Common use of Regulatory Documents Clause in Contracts

Regulatory Documents. Upon request by, and in mutual consultation with Client, Supplier shall be responsible for preparation of documentation on Manufacture of any products manufactured for Client as required for the Regulatory Submissions of Client, limited to Supplier’s activities under this agreement. Client shall provide portions of Regulatory Submissions, related to any products manufactured by Supplier for Client and Supplier’s, activities performed under this agreement, to Supplier for review and written consent, prior to submission to any Regulatory Authority. Client shall, upon submission to any Regulatory Authority, provide Supplier with current copies of portions of Regulatory Submissions. including amendments and supplements thereto, related to any products manufactured by Supplier for Client and Supplier’s activities performed under this agreement. Supplier will provide, in mutually agreed timelines, all other information related to any products manufactured by Supplier for Client that Client may reasonably request for its Regulatory Submissions, including any data for annual reports (e.g. annual stability reports). When a change is known to require, or has the potential to require a Regulatory Submission, Supplier with Client will develop a joint strategy to secure the appropriate regulatory approval prior to implementation of the change at Supplier and Client. For Change Control see section 3. Supplier shall be responsible for preparation of the Drug Master File related to any products manufactured for Client and submission of such documents to any Regulatory Authority, including maintaining such submissions (hereafter altogether called ‘DMF’).