Document:

EX-10.1

 Exhibit 10.1 

IN THE COURT OF CHANCERY OF THE STATE OF DELAWARE 
  

			
	 HEDGEPATH, LLC,
  

Plaintiff,
  

v.
	  	C.A. No. 2019-0529-JTL
		
	 BRENDAN MAGRAB, STEFAN J. CROSS, DR. R. DANA ONO, ROBERT D. MARTIN, W. MARK WATSON, NICHOLAS J. VIRCA and MAYNE PHARMA VENTURES PTY LTD.,

 
 Defendants,

 
 and
	  	
		
	 HEDGEPATH PHARMACEUTICALS, INC., a Delaware corporation,
  

Nominal Defendant.
	  	
		
	 SAMUEL SEARS, Individually And On Behalf of All Others Similarly Situated,

Plaintiff,
  

v.
  

BRENDAN MAGRAB, STEFAN J. CROSS, DR. R. DANA ONO, ROBERT D. MARTIN, W. MARK WATSON, NICHOLAS J. VIRCA, and MAYNE PHARMA VENTURES PTY LTD.,

 
 Defendants.
	  	C.A. No. 2020-0215-JTL

  

 STIPULATION AND AGREEMENT OF 

COMPROMISE, SETTLEMENT, AND RELEASE  

This Stipulation and Agreement of Compromise, Settlement, and Release (the “Stipulation,” the terms of which are the
“Settlement”), dated as of September 9, 2022, is entered into between (i) Plaintiffs Hedgepath, LLC and Samuel Sears (“Plaintiffs”); (ii) defendants Brendan Magrab, Stefan J. Cross, R. Dana Ono,
Robert D. Martin, W. Mark Watson, Nicholas J. Virca (“Individual Defendants”), and Mayne Pharma Ventures Pty Ltd. (“Mayne”); and (iii) Inhibitor Therapeutics, Inc., f/k/a Hedgepath Pharmaceuticals, Inc.
(“Nominal Defendant” or the “Company”) (collectively with the Individual Defendants and Mayne, “Defendants”). Each Plaintiff and Defendant is referred to individually as a “Party,”
and they are referred to collectively as the “Parties.” The Parties intend for this Stipulation to fully, finally, and forever resolve, discharge, and settle the above-captioned actions (together, the “Actions”) and
the Released Claims (as defined below), subject to the approval of the terms and conditions of the Stipulation by the Court of Chancery of the State of Delaware (the “Court”); 

PROCEDURAL BACKGROUND 

WHEREAS: 
 A. The Company is a
pharmaceutical development company that is focused on developing and ultimately commercializing innovative therapeutics for patients with certain cancers and certain non-cancerous proliferation disorders. On
August 20, 2019, the Company changed its name from HedgePath Pharmaceuticals (OTCQG:HPPI) to Inhibitor Therapeutics, Inc. (OTCQB:INTI). As of the date of this Stipulation, the Company has approximately 376,858,323 shares of Company common stock
issued and outstanding. 

  
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 B. The Company’s majority stockholder, Mayne, is an Australian specialty pharmaceutical
company that develops and manufactures branded and generic products, which it distributes directly or through distribution partners and provides contract development and manufacturing services. Mayne licensed to and supplied the Company with
SUBA-Itraconazole, Mayne Pharma’s patented formulation of itraconazole. Until December 17, 2018, the Company had sought FDA approval to use SUBA-Itraconazole as a treatment for basal cell carcinoma in patients with Basal Cell Carcinoma
Nevus Syndrome (“BCCNS”) within the United States. 
 C. On July 9, 2019, Plaintiff Hedgepath, LLC filed a complaint
(the “Initial Hedgepath Complaint”; Transaction ID 63524207) initiating the litigation styled Hedgepath, LLC v. Magrab et al., C.A. No. 2019-0529-JTL (the “Hedgepath
Action”). Hedgepath, LLC is the Company’s second largest stockholder (after Mayne) and, as of the date of this Stipulation, owns 79,627,069 shares of Company common stock. 

  
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 D. The Initial Hedgepath Complaint alleged direct and derivative claims for breach of
fiduciary duty, waste, declaratory judgment, statutory violations under 8 Del C. § 271, and dilution of stockholder equity, against the Individual Defendants and Mayne relating to, inter alia, (i) the issuance of certain of
the Company’s equity securities to Mayne on or about January 8, 2018 (the “January 2018 Transactions”), and (ii) the Third Amended and Restated Supply and License Agreement between the Company and Mayne
(“Third Amended SLA”) and certain transactions contemplated thereby (the “December 2018 Transactions,” and together with the January 2018 Transactions, the “Challenged Transactions”)). The Initial
Hedgepath Complaint also alleged claims for breach of fiduciary duty and fraudulent misrepresentation in connection with allegedly false and misleading statements included in the Company’s press releases and filings with the SEC. The Initial
Hedgepath Complaint sought damages from Defendants, as well as equitable and other relief. 
 E. Before filing the Initial Hedgepath
Complaint, Hedgepath, LLC served the Company with a corporate books and records demand pursuant to 8 Del. C. § 220 (“Section 220”) to investigate, among other things, alleged breaches of fiduciary duty
in connection with, inter alia, the Challenged Transactions (the “HPLLC 220 Demand”). The Company produced to Hedgepath, LLC more than 13,000 pages of nonpublic Board-level, and senior officer-level corporate books and
records regarding the Challenged Transactions (“Section 220 Documents”). 

  
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 F. On September 27, 2019, Defendants moved to dismiss the Initial Hedgepath Complaint
(Transaction ID 64604558). Among other things, the motions argued that the Initial Hedgepath Complaint failed to state a claim under Court of Chancery Rules 9(b) and 12(b)(6) and, with respect to the derivative claims, failed to adequately plead
demand futility under Rule 23.1. 
 G. On October 17, 2019, Plaintiff Samuel Sears (“Plaintiff Sears”) served the
Company with a Section 220 demand to investigate, among other things, alleged breaches of fiduciary duty in connection with, inter alia, the Challenged Transactions (“Sears 220 Demand” and with the HPLLC 220 Demand, the
“Section 220 Demands”). The Company produced to Plaintiff Sears the same Section 220 Documents the Company produced to Plaintiff Hedgepath, LLC. 

H. On December 3, 2019, Plaintiff Hedgepath, LLC filed an amended complaint (the “Amended Hedgepath Complaint”;
Transaction ID 64481043). 
 I. On January 10, 2020, Defendants moved to dismiss the Amended Hedgepath Complaint for the same reasons
set forth in their original motions to dismiss. 
 J. On March 23, 2020, Plaintiff Samuel Sears filed a class action complaint (the
“Sears Complaint”; Transaction ID 65532758) initiating the litigation styled Samuel Sears v. Magrab et al., C.A. No. 2020-0215-JTL (the “Sears Action”). The Sears
Complaint asserted breach of fiduciary duty claims similar to those asserted in the Hedgepath Action. While the Amended Hedgepath Complaint 

  
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asserted its breach of fiduciary duty claims derivatively, the Sears Complaint purported to assert all of its claims on behalf a “Class” defined to include “all other holders of
the Company’s common stock (except Defendants herein and any persons, firm, trust, corporation, or other entity related to or affiliated with them and their
successors-in-interest) who are or will be threatened with injury arising from Defendants’ wrongful action.” 

K. On April 23, 2020, Defendants moved to dismiss the Sears Complaint. 

L. On May 18, 2020, Plaintiff Sears filed his amended complaint (the “Amended Sears Complaint”; Transaction ID
65532758). 
 M. On June 4, 2020, following briefing and oral argument, the Court denied Defendants’ motions to dismiss the
Amended Hedgepath Complaint. 
 N. On June 17, 2020, in light of the Court’s ruling in the Hedgepath Action, Defendants withdrew
their motions to dismiss the Sears Complaint (Transaction ID 65705316). 
 O. On June 17, 2020, HedgePath, LLC served its First Set of
Requests for Production of Documents Directed to all Defendants and its First Set of Interrogatories Directed to all Defendants. 
 P.
Between August and September 2020, Defendants served Responses and Objections to Hedgepath, LLC’s discovery requests. 

  
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 Q. Between August and October 2020, Hedgepath, LLC served subpoenas on third parties The
Weinberg Group, LLC, SciQuus, Inc., Ellenoff Grossman & Schole LLP, and Mentara, Inc. 
 R. On September 2, 2020, Plaintiff
Sears served his First Request for Production of Documents Directed to All Defendants. 
 S. On September 17, 2020, the Individual
Defendants served their First Set of Interrogatories Directed to Plaintiffs and their First Set of Requests for the Production of Documents Directed to Plaintiffs. 

T. On September 17, 2020, Mayne served its First Set of Interrogatories Directed to Plaintiffs Hedgepath, LLC and Samuel Sears and their
First Set of Requests for Production of Documents from Plaintiffs Hedgepath, LLC and Samuel Sears. 
 U. On November 2, 2020, Plaintiff
Sears served his responses to the Individual Defendants’ First Set of Interrogatories Directed to Plaintiffs, the Individual Defendants’ First Set of Requests for the Production of Documents Directed to Plaintiffs, Mayne’s First Set
of Interrogatories Directed to Plaintiffs Hedgepath, LLC and Samuel Sears, and Mayne’s First Set of Requests for Production of Documents from Plaintiffs Hedgepath, LLC and Samuel Sears. 

V. On December 9, 2020, the Parties to the Hedgepath Action and the Sears Action filed a Stipulation and Proposed Order Regarding
Coordination of Related Actions (Transaction ID 66172844), which required the parties to the 

  
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Actions to coordinate in good faith on all matters where it is practicable to do so, conduct the litigation in a manner designed to avoid duplication, and promote the efficient and speedy
resolution of the Actions. On December 10, 2020, the Court granted the Stipulation and Order Regarding Coordination of Related Actions (Transaction ID 66176455). 

W. In January 2021, the Parties agreed to discuss a potential resolution of the Actions. Between December 2020 and October 2021, at the
request of Plaintiffs and to allow Plaintiffs to evaluate a potential settlement, Defendants produced more than 44,000 pages of documents to Plaintiffs. 

X. On November 4, 2021, the Parties participated in a confidential mediation before the Honorable Stephen P. Lamb. Following the
mediation, the Parties continued to engage in arm’s-length negotiations, including the exchange of numerous offers and counteroffers. 

Y. On June 20, 2022, the Parties reached an
agreement-in-principle to settle the claims asserted in the Actions for the Settlement Consideration reflected in Paragraphs 2–13 below, subject to the execution of
the Stipulation and related papers and Court approval. 
 Z. On June 27, 2022, via a joint status letter, the Parties informed the
Court that the Parties had reached an agreement-in-principle to fully resolve the Actions (Transaction ID 67765786). 

  
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 AA. Following an analysis of the strengths and weaknesses of the claims asserted in the
Actions, including review and analysis of the documents Plaintiffs received, Plaintiffs believe that the Settlement Consideration described in Paragraphs 2–13 below provides the Company and the Class with substantial benefits. 

BB. Although Plaintiffs believe that the Actions assert strong claims, they are agreeing to settle the Actions to eliminate the uncertainties
inherent in further litigation and in recognition of the benefits this Settlement will afford the Company and the Class. 
 CC. Plaintiffs
have determined that the terms of the Settlement are fair, reasonable, adequate, and in the best interests of the Company and the Class, and that it is reasonable to pursue a settlement of the Actions based upon those terms and the procedures
outlined herein. 
 DD. At all times, Defendants have denied, and continue to deny, all allegations of wrongdoing in the Complaints,
including without limitation that they have committed any breach of fiduciary duty, that they have violated Delaware law, that they have made any misrepresentations, or that Plaintiffs have suffered damages. 

EE. Defendants expressly maintain that they have at all times complied with their fiduciary and other legal duties. 

  
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 FF. Although Defendants believe that they have strong defenses to the claims asserted in the
Actions, Defendants are entering into this Stipulation because the Settlement will eliminate the burden, expense, distraction, and uncertainties inherent in further litigation. 

GG. This Stipulation (together with the Exhibits hereto), which has been duly executed by the undersigned signatories on behalf of their
respective clients, reflects the final and binding agreement among the Parties concerning the Settlement, subject to Court approval. 

NOW, THEREFORE, IT IS STIPULATED AND AGREED, in consideration of the benefits set forth below, and subject to the approval of the Court
pursuant to Court of Chancery Rules 23 and 23.1, that the Actions and the Released Claims (as defined below) shall be compromised, settled, released, and dismissed with prejudice on the merits and without costs (except as provided below), subject to
the following terms and conditions: 
 DEFINITIONS 

1. The following terms shall have the meanings assigned to them herein: 

  
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 (a) “Class” shall mean the class of all record holders and beneficial owners of
Company common stock who held such stock at any time during the period between and including January 8, 2018 and December 17, 2018 (except as limited by the following sentence), and their heirs, assigns, transferees, and successors-in-interest, in each case solely in their capacity as holders or owners of Company common stock. Excluded from the Class are (i) the Individual Defendants
and Mayne (collectively, the “Excluded Parties” and each an “Excluded Party”); (ii) any Individual Defendant’s Immediate Family Members (as defined below); (iii) any persons, firm, trust, corporation, or other entity
affiliated with an Excluded Party and their successors-in-interest; and (iv) any entity in which any Excluded Party has or had a direct or indirect controlling interest. 

(b) “Class Member” shall mean a member of the Class. 

(c) “Immediate Family Member” means any children, stepchildren, parents, stepparents, spouses and siblings. As used in this
Paragraph, “spouse” shall mean a husband, a wife, or a partner in a state-recognized domestic relationship or civil union. 
 (d)
“Complaints” shall mean the Amended Hedgepath Complaint and the Amended Sears Complaint. 
 (e) “Plaintiffs’
Releasees” shall mean each of the Company, Plaintiffs, and each Class Member, and each of their respective parents, subsidiaries, affiliates, and controlling persons, and any current or former officer, director, member or manager of any of
the foregoing, and each of their respective heirs, trusts, trustees, executors, estates, administrators, beneficiaries, distributees, foundations, 

  
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agents, employees, fiduciaries, partners, partnerships, general or limited partners or partnerships, joint ventures, member firms, limited liability companies, corporations, divisions, parents,
subsidiaries, affiliates, associated entities, stockholders, principals, officers, directors, managing directors, members, managers, managing members, managing agents, predecessors,
predecessors-in-interest, successors, successors-in-interest, assigns financial or
investment advisors, attorneys (including all Plaintiffs’ counsel in these Actions), personal or legal representatives, accountants, insurers, co-insurers, reinsurers, and associates.  

(f) “Defendants’ Releasees” shall mean each of Brendan Magrab, Stefan J. Cross, R. Dana Ono, Robert D. Martin, W. Mark Watson,
Nicholas J. Virca, and Mayne, and each of their respective parents, subsidiaries, affiliates, and controlling persons, and any current or former officer, director, member or manager of any of the foregoing, and each of their respective heirs,
trusts, trustees, executors, estates, administrators, beneficiaries, distributees, foundations, agents, employees, fiduciaries, partners, partnerships, general or limited partners or partnerships, joint ventures, member firms, limited liability
companies, corporations, divisions, parents, subsidiaries, affiliates, associated entities, stockholders, principals, officers, directors, managing directors, members, managers, managing members, managing agents, predecessors, predecessors-in-interest, successors, successors-in-interest, assigns, financial or investment
advisors, attorneys (including all Defendants’ counsel in these Actions), personal or legal representatives, accountants, insurers, co-insurers, reinsurers, and associates. 

  
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 (g) “Plaintiffs’ Releasors” shall mean each of the Company, the Plaintiffs,
the Class, each Class Member and each of their respective parents, subsidiaries, affiliates and controlling persons, successors-in-interest, and assigns. 

(h) “Defendants’ Releasors” shall mean each of Brendan Magrab, Stefan J. Cross, R. Dana Ono, Robert D. Martin, W. Mark Watson,
Nicholas J. Virca, and Mayne, and each of their respective parents, subsidiaries, affiliates and controlling persons, successors-in-interest, and assigns. 

(i) “Releasing Parties” shall mean Plaintiffs’ Releasors and Defendants’ Releasors, collectively. 

(j) “Plaintiffs’ Released Claims” shall mean any and all manner of claims, demands, rights, liabilities, losses, obligations,
duties, damages, costs, debts, expenses, interest, penalties, sanctions, fees, attorneys’ fees, actions, potential actions, causes of action, suits, agreements, judgments, decrees, matters, issues, and controversies of any kind, nature, or
description whatsoever, whether known or unknown, disclosed or undisclosed, accrued or unaccrued, apparent or not apparent, foreseen or unforeseen, matured or not matured, suspected or unsuspected, liquidated or not liquidated, fixed or contingent,
including, without limitation, Unknown Claims (as defined herein), whether based on state, local, foreign, federal, 

  
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statutory, regulatory, common or other law or rule, that are, have been, could have been, or could now be asserted in the Actions or in any other court, tribunal, forum, suit, action or
proceeding, by any of the Plaintiffs’ Releasors or any member of the Class, derivatively on behalf of the Company, or individually or as a member of the Class directly (in their capacities as current or former Company stockholders), or by
the Company directly against any of the Defendants’ Releasees that are based upon, relate in any way to, arise out of or involve, directly or indirectly, in whole or in part, the actual, alleged, or attempted actions, inactions, transactions,
claims, facts, events, conduct, occurrences, practices, statements, representations, misrepresentations, omissions, allegations, votes, contracts, decisions, or any other matters, things, or causes whatsoever, or any series thereof, in connection
with the Actions or the subject matter of the Actions or alleged, asserted, set forth, claimed, or referred to in the Complaints or any former complaints in the Actions, including, without limitation (i) the Challenged Transactions,
(ii) any and all agreements between Mayne or its affiliates on the one hand, and the Company or Hedgepath LLC or its principals on the other hand, (iii) any statements by the Company or Defendants related to or in connection with the
Challenged Transactions, or the agreements referenced in part (ii) of this sentence, or alleged in the Complaints; provided, however, that Plaintiffs’ Released Claims shall not include claims relating to the enforcement of the Settlement
(including any agreements or provisions of agreements identified in this Stipulation as surviving the Settlement). 

  
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 (k) “Defendants’ Released Claims” shall mean any and all manner of claims,
demands, rights, liabilities, losses, obligations, duties, damages, costs, debts, expenses, interest, penalties, sanctions, fees, attorneys’ fees, actions, potential actions, causes of action, suits, agreements, judgments, decrees, matters,
issues, and controversies of any kind, nature, or description whatsoever, whether known or unknown, disclosed or undisclosed, accrued or unaccrued, apparent or not apparent, foreseen or unforeseen, matured or not matured, suspected or unsuspected,
liquidated or not liquidated, fixed or contingent, including, without limitation, Unknown Claims (as defined herein), whether based on state, local, foreign, federal, statutory, regulatory, common, or other law or rule, that are, have been, could
have been, or could now be asserted in the Actions or in any other court, tribunal, forum, suit, action or proceeding by any of the Defendants’ Releasors against any of the Plaintiffs’ Releasees that are based upon, relate in any way to,
arise out of or involve, directly or indirectly, in whole or in part, the Section 220 Demands, the prosecution of the Actions or the subject matter thereof, including, without limitation, any and all agreements between Mayne or its affiliates
on the one hand, and the Company or Hedgepath LLC or its principals on the other hand; provided, however, that Defendants’ Released Claims shall not include claims relating to the enforcement of the Settlement (including any agreements or
provisions of agreements identified in this Stipulation as surviving the Settlement). 

  
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 (l) The “Released Claims” shall mean Plaintiffs’ Released Claims and
Defendants’ Released Claims, collectively. For avoidance of doubt, the Released Claims do not include any rights or claims that the Company and Defendants may have against their insurers. 

(m) “Effective Date” shall have the meaning provided in Paragraph 36 below. 

(n) “Mayne Debt” shall mean the $3,000,000 (United States Dollars) advance made by Mayne to the Company pursuant to the Third Amended
SLA. 
 (o) “Mayne Equity Holdings” shall mean all equity securities in the Company, including Company common stock, Company
preferred stock, warrants to purchase Company stock, and options to purchase Company stock, that is held or owned, beneficially or of record, by Mayne (or any parent or subsidiary thereof), consisting of 205,065,189 shares of Company common stock,
17,391,306 shares of Company common stock upon conversion of Series B Preferred Stock, and warrants to purchase 4,347,827 shares of Company common stock as of the date of this Stipulation. 

  
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 (p) “Mayne Short-Term Financing” shall mean (i) the $371,000 (United States
Dollars) currently owed by the Company to Mayne in connection with a term debt facility memorialized in letter agreements dated December 12, 2020, January 13, 2022, and March 9, 2022 (Exhibits 10.11, 10.12, and 10.13, respectively, to
the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission on March 30, 2022), and a letter agreement dated July 1, 2022, and (ii) any interim
financing, in an amount not to exceed $86,000 (United States Dollars), that Mayne may provide to the Company between the date of the Stipulation and the Effective Date to fund the Company’s operating expenses (subject to Paragraphs 20 and 22
below) and expenses relating to Notice (as defined below). For the avoidance of doubt, under no circumstances shall the Mayne Short-Term Financing exceed $457,000 (United States Dollars) in the aggregate, and following the Effective Date, the
Company shall have no obligation to pay or repay any amounts to Mayne other than the Mayne Short-Term Financing. 
 (q)
“SUBA-Itraconazole BCCNS” shall mean the use of SUBA-Itraconazole targeting basal cell carcinoma in patients with Basal Cell Carcinoma Nevus Syndrome. 

(r) “Non-SUBA Formulations of Itraconazole” shall mean any formulations of Itraconazole that
do not infringe on the claims of the itraconazole formulation described in U.S. Patent 8,771,739 “Pharmaceutical Compositions for Poorly Soluble Drugs.” 

  
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 (s) “Company Stockholders” shall refer to each and every person who is a record
holder or beneficial owner of Company common stock as of the date that the Stipulation is filed with the Court. 
 (t) “Unknown
Claims” are claims that the Releasing Parties did not know or suspect to exist at the time of the release. 
 SETTLEMENT
CONSIDERATION 
 2. Within five (5) business days of the Effective Date, the Individual Defendants and Mayne shall pay or cause
to be paid to the Company a total of $14,250,000 (United States Dollars) in cash paid via wire transfer or check (the “Cash Consideration”). 

3. The Mayne Equity Holdings shall be surrendered to the Company and canceled. Such surrender and cancellation will occur upon the Effective
Date. The Individual Defendants shall retain any Company common stock that they own as of the Effective Date, but any options, warrants, or other rights to purchase Company shares that they possess shall be cancelled. 

4. The Mayne Debt shall be canceled. Such cancellation will occur upon the Effective Date. Within ten (10) business days of receiving the
Cash Consideration, the Company shall repay to Mayne the Mayne Short-Term Financing.
 5. After the Effective Date, except as expressly
provided herein, the Company shall have no further obligations to (and shall owe no amounts to) Mayne or the Individual Defendants except with respect to Company common stock held by the Individual Defendants. 

  
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 6. Upon the Effective Date, the Company shall convert the license, from the Company to
Mayne, for the following intellectual property owned by the Company from exclusive to non-exclusive, without restriction as to field: 
  

	 	a.	 U.S. Patent 9,129,609 

Treatment and Prognostic Monitoring of Proliferation 

Disorders Using Hedgehog Pathway Inhibitors 

Issued: 11-24-2015; Expires: 02-05-2034 
  

	 	b.	 U.S. Patent 9,962,381 

Treatment and Prognostic Monitoring of Cancerous Proliferation 

Disorders Using Hedgehog Pathway Inhibitors 

Issued: 05-08-2018; Expires: 02-05-2034 
  

	 	c.	 U.S. Patent 9,968,600 

Treatment and Prognostic Monitoring of Non-Cancerous Proliferation 

Disorders Using Hedgehog Pathway Inhibitors 

Issued: 05-05-2018; Expires: 02-05-2034 
  

	 	d.	 U.S. Patent 10,328,072 

Treatment of Lung Cancer Using Hedgehog Pathway Inhibitors 

Issued: 6-25-2019; Expires: 02-05-2034 
  

	 	e.	 U.S. Patent 10,363,252 

Treatment of Prostate Cancer Using Hedgehog Pathway Inhibitors 

Issued: 07-30-2019; Expires: 02-05-2034 
 The non-exclusive license of
the aforementioned patents to Mayne under this Paragraph 6 shall be memorialized in a separate license agreement, entered into between INTI and Mayne, which shall survive this Stipulation. 

  
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 7. Upon the Effective Date, Mayne will terminate the following licenses, from Mayne to the
Company, for the following intellectual property owned or licensed by Mayne: 
  

	 	a.	 The sublicense agreement, dated August 27, 2019, from Mayne Pharma International Pty Ltd, an affiliate of
Mayne, for the exclusive U.S. patent rights to U.S. patent No 8,653,083 entitled “Hedgehog Pathway Antagonists to Treat Disease”, issued on February 28, 2014 and U.S. patent No 8,980.930 entitled “Angiogenesis Inhibitors”,
issued March 17, 2015 (the “JHU Patents”) 

  

	 	b.	 U.S. Patent 8,771,739 

Pharmaceutical Compositions for Poorly Soluble Drugs 

Issued: 07-08-2014; Expires: 12-16-2022 
  

	 	c.	 U.S. Patent 8,921,374 

Itraconazole Compositions and Dosage Forms and Methods Using Same 

Issued: 12-30-2014; Expires: 06-21-2033 
  

	 	d.	 U.S. Patent 9,272,046 

Itraconazole Compositions and Dosage Forms and Methods Using Same 

Issued: 03-01-2016; Expires: 06-21-2033 
  

	 	e.	 U.S. Patent 9,713,642 

Itraconazole Compositions and Dosage Forms and Methods Using Same 

Issued: 07-25-2017; Expires: 06-21-2033 
  

	 	f.	 U.S. Patent 10,473,740 

Itraconazole Compositions and Dosage Forms and Methods Using Same 

Issued: 11-05-2019; Expires: 06-21-2033 

  
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	 	g.	 U.S. Patent 10,806,792 

Itraconazole Compositions and Dosage Forms and Methods Using Same 

Issued: 10-20-2019; Expires: 06-21-2033 
 Mayne further agrees that the Company will not owe or be required to
pay any amounts that may be due under the licenses referenced in this Paragraph 7. 
 8. After the Effective Date, Mayne will remain amenable
to discussing with the Company, in good faith, the potential licensing and/or sub-licensing of the JHU Patents, for a commercially reasonable licensing fee, to the extent the Company seeks to engage in such
discussions. 
 9. Mayne will not take the position that the Company or persons affiliated with the Company, including
Dr. Francis E. O’Donnell, Jr., are prohibited from developing or commercializing Non-SUBA Formulations of Itraconazole for any cancer or non-cancer
indications. Nor shall Mayne take any action intended to restrict or limit the Company’s ability or efforts to develop or commercialize Non-SUBA Formulations of Itraconazole for any cancer or non-cancer indications. 
 10. Upon the Effective Date, the Third Amended SLA shall be deemed void and each
party shall be released from its rights and obligations thereunder; provided, however, that the Company will retain the right to a 9% cash royalty on future net sales, if any, of SUBA-Itraconazole BCCNS in the United States, on the same terms set
forth in the Third Amended SLA (the “Royalty”). For the avoidance of doubt, although the Mayne Debt shall in other respects be canceled under Paragraph 4 of this Stipulation, any Royalty will first be applied to pay down the $3,000,000
(United States Dollars) advanced by Mayne to the Company under the Third Amended SLA, after which any further Royalties will be paid to the Company. 

  
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 11. Mayne, in its sole and exclusive discretion, shall determine whether to develop
SUBA-Itraconazole BCCNS. 
 12. Upon the Effective Date, the Equity Holders Agreement by and between the Company, Mayne, Hedgepath, LLC,
Dr. Francis O’Donnell, and Nicholas Virca, dated as of June 24, 2014, as amended May 15, 2015 (the “EHA”), shall be deemed terminated pursuant to Section 8.1(b) of the EHA. 

13. Any of the Individual Defendants who holds a position with the Company shall retire from each such position effective upon the Effective
Date. At least five days before the Settlement Hearing, the Company’s board shall execute a unanimous written consent appointing Dr. Francis E. O’Donnell, Jr. as a director of the Company effective upon the Effective Date. 

PARTY REPRESENTATIONS 

14. The Parties agree that the representations and warranties set forth herein are a material part of the Settlement and they are relying on
the representations and warranties in connection with agreeing to the Settlement. 

  
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 15. Each of the Plaintiffs represents and warrants that he or it has been a stockholder of
the Company since prior to January 1, 2018, continually to the present, that as of the date hereof he or it continues to hold stock in the Company, and that he or it shall continue to hold such stock in the Company through the Effective Date.
Each Plaintiff further represents that he or it has not sold, traded, collateralized, divested, alienated, assigned, or otherwise transferred the claims asserted in the Actions, or any of the Plaintiffs’ Released Claims, to any person. 

16. Mayne represents and warrants that it currently owns or has the rights to 205,065,189 shares of Company common stock, 17,391,306 shares of
Company common stock upon conversion of Series B Preferred Stock, and warrants to purchase 4,347,827 shares of Company common stock, and that it has not exercised, sold, traded, canceled, collateralized, divested, alienated, assigned, or otherwise
impaired its rights to any of the Mayne Equity Holdings subject to surrender and cancellation under Paragraph 3 of this Stipulation, and that it shall not exercise, sell, trade, cancel, collateralize, divest, alienate, assign, or otherwise impair
its rights to any of the Mayne Equity Holdings subject to surrender and cancellation under Paragraph 3 of this Stipulation. 

  
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 17. Each of the Individual Defendants represents and warrants that he currently owns the
amount of Company equity securities (or options or rights to acquire Company equity securities) set forth next to his name: Brendan Magrab (65,000 shares of common stock; no vested stock options); Stefan J. Cross (no equity securities); R. Dana Ono
(453,000 shares of common stock; 3,080,734 vested stock options); Robert D. Martin (60,000 shares of common stock; 2,930,734 vested stock options); W. Mark Watson (1,054,100 shares of common stock; 4,227,347 vested stock options); Nicholas J. Virca
(8,727,519 shares of common stock; 535,000 vested stock options). 
 18. The Individual Defendants further represent and warrant that they
shall not exercise, sell, trade, cancel, collateralize, divest, alienate, assign, or otherwise impair any options or other rights to acquire Company stock subject to surrender and cancellation under Paragraph 3 of this Stipulation. 

19. Mayne represents and warrants that apart from the surrender and cancellation under Paragraph 4 of this Stipulation, it has not exercised,
sold, traded, canceled, collateralized, divested, alienated, assigned, or otherwise impaired its rights to any of the Mayne Debt, and that it shall not exercise, sell, trade, cancel, collateralize, divest, alienate, assign, or otherwise impair its
rights to any of the Mayne Debt. 
 20. The Company represents and warrants that, prior to the Effective Date, the Company shall not:
(i) issue any additional Company equity securities (or options or rights to acquire Company equity securities); (ii) incur or assume any additional debt on behalf of the Company that is not paid prior to the Effective Date

  
 24 

 
(except in the ordinary course of the Company’s business, or as is reasonably necessary in connection with the Company’s obligations and contemplated actions set forth in this
Stipulation); or (iii) repay any of the Mayne Debt. Mayne represents and warrants that, prior to the Effective Date, it shall not take any actions to cause the Company to: (i) issue any additional Company equity securities (or options or
rights to acquire Company equity securities); (ii) incur or assume any additional debt on behalf of the Company that is not paid prior to the Effective Date (except in the ordinary course of the Company’s business, or as is reasonably necessary
in connection with the Company’s obligations and contemplated actions set forth in this Stipulation); or (iii) repay any of the Mayne Debt. 

21. The Company represents and warrants that the Company has not sold, canceled, divested, alienated, assigned, or otherwise impaired its
rights to the intellectual property described above in Paragraph 6. Mayne represents and warrants that it will not take any actions to cause the Company to sell, cancel, divest, alienate, assign, or otherwise impair the Company’s rights to the
intellectual property described above in Paragraph 6. 
 22. The Company represents and warrants that the Company will operate in the
ordinary course until the Effective Date, and that the Company shall not dispose of or impair any of its material assets or incur any additional debt or obligations other than as provided in Paragraph 20. Mayne represents and warrants that it will
not take any actions to cause the Company (i) not to operate in the ordinary course until the Effective Date or (ii) to dispose of or impair any of the Company’s material assets or incur any additional debt or obligations other than
as provided in Paragraph 20. 

  
 25 

 23. The Company represents and warrants that the Certificate of Incorporation, amended as of
August 14, 2019, and the Second Amended and Restated Bylaws of the Company, attached as exhibits to the Company’s Annual Report on Form 10-K filed on March 26, 2021, are the Company’s
operative certification of incorporation and bylaws as of the date of this Stipulation. Defendants agree that neither Mayne nor the Individual Defendants shall take any action to further amend the certification of incorporation or bylaws after the
date of this Stipulation. 
 24. Mayne represents and warrants that, except as expressly provided in Paragraph 10 herein and apart from the
Mayne Debt and Mayne Short-Term Financing, it is not aware of, and will not seek to enforce payment of, any amounts or obligations owed by the Company to Mayne or its affiliates incurred prior to the Effective Date, including, but not limited to,
any cash received for royalties in advance of being earned, dividends payable, notes payable, interest payable, loans, or debt financing. 

  
 26 

 RELEASE OF CLAIMS 

25. Effective upon the Effective Date: 

(a) The Plaintiffs’ Releasors shall fully, finally, and forever release and discharge each and all of the Defendants’ Releasees from
any and all of Plaintiffs’ Released Claims. 
 (b) The Defendants’ Releasors shall fully, finally, and forever release and
discharge each and all of the Plaintiffs’ Releasees from any and all of Defendants’ Released Claims. 
 26. The contemplated
releases given by the Releasing Parties extend to Unknown Claims. The Releasing Parties shall be deemed to have waived any and all provisions, rights, and benefits conferred by any law of the United States, any law of any state, or principle of
common law that governs or limits a person’s release of unknown claims to the fullest extent permitted by law. The Releasing Parties shall be deemed to relinquish, to the full extent permitted by law, the provisions, rights, and benefits of
Section 1542 of the California Civil Code, which provides: 
 A GENERAL RELEASE DOES NOT EXTEND TO CLAIMS THAT THE CREDITOR OR RELEASING
PARTY DOES NOT KNOW OR SUSPECT TO EXIST IN HIS OR HER FAVOR AT THE TIME OF EXECUTING THE RELEASE AND THAT, IF KNOWN BY HIM OR HER, WOULD HAVE MATERIALLY AFFECTED HIS OR HER SETTLEMENT WITH THE DEBTOR OR RELEASED PARTY. 

  
 27 

 27. The Releasing Parties shall also be deemed to have waived any and all provisions,
rights, and benefits conferred by any law of any state of the United States or principle of common law that is similar, comparable, or equivalent to California Civil Code Section 1542. The Releasing Parties acknowledge that they may discover
facts in addition to or different from those that they now know or believe to be true with respect to the subject matter of the contemplated releases, but that it is their intention to fully, finally, and forever settle and release any and all
claims released hereby, known or unknown, suspected or unsuspected, which now exist or heretofore existed, from the beginning of time to the Effective Date, without regard to the subsequent discovery or existence of such additional or different
facts, to the fullest extent permitted by law. 
 28. The contemplated releases are not intended to release and shall not be deemed to
release any rights or obligations of the Parties created by this Stipulation. 
 DUE DILIGENCE; CONDITIONS OF THE SETTLEMENT

 29. The Settlement was preceded by production to Plaintiffs and their counsel of books and records pursuant to the
Section 220 Demands; the review of documents produced in discovery; the analysis by Plaintiffs of public filings by the Company with the U.S. Securities and Exchange Commission; the review by Plaintiffs of press releases issued by the Company
and other public statements about 

  
 28 

 
the Company; and the mediation submissions prepared by the Parties. Accordingly, in determining to enter into this Settlement, Plaintiffs believe that they were sufficiently informed of the
circumstances and terms of the Challenged Transactions and Defendants’ actions to determine whether the Settlement was in the best interests of the Company, the Class, and the Company Stockholders (other than Mayne and the Individual
Defendants). 
 30. This Stipulation shall be terminated, and shall be void and of no force and effect, unless otherwise agreed to by the
Parties hereto pursuant to the terms hereof, if (i) any Party exercises a right to terminate the Settlement pursuant to the terms of this Stipulation; or (ii) the Settlement does not obtain Final Court Approval (as defined below). If this
Stipulation is terminated, this Stipulation and the Settlement shall be void and of no effect, and this Stipulation shall not be deemed to prejudice in any way the positions in the Actions of any Party. In such event, and consistent with the
applicable evidentiary rules, neither this Stipulation nor any of its contents, nor the existence of this Stipulation, shall be admissible in evidence or shall be referred to for any purpose in the Actions or in any other proceeding, except in
connection with any claim for breach of this Stipulation or as otherwise specifically provided herein. 

  
 29 

 31. The Settlement shall be void and of no force and effect if the terms of the Settlement,
except for the Fee and Expense Applications (as defined below), do not receive Final Court Approval (as defined below), in which case the Parties shall revert to their litigation positions prior to entering into this Stipulation. For the avoidance
of doubt, the Parties agree that court approval of the Fee and Expense Applications (as defined below) is not a condition precedent to the Settlement or Final Court Approval thereof. 

32. In the event that any final injunction, decision, order, judgment, determination, or decree is entered or issued by any court or
governmental entity prior to Final Court Approval (as defined below) of this Stipulation and the Settlement embodied herein that would make consummation of the Settlement in accordance with the terms of this Stipulation unlawful or that would
restrain, prevent, enjoin, or otherwise prohibit consummation of the Settlement, the Parties each reserve the right to withdraw from and to terminate the Settlement. In addition, in the event that any preliminary or temporary injunction, decision,
order, determination, or decree (an “Interim Order”) is entered or issued by any court or governmental entity prior to Final Court Approval (as defined below) of this Stipulation and the Settlement that would restrain, prevent, enjoin, or
otherwise prohibit consummation of the Settlement, then, notwithstanding anything herein to the contrary, the Parties shall have no obligation to consummate the Settlement unless and until such Interim Order expires or is terminated or modified in a
manner such that consummation of the Settlement in accordance with the terms of this Stipulation would no longer be restrained, prevented, enjoined, or otherwise prohibited. 

  
 30 

 33. The Settlement shall be conditioned upon (i) entry of a Final Order and Judgment
(the “Judgment”) in the form attached as Exhibit B, which shall release any and all claims described in Paragraphs 25-28 hereof (the “Settled Claims”); and (ii) the Judgment becoming
Final (as defined below) (“Final Court Approval”). 
 SUBMISSION AND APPLICATION TO THE COURT 

34. Within two (2) days of the execution of this Stipulation on behalf of all Parties, Plaintiffs’ counsel shall submit this
Stipulation together with its Exhibits to the Court, and the Parties shall apply jointly for entry of an order (the “Scheduling Order”), substantially in the form attached hereto as Exhibit A, providing for, among other things:
(i) approval of the form and content of the proposed Notice of the Settlement; and (ii) a date for the final settlement hearing (the “Settlement Hearing”). At the Settlement Hearing, the Parties shall jointly request that the
Judgment be entered substantially in the form attached as Exhibit B. 

  
 31 

 NOTICE 

35. The Company shall be responsible for providing Notice of the Settlement to Company Stockholders and all members of the Class in the
form and manner directed by the Court (when approved by the Court, the “Notice”), substantially in the form attached hereto as Exhibit C. The Company shall cause to be paid all costs and expenses incurred in providing the Notice, including
any costs and expenses associated with any additional copies of the Notice requested by record holders of the Company’s common stock (whether for purpose of providing the Notice to beneficial owners or otherwise). 

EFFECTIVE DATE/FINAL COURT APPROVAL 

36. The “Effective Date” of the Settlement shall be the first date by which the Court has entered the Judgment and such Judgment has
received Final Court Approval. “Final Court Approval” of any Court Order shall mean (i) if no appeal is filed, the expiration date of the time for filing or noticing of any appeal of the Judgment; or (ii) if there is an appeal
from the Judgment, the date of (a) final dismissal of all such appeals, or the final dismissal of any proceeding on certiorari or otherwise to review the Judgment, or (b) the date the Judgment is finally affirmed on appeal, the expiration
of the time to file a petition for a writ of certiorari or other form of review, or the denial of a writ of certiorari or other form of review of the Judgment, and, if certiorari or other form of review is granted, the date of final affirmance of
the Judgment after such review. Notwithstanding anything to the contrary herein, any appeal or proceeding seeking subsequent judicial review pertaining solely to an order issued with respect to attorneys’ fees or expenses and/or an incentive
award payable to Plaintiffs shall not in any way delay the Effective Date of the Settlement. 

  
 32 

 INTERIM INJUNCTION 

37. Subject to an order of the Court, pending final determination of whether the Settlement should be approved, the Parties shall be barred
and enjoined, to the maximum extent permitted under law, from commencing, prosecuting, instigating, or in any way participating in the commencement or prosecution of any action asserting any of the Released Claims as defined herein, either directly,
representatively, derivatively, or in any other capacity, and all pending deadlines in any and all such actions shall be suspended. 

ATTORNEYS’ FEES AND EXPENSES 

38. Hedgepath, LLC intends to petition the Court for an award of attorneys’ fees and expenses actually incurred by it in connection with
investigating and pursuing the claims asserted in the Actions (and to reimburse Hedgepath, LLC for the attorneys’ fees and expenses already paid to its counsel), and Sears also intends to petition the Court for an award of attorneys’ fees
and expenses. Any attorneys’ fees and expenses awarded by the Court shall be paid solely from the Cash Consideration, and from no other source, in an aggregate amount not to exceed $2,000,000 (United States Dollars) (the “Fee and
Expense Applications”). 

  
 33 

 39. Plaintiffs’ Counsel’s Fee and Expense Applications are not the subject of any
agreement among Plaintiffs and Defendants other than what is set forth in this Stipulation. Defendants agree that they will not object to or otherwise take any position on the Fee and Expense Applications so long as the Fee and Expense Applications
seek an award or reimbursement in an amount no greater than $2,000,000 (United States Dollars).
 40. Plaintiffs’ Counsel’s
attorneys’ fees and expenses that are awarded by the Court (the “Fee and Expense Reimbursement”) will be paid to Plaintiffs’ Counsel and Plaintiffs (to the extent they have already paid such fees to their counsel) from the
Cash Consideration. 
 41. An award of attorneys’ fees or expenses to Plaintiffs or Plaintiffs’ counsel is not a necessary term of
the Settlement and shall not be a condition of the Settlement. Neither Plaintiffs nor Plaintiffs’ counsel may cancel or terminate the Settlement based on the Court’s or any appellate court’s ruling on attorneys’ fees or expenses
or incentive awards to Plaintiffs. 
 42. Except as provided in this Stipulation, the Defendants’ Releasees and the Company shall bear
no other expenses, costs, damages, or fees alleged or incurred by any of Plaintiffs’ counsel, or by any attorneys, experts, advisors, agents, or representatives of any Plaintiff or Class Member in connection with the Actions, the Settled
Claims, or the Settlement. The Plaintiffs’ Releasees shall bear no expenses, costs, damages, or fees alleged or incurred by any Defendant, or by any of any Defendants’ attorneys, experts, advisors, agents or representatives in connection
with the Actions, the Settled Claims, or the Settlement. 

  
 34 

 TERMINATION 

43. Prior to the Effective Date, each Party shall have the right to terminate the Settlement and this Stipulation by providing written notice
of their election to do so, through counsel, to all other Parties hereto within thirty (30) calendar days of: (a) the Court’s final refusal to enter the Scheduling Order in any material respect; (b) the Court’s refusal to
approve (including at the Settlement Hearing) the Settlement or any material part thereof; (c) the Court’s refusal to enter the Judgment in any material respect or to dismiss the Actions with prejudice; (d) the date upon which an
order vacating, modifying, revising or reversing the Judgment becomes Final; or (e) the date upon which Plaintiffs become aware that any of the representations and warranties provided in Paragraphs 16–24 are not true and correct as of the
date of this Stipulation. 
 44. In the event that the Settlement is terminated pursuant to the terms of this Stipulation or the Effective
Date of the Settlement otherwise fails to occur, then: (i) this Stipulation, and the Settlement, including without limitation the releases under Paragraphs 25–28 above, shall be void; (ii) the fact of the Settlement shall not be
admissible in any trial of the Action; (iii) the Parties shall be deemed to have returned to their respective litigation positions in the Actions immediately prior to the date of execution of the Stipulation; and (iv) the Parties shall
proceed in all respects as if this Stipulation and any related orders had not been entered. 

  
 35 

 ENTIRE AGREEMENT 

45. This Stipulation and its Exhibits constitute the entire agreement among the Parties with respect to the subject matter hereof and
supersede all written or oral communications, agreements, or understandings that may have existed prior to the execution of this Stipulation. No representations, warranties, or statements of any nature whatsoever, whether written or oral, have been
made to or relied upon by any Party concerning this Stipulation or its Exhibits, other than the representations, warranties, and covenants expressly set forth in such documents. 

CONSTRUCTION 
 46.
This Stipulation shall be construed in all respects as jointly drafted and shall not be construed, in any way, against any Party on the ground that the Party or its counsel drafted this Stipulation. 

47. Headings have been inserted for convenience only and will not be used in determining the terms of this Stipulation. 

  
 36 

 GOVERNING LAW; CONTINUING JURISDICTION 

48. This Stipulation and the Settlement shall be governed by and construed in accordance with the laws of the State of Delaware without regard
to Delaware’s principles governing choice of law. The Parties irrevocably and unconditionally (i) consent to submit to the sole and exclusive jurisdiction of the Court of Chancery of the State of Delaware for any litigation arising out of
or relating in any way to this Stipulation or the Settlement (or if subject-matter jurisdiction is lacking, to the Superior Court of the State of Delaware); (ii) agree that any dispute arising out of or relating in any way to this Stipulation
or the Settlement shall not be litigated or otherwise pursued in any forum or venue other than any such court; (iii) waive any objection to the laying of venue of any such litigation in any such court; (iv) agree not to plead or claim in
any such court that such litigation brought therein has been brought in any inconvenient forum; and (v) expressly waive any right to demand a jury trial as to any such dispute. 

AMENDMENTS 
 49.
This Stipulation may be modified or amended only by a writing, signed by each of the Parties (or their duly authorized counsel), that refers specifically to this Stipulation. 

  
 37 

 SETTLEMENT NOT AN ADMISSION 

50. The provisions contained in the Settlement and this Stipulation shall not be deemed a presumption, concession, or admission by any Party
to this Stipulation of any fault, liability, or wrongdoing, or any infirmity or weakness of any claim or defense, as to any facts or claims (including the Settled Claims) that have been or might be alleged or asserted in the Actions, or any other
action or proceeding that has been, will be, or could be brought, and shall not be interpreted, construed, deemed, invoked, offered, or received in evidence or otherwise used by any person in the Actions, or in any other action or proceeding,
whether civil, criminal, or administrative, for any purpose other than as permitted by applicable court rules and rules of evidence. 

MISCELLANEOUS PROVISIONS 

51. All the exhibits attached hereto are incorporated by reference as though fully set forth herein. Notwithstanding the foregoing, if there
exists a conflict or inconsistency between the terms of this Stipulation and the terms of any exhibit attached hereto, the terms of the Stipulation shall prevail. 

52. Each of the Defendants warrants that, as to the payments made or to be made on behalf of them, at the time of entering into this
Stipulation and at the time of such payment they, or to the best of their knowledge any Persons contributing to the payment of the Cash Consideration, were not insolvent, nor will the payment required to be made by or on behalf of them render them
insolvent, within the meaning of and/or for the purposes of the United States Bankruptcy Code, including §§ 101 and 547 thereof. This representation is made by each of Defendants and not by their counsel. 

  
 38 

 53. In the event of the entry of a final order of a court of competent jurisdiction
determining that the transfer of the Cash Consideration or any portion thereof by or on behalf of Defendants was a preference, voidable transfer, fraudulent transfer, or similar transaction and any portion thereof is required to be returned, and
such amount is not promptly transferred to the Company by others, then, at the election of Plaintiffs, Plaintiffs and Defendants shall jointly move the Court to vacate and set aside the Released Claims given and the Judgment entered pursuant to this
Stipulation, in which event the Released Claims and Judgment shall be null and void, and Plaintiffs and Defendants shall be restored to their respective positions in the litigation as provided in Paragraph 44 above. 

54. If any Party is required to give notice to another Party under this Stipulation, such notice shall be in writing and shall be deemed to
have been duly given upon receipt of FedEx or email transmission, with confirmation of receipt. Notice shall be provided as follows: 

  
 39 

			
	If to Plaintiffs or Plaintiffs’ Counsel:	  	 Potter Anderson & Corroon LLP
 Attn:
Kevin R. Shannon
 Attn: Tyler J. Leavengood
 1313 North Market
Street – 6th Floor
 Wilmington, DE 19801

(302) 984-6000

kshannon@potteranderson.com
 tleavengood@potteranderson.com

Andrews & Springer LLC
  

Attn: Peter B. Andrews
 4001 Kennett Pike, Suite 250

Wilmington, Delaware 19807
 (302)
504-4957
 pandrews@andrewsspringer.com

	If to Defendants:	  	
		
	 Mayne:
	  	 Mayne Pharma Ventures Pty Ltd.
 Attn: Laura
Loftus
 Level 1, 99 King Street
 Melbourne VIC 3000
Australia
 Laura.Loftus@maynepharma.com
  

Abrams & Bayliss LLP
 Attn: A. Thompson Bayliss

20 Montchanin Road, Suite 200
 Wilmington, DE 19807

Bayliss@AbramsBayliss.com
  

Curtis, Mallet-Prevost, Colt & Mosle LLP
 Attn: Jacques
Semmelman
 101 Park Avenue
 New York, NY 10178

jsemmelman@curtis.com

  
 40 

			
	Brendan Magrab, Stefan J. Cross, Dr. R. Dana Ono, Robert D. Martin, W. Mark Watson, and Nicholas J. Virca:	  	 Wilson Sonsini Goodrich & Rosati
 Attn:
Andrew D. Cordo
 222 Delaware Avenue, 8th Floor
 Wilmington, DE
19801
 (302) 304-7600

acordo@wsgr.com

		
	Nominal Defendant:	  	 Inhibitor Therapeutics, Inc.
 Attn: Garrison
Hasara
 449 South 12th Street

Unit 1705
 Tampa, Florida 33602

(888) 841-6811

ghasara@inhibitortx.com
  

Ashby & Geddes, PA
 Attn: Troupe Mickler

500 Delaware Avenue
 P.O. Box 1150

Wilmington, DE 19899
 (302)
654-1888
 tmickler@ashbygeddes.com

 BINDING EFFECT 

55. This Stipulation shall be binding upon and inure to the benefit of the Parties hereto and their respective agents, executors, heirs,
successors, and assigns. 
 COUNTERPARTS 

56. This Stipulation may be executed in one or more counterparts, each of which when so executed and delivered shall be deemed to be an
original but all of which together shall constitute one and the same instrument. 

  
 41 

 AUTHORITY 

57. This Stipulation will be executed by counsel for each of the Parties, each of whom represents and warrants that they have the authority
from their client(s) to enter into this Stipulation and bind their clients hereto. 
 NO WAIVER 

58. Any failure by any Party to insist upon the strict performance by any other Party of any of the provisions of this Stipulation shall not
be deemed a waiver of any of the provisions hereof, and such Party, notwithstanding such failure, shall have the right thereafter to insist on the strict performance of any and all of the provisions of this Stipulation to be performed by such other
Party. No waiver, express or implied, by any Party of any breach or default in the performance by the other Party of its obligations under this Stipulation shall be deemed or construed to be a waiver of any other breach, whether prior, subsequent,
or contemporaneous, under this Stipulation. 
 CONFIDENTIALITY 

59. Plaintiffs, Defendants, and their counsel agree, to the extent permitted by law, that all agreements relating to the confidentiality of
information made before and during the course of the Actions shall survive this Stipulation. The parties agree that all non-public information relating to the use of SUBA-Itraconazole to treat oncology shall
be deemed the confidential information of Mayne and shall be kept confidential pursuant to the terms of the Third Amended SLA. 

  
 42 

 60. IN WITNESS WHEREOF, the Parties have caused this Stipulation to be executed, by
their duly authorized attorneys, as of September 9, 2022. 

  
 43 

					
	 POTTER ANDERSON &
 CORROON LLP

 
 /s/ Kevin R. Shannon

Kevin R. Shannon (#3137)
 Tyler J. Leavengood (#5506)

Hercules Plaza, 6th Floor

1313 North Market Street
 Wilmington, DE 19899

(302) 984-6000
  

Attorneys for Plaintiff Hedgepath, LLC
	 		 	 ANDREWS & SPRINGER LLC

    
  

/s/ Peter B. Andrews

Peter B. Andrews (#4623)
 Craig J. Springer (#5529)

David Sborz (#6203)
 4001 Kennett Pike, Suite 250

Wilmington, Delaware 19807
 (302)
504-4957
  
 Attorneys for Plaintiff Samuel
Sears

			
	 Of Counsel:
  

Jacques Semmelman
 Grace E. Condro

CURTIS, MALLET-PREVOST, COLT & MOSLE LLP
 101 Park
Avenue
 New York, NY 10178
 (212) 696-6000
	 		 	 ABRAMS & BAYLISS LLP
  

/s/ A. Thompson Bayliss

A. Thompson Bayliss (#4379)
 20 Montchanin Road, Suite 200

Wilmington, DE 19807
 (302)
778-1000
  
 Attorneys for Defendant Mayne
Pharma Ventures Pty Ltd.

			
		 		 	 WILSON SONSINI GOODRICH &
 ROSATI, P.C.

 
 /s/ Andrew D. Cordo

Andrew D. Cordo (#4534)
 Daniyal M. Iqbal (#6167)

Leah E. León (#6536)
 222 Delaware Avenue, Suite 800

Wilmington, Delaware 19801
 (302)
304-7600
  
 Attorneys for Defendants
Brendan Magrab, Stefan J. Cross, Dr. R. Dana Ono, Robert D. Martin, W. Mark Watson, and Nicholas J. Virca

  
 44 

					
		 		 	 ASHBY & GEDDES, P.A.
  

/s/ F. Troupe Mickler IV

F. Troupe Mickler IV (#5361)
 Marie M. Degnan (#5602)

500 Delaware Avenue, 8th Floor

P.O. Box 1150
 Wilmington, Delaware 19801

(302) 654-1888
  

Attorneys for Nominal Defendant Hedgepath Pharmaceuticals, Inc.

			
	 Dated: September 9, 2022
	 		 	
			
		 		 	              

  
 45EX-10.2

 Exhibit 10.2 

Licence Agreement     
  

Date 
 Parties 

 

			
	Name	  	 Mayne Pharma Ventures Pty Ltd, an Australian company ACN 168

896 357

		
	Short form name	  	Mayne Pharma
		
	Notice details	  	 1538 Main North Road, Salisbury South, SA 5106 Australia

Facsimile: +61 3 9614 7022
 Attention: General
Counsel

		
	Name	  	Inhibitor Therapeutics, Inc., formerly known as Hedgepath Pharmaceuticals, Inc., a company incorporated in Delaware, successor in interest by merger to Commonwealth Biotechnologies, Inc, a Virginia corporation
		
	Short form name	  	INTI
		
	Notice details	  	 900 W. Platt St. #200, Tampa, FL 33606, United States

Facsimile: +1 813-527-0500

Attention: CEO

 Background 
  

	A	 Mayne Pharma and INTI are parties to the Third Amended and Restated Supply and License Agreement dated
17 December 2018 (the 2018 Agreement). 

  

	B	 Mayne Pharma and INTI are parties to a certain Stipulation and Agreement of Compromise, Settlement and Release
dated as of September 9, 2022 pending approval by the Court of Chancery of the State of Delaware (the Stipulation), pursuant to which the 2018 Agreement is to be voided as of the Effective Date (defined) except as provided in the
Stipulation, including with respect to the licence to Mayne Pharma of rights arising under certain INTI Patents (defined) and INTI’s right to a 9% cash royalty on future net sales, if any, of the Product (defined) in the United States
and Mayne Pharma’s right to set off any royalties due to INTI on future net sales of the Product against USD 3,000,000.00 advance paid to INTI under the 2018 Agreement. 

 

	C	 In accordance with the Stipulation, Mayne Pharma and INTI have mutually agreed to the following terms and
conditions to provide and govern the licence to Mayne Pharma of rights under of the INTI Patents upon the final approval of the Stipulation and effective as of the Effective Date. If the Stipulation is not approved by December 31, 2022, this
Licence Agreement shall not become effective and the 2018 Agreement shall not be voided. 

  

 Agreed terms 
  

	1.	 Defined terms 

In this Licence Agreement: 

2018 Agreement has the meaning given to it in paragraph A of the background section of this Licence Agreement. 

Actual Launch Date means the date of the first commercial sale of a BCCNS Product in the Territory. 

Affiliate means, with respect to a party, any person or entity which directly or indirectly, is controlled by, controls, or is under
common control with that party. 
 BCCNS means Basal Cell Carcinoma Nevus (Gorlin) Syndrome. 

BCCNS Field means the treatment of human patients with BCCNS. 

BCCNS Product means a Product manufactured or sold by Mayne Pharma in the BCCNS Field. 

Effective Date has the meaning given to it in the Stipulation. 

INTI Patents means the patents listed on Schedule 1. 

Licence Agreement means this license agreement. 

Product means SUBA-Itraconazole as described in Schedule 2 or another SUBA- Itraconazole product. 

Quarter means a 3-month period starting 1 January, 1 April, 1 July or 1 October. 

Relevant Regulatory Authority means, in relation to a country or region, any governmental authority (whether federal, state or local)
regulating the manufacture, importation, storage, promotion, sale, distribution or use of therapeutic substances, and in the case of Australia and the USA incudes the Therapeutic Goods Administration (TGA) and the Food and Drug Administration
(FDA), respectively, or any successor body. 
 Royalty Term means a period beginning on the Actual Launch Date and continuing
until the lapse or expiration of all of the INTI Patents. 
 Territory means the United States of America, including all of its
territories and possessions. 
 Stipulation has the meaning given to it in paragraph B of the background section of this Licence
Agreement. 
  

	2.	 Termination of 2018 Agreement 

 

	2.1	 Acknowledgment. 

The parties acknowledge the termination of the 2018 Agreement and all of their rights and obligations thereunder as of the Effective Date
except as expressly preserved herein. 

	3.	 Licence 

  

	3.1	 Grant of licence to INTI Patents 

From the Effective Date, INTI grants to Mayne Pharma a worldwide, royalty-free (subject to clause 6.1), nonexclusive, perpetual, irrevocable
licence to exploit the INTI Patents to the extent they relate to, or have potential application in connection with, the Product. 
  

	3.2	 Covenant not to sue 

The parties covenant as follows: 
  

	 	(a)	 INTI covenants that it will not sue Mayne Pharma for Mayne Pharma’s use of any information that Mayne
Pharma obtained from INTI in the course of negotiation or performance of the 2018 Agreement or its predecessor agreements, provided the use of such information is not in violation of this Agreement. 

 

	 	(b)	 Mayne Pharma covenants that it will not sue INTI for INTI’s use of any information that INTI obtained from
Mayne Pharma in the course of negotiation or performance of the 2018 Agreement or its predecessor agreements, provided the use of such information is not in violation of this Agreement. 

 

	3.3	 Warranty 

INTI warrants that it is free to grant the licence under clause 3.1 and that, to INTI’s knowledge, there are no claims that the
manufacture, sale or use of any Product constitutes an infringement of the intellectual property rights of any other party. Promptly on becoming aware of any restriction on such right to grant such licence, INTI shall notify Mayne Pharma. 

 

	3.4	 Sub-licensing 

Mayne Pharma may not grant a sublicence of the INTI Patents to a third party without the prior written consent of INTI, which consent shall not
be unreasonably withheld or delayed. Without limiting the foregoing, Mayne Pharma agrees that it would not be unreasonable for INTI to withhold consent if, in the business judgment of the Board of Directors of INTI, Mayne Pharma’s grant of a
sublicence to a third party may cause economic damage to INTI. In no event shall any sublicense alter, impair, avoid, or reduce any obligation owed by Mayne Pharma, including with respect to the payment of any Royalty pursuant to Section 6.

  

	3.5	 Assignment 

Mayne Pharma may assign any of its rights or obligations under this Licence Agreement without the prior written consent of INTI. 

 

	4.	 Termination 

  

	4.1	 Termination for breach by a party 

A party may terminate the surviving obligations set out in this Licence Agreement with immediate effect by notice in the manner set forth below
to the other party if: 
  

	 	(a)	 that other party breaches any material provision of this Licence Agreement and fails to remedy the breach
within 30 days after receiving notice requiring it to do so; or 

  

	 	(b)	 that other party breaches a material provision of this Licence Agreement where that breach is not capable of
remedy. 

	4.2	 Accrued rights and remedies 

The termination or expiry of the 2018 Agreement or this Licence Agreement does not affect any accrued rights or remedies of either party. 

 

	4.3	 Survival 

Sections 3.2, 4, 5, 7 and 8 hereof shall survive any termination of this Licence Agreement. 

Section 3.1 hereof shall survive termination of this Licence Agreement unless it is terminated by INTI for Mayne Pharma’s breach of
Sections 3.2(b) or 3.4. 
 Section 6 hereof shall survive until all royalty payments due from Mayne Pharma to INTI have been paid in
full unless this Licence Agreement is terminated by Mayne Pharma for INTI’s breach of Section 3.2(a). 
  

	5.	 Dispute resolution 

In the event of any action, question or disagreement arising from or relating to the ongoing obligations of the 2018 Agreement or this Licence
Agreement, the parties hereto agree to settle such action, question or disagreement by arbitration before three arbitrators in Wilmington, Delaware, selected by, and such arbitration to be administered by, the American Arbitration Association
(“AAA”) in accordance with its Commercial Arbitration Rules, and judgment on the award rendered by the arbitrator may be entered in any court having jurisdiction thereof. Each of the parties hereto agrees and acknowledges that all actions,
questions or disagreements between or among them arising from or relating to this Agreement are subject to the alternative dispute resolution procedures of this clause 5. Each of the parties hereto agrees that any aspect of alternative dispute
resolution not specifically covered in this Agreement shall be covered, without limitation, by the applicable AAA rules and procedures. Each of the parties hereto further agrees that any determination by the arbitrator regarding any action, question
or disagreement arising from or relating to this Agreement shall be final and binding upon the parties hereto and shall not be subject to further appeal. 
  

	6.	 Royalty 

  

	6.1	 Payment each Quarter 

Subject to clauses 6.2 and 6.3, within 60 days of the end of each Quarter of the Royalty Term, Mayne Pharma must pay to INTI a cash royalty of
9% on the aggregate of the actual gross invoice price for the BCCNS Product sold by Mayne Pharma, its Affiliates or any sublicensee to third parties in the Territory, less the following deductions (whether or not separately stated on invoices) to
the extent reasonable and customary in the market for the Product or any product similar to or substitutable for the Product: 
  

	 	(a)	 Third party trade, case and quantity discounts, bonuses, commission and rebates actually and normally allowed;

  

	 	(b)	 Sales, value added or excise taxes on the sale of such Product; and 

 

	 	(c)	 Amounts repaid or credited to the purchaser by reason of rejections or returns of such Product.

 INTI acknowledges that the royalty payable under this clause reflects the royalty obligation stated in Paragraph 10 of
the Stipulation and is the only royalty obligation from Mayne Pharma to INTI. 

	6.2	 Calculation of the royalty 

In respect of the amounts payable under clause 6.1: 
  

	 	(a)	 if such amount is negative in any Quarter, then no royalty is payable for that Quarter and that amount will be
carried forward and included as a deduction from the aggregate of the gross invoice price in any subsequent Quarter (as applicable); 

  

	 	(b)	 Mayne Pharma must submit to INTI a report setting out, in reasonable detail, the calculation of the royalty
amount (including the aggregate actual gross invoice price for the Product sold by Mayne Pharma, its Affiliates or any sublicensee during the applicable Quarter) at the same time as it makes payment; and 

 

	 	(c)	 Mayne Pharma must, and must ensure that its Affiliates and any sublicensee will, promptly process any deduction
and in any event, process such deductions no later than one Quarter after they are allowed (in the case of discounts, bonuses, commissions and rebates) applied or the Products sold by Mayne Pharma, its Affiliates or any sublicensee are rejected or
returned. 

  

	6.3	 Credit for payment of the Advance 

The parties acknowledge that, as at the date of this Licence Agreement, Mayne Pharma has paid advances totalling USD 3,000,000.00 to INTI.
Royalty payments totalling up to USD 3,000,000.00 that are due by Mayne Pharma to INTI under clause 6.1 will be credited and set off against the advances totalling USD 3,000,000.00, after which any further royalty payments that are due by Mayne
Pharma to INTI under clause 6.1 will be paid in full to INTI. 
  

	6.4	 Books of account 

 

	 	(a)	 Mayne Pharma will maintain books of account and records with respect to sales and stocks of a BCCNS Product in
the Territory by Mayne Pharma, its Affiliates and any sublicensee (including stock records) (Mayne Pharma Books of Account). 

  

	 	(b)	 INTI will have the right to appoint, on reasonable notice, an Accountant to inspect and examine the Mayne
Pharma Books of Account. 

  

	 	(c)	 INTI will bear the fees of such Accountant unless an error equivalent to 5% or more (in favour of INTI) of the
amounts payable under clause 6.1 in any calendar year is discovered, in which case the fees will be borne by Mayne Pharma. 

  

	 	(d)	 Mayne Pharma will maintain the Mayne Pharma Books of Account in accordance with business accounting standards
in the Territory. 

  

	7.	 Payments 

  

	7.1	 Payment terms 

Mayne Pharma must make payments due under this Licence Agreement: 
  

	 	(a)	 in US dollars; and 

  

	 	(b)	 to the bank account of INTI listed on the relevant invoice, with Mayne Pharma to bear the costs of any such
remittance. 

	7.2	 Reimbursement 

Where a party agrees to reimburse to the other party any costs or expenses, then it will reimburse these amounts within 30 days from receipt of
the other party’s invoice for, and reasonable evidence of, such costs or expenses. 
  

	8.	 Miscellaneous 

  

	8.1	 Governing law 

This Licence Agreement is governed by the laws of Delaware, USA, without regard to the conflicts of laws principles thereof. 

 

	8.2	 Entire agreement 

This Licence Agreement and the Stipulation constitute the entire agreement between the parties as to its subject matter and supersedes any
prior representations and agreements in connection with that subject matter. In the event of a conflict between the terms of this Licence Agreement and the Stipulation, the terms of this Licence Agreement shall prevail. 

 

	8.3	 Costs 

Each party must bear its own costs of preparing and executing this Licence Agreement. 

 

	8.4	 Counterparts 

This Licence Agreement may be executed in counterparts, including facsimile counterpart. All executed counterparts constitute one document.

 Signing page     

 
 EXECUTED as an agreement. 

 

							
	Signed for Mayne Pharma Ventures Pty Ltd by an authorised officer in the presence of	 		  	 /s/ shawn Patrick O’Brien
	 	¬
	  	Signature of officer
				
	 /s/ Laura Loftus
	 	¬	  	 shawn Patrick O’Brien
	 	
	 Signature of witness
  

Laura Loftus
	 		  	 Name of officer (print)
  

CEO & MANAGING DIRECTOR
	 	
	Name of witness (print)	 	                	  	Office held	 	        
				
	Signed for Inhibitor Therapeutics, Inc. by an authorised officer in the presence of	 		  	          
	 	¬
	  	Signature of officer
	          
	 	¬	  	          
	 	
	Signature of witness	 		  	Name of officer (print)	 	
	          
	 		  	          
	 	
	Name of witness (print)	 		  	Office held	 	

  

  
 -7- 

 Schedule 1 

INTI Patents 
  

	a.	 U.S. Patent 9,192,609 

Treatment and Prognostic Monitoring of Proliferation Disorders Using Hedgehog Pathway Inhibitors 

Issued: 11-24-2015; Expires:
02-05-2034 
  

	b.	 U.S. Patent 9,962,381 

Treatment and Prognostic Monitoring of Cancerous Proliferation Disorders Using Hedgehog Pathway Inhibitors 

Issued: 05-08-2018; Expires:
02-05-2034 
  

	c.	 U.S. Patent 9,968,600 

Treatment and Prognostic Monitoring of Non-Cancerous Proliferation Disorders Using Hedgehog Pathway
Inhibitors 
 Issued: 05-05-2018; Expires: 02-05-2034 
  

	d.	 U.S. Patent 10,328,072 

Treatment of Lung Cancer Using Hedgehog Pathway Inhibitors 

Issued: 6-25-2019; Expires:
02-05-2034 
  

	e.	 U.S. Patent 10,363,252 

Treatment of Prostate Cancer Using Hedgehog Pathway Inhibitors 

Issued: 07-30-2019; Expires:
02-05-2034 

 Schedule 2 

Product and Product Specification 

Product: SUBA-Itraconazole 50mg hard capsules 
 1.
Description of the dosage form 
 Hard gelatin capsules. size 1, light blue/light blue body and cap printed
“i-50” in black on the cap. Capsules contain white to off-white powder. The outside of the capsule must be free from powder and the two capsule halves must
lock firmly together. 
 2. Composition 
 The qualitative
composition for SUBA-Itraconazole Capsules is presented in Table 1 below. 
 Table 1:Qualitative and Quantitative Composition 

 

			
	 Component
	  	 Grade

	Itraconazole	  	USP/Ph.Eur.
		
	Hypromellose Phthalate (HP-50)	  	NF/Ph.Eur.
		
	Sodium Starch Glycolate Type A	  	NF/Ph.Eur.
		
	Silicon Dioxide Colloidal (Aerosil 200P)	  	NF/Ph.Eur.
		
	Magnesium Stearate (1726)	  	NF/Ph.Eur.
		
	Methylene Chloride	  	NF/Ph.Eur.
		
	Nitrogen	  	NF
		
	 Capsule size No 1 P
  

Light Blue/Light Blue
	  	In-house
		
	FD&C Blue No. 1 (Cl 42090)	  	21 CFR
		
	Titanium Dioxide (CI 77891)	  	21 CFR
		
	Gelatin	  	USP/Ph.Eur.
		
	TekPrint SW-9008	  	Proprietary
		
	Shellac	  	NF
		
	Dehydrated Alcohol	  	USP
		
	Isopropyl Alcohol	  	USP
		
	Butyl Alcohol	  	NF
		
	Propylene Glycol	  	USP
		
	Strong Ammonia Solution	  	NF

			
	Potassium Hydroxide	  	NF
		
	Black Iron Oxide	  	NF
		
	Purified Water	  	USP

 3. Container Closure System 

SUBA-Itraconazole Capsules 50 mg will be packaged into white, round HDPE bottles with CRC/induction foil seal cap containing 30 capsules or 90 capsules (trade
pack). 
 SUBA-Itraconazole Capsules 50 mg may be packaged into double LDPE bag lined cardboard cartons with one desiccant sachet between the inner and outer
bags and each bag sealed with a cable tie. 
  

  
 - 10 -

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