DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENTDevelopment and Manufacturing Services Agreement • September 5th, 2017 • Rhythm Pharmaceuticals, Inc. • Pharmaceutical preparations • New York
THIS DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT is made as of July 17, 2013 (the “Effective Date”) by and between RHYTHM METABOLIC, INC., a Delaware corporation with offices at 855 Boylston Street, 11th Floor, Boston, MA 02116, USA (“Rhythm”) and PEPTISYNTHA Inc., a US company incorporated under the laws of the state of Delaware with its registered office at 3333 Richmond Avenue, Houston Texas 77098, USA (“Manufacturer”).
DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENTDevelopment and Manufacturing Services Agreement • November 4th, 2013 • Xencor Inc • Pharmaceutical preparations • Ohio
This Development and Manufacturing Services Agreement (“Agreement”) is made as of this 15th day of September, 2005 (“Effective Date”), by and between Xencor, Inc., a Delaware corporation, with a place of business at 111 West Lemon Avenue, Monrovia, CA 91016 (hereinafter “Xencor”) and Cardinal Health PTS, LLC, a Delaware limited liability company, by and through its Gala Biotech business unit with a place of business at 8137 Forsythia Street, Middleton, Wisconsin 53562 (hereinafter “Cardinal Health”).
CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS. PROCESS DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENTDevelopment and Manufacturing Services Agreement • June 22nd, 2012 • TESARO, Inc. • Pharmaceutical preparations • New York
This Process Development and Manufacturing Services Agreement is entered into as of the 28th day of March, 2012 (the “Effective Date”), by and between Hovione Inter Limited, a Swiss corporation, having a principal place of business at Bahnhofstrasse 21 CH-6000 Lucerne 7 Switzerland (together with its Affiliates “Hovione”), and TESARO, Inc., a Delaware corporation, having a principal place of business at 1000 Winter Street, Suite 3300, Waltham, MA 02451 (“Client”). Each of Hovione and Client may be referred to in this Agreement, individually, as a “Party” and, collectively, as the “Parties”.
DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENTDevelopment and Manufacturing Services Agreement • July 17th, 2020 • Freeline Therapeutics Holdings PLC • Biological products, (no disgnostic substances) • New York
This DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT (this “Agreement”), effective as of this 6th day of October, 2017 (the “Effective Date”), between, Freeline Therapeutics Limited (“Customer”), having its principal place of business at 215 Euston Road, London NW1 2BE, UK, and Brammer Bio MA, LLC, a Delaware limited liability company with offices at 250 Binney Street, Cambridge, MA 02142 (“Brammer”). Customer and Brammer are referred to herein each as a “Party” and collectively as the “Parties”.
DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT (the “Agreement”)Development and Manufacturing Services Agreement • May 22nd, 2020 • Vaxcyte, Inc. • Biological products, (no disgnostic substances) • Delaware
WHEREAS, Customer is engaged in the development and research of certain products and requires assistance in the development and manufacture of product:
DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENTDevelopment and Manufacturing Services Agreement • September 5th, 2017 • Rhythm Pharmaceuticals, Inc. • Pharmaceutical preparations • England
THIS DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT is made as of December 21, 2016 (the “Effective Date”) by and between RHYTHM PHARMACEUTICALS, INC., a Delaware corporation with offices at 500 Boylston Street, 11th Floor, Boston, MA 02116, USA (“Rhythm”) and RECIPHARM MONTS SAS, a French corporation with an office at 18 route de Montbazon, 37 260 Monts, France (“Manufacturer”).
DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENTDevelopment and Manufacturing Services Agreement • March 31st, 2015 • Anterios Inc • Pharmaceutical preparations • New York
THIS DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT is made and entered into as of August 17, 2011 (the “Effective Date”) by and between Anterios, Inc., a Delaware corporation having an address at 142 West 57th (Suite 4A), New York, NY 10019, (“Anterios”) and QuaDPharma, a New York corporation having an address at 11342 Main St., Clarence, New York, 14031 (“Manufacturer”).
Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Double askterisks denote omissions. DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT between LONZA SALES AG and KOLLTAN PHARMACEUTICALS, INC.Development and Manufacturing Services Agreement • September 12th, 2014 • Kolltan Pharmaceuticals Inc • Pharmaceutical preparations • New York
DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENTDevelopment and Manufacturing Services Agreement • October 24th, 2011 • Radius Health, Inc. • Blank checks • New York
THIS DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT is made and entered into as of October 16, 2007 (the “Effective Date”) by and between RADIUS HEALTH, INC., a Delaware corporation having an address at 300 Technology Square, 5th Floor, Cambridge, MA 02139 (together with its Affiliates, “RADIUS”) and LONZA Sales Ltd, a Swiss company having an address at Muenchensteinerstrasse 38, CH-4002 Basel, Switzerland (together with its Affiliates, “Manufacturer”).
DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENTDevelopment and Manufacturing Services Agreement • March 13th, 2013 • Portola Pharmaceuticals Inc • Pharmaceutical preparations • New York
THIS DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT is made and entered into as of January 17, 2007 (the “Effective Date”) by and between Portola Pharmaceuticals, Inc., a Delaware corporation, having a principal place of business at 270 East Grand Avenue, Suite 22, South San Francisco, California 94080 (Telephone: 650-246-7300, Facsimile: 650-246-7776) (“Portola”) and Hovione Inter Limited, a Swiss company having its principal place of business at Bahnhofstrasse 21 CH-6000 Lucerne 7 Switzerland, (“Hovione,” together with its Affiliates “Manufacturer”).
DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENTDevelopment and Manufacturing Services Agreement • March 26th, 2024 • AVROBIO, Inc. • Biological products, (no disgnostic substances) • New York
THIS DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT is made as of May 6, 2022(the Effective Date”)by and between Tectonic Therapeutic, Inc., a Delaware corporation with an office at 490 Arsenal Way, Suite 210, Watertown, MA 02472 U.S.A. (“Tectonic”) and WuXi Biologics (Hong Kong) Limited, a Hong Kong corporation with an office at Flat/RM826, 8/F Ocean Centre Harbour City, 5 Canton Road TST, Hong Kong (“Manufacturer”).
DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENTDevelopment and Manufacturing Services Agreement • October 3rd, 2022 • Yumanity Therapeutics, Inc. • Pharmaceutical preparations • New York
THIS DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT is made on November 22, 2019 (the “Effective Date”) by and between Kineta Chronic Pain, LLC, a Washington limited liability company with offices at 219 Terry Avenue North, Suite 300, Seattle, WA 98109 (“COMPANY” or “Kineta”) and AmbioPharm, Inc., a California corporation with an office at 1024 Dittman Court, North Augusta, SC 29842, (“AmbioPharm”).
AMENDMENT NO. 5 TO DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENTDevelopment and Manufacturing Services Agreement • February 27th, 2020 • Atara Biotherapeutics, Inc. • Biological products, (no disgnostic substances) • New York
This Amendment No. 5 to the Development and Manufacturing Services Agreement (“Fifth Amendment”) is made, entered into and effective as of the date of last signature below (the “Fifth Amendment Effective Date”) by and between ATARA BIOTHERAPEUTICS, INC., a Delaware corporation with offices at 611 Gateway Boulevard, Suite 900, South San Francisco, California 94080 (“Atara”); and COGNATE BIOSERVICES INC., a Delaware corporation with offices at 4600 East Shelby Drive, Suite 108, Memphis, TN 38118 (“Manufacturer”). Each of Atara and Manufacturer are referred to in this Fifth Amendment as a “Party” and together, the “Parties.” All capitalized terms used, but not otherwise defined herein, shall have the same meaning ascribed to them in the Services Agreement (as defined below).
AMENDMENT NO. 9 to the DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT dated 6th September 2017 between LONZA SALES AG and LONZA AG and DENALI THERAPEUTICS INC.Development and Manufacturing Services Agreement • February 27th, 2023 • Denali Therapeutics Inc. • Biological products, (no disgnostic substances)
LONZA SALES AG incorporated and registered in Switzerland whose registered office is at Muenchensteinerstrasse 38, CH-4002, Basel, Switzerland; and
Amendment No. 6 to the DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT Dated 6th September 2017 Between LONZA SALES AG and DENALI THERAPEUTICS lNC.Development and Manufacturing Services Agreement • February 26th, 2021 • Denali Therapeutics Inc. • Biological products, (no disgnostic substances)
Master Services Agreement for Drug Product Development and Manufacturing (the “Agreement”)Development and Manufacturing Services Agreement • February 27th, 2024 • Vaxcyte, Inc. • Biological products, (no disgnostic substances)
WHEREAS, Customer is engaged in the development and research of certain products and requires assistance in the development and manufacture of product;
AMENDED AND RESTATED AMENDMENT NO. 2 TO DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENTDevelopment and Manufacturing Services Agreement • November 7th, 2019 • Atara Biotherapeutics, Inc. • Biological products, (no disgnostic substances)
This Amended and Restated Amendment No. 2 to the Development and Manufacturing Services Agreement (“Amended and Restated Second Amendment”) is made and entered into, effective as of November 4, 2018 (the “Amended and Restated Second Amendment Effective Date”), by and between Cognate BioServices, Inc., a Delaware corporation with an office at 7513 Connelly Drive, Suite I, Hanover, MD 21076 (“Manufacturer”), and Atara Biotherapeutics, Inc., a Delaware corporation located at 611 Gateway Boulevard, Suite #900, South San Francisco, CA 94080 (“Atara”). Each of Atara and Manufacturer are referred to in this Amended and Restated Second Amendment as a “party” and together, the “parties.”
ConfidentialDevelopment and Manufacturing Services Agreement • March 19th, 2018 • Denali Therapeutics Inc. • Biological products, (no disgnostic substances)
SPECIFIC TERMS IN THIS EXHIBIT HAVE BEEN REDACTED BECAUSE CONFIDENTIAL TREATMENT FOR THOSE TERMS HAS BEEN REQUESTED. THE REDACTED MATERIAL HAS BEEN SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION, AND THE TERMS HAVE BEEN MARKED AT THE APPROPRIATE PLACE WITH THREE ASTERISKS [***].
AMENDMENT NO. 3 TO DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENTDevelopment and Manufacturing Services Agreement • February 25th, 2016 • Radius Health, Inc. • Pharmaceutical preparations • New York
This Amendment No. 3 (the “Amendment”) to the DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT is entered into on December 31, 2015 by and between Radius Health Inc., a Delaware corporation, with its principal office at 950 Winter Street, Waltham, MA 02451, United States of America (“RADIUS”) and LONZA Sales Ltd, a Swiss company having an address at Muenchensteinerstrasse 38, CH-4002 Basel, Switzerland (together with its Affiliates, “Manufacturer”) and upon execution will be incorporated into the Development and Manufacturing Services Agreement between RADIUS and Manufacturer dated October 16, 2007 (the “Original Agreement”), as amended to date. Capitalized terms used in this Amendment will have the same meaning as set forth in the Agreement as amended to date.
A request for confidential treatment has been made with respect to portions of the following document that are marked with [*]. The redacted portions have been filed separately with the SEC. First Amendment to Development and Manufacturing Services...Development and Manufacturing Services Agreement • April 30th, 2015 • Anterios Inc • Pharmaceutical preparations
This first amendment to the DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT (hereinafter referred to as the “First Amendment”) is entered into between the QuaDPharma, LLC, a Delaware Limited Liability Company (“QuaDPharma”); and Anterios, Inc., a Delaware corporation, with offices located at 60 East 42nd St, New York, New York 10165 (“Anterios”); and is made as of April 23, 2015.
DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENTDevelopment and Manufacturing Services Agreement • November 14th, 2023 • Senti Biosciences, Inc. • Biological products, (no disgnostic substances) • Delaware
THIS DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT (this “Agreement”) is made as of August 7, 2023 (the “Effective Date”) by and between GeneFab, LLC, a Delaware limited company (“Provider”), with offices at 1101 Marina Village Parkway, Suite 201, Alameda, CA 94502, and Senti Biosciences, Inc., a Delaware corporation (“Senti”), with offices at 2 Corporate Drive, First Floor, South San Francisco, CA 94080. Provider and Senti are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”
DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENTDevelopment and Manufacturing Services Agreement • March 10th, 2015 • Radius Health, Inc. • Pharmaceutical preparations • New York
THIS DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT is made and entered into as of October 16, 2007 (the “Effective Date”) by and between RADIUS HEALTH, INC., a Delaware corporation having an address at 300 Technology Square, 5th Floor, Cambridge, MA 02139 (together with its Affiliates, “RADIUS”) and LONZA Sales Ltd, a Swiss company having an address at Muenchensteinerstrasse 38, CH-4002 Basel, Switzerland (together with its Affiliates, “Manufacturer”).
AMENDMENT NO. 2 TO DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENTDevelopment and Manufacturing Services Agreement • February 11th, 2014 • Radius Health, Inc. • Blank checks • New York
This Amendment No. 2 (the “Amendment”) to the DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT is entered into on January 30, 2014 by and between Radius Health Inc., a Delaware corporation, with its principal office at 201 Broadway — 6th floor, Cambridge, MA 02139, United States of America (“RADIUS”), and LONZA Sales Ltd, a Swiss company having an address at Muenchensteinerstrasse 38, CH-4002 Basel, Switzerland (together with its Affiliates, “Manufacturer”), and upon execution will be incorporated into the Development and Manufacturing Services Agreement between RADIUS and Manufacturer dated October 16, 2007 (the “Original Agreement”), as amended to date. Capitalized terms in this Amendment will have the same meanings as set forth in the Agreement, as amended to date.
AMENDMENT NO. 3Development and Manufacturing Services Agreement • November 8th, 2018 • Denali Therapeutics Inc. • Biological products, (no disgnostic substances)
*** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request.
AMENDMENT NO. 4 TO DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT [ * ]Development and Manufacturing Services Agreement • February 27th, 2020 • Atara Biotherapeutics, Inc. • Biological products, (no disgnostic substances) • New York
This Amendment No. 4 to the Development and Manufacturing Services Agreement (“Fourth Amendment”) is made, entered into as of the date of last signature below (the “Execution Date”), and effective as of October 1, 2019 (the “Fourth Amendment Effective Date”) by and between ATARA BIOTHERAPEUTICS, INC., a Delaware corporation with offices at 611 Gateway Boulevard, Suite 900, South San Francisco, California 94080 (“Atara”); and COGNATE BIOSERVICES INC., a Delaware corporation with offices at 4600 East Shelby Drive, Suite 108, Memphis, TN 38118 (“Manufacturer”). Each of Atara and Manufacturer are referred to in this Fourth Amendment as a “Party” and together, the “Parties.” All capitalized terms used, but not otherwise defined herein, shall have the same meaning ascribed to them in the Services Agreement (as defined below).
DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENTDevelopment and Manufacturing Services Agreement • August 1st, 2018 • Atara Biotherapeutics, Inc. • Biological products, (no disgnostic substances) • New York
THIS DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT is made as of August 10, 2015 (the “Effective Date”) by and between ATARA BIOTHERAPEUTICS, INC, a Delaware corporation with an office at 701 Gateway Blvd, Suite 200, South San Francisco, CA 94080 (“Atara”) and COGNATE BIOSERVICES, INC., a Delaware corporation, with an office at 7513 Connelly Drive, Suite I, Hanover, MD 21076 (“Manufacturer”).
A request for confidential treatment has been made with respect to portions of the following document that are marked with [*]. The redacted portions have been filed separately with the SEC. DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENTDevelopment and Manufacturing Services Agreement • April 27th, 2015 • Anterios Inc • Pharmaceutical preparations • New York
THIS DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT is made and entered into as of August 17, 2011 (the “Effective Date”) by and between Anterios, Inc., a Delaware corporation having an address at 142 West 57th (Suite 4A), New York, NY 10019, (“Anterios”) and QuaDPharma, a New York corporation having an address at 11342 Main St., Clarence, New York, 14031 (“Manufacturer”).
AMENDMENT NO. 7 to the DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT dated 6th September 2017 between LONZA SALES AG and LONZA AG and DENALI THERAPEUTICS INC.Development and Manufacturing Services Agreement • February 27th, 2023 • Denali Therapeutics Inc. • Biological products, (no disgnostic substances)
AMENDMENT NO. 4 TO DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENTDevelopment and Manufacturing Services Agreement • May 5th, 2016 • Radius Health, Inc. • Pharmaceutical preparations • New York
This Amendment No. 4 (the “Amendment”) to the DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT is entered into on March 31, 2016 by and between Radius Health Inc., a Delaware corporation, with its principal office at 950 Winter Street, Waltham, MA 02451, United States of America (“RADIUS”) and LONZA Sales Ltd, a Swiss company having an address at Muenchensteinerstrasse 38, CH-4002 Basel, Switzerland (together with its Affiliates, “Manufacturer”) and upon execution will be incorporated into the Development and Manufacturing Services Agreement between RADIUS and Manufacturer dated October 16, 2007 (the “Original Agreement”), as amended to date. Capitalized terms used in this Amendment will have the same meaning as set forth in the Agreement as amended to date.
DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENTDevelopment and Manufacturing Services Agreement • December 27th, 2018 • Harpoon Therapeutics, Inc. • Biological products, (no disgnostic substances) • New York
This agreement is made as of July 5, 2016 (“Effective Date”) between CMC ICOS BIOLOGICS, INC., a Washington corporation (“CMC”), and HARPOON THERAPEUTICS, INC., a Delaware corporation (“Customer”).
AMENDMENT NO. 3 TO DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENTDevelopment and Manufacturing Services Agreement • November 7th, 2019 • Atara Biotherapeutics, Inc. • Biological products, (no disgnostic substances) • New York
This Amendment No. 3 to the Development and Manufacturing Services Agreement (“Third Amendment”) is made and entered into as of the date of last signature below (the “Execution Date”), but effective as of June 28, 2019 (the “Third Amendment Effective Date”) by and between ATARA BIOTHERAPEUTICS, INC., a Delaware corporation with offices at 611 Gateway Boulevard, Suite 900, South San Francisco, California 94080 (“Atara”); and COGNATE BIOSERVICES INC., a Delaware corporation with offices at 4600 East Shelby Drive, Suite 108, Memphis, TN 38118 (“Manufacturer”). Each of Atara and Manufacturer are referred to in this Third Amendment as a “Party” and together, the “Parties.” All capitalized terms used, but not otherwise defined herein, shall have the same meaning ascribed to them in the Services Agreement (as defined below).
DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENTDevelopment and Manufacturing Services Agreement • August 13th, 2014 • Omni Bio Pharmaceutical, Inc. • Biological products, (no disgnostic substances) • New York
This DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT, effective as of this __ day of ___________, 2014 (the “Effective Date”), between, Omni Bio Pharmaceutical, Inc., a Colorado corporation (“Customer”), having its principal place of business at 5350 S. Roslyn Street, Suite 430 Greenwood Village, CO 80111 and Gallus Biopharmaceuticals, LLC, a Delaware limited liability company with offices at 4766 LaGuardia Drive, St. Louis, MO 63134 (“Gallus”). Customer and Gallus are referred to herein each as a “Party” and collectively as the “Parties”.
ContractDevelopment and Manufacturing Services Agreement • November 8th, 2018 • Denali Therapeutics Inc. • Biological products, (no disgnostic substances)
SPECIFIC TERMS IN THIS EXHIBIT HAVE BEEN REDACTED BECAUSE CONFIDENTIAL TREATMENT FOR THOSE TERMS HAS BEEN REQUESTED. THE REDACTED MATERIAL HAS BEEN SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION, AND THE TERMS HAVE BEEN MARKED AT THE APPROPRIATE PLACE WITH THREE ASTERISKS [***].
DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENTDevelopment and Manufacturing Services Agreement • November 14th, 2016 • Asterias Biotherapeutics, Inc. • Biological products, (no disgnostic substances) • Delaware
THIS STATEMENT OF WORK (this “SOW 2”) is by and between ASTERIAS BIOTHERAPEUTICS, INC. (“Asterias”) and COGNATE BIOSERVICES, INC. (“Cognate”), will be effective as of the last date of signature below, and upon execution will be incorporated into the Development and Manufacturing Services Agreement between Asterias and Cognate dated August 3, 2016 (the “Agreement”). Capitalized terms used in this SOW 2 that are not otherwise defined herein (including service items defined in the tables set forth in this SOW 2) will have the same meanings as set forth in the Agreement.
Certain identified information has been omitted from this exhibit because it is both (i) not material and (ii) would likely cause competitive harm to the Registrant if publicly disclosed. Such omitted information is indicated by brackets...Development and Manufacturing Services Agreement • August 20th, 2021 • Amplitude Healthcare Acquisition Corp • Biological products, (no disgnostic substances) • New York
WHEREAS, Customer is engaged in the development and research of certain products and requires assistance in the development and manufacture of a certain product;
