Common use of Clinical Development Clause in Contracts

Clinical Development. Copies of the following items that are Controlled by NOVARTIS, its Affiliates or the University of Minnesota (in the case of the University of Minnesota, in NOVARTIS’ possession) in each case below, solely as they relate to the HemOnc IND and the IMD IND: 2.3.3.1. An electronic copy of the then current databases as of the Effective Date, (a) the clinical study database, (b) the safety database, and (c) the PK and biomarker database. In addition, for study 2204, Novartis will refresh the safety database annually, or on an as requested basis, in no case more frequently than on a semi-annual basis; CONFIDENTIAL TREATMENT REQUESTED. INFORMATION FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED IS OMITTED AND MARKED WITH “[***]”. AN UNREDACTED VERSION OF THE DOCUMENT HAS ALSO BEEN FURNISHED SEPARATELY TO THE SECURITIES AND EXCHANGE COMMISSION AS REQUIRED BY RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED. 2.3.3.2. material protocols and amendments, study reports and results (including tables, figures and data); 2.3.3.3. All adverse event reports (e.g., Medwatch or equivalent forms); 2.3.3.4. Case Report Forms (CRFs) or equivalents thereof for all completed clinical studies of the Products (i.e., studies with signed-off final clinical study reports); 2.3.3.5. An electronic copy of clinical study raw data from clinical studies included in study databases; 2.3.3.6. all Trial Master Files (TMF’s) or equivalents thereof, to the extent such TMFs are in NOVARTIS’ or its Affiliates’ possession; and 2.3.3.7. To the extent any of the Documentation set forth in Sections 2.3.3.1—2.3.3.6 is in possession of the University of Minnesota as of the Effective Date, then Novartis agrees to notify the University of Minnesota of the license grant under this Agreement and will reasonably cooperate with LICENSEE to request and obtain such Documentation.