Correspondence/Complaints. (a) Celltech shall promptly provide Orphan Medical with copies of any material regulatory correspondence with respect to the Product in the Territory and all related documentation, information and other materials received or prepared by Celltech, including, but not limited to, copies of the proposed applications for Marketing Authorization prepared by or on behalf of Celltech for Registration of the Products in the Territory and any subsequent amendments, supplements, or annual updates thereto. (b) Celltech agrees to inform Orphan Medical in writing of all significant complaints regarding the Product that relate to Product Specifications within fifteen (15) business days after Celltech’s receipt thereof in all countries of the Territory. Celltech shall also provide written quarterly reports of all complaints regarding the Product, regardless of significance, in English, as well as the actions taken by Celltech to address all such complaints. Such reports shall be delivered to Orphan Medical within thirty (30) days after the end of each calendar quarter during the Term.
Appears in 3 contracts
Samples: License and Distribution Agreement, License and Distribution Agreement (Celltech Group PLC), License and Distribution Agreement (Orphan Medical Inc)
Correspondence/Complaints. (a) Celltech shall promptly provide Orphan Medical with copies of any material regulatory correspondence with respect to the Product in the Territory and all related documentation, information and other materials received or prepared by Celltech, including, but not limited to, copies of the proposed applications for Marketing Authorization prepared by or on behalf of Celltech for Registration of the Products in the Territory and any subsequent amendments, supplements, or annual updates thereto.
(b) Celltech agrees to inform Orphan Medical in writing of all significant complaints regarding the Product that relate to Product Specifications within fifteen (15) business days after Celltech’s 's receipt thereof in all countries of the Territory. Celltech shall also provide written quarterly reports of all complaints regarding the Product, regardless of significance, in English, as well as the actions taken by Celltech to address all such complaints. Such reports shall be delivered to Orphan Medical within thirty (30) days after the end of each calendar quarter during the Term.
Appears in 3 contracts
Samples: License and Distribution Agreement (Orphan Medical Inc), License and Distribution Agreement (Orphan Medical Inc), License and Distribution Agreement (Orphan Medical Inc)