EX-10.11 3 d650566dex1011.htm EX-10.11Clinical Supply Agreement • May 5th, 2020
Contract Type FiledMay 5th, 2020[*] = 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 406 of the Securities Act of 1933, as amended.
CLINICAL SUPPLY AGREEMENTClinical Supply Agreement • October 25th, 2013 • Xencor Inc • Pharmaceutical preparations • Delaware
Contract Type FiledOctober 25th, 2013 Company Industry JurisdictionTHIS CLINICAL SUPPLY AGREEMENT (this “Agreement”) is entered into and effective this 1st day of October, 2012 (“Effective Date”), by and between Cook Pharmica LLC (“COOK”), an Indiana limited liability company with offices at 1300 South Patterson Drive, Bloomington, Indiana 47403 and Xencor, Inc. (“CLIENT”), a Delaware corporation, with offices at 111 West Lemon Avenue, Second Floor, Monrovia, CA, 91016. In this Agreement, COOK and CLIENT each may be referred to individually as a “Party” and together as “Parties.”
CLINICAL SUPPLY AGREEMENTClinical Supply Agreement • August 9th, 2023 • Equillium, Inc. • Pharmaceutical preparations • New York
Contract Type FiledAugust 9th, 2023 Company Industry JurisdictionTHIS CLINICAL SUPPLY AGREEMENT (the “Agreement”) is entered into effective as of May 22, 2017 (the “Effective Date”), by and between EQUILLIUM, INC., a corporation organized under the laws of the State of Delaware, USA, with its principal office at 2223 Avenida de la Playa, Suite 108, La Jolla, California 92037, USA (“Equillium”), and BIOCON SA, a company organized under the laws of Switzerland with its principal place of business at c/o BDO SA, Rue De l’Avenir 2, 2800 Delemont, Switzerland (“Biocon”).
PROCESS DEVELOPMENT AND CLINICAL SUPPLY AGREEMENTClinical Supply Agreement • September 1st, 2005 • Skinmedica Inc • Pharmaceutical preparations • Maryland
Contract Type FiledSeptember 1st, 2005 Company Industry JurisdictionThis Clinical Supply Agreement (the “Agreement”) is made as of June 30, 2004, (the “Effective Date”) by and among Cambrex Bio Science Walkersville, Inc., a Delaware corporation (“CBSW”), Smith & Nephew Wound Management (La Jolla), a Delaware partnership (“SNWMLJ”), Inamed Medical Products Corporation, a California corporation (“Inamed”), and SkinMedica, Inc., a Delaware corporation (“SkinMedica”, and each of SNWMLJ, Inamed or SkinMedica individually referred to as “Client” and collectively referred to as “Clients”, and each of CBSW and Clients individually referred to as “Party” and collectively referred to as the “Parties”).
EXHIBIT 10.9 CLINICAL SUPPLY AGREEMENT Drug Abuse Sciences, ("DAS"), a corporation incorporated under the laws of the State of California, with offices located at 1430 O'Brien Drive, Suite E, Menlo Park, California, 94025 and SP Pharmaceuticals,...Clinical Supply Agreement • April 3rd, 2000 • Drugabuse Sciences Inc • Biological products, (no disgnostic substances) • New Mexico
Contract Type FiledApril 3rd, 2000 Company Industry Jurisdiction
CLINICAL SUPPLY AGREEMENTClinical Supply Agreement • April 27th, 2018 • Kiniksa Pharmaceuticals, Ltd. • Pharmaceutical preparations • New York
Contract Type FiledApril 27th, 2018 Company Industry JurisdictionTHIS CLINICAL SUPPLY AGREEMENT (“Agreement”) effective as of September 27, 2017 (“Effective Date”), is by and between Regeneron Pharmaceuticals, Inc. (“Regeneron”), and Kiniksa Pharmaceuticals, Ltd., a Bermuda exempted company (“KINIKSA”). Regeneron and KINIKSA are sometimes hereinafter referred to as a “Party” and collectively as the “Parties”.
Clinical Supply AgreementClinical Supply Agreement • April 29th, 2013 • Regado Biosciences Inc • Pharmaceutical preparations • Delaware
Contract Type FiledApril 29th, 2013 Company Industry JurisdictionThis CLINICAL SUPPLY AGREEMENT (the “Agreement”) is entered into as of the 28th day of March, 2012 (“Effective Date”) by and between REGADO BIOSCIENCES INC., a Delaware corporation, with a place of business located at 318 Blackwell Street, Suite 130, Durham, NC 27701 (“Client”), and ALTHEA TECHNOLOGIES, INC., a Delaware corporation, with a place of business located at 11040 Roselle Street, San Diego, CA 92121 (“Althea”). Althea and Client each hereinafter referred to also as a “Party” and collectively as the “Parties.”
CLINICAL SUPPLY AGREEMENTClinical Supply Agreement • February 8th, 2011 • Immunogen Inc • Pharmaceutical preparations
Contract Type FiledFebruary 8th, 2011 Company IndustryThis Clinical Supply Agreement (the “Agreement”) is made and entered into as of the date of the last signature written below (the “Effective Date”) by and between ImmunoGen, Inc., a corporation organized under the laws of the Commonwealth of Massachusetts, with its principal offices at 830 Winter Street, Waltham, Massachusetts 02451, U.S.A. (“ImmunoGen”) and Sicor Società Italiana Corticosteroidi S.r.l (in abbreviated form, Sicor S.r.l., hereafter referred to as “Sicor”), an Italian corporation with registered offices at Via Messina 38, 20154 Milan, Italy and principal offices at Via Terrazzano 77, 20017 Rho (MI), Italy (Sicor and ImmunoGen together the “Parties”, each a “Party”).
Amendment No. 29 to the Process Development and Clinical Supply AgreementClinical Supply Agreement • March 1st, 2017 • Fibrogen Inc • Pharmaceutical preparations
Contract Type FiledMarch 1st, 2017 Company IndustryThis Amendment No. 29 (the “29th Amendment”), effective as of December 20, 2016 (the “29th 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 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 5, 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
CLINICAL SUPPLY AGREEMENTClinical Supply Agreement • March 16th, 2007 • Sonus Pharmaceuticals Inc • In vitro & in vivo diagnostic substances • New York
Contract Type FiledMarch 16th, 2007 Company Industry JurisdictionTHIS CLINICAL SUPPLY AGREEMENT (the “Agreement”) is entered into as of the 1st day of June, 2006 (the “Effective Date”) by and between SCHERING AKTIENGESELLSCHAFT, a German corporation having a principal place of business at Müllerstraße 178, D-13342 Berlin, Germany (“Schering”) and SONUS PHARMACEUTICALS, INC., a Delaware corporation having a principal place of business at 22026 20th Avenue SE, Bothell, Washington 98021 (“Sonus”). Schering and Sonus are referred to individually as a “Party” and collectively as “Parties.”
Amendment No. 30 to the Process Development and Clinical Supply AgreementClinical Supply Agreement • March 1st, 2017 • Fibrogen Inc • Pharmaceutical preparations
Contract Type FiledMarch 1st, 2017 Company IndustryThis Amendment No. 30 (the “30th Amendment”), effective as of December 20, 2016 (the “30th 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 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 5, 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
ContractClinical Supply Agreement • September 24th, 2014 • Fibrogen Inc • Pharmaceutical preparations
Contract Type FiledSeptember 24th, 2014 Company Industry[ * ] = 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 406 of the Securities Act of 1933, as amended.
AMENDMENT NO. 12 TO THE PROCESS DEVELOPMENT AND CLINICAL SUPPLY AGREEMENTClinical Supply Agreement • October 1st, 2014 • Fibrogen Inc • Pharmaceutical preparations
Contract Type FiledOctober 1st, 2014 Company IndustryTHIS AMENDMENT NO. 12 (the “Twelfth Amendment”), effective as of August 01, 2013 (the “Twelfth Amendment Effective Date”) by and between Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Straße 65, 88397 Biberach an der Riss, Germany (“BI Pharma”) 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 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 5, 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
BI Contract No. 100704 CLINICAL SUPPLY AGREEMENTClinical Supply Agreement • November 3rd, 2015 • BioCancell Ltd. • Pharmaceutical preparations • New York
Contract Type FiledNovember 3rd, 2015 Company Industry JurisdictionWHEREAS, BioCancell’s Affiliated Company BioCancell Ltd. and BI RCV entered into a secrecy agreement (“CDA”) dated as of November 16, 2006, a material transfer agreement (“MTA”) dated as of April 3, 2013 and a Quality Agreement (“QA”) dated as of September 12, 2013; and
Amendment No. 26 to the Process Development and Clinical Supply AgreementClinical Supply Agreement • August 8th, 2016 • Fibrogen Inc • Pharmaceutical preparations
Contract Type FiledAugust 8th, 2016 Company IndustryThis Amendment No. 26 (the “26th Amendment”), effective as of the date of the last signature (the “26th 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 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 5, 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, Am
CLINICAL SUPPLY AGREEMENTClinical Supply Agreement • March 29th, 2002 • Neorx Corp • In vitro & in vivo diagnostic substances
Contract Type FiledMarch 29th, 2002 Company IndustryThis agreement (the “Agreement”) is entered into effective as of December 1, 2001 by and between The Curators of The University of Missouri, a public corporation of the State of Missouri, contracting on behalf of its Research Reactor Center, University of Missouri-Columbia (hereafter “University”), and NeoRx Corporation, a Washington corporation (“NeoRx”). University and NeoRx may hereafter from time to time be referred to collectively as the “Parties” and individually as a “Party.”
BI Contract No. 100704 CLINICAL SUPPLY AGREEMENTClinical Supply Agreement • February 5th, 2019 • Anchiano Therapeutics Ltd. • Pharmaceutical preparations • New York
Contract Type FiledFebruary 5th, 2019 Company Industry JurisdictionWHEREAS, BioCancell’s Affiliated Company BioCancell Ltd. and BI RCV entered into a secrecy agreement (“CDA”) dated as of November 16, 2006, a material transfer agreement (“MTA”) dated as of April 3, 2013 and a Quality Agreement ("QA") dated as of September 12, 2013; and
CLINICAL SUPPLY AGREEMENTClinical Supply Agreement • November 7th, 2008 • Halozyme Therapeutics Inc • Biological products, (no disgnostic substances) • New York
Contract Type FiledNovember 7th, 2008 Company Industry JurisdictionThis CLINICAL SUPPLY AGREEMENT (this “Agreement”) is entered into as of the 15th day of August, 2008 (“Effective Date”), by and between Cook Pharmica LLC a Delaware Limited Liability Company with offices at 1300 South Patterson Drive, Bloomington, Indiana 47403 (“COOK”) and HALOZYME, INC. a California corporation with an office at 11388 Sorrento Valley Road, San Diego, CA 92121 (“CLIENT”). In this Agreement, COOK and CLIENT each may be referred to individually as a “Party” and together as “Parties.”
AMENDMENT NO. 9 TO THE PROCESS DEVELOPMENT AND CLINICAL SUPPLY AGREEMENTClinical Supply Agreement • October 1st, 2014 • Fibrogen Inc • Pharmaceutical preparations
Contract Type FiledOctober 1st, 2014 Company IndustryTHIS AMENDMENT NO. 9 (the “Ninth Amendment”), effective as of November 26, 2012 (the “Ninth Amendment Effective Date”) by and between Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Straße 65, 88397 Biberach an der Riss, Germany (“BI Pharma”) 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 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 5, 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, and Amendment No. 8 (which is under negotiation simultaneously) (hereinafter together the “Supply Agreement”). BI Pharma and FibroGen sh
ARTICLE 1 DEFINITIONSClinical Supply Agreement • January 4th, 2002 • Isis Pharmaceuticals Inc • Pharmaceutical preparations • Delaware
Contract Type FiledJanuary 4th, 2002 Company Industry Jurisdiction
AMENDMENT NO. 10 TO THE PROCESS DEVELOPMENT AND CLINICAL SUPPLY AGREEMENTClinical Supply Agreement • September 24th, 2014 • Fibrogen Inc • Pharmaceutical preparations
Contract Type FiledSeptember 24th, 2014 Company IndustryTHIS AMENDMENT NO. 10 (the “Tenth Amendment”), effective as of June 21, 2013 (the “Tenth Amendment Effective Date”) by and between Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Straße 65, 88397 Biberach an der Riss, Germany (“BI Pharma”) 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 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 5, 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 and Amendment No. 9, effective as of November 26, 2012 (hereinafter together the “Supply Agr
Amendment No. 31 to the Process Development and Clinical Supply AgreementClinical Supply Agreement • May 9th, 2017 • Fibrogen Inc • Pharmaceutical preparations
Contract Type FiledMay 9th, 2017 Company IndustryThis Amendment No. 31 (the “31st Amendment”), effective as of the date of the last signature (the “31st 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 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 5, 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, Am
Amendment No. 24 to the Process Development and Clinical Supply AgreementClinical Supply Agreement • August 8th, 2016 • Fibrogen Inc • Pharmaceutical preparations
Contract Type FiledAugust 8th, 2016 Company IndustryThis Amendment No. 24 (the “24th Amendment”), retroactively effective as of September 15, 2015 (the “24th 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 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 5, 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,
CLINICAL SUPPLY AGREEMENT Dated as of July 30, 2019 By and Between Brickell Biotech, Inc. and Kaken Pharmaceutical Co., Ltd.Clinical Supply Agreement • June 8th, 2020 • Brickell Biotech, Inc. • Biological products, (no disgnostic substances) • New York
Contract Type FiledJune 8th, 2020 Company Industry JurisdictionTHIS CLINICAL SUPPLY AGREEMENT is made as of July 30, 2019 (the “Effective Date”) by and between Kaken Pharmaceutical Co. Ltd., a company legally organized and existing under the laws of Japan (“Kaken”), and Brickell Biotech, Inc., a Delaware corporation (“Brickell”). Kaken and Brickell may be referred to herein as a “Party” or, collectively, as “Parties.”
AMENDMENT NO. 6 TO THE PROCESS DEVELOPMENT AND CLINICAL SUPPLY AGREEMENTClinical Supply Agreement • October 1st, 2014 • Fibrogen Inc • Pharmaceutical preparations
Contract Type FiledOctober 1st, 2014 Company Industry[ * ] = 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 406 of the Securities Act of 1933, as amended.
AMENDMENT NO. 7 TO THE PROCESS DEVELOPMENT AND CLINICAL SUPPLY AGREEMENTClinical Supply Agreement • September 24th, 2014 • Fibrogen Inc • Pharmaceutical preparations
Contract Type FiledSeptember 24th, 2014 Company IndustryTHIS AMENDMENT NO. 7 (the “Seventh Amendment”), effective as of January 01, 2012 (the “Seventh Amendment Effective Date”) by and between Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Straße 65, 88397 Biberach an der Riss, Germany (“BI Pharma”) 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 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 5, 2010, Amendment No. 4, effective as of January 24, 2011, Amendment No. 5, effective as of April 15, 2011, and Amendment No. 6, effective as of May 26, 2011 (hereinafter together the “Supply Agreement”). BI Pharma and FibroGen shall be referred to individually herein as a “Party”, and collectively as, the “Parties”.
CLINICAL SUPPLY AGREEMENT between LAWRENCE LABORATORIES and CADENCE PHARMACEUTICALS, INC. dated as of February 21, 2006Clinical Supply Agreement • September 25th, 2006 • Cadence Pharmaceuticals Inc • Pharmaceutical preparations • New York
Contract Type FiledSeptember 25th, 2006 Company Industry JurisdictionThis Clinical Supply Agreement (the “Agreement”) is entered into as of February 21, 2006 (the “Execution Date”) by and among Lawrence Laboratories, an indirect wholly-owned subsidiary of Parent (as defined below) and a corporation organized under the laws of Ireland with its registered office at Unit 12, Distribution Centre, Shannon Industrial Estate, Shannon, County Clare, Ireland (“BMS” ), Cadence Pharmaceuticals, Inc., a Delaware corporation having an address at 12730 High Bluff Drive, San Diego, California 92130 (“Cadence” ), and, solely for the purposes of Section 9.15 hereof, Bristol-Myers Squibb Company, a Delaware corporation having an address at 345 Park Avenue, New York, New York 10154 (“Parent”) and is effective as of March 29, 2006 (the “Effective Date” ). BMS and Cadence are sometimes collectively referred to herein collectively as the “Parties” and each individually as a “Party.”
AMENDMENT NO. 18 TO THE PROCESS DEVELOPMENT AND CLINICAL SUPPLY AGREEMENTClinical Supply Agreement • November 12th, 2015 • Fibrogen Inc • Pharmaceutical preparations
Contract Type FiledNovember 12th, 2015 Company IndustryTHIS AMENDMENT No. 18 (the “Eighteenth Amendment”), effective as of February 15, 2015 (the “Eighteenth Amendment Effective Date”) by and between Boehringer lngelheim 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,
REDACTED - AS FILED THE MARKED PORTIONS OF THIS CLINICAL SUPPLY AGREEMENT HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT CARDINAL HEALTH CLINICAL SUPPLY AGREEMENTClinical Supply Agreement • October 16th, 2006 • Generex Biotechnology Corp • Pharmaceutical preparations • Ohio
Contract Type FiledOctober 16th, 2006 Company Industry JurisdictionThis Clinical Supply Agreement (“Agreement”) is made as of this ___day of September, 2006 (“Effective Date”), by and between Generex Biotechnology Corporation, a Delaware corporation, with a place of business at 33 Harbour Square, Toronto, ON, Canada M5J 2G2 (hereinafter “Client”) and Cardinal Health PTS, LLC, a Delaware limited liability company, with a place of business at 160 Cardinal Health Way, Morrisville, NC 27560 (hereinafter “Cardinal Health”).
Clinical Supply AgreementClinical Supply Agreement • July 23rd, 2013 • District of Columbia
Contract Type FiledJuly 23rd, 2013 JurisdictionThe following agreement serves as the basis for the distribution of [collaborator’s agents__________by NCI for DCTD supported clinical trials
AMENDMENT NO. 8 TO THE PROCESS DEVELOPMENT AND CLINICAL SUPPLY AGREEMENTClinical Supply Agreement • October 1st, 2014 • Fibrogen Inc • Pharmaceutical preparations
Contract Type FiledOctober 1st, 2014 Company IndustryTHIS AMENDMENT NO. 8 (the “Eighth Amendment”), effective retroactively as of July 10, 2012 (the “Eighth Amendment Effective Date”) by and between Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Straße 65, 88397 Biberach an der Riss, Germany (“BI Pharma”) 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 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 5, 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 and Amendment No. 7, effective as of January 01, 2012 (hereinafter together the “Supply Agreement”). BI Pharma and FibroGen shall be referred to individually herein as a “Party
AMENDMENT NO. 11 TO THE PROCESS DEVELOPMENT AND CLINICAL SUPPLY AGREEMENTClinical Supply Agreement • October 1st, 2014 • Fibrogen Inc • Pharmaceutical preparations
Contract Type FiledOctober 1st, 2014 Company IndustryTHIS AMENDMENT NO. 11 (the “Eleventh Amendment”), effective as of July 09, 2013 (the “Eleventh Amendment Effective Date”) by and between Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Straße 65, 88397 Biberach an der Riss, Germany (“BI Pharma”) 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 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 5, 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 and Amendment No. 10, effective as
Clinical Supply AgreementClinical Supply Agreement • July 24th, 2020 • District of Columbia
Contract Type FiledJuly 24th, 2020 Jurisdiction
AMENDMENT NO. 5 TO THE PROCESS DEVELOPMENT AND CLINICAL SUPPLY AGREEMENTClinical Supply Agreement • September 24th, 2014 • Fibrogen Inc • Pharmaceutical preparations
Contract Type FiledSeptember 24th, 2014 Company IndustryTHIS AMENDMENT NO. 5 (the “Fifth Amendment”) is effective as of April 15, 2011 (the “Fifth Amendment Effective Date”) by and between Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Straße 65, 88397 Biberach an der Riss, Germany (“BI Pharma”) 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 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, the Amendment No. 1, effective as of May 28, 2009, the Amendment No. 3, effective as of November 5, 2010, and the Amendment No. 4, effective as of January 24, 2011 (hereinafter together the “Supply Agreement”). BI Pharma and FibroGen shall be referred to individually herein as a “Party”, and collectively as, the “Parties”.
AMENDMENT NO. 13 TO THE PROCESS DEVELOPMENT AND CLINICAL SUPPLY AGREEMENTClinical Supply Agreement • October 1st, 2014 • Fibrogen Inc • Pharmaceutical preparations
Contract Type FiledOctober 1st, 2014 Company IndustryTHIS AMENDMENT NO. 13 (the “Thirteenth Amendment”), effective as of March 06, 2014 (the “Thirteenth 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 5, 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, 201