NOF shall prepare and keep batch records and shall retain samples, properly stored in accordance with the Quality Agreement, from each batch of the Activated PEG manufactured by NOF. NOF shall comply with cGMP in retaining batch records and samples. NOF shall prepare and keep complete and accurate records of all the Activated PEG manufactured for CREALTA consistent with cGMP requirement. Subject to the confidentiality obligations set out in ARTICLE 6, CREALTA or its designee shall have access to all such records and samples on reasonable notice and during normal business hours. In the event CREALTA requires records or documentation, other than those to be maintained by NOF as described above, to file applications to a Regulatory Authority, NOF will assist CREALTA in the preparation of such records and documentation to the extent requested by CREALTA and at CREALTA’s expense.