EXHIBIT 10.28


 






[ * ] = Certain confidential information contained in this document,
marked by brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.


 


First
Amendment to Collaboration and License Agreement


 


This First Amendment to
Collaboration and License Agreement (the “Amendment”) is entered into on April 1, 2007 (the “Amendment Effective Date”) between AFFYMAX, INC., a Delaware corporation, with its principal
place of business at 4001 Miranda Avenue, Palo Alto, CA  94304, U.S.A. (“Affymax”), and TAKEDA
PHARMACEUTICAL COMPANY LIMITED, a company incorporated under the
laws of Japan, with its principal place of business at 1-1, Doshomachi 4-chome,
Chuo-ku, Osaka, 540-8645, Japan (“Takeda”).


 


RECITALS


 


WHEREAS, Affymax and Takeda have entered into a
certain Collaboration and License Agreement dated as of February 13,
2006,  under which
Affymax has granted Takeda a certain right and license for the development and commercialization
in Japan of Affymax’s
proprietary pegylated [ * ] drug
candidate designated by Affymax as HematideTM (the “Japan
Agreement”);


 


WHEREAS, Affymax and Takeda have also entered into another Collaboration and License Agreement dated as of June 27,
2006,  under which
Affymax has granted Takeda a certain right and license for the development and commercialization
of the same drug candidate
worldwide outside Japan  (the “Global
Agreement”);


 


WHEREAS, Affymax and Takeda have been
discussing, pursuant to Section 6.8 of the Global Agreement, the amendment
of the Japan Agreement to
reflect the fact that
Takeda is now the exclusive collaborator
of the drug
candidate not only in Japan but also all over the world;


 


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


 


1.             Amendments to Section 1. 
The Parties hereby agree to amend each of the following Sections of the
Japan Agreement by replacing each such Section, in its entirety, with the
phrase “{SECTION INTENTIONALLY LEFT BLANK}”: Sections 1.70, 1.77, and
1.79.


 


2.             Addition of Section 1.84. 
The Parties hereby agree to append, at the end of Section 1, new Section 1.84
as follows:


 


1.84        “Global
Agreement” means that certain Collaboration and License Agreement between the
Parties, dated as of June 27, 2006, pursuant to which Affymax has granted
Collaborator certain rights and licenses with respect to the development and
commercialization of Hematide and the Product worldwide outside Japan.


 

















 


3.             Amendment to Section 2.4(c)(iii). 
The Parties hereby agree to amend and restate Section 2.4(c)(iii) of
the Japan Agreement by replacing such Section, in its entirety, with the
following:


 


(iii)  altering the [ * ] or otherwise proposing to conduct or conducting any
Development activities in a manner that would reasonably be expected to [ * ] development or commercialization efforts for Products [ * ] other than for
purposes of [ * ] or pursuant to a requirement
imposed by the Regulatory Authorities in the Licensed Territory or the external
monitoring board for such trial.


 


4.             Amendment to Section 3.3(d). 
The Parties hereby agree to amend and restate Section 3.3(d) of
the Japan Agreement by replacing such Section, in its entirety, with the
following:


 


(d)           using Diligent Efforts not to unreasonably adversely impact the
Development or Commercialization efforts for Products pursuant to the Global
Agreement, including without limitation, and where reasonably practicable, using and filing in the Licensed Territory
regulatory filings that are equivalent to all MAAs and related filings for
Products that are provided by Affymax and/or
Collaborator pursuant to the
Global Agreement, to ensure that all Collaborator’s filings and
specifications for Products in the Licensed Territory remain consistent, as far as reasonable, with those for
the relevant Products outside the Licensed Territory.


 


5.             Amendment to Section 3.6. 
The Parties hereby agree to amend the first sentence of Section 3.6
of the Japan Agreement by replacing such sentence, in its entirety, with the
following: “If, during the ten (10) year period following the
Effective Date,
Affymax develops a potential Backup Product(s) in the Field, Collaborator shall have a
right of first refusal to develop and commercialize such Backup Product(s) for the Licensed Territory as provided in
this Section 3.6.”


 


6.             Amendment to Section 3.6. 
The Parties hereby agree to amend the final sentence of Section 3.6
of the Japan Agreement by replacing such sentence, in its entirety, with the
following: “For clarity, if and as far as a Backup Product is developed outside the Field by Affymax, then Collaborator
shall have no rights under
this Section 3.6 with respect to such Backup Product.”


 


7.             Amendment to Section 4.1(a)(i). 
The Parties hereby agree to amend the final sentence of Section 4.1(a)(i) of the Japan Agreement by replacing such
sentence, in its entirety, with the following: “Collaborator shall have the full right, without any
additional consideration, to use any and all such data and reports supplied by
Affymax under this Section 4.1(a)(i) in connection with the
Development and/or Commercialization of the Product in the Licensed Territory, including
the incorporation of such data or reports in any MAA.”


 






[ * ] = Certain confidential information contained in this document,
marked by brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.


 

















 


8.             Amendment to Section 4.1(a)(ii). 
The Parties hereby agree to amend and restate Section 4.1(a)(ii) of
the Japan Agreement by replacing such Section, in its entirety, with the
following:


 


(ii)           Within
thirty (30) days after the Effective Date, Affymax shall provide
Collaborator with copies of all clinical data resulting from [ * ] completed or ongoing (where available) as of the
Effective Date and Controlled by Affymax. 
Thereafter, Affymax shall, in a timely manner and compliant with
requirements of the Regulatory Authority in the Licensed Territory, provide
Collaborator with copies of all preclinical, non-clinical, analytical,
manufacturing, and clinical data relating to the Product and generated by
Affymax or on behalf of Affymax by any Third Party, provided that information
regarding adverse events and serious adverse events shall be provided promptly
as set forth in Section 4.8.    Collaborator shall have the full right,
without any additional consideration, to use any and all such data supplied by
Affymax pursuant to this Section 4.1(a)(ii) and any data generated by Collaborator under the Global Agreement in
connection with the Development and/or
Commercialization of the Product pursuant to this Agreement and the
Global Agreement, including the incorporation of such data or reports in any
MAA or other regulatory filings.


 


9.             Amendment to Section 4.1(a)(iii). 
The Parties hereby agree to amend and restate Section 4.1(a)(iii) of
the Japan Agreement by replacing such Section, in its entirety, with the
following:


 


(iii)         The terms of the Global Agreement, including Section 4.1
of such agreement, will govern with respect to the Parties’ rights outside of
the Licensed Territory to access and use any clinical data generated by the
Parties pursuant to the Global Agreement. In addition, Collaborator
shall have the full right, without any additional consideration, to use any and
all such data generated by
Collaborator under this Agreement in
connection with the Development and/or Commercialization
of the Product pursuant to the Global Agreement, including the
incorporation of such data or reports in any MAA or other regulatory filing.


 


10.          Deletion of Certain Sections. 
The Parties hereby agree to delete the following Sections of the Japan
Agreement in their entirety: Sections 4.1(a)(iv), 4.1(a)(v), and 4.1(a)(vi).


 


11.          Amendment to Section 4.1(b). 
The Parties hereby agree to amend Section 4.1(b) of the Japan
Agreement by replacing such Section, in its entirety, with the phrase “{SECTION INTENTIONALLY
LEFT BLANK}”.


 


12.          Amendment to Section 4.1(c).  The Parties
hereby agree to amend and restate Section 4.1(c) of the Japan
Agreement by replacing such Section, in its entirety, with the following:


 


(c)           Data Generated by or on Behalf of Collaborator.  Collaborator shall, in a timely manner and
compliant with requirements of the FDA and the EMEA, provide Affymax with
copies of all preclinical, non-clinical, analytical, 


 






[ * ] = Certain confidential information contained in this document,
marked by brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.


 

















 


manufacturing, and clinical data relating to the Product and generated
by Collaborator or on behalf of Collaborator by any Third Party under this Agreement, provided that
information regarding adverse events and serious adverse events shall be
provided promptly as set forth in Section 4.8.  If Affymax requests that
copies of such data be provided in compliance with requirements of other
Regulatory Authorities pursuant to the
Global Agreement, Collaborator shall reasonably consider such
request.  Affymax shall have the full
right, without any additional consideration, to use any and all such data
supplied by Collaborator pursuant to this Section 4.1(c) in
connection with the Development of the Product pursuant to this Agreement and
the Global Agreement and/or in connection
with the Commercialization of the Product in U.S. pursuant to the Global
Agreement, including the incorporation of such data or reports in any
MAA or other regulatory filings.


 


13.          Amendment to Section 4.1(d). 
The Parties hereby agree to amend and restate Section 4.1(d) of
the Japan Agreement by replacing such Section, in its entirety, with the phrase
“{SECTION INTENTIONALLY LEFT BLANK}”.


 


14.          Amendment to Section 4.2(b).  The Parties
hereby agree to amend and restate Section 4.2(b) of the Japan
Agreement by replacing such Section, in its entirety, with the following:


 


(b)           Rights of Reference to Regulatory
Materials.   Each Party hereby
grants to the other Party a right of reference to all Regulatory Materials
filed by such Party pursuant to this Agreement and/or the Global
Agreement for Product as follows: 
The right of reference granted to Affymax herein shall be solely for the
purpose of Affymax or its Affiliates obtaining Regulatory Approval in U.S. for the Product pursuant to the
Global Agreement.  The right of reference
granted to Collaborator herein shall be solely for the purpose of obtaining
Regulatory Approval for the Products in and
outside the Licensed Territory
pursuant to this Agreement and/or the Global Agreement. For the avoidance of doubt, Collaborator shall
have a right of reference, for the purpose of obtaining the Regulatory Approval
for the Products in the Licensed Territory pursuant hereto, to all Regulatory
Materials filed by Collaborator pursuant to the Global Agreement, and vice
versa.


 


15.          Amendment to Section 4.2(c)(iv).  The Parties
hereby agree to amend and restate Section 4.2(c)(iv) of the Japan
Agreement by replacing such Section, in its entirety, with the following:


 


(iv)          The terms of the Global Agreement, including Section 4.2(a) of
such agreement, will govern the right to file Regulatory Materials or
Regulatory Approvals regarding the Product outside the Licensed Territory.


 


16.          Amendment to Section 4.5. 
The Parties hereby agree to amend and restate the final sentence of Section 4.5
of the Japan Agreement by replacing such sentence, in its entirety, with the
following: “The terms of the Global Agreement, including Section 4.6
of such agreement, 


 






[ * ] = Certain confidential information contained in this document,
marked by brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.


 

















 


will
govern the right and procedures for the communication regarding the Product
with any Regulatory Authorities outside the Licensed Territory.”


 


17.          Amendment to Section 4.6. 
The Parties hereby agree to amend and restate the final sentence of Section 4.6
of the Japan Agreement by replacing such sentence, in its entirety, with the
following: “The terms of the Global Agreement, including Section 4.2
of such agreement, will govern the filing of any Regulatory Materials for
Peptide, [ * ], Hematide and/or Product outside
of the Licensed Territory.”


 


18.          Amendment to Section 4.8. 
The Parties hereby agree to amend and restate the first sentence of Section 4.8
of the Japan Agreement by replacing such sentence, in its entirety, with the
following: “The Parties agree that Collaborator shall be primarily responsible
for the monitoring of all clinical experiences and filing of all required
reports throughout clinical Development and Commercialization of the Product in
the Licensed Territory,  and that the primary responsibility for the
monitoring of all clinical experiences and filing of all required reports
concerning the Product in the Affymax Territory will be as set forth in the
Global Agreement.”


 


19.          Amendment to Sections 4.8(c) and (d). 
The Parties hereby agree to amend and restate Sections 4.8(c) and (d) of
the Japan Agreement by replacing such Sections, in their entirety, with the
following:


 


(c)           provides that Collaborator shall have regulatory
reporting responsibilities in the Licensed Territory, and the Party who shall have regulatory reporting
responsibilities in the Affymax Territory shall be as set forth in the
Global Agreement;


 


(d)           provides that Collaborator shall manage the global
safety database;


 


20.          Amendment to Section 4.9. 
The Parties hereby agree to amend and restate  Section 4.9 of the Japan Agreement by
replacing such Section, in its entirety, with the following:


 


4.9          Regulatory Authority
Communications Received by a Party.  Each Party shall keep the other Party
informed, in a timely manner and in any event in compliance with the reporting
requirements of any Regulatory Authorities, of notification of any action by, or
notification or other information which the first Party receives (directly or
indirectly) from any such Regulatory Authority which: (a) raises any [ * ] of the Product; (b) indicates or suggests [ * ] in connection with the Product; (c) is reasonably
likely to lead to a [ * ] of the
Product; or (d) relates to [ * ] with
respect to the Product, [ * ], and
which may have [ * ] the [ * ].
Preparation and submission of the response to such communication outside
the Licensed Territory shall be as set forth in the Global Agreement.
Collaborator shall be
responsible for preparing and submitting the response to the communication to the
Regulatory Authorities in the Licensed Territory.  However,
before submitting such response to a Regulatory Authority regarding the
communication, Affymax shall have an opportunity to comment on the 


 






[ * ] = Certain confidential information contained in this document,
marked by brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.


 

















 


response.  In
the event the Parties disagree concerning the form or content of a response to
a Regulatory Authority in the Licensed Territory, Collaborator shall decide the appropriate form and
content of such response. Affymax shall fully cooperate with and assist the
Collaborator in complying with such regulatory obligations and communications,
including by providing to the Collaborator, within two (2) Business Days
after a request or as quickly as practicable thereafter, such information and
documentation in Affymax’s possession as may be necessary or helpful for the
Collaborator to prepare a response to an inquiry from a Regulatory
Authority.  For clarity, each Party’s
obligations under this Section 4.8 shall apply to any such communications regarding the
matters referred to above received by such Party’s Affiliate(s), contractors,
partners, or other collaborators as if such communications had been received by
such Party directly.


 


21.          Amendment to Section 4.11.  The Parties
hereby agree to amend and restate Section 4.11 of the Japan Agreement by
replacing such Section, in its entirety, with the following:


 


4.11        Recalls and Voluntary
Withdrawals.  The Parties shall exchange their internal standard
operating procedures (“SOPs”) for
conducting product recalls reasonably in advance of the First Commercial Sale
of any Product in the Licensed Territory, and shall discuss and resolve any
conflicts between such SOPs and issues relating thereto promptly after such
exchange.  If either Party becomes aware
of information relating to any Product that indicates that a unit or batch of
Finished Product or Bulk Hematide may not conform to the specifications
therefor, or that potential adulteration, misbranding, and/or other issues have
arisen that relate to the safety or efficacy of Products, it shall promptly so
notify the other Party.  The Joint
Committee shall meet to discuss such circumstances and to consider appropriate
courses of action, which shall be consistent with the internal SOP of the Party
having the right to control such recall pursuant to this Section 4.11.
Collaborator shall have the right and responsibility to control any product recall, field correction,
or withdrawal of any Product in the Licensed Territory that is required by
Regulatory Authorities in the Licensed Territory, and the allocation of
expenses incurred in connection with such recall between the Parties shall be made as follows: (i) if the recall
is due to a manufacturing defect in accordance with then prevailing U.S.
product liability Laws, unless otherwise agreed upon by the Parties in the
Supply Agreement (as defined in Section 7.3
hereof) for Bulk Hematide, then Affymax shall bear all such expenses, (ii) if
the recall is due to a manufacturing defect in accordance with then prevailing
U.S. product liability Laws, unless otherwise agreed upon by the Parties in the
Supply Agreement of Finished Product (other than due to manufacturing defect of
Bulk Hematide), then Collaborator shall bear all such expenses, (iii) if
the recall is due to both of (i) and (ii), then the Parties shall share
all such expenses proportionately and (iv) otherwise, 100% to Collaborator
to the extent attributable to a recall in the Licensed Territory, unless otherwise may be agreed in the Supply
Agreement. In addition,
Collaborator shall have the right, at its discretion, to conduct any product
recall, field correction or withdrawal of any Product in the Licensed Territory
that is not so required by such Regulatory 


 






[ * ] = Certain confidential information contained in this document,
marked by brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.


 

















 


Authorities but that Collaborator deems to be appropriate, with the
allocation of expenses incurred in connection with such recall between the
Parties to be as set
forth in the immediately preceding
sentence. Collaborator
shall maintain complete and accurate records of any recall in the Licensed
Territory for such periods as may be required by applicable Laws, but no event
for less than three (3) years.


 


22.          Amendment to Section 6.3.  The Parties
hereby agree to amend and restate Section 6.3 of the Japan Agreement by replacing
such Section, in its entirety, with the following:


 


6.3          License to Affymax under
Collaborator Technology.  Subject to
the terms and conditions of this Agreement and the Global Agreement, Collaborator hereby grants to Affymax a
non-exclusive, royalty-free license under the Collaborator Technology to
develop, use, sell, offer for sale, make, have made, and import the Product or
the Peptide or the Bulk Hematide or the Finished Product for the purpose of
Development and Commercialization of the Product anywhere in the world where Affymax has or comes to have a right to Develop
and Commercialize the Product pursuant to this Agreement or the Global
Agreement, as the case may be.  Such
license shall be sublicenseable by Affymax to any Affiliate of Affymax.  Such license shall also be sublicenseable by
Affymax to any Third Party with written notification to Collaborator promptly
following the grant of such sublicense.


 


23.          Amendment to Section 7.4.  The Parties
hereby agree to amend and restate Section 7.4 of the Japan Agreement by
replacing such Section, in its entirety, with the following:


 


7.4          Finished Product.    Collaborator shall be responsible for, at its
own cost, the formulation, filling, finishing, testing and final release of the
Finished Products for Development and Commercialization in the Licensed
Territory.  Collaborator shall have the right
to pursue in its sole discretion the formulation for the Product, including a
formulation which is different from that utilized for the Product pursuant to the Global Agreement for use
in the Affymax Territory.  Collaborator shall be solely responsible
for obtaining, at its expense, any licenses deemed by it to be necessary or
desirable to such formulation and/or any aspect of the Finished Manufacture which is different from that utilized
for the Product pursuant to the Global
Agreement for use in the Affymax Territory.


 


24.          Amendment to Section 8.2.  The Parties
hereby agree to amend and restate the second row of the table set forth in Section 8.2
of the Japan Agreement by replacing such row, in its entirety, with the
following:


 




	
  [ *]

  	
   

  	
  $

  	
  [*]

  	
   

  






 






[ * ] = Certain confidential information contained in this document,
marked by brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.


 

















 


25.          Amendment to Section 8.2.  The Parties
hereby agree to amend and restate the final row of the table set forth in Section 8.2
of the Japan Agreement by replacing such row, in its entirety, with the
following:


 




	
  *
  “Initiation”, as used in this milestone event
  chart, means the first dosing of the first human subject. 

  
	
   

  	
   

  	
   

  
	
  **
  “Completion” means, with respect to a given clinical trial, and as used in the
  description of the milestone events, the date on which all data has
  been collected in such trial for the last subject. 

  
	
   

  	
   

  	
   

  
	
  ***
  As used in this milestone event chart, [ * ] shall include receipt of final written notice from the Regulatory Authority that,
  based on results obtained outside the Licensed Territory, [ * ] must be
  conducted within the Licensed Territory to obtain Regulatory Approval of
  the Product in the Licensed Territory.

  






 


26.          Amendment to Section 9.3(a). 
The Parties hereby agree to amend the Section 9.3(a) of the
Japan Agreement by deleting the final sentence of such Section in its
entirety.


 


27.          Amendment to Section 9.3(c).  The Parties
hereby agree to amend and restate Section 9.3(c) of the Japan
Agreement by replacing such Section, in its entirety, with the following:


 


(c)           Joint Patents.  With
respect to any potentially patentable Joint Invention, the Parties shall meet
and agree upon which Party shall prosecute and maintain patent applications
covering such Joint Invention (any such patent application and any patents
issuing therefrom a “Joint Patent”) in particular
countries and jurisdictions throughout the world.  It is the intention of the Parties that,
unless otherwise agreed, Collaborator would prosecute and maintain any Joint
Patents anywhere in the world other than
the U.S., and Affymax would prosecute and maintain the Joint Patents in
the U.S., subject to the Parties
coordinating their efforts as appropriate to make such prosecution activities
as efficient, convenient and harmonious as possible.  The external costs of such prosecution of the Joint Patents shall be shared
equally by the Parties and the internal costs of such prosecution of the Joint
Patents shall be borne by the Party that prosecutes a patent application
in the Joint Patents (the “Prosecuting Party”); provided, however, in the Licensed Territory
only, Collaborator shall bear both internal and external costs and
expenses incurred with respect to
the prosecution of such patent application, except as otherwise provided
below.  The Prosecuting Party shall 


 






[ * ] = Certain confidential information contained in this document,
marked by brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.


 

















 


provide the other Party reasonable opportunity to review and comment on
such prosecution efforts regarding the applicable Joint Patents in the
particular jurisdictions, and such other Party shall provide the Prosecuting
Party reasonable assistance in such efforts. 
The Prosecuting Party shall provide the other Party with a copy of all
material communications from any patent authority in the applicable
jurisdictions regarding the Joint Patent being prosecuted by such Party, and
shall provide drafts of any material filings or responses to be made to such
patent authorities a reasonable amount of time in advance of submitting such
filings or responses.  In particular,
each Party agrees to provide the other Party with all information necessary or
desirable to enable the other Party to comply with the duty of candor/duty of
disclosure requirements of any patent authority.  Except to the extent a particular Party is
restricted by the licenses granted to the other Party and/or the other
covenants contained in the Agreement, each Party shall be entitled to practice,
and grant to Third Parties and its Affiliates the right to practice, the Joint
Patents and all Joint Inventions without restriction or an obligation to
account to the other Party, and the other Party shall consent, without
additional consideration, to any and all such licenses. Either Party may
determine that it is no longer interested in supporting the continued
prosecution or maintenance of a particular Joint Patent in a country or
jurisdiction, in which case: (i) such Party may elect to cease its
ownership interest in such Joint Patents and shall, if requested in writing by
the other Party, assign its ownership interest in such Joint Patent in such
country or jurisdiction to the other Party for no additional consideration, and
(ii) thereafter, the electing Party shall be released from any obligations
with regard to such Joint Patents and any such Joint Patent would thereafter be
deemed a Affymax Patent in the case of assignment to Affymax, or a Collaborator
Patent in the case of assignment to Collaborator.


 


28.          Amendment to Section 9.5(b)(i).  The Parties
hereby agree to amend and restate Section 9.5(b)(i) of the Japan
Agreement by replacing such Section, in its entirety, with the following:


 


(i)            If
a Third Party infringes any Affymax Patent or Joint Patent in the Licensed
Territory by making, using, importing, offering for sale or selling the
Product, Hematide, [ * ] or any
product containing the Peptide, or [ * ] (such
activities, “Product Infringement”),
each Party shall so notify the other Party as provided in Section 9.5(a),
which such notice shall include all Information available to the other Party
regarding such alleged infringement and Affymax shall have the first right, but
not the obligation, to bring an appropriate suit or other action against any
person or entity engaged in such Product Infringement in the Licensed
Territory, subject to Section 9.5(b)(ii) below, at its expense.  Affymax shall have a period of one hundred
twenty (120) days after such notification to or by Affymax, to elect to so
enforce such Affymax Patent or Joint Patent. 
In the event it does not so elect, it shall so notify Collaborator in
writing during such one hundred twenty (120) day time period, and Collaborator
shall have the right, but not the obligation, to commence a suit or take action
to enforce the applicable Affymax Patent or Joint Patent against such Third
Party perpetrating such Product Infringement at its expense, unless Affymax 


 






[ * ] = Certain confidential information contained in this document,
marked by brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.


 

















 


demonstrates to the Collaborator in writing a reasonable business basis
for not enforcing such Affymax Patents or Joint Patents against such Product Infringement during such time period,
in which case Collaborator shall not have the right to so commence such suit or
take such action to enforce the applicable Affymax Patent or Joint Patent
without Affymax’s prior written consent, provided that if such basis is so
demonstrated, that the Parties shall re-evaluate upon Collaborator’s reasonable
request, from time to time, whether such basis continues to apply or whether at
such time Collaborator may exercise such right. Each Party shall provide to the
Party enforcing any such rights under this Section 9.5(b)(i) reasonable
assistance in such enforcement, at such enforcing Party’s request and expense,
including joining such action as a party plaintiff if required by applicable
Law to pursue such action.  The enforcing
Party shall keep the other Party regularly informed of the status and progress
of such enforcement efforts, and shall reasonably consider the other Party’s comments on any such efforts.  Each Party shall bear all of its own internal
costs incurred in connection with its activities under this Section 9.5(b)(i).


 


29.          Amendment to Sections 9.5(c) and (d). 
The Parties hereby agree to amend and restate Sections 9.5(c) and (d) of
the Japan Agreement by replacing such Sections, in their entirety, with the
following:


 


(c)           Infringement
of Affymax Patents or Joint Patents in the Affymax Territory.  For any and all infringement of Affymax Patents
or Joint Patents anywhere in the Affymax Territory, the rights and
responsibilities of the Parties shall be governed by Section 9.5(b) of
the Global Agreement.


 


(d)           Product Infringement of
Collaborator Patents (other than Joint Patents) in the Affymax Territory.  For any and all infringement of Affymax
Patents other than Joint Patents anywhere in the Affymax Territory, the rights
and responsibilities of the Parties shall be governed by Section 9.5(c) of
the Global Agreement.


 


30.          Amendment to Section 9.5(g)(ii).  The Parties
hereby agree to amend and restate Section 9.5(g)(ii) of the Japan
Agreement by replacing such Section, in its entirety, with the following:


 


(ii)           the
portion of any such remaining amounts that represents recovery for infringement
in the Affymax Territory shall be allocated according to the applicable terms
of the Global Agreement.


 


31.          Amendment to Section 11.1. 
The Parties hereby agree to amend and restate clause (a) of Section 11.1
of the Japan Agreement by replacing such Section, in its entirety, with the
following: “(a) the development, manufacture, storage, handling, use,
promotion, sale, offer for sale, and importation of Products by Affymax or its
sublicensees (other than Collaborator) or Affiliates in the Affymax Territory and/or the
Development activities conducted by or on behalf of Affymax (or its sublicensees, other than
Collaborator, or Affiliates in the Affymax Territory, 


 






[ * ] = Certain confidential information contained in this document,
marked by brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.


 

















 


if
any), including without limitation the development activities prior to or
ongoing as of the Effective Date”.


 


32.          Amendment to Section 11.2. 
The Parties hereby agree to amend and restate clause (i) of Section 11.2
of the Japan Agreement by replacing such Section, in its entirety, with the
following: “(i) the development, manufacture, storage, handling, use,
promotion, sale, offer for sale, and importation of Products by Affymax or its
sublicensees (other than Collaborator) or Affiliates in the Affymax Territory and/or the
Development activities conducted by or on behalf of Affymax (or its sublicensees, other than
Collaborator, or Affiliates in the Affymax Territory, if any), including without
limitation the development activities prior to or ongoing as of the Effective
Date”.


 


33.          Amendment to Section 12.4. 
The Parties hereby agree to amend the Section 12.4 of the Japan
Agreement by deleting the final sentence of such Section in its entirety.


 


34.          Counterparts. 
This Amendment may be executed in two or more counterparts, each of
which will be deemed an original, but all of which together will constitute one
and the same instrument.


 


35.          Effectiveness. 
This Amendment will become effective upon the execution hereof by both
Parties.


 


36.          Continuing Effect. Other than as set forth in this
Amendment, all of the terms and conditions of the Agreement will continue in
full force and effect.


 


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


 


	
  TAKEDA PHARMACEUTICAL COMPANY 

  LIMITED  

  	
   

  	
  AFFYMAX, INC.  

  
	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ Yasuhiko Yamanaka  

  	
   

  	
  By:

  	
  /s/ Arlene Morris

  
	
   

  	
   

  	
   

  
	
  Name:

  	
  Yasuhiko Yamanaka  

  	
   

  	
  Name: Arlene
  Morris 

  
	
   

  	
   

  	
   

  
	
  Title:

  	
  Corporate Officer, General Manager, 

  Pharmaceutical Marketing Division

  	
   

  	
  Title:   President &
  CEO

  
						



 






[ * ] = Certain confidential information contained in this document,
marked by brackets, has been omitted and filed separately with the Securities
and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.