Exhibit 10.1

 

[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

EXECUTION COPY

Amendment No. 1 to

License Agreement

between

Puma Biotechnology, Inc.

and

Pfizer Inc.

 

 

 

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[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

THIS AMENDMENT NO. 1 TO LICENSE AGREEMENT (the “Amendment”), is entered into and
made effective as of July 18, 2014 (the “Amendment Effective Date”), by and
between Puma Biotechnology, Inc., a corporation organized and existing under the
laws of Delaware with offices at 10880 Wilshire Blvd, Suite 2150, Los Angeles,
CA 90024 (“LICENSEE”) and Pfizer Inc., a corporation organized and existing
under the laws of Delaware and having offices at 235 East 42nd Street, New York,
NY 10017 (“PFIZER”).  LICENSEE and PFIZER may, from time-to-time, be
individually referred to as a “Party” and collectively referred to as the
“Parties.”

Background

Whereas, PFIZER and LICENSEE entered into a License Agreement on August 18, 2011
(the “Agreement”) pursuant to which (i) PFIZER granted to LICENSEE, and LICENSEE
received from PFIZER, certain licenses under certain of PFIZER’s proprietary
technology for the development, manufacture and commercialization of a compound
known as neratinib worldwide and (ii) PFIZER transferred, and LICENSEE assumed,
control of certain Phase III clinical trials of neratinib for the treatment of
cancer;

Whereas, the Parties desire to amend the Agreement to provide (i) that PFIZER
will no longer be responsible for any expenses in conducting the Existing Trials
under Section 3.6 of the Agreement incurred or accrued on or after January 1,
2014, (ii) for a reduction to the royalty rate payable by LICENSEE to PFIZER on
sales of products containing neratinib and (iii) that, though the [***] have
been completed, the Parties will continue to cooperate to effect the transfer to
LICENSEE of any Third Party Contracts as promptly as reasonably practicable.

Now, Therefore, in consideration of the mutual agreements and covenants set
forth herein and other good and valuable consideration, the receipt and
sufficiency of which the Parties hereby acknowledge, the Parties, intending to
be legally bound hereby, agree to the foregoing and as follows:

 

1.

Any capitalized terms used in this Amendment shall have the meaning set forth in
the Agreement, unless otherwise defined herein.

 

2.

Section 1.34 of the Agreement shall be revised to read in its entirety as
follows:

1.34.     “Licensee Trial Cost Cap” means the [***] the out-of-pocket expenses
that LICENSEE may incur between January 1, 2012 and December 31, 2013
(irrespective of when LICENSEE receives the invoices for such expenses) in
conducting the Existing Trials under Section 3.6.  The Parties acknowledge and
agree that any expenses that LICENSEE incurs as a result of [***] will not be
counted towards the Licensee Trial Cost Cap.  In addition, Section 4.4.2 sets
forth certain [***], and Section 4.4.3 sets forth [***].  For the avoidance of
doubt, following December 31, 2013, any expenses incurred or accrued in
conducting

 

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[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

the Existing Trials under Section 3.6 following December 31, 2013 shall be the
sole responsibility of LICENSEE.

 

3.

Section 3.2.2 of the Agreement shall be revised to read in its entirety as
follows:

 

3.2.2.     Unless otherwise agreed upon in writing by the Parties, the
Transition Committee shall meet, in person or by telephone, not less than [***]
after the Transition Committee Identification Date and not less than [***]
thereafter until [***]. In such meetings, the Transition Committee shall (i)
review the progress being made under the Transition Plan and Trial Completion
Plan, and the [***], (ii) discuss future activities to be conducted under the
Transition Plan and Trial Completion Plan, and the [***], and the extent to
which additional resources need to be applied by either Party or both to
complete the transition and achieve trial completion, and (iii) review and agree
upon any necessary or desired revisions to the Transition Plan or Trial
Completion Plan, or the [***].  Upon the request of a Party’s representative on
the Transition Committee, subject to the other Party’s prior consent (not to be
unreasonably withheld or delayed), other personnel from such Party may attend
and participate in such meetings.  It is the objective of the Parties, working
through the Transition Committee, and in accordance with the terms and
conditions of this Agreement including the Schedules hereto, to insure (A) as
smooth and efficient a transition from PFIZER to LICENSEE as reasonably
practical of all relevant documentation, materials, contractual obligations and
regulatory responsibilities related to Products and the Existing Trials and (B)
as smooth and efficient a completion of the Existing Trials as reasonably
practicable, in both cases in accordance with accepted pharmaceutical industry
norms, ethical practices and Applicable Law.

 

4.

Section 3.6.4 of the Agreement shall be revised to read in its entirety as
follows:

3.6.4.     Solely with respect to LICENSEE’s conduct of Trial Completion
Activities with respect to Existing Trials on and after January 1, 2012, PFIZER
will reimburse LICENSEE for Excess Trial Expenses, if any.  “Excess Trial
Expenses” means those out-of-pocket expenses reasonably incurred by LICENSEE
between January 1, 2012 and December 31, 2013 (irrespective of when LICENSEE
receives the invoices for such expenses) that are, in the aggregate, in excess
of the Licensee Trial Cost Cap to conduct such Trial Completion Activities,
excluding any expenses that are [***].  LICENSEE will deliver to PFIZER a
written report within [***] after the end of each Calendar Quarter during which
PFIZER is obligated to reimburse Excess Trial Expenses setting forth in
reasonable detail LICENSEE’s out-of-pocket expenses for the Trial Completion
Activities and the amount, if any, of Excess Trial Expenses to be reimbursed by
PFIZER.  PFIZER will reimburse LICENSEE for applicable Excess Trial Expenses
within [***] after its receipt of such report stating such expenses, with such
back-up information documenting such expenses as PFIZER

 

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[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

may reasonably request, and an invoice for the relevant amount.  Upon execution
of this Amendment, PFIZER shall make a one-time payment to LICENSEE in the
amount of [***].  The Parties acknowledge and agree that such one-time payment
shall discharge PFIZER of any and all further obligations for Excess Trial
Expenses, and LICENSEE releases PFIZER from any and all further obligations for
Excess Trial Expenses.  Notwithstanding the foregoing, PFIZER shall reimburse
LICENSEE for actual payments made after the execution of this Amendment to
clinical trial sites, study investigators and for study subject-related pass
through costs for the Existing Trials (i.e., “pass-through expenses”) that (i)
were incurred on or before December 31, 2013, but not included in the one-time
payment of [***], noted above; (ii) are supported by original invoices; and
(iii) otherwise meet the definition of Excess Trial Expenses.  

 

5.

Section 4.4.3 of the Agreement shall be revised to read in its entirety as
follows:

4.4.3.     To the extent any comparator drugs are required for the Trial
Completion Activities beyond the Comparator Inventory transferred to LICENSEE
pursuant to the Transition Plan, LICENSEE shall be responsible for acquiring
such additional comparator drugs at its own expense; provided that during the
period from the Closing Date through December 31, 2011, if LICENSEE has been
negotiating in good faith with Third Party suppliers of comparator drugs but has
not yet entered into agreements for the supply of comparator drugs with such
Third Parties, then at LICENSEE’s request, PFIZER will use reasonable efforts
upon reasonable notice to order the quantities of comparator drugs for use in
the Existing Advanced Trials requested by LICENSEE in writing, at LICENSEE’s
expense [***]; provided further that via the Transition Committee, the Parties
will discuss necessary lead times and any other activities related to any such
request.

 

6.

Section 5.1.2 of the Agreement shall be revised to read in its entirety as
follows:

5.1.2.     Royalty Payments.  

(a)     In further consideration of the licenses and rights granted to LICENSEE
hereunder, LICENSEE shall pay to PFIZER the royalties set forth below on Net
Sales of Products in the Territory in each Calendar Year during the applicable
Royalty Terms (collectively, “Royalties”).  

 

 

 

NET SALES

ROYALTY RATE

 

 

 

 

Aggregate worldwide Net Sales of all Products

[***] of Net Sales

 

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[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

(b)     LICENSEE shall pay to PFIZER the applicable Royalties within [***]
following the end of each Calendar Quarter after the date of the First
Commercial Sale of a Product.  

 

(c)      In the event that LICENSEE [***] (the “Third Party Patents”), and if
LICENSEE pays [***] under license agreements with such Third Parties [***] (the
“Third Party Payments”), then LICENSEE may credit [***] of such Third Party
Payments against the Royalties owed and payable on the Net Sales for such
Product, as determined on a country-by-country basis.  Notwithstanding the
foregoing, in no event shall such credits reduce the Royalties payable to PFIZER
[***].

 

(d)      All payments shall be accompanied by a report that includes reasonably
detailed information regarding a total monthly sales calculation, on a
country-by-country basis, of Net Sales of each Product (including gross sales
and all Deductions) and all Royalties payable to PFIZER for the applicable
Calendar Quarter (including any foreign exchange rates employed and conversion
calculations).

 

7.

Section 5.2.1 of the Agreement shall be revised to read in its entirety as
follows:

 

5.2.1.     With respect to Net Sales invoiced in U.S. dollars, the Net Sales and
the amounts due for Royalties hereunder will be expressed in U.S. dollars. With
respect to Net Sales invoiced in a currency other than U.S. dollars, such Net
Sales will be converted to U.S. dollars using the average of the applicable
daily foreign exchange rates published in the Wall Street Journal (or any other
qualified source that is acceptable to both Parties) for the last day of each
month of the Calendar Quarter in which such Net Sales occurred, and the amounts
due for Royalties hereunder will be expressed in U.S. dollars. For purposes of
calculating the Net Sales thresholds set forth in [***], the aggregate Net Sales
with respect to each Calendar Quarter within a Calendar Year will be calculated
based on the currency exchange rates for the Calendar Quarter in which such Net
Sales occurred, in a manner consistent with the exchange rate procedures set
forth in the immediately preceding sentence.

 

8.

Section 6.1.1 of the Agreement shall be revised to read in its entirety as
follows:

 

6.1.1.     Relevant Records.  LICENSEE shall keep, and shall cause its
Affiliates and sublicensee to keep accurate financial books and records
pertaining to: LICENSEE’s and its Affiliates’ and sublicensees’ sale of
Products, including any and all calculations of payments due to PFIZER
hereunder; LICENSEE’s prosecution, maintenance and enforcement of Patent Rights;
and during the time PFIZER is obligated to reimburse Excess Trial Expenses,
LICENSEE’s Trial Completion Activities (collectively, “Relevant
Records”).  LICENSEE, its

 

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[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

Affiliates and sublicensees shall maintain the Relevant Records for the longer
of: (a) the period of time required by Applicable Law, or (b) three (3) years
following expiration or termination of this Agreement.  LICENSEE shall require
its sublicensees to provide to LICENSEE copies of all Relevant Records relating
to such sublicensees’ sale of Products as necessary to allow PFIZER to review
such Relevant Records when conducting an audit of LICENSEE pursuant to Section
6.1.2.

 

9.

PFIZER [***].  The Parties hereby agree to add the following as a new Section
4.7:  

 

4.7.      [***]; Transfer of Third Party Contracts. [***]; provided, however,
that the Parties shall continue to cooperate, under the supervision of the
Transition Committee, in a timely manner to effect the transfer to LICENSEE of
any Third Party Contracts in accordance with Schedule B as promptly as
reasonably practicable pursuant to this Agreement.  Such cooperation shall
include, without limitation, the timely execution of all agreements or documents
required in order to effect the transfer of Third Party Contracts for services
performed in relation to the Existing Trials by Third Parties from PFIZER to
LICENSEE.

 

10.

All other terms and conditions of the Agreement shall remain in full force and
effect.

 

11.

This Amendment may be executed in counter-parts 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. Signatures to this Amendment transmitted by facsimile, by email in
“portable document format” (“.pdf”), or by any other electronic means intended
to preserve the original graphic and pictorial appearance of this Amendment
shall have the same effect as physical delivery of the paper document bearing
original signature.

 

12.

This Amendment, together with the Agreement and all Schedules and Exhibits
thereto, constitutes the entire agreement between the Parties as to the subject
matter of this Amendment, and supersedes and merges all prior and
contemporaneous negotiations, representations, agreements and understandings
regarding the same.

 

(Signature page follows.)

 

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[***] INDICATES MATERIAL THAT WAS OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT
WAS REQUESTED. ALL SUCH OMITTED MATERIAL WAS FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE
SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

IN WITNESS WHEREOF, authorized representatives of the Parties have duly executed
this Agreement as of the Effective Date to be effective as of the Effective
Date.

 

Pfizer Inc.

 

Puma Biotechnology, Inc.

 

 

 

 

 

By:

/s/ Garry Nicholson

 

By:

/s/ Alan Auerbach

 

Name: Garry Nicholson

 

 

Name: Alan Auerbach

 

Title: President

 

 

Title: CEO / President