Development and Clinical Supply Agreement Sample Contracts

EX-10.27 33 dex1027.htm DEVELOPMENT AND CLINICAL SUPPLY AGREEMENT DEVELOPMENT AND CLINICAL SUPPLY AGREEMENT DPT LABORATORIES, LTD. AND PEPLIN, INC. **** Certain confidential information contained in this document, marked with four asterisks, has been...
Development and Clinical Supply Agreement • May 5th, 2020 • New Jersey

This Development And Manufacturing Agreement (this “Agreement”), effective as of this October 23, 2007 (the “Effective Date”), is made by and between Peplin, Inc., a Delaware corporation with its principal place of business at 6475 Christie Avenue, Emeryville, California 94608 (“COMPANY”), and DPT Laboratories, Ltd., a Texas Limited Partnership with its principal place of business at 307 E. Josephine, San Antonio, Texas 78215 (“DPT”).

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DEVELOPMENT AND CLINICAL SUPPLY AGREEMENT DPT Laboratories, Ltd. And Peplin, Inc.
Development and Clinical Supply Agreement • December 28th, 2007 • Peplin Inc • Pharmaceutical preparations • New Jersey

This Development And Manufacturing Agreement (this “Agreement”), effective as of this October 23, 2007 (the “Effective Date”), is made by and between Peplin, Inc., a Delaware corporation with its principal place of business at 6475 Christie Avenue, Emeryville, California 94608 (“COMPANY”), and DPT Laboratories, Ltd., a Texas Limited Partnership with its principal place of business at 307 E. Josephine, San Antonio, Texas 78215 (“DPT”).

EX-10.58 3 dex1058.htm DRUG PRODUCT 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...
Development and Clinical Supply Agreement • May 5th, 2020 • Delaware

THIS DRUG PRODUCT DEVELOPMENT AND CLINICAL SUPPLY AGREEMENT (the “Agreement”) is effective as of the 28th day of April 2006 (the “Effective Date”).

Drug Product Development and Clinical Supply Agreement
Development and Clinical Supply Agreement • January 9th, 2008 • Omeros Corp • California

OMEROS CORPORATION, a corporation organized and existing under the laws of Washington, with its principal offices located at 1420 Fifth Avenue, Suite 2600, Seattle, Washington 98101 (hereinafter referred to as “CLIENT”)

AMENDMENT NO. 23 TO THE PROCESS DEVELOPMENT AND CLINICAL SUPPLY AGREEMENT
Development and Clinical Supply Agreement • November 12th, 2015 • Fibrogen Inc • Pharmaceutical preparations

This AMENDMENT No. 23 (the “Twenty-third Amendment”), effective as of September 01, 2015 (the “Twenty-Third 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 lngelheim 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

FIRST AMENDMENT TO MASTER PRODUCT DEVELOPMENT AND CLINICAL SUPPLY AGREEMENT
Development and Clinical Supply Agreement • April 25th, 2014 • Alder Biopharmaceuticals Inc • Pharmaceutical preparations

THIS FIRST AMENDMENT TO MASTER PRODUCT DEVELOPMENT AND CLINICAL SUPPLY AGREEMENT (“Amendment”) is entered into effective as of March 15, 2013 (the “Effective Date”) between Alder Biopharmaceuticals, Inc., a Delaware corporation, with its principal offices at 11804 North Creek Parkway South, Bothell, WA 98011 (“Client”) and Althea Technologies, Inc., a Delaware corporation, with its principal offices at 11040 Roselle Street, San Diego, CA 92121 (“Althea”), in order to amend that certain Master Product Development and Clinical Supply Agreement between Client and Althea dated March 21, 2011 (the “Agreement”). The parties agree as follows:

AMENDMENT NO.19 TO THE PROCESS DEVELOPMENT AND CLINICAL SUPPLY AGREEMENT
Development and Clinical Supply Agreement • November 12th, 2015 • Fibrogen Inc • Pharmaceutical preparations

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, 20

FIRST AMENDMENT TO MASTER PRODUCT DEVELOPMENT AND CLINICAL SUPPLY AGREEMENT
Development and Clinical Supply Agreement • May 1st, 2014 • Alder Biopharmaceuticals Inc • Pharmaceutical preparations

THIS FIRST AMENDMENT TO MASTER PRODUCT DEVELOPMENT AND CLINICAL SUPPLY AGREEMENT (“Amendment”) is entered into effective as of March 15, 2013 (the “Effective Date”) between Alder Biopharmaceuticals, Inc., a Delaware corporation, with its principal offices at 11804 North Creek Parkway South, Bothell, WA 98011 (“Client”) and Althea Technologies, Inc., a Delaware corporation, with its principal offices at 11040 Roselle Street, San Diego, CA 92121 (“Althea”), in order to amend that certain Master Product Development and Clinical Supply Agreement between Client and Althea dated March 21, 2011 (the “Agreement”). The parties agree as follows:

AMENDMENT NO. 16 TO THE PROCESS DEVELOPMENT AND CLINICAL SUPPLY AGREEMENT
Development and Clinical Supply Agreement • November 12th, 2015 • Fibrogen Inc • Pharmaceutical preparations

THIS AMENDMENT No. 16 (the “Sixteenth Amendment”), effective as of December 08, 2014 (the “Sixteenth Amendment Effective Date”) by and between BOEHRINGER INGELHEIM BIOPHARMACEUTICALS GMBH, Binger Str. 173, 55216 Ingelheim, German y (“BI”) and FIBROGEN, INC., 409 Illinois Street, San Francisco, CA 94158, USA (“FibroGen”), amends the Process Development and Clinical Supply Agreement originally 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 Apri1 15, 2011, Amendment No. 6, effective as of May 26, 2011, Amendment No. 7, effective as of January I , 2012, Amendment No. 8, effective a

Drug Product Development and Clinical Supply Agreement
Development and Clinical Supply Agreement • May 15th, 2009 • Omeros Corp • Pharmaceutical preparations • California

OMEROS CORPORATION, a corporation organized and existing under the laws of Washington, with its principal offices located at 1420 Fifth Avenue, Suite 2600, Seattle, Washington 98101 (hereinafter referred to as “CLIENT”)

SOFTGEL DEVELOPMENT AND CLINICAL SUPPLY AGREEMENT
Development and Clinical Supply Agreement • September 18th, 2006 • Tenby Pharma Inc • Blank checks • Ohio

This Softgel Development and Clinical Supply Agreement (“Agreement”) is made as of this 5th day of October, 2005, by and between Sytera Inc., having its registered office at 505 Coast Boulevard South, Suite 412, La Jolla, California 92037 (hereinafter “Client”), and Cardinal Health PTS, LLC, a limited liability company organized under the laws of the State of Delaware, through its Pharmaceutical Development group with a place of business at 14 Schoolhouse Road, Somerset, New Jersey 08873 (hereinafter “Cardinal Health”).

AMENDMENT NO. 20 TO THE PROCESS DEVELOPMENT AND CLINICAL SUPPLY AGREEMENT
Development and Clinical Supply Agreement • November 12th, 2015 • Fibrogen Inc • Pharmaceutical preparations

THIS AMENDMENT No. 20 (the “Twentieth Amendment”), effective as of June 01, 2015 (the “Twentieth 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 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, 201 I , Amendment No. 7, effective as of January 01, 2012, Amendment No. 8, effective as of July 10, 2

Development and Clinical Supply Agreement Contract Number: E86A1D4C-B3F9 Between Rentschler Biotechnologie GmbH - and - Ultragenyx Pharmaceutical Inc.
Development and Clinical Supply Agreement • November 8th, 2013 • Ultragenyx Pharmaceutical Inc. • Pharmaceutical preparations

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

AMENDMENT NO. 15 TO THE PROCESS DEVELOPMENT AND CLINICAL SUPPLY AGREEMENT
Development and Clinical Supply Agreement • November 12th, 2015 • Fibrogen Inc • Pharmaceutical preparations

THIS AMENDMENT No. 15 (the “Fifteenth Amendment “), effective as of October 20, 2014 (the “Fifteenth Amendment Effective Date”) by and between Boehringer lngelheim Biopharmaceuticals GmbH, Binger Str. 173, 55216 lngelheim, 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 lngelheim 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. 21 TO THE PROCESS DEVELOPMENT AND CLINICAL SUPPLY AGREEMENT
Development and Clinical Supply Agreement • November 12th, 2015 • Fibrogen Inc • Pharmaceutical preparations

This AMENDMENT No. 21 (the “Twenty-first Amendment”), effective as of May 29, 2015 (the “Twenty­ first Amendment Effective Date”) by and between Boehringer lngelheim Biopharmaceuticals GmbH, Binger Str. 173, 55216 lngelheim, 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 lngelheim 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, 201 l, Amendment No. 7, effective as of January 01 , 2012, Amendment No. 8, effective as of July 10

AMENDMENT NO.17 TOTHE PROCESS DEVELOPMENT AND CLINICAL SUPPLY AGREEMENT
Development and Clinical Supply Agreement • November 12th, 2015 • Fibrogen Inc • Pharmaceutical preparations

THIS AMENDMENT No. 17 (the “Seventeenth Amendment”), effective as of December 08, 2014 (the “Seventeenth Amendment Effective Date”) by and between BOEHRINGER INGELHEIM BIOPHARMACEUTICALS GMBH, Binger Str. 173, 55216 lngelheim, 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 1, 2012, Amendment No. 8, effective as of July 10, 2

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