Discovery Products. Biogen will own all INDs, Orphan Drug Designations, Marketing Applications and related documentation submitted to any Regulatory Authority and all Regulatory Approvals with respect to the Discovery Products. Biogen will be solely responsible for all regulatory matters relating to the Discovery Products, including (i) overseeing, monitoring and coordinating all regulatory actions, communications and filings with, and submissions to, Regulatory Authorities with respect to the Discovery Products; (ii) interfacing, corresponding and meeting with Regulatory Authorities with respect to the Discovery Products; (iii) submitting and maintaining all regulatory filings with respect to the Discovery Products; and (iv) maintaining and submitting all records required to be maintained or required to be submitted to any Regulatory Authority with respect to the Discovery Products.
Discovery Products. Biogen shall have the sole and exclusive responsibility for and control of Commercialization of the Discovery Products.
Discovery Products. Biogen shall be solely responsible for Manufacturing clinical and commercial supply of the Discovery Products, either itself or through one or more Affiliates or Third Party Subcontractors. In the event that the Parties mutually agree that AGTC (or its Affiliate or Third Party Subcontractor) will Manufacture clinical supply of any Discovery Products for use by Biogen in Clinical Trials or other Development activities conducted by Biogen under this Agreement, the Parties will discuss in good faith and agree upon reasonable terms, including quality assurance provisions, for such Manufacture and supply. Biogen shall, subject to the terms and retained rights included in the Existing License Agreements as set forth in Section 11.4, have sole ownership of those portions of the master cell banks delivered to Biogen under Section 11.3 and applicable viral seed stocks and/or master viral banks, reagents and reference standards for such Discovery Product, or, if AGTC does not have ownership of the foregoing Materials, AGTC shall, and hereby does, transfer to Biogen all of AGTC’s right, title and interest in and to such Materials .
Discovery Products. Biogen shall be solely responsible for Manufacturing clinical and commercial supply of the Discovery Products, either itself or through one or more Affiliates or Third Party Subcontractors. In the event that the Parties mutually agree that AGTC (or its Affiliate or Third Party Subcontractor) will Manufacture clinical supply of any CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. TRIPLE ASTERISKS [***] DENOTE OMISSIONS. 56 B4849167.1 Discovery Products for use by Biogen in Clinical Trials or other Development activities conducted by Biogen under this Agreement, the Parties will discuss in good faith and agree upon reasonable terms, including quality assurance provisions, for such Manufacture and supply. Biogen shall, subject to the terms and retained rights included in the Existing License Agreements as set forth in Section 11.4, have sole ownership of those portions of the master cell banks delivered to Biogen under Section 11.3 and applicable viral seed stocks and/or master viral banks, reagents and reference standards for such Discovery Product, or, if AGTC does not have ownership of the foregoing Materials, AGTC shall, and hereby does, transfer to Biogen all of AGTC’s right, title and interest in and to such Materials .
