Common use of Manufacturing and Delivery Clause in Contracts

Manufacturing and Delivery. During the Term, and subject to the provisions of this Section 7, AeroGen shall manufacture for and supply to PathoGenesis, and PathoGenesis shall purchase from AeroGen, all of the requirements of PathoGenesis, its Affiliates and sublicensees for the Inhalers and Adapters (excluding the Ampoules) in the Territory. AeroGen shall manufacture the Inhaler: (i) in compliance with cGMP; (ii) in compliance with all regulatory requirements imposed by FDA; and (iii) in accordance with AeroGen's internal quality control standards and product specifications or as otherwise agreed upon by AeroGen and PathoGenesis. To enable AeroGen to comply with its obligations with respect to regulatory requirements outside the United States, PathoGenesis shall inform AeroGen as early as practical of its intention to pursue regulatory approval of the Product in a country outside the United States. Upon AeroGen's reasonable request, PathoGenesis and AeroGen shall meet and confer regarding the regulatory requirements of such country, compliance therewith, the timeline for compliance, the costs associated with compliance and the manufacture of the Inhaler in compliance therewith. The quantities and delivery schedules shall be as specified in Section 7.4 hereof and in purchase orders submitted to AeroGen by PathoGenesis. At PathoGenesis' reasonable request, AeroGen shall provide PathoGenesis with documentation for the purpose of verifying AeroGen's compliance with this section. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.