Regulatory Responsibility. The preparation, filing, prosecution and maintenance of INDs, BLAs and other regulatory filings required to be filed with any Regulatory Authority with regard to each Product will be in the name of and the responsibility of Alexion. Alexion shall own the Regulatory Approvals. The costs incurred by the Parties in the preparation, filing and submission of such regulatory filings will be deemed Development Expenses and subject to the terms of Section
Appears in 3 contracts
Sources: Co Development and Co Commercialization Agreement (Alexion Pharmaceuticals Inc), Co Development and Co Commercialization Agreement (Xoma LTD /De/), Co Development and Co Commercialization Agreement (Xoma LTD /De/)