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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.

 

1.13.3.       such Party sells or transfers to any Third Party, in one or more related transactions, properties or assets representing all or substantially all of such Party’s consolidated total assets; or

 

For the purpose of this definition of Change of Control: (i) “person” and “group” have the meanings given such terms under Section 13(d) and 14(d) of the United States Securities Exchange Act of 1934 and the term “group” includes any group acting for the purpose of acquiring, holding or disposing of securities within the meaning of Rule 13d-5(b)(1) under the aforesaid Act; (ii) a “beneficial owner” shall be determined in accordance with Rule 13d-3 under the aforesaid Act; and (iii) the terms “beneficially owned” and “beneficially own” shall have meanings correlative to that of “beneficial owner.”

 

1.14.       CHF” means Swiss Francs.

 

1.15.        Clinical Trial” means a human clinical trial designed to evaluate the safety, efficacy, tolerability or appropriate dosage of a Licensed Product, as the context requires, including Phase 1 Clinical Trials, Phase 2 Clinical Trials or Phase 3 Clinical Trials.

 

1.16.       CMC” means, chemistry, Manufacturing and controls with respect to a product, which includes (i) Manufacturing process development records for such product, (ii) all chemistry, Manufacturing and control procedures necessary for the Manufacture of such product, and (iii) sourcing and testing of all raw materials and components used in the Manufacture of such product.

 

1.17.       Commercialization” means, with respect to any product, any and all activities directed to the preparation for sale of, offering for sale of or sale of such product, including activities related to marketing, promoting, distributing and importing such product, and interacting with Regulatory Authorities regarding any of the foregoing. When used as a verb, “to Commercialize” and “Commercializing” mean to engage in Commercialization and “Commercialized” has a corresponding meaning.

 

1.18.       Commercially Reasonable Efforts” means with respect to the performance of activities with respect to any Licensed Compound or Licensed Product by a Party, [*****].

 

1.19.       Complaint” means a customer's written, oral or electronic communication that alleges deficiencies related to the identity, quality, purity, durability, reliability, safety, or effectiveness or performance of a distributed drug product, drug/device combination product, medical device, animal health premix, API (active pharmaceutical ingredient), process intermediate or fermentation product. Complaints include: Adverse Events, adverse drug experiences, adverse drug reactions, company identified reportable malfunctions (CIRM), lack of drug effect (LODE) and product complaints.

 

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