1018-00004 · Penterra Pharmaceuticals Corp · Engagement

engagement-letter-penterra.docx DOCUMENT Finance & Banking

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PRIVILEGED AND CONFIDENTIAL

CALDERWOOD & HARKNESS LLP 280 Park Avenue, 34th Floor New York, NY 10017

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

Additional Office: 101 Carnegie Center, Suite 500 Princeton, NJ 08540 Telephone: (609) 228-3400

March 20, 2023

Nathaniel Briggs, Esq. Vice President & General Counsel Penterra Pharmaceuticals Corp. 200 Biopharma Boulevard, Suite 1400 Princeton, NJ 08540

Dear Mr. Briggs:

1. Introduction and Purpose

Calderwood & Harkness LLP ("C&H" or the "Firm") is pleased to confirm its engagement by Penterra Pharmaceuticals Corp. ("Penterra" or the "Company") for legal representation in connection with the matter described herein. We greatly value our relationship with Penterra and appreciate the confidence the Company has placed in the Firm in selecting us for this significant engagement.

This letter sets forth the terms and conditions under which the Firm will provide legal services to the Company. The purpose of this engagement letter is to define the scope of our representation, the responsibilities of both the Firm and the Company, and the financial and administrative arrangements governing our professional relationship. We ask that you review this letter carefully and, if its terms are acceptable, execute and return the enclosed counterpart copy as described in Section 13 below.

This engagement follows prior discussions between Miriam Calloway, Partner in the Firm's Healthcare & Life Sciences Practice Group, and Rebecca Liang, Esq., Associate General Counsel, Clinical Affairs, of Penterra, as well as subsequent conversations with you regarding the nature and scope of the representation. Based on those discussions and the materials provided by the Company to date, we have developed a thorough understanding of the Company's objectives and the key legal issues involved in the contemplated transactions.

For the Firm's internal records and billing purposes, this engagement has been assigned Firm Matter Number: 1018-00004. We ask that the Company reference this matter number on all correspondence, communications, and payment remittances directed to the Firm in connection with this engagement.

2. Scope of Engagement

The Firm has been retained to represent Penterra in the negotiation, drafting, and finalization of the following agreements and related matters, each as more particularly described below:

(a) Master Clinical Trial Agreement ("MCTA"). The Firm will negotiate and draft a Master Clinical Trial Agreement between Penterra Pharmaceuticals Corp., as sponsor, and Veridian Health Research Network, Inc. ("Veridian"), a Delaware 501(c)(3) corporation headquartered at 750 Research Parkway, 8th Floor, Philadelphia, PA 19104, as site network operator. The MCTA will govern the terms and conditions under which Veridian and its affiliated clinical trial sites will participate in Penterra's Phase III clinical trial conducted under Protocol PPC-4871-III (short title: CLARION — Clinical Assessment of Response with Longitudinal Investigation in ONcology) for the investigational compound penterafenib (PPC-4871), an oral multi-kinase inhibitor targeting advanced hepatocellular carcinoma ("HCC"). The MCTA is expected to address, among other things, the obligations of the sponsor and the site network operator, study conduct requirements, financial terms, data rights, publication rights, indemnification, insurance, regulatory compliance, termination, and dispute resolution.

(b) Site-Network Agreements. The Firm will draft and negotiate individual site joinder agreements (each, a "Site Joinder Agreement") for up to thirty-eight (38) Veridian Network academic medical centers and affiliated research institutions across fourteen (14) states. The Site Joinder Agreements will incorporate by reference the terms of the MCTA and will contain site-specific provisions, including site-level budgets, investigator identification, regulatory and institutional review board ("IRB") approval requirements, and local compliance obligations. The lead sites for the CLARION trial are anticipated to be Graystone University Medical Center, located in Philadelphia, Pennsylvania, and Lakemont Medical Center, located in Chicago, Illinois. The Firm will prioritize the negotiation and finalization of the Site Joinder Agreements for these two lead sites, with remaining site agreements to follow on a rolling basis as Veridian provides site-specific information and regulatory approvals.

(c) Ancillary Agreements. The Firm will draft and/or review ancillary documents relating to the MCTA and the Site Joinder Agreements, including but not limited to: (i) principal investigator agreements; (ii) co-principal investigator agreements; (iii) an intellectual property side letter addressing inventions, discoveries, and data generated during the course of the CLARION trial; (iv) investigator undertaking forms; (v) insurance-related correspondence, including certificates of insurance and evidence of coverage; and (vi) exhibits and schedules to the MCTA, including the study budget, study protocol summary, sample informed consent form annotations, and any other ancillary instruments required to effectuate the MCTA.

(d) Indemnification and Insurance Provisions. The Firm will negotiate the subject-injury indemnification provisions applicable to study subjects participating in the CLARION trial, sponsor and site reciprocal indemnification structures covering third-party claims, and insurance requirements for both sponsor and site-level coverage. This work will include analysis of applicable state law governing clinical trial liability and subject-injury compensation, coordination with the Company's risk management and insurance teams, and preparation of insurance-related exhibits to the MCTA.

(e) Regulatory Compliance Analysis. The Firm will provide legal advice and analysis regarding the regulatory compliance aspects of the MCTA and related agreements, including compliance with the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)) and applicable safe harbors, the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h) and related Open Payments reporting obligations, the Health Insurance Portability and Accountability Act of 1996 ("HIPAA") and its implementing regulations governing the use and disclosure of protected health information in the research context, and the financial disclosure requirements set forth in 21 C.F.R. Part 54 applicable to clinical investigators. For the avoidance of doubt, FDA regulatory strategy, IND maintenance, and related submissions to the U.S. Food and Drug Administration in connection with IND No. 132,847 are being handled separately by Castleton & Hargrove LLP, located at 1100 Connecticut Avenue NW, Suite 900, Washington, DC 20036, and are expressly outside the scope of this engagement.

(f) Closing and Post-Closing. The Firm will prepare closing deliverables, including a closing checklist, closing certificates, secretary's certificates, officer's certificates, signature pages, and any other documents reasonably required to effectuate the execution and delivery of the MCTA and the Site Joinder Agreements. Following closing, the Firm will compile and deliver to the Company a closing binder (in both physical and electronic format) containing fully executed copies of all transaction documents.

Estimated Deal Value. Based on information provided by the Company, the total value of the MCTA and the Site Joinder Agreements is approximately Eighty Million Dollars ($80,000,000), covering site fees, per-patient payments, investigator grants, and operational costs over the CLARION trial's projected forty-two (42) month enrollment period. The Firm understands that the final aggregate value of the agreements may be adjusted based on the number of sites activated, enrollment rates, and protocol amendments during the course of the trial.

Counterparty Counsel. The Firm has been advised that Veridian Health Research Network, Inc. is represented in this matter by Whitmore, Jansen & Callahan LLP, 1500 Market Street, Suite 3200, Philadelphia, PA 19102. The lead partner for Veridian at Whitmore, Jansen & Callahan is Allison Whitmore. The Firm will coordinate all legal communications with Veridian's counsel as appropriate and in accordance with the applicable rules of professional conduct.

Scope Limitations. This engagement is limited to the matters described in subsections (a) through (f) above. Without limiting the generality of the foregoing, this engagement does not include:

(i) FDA regulatory matters, including IND maintenance, regulatory strategy, pre-approval inspection preparation, or communications with the FDA, all of which are being handled by Castleton & Hargrove LLP;

(ii) the separate Master Services Agreement between Penterra and Meridian Contract Research Organization, Inc., which was executed on January 15, 2023, and is outside the scope of this engagement;

(iii) securities law, capital markets advice, or other transactional corporate matters, which are being handled by Ridgeline Capital Markets LLC and such other advisors as the Company may engage from time to time; or

(iv) tax advice, audit matters, or accounting-related services, which are being handled by Townsend Independent Auditors LLP or such other advisors as the Company may engage.

Any expansion of the scope of this engagement will be mutually agreed upon in writing between the Firm and the Company prior to the commencement of any additional work.

3. Engagement Team

The Firm will assign the following attorneys to lead the engagement on behalf of Penterra:

Responsible Partner. Miriam Calloway, Partner, Healthcare & Life Sciences Practice Group. Ms. Calloway will serve as the responsible partner overseeing all aspects of the engagement and will be the primary point of contact for the Company on matters of legal strategy, negotiation, and senior-level client communications. Ms. Calloway has extensive experience in negotiating complex clinical trial agreements and research collaborations on behalf of pharmaceutical sponsors, academic medical centers, and contract research organizations. She can be reached directly at (212) 554-7112 or miriam.calloway@calderwoodharkness.com.

Billing Partner. Joel Strauss, Partner, Healthcare & Life Sciences Practice Group. Mr. Strauss will serve as the billing partner and will be responsible for fee arrangements, invoicing, budget management, and overall matter financial administration. Mr. Strauss has served as billing partner on numerous life sciences transactions and will ensure that the Firm's billing practices comply with the terms set forth in this engagement letter. He can be reached directly at (212) 554-7218 or joel.strauss@calderwoodharkness.com.

Lead Associate. Sean Morrissey, Associate, Healthcare & Life Sciences Practice Group. Mr. Morrissey will serve as the lead associate responsible for day-to-day drafting, negotiation support, redline management, and project management. Mr. Morrissey will coordinate directly with the Company's internal legal team and with counterparty counsel. He can be reached directly at (212) 554-7341 or sean.morrissey@calderwoodharkness.com.

Working Associate. Christopher Aiken, Associate, Healthcare & Life Sciences Practice Group. Mr. Aiken will provide additional support on research memoranda, regulatory compliance analysis (including Anti-Kickback Statute and Sunshine Act analysis), due diligence, and preparation of closing deliverables. He can be reached directly at (212) 554-7429 or christopher.aiken@calderwoodharkness.com.

The Firm may, from time to time, assign additional attorneys, paralegals, or other professional staff to the matter as appropriate to ensure the efficient and timely delivery of legal services. Before assigning any additional attorney to substantive work on this matter, the Firm will consult with the Company's primary legal contact, Rebecca Liang, Esq., Associate General Counsel, Clinical Affairs, to ensure alignment with the Company's expectations regarding staffing and cost management.

4. Client Contact Information

For purposes of this engagement, the Company has designated the following individuals as authorized contacts:

Primary Legal Contact. Rebecca Liang, Esq., Associate General Counsel, Clinical Affairs, Penterra Pharmaceuticals Corp., 200 Biopharma Boulevard, Suite 1400, Princeton, NJ 08540. Telephone: (609) 441-2200 ext. 3147. Email: rliang@penterapharma.com. All substantive legal communications, including draft agreements, redlines, legal memoranda, and negotiation strategy discussions, will be directed to Ms. Liang unless otherwise instructed by the Company. Ms. Liang will serve as the day-to-day legal contact and will be authorized to provide instructions to the Firm on all matters within the scope of this engagement.

Additional Contacts. The following individuals are also authorized contacts for the purposes indicated:

• Nathaniel Briggs, Esq., Vice President & General Counsel, Penterra Pharmaceuticals Corp. Mr. Briggs will be consulted for approval of strategic legal positions, material concessions in negotiation, and matters requiring authorized signatory approval. Telephone: (609) 441-2200 ext. 3001. Email: nbriggs@penterapharma.com.

• Samantha Novak, Director, Clinical Contracts, Penterra Pharmaceuticals Corp. Ms. Novak will serve as the Company's point of contact for contracts administration, document logistics, version control, and coordination of site-level information. Telephone: (609) 441-2200 ext. 3289. Email: snovak@penterapharma.com.

The Firm will rely on the instructions and authorizations of the individuals identified above. The Company agrees to notify the Firm promptly in writing if any of the designated contacts change or if additional individuals are authorized to provide instructions on behalf of the Company.

5. Fee Structure and Billing Arrangements

Basis of Fees. The Firm will bill for legal services rendered in connection with this engagement on an hourly basis at the Firm's standard hourly rates then in effect for the attorneys and professional staff assigned to the matter. The Firm's hourly rates reflect the experience, skill, and seniority of the professionals performing the work, as well as the complexity and demands of the matter.

Current Hourly Rates (2023). The Firm's current standard hourly rates for the professionals most likely to be assigned to this matter are as follows:

The specific rate applicable to each professional assigned to the matter will be reflected on the Firm's monthly invoices. The Firm's hourly rates are subject to annual adjustment, typically effective January 1 of each calendar year. The Firm will provide the Company with advance notice of any rate adjustments, which will be communicated in writing no later than thirty (30) days prior to the effective date of the adjustment. The adjusted rates will apply to all services rendered on or after the effective date of the adjustment.

Disbursements and Expenses. In addition to professional fees for attorney and staff time, the Firm will bill the Company for disbursements and out-of-pocket expenses reasonably incurred in connection with the engagement. Such disbursements and expenses may include, but are not limited to:

• Travel expenses, including airfare, ground transportation, lodging, and meals, incurred in connection with in-person negotiation sessions, site visits, or meetings at the Company's offices, Veridian's offices, or counterparty counsel's offices;

• Document production and reproduction costs, including photocopying, scanning, and printing charges;

• Overnight delivery and courier charges;

• Filing fees and recording charges, if applicable;

• Outside vendor charges, including but not limited to charges for process servers, legal research databases (to the extent not included in the Firm's overhead), court reporting services, and translation services, if applicable;

• Long-distance telephone charges and videoconference platform fees, to the extent not included in the Firm's standard overhead; and

• Such other reasonable and customary disbursements as may be incurred in the ordinary course of the engagement.

The Firm will endeavor to manage disbursements prudently and will obtain the Company's prior approval before incurring any single disbursement or expense item in excess of Five Thousand Dollars ($5,000.00).

Billing Cycle. Invoices will be issued on a monthly basis, typically within fifteen (15) business days following the close of each calendar month. Each invoice will include a detailed description of the services rendered during the billing period, the name and billing rate of the attorney(s) or professional staff performing each task, the time expended on each task (in increments of one-tenth of an hour), and an itemized listing of disbursements and expenses incurred.

Payment Terms. Payment of the Firm's invoices is due within thirty (30) days of the date of the Firm's invoice. The Company agrees to pay interest on past-due amounts at a rate of one percent (1.0%) per month (twelve percent (12%) per annum), or the maximum rate permitted by applicable law, whichever is lower. The Firm reserves the right, upon reasonable notice to the Company, to suspend work on the matter if any invoice remains unpaid for more than sixty (60) days past its due date, subject to the Firm's obligations under applicable rules of professional conduct.

6. Retainer

No retainer or advance deposit is required at the outset of this engagement. The Firm reserves the right to request a retainer or advance deposit against fees and disbursements if circumstances warrant, including but not limited to a material change in the scope or complexity of the engagement, or a pattern of late payment by the Company. Any such request will be made upon reasonable written notice to the Company. Any retainer received will be deposited in the Firm's client trust account and applied against fees and disbursements as invoiced. Any unused portion of the retainer will be returned to the Company upon the conclusion or termination of the engagement.

7. Conflicts of Interest

The Firm has conducted a conflicts check in accordance with its standard internal procedures and the applicable Rules of Professional Conduct, including the New York Rules of Professional Conduct (22 NYCRR Part 1200). Based on the information provided by the Company to date, including the identities of the parties, affiliated entities, and key individuals involved in the CLARION trial and the transactions contemplated by this engagement, no conflicts of interest have been identified that would preclude the Firm from undertaking this representation.

The conflicts check included searches against the following entities and individuals, among others: Veridian Health Research Network, Inc.; Graystone University Medical Center; Lakemont Medical Center; Whitmore, Jansen & Callahan LLP; Allison Whitmore; and such other relevant parties, counterparties, and affiliated persons as were identified by the Company or otherwise known to the Firm.

The Company acknowledges that the Firm is a large, multi-practice law firm that represents numerous clients across a wide range of industries and matters. The Firm represents, and will continue to represent, other clients in the pharmaceutical, biotechnology, and healthcare industries, including clients that may be competitors of Penterra or that may have interests adverse to Penterra in matters unrelated to this engagement. Nothing in this engagement letter shall be construed to prevent the Firm from representing other clients in matters unrelated to the subject matter of this engagement, provided that such representation does not create a conflict of interest that would be impermissible under the applicable Rules of Professional Conduct.

If a conflict or potential conflict of interest arises during the course of this engagement, the Firm will promptly notify the Company and, if necessary, seek the Company's informed written consent to continue the representation or take such other measures as may be appropriate under the circumstances, including withdrawal from the engagement if the conflict cannot be resolved.

8. Confidentiality

All information and documents provided by the Company to the Firm in connection with this engagement will be treated as confidential and privileged to the fullest extent permitted by law, including under the attorney-client privilege and the work-product doctrine. The Firm recognizes the highly sensitive and proprietary nature of the information it will receive in connection with the CLARION trial, including information relating to the investigational compound penterafenib (PPC-4871), the Company's clinical development strategy, financial terms of the MCTA and related agreements, and other trade secrets and business-sensitive information.

The Firm will not disclose any confidential information to any third party without the Company's prior written consent, except as may be required by law, court order, regulatory mandate, or applicable ethical rules. The Firm will implement appropriate internal safeguards, consistent with its standard confidentiality and information security policies, to protect the Company's confidential information against unauthorized access, use, or disclosure.

The Company's existing obligations under any separate confidentiality or non-disclosure agreement between the Company and Veridian, or between the Company and any other party, are not affected by this engagement letter. The Firm will comply with any reasonable confidentiality protocols or information barriers that the Company may request in connection with this engagement.

9. Document Retention

The Firm will maintain files relating to this engagement in accordance with its standard document retention policies, which are designed to comply with applicable professional responsibility rules and regulatory requirements. The Firm's files may include both paper and electronic documents, correspondence, memoranda, drafts, work product, and other materials generated or received in connection with the engagement.

Upon conclusion or termination of the engagement, the Company may request the return of original documents provided by the Company to the Firm. The Firm will comply with such requests in a reasonable and timely manner. The Firm may retain copies of documents, including work product and internal memoranda, as required or permitted by applicable professional and regulatory requirements, and for the Firm's own internal records. The Firm will continue to treat all retained documents as confidential in accordance with Section 8 of this engagement letter.

The Company is encouraged to maintain its own copies of all documents, correspondence, and materials provided to or received from the Firm during the course of the engagement.

10. Termination of Engagement

Either the Company or the Firm may terminate this engagement at any time upon written notice to the other party. The Company's right to terminate is absolute and may be exercised at any time and for any reason. The Firm's right to terminate is subject to the Firm's obligations under the applicable Rules of Professional Conduct, including the obligation to avoid material prejudice to the client and to provide reasonable notice to the client to allow sufficient time to retain successor counsel.

Upon termination of the engagement, the Company will be responsible for payment of all fees and disbursements incurred through the effective date of termination, in accordance with the fee arrangements set forth in Section 5 of this engagement letter. The Firm will prepare and deliver a final invoice to the Company within thirty (30) days of the effective date of termination.

The Firm will cooperate fully in the orderly transition of the matter to successor counsel designated by the Company, if applicable, including by providing copies of relevant files, documents, and work product (subject to any applicable liens or rights of the Firm under applicable law) and by being reasonably available to respond to questions from successor counsel during the transition period.

Notwithstanding the termination of the engagement, the provisions of this engagement letter relating to confidentiality (Section 8), limitation of liability (Section 11), and governing law (Section 12) shall survive the termination of this engagement and continue in full force and effect.

11. Limitation of Liability

To the fullest extent permitted by applicable law and the applicable Rules of Professional Conduct, the Firm's aggregate liability to the Company arising out of or in connection with this engagement, whether based on contract, tort (including negligence), strict liability, or any other theory of liability, shall not exceed the total amount of fees actually paid by the Company to the Firm for services rendered under this engagement letter. This limitation of liability shall not apply to claims arising from the Firm's gross negligence or willful misconduct in connection with the engagement.

The Company acknowledges that this limitation of liability has been negotiated at arm's length and reflects a reasonable allocation of risk between the parties in light of the fees charged by the Firm and the nature and scope of the engagement. Neither party shall be liable to the other for any indirect, incidental, consequential, special, or punitive damages arising out of or in connection with this engagement, regardless of whether such damages were foreseeable or whether either party has been advised of the possibility of such damages.

12. Governing Law

This engagement letter shall be governed by and construed in accordance with the laws of the State of New York, without regard to its conflicts-of-law principles. Any dispute arising out of or in connection with this engagement letter or the Firm's representation of the Company hereunder shall be subject to the exclusive jurisdiction of the state and federal courts located in the Borough of Manhattan, City of New York, and each party hereby irrevocably consents to the personal jurisdiction of such courts for such purpose.

13. Acceptance and Countersignature

We ask that you review this engagement letter carefully and, if the terms and conditions set forth herein are acceptable to the Company, confirm the Company's acceptance by signing and returning one copy of this letter to the undersigned at the address set forth below. A duplicate original of this engagement letter is enclosed for the Company's records.

The Firm may commence work on this engagement upon receipt of a signed copy of this engagement letter or upon the Company's written or oral authorization to proceed, whichever is earlier. If we do not receive a signed copy of this letter or other authorization to proceed within thirty (30) days of the date hereof, the Firm may, in its discretion, treat this engagement as not having been accepted and close the matter file without further notice.

We are grateful for the opportunity to represent Penterra Pharmaceuticals Corp. in connection with this important matter, and we look forward to working closely with you, Ms. Liang, and your team to bring the CLARION clinical trial agreements to a successful conclusion. Please do not hesitate to contact Miriam Calloway or any member of the engagement team if you have any questions regarding this engagement letter or any other aspect of the representation.

Very truly yours,

CALDERWOOD & HARKNESS LLP

By: ________

Miriam Calloway Partner, Healthcare & Life Sciences Practice Group

Acknowledged:

By: ________

Joel Strauss Partner, Healthcare & Life Sciences Practice Group (Billing Partner)

AGREED AND ACCEPTED:

PENTERRA PHARMACEUTICALS CORP.

By: ________

Name: Nathaniel Briggs, Esq.

Title: Vice President & General Counsel

Date: ________

Please return one executed copy to:

Miriam Calloway, Partner Calderwood & Harkness LLP 280 Park Avenue, 34th Floor New York, NY 10017 miriam.calloway@calderwoodharkness.com

Enclosure: Duplicate original of this engagement letter for Company records

cc:

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

Joel Strauss — Partner (Billing Partner), Calderwood & Harkness LLP

Sean Morrissey — Associate (Lead Associate), Calderwood & Harkness LLP

Professional Category	Hourly Rate Range
Partners	$1,150 – $1,450 per hour
Senior Associates (6+ years)	$850 – $1,050 per hour
Associates (1–5 years)	$650 – $850 per hour
Paralegals and Professional Staff	$350 – $450 per hour

PRIVILEGED AND CONFIDENTIAL
CALDERWOOD & HARKNESS LLP 280 Park Avenue, 34th Floor New York, NY 10017
Telephone: (212) 554-7000 Facsimile: (212) 554-7001 www.calderwoodharkness.com
Additional Office: 101 Carnegie Center, Suite 500 Princeton, NJ 08540 Telephone: (609) 228-3400
March 20, 2023
Nathaniel Briggs, Esq. Vice President & General Counsel Penterra Pharmaceuticals Corp. 200 Biopharma Boulevard, Suite 1400 Princeton, NJ 08540
Dear Mr. Briggs:
1. Introduction and Purpose
Calderwood & Harkness LLP ("C&H" or the "Firm") is pleased to confirm its engagement by Penterra Pharmaceuticals Corp. ("Penterra" or the "Company") for legal representation in connection with the matter described herein. We greatly value our relationship with Penterra and appreciate the confidence the Company has placed in the Firm in selecting us for this significant engagement.
This letter sets forth the terms and conditions under which the Firm will provide legal services to the Company. The purpose of this engagement letter is to define the scope of our representation, the responsibilities of both the Firm and the Company, and the financial and administrative arrangements governing our professional relationship. We ask that you review this letter carefully and, if its terms are acceptable, execute and return the enclosed counterpart copy as described in Section 13 below.
This engagement follows prior discussions between Miriam Calloway, Partner in the Firm's Healthcare & Life Sciences Practice Group, and Rebecca Liang, Esq., Associate General Counsel, Clinical Affairs, of Penterra, as well as subsequent conversations with you regarding the nature and scope of the representation. Based on those discussions and the materials provided by the Company to date, we have developed a thorough understanding of the Company's objectives and the key legal issues involved in the contemplated transactions.
For the Firm's internal records and billing purposes, this engagement has been assigned Firm Matter Number: 1018-00004. We ask that the Company reference this matter number on all correspondence, communications, and payment remittances directed to the Firm in connection with this engagement.
2. Scope of Engagement
The Firm has been retained to represent Penterra in the negotiation, drafting, and finalization of the following agreements and related matters, each as more particularly described below:
(a) Master Clinical Trial Agreement ("MCTA"). The Firm will negotiate and draft a Master Clinical Trial Agreement between Penterra Pharmaceuticals Corp., as sponsor, and Veridian Health Research Network, Inc. ("Veridian"), a Delaware 501(c)(3) corporation headquartered at 750 Research Parkway, 8th Floor, Philadelphia, PA 19104, as site network operator. The MCTA will govern the terms and conditions under which Veridian and its affiliated clinical trial sites will participate in Penterra's Phase III clinical trial conducted under Protocol PPC-4871-III (short title: CLARION — Clinical Assessment of Response with Longitudinal Investigation in ONcology) for the investigational compound penterafenib (PPC-4871), an oral multi-kinase inhibitor targeting advanced hepatocellular carcinoma ("HCC"). The MCTA is expected to address, among other things, the obligations of the sponsor and the site network operator, study conduct requirements, financial terms, data rights, publication rights, indemnification, insurance, regulatory compliance, termination, and dispute resolution.
(b) Site-Network Agreements. The Firm will draft and negotiate individual site joinder agreements (each, a "Site Joinder Agreement") for up to thirty-eight (38) Veridian Network academic medical centers and affiliated research institutions across fourteen (14) states. The Site Joinder Agreements will incorporate by reference the terms of the MCTA and will contain site-specific provisions, including site-level budgets, investigator identification, regulatory and institutional review board ("IRB") approval requirements, and local compliance obligations. The lead sites for the CLARION trial are anticipated to be Graystone University Medical Center, located in Philadelphia, Pennsylvania, and Lakemont Medical Center, located in Chicago, Illinois. The Firm will prioritize the negotiation and finalization of the Site Joinder Agreements for these two lead sites, with remaining site agreements to follow on a rolling basis as Veridian provides site-specific information and regulatory approvals.
(c) Ancillary Agreements. The Firm will draft and/or review ancillary documents relating to the MCTA and the Site Joinder Agreements, including but not limited to: (i) principal investigator agreements; (ii) co-principal investigator agreements; (iii) an intellectual property side letter addressing inventions, discoveries, and data generated during the course of the CLARION trial; (iv) investigator undertaking forms; (v) insurance-related correspondence, including certificates of insurance and evidence of coverage; and (vi) exhibits and schedules to the MCTA, including the study budget, study protocol summary, sample informed consent form annotations, and any other ancillary instruments required to effectuate the MCTA.
(d) Indemnification and Insurance Provisions. The Firm will negotiate the subject-injury indemnification provisions applicable to study subjects participating in the CLARION trial, sponsor and site reciprocal indemnification structures covering third-party claims, and insurance requirements for both sponsor and site-level coverage. This work will include analysis of applicable state law governing clinical trial liability and subject-injury compensation, coordination with the Company's risk management and insurance teams, and preparation of insurance-related exhibits to the MCTA.
(e) Regulatory Compliance Analysis. The Firm will provide legal advice and analysis regarding the regulatory compliance aspects of the MCTA and related agreements, including compliance with the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)) and applicable safe harbors, the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h) and related Open Payments reporting obligations, the Health Insurance Portability and Accountability Act of 1996 ("HIPAA") and its implementing regulations governing the use and disclosure of protected health information in the research context, and the financial disclosure requirements set forth in 21 C.F.R. Part 54 applicable to clinical investigators. For the avoidance of doubt, FDA regulatory strategy, IND maintenance, and related submissions to the U.S. Food and Drug Administration in connection with IND No. 132,847 are being handled separately by Castleton & Hargrove LLP, located at 1100 Connecticut Avenue NW, Suite 900, Washington, DC 20036, and are expressly outside the scope of this engagement.
(f) Closing and Post-Closing. The Firm will prepare closing deliverables, including a closing checklist, closing certificates, secretary's certificates, officer's certificates, signature pages, and any other documents reasonably required to effectuate the execution and delivery of the MCTA and the Site Joinder Agreements. Following closing, the Firm will compile and deliver to the Company a closing binder (in both physical and electronic format) containing fully executed copies of all transaction documents.
Estimated Deal Value. Based on information provided by the Company, the total value of the MCTA and the Site Joinder Agreements is approximately Eighty Million Dollars ($80,000,000), covering site fees, per-patient payments, investigator grants, and operational costs over the CLARION trial's projected forty-two (42) month enrollment period. The Firm understands that the final aggregate value of the agreements may be adjusted based on the number of sites activated, enrollment rates, and protocol amendments during the course of the trial.
Counterparty Counsel. The Firm has been advised that Veridian Health Research Network, Inc. is represented in this matter by Whitmore, Jansen & Callahan LLP, 1500 Market Street, Suite 3200, Philadelphia, PA 19102. The lead partner for Veridian at Whitmore, Jansen & Callahan is Allison Whitmore. The Firm will coordinate all legal communications with Veridian's counsel as appropriate and in accordance with the applicable rules of professional conduct.
Scope Limitations. This engagement is limited to the matters described in subsections (a) through (f) above. Without limiting the generality of the foregoing, this engagement does not include:
(i) FDA regulatory matters, including IND maintenance, regulatory strategy, pre-approval inspection preparation, or communications with the FDA, all of which are being handled by Castleton & Hargrove LLP;
(ii) the separate Master Services Agreement between Penterra and Meridian Contract Research Organization, Inc., which was executed on January 15, 2023, and is outside the scope of this engagement;
(iii) securities law, capital markets advice, or other transactional corporate matters, which are being handled by Ridgeline Capital Markets LLC and such other advisors as the Company may engage from time to time; or
(iv) tax advice, audit matters, or accounting-related services, which are being handled by Townsend Independent Auditors LLP or such other advisors as the Company may engage.
Any expansion of the scope of this engagement will be mutually agreed upon in writing between the Firm and the Company prior to the commencement of any additional work.
3. Engagement Team
The Firm will assign the following attorneys to lead the engagement on behalf of Penterra:
Responsible Partner. Miriam Calloway, Partner, Healthcare & Life Sciences Practice Group. Ms. Calloway will serve as the responsible partner overseeing all aspects of the engagement and will be the primary point of contact for the Company on matters of legal strategy, negotiation, and senior-level client communications. Ms. Calloway has extensive experience in negotiating complex clinical trial agreements and research collaborations on behalf of pharmaceutical sponsors, academic medical centers, and contract research organizations. She can be reached directly at (212) 554-7112 or miriam.calloway@calderwoodharkness.com.
Billing Partner. Joel Strauss, Partner, Healthcare & Life Sciences Practice Group. Mr. Strauss will serve as the billing partner and will be responsible for fee arrangements, invoicing, budget management, and overall matter financial administration. Mr. Strauss has served as billing partner on numerous life sciences transactions and will ensure that the Firm's billing practices comply with the terms set forth in this engagement letter. He can be reached directly at (212) 554-7218 or joel.strauss@calderwoodharkness.com.
Lead Associate. Sean Morrissey, Associate, Healthcare & Life Sciences Practice Group. Mr. Morrissey will serve as the lead associate responsible for day-to-day drafting, negotiation support, redline management, and project management. Mr. Morrissey will coordinate directly with the Company's internal legal team and with counterparty counsel. He can be reached directly at (212) 554-7341 or sean.morrissey@calderwoodharkness.com.
Working Associate. Christopher Aiken, Associate, Healthcare & Life Sciences Practice Group. Mr. Aiken will provide additional support on research memoranda, regulatory compliance analysis (including Anti-Kickback Statute and Sunshine Act analysis), due diligence, and preparation of closing deliverables. He can be reached directly at (212) 554-7429 or christopher.aiken@calderwoodharkness.com.
The Firm may, from time to time, assign additional attorneys, paralegals, or other professional staff to the matter as appropriate to ensure the efficient and timely delivery of legal services. Before assigning any additional attorney to substantive work on this matter, the Firm will consult with the Company's primary legal contact, Rebecca Liang, Esq., Associate General Counsel, Clinical Affairs, to ensure alignment with the Company's expectations regarding staffing and cost management.
4. Client Contact Information
For purposes of this engagement, the Company has designated the following individuals as authorized contacts:
Primary Legal Contact. Rebecca Liang, Esq., Associate General Counsel, Clinical Affairs, Penterra Pharmaceuticals Corp., 200 Biopharma Boulevard, Suite 1400, Princeton, NJ 08540. Telephone: (609) 441-2200 ext. 3147. Email: rliang@penterapharma.com. All substantive legal communications, including draft agreements, redlines, legal memoranda, and negotiation strategy discussions, will be directed to Ms. Liang unless otherwise instructed by the Company. Ms. Liang will serve as the day-to-day legal contact and will be authorized to provide instructions to the Firm on all matters within the scope of this engagement.
Additional Contacts. The following individuals are also authorized contacts for the purposes indicated:
•  Nathaniel Briggs, Esq., Vice President & General Counsel, Penterra Pharmaceuticals Corp. Mr. Briggs will be consulted for approval of strategic legal positions, material concessions in negotiation, and matters requiring authorized signatory approval. Telephone: (609) 441-2200 ext. 3001. Email: nbriggs@penterapharma.com.
•  Samantha Novak, Director, Clinical Contracts, Penterra Pharmaceuticals Corp. Ms. Novak will serve as the Company's point of contact for contracts administration, document logistics, version control, and coordination of site-level information. Telephone: (609) 441-2200 ext. 3289. Email: snovak@penterapharma.com.
The Firm will rely on the instructions and authorizations of the individuals identified above. The Company agrees to notify the Firm promptly in writing if any of the designated contacts change or if additional individuals are authorized to provide instructions on behalf of the Company.
5. Fee Structure and Billing Arrangements
Basis of Fees. The Firm will bill for legal services rendered in connection with this engagement on an hourly basis at the Firm's standard hourly rates then in effect for the attorneys and professional staff assigned to the matter. The Firm's hourly rates reflect the experience, skill, and seniority of the professionals performing the work, as well as the complexity and demands of the matter.
Current Hourly Rates (2023). The Firm's current standard hourly rates for the professionals most likely to be assigned to this matter are as follows:
The specific rate applicable to each professional assigned to the matter will be reflected on the Firm's monthly invoices. The Firm's hourly rates are subject to annual adjustment, typically effective January 1 of each calendar year. The Firm will provide the Company with advance notice of any rate adjustments, which will be communicated in writing no later than thirty (30) days prior to the effective date of the adjustment. The adjusted rates will apply to all services rendered on or after the effective date of the adjustment.
Disbursements and Expenses. In addition to professional fees for attorney and staff time, the Firm will bill the Company for disbursements and out-of-pocket expenses reasonably incurred in connection with the engagement. Such disbursements and expenses may include, but are not limited to:
•  Travel expenses, including airfare, ground transportation, lodging, and meals, incurred in connection with in-person negotiation sessions, site visits, or meetings at the Company's offices, Veridian's offices, or counterparty counsel's offices;
•  Document production and reproduction costs, including photocopying, scanning, and printing charges;
•  Overnight delivery and courier charges;
•  Filing fees and recording charges, if applicable;
•  Outside vendor charges, including but not limited to charges for process servers, legal research databases (to the extent not included in the Firm's overhead), court reporting services, and translation services, if applicable;
•  Long-distance telephone charges and videoconference platform fees, to the extent not included in the Firm's standard overhead; and
•  Such other reasonable and customary disbursements as may be incurred in the ordinary course of the engagement.
The Firm will endeavor to manage disbursements prudently and will obtain the Company's prior approval before incurring any single disbursement or expense item in excess of Five Thousand Dollars ($5,000.00).
Billing Cycle. Invoices will be issued on a monthly basis, typically within fifteen (15) business days following the close of each calendar month. Each invoice will include a detailed description of the services rendered during the billing period, the name and billing rate of the attorney(s) or professional staff performing each task, the time expended on each task (in increments of one-tenth of an hour), and an itemized listing of disbursements and expenses incurred.
Payment Terms. Payment of the Firm's invoices is due within thirty (30) days of the date of the Firm's invoice. The Company agrees to pay interest on past-due amounts at a rate of one percent (1.0%) per month (twelve percent (12%) per annum), or the maximum rate permitted by applicable law, whichever is lower. The Firm reserves the right, upon reasonable notice to the Company, to suspend work on the matter if any invoice remains unpaid for more than sixty (60) days past its due date, subject to the Firm's obligations under applicable rules of professional conduct.
6. Retainer
No retainer or advance deposit is required at the outset of this engagement. The Firm reserves the right to request a retainer or advance deposit against fees and disbursements if circumstances warrant, including but not limited to a material change in the scope or complexity of the engagement, or a pattern of late payment by the Company. Any such request will be made upon reasonable written notice to the Company. Any retainer received will be deposited in the Firm's client trust account and applied against fees and disbursements as invoiced. Any unused portion of the retainer will be returned to the Company upon the conclusion or termination of the engagement.
7. Conflicts of Interest
The Firm has conducted a conflicts check in accordance with its standard internal procedures and the applicable Rules of Professional Conduct, including the New York Rules of Professional Conduct (22 NYCRR Part 1200). Based on the information provided by the Company to date, including the identities of the parties, affiliated entities, and key individuals involved in the CLARION trial and the transactions contemplated by this engagement, no conflicts of interest have been identified that would preclude the Firm from undertaking this representation.
The conflicts check included searches against the following entities and individuals, among others: Veridian Health Research Network, Inc.; Graystone University Medical Center; Lakemont Medical Center; Whitmore, Jansen & Callahan LLP; Allison Whitmore; and such other relevant parties, counterparties, and affiliated persons as were identified by the Company or otherwise known to the Firm.
The Company acknowledges that the Firm is a large, multi-practice law firm that represents numerous clients across a wide range of industries and matters. The Firm represents, and will continue to represent, other clients in the pharmaceutical, biotechnology, and healthcare industries, including clients that may be competitors of Penterra or that may have interests adverse to Penterra in matters unrelated to this engagement. Nothing in this engagement letter shall be construed to prevent the Firm from representing other clients in matters unrelated to the subject matter of this engagement, provided that such representation does not create a conflict of interest that would be impermissible under the applicable Rules of Professional Conduct.
If a conflict or potential conflict of interest arises during the course of this engagement, the Firm will promptly notify the Company and, if necessary, seek the Company's informed written consent to continue the representation or take such other measures as may be appropriate under the circumstances, including withdrawal from the engagement if the conflict cannot be resolved.
8. Confidentiality
All information and documents provided by the Company to the Firm in connection with this engagement will be treated as confidential and privileged to the fullest extent permitted by law, including under the attorney-client privilege and the work-product doctrine. The Firm recognizes the highly sensitive and proprietary nature of the information it will receive in connection with the CLARION trial, including information relating to the investigational compound penterafenib (PPC-4871), the Company's clinical development strategy, financial terms of the MCTA and related agreements, and other trade secrets and business-sensitive information.
The Firm will not disclose any confidential information to any third party without the Company's prior written consent, except as may be required by law, court order, regulatory mandate, or applicable ethical rules. The Firm will implement appropriate internal safeguards, consistent with its standard confidentiality and information security policies, to protect the Company's confidential information against unauthorized access, use, or disclosure.
The Company's existing obligations under any separate confidentiality or non-disclosure agreement between the Company and Veridian, or between the Company and any other party, are not affected by this engagement letter. The Firm will comply with any reasonable confidentiality protocols or information barriers that the Company may request in connection with this engagement.
9. Document Retention
The Firm will maintain files relating to this engagement in accordance with its standard document retention policies, which are designed to comply with applicable professional responsibility rules and regulatory requirements. The Firm's files may include both paper and electronic documents, correspondence, memoranda, drafts, work product, and other materials generated or received in connection with the engagement.
Upon conclusion or termination of the engagement, the Company may request the return of original documents provided by the Company to the Firm. The Firm will comply with such requests in a reasonable and timely manner. The Firm may retain copies of documents, including work product and internal memoranda, as required or permitted by applicable professional and regulatory requirements, and for the Firm's own internal records. The Firm will continue to treat all retained documents as confidential in accordance with Section 8 of this engagement letter.
The Company is encouraged to maintain its own copies of all documents, correspondence, and materials provided to or received from the Firm during the course of the engagement.
10. Termination of Engagement
Either the Company or the Firm may terminate this engagement at any time upon written notice to the other party. The Company's right to terminate is absolute and may be exercised at any time and for any reason. The Firm's right to terminate is subject to the Firm's obligations under the applicable Rules of Professional Conduct, including the obligation to avoid material prejudice to the client and to provide reasonable notice to the client to allow sufficient time to retain successor counsel.
Upon termination of the engagement, the Company will be responsible for payment of all fees and disbursements incurred through the effective date of termination, in accordance with the fee arrangements set forth in Section 5 of this engagement letter. The Firm will prepare and deliver a final invoice to the Company within thirty (30) days of the effective date of termination.
The Firm will cooperate fully in the orderly transition of the matter to successor counsel designated by the Company, if applicable, including by providing copies of relevant files, documents, and work product (subject to any applicable liens or rights of the Firm under applicable law) and by being reasonably available to respond to questions from successor counsel during the transition period.
Notwithstanding the termination of the engagement, the provisions of this engagement letter relating to confidentiality (Section 8), limitation of liability (Section 11), and governing law (Section 12) shall survive the termination of this engagement and continue in full force and effect.
11. Limitation of Liability
To the fullest extent permitted by applicable law and the applicable Rules of Professional Conduct, the Firm's aggregate liability to the Company arising out of or in connection with this engagement, whether based on contract, tort (including negligence), strict liability, or any other theory of liability, shall not exceed the total amount of fees actually paid by the Company to the Firm for services rendered under this engagement letter. This limitation of liability shall not apply to claims arising from the Firm's gross negligence or willful misconduct in connection with the engagement.
The Company acknowledges that this limitation of liability has been negotiated at arm's length and reflects a reasonable allocation of risk between the parties in light of the fees charged by the Firm and the nature and scope of the engagement. Neither party shall be liable to the other for any indirect, incidental, consequential, special, or punitive damages arising out of or in connection with this engagement, regardless of whether such damages were foreseeable or whether either party has been advised of the possibility of such damages.
12. Governing Law
This engagement letter shall be governed by and construed in accordance with the laws of the State of New York, without regard to its conflicts-of-law principles. Any dispute arising out of or in connection with this engagement letter or the Firm's representation of the Company hereunder shall be subject to the exclusive jurisdiction of the state and federal courts located in the Borough of Manhattan, City of New York, and each party hereby irrevocably consents to the personal jurisdiction of such courts for such purpose.
13. Acceptance and Countersignature
We ask that you review this engagement letter carefully and, if the terms and conditions set forth herein are acceptable to the Company, confirm the Company's acceptance by signing and returning one copy of this letter to the undersigned at the address set forth below. A duplicate original of this engagement letter is enclosed for the Company's records.
The Firm may commence work on this engagement upon receipt of a signed copy of this engagement letter or upon the Company's written or oral authorization to proceed, whichever is earlier. If we do not receive a signed copy of this letter or other authorization to proceed within thirty (30) days of the date hereof, the Firm may, in its discretion, treat this engagement as not having been accepted and close the matter file without further notice.
We are grateful for the opportunity to represent Penterra Pharmaceuticals Corp. in connection with this important matter, and we look forward to working closely with you, Ms. Liang, and your team to bring the CLARION clinical trial agreements to a successful conclusion. Please do not hesitate to contact Miriam Calloway or any member of the engagement team if you have any questions regarding this engagement letter or any other aspect of the representation.
Very truly yours,
CALDERWOOD & HARKNESS LLP
By: ________
Miriam Calloway Partner, Healthcare & Life Sciences Practice Group
Acknowledged:
By: ________
Joel Strauss Partner, Healthcare & Life Sciences Practice Group (Billing Partner)
AGREED AND ACCEPTED:
PENTERRA PHARMACEUTICALS CORP.
By: ________
Name: Nathaniel Briggs, Esq.
Title: Vice President & General Counsel
Date: ________
Please return one executed copy to:
Miriam Calloway, Partner Calderwood & Harkness LLP 280 Park Avenue, 34th Floor New York, NY 10017 miriam.calloway@calderwoodharkness.com
Enclosure: Duplicate original of this engagement letter for Company records
cc:
Rebecca Liang, Esq. — Associate General Counsel, Clinical Affairs, Penterra Pharmaceuticals Corp.
Joel Strauss — Partner (Billing Partner), Calderwood & Harkness LLP
Sean Morrissey — Associate (Lead Associate), Calderwood & Harkness LLP
Professional Category | Hourly Rate Range
Partners | $1,150 – $1,450 per hour
Senior Associates (6+ years) | $850 – $1,050 per hour
Associates (1–5 years) | $650 – $850 per hour
Paralegals and Professional Staff | $350 – $450 per hour

PRIVILEGED AND CONFIDENTIAL

CALDERWOOD & HARKNESS LLP

AGREED AND ACCEPTED:

PENTERRA PHARMACEUTICALS CORP.

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