General Development Plan. The General Development Plan has been prepared and approved by the Parties and is annexed to and made part of this Agreement as Appendix A. The General Development Plan outlines (i) all current and planned clinical studies and/or protocols, (including, but not limited to the amended protocol in the Field to add an endpoint measuring time to recurrence of disease) for completion of the Phase III Clinical Trial, and (ii) estimated timelines for completion of clinical and manufacturing tasks to be undertaken to support the Registration of the Product, taking into consideration the requirements of the FDA. The General Development Plan shall be updated annually by incorporation of the Annual [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. Development Plan(s) and may be further amended, at any time and from time to time, as approved by the JDC.
Appears in 2 contracts
Sources: License and Development Agreement (Dusa Pharmaceuticals Inc), License and Development Agreement (Dusa Pharmaceuticals Inc)