Exhibit 10.48

 

[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

THIRD AMENDMENT TO COLLABORATION AND LICENSE AGREEMENTS

 

This Amendment to Collaboration and License Agreements (the “Amendment”) is
entered into on November 7, 2011 (the “Amendment Effective Date”) between
AFFYMAX, INC., a Delaware corporation, with its principal place of business at
4001 Miranda Avenue, Palo Alto, CA  94304, U.S.A. (“Affymax”), and TAKEDA
PHARMACEUTICAL COMPANY LIMITED, a company incorporated under the laws of Japan,
with its principal place of business at 1-1, Doshomachi 4-chome, Chuo-ku, Osaka,
540-8645, Japan (“Takeda”).

 

RECITALS

 

WHEREAS, Affymax and Takeda have entered into a certain Collaboration and
License Agreement dated as of February 13, 2006, under which Affymax has granted
Takeda a certain right and license for the development and commercialization in
Japan of Affymax’s proprietary pegylated dipeptide drug candidate designated by
Affymax as Hematide™ (as amended by the First Amendment, dated April 1, 2007 and
the Second Amendment, dated January 1, 2008, the “Japan Agreement”);

 

WHEREAS, Affymax and Takeda have also entered into another Collaboration and
License Agreement dated as of June 27, 2006, under which Affymax has granted
Takeda a certain right and license for the development and commercialization of
the same drug candidate worldwide outside Japan (as amended by the First
Amendment, dated April 1, 2007 and the Second Amendment, dated January 1, 2008,
the “Global Agreement”; together with the Japan Agreement, the “Agreements”);

 

WHEREAS, Affymax and Johnson & Johnson and its affiliates (expressly including,
but not limited to, Johnson & Johnson Pharmaceutical Research and Development,
LLC, Ortho-McNeil-Janssen Pharmaceuticals, Inc., Ortho-McNeil Pharmaceuticals,
LLC, Ortho-McNeil Pharmaceutical, Inc., Ortho Pharmaceutical Corporation, R.W.
Johnson Pharmaceutical Research Institute, and Janssen Biotech, Inc.)
(collectively, “Ortho”) are entering into concurrently herewith a settlement
agreement, whereby Ortho covenants not to sue Affymax with respect to activities
constituting the making, having made, importing, using, selling, and offering
for sale throughout the world of peginesatide (formerly known as Hematide),and
grants Affymax a license to make, have made, import, use, sell, and offer for
sale throughout the world peginesatide (and with respect to the peginesatide
component of all products containing peginesatide), under any and all rights in
the Arbitration Patents (as defined therein) in exchange for certain financial
commitments (the “Settlement Agreement”), attached hereto as Exhibit A; and

 

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WHEREAS, Affymax and Takeda would like to amend the Agreements to modify the
ongoing financial commitments of the Parties in light of the Settlement
Agreement.

 

NOW THEREFORE, in consideration of the foregoing premises and mutual promises,
covenants and conditions contained in this Amendment, the Parties agree as
follows:

 

 

1.              Settlement Agreement Acknowledgement.  Takeda expressly
acknowledges all provisions and, as a sublicensee of Affymax under the
Agreements, shall have the benefits set forth in the Settlement Agreement. 
Takeda shall comply with the provisions of the Settlement Agreement to the
extent applicable to its activities as sublicensee of Affymax under the
Agreements; provided, however, Takeda shall have no payment obligations under
the Settlement Agreement.  Takeda’s sole obligation to make any payments with
respect to the Settlement Agreement are set forth exclusively in this Third
Amendment.

 

2.              Addition of New Section 8.2(b) of the Global Agreement.  The
Parties hereby agree to append, at the end of Section 8.2 of the Global
Agreement, new Section 8.2(b) as follows:

 

8.2(b)     Notwithstanding Sections 9.13 and 9.6(d) (and Section 8.6(b) related
thereto) of this Agreement and Section 8.4 and 9.6 of the Japan Agreement and as
the allocation between the Parties with respect to payments due or otherwise
payable under such provisions with respect to the Ortho Patents, as a result of
Affymax’s financial obligations pursuant to the Settlement Agreement, the
Parties agree that Takeda shall make the following non-refundable,
non-creditable milestone payments to Affymax once and only once based on the
first achievement of each milestone event in the Licensed Territory for the
Product as set forth in this Section 8.2(b).  For clarity, the milestone
payments set forth in this Section 8.2(b) shall be in addition to the other
milestone payments in Section 8.2. Specifically, Takeda shall pay to Affymax the
amounts set forth below within thirty (30) days after the first achievement of
the corresponding milestone event with respect to the Product.  Each such
payment shall be made by wire transfer of immediately available funds into an
account designated by Affymax.

 

Milestone Event

 

Milestone Payment

 

[ * ]:

 

 

 

[ * ]

 

$

[ * ]

 

[ * ]

 

$

[ * ]

 

Upon the [ * ](1)

 

$

[ * ]

 

Total Milestone Payments under 8.2(b)

 

$

[ * ]

 

 

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[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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(1) For purposes of this milestone event, [ * ].

 

3.              Acknowledgement and Reports. The Parties acknowledge and agree
that the payments pursuant to the Settlement Agreement including the royalties
thereunder shall be the sole responsibility of Affymax; provided, however, that
(1) Takeda covenants and agrees to make timely payments as required under the
Agreements, as amended, and (2) Affymax shall utilize any amounts received from
Takeda under the Agreements, as amended, to first make payments to Ortho
required under the Settlement Agreement if then due to Ortho before utilizing
such amounts for any other purpose.  In the event that Affymax requires
additional information within the Royalty Territory (e.g. breakdown of royalty
calculations for certain territories) from Takeda other than as set forth in
Section 8.5(c) in order to calculate or fulfill its obligations to Ortho under
the Settlement Agreement, Takeda shall reasonably cooperate with Affymax in that
regard.

 

4.              Patent Challenges.  During the term of the Agreements, as
amended, Takeda, as sublicensee of Affymax, agrees not to initiate, assert or
assist in any further challenge to the patentability, validity, and
enforceability of the Arbitration Patents (as defined in the Settlement
Agreement), including all challenges to the continued prosecution of the
Arbitration Patents in any patent office anywhere in the world

.

 

5.              Counterparts.  This Amendment may be executed in counterparts,
each of which shall be deemed an original, but both of which together shall
constitute one and the same instrument. Upon execution and delivery of this
Amendment, each of the Japan Agreement and Global Agreement shall be deemed
amended as though effective separately for each.

 

6.              Continuing Effect.  Other than as set forth in this Amendment,
all of the terms and conditions of the Japan Agreement and Global Agreement,
respectively, shall continue in full force and effect.  All capitalized terms
not otherwise defined herein shall have the meanings ascribed to them in the
Agreements, as applicable.

 

7.              Severability.  If any provision of this Amendment or the
application thereof is held invalid, the invalidity shall not affect other
provisions or applications of this Amendment which can be given effect without
the invalid provisions or application, and to this end the provisions of this
Amendment are declared to be severable.

 

[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]

 

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[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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IN WITNESS WHEREOF, the Parties have executed this Amendment in duplicate
originals by their duly authorized officers as of the Amendment Effective Date.

 

 

TAKEDA PHARMACEUTICAL COMPANY LIMITED

AFFYMAX, INC.

 

 

 

 

By:

/s/ Yoichi Okumura

 

By:

/s/ John Orwin

Name:

Yoichi Okumura

 

Name:

John Orwin

Title:

General Manager

Title:

CEO

 

Intellectual Property Department

 

 

 

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[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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EXHIBIT A

 

SETTLEMENT AGREEMENT

 

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[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY
BRACKETS, IS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

 

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