Exhibit 10.33


 


CONFIDENTIAL TREATMENT


 


LICENSE AGREEMENT


 


This
License Agreement (“Agreement”) made and entered into as of November 1st,
2007 (“Effective Date”) by and between Astellas Pharma Inc. having its
principal office at 3-11, Nihonbashi-Honcho 2-chome, Chuo-ku, Tokyo 103-8411,
Japan (“Astellas”) and Calixa Therapeutics, Inc. having its principal
office at 12481 High Bluff Drive, San Diego, CA 92130 (“Calixa”).


 


WITNESSETH:


 


WHEREAS,
Astellas has invented and developed a certain new antibiotic agent currently
identified as FR264205;


 


WHEREAS,
Astellas and Domain Associates L.L.C. (“Domain”), having its principal office
at 12481 High Bluff Drive, San Diego, 92130 USA, have entered into the
Confidentiality Agreement as of May 25, 2007 (“CDA”), and have been in
discussions in order to evaluate a potential business relationship or
collaboration relating to such antibiotic agent;


 


WHEREAS,
Calixa is incorporated as of July 11, 2007 and Domain is a shareholder of
Calixa; and


 


WHEREAS,
Astellas wishes to grant to Calixa, and Calixa wishes to obtain, a license
under the Patents (hereinafter defined) and the Know-How (hereinafter defined)
of Astellas to develop, manufacture, have manufactured, use, import, market,
promote, sell, offer to sell and distribute the Products in the Territory,
subject to the terms and conditions set forth in this Agreement;


 


NOW,
THEREFORE, in consideration of the mutual covenants and promises contained
herein, the Parties agree as follows:


 


1.                          DEFINITIONS


 


The
following capitalized terms as used herein shall have the meanings set forth in
this Article, and unless otherwise expressly set forth, the singular shall
include the plural and vice versa:


 


1.1                     “Affiliate” shall mean, with
respect to a Party, any corporation or other business entity that, directly or
indirectly, owns or controls, is owned or controlled by or is under common
ownership or controls with such Party. For purposes of this definition, an
entity shall be deemed to control another entity if it owns (directly or
indirectly) more


 






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


 

















 


than fifty percent (50%) of the outstanding
voting stock of such other entity, or otherwise has the actual ability to direct
and manage the business and management of such other entity (by contract or
otherwise).


 


1.2                     “Annual Net Sales” shall
mean the Net Sales accrued during a particular twelve-month period commencing
on the applicable January 1 in all countries within the Territory.


 


1.3                     “Calixa Trademark” shall
mean any specific trademark(s) owned by Calixa (or its Affiliate or
sublicensee) and used in association with marketing the Product in a country or
jurisdiction in the Territory.


 


1.4                     “Compound” shall mean the
pharmaceutical compound known as FR264205 having the chemical name of:


 


[]*.


 


1.5                     “Generic Competition” shall
mean that one or more []* Third Parties is selling, []*, a generic version of a
Product being sold by Calixa or any of its sublicensees in a particular country
in the Territory, which generic version contains the Compound.


 


1.6                     “IND” shall mean an
investigational new drug application for the FDA in the U.S. as defined in 21
C.F.R. 312 et seq., or any application equivalent thereto in another country or
jurisdiction within the Territory.


 


1.7                     “Know-How” shall mean any
and all information, processes, techniques, data, know-how and trade secrets
with respect to the Compound and/or the Product, including without limitation
toxicological, pharmacological, clinical and chemical data, specifications,
medical uses, adverse reactions, manufacture and quality control methods of the
Compound and/or the Product, existing as of the Effective Date or developed or
acquired during the term of this Agreement.


 


1.8                     “NDA” shall mean an
application seeking Regulatory Approval of any Product in the U.S. as defined
in 21 C.F.R. 314 et seq., or any application equivalent thereto in another
country or jurisdiction within the Territory.


 


1.9                     “Net Sales” shall mean the
actual proceeds of sales of the Product sold by Calixa and/or its sublicensees
to Third Parties (which shall not include Calixa’s []*), less (i) []*.


 


1.10               “Party” shall mean Astellas or Calixa.
Astellas and Calixa shall be collectively referred to as the “Parties”.


 






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


 


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1.11     “Patents”
shall mean the Product Patents and the Related Patents, as defined below:


 


The term “Related Patents” shall mean all patents
and patent applications (including patents issued thereon) in the Territory
that are owned or controlled by Astellas or its Affiliate on the Effective Date
and at any time during the term of the Agreement and claim or cover the Compound,
the Product, or the manufacture or use of the Compound or Product (or any part
thereof), other than the Product Patents.


 


The term “Product Patents” shall mean all patents
and patent applications (and patents issuing thereon) listed in Exhibit A
attached hereto as well as any continuations, continuations-in-part,
substitutes, divisions, reissues, revisions, reexaminations or extensions
thereof, and any foreign equivalents in the Territory of any of the foregoing,
and any other patent and patent applications which the Parties subsequently
agree to include in Exhibit A.


 


1.12               “Product” shall mean any pharmaceutical
preparation containing Compound as an active pharmaceutical ingredient, []* for
administration to humans.


 


1.13     “Regulatory
Approval” shall mean any and all approvals, licenses, registrations, or
authorizations of any Regulatory Authority as required or needed for
manufacture, marketing, sale, distribution and import of the Product in any
country within the Territory, and including solely for countries outside the
United States any pricing approvals needed to sell or obtain reimbursement for
sales of the particular Product in such country.


 


1.14               “Regulatory Authority” shall mean any
federal, national, multinational, state, provincial or local regulatory agency,
department, bureau, commission, council, court, tribunal, arbitrator, official
or other instrumentality of a governmental entity in any country within the
Territory.


 


1.15     “Territory”
shall mean worldwide excluding Japan, Taiwan, South Korea, China, Thailand,
Indonesia, the Philippines, Australia, New Zealand, India, Saudi Arabia,
Kuwait, Oman, Qatar, United Arab Emirates, Bahrain and Yemen.


 


1.16               “Third Party” shall mean a person or entity
other than a Party or an Affiliate of a Party.


 


1.17               “Valid Claim” shall mean a claim in any
issued and unexpired patent within the Patents, which (a) has not been
disclaimed, revoked or held invalid, unpatentable or unenforceable by a court
or other governmental agency of competent jurisdiction from which no appeal can
be further taken, and (b) has not been disclaimed, revoked, or held 


 






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


 


3

















 


or
admitted to be invalid, unpatentable or unenforceable through abandonment,
re-examination or disclaimer, opposition procedure, nullity suit or otherwise.


 


1.18     “[]*”
shall mean []*, a Japanese company, having its principal office at []*.


 


2.                          GRANT
OF LICENSE


 


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 Section 2.2),
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. Astellas hereby
grants to Calixa the []* license, with the full rights to grant sublicenses to
its Affiliates and to Third Parties through multiple tiers (subject to Section 2.2),
under the Related Patents to develop, manufacture, have manufactured, use,
import, market, promote, sell, offer to sell and distribute the Products in the
Territory, provided that such []* license shall be effective as far as Astellas
has the ability to grant such license. Astellas also hereby grants to Calixa
the []* license, with the right to sublicense under the Know-How and any
applicable patent rights of Astellas and its Affiliates to manufacture and have
manufactured the Compound and the Product in any country outside the Territory
solely for use and sale in the Territory.


 


2.2                     If Calixa intends to grant a
sublicense to its Affiliate or any Third Party, it shall []* 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 shall be []* for any reason
whatsoever; 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.


 


3.                          INFORMATION
EXCHANGE


 


3.1                     Promptly after the execution
of this Agreement, Astellas agrees to and shall provide to Calixa any and all
the Know-How then in the possession of Astellas or its Affiliate that is []*
for Calixa to exercise its rights and/or fulfill the purposes of this
Agreement, if not in English, together with the English summary thereof. Any
Know-How and 


 






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


 


4

















 


materials
disclosed by Astellas to Domain under the CDA and further disclosed by Domain
to Calixa subject to Astellas’ prior approval provided to Domain, if any, shall
be deemed to have been disclosed hereunder. Thereafter during the term of the
Agreement, Astellas shall promptly provide to Calixa any additional Know-How
that is developed, identified or acquired by Astellas or its Affiliates and is
[]* for Calixa to exercise its rights and/or fulfill the purposes of this
Agreement, if not in English, together with the English summary thereof.


 


Astellas shall make reasonably available to Calixa,
during Astellas’ business hours and for reasonable amounts of time, such of
Astellas’ employees as are appropriate (including key research, manufacturing
and/or development personnel) for purposes of consulting with Calixa regarding
the development, testing and manufacturing of Compound or Products, procuring
of Regulatory Approval of Products, and to enable Calixa to understand and use
the Know-How disclosed by Astellas and assure disclosure of such Know-How
pursuant to first paragraph of this Section 3.1. Calixa shall reimburse
Astellas for any out-of-pocket costs (if any) of providing any such consulting,
but its internal costs shall be borne by Astellas.


 


3.2                     Calixa shall disclose to
Astellas from time to time during the term of this Agreement any and all
Know-How which Calixa has heretofore developed or acquired or which Calixa
and/or its sublicensees may hereafter develop or acquire that is []* for
Astellas to exercise its rights or fulfill the purposes of this Agreement
(including Astellas confirming that Calixa is complying with its obligations
under the applicable terms of this Agreement). The following information and
documents, among others, shall be included in such Know-How to be disclosed by
Calixa to Astellas:


 


(i)                   the reports which shall be
submitted by Calixa pursuant to Section 4.4;


 


(ii)                any information on adverse
reactions or animal safety findings which shall be reported to Astellas by
Calixa pursuant to Section 4.8;


 


(ii)                Upon filing of the IND and
the NDA in any country within the Territory, a copy of the documents so filed;


 


(iv)            After filing of the IND and
the NDA in any country within the Territory, a copy of the supplemental
documents submitted after the filing of such IND and/or such NDA;


 


(v)               Upon obtaining the
Regulatory Approval in any country within the Territory, a copy of such
Regulatory Approval; and


 






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


 


5

















 


(vi)            Upon request by Astellas,
any other Know-How of Calixa and/or its sublicensees that is []* for Astellas
to exercise its rights or fulfill the purposes of this Agreement.


 


Calixa
shall provide Astellas with such Know-How developed or acquired by Calixa
and/or its sublicensees hereunder, if not in English, together with the English
summary thereof.


 


Astellas
shall have a []* right and license to use all Know-How (including any patent
claim obtained by Calixa that claims any such Know-How) developed or acquired
by Calixa and/or its sublicensees that is []* for Astellas to exercise its
rights or fulfill the purposes of this Agreement, solely for the development,
manufacture, having manufactured, use, import, marketing, promotion, sales,
offer for sale and distribution of the Product outside the Territory as well as
for manufacture or having manufactured the Compound and/or the Product in the
Territory solely for use and sale outside the Territory, and to disclose and
sublicense the same to its Affiliates and its Third Party business partner(s) for
the purpose mentioned above. In addition, Astellas shall have the right, []*,
to refer to, or to make use of, the Regulatory Approval filed and/or obtained
by Calixa or its sublicensees solely as needed for commercialization of the
Product by Astellas, its Affiliates and/or its Third Party business partners
outside the Territory.


 


Calixa
hereby grants Astellas the right of negotiation to []*. If Astellas requests
[]*, the Parties shall negotiate in good faith and seek to reach agreement on
[]*, provided that []*. The foregoing shall not prevent Calixa from []*.


 


4.                          DEVELOPMENT


 


4.1                     In compliance with any and
all applicable laws and regulations, Calixa shall []* perform and complete all
pre-clinical and clinical studies and other development activities necessary to
obtain and maintain the Regulatory Approval in each country within the
Territory []*, at its sole expense and responsibilities. Calixa shall have the
sole right and authority to conduct and control all such research and
development activities as to the Compound or the Products throughout the
Territory.


 


4.2                     Within ninety (90) days
following the Effective Date, Calixa shall prepare and submit to Astellas for
its review and comment a summary overview plan []* of []* (“Development Plan”).
Astellas may give any comment on the Development Plan submitted to Astellas
pursuant to this Section 4.2 and Calixa shall []* such Astellas’ comments
[]* and consistent with Calixa’s other obligations and rights under this
Agreement. While Calixa shall []* Astellas’ []* comments, it is understood and
agreed 


 






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


 


6

















 


that
Calixa shall have the sole authority to prepare and control the Development
Plan, and to amend and modify the Development Plan []* over the course of the
Agreement. Calixa shall []* amendments or modifications to the Development
Plan. It is further agreed that such initial Development Plan will necessarily
be in summary form with respect to any development activities []*, and that the
[]* for any such development activities []* will necessarily be []*, given the
early stage of research of the Compound as of the Effective Date.


 


Calixa
shall []* carry out all of such development activities in compliance with the
Development Plan, as such plan may be amended and modified, at its sole expense
and responsibilities.


 


4.3                     Calixa shall []* file the
NDA and obtain the Regulatory Approval []* at its sole expense and
responsibilities in each country []* within the Territory. Calixa shall be
responsible for preparation and submission of the NDA in each such country. If
Calixa determines that it shall not seek Regulatory Approval of Products in a
particular country within the Territory, then []*. In such case, []* (and all
other rights of Calixa under the Agreement shall remain unaffected).


 


Calixa
shall be responsible for and manage, and shall have the sole rights and authority
for, all interactions and filings with each Regulatory Authority in the
Territory. At the request of Astellas, and to the extent reasonable and not
contrary to Calixa’s or its sublicensee’s regulatory strategy and relationships
with the applicable Regulatory Authority, Calixa shall []* arrange that
representatives of Astellas may participate in []* meetings with such
Regulatory Authority. In addition, Calixa shall inform Astellas of any []* with
such Regulatory Authority. In course of the foregoing processes, Calixa shall
[]* consider and accommodate the []* comments made by Astellas with respect
thereto. Calixa (or its sublicensee, as applicable) shall own all regulatory
filings made in the Territory with respect to the Compound or the Product,
including INDs, NDAs and foreign equivalents thereof.


 


4.4                     For the purpose of this Section 4.4,
within []* days after the end of each calendar year []*, Calixa shall submit to
Astellas the reports disclosing in reasonable detail the progress, results,
data and other important issues relating to Calixa’s or sublicensees’
development activities under this Article 4 with regard to the Compound
and the Products, in such form as separately agreed upon between Astellas and
Calixa.  Within []* days after the end of
each calendar


 






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


 


7

















 


quarter
except the last calendar quarter in a calendar year, Calixa shall submit to
Astellas the brief description of the progress of []* under this Article 4
with regard to the Compound and the Products.


 


4.5                     []* after obtaining a
Regulatory Approval in a country in the Territory, Calixa shall submit to
Astellas a copy of such Regulatory Approval.


 


4.6                     Calixa shall []* maintain
each Regulatory Approval obtained by Calixa in each country within the
Territory at its sole expense and responsibilities.


 


4.7                     Within forty (40) days after
the Effective Date of this Agreement (or such later date as mutually agreed by
the Parties), Astellas shall provide all remaining Compound and Product then in
the possession of Astellas or its Affiliate. All such materials shall meet the
specifications specified in the certificate of analysis provided by Astellas
together with the materials. With regard to any such Compound or Product to be
used by Calixa for clinical studies, Astellas shall also provide any and all
Good Manufacturing Practice documentation necessary or helpful to support an
IND submission.  Calixa shall use the
materials provided hereunder only for the purpose of development activities
under this Article 4. Except as set forth above, Astellas shall not be
obligated to manufacture or supply any additional materials of the Compound or
the Product.


 


4.8                     During the term of this Agreement,
both Parties shall report to each other any information on adverse reactions or
animal safety findings associated with the use of the Compound and/or the
Product in accordance with the procedure separately agreed upon between
Astellas and Calixa.


 


5.                          PROCUREMENT
OF COMPOUND AND PRODUCT


 


5.1                     Except for the materials
provided by Astellas pursuant to Section 4.7 above, Calixa shall, at its
sole expense and responsibilities, procure all its requirements of the Compound
and/or the Product. Calixa shall []* ensure that any such amounts obtained
shall be in compliance with (i) such specifications as established by
Calixa (or if applicable as contained in the applicable Regulatory Approval);
and (ii) any applicable laws and regulations (including, but not limited
to, the Good Manufacturing Practice).


 


5.2                     If requested by Astellas,
Calixa and Astellas shall negotiate and seek to enter into a supply agreement
on commercially reasonable terms, under which Calixa would, upon request by
Astellas, []* on commercially reasonable terms and conditions as agreed upon by
the Parties.


 






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


 


8

















 


6.                          SALES
AND PROMOTION


 


6.1                     Upon Calixa’s obtaining Regulatory
Approval in a country in the Territory, Calixa shall []* market, promote, sell,
offer to sell and distribute the Product in such country in the Territory under
such Regulatory Approval in compliance with the applicable laws, regulations
and rules. Calixa shall []* Astellas’ []* requests or comments with respect to
such marketing efforts, but Calixa shall have sole rights and authority to
determine and control the marketing strategy and plan to market the Product
throughout the Territory.


 


6.2                     Calixa shall []*, at its
sole expense and responsibilities and subject to its sole discretion to
determine the appropriate marketing plans and strategies, to import, market,
promote, sell, offer to sell and distribute the Product in the Territory with
the general goal of maximizing the benefit []* from such sales of the Products
in the Territory.


 


6.3                     On a country-by-country
basis, Calixa shall launch the Product in the applicable country []* after
obtaining the Regulatory Approval in such country, but no later than []* after
such approval is obtained unless such launch is not []* by such date due to
factors outside of Calixa’s control. Calixa shall promptly notify Astellas of
the date of the launch of the Product in each country within the Territory. If
Calixa determines that it cannot launch the Product in a particular country
within the Territory within []* after Regulatory Approval is obtained in that
country, then Calixa shall give Astellas written notice of such determination,
and the reasons (if any) that it is not []* to launch the Product by such date
due to []*. In such case, if Calixa []* (and all other rights of Calixa under
the Agreement shall remain unaffected).


 


6.4                     Calixa shall promptly
provide to Astellas, solely for reference of Astellas, copies of all packages
and package inserts to be used by Calixa and its sublicensees for the Product
in each country within the Territory each time they are first prepared or
materially changed by Calixa and/or its sublicensees.


 


Upon
the reasonable request of Astellas, Calixa shall provide Astellas, solely for
reference of Astellas, with copies of any promotional materials for the
Product.


 


6.5                     Within []* days after the
close of each month, Calixa shall use reasonable efforts to provide Astellas
with a monthly sales report for the Product for such month, which shall show
the relevant []* by Calixa (to the level of accuracy that Calixa reasonably can
determine in such period) indicating the []*, together with its comments
thereon.  Calixa shall use reasonable
efforts to include in such monthly report the []*, but it is understood that
Calixa may not be able to obtain such data.


 


6.6                     In the Territory, Calixa
shall []*. For clarity, it is understood and agreed that for []*.


 






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


 


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7.                          RIGHT
OF FIRST REFUSAL FOR []*


 


7.1                     If Calixa or its sublicensee
intends to enter into a []* (each such opportunity, a “Business Opportunity”),
[]*.


 


7.2                     If Astellas is interested in
such Business Opportunity, it shall so notify Calixa within []* days of
receiving such offer together with the material terms and conditions of such
Business Opportunity and the necessary Know-How from Calixa pursuant to Section 7.1
above.  Upon such notice provided by
Astellas and through the expiration of []* day period from Calixa’s receipt of
such notice provided by Astellas (or such longer period of time as may be
mutually agreed to by the Parties) (such period, the “Negotiation Period”), the
Parties shall negotiate in good faith the terms under which they would
collaborate on such Business Opportunity. During such Negotiation Period, []*.


 


7.3                     If either (i) Astellas
fails to notify Calixa that Astellas is interested in such Business Opportunity
within such []* day period, or (ii) the Parties fail to enter into an
agreement within such Negotiation Period despite the good faith negotiations
between the Parties, then []*, provided however, in the case of (ii) above,
[]*.


 


7.4                     []*.


 


8.                            MILESTONE
AND ROYALTY PAYMENT


 


8.1                     In consideration of the
license granted by Astellas to Calixa hereunder, Calixa shall make the
following one time, non-refundable and non-creditable milestone payments to
Astellas upon first achievement of the applicable milestone event, as follows:


 


	
   

  	
   

  	
  Milestone Event

  	
   

  	
  Milestone Payment

  	
   

  
	
  (i)

  	
   

  	
  Upon
  entering into this Agreement.

  	
   

  	
  $

  	
  1,500,000

  	
   

  
	
  (ii)

  	
   

  	
  Upon
  commencing the first phase II clinical study for []* the Product.

  	
   

  	
  $

  	
  1,500,000

  	
   

  
	
  (iii)

  	
   

  	
  Upon
  commencing the first phase III clinical study for []* the Product.

  	
   

  	
  $

  	
  []

  	
  *

  
	
  (iv)

  	
   

  	
  Upon
  commencing a phase III clinical study []* different from that triggering
  milestone 8.1 (iii).

  	
   

  	
  $

  	
  []

  	
  *

  



 






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


 


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  (v)

  	
   

  	
  Upon
  submitting the first NDA for the []* for []* the Product.

  	
   

  	
  $

  	
  []

  	
  *

  
	
  (vi)

  	
   

  	
  Upon
  submitting the first NDA for the []* for []* different from that triggering
  milestone  8.1 (v).

  	
   

  	
  $

  	
  []

  	
  *

  
	
  (vii)

  	
   

  	
  Upon
  obtaining the first Regulatory Approval in the []* for []* of the Product.

  	
   

  	
  $

  	
  []

  	
  *

  
	
  (viii)

  	
   

  	
  Upon
  obtaining the first Regulatory Approval in the []* for []* different from
  that triggering milestone 8.1 (vii).

  	
   

  	
  $

  	
  []

  	
  *

  
	
  (ix)

  	
   

  	
  Upon
  first achievement of Annual Net Sales of US$[]*.

  	
   

  	
  $

  	
  []

  	
  *

  
	
  (x)

  	
   

  	
  Upon
  first achievement of Annual Net Sales of US$[]*.

  	
   

  	
  $

  	
  []

  	
  *

  
	
  (xi)

  	
   

  	
  Upon
  first achievement of Annual Net Sales of US$[]*.

  	
   

  	
  $

  	
  []

  	
  *

  
	
   

  	
   

  	
  TOTAL

  	
   

  	
  $

  	
  47,000,000

  	
   

  



 


Calixa
shall be obligated to make each milestone payment mentioned above only once.


 


Calixa
shall []* and shall make payment of the milestone amounts specified above by
wire transfer to a bank account to be designated by Astellas within thirty (30)
days following the occurrence of each milestone event mentioned above.


 


8.2                     In further consideration of
the license granted by Astellas to Calixa hereunder, Calixa shall pay, []* of
the Products in the Territory, to Astellas a royalty as a percentage of Net
Sales made by Calixa or its sublicensees in the Territory, where the percentage
rate applicable to a particular sale shall depend on the aggregate amount of
Annual Net Sales in the given calendar year through to the time of sale, in
accordance with the following:


 


(i)                               []* of the
first []* US Dollars (US$ []*) of Annual Net Sales in the given calendar year;


 






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


 


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(ii)                            []* of the
amount of Annual Net Sales in excess of the first []* US Dollars (US$ []*) of
Annual Net Sales in such calendar year, and []* US Dollars (US$ []*) or less of
Annual Net Sales in such calendar year;


(iii)                         []* of the
amount of Annual Net Sales in excess of the first []* US Dollars (US$ []*) of
Annual Net Sales, and []* US Dollars (US$ []*) or less of Annual Net Sales; and


(iv)                        []* of the
amount of Annual Net Sales in excess of the first []* US Dollars (US$ []*) of
Annual Net Sales.


 


The
above royalties shall be payable on the Net Sales of the Product in each
country within the Territory, on a country-by-country basis, until the later
of: []*, the Net Sales occurred in such country shall not be included in the
Annual Net Sales in determining the royalty rate of the Product under this Section 8.2.


 


Notwithstanding
the foregoing, if Calixa, in its good faith judgment, determines that it is []*
to obtain license rights in any country in the Territory from a Third Party (a “Third
Party License”) under patent rights owned or controlled by such Third Party
that []*, (“Third Party Patent Rights”), Calixa shall have the right to enter
into such Third Party License. []*. Calixa may reduce the royalties owed to
Astellas under the above provisions of this Section 8.2 based on sales of
Product []* by a Third Party License by the following amounts, as applicable: (a) if
the particular Third Party Patent Rights that are the subject of the such Third
Party License []* of the Compound, an amount equal to []* of the amounts of
royalties Calixa pays to such Third Party based on such sales of Product under
such Third Party License during the applicable royalty period, but provided
however that such reduction shall not reduce such royalties owed to Astellas
based on such sales of the Product (in the applicable royalty period) by more
than []* of the amounts otherwise owed by Calixa as a result of application of
this subclause (a) of this provision; and (b) if the particular Third
Party Patent Rights that are the subject of such Third Party License []* of the
Compound, an amount equal to []* of the amounts of royalties Calixa pays to
such Third Party based on such sales of Product under such Third Party License
during the applicable royalty period, but provided however that such reduction
shall not reduce such royalties owed to Astellas based on such sales of the
Product (in the applicable royalty period) by more than []* of the amounts
otherwise owed by Calixa as a result of application of this subclause (b) of
this provision. In no event, the total amount of the reductions of the
royalties as a result of Third Party License under subclauses (a) and (b) of
this provision shall exceed the []* of the amounts of the royalties owed by
Calixa to Astellas based on the sales of the Product during the applicable
royalty period.


 






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8.3                     For a sale of Product in a
country within the Territory at a time when (a) there does not exist any
Valid Claim that claims or covers the Compound or the Product, []*, then the
royalty rate applicable to such sale shall be the following, as applicable: (i) []*
of the rate otherwise applicable to such sale based on the royalty rate
schedule in subsections (i), (ii), (iii) or (iv) of Section 8.2
above, if at the time of such sale there is []* in that country; and (ii) []*
of the rate otherwise applicable to such sale based on the royalty rate
schedule in subsections (i), (ii), (iii) or (iv) of Section 8.2
above if there is at the time of such sale []* in that country.


 


8.4                     Calixa shall deliver to
Astellas the royalty statements in such form as Astellas shall reasonably
request, which reports generally shall list: []*. Such reports shall be given
within []* days following the close of each calendar quarter (i.e. the
quarterly period ending on 31st March, 30th June, 30th September or 31st
December), and Calixa shall at the same time pay to Astellas, or to whomsoever
Astellas shall otherwise direct in writing from time to time, the amount of
such royalties shown to be due.


 


8.5                     All payments payable
hereunder by Calixa to Astellas shall be made in US Dollar to a bank account
designated by Astellas. Royalties earned shall be first determined in the
currency of the country in which they are earned and then converted to its
equivalent in US Dollar at the interbank rate quoted by the Wall Street Journal, on the last business day of the
calendar quarter in question.


 


8.6                     Any income or other tax
which Calixa is required to pay or withhold on behalf of Astellas with respect
to the payments pursuant to this Article 8 shall be deducted from the
amount of such payment due, provided, however, that in regard to any such
deduction, Calixa shall give Astellas such assistance as may reasonably be
necessary for Astellas to claim exemption therefrom and shall, upon request of
Astellas, give Astellas proper evidence from time to time as to the payment of
the tax.


 


8.7                     Late payments shall be
subject to an interest charge at an annualized interest rate equal to the
average (over one month) London Inter-Bank Offering Rate (LIBOR) []*, or
maximum rate permitted by law, whichever is lower.


 


8.8                     Calixa shall keep true and
accurate accounts of all royalties payable to Astellas under Article 8.
Such records shall be retained and made available for reasonable review by
Astellas or its Affiliates, unless Calixa has a reasonable basis for objecting
to review thereby, or by an independent, nationally-recognized public
accounting firm selected by Astellas, and to which Calixa has no reasonable
objection, for the purpose of verifying the accuracy of the calculations and
payments made or payable hereunder. Such review shall be conducted no more
frequently than []* per year and shall not cover any period 


 






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ending
more than []* years prior to the date of such examination. All such reviews
shall be scheduled during ordinary business hours and with reasonable notice to
Calixa, such reviewing firm shall sign a typical and reasonable confidentiality
agreement binding the firm to reasonable confidentiality provisions regarding
the information it reviews. Such firm shall not disclose any information of
Calixa gained in such review, except to confirm the accuracy of Calixa’s
royalty payments or, if applicable, to disclose the extent of any inaccuracy.


 


9.                          TRADEMARKS


 


9.1                     Calixa and its sublicensees
shall have the right to manufacture, import, use, promote, market, sell, offer
to sell and distribute the Products throughout the Territory under the Calixa
Trademark(s) or any other trademark (other than the trademarks owned by
Astellas ) as may be selected by Calixa or its sublicensees.


 


10.                   CONFIDENTIALITY


 


10.1               Except as specifically authorized by this
Agreement, during the term of this Agreement and for a period of five (5) years
thereafter, or fifteen (15) years from the Effective Date, whichever is longer,
each of Astellas and Calixa shall keep in strict confidence any and all
confidential information obtained from the other Party under this Agreement
(the “Confidential Information” of the disclosing Party), including without
limitation the Know-How obtained from the other Party pursuant to Section 3.1
or 3.2. Each Party shall not (i) use for any purpose other than as
provided for in this Agreement and (ii) disclose to any Third Party, any
Confidential Information of the other Party without first obtaining a written
consent of the disclosing Party, except for such Confidential Information of
the other Party that:


 


(i)                   is a part of the public
domain prior to the disclosure;


(ii)                becomes a part of the public
domain after disclosure without any breach by the receiving Party;


(iv)            is disclosed to the
receiving Party by a Third Party who has the right to make such disclosure; or


(v)               is independently developed
by the receiving Party without any reference to any of the disclosing Party’s
Confidential Information.


 


10.2     Calixa
agrees to make Confidential Information of Astellas available only to those of
its and its sublicensees’ directors, officers, employees, consultants and
advisors who need to have access thereto for the purposes mentioned in this
Agreement and who are bound by confidentiality and non-use obligations
consistent with those provided herein. Astellas agrees to make Confidential
Information of Calixa available only to those of its, 


 






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its
Affiliates’, []* and its Third Party business partner(s) (including its
potential Third Party business partner(s))’ directors, officers, employees,
consultants and advisors who need to have access thereto for the purposes
permitted in this Agreement and who are bound by confidentiality and non-use
obligations consistent with those provided herein.


 


10.3     Notwithstanding
anything herein to the contrary, a Party may, to the extent necessary for the
purposes permitted in this Agreement and/or for exercising its rights and/or
performing its obligations under the Agreement, disclose certain Confidential
Information of the other Party to: (i) governmental bodies, (ii) clinical
organizations, (iii) clinical investigators, (iv) the Contract
Research Organizations, and (v) other contractors as needed in assisting
in performing research or development activities with respect to Compound or
Product, as well as potential investors in Calixa provided
that such entities are bound by appropriate confidentiality and
non-use obligations.


 


10.4     Notwithstanding
anything herein to the contrary, a Party may disclose specific Confidential
Information of the other Party to the extent the disclosure is required by a
valid order of a court or other governmental body having jurisdiction; provided
that the disclosing Party shall provide the other Party with reasonable prior
notice of such requirement, so that the other Party can file a motion for a
protective order or otherwise seek whatever legal relief it deems desirable or
appropriate to protect its interest in such Confidential Information.


 


10.5     Astellas
and Calixa acknowledge that any breach or threatened breach of any term of this
Article 10 may cause immediate and irreparable harm to the disclosing
Party, which may not be adequately compensated by monetary damages. Astellas
and Calixa therefore agree that the disclosing Party shall have the right to
seek equitable relief in the form of injunctions, orders of specific
performance or other equitable relief as a remedy, in addition to any other
remedies that may be legally available.


 


11.                   INFRINGEMENT
AND OTHER PATENT MATTERS


 


11.1               Calixa shall promptly inform Astellas of all
actual or threatened infringements of any Patent made by any Third Party in the
Territory as soon as it becomes aware of the same. Calixa shall have the first
option and right (but not the obligation) to bring any suit and/or defend any
declaratory judgment of non-infringement action to enforce the Patent as it may
deem necessary or appropriate to terminate or prevent such infringement in the
Territory at its own expense. Calixa shall keep Astellas informed of the
progress and the results of such action, and shall, upon Astellas’ request,
provide Astellas with related information regarding such action, excluding
privileged 


 






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documents.
Astellas shall give all reasonable assistance except for financial assistance
to Calixa in any such action. Astellas may join such suit with counsel at its
expense and seek its own damages and other relief, provided
that Calixa shall in any event control the prosecution of the suit
or action. Calixa shall be entitled to keep and retain all amounts and
recoveries from such suit or action prosecuted by Calixa, excluding any amounts
of damages or relief directly awarded to Astellas in the event Astellas joined
such suit or action, which Astellas may retain. 
If Calixa does not institute any action for any of such infringement
against said Third Party within []* days after written notice thereof, and
Calixa does not provide to Astellas by such time a []*, then Astellas may
institute any action for any of such infringement against said Third Party at
its expense. In this event, Calixa shall give all reasonable assistance except
for financial assistance to Astellas, and Calixa may join such suit with its
own counsel at its own expense and seek its own damages and other relief.
Astellas shall be entitled to keep and retain all amounts and recoveries from
such suit or action prosecuted by Astellas, excluding any amounts of damages or
relief directly awarded to Calixa in the event Calixa joined such suit or
action, which Calixa may retain.


 


11.2               Calixa will own all right, title and interest
in and to all Know-How that are conceived, reduced to practice, made or
developed solely by or on behalf of Calixa (whether or not patentable), and all
intellectual property rights (including patent rights) appurtenant thereto,
subject only to the limited license rights under the Know-How of Calixa granted
to Astellas under Section 3.2 of this Agreement.


 


11.3               Astellas shall []* conduct in good faith the preparation,
filing, prosecution, issuance and maintenance (including, without limitation,
interference, opposition and similar Third Party proceedings before the
relevant patent office) of any and all patent applications or patents in the
Patents throughout the Territory (“Prosecution”), at its expense and through
patent counsel selected by Astellas. Astellas shall keep Calixa informed of all
such Prosecution efforts and the results thereof, and shall provide Calixa
reasonable opportunities to consult with Astellas regarding such Prosecution by
Astellas. Calixa shall cooperate with and assist Astellas reasonably in such
Prosecution of the Patents.


 


11.4               During the Term, Astellas shall provide or
have provided to Calixa copies of: (i) all material, substantive documents
relating to Patents received by Astellas from any patent office in the
Territory promptly after receipt from the patent office and (ii) all
documents to be filed by Astellas, in sufficient advance notice so as to give
Calixa []* days for review and comments or such lesser period as may be
required by the patent office, respectively, including without limitation
copies of each patent application, official action, response to official
action, declaration, information disclosure statement, 


 






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request
for terminal disclaimer, request for patent term extension, and request for
reexamination.  Calixa shall have the
right to comment on such documents, and Astellas shall reasonably consider in
good faith any reasonable comments timely received from Calixa. If requested by
Astellas in good faith, Calixa shall use good faith, diligent efforts to review
and respond to Astellas with any comments on any of the above documents []*.
Calixa shall have the right to request that Astellas file additional patent
applications within the Patents in particular countries within the Territory,
and Astellas shall []* accommodate such requests to the extent that such
request made by Calixa is reasonable and practicable.


 


11.5            Astellas shall not, without Calixa’s written
consent, abandon or cease Prosecution of any of the Patents in the United
States, Canada, United Kingdom, Germany, France, Italy or Spain (the “Major
Countries”). Astellas shall notify Calixa in the event it for any reason elects
to abandon, or shall otherwise not continue, the Prosecution of a particular
patent application or maintenance of an issued patent within the Patents in any
country in the Territory (other than in favor of a continuing application based
on such parent application).  Such
notification shall specify the application to be abandoned or patent that will
no longer be maintained by Astellas and shall be given within a reasonable
period (i.e., with sufficient time for Calixa to take action as may be
necessary or desired) prior to the date on which such patent application(s) or
patent(s) will lapse or go abandoned. Calixa shall then have the option,
exercisable upon written notification to Astellas, to assume full
responsibility, at its discretion and its cost and expense, for Prosecution of
the affected patent application(s) or maintenance of any of the affected
patent(s) in such country or countries in the Territory. If Calixa so
elects to conduct Prosecution of a particular Patent in any country outside a
Major Country as provided in the foregoing, Calixa may []*. If Calixa so elects
to conduct Prosecution of a particular Patent in a Major Country as provided in
the foregoing, Calixa may []*.


 


11.6               If Calixa desires that Astellas file any or
all applications and take actions necessary to obtain patent extension pursuant
to 35 U.S.C. § 156 or similar foreign statutes for the Patents in the
Territory, Calixa shall so notify Astellas promptly after obtaining Regulatory
Approval in the U.S. or other countries where Calixa desires to file such
patent extension. Astellas agrees to take all necessary actions, including
filing all needed applications, to obtain the requested patent extensions at
Astellas’ cost and expense. Calixa shall cooperate with and assist Astellas in
such intended patent extension of the Patents, including without limitation
providing all necessary documents to Astellas. 
To the extent permitted under applicable law, Calixa may take 


 






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all
steps and make all applicable filings and applications to obtain the requested
patent extensions if and to the extent that Astellas fails to do so in a timely
manner.


 


12.                   INDEMNIFICATION


 


12.1               Calixa 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 behalf of Calixa
and/or its sublicensees in the Territory or manufacture by or on behalf of
Calixa and/or its sublicensees outside the Territory, (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, use or sale of any Product or Compound used for development
activities and/or distributed by or on behalf of Astellas and/or its Affiliate
or Third Party business partners outside the Territory, or manufacture by or on
behalf of Astellas and/or its Affiliate or Third Party business partners inside
the Territory, 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.


 


12.3               In the event that either Party intends to
claim indemnification under this Article 12, it shall promptly notify the
other Party in writing of such alleged Claim. The indemnifying Party shall have
the right to control the defense thereof with counsel of its 


 






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choice;
provided, however, that any indemnified Party shall have the right to retain
its own counsel at its own expense. The indemnified Party shall cooperate with
the indemnifying Party and its legal representatives in the investigation of
any Claim covered by this Article 12. The indemnified Party shall not,
except at its own cost, voluntarily make any payment or incur any expense with
respect to any Claim or related suit without the prior written consent of the
indemnifying Party, which such Party shall not be required to give.


 


13.                   WARRANTIES
AND DISCLAIMER


 


13.1               Astellas hereby represents and warrants to
Calixa as of the Effective Date that:


 


(i)                         Astellas owns,
or Astellas []*, the entire right, title and interests in and to all the
Patents;


(ii)                      Astellas has
the exclusive right and full legal authority to grant to Calixa the exclusive
license throughout the Territory under all rights and interest in and to the
Patents ([]*) and under the Know-How to make, have made, use, import, offer for
sale and sell Products;


(iii)                   No Third Party, including
[]*, has any interest or rights in or under the Patents or Know-How to make,
have made, use, import, offer for sale and/or sell Products in any country or
jurisdiction in the Territory;


(iv)                  as far as Astellas is aware
after certain internal patent searches in the normal course of its business,
the manufacture, use and/or sale of the Compound and the Product does not
infringe any patent owned or controlled by a Third Party anywhere in the
Territory;


(v)                     Astellas is not aware of any
prior art or facts or circumstances that would cause any of the Patents to be
invalid, unenforceable or not patentable;


(vi)                  Astellas has no knowledge,
and is not aware of any facts or circumstances that would lead it to believe,
that any Third Party is infringing any of the Patents or misappropriating or
using any Know-How in derogation of the rights granted to Calixa in this
Agreement;


(vii)               Astellas is not aware of any
facts that indicate the existence of any material side effect, toxicity effect,
carcinogenicity effect, adverse effect or any instances of deleterious physical
effects or reactions resulting from, or alleged to result from, the Compound or
Product, which have not been previously disclosed to Calixa by Astellas in
writing;


(viii)            Astellas is not aware that
any of the written statements and other writings furnished by Astellas pursuant
to or in connection with this Agreement or the transactions contemplated hereby
are materially inaccurate or are untruthful, or 






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omit
to disclose material facts of which Astellas is aware, where the failure to
disclose such facts makes such written statements or other writings materially
misleading; and


(ix)                    Astellas has provided to
Calixa a true, correct and complete copy of the agreement between Astellas and
[]* pursuant to which []* has granted to Astellas the []*, and an English
translation of the section(s) setting forth such Astella’s exclusive
rights in the agreement.


 


13.2               Calixa hereby represents and warrants to
Astellas as of the Effective Date that:


 


(i)                         Calixa is not
aware that any of the written statements and other writings furnished by Calixa
pursuant to or in connection with this Agreement or the transactions
contemplated hereby are materially inaccurate or are untruthful, or omit to
disclose material facts of which Calixa is aware, where the failure to disclose
such facts makes such written statements or other writings materially
misleading; and


(ii)       Calixa has the ability
to perform its obligations under this Agreement.


 


13.3               Each Party hereby represents, warrants and
covenants to the other Party as of the Effective Date that:


 


(i)                         such Party is a
corporation or entity duly organized, validly existing and in good standing
under the laws of the jurisdiction of its incorporation and has full corporate
power and authority to execute and deliver this Agreement and to carry out the
provisions hereof;


(ii)                      such Party is
duly authorized, by all requisite corporate action, to execute and deliver this
Agreement and to carry out the provisions hereof, and the person executing this
Agreement on behalf of such Party is duly authorized to do so by all requisite
corporate action;


(iii)                no consent, approval, order
or authorization of, or registration, qualification, designation, declaration
or filing with, any federal, state or local governmental authority is required
on the part of such Party in connection with the valid execution, delivery and
performance of this Agreement, except where the failure to obtain any of the
foregoing would not have a material adverse impact on the ability of such Party
to meet its obligations hereunder;


(iv)                  this Agreement constitutes a
legal and valid obligation binding upon such Party and enforceable in
accordance with its terms; and


(v)                     the execution, delivery and
performance by it of this Agreement and its compliance with the terms and
provisions of this Agreement does not and will not conflict with or result in a
material breach of any of the terms or provisions of (i) any other
contractual or other obligations of such Party, (ii) the provisions of its
charter, operating documents or bylaws, or (iii) any order, writ,
injunction or decree of any court or governmental authority entered against it
or by which it or 


 






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any of its property is bound except where such breach or conflict would
not have a material adverse impact on the Party’s ability to meet its
obligations hereunder.


 


13.4               EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN
THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATIONS NOR EXTENDS ANY
WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING, WITHOUT
LIMITATION, ANY WARRANTY OF NON-INFRINGEMENT OF ANY THIRD PARTY INTELLECTUAL
PROPERTY RIGHTS OR OTHER RIGHTS, MERCHANTABILITY, FITNESS FOR A PARTICULAR
PURPOSE AND VALIDITY WITH RESPECT TO THE PATENTS LICENSED HEREUNDER, NOR DOES
ASTELLAS MAKE ANY WARRANTY AS TO THE RESULTS THAT MAY BE OBTAINED BY
CALIXA WITH RESPECT TO THE PATENTS LICENSED HEREUNDER.


 


14.                   DURATION


 


This
Agreement becomes effective from the Effective Date and shall, unless sooner
terminated pursuant to any other provision of this Agreement, be in effect, on
a country by country basis, as long as Calixa or its sublicensee continues
developing or selling the Product in such country within the Territory.


 


15.                   TERMINATION


 


15.1               Material failure by a Party to comply with
any of its respective material obligations or conditions contained in this
Agreement shall entitle the other Party to give to the Party in default notice
requiring it to cure such material default and specifying in detail the basis
for the allegation of default. If such material default is not cured within []*
days (or []* days with respect to material breach by Calixa of its payment
obligation under Article 8) after receipt of such notice, the notifying
Party shall be entitled (without prejudice to any of its other rights conferred
on it by this Agreement) to terminate this Agreement by giving written notice
of termination to take effect immediately, except as
otherwise provided in Section 15.3 below.


 


15.2     In the
event that one of the Parties goes into liquidation, or a receiver or a trustee
is appointed over all or substantially all of the property or estate of that
Party, or the Party makes an assignment for the benefit of creditors of all or
substantially all of its assets, and whether any of the aforesaid events be the
outcome of the voluntary act of that Party, or otherwise, the other Party shall
be entitled to terminate this Agreement forthwith by giving a written notice to
the first Party.


 






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15.3               If Calixa, or its sublicensees, has []* and
[]*, then thereafter, so long as Calixa, or its sublicensees, continues to []*
develop and/or commercialize Product in each country in the Territory in which
it is []*, then notwithstanding the provisions of Section 15.1 Astellas
shall not have the right to terminate the Agreement under Section 15.1
above unless the uncured material default by Calixa is of the following
obligations: []*; in any such case Astellas may exercise the termination rights
under Section 15.1 if such breach remains uncured; notwithstanding the
foregoing, []*.


 


15.4               In the event that: (a) there occurs
either (i) a substantial change in control of Calixa (meaning that the
shareholders of Calixa just prior to the transaction own less than 50% of the
voting stock of Calixa after the transaction) pursuant to a merger with or an
acquisition by a Third Party, or (ii) a sale by Calixa to a Third Party of
all or substantially all of the assets of Calixa; (b) such Third Party is,
at the time of the closing of the transaction under subsection (a) above,
[]*, then Astellas shall have the right to terminate this Agreement forthwith
by written notice, solely in such countries where such Third Party []*.


 


15.5               In the event Calixa contests or challenges in
a legal proceeding the validity of the Patent, []*.


 


15.6            Calixa shall have the right to terminate this
Agreement in its entirety without cause, or for any cause, on []* written
notice to Astellas, []*. In the alternative, Calixa shall have the right to
terminate the Agreement solely as to particular countries, on []* prior written
notice to Astellas, in which case such country or countries covered by such
notice shall be removed from the Territory, and all rights granted by Astellas
under this Agreement with respect to such countries shall automatically
terminate and revert to Astellas upon such termination, but the Agreement shall
remain in full force and effect, and all of Calixa’s rights and obligations
shall remain, as to all other countries in the Territory.


 


16.                   RIGHTS
AND OBLIGATIONS UPON EXPIRATION AND TERMINATION


 


16.1               The termination or expiration of this
Agreement for any reason shall be without prejudice to:


 


(i)                         Calixa’s obligations to
disclose to Astellas any and all Know-How which Calixa and/or its sublicensees
developed or acquired (with the right to disclose) prior to the date of such
termination or expiration and has not yet disclosed to Astellas pursuant to Section 3.2;


(ii)                      Astellas’s right to receive
all payments accrued hereunder prior to the date of such


 






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termination or expiration;


(iii)                   Calixa’s obligation provided for in Sections
8.6, 8.7 and 8.8;


(iv)                  Astellas’s right provided in Section 8.8;


(v)                     Both Party’s confidentiality
obligation provided for in Article 10;


(vi)                  Calixa’s indemnification obligation provided
for in Section 12.1;


(vii)               Astellas’s
indemnification obligation provided for in Section 12.2;


(viii)            Both Party’s
agreements set forth in Article 17; and


(ix)                    Any other remedies which
either Party may then or thereafter have hereunder or otherwise.


 


16.2               In the event of termination
or expiration of this Agreement in its entirety or with respect to any
particular country pursuant to Section 4.3, 6.3 or 15.6, except for
termination of this Agreement by Calixa pursuant to Section 15.1 or 15.2,
on and after the date of such termination, Astellas shall have a []* right and
license to use all Know-How (including any patent obtained thereon) developed
or acquired by Calixa and/or its sublicensees, for the purpose of development,
manufacture, import, marketing, promotion, sales, offer for sales and
distribution of the Compound, the Product []* (a) in any country of the
world, in the case of termination of the entire Agreement, or (b) in the
particular country of termination, in the case of termination of the Agreement
only as to such country (as applicable), and to disclose and sublicense the
same to its Affiliates and its Third Party business partner(s) for the
purpose mentioned above in this Section.


 


In
the event of termination or expiration of this Agreement in its entirety or
with respect to any particular country pursuant to Section 4.3, 6.3 or
15.6 except for termination of this Agreement by Calixa pursuant to Section 15.1
or 15.2, Astellas shall also have the right, []*, to refer to, or make use of,
the Regulatory Approval filed and/or obtained by Calixa or its sublicensees for
commercialization of the Product by itself, its Affiliates and/or its Third
Party business partners (a) in any country of the world, in the case of
termination of the entire Agreement, or (b) in the particular country of
termination, in the case of termination of the Agreement only as to such
country (as applicable).


 


16.3               Upon termination or expiration of this
Agreement for any reason whatsoever (other than termination by Calixa under Section 15.1
and 15.2), Calixa shall (except as needed for the limited rights set forth in Section 16.4)
cease using or practicing the Patents and the Astellas Know-How disclosed by
Astellas and return to Astellas or destroy, as requested by Astellas, all
Confidential Information received from Astellas, including any copy,
reproduction, summary and other physical embodiments thereof. In case of
destruction of the Confidential Information, Calixa shall submit to Astellas
the document which certifies said destruction without delay.


 






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


 


23

















 


16.4               Upon termination of this Agreement by Calixa
under Section 15.1 or 15.2, Astellas shall cease using or practicing the
Know-How developed and acquired by Calixa or its sublicensees and return to
Calixa or destroy, as requested by Calixa, all Confidential Information
received from Calixa, including any copy, reproduction, summary and other
physical embodiments thereof, provided that above provision shall not prevent
Astellas to continue granting a non-exclusive license to use the Know-How
developed or acquired by Calixa and/or its sublicensees granted under Section 3.2
to its Third Party business partner(s) which license was granted to said
Third Party business partners prior to termination of this Agreement by Calixa
under Section 15.1 or 15.2. In case of destruction of the Confidential
Information, Astellas shall submit to Calixa the document which certifies said
destruction without delay. Calixa shall have the right, in its sole discretion,
to continue the licenses granted to it under Section 2.1, []*.


 


16.5               Subject to Calixa’s rights under Section 16.4,
upon termination or expiration of this Agreement for any reason whatsoever,
Astellas shall grant Calixa (i) the right to sell in the Territory the
Product then held by Calixa as a stock and (ii) the right to convert the
remaining Compound into the Product and to sell the same in the Territory, for
a period of []* or such a period to be agreed upon between the Parties; it
being confirmed that, (i) in no event, Astellas is obligated to take over
or purchase any stock of the Product or the Compound held by Calixa or its
sublicensees and (ii) with respect to the Product sold by Calixa and/or
its sublicensees pursuant to this Section 16.4, []*.


 


17.                   GENERAL


 


17.1               Force Majeure: No failure, delay or omission
by a Party in the performance of any of its obligations under this Agreement
shall be deemed a breach of this Agreement nor create any liability if the same
shall arise from any cause or causes beyond the control of such Party,
including an act of God, acts or omissions of any government or any rules,
regulations or orders of any Regulatory Authority or any officer, department,
agency or instrument hereto; fire, storm, flood, earthquake, accident, acts of
the public enemy, war, terrorism, rebellion, insurrection, riot, invasion,
strikes, lockouts, epidemic or petroleum crisis, so long as such Party
continues to use good faith, diligent efforts to avoid the effects of such
cause or causes and perform its obligations.


 


17.2               Notice: Any notice required or permitted to
be given under this Agreement shall be deemed to have been duly given only if
delivered personally, by facsimile with confirmation of receipt, by mail (first
class, postage prepaid), or by express delivery using a globally recognized
courier to the Party at its address stated below, or at such other address as
may hereafter be furnished in writing to the notifying Party:


 






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


 


24

















 


If to Astellas:


Astellas Pharma Inc.


3-11, Nihonbashi-Honcho 2-chome, Chuo-ku, Tokyo
103-8411, Japan


Attention: Vice President, Business Development


Facsimile: +81-3-3244-3245


 


With a copy to: Attention: Vice President, Legal


Facsimile: +81-3-3244-5811


 


If to Calixa: Calixa Therapeutics, Inc.


12481 High Bluff Drive, Suite 150, San Diego,
CA 92130 USA


Attention: Chief Executive Officer


Facsimile: 858.480.2401


 


With a copy to:


Attention: Chief Financial Officer


Facsimile: 858.480.2401


 


Any such notice shall be deemed to have been
received upon receipt of the addressee.


 


17.3               Waiver: The failure on the part of
Astellas or Calixa to exercise or enforce any rights conferred upon it hereunder
shall not be deemed to be a waiver of any such rights nor operate to bar the
exercise or enforcement thereof at any time or times thereafter.


 


17.4               Severability: Nothing contained in this
Agreement shall be construed as requiring the commission of any act contrary to
law. Should any Section of this Agreement be or become legally
ineffective, the validity of the Agreement as a whole shall not be affected.
The parties hereto rather undertake to replace the ineffective Sections by
legally effective ones which come as close as possible to the sense of such
ineffective Sections and the purpose of this Agreement.


 


17.5               Entire Agreement: This
Agreement contains the entire understanding between the Parties with respect to
the subject matter hereof, and it expressly supersedes any and all prior
understandings or agreements of the Parties. This Agreement cannot be modified
or amended, except by a writing agreed to and executed by both of the Parties.


 


17.6               Independent Contractor: It is
expressly agreed that Calixa and Astellas shall be independent contractors and
that the relationship between the Parties shall not constitute a partnership or
agency of any kind. Neither Calixa nor Astellas shall have 


 






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


 


25

















 


the
authority to make any statements, representations or commitments of any kind,
or to take any action, which shall be binding on the other Party, without the
prior written consent of the other Party.


 


17.7               Non-Assignment: This Agreement, and all
rights and obligations hereunder, shall not be assigned in whole or in part,
whether by operation by law or otherwise, by either Party to any other person
or company, except with the prior written consent of the other Party; provided that a Party may assign this Agreement without such
consent to its Affiliate or to its successor in interest in connection with the
merger or acquisition of such Party or sale of all or substantially all of such
Party’s assets. Subject to Section 11.5, Astellas and its Affiliates shall
not assign, grant or dispose of any right, title or interest in or to the
Product Patents other than to the permitted assignee of all of Astellas’ rights
in the Agreement (as permitted above). Further, if Astellas assigns the
Agreement as permitted above, Astellas (and its Affiliate, as applicable) shall
assign to such assignee in connection with such assignment all right, title and
interest in and to the Product Patents.


 


17.8               Headings: Headings included herein
are for convenience only, do not form a part of this Agreement and shall not be
used in any way to construe or interpret this Agreement.


 


17.9               Compliance with Law: Each Party
shall comply with all governmental requests directed to it in connection with
this Agreement and will provide all information and assistance necessary to
comply with said request, and failure to do so shall be considered a material
breach of this Agreement.


 


17.10         Governing Law: This Agreement shall be
governed by, and construed and interpreted in accordance with, the laws of the
State of New York, without regard to any rules of conflict of laws.


 


17.11         Dispute Resolution: All disputes,
issues or differences arising between the Parties, out of or in connection with
this Agreement (a “Dispute”), whether based on contract, tort, or other legal
theory, shall be discussed in good faith by appropriate senior executives of
each Party, who shall attempt in good faith and diligently to find a mutually
acceptable resolution to such Dispute for up to []* days. If the Parties are
not able to resolve a Dispute by the end of such discussion period, such
Dispute may be finally settled by arbitration as the Parties may agree, or by
resort to any available legal remedies. Each Party consents to the jurisdiction
and venue of the state and federal courts located in New York, New York
regarding resolution of any unresolved Dispute under this Agreement. This
Agreement has been prepared in the English language, which language shall govern
the interpretation of and any Dispute regarding the terms 


 






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


 


26

















 


of
or performance under or breach of this Agreement. The decisions of any
arbitrator(s), if the Parties agree on binding arbitration of a Dispute, shall
be final and binding on both Parties (except as they may otherwise agree in
agreeing to such arbitration).


 


17.12         Public Announcement or Disclosure of Agreement: Neither Party
shall make any public announcements or other disclosure to any Third Party of
the existence or terms of this Agreement without first obtaining the consent of
the other Party to timing and content thereof, except to the extent that such disclosure
is required by applicable law or regulation, such as to comply with securities
laws or regulations or the regulations of a securities exchange.  The Parties agree to consult and agree
reasonably on a joint press release, or two separate press releases, to be
issued by the Parties promptly after the Effective Date. Further, a Party may
disclose the existence and terms of this Agreement in confidence to its
existing investors, directors, and professional advisors and to prospective
investors, merger partners, or acquirers and their respective professional
advisors provided that such recipients agree to be bound by confidentiality
obligations preventing further disclosure of such information.


 


17.13         Performance by Affiliates and Contractors.   Any of Calixa’s obligations under this
Agreement may be satisfied by the performance of such obligation by a
sublicensee of Calixa (which may include an Affiliate of Calixa that is a
sublicensee), but Calixa shall remain obligated for the performance of all its
obligations, even if it has undertaken to have a sublicensee perform such
obligation.  Calixa shall have the right
to engage its Affiliates and Third Party contractors (such as contract research
organizations, clinical trial sites, and distributors) to perform specific
services to assist Calixa in exercising its rights and in carrying out its
respective activities or obligations under this Agreement, including for the
purpose of development and commercialization of Products in the Territory.


 


17.14   Interpretation. The term “include” or “including” as used in
this Agreement shall be exemplary and not limiting, and shall be interpreted to
mean “including without limitation”.


 






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


 


27

















 


IN
WITNESS WHEREOF, the Parties have caused their duly authorized representatives
to execute this License Agreement.


 


	
   

  	
  Astellas Pharma Inc.

  
	
   

  	
   

  
	
   

  	
  By:

  	
  /s/ Hirofumi Onosaka

  
	
   

  	
   

  	
   

  
	
   

  	
  Name:

  	
  Hirofumi Onosaka

  
	
   

  	
   

  	
   

  
	
   

  	
  Title:

  	
  Senior Corporate Officer

  
	
   

  	
   

  	
   

  
	
   

  	
  Date:

  	
  October 31, 2007

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  Calixa Therapeutics, Inc.

  
	
   

  	
   

  
	
   

  	
  By:

  	
  /s/ Eckard Weber

  
	
   

  	
   

  	
   

  
	
   

  	
  Name:

  	
  Eckard Weber

  
	
   

  	
   

  	
   

  
	
   

  	
  Title:

  	
  President and CEO

  
	
   

  	
   

  	
   

  
	
   

  	
  Date:

  	
  Nov. 1, 2007

  



 






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


 


28

















 


 


Exhibit A


 


	
  Country

  	
   

  	
  Appln.No.

  	
   

  	
  Appln.Date

  	
   

  	
  Pat.No.

  	
   

  	
  Expiry Date

  
	
  []*

  	
   

  	
  []*

  	
   

  	
  []*

  	
   

  	
  []*

  	
   

  	
  []*

  
	
  []*

  	
   

  	
  []*

  	
   

  	
  []*

  	
   

  	
  []*

  	
   

  	
  []*

  
	
  []*

  	
   

  	
  []*

  	
   

  	
  []*

  	
   

  	
  []*

  	
   

  	
  []*

  
	
  []*

  	
   

  	
  []*

  	
   

  	
  []*

  	
   

  	
  []*

  	
   

  	
  []*

  
	
  []*

  	
   

  	
  []*

  	
   

  	
  []*

  	
   

  	
  []*

  	
   

  	
  []*

  
	
  []*

  	
   

  	
  []*

  	
   

  	
  []*

  	
   

  	
  []*

  	
   

  	
  []*

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  []*

  	
   

  	
  []*

  	
   

  	
  []*

  	
   

  	
  []*

  	
   

  	
  []*

  



 






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


 


29