ANDA Holder’s Responsibilities Clause Samples
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ANDA Holder’s Responsibilities. As the owner and holder of the ANDA, Insys shall be responsible for preparing and filing the ANDA for the Product, and for any new temperature stable version which Insys may develop. Insys shall own the ANDA and shall perform all regulatory functions in accordance with applicable Law and requirements of the FDA, including the filing of all annual and other reports or filings required by the FDA, and all other regulatory and governmental permits, licenses and approvals for the Product in accordance with the terms of this Agreement. Both the Parties will communicate with each other with regard to any regulatory issues that may arise before or after the final approval.
ANDA Holder’s Responsibilities. As the holder of the ANDAs, DPSI will have sole authority to deal with regulatory matters relating to the Product except as otherwise specifically stated in this Agreement. During the Term of this Agreement, DPSI shall pay all associated fees and maintain all ANDAs for the Product in accordance with applicable Law and requirements of the FDA, including the filing of all annual and other reports or filings required by the FDA, and all other regulatory and governmental permits, licenses and approvals for the Product that are necessary for DPSI to manufacture, package, test, label, handle and ship the Product to Mylan and its Affiliates in accordance with the terms of this Agreement and applicable Law.