Subsequent Information. Within eighteen (18) months following the Effective Date ▇▇▇ shall deliver the remaining documents mentioned in Appendix C, which are related to the following: (i) copies of all patient records, (ii) copies of trial master file material, (iii) copies of CT scans, (iv) copies of electronic (raw) data of trials, incl. adverse event reports and statistical files, (v) final reports of the EBC 9609, EBC 9702 and EBC 9802 trials as mentioned above in Clause 10.1. Cougar acknowledges and accepts that the amount of documentation prevents ▇▇▇ from undertaking any legal obligation to supply the entire or the majority part of the documentation at an earlier date than 18 months from the Effective Date. However, as a sign of its good faith LEO will within the above-mentioned 18 months period, to the extent practically possible, upon request from Cougar and subject to 6 months prior notice in respect of each such request from Cougar use it reasonable endeavours to execute and deliver to Cougar specified documents as Cougar may request from ▇▇▇. Furthermore, ▇▇▇ shall, at any time, reasonably cooperate with Cougar and provide Cougar with such assistance as reasonably may be requested by Cougar, including with respect to the transfer of clinical data and filings with the FDA. Should Cougar inform ▇▇▇ that any specific documentation is needed for regulatory purposes (US or international), ▇▇▇ will allow a representative of Cougar to have access to such documentation at ▇▇▇. The provision of such information (as paper copies) shall be at the expense of Cougar, who shall cover all external costs related hereto up to a maximum amount of [***]. Notwithstanding the aforementioned Cougar may at any time during the term of this Agreement request access to all the data kept by ▇▇▇ as mentioned above in this Clause 10.2.
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Sources: License Agreement (Cougar Biotechnology, Inc.), License Agreement (Cougar Biotechnology, Inc.)