Manufacture and Supply by MKG Sample Clauses

Manufacture and Supply by MKG. Promptly after execution of this Agreement, MKG shall begin making preparations necessary to ensure that sufficient quantities of the Licensed Compound are available to conduct Phase III trials and complete validation of the manufacturing process of the Licensed Products on schedule. Upon completion of Phase II trials of the Licensed Compound and any Second Generation Compounds, any Replacement Compounds or any Outside Compounds, as applicable, MKG shall become responsible for (i) manufacturing the respective Licensed Products at the required quality and in quantities sufficient for development of the Licensed Compound and any Second Generation Compounds, Replacement Compounds or Outside Compounds, as applicable, after completion of Phase II trials thereof, including validation batches, and for commercial sale of the respective Licensed Products in the Territory, (ii) providing documentation, other than that provided by Metasyn, regarding the manufacture of the respective Licensed Products needed to register such Licensed Products in the Territory and to sell the respective Licensed Products under the relevant governmental approval in the Territory and (iii) arranging for pre-approval and/or routine establishment inspections with respect to the respective Licensed Products made by MKG. In the event that MKG designates a Third Party manufacturer, it shall enter into a reasonable confidentiality agreement with such manufacturer, such agreement to be subject to the approval of the Joint Steering Committee.
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Manufacture and Supply by MKG. Promptly after execution of this Agreement, MKG shall begin making preparations necessary to meet its obligations under the Manufacturing Agreement and shall comply with its obligations thereunder during the term of this Agreement. * Confidential information omitted and filed with the Commission.
Sample 1

Related to Manufacture and Supply by MKG

  • Manufacture and Supply BMS shall Manufacture or have Manufactured the BMS Study Drug in reasonable quantities needed, and at the points in time as agreed to by the Parties, for the Combined Therapy Clinical Trial, and shall supply such BMS Study Drug as either commercially labeled or unlabeled vials to the Recipient or its designee for use solely in the Combined Therapy Clinical Trial. The Recipient will at its sole expense, package and label the BMS Study Drug for use in the Combined Therapy Clinical Trial to the extent necessary. The cost of Manufacture and supply (including shipping, taxes and duty, if applicable) of the BMS Study Drug for the Combined Therapy Clinical Trial shall be borne solely by BMS, and BMS shall bear the risk of loss for such quantities of BMS Study Drug until delivery of such quantities of BMS Study Drug to the Recipient or its designee. BMS shall also be responsible for the payment of any Third Party License Payments that may be due based on the manufacture, *CONFIDENTIAL TREATMENT REQUESTED. supply and use of the BMS Study Drug used in the Combined Therapy Clinical Trial. The BMS Study Drug shall be manufactured in accordance with Applicable Law (including GMP) and shall be of similar quality to the BMS Study Drug used by BMS for its other clinical trials of the BMS Study Drug. BMS shall deliver certificates of analysis, and any other documents specified in the Supply and Quality Documentation, including such documentation as is necessary to allow the Recipient to compare the BMS Study Drug certificate of analysis to the BMS Study Drug specifications. Pursuant to the Supply and Quality Documentation, BMS shall be responsible for the regulatory compliance of the quality of the BMS Study Drug at the time the BMS Study Drug is delivered to the Recipient with the regulatory filings in the countries in the Territory where the Combined Therapy Clinical Trial will be performed. Subject to Section 4.4, the Parties shall cooperate in accordance with Applicable Law to minimize indirect taxes (such as value added tax, sales tax, consumption tax and other similar taxes) relating to the BMS Study Drug in connection with this Agreement.

  • Supply Agreement Buyer shall have executed and delivered the Supply Agreement to the Company.

  • Supply Agreements For a period of three years from the consummation of the IPO, Odetics shall not unilaterally terminate or assign its guarantee obligation with respect to any supply agreement pursuant to which it has guaranteed the performance by ATL of ATL's obligations, unless such suppliers have consented to the termination or assignment of such guarantee.

  • Supply of Products TheraSense shall be responsible for the ------------------ manufacture of FreeStyle Products for sale to Nipro.

  • Manufacturing and Supply Genentech shall be responsible for manufacturing and supplying Licensed Products for clinical use and commercial sale in the Genentech Field.

  • Manufacture of Products All Products marketed through Grantor's Web ------------------------- Site shall be manufactured, packaged, prepared, and shipped in accordance with the specifications and requirements described on Exhibit A hereto as it may be modified from time to time. Quality control standards relating to the Product's weight, color, consistency, micro-biological content, labeling and packaging are also set forth on Exhibit A. In the event that Exhibit A is incomplete, Products shall be manufactured and shipped in accordance with industry standards.

  • Manufacturing Agreement Each of the Sellers (as applicable) shall have executed and delivered to the Buyer the Manufacturing Agreement with respect to the portion of the Business conducted at the applicable Facility.

  • Supply of Product The JDC shall be responsible for determining the sources of, and arrangements for, the manufacture and supply of Products that the JDC believes will result in long-term profit maximization for such Products. The JDC shall endeavor to [ * ].

  • Manufacture of Product Prior to commercialization of the Product, the Parties may, if appropriate for both parties, negotiate in good faith a manufacturing and supply agreement to provide for Licensor to fulfill the manufacturing requirements of Licensee for Product for sale in the European market. The cost of such manufacturing shall not be greater than * percent (*%) of the cost of any competitor cGMP contract manufacturing facility that proposes to manufacturer the Product for Licensee. * Confidential information has been omitted and filed confidentially with the Securities and Exchange Commission.

  • Assignment and Sublicensing The rights and licenses granted hereunder may not be sublicensed, conveyed, assigned or otherwise transferred by Licensee to any third party without NCT Hearing's prior written consent in each instance. In addition, Licensee shall have the right to have Licensed Products manufactured for it by others but only after obtaining NCT Hearing's prior written consent and only under nondisclosure agreements implemented in accordance with the provisions of Articles 4 and 5 hereof.

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