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.
Suspensions or Withdrawals. Lilly shall make reasonable efforts to notify ACI in writing
promptly following its determination that any event, incident or circumstance has occurred that may result in the need for a recall,
market suspension or market withdrawal of a Licensed Product in the Territory and shall include in such notice the reasoning behind
such determination and any supporting facts. As between the Parties, Lilly shall have the right to make the final determination
whether to voluntarily implement any such recall, market suspension or market withdrawal in the Territory. If a recall, market
suspension or market withdrawal is mandated by a Regulatory Authority in the Territory, as between the Parties, Lilly shall initiate
such a recall, market suspension or market withdrawal in compliance with Applicable Law. For all recalls, market suspensions or
market withdrawals undertaken pursuant to this Section 3.3.3, as between the Parties, Lilly shall be solely responsible for
the execution and ACI shall reasonably cooperate in all such efforts. Subject to Article 11, Lilly shall be solely responsible
for all costs of any such recall, market suspension or market withdrawal, except in the event and to the extent that a recall,
market suspension or market withdrawal resulted from ACI’s or its Affiliate’s breach of its obligations hereunder
or from ACI’s or its Affiliate’s fraud, negligence or willful misconduct, in which case, ACI shall bear the expense
of such recall, market suspension or market withdrawal.
Safety Database. At the time Lilly submits a Drug Approval Application, Lilly shall establish,
hold and maintain (at Lilly’s cost and expense) the global safety database for Licensed Products. ACI shall provide Lilly
with all information necessary or desirable for Lilly to comply with its pharmacovigilance responsibilities under Applicable Law
in the Territory, including, as applicable, any adverse drug experiences (including those events or experiences that are required
to be reported to the FDA under 21 C.F.R. sections 312.32 or 314.80 or to foreign Regulatory Authorities under corresponding Applicable
Law outside the United States), from pre-clinical or clinical laboratory, animal toxicology and pharmacology studies, clinical
studies and commercial experiences with a Licensed Product, in each case in the form reasonably requested by Lilly. As needed,
the Parties shall negotiate in good faith and enter into a Safety-Regulatory Agreement to outline safety and regulatory responsibilities.
The Safety-Regulatory Agreement shall be in place prior to the start of parallel Joint Development Activities under this Agreement
by both Parties.
General. As between the Parties, Lilly shall have the sole right to Commercialize Licensed
Products in the Territory at Lilly’s sole cost and expense, subject to ACI’s Co-Promotion Option pursuant to Section
With respect to each Diligence Product that obtains Regulatory Approval in any country
within the Territory, Lilly shall use Commercially Reasonable Efforts to Commercialize such Diligence Product in the Field in