Common use of Documentation and Reports Clause in Contracts

Documentation and Reports. 19.1 The Parties shall comply with the terms of the Information Access Agreement. 19.2 The Supplier shall, or shall procure that any Nominated Supplier or Permitted Subcontractor (as applicable) shall: (A) maintain complete and maintain the documentation relating to the Manufacture of each batch of the Products in accordance with cGMP (including, without limitation, Batch Records, analysis and data supporting each Certificate of Analysis and Certificate of Compliance) and in accordance with the Quality Agreement and shall retain such documentation for the periods set out in the Quality Agreement; (B) supply to the Purchaser upon reasonable request copies of the documentation referred to in clause 19.2(A); (C) keep complete and systematic records of any other documentation generated pursuant to this Agreement; such records to include any operational documentation relating to Manufacture of the Product, any financial records and procedures (including records for compliance with Applicable Laws), distribution and disposition records and all such other documentation relating to the Products and Manufacturing activities under this Agreement; (D) preserve all records referred to in clause 19.2(C) in accordance with the relevant retention periods specified in the Quality Agreement (where applicable) and shall preserve any records not identified in such Quality Agreement for the greater of: (i) five years and (ii) such other period agreed in writing by the Parties; provided that, in the event a legal matter arises requiring preservation of certain records, the Supplier shall suspend destruction of such records as requested by the Purchaser or any Governmental Entity; and (E) permit the Purchaser, its Affiliates and their respective representatives access upon reasonable request during Working Hours to all records retained pursuant to this clause 19 (Documentation and Reports). 19.3 For the avoidance of doubt, nothing in clause 19.2(E) shall entitle the Purchaser, its Affiliates or their respective representatives to access financial records, which may be accessed only in accordance with clause 33 (Audit and Inspection Rights). 19.4 In the event of any conflict or inconsistency between the provisions of this clause 19 (Documentation and Reports) and the provisions of the Quality Agreement, the provisions of the Quality Agreement shall, to the extent of such conflict or inconsistency, prevail.

Documentation and Reports. 19.1 The Parties shall comply with the terms of the Information Access Agreement. 19.2 The Supplier shall, or shall (and shall procure that any Nominated Supplier or Permitted Subcontractor (as applicable) shall:its Affiliates will): (A) maintain complete and maintain the documentation relating to the Manufacture of each batch of the Products in accordance with cGMP (including, without limitation, Batch Records, analysis and data supporting each Certificate of Analysis and Certificate of Compliance) and in accordance with the Quality Agreement GMP and shall retain such documentation for the periods set out in Schedule 4 (or such other period as is defined in the Quality Agreement); (B) supply to the Purchaser Prestige upon reasonable request copies of the documentation referred to in clause 19.2(A)its analysis and data supporting each Certificate of Analysis; (C) provide to Prestige upon reasonable request all manufacturing and quality control records in respect of the Products and the Materials used in their Manufacture; (D) notify Prestige of any batch failures, process deviations and out of Specification results which arise during Manufacture of the Product and provide details of such batch failures, process deviations and out of Specification results as specified in the Quality Agreement; (E) conduct periodic Product quality reviews in accordance with the Quality Agreement; (F) complete and lodge with the appropriate Regulator or other Government Entity, where required, all documentation relating to the export of Products where their delivery involves export from the country of Manufacture; (G) keep complete and systematic records of any other documentation generated pursuant to this Agreement; such records to include any operational documentation relating to the Manufacture of the ProductProducts, any financial records and procedures (including records for compliance with Applicable Laws), distribution and disposition records and all such other documentation relating to the Products and Manufacturing activities under this Agreement; (DH) preserve all records referred to in clause 19.2(CClause 16 (G) in accordance with the relevant retention periods specified in Schedule 4 and the Quality Agreement (where applicable) and shall preserve any records not identified in such Schedule 4 or the Quality Agreement for the greater of: (i) five years and [***]; or (ii) such other period agreed in writing by the Parties; provided that, in the event a legal or regulatory matter arises requiring preservation of certain records, the Supplier shall (or shall procure its Affiliates will) suspend destruction of such records as requested by the Purchaser Prestige or any Governmental EntityRegulator; and (EI) without prejudice to Clause 18, permit the Purchaser, its Affiliates and their respective representatives Prestige access upon reasonable request during Working Hours normal business hours to all records retained pursuant to this clause 19 (Documentation and Reports)Clause 16. 19.3 For the avoidance of doubt, nothing in clause 19.2(E) shall entitle the Purchaser, its Affiliates or their respective representatives to access financial records, which may be accessed only in accordance with clause 33 (Audit and Inspection Rights). 19.4 In the event of any conflict or inconsistency between the provisions of this clause 19 (Documentation and Reports) and the provisions of the Quality Agreement, the provisions of the Quality Agreement shall, to the extent of such conflict or inconsistency, prevail.