AMENDMENT NO.19 TO THE PROCESS DEVELOPMENT AND CLINICAL SUPPLY AGREEMENT
[*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Act of 1934, as amended.
Exhibit 10.28(xxi)
AMENDMENT NO.19 TO THE PROCESS DEVELOPMENT AND CLINICAL SUPPLY AGREEMENT
THIS AMENDMENT No. 19 (the “Nineteenth Amendment”), effective as of March 01, 2015 (the “Nineteenth Amendment Effective Date”) by and between Boehringer Ingelheim Biopharmaceuticals GmbH, Binger Str. 173, 55216 Ingelheim, Germany (“BI”) and FibroGen, Inc., 409 Illinois Street, San Francisco, CA 94158, USA (“FibroGen”), amends the Process Development and Clinical Supply Agreement entered into by and between Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Str. 65, 88397 Biberach an der Riss, Germany (“BI Pharma”) and FibroGen on November 29, 2007, as amended pursuant to the letter agreements entered into as of June 26, 2008 and August 18, 2008, Amendment No. 1, effective as of May 28, 2009, Amendment No. 3, effective as of November 05, 2010, Amendment No. 4, effective as of January 24, 2011, Amendment No. 5, effective as of April 15, 2011, Amendment No. 6, effective as of May 26, 2011, Amendment No. 7, effective as of January 01, 2012, Amendment No. 8, effective as of July 10, 2012, Amendment No. 9, effective as of November 26, 2012, Amendment No. 10, effective as of June 21, 2013, Amendment No. 11, effective as of July 9, 2013, Amendment No. 12, effective as of August 01, 2013 and subsequently assigned by BI Pharma to BI, Amendment No. 13, effective as of March 06, 2014, Amendment No. 14, effective as of February 05, 2014, Amendment No. 15, effective as of October 20, 2014, Amendment No. 16, effective as of December 08, 2014, Amendment No. 17, effective as of December 08, 2014, and Amendment No. 18, effective as of February 15, 2015 (hereinafter together the “Supply Agreement”). BI and FibroGen shall be referred to individually herein as a “Party”, and collectively as the “Parties”.
WHEREAS, FibroGen wishes to engage BI Pharma to [*], which will be provided by FibroGen, in compliance with the terms of the Supply Agreement as set forth in and as amended by this Nineteenth Amendment. The activities hereunder will be performed by BI Pharma on behalf of BI.
NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties agree as follows:
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| (1) | Unless otherwise defined herein, all capitalized terms and phrases used in this Nineteenth Amendment shall have the meaning ascribed to them in the Supply Agreement. |
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| (2) | Pursuant to Section 2.2 of the Supply Agreement, the work plan entitled [*] (Work Scope, Version of March 16, 2015)”, attached hereto as Exhibit A, is hereby added as an amendment to Appendix 2 to the Supply Agreement. Pursuant thereto BI Pharma shall [*] provided by FibroGen on behalf of FibroGen in accordance with the Supply Agreement. |
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| (3) | The Deliverables related to the Work Scope as indicated in the attached Exhibit A hereto is for BI Pharma to [*] under Exhibit A hereto, provided by FibroGen, and, during the term of the Supply Agreement, to [*], as further described in the Work Scope (Exhibit A) [*], as needed and requested by FibroGen in the course of [*]. |
The total aggregate payment of [*] (as listed under Exhibit A hereto) will be paid by FibroGen to BI Pharma upon the [*]. Any questions regarding the [*] listed under Exhibit A hereto, which may arise from [*] will be answered by BI Pharma, as needed and requested by FibroGen in the course of [*] and the continuation of the project.
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| (4) | This Nineteenth Amendment, together with the Supply Agreement, contains the entire understanding of the Parties with respect to the subject matter hereof. Except as otherwise provided herein, the Supply Agreement has not been modified or amended and remains in full force and effect. All express or implied agreements and understandings that conflict with the terms of this Nineteenth Amendment, either oral or written, heretofore made with respect to subject matter herein are expressly superseded by this Nineteenth Amendment. |
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| (5) | This Nineteenth Amendment may be executed in counterparts, each of which shall be deemed an original, and all of which together shall constitute one and the same instrument. Counterparts may be signed and delivered by facsimile and/or via portable document format (pdf) (or similar format), each of which shall be binding when sent. |
IN WITNESS WHEREOF, the Parties have executed this Nineteenth Amendment to the Supply Agreement as of Nineteenth Amendment Effective Date.
Biberach, May 11, 2015
BOEHRINGER INGELHEIM BIOPHARMACEUTICALS GMBH
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| [*] |
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| VP Business & Contracts |
| Head of Legal Germany, Team Biberach |
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| San Francisco, June 1, 2015 |
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| FIBROGEN, INC. |
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| /s/ Jim Polarek |
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| Jim Polarek |
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| Vice President |
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Work Scope
(Version of March 16, 2015)
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