Commercial Supply and Manufacturing of Alicaforsen API Sample Clauses

Commercial Supply and Manufacturing of Alicaforsen API. 3.6.1 Following the Effective Date, at Atlantic’s election, Isis and Atlantic will negotiate in good faith, agree and execute a separate written agreement for the commercial supply and manufacture of Alicaforsen API by Isis for Atlantic (the “Manufacturing Agreement”) such Manufacturing Agreement to be entered into within [***] of the Effective Date. Such Alicaforsen API will be manufactured in accordance with cGMP, applicable Alicaforsen API specifications, and the terms and conditions of the Manufacturing Agreement, which will include, among other standard commercial terms, Isis’ agreement to maintain a drug master file for Alicaforsen API (“DMF”) and Atlantic’s right to reference the DMF in its Regulatory Documentation. Should: (a) a Regulatory Authority in a particular jurisdiction in which Isis has not filed a DMF, or (b) a Regulatory Authority which does not allow cross-referencing to an existing DMF, request information regarding Alicaforsen API and its manufacture contained in a DMF somewhere in the world, Isis undertakes to (i) provide such information directly on behalf of Atlantic to the applicable Regulatory Authority, or if not legally possible (ii) consult with Atlantic in good faith regarding the appropriate response to such inquiry and to give Atlantic (and its relevant sub-licensee(s)) reasonable assistance with answering that Regulatory Authority’s questions, save that should a Regulatory Authority request Isis’s proprietary information relating to the Alicaforsen API or its manufacture outside of the definition of Isis Manufacturing Know-How Isis shall not be obliged to share such information with Atlantic (or its relevant sub-licensee(s)) and shall respond directly to the Regulatory Authority on Atlantic’s or the relevant sublicensee’s behalf. Notwithstanding Section 2.1.1 and 2.2.1 above, while Isis is manufacturing Alicaforsen API for Atlantic under the Manufacturing Agreement, Isis will transfer, at Atlantic’s written request and subject to the confidentiality obligations under Article 8, analytical methods within Excluded Manufacturing IP necessary to properly characterize and release the Alicaforsen API.
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Related to Commercial Supply and Manufacturing of Alicaforsen API

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