Common use of Licensor will Clause in Contracts

Licensor will. 5.2.1 Diligently progress the Initial NDA through to NDA Approval, including effecting all such Clinical Trials as may reasonably be required on the terms of Clause 7.2, promptly dealing with all matters and issues raised by the FDA in connection therewith and paying all fees (including the PDUFA fee) payable on or in connection with such NDA Approval. Licensee will give reasonable assistance to Licensor in such matters provided that in the event that in connection with the Initial NDA the FDA requests any Clinical Trials, the Parties shall act in connection with such Clinical Trials in accordance with Clause 7.2; 5.2.2 Keep the Licensee fully informed of the progress of the Initial NDA, by reports to the JSC and otherwise as reasonably required; 5.2.3 Provide the Licensee with reasonable advance notice of all material meetings or calls with the FDA relating to the Initial NDA. Two representatives of Licensee may attend such meetings or calls at Licensee’s own cost and expense; and 5.2.4 On NDA Approval promptly transfer the Initial NDA into the sole name of the Licensee.

Appears in 2 contracts

Sources: License and Supply Agreement (Salix Pharmaceuticals LTD), License and Supply Agreement (Salix Pharmaceuticals LTD)