CONFIDENTIAL TREATMENT REQUESTED UNDER RULE 24B-2
UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
[*****] INDICATES OMITTED MATERIAL THAT IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST FILED SEPARATELY WITH THE COMMISSION. THE OMITTED MATERIAL HAS BEEN FILED SEPARATELY WITH THE COMMISSION.
2 Clinical Trial” means a human clinical trial of a pharmaceutical product candidate in subjects with a particular disease
or condition, with a principal purpose of evaluating the effectiveness, safety, and acceptable dose range for such product candidate
for a particular use, as described or contemplated by 21 C.F.R. §312.21(b).
3 Clinical Trial” means a human clinical trial of a pharmaceutical product candidate in subjects with a particular disease
or condition that is designed to establish that such product candidate is safe and efficacious for its intended use so as to support
Regulatory Approval of such product candidate, as described or contemplated by 21 C.F.R. §312.21(c); provided that it is
not intended that a human clinical trial must, by itself, support Regulatory Approval of a product candidate (including, for clarity,
itself establish that such product candidate is safe and efficacious for its intended use) in order to be a Phase 3 Clinical Trial.
means the Pharmaceuticals and Medical Devices Agency of Japan and any successor agency thereto.
Labeling” means, with respect to a Licensed Product in a country in the Territory, (i) the Regulatory Authority-approved
full prescribing information for such Licensed Product for such country, including any required patient information and (ii) all
labels and other written, printed or graphic matter upon a container, wrapper or any package insert utilized with or for such
Licensed Product in such country.
Trademarks” means the Trademark(s) used or to be used by Lilly or its Sublicensees for the Commercialization of Licensed
Products in the Territory and any registrations thereof or any pending applications relating thereto in the Territory (excluding,
in any event, any of ACI’s Corporate Names, any other Trademarks Controlled by ACI or any of its Affiliates and anything
confusingly similar to any of ACI’s Corporate Names or such Trademarks).
Agreement” means the document developed, approved, and updated by the Parties that sets forth the quality expectations,
responsibilities, rights (including, as applicable and agreed upon, audit requirements) and requirements relating to the Manufacture
and supply of Licensed Product as executed hereunder, or relating to supply of Licensed Product for Clinical Trials or Commercialization.
Approval” means, with respect to a country in the Territory, any and all approvals (including Drug Approval Applications),
licenses, registrations or authorizations of any Regulatory Authority necessary to commercially distribute, sell or market a Licensed
Product in such country, including, where applicable, (i) pricing or reimbursement approval in such country, (ii) pre-
and post-approval marketing authorizations (including any prerequisite Manufacturing approval or authorization related thereto)
and (iii) labeling approval.