CALDERWOOD & HARKNESS LLP 1700 Market Street, Suite 3400 Philadelphia, PA 19103 Tel: (215) 555-8200
Fax: (215) 555-8201
June 9, 2023
VIA ELECTRONIC TRANSMISSION AND SECURE FILE TRANSFER
Kenneth Pratt, Esq. Whitfield Graves LLP One Federal Street, Suite 2600 Boston, MA 02110
Re: Due Diligence Request List — Caliston BioSciences, Inc. / Project Coriander C&H Matter No. 1025-00006
Dear Mr. Pratt:
Calderwood & Harkness LLP serves as independent counsel to the Special Committee of the Board of Directors of Penterra Pharmaceuticals Corp. (NYSE: PPHR) in connection with the proposed acquisition of one hundred percent (100%) of the outstanding equity interests of Caliston BioSciences, Inc., a Delaware corporation ("Caliston" or the "Company"). This engagement is identified internally as C&H Matter Number 1025-00006 and referenced externally under the code name "Project Coriander."
The enclosed Due Diligence Request List is being transmitted on behalf of the Special Committee of the Board of Directors of Penterra Pharmaceuticals Corp. (the "Special Committee"), which is comprised of Diane Prescott (Chair), James Okafor, and Dr. Helen Ng. The Special Committee has been vested with sole and exclusive authority to evaluate, negotiate, and make recommendations to the full Board of Directors with respect to the proposed transaction, and this request list is issued pursuant to that authority.
We respectfully request that all responsive materials be uploaded to the secure virtual data room established for Project Coriander, organized according to the numbered categories set forth in the enclosed request list. We propose a target date of no later than June 28, 2023, for the initial production tranche, which we would expect to include the categories most readily available (e.g., corporate organizational documents, capitalization materials, and financial statements). Remaining items may be produced on a rolling basis thereafter, and we are happy to discuss a mutually agreeable schedule for production of more complex or voluminous materials. We do, however, request that all reasonable efforts be made to produce all responsive documents as expeditiously as possible so as not to delay the Special Committee's evaluation of the proposed transaction.
Please note that this Due Diligence Request List is not intended to be exhaustive. Calderwood & Harkness LLP, on behalf of the Special Committee, expressly reserves the right to submit supplemental requests, follow-up inquiries, and clarification questions as the review progresses and as additional information becomes available. The submission of this initial request list should not be construed as a limitation on the scope of due diligence that the Special Committee may ultimately undertake.
To the extent that Caliston or Whitfield Graves LLP considers any responsive documents or materials to be subject to attorney-client privilege, work product protection, or other confidentiality restrictions, we request that such documents be specifically identified and that a privilege log be provided for any documents withheld from production. The privilege log should include, at a minimum, the date of the document, the author and recipient(s), the general subject matter, and the specific privilege or protection asserted. We further request that any confidentiality restrictions applicable to produced documents (beyond those already established by the executed non-disclosure agreement between the parties) be identified in writing at the time of production.
Should you have any questions regarding the enclosed request list, or should you wish to discuss the proposed timeline for production, please do not hesitate to contact the undersigned or any of the following members of the Calderwood & Harkness LLP team:
Sophie Tremblay (Lead Associate) Tel: (215) 555-8247
Email: stremblay@calderwoodharkness.com
Daniel Obi (Working Associate) Tel: (215) 555-8253
Email: dobi@calderwoodharkness.com
Renata Vasquez (Responsible Partner) Tel: (215) 555-8211
Email: rvasquez@calderwoodharkness.com
We appreciate your cooperation and look forward to working with you and your team to facilitate an efficient and thorough due diligence process.
Very truly yours,
CALDERWOOD & HARKNESS LLP
By: ________
Sophie Tremblay Associate
cc: Renata Vasquez, Esq. (Calderwood & Harkness LLP) Daniel Obi, Esq. (Calderwood & Harkness LLP)
Enclosure: Due Diligence Request List
CONFIDENTIAL — PROJECT CORIANDER
PROJECT CORIANDER — CONFIDENTIAL
DUE DILIGENCE REQUEST LIST
CALISTON BIOSCIENCES, INC.
Prepared by: Calderwood & Harkness LLP Independent Counsel to the Special Committee of the Board of Directors of Penterra Pharmaceuticals Corp. (NYSE: PPHR)
Issued to: Whitfield Graves LLP Counsel to Caliston BioSciences, Inc.
Attention: Kenneth Pratt, Esq.
Date of Issuance: June 9, 2023
GENERAL INSTRUCTIONS
The following general instructions apply to all categories of documents and information requested below. In the event of any conflict between these general instructions and a specific request, the specific request shall control.
1. Temporal Scope. Unless otherwise noted in a specific request, all requests cover the period from the inception of Caliston BioSciences, Inc. (2017) through the present date. Where a request specifies a different time period, documents from the specified period should be produced.
2. Definition of "Caliston" or the "Company." As used herein, "Caliston" or the "Company" refers to Caliston BioSciences, Inc., a Delaware corporation with its principal offices located at 88 Harbor Point Road, Cambridge, MA 02142, together with any subsidiaries, affiliates, or predecessor entities, unless the context clearly indicates otherwise.
3. Most Current Versions. Please provide copies of all documents in their most current form, together with all prior versions, amendments, supplements, restatements, side letters, waivers, consents, exhibits, schedules, and related correspondence that are necessary to understand the complete terms and conditions of each document.
4. Voluminous Productions. Where documents responsive to a particular request are voluminous, an index, summary, or schedule may be provided initially in lieu of the full documents, with the understanding that full documents will be provided promptly upon request by Calderwood & Harkness LLP. The provision of a summary or index shall not be deemed a substitute for full production unless expressly agreed to in writing by Calderwood & Harkness LLP.
5. Materiality Threshold. Requests for "material" items should be interpreted to include any item involving consideration, liability, commitment, or exposure in excess of One Hundred Thousand Dollars ($100,000), unless the context of the specific request indicates a different threshold or unless a different dollar amount is expressly stated.
6. Format of Production. All documents should be produced in native electronic format where possible. Scanned copies of executed agreements are acceptable provided they are legible and complete. Spreadsheets should be produced in native Excel format, and financial models should include all underlying formulas and assumptions.
7. Privilege and Confidentiality. The production of documents pursuant to this request list is subject to the confidentiality provisions of the previously executed non-disclosure agreement between Penterra Pharmaceuticals Corp. and Caliston BioSciences, Inc. Any claims of privilege or work product protection should be handled in accordance with the procedures described in the accompanying cover letter.
CATEGORY 1: CORPORATE ORGANIZATION AND GOOD STANDING
1.1. Certificate of Incorporation (as originally filed, and as amended and/or restated from time to time) of Caliston BioSciences, Inc. filed with the Secretary of State of the State of Delaware, including but not limited to any certificates of amendment, certificates of designation establishing the rights, preferences, and privileges of any series of preferred stock, and any restated certificates of incorporation.
1.2. Current bylaws of Caliston BioSciences, Inc. (as amended and/or restated from time to time), together with all prior versions and any resolutions of the Board of Directors or stockholders adopting, amending, or restating the bylaws.
1.3. Certificates of good standing (or certificates of existence or status, as applicable) from the Secretary of State of the State of Delaware (as the Company's jurisdiction of incorporation) and from the Secretary of the Commonwealth of Massachusetts (as the jurisdiction of the Company's principal office), each dated within thirty (30) days of the date of production. If certificates dated within 30 days are not available at the time of initial production, please produce the most recent certificates available and provide updated certificates as soon as practicable.
1.4. Certificates of qualification, registration, or authority to transact business in all states and foreign jurisdictions in which Caliston is qualified or registered to do business, together with any applications for such qualification or registration and any related annual or biennial reports or filings.
1.5. A complete list of all jurisdictions (domestic and foreign) in which Caliston owns or leases real property, maintains employees or independent contractors, conducts business operations, holds permits or licenses, or otherwise has a physical or operational presence. For each jurisdiction, please indicate the nature of the Company's activities in that jurisdiction and the date on which operations commenced.
1.6. Organizational chart showing all subsidiaries, affiliates, joint ventures, partnerships, and other entities in which Caliston holds a direct or indirect ownership interest, including for each entity: (a) the legal name, (b) the jurisdiction of formation or incorporation, (c) the percentage ownership held by Caliston (directly or indirectly), (d) the names of all directors and officers (or managers and managing members, as applicable), and (e) the nature of the entity's business activities. If Caliston has no subsidiaries, affiliates, or joint ventures, please so confirm in writing.
1.7. Complete minutes of all meetings of the Board of Directors and any committees thereof (including, without limitation, audit committees, compensation committees, nominating committees, scientific advisory committees, and any special committees) from the Company's inception in 2017 through the present date. This request includes all written consents in lieu of meetings adopted by the Board of Directors or any committee thereof, as well as all board packages, presentations, and materials distributed to directors in connection with such meetings or written consents.
1.8. Complete minutes of all meetings of stockholders of Caliston from inception through the present date, including all written consents in lieu of meetings adopted by the stockholders. This request includes all notices of stockholder meetings, proxy statements (if any), and materials distributed to stockholders in connection with such meetings or written consents.
1.9. A list of all current directors and officers of Caliston, including for each individual: (a) full legal name, (b) title and position(s) held, (c) date of initial appointment or election, (d) current term of office, and (e) committee memberships (if applicable). Please also provide a list of all former directors and officers since inception, with the dates of their respective service.
1.10. The name and contact information for Caliston's registered agent in the State of Delaware (understood to be Pemberton Industries, 251 Little Falls Drive, Wilmington, DE 19808) and in any other jurisdiction in which the Company is qualified or registered to do business. Please also provide copies of any registered agent appointment agreements or service contracts currently in effect.
1.11. All management agreements, advisory agreements, consulting agreements, professional services agreements, or similar arrangements between Caliston and any of its directors, officers, affiliates, or any entity owned or controlled by any director, officer, or affiliate. This request includes any agreements for the provision of management, administrative, strategic, or other services, regardless of whether such agreements are oral or written, formal or informal.
1.12. Please confirm that the Company's Employer Identification Number (EIN) issued by the Internal Revenue Service is 84-4219063, and provide a copy of the IRS EIN assignment letter (Form CP 575 or equivalent) if available.
CATEGORY 2: CAPITALIZATION
2.1. A current, complete, and fully diluted capitalization table showing all outstanding shares of capital stock (common and preferred, by series), warrants, options, convertible securities, and all other equity or equity-linked interests of Caliston, on both an as-outstanding and as-converted/as-exercised basis. The capitalization table should identify the name of each holder, the class and series of equity held, the number of shares or units held, the issue date, the purchase or exercise price paid or payable, and the percentage of total equity represented on a fully diluted basis.
2.2. With respect to the following equity interests, please specifically identify each holder and provide all supporting documentation, including stock purchase agreements, subscription agreements, stock certificates (or evidence of book-entry issuance), and any related correspondence:
(a) Dr. Marcus Hale — reported to hold an approximately 28.5% equity interest, acquired through personal investment of approximately $42 million across the Seed, Series A, and Series B financing rounds;
(b) Ridgeline Ventures, LP — reported to hold an approximately 22.3% equity interest, acquired as the lead investor in the Series C financing round;
(c) Meridian Life Sciences Fund III, LP — reported to hold an approximately 18.7% equity interest, acquired as the lead investor in the Series B financing round; and
(d) Caliston Founders / Management Pool — reported to hold an aggregate of approximately 30.5% of the Company's equity, comprised of the holdings of Dr. Nadia Sorensen (CEO, approximately 14.2%), Dr. Raj Malhotra (CSO, approximately 9.8%), and other founders and management team members (approximately 6.5%).
Please confirm the accuracy of the foregoing ownership percentages, or provide corrected figures, and produce all documents evidencing such ownership.
2.3. All stock purchase agreements, subscription agreements, promissory notes, closing certificates, legal opinions, and other documentation pursuant to which equity securities were issued in each of the following financing rounds: (a) the Seed round, (b) the Series A round, (c) the Series B round, and (d) the Series C round. We understand that total equity capital raised to date is approximately $347 million — please confirm this figure or provide the correct aggregate amount, together with a breakdown by round.
2.4. Complete closing documentation for the Series C financing round (closed in or about October 2021, at a reported post-money valuation of $680 million), including without limitation: (a) the term sheet or letter of intent, (b) the Series C Preferred Stock Purchase Agreement, (c) the Amended and Restated Certificate of Incorporation (including the certificate of designation for Series C Preferred Stock), (d) all closing certificates and officer's certificates, (e) the legal opinion delivered at closing, (f) all closing conditions checklists, and (g) any side letters or supplemental agreements entered into in connection with the closing.
2.5. All stockholders' agreements, voting agreements, co-sale agreements (or rights of co-sale agreements), rights of first refusal agreements, and investor rights agreements (including amended and restated versions) to which Caliston or any of its stockholders is a party, together with all amendments, waivers, consents, and supplements thereto. This request includes any schedules of key holders, schedules of investors, and notices delivered pursuant to such agreements.
2.6. All equity incentive plans, stock option plans, restricted stock plans, restricted stock unit plans, stock appreciation rights plans, phantom equity plans, profit interest plans, and any other equity-based or equity-linked compensation plans adopted by Caliston (collectively, "Equity Plans"), together with: (a) all form award agreements (including form stock option agreements, form restricted stock purchase agreements, and form RSU award agreements) used under each Equity Plan, (b) all board and stockholder resolutions authorizing the adoption of each Equity Plan and any amendments thereto, (c) the total number of shares authorized for issuance under each Equity Plan, and (d) a complete schedule of all outstanding awards (both vested and unvested) by holder, including for each award the grant date, vesting schedule, exercise price (if applicable), number of shares subject to the award, and vesting status as of the most recent practicable date.
2.7. All agreements granting registration rights, demand registration rights, piggyback registration rights, S-3 registration rights, anti-dilution protections (including broad-based weighted average and full ratchet anti-dilution), preemptive rights, rights of first offer, or rights of first refusal with respect to future issuances of equity securities. Please identify which agreements would survive the consummation of the proposed transaction with Penterra.
2.8. All agreements, instruments, or provisions restricting the transfer, sale, assignment, pledge, or other disposition of any securities of Caliston, including lock-up agreements, market standoff provisions, right of first refusal provisions contained in any stockholders' agreement or the Company's bylaws or certificate of incorporation, and any contractual restrictions on transfer contained in award agreements under the Equity Plans.
2.9. A schedule of all shares of Caliston capital stock issued in connection with the exercise of stock options, warrants, or other convertible securities during the past three years, including for each issuance the date of exercise, the identity of the holder, the number of shares issued, the exercise price paid, and the class and series of shares issued.
2.10. All documentation relating to board observer rights granted to any person or entity, including specifically any agreement, resolution, or other instrument granting Dr. Marcus Hale a board observer seat (understood to have been in effect since 2018). Please also identify any other persons or entities that hold or have held board observer rights, and provide the applicable documentation.
2.11. Copies of all independent third-party valuations of Caliston's equity, including valuations prepared for purposes of Section 409A of the Internal Revenue Code, and any other appraisals, fairness opinions, or valuation analyses performed in the last three years. For each valuation, please identify the valuation firm, the date of the valuation, the valuation methodology employed, and the concluded fair market value per share.
CATEGORY 3: MATERIAL CONTRACTS
3.1. All contracts, agreements, commitments, purchase orders, and other binding arrangements to which Caliston is a party or by which it is bound (including any oral agreements that have been documented in writing) that involve aggregate consideration, payments, receipts, or potential liability in excess of $100,000 over the life of the agreement, or that have a remaining term exceeding one (1) year and are not terminable by Caliston on ninety (90) days' or less notice without penalty, premium, or other adverse consequence.
3.2. All license agreements (both in-licenses and out-licenses) relating to intellectual property of any kind, including patents, patent applications, know-how, trade secrets, trademarks, copyrights, and software. This request includes any agreements with universities, academic medical centers, research institutions, government agencies, or other third parties pursuant to which intellectual property rights have been licensed to or by Caliston.
3.3. All collaboration agreements, joint development agreements, co-promotion agreements, co-development agreements, co-commercialization agreements, and strategic alliance agreements, including any term sheets or letters of intent relating to potential collaborations under active negotiation.
3.4. All agreements with contract research organizations ("CROs"), clinical research organizations, site management organizations, central laboratories, and other service providers engaged in connection with Caliston's clinical trial programs, including master service agreements, work orders, task orders, and statements of work. This request also includes all clinical trial service agreements and clinical trial management agreements.
3.5. All agreements with contract development and manufacturing organizations ("CDMOs"), contract manufacturing organizations ("CMOs"), fill-finish providers, packaging and labeling providers, and other entities engaged in the development, manufacture, testing, or supply of Caliston's product candidates, including CLT-4019, CLT-5227, and CLT-6034. Please include all quality agreements, supply agreements, manufacturing service agreements, and any related technical transfer agreements.
3.6. All agreements with vendors, suppliers, consultants, or other service providers (not otherwise covered by Requests 3.2 through 3.5) involving annual payments or commitments in excess of $50,000, including but not limited to agreements for laboratory equipment and supplies, information technology services, facilities management, legal services, accounting services, and investor relations.
3.7. All agreements containing change-of-control provisions, anti-assignment clauses, consent-to-assignment requirements, or any other provisions that may be triggered, implicated, or affected by the proposed acquisition of Caliston by Penterra Pharmaceuticals Corp. For each such agreement, please identify (a) the specific provision at issue, (b) whether the provision requires notice, consent, or approval from any third party, and (c) the consequences of a failure to obtain any required consent or approval (e.g., termination rights, acceleration, repricing, or modification of terms).
3.8. All agreements containing non-competition covenants, non-solicitation covenants, exclusivity provisions, most-favored-nation clauses, or similar restrictive provisions that could limit Caliston's or the combined entity's ability to conduct business following the consummation of the proposed transaction.
3.9. All agreements, arrangements, or transactions between Caliston and any related party, affiliate, director, officer, stockholder, or immediate family member of any director, officer, or stockholder of Caliston. This request specifically includes, without limitation, all agreements with Dr. Marcus Hale and any entities owned or controlled by Dr. Hale, as well as any agreements with Ridgeline Ventures, LP, Meridian Life Sciences Fund III, LP, or any partner, principal, or affiliate thereof.
3.10. All guarantees, sureties, indemnification agreements, contribution agreements, and similar arrangements pursuant to which Caliston has guaranteed or agreed to indemnify or hold harmless any third party, or pursuant to which any third party has guaranteed or agreed to indemnify or hold harmless Caliston.
3.11. All government contracts, cooperative agreements, grants, subcontracts, and other agreements with any federal, state, or local governmental entity, including any grants or awards from the National Institutes of Health ("NIH"), the National Science Foundation, the Biomedical Advanced Research and Development Authority ("BARDA"), or any other federal agency. Please include all terms and conditions applicable to such awards, including any Bayh-Dole Act obligations or restrictions on the use of funded intellectual property.
3.12. All agreements relating to indebtedness for borrowed money, including promissory notes, credit agreements, revolving credit facilities, term loan agreements, convertible notes, venture debt facilities, equipment financing arrangements, and any related security agreements, pledge agreements, guarantees, or subordination agreements. Please include all amendments, modifications, waivers, and consents relating to such agreements.
3.13. All letters of intent, memoranda of understanding, term sheets, expressions of interest, or similar non-binding or partially-binding agreements relating to potential transactions, partnerships, collaborations, licensing arrangements, or other strategic initiatives (other than the proposed merger with Penterra Pharmaceuticals Corp.), whether currently active, expired, or terminated, entered into during the past three years.
CATEGORY 4: INTELLECTUAL PROPERTY
4.1. A comprehensive schedule of all patents and patent applications (United States and foreign) owned or co-owned by Caliston, including for each patent or application: (a) the patent or application number, (b) the title of the invention, (c) the filing date, (d) the issue date (if issued), (e) the expiration date (including any patent term adjustments or extensions), (f) the jurisdiction, (g) the current prosecution status, (h) the named inventor(s), and (i) the assignee of record. This schedule should specifically and separately identify all patents and patent applications within the following portfolios:
(i) CLT-4019 patent portfolio — relating to the Company's selective CDK4/6 inhibitor compound and its use in the treatment of HR+/HER2– metastatic breast cancer, including composition of matter patents, method of treatment patents, formulation patents, and any related divisional, continuation, continuation-in-part, or provisional applications;
(ii) CLT-5227 patent portfolio — including all patents and applications relating to the CLT-5227 compound, its synthesis, formulations, and therapeutic uses; and
(iii) CLT-6034 patent portfolio — including all patents and applications relating to the CLT-6034 compound, its synthesis, formulations, and therapeutic uses.
4.2. A comprehensive schedule of all trademarks, trademark applications, trade names, service marks, and domain names (United States and foreign) owned, applied for, or used by Caliston in the conduct of its business, including for each mark: (a) the mark, (b) the registration or application number, (c) the filing date, (d) the registration date (if registered), (e) the jurisdiction, (f) the classes of goods or services covered, and (g) the current status.
4.3. A schedule of all copyrights and copyright registrations owned by or registered to Caliston, including for each registration: (a) the title of the work, (b) the registration number, (c) the date of registration, and (d) the nature of the work (e.g., software, scientific publications, marketing materials).
4.4. Copies of all invention assignment agreements, proprietary information and inventions agreements, confidential information agreements, work-for-hire agreements, and similar agreements with all current and former employees, consultants, scientific advisors, and independent contractors of Caliston. Please identify any individuals who have not executed such agreements.
4.5. Copies of all intellectual property assignment agreements documenting the complete chain of title from the original inventors and founders — including Dr. Nadia Sorensen, Dr. Raj Malhotra, and any other co-founders or co-inventors — to Caliston, including any assignments from universities, academic institutions, prior employers, or other entities. Please also provide any confirmatory assignments or supplemental assignment documents that have been executed.
4.6. All license agreements (in-bound and out-bound) pertaining to patents, patent applications, know-how, trade secrets, software, data, or other intellectual property, to the extent not previously produced in response to Request 3.2. This request includes any cross-license agreements, covenant-not-to-sue agreements, and settlement licenses arising from prior intellectual property disputes.
4.7. Any freedom-to-operate opinions, non-infringement opinions, patentability opinions, invalidity analyses, or other intellectual property opinions or assessments prepared for Caliston by outside patent counsel or other third parties, to the extent that Caliston is willing to produce such documents without waiving attorney-client privilege or work product protection. If Caliston intends to assert privilege over any such documents, please include them on the privilege log.
4.8. All correspondence with the United States Patent and Trademark Office ("USPTO") or any foreign patent or trademark office during the last three years, including all office actions, responses to office actions, restriction requirements, election of species, notices of allowance, notices of publication, certificates of correction, requests for continued examination, petitions, and any inter partes or post-grant proceedings.
4.9. A description of all intellectual property-related litigation, oppositions, inter partes review proceedings, post-grant review proceedings, interferences, derivation proceedings, reexamination proceedings, or other disputes involving any intellectual property owned by, licensed to, or asserted against Caliston, whether pending, threatened, or resolved during the past five years. For each such matter, please provide: (a) the parties involved, (b) the forum, (c) the subject matter, (d) the current status, and (e) copies of all material pleadings, decisions, and settlement documentation.
4.10. A description of all material trade secrets and proprietary know-how owned or controlled by Caliston, including manufacturing processes, formulations, clinical data, research data, customer lists, vendor lists, and business strategies. Please also describe the measures Caliston has implemented to protect the confidentiality of its trade secrets and proprietary information, including physical security, information technology security, access controls, confidentiality agreements, and employee training programs.
4.11. All agreements with third parties granting rights in or to Caliston intellectual property, including outbound licenses, sublicenses, options to license, and rights of first negotiation or first refusal with respect to intellectual property. Please identify the licensee, the licensed rights, the territory, the field of use, and the key financial terms (including royalties, milestones, and upfront payments).
4.12. Copies of any prior art searches, patent landscape analyses, competitive intelligence reports, or market analyses relating to the CDK4/6 inhibitor space, the HR+/HER2– metastatic breast cancer treatment landscape, or any other therapeutic area relevant to Caliston's pipeline programs (CLT-4019, CLT-5227, and CLT-6034), to the extent such documents can be produced without waiving privilege.
CATEGORY 5: REGULATORY AND FDA MATTERS
5.1. All Investigational New Drug ("IND") applications filed by Caliston with the United States Food and Drug Administration ("FDA"), including specifically IND No. 158429 filed for CLT-4019 (filed in or about March 2020), together with all amendments, supplements, annual reports, information amendments, safety reports, and other submissions made to the FDA in connection with such IND applications. If Caliston has filed IND applications for any other product candidates (including CLT-5227 or CLT-6034), please produce those as well.
5.2. All correspondence between Caliston and the FDA, including: (a) pre-IND meeting request letters and meeting minutes, (b) end-of-Phase 1 meeting requests and meeting minutes, (c) end-of-Phase 2 meeting requests and meeting minutes, (d) Type A, Type B, and Type C meeting requests and meeting minutes, (e) clinical hold letters and responses thereto, (f) information request letters and responses thereto, (g) deficiency letters and responses thereto, (h) FDA acknowledgment letters, and (i) any other substantive correspondence with the FDA or any division thereof.
5.3. Clinical trial protocols, protocol amendments, and protocol deviations for all ongoing and completed clinical trials sponsored by Caliston, including specifically the Phase 2b clinical trial for CLT-4019 in HR+/HER2– metastatic breast cancer (for which topline data is expected in Q4 2023). Please include statistical analysis plans, clinical study reports (for completed studies), and interim data analyses (if available and to the extent not subject to DSMB confidentiality restrictions).
5.4. All clinical trial agreements, clinical trial site agreements, investigator agreements, and related budgets entered into with investigational sites, principal investigators, and sub-investigators for each of Caliston's clinical trial programs.
5.5. All Data Safety Monitoring Board ("DSMB") charters, DSMB membership rosters, DSMB meeting minutes, DSMB recommendations, and DSMB reports for each of Caliston's clinical trial programs. To the extent that certain DSMB deliberations are subject to confidentiality restrictions, please identify such restrictions and advise on the availability of unblinded versus blinded data.
5.6. A current summary of clinical trial enrollment status for each of Caliston's ongoing clinical trials, including: (a) the total number of subjects enrolled to date, (b) the target enrollment, (c) the number of investigational sites activated, (d) the number of investigational sites under contract but not yet activated, (e) the anticipated enrollment completion date, (f) the anticipated date for last patient/last visit, and (g) the expected date for availability of topline data.
5.7. All Institutional Review Board ("IRB") and Ethics Committee approvals, amendments, continuing reviews, and termination notices for each of Caliston's clinical trial programs, including initial approvals, annual renewals, and protocol amendment approvals.
5.8. Copies of all adverse event reports, serious adverse event reports, individual case safety reports ("ICSRs"), suspected unexpected serious adverse reaction ("SUSAR") reports, expedited safety reports, and annual safety reports filed by Caliston with the FDA or any other regulatory authority. Please also provide a tabular summary of all serious adverse events reported across Caliston's clinical programs.
5.9. All regulatory filings, applications, submissions, and correspondence with foreign regulatory authorities, including the European Medicines Agency ("EMA"), the United Kingdom Medicines and Healthcare products Regulatory Agency ("MHRA"), Health Canada, the Japanese Pharmaceuticals and Medical Devices Agency ("PMDA"), and any other foreign regulatory body, if any. If Caliston has not made any foreign regulatory filings, please confirm.
5.10. Any FDA Warning Letters, untitled letters, Form 483 observations, establishment inspection reports ("EIRs"), consent decrees, injunctions, debarment orders, or other enforcement actions issued to or involving Caliston, its facilities, or any of its contract manufacturers, CROs, or clinical trial sites. If none, please confirm.
5.11. All registrations with the United States Drug Enforcement Administration ("DEA") and any state pharmacy, drug distributor, or controlled substance licenses, to the extent applicable to Caliston's operations or product candidates. If not applicable, please confirm.
5.12. All documentation relating to any orphan drug designation, fast track designation, breakthrough therapy designation, accelerated approval pathway, priority review designation, or any other special regulatory designation or pathway applied for or granted by the FDA or any foreign regulatory authority with respect to any of Caliston's product candidates.
5.13. A management-prepared narrative description of the anticipated regulatory pathway for CLT-4019 from the current Phase 2b stage through NDA submission and anticipated approval, including: (a) the anticipated design and timing of any additional clinical trials (e.g., pivotal Phase 3 trial), (b) pre-submission meeting strategy, (c) the expected NDA submission date, (d) the anticipated review timeline, (e) any planned pediatric studies or post-marketing commitments, and (f) any regulatory risks or uncertainties identified by management or regulatory counsel.
5.14. A description of any regulatory considerations, notifications, or approvals required in connection with a change of control of the IND sponsor, including any requirements to notify the FDA or other regulatory authorities, transfer or amend the IND, or obtain consent from clinical trial investigators, IRBs, or regulatory bodies. Please include an assessment of any potential impact on ongoing clinical trials resulting from the change of control.
CATEGORY 6: LITIGATION AND DISPUTES
6.1. A complete schedule of all pending or threatened litigation, arbitration, mediation, administrative proceedings, or other dispute resolution proceedings to which Caliston is or may become a party (whether as plaintiff, defendant, claimant, respondent, intervenor, or otherwise), including for each matter: (a) the case name and number, (b) the forum, (c) the parties involved, (d) a brief description of the claims and defenses, (e) the amount in controversy or damages sought, (f) the current status, and (g) an assessment of the potential exposure or liability.
6.2. Copies of all demand letters, cease-and-desist letters, threat letters, or other pre-litigation correspondence received by or sent by Caliston during the past five years, including any communications from or to competitors, licensors, licensees, former employees, stockholders, governmental agencies, or other third parties asserting or threatening claims against Caliston or its intellectual property.
6.3. Copies of all settlement agreements, consent orders, consent decrees, judgments, and releases to which Caliston is a party or by which it is bound, together with any related payment schedules, compliance undertakings, or ongoing obligations.
6.4. A description of any ongoing or prior governmental investigations, inquiries, subpoenas, civil investigative demands, or enforcement actions involving Caliston or any of its current or former directors, officers, or employees (in their capacity as such), including any investigations by the Department of Justice, the SEC, the FTC, the HHS Office of Inspector General, or any state attorney general.
6.5. Copies of all outstanding orders, injunctions, decrees, stipulations, or judgments of any court, arbitral tribunal, or governmental agency that are currently binding on Caliston or that restrict or affect the conduct of its business.
6.6. A description of any material disputes (whether or not resulting in formal proceedings) with employees, former employees, consultants, vendors, suppliers, licensors, licensees, collaborators, clinical trial investigators, or any other third party, including any disputes that are in an informal negotiation or pre-litigation stage.
6.7. Copies of any legal opinions, risk assessments, litigation reserve analyses, or similar documents prepared by inside or outside counsel regarding pending or threatened claims or potential liabilities, to the extent that Caliston is willing to produce such documents without waiving attorney-client privilege or work product protection. If Caliston intends to assert privilege over any such documents, please include them on the privilege log.
CATEGORY 7: EMPLOYMENT MATTERS
7.1. Current total employee headcount (please confirm whether the Company's current headcount is approximately 94 employees as of the date hereof) and a detailed organizational chart showing all departments, functional groups, and reporting relationships. Please identify all employees by name, title, department, location, date of hire, and employment status (full-time, part-time, or temporary).
7.2. Copies of all employment agreements, offer letters, employment term sheets, and independent contractor agreements for all executive officers and key employees, including without limitation:
(a) Dr. Nadia Sorensen, Chief Executive Officer;
(b) Dr. Raj Malhotra, Chief Scientific Officer;
(c) Dr. Evan Whitmore, Head of Clinical Development; and
(d) any other individuals serving in a VP-level or above capacity, or any individuals identified by management as key to the Company's operations.
7.3. Copies of all non-competition agreements, non-solicitation agreements, confidentiality and non-disclosure agreements, and restrictive covenant agreements with all current and former employees and independent contractors. Please specifically identify any agreements that may restrict the ability of any Caliston employee to continue employment with the surviving entity following the proposed transaction.
7.4. Copies of all employee handbooks, codes of conduct, codes of ethics, anti-harassment policies, whistleblower policies, and other written employment policies and procedures currently in effect, together with all prior versions in effect during the past three years and evidence of employee acknowledgment of receipt.
7.5. Copies of all bonus plans, incentive compensation plans, management incentive plans, commission arrangements, retention bonus agreements, stay bonus agreements, and transaction bonus agreements currently in effect or that have been in effect during the past three years. Please include all plan documents, summary descriptions, and schedules of payments made or accrued under such plans.
7.6. A complete schedule of all employees and other service providers who are eligible for or entitled to receive change-of-control payments, severance payments, acceleration of equity vesting, enhanced benefits, or any other form of compensation or benefit that may be triggered by the consummation of the proposed acquisition by Penterra Pharmaceuticals Corp. For each such individual, please provide: (a) the applicable agreement or plan provision, (b) the estimated amount of the payment or benefit, and (c) an analysis of whether any such payment may constitute an "excess parachute payment" within the meaning of Sections 280G and 4999 of the Internal Revenue Code. Please identify any potential "parachute payment" issues and provide copies of all Section 280G analyses or calculations that have been prepared.
7.7. Copies of all collective bargaining agreements, union contracts, or other labor agreements, and all correspondence with any labor union, works council, or employee representative body. If Caliston has no collective bargaining agreements and has not been the subject of any union organizing activity, please so confirm.
7.8. A schedule of all employee benefit plans (as defined in Section 3(3) of ERISA) and all other benefit arrangements, programs, and policies maintained, sponsored, or contributed to by Caliston for the benefit of its employees or their beneficiaries, including health insurance plans, dental and vision plans, retirement plans (including any 401(k) plan), pension plans, disability insurance plans, life insurance plans, flexible spending accounts, health savings accounts, employee assistance programs, tuition reimbursement programs, and any other fringe benefit programs. For each plan, please provide copies of the plan document, summary plan description, most recent Form 5500 filing (if applicable), and any compliance testing results.
7.9. A description of any pending or threatened employment-related claims, lawsuits, charges, complaints, or proceedings, including without limitation: (a) charges filed with the Equal Employment Opportunity Commission ("EEOC") or any state or local fair employment agency, (b) complaints filed with the Occupational Safety and Health Administration ("OSHA"), (c) wage-and-hour claims or class action lawsuits, (d) workers' compensation claims, (e) whistleblower complaints (including those filed under the Sarbanes-Oxley Act, the Dodd-Frank Act, or any state whistleblower statute), and (f) claims alleging wrongful termination, discrimination, harassment, or retaliation.
7.10. All records and documentation relating to Form I-9 compliance, work authorization verification, and immigration sponsorship for any employees or prospective employees requiring immigration sponsorship (including H-1B, L-1, O-1, TN, or other visa categories), including a list of all employees currently sponsored by Caliston for temporary or permanent immigration status.
7.11. Copies of all consulting agreements, advisory agreements, scientific advisory board agreements, and clinical advisory board agreements with any individual or entity providing advisory, consulting, or scientific advisory services to Caliston, together with a list of all current members of any scientific advisory board or clinical advisory board.
CATEGORY 8: TAX MATTERS
8.1. Complete copies of all federal, state, and local income tax returns (including all schedules, attachments, and supporting workpapers) filed by Caliston for the last three fiscal years (FY2020, FY2021, and FY2022; fiscal year ending December 31). If Caliston files any combined, consolidated, or unitary returns with any other entity, please produce those returns as well.
8.2. All correspondence between Caliston and the Internal Revenue Service or any state or local taxing authority, including audit notices, examination letters, revenue agent reports, notices of proposed adjustment, notices of deficiency, closing agreements, settlement agreements, and any other formal or informal communications relating to tax examinations or assessments.
8.3. A schedule of all net operating losses ("NOLs"), net operating loss carryforwards, tax credit carryforwards (including federal and state research and development credits under Section 41 of the Internal Revenue Code), capital loss carryforwards, and any other tax attributes available to Caliston, including the year in which each attribute was generated, the amount remaining, and the expiration date (if applicable).
8.4. Copies of all tax-sharing agreements, tax indemnification agreements, tax allocation agreements, and any other agreements relating to the allocation, apportionment, or sharing of tax liabilities or tax benefits between Caliston and any other entity, including any agreements with stockholders or affiliates.
8.5. Copies of any private letter rulings, technical advice memoranda, determination letters, closing agreements, or other rulings or guidance obtained by Caliston from the IRS or any state or local tax authority.
8.6. A description of any audits, assessments, deficiencies, or disputes relating to sales and use taxes, payroll taxes, excise taxes, personal property taxes, or any other non-income taxes, together with copies of all related correspondence and assessment notices.
8.7. Documentation relating to any transfer pricing arrangements, intercompany pricing policies, or cost-sharing agreements between Caliston and any affiliates, subsidiaries, or related entities, to the extent applicable. If not applicable, please confirm.
8.8. Any analysis prepared by Caliston or its tax advisors under Sections 382 and 383 of the Internal Revenue Code regarding potential limitations on the utilization of net operating losses, net operating loss carryforwards, or tax credits following an "ownership change" (as defined in Section 382(g)), including any analysis of whether prior equity financing rounds constituted ownership changes and any analysis of the potential impact of the proposed acquisition by Penterra on the Company's ability to utilize its tax attributes.
8.9. Documentation relating to any elections made under Section 83(b) of the Internal Revenue Code by any founder, employee, consultant, or other equity holder of Caliston, including copies of the election statements filed with the IRS and evidence of timely filing.
CATEGORY 9: REAL PROPERTY
9.1. Copies of all leases, subleases, licenses to occupy, amendments, extensions, renewals, and side letters for all real property currently or formerly occupied or used by Caliston, including specifically the lease for the Company's principal office located at 88 Harbor Point Road, Cambridge, MA 02142. For each lease, please identify the landlord, the premises, the lease term (including any renewal options), the current annual rent, any rent escalation provisions, and any security deposits or letters of credit provided.
9.2. If Caliston owns any real property, please provide copies of all deeds, title reports, title commitments, title insurance policies, surveys, and any other documents evidencing ownership. If Caliston does not own any real property, please confirm.
9.3. A schedule of all locations where Caliston conducts operations, stores materials (including clinical trial materials, drug substances, or drug products), or maintains equipment, including the address of each location, the nature of operations conducted there, and whether the space is leased, owned, or used under a license or other arrangement.
9.4. Copies of all agreements relating to shared facilities, co-working spaces, incubator space, or shared laboratory facilities, together with any rules and regulations governing the use of shared spaces and any allocation of costs or common area expenses.
9.5. A description of any pending or threatened condemnation, eminent domain, or taking proceedings affecting any property occupied or used by Caliston. If none, please confirm.
9.6. Copies of any notices of default, notices of breach, notices of termination, or cure notices received or sent under any real property lease, together with any correspondence relating to the resolution of any such defaults or breaches.
9.7. Copies of all estoppel certificates, subordination, non-disturbance, and attornment agreements ("SNDAs"), landlord consents, and landlord waivers obtained or requested by Caliston in connection with any real property lease.
CATEGORY 10: ENVIRONMENTAL MATTERS
10.1. Copies of all environmental permits, licenses, registrations, and authorizations held by Caliston, including any permits required for the use, storage, handling, or disposal of hazardous materials, biological agents, radioactive materials, or controlled substances at any Company facility.
10.2. Copies of all environmental audits, Phase I environmental site assessments, Phase II environmental site assessments, remediation reports, closure reports, and other environmental investigations or studies performed at or relating to any property currently or formerly occupied or used by Caliston.
10.3. All correspondence between Caliston and any federal, state, or local environmental agency, including the United States Environmental Protection Agency ("EPA"), the Massachusetts Department of Environmental Protection, and any other environmental regulatory body, including any notices, requests for information, or compliance orders.
10.4. A description of any pending or threatened environmental claims, enforcement actions, notices of violation, administrative orders, consent orders, or clean-up obligations involving Caliston or any property currently or formerly occupied or used by Caliston. If none, please confirm.
10.5. A description of all hazardous materials, hazardous substances, biological materials (including biohazardous agents and genetically modified organisms), radioactive materials, and other regulated substances used, generated, stored, transported, or disposed of in connection with Caliston's laboratory, manufacturing, and research operations, including the types and quantities of materials and the applicable regulatory requirements governing their handling and disposal.
10.6. Copies of all waste disposal contracts, hazardous waste transporter agreements, hazardous waste treatment, storage, and disposal facility agreements, hazardous waste manifests, and land disposal restriction certifications for the past three years, together with copies of any EPA Identification Numbers or state equivalents assigned to Caliston.
CATEGORY 11: INSURANCE
11.1. A schedule of all insurance policies currently in force maintained by or on behalf of Caliston, including the following types of coverage (to the extent applicable): (a) commercial general liability, (b) product liability, (c) clinical trial liability (including clinical trial insurance and study subject injury coverage), (d) property and casualty, (e) workers' compensation, (f) directors' and officers' liability, (g) key person insurance, (h) employment practices liability, (i) errors and omissions (professional liability), (j) cyber liability and data breach coverage, (k) umbrella/excess liability, and (l) any other insurance coverage. For each policy, please identify the insurer, the policy number, the policy period, the coverage limits, the deductibles or self-insured retentions, the annual premium, and the named insured(s) and any additional insureds.
11.2. Complete copies of all insurance policies identified in response to Request 11.1, including all declarations pages, coverage forms, endorsements, riders, and any binders or certificates of insurance.
11.3. A schedule of all claims made, notices of claim submitted, or claims pending under any insurance policy maintained by or on behalf of Caliston during the past five years, including for each claim: (a) the date of the claim, (b) the nature of the claim, (c) the policy under which the claim was submitted, (d) the amount of the claim, (e) the amount paid or reserved, and (f) the current status of the claim.
11.4. Copies of all correspondence between Caliston and any insurer or insurance broker regarding denial of coverage, reservation of rights, disputed claims, policy cancellation, non-renewal, or any other coverage dispute.
11.5. Copies of any "tail" policies, "run-off" policies, or extended reporting period endorsements purchased or maintained by Caliston in connection with prior claims, prior corporate events, or the departure of any director or officer.
CATEGORY 12: DATA PRIVACY AND CYBERSECURITY
12.1. Copies of all privacy policies, privacy notices, and data collection disclosures published by Caliston, including website privacy policies, mobile application privacy policies, internal employee privacy notices, and any privacy notices provided to clinical trial participants. Please provide both current versions and all prior versions in effect during the past three years.
12.2. A comprehensive description of all categories of personal data and protected health information collected, processed, stored, transmitted, or otherwise handled by Caliston, including clinical trial participant data (including individually identifiable health information and coded data), employee and applicant data, vendor and contractor data, investor data, and website visitor data. For each category, please describe the sources of the data, the purposes for which it is used, the systems in which it is stored, and the recipients to whom it is disclosed.
12.3. Copies of all data processing agreements, data protection agreements, data use agreements, and business associate agreements (to the extent HIPAA is applicable) entered into between Caliston and any third party, including CROs, CDMOs, clinical trial sites, cloud service providers, IT vendors, and data analytics providers.
12.4. A description of Caliston's cybersecurity policies, procedures, standards, and practices, including: (a) information security policies, (b) data classification and handling policies, (c) access control procedures, (d) encryption standards, (e) network security measures, (f) vulnerability management and penetration testing practices, (g) incident response plans, and (h) business continuity and disaster recovery plans. Please provide copies of all written policies and plans.
12.5. A description of any data breaches, security incidents, unauthorized access events, or other cybersecurity incidents experienced by Caliston during the past five years, including for each incident: (a) the date of the incident, (b) the nature and scope of the incident, (c) the categories and number of individuals affected, (d) the response and remediation actions taken, (e) any notifications provided to affected individuals, regulators, or law enforcement, and (f) any resulting litigation, regulatory investigation, or fines. If none, please confirm.
12.6. All correspondence between Caliston and any data protection authority, privacy regulator, attorney general, or other governmental body regarding data privacy or cybersecurity matters, including any inquiries, complaints, enforcement actions, or consent orders.
12.7. A description of Caliston's compliance with applicable data privacy and data security laws and regulations, including without limitation: (a) the Health Insurance Portability and Accountability Act of 1996 ("HIPAA") and the HITECH Act (to the extent applicable), (b) the European Union General Data Protection Regulation ("GDPR") (to the extent applicable), (c) the California Consumer Privacy Act ("CCPA") and the California Privacy Rights Act ("CPRA") (to the extent applicable), (d) state data breach notification laws, and (e) any other data privacy or data security laws applicable to Caliston's operations. Please describe any gap analyses, compliance assessments, or readiness reviews that have been conducted.
12.8. Copies of all agreements with third-party data processors, cloud computing service providers, hosting providers, software-as-a-service ("SaaS") providers, and IT vendors that involve the processing, storage, or transmission of personal data, protected health information, or other sensitive or regulated data, to the extent not previously produced in response to Request 12.3.
CATEGORY 13: COMPLIANCE AND GOVERNMENTAL MATTERS
13.1. A description of Caliston's corporate compliance program, including all written policies and procedures relating to: (a) anti-corruption and anti-bribery compliance (including compliance with the Foreign Corrupt Practices Act ("FCPA") and any applicable state or foreign anti-corruption laws), (b) compliance with the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b), (c) compliance with the federal False Claims Act (31 U.S.C. §§ 3729–3733), (d) fraud and abuse compliance, (e) the Physician Payments Sunshine Act (Open Payments) reporting, and (f) any other applicable healthcare compliance laws and regulations. Please provide copies of all compliance policies, codes of conduct, compliance training materials, and descriptions of compliance program infrastructure (e.g., compliance officer, compliance committee, anonymous reporting mechanisms).
13.2. A description of all compliance audits, internal investigations, compliance assessments, or hotline reports conducted or received during the past three years, including for each: (a) the date and nature of the matter, (b) the findings or conclusions, (c) any corrective actions taken, and (d) the current status. Please provide copies of all written reports, findings, and corrective action plans.
13.3. Copies of all government licenses, permits, approvals, certifications, and registrations held by Caliston that are not otherwise addressed in Categories 5 (Regulatory and FDA Matters) or 10 (Environmental Matters), including any state business licenses, professional licenses, and local operating permits.
13.4. All correspondence with, submissions to, or filings with the Securities and Exchange Commission ("SEC"), the Federal Trade Commission ("FTC"), the Department of Justice ("DOJ"), the Department of Health and Human Services ("HHS") (other than FDA matters addressed in Category 5), or any other federal, state, or local governmental agency not otherwise addressed in other categories of this request list.
13.5. Copies of all lobbying disclosures, lobbying re