1018-00002 · Penterra Pharmaceuticals Corp · Engagement

engagement-letter-penterra.docx DOCUMENT M&A / Corporate

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CALDERWOOD & HARKNESS LLP Counsellors at Law

600 Lexington Avenue New York, New York 10022

Telephone: (212) 554-7000 Facsimile: (212) 554-7001 www.calderwoodharkness.com

October 30, 2023

VIA HAND DELIVERY AND EMAIL (m.tan@penterrapharma.com)

Margaret Tan, Esq. Executive Vice President & General Counsel Penterra Pharmaceuticals Corp. 480 Overlook Drive, Suite 700 Summit, New Jersey 07901

Re: Engagement of Calderwood & Harkness LLP — FDA Office of Prescription Drug Promotion Inquiry (OPDP-2023-1847) Regarding Zelvara® (trepivant sodium) Promotional Materials

Matter Number: 1018-00002

Dear Ms. Tan:

We are pleased to confirm the engagement of Calderwood & Harkness LLP as outside counsel to Penterra Pharmaceuticals Corp. in connection with the matter described below. This engagement letter (together with the enclosed Calderwood & Harkness LLP Standard Terms of Engagement, which are incorporated herein by reference, collectively, this "Agreement") sets forth the terms and conditions governing our representation of the Company. We ask that you review this letter carefully and countersign the acknowledgment and acceptance set forth below to confirm your agreement with these terms.

1. Purpose and Engagement Overview

This letter confirms that Penterra Pharmaceuticals Corp. ("Penterra" or the "Company"), a corporation organized and existing under the laws of the State of Delaware and publicly traded on the New York Stock Exchange under the ticker symbol PTPH, has retained Calderwood & Harkness LLP ("the Firm" or "C&H") to serve as its outside counsel in connection with the matter described herein.

On or about October 12, 2023, the U.S. Food and Drug Administration's Office of Prescription Drug Promotion ("OPDP"), a division of the Center for Drug Evaluation and Research ("CDER"), issued a formal inquiry letter bearing reference number OPDP-2023-1847 (the "OPDP Inquiry" or the "Inquiry") directed to Penterra. The Company received the OPDP Inquiry on October 16, 2023.

The OPDP Inquiry concerns allegedly misleading promotional materials and sales representative communications disseminated by or on behalf of Penterra in connection with the Company's marketed product Zelvara® (trepivant sodium), NDA #214-837. Zelvara® was approved by the FDA on October 11, 2019, for the acute treatment of migraine with or without aura in adults and is commercially available in 75 mg and 150 mg oral tablet dosage forms. The OPDP Inquiry identifies specific promotional materials and communications that, in the Agency's preliminary assessment, may contain claims or presentations that are inconsistent with the approved labeling for Zelvara® or that otherwise fail to meet the requirements of the Federal Food, Drug, and Cosmetic Act ("FD&C Act") and applicable FDA regulations governing prescription drug advertising and promotion.

As stated in the OPDP Inquiry, the Company's original response deadline is November 15, 2023, which is thirty (30) calendar days from the date of the Company's receipt of the Inquiry. The Firm understands that the Company may wish to seek an extension of this deadline, and we are prepared to assist with such a request, as described further in Section 2 below.

The Firm's engagement in this matter is effective as of the date of the Company's countersignature of this letter.

2. Scope of Representation

The scope of the Firm's representation of the Company in this matter shall encompass the services described in the following sub-sections. Any services beyond those described below will be undertaken only upon the mutual written agreement of the parties.

2.1 FDA Response

The Firm will advise and assist Penterra in preparing and submitting a comprehensive response to the OPDP Inquiry. The OPDP Inquiry identifies three specific promotional materials as the subject of the Agency's concerns:

(a) A digital banner advertisement (Material ID: ZVR-2023-BNR-044);

(b) A physician-targeted email blast (Material ID: ZVR-2023-EML-019); and

The Firm's services in connection with the FDA response will include, but are not limited to, the following:

(i) Reviewing and analyzing the OPDP Inquiry letter, the three cited promotional materials, the approved prescribing information (labeling) for Zelvara®, and all relevant clinical data and literature referenced in or supporting the cited materials;

(ii) Preparing a comprehensive written response to the FDA on behalf of the Company, addressing the specific allegations and concerns raised by OPDP with respect to each of the three cited materials, including substantive defenses, if available, and any proposed corrective action plan as may be appropriate or advisable under the circumstances;

(iii) Assisting the Company in requesting an extension of the November 15, 2023 response deadline, if warranted, including preparation of the extension request letter and coordination with OPDP regarding an acceptable revised deadline;

(iv) Advising the Company on potential regulatory outcomes following the submission of the response, including but not limited to the distinction between Warning Letters, Untitled Letters, close-out letters, and the possibility of referrals to other FDA offices, the Federal Trade Commission, or other regulatory or enforcement agencies; and

(v) Advising the Company on any follow-up communications or supplemental submissions to the FDA that may be required or advisable following the initial response.

2.2 Internal Review of Promotional Practices

In connection with the OPDP Inquiry and in order to enable the Firm to render informed legal advice to the Company, the Firm will conduct an internal review and investigation of Penterra's promotional practices related to Zelvara® during the relevant time period. This internal review will be conducted at the direction of counsel and for the purpose of rendering legal advice to the Company. The Firm's services in this regard will include:

(a) Reviewing all promotional materials related to Zelvara® that were reviewed and/or approved by the Company's Promotional Review Committee ("PRC") during the period from January 1, 2023 through the date of the OPDP Inquiry, with particular focus on the three cited materials and any related versions, drafts, or adaptations thereof;

(b) Reviewing PRC meeting minutes, voting records, internal review comments, and approval documentation for the relevant period, in order to assess the adequacy and functioning of the Company's promotional review and approval processes;

(c) Reviewing sales representative communications, customer relationship management ("CRM") system records, call notes, speaker program materials, and related documents and electronically stored information, to the extent relevant to the claims and presentations identified in the OPDP Inquiry;

(d) Conducting witness interviews of relevant Penterra personnel, including but not limited to members of the PRC, medical affairs staff, regulatory affairs staff, marketing and commercial operations personnel, and field sales representatives, as identified in consultation with the Company's General Counsel; and

(e) Preparing a privileged memorandum summarizing the findings of the internal review for use in connection with the Company's response to the OPDP Inquiry and for the Company's legal and compliance planning purposes.

2.3 Related Advisory Services

In addition to the services described above, the Firm will provide the following related advisory services as part of this engagement:

(a) Advising the Company on its securities-disclosure obligations arising from or related to the OPDP Inquiry, including an assessment of whether the Inquiry constitutes a material event requiring disclosure on Form 8-K under Item 8.01 or otherwise, and advising on appropriate risk-factor disclosures in the Company's periodic reports on Form 10-K and Form 10-Q, as applicable;

(b) Advising the Company on the establishment and maintenance of attorney-client privilege and attorney work-product protection protocols for the internal investigation described in Section 2.2 above, including the preparation and distribution of a written privilege protocol to guide communications among the Firm, the Company, and any co-counsel or third-party consultants engaged in connection with this matter; and

(c) Providing a general regulatory and litigation-risk assessment related to the OPDP Inquiry, including an evaluation of the potential for follow-on governmental investigations, qui tam or whistleblower litigation, private securities class action litigation, or other legal proceedings that may arise from or relate to the subject matter of the Inquiry.

2.4 Limitations on Scope

The Company understands and agrees that the scope of this engagement is limited to the matters described in Sections 2.1 through 2.3 above, and is further subject to the following express limitations:

(a) This engagement does not include the representation of any individual officer, director, employee, or agent of Penterra in his or her personal capacity. The Firm represents the Company as an entity, and not any individual. If the interests of any individual diverge from or become adverse to the interests of the Company, the Firm will advise such individual to seek separate legal counsel at his or her own expense.

(b) This engagement does not encompass representation of the Company in any separate enforcement action, civil or criminal investigation, or proceeding commenced by the U.S. Department of Justice ("DOJ"), the Office of Inspector General of the U.S. Department of Health and Human Services ("OIG-HHS"), or any other federal or state enforcement agency, unless such representation is separately agreed upon in writing by the parties. In the event that any such enforcement action or investigation arises in connection with the subject matter of the OPDP Inquiry, the Firm will promptly notify the Company and the parties will discuss whether the scope of this engagement should be expanded or whether separate engagement terms are appropriate.

(c) This engagement does not include any patent, trademark, trade dress, copyright, or other intellectual property matters related to Zelvara® or any other Penterra product, even if such matters are tangentially related to the promotional materials at issue in the OPDP Inquiry.

3. Engagement Team

The following attorneys have been assigned to this matter and will comprise the core engagement team:

Responsible Partner — Leonard Cross Mr. Cross is a partner in the Firm's Tax practice group. He will serve as the Responsible Partner for this engagement, providing overall partner-level oversight and supervision of the engagement, strategic direction, and final signatory authority on all major submissions to the FDA and other regulatory authorities in connection with this matter. Mr. Cross will review and approve all significant work product before it is delivered to the Company or filed with the Agency.

Billing Partner — Nathaniel Bower Mr. Bower is a partner in the Firm's Bankruptcy & Restructuring practice group. He will serve as the Billing Partner for this engagement and will be responsible for billing, client-relationship management, engagement economics, and ensuring compliance with the billing and fee arrangements set forth in Section 4 of this letter. All billing inquiries and questions regarding invoices or fee arrangements should be directed to Mr. Bower.

Lead Associate — Jeffrey Park Mr. Park is an associate in the Firm's Litigation (General) practice group. He will serve as the Lead Associate for this engagement and will be responsible for day-to-day matter management, drafting of the response to the OPDP Inquiry and related correspondence, coordination of the internal investigation described in Section 2.2, and serving as the primary point of contact for routine communications between the Firm and the Company. Unless otherwise directed by the Company, day-to-day communications regarding the progress and status of the engagement should be directed to Mr. Park.

Working Associate — Audrey Zhou Ms. Zhou is an associate in the Firm's Capital Markets practice group. She will support the engagement team with regulatory research, document review, drafting support, and analysis of securities-disclosure considerations in connection with this matter.

The Firm may assign additional attorneys, paralegals, or other professional staff to this engagement as reasonably necessary to ensure the timely and effective provision of legal services. The Firm will notify the Company of any material changes to the composition of the engagement team, including the departure of any member of the core team described above or the addition of any attorney who is expected to bill a significant number of hours to the matter.

4. Billing Arrangements and Fee Cap

4.1 Hourly Billing

The Firm shall bill for professional services rendered in connection with this engagement on an hourly basis. The blended rate for the engagement team described in Section 3 above is approximately $785 per hour. Individual attorney billing rates are available upon request and may vary depending on the seniority and experience of the attorney performing the work. The Firm's standard billing rates are subject to annual adjustment, typically effective January 1 of each calendar year, and the Company will be notified in advance of any rate changes applicable to this engagement.

All professional time will be recorded and billed in increments of one-tenth (0.1) of an hour (i.e., six-minute increments). Each time entry will identify the attorney or professional performing the work, the date on which the work was performed, and a description of the services rendered.

4.2 Fee Cap

The parties have agreed to a fee cap of $450,000 (four hundred fifty thousand dollars) for all Calderwood & Harkness LLP professional fees incurred in connection with this matter (the "Fee Cap"). The Fee Cap represents the maximum amount of C&H professional fees that may be charged to the Company in connection with this engagement, absent a written modification of this Agreement.

The following terms apply to the Fee Cap:

(a) The Fee Cap applies exclusively to professional fees charged by Calderwood & Harkness LLP attorneys and professional staff for services rendered in connection with this engagement. The Fee Cap does not include disbursements, out-of-pocket expenses, or costs incurred by the Firm and reimbursable under Section 4.3 below.

(b) The Fee Cap does not include the fees and expenses of any co-counsel or third-party consultants engaged with the Company's consent in accordance with Section 6 below. Such fees and expenses are the separate responsibility of the Company.

(c) In the event that the scope of the matter expands materially beyond the scope described in Section 2 above — including, by way of example and not limitation, the commencement of a formal enforcement action, the issuance of a Warning Letter requiring a comprehensive response and corrective action plan, or the expansion of the internal investigation to cover additional products, therapeutic areas, or promotional campaigns — the parties will discuss in good faith an appropriate adjustment to the Fee Cap. Any adjustment to the Fee Cap must be agreed upon in writing by both parties before additional fees in excess of the original Fee Cap are incurred.

4.3 Expenses and Disbursements

The Company shall reimburse the Firm for reasonable out-of-pocket expenses and disbursements incurred in connection with this engagement. Reimbursable expenses include, but are not limited to, the following: travel costs (including airfare, ground transportation, lodging, and meals), document reproduction and printing charges, overnight courier and express delivery charges, long-distance telephone charges, court reporting and transcript fees, database and electronic research charges (including Westmark Data Systems, Sundial Solutions, and similar services), and filing fees.

Any single expense item exceeding $5,000 will require the prior written approval of the Company's General Counsel (or her designee) before such expense is incurred. For purposes of this provision, written approval may be given by email.

4.4 Billing Frequency and Payment Terms

The Firm will render monthly invoices to the Company for professional fees and expenses incurred during the preceding calendar month. Invoices will be transmitted electronically to the attention of Margaret Tan, Executive Vice President & General Counsel, unless the Company designates a different billing contact in writing.

Payment of each invoice is due within thirty (30) calendar days of the date of the invoice. All payments shall be made in United States dollars by wire transfer or check, as directed by the Firm. Invoices remaining unpaid beyond the thirty-day period may accrue interest at the rate of 1.0% per month (12% per annum), or the maximum rate permitted by applicable law, whichever is less.

Each invoice will contain sufficient detail to identify the nature of the services rendered, the name and billing rate of the attorney or professional performing the work, the number of hours expended, and the applicable charges for each entry. Expense reimbursements will be itemized separately.

Any billing inquiries or disputes should be directed to Nathaniel Bower, who will work with the Company to resolve any questions in a prompt and collegial manner. The Company agrees to raise any billing disputes within sixty (60) days of the invoice date; failure to raise a dispute within this period shall constitute acceptance of the invoice.

5. Conflict Check

In accordance with the New York Rules of Professional Conduct and the Firm's internal conflict-checking procedures, the Firm has conducted a comprehensive conflicts check based on the information provided by the Company. As of the date of this letter, no conflicts of interest have been identified that would preclude the Firm from undertaking this representation.

The Company acknowledges and understands that Calderwood & Harkness LLP is a large, full-service law firm that currently represents, and may in the future represent, other clients in matters unrelated to this engagement, including entities and individuals in the pharmaceutical, biotechnology, healthcare, and life sciences industries. The Company consents to such representations, provided that they are not directly adverse to Penterra in this specific matter. This consent is limited to unrelated matters and does not constitute a blanket waiver of the Company's right to object to any representation that is directly adverse to Penterra's interests in the subject matter of this engagement.

In the event that a conflict of interest arises during the course of this engagement — whether arising from the Firm's representation of another client, the emergence of new facts, or any other circumstance — the Firm will promptly notify the Company and take all appropriate steps in accordance with the New York Rules of Professional Conduct, which may include seeking a waiver from the affected parties or, if a waiver cannot be obtained or is not appropriate, withdrawing from this engagement.

6. Authority to Engage Co-Counsel and Third-Party Consultants

From time to time during this engagement, it may be necessary or advisable to engage co-counsel with specialized expertise or third-party consultants to assist in the effective representation of the Company. The Firm may, with the prior written consent of the Company, engage such co-counsel or consultants on the following terms:

Co-Counsel. The Firm may, with the prior written consent of Margaret Tan (or her designee), which consent may be provided by email, engage co-counsel with specialized expertise relevant to the subject matter of this engagement. At this time, the Firm contemplates engaging the following co-counsel:

Whitfield Bauer & Associates LLP, a Washington, DC-based law firm with recognized expertise in FDA regulatory matters, including OPDP enforcement actions, prescription drug advertising and promotion compliance, and promotional-labeling compliance analysis. Whitfield Bauer would be engaged to assist with OPDP response strategy, analysis of the cited promotional materials in light of current OPDP enforcement trends, and guidance on corrective action plan development. The Firm will provide the Company with Whitfield Bauer's proposed engagement terms, including applicable billing rates, for the Company's approval before the engagement commences.

Whitfield Bauer's professional fees and expenses will be billed directly to Penterra or through Calderwood & Harkness LLP, as agreed upon by the parties. Such fees and expenses are separate from, and not included within, the C&H Fee Cap described in Section 4.2 above.

Third-Party Consultants. The Firm may also, with the Company's prior written consent (which may be provided by email from Margaret Tan or her designee), engage third-party consultants as necessary for the internal investigation described in Section 2.2 above or for other purposes related to this engagement. At this time, the Firm contemplates engaging the following consultant:

Tavrenis Stern Consulting Group LLC, a Chicago-based e-discovery, forensic data collection, and consulting firm. Tavrenis Stern would be engaged to assist with the collection, processing, and review of electronically stored information, including sales representative CRM data, email communications, and other digital records relevant to the internal investigation. Tavrenis Stern's proposed scope of work and fee estimate will be provided to the Company for approval before the engagement commences.

Tavrenis Stern's fees and expenses are separate from, and not included within, the C&H Fee Cap described in Section 4.2 above.

All co-counsel and third-party consultants engaged in connection with this matter will be engaged under the direction and supervision of Calderwood & Harkness LLP for the purpose of rendering legal advice to the Company and, to the fullest extent permitted by applicable law, for the purpose of preserving and maintaining the protections of the attorney-client privilege and the attorney work-product doctrine over communications, analyses, and work product generated in connection with this engagement.

7. Attorney-Client Privilege and Confidentiality

All communications between the Firm and the Company in connection with this engagement are intended to be protected by the attorney-client privilege and, where applicable, the attorney work-product doctrine. The Company and the Firm recognize the importance of maintaining these protections, particularly in light of the regulatory nature of this matter and the potential for related governmental investigations or private litigation.

The Company agrees that it will not voluntarily disclose privileged communications, attorney work product, or the substance of legal advice rendered by the Firm to any third party without first consulting with the Firm regarding the potential impact of such disclosure on the applicable privilege protections. This obligation shall not prevent the Company from making disclosures required by law or regulation, including disclosures required by the securities laws and regulations administered by the U.S. Securities and Exchange Commission, provided that the Company will use reasonable efforts to notify the Firm in advance of any such compelled disclosure and to limit the scope of any such disclosure to the extent permitted by law.

The Firm will prepare and distribute to the Company a written privilege and work-product protection protocol (the "Privilege Protocol") to guide communications among the Firm, the Company, co-counsel, and third-party consultants during the internal investigation described in Section 2.2 above. The Privilege Protocol will address, among other things, guidelines for marking and handling privileged documents, protocols for conducting and documenting witness interviews, limitations on the dissemination of investigation findings, and best practices for maintaining the confidentiality of privileged communications in the ordinary course of business operations.

All documents, memoranda, reports, analyses, and other materials generated or reviewed by the Firm as part of the internal investigation will be clearly labeled as "PRIVILEGED AND CONFIDENTIAL — ATTORNEY-CLIENT COMMUNICATION / ATTORNEY WORK PRODUCT" where appropriate, and will be maintained in a manner consistent with the preservation of applicable privilege protections.

8. Communications and Client Contacts

For purposes of this engagement, the Firm's primary point of contact at the Company will be Margaret Tan, Executive Vice President & General Counsel. All significant communications regarding the strategy, direction, and status of the engagement will be directed to Ms. Tan. The Firm's day-to-day point of contact for routine communications, scheduling, document requests, and matter-management logistics will be Jeffrey Park, Lead Associate.

In the course of this engagement, the Firm will need to communicate with various Company personnel for purposes of gathering factual information, conducting witness interviews, and coordinating the internal investigation. The Firm anticipates that it will need to communicate with the following individuals, among others:

• Dr. Rajeev Anand, M.D., Ph.D., Chief Medical Officer

• Christine Holloway, Vice President, Regulatory Affairs

• Derek Foss, Vice President, Commercial Operations & Marketing

• Dr. Lina Gerhardt, Pharm.D., Senior Director, Medical Affairs

• Alan Renwick, Director, Promotional Review Committee

All communications between the Firm and Company personnel will be coordinated through, or conducted with the knowledge and consent of, Margaret Tan or her designee. The Firm will not contact Company personnel regarding substantive matters related to this engagement without first informing Ms. Tan, except in circumstances where prior notification is impracticable, in which case the Firm will notify Ms. Tan promptly thereafter.

The Company agrees to make its personnel reasonably available for interviews, meetings, and other communications as may be necessary for the Firm to provide effective legal representation in this matter.

9. Document Preservation and Litigation Hold

The Firm has advised the Company of its obligation to preserve all documents and electronically stored information ("ESI") that may be relevant to the OPDP Inquiry, the internal investigation, and any related governmental investigations or legal proceedings that may arise. The Company has been advised to implement and maintain a comprehensive litigation hold and document-preservation directive (a "Preservation Notice") covering, at a minimum, the following categories of documents and ESI:

(a) All documents and ESI related to the Zelvara® promotional campaign known internally as the "Clarity Campaign," including strategy documents, creative briefs, copy platform documents, and campaign performance metrics;

(b) All documents and ESI related to the three promotional materials cited in the OPDP Inquiry (Material IDs: ZVR-2023-BNR-044, ZVR-2023-EML-019, and ZVR-2023-DA-007), including all drafts, versions, annotations, review comments, and approval records;

(c) All Promotional Review Committee meeting minutes, agendas, voting records, review forms, and related documentation for the period from January 1, 2022 through the present;

(d) All sales representative CRM records, call notes, detail records, and communications — including emails, text messages, and instant messages — related to the promotion of Zelvara® during the relevant period;

(e) All correspondence, submissions, and communications between Penterra and the FDA regarding OPDP-2023-1847 or any related regulatory matter; and

(f) All internal communications (including emails, memoranda, presentations, and reports) related to any of the foregoing categories.

The Firm will assist the Company in preparing and distributing an appropriate Preservation Notice to all relevant custodians and will advise the Company on the implementation and ongoing monitoring of the litigation hold. The Company understands that the failure to preserve relevant documents and ESI may result in adverse consequences, including sanctions or adverse inferences in any related legal proceeding.

10. Termination of Engagement

Either party may terminate this engagement at any time upon written notice to the other party. Such notice may be delivered by email, overnight courier, or hand delivery.

In the event that the Company terminates this engagement, the Company shall remain responsible for the payment of all professional fees and reimbursable expenses incurred by the Firm through the date of termination, subject to the Fee Cap set forth in Section 4.2 above. The Firm will cooperate in the orderly transition of the matter to successor counsel designated by the Company, including the transfer of the Company's files and work product in the Firm's possession.

In the event that the Firm terminates this engagement — which the Firm will do only for good cause, such as the Company's failure to pay invoices when due, the Company's failure to cooperate in the representation, or the emergence of an irremediable conflict of interest — the Firm will take all reasonable steps to protect the Company's interests during the transition period and will facilitate the prompt transfer of the matter to successor counsel. The Firm will comply with all applicable ethical rules and, where required, will seek leave of any tribunal before which the Firm is appearing on behalf of the Company before withdrawing from the representation.

Upon the conclusion or termination of this engagement, the Firm's representation of the Company in this matter will cease. The Firm will have no continuing obligation to advise the Company on developments in law, regulation, enforcement policy, or other matters that may affect the subject matter of this engagement, unless the parties enter into a new engagement agreement covering such services. The conclusion of this engagement will not affect the Firm's ongoing obligations with respect to the confidentiality of the Company's information, which will survive the termination of the engagement.

11. No Guarantee of Outcome

The Company acknowledges and understands that the Firm has made no promises, representations, or guarantees regarding the outcome of the OPDP Inquiry, the internal investigation, or any related governmental investigation, enforcement action, or legal proceeding. The practice of law involves inherent uncertainty, and the outcome of any regulatory or legal matter depends on many factors beyond the control of the Firm, including the actions and decisions of governmental agencies, opposing parties, and other third parties.

Any expressions of professional opinion regarding the likelihood of particular outcomes, the potential range of regulatory consequences, or the strengths and weaknesses of the Company's position are based on the Firm's professional judgment, informed by the facts and circumstances known to the Firm at the time such opinions are expressed. Such opinions do not constitute warranties, guarantees, or promises of any kind, and the Company acknowledges that it is not relying on any such opinion as a guarantee of results.

12. Governing Law

This engagement letter and the rights and obligations of the parties hereunder shall be governed by and construed in accordance with the laws of the State of New York, without giving effect to any choice-of-law or conflict-of-laws rules or provisions that would cause the application of the laws of any other jurisdiction.

13. Entire Agreement and Amendments

This letter, together with the enclosed Calderwood & Harkness LLP Standard Terms of Engagement (which are incorporated herein by reference), constitutes the entire agreement between the parties with respect to the Firm's engagement in connection with the matter described herein. This Agreement supersedes all prior and contemporaneous discussions, negotiations, understandings, and agreements, whether oral or written, between the parties with respect to the subject matter hereof.

No amendment, modification, or waiver of any provision of this Agreement shall be effective unless made in writing and signed by an authorized representative of each party. No failure or delay by either party in exercising any right or remedy under this Agreement shall operate as a waiver thereof.

We appreciate the confidence that Penterra Pharmaceuticals Corp. has placed in Calderwood & Harkness LLP, and we look forward to working with you and your team on this important matter. Please do not hesitate to contact Leonard Cross or me if you have any questions regarding the terms of this engagement or any other aspect of our representation.

If the foregoing terms are acceptable, please countersign this letter in the space provided below and return a fully executed copy to the Firm for our records.

Very truly yours,

CALDERWOOD & HARKNESS LLP

By: ________

Leonard Cross Partner

By: ________

Nathaniel Bower Partner

ACKNOWLEDGMENT AND ACCEPTANCE

Agreed and Accepted on behalf of Penterra Pharmaceuticals Corp.:

The undersigned, being duly authorized to act on behalf of Penterra Pharmaceuticals Corp., hereby acknowledges receipt of this engagement letter, confirms that she has read and understands the terms and conditions set forth herein, and agrees to such terms and conditions on behalf of the Company.

PENTERRA PHARMACEUTICALS CORP.

By: ________

Name: Margaret Tan

Title: Executive Vice President & General Counsel

Date: ________

Enclosure: Calderwood & Harkness LLP Standard Terms of Engagement (incorporated by reference)

cc: Leonard Cross, Partner, Calderwood & Harkness LLP (via email) Nathaniel Bower, Partner, Calderwood & Harkness LLP (via email) Jeffrey Park, Associate, Calderwood & Harkness LLP (via email) Audrey Zhou, Associate, Calderwood & Harkness LLP (via email) Calderwood & Harkness LLP file (Matter No. 1018-00002)

CALDERWOOD & HARKNESS LLP Counsellors at Law
600 Lexington Avenue New York, New York 10022
Telephone: (212) 554-7000 Facsimile: (212) 554-7001 www.calderwoodharkness.com
October 30, 2023
VIA HAND DELIVERY AND EMAIL (m.tan@penterrapharma.com)
Margaret Tan, Esq. Executive Vice President & General Counsel Penterra Pharmaceuticals Corp. 480 Overlook Drive, Suite 700 Summit, New Jersey 07901
Re: Engagement of Calderwood & Harkness LLP — FDA Office of Prescription Drug Promotion Inquiry (OPDP-2023-1847) Regarding Zelvara® (trepivant sodium) Promotional Materials
Matter Number: 1018-00002
Dear Ms. Tan:
We are pleased to confirm the engagement of Calderwood & Harkness LLP as outside counsel to Penterra Pharmaceuticals Corp. in connection with the matter described below. This engagement letter (together with the enclosed Calderwood & Harkness LLP Standard Terms of Engagement, which are incorporated herein by reference, collectively, this "Agreement") sets forth the terms and conditions governing our representation of the Company. We ask that you review this letter carefully and countersign the acknowledgment and acceptance set forth below to confirm your agreement with these terms.
1. Purpose and Engagement Overview
This letter confirms that Penterra Pharmaceuticals Corp. ("Penterra" or the "Company"), a corporation organized and existing under the laws of the State of Delaware and publicly traded on the New York Stock Exchange under the ticker symbol PTPH, has retained Calderwood & Harkness LLP ("the Firm" or "C&H") to serve as its outside counsel in connection with the matter described herein.
On or about October 12, 2023, the U.S. Food and Drug Administration's Office of Prescription Drug Promotion ("OPDP"), a division of the Center for Drug Evaluation and Research ("CDER"), issued a formal inquiry letter bearing reference number OPDP-2023-1847 (the "OPDP Inquiry" or the "Inquiry") directed to Penterra. The Company received the OPDP Inquiry on October 16, 2023.
The OPDP Inquiry concerns allegedly misleading promotional materials and sales representative communications disseminated by or on behalf of Penterra in connection with the Company's marketed product Zelvara® (trepivant sodium), NDA #214-837. Zelvara® was approved by the FDA on October 11, 2019, for the acute treatment of migraine with or without aura in adults and is commercially available in 75 mg and 150 mg oral tablet dosage forms. The OPDP Inquiry identifies specific promotional materials and communications that, in the Agency's preliminary assessment, may contain claims or presentations that are inconsistent with the approved labeling for Zelvara® or that otherwise fail to meet the requirements of the Federal Food, Drug, and Cosmetic Act ("FD&C Act") and applicable FDA regulations governing prescription drug advertising and promotion.
As stated in the OPDP Inquiry, the Company's original response deadline is November 15, 2023, which is thirty (30) calendar days from the date of the Company's receipt of the Inquiry. The Firm understands that the Company may wish to seek an extension of this deadline, and we are prepared to assist with such a request, as described further in Section 2 below.
The Firm's engagement in this matter is effective as of the date of the Company's countersignature of this letter.
2. Scope of Representation
The scope of the Firm's representation of the Company in this matter shall encompass the services described in the following sub-sections. Any services beyond those described below will be undertaken only upon the mutual written agreement of the parties.
2.1 FDA Response
The Firm will advise and assist Penterra in preparing and submitting a comprehensive response to the OPDP Inquiry. The OPDP Inquiry identifies three specific promotional materials as the subject of the Agency's concerns:
(a) A digital banner advertisement (Material ID: ZVR-2023-BNR-044);
(b) A physician-targeted email blast (Material ID: ZVR-2023-EML-019); and
(c) A sales representative detail aid (Material ID: ZVR-2023-DA-007).
The Firm's services in connection with the FDA response will include, but are not limited to, the following:
(i) Reviewing and analyzing the OPDP Inquiry letter, the three cited promotional materials, the approved prescribing information (labeling) for Zelvara®, and all relevant clinical data and literature referenced in or supporting the cited materials;
(ii) Preparing a comprehensive written response to the FDA on behalf of the Company, addressing the specific allegations and concerns raised by OPDP with respect to each of the three cited materials, including substantive defenses, if available, and any proposed corrective action plan as may be appropriate or advisable under the circumstances;
(iii) Assisting the Company in requesting an extension of the November 15, 2023 response deadline, if warranted, including preparation of the extension request letter and coordination with OPDP regarding an acceptable revised deadline;
(iv) Advising the Company on potential regulatory outcomes following the submission of the response, including but not limited to the distinction between Warning Letters, Untitled Letters, close-out letters, and the possibility of referrals to other FDA offices, the Federal Trade Commission, or other regulatory or enforcement agencies; and
(v) Advising the Company on any follow-up communications or supplemental submissions to the FDA that may be required or advisable following the initial response.
2.2 Internal Review of Promotional Practices
In connection with the OPDP Inquiry and in order to enable the Firm to render informed legal advice to the Company, the Firm will conduct an internal review and investigation of Penterra's promotional practices related to Zelvara® during the relevant time period. This internal review will be conducted at the direction of counsel and for the purpose of rendering legal advice to the Company. The Firm's services in this regard will include:
(a) Reviewing all promotional materials related to Zelvara® that were reviewed and/or approved by the Company's Promotional Review Committee ("PRC") during the period from January 1, 2023 through the date of the OPDP Inquiry, with particular focus on the three cited materials and any related versions, drafts, or adaptations thereof;
(b) Reviewing PRC meeting minutes, voting records, internal review comments, and approval documentation for the relevant period, in order to assess the adequacy and functioning of the Company's promotional review and approval processes;
(c) Reviewing sales representative communications, customer relationship management ("CRM") system records, call notes, speaker program materials, and related documents and electronically stored information, to the extent relevant to the claims and presentations identified in the OPDP Inquiry;
(d) Conducting witness interviews of relevant Penterra personnel, including but not limited to members of the PRC, medical affairs staff, regulatory affairs staff, marketing and commercial operations personnel, and field sales representatives, as identified in consultation with the Company's General Counsel; and
(e) Preparing a privileged memorandum summarizing the findings of the internal review for use in connection with the Company's response to the OPDP Inquiry and for the Company's legal and compliance planning purposes.
2.3 Related Advisory Services
In addition to the services described above, the Firm will provide the following related advisory services as part of this engagement:
(a) Advising the Company on its securities-disclosure obligations arising from or related to the OPDP Inquiry, including an assessment of whether the Inquiry constitutes a material event requiring disclosure on Form 8-K under Item 8.01 or otherwise, and advising on appropriate risk-factor disclosures in the Company's periodic reports on Form 10-K and Form 10-Q, as applicable;
(b) Advising the Company on the establishment and maintenance of attorney-client privilege and attorney work-product protection protocols for the internal investigation described in Section 2.2 above, including the preparation and distribution of a written privilege protocol to guide communications among the Firm, the Company, and any co-counsel or third-party consultants engaged in connection with this matter; and
(c) Providing a general regulatory and litigation-risk assessment related to the OPDP Inquiry, including an evaluation of the potential for follow-on governmental investigations, qui tam or whistleblower litigation, private securities class action litigation, or other legal proceedings that may arise from or relate to the subject matter of the Inquiry.
2.4 Limitations on Scope
The Company understands and agrees that the scope of this engagement is limited to the matters described in Sections 2.1 through 2.3 above, and is further subject to the following express limitations:
(a) This engagement does not include the representation of any individual officer, director, employee, or agent of Penterra in his or her personal capacity. The Firm represents the Company as an entity, and not any individual. If the interests of any individual diverge from or become adverse to the interests of the Company, the Firm will advise such individual to seek separate legal counsel at his or her own expense.
(b) This engagement does not encompass representation of the Company in any separate enforcement action, civil or criminal investigation, or proceeding commenced by the U.S. Department of Justice ("DOJ"), the Office of Inspector General of the U.S. Department of Health and Human Services ("OIG-HHS"), or any other federal or state enforcement agency, unless such representation is separately agreed upon in writing by the parties. In the event that any such enforcement action or investigation arises in connection with the subject matter of the OPDP Inquiry, the Firm will promptly notify the Company and the parties will discuss whether the scope of this engagement should be expanded or whether separate engagement terms are appropriate.
(c) This engagement does not include any patent, trademark, trade dress, copyright, or other intellectual property matters related to Zelvara® or any other Penterra product, even if such matters are tangentially related to the promotional materials at issue in the OPDP Inquiry.
3. Engagement Team
The following attorneys have been assigned to this matter and will comprise the core engagement team:
Responsible Partner — Leonard Cross Mr. Cross is a partner in the Firm's Tax practice group. He will serve as the Responsible Partner for this engagement, providing overall partner-level oversight and supervision of the engagement, strategic direction, and final signatory authority on all major submissions to the FDA and other regulatory authorities in connection with this matter. Mr. Cross will review and approve all significant work product before it is delivered to the Company or filed with the Agency.
Billing Partner — Nathaniel Bower Mr. Bower is a partner in the Firm's Bankruptcy & Restructuring practice group. He will serve as the Billing Partner for this engagement and will be responsible for billing, client-relationship management, engagement economics, and ensuring compliance with the billing and fee arrangements set forth in Section 4 of this letter. All billing inquiries and questions regarding invoices or fee arrangements should be directed to Mr. Bower.
Lead Associate — Jeffrey Park Mr. Park is an associate in the Firm's Litigation (General) practice group. He will serve as the Lead Associate for this engagement and will be responsible for day-to-day matter management, drafting of the response to the OPDP Inquiry and related correspondence, coordination of the internal investigation described in Section 2.2, and serving as the primary point of contact for routine communications between the Firm and the Company. Unless otherwise directed by the Company, day-to-day communications regarding the progress and status of the engagement should be directed to Mr. Park.
Working Associate — Audrey Zhou Ms. Zhou is an associate in the Firm's Capital Markets practice group. She will support the engagement team with regulatory research, document review, drafting support, and analysis of securities-disclosure considerations in connection with this matter.
The Firm may assign additional attorneys, paralegals, or other professional staff to this engagement as reasonably necessary to ensure the timely and effective provision of legal services. The Firm will notify the Company of any material changes to the composition of the engagement team, including the departure of any member of the core team described above or the addition of any attorney who is expected to bill a significant number of hours to the matter.
4. Billing Arrangements and Fee Cap
4.1 Hourly Billing
The Firm shall bill for professional services rendered in connection with this engagement on an hourly basis. The blended rate for the engagement team described in Section 3 above is approximately $785 per hour. Individual attorney billing rates are available upon request and may vary depending on the seniority and experience of the attorney performing the work. The Firm's standard billing rates are subject to annual adjustment, typically effective January 1 of each calendar year, and the Company will be notified in advance of any rate changes applicable to this engagement.
All professional time will be recorded and billed in increments of one-tenth (0.1) of an hour (i.e., six-minute increments). Each time entry will identify the attorney or professional performing the work, the date on which the work was performed, and a description of the services rendered.
4.2 Fee Cap
The parties have agreed to a fee cap of $450,000 (four hundred fifty thousand dollars) for all Calderwood & Harkness LLP professional fees incurred in connection with this matter (the "Fee Cap"). The Fee Cap represents the maximum amount of C&H professional fees that may be charged to the Company in connection with this engagement, absent a written modification of this Agreement.
The following terms apply to the Fee Cap:
(a) The Fee Cap applies exclusively to professional fees charged by Calderwood & Harkness LLP attorneys and professional staff for services rendered in connection with this engagement. The Fee Cap does not include disbursements, out-of-pocket expenses, or costs incurred by the Firm and reimbursable under Section 4.3 below.
(b) The Fee Cap does not include the fees and expenses of any co-counsel or third-party consultants engaged with the Company's consent in accordance with Section 6 below. Such fees and expenses are the separate responsibility of the Company.
(c) In the event that the scope of the matter expands materially beyond the scope described in Section 2 above — including, by way of example and not limitation, the commencement of a formal enforcement action, the issuance of a Warning Letter requiring a comprehensive response and corrective action plan, or the expansion of the internal investigation to cover additional products, therapeutic areas, or promotional campaigns — the parties will discuss in good faith an appropriate adjustment to the Fee Cap. Any adjustment to the Fee Cap must be agreed upon in writing by both parties before additional fees in excess of the original Fee Cap are incurred.
4.3 Expenses and Disbursements
The Company shall reimburse the Firm for reasonable out-of-pocket expenses and disbursements incurred in connection with this engagement. Reimbursable expenses include, but are not limited to, the following: travel costs (including airfare, ground transportation, lodging, and meals), document reproduction and printing charges, overnight courier and express delivery charges, long-distance telephone charges, court reporting and transcript fees, database and electronic research charges (including Westmark Data Systems, Sundial Solutions, and similar services), and filing fees.
Any single expense item exceeding $5,000 will require the prior written approval of the Company's General Counsel (or her designee) before such expense is incurred. For purposes of this provision, written approval may be given by email.
4.4 Billing Frequency and Payment Terms
The Firm will render monthly invoices to the Company for professional fees and expenses incurred during the preceding calendar month. Invoices will be transmitted electronically to the attention of Margaret Tan, Executive Vice President & General Counsel, unless the Company designates a different billing contact in writing.
Payment of each invoice is due within thirty (30) calendar days of the date of the invoice. All payments shall be made in United States dollars by wire transfer or check, as directed by the Firm. Invoices remaining unpaid beyond the thirty-day period may accrue interest at the rate of 1.0% per month (12% per annum), or the maximum rate permitted by applicable law, whichever is less.
Each invoice will contain sufficient detail to identify the nature of the services rendered, the name and billing rate of the attorney or professional performing the work, the number of hours expended, and the applicable charges for each entry. Expense reimbursements will be itemized separately.
Any billing inquiries or disputes should be directed to Nathaniel Bower, who will work with the Company to resolve any questions in a prompt and collegial manner. The Company agrees to raise any billing disputes within sixty (60) days of the invoice date; failure to raise a dispute within this period shall constitute acceptance of the invoice.
5. Conflict Check
In accordance with the New York Rules of Professional Conduct and the Firm's internal conflict-checking procedures, the Firm has conducted a comprehensive conflicts check based on the information provided by the Company. As of the date of this letter, no conflicts of interest have been identified that would preclude the Firm from undertaking this representation.
The Company acknowledges and understands that Calderwood & Harkness LLP is a large, full-service law firm that currently represents, and may in the future represent, other clients in matters unrelated to this engagement, including entities and individuals in the pharmaceutical, biotechnology, healthcare, and life sciences industries. The Company consents to such representations, provided that they are not directly adverse to Penterra in this specific matter. This consent is limited to unrelated matters and does not constitute a blanket waiver of the Company's right to object to any representation that is directly adverse to Penterra's interests in the subject matter of this engagement.
In the event that a conflict of interest arises during the course of this engagement — whether arising from the Firm's representation of another client, the emergence of new facts, or any other circumstance — the Firm will promptly notify the Company and take all appropriate steps in accordance with the New York Rules of Professional Conduct, which may include seeking a waiver from the affected parties or, if a waiver cannot be obtained or is not appropriate, withdrawing from this engagement.
6. Authority to Engage Co-Counsel and Third-Party Consultants
From time to time during this engagement, it may be necessary or advisable to engage co-counsel with specialized expertise or third-party consultants to assist in the effective representation of the Company. The Firm may, with the prior written consent of the Company, engage such co-counsel or consultants on the following terms:
Co-Counsel. The Firm may, with the prior written consent of Margaret Tan (or her designee), which consent may be provided by email, engage co-counsel with specialized expertise relevant to the subject matter of this engagement. At this time, the Firm contemplates engaging the following co-counsel:
Whitfield Bauer & Associates LLP, a Washington, DC-based law firm with recognized expertise in FDA regulatory matters, including OPDP enforcement actions, prescription drug advertising and promotion compliance, and promotional-labeling compliance analysis. Whitfield Bauer would be engaged to assist with OPDP response strategy, analysis of the cited promotional materials in light of current OPDP enforcement trends, and guidance on corrective action plan development. The Firm will provide the Company with Whitfield Bauer's proposed engagement terms, including applicable billing rates, for the Company's approval before the engagement commences.
Whitfield Bauer's professional fees and expenses will be billed directly to Penterra or through Calderwood & Harkness LLP, as agreed upon by the parties. Such fees and expenses are separate from, and not included within, the C&H Fee Cap described in Section 4.2 above.
Third-Party Consultants. The Firm may also, with the Company's prior written consent (which may be provided by email from Margaret Tan or her designee), engage third-party consultants as necessary for the internal investigation described in Section 2.2 above or for other purposes related to this engagement. At this time, the Firm contemplates engaging the following consultant:
Tavrenis Stern Consulting Group LLC, a Chicago-based e-discovery, forensic data collection, and consulting firm. Tavrenis Stern would be engaged to assist with the collection, processing, and review of electronically stored information, including sales representative CRM data, email communications, and other digital records relevant to the internal investigation. Tavrenis Stern's proposed scope of work and fee estimate will be provided to the Company for approval before the engagement commences.
Tavrenis Stern's fees and expenses are separate from, and not included within, the C&H Fee Cap described in Section 4.2 above.
All co-counsel and third-party consultants engaged in connection with this matter will be engaged under the direction and supervision of Calderwood & Harkness LLP for the purpose of rendering legal advice to the Company and, to the fullest extent permitted by applicable law, for the purpose of preserving and maintaining the protections of the attorney-client privilege and the attorney work-product doctrine over communications, analyses, and work product generated in connection with this engagement.
7. Attorney-Client Privilege and Confidentiality
All communications between the Firm and the Company in connection with this engagement are intended to be protected by the attorney-client privilege and, where applicable, the attorney work-product doctrine. The Company and the Firm recognize the importance of maintaining these protections, particularly in light of the regulatory nature of this matter and the potential for related governmental investigations or private litigation.
The Company agrees that it will not voluntarily disclose privileged communications, attorney work product, or the substance of legal advice rendered by the Firm to any third party without first consulting with the Firm regarding the potential impact of such disclosure on the applicable privilege protections. This obligation shall not prevent the Company from making disclosures required by law or regulation, including disclosures required by the securities laws and regulations administered by the U.S. Securities and Exchange Commission, provided that the Company will use reasonable efforts to notify the Firm in advance of any such compelled disclosure and to limit the scope of any such disclosure to the extent permitted by law.
The Firm will prepare and distribute to the Company a written privilege and work-product protection protocol (the "Privilege Protocol") to guide communications among the Firm, the Company, co-counsel, and third-party consultants during the internal investigation described in Section 2.2 above. The Privilege Protocol will address, among other things, guidelines for marking and handling privileged documents, protocols for conducting and documenting witness interviews, limitations on the dissemination of investigation findings, and best practices for maintaining the confidentiality of privileged communications in the ordinary course of business operations.
All documents, memoranda, reports, analyses, and other materials generated or reviewed by the Firm as part of the internal investigation will be clearly labeled as "PRIVILEGED AND CONFIDENTIAL — ATTORNEY-CLIENT COMMUNICATION / ATTORNEY WORK PRODUCT" where appropriate, and will be maintained in a manner consistent with the preservation of applicable privilege protections.
8. Communications and Client Contacts
For purposes of this engagement, the Firm's primary point of contact at the Company will be Margaret Tan, Executive Vice President & General Counsel. All significant communications regarding the strategy, direction, and status of the engagement will be directed to Ms. Tan. The Firm's day-to-day point of contact for routine communications, scheduling, document requests, and matter-management logistics will be Jeffrey Park, Lead Associate.
In the course of this engagement, the Firm will need to communicate with various Company personnel for purposes of gathering factual information, conducting witness interviews, and coordinating the internal investigation. The Firm anticipates that it will need to communicate with the following individuals, among others:
•  Dr. Rajeev Anand, M.D., Ph.D., Chief Medical Officer
•  Christine Holloway, Vice President, Regulatory Affairs
•  Derek Foss, Vice President, Commercial Operations & Marketing
•  Dr. Lina Gerhardt, Pharm.D., Senior Director, Medical Affairs
•  Alan Renwick, Director, Promotional Review Committee
All communications between the Firm and Company personnel will be coordinated through, or conducted with the knowledge and consent of, Margaret Tan or her designee. The Firm will not contact Company personnel regarding substantive matters related to this engagement without first informing Ms. Tan, except in circumstances where prior notification is impracticable, in which case the Firm will notify Ms. Tan promptly thereafter.
The Company agrees to make its personnel reasonably available for interviews, meetings, and other communications as may be necessary for the Firm to provide effective legal representation in this matter.
9. Document Preservation and Litigation Hold
The Firm has advised the Company of its obligation to preserve all documents and electronically stored information ("ESI") that may be relevant to the OPDP Inquiry, the internal investigation, and any related governmental investigations or legal proceedings that may arise. The Company has been advised to implement and maintain a comprehensive litigation hold and document-preservation directive (a "Preservation Notice") covering, at a minimum, the following categories of documents and ESI:
(a) All documents and ESI related to the Zelvara® promotional campaign known internally as the "Clarity Campaign," including strategy documents, creative briefs, copy platform documents, and campaign performance metrics;
(b) All documents and ESI related to the three promotional materials cited in the OPDP Inquiry (Material IDs: ZVR-2023-BNR-044, ZVR-2023-EML-019, and ZVR-2023-DA-007), including all drafts, versions, annotations, review comments, and approval records;
(c) All Promotional Review Committee meeting minutes, agendas, voting records, review forms, and related documentation for the period from January 1, 2022 through the present;
(d) All sales representative CRM records, call notes, detail records, and communications — including emails, text messages, and instant messages — related to the promotion of Zelvara® during the relevant period;
(e) All correspondence, submissions, and communications between Penterra and the FDA regarding OPDP-2023-1847 or any related regulatory matter; and
(f) All internal communications (including emails, memoranda, presentations, and reports) related to any of the foregoing categories.
The Firm will assist the Company in preparing and distributing an appropriate Preservation Notice to all relevant custodians and will advise the Company on the implementation and ongoing monitoring of the litigation hold. The Company understands that the failure to preserve relevant documents and ESI may result in adverse consequences, including sanctions or adverse inferences in any related legal proceeding.
10. Termination of Engagement
Either party may terminate this engagement at any time upon written notice to the other party. Such notice may be delivered by email, overnight courier, or hand delivery.
In the event that the Company terminates this engagement, the Company shall remain responsible for the payment of all professional fees and reimbursable expenses incurred by the Firm through the date of termination, subject to the Fee Cap set forth in Section 4.2 above. The Firm will cooperate in the orderly transition of the matter to successor counsel designated by the Company, including the transfer of the Company's files and work product in the Firm's possession.
In the event that the Firm terminates this engagement — which the Firm will do only for good cause, such as the Company's failure to pay invoices when due, the Company's failure to cooperate in the representation, or the emergence of an irremediable conflict of interest — the Firm will take all reasonable steps to protect the Company's interests during the transition period and will facilitate the prompt transfer of the matter to successor counsel. The Firm will comply with all applicable ethical rules and, where required, will seek leave of any tribunal before which the Firm is appearing on behalf of the Company before withdrawing from the representation.
Upon the conclusion or termination of this engagement, the Firm's representation of the Company in this matter will cease. The Firm will have no continuing obligation to advise the Company on developments in law, regulation, enforcement policy, or other matters that may affect the subject matter of this engagement, unless the parties enter into a new engagement agreement covering such services. The conclusion of this engagement will not affect the Firm's ongoing obligations with respect to the confidentiality of the Company's information, which will survive the termination of the engagement.
11. No Guarantee of Outcome
The Company acknowledges and understands that the Firm has made no promises, representations, or guarantees regarding the outcome of the OPDP Inquiry, the internal investigation, or any related governmental investigation, enforcement action, or legal proceeding. The practice of law involves inherent uncertainty, and the outcome of any regulatory or legal matter depends on many factors beyond the control of the Firm, including the actions and decisions of governmental agencies, opposing parties, and other third parties.
Any expressions of professional opinion regarding the likelihood of particular outcomes, the potential range of regulatory consequences, or the strengths and weaknesses of the Company's position are based on the Firm's professional judgment, informed by the facts and circumstances known to the Firm at the time such opinions are expressed. Such opinions do not constitute warranties, guarantees, or promises of any kind, and the Company acknowledges that it is not relying on any such opinion as a guarantee of results.
12. Governing Law
This engagement letter and the rights and obligations of the parties hereunder shall be governed by and construed in accordance with the laws of the State of New York, without giving effect to any choice-of-law or conflict-of-laws rules or provisions that would cause the application of the laws of any other jurisdiction.
13. Entire Agreement and Amendments
This letter, together with the enclosed Calderwood & Harkness LLP Standard Terms of Engagement (which are incorporated herein by reference), constitutes the entire agreement between the parties with respect to the Firm's engagement in connection with the matter described herein. This Agreement supersedes all prior and contemporaneous discussions, negotiations, understandings, and agreements, whether oral or written, between the parties with respect to the subject matter hereof.
No amendment, modification, or waiver of any provision of this Agreement shall be effective unless made in writing and signed by an authorized representative of each party. No failure or delay by either party in exercising any right or remedy under this Agreement shall operate as a waiver thereof.
We appreciate the confidence that Penterra Pharmaceuticals Corp. has placed in Calderwood & Harkness LLP, and we look forward to working with you and your team on this important matter. Please do not hesitate to contact Leonard Cross or me if you have any questions regarding the terms of this engagement or any other aspect of our representation.
If the foregoing terms are acceptable, please countersign this letter in the space provided below and return a fully executed copy to the Firm for our records.
Very truly yours,
CALDERWOOD & HARKNESS LLP
By: ________
Leonard Cross Partner
By: ________
Nathaniel Bower Partner
ACKNOWLEDGMENT AND ACCEPTANCE
Agreed and Accepted on behalf of Penterra Pharmaceuticals Corp.:
The undersigned, being duly authorized to act on behalf of Penterra Pharmaceuticals Corp., hereby acknowledges receipt of this engagement letter, confirms that she has read and understands the terms and conditions set forth herein, and agrees to such terms and conditions on behalf of the Company.
PENTERRA PHARMACEUTICALS CORP.
By: ________
Name: Margaret Tan
Title: Executive Vice President & General Counsel
Date: ________
Enclosure: Calderwood & Harkness LLP Standard Terms of Engagement (incorporated by reference)
cc: Leonard Cross, Partner, Calderwood & Harkness LLP (via email) Nathaniel Bower, Partner, Calderwood & Harkness LLP (via email) Jeffrey Park, Associate, Calderwood & Harkness LLP (via email) Audrey Zhou, Associate, Calderwood & Harkness LLP (via email) Calderwood & Harkness LLP file (Matter No. 1018-00002)

CALDERWOOD & HARKNESS LLP Counsellors at Law

CALDERWOOD & HARKNESS LLP

ACKNOWLEDGMENT AND ACCEPTANCE

PENTERRA PHARMACEUTICALS CORP.

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