Co Development Program Clause Samples

Co Development Program. 2.1 The parties to this Agreement hereby agree to jointly co-develop Clofarabine for commercialization according to the terms of this Agreement. This Agreement supersedes all other written or verbal agreements, express or implied, between Ilex and Bioenvision relating to the subject matter hereof. Ilex shall be responsible for conducting all clinical trials and the filing and prosecution of all applications with applicable USA and Canadian regulatory authorities and all regulatory filings in the USA and Canada shall be in the name of Ilex. Ilex shall use all reasonable efforts to complete such actions and to obtain applicable regulatory approvals as promptly as practicable. In this regard, the parties contemplate attempting to obtain "orphan drug" status for Clofarabine but acknowledge that it may be necessary to seek regulatory approval on a different basis, Bioenvision shall be responsible for conducting all clinical trials and the filing and prosecution of all applications with applicable regulatory authorities other than in the USA and Canada and all such filings shall be in the name of Bioenvision. 2.2 Ilex shall be responsible for meeting the milestones and timetable set forth below: Milestone Completion Date --------- --------------- Completion of Pivotal Phase II Trials Ilex to use all reasonable efforts to cause such trials, as designed by Management, to be completed not later than 31 December 2002, but the parties acknowledge and agree that such trials may not be completed by such date notwithstanding Ilex's best efforts. The parties agree that if the trials are not completed by 31 December 2002, but are still ongoing and progressing to completion within a reasonable timeframe thereafter, the Milestone date shall be adjusted, accordingly. Filing of New Drug Application with US Not later than August 31, 2003; provided Food and Drug Administration that such date is consistent with the agreed upon regulatory strategy with the FDA and that the deadline shall be continued through the period ending on January 1, 2004 so long as Ilex continues to use all reasonable efforts to complete the filing in due form as promptly as reasonably practicable during such extended period. The parties acknowledge and agree that Bioenvision may agree to extend the deadline beyond January 1, 2004 upon request by Ilex, which agreement shall not be unreasonably withheld. 2.3 Management team ("Management") shall be established which will direct and supervise the Co-Developme...