CONFIDENTIAL

 

CONFIDENTIAL TREATMENT REQUESTED

UNDER 17 C.F.R.§§ 200.80(B)4, AND 240.24B-2

Exhibit 10.1

 

AMENDMENT No. 1

to the Strategic Collaboration, Option and License Agreement

between Novartis Pharma AG and Akcea Therapeutics, Inc.

 

This Amendment No. 1 (“Amendment”) is entered into as of February 22, 2019
(“Amendment Effective Date”) by and between Novartis Pharma AG, a Swiss
corporation having its principal place of business at Lichtstrasse 35, CH-4056
Basel, Switzerland (“Novartis”), and Akcea Therapeutics, Inc., a Delaware
corporation having its principal place of business at 22 Boston Wharf Road, 9th
Floor, Boston, MA 02210, USA (“Akcea”). Novartis and Akcea are each referred to
individually as a “Party” and together as the “Parties”.

 

WHEREAS, Novartis and Akcea are parties to a Strategic Collaboration, Option and
License Agreement dated as of January 5th, 2017 (the “Agreement”) with respect
to the Development and Commercialization of the Product in the Territory;

WHEREAS, the Parties mutually desire to amend, modify and restate certain terms
and conditions of the Agreement;

NOW THEREFORE, in consideration of the mutual promises contained herein, and for
other good and valuable consideration, the receipt and sufficiency of which are
hereby acknowledged, and intending to be legally bound, the Parties hereto agree
as follows:

1.

DEFINITIONS

Unless otherwise defined herein, capitalized words in this Amendment shall have
the meanings attributed to them in the Agreement.

2.

AMENDMENTS

The Parties agree that, as of the Amendment Effective Date, the Agreement is
amended as set forth in this Section 2.

 

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CONFIDENTIAL

2.1

Section 6.5 of the Agreement is deleted in its entirety and replaced with the
following:

“6.5(A) Akcea’s Right to Co-Commercialize AKCEA-APO(a)-LRx

On or before the [***] calendar day after [***] or [***] for AKCEA-APO(a)-LRx,
whichever is earlier, Novartis shall deliver written notice to Akcea indicating
its election, in Novartis’ sole discretion, to either:

(i)Increase the sales milestones in relation to AKCEA-APO(a)-LRx to the amounts
stated below, whereupon Table 3 in Section 7.5 of the Agreement shall be deleted
in its entirety and replaced with the following:

 

Table 3

Sales Milestone Event for AKCEA-APO(a)-LRx

Milestone Payment

US$[***] in Annual Net Sales

US$[***]

US$[***] in Annual Net Sales

US$[***]

US$[***] in Annual Net Sales

US$[***]

 

For the avoidance of doubt, if Novartis exercises this option (i), Akcea shall
have no right, interest or claim in or to the Co-Commercialization of
AKCEA-APO(a)-LRx and Novartis shall have no obligation to negotiate any such
rights with Akcea; or

(ii)Enter into good faith negotiations with Akcea on the terms and conditions
upon which Akcea will Co-Commercialize AKCEA-APO(a)-LRx, whereby the scope of
such good faith negotiations would be within the following framework:

 

(a)

The countries within the scope of the good faith negotiations for the
Co-Commercialization of AKCEA-APO(a)-LRx shall be the [***], [***] (or, in lieu
of [***]), the [***] and [***] (each a “Co-Commercialization Territory”);

 

(b)

Akcea would have the right to contribute up to [***] percent ([***]%) of the
Novartis FTEs (i.e., [***]) FTEs only) in each Co-Commercialization Territory
(the “Contributed FTEs”);

 

(c)

The Contributed FTEs shall be [***] (i.e., [***] filling positions under [***]
that [***] and were [***] at least [***] ([***]) [***] prior to the [***] for
AKCEA-APO(a)-LRx in the respective Co-Commercialization Territory) and shall
have a comparable level of scientific and/or commercial expertise as the
applicable [***] and[***] in the applicable Co-Commercialization Territory
(e.g., a minimum of [***] ([***]) years’ experience in cardio-metabolic disease
and/or the lipid area);

 

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CONFIDENTIAL

 

(d)

Akcea shall be fully responsible for all [***] of the Contributed FTEs in each
Co-Commercialization Territory;

 

(e)

The Contributed FTEs shall be fully trained in, and comply with, all applicable
Novartis policies and guidelines;

 

(f)

Novartis shall, in its sole discretion, determine in good faith the [***]
between the [***] and [***] and the Contributed FTEs, with consideration being
given to the existing [***] and any existing relationships that may have been
developed around them;

 

(g)

The Contributed FTEs shall meet the performance standards expected of similarly
situated Novartis associates; and

 

(h)

All remaining terms and conditions upon which Akcea will Co-Commercialize
AKCEA-APO(a)-LRx will be negotiated in good faith between the Parties at the
time of such negotiation.

 

6.5 (B) Akcea’s Right to Co-Commercialize AKCEA-APOCIII-LRx.

Akcea has the right to Co-Commercialize AKCEA-APOCIII-LRx with Novartis in
selected markets with the terms and conditions of such Co-Commercialization to
be mutually agreed between Akcea and Novartis.  If, on or before the [***]
calendar day after [***] or [***] for AKCEA-APOCIII-LRx, Akcea delivers written
notice to Novartis indicating that Akcea intends to Co-Commercialize
AKCEA-APOCIII-LRx, then the Parties shall negotiate in good faith on the terms
and conditions upon which Akcea will Co-Commercialize AKCEA-APOCIII-LRx.

3.

INTEGRATION

As specifically amended hereunder, all terms and conditions of the Agreement
remain and shall remain in full force and effect. This Amendment shall hereafter
be incorporated into and deemed part of the Agreement and any future reference
to the Agreement shall include the terms and conditions of this Amendment.

4.

APPLICABLE LAW & JURISDICTION

This Amendment shall be governed by, and construed in accordance with, the laws
which govern the Agreement, and the Parties submit to the jurisdiction and
dispute resolution provisions as set forth in the Agreement.

5.

COUNTERPARTS

This Amendment may be executed in counterparts with the same effect as if both
Parties had signed the same document. All such counterparts shall be deemed an
original, shall be construed together and shall constitute one and the same
instrument. Signature pages of this Amendment may be exchanged by facsimile or
other electronic means without affecting the validity thereof.

 

[Remainder of Page Intentionally Left Blank – Signature Page to Follow]

 

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CONFIDENTIAL

IN WITNESS WHEREOF, the Parties intending to be bound have caused this Amendment
to be executed by their duly authorized representatives.

 

NOVARTIS PHARMA AG

 

AKCEA THERAPEUTICS, INC.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

By:

 

/s/ Neil Johnston

 

By:

 

/s/ Paula Soteropoulos

 

 

 

 

 

 

 

Name:

 

Neil Johnston

 

Name:

 

Paula Soteropoulos

 

 

 

 

 

 

 

Title:

 

Global Head BD&L Pharma

 

Title:

 

CEO

 

 

 

 

 

 

 

Date:

 

 

 

Date:

 

Feb 14, 2019

 

 

 

 

 

 

 

 

 

 

 

 

 

 

By:

 

/s/ Martin Berchtold

 

 

 

 

 

 

 

 

 

 

 

Name:

 

Martin Berchtold

 

 

 

 

 

 

 

 

 

 

 

Title:

 

Senior Legal Counsel

 

 

 

 

 

 

 

 

 

 

 

Date:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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