Supply by AEVI. Subject to Section 5.3.3, AEVI will Manufacture and supply all of KKC’s requirements of Licensed Product for Commercialization and/or Development outside the Field in the Territory and outside the Territory. AEVI will supply KKC with unlabeled vialed Licensed Product for clinical trials conducted (a) outside the Territory, and (b) outside of the Field in the Territory and unlabeled vialed Licensed Product for Commercialization (i) outside the Territory or (ii) outside the Field in the Territory, in each case at (***). AEVI’s distribution of Licensed Product will be to a single distributor or Affiliate of KKC, as directed by KKC. AEVI will ship all Licensed Product FCA (INCOTERMS 2020) AEVI’s point of destination. The Parties will use Commercially Reasonable Efforts to complete within (***) after the Effective Date a supply agreement governing the terms of such supply by AEVI to KKC containing reasonable and customary terms contained herein and those additional terms typically associated with supply of pharmaceutical products (the “Supply Agreement”).
Supply by AEVI. Following KKC’s exercise of the Japan Option, AEVI will Manufacture and supply all of KKC’s requirements of Licensed Product for Commercialization and/or Development in Japan. AEVI will supply KKC with unlabeled Licensed Product (vial or any other formulation) for clinical trials conducted in Japan and unlabeled Licensed Product (vial or any other formulation) for Commercialization in Japan, in each case (***). AEVI will ship all Licensed Product FCA (INCOTERMS 2020) AEVI’s point of distribution. The Parties will use Commercially Reasonable Efforts to complete within (***) after the date on which KKC exercises the Japan Option a supply agreement governing the terms of such supply by AEVI to KKC containing reasonable and customary terms contained herein and those additional terms typically associated with supply of pharmaceutical products (the “Supply Agreement”) and a quality agreement related to the Supply Agreement.
Supply by AEVI. AEVI will Manufacture and supply all of KKC’s requirements of Licensed Product for Commercialization and/or Development outside the Field in the Territory. AEVI will supply KKC with unlabeled vialed Licensed Product for clinical trials conducted outside of the Field in the Territory and unlabeled vialed Licensed Product for Commercialization outside the Field in the Territory, in each case (***). AEVI will ship all Licensed Product FCA (INCOTERMS 2020) AEVI’s point of destination. The Parties will use Commercially Reasonable Efforts to complete within (***) after the Effective Date a supply agreement governing the terms of such supply by AEVI to KKC containing reasonable and customary terms contained herein and those additional terms typically associated with supply of pharmaceutical products (the “Supply Agreement”).
