EXHIBIT 10.24


 






[ * ] = 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 406 of the Securities Act of
1933, as amended.


 


COLLABORATION
AND LICENSE AGREEMENT


 


This COLLABORATION AND LICENSE
AGREEMENT (the “Agreement”)
is entered into on February 13, 2006 (the “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 a place of business at 1-1, Doshomachi
4-chome, Chuo-ku, Osaka, 540-8645, Japan (“Collaborator”).  Affymax and Collaborator are sometimes
referred to herein individually as a “Party” and
collectively as the “Parties”.


 


RECITALS


 


WHEREAS, Affymax is developing its proprietary
pegylated [ * ] drug candidate designated by
Affymax as HematideTM
for the treatment of anemia in patients with chronic kidney disease and cancer;


 


WHEREAS, Collaborator possesses substantial
resources and expertise in the development, marketing, and commercialization of
pharmaceutical products in Japan;


 


WHEREAS, Collaborator desires to obtain
exclusive rights to develop further and commercialize Hematide in Japan, and
Affymax is willing to grant such rights on the terms and conditions hereof.


 


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


 


1

















 


TABLE OF CONTENTS


 


	
   

  	
   

  	
   

  	
  PAGE

  
	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE 1

  	
  DEFINITIONS

  	
  2

  
	
   

  	
  1.1

  	
  “Affiliate”

  	
  2

  
	
   

  	
  1.2

  	
  “Affymax House
  Marks”

  	
  2

  
	
   

  	
  1.3

  	
  “Affymax
  Know-How”

  	
  2

  
	
   

  	
  1.4

  	
  “Affymax Patent”

  	
  3

  
	
   

  	
  1.5

  	
  “Affymax
  Technology”

  	
  3

  
	
   

  	
  1.6

  	
  “Affymax
  Territory”

  	
  3

  
	
   

  	
  1.7

  	
  “Alternative
  ESA”

  	
  3

  
	
   

  	
  1.8

  	
  “Backup Product”

  	
  3

  
	
   

  	
  1.9

  	
  “Bulk Hematide”

  	
  3

  
	
   

  	
  1.10

  	
  “Claims”

  	
  3

  
	
   

  	
  1.11

  	
  “CTA”

  	
  3

  
	
   

  	
  1.12

  	
  “Collaborator
  Know-How”

  	
  4

  
	
   

  	
  1.13

  	
  “Collaborator
  Patent”

  	
  4

  
	
   

  	
  1.14

  	
  “Collaborator
  Technology”

  	
  4

  
	
   

  	
  1.15

  	
  “Commercialization”

  	
  4

  
	
   

  	
  1.16

  	
  “Confidential
  Information”

  	
  4

  
	
   

  	
  1.17

  	
  “Control”

  	
  4

  
	
   

  	
  1.18

  	
  “Develop” or
  “Development”

  	
  5

  
	
   

  	
  1.19

  	
  “Development
  Plan”

  	
  5

  
	
   

  	
  1.20

  	
  “Diligent
  Efforts”

  	
  5

  
	
   

  	
  1.21

  	
  “[ * ]”

  	
  5

  
	
   

  	
  1.22

  	
  “Dollar”

  	
  5

  
	
   

  	
  1.23

  	
  “EMEA”

  	
  5

  
	
   

  	
  1.24

  	
  “ESA”

  	
  6

  
	
   

  	
  1.25

  	
  “FDA”

  	
  6

  
	
   

  	
  1.26

  	
  “FD&C Act”

  	
  6

  
	
   

  	
  1.27

  	
  “Field”

  	
  6

  
	
   

  	
  1.28

  	
  “Finished
  Manufacture”

  	
  6

  
					



 






[ * ] = 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 406 of the Securities Act of
1933, as amended.


 


i

















 


TABLE OF CONTENTS


(CONTINUED)


 


	
   

  	
   

  	
   

  	
  PAGE

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.29

  	
  “Finished
  Product”

  	
  6

  
	
   

  	
  1.30

  	
  “First
  Commercial Sale”

  	
  6

  
	
   

  	
  1.31

  	
  “Formulation
  Technology”

  	
  6

  
	
   

  	
  1.32

  	
  “Good Clinical
  Practices” or “GCP”

  	
  6

  
	
   

  	
  1.33

  	
  “Good Laboratory
  Practices” or “GLP”

  	
  7

  
	
   

  	
  1.34

  	
  “Good
  Manufacturing Practices” or “GMP”

  	
  7

  
	
   

  	
  1.35

  	
  “Governmental
  Authority”

  	
  7

  
	
   

  	
  1.36

  	
  “Hematide”

  	
  7

  
	
   

  	
  1.37

  	
  “IND”

  	
  7

  
	
   

  	
  1.38

  	
  “Information”

  	
  7

  
	
   

  	
  1.39

  	
  “Initial
  Indications”

  	
  8

  
	
   

  	
  1.40

  	
  “Joint
  Committee”

  	
  8

  
	
   

  	
  1.41

  	
  “Joint
  Inventions”

  	
  8

  
	
   

  	
  1.42

  	
  “Joint Patent”

  	
  8

  
	
   

  	
  1.43

  	
  “Laws”

  	
  8

  
	
   

  	
  1.44

  	
  “Licensed
  Territory”

  	
  8

  
	
   

  	
  1.45

  	
  “Manufacturing
  Costs”

  	
  8

  
	
   

  	
  1.46

  	
  “Marketing
  Authorization Application” or “MAA”

  	
  10

  
	
   

  	
  1.47

  	
  “MHLW”

  	
  10

  
	
   

  	
  1.48

  	
  “Net Sales”

  	
  10

  
	
   

  	
  1.49

  	
  “Oncology
  Indications”

  	
  11

  
	
   

  	
  1.50

  	
  “Patents”

  	
  11

  
	
   

  	
  1.51

  	
  “Patent Term
  Extension”

  	
  12

  
	
   

  	
  1.52

  	
  “Peptide”

  	
  12

  
	
   

  	
  1.53

  	
  “Phase I
  Clinical Trial”

  	
  12

  
	
   

  	
  1.54

  	
  “Phase II
  Clinical Trial”

  	
  12

  
	
   

  	
  1.56

  	
  “Phase IIIB Clinical
  Trial”

  	
  12

  



 






[ * ] = 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 406 of the Securities Act of
1933, as amended.


 


ii

















 


TABLE OF CONTENTS


(CONTINUED)


 


	
   

  	
   

  	
   

  	
  PAGE

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  1.57

  	
  “Phase IV
  Clinical Trial”

  	
  12

  
	
   

  	
  1.58

  	
  “Pricing
  Approval”

  	
  13

  
	
   

  	
  1.59

  	
  “Product”

  	
  13

  
	
   

  	
  1.60

  	
  “Product
  Complaint”

  	
  13

  
	
   

  	
  1.61

  	
  “Product
  Infringement”

  	
  13

  
	
   

  	
  1.63

  	
  “Promotional
  Materials”

  	
  13

  
	
   

  	
  1.64

  	
  “Reagent”

  	
  13

  
	
   

  	
  1.65

  	
  “Regulatory
  Approvals”

  	
  14

  
	
   

  	
  1.66

  	
  “Regulatory
  Authority”

  	
  14

  
	
   

  	
  1.67

  	
  “Regulatory
  Exclusivity”

  	
  14

  
	
   

  	
  1.68

  	
  “Regulatory
  Materials”

  	
  14

  
	
   

  	
  1.69

  	
  “Renal
  Indications”

  	
  14

  
	
   

  	
  1.70

  	
  “Required Third
  Party Data”

  	
  14

  
	
   

  	
  1.72

  	
  “Stock Purchase
  Agreement”

  	
  14

  
	
   

  	
  1.73

  	
  “Term”

  	
  15

  
	
   

  	
  1.74

  	
  “Territory”

  	
  15

  
	
   

  	
  1.75

  	
  “Third
  Indication”

  	
  15

  
	
   

  	
  1.76

  	
  “Third Party”

  	
  15

  
	
   

  	
  1.77

  	
  “Third Party
  Data”

  	
  15

  
	
   

  	
  1.78

  	
  “Third Party
  License Agreements”

  	
  15

  
	
   

  	
  1.79

  	
  “Third Party
  Partner”

  	
  15

  
	
   

  	
  1.80

  	
  “U.S.”

  	
  15

  
	
   

  	
  1.81

  	
  “Valid Claim”

  	
  15

  
	
   

  	
  1.82

  	
  “Yakka”

  	
  15

  
	
  ARTICLE 2

  	
  MANAGEMENT

  	
  16

  
	
   

  	
  2.1

  	
  Joint Committee

  	
  16

  
	
   

  	
  2.2

  	
  Joint Committee
  Membership

  	
  17

  



 






[ * ] = 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 406 of the Securities Act of
1933, as amended.


 


iii

















 


TABLE OF CONTENTS


(CONTINUED)


 


	
   

  	
   

  	
   

  	
  PAGE

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  2.3

  	
  Joint Committee
  Meetings and Agendas

  	
  18

  
	
   

  	
  2.4

  	
  Joint Committee Decisions
  and Actions

  	
  19

  
	
   

  	
  2.5

  	
  Project
  Coordinators

  	
  20

  
	
   

  	
  2.6

  	
  Collaboration
  Guidelines

  	
  20

  
	
  ARTICLE 3

  	
  PRODUCT
  DEVELOPMENT

  	
  20

  
	
   

  	
  3.1

  	
  Overview

  	
  20

  
	
   

  	
  3.2

  	
  Development Plan

  	
  21

  
	
   

  	
  3.3

  	
  Principles of
  Product Development

  	
  22

  
	
   

  	
  3.4

  	
  Collaborator’s
  Performance

  	
  22

  
	
   

  	
  3.5

  	
  Records, Reports
  and Information

  	
  23

  
	
   

  	
  3.6

  	
  Right of First
  Refusal to Backup Product Developed in the Field

  	
  23

  
	
  ARTICLE 4

  	
  REGULATORY
  MATTERS

  	
  24

  
	
   

  	
  4.1

  	
  Transfer of Data
  and Regulatory Materials

  	
  24

  
	
   

  	
  4.2

  	
  Regulatory
  Filings and Approvals

  	
  29

  
	
   

  	
  4.3

  	
  Filings for
  Regulatory Exclusivity

  	
  31

  
	
   

  	
  4.4

  	
  Regulatory Costs

  	
  31

  
	
   

  	
  4.5

  	
  Communications

  	
  31

  
	
   

  	
  4.6

  	
  Collaborator
  Regulatory Filings

  	
  32

  
	
   

  	
  4.7

  	
  No Harmful
  Actions

  	
  32

  
	
   

  	
  4.8

  	
  Adverse Event
  Reporting and Safety Data Exchange

  	
  33

  
	
   

  	
  4.9

  	
  Regulatory
  Authority Communications Received by a Party

  	
  34

  
	
   

  	
  4.10

  	
  Regulatory
  Inspection or Audit

  	
  35

  
	
   

  	
  4.11

  	
  Recalls and
  Voluntary Withdrawals

  	
  36

  
	
  ARTICLE 5

  	
  COMMERCIALIZATION

  	
  37

  
	
   

  	
  5.1

  	
  Commercialization
  in the Licensed Territory

  	
  37

  
	
   

  	
  5.2

  	
  Pricing
  Approvals in the Licensed Territory

  	
  37

  
	
   

  	
  5.3

  	
  Pricing of the
  Product in the Licensed Territory

  	
  38

  



 






[ * ] = 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 406 of the Securities Act of
1933, as amended.


 


iv

















 


TABLE OF CONTENTS


(CONTINUED)


 


	
   

  	
   

  	
   

  	
  PAGE

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  5.4

  	
  Collaborator
  Performance

  	
  38

  
	
   

  	
  5.5

  	
  Compliance

  	
  38

  
	
   

  	
  5.6

  	
  Product
  Trademark and Affymax House Marks

  	
  39

  
	
  ARTICLE 6

  	
  LICENSES AND
  EXCLUSIVITY

  	
  40

  
	
   

  	
  6.1

  	
  Licenses to
  Collaborator under Affymax Technology

  	
  40

  
	
   

  	
  6.2

  	
  Limited License
  for Affymax House Marks

  	
  40

  
	
   

  	
  6.3

  	
  License to
  Affymax under Collaborator Technology

  	
  41

  
	
   

  	
  6.4

  	
  Negative
  Covenant

  	
  41

  
	
   

  	
  6.5

  	
  No Implied
  Licenses

  	
  41

  
	
   

  	
  6.6

  	
  Exclusivity

  	
  41

  
	
   

  	
  6.7

  	
  Third Party
  Licenses

  	
  42

  
	
  ARTICLE 7

  	
  MANUFACTURE AND
  SUPPLY

  	
  42

  
	
   

  	
  7.1

  	
  Roles of the
  Parties

  	
  42

  
	
   

  	
  7.2

  	
  Preclinical and
  Clinical Supply of Bulk Hematide

  	
  42

  
	
   

  	
  7.3

  	
  Commercial
  Supply of Bulk Hematide

  	
  43

  
	
   

  	
  7.4

  	
  Finished Product

  	
  44

  
	
   

  	
  7.5

  	
  Comparator Drugs

  	
  44

  
	
   

  	
  7.6

  	
  Audit

  	
  44

  
	
   

  	
  7.7

  	
  Collaborator
  Audit Right of Bulk Hematide Facility

  	
  45

  
	
   

  	
  7.8

  	
  Quality
  Agreement

  	
  46

  
	
  ARTICLE 8

  	
  COMPENSATION

  	
  46

  
	
   

  	
  8.1

  	
  License Fee

  	
  46

  
	
   

  	
  8.2

  	
  Clinical
  Milestone Payments

  	
  47

  
	
   

  	
  8.3

  	
  Royalties

  	
  48

  
	
   

  	
  8.4

  	
  Existing and
  Future Third Party Royalties

  	
  50

  
	
   

  	
  8.5

  	
  Taxes

  	
  51

  
	
   

  	
  8.6

  	
  Foreign Exchange

  	
  52

  



 






[ * ] = 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 406 of the Securities Act of
1933, as amended.


 


v

















 


TABLE OF CONTENTS


(CONTINUED)


 


	
   

  	
   

  	
   

  	
  PAGE

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  8.7

  	
  Late Payments

  	
  52

  
	
   

  	
  8.8

  	
  Records; Audits

  	
  52

  
	
  ARTICLE 9

  	
  INTELLECTUAL
  PROPERTY MATTERS

  	
  53

  
	
   

  	
  9.1

  	
  Ownership of
  Inventions

  	
  53

  
	
   

  	
  9.2

  	
  Disclosure of
  Inventions

  	
  53

  
	
   

  	
  9.3

  	
  Prosecution of
  Patents

  	
  54

  
	
   

  	
  9.4

  	
  Patent Term
  Extensions in the Licensed Territory

  	
  57

  
	
   

  	
  9.5

  	
  Infringement of
  Patents by Third Parties

  	
  58

  
	
   

  	
  9.6

  	
  Infringement of
  Third Party Rights in the Licensed Territory

  	
  63

  
	
   

  	
  9.7

  	
  Patent Marking

  	
  64

  
	
   

  	
  9.8

  	
  Infringement of Trademarks
  by Third Parties

  	
  64

  
	
   

  	
  9.9

  	
  Patent
  Oppositions and Other Proceedings

  	
  64

  
	
   

  	
  9.10

  	
  Parties’ Patent
  Rights

  	
  65

  
	
   

  	
  9.11

  	
  Orange Book
  Listing, Compendial Listing

  	
  66

  
	
   

  	
  9.12

  	
  Registration of
  Exclusive License

  	
  66

  
	
   

  	
  9.13

  	
  Certain Patent
  Matters

  	
  66

  
	
  ARTICLE 10

  	
  REPRESENTATIONS
  AND WARRANTIES

  	
  66

  
	
   

  	
  10.1

  	
  Mutual
  Representations and Warranties

  	
  66

  
	
   

  	
  10.2

  	
  Additional
  Representations, Warranties and Covenants of Affymax

  	
  67

  
	
   

  	
  10.3

  	
  Disclaimer

  	
  69

  
	
   

  	
  10.4

  	
  No Other
  Representations or Warranties

  	
  70

  
	
  ARTICLE 11

  	
  INDEMNIFICATION

  	
  70

  
	
   

  	
  11.1

  	
  Indemnification
  by Affymax

  	
  70

  
	
   

  	
  11.2

  	
  Indemnification
  by Collaborator

  	
  71

  
	
   

  	
  11.3

  	
  Indemnification
  Procedures

  	
  71

  
	
   

  	
  11.4

  	
  Limitation of
  Liability

  	
  72

  
	
   

  	
  11.5

  	
  Insurance

  	
  72

  



 






[ * ] = 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 406 of the Securities Act of
1933, as amended.


 


vi

















 


TABLE OF CONTENTS


(CONTINUED)


 


	
   

  	
   

  	
   

  	
  PAGE

  
	
   

  	
   

  	
   

  	
   

  
	
  ARTICLE 12

  	
  CONFIDENTIALITY

  	
  73

  
	
   

  	
  12.1

  	
  Confidentiality

  	
  73

  
	
   

  	
  12.2

  	
  Authorized
  Disclosure

  	
  74

  
	
   

  	
  12.3

  	
  Publicity; Terms
  of Agreement

  	
  75

  
	
   

  	
  12.4

  	
  Publications

  	
  76

  
	
  ARTICLE 13

  	
  TERM AND
  TERMINATION

  	
  77

  
	
   

  	
  13.1

  	
  Term

  	
  77

  
	
   

  	
  13.2

  	
  Early
  Termination

  	
  77

  
	
   

  	
  13.3

  	
  Effect of
  Termination of the Agreement

  	
  79

  
	
   

  	
  13.4

  	
  Other Remedies

  	
  80

  
	
   

  	
  13.5

  	
  Rights in
  Bankruptcy

  	
  81

  
	
   

  	
  13.6

  	
  Survival

  	
  81

  
	
  ARTICLE 14

  	
  DISPUTE
  RESOLUTION

  	
  81

  
	
   

  	
  14.1

  	
  English
  Language; Governing Law

  	
  81

  
	
   

  	
  14.2

  	
  Disputes

  	
  82

  
	
   

  	
  14.3

  	
  Patent and
  Trademark Dispute Resolution

  	
  83

  
	
  ARTICLE 15

  	
  MISCELLANEOUS

  	
  83

  
	
   

  	
  15.1

  	
  Entire
  Agreement; Amendment

  	
  83

  
	
   

  	
  15.2

  	
  Force Majeure

  	
  84

  
	
   

  	
  15.3

  	
  Notices

  	
  84

  
	
   

  	
  15.4

  	
  No Strict
  Construction; Headings

  	
  85

  
	
   

  	
  15.5

  	
  Assignment

  	
  85

  
	
   

  	
  15.6

  	
  Performance by
  Affiliates

  	
  86

  
	
   

  	
  15.7

  	
  Further Actions

  	
  86

  
	
   

  	
  15.8

  	
  Severability

  	
  86

  
	
   

  	
  15.9

  	
  No Waiver

  	
  86

  
	
   

  	
  15.10

  	
  Independent
  Contractors

  	
  87

  



 






[ * ] = 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 406 of the Securities Act of 1933,
as amended.


 


vii

















 


TABLE OF CONTENTS


(CONTINUED)


 


	
   

  	
   

  	
   

  	
  PAGE

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  15.11

  	
  Counterparts

  	
  87

  



 






[ * ] = 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 406 of the Securities Act of
1933, as amended.


 


viii
















 


ARTICLE 1


 


DEFINITIONS


 


As used in this Agreement, the following initially
capitalized terms, whether used in the singular or plural form, shall have the
meanings set forth in this Article 1. 
The terms in this Agreement with initial letters capitalized, whether
used in the singular or the plural, shall have the meaning set forth below or,
if not listed below, the meaning designated in places throughout this
Agreement.


 


1.1                               “Affiliate” means, with respect to a particular
Party, a person, corporation, partnership, or other entity that controls, is
controlled by or is under common control with such Party.  For the purposes of this definition, the word
“control” (including, with correlative meaning, the terms “controlled by” or “under
the common control with”) means, for the purpose of defining
the Affiliate under this Section 1.1, the actual power, either directly or indirectly
through one or more intermediaries, to direct or cause the direction of the
management and policies of such entity, whether by the ownership of fifty
percent (50%) or more of the voting stock of such entity, or by contract or
otherwise.  Notwithstanding the
foregoing, (i) neither the government of Japan, nor any entity controlled
by the government of Japan, shall be deemed to be an Affiliate of Collaborator,
and (ii) TAP Pharmaceutical Products Inc. shall not be deemed to be an
Affiliate of Collaborator.


 


1.2                               “Affymax House Marks” means the Affymax names and logo as set
forth in Exhibit A.


 


1.3                               “Affymax Know-How” means all Information that is Controlled
by Affymax or its Affiliates during the Term and is necessary or useful for the
Development,
manufacture and/or Commercialization of the Product. 
For clarity, Affymax Know-How excludes the Affymax Patents.


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


2

















 


1.4                               “Affymax Patent” means any Patent, including any Joint
Patent, that (a) is Controlled by Affymax or its Affiliates at any time
during the Term, and (b) claims the Peptide, [ * ],
Hematide, Product or their manufacture
or use or any other
invention that is otherwise necessary or useful for the Development, Finished
Manufacture and/or Commercialization of the Product hereunder. The list of Affymax Patent as
of the Effective Date is attached hereto as Exhibit B, and shall be from
time to time amended during the Term to incorporate the then current Affymax
Patents.


 


1.5                               “Affymax Technology” means the Affymax Patent and Affymax
Know-How.


 


1.6                               “Affymax Territory” means worldwide except Japan, its
territories and possessions.


 


1.7                               “Alternative ESA” means any peptide-based synthetic [ * ] ESA other than Hematide, including any such ESA comprised of (i) the Peptide alone, (ii) some peptide(s) other than the
Peptide, (iii) the Peptide linked to a chemical moiety other than the
Reagent(s) by any means, or (iv) some peptide(s) other than the Peptide linked to any chemical moiety(ies) by any means.


 


1.8                               “Backup Product” means any product(s) Controlled by Affymax or its Affiliates,
the active therapeutic ingredient(s) of which are Alternative ESAs.


 


1.9                               “Bulk Hematide” means the active pharmaceutical
ingredient (API) for Hematide, in bulk form.


 


1.10                        “Claims” has the meaning set forth in Section 11.1.


 


1.11                        “CTA” means an application for clinical
trial authorization filed with a Regulatory Authority in the Licensed Territory to undertake clinical trials of an
investigational new drug, the filing of which is necessary to commence or
conduct clinical testing of a pharmaceutical
product in humans in the Licensed 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 406 of the
Securities Act of 1933, as amended.


 


3

















 


1.12                        “Collaborator Know-How” means all Information that is Controlled
by Collaborator or its Affiliates during the Term under this Agreement and is necessary or useful for the Development, manufacture or
Commercialization of the Product.  For
clarity, Collaboration Know-How excludes Collaborator Patents.


 


1.13                        “Collaborator Patent” means any Patent, including any Joint
Patent, that (a) is Controlled by Collaborator or its Affiliates at any
time during the Term under this Agreement, and (b) claims the Peptide, [ * ], Bulk Hematide and/or Product or any method or composition, or
the manufacture or use, of the Peptide, [ * ], Bulk Hematide and/or Product.


 


1.14                        “Collaborator Technology”
means the
Collaborator Patents and Collaborator Know-How.


 


1.15                        “Commercialization”, with a correlative meaning for “Commercialize”, means all activities
undertaken before and after obtaining Regulatory Approval relating specifically
to the pre-launch, launch, promotion, marketing, sale, and distribution of  a pharmaceutical product, including: (a) strategic
marketing, sales force detailing, advertising, medical education and liaison,
and market and product support; and (b) any Phase IV  Clinical Trials, and (c) all customer support and Product
distribution, invoicing and sales activities.


 


1.16                        “Confidential
Information”
means, with respect to a Party, all confidential Information of such Party that
is disclosed to the other Party under this Agreement, which may include
specifications, know-how, trade secrets, legal information, technical information,
drawings, models, business information, inventions, discoveries, methods,
procedures, formulae, protocols, techniques, data, and unpublished patent
applications, whether disclosed in oral, written, graphic, or electronic form.  All confidential Information disclosed by
either Party pursuant to the Mutual Confidential Disclosure Agreement between
the Parties dated September 30, 2005 shall be deemed to be such Party’s
Confidential Information disclosed hereunder.


 


1.17                        “Control” means, with respect to any material,
Information, or intellectual property right, that a Party owns or has a license
to such material, Information, or intellectual property right and has the
ability to grant to the other Party access, a license, or a sublicense (as


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


4

















 


applicable) to
such material, Information, or intellectual property right on the terms and
conditions set forth herein without violating the terms of any agreement or
other arrangement with any Third Party existing at the time such Party would be
first required hereunder to grant to the other Party such access, license, or
sublicense.


 


1.18                        “Develop” or “Development”
means all
activities relating to preparing and conducting preclinical testing, toxicology
testing, human clinical studies, regulatory affairs, formulation
development, process
development for Finished Manufacture and associated validation, quality
assurance and quality control activities. 
Development shall exclude all Phase IV Clinical Trials.


 


1.19                        “Development Plan” means the plan for conducting
Development of the Product to be Commercialized by Collaborator in the Licensed Territory, as set forth
in Section 3.2.


 


1.20                        “Diligent Efforts” means, with respect to a Party’s
obligation under this Agreement to Develop or Commercialize a Product, the
level of efforts required to carry out such obligation in a sustained manner
consistent with the efforts a similarly situated biopharmaceutical company (in
the case of Affymax) or pharmaceutical company (in the case of Collaborator) devotes
to a product of similar market potential, profit potential or strategic
value  within its portfolio, based on
conditions then prevailing.  Diligent
Efforts requires, with respect to such an obligation, that the Party:  (a) promptly assign responsibility for
such obligation to specific employee(s) who are held accountable for
progress and monitor such progress on an on-going basis, (b) set and
consistently seek to achieve specific, meaningful and measurable objectives for
carrying out such obligation, and (c) consistently make and implement
decisions and allocate resources designed to advance progress with respect to
such objectives.


 


1.21                        “[ * ]” means Affymax’s proprietary ESA peptide [ * ]  [ * ] with the
chemical structure attached hereto as Exhibit C.


 


1.22                        “Dollar” means a U.S. dollar, and “$” shall be
interpreted accordingly.


 


1.23                        “EMEA” means the European Agency for the
Evaluation of Medicinal Products, or any successor thereto, which is
responsible for coordinating the centralized system for


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


5

















 


Regulatory
Approval of pharmaceutical products in the European Union and the European
Economic Area and recommending to the European Commission (the “EC”) that the EC grant Regulatory Approval
of certain pharmaceutical products in the EU and EEA under such centralized
system.


 


1.24                        “ESA” means erythropoiesis stimulating agent.


 


1.25                        “FDA” means the U.S. Food and Drug
Administration or its successor.


 


1.26                        “FD&C Act” means the U.S. Federal Food, Drug and
Cosmetic Act, as amended.


 


1.27                        “Field” means the prevention, treatment or
amelioration of anemia in humans, including the Renal Indications and the
Oncology Indications.


 


1.28                        “Finished Manufacture” means the manufacture of Finished Product
from Bulk Hematide.


 


1.29                        “Finished Product” means the Product containing
Hematide that has
been filled into vials, syringes or manufactured into other pharmaceutical
presentations, finished and labeled for use in clinical trials or for
commercial purposes in accordance with the applicable specifications and legal
requirements.


 


1.30                        “First Commercial Sale” means the first sale to a Third Party of
a Product in the Licensed Territory after Regulatory Approval has been obtained in the Licensed Territory.


 


1.31                        “Formulation
Technology” means any technology useful to facilitate delivery of
therapeutic compounds, or that is useful to optimize the absorption or
distribution of therapeutic compounds in the body, but that is not itself a
therapeutic compound; provided that Formulation Technology shall exclude any
technology that comprises a chemical modification of the Peptide, [ * ] or
Hematide.


 


1.32                        “Good Clinical Practices” or “GCP” means the then-current good clinical
practice standards,
practices and procedures promulgated or endorsed by the 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 406 of
the Securities Act of 1933, as amended.


 


6

















 


Authority in the Licensed Territory as set forth in the guidelines including related
regulatory requirements imposed by such Regulatory Authority, as they may be updated from time to
time.


 


1.33                        “Good Laboratory Practices”
or “GLP” means
the then-current good laboratory practice standards promulgated or endorsed by
the Regulatory Authority in the Licensed Territory, as they may be updated from time to time.


 


1.34                        “Good Manufacturing
Practices” or “GMP” means
the then-current good manufacturing practices required by the Regulatory
Authority in the Licensed Territory or, solely for purposes of Affymax’s
obligations under Sections 1.45 and 10.2(d), by the FDA and by the guideline
promulgated by the International Conference on Harmonization designated ICH Q7A,
entitled “Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical
Ingredients” and the
regulations promulgated thereunder, at least until and unless
otherwise agreed by the Parties in the quality agreement entered into pursuant
to Section 7.8,
for the manufacture and testing of pharmaceutical materials, as they may be
updated from time to time.


 


1.35                        “Governmental Authority” means any multi-national, federal,
state, local, municipal or other government authority of any nature (including
any governmental division, subdivision, department, agency, bureau, branch,
office, commission, council, court or other tribunal).


 


1.36                        “Hematide” means Affymax’s proprietary pegylated
ESA drug candidate referred to internally as [ * ],
consisting of the [ * ] attached to the Reagent.


 


1.37                        “IND” means (a) an Investigational New
Drug Application as defined in the applicable regulations promulgated by the Regulatory
Authority in the Licensed Territory, the filing of which is necessary to commence or
conduct clinical testing of a pharmaceutical
product in humans in the Licensed Territory.


 


1.38                        “Information” means any data, results, technology,
business information, and information of any type whatsoever, in any tangible
or intangible form, including, without limitation, know-how, trade secrets,
practices, techniques, methods, processes, inventions, developments,
specifications, formulations, formulae, materials or compositions of matter of
any


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


7

















 


type or kind
(patentable or otherwise), software, algorithms, marketing reports, expertise,
technology, test data (including pharmacological, biological, chemical,
biochemical, toxicological, preclinical and clinical test data), analytical and
quality control data, stability data, other study data and procedures.


 


1.39                        “Initial Indications” means the Renal Indications and/or the Oncology Indications.


 


1.40                        “Joint Committee” means the committee formed by the Parties
as described in Section 2.1(a).


 


1.41                        “Joint Inventions” has the meaning set forth in Section 9.1.


 


1.42                        “Joint Patent” has the meaning set forth in Section 9.3(c).


 


1.43                        “Laws” means all relevant laws, statutes, rules, regulations, guidelines, ordinances and other pronouncements
having the effect of law of any federal, national, multinational, state,
provincial, county, city or other political subdivision, domestic or foreign.


 


1.44                        “Licensed Territory” means Japan, including its territories
and possessions.


 


1.45                        “Manufacturing Costs” (“MC”) means:


 


(a)                                  With respect to Bulk Hematide supplied to
Affymax by its Third Party contract manufacturer(s), Manufacturing Costs shall
mean the sum of (i) all amounts of all payments that Affymax makes to such
Third Party contract manufacturer(s) for supply and delivery to
Collaborator (either directly, or first to Affymax for subsequent delivery to
Collaborator) of such Bulk Hematide, plus all
payments made to third party contractors for release and batch stability
testing services for Bulk Hematide, and (ii) any Overhead Costs
incurred in, and reasonably allocable to, the procurement of Bulk Hematide
supplied to Affymax and supplied to Collaborator.  As used herein “Overhead Costs” means direct
and indirect logistics, quality control, quality assurance, support and
management costs incurred in support of the Third Party contract manufacturer by Affymax and shall be
subject to the reasonable


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


8

















 


approval of
Collaborator.  Further, such methodology
shall be consistent with U.S. Generally Accepted Accounting Principles and
Affymax’s methodology for other products and shall be consistent from
year-to-year ; and


 


(b)                                  With respect to Bulk Hematide
manufactured by Affymax and supplied to Collaborator , if any, Manufacturing
Costs shall mean Direct Expenses, Indirect Expenses and Overhead Costs incurred
in, and reasonably allocable to, the manufacture of such Bulk Hematide.   As used herein:


 


(i)                                    “Direct Expenses” are those
material and labor and services expenses captured in time sheets, invoices, and
the like which are specifically attributable to manufacture of the Bulk
Hematide supplied to Collaborator, including costs of raw materials,
manufacturing supplies, solvents, containers, container components, packaging,
labels and other printed materials used in production.  Direct labor expenses include salaries and
fringe benefits for personnel directly involved in manufacturing Bulk Hematide
in accordance with cGMP requirements such as production, quality control,
quality assurance, microbiology, and other similar departments as needed who
participate directly in the production of Bulk Hematide and components
thereof.  Direct services expenses
include reasonable out of pocket payments to Third Parties for services related
to the manufacture of Bulk Hematide or components thereof.


 


(ii)                                “Indirect Expenses” include
production indirect costs such
as a reasonable allocation of expenses associated with Affymax personnel
supporting the direct manufacturing of Bulk Hematide in accordance with cGMP
requirements.  Indirect Expenses can
include labor for and indirect costs of quality control, quality assurance, raw
material acquisition and acceptance, microbiology, document control,
calibration/validation, and non-R&D expenses for process development and
analytical methods development, and shall not include any
Direct Expenses.


 


(iii)                            “Overhead Costs” are direct and
indirect manufacturing costs that cannot be identified in a practical manner
with specific units of production and, therefore, cannot be included in MC as Direct Expenses
or Indirect Expenses. The
methodology to be used in making the allocations for Overhead Costs shall be
proposed by Affymax and shall be subject to


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


9

















 


the reasonable
approval of Collaborator. Further such methodology shall be consistent with U.S. Generally Accepted
Accounting Principles and Affymax’s methodology for other products and shall be consistent from
year-to-year.


 


For avoidance of doubt, any given cost included in
Manufacturing Costs shall not be included more than once in any calculation
described herein.


 


1.46                        “Marketing Authorization
Application” or “MAA” means an application for Regulatory Approval (but excluding Pricing
Approval) in the Licensed Territory.


 


1.47                        “MHLW” means the Ministry of Health, Labor and Welfare, otherwise referred to as “Korosho” or any successor thereto, which govern the scientific review of human
pharmaceutical products in Japan.


 


1.48                        “Net Sales” means, with respect to a particular time
period, the total amounts billed by Collaborator, its Affiliates and their
respective sublicensees for sales of Finished Products made during such time
period to unaffiliated Third Parties, less the following deductions to the
extent actually allowed or incurred with respect to such sales:


 


(a)                                  discounts, including cash and quantity
discounts, charge-back payments, and rebates actually granted to trade
customers, managed health care organizations, federal, state, or local
government and the agencies, purchasers and reimbursers of managed health
organizations or federal, state or local government, including without
limitation, any
reasonable inventory compensation due to Yakka revision, and  contribution for Drug Induced Suffering and
Contribution for Measure for Drug Safety (as required by Law or applicable
Regulatory Authorities), in the amount determined by the Pharmaceuticals and
Medical Devices Agency (so-called “KIKO”) in Japan, with the aggregate of such
discounts not to exceed [ * ] of the
amounts billed; provided, however, that if such limit is not sufficient or
appropriate for adequately maintaining the competitive position of Products in
the Licensed Territory, the Parties shall confer in good faith regarding
whether any increase in such limit is appropriate under the circumstances;


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


10

















 


(b)                                  credits or allowances actually granted
upon claims, damaged goods, rejections or returns of such Finished Products,
including in connection with recalls;


 


(c)                                  freight, postage, shipping,
transportation and insurance charges actually allowed or paid for delivery of
Finished Products, to the extent billed; and


 


(d)                                  taxes (other than income taxes), duties,
tariffs or other governmental charges levied on the sale of such Products,
including, without limitation, value-added taxes, net of all reimbursements and
allowances.


 


Notwithstanding the
foregoing, amounts billed by Collaborator, its Affiliates, or their respective
sublicensees for the sale of Finished Products among Collaborator, its
Affiliates or their respective sublicensees for resale shall not be included in
the computation of Net Sales hereunder. 
Net Sales shall be accounted for in accordance with generally accepted
accounting principles as practiced internationally, consistently applied. Net
Sales shall exclude any samples of Product transferred or disposed of at no
cost for promotional or educational purposes.


 


Further, the Parties agree to negotiate in good
faith for an equitable determination of the Net Sales of the Product in the
event Collaborator sells the Product in such a manner that gross sales of the
Product are not readily identifiable (e.g., for Products to be sold as a
combination product or bundling with other products.)


 


1.49                        “Oncology Indications” means use of the Product for the
prevention, treatment or amelioration of anemia in patients with cancer.


 


1.50                        “Patents” means (a) pending patent
applications, including provisional patents, issued patents, utility models and
designs; and (b) extensions, reissues, substitutions, confirmations, registrations,
validations, re-examinations, additions, continuations, continued prosecution
applications, requests for continued examination, continuations-in-part, or divisions of or
to any patents, patent applications, utility models or designs.


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


11
















 


1.51                        “Patent Term Extension” means any term extensions, supplementary
protection certificates and equivalents thereof offering patent protection
beyond the initial term with respect to any issued patents.


 


1.52                        “Peptide” means that certain peptide ESA known as [ * ], the chemical structure of which is attached hereto as
Exhibit D.


 


1.53                        “Phase I Clinical Trial”
means a small
scale trial of a pharmaceutical product on subjects that generally provides for
the first introduction into humans of such product with the primary purpose of
determining safety, metabolism and pharmacokinetic properties and clinical
pharmacology of such product.


 


1.54                        “Phase II Clinical Trial”
means a small
scale clinical trial of a pharmaceutical product on patients, including possibly
pharmacokinetic studies, the principal purposes of which are to make a
preliminary determination that such product is safe for its intended use and to
obtain sufficient information about such product’s efficacy to permit the
design of further clinical trials.


 


1.55                        “Phase III Clinical
Trial” means one
or more clinical trials on sufficient numbers of patients, which trial(s) are
designed to (a) establish that a drug is safe and efficacious for its
intended use; (b) define warnings, precautions and adverse reactions that
are associated with the drug in the dosage range to be prescribed; and (c) support
Regulatory Approval of such drug.


 


1.56                        “Phase IIIB Clinical
Trial” means a
Phase III Clinical Trial, possibly including pharmacokinetic studies, commenced
prior to receipt of Regulatory Approval in the jurisdiction for which such
trials are being conducted, but which is not required in order to obtain
Regulatory Approval and which is conducted primarily for the purpose of Product
support (e.g., providing additional drug profile and safety data or supporting
expansion of the Product Labeling).


 


1.57                        “Phase IV Clinical Trial” means a clinical trial of a Product
conducted after Regulatory Approval of such Product has been obtained from an
appropriate Regulatory Authority, which trial is (a) conducted voluntarily
by a Party to enhance marketing or scientific


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


12

















 


knowledge of the Product
(e.g., for expansion of Product Labeling and dose optimization), or (b) conducted
due to a request or requirement of a Regulatory Authority.


 


1.58                        “Pricing Approval” means such approval, agreement,
determination or governmental decision establishing prices (i.e., Yakka) for the Product that can be charged to
consumers and will be reimbursed by Governmental Authorities in the Licensed
Territory.


 


1.59                        “Product” means a pharmaceutical preparation in any
formulation that
contains Hematide as an active ingredient.


 


1.60                        “Product Complaint” means any written, verbal or electronic
expression of dissatisfaction regarding the Product, including without
limitation reports of actual or suspected product tampering, contamination,
mislabeling or inclusion of improper ingredients.


 


1.61                        “Product Infringement” has the meaning set forth in Section 9.5(b).


 


1.62                        “Product Labeling” means (a) the full prescribing
information for the Product approved by the applicable Regulatory Authority,
and (b) all labels and other written, printed or graphic information
included in or placed upon any container, wrapper or package insert used with
or for the Product.


 


1.63                        “Promotional Materials” means all sales representative training
materials and all written, printed, graphic, electronic, audio or video
presentations of information, including, without limitation, journal
advertisements, sales visual aids, formulary binders, reprints, direct mail,
direct-to-consumer advertising, internet postings, broadcast advertisements and
sales reminder aides (for example, note pads, pens and other such items)
intended for use or used by Collaborator or its Affiliates, sublicensees or
licensees in connection with any promotion of a Product in the Licensed
Territory (all to the extent applicable for the Commercialization in the Licensed
Territory), but
excluding Product Labeling.


 


1.64                        “Reagent” means the reagent described in Exhibit E.


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


13

















 


1.65                        “Regulatory Approvals” means all approvals (including without
limitation supplements, amendments, and Price Approvals), licenses,
registrations or authorizations of any national, supra-national, regional,
state or local regulatory agency, department, bureau, commission, council or
other governmental entity, necessary for the manufacture, distribution, use or
sale of a pharmaceutical product in the Licensed Territory.


 


1.66                        “Regulatory Authority” means, in a particular country or
jurisdiction, any applicable Governmental Authority involved in granting
Regulatory Approval in such country or jurisdiction, including without
limitation, (a) in the U.S., the FDA and any other applicable Governmental
Authority in the U.S. having jurisdiction over the Product, and (b) the
MHLW.


 


1.67                        “Regulatory Exclusivity” means any exclusive marketing rights or
data exclusivity rights conferred by any Governmental Authority with respect to
the Product other than a patent right in the Licensed Territory.


 


1.68                        “Regulatory Materials” means regulatory applications,
submissions, notifications, registrations, Regulatory Approvals and/or other
filings made to or with a Regulatory Authority that are necessary or reasonably
desirable in order to develop, manufacture, market, sell or otherwise
commercialize Products in a particular country, territory or possession.  Regulatory Materials include, without
limitation, INDs, CTAs, MAAs, and applications for Pricing Approvals.


 


1.69                        “Renal Indications” means the use of the Product in the
prevention, treatment or amelioration of anemia in patients with chronic kidney
disease, whether or not on dialysis.


 


1.70                        “Required Third Party
Data” has the
meaning set forth in Section 4.1(b).


 


1.71                        “Sole Inventions” has the meaning set forth in Section 9.1.


 


1.72                        “Stock Purchase
Agreement” shall
mean that certain Stock Purchase Agreement to be entered into by and between
Collaborator and Affymax pursuant to Section 8.1(b), for the purchase by
Collaborator of Preferred Stock of 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 406 of
the Securities Act of 1933, as amended.


 


14

















 


1.73                        “Term” means the term of this Agreement, as
determined in accordance with Article 13.


 


1.74                        “Territory” means the Affymax Territory or the
Licensed Territory, as applicable.


 


1.75                        “Third
Indication” means indications other than the Initial Indications.


 


1.76                        “Third Party” means any entity other than Affymax or
Collaborator or an Affiliate of either of them.


 


1.77                        “Third Party Data” has the meaning set forth in Section 4.1(a)(iv).


 


1.78                        “Third Party License
Agreements” has
the meaning set forth in Section 6.7.


 


1.79                        “Third Party Partner” shall have the definition ascribed
thereto in Section 4.1(a)(iv).


 


1.80                        “U.S.” means the United States of America and
its possessions and territories.


 


1.81                        “Valid Claim” means (a) an unexpired claim of an
issued Patent that has not been disclaimed, revoked or held to be invalid or
unenforceable by a court or other authority of competent jurisdiction, from
which decision no appeal can be further taken; or (b) a claim of a pending
Patent application.


 


1.82                        “Yakka” means the approval by the MHLW of the
National Health Insurance System (NHI) reimbursable price for the Product in
the Licensed Territory.


 


1.83                        “Yen” means a Japanese unit of currency, and “¥”
shall be interpreted accordingly.


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


15

















 


ARTICLE 2


 


MANAGEMENT


 


2.1                               Joint Committee.


 


(a)                                  Formation and Role. 
The Parties hereby establish a Joint Committee that shall monitor and
coordinate communication regarding the Parties’ performance under this Agreement to Develop and obtain Regulatory Approval for the Product in the Field and in the Licensed
Territory.  Each Party shall have an
equal number of representatives on the Joint Committee, who initially shall be
the individuals set forth in Exhibit F. 
The Joint Committee shall have the membership and authority, and shall
operate by the procedures, set forth for it in this Section 2.1 and in Section 2.2.  The role of the Joint Committee shall be:


 


(i)                                    to review the overall strategy for
seeking Regulatory Approval in the Licensed Territory of the Product for the
Initial Indications and any other indications in the Field Collaborator seeks
to develop the Product for;


 


(ii)                                to facilitate the exchange of information
between the Parties with respect to the activities hereunder for the Licensed
Territory and to establish procedures for the efficient sharing of information
and materials necessary for Collaborator’s Development of Products hereunder,
consistent with this Agreement;


 


(iii)                            to review, approve, and, if necessary,
amend the Development Plan;


 


(iv)                               to seek to resolve any issues arising
under this Agreement;


 


(v)                                   to monitor the Parties’ performance against each then-current
Development Plan;


 


(vi)                               to provide a forum to evaluate strategies
for obtaining, maintaining and enforcing patent and trademark protection for
Products in the Licensed Territory; and


 


(vii)                           to perform such other functions as
appropriate to further the purposes of this Agreement, as determined by the
Parties.


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


16

















 


The Joint Committee shall perform its responsibilities
under this Agreement based on the principles of prompt and diligent Development
of Products in the Licensed Territory, consistent with good pharmaceutical
practices and the maximization of long-term profits derived from the sale of
Products in the Licensed Territory.  The
Joint Committee shall have only the powers assigned expressly to it in this Article 2
and elsewhere in this Agreement, and the Joint Committee shall not have any
power to amend, modify or waive compliance with this Agreement.


 


2.2                               Joint Committee Membership


 


Affymax and Collaborator shall each designate three (3) representatives
to serve on the Joint Committee by written notices to the other Party.  Either Party may designate substitutes for
its representatives if one (1) or more of such Party’s designated
representatives are unable to be present at a meeting.  From time to time each Party may replace its
representatives by written notice to the other Party specifying the prior
representative(s) and their replacement(s).  Any such substitutes or replacements shall be
designated consistent with the following principles:  one (1) representative shall have
appropriate expertise in the clinical Development of pharmaceutical products, and one (1) representative
shall have appropriate expertise in Commercialization of pharmaceutical
products; provided that the Joint
Committee may vary the expertise required for Joint Committee representatives of
each Party as it deems appropriate as the Parties gain experience with
Products, but in any event at least one (1) of such representatives on the
Joint Committee shall be at the [ * ] in each
of the Party’s organizations. 
Collaborator shall select one (1) of its representatives as the
initial chairperson of the Joint Committee. 
On each anniversary of the Effective Date, the Parties shall rotate
designation of the chairperson for the commencing year.  The chairperson shall be responsible for (i) calling
meetings, and (ii) preparing and circulating an agenda for the upcoming
meeting pursuant to Section 2.3(b), but shall have no special authority
over the other members of the Joint Committee, and shall have no additional
voting rights.  One of Collaborator’s
Joint Committee representatives shall be responsible for preparing and issuing
minutes of each such meeting within thirty (30) days thereafter.  Such minutes shall not be finalized until
Affymax reviews and


 






[ * ] = 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 406 of the
Securities Act of 1933, as amended.


 


17

















 


confirms with Collaborator the accuracy of such minutes in writing, which review by
Affymax shall be completed within thirty (30) days after the receipt of the
minutes.


 


2.3                               Joint Committee Meetings and
Agendas.


 


(a)                                  Meetings. The Joint Committee shall hold at least two
(2) meetings per year on such dates at such times each year as it
elects.  Meetings of the Joint Committee
shall be effective only if at least [ * ]
representatives of each Party are present or participating.  The
Joint Committee may meet either (i) in person at either Party’s facilities
or at such locations as the Parties may otherwise agree; or (ii) by audio
or video teleconference.  With the prior
consent of each Party’s representatives, other representatives of each Party or
Third Parties involved with the Products may attend meetings as nonvoting
participants.  Additional meetings of the
Joint Committee may also be held with the consent of each Party, or as required
under this Agreement, and neither Party shall unreasonably withhold or delay
its consent to hold such an additional meeting. 
Each Party shall be responsible for all of its own expenses incurred in
connection with participating in the Joint Committee.


 


(b)                                  Meeting Agendas. 
The chairperson of the Joint Committee shall prepare a draft agenda
containing the topics (i.e., Development and/or manufacturing issues) for the upcoming
meeting.  The chairperson shall disclose
to the other members of the Joint Committee (i) the draft agenda no later
than ten (10) business days in advance, and (ii) its final agenda
(along with appropriate related Information) at least five (5) business
days in advance, of each meeting of the Joint Committee; provided that under exigent circumstances
requiring Joint Committee input, the chairperson may provide the draft and
final agenda to the other members of the Joint Committee with a lesser period
of time in advance of the meeting, or may propose that there not be a specific
agenda for a particular meeting, so long as such other Joint Committee members
consent to such temporary changes to the general process for distributing the
agenda for Joint Committee meetings.


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


18

















 


2.4                               Joint Committee Decisions and
Actions.


 


(a)                                  Decision Making. 
Except as expressly provided in this Section 2.4, actions to be
taken by the Joint Committee shall be taken only following unanimous vote, with
each Party having one (1) vote.  If
the Joint Committee fails to reach unanimous agreement on a matter before it
for decision for a period in excess of ten (10) business days from the discussion at the
Joint Committee and unless the Parties agree to prolong such time period, the matter shall be referred to the
senior executive officers of the Parties pursuant to Section 14.2, except
as otherwise provided in Section 2.4(b) or 2.4(c).


 


(b)                                  Dispute.  If the members of the Joint Committee cannot reach a unanimous
decision with respect to matters involving the [ * ],
[ * ] or the approval of any component
of an amended or updated Development Plan (a “Dispute”)
within the time period set forth in above subsection (a), such matter shall not be referred to
the senior executive officers of the Parties; rather, the final decision on
such Dispute shall be made by Collaborator, as and to the extent set forth in
this subsection 2.4(b), except if such matter is an Excepted Development
Matter.


 


(c)                                  Excepted Development Matters.  For the purpose of this Section 2.4, “Excepted Development Matters” means
the following:


 


(i)                                    altering the [ * ]
to provide for the Development of  [ * ]
other than the [ * ]; and


 


(ii)                                [ * ] for the Product  [ * ] in
accordance with its protocol, as a consequence of [ * ]
that are likely to affect the [ * ] the
Product or [ * ] affect the [ * ] for such Product [ * ], 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;


 


(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 in the [ * ], 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.


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


19

















 


If a matter in dispute is an Excepted Development Matter, such matter
shall be referred to the senior executive officers of the Parties pursuant to Section 2.4(a),
and where such senior executive officers cannot resolve any such Excepted
Development Matter referred to them, then the status quo shall prevail (i.e.,
Collaborator shall not have the right to have such alteration or amendment
implemented or a [ * ] shall not be [ * ]), and Collaborator shall proceed with Development
under the then-existing Development Plan, provided, however, in case
of subsection (iii) above, Collaborator shall not have the right to so
alter the [ * ] or conduct such Development
activities.


 


2.5                               Project Coordinators. 
Promptly following the Effective Date, each Party shall designate on Exhibit F
an appropriate expert to facilitate communication and coordination of the
Parties’ activities under this Agreement relating to Products and to provide
support and guidance to the Joint Committee (each, a “Project Coordinator”).  Each Project Coordinator shall be experienced
in project management and may also serve as one of the three (3) representatives
of its respective Party on the Joint Committee.  From time to time each Party may replace its Project
Coordinator by
written notice to the other Party specifying the replacement.


 


2.6                               Collaboration Guidelines. 
In all matters relating to this Agreement, each Party shall seek to
comply with good pharmaceutical and environmental practices consistent with the Laws and its own existing practices.  Subject to the terms of this Agreement, the
activities and resources of each Party shall be managed by such Party, acting
independently and in its individual capacity. 
The relationship between Affymax and Collaborator is that of independent
contractors and neither Party shall have the power to bind or obligate the
other Party in any manner, other than as expressly set forth in this Agreement.


 


ARTICLE 3


 


PRODUCT DEVELOPMENT


 


3.1                               Overview. 
Collaborator shall Develop Products in the Licensed Territory as
provided in this Article 3 and in accordance with the Development Plan,
which shall set forth all Development activities to be performed by
Collaborator under this Agreement, including without


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


20

















 


limitation such
activities as may be required by the Regulatory Authorities in the Licensed
Territory for Regulatory Approval of Products for use in the Initial
Indications in the Licensed Territory, and any additional activities necessary
for any Product to meet the requirements of the Japanese Pharmacopoeia or any
other listings that are necessary or helpful for obtaining Price Approval for
such Product in the Initial Indications in the Licensed Territory (such additional activities,
“Required Studies”). Affymax shall
complete all [ * ] regarding the Product that
are listed on Exhibit G, at its own cost, risk and responsibility and
shall provide Collaborator the data obtained therein as provided in Section 4.1(a). 
Collaborator shall bear all of the costs and expenses incurred in
connection with any of the activities performed by the Collaborator pursuant to the Development Plan.


 


3.2                               Development Plan. 
An initial Development
Plan has been agreed upon by the Parties and is attached hereto as Exhibit H
and incorporated herein by reference. 
From time to time, either Party may submit to the Joint Committee for
discussion any proposed modifications to the Development Plan, and the Joint
Committee shall discuss such proposed modifications at its next meeting, and
any such modification may be approved by the Joint Committee as provided in Section 2.4.  The Development Plan shall, at all times,
contain the following information for the Product for both of the Initial
Indications in the Licensed Territory:


 


(a)                                  scope and timelines for Collaborator’s
performance of all studies (including any Required Studies) designed to support
Regulatory Approval of the Product in the Licensed Territory, including without
limitation, clinical trial protocols, additional preclinical tests (including
any and all carcinogenicity and toxicology studies), Finished Product stability
studies, enrollment numbers and filing submission dates;


 


(b)                                  estimated dates of meetings with
Regulatory Authorities in the Licensed Territory for such Product;


 


(c)                                  Collaborator’s forecasts of its needs for
preclinical or clinical supply of such Product and/or Bulk Hematide; and


 


(d)                                  target dates for achieving milestones in
Developing such Product.


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


21
















 


3.3                               Principles of Product
Development.  Collaborator’s Development of the Product
in the Initial Indications in the Licensed Territory shall be conducted in a
manner consistent with the following principles:


 


(a)                                  using Diligent
Efforts to seek a
Regulatory Approval that includes a label for such Product as broad as
reasonably possible;


 


(b)                                  using Diligent
Efforts to seek a
product profile for such Product with maximum scope of recommended usage and
minimum scope of restrictions on use, in each case to the extent
reasonably possible;


 


(c)                                  using Diligent
Efforts to obtain
Regulatory Approval for such Product consistent with (a) and (b) in a
timely manner; and


 


(d)                                  using Diligent
Efforts not to unreasonably adversely impact Affymax’s or its Third
Party Partner’s own Development or Commercialization efforts for Products in
the Affymax Territory, 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 pursuant to Section 4.2,
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 in
the Affymax Territory.


 


3.4                               Collaborator’s
Performance.  Collaborator shall devote Diligent Efforts to
the Development of the Product in the Field and in the Licensed Territory,
consistent with the then-agreed Development Plan, and in accordance with this
Agreement, including without limitation by using Diligent Efforts to perform
its obligations under the Development Plan and in accordance with the
regulations promulgated by the MHLW for the manufacture, testing and Commercialization of pharmaceutical products
in the Licensed Territory.  Collaborator shall provide
financial and other support for the Development of the Product as necessary to
carry out the Development Plan and to achieve the objectives of this Agreement.  Collaborator shall conduct its activities
under the Development Plan in good scientific manner and in compliance in all
material respects with all applicable Laws, including without limitation
applicable GCP, GLP,


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


22

















 


and GMP.  Collaborator may not conduct any material
Development activities with respect to any Product that are not set forth in
the Development Plan or that are inconsistent with this Agreement without
Affymax’s prior written consent.


 


3.5                               Records, Reports and
Information.  Collaborator
shall maintain complete, current and accurate records of all work conducted by
it under the Development Plan and all data and other Information resulting from
such work.  Such records shall fully and
properly reflect all work done and results achieved in the performance of the
Development Plan in sufficient detail and in good scientific manner appropriate
for patent and regulatory purposes. 
Affymax shall have the right to review such records maintained by
Collaborator at reasonable times, upon written request.  Collaborator shall provide written reports in
English to the Joint Committee on its Development and regulatory activities
with Products in the Licensed Territory, including without limitation any
significant formal or informal meetings between Collaborator and the Regulatory
Authority in the Licensed Territory, on a quarterly basis at the end of each calendar
quarter, at a level of detail reasonably sufficient to enable Affymax to
determine Collaborator’s compliance with its diligence obligation pursuant to Section 3.4.


 


3.6                               Right of First Refusal
to Backup Product Developed in the Field. 
If, during the ten (10) year
period following the Effective Date, Affymax or its Third Party Partner 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.  Upon the
initiation of the first Phase II Clinical Trial for such Backup Product(s) in the
Field, and before offering
to any Third Party rights to such potential Backup Product(s) in the Licensed Territory, Affymax shall
notify Collaborator in writing, and shall include in such notification all
material results and data with respect to such potential Backup Product(s), for Collaborator’s evaluation.
Collaborator shall treat such results and data as Affymax’s Confidential
Information under this Agreement, and shall respond to Affymax within thirty
(30) days of receiving such notification whether it desires to exercise its
right to negotiate exclusively for the rights to Develop and Commercialize such
Backup Product(s) in the Field, in the Licensed Territory.  If Collaborator notifies Affymax within such
thirty (30) day period of its desire to obtain such rights, then Affymax and
Collaborator shall negotiate in good faith for


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


23

















 


ninety (90) days the
terms and conditions under which Collaborator may obtain such rights.   If
Collaborator and Affymax enter into an agreement under which Collaborator
obtains such rights with respect to certain Backup Product, then such Backup
Product(s) shall also be licensed to Collaborator under such agreed terms and
conditions.  If Collaborator fails to notify Affymax of
its desire to obtain such rights within such thirty (30) day period, or if the
Parties, despite good faith negotiation, do not enter into an agreement
governing the terms and conditions under which Collaborator may obtain such
rights from Affymax within such ninety (90) day period, then,  unless the Parties agree to
prolong such period, Affymax
shall have the right to pursue such opportunity itself or with an Affiliate or
Third Party without any further obligation to Collaborator.  
This Section 3.6 shall apply on a Backup Product by Backup Product
basis.  For clarity, if and as far as a Backup Product is developed outside the Field by Affymax and/or its Third
Party Partner, then Collaborator shall have no rights under this Section 3.6 with respect to
such Backup Product.


 


ARTICLE 4


 


REGULATORY MATTERS


 


4.1                               Transfer of Data and Regulatory
Materials.


 


(a)                                  Data Generated by Affymax.


 


(i)                                    Within thirty (30) days after the Effective Date, Affymax shall provide
Collaborator with copies of IND and CTA filings made for the Product in the
U.S. and Europe prior to the Effective Date. 
With regard to all
other preclinical
and non-clinical data (including [ * ]above-mentioned
IND and CTA filings, in the form then existing) generated as of the Effective Date and Controlled by
Affymax, Affymax shall, if requested by Collaborator, provide Collaborator with
copies thereof within a reasonable time after such request to the extent relevant to the Development
of Product or Collaborator’s seeking Regulatory Approval for the Product in the
Licensed Territory.  Thereafter, from time to time but in a
timely manner compliant with the requirements of the Regulatory Authority in
the Licensed Territory, Affymax shall provide Collaborator with copies of [ * ] preclinical and non-clinical data generated from


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


24

















 


[ * ] the Effective Date by Affymax and
Controlled by Affymax.   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 of the Product in the Licensed Territory, including the
incorporation of such data or reports in any MAA.


 


(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, following completion of any additional [ * ]]
conducted by Affymax with or without [ * ], Affymax
shall, in a timely manner compliant with the requirements of the Regulatory
Authority in the Licensed Territory, provide Collaborator with copies of all
resulting data, to the extent such data is Controlled by Affymax. Collaborator
shall have the full right to use any and all such data and reports supplied by
Affymax pursuant to this Section 4.1(a)(ii) in connection with the
Development of the Product in the Licensed Territory, including the
incorporation of such data or reports in any MAA.


 


(iii)                            With respect to clinical data Controlled
by Affymax and resulting from [ * ] completed
or ongoing as of the Effective Date, Affymax shall provide Collaborator with
copies of all resulting data upon request of Collaborator after completion of
such trial.  It is understood and agreed,
however, that Collaborator shall have the right to use any and all such data
and reports supplied by Affymax hereunder only to the extent that the
Regulatory Authorities in the Licensed Territory require that such data and or
reports be submitted to it to substantiate the clinical data generated by or on
behalf of Collaborator in seeking Regulatory Approval for the Product in the
Licensed Territory, either as part of the MAA or otherwise.  In no event shall Collaborator have the right
to utilize such [ * ] data in its MAA for the
Product in the Licensed Territory in lieu of additional [ * ]
data generated by or on behalf of Collaborator in the Licensed Territory,
without the written consent of Affymax, which consent may be withheld in its
sole discretion, and which consent if given, shall require [ * ]
to Affymax for such use of such data.


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


25

















 


(iv)                               Collaborator acknowledges and understands
that Affymax intends to license the Product to one or more Third Party
licensees for development and commercialization in the Affymax Territory (each,
a “Third Party Partner”).  Pursuant to any agreements between Affymax
and its Third Party Partner, Affymax and/or such Third Party Partners will
generate, at the expense primarily of such Third Party Partner, additional
non-clinical, preclinical and clinical data and reports (including in
particular [ * ] and [ * ]
with respect to the Product for use in seeking Regulatory Approval for the
Product in the Affymax Territory (the “Third
Party Data”). With respect to any Third Party Data Controlled by
Affymax [ * ], Affymax shall provide
Collaborator with copies of all such Third Party Data upon request of
Collaborator unless (X) Affymax [ * ] and/or (Y) [ * ] Third Party Partner in connection therewith. For any
Third Party Data to which (X) and/or (Y) applies, Collaborator shall
have the rights set forth in Section 4.1(b)(ii).   It is understood and agreed, however, that
Collaborator shall have the right to use any and all such Third Party Data and
reports supplied by Affymax under this Section 4.1(a)(iv) only to the extent that the Regulatory
Authorities in the Licensed Territory require that such data be submitted to it
to substantiate the non-clinical, preclinical or clinical data generated by or
on behalf of Collaborator in seeking Regulatory Approval for the Product in the
Licensed Territory, either as part of the MAA or otherwise.  In no event shall Collaborator have the right
to utilize such Third Party Data provided pursuant to this Section 4.1(a)(iv) in
its MAA for the Product in the Licensed Territory in lieu of additional
non-clinical, pre-clinical or clinical data generated by or on behalf of
Collaborator in the Licensed Territory, without the written consent of Affymax,
which consent may be withheld in its sole discretion, and which consent if
given, shall require [ * ] for such
use of such data. 
For clarity, this Section 4.1(a)(iv) shall
not apply to any audited data that Affymax may provide to Collaborator pursuant
to Section 4.1(b)(i).


 


(v)                                   With respect to any data generated
pursuant to any [ * ] that is commenced [ * ] by Affymax other than [ * ],
to the extent such data is Controlled by Affymax, Affymax shall provide
Collaborator with copies of all data arising from such trial upon request of
Collaborator, provided that the Parties have first agreed upon a mutually
acceptable [ * ] for


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


26

















 


such use of such data;
provided that information regarding adverse events and serious adverse events
shall be provided promptly as set forth in Section 4.8.


 


(vi)                               For clarity, the foregoing shall not be
deemed to limit the Parties’ obligations with respect to information to be
provided pursuant to Section 4.8. 
Additionally, except as expressly provided in subsections (iii) and
(iv), Collaborator shall not be obligated [ * ] for the
information, data and reports to be provided pursuant to this Section 4.1(a).


 


(b)                                  Audited Data Generated by Third
Parties on Behalf of Affymax; Requests for Additional Data by
Collaborator.


 


(i)                                    Affymax understands and acknowledges
Collaborator’s need to utilize and include copies of certain [ * ]  and certain summary and general information
regarding the [ * ] of the Product that has been audited as required by
applicable Laws and that is contained within the Third Party Data [ * ] in Collaborator’s Japanese Investigator’s Brochure (“JIB”) and as required in its filings for
Regulatory Approvals in the Licensed Territory (the “Required Third Party Data”). 
Affymax agrees to ensure the transfer of copies of such Required Third
Party Data to Collaborator [ * ]
Collaborator so as to enable Collaborator to conduct Development activities and to obtain
Regulatory Approval within
the Licensed Territory.  It is expressly
understood and agreed, however, that such Required Third Party Data shall not
include any [ * ] data resulting from any
clinical studies undertaken by Affymax and its Third Party Partner jointly, or
by such Third Party Partner alone, which data may be provided to Collaborator
as set forth elsewhere in this Agreement, provided that information regarding
adverse events and serious adverse events shall be provided promptly as set
forth in Section 4.8.


 


(ii)                                In addition to Affymax’s obligations set
forth in Sections 4.1(a)(iv) and 4.1(b)(i), to the extent Affymax is
unable to provide access to Collaborator to Third Party Data that is not
Required Third Party Data or data that Affymax is able to provide to
Collaborator pursuant to Section 4.1(a)(iv), if Collaborator so requests, Affymax agrees to use diligent efforts to
negotiate with its Third Party Partners the right to transfer to Collaborator
for its use in the Licensed Territory any such Third Party Data resulting from
Affymax’s collaboration with such Third Party Partners in the Affymax
Territory, subject to Collaborator’s


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


27

















 


[ * ] Affymax [ * ],
[ * ] Affymax in relation thereto and [ * ] Collaborator [ * ] such Third Party Partner [ * ] for the transfer to Collaborator of such data, under
any relevant agreement with respect thereto [ * ]
Third Party Partner.


 


(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, manufacturing, and
clinical data relating to the Product and generated by Collaborator or on
behalf of Collaborator 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. If Affymax requests that copies of such data be provided in
compliance with requirements of other Regulatory Authorities, Collaborator
shall reasonably consider such request.


 


(d)                                  Use of Collaborator
Data.  Collaborator understands and acknowledges that Affymax and
its Affiliates and/or Third
Party Partners may need to utilize and include certain safety data and certain
summary and general information regarding the demonstration of efficacy of the
Product generated by
Collaborator (e.g., adverse event reports, tabulated data summaries) as
required in its filings for Regulatory Approvals in the Affymax Territory or as
requested by the Regulatory Authorities in the Affymax Territory.  Affymax shall have the right to share any and
all such data and other regulatory materials received from Collaborator (“Required Collaborator Data”) with Affymax’s
Affiliates and Third Party licensees in the Affymax Territory. It is expressly understood and agreed,
however, that such Required Collaborator Data shall not include any [ * ] resulting from any clinical studies
undertaken by Collaborator or on behalf of Collaborator by any Third Party, and
that such [ * ] may be provided to
Affymax and/or its Affiliate or Third Party Partner only as provided in the
following sentences of this Section 4.1(d).  Affymax shall have the right to transfer any
and all data and other regulatory materials received from Collaborator pursuant
to Section 4.1(c) that is not otherwise included in Required
Collaborator Data to any of Affymax’s Affiliates or Third Party Partners in the
Affymax Territory, subject to Affymax’s having obtained the right to transfer
to Collaborator for its use in the Licensed Territory the Third Party Data that
is not otherwise included in the Required Third Party Data of its Third Party
Partners, and the equivalent data of such Affiliates,


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


28

















 


and subject to [ * ] as applicable, of a [ * ]
Collaborator [ * ] the transfer to such
Affiliates and Third Party Partners of such data and other regulatory materials
of Collaborator.


 


(e)                                  Clarification.  All preclinical, non-clinical, analytical,
manufacturing, and clinical data and associated reports disclosed by one Party
to the other under this Agreement shall be deemed Confidential Information of
the disclosing Party.   Except as
otherwise provided in this Section 4.1, the receiving Party may use such
data solely for the purpose of Developing a Product, seeking and obtaining
Regulatory Approval and Commercializing the Product as permitted in this
Agreement, in its respective Territory, subject to Article 12.


 


4.2                               Regulatory Filings and Approvals.


 


(a)                                  In General. 
The Parties intend that the Development Plan shall set forth the agreed
regulatory strategy for seeking Regulatory Approval in the Licensed
Territory.  Collaborator shall be
responsible for preparing any and all Regulatory Materials to be used for
filing with Regulatory Authority in the Licensed Territory and for filing CTAs,
INDs or their equivalent in the Licensed Territory, Marketing Authorization
Applications, Pricing Approval applications and all other applications in
connection with seeking Regulatory Approvals for the Products in the Licensed
Territory.  Any efforts, costs and expenses
required for the Collaborator to prepare any and all regulatory submissions for the Products in the Licensed Territory shall be
conducted and borne solely by the Collaborator, provided, however, with
regard to the Chemistry, Manufacturing and Controls (“CMC”) section of such regulatory submissions,
and other part(s) of such submissions, related to the manufacture of the
Bulk Hematide, Affymax shall prepare necessary documents in English and provide
such documents to Collaborator in a timely manner so that Collaborator can
translate (if necessary) and compile such documents in the filing of CTAs, INDs or their equivalent
in the Licensed Territory, Marketing Authorization Applications, Pricing
Approval applications and all other applications in connection with seeking
Regulatory Approvals for the Products in the Licensed Territory.


 


(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  in its respective Territory for Product as follows:  The right of reference granted to Affymax
herein


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


29

















 


shall be solely for the
purpose of Affymax, its Affiliates or any Third Party Partners of Affymax
obtaining Regulatory Approval in the Affymax Territory for the Product.  The right of reference granted to
Collaborator herein shall be solely for the purpose of obtaining Regulatory
Approval for the Products in the Licensed Territory, subject to Section 4.1(a)(iii).


 


(c)                                  Collaborator Rights and
Obligations.


 


(i)                                    Collaborator shall have the sole right
and responsibility for preparing, submitting and maintaining Regulatory
Materials in the Licensed Territory and for seeking Regulatory Approval for the
Product in the Licensed Territory.  As part
of the foregoing, Collaborator shall be responsible for seeking any necessary
approvals of Regulatory Authorities for Product Labeling and Promotional
Materials to be used in the applicable jurisdiction(s) in connection with
Commercializing the Product.  Upon the
request of Affymax, Collaborator shall request the MHLW to allow one Affymax representative to
attend, as a silent observer, all meetings between Collaborator and the MHLW,
and Collaborator shall timely inform Affymax of any such meetings scheduled
with the MHLW as soon as practically possible.


 


(ii)                                Collaborator shall use Diligent Efforts
in compliance with applicable Laws and other regulatory obligations related to
Product Development and Regulatory Approval in the Licensed Territory, to
prepare and file the appropriate Regulatory Materials and to seek to obtain
Regulatory Approval therefor as soon as reasonably practicable.


 


(iii)                            All Regulatory Materials and Regulatory
Approvals filed with Regulatory Authorities in the Licensed Territory shall be
held in Collaborator’s name and shall be owned solely by Collaborator, subject
to Affymax’s rights under this Agreement.


 


(iv)                               Collaborator shall not have the right to
file any Regulatory
Materials or Regulatory Approvals regarding the Product outside of the Licensed Territory.


 


(d)                                  Consultation, Reporting and Review.


 


(i)                                    Collaborator shall consult with Affymax
regarding, and keep Affymax reasonably and regularly informed of, the status of
the preparation of all 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 406 of
the Securities Act of 1933, as amended.


 


30

















 


Materials, Regulatory
Authority review of Regulatory Materials, and Regulatory Approvals for Products
in the Licensed Territory.


 


(ii)                                Collaborator shall provide Affymax, in a
timely manner, with copies of all Regulatory Approvals it receives for Products
in the Licensed Territory, upon Affymax’s written request.


 


(iii)                            Collaborator shall provide Affymax with
copies of, and all information pertaining to, notices, questions, actions and
requests from or by Regulatory Authorities in the Licensed Territory with
respect to Products, the Peptide, [ * ] and/or Hematide, or the testing,
manufacture, distribution and/or facilities in relation thereto, including
without limitation any notices of non-compliance with Laws in connection with
the Product (e.g.,  warning letters or
other notices of alleged non-compliance), audit notices, notices of initiation
by Regulatory Authorities of investigations, inspections, detentions, seizures
or injunctions concerning the Product (and/or its manufacture, distribution,
and/or facilities connected thereto), notice of violation letters (i.e., an
untitled letter), warning letters, service of process or other inquiries.


 


4.3                               Filings for Regulatory
Exclusivity.   The Joint Committee shall discuss and
recommend to Collaborator the regulatory strategy for seeking (if and when
appropriate) Regulatory Exclusivity in the Licensed Territory for
Products.  Collaborator shall seek and
(if appropriate) file for such Regulatory Exclusivity for Products if the Joint
Committee so recommends.


 


4.4                               Regulatory Costs.  Collaborator shall be responsible for all costs and
expenses of preparing, maintaining, formatting, and filing Regulatory Materials
for Products in the Licensed Territory and for all other costs and expenses in
connection with seeking and maintaining Regulatory Approval for Products in the
Licensed Territory.


 


4.5                               Communications. 
Except as may be required by Laws, Affymax shall not communicate regarding the Product
with any Regulatory Authority having jurisdiction in the Licensed Territory
unless explicitly requested or permitted in writing to do so by Collaborator or


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


31

















 


unless so ordered by such
Regulatory Authority in the Licensed Territory, in which case Affymax shall
provide immediately to Collaborator notice of such order.  Except as may be required by law,
Collaborator shall not communicate with any Regulatory Authority having
jurisdiction outside the Licensed Territory regarding any Product unless
explicitly requested or permitted in writing to do so by Affymax, or unless so
ordered by such Regulatory Authority, in which case Collaborator shall provide
immediately to Affymax notice of such order.


 


4.6                               Collaborator Regulatory
Filings.  Collaborator shall not file any IND, CTA or
MAA or their equivalent applications in the Licensed Territory for any Product
for use in an indication that is not an Initial Indication without the prior
written consent of Affymax or unanimous consent of the JC pursuant to Section 2.4(c).  Collaborator shall not file any Regulatory
Materials for Peptide, [ * ], Hematide and/or Product outside of the Licensed
Territory.


 


4.7                               No Harmful Actions. 
Collaborator shall not take any action with respect to Products in the
Licensed Territory that could reasonably be expected to have a material adverse
impact upon the regulatory status or potential sales of Products outside the
Licensed Territory, provided that the foregoing shall not restrict Collaborator
from taking actions reasonably required to avoid or address any safety or human
health problems as required by Regulatory Authorities in the Licensed Territory
or the relevant independent data safety monitoring board.  If Affymax believes that Collaborator is taking or
intends to take any action that could reasonably have such an impact, Affymax
shall bring the matter to the attention of the Joint Committee.  The Joint Committee shall discuss whether any
such action reasonably would be expected to have such an impact, and potential
alternative courses of action that Collaborator could take to avoid such an
impact.  If the Joint Committee cannot
reach agreement as to such matters, then either Party may refer such matters
for resolution pursuant to Sections 14.1 and 14.2.  Furthermore, Collaborator shall use Diligent Efforts to preserve the existence and breadth of any Regulatory Approvals for Products
obtained in the Licensed Territory in the course of reexamination, reevaluation
and other post marketing surveillance review procedures required by Regulatory
Authorities in the Licensed Territory or the relevant independent data safety
monitoring board.


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


32
















 


4.8                               Adverse Event Reporting
and Safety Data Exchange.  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 Affymax or its Third Party Partner(s) shall have primary responsibility for the
monitoring of all clinical experiences and filing of all required reports
concerning the Product in the Affymax Territory.  Specific details regarding the exchange and management of information relating to
adverse events related to the use of the Product shall be delineated in a
separate agreement that shall be agreed to by the Parties within one
hundred eighty (180) days after the Effective Date, but in no event later than
thirty (30) days prior to the first dosing to the first patient in the clinical
trial conducted by Collaborator hereunder in or for the Licensed Territory of
the Product.  The pharmacovigilance and product labeling
personnel of each Party shall work in good faith together during such time to negotiate an agreement that:


 


(a)                                  identifies which safety information shall
be exchanged;


 


(b)                                  identifies when such information shall be
exchanged;


 


(c)                                  provides that Collaborator shall have
regulatory reporting responsibilities in the Licensed Territory, and Affymax
(either itself or through a clinical research organization with which it has
contracted) or its Third Party Partner(s) shall have regulatory reporting responsibilities
in the Affymax Territory;


 


(d)                                  provides that Affymax (or its Third Party
Partner(s)) shall
manage the global safety database;


 


(e)                                  identifies which Party shall be obligated
to obtain follow-up information on incomplete safety reports;


 


(f)                                    identifies which Party shall review the
literature for safety report information;


 


(g)                                 sets forth the roles and responsibilities
of the Parties related to review and approval of safety information for
inclusion in the Product Labeling in the Licensed 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 406 of
the Securities Act of 1933, as amended.


 


33

















 


(h)                                 identifies which Party shall prepare
required periodic safety updates; and


 


(i)                                    identifies any other details required to
appropriately manage safety information for the Product.


 


4.9                               Regulatory Authority Communications
Received by a Party.


 


(a)                                  General.  Each Party shall keep the other Party informed, in a
timely manner compliant with the reporting requirements of (i) if the
other Party is Affymax, the FDA and EMEA, and (ii) if the other Party is
Collaborator, Regulatory Authorities in the Licensed Territory, of notification
of any action by, or notification or other information which the first Party
receives (directly or indirectly) from any such Regulatory Authority in its
territory which:  (1) raises any [ * ] of the Product; (2) indicates or suggests [ * ] in connection with the Product; (3) is reasonably
likely to lead to [ * ] of the
Product; or (4) relates to [ * ] with
respect to the Product, or [ * ], and
which may have [ * ] the Product.  If Affymax requests that copies of
notifications or information received by Collaborator that would be provided
pursuant to the foregoing sentence in compliance with FDA and EMEA requirements
be provided also in compliance with requirements of Regulatory Authorities other
than the FDA or EMEA, Collaborator shall reasonably consider such request.  In addition, if a Party receives any
communication or questions from any Regulatory Authority in the other Party’s
territory relating to such matters, such Party shall notify the other Party as
soon as possible (but in no event later than two (2) business days after
receipt of such notice or inquiry) and provide to such other Party copies of
all documents, if any, it received from such Regulatory Authorities.  Such other Party shall then prepare the
response to the communication.  Before
submitting such response to a Regulatory Authority regarding the communication,
the Party that originally received the communication shall have an opportunity to
comment on the response to the extent such response may affect its rights or
obligations under this Agreement.  In the
event the Parties disagree concerning the form or content of a response to a
Regulatory Authority in a particular Territory, the Party in whose Territory
such Regulatory Authority is located shall decide the appropriate form and
content of such response.  The other
Party shall fully cooperate with and assist such Party in complying with such
regulatory obligations and communications, including


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


34

















 


by providing to such
Party, within two (2) business days after a request, such information and documentation
in the other Party’s possession as may be necessary or helpful for the Party to
prepare a response to an inquiry from a Regulatory Authority.  If a Party is required to respond to any
Regulatory Authority in the other Party’s Territory, such Party shall make
diligent efforts to seek the input and approval of the other Party before
responding.  Each Party shall also
provide the other Party in a timely manner with a copy of all correspondence
received from a Regulatory Authority specifically regarding the matters
referred to above. For clarity, Affymax’s obligations under this Section 4.9(a) shall
apply to any such communications regarding the matters referred to above
received by Affymax’s Affiliate(s) or Affymax’s Third Party Partner(s) as
if such communications had been received by Affymax directly.


 


(b)                                  Collaborator Disclosures
to Affymax. 
In
addition to its obligations under Section 4.9(a), Collaborator shall disclose to Affymax the information
set forth in Section 4.2(d).


 


4.10                        Regulatory Inspection or Audit.


 


(a)                                  If a Regulatory Authority desires to
conduct an inspection or audit with regard to the Product of Collaborator’s facility or a facility under contract
with Collaborator in or for the Licensed Territory, Collaborator
shall permit and cooperate with such inspection or audit, and shall cause the
contract facility to permit and  cooperate with such Regulatory Authority and Affymax
during such inspection or audit. 
Following receipt of the inspection or audit observations of such
Regulatory Authority (a copy of which Collaborator shall immediately provide to Affymax), Collaborator shall prepare the response to any such
observations, and shall provide a copy of such response to Affymax that has
been translated into English. 
Collaborator agrees
to conform its activities under this Agreement to any commitments made in such
a response, except to the extent it believes in good faith that such commitments
violate applicable Laws. If a Regulatory Authority in the Licensed Territory
desires to conduct an inspection or audit of Affymax’s facility, or a facility
under contract with Affymax, with regard to the Product in the Licensed
Territory, Affymax shall cooperate and cause the contract facility to cooperate
with such Regulatory Authority and Collaborator during such inspection or
audit. Collaborator


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


35

















 


shall have the right to
have a representative observe such inspection or audit  and Collaborator shall, if requested by
Affymax, assist
Affymax in preparing for, facilitating and/or enabling such inspection or
audit.  Following receipt of the
inspection or audit observations of such Regulatory Authority, Collaborator
shall provide a copy of such observations, Affymax shall prepare a draft
response to any such observations in English, in consultation with
Collaborator, and Collaborator shall prepare and file the final response with
such Regulatory Authority.


 


(b)                                  Audit of Product
Manufacturer.  Collaborator shall notify Affymax within
forty-eight (48) hours of receipt of notification from a Regulatory Authority
of the intention of such Regulatory Authority to audit or inspect facilities
being used to conduct Finished Manufacture of the Finished Product.  Collaborator shall also provide Affymax with
copies of any written communications received from Regulatory Authorities with
respect to such facilities within seventy-two (72) hours of receipt.


 


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 set forth in the
Supply Agreement as described in Section 7.3.  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 Authorities but that Collaborator deems to be


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


36

















 


appropriate, with the
allocation of expenses incurred in connection with such recall between the
Parties to be set forth in the Supply Agreement as described in Section 7.3.  As between the Parties, Affymax shall have
the right, at its expense, to control all recalls, field corrections, and
withdrawals of any Product in the Affymax Territory, provided, however, that
Affymax shall use reasonable efforts (subject to its confidentiality
obligations to the Third Party Partner, provided that Affymax shall,
during the course of negotiation to enter into an agreement with such Third
Party Partner, use reasonable efforts to secure its right to inform
Collaborator of such event) to inform the Collaborator of such intention in advance in writing,
if such recall may reasonably have a material effect in the Licensed Territory
but such information is not otherwise required to be provided pursuant to Section 4.9(a).  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.


 


ARTICLE 5


 


COMMERCIALIZATION


 


5.1                               Commercialization in the
Licensed Territory.  Collaborator shall have sole right and responsibility for Commercializing all
Products in the Licensed Territory, as provided in this Article 5.  Collaborator shall bear all of the costs and expenses
incurred in connection with all such Commercialization.  Collaborator shall have the
right to conduct Commercialization of the Product in the Licensed Territory
subject to Section 5.4.  Upon
reasonable request of Affymax, Collaborator shall provide Affymax an opportunity to review and comment on all significant
marketing decisions for Product in the Licensed Territory, including without
limitation marketing strategy and launch decisions, and Collaborator shall
consider any comments thereon provided by Affymax in good faith, to the extent
reasonable and practicable.


 


5.2                               Pricing Approvals in the
Licensed Territory.  Collaborator shall be responsible, at its
own expense, for seeking Pricing Approval in the Licensed Territory.  Collaborator shall keep Affymax informed on
an ongoing basis of Collaborator’s strategy for seeking, and 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 406 of
the Securities Act of 1933, as amended.


 


37

















 


results it obtains in
seeking, Pricing Approval in the Licensed Territory, including, without
limitation, the results of any discussion or other communication with relevant
Governmental Authorities regarding Pricing Approval, via regular reports to the
Joint Committee no less frequently than such committee is required to meet
pursuant to Section 2.3.


 


5.3                               Pricing of the Product
in the Licensed Territory.  Collaborator shall have the sole right to
determine all pricing of the Product in the Licensed Territory.  Notwithstanding anything in this Agreement
express or implied to the contrary, Affymax shall not have any right to direct,
control, or approve Collaborator’s pricing of Products for the Licensed Territory.  The provision to Affymax of any pricing data
is for informational purposes only.


 


5.4                               Collaborator Performance.


 


(a)                                  Level of Efforts. 
Collaborator shall devote Diligent Efforts to Commercializing each
Product in the Licensed Territory following Regulatory Approval of Products in
the Licensed Territory in accordance with this Agreement.


 


(b)                                  Time to Launch Product. 
In addition to the requirements under Section 5.4(a) and
subject to timely supply of Bulk Hematide by Affymax pursuant to Article 7
or the Supply
Agreement (defined below),
Collaborator shall achieve First Commercial Sale of each Product in the Licensed
Territory promptly after,
but in no event more than [ * ] months
after, the date on which Pricing Approval is granted for such Product in the
Licensed Territory.


 


(c)                                  Reports.  Collaborator shall update Affymax periodically regarding Collaborator’s
significant Commercialization activities with Products in the Licensed
Territory.  In addition, Collaborator
shall present a written report to Affymax at least semi-annually (and no later
than April 30th and October 31st of each year) summarizing Collaborator’s
significant Commercialization activities with respect to Products in the
Licensed Territory pursuant to this Agreement, covering subject matter at a
level of detail reasonably sufficient to enable Affymax to determine
Collaborator’s compliance with its diligence obligation pursuant to this Section 5.4.


 


5.5                               Compliance. Each Party shall comply in all material respects
with all applicable Laws  relating to
activities performed or to be performed by such Party  (or its Affiliates,


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


38

















 


contractor(s) or sublicensee(s)) under or in relation to this Agreement.  Each Party represents, warrants and covenants to the other Party that, as of the Effective Date and during the
Term, such Party and its Affiliates have adequate
procedures in place: (i) to ensure their compliance with such Laws; (ii) to
bring any noncompliance therewith by any of the foregoing entities to its attention; and (iii) to promptly
remedy any such noncompliance.  Notwithstanding the foregoing,
this Section 5.5 shall not expand Affymax’s obligations with respect to
compliance with GMP as expressly set forth in this Agreement or as otherwise
agreed upon under the quality agreement to be entered into pursuant to Section 7.8.


 


5.6                               Product Trademark and Affymax
House Marks.


 


(a)                                  Product Trademark.  Collaborator shall have the right, at its sole
discretion, to select
the trademark to be used in connection with the Commercialization of the Product in the Licensed
Territory, and shall
have all rights in and to such Product trademark. In case Collaborator desires
to use, for the Product, the trademark(s) owned by Affymax and
corresponding to the trademarks to be used for the Product in the Affymax
Territory, then, Collaborator may propose to obtain a license to such trademark(s) under
terms and conditions to be separately agreed upon by the Parties.


 


(b)                                  Affymax House
Marks.  To the extent allowable by applicable Law in the
Licensed Territory, Product packaging, Promotional Materials and Product
Labeling for use in the Licensed Territory shall carry, in a conspicuous location, the
Affymax House Marks, subject to Collaborator’s reasonable approval of the size,
position and location thereof.  From time to time during the Term,
Affymax shall have the right to obtain from Collaborator samples of Product
sold by Collaborator or its Affiliates or sublicensees in the Licensed
Territory.  Affymax shall use such
Product samples solely to inspect the quality of such Products and use of the
Affymax House Mark.


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


39

















 


ARTICLE 6


 


LICENSES AND EXCLUSIVITY


 


6.1                               Licenses to Collaborator
under Affymax Technology.  Subject to the terms and conditions of this
Agreement, including without limitation Section 8.1(b), Affymax hereby
grants Collaborator an exclusive (even as to Affymax), royalty-bearing (during the Term)
license under the
Affymax Technology to use and import Hematide in the Licensed Territory, to
Develop (as and to the extent permitted in this Agreement), use, sell, offer
for sale, and import the Product in the Licensed Territory, and to make and
have made the Finished Product anywhere in the world for such Development or
sale (subject to Article 7) in the Licensed Territory.  The license granted in this Section 6.1
may be sublicensed by Collaborator to any Affiliate of Collaborator.  The license granted in this Section 6.1
may be sublicensed by Collaborator to Third Parties only with the prior written
consent of Affymax, not to be unreasonably withheld.  For clarity, the foregoing license does not
permit Collaborator to Develop using the Affymax Technology any Alternative
ESAs, Backup Product, or any other derivative or analogue of the Peptide, [ *
], Hematide or the Product, except to the extent it obtains such right pursuant
to Section 3.6.


 


6.2                               Limited License for Affymax House Marks.


 


(a)                                  Affymax hereby grants to Collaborator a non-exclusive,
royalty-free license within the Licensed Territory to use and display the
Affymax House Marks solely in the Promotional Materials and the Product
Labeling in connection with the Commercialization of the Product within the
Licensed Territory, as provided under and in accordance with Section 5.6(b) of
this Agreement.  The
foregoing license may be sublicensed by Collaborator to its Affiliates and Third Parties sublicensees under the license granted in Section 6.1
that are approved by Affymax in accordance with Section 6.1.


 


(b)                                  Standards
for Using Affymax House Marks.  Collaborator shall provide Affymax with
exemplars and/or representative samples of any Promotional Materials and
Product Labeling containing any Affymax House Mark prior to using or
disseminating such materials.  Affymax shall
have the right to make reasonable objections to any such
materials within ten (10) days of Affymax’s receipt of such copies on the
grounds that Affymax believes in good faith that the use of such materials will
damage the reputation for quality associated with


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


40

















 


the Affymax House
Marks.  Collaborator agrees to modify such Promotional Materials and
Product Labeling in accordance with such objections of Affymax.  Collaborator acknowledges Affymax’s sole
ownership of the Affymax House Marks and agrees not to take any action
inconsistent with such ownership. 
Collaborator shall not use the Affymax House Marks in a way that would
adversely affect their value. 
Collaborator covenants that it shall not use any trademark confusingly
similar to any Affymax House Marks in connection with any products (including
the Product). Collaborator shall comply with reasonable policies provided by Affymax
from time to time to maintain the goodwill and value of the Affymax House Marks.  In any Collaborator materials in which the
Affymax House Marks appear, Collaborator shall display a trademark legend in
substantially the following form (tailored to reflect which trademark is being
used):  “{trademark}TM” is a trademark owned by Affymax” Affymax grants no rights in the Affymax House Marks
other than those expressly granted in this Section 6.2.


 


6.3                               License to Affymax under
Collaborator Technology.  Subject to the terms and
conditions of this Agreement, Collaborator hereby grants to Affymax a
non-exclusive, royalty-free license under the Collaborator Technology to
develop, use, sell, offer for sale, and import the Product in the Affymax
Territory, and to make and have made the Product or the Peptide or the Bulk
Hematide or the Finished Product anywhere in the world for such development or
sale in the Affymax Territory.  Such license shall be
sublicenseable by Affymax to any Affiliate of Affymax.  Such license shall also be sublicenseable to
any Third Party Partner or any other Third Party, with written notification
to Collaborator promptly following the grant of such sublicense.


 


6.4                               Negative Covenant.  Each Party covenants that it shall not use or practice
any of the other Party’s intellectual property rights licensed to it under this
Article 6 except for the purposes expressly permitted in the applicable
license grant under this Agreement.


 


6.5                               No Implied Licenses. 
Except as explicitly set forth in this Agreement, neither Party grants
any license, express or implied, under its intellectual property rights to the
other Party.


 


6.6                               Exclusivity.  If, during the Term, Collaborator and/or its Affiliates, either on their own or in collaboration with a Third
Party, actually market,
promote, or sell in the Licensed


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


41

















 


Territory any therapeutic
agent, other than the Product, that [ * ], without
Affymax’s prior written consent, then Affymax may, [ * ],
upon written notice to Collaborator, in Affymax’s sole discretion, either [ * ] to Collaborator [ * ] or [ * ], in each case upon ninety (90) days’ prior written
notice to Collaborator.  For avoidance of doubt, this Section 6.6
does not restrict Collaborator’s or its Affiliates’ [ * ]
activities with regard to [ * ], provided
that Collaborator acknowledges that [ * ] under [ * ] to conduct such activities.


 


6.7                               Third Party
Licenses.  Collaborator understands and acknowledges
that certain rights contained within the Affymax Technology have been licensed
to Affymax from certain Third Parties pursuant to those license agreements entered into as of the
Effective Date and set forth in Exhibit I (the “Third Party
License Agreements”).  Affymax
shall, during the Term, [ * ] Third
Party License Agreements [ * ] Third
Party License Agreements in a manner that would [ * ]
on [ * ] and Collaborator’s [ * ]
Product in the Field and in the Licensed Territory.


 


ARTICLE 7


 


MANUFACTURE AND SUPPLY


 


7.1                               Roles of the Parties.  Affymax shall supply, or cause to be supplied
through its Third Party contract manufacturers, in a timely manner
Collaborator’s entire requirements of the Bulk Hematide for Development and Commercialization purposes in or for the Licensed
Territory.  Collaborator shall be responsible for the
formulation of Bulk Hematide into the Finished Product and the manufacture of Finished
Product for both Development and Commercialization purposes in the Licensed Territory.


 


7.2                               Preclinical and Clinical
Supply of Bulk Hematide. Affymax shall, by itself or through its Third Party contract manufacturer, supply to
Collaborator, upon written request by Collaborator under the terms and
conditions of this Article 7, all quantities of Bulk Hematide reasonably
required by Collaborator, to Develop the Product in the Licensed Territory
pursuant to the Development Plan.  Such
quantities of Bulk Hematide, and the schedule for such supply, shall be
confirmed and if necessary updated by the Joint Committee in a manner consistent with the Development
Plan.  From time to time, Collaborator
shall submit to Affymax purchase orders


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


42
















 


for quantities of Bulk
Hematide for such use consistent,  as far as reasonably practicable, with such confirmed, or, if
applicable, updated
quantity and schedule, and Affymax shall supply or have supplied to
Collaborator such quantities of Bulk Hematide. 
The price for such Development (non-clinical and clinical) supply shall be [ * ] for such
Bulk Hematide, with such supply to be [ * ]. 
Affymax shall invoice Collaborator for such Bulk Hematide with each
shipment, and Collaborator shall pay such invoices within thirty (30) days of
its receipt of such invoice.  Within
sixty (60) days after the Effective Date, the Parties shall discuss and agree
upon the terms pursuant to which Affymax may provide to Collaborator reasonable
quantities of reference standard compounds and related substances to the extent
reasonably necessary for Collaborator to Develop formulations of the
Products.  Affymax shall notify
Collaborator of the identity of any Third Party contract manufacturers of Bulk
Hematide that will manufacture Bulk Hematide for supply to Collaborator
promptly after Affymax enters into an agreement with any such Third Party.


 


7.3                               Commercial Supply of
Bulk Hematide.  The Parties shall negotiate in good faith
and enter into a manufacturing and supply agreement (the “Supply Agreement”) governing the supply, by or on behalf of Affymax, to Collaborator of Bulk Hematide,  for the manufacture of
Finished Product in connection with the Commercialization of the Product by
Collaborator hereunder,
prior to [ * ] for the Product in the Licensed
Territory, or [ * ], whichever is earlier. 
Such Supply Agreement shall contain customary terms governing such
manufacturing and supply relationship, and shall provide that such Bulk
Hematide meeting the agreed specifications shall be supplied by or on behalf of Affymax to
Collaborator in a timely manner at a cost [ * ] such Bulk
Hematide, with such supply to be [ * ]. 
In addition, such Supply Agreement shall provide that Affymax shall [ * ] to ensure that Affymax meets its obligation to supply appropriately forecasted quantities of Bulk
Hematide ordered by Collaborator, and that if Affymax materially fails to meet
such supply obligation, then Collaborator shall have the right to [ * ], without delay, of [ * ]
necessary to [ * ] or [ * ]
Bulk Hematide to meet its requirements. 
If [ * ] occurs, Affymax would [ * ] any additional [ * ] necessary
to [ * ] the [ * ]
without requiring Collaborator [ * ] for such [ * ].


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


43

















 


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 by Affymax
and/or its Third Party Partners 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 by Affymax and/or its Third Party Partners for use in the Affymax Territory.


 


7.5                               Comparator Drugs.  Collaborator shall be responsible for obtaining, at
its sole expense, all supplies of its requirements of all comparator drugs
and/or placebos necessary for conducting clinical trials of the Product in the
Licensed Territory, provided, however, Affymax shall reasonably
cooperate with Collaborator for such purposes at Collaborator’s expense, which
cooperation shall include the transfer to Collaborator of technology Controlled
by Affymax relating to activities that were conducted by Affymax as of the
Effective Date with respect to any such placebo, in connection with the
Development of Products.


 


7.6                               Audit.   Affymax shall use
Diligent Efforts to minimize the Manufacturing Cost while assuring quality of
Bulk Hematide, and shall consider in good faith all reasonable input from
Collaborator for such purpose. Affymax shall maintain complete and accurate records
in sufficient detail to permit Collaborator to confirm the accuracy of the
calculation of Manufacturing Cost and resulted supply price payments
due under this
Agreement.  Upon reasonable prior notice,
such records shall be available during regular business hours for a period of
three (3) years from the creation of individual records for examination at
Collaborator’s expense, and not more often than once each calendar year, by an
independent certified public accountant selected by Collaborator and reasonably
acceptable to Affymax, for the sole purpose of verifying the accuracy of the
calculation of the supply price pursuant to this Agreement.  Any such auditor shall not disclose Affymax’s
Confidential Information, except to the extent such disclosure is necessary to
verify the accuracy of amount of supply price due by Collaborator under this
Agreement.  Any amounts determined by
such auditor to be overpaid, if any, shall be


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


44

















 


reimbursed to
Collaborator within thirty (30) days from issuance of its report, plus interest
(as set forth in Section 8.7) from the original due date.  Any amounts determined to be underpaid shall
be paid within thirty (30) days from the accountant’s report.  Collaborator shall bear the full cost of such audit
unless such audit discloses an overpayment of the amount actually owed during
the applicable calendar year of more than [ * ], in which
case Affymax shall bear the full cost of such audit.


 


7.7                               Collaborator Audit Right
of Bulk Hematide Facility. If, in order to fulfill its obligations as a holder of
a CTA or Regulatory Approval with regard to the Product in the Licensed
Territory, Collaborator desires to conduct an inspection or audit of Affymax’s
facility or a facility of a Third Party contract manufacturer under contract with Affymax
for the manufacture and supply of the Bulk Hematide in or for the Licensed
Territory, Affymax shall allow Collaborator to make such inspection or audit of
any such Affymax facility, and shall exercise its rights under any agreement
between Affymax and any such Third Party contract manufacturer to enable Collaborator to
make such inspection or audit of such Third Party contract manufacturer’s facility, in each
case to the extent relevant to the Bulk Hematide supplied in or for the Licensed Territory
and during normal business hours. Affymax shall reasonably cooperate with
Collaborator to facilitate such inspection or audit. Any such inspection or
audit by Collaborator pursuant to this Section 7.7 shall be conducted no
more frequently than once every two (2) years at a given facility, and
shall occur upon a minimum of three (3) months’ prior written notice by
Collaborator of its desire for such inspection or audit. Notwithstanding the
foregoing, if any notice or observation is made by a Regulatory Authority of
noncompliance of such facility with applicable Law in connection with Bulk
Hematide, Collaborator may conduct an inspection or audit of such manufacturing
facility more frequently than provided in the prior sentence to the extent
necessary to confirm that the relevant matters in such notice or observation
are adequately addressed. The Supply Agreement shall include additional rights
of audit and inspection of facilities used to manufacture Bulk Hematide to be
supplied to Collaborator in circumstances other than those described in this Section 7.7,
to the extent and on such terms as the Parties may reasonably agree.


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


45

















 


7.8                               Quality
Agreement.   The Parties shall
negotiate in good
faith and enter into a quality agreement governing the quality control, quality
assurance and validation of the commercial and clinical supply of the Bulk Hematide to Collaborator by or on behalf of
Affymax.  The Parties acknowledge and
understand that, in order for the Product to be Commercialized in the Licensed
Territory, Bulk Hematide supplied to Collaborator by Affymax hereunder must be
manufactured, handled and stored in compliance with the GMP required by
MHLW.  Accordingly, the quality agreement
shall incorporate a provision stating that, should GMP as required by the MHLW impose
additional or different obligations than are imposed under GMP as required by
the FDA, then Affymax shall, itself or through a Third Party contract
manufacturer, comply with such MHLW GMP requirements with respect to Bulk
Hematide supplied to Collaborator pursuant to this Agreement; provided that (i) Collaborator
has previously notified Affymax in writing of such additional or different
obligations, (ii) Affymax shall have a reasonable time after receiving
such notice to comply with such additional or different obligations, and (iii) that
Collaborator shall cooperate with Affymax to a reasonable extent to enable
Affymax to comply with such obligations.


 


ARTICLE 8


 


COMPENSATION


 


8.1                               License Fee.


 


(a)                                  No later than five
(5) business days after Collaborator’s receipt from
Affymax of two original copies of a Tax Residence Certificate (as defined in Section 8.5(c))
and two copies with original signatures, properly completed by Affymax, of each
of the other document(s) necessary to claim the benefit of an income tax
treaty (i.e., Form 3, “Application Form for Income Tax Convention,”
and Form 17, “Attachment
Form For Limitation On Benefits Article”), Collaborator shall pay to Affymax a license fee of
Seventeen Million Dollars ($17,000,000) by wire transfer of immediately
available funds into the account designated by Affymax to Collaborator prior to the Effective
Date.  Such license fee shall be
nonrefundable and noncreditable against any other payments due hereunder.  Collaborator shall confirm to 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 406 of
the Securities Act of 1933, as amended.


 


46

















 


in writing or by
electronic means that such amount has been transferred to Affymax’s account
promptly after such event occurs.


 


(b)                                  Within five (5) business days after
the Effective Date, Collaborator shall purchase Ten Million Dollars
($10,000,000) worth of shares of Affymax’ non-voting, preferred stock, at a price of $4.7162 (i.e., one hundred and
twenty-five (125%) of the price per share of the Series D preferred stock
of Affymax)  per
share, pursuant to the Stock Purchase Agreement attached hereto as Exhibit J.  
Notwithstanding the foregoing, if Affymax is unable to have its
certificate of incorporation enabling the foregoing purchase by Collaborator of
shares of Affymax’ stock filed and accepted by relevant authorities within the
first three (3) business days of such five (5) business day period,
then the Parties will mutually agree upon a reasonable extension of the time
required for Collaborator to purchase such stock after such certificate is so
filed and accepted (not to exceed three (3) business days after such
certificate is so filed and accepted).


 


8.2                               Clinical Milestone
Payments.  Collaborator shall make milestone
payments to Affymax based on the first achievement of each milestone event in the Licensed
Territory for the Product as set forth in this Section 8.2.  Collaborator shall pay to Affymax the amounts
set forth below within thirty (30) days after the first achievement of the corresponding
milestone event.  Each milestone payment
by Collaborator to Affymax hereunder shall be payable [ * ]
achieved by one or more Products.  Each
such payment shall be made by wire transfer of immediately available funds into
the account set forth in Section 8.1
unless otherwise designated
in writing by
Affymax.  Each such payment is
nonrefundable and noncreditable against any other payments due hereunder.


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


47

















 


	
  Milestone Event

  	
   

  	
  Milestone Payment

  	
   

  
	
  Completion** of the first Phase I Clinical Trial for
  the Product by or on behalf of the Collaborator

  	
   

  	
  $

  	
  10,000,000

  	
   

  
	
  [ * ]

  	
   

  	
  $

  	
  [ * ]

  	
   

  
	
  [ * ]

  	
   

  	
  $

  	
  [ * ]

  	
   

  
	
  [ * ]

  	
   

  	
  $

  	
  [ * ]

  	
   

  
	
  [ * ]

  	
   

  	
  $

  	
  [ * ]

  	
   

  
	
  [ * ]

  	
   

  	
  $

  	
  [ * ]

  	
   

  
	
  [ * ]

  	
   

  	
  $

  	
  [ * ]

  	
   

  
	
  [ * ]

  	
   

  	
  $

  	
  [ * ]

  	
   

  
	
  [ * ]

  	
   

  	
  $

  	
  [ * ]

  	
   

  
	
  [ * ]

  	
   

  	
  $

  	
  [ * ]

  	
   

  
	
  Total Milestone Payments

  	
   

  	
  $

  	
  75,000,000

  	
   

  



 






* 
“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.


 


8.3                               Royalties.


 


(a)                                  Rate for Patented Products.  On a product by product
basis, Collaborator
shall pay to Affymax royalties based on the aggregate annual Net Sales of each Product
sold in the Licensed
Territory  at the rate of [ * ] at all times at which a Valid Claim of an Affymax
Patent or a Joint Patent covering the composition of matter of such Product
(including without limitation the composition of matter of Hematide) exists in
the Licensed 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 406 of
the Securities Act of 1933, as amended.


 


48

















 


(b)                                  Royalty Rate Step Down;
Term of Obligation.  Collaborator acknowledges that it will
continue to enjoy substantial benefit from its license under, and the transfer
to Collaborator of certain elements of, the Affymax Technology pursuant to this
Agreement (including without limitation the Affymax Know-How licensed to Collaborator,
and the regulatory data to be provided to Collaborator, pursuant to this
Agreement) as well as from Collaborator’s own development of Collaborator
Technology derived from the practice of such license and Collaborator’s use of
such Affymax Technology, even after expiration of all Valid Claims of the
Affymax Patents and Joint Patents covering the composition of matter of
Products in the Licensed Territory, determined on a Product by Product basis
(the date upon which the last to expire of such Valid Claims occurs for a Product, the “Expiration Date”).  Accordingly, Collaborator shall, on a Product by
Product basis,
continue to pay royalties on Net Sales of Products by Collaborator, its
Affiliates and sublicensees after the Expiration Date, in consideration for the
foregoing non-patent benefits, as follows: 
After the Expiration Date, Collaborator shall pay to Affymax royalties
on Net Sales of such Products at a rate of [ * ] provided,
however, that Collaborator’s obligation to pay such royalty on such Product
shall terminate at the end of the first to occur [ * ]
in which [ * ] of such Product in the Licensed
Territory comprising, during such time period, [ * ]
or more of the [ * ] of such Product and [ * ] sold in such time period in the Licensed Territory
(based upon mutually acceptable Third Party objective data sources).


 


(c)                                  Royalty Payments and
Reports. All
amounts payable to Affymax pursuant to Sections 8.3(a) or (b) shall
be paid in Dollars within forty-five (45) days after the end of each calendar quarter
with respect to Net Sales in such calendar quarter.  Each payment of royalties due to Affymax
shall be accompanied by a statement of the amount of gross sales of Product in
the Licensed Territory during the applicable calendar quarter, an itemized calculation
of Net Sales in the Licensed Territory showing deductions provided for in Section 1.48
during such calendar quarter, and a calculation of the amount of royalty
payment due on such sales for such calendar quarter.  Collaborator shall require its sublicensees
to account for their Net Sales and to provide such reports with respect thereto
as if such sales were made by Collaborator.


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


49

















 


8.4                               Existing and Future Third Party Royalties.


 


(a)                                  In addition to the royalties owed pursuant to Section 8.3,
except as otherwise provided in Section 8.4(c), Collaborator shall
reimburse Affymax for all royalties due to Third Parties pursuant to the Third
Party License Agreements with respect to Commercialization of Products in the
Licensed Territory by Collaborator, its Affiliates or sublicensees, and for all
royalties required to be paid to Third Parties under any other future license
agreements entered into between
a Third Party and Affymax (“Future Third Party
Licenses”) with respect to  Collaborator’s, its Affiliate’s, or its sublicensees’
Development and/or Commercialization of Products in the Licensed
Territory.  Affymax shall consult in good
faith with Collaborator prior to entering into any Future Third Party Licenses
(other than any such Future Third Party License [ * ],
as described in Section [ * ]).


 


(b)                                  In addition, except as otherwise provided in Section 8.4(c),
to the extent Collaborator enters into any license agreement with any Third
Party to obtain a license or other right to Develop, use, conduct Finished
Manufacture of, or Commercialize the Product in the Licensed Territory after the
Effective Date, Collaborator
shall make all such payments to such Third Parties.  Except as provided in Section 8.4(c),
Collaborator shall have no right to offset or otherwise deduct such payments
that it makes or pays to any Third Party as described in this Section 8.4(b) or
in Section 9.6(d) from any amounts otherwise owed Affymax under this
Agreement.


 


(c)                                  In the event [ * ] enters
into a license agreement [ * ] with [ * ] and/or any of its affiliates after the Effective Date
obtaining rights including in the Licensed Territory under certain Patents listed on [ * ] and pursuant to such agreement is required to pay to [ * ] and/or its affiliate royalties or milestones with
respect to Collaborator’s Development or Commercialization of the Product for
or in the Licensed Territory, Collaborator shall reimburse
Affymax for all such royalties and milestone payments reasonably applicable to such activities in or for the Licensed Territory that are due [ * ] and/or such affiliate,
provided that Collaborator is provided [ * ] Affymax [ * ] such agreement reasonably prior to [ * ]. 
Notwithstanding the foregoing, Collaborator shall have the
right to [ * ] any such reimbursed royalties [ * ] of this Agreement [ * ].
Alternatively, if it becomes necessary for Collaborator to enter into a license
agreement directly with [ * ] or its
affiliate to obtain rights under [ * ] with
respect to such


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


50

















 


activities
in or for the Licensed Territory, Collaborator shall have the right to [ * ] any royalties paid to [ * ]
and/or its affiliate [ * ] for the same [ * ], provided
that Collaborator shall inform Affymax that it
intends to [ * ] and/or its affiliates and obtain Affymax’s
consent with respect thereto (which consent shall not be unreasonably withheld or delayed) prior to its start of the [ * ]
or its affiliate with respect to such [ * ], and further provided that, [ * ],
Collaborator shall give Affymax  [ * ]. Affymax shall have the right to
consent (which consent shall not be
unreasonably withheld or delayed) to [ * ] in any such agreement that would
bind Affymax conduct. Notwithstanding anything to the contrary in the
foregoing, in no event shall [ * ] under
this Section 8.3(c) [ * ] to
Affymax to [ * ] of the [ * ]
Affymax under [ * ].


 


(d)                                  On a quarterly basis, Affymax shall invoice
Collaborator for all such payments which Affymax actually paid during such quarter to Third Parties
to which royalties are due as set forth in Section 8.4(a), and
Collaborator shall pay to Affymax such invoiced amount within thirty (30) days.


 


8.5                               Taxes.


 


(a)                                  Cooperation and
Coordination.  The Parties acknowledge and agree that it
is their mutual objective and intent to minimize, to the extent feasible and
legal, taxes payable with respect to their collaborative efforts under this
Agreement and that they shall use all commercially reasonable efforts to
cooperate and coordinate with each other to achieve such objective.


 


(b)                                  Payment of Tax.  A Party receiving a payment pursuant to this Article 8
shall pay any and all taxes levied on such payment.  If applicable Law requires that taxes be
deducted and withheld from a payment made pursuant to this Article 8, the
remitting Party shall (i) deduct those taxes from the payment; (ii) pay
the taxes to the proper taxing authority; and (iii) send evidence of the
obligation together with proof of payment to the other Party within sixty (60)
days following that payment.


 


(c)                                  Tax Residence
Certificate.  A Party (including any entity to which
this Agreement may be assigned, as permitted under Section 15.5) receiving
a payment pursuant to


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


51

















 


this Article 8 shall
provide the remitting Party appropriate certification from relevant revenue
authorities that such Party is a tax resident of that jurisdiction (a “Tax Residence Certificate”), if such
receiving Party wishes to claim the benefits of an income tax treaty to which
that jurisdiction is a party.  Upon the
receipt thereof, any deduction and withholding of taxes shall be made at the
appropriate treaty tax rate.


 


(d)                                  Assessment.  Either Party may, at its own expense, protest any
assessment, proposed assessment, or other claim by any Governmental Authority
for any additional amount of taxes, interest or penalties or seek a refund of
such amounts paid if permitted to do so by applicable Law.  The Parties shall cooperate with each other
in any protest by providing records and such additional information as may
reasonably be necessary for a Party to pursue such protest.


 


8.6                               Foreign Exchange. 
The rate of exchange to be used in computing the amount of currency
equivalent in Dollars owed to a Party under this Agreement shall be made at the
period-end rate of exchange quoted on the last business day of the applicable
calendar quarter by Citibank in New York City.


 


8.7                               Late Payments. 
If Affymax does not receive payment of any sum due to it on or before
the due date, simple interest shall thereafter accrue on the sum due to Affymax
until the date of payment at the per annum rate of [ * ]
over the then-current prime rate quoted by Citibank in New York City, or the
maximum rate allowable by applicable Law, whichever is lower.


 


8.8                               Records; Audits.  Collaborator shall maintain complete and
accurate records in sufficient detail to permit Affymax to confirm the accuracy
of the calculation of royalty payments under this Agreement.  Upon reasonable prior notice, such records
shall be available during regular business hours of Collaborator for a period of three (3) years from
the creation of individual records for examination at Affymax’ expense, and not
more often than once each calendar year, by an independent certified public
accountant selected by Affymax and reasonably acceptable to Collaborator, for
the sole purpose of verifying the accuracy of the financial reports furnished
by Collaboration pursuant to this Agreement. 
Any such auditor shall not disclose


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


52
















 


Collaborator’s
Confidential Information, except to the extent such disclosure is necessary to
verify the accuracy of the financial reports furnished by Collaborator or the
amount of payments due by Collaborator under this Agreement.  Any amounts shown to be owed but unpaid shall
be paid within thirty (30) days from the accountant’s report, plus interest (as
set forth in Section 8.7) from the original due date.  Any amounts determined to be overpaid shall
be refunded within thirty (30) days from the accountant’s report.  Affymax shall bear the full cost of such
audit unless such audit discloses an underpayment of the amount actually owed
during the applicable calendar year of more than [ * ]
in which case Collaborator shall bear the full cost of such audit.


 


ARTICLE 9


 


INTELLECTUAL PROPERTY MATTERS


 


9.1                               Ownership of Inventions. 
Each Party shall own any inventions made solely by its employees,
agents, or independent contractors in the course of conducting its activities
under this Agreement, together with all intellectual property rights therein (“Sole Inventions”).  Any inventions that are made jointly by
employees, agents, or independent contractors of each Party in the course of
performing activities under this Agreement, together with all intellectual property
rights therein (“Joint Inventions”)
shall be owned jointly by the Parties in accordance with joint ownership
interests of co-inventors under U.S. patent laws, with each joint Party having, unless
otherwise set forth in this Agreement (including without limitation Section 9.3), the unrestricted right to license and
grant rights to sublicense each such Joint Invention.  Inventorship shall be determined in
accordance with U.S. patent laws.  Sole
Inventions owned by Collaborator and Collaborator’s interest in all Joint
Inventions shall be included in the Collaborator Technology.  Sole Inventions owned by Affymax and Affymax’
interest in all Joint Inventions shall be included in the Affymax Technology.


 


9.2                               Disclosure of
Inventions.  Each Party shall promptly disclose to the other any invention
disclosures, or other similar documents, submitted to it by its employees,
agents or independent contractors describing inventions that may be either Sole
Inventions or Joint Inventions, and all Information relating to such
inventions.


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


53

















 


9.3                               Prosecution of Patents.


 


(a)                                  Affymax Patents Other
than Joint Patents.  Except as otherwise provided in this Section 9.3(a),
Affymax shall have the sole right and authority to file, prosecute and maintain
the Affymax Patents other than Joint Patents on a worldwide basis. Affymax
shall provide Collaborator reasonable opportunity to review and comment on such
prosecution efforts regarding such Affymax Patents in the Licensed Territory.  Affymax shall provide Collaborator with a
copy of material communications from any patent authority in the Licensed
Territory regarding such Affymax Patents, 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.    Notwithstanding the foregoing,
if Affymax desires to abandon or not maintain any Patent
within such Affymax Patents in the Licensed Territory, then Affymax shall
provide Collaborator with thirty (30) days prior written notice of such desire (or such longer period of time as
reasonably necessary to allow Collaborator to assume such responsibilities) and, if Collaborator
so requests, shall
provide Collaborator with the opportunity to prosecute and maintain such Patent
in the Licensed Territory in place of Affymax, at Collaborator’s sole expense, in which
case Affymax shall assign such Patent in the Licensed Territory to Collaborator
(and such Patent shall thereafter be included in the Collaborator
Patents).  If Collaborator desires
Affymax to file, in the Licensed Territory, a patent application that claims
priority from a Patent within the Affymax Patents, other than a Joint Patent,
in the Licensed Territory, Collaborator shall provide written notice to Affymax
requesting that Affymax file such patent application in the Licensed
Territory.  If Collaborator provides such written notice
to Affymax, Affymax shall either (i) file and prosecute such patent
application and maintain any patent issuing thereon in the Licensed
Territory, at Collaborator’s expense, or (ii) notify
Collaborator that Affymax does not desire to file such patent application and
provide Collaborator with the opportunity to file and prosecute such patent
application and maintain any patent issuing thereon in the Licensed Territory in place of Affymax, at Collaborator’s sole expense,
in which case Affymax shall assign such patent application
described in (ii) to Collaborator in the Licensed Territory (and in which
case such Patent shall be included in the Collaborator Patents). If at any time
Collaborator receives notices from the Japanese Patent


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


54

















 


Office
regarding patent claims or prosecution communications for an Affymax Patent,
Collaborator shall send such notices to Affymax within two (2) weeks after
receipt of such notices.  If Affymax
assigns a Patent to Collaborator pursuant to this Section 9.3(a),
Collaborator shall not file any patent claims or any prosecution communications
with respect thereto in the Licensed Territory without the prior written
consent of Affymax, or undertake any patent prosecution or enforcement action
with respect thereto in the Licensed Territory, that Affymax deems to be
detrimental to the prosecution and enforcement of Affymax Patents in the
Affymax Territory.


 


(b)                                  Collaborator Patents
Other Than Joint Patents.  Except as otherwise provided
in this Section 9.3(b), Collaborator shall have the sole right and
authority, but not an obligation, to prosecute and maintain the Collaborator Patents other than Joint
Patents on a worldwide basis at its sole discretion (subject to this Section 9.3(b))
and at own cost and responsibility.  Collaborator
shall provide Affymax reasonable opportunity to review and comment on such prosecution
efforts regarding such Collaborator Patents. 
Collaborator shall provide Affymax with a copy of material
communications from any patent authority regarding such Collaborator Patents,
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.    If
Collaborator determines in its sole discretion to abandon or not maintain any
Patent within the Collaborator Patents other than a Joint Patent anywhere in
the world, then Collaborator shall provide Affymax with thirty (30) days’ prior
written notice of such determination (or such longer period of time reasonably
necessary to allow Affymax to assume such responsibilities) and shall provide
Affymax with the opportunity to prosecute and maintain such Patent in the
applicable jurisdiction in place of Collaborator at Affymax’s sole expense, and if
Affymax so requests, Collaborator shall assign such Patent to Affymax (in which
case such Patent shall be included in the Affymax Patents).  If Affymax desires Collaborator to file, in a
particular jurisdiction, a patent application that claims priority from a
Patent within the Collaborator Patents, Affymax shall provide written notice to
Collaborator requesting that Collaborator file such patent application in such
jurisdiction.  If Affymax provides such
written notice to Collaborator, Collaborator shall either (i) file and
prosecute such patent application and


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


55

















 


maintain any patent
issuing thereon in such jurisdiction at Affymax’s expense, or (ii) notify Affymax
that Collaborator does not desire to file such patent application and provide
Affymax with the opportunity to file and prosecute such patent application and
maintain any patent issuing thereon at Affymax’s sole expense in place of Collaborator, in which case Collaborator
shall assign such patent application described in (ii) to
Affymax (and in which case such Patent shall be included in the Affymax
Patents).


 


(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 in the Licensed Territory, and Affymax
would prosecute and maintain the Joint Patents in the Affymax Territory,
subject to the Parties coordinating their efforts as appropriate to make such
prosecution activities as efficient, convenient and harmonious as possible.  The Party that prosecutes a patent
application in the Joint Patents (the “Prosecuting
Party”) shall bear its own costs and expenses incurred with respect
to the prosecution of such patent application, except as otherwise provided
below.  Such Prosecuting Party shall
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


 






[ * ] = 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 406 of the
Securities Act of 1933, as amended.


 


56

















 


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;
provided, however, that Collaborator shall not have the right to grant to [ * ] Territory under any Joint Patents a license to make,
use, sell, offer for sale and import  [ * ]  in the Affymax
Territory.  For clarity, Collaborator hereby consents to allow
Affymax to grant licenses under the Joint Patents as necessary to Third Parties
and to its Third Party Partner to make, use, sell, offer for sale and import the
Product, the [ * ], the Peptide, any Alternative ESAs or Bulk Hematide, or any
other composition of matter that stimulates erythropoiesis activity, in the
Affymax Territory, without further consideration from Affymax or such recipient
licensee.  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.


 


(d)                                  Cooperation in Prosecution. 
Each Party shall provide the other Party all reasonable assistance and
cooperation in the Patent prosecution efforts provided above in this Section 9.3,
including providing any necessary powers of attorney and executing any other
required documents or instruments for such prosecution.


 


9.4                               Patent Term Extensions
in the Licensed Territory.  The internal patent counsel of
each Party shall discuss and recommend for which, if any, of the Affymax
Patents, Collaborator Patents and Joint Patents in the Licensed Territory  the Parties should seek Patent Term
Extensions in the Licensed Territory, and, Affymax, in the case of the Affymax
Patents, and Collaborator in the case of the Collaborator Patents and Joint
Patents, shall have the final decision-making authority with respect to
applying for any such Patent Term Extensions in the Licensed Territory, and
shall act with reasonable promptness in light of the development stage of
Products to apply for any such Patent Term Extensions, where it so elects, provided, however,


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


57

















 


that if in the Licensed
Territory only one such Patent can obtain a Patent Term Extension, then the
Parties shall consult in good faith to determine which such Patent should be
the subject of efforts to obtain a Patent Term Extension, and Affymax’s
decision on which one Patent shall be extended shall control in the case of a
disagreement. The Party that does not apply for an extension hereunder shall
cooperate fully with the other Party in making such filings or actions, for
example and without limitation, making available all required regulatory data
and information and executing any required authorizations to apply for such
Patent Term Extension.  All activities of
the Parties pursuant to this Section 9.4 for the Licensed Territory shall be at the expense of the Party who owns such
extended Patents (in case of Joint Patents, expenses shall be shared equally by
the Parties).


 


9.5                               Infringement of Patents by Third
Parties.


 


(a)                                  Notification.  Each Party shall promptly notify
the other Party in writing of any existing or threatened infringement of the
Affymax Patents, Joint Patents or Collaborator Patents of which it becomes
aware, and shall provide evidence in such Party’s possession demonstrating such
infringement.


 


(b)                                  Infringement of Affymax Patents or Joint
Patents in the Licensed Territory.


 


(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


 






[ * ] = 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 406 of the
Securities Act of 1933, as amended.


 


58

















 


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 either (i) Affymax
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, or (ii) such
infringement suit is to be brought against [ * ], other
than with respect to Affymax Patents or Joint Patents that claim solely
Formulation Technology, and commencement of such suit or other legal proceeding
in the Licensed Territory is reasonably anticipated by Affymax to result in an
outcome that would have a substantially adverse effect on an Affymax Patent or
Joint Patent in the Affymax Territory, or on the commercialization,
manufacture, use, importation, sale or offer to sell the Product, any
Alternative ESA or Bulk Hematide in the Affymax Territory, in which case
Collaborator shall not have the right to so commence a suit or take such action
to enforce the applicable Affymax Patent or Joint Patent without Affymax’s
prior written consent.  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).


 


(ii)                                The Party not bringing an action with
respect to Product Infringement in the Licensed Territory under this Section 9.5(b) shall
be entitled to separate representation in such matter by counsel of its own
choice and at its own expense, but such Party shall at all times cooperate
fully with the Party bringing such action. Additionally, the Party not


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


59

















 


bringing an action under
this Section 9.5 may have an opportunity to participate in such action to
the extent that the Parties may mutually agree at the time the other Party
elects to bring an action hereunder.


 


(c)                                  Infringement of Affymax Patents or Joint Patents in
the Affymax Territory.


 


(i)                                    For any and all infringement of Affymax Patents other
than Joint Patents anywhere in the Affymax Territory, Affymax (or its Third
Party Partner) shall have the sole and exclusive right to bring an appropriate
suit or other action against any person or entity engaged in such infringement
of such Patents, in its
sole discretion, and as between the Parties Affymax shall bear all related expenses and
retain all related recoveries.


 


(ii)                                If a Third Party infringes a Joint Patent in the
Affymax Territory  by Product Infringement activities, Affymax (or its Third Party Partner) shall have the
sole and exclusive right to bring an appropriate suit or other action against
any person or entity engaged in such infringement of such Patents, in its sole discretion, and as between
the Parties Affymax shall bear all related expenses and retain all related
recoveries.  Collaborator shall provide
to Affymax reasonable assistance in such enforcement, at Affymax’s request and
expense, including joining such action as a party plaintiff if required by
applicable Law to pursue such action.


 


(iii)                            For infringement of the Joint Patents in the Affymax
Territory that is not Product Infringement, the Parties shall confer to
determine which Party shall have the first right to bring an appropriate suit
or other action against any person or entity engaged in such infringement, and
the manner in which they shall bear costs and share related recoveries of such
suit or action.  The Party that brings such suit or actions  (the “Enforcing Party”) shall bear its own costs and expenses
incurred.  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.  The other Party shall cooperate
with the enforcing Party in enforcing Joint Patents against the such
infringement. Each
Party shall bear all of its own internal costs incurred in connection with its
activities with respect to such


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


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infringement of such
Joint Patents.  In the event the
Parties are unable to reach agreement upon which Party shall bring an appropriate suit or other
action against any person or entity engaged in such infringement of such Joint
Patent within a reasonable time period (i.e., within ninety (90) days), either
Party may bring such suit or other actions against such infringement, and
notify the other Party of such actions. 
The other Party shall have the right to participate in such actions upon
written notice to the other Party.


 


(d)                                  Product Infringement of
Collaborator Patents (other than Joint Patents) in the Affymax Territory. 
If a Third Party infringes a Collaborator Patent (other than a Joint
Patent) in a country or jurisdiction in the Affymax Territory  by Product Infringement activities, Collaborator shall have the first right, but not the
obligation, to bring, at its own expense and in its sole control, an
appropriate suit or other action against any person or entity engaged in such
infringement of such Collaborator Patent in the Affymax Territory.  If Collaborator does not bring such action within one hundred
twenty (120) days of
notification thereof to or by Collaborator, Affymax shall have the right, but not the
obligation, to bring at its expense and in its sole control, such appropriate
action.  The Party not bringing an action
under this Section 9.5(d) shall be entitled to separate
representation in such matter by counsel of its own choice and at its own
expense, but such Party shall cooperate fully with the Party bringing such
action, including by joining such action as a party plaintiff, at the expense
of the enforcing Party,
if required by applicable Law for the enforcing Party to pursue such action.


 


(e)                                  Infringement of
Collaborator Patents (Other than Joint Patents) in the Licensed Territory. 
For all infringement of any Collaborator Patents (other than Joint
Patents) in the Licensed Territory, Collaborator shall have the exclusive
right, but not the obligation, to bring, at Collaborator’s expense and in its
sole control, an appropriate suit or other action against any person or entity
engaged in such infringement of such Collaborator Patent.


 


(f)                                    Settlement.  Collaborator shall not settle any
claim, suit or action that it brings under this Section 9.5 involving Affymax
Patents (excluding Joint Patents) in any manner that would negatively impact
Affymax Patents anywhere in the world, or that would limit or restrict the
ability of Affymax or its Third Party Partner(s) to manufacture, use,
sell, offer for sale


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


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or import Products anywhere in the world, without the
prior written consent of Affymax. Affymax shall not settle any claim, suit or
action that it brings under this Section 9.5 involving Collaborator
Patents (excluding Joint Patents) in any manner that would negatively impact
the Collaborator Patents or that would limit or restrict the ability of
Collaborator to sell Products anywhere in the world, without the prior written
consent of Collaborator.  Neither Party
shall settle any claim, suit or action that it brings under this Section 9.5
involving Joint Patents in any manner that would negatively impact the Joint
Patents or that would limit or restrict the ability of the other Party to sell
Products anywhere in the world, without the prior written consent of such other
Party.  Notwithstanding anything to the
contrary in this Section 9.5, Affymax shall have the right to withhold
consent to any settlement that is reasonably anticipated to have a
substantially adverse impact upon any Affymax Patent in the Affymax Territory,
or the commercialization, manufacture, use, importation, offer for sale or sale
of the Product, any Alternative ESA or Bulk Hematide in the Affymax Territory.


 


(g)                                 Allocation of Proceeds.  If either Party recovers monetary
damages from any Third Party in a suit or action brought under Section 9.5,
whether such damages result from the infringement of Affymax Patents, Joint
Patents or Collaborator Patents, such recovery shall be allocated first to the
reimbursement of any expenses incurred by the Parties in such litigation
(including, for this purpose, a reasonable allocation of expenses of internal
counsel), and any remaining amounts shall be, as between Affymax and
Collaborator, split
as follows:


 


(i)                                    the portion of any such remaining amounts that
represents recovery for infringement in the Licensed Territory shall be
allocated [ * ] to Affymax and [ * ] to Collaborator; and


 


(ii)                                the portion of any such remaining amounts
that represents recovery for infringement in the Affymax Territory (other than those
obtained pursuant to subsection (c), which shall be the sole property of
Affymax) shall be
allocated [ * ] to Affymax and [ * ] to Collaborator.


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


62

















 


9.6                               Infringement of Third Party
Rights in the Licensed Territory.


 


(a)                                  Notice. 
If any Product manufactured, used or sold by either Party, its
Affiliates, licensees or sublicensees becomes the subject of a Third Party’s
claim or assertion of infringement of a Patent granted by a jurisdiction within
the Licensed Territory relating to the manufacture, use, sale, offer for sale
or importation of Hematide, Peptide, [ * ] or the Product, the Party first having notice of the
claim or assertion shall promptly notify the other Party, and the Parties shall
promptly meet to consider the claim or assertion and the appropriate course of
action.


 


(b)                                  Defense. 
Affymax shall have the first right, but not the obligation, to defend
any such claim, with Affymax’s costs to conduct such defense being at Affymax’s
expense.  If Affymax does not commence
actions to defend such claim within sixty (60) days after it receives notice
thereof (or within sixty (60) days after it should have given notice thereof to
Collaborator as required by Section 9.6(a)), then Collaborator shall have
the right, but not the obligation, to control the defense of such claim by
counsel of its choice, at Collaborator’s expense. The non-defending Party shall
reasonably cooperate with the Party conducting the defense of the claim,
including if required to conduct such defense, furnishing a power of
attorney.  The non-defending Party shall
have the right to confer with the other Party in any such defense, and may have
the right to participate in any such defense to the extent that the Parties, at
such time, may mutually agree.  The
non-defending Party shall also be entitled to separate representation in such
matter by counsel of its own choice and at its own expense, provided that the
other Party shall control such defense.


 


(c)                                  Settlement. 
Neither Party shall enter into any settlement of any claim described in
this Section 9.6 that affects the other Party’s rights or interests
without such other Party’s written consent, which consent shall not be
unreasonably withheld or delayed. 
Affymax shall have the right to decline to defend or to tender defense
of any such claim to Collaborator upon reasonable notice, including without
limitation if Collaborator fails to agree to a settlement that Affymax
proposes.


 


(d)                                  Any amounts that either Party becomes obligated to pay
as a result of any settlement of or decision rendered in any defense pursuant
to this Section 9.6 with respect to 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 406 of
the Securities Act of 1933, as amended.


 


63

















 


manufacture,
use, sale, offer for sale or import of the Product in or for the Licensed
Territory shall be [ * ] and [ * ] as
provided in Section [ * ].


 


9.7                               Patent Marking. 
Collaborator (or its Affiliate, sublicensee or distributor) shall mark
Products marketed and sold by Collaborator (or its Affiliate, sublicensee or
distributor) hereunder with appropriate patent numbers or indicia at Affymax’s
request to the extent permitted by applicable Law, if such markings or such notices impact recoveries of
damages or equitable remedies available with respect to infringements of
patents in the Licensed Territory.


 


9.8                               Infringement of
Trademarks by Third Parties.  With respect
to any trademarks associated with Products within the Licensed Territory, each
Party shall notify the other Party promptly upon learning of any actual, alleged or
threatened infringement of any trademark or of any unfair trade practices,
trade dress imitation, passing off of counterfeit goods, or like offenses,
against such trademark (hereinafter “TM
Infringement”).  Collaborator shall have the sole right, in its own
discretion and at its own expense, to bring an action to address such TM
Infringement, in which case Collaborator shall retain any damages recovered from the Third
Party.  Notwithstanding the foregoing,
if  the trademark at issue is one as to which
Collaborator was granted a license by Affymax, then the Parties shall instead
proceed as provided in the relevant license agreement between the Parties with
respect to such trademark.


 


9.9                               Patent Oppositions and Other
Proceedings.


 


(a)                                  Third-Party Patent
Rights.  If either Party desires to bring an
opposition, action for declaratory judgment, nullity action, interference,
declaration for non-infringement, reexamination or other attack upon the
validity, title or enforceability of a Patent owned or controlled by a Third
Party that covers, in the Licensed Territory, the Peptide, [ * ] or the Product, or the manufacture, use,
sale, offer for sale or importation of the Peptide, [ * ] or the Product (except insofar as such
action is a counterclaim to or defense of, or accompanies a defense of, a Third
Party’s claim or assertion of infringement under Section 9.6, in which
case the provisions of Section 9.6 shall govern), such Party shall so
notify the other Party and the Parties shall promptly confer to determine
whether to bring such action or the manner in which to settle such action.  Affymax shall have the first right, but not the obligation, to bring
at its own


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


64

















 


expense and in its sole
control such action in the Affymax Territory or the Licensed Territory.  If Affymax does not bring such an action in
the Licensed Territory, within ninety (90) days of notification thereof
pursuant to this Section 9.9(a) (or earlier, if required by the
nature of the proceeding), then Collaborator shall have the right, but not the
obligation, to bring, at Collaborator’s sole expense and in Collaborator’s sole
control, such action only within the
Licensed Territory.  The Party not bringing an action under this Section 9.9(a) shall
join the action as a joint party plaintiff if required to enable the other
Party to bring such action, and the other Party’s expense.  Additionally, if appropriate, the Party not bringing an action under
this Section 9.9(a) shall be entitled to separate representation in
such proceeding by counsel of its own choice and at its own expense, and shall
cooperate fully with the Party bringing such action.  Any awards or amounts received in bringing
any such action, if any, shall be first allocated to reimburse the Parties’
expenses in such action, and any remaining amounts shall be retained by the
Party bringing such action.


 


9.10                        Parties’ Patent Rights. 
If an Affymax Patent, Joint Patent or Collaborator Patent becomes the
subject of any proceeding commenced by a Third Party within the Licensed
Territory in connection with an opposition, reexamination request, action for
declaratory judgment, nullity action, interference or other attack upon the
validity, title or enforceability thereof (except insofar as such action is a
counterclaim to or defense of, or accompanies a defense of, an action for
infringement against a Third Party under Section 9.5, in which case the
provisions of Section 9.5 shall govern), then the Party owning or
otherwise Controlling such Patent shall control such defense at its sole cost; provided that if such action relates to a
Joint Patent, the Parties shall confer and determine which Party shall control
such action and bear the associated costs. 
The controlling Party shall permit the non-controlling Party to participate
in the proceeding to the extent permissible under applicable Law, and to be
represented by its own counsel in such proceeding, at the non-controlling Party’s
expense.  If either Party decides that it
does not wish to defend against such action, then the other Party shall have a
backup right to assume defense of such Third-Party action at its own
expense.  Any awards or amounts received
in defending any such Third-Party action, if any, shall be allocated between the Parties
as


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


65

















 


provided in Section 9.5(g) as
if the Party conducting such opposition were the Party that brought an action
against an alleged infringer.


 


9.11                        Orange Book Listing,
Compendial Listing.   Upon request of Collaborator, Affymax
shall file appropriate information with the Regulatory Authority in the
Licensed Territory listing any Affymax Patents in the Orange Book equivalent in
the Licensed Territory, if any, as a Patent related to the Product and shall
use Diligent Efforts to maintain such listing.


 


9.12                        Registration of
Exclusive License.  Within a reasonable period of time after
the Effective Date, Affymax shall register before the Japan Patent Office that Collaborator
is the exclusive
licensee under the
Affymax Patents pursuant to this Agreement.


 


9.13                        Certain Patent
Matters.  With regard to [ * ] set forth in [ * ]
(collectively the [ * ]), Affymax
shall keep [ * ], and shall [ * ], to the extent consistent with Affymax’s [ * ].


 


ARTICLE 10


 


REPRESENTATIONS AND WARRANTIES


 


10.1                        Mutual Representations
and Warranties.  Each Party hereby represents, warrants, and
covenants (as applicable) to the other Party as follows:


 


(a)                                  Corporate Existence and
Power.  It is a company or corporation duly
organized, validly existing, and in good standing under the laws of the
jurisdiction in which it is incorporated, and has full corporate power and
authority and the legal right to own and operate its property and assets and to
carry on its business as it is now being conducted and as contemplated in this
Agreement, including, without limitation, the right to grant the licenses
granted by it hereunder.


 


(b)                                  Authority and Binding
Agreement.  As of the Effective Date, (i) it has the
corporate power and authority and the legal right to enter into this Agreement
and perform its obligations hereunder; (ii) it has taken all necessary
corporate action on its part required to authorize the execution and delivery
of the Agreement and the performance of its obligations


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


66

















 


hereunder; and (iii) the
Agreement has been duly executed and delivered on behalf of such Party, and
constitutes a legal, valid, and binding obligation of such Party that is
enforceable against it in accordance with its terms.


 


(c)                                  No Conflict. 
It is not a party to any agreement that would prevent it from granting
the rights granted to the other Party under this Agreement or performing its
obligations under this Agreement.  The execution,
delivery and performance of this Agreement shall not violate, conflict with or
constitute a default under any agreement (including its corporate charter or
other organizational documents) to which it is a party or to which it may be
bound, or to its best knowledge, any applicable Laws or order of any court or
other tribunal.


 


(d)                                  No Debarment. 
In the course of the Development of Products, each Party has not used and shall not use, during the term of this
Agreement, any employee or consultant who has been debarred by any Regulatory
Authority, or,  is the subject of
debarment proceedings by a Regulatory Authority.


 


10.2                        Additional Representations,
Warranties and Covenants of Affymax.  Affymax represents, warrants and
covenants to Collaborator as follows, as of the Effective Date:


 


(a)                                  Regulatory Materials and
Studies.  To the best of Affymax’s knowledge, all
Regulatory Materials Controlled by Affymax in existence as of the Effective
Date and to which Collaborator has rights of use or reference hereunder
(collectively, “Affymax Regulatory Materials”),
including the Regulatory Materials described in Section 4.2(b), as of the
Effective Date have been prepared, maintained and retained in accordance with
applicable Laws.  All preclinical and
clinical studies conducted with respect to Hematide and the Products in
connection with the preparation of the Affymax Regulatory Materials, including
such studies from which the data described in Section 4.1(a) and Section 4.1(b) are
derived, as of the Effective Date have been conducted substantially in
accordance with applicable Laws by persons with appropriate education,
knowledge and experience.  Affymax has
not been debarred and is not subject to debarment, in each case pursuant to Section 306
of the FD&C Act or any similar law or regulation in any jurisdiction
outside the United States.


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


67

















 


(b)                                  Sufficiency of License
Grants; Affymax Patents.  Except as  disclosed in Schedule 10.2 of this Agreement:


 


(i)                                    the Affymax Patents are not subject to
any encumbrance, lien or claim of ownership by any Third Party that is
inconsistent with the rights and (sub)licenses granted to Collaborator
hereunder;


 


(ii)                                no claim or litigation has been brought
or, to the knowledge of Affymax is threatened, by any person or entity alleging
that (A) any of the Affymax Patents in the Licensed Territory is invalid
or unenforceable, or (B) practice of any of the Affymax Technology in the
Licensed Territory infringes or otherwise conflicts or interferes with any
intellectual property or proprietary right of any Third Party;


 


(iii)                            to the knowledge of Affymax, prior to the
Effective Date, no Third Party has infringed or misappropriated any Affymax
Technology, and, as of the Effective Date, there is no actual or threatened
infringement or misappropriation of the Affymax Technology by any Third Party;


 


(iv)                               to the knowledge of Affymax, neither (1) Collaborator’s
exercise of its rights hereunder with respect to the Affymax Technology, nor (2) Affymax’s
or Collaborator’s Development or Commercialization of Hematide or any Product
in the Licensed Territory, will infringe any Patent or other intellectual
property right or other proprietary right of any Third Party;


 


(v)                                   Affymax has the right to grant an exclusive license to Collaborator to each of the
Affymax Patents in the Licensed Territory with a right to sublicense
as provided for in Article 6,


 


(vi)                               this Agreement is consistent with all of
the Third Party License Agreements in all respects and does not conflict with,
violate, breach or otherwise give rise to a default by Affymax under, any term
of each of the Third Party License 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 406 of
the Securities Act of 1933, as amended.


 


68

















 


(vii)                           Affymax has obtained any and all
consents, if any, required from Third Parties for Affymax to enter into this
Agreement and to grant to Collaborator the licenses and other rights provided
herein and has provided a copy of such consents to Collaborator.


 


(viii)                       Affymax owns or possesses adequate right,
title and interest in the Affymax Know-How to grant the license thereto to
Collaborator as provided in Article 6.


 


(ix)                              Exhibit I sets forth all license
agreements existing as of the Effective Date to which Affymax is a party and
under which Affymax has obtained a license from certain Third Parties relating
to inventions necessary or useful for Development or Commercialization of
Products, Peptide, Hematide or [ * ] in the Licensed Territory.


 


(c)                                  Patent Matters in the
Licensed Territory.  With respect to the Licensed Territory, and
as of the Effective Date: (i) All registration, maintenance and renewal
fees due in connection with each Affymax Patent have been paid in a timely
manner, (ii) all documents required to be filed in order to maintain each
Affymax Patent have been filed in a timely manner, (iii) no action has
been taken that would constitute waiver, abandonment or any similar
relinquishment of rights with respect to any Affymax Patent, and (iv) all
relevant prior art known to the entity filing any patent application for any
Affymax Patent has been presented to the relevant patent authority.


 


(d)                                  Supply of Bulk Hematide by
Affymax.  All Bulk Hematide supplied by Affymax to Collaborator
pursuant to this Agreement shall be manufactured, handled and stored by Affymax
or its Third Party contract manufacturer(s) in compliance with all applicable laws and
regulations, including without limitation GMP requirements (to the extent set
forth in this Agreement or the quality agreement to be entered into between the
Parties pursuant to Section 7.8).


 


10.3                        Disclaimer.   Collaborator understands that the Products are
the subject of ongoing clinical research and development and that Affymax
cannot assure the safety or usefulness of Products.  In addition, Affymax makes no warranties
except as set forth in this Agreement concerning the Affymax Technology.


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


69

















 


10.4                        No Other Representations
or Warranties.  EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT,
NO REPRESENTATIONS OR WARRANTIES WHATSOEVER, WHETHER EXPRESS OR IMPLIED,
INCLUDING, WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE, NON-INFRINGEMENT, OR NON-MISAPPROPRIATION OF THIRD PARTY INTELLECTUAL
PROPERTY RIGHTS, IS MADE OR GIVEN BY OR ON BEHALF OF A PARTY.  ALL REPRESENTATIONS AND WARRANTIES, WHETHER
ARISING BY OPERATION OF LAW OR OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED.


 


ARTICLE 11


 


INDEMNIFICATION


 


11.1                        Indemnification by
Affymax.  Affymax shall defend, indemnify, and hold Collaborator
and Collaborator’s officers, directors, employees, and agents (the “Collaborator Indemnitees”) harmless from
and against any and all Third Party claims, suits, proceedings, damages,
expenses (including court costs and reasonable attorneys’ fees and expenses),
and recoveries, including product liability claims (collectively, “Claims”)
to the extent that such Claims arise out of, are based on, or result
from (a) the development, manufacture, storage, handling, use, promotion,
sale, offer for sale, and importation of Products by Affymax or its
sublicensees or Affiliates in the Affymax Territory and/or the Development
activities conducted by or on behalf of Affymax (or its sublicensees or Affiliates in the Affymax
Territory, if any), including without limitation the development activities prior to
or ongoing as of the Effective Date; (b) a breach of any of Affymax’s
representations, warranties, and obligations under the Agreement; or (c) the
willful misconduct or negligent acts of Affymax, its Affiliates, or the
officers, directors, employees, or agents of Affymax or its Affiliates.  The foregoing indemnity obligation shall not
apply if the Collaborator Indemnitees fail to comply with the indemnification
procedures set forth in Section 11.3, or to the extent that any Claim
arises from, is based on, or results from (i) the Development, manufacture, storage,
handling, use, promotion, sale, offer for sale, and importation of Products by
Collaborator or its Affiliates, sublicensees, or distributors; (ii) a
breach of any of Collaborator’s representations, warranties, and obligations
under 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 406 of
the Securities Act of 1933, as amended.


 


70

















 


Agreement; or (iii) the
willful misconduct or negligent acts of Collaborator or its Affiliates, or the
officers, directors, employees, or agents of Collaborator or its Affiliates.


 


11.2                        Indemnification by
Collaborator.  Collaborator shall defend, indemnify, and
hold Affymax and Affymax’s officers, directors, employees, and agents (the “Affymax Indemnitees”) harmless from and
against any and all Claims to the extent that such Claims arise out of, are
based on, or result from (a) the Development, manufacture, storage, handling, use,
promotion, sale, offer for sale, and importation of Products by Collaborator or
its Affiliates, sublicensees, or distributors; (b) a breach of any of
Collaborator’s representations, warranties, and obligations under the
Agreement; or (c) the willful misconduct or negligent acts of Collaborator
or its Affiliates, or the officers, directors, employees, or agents of
Collaborator or its Affiliates.  The
foregoing indemnity obligation shall not apply if the Affymax Indemnitees fail
to comply with the indemnification procedures set forth in Section 11.3,
or to the extent that any Claim arises from, is based on, or results from (i) the
development, manufacture, storage, handling, use, promotion, sale, offer for
sale, and importation of Products by Affymax or its sublicensees or Affiliates
in the Affymax Territory and/or the Development activities conducted by or on
behalf of Affymax (or
its sublicensees or Affiliates in the Affymax Territory, if any),
including without limitation the development activities prior to or ongoing as
of the Effective Date;
(ii) a breach of any of Affymax’s representations, warranties, and
obligations under the Agreement; or (iii) the willful misconduct or
negligent acts of Affymax, its Affiliates, or the officers, directors,
employees, or agents of Affymax or its Affiliates.


 


11.3                        Indemnification
Procedures.  The Party claiming indemnity under this Article 11
(the “Indemnified Party”) shall
give written notice to the Party from whom indemnity is being sought (the “Indemnifying Party”) promptly after
learning of such Claim.  The Indemnified
Party shall provide the Indemnifying Party with reasonable assistance, at the
Indemnifying Party’s expense, in connection with the defense of the Claim for which indemnity is being
sought.  The Indemnified Party may
participate in and monitor such defense with counsel of its own choosing at its
sole expense; provided, however, the Indemnifying Party shall have the right to
assume and conduct the defense of the Claim with counsel of its choice.  The Indemnifying Party shall not settle any
claim without the prior written consent of 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 406 of
the Securities Act of 1933, as amended.


 


71

















 


Indemnified Party, not to
be unreasonably withheld, unless the settlement involves only the payment of
money.  So long as the Indemnifying Party
is actively defending the Claim in good faith, the Indemnified Party shall not
settle any such Claim without the prior written consent of the Indemnifying Party.  If the Indemnifying Party does not assume and
conduct the defense of the Claim as provided above, (a) the Indemnified Party
may defend against, and consent to the entry of any judgment or enter into any
settlement with respect to the claim in any manner the Indemnified Party may
deem reasonably appropriate (and the Indemnified Party need not consult with,
or obtain any consent from, the Indemnifying Party in connection therewith),
and (b) the Indemnifying Party shall remain responsible to indemnify the
Indemnified Party as provided in this Article 11.


 


11.4                        Limitation of
Liability.  NEITHER PARTY SHALL BE LIABLE TO THE
OTHER FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES
ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY
NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. 
NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 11.4 IS
INTENDED TO OR SHALL LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR
OBLIGATIONS OF ANY PARTY UNDER SECTION 11.1 OR 11.2, OR DAMAGES AVAILABLE FOR A PARTY’S BREACH OF SECTION 6.4
OR CONFIDENTIALITY OBLIGATIONS IN ARTICLE 12.


 


11.5                        Insurance. Each Party shall procure and maintain
insurance, including product liability and other appropriate insurance, adequate to cover its
obligations hereunder and which are consistent with normal business practices
of prudent companies similarly situated at all times during which any Product
is being clinically tested in human subjects or commercially distributed or
sold.  It is understood that such
insurance shall not be construed to create a limit of either Party’s liability
with respect to its indemnification obligations under this Article 11.  Each Party shall provide the other with
written evidence of such insurance upon request.  Each Party shall provide the other with
written notice at least thirty (30) days prior to the cancellation, non-renewal
or material change in such insurance or self-insurance which materially
adversely affects the rights of the other Party hereunder.


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


72
















 


ARTICLE 12


 


CONFIDENTIALITY


 


12.1                        Confidentiality.  Except to the extent expressly authorized by this
Agreement or otherwise agreed in writing by the Parties, each Party agrees
that, for the Term and until the later of (i) the tenth anniversary of the
Effective Date, or (ii) five (5) years after the expiration or
termination of the Term, it shall keep confidential and shall not publish or
otherwise disclose and shall not use for any purpose other than as provided for
in this Agreement any Confidential Information furnished to it by the other
Party pursuant to this Agreement except for that portion of such information or
materials that the receiving Party can demonstrate by competent written proof:


 


(a)                                  was already known to the receiving Party
or its Affiliate, other than under an obligation of confidentiality, at the
time of disclosure by the other Party;


 


(b)                                  was generally available to the public or
otherwise part of the public domain at the time of its disclosure to the
receiving Party;


 


(c)                                  became generally available to the public
or otherwise part of the public domain after it disclosure and other than
through any act or omission of the receiving Party in breach of this Agreement;


 


(d)                                  was disclosed to the receiving Party or
its Affiliate by a Third Party without obligations of confidentiality with
respect thereto; or


 


(e)                                  was independently discovered or developed
by the receiving Party or its Affiliate without the aid, application, or use of
Confidential Information of the other Party; provided, however, that this exception shall not
apply to information or materials consisting of data and results generated or
resulting from Development activities with respect to Peptide, [ * ], Hematide
or the Products, which information and materials shall be deemed Confidential
Information of the Party who has developed such information or materials
regardless of whether


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


73

















 


such information and
materials were independently discovered or developed by the receiving Party or
its Affiliate.


 


12.2                        Authorized
Disclosure.  Each Party may disclose Confidential
Information belonging to the other Party to the extent such disclosure is
reasonably necessary in the following situations:


 


(a)                                  filing or prosecuting Patents as
permitted in this Agreement;


 


(b)                                  regulatory filings and other filings with
Governmental Authorities, including filings with the Securities and Exchange
Commission;


 


(c)                                  prosecuting or defending litigation;


 


(d)                                  complying with applicable Laws;


 


(e)                                  disclosure to its employees, agents, and
consultants, and any Third Parties 
(including licensees or sublicensees with which a Party is Developing or
Commercializing Products) only on a need-to-know basis and solely as necessary
in connection with the performance of this Agreement, provided that in each
case the recipient of such Confidential Information must agree to be bound by
similar obligations of confidentiality and non-use at least as equivalent in
scope as those set forth in this Article 12 prior to any such disclosure;
and


 


(f)                                    disclosure of the material financial
terms of this Agreement to any bona fide potential investor, investment banker,
acquiror, merger partner, or other potential financial partner (including, if
applicable, a Third Party Partner that may or does make an equity investment in
Affymax, or a loan to Affymax, in connection with its arrangement with Affymax
for Product in the Affymax Territory); provided that in connection with such
disclosure, the disclosing Party shall use all reasonable efforts to inform
each disclosee of the confidential nature of such Confidential Information and shall cause each recipient of such Confidential
Information to treat such Confidential Information as confidential.


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


74

















 


Notwithstanding the foregoing, in the event a Party is required to make
a disclosure of the other Party’s Confidential Information pursuant to clause (a) through
(d) of this Section 12.2, it shall, except where impracticable, give
reasonable advance notice to the other Party of such disclosure and use best
efforts to secure confidential treatment of such information.  In any event, the Parties agree to take all
reasonable action to avoid disclosure of Confidential Information hereunder.


 


12.3                        Publicity;  Terms of Agreement.


 


(a)                                  The Parties agree that the material terms
of this Agreement are included within the Confidential Information of both
Parties, subject to the special authorized disclosure provisions set forth
below in this Section 12.3.  The
Parties have agreed to make a joint public announcement of the execution of
this Agreement substantially in the form of the press release attached as Exhibit K
on or after the Effective Date.


 


(b)                                  After release of such press release, if
either Party desires to make a public announcement concerning the material
terms of this Agreement, such Party shall give reasonable prior advance notice
of the proposed text of such announcement to the other Party for its prior
review and approval (except as otherwise provided herein), such approval not to
be unreasonably withheld.  A Party
commenting on such a proposed press release shall provide its comments, if any,
within three (3) business days after receiving the press release for
review.  Affymax shall have the right to
make a press release announcing the achievement of each milestone under this
Agreement as it is achieved, and the achievements of Regulatory Approvals in
the Licensed Territory as they occur, subject only to the review procedure set
forth in the preceding sentence.  In
relation to Collaborator’s review of such an announcement, Collaborator may
make specific, reasonable comments on such proposed press release within the
prescribed time for commentary, but shall not withhold its consent to
disclosure of the information that the relevant milestone has been achieved and
triggered a payment hereunder.  Neither
Party shall be required to seek the permission of the other Party to repeat any
information regarding the terms of this Agreement that has already been publicly
disclosed by such Party, or by the other Party, in accordance with this Section 12.3.


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


75

















 


(c)                                  The Parties acknowledge that Affymax may be obligated to file a copy of this
Agreement with the U.S. Securities and Exchange Commission (the “SEC”). 
Affymax shall be entitled to make such a required filing, provided that
it requests confidential treatment of certain commercial terms and sensitive
technical terms hereof to the extent such confidential treatment is reasonably
available to Affymax.  In the event
of any such filing, Affymax shall provide Collaborator with a copy of the Agreement marked to
show provisions for which Affymax intends to seek confidential treatment and
shall reasonably consider and incorporate Collaborator’s comments thereon to the extent consistent
with the legal requirements governing redaction of information from material
agreements that must be publicly filed.  Collaborator shall promptly provide any such
comments.  Collaborator recognizes that U.S. laws and SEC
policies and regulations to which Affymax is and may become subject may require Affymax to publicly disclose certain terms of
this Agreement that Collaborator may prefer not be disclosed, and that Affymax is, after
completing the above mentioned procedures, entitled hereunder to make such required disclosures to the extent
legally required.


 


12.4                        Publications.  Neither Party may
publish peer reviewed
manuscripts, or give other forms of public disclosure such as abstracts and
presentations, of results of studies carried out under this Agreement with
respect to the Licensed Territory, without the opportunity for prior review by the other
Party.  Each Party shall provide the other Party the opportunity to review and comment on
any proposed manuscripts or presentations which relate to any Product at least
thirty (30) days prior to their intended submission for publication or
presentation.  Each Party shall consider the comments of the other Party and shall remove any and all of the other Party’s
Confidential
Information at the request of such other Party.  A Party seeking
publications shall
provide the other Party a
copy of the manuscript at the time of the submission.  Neither Party shall have the right to publish or
present the other Party’s Confidential
Information without the other Party’s prior written consent, except as
expressly permitted in this Agreement.  
This Section 12.4 shall not relate to any publications or other
forms of public disclosure sought by any Third Party Partner with respect to
the Product.


 


12.5
Injunction.   Each Party shall be entitled, in addition
to any other right or remedy it may have, at Law or in equity, to seek an
injunction in any court of competent jurisdiction,


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


76

















 


enjoining or
restraining the other Party and/or its Affiliates from any violation or
threatened violation of this Article 12.


 


ARTICLE 13


 


TERM AND TERMINATION


 


13.1                        Term. 
This Agreement shall become effective on the Effective Date and, unless
earlier terminated pursuant to this Article 13, shall remain in effect  in the Licensed Territory until the
expiration of all of Collaborator’s payment obligations under Article 8.  Following such expiration, Collaborator shall
have a fully paid non-exclusive license under the Affymax Technology to make, have made, use, sell and import Hematide, Peptide, [ * ]
and/or Product in the
Licensed Territory, under such trademark as Collaborator has been using in
collaboration with the Product, or any other trademark.  In addition, in the event Collaborator
desires to continue to purchase Bulk Hematide from Affymax, it shall so notify
Affymax no later than six  6) months
prior to the expiration of this Agreement, and thereafter Affymax shall either (a) continue
to supply Bulk Hematide at a cost equal to the Manufacturing Cost plus [ * ] for a period to be negotiated by the Parties, or (b) permit
Collaborator to manufacture itself, or on its behalf through a contract
supplier, Bulk Hematide, and in such event grant to Collaborator a
non-exclusive royalty-free license, under Affymax Technology related to manufacture of Bulk Hematide,
and otherwise assist Collaborator to enable it to obtain continuous supply of
Bulk Hematide, including without limitation, providing relevant documents and using diligent efforts to encourage or cause Affymax’s
then-current Third Party contract manufacturers of Bulk Hematide to manufacture
and supply to Collaborator such Bulk Hematide directly. Upon request of Collaborator,
Affymax shall provide to Collaborator reasonable access to Affymax’s
manufacturing personnel to facilitate the foregoing efforts on terms to be
agreed upon by the Parties.


 


13.2                        Early
Termination.


 


(a)                                  Withdrawal
by Collaborator.  Collaborator shall have the right to
terminate this Agreement, for any or no reason, in its entirety, upon six (6) months’
written


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


77

















 


notice to Affymax;
provided that any such termination shall not be effective prior to the second
anniversary of the Effective Date; and further provided that Collaborator
shall have the right to terminate this Agreement before the end of such two (2) year
period if Product Development efforts by or on behalf of Collaborator are
terminated entirely for patient safety concerns or pursuant to a requirement
imposed by Regulatory Authorities in the Licensed Territory or by the external
monitoring board.  If
Collaborator terminates this Agreement pursuant to this Section 13.2(a),
then:


 


(i)                                    Collaborator shall not, during such six (6) month
notice period, take any action that could adversely affect or impair the
further Development and
Commercialization of Products; and


 


(ii)                                the Joint Committee shall coordinate the
wind-down of Collaborator’s efforts under this Agreement; and


 


(iii)                            Collaborator shall continue to be
responsible for any payments that become due to Affymax pursuant to this
Agreement during such six  (6) month
notice period.


 


(b)                                  Termination for
Breach.  Affymax shall have the right to terminate this
Agreement upon written notice to Collaborator if Collaborator, after receiving
written notice identifying such material breach by Collaborator, fails to cure
such material breach
within sixty (60) days from the date of such notice (or within ten (10) business days notice in the event such material breach is solely based upon Collaborator’s
failure to pay any amounts due Affymax hereunder).  Collaborator shall have the right to
terminate this Agreement upon written notice to Affymax if Affymax, after
receiving written notice identifying a material breach by Affymax of its obligations
under this Agreement, fails to cure such material breach within sixty (60) days from the
date of such notice.  For clarity, if a
Party elects not to exercise its rights to terminate this Agreement pursuant to
this Section 13.2(b) for the other Party’s uncured material breach, but
instead elects to allow this Agreement to continue in effect, then the
breaching Party shall continue to be liable to the other Party for any breach
of representations, warranties, obligations or agreements made in this
Agreement by such breaching Party, and the non-breaching Party


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


78

















 


shall be entitled to
pursue legal and equitable remedies arising from such breach that are available
to it.


 


13.3                        Effect of Termination of
the Agreement. Upon
termination by Affymax of the Agreement under Section 13.2(b), or upon
termination by Collaborator under Section 13.2(a), the following shall
apply (in addition to any other rights and obligations under Section 13.4,
13.5 or 13.6 or otherwise under this Agreement with respect to such termination):


 


(a)                                  Regulatory Materials. 
To the extent permitted by applicable Law, Collaborator shall transfer
and assign to Affymax all Regulatory Materials and Regulatory Approvals for
Product in the Licensed Territory that are Controlled by Collaborator.


 


(b)                                  Collaborator
License.  Collaborator hereby grants to Affymax, effective only
in such event, a non-exclusive, worldwide, fully-paid, royalty-free license,
with the right to grant multiple tiers of sublicenses, under the Collaborator
Technology existing as of the date of termination to develop, make, have made, use, sell, offer for
sale, and import Bulk Hematide, the [ * ] and any Products.


 


(c)                                  Transition Assistance. 
Collaborator shall, for a reasonable period of time, provide such assistance, at no cost to
Affymax, to transfer and/or transition to Affymax all other technology or
know-how, or then-existing commercial arrangements, that is, or are, reasonably
necessary or useful for Affymax to commence or continue Developing, conducting
Finished Manufacturing of or Commercializing Products in the Licensed
Territory, to the
extent Collaborator is then performing or having performed such activities,
including without limitation transferring, upon request of Affymax, any
agreements or arrangements with Third-Party suppliers or vendors to supply or
sell Products in the Licensed Territory, to the extent practicable. If any such contract between
Collaborator and a Third Party for the supply of Bulk Hematide or Finished
Product for the Licensed Territory is not assignable to Affymax, then
Collaborator shall reasonably cooperate with Affymax to arrange to continue to
obtain such supply from such entity, and Collaborator shall supply such Bulk
Hematide or Finished Product, as applicable, to Affymax, at a cost that equals
[ * ] of Collaborator’s cost (calculated in a manner consistent with the definition
of Affymax’s
Manufacturing Cost) for a reasonable period.


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


79

















 


In addition, to the
extent that Collaborator or its Affiliate is then manufacturing Bulk Hematide
and/or Finished Products for the Licensed Territory, Collaborator shall
continue to manufacture, and shall supply to Affymax, at a cost that equals [ * ] of Collaborator’s costs (calculated in a manner
consistent with the definition of Affymax’s Manufacturing Cost), such Bulk
Hematide and/or Finished Products for Affymax’s use in the Licensed Territory
for a reasonable period in order to permit Affymax to establish sufficient manufacturing capacity for Bulk
Hematide and/or Finished Product for the Licensed Territory, in addition to
that which it had in place for its use in the Affymax Territory.  Such period shall be no more than twelve (12) months unless otherwise agreed by the
Parties.


 


(d)                                  Remaining Inventories. 
Affymax shall have the right to purchase from Collaborator all of the
inventory of Bulk Hematide and/or Finished Product held by Collaborator as of
the effective date of termination of this Agreement at a price equal to
Collaborator’s [ * ] to acquire or manufacture such inventory.  Affymax shall notify Collaborator within
thirty (30) days after the date of termination 
of the Agreement whether Affymax elects to exercise such right.  If Affymax does not exercise such right, then
Collaborator shall have the right to sell in the Licensed Territory any such
remaining inventory over a period of no greater than six (6) months after
the effective date of termination of this Agreement.


 


For clarity, upon any termination of this
Agreement under Section 13.2, the licenses granted to Collaborator under this Agreement shall terminate.


 


13.4                        Other Remedies. 
Termination or expiration of this Agreement for any reason shall not
release any Party from any liability or obligation that already has accrued
prior to such expiration or termination, nor affect the survival of any
provision hereof to the extent it is expressly stated to survive such
termination.  Termination or expiration
of this Agreement for any reason shall not constitute a waiver or release of,
or otherwise be deemed to prejudice or adversely affect, any rights, remedies
or claims, whether for damages or otherwise, that a Party may have hereunder or
that may arise out of or in connection with such termination or expiration.


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


80

















 


13.5                        Rights in Bankruptcy.  All rights and licenses granted under or pursuant to
this Agreement by Affymax are, and shall otherwise be deemed to be, for
purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of
right to “intellectual property” as defined under Section 101 of the U.S.
Bankruptcy Code.  The Parties agree that
Collaborator, as licensee of such rights under this Agreement, shall retain and
may fully exercise all of its rights and elections under the U.S. Bankruptcy Code.  The Parties further agree that, in the event
of the commencement of a bankruptcy proceeding by or against Affymax under the
U.S. Bankruptcy Code, Collaborator shall be entitled to a complete duplicate of
(or complete access to, as appropriate) any such intellectual property and all
embodiments of such intellectual property, which, if not already in
Collaborator’s possession, shall be promptly delivered to it (a) upon any
such commencement of a bankruptcy proceeding upon Collaborator’s written
request therefor, unless Affymax elects to continue to perform all of its
obligations under this Agreement or (b) if not delivered under clause (a),
following the rejection of this Agreement by Affymax upon written request
therefor by Collaborator.


 


13.6                        Survival. 
The following provisions shall survive any expiration or termination of
this Agreement for the period of time specified: Articles 1, 11 (to the extent
relevant to claims arising from actions or omissions occurring during the
Term), 12, 14 (to the extent relevant to disputes arising during the Term) and
15, and Sections 7.6, 8.7, 8.8, 9.1, 9.2, 9.3(c) (except for the proviso
of the seventh sentence which relates to the limitation of Collaborator’s right
to grant licenses under the Joint Patents, which shall survive for two (2) years
after any termination by Collaborator under Section 13.2(a) prior to First
Commercial Sale of Product in the Licensed Territory for reasons unrelated to
patient safety concerns, and which otherwise shall not survive), 10.3, 10.4,
13.3, 13.4, 13.5 and 13.6.


 


ARTICLE 14


 


DISPUTE RESOLUTION


 


14.1                        English Language;
Governing Law. This Agreement was prepared in the English language, which language
shall govern the interpretation of, and any dispute regarding,


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


81

















 


the terms of this
Agreement.  This Agreement and all
disputes arising out of or related to this Agreement or any breach hereof shall
be governed by and construed under the laws of the State of New York, without giving effect to any choice of
law principles that would require the application of the laws of a different
state.  Subject to Sections 14.2 and
14.3, any claim or controversy of whatever nature arising out of or relating to
this Agreement or any breach hereof shall be brought exclusively in a court of
competent jurisdiction, federal or state, located in San Francisco, California, and in no other jurisdiction.  Each Party hereby consents to personal
jurisdiction and venue in, and agrees to service of process issued or
authorized by, such court. 
Notwithstanding the foregoing, either Party may seek injunctive relief
in any court in any jurisdiction where appropriate.


 


14.2                        Disputes. 
The Parties recognize that disputes as to certain matters may from time
to time arise during the Term which relate to either Party’s rights and/or obligations
hereunder.  It is the objective of the
Parties to establish procedures to facilitate the resolution of disputes
arising under this Agreement in an expedient manner by mutual cooperation and
without resort to litigation.  To
accomplish this objective, the Parties agree to follow the procedures set forth
in this Section 14.2 to resolve any controversy or claim arising out of,
relating to or in connection with any provision of this Agreement (other than a
dispute addressed in Section 14.3), if and when a dispute arises under
this Agreement.


 


(a)                                  Referred From Joint
Committee.  With respect to disputes arising from the
Joint Committee pursuant to Section 2.4(a), if the Joint Committee is
unable to resolve any dispute within ten (10) business days after such dispute is submitted to
it, either Party may, by written notice to the other Party, have such dispute
referred to the senior executive officers for each Party for attempted
resolution by good faith negotiations within thirty (30) days after such notice
is received.  If the senior executive
officers designated by the Parties are not able to resolve such dispute within
such thirty (30) day period, either Party may at any
time thereafter pursue any legal or equitable remedy available to it in
accordance with Section 14.1.


 


(b)                                  Arising Between the
Parties.  With respect to all disputes arising between the
Parties and not from the Joint Committee, including, without limitation, any
alleged


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


82
















 


failure to perform, or
breach, of this Agreement, or any issue relating to the interpretation or
application of this Agreement, if the Parties are unable to resolve such
dispute within sixty (60) days after such dispute is first identified by either
Party in writing to the other, the Parties shall refer such dispute to the
senior executive officers for each Party for attempted resolution by good faith
negotiations within thirty (30) days after such notice is received.  If the senior executive officers designated
by [ * ] are not able to resolve such
dispute within such thirty (30) day period, either Party may at any time
thereafter pursue any legal or equitable remedy available to it in accordance
with Section 14.1.


 


14.3        Patent and Trademark Dispute Resolution.   Any dispute, controversy or claim between the
Parties relating to the scope, validity, enforceability or infringement of any Patents covering the manufacture, use or
sale of any Product or of any trademark rights relating to any Product shall be
submitted to a court of competent jurisdiction in the Licensed Territory in
which such Patents or
trademark rights were granted or arose.


 


ARTICLE 15


 


MISCELLANEOUS


 


15.1        Entire Agreement; Amendment. 
This Agreement, including the Exhibits hereto, sets forth the complete,
final and exclusive agreement and all the covenants, promises, agreements,
warranties, representations, conditions and understandings between the Parties
hereto with respect to the subject matter hereof and supersedes, as of the
Effective Date, all prior agreements and understandings between the Parties
with respect to the subject matter hereof, including, without limitation, the
Mutual Confidential Disclosure Agreement between the Parties dated September 30,
2005.  There are no covenants, promises,
agreements, warranties, representations, conditions or understandings, either
oral or written, between the Parties other than as are set forth herein and
therein.  No subsequent alteration,
amendment, change or addition to this Agreement shall be binding upon the
Parties unless reduced to writing and signed by an authorized officer of each
Party.


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


83

















 


15.2        Force Majeure. 
Both Parties shall be excused from the performance of their obligations
under this Agreement to the extent that such performance is prevented by force
majeure and the nonperforming Party promptly provides notice of the prevention
to the other Party.  Such excuse shall be
continued so long as the condition constituting force majeure continues and the
nonperforming Party takes reasonable efforts to remove the condition.  For purposes of this Agreement, force majeure
shall include conditions beyond the control of the Parties, including without
limitation, an act of God, war, civil commotion, terrorist act, labor strike or
lock-out, epidemic, failure or default of public utilities or common carriers,
destruction of production facilities or materials by fire, earthquake, storm or
like catastrophe, and failure of plant or machinery (provided that such failure
could not have been prevented by the exercise of skill, diligence, and prudence
that would be reasonably and ordinarily expected from a skilled and experienced
person engaged in the same type of undertaking under the same or similar
circumstances).  Notwithstanding the
foregoing, a Party shall not be excused from making payments owed hereunder
because of a force majeure affecting such Party.


 


15.3        Notices.  Any notice required or permitted to be given under
this Agreement shall be in writing, shall specifically refer to this Agreement,
and shall be addressed to the appropriate Party at the address specified below
or such other address as may be specified by such Party in writing in
accordance with this Section 15.3, and shall be deemed to have been given
for all purposes (a) when received, if hand-delivered or sent by a
reputable overnight delivery service, or (b) five (5) business days
after mailing, if mailed by first class certified or registered mail, postage
prepaid, return receipt requested.


 


	
  If to Affymax:

  	
  Affymax, Inc.

  
	
   

  	
  4001 Miranda Avenue

  
	
   

  	
  Palo Alto, California 94306

  
	
   

  	
  Attn: Chief
  Executive Officer

  



 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


84

















 


	
  With a copy to:

  	
  Barbara A. Kosacz, Esq.

  
	
   

  	
  Cooley Godward LLP

  
	
   

  	
  5 Palo Alto Square

  
	
   

  	
  3000 El Camino Real

  
	
   

  	
  Palo Alto, CA 94306

  
	
   

  	
   

  
	
  If to Collaborator:

  	
  Takeda Pharmaceutical
  Company Limited

  
	
   

  	
  1-1,
  Doshomachi 4-chome, Chuo-ku,

  
	
   

  	
  Osaka, 540-8645, Japan

  
	
   

  	
  Attn: General
  Manager, Global Licensing and Business Development

  



 


15.4        No Strict Construction;
Headings.  This Agreement has been prepared jointly
and shall not be strictly construed against either Party.  Ambiguities, if any, in this Agreement shall
not be construed against any Party, irrespective of which Party may be deemed
to have authored the ambiguous provision. 
The headings of each Article and Section in this Agreement
have been inserted for convenience of reference only and are not intended to
limit or expand on the meaning of the language contained in the particular Article or
Section.


 


15.5        Assignment. 
Neither Party may assign or transfer this Agreement or any rights or
obligations hereunder without the prior written consent of the other, except
that a Party may make such an assignment without the other Party’s consent to
Affiliates or to a successor to substantially all of the business of such Party
in the field to which this Agreement relates, whether in a merger, sale of
stock, sale of assets or other transaction. 
Notwithstanding anything to the contrary in Article 1, in the event
of such transaction, however, intellectual property rights of the acquiring
party to such transaction (if other than one of the Parties to this Agreement)
shall not be included in the technology licensed to the other Party hereunder
to the extent held by such acquiror prior to such transaction, or to the extent
such technology is developed outside the scope of activities conducted with
respect to the Peptide, [ * ], Hematide, Alternative ESA, Backup
Product or
Product.  Any permitted successor or
assignee of rights and/or obligations hereunder


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


85

















 


shall, in writing to the
other Party, expressly assume performance of such rights and/or
obligations.  The Affymax Technology and
the Collaborator Technology shall exclude any intellectual property held or
developed by a permitted successor and not in connection with Products.  Any permitted assignment shall be binding on
the successors of the assigning Party. 
Any assignment or attempted assignment by either Party in violation of
the terms of this Section 15.5 shall be null, void and of no legal effect.


 


15.6        Performance by Affiliates. 
Each Party may discharge any obligations and exercise any right
hereunder through any of its Affiliates. 
Each Party hereby guarantees the performance by its Affiliates of such
Party’s obligations under this Agreement, and shall cause its Affiliates to
comply with the provisions of this Agreement in connection with such
performance.  Any breach by a Party’s
Affiliate of any of such Party’s obligations under this Agreement shall be deemed
a breach by such Party, and the other Party may proceed directly against such
Party without any obligation to first proceed against such Party’s Affiliate.


 


15.7        Further Actions.   Each Party agrees to execute, acknowledge and
deliver such further instruments, and to do all such other acts, as may be
necessary or appropriate in order to carry out the purposes and intent of this
Agreement.


 


15.8        Severability. 
If any one or more of the provisions of this Agreement is held to be
invalid or unenforceable by any court of competent jurisdiction from which no
appeal can be or is taken, the provision shall be considered severed from this
Agreement and shall not serve to invalidate any remaining provisions
hereof.  The Parties shall make a good
faith effort to replace any invalid or unenforceable provision with a valid and
enforceable one such that the objectives contemplated by the Parties when
entering this Agreement may be realized.


 


15.9        No Waiver. 
Any delay in enforcing a Party’s rights under this Agreement or any
waiver as to a particular default or other matter shall not constitute a waiver
of such Party’s rights to the future enforcement of its rights under this
Agreement, except with respect to an express written and signed waiver relating
to a particular matter for a particular period of time.


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


86

















 


15.10      Independent Contractors.  Each Party shall act solely as an independent
contractor, and nothing in this Agreement shall be construed to give either
Party the power or authority to act for, bind, or commit the other Party in any
way.  Nothing herein shall be construed
to create the relationship of partners, principal and agent, or joint-venture
partners between the Parties.


 


15.11      Counterparts. 
This Agreement may be executed in one (1) or more counterparts,
each of which shall be deemed an original, but all of which together shall
constitute one and the same instrument. 
This Agreement shall be binding upon the delivery by each Party of an
executed signature page to the other Party by facsimile transmission.  If signature pages are so delivered by
facsimile transmission, each Party shall also immediately deliver an executed
original counterpart of this Agreement to the other Party by courier delivery service.


 


{Signature page follows.}


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


87

















 


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


 


	
  TAKEDA PHARMACEUTICAL
  COMPANY LIMITED

  	
   

  	
  AFFYMAX, INC.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ Makato
  Yamaoka

  	
   

  	
  By:

  	
  /s/ Arlene
  Morris

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Name: Makoto Yamaoka

  	
   

  	
  Name:  Arlene Morris

  
	
   

  	
   

  	
   

  
	
  Title: Managing
  Director

  	
   

  	
  Title:   President & CEO

  
	
   

  	
   

  	
   

  
	
           General Manager

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
           Pharmaceutical Marketing
  Division

  	
   

  	
   

  



 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


88

















 


 


EXHIBIT
A


 


AFFYMAX
HOUSE MARKS


 


	
  AFFYMAX

  	
   

  	
  United

  States

  	
   

  	
  Registration

  No. 1,855,403

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (black/white)


  	
   

  	
  United States

  	
   

  	
  Serial No. 76/468,006

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  (color)


  	
   

  	
  United States

  	
   

  	
  Serial No. 76/468,005

  



 






[ * ] = 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 406 of the
Securities Act of 1933, as amended.


 

















 


EXHIBIT
B


 


AFFYMAX
PATENTS


 


To the extent the following table lists
patents and patent applications filed or issued in the United States, Affymax
Patents shall include any equivalent applications and patents that are or will be filed
with patent authorities in the Licensed Territory (i.e., those applications and
patents that claim priority to such United States applications or to the
applications from which such United States patents issued).


 


Patents for Japanese Licensee


 


[ * ]


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 

















 


EXHIBIT
C


 


[ * ] STRUCTURE


 


[
* ]


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 

















 


EXHIBIT
D


 


PEPTIDE
STRUCTURE


 


[
* ]


 






[ * ] = 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 406 of the
Securities Act of 1933, as amended.


 
















 


EXHIBIT  E


 


REAGENT


 


[
* ]


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 

















 


EXHIBIT
F


 


JOINT
COMMITTEE MEMBERS AND PROJECT COORDINATORS


 


For
Affymax:


 


Joint Committee Members:


 


Anne-Marie Duliege, M.D.,
V.P. Clinical and Regulatory Affairs


 


Doug Cole. V.P., Ph.D.,
Development


 


Chris Dammann, V.P.
Business Development


 


Project
Coordinator:


 


Kerstin Leuther,
Ph.D., Director Project Management


 


For
Takeda:


 


Joint
Committee Members:


 


Hisao Nakajima,
MPDRAP Franchise II Project Leader, Strategic Product Planning Department Mitsuhiro
Okamoto, Senior Manager, Japan Development Center, Pharmaceutical Development
Division


 


Hisayoshi Iwakiri,
Group Manager, Oncology Group, Ethical Product Marketing Department,
Pharmaceutical Marketing Division


 


Project
Coordinator:


 


Toshikazu Ban, Senior
Director, Global Licensing, Global Licensing and Business Development


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 

















 


EXHIBIT
G


[ * ]


 


[ * ]


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 

















 


EXHIBIT
H   DEVELOPMENT PLAN


 


[ * ]


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 

















 


EXHIBIT
I


 


[ * ]


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 

















 


EXHIBIT
J


 


AFFYMAX,
INC.


 


SERIES E
PREFERRED STOCK PURCHASE AGREEMENT


 


February 
        , 2006


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 

















 


AFFYMAX,
INC.


 


SERIES E
PREFERRED STOCK PURCHASE AGREEMENT


 


THIS SERIES E PREFERRED STOCK PURCHASE AGREEMENT (the “Agreement”)
is made and entered into as of February       ,
2006, by and among AFFYMAX, INC., a
Delaware corporation (the “Company”),
and each of those persons and entities, severally and not jointly, whose names
are set forth on the Schedule of Investors attached hereto as Exhibit A (which persons and entities
are hereinafter collectively referred to as “Investors”
and each individually as an “Investor”).


 


RECITALS


 


WHEREAS, Investors desire to purchase an aggregate of
2,120,329 shares of the Company’s Series E Preferred Stock (the “Shares”) on the terms and conditions set forth herein; and


 


WHEREAS, the Company desires to issue and sell the Shares to
Investors on the terms and conditions set forth herein.


 


NOW, THEREFORE, in consideration of the representations, warranties,
covenants and agreements set forth herein, and for other good and valuable
consideration the receipt and sufficiency of which are hereby acknowledged, the
parties hereto hereby agree as follows:


 


1.                                      PURCHASE AND SALE OF
SERIES E PREFERRED STOCK.


 


1.1                               Sale and Issuance of Series E
Preferred Stock.


 


(a)                                  The Company shall adopt and file with the
Secretary of State of Delaware on or before the Closing (as defined below), the
Amended and Restated Certificate of Incorporation of the Company substantially
in the form attached hereto as Exhibit B
(the “Restated Charter”).


 


(b)                                  Subject to the terms and conditions of
this Agreement, each Investor agrees, severally and not jointly, to purchase at
the Closing, and the Company agrees to sell and issue to each Investor at the
Closing, that number of shares of the Company’s Series E Preferred Stock
set forth opposite each Investor’s name on Exhibit A
hereto for the purchase price of $4.7162 per share.


 


1.2                               Closing.


 


(a)                                  The purchase and sale of the Series E
Preferred Stock and the consummation of the other transactions contemplated by
the Financing Agreements (as defined below) (the “Closing”) shall take place at the offices of Cooley Godward
LLP, 3175 Hanover Street, Palo Alto, CA, 94304-1130, at such date, time and
place as the Company and Investors acquiring in the aggregate more than
one-half (1/2) of the shares of the Series E Preferred Stock 


 






[ * ] = 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 406 of the
Securities Act of 1933, as amended.


 


1

















 


sold pursuant hereto
mutually agree upon orally or in writing (such date is hereinafter referred to
as the “Closing Date”).


 


(b)                                  At the Closing, the Company shall deliver
to each Investor a certificate representing the shares of Series E
Preferred Stock that such Investor is purchasing hereunder as shown on Exhibit A against payment to the Company
by such Investor of the full purchase price therefor by check, wire transfer or
any combination thereof.


 


2.                                      REPRESENTATIONS AND
WARRANTIES OF THE COMPANY.


 


Except as set forth on
the Schedule of Exceptions (the “Schedule of
Exceptions”) which specifically identifies the relevant Section hereof
(and which shall apply to any other sections in this Section 2 where such
disclosure is relevant, provided that such relevance is reasonably clear (a
listing of a party, contract, agreement, document or instrument in and of
itself without any reasonably responsive textual description is not relevance
that is reasonably clear) from the disclosure in the Schedule of Exceptions)
furnished to each Investor prior to execution hereof and attached hereto as Schedule
A (which exceptions shall be deemed to be representations and warranties as
if made hereunder), the Company hereby represents, warrants, and (as
applicable) covenants to each of the Investors, as follows:


 


2.1                               Organization, Good Standing and
Qualification.  The Company is a corporation duly organized,
validly existing and in good standing under the laws of the State of Delaware
and has all requisite corporate power and authority to own and operate its
properties and assets, to carry out the transactions contemplated by the
Financing Agreements, and to carry on its business as presently conducted.  The Company is duly qualified to transact
business as a foreign corporation and is in good standing in each jurisdiction
in which such failure to so qualify could reasonably be expected to have a
Material Adverse Effect (as defined in Section 2.5 below) on the Company.


 


2.2                               Capitalization and Voting Rights.


 


(a)                                  The authorized capital stock of the
Company, immediately prior to the Closing, consists of:


 


(i) Preferred Stock. 
Thirty-Six Million Seven Hundred Twenty-Nine Thousand Nine Hundred
Twenty-One (36,729,921) shares of Preferred Stock, $0.0001 par value (the “Preferred Stock”), of which (i) Two
Million Three Hundred Thousand (2,300,000) shares have been designated Series A
Preferred Stock, all of which are issued and outstanding, (ii) Five
Million (5,000,000) shares have been designated Series B Preferred Stock,
all of which are issued and outstanding, (iii) Ten Million Six Hundred
Nine Thousand Five Hundred Ninety-Two (10,609,592) shares have been designated Series C
Preferred Stock, Ten Million Six Hundred One Thousand Six Hundred
Forty-One  (10,601,641) shares of which
are issued and outstanding, (iv) Sixteen Million Seven Hundred Thousand
(16,700,000) shares have been designated Series D Preferred Stock, Fifteen
Million Nine Hundred Two Thousand Four Hundred Sixty-Four (15,902,464) shares
of which are issued and outstanding and (v) Two Million One Hundred 


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


2

















 


Twenty-Thousand Three Hundred Twenty-Nine (2,120,329)
shares of Series E Preferred Stock, none of which are issued and
outstanding.  The rights, privileges and
preferences of the Preferred Stock will be as stated in the Restated Charter.


 


(ii)                                Common Stock; Options;
Reserved Shares.  Fifty Million Seven Hundred Fifty Thousand
(50,750,000) shares of common stock, $0.0001 par value (the “Common Stock”), of which One Million Three
Hundred Thirty-One Thousand One Hundred Seventy-One (1,331,171) shares are
issued and outstanding.  Under the
Company’s 2001 Stock Option/Stock Issuance Plan (the “Plan”), (i) options to purchase Four
Million Eight Hundred Eighty-Five Thousand Nine Hundred Eighty (4,885,980)
shares have been granted and are currently outstanding, and (ii) Nine
Thousand Four Hundred Seventy-Two (9,472) shares of Common Stock remain
available for future issuance to officers, directors, employees and consultants
of the Company.


 


(b)                                  All issued and outstanding shares of the
Company’s Common Stock and Preferred Stock (i) have been duly authorized
and validly issued and are fully paid and nonassessable, and (ii) were
issued in compliance with all applicable state and federal laws concerning the
issuance of securities.


 


(c)                                  Except for (i) the conversion
privileges of the Preferred Stock, (ii) the rights provided in the
Restated Charter, the Amended and Restated Investors’ Rights Agreement in the
form attached hereto as Exhibit C
(the “Investors’ Rights Agreement”) and the
Amended and Restated Right of First Refusal and Co-Sale Agreement in the form
attached hereto as Exhibit D
(the “Co-Sale Agreement”), (iii) warrants
exercisable for 7,951 shares of Series C Preferred Stock at an exercise
price of $3.773 per share, (iv) warrants exercisable for 1,532,405 shares
of Common Stock at an exercise price of $4.25 per share pursuant to that
certain Warrant Purchase Agreement, dated July 11, 2005, and (v) warrants
exercisable for 220,316 shares of Common Stock at an exercise price of $1.14
per share to Montgomery & Co., 
there are no options, warrants, calls, rights (including conversion or
preemptive rights), commitments or agreements of any character to which the
Company is a party or by which it is bound obligating the Company to issue,
deliver, sell, repurchase or redeem, or cause to be issued, delivered, sold,
repurchased or redeemed, any shares of capital stock of the Company or
obligating the Company to grant, extend, accelerate the vesting of, change the
price of, or otherwise amend or enter into such option, warrant, call, right,
commitment or agreement.  Other than the
Amended and Restated Voting Agreement in the form attached hereto as Exhibit E (the “Voting Agreement”
and together with this Agreement, the Investors’ Rights Agreement and the
Co-Sale Agreement, the “Financing Agreements”),
and except as set forth in the Restated Charter, there are no contracts,
commitments or agreements relating to the voting of the Company’s capital
stock: (i) between or among the Company and any of its security holders, (ii) by
a director of the Company and (iii) to the knowledge of the Company,
between or among any of the Company’s security holders.


 


2.3                               Authorization. 
The Company has all requisite corporate power and authority to enter
into the Financing Agreements to which it is a party and to consummate the
transactions contemplated hereby and thereby, as the case may be.  All corporate action on the part of 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 406 of
the Securities Act of 1933, as amended.


 


3

















 


Company and its officers,
directors and stockholders necessary for the authorization, execution and delivery
of the Financing Agreements, the performance of all obligations of the Company
hereunder and thereunder, the filing of the Restated Charter, and the
authorization, sale and issuance (or reservation for issuance) of the Series E
Preferred Stock being sold hereunder and the Common Stock issuable upon
conversion of the Shares (the “Conversion
Shares”), has been taken or will be taken prior to the Closing.  The Financing Agreements and all other
agreements contemplated hereby or thereby to which the Company is a party, upon
signing and delivery will constitute valid and legally binding obligations of
the Company, enforceable in accordance with their respective terms, except (i) as
limited by applicable bankruptcy, insolvency, reorganization, moratorium and
other laws of general application affecting enforcement of creditors’ rights
generally, (ii) as limited by laws relating to the availability of
specific performance, injunctive relief or other equitable remedies and (iii) to
the extent that the enforceability of the indemnification provisions contained
in the Investors’ Rights Agreement may be limited by applicable federal or
state securities laws.


 


2.4                               Valid Issuance of Series E
Preferred Stock.  The Series E Preferred Stock that is
being purchased by the Investors hereunder, when issued, sold and delivered in
compliance with the terms of this Agreement and the Restated Charter, will be
duly and validly issued, fully paid and nonassessable and will be free of any
Encumbrances (as defined below) other than any Encumbrances created by or
imposed upon the holders thereof and will be free of restrictions on transfer,
other than restrictions on transfer under this Agreement, the Investors’ Rights
Agreement, the Co-Sale Agreement, and applicable state and federal securities
laws.  The Conversion Shares have been
duly and validly reserved for issuance and, upon issuance in accordance with
the terms of the Restated Charter, will be duly and validly issued, fully paid
and nonassessable will be free of any Encumbrances other than any liens or
Encumbrances created by or imposed upon the holders thereof and will be free of
restrictions on transfer, other than restrictions on transfer under this
Agreement, the Investors’ Rights Agreement, the Co-Sale Agreement, and applicable
state and federal securities laws.  “Encumbrance” means any claim, lien, pledge,
option, charge, easement, security interest, deed of trust, mortgage,
right-of-way, encroachment, building or use restriction, conditional sales
agreement, encumbrance or other similar right of any third parties, whether
voluntarily incurred or arising by operation of law, and includes any agreement
to give any of the foregoing in the future, and any contingent sale or other
title retention agreement or lease in the nature thereof other than (i) liens
for current taxes, assessments, or governmental charges, or levies on property
not yet due and payable and (ii) such imperfections of title, liens and
easements as do not and will not materially detract from or interfere with the
use of the properties subject thereto or affected thereby, or otherwise
materially impair business operations involving such properties.


 


2.5                               Governmental Consents. 
No consent, approval, order or authorization of, or registration,
qualification, designation, declaration or filing with, any court, tribunal,
administrative or other agency or commission or other governmental authority or
instrumentality anywhere in the world (“Governmental
Entity”) is required in connection with the consummation of the transactions
contemplated by the Financing Agreements, except for such filings required
pursuant to applicable federal and state securities laws and blue sky laws or
for such other filings which are not required by applicable law to be effected
prior to the Closing,


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


4
















 


which filings will be
effected within the required statutory period. 
The Company has obtained each federal, state, county, local or foreign
governmental consent, license, permit, grant, or other authorization of a Governmental
Entity (i) pursuant to which the Company currently operates or holds any
interest in any of its properties or (ii) that is required for the
operation of the Company’s business as conducted or the holding of any such
interest ((i) and (ii) herein collectively called the “Authorizations”), and all of such
Authorizations are in full force and effect, except where failure to obtain or
have any such Authorizations could not reasonably be expected to have a
Material Adverse Effect on the Company. 
For purposes of this Agreement, “Material
Adverse Effect” means with respect to any entity or group of
entities any event, change or effect that is materially adverse to the
condition (financial or otherwise), properties, assets, liabilities, business,
operations or results of, operations or prospects of such entity and its
subsidiaries, taken as a whole.


 


2.6                               Offering. 
Subject in part to the truth and accuracy of each Investor’s
representations set forth in Section 3 of this Agreement, the offer, sale
and issuance of the Series E Preferred Stock as contemplated by this
Agreement are exempt from the registration requirements of the Securities Act
of 1933, as amended (the “Securities Act”),
and the qualification or registration requirements of applicable blue sky
laws.  Neither the Company nor any authorized
agent acting on its behalf will take any action hereafter that would cause the
loss of such exemptions.


 


2.7                               Litigation. 
There is no action, suit, proceeding, claim, arbitration or
investigation pending before any agency, court or tribunal, foreign or
domestic, or, to the Company’s knowledge, currently threatened in writing
against the Company or threatened against or affecting any of the officers,
directors or employees of the Company that questions the validity of the
Financing Agreements or the right of the Company to enter into any of such
agreements, or to consummate the transactions contemplated hereby or thereby,
or that could reasonably be expected to result, either individually or in the
aggregate, in a loss to the Company in excess of $100,000 or that could
otherwise materially affect the business (as presently conducted or as
currently proposed to be conducted), assets or condition of the Company,
financially or otherwise, or any change in the current equity ownership of the
Company, nor is the Company aware that there is any substantial basis for any
of the foregoing.  The foregoing includes
actions, suits, proceedings or investigations pending or, to the Company’s
knowledge, threatened in writing (or to the Company’s knowledge, any substantial
basis therefor) involving the prior employment of any of the Company’s
employees, their use in connection with the Company’s business of any
information or techniques allegedly proprietary to any of their former
employers, or their obligations under any agreements with prior employers.  The Company is not a party or subject to the
provisions of any order, writ, injunction, judgment or decree of any court or
government agency or instrumentality. 
There is no action, suit, proceeding or investigation by the Company
currently pending or which the Company intends to initiate regarding its
business.


 


2.8                               Financial Statements. 
The Company has made available to each Investor its  standalone unaudited financial statements
(balance sheet, income statement, and statement of cash flows) as of November 30,
2005 (the “Financial Statements”).  Such Financial Statements (i) are in
accordance with the books and records of the Company, (ii) are in all
material respects 


 






[ * ] = 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 406 of the
Securities Act of 1933, as amended.


 


5

















 


true, correct and
complete and present fairly and accurately the financial condition of the
Company at the date or dates therein indicated and the results of operations
for the period or periods therein specified and (iii) have been prepared
in accordance with U.S. generally accepted accounting principles (“GAAP”) applied on a consistent basis throughout the periods
indicated and with each other (except that the unaudited financial statements
do not:  (i) have notes thereto, or (ii) contain
certain classifications as required by GAAP). Except as set forth in the
Financial Statements, the Company does not have any material liabilities of any
nature (whether mature or unmatured accrued, absolute, unliquidated, contingent
or otherwise, whether due or to become due, regardless of when asserted, and
whether or not required to be reflected in financial statements in accordance
with GAAP) other than liabilities and obligations directly accrued by and
attributable to the Company that have arisen after November 30, 2005 in
the ordinary course of business consistent with past practice (none of which is
a liability resulting from breach of contract, breach of warranty, tort,
infringement, claim or lawsuit).  The
Company maintains and will continue to maintain through the Closing and
post-closing a standard system of accounting established and administered in
accordance with GAAP.


 


2.9                               Permits. 
The Company has all franchises, permits, governmental licenses and any
similar authority necessary for the conduct of the Company’s business as
presently conducted, the lack of which could reasonably be expected to
adversely affect the Company’s business as presently conducted, properties or
financial condition of the Company.  The
Company is not in default in any material respect under any of such franchises,
permits, governmental licenses or other similar authority.


 


2.10                        Title to Properties and Assets;
Liens, Etc.  The Company has good and marketable title to
all of its tangible properties, interests in tangible properties and assets,
real and personal, reflected in the Balance Sheet or acquired after the Balance
Sheet Date (except such properties, interests in properties and assets sold or
otherwise disposed of since the Balance Sheet Date in the ordinary course of
business), or with respect to leased properties and tangible assets, to the
knowledge of the Company, valid leasehold interests in, free and clear of all
mortgages, liens, pledges, charges or Encumbrances of any kind or
character.  The plants, tangible property
and equipment of the Company that are used in the operations of the Company’s
business as presently conducted are in good operating condition and repair,
subject to normal wear and tear.


 


3.                                      REPRESENTATIONS AND WARRANTIES OF
THE INVESTORS.  Each Investor hereby severally and not
jointly represents, warrants and (as applicable) covenants to the Company as
follows:


 


3.1                               Authorization. 
Such Investor has full power and authority to enter into each of the
Financing Agreements, to the extent it is a party, and each such agreement constitutes
its valid and legally binding obligation, enforceable against such Investor in
accordance with its terms, except (i) as limited by applicable bankruptcy,
insolvency, reorganization, moratorium and other laws of general application
affecting enforcement of creditors’ rights generally, (ii) as limited by
laws relating to the availability of specific performance, injunctive relief or
other 


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


6

















 


equitable remedies and (iii) to
the extent the indemnification provisions contained in the Investors’ Rights
Agreement may be limited by applicable federal or state securities laws.


 


3.2                               Purchase Entirely for Own Account. 
This Agreement is made with such Investor in reliance upon Investor’s
execution of this Agreement and such Investor hereby  confirms
that the Shares and the Conversion Shares to be received by such Investor will
be acquired for investment for such Investor’s own account, not as a nominee or
agent, and not with a view to the sale or distribution of any part thereof, and
that such Investor has no present intention of selling, granting any
participation in, or otherwise distributing the same.  By executing this Agreement, such Investor
further represents that such Investor has no contract, undertaking, agreement
or arrangement with any person to sell, transfer, or grant participation to
such person or to any third person, with respect to any of the Shares or
Conversion Shares.


 


3.3                               Disclosure of Information. 
Such Investor believes it has been provided for review all the
information it considers necessary or appropriate for deciding whether to
purchase the Series E Preferred Stock. 
Such Investor further represents that it has had an opportunity to ask
questions and receive answers from the Company regarding the terms and
conditions of the offering of the Series E Preferred Stock and the Company’s
business, properties, prospects and financial condition of the Company. The
foregoing, however, does not limit or modify the representations and warranties
in Section 2 of this Agreement or in any of the other Financing Agreements
or the right of the Investors to rely thereon.


 


3.4                               Further Limitations on
Disposition.  Without in any way limiting the
representations set forth in this Agreement, each Investor further agrees not to
make any disposition of all or any portion of the Shares (or the Conversion
Shares) unless and until the transferee has agreed in writing for the benefit
of the Company to be bound by this Section 3.4 and:


 


(a)                                  There is then in effect a registration
statement under the Securities Act covering such proposed disposition and such
disposition is made in accordance with such registration statement; or


 


(b)                                  (i) Such Investor shall have
notified the Company of the proposed disposition and shall have furnished the
Company with a reasonable statement of the circumstances surrounding the
proposed disposition, and (ii) if requested by the Company, such Investor
shall have furnished the Company with an opinion of counsel, reasonably
satisfactory to the Company that such disposition will not require registration
under the Securities Act. It is agreed that the Company will not require
opinions of counsel for transactions made pursuant to Rule 144 except in
unusual circumstances.


 


(c)                                  Notwithstanding the provisions of subsections
(a) and (b) above, no such registration statement or opinion of
counsel shall be necessary for a transfer (i) by a Investor to any of its
affiliated entities or (ii) by a Investor that is a partnership to a
partner of such partnership or a retired partner of such partnership who
retires after the date hereof, or to the estate of any such partner or retired
partner or the transfer by gift, will or intestate succession of 


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


7

















 


any partner to his or her spouse or to the siblings,
lineal descendants or ancestors of such partner or his or her spouse, in each
case, if the transferee agrees in writing to be subject to the terms hereof to
the same extent as if it was an original Investor hereunder.


 


3.5                               Legends. 
It is understood that the certificates evidencing the Shares (or the
Conversion Shares) may bear one or all of the following or comparable legends:


 


(a)                                  “THESE SECURITIES HAVE NOT BEEN
REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.  THEY MAY NOT BE SOLD, OFFERED FOR SALE,
PLEDGED OR HYPOTHECATED IN THE ABSENCE OF A REGISTRATION STATEMENT IN EFFECT
WITH RESPECT TO THE SECURITIES UNDER SUCH ACT OR AN OPINION OF COUNSEL
SATISFACTORY TO THE COMPANY THAT SUCH REGISTRATION IS NOT REQUIRED OR UNLESS
SOLD PURSUANT TO RULE 144 OF SUCH ACT.”


 


(b)                                  Any legend required by the Bylaws of the
Company or the securities laws of any state or other governmental or regulatory
agency having authority over the issuance of the Shares (or the Conversion
Shares).


 


3.6                               Reliance by Company. 
Such Investor understands that the representations, warranties,
covenants and acknowledgements set forth in Section 3 constitute a
material inducement to the Company entering into this Agreement.


 


3.7                               No Reliance on Others. 
Each Investor agrees that no Investor nor any Investor’s controlling
persons, officers, directors, partners, agents, or employees shall be liable to
any other Investor for any action heretofore or hereafter taken or omitted to
be taken by any of them in connection with the issuance and sale of the Series E
Preferred Stock (including the Common Stock issuable upon conversion thereof)
contemplated hereunder.


 


3.8                               Accredited Investor.  Investor represents that it is an accredited
investor within the meaning of Regulation D under the Securities Act.


 


4.                                      CONDITIONS OF INVESTORS’
OBLIGATIONS AT CLOSING.


 


Investors’ obligations to
purchase the Shares at the Closing are subject to the satisfaction, at or prior
to the Closing Date, of the following conditions:


 


4.1                               Representations and Warranties
True; Performance of Obligations.  The
representations and warranties made by the Company in Section 2 hereof
shall be true and correct in all material respects, except for representations
and warranties that are qualified as to materiality or Material Adverse Effect
which shall be true and correct in all respects, as of the Closing Date with
the same force and effect as if they had been made as of the Closing Date, and
the Company shall have performed all obligations and conditions herein required
to be performed or observed by it on or prior to the Closing.


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


8

















 


4.2                               Consents, Permits, and Waivers. 
The Company shall have obtained any and all consents, permits and
waivers necessary or appropriate for consummation of the transactions
contemplated by the Financing Agreements except for such as may be properly
obtained subsequent to the Closing.


 


4.3                               Filing of Restated Charter. 
The Restated Charter shall have been filed with the Secretary of State
of the State of Delaware and shall continue to be in full force and effect as
of the Closing Date.


 


4.4                               Corporate Documents. 
The Company shall have delivered to Investors or their counsel, copies
of all corporate documents of the Company as Investors shall reasonably
request.


 


4.5                               Reservation of Conversion Shares. 
The Conversion Shares issuable upon conversion of the Shares shall have
been duly authorized and reserved for issuance upon such conversion.


 


4.6                               Compliance Certificate. 
The Company shall have delivered to Investors a Compliance Certificate,
executed by the Chief Executive Officer of the Company, dated as of the Closing
Date, to the effect that the conditions specified in subsections 4.1, 4.2, 4.3
and 4.5 of this Section 4 have been satisfied.


 


4.7                               Secretary’s Certificate. 
Investors shall have received from the Company’s Secretary, a
certificate having attached thereto (i) the Company’s Restated Charter as
in effect at the time of the Closing, (ii) the Company’s Bylaws as in
effect at the time of the Closing, (iii) resolutions approved by the Board
authorizing the transactions contemplated hereby, (iv) resolutions
approved by the Company’s stockholders authorizing the filing of the Restated
Charter, and (v) good standing certificates (including tax good standing)
with respect to the Company from the applicable authorities in Delaware and any
other jurisdiction in which the Company is qualified to do business, dated as
of a recent date prior to the Closing.


 


4.8                               Investors’ Rights Agreement. 
The Investors’ Rights Agreement substantially in the form attached
hereto as Exhibit C shall
have been executed and delivered by the parties thereto.


 


4.9                               Co-Sale Agreement. 
The Co-Sale Agreement substantially in the form attached hereto as Exhibit D shall have been executed and
delivered by the parties thereto.


 


4.10                        Voting Agreement. 
The Voting Agreement substantially in the form attached hereto as Exhibit E shall have been executed and
delivered by the parties thereto.


 


5.                                      CONDITIONS OF THE
COMPANY’S OBLIGATIONS AT CLOSING.


 


The Company’s obligation
to issue and sell the Shares at each Closing is subject to the satisfaction, on
or prior to such Closing, of the following conditions:


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


9

















 


5.1                               Representations and
Warranties True.  The representations and warranties in Section 3
made by those Investors acquiring Shares hereof shall be true and correct at
the date of the Closing, with the same force and effect as if they had been
made on and as of said date.


 


5.2                               Performance of
Obligations.  Such Investors shall have performed and
complied with all agreements and conditions herein required to be performed or
complied with by such Investors on or before the Closing.


 


5.3                               Filing of Restated
Charter.  The Restated Charter shall have been filed
with the Secretary of State of the State of Delaware.


 


5.4                               Investors’ Rights
Agreement.  The Investors’ Rights Agreement substantially
in the form attached hereto as Exhibit C
shall have been executed and delivered by Investors.


 


5.5                               Co-Sale Agreement. 
The Co-Sale Agreement substantially in the form attached hereto as Exhibit D shall have been executed and
delivered by the parties thereto.


 


5.6                               Voting Agreement. 
The Voting Agreement substantially in the form attached hereto as Exhibit E shall have been executed and
delivered by the parties thereto.


 


5.7                               Consents, Permits, and
Waivers.  The Company shall have obtained any and all
consents, permits and waivers necessary or appropriate for consummation of the
transactions contemplated by the Financing Agreements except for such as may be
properly obtained subsequent to the Closing.


 


6.                                      SURVIVAL.


 


6.1                               Survival of Representations and
Warranties.  The representations, warranties, covenants
and agreements made herein shall survive the closing of the transactions
contemplated hereby.  All statements as
to factual matters contained in any certificate or other instrument delivered
by or on behalf of the Company pursuant hereto in connection with the
transactions contemplated hereby shall be deemed to be representations and
warranties by the Company hereunder solely as of the date of such certificate
or instrument.


 


7.                                      AMENDMENT; WAIVER.


 


7.1                               Amendment, Waiver. 
Any term of this Agreement may be amended and the observance of any term
of this Agreement may be waived (either generally or in a particular instance
and either retroactively or prospectively), only with the written consent of
the Company, the holders of a majority of the Common Stock that is issued or
issuable upon conversion of the Series E Preferred Stock sold pursuant to
this Agreement.  Any amendment or waiver
effected in accordance with this paragraph shall be binding upon each holder of
any securities purchased under this Agreement at the time outstanding
(including securities into which such securities are convertible), each future holder
of all such securities and the Company, provided, however, the failure by any
party at any time to require performance or compliance by the others of any of
its obligations or agreements will in no way affect the right to require such
performance or 


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


10

















 


compliance at any
time thereafter.  The waiver by any party
of a breach of any provision of this Agreement will not be treated as a waiver
of any preceding or succeeding breach of such provision or as a waiver of the
provision itself.


 


8.                                      MISCELLANEOUS.


 


8.1                               Notices. 
All notices and other communications hereunder shall be in writing and
shall be deemed given: (i) upon personal delivery to the party to be
notified; (ii) when sent by confirmed telex or facsimile if sent during
normal business hours of the recipient, if not, then on the next business day; (iii) domestically,
five (5) business days after having been sent by registered or certified
mail, return receipt requested, postage prepaid; or (iv) one (1) business
day after deposit with a nationally or internationally, as applicable,
recognized overnight courier, specifying next day delivery, if domestic, or if
international, then three (3) business days thereafter, with written
verification of receipt.  All communications
shall be sent as follows (provided, that any party hereto (and such party’s
permitted assigns) may by notice so given change its address for future notices
hereunder by giving ten days’ advance notice to all other parties):


 


(a) if to the Investors:


 


at the address set forth on Exhibit A


 


(b) if to the Company:


 


Affymax, Inc.


4001 Miranda Avenue


Palo Alto, CA 94304


Attention: CEO


Telephone No.: (650) 812-8700


Facsimile No.: (650) 434-0832


 


with a copy to:


 


Cooley Godward LLP


Five Palo Alto Square


3000 El Camino Real


Palo Alto, CA 94306-2155


Attention: Barbara A. Kosacz


Telephone No.: (650) 843-5000


Facsimile No.: (650) 849-7400


 


8.2                               Interpretation. 
When a reference is made in this Agreement to an Exhibit or a
Schedule, such reference shall be to an Exhibit or Schedule to this
Agreement unless otherwise indicated. 
The words “include,” “includes” and “including” when used herein shall
be deemed in each case to be followed by the words “without limitation.”  The words “all” and “any” when 


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


11

















 


used herein shall be
deemed in each case to mean “any and all.” 
The phrase “provided to,” “furnished to,” and terms of similar import in
this Agreement means that a paper copy of the information referred to has been
furnished to the party to whom such information is to be provided. The phrases “the
date of this Agreement,” “the date hereof,” and terms of similar import, unless
the context otherwise requires, shall be deemed to refer to February       ,
2006.  For purposes of this Agreement,
whenever the context requires: the singular number shall include the plural,
and vice versa; the feminine gender shall include the masculine and neuter
genders; the masculine gender shall include the feminine and neuter genders;
and the neuter gender shall include the masculine and feminine genders.  The term “person” shall include natural
persons, corporations, partnerships, limited liability companies and other
entities unless the context of such reference clearly indicates that only
natural persons are intended and any reasonable interpretation of such context
would exclude entities. The table of contents and headings contained in this
Agreement are for reference purposes only and shall not affect in any way the
meaning or interpretation of this Agreement.


 


8.3                               Counterparts; Facsimile Delivery. 
This Agreement may be executed in one or more counterparts and delivered
by facsimile, all of which shall be considered one and the same agreement and
shall become effective when one or more counterparts have been signed by each
of the parties and delivered to the other parties, it being understood that all
parties need not sign the same counterpart. 
A facsimile signature shall be deemed an original.


 


8.4                               Attorney’s Fees. 
If any action at law or in equity is necessary to enforce or interpret
the terms of this Agreement, the prevailing party shall be entitled to
reasonable attorney’s fees, costs and necessary disbursements in addition to
any other relief to which such party may be entitled.


 


8.5                               Entire Agreement;
Nonassignability; Parties in Interest.  This
Agreement (which includes the Exhibits and the Schedules) and the documents and
instruments and other agreements specifically referred to herein or therein or
delivered by the Company pursuant hereto or otherwise, (a) constitute the
entire agreement among the parties with respect to the subject matter hereof
and supersede all prior agreements and understandings, both written and oral
and (b) shall not be assigned by operation of law or otherwise except as
otherwise specifically provided herein, except that the Investors may assign
their respective rights and delegate their respective obligations hereunder to
their respective affiliates and partners. 
Except as otherwise provided herein, the terms and conditions of this
Agreement shall inure to the benefit of and be binding upon the respective
successors and assigns of the parties (including transferees of any Shares).


 


8.6                               Severability. 
In the event that any provision of this Agreement, or the application
thereof, becomes or is declared by a court of competent jurisdiction to be
illegal, void or unenforceable, the remainder of this Agreement will continue
in full force and effect and the application of such provision to other persons
or circumstances will be interpreted so as reasonably to effect the intent of
the parties hereto.  The parties further
agree to replace such void or unenforceable provision of this Agreement with a
valid and enforceable provision that will 


 






[ * ] = 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 406 of the
Securities Act of 1933, as amended.


 


12

















 


achieve, to the extent
possible, the economic, business and other purposes of such void or
unenforceable provision.


 


8.7                               Remedies Cumulative. 
All remedies in any of the Financing Agreements expressly conferred upon
a party will be deemed cumulative with and not exclusive of any other remedy
conferred hereby, or by law or equity upon such party, and the exercise by a
party of any one remedy will not preclude the exercise of any other remedy.


 


8.8                               Governing Law. 
This Agreement shall be governed by and construed in accordance with the
laws of the State of Delaware to the extent applicable without reference to
such state’s principles of conflicts of law; provided, however, that issues
involving the corporate governance of any of the parties hereto shall be
governed by their respective jurisdictions of incorporation.


 


8.9                               Rules of Construction. 
The parties hereto agree that they have been represented by counsel
during the negotiation, preparation and execution of this Agreement and,
therefore, waive the application of any law, regulation, holding or rule of
construction providing that ambiguities in an agreement or other document will
be construed against the party drafting such agreement or document.


 


8.10                        Finder’s Fee. 
Except as set forth on the Schedule of Exceptions, each party represents
that it neither is nor will be obligated for any finders’ fee or commission in
connection with this transaction.  Each
Investor agrees to indemnify and to hold harmless the Company from any
liability for any commission or compensation in the nature of a finders’ fee
(and the costs and expenses of defending against such liability or asserted
liability) for which such Investor or any of its officers, partners, employees
or representatives is responsible. The Company agrees to indemnify and hold
harmless each Investor from any liability for any commission or compensation in
the nature of a finders’ fee (and the costs and expenses of defending against
such liability or asserted liability) for which the Company or any of their
respective officers, employees or representatives is responsible.


 


8.11                        Expenses. 
Each party shall pay all costs and expenses that it incurs with respect
to the negotiation, execution, delivery and performance of the Agreement.


 


8.12                        Aggregation of Stock. 
All shares of the Series E Preferred Stock or Common Stock issued
upon conversion of the Series E Preferred Stock held or acquired by
affiliated entities or persons shall be aggregated together for the purpose of
determining the availability of any rights under this Agreement.


 


8.13                        Delays or Omissions. 
It is agreed that no delay or omission to exercise any right, power or
remedy accruing to any party, upon any breach, default or noncompliance by
another party under the Financing Agreements, shall impair any such right,
power or remedy, nor shall it be construed to be a waiver of any such breach,
default or noncompliance, or any acquiescence therein, or of or in any similar
breach, default or noncompliance thereafter occurring.  It is further agreed that any waiver, permit,
consent or approval of any kind or character on any 


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


13

















 


party’s part of any
breach, default or noncompliance under the Financing Agreements or any waiver
on such party’s part of any provisions or conditions of the Financing
Agreements must be in writing and shall be effective only to the extent
specifically set forth in such writing.


 


{The remainder of this page has
been intentionally left blank.}


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


14
















 


IN WITNESS WHEREOF, the parties hereto have executed the SERIES E PREFERRED STOCK PURCHASE AGREEMENT as of the date
set forth in the first paragraph hereof.


 


COMPANY:


 


AFFYMAX,
INC.


 


 


	
  By:

  	
   

  	
   

  
	
  Name:  Arlene Morris

  
	
  Title:  President and CEO

  
	
   

  
	
  Address:

  	
  4001 Miranda Avenue

  
	
   

  	
  Palo Alto, CA 94304

  
				



 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 

















 


	
   

  	
  INVESTORS:

  
	
   

  	
   

  
	
   

  	
  TAKEDA
  PHARMACEUTICAL COMPANY LIMITED

  
	
   

  	
   

  
	
   

  	
  By:

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  Print Name:

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
  Title:

  	
   

  



 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 

















 


EXHIBIT
K


 


INITIAL
PRESS RELEASE


 




	
  

  	
  

  






 


AFFYMAX AND
TAKEDA ANNOUNCE AGREEMENT


TO DEVELOP AND COMMERCIALIZE HEMATIDETM IN JAPAN


 


Affymax to Receive More than $100 Million in
Upfront and


Milestone Payments Plus Sales Royalties


 


Takeda to Obtain an Exclusive License for
Development and


Commercialization in Japan


 


PALO ALTO, Calif. (February 12), and OSAKA, Japan (February 13), 2006 —Affymax, Inc. (Affymax) and Takeda
Pharmaceutical Company Limited (Takeda) today announced that the companies have entered into an exclusive
agreement to develop and commercialize Affymax’s lead product candidate,
HematideTM, in Japan for the treatment of anemia.


 


Hematide, a synthetic
peptide-based next-generation erythropoiesis-stimulating agent
(ESA), is designed to stimulate the production of red blood cells.  It
is currently being evaluated in four Phase 2 clinical trials in
the United States and Europe to treat anemia in chronic kidney disease (CKD) and cancer patients.


 


Pursuant to  the
agreement, Takeda will pay to Affymax US$17 million as an up-front payment and will
also purchase US$10 million of  Affymax’s
stock. In addition, Affymax is eligible to receive clinical and regulatory
milestone payments totaling US$75 million. 
After
the
launch of Hematide in Japan, Affymax would receive a double digit royalty on
Hematide sales in the territory.  Takeda
is responsible for all development and commercialization costs in Japan, and
Affymax is responsible


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


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for the manufacture and supply of
drug substance to Takeda.  Takeda then
will manufacture the final commercial product for use in Japan.


 


“With this agreement, Affymax has delivered on a key corporate
goal.  This major milestone achievement
will allow us to focus our own now considerable resources on developing
Hematide in the United States and Europe, while Takeda focuses on the
significant market in Japan” said Arlene M. Morris, Affymax’s president and
chief executive officer.  “Takeda is an
optimal partner because they have the development experience in this area and
commitment necessary to accelerate and successfully develop and commercialize
Hematide in Japan.”


 


“Hematide is a novel ESA that is an
important product based on the evidence we have observed,” said Yasuchika Hasegawa, Takeda’s president and chief operating officer.  “We are excited to aggressively move this
promising new drug candidate forward to address a very large underserved
patient population.  I also believe this product will enhance our
urological and cancer-related franchises, which we position as part of our core
therapeutic areas.”


 


ESAs, which have been used
successfully to manage anemia in patients with CKD and cancer-related anemia,
represent a $12 billion market worldwide, of which Japan is about $1 billion
and growing.  ESA therapy has
dramatically reduced the need for blood transfusions and the frequency and
severity of anemia-associated morbidity, resulting in an improved quality of
life for patients.


 


About HematideTM


 


Hematide
has a completely novel amino acid sequence that is unrelated to erythropoietin,
a hormone that stimulates red blood cell formation, or to any other known
naturally-occurring human sequences. 
Compared to therapeutic proteins, Hematide has the potential advantages
of an uncomplicated chemical synthesis, a simple dosing schedule characterized
by once monthly administration, and room temperature storage.  In addition, antibodies generated to erythropoietin
do not cross-react with Hematide, providing a rationale to study it in patients
with pure red cell aplasia (PRCA), a rare autoimmune disease caused by
development of 


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


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antibodies
to recombinant erythropoietin.  A Phase 2
study to evaluate Hematide in PRCA patients is scheduled to begin in early
2006.


 


About
Affymax


 


Affymax, Inc. is a
clinical-stage pharmaceutical company that is developing a rich pipeline of
synthetic peptide-based drugs against clinically validated targets for the
treatment of kidney diseases and cancer. 
Hematide, the Company’s
lead clinical product candidate, is a novel peptide-based drug designed to
stimulate red blood cell production currently in Phase 2 trials for the
potential treatment of anemia associated with chronic kidney disease and
cancer.  For more information go to
www.affymax.com.


 


About Takeda


 


Takeda,
located in Osaka, Japan, is a research-based global company with its main focus
on pharmaceuticals. As the largest pharmaceutical company in Japan and one of
the global leaders of the industry, Takeda is committed to striving toward
better health for individuals and progress in medicine by developing superior
pharmaceutical products. Additional information about Takeda is available
through its corporate website, www.takeda.com/index-e.html


 


# # #


 


	
  For
  Further Information:

  	
   

  
	
  Affymax

  	
   

  
	
  Mary
  Fermi

  	
  Daryl
  Messinger

  
	
  Senior Director, Commercial Development

  	
  WeissComm Partners (for Affymax) 

  
	
  650-812-8722

  	
  415-999-2361

  
	
  mary_fermi@affymax.com

  	
  daryl@weisscommpartners.com

  



 


Takeda


Seizo Masuda


Coordinator, Corporate
Communications


+81-6-6204-2060


Masuda_Seizo@takeda.co.jp


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


3

















 


SCHEDULE 10.2


 


1.              [ * ]


 


2.             On June 9, 2004, Affymax filed
a civil complaint in the Regional Court Munich I in the Federal Republic of
Germany against Ortho Pharmaceutical Corporation and Ortho-McNeil
Pharmaceutical, Inc. of Raritan, New Jersey (collectively “Ortho”). 
Affymax’s complaint alleges that Affymax is an owner of European Patent
Application EP 0 892 812 which currently lists Ortho as the sole applicant, and
that Affymax should be named as the applicant, or in the alternative
co-applicant, of that European application. [ * ] The  case remains pending in Regional Court Munich
I.


 


3.     
On September 27, 2004, Affymax filed a civil complaint in the United
States District Court for the Northern District of Illinois against Johnson &
Johnson, Ortho-McNeil Pharmaceutical, Inc., Ortho Pharmaceutical
Corporation, and The R.W. Johnson Pharmaceutical Research Institute d/b/a
Johnson & Johnson Pharmaceutical Research and Development
(collectively “J&J-Ortho”). Affymax’s complaint alleges that J&J-Ortho
have applied for and in some cases been granted patents covering subject matter
that was invented by Affymax’s scientists in connection with a Research and
Development Agreement between Affymax and J&J-Ortho (“R&D Agreement”).
Affymax alleges that, based on the applicable patent laws and the R&D
Agreement, Affymax’s scientists should have been identified as inventors on the
patents and patent applications, and Affymax should have been granted ownership
rights to these patents and patent applications. The complaint also alleges
that J&J-Ortho has breached the R&D Agreement and Affymax has suffered
certain damages as a result of said breach. Pursuant to the terms of the
R&D Agreement, Affymax entered into a period of good faith discussions with
J&J-Ortho to resolve, if possible, the dispute between the parties
regarding the subject matter of Affymax’s civil complaints in the US and
Europe. On October 13, 2004, Affymax and J&J-Ortho entered into a
standstill agreement in order to facilitate good faith discussions between the
parties to resolve the dispute. On March 8, 2005, Affymax and
J&J-Ortho entered into an expanded standstill agreement and Affymax filed a
motion to voluntarily dismiss without prejudice the civil complaint in the U.S.
District Court in Illinois; the motion was granted and the U.S. complaint was
dismissed without prejudice and with leave to refile the complaint with the
court prior to September 8, 2005.  Affymax filed a Motion to
Reinstate the U.S. complaint in the U.S. District Court in Illinois on September 8,
2005, and the motion was granted by the court reinstating the case.  On October 10,
2005, Affymax filed an Amended Complaint in the US District Court in Illinois
amending the names of the Defendants to reflect the current business units of
Ortho and deleting certain claims regarding USSN 60/207,654, USSN 09/863,600
and PCT/US01/16654.  On November 1,
2005, Ortho filed an Answer, Affirmative Defenses, and Counterclaims to the
Affymax complaint.  In their filing,
Ortho denies all material claims against them raised in the Affymax complaint
and pleads counterclaims which include, inter alia, that Ortho should be the
sole owner of US Patent 5,986,047 and the joint owner of US Patents 5,773,569
and 5,830,851, all of which are currently assigned to Affymax.  In the November 1, 


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


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2005 filing, Ortho also
states that the case pending in the US District Court for the Northern District
of Illinois should be dismissed and the case decided by binding arbitration as
specified in the 1992 agreement between the parties.  On November 11, 2005, Ortho filed a
motion with the Illinois court  to
dismiss or stay the US and German litigations and compel the parties to binding
arbitration. On December 2, 2005, Affymax filed an Answer to Defendants’
Counterclaims which denies all material allegations in defendants’
counterclaims. On December 14, 2005, [ * ]


 


[ * ]


 






[ * ] = 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 406 of
the Securities Act of 1933, as amended.


 


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