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.
Costs” means [*****].
or “$” means United States Dollars.
Approval Application” means a New Drug Application as defined in the FFDCA or any corresponding foreign application
in the Territory, including, with respect to the European Union, a Marketing Authorization Application filed with the EMA pursuant
to the centralized approval procedure or with the applicable Regulatory Authority of a country in the European Union with respect
to the mutual recognition or any other national approval.
Date” the Business Day following the date on which HSR Clearance occurs.
means the European Medicines Agency and any successor agency thereto.
Union” or “EU” means the economic, scientific and political organization of member states of the
European Union, as it is constituted from time to time throughout the Term.
Co-Promotion Option Term” means, [*****].
Regulatory Documentation” means the Regulatory Documentation Controlled by ACI or any of its Affiliates as of the Effective
means to make, have made, import, use, sell or offer for sale, including to research, Develop, Commercialize, register, Manufacture,
have Manufactured, hold or keep (whether for disposal or otherwise), have used, export, transport, distribute, promote, market
or have sold or otherwise dispose of. “Exploitation” means the act of Exploiting a compound, product or process.
means the United States Food and Drug Administration and any successor agency thereto.
means the United States Federal Food, Drug, and Cosmetic Act, as amended from time to time, together with any rules, regulations
and requirements promulgated thereunder (including all additions, supplements, extensions and modifications thereto).
means all Indications and all uses, including the prevention, cure, amelioration or treatment in the First Category, Second Category,
and Third Category[*****].