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.
means the adherence by the Parties in all material respects to all Applicable Law and Party Specific Regulations, in each case
with respect to the activities to be conducted under this Agreement.
Audit” means an assessment or inspection conducted to verify compliance with applicable regulatory standards (GxPs)
means, with respect to any item of Information, Regulatory Documentation, material, Patent or other intellectual property right,
and subject to Section 13.3.2, possession of the right, whether
directly or indirectly and whether by ownership, license or otherwise (other than by operation of the license and other grants
in Section 2.1 or 2.2), to grant a license, sublicense or other right (including the right to reference Regulatory Documentation)
to or under such Information, Regulatory Documentation, material, Patent or other intellectual property right as provided for
herein without (i) violating the terms of any agreement with any Third Party, and (ii) paying any consideration to any Third Party.
Note Agreement” means that certain Convertible Note Agreement dated as of the date hereof between Lilly and ACI.
or “Co-Promotion” means the detailing, through a face-to-face contact between a sales representative and a
physician or other medical professional licensed or authorized to prescribe drugs, of the applicable Licensed Product by ACI or
any of its Affiliates in the applicable Indication under the relevant Regulatory Approval and the Product Trademarks, but excluding
the sale or distribution of such Licensed Product by ACI or any of its Affiliates.
Names” means [*****].
means, with respect to any compound or product, all activities related to research, pre-clinical and other non-clinical testing,
test method development and stability testing, toxicology, formulation, process development, manufacturing scale-up, qualification
and validation, quality assurance/quality control, clinical studies of such compound or product, including Manufacturing in support
thereof, statistical analysis and report writing, the preparation and submission of Drug Approval Applications and regulatory
affairs with respect to the foregoing and all other activities necessary or reasonably useful or otherwise requested or required
by a Regulatory Authority as a condition or in support of obtaining or maintaining a Regulatory Approval for such compound or
product. When used as a verb, “Develop” means to engage in Development.