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
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
This 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”.
ContractQuality Agreement • December 20th, 2013 • Eagle Pharmaceuticals, Inc. • Pharmaceutical preparations • England and Wales
[*] = 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
This 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
The 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
THIS AGREEMENT is entered into by the Missouri Highways and Transportation Commission (hereinafter, "Commission") and St. Charles County (hereinafter, "County”).
Sales, Marketing, Distribution, and Supply Agreement {***}Quality Agreement • August 29th, 2016 • Hemispherx Biopharma Inc • Biological products, (no disgnostic substances) • Delaware
WHEREAS 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
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
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
With 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
The 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
LICENSE, MANUFACTURING AND SUPPLY AGREEMENTQuality Agreement • April 29th, 2013 • Regado Biosciences Inc • Pharmaceutical preparations • California
This 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.”
CONFIDENTIAL GPEx® DEVELOPMENT AND MANUFACTURING AGREEMENTQuality Agreement • July 9th, 2018 • Vaccinex, Inc. • Pharmaceutical preparations • New York
This 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)
This 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
on 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
[*] = 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
QUALITY AGREEMENTQuality Agreement • March 12th, 2021
Quality Agreement TAV-Medical Ltd and PALTOP Ltd Revision 1Quality Agreement • October 5th, 2023 • Capstone Dental Pubco, Inc. • Dental equipment & supplies
This 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
THIS 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
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
The 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”).
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
Universal 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
QUALITY AGREEMENT – FONDERIA TARONIQuality Agreement • September 22nd, 2017
This 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
Quality AgreementQuality Agreement • February 15th, 2013
Supplier Quality AgreementQuality Agreement • November 17th, 2015
DRUG PRODUCT MANUFACTURING SERVICES AGREEMENTQuality Agreement • November 9th, 2017 • Depomed Inc • Pharmaceutical preparations • New York
THIS 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
The 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.
Quality AgreementQuality Agreement • March 12th, 2018
The Purpose of this Quality Agreement is to establish, clarify, and communicate quality expectations related to cGMP testing. This agreement shall apply exclusively to samples submitted for testing that must be tested in compliance with cGMP guidelines. It is the responsibility of the Client to inform ARL, utilizing the ARL sample submission form, and by contacting ARL’s Business Development group, if the requested testing is to be conducted per cGMP guidelines. When samples are submitted to ARL and designated as cGMP and a quote is in place that indicates cGMP testing requirements, than the testing will be conducted under cGMP conditions. This Agreement shall remain in effect until cancelled with notice by either party.
Distributor/Importer Quality Agreement Under In Vitro Diagnostic Medical Device Regulation (EU) 2017/746Quality Agreement • December 19th, 2019
This agreement defines the Quality Agreement between the parties identified below. It defines the commitment both parties make to ensure that their respective products and services satisfy the quality and regulatory requirements called out in this agreement. Both parties agree to cooperate in the success of this agreement.
SUPPLIER QUALITY AGREEMENTQuality Agreement • August 5th, 2020
ContractQuality Agreement • August 6th, 2019
FALK2016年12月23日发来稿注册部审核部分Quality Agreement • December 27th, 2016
1、API: means any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in the production of a medicinal product, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.
