[***] = 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 11804 North Creek Parkway South, Bothell, WA 98011 U.S.A.
(“Alder”), and

(2) Sandoz GmbH, a company incorporated in Austria, with its office at
Biochemiestrasse 10, A-6250 Kundl, Austria (“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.

[the remainder of this page has been intentionally left blank]

[***] = 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.

 

--------------------------------------------------------------------------------

 

 

[gs2pap5s1u0e000001.jpg]IN WITNESS WHEREOF, the undersigned have caused this
Amendment 4 to be executed and delivered on the date first written above.

 

Sandoz GmbH

Alder BioPharmaceuticals, Inc.

 

Date:

 

Date:

 

By:       _________________________

 

By:       _________________________

[gs2pap5s1u0e000002.jpg]Name:

Title:

Name:

Title:

 

 

 

 

Sandoz GmbH

[gs2pap5s1u0e000003.jpg]

 

Date:

 

 

 

By:       _________________________

 

Name:

Title:

 

 

 

 

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.