Exhibit 10.2

EXECUTION VERSION

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

 

DETAILING AGREEMENT

between

sanofi-aventis US LLC

and

Relypsa, Inc.

Dated as of August 10, 2015

 

 

 

 

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EXECUTION VERSION

 

Table of Contents

 

1.

 

DEFINITIONS

 

1

 

 

  

 

 

2.

 

GOVERNANCE AND SALES PROGRAM PLANS

 

8

 

 

 

 

 

 

 

 

 

2.1

 

Joint Commercialization Committee

 

8

 

 

2.2

 

Working Groups

 

9

 

 

2.3

 

Alliance Managers

 

9

 

 

2.4

 

Sales Program Plan

 

9

 

 

2.5

 

Additional Activities

 

10

 

 

 

 

 

3.

 

PROMOTIONAL MATERIAL DELIVERABLES AND OBLIGATIONS

 

10

 

 

 

 

 

 

 

 

 

3.1

 

Grant of Right; [***]; [***]

 

10

 

 

3.2

 

Co-Promotion Obligations

 

10

 

 

3.3

 

Responsibilities of the Parties

 

12

 

 

3.4

 

License Grant; Ownership of Product

 

15

 

 

3.5

 

No Distribution by Sanofi

 

16

 

 

 

 

 

 

 

4.

 

[***]

 

16

 

 

 

 

 

 

 

 

 

4.1

 

[***]

 

16

 

 

 

 

 

 

 

5.

 

REGULATORY COMPLIANCE

 

16

 

 

 

 

 

 

 

 

 

5.1

 

Marketing Authorization and Regulatory Matters

 

16

 

 

5.2

 

Recalls

 

16

 

 

5.3

 

Returns

 

16

 

 

5.4

 

Adverse Drug Experiences and Product Complaints

 

16

 

 

5.5

 

Product Inquiries

 

16

 

 

5.6

 

Communications with FDA

 

17

 

 

5.7

 

[***]

 

17

 

 

 

 

 

 

 

6.

 

COMPENSATION

 

17

 

 

 

 

 

 

 

 

 

6.1

 

Compensation Arrangement

 

17

 

 

6.2

 

Payment Terms

 

19

 

 

 

 

 

 

 

7.

 

RECORD KEEPING; REPORTING AND AUDITS

 

20

 

 

 

 

 

 

 

 

 

7.1

 

Record Keeping

 

20

 

 

7.2

 

Financial Audit Rights

 

20

 

 

7.3

 

Monthly Reports

 

20

 

 

 

 

 

 

 

8.

 

CONFIDENTIALITY

 

20

 

 

 

 

 

 

 

 

 

8.1

 

Non-use and Nondisclosure Obligations

 

20

 

 

8.2

 

Confidential Information

 

21

 

 

8.3

 

Disclosure Required by Law

 

21

i

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

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EXECUTION VERSION

 

 

 

8.4

 

Remedies

 

21

 

 

8.5

 

Return of Confidential Information

 

21

 

 

8.6

 

Disclosure of Agreement, Publicity and Publications

 

22

 

 

 

 

 

 

 

9.

 

REPRESENTATIONS, WARRANTIES AND COVENANTS

 

22

 

 

 

 

 

 

 

 

 

9.1

 

Mutual Representations and Warranties and Covenants

 

22

 

 

9.2

 

Relypsa Representations and Warranties and Covenants

 

23

 

 

9.3

 

DISCLAIMER

 

23

 

 

 

 

 

 

 

10.

 

INDEMNIFICATION, LIABILITY LIMITS AND INSURANCE

 

24

 

 

 

 

 

 

 

 

 

10.1

 

Indemnification by Sanofi

 

24

 

 

10.2

 

Indemnification by Relypsa

 

24

 

 

10.3

 

Procedure

 

24

 

 

10.4

 

Limitations of Liability

 

25

 

 

10.5

 

Insurance

 

25

 

 

 

 

 

 

 

11.

 

TERM AND TERMINATION

 

25

 

 

 

 

 

 

 

 

 

11.1

 

Term

 

25

 

 

11.2

 

Termination Rights

 

25

 

 

11.3

 

Effect of Termination

 

26

 

 

11.4

 

No Waiver of Remedies

 

27

 

 

11.5

 

Survival of Certain Provisions

 

27

 

 

 

 

 

 

 

12.

 

MISCELLANEOUS

 

27

 

 

 

 

 

 

 

 

 

12.1

 

Integration

 

27

 

 

12.2

 

Relationship Between the Parties

 

27

 

 

12.3

 

Modification & Non-Waiver

 

27

 

 

12.4

 

Assignment

 

27

 

 

12.5

 

No Third Party Beneficiaries

 

28

 

 

12.6

 

Severability

 

28

 

 

12.7

 

Notices

 

28

 

 

12.8

 

Compliance with Laws

 

29

 

 

12.9

 

Force Majeure

 

29

 

 

12.10

 

Dispute Resolution

 

29

 

 

12.11

 

Jurisdiction and Governing Law

 

30

 

 

12.12

 

Interpretation

 

30

 

 

12.13

 

Counterparts

 

30

 

 

12.14

 

Further Assurances

 

30

 

 

 

ii

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EXECUTION VERSION

 

Exhibits

 

Exhibit A

 

Initial Sales Program Plan for the Product

 

 

 

Exhibit B

 

Sales Force Incentive Plan

 

 

 

Exhibit C

 

Technical Agreement

 

 

 

Exhibit D

 

Form of Service Fee Invoice

 

 

 

Exhibit E

 

Form of [***]

 

 

 

Exhibit F

 

Form of [***]

 

 

 

Exhibit G

 

Monthly and Calendar Quarterly Detail Report

 

 

 

Exhibit H

 

Press Release

 

 

 

Exhibit I

 

Sanofi Expenses Per Detail

 

 

 

i

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

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EXECUTION VERSION

 

DETAILING AGREEMENT

This detailing agreement (the “Agreement”) is effective as of August 10, 2015
(the “Effective Date”) by and between Relypsa, Inc., a Delaware corporation
located at 100 Cardinal Way, Redwood City, CA 94063, USA (“Relypsa”) and
sanofi-aventis US LLC, a Delaware limited liability company located at 55
Corporate Drive, Bridgewater NJ 08807 (“Sanofi”).  Relypsa and Sanofi are
referred to individually as a “Party” and collectively as the “Parties”.

RECITALS

A. Relypsa has developed and filed for regulatory approval by the U.S. Food and
Drug Administration a therapeutic product known as Patiromer for use in treating
hyperkalemia;

B. Relypsa intends, after receiving regulatory approval for such product, to
promote such product to physicians and allied health care professionals in the
United States;

C. Sanofi promotes and details products to such professionals with practices
that include patients potentially suitable for treatment with such product; and

D. Relypsa desires to engage Sanofi to detail such product in the United States
upon the terms and subject to the conditions contained herein.

In consideration of the foregoing and the covenants and promises contained in
this Agreement, and intending to be legally bound, the Parties agree as follows:

1. Definitions

The capitalized terms used in this Agreement (other than the headings of the
Sections or Articles) have the following meanings set forth in this Article 0,
or, if not listed in this Article 0, the meanings as designated in the text of
this Agreement.

1.1. “Additional Activities” has the meaning set forth in Section 0.

1.2. “[***]” has the meaning set forth in Section 0.

1.3. “Agreement” has the meaning set forth in the preamble hereto.

1.4. “Affiliate” of a Party means, as of the Effective Date or at any time
during the Term, any individual, sole proprietorship, firm, partnership,
corporation, trust, joint venture or other entity, whether de jure or de facto,
which, directly or indirectly, controls, is controlled by or is under common
control with such Party.  As used in this definition, “control” means direct or
indirect ownership of at least fifty percent (50%) of the outstanding equity
voting stock (or such lesser percentage which is the maximum allowed to be owned
by a foreign corporation in a particular jurisdiction) of a Party or other
entity.

1.5. “Alliance Manager” means, with respect to a Party, an employee of such
Party designated by such Party to oversee contact between the Parties for all
matters between meetings of the JCC and shall have such other responsibilities
as the Parties may agree in writing after the Effective Date.

1

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

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EXECUTION VERSION

 

1.6. “Anti-Kickback Statute” means the Medicare and Medicaid Anti-Kickback
Statute set forth at 42 U.S.C. § 1320a-7b(ii), as amended or superseded, and the
regulations promulgated thereunder from time to time.

1.7. “Applicable Law” means all applicable provisions of any and all federal,
national, state, provincial, and local statutes, laws, rules, regulations,
administrative codes, ordinances, decrees, orders, decisions, injunctions,
awards, judgments, permits and licenses of or from any governmental authorities,
including, without limitation, the Prescription Drug Marketing Act of 1987 and
regulations thereunder, the FD&C Act and regulations thereunder, and HIPAA and
regulations thereunder, the Anti-Kickback Statute, the FD&C Act, and HIPAA.

1.8. “Business Day” means any day other than a Saturday, Sunday or other day
that is a recognized national holiday in the United States or that is a day that
commercial banks are authorized to close under the Applicable Laws of, or are in
fact closed in, San Francisco, CA or New York, NY.

1.9. “Calendar Quarter” means each of the three (3) month periods ending March
31, June 30, September 30 and December 31; provided, however, (a) the first
Calendar Quarter of the Term shall extend from the Effective Date to the end of
the Calendar Quarter in which the Effective Date occurs; and (b) the last
Calendar Quarter shall extend from the beginning of the Calendar Quarter in
which this Agreement expires or terminates until the effective date of such
expiration or termination.

1.10. “Calendar Year” means, for the first Calendar Year, the period beginning
on the Effective Date and ending on December 31, 2015, and for each Calendar
Year thereafter, each successive period beginning on January 1 and ending twelve
(12) consecutive calendar months later on December 31, except that the last
Calendar Year shall commence on January 1 of the year in which this Agreement
expires or terminates and end on the effective date of such expiration or
termination.

1.11. “[***]” has the meaning set forth in Section 0.

1.12. “CME” has the meaning set forth in Section 0.

1.13. “Commercially Reasonable Efforts” means efforts a Party would apply to
[***] using a level of effort consistent with the exercise of good faith and
prudent scientific and business judgment, which shall [***], taking into account
the [***] [***].  

1.14. “Commitment Term” has the meaning set forth in Section 0.

1.15. “[***]” means [***].

1.16. “Confidential Information” has the meaning set forth in Section 0.

1.17. “[***] Commencement Date” means the date on which [***].

1.18. “Detail” means a face-to-face presentation by a  sales representative to a
Professional in a setting appropriate for meaningful dialogue, during which such
sales representative makes a presentation with respect to the Product or the
applicable disease state therefor, or [***], in each case, to such Professional.

2

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

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EXECUTION VERSION

 

1.19. “[***] Commencement Date” has the meaning set forth in Section 0.

1.20. “Dispute” has the meaning set forth in Section 0.

1.21. “Dispute Notice” has the meaning set forth in Section 0.

1.22. “Dollar” or “$” means the legal tender of the United States.

1.23. “Effective Date” has the meaning set forth in the preamble hereto.

1.24. “Expected Details” has the meaning set forth in Section 3.2(b)(iii).

1.25. “FDA” means the United States Food and Drug Administration and any
successor agency thereto.

1.26. “FD&C Act” means the Food, Drug and Cosmetic Act as amended or superseded,
and the regulations promulgated thereunder from time to time.

1.27. “First Commercial Sale” means, with respect to a Product and a country,
the first sale for monetary value for use or consumption by the end user of such
Product in such country after regulatory approval for such Product has been
obtained in the Territory.  Sales prior to receipt of regulatory approval for
such Product, such as so-called “treatment IND sales,” “named patient sales,”
and “compassionate use sales,” shall not be construed as a First Commercial
Sale.

1.28. “Force Majeure Event” has the meaning set forth in Section 0.

1.29. “GAAP” means U.S. generally accepted accounting principles, consistently
applied.

1.30. “Genzyme” means Genzyme, a company incorporated under the laws of
Massachusetts with its principal office located at 500 Kendall Street,
Cambridge, Massachusetts 02142.

1.31. “HIPAA” means the Healthcare Insurance Portability & Accountability Act of
1996 as amended or superseded, and the regulations promulgated thereunder from
time to time.

1.32. “Indemnitee” has the meaning set forth in Section 0.

1.33. “Indemnitor” has the meaning set forth in Section 0.

1.34. “Initial Commitment Term” has the meaning set forth in Section 0.

1.35. “Joint Commercialization Committee” or “JCC” has the meaning set forth in
Section 0.

1.36. “Losses” has the meaning set forth in Section 0.

1.37. “Market” means, when used as a verb, to market, sell, distribute, Promote
or advertise a product.

1.38. “[***]” has the meaning set forth in Section 0.

3

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

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EXECUTION VERSION

 

1.39. “Net Sales”  means, with respect to a given period of time, the gross
amount recorded from arms-length transactions by Relypsa, its Affiliates, and
(sub)licensees for sales of Product to Third Parties in the Territory in such
period, less the following deductions from such gross amounts which are actually
incurred, allowed, paid, accrued or specifically allocated:  

(a) credits or allowances actually granted for damaged Product, returns or
rejections of Product, price adjustments and billing errors;

(b) governmental and other rebates (or equivalents thereof) granted to managed
health care organizations, health management organizations, pharmacy benefit
managers (or equivalents thereof), federal, state/provincial, local and other
governments, their agencies and purchasers and reimbursers or to trade
customers;

(c) normal and customary trade, cash and quantity discounts, recalls, allowances
and credits actually allowed or paid;

(d) [***];

(e) transportation costs, including insurance, for outbound freight related to
delivery of the Product to the extent included in the gross amount invoiced;

(f) sales taxes, value added taxes (VAT), and other taxes directly linked to the
sales of Product to the extent included in the gross amount invoiced;

(g) the actual amount of any write offs for bad debt directly relating to sales
of Product in such period; and

(h) [***].

Sales between or among Relypsa and its Affiliates or (sub)licensees shall be
excluded from the computation of Net Sales, but the subsequent final sales in
the Territory to Third Parties by Relypsa or its Affiliates or (sub)licensees
shall be included in the computation of Net Sales.  For clarity, sales outside
the Territory between or among Relypsa and its Affiliates, (sub)licensees shall
be excluded from the computation of Net Sales.

1.40. “OIG” has the meaning set forth in Section 0.

1.41. “Orange Book” means the FDA’s publication, Approved Drug Products with
Therapeutic Equivalence Evaluations, commonly known as the Orange Book.

1.42. “Party” or “Parties” has the meaning set forth in the preamble hereto.

4

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

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EXECUTION VERSION

 

1.43. “Patent” means any: (a) U.S. patent application, including a provisional
application, non-provisional application, continuation application, a continued
prosecution application, a continuation-in-part application, a divisional
application, a reissue application, or a re-examination application; and (b) (i)
U.S. patent, including utility and design patents; (ii) reissues, substitutions,
confirmations, registrations, validations, or re-examinations thereof; and (iii)
extensions, renewals or restorations of any of the foregoing by existing or
future extension, renewal or restoration mechanisms, including supplementary
protection certificates or the equivalent thereof.

1.44. “PDMA” means the Prescription Drug Marketing Act of 1987 as amended or
superseded, and the regulations promulgated thereunder from time to time.

1.45. “PDUFA Date” means October 21, 2015.

1.46. “Person” means an individual, a corporation, a partnership, an
association, a trust or other entity or organization, including a government or
political subdivision or an agency or instrumentality thereof.

1.47. “Personnel” means Sanofi Personnel and Relypsa Personnel.

1.48. “PhRMA Code” means the PhRMA Code on Interactions with Health Care
Professionals, as amended from time to time.

1.49. “Post-Approval Initial Training” has the meaning set forth in Section 0.

1.50. “Pre-Approval Initial Training” has the meaning set forth in Section 0.

1.51. “Primary Detail” means a Detail in which [***].  For purposes of
clarification, prior to the [***] Commencement Date, a Primary Detail shall mean
a Detail in which [***].  

1.52. “Product” means a product that contains the active ingredient patiromer
sorbitex calcium [***].

1.53. “Product Baseline” means, subject to Section 0, the following [***] Net
Sales of Product for [***]: (a) for [***] Net Sales of Product equal to [***];
(b) for [***] Net Sales of Product equal to [***]; and (c) for [***], the amount
of [***] Net Sales of Product as [***].

1.54. “[***]” has the meaning set forth in Section 0.

1.55. “Product Incentive Payment” has the meaning set forth in Section 0.

1.56. “Product Trademark” means the trademark VELTASSA™.

1.57. “Product Promotional and Educational Materials” has the meaning set forth
in Section 0(i).

1.58. “[***]” has the meaning set forth in Section 0.

5

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

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EXECUTION VERSION

 

1.59. “Product Target Audience” means, as to the Product, the Professionals
called upon by Sanofi’s nephrology sales force when detailing [***]; provided
that Sanofi may [***].

1.60. “Professional” means physicians and [***] to whom Sanofi [***] (including,
without limitation, [***]).  

1.61. “Promotion” means the activities normally undertaken by a pharmaceutical
company’s sales force to implement marketing plans and directed to encouraging
the purchase and appropriate use of a particular prescription pharmaceutical
product.  When used as a verb, “Promote” means to engage in such activities.

1.62. “PSR” means individually, a Sanofi PSR or a Relypsa PSR, and “PSRs” means
Sanofi PSRs and Relypsa PSRs.

1.63. “Regional Business Director” means an individual employed by a Party who
is responsible for supervising such Party’s PSRs.

1.64. “Relypsa” has the meaning set forth in the preamble hereto.

1.65. “Relypsa Indemnitees” has the meaning set forth in Section 0.

1.66. “Relypsa Personnel” has the meaning set forth in Section 0.

1.67. “[***]” has the meaning set forth in Section 0.

1.68. “Relypsa PSR” means a member of Relypsa’s sales force.

1.69. “[***]” has the meaning set forth in Section 0.

1.70. “[***]” has the meaning set forth in Section 0.

1.71. “Sales Management Team” means one (1) or more [***] or [***] of Relypsa or
Sanofi, as the case may be, each of whom shall be primarily responsible for
[***] of the [***] within a geographic region of the Territory.

1.72. “Sales Program Plan” means the plan describing the activities to be
performed by each Party in the Territory during the Commitment Term, as more
fully set forth in Section 0, and as amended from time to time.  The initial
Sales Program Plan is attached hereto as Exhibit A.

1.73. “Sales Territory” means a geographic region within the Territory in which
Relypsa PSRs shall be assigned by Relypsa and Sanofi PSRs shall be assigned by
Sanofi, as the case may be, to Detail the Product.  Under [***] may the [***]
modify [***].

1.74. “[***]” means [***].

1.75. “Sanofi” has the meaning set forth in the preamble hereto.

1.76. “Sanofi Indemnitees” has the meaning set forth in Section 0.

6

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

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EXECUTION VERSION

 

1.77. “Sanofi Minimum Details Commitment” means [***]; provided, however, if
[***] (such event, the “[***]”, and such [***]), then (a) Sanofi shall notify
Relypsa thereof within [***] ([***]) days of such [***]; (b) the Sanofi Minimum
Details Commitment [***] shall be [***], and (c) any [***] after such
notification with respect to the Sanofi Minimum Detail Commitment shall [***];
provided however, pursuant to this Section, under no circumstance shall the
Sanofi Minimum Detail Commitment [***].  For example, (x) there are the
following [***]:  [***]; and (y) the Sanofi Minimum Detail Commitment ([***]) is
[***], then, absent any [***], the Sanofi Minimum Detail Commitment shall be as
follows: [***].

1.78. “Sanofi Personnel” has the meaning set forth in Section 0.

1.79. “Sanofi PSR” means a member of Sanofi’s nephrology sales force. For
clarity, a Sanofi PSR may be either an employee of Sanofi or [***] under this
Agreement.

1.80. “[***]” has the meaning set forth in Section 0.

1.81. “[***]” has the meaning set forth in Section 1.80.

1.82. “Secondary Detail” means a Detail in which [***].  For purposes of
clarification, prior to the [***] Commencement Date, a Secondary Detail shall
mean a Detail in which [***].   

1.83. “Senior Executive Officer” means [***] for Relypsa (or such officer’s
designee) and [***] for Sanofi (or such officer’s designee).

1.84. “Service Fee” has the meaning set forth in Section 0.

1.85. “Subject Persons” has the meaning set forth in Section 0.

1.86. “Technical Agreements” has the meaning set forth in Section 0.

1.87. “Term” has the meaning set forth in Section 0.

1.88. “Territory” means the United States of America, and its territories and
possessions.

1.89. “Third Party” means any Person other than a Party or any Party’s
Affiliates.

1.90. “Third Party Claims” has the meaning set forth in Section 0.

1.91. “Training Program” means any training of PSRs with respect to the Product
as set forth in Section 3.3(c).

1.92. “Working Group” has the meaning set forth in Section 0.

7

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

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EXECUTION VERSION

 

2. Governance and Sales Program Plans

2.1 Joint Commercialization Committee.

(a) Structure and Procedures.  Within [***] ([***]) days after the Effective
Date, the Parties shall establish a joint commercialization committee (the
“Joint Commercialization Committee” or the “JCC”), which shall be comprised of
[***] from each Party, each with appropriate experience in the promotion of
therapeutic products. In addition, the JCC may from time to time include
additional non-voting, ad-hoc representatives from either Party on specific
issues as the need arises; provided, however, that such representatives shall
not vote or otherwise participate in the decision-making process of the JCC and
are bound by obligations of confidentiality and non-disclosure equivalent to
those set forth in Article 0.  The chairperson of the JCC shall be a Relypsa JCC
member. The chairperson of the JCC shall distribute a draft agenda reasonably
prior to, and meeting minutes reasonably promptly following, each meeting of the
JCC.  The JCC shall meet periodically as agreed by the Parties, but in no event
less than [***] and on an ad hoc basis thereafter, in each case, in person not
more than [***] (with [***]), or by video teleconference or teleconference as
mutually agreed by the Parties.  Each Party shall bear all expenses it incurs
for participating in any JCC meetings, including all travel and living
expenses.  At least [***] from each Party must be present at any meeting of the
JCC to represent a quorum for voting purposes.  The members of the JCC shall
seek to make all determinations to be made by them unanimously following full
discussion thereof (with [***] having [***] on each matter).

(b) Dispute Resolution.  If the JCC is unable to reach a unanimous decision on
any matter for which it has responsibility as set forth in this Agreement within
[***] ([***]) days after such matter is first presented to the JCC, then such
matter shall be immediately escalated to the Parties’ Senior Executive Officers
for resolution within [***] ([***]) days after such matter is presented to such
Senior Executive Officers.  If such Senior Executive Officers do not resolve
such matter within [***] ([***]) days after it is presented to them, then [***]
shall make the final decision on any such matters or disputes relating to
[***].  Notwithstanding the foregoing, [***] may not use such final decision
making authority to (i) [***], (ii) [***]; or (iii) [***].  Each Party shall
retain the rights, powers, and discretion granted to it under this Agreement and
no such rights, powers, or discretion shall be delegated to or vested in the JCC
unless such delegation or vesting of rights is expressly provided for in this
Agreement or the Parties expressly so agree in writing.  The JCC shall not have
the power to amend, modify or waive compliance with this Agreement, which may
only be amended, modified or compliance with which may only be waived, in each
case, as provided in Section 0.

(c) Duties.  Subject to the terms of this Agreement, the JCC shall have the
overall responsibility to manage and coordinate all Promotion activities
relating to the Product in the Territory during the Term, and shall in
particular:

(i) supplement or update, as applicable, the Sales Program Plan pursuant to
Section 0;

(ii) coordinate the activities of the Parties to implement and execute any Sales
Program Plan approved pursuant to Section 0, which activities shall include,
with respect to the Product, coordinating all [***] [***], coordinating the
[***] and the [***] pursuant to Section [***];

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(iii) create a Working Group to develop and establish compliance and training
processes contemplated in [***] applicable to the Sales Program Plan, [***], and
[***] coordination in sufficient time to permit [***] and [***] no later than
[***];

(iv) discuss whether a [***] should be [***] pursuant to Section [***]; serve as
a forum for the Parties to provide updates on Product performance and marketing
plans of action, including in connection with CME or grant programs pursuant to
Section 3.3(b)(iii);

(v) establish and oversee all Working Groups (if any) pursuant to Section 0;

(vi) resolve disputes that may arise in the Working Groups; and

(vii) perform such other functions as may be assigned to the JCC hereunder.

2.2 Working Groups.  From time to time during the Commitment Term, the JCC may
establish and delegate duties to other committees, sub-committees, or directed
teams (each, a “Working Group”) on an “as needed” basis to oversee particular
projects or activities.  Each such Working Group shall be constituted and shall
operate as the JCC determines; provided that each Working Group shall have [***]
from each Party except as otherwise mutually agreed by the Parties.  Working
Groups may be established on an ad hoc basis as the JCC shall determine.  Each
Working Group and its activities shall be subject to the oversight, review and
approval of, and shall report to the JCC.  The authority of any Working Group
shall never exceed that specified for the JCC under this Article 0.

2.3 Alliance Managers.  Each Party shall appoint and notify the other Party of
its respective Alliance Manager, including any changes in such designation from
time to time during the Term.  Further, the Parties acknowledge and agree that
each Party may designate their respective Alliance Manager to be a member of the
JCC.

2.4 Sales Program Plan.

(a) Sales Program Plan.  The principal mechanism by which the Parties shall
coordinate their respective Promotion activities for Product under this
Agreement shall be through the Sales Program Plan.  The initial Sales Program
Plan is attached as Exhibit A.  Within [***] ([***]) days after the Effective
Date, the Parties shall, by mutual written consent, [***] the Sales Program Plan
as the Parties deem necessary, including any necessary budgets.  The [***] Sales
Program Plan shall cover the [***]. With respect to periods after the [***], the
JCC shall review and update the Sales Program Plan [***], subject to Section
0.  Each such update shall be agreed upon by the JCC not later than [***]
([***]) days prior to the end of the Calendar Year preceding that to which the
update applies.  

(b) General Plan Contents as to the Product. The Sales Program Plan shall, at a
minimum, include: (i) [***] to market the Product in the Territory and
thereafter during the Term; (ii) [***] to market the Product in the Territory
related to [***]; (iii) Promotion activities to be conducted [***]; (iv) [***],
(v) if [***] decides to [***], subject to Section 0, a plan pursuant to which
such PSRs will [***] or forms for [***]; and (vi) budgets for [***] each Party
under this Agreement relating to the Promotion of Product in the Territory
[***].

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2.5 Additional Activities.  During the Term, the Parties may discuss
opportunities to work together on the following Product-related activities in
the Territory: [***] (the “Additional Activities”).  The Parties agree that the
Additional Activities shall not be part of this Agreement or any Sales Program
Plan. Any such Additional Activities will be subject to a separate written
agreement or amendment executed by the Parties that includes [***], and other
relevant terms and conditions.

3. Promotional Material Deliverables and Obligations

3.1 Grant of Right; [***]; [***].

(a) Grant of Right.

(i) Relypsa hereby engages Sanofi, on a [***] basis [***], and Sanofi agrees, to
Detail the Product to the Product Target Audience in the Territory, during the
Commitment Term, in accordance with the terms of this Agreement.  For clarity,
[***].

(ii) If [***] (the “[***]”), then [***] [***], [***] shall [***].  [***] shall
[***].  If [***] in accordance with this Section 0, [***]. If [***], then [***].
For clarity, [***] pursuant to this Section 3.1(a)(ii).  Notwithstanding the
foregoing, if [***], or [***] (other than [***]) (any such [***], “[***]”), then
(A) within [***] ([***]) days after the end of each [***] thereafter in which
[***], Relypsa shall send Sanofi a report detailing the number of [***]
delivered; and (B) if [***] ([***]), then [***] (including [***]) and [***],
[***].  For clarity, neither the conduct of [***] nor the [***] as contemplated
under this Section 3.1(a)(ii) shall [***].  

(b) [***].  Subject to Section 0, [***], [***]; provided however that
[***].  [***] agrees that [***]. [***] agrees that [***]. In addition [***]
agree that, [***] [***].

(c) [***].  Subject to Section 3.1(b), [***] agrees that, unless it has [***]
(which [***], provided that [***]), [***], in the Territory during the Term of
this Agreement [***] (e.g., [***]), [***].  Notwithstanding the foregoing,
[***].  Such [***], however, will [***].  [***] agrees that [***], and that
[***].  [***] agrees that [***], and that [***]. In addition, [***] that,
[***].  

3.2 Co-Promotion Obligations.

(a) Each Party shall Detail and, in the case of Relypsa, otherwise Promote and
Market, the Product within the Territory in accordance with the terms of this
Agreement and the Sales Program Plan. Commencing on the date on which [***]
(such date, the “[***] Commencement Date”), until the [***] Commencement Date,
Sanofi shall Detail the Product within the Territory, which Details shall be
focused exclusively on [***]; provided that in the event of [***] for the
Product, [***] may [***] if  [***] performance thereof  would [***]. On and
after the [***] Commencement Date until the expiration or termination of the
Commitment Term, Sanofi shall Detail the Product within the Territory, as set
forth in the Sales Program Plan and pursuant to the Training Program.  All
Details for the Product to be performed by Sanofi hereunder shall be [***]
Details, unless otherwise agreed by the Parties [***].  [***], Sanofi shall be
free, if it so chooses in its sole discretion, to Promote additional products
other than the Product (regardless of whether such additional products are
products owned or controlled by Sanofi, its Affiliates or a Third Party).

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(b) Professional Sales Representatives (PSRs).

(i) Generally.  As of the Effective Date and thereafter during the Commitment
Term, Sanofi shall engage Sanofi PSRs that are members of the nephrology sales
force that [***] to Professionals within the Product Target Audience to fulfill
its Detailing obligations hereunder.

(ii) Responsibility for Sanofi PSRs.   Sanofi has sole authority and
responsibility for managing, hiring, firing, disciplining and compensating the
Sanofi PSRs including paying for all benefits, wages, special incentives,
employment taxes, and workers’ compensation, and shall pay any and all other
costs associated with the Sanofi PSRs, except as expressly provided herein.

(iii) Expected Details. From the [***] Commencement Date through the end of the
[***], Sanofi shall use Commercially Reasonable Efforts to deliver the number of
[***] Details per [***] set forth in the Sales Program Plan (the “Expected
Details”).

(c) Sales Management.

(i) Each Party shall be responsible for supervising its PSRs.  Each Party shall
require its PSRs and members of its Sales Management Team not to identify,
either expressly or through implication, themselves as an employee or agent of
the other Party.  Each Party shall be responsible for any failure of its PSRs or
members of its Sales Management Team to comply with such requirement.

(d) Commitment Term.  The “Initial Commitment Term” shall commence as of the
[***] Commencement Date and shall terminate automatically on December 31,
2017.  The Initial Commitment Term may be extended in twelve (12) month
increments by the mutual written agreement of the Parties achieved at least
[***] ([***]) months prior to the end of the existing Initial Commitment Term
(together with the Initial Commitment Term, the “Commitment Term”).

(e) Managed Care.  During the Term, the managed care strategy for Product in the
Territory including contracting with, and pricing for, managed care customers,
shall be the exclusive responsibility and authority of [***].

(f) Sales Force Incentive Plan.  As soon as practicable, but in any event prior
to the [***] Commencement Date, each Party shall establish and, throughout the
Commitment Term, maintain, a sales force incentive plan. Each such plan shall
conform with the principles set forth on Exhibit B which shall be binding upon
the Parties.

(g) Employment Qualifications.  Sanofi PSRs responsible for Detailing the
Product in the Territory shall have the [***].

(h) Status of Sanofi and its Personnel.

(i) Relypsa is engaging Sanofi hereunder, and Sanofi shall perform its
obligations hereunder, strictly as an independent contractor.  Any Sanofi PSR,
Regional Business Director, member of the Sales Management Team and any other
employee, contractor or agent that is involved in performing Sanofi’s
obligations under this Agreement (collectively, “Sanofi Personnel”) shall not
be, and shall not be considered or deemed to be, employees of Relypsa for any
purpose.  Any Relypsa PSR, Regional Business Director, member

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of the Sales Management Team and any other employee, contractor or agent that is
involved in performing Relypsa’s obligations under this Agreement (collectively,
“Relypsa Personnel”) shall not be, and shall not be considered or deemed to be,
employees of Sanofi for any purpose.  Neither Party shall not have any
responsibility for the hiring, termination, compensation, benefits or other
conditions of employment or engagement of the Personnel of the other Party.

(ii) Sanofi Personnel are not eligible to participate in any benefits programs
offered by Relypsa to its employees, or in any pension plans, profit sharing
plans, insurance plans or any other employee benefits plans offered from time to
time by Relypsa to its employees.  Sanofi acknowledges and agrees that Relypsa
does not, and shall not, maintain or procure any workers’ compensation or
unemployment compensation insurance for or on behalf of Sanofi
Personnel.  Sanofi acknowledges and agrees that it shall be solely responsible
for paying all salaries, wages, benefits and other compensation which the Sanofi
Personnel may be entitled to receive in connection with the performance of the
services hereunder.

(iii) Relypsa Personnel are not eligible to participate in any benefits programs
offered by Sanofi to its employees, or in any pension plans, profit sharing
plans, insurance plans or any other employee benefits plans offered from time to
time by Sanofi to its employees.  Relypsa acknowledges and agrees that Sanofi
does not, and shall not, maintain or procure any workers’ compensation or
unemployment compensation insurance for or on behalf of Relypsa
Personnel.  Relypsa acknowledges and agrees that it shall be solely responsible
for paying all salaries, wages, benefits and other compensation which the
Relypsa Personnel may be entitled to receive in connection with the performance
of the services hereunder.

3.3 Responsibilities of the Parties.

(a) Product Materials.

(i) [***] shall be responsible for [***] the [***], [***] and [***] for the
Product in the Territory. Subject to Section 0, all marketing, advertising,
promotional, sales, educational (including medical education and disease state
materials) and communication materials used by either Party in the Marketing of
the Product in the Territory pursuant to this Agreement, in any format,
including audio, visual, digital or computer formats (collectively, the “Product
Promotional and Educational Materials”), shall be [***] and shall be subject to
the review and approval by [***] that is responsible for reviewing and approving
Product Promotional and Educational Materials (the “[***]”) prior to being used
by [***] in the Territory.

(ii) [***] shall be required to provide Product Promotional and Educational
Materials and sales training materials that comply with Applicable Law and with
Relypsa’s policies and procedures.  [***] shall be afforded sufficient
time  after receiving such materials from [***] to review and comment on such
materials and shall submit any proposed changes to [***] for review and approval
by [***].  Notwithstanding anything else in this Agreement to the contrary,
[***].  If [***], [***] shall [***].

(iii) Relypsa, [***], shall be responsible for the production and distribution
of all Product Promotional and Educational Materials.  Neither Sanofi nor
Relypsa shall distribute or permit any use of any Product Promotional and
Educational Materials that are not approved by the [***] as provided in Section
0. Relypsa shall be responsible for distributing Product Promotional and
Educational Materials to its Relypsa PSRs, Regional Business Managers and Sales
Management Team, and for ensuring use only of Product Promotional and
Educational Materials approved as provided hereunder. [***] shall distribute
Product Promotional and Educational Materials to [***] PSRs, Regional Business
Managers and Sales Management

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Team ([***]); provided that [***] shall first require [***], which shall [***].
Product Promotional and Educational Materials shall be used by Sanofi only for
the purposes of this Agreement. [***] will [***].  Notwithstanding anything to
the contrary, (A) Sanofi shall [***] to the extent reasonably necessary for
[***] as described herein, (B) the Parties shall immediately cease using any
previously approved Product Promotional and Educational Materials upon the
written request of Relypsa, and (C) Relypsa shall [***].

(b) CME and Grants; Speaker Programs.

(i) [***] shall have the sole right but not obligation, in its sole discretion,
for conducting or arranging for any continuing medical education (“CME”) or
grant programs relating to the Product during the Term.  For the avoidance of
doubt, [***] relating to the Product during the Term.

(ii) Relypsa shall have sole responsibility, in its sole discretion, for the
creation, approval and implementation of all speaker programs and other,
non-direct promotional activities relating to the Product during the
Term.  Relypsa may propose (through the JCC) that a given speaker program for
the Product should be [***].  Sanofi, however, shall have the [***], with
[***].   If [***] decides to proceed with any [***] for the Product, then such
program shall be subject to [***] applicable policies and, for clarity, such
[***] shall [***] as one or more Detail(s) under this Agreement.

(c) Sales Training.

(i) The JCC shall coordinate initial training of the Sanofi PSRs, Regional
Business Directors and Sanofi’s sales trainers with respect to the Product for
both Detailing the Product before and after regulatory approval of the Product
in the Territory (such initial training prior to such regulatory approval, the
“Pre-Approval Initial Training”, and such initial training after such regulatory
approval, the “Post-Approval Initial Training”).  Relypsa shall provide all
Relypsa-designated training personnel and training materials to Sanofi, at
[***].  Notwithstanding anything else in this Agreement to the contrary,
[***].  Relypsa will also [***] of for the [***] (including [***]) based upon
the [***].  Relypsa, [***], shall provide Sanofi with any additional, follow-on,
or reminder training materials for the Product that Relypsa provides to the
Relypsa PSRs, in quantities sufficient to supply all Sanofi PSRs, Regional
Business Directors and Sanofi’s sales trainers. The Parties will use
Commercially Reasonable Efforts to complete the Post-Approval Initial Training
as promptly as possible after regulatory approval has been obtained for the
Product in the Territory and prior to the date of First Commercial Sale in the
Territory.

(ii) Relypsa shall be responsible for training Sanofi’s sales trainers on any
materials necessary to perform any Post-Approval Initial Training.

(iii) After the Post-Approval Initial Training, Sanofi shall periodically
conduct additional trainings with respect to the Product for Sanofi’s sales
trainers and newly hired Sanofi PSRs and the Sanofi Regional Business Directors
during the Commitment Term.  Relypsa shall also [***] for the [***] [***]
related to [***] (including [***]) based upon the [***].  Each Sanofi PSR must
pass Relypsa’s Product Promotion certifications, in each case ((A) and (B)), (A)
in order to Detail anytime between the [***] Commencement Date and the [***]
Commencement Date and (B) in order to Detail anytime on or after the [***]
Commencement Date; provided that any [***].  Such Product Promotion
certifications shall be administered to each Sanofi PSR during the Training
Program.  Sanofi shall [***] certify to Relypsa that all Sanofi PSRs engaged in
activities under this Agreement have obtained such Product Promotion
certification.  Relypsa shall have the right, [***], to engage a Third Party
[***] to audit such Product Promotion certifications

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of Sanofi PSRs to confirm compliance with this Section 3.3(c)(iii).  Any such
audit will be conducted no more frequently than [***] by an independent expert
[***] during regular business hours.  Any such independent expert shall report
to Relypsa [***].  Such independent expert shall be bound by obligations of
confidentiality to Sanofi substantially similar to the provisions of Article 0,
and shall not be permitted to disclose to Relypsa any personally identifiable
information or other Confidential Information of Sanofi.

(iv) Promotional Claims.  Sanofi and Relypsa each agree to [***] the claims of
[***] for the Product made by the Parties’ respective PSRs and Sales Management
Teams to those that are [***] for the Product in the Territory.  Neither Party
shall make any changes to the final Product Promotional and Educational
Materials approved by the [***] pursuant to Section 0 above.  

(d) Communications with PSRs, Regional Business Directors, and Sales Management
Team.  Each Party shall have full responsibility for the dissemination of
information regarding the Product to its Sales Management Team, Regional
Business Directors and PSRs based on the Training Program and the Product
Promotional and Educational Materials approved by Relypsa pursuant to Section 0
above.  All written communications from Sanofi to Sanofi’s Sales Management Team
and the Sanofi PSRs concerning the Promotion of the Product to the Product
Target Audience shall comply with Sanofi policies on communication with sales
professionals.  The Parties shall discuss how potential legitimate
communications between Relypsa and any Sanofi PSR or Regional Business Directors
of Sanofi or Genzyme addressing potential overlapping target Professionals or
other legitimate need to coordinate Detailing efforts will be
coordinated.  Notwithstanding anything else set forth herein, under [***] may
[***] with, or [***], any [***] without [***] and the [***] in advance by [***].

(e) Pricing.  Relypsa shall have exclusive responsibility and authority with
respect to the pricing of the Product.  If Relypsa desires to [***] pricing for
the Product, Relypsa shall notify Sanofi [***] and [***] of such [***] to this
Agreement.

(f) Development; Manufacturing; Distribution; and Sale of Product.

(i) Relypsa shall be solely responsible for all activities relating to the
support for, or conduct of, any pre-clinical or clinical studies for the Product
in the Territory, including post-approval studies, investigator initiated
studies, health economics and outcomes/research, and phase 4 clinical
studies.  Costs and expenses for the foregoing activities shall be [***].  

(ii) Relypsa shall be solely responsible for all activities relating to
manufacture, supply and distribution of the Product (including [***]) in the
Territory, including order processing, inventory warehousing, delivery to
customers, invoicing and collection of receivables.  [***].

(iii) During the Term, Relypsa shall use its Commercially Reasonable Efforts to
manufacture, supply, Market and distribute the Product (including [***]) and
[***].

(iv) Relypsa shall have the sole right and responsibility to book and account
for all sales and to establish and modify the terms and conditions with respect
to the sale of the Product, including any terms and conditions relating to or
affecting the price at which the Product shall be sold, any discount
attributable to payments on receivables, distribution of the Product, credit to
be granted or refused and the like.  Relypsa shall process, administer and pay
any and all rebates, chargebacks and discounts for the Product.  

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(g) Product-Related Notifications from Relypsa.  Relypsa shall promptly notify
Sanofi of any information with respect to Product attributes or Promotion of the
Product in the Territory that has not been previously provided to Sanofi and
that: (i) Relypsa reasonably believes may [***], (ii) will trigger an obligation
under Applicable Law for Sanofi to communicate with any Third Party about the
Product, or (iii) is reasonably necessary or useful in order for Sanofi [***].

3.4 License Grant; Ownership of Product.

(a) License Grant.  Subject to the terms and conditions of this Agreement,
Relypsa hereby grants to Sanofi during the Term a non-exclusive,
non-sublicensable (except as permitted under Section 0) and non-transferable
license under all intellectual property controlled by Relypsa that claims or
covers the Product, solely as and to the extent necessary for Sanofi to perform
its obligations under this Agreement in the Territory.

(b) [***] and Subcontracting.  Sanofi shall have [***] to [***] to any Third
Party any of its rights under this Agreement without the prior written consent
of Relypsa, [***], including its rights under Section 0. In no event shall [***]
be deemed to relieve Sanofi of its liabilities or obligations to Relypsa under
this Agreement.  Sanofi expressly acknowledges and agrees that it shall remain
fully and unconditionally obligated and responsible for the full and complete
performance of all of its obligations under the terms and conditions of this
Agreement whether or not such performance is carried out by Sanofi or any of its
Affiliates, permitted sublicensees or subcontractors.  

(c) Product Trademark.  The Product shall be Detailed by Sanofi in accordance
with the terms and conditions of this Agreement under the Product
Trademark.  All use of the Product Trademark by Sanofi shall at all times inure
to the benefit of Relypsa as owner of the Product Trademark.  Relypsa’s
corporate logo shall be used on all Product Promotional and Educational
Materials and all Product packaging.  Sanofi shall use the Product Trademark,
other trademarks, trade names, and copyrighted materials of Relypsa only as
authorized by Relypsa, and Sanofi shall take all reasonable precautions to
ensure the protection of Relypsa’s rights in such trademarks, trade names and
materials. During the performance of their responsibilities under this
Agreement, [***] shall use [***] established practices with regard to possible
Product [***] to notify Relypsa of any such possible Product [***] of which any
[***] become aware. Sanofi shall not at any time use the Product Trademark,
other trademarks, trade names and copyrights of Relypsa in a manner inconsistent
with their established policy for use of such intellectual property unless
otherwise authorized by Relypsa in advance in writing.

(d) Ownership of Product.  Relypsa retains, and shall during the Term retain,
all proprietary and property interests in and to the Product until the point of
sale.  Relypsa’s National Drug Code (NDC) number shall at all times remain on
the Product.  Sanofi shall not have nor represent that it has any control over,
or proprietary or property interests in, the Product.

(e) No Additional Licenses or Rights.  Except as expressly set forth in Section
0, nothing in this Agreement grants Sanofi any license, right, title or interest
in or to any Patents, trademarks, know-how, trade secrets or other intellectual
property rights owned or controlled by Relypsa (either impliedly, by estoppel or
otherwise). Nothing in this Agreement grants Relypsa any license, right, title
or interest in or to any Patents, trademarks, know-how, trade secrets or other
intellectual property rights owned or controlled by Sanofi (either impliedly, by
estoppel or otherwise), including the right to use the Sanofi name or any Sanofi
trademark.  This Agreement conveys no implied rights or licenses to either
Party.

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3.5 No Distribution by Sanofi.  The Parties recognize that Sanofi may from time
to time receive orders for the Product directly from Third Parties.  In such
event, Sanofi shall promptly advise the customer that Sanofi is not authorized
to accept orders for the Product and it shall use its Commercially Reasonable
Efforts to provide the customer with adequate information to complete the
customer’s order directly with Relypsa, its Affiliates or agents.

4. [***]

4.1 [***] of [***].  The Parties acknowledge that, as of the Effective Date,
Relypsa [***] to [***] using [***].  Relypsa shall determine, in its sole
discretion, the [***] for [***] as part of the Sales Program Plan.  If Relypsa
[***], then Relypsa shall [***], and the Parties shall [***] for Relypsa to
[***], and for [***] to [***], [***] for [***].  

5. Regulatory Compliance

5.1 Marketing Authorization and Regulatory Matters.  Relypsa shall have the sole
right and responsibility between the Parties to file and maintain the
authorization to Market the Product as a pharmaceutical product in the United
States.  Relypsa shall own or hold legal responsibility and maintain the new
drug application with respect to the Product and shall retain responsibility for
all regulatory filings for the Product as required under the FD&C Act and
Applicable Law.

5.2 Recalls.  Relypsa shall have sole responsibility for, and shall make all
decisions with respect to, any recall, market withdrawals or any other
corrective action related to the Product.  If practical under the circumstances,
prior to making any such recall decision, Relypsa shall notify Sanofi’s Alliance
Manager.  At Relypsa’s request, Sanofi shall provide reasonable assistance to
Relypsa in conducting such recall, market withdrawal or other corrective action,
provided that Relypsa shall [***] in providing such assistance.

5.3 Returns.  Relypsa shall not engage in any action to encourage the return of
Product to Sanofi.  Any Product returned to Sanofi in error may, in [***], be
either rejected or returned as directed by Relypsa to Relypsa’s nearest
facility, with [***] costs therefor to be [***].  

5.4 Adverse Drug Experiences and Product Complaints.  Relypsa shall be solely
responsible for processing all adverse event reports, field reports and Product
complaints as required under Applicable Law.  Both Parties shall collaborate in
developing procedures related to adverse event and Product complaint reporting,
with such agreed upon procedures to be evidenced by one or more separate
agreements attached not later than [***] ([***]) days after the Effective Date
as Exhibit C to this Agreement (collectively, the “Technical Agreements”).

5.5 Product Inquiries.  If Sanofi, or any Sanofi PSR, receives any inquiries
about the Product, Sanofi’s responsibilities shall be as follows:

(a) For questions that Sanofi PSRs are unable to answer concerning Product
identification, Product availability or general inquiries, Sanofi shall contact
the appropriate person and department designated in writing by Relypsa (or such
other Person, at the address and phone number as Relypsa may designate from time
to time by written notice to Sanofi).

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(b) For medical inquiries, including those related to information outside of
labeling or which Sanofi PSRs are unable to answer, such medical inquiries shall
go to Relypsa’s Medical Information Department.

5.6 Communications with FDA.  All communications with the FDA concerning the
Product shall be the sole responsibility of Relypsa and, unless required by
Applicable Law, shall be initiated solely by Relypsa. Sanofi shall provide to
Relypsa prompt notice if the FDA or other governmental authority in the
Territory contacts Sanofi regarding the Product. Commencing upon the date that
the label for the Product has been established by the FDA, Relypsa shall provide
to Sanofi [***] notice of [***] with the FDA or other governmental authority in
the Territory with respect to the Product which would [***] or is [***]. Sanofi
shall provide reasonable assistance, at [***], to Relypsa with respect to any
such communications or interactions with the FDA described in this Section 0 to
the extent deemed necessary by Relypsa.

5.7 [***].  If [***] becomes subject to a binding [***] (“[***]”) with the [***]
(the [***]), [***] agrees to notify [***] in writing within [***] ([***]) days
of the effective date of such [***].  If under such [***], the [***] takes the
position that [***] is a “[***]” or “[***]” (as such term is defined in such
[***])), [***] will provide written notice of such designation of [***] promptly
and, use good faith efforts to [***] to make [***] or regarded as [***].

6. Compensation.

6.1 Compensation Arrangement.

(a) Payments.  Subject to the provisions of this Section 0, Relypsa hereby
agrees to compensate Sanofi by paying the sum of the Service Fee in Section 0
below plus the Product Incentive Payment in Section 0, as provided in Section 0.

(i) Service Fee.  Beginning as of the Effective Date, Relypsa shall pay Sanofi
on a [***] basis a non-refundable service fee (the “Service Fee”) as
follows.  Within [***] ([***]) days after the end of each [***], Sanofi shall
send Relypsa an invoice for the Service Fee in the form attached hereto as
Exhibit D equal to: [***] the number of [***] Details performed by Sanofi [***]
multiplied by [***].  Relypsa shall pay any undisputed Service Fee within [***]
([***]) days after receipt of such invoice.  Furthermore, Relypsa shall not be
obligated to pay any portion of the Service Fee that is applicable to [***]
Details that [***] in the Sales Program Plan.  The Parties shall use
Commercially Reasonable Efforts to resolve any disputes concerning an invoice in
good faith and in a reasonable period.

[***]

[***].

(ii) Product Incentive Payment.  Subject to Section 0 and Section 0, Relypsa
shall pay to Sanofi an amount equal to [***] percent ([***]%) of the amount of
Net Sales of Product for [***] that are above the Product Baseline for each such
[***] within [***] ([***]) days after the end of such [***] (the “Product
Incentive Payment”).  The Parties may extend the Product Incentive Payment for
[***] by agreeing in writing to a Product Baseline for such [***] no later than
[***] before the start of such [***].  Relypsa shall send Sanofi a report of
[***] in the form attached hereto as Exhibit E within [***] ([***]) days of the
end of each [***].  The Parties agree that, without limitation to Section
6.1(b)(i), in the event that (A)

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[***] and (B) [***], [***] shall notify [***] and, promptly following such
notification, the Parties shall  negotiate in good faith for a period of [***]
([***]) days a [***]; provided, however, [***] (including with respect to
[***]).  In the event the Parties are unable to agree to [***] within such
period, for clarity, Section 12.10 shall apply.  In the event of a [***] in a
given [***], then if the [***] are less than the [***], the Product Incentive
Payment payable in such

[***] shall be equal to [***].

(iii) All out-of-pocket Product-related expenditures incurred by Sanofi in
furtherance of this Agreement with respect to Product, including expenses
incurred in connection with [***] (including [***]), [***] (other than in
connection with [***]), [***] (including [***]), and [***], shall be [***];
provided that such [***] Relypsa prior to [***] or are within budgets
established in the Sales Program Plan.  Sanofi shall send Relypsa [***] on a
[***] basis in the form attached hereto as Exhibit F, and [***] within [***]
([***]) days after receipt [***].

(iv) Unless otherwise provided in this Agreement, Sanofi and Relypsa shall each
be responsible for all other costs and expenses such Party incurs that are
associated with their respective obligations under this Agreement.

(b) Adjustments for [***] Certain Obligations.

(i) [***].  If Relypsa [***] the Product in the Territory [***], including [***]
(each situation, a “[***]”), then as to each [***], Relypsa shall notify Sanofi
thereof and Relypsa shall have [***] ([***]) days from the commencement date of
such [***] to cure such [***].  If after such [***] ([***]) day period, such
[***] has not been cured and solely to the extent resulting from such [***]
(e.g., not because Sanofi is in breach of this Agreement), Sanofi does not meet
the Sanofi Minimum Detail Commitment for the [***] in which any such [***]
occurred, Sanofi shall be deemed to have met the Sanofi Minimum Detail
Commitment for Product for the purposes of Section 0 for such [***].

(ii) Failure by Sanofi to meet Minimum Commitments. Without limitation of
Section 0, if Sanofi does not meet the Sanofi Minimum Details Commitment (for
clarity, subject to Section 0) for [***] [***] for reasons unrelated to a [***]
or a failure by [***] to [***] and such shortfall is not made up [***], then
Relypsa shall not be obligated to make any Product Incentive Payment for [***].

(c) Effect of Termination on Payments.

(i) In the event this Agreement is terminated by Sanofi pursuant to Section 0,
[***] shall [***].

(ii) In the event this Agreement is terminated by Relypsa pursuant to Section 0
or Section 0, or by Sanofi pursuant to Section 0, the [***].

(iii) In the event this Agreement is terminated by Relypsa pursuant to Section
0, if as of the end of the calendar year in which this Agreement is so
terminated, Sanofi is [***] pursuant to the terms of Section 0 and Section
6.1(b), [***] shall pay [***], and if Sanofi is [***] pursuant to the terms of
Section 0 and Section 6.1(b), the [***].

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(iv) In the event this Agreement is terminated by either Party pursuant to
Section 0, Section 0, Section 0, Section 0 and Section 0, then after the end of
the calendar year in which this Agreement is terminates, [***] shall pay
[***].  For example, if the Agreement was in effect for ten (10) days in a
Calendar Year, [***].

6.2 Payment Terms.

(a) Payment of Compensation Payments.  Subject to the other terms of this
Agreement, Relypsa shall make any payments owed to Sanofi hereunder in Dollars
in accordance with Section 0.

(b) Taxes.

(i) Relypsa may withhold taxes, duties, levels fees or charges if revenue
authorities in such country require the withholding of taxes, duties, levies,
fees or charges on any amounts paid or owed by Relypsa hereunder.  Relypsa shall
deduct any such taxes, duties, levies, fees or charges from such payment and
shall pay such taxes, duties, levies, fees or charges to the proper taxing
authority on behalf of the payee.  Relypsa agrees to assist and provide evidence
of payment of such tax promptly to Sanofi in claiming exemption from such
deductions or withholdings under any applicable double taxation or similar
agreement or treaty.

(ii) If either Party [***] the other Party [***], then such [***] to the [***],
and the [***].

(c) Wire Transfers.  All payments hereunder shall be made to Sanofi from a bank
located in the United States by bank wire transfer in immediately available
funds to Sanofi in accordance with the wire instructions set forth below, which
may be changed only by written notice to Relypsa from the Alliance Manager of
Sanofi under Section 0.

 

Bank:

 

[***]

Bank Address:

 

[***]

Routing Number:

 

[***]

SWIFT Code:

 

[***]

Account Number:

 

[***]

Account Type:

 

[***]

Account Currency:

 

USD

Account Holder Name:

 

[***]

Ref:

 

[***]

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7. Record Keeping; Reporting and Audits

7.1 Record Keeping.  During the term and for a period of [***] ([***]) years
thereafter, unless otherwise required by Applicable Law, each Party shall keep
complete and accurate records in accordance with its business retention
policies, consistent with its internal standards in the United States as of the
date hereof,  to permit the other Party to confirm the completeness and accuracy
of (a) the information presented by Sanofi to Relypsa in the statement of
Details performed (or as provided under Section 0, the information presented by
Relypsa to Sanofi in the statement of Details performed), (b) the information
presented by Sanofi to Relypsa in any statement of  expenses reimbursed by
Relypsa hereunder, (c) the calculation of Net Sales by Relypsa, and (d) the
information presented by Relypsa to Sanofi  in the statements relating to the
Product Incentive Payment payable to Sanofi.  

7.2 Financial Audit Rights.  Subject to the other terms of this Section 0, at
the request of either Party upon at least [***] prior written notice to the
other Party, not more than [***], and at the expense of the requesting Party
(except as otherwise provided herein), the other Party shall permit an
independent certified public accountant reasonably selected by the requesting
Party and reasonably acceptable to the other Party to inspect (during regular
business hours) the relevant records required to be maintained by the other
Party under Section 0.  At the auditing Party’s request, the accountant shall be
entitled to review the applicable records relating to the information described
in Section 0 for the sole purpose of determining the correctness of such
information. In every case the accountant must have previously entered into a
confidentiality agreement with both Parties containing provisions substantially
similar to the provisions of Article 0.  Such independent accountant shall
[***].  Results of any such review shall be made available to both Parties and
shall be binding on both Parties.  The cost of the audit shall be borne by the
auditing Party, unless the audit reveals (a) an underpayment by Relypsa of any
amounts due to Sanofi hereunder or (b) a deficiency in the number of Details
reported by Sanofi to Relypsa, in each case ((a) and (b)), of at least [***]
percent ([***]%) from the applicable amounts reported hereunder, in which case,
in the case of clause (a), Relypsa shall bear the cost of such audit and, in the
case of clause (b), Sanofi shall bear the cost of such audit.  If such audit
reveals a discrepancy in the amount paid by Relypsa to Sanofi hereunder
(including as a result of the number of Details reported by Sanofi to Relypsa
hereunder), Relypsa shall reimburse Sanofi for any underpayment and Sanofi shall
reimburse Relypsa for any overpayment, as applicable, within [***] ([***]) days
of the accountant’s determination.

7.3 Monthly Reports.  Within [***] after the end of each month, in each case
during each Commitment Term, Sanofi shall provide to Relypsa a report in the
form attached hereto as Exhibit G listing the number of Details performed in the
immediately preceding [***] by Sanofi PSRs, which report shall be non-binding on
both Parties.

8. Confidentiality

8.1 Non-use and Nondisclosure Obligations.

(a) Each Party agrees not to use Confidential Information (as hereinafter
defined) furnished by the other Party for any purpose other than for purposes of
performing its obligations under this Agreement.  Each Party shall treat
Confidential Information furnished by the other Party with the same degree of
care as it treats its own proprietary information, but in any case, with no less
degree than reasonable care and shall not disclose the same, for a period of
[***] ([***]) years after the Effective Date of this Agreement or [***] ([***])
years following the expiration or earlier termination of this Agreement,
whichever is [***], to any Third Party without the prior written consent of the
Party which furnished such information.

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(b) If, to carry out its obligations under this Agreement, a Party must disclose
Confidential Information of the other Party to a Third Party, such disclosing
Party shall first require any such Third Party to be bound by the
confidentiality provisions of this Agreement by requiring such Third Party to
enter into an appropriate written confidentiality agreement.  This provision
shall not be applicable to confidential information disclosed by the Parties
pursuant to Section 8.2.

8.2 Confidential Information.  A Party’s “Confidential Information” refers to
all information disclosed to the other Party or its Affiliates, on or after the
Effective Date, pursuant to this Agreement, including, for Relypsa, non-public
information relating to the [***] of the Product, and including, for Sanofi,
[***].  Notwithstanding the foregoing or any other provision in this Agreement
to the contrary, a Party’s Confidential Information shall not include:

(a) information which at the time of disclosure is in the public domain or
thereafter becomes part of the public domain through no breach of this Agreement
by the receiving Party;

(b) information which the receiving Party can establish by competent written
proof was in its possession at the time of disclosure by the disclosing Party
and was not acquired, directly or indirectly, from the disclosing Party;

(c) information which becomes available to the receiving Party, or its
Affiliate, from an independent third source not bound by an obligation of
secrecy to the Disclosing Party with respect to the Confidential Information,
effective as of the time such information is properly disclosed; or

(d) information which the receiving Party can establish by competent written
proof was independently developed by the receiving Party without the reference
to or any other use of the disclosing Party’s Confidential Information.

8.3 Disclosure Required by Law.  Notwithstanding anything else in this
Agreement, the receiving Party shall not be prohibited from disclosing
Confidential Information of the disclosing Party to the extent such information
is required to be disclosed to governmental agencies or by legal process or
Applicable Laws, in which case the receiving Party shall notify the disclosing
Party in writing of the need for such disclosure and shall cooperate with the
disclosing Party to seek confidential treatment of the information.

8.4 Remedies.  The receiving Party agrees that its obligations under this
Article 0 are necessary and reasonable to protect the disclosing Party’s
business interests and that the failure to comply with this Article 0 could
cause irreparable harm and significant injury, the degree of which may be
difficult to ascertain.  The receiving Party further acknowledges and agrees
that in the event of any actual or threatened breach of this Agreement, the
disclosing Party may have no adequate remedy at law and, accordingly, that the
disclosing Party shall have the right to seek an immediate injunction enjoining
any breach or threatened breach of this Agreement, as well as the right to
pursue any and all other rights and remedies available at law or in equity for
such breach or threatened breach.

8.5 Return of Confidential Information.  Upon termination of this Agreement and
upon the request of the disclosing Party, the receiving Party shall return all
such Confidential Information and copies thereof in its possession; provided,
however, that one (1) copy of the disclosing Party’s Confidential Information
may be retained by the legal department of the receiving Party solely for the
purpose of determining compliance with this Article 8.

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8.6 Disclosure of Agreement, Publicity and Publications.  The terms of this
Agreement shall be deemed the Confidential Information of both Parties.  Except
as expressly provided otherwise in this Article 0, neither Relypsa nor Sanofi
shall release to any Third Party or publish in any way any non-public
information with regard to the terms of this Agreement or concerning their
cooperation without the prior written consent of the other, which consent shall
not be unreasonably withheld, conditioned or delayed.  Subject to the foregoing,
Relypsa shall issue a press release, public statement or disclosure regarding
this Agreement substantially in the form of the press release attached as
Exhibit H.

9. Representations, Warranties and Covenants

9.1 Mutual Representations and Warranties and Covenants.  As of the Effective
Date, each of Relypsa and Sanofi hereby represents, warrants and covenants to
the other Party that:

(a) it is a corporation or entity duly organized and validly existing under the
laws of the State or other jurisdiction of its incorporation or formation;

(b) the execution, delivery and performance of this Agreement by such Party has
been duly authorized by all requisite corporate action and does not require any
shareholder action or approval;

(c) it has the power and authority to execute and deliver this Agreement and to
perform its obligations hereunder and this Agreement constitutes and when
executed shall constitute, its legal, valid and binding obligation, enforceable
in accordance with its terms, except as may be limited by bankruptcy and
equitable principles limiting specific performance;

(d) the execution, delivery and performance by such Party of this Agreement and
its compliance with the terms and provisions hereof does not and shall not
conflict with or result in a breach of any of the terms and provisions of or
constitute a default under: (i) a loan agreement, guaranty, financing agreement,
agreement affecting a product or other agreement or instrument binding or
affecting it or its property; (ii) the provisions of its charter or operative
documents or bylaws; or (iii) any order, writ, injunction or decree of any court
or governmental authority entered against it or by which any of its property is
bound; and

(e) during the Term, it and its Affiliates shall comply with Applicable Law in
connection with its activities hereunder.

(f) Each Party represents, warrants and covenants that such Party has not
entered into, and will not during the Term enter into, any agreements with any
Third Party that conflicts with the rights granted to the other Party, or would
prevent such Party from performing its obligations, pursuant to this Agreement
in any material respect.

(g) Each Party represents to the other that neither it nor its employees or
contractors performing services with respect to the Product are currently
excluded, debarred, suspended or otherwise ineligible to participate in the
Federal health care programs or in Federal procurement or nonprocurement
programs, or has been convicted of a criminal offense that falls within the
ambit of 42 U.S.C. 1320a-7(a) and that could reasonably result in such Party or
individual being excluded, debarred, suspended or otherwise declared
ineligible.  Each Party further represents that it has policies to screen all
prospective employees and contractors prior to engaging their services and
determine whether any existing employee or contractor becomes excluded,
debarred, suspended or otherwise declared ineligible.  Each Party has policies
and procedures in

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effect that require, and it shall otherwise require, all employees and
contractors to immediately disclose to such Party  any action or event that
could reasonably result in such employee or contractor becoming so excluded,
debarred, suspended or otherwise declared ineligible.  In addition, each Party
shall maintain during the Term a compliance program designed to prevent and
detect violations of Applicable Laws in connection with this Agreement,
including such violations relating to their respective activities hereunder,
which program shall be designed in a manner consistent with the Compliance
Program Guidance for Pharmaceutical Manufacturers issued in April 2003 by the
HHS Office of Inspector General.  Further, each Party agrees that it will cause
its respective PSRs performing activities in the Territory with respect to the
Product to act in accordance with industry standards, including the
Pharmaceutical Research and Manufacturers of America Code on Interactions with
Healthcare Professionals and the American Medical Association’s Guidelines on
Gifts to Physicians (in each case, including any updated therefor), and in a
professional, ethical and lawful manner generally consistent with the manner in
which such Party promotes other products in the Territory.

9.2 Relypsa Representations and Warranties and Covenants.  As of the Effective
Date, Relypsa hereby represents, warrants and covenants to Sanofi that:

(a) Relypsa controls all intellectual property claiming or covering the Product
necessary for each Party to perform its obligations under this Agreement in the
Territory.

(b) There is no [***] by the activities contemplated herein with respect to the
Product.  Relypsa has not [***] that the commercialization of the Product in the
Territory as contemplated herein [***] owned or control by any Third Party.

(c) No Person has asserted in writing that any [***] are [***] [***], in whole
or in part.  To Relypsa’s knowledge, [***].

(d) The information for the Product submitted to the FDA in or in connection
with the NDA for regulatory approval for the Product represents, in all material
respects, an accurate reflection of all material information known to Relypsa
that is relevant to the safety and efficacy profile of the Product.

9.3 DISCLAIMER.  EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT, EACH PARTY
HEREBY DISCLAIMS ALL OTHER WARRANTIES, WHETHER WRITTEN OR ORAL, EXPRESS AND
IMPLIED, INCLUDING THE IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE OR FREEDOM FROM INFRINGEMENT OF THIRD PARTY RIGHTS.

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10. Indemnification, Liability Limits and Insurance.

10.1 Indemnification by Sanofi.  Subject to Section 10.3, Sanofi shall
indemnify, defend and hold Relypsa, and its officers, directors, agents,
employees, and Affiliates (collectively, the “Relypsa Indemnitees”), harmless
from any and all losses, damages, liabilities, costs and expenses (including
reasonable attorneys’ fees incurred hereunder) (collectively, “Losses”) in
connection with any and all claims, causes of action, investigations or actions
of Third Parties (collectively, “Third Party Claims”) arising out of or in
connection with: (a) the breach by Sanofi of any of its representations,
warranties, covenants or obligations under this Agreement; or (b) any
negligence, gross negligence or willful misconduct of any Sanofi Indemnitee
under this Agreement, except, in each case, to the extent such Third Party
Claims arise out of or in connection with any circumstance set forth in Section
0 of this Agreement, but in no event shall Sanofi be liable under this Section 0
for use of any promotional or training materials provided by Relypsa to Sanofi
hereunder that are used by Sanofi in accordance with this Agreement.

10.2 Indemnification by Relypsa.  Subject to Section 0, Relypsa shall indemnify,
defend and hold Sanofi, and its officers, directors, agents, employees, and
Affiliates (collectively, the “Sanofi Indemnitees”), harmless from any Losses in
connection with any and all Third Party Claims arising out of or in connection
with: (a) the breach by Relypsa of any of its representations, warranties,
covenants or obligations under this Agreement; (b) the [***], including any
[***], any Third Party Claims arising out of or in connection with any [***] in
connection with the Marketing, advertising or sale of the Product (including
training materials and Product Promotional and Educational Materials), (c) any
claim that the [***], or (d) any negligence, gross negligence or willful
misconduct of any Relypsa Indemnitee under this Agreement, except in each case
to the extent such Third Party Claims arise out of any circumstance set forth in
Section 0 of this Agreement.

10.3 Procedure.  A Party’s obligation to defend, indemnify and hold harmless the
other Party under this Article 11 shall be conditioned upon the following:

(a) A Party seeking indemnification under this Article 0 (the “Indemnitee”)
shall give prompt written notice of the claim to the other Party (the
“Indemnitor”).

(b) Each Party shall furnish promptly to the other Party, copies of all papers
and official documents received in respect of any Third Party Claims.  The
Indemnified Party shall cooperate as reasonably requested by the Indemnifying
Party in the defense against any Third Party Claims.

(c) The Indemnitor shall have the right to assume and control the defense of the
indemnification claim at its own expense with counsel selected by the Indemnitor
and reasonably acceptable to the Indemnitee, except that an Indemnitee shall
have the right to retain its own counsel, with the fees and expenses to be paid
by the Indemnitee, if representation of such Indemnitee by the counsel retained
by the Indemnitor would be inappropriate due to actual or potential differing
interests between such Indemnitee and any other party represented by such
counsel in such proceedings.  If the Indemnitor does not assume the defense of
the indemnification claim as described in this Section 0, the Indemnitee may
defend the indemnification claim but shall have no obligation to do so.  The
Party controlling such action shall not settle or compromise the indemnification
claim in any manner that would: (i) require any payment by the other Party; (ii)
require an admission of legal wrongdoing in any way by the other Party; or (iii)
effect an amendment of this Agreement, in each case without the prior written
consent of the other Party, which consent shall not be unreasonably withheld,
delayed or conditioned.  The Indemnitee shall reasonably cooperate with the
Indemnitor at the

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Indemnitor’s expense and shall make available to the Indemnitor all pertinent
information under the control of the Indemnitee, which information shall be
subject to Article 0.

(d) The Indemnitee shall not settle or compromise any Third Party Claim without
the prior written consent of the Indemnitor.  The Indemnitor shall not be liable
for any settlement or other disposition of Third Party Claims by the Indemnitee
which is reached without the written consent of the Indemnitor, which consent
shall not be unreasonably withheld, conditioned, or delayed.

10.4 Limitations of Liability.

(a) SUBJECT TO SECTION 10.4(c), NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY
FOR SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE, OR CONSEQUENTIAL DAMAGES (INCLUDING
DAMAGES RESULTING FROM LOSS OF USE, LOSS OF PROFITS, INTERRUPTION OR LOSS OF
BUSINESS, OR OTHER ECONOMIC LOSS) ARISING OUT OF THIS AGREEMENT OR WITH RESPECT
TO A PARTY’S PERFORMANCE OR NON-PERFORMANCE HEREUNDER.

(b) SUBJECT TO SECTION 10.4(c), SANOFI’S AGGREGATE LIABILITY TO RELYPSA UNDER OR
IN RELATION TO THIS AGREEMENT SHALL BE LIMITED TO THE [***] UNDER THIS ARTICLE
10.

(c) The limitations set forth in Section 0 shall not apply with respect to: (i)
damages required to be paid to a Third Party as part of a Third Party Claim for
which a Party provides indemnification under Section 0 or Section 0; or (ii)
breach of a Party’s obligations under Article 0 or a Party’s payment obligations
under this Agreement.

(d) Relypsa’s sole and exclusive remedies for Sanofi’s failure to achieve the
Expected Details in any given [***] shall be, if applicable, (i) Sanofi’s
failure to receive the Product Incentive Payment for such [***] pursuant to
Section 0 and (ii) the right of Relypsa to terminate this Agreement pursuant to
and in accordance with Section 0.

10.5 Insurance.  Each Party shall carry commercial general liability insurance
against claims judgments, liabilities and expenses for which it is obligated to
indemnify the other Party under this Article 0, in such amounts and with such
deductibles as are customary at the time for companies engaged in a similar
business.  Each Party shall use Commercially Reasonable Efforts to provide the
other Party with [***] ([***]) days prior written notice of any material
modification of its insurance policy.

11. Term and Termination

11.1 Term.  The term of this Agreement (the “Term”) shall commence as of the
Effective Date and shall expire at the end of the Commitment Term, unless
earlier terminated pursuant to Section 0.

11.2 Termination Rights.

(a) Material Breach.  If a Party materially breaches this Agreement, and such
material breach is not cured within [***] ([***]) days (with respect to a breach
of a Party’s payment obligations hereunder) or [***] ([***]) days (with respect
to all other obligations hereunder), as applicable, after receipt of

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notice thereof from the other Party, the non-breaching Party shall be entitled
to terminate this Agreement by giving written notice to the other Party, such
termination to take effect immediately on receipt of such notice.

(b) Failure to Meet the Sanofi Minimum Details Commitment.  If Sanofi fails to
perform the Sanofi Minimum Details Commitment during any [***] following First
Commercial Sale, then Relypsa shall be entitled to terminate this Agreement by
giving written notice to Sanofi, such termination to take effect [***] receipt
of such notice.

(c) Regulatory Approval Delay.  Either Party shall have the right to terminate
this Agreement (i) [***] ([***]) days after the PDUFA Date if Relypsa receives a
[***] from the FDA that is [***] within [***] ([***]) months from the PDUFA
Date, or (ii) if Relypsa has not obtained regulatory approval from the FDA to
sell the Product in the Territory on or before [***].

(d) Product Safety.  Either Party shall have the right to terminate this
Agreement upon notice to the other Party, if the Product is permanently
withdrawn from the Territory for safety reasons, such termination to take effect
immediately on receipt of such notice.

(e) [***].  [***] may terminate this Agreement if [***] is found to be or deemed
a “[***]” or “[***]” for purposes of any [***] that is binding upon [***].  Any
such termination shall be effective [***] ([***]) days after the receipt of
written notice of such termination by [***], unless [***] is found or no longer
deemed to be a “[***]” or “[***]” for purposes of such [***] prior to expiration
of such [***] ([***]) day period.

(f) Convenience.  Beginning on the first anniversary of the date of First
Commercial Sale in the Territory, either Party shall have the right to terminate
this Agreement without cause upon providing at least [***] ([***]) days’ prior
written notice to the other Party.

(g) Mutual Agreement.  This Agreement may be terminated at any time by mutual
written consent of the Parties.

(h) Bankruptcy or Insolvency.  Either Party shall have the right to terminate
this Agreement if the non-notifying Party becomes insolvent or makes an
assignment for the benefit of creditors, or if bankruptcy or insolvency
proceedings are instituted against the non-notifying Party or on the
non-notifying Party’s behalf, such termination to take effect immediately on
receipt of such notice.

(i) [***].   Sanofi shall have the right to terminate this Agreement by written
notice to Relypsa if [***], such termination to take effect [***] ([***]) days
after receipt of such [***].

11.3 Effect of Termination.  Upon any termination or expiration of this
Agreement, Sanofi shall immediately cease any and all Promotion of the Product,
and Sanofi shall promptly, at Relypsa’s election, destroy (at [***] cost and
expense), or shall cooperate with Relypsa in the collection and return to
Relypsa (at [***] cost and expense) of, all Product Promotional and Educational
Materials, scientific literature relating to the Product, and other sales or
sales training materials in the possession of Sanofi, any Sanofi PSR, Sanofi
Regional Business Director or any member of Sanofi’s Sales Management Team, as
promptly as practical after the date thereof.  Upon any such termination, all
licenses granted to Sanofi under this Agreement will immediately be terminated.

26

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

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EXECUTION VERSION

 

11.4 No Waiver of Remedies.  Termination of this Agreement shall not preclude
either Party from: (a) claiming any other damages, compensation or relief that
it may be entitled to upon such termination; (b) any right to receive any
amounts accrued under this Agreement prior to the termination date but which are
unpaid or become payable thereafter; and (c) any right to obtain performance of
any obligation provided for in this Agreement which shall survive termination.

11.5 Survival of Certain Provisions.  Termination or expiration of this
Agreement for any reason shall terminate all outstanding obligations and
liabilities between the Parties arising out of this Agreement, except those
described in:  Article 0, Section 0, Section 0, Section 0, Section 0, Section 0
(first sentence), Section 6.1(a)(i) (with respect to Details performed during
the Term), Section 0 (to the extent described in Section 0), Section 0, Section
0, Section 0, Section 0, Article 0, Section 9.3, Article 0, Section 0, Section
0, Section 0, and Article 0, all of which shall survive termination or
expiration of this Agreement for the time specified in such Articles and
Sections; provided, however, that if no such time period is specified in such
Articles and Sections, they shall all survive termination or expiration of this
Agreement indefinitely.

12. Miscellaneous

12.1 Integration.  This Agreement by and between the Parties hereto, is both a
final expression of the Parties’ agreement and a complete and exclusive
statement with respect to all of its terms.  The Exhibits and Recitals referred
to in this Agreement are incorporated herein and made a part of this Agreement
by this reference.  This Agreement supersedes all prior and contemporaneous
agreements and communications, whether oral, written or otherwise, concerning
any and all matters contained herein (except that certain Confidential
Disclosure Agreement between the Parties dated June 21, 2013, with all
information exchanged between the Parties after the Effective Date subject to
Article 0 hereof.

12.2 Relationship Between the Parties.  The Parties have no ownership interest
in the other and their relationship, as established by this Agreement, is solely
that of independent contractors.  This Agreement does not create any
partnership, joint venture or similar business relationship between the
Parties.  Neither Party is a legal representative of the other Party, and
neither Party can assume or create any obligation, representation, warranty or
guarantee, express or implied, on behalf of the other Party for any purpose
whatsoever.

12.3 Modification & Non-Waiver.  This Agreement may only be modified or waived
in a document that expressly states the Article or Section that is being
modified or waived and that is signed by the Parties.  The failure of a Party to
insist upon strict performance of any provision of this Agreement or to exercise
any right arising out of this Agreement shall neither impair that provision or
right nor constitute a waiver of that provision or right, in whole or in part,
in that instance or in any other instance.

12.4 Assignment.  This Agreement is binding upon and inures to the benefit of
the Parties, and to their permitted successors and assigns.  No Party may assign
or delegate any or all of its rights or obligations under this Agreement to any
Person without the prior written consent of the other Party (not to be
unreasonably withheld, delayed or conditioned), except that either Party may
assign this Agreement without the prior written consent of the other Party to an
Affiliate of the assigning Party or in connection with a merger, acquisition or
sale of substantially all of the business or assets to which the Agreement
relates.  Any assignment or delegation, or any other transfer or change of
control by sale, acquisition, merger, or otherwise, or attempt at the same, made
in the absence of such prior written consent shall be null and void.

27

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

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EXECUTION VERSION

 

12.5 No Third Party Beneficiaries.  This Agreement is neither expressly nor
impliedly made for the benefit of any Party other than the Parties, the Relypsa
Indemnitees and the Sanofi Indemnitees, and there are no intended third party
beneficiaries except for the Relypsa Indemnitees and the Sanofi Indemnitees.

12.6 Severability.  Whenever possible, each provision of this Agreement shall be
interpreted in such manner as to be effective and valid under Applicable Laws,
but if any provision of this Agreement is held to be prohibited by or invalid
under Applicable Laws, such provision shall be ineffective only to the extent of
such prohibition or invalidity, without invalidating the remainder of this
Agreement.  If such invalidity arises, the Parties shall seek to agree on an
alternative enforceable provision that preserves the original purpose of this
Agreement.

12.7 Notices.  All notices or consents given under this Agreement shall be in
writing, addressed to the Parties at the following addresses, and delivered by
person, by facsimile (with receipt confirmation and promptly confirmed by
personal delivery or courier), or by next Business Day delivery service of a
nationally recognized  overnight courier service.  Any such notice shall be
deemed to have been given upon receipt by the addressee.  Unless otherwise
specified in writing, the mailing addresses of the Parties shall be as described
below shall be either delivered to the intended recipient in person, by prepaid
security post or by facsimile transmission to the address or  facsimile number
below or the address or facsimile number last notified by the intended
recipient.

If to Relypsa, notices must be addressed to:

Relypsa, Inc.

100 Cardinal Way

Redwood City, CA 94063

Attention:  [***]

Facsimile: [***]

With a copy to:

Latham & Watkins, LLP

140 Scott Drive

Menlo Park, CA 94025

Attention:  Judith Hasko

Facsimile: 650-463-2600

If to Sanofi, notices must be addressed to:

sanofi-aventis US LLC

55 Corporate Drive

Bridgewater, NJ 08807

Attention:  [***]

28

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

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EXECUTION VERSION

 

with a copy to:

Covington & Burling LLP

One Front Street

San Francisco, CA 94111

Attention:  Amy Toro

Facsimile: [***]

12.8 Compliance with Laws.  Notwithstanding any other provision of this
Agreement to the contrary, nothing in this Agreement will require either Party
to engage in any activity or use any materials that could violate Applicable Law
or that such Party believes could violate its internal policies and procedures,
compliance program controls, or any Corporate Integrity Agreement or other
agreement with a governmental entity governing its operations in the Territory.

12.9 Force Majeure.  Each Party shall be excused from liability for the failure
or delay in performance of any obligation under this Agreement (other than an
obligation to make payments due and payable under this Agreement) to the extent
such failure or delay is caused by or results from causes beyond the reasonable
control of the affected Party, including acts of God, war, civil unrest, fire,
flood, explosion, earthquake, or other natural forces (a “Force Majeure
Event”).  Such excuse from liability shall be effective only to the extent and
duration of the event(s) causing the failure or delay in performance and
provided that the Party so affected shall use commercially reasonable efforts to
avoid or remove or mitigate such causes of non-performance, and continues
performance with reasonable dispatch whenever such causes are removed.  Notice
of a Party’s failure or delay in performance due to a Force Majeure Event must
be given to the other Party within [***] ([***]) days after its occurrence.  All
delivery dates under this Agreement that have been affected by a Force Majeure
Event shall be tolled for the duration of such Force Majeure
Event.  Notwithstanding the foregoing, if the Force Majeure Event(s) suffered by
a Party extend beyond a [***] ([***]) month period, the other Party may then
terminate this Agreement by written notice to the non-performing Party.

12.10 Dispute Resolution.  Except with regard to any matters or disputes between
the Parties for which Relypsa has final decision-making authority pursuant to
Section 0, if a dispute or controversy regarding any other matter under this
Agreement, arises between the Parties which they are unable to resolve (a
“Dispute”), each of the Parties shall (subject to any applicable cure period as
set forth in this Agreement), be entitled to submit to the other Party written
notice of such Dispute, with such notice setting forth in reasonable detail the
nature of the Dispute (the “Dispute Notice”).  For a period of [***] ([***])
days after the date of the receiving Party’s receipt of the Dispute Notice, the
Parties shall seek to resolve such Dispute by good faith negotiation between the
Parties’ Senior Executive Officers.  If at the end of such [***] ([***]) day
period the Dispute remains unresolved, the Parties may seek relief for such
Dispute using any appropriate administrative or judicial mechanism which may be
available, subject to Section 0.  The provisions of this Section 0 shall not
restrict in any way the Parties’ rights to seek preliminary injunctive or other
equitable relief from any court having jurisdiction.

 

 

 

29

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

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EXECUTION VERSION

 

12.11 Jurisdiction and Governing Law.  Notwithstanding its place of execution or
performance, this Agreement shall be governed by and construed in accordance
with the laws of the State of New York, irrespective of its laws regarding
choice or conflict of laws.  The Parties hereby agree that for the purposes of
resolving any Disputes hereunder, in accordance with Section 0, that the Parties
hereby submit to the exclusive jurisdiction of the courts of New York.

12.12 Interpretation.  The captions and headings of Articles and Sections
contained in this Agreement are inserted solely for convenience and ease of
reference only and shall not constitute any part of this Agreement, or have any
effect on its interpretation or construction.  All references in this Agreement
to the singular shall include the plural where applicable, and all references to
gender shall include both genders and the neuter.  Unless otherwise specified,
references in this Agreement to any Article shall include all Sections,
subsections, and paragraphs in such Article; references in this Agreement to any
Section shall include all subsections and paragraphs in such sections; and
references in this Agreement to any subsection shall include all paragraphs in
such subsection.  The word “including” or any variation thereof means “including
without limitation” and the word “including” or any variation thereof shall not
be construed to limit any general statement which it follows to the specific or
similar items or matters immediately following it.  The term “or” has, except
where otherwise indicated, the inclusive meaning represented by the phrase
“and/or”.  Ambiguities and uncertainties in this Agreement, if any, shall not be
interpreted against either Party, irrespective of which Party may be deemed to
have caused the ambiguity or uncertainty to exist.  No trade customs, courses of
dealing or courses of performance by the Parties shall be relevant to modify,
supplement or explain any term(s) used in this Agreement.

12.13 Counterparts.  This Agreement may be executed in one (1) or more
counterparts, each of which shall be deemed an original document, and all of
which, together with this writing, shall be deemed one instrument. An executed
signature page of this Agreement delivered by facsimile transmission or by
electronic mail in “portable document format” (“.pdf”) shall be as effective as
an original executed signature page.

12.14 Further Assurances.  Each Party to this Agreement shall, at its own
expense, furnish, execute, and deliver all documents and take all actions as may
reasonably be required to effect the terms and purposes of this Agreement.

[Signatures on next page]

 

 

 

30

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EXECUTION VERSION

 

The Parties hereto have caused this Agreement to be executed by their duly
authorized officers as of the day and year written below.  The Parties
acknowledge that the signature date may not be the Effective Date.

 

Sanofi-Aventis US  LLC

 

Relypsa, Inc.

 

 

 

 

 

 

 

By:

 

/s/ Nicholas Grund

 

By:

 

/s/ John A. Orwin

 

 

 

 

 

 

 

Name:

 

Nicholas Grund

 

Name:

 

John A. Orwin

 

 

 

 

 

 

 

Title:

 

SVP, Head of Specialty Care

 

Title:

 

President & CEO

 

 

 

 

 

 

 

Date:

 

8/10/2015

 

Date:

 

 

 

By:

 

 

 

 

 

Name:

 

 

 

 

 

Title:

 

 

 

 

 

Date:

 

 

 

 

 

[SIGNATURE PAGE]

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EXECUTION VERSION

 

Exhibit A

INITIAL SALES PROGRAM PLAN FOR THE PRODUCT

[***]

Exhibit A Page 1 of 4

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

EXECUTION VERSION

 

[***]

Exhibit A Page 2 of 4

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

EXECUTION VERSION

 

[***]

Exhibit A Page 3 of 4

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

EXECUTION VERSION

 

[***].

 

 

 

Exhibit A Page 4 of 4

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

EXECUTION VERSION

 

Exhibit B

SALES FORCE INCENTIVE PLAN

Following the Effective Date,  [***] in accordance with its policies and
procedures governing [***]:

[***]

 

 

 

Exhibit B Page 1 of 1

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

EXECUTION VERSION

 

Exhibit C

TECHNICAL AGREEMENTS

To be finalized within [***] ([***]) days after the Effective Date.

 

 

 

Exhibit C Page 1 of 1

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

EXECUTION VERSION

 

Exhibit D

FORM OF SERVICE FEE INVOICE

[***]

 

 

 

Exhibit D Page 1 of 1

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

EXECUTION VERSION

 

Exhibit E

FORM OF [***]

 

 

Relypsa, Inc.

 

[***]

 

 

 

 

 

 

 

 

 

 

 

 

 

Exhibit E Page 1 of 1

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

EXECUTION VERSION

 

Exhibit F

FORM OF [***]

 

[***]

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exhibit F Page 1 of 1

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

EXECUTION VERSION

 

Exhibit G

[***] DETAIL REPORT

 

§  Total number of details performed by [***]

§  Aggregate detail activity for [***]

 

 

 

Exhibit G Page 1 of 1

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.

--------------------------------------------------------------------------------

EXECUTION VERSION

 

Exhibit H

PRESS RELEASE

 

[g20151104205506804581.jpg]

NEWS RELEASE

 

Contact:

Charlotte Arnold

Vice President, Corporate Communications

650.421.9352

IR@relypsa.com

RELYPSA ENTERS two-year DETAILING AGREEMENT WITH SANOFI IN THE

UNITED STATES

REDWOOD CITY, Calif., August 10, 2015 – Relypsa Inc. (NASDAQ: RLYP), a
biopharmaceutical company, today announced it has entered a two-year detailing
agreement with Sanofi for Patiromer for Oral Suspension (Patiromer
FOS).  Patiromer FOS is Relypsa’s investigational medicine that is currently
under review for the treatment of hyperkalemia with the U.S. Food and Drug
Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) action date
of October 21, 2015.

Relypsa intends to commercialize Patiromer FOS, if approved, with its own
dedicated U.S.-based commercial team and specialty sales force of approximately
120 sales representatives.  Relypsa’s sales force will focus primarily on
outreach to nephrologists, cardiologists and hospitals.  Under the terms of the
agreement, Sanofi’s nephrology sales force will complement Relypsa’s efforts by
detailing Patiromer FOS in the United States for a two-year period.  During the
term of the agreement, Sanofi will be paid a service fee and is also eligible to
receive incentive payments.  The term may be extended by mutual agreement of
both parties.  

Relypsa will continue to be responsible for all regulatory, development,
commercial, manufacturing and distribution activities for Patiromer FOS in the
United States, including recording sales.  

“Hyperkalemia is a serious and potentially fatal medical complication. We are
continuing to work toward our goal of bringing hyperkalemia patients the first
new medicine in more than 50 years,” said John A. Orwin, president and chief
executive officer of Relypsa. “We believe this agreement will support a strong
start for Patiromer FOS in the United States, if approved.  Sanofi’s experienced
nephrology sales force can be mobilized immediately upon potential approval and,
combined with our own representatives, will enable more frequent and
comprehensive outreach to nephrologists and cardiologists.”

Exhibit H Page 1 of 3

Relypsa, Inc.  |  100 Cardinal Way, Redwood City, CA  94063  |  Tel:
650-421-9500  |  Fax: 650-421-9700  |  www.relypsa.com

--------------------------------------------------------------------------------

EXECUTION VERSION

 

“Sanofi is committed to helping people living with renal disease and is proud to
partner with Relypsa, a company that shares our commitment,” said Nik Grund,
senior vice president of the Specialty Care Division, Sanofi. “For nearly two
decades, Sanofi has served the nephrology community with our portfolio of renal
products and services.  This agreement has the potential to help us build upon
that legacy by bringing a new and innovative therapy to patients with
hyperkalemia.”

Conference Call Today at 5:00 PM ET (2:00 PM PT)

The Relypsa management team will host a teleconference and webcast to discuss
the partnership. The live call may be accessed by phone by calling (866)
410-4428 (domestic) or (704) 908-0287 (international), conference code 8382449.
The webcast may be accessed live on the investor relations section of the
Relypsa website at investor.relypsa.com and will be archived for 30 days
following the call.

About Patiromer for Oral Suspension

Patiromer FOS is an oral potassium binder in development for the treatment of
hyperkalemia. This investigational medicine has been studied in both treatment
and prevention studies, primarily in patients with chronic kidney disease (CKD),
also heart failure, patients with both, and those with diabetes and
hypertension. The clinical program includes a two-part pivotal Phase 3 program
conducted under Special Protocol Assessment with FDA, a 12-month Phase 2 trial
and a 48-hour Phase 1 onset-of-action trial.

About Hyperkalemia

Hyperkalemia, or abnormally elevated levels of potassium in the blood, is a
condition which can lead to life-threatening cardiac arrhythmia and sudden
death. It is frequently prevalent in patients who suffer from CKD, hypertension,
diabetes and/or heart failure. Patients with CKD or heart failure are at
particular risk for developing hyperkalemia, especially those treated with
renin-angiotensin-aldosterone-system (RAAS) inhibitors, which can increase blood
potassium levels in patients taking these medicines.

About Relypsa, Inc.

Relypsa, Inc. is a biopharmaceutical company focused on the development and
commercialization of non-absorbed polymeric drugs to treat disorders in the
areas of renal, cardiovascular and metabolic diseases. The company's two-part
pivotal Phase 3 trial of its lead product candidate, Patiromer for Oral
Suspension, has been completed and the primary and secondary endpoints were met.
A New Drug Application for Patiromer for Oral Suspension for the treatment of
hyperkalemia was accepted by the U.S. Food and Drug Administration and is
currently under review. Relypsa has global royalty-free commercialization rights
to Patiromer for Oral Suspension, which has intellectual property protection in
the United States until at least 2030. More information is available at
www.relypsa.com.

About Sanofi

Sanofi, a global healthcare leader, discovers, develops and distributes
therapeutic solutions focused on patients’ needs. Sanofi has core strengths in
diabetes solutions, human vaccines, innovative drugs, consumer healthcare,
emerging markets, animal health and Genzyme. Sanofi is listed in Paris
(EURONEXT: SAN) and in New York (NYSE: SNY).

Exhibit H Page 2 of 3

Relypsa, Inc.  |  100 Cardinal Way, Redwood City, CA  94063  |  Tel:
650-421-9500  |  Fax: 650-421-9700  |  www.relypsa.com

--------------------------------------------------------------------------------

EXECUTION VERSION

 

Forward-Looking Statements Related to Relypsa, Inc.

To the extent that statements contained in this press release are not
descriptions of historical facts regarding Relypsa, they are forward-looking
statements reflecting the current beliefs and expectations of management made
pursuant to the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995, including statements regarding the potential for, and timing
of, approval and commercialization of Patiromer for Oral Suspension, or
Patiromer FOS, the expected impact of the agreement with Sanofi, the therapeutic
and commercial potential of Patiromer FOS, Relypsa’s commercial launch plans and
the potential Prescription Drug User Fee Act action date. Such forward-looking
statements involve substantial risks and uncertainties that could cause our
clinical development program, future results, performance or achievements to
differ significantly from those expressed or implied by the forward-looking
statements. Such risks and uncertainties include, among others, the
uncertainties inherent in the clinical drug development process, including the
regulatory approval process, the timing of Relypsa's regulatory filings,
Relypsa's substantial dependence on Patiromer FOS, Relypsa's commercialization
plans and efforts and other matters that could affect the availability or
commercial potential of Patiromer FOS. Relypsa undertakes no obligation to
update or revise any forward-looking statements. For a further description of
the risks and uncertainties that could cause actual results to differ from those
expressed in these forward-looking statements, as well as risks relating to the
business of Relypsa in general, see Relypsa's current and future reports filed
with the U.S. Securities and Exchange Commission, including its Annual Report on
Form 10-K for the year ended December 31, 2014, and its Quarterly Report on Form
10-Q for the quarterly period ended June 30, 2015.

###

 

 

 

Exhibit H Page 3 of 3

Relypsa, Inc.  |  100 Cardinal Way, Redwood City, CA  94063  |  Tel:
650-421-9500  |  Fax: 650-421-9700  |  www.relypsa.com

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EXECUTION VERSION

 

EXHIBIT I

SANOFI EXPENSES PER DETAIL

[***]

 

Exhibit I Page 1 of 1

[***] Certain information in this document has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.