Exhibit 10.13
* CONFIDENTIAL TREATMENT REQUESTED.
CONFIDENTIAL PORTION HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION
AMENDMENT NO. 3
TO THE
RESTATED DEVELOPMENT AND
COMMERCIALIZATION
COLLABORATION
AGREEMENT
THIS AMENDMENT NO. 3
(“Amendment”) to that certain Restated Development and
Commercialization Collaboration Agreement dated October 23,
2001 (“Restated Agreement”), is made and entered into
as of September 25, 2006 (“3 rd Amendment Effective Date”), by and between
Otsuka Pharmaceutical Co., Ltd. (“Otsuka”), a
corporation organized and existing under the laws of Japan, having
a principal place of business at 2-9, Kanda Tsukasa-cho,
Chiyoda-ku, Tokyo, 101-8535 Japan, and Bristol-Myers Squibb Company
(“BMS”), a corporation organized and existing under the
laws of Delaware, having a principal place of business at 345 Park
Avenue, New York, New York 10154, USA.
RECITALS
WHEREAS, Otsuka and BMS have
previously entered into the Restated Agreement and an Amendment
No. 1 (dated March 28, 2003) and an Amendment No. 2
(dated June 5, 2003) to the Restated Agreement;
WHEREAS, Otsuka and BMS now desire
to amend certain terms and conditions of the Restated Agreement as
hereinafter specified;
WHEREAS, Otsuka and BMS desire that
all other terms and conditions of the Restated Agreement, as
previously amended, remain in full force and effect;
NOW, THEREFORE, for good and
valuable consideration, the receipt and adequacy of which are
hereby acknowledged, Otsuka and BMS agree as follows:
1. Capitalized terms in this
Amendment shall have the same meanings as those in the Restated
Agreement, unless specifically defined otherwise in this Amendment.
All Section references are in regard to the Restated Agreement.
References to the term “Agreement” in the Restated
Agreement shall be deemed to include this Amendment.
2. Except as expressly modified
herein, the Restated Agreement shall remain in full force and
effect in accordance with its terms, as previously amended. To the
extent that there are any inconsistencies between this Amendment
and the Restated Agreement, as previously amended, the terms of
this Amendment shall supersede the Restated Agreement.
3. In consideration for any exercise
by Otsuka of its rights under Subsection 8.2.2(a) of the Restated
Agreement, as amended by this Amendment, BMS hereby agrees to, and
shall, pay Otsuka the sum of [*] within ten (10) days after
the 3 rd
Amendment Effective Date.
4. Otsuka and BMS hereby amend and
restate Section 8.2 of the Restated Agreement in its entirety
as follows:
8.2 Patent Infringement by Third
Party .
8.2.1 Notice of Infringement
.
If, during the term of this
Agreement, either party becomes aware of any infringement,
threatened infringement or suspected infringement by any third
party of any Patent Rights in the Field in the Territory, such
party shall promptly give written notice thereof to the other
party, with all available details in its possession. The party
involved in any such action or controlling any action under
Section 8.2.2 or 8.2.3 (the “Active Party”) shall,
in each case except as provided to the contrary in Sections 8.2.2
and 8.2.3: (a) keep the other party (the “Inactive
Party”) reasonably informed of the status of the action
including, but not limited to, significant developments during the
pendency of such action; (b) endeavor to solicit the
participation and views of the Inactive Party during each stage of
the action; and (c) reasonably consider such Inactive
Party’s views, although the Active Party’s judgment
shall control.
8.2.2. Remedies Against
Infringement of Patent Rights in the United States .
(a) Otsuka’s First Right to
Pursue Remedies Against Infringement of Patent Rights in the United
States .
(i) With respect to any
infringement, threatened infringement or suspected infringement of
any Patent Rights in the Field in the United States, Otsuka shall
have the first right, but not the obligation, to take action, at
its expense, to pursue any and all remedies against such infringer
to stop such infringement and to recover profits and damages in
connection therewith.
(ii) Pursuant to such right of
Otsuka, in all actions, disputes and proceedings involving Patent
Rights in the United States, Otsuka shall have the sole and
exclusive right to control prosecution of such actions, disputes
and proceedings (including the right to select counsel in
connection therewith) and shall (notwithstanding
Section 8.2.1) have no obligation to keep BMS informed
regarding any such actions, disputes or proceedings or the
prosecution thereof. BMS shall have no right to control, or to
participate in, the decision making process with respect to any
such actions, disputes or proceedings involving the enforcement of
the Patent Rights in the United States, any infringement,
threatened infringement, or suspected infringement of the Patent
Rights in the United States, or the settlement or compromise
thereof. BMS’s consent to the settlement or compromise of any
such action, dispute or proceeding pertaining to the Patent Rights
shall not be required; provided, however, that Otsuka will not
enter into any settlement or compromise of any such action, dispute
or proceeding that requires BMS to pay money to a third party or
that imposes liability on BMS without BMS’s prior written
consent, which BMS shall not unreasonably withhold (such settlement
or compromise being referred to in this Section 8.2.2 and in
Section 8.2.3 as a “Settlement Requiring
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* CONFIDENTIAL TREATMENT REQUESTED.
CONFIDENTIAL PORTION HAS BEEN FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION
BMS Consent”). Otsuka shall
not be required to inform BMS, or to consult with BMS, in respect
of any action, dispute or proceeding, or the settlement or
compromise of any action or dispute, pertaining to the
infringement, threatened infringement or suspected infringement of
the Patent Rights or the enforcement of the Patent Rights in the
United States, except only as and to the extent required above with
respect to a Settlement Requiring BMS Consent. Further, BMS may not
join as a party in any such actions, disputes or
proceedings.
(iii) BMS shall cooperate with
Otsuka as reasonably requested by Otsuka in connection with such
action, dispute or proceeding, shall cause any of BMS’s and
its Affiliates’ employees and agents to give depositions or
testify in connection with any proceeding regarding the Patent
Rights in the United States when requested by Otsuka, and shall
make available to Otsuka copies of any and all relevant records,
papers, documents, information and specimens. BMS shall bear the
out-of-pocket expenses and internal costs incurred by it and its
Affiliates in providing such cooperation to Otsuka at
Otsuka’s request, in causing such employees and agents to
give such depositions or testimony, and in making available copies
of such documents or other materials.
(iv) In the event of any monetary
recovery by Otsuka in connection with any such action, dispute or
proceeding in the United States involving the Patent Rights in the
Field, or the settlement or compromise thereof, such recovery shall
be entirely retained by Otsuka for its own account and
benefit.
(v) In the event that any adverse
judgment for monetary liability is imposed on either Otsuka or any
of its Affiliates in favor of a third-party litigant in any such
action, dispute or proceeding in the United States involving the
Patent Rights in the Field, Otsuka shall bear the entirety of such
adverse judgment.
(b) BMS’s Back-Up Right to
Pursue Remedies Against Infringement of the Patent Rights in the
United States .
(i) With respect to any
infringement, threatened infringement or suspected infringement of
any Patent Rights in the Field in the United States, if
(1) Otsuka decides in writing to BMS not to pursue remedies
against the alleged or suspected infringer(s), and (2) in any
event if Otsuka fails to commence appropriate action with respect
to such infringement within one hundred twenty (120) days
after BMS’s written request to Otsuka to do so, BMS shall
have the right, but not the obligation, to take action in its name,
or in Otsuka’s name where legally required, and at
BMS’s expense, to pursue any and all remedies against such
infringer to stop such infringement and to recover profits and
damages. In any such case, Otsuka shall be entitled, at its own
expense, to join as a party in pursuing such remedies, if legally
permissible. Should Otsuka’s direct participation in the
legal proceedings be indispensable (i.e., it is not legally
permissible for BMS to pursue remedies in Otsuka’s name), BMS
shall be entitled to request Otsuka, at BMS’s expense, to
pursue remedies (which request Otsuka shall not unreasonably
refuse). BMS shall promptly reimburse Otsuka for Otsuka’s
out-of-pocket expenses (but not Otsuka’s internal costs)
reasonably incurred in so participating.
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* CONFIDENTIAL TREATMENT REQUESTED.
CONFIDENTIAL PORTION HAS BEEN FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION
For purposes of determining
BMS’s right to pursue remedies under this Subsection
8.2.2(b), in the event of a “Paragraph IV”
certification under the Hatch-Waxman Act of 1984, if, by the
thirtieth (30th) day following Otsuka’s receipt of the
notice required under 21 U.S.C. § 355(j)(2)(B)(i) and (ii),
Otsuka (A) has not commenced a patent infringement suit
against the putative infringer as contemplated by the relevant
regulations; and (B) has not confirmed to BMS that it intends
to do so within forty-five (45) days of the date of
Otsuka’s receipt of such notice, Otsuka shall be deemed to
have decided not to pursue remedies within the meaning of Clause
(1) above, thereby enabling BMS to pursue remedies under this
Subsection 8.2.2(b).
(ii) Otsuka shall cooperate with BMS
as reasonably requested by BMS in connection with such action,
dispute or proceeding commenced by BMS in accordance with this
Subsection 8.2.2(b), shal
