EXHIBIT 10.13 Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote omissions. MANUFACTURING AGREEMENT This MANUFACTURING AGREEMENT (this "AGREEMENT") dated as of the first day of January,...Quality Agreement • June 10th, 2008 • Xanodyne Pharmaceuticals Inc • Pharmaceutical preparations • Ohio
Contract Type FiledJune 10th, 2008 Company Industry Jurisdiction
CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING...Quality Agreement • May 24th, 2019 • Akero Therapeutics, Inc. • Pharmaceutical preparations • New York
Contract Type FiledMay 24th, 2019 Company Industry JurisdictionThis EXCLUSIVE LICENSE AGREEMENT (this “Agreement”) is entered into as of June 7, 2018 (the “Effective Date”) by and between AMGEN INC., a Delaware corporation having an address at One Amgen Center Drive, Thousand Oaks, California 91320 (“AMGEN”), and AKERO THERAPEUTICS, INC., a Delaware corporation having an address at 271 Waverly Oaks, Suite 104, Waltham, Massachusetts 02452 (“AKERO”). AKERO and AMGEN are sometimes referred to herein individually as a “Party” and collectively as the “Parties”.
Sales, Marketing, Distribution, and Supply Agreement {***}Quality Agreement • May 5th, 2020 • Delaware
Contract Type FiledMay 5th, 2020 JurisdictionWHEREAS HEMISPHERX is a biopharmaceutical company with headquarters at One Penn Center, 1617 JFK Boulevard, Suite 500, Philadelphia, PA 19103, U.S. ("HEMISPHERX") and Scientific Products Pharmaceutical Co. LTD is a pharmaceutical company with its primary offices located at Tahlia Street, P.O Box 10485, Riyadh 11433 Saudi Arabia (" SCIEN”), each a “Party” together, “Parties”, and
ContractQuality Agreement • December 20th, 2013 • Eagle Pharmaceuticals, Inc. • Pharmaceutical preparations • England and Wales
Contract Type FiledDecember 20th, 2013 Company Industry Jurisdiction[*] = 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.
ZYDIS® DEVELOPMENT AND LICENSE AGREEMENT (Riluzole)Quality Agreement • April 24th, 2017 • Biohaven Pharmaceutical Holding Co Ltd. • Pharmaceutical preparations • Delaware
Contract Type FiledApril 24th, 2017 Company Industry JurisdictionThis Zydis® Development and License Agreement (“Agreement”) is made as of this 9th day of March, 2015 (“Effective Date”), by and between Biohaven Pharmaceutical Holding Company Ltd., a corporation duly formed under the laws of the British Virgin Islands (“Client”), and Catalent U.K. Swindon Zydis Limited, a company organized under the laws of Scotland (registered number SC070961), with a place of business at Frankland Road, Blagrove, Swindon, Wiltshire, UK SN5 8YG (“Catalent”) and Client are sometimes referred to in this Agreement as the “Parties” and individually as a “Party”.
Quality Agreement for CGMP Testing ServicesQuality Agreement • January 24th, 2019
Contract Type FiledJanuary 24th, 2019The Purpose of this Quality Agreement is to establish, clarify, and communicate quality expectations related to CGMP testing. This agreement shall apply to all samples submitted for testing. It is the responsibility of the Client to inform NJ LABS, utilizing the NJ LABS sample submission form, and by contacting NJ LABS’s Business Development group, of any special testing requirements. When samples are submitted to NJ LABS, they are designated as CGMP. This Agreement shall remain in effect until cancelled with notice by either party.
EXHIBIT AQuality Agreement • June 2nd, 2021 • Missouri
Contract Type FiledJune 2nd, 2021 JurisdictionTHIS AGREEMENT is entered into by the Missouri Highways and Transportation Commission (hereinafter, "Commission") and St. Charles County (hereinafter, "County”).
EX-10.91 8 d276679dex1091.htm MANUFACTURING AND SUPPLY AGREEMENT Portions of this exhibit marked [*] are omitted and are requested to be treated confidentially. MANUFACTURING AND SUPPLY AGREEMENTQuality Agreement • May 5th, 2020
Contract Type FiledMay 5th, 2020
Manufacturing Services Agreement by and between Tercica Medica, Inc. And Cambrex Bio Science Baltimore, Inc.Quality Agreement • November 14th, 2003 • Tercica Inc • Pharmaceutical preparations • New York
Contract Type FiledNovember 14th, 2003 Company Industry Jurisdiction
DATED 5 FEBRUARY 2019 AMENDMENT AND RESTATEMENT AGREEMENT relating to an agreement for the purchase and sale of source plasma originally dated 28 December 2018Quality Agreement • April 23rd, 2019 • Grifols SA • Pharmaceutical preparations
Contract Type FiledApril 23rd, 2019 Company IndustryWith effect from the Effective Date, the Original PSA shall be amended and restated so that it shall be read and be construed for all purposes as set out in schedule 3 (Amended PSA) and such amendment and restatement shall be deemed to take retrospective effect from 28 December 2018.
SUPPLIER QUALITY AGREEMENTQuality Agreement • September 2nd, 2020
Contract Type FiledSeptember 2nd, 2020The purpose of this document is to describe the criteria for Supplier Performance Review and rating. The document also informs Suppliers and Subcontractors what standards the Suppliers are responsible to meet and how TTM monitors and controls Supplier Performance.
ContractQuality Agreement • December 15th, 2022
Contract Type FiledDecember 15th, 2022
QUALITY AGREEMENTQuality Agreement • April 12th, 2022
Contract Type FiledApril 12th, 2022
LICENSE, MANUFACTURING AND SUPPLY AGREEMENTQuality Agreement • April 29th, 2013 • Regado Biosciences Inc • Pharmaceutical preparations • California
Contract Type FiledApril 29th, 2013 Company Industry JurisdictionThis Agreement (“AGREEMENT”) is made and entered into December 22, 2006 (the “EFFECTIVE DATE”) by and between Nektar Therapeutics AL, Corporation, having its principal place of business at 490 Discovery Drive, Huntsville, AL 35806 (“NEKTAR AL”), and Regado Biosciences, Inc., having its principal place of business at 324 Blackwell Street, Suite 420, Durham, North Carolina 27701 (“COMPANY”). NEKTAR AL and COMPANY may be referred to herein individually as a “PARTY” and collectively as the “PARTIES.”
EX-10.25 4 dex1025.htm MANUFACTURING & SERVICE CONTRACT Manufacturing and Service Contract For Commercial and Developmental Products Targanta Therapeutics Corporation [*] = Portions of this exhibit have been omitted pursuant to a confidential...Quality Agreement • May 5th, 2020 • Delaware
Contract Type FiledMay 5th, 2020 JurisdictionThis Manufacturing and Service Contract for Commercial and Developmental Products (hereinafter this “Agreement”) is made effective as of August 22, 2008 (the “Effective Date”), by Ben Venue Laboratories, Inc., a corporation organized and existing under the laws of Delaware, with its principal office at 300 Northfield Road, Bedford, Ohio 44146 (hereinafter “BVL”) and Targanta Therapeutics Corporation, a corporation organized and existing under the laws of Delaware, with its principal place of business at 225 S. East Street, Indianapolis, IN 46202 (hereinafter “Customer”). BVL and Customer may be referred to in this Agreement jointly as the “Parties” or individually as a “Party.”
CONFIDENTIAL GPEx® DEVELOPMENT AND MANUFACTURING AGREEMENTQuality Agreement • July 9th, 2018 • Vaccinex, Inc. • Pharmaceutical preparations • New York
Contract Type FiledJuly 9th, 2018 Company Industry JurisdictionThis GPEx® Development and Manufacturing Agreement (“Agreement”) is made as of January 13, 2010 (“Effective Date”), by and between Vaccinex, Inc., a with a place of business at 1895 Mt. Hope Avenue, Rochester, NY 14620, USA (“Vaccinex”) and Catalent Pharma Solutions, LLC, a Delaware limited liability company, with a place of business at 14 Schoolhouse Road, Somerset, New Jersey 08873, USA (“Catalent”).
QUALITY AGREEMENT No. 014180-1NOHL-00Quality Agreement • July 7th, 2015 • Gensight Biologics • Biological products, (no disgnostic substances)
Contract Type FiledJuly 7th, 2015 Company IndustryThis quality agreement (the “Quality Agreement”) is made and entered into as of 10th June 2014, by and between GENETHON, a non-profit organization organized under the laws of France (SIRET: 40218752000018), with its principal place of business at 1bis, rue de l’Internationale, 91002 Evry Cedex, France (“GENETHON”), and GENSIGHT-BIOLOGICS SA, a corporation organized under the laws of France, registered with the Lyon Trade and Company Registry under number B 751 164 757 (SIRET: 75116475700013), with its principal place of business at 74 rue du Faubourg Saint Antoine, 75012 Paris, France (“GENSIGHT”), (each of GENSIGHT and GENETHON a “Party” individually and collectively the “Parties”).
DOHODA O ZAJIŠTĚNÍ KVALITY S DODAVATELEM SUPPLIER QUALITY AGREEMENTQuality Agreement • February 2nd, 2022
Contract Type FiledFebruary 2nd, 2022on the realization of joint quality management with the objective of quality assurance of product development, products and deliveries.
Assigned Capacity and Manufacturing Agreement (the “Agreement”)Quality Agreement • June 18th, 2018 • Forty Seven, Inc. • Pharmaceutical preparations • New York
Contract Type FiledJune 18th, 2018 Company Industry Jurisdiction[*] = 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.
Quality AgreementQuality Agreement • July 31st, 2019
Contract Type FiledJuly 31st, 2019
EX-10.75 3 dex1075.htm COMMERCIAL MANUFACTURING AGREEMENT [ * ] = Certain information on this document has been redacted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the...Quality Agreement • May 5th, 2020 • New York
Contract Type FiledMay 5th, 2020 JurisdictionThis Commercial Manufacturing Agreement (“Agreement”) is made as of this 10th day of September, 2009 (“Effective Date”), by and between InterMune, Inc., a Delaware corporation, with a place of business at 3280 Bayshore Blvd., Brisbane, CA 94005 (“Client”), and Catalent Pharma Solutions, LLC, a Delaware limited liability company with a place of business at 14 Schoolhouse Road, Somerset, New Jersey 08873 (“Catalent”).
QUALITY AGREEMENTQuality Agreement • February 11th, 2023
Contract Type FiledFebruary 11th, 2023
Quality Agreement TAV-Medical Ltd and PALTOP Ltd Revision 1Quality Agreement • October 5th, 2023 • Capstone Dental Pubco, Inc. • Dental equipment & supplies
Contract Type FiledOctober 5th, 2023 Company IndustryThis document defines the requirements that must be met by the Contract Manufacturer (CM) & Supplier ‘TAV-Medical’ (herby:“Tav) organization in the conduct of the applicable production activities related to the TAV-Medical & Paltop products. These requirements have been established by Paltop to fulfill all quality, regulatory, statutory, performance, safety, and effectiveness requirements specific to this medical product, and to fulfill Paltop responsibility as a medical device manufacturer.
MISSOURI HIGHWAYS AND TRANSPORTATION COMMISSION CONGESTION MITIGATION AND AIR QUALITY AGREEMENTQuality Agreement • April 13th, 2011
Contract Type FiledApril 13th, 2011THIS AGREEMENT is entered into by the Missouri Highways and Transportation Commission (hereinafter, "Commission") and (hereinafter, "City/County/Grantee").
This Quality Agreement is by and between ZF Steering Systems, LLC,Quality Agreement • February 23rd, 2018
Contract Type FiledFebruary 23rd, 2018
INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933,...Quality Agreement • May 24th, 2018 • Xeris Pharmaceuticals Inc • Pharmaceutical preparations
Contract Type FiledMay 24th, 2018 Company IndustryThe Parties wish to further define their individual and collective responsibilities as to the quality aspects of the Product or Service to ensure compliance with applicable current Good Manufacturing Practices (cGMPs), applicable regulatory submissions for the Product, applicable regulatory submissions for the Services, other applicable regulatory requirements, and XERIS s requirements as specified by XERIS (the “XERlS Requirements”).
Quality AgreementQuality Agreement • June 4th, 2024 • Catheter Precision, Inc. • Surgical & medical instruments & apparatus
Contract Type FiledJune 4th, 2024 Company Industry
Date: 29 October 2007 First Amended: 11 December 2008 Amended and Restated: 14 May 2009 LifeScan, Inc. Universal Biosensors Pty Ltd Universal Biosensors, Inc. Amended and Restated Master Services and Supply AgreementQuality Agreement • August 7th, 2009 • Universal Biosensors Inc • Surgical & medical instruments & apparatus • New York
Contract Type FiledAugust 7th, 2009 Company Industry JurisdictionUniversal Biosensors Pty Ltd ACN 098 234 309, a company incorporated in Victoria, Australia of 1 Corporate Avenue, Rowville, Victoria 3178, Australia (UBS)
QUALITY AGREEMENTQuality Agreement • March 8th, 2013
Contract Type FiledMarch 8th, 2013
QUALITY AGREEMENT – FONDERIA TARONIQuality Agreement • September 22nd, 2017
Contract Type FiledSeptember 22nd, 2017This procedure aims to successful manufacture of components and subassemblies provided by SUPPLIER and purchased by FONDERIA TARONI. The responsibility matrix below defines and deals with the necessary documentation and responsibilities.
Supplier Quality AgreementQuality Agreement • May 18th, 2020
Contract Type FiledMay 18th, 2020
Quality AgreementQuality Agreement • February 15th, 2013
Contract Type FiledFebruary 15th, 2013
Supplier Quality AgreementQuality Agreement • November 17th, 2015
Contract Type FiledNovember 17th, 2015
DRUG PRODUCT MANUFACTURING SERVICES AGREEMENTQuality Agreement • November 9th, 2017 • Depomed Inc • Pharmaceutical preparations • New York
Contract Type FiledNovember 9th, 2017 Company Industry JurisdictionTHIS DRUG PRODUCT MANUFACTURING SERVICES AGREEMENT (this “Agreement”) is effective as of June 6, 2017 (the “Effective Date”) by and between Halo Pharmaceutical, Inc., a Delaware corporation (“Halo”), and Depomed, Inc., a California corporation (“Client”).
Quality Agreement for CGMP Testing ServicesQuality Agreement • July 26th, 2023
Contract Type FiledJuly 26th, 2023The Purpose of this Quality Agreement is to establish, clarify, and communicate quality expectations related to CGMP testing. This agreement shall apply to all samples submitted for testing. It is the responsibility of the Client to inform NJ LABS, utilizing the NJ LABS sample submission form, and by contacting NJ LABS 's Business Development group, of any special testing requirements. When samples are submitted to NJ LABS, they are designated as CGMP. This Agreement shall remain in effect until cancelled with notice by either party.