AMENDMENT NO: 4
[***] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
CONFIDENTIAL
Exhibit 10.43
AMENDMENT NO: 4
TO THE CONTRACT MANUFACTURING AGREEMENT
This Amendment No: 4 to the Contract Manufacturing Agreement (“Amendment 4”) is made effective as of June 15, 2018 (“Amendment 4 Effective Date”) by and between
(1) Alder BioPharmaceuticals, Inc., a company incorporated in Delaware, with its principal office at 00000 Xxxxx Xxxxx Xxxxxxx Xxxxx, Xxxxxxx, XX 00000 X.X.X. (“Alder”), and
(2) Sandoz GmbH, a company incorporated in Austria, with its office at Xxxxxxxxxxxxxxxx 00, X-0000 Xxxxx, Xxxxxxx (“Sandoz”).
WHEREAS
(A) The Parties entered into a Contract Manufacturing Agreement effective as of May 4, 2015 amended by Amendment No. 1 effective September 19, 2016, Amendment No. 2 effective November 17, 2016, Amendment No.3 effective March 31, 2017 (“Amendment 3”), and Amendment No. 3.1 effective December 22, 2017 (collectively, the “Agreement”); and
(B) The Parties wish to amend the Agreement in order to add Schedule 16 to be performed by Sandoz; and
(C) Alder has requested, and Sandoz has agreed, to perform ALD403 Ongoing Process Validation Activities (as defined below) and the Parties wish to amend the Agreement in order to expand the scope of work under the Agreement to include such ALD403 Ongoing Process Validation Activities to be performed by Sandoz;
NOW, THEREFORE, in consideration of the mutual covenants and agreements set forth herein and for other good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, Alder and Sandoz agree as follows:
Capitalized terms used in this Amendment 4, but not otherwise defined, have the meaning ascribed to them in the Agreement.
Amendments:
The Parties agree that the Agreement is amended as follows:
1.Schedule 16:
The Parties agree that the Agreement is amended to include, as Schedule 16, the Schedule 16 that is attached to this Amendment 4, and the “List of Schedules” following the signature page of the Agreement is amended accordingly.
2.Definitions:
The definitions set forth below are added to the Clause 1 (Definitions) of the Agreement:
“ALD403 Ongoing Process Validation Activities” means certain activities required to continuously verify the ALD403 process, such as [***] as described in Clause 2 of Amendment 4 and as further described in Schedule 16, which are “Services” to be performed by Sandoz under this Agreement.
“Amendment 4” means that certain Amendment No: 4 to the Contract Manufacturing Agreement between the Parties dated effective as of June 15, 2018 which amends this Agreement.
3.ALD403 Validation Activities:
The title of Clause 7 of the Agreement is amended from “Validation Lot Campaign (VLC); ALD403 Validation Activities” to “Validation Lot Campaign (VLC); ALD403 Validation Activities including ALD403 Ongoing Process Validation Activities”, and the following Clauses are added to Clause 7:
7.6. (1)Sandoz hereby undertakes to perform the ALD403 Ongoing Process Validation Activities, as described in this Section 7.6(1) and Schedule 16.
7.6.(2) Sandoz shall provide a draft protocol and assessment or monitoring plan for the ALD403 Ongoing Process Validation Activities according to Schedule 16, which shall be reviewed and approved by Alder. After approval of these, Sandoz shall evaluate data of, process parameters and in-process-controls (identified in an assessment and documented in an Ongoing Process Validation protocol); and release data [***]. Upon completion of data evaluation after each ALD403 manufacturing campaign [***], Sandoz shall provide written reports to Alder for Alder’s approval describing in reasonable detail the extent to which the agreed targets, as set out in the ALD403 Ongoing Process Validation Activities protocols, were met.
7.6.(3) In consideration of the performance of the ALD403 Ongoing Process Validation Activities and attainment of the deliverables specified in the relevant protocols or as specified in Schedule 16, Alder shall pay to Sandoz [***] as defined in Schedule 16 [***].
7.6.(4)If Alder cancels the ALD403 Ongoing Process Validation Activities at any time, a cancellation fee of [***] will be charged.
7.6.(5) Invoices for the ALD403 Ongoing Process Validation Activities shall be submitted to Alder upon delivery of certain written draft protocols and reports to Alder according to Clause 7.6.(3).
4.Reference to and Effect on the Agreement.
On and after the Amendment 4 Effective Date, each reference to “this Agreement,” “hereunder,” “hereof,” “herein,” or words of like import shall mean and be a reference to the Agreement as amended hereby. No reference to this Amendment 4 need be made in any instrument or document at any time referring to the Agreement, a reference to the Agreement in any of such instrument or document to be deemed to be a reference to the Agreement as amended hereby.
5.Miscellaneous; Counterparts
All other terms and conditions of the Agreement remain unchanged and are in full force and effect. In the event of any conflict between the terms of this Amendment 4 and the terms of the Agreement, the terms of this Amendment 4 shall control. The Agreement (including the exhibits and schedules attached thereto and referenced therein), as amended by this Amendment 4 (including the schedule attached hereto and referenced herein), constitutes the full understanding of the parties and is the final and complete expression of their agreement with respect to the specific subject matter thereof and hereof, and supersedes any previous or contemporaneous oral or written agreements regarding such subject matter. No modification or alteration of any of the terms of this Amendment shall be of any effect unless in writing, signed by both parties. This Amendment 4 is governed by and shall be construed in accordance with the laws of the State of New York, U.S.A., without regard to the conflict of law principles thereof. This Amendment 4 may be executed in any number of counterparts, each such counterpart shall be deemed to be an original instrument, and all such counterparts together shall constitute but one agreement. Any such counterpart may contain one or more signature pages. This Amendment 4 may be executed by facsimile signature pages.
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[***] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
IN WITNESS WHEREOF, the undersigned have caused this Amendment 4 to be executed and delivered on the date first written above.
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Sandoz GmbH |
Alder BioPharmaceuticals, Inc. |
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Date: |
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By: _________________________ |
By: _________________________ |
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Title: |
Name: Title: |
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Sandoz GmbH |
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Date: |
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By: _________________________ |
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Name: Title: |
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Name:
List of Schedules
Schedule 16ALD403 Ongoing Process Validation Activities (OPV)
[***] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
SCHEDULE 16ALD403 Ongoing Process Validation Activities (OPV)
[***]
[***] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
