COLLABORATION AND LICENSE AGREEMENT

Collaboration Agreement

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AFFYMAX, INC | TAKEDA PHARMACEUTICAL COMPANY LIMITED

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Title: COLLABORATION AND LICENSE AGREEMENT
Governing Law: Delaware Date: 8/5/2009
Industry: Biotechnology and Drugs Law Firm: Cooley Godward Sector: Healthcare

COLLABORATION AND LICENSE AGREEMENT, Parties: affymax inc , takeda pharmaceutical company limited

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 Hematide™ 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:

TABLE OF CONTENTS

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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

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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

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	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

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	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

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	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

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	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

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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

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15.11	Counterparts	87

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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.

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.

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

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

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

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

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

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

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;

(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.

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

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.

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.

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.

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.

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

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.

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.

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

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.

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,

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

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

[ * ] 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.

(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

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

[ * ] 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,

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

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

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

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.

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;

(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

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

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

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

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 30 th and October 31 st 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,

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.

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

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}™” 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

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

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 [ * ] .

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