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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.

 

6.1.2.       Promptly following the Effective Date, the Parties shall negotiate in good faith to establish a commercially reasonable clinical supply agreement and Quality Agreement pursuant to which Lilly would supply ACI with quantities of Licensed Product and placebo for ACI to perform the ACI Pre-Clinical and Phase 1 Activities, provided that Lilly shall supply ACI Licensed Product and placebo at Lilly’s direct out-of-pocket costs and ACI shall not be required to pay for any indirect costs incurred by Lilly, including FTE-related and infrastructure costs. Further, in the event that ACI elects (and Lilly has not finally rejected) to exercise the Unilateral Clinical Development Option, promptly following such election (but in any event within ninety (90) days of such election), the Parties shall enter into a commercially reasonable clinical supply agreement and Quality Agreement pursuant to which Lilly would supply ACI with quantities of Licensed Product and placebo for use by ACI in conducting the applicable Unilateral Activities. Any clinical supply agreement with respect to the Unilateral Clinical Development Option pursuant to the foregoing sentence shall include terms providing for a mutually agreed upon supply price for the supply of Licensed Product and placebo. Any Quality Agreement pursuant to this Section ‎6.1.2 shall set forth the responsibilities and procedures associated with Licensed Compounds or Licensed Products regarding Complaint handling, quality-specific audit rights with respect to compliance with cGMP, and other quality-related matters; provided that, for clarity, to the extent there is any conflict between the terms and conditions of any Quality Agreement and this Agreement with respect to the matters covered by such Quality Agreement, the Quality Agreement shall control.

 

6.2.       Visits to Facilities. Prior to ACI’s completion of the transition of Manufacturing activities from ACI to Lilly, Lilly may conduct a Compliance Audit of ACI or its subcontractors to ensure compliance with applicable GxPs during normal business hours no more than [*****] and upon reasonable advance written notice by Lilly and the mutual written agreement of the Parties as to the specific date and time for such audit.

 

6.3.       Notice of Inspections. Each Party shall provide notice to the other Party within one (1) Business Day of any requested or commenced governmental or regulatory review, audit or inspection of any of its facilities or processes that relate to this Agreement, including any ACI Know-How, ACI Patents, Licensed Compounds or Licensed Products. The Party that is the subject of any such review, audit or inspection shall provide the other Party with the results thereof and provide the other Party with an opportunity to provide assistance to the Party that is the subject of any such review, audit or inspection in responding thereto.

 

6.4.       Manufacturing Technology Transfer. Without limiting the generality of the obligations in Section ‎2.5, ACI shall, promptly following the Effective Date (but in no event later than forty-five (45) days thereafter), transfer to Lilly or its designee (which designee may be an Affiliate, Sublicensee or a Third Party manufacturer) the ACI Know-How relating to the Manufacture of the Licensed Compound, including, for clarity, the then-current process for the Manufacture of the Licensed Compound (the “Manufacturing Process”) and provide such support as may be necessary or reasonably useful to Lilly or its designee to facilitate the practice of Manufacturing Process.

 

ARTICLE 7
PAYMENTS AND RECORDS

 

7.1.       Upfront Payment. In partial consideration of the rights granted by ACI to Lilly hereunder and subject to the terms and conditions of this Agreement, no later than thirty (30) days following the Effective Date, Lilly shall pay ACI a nonrefundable, noncreditable upfront amount equal to eighty million Swiss Francs (CHF 80,000,000).

 

7.2.       Milestones.

 

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