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.
Authority” means any applicable Governmental Authority regulating or otherwise exercising authority with respect to
the Exploitation of Licensed Compounds or Licensed Products in the Territory, including the FDA in the United States and the EMA
in the European Union.
Documentation” means: all (i) applications (including all INDs and Drug Approval Applications), registrations,
licenses, authorizations and approvals (including Regulatory Approvals); (ii) correspondence and reports submitted to or
received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory
Authority) and all supporting documents with respect thereto, including all Adverse Event files and Complaint files; and (iii) clinical
and other data contained or relied upon in any of the foregoing; in each case ((i), (ii) and (iii)) relating to a Licensed Compound
or a Licensed Product.
Exclusivity Period” means, with respect to each Licensed Product in any country in the Territory, a period of exclusivity
(other than Patent exclusivity) granted or afforded by Applicable Law or by a Regulatory Authority in such country that confers
exclusive marketing rights with respect to such Licensed Product in such country, such as new chemical entity exclusivity, new
use or Indication exclusivity, new formulation exclusivity, orphan drug exclusivity, non-patent related pediatric exclusivity
or any other applicable marketing or data exclusivity, including any such periods listed in the FDA’s Orange Book or any
such periods under national implementations in the EU of Article 10 of Directive 2001/83/ED, Article 14(11) of Parliament and
Council Regulation (EC) No. 726/2004, Parliament and Council Regulation (ED) No. 141/2000 on orphan medicines, Parliament and
Council Regulation (ED) No. 1901/2006 on medicinal products for pediatric use and all international equivalents of any of the
Term” means, with respect to each Licensed Product and each country in the Territory, [*****].
Agreement” means a document that will outline the responsibilities for safety and regulatory management for the Licensed
Product(s) including the exchange of safety information, labeling responsibilities, safety surveillance and signal detection and
reporting to Regulatory Authorities in the Territory.
Category” means (a) those certain Indications set forth on Schedule 1.93, [*****].
Indication” means [*****].
Officer” means, with respect to ACI, its Chief Executive Officer and with respect to Lilly, its Vice-President of Research,
Neurodegeneration business unit.
Limitation” means, [*****].