MRR DOCUMENTS definition

MRR DOCUMENTS means all the final manufacturing and release requirements documents which shall set forth all Specifications and release requirements for Product(s) and as to each, its manufacture, including, without limitation, all raw materials, solvents, reagents, processing, storage, shipping and packaging specifications and necessary test protocols, final release specifications, Batch Records, Certificates of Analysis and Conformance and other documentation required to describe, control and assure the quality manufacture and testing of each in compliance with the Biologics License Application. "HOLLISTER-STIER MRR DOCUMENTS" shall refer to that portion of the ▇▇▇
MRR DOCUMENTS means a) all completed production/Batch records; b) all quality control test/request forms (result worksheets) and associated data; c) dynamic monitoring performed during processing; d) any alert/action notifications generated during processing; e) any planned or unplanned deviations associated with Product; f) any out of Specification result investigations associated with Product; g) the Certificate of Analysis for the Batch comparing testing to Specifications; h) the appropriate disposition notification for the Batch.

Related to MRR DOCUMENTS

  • RFP Documents means the following documents to be entered into by the parties to the respective agreements in connection with the supply of power:

  • Senior Documents means, collectively, with respect to any Senior Obligation, any provision pertaining to such Senior Obligation in any Loan Document or any other document, instrument or certificate evidencing or delivered in connection with such Senior Obligation.

  • Buyer Documents has the meaning set forth in Section 5.2.

  • Borrower Documents means the Financing Documents and the Mortgage Loan Documents to which the Borrower is a party.

  • Merger Documents means, collectively, this Agreement, the Certificate of Merger, and all other agreements and documents entered into in connection with the Merger and the other transactions contemplated hereby.