Exhibit 10.18(b)

 

[***] Certain information in this document has been excluded pursuant to
Regulation S-K, Item 601(b)(10). Such excluded information is not material and
would likely cause competitive harm to the registrant if publicly disclosed.

 

FIRST AMENDMENT TO LICENSE AGREEMENT

 

This First Amendment (the “First Amendment”), effective as of September 17, 2019
(“Effective Date of the First Amendment”), is made by and between Puma
Biotechnology, Inc., a corporation organized and existing under the laws of
Delaware with its principal place of business at 10880 Wilshire Blvd, Los
Angeles, CA 90024 (“Licensor”) and Pierre Fabre Medicament SAS, a company duly
organized and existing under the laws of France, having offices and principal
place of business at 45, Place Abel Gance 92100 Boulogne Billancourt, France
(“Licensee”) (each individually a “Party” and collectively the “Parties”), and
amends that certain License Agreement between the Parties effective as of March
29, 2019 (the “Agreement”).  Capitalized terms used herein without definition
shall have the meaning set forth in the Agreement.

 

WHEREAS, the Parties desire to amend the provisions of the Agreement relating to
the named patient, temporary use, or similar programs for the Product in the
Licensee Territory (collectively, the “Programs” and each, a “Program”).  

 

NOW THEREFORE, for good and valuable mutual consideration, the receipt and
sufficiency of which is hereby acknowledged, the Parties hereto agree to amend
the Agreement as follows:

 

 

1.

Section 4.6(c)(ii) of the Agreement shall be deleted and replaced with the
following:

 

(ii) Licensor shall maintain Regulatory Filings or approvals for the Product as
existing on or prior to the Effective Date in each country of the Licensee
Territory [***], in consultation with Licensee.  Licensor shall not initiate
Programs in the Licensee Territory after the transfer of the Marketing
Authorization to Licensee without Licensee prior written consent.  Licensor
shall supply all Product requirements for the Programs for each country of the
Licensee Territory [***] until calendar year end [***] in accordance with the
quality agreement for the Programs to be entered into by and among Puma, Pierre
Fabre and Caligor Coghlan Pharma Services (hereinafter referred to as the
“Subcontractor”), provided, such Product requirements shall be met solely
through U.S. commercial supplies and Licensor shall have no obligation under
this Section 4.6(c)(ii) to provide Products in any other supply form.  Title to
the Products intended for the Programs in the Licensee Territory shall pass from
Licensor to Licensee upon delivery at the Subcontractor’s site.

 

2.

Section 4.6(c)(iii) of the Agreement shall be added with the following:

 

(iii)  With respect to any and all Programs, the Parties agree as follows:

 

(A)

Monthly Management Fee: Licensor shall pay for [***] monthly management fees of
the Programs prior to [***]. On or after [***], Licensee shall pay for [***]
monthly management fees for the Programs in the Licensee Territory.

 

 

 

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(B)

New Patient Fee: Licensor shall pay for [***] new patient fees of a Program if
the first Product bottle for a patient enrolled in such Program was delivered to
the patient on or after the Effective Date and prior to the MAH Transfer
Date.  For those Programs in which the first Product bottle for a patient
enrolled in such Program was delivered to the patient on or after the MAH
Transfer Date, Licensee shall pay a one-time fee of $[***] per new patient for
each new patient who enrolls in a Program.

 

 

(C)

Shipping Management Fee: Licensor shall pay for [***] directly related to the
shipping management, that are not Shipping Costs, of the Program Products, prior
to the MAH Transfer Date.  On or after the MAH Transfer Date, Licensee shall pay
$[***] per shipment as shipping management fees, provided the Parties agree to
use reasonable efforts to combine Product shipment.

 

 

(D)

Shipping Costs: Licensor shall pay for [***] shipping costs and expenses
directly related to the shipment of the Products from Licensor’s site to
Subcontractor’s site and from Subcontractor’s site to each patient (“Shipping
Costs”) enrolled in a Program for all initial fills and refills thereafter prior
to the MAH Transfer Date.  On or after the MAH Transfer Date, Licensee shall pay
[***] Shipping Costs for the applicable Program.

 

 

3.

Entire Agreement. All other terms and conditions of the Agreement, as amended
and modified, are hereby ratified, confirmed and approved. This First Amendment
is the integral part of the Agreement. Except as set forth in this First
Amendment, the Agreement is unaffected and shall continue in full force and
effect in accordance with its terms.  If there is a conflict between the
Agreement and this First Amendment, the terms of this First Amendment will
prevail.

 

 

4.

Counterparts. This First Amendment may be executed in one or more counterparts
by the Parties by signature of a person having authority to bind the Party, each
of which when executed and delivered by facsimile, electronic transmission or by
mail delivery, will be an original and all of which shall constitute but one and
the same instrument.

 

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IN WITNESS WHEREOF, the Parties have executed this First Amendment as of the
Effective Date of the First Amendment.

 

 

PUMA BIOTECHNOLOGY, INC.

 

 

 

BY: /s/ Alan Auerbach

NAME: Alan Auerbach

TITLE: Chief Executive Officer and President

 

 

PIERRE FABRE MEDICAMENT SAS

 

 

 

BY: /s/ Jean Luc Lowinski

NAME:  Jean Luc Lowinski

TITLE: President, Pharmaceuticals Division