Know-How, Infrastructure, and Software. In connection with the Termination Assistance Services, Shire shall make available to Duramed or its designee, to the extent owned or controlled by and in the possession of Shire and reasonably required to manufacture the applicable Product, (i) copies of all applicable requirements, standards, policies, reports and report formats, user manuals, technical manuals, system architecture, processes, operating procedures and other documentation, (ii) copies of flow charts of the manufacturing procedures and work instructions related to manufacturing the relevant Product, (iii) a list of all material equipment, including the source of such equipment, utilized in the production of the applicable Product, (iv) copies of all current specifications, including packaging, for the relevant Product, (v) copies of all standard operating procedures for the manufacturing procedures to be made available to Duramed, (vi) all necessary environmental conditions necessary to manufacture the relevant Product and copies of any existing external environmental impact studies based on the materials or methods employed in the manufacturing method to be made available to Duramed, and (vii) such other documentation as the Parties may agree.
Know-How, Infrastructure, and Software. In connection with the Termination Assistance Services, Duramed shall make available to Shire or its designee, to the extent owned or controlled by and in the possession of Duramed and reasonably required to manufacture the applicable Shire Product, (i) copies of all applicable requirements, standards, policies, reports and report formats, user manuals, technical manuals, system architecture, processes, operating procedures and other documentation, (ii) copies of flow charts of the manufacturing procedures and work instructions related to manufacturing the relevant Shire Product, (iii) a list of all material equipment, including the source of such equipment, utilized in the production of the applicable Shire Product, (iv) copies of all current specifications, including packaging, for the relevant Shire Product, (v) copies of all standard operating procedures for the manufacturing procedures to be made available to Shire, (vi) all necessary environmental conditions necessary to manufacture the relevant Shire Product and copies of any existing external environmental impact studies based on the materials or methods employed in the manufacturing method to be made available to Shire, and (vii) such other documentation as the Parties may agree.
