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SEC Filings

20-F
AC IMMUNE SA filed this Form 20-F on 03/21/2019
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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.

 

(ii)       As between the Parties, Lilly shall have the sole right for performing the Lilly Pre-Clinical Activities. “Lilly Pre-Clinical Activities” means the activities set forth on Schedule 3.1.2(ii). Lilly may, in its sole discretion, conduct the Lilly Pre-Clinical Activities during the period beginning on the Effective Date and ending [*****] thereafter; [*****]. ACI shall provide reasonable assistance to Lilly in conducting the Lilly Pre-Clinical Activities, including by providing, upon Lilly’s request, such commercially reasonable quantities of the Licensed Compound as Lilly may require (but in no case more than [*****] Licensed Compound).

 

(iii)     As between the Parties, ACI shall have the sole right and responsibility, in accordance with the terms of this Section 3.1.2‎(iii), for performing the ACI Pre-Clinical and Phase 1 Activities; [*****]. ACI shall perform the ACI Pre-Clinical and Phase 1 Activities in accordance with the Development Plan and such protocol as applicable and, in the case of any Phase 1 Clinical Trial that is part of the ACI Pre-Clinical and Phase 1 Activities, conduct such Phase 1 Clinical Trial at clinical trial sites approved by Lilly, which approval will not be unreasonably withheld, conditioned or delayed; provided, that Lilly may perform a GCP compliance audit/assessment of the Clinical Trial site prior to approval. [*****]. In the event that ACI identifies any Backups, ACI shall notify Lilly in writing of such identification within thirty (30) days thereof.

 

(iv)     The JSC shall review the Development Plan at least annually for the purpose of considering appropriate amendments thereto. In addition, either Party, through its representatives on the JSC, may propose amendments to the Development Plan for Joint Development Activities at any time. All internal personnel and resources shall be expressed in terms of FTEs and the budgeted cost shall be calculated using the relevant FTE Rates. Notwithstanding any other provision of this Section ‎3.1.2 or any provisions of Article 5 the Development Plan shall not be amended to extend ACI’s conduct of any pre-clinical studies and activities beyond the date that is [*****] (or such later date as the Parties may agree) or expand ACI’s obligations in any manner that would require ACI to incur any additional costs and expenses without the prior written agreement of the Parties.

 

(v)      Under the direction and supervision of the JSC, each Party shall perform the responsibilities assigned to it under the applicable Development Plan and shall use Commercially Reasonable Efforts to do so in accordance with the timelines set forth in the Development Plan. Each Party shall perform or cause to be performed, any and all of its Joint Development Activities in accordance with the Development Plan (including with respect to ACI, the budget set forth therein) and in good scientific manner and in compliance with all GxPs and Applicable Law by allocating sufficient time, effort, equipment, and skilled personnel to complete such Joint Development Activities.

 

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