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.
Quality Technical Agreement. Within sixty (60) days after the date of this Agreement, representatives of the parties’ Quality 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. 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. [*] = 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 24b-2 of the Securities Exchange Act of 1934, as amended.
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. Within [**] of the Effective Date, representatives of the Parties’ quality assurance departments shall meet to review and revise, if necessary, and execute the Quality Technical Agreement. The terms contained in the Quality Technical Agreement are intended to complement the terms of this Agreement, and they shall be interpreted as complementary to the extent possible. In the event of a conflict between the terms of the Quality Technical Agreement and the terms of this Agreement, the terms of this Agreement shall control with respect to business, financial and legal matters, and the terms of the Quality Technical Agreement shall control with respect to quality control and quality assurance matters related to the API (including, without limitation, Manufacturing, testing, storage, release, change management and validation activities); provided, however, that the inclusion of a particular term or level of detail in the Quality Technical Agreement where such term or level of detail is absent from this Agreement shall not be deemed to constitute a conflict between the two agreements. Only where competing terms in the two agreements conflict in terms of the principal focus of an express prescription or prohibition in the agreements shall a conflict between the two agreements be deemed to exist. Any material breach of the Quality Technical Agreement shall be deemed a breach of this Agreement.
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.
Quality Technical Agreement. Within [**] days after the date of this Agreement, representatives of the Parties’ Quality Assurance departments shall meet to review and revise, if necessary, the attached Quality Technical Agreement outlining responsibilities and key contacts for Key Intermediate quality and compliance related issues. SEL will provide NABRIVA 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 current Good Manufacturing Practices, and such other quality related concerns deemed appropriate.
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. Upon execution of this Agreement, the Parties will commence good faith negotiations of a Quality/Technical Agreement setting forth in greater detail the regulatory and quality assurance responsibilities of the Parties with regard to the Manufacture of Product and further providing for compliance with Regulatory Requirements. Each of the Parties will exercise Commercially Reasonable Efforts to finalize and execute such agreement within 90 days after the Effective Date. *** Indicates the omission of confidential material pursuant to a request for confidential treatment made in accordance with Rule 24b-2 under the Securities Exchange Act of 1934, as amended. The Confidential material is being filed separately with the Secretary to the Securities and Exchange Commission.
