Contract analysis

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 sec

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 othe

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

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

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

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

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

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 Inventio

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

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 exp

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 mad

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 unenforc

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

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

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 applicat

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 co

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 p

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

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 i

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 si

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 on

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 se

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 g

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 ap

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 acti

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

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 gran

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 S

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 resoluti

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,

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, wh

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,

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 Pharmaceutical

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

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 an

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 count

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