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.
Pre-Clinical and Phase 1 Activities” means those certain Development activities to be conducted and funded by ACI, as
set forth in the Development Plan as such Development Plan exists as of the Execution Date or as otherwise agreed by the Parties
in writing or through other documentation (including electronic communications).
“Additional Indication Triggering Event” means [*****].
Event” means any untoward medical occurrence in a patient or human clinical investigation subject administered a Licensed
Product pursuant to this Agreement, including occurrences which do not necessarily have a causal relationship with any Licensed
means, with respect to a Party, any Person that, directly or indirectly, through one (1) or more intermediaries, controls, is
controlled by or is under common control with such Party, whether now or in the future. For purposes of this definition, “control”
and, with correlative meanings, the terms “controlled by” and “under common control with” means: (i) the
possession, directly or indirectly, of the power to direct the management or policies of a business entity, whether through the
ownership of voting securities, by contract relating to voting rights or corporate governance or otherwise; or (ii) the ownership,
directly or indirectly, of more than fifty percent (50%) of the voting securities or other ownership interest of a business entity
(or, with respect to a limited partnership or other similar entity, its general partner or controlling entity).
Law” means with respect to any Person, any transnational, domestic or foreign federal, state or local law (statutory,
common or otherwise), constitution, treaty, convention, ordinance, code, rule, regulation, order, injunction, judgment, decree,
ruling or other similar requirement enacted, adopted, promulgated or applied by a Governmental Authority that is binding upon
or applicable to such Person, as amended unless expressly specified otherwise, including all applicable regulations and guidances
of any Regulatory Authorities (e.g., with respect to Good Laboratory Practices, Good Manufacturing Practices and Good Clinical
Practices and, if and as appropriate under the circumstances, International Conference on Harmonization (ICH) guidance).
Technology” means, with respect to a Party, all Patents, Information and other intellectual property rights (i) Controlled
by such Party as of immediately prior to the Effective Date or (ii) that becomes Controlled by such Party at any time during
the Term outside the scope of any of such Party’s activities under this Agreement.
mean [*****] identified by or on behalf of ACI in conjunction with its performance of [*****] or at any time on or before [*****],
or such later date as the Parties may mutually agree.