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 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. 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 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. 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. The Parties will also negotiate and enter into a separate quality technical agreement (“QTA”) within [*] of the Effective Date or otherwise agreed by both Parties. Pursuant to Section 6.6 (CMC and Quality Audit), within [*] of the Effective Date, Sutro shall allow Ipsen to conduct, at Xxxxx’x Cost, a GMP quality inspection of the Manufacturing site of Sutro and of each of Sutro’s CMO (solely if, and to the extent, permitted by Sutro’s contracts with its CMOs and subject to Sutro’s Commercially Reasonable Efforts) in which the Licensed Compound (excluding CFE) and the Licensed Product is Manufactured, stored and handled to assess compliance with GMP standard and applicable regulatory requirements; provided that Ipsen shall have no right to audit any information directed to CFE Technology or Manufacture of CFE.
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. 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. 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.
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.
