1018-00005 · Penterra Pharmaceuticals Corp · Engagement

engagement-letter-penterra-snda.docx DOCUMENT Real Estate

5 / 12 ← → ✕

CALDERWOOD & HARKNESS LLP 1120 Avenue of the Americas, 32nd Floor New York, New York 10036

July 7, 2022

VIA EMAIL AND FIRST-CLASS MAIL

Lisa Moritani, Esq. General Counsel & Corporate Secretary Penterra Pharmaceuticals Corp. 900 Commons Way, Suite 400 Dralvecen, NJ 08807

Re: Engagement of Calderwood & Harkness LLP — sNDA Labeling Supplement for Velonatib (NDA No. 215-847)

Dear Ms. Moritani:

Thank you for selecting Calderwood & Harkness LLP ("the Firm" or "C&H") to serve as outside regulatory counsel to Penterra Pharmaceuticals Corp. ("Penterra" or the "Company"), a Delaware corporation publicly traded on the New York Stock Exchange under the ticker symbol PTRC. We are pleased to have the opportunity to assist the Company on this important matter, and we appreciate the confidence that you and your colleagues have placed in the Firm. The purpose of this letter is to set forth the terms and conditions of our engagement and to confirm our mutual understanding of the scope of the legal services we will provide, the fees and billing arrangements applicable to the engagement, and certain other matters. We ask that you review this letter carefully and, if it accurately reflects our agreement, sign and return a copy to the Firm in accordance with the instructions set forth below.

1. Scope of Engagement

The Firm is retained to provide legal advice and services to the Company in connection with the preparation, review, and submission of a supplemental New Drug Application ("sNDA") to the United States Food and Drug Administration ("FDA"). The sNDA will seek approval to add a new indication — specifically, the treatment of moderate-to-severe chronic plaque psoriasis in adults who are candidates for systemic therapy or phototherapy — to the currently approved labeling for VELONATIB® (velonatib hydrochloride) tablets, NDA No. 215-847 (the "Labeling Supplement"). The scope of our engagement encompasses the following services:

(a) Advising on FDA regulatory strategy for the sNDA, including the review and assessment of clinical data packages supporting the proposed new indication, and advising on the substance and timing of communications with the FDA, including formal and informal correspondence;

(b) Drafting and reviewing proposed labeling to be included in or submitted with the sNDA, including the United States Prescribing Information ("USPI"), the Patient Package Insert, and the Medication Guide, in each case as may be required or appropriate to support the Labeling Supplement;

(c) Reviewing and advising on FDA meeting requests and related briefing documents, as well as reviewing and commenting on meeting minutes and follow-up correspondence arising from any such meetings;

(d) Advising on compliance with applicable statutory and regulatory requirements governing the submission and approval of sNDAs, including, without limitation, Section 505(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 355(b), and the implementing regulations set forth in Title 21 of the Code of Federal Regulations, Part 314;

(e) Coordinating with the Company's other professional advisors as needed in connection with the Labeling Supplement, including but not limited to the Company's patent counsel, Whitfield & Grange LLP, and its regulatory consultants, Callendar Baines Group LLC, in each case to the extent such coordination is reasonably necessary to advance the objectives of the engagement; and

(f) Such other regulatory advisory services as the Company may from time to time reasonably request of the Firm in connection with the Labeling Supplement.

For the avoidance of doubt, this engagement does not encompass the following matters, each of which is expressly excluded from the scope of the Firm's representation: (i) patent prosecution, patent strategy, or other intellectual property matters relating to Velonatib or any other Company product; (ii) securities disclosure obligations, including filings with the U.S. Securities and Exchange Commission; (iii) commercial launch strategy, marketing, or promotional review; or (iv) any litigation or dispute resolution matters, whether arising in connection with the Labeling Supplement or otherwise. Should the Company desire the Firm's assistance on any such excluded matter, we would be pleased to discuss a separate engagement arrangement at that time.

2. Staffing

The following attorneys will be principally responsible for the services rendered under this engagement:

Joel Strauss, Partner — Mr. Strauss will serve as the Responsible Partner for this matter and will have overall supervisory responsibility for the engagement.

Miriam Calloway, Partner — Ms. Calloway will serve as the Billing Partner and will be available to advise on regulatory strategy and labeling matters as needed.

Sean Morrissey, Associate — Mr. Morrissey will serve as the Lead Associate and will be responsible for the day-to-day management and coordination of the Firm's work on this engagement.

Christopher Aiken, Associate — Mr. Aiken will serve as a Working Associate and will assist in the preparation and review of sNDA-related submissions and correspondence.

The Firm reserves the right to assign additional attorneys, paralegals, or other professional staff to the engagement as may be reasonably necessary to provide timely and effective service to the Company. We will endeavor to keep you informed of any material changes to the staffing of this matter. The Company's primary points of contact for this engagement will be Mr. Strauss and Mr. Morrissey, and all substantive communications from the Company should be directed to one or both of them unless otherwise agreed.

3. Fees and Billing

Professional services rendered in connection with this engagement will be billed at the following blended hourly rates:

These rates are the Firm's current standard rates for this type of engagement and are effective as of the date of this letter. The Firm reserves the right to adjust its standard billing rates from time to time; provided, however, that the Firm will provide the Company with at least sixty (60) days' prior written notice of any such adjustment before applying revised rates to this engagement.

Based on the scope of services described in Section 1 above, and assuming a reasonably anticipated course of interactions with the FDA through submission of the sNDA, the Firm estimates that total professional fees for this engagement will range from $475,000 to $625,000. This estimate is provided for budgetary and planning purposes only and does not constitute a fee cap, fixed fee, or guarantee of the total cost of the engagement. Actual fees may be higher or lower than the estimated range depending on a number of factors, many of which are outside the Firm's control, including the complexity of FDA interactions, the number and nature of revisions to labeling materials, and the extent of coordination required with the Company's other advisors. We will keep you apprised of the status of fees and will alert you promptly if we anticipate that actual fees may materially exceed the upper end of the estimated range.

Invoices for professional services and disbursements will be rendered on a monthly basis and will contain a summary description of the services performed during the applicable billing period. All invoices are due and payable within thirty (30) days of the invoice date. In the event that any invoice remains unpaid more than sixty (60) days after its date, the Firm reserves the right, upon written notice to the Company, to suspend work on the engagement until payment is received.

In addition to professional fees, the Company will be responsible for the reimbursement of all reasonable out-of-pocket disbursements and expenses incurred by the Firm in connection with the engagement. Such disbursements may include, without limitation, travel expenses (airfare, lodging, ground transportation, and meals), filing fees, charges for overnight delivery and courier services, long-distance telecommunications charges, and document production and reproduction costs. All disbursements will be billed at the Firm's actual cost, without markup.

4. Matter Number

This engagement has been assigned the following internal matter number:

1018-00005

We respectfully request that the Company reference this matter number on all correspondence, invoices, payments, and other communications directed to the Firm in connection with this engagement. Use of the matter number will facilitate the accurate allocation of time and expenses and will help ensure the prompt and efficient processing of the Company's communications and payments.

5. Confidentiality

The Firm acknowledges that, in the course of this engagement, it may receive or have access to confidential and proprietary information of the Company, including, without limitation, clinical trial data, preclinical and nonclinical study results, trade secrets, proprietary formulations, regulatory strategy documents, internal communications, and other information that the Company regards as confidential (collectively, "Confidential Information"). The Firm shall maintain the confidentiality of all such Confidential Information in accordance with the Firm's professional obligations under the applicable Rules of Professional Conduct and all other applicable laws, rules, and regulations. The Firm shall not disclose any Confidential Information to any third party without the prior written consent of the Company, except as may be required by law, regulation, or court order, or as may be necessary in the course of providing the services contemplated by this engagement letter to the extent such disclosure is made to Firm personnel who have a need to know such information in connection with the engagement.

6. Conflicts of Interest

Prior to undertaking this engagement, the Firm conducted a thorough review of its current and recent client representations in accordance with its standard conflicts-checking procedures and the applicable Rules of Professional Conduct. Based on that review, the Firm has not identified any conflict of interest that would preclude or materially limit the Firm's ability to represent the Company in connection with the Labeling Supplement.

The Firm is committed to maintaining the integrity of the attorney-client relationship and will continue to monitor for potential conflicts throughout the duration of this engagement. In the event that any actual or potential conflict of interest arises during the course of the representation, the Firm will promptly notify the Company in writing and will take such steps as may be appropriate to address the conflict, including, if necessary, obtaining the Company's informed written consent to the continuation of the representation or, if the conflict cannot be appropriately resolved, withdrawing from the engagement in accordance with the procedures set forth in Section 7 below.

7. Termination

Either party may terminate this engagement at any time, with or without cause, upon thirty (30) days' prior written notice to the other party. In the event of termination by either party, the Company shall remain responsible for payment of all professional fees and disbursements incurred by the Firm through and including the effective date of termination. Upon termination, the Firm will cooperate with the Company and its successor counsel, if any, to effect an orderly transition of the engagement, including the prompt transfer of all client files and work product, subject to the Firm's right to retain copies of such files and work product for its own records in accordance with applicable professional obligations and the Firm's document retention policies. The obligations of confidentiality set forth in Section 5 shall survive any termination of this engagement.

8. Governing Law

This engagement letter and the terms and conditions set forth herein shall be governed by and construed in accordance with the laws of the State of New York, without regard to its conflict-of-laws principles.

We hope that this letter accurately reflects the terms of our engagement. If the foregoing is consistent with your understanding, please so indicate by signing and returning a copy of this letter to the undersigned at your earliest convenience. A countersigned copy may be returned by email (in PDF format) to jstrauss@calderwoodharkness.com, with a hard copy to follow by first-class mail. We look forward to working with you and the Penterra team on this important matter, and we are confident that we can provide the high-quality legal services that the Company expects and deserves.

Please do not hesitate to contact me directly if you have any questions regarding this letter or any aspect of the engagement.

Very truly yours,

CALDERWOOD & HARKNESS LLP

By: ________

Joel Strauss Partner, Healthcare & Life Sciences

AGREED AND ACCEPTED:

PENTERRA PHARMACEUTICALS CORP.

By: ________

Name: Lisa Moritani, Esq.

Title: General Counsel & Corporate Secretary

Date: ________

Timekeeper Level	Hourly Rate
Partners	$1,175.00
Associates	$725.00

CALDERWOOD & HARKNESS LLP 1120 Avenue of the Americas, 32nd Floor New York, New York 10036
July 7, 2022
VIA EMAIL AND FIRST-CLASS MAIL
Lisa Moritani, Esq. General Counsel & Corporate Secretary Penterra Pharmaceuticals Corp. 900 Commons Way, Suite 400 Dralvecen, NJ 08807
Re: Engagement of Calderwood & Harkness LLP — sNDA Labeling Supplement for Velonatib (NDA No. 215-847)
Dear Ms. Moritani:
Thank you for selecting Calderwood & Harkness LLP ("the Firm" or "C&H") to serve as outside regulatory counsel to Penterra Pharmaceuticals Corp. ("Penterra" or the "Company"), a Delaware corporation publicly traded on the New York Stock Exchange under the ticker symbol PTRC. We are pleased to have the opportunity to assist the Company on this important matter, and we appreciate the confidence that you and your colleagues have placed in the Firm. The purpose of this letter is to set forth the terms and conditions of our engagement and to confirm our mutual understanding of the scope of the legal services we will provide, the fees and billing arrangements applicable to the engagement, and certain other matters. We ask that you review this letter carefully and, if it accurately reflects our agreement, sign and return a copy to the Firm in accordance with the instructions set forth below.
1. Scope of Engagement
The Firm is retained to provide legal advice and services to the Company in connection with the preparation, review, and submission of a supplemental New Drug Application ("sNDA") to the United States Food and Drug Administration ("FDA"). The sNDA will seek approval to add a new indication — specifically, the treatment of moderate-to-severe chronic plaque psoriasis in adults who are candidates for systemic therapy or phototherapy — to the currently approved labeling for VELONATIB® (velonatib hydrochloride) tablets, NDA No. 215-847 (the "Labeling Supplement"). The scope of our engagement encompasses the following services:
(a) Advising on FDA regulatory strategy for the sNDA, including the review and assessment of clinical data packages supporting the proposed new indication, and advising on the substance and timing of communications with the FDA, including formal and informal correspondence;
(b) Drafting and reviewing proposed labeling to be included in or submitted with the sNDA, including the United States Prescribing Information ("USPI"), the Patient Package Insert, and the Medication Guide, in each case as may be required or appropriate to support the Labeling Supplement;
(c) Reviewing and advising on FDA meeting requests and related briefing documents, as well as reviewing and commenting on meeting minutes and follow-up correspondence arising from any such meetings;
(d) Advising on compliance with applicable statutory and regulatory requirements governing the submission and approval of sNDAs, including, without limitation, Section 505(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 355(b), and the implementing regulations set forth in Title 21 of the Code of Federal Regulations, Part 314;
(e) Coordinating with the Company's other professional advisors as needed in connection with the Labeling Supplement, including but not limited to the Company's patent counsel, Whitfield & Grange LLP, and its regulatory consultants, Callendar Baines Group LLC, in each case to the extent such coordination is reasonably necessary to advance the objectives of the engagement; and
(f) Such other regulatory advisory services as the Company may from time to time reasonably request of the Firm in connection with the Labeling Supplement.
For the avoidance of doubt, this engagement does not encompass the following matters, each of which is expressly excluded from the scope of the Firm's representation: (i) patent prosecution, patent strategy, or other intellectual property matters relating to Velonatib or any other Company product; (ii) securities disclosure obligations, including filings with the U.S. Securities and Exchange Commission; (iii) commercial launch strategy, marketing, or promotional review; or (iv) any litigation or dispute resolution matters, whether arising in connection with the Labeling Supplement or otherwise. Should the Company desire the Firm's assistance on any such excluded matter, we would be pleased to discuss a separate engagement arrangement at that time.
2. Staffing
The following attorneys will be principally responsible for the services rendered under this engagement:
Joel Strauss, Partner — Mr. Strauss will serve as the Responsible Partner for this matter and will have overall supervisory responsibility for the engagement.
Miriam Calloway, Partner — Ms. Calloway will serve as the Billing Partner and will be available to advise on regulatory strategy and labeling matters as needed.
Sean Morrissey, Associate — Mr. Morrissey will serve as the Lead Associate and will be responsible for the day-to-day management and coordination of the Firm's work on this engagement.
Christopher Aiken, Associate — Mr. Aiken will serve as a Working Associate and will assist in the preparation and review of sNDA-related submissions and correspondence.
The Firm reserves the right to assign additional attorneys, paralegals, or other professional staff to the engagement as may be reasonably necessary to provide timely and effective service to the Company. We will endeavor to keep you informed of any material changes to the staffing of this matter. The Company's primary points of contact for this engagement will be Mr. Strauss and Mr. Morrissey, and all substantive communications from the Company should be directed to one or both of them unless otherwise agreed.
3. Fees and Billing
Professional services rendered in connection with this engagement will be billed at the following blended hourly rates:
These rates are the Firm's current standard rates for this type of engagement and are effective as of the date of this letter. The Firm reserves the right to adjust its standard billing rates from time to time; provided, however, that the Firm will provide the Company with at least sixty (60) days' prior written notice of any such adjustment before applying revised rates to this engagement.
Based on the scope of services described in Section 1 above, and assuming a reasonably anticipated course of interactions with the FDA through submission of the sNDA, the Firm estimates that total professional fees for this engagement will range from $475,000 to $625,000. This estimate is provided for budgetary and planning purposes only and does not constitute a fee cap, fixed fee, or guarantee of the total cost of the engagement. Actual fees may be higher or lower than the estimated range depending on a number of factors, many of which are outside the Firm's control, including the complexity of FDA interactions, the number and nature of revisions to labeling materials, and the extent of coordination required with the Company's other advisors. We will keep you apprised of the status of fees and will alert you promptly if we anticipate that actual fees may materially exceed the upper end of the estimated range.
Invoices for professional services and disbursements will be rendered on a monthly basis and will contain a summary description of the services performed during the applicable billing period. All invoices are due and payable within thirty (30) days of the invoice date. In the event that any invoice remains unpaid more than sixty (60) days after its date, the Firm reserves the right, upon written notice to the Company, to suspend work on the engagement until payment is received.
In addition to professional fees, the Company will be responsible for the reimbursement of all reasonable out-of-pocket disbursements and expenses incurred by the Firm in connection with the engagement. Such disbursements may include, without limitation, travel expenses (airfare, lodging, ground transportation, and meals), filing fees, charges for overnight delivery and courier services, long-distance telecommunications charges, and document production and reproduction costs. All disbursements will be billed at the Firm's actual cost, without markup.
4. Matter Number
This engagement has been assigned the following internal matter number:
1018-00005
We respectfully request that the Company reference this matter number on all correspondence, invoices, payments, and other communications directed to the Firm in connection with this engagement. Use of the matter number will facilitate the accurate allocation of time and expenses and will help ensure the prompt and efficient processing of the Company's communications and payments.
5. Confidentiality
The Firm acknowledges that, in the course of this engagement, it may receive or have access to confidential and proprietary information of the Company, including, without limitation, clinical trial data, preclinical and nonclinical study results, trade secrets, proprietary formulations, regulatory strategy documents, internal communications, and other information that the Company regards as confidential (collectively, "Confidential Information"). The Firm shall maintain the confidentiality of all such Confidential Information in accordance with the Firm's professional obligations under the applicable Rules of Professional Conduct and all other applicable laws, rules, and regulations. The Firm shall not disclose any Confidential Information to any third party without the prior written consent of the Company, except as may be required by law, regulation, or court order, or as may be necessary in the course of providing the services contemplated by this engagement letter to the extent such disclosure is made to Firm personnel who have a need to know such information in connection with the engagement.
6. Conflicts of Interest
Prior to undertaking this engagement, the Firm conducted a thorough review of its current and recent client representations in accordance with its standard conflicts-checking procedures and the applicable Rules of Professional Conduct. Based on that review, the Firm has not identified any conflict of interest that would preclude or materially limit the Firm's ability to represent the Company in connection with the Labeling Supplement.
The Firm is committed to maintaining the integrity of the attorney-client relationship and will continue to monitor for potential conflicts throughout the duration of this engagement. In the event that any actual or potential conflict of interest arises during the course of the representation, the Firm will promptly notify the Company in writing and will take such steps as may be appropriate to address the conflict, including, if necessary, obtaining the Company's informed written consent to the continuation of the representation or, if the conflict cannot be appropriately resolved, withdrawing from the engagement in accordance with the procedures set forth in Section 7 below.
7. Termination
Either party may terminate this engagement at any time, with or without cause, upon thirty (30) days' prior written notice to the other party. In the event of termination by either party, the Company shall remain responsible for payment of all professional fees and disbursements incurred by the Firm through and including the effective date of termination. Upon termination, the Firm will cooperate with the Company and its successor counsel, if any, to effect an orderly transition of the engagement, including the prompt transfer of all client files and work product, subject to the Firm's right to retain copies of such files and work product for its own records in accordance with applicable professional obligations and the Firm's document retention policies. The obligations of confidentiality set forth in Section 5 shall survive any termination of this engagement.
8. Governing Law
This engagement letter and the terms and conditions set forth herein shall be governed by and construed in accordance with the laws of the State of New York, without regard to its conflict-of-laws principles.
We hope that this letter accurately reflects the terms of our engagement. If the foregoing is consistent with your understanding, please so indicate by signing and returning a copy of this letter to the undersigned at your earliest convenience. A countersigned copy may be returned by email (in PDF format) to jstrauss@calderwoodharkness.com, with a hard copy to follow by first-class mail. We look forward to working with you and the Penterra team on this important matter, and we are confident that we can provide the high-quality legal services that the Company expects and deserves.
Please do not hesitate to contact me directly if you have any questions regarding this letter or any aspect of the engagement.
Very truly yours,
CALDERWOOD & HARKNESS LLP
By: ________
Joel Strauss Partner, Healthcare & Life Sciences
AGREED AND ACCEPTED:
PENTERRA PHARMACEUTICALS CORP.
By: ________
Name: Lisa Moritani, Esq.
Title: General Counsel & Corporate Secretary
Date: ________
Timekeeper Level | Hourly Rate
Partners | $1,175.00
Associates | $725.00

CALDERWOOD & HARKNESS LLP 1120 Avenue of the Americas, 32nd Floor New York, New York 10036

VIA EMAIL AND FIRST-CLASS MAIL

CALDERWOOD & HARKNESS LLP

AGREED AND ACCEPTED:

PENTERRA PHARMACEUTICALS CORP.

Record

Parties

Dates

Amounts