Print Page     Close Window     

SEC Filings

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

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.

 

2.2.2.       a non-exclusive “Right of Reference,” as that term is defined in 21 C.F.R. § 314.3(b) (or any Applicable Law recognized outside of the United States), to, and a right to copy, access, and otherwise use, all information and data (including all CMC information as well as data made, collected or otherwise generated in the conduct of any Clinical Trials or early access/named patient programs for the Licensed Products) included in or used in support of any Regulatory Approval, drug master file or other Regulatory Documentation (including Assigned Regulatory Documentation, Assigned Regulatory Approvals and orphan drug applications and designations) maintained on behalf of, or Controlled by, Lilly (or its Sublicensees) that relates to any Licensed Product, in each case to the extent necessary to perform ACI’s Development obligations under this Agreement, including in connection with any conduct of any Unilateral Activities (it being understood that (i) Lilly will provide a signed statement to this effect, if requested in writing by ACI, in accordance with 21 C.F.R. § 314.50(g)(3) (or any Applicable Law outside of the United States) and (ii) upon the reasonable written request of ACI, Lilly will, and will cause its Sublicensees to, obtain and provide to ACI certificates or other formal or official attestations concerning the regulatory status of the Licensed Products (e.g., Certificates of Free Sale, Certificates for Export, Certificates to Foreign Governments) to the extent that such attestations are reasonably necessary to exercise its rights under this Section ‎2.2.2.

 

2.3.       Sublicenses.

 

2.3.1.       Lilly shall have the right to grant sublicenses, through multiple tiers, under the licenses granted in Section ‎2.1, to its Affiliates and any Third Party. With respect to each such sublicense, [*****]. Notwithstanding the foregoing, Lilly shall not grant any sublicense to any Third Party of all or substantially all of Lilly’s rights under this Agreement without ACI’s prior written consent. For the avoidance of doubt, Lilly shall remain directly responsible for all of its respective obligations under this Agreement, notwithstanding the grant of any sublicense hereunder and no such sublicense shall alter, reduce or otherwise modify Lilly’s obligations hereunder.

 

2.3.2.       Subject to the requirements of this Section ‎2.3.2, ACI shall have the right to grant sublicenses (or further rights of reference), through multiple tiers, under the licenses and rights of reference granted in Section ‎2.2, to its Affiliates and, with Lilly’s prior written consent, to Third Parties, which consent shall not be unreasonably withheld, conditioned or delayed. With respect to each such sublicense, [*****]. For the avoidance of doubt, ACI shall remain directly responsible for all of its respective obligations under this Agreement, notwithstanding the grant of any sublicense hereunder and no such sublicense shall alter, reduce or otherwise modify ACI’s obligations hereunder.

 

20 


© AC Immune 2015