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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 connectio


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