Exhibit 10.1

 

AMENDMENT NO. 1

TO EXCLUSIVE LICENSE AGREEMENT

 

 

This Amendment No. 1 (this “Amendment”) to the Exclusive License Agreement,
dated July 27, 2017 (the “Agreement”), between TESARO, Inc. (“TESARO”) and
Millennium Pharmaceuticals, Inc., a wholly-owned subsidiary of Takeda
Pharmaceutical Company Ltd. (“Licensee”), is entered into as of July 16, 2018
(“Amendment Effective Date”).  TESARO and Licensee are sometimes referred to
herein individually as a “Party” and together as the “Parties”.  Capitalized
terms used but not otherwise defined in this Amendment shall have the same
meaning as set forth in the Agreement.

 

WHEREAS, the Parties desire to amend the Agreement to expand the Licensed
Territory on a limited basis to enable Licensee to make initial regulatory
filings in the newly added countries pending the Parties mutual agreement on
Licensee’s support for TESARO’s obligations under the Janssen Agreement; and

 

WHEREAS, the Parties wish to negotiate in good faith the process and conditions
according to which Licensee will support TESARO to comply with its obligations
under the Janssen Agreement in any country or jurisdiction of the Licensed
Territory (other than Japan) (the “Janssen Shared Countries”).

 

NOW, THEREFORE, in consideration of the foregoing premises and the mutual
convenants herein contained, the Parties hereby agree as follows:

 

1.Amendments to the Agreement.  The Parties agree that, effective as of the
Effective Amendment Date, the Agreement is amended as follows:

 

a.Expansion of Licensed Territory.  Sections 1.46 and 1.49 of the Agreement are
replaced in their entirety with the following:

 

“Section 1.41a‘Janssen’s Field’ means the diagnosis, treatment or prevention of
prostate cancer in humans.”

 

“Section 1.46‘Licensed Field’ means (a) in Japan, the treatment, diagnosis and
prevention of any disease or conditions in humans, and (b) in the remaining
countries of the Licensed Territory other than Japan, the treatment, diagnosis
and prevention of any disease or conditions in humans, other than the treatment,
diagnosis and prevention of prostate cancer.”

 

“Section 1.49‘Licensed Territory’ means (a) Japan, South Korea, Taiwan, Russia,
Australia, (b) Armenia, Belarus, Kazakhstan and Kyrgyzstan (the “Regulatory Only
Countries”), provided that Licensee shall not have any Commercialization rights
and

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obligations in respect of the Regulatory Only Countries unless and until the
Parties reach mutual agreement on Licensee’s support for TESARO’s compliance
with its obligations under the Janssen Agreement in the Janssen Shared Countries
in accordance with Section 6.6.1a, and (c) such additional countries as may from
time to time be added upon mutual written agreement of the Parties.”

 

For any avoidance of doubt and solely for the purpose of applying this
Amendment, if and to the extent applicable to any and all provisions contained
in the Agreement, the “Effective Date” therein shall read the “Amendment
Effective Date”.

 

b.Janssen Agreement. A new Section 6.6.1a shall be added to the Agreement as
follows:

 

“Licensee is informed with respect to certain of TESARO`s obligations under the
Janssen Agreement (a true and correct copy of which (other than certain redacted
financial terms) has been provided by TESARO to Licensee), particularly
concerning TESARO`s obligations for:  (i) regulatory activities related to
Janssen’s prostate filings in accordance with Section 5.3 of the Janssen
Agreement: (ii) distribution and supply activities in accordance with Section
6.2 of the Janssen Agreement; and (iii) revenue allocation related to prostate
and non-prostate sale in accordance with Section 8.3 of the Janssen Agreement.
TESARO and Licensee agree to continue negotiations in good faith with the aim to
agree and define the process and conditions according to which Licensee will
support TESARO to comply with its obligations under the Janssen Agreement,
including the aforementioned sections. For the avoidance of doubt, unless and
until the Parties reach such mutual agreement, Licensee shall not have any
Commercialization rights or obligations in any of the Regulatory Only Countries,
other than as set forth in the Agreement as amended by this Amendment No. 1.”

 

2.Miscellaneous.  Except as modified in this Amendment, the remainder of the
Agreement shall remain in full force and effect.  Section 10.4 (Arbitration) and
Section 10.8 (Governing Law) shall apply mutatis mutandis to this Amendment.
This Amendment may be executed in one or more counterparts, each of which will
be deemed an original, and all of which together will be deemed to be one and
the same instrument.  Signatures to this Amendment transmitted by facsimile
transmission, by electronic mail in “portable document format” (“.pdf”) form, or
by any other electronic means intended to preserve the originals graphic and
pictorial appearance of a document, will have the same effect as physical
delivery of the paper document bearing the original signatures, and shall be
deemed original signatures by both Parties.

 

[Signatures follow on next page]

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

 

 

 

 

 

 

TESARO, INC.

MILLENNIUM PHARMACEUTICALS, INC.

 

 

 

 

 

 

By:

/s/ Mary Lynne Hedley

    

By:

/s/ Christophe Bianchi

 

(duly authorized signatory)

 

 

(duly authorized signatory)

 

 

 

 

 

 

Mary Lynne Hedley

 

 

Christophe Bianchi

 

 

 

 

 

 

President & Chief Operating Officer

 

 

President, Global Oncology Business Unit

 

 

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