Amendment No. 2 to Supply and License Agreement



 Exhibit 10.1 

March 6, 2014 
 Mr. Nick Virca 

President and CEO, HedgePath Pharmaceuticals, Inc. 

nvirca@hedgepathpharma.com 
 Dear Nick: 

Amendment No. 2 to Supply and License Agreement 
 We refer
to the supply and license agreement dated, September 3, 2013, between Mayne Pharma International Pty Ltd and HedgePath Pharmaceuticals, Inc., as amended (Agreement). For due and valuable consideration, the receipt and sufficiency of
which each party acknowledges, and in accordance with clause 26.8 of the Agreement, the parties agree to amend the Agreement, as set out below. 

AMENDMENT 
  

	 	1.	Commencement of this amendment 

 This amendment (Amendment No. 2)
takes effect from the date the same is mutually executed by the parties (Date of Amendment No. 2), and is supplementary to and shall be read in conjunction with the Agreement. In the case of any inconsistency between the terms and
provisions of the Agreement and the terms and provisions of this Amendment No. 1, the terms of this Amendment No. 2 shall govern. 
  

	 	2.	Definitions and interpretation 

  

	 	a.	Except to the extent expressly provided otherwise in this Amendment No. 2, terms and expressions defined in the Agreement have the same meaning in this Amendment No. 2, and references to clauses are
references to clauses in the Agreement.  

  

	 	b.	The parties agree to extend the Condition Date to 31 March 2014, as that date may be further extended: 

  

	 	i.	by agreement of the parties in writing; or 

  

	 	ii.	by Mayne Pharma in its discretion by notice to HPPI if the Conditions have not been satisfied by the then current Condition Date. 

  

	 	3.	Initial contribution by Mayne Pharma to third party development expenses 

 The parties
acknowledge that HPPI has not yet sought reimbursement of any third party expenses under section 3 of Amendment No 1. HPPI agrees to use reasonable efforts to progress the conduct of the activities set out in, and in accordance with, the Development
Plan, promptly after the Date of Amendment No.2 and to seek reimbursement of relevant amounts from Mayne Pharma in accordance with section 3 of Amendment No 1 and subject to sections 4 and 5 of Amendment No 1. 

 
 



 








 



 
  


	 	4.	Equity raising 

 Mayne Pharma acknowledges that warrants may be issued in connection with
the equity raising in item 1.2 of Schedule 2, provided that: 
  

	 	a.	Mayne Pharma is issued warrants on equivalent terms; and 

  

	 	b.	if Mayne Pharma elects to exercise such warrants, Mayne Pharma is able to maintain a holding of at least 30% of the issued and outstanding shares of capital stock on an as fully converted, fully diluted basis following
the equity raising in item 1.2 of Schedule 2 (including as a result of any dilution which may result because of the stock reserved pursuant to any other issued warrants and the EIP as set out in Schedule 8). 


 

	 	5.	Agreements on Transfers and Holding of Equity 

 The parties agree to amend Condition in
item 1.3 of Schedule 2 of the Agreement so that, in addition to what is already contemplated: 
  

	 	a.	Frank E. O’Donnell is also a party to the required agreement; 

  

	 	b.	if Frank E. O’Donnell or Jr or Nicholas J. Virca proposed to divest of any rights in HPPI (including by sale of any capital stock, options or warrants), Mayne Pharma will have a first right of refusal to acquire
such rights; and 

  

	 	c.	if HPPI does not: 

  

	 	i.	submit a complete Investigational New Drug (IND) application to the FDA for the Product for at least one indication in the Field and commence dosing patients in at least two phase II or phase II/III clinical trials
across at least two indications in the Field by March 31, 2015; or 

  

	 	ii.	submit an application for a new NDA to the FDA for at least one indication by March 31, 2016, 


then Mayne Pharma may, by notice with immediate effect, require the resignation of each or both of Frank E. O’Donnell, Jr and Nicholas J.
Virca from HPPI’s board of directors, in which case: 
  

	 	iii.	each of Hedgepath LLC, Frank E. O’Donnell, Jnr or Nicholas J. Virca forfeit all unvested warrants and options in HPPI; and 

  

	 	iv.	Mayne Pharma has the option to acquire from any of Frank E. O’Donnell, Jnr or Nicholas J. Virca all of his capital stock in HPPI at the open market price at that time; and 


  
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	 	v.	no severance or other ex gratia payments shall be due to Frank E. O’Donnell, Jnr or Nicholas J. Virca. 

  

	 	6.	Board positions 

 Any replacement to Frank E. O’Donnell, Jnr or Nicholas J. Virca to
the board of HPPI must be appointed with the unanimous approval of all remaining board members. 
  

	 	7.	Development program 

 Mayne Pharma waives its right to require satisfaction of the
Condition referred to in item 1.6 of Schedule 2. 
  

	 	8.	Stamp duty 

 HPPI shall be responsible for and pay any stamp duty assessed or charged in
respect of this Amendment No. 2. 
  

	 	9.	Confirmation of the Agreement 

 Subject only to this Amendment No. 2, the parties
confirm the terms and conditions of the Agreement in all other respects. 
  

	 	10.	Representations of the parties 

 Each party represents and warrants, with effect the Date
of Amendment No. 2, that: 
  

	 	a.	it is a corporation organised and validly existing under the laws of its jurisdiction of incorporation and has the legal capacity and authority to enter the Agreement (as amended) and perform its obligations
under the Agreement (as amended); and 

  

	 	b.	this Agreement (as amended) is a valid and binding obligation of that party enforceable in accordance with its terms, and it will not become a party to any agreement in conflict with this Agreement (as amended).


  

	 	11.	Counterparts 

 This Amendment No. 2 may be executed in counterparts, including
electronic counterparts. All executed counterparts constitute one document. Delivery of an executed signature page of this Amendment No. 2 by facsimile transmission or electronic transmission shall be as effective as delivery of a manually
executed counterpart hereof. 

  
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 Please indicate your agreement with the above by countersigning this Amendment No. 2 below. 

Sincerely 
 /s/ Scott Richards 

Scott Richards 
 CEO, Mayne Pharma International Pty Ltd 

scott.richards@maynepharma.com 
 Date: March 6, 2014 

 

	
	 Accepted and agreed by
  

HedgePath Pharmaceuticals, Inc.

	
	 /s/ Nicholas J. Virca

Nicholas J. Virca
 President and CEO

	
	Date:                     


 [Signature Page to Amendment No. 2 to Supply and License Agreement] 

  
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