Development, Manufacturing and Supply Agreement Sample Contracts

1. DEFINITIONS
Development, Manufacturing and Supply Agreement • February 10th, 2006 • Biomimetic Therapeutics, Inc. • Delaware
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DEVELOPMENT, MANUFACTURING AND SUPPLY AGREEMENT
Development, Manufacturing and Supply Agreement • May 15th, 2015 • Celladon Corp • Biological products, (no disgnostic substances) • New Jersey

THIS DEVELOPMENT, MANUFACTURING AND SUPPLY AGREEMENT (“Agreement”) is made and entered into as of March 20, 2015 (the “Effective Date”), by and between CELLADON CORPORATION, a Delaware corporation with offices at 11988 El Camino Real, Suite 650, San Diego, CA 92130-3579, USA (“Celladon”), and NOVASEP, INC., a New Jersey corporation having offices at 23 Creek Circle, Boothwyn, PA 19061, USA (“Novasep”).

DEVELOPMENT, MANUFACTURING AND SUPPLY AGREEMENT
Development, Manufacturing and Supply Agreement • January 31st, 2012 • TEKMIRA PHARMACEUTICALS Corp • Pharmaceutical preparations • Delaware

This Development, Manufacturing and Supply Agreement (the “Agreement”) is entered into as of January 2, 2009 (the “Effective Date”), by and between Alnylam Pharmaceuticals, Inc., a corporation duly incorporated and existing under the laws of the State of Delaware, U.S.A, (“Alnylam”), and Tekmira Pharmaceuticals Corporation, a corporation duly organized and existing under the laws of the Province of British Columbia, Canada (“Tekmira”).

AMENDMENT TO THE DEVELOPMENT, MANUFACTURING AND SUPPLY AGREEMENT
Development, Manufacturing and Supply Agreement • May 10th, 2005 • Kensey Nash Corp • Surgical & medical instruments & apparatus • Pennsylvania

This Amendment to Development, Manufacturing and Supply Agreement (the “Amendment”), dated as of February 28, 2005 between Kensey Nash Corporation, a Delaware corporation, having its principal place of business at 55 East Uwchlan Avenue, Exton, PA 19341 (hereinafter referred to as “KNC”) and Orthovita, Inc., a Pennsylvania corporation, having its principal place of business at 45 Great Valley Parkway, Malvern, PA 19355 (hereinafter referred to as “Orthovita”).

FIRST AMENDMENT TO DEVELOPMENT, MANUFACTURING, AND SUPPLY AGREEMENT
Development, Manufacturing, and Supply Agreement • November 15th, 2010 • diaDexus, Inc. • Pharmaceutical preparations

This first amendment (the “First Amendment”) to DEVELOPMENT, MANUFACTURING, AND SUPPLY AGREEMENT (the “Agreement”) is made effective as of July 21, 2008, 2008 (the “Amendment Effective Date”) by and between DIADEXUS, INC., organized under the laws of Delaware and having its principal place of business at 343 Oyster Point Boulevard, South San Francisco, California 94080, United States of America (“diaDexus”), and DENKA SEIKEN, organized under the laws of Japan and having its principal place of business at 3-4-2 Nihonbashi Kayabacho, Chuo-ku, Tokyo 103-0025, Japan (“Denka Seiken”).

DEVELOPMENT, MANUFACTURING, AND SUPPLY AGREEMENT
Development, Manufacturing, and Supply Agreement • November 15th, 2010 • diaDexus, Inc. • Pharmaceutical preparations • California

THIS DEVELOPMENT, MANUFACTURING, AND SUPPLY AGREEMENT, together with exhibits attached hereto (the “Agreement”), effective as of March 27th, 2007 (the “Effective Date”), is entered into by and between DIADEXUS, INC., organized under the laws of Delaware and having its principal place of business at 343 Oyster Point Boulevard, South San Francisco, California 94080, United States of America (“diaDexus”), and DENKA SEIKEN, organized under the laws of Japan and having its principal place of business at 3-4-2 Nihonbashi Kayabacho, Chuo-ku, Tokyo 103-0025, Japan (“Denka Seiken”). diaDexus and Denka Seiken may each be referred to herein individually as a “Party” or, collectively, as “Parties.”

Portions of this exhibit have been omitted pursuant to a request for confidential treatment. The omitted portions, marked by [***], have been separately filed with the Securities and Exchange Commission. THIRD AMENDMENT TO DEVELOPMENT, MANUFACTURING...
Development, Manufacturing and Supply Agreement • July 23rd, 2010 • Biomimetic Therapeutics, Inc. • Surgical & medical instruments & apparatus

This Third Amendment is made effective as of the 2nd day of April, 2008, to the Development, Manufacturing and Supply Agreement made June 28, 2005 (the “Agreement”) by and between Kensey Nash Corporation, a Delaware corporation, having its principal place of business at 735 Pennsylvania Avenue, Exton, PA 18341 (hereinafter “KNC”) and BioMimetic Therapeutics, Inc. (formerly, BioMimetic Pharmaceuticals Inc.), a Delaware corporation, having its principal place of business at 389-A Nichol Mill Lane, Franklin, TN 37067 (hereinafter “BMTI”)(each, individually a “Party” and collectively, the “Parties”).

Portions of this exhibit have been omitted pursuant to a request for confidential treatment. The omitted portions, marked by [***], have been separately filed with the Securities and Exchange Commission. FIRST AMENDMENT TO DEVELOPMENT, MANUFACTURING...
Development, Manufacturing and Supply Agreement • July 23rd, 2010 • Biomimetic Therapeutics, Inc. • Surgical & medical instruments & apparatus

This First Amendment to Development, Manufacturing and Supply Agreement (the “Agreement Amendment”) dated as of August 15, 2006 (the “Effective Date”) between Kensey Nash Corporation, a Delaware corporation, having its principal place of business at 735 Pennsylvania Avenue, Exton, PA 19341 (hereinafter referred to as “KNC”) and BioMimetic Therapeutics, Inc. (formerly, BioMimetic Pharmaceuticals Inc.), a Delaware corporation, having its principal place of business at 389-A Nichol Mill Lane, Franklin, TN 37067 (hereinafter referred to as “BMPI”).

Contract
Development, Manufacturing and Supply Agreement • June 4th, 2013 • Revance Therapeutics, Inc. • Pharmaceutical preparations

[ ] = 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.

FIRST AMENDMENT TO DEVELOPMENT, MANUFACTURING AND SUPPLY AGREEMENT ___________________________________
Development, Manufacturing and Supply Agreement • May 14th, 2015 • Revance Therapeutics, Inc. • Pharmaceutical preparations

This First Amendment to the Development, Manufacturing and Supply Agreement (the “First Amendment”) is entered into as of the 13th day of May, 2015 (the “First Amendment Effective Date”) by and between DUOJECT MEDICAL SYSTEMS INC. (“DUOJECT”) and REVANCE THERAPEUTICS, INC. (“REVANCE”).

Second Amendment to the Development, Manufacturing and Supply Agreement
Development, Manufacturing and Supply Agreement • November 15th, 2010 • diaDexus, Inc. • Pharmaceutical preparations

This second amendment (the “Second Amendment”) to the DEVELOPMENT, MANUFACTURING AND SUPPLY AGREEMENT as amended on July 21, 2008 (collectively the “Agreement”) is effective as of June 1, 2009 (the “2nd Amendment Effective Date”), by and between DIADEXUS, INC., organized under the laws of Delaware and having its principal place of business at 343 Oyster Point Boulevard, South San Francisco, California 94080, United States of America (“diaDexus”), and DENKA SEIKEN, organized under the laws of Japan and having its principal place of business at 3-4-2 Nihonbashi Kayabacho, Chuo-ku, Tokyo 103-0025, Japan (“Denka Seiken”).

Contract
Development, Manufacturing and Supply Agreement • August 11th, 2017 • Recro Pharma, 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.

DEVELOPMENT, MANUFACTURING AND SUPPLY AGREEMENT BETWEEN ALKERMES PHARMA IRELAND LIMITED AND RECRO PHARMA, INC.
Development, Manufacturing and Supply Agreement • August 14th, 2015 • Recro Pharma, Inc. • Pharmaceutical preparations • Delaware

THIS DEVELOPMENT, MANUFACTURING AND SUPPLY AGREEMENT (this “Agreement”) is made and entered into as of July 10, 2015 (the “Effective Date”) by and between Alkermes Pharma Ireland Limited, a private limited company organized and existing under the laws of the Republic of Ireland (“Alkermes”), and Recro Pharma, Inc., a corporation organized and existing under the laws of Pennsylvania (“Recro”). Recro and Alkermes are sometimes hereinafter referred to each as a “Party” and collectively as the “Parties.”

DEVELOPMENT, MANUFACTURING AND SUPPLY AGREEMENT
Development, Manufacturing and Supply Agreement • June 30th, 2004 • Orthovita Inc • Surgical & medical instruments & apparatus • Pennsylvania

This AGREEMENT (the “Agreement”) dated as of March 25, 2003 (the “Effective Date”) between Kensey Nash Corporation, a Delaware corporation, having its principal place of business at 55 East Uwchlan Avenue, Exton, PA 19341 (hereinafter referred to as “KNC”) and Orthovita, Inc., a Pennsylvania corporation, having its principal place of business at 45 Great Valley Parkway, Malvern, PA 19355 (hereinafter referred to as “Orthovita”).

DEVELOPMENT, MANUFACTURING AND SUPPLY AGREEMENT
Development, Manufacturing and Supply Agreement • July 31st, 2006 • Health Chem Corp • Textile mill products • Delaware

This Development, Manufacturing and Supply Agreement (the “Agreement”), dated this 28th day of April, 2006, is made between Cure Therapeutics, Inc. ("CTI"), and Hercon Laboratories Corporation, a Delaware corporation ("Hercon").

AMENDMENT TO THE DEVELOPMENT, MANUFACTURING AND SUPPLY AGREEMENT
Development, Manufacturing and Supply Agreement • May 9th, 2005 • Orthovita Inc • Surgical & medical instruments & apparatus • Pennsylvania

This Amendment to Development, Manufacturing and Supply Agreement (the “Amendment”), dated as of February 28, 2005 between Kensey Nash Corporation, a Delaware corporation, having its principal place of business at 55 East Uwchlan Avenue, Exton, PA 19341 (hereinafter referred to as “KNC”) and Orthovita, Inc., a Pennsylvania corporation, having its principal place of business at 45 Great Valley Parkway, Malvern, PA 19355 (hereinafter referred to as “Orthovita”).

First Amendment to Development, Manufacturing and Supply Agreement
Development, Manufacturing and Supply Agreement • March 9th, 2017 • Recro Pharma, Inc. • Pharmaceutical preparations

This First Amendment to Development, Manufacturing and Supply Agreement (this “Amendment”) is made and entered into as of October 19, 2016 by and between Alkermes Pharma Ireland Limited, a private limited company organized and existing under the laws of the Republic of Ireland (“Alkermes”), and Recro Pharma, Inc., a corporation organized and existing under the laws of Pennsylvania (“Recro”), Recro and Alkermes are sometimes hereinafter referred to each as a “Party” and collectively as the ‘Parties.”

FIFTH AMENDMENT TO THE DEVELOPMENT, MANUFACTURING AND SUPPLY AGREEMENT
Development, Manufacturing and Supply Agreement • March 17th, 2008 • Orthovita Inc • Surgical & medical instruments & apparatus • Pennsylvania

This Fifth Amendment to the Development, Manufacturing and Supply Agreement (the “Fifth Amendment”), dated as of February 21, 2007, is between Kensey Nash Corporation, a Delaware corporation, having its principal place of business at 735 Pennsylvania Dr., Exton, PA 19341 (hereinafter referred to as “KNC”) and Orthovita, Inc., a Pennsylvania corporation, having its principal place of business at 77 Great Valley Parkway, Malvern, PA 19355 (hereinafter referred to as “Orthovita”).

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***] HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED. FIRST AMENDMENT TO DEVELOPMENT, MANUFACTURING AND...
Development, Manufacturing and Supply Agreement • October 22nd, 2019 • Baudax Bio, Inc. • Services-misc health & allied services, nec

THIS FIRST AMENDMENT TO DEVELOPMENT, MANUFACTURING AND SUPPLY AGREEMENT (this “Amendment”) is made and entered into as of October 19, 2016 by and between Alkermes Pharma Ireland Limited, a private limited company organized and existing under the laws of the Republic of Ireland (“Alkermes”), and Recro Pharma, Inc., a corporation organized and existing under the laws of Pennsylvania (“Recro”), Recro and Alkermes are sometimes hereinafter referred to each as a “Party” and collectively as the “Parties.”

Second Amendment to Development, Manufacturing and Supply Agreement
Development, Manufacturing and Supply Agreement • March 9th, 2017 • Recro Pharma, Inc. • Pharmaceutical preparations

This Second Amendment to Development, Manufacturing and Supply Agreement (this “Second Amendment”) is made and entered into as of February 1, 2017 by and between Alkermes Pharma Ireland Limited, a private limited company organized and existing under the laws of the Republic of Ireland (“Alkermes”), and Recro Pharma, Inc., a corporation organized and existing under the laws of Pennsylvania (“Recro”). Recro and Alkermes are sometimes hereinafter referred to each as a “Party” and collectively as the “Parties.”

Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote omissions. DEVELOPMENT, MANUFACTURING AND SUPPLY AGREEMENT
Development, Manufacturing and Supply Agreement • February 18th, 2011 • Alnylam Pharmaceuticals, Inc. • Pharmaceutical preparations • Delaware

This Development, Manufacturing and Supply Agreement (the “Agreement”) is entered into as of January 2, 2009 (the “Effective Date”), by and between Alnylam Pharmaceuticals, Inc., a corporation duly incorporated and existing under the laws of the State of Delaware, U.S.A, (“Alnylam”), and Tekmira Pharmaceuticals Corporation, a corporation duly organized and existing under the laws of the Province of British Columbia, Canada (“Tekmira”).

July 31, 2007
Development, Manufacturing and Supply Agreement • November 14th, 2007 • Novadel Pharma Inc • Pharmaceutical preparations • New Jersey
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Portions of this exhibit have been omitted pursuant to a request for confidential treatment. The omitted portions, marked by [***], have been separately filed with the Securities and Exchange Commission. SECOND AMENDMENT TO DEVELOPMENT, MANUFACTURING...
Development, Manufacturing and Supply Agreement • July 23rd, 2010 • Biomimetic Therapeutics, Inc. • Surgical & medical instruments & apparatus

This Second Amendment is made effective as of the first day of November, 2006, to the Development, Manufacturing and Supply Agreement made June 28, 2005 (“the Agreement”) by and between Kensey Nash Corporation, a Delaware corporation, having its principal place of business at 735 Pennsylvania Avenue, Exton, PA 19341 (hereinafter referred to as “KNC”) and BioMimetic Therapeutics, Inc. (formerly, BioMimetic Pharmaceuticals Inc.), a Delaware corporation, having its principal place of business at 389-A Nichol Mill Lane, Franklin, TN 37067 (hereinafter referred to as “BMTI”)(each, individually a “Party” and collectively, the “Parties”).

AND
Development, Manufacturing and Supply Agreement • November 15th, 2004 • Novadel Pharma Inc • Pharmaceutical preparations • New York
Portions of this exhibit have been omitted pursuant to a request for confidential treatment by BioMimetic Therapeutics, Inc. The omitted portions, marked by [**], have been separately filed with the Securities and Exchange Commission. FOURTH AMENDMENT...
Development, Manufacturing and Supply Agreement • March 10th, 2011 • Biomimetic Therapeutics, Inc. • Surgical & medical instruments & apparatus

This Fourth Amendment (the “Amendment”) to the Development, Manufacturing and Supply Agreement (the “Agreement”) dated as of September 30, 2010 between Kensey Nash Corporation, a Delaware corporation, having its principal place of business at 735 Pennsylvania Drive, Exton, PA 19341 (hereinafter referred to as “KNC”) and BioMimetic Therapeutics, Inc. (formerly, BioMimetic Pharmaceuticals Inc.), a Delaware corporation, having its principal place of business at 389-A Nichol Mill Lane, Franklin, TN 37067 (hereinafter referred to as “BMTI”).

Confidential Materials Omitted and Filed Separately with the Securities and Exchange Commission Pursuant to a Request for Confidential Treatment under Rule 406 under the Securities Act of 1933, as amended. Confidential Portions are marked: [***]...
Development, Manufacturing and Supply Agreement • December 11th, 2012 • Biosante Pharmaceuticals Inc • Biological products, (no disgnostic substances) • Wisconsin

This DEVELOPMENT, MANUFACTURING AND SUPPLY AGREEMENT (“this Agreement”), dated as of February 5, 2009 (the “Effective Date”), is by and between ANI PHARMACEUTICALS, INC., a Delaware Corporation (“ANI”), and COUNTY LINE PHARMACEUTICALS, LLC., a Wisconsin Limited Liability Corporation (“CLP”).

Development, manufacturing and supply agreement for several ANDAs
Development, Manufacturing and Supply Agreement • June 28th, 2024

Breckenridge Pharmaceutical has entered into a multi-product agreement with MSN Laboratories under which Breckenridge and MSN expect to commercialize several new ANDAs.

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***] HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED. SECOND AMENDMENT TO DEVELOPMENT, MANUFACTURING...
Development, Manufacturing and Supply Agreement • October 7th, 2019 • Baudax Bio, Inc. • Services-misc health & allied services, nec

THIS SECOND AMENDMENT TO DEVELOPMENT, MANUFACTURING AND SUPPLY AGREEMENT (this “Second Amendment”) is made and entered into as of February 1, 2017 by and between Alkermes Pharma Ireland Limited, a private limited company organized and existing under the laws of the Republic of Ireland (“Alkermes”), and Recro Pharma, Inc., a corporation organized and existing under the laws of Pennsylvania (“Recro”). Recro and Alkermes are sometimes hereinafter referred to each as a “Party” and collectively as the “Parties.”

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***] HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED. DEVELOPMENT, MANUFACTURING AND SUPPLY AGREEMENT...
Development, Manufacturing and Supply Agreement • October 22nd, 2019 • Baudax Bio, Inc. • Services-misc health & allied services, nec • Delaware

THIS DEVELOPMENT, MANUFACTURING AND SUPPLY AGREEMENT (this “Agreement”) is made and entered into as of July 10, 2015 (the “Effective Date”) by and between Alkermes Pharma Ireland Limited, a private limited company organized and existing under the laws of the Republic of Ireland (“Alkermes”), and Recro Pharma, Inc., a corporation organized and existing under the laws of Pennsylvania (“Recro”). Recro and Alkermes are sometimes hereinafter referred to each as a “Party” and collectively as the “Parties.”

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***] HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED. THIRD AMENDMENT TO DEVELOPMENT, MANUFACTURING AND...
Development, Manufacturing and Supply Agreement • October 22nd, 2019 • Baudax Bio, Inc. • Services-misc health & allied services, nec

THIS THIRD AMENDMENT TO DEVELOPMENT, MANUFACTURING AND SUPPLY AGREEMENT (this “Third Amendment”) is made and entered into as of June 15, 2017 by and between Alkermes Pharma Ireland Limited, a private limited company organized and existing under the laws of the Republic of Ireland (“Alkermes”), and Recro Ireland Limited, a private limited company organized and existing under the laws of the Republic of Ireland (“Recro”). Recro and Alkermes are sometimes hereinafter referred to each as a “Party” and collectively as the “Parties.”

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