Quality Agreements with Third Party Suppliers. Sublicensor and Sublicensee acknowledge that, pursuant to the Japanese Pharmaceutical Affairs Law, certain quality agreements are required to be entered into among Sublicensee and each direct or indirect supplier of intermediates, Compound, formulated Compound (interim product) (if any) and Product (each such agreement, a “Third Party Quality Agreement”), and that such Third Party Quality Agreement is required to enable Sublicensee to directly control quality matters with respect to intermediates, Compound, formulated Compound (interim product) (if any) and Product. The Parties also acknowledge that each such Third Party Quality Agreement shall be filed with Regulatory Authority at the time of the filing of the market approval for finished Product in the Sublicensee Territory. For this purpose, upon request of Sublicensee, Sublicensor shall use good faith efforts to reasonably cooperate with Sublicensee, and to cause each Third Party Manufacturer or supplier to cooperate with Sublicensee, in Sublicensee’s efforts to enter into such Third Party Quality Agreements with such Third Party(ies) in a timely manner.
Appears in 4 contracts
Samples: Sublicense Agreement (Keryx Biopharmaceuticals Inc), Sublicense Agreement (Keryx Biopharmaceuticals Inc), Sublicense Agreement (Keryx Biopharmaceuticals Inc)