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. 1 TO THE DEVELOPMENT AND LICENSE AGREEMENT
This Amendment No. 1 to the Development and License Agreement (this Amendment) is effective this 25th day of February 2019 (the Amendment 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 as defined in the D&L Agreement); and
WHEREAS, the Parties now desire to amend the D&L 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:
Unless otherwise defined in this Amendment, initially capitalized terms used herein shall have the meanings given to them in the D&L Agreement.
AMENDMENTS TO THE D&L AGREEMENT
2.1 Competing Product. The definition of Competing Product in Article I of the D&L 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 therapeutic product incorporating PTH 1-34 intended for the treatment, prophylaxis or management of any condition resulting from [***] (as shown by course of development or labeling), provided that the NDA for such therapeutic product does not reference the NDA for the Product, but for clarity, such therapeutic product shall not be deemed a Product provided that the NDA for such therapeutic product (TP NDA) does not reference the NDA for the Product, except that Pfenex may reference the NDA for the Product in its TP NDA 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.
2.2 Product. The definition of Product in Article I of the D&L Agreement is hereby deleted in its entirety and replaced with the following:
[***]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.