by judgment, settlement, or otherwise) shall be applied first to reimburse the enforcing Party for all costs, expenses, and attorneys' fees incurred in connection with such enforcement. Any remaining recovery shall be shared by the Parties in proportion to their respective inventive contributions to the Joint Invention, or as otherwise agreed in writing by the Parties.
Section 5.5 — Cooperation
Each Party shall reasonably cooperate with the other Party in connection with the preparation, filing, prosecution, maintenance, defense, and enforcement of Patent Rights under this Article 5, including by executing all necessary and appropriate assignments, inventor declarations, powers of attorney, and other instruments, and by making its employees, agents, and Site Personnel available for consultations, depositions, and testimony as reasonably requested. Without limiting the foregoing, Site Personnel, including Dr. Catherine Aldridge, Global Principal Investigator, and Dr. Howard Matsuoka, Co-Principal Investigator, shall execute inventor declarations and assignments as necessary and consistent with this Article 5 and the institutional IP policies applicable to their respective institutions. The cooperating Party's reasonable out-of-pocket expenses incurred in connection with such cooperation shall be reimbursed by the requesting Party.
ARTICLE 6 — PUBLICATION RIGHTS
Section 6.1 — Right to Publish
Investigators and Site Personnel shall have the right to publish or present the results of the CLARION trial in peer-reviewed journals and at scientific and medical conferences, subject to the review and approval procedures set forth in this Article 6 and consistent with the provisions of Exhibit G (Intellectual Property and Publication Rights) of the MCTA. The Parties acknowledge the importance of the timely dissemination of clinical trial results for the advancement of medical science and the benefit of patients, and agree that the review procedures described herein are intended to balance the interests of academic publication with the protection of patentable subject matter and Confidential Information.
Section 6.2 — Review Period
Prior to any submission for publication in any journal, presentation at any scientific or medical conference, posting on any preprint server, or other public disclosure, the publishing investigator shall submit the complete proposed manuscript, abstract, poster, slide presentation, or other material (each, a "Proposed Publication") to Penterra for review. Penterra shall have a period of sixty (60) calendar days from the date of receipt of the Proposed Publication (the "Initial Review Period") to review the Proposed Publication for: (a) the inclusion of any Confidential Information of Penterra, and (b) the disclosure of any patentable subject matter.
(i) If Penterra identifies Confidential Information of Penterra contained in the Proposed Publication, Penterra shall notify the publishing investigator in writing, specifying the Confidential Information to be removed or modified. The publishing investigator shall remove or modify such Confidential Information prior to submission of the Proposed Publication.
(ii) If Penterra identifies patentable subject matter in the Proposed Publication, Penterra may request in writing a delay of publication for up to an additional ninety (90) calendar days beyond the expiration of the Initial Review Period (the "Patent Delay Period") to allow for the preparation and filing of one or more patent applications covering such patentable subject matter. During the Patent Delay Period, Penterra shall diligently pursue the preparation and filing of such patent applications.
Section 6.3 — No Unreasonable Withholding
Penterra shall not unreasonably withhold, condition, or delay its consent to the publication or presentation of results of the CLARION trial. In no event shall the total period of delay from the date of Penterra's initial receipt of a Proposed Publication to the date on which the publishing investigator is permitted to submit the Proposed Publication for publication exceed one hundred fifty (150) calendar days (comprising the sixty (60) day Initial Review Period and the ninety (90) day Patent Delay Period). If Penterra fails to provide written notice of any objection or request for delay within the Initial Review Period, consent to publication shall be deemed granted.
Section 6.4 — Investigator Grants and Publication Support
Investigator grants totaling One Million Five Hundred Thousand Dollars ($1,500,000) have been designated under the MCTA for academic publication support. Such grants shall be disbursed to the applicable investigators and site institutions upon acceptance of manuscripts for publication in peer-reviewed journals, in accordance with the schedule and procedures set forth in Exhibit B (Budget and Payment Schedule) of the MCTA. Disbursement of publication support grants shall not be contingent upon Penterra's approval of the content of any accepted manuscript, provided that the manuscript has undergone the review process described in this Article 6.
ARTICLE 7 — CONFIDENTIALITY
Section 7.1 — Incorporation of MCTA Confidentiality Provisions
The confidentiality obligations set forth in the MCTA and Exhibit F thereto (Confidentiality and Data Protection Provisions) are hereby incorporated into this Agreement by reference and shall apply with full force and effect to all information disclosed by either Party to the other Party under or in connection with this Side Letter. Without limiting the generality of the foregoing, each Party shall treat as confidential all Inventions, patent applications, patent prosecution materials, invention disclosures, royalty information, and other proprietary information received from the other Party in connection with this Agreement, and shall not disclose such information to any third party except as expressly permitted by this Agreement, the MCTA, or Exhibit F thereto. The confidentiality obligations set forth in this Article 7 shall remain in effect for a period of ten (10) years from the date of disclosure of the applicable Confidential Information, regardless of the expiration or termination of this Agreement or the MCTA.
Section 7.2 — Patent Applications
Notwithstanding the foregoing confidentiality obligations, the filing and prosecution of patent applications in accordance with Article 5 of this Agreement shall not constitute a breach of the confidentiality obligations set forth herein or in the MCTA, provided that the filing Party uses commercially reasonable efforts to limit the disclosure of Confidential Information in patent applications and related filings to what is necessary and appropriate for patent prosecution purposes. Each Party shall, to the extent practicable, provide the other Party with advance notice of any disclosure of the other Party's Confidential Information in a patent filing and shall reasonably consider the other Party's comments regarding the scope of such disclosure.
ARTICLE 8 — REPRESENTATIONS AND WARRANTIES
Section 8.1 — Penterra Representations
Penterra represents and warrants to Veridian as of the Effective Date as follows:
(a) Penterra has the full right, power, and authority to enter into this Side Letter, to perform its obligations hereunder, and to grant the rights and licenses granted herein, and the execution, delivery, and performance of this Side Letter have been duly authorized by all necessary corporate action.
(b) To Penterra's knowledge, as of the Effective Date, the Investigational Product and related Sponsor IP do not infringe any issued patent or misappropriate any trade secret of any third party, and there is no pending or threatened claim, action, or proceeding alleging such infringement or misappropriation.
(c) Penterra has not granted any rights, licenses, or interests in Sponsor IP to any third party that are inconsistent with the rights and obligations set forth in this Side Letter, and the execution and performance of this Side Letter do not conflict with or constitute a breach of any agreement, obligation, or commitment to which Penterra is a party.
Section 8.2 — Veridian Representations
Veridian represents and warrants to Penterra as of the Effective Date as follows:
(a) Veridian has the full right, power, and authority to enter into this Side Letter, to perform its obligations hereunder, and to bind its member institutions with respect to intellectual property matters arising under the MCTA and this Side Letter, and the execution, delivery, and performance of this Side Letter have been duly authorized by all necessary corporate action and, to the extent required, by the governing bodies of the applicable member institutions.
(b) Veridian has obtained, or prior to the commencement of Protocol activities at each participating site will obtain, appropriate intellectual property assignment or license agreements from Site Personnel sufficient to enable Veridian to comply with its obligations under this Side Letter, including without limitation the assignment obligations set forth in Section 4.2(b) and the cooperation obligations set forth in Section 5.5.
(c) Site Personnel are subject to institutional intellectual property policies that require the assignment or disclosure of Inventions conceived or reduced to practice in the course of their employment or engagement, and such policies are enforceable under applicable law and the terms of employment or engagement of such Site Personnel.
Section 8.3 — No Warranty of Patentability
Neither Party makes any representation or warranty that any Invention will be patentable or that any patent application filed hereunder will result in the issuance of a patent. Neither Party shall be liable to the other Party for the failure of any patent application to issue as a patent or for the invalidity or unenforceability of any patent.
ARTICLE 9 — TERM AND TERMINATION
Section 9.1 — Term
This Side Letter shall be effective as of the Effective Date and shall continue in full force and effect for the duration of the MCTA. Thereafter, this Side Letter shall continue in effect with respect to any provisions that by their nature are intended to survive the termination or expiration of the MCTA, including without limitation the following: ownership of Inventions (Article 4), license grants (Section 2.2, to the extent of any continuing obligations, and Sections 4.4(a) and 4.4(b)), royalty obligations (Section 4.5), patent prosecution and enforcement rights and obligations (Article 5), confidentiality obligations (Article 7), publication rights (Article 6), representations and warranties (Article 8), dispute resolution (Article 10), and general provisions (Article 11).
Section 9.2 — Effect of MCTA Termination
Termination or expiration of the MCTA, whether by its terms, by mutual agreement, or by the exercise of a termination right thereunder, shall not affect:
(a) The Parties' respective ownership interests in Inventions, including Sponsor Sole Inventions, Site Sole Inventions, and Joint Inventions, as determined in accordance with Article 4;
(b) Penterra's exclusive ownership of Study Data, as set forth in Section 3.1;
(c) The license grants for Joint Inventions set forth in Sections 4.4(a) and 4.4(b), which shall remain in full force and effect;
(d) Penterra's royalty obligations under Section 4.5, which shall continue in accordance with their terms;
(e) The Parties' patent prosecution and enforcement rights and obligations under Article 5, which shall survive in accordance with their terms; and
(f) The confidentiality obligations under Article 7, which shall survive for the full ten (10) year period specified therein.
The one hundred twenty (120) day wind-down period set forth in the MCTA's termination provisions shall apply to any ongoing inventive activities under the Protocol, including the completion of experiments, analyses, or other work necessary to properly characterize and document any Invention in progress at the time of termination.
ARTICLE 10 — DISPUTE RESOLUTION
Section 10.1 — Governing Law
This Side Letter shall be governed by and construed in accordance with the laws of the State of New York, without giving effect to any choice-of-law or conflicts-of-law principles that would result in the application of the laws of any other jurisdiction, consistent with the governing law provision of the MCTA.
Section 10.2 — Dispute Resolution Procedures
Any dispute, controversy, or claim arising out of or relating to this Side Letter, or the breach, termination, or validity thereof (other than disputes regarding inventorship or classification of Inventions, which shall be resolved in accordance with Section 4.6), shall be resolved in accordance with the following escalation procedures, consistent with the dispute resolution provisions of the MCTA:
(a) Negotiation. The Parties shall first attempt to resolve the dispute through good-faith negotiation between their designated representatives — Rebecca Liang, Esq., for Penterra, and Gregory Callahan, Esq., for Veridian — for a period of thirty (30) days following written notice from either Party describing the nature of the dispute in reasonable detail.
(b) Mediation. If the dispute is not resolved through negotiation within the thirty (30) day period described in Section 10.2(a), either Party may initiate mediation by delivering written notice to the other Party. The mediation shall be conducted under the Commercial Mediation Rules of the American Arbitration Association ("AAA") then in effect, before a single mediator mutually selected by the Parties. The mediation shall be held in New York, New York, and shall be completed within sixty (60) days of the initiation of the mediation, unless the Parties mutually agree to extend such period. The costs of the mediator shall be shared equally by the Parties.
(c) Binding Arbitration. If the dispute is not resolved through mediation within the sixty (60) day period described in Section 10.2(b), either Party may submit the dispute to final and binding arbitration administered by the AAA in accordance with its Commercial Arbitration Rules then in effect. The arbitration shall be conducted in New York, New York, before a panel of three (3) arbitrators, one selected by each Party and the third selected by the two Party-appointed arbitrators. Each arbitrator shall have significant experience in pharmaceutical industry transactions and intellectual property law. The arbitrators shall render a reasoned written decision within ninety (90) days of the close of the arbitration hearing. The decision of the arbitrators shall be final, binding, and non-appealable (except as provided by applicable law), and judgment upon the award may be entered in any court of competent jurisdiction.
For the avoidance of doubt, disputes regarding inventorship or classification of Inventions as Sponsor Sole Inventions, Site Sole Inventions, or Joint Inventions shall be resolved exclusively through the procedures set forth in Section 4.6 of this Agreement and shall not be subject to the mediation or arbitration procedures described in this Section 10.2.
Section 10.3 — Injunctive Relief
Notwithstanding the dispute resolution procedures set forth in Section 10.2, either Party may seek temporary, preliminary, or permanent injunctive relief or other equitable remedies in the state and federal courts located in New York County, New York, to prevent or restrain any actual or threatened unauthorized use, disclosure, or misappropriation of intellectual property, Inventions, Study Data, or Confidential Information, without the necessity of proving actual damages or posting a bond or other security. Each Party consents to the personal jurisdiction and venue of such courts for purposes of any action seeking injunctive or equitable relief under this Section 10.3.
ARTICLE 11 — GENERAL PROVISIONS
Section 11.1 — Entire Agreement; Relationship to MCTA
This Side Letter, together with the MCTA (including all exhibits and schedules thereto, and in particular Exhibit G — Intellectual Property and Publication Rights), constitutes the entire agreement between the Parties with respect to the subject matter hereof and supersedes all prior and contemporaneous agreements, understandings, negotiations, and discussions, whether oral or written, between the Parties with respect to such subject matter. In the event of any conflict or inconsistency between the provisions of this Side Letter and the provisions of the MCTA (including Exhibit G) with respect to intellectual property matters, the provisions of this Side Letter shall control and govern.
Section 11.2 — Amendments
No amendment, modification, supplement, or waiver of any provision of this Side Letter shall be effective unless set forth in a written instrument executed by duly authorized representatives of both Parties. Any such amendment shall expressly reference this Side Letter and the specific provisions being amended.
Section 11.3 — Assignment
Neither Party may assign, transfer, or delegate this Side Letter or any of its rights, obligations, or interests hereunder without the prior written consent of the other Party, which consent shall not be unreasonably withheld, conditioned, or delayed; provided, however, that either Party may assign this Side Letter without the other Party's consent in connection with a merger, consolidation, reorganization, or sale or transfer of all or substantially all of such Party's assets or business to which this Side Letter relates, provided that the assignee expressly assumes in writing all of the assigning Party's obligations under this Side Letter. Any attempted assignment in violation of this Section 11.3 shall be null and void. This Side Letter shall be binding upon and inure to the benefit of the Parties and their respective permitted successors and assigns.
Section 11.4 — Notices
All notices, requests, demands, consents, and other communications required or permitted under this Side Letter shall be in writing and shall be delivered in accordance with the notice provisions set forth in the MCTA. For purposes of this Side Letter, the designated notice recipients are as follows:
If to Penterra:
Nathaniel Briggs, Esq. Vice President & General Counsel Penterra Pharmaceuticals Corp. 200 Biopharma Boulevard, Suite 1400 Princeton, New Jersey 08540
With a copy to:
Rebecca Liang, Esq. Associate General Counsel, Clinical Affairs Penterra Pharmaceuticals Corp. 200 Biopharma Boulevard, Suite 1400 Princeton, New Jersey 08540
If to Veridian:
Gregory Callahan, Esq. Vice President, Legal & Compliance Veridian Health Research Network, Inc. 750 Research Parkway, 8th Floor Philadelphia, Pennsylvania 19104
Section 11.5 — Severability
If any provision of this Side Letter is held to be invalid, illegal, or unenforceable by a court of competent jurisdiction or an arbitral tribunal, such invalidity, illegality, or unenforceability shall not affect the validity, legality, or enforceability of any other provision of this Side Letter, and the remaining provisions shall continue in full force and effect. In the event of such a determination, the Parties shall negotiate in good faith to replace the invalid, illegal, or unenforceable provision with a valid, legal, and enforceable provision that, to the maximum extent practicable, achieves the economic, business, and other purposes of the original provision.
Section 11.6 — Waiver
No failure or delay by either Party in exercising any right, power, or remedy under this Side Letter shall operate as a waiver thereof, nor shall any single or partial exercise of any right, power, or remedy preclude any other or further exercise thereof or the exercise of any other right, power, or remedy. No waiver of any breach or default under this Side Letter shall constitute a waiver of any subsequent or prior breach or default, whether of the same or a different provision. All waivers must be in writing and signed by the waiving Party to be effective.
Section 11.7 — Counterparts
This Side Letter may be executed in two or more counterparts, each of which shall be deemed an original and all of which together shall constitute one and the same instrument. Execution and delivery of this Side Letter by facsimile, electronic mail (in PDF or similar format), or other electronic means shall have the same legal force and effect as execution and delivery of an original counterpart.
Section 11.8 — Third-Party Beneficiaries
Participating site institutions that are members of the Veridian Health Research Network and that execute Individual Site Agreements (joinders) under the MCTA shall be express third-party beneficiaries of this Side Letter to the extent of their inventive contributions to Joint Inventions and their rights with respect to Site Sole Inventions and publication rights as described herein. Such third-party beneficiary rights shall be enforceable by the applicable site institution directly, subject to the dispute resolution procedures of Article 10. Except as expressly set forth in this Section 11.8, this Side Letter is not intended to, and shall not, confer any rights or remedies upon any person or entity other than the Parties hereto and their permitted successors and assigns.
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SIGNATURE PAGE TO INTELLECTUAL PROPERTY SIDE LETTER
IN WITNESS WHEREOF, the Parties have caused this intellectual Property Side Letter to be executed by their duly authorized representatives as of the date first written above.
PENTERRA PHARMACEUTICALS CORP.
By: ________
Name: Nathaniel Briggs, Esq.
Title: Vice President & General Counsel
Date: June 28, 2023
VERIDIAN HEALTH RESEARCH NETWORK, INC.
By: ________
Name: Dr. Franklin Osei, M.D., Ph.D.
Title: President & Chief Executive Officer
Date: June 28, 2023
ACKNOWLEDGED AND AGREED (Lead Site):
GRAYSTONE UNIVERSITY MEDICAL CENTER
By: ________
Name: Dr. William Corwin, M.D.
Title: President
Date: June 28, 2023

INTELLECTUAL PROPERTY SIDE LETTER

PARTIES

RECITALS

SIGNATURE PAGE TO INTELLECTUAL PROPERTY SIDE LETTER

PENTERRA PHARMACEUTICALS CORP.

VERIDIAN HEALTH RESEARCH NETWORK, INC.

GRAYSTONE UNIVERSITY MEDICAL CENTER

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Parties

Dates

Amounts