Document:

fgen-ex105_96.htm

 

[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.

 

Exhibit 10.5

FIRST AMENDMENT TO
May 23, 1997 LICENSE AGREEMENT

The First Amendment to the May 23, 1997 License Agreement (the “1997 License Agreement”) by and between University of Miami (the “University”) and FibroGen, Inc., and its Affiliates (the “Company”)(collectively, the “Parties”) is effective July 29, 1999. Except as otherwise set forth herein, the defined terms in the 1997 License Agreement shall be incorporated by reference herein.

The Parties hereby agree to amend the 1997 License Agreement as follows:

1.Section 1.4 shall be amended and restated in its entirety to read as follows: “Patent Rights” shall mean the University’s share of (a) United States Patent No.

[ * ], United States Patent Application Serial Number [ * ], and the two United States Patent Applications filed on [ * ] entitled [ * ] for which numbers have not yet been assigned, (b) any applications filed prior to this date relating to CTGF, homologs to CTGF, [ * ] and/or methods of use or treatment thereof which University’s employees are joint or sole inventors thereon or any applications filed hereafter for which the Company has provided research funding pursuant to the November 29, 1995 Research Agreement between the Parties, as amended, or any subsequent funding arrangement between the Parties, (c) and the United States and foreign patents issuing from said United States and foreign patent applications collectively, hereinafter referred to as the “Patent Rights Patent Application”) or later filed domestic or foreign applications based on the said United States Patents and applications (hereinafter referred to as the “Patent Rights Patents”) and any continuations, continuations-in-part, divisions, reissues or extensions of any of the foregoing. In the event that the University has or acquires any rights to United States Patent Nos. [ * ]; or United States Patent Application Serial Number [ * ], and foreign application (including PCT No. [ * ]), continuations, continuations-in-part, divisions, reissues or extensions thereof, such rights shall be included in “Patent Rights”, “Patent Rights Patent Application” or “Patent Rights Patents” as appropriate.

2.Section 4.1 (b) shall be amended and restated in its entirety to read as follows:

(b)(i) Subject to clause (ii) below, Company shall pay University a running royalty equal to:

(x)[ * ] of Net Sales of any Licensed Products and/or the sale of product labeled for a Licensed Method use (a “Royalty Product”) in cases other than specified in (y) or (z),

 

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(y)[ * ] of Net Sales of any Royalty Product in the case that such Royalty Product is also covered by a patent or patent application owned or held by the University of South Florida .

(z)[ * ] of Net Sales of any Royalty Product in the case that any of the Patent Rights covering such Royalty Product is jointly owned or held by the Company.

(ii) The applicable running royalty set forth in Section 4.2.(b)(i) may be reduced by any royalty obligations of the Company to other third parties (except the University of South Florida) on the sale of Royalty Products; provided, however that the University’s royalties shall not be offset by more than seventy-five percent (75%) (i.e. so that the royalty rate may be reduced to [ * ] in (b)(i)(x) or [ * ] in (b)(i)((y) and (z)). In the event that the Company reduces the royalty to the University pursuant to the foregoing, the Company must disclose to the University the third party royalty payment and the identity of such third party.

3.Section 4.1(c) shall be amended and restated in its entirety to read as follows:

The Company shall pay the University milestone payments on the first Royalty Product to reach the following milestone in the first major country (United States, Japan, U.K., France, Italy, Spain or Germany):

 

				
	
Upon acceptance of an IND with the FDA or
commencement of any human clinical trial
	
 
	
$
	
50,000

	
Upon successful completion of Phase II in the U.S. (or
comparable foreign clinical trial)
	
 
	
$
	
100,000

	
Upon written notice of FDA (or comparable foreign body)
approval for marketing
	
 
	
$
	
[ * ]

 

In no event shall the foregoing be construed to require the Company to pay any of the above milestones the University more than once.

In addition, the Company shall pay the University $[ * ] for any subsequent approval by the first of the FDA or comparable foreign body in a major country for an additional indication for such previously approved Royalty Product or additional Royalty Product (but not the same indication or same Royalty Product in additional markets or countries).

Payment to the University by the Company shall be made within [ * ] days of the achievement of the applicable milestone.

4.Section 4.4 shall be deleted.

 

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[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.

 

5.With respect to the United States Patent Application No. [ * ] filed in [ * ] and any divisionals, continuations or continuations in part thereof or foreign counterparts filed relating to the foregoing, the Company shall pay no more than a [ * ] royalty in total to the University and/or University of South Florida on sales of Royalty Products and to the extent that questions of inventorship arise as to whether the patent covers such Royalty Product or whether the University should be included as an assignee to such patent, such issue shall be resolved by mutually agreed upon third party patent attorney. The royalty shall be allocated based upon the proportion of patents held by each institution or such other reasonable method of allocation agreed to by the Parties in good faith. For example, assuming that no other offsets apply, if University has 1 solely-held patent, University of South Florida has 3  solely-held patents and they jointly- hold 1 patent, then University of South Florida would be entitled to 70% (3.5/5) and the University would be entitled to 30% (1.5/5) of the [ * ] royalty. Accordingly, the University of South Florida would receive a [ * ] royalty and the University would receive a [ * ] royalty.   This Section 5 would not be effective unless University of South Florida agrees to a comparable provision.

6.Section 6.1 is amended to add the following sentence:

The University agrees that the Company shall control the prosecution and maintenance of the United States Patent Applications filed on [ * ] entitled [ * ] and any other Patent Rights Patents.

Except as set forth above, the 1997 License Agreement shall remain in full force and effect in accordance with all other terms and conditions specified therein.

IN WITNESS WHEREOF, the parties have executed this Amendment as of the date set forth below.

 

	
UNIVERSITY OF MIAMI
	
 
	
 
	
 
	
 

	
 
	
 
	
 
	
 
	
 

	
/s/Alan Fish
	
 
	
Date:
	
 
	
8/5/99

	
 
	
 
	
 
	
 
	
 

	
FIBROGEN, INC.
	
 
	
 
	
 
	
 

	
 
	
 
	
 
	
 
	
 

	
/s/Thomas B. Neff
	
 
	
Date:
	
 
	
8/3/99

	
Thomas B. Neff
	
 
	
 
	
 
	
 

	
Chief Executive Officer
	
 
	
 
	
 
	
 

 

153205147 v1 

[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.fgen-ex106_95.htm

[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.

 

 

Exhibit 10.6

AMENDMENT NO. 2

TO

RESEARCH AND COMMERCIALIZATION AGREEMENT

This Amendment No. 2 to research and commercialization Agreement ("Amendment") is made and entered into effective as of January 28, 2002 (the "Amendment Date") by and between Medarex, Inc., 707 State Road, Suite 206, Princeton, NJ 08540, GenPharm International Inc., a wholly-owned subsidiary of Medarex, Inc. (together, "Medarex"), and FibroGen, Inc., a Delaware corporation, 225 Gateway Boulevard, South San Francisco, California 94080 and FibroPharma, Inc., a wholly-owned subsidiary of FibroGen, Inc. (collectively, "FibroGen"). Capitalized terms used in this Amendment that are not otherwise defined herein shall have the same meanings as such terms are defined in the Agreement (as defined below).

WHEREAS, Medarex and FibroGen entered into a Research and Commercialization Agreement dated as of July 9, 1998 (the "Agreement"), as amended as of June 30, 2001, under which FibroGen acquired a research license and an option to acquire commercial licenses under the Medarex Technology.

WHEREAS, the parties desire to amend the Agreement to extend the term of the Research Period under the Agreement and to clarify the scope of the licenses granted under the Agreement.                                                                                                         '

Now, THEREFORE, the parties agree as follows:

	
1.
	
Amendment of the Agreement.

The parties hereby agree to amend the terms of the Agreement as of the Amendment Date as provided below.

	
 
	
1.1
	
Amendment of Section 2.6.2.  Section 2.6.2 of the Agreement is hereby amended to read in its entirety as follows:

"2.6.2 With notice to Medarex at least thirty (30) days prior to the first anniversary of the Effective Date, FibroGen may extend the term of the Research Period until the second anniversary of the Effective Date and, with notice to Medarex at least thirty (30) days prior to the second anniversary of the Effective Date, FibroGen may extend the term of the Research Period until the third anniversary of the Effective Date and, with notice to Medarex at least thirty (30) days prior to the third anniversary of the Effective Date, FibroGen may extend the term of the Research Period until February 28, 2002 and, with notice to Medarex at least thirty (30) days prior to February 28, 2002, FibroGen may extend the term of the Research Period until March 31, 2002, and in each case, FibroGen shall continue to make quarterly research support payments (or, if research services are provided by Medarex for less than a full calendar quarter, a research support payment equivalent to a pro rata portion of such quarterly research support payment as applicable) as provided in Section 2.2.  If

 

 

FibroGen (i) extends the Research Period for at least six (6) months (so that the Research Period is at least eighteen (18) months and Medarex has received at least five hundred seventy thousand dollars ($570,000) of research support payments pursuant to Section 2.2), and (ii) exercises its option and acquires a commercial license pursuant to Section 3.1.2, then FibroGen shall be considered to have exclusivity of all the Antigens listed on Exhibit A in accordance with Section 2.6.5."

	
2.
	
Scope of Agreement.

	
 
	
2.1
	
Mice. For purposes of clarity, the parties acknowledge and agree that [ * ] and [ * ] (as such terms are defined below) are not included in the definition of Mice under the Agreement.

For purposes of this Amendment and the Agreement, "[ * ]" shall mean any mice comprising both (i) [ * ] developed by Medarex or otherwise developed through use of Medarex's proprietary HuMAb Mouse; and (ii) [ * ], including, without limitation, any mouse comprising the nucleic acids described in clause (i) and clause (ii) of this Section that is derived by (X) [ * ] HuMAb Mouse [ * ], (Y) introducing nucleic acids obtained, isolated, or derived from a HuMAb Mouse [ * ], or (Z) introducing nucleic acids obtained, isolated, or derived from a [ * ] into one or more cells obtained from a HuMAb Mouse.

For purposes of this Amendment and the Agreement, "[ * ]" shall mean any immunizable [ * ] mouse developed by [ * ] that contains [ * ] thereof that include [ * ] that provide for [ * ], and which [ * ] comprises an [ * ].

	
3.
	
Miscellaneous.

	
 
	
3.1
	
No Other Changes. Except as expressly provided in this Amendment, all terms of the Agreement shall remain in full force and effect.

	
 
	
3.2
	
Counterparts. This Amendment may be executed in two or more counterparts, each of which shall be deemed an original, but both of which together shall constitute one and the same instrument.

 

 

 

 

[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.

 

IN WITNESS WHEREOF, the parties have caused this Amendment to be executed by their respective authorized officers.

 

	
Medarex, Inc.
	
 
	
FibroGen, Inc.

	
 
	
 
	
 
	
 
	
 
	
 
	
 

	
By:
	
 
	
/s/Jim Cornett
	
 
	
By:
	
 
	
/s/ Jack Anthony

	
Name:
	
 
	
Jim Cornett
	
 
	
Name:
	
 
	
Jack Anthony

	
Title:
	
 
	
VP Business Development
	
 
	
Title:
	
 
	
VP Business Development

	
Date:
	
 
	
16 July 2001
	
 
	
Date:
	
 
	
6/28/01

	
 
	
 
	
 

	
GenPharm International, Inc.
	
 
	
FibroPharma, Inc.

	
 
	
 
	
 
	
 
	
 
	
 
	
 

	
By:
	
 
	
/s/ Jim Cornett
	
 
	
By:
	
 
	
/s/ Jack Anthony

	
Name:
	
 
	
Jim Cornett
	
 
	
Name:
	
 
	
Jack Anthony

	
Title:
	
 
	
VP Business Development
	
 
	
Title:
	
 
	
VP Business Development

	
Date:
	
 
	
16 July 2001
	
 
	
Date:
	
 
	
6/29/01

 

 

[ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted because it is both (i) not material and (ii) would likely cause competitive harm to the company if publicly disclosed.

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