License Agreement by and between the Company and Mayne, dated December 13, 2022

Exhibit 10.2

Licence Agreement    

Date

Parties

Background

Agreed 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.

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.

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.

The parties covenant as follows:

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.

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.

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

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:

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

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).

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.

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:

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.

In respect of the amounts payable under clause 6.1:

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.

Mayne Pharma must make payments due under this Licence Agreement:

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.

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

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.

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

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

Signing page    

EXECUTED as an agreement.

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Schedule 1

INTI Patents

Treatment and Prognostic Monitoring of Proliferation Disorders Using Hedgehog Pathway Inhibitors

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

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

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

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

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

Treatment of Lung Cancer Using Hedgehog Pathway Inhibitors

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

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

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.

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