Exhibit 10.3

 

CONFIDENTIAL TREATMENT

 

AMENDMENT TO LICENSE AGREEMENT

 

This Amendment is hereby made and effective as of March 1, 2013 (the “Amendment
Effective Date”) by and between:

 

Astellas Pharma Inc., a company organized and existing under the laws of Japan,
having its registered office at 3-11, Nihonbashi-Honcho 2-chome, Chuo-ku, Tokyo
103-8411, Japan (“Astellas”); and

 

Calixa Therapeutics, Inc., a company organized and existing under the laws of
the State of Delaware, having its principal place of business at 65 Hayden
Avenue, Lexington, MA 02421, USA (“Calixa”).

 

RECITALS

 

A.                                    Astellas and Calixa entered into a certain
License Agreement as of November 1, 2007, as amended (the “Agreement”) relating
to the pharmaceutical compound known as ceftolozane (formerly CXA-101;
FR264205); and

 

B.                                    Cubist Pharmaceuticals, Inc. (“Cubist”)
acquired Calixa in 2010, and Calixa is now a wholly-owned subsidiary of Cubist;
and

 

C.                                    As a result of recent discussion, Astellas
and Calixa desire to amend the Agreement in accordance with the terms and
conditions provided herein.

 

NOW, THEREFORE, Astellas and Calixa hereby agree to amend the Agreement as
follows:

 

1.                          Unless otherwise expressly provided in this
Amendment, all definitions in the Agreement shall be also applicable to this
Amendment.

 

2.                          In consideration of the amendments contained herein,
Calixa shall make to Astellas within thirty (30) days after the Amendment
Effective Date a one-time payment of twenty-five million US dollars
(US$25,000,000).

 

3.                          A new Section 1.9A shall be added to the Agreement,
as follows:

 

“1.9A “New Territory” shall mean Japan, Taiwan, South Korea, China (mainland),
Hong Kong, Macau, Thailand, Indonesia, the Philippines, Australia, New
Zealand, India, Saudi Arabia, Kuwait, Oman, Qatar, United Arab Emirates, Bahrain
and Yemen.”

 

In each place in the Agreement that the word “Territory” appears, the words “and
the New Territory” shall be added immediately thereafter.

 

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*Confidential Treatment Requested.  Omitted portions filed with the Securities
and Exchange Commission (the “Commission”).

 

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4.                          Sections 2.1 and 2.2 of the Agreement shall be
deleted in its entirety and replaced by the following, and the following new
Sections 2.3, 2.4, 2.5 and 2.6 shall be inserted thereafter:

 

“2.1 Astellas hereby grants to Calixa the exclusive license, with the full
rights to grant sublicenses to its Affiliates and to Third Parties through
multiple tiers (subject to Sections 2.2, 2.3, 2.4, 2.5 and 2.6), under the
Product Patents and all the Know-How of Astellas and its Affiliates to develop,
manufacture, have manufactured, use, import, market, promote, sell, offer to
sell and distribute the Products in the Territory and the New Territory. 
Astellas hereby grants to Calixa the non-exclusive license, with the full rights
to grant sublicenses to its Affiliates and to Third Parties through multiple
tiers (subject to Sections 2.2, 2.3, 2.4, 2.5 and 2.6), under the Related
Patents to develop, manufacture, have manufactured, use, import, market,
promote, sell, offer to sell and distribute the Products in the Territory and
the New Territory, provided that such non-exclusive license shall be effective
as far as Astellas has the ability to grant such license.

 

2.2 If Calixa intends to grant a sublicense to its Affiliate or any Third Party,
it shall use reasonable efforts to assure itself that the prospective
sublicensee has the ability to perform the obligations of Calixa under this
Agreement that would be sublicensed to such sublicensee.  If Calixa grants a
sublicense to such Affiliate or Third Party, it shall identify in writing to
Astellas the Affiliate or the Third Party and the extent of the rights that
Calixa has granted a sublicense under the license rights granted in Section 2.1
above.  Calixa shall ensure that: (i) any sublicense granted by Calixa hereunder
shall be fully consistent with and subject to the terms and conditions of this
Agreement; and (ii) Calixa shall remain responsible to Astellas for performance
of all obligations of Calixa under this Agreement, even if Calixa has
sublicensed some rights to sublicensees, provided, however, that notwithstanding
the foregoing, if Calixa []* which has been []* intends to []*, Calixa or such
[]* shall []*.  Nothing contained herein shall prevent Calixa or such []* from
engaging in discussions []* in accordance with this Agreement.

 

2.3 If Astellas is interested in []*, it shall so notify Calixa within sixty
(60) days of receiving such offer together with the []* and the necessary []*
from Calixa pursuant to Section 2.2 above.  Upon such notice provided by
Astellas and through the expiration of ninety (90) day period from Calixa’s
receipt of such notice provided by Astellas (or such longer period of time as
may be mutually agreed by the Parties) (such period, the “[]* Negotiation
Period”), the Parties shall negotiate in good faith the terms with regard to
such []*.  During such []* Negotiation Period, Astellas shall have the []* right
to negotiate with Calixa with regard to such []* and Calixa and its []* which
has been []* shall not []* on such []*.

 

2.4 If (i) Astellas notifies Calixa within the sixty (60) day period that it is
not interested in such []*, (ii) Astellas fails to notify Calixa that Astellas
is

 

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*Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

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interested in such []* within such sixty (60) day period, or (iii) the Parties
fail to enter into an agreement within the applicable []* Negotiation Period
despite the good faith negotiations between the Parties, then Calixa and its []*
which has been []* shall have the right to []*, provided however, in the case of
(iii) above, Calixa and such []* shall not []*.

 

2.5 If the circumstance described in Section 2.4 (iii) above exists, and in such
circumstance the []*, and Astellas shall have a period of forty (40) days from
the receipt of such notification to []*.  If Astellas informs Calixa of such []*
within such forty (40) day period, Calixa and Astellas shall be obligated to
[]*.  If Astellas []* such terms or fails to inform Calixa of such []* within
such forty (40) day period, then Calixa or such []* will be []*.  However, if
the []* between Calixa or such []* and []* (after the above procedure), and such
terms []* in the above procedure, then the above procedure regarding []* shall
be followed, before Calixa or such []*.”

 

2.6 Upon termination of this Agreement for any reason, each sublicense granted
by Calixa in accordance with this Article 2 shall survive with respect to the
rights granted by Astellas to Calixa hereunder and shall be automatically
assigned from Calixa to Astellas, so long as the sublicensee is then in
compliance with its sublicense agreement; provided, however, that Astellas’
obligations to any such sublicensee shall be no greater than Astellas’
obligations to Calixa hereunder.

 

5.                          Section 3.2 of the Agreement shall be deleted in its
entirety.

 

6.                          Section 4.5 of the Agreement shall be deleted in its
entirety and replaced by the following:

 

4.5 Immediately after (i) filing an NDA or (ii) obtaining a Regulatory Approval
in any country in the Territory and the New Territory, Calixa shall notify
Astellas of such event in writing.

 

7.                          Section 5.2 of the Agreement shall be deleted in its
entirety.

 

8.                          Sections 12.1 and 12.2 of the Agreement shall be
deleted in its entirety and replaced by the following:

 

12.1Calixa shall indemnify, defend and hold Astellas and its Affiliates, and
their respective directors, officers and employees, and the successors and
assigns of any of the foregoing, harmless from and against any and all
liabilities, damages, losses, costs and expenses, including without limitation
reasonable attorneys’ fees and other expenses of litigation resulting from any
Third Party claim, action, suit or proceeding (any of the foregoing, a “Claim”)
against any such indemnified party to the extent such Claim is based on or
results from:  (a) the exercise or practice by Calixa of the rights and licenses
granted to Calixa under this Agreement, (b) the manufacture, use or sale of any
Product or Compound used for development activities and/or distributed by or on

 

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*Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

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behalf of Calixa and/or its sublicensees, (c) Calixa’s breach of any warranties,
representations, or other obligations under this Agreement, or (d) any
negligence or willful misconduct of Calixa and/or its sublicensees, but
excluding from the foregoing obligations any Claims to the extent such Claims
are based on or result from:  (i) Astellas’s breach of any warranties,
representations, or other obligations under this Agreement or (ii) any
negligence or willful misconduct of Astellas or its Affiliate or Third Party
business partner.

 

12.2 Astellas shall indemnify, defend and hold Calixa and its Affiliates, and
their respective directors, officers and employees, and the successor and
assigns of any of the foregoing harmless from and against any and all Claims
against any such indemnified party to the extent such Claim is based on or
results from: (a) Astellas’s breach of any warranties, representations, or other
obligations under this Agreement, or (b) any negligence or willful misconduct of
Astellas or its Affiliate, or (c) the manufacture by or on behalf of Astellas
and/or its Affiliate or Third Party business partners, except to the extent that
such Claim is caused by (i) Calixa’s breach of any warranties, representations,
or other obligations under this Agreement, or (ii) any negligence or willful
misconduct of Calixa or its sublicensees.”

 

9.                          Exhibit A of the Agreement shall be deleted in its
entirety and replaced by Exhibit A attached to this Amendment.

 

10.                   Except as amended herein, all other terms and conditions
of the Agreement shall remain in full force and effect.

 

11.                   This Amendment shall be governed by and construed in
accordance with the laws of the State of New York, with the exception of its
conflict of laws rules.

 

[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK.]

 

 

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*Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

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IN WITNESS WHEREOF, the Parties have caused this Amendment to be executed by
their respective authorized representatives.

 

Astellas Pharma Inc.

 

 

/s/ Kenji Yasukawa

 

Name: Kenji Yasukawa

 

Title: Senior Vice President & Chief Strategy Officer

 

 

 

Calixa Therapeutics, Inc.

 

 

/s/ Michael W. Bonney

 

Name: Michael W. Bonney

 

Title: President

 

 

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*Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

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Exhibit A

 

Country

 

Appln.No.

 

Appln.Date

 

Pat.No.

 

Expiry Date

Argentina

 

P030103985

 

2003-10-30

 

has not been issued

 

2023-10-30

Brazil

 

PI0315188-3

 

2003-10-27

 

has not been issued

 

2023-10-27

Canada

 

2504730

 

2003-10-27

 

2504730

 

2023-10-27

China

 

200380102642.2

 

2003-10-27

 

ZL200380102642.2

 

2023-10-27

EPO

 

03758919.9

 

2003-10-27

 

EP 1 556 389 B1

 

2023-10-27

Austria

 

03758919.9

 

2003-10-27

 

ATE368042

 

2023-10-27

Belgium

 

03758919.9

 

2003-10-27

 

1556389

 

2023-10-27

Switzerland

 

03758919.9

 

2003-10-27

 

1556389

 

2023-10-27

Germany

 

03758919.9

 

2003-10-27

 

DE60315178.7

 

2023-10-27

Denmark

 

03758919.9

 

2003-10-27

 

1556389

 

2023-10-27

Spain

 

03758919.9

 

2003-10-27

 

ES2290498

 

2023-10-27

Finland

 

03758919.9

 

2003-10-27

 

1556389

 

2023-10-27

France

 

03758919.9

 

2003-10-27

 

1556389

 

2023-10-27

UK

 

03758919.9

 

2003-10-27

 

1556389

 

2023-10-27

Greece

 

03758919.9

 

2003-10-27

 

3063495

 

2023-10-28

Hungary

 

03758919.9

 

2003-10-27

 

E002339

 

2023-10-27

Ireland

 

03758919.9

 

2003-10-27

 

1556389

 

2023-10-27

Italy

 

03758919.9

 

2003-10-27

 

IT32358 BE/2007

 

2023-10-27

Luxembourg

 

03758919.9

 

2003-10-27

 

1556389

 

2023-10-27

Netherland

 

03758919.9

 

2003-10-27

 

1556389

 

2023-10-27

Portuguese

 

03758919.9

 

2003-10-27

 

1556389

 

2023-10-27

Sweden

 

03758919.9

 

2003-10-27

 

1556389

 

2023-10-27

Turkey

 

03758919.9

 

2003-10-27

 

TR200707206T4

 

2023-10-27

Hong Kong

 

06106532.6

 

2006-06-07

 

1086566

 

2023-10-27

India

 

936/KOLNP/2005

 

2003-10-27

 

212088

 

2023-10-27

S.Korea

 

10-2005-7007538

 

2003-10-27

 

10-1023035

 

2023-10-27

Japan

 

2005-501847

 

2003-10-27

 

4448821

 

2023-10-27

Philippines

 

1-2005-500802

 

2003-10-27

 

1-2005-500802

 

2023-10-27

Singapore

 

200502578-8

 

2003-10-27

 

112228

 

2023-10-27

Taiwan

 

092129984

 

2003-10-29

 

I319403

 

2023-10-28

USA

 

10/695895

 

2003-10-30

 

7129232

 

2024-10-20

S.Africa

 

2005/04181

 

2003-10-27

 

2005/04181

 

2023-10-27

 

Note : Expiry Date may be extended in some countries.

 

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*Confidential Treatment Requested.  Omitted portions filed with the Commission.

 

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