QA Agreement Clause Samples

POPULAR SAMPLE Copied 5 times
QA Agreement. The Parties shall enter into a separate QA Agreement, in the agreed form attached at Exhibit B to this Agreement, relating to the Parties’ QA responsibilities and in particular addressing the following (but without limitation): documents, records, samples, change management and approval, inspections, complaints, recalls, testing and release.
View SourceView Similar (3)
QA Agreement. The parties hereto shall as soon as reasonably possible after execution hereof execute a Quality Assurance Agreement specifying the pharmaceutical rules and procedures applicable to the supply of Product hereunder. The terms of this Agreement shall prevail over any conflicting terms contained in such Quality Assurance Agreement. Such Quality Assurance Agreement may be updated, or superseded by a new version thereof, at all reasonable times by mutual agreement.
View Source
QA Agreement. Avecia will carry out the work as detailed in the Programme in accordance with the terms of the QA Agreement. In order for Avecia to carry out the Programme, each party shall fulfil its responsibilities as set out in the QA Agreement.
View SourceView Similar (2)
QA Agreement. Within sixty (60) days from the Effective Date, the Parties shall negotiate in good faith and execute a QA Agreement in connection with this Agreement (the “QA Agreement”) which addresses the management of the quality elements related to the Product. In the event of any conflict between the terms of this Agreement and the QA Agreement, this Agreement shall prevail.
View Source

Related to QA Agreement

  • Collaboration Agreement The Collaboration Agreement shall not have been terminated in accordance with its terms and shall be in full force and effect.

  • Quality Agreement Concurrently with execution of this Agreement, the Parties will enter into an agreement that details the quality assurance obligations of each Party with respect to the Manufacture and supply of Supplied Products under this Agreement (the “Quality Agreement”). Each Party shall perform its obligations under the Quality Agreement in accordance with the terms and conditions thereof. In the event of a conflict between the terms of the Quality Agreement and the terms of this Agreement, the provisions of the Quality Agreement shall govern.

  • Supply Agreement Until the Parties enter into the Supply Agreement, the Parties agree to the following terms, which terms, to the extent applicable, shall be included in the Supply Agreement: 5.1. Pro-Dex will be Monogram’s exclusive manufacturer and supplier for all of the Products. Before providing any manufacturing and supply services to Monogram, Pro-Dex will provide in writing to Monogram: (i) the reference data (from simulated use studies) used to inform the warranty period; (ii) the framework for validating processes for receiving contaminated field units for repairs and servicing; (iii) the price per Product, which, subject to Section 5.3, if Monogram does not agree to, shall be determined by Monogram soliciting bids for that same Product from at least three manufacturing companies that are (a) mutually agreed upon by Monogram and Pro-Dex, (b) ISO 13485 qualified, (c) registered with the FDA, and (d) in compliance with the FDA’s Quality System Regulation (the “Qualified Manufacturers”). The higher of (x) the average of the bids provided by the Qualified Manufacturers and (y) the median of the bids shall be the “Qualified Manufacturer Bid”. After obtaining the Qualified Manufacturer Bid, Pro-Dex will have the right to manufacture and supply that Product at the lesser of (i) one hundred and fifty percent (150%) of the Qualified Manufacturer Bid or (ii) the original bid submitted by Pro-Dex. If Pro-Dex does not elect to manufacture and supply that Product on such terms, Monogram may outsource the manufacturing and supply of that Product to a Qualified Manufacturer selected by Monogram and subject to Pro-Dex’s approval (not to be unreasonably withheld); and (iv) the lead time required by Pro-Dex to deliver the manufactured Products to Monogram, which, if Monogram does not agree to, shall be determined by Monogram soliciting lead time bids for that same Product from at least three Qualified Manufacturers. The higher of (x) the average of the bids provided by the Qualified Manufacturers and (y) the median of the bids shall be the “Qualified Lead Time Bid”. After obtaining the Qualified Lead Time Bid, Pro-Dex will have the right to supply the Products with a lead time equal to the lesser of (i) two hundred percent (200%) of the Qualified Lead Time Bid or (ii) the original bid submitted by Pro-Dex. If Pro-Dex does not elect to manufacture and supply that Product at such lead times, Monogram may outsource the manufacturing and supply of that Product to a Qualified Manufacturer selected by Monogram and subject to Pro-Dex’s approval (not to be unreasonably withheld).

  • Pharmacovigilance Agreement Subject to the terms of this Agreement, and at a date to be determined by the JDC, Facet and Trubion shall define and finalize the actions the Parties shall employ to protect patients and promote their well-being in a written agreement (hereinafter referred to as the “Pharmacovigilance Agreement”). These responsibilities shall include mutually acceptable guidelines and procedures for the receipt, investigation, recordation, communication, and exchange (as between the Parties) of adverse event reports, pregnancy reports, and any other information concerning the safety of any Collaboration Product. Such guidelines and procedures shall be in accordance with, and enable the Parties to fulfill, local and national regulatory reporting obligations to Governmental Authorities. Furthermore, such agreed procedures shall be consistent with relevant ICH guidelines, except where said guidelines may conflict with existing local regulatory safety reporting requirements, in which case local reporting requirements shall prevail. The Pharmacovigilance Agreement will provide for a worldwide safety database to be maintained by the Party appointed by the JDC. Each Party hereby agrees to comply with its respective obligations under such Pharmacovigilance Agreement (as the Parties may agree to modify it from time to time) and to cause its Affiliates and permitted sublicensees to comply with such obligations.

  • License Agreement The Trust shall have the non-exclusive right to use the name "Invesco" to designate any current or future series of shares only so long as Invesco Advisers, Inc. serves as investment manager or adviser to the Trust with respect to such series of shares.