USL’s Diligence Obligations Regarding Development of Product and Preparation of Product NDA. USL shall be responsible for diligently compiling the Product NDA in accordance with the Development Plan, and for having it filed with the FDA within five (5) months after USL’s receipt of all data, information and documents (including without limitation, all analyses and THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. re-analyses) necessary or beneficial to prepare such filing, and for obtaining FDA Acceptance of the Product NDA. Such filing shall include all data and documentation reasonably required for such Product NDA filing and be made in accordance with the then prevailing FDA requirements for form and content for such a filing.
Appears in 4 contracts
Samples: Quality Assurance Agreement (Osmotica Pharmaceuticals PLC), Quality Assurance Agreement (Osmotica Pharmaceuticals LTD), Quality Assurance Agreement (Osmotica Pharmaceuticals LTD)
