1018-00004 · Penterra Pharmaceuticals Corp · Transaction Documents/IP & Data

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PRIVILEGED & CONFIDENTIAL ATTORNEY WORK PRODUCT

CALDERWOOD & HARKNESS LLP Attorneys at Law

280 Park Avenue, 34th Floor New York, New York 10017 Telephone: (212) 554-7000 Facsimile: (212) 554-7001 www.calderwoodharkness.com

101 Carnegie Center, Suite 500 Princeton, New Jersey 08540 Telephone: (609) 987-3200

May 22, 2023

Via Email (awhitmore@wjclaw.com) and First Class Mail

Allison Whitmore, Esq. Partner, Life Sciences & Research Institutions Group Whitmore, Jansen & Callahan LLP 1500 Market Street, Suite 3200 Philadelphia, Pennsylvania 19102

Re: Master Clinical Trial Agreement between Penterra Pharmaceuticals Corp. and Veridian Health Research Network, Inc. — Publication Rights Provisions Protocol PPC-4871-III (CLARION) Calderwood & Harkness Matter No. 1018-00004

Dear Allison:

We write on behalf of our client, Penterra Pharmaceuticals Corp. ("Penterra"), in connection with the ongoing negotiation of the Master Clinical Trial Agreement (the "MCTA") between Penterra and Veridian Health Research Network, Inc. ("Veridian") for Protocol PPC-4871-III, the CLARION trial (Clinical Assessment of Response with Longitudinal Investigation in ONcology). This letter follows up on Veridian's initial markup of the MCTA, which we received from your firm on April 28, 2023, as well as the productive telephone discussions our respective teams have had over the past several weeks regarding investigator publication rights under the proposed agreement. As you are aware, the Second Draft MCTA is currently in preparation and is expected to be circulated to your office on or about May 19, 2023. We are transmitting this letter in advance of that circulation — by three days — to provide a detailed framework on the publication rights issue that we intend to incorporate into the revised Exhibit G (Intellectual Property and Publication Rights) of the Second Draft, and to afford Veridian and your firm an opportunity to review and respond to Penterra's proposal before the broader draft is finalized.

The specific issue we address in this letter is Veridian's insistence, as reflected in its proposed revisions to the draft Exhibit G, on unrestricted investigator academic freedom for publication of results arising from the CLARION trial. We understand and appreciate the principles underlying Veridian's position. However, as set forth in greater detail below, Penterra believes that a structured and time-limited sponsor review period — one that fully protects the academic freedom of the investigators while also safeguarding Penterra's legitimate interests in confidential information, patentable subject matter, and data integrity — is both customary and necessary for a study of this magnitude. We respectfully submit the following analysis and compromise proposal for Veridian's consideration.

1. Acknowledgment of Veridian's Position on Academic Freedom

At the outset, Penterra recognizes and respects Veridian's institutional mission and stature. Veridian is a 501(c)(3) tax-exempt research organization operating thirty-eight (38) academic medical centers and affiliated research institutions across fourteen (14) states. As a leading research network, Veridian has a well-established and deeply held commitment to the free exchange of scientific knowledge and the unrestricted dissemination of clinical research findings. Penterra acknowledges that this commitment is not merely aspirational but is, in many respects, foundational to Veridian's ability to attract and retain world-class investigators and to maintain its standing in the academic and scientific community.

We also acknowledge the critical importance of publication rights to the individual investigators who will be leading the CLARION trial. Dr. Catherine Aldridge, M.D., Ph.D., who serves as the Global Principal Investigator and holds the position of Professor of Oncology at Graystone University Medical Center, has built a distinguished career on the strength of her published contributions to the oncology literature. Her academic appointment, NIH funding, and professional reputation depend in significant part on her ability to publish the results of her clinical research in a timely manner. The same is true for Dr. Howard Matsuoka, M.D., the Co-Principal Investigator at Lakemont Medical Center, and for the many sub-investigators across the Veridian Network who will be contributing to this trial. Penterra is mindful of the well-known "publish-or-perish" imperative that governs academic medicine, and we do not wish to impede the professional advancement of any investigator participating in the CLARION trial.

Penterra values the academic collaboration that underlies the CLARION trial and has no interest in suppressing legitimate scientific publication. To the contrary, Penterra's long-term commercial and regulatory interests are best served by transparent, peer-reviewed dissemination of the CLARION trial results. The credibility and uptake of penterafenib (PPC-4871) in the oncology marketplace will depend in no small measure on the trust that the medical community places in the published data, and that trust, in turn, depends on the perception — and the reality — that the investigators were free to report their findings without sponsor interference.

We therefore wish to be clear: the question before us is not whether publication should occur. Penterra fully expects and encourages publication. The question is one of appropriate process and timing — specifically, whether a limited and well-defined sponsor review period should precede the submission of manuscripts and presentations to ensure that certain discrete and legitimate interests of the sponsor are adequately protected. We believe the answer to that question is yes, and we set forth our reasons below.

2. Penterra's Legitimate Interests Requiring a Review Period

Penterra's request for a pre-publication review period is grounded in four distinct but interrelated interests, each of which is standard in the sponsor–investigator relationship and well recognized in both industry practice and academic institutional policy.

Protection of Confidential Information. The MCTA, as currently drafted and as reflected in both parties' markups, includes a ten (10)-year confidentiality term covering all Protocol-related information, specifications relating to the investigational product penterafenib (PPC-4871), study data in all forms, financial terms, and other proprietary materials exchanged between the parties in connection with the CLARION trial. Confidential information encompasses, among other things, Penterra's proprietary formulation data, manufacturing processes, non-public regulatory submissions, and internal analyses of safety and efficacy signals. While investigators are expected to publish the scientific results of the trial, a pre-publication review period is essential to ensure that no confidential information — particularly information of a commercial, financial, or proprietary nature — is inadvertently disclosed in manuscripts or presentations. Even well-intentioned investigators may, in the course of drafting a manuscript, include background information or contextual details that implicate Penterra's trade secrets or other confidential business information. A structured review period allows Penterra to identify and flag such information before it enters the public domain, without in any way constraining the investigator's ability to report scientific findings.

Protection of Patentable Subject Matter. Under the current draft of the MCTA, Penterra retains exclusive ownership of all clinical trial data generated through the CLARION trial. The investigational product penterafenib is covered by a portfolio of issued and pending patents, and the CLARION trial, which involves a novel combination regimen in a specific oncological indication, may generate data that gives rise to additional patentable inventions or discoveries — including, for example, biomarker-driven patient selection strategies, novel dosing regimens, or methods of treatment for particular patient subpopulations. Under United States patent law, a public disclosure of an invention prior to the filing of a patent application may constitute a statutory bar to patentability. Pre-publication review is therefore necessary to afford Penterra adequate time to identify potentially patentable subject matter disclosed in a proposed publication and, if warranted, to prepare and file one or more patent applications before the publication creates a public disclosure. This interest is not merely theoretical; the stakes involved in this trial — both in terms of the commercial value of the penterafenib franchise and the potential for follow-on innovation arising from the CLARION dataset — make patent protection a matter of considerable practical importance.

Accuracy of Data Presentation. As the IND holder (IND No. 157823) and sponsor of the CLARION trial, Penterra bears a regulatory and scientific obligation to ensure that published data accurately reflects the study results as captured through the trial's electronic data capture system (maintained by Pinnacle Data Solutions, Inc.) and central laboratory analyses (performed by Northbridge Bioanalytical Laboratories, Inc.). Penterra's obligation extends to ensuring consistency between published data and the data reported to the United States Food and Drug Administration in connection with the regulatory review of penterafenib. This is not a matter of controlling the investigators' scientific interpretation of the data; rather, it is a quality control measure to ensure that published tables, figures, and statistical analyses are consistent with the source data and are free from transcription or analytical errors. The consequences of inaccurate data publication can be severe — ranging from regulatory inquiries and reputational harm to the issuance of errata or retractions that undermine the credibility of the trial. A review period allows Penterra's biostatistics and medical affairs teams to verify the accuracy of the data presentation before the manuscript is submitted for peer review.

Multi-Site Coordination. The CLARION trial is designed to enroll approximately 1,200 subjects across all thirty-eight (38) Veridian Network sites. The primary endpoint of the study is overall survival, with key secondary endpoints including progression-free survival, objective response rate, and duration of response. These endpoints are assessed on a study-wide basis, using pooled data from all participating sites. Premature or uncoordinated publication of results from a single site — or from a subset of sites — could compromise the integrity of the overall Phase III dataset, introduce selection bias, and potentially affect the regulatory review of the study. In the oncology setting, where survival data is the gold standard for regulatory approval, the risk of fragmentary or premature publication is particularly acute. A structured review and coordination process, overseen by the Global Principal Investigator in consultation with the sponsor, ensures that multi-center data is published in a manner that preserves the scientific integrity of the trial as a whole and that the initial definitive publication of the primary results reflects the complete dataset.

3. Analysis of Veridian's Proposed Language

We turn now to the specific language proposed by Veridian in its April 28, 2023 markup of Exhibit G. As reflected in that markup, Veridian proposes that investigators would have an unrestricted right to publish study results arising from the CLARION trial, subject only to a thirty (30)-day "courtesy" notice to the sponsor. The notice is characterized as a courtesy — not as a condition precedent to publication — and the proposed language contains no mechanism by which the sponsor may request any delay in publication, whether for purposes of patent filing, confidential information review, or data verification. In short, the Veridian proposal contemplates that an investigator would provide Penterra with a copy of a proposed manuscript, wait thirty days, and then submit the manuscript for publication regardless of whether Penterra has completed its review or raised any concerns.

While we understand the spirit in which this language was proposed, we respectfully submit that it is insufficient to protect Penterra's legitimate interests for the following reasons:

First, a thirty (30)-day review period is inadequate for meaningful review of complex oncology trial manuscripts, particularly for a study of the scale and complexity of the CLARION trial. This is an eighty million dollar ($80,000,000) Phase III trial involving 1,200 subjects and a projected duration of sixty (60) months. Manuscripts arising from such a study will often involve dense statistical analyses, multiple subgroup analyses, correlative biomarker data, and extensive supplementary materials. Penterra's review of such manuscripts requires coordination among its biostatistics, medical affairs, regulatory, intellectual property, and legal teams. Thirty days is simply not enough time to conduct a thorough and responsible review, particularly given the need to coordinate across internal departments and, in some cases, with outside patent counsel.

Second, a "courtesy" notice — one that carries no right to request any delay — does not protect Penterra's ability to file patent applications or to identify and request redaction of confidential information. If the notice is purely a courtesy, the review period is a nullity: Penterra could identify patentable subject matter on Day 25 of the review period and have only five days to prepare and file a patent application, which is wholly impracticable. Similarly, if Penterra identifies confidential information in a manuscript, a courtesy-only regime provides no mechanism by which Penterra can request that the information be removed prior to publication.

Third, the proposed language does not address multi-center publication coordination or the role of the Global Principal Investigator in overseeing the publication strategy for the CLARION trial. In the absence of a coordination mechanism, individual site investigators would be free to publish site-specific data at will, potentially undermining the integrity of the multi-center dataset and creating conflicts with the planned primary publication of the study results. The silence of Veridian's proposed language on this point is, in our view, a significant gap that must be addressed regardless of the outcome of the review-period discussion.

4. Penterra's Compromise Proposal: 60-Day Review Period Plus 90-Day Patent Delay

Having identified the shortcomings of Veridian's proposed language, Penterra offers the following compromise framework, which we believe fairly balances the interests of both parties and is consistent with prevailing industry standards for multi-center Phase III clinical trial agreements.

4.1 — 60-Day Sponsor Review Period

Penterra proposes that investigators participating in the CLARION trial may publish results of the study, subject to the following: the investigator shall provide Penterra with a complete copy of the proposed manuscript, abstract, poster, or presentation (each, a "Proposed Publication") at least sixty (60) days prior to the planned date of submission for publication or public presentation. The sixty-day period shall commence on the date of Penterra's receipt of the complete Proposed Publication.

During the sixty (60)-day review period, Penterra shall have the right to:

(a) Review the Proposed Publication for inclusion of Penterra's Confidential Information (as defined in Exhibit F to the MCTA) and request the removal or redaction of any such Confidential Information from the Proposed Publication;

(b) Review the Proposed Publication for accuracy of data presentation as compared against the study database maintained through the electronic data capture system and central laboratory data, and provide written comments to the investigator. The investigator shall consider such comments in good faith. For the avoidance of doubt, the investigator shall not be obligated to accept Penterra's comments to the extent they relate to matters of scientific interpretation, provided that the investigator shall correct any factual or data inaccuracies identified by Penterra; and

If Penterra does not provide any written comments, requests for redaction, or notice of patentable subject matter to the investigator within the sixty (60)-day review period, the investigator shall be free to submit the Proposed Publication for publication or public presentation without further delay or restriction. Penterra's failure to respond within the sixty-day period shall be deemed consent to publication of the Proposed Publication as submitted.

4.2 — Additional 90-Day Patent Filing Delay

If, during the sixty (60)-day review period described in Section 4.1 above, Penterra identifies potentially patentable subject matter in the Proposed Publication, Penterra may request an additional delay of up to ninety (90) days from the date of Penterra's written notification to the investigator (the "Patent Delay Period"), to allow Penterra sufficient time to prepare and file one or more patent applications covering the identified subject matter.

Under this framework, the total maximum delay from the date of the investigator's initial submission of the Proposed Publication to Penterra would be one hundred fifty (150) days (sixty days for the initial review period, plus ninety days for the Patent Delay Period). Penterra believes this total timeline, while longer than the thirty days proposed by Veridian, is well within the range of accepted industry practice and is proportionate to the complexity and commercial significance of the CLARION trial.

The Patent Delay Period shall be available to Penterra only if Penterra provides written notice to the investigator identifying the specific patentable subject matter before the expiration of the initial sixty (60)-day review period. The written notice must describe, with reasonable specificity, the nature of the potentially patentable subject matter and the basis for Penterra's determination that a delay is warranted to permit the filing of a patent application. If Penterra does not exercise the Patent Delay option within the sixty-day window, the investigator shall be free to proceed with publication at the conclusion of the sixty-day review period.

4.3 — Limitations and Safeguards for Investigators

Penterra's proposal includes a number of important limitations and safeguards designed to protect the investigators' academic freedom and to ensure that the review period is not used as a mechanism for suppressing or controlling the content of scientific publications.

First, Penterra shall not have the right to prevent publication entirely. The review and delay rights described above are limited in all cases to the time periods specified (sixty days for the initial review period and an additional ninety days for the Patent Delay Period, if triggered). At the expiration of the applicable review and/or delay period, the investigator shall be free to publish without further restriction, subject only to the removal of any Confidential Information identified during the review period.

Second, Penterra may not require the removal or modification of scientific conclusions, findings, or data interpretations from any Proposed Publication. The distinction here is critical: Penterra may request removal of confidential commercial information (e.g., financial terms, manufacturing specifications, non-public regulatory strategies), but may not interfere with the investigator's scientific analysis, conclusions, or expression of professional opinion regarding the study results.

Third, multi-site publications involving data from more than one Veridian Network site shall be coordinated through the Global Principal Investigator, Dr. Catherine Aldridge, in consultation with Penterra. This coordination mechanism is intended to ensure orderly publication of the multi-center trial results and to avoid conflicting or premature publications that could compromise the integrity of the overall dataset. The Global PI shall be responsible for establishing a publication committee and publication plan, consistent with the ICMJE guidelines on authorship and the Veridian Network's internal publication policies.

Fourth, individual site investigators may publish site-specific data arising from the CLARION trial only after the primary multi-center results have been accepted for publication, or with the prior written consent of both Penterra and the Global Principal Investigator. This limitation is intended to preserve the integrity of the primary publication and to ensure that site-specific data is presented in appropriate context. The restriction is time-limited — once the primary results have been published, individual investigators will be free to publish site-specific analyses subject to the standard sixty-day review process described above.

Fifth, Penterra shall acknowledge the investigators and participating Veridian institutions in any sponsor-initiated publications arising from the CLARION trial data. This obligation runs in both directions: investigators shall acknowledge Penterra's sponsorship in their publications, and Penterra shall credit the contributions of the investigators and the Veridian Network in any publications or presentations initiated by Penterra.

5. Industry Standard and Precedent

Penterra's proposed framework — a sixty (60)-day review period with an additional ninety (90)-day delay for patent protection — is consistent with prevailing industry standards for Phase III multi-center clinical trial agreements in the United States. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline E6(R2) on Good Clinical Practice recognizes the sponsor's legitimate role in the review of clinical trial data and publications, while affirming the investigator's right to report study results. The proposed framework is designed to be fully consistent with the principles articulated in the ICH E6(R2) Guidelines regarding the sponsor–investigator relationship, and we note that the sixty-day-plus-patent-delay structure has been widely adopted in clinical trial agreements between pharmaceutical sponsors and academic research networks comparable to Veridian.

We also draw your attention to the concurrent negotiations regarding the intellectual Property Side Letter (the "IP Side Letter"), which the parties have agreed will be executed concurrently with the MCTA and which addresses, among other things, the ownership and licensing of joint inventions arising from the CLARION trial. The publication rights framework set forth in this letter must be harmonized with the provisions of the IP Side Letter. In particular, the Patent Delay Period described in Section 4.2 above is designed to complement the joint invention provisions of the IP Side Letter by ensuring that neither party's patent rights are prejudiced by premature publication. We expect that the final language of the publication rights provisions will cross-reference the relevant sections of the IP Side Letter and that any ambiguities between the two documents will be resolved through a priority-of-documents clause in the MCTA.

Finally, we note that the proposed framework is consistent with the publication policies of major academic medical centers and research networks, including the policies adopted by the Association of American Medical Colleges (AAMC) and the publication standards endorsed by the International Committee of Medical Journal Editors (ICMJE). These policies generally recognize the appropriateness of a limited pre-publication review period for sponsor-funded clinical trials, provided that the sponsor does not have the right to suppress or materially alter the scientific content of the publication.

6. Proposed Draft Language

In light of the foregoing analysis, Penterra proposes the following revised language for incorporation into Exhibit G to the MCTA (Intellectual Property and Publication Rights). We have attached a complete copy of the proposed language as an enclosure to this letter; however, for ease of reference during your review, we set forth the key provisions below:

Section __.01 — Definitions.

For purposes of this Section, "Proposed Publication" shall mean any manuscript, abstract, poster, slide presentation, oral presentation, or other written or visual communication intended for submission to a peer-reviewed journal, scientific conference, academic symposium, or other public forum, which discloses or is based upon data, results, or information arising from or generated in connection with Protocol PPC-4871-III (the CLARION trial).

Section __.02 — Pre-Publication Review.

(a) Prior to submitting any Proposed Publication to a journal, conference, or other public forum, the Investigator shall provide Sponsor with a complete copy of the Proposed Publication at least sixty (60) calendar days before the planned date of submission or presentation (the "Review Period"). The Review Period shall commence on the date of Sponsor's actual receipt of the complete Proposed Publication, as confirmed by written acknowledgment from Sponsor or Sponsor's designated representative.

(b) During the Review Period, Sponsor may:

(i) Review the Proposed Publication for inclusion of Sponsor's Confidential Information (as defined in Exhibit F) and request in writing the removal or redaction of any such Confidential Information. The Investigator shall comply with any reasonable request for removal or redaction of Confidential Information, provided that such removal or redaction does not materially impair the scientific integrity of the Proposed Publication;

(ii) Review the Proposed Publication for accuracy of data presentation and provide written comments to the Investigator. The Investigator shall consider Sponsor's comments in good faith and shall correct any factual or data inaccuracies identified by Sponsor. For the avoidance of doubt, the Investigator shall not be obligated to accept Sponsor's comments with respect to matters of scientific interpretation, analysis, or opinion;

(iii) Review the Proposed Publication to identify any potentially patentable subject matter disclosed therein and, if applicable, provide notice to the Investigator in accordance with Section __.03 below.

(c) If Sponsor does not provide any written comments, requests for redaction, or notice of patentable subject matter to the Investigator within the Review Period, Sponsor shall be deemed to have consented to the submission and publication of the Proposed Publication as submitted, and the Investigator shall be free to proceed with submission without further delay.

Section __.03 — Patent Filing Delay.

(a) If, during the Review Period, Sponsor identifies potentially patentable subject matter in the Proposed Publication, Sponsor may, by written notice to the Investigator delivered prior to the expiration of the Review Period, request an additional delay of up to ninety (90) calendar days from the date of such notice (the "Patent Delay Period") to permit Sponsor to prepare and file one or more patent applications relating to the identified subject matter. Such written notice shall describe, with reasonable specificity, the nature of the potentially patentable subject matter.

(b) The total delay from the date of the Investigator's initial submission of the Proposed Publication to Sponsor to the date on which the Investigator may submit the Proposed Publication for publication shall not exceed one hundred fifty (150) calendar days (the Review Period plus the Patent Delay Period).

(c) If Sponsor does not deliver a timely written notice under Section __.03(a) prior to the expiration of the Review Period, Sponsor shall have no right to delay publication beyond the expiration of the Review Period.

Section __.04 — No Suppression of Scientific Content.

Notwithstanding any other provision of this Exhibit G, Sponsor shall not have the right to prevent publication of a Proposed Publication or to require the Investigator to remove, alter, or suppress scientific conclusions, findings, data, or data interpretations from any Proposed Publication. Sponsor's rights under this Section are limited to the review and delay periods specified in Sections .02 and .03 and to the removal of Confidential Information as set forth in Section __.02(b)(i).

Section __.05 — Multi-Center Publication Coordination.

(a) Multi-site publications involving data from more than one Institution site participating in the CLARION trial shall be coordinated through the Global Principal Investigator, Dr. Catherine Aldridge, M.D., Ph.D., in consultation with Sponsor. The Global Principal Investigator shall establish a publication committee composed of representatives of the participating sites and Sponsor, which shall develop a publication plan for the orderly dissemination of the CLARION trial results.

(b) Individual site Investigators may publish site-specific data arising from the CLARION trial only after the primary multi-center results have been accepted for publication in a peer-reviewed journal, or with the prior written consent of both Sponsor and the Global Principal Investigator.

Section __.06 — Acknowledgment.

(a) In any Proposed Publication submitted by an Investigator, the Investigator shall acknowledge Sponsor's financial support of the CLARION trial in a manner consistent with applicable journal or conference requirements.

(b) In any publication or presentation initiated by Sponsor that includes data from the CLARION trial, Sponsor shall acknowledge the contributions of the Investigators and the participating institutions of the Veridian Health Research Network.

Section __.07 — Relationship to Confidentiality Provisions.

The publication rights set forth in this Section are subject to the confidentiality provisions of Exhibit F to the Agreement, including without limitation the ten (10)-year confidentiality term specified therein. Nothing in this Section shall be construed to relieve the Investigator of the Investigator's obligations under Exhibit F with respect to Confidential Information, except to the extent that the Investigator is expressly permitted to include information in a Proposed Publication in accordance with this Section after the completion of the Review Period and, if applicable, the Patent Delay Period.

Section __.08 — Investigator Publication Grants.

The investigator grants in the aggregate amount of One Million Five Hundred Thousand Dollars ($1,500,000) provided under this Agreement are payable upon acceptance of manuscripts for publication in peer-reviewed journals, in accordance with the payment schedule set forth in Exhibit D. For the avoidance of doubt, the payment of such grants is contingent solely upon the acceptance of the manuscript for publication and is independent of the Review Period and Patent Delay Period set forth in this Section. The availability of the investigator grants shall not be conditioned upon the Investigator's acceptance of Sponsor's comments during the Review Period, nor shall the grants constitute a mechanism for Sponsor to exercise control over the scientific content of any Proposed Publication.

7. Relationship to Other MCTA Provisions

The publication rights framework proposed above must be read in conjunction with several other provisions of the MCTA. For completeness, and to assist your review, we summarize the key interrelationships as follows:

Exhibit F — Confidentiality and Data Protection Provisions. Exhibit F establishes a ten (10)-year confidentiality term covering all Protocol-related information exchanged between the parties. The publication rights provisions cross-reference Exhibit F to ensure that any Proposed Publication is reviewed for Confidential Information prior to submission. The confidentiality provisions also include carve-outs for disclosures to Institutional Review Boards (IRBs), Data Safety Monitoring Boards (DSMBs), and regulatory authorities, which are unaffected by the publication review process.

Exhibit G — Intellectual Property Provisions. In addition to the publication rights provisions set forth above, Exhibit G addresses Penterra's exclusive ownership of all clinical trial data generated in connection with the CLARION trial and the retention by each party of its pre-existing intellectual property. Joint inventions arising from the CLARION trial are governed by the IP Side Letter, which is being negotiated concurrently with the MCTA. The publication review and Patent Delay Period provisions are designed to protect the patent rights addressed in the IP Side Letter, and the final language of both documents must be harmonized to ensure consistency.

Exhibit H — Regulatory Compliance Representations. Exhibit H contains the parties' representations and warranties regarding regulatory compliance, including financial disclosure obligations under 21 C.F.R. Part 54 and reporting obligations under the Physician Payments Sunshine Act (Section 6002 of the Affordable Care Act) and the Centers for Medicare & Medicaid Services Open Payments program. The investigator publication grants described in Section __.08 above may constitute "transfers of value" reportable under the Sunshine Act, and the publication rights provisions should be reviewed in conjunction with Exhibit H to ensure that all reporting obligations are properly addressed.

Exhibit I — Form of Investigator Undertaking. Each investigator participating in the CLARION trial will execute an Investigator Undertaking in the form attached to the MCTA as Exhibit I, in which the investigator agrees to comply with, among other things, the publication provisions set forth in Exhibit G. The Investigator Undertaking serves as the contractual mechanism by which the publication review and delay provisions are made binding on individual investigators, and the language of the Investigator Undertaking must be updated to reflect the agreed publication rights framework.

Site Record Retention. The MCTA requires that participating sites retain source documents, case report forms, and related study records for a minimum period of fifteen (15) years following the completion of the CLARION trial. This record retention obligation supports the long-term integrity of the published data and provides a basis for verification of published results in the event of regulatory inquiry or scientific audit.

Penterra wishes to emphasize a point of principle that informs all of these provisions: data ownership and publication rights are distinct concepts. Under the MCTA, Penterra retains exclusive ownership of all clinical trial data. Publication rights, as set forth in the proposed language, constitute a license granted to the investigators — a license that is broad, well-defined, and subject only to the limited review and delay provisions described above. The publication review framework protects both Penterra's ownership interest in the data and the investigators' licensed right to publish, and we believe the proposed language strikes an appropriate and commercially reasonable balance between these interests.

8. Request for Response and Next Steps

We respectfully request that Veridian and your firm review the foregoing proposal and provide a written response by no later than May 30, 2023. Our objective is to reach agreement on the publication rights language in sufficient time for it to be incorporated into the Second Draft MCTA, which is currently being finalized for circulation. To the extent that Veridian has specific comments, counterproposals, or concerns regarding any aspect of the proposal set forth in this letter, we would welcome the opportunity to discuss them either by telephone or in a meeting at your convenience.

We are mindful that the parties continue to have open items on several other provisions of the MCTA, including but not limited to subject-injury indemnification and liability allocation, insurance requirements and limits, payment milestones and invoicing procedures, and protocol-deviation liability. We believe the publication rights issue can and should be resolved in parallel with these other matters, and we encourage both sides to proceed on all fronts simultaneously so as not to introduce unnecessary delay into the overall negotiation timeline.

As you know, the parties have agreed to a target signing date that is driven in significant part by the need to have the MCTA fully executed and in place well in advance of the target first patient in date of August 14, 2023. We are committed to meeting that timeline and would appreciate Veridian's cooperation in ensuring that the publication rights issue — which we believe is close to resolution — does not become a gating item.

Finally, should it be helpful or necessary to address the publication rights issue (along with any remaining open items) in a broader in-person negotiation session, we are prepared to travel to your Philadelphia office for that purpose. We understand that such a session may be scheduled for early June; should that come to pass, we would suggest June 9, 2023, as a potential date, and we would be pleased to include the publication rights discussion on the agenda for that meeting.

We wish to express our sincere appreciation for the collaborative and professional approach that Veridian and your firm have brought to this negotiation. The CLARION trial represents a significant opportunity for both Penterra and Veridian, and we are confident that the parties can arrive at a publication rights framework that fully supports investigator academic freedom while also protecting the legitimate interests of the sponsor. Penterra remains firmly committed to that objective, and we look forward to your response.

Sincerely,

CALDERWOOD & HARKNESS LLP

By: ________

Miriam Calloway Partner, Healthcare & Life Sciences Practice Group 280 Park Avenue, 34th Floor New York, New York 10017 Telephone: (212) 554-7036

Email: mcalloway@calderwoodharkness.com

cc: (via email)

Nathaniel Briggs, Esq. — Vice President & General Counsel, Penterra Pharmaceuticals Corp.

Rebecca Liang, Esq. — Associate General Counsel, Clinical Affairs, Penterra Pharmaceuticals Corp.

Joel Strauss, Esq. — Partner, Calderwood & Harkness LLP

Sean Morrissey, Esq. — Associate, Calderwood & Harkness LLP

Christopher Aiken, Esq. — Associate, Calderwood & Harkness LLP

David Kesselman, Esq. — Associate, Whitmore, Jansen & Callahan LLP

Enclosure:

Proposed Revised Language for Exhibit G, Section __ (Publication Rights) — Master Clinical Trial Agreement between Penterra Pharmaceuticals Corp. and Veridian Health Research Network, Inc. (Protocol PPC-4871-III / CLARION)

PRIVILEGED & CONFIDENTIAL ATTORNEY WORK PRODUCT
CALDERWOOD & HARKNESS LLP Attorneys at Law
280 Park Avenue, 34th Floor New York, New York 10017 Telephone: (212) 554-7000 Facsimile: (212) 554-7001 www.calderwoodharkness.com
101 Carnegie Center, Suite 500 Princeton, New Jersey 08540 Telephone: (609) 987-3200
May 22, 2023
Via Email (awhitmore@wjclaw.com) and First Class Mail
Allison Whitmore, Esq. Partner, Life Sciences & Research Institutions Group Whitmore, Jansen & Callahan LLP 1500 Market Street, Suite 3200 Philadelphia, Pennsylvania 19102
Re: Master Clinical Trial Agreement between Penterra Pharmaceuticals Corp. and Veridian Health Research Network, Inc. — Publication Rights Provisions Protocol PPC-4871-III (CLARION) Calderwood & Harkness Matter No. 1018-00004
Dear Allison:
We write on behalf of our client, Penterra Pharmaceuticals Corp. ("Penterra"), in connection with the ongoing negotiation of the Master Clinical Trial Agreement (the "MCTA") between Penterra and Veridian Health Research Network, Inc. ("Veridian") for Protocol PPC-4871-III, the CLARION trial (Clinical Assessment of Response with Longitudinal Investigation in ONcology). This letter follows up on Veridian's initial markup of the MCTA, which we received from your firm on April 28, 2023, as well as the productive telephone discussions our respective teams have had over the past several weeks regarding investigator publication rights under the proposed agreement. As you are aware, the Second Draft MCTA is currently in preparation and is expected to be circulated to your office on or about May 19, 2023. We are transmitting this letter in advance of that circulation — by three days — to provide a detailed framework on the publication rights issue that we intend to incorporate into the revised Exhibit G (Intellectual Property and Publication Rights) of the Second Draft, and to afford Veridian and your firm an opportunity to review and respond to Penterra's proposal before the broader draft is finalized.
The specific issue we address in this letter is Veridian's insistence, as reflected in its proposed revisions to the draft Exhibit G, on unrestricted investigator academic freedom for publication of results arising from the CLARION trial. We understand and appreciate the principles underlying Veridian's position. However, as set forth in greater detail below, Penterra believes that a structured and time-limited sponsor review period — one that fully protects the academic freedom of the investigators while also safeguarding Penterra's legitimate interests in confidential information, patentable subject matter, and data integrity — is both customary and necessary for a study of this magnitude. We respectfully submit the following analysis and compromise proposal for Veridian's consideration.
1. Acknowledgment of Veridian's Position on Academic Freedom
At the outset, Penterra recognizes and respects Veridian's institutional mission and stature. Veridian is a 501(c)(3) tax-exempt research organization operating thirty-eight (38) academic medical centers and affiliated research institutions across fourteen (14) states. As a leading research network, Veridian has a well-established and deeply held commitment to the free exchange of scientific knowledge and the unrestricted dissemination of clinical research findings. Penterra acknowledges that this commitment is not merely aspirational but is, in many respects, foundational to Veridian's ability to attract and retain world-class investigators and to maintain its standing in the academic and scientific community.
We also acknowledge the critical importance of publication rights to the individual investigators who will be leading the CLARION trial. Dr. Catherine Aldridge, M.D., Ph.D., who serves as the Global Principal Investigator and holds the position of Professor of Oncology at Graystone University Medical Center, has built a distinguished career on the strength of her published contributions to the oncology literature. Her academic appointment, NIH funding, and professional reputation depend in significant part on her ability to publish the results of her clinical research in a timely manner. The same is true for Dr. Howard Matsuoka, M.D., the Co-Principal Investigator at Lakemont Medical Center, and for the many sub-investigators across the Veridian Network who will be contributing to this trial. Penterra is mindful of the well-known "publish-or-perish" imperative that governs academic medicine, and we do not wish to impede the professional advancement of any investigator participating in the CLARION trial.
Penterra values the academic collaboration that underlies the CLARION trial and has no interest in suppressing legitimate scientific publication. To the contrary, Penterra's long-term commercial and regulatory interests are best served by transparent, peer-reviewed dissemination of the CLARION trial results. The credibility and uptake of penterafenib (PPC-4871) in the oncology marketplace will depend in no small measure on the trust that the medical community places in the published data, and that trust, in turn, depends on the perception — and the reality — that the investigators were free to report their findings without sponsor interference.
We therefore wish to be clear: the question before us is not whether publication should occur. Penterra fully expects and encourages publication. The question is one of appropriate process and timing — specifically, whether a limited and well-defined sponsor review period should precede the submission of manuscripts and presentations to ensure that certain discrete and legitimate interests of the sponsor are adequately protected. We believe the answer to that question is yes, and we set forth our reasons below.
2. Penterra's Legitimate Interests Requiring a Review Period
Penterra's request for a pre-publication review period is grounded in four distinct but interrelated interests, each of which is standard in the sponsor–investigator relationship and well recognized in both industry practice and academic institutional policy.
Protection of Confidential Information. The MCTA, as currently drafted and as reflected in both parties' markups, includes a ten (10)-year confidentiality term covering all Protocol-related information, specifications relating to the investigational product penterafenib (PPC-4871), study data in all forms, financial terms, and other proprietary materials exchanged between the parties in connection with the CLARION trial. Confidential information encompasses, among other things, Penterra's proprietary formulation data, manufacturing processes, non-public regulatory submissions, and internal analyses of safety and efficacy signals. While investigators are expected to publish the scientific results of the trial, a pre-publication review period is essential to ensure that no confidential information — particularly information of a commercial, financial, or proprietary nature — is inadvertently disclosed in manuscripts or presentations. Even well-intentioned investigators may, in the course of drafting a manuscript, include background information or contextual details that implicate Penterra's trade secrets or other confidential business information. A structured review period allows Penterra to identify and flag such information before it enters the public domain, without in any way constraining the investigator's ability to report scientific findings.
Protection of Patentable Subject Matter. Under the current draft of the MCTA, Penterra retains exclusive ownership of all clinical trial data generated through the CLARION trial. The investigational product penterafenib is covered by a portfolio of issued and pending patents, and the CLARION trial, which involves a novel combination regimen in a specific oncological indication, may generate data that gives rise to additional patentable inventions or discoveries — including, for example, biomarker-driven patient selection strategies, novel dosing regimens, or methods of treatment for particular patient subpopulations. Under United States patent law, a public disclosure of an invention prior to the filing of a patent application may constitute a statutory bar to patentability. Pre-publication review is therefore necessary to afford Penterra adequate time to identify potentially patentable subject matter disclosed in a proposed publication and, if warranted, to prepare and file one or more patent applications before the publication creates a public disclosure. This interest is not merely theoretical; the stakes involved in this trial — both in terms of the commercial value of the penterafenib franchise and the potential for follow-on innovation arising from the CLARION dataset — make patent protection a matter of considerable practical importance.
Accuracy of Data Presentation. As the IND holder (IND No. 157823) and sponsor of the CLARION trial, Penterra bears a regulatory and scientific obligation to ensure that published data accurately reflects the study results as captured through the trial's electronic data capture system (maintained by Pinnacle Data Solutions, Inc.) and central laboratory analyses (performed by Northbridge Bioanalytical Laboratories, Inc.). Penterra's obligation extends to ensuring consistency between published data and the data reported to the United States Food and Drug Administration in connection with the regulatory review of penterafenib. This is not a matter of controlling the investigators' scientific interpretation of the data; rather, it is a quality control measure to ensure that published tables, figures, and statistical analyses are consistent with the source data and are free from transcription or analytical errors. The consequences of inaccurate data publication can be severe — ranging from regulatory inquiries and reputational harm to the issuance of errata or retractions that undermine the credibility of the trial. A review period allows Penterra's biostatistics and medical affairs teams to verify the accuracy of the data presentation before the manuscript is submitted for peer review.
Multi-Site Coordination. The CLARION trial is designed to enroll approximately 1,200 subjects across all thirty-eight (38) Veridian Network sites. The primary endpoint of the study is overall survival, with key secondary endpoints including progression-free survival, objective response rate, and duration of response. These endpoints are assessed on a study-wide basis, using pooled data from all participating sites. Premature or uncoordinated publication of results from a single site — or from a subset of sites — could compromise the integrity of the overall Phase III dataset, introduce selection bias, and potentially affect the regulatory review of the study. In the oncology setting, where survival data is the gold standard for regulatory approval, the risk of fragmentary or premature publication is particularly acute. A structured review and coordination process, overseen by the Global Principal Investigator in consultation with the sponsor, ensures that multi-center data is published in a manner that preserves the scientific integrity of the trial as a whole and that the initial definitive publication of the primary results reflects the complete dataset.
3. Analysis of Veridian's Proposed Language
We turn now to the specific language proposed by Veridian in its April 28, 2023 markup of Exhibit G. As reflected in that markup, Veridian proposes that investigators would have an unrestricted right to publish study results arising from the CLARION trial, subject only to a thirty (30)-day "courtesy" notice to the sponsor. The notice is characterized as a courtesy — not as a condition precedent to publication — and the proposed language contains no mechanism by which the sponsor may request any delay in publication, whether for purposes of patent filing, confidential information review, or data verification. In short, the Veridian proposal contemplates that an investigator would provide Penterra with a copy of a proposed manuscript, wait thirty days, and then submit the manuscript for publication regardless of whether Penterra has completed its review or raised any concerns.
While we understand the spirit in which this language was proposed, we respectfully submit that it is insufficient to protect Penterra's legitimate interests for the following reasons:
First, a thirty (30)-day review period is inadequate for meaningful review of complex oncology trial manuscripts, particularly for a study of the scale and complexity of the CLARION trial. This is an eighty million dollar ($80,000,000) Phase III trial involving 1,200 subjects and a projected duration of sixty (60) months. Manuscripts arising from such a study will often involve dense statistical analyses, multiple subgroup analyses, correlative biomarker data, and extensive supplementary materials. Penterra's review of such manuscripts requires coordination among its biostatistics, medical affairs, regulatory, intellectual property, and legal teams. Thirty days is simply not enough time to conduct a thorough and responsible review, particularly given the need to coordinate across internal departments and, in some cases, with outside patent counsel.
Second, a "courtesy" notice — one that carries no right to request any delay — does not protect Penterra's ability to file patent applications or to identify and request redaction of confidential information. If the notice is purely a courtesy, the review period is a nullity: Penterra could identify patentable subject matter on Day 25 of the review period and have only five days to prepare and file a patent application, which is wholly impracticable. Similarly, if Penterra identifies confidential information in a manuscript, a courtesy-only regime provides no mechanism by which Penterra can request that the information be removed prior to publication.
Third, the proposed language does not address multi-center publication coordination or the role of the Global Principal Investigator in overseeing the publication strategy for the CLARION trial. In the absence of a coordination mechanism, individual site investigators would be free to publish site-specific data at will, potentially undermining the integrity of the multi-center dataset and creating conflicts with the planned primary publication of the study results. The silence of Veridian's proposed language on this point is, in our view, a significant gap that must be addressed regardless of the outcome of the review-period discussion.
4. Penterra's Compromise Proposal: 60-Day Review Period Plus 90-Day Patent Delay
Having identified the shortcomings of Veridian's proposed language, Penterra offers the following compromise framework, which we believe fairly balances the interests of both parties and is consistent with prevailing industry standards for multi-center Phase III clinical trial agreements.
4.1 — 60-Day Sponsor Review Period
Penterra proposes that investigators participating in the CLARION trial may publish results of the study, subject to the following: the investigator shall provide Penterra with a complete copy of the proposed manuscript, abstract, poster, or presentation (each, a "Proposed Publication") at least sixty (60) days prior to the planned date of submission for publication or public presentation. The sixty-day period shall commence on the date of Penterra's receipt of the complete Proposed Publication.
During the sixty (60)-day review period, Penterra shall have the right to:
(a) Review the Proposed Publication for inclusion of Penterra's Confidential Information (as defined in Exhibit F to the MCTA) and request the removal or redaction of any such Confidential Information from the Proposed Publication;
(b) Review the Proposed Publication for accuracy of data presentation as compared against the study database maintained through the electronic data capture system and central laboratory data, and provide written comments to the investigator. The investigator shall consider such comments in good faith. For the avoidance of doubt, the investigator shall not be obligated to accept Penterra's comments to the extent they relate to matters of scientific interpretation, provided that the investigator shall correct any factual or data inaccuracies identified by Penterra; and
(c) Review the Proposed Publication to identify any potentially patentable subject matter disclosed therein.
If Penterra does not provide any written comments, requests for redaction, or notice of patentable subject matter to the investigator within the sixty (60)-day review period, the investigator shall be free to submit the Proposed Publication for publication or public presentation without further delay or restriction. Penterra's failure to respond within the sixty-day period shall be deemed consent to publication of the Proposed Publication as submitted.
4.2 — Additional 90-Day Patent Filing Delay
If, during the sixty (60)-day review period described in Section 4.1 above, Penterra identifies potentially patentable subject matter in the Proposed Publication, Penterra may request an additional delay of up to ninety (90) days from the date of Penterra's written notification to the investigator (the "Patent Delay Period"), to allow Penterra sufficient time to prepare and file one or more patent applications covering the identified subject matter.
Under this framework, the total maximum delay from the date of the investigator's initial submission of the Proposed Publication to Penterra would be one hundred fifty (150) days (sixty days for the initial review period, plus ninety days for the Patent Delay Period). Penterra believes this total timeline, while longer than the thirty days proposed by Veridian, is well within the range of accepted industry practice and is proportionate to the complexity and commercial significance of the CLARION trial.
The Patent Delay Period shall be available to Penterra only if Penterra provides written notice to the investigator identifying the specific patentable subject matter before the expiration of the initial sixty (60)-day review period. The written notice must describe, with reasonable specificity, the nature of the potentially patentable subject matter and the basis for Penterra's determination that a delay is warranted to permit the filing of a patent application. If Penterra does not exercise the Patent Delay option within the sixty-day window, the investigator shall be free to proceed with publication at the conclusion of the sixty-day review period.
4.3 — Limitations and Safeguards for Investigators
Penterra's proposal includes a number of important limitations and safeguards designed to protect the investigators' academic freedom and to ensure that the review period is not used as a mechanism for suppressing or controlling the content of scientific publications.
First, Penterra shall not have the right to prevent publication entirely. The review and delay rights described above are limited in all cases to the time periods specified (sixty days for the initial review period and an additional ninety days for the Patent Delay Period, if triggered). At the expiration of the applicable review and/or delay period, the investigator shall be free to publish without further restriction, subject only to the removal of any Confidential Information identified during the review period.
Second, Penterra may not require the removal or modification of scientific conclusions, findings, or data interpretations from any Proposed Publication. The distinction here is critical: Penterra may request removal of confidential commercial information (e.g., financial terms, manufacturing specifications, non-public regulatory strategies), but may not interfere with the investigator's scientific analysis, conclusions, or expression of professional opinion regarding the study results.
Third, multi-site publications involving data from more than one Veridian Network site shall be coordinated through the Global Principal Investigator, Dr. Catherine Aldridge, in consultation with Penterra. This coordination mechanism is intended to ensure orderly publication of the multi-center trial results and to avoid conflicting or premature publications that could compromise the integrity of the overall dataset. The Global PI shall be responsible for establishing a publication committee and publication plan, consistent with the ICMJE guidelines on authorship and the Veridian Network's internal publication policies.
Fourth, individual site investigators may publish site-specific data arising from the CLARION trial only after the primary multi-center results have been accepted for publication, or with the prior written consent of both Penterra and the Global Principal Investigator. This limitation is intended to preserve the integrity of the primary publication and to ensure that site-specific data is presented in appropriate context. The restriction is time-limited — once the primary results have been published, individual investigators will be free to publish site-specific analyses subject to the standard sixty-day review process described above.
Fifth, Penterra shall acknowledge the investigators and participating Veridian institutions in any sponsor-initiated publications arising from the CLARION trial data. This obligation runs in both directions: investigators shall acknowledge Penterra's sponsorship in their publications, and Penterra shall credit the contributions of the investigators and the Veridian Network in any publications or presentations initiated by Penterra.
5. Industry Standard and Precedent
Penterra's proposed framework — a sixty (60)-day review period with an additional ninety (90)-day delay for patent protection — is consistent with prevailing industry standards for Phase III multi-center clinical trial agreements in the United States. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guideline E6(R2) on Good Clinical Practice recognizes the sponsor's legitimate role in the review of clinical trial data and publications, while affirming the investigator's right to report study results. The proposed framework is designed to be fully consistent with the principles articulated in the ICH E6(R2) Guidelines regarding the sponsor–investigator relationship, and we note that the sixty-day-plus-patent-delay structure has been widely adopted in clinical trial agreements between pharmaceutical sponsors and academic research networks comparable to Veridian.
We also draw your attention to the concurrent negotiations regarding the intellectual Property Side Letter (the "IP Side Letter"), which the parties have agreed will be executed concurrently with the MCTA and which addresses, among other things, the ownership and licensing of joint inventions arising from the CLARION trial. The publication rights framework set forth in this letter must be harmonized with the provisions of the IP Side Letter. In particular, the Patent Delay Period described in Section 4.2 above is designed to complement the joint invention provisions of the IP Side Letter by ensuring that neither party's patent rights are prejudiced by premature publication. We expect that the final language of the publication rights provisions will cross-reference the relevant sections of the IP Side Letter and that any ambiguities between the two documents will be resolved through a priority-of-documents clause in the MCTA.
Finally, we note that the proposed framework is consistent with the publication policies of major academic medical centers and research networks, including the policies adopted by the Association of American Medical Colleges (AAMC) and the publication standards endorsed by the International Committee of Medical Journal Editors (ICMJE). These policies generally recognize the appropriateness of a limited pre-publication review period for sponsor-funded clinical trials, provided that the sponsor does not have the right to suppress or materially alter the scientific content of the publication.
6. Proposed Draft Language
In light of the foregoing analysis, Penterra proposes the following revised language for incorporation into Exhibit G to the MCTA (Intellectual Property and Publication Rights). We have attached a complete copy of the proposed language as an enclosure to this letter; however, for ease of reference during your review, we set forth the key provisions below:
Section __.01 — Definitions.
For purposes of this Section, "Proposed Publication" shall mean any manuscript, abstract, poster, slide presentation, oral presentation, or other written or visual communication intended for submission to a peer-reviewed journal, scientific conference, academic symposium, or other public forum, which discloses or is based upon data, results, or information arising from or generated in connection with Protocol PPC-4871-III (the CLARION trial).
Section __.02 — Pre-Publication Review.
(a) Prior to submitting any Proposed Publication to a journal, conference, or other public forum, the Investigator shall provide Sponsor with a complete copy of the Proposed Publication at least sixty (60) calendar days before the planned date of submission or presentation (the "Review Period"). The Review Period shall commence on the date of Sponsor's actual receipt of the complete Proposed Publication, as confirmed by written acknowledgment from Sponsor or Sponsor's designated representative.
(b) During the Review Period, Sponsor may:
(i) Review the Proposed Publication for inclusion of Sponsor's Confidential Information (as defined in Exhibit F) and request in writing the removal or redaction of any such Confidential Information. The Investigator shall comply with any reasonable request for removal or redaction of Confidential Information, provided that such removal or redaction does not materially impair the scientific integrity of the Proposed Publication;
(ii) Review the Proposed Publication for accuracy of data presentation and provide written comments to the Investigator. The Investigator shall consider Sponsor's comments in good faith and shall correct any factual or data inaccuracies identified by Sponsor. For the avoidance of doubt, the Investigator shall not be obligated to accept Sponsor's comments with respect to matters of scientific interpretation, analysis, or opinion;
(iii) Review the Proposed Publication to identify any potentially patentable subject matter disclosed therein and, if applicable, provide notice to the Investigator in accordance with Section __.03 below.
(c) If Sponsor does not provide any written comments, requests for redaction, or notice of patentable subject matter to the Investigator within the Review Period, Sponsor shall be deemed to have consented to the submission and publication of the Proposed Publication as submitted, and the Investigator shall be free to proceed with submission without further delay.
Section __.03 — Patent Filing Delay.
(a) If, during the Review Period, Sponsor identifies potentially patentable subject matter in the Proposed Publication, Sponsor may, by written notice to the Investigator delivered prior to the expiration of the Review Period, request an additional delay of up to ninety (90) calendar days from the date of such notice (the "Patent Delay Period") to permit Sponsor to prepare and file one or more patent applications relating to the identified subject matter. Such written notice shall describe, with reasonable specificity, the nature of the potentially patentable subject matter.
(b) The total delay from the date of the Investigator's initial submission of the Proposed Publication to Sponsor to the date on which the Investigator may submit the Proposed Publication for publication shall not exceed one hundred fifty (150) calendar days (the Review Period plus the Patent Delay Period).
(c) If Sponsor does not deliver a timely written notice under Section __.03(a) prior to the expiration of the Review Period, Sponsor shall have no right to delay publication beyond the expiration of the Review Period.
Section __.04 — No Suppression of Scientific Content.
Notwithstanding any other provision of this Exhibit G, Sponsor shall not have the right to prevent publication of a Proposed Publication or to require the Investigator to remove, alter, or suppress scientific conclusions, findings, data, or data interpretations from any Proposed Publication. Sponsor's rights under this Section are limited to the review and delay periods specified in Sections .02 and .03 and to the removal of Confidential Information as set forth in Section __.02(b)(i).
Section __.05 — Multi-Center Publication Coordination.
(a) Multi-site publications involving data from more than one Institution site participating in the CLARION trial shall be coordinated through the Global Principal Investigator, Dr. Catherine Aldridge, M.D., Ph.D., in consultation with Sponsor. The Global Principal Investigator shall establish a publication committee composed of representatives of the participating sites and Sponsor, which shall develop a publication plan for the orderly dissemination of the CLARION trial results.
(b) Individual site Investigators may publish site-specific data arising from the CLARION trial only after the primary multi-center results have been accepted for publication in a peer-reviewed journal, or with the prior written consent of both Sponsor and the Global Principal Investigator.
Section __.06 — Acknowledgment.
(a) In any Proposed Publication submitted by an Investigator, the Investigator shall acknowledge Sponsor's financial support of the CLARION trial in a manner consistent with applicable journal or conference requirements.
(b) In any publication or presentation initiated by Sponsor that includes data from the CLARION trial, Sponsor shall acknowledge the contributions of the Investigators and the participating institutions of the Veridian Health Research Network.
Section __.07 — Relationship to Confidentiality Provisions.
The publication rights set forth in this Section are subject to the confidentiality provisions of Exhibit F to the Agreement, including without limitation the ten (10)-year confidentiality term specified therein. Nothing in this Section shall be construed to relieve the Investigator of the Investigator's obligations under Exhibit F with respect to Confidential Information, except to the extent that the Investigator is expressly permitted to include information in a Proposed Publication in accordance with this Section after the completion of the Review Period and, if applicable, the Patent Delay Period.
Section __.08 — Investigator Publication Grants.
The investigator grants in the aggregate amount of One Million Five Hundred Thousand Dollars ($1,500,000) provided under this Agreement are payable upon acceptance of manuscripts for publication in peer-reviewed journals, in accordance with the payment schedule set forth in Exhibit D. For the avoidance of doubt, the payment of such grants is contingent solely upon the acceptance of the manuscript for publication and is independent of the Review Period and Patent Delay Period set forth in this Section. The availability of the investigator grants shall not be conditioned upon the Investigator's acceptance of Sponsor's comments during the Review Period, nor shall the grants constitute a mechanism for Sponsor to exercise control over the scientific content of any Proposed Publication.
7. Relationship to Other MCTA Provisions
The publication rights framework proposed above must be read in conjunction with several other provisions of the MCTA. For completeness, and to assist your review, we summarize the key interrelationships as follows:
Exhibit F — Confidentiality and Data Protection Provisions. Exhibit F establishes a ten (10)-year confidentiality term covering all Protocol-related information exchanged between the parties. The publication rights provisions cross-reference Exhibit F to ensure that any Proposed Publication is reviewed for Confidential Information prior to submission. The confidentiality provisions also include carve-outs for disclosures to Institutional Review Boards (IRBs), Data Safety Monitoring Boards (DSMBs), and regulatory authorities, which are unaffected by the publication review process.
Exhibit G — Intellectual Property Provisions. In addition to the publication rights provisions set forth above, Exhibit G addresses Penterra's exclusive ownership of all clinical trial data generated in connection with the CLARION trial and the retention by each party of its pre-existing intellectual property. Joint inventions arising from the CLARION trial are governed by the IP Side Letter, which is being negotiated concurrently with the MCTA. The publication review and Patent Delay Period provisions are designed to protect the patent rights addressed in the IP Side Letter, and the final language of both documents must be harmonized to ensure consistency.
Exhibit H — Regulatory Compliance Representations. Exhibit H contains the parties' representations and warranties regarding regulatory compliance, including financial disclosure obligations under 21 C.F.R. Part 54 and reporting obligations under the Physician Payments Sunshine Act (Section 6002 of the Affordable Care Act) and the Centers for Medicare & Medicaid Services Open Payments program. The investigator publication grants described in Section __.08 above may constitute "transfers of value" reportable under the Sunshine Act, and the publication rights provisions should be reviewed in conjunction with Exhibit H to ensure that all reporting obligations are properly addressed.
Exhibit I — Form of Investigator Undertaking. Each investigator participating in the CLARION trial will execute an Investigator Undertaking in the form attached to the MCTA as Exhibit I, in which the investigator agrees to comply with, among other things, the publication provisions set forth in Exhibit G. The Investigator Undertaking serves as the contractual mechanism by which the publication review and delay provisions are made binding on individual investigators, and the language of the Investigator Undertaking must be updated to reflect the agreed publication rights framework.
Site Record Retention. The MCTA requires that participating sites retain source documents, case report forms, and related study records for a minimum period of fifteen (15) years following the completion of the CLARION trial. This record retention obligation supports the long-term integrity of the published data and provides a basis for verification of published results in the event of regulatory inquiry or scientific audit.
Penterra wishes to emphasize a point of principle that informs all of these provisions: data ownership and publication rights are distinct concepts. Under the MCTA, Penterra retains exclusive ownership of all clinical trial data. Publication rights, as set forth in the proposed language, constitute a license granted to the investigators — a license that is broad, well-defined, and subject only to the limited review and delay provisions described above. The publication review framework protects both Penterra's ownership interest in the data and the investigators' licensed right to publish, and we believe the proposed language strikes an appropriate and commercially reasonable balance between these interests.
8. Request for Response and Next Steps
We respectfully request that Veridian and your firm review the foregoing proposal and provide a written response by no later than May 30, 2023. Our objective is to reach agreement on the publication rights language in sufficient time for it to be incorporated into the Second Draft MCTA, which is currently being finalized for circulation. To the extent that Veridian has specific comments, counterproposals, or concerns regarding any aspect of the proposal set forth in this letter, we would welcome the opportunity to discuss them either by telephone or in a meeting at your convenience.
We are mindful that the parties continue to have open items on several other provisions of the MCTA, including but not limited to subject-injury indemnification and liability allocation, insurance requirements and limits, payment milestones and invoicing procedures, and protocol-deviation liability. We believe the publication rights issue can and should be resolved in parallel with these other matters, and we encourage both sides to proceed on all fronts simultaneously so as not to introduce unnecessary delay into the overall negotiation timeline.
As you know, the parties have agreed to a target signing date that is driven in significant part by the need to have the MCTA fully executed and in place well in advance of the target first patient in date of August 14, 2023. We are committed to meeting that timeline and would appreciate Veridian's cooperation in ensuring that the publication rights issue — which we believe is close to resolution — does not become a gating item.
Finally, should it be helpful or necessary to address the publication rights issue (along with any remaining open items) in a broader in-person negotiation session, we are prepared to travel to your Philadelphia office for that purpose. We understand that such a session may be scheduled for early June; should that come to pass, we would suggest June 9, 2023, as a potential date, and we would be pleased to include the publication rights discussion on the agenda for that meeting.
We wish to express our sincere appreciation for the collaborative and professional approach that Veridian and your firm have brought to this negotiation. The CLARION trial represents a significant opportunity for both Penterra and Veridian, and we are confident that the parties can arrive at a publication rights framework that fully supports investigator academic freedom while also protecting the legitimate interests of the sponsor. Penterra remains firmly committed to that objective, and we look forward to your response.
Sincerely,
CALDERWOOD & HARKNESS LLP
By: ________
Miriam Calloway Partner, Healthcare & Life Sciences Practice Group 280 Park Avenue, 34th Floor New York, New York 10017 Telephone: (212) 554-7036
Email: mcalloway@calderwoodharkness.com
cc: (via email)
Nathaniel Briggs, Esq. — Vice President & General Counsel, Penterra Pharmaceuticals Corp.
Rebecca Liang, Esq. — Associate General Counsel, Clinical Affairs, Penterra Pharmaceuticals Corp.
Joel Strauss, Esq. — Partner, Calderwood & Harkness LLP
Sean Morrissey, Esq. — Associate, Calderwood & Harkness LLP
Christopher Aiken, Esq. — Associate, Calderwood & Harkness LLP
David Kesselman, Esq. — Associate, Whitmore, Jansen & Callahan LLP
Enclosure:
Proposed Revised Language for Exhibit G, Section __ (Publication Rights) — Master Clinical Trial Agreement between Penterra Pharmaceuticals Corp. and Veridian Health Research Network, Inc. (Protocol PPC-4871-III / CLARION)

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