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Document Preview Clinical Supply Agreement |
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Title: |
Clinical Supply Agreement |
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Date: |
2007 |
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$37 |
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ID: |
#2750867 |
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CLINICAL SUPPLY AGREEMENT
THIS CLINICAL SUPPLY AGREEMENT (the Agreement) is entered into as of the 1st day of June, 2006 (the Effective Date) by and between SCHERING AKTIENGESELLSCHAFT, a German corporation having a principal place of business at Mllerstrae 178, D-13342 Berlin, Germany (Schering) and SONUS PHARMACEUTICALS, INC., a Delaware corporation having a principal place of business at 22026 20th Avenue SE, Bothell, Washington 98021 (Sonus). Schering and Sonus are referred to individually as a Party and collectively as Parties.
WHEREAS, Schering and Sonus have entered into a Collaboration and License Agreement having an effective date of October 17, 2005 (the License Agreement) for the development and commercialization of the Product in the Territory (each as defined below);
WHEREAS, pursuant to the License Agreement, Sonus has granted to Schering exclusive rights to develop and commercialize the Product in the Territory, which rights include, among other rights, the right to elect to make the Product and have the Product made on its behalf;
WHEREAS, Schering gave written notice of its election to assume responsibility for manufacture and supply of Product on March 2, 2006, but has not yet established internal or external manufacturing capabilities for the Product, and the Parties desire that Sonus supply Schering with clinical supplies of the Product pursuant to the MSA (as defined below) until Schering establishes such manufacturing capabilities; and
WHEREAS, pursuant to Section 7.02 of the License Agreement, the Parties wish to provide for each Partys rights and responsibilities in connection with the clinical supply of the Product to Schering by Sonus as set forth in the terms and conditions of this Agreement.
NOW, THEREFORE, in consideration of the premises and the mutual covenants and agreements contained herein, the Parties agree as follows:
Capitalized terms used in this Agreement (other than the headings of the Articles and Sections), whether used in the singular or plural, shall have the meaning set forth below, or, if not listed below, the meaning as designated in the text of this Agreement.
Affiliate means, with respect to any Person, any other Person that directly or indirectly controls, is controlled by or is under common control with such Person. For the purposes of this definition, a Person shall be deemed to control another Person if such Person possesses the power to direct or cause the direction of the management, business and policies of such Person, whether through ownership of fifty percent (50%) or more of the voting securities of such Person, by contract or otherwise.
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body of man or animals, but does not include intermediates used in the synthesis of such ingredients.
Certificate of Analysis means a certificate that accompanies each shipment of Product certifying that the Product meets the Specifications.
Certificate of Compliance means a certificate that accompanies each shipment of Product certifying that the Product has been manufactured according to cGMP.
cGMP means current Good Manufacturing Practices regulations promulgated by FDA, as they may be amended from time to time. cGMP also includes published standards of FDA (or other standards of FDA that are generally recognized within the United States pharmaceutical industry) that relate to the testing, manufacturing, processing, packaging, holding or distribution of drug substances and finished drugs. cGMP also includes similar standards, guidelines and regulations promulgated or otherwise required by the European Commission, and published standards of the European Commission (and other standards of the European Commission that are generally recognized within the European pharmaceutical industry), including the Guide to Good Manufacturing Practices for Medicinal Products as promulgated under European Directive 91/356/EEC, as amended from time to time, that relate to the testing, manufacturing, processing, packaging, holding or distribution of drug substances and finished drugs..
Confidential Information means all information and materials regarded by the disclosing Party as confidential (including, without limitation, information relating to the Sonus Technology, as defined in the License Agreement) furnished by one Party to the other pursuant to this Agreement and all information created or developed during the course of the Parties collaboration hereunder, whether in oral, written, graphic or electronic form. Confidential Information shall not include any information which the receiving party can prove by competent evidence:
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