Contract analysis

I. PURPOSE AND SCOPE OF THIS PROTOCOL This memorandum establishes mandatory protocols for the preservation of attorney-client privilege and work-product protection throughout Calderwood & Harkness LLP's engagement by Penterra Pharmaceuticals Corp. ("Penterra" or the "Client") in connection with the inquiry initiated by the Food and Drug Administration's Office of Prescription Drug Promotion ("OPDP"), bearing FDA refe

1. Digital Banner Advertisement — Material ID: ZVR-2023-BNR-044

2. Physician Email Blast — Material ID: ZVR-2023-EML-019

3. Sales Representative Detail Aid — Material ID: ZVR-2023-DA-007 These materials are at the center of the OPDP's concerns and will be the primary focus of the internal investigation and the formal response to the agency. It must be emphasized that the OPDP Inquiry raises significant potential enforcement risk for Penterra. The issuance of an untitled letter or a Warning Letter by OPDP, while itself a regulatory acti

II. APPLICABLE LEGAL PRINCIPLES A. Attorney-Client Privilege The attorney-client privilege is the oldest recognized privilege for confidential communications in the common law. It protects from compelled disclosure confidential communications made between an attorney and a client for the purpose of obtaining or providing legal advice. Under federal common law, which will govern privilege questions in connection with

III. DESIGNATION OF AUTHORIZED PERSONS The preservation of privilege requires that confidential communications be limited to a defined group of authorized individuals. The inadvertent or careless disclosure of privileged materials to unauthorized persons — whether within or outside the organization — can result in waiver of the privilege. Accordingly, the following individuals are designated as "Authorized Persons" f

IV. DOCUMENT-HANDLING PROCEDURES Proper handling of documents is essential to the preservation of privilege and work-product protection. This section sets forth the mandatory procedures for marking, labeling, storing, and transmitting all documents generated or received in connection with this engagement. A. Privileged Document Marking and Labeling All memoranda, draft analyses, legal research memoranda, investigatio

V. COMMUNICATION GUIDELINES WITH PENTERRA PERSONNEL A. Interviews of Penterra Employees As part of the internal investigation of Zelvara® promotional practices, Calderwood & Harkness will conduct interviews of Penterra employees who have knowledge of the development, review, approval, and dissemination of the three promotional materials at issue in the OPDP Inquiry. These interviews are a critical component of the in

VI. PROTOCOLS FOR ENGAGEMENT OF TAVRENIS STERN CONSULTING GROUP LLC A. Engagement Structure — "At the Direction of Counsel" Calderwood & Harkness intends to engage Tavrenis Stern Consulting Group LLC ("Tavrenis Stern"), located at 311 South Wacker Drive, Suite 2400, Chicago, Illinois 60606, to perform e-discovery and forensic review services in connection with the internal investigation. Specifically, Tavrenis Stern

VII. PROTOCOLS FOR CO-COUNSEL ENGAGEMENT (WHITFIELD BAUER & ASSOCIATES LLP) A. Anticipated Engagement Calderwood & Harkness anticipates engaging Whitfield Bauer & Associates LLP ("Whitfield Bauer"), located at 1330 Connecticut Avenue NW, Suite 500, Washington, DC 20036, as FDA regulatory specialist co-counsel in this matter. Whitfield Bauer's engagement is anticipated to provide deep regulatory expertise in connectio

VIII. SEGREGATION OF PRIVILEGED MATERIALS FROM BUSINESS RECORDS A. General Principle Privileged communications and attorney work product must be maintained separately from Penterra's ordinary business records at all times. The commingling of privileged materials with non-privileged business records creates a significant risk that privileged materials will be inadvertently produced in response to discovery requests, g

IX. INADVERTENT DISCLOSURE PROCEDURES A. Clawback Protocol Despite the most diligent precautions, the possibility of inadvertent disclosure of privileged materials to a third party can never be entirely eliminated. In the event that privileged materials are inadvertently disclosed to any third party — including but not limited to the FDA, DOJ, OIG, any court, opposing counsel in any related proceeding, or any other p

1. Immediate Notification. The person who discovers or becomes aware of the inadvertent disclosure must immediately notify Leonard Cross (Responsible Partner) and Jeffrey Park (Lead Associate). Notification should be made by telephone if possible, followed by a confirming email marked as privileged.

2. Prompt Assertion of Privilege. Upon notification, Calderwood & Harkness will promptly assert the attorney-client privilege and/or work-product protection over the inadvertently disclosed materials and demand the return, sequestration, or destruction of the disclosed materials and all copies thereof. The assertion and demand will be made in writing to the recipient of the disclosed materials.

3. Reliance on Federal Rule of Evidence 502(b). Under Fed. R. Evid. 502(b), an inadvertent disclosure of privileged materials in a federal proceeding or to a federal office or agency does not constitute a waiver of the privilege if: (i) the disclosure was inadvertent; (ii) the holder of the privilege took reasonable steps to prevent disclosure; and (iii) the holder promptly took reasonable steps to rectify the error,

4. Protective Order or Clawback Agreement. If applicable proceedings involve a protective order or clawback agreement (such as an order under Fed. R. Evid. 502(d)), Calderwood & Harkness will invoke the provisions of such order or agreement to secure the return or sequestration of the disclosed materials.

5. Documentation. The inadvertent disclosure must be documented in a detailed memorandum to file, prepared by the attorney who manages the clawback response. The memorandum should describe: (a) the circumstances of the disclosure, including the date, the identity of the recipient, and the manner of disclosure; (b) a description of the materials disclosed (without reproducing the privileged content in unnecessary deta

X. COMMUNICATIONS WITH THIRD PARTIES AND REGULATORS A. FDA/OPDP Communications All formal communications with the Food and Drug Administration's Office of Prescription Drug Promotion in connection with OPDP-2023-1847 will be submitted on behalf of Penterra Pharmaceuticals Corp. It is important to recognize that regulatory submissions to the FDA are generally not protected by the attorney-client privilege or the work-