If either Party becomes aware of information relating to any Bulk Drug Product that indicates that a unit or batch of Bulk Drug Product may not conform to the Specifications therefor, or that potential adulteration, misbranding, or other issues have arisen that relate to the safety or efficacy of Bulk Drug Products, it shall promptly so notify the other Party. Company shall have the right and responsibility to control any recall, field correction, or withdrawal of, including any FDA field alert or EMA rapid report relating to, Bulk Drug Product (“Recall”) that is required by Regulatory Authorities in the Territory. In addition, Company shall have the right, at its discretion, to conduct any Recall in the Territory that is not so required by such Regulatory Authorities but that Company deems to be appropriate.