General. Arcus shall be solely responsible for, and shall use Commercially Reasonable Efforts in connection with seeking Regulatory Approval for Licensed Products in the Territory. Summaries of any substantive (but not merely procedural) communications or interactions with a Regulatory Authority in the United States, European Union and Japan, to the extent material to Arcus performance of its obligations under this Agreement, will be included in the Development reports referred to in Section 3.1. WuXi shall provide Arcus with all information, data and materials reasonably requested by Arcus in support of its regulatory filings for Licensed Products, including # the Product/Manufacturing Information or Chemistry, Manufacturing and Controls section of an IND or NDA/BLA and any foreign equivalents thereof and # the drug master file and/or letter of authorization permitting incorporation of such information in an IND or NDA/BLA and any foreign equivalents thereof.
Development and Commercialization Activities. Arcus shall use Commercially Reasonable Efforts to Develop and Commercialize Licensed Products. Arcus shall use Commercially Reasonable Efforts to manufacture or otherwise obtain supply of its requirements of packaged and labeled Licensed Products in connection with its Development and Commercialization obligations hereunder, in accordance with all Applicable Laws, GMP (as applicable) and this Agreement. For so long as Arcus is conducting Development activities under this Agreement, Arcus shall provide to WuXi, no later than on June 30 and December 31 of each calendar year, with written summaries of the Development activities it performed, or caused to be performed, in respect of Licensed Products since the preceding report (or, with respect to the first such report, since the Effective Date), and the future Development activities it CERTAIN INFORMATION IN THIS DOCUMENT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
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