AMENDMENT NO. 1 TO CO-DEVELOPMENT AND OPTION AGREEMENT
Exhibit 10.1
*** Certain information has been excluded from this agreement because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
AMENDMENT NO. 1
TO
CO-DEVELOPMENT AND OPTION AGREEMENT
This Amendment No. 1 (this “Amendment”) is effective as of February 13, 2023 (the “Amendment Effective Date”) by and between Alector, Inc., a Delaware corporation (“Licensor”), and AbbVie Biotechnology Ltd. (“AbbVie”). Licensor and AbbVie are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”
RECITALS
WHEREAS, the Parties entered into that certain Co-Development and Option Agreement dated October 17, 2017 (the “Agreement”);
WHEREAS, AbbVie issued notice to Licensor of its desire to terminate the CD33 Collaboration Program, which termination was effective on September 30, 2022 pursuant to Section 12.5(b) of the Agreement; and
WHEREAS, the Parties desire to amend the Agreement on the terms set forth herein.
NOW, THEREFORE, in consideration of the premises and the mutual promises and conditions hereinafter set forth, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, do hereby agree as follows.
““Long Term Extension Study” means, with respect to each Collaboration Program, the long term extension trial for such Collaboration Program described in the Pre Exercise Development Plan and Budget.”
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“With respect to the Trem2 Collaboration Program, the PoC Trial Report shall also include all Long Term Extension Study information, Clinical Data and supporting documentation set forth on Schedule 3.1.3, along with any other Long Term Extension Study information as AbbVie may reasonably request in connection with its evaluation, that in each case: (d) is in existence as of the date of the last patient’s last dose in the PoC Trial per the protocol for the PoC Trial, (e) is reasonably accessible to Licensor, (f) is specified in the protocol and statistical analysis plan for the Long Term Extension Study, and (g) is reasonably necessary to make an informed decision as to whether to exercise the Option.”
“[***]”
““New Patient” means, with respect to the Trem2 Collaboration Program, each patient enrolled in the PoC Trial after the [***] patient.””
“As set forth in Section 6.2.7, AbbVie shall pay Licensor in the amount of [***] for the first dosing of each New Patient in the PoC Trial for a Licensed Product containing a Licensed Trem2 Antibody up to a maximum of [***] New Patients.”
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“Licensor shall provide AbbVie a summary report and invoice at the end of each Calendar Quarter listing first dosing visits achieved with respect to New Patients in the PoC Trial within that respective Calendar Quarter. Notwithstanding anything to the contrary contained in Section 6.2 of the Agreement, AbbVie shall pay Licensor within [***] following the receipt of such invoice for any amounts owed under Section 6.2.6; provided, the total amount payable under Section 6.2.6 shall not exceed twelve million five hundred thousand dollars ($12,500,000).”
“Trem2 Interim Analysis. The JSC may decide to include up to [***] interim analysis for the Trem2 Collaboration Program to be performed in accordance with a framework and criteria mutually agreed to by the Parties (the “Interim Analysis Framework”). If such Interim Analysis Framework is agreed by the JSC, the Interim Analysis Framework shall be included in the Pre Exercise Development Plan and Budget, and the performance of such Interim Analysis Framework shall be subject to the terms set forth in Section 3.1.1 and Section 3.1.2.”
“AbbVie shall have the right to exercise its Option with respect to a Collaboration Program by providing written notice of such election to Licensor (the “Option Exercise Notice”) [***] (the “Option Period”).”
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“If to AbbVie, to:
AbbVie Biotechnology Ltd.
Thistle House
0 Xxxxxxx Xxxxxx
Xxxxxxxx XX 11, Bermuda
with a copy (which shall not constitute notice) to:
AbbVie, Inc.
0 X Xxxxxxxx Xxxx
North Chicago, IL 60064
Attention: Vice President, Legal
Facsimile: (000) 000-0000
If to Licensor, to:
000 Xxxxxx Xxxxx Xxxx., Xxxxx 000
South San Francisco, CA 94080
Attention: CEO
with a copy (which shall not constitute notice) to:
Xxxxxx Xxxxxxx Xxxxxxxx & Xxxxxx
000 Xxxx Xxxx Xxxx
Palo Alto, CA 94304
Attention: Xxxxxxx X. Xxxxx
Facsimile: (000) 000-0000”
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THIS AMENDMENT NO. 1 IS EXECUTED by the duly authorized representatives of the Parties as of the Amendment Effective Date.
ABBVIE BIOTECHNOLOGY LTD.
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By: /s/Xxxxx Xxxxxxxxx |
By:/s/Xxxxxx X. Xxxxx |
Name: Xxxxx Xxxxxxxxx |
Name: Xxxxxx X. Xxxxx |
Title: Chief Executive Officer |
Title: Director |
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