Exhibit 10.1

Confidential Treatment Requested by HedgePath Pharmaceuticals, Inc.,

IRS Employer Identification No. 30-0793665

Confidential treatment requested with respect to certain portions hereof denoted with “***”

***CONFIDENTIAL TREATMENT REQUESTED***

Final

Date: 3 September 2013

Supply and license agreement – Mayne Pharma and HPPI | page 1

Confidential Treatment Requested by HedgePath Pharmaceuticals, Inc.,

IRS Employer Identification No. 30-0793665

Confidential treatment requested with respect to certain portions hereof denoted with “***”

Table of contents

Supply and license agreement – Mayne Pharma and HPPI | page 2

Confidential Treatment Requested by HedgePath Pharmaceuticals, Inc.,

IRS Employer Identification No. 30-0793665

Confidential treatment requested with respect to certain portions hereof denoted with “***”

Supply and license agreement – Mayne Pharma and HPPI | page 3

Confidential Treatment Requested by HedgePath Pharmaceuticals, Inc.,

IRS Employer Identification No. 30-0793665

Confidential treatment requested with respect to certain portions hereof denoted with “***”

Supply and license agreement – Mayne Pharma and HPPI | page 4

Confidential Treatment Requested by HedgePath Pharmaceuticals, Inc.,

IRS Employer Identification No. 30-0793665

Confidential treatment requested with respect to certain portions hereof denoted with “***”

Supply and license agreement – Mayne Pharma and HPPI | page 5

Confidential Treatment Requested by HedgePath Pharmaceuticals, Inc.,

IRS Employer Identification No. 30-0793665

Confidential treatment requested with respect to certain portions hereof denoted with “***”

Details

Parties

Background

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Confidential Treatment Requested by HedgePath Pharmaceuticals, Inc.,

IRS Employer Identification No. 30-0793665

Confidential treatment requested with respect to certain portions hereof denoted with “***”

Agreed terms

Defined terms & interpretation

In this agreement:

Actual Launch Date means the date of the first commercial sale of the Product in any part of the Field, directly or indirectly, by HPPI.

Adverse Drug Event means any untoward medical occurrence in a patient or clinical investigation subject administered with the Product, including any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the Product, whether or not considered related to the Product.

Affected Obligations is defined in clause 21.1(a)(ii).

Affiliate means, with respect to a party, any person which, directly or indirectly, is controlled by, controls or is under common control with that party. In this definition, control means having the power to exercise or control the right to vote attached to 50% or more of the issued voting equity in that party, to appoint one half or more of the directors to the board or the managers of the party, or to determine substantially the conduct of the party’s business activities.

Alternate Product means any product ***.

API means active pharmaceutical ingredient.

Business Day means:

Business Hours means the hours between 9am and 5pm on a Business Day.

Business Plan is the business plan provided by HPPI under clause 12.1 and updated from time to time in accordance with that clause.

Certificate of Analysis means a document which is signed and dated by an authorised representative of Mayne Pharma containing analysis results and certifying that the Product conforms with the Product Specification.

Commercial Year means a year starting at the start of the first Quarter after the Target Launch Date.

Competing Product means any pharmaceutical product ***.

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Confidential Treatment Requested by HedgePath Pharmaceuticals, Inc.,

IRS Employer Identification No. 30-0793665

Confidential treatment requested with respect to certain portions hereof denoted with “***”

Condition Date means 16 December 2013 as that date may be extended:

Condition means each of the conditions set out in item 1 of Schedule 2.

Confidential Information is defined in clause 17.1.

CPI means the ‘Price Indexes of Materials Used in Manufacturing Industries, Australia’ issued by the Australian Bureau of Statistics using the index figure for chemicals.

Defective Product is defined in clause 9.2.

Delivery Date is defined in clause 6.2(c).

Developed Intellectual Property Rights is defined in clause 18.5.

Development Plan means the plan for the research, development and registration activities relating to the Product, as at the Start Date as set out in Schedule 3, and updated in accordance with clause 4.8(b).

Disclosing Party is defined in clause 17.1.

Dispute is defined in clause 23.2.

Dispute Notice is defined in clause 23.2.

EIP means the 2013 Equity Incentive Plan of HPPI, details of which are set out in Schedule 8.

Field means treatment of human patients with cancer via oral administration. The initial three indications included within the Field shall be prostate, lung and skin cancer, which shall be developed in accordance with the Development Plan. It is agreed that HPPI has the exclusive right hereunder to develop the Product for additional indications in the Field; provided, however, that HPPI may not expand the Field to include any other types of cancer or any other medical indication unless agreed to in advance in writing by Mayne Pharma.

Force Majeure Event means, in relation to a party, anything outside the reasonable control of the party, including:

Forecast is defined in clause 6.1(a).

Forecast Period is set out in Schedule 5.

Good Distribution Practice means the guidelines for the proper distribution of medicinal products for human use in the Territory, including in accordance with 21 CFR 210/211 and USP 1079, as each may be amended from time to time.

Good Manufacturing Practice means the guidelines for the proper manufacture of medicinal products for human use in the Territory, including in accordance with in accordance with 21 CFR 210/211, as may be amended from time to time.

Hedgepath, LLC means a Hedgepath, LLC, a limited liability company organised in the State of Florida.

Supply and license agreement – Mayne Pharma and HPPI | page 8

Confidential Treatment Requested by HedgePath Pharmaceuticals, Inc.,

IRS Employer Identification No. 30-0793665

Confidential treatment requested with respect to certain portions hereof denoted with “***”

HPPI Licensed Rights is defined in item 1 of Schedule 7.

HP Patents means each of US patent application 61/813,122 (prostate-specific antigen as biomarker for hedgehog pathway inhibitor treatment and prognostic monitoring of prostate cancer) and US patent application 61/831,823 (Treatment and Prognostic Monitoring of Cancer Using Hedgehog Pathway Inhibitors) in the name of Hedgepath, LLC and any resulting issued patents whether or not in the Territory, and all continuations-in-part, continuations or divisions of any such patent or patents, or substitutes of it, and any reissues, extensions, or renewals of it, whether or not in the Territory.

Initial Term is set out in Schedule 1.

Intellectual Property Rights means all intellectual property rights subsisting anywhere in the world, including:

whether or not such rights are registered or capable of being registered.

JDC is defined in clause 4.2.

***

Marketing Authorisation means a registration, approval or licence from a Relevant Regulatory Authority in the Territory for the importation, storage, promotion, sale or distribution of the Product in the Field.

MP Licensed Rights means all Intellectual Property Rights in the Product existing as at the Start Date and owned by Mayne Pharma or its Affiliates:

Minimum Annual Volume for the Product is as agreed by the parties in accordance with item 1.2 of Schedule 5.

Minimum Order Quantity means the batch size for the Product as set out in Schedule 5.

***

Off Label Sales is defined in clause 7.3(a).

Order is defined in clause 6.2(a).

Personnel, of a party, means its employees, officers, directors, agents, consultants and contractors (to avoid doubt, such contractors not including the other party).

Precluded Extent is defined in clause 21.1.

Precluded Party is defined in clause 21.1.

Price is set out in Schedule 5.

Supply and license agreement – Mayne Pharma and HPPI | page 9

Confidential Treatment Requested by HedgePath Pharmaceuticals, Inc.,

IRS Employer Identification No. 30-0793665

Confidential treatment requested with respect to certain portions hereof denoted with “***”

Product means the product set out in Schedule 4, and any other product agreed by the parties in writing for the purposes of this agreement from time to time (at which time the parties must also agree in writing related amendments to Schedule 4 and Schedule 5), it being acknowledged and agreed that the term “Product” may include products covering different medical indications developed under the Development Plan, provided the same are included within the scope of the Field.

Product Specification means the specification with respect to the manufacture, packaging, quality and characteristics (including the raw materials and product specification) and testing of the Product, as set out in Schedule 4.

Quality Agreement means the technical agreement between the parties detailing the specification and technical terms for the manufacture of the Product as set out in the Marketing Authorisation.

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

reasonable commercial efforts means ***.

Recipient is defined in clause 17.2.

Relevant Regulatory Authority, in relation to a country or region in or comprising the Territory, means 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 includes the Therapeutic Goods Administration (TGA) and the Food and Drug Administration (FDA) respectively, or any successor body.

Safety Data Exchange Agreement (SDEA) means the agreement between the parties setting out the rules and procedures for exchanging information concerning certain safety and pharmacovigilance issues.

Sales Forecast is set out in item 1.2 of Schedule 5.

Series A Preferred Stock means the Series A Convertible Preferred Stock, par value $0.0001 per share, of HPPI, the terms of which are memorialized in the Certificate of Designation for the Series A Preferred Stock, the form of which has been provided to Mayne Pharma filed with the Secretary of State of Delaware on August 13, 2013, as the same may be amended, restated or corrected from time to time.

Start Date is set out in Schedule 1.

Sub Licensee is defined in clause 3.4.

Tax means any tax (including any GST or VAT), withholding tax, duties, levies, charges, fees and other imposts of any kind (including any fine, interest, penalty and expenses in connection with those items) levied, assessed, charged or collected in connection with this agreement or the performance of services under this agreement, but does not include any income or capital gains tax.

Target Launch Date is defined in clause 4.3, as that date may be extended by agreement of the parties in writing.

Term means the Initial Term and any extensions under clause 2.2.

Territory is set out in Schedule 1.

Trade Mark means US trade mark (number 77793077) “SUBA” for goods and services in class 5 (pharmaceutical and veterinary preparations having enhanced bioavailability excluding pharmaceutical products for the treatment of opioid addiction) and any other trade marks (whether registered or unregistered) notified in writing by Mayne Pharma to HPPI for the purposes of this agreement from time to time.

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Confidential Treatment Requested by HedgePath Pharmaceuticals, Inc.,

IRS Employer Identification No. 30-0793665

Confidential treatment requested with respect to certain portions hereof denoted with “***”

In this agreement, except where the context otherwise requires:

Term

This agreement starts on the Start Date and continues for the Initial Term unless terminated in accordance with its terms and conditions.

This agreement automatically continues after the Initial Term for additional periods of ***, unless a party gives notice of its wish not to extend this agreement at least *** before the end of the Initial Term or any extended term under this clause 2.2 or this agreement is terminated in accordance with its terms and conditions.

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Confidential Treatment Requested by HedgePath Pharmaceuticals, Inc.,

IRS Employer Identification No. 30-0793665

Confidential treatment requested with respect to certain portions hereof denoted with “***”

Licence

Mayne Pharma grants to HPPI an exclusive licence to exploit the Product in the Field in the Territory, including:

which licence:

HPPI must:

Mayne Pharma must not, directly itself or indirectly through any third party, import, promote, market, distribute or sell the Product or any Competing Product in the Territory in the Field during the Term, other than as a result of any off label use of an Alternate Product which the parties acknowledge is outside the reasonable control of Mayne Pharma (but subject to the provisions of clause 7.3 hereof).

HPPI may only grant a sub licence of the MP Licensed Rights and the Trade Mark to a third party (including any Affiliate or approved contractor) (Sub Licensee) with the prior written consent of Mayne Pharma under a written agreement that:

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Confidential Treatment Requested by HedgePath Pharmaceuticals, Inc.,

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and HPPI remains responsible for ensuring its Sub Licensees comply with such written agreement.

Development

which JDC will continue until the Target Launch Date.

Supply and license agreement – Mayne Pharma and HPPI | page 13

Confidential Treatment Requested by HedgePath Pharmaceuticals, Inc.,

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The parties must procure that the Joint Development Committee (acting by a majority of all representatives) nominates the target for the Actual Launch Date (Target Launch Date), and HPPI must notify Mayne Pharma of the Target Launch Date in writing, by ***.

In satisfying any Condition, the parties agree to use reasonable commercial efforts to structure transactions in a tax effective manner.

Each Condition may only be waived in writing signed by Mayne Pharma.

HPPI must give Mayne Pharma notice when a Condition is satisfied.

If all Conditions have not been satisfied by the Condition Date, then unless or until such time as all Conditions are satisfied, Mayne Pharma may terminate this agreement with immediate effect by notice to HPPI, except if there is a genuine dispute regarding the satisfaction of any Condition in which case Mayne Pharma may not terminate this agreement unless or until:

whichever is sooner.

HPPI agrees that any material decisions regarding the following are subject to the prior written consent of Mayne Pharma, such consent not to be unreasonably withheld, conditioned or delayed:

Supply and license agreement – Mayne Pharma and HPPI | page 14

Confidential Treatment Requested by HedgePath Pharmaceuticals, Inc.,

IRS Employer Identification No. 30-0793665

Confidential treatment requested with respect to certain portions hereof denoted with “***”

Marketing Authorisation

HPPI must:

Mayne Pharma will, at HPPI’s cost and expense:

If, notwithstanding HPPI’s compliance with clause 5.1, a Marketing Authorisation has not been obtained by HPPI, any Affiliate or Sub Licensee at least *** before the Target Launch Date, then following consultation with the other party for up to ***, either party, acting reasonably, may terminate this agreement with immediate effect with notice to the other party.

Manufacture and supply of Product

***

Supply and license agreement – Mayne Pharma and HPPI | page 15

Confidential Treatment Requested by HedgePath Pharmaceuticals, Inc.,

IRS Employer Identification No. 30-0793665

Confidential treatment requested with respect to certain portions hereof denoted with “***”

HPPI is entitled to qualify an alternate manufacturer of the Product in accordance with Schedule 6.

Payments

HPPI must make the payments set out in, and comply with, Schedule 5.

***

Supply and license agreement – Mayne Pharma and HPPI | page 16

Confidential Treatment Requested by HedgePath Pharmaceuticals, Inc.,

IRS Employer Identification No. 30-0793665

Confidential treatment requested with respect to certain portions hereof denoted with “***”

Each party must make payments due under this agreement:

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

Delivery, risk and title

Mayne Pharma must deliver the Product to HPPI in accordance with the delivery terms set out in item 3 of Schedule 5. Any Product that HPPI is paying for must have the minimum shelf life specified in item 4 of Schedule 5.

All risk of loss or of damage to the Product will pass to HPPI upon delivery of the Product in accordance with the delivery terms set out in item 3 of Schedule 5.

Title to the Product will pass to HPPI upon payment in full of the Price payable for that Product or if no amount is payable, then on delivery.

Acceptance of Product

Each delivery of the Product will be accompanied by a Certificate of Analysis from Mayne Pharma in respect of the Product so delivered.

Supply and license agreement – Mayne Pharma and HPPI | page 17

Confidential Treatment Requested by HedgePath Pharmaceuticals, Inc.,

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Confidential treatment requested with respect to certain portions hereof denoted with “***”

then HPPI is deemed to have accepted the Product and will reimburse Mayne Pharma for any costs and expenses incurred by Mayne Pharma in attempting to resolve the issue, including the costs of any retention sample testing conducted by Mayne Pharma.

Despite any other provision in this agreement, HPPI’s sole remedy in respect of Product which fails to conform to the Product Specification is, and Mayne Pharma’s liability to HPPI under this agreement will be, limited as set out in clauses 9.2 and 16.3.

Complaints

HPPI must handle all customer complaints relating to any Product in the Territory and any related activities associated with reporting or management of customer complaints.

If HPPI becomes aware of any material complaint in connection with the Product, it must promptly notify Mayne Pharma of the complaint and provide details.

Supply and license agreement – Mayne Pharma and HPPI | page 18

Confidential Treatment Requested by HedgePath Pharmaceuticals, Inc.,

IRS Employer Identification No. 30-0793665

Confidential treatment requested with respect to certain portions hereof denoted with “***”

HPPI must advise Mayne Pharma as soon as reasonably practicable after becoming aware of any Adverse Drug Event.

Recalls

If a party determines any quantity of the Product should be recalled for any reason, or a party is notified of a recall, that party must give the other party notice within the time frames set out in the Safety Data Exchange Agreement of its request to recall that quantity and specify its reasons. If a party determines that to avoid an immediate perceived threat to health, time does not permit the provision of notice, such notice may be made by telephone or e-mail transmission to the other party’s medical affairs liaison and quality contact person to be confirmed in writing after such notice.

If, within *** of the receipt of notice under clause 11.1, the parties are unable to agree on the need to undertake a recall (including after HPPI discusses the issue with the Relevant Regulatory Authority), then either party may direct that the Product be recalled, with or without the agreement of the other party, if it reasonably determines that such recall is necessary to protect the public health or is necessary to ensure compliance with applicable laws, rules and regulations.

HPPI must administer any recall of the Product in the Territory.

If the cause of the recall is because the Product does not conform to the Product Specification, and it is as a result of a breach of warranty or negligence by Mayne Pharma, then Mayne Pharma must, at its expense, reimburse to HPPI for all its reasonable costs and expenses of any recall and the costs of any independent analyst engaged under clause 11.5. Otherwise, all costs and expenses in respect of the recall and the independent analyst are payable by HPPI.

If the parties cannot agree on whether the Product conformed to the Product Specification, then the parties agree to submit a sample of the Product to an independent analyst, acceptable to both parties, for a report. Absent manifest error, the finding of the independent analyst is binding on the parties

Supply and license agreement – Mayne Pharma and HPPI | page 19

Confidential Treatment Requested by HedgePath Pharmaceuticals, Inc.,

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Confidential treatment requested with respect to certain portions hereof denoted with “***”

Performance obligations

From the Target Launch Date:

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Confidential Treatment Requested by HedgePath Pharmaceuticals, Inc.,

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Confidential treatment requested with respect to certain portions hereof denoted with “***”

Compliance with laws and regulations

HPPI must:

Mayne Pharma must:

Supply and license agreement – Mayne Pharma and HPPI | page 21

Confidential Treatment Requested by HedgePath Pharmaceuticals, Inc.,

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Confidential treatment requested with respect to certain portions hereof denoted with “***”

Inspection

Each party must procure that the other party or its authorised representative may, at the other party’s expense and on reasonable notice, visit and inspect the facilities of the first party, its Affiliates, sub licensees or its contractors used in respect of the Product (not more than once per year), to ensure compliance with this agreement.

Representations and warranties

Each party represents and warrants that:

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Confidential Treatment Requested by HedgePath Pharmaceuticals, Inc.,

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Confidential treatment requested with respect to certain portions hereof denoted with “***”

HPPI represents and warrants that:

Supply and license agreement – Mayne Pharma and HPPI | page 23

Confidential Treatment Requested by HedgePath Pharmaceuticals, Inc.,

IRS Employer Identification No. 30-0793665

Confidential treatment requested with respect to certain portions hereof denoted with “***”

Liability, indemnity and insurance

HPPI may have certain rights and remedies that cannot be excluded, restricted or modified by agreement. Nothing in this agreement operates to exclude, restrict or modify the application of any implied condition or warranty, provision, the exercise of any right or remedy, or the imposition of any liability under any law where to do so would contravene that law or cause any term of this agreement to be void (Non-excludable Obligation).

Except for the Non-excludable Obligations and the express covenants, representations and warranties set out in this agreement, MAYNE PHARMA MAKES NO OTHER COVENANTS, REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, INCLUDING THE IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, THE WARRANTY OF NON INFRINGEMENT, OR ANY OTHER MATTER, ANY SUCH COVENANTS, REPRESENTATIONS AND WARRANTIES BEING EXPRESSLY DISCLAIMED.

Mayne Pharma’s liability to HPPI arising directly or indirectly under or in connection with this agreement or the performance or non-performance of this agreement and whether arising under any indemnity, statute, in tort (including for negligence or otherwise (except as provided for below in this clause 16.3)), or on any other basis in law or equity is limited as follows:

***

HPPI must indemnify and hold harmless and keep indemnified and held harmless Mayne Pharma and each of its Personnel from and against all actions, claims, demands, losses, damages, costs and expenses (including legal expenses as between a solicitor and their own client) howsoever and wheresoever arising, whether during or after the Term, which arise directly or indirectly from or in respect of:

except to the extent that such action, claim, demand, loss, damage, cost or expense is caused by a breach of an express warranty given under this agreement by Mayne Pharma or the gross negligence, fraud or wilful misconduct of Mayne Pharma or its Affiliates or Personnel.

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Confidential Treatment Requested by HedgePath Pharmaceuticals, Inc.,

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Confidential treatment requested with respect to certain portions hereof denoted with “***”

Mayne Pharma must effect and maintain product and public liability insurance, with reputable insurers, which provides coverage for at least *** for each occurrence.

Each party must maintain the insurance policies referred to in clause 16.5 or 16.6 (as applicable) throughout the Term and, in the case of a claims-based policy, until *** after the termination or expiry of this agreement.

Promptly in response to a request by a party, the other party must provide to the requesting party evidence of the currency of the insurance policies referred to in clause 16.5 or 16.6 (as applicable).

Confidentiality

Subject to clause 17.3, Confidential Information of a party (in this context, the Disclosing Party) means all information regardless of its form:

and any derived information from which that information can reasonably be ascertained. Without limiting the generality of the foregoing, Confidential Information shall include, information and materials related to Product, processes, formulations, procedures, tests, equipment, data, batch

Supply and license agreement – Mayne Pharma and HPPI | page 25

Confidential Treatment Requested by HedgePath Pharmaceuticals, Inc.,

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Confidential treatment requested with respect to certain portions hereof denoted with “***”

records, reports, know-how, patent positioning, relationships with consultants and employees, business plans and business developments, and information concerning the existence, scope or activities of any research, design, development, manufacturing, marketing or other activities hereunder or otherwise relating to the Disclosing Party or its business.

Subject to the exceptions and permitted disclosures set out below, each party (Recipient) agrees:

except that each party may share such Confidential Information with any Affiliate, sub licensee or approved contractors to the extent necessary or reasonably desirable for the purposes of this agreement, provided each party remains responsible for ensuring such Affiliates, sub licensees or contractors comply with restrictions on use and disclosure of information which are at least equivalent to those set out in this agreement, without any right of further disclosure.

The restrictions on use and disclosure set out above do not apply to the extent the Recipient can show the information:

Intellectual Property Rights

HPPI acknowledges and agrees that Mayne Pharma owns all Intellectual Property Rights in the Product existing as at the Start Date other than the HP Patents, HPPI Licensed Rights or any Intellectual Property Rights developed exclusively by HPPI or its Affiliates or Personnel prior to the Start Date.

***

***

Supply and license agreement – Mayne Pharma and HPPI | page 26

Confidential Treatment Requested by HedgePath Pharmaceuticals, Inc.,

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Confidential treatment requested with respect to certain portions hereof denoted with “***”

***

Each party will immediately notify the other party if it becomes aware of potential or actual:

Each party has the sole right at its own expense to take action in respect of any potential or actual infringement of Intellectual Property Rights it owns, regardless of the grant of any rights, exclusive or otherwise, to the other party under this agreement. In response to a request by a party taking such action, the other party will provide information and assistance in connection with such potential or alleged infringement to the extent it relates to the Intellectual Property Rights which are the subject of this agreement, and the requesting party will reimburse to the other party all reasonable costs and expenses incurred as a result.

Branding

HPPI may use the Trade Mark in connection with its promotion, marketing, sale and distribution of the Product in the Territory, and must observe all directions notified to it by Mayne Pharma regarding the depiction of its Trade Marks.

HPPI must submit to Mayne Pharma samples of all materials (including all advertisements, promotions and other marketing material for the Product) that depict the Trade Mark for approval by Mayne Pharma before use.

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Confidential Treatment Requested by HedgePath Pharmaceuticals, Inc.,

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Confidential treatment requested with respect to certain portions hereof denoted with “***”

HPPI must not, whether during the Term or after the end of this agreement:

HPPI acknowledges that any goodwill and other such rights in the Trade Marks that may otherwise accrue to HPPI as a result of its use of the Trade Mark, accrue to the benefit of Mayne Pharma.

HPPI must not, whether during the Term or after the end of this agreement, apply to register anywhere in the Territory or the world any trade mark, or apply to register or use any business name, company name or Internet domain name that comprises or contains the Trade Mark or any words or images that are similar to the Trade Mark without the prior written consent of Mayne Pharma.

Termination

A party may terminate this agreement with immediate effect by notice in the manner set forth below to the other party if:

Mayne Pharma may terminate this agreement with immediate effect by notice to HPPI if:

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Confidential Treatment Requested by HedgePath Pharmaceuticals, Inc.,

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Confidential treatment requested with respect to certain portions hereof denoted with “***”

Each party must notify the other party immediately if:

***

The termination or expiry of this agreement does not affect any accrued rights or remedies of either party.

At the termination or expiry of this agreement except for termination by Mayne Pharma under clause 20.1 or 20.2:

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Confidential Treatment Requested by HedgePath Pharmaceuticals, Inc.,

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Confidential treatment requested with respect to certain portions hereof denoted with “***”

At the termination or expiry of this agreement for any reason whatsoever:

Force majeure

If a Force Majeure Event affecting a party precludes that party (Precluded Party) partially or wholly from complying with its obligations (except its payment obligations) under this agreement then:

If the suspension under clause 21.1(b) continues for more than ***, the other party may terminate this agreement with immediate effect by giving notice to the Precluded Party.

Supply and license agreement – Mayne Pharma and HPPI | page 30

Confidential Treatment Requested by HedgePath Pharmaceuticals, Inc.,

IRS Employer Identification No. 30-0793665

Confidential treatment requested with respect to certain portions hereof denoted with “***”

Notices and other communications

A notice, demand, consent, approval or communication under this agreement (Notice) must be:

A Notice given in accordance with clause 22.1 takes effect when taken to be received (or at a later time specified in it), and is taken to be received:

but if the delivery, receipt or transmission is not on a Business Day or is after 5.00pm on a Business Day, the Notice is taken to be received at 9.00am on the next Business Day.

Dispute resolution

A party must not start arbitration or court proceedings (except proceedings seeking interlocutory relief) unless it has complied with this clause 0.

A party claiming that a dispute, controversy or claim arising out of or relating to this agreement, or the breach, termination or invalidity of it has arisen (Dispute) must give the other party notice of the details of the Dispute (Dispute Notice).

The parties must attempt to resolve any Dispute by negotiations using the following escalation procedure:

If the parties cannot resolve the Dispute within *** after the Dispute Notice is given (or longer period if the parties to the Dispute agree in writing), the parties must refer the Dispute to arbitration in accordance with clause 23.5.

Supply and license agreement – Mayne Pharma and HPPI | page 31

Confidential Treatment Requested by HedgePath Pharmaceuticals, Inc.,

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Confidential treatment requested with respect to certain portions hereof denoted with “***”

If the parties cannot resolve the Dispute under clause 23.4, the Dispute must be settled by arbitration in accordance with the UNCITRAL Arbitration Rules as at present in force and as may be amended by the rest of this clause. The appointing authority will be Atlanta International Arbitration Society. The place of arbitration will be Atlanta, Georgia. There will only be one arbitrator.

No party is prevented from applying to a court at any stage for urgent injunctive or other interlocutory relief.

GST

Any consideration to be paid or provided to the Supplier for a supply made by it under or in connection with this Agreement, unless specifically described in this Agreement as ‘GST inclusive’, does not include an amount on account of GST.

Supply and license agreement – Mayne Pharma and HPPI | page 32

Confidential Treatment Requested by HedgePath Pharmaceuticals, Inc.,

IRS Employer Identification No. 30-0793665

Confidential treatment requested with respect to certain portions hereof denoted with “***”

If a payment to a party under this Agreement is a reimbursement or indemnification or otherwise calculated by reference to a loss, cost or expense incurred by that party, then the payment will be reduced by the amount of any input tax credit to which that party, or the representative member of the GST group that party is a member of (as the case may be), is entitled in respect of that loss, cost or expense.

The Supplier will give the Recipient a tax invoice in respect of a taxable supply made under or in connection with this Agreement.

If and to the event an adjustment event arises in respect of a supply made under or in connection with this Agreement, then:

Clauses 24.2, 24.3 and 24.5 to 24.7 apply with the necessary changes in respect of any similar goods and services taxes or value added taxes levied in jurisdictions outside Australia.

Tax

Supply and license agreement – Mayne Pharma and HPPI | page 33

Confidential Treatment Requested by HedgePath Pharmaceuticals, Inc.,

IRS Employer Identification No. 30-0793665

Confidential treatment requested with respect to certain portions hereof denoted with “***”

Mayne Pharma has no obligation to file or otherwise pursue any refund of Taxes withheld or deducted from funds paid to Mayne Pharma.

Miscellaneous

Any indemnity or any obligation of confidence under this agreement is independent and survives termination of this agreement. Any other term by its nature intended to survive termination of this agreement survives termination of this agreement, to avoid doubt, including clause 3.2(b)(i), 7.1, 7.4, 7.5, 12.2(d), 0, 0, 18.1, 18.7, 19.3 to 19.5, 20.6 to 20.8, 0, 0, 0, 26.1, 26.11 and 26.14 and Schedule 7.

Except where this agreement expressly provides otherwise, a party may, in its discretion, give conditionally or unconditionally or withhold any approval or consent under this agreement.

Without limiting clause 0, a public announcement by HPPI in connection with this agreement or any transaction contemplated by it must be approved in writing by Mayne Pharma before it is made, except if required by law or a regulatory body (including any relevant stock exchange), in which case HPPI must, to the extent practicable, first consult with and take into account the reasonable requirements of Mayne Pharma.

Each party may appoint contractors to perform its obligations under this agreement, except that HPPI must obtain the prior written consent of Mayne Pharma before appointing a contractor to perform a material part of the HPPI’s obligations under this agreement. The appointment of any contractor by a party does not relieve that party of any of its obligations under this agreement.

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Each party must pay its costs and expenses of negotiating, preparing and executing this agreement.

The relationship of principal and agent does not exist between the parties. Each party is an independent contractor and not an agent of HPPI. Neither party has any authority to act, execute any documents or warrant or represent on behalf of or otherwise bind the other party.

This agreement cannot be modified except in writing and signed by each party.

A party’s failure to exercise any right conferred on it under this agreement will not be deemed to be a waiver of that right, unless it is in writing signed by that party. A party’s waiver of any right under this agreement at any given time is not deemed to be a waiver for any other time.

This agreement, including its schedules, constitutes the entire agreement between the parties in connection with its subject matter and supersedes all previous or contemporaneous agreements, promises or understandings between the parties in connection with its subject matter.

Each party must do, at its own expense, everything reasonably necessary (including executing documents) to give full effect to this agreement and any transaction contemplated by it.

If any term or provision of this agreement is held to be invalid or unenforceable, it is to be read down so as to be valid or enforceable or, if such reading down is not possible, severed and the remaining terms hereof will not be affected but will be valid and enforced to the fullest extent permitted by law.

This agreement may be executed in counterparts, including electronic counterparts. All executed counterparts constitute one document. Delivery of an executed signature page of this agreement by facsimile transmission or electronic transmission shall be as effective as delivery of a manually executed counterpart hereof.

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

[Schedules Follow Beginning on Next Page]

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Schedule 1 – Agreement details

3 September 2013

Starts on the Start Date and continues until the later of:

United States of America, including all of its commonwealths, territories and possessions.

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Schedule 2 – Conditions

After the Condition in item 1.2 of this Schedule 2 is satisfied, Mayne Pharma or its nominee shall enter into a stock purchase agreement reasonably acceptable to the parties under which HPPI shall issue to Mayne Pharma 170,000.74 shares of Series A Preferred Stock, representing, on an as fully converted, fully diluted basis, 45% of the issued and outstanding shares of capital stock of HPPI, before any dilution which may have occurred as a result of, and in accordance with, item 1.2 of this Schedule 2, or which may result because of shares reserved pursuant the EIP as set out in Schedule 8. Mayne Pharma will receive and hold its equity pursuant to representations, warranties, covenants and agreements that are commercially standard on such matters, including a confirmation of the capitalization table set out in item 3 of this Schedule 2.

HPPI obtains at least USD5 million by way of an equity raising, or such lesser amount as agreed by the parties in writing, provided that after such raising Mayne Pharma maintains a holding of at least 30% of the issued and outstanding shares of capital stock on an as fully converted, fully diluted basis, after any dilution which may result because of the shares reserved pursuant to the EIP as set out in Schedule 8. The equity raising can only be effected via the issuance of shares of common stock that rank junior to or pari passu with the Series A Preferred Stock held by Mayne Pharma or its nominee.

Hedgepath, LLC, Nicholas J. Virca and Mayne Pharma enter into an agreement that:

from holding, each in aggregate, more than 49% of the issued and outstanding shares of capital stock in HPPI on a fully converted, fully diluted basis (other than dilution as a result of the exercise of any option or other equity incentive award that is the subject of the restriction in item 1.3(c) of this Schedule 2 for so long as Nicholas J. Virca complies with that restriction);

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(as applicable) intend to enter into a transaction under which such entities would hold, each in aggregate, more than 49% of the issued and outstanding shares of capital stock in HPPI on a fully diluted basis;

Hedgepath, LLC must not have transferred any of its shares of capital stock in HPPI, and Nicholas J. Virca must not have exercised or transferred of any option under the EIP, from the Start Date until the agreement referred to in this item of 1.3 of Schedule 2 has been signed.

Within *** from a request by Mayne Pharma which Mayne Pharma must make no later than *** after the Start Date, HPPI will appoint Scott Richards of Mayne Pharma, or another officer, director or senior employee of Mayne Pharma as nominated by Mayne Pharma, (Initial Mayne Pharma Representative) as a member of HPPI’s board of directors. If at any time the Initial Mayne Pharma Representative is unable or unwilling to serve (it being agreed that if the Initial Mayne Pharma Representative is not an officer, director or senior employee of Mayne Pharma, he or she shall be disqualified from serving on the HPPI board of directors), HPPI must procure that a person nominated by Mayne Pharma (who shall be another officer, director or senior employee of Mayne Pharma) is appointed to the board of directors of HPPI. The board of directors of HPPI shall initially be comprised of 3 persons: Frank E. O’Donnell, Jr., Nicholas J. Virca and Samuel P. Sears, Jr. Mayne Pharma’s right to appoint the foregoing person to the HPPI board of directors shall continue until the earlier to occur of: (i) the date that this agreement is terminated or (ii) the date the Mayne Pharma or its Affiliates own less than ten percent (10%) of the outstanding capital stock of HPPI.

The parties enter into an agreement which provides, after the Condition Date, that:

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subject to, in each case, the restriction referred to in item 1.3(a)(ii) of this Schedule 2;

Mayne Pharma’s rights as set out in item 1.5(b) to (d) shall continue until the earlier to occur of: (i) the date that this agreement is terminated or (ii) date the Mayne Pharma or its Affiliates own less than ten percent (10%) of the outstanding capital stock of HPPI. The agreement setting out the details of Mayne Pharma’s right of first refusal shall include provisions relating to the time frames around the exercise of such right as well as customary exclusions such as strategic issuances of equity to commercial partners and issuances under the EIP.

The following two criteria are satisfied:

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Where any Condition requires an agreement, that Condition is only satisfied where:

For each agreement referred to in item 1.7 of this Schedule 2 (where Mayne Pharma is not a party to the agreement), HPPI must keep Mayne Pharma informed of the content of that agreement during negotiations and will consult with Mayne Pharma on all key terms.

If:

then a party may give notice to the other party requesting referral of the issue to the Chief Executive Officers or equivalent of each party who must seek to resolve the failure to agree. If the parties are unable to agree on terms that are reasonably acceptable or that a Condition has been satisfied within *** after such referral, then the Condition is deemed not to have been satisfied unless one party can show that the other party acted in bad faith in connection with the satisfaction of that Condition.

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Schedule 3 – Development Plan

***

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Schedule 4 – Product and Product Specification

Product: SUBA-itraconazole ***mg hard capsules

Hard gelatin capsules, size *** body and cap printed “***” in *** 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.

Comprehensive product specifications will be agreed between the parties during the conduct of the activities in the Development Plan and will form part of Marketing Authorisation submission to the Relevant Regulatory Authority.

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Schedule 5 – Economic details

***

***

EXW (Incoterms 2010), Salisbury, South Australia, Australia.

***

Mayne Pharma will provide Product for the conduct of the activities in the Development Plan and any other activities relating to the research, development or registration activities relating to the Product approved by Mayne Pharma, *** set out in the table below:

In response to a request by HPPI following a recommendation by the JDC, Mayne Pharma will review and consider changes to the relevant part of the Field for which the Product is used and/or the maximum number of capsules free of charge for the purposes of this item 5.1 of this Schedule 5, and may change either or both, acting in its discretion by notice to HPPI.

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HPPI *** Mayne Pharma for:

at the Floor Price, and payable by HPPI within *** of the date of Mayne Pharma’s invoice, to be issued on or after shipment of the Product; and

In this Schedule 5:

Actual ASP means ***.

Floor Price means the floor price set out in the table above.

Forecast ASP means ***.

***

Price is calculated under item 5.6 of this Schedule 5.

Total Net Sales means ***

Transfer Price means ***.

Total Units Sold means ***.

At least *** before the start of each ***, the parties will use reasonable commercial efforts to agree on the forecasted Total Net Sales on a per Product basis and the forecasted Total Units Sold for that ***, which will be used to calculate the Forecast ASP.

The Transfer Price must be reviewed by the parties, and if necessary, revised at least *** before the start of each ***. The Transfer Price for the Product at the time of invoice is ***

The Price to be paid by HPPI for the Product in the Territory is:

***

HPPI must, and must ensure that its Affiliate and any Sub licensee must, promptly process any deduction from Total Net Sales and in any event, process such deductions no later than *** after they are allowed (in the case of discounts, bonuses, commissions and rebates), applied or the Products are rejected or returned.

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Within *** from the end of each month of each Quarter, HPPI must use reasonable commercial efforts to submit to Mayne Pharma an estimated reconciliation report in reasonable detail.

USD

National Bank of Australia Limited

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Schedule 6 – Qualification of Backup Manufacturer

***

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Schedule 7 – Licence of HPPI Licensed Rights

From the Start Date, HPPI grants to Mayne Pharma an exclusive, perpetual, irrevocable, royalty free licence to copy and exploit outside the Territory any Intellectual Property Right (including all Developed Intellectual Property Right subject to clause 18.5 of the agreement, but excluding rights in respect of trade and service marks and logos) that satisfies all of the following criteria:

(HPPI Licensed Rights) including the HP Patents and also including, in respect of Intellectual Property Rights not yet in existence at the Start Date but created before the earlier of the dates referred to in items 1.1(b)(i) and (ii) of this Schedule 7), by way of a grant of a licence of future Intellectual Property Rights, which takes effect from the date of creation of those rights.

HPPI must:

HPPI is free to grant to Mayne Pharma an exclusive, perpetual, irrevocable, royalty free licence to copy and exploit outside the Territory such Intellectual Property Rights. Promptly on becoming aware of any restriction on such right to grant such licence, HPPI must notify Mayne Pharma.

The licence under item 1.1 of this Schedule 7 may only be assigned or sub licensed in accordance with this agreement or otherwise with the prior written consent of HPPI.

Promptly in response to a request by Mayne Pharma at any time during the Term or a reasonable period after the termination or expiry of this agreement, HPPI must provide to Mayne Pharma a copy of any documents, data and other information embodying the HPPI Licensed Rights since the most recent request by Mayne Pharma under this item 2 of Schedule 7.

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Upon notice to HPPI, Mayne Pharma may grant a sub licence of the HPPI Licensed Rights to a third party without the prior written consent of HPPI under a written agreement that includes obligations on that third party that relate to use and disclosure of Intellectual Property Rights of HPPI and Confidential Information of HPPI at least equivalent to those imposed on Mayne Pharma under this agreement.

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Despite clause 26.5(b), Mayne Pharma may assign any of its rights or obligations under this Schedule 7 without the prior written consent of HPPI.

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Schedule 8 – EIP

The Equity Incentive Plan (EIP) will be implemented by HPPI, provided the plan has been approved unanimously by the new HPPI Board of Directors (including the representative of Mayne Pharma).

As at the Start Date, the proposed EIP will initially be comprised of 32,583,475 (subject to adjustments for stock splits approved by the HPPI board of directors, the Initial EIP Pool) shares of common stock of HPPI (ranking pari passu with the issued and outstanding common stock of HPPI) to be available in the form of incentive stock options, non-qualified stock options, restricted stock, restricted stock units, performance awards and other customary equity incentives.

Nicholas J. Virca will be awarded 21,722,317 options from the Initial EIP Pool, seventy-five percent (75%) of which (or 16,291,738 options) will vest immediately, and twenty-five percent (25%) of which (or 5,430,579 options) will vest in nearly equal quarterly instalments over 18 months from the grant date. The exercise price and exercise periods of such options shall be customary and reasonably acceptable to both parties.

HPPI represents and agrees that all awards that are included in the Initial EIP Pool (including those already awarded to Nicholas J. Virca) are subject to a restriction on exercise or transfer until the earlier of: (i) 3 years after the Start Date or (ii) acceptance of a new drug application (NDA) for the Product in the Field by the Relevant Regulatory Authority being obtained by HPPI, any Affiliate or Sub Licensee, which restriction may only be changed with the prior written approval of Mayne Pharma. It is acknowledged and agreed however that if the HPPI board of directors votes to approve an increase in the EIP beyond the size of the Initial EIP Pool, such additional shares of common stock and related awards beyond the Initial EIP Pool shall not be subject to the foregoing restrictions on exercise or transfer.

HPPI represents and agrees that Frank E. O’Donnell, Jr. M.D. will not be entitled to participate in the EIP for the first 12 months after the Start Date.

HPPI agrees that:

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Signing page

EXECUTED as an agreement.

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