Exhibit 10.4

 

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT HAS BEEN OMITTED
BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF
PUBLICLY DISCLOSED. INFORMATION THAT HAS BEEN OMITTED HAS BEEN NOTED IN THIS
DOCUMENT WITH A PLACEHOLDER IDENTIFIED BY THE MARK “[***]”.

 

AMENDMENT NO. 2 TO THE DEVELOPMENT AND LICENSE AGREEMENT

 

This Amendment No. 2 to the Development and License Agreement (this “Amendment
#2”) is effective this 24th day of June, 2020 (the “Amendment #2 Effective
Date”) by and between Pfenex Inc., a Delaware corporation (“Pfenex”), and
Alvogen Malta Operations Ltd., a Maltese corporation (“Alvogen”). Pfenex and
Alvogen are sometimes collectively referred to herein as the “Parties” and
separately as a “Party.”

 

WHEREAS, pursuant to that certain Development and License Agreement made as of
June 11, 2018 by and between the Parties (the “D&L Agreement”), Pfenex granted
to Alvogen an exclusive right to develop, manufacture and Commercialize Product
in the Territory (each capitalized term as defined in the D&L Agreement);

 

WHEREAS, the Parties subsequently amended the D&L Agreement on February 25, 2019
(“First Amendment”), which along with the D&L Agreement shall collectively be
referred to as the “Development Agreement”; and

 

WHEREAS, the Parties now desire to further amend the Development Agreement as
set forth

below.

 

NOW, THEREFORE, in consideration of the mutual covenants, agreements and
stipulations

set forth herein, the receipt and legal sufficiency of which are hereby mutually
acknowledged, the Parties hereby agree as follows:

 

ARTICLE I DEFINITIONS

 

Unless otherwise defined in this Amendment #2, initially capitalized terms used
herein shall have the meanings given to them in the Development Agreement.

 

ARTICLE II

AMENDMENTS TO THE DEVELOPMENT AGREEMENT

 

2.1Competing Product. The definition of “Competing Product” in Article I of the
Development Agreement is hereby deleted in its entirety and replaced with the
following:

 

““Competing Product” means, on a country-by-country basis in the Territory, (a)
the Reference Product, (b) a therapeutic product other than the Product that
contains the active pharmaceutical ingredient of the Reference Product
(including the Drug Substance or a modified or derivative version thereof) as
its sole active pharmaceutical ingredient or (c) any revised formulation,
strength, presentation or delivery method of any product described in (a) or
(b), where the Regulatory Materials with respect thereto reference or would be
required to reference the Reference Product, in the case of (c), to the extent
such product is labeled for use for the same indication as the Reference Product
as of the Effective Date. For clarity, Competing Product excludes any

 

[***] Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would be
competitively harmful if publicly disclosed.

 

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

 

 

 

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT HAS BEEN OMITTED
BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF
PUBLICLY DISCLOSED. INFORMATION THAT HAS BEEN OMITTED HAS BEEN NOTED IN THIS
DOCUMENT WITH A PLACEHOLDER IDENTIFIED BY THE MARK “[***]”.

 

 

 

therapeutic product [***] (as shown by course of development or labeling, any a
“TP Product”) and in no event will TP Product be deemed a Product provided that
the NDA for such TP Product (any, a “TP NDA”) does not reference the NDA for the
Product other than a TP NDA may reference Module 2 Sections 2.3a and 2.3s and
Module 3 Sections 3.2.s (3.2.S.1- 3.2.S.7) of the NDA, and relevant supportive
documents, for the Product to the extent needed to use cell banks, production
processes or supporting analytical methods that were conceived, generated or
reduced to practice in the course of developing the Product (collectively, the
“Manufacturing Info”). Accordingly, at Pfenex’s request, Alvogen shall provide
to Pfenex a copy of the Manufacturing Info (including any update thereto) and/or
the authorization to reference the same for a TP NDA (or similar regulatory
filing inside or outside the Territory).”

 

 

2.2

Support Payments. Section 4.2(d) is hereby added to the Development Agreement as
follows:

 

“(d) In support of the Drug Substance tech transfer described in Section 5.2(d),
Pfenex shall pay to Alvogen the following milestone payments:

 

[***]

 

The above sections 4.2(d)(i)-(iii) notwithstanding, Pfenex’s payments for the
relevant time period (from the Amendment #2 Effective Date until September 1,
2020 for Section 4.2(d)(i), between September 2, 2020 and March 1, 2021 for
Section 4.2(d)(ii), and between March 2, 2021 and March 1, 2022 for Section
4.2(d)(iii)) shall not exceed [***] of the tech transfer costs actually paid by
Alvogen to [***], for such relevant time period. If the payment of any one of
4.2(d)(i)-(iii) exceeds fifty percent (50%) of the [***] for the relevant time
period, such payment shall be adjusted down to equal [***] of the actual tech
transfer costs incurred by Alvogen as of the payment date, with the remaining
sums owed under any one of 4.2(d)(i)-(iii) to be paid once the milestone payment
in 4.2(d)(i), 4.2(d)(ii), or 4.2(d)(iii) is equal to or less than [***] of the
actual tech transfer costs paid by Alvogen to [***].”

 

 

2.3

Drug Substance Tech Transfer. Section 5.2(d) is hereby added to the Development
Agreement as follows:

 

 

“(d) Alvogen and Pfenex agree to jointly tech transfer the Drug Substance
manufacturing to [***], in accordance with the terms of this Agreement. Pfenex,
at its own cost and expense, shall provide primary technical, analytical and
process support for the tech transfer, with Alvogen providing secondary support
as needed at its own cost and expense. Alvogen, at its own cost and expense,
shall provide primary project management, quality and regulatory support for the
tech transfer, with Pfenex providing secondary support as needed at its own cost
and expense.”

 

 

[***] Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would be
competitively harmful if publicly disclosed.

3

 

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CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT HAS BEEN OMITTED
BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF
PUBLICLY DISCLOSED. INFORMATION THAT HAS BEEN OMITTED HAS BEEN NOTED IN THIS
DOCUMENT WITH A PLACEHOLDER IDENTIFIED BY THE MARK “[***]”.

 

 

2.4

Drug Substance Supply. Section 5.2(e) is hereby added to the Development
Agreement as follows:

 

 

“(e) Alvogen shall supply Drug Substance to Pfenex [***] to procure the Drug
Substance from [***], along with prorated costs for transportation and storage
of the Drug Substance without mark-up by Alvogen for as long as Pfenex is
directly Commercializing the TP Product. Pfenex shall pay Alvogen for Drug
Substance received within thirty (30) days of receiving an invoice for delivery.
If Alvogen decides, at its own discretion, to no longer Commercialize Product,
or manufacture Drug Substance, then Alvogen shall seek to amend the [***]
manufacturing agreement to permit Pfenex to directly order Drug Substance from
[***] at a price agreed upon between Pfenex and [***].”

 

ARTICLE III GENERAL

 

 

3.1

No Other Modifications. Except as specifically set forth in this Amendment #2,
the terms and conditions of the Development Agreement shall remain in full force
and effect. No waiver, alteration or modification of any of the provisions of
this Amendment #2 shall be binding unless made in writing and signed by the
Parties by their respective officers thereunto duly authorized. The waiver by
either Party of a breach or a default of any provision of this Amendment #2 by
the other Party shall not be construed as a waiver of any succeeding breach of
the same or any other provision, nor shall any delay or omission on the part of
either Party to exercise or avail itself of any right, power or privilege that
it has or may have hereunder operate as a waiver of any right, power or
privilege by such Party.

 

 

 

3.2

Miscellaneous. This Amendment #2 may be executed in any number of counterparts,
each of which shall be deemed an original but all of which together shall
constitute one and the same instrument. This Amendment #2 once executed by a
Party may be delivered via electronic means of transmission and shall have the
same force and effect as if it were executed and delivered by the Parties in the
presence of one another. This Amendment #2 shall be governed by and construed in
accordance with the laws of the State of New York, United States without regard
to its conflicts of laws principles.

 

 

[Remainder of page intentionally left blank]

 

 

[***] Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would be
competitively harmful if publicly disclosed.

4

 

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

 

 

 

CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT HAS BEEN OMITTED
BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF
PUBLICLY DISCLOSED. INFORMATION THAT HAS BEEN OMITTED HAS BEEN NOTED IN THIS
DOCUMENT WITH A PLACEHOLDER IDENTIFIED BY THE MARK “[***]”.

 

 

 

 

IN WITNESS WHEREOF, the Parties hereto have caused this Amendment #2 to be
executed as of the Amendment #2 Effective Date by their duly authorized
representatives.

 

PFENEX INC.

 

By: /s/ Eef Schimmelpennink Name: Eef Schimmelpennink Title:   CEO

 

 

ALVOGEN MALTA OPERATIONS LTD.

 

 

By: /s/ Mark Edwards Name: Mark Edwards                 Title:   Sr. Director,
U.S. Supply Chain

 

[***] Certain confidential information contained in this document, marked by
brackets, has been omitted because it is both (i) not material and (ii) would be
competitively harmful if publicly disclosed.

5