Specific Product Information. In addition to the information identified in Section 2.4(a) above, Corium agrees to maintain a confidential dossier including information concerning the composition of the Product; the manufacturing process; quality control testing and release methods; scale-up and process validation data; and batch release and stability data. Corium shall provide such information (or right of reference thereto such as a right of reference to a Drug Master File) as required by law or as necessary to obtain regulatory approval for the manufacture of the Product to (i) Agile or (ii) the applicable regulatory agency, at Agile’s election. Corium shall also provide to Agile any information (including but not limited to analytical methodology and assays) available to Corium and necessary for Agile to determine compliance with the Product Specification and to perform quality control and batch release functions.
Specific Product Information. Product Improvements – Pamlico Air reserves the right to change materials/processes as deemed appropriate to facilitate product improvements. Therefore, product configuration may be slightly different than that depicted in product literature. Any changes made will be within the confines of industry specifications for each respective product.
