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.
the avoidance of doubt, if the exercise of the Unilateral Clinical Development Option is finally rejected in accordance with Section
3.2.3, then ACI may make future proposals to Lilly in accordance with Section 3.2. Once the Unilateral Clinical Development
Option has been exercised in accordance with Section 3.2.3, the Development activities with respect to the Eligible Indication
and the applicable Licensed Product prior to the exercise of the Unilateral Opt-In pursuant to Section 3.2.7(i) or Section
3.2.8 shall constitute “Unilateral Activities”.
relating to Unilateral Activities.
to Section 3.2.4, in the event that Lilly has a good faith belief that any Unilateral Activities would reasonably be expected
to have a material adverse effect on a Licensed Product for the First Indication or for any other Indication that is being Developed
or Commercialized by Lilly, Lilly may so notify ACI of such good faith belief along with a reasonably adequate basis for such
good faith belief and, upon receiving such notice, ACI shall not and shall cause its Affiliates not to conduct the Unilateral
may conduct any Unilateral Activities (a) using only such forms and formulations of the applicable Licensed Product as are
then being Manufactured and (b) using only such dose ranges as may be approved in writing by Lilly, which approval shall
not be unreasonably withheld, conditioned or delayed.
the avoidance of doubt, in the event that ACI exercises its Unilateral Clinical Development Option and Lilly does not reject such
exercise in accordance with the terms and conditions herein, ACI shall have the sole and exclusive right and responsibility, at
its sole cost and expense, (a) for the Development of the applicable Licensed Product in the applicable Unilateral Indication
and (b) to prepare, obtain and maintain Drug Approval Applications, other Regulatory Approvals and other submissions and
to conduct communications with the Regulatory Authorities for such Licensed Product in such Unilateral Indication, in each case
of clauses (a) and (b) until Lilly exercises, or is deemed to have exercised, its Unilateral Opt-In right.