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.

 

1.39.       First Category” means [*****].

 

1.40.       First Commercial Sale” means, [*****].

 

1.41.       First Indication” means [*****].

 

1.42.       FTE” means the equivalent of the work of one (1) employee full time for one (1) Calendar Year [*****] of work directly related to the Development of a Licensed Product. No additional payment shall be made with respect to any person who works [*****] and any person who devotes [*****] (or such other number as may be agreed by the JSC) shall be treated as an FTE on a pro rata basis based upon [*****].

 

1.43.       FTE Costs” means [*****].

 

1.44.       FTE Rate” means [*****].

 

1.45.       GAAP” means, with respect to a Party or its Affiliates or its or their Sublicensees, United States generally accepted accounting principles, International Financial Reporting Standards or such other similar national standards as such Party, Affiliate or its or their Sublicensee adopts, in each case, consistently applied.

 

1.46.       Generic Product” means, with respect to a Licensed Product, any pharmaceutical product that (i) contains an active ingredient the same as or similar to the Licensed Compound in such Licensed Product, (ii) is distributed by a Third Party which is not a Sublicensee or Affiliate thereof under a Drug Approval Application approved by a Regulatory Authority (a) in the U.S. pursuant to Section 505(b)(2) or Section 505(j) of the FFDCA (21 U.S.C. 355(b)(2) and 21 U.S.C. 355(j), respectively), (b) in the EU pursuant to a provision of Articles 10, 10a or 10b of Parliament and Council Directive 2001/83/EC as amended (including an application under Article 6.1 of Parliament and Council Regulation (EC) No 726/2004 that relies for its content on any such provision) or (c) in any other country or jurisdiction pursuant to all equivalents of such provisions based on a demonstration of bioequivalence or similarity to such Licensed Product and in reliance, in whole or in part, on the prior approval (or on safety or efficacy data submitted in support of the prior approval) of such Licensed Product, and (iii) may be substituted under Applicable Law as a therapeutic equivalent to such Licensed Product when dispensed without the intervention of a physician or other health care provider with prescribing authority.

 

1.47.       “Good Clinical Practices” or “cGCP” means the then-current standards for clinical trials for pharmaceuticals, as set forth in the FFDCA or other Applicable Law, and such standards of good clinical practice as are required by the Regulatory Authorities of the United States and European Union and other organizations and Governmental Authorities in countries for which any Licensed Product is intended to be Developed, to the extent such standards are not less stringent than United States Good Clinical Practices.

 

 7


© AC Immune 2015