Development and Manufacturing Services Agreement Sample Contracts
THE DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT Dated 08 January 2004Development and Manufacturing Services Agreement • September 22nd, 2006 • Trubion Pharmaceuticals, Inc • Pharmaceutical preparations
EX-10.7 9 a2233117zex-10_7.htm EX-10.7 Execution Version DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENTDevelopment and Manufacturing Services Agreement • May 5th, 2020 • 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 Agreement (the “Agreement”)Development and Manufacturing Services Agreement • February 27th, 2023 • 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;
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”).
EX-10.15 14 a2233117zex-10_15.htm EX-10.15 DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENTDevelopment and Manufacturing Services Agreement • May 5th, 2020 • 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”).
EX-10.3 4 d98735dex103.htm EX-10.3 AMENDED AND RESTATED DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENTDevelopment and Manufacturing Services Agreement • May 5th, 2020 • Massachusetts
THIS AMENDED AND RESTATED DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT is made and entered into effective as of July 6, 2015 (the “Effective Date”) by and between Alnylam Pharmaceuticals, Inc., a Delaware corporation having an address at 300 Third Street, Third Floor, Cambridge, Massachusetts 02142 (together with its Affiliates, “Alnylam”) and Agilent Technologies, Inc., a Delaware corporation having an address at 5555 Airport Blvd, Suite 100, Boulder CO 80301 (“Manufacturer”).
CONFIDENTIAL TREATMENT REQUESTED DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENTDevelopment and Manufacturing Services Agreement • August 12th, 2015 • Mabvax Therapeutics Holdings, Inc. • Pharmaceutical preparations • New York
This DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT, effective as of this 15th day of April 2014 (the “Effective Date”), between, MabVax Therapeutics, a Delaware Corporation (“Customer”), having its principal place of business at 11588 Sorrento Valley Road, Suite 20, San Diego CA 92121, and Gallus Biopharmaceuticals NJ, LLC, a Delaware limited liability company with offices at 201 College Road East, Princeton, NJ 08540 (“Gallus”). Customer and Gallus are referred to herein each 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 • 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”).
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM IF PUBLICLY DISCLOSED. Lonza Ltd Münchensteinerstrasse 38 CH-4002 Basel...Development and Manufacturing Services Agreement • May 22nd, 2020 • Vaxcyte, Inc. • Biological products, (no disgnostic substances)
As you know, Lonza Ltd (“Lonza”) and SutroVax, Inc (“SutroVax” or “Customer”) are parties to the Development and Manufacturing Services Agreement, dated October 21, 2016, between Lonza and SutroVax and as amended on January 1, 2017, July 1, 2017 and September 26, 2017 (the “2016 Agreement”), under which Lonza is providing development and manufacturing services to SutroVax in connection with SutroVax’s multi-valent pneumococcal vaccine product. In addition, as of the date of this letter, SutroVax and Lonza are in negotiations of a new Development and Manufacturing Services Agreement, which, if entered into, will govern the terms and conditions under which Lonza will provide SutroVax with development and manufacturing services for such vaccine product in drug product form (the “2018 Agreement”). The 2016 Agreement, the 2018 Agreement, and any future written addendums and agreements entered into between SutroVax and Lonza relating to SutroVax’s engagement of Lonza’s services for SutroVax’
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 Agreement (the “Agreement”)Development and Manufacturing Services Agreement • May 22nd, 2020 • 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;
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”).
WORK ORDER NO. 2*Development and Manufacturing Services Agreement • November 8th, 2011 • Radius Health, Inc. • Blank checks
THIS WORK ORDER NO. 2 is by and between RADIUS HEALTH, INC. (“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 “Agreement”). Capitalized terms in this Work Order will have the same meanings as set forth in the Agreement.
DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENTDevelopment and Manufacturing Services Agreement • September 13th, 2024 • Bluebird Bio, Inc. • Biological products, (no disgnostic substances) • New York
THIS DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT is made as of February 28, 2012 (the “Effective Date”) by and between bluebird bio, Inc., a Delaware corporation with an office at 840 Memorial Drive, Cambridge, MA 02139 (“bluebird bio”) and Progenitor Cell Therapy, LLC, a Delaware limited liability company with an office at 4 Pearl Court, Suite C, Allendale, New Jersey 07401 (“Manufacturer”).
Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(b)(4) and 240-24b-2 WORK ORDER NO. 11Development and Manufacturing Services Agreement • November 5th, 2015 • Radius Health, Inc. • Pharmaceutical preparations
THIS WORK ORDER NO. 11 is by and between RADIUS HEALTH, INC. (“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 “Agreement”). Capitalized terms in this Work Order will have the same meanings as set forth in the Agreement.
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”).
CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[***]”. SUCH IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) THE TYPE OF INFORMATION THAT THE REGISTRANT TREATS AS...Development and Manufacturing Services Agreement • August 7th, 2025 • Cabaletta Bio, Inc. • 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 such products;
Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(b)(4) and 240-24b-2 WORK ORDER NO. 12Development and Manufacturing Services Agreement • November 5th, 2015 • Radius Health, Inc. • Pharmaceutical preparations
THIS WORK ORDER NO. 12 is by and between RADIUS HEALTH, INC. (“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 “Agreement”). Capitalized terms in this Work Order will have the same meanings as set forth in the Agreement.
WORK ORDER NO. 4Development and Manufacturing Services Agreement • May 5th, 2016 • Radius Health, Inc. • Pharmaceutical preparations
THIS WORK ORDER NO. 4 is by and between RADIUS HEALTH, INC. (“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 “Agreement”). Capitalized terms in this Work Order will have the same meanings as set forth in the Agreement.
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”).
ContractDevelopment and Manufacturing Services Agreement • August 3rd, 2020 • Rhythm Pharmaceuticals, Inc. • Pharmaceutical preparations
Certain information marked as [***] has been excluded from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
WORK ORDER NO. 13Development and Manufacturing Services Agreement • May 5th, 2016 • Radius Health, Inc. • Pharmaceutical preparations
THIS WORK ORDER NO. 13 is by and between RADIUS HEALTH, INC. (“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 “Agreement”). Capitalized terms in this Work Order will have the same meanings as set forth in the Agreement.
ContractDevelopment and Manufacturing Services Agreement • August 20th, 2021 • Amplitude Healthcare Acquisition Corp • Biological products, (no disgnostic substances)
*** 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 (“[...***...]”) in this exhibit. ***
ContractDevelopment and Manufacturing Services Agreement • May 5th, 2020 • New York
EX-10.6 7 ex10-6.htm DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT, DATED APRIL 15, 2014, BY AND BETWEEN MABVAX THERAPEUTICS, INC. AND GALLUS BIOPHARMACEUTICALS NJ, LLC Exhibit 10.6 CONFIDENTIAL TREATMENT REQUESTED DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT This DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT, effective as of this 15th day of April 2014 (the “Effective Date”), between, MabVax Therapeutics, a Delaware Corporation (“Customer”), having its principal place of business at 11588 Sorrento Valley Road, Suite 20, San Diego CA 92121, and Gallus Biopharmaceuticals NJ, LLC, a Delaware limited liability company with offices at 201 College Road East, Princeton, NJ 08540 (“Gallus”). Customer and Gallus are referred to herein each as a “Party” and collectively as the “Parties”. WHEREAS, Gallus provides a full range of manufacturing and bioprocessing services to the biopharmaceutical industry, including cell line development, process development, protein production, cell cult
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)
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 [***].
Confidential Treatment Requested Under 17 C.F.R. §§ 200.80(b)(4) and 240-24b-2 WORK ORDER NO. 10Development and Manufacturing Services Agreement • August 6th, 2015 • Radius Health, Inc. • Pharmaceutical preparations
THIS WORK ORDER NO. 10 is by and between RADIUS HEALTH, INC. (“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 “Agreement”). Capitalized terms in this Work Order will have the same meanings as set forth in the Agreement.
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.
AMENDED AND RESTATED DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENTDevelopment and Manufacturing Services Agreement • March 20th, 2025 • Senti Biosciences, Inc. • Biological products, (no disgnostic substances) • Delaware
(this “Agreement”) is made as of December 10, 2024 (the “Effective Date”) by and between GeneFab, LLC, a Delaware limited company (“Provider”), with offices at 1430 Harbor Bay Parkway, 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.”