1018-00008 · Penterra Pharmaceuticals Corp · Interim Period

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PRIVILEGED AND CONFIDENTIAL

CALDERWOOD & HARKNESS LLP 200 Park Avenue, 42nd Floor New York, New York 10166

Telephone: (212) 558-4000 Facsimile: (212) 558-3588

www.calderwoodharkness.com

Oliver Mackenzie Partner Direct Dial: (212) 558-4127

Email: omackenzie@calderwoodharkness.com

August 30, 2024

Via Email (rwhitmore@lathamarcher.com) and Overnight Courier

Rebecca Whitmore, Esq. Partner Zalcourt Archer & Cole LLP One Federal Street, 30th Floor Boston, Massachusetts 02110

Re: Stock Purchase Agreement dated June 10, 2024 among Penterra Pharmaceuticals Corp., Veridian Biosciences, Inc., the Sellers named therein, and David Ng as Stockholder Representative — Veridian Protocol Amendment (VRD-4187 / Protocol v4.0) and Compliance with Interim Operating Covenants

Dear Ms. Whitmore:

I. Identification of Representation and Purpose

We represent Penterra Pharmaceuticals Corp. ("Penterra" or the "Buyer") in connection with that certain Stock Purchase Agreement dated as of June 10, 2024 (as may be amended, supplemented, or otherwise modified from time to time, the "Agreement" or "SPA"), by and among Penterra, Veridian Biosciences, Inc. (the "Company" or "Veridian"), the Sellers identified on Annex A thereto, and David Ng, in his capacity as Stockholder Representative (the "Stockholder Representative"). Capitalized terms used but not otherwise defined in this letter shall have the meanings ascribed to them in the SPA.

The purpose of this letter is to address Veridian's recent implementation of Protocol Amendment v4.0 to the Marlowe Asset Management-2 clinical trial protocol for the Company's lead product candidate, VRD-4187, and to formally request information and documentation regarding whether the prior written consent of Penterra was required under Section 5.1 of the SPA before Veridian undertook such actions. As described in greater detail below, Penterra has substantial concerns that Veridian's implementation of Protocol Amendment v4.0 without Penterra's prior written consent may constitute a breach of the Company's obligations under the interim operating covenants set forth in the SPA. Penterra reserves all of its rights and remedies in connection with these matters.

This correspondence is submitted in connection with Calderwood & Harkness Matter Number 1018-00008.

II. Background — Factual Recitation of Recent Events

We set forth below our understanding of the relevant factual chronology, based upon information currently available to Penterra. Penterra reserves the right to supplement or modify this factual recitation as additional information becomes available, and nothing herein shall be construed as an admission or acknowledgment that the facts set forth below are complete or that any characterization offered by Veridian in prior or subsequent communications is accurate.

A. Marlowe Asset Management-2 DMC Interim Analysis (August 14, 2024)

On August 14, 2024, the independent Data Monitoring Committee (the "DMC") for the Marlowe Asset Management-2 clinical trial conducted a pre-specified interim analysis of safety and efficacy data. Marlowe Asset Management-2 is a randomized, open-label Phase II clinical trial (ClinicalTrials.gov Identifier: NCT05837291) evaluating VRD-4187 — a bispecific T-cell engager targeting delta-like ligand 3 ("DLL3")-expressing tumors — in patients with extensive-stage small cell lung cancer ("ES-SCLC"). As of the date of the interim analysis, the Marlowe Asset Management-2 trial had enrolled a total of 387 patients across 42 clinical sites in the United States and European Union, with 194 patients randomized to the VRD-4187 treatment arm and 193 patients randomized to the standard-of-care control arm.

Following its review of the interim data, the DMC recommended the suspension of new patient enrollment and dose modification in the VRD-4187 treatment arm based on a concerning safety signal that had emerged from the accumulated data. The specific nature and scope of the DMC's recommendations are discussed further below.

B. Notification Under SPA § 5.1(b) (August 16, 2024)

On August 16, 2024 — two days after the DMC interim analysis — Penterra received notification from Veridian regarding certain of the DMC's interim analysis findings. This notification was delivered purportedly pursuant to Section 5.1(b) of the SPA, which governs the Company's obligation to provide prompt notification to the Buyer of material developments during the interim period between the signing and closing of the transaction.

Penterra notes, and expressly reserves all rights with respect to, the timeliness and completeness of this notification. The DMC analysis occurred on August 14, 2024, but the corresponding notification was not received by Penterra until August 16, 2024 — a gap of approximately forty-eight hours. Penterra has not yet had the opportunity to fully evaluate whether the substance of the notification complied with the requirements of Section 5.1(b) in all respects, and Penterra does not, by virtue of having received such notification, concede that the notice was timely, complete, or otherwise in compliance with the SPA.

C. Key Adverse Clinical Findings

Based on the information provided to Penterra, together with Penterra's own independent analysis, the interim data from the Marlowe Asset Management-2 trial revealed the following significant adverse findings:

(i) Grade ≥3 Cytokine Release Syndrome ("CRS") Incidence. The incidence of Grade 3 or higher CRS events in the VRD-4187 treatment arm was 23.4% (approximately 45 of 194 patients), compared with 4.1% (approximately 8 of 193 patients) in the control arm. This represents a difference of 19.3 percentage points — a clinically meaningful and statistically significant excess of severe CRS events attributable to VRD-4187 treatment.

(ii) Treatment-Related Deaths. There were 7 treatment-related deaths in the VRD-4187 arm (representing 3.6% of the 194 patients enrolled in that arm), compared with 1 treatment-related death in the control arm (representing 0.5% of the 193 patients enrolled in that arm). The magnitude of this treatment-related mortality differential is particularly concerning in the context of a Phase II trial in which the treatment arm did not demonstrate a statistically significant improvement in efficacy over the control arm.

(iii) Overall Response Rate ("ORR"). The ORR in the VRD-4187 treatment arm was 31.4%, compared with 28.9% in the control arm. The difference of 2.5 percentage points was not statistically significant (p = 0.58), indicating that VRD-4187 did not demonstrate a clinically or statistically meaningful improvement in tumor response relative to standard of care, notwithstanding the substantially elevated safety risk profile.

These findings were the subject of a detailed supplemental clinical assessment prepared by Broadleaf Scientific Consulting LLC ("Broadleaf"), Penterra's clinical due diligence advisor, which was delivered to Penterra on August 19, 2024. The Broadleaf assessment characterized the interim safety profile as "markedly unfavorable" and raised significant questions regarding the continued viability of the current development pathway for VRD-4187.

D. FDA Partial Clinical Hold (August 22, 2024)

On August 22, 2024, the United States Food and Drug Administration (the "FDA") imposed a partial clinical hold on VRD-4187 under Investigational New Drug Application No. 154832 ("IND 154832"), pending further investigation of the CRS-related deaths. As Penterra understands the partial clinical hold, its terms prohibit the enrollment of new patients in the Marlowe Asset Management-2 trial and impose certain restrictions on ongoing dosing of currently enrolled patients, pending FDA review of additional safety information and an adequate response from Veridian as the IND sponsor.

The imposition of a partial clinical hold by the FDA is a significant regulatory action that carries material implications for the timeline, cost, regulatory pathway, and ultimate approvability of VRD-4187. Penterra notes that the FDA's partial clinical hold is itself an event of the type that Section 5.1(b) of the SPA requires to be promptly reported to the Buyer, and Penterra reserves all rights regarding the timeliness and adequacy of any notification provided by Veridian in connection therewith.

E. Protocol Amendment v4.0 (August 28, 2024)

Penterra understands that on or about August 28, 2024, Veridian implemented Protocol Amendment v4.0 to the Marlowe Asset Management-2 trial protocol for VRD-4187 (hereinafter, "Protocol v4.0" or the "Protocol Amendment"). Based on the limited information currently available to Penterra, Protocol v4.0 reportedly includes the following substantive modifications to the Marlowe Asset Management-2 trial design:

(i) Mandatory Tocilizumab Prophylaxis. Protocol v4.0 introduces mandatory prophylactic administration of tocilizumab (an interleukin-6 receptor antagonist) for all patients receiving VRD-4187 in the treatment arm of the Marlowe Asset Management-2 trial. This represents the addition of a new mandatory concomitant medication to the trial protocol — a measure that was not part of the original protocol or any prior amendment, and that may materially affect the interpretation of both safety and efficacy data from the trial.

(ii) Dose Reduction of VRD-4187. Protocol v4.0 reduces the starting dose of VRD-4187 from 1.5 mg/kg to 0.75 mg/kg — a 50% reduction in the initial dose level. A change of this magnitude to the dosing regimen of the study drug is a fundamental alteration to the trial's clinical design, with potentially far-reaching consequences for efficacy outcomes, pharmacokinetic and pharmacodynamic exposure parameters, dose-response characterization, and the regulatory evaluation of the benefit-risk profile of VRD-4187.

Critically, Protocol Amendment v4.0 was implemented by Veridian without Penterra's prior written consent. At no point prior to August 28, 2024 did Veridian, the Stockholder Representative, or Zalcourt Archer & Cole LLP contact Penterra or Calderwood & Harkness LLP to request Penterra's consent to the Protocol Amendment or to discuss whether such consent was required under Section 5.1(a) of the SPA.

III. Applicable SPA Provisions — Interim Operating Covenants (Section 5.1)

We set forth below the provisions of the SPA that are directly relevant to the matters raised in this letter. Penterra does not, by identifying these specific provisions, limit its rights to invoke any other provision of the SPA or applicable law.

A. General Covenant to Operate in Ordinary Course

Section 5.1(a) of the SPA provides, in pertinent part:

"During the period from the date of this Agreement until the earlier of (x) the Closing and (y) the termination of this Agreement in accordance with its terms (the "Interim Period"), except as set forth on Schedule 5.1(a) or as otherwise expressly contemplated by this Agreement, the Company shall (i) conduct its business in the ordinary course of business consistent with past practice in all material respects, and (ii) use commercially reasonable efforts to preserve intact its business organization, keep available the services of its current officers and key employees, and maintain satisfactory relationships with licensors, licensees, clinical investigators, regulatory authorities, and other Persons having material business relationships with the Company."

This general covenant establishes a baseline obligation requiring the Company to maintain the status quo of its business operations during the Interim Period and to refrain from actions that deviate from the ordinary course of business as historically conducted by the Company.

B. Specific Restrictions Requiring Buyer's Prior Written Consent

Section 5.1(a) further provides that, without limiting the generality of the foregoing covenant, during the Interim Period the Company shall not take any of a number of specifically enumerated actions without the prior written consent of the Buyer (such consent not to be unreasonably withheld, conditioned, or delayed). The restrictions that are directly relevant to the matters at hand include, without limitation:

(i) Material modifications to clinical trial protocols or clinical development plans for any product candidate, including without limitation VRD-4187 (Section 5.1(a)(viii));

(ii) Entry into, amendment, modification, waiver, or termination of any Material Contract, or any agreement that, if in effect as of the date of this Agreement, would have been required to be disclosed as a Material Contract pursuant to Section 3.14 (Section 5.1(a)(xii));

(iii) Changes to the Company's regulatory strategy with respect to any product candidate under active Investigational New Drug application with the FDA or any comparable regulatory filing with any other Governmental Authority (Section 5.1(a)(ix));

(iv) Any action or failure to act that would reasonably be expected to delay or prevent the satisfaction of any condition to the Closing set forth in Article VII, or that would reasonably be expected to result in a breach of any representation, warranty, covenant, or agreement of the Company set forth in this Agreement (Section 5.1(a)(xxi)).

Each of the foregoing restrictions operates as an independent constraint on the Company's conduct during the Interim Period, and each requires the Buyer's prior written consent before the Company may undertake the restricted action. As discussed in Section IV below, Penterra believes that Protocol Amendment v4.0 implicates multiple of these restrictions.

C. Notification Obligations Under Section 5.1(b)

In addition to the consent-based restrictions described above, Section 5.1(b) of the SPA separately imposes affirmative notification obligations on the Company. Section 5.1(b) requires, in relevant part, that the Company promptly notify the Buyer in writing of:

(i) any material adverse development in the Company's business, operations, financial condition, or results of operations;

(ii) any communication from the FDA or any other Governmental Authority concerning any product candidate of the Company, including without limitation any Clinical Hold, Warning Letter, Form 483, or similar regulatory action;

(iii) any material adverse event, serious adverse event, or suspected unexpected serious adverse reaction occurring in any clinical trial sponsored or conducted by the Company; and

(iv) any event, development, condition, or occurrence that would reasonably be expected to cause any condition to the Closing set forth in Article VII not to be satisfied.

These notification obligations operate independently of, and in addition to, the consent requirements described in Section III.B above. The obligation to notify does not relieve the Company of the obligation to obtain prior written consent where consent is independently required, and the provision of notice (even if timely) does not substitute for consent.

IV. Penterra's Specific Concerns Regarding Consent

A. Protocol v4.0 Constitutes a Material Modification to a Clinical Trial Protocol

Penterra's primary concern is straightforward: the implementation of Protocol v4.0 constitutes a "material modification to [a] clinical trial protocol" for VRD-4187 within the plain meaning of Section 5.1(a)(viii) of the SPA, and accordingly required Penterra's prior written consent before it could be implemented.

Protocol v4.0 fundamentally alters the dosing regimen of VRD-4187 by reducing the starting dose by 50% — from 1.5 mg/kg to 0.75 mg/kg — and introduces mandatory tocilizumab prophylaxis for all patients in the treatment arm. These are not minor administrative or clerical amendments to the clinical trial protocol. They represent substantive, consequential changes to the very core of the drug candidate's clinical development program, with potentially far-reaching implications, including but not limited to:

(a) Efficacy Data. A 50% reduction in starting dose may materially affect the efficacy outcomes observed in the Marlowe Asset Management-2 trial. VRD-4187 was designed and developed based on a dose-response relationship that, as reflected in the Phase I dose-escalation data, was believed to support the 1.5 mg/kg starting dose. A halving of that dose may result in sub-therapeutic drug exposure for some or all patients, potentially rendering the trial incapable of demonstrating a statistically significant efficacy signal — which, in turn, may fundamentally compromise the development program for VRD-4187.

(b) Trial Timeline. The protocol amendment, together with the partial clinical hold, may necessitate a substantial extension of the trial timeline. The need to re-establish dose-response data at the lower dose level, the potential for additional enrollment cohorts, and the requirement for additional FDA interactions all contribute to the likelihood of material delays in trial completion and data readout.

(c) Regulatory Review Pathway. The dose reduction and addition of mandatory concomitant medication may alter the benefit-risk profile that the FDA is evaluating under IND 154832. The FDA may require supplemental safety analyses, revised statistical analysis plans, additional pharmacovigilance reporting, or new or amended clinical endpoints, any of which could materially change the regulatory pathway and timeline for VRD-4187.

(d) Commercial Viability and Approvability. The cumulative effect of the foregoing may materially diminish the ultimate commercial viability and probability of regulatory approval of VRD-4187 — the very asset that formed the core of the value proposition underlying the transaction contemplated by the SPA.

Under any reasonable interpretation of the SPA, changes of this nature and magnitude to the Marlowe Asset Management-2 trial protocol constitute "material modifications" that required Penterra's prior written consent.

B. Potential Impact on Regulatory Strategy and IND Status

Beyond the specific restriction on material protocol modifications, Protocol v4.0 also implicates the separate restriction in Section 5.1(a)(ix) on changes to the Company's regulatory strategy for any product candidate under an active IND. The dose reduction from 1.5 mg/kg to 0.75 mg/kg is not merely a clinical adjustment — it has direct regulatory implications. The revised dosing regimen alters the benefit-risk profile being evaluated by the FDA under IND 154832, and it may necessitate additional FDA interactions that go beyond routine trial management.

Specifically, Penterra is concerned that the Protocol Amendment may require or precipitate one or more of the following regulatory consequences: (i) a formal Type A or Type B meeting with the FDA to discuss the revised development strategy; (ii) supplemental safety analyses and revised Investigator's Brochure submissions; (iii) revised clinical endpoints or statistical analysis plans; (iv) additional pharmacokinetic and pharmacodynamic analyses to support the revised dose level; and (v) potential reclassification of the development program from the current regulatory pathway to a more extended pathway, including the potential need for additional clinical studies before Veridian could support a Biologics License Application filing. Each of these consequences represents a change to the Company's regulatory strategy that falls within the scope of Section 5.1(a)(ix) of the SPA.

C. No Prior Written Consent Was Sought or Obtained

Penterra emphasizes that the concern raised in this letter is not merely one of substance — it is also one of process. Penterra did not receive any request from Veridian, from the Stockholder Representative, or from Zalcourt Archer & Cole LLP for Penterra's prior written consent before Veridian implemented Protocol v4.0 on or about August 28, 2024. There was no communication — written, oral, or otherwise — in which the Company sought to engage with the Buyer regarding the proposed protocol amendment prior to its implementation. No draft of the Protocol Amendment was shared with Penterra for review. No analysis was provided regarding the expected impact on clinical endpoints, trial timelines, or the regulatory pathway. The consent mechanism contemplated by Section 5.1(a) was entirely circumvented.

The failure to seek the Buyer's consent before taking such a material action during the Interim Period raises serious and substantial concerns regarding Veridian's compliance with its obligations under Section 5.1(a) of the SPA. These concerns are compounded by the fact that the SPA's consent provisions expressly require that the Buyer's consent "not be unreasonably withheld, conditioned, or delayed" — a standard that contemplates a cooperative process of information exchange and good-faith deliberation, not unilateral action followed by after-the-fact disclosure.

V. Formal Request for Information and Documentation

In light of the foregoing, Penterra, through undersigned counsel, hereby formally requests that Veridian promptly provide the following information and documentation. This request is made pursuant to Penterra's rights under the SPA (including, without limitation, Sections 5.1, 5.3, and 5.7 thereof) and applicable law:

A. Protocol v4.0 Documentation

(i) A complete, unredacted copy of Protocol Amendment v4.0 as submitted to all relevant Institutional Review Boards ("IRBs"), Ethics Committees, and regulatory authorities, including the FDA.

(ii) A complete copy of the original Marlowe Asset Management-2 protocol (i.e., the version in effect as of June 10, 2024, the date of the SPA) and all prior amendments thereto (Protocol Amendments v1.0 through v3.0, inclusive), to the extent such documents have not been previously provided to Penterra or were not included in the virtual data room established in connection with the SPA.

(iii) A redline comparison of Protocol Amendment v4.0 against the immediately prior protocol version (Protocol v3.0 or such other version as was in effect immediately prior to the adoption of Protocol v4.0), clearly identifying all additions, deletions, and modifications.

B. FDA Communications

(iv) All correspondence between Veridian — including, without limitation, Dr. Anne-Marie Fontaine, Vice President, Regulatory Affairs, or any other officer, employee, agent, or representative of Veridian — and the FDA regarding the partial clinical hold on IND 154832 imposed on August 22, 2024, including any FDA letters, information requests, meeting requests, meeting minutes, teleconference summaries, and Veridian's responses, submissions, or other communications in connection therewith.

(v) Any FDA feedback, guidance, or communications regarding Protocol Amendment v4.0, including any written or verbal acknowledgment, concurrence, or objection by the FDA to the Protocol Amendment, whether formal or informal.

(vi) Any FDA communications concerning VRD-4187 received by Veridian on or after August 14, 2024, to the extent not encompassed by clauses (iv) and (v) above.

C. Internal Decision-Making Materials

(vii) Minutes of any meetings of the Veridian Board of Directors, any committee thereof, or any internal decision-making body at which the decision to implement Protocol Amendment v4.0 was discussed, considered, or approved.

(viii) Internal memoranda, presentations, analyses, or other decision-making materials relating to Veridian's decision to implement Protocol v4.0, including any analysis of whether the Buyer's consent was required under Section 5.1(a) of the SPA before the Protocol Amendment could be adopted.

(ix) Any communications between Veridian's management (including, without limitation, its Chief Executive Officer, Chief Medical Officer, VP of Regulatory Affairs, and VP of Clinical Operations) and Veridian's outside legal counsel at Zalcourt Archer & Cole LLP regarding the consent requirement under Section 5.1(a) in connection with Protocol v4.0, to the extent such communications are not protected by the attorney-client privilege or to the extent Veridian elects to disclose such communications. To the extent Veridian asserts privilege over any such communications, Penterra requests that Veridian provide a privilege log identifying the date, author, recipient(s), and subject matter of each withheld communication.

D. Clinical and Scientific Rationale

(x) Any internal or external scientific analysis, clinical pharmacology assessment, or medical opinion supporting the specific dose reduction from 1.5 mg/kg to 0.75 mg/kg, including the basis for selecting 0.75 mg/kg (as opposed to any other dose level) as the revised starting dose.

(xi) Any analysis of the expected impact of the dose reduction on VRD-4187 efficacy endpoints, including the primary endpoint of overall response rate and any secondary or exploratory endpoints specified in the Marlowe Asset Management-2 protocol.

(xii) Any pharmacokinetic and pharmacodynamic modeling or simulation data supporting the revised 0.75 mg/kg dose, including any exposure-response analyses.

(xiii) The scientific and clinical rationale for the selection of mandatory tocilizumab prophylaxis (as opposed to other CRS mitigation strategies), including any analysis of the expected impact of tocilizumab co-administration on VRD-4187 efficacy (including any potential for interference with the T-cell engager mechanism of action).

E. Veridian's Legal Position

(xiv) Veridian's position as to whether the Buyer's prior written consent was required under Section 5.1(a) of the SPA before implementing Protocol Amendment v4.0, together with the contractual and factual basis for such position.

(xv) If Veridian takes the position that Protocol v4.0 falls within an exception to the consent requirement — including, by way of example, any contention that the Protocol Amendment was an action taken in response to a regulatory directive, an action reasonably necessary to protect patient safety, or an action within the ordinary course of business — Penterra requests a detailed statement of the specific contractual provision(s) and factual predicate(s) upon which any such exception is claimed to rest.

(xvi) Veridian's position regarding whether the implementation of Protocol v4.0 was discussed with or disclosed to the Stockholder Representative prior to implementation, and if so, the substance of any such discussion or disclosure.

VI. Reservation of Rights

Penterra expressly reserves all of its rights and remedies under the SPA, at law, and in equity, with respect to the matters addressed in this letter and any related matters, including without limitation:

(a) The right to assert that Protocol Amendment v4.0 was implemented in breach of Section 5.1(a) of the SPA due to the failure to obtain Penterra's prior written consent before undertaking a material modification to the Marlowe Asset Management-2 clinical trial protocol for VRD-4187.

(b) The right to assert that the implementation of Protocol v4.0 without the Buyer's consent constitutes a breach of the Company's interim operating covenants, which may independently affect the satisfaction of the closing conditions set forth in Article VII of the SPA, including without limitation the condition set forth in Section 7.2(a) (requiring that the representations and warranties of the Company and the Sellers be true and correct in all material respects as of the Closing Date) and Section 7.2(b) (requiring that the Company shall have performed and complied in all material respects with all covenants and agreements required to be performed or complied with by the Company prior to or at the Closing).

(c) The right to take any action permitted under the SPA, including but not limited to the exercise of termination rights under Section 8.1 of the SPA, should Penterra determine that the circumstances warrant such action.

(d) The right to assert that the adverse interim clinical trial data from the Marlowe Asset Management-2 DMC analysis, the FDA's imposition of a partial clinical hold on IND 154832, and/or Veridian's implementation of Protocol Amendment v4.0 — individually or in the aggregate — constitute, give rise to, or contribute to a "Material Adverse Effect" as defined in Section 1.1 of the SPA, and that such Material Adverse Effect may independently affect the satisfaction of closing conditions and/or give rise to termination rights or other remedies.

(e) Any and all other rights and remedies available to Penterra under the SPA, at law, or in equity, whether or not specifically identified herein.

Nothing in this letter, or in any response to this letter, shall constitute a waiver of any of Penterra's rights under the SPA or applicable law, whether or not such rights are specifically referenced herein. Penterra's election to request information and documentation in advance of making any formal determination regarding breach or the exercise of its remedies shall not be construed as a waiver of, or delay in, the exercise of any right or remedy. Furthermore, the delivery of any consent by Penterra, were such consent to be sought at this point, shall not be deemed to constitute a waiver or cure of the failure to have sought and obtained such consent prior to taking the action in question, nor shall it be deemed to prejudice any claim Penterra may have arising from such failure.

VII. Requested Response Timeline

Given the materiality of the matters addressed herein, the time-sensitive nature of the ongoing Interim Period obligations under the SPA, the pendency of the FDA partial clinical hold, and the potential implications of these matters for the satisfaction of closing conditions, Penterra respectfully requests that Veridian and Zalcourt Archer & Cole LLP provide the information and documentation requested in Section V above no later than September 6, 2024 (i.e., within five (5) business days of the date of this letter).

In addition, Penterra requests that a conference call be scheduled at Zalcourt Archer & Cole's earliest convenience — and in any event no later than September 4, 2024 — to discuss the matters raised in this letter and to facilitate an efficient exchange of information. Please direct all scheduling communications for such call to Megan Chu at Calderwood & Harkness LLP at the contact information set forth below.

Penterra's agreement to engage in discussions and its request for information shall not be construed as a waiver of any right or remedy, an extension of any deadline, or a commitment to refrain from exercising any right available under the SPA or applicable law during the pendency of such discussions.

VIII. Closing

We appreciate your prompt attention to this matter. Penterra remains committed to constructive engagement with Veridian and the Stockholder Representative, and we are available to discuss any of the matters raised herein at your convenience. However, as stated above, nothing in this letter or in any subsequent communication shall constitute a waiver of, or limitation on, any right or remedy of Penterra under the SPA, at law, or in equity.

Please do not hesitate to contact me or Megan Chu with any questions regarding this letter or to coordinate the scheduling of the conference call referenced above.

Very truly yours,

CALDERWOOD & HARKNESS LLP

By: ________

Oliver Mackenzie Partner

Telephone: (212) 558-4127

Email: omackenzie@calderwoodharkness.com

Contact Information for Scheduling:

Megan Chu, Associate Calderwood & Harkness LLP Telephone: (212) 558-4293

Email: mchu@calderwoodharkness.com

cc (via email):

Thomas F. Holbrook, Esq. General Counsel & Secretary Penterra Pharmaceuticals Corp. 1100 Meridian Boulevard, Suite 400 Princeton, New Jersey 08540

Natalie Reiner Senior Vice President, Corporate Development Penterra Pharmaceuticals Corp. 1100 Meridian Boulevard, Suite 400 Princeton, New Jersey 08540

Megan Chu, Esq. Associate Calderwood & Harkness LLP 200 Park Avenue, 42nd Floor New York, New York 10166

David Ng, Stockholder Representative c/o Crestline Ventures, LP (per notice provisions of the SPA, Section 10.2)

PRIVILEGED AND CONFIDENTIAL
CALDERWOOD & HARKNESS LLP 200 Park Avenue, 42nd Floor New York, New York 10166
Telephone: (212) 558-4000 Facsimile: (212) 558-3588
www.calderwoodharkness.com
Oliver Mackenzie Partner Direct Dial: (212) 558-4127
Email: omackenzie@calderwoodharkness.com
August 30, 2024
Via Email (rwhitmore@lathamarcher.com) and Overnight Courier
Rebecca Whitmore, Esq. Partner Zalcourt Archer & Cole LLP One Federal Street, 30th Floor Boston, Massachusetts 02110
Re: Stock Purchase Agreement dated June 10, 2024 among Penterra Pharmaceuticals Corp., Veridian Biosciences, Inc., the Sellers named therein, and David Ng as Stockholder Representative — Veridian Protocol Amendment (VRD-4187 / Protocol v4.0) and Compliance with Interim Operating Covenants
Dear Ms. Whitmore:
I. Identification of Representation and Purpose
We represent Penterra Pharmaceuticals Corp. ("Penterra" or the "Buyer") in connection with that certain Stock Purchase Agreement dated as of June 10, 2024 (as may be amended, supplemented, or otherwise modified from time to time, the "Agreement" or "SPA"), by and among Penterra, Veridian Biosciences, Inc. (the "Company" or "Veridian"), the Sellers identified on Annex A thereto, and David Ng, in his capacity as Stockholder Representative (the "Stockholder Representative"). Capitalized terms used but not otherwise defined in this letter shall have the meanings ascribed to them in the SPA.
The purpose of this letter is to address Veridian's recent implementation of Protocol Amendment v4.0 to the Marlowe Asset Management-2 clinical trial protocol for the Company's lead product candidate, VRD-4187, and to formally request information and documentation regarding whether the prior written consent of Penterra was required under Section 5.1 of the SPA before Veridian undertook such actions. As described in greater detail below, Penterra has substantial concerns that Veridian's implementation of Protocol Amendment v4.0 without Penterra's prior written consent may constitute a breach of the Company's obligations under the interim operating covenants set forth in the SPA. Penterra reserves all of its rights and remedies in connection with these matters.
This correspondence is submitted in connection with Calderwood & Harkness Matter Number 1018-00008.
II. Background — Factual Recitation of Recent Events
We set forth below our understanding of the relevant factual chronology, based upon information currently available to Penterra. Penterra reserves the right to supplement or modify this factual recitation as additional information becomes available, and nothing herein shall be construed as an admission or acknowledgment that the facts set forth below are complete or that any characterization offered by Veridian in prior or subsequent communications is accurate.
A. Marlowe Asset Management-2 DMC Interim Analysis (August 14, 2024)
On August 14, 2024, the independent Data Monitoring Committee (the "DMC") for the Marlowe Asset Management-2 clinical trial conducted a pre-specified interim analysis of safety and efficacy data. Marlowe Asset Management-2 is a randomized, open-label Phase II clinical trial (ClinicalTrials.gov Identifier: NCT05837291) evaluating VRD-4187 — a bispecific T-cell engager targeting delta-like ligand 3 ("DLL3")-expressing tumors — in patients with extensive-stage small cell lung cancer ("ES-SCLC"). As of the date of the interim analysis, the Marlowe Asset Management-2 trial had enrolled a total of 387 patients across 42 clinical sites in the United States and European Union, with 194 patients randomized to the VRD-4187 treatment arm and 193 patients randomized to the standard-of-care control arm.
Following its review of the interim data, the DMC recommended the suspension of new patient enrollment and dose modification in the VRD-4187 treatment arm based on a concerning safety signal that had emerged from the accumulated data. The specific nature and scope of the DMC's recommendations are discussed further below.
B. Notification Under SPA § 5.1(b) (August 16, 2024)
On August 16, 2024 — two days after the DMC interim analysis — Penterra received notification from Veridian regarding certain of the DMC's interim analysis findings. This notification was delivered purportedly pursuant to Section 5.1(b) of the SPA, which governs the Company's obligation to provide prompt notification to the Buyer of material developments during the interim period between the signing and closing of the transaction.
Penterra notes, and expressly reserves all rights with respect to, the timeliness and completeness of this notification. The DMC analysis occurred on August 14, 2024, but the corresponding notification was not received by Penterra until August 16, 2024 — a gap of approximately forty-eight hours. Penterra has not yet had the opportunity to fully evaluate whether the substance of the notification complied with the requirements of Section 5.1(b) in all respects, and Penterra does not, by virtue of having received such notification, concede that the notice was timely, complete, or otherwise in compliance with the SPA.
C. Key Adverse Clinical Findings
Based on the information provided to Penterra, together with Penterra's own independent analysis, the interim data from the Marlowe Asset Management-2 trial revealed the following significant adverse findings:
(i) Grade ≥3 Cytokine Release Syndrome ("CRS") Incidence. The incidence of Grade 3 or higher CRS events in the VRD-4187 treatment arm was 23.4% (approximately 45 of 194 patients), compared with 4.1% (approximately 8 of 193 patients) in the control arm. This represents a difference of 19.3 percentage points — a clinically meaningful and statistically significant excess of severe CRS events attributable to VRD-4187 treatment.
(ii) Treatment-Related Deaths. There were 7 treatment-related deaths in the VRD-4187 arm (representing 3.6% of the 194 patients enrolled in that arm), compared with 1 treatment-related death in the control arm (representing 0.5% of the 193 patients enrolled in that arm). The magnitude of this treatment-related mortality differential is particularly concerning in the context of a Phase II trial in which the treatment arm did not demonstrate a statistically significant improvement in efficacy over the control arm.
(iii) Overall Response Rate ("ORR"). The ORR in the VRD-4187 treatment arm was 31.4%, compared with 28.9% in the control arm. The difference of 2.5 percentage points was not statistically significant (p = 0.58), indicating that VRD-4187 did not demonstrate a clinically or statistically meaningful improvement in tumor response relative to standard of care, notwithstanding the substantially elevated safety risk profile.
These findings were the subject of a detailed supplemental clinical assessment prepared by Broadleaf Scientific Consulting LLC ("Broadleaf"), Penterra's clinical due diligence advisor, which was delivered to Penterra on August 19, 2024. The Broadleaf assessment characterized the interim safety profile as "markedly unfavorable" and raised significant questions regarding the continued viability of the current development pathway for VRD-4187.
D. FDA Partial Clinical Hold (August 22, 2024)
On August 22, 2024, the United States Food and Drug Administration (the "FDA") imposed a partial clinical hold on VRD-4187 under Investigational New Drug Application No. 154832 ("IND 154832"), pending further investigation of the CRS-related deaths. As Penterra understands the partial clinical hold, its terms prohibit the enrollment of new patients in the Marlowe Asset Management-2 trial and impose certain restrictions on ongoing dosing of currently enrolled patients, pending FDA review of additional safety information and an adequate response from Veridian as the IND sponsor.
The imposition of a partial clinical hold by the FDA is a significant regulatory action that carries material implications for the timeline, cost, regulatory pathway, and ultimate approvability of VRD-4187. Penterra notes that the FDA's partial clinical hold is itself an event of the type that Section 5.1(b) of the SPA requires to be promptly reported to the Buyer, and Penterra reserves all rights regarding the timeliness and adequacy of any notification provided by Veridian in connection therewith.
E. Protocol Amendment v4.0 (August 28, 2024)
Penterra understands that on or about August 28, 2024, Veridian implemented Protocol Amendment v4.0 to the Marlowe Asset Management-2 trial protocol for VRD-4187 (hereinafter, "Protocol v4.0" or the "Protocol Amendment"). Based on the limited information currently available to Penterra, Protocol v4.0 reportedly includes the following substantive modifications to the Marlowe Asset Management-2 trial design:
(i) Mandatory Tocilizumab Prophylaxis. Protocol v4.0 introduces mandatory prophylactic administration of tocilizumab (an interleukin-6 receptor antagonist) for all patients receiving VRD-4187 in the treatment arm of the Marlowe Asset Management-2 trial. This represents the addition of a new mandatory concomitant medication to the trial protocol — a measure that was not part of the original protocol or any prior amendment, and that may materially affect the interpretation of both safety and efficacy data from the trial.
(ii) Dose Reduction of VRD-4187. Protocol v4.0 reduces the starting dose of VRD-4187 from 1.5 mg/kg to 0.75 mg/kg — a 50% reduction in the initial dose level. A change of this magnitude to the dosing regimen of the study drug is a fundamental alteration to the trial's clinical design, with potentially far-reaching consequences for efficacy outcomes, pharmacokinetic and pharmacodynamic exposure parameters, dose-response characterization, and the regulatory evaluation of the benefit-risk profile of VRD-4187.
Critically, Protocol Amendment v4.0 was implemented by Veridian without Penterra's prior written consent. At no point prior to August 28, 2024 did Veridian, the Stockholder Representative, or Zalcourt Archer & Cole LLP contact Penterra or Calderwood & Harkness LLP to request Penterra's consent to the Protocol Amendment or to discuss whether such consent was required under Section 5.1(a) of the SPA.
III. Applicable SPA Provisions — Interim Operating Covenants (Section 5.1)
We set forth below the provisions of the SPA that are directly relevant to the matters raised in this letter. Penterra does not, by identifying these specific provisions, limit its rights to invoke any other provision of the SPA or applicable law.
A. General Covenant to Operate in Ordinary Course
Section 5.1(a) of the SPA provides, in pertinent part:
"During the period from the date of this Agreement until the earlier of (x) the Closing and (y) the termination of this Agreement in accordance with its terms (the "Interim Period"), except as set forth on Schedule 5.1(a) or as otherwise expressly contemplated by this Agreement, the Company shall (i) conduct its business in the ordinary course of business consistent with past practice in all material respects, and (ii) use commercially reasonable efforts to preserve intact its business organization, keep available the services of its current officers and key employees, and maintain satisfactory relationships with licensors, licensees, clinical investigators, regulatory authorities, and other Persons having material business relationships with the Company."
This general covenant establishes a baseline obligation requiring the Company to maintain the status quo of its business operations during the Interim Period and to refrain from actions that deviate from the ordinary course of business as historically conducted by the Company.
B. Specific Restrictions Requiring Buyer's Prior Written Consent
Section 5.1(a) further provides that, without limiting the generality of the foregoing covenant, during the Interim Period the Company shall not take any of a number of specifically enumerated actions without the prior written consent of the Buyer (such consent not to be unreasonably withheld, conditioned, or delayed). The restrictions that are directly relevant to the matters at hand include, without limitation:
(i) Material modifications to clinical trial protocols or clinical development plans for any product candidate, including without limitation VRD-4187 (Section 5.1(a)(viii));
(ii) Entry into, amendment, modification, waiver, or termination of any Material Contract, or any agreement that, if in effect as of the date of this Agreement, would have been required to be disclosed as a Material Contract pursuant to Section 3.14 (Section 5.1(a)(xii));
(iii) Changes to the Company's regulatory strategy with respect to any product candidate under active Investigational New Drug application with the FDA or any comparable regulatory filing with any other Governmental Authority (Section 5.1(a)(ix));
(iv) Any action or failure to act that would reasonably be expected to delay or prevent the satisfaction of any condition to the Closing set forth in Article VII, or that would reasonably be expected to result in a breach of any representation, warranty, covenant, or agreement of the Company set forth in this Agreement (Section 5.1(a)(xxi)).
Each of the foregoing restrictions operates as an independent constraint on the Company's conduct during the Interim Period, and each requires the Buyer's prior written consent before the Company may undertake the restricted action. As discussed in Section IV below, Penterra believes that Protocol Amendment v4.0 implicates multiple of these restrictions.
C. Notification Obligations Under Section 5.1(b)
In addition to the consent-based restrictions described above, Section 5.1(b) of the SPA separately imposes affirmative notification obligations on the Company. Section 5.1(b) requires, in relevant part, that the Company promptly notify the Buyer in writing of:
(i) any material adverse development in the Company's business, operations, financial condition, or results of operations;
(ii) any communication from the FDA or any other Governmental Authority concerning any product candidate of the Company, including without limitation any Clinical Hold, Warning Letter, Form 483, or similar regulatory action;
(iii) any material adverse event, serious adverse event, or suspected unexpected serious adverse reaction occurring in any clinical trial sponsored or conducted by the Company; and
(iv) any event, development, condition, or occurrence that would reasonably be expected to cause any condition to the Closing set forth in Article VII not to be satisfied.
These notification obligations operate independently of, and in addition to, the consent requirements described in Section III.B above. The obligation to notify does not relieve the Company of the obligation to obtain prior written consent where consent is independently required, and the provision of notice (even if timely) does not substitute for consent.
IV. Penterra's Specific Concerns Regarding Consent
A. Protocol v4.0 Constitutes a Material Modification to a Clinical Trial Protocol
Penterra's primary concern is straightforward: the implementation of Protocol v4.0 constitutes a "material modification to [a] clinical trial protocol" for VRD-4187 within the plain meaning of Section 5.1(a)(viii) of the SPA, and accordingly required Penterra's prior written consent before it could be implemented.
Protocol v4.0 fundamentally alters the dosing regimen of VRD-4187 by reducing the starting dose by 50% — from 1.5 mg/kg to 0.75 mg/kg — and introduces mandatory tocilizumab prophylaxis for all patients in the treatment arm. These are not minor administrative or clerical amendments to the clinical trial protocol. They represent substantive, consequential changes to the very core of the drug candidate's clinical development program, with potentially far-reaching implications, including but not limited to:
(a) Efficacy Data. A 50% reduction in starting dose may materially affect the efficacy outcomes observed in the Marlowe Asset Management-2 trial. VRD-4187 was designed and developed based on a dose-response relationship that, as reflected in the Phase I dose-escalation data, was believed to support the 1.5 mg/kg starting dose. A halving of that dose may result in sub-therapeutic drug exposure for some or all patients, potentially rendering the trial incapable of demonstrating a statistically significant efficacy signal — which, in turn, may fundamentally compromise the development program for VRD-4187.
(b) Trial Timeline. The protocol amendment, together with the partial clinical hold, may necessitate a substantial extension of the trial timeline. The need to re-establish dose-response data at the lower dose level, the potential for additional enrollment cohorts, and the requirement for additional FDA interactions all contribute to the likelihood of material delays in trial completion and data readout.
(c) Regulatory Review Pathway. The dose reduction and addition of mandatory concomitant medication may alter the benefit-risk profile that the FDA is evaluating under IND 154832. The FDA may require supplemental safety analyses, revised statistical analysis plans, additional pharmacovigilance reporting, or new or amended clinical endpoints, any of which could materially change the regulatory pathway and timeline for VRD-4187.
(d) Commercial Viability and Approvability. The cumulative effect of the foregoing may materially diminish the ultimate commercial viability and probability of regulatory approval of VRD-4187 — the very asset that formed the core of the value proposition underlying the transaction contemplated by the SPA.
Under any reasonable interpretation of the SPA, changes of this nature and magnitude to the Marlowe Asset Management-2 trial protocol constitute "material modifications" that required Penterra's prior written consent.
B. Potential Impact on Regulatory Strategy and IND Status
Beyond the specific restriction on material protocol modifications, Protocol v4.0 also implicates the separate restriction in Section 5.1(a)(ix) on changes to the Company's regulatory strategy for any product candidate under an active IND. The dose reduction from 1.5 mg/kg to 0.75 mg/kg is not merely a clinical adjustment — it has direct regulatory implications. The revised dosing regimen alters the benefit-risk profile being evaluated by the FDA under IND 154832, and it may necessitate additional FDA interactions that go beyond routine trial management.
Specifically, Penterra is concerned that the Protocol Amendment may require or precipitate one or more of the following regulatory consequences: (i) a formal Type A or Type B meeting with the FDA to discuss the revised development strategy; (ii) supplemental safety analyses and revised Investigator's Brochure submissions; (iii) revised clinical endpoints or statistical analysis plans; (iv) additional pharmacokinetic and pharmacodynamic analyses to support the revised dose level; and (v) potential reclassification of the development program from the current regulatory pathway to a more extended pathway, including the potential need for additional clinical studies before Veridian could support a Biologics License Application filing. Each of these consequences represents a change to the Company's regulatory strategy that falls within the scope of Section 5.1(a)(ix) of the SPA.
C. No Prior Written Consent Was Sought or Obtained
Penterra emphasizes that the concern raised in this letter is not merely one of substance — it is also one of process. Penterra did not receive any request from Veridian, from the Stockholder Representative, or from Zalcourt Archer & Cole LLP for Penterra's prior written consent before Veridian implemented Protocol v4.0 on or about August 28, 2024. There was no communication — written, oral, or otherwise — in which the Company sought to engage with the Buyer regarding the proposed protocol amendment prior to its implementation. No draft of the Protocol Amendment was shared with Penterra for review. No analysis was provided regarding the expected impact on clinical endpoints, trial timelines, or the regulatory pathway. The consent mechanism contemplated by Section 5.1(a) was entirely circumvented.
The failure to seek the Buyer's consent before taking such a material action during the Interim Period raises serious and substantial concerns regarding Veridian's compliance with its obligations under Section 5.1(a) of the SPA. These concerns are compounded by the fact that the SPA's consent provisions expressly require that the Buyer's consent "not be unreasonably withheld, conditioned, or delayed" — a standard that contemplates a cooperative process of information exchange and good-faith deliberation, not unilateral action followed by after-the-fact disclosure.
V. Formal Request for Information and Documentation
In light of the foregoing, Penterra, through undersigned counsel, hereby formally requests that Veridian promptly provide the following information and documentation. This request is made pursuant to Penterra's rights under the SPA (including, without limitation, Sections 5.1, 5.3, and 5.7 thereof) and applicable law:
A. Protocol v4.0 Documentation
(i) A complete, unredacted copy of Protocol Amendment v4.0 as submitted to all relevant Institutional Review Boards ("IRBs"), Ethics Committees, and regulatory authorities, including the FDA.
(ii) A complete copy of the original Marlowe Asset Management-2 protocol (i.e., the version in effect as of June 10, 2024, the date of the SPA) and all prior amendments thereto (Protocol Amendments v1.0 through v3.0, inclusive), to the extent such documents have not been previously provided to Penterra or were not included in the virtual data room established in connection with the SPA.
(iii) A redline comparison of Protocol Amendment v4.0 against the immediately prior protocol version (Protocol v3.0 or such other version as was in effect immediately prior to the adoption of Protocol v4.0), clearly identifying all additions, deletions, and modifications.
B. FDA Communications
(iv) All correspondence between Veridian — including, without limitation, Dr. Anne-Marie Fontaine, Vice President, Regulatory Affairs, or any other officer, employee, agent, or representative of Veridian — and the FDA regarding the partial clinical hold on IND 154832 imposed on August 22, 2024, including any FDA letters, information requests, meeting requests, meeting minutes, teleconference summaries, and Veridian's responses, submissions, or other communications in connection therewith.
(v) Any FDA feedback, guidance, or communications regarding Protocol Amendment v4.0, including any written or verbal acknowledgment, concurrence, or objection by the FDA to the Protocol Amendment, whether formal or informal.
(vi) Any FDA communications concerning VRD-4187 received by Veridian on or after August 14, 2024, to the extent not encompassed by clauses (iv) and (v) above.
C. Internal Decision-Making Materials
(vii) Minutes of any meetings of the Veridian Board of Directors, any committee thereof, or any internal decision-making body at which the decision to implement Protocol Amendment v4.0 was discussed, considered, or approved.
(viii) Internal memoranda, presentations, analyses, or other decision-making materials relating to Veridian's decision to implement Protocol v4.0, including any analysis of whether the Buyer's consent was required under Section 5.1(a) of the SPA before the Protocol Amendment could be adopted.
(ix) Any communications between Veridian's management (including, without limitation, its Chief Executive Officer, Chief Medical Officer, VP of Regulatory Affairs, and VP of Clinical Operations) and Veridian's outside legal counsel at Zalcourt Archer & Cole LLP regarding the consent requirement under Section 5.1(a) in connection with Protocol v4.0, to the extent such communications are not protected by the attorney-client privilege or to the extent Veridian elects to disclose such communications. To the extent Veridian asserts privilege over any such communications, Penterra requests that Veridian provide a privilege log identifying the date, author, recipient(s), and subject matter of each withheld communication.
D. Clinical and Scientific Rationale
(x) Any internal or external scientific analysis, clinical pharmacology assessment, or medical opinion supporting the specific dose reduction from 1.5 mg/kg to 0.75 mg/kg, including the basis for selecting 0.75 mg/kg (as opposed to any other dose level) as the revised starting dose.
(xi) Any analysis of the expected impact of the dose reduction on VRD-4187 efficacy endpoints, including the primary endpoint of overall response rate and any secondary or exploratory endpoints specified in the Marlowe Asset Management-2 protocol.
(xii) Any pharmacokinetic and pharmacodynamic modeling or simulation data supporting the revised 0.75 mg/kg dose, including any exposure-response analyses.
(xiii) The scientific and clinical rationale for the selection of mandatory tocilizumab prophylaxis (as opposed to other CRS mitigation strategies), including any analysis of the expected impact of tocilizumab co-administration on VRD-4187 efficacy (including any potential for interference with the T-cell engager mechanism of action).
E. Veridian's Legal Position
(xiv) Veridian's position as to whether the Buyer's prior written consent was required under Section 5.1(a) of the SPA before implementing Protocol Amendment v4.0, together with the contractual and factual basis for such position.
(xv) If Veridian takes the position that Protocol v4.0 falls within an exception to the consent requirement — including, by way of example, any contention that the Protocol Amendment was an action taken in response to a regulatory directive, an action reasonably necessary to protect patient safety, or an action within the ordinary course of business — Penterra requests a detailed statement of the specific contractual provision(s) and factual predicate(s) upon which any such exception is claimed to rest.
(xvi) Veridian's position regarding whether the implementation of Protocol v4.0 was discussed with or disclosed to the Stockholder Representative prior to implementation, and if so, the substance of any such discussion or disclosure.
VI. Reservation of Rights
Penterra expressly reserves all of its rights and remedies under the SPA, at law, and in equity, with respect to the matters addressed in this letter and any related matters, including without limitation:
(a) The right to assert that Protocol Amendment v4.0 was implemented in breach of Section 5.1(a) of the SPA due to the failure to obtain Penterra's prior written consent before undertaking a material modification to the Marlowe Asset Management-2 clinical trial protocol for VRD-4187.
(b) The right to assert that the implementation of Protocol v4.0 without the Buyer's consent constitutes a breach of the Company's interim operating covenants, which may independently affect the satisfaction of the closing conditions set forth in Article VII of the SPA, including without limitation the condition set forth in Section 7.2(a) (requiring that the representations and warranties of the Company and the Sellers be true and correct in all material respects as of the Closing Date) and Section 7.2(b) (requiring that the Company shall have performed and complied in all material respects with all covenants and agreements required to be performed or complied with by the Company prior to or at the Closing).
(c) The right to take any action permitted under the SPA, including but not limited to the exercise of termination rights under Section 8.1 of the SPA, should Penterra determine that the circumstances warrant such action.
(d) The right to assert that the adverse interim clinical trial data from the Marlowe Asset Management-2 DMC analysis, the FDA's imposition of a partial clinical hold on IND 154832, and/or Veridian's implementation of Protocol Amendment v4.0 — individually or in the aggregate — constitute, give rise to, or contribute to a "Material Adverse Effect" as defined in Section 1.1 of the SPA, and that such Material Adverse Effect may independently affect the satisfaction of closing conditions and/or give rise to termination rights or other remedies.
(e) Any and all other rights and remedies available to Penterra under the SPA, at law, or in equity, whether or not specifically identified herein.
Nothing in this letter, or in any response to this letter, shall constitute a waiver of any of Penterra's rights under the SPA or applicable law, whether or not such rights are specifically referenced herein. Penterra's election to request information and documentation in advance of making any formal determination regarding breach or the exercise of its remedies shall not be construed as a waiver of, or delay in, the exercise of any right or remedy. Furthermore, the delivery of any consent by Penterra, were such consent to be sought at this point, shall not be deemed to constitute a waiver or cure of the failure to have sought and obtained such consent prior to taking the action in question, nor shall it be deemed to prejudice any claim Penterra may have arising from such failure.
VII. Requested Response Timeline
Given the materiality of the matters addressed herein, the time-sensitive nature of the ongoing Interim Period obligations under the SPA, the pendency of the FDA partial clinical hold, and the potential implications of these matters for the satisfaction of closing conditions, Penterra respectfully requests that Veridian and Zalcourt Archer & Cole LLP provide the information and documentation requested in Section V above no later than September 6, 2024 (i.e., within five (5) business days of the date of this letter).
In addition, Penterra requests that a conference call be scheduled at Zalcourt Archer & Cole's earliest convenience — and in any event no later than September 4, 2024 — to discuss the matters raised in this letter and to facilitate an efficient exchange of information. Please direct all scheduling communications for such call to Megan Chu at Calderwood & Harkness LLP at the contact information set forth below.
Penterra's agreement to engage in discussions and its request for information shall not be construed as a waiver of any right or remedy, an extension of any deadline, or a commitment to refrain from exercising any right available under the SPA or applicable law during the pendency of such discussions.
VIII. Closing
We appreciate your prompt attention to this matter. Penterra remains committed to constructive engagement with Veridian and the Stockholder Representative, and we are available to discuss any of the matters raised herein at your convenience. However, as stated above, nothing in this letter or in any subsequent communication shall constitute a waiver of, or limitation on, any right or remedy of Penterra under the SPA, at law, or in equity.
Please do not hesitate to contact me or Megan Chu with any questions regarding this letter or to coordinate the scheduling of the conference call referenced above.
Very truly yours,
CALDERWOOD & HARKNESS LLP
By: ________
Oliver Mackenzie Partner
Telephone: (212) 558-4127
Email: omackenzie@calderwoodharkness.com
Contact Information for Scheduling:
Megan Chu, Associate Calderwood & Harkness LLP Telephone: (212) 558-4293
Email: mchu@calderwoodharkness.com
cc (via email):
Thomas F. Holbrook, Esq. General Counsel & Secretary Penterra Pharmaceuticals Corp. 1100 Meridian Boulevard, Suite 400 Princeton, New Jersey 08540
Natalie Reiner Senior Vice President, Corporate Development Penterra Pharmaceuticals Corp. 1100 Meridian Boulevard, Suite 400 Princeton, New Jersey 08540
Megan Chu, Esq. Associate Calderwood & Harkness LLP 200 Park Avenue, 42nd Floor New York, New York 10166
David Ng, Stockholder Representative c/o Crestline Ventures, LP (per notice provisions of the SPA, Section 10.2)

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