Common use of Regulatory Documentation Clause in Contracts

Regulatory Documentation. MedImmune hereby assigns to Kolltan all of MedImmune’s right, title and interest in and to any Regulatory Documentation relating to the Licensed Antibody or Licensed Products Controlled by MedImmune as of the Effective Date, including the Existing IND. Promptly after the Effective Date, MedImmune shall (a) transfer and/or disclose to Kolltan all such Regulatory Documentation and (b) provide Kolltan with an executed copy of a letter notifying the FDA of the assignment of the Existing IND to Kolltan. MedImmune shall submit such assignment letter to the FDA as soon as reasonably possible following the Effective Date and shall promptly notify Kolltan of MedImmune’s correspondence with the FDA with respect to such assignment. Promptly (but in no event more than [**] Business Days) thereafter, Kolltan shall submit to the FDA its acceptance of such transfer and provide MedImmune with written notice of such acceptance. The transfers and disclosures described in clause (a) above shall be made (x) in any manner or form reasonably requested by Kolltan and (y) at MedImmune’s expense; provided, however, if at Kolltan’s request any such transfer or disclosure is made in any manner or form that is not reasonably standard in the biopharmaceutical industry for transfers or disclosures of a similar kind, such transfer or disclosure shall be made at Kolltan’s expense.

Regulatory Documentation. MedImmune hereby assigns to Kolltan all of MedImmune’s right, title and interest in and to any Regulatory Documentation relating to the Licensed Antibody or Licensed Products Controlled by MedImmune as of the Effective Date, including the Existing IND. Promptly after the Effective Date, MedImmune shall (a) transfer and/or disclose to Kolltan all such Regulatory Documentation and (b) provide Kolltan with an executed copy of a letter notifying the FDA of the assignment of the Existing IND to Kolltan. MedImmune shall submit such assignment letter to the FDA as soon as reasonably possible following the Effective Date and shall promptly notify Kolltan of MedImmune’s correspondence with the FDA with respect to such assignment. Promptly (but in no event more than [**] five (5) Business Days) thereafter, Kolltan shall submit to the FDA its acceptance of such transfer and provide MedImmune with written notice of such acceptance. The transfers and disclosures described in clause (a) above shall be made (x) in any manner or form reasonably requested by Kolltan and (y) at MedImmune’s expense; provided, however, if at Kolltan’s request any such transfer or disclosure is made in any manner or form that is not reasonably standard in the biopharmaceutical industry for transfers or disclosures of a similar kind, such transfer or disclosure shall be made at Kolltan’s expense.