Selecting a CMO Sample Clauses

Selecting a CMO. Within [***] after Initiation of the PoC Trial or, if Biogen Idec exercises the Option prior to the Initiation of the PoC Trial, at such earlier time as the Parties may agree, the Parties will discuss in good faith a supply chain strategy to ensure adequate supply of Clinical Supplies for any Clinical Studies to be conducted after Option exercise and API and finished drug Product for Commercialization of a Product (“Commercial Supplies”), including selection of a CMO to supply or re-supply such Clinical Supplies or Commercial Supplies, validation batches and support for filings with applicable Regulatory Authorities in support of obtaining Approval, pursuant to the terms of a written agreement with a CMO. Notwithstanding the foregoing, Biogen Idec will have the right to select one or more CMOs to manufacture Clinical Supplies for any Clinical Studies to be conducted after Option exercise and Commercial Supplies and enter into Manufacturing Agreements with such CMO(s) in accordance with Section 1.5.3.

Selecting a CMO. (a) Within [***] after the Effective Date, the Parties will discuss and mutually agree upon a supply chain strategy, including selection of a CMO to supply or re-supply API and finished drug Product for (i) the CS3 Study and CS4 Study and any Clinical Studies planned after the CS2 Study that the Parties may later add to the ISIS-SMNRX Development Plan (“Clinical Supplies”), and (ii) Commercialization of a Product, including validation batches and support for filings with applicable Regulatory Authorities in support of obtaining Approval (“Commercial Supplies”), pursuant to the terms of a written agreement with a CMO approved by Biogen Idec and Isis in accordance with Section 1.5.2. On or prior to the Effective Date, Isis will provide Biogen Idec a list of approved CMOs for the Manufacture of API (the “CMO List”), which CMO List may be amended at any time by mutual written agreement of the Parties. In addition, Isis and Biogen Idec will work together to add to the CMO List an appropriate list of approved CMOs for finished drug Product. (b) The Parties’ goal is to mutually agree on the CMO(s) selected from the CMO List to Manufacture Clinical Supplies and Commercial Supplies. Biogen Idec will select, in Biogen Idec’s sole discretion, one or more CMOs for the Manufacture of Clinical Supplies and Commercial Supplies from the CMO List; provided, that Biogen Idec will use good faith efforts to select a CMO that will Manufacture Commercial Supplies [***]. For purposes of clarity, this Section 1.5.1 will not limit Biogen Idec’s sole discretion to select a CMO to Manufacture Commercial Supplies.