Permits, Licenses and Approvals. During the Term of this Agreement, the Manufacturer shall have primary responsibility to and shall maintain all regulatory and governmental permits, licenses and approvals that are necessary for the Manufacture, Packaging and shipment of the Products and/or Packaged Tablets to the Company; provided, however, that the Parties understand and agree that the Company owns the NDA and, as a result, the Company will be responsible for any and all NDA-related filings required pursuant to this Section 7.3. Each Party agrees that, to the extent required to fulfill their respective obligations under this Section 7.3, each Party will reasonably cooperate and assist the other party at the requesting Party’s expense.
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Samples: Supply and Packaging Agreement, Supply & Packaging Agreement (Reliant Pharmaceuticals, Inc.), Supply & Packaging Agreement (Reliant Pharmaceuticals, Inc.)
Permits, Licenses and Approvals. During the Term of this Supply Agreement, the Manufacturer shall have primary responsibility to and shall maintain all regulatory and governmental permits, licenses and approvals that are necessary for the Manufacture, Packaging manufacture and shipment of the Products and/or Packaged Tablets to the Company; provided, however, that the Parties understand and agree that the Company owns the NDA NDAs and, as a result, the Company will be responsible for any and all NDA-related filings required pursuant to this Section 7.3. Each Party agrees that, to the extent required to fulfill their respective obligations under this Section 7.3, each Party will reasonably cooperate and assist the other party at the requesting Party’s 's expense.
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