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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.

 

1.88.       Regulatory Authority” means any applicable Governmental Authority regulating or otherwise exercising authority with respect to the Exploitation of Licensed Compounds or Licensed Products in the Territory, including the FDA in the United States and the EMA in the European Union.

 

1.89.       Regulatory Documentation” means: all (i) applications (including all INDs and Drug Approval Applications), registrations, licenses, authorizations and approvals (including Regulatory Approvals); (ii) correspondence and reports submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents with respect thereto, including all Adverse Event files and Complaint files; and (iii) clinical and other data contained or relied upon in any of the foregoing; in each case ((i), (ii) and (iii)) relating to a Licensed Compound or a Licensed Product.

 

1.90.       Regulatory Exclusivity Period” means, with respect to each Licensed Product in any country in the Territory, a period of exclusivity (other than Patent exclusivity) granted or afforded by Applicable Law or by a Regulatory Authority in such country that confers exclusive marketing rights with respect to such Licensed Product in such country, such as new chemical entity exclusivity, new use or Indication exclusivity, new formulation exclusivity, orphan drug exclusivity, non-patent related pediatric exclusivity or any other applicable marketing or data exclusivity, including any such periods listed in the FDA’s Orange Book or any such periods under national implementations in the EU of Article 10 of Directive 2001/83/ED, Article 14(11) of Parliament and Council Regulation (EC) No. 726/2004, Parliament and Council Regulation (ED) No. 141/2000 on orphan medicines, Parliament and Council Regulation (ED) No. 1901/2006 on medicinal products for pediatric use and all international equivalents of any of the foregoing.

 

1.91.       Royalty Term” means, with respect to each Licensed Product and each country in the Territory, [*****].

 

1.92.       Safety-Regulatory Agreement” means a document that will outline the responsibilities for safety and regulatory management for the Licensed Product(s) including the exchange of safety information, labeling responsibilities, safety surveillance and signal detection and reporting to Regulatory Authorities in the Territory.

 

1.93.       Second Category” means (a) those certain Indications set forth on Schedule 1.93, [*****].

 

1.94.       Second Indication” means [*****].

 

1.95.       Senior Officer” means, with respect to ACI, its Chief Executive Officer and with respect to Lilly, its Vice-President of Research, Neurodegeneration business unit.

 

1.96.       Specified Limitation” means, [*****].

 

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