Quality Technical Agreement Sample Clauses

Quality Technical Agreement. In addition, the Parties shall negotiate and execute a Quality/Technical Agreement as further detailed in Section 5.1(b) of the Supply Agreement.
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Quality Technical Agreement. Within sixty (60) days after the date of this Agreement, representatives of the partiesQuality Assurance departments shall meet to develop, agree and approve a Quality Technical Agreement outlining responsibilities and key contacts for quality and compliance related issues. [MANUFACTURER] will provide PURCHASER with certain production and control information for review prior to release as specified in the Quality Technical Agreement. The Quality Technical Agreement will also address, without limitation, annual product reviews, returned goods, regulatory audits, compliance with FDA cGMPs, and such other quality related concerns deemed appropriate.
Quality Technical Agreement. Lexicon shall use Diligent Efforts to manufacture or have manufactured the Licensed Product in accordance with the product specifications and in accordance with cGMP and as set forth in a quality agreement, which shall be entered into between the Parties within [**] of the Effective Date. The quality agreement will set out the responsibility of the Parties in connection with the Licensed Products as related to quality control, quality assurance and change control (“Quality Technical Agreement”).
Quality Technical Agreement. Within sixty (60) days after the Effective Date, the Parties shall enter into a Quality Technical Agreement outlining responsibilities and key contacts for API quality and compliance related issues. Helsinn will provide Indevus with certain production and control information for review prior to release as specified in the Quality Technical Agreement. The Quality Technical Agreement will also address, without limitation, annual product reviews, returned goods, regulatory audits, compliance with Current Good Manufacturing Practices, and such other quality related concerns deemed appropriate. The final agreed Quality Technical Agreement will be attached to this Agreement as Exhibit 1.22 and deemed a part of this Agreement. In the event that the Quality Technical Agreement contains material provisions that substantially differ from applicable comparable Regulatory Standards, the Regulatory Standards shall control.
Quality Technical Agreement. The Parties will use all commercially reasonable efforts to negotiate and conclude a Quality & Technical Agreement which will be attached hereto as Schedule 7.2 no later than [*] days after the Effective Date, but in any case prior to any cGMP manufacture of the Product.
Quality Technical Agreement. As soon as practicable after the Effective Date, the Parties hereby agree to negotiate in good faith the execution of a Quality/Technical Agreement. Such Quality/Technical Agreement shall be mutually agreed to in writing prior to placement of any Purchase Order for the Product.
Quality Technical Agreement. The Parties have entered into a Quality Technical Agreement as attached hereto as Exhibit 10.2. Authorized personnel of the Parties may amend [**] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. provisions of the Quality Technical Agreement by mutual agreement in writing, without formal amendment to this Master Agreement.
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Quality Technical Agreement. Upon the request of either Party, and in any event at least six (6) months prior to the Anticipated Launch Date, the Parties shall enter into an amended Quality Technical Agreement that will cover the commercial supply of API. Upon execution, such amended Quality Technical Agreement shall be deemed to be attached to and incorporated into the Agreement as Exhibit 3.5. Without limiting the foregoing requirements, GEMA’s quality assurance and quality control practices shall be at least as stringent as those practices as are standard in the pharmaceutical manufacturing industry. The Quality Technical Agreement is not intended and shall not be construed to limit any of the rights and obligations of the Parties set forth in this Agreement. Subject to the foregoing, to the extent possible, the Quality Technical Agreement will be interpreted with the terms set forth in the body of this Agreement. If there is any conflict or inconsistency between the terms of the Quality Technical Agreement and the terms set forth in this Agreement, however, the terms set forth in this Agreement shall control.
Quality Technical Agreement. Xxxxxxxxx-Xxxxx shall obtain Auxilium’s written approval when preparing responses to Regulatory Agencies, when the responses are directly related to the Products. Xxxxxxxxx-Xxxxx will promptly notify Auxilium of any regulatory action resulting in:
Quality Technical Agreement. Xxxxxxxxx-Xxxxx will provide personnel qualified and trained to perform and supervise operations related to the Product. Xxxxxxxxx-Xxxxx will also provide written job descriptions for positions responsible for processing the Product.
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