Drug Development Program Sample Clauses
Drug Development Program. A Compound which is identified by the Joint Research Committee as meeting the criteria in Attachment 2.1 set for Milestone II will be reviewed by Merck's internal system for acceptance of such Compound as a Safety Assessment Candidate. After identification of such a Safety Assessment Candidate, Merck will be responsible for and will undertake all preclinical development, toxicology and clinical development, including regulatory filings, which are required for commercialization. The progress and results of Merck's Drug Development Program, as well as such other information reasonably requested by Transcell relating to the progress, goals or performance of the Drug Development Program, will be reported to Transcell through semi-annual summary reports. Merck shall also notify Transcell upon (i) the filing of an IND with the FDA (ii) the filing of an NDA with the FDA and (iii) the approval of an NDA by the FDA. The information below marked by * and [ ] has been omitted pursuant to a request for confidential treatment. The omitted portion has been separately filed with the Commission. --------------------------------------------------------------------------------
Drug Development Program. A Compound which is identified by the Joint Research Committee as meeting the criteria in Attachment 2.1 set for Milestone II will be reviewed by Merck's internal system for acceptance of such Compound as a Safety Assessment Candidate. After identification of such a Safety Assessment Candidate, Merck will be responsible for and will undertake all preclinical development, toxicology and clinical development, including regulatory filings, which are required for commercialization. The progress and results of Merck's Drug Development Program, as well as such other information reasonably requested by Transcell relating to the progress, goals or performance of the Drug Development Program, will be reported to Transcell through semi-annual summary reports. Merck shall also notify Transcell upon (i) the filing of an IND with the FDA (ii) the filing of an NDA with the FDA and (iii) the approval of an NDA by the FDA.
Drug Development Program. = CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
2.12.1 For any Compound which is identified by the Joint Research Committee as meeting the Research Program criteria for selectivity and activity toward the specified Target as set forth in Section 1.6 herein, Merck may, at its sole discretion, elect to take such Compound forward within MERCK [*]. After [*], Merck may, at its sole discretion, undertake, and shall own the results of, all preclinical development, toxicology, clinical development, and Compound research and development. MERCK shall make any and all regulatory filings for such Compound and Product as Merck, in its sole discretion, deems appropriate, and shall be the sole owner of all regulatory submissions and government approvals.
2.12.2 For any Compound which Merck can show (i) existed in MERCK's collection prior to receipt of such Compound from NEOGENESIS or (ii) was licensed-in, or identified by or for MERCK independently of the Research Program, then such Compound shall not be considered a Compound hereunder, and shall not be subject to the terms of this Agreement, provided that, in the case of any Compound described in this Section 2.12.2 (i), MERCK shall notify NEOGENESIS that such Compound exists in MERCK's collection no later than the earlier of: a) the date on which MERCK requests NEOGENESIS to prepare a Focused Library for such Compound, or b) within ninety (90) days after NEOGENESIS provides the structure of such Compound to MERCK.
Drug Development Program