Contract analysis

I. PURPOSE This memorandum formally memorializes the closing of Matter No. 1018-00002 following the successful resolution of the inquiry initiated by 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"), into the promotional materials and sales-representative communications of Penterra Pharmaceuticals Corp. ("Penterr

II. MATTER SUMMARY A. Engagement Overview Calderwood & Harkness LLP ("the Firm") was engaged on October 30, 2023, by Penterra Pharmaceuticals Corp., a Delaware corporation with its principal executive offices located at 480 Overlook Drive, Suite 700, Summit, New Jersey 07901. Penterra's common stock is publicly traded on the New York Stock Exchange under the ticker symbol PTPH. The engagement was made through the Com

1. Digital Banner Ad (ZVR-2023-BNR-044). This digital display advertisement ran on the MedLinkPro physician education platform from April 15, 2023, through August 31, 2023. The OPDP's inquiry identified two principal deficiencies. First, the banner ad prominently featured the claim "Fastest Onset in Its Class," a comparative superiority claim that lacked adequate substantiation from head-to-head clinical trial data o

2. Physician Email Blast (ZVR-2023-EML-019). This electronic communication was sent on June 7, 2023, to approximately 42,000 neurologists and primary-care physicians. The email presented efficacy data from the Phase III SUMMIT-3 clinical trial using a bar chart with a truncated y-axis, which had the effect of visually exaggerating the efficacy differential between Zelvara® and placebo. The underlying data showed a 2-

3. Sales Representative Detail Aid (ZVR-2023-DA-007). This printed sales-aid document was approved by Penterra's internal Promotional Review Committee ("PRC") on March 22, 2023, and distributed to the Company's field sales force for use during in-person and virtual physician detailing visits. The detail aid cited the Harmon et al. poster presentation from the American Headache Society Annual Scientific Meeting 2022 a

III. KEY MILESTONES AND TIMELINE The following is a chronological summary of the key milestones and events relevant to this matter, from the underlying FDA approval of Zelvara® through the closing of the engagement: The timeline reflects that the engagement spanned approximately 116 days from opening (October 30, 2023) to closure (February 22, 2024). The Firm's work was substantially front-loaded during the November–

IV. FDA DISPOSITION On February 19, 2024, Penterra Pharmaceuticals Corp. received a close-out letter from the Office of Prescription Drug Promotion, signed by Dr. Carla M. Witherspoon, Pharm.D., Regulatory Review Officer, confirming that OPDP considers the matter designated as OPDP-2023-1847 to be resolved. The close-out letter specifically acknowledged Penterra's cooperation throughout the inquiry process and cited

V. SUMMARY OF CORRECTIVE ACTIONS IMPLEMENTED The following seven corrective actions were described in Penterra's formal response to the OPDP dated January 12, 2024, and were accepted by the FDA as the basis for closing the inquiry. Each action is summarized below with its implementation date and current status:

1. Immediate Withdrawal of Cited Materials. All three promotional materials identified in the OPDP inquiry — the digital banner ad (ZVR-2023-BNR-044), the physician email blast (ZVR-2023-EML-019), and the sales representative detail aid (ZVR-2023-DA-007) — were withdrawn from circulation and all distribution channels. Withdrawal was completed on November 3, 2023, eighteen days after receipt of the inquiry letter and

2. Corrective "Dear Healthcare Provider" Letter. A corrective communication was sent on December 11, 2023, to the approximately 42,000 neurologists and primary-care physicians who had received the physician email blast (ZVR-2023-EML-019). The letter was signed by Dr. Rajeev Anand, M.D., Ph.D., Penterra's Chief Medical Officer, and was reviewed and approved by Dr. Hannah Whitfield of Whitfield Bauer & Associates LLP p

3. Revised Promotional Review Committee Standard Operating Procedures. Penterra adopted and implemented revised PRC SOPs effective January 2, 2024. The revised SOPs incorporate several significant changes, including: (a) a requirement for unanimous Medical Affairs sign-off on all promotional materials containing efficacy claims or graphical presentations of clinical data, eliminating the prior majority-vote approval

4. Sales-Force Retraining. Penterra conducted mandatory promotional-compliance retraining for all 680 field sales representatives. The training program covered FDA promotional-compliance requirements, the Company's revised promotional policies and procedures, the prohibition on off-label promotion, and the specific lessons learned from the OPDP inquiry. Training was delivered through a combination of live virtual ses

5. Termination of Ridgeline Health Analytics LLC. Penterra issued a notice of termination to Ridgeline Health Analytics LLC on December 18, 2023. In accordance with the 90-day termination clause in the Master Services Agreement dated March 15, 2021, the termination becomes effective on March 15, 2024. The decision to terminate Ridgeline reflected the Firm's findings, discussed in the internal investigation summary be

6. Engagement of Successor Agency. Penterra has engaged Calloway & March Communications LLC ("Calloway & March") as its successor promotional-services agency, effective March 18, 2024. The Calloway & March engagement letter incorporates enhanced compliance requirements, including independent medical-legal review of all promotional claims and representations prior to submission to Penterra's PRC for approval.

7. Enhanced Monitoring Program. Penterra has implemented a quarterly audit program under which the Medical Affairs department will review a random sample of 10% of field sales-representative interactions (drawn from CRM call notes, recorded detailing sessions, and other available records) to monitor compliance with FDA promotional requirements and Penterra's internal policies. The program is designed to provide ongoi

VI. INTERNAL INVESTIGATION SUMMARY Calderwood & Harkness LLP conducted a comprehensive internal review of Penterra's Zelvara®-related promotional practices, the results of which are detailed in the privileged Internal Investigation Findings Memorandum dated December 20, 2023, delivered to Margaret Tan, EVP & General Counsel. The investigation was conducted under the direction of counsel and is protected by the attorn

VII. SECURITIES DISCLOSURE Given Penterra's status as a publicly traded company listed on the New York Stock Exchange, the Firm provided advice on the Company's securities-disclosure obligations in connection with the OPDP inquiry. The following is a summary of the securities-related actions taken during the engagement. Calderwood & Harkness delivered a securities-disclosure advice memorandum to Margaret Tan on Novem

VIII. FINAL BILLING SUMMARY A. Calderwood & Harkness LLP The billing arrangement for this engagement was on an hourly basis, with a blended rate of approximately $785 per hour across the engagement team. The engagement letter included a fee cap of $450,000 for the Firm's fees and expenses. Final billed fees: $387,240 Fee cap: $450,000 Amount under fee cap: $62,760 The final billed amount reflects the efficient execut

IX. DOCUMENT RETENTION AND PRIVILEGE-LOG MAINTENANCE A. Document-Retention Obligations All matter files associated with Matter No. 1018-00002, including work product, correspondence, memoranda, research materials, notes, and all other documents generated or received in connection with this engagement, shall be retained in accordance with Calderwood & Harkness's standard document-retention policy. The Firm's policy re

1. Engagement Letter between Calderwood & Harkness LLP and Penterra Pharmaceuticals Corp. (October 30, 2023)

2. Privilege and Work-Product Protection Protocol Memorandum (October 31, 2023)

3. Securities-Disclosure Advice Memorandum (November 3, 2023)

4. Preliminary Assessment Memorandum (November 6, 2023)

5. Internal Investigation Plan Memorandum (November 8, 2023)

6. Co-Counsel Engagement Letter — Whitfield Bauer & Associates LLP (November 10, 2023)

7. Promotional-Labeling Compliance Analysis Memorandum (December 4, 2023)

8. Corrective "Dear Healthcare Provider" Letter (December 11, 2023)

9. Internal Investigation Findings Memorandum (December 20, 2023)

10. Draft FDA Response Letter (January 5, 2024)

11. Final FDA Response Letter as submitted (January 12, 2024)

12. All attorney-client communications with Penterra personnel, including but not limited to Margaret Tan (EVP & General Counsel), Dr. Rajeev Anand (Chief Medical Officer), Christine Holloway, Derek Foss (VP, Commercial Operations & Marketing), Dr. Lina Gerhardt (Senior Director, Medical Affairs), and Alan Renwick (Director, PRC)

13. All communications with co-counsel Whitfield Bauer & Associates LLP made in connection with the provision of legal advice to the client

14. All communications with Tavrenis Stern Consulting Group LLC made at the direction of counsel in connection with the internal investigation The complete privilege log, which contains a detailed entry for each privileged document and communication, is maintained as a separate appendix to the matter file.

X. RESIDUAL CONSIDERATIONS AND OPEN ITEMS A. Ongoing Penterra Obligations Although the OPDP inquiry has been formally resolved and this matter is being closed, certain corrective-action commitments made by Penterra in its formal response to the FDA will continue beyond the matter closure date. These ongoing obligations are the responsibility of Penterra's in-house legal, compliance, and medical affairs teams and do n

XI. RECOMMENDATION Based on the foregoing, Matter No. 1018-00002 (Penterra Pharmaceuticals Corp. / FDA OPDP Inquiry OPDP-2023-1847) is hereby recommended for closure effective February 22, 2024, with a matter-status designation of closed_completed. The OPDP inquiry has been resolved favorably, with no Warning Letter issued and no referral to the Department of Justice or the Office of Inspector General. All engagement

XII. SIGNATURE BLOCK PREPARED BY: ________________________________________ Jeffrey Park Lead Associate, Litigation (General) Calderwood & Harkness LLP Date: February 22, 2024 APPROVED BY: ________________________________________ Leonard Cross Responsible Partner Calderwood & Harkness LLP Date: ________ ________________________________________ Nathaniel Bower Billing Partner Calderwood & Harkness LLP Date: ________ PR