Document:

Letter Agreement between Asphelia Pharmaceuticals and OvaMed GmbH

 Exhibit 10.13 
 CONFIDENTIAL TREATMENT REQUESTED. 
 INFORMATION FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN 
 REQUESTED IS OMITTED AND MARKED WITH “[*******]” OR OTHERWISE 

CLEARLY INDICATED. AN UNREDACTED VERSION OF THIS DOCUMENT HAS 

ALSO BEEN PROVIDED TO THE SECURITIES AND EXCHANGE COMMISSION. 
 Ovamed GmbH • Kiebitzhörn 33-35 • 22885 Barsbüttel • Germany 
 Xavier Frapaise 
 MD President and CEO 
 Asphelia Pharmaceutics, Inc. 
 4365 Executive Drive, Suite 1500 

San Diego, California 92121 
 USA 

November 8, 2007 
 Ref:
    Exclusive Sublicense Agreement and Manufacturing & Supply Agreement 
 Further to our recent
communications, the purpose of this letter is to confirm our mutual understanding regarding the resolution of all matters relating to the above-mentioned agreements. 
  

	 	1.	Ovamed GmbH (“Ovamed”) and Collingwood Pharmaceuticals, Inc. (“Collingwood”) entered into an Exclusive Sublicense Agreement having an effective date
of December 12, 2005 (the “Sublicense Agreement”). On April 27, 2007, Collingwood assigned the Sublicense Agreement to its affiliate Asphelia Pharmaceuticals, Inc. (“Asphelia”). All references to
“Collingwood” in the Sublicense Agreement shall be replaced with “Asphelia”. 

  

	 	2.	Asphelia and Ovamed agreed upon the final terms of a Manufacturing and Supply Agreement (the “M&S Agreement”), the latest version of which is dated
March 29, 2006. Upon execution of this letter agreement, the parties shall modify the M&S Agreement to reflect that Ovamed possesses the exclusive right to manufacture and supply TSO (the “Product”) for non-clinical, clinical and
commercial use consistent with the terms of the M&S Agreement and the Sublicense Agreement, as revised. The parties shall further modify the M&S Agreement to reflect Ovamed’s obligation to build and bring on-line another GMP production
facility in the US prior to commencement of Phase 3 studies for the Product in the US. The launch of such US production facility shall be contingent upon Asphelia’s provision to Ovamed of an annual forecast and purchase order(s) (in accordance
with the M&S Agreement) reflecting Asphelia’s intent to purchase a minimum of [*******] unit doses of Product (at the price stipulated in the M&S Agreement) to be used in connection with Phase 3 studies. The M&S Agreement shall
further obligate Ovamed to share its know-how, patents and other related intellectual property with a third-party manufacturer in the event that Ovamed is unable to meet Asphelia’s non-clinical, clinical or commercial supply requirements for
the Product. Subject to inclusion in the M&S Agreement of the terms described in this Paragraph 2, the parties shall immediately execute the M&S Agreement. In the event of any discrepancy between the terms of the M&S Agreement and this
letter, the terms of this letter shall govern in all material respects. 

  
 Page 1 of 3

	 	3.	Set forth on Exhibit 1 attached hereto is a summary of costs incurred by Ovamed as of the date of this letter relating to the preparation, filing, prosecution and
maintenance of the Patent Rights (as that term is defined in the Sublicense Agreement). Within ten (10) days following the execution date of this letter agreement, Asphelia shall pay to Ovamed the balance of [*******] Dollars and [*******]
Cents ($[*******]) for such costs outstanding as of the date of this letter. Asphelia shall continue to reimburse Ovamed for costs relating to the preparation, prosecution and maintenance of the Patent Rights as provided for the Sublicense
Agreement, and the parties shall collaborate in good faith regarding the preservation and expansion of patent and other intellectual property protection relating to the Products. Ovamed and Asphelia shall discuss the further payment of costs
incurred by Ovamed relating to the Patent Rights in Europe outside of the Field (as that term is defined in the Sublicense Agreement) considering the effective use of these rights. 

 

	 	4.	Regarding Section 4.3.1 of the Sublicense Agreement, Asphelia agrees to the following with respect to prepayment of the One Million Five Hundred Thousand Dollars
($1,500,000) milestone payment that otherwise is due upon IND filing: 

  

	 	a.	Five Hundred Thousand Dollars ($500,000) within forty-five (45) days of the execution date of this letter as a 1st prepayment; 

 

	 	b.	A 2nd prepayment of Five Hundred Thousand Dollars ($500,000) until the end of May 2008 shall be considered; and 

 

	 	c.	A 3rd prepayment of Five Hundred Thousand Dollars ($500,000) until the end of December 2008 shall be considered. 

The payment of One Million Five Hundred Thousand Dollars ($1,500,000) (as outlined in Section 4.3.2 of the Sublicense Agreement)
shall remain due and owing on the [*******], currently expected to occur in the [*******]. 
  

	 	5.	Ovamed agrees to conduct an FDA-like audit immediately upon Asphelia’s payment of the amount described in Paragraph 4(a). Such audit shall occur at Parasite
Technologies and Ovamed shall furnish to Asphelia copies of the related audit report, along with any other information relevant to such audit. 

  

	 	6.	Asphelia agrees to provide to Ovamed proposed timelines for the clinical development of the Product within thirty (30) days of the execution of this letter.

  

	 	7.	Ovamed and Asphelia agree to approach [*******] with the intent to establish a mutual cooperation for regulatory approval of the Product, as well as related research
and development. 

  
 Page 2 of 3

	 	8.	The parties hereby agree to establish a Steering Committee (the “Committee”) to monitor the preclinical and clinical development and regulatory
approval of the Product in the Field and Territory (as those terms are defined in the Sublicense Agreement). The Committee will consist of independent scientific and technical thought leaders that are highly regarded by the scientific community in
the field of the Products and at least one representative from each of Ovamed and Asphelia. Subject to Paragraph 7, the parties shall further endeavor to include in such Committee a representative from [*******]. The Committee will meet at least
twice per year (unless unanimously agreed to otherwise by the Committee). 

  

	 	9.	Subject to each party’s compliance with the terms described in this letter, the parties acknowledge and agree that the Sublicense Agreement is in full force and
effect in accordance with its terms. Notwithstanding any prior communications between the parties, upon the execution of this letter and each party’s compliance with its terms, there exist no breaches, defaults or events which would (with the
giving of notice, the passage of time or both) give rise to a breach, default or other right to terminate or modify the Sublicense Agreement. 

 Agreed and acknowledged 
  

					
	Date: November 8, 2007	 		 	Date: November 8, 2007
			
	 /s/ Detlev Goj
	 		 	 /s/ Xavier Frapaise, MD

	 Detlev Goj, CEO
 Ovamed
GmbH
	 		 	 Xavier Frapaise, MD, President & CEO
 Asphelia Pharmaceuticals, Inc.

  
 Page 3 of 3Amendment No. 1 to License Agreement between UCL Business PLC

 Exhibit 10.14 
 CONFIDENTIAL TREATMENT REQUESTED. 
 INFORMATION FOR WHICH CONFIDENTIAL
TREATMENT HAS BEEN 
 REQUESTED IS OMITTED AND MARKED WITH “[*******]” OR OTHERWISE 

CLEARLY INDICATED. AN UNREDACTED VERSION OF THIS DOCUMENT HAS 

ALSO BEEN PROVIDED TO THE SECURITIES AND EXCHANGE COMMISSION. 

AMENDMENT No. 1 to LICENSE AGREEMENT 
 Amendment No. 1 made and effective as of September 30, 2009 to the License Agreement dated November 5, 2007 entered into by and between Coronado Biosciences, Inc., a Delaware corporation
having a place of business at 787 Seventh Avenue, 48th
Floor, New York, New York 10019 (“Company”) and UCL Business PLC whose registered office is The Network Building, 97 Tottenham Court Road, London W1T 4TP United Kingdom (“UCLB”): 

WITNESSETH: 
 Whereas, Company and UCLB executed a License Agreement dated November 5, 2007 (“License Agreement”) pursuant to which Company is developing TANKs; 

WHEREAS, University College London (“UCL”) has collected, generated or owns the Clinical Data; 

WHEREAS, UCL has assigned to UCLB all of its right, title and interest in and to such Clinical Data; 

WHEREAS, Company wishes to license the Clinical Data for a specified use only; 

WHEREAS, UCLB is willing to provide a copy of the Clinical Data to the Company; 

WHEREAS, the parties now desire to amend the License Agreement in certain respects on the terms and conditions set forth below.

 NOW THEREFORE, in consideration of the foregoing premises and the mutual covenants set forth below, the parties amend the
Agreement and otherwise agree as follows: 
  

	1.	Unless otherwise set forth in this Amendment No. 1, each capitalized term and abbreviation has the meaning set forth in the License Agreement.

	2.	Amendments 

 A. In Article 1 of the
License Agreement, the following terms and their related definitions are inserted immediately following the term “Valid Claim” and its definition: 
 Clinical Data: Means (a) the original data described in Schedule Three; (b) any and all materials, documents and information that UCLB may provide to the Company under or in connection with this
Agreement; (c) any derivative, modified or improved dataset obtained from or as a result of the use of the whole or any part of the foregoing. 
 Clinical Data Field: Means the use of Clinical Data for purposes of securing Regulatory IND filing (in the United States of America, or equivalent filings in other countries) in the Territory and Field.

 Employees: Employees, contractors or advisors of the Company who have contractual obligations to the Company that enables the Company to
comply with its obligations under this Agreement with respect to such individuals. 
 Third Party: Any person other than the Parties, Company
and the Employees. 
 B. At the conclusion of the License Agreement, immediately following the current Schedule 2, the attached document
(entitled “Schedule Three”) is inserted therein. 
 C. In Article 2 of the License Agreement, immediately following Section 2.6,
new Section 2.7 is inserted therein as follows: 
 Section 2.7 UCLB hereby grants, and Company accepts, a non-exclusive license to
UCLB’s rights in the Clinical Data in the Clinical Data Field for use in the Field and Territory. Said license does not include the right to grant sublicense(s). Company shall keep the Clinical Data secure at the Company’s principle place
of business and shall ensure that: (a) It provides suitable administrative, technical and physical safeguards to ensure the confidentiality of the Clinical Data and to prevent unauthorized use and access of the Clinical Data; (b) It
operates suitable systems for tracking the Clinical Data; and (c) No one other than the Employees shall have access to the Clinical Data. Notwithstanding anything to the contrary herein Company: (a) shall not merge or incorporate the
Clinical Data with any other data set or information, nor change the format of the Clinical Data, without the prior written consent of UCLB, except as reasonably required by applicable regulatory agencies such as the FDA, EMEA and MHLW;
(b) shall not sell, gift, transfer, assign, rent, lease or otherwise supply or disclose the Clinical Data to any Third Party; (c) shall not sell a product or tradable 

 
commodity that comprises any portion of the Clinical Data supplied unless prior written permission is obtained in writing from UCLB; (d) shall provide UCLB with written notification of the
number of copies of the Clinical Data to be made and the location where each copy will be stored; (e) shall perform its activities using the Clinical Data in accordance with all applicable laws, regulations and ethical approvals and shall
ensure that it has all necessary ethical and legal permissions in place to perform its activities under this Agreement prior to commencing any activity requiring such permission. Except as expressly provided by this Agreement, no license to the
copyright or any other intellectual property rights in the Clinical Data, services, documents, or any software tools, design concepts, know-how, techniques or methodologies supplied by UCLB is granted or implied by this Agreement. UCLB shall retain
title to all Clinical Data. 
 D. In Article 4 of the License Agreement, immediately following Section 4.1(b), new Section 4.1(c) is
inserted therein as follows: 
 Section 4.1(c) Within thirty (30) days following the effective date of this Amendment, Company shall
pay to UCLB the following, non-creditable, non-refundable license issue fees in respect of Clinical Data: £1000. All payments to UCLB made pursuant to this Section 4.1(c) shall be in pounds sterling and all such payments shall be
exclusive of VAT which, where applicable, shall be payable in addition to the sum stated and at the prevailing rate. Upon receipt of payment of the fees stated in Clause 3.1, UCLB shall send the Clinical Data to Company in such form and by such
methods as the parties may agree. All payments shall be made by the due date, failing which UCLB may charge interest on any outstanding amount on a daily basis at a rate of [*******]%. 

 

	3.	Representations and Warranties. 

  

	 	(a)	Each party hereby represents and warrants to the other party as follows: 

  

	 	(i)	This Amendment has been duly executed and delivered on behalf of such party, and constitutes a legal, valid, binding obligation, enforceable against such party in
accordance with its terms. 

  

	 	(ii)	All necessary consents, approvals and authorizations of all governmental authorities and other entities required to be obtained by such party in connection with this
Amendment have been obtained. 

  

	 	(b)	UCLB hereby represents and warrants to Company as follows: 

  

	 	(i)	The License Agreement is in full force and effect in accordance with its terms. After giving effect to this Amendment, there exist no breaches, defaults or events which
would (with the giving of notice, the passage of time or both) give rise to a breach, default or other right to terminate or modify the License Agreement. 

	4.	Except as expressly modified by this Amendment No.1, all of the terms and conditions of the License Agreement shall continue in effect. 

IN WITNESS WHEREOF, Company and UCLB, intending to he bound, have executed this Amendment No. 1 by their duly authorized representatives, and this
Amendment No. 1 shall be part of the License Agreement between the parties as of the date first written above. This Amendment may be executed in counterparts, each of which shall be deemed to be an original and together shall be deemed to be
one and the same agreement. 
  

									
	For and on behalf of UCLB	 		 	For and on behalf of the Coronado Biosciences, Inc.
					
	Signed:	 	 /s/ Anne Lane
	 		 	Signed:	 	 /s/ Raymond J. Tesi

			
	Print name: Anne Lane, M.D.	 		 	Print name: Raymond J. Tesi, M.D.
			
	Title: Executive Director	 		 	Title: President and CEO
			
	Date: 6/10/09	 		 	Date: 10/6/09

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00192-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00192-of-00352.parquet"}]]