Exhibit 10.1

[***] 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.

Confidential

Execution Copy  

LICENSE AGREEMENT

This License Agreement (the “Agreement”) is effective as of August 10, 2015 (the
“Effective Date”) between Relypsa, Inc., a Delaware corporation located at 100
Cardinal Way, Redwood City, CA 94063, USA (“Relypsa”), and Vifor Fresenius
Medical Care Renal Pharma Ltd., a corporation that is established in accordance
with Swiss laws and registered in the commercial registry under
CH-320.3.033.350-1 and that is located at Rechenstrasse 37, CH-9014 St. Gallen,
Switzerland (“VFMCRP”).  Relypsa and VFMCRP are referred to individually as a
“Party” and collectively as the “Parties.”

RECITALS

Whereas, Relypsa is a biopharmaceutical company focused on the development and
commercialization of non-absorbed polymeric drugs to treat renal, cardiovascular
and metabolic diseases, including the product known as Patiromer, a potassium
binding agent which has been developed for the treatment of hyperkalemia;

Whereas, VFMCRP is a pharmaceutical company engaged in the development and
commercialization of innovative and high quality products and therapies to
improve the life of patients suffering from chronic kidney disease worldwide;
and

Whereas, Relypsa is willing to grant to VFMCRP, and VFMCRP desires to obtain, a
license under Relypsa’s intellectual property rights to develop and
commercialize Patiromer in certain countries with product manufactured and
supplied by or on behalf of Relypsa, on the terms and conditions set forth in
this Agreement.

AGREEMENT

Now, Therefore, 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 1, or, if not listed in this Article 1, the meanings as designated
in the text of this Agreement.

1.1 “Affiliate” means a corporation, partnership, trust or other entity that
directly, or indirectly through one or more intermediates, controls, is
controlled by or is under common control with a specified Party.  For such
purposes, “control,” “controlled by” and “under common control with” shall mean
the possession of the power to direct or cause the direction of the management
and policies of an entity, whether through the ownership of voting equity,
voting member or partnership interests, control of a majority of the board of
directors or other similar body, by contract or otherwise.  In the case of a
corporation, the direct or indirect ownership of fifty percent (50%) or more of
its outstanding voting shares or the ability otherwise to elect a majority of
the board of directors or other managing authority of the entity shall in any
event be presumptively deemed to confer control, it being understood that the
direct or indirect ownership of a lesser percentage of such shares shall not
necessarily preclude the existence of control.

 

 

 

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1.2 “Alliance Manager” has the meaning set forth in Section 3.6(a).

1.3 “Applicable Laws” means all applicable laws, rules, and regulations,
including: (a) any rules, regulations, guidelines or other requirements of
Regulatory Authorities; and (b) the OECD Convention Against Bribery of Foreign
Public Officials in International Business Transactions, legislation
implementing such Convention or the U.S. Foreign Corrupt Practices Act, and any
other international anti-bribery convention or any other local anti-corruption
and bribery law, in each case that may be in effect from time to time in any
relevant legal jurisdiction in the Licensed Territory.

1.4 “Background [***] Technology” means all Information, Patents and Patent
Applications, to the extent relating to [***], that are Controlled by VFMCRP or
its Affiliates, either (a) on or before the Effective Date, or (b) after the
Effective Date to the extent developed solely by VFMCRP or its Affiliates;
provided however, in all cases Background [***] Technology shall not include
[***].  

1.5 “Bioequivalent” means, inside the United States, "therapeutically
equivalent" as evaluated by the FDA, applying the definition of "therapeutically
equivalent" set forth in the preface to the then-current edition of the FDA
publication "Approved Drug Products With Therapeutic Equivalence Evaluations"
and, outside the United States, such equivalent determination by the applicable
Regulatory Authorities as is necessary to permit pharmacists or other
individuals authorized to dispense pharmaceuticals under Applicable Law to
substitute one product for another product in the absence of specific
instruction from a physician or other authorized prescriber under Applicable
Law.

1.6 “Business Day” means any day other than a Saturday, Sunday or other day that
is a recognized national holiday in the U.S. or Switzerland 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 Zurich, Switzerland.

1.7 “Calendar Quarter” means the respective periods of three (3) consecutive
calendar months ending on March 31, June 30, September 30 and December 31.

1.8 “Calendar Year” means: (a) for the first Calendar Year of the Term, the
period beginning on the Effective Date and ending on December 31, 2015; (b) for
each Calendar Year of the Term thereafter, each successive period beginning on
January 1 and ending twelve (12) consecutive calendar months later on December
31; and (c) for the last Calendar Year of the Term, the period beginning on
January 1 of the Calendar Year in which the Agreement expires or terminates and
ending on the effective date of expiration or termination of this Agreement.

1.9 “Change of Control” means the occurrence of any of the following:

(a) A Party entering into a merger, consolidation, stock sale or sale or
transfer of all or substantially all of its assets, or other similar transaction
or several transactions with another entity, unless, following such transaction
or transactions: (i) the individuals and entities who were the beneficial owners
of the outstanding voting securities of such Party immediately prior to such
transaction or transactions beneficially own, directly or indirectly, at least
fifty percent (50%) of the combined voting power of the then outstanding voting
securities entitled to vote generally in the election of directors or similar
governing persons of the corporation or other entity resulting from such
transaction or transactions (“Successor”) in substantially the same proportions
as their ownership immediately prior to such transaction or transactions of such
outstanding voting securities; and (ii) at least fifty percent (50%) of the
members of the Board of Directors or similar governing body of the Successor

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were members of the Board of Directors of such Party at the time of the
execution of the initial agreement, or the action of the Board of Directors of
such Party, governing such transaction or transactions; or

(b) any transaction or series of transactions in which any person or entity or
group of persons or entities acquires beneficial ownership of securities of a
Party representing more than fifty percent (50%) of the combined voting power of
the then outstanding securities of such Party;

provided, however, that, notwithstanding subsections (a) or (b) above, neither
(x) a sale of a Party’s securities in an underwritten public offering of such
Party’s securities to multiple non-affiliated investors nor (y) any transaction
or series of related transactions principally for bona fide equity financing
purposes in which the issuing Party is the surviving corporation shall
constitute a Change of Control.

1.10 “Clinical Trials” means Phase I Clinical Trials, Phase II Clinical Trials,
Phase III Clinical Trials, Phase IV Clinical Trials, and/or variations of such
trials (e.g., Phase II/III).

1.11 “CMC” means the chemistry, manufacturing and controls portion of a
Regulatory Approval Application.

1.12 “Commercialization” means all activities undertaken relating to the
marketing and/or sale of the Product, including advertising, education,
planning, marketing, promotion, distribution and market and product
support.  “Commercialize” shall have a corresponding meaning.

1.13 “Commercialization Plan” has the meaning set forth in Section 6.3.

1.14 “Commercially Reasonable Efforts” means the performance of obligations or
tasks by a Party [***].  A Party’s Commercially Reasonable Efforts under this
Agreement shall be determined based [***].

1.15 “Competitive Product” means any product that:

(a) is marketed in a country in the Licensed Territory by one or more person(s)
or entity(ies) that is/are not an Affiliate or permitted sublicensee of VFMCRP;

(b) contains a Product or [***]; and

(c) is marketed in the Field.

1.16 “Confidential Information” has the meaning set forth in Section 14.1.

1.17 “Control” means, with respect to any item of Information or any Patent or
other intellectual property right, the right to grant a license or sublicense or
access with respect thereto as provided for in this Agreement, without violating
the terms of any agreement or other arrangement with, or any legal rights of, or
without requiring the consent of, any Third Party. Notwithstanding the
foregoing, for the purpose of defining whether the Information, Patent or other
intellectual property right is Controlled by a Party, if such Information,
Patent or other intellectual property right is first acquired, licensed or
otherwise made available to such Party after the Effective Date, and if the use,
practice or exploitation thereof by or on behalf of the other Party, its
Affiliates or sublicensees pursuant to the licenses and rights granted to such
other Party pursuant to this Agreement would require the first Party to [***]
such Information, Patent or other intellectual property rights, [***], such
Information, Patent or other intellectual property right shall be deemed to be
Controlled by the first Party only if [***] to such Information, Patent or other
intellectual property right.

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1.18 “Cost of Goods Sold” means the fully absorbed manufacturing costs
attributable to the manufacture of Products calculated in accordance with GAAP
[***], consistently applied, and includes, without limitation, the costs of
[***], all to the extent provided or procured in connection with the manufacture
of Products, or any components of the Products.  The Cost of Goods Sold includes
the foregoing categories of costs incurred in connection with the performance or
provision of [***].

1.19 “Current Good Manufacturing Practices” or “cGMP” means the regulations set
forth in 21 C.F.R. Parts 210–211, 820 and 21 C.F.R. Subchapter C (Drugs),
Quality System Regulations and the requirements thereunder imposed by the FDA,
and, as applicable, any similar or equivalent regulations and requirements in
jurisdictions outside the United States.

1.20 “Development” means all activities relating to obtaining or maintaining
Regulatory Approval of the Product, or Regulatory Approval of the Product for
additional indications, including, for example, preclinical testing, toxicology,
formulation, clinical studies, and regulatory affairs.  For clarity, the Parties
may continue to perform Development activities for the Product following the
First Commercial Sale of such Product to explore additional indications or
formulations of such Product, including, but not limited to, Phase IV Clinical
Trials.  “Develop” shall have a corresponding meaning.

1.21 “Development Plan” has the meaning set forth in Section 4.3(a).

1.22 “Distributor” means any Third Party (a) who is  [***], (b) whose role with
respect to Product in the Licensed Territory is [***]; and (d) in which
[***].  Distributors shall not include Wholesalers.  

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

1.24 “EMA” means the European Medicines Agency or any successor thereto, having
the administrative authority to regulate the marketing of human pharmaceutical
products, delivery systems and devices in European Union.

1.25 “EU” means the European Union, as its membership may be altered from time
to time, and any successor thereto.  The member countries of the European Union
as of the Effective Date are Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland,
Italy, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, and the United Kingdom.  

1.26 “Executives” means the [***] of Relypsa (or his designee), and the [***] of
VFMCRP (or his designee).

1.27 “Existing [***] Technology” means all Information, Patents and Patent
Applications that are Controlled by VFMCRP or its Affiliates, either (a) on or
before the Effective Date, (b) after the Effective Date to the extent (i) [***],
or (ii) [***] pursuant to this Agreement.  

1.28 “FDA” means the U.S. Food and Drug Administration, or any successor
thereto, having the administrative authority to regulate the marketing of human
pharmaceutical products, delivery systems and devices in the United States.

1.29 “Field” means the [***], including the treatment or prevention of
hyperkalemia in humans.

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1.30 “First Commercial Sale” means the first arm’s length commercial sale of a
Product VFMCRP, its Affiliates or their respective sublicensees, to a Third
Party for end use, including any final sale to a distributor or wholesaler in a
country in the Licensed Territory in which Regulatory Approval of such Product
has been obtained by VFMCRP or its Affiliates.

1.31 “Fresenius” means Fresenius Medical Care AG & Co KGaA, a corporation
organized and existing under the laws of Germany with an interest in VFMCRP as
of the Effective Date of [***] percent ([***]%).  For the purposes of this
Agreement, and notwithstanding anything to the contrary therein, [***].

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

1.33 “Good Clinical Practices” or “GCP” means the standards, practices and
procedures set forth in the guidelines entitled in “Good Clinical
Practice:  Consolidated Guideline,” including related regulatory requirements
imposed by the FDA and (as applicable) any equivalent or similar standards in
jurisdictions outside the United States.

1.34 “Good Laboratory Practices” or “GLP” means the regulations set forth in 21
C.F.R. Part 58 and the requirements expressed or implied thereunder imposed by
the FDA and, (as applicable) any equivalent or similar standards in
jurisdictions outside the United States.

1.35 “IFRS” means International Financial Reporting Standards.

1.36 “Indirect Taxes” means [***].

1.37 “Improvement” means any enhancement, modification or improvement of or to
[***], whether or not such enhancement, modification or improvement is
patentable, where the use of such enhancement, modification or improvement, in
the absence of the rights granted under the terms of this Agreement, would
infringe or misappropriate any of the intellectual property rights in [***].  

1.38 “Information” means ideas, inventions, discoveries, concepts, formulas,
practices, procedures, algorithm, processes, methods, knowledge, know-how, trade
secrets, technology, designs, drawings, computer programs, skill, experience,
documents, apparatus, results, clinical, business and regulatory strategies and
plans, test data, including pharmacological, toxicological and clinical data,
analytical and quality control data, engineering or manufacturing data and
descriptions, legal information and data, market data, financial data or
descriptions, devices, assays, chemical formulations, specifications,
compositions of matter, work in process, product samples and other samples,
physical, chemical and biological materials and compounds, and the like, in
written, oral, graphic, written, electronic or other form or provided by visual
inspection, whether now known or hereafter developed, and whether or not
patentable.

1.39 “Invention” shall mean any inventions arising during the Term and directly
in the course of the Parties’ performance under this Agreement that it or its
employees, Affiliates, licensees, permitted sublicensees, independent
contractors, consultants or agents solely or jointly make, conceive, reduce to
practice, author, or otherwise discover.

1.40 “Joint Development Committee” or “JDC” has the meaning set forth in Section
3.1.

1.41 “Joint Steering Committee” or “JSC” has the meaning set forth in Section
3.1.

1.42 “Licensed Territory” means the world, except for the U.S. and Japan.

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1.43 “Major Countries” means the [***].

1.44 “[***]” means [***].

1.45 “[***]” means [***].

1.46 “Marketing Authorization Holder” or “MAH” means the holder of a license or
the owner of a registration in each country in the Licensed Territory.

1.47 “Manufacturing and Supply Agreement” has the meaning set forth in Section
8.2.

1.48 “Marketing Authorization” or “MAA” means (a) the single application or set
of applications for a Product and/or pre-market approval to make and sell
commercially such Product filed by [***] with the EMA or other equivalent
Regulatory Authority in any country in the Licensed Territory, and (b) any
related registrations with or notifications to the EMA or other equivalent
Regulatory Authority in any country in the Licensed Territory.

1.49 “Net Sales” means the gross amount recorded from arms-length transactions
by VFMCRP, its Affiliates [***] less the following deductions, in each case to
the extent related to the Product and recognized and allowed in accordance with
IFRS:

(a) Credits or allowances on account of price adjustments, recalls, claims,
damaged goods, rejections or returns of items previously sold;

(b) Taxes, duties, tariffs and governmental charges (excluding taxes based on
net income of the Selling Party, but including claw backs) paid in connection
with the Product;

(c) Freight, insurance and transportation costs;

(d) Trade, quantity and cash discounts, charge back payments and rebates granted
to governmental entities or agencies, purchasers, payors, reimbursers,
customers, Distributors, Wholesalers, and group purchasing and managed care
organizations (and other similar entities and institutions); and

(e) Bad debt and uncollectible invoiced amounts that are actually written off
even if the inclusion of such amounts is not normally included under IFRS to
calculate Net Sales; provided that in no event would the amounts deducted
pursuant to this Section 1.49(e) exceed [***] percent ([***]%) of the gross
amount recorded.

Products transferred in connection with clinical and non-clinical research and
trials, Product promotional samples, compassionate sales or use, or indigent
programs shall not be counted toward Net Sales; [***].

If any discounts or other deductions are made in connection with sales of
Products that are bundled or sold together with other products of the Selling
Party, in no event will the discount applied to Products exceed the average
discount applied to other products of the Selling Party in such arrangement,
determined based upon the respective list prices of the Products and such other
products prior to applying the discount.

If a Product under this Agreement is sold in combination (“Combination Product”)
with another ingredient having independent, or supplementary therapeutic effect
or diagnostic utility (a “Supplemental

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Component”), then “Net Sales,” for purposes of determining royalty payments on
the Combination Product, shall be calculated using one of the following methods:

(i) By multiplying the Net Sales of the Combination Product (calculated prior to
the application of this formula) by the fraction A/(A+B), where A is the average
gross selling price, during the applicable quarter in the country concerned, of
the Product when sold separately, and B is the average gross selling price,
during the applicable quarter in the country concerned, of the Supplemental
Component(s) when sold separately;

(ii) In the event that the average gross selling price of the Product when sold
separately during the applicable calendar quarter in the country concerned can
be determined, but the average gross selling price of the Supplemental Component
when sold separately cannot during the applicable quarter in the country
concerned cannot be determined, by multiplying the Net Sales of the Combination
Product (calculated prior to the application of this formula) by the fraction
A/C, where A has the meaning set forth in subclause (i) of this Section 1.49 and
C is the average gross selling price of the Combination Product; or

(iii) In the event that no such separate sales are made of the Product or any of
the Supplemental Components in such Combination Product during the applicable
quarter in the country concerned, Net Sales, for the purposes of determining
royalty payments, shall be calculated using the above formula in (i) where A is
the reasonably estimated commercial value of the Product sold separately, during
the applicable quarter in the country concerned, and B is the reasonably
estimated commercial value of the Supplemental Components sold separately,
during the applicable quarter in the country concerned. Any such estimates shall
be determined using criteria to be mutually agreed upon by the Parties.

1.50 “New Drug Application” or “NDA” means (a) the single application or set of
applications for a Product and/or pre-market approval to make and sell
commercially such Product filed by Relypsa with the FDA, and (b) any related
registrations with or notifications to the FDA.

1.51 “[***]” means any Product that [***].

1.52 “Patent” means any: (a) U.S. patent, including utility and design patents;
(b) reissues, substitutions, confirmations, registrations, validations, or
re-examinations thereof; (c) 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; and
(d) all ex-U.S. or international equivalents of any of the foregoing in the
Licensed Territory.

1.53 “Patent Application” means any: (a) U.S. patent application, including a
provisional application, nonprovisional application, continuation application, a
continued prosecution application, a continuation-in-part application, a
divisional application, a reissue application, or a re-examination application;
or (b) all ex-U.S. or international equivalents thereof that are pending at any
time during the Term before a government patent authority in any country in the
Licensed Territory.

1.54 “Phase I Clinical Trial” means any clinical study conducted on sufficient
numbers of human subjects to establish that a pharmaceutical product is
reasonably safe for continued testing and to support its continued testing in
Phase II Clinical Trials.  “Phase I Clinical Trial” shall include without
limitation any clinical trial that would satisfy requirements of 21 C.F.R. §
312.21(a).

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1.55 “Phase II Clinical Trial” means any clinical study conducted on sufficient
numbers of human subjects that have the targeted disease of interest to
investigate the safety and efficacy of a pharmaceutical product for its intended
use and to define warnings, precautions, and adverse reactions that may be
associated with such pharmaceutical product in the dosage range to be
prescribed.  “Phase II Clinical Trial” shall include without limitation any
clinical trial that would satisfy requirements of 21 C.F.R. § 312.21(b).

1.56 “Phase III Clinical Trial” means any clinical study intended as a pivotal
study for purposes of seeking Regulatory Approval that is conducted on
sufficient numbers of human subjects to establish that a pharmaceutical product
is safe and efficacious for its intended use, to define warnings, precautions,
and adverse reactions that are associated with such pharmaceutical product in
the dosage range to be prescribed, and to support Regulatory Approval of such
pharmaceutical product or label expansion of such pharmaceutical
product.  “Phase III Clinical Trial” shall include without limitation any
clinical trial that would or does satisfy requirements of 21 C.F.R. § 312.21(c),
whether or not it is designated a Phase III Clinical Trial.

1.57 “Phase IV Clinical Trial” means clinical study of a pharmaceutical product
on human subjects commenced after receipt of Regulatory Approval of such
pharmaceutical product for the purpose of satisfying a condition imposed by a
Regulatory Authority to obtain Regulatory Approval, or to support the marketing
of such pharmaceutical product, and not for the purpose of obtaining initial
Regulatory Approval of a pharmaceutical product.

1.58 “Product” means any product containing the active ingredient patiromer
sorbitex calcium which consists of a) [***], and b) a [***].  The chemical name
for patiromer sorbitex calcium is calcium, hydrolyzed divinylbenzene-Me
2-fluoro-2-propenoate-1,7-octadiene polymer sorbitol complexes. The Product
existing as of the Effective Date is a powder for suspension in water for oral
administration, formulated with the suspending agent xanthan gum, and the term
“Product” shall also include [***].  “Product” shall also include [***] of  the
foregoing that [***].

1.59 “Product Data” means all relevant data included in the Information
Controlled by Relypsa or its Affiliates in relation to the Products for use in
the Field that: (a) is in existence at the Effective Date; (b) is generated from
activities conducted by or on behalf of one Party or both Parties under the
Development Plan or otherwise necessary for Regulatory Approval Applications or
Regulatory Approvals for Products in the Field; or (c) otherwise relates to
Product safety or CMC or regulatory activities and is necessary for Regulatory
Approval of the Product for the Field in the Licensed Territory.  For clarity,
Product Data shall not include any data Controlled by Relypsa with respect to
(a) above that is solely required for the purposes of Development, obtaining
Regulatory Approvals, or Commercialization of or for the Products outside the
Licensed Territory and is not relevant to Products for use in the Field and in
the Licensed Territory.  

1.60 “Product Trademarks” means the Trademarks that are Controlled by Relypsa
and that are set forth on Exhibit 1.60.

1.61 “Quality Agreement” means the quality control and quality assurance
agreement to be mutually agreed upon by the Parties in writing within the time
period set forth in Section 8.2.

1.62 “Regulatory Approval” means with respect to a country or region, any and
all approvals, licenses, registrations or authorizations of any Regulatory
Authority necessary to commercially distribute, sell or market a Product in such
country or region, including, where applicable: (a) pre- and post-approval
marketing authorizations (including any prerequisite Manufacturing approval or
authorization related thereto);

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(b) labeling approval; and (c) technical, medical and scientific licenses, in
each case necessary for commercial distribution, sale or marketing of such
Product in such country or region.

1.63 “Regulatory Approval Application” means any and all regulatory
applications, filings, approvals, and associated correspondence required to
Develop, Manufacture, market, sell, and import Products in, or into, a given
country or region, including an MAA or an NDA.

1.64 “Regulatory Authority” means any applicable supra-national, federal,
national, regional, state, provincial, or local regulatory agencies,
departments, bureaus, commissions, councils, or other government entities,
including the FDA and  the EMA regulating or otherwise exercising authority with
respect to the Development, manufacturing or Commercialization of the Product in
a given country or region.

1.65 “Relypsa Know-How” means all Information that is: (a) Controlled by Relypsa
or its Affiliates as of the Effective Date or at any time during the Term and
that is not generally known, even though parts thereof may be known; and (b)
necessary to Develop, make, use, sell, offer for sale, import and export and
otherwise Commercialize Products for use in the Field.  Relypsa Know-How
includes, without limitation, Product Data and Improvements, but does not
include Relypsa Patent Rights.

1.66 “Relypsa Patent Rights” means all Patents and Patent Applications that are
Controlled by Relypsa or its Affiliates as of the Effective Date or at any time
during the Term and that claim inventions necessary to Develop, make, use, sell,
offer for sale, import and export and otherwise Commercialize Products for use
in the Field, including, without limitation, any Improvements.  Exhibit 11.2
sets forth a list of the Relypsa Patent Rights existing as of [***].

1.67 “Relypsa Technology” means the Relypsa Patent Rights and Relypsa Know-How.

1.68 “Royalty Term” means the period during which royalties are payable by
VFMCRP in accordance with Section 7.4.

1.69 “Sublicensee” means a Third Party (a) who is granted a sublicense permitted
under Section 2.3 under the license granted to VFMCRP pursuant to Section 2.1,
and (b) whose role with respect to Products in a country of the Licensed
Territory [***].

1.70 “Tax” or “Taxation” means any form of tax or taxation, levy, duty, charge,
social security charge, contribution or withholding of whatever nature
(including any related fine, penalty, surcharge or interest), including Indirect
Taxes.

1.71 “Tax Authority” means any government, state or municipality, or any local,
state, federal or other fiscal, revenue, customs, or excise authority, body or
official anywhere in the world, authorized to levy Tax.

1.72 “Third Party” means any person or entity other than: (a) VFMCRP; (b)
Relypsa; (c) [***];  (d) an Affiliate of VFMCRP or Relypsa; or (e) [***].

1.73 “Third Party Agreement” means any agreement entered into after the
Effective Date with a Third Party by VFMCRP or its Affiliates, or any amendment
thereto, whereby royalties, fees or other payments are to be made to the Third
Party based on the exploitation of or right to use Patents, Information or

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intellectual property rights Controlled by the Third Party where such Patents,
Information or intellectual property rights are used in the course of the
Development or Commercialization of the Product.  

1.74 “Third Party Payment” means all upfront payments, milestone payments,
license fees, royalties or other payments, paid or payable to any Third Party
under any Third Party Agreement.

1.75 “Trademark” means any word, name, symbol, color, designation or device or
any combination thereof, whether registered or unregistered, including, any
trademark, trade dress, service mark, service name, brand mark, trade name,
brand name, logo or business symbol.

1.76 “[***] Technology” means all Information, Patents and Patent Applications,
only to the extent jointly developed by the Parties under the Development Plan,
and only if specifically applicable to and developed for the Product relating to
[***] in the Field, including without limitation [***] in the Field.  

1.77 “[***] Technology Inventions” means all Inventions that are directed to
[***] Technology, and all intellectual property rights therein.

1.78 “United States” or “U.S.” means the United States of America and its
possessions, protectorates, and territories.

1.79 “Valid Claim” means (i) any claim of an issued and unexpired Relypsa
Patent, which has not been held unpatentable, invalid or unenforceable by a
decision of a court or other governmental agency of competent jurisdiction,
unappealable or unappealed within the time allowed for appeal, and which has not
been cancelled, withdrawn, abandoned or admitted to be invalid or unenforceable
through  reissue, disclaimer or otherwise, or (ii) or [***] included within the
Relypsa Patent Rights that has been filed [***] and is being prosecuted in good
faith, which has not lapsed, been abandoned, been held revoked, or been deemed
unenforceable or invalid by a non-appealable decision or an appealable decision
from which no appeal was taken within the time allowed for such appeal of a
court or other governmental agency of competent jurisdiction.

1.80 “VFMCRP Know-How” means all Information that is: (a) Controlled by VFMCRP
as of the Effective Date or at any time during the Term and that is not
generally known, even though parts thereof may be generally known; and (b)
necessary to Develop, make, use, sell, offer for sale, import and export and
otherwise Commercialize Products for use in the Field, including, without
limitation, [***], applicable to Products.  VFMCRP Know-How does not include
VFMCRP Patent Rights.

1.81 “VFMCRP Patent Rights” means all Patents and Patent Applications that are
Controlled by VFMCRP as of the Effective Date or at any time during the Term and
that claim inventions necessary to Develop, make, use, sell, offer for sale,
import and export and otherwise Commercialize Products for use in the Field,
including, without limitation, [***] applicable to Products.

1.82 “VFMCRP Technology” means the VFMCRP Patent Rights and the VFMCRP Know-How.

1.83 “VFMCRP Trademarks” means the trademarks set forth on Exhibit 1.83.

1.84 “Wholesaler” means any Third Party whose role with respect to Product in
the Licensed Territory is only to (a) [***], or (b) resell products to
end-customers.

1.85 “Year” means any given twelve (12) month period commencing on a specified
date.

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2. License Grants and Other Rights and Discussions

2.1 License Grant to VFMCRP.  Subject to the terms and on the conditions of this
Agreement, Relypsa hereby grants to VFMCRP:

(a) an exclusive (even as to Relypsa), royalty-bearing license, with the right
to grant sublicenses as provided in Section 2.3, under the Relypsa Technology,
to Develop (subject to Sections 4.4 and 4.6), make and have made (subject to
Article 8), use, sell, offer for sale, promote, import and export and otherwise
Commercialize Products in the Field and in the Licensed Territory.

(b) a non-exclusive, royalty-free license (except for any portion of any Third
Party Payments to be paid by VFMCRP under this Agreement), with the right to
grant sublicenses through multiple tiers of sublicensees, under the Relypsa
Technology: (i) to conduct VFMCRP’s responsibilities outside the Licensed
Territory and in the Field pursuant to the Development Plan, if applicable; and
(ii) to conduct manufacturing activities (subject to Article 8) for Products
outside the Licensed Territory to support Development (subject to Sections 4.4
and 4.6)and Commercialization of Products in the Field and in the Licensed
Territory.

(c) a co-exclusive license, with the right to grant sublicenses as provided in
Section 2.3, under Relypsa’s rights in the Product Trademarks, to use the
Product Trademarks solely in the Licensed Territory and solely to fulfill its
obligations under Section 6.4, and otherwise in accordance with Section 6.5, and
a non-exclusive license, with the right to grant sublicenses as provided in
Section 2.3, under Relypsa’s rights in the Relypsa Trademark solely to the
extent provided in Section 6.5.  This license shall be royalty-free during the
Term and shall be royalty-bearing after the Term.

2.2 License Grant to Relypsa.  Subject to the terms and on the conditions of
this Agreement, VFMCRP hereby grants to Relypsa:

(a) a non-exclusive, royalty-free license (except for any portion of any Third
Party Payments to be paid by Relypsa under this Agreement), with the right to
grant sublicenses through multiple tiers of sublicensees, under the VFMCRP
Technology: (i) to conduct Relypsa’s responsibilities in the Licensed Territory
and in the Field pursuant to the Development Plan and otherwise to support the
Development of the Products in the Licensed Territory and in the Field as
directed by the JDC; and (ii) to conduct Development (subject to Section 4.6)
and manufacturing activities for Products in the Licensed Territory to support
Development and Commercialization of Products in the Field outside the Licensed
Territory.  

(b) a non-exclusive, royalty-free license (except for any portion of any Third
Party Payments to be paid by Relypsa under this Agreement), with the right to
grant sublicenses through multiple tiers of sublicensees, under the VFMCRP
Technology, to Develop, make and have made, use, sell, offer for sale, promote,
import, export and otherwise Commercialize Products in all fields of use.  This
license shall be limited to those countries outside the Licensed Territory;
however, after expiration or termination of this Agreement by Relypsa, this
license shall automatically become worldwide, except as otherwise expressly
provided in Article 15.

2.3 Sublicense Rights.  VFMCRP shall have the right to grant sublicenses through
multiple tiers under the licenses granted to it under Section 2.1, without
Relypsa’s prior written consent, only to: (a) [***]; (b) [***]; (c) [***] (d)
[***].  For the avoidance of doubt, if VFMCRP wishes to grant a sub-license to a
[***], it is required to obtain Relypsa’s prior written approval, which shall
not be unreasonably withheld, delayed or conditioned.

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2.4 Exclusivity.

(a) Subject to Section 2.4(b), neither Party shall, during the Term, and after
the Term (as described in Sections 15.2 – 15.6), except as expressly permitted
by this Agreement, directly or indirectly (including through its Affiliates,
licensees, permitted sublicensees under Section 2.3 or associates), Develop,
manufacture, market, distribute, sell or otherwise Commercialize: (i) any
Product; or (ii) [***], in the Field in the Licensed Territory.

(b) The foregoing exclusivity restriction in Section 2.4(a) shall [***] (i)
[***] with respect to [***], (ii) [***], or (iii) [***].

2.5 Limitation.  Each Party covenants and agrees that such Party shall not (and
shall ensure that its Affiliates and its permitted sublicensees shall not) use
or practice under any intellectual property right licensed to such Party under
this Agreement except as expressly permitted by this Agreement.  

2.6 Retained Rights.  Relypsa retains all rights to use the Relypsa Technology,
except to the extent expressly licensed to VFMCRP under the terms of this
Agreement.  VFMCRP retains all rights to use the VFMCRP Technology, except to
the extent expressly licensed to Relypsa under the terms of this Agreement.  In
no event shall VFMCRP be obligated to transfer to Relypsa, by license or
otherwise, any Existing [***] Technology pursuant to this Agreement without
VFMCRP’s prior written consent.  

2.7 No Implied Rights or Licenses.  Except as expressly provided in this
Agreement, nothing shall grant either Party any right, title or interest in and
to any Patent Application, Patent, Information, Trademark or other intellectual
property right of the other Party, whether expressly, by implication or by
estoppel.

2.8 [***].  [***].

2.9 [***]. VFMCRP, on its own behalf and on behalf of its Affiliates, hereby
[***] that none of VFMCRP or its Affiliates or Sublicensees shall [***], in
respect of [***].  This [***] shall not [***], except as expressly permitted
[***] this Agreement, [***].

3.Governance

3.1 General.

(a) JSC and JDC.  Promptly after the Effective Date, the Parties shall
establish: (i) a joint Steering Committee (the “Joint Steering Committee” or
“JSC”) in accordance with Section 3.2 to coordinate and oversee the Parties’
activities under this Agreement and the Manufacturing and Supply Agreement; and
(ii) a specialized joint committee (such committee, the “Joint Development
Committee” or “JDC”) in accordance with Section 3.3 focusing on Development and
Regulatory Approval of Products.  The JSC and JDC shall have the
responsibilities and authority allocated to it in this Article 3 and elsewhere
in this Agreement.  The JSC and JDC may be referred to separately as a
“Committee” and jointly as the “Committees”.

(b) Limitations on the Authority of Committees.  Notwithstanding the Committee
structure established pursuant to Section 3.1(a), 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 a

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Committee unless such delegation or vesting of rights is expressly provided for
in this Agreement or the Parties expressly so agree in writing.  Without
limiting the generality of the foregoing, no Committee shall have any authority
or jurisdiction to amend, modify, or waive compliance with this Agreement, any
of which shall require mutual written agreement of the Parties.

(c) Membership.  Each of VFMCRP and Relypsa shall designate representatives with
appropriate expertise to serve as members of each Committee, as set forth in
Section 3.2(a) and Section 3.3(a).  Each Party may replace its Committee
representatives at any time upon written notice to the other Party.  Each
Committee shall have a chairperson that alternates between the Committee
representatives of each Party annually.  The initial chairperson of the JSC and
JDC shall be appointed by Relypsa.  Each Party may change its designated
chairperson from time to time upon written notice to the other Party.  The
chairperson shall be responsible for calling meetings, preparing and circulating
an agenda in advance of each meeting of such Committee, and preparing and
issuing minutes of each meeting within [***] ([***]) days thereafter.  The
minutes of each meeting shall, among other things, record all matters acted upon
and approved or disapproved by the Committee, actions to be taken, and any
matters the Committee failed to resolve.  Such minutes will not be finalized
until both Alliance Managers review and confirm in writing the accuracy of such
minutes.  

(d) Meetings.  Unless otherwise agreed by the Parties, each Committee shall hold
meetings at such times as it elects to do so, but in no event shall such
meetings be held less frequently than once every [***] for the JDC, and once
every [***] for the JSC.  Each Committee shall meet alternately at Relypsa’s
facilities in Redwood City, California, and VFMCRP’s facilities in Glattbrugg,
Switzerland, or at such other locations as the Parties may agree.  The Alliance
Managers shall, and up to [***] (or more if agree by the parties) other
employees of each Party involved in the Development, Manufacture, or
Commercialization of any Product may attend meetings of each Committee (as
nonvoting participants unless they are members of such Committee), and
consultants, representatives or advisors involved in the Development,
Manufacture or Commercialization of any Product may attend meetings of each
Committee as nonvoting observers; provided that such employees and Third Party
representatives are under obligations of confidentiality and non-use applicable
to the Confidential Information of each Party that are at least as stringent as
those set forth in Article 14, and in the case of non-employees of a Party,
subject to the consent of the other Party, which shall not be unreasonably
withheld, delayed or conditioned.  Each Party shall be responsible for all of
its own expenses of participating in any Committee.  Meetings of any Committee
may be held by audio or video teleconference; provided that at least [***]
meeting per [***] of such Committee shall be held in person.  No action taken at
any meeting of a Committee shall be effective unless a representative of each
Party is participating.

(e) Committee Decisions.  Each Party’s designees on a Committee shall, [***] on
all matters brought before the Committee, which [***].  Except as expressly
provided in this Section 3.1(e), each Committee shall operate as to matters
within its jurisdiction by [***].  All decisions of a Committee shall be
documented in writing in the minutes of the applicable Committee meeting by the
Alliance Managers.  Any disagreement between the representatives of the Parties
on the JDC as to matters within the JDC’s jurisdiction shall be submitted for
discussion and resolution [***].  Any disagreement between the representatives
of the Parties on the JSC as to matters within the JSC’s jurisdiction shall be
submitted for discussion and resolution by [***] in accordance with Section
17.9, following which time, if the Parties have failed to resolve the dispute as
provided in Section 17.9, then (i) [***] shall have the right to make the final
decision on matters within the jurisdiction of the Committee that [***] and
[***], and (ii) [***] shall have the right to make the final decision on matters
within the jurisdiction of the Committee that [***] and [***], except that, in
any case, any decision to [***] must be made [***] (for clarity, if [***] on
such matter, the [***] and neither Party may pursue any resolution pursuant to
Sections 17.9 and 7.10).

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(f) Each Party will disclose to the other proposed agenda items along with
appropriate information at least [***] in advance of each meeting of each
Committee, as applicable; provided that, under exigent circumstances requiring
the Committee’s input, a Party may provide its agenda items to the other Party
within a lesser period of time in advance of the meeting, or may propose that
there not be a specific agenda for a particular meeting, and such items shall be
included in such agenda if such other Party consents to such later addition of
such agenda items or the absence of a specific agenda for such Committee
meeting.

3.2 Joint Steering Committee.

(a) Formation and Purpose.  Each Party shall appoint [***] ([***]) of its [***]
to serve on the JSC.  The initial JSC representatives for VFMCRP shall be [***],
and the initial JSC representatives for Relypsa shall be [***].  The JSC shall:
(i) [***] the [***], and the [***] in the Licensed Territory in the Field to
[***] in the Licensed Territory in the Field; (ii) [***] for the Licensed
Territory in the Field; and (iii) [***] activities to be conducted in connection
with Commercialization of the Products in the Field in the Licensed Territory,
[***].  

(b) Specific Responsibilities of the JSC.  In connection with its
responsibilities described in Section 3.2(a), the JSC shall in particular:

(i) provide general oversight for the activities of the JDC;

(ii) provide a forum for the Parties to share information, knowledge and
planning on the on-going Development and Commercialization of the Products in
and outside the Licensed Territory.  

(iii) [***] updates or amendments, including without limitation those resulting
from discussions conducted pursuant to Section [***];

(iv) [***] of and process for [***] with respect to the Products in the Licensed
Territory in the Field based on the [***] updates provided by the JDC according
to Section 3.3(b);

(v) support [***] of a strategy for Commercialization of the Products for use in
the Field in the Licensed Territory, [***] for such [***] activities, and
exchange information on best practices for Commercialization activities for use
in the Field;

(vi) align on a global [***] and [***](for example, [***]) and coordinate
activities with respect to certain [***];

(vii) monitor and discuss [***] for the Licensed Territory [***];

(viii) discuss and approve a [***];

(ix) perform such other activities as are expressly allocated to the JSC in this
Agreement; and

(x) determine [***]; provided that [***].

(c) Exclusions from Responsibilities of the JSC.  Notwithstanding the foregoing:
(i) activities pertaining to: (A) [***]; and (B) Commercialization of the
Product (with the exception of activities with respect to Commercialization set
forth in Section 3.2(b)(vi)), will be the sole responsibility of VFMCRP in

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the Licensed Territory and of Relypsa outside the Licensed Territory; and (ii)
activities pertaining to [***] shall be the sole responsibility of [***] within
and outside the Licensed Territory, subject to [***] and except as set forth in
Section 3.2(b)(vi).  The activities listed in (i) and (ii) above shall not come
under the governance authority of the JSC, but information with respect thereto
may be discussed by the JSC to the extent relevant to the items set forth in
Sections 3.2(a) and 3.2(b).

3.3 Joint Development Committee.

(a) Formation and Purpose.  Each Party shall appoint [***] ([***]) of its [***]
to serve on the JDC.  The initial JDC representatives for VFMCRP shall be [***],
and the initial JDC representatives for Relypsa shall be [***].  The JDC shall
coordinate communication and operations regarding the [***] of, and the [***]
for, the Products in the Licensed Territory in the Field in order to [***] of
Products in the Licensed Territory in the Field.  The JDC will also facilitate
the flow of information with respect to [***] activities being conducted for the
Product that in or outside the Field that are relevant to the Licensed Territory
(whether or not conducted in or outside the Licensed Territory, subject to
Section [***]), and to facilitate exchange of [***] of Products relevant to the
Licensed Territory, whether conducted in or outside the Licensed Territory and
in the Field, subject to Section 4.4.

(b) Specific Responsibilities of the JDC.  In connection with its
responsibilities described in Section 3.3(a), the JDC shall in particular:

(i) provide a forum for the Parties to share information, knowledge and planning
on the [***] activities for the Products relevant to the Field in [***] the
Licensed Territory;

(ii) review and discuss the [***] updates or amendments;

(iii) review and exchange [***] information and reports for Products in and
outside the Field and in accordance with the [***] agreement;

(iv) monitor [***] activities for Products in the Field in the Licensed
Territory, including with respect to [***] matters such as [***] strategies;

(v) review and facilitate the exchange of all Information (other than any
Information relating to the [***] or [***] of Product) relating to or arising
from all [***] activities described in subsections (i) - (iv) above for Products
in the Field in [***] the Licensed Territory, subject to Section [***];

(vi) discuss and review a [***] strategy and plan for obtaining [***] for the
Products in the Field in the Licensed Territory;

(vii) with input from [***] with respect to its strategy for [***], develop and
implement a strategy for [***] with respect to Products in the Field in the
Licensed Territory, subject to Section [***];

(viii) discuss and coordinate post-approval changes to [***], including any
changes to the [***] for Products in the Field in [***] the Licensed Territory;

(ix) provide on a [***] basis updates on its activities and achievements to the
JSC for review and comment;

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(x) establish policies for [***] to use in determining whether and how to
support [***] of the Product in the Field and in the Licensed Territory, and the
[***];

(xi) perform such other activities as are expressly allocated to the JSC in this
Agreement; and

(xii) review and approve any Third Party to be retained by either Party perform
[***] activities (e.g., [***] activities) with respect to Products in the
Licensed Territory.

3.4 Subcommittees.  The JSC shall have the right to establish from time to time
one or more subcommittees or working groups to address specific matters relating
to Products in the Field in the Licensed Territory.  

3.5 Relypsa’s Membership in the Committees.   Relypsa's membership in the JSC
and the JDC (the “Committees”) shall be at its sole discretion, as a matter of
right and not obligation, for the sole purpose of participation in governance,
decision-making, and information exchange with respect to activities within the
jurisdiction of the Committees.  Relypsa shall have the right to withdraw, at
any time after the [***] ([***]) anniversary of the Effective Date, from
membership one or both of the Committees upon [***] ([***]) days' prior written
notice to VFMCRP, which notice shall be effective upon the expiration of such
[***] ([***]) day period.  Following the issuance of such notice: (a) Relypsa's
membership in the applicable Committee(s) shall be terminated and (b) each Party
shall have the right to continue to receive the information it would otherwise
be entitled to receive under the Agreement and to participate directly with the
other Party in discussions, reviews and approvals currently allocated to the
relevant Committee(s) pursuant to Article 3.  If, at any time, following
issuance of such a notice, Relypsa wishes to resume participation in the
relevant Committee, Relypsa shall notify VFMCRP in writing and, thereafter,
Relypsa's representatives to the relevant Committee shall be entitled to attend
any subsequent meeting of such Committee and to participate in the activities
of, and decision-making by, such Committee as provided in this Article 3 as if
such notice had not been issued by Relypsa pursuant to this Section 3.5.  If a
Committee is disbanded, then any data and information of the nature intended to
be shared within such Committee shall be provided by each Party directly to the
other Party and decisions formerly within the jurisdiction of such Committee
shall be made by the Parties as if they were themselves members of such
Committee as set forth in Section 3.1(e).

3.6 Alliance Managers.

(a) Each of the Parties shall appoint a single individual to act as that Party’s
point of contact for day to day communications between the Parties relating to
the activities conducted under this Agreement (each, an “Alliance
Manager”).  Each Party may change its designated Alliance Manager from time to
time upon written notice to the other Party.  Any Alliance Manager may designate
a substitute to temporarily perform the functions of that Alliance Manager by
written notice to the other Party.

(b) Each Alliance Manager shall be charged with creating and maintaining a
collaborative work environment within the JSC and JDC.  Each Alliance Manager
will also: (i) be the point of first referral in all matters of conflict
resolution; (ii) coordinate the relevant functional representatives of the
Parties in developing and executing strategies and the Development Plan for the
Products in the Field in and outside the Licensed Territory and any other
Development activities with respect to the Field by the Parties; (iii) provide a
single point of communication for seeking consensus both internally within the
respective Parties’ organizations and between the Parties regarding key strategy
and Development Plan issues; (iv) identify and bring disputes to the attention
of the JSC and JDC in a timely manner; (v) plan and coordinate cooperative
efforts and internal

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and external communications; and (vi) coordinate governance activities, such as
the conduct of JSC and JDC meetings and production of meeting minutes so that
they occur as set forth in this Agreement, and take actions necessary to
facilitate performance of relevant action items resulting from such meetings are
appropriately carried out or otherwise addressed.

(c) The Alliance Managers shall attend all Committee meetings and support the
chairperson of the JSC and JDC in the discharge of their responsibilities.  The
Alliance Managers shall be nonvoting participants in Committee meetings, unless
they are also appointed members of a Committee; provided, however, that an
Alliance Manager may bring any matter to the attention of any Committee if such
Alliance Manager reasonably believes that such matter warrants such attention.

4. Development

4.1 [***] Responsibilities.  The Parties intend to collaborate with respect to
Development to support Regulatory Approval of the Product in the Field in the
Licensed Territory.  [***] shall be solely responsible, [***], for conducting
the Development activities allocated to it in the Development Plan, if
any.  [***] shall, [***], use Commercially Reasonable Efforts to conduct the
Development activities allocated to [***] pursuant to the Development Plan.  For
the avoidance of doubt, [***] obligations under this Section 4.1 will not apply
to [***] other than the Products.

4.2 [***] and Joint Party Responsibilities.  [***] shall be solely responsible,
[***], for conducting the Development activities allocated to it in the
Development Plan, if any.  The Parties shall discuss Development activities
other than those included in the Development Plan that may be conducted by both
Parties together or by either Party alone in the Field as provided in Section
4.4.  [***] shall, [***] [***], use Commercially Reasonable Efforts to conduct
the Development activities allocated to VFMCRP pursuant to the Development Plan
and to [***] in at least the following countries: (a) the [***]; and (b) the
[***]. VFMCRP and Relypsa shall each update the JDC on all material developments
occurring in the course of activities under the Development Plan that are
necessary or useful for activities in the Licensed Territory, including without
limitation (a) sharing all results of the Development activities on a timely
basis, and sharing reports summarizing such results, as they become available,
(b) reporting on feedback obtained from Regulatory Authorities in the Licensed
Territory regarding Development activities and/or the Product, and (c) advising
the JDC on progress in enrolling patients in Clinical Trials.

4.3 Development Plan.  

(a) Development Plan.  The Development of Products in the Field in the Licensed
Territory shall be governed by a plan to be agreed upon by the JSC within [***]
([***]) days after the Effective Date (the “Development Plan”).  As of the
Effective Date, the Development Plan shall include (i) [***] of [***] study for
Product [***] the Licensed Territory, (ii) [***] of studies to [***], and (iii)
to the extent that such study is a [***], [***] of a study that [***] (which
[***] shall structure in consultation with [***] to meet, to the extent
reasonable, the [***]).  [***] would have rights to such data for purposes of
[***] as further described in Article 5.  [***] shall not have any obligation to
provide funding or incur costs in connection with any Clinical Trials or other
studies to be conducted pursuant to the Development Plan unless it otherwise
agrees, whether through the mechanism set forth in Section 4.4 or
otherwise.  The Development Plan shall include, without limitation, details of
all Clinical Trials to be conducted by the Parties to support Regulatory
Approval for Products in the Field within the Licensed Territory, and related
time lines, as well as other material activities necessary for Development of
Products in the Field in the Licensed Territory, all preclinical studies,
toxicology, pharmacology studies, formulation, and manufacturing process
development for the Product.  The Development

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Plan would include, without limitation, any plans by [***] to perform activities
in connection with a [***] in the Field for the Licensed Territory, which [***],
subject to its obligation to discuss such activities with the JDC.  For clarity,
[***] shall not perform or have performed any Development outside the scope of
the Development Plan.

(b) Updates.  The JDC shall, on [***], propose updates to the timing and scope
of activities under the Development Plan for the following [***] for review and
comment by the JSC.  The JDC shall provide comments on such updated Development
Plan by [***] of each [***], and the JDC shall consider and incorporate all
reasonable comments in good faith, and following any amendment, such updated
Development Plan shall apply to the following [***].  The JDC shall also update
the Development Plan and submit it for review, comment and approval by the JSC
to the extent required under Sections 3.2(b)(iii) and 4.4.

4.4 Additional Development.  

(a) If (i) [***] wishes to develop the Products in the Licensed Territory for
[***], to develop [***], or to [***], or (ii) [***] wishes to develop (w)
Product comprising [***], (x) Products for [***], (y) to develop [***], or (z)
to conduct [***] (each, an “Additional Study”), then such Party may so notify
the other Party and present the proposed design and projected costs of such
Additional Study to the JDC.  If the other Party through its members of the JDC
agrees to conduct such co-development and co-fund such Additional Study, the
Parties would amend the Development Plan to include such additional study and
the associated costs [***], in which case [***] would be [***] in connection
with exercising its rights under this Agreement with respect to the Product in
the Field and [***] and for [***] of the Licensed Territory in connection with
the Product in the Field.  

(b) If the non-proposing Party does not wish to co-fund such proposed Additional
Study, [***], the proposing Party may proceed with such Additional Study and
would be solely responsible for the conduct and costs of such study.  In such
case, the [***] would have [***], except with respect to [***] required to be
filed with the [***] as set forth below, in any [***] in its territory (for
[***], in the Licensed Territory and for [***], outside of the Licensed
Territory).  [***] right to conduct any proposed Additional Study unilaterally
would [***].  

(c) Notwithstanding the foregoing, if the non-proposing Party [***], such
non-proposing Party would have the right to refer such matter to [***] and, as
needed, [***] for resolution of whether such proposed Additional Study would
have the effect that is concerning the non-proposing Party.  If the matter is
not resolved by [***], it shall be submitted for discussion and resolution in
accordance with Section 17.9(c).  Notwithstanding anything to the contrary in
the foregoing in this Section 4.4, if [***] proposes activities under Section
4.4(a)(ii)(w), then [***] shall be able to conduct such activities, except that
if such activities [***] [***], and if such activities would [***], then [***]
shall [***].

(d) [***] right to conduct unilaterally an Additional Study as described above
would not include the right to conduct such study [***] without the consent of
[***].  [***] right to conduct unilaterally an Additional Study would not
include the right to conduct such study in patients [***] without the consent of
[***].

(e) Notwithstanding the foregoing, the non-proposing Party would have the right
to [***] to [***] any Additional Study for the Product for which the
non-proposing Party declined previously to [***] by [***] the proposing Party
[***] to conduct such Additional Study prior to the [***] to conduct such
Additional Study after such [***], to the extent applicable.

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(f) Notwithstanding the foregoing provisions of this Section 4.4, if the [***]
Regulatory Approval for the Product [***] is [***] than [***] the Regulatory
Approval for the Product [***], the Parties shall negotiate in good faith on the
conduct and [***] under this Section 4.4 of [***] for the Product [***] to
include the [***].  The Parties anticipate that any such [***] will either be
included in the Development Plan created after the Effective Date or that [***].

4.5 Subcontracting Permitted.  Subject to Section 2.3, each Party acknowledges
and agrees that portions of the work to be performed by the other Party under
the Development Plan (including manufacture of Products) may be performed on
behalf of the Party by Third Parties; provided that VFMCRP shall not use any
Third Party to perform manufacturing activities with respect to Products without
first obtaining the prior written consent of Relypsa.  To the extent a Party
engages subcontractors to perform activities on its behalf, the Party shall: (a)
first have obtained written confidentiality agreements with any such
subcontractors and written assignments of, or equivalent rights under, all
Patent rights and Information that such subcontractors may develop by reason of
work performed under this Agreement; and (b) be and remain responsible for the
performance of its subcontractors

4.6 Development Activities in Licensed Territory. Relypsa retains the right to
conduct Development of Products in the Licensed Territory solely to the extent
necessary or useful to [***] for or [***] of Product in connection with
[***].  If Relypsa plans to undertake such activities, it shall so notify the
JSC and shall reasonably consider any concerns expressed with respect to such
activities by the JSC.

4.7 Investigator-Sponsored Trials. The JDC shall establish and implement a
policy regarding publications of investigator-sponsored trials of the Product in
the Licensed Territory, which shall include the ability of the Parties to
comment thereon, including without limitation with respect to study design and
endpoints, and to request delays to allow the filing of patent applications on
any patentable inventions disclosed therein in a manner consistent with Section
14.6.  Any such policy regarding investigator-sponsored trial shall require the
[***], notwithstanding anything to the contrary in Section 3.1(e).

4.8 Clarification.  For clarity, the license granted to VFMCRP pursuant to
Section 2.1 to Develop Product shall be limited to the extent VFMCRP has such
rights under this Article 4.

5. Regulatory Matters

5.1 Preparation and Ownership of Regulatory Filings.

(a) [***], shall [***], and shall [***] for the Product in the Field to be [***]
(the “[***]”).  [***] shall provide [***] with written notice of all [***] with
respect to the [***] prior to its filing.  [***] shall have the [***], as well
as [***].  [***] shall also have [***], and to have [***].  [***], all [***]
with respect to Product [***] will be in the name of and under the direction of
[***].  [***] shall [***], and shall [***], subject to [***].  Such [***] by a
representative of [***].  The [***] will be [***] and be subject to [***].  The
[***] will be [***].  [***] will develop a schedule for [***] on the
[***].  [***] shall [***]. The [***] must be [***]. [***] will be the [***] in
the [***].  [***] shall have [***]), and shall [***], to [***] and [***].  The
[***] of the [***] will be [***], and [***] by [***].  The [***] for Product in
the Licensed Territory shall be the “[***]”.  [***] will be responsible for
[***], including the [***] and [***], and will be [***].  [***] will [***],
including the [***].  [***] will provide [***], including [***]; provided that
if such [***], the Parties will [***]; and further provided that [***] shall
have [***].

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(b) [***] will be the [***] in the [***].  [***] shall have [***], and shall
[***], to [***] in at least the [***], and in the Field.  [***] shall [***] in
the Licensed Territory; provided that if [***], [***]; and further provided that
[***] shall [***].  [***] will [***].

(c) Any [***] will be [***] unless [***] and [***] shall [***].

(d) [***] shall [***] with respect to the Product in the Field in the [***], and
[***] shall [***], provided that [***] shall [***] [***] relating to the
Products in the [***], and to [***] for such Product.  [***] shall [***].  [***]
shall [***], in connection with such regulatory activities, including [***].  

(e) As between Relypsa and VFMCRP, [***] shall [***] covering each Product [***]
for all Products at all times.  [***] shall be [***].  [***] shall [***], in
connection with such regulatory activities for Product [***], at [***].  The
[***] will [***].

5.2 Ownership of Data; Rights to Use Data.

(a) Relypsa shall own all right, title, and interest in, to, and under all
Product Data.  VFMCRP hereby agrees to assign and assigns to Relypsa all of
VFMCRP’s right, title and interest in, to and under the Product Data, and VFMCRP
shall ensure that its permitted sublicensees, Affiliates, independent
contractors, employees or agents to so assign to Relypsa such of their right,
title, and interest in, to, and under the Product Data.  VFMCRP shall keep
accurate records of all Product Data generated as a result of VFMCRP’s
activities under this Agreement, and shall provide Relypsa with copies of all
such Product Data promptly following the generation of such Product
Data.  Product Data is included in the Relypsa Know-How and licensed to VFMCRP
pursuant to Section 2.1.  

(b) Notwithstanding anything to the contrary in this Agreement, Relypsa shall
promptly provide to VFMCRP, [***], copies of and rights of reference to and use
of all Product Data that is owned or Controlled by Relypsa, and that are
relevant to or necessary to address issues relating to: (A) the safety of
Products, including data that is related to adverse effects experienced with
Products, or (B) CMC activities relating to the Products, and in each of (A) and
(B), that are required to be reported or made available to Regulatory
Authorities in the Licensed Territory, when and as such data become available
(collectively, “Safety and CMC Data”).  VFMCRP shall use the Safety and CMC Data
provided to it pursuant to this Section 5.2(b) solely to Develop and
Commercialize Products in the Field in the Licensed Territory.

(c) Each Party shall maintain, or cause to be maintained, all data, results and
analyses (including site records and master files) resulting from, and all
records of, Development and other activities under this Agreement by such Party,
its Affiliates or permitted subcontractors, in sufficient detail and in good
scientific manner appropriate for performing its obligations and exercising its
rights under this Agreement with respect to [***].  The foregoing data, results,
analyses and records: (i) shall be complete and accurate and shall fully and
properly reflect all work done and results achieved in the performance of its
respective activities hereunder; (ii) shall record only such activities and
shall not include or be commingled with records of activities outside the scope
of this Agreement; and (iii) shall be retained by the relevant Party for at
least [***] ([***]) Years after the termination of this Agreement or for such
longer period as may be required by Applicable Law.  Each Party shall have the
right, during normal business hours and upon reasonable notice, to inspect and
copy any such records of the other Party.

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5.3 Notice of Communication with Regulatory Authorities.

(a) After the MAA Date for a Product, [***] shall be responsible for handling
all complaints and communications (including with Regulatory Authorities)
relating to such Product [***].  [***] shall notify [***] of any material oral
or written communications to or from Regulatory Authorities on matters related
to the Product or which may reasonably be deemed to impact Product Development,
manufacture, marketing or Regulatory Approval [***] in the Field, and shall
provide [***] with copies of any such material written communications within
[***], or earlier as specified in the Pharmacovigilance Agreement, of receipt or
delivery of such communication, as the case may be, or such earlier date as
required by Applicable Laws, the FDA or other relevant Regulatory Authority. In
addition to the foregoing, [***] shall give [***] reasonable opportunity to
review and comment on any proposed response to any such oral or written
communications to or from Regulatory Authorities prior to submitting any
response thereto, and provide [***] with a copy of the final response as
specified herein.

(b) Subject to Section 5.1(a), [***] shall be responsible for handling all
complaints and communications (including with Regulatory Authorities) relating
to: (i) the Product [***]; and (ii) the Product [***].  [***] shall notify [***]
of any material oral or written communications to or from Regulatory Authorities
on matters related to the Product or which may reasonably be deemed to impact
Product Development, manufacture, marketing or Regulatory Approval [***], and
shall provide [***] with copies of any such material written communications
within [***], or such earlier date as required by Applicable Laws, the FDA or
other relevant Regulatory Authority.

5.4 Adverse Event Reporting and Product Complaints.  The Parties will enter into
a pharmacovigilance agreement within [***] ([***]) days after the Effective Date
that shall govern their obligations with respect to the exchange, handling and
reporting adverse events, other safety information and Product complaints during
Development and Commercialization of the Product in the Field.  Relypsa will be
responsible for such obligations outside the Licensed Territory, and VFMCRP
shall be responsible for such obligations within the Licensed Territory.

5.5 Product Recall.  The Manufacturing and Supply Agreement shall contain
standard provisions acceptable to both Parties regarding: (a) a Regulatory
Authority’s issuance or request of a recall or similar action in connection with
the Product; and (b) either Party’s determination that an event, incident or
circumstance has occurred which may result in the need for a recall or market
withdrawal.

6. Commercialization

6.1 VFMCRP’s Responsibilities.  As between the Parties, VFMCRP will be solely
responsible for the day-to-day commercial activities for Product in the Licensed
Territory in the Field at its sole expense, including all activities relating
to: (a) pricing and reimbursement; (b) marketing and promotion activities; (c)
booking sales and distributing Product and performing related activities; (d)
handling all aspects of order processing, invoicing and collection, inventory
and receivables; and (e) providing customer support.  [***] for any taxes,
including any Indirect Taxes, that arise from Commercialization of Products in
the Licensed Territory in the Field.

6.2 VFMCRP Commercial Diligence Obligations.  VFMCRP shall use Commercially
Reasonable Efforts to Commercialize the Product in the Field in at least the
following countries after receiving required Regulatory Approvals therefor: (a)
[***]; and (b) [***].

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6.3 Commercialization Plan, Forecasts and Reports.  No later than [***] ([***])
months prior to the intended First Commercial Sale of each Product in a country
that is one of the Major Countries, VFMCRP shall present to the JSC a draft plan
for Commercialization of such Product in each country in the Major Countries,
which shall include without limitation all material prelaunch activities, sales
efforts, promotional efforts and advertising for such Product in such country,
and which shall be consistent with similar plans for similar pharmaceutical
products having [***] (the “Commercialization Plan”).  The JSC shall review and
provide comments on such Commercialization Plan, and VFMCRP shall consider in
good faith all such comments.  By [***] of each Year following the First
Commercial Sale of a Product in the Major Countries, VFMCRP shall provide to the
JSC an updated Commercialization Plan for such Product, and the JSC shall review
and provide comments on such updated Commercialization Plan within [***] ([***])
days after its receipt thereof. Concurrently with each update to the
Commercialization Plan, VFMCRP shall provide to Relypsa a good faith forecast of
sales of Products in the Major Countries during the next [***] ([***])
years.  Additionally, VFMCRP shall provide to Relypsa reports, within [***]
([***]) days after the end of each calendar quarter, specifying, [***], the
sales efforts, promotional efforts and advertising efforts made for Products in
the Licensed Territory, on a quarterly basis relative to those required in the
Commercialization Plan) in each country in the Licensed Territory where the
Product is being Commercialized.  

6.4 Packaging; [***] Product Trademarks.  VFMCRP shall be responsible for all
final commercial packaging and labeling of the Product for use in the Licensed
Territory.  VFMCRP shall use the Product Trademark for Commercializing the
Product in the Field in the Licensed Territory, subject to Section 6.5, unless
VFMCRP has a [***] for Commercializing the Product in the Field in the Licensed
Territory, in which case Relypsa shall have [***].  To the extent allowed by
Applicable Laws, all Product packaging, including package inserts and any
promotional materials associated with the Product in the Licensed Territory
shall carry, in a conspicuous location, [***] or the Product Trademark, subject
to the Parties’ approval of the size, position, and location thereof on the
Product or its components, which approval shall not be unreasonably withheld,
delayed or conditioned.

6.5 Use of Product Trademarks; Relypsa Mark.  

(a) VFMCRP shall not use any Product Trademark outside the scope of this
Agreement or take any action that would materially adversely affect the value of
any Product Trademark.  VFMCRP shall use the Product Trademark only in
accordance with Relypsa’s internal Trademark guidelines attached hereto as
Exhibit 6.5.1.  Relypsa shall retain the right to monitor and enforce the use of
the Product Trademark to the extent necessary to maintain its trademark rights
and goodwill therein.  VFMCRP shall not use any Product Trademark in packaging
materials, package inserts, labels, labeling, and marketing, sales, advertising
and promotional materials in a manner that has not been approved by Relypsa
prior to such use.  If not yet obtained, Relypsa shall use Commercially
Reasonable Efforts to obtain (a) Product Trademarks in the countries listed in
attached Exhibit 6.5.2, and (b) [***].  Relypsa may request that VFMCRP
undertake such activities under the previous sentence, and if VFMCRP agrees to
assume such responsibilities, the Parties will cooperate to coordinate such
activities and [***] thereof. Upon VFMCRP’s request, Relypsa shall use
Commercially Reasonable Efforts to obtain, additional Product Trademarks or
related [***] in the Licensed Territory.

(b) To the extent allowed by Applicable Law and consistent with Relypsa’s
internal Trademark guidelines attached hereto as Exhibit 6.5.1, all Product
labeling, packaging and package inserts and any promotional materials associated
with the Products shall carry, in a conspicuous location, the Trademark of
Relypsa with a notice that such Product is sold under license from
Relypsa.  Such Trademark, where so included, shall be in addition to the Product
Trademark and Trademarks of VFMCRP.  

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6.6 Publication Strategy.  The JSC shall develop a strategy for reviewing,
coordinating and releasing publications including results of studies conducted
for the Product by or on behalf of either Party.  Each Party would submit any
proposed publications to the other Party for review and comment as provided in
Section 14.6.  

6.7 Conferences.  [***] shall have [***] Product-related information and
materials at all conferences, congresses or scientific or medical meetings held
[***] the Licensed Territory, provided that [***] shall [***] of [***] for such
presentations and coordinate with [***] with regard thereto.  [***] shall have
[***] Product-related information and materials at all conferences, congresses
or scientific or medical meetings held in the Licensed Territory, provided that
[***] shall [***] of [***] for such presentations and coordinate with [***] with
regard thereto.  If a Party wishes to [***] in any conference, congress or
scientific or medical meeting held [***], such Party’s [***] shall be subject to
[***] of the Party having the [***] to present at such event under this Section
6.7 (the “Presenting Party”).  Such consent would be limited to [***].  

7. Payment Obligations

7.1 Upfront Payment.  In partial consideration for the rights granted to VFMCRP
under this Agreement, VFMCRP shall pay to Relypsa a one-time-only,
nonrefundable, noncreditable payment of Forty Million Dollars ($40,000,000) by
wire to an account designated in writing by Relypsa within [***] ([***]) days
after the Effective Date.

7.2 Milestone Payments.  

(a) Regulatory Milestone.  In partial consideration for the rights granted to
VFMCRP under this Agreement, VFMCRP shall pay the following nonrefundable,
noncreditable regulatory milestone payments to Relypsa, within [***] ([***])
days after achievement of the relevant milestone for a Product by or on behalf
of VFMCRP or its Affiliates or their respective permitted sublicensees, as set
forth in the table below.

 

Milestone Event

Payment

[***]

 

 

 

 

(b) Sales Milestones.  In partial consideration for the rights granted to VFMCRP
under this Agreement, VFMCRP shall pay the following nonrefundable,
noncreditable sales milestone payments to Relypsa, within [***] ([***]) days
after achievement of the relevant milestone for Products by or on behalf of
VFMCRP or its Affiliates or their respective permitted sublicensees in a
Calendar Year, as set forth in the table below.

 

Milestone Event

Payment

[***]

 

 

 

 

[***].

For clarity, more than one of the foregoing sales milestones may be met, and may
become due to Relypsa, in a given Calendar Year.

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7.3 Royalties.  In addition to any amounts due to Relypsa under Sections 7.1 and
7.2, in partial consideration for the rights granted to VFMCRP under this
Agreement (including, without limitation, license rights with respect to the
Relypsa Know-How) and, subject to Sections 7.5 and 7.6, VFMCRP shall pay to
Relypsa royalties based on the aggregate Net Sales of all Products in the
Licensed Territory by or on behalf of VFMCRP or its Affiliates or their
respective permitted sublicensees in a given Calendar Year during the Royalty
Term, on an incremental basis as set forth below.  For clarity, the royalty
rates set forth in the table in this Section 7.3, below, are intended to be
applied incrementally, with the specified royalty rate applying to the portion
of Net Sales in the Licensed Territory in a given Calendar Year that fall within
the range to which such royalty rate applies.

 

Royalty Rate

Portion of Net Sales in the Licensed Territory

in a Calendar Year (millions of Dollars)

[***]

 

 

 

 

 

 

7.4 Royalty Term.  The royalties due under Section 7.3 shall be determined on a
country-by-country and Product-by-Product basis beginning from the First
Commercial Sale of such Product in such country until the later of: (a)
expiration of the last-to-expire of a Relypsa Patent Right containing a Valid
Claim that would be infringed in such country by such Product but for the
license granted under Section 2.1(a); (b) expiration of all regulatory and data
exclusivity applicable to such Product in such country; and (c) ten (10) years
after the First Commercial Sale of such Product in such country.  For purposes
hereof, Products that [***] shall be regarded as being the same Product, but
Products that [***] shall be different Products.

7.5 Competitive Products. If, in any country or region (e.g., EU) in the
Licensed Territory, (a) one or more Competitive Product(s) during [***] achieves
a market share ([***]) in the aggregate equal to or higher than [***] percent
([***]%) of the total [***] sales of all Competitive Products and Products sold
in such country or region or (b) after Regulatory Approval of a Competitive
Product in the country or region, the [***] [***], then the royalties due under
Section 7.3 with respect to the relevant Product in the country or region shall
be reduced by [***] percent ([***]%); provided, however, that in [***] be [***],
by [***] available under this Agreement.

7.6 Third Party Payments.  If after complying with Section 10.4 either Party,
its Affiliates or its permitted sublicensees are required to pay Third Party
Payments (directly to a Third Party) in consideration for a license under [***],
that in the absence of a license thereunder would be infringed by the
Commercialization of the Product in the Field in the Licensed Territory, the
portion of such amounts payable to such Third Party arising by reason of the
Development or commercialization of Products in the Field in the Territory shall
be [***].  VFMCRP shall then be entitled to credit [***] percent ([***]%) of
such portion of such Third Party Payments in the event [***], and [***] percent
([***]%) of such portion of such Third Party Payments  in the event [***],
against any royalties due hereunder with respect to the Net Sales of the Product
to which the Third Party Payment  pertains; provided that such credit shall not
operate to reduce the royalties otherwise due to Relypsa under this Agreement by
more than [***] percent ([***]%); provided, however, that in [***] be [***] by
[***] available under this Agreement.

7.7 Payments. It is understood and agreed between the Parties that any payments
made under Article 7 are [***], which shall be [***]. Payments due under Section
7.3 shall be paid no later than [***]

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([***]) days following the end of each Calendar Quarter with respect to Net
Sales in such [***] during the Royalty Term, using an estimated payment and
reconciliation mechanism set forth in this Section 7.7.  Each payment under this
Section 7.7 shall be accompanied by a written report showing with respect to
such Net Sales: (a) the Calendar Quarter for which such payment applies; (b) the
amount recorded for gross sales of Products to Distributors, Third Parties or
[***] for Product during such Calendar Quarter; (c) the total deductions from
gross sales recorded to arrive at Net Sales recorded; (d) the quantities of all
Product sold; and (e) the amount of royalties due pursuant to this Article
7.  Within [***] ([***]) days after the end of each Calendar Year during the
Royalty Term, VFMCRP shall provide a reconciliation statement of royalty
payments actually paid by VFMCRP during such Calendar Year, and the royalty
payments actually due pursuant to this Article 7, and either [***] or [***].

7.8 Currency of Payment.  All payments to be made under this Agreement shall be
made in Dollars.  Any Net Sales during the Royalty Term in a Calendar Quarter
made in foreign currencies shall be converted into Dollars using the currency
exchange rate set forth at [***] for the [***], or if such source does not then
exist, an alternative source of such information selected by mutual agreement of
the Parties.

7.9 Withholding Taxes.  The parties expect that [***], but if any [***]
withholding should be charged, the liability for such taxes should be the sole
responsibility of [***]. Notwithstanding the foregoing, if either Party (or its
assignee pursuant to Section 17.2) [***] that [***], then the [***].

7.10 Indirect Taxes.  If any Indirect Taxes are chargeable in respect of any
payments made under Article 7, such Indirect Taxes shall be (i) to the extent
recoverable by either Party pursuant to a claim for refund or credit, borne by
such Party or (ii) in all other cases, borne [***].  The Parties shall issue
invoices for all goods and services supplied under this Agreement consistent
with Indirect Tax requirements, and to the extent any invoice is not initially
issued in an appropriate form, the invoice issuing Party shall promptly inform
the other Party and shall cooperate with such other Party to provide such
information or assistance as may be necessary to enable the issuance of such
invoice consistent with Indirect Tax requirements. The Parties shall cooperate
in accordance with Applicable Law to minimize any Indirect Taxes incurred in
connection with this Agreement.  Notwithstanding the foregoing, if either Party
(or its assignee pursuant to Section 17.2) [***] that [***], then the [***].  

7.11 Interest.  If either Party fails to make any payment when due hereunder to
the other Party under this Agreement, then interest shall accrue thereon in
United States Dollars at an annual rate equal to the lesser of (i) [***], but in
no case less than [***]%, and (ii) the maximum rate permitted by Applicable Law.

8. Manufacture And Supply

8.1 General.  Subject to Section 8.2, Relypsa will supply, itself or through a
Third Party contractor, finished, packaged Product (“Finished Product”) to
support [***] in the Licensed Territory, and Commercialization of Product in the
Licensed Territory, [***] for the Licensed Territory, in which case, Relypsa
shall itself, or through a Third Party contractor, have the [***] to [***] the
[***] (“[***]”) for [***] [***] and Commercialization of Product in the Licensed
Territory in the Field.  The binding terms and conditions for the commercial
manufacture and supply of Finished Product and, if applicable, [***] shall be
set forth in a Manufacturing and Supply Agreement to be entered into as set
forth in Section 8.2 (“Manufacturing and Supply Agreement”).  

8.2 Manufacturing and Supply Agreement for Commercial Supply of Products. The
Parties shall agree in good faith to execute a mutually satisfactory
Manufacturing and Supply Agreement containing the

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terms set forth on Exhibit 8.2 for Relypsa’s [***] of Finished Product or, if
applicable, [***] (as described in Section 8.1) to VFMCRP within [***] ([***])
days after the Effective Date.  The Manufacturing and Supply Agreement shall
provide that the Parties will discuss and cooperate to [***] of Finished Product
for [***] for the Licensed Territory within [***] following the effective date
of the Manufacturing and Supply Agreement (which may include [***]). The Parties
shall also enter into a Quality Agreement within [***] ([***]) days after the
Effective Date.  The Manufacturing and Supply Agreement shall contain terms and
conditions set forth in Exhibit 8.2 and other terms and conditions typically
contained in agreements governing the commercial manufacture of similar products
for similar purposes at similar volumes.

8.3 Clarification.  For clarity, the license granted to VFMCRP pursuant to
Section 2.1 to make Product shall be limited to the extent VFMCRP has such
rights under this Article 8 and Exhibit 8.2, and the Manufacturing and Supply
Agreement.

9. Record Keeping, Record Retention, and Audits

9.1 Record Keeping.  Each Party shall record, to the extent practical, all
Development Information relating to Products in standard laboratory notebooks,
which shall be signed, dated, and witnessed, or if kept electronically, suitably
validated.  To the extent practical, the notebooks of each Party for Products
shall be kept separately from notebooks documenting other development activities
of such Party.  Each Party shall require its employees, consultants, and
contractors (and in the case of VFMCRP and its Affiliates) to disclose any
inventions relating to the Project in writing promptly after conception.

9.2 Record Retention.  [***] shall keep complete and accurate records of its
Regulatory Approval Applications and Regulatory Approvals related to Products to
enable [***] to confirm [***] performance of its obligations under this
Agreement.  [***] shall also keep complete and accurate records in sufficient
detail to permit [***] to confirm [***] performance of its obligations under and
the accuracy of calculations of all payments made under Article 7.  The records
to be maintained by each Party under this Section 9.2 shall be maintained for a
minimum of [***] ([***]) years following the year in which the corresponding
efforts or payments, as the case may be, were made under this Agreement or
longer if by regulatory requirement.

9.3 Audit Request.  Each of the Parties shall, at its expense (except as
provided below), have the right to audit, not more than once during each [***]
and during regular business hours, the records maintained by the other Party
under Section 9.2, to determine with respect to any [***], the accuracy of any
report or payment made under this Agreement in the [***] ([***]) preceding
Years.  If a Party desires to audit such records, it shall engage an
independent, certified public accountant reasonably acceptable to the other
Party to examine such records under obligations of confidentiality no less
protective as those set forth in Article 14.  Such accountant shall be
instructed to provide to the auditing Party a report verifying any report made
or payment submitted by the audited Party during such period, but shall not
disclose to the auditing Party any Confidential Information of the audited Party
not necessary therefor.  The expense of such audit shall be borne by the
auditing Party; provided, however, that, if an error, resulting in underpayment
by the audited Party or overpayment by the auditing Party, of more than [***]
percent ([***]%) is discovered, then such expenses shall be paid by the audited
Party.  If an accountant concludes that additional payment amounts were owed to
a Party during any period, the debtor Party shall pay such payment amount
(including interest thereon from the date such amounts were payable) within
[***] ([***]) days of the date the debtor Party is first notified of such
accountant’s written report so concluding, unless the debtor Party notifies the
creditor Party of any dispute regarding the audit and commences proceedings
under Section 17.10 within such [***] ([***]) day period (in which case the
payment shall be delayed until the conclusion of any such proceeding).  Neither
Party may

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engage an auditor in any audits under this Section 9.3 on a contingent payment
basis.  Any Information received by an auditing Party pursuant to this Section
9.3 shall be deemed to be Confidential Information of the audited Party.

9.4 Survival.  This Article 9 shall survive any termination or expiration of
this Agreement for a period of [***] ([***]) Years following the final payment
made under this Agreement.

10. Inventions, Know-How, and Patents

10.1 Ownership of Inventions.

(a) General.  VFMCRP shall promptly disclose to Relypsa and Relypsa shall
promptly disclose to VFMCRP Inventions relating to the Product, including
without limitation Product Inventions or [***] Technology.   Except as set forth
in Section 10.1(b): (i) each Party shall solely own any Inventions and
intellectual property rights therein that are made, conceived, reduced to
practice, authored, or otherwise discovered solely by such Party or any of its
employees, Affiliates, licensees, sublicensees (where permitted), independent
contractors, consultants or agents, including without limitation any Patent or
Patent Application in which all of the claims included in such Patent or Patent
Application claim only such solely owned Invention; and (ii) the Parties shall
jointly own any Inventions and intellectual property rights therein that are
made, conceived, reduced to practice, authored, or otherwise discovered jointly
by the Parties or any of their employees, Affiliates, licensees, sublicensees
(where permitted), independent contractors, consultants or agents, including
without limitation any Patent or Patent Application on such jointly owned
Invention.  Each Party shall have the right to use and license jointly owned
Inventions and all intellectual property rights therein for any and all purposes
without the need to account to or seek permission from the other Party (subject,
in all cases, to any other applicable terms of this Agreement); provided,
however, that for clarity, the foregoing shall not be construed as granting or
conveying to either Party any license or other rights to the other Party’s other
intellectual property rights, unless otherwise expressly set forth in this
Agreement.  To the extent necessary to effect the foregoing, each Party grants
to the other Party a royalty-free (except or as expressly provided in this
Agreement), nonexclusive, sublicensable (through multiple tiers) license under
jointly owned Inventions and intellectual property rights therein, for all
purposes.

(b) Product Inventions.  Notwithstanding Section 10.1(a), Relypsa shall solely
own all right, title, and interest in, to, and under all Inventions (including
any Improvements) relating to, or covering: (i) [***]; (ii) [***], including
[***]; (iii) [***], including [***]; and (iv) [***], in each case whether made
by employees, sublicensees (if permitted), Affiliates, independent contractors,
consultants or agents of one Party or jointly by employees, sublicensees (if
permitted), Affiliates, independent contractors, consultants or agents of each
Party (collectively, “Product Inventions”).  Such Product Inventions, and all
intellectual property rights therein, shall be included in the Relypsa
Technology and licensed to VFMCRP pursuant to Section 2.1.  

(c) Ownership Disputes.  The JSC shall attempt in good faith to resolve any
disputes arising hereunder regarding ownership of Inventions.  In the event the
JSC is unable to resolve such dispute within [***] ([***]) days after its
receipt of notice of the dispute, the dispute resolution procedure set forth in
Article 17 shall apply.  

(d) Assignment and Perfection of Interests.  Without additional consideration,
each Party hereby assigns to the other Party such of its right, title and
interest in and to any Inventions, Improvements, Patent Rights claiming them,
and all other intellectual property rights therein, and shall ensure that its
sublicensees (if permitted), Affiliates, independent contractors, employees,
consultants or agents to so

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assign to the other Party such of their right, title, and interest in, to, and
under the foregoing, in each case only to the extent necessary to effectuate the
allocation of right, title and interest in and to Inventions as set forth in
Section 10.1(a) and 10.1(b).  Each Party shall, and shall cause its sublicensees
(if permitted), Affiliates, independent contractors, employees, consultants, and
agents to, cooperate with the other Party and take all reasonable additional
actions and execute such agreements, instruments, and documents as may be
reasonably required to perfect the other Party’s right, title, and interest in,
to, and under Inventions, Patent Rights and other intellectual property rights
as such other Party has pursuant to Sections 10.1(a) and 10.1(b).  Each Party
shall also include without limitation provisions in its relevant agreements with
Third Parties that effect the intent of this Section 10.1.  As between the
Parties, each Party that is obligated to assign its rights to the other Party
pursuant to Sections 10.1(a) or 10.1(b) shall be responsible for compensating
its employees where Applicable Law requires the assigning Party’s employee
inventors to be compensated.

(e) Each Party acknowledges and agrees that this Agreement is a “joint research
agreement” as contemplated by 35 U.S.C. § 102(c), and that all Inventions are
intended to have the benefit of the rights and protections conferred by the
Cooperative Research and Enhancement Act of 2004 (the “CREATE Act”).  In the
event that a Party seeks to rely on the foregoing and to invoke the CREATE Act
with respect to any Invention, such Party will give prior written notice to the
other Party of its intent to invoke the CREATE Act and of each submission or
disclosure such Party intends to make to the United States Patent and Trademark
Office (the “USPTO”) pursuant to the CREATE Act, including: (i) any disclosure
of the existence or contents of this Agreement to the USPTO, (ii) the disclosure
of any “subject matter developed by the other Party” (as such term is used in
the CREATE Act) in an information disclosure statement or otherwise, or (iii)
the filing of any terminal disclaimer over the intellectual property of the
other Party, it being agreed that no such submission, disclosure or filing shall
be made by such Party without the prior written consent of the other Party, such
consent not to be unreasonably withheld, conditioned or delayed, except that no
such consent shall be required to disclose to the USPTO, through an information
disclosure statement or otherwise, any “subject matter developed by the other
Party” that was previously published or included in a Patent Application by the
other Party.  The other Party will provide reasonable cooperation to such Party
in connection with such Party’s efforts to invoke and rely on the CREATE Act.

10.2 Patent Filing, Prosecution, Maintenance and Defense.

(a) Filing and Prosecution of Relypsa Patents.  Relypsa shall be responsible
([***]) for preparing, filing and prosecuting the Relypsa Patent Rights,
including all Patents and Patent Applications claiming Inventions it solely owns
under the Agreement but excluding Joint Patents (which are addressed in Section
10.2(e)).  Relypsa shall use at least reasonable efforts to prepare, file and
prosecute Relypsa Patent Rights [***] in which it is [***].  Relypsa shall use
reasonable discretion in conducting such preparation, filing and prosecution in
the Licensed Territory and shall Prosecute to Completion the same.  “Prosecute
to Completion” under this Section 10.2 shall mean [***].  Relypsa shall provide
to VFMCRP copies of [***] correspondence with patent authorities relating to
Patents issuing on Patent Applications included in the Relypsa Patent Rights for
which Relypsa is responsible under this Section 10.2(a), including notices of
allowance with respect thereto, promptly upon the filing or receipt of such
correspondence.  Subject to an appropriate agreement to protect attorney-client
privilege, Relypsa shall [***] update VFMCRP on the status of the Relypsa Patent
Rights, including information relating to major legal or patentability issues
which might impact the validity of a patent or patent application covering the
Product in the Licensed Territory.  

(b) Maintenance and Defense of Relypsa Patents.  Relypsa shall be responsible
([***]) for defending (through any derivations, interferences, reissue
proceedings, cancellations, oppositions, post grant

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reviews, Patent Challenges and reexaminations) and maintaining the Relypsa
Patent Rights, including all Patents and Patent Applications claiming Inventions
it solely owns under the Agreement but excluding Joint Patents (which are
addressed in Section 10.2(e)).  At minimum, Relypsa shall maintain and defend
Relypsa Patent Rights [***] filing or prosecuting Relypsa Patent Rights.  If any
of the Relypsa Patent Rights or Patents and Patent Applications claiming
Inventions or Improvements solely owned by Relypsa under this Agreement  becomes
the subject of any proceeding commenced by a Third Party in the Licensed
Territory (the Patents or Patent Applications under challenge the “Relypsa
Challenged Patents”) in connection with an opposition, reexamination request,
action for declaratory judgment, nullity action, interference or other attack
upon the validity, title or enforceability thereof (such an action a “Patent
Challenge”), then Relypsa shall have the right to control such defense
[***].  [***] such proceeding (but not to [***] of such defense), [***] in any
such action with respect to the Relypsa Challenged Patents that are included in
the Relypsa Patent Rights. Relypsa shall [***], and shall [***] for such Patents
and Patent Applications in the Licensed Territory.  Relypsa shall provide to
VFMCRP [***] relating to such maintenance or defense activities [***].  Relypsa
shall not [***] during maintenance and defense of such Patents or Patent
Applications that would [***] the Patents or Patent Applications (including
[***]) in the Licensed Territory, without [***].  If Relypsa decides [***] of
any Relypsa Patent Rights in the Licensed Territory, Relypsa shall provide
VFMCRP with [***] at least [***] ([***]) days prior to any [***] thereof.  In
such event, if [***] of any such Relypsa Patent Rights in the Licensed
Territory, Relypsa [***] but VFMCRP shall [***] for such [***], provided that
[***] (for clarity, if [***]).  

(c) Filing and Prosecution of VFMCRP Patents.  VFMCRP shall be responsible
([***]) for preparing, filing and prosecuting the VFMCRP Patent Rights,
including all Patents and Patent Applications claiming Inventions it solely owns
under the Agreement but excluding Joint Patents (which are addressed in Section
10.2(e)).  VFMCRP shall use reasonable efforts to prepare, file and prosecute
VFMCRP Patent Rights [***] filing or prosecuting VFMCRP Patent Rights.  VFMCRP
shall use reasonable discretion in conducting such preparation, filing and
prosecution in the Licensed Territory and shall Prosecute to Completion the
same.  VFMCRP shall provide to Relypsa copies of any material correspondence
with patent authorities relating to Patents issuing on Patent Applications
included in the VFMCRP Patent Rights for which VFMCRP is responsible under this
Section 10.2(c), including [***], promptly upon the filing or receipt of such
correspondence.

(d) Maintenance and Defense of VFMCRP Patents.  VFMCRP shall be responsible
([***]) for defending (including conducting any derivations, interferences,
reissue proceedings, cancellations, oppositions, post grant reviews and
reexaminations) and maintaining the VFMCRP Patent Rights, including all Patents
and Patent Applications claiming Inventions it solely owns under the Agreement
but excluding Joint Patents (which are addressed in Section 10.2(e)). At
minimum, VFMCRP shall maintain and defend VFMCRP Patent Rights [***] filing or
prosecuting VFMCRP Patent Rights.  If any of the VFMCRP Patent Rights or Patents
and Patent Applications claiming Inventions or Improvements solely owned by
VFMCRP under this Agreement  becomes the subject of any proceeding commenced by
a Third Party in the Licensed Territory (the Patents or Patent Applications
under challenge the “VFMCRP Challenged Patents”) in connection with an
opposition, reexamination request, action for declaratory judgment, nullity
action, interference or other attack upon the validity, title or enforceability
thereof (such an action a “Patent Challenge”), then VFMCRP shall have the right
to control such defense [***]. [***] such proceeding (but not to [***] of such
defense), [***] in any such action with respect to the VFMCRP Challenged Patents
that are included in the VFMCRP Patent Rights.  VFMCRP shall [***], and shall
[***] for such Patents and Patent Applications in the Licensed
Territory.  VFMCRP shall provide to Relypsa [***] relating to such maintenance
or defense activities [***].  VFMCRP shall not [***] during maintenance and
defense of such Patents or Patent Applications that would [***] the Patents or
Patent Applications (including [***]) in the Licensed Territory, without
[***].  If VFMCRP

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decides [***] of any VFMCRP Patent Rights in the Licensed Territory, VFMCRP
shall provide Relypsa with [***] at least [***] ([***]) days prior to any [***]
thereof.  In such event, if [***] of any such VFMCRP Patent Rights in the
Licensed Territory, VFMCRP [***], but Relypsa shall [***] such [***] provided
that [***] (for clarity, if [***]).

(e) Joint Patents.

(i) The Parties shall inform the JSC promptly after the conception of any
Invention that is owned jointly by the Parties pursuant to Section 10.1 and
provide to the JSC information with respect to such jointly owned Invention
reasonably necessary to enable the JSC to determine whether to file a Patent
Application thereon (any such Patent Application or Patent issuing therefrom, a
“Joint Patent”).  The JSC shall determine which Party shall be responsible,
[***], for the preparation, filing, prosecution (including conducting any
derivations, interferences, reissue proceedings, cancellations, oppositions,
post grant reviews and reexaminations), and maintenance of any and all Joint
Patents claiming or covering such Joint Invention (the selected Party, the
“Prosecuting Party”).  The Prosecuting Party shall reasonably consult with the
other Party, including providing draft responses to the other Party [***] prior
to the filing deadline, and shall consider in good faith any comments from the
other Party with respect to such preparation, filing, prosecution and
maintenance activities for such Joint Patent.  The Prosecuting Party shall
provide to such other Party copies of any papers relating to such filing,
prosecution, or maintenance activities for such Joint Patent promptly upon their
being filed or received.  The Prosecuting Party shall not knowingly take any
action during prosecution and maintenance of such Joint Patent that would
materially adversely affect such Joint Patent (including any reduction in claim
scope), without consultation with such other Party.  [***] related to the
preparation, filing, prosecution, and maintenance of any Joint Patents;
provided, however, that either Party may [***], in which case: (A) [***]; (B)
[***] [***]; and (C) [***].  

(ii) The Prosecuting Party shall prosecute and maintain each Joint Patent in at
least the following countries: [***] (each, a “Core Country”, and collectively,
the “Core Countries”).  For any Joint Patent filed with the European Patent
Office, the Parties will discuss and agree in which countries to validate the
granted Patent thereon depending on the scope and business value of the claims.
[***].  In no event will the Prosecuting Party permit Patents or Patent
Applications for which it is responsible under Section 10.2(e)(i) to be
abandoned in any Core Country, or elect not to file a new Patent Application
claiming priority to a Patent Application for which it is responsible under
Section 10.2(e)(i) in a Core Country either before such Patent Application’s
issuance or within the time period required for the filing of a divisional or
other continuing Patent Application or an international (e.g., Patent
Cooperation Treaty), regional (including with the European Patent Office), or
national Patent Application, unless the other Party is first given an
opportunity to assume full responsibility for the continued prosecution
(including the conduct of any derivations, interferences, reissue proceedings,
cancellations, oppositions, post grant reviews and reexaminations) and
maintenance of such Joint Patent, or the filing of any new Patent Application
that is a Joint Patent.  Each Prosecuting Party shall provide the other Party
with notice of the allowance and expected issuance date of any Joint Patent, and
any of the aforementioned filing deadlines, and such Prosecuting Party shall
provide such other Party with prompt notice as to whether it desires to file
such new Patent Application.  If the Prosecuting Party decides either: (A) not
to continue the prosecution or maintenance of a Patent Application or Patent
that is a Joint Patent in any country; or (B) not to file a new Patent
Application that is a Joint Patent requested to be filed by the non-Prosecuting
Party, the Prosecuting Party shall provide the non-Prosecuting Party with notice
of this decision at least [***] ([***]) days prior to any deadline or pending
lapse or abandonment thereof.  In such event, the Prosecuting Party shall
provide the non-Prosecuting Party with an opportunity to confer with the
Prosecuting Party regarding whether to pursue the filing and/or further
prosecution (including the conduct of any derivations,

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interferences, reissue proceedings, cancellations, oppositions, post grant
reviews and reexaminations) and maintenance of such Joint Patents.  If the
non-Prosecuting Party prefers to pursue such actions, the [***].  

(iii) If any of the Joint Patents becomes the subject of any proceeding
commenced by a Third Party in connection with an opposition, reexamination
request, action for declaratory judgment, nullity action, interference or other
attack upon the validity, title or enforceability thereof the Parties shall
confer and determine which Party shall control, and the allocation of costs with
respect to, such action.

(f) The Parties shall reasonably cooperate to file Patent Applications on
Inventions in a manner that will result in the ownership of all such Patent
Applications and Patents issuing therefrom being owned in the same manner in
which the claimed Inventions are owned as set forth in Section 10.1.  Each Party
shall ensure that, to the extent permitted by Applicable Laws, its employees,
licensees, sublicensees (if permitted), Affiliates, independent contractors,
consultants or agents performing work pursuant to this Agreement are under an
obligation to assign to it all Inventions and intellectual property therein
rights arising during and in the course of and as a result of the performance of
such work or, where such obligation is not permitted in a particular country, to
exclusively license to it all such Inventions and intellectual property rights,
with the right to authorize or grant sublicenses in such country, or where
neither of the foregoing obligations is permitted under Applicable Laws in a
particular country then, to non-exclusively license to it all such Inventions
and intellectual property rights, with the right to authorize or grant
sublicenses in such country.

(g) Relypsa shall use Commercially Reasonable Efforts to [***] in the Licensed
Territory (collectively “[***]”) for any Patent Rights licensed to VFMCRP under
this Agreement. VFMCRP shall execute such authorizations and other documents and
take such other actions as may be reasonably requested by Relypsa to obtain such
[***], including designating Relypsa as its agent for such purpose as provided
in 35 U.S.C. Section 156 and comparable foreign laws.  All filings for such
[***] shall be made by Relypsa; provided, Relypsa must reasonably consider
VFMCRP’s comments with respect thereto to ensure consistency between the
applicable [***] applications and other patent prosecution documents.  If
Relypsa elects not to file for a [***] in the Licensed Territory, Relypsa shall
promptly notify VFMCRP of its intention not to file.  If VFMCRP desires for the
[***] to be filed, Relypsa will grant VFMCRP to file such [***].  In that case,
VFMCRP must reasonably consider Relypsa’s comments with respect thereto to
ensure consistency between the applicable [***] applications and other patent
prosecution documents.  Each Party shall execute such authorizations and other
documents and take such other actions as may be reasonably requested by the
other Party to obtain such extensions. The Parties shall cooperate with each
other in gaining patent term restorations and/or extensions wherever applicable
to such Relypsa Patent Rights in the Territory.  The Parties shall cooperate
with each other in seeking and obtaining [***] in the Territory.  

(h) If in the Licensed Territory the equivalent of the “Approved Drug Products
with Therapeutic Equivalence Evaluations” (the “Orange Book”) permits the
listing of any Relypsa Patent, VFMCRP shall ensure that it: (a) maintains
correct and complete listings of all applicable Relypsa Patent Rights in such
listing system in accordance with Applicable Laws and advice of its intellectual
property and regulatory counsel and (b) enforces such listings in a timely
manner, each as applicable.  VFMCRP shall provide Relypsa with a reasonable
opportunity to review and comment on any such listings it submits to Regulatory
Authorities and must reasonably consider any comments provided by Relypsa.

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10.3 Infringement of Third Party Rights.

(a) Notice.  If the Development, manufacture, import, use, or sale of the
Product in the Licensed Territory results in a claim, action, suit or proceeding
arising out of an allegation that the manufacture, use or sale of Product, or
components thereof, in the Licensed

Territory and in the Field is alleged to infringe, or infringes, any Patents
controlled by a Third Party (an “Infringement Claim”), the Party first having
notice shall promptly notify the other Party in writing.  The notice shall set
forth the facts of the claim in reasonable detail.  The Parties shall promptly
confer regarding such claim.

(b) Infringement Claims in the Licensed Territory.  Subject to Section 10.3(c),
and subject to each Party’s rights or obligations under Article 13, if
applicable, the Party against whom an Infringement Claim is brought shall have
the right to settle and defend any such Infringement Claims, [***].  The Party
defending against such Infringement Claim (the “Defending Party”) shall have
full control over the defense and settlement of such Infringement Claim;
provided, however that any such settlement that could [***] to affect adversely
the other Party (the “Non-Defending Party”) shall require the Non-Defending
Party’s prior consent, not to be unreasonably withheld, delayed or
conditioned.  The Non-Defending Party shall cooperate with the Defending Party,
at the [***], in such defense and shall have the right to be represented by
counsel of its own choice in such matter, at the [***].  Where an Infringement
Claim is brought against both Relypsa and VFMCRP, the Parties shall confer and
reasonably cooperate in the defense and settlement of such claim.

(c) Challenge of Relypsa’s Patents.  Notwithstanding Section 10.3(b), if any
Infringement Claim includes, either as part of the initial Infringement Claim or
by way or counterclaim or any other action or proceeding arising in connection
with an Infringement Claim, any Patent Challenge to any of the Relypsa Patent
Rights or Patents and Patent Applications claiming Inventions solely owned by
Relypsa under Section 10.1, then Relypsa shall have the right to control the
part of the action in the Infringement Claim constituting or requiring a defense
by Relypsa of such a Patent Challenge.  Such defense shall be conducted in
accordance with Section 10.2(b), and the costs and recoveries shall be borne or
retained by Relypsa.

10.4 Third Party Licenses.

(a) If Third Party Patent Applications or Patents are identified by either Party
that [***] the [***] the Product in the Field, and the Parties agree that [***]
such identified Third Party Patent Applications or Patents (for Patent
Applications, assuming pending claims therein had issued) for the [***] of the
Product in the Field in the Licensed Territory (“Relevant Patents”), [***] shall
have the [***] to such Relevant Patents, [***], in order to permit
[***].  Subject to the foregoing, the terms and conditions involved in [***]
shall be determined [***], provided that it consults with [***] with respect to
the [***] and the [***].  If [***] under Relevant Patents, such Relevant Patents
will be included in the [***] Technology, and, [***] will pay any applicable
Third Party Payments.  If [***] elects [***] to such Relevant Patents, or is
[***] within [***] ([***]) days after electing to do so, then [***] shall have
the right (but not the obligation) to [***] within [***] from such Third Party
[***] (with [***]).  For clarity, [***] shall not [***] Relevant Patents in the
Licensed Territory until [***] has either [***] or [***], and [***] first
notifies [***] in writing that [***] intends to exercise its rights pursuant to
the immediately preceding sentence.

(b) If the Parties disagree on whether rights in Third Party Patent Applications
or Patents are Relevant Patents for purposes of Section 10.4(a), then [***]
shall have the right [***]. In the event that

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[***], then such intellectual property rights [***] will [***] unless the
Parties otherwise agree in writing. In the event that [***] obtains such
license, then [***]

(c) If Third Party Patent Applications or Patents are identified by either Party
that may be [***] of the Product in the Field in the Licensed Territory, but
[***] (“[***]), [***] shall have the first right to [***] such [***], and shall
use commercially reasonable efforts to [***] such [***].  The [***] shall
discuss such [***], including [***].  For the avoidance of doubt, any [***] will
[***].  

(d) If a court or governmental authority with competent jurisdiction has
determined in a final decision that a Patent owned by a Third Party is a
Relevant Patent, then Section 10.4(a) shall apply to a license under such
Relevant Patent. Any award to be paid by [***].

10.5 Infringement by Third Parties.  

(a) The Party having the first right to file, prosecute and maintain a
particular Patent or Patent Application in the Licensed Territory as set forth
in Section 10.2 shall have the first right, but not the obligation, to enforce
Patents issuing on such Patent Application worldwide, which includes the right
to control and settle the litigation (subject to the last sentence of this
Section 10.5).  The Party having the first right shall provide information about
its preliminary intention within [***] days after the Parties first learn of
such infringement.  The other Party shall have the right to enforce such Patents
against infringers to the extent such infringement relates to the manufacture,
use, or sale of products competitive with the Product in the Field in the
Licensed Territory, if the Party first having the right to do so does not
initiate an enforcement action within  [***] ([***]) days after the Parties
first learn of such infringement (or, for actions brought under the Drug Price
Competition and Patent Term Restoration Act of 1984, as amended, or the
equivalent of such Act in any country in the Licensed Territory, [***] ([***])
days after such date).  

(b) In the event that entry of a product to a market segment in which the
Product is sold in the Licensed Territory [***] and the making, using or selling
of the product in the Licensed Territory would infringe any Relypsa Patent
Rights, [***] shall take all reasonable actions to determine, within [***]
([***]) days of the date on which [***] first learns of such [***] or any longer
time period agreed by the Parties, whether [***] with regard to such [***] and
shall promptly inform [***].  If [***] does not take such action, [***] may take
such action.  

(c) In the event that entry of a product to a market segment in which the
Product is sold in the Licensed Territory [***] and the making, using or selling
of the product in the Licensed Territory would infringe any VFMCRP Patent
Rights, [***] shall take all reasonable actions to determine, within [***]
([***]) days of the date on which [***] first learns of such [***] or any longer
time period agreed by the Parties, whether [***] with regard to such [***] and
shall promptly inform [***].  If [***] does not take such action, [***] may take
such action.

(d) Expenses of proceedings, to the extent related to the manufacture, use, or
sale of Product in the Field in the Licensed Territory, shall be borne by the
enforcing Party.  Expenses of proceedings, to the extent related  to the
manufacture, use, or sale of Product in the Field outside the Licensed
Territory, shall be borne by the Party having the right to enforce such rights
under this Section 10.5. If the enforcing Party recovers monetary damages in
such claim, suit or action, such recovery shall be allocated first to [***] in
such litigation (including for this purpose, a reasonable allocation of [***]),
and any remaining amounts (including, for clarity, any amounts received as
royalty payments paid by the Third Party infringer) attributable to infringement
in the Licensed Territory shall [***], with amounts attributable to [***].

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(e) No settlement, consent judgment, or other voluntary final disposition of a
suit under this Section 10.5 that [***] may be entered into without the consent
of such other Party (which consent shall not be unreasonably withheld, delayed
or conditioned).  If one Party brings any action or proceeding under this
Section 10.5, the other Party [***] and to give the first Party reasonable
assistance and authority to file and prosecute the suit.  In such event, the
other Party shall have the right to be represented in such action or proceeding
by counsel of its own choice [***] in the prosecution of such action or
proceeding.  Neither Party shall have the right to settle any Patent
infringement litigation under this Section 10.5 in a [***] without the consent
of such other Party.

10.6 Infringement Outside the Field and Outside the Licensed Territory.  Relypsa
shall retain any and all rights to pursue an action against, and control all
proceedings relating to, an infringement by a Third Party of the Relypsa Patent
Rights that is not related to any product that is competitive with Products or
is solely outside the Field or outside the Licensed Territory.  VFMCRP shall
retain any and all rights to pursue an action against, and control all
proceedings relating to, an infringement by a Third Party of the VFMCRP Patent
Rights.

10.7 Further Actions.  Each Party shall cooperate with the other Party to
execute all documents and take all reasonable actions to effect the intent of
this Article 10.

11. Representations and Warranties

11.1 The Parties’ Representations and Warranties.  Each Party hereby represents
and warrants to the other Party, as of the Effective Date, as set forth below:

(a) Such Party: (i) is a corporation duly organized and subsisting under the
laws of its jurisdiction of organization; and (ii) has full power and authority
and the legal right to own and operate its property and assets and to carry on
its business as it is now being conducted and as it is contemplated to be
conducted by this Agreement.

(b) Such Party has sufficient legal and/or beneficial title or a license under
its intellectual property rights to grant the licenses or sublicenses contained
in this Agreement.

(c) To such Party’s knowledge, there is no pending or threatened litigation, and
such Party received any written communications, in each case alleging that it
has violated or would violate, through the manufacture, import and/or sale of
Product, or by conducting its obligations as currently proposed under this
Agreement, any intellectual property or other rights of any Third Party.

(d) To such Party’s knowledge, all of its employees, officers, independent
subcontractors, consultants, and agents who have performed or will perform
activities under this Agreement or with respect to the Product in the Field have
executed agreements requiring assignment to such Party of all inventions made
during the course of and as a result of their association with such Party and
obligating the individual to maintain as confidential the Confidential
Information of such Party.

(e) Such Party has the power, authority and legal right, and is free to enter
into this Agreement and, in so doing, will not violate any other agreement to
which such Party is a party as of the Effective Date in any material
respect.  Moreover, during the Term, such Party shall not enter into any
agreement with a Third Party that will conflict in any material respect with the
rights granted to the other Party under this Agreement.  

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(f) This Agreement has been duly executed and delivered on behalf of such Party
and constitutes a legal, valid, and binding obligation of such Party and is
enforceable against it in accordance with its terms, subject to the effects of
bankruptcy, insolvency, or other laws of general application affecting the
enforcement of creditor rights and judicial principles affecting the
availability of specific performance and general principles of equity.

(g) Such Party has taken all corporate action necessary to authorize the
execution and delivery of this Agreement.

(h) Neither such Party, nor any of such Party’s employees, officers, independent
contractors, consultants, or agents who will render services relating to the
Product:  (i) has ever been debarred or is subject to debarment or convicted of
a crime for which an entity or person could be debarred under 21 U.S.C. Section
335a (or its equivalent under Applicable Laws); or (ii) has ever been under
indictment for a crime for which a person or entity could be debarred under said
Section 335a (or its equivalent under Applicable Laws).  If during the Term, a
Party has reason to believe that it or any of its employees, officers,
independent contractors, consultants, or agents rendering services relating to
the Products: (x) is or will be debarred or convicted of a crime under 21 U.S.C.
Section 335a (or its equivalent under Applicable Laws); or (y) is or will be
under indictment under said Section 335a (or its equivalent under Applicable
Laws), then such Party shall immediately notify the other Party of same in
writing.

(i) Such Party has obtained all necessary consents, approvals, and
authorizations of all Regulatory Authorities and other Third Parties required to
be obtained by such Party in connection with the execution and delivery of this
Agreement and the performance of its obligations hereunder.

(j) The execution and delivery of this Agreement and the performance of such
Party’s obligations hereunder: (i) do not and shall not conflict with or violate
any requirement of Applicable Laws or any provision of the articles of
incorporation, bylaws, limited partnership agreement, or any similar instrument
of such Party, as applicable, in any material way; and (ii) do not and shall not
conflict with, violate, or breach or constitute a default or require any consent
under, any Applicable Laws or any contractual obligation or court or
administrative order by which such Party is bound.

(k) [***], such Party has not entered into and, during the Term, shall not enter
into any agreement with a Third Party that would [***] rights or licenses
granted to the other Party under this Agreement.

11.2 Relypsa's Representations and Warranties. Relypsa hereby represents and
warrants to VFMCRP, as of the Effective Date, as set forth below:

(a) Exhibit 11.2 contains a complete and accurate list of Relypsa Patent Rights
existing as of [***].

(b) The status of each of the Relypsa Patent Rights listed on Exhibit 11.2, as
set forth on Exhibit 11.2, is accurate in all material respects, and to
Relypsa’s knowledge, none of such issued Relypsa Patent Rights have been subject
to [***].

(c) Relypsa or its Affiliates own all right, title and interest in and to the
Relypsa Patent Rights; and Relypsa or its Affiliates own all right, title and
interest in and to the Relypsa Know-How or have appropriate licenses to Relypsa
Know-How.    

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(d) The Relypsa Technology in the Licensed Territory is free and clear of all
liens, claims, charges and encumbrances by Third Parties.

(e) To Relypsa’s knowledge, the Relypsa Technology constitutes all Information,
Patents and Patent Applications that are [***] Develop, make and have made
(subject to Article 8), use, sell, offer for sale, import and export and
otherwise Commercialize Products in the Field and in the Licensed Territory, as
such Products exist as of the Effective Date.

11.3 VFMCRP's Representation and Warranty.  VFMCRP hereby represents and
warrants to Relypsa, up to and including the Effective Date, that VFMCRP and its
Affiliates do not own any patents, patent applications or other intellectual
property rights that would be infringed as a result of the exploitation of the
Product.

12. Non-Solicitation of Employees.

12.1 Non-Solicitation. While the Parties are performing Development activities
under this Agreement, and for a period of [***] thereafter, neither Party shall,
without the express written consent of the other Party, solicit, or induce any
employee of the other Party to terminate his or her employment with such other
Party.  The foregoing provision shall not, however, restrict either Party or its
Affiliates from advertising employment opportunities in any manner that does not
directly target the other Party or its Affiliates or from hiring any persons who
respond to such generalized public advertisements.  

13. Mutual Indemnification and Insurance.

13.1 Relypsa’s Right to Indemnification.  VFMCRP shall indemnify, defend, and
hold harmless Relypsa and its Affiliates, and their respective employees,
officers, independent contractors, consultants, or agents, and their respective
successors, heirs and assigns and representatives (the “Relypsa Indemnitees”),
from and against any and all claims, threatened damages, losses, suits,
proceedings, liabilities, costs (including reasonable legal expenses, costs of
litigation, and reasonable attorney’s fees) or judgments, whether for money or
equitable relief, of any kind arising from Third Party claims (“Losses and
Claims”), to the extent arising out of or relating to, directly or indirectly:
(a) the negligence, gross negligence, or willful misconduct of VFMCRP or its
Affiliates, and their respective employees, officers, independent contractors,
consultants, Sublicensees, Distributors, Wholesalers or agents, in connection
with VFMCRP’s performance of its obligations or exercise of its rights under
this Agreement; (b) any breach by VFMCRP of any representation, warranty,
covenant, or obligation set forth in this Agreement (including without
limitation Section 17.12); and (c) the Development, manufacture, or
Commercialization (including promotion, advertising, offering for sale, sale, or
other disposition), transfer, importation or exportation, labeling, handling or
storage, or use of, or exposure to, any Product conducted by or for VFMCRP or
any of its Affiliates, agents, consultants, Sublicensees, Distributors, [***],
Wholesalers and independent contractors (but not Relypsa); except to the extent
any Losses and Claims are attributable to any negligence, gross negligence,
willful misconduct, or breach of this Agreement or the Manufacturing and Supply
Agreement by a Relypsa Indemnitee.

13.2 VFMCRP’s Right to Indemnification.  Relypsa shall indemnify, defend, and
hold harmless VFMCRP and its Affiliates, and their respective employees,
officers, independent contractors, consultants, or agents, and their respective
successors, heirs and assigns and representatives (the “VFMCRP Indemnitees”),
from and against any and all Losses and Claims, to the extent arising out of or
relating to, directly or indirectly: (a) the negligence, gross negligence, or
willful misconduct of Relypsa, its Affiliates, and/or its sublicensees and its
or their respective employees, officers, independent contractors, consultants,

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Sublicensees, Distributors, Wholesalers or agents, in connection with Relypsa’s
performance of its obligations or exercise of its rights under this Agreement;
(b) any breach by Relypsa of any representation, warranty, covenant, or
obligation set forth in this Agreement (including without limitation Section
17.12); (c) the Development or Commercialization (including the promotion,
advertising, offering for sale, sale, or other disposition), transfer,
importation or exportation, labeling, handling or storage, or use of, or
exposure to, any Product conducted by or for Relypsa or any of its Affiliates,
sublicensees (other than VFMCRP and its Affiliates), agents, consultants,
Sublicensees, Distributors, Wholesalers, and independent contractors outside the
Licensed Territory or within the Licensed Territory for purposes of Developing
or Commercializing Products outside the Licensed Territory; except to the
extents any Losses and Claims are attributable to any negligence, gross
negligence, willful misconduct, or breach of this Agreement by a VFMCRP
Indemnitee.

13.3 Process for Indemnification.  A Party’s obligation to defend, indemnify and
hold harmless the other Party under this Article 13 shall be conditioned upon
the following:

(a) A Party seeking indemnification under this Article 13 (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 Losses and Claims.  The
Indemnified Party shall cooperate as requested by the Indemnifying Party in the
defense against any Losses and 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; provided, however, 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
13.3(c), 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 which would: (i) [***]; (ii)
require any [***]; (iii) require [***]; or (iv) effect [***], in each case
without the prior written consent of the Indemnitee, which consent shall not be
unreasonably withheld, delayed or conditioned.  The Indemnitee shall reasonably
cooperate with the Indemnitor at the 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 14.

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

13.4 Insurance.  During the Term, and for a period of [***] ([***]) Years
thereafter, each Party shall carry and maintain the following product liability
insurance amounts to cover any liability that may arise under this Agreement or
as required by Applicable Laws: (a) prior to [***], not less than [***] Dollars
($[***]) coverage; and (b) after [***], not less than [***] Dollars ($[***])
coverage.  It is understood that such insurance shall not be construed to create
a limit of either Party’s liability with respect to its indemnification
obligations under this Article 13.  Each Party shall use Commercially Reasonable
Efforts to provide the other Party with thirty (30) days prior written notice of
any material modification of its insurance policy.

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14. Confidentiality

14.1 Confidentiality.  For the Term, and for a period of [***] ([***]) Years
thereafter, each Party shall maintain in confidence all Information and
materials of the other Party disclosed or provided to it by the other Party
(either pursuant to this Agreement, or the Confidential Disclosure Agreement
entered into by the Parties effective as of May 6, 2014, as amended (the
“Confidential Disclosure Agreement”)) (together with all embodiments thereof,
the “Confidential Information”).  Confidential Information also includes
Information generated hereunder, and Information regarding intellectual property
and confidential or proprietary Information of Third Parties, in each case as
described by a Party to the other Party, and the terms of this Agreement.  In
addition, and notwithstanding the foregoing, if under Section 10.1, Information
constituting inventions and discoveries are to be owned by one Party, such
Information shall be deemed to be Confidential Information disclosed by such
Party and received by the other Party, even if such Information is initially
generated and disclosed by the other Party.  The terms and conditions of this
Agreement and the Confidential Disclosure Agreement also shall be deemed
Confidential Information of both Parties.

14.2 Degree of Care; Permitted Use.  Each Party shall maintain, and shall use
Commercially Reasonable Efforts to cause its employees to maintain, the
confidentiality of the Confidential Information of the other Party, which steps
shall be no less protective than those steps that such Party takes to protect
its own Confidential Information of a similar nature and shall, in no event, be
less than a reasonable degree of care.  Neither Party shall use or permit the
use of any Confidential Information of the other Party except for the purposes
of carrying out its obligations or exercising its rights under this Agreement,
and neither Party shall copy any Confidential Information of the other Party
except as may be reasonably necessary or useful for such purposes.  All
Confidential Information of a Party, including all copies and derivations
thereof, is and shall remain the sole and exclusive property of the disclosing
Party and subject to the restrictions provided for herein.  Subject to Sections
14.3 and 14.4, neither Party shall disclose any Confidential Information of the
other Party other than to those of its directors, officers, Affiliates,
employees, actual or potential licensors, independent contractors, actual or
potential licensees or permitted sublicensees, actual or potential assignees,
agents, (and in the case of VFMCRP, to [***]) and external advisors directly
involved in or concerned with the carrying out of this Agreement, on a strictly
applied “need to know” basis; provided, however, that such persons and entities
are subject to confidentiality and non-use obligations at least as stringent as
the confidentiality and non-use obligations provided for in this Article
14.  Except to the extent expressly permitted under this Agreement, the
receiving Party may not use Confidential Information of the other Party in
filing for Patent Applications or securing other intellectual property rights
without first consulting with, and obtaining the written approval of, the other
Party (which approval shall not be unreasonably withheld, delayed or
conditioned).

14.3 Exceptions.  The obligations of confidentiality and non-use set forth in
Section 14.2 shall not apply to any portion of Confidential Information that the
receiving Party can demonstrate by contemporaneous written records was: (a)
known to the general public at the time of its disclosure to the receiving
Party, or thereafter became generally known to the general public, other than as
a result of actions or omissions of the receiving Party or anyone to whom the
receiving Party disclosed such portion; (b) lawfully acquired by the receiving
Party prior to the date of disclosure by the disclosing Party and not under any
duty of confidentiality; (c) disclosed to the receiving Party on an unrestricted
basis from a Third-Party source unrelated to the disclosing Party and not under
a duty of confidentiality or non-use to the disclosing Party; or (d)
independently developed by the receiving Party by personnel that did not have
access to or use of Confidential Information of the disclosing Party.  Any
combination of features or disclosures shall not be deemed to fall within the
foregoing exclusions merely because individual features are published or known
to the general public

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or in the rightful possession of the receiving Party unless the combination
itself are published or known to the general public or are in the rightful
possession of the receiving Party.

14.4 Permitted Disclosures.  The obligations of confidentiality and non-use set
forth in Section 14.2 shall not apply to the extent that the receiving Party:
(a) is required to disclose Information pursuant to: (i) an order of a court or
governmental agency of competent jurisdiction, (ii) Applicable Laws (iii)
regulations or rules of a securities exchange, including, without limitation, as
required in connection with a public offering of a Party’s stock or to comply
with regulations imposed by the United States Securities and Exchange
Commission, NASDAQ or any other applicable stock exchange disclosure
requirements), (iv) if in the reasonably opinion of receiving Party's legal
counsel, such disclosure is necessary for compliance with any of the foregoing;
(v) the requirement of a governmental agency for purposes of obtaining approval
to test or market the Product as contemplated in this Agreement; or (vi) the
requirements of a patent office for the purposes of filing a Patent Application
as permitted in this Agreement or as necessary for the purposes of prosecuting a
Patent as permitted in this Agreement; provided that, in the case of (a)(i)
through (v), the receiving Party shall provide prior written notice thereof to
the disclosing Party and reasonable opportunity (where practicable) for the
disclosing Party to review and comment on such required disclosure and request
confidential treatment thereof or a protective order therefor.  If this
Agreement must be publicly filed to comply with Applicable Laws or regulations
or rules of a securities exchange, including as required in connection with a
public offering of a Party’s stock or to comply with regulations imposed by the
United States Securities and Exchange Commission, NASDAQ or stock exchange
disclosure requirements, then the Party filing the Agreement shall use
reasonable efforts to seek confidential treatment of the Agreement and shall
seek the review and comment of the other Party with respect to proposed
redactions.

14.5 Return of Confidential Information.  Each Party shall return all
Confidential Information of the other Party in its possession upon termination
or expiration under this Agreement, or destroy such Confidential Information, at
the disclosing Party’s election and written request; provided, however that a
Party may retain (i) Confidential Information of the other Party if its license
thereto survives pursuant to this Agreement and (ii) one (1) copy of the
Confidential Information in archives solely for the purpose of establishing the
contents thereof.  The receiving Party shall provide a written confirmation of
such destruction within [***] ([***]) days after such destruction; provided that
the foregoing shall not apply to any Confidential Information that is necessary
to allow such Party to perform its obligations or exercise any of its rights
that expressly survive the termination or expiration of this Agreement.

14.6 Public Disclosure Publications.  The Parties agree that the initial public
announcement of the execution of this Agreement shall be in the form of a press
release that is attached to this Agreement as Exhibit 14.6 (the “Press
Release”).  During the Term, in all cases other than the announcement set forth
in the Press Release, VFMCRP shall submit to Relypsa for review and approval all
proposed press releases, filings with securities exchanges, academic,
scientific, and medical publications and public presentations relating to the
Product that have not been previously disclosed that are to be published by
VFMCRP or its Affiliates.  Such review and approval shall be conducted for the
purposes of preserving intellectual property protection and determining whether
any portion of the proposed publication or presentation containing the
Confidential Information of Relypsa should be modified or deleted, and to
determine whether such disclosure is in the best interests of the Parties in
connection with the Development and Commercialization of the Products in the
Licensed Territory.  Written copies of such proposed publications and
presentations (other than press releases) shall be submitted to Relypsa no later
than [***] ([***]) days before submission for publication or
presentation.  Subject to Applicable Laws and the regulations or rules of a
securities exchange that may require such disclosure to be made in a shorter
time period, written copies of proposed press releases shall be submitted to

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Relypsa no later than [***] before release.  Relypsa shall provide its comments,
if any, and (if Relypsa so chooses) its approval (which shall not be
unreasonably withheld) within: (a) [***], in the case of a press release, and
(b) [***] ([***]) days of its receipt of any other written copy.  With respect
to matters other than press releases, the review period may be extended for an
additional [***] ([***]) days in the event Relypsa can demonstrate reasonable
need for the preparation and filing of Patent Applications.  Such review period
may be further extended by mutual written agreement of the  Parties.  During the
Term, in all cases other than the announcement set forth in the Press Release,
Relypsa shall submit to VFMCRP for review all proposed press releases, academic,
scientific, and medical publications and public presentations relating to the
Product or this Agreement that have not been previously disclosed, that are to
be published by Relypsa or its Affiliates, and that could impact the Development
or Commercialization of the Products in the Field in the Licensed Territory in
any material respect.  Relypsa shall use [***] to provide written copies of such
proposed press releases, publications and presentations to VFMCRP at least [***]
before [***] or [***] ([***]) days before submission for publication or
presentation; subject to Applicable Laws and the regulations or rules of a
securities exchange that may require such disclosure to be made in a shorter
time period.

14.7 [***].  With regard to [***], the Parties agree that [***]. Accordingly,
the Parties agree that [***].

15. Term and Termination

15.1 Term.  

(a) The Term shall commence as of the Effective Date and, unless sooner
terminated as specifically provided in this Agreement, shall continue in effect
on a country-by-country and Product-by-Product basis until the expiration of all
payment obligations under Article 7 with respect to each Product in each country
in the Licensed Territory (“Term”).  Upon the expiration of the Term with
respect to a Product in a country, VFMCRP shall have a fully-paid, royalty-free
(subject to Section 15.1(b)), perpetual and non-exclusive license (with right to
grant sublicenses to permitted sublicensees) to manufacture (subject to Article
8), Develop, import, market, promote, use, offer for sale and sell the Product
in such country.

(b) If VFMCRP or its Affiliates or permitted sublicensees use the Product
Trademark after the expiry of this Agreement in connection with Product in the
Field in the Licensed Territory, then VFMCRP shall be required to pay to Relypsa
a royalty of [***] percent ([***]%) of any future Net Sales with respect to
those Products with which the Product Trademark is used or on which the Product
Trademark is displayed.

15.2 Termination by VFMCRP.  VFMCRP may terminate this Agreement without cause
upon at least one hundred eighty (180) days prior written notice to
Relypsa.  Following termination by VFMCRP under this Section 15.2:

(a) All licenses granted to VFMCRP by Relypsa shall terminate, and all rights in
and to the Products in the Licensed Territory shall revert to Relypsa.

(b) VFMCRP shall transfer to Relypsa, at [***], all relevant and necessary
materials, results, analyses, reports, the URL for Product-specific websites,
Product Data, technology, know-how, regulatory filings, and other Information in
whatever form developed, Controlled, or generated as of the effective date of
such termination by or on behalf of VFMCRP or its Affiliates with respect to
Products, except [***] but including [***].  [***] shall submit to any and all
Regulatory Authorities in jurisdictions in which any

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regulatory filings have been made with respect to the Products, within [***]
([***]) days after the effective date of such termination, a letter (with a copy
to [***]) notifying such Regulatory Authorities of the transfer of any
regulatory filings for a Product in such jurisdictions from [***].  

(c) VFMCRP’s exclusivity obligations under Section 2.4 shall survive for a
period of [***] ([***]) year after the effective date of such termination.  All
other obligations that expressly survive such termination (including obligations
with respect to Information) pursuant to Section 15.8 shall survive.

15.3 Termination for Insolvency.

(a) Either Party may terminate this Agreement immediately upon written notice to
the other Party, if, at any time: (a) the other Party files in any court or
agency pursuant to any statute or regulation of any state or country, a petition
in bankruptcy or insolvency or for reorganization or for an arrangement or for
the appointment of a receiver or trustee of the Party or of substantially all of
its assets; (b) the other Party is served with an involuntary petition against
it, filed in any insolvency proceeding, and such petition shall not be dismissed
within [***] ([***]) days after the filing thereof; (c) the other Party shall
propose or be a party to any dissolution or liquidation; or (d) the other Party
shall make an assignment of substantially all of its assets for the benefit of
creditors.  To the extent permitted under Law, all rights and licenses granted
under or pursuant to any Section of this Agreement, including any option to
receive a license, are and shall otherwise be deemed to be for purposes of
Section 365(n) of Title 11, United States Code (the “Bankruptcy Code”) licenses
of rights to “intellectual property” as defined in the Bankruptcy Code.  The
Parties shall retain and may fully exercise all of their respective rights and
elections under the Bankruptcy Code.

(b) Following a termination by VFMCRP under this Section 15.3:

(i) All licenses granted to VFMCRP under this Agreement shall survive and remain
in force.

(ii) VFMCRP shall continue to make milestone and royalty payments to Relypsa as
if the Agreement remained in force; provided, however the royalty rates in
Section 7.3 shall each be reduced as follows: to [***] ([***]%) from [***]
percent ([***]%); to [***] percent ([***]%) from [***] percent ([***]%); and to
[***] percent ([***]%) from [***] ([***]%), respectively; in addition, any
royalties due shall be reduced by [***].  

(iii) Relypsa’s exclusivity obligations under Section 2.4 shall survive for a
period of [***].  

(iv) All other obligations that expressly survive such termination (including
obligations with respect to Information) pursuant to Section 15.8 shall survive,
except VFMCRP shall [***].

(v) All licenses granted under Section 2.2(b) of this Agreement to Relypsa shall
survive, but solely outside the Licensed Territory.

(c) Following a termination by Relypsa under this Section 15.3:

(i) All licenses granted to VFMCRP by Relypsa shall terminate; provided,
however, that VFMCRP, its Affiliates or their respective permitted sublicensees
shall be permitted to sell,

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subject to the payment of applicable royalties due under Article 7, any Products
in inventory (including completion for sale of any work in progress) over the
[***] period following termination.

(ii) All rights in and to the Products in the Licensed Territory shall revert to
Relypsa.

(iii) VFMCRP shall transfer to Relypsa, [***], all relevant and necessary
materials, results, analyses, reports, Product Data, technology, know-how,
regulatory filings, and other Information in whatever form developed,
Controlled, or generated as of the effective date of such termination by or on
behalf of VFMCRP or its Affiliates with respect to Products, including [***] but
excluding [***].  [***] shall submit to any and all Regulatory Authorities in
jurisdictions in which any regulatory filings have been made with respect to the
Products, within [***] ([***]) days after the effective date of such
termination, a letter (with a copy to [***]) notifying such Regulatory
Authorities of the transfer of any regulatory filings for a Product in such
jurisdictions from [***]; provided that [***].

(iv) VFMCRP’s exclusivity obligations under Section 2.4 shall survive for a
period of [***].  

(v) All other obligations that expressly survive such termination (including
obligations with respect to Information) pursuant to Section 15.8 shall survive.

15.4 Termination for Material Breach.  Except as otherwise expressly provided in
Section 15.5 for breach by VFMCRP of certain diligence obligations, either Party
(the “Non-Breaching Party”) may terminate the Agreement for a material breach by
the other Party (the “Breaching Party”) that remains uncured for [***] ([***])
days (or, for a material breach of a payment obligation, [***] ([***]) days)
after the receipt by the Breaching Party of written notice specifying the
breach, provided that for any material breach that is not a material breach of a
payment obligation and is not curable within such [***] ([***]) day period, that
the Non-Breaching Party may not terminate this Agreement for such material
breach if the Breaching Party, commencing within [***] ([***]) days after its
receipt of written notice specifying the breach and continuing thereafter until
such cure is effected, uses reasonable efforts to cure such breach in accordance
with a plan reasonably acceptable to the Non-Breaching Party.  Notwithstanding
the foregoing, if a Party commits material breach of this Agreement that is not
curable, such the other Party shall have the right to terminate this Agreement
immediately by written notice to such Party.

(a) Following a termination by VFMCRP under this Section 15.4:

(i) VFMCRP shall have the right to elect to retain all the licenses granted to
VFMCRP pursuant to Section 2.1, and other rights in the Products granted to
VFMCRP in the Field and in the Licensed Territory pursuant to this Agreement, in
which case VFMCRP shall: (A) continue Development of the Products; and (B) make
milestone and royalty payments to Relypsa, in each case in accordance with
subsection (ii) of this Section 15.4(a).  If VFMCRP does not make the foregoing
election, then subject to subsection (iv) of this Section 15.4(a): (1) all
licenses granted to VFMCRP under this Agreement shall terminate; (2) all rights
in and to the Products in the Licensed Territory shall revert to Relypsa; (3)
VFMCRP shall transfer to Relypsa [***] all relevant and necessary materials,
results, analyses, reports, Product Data, the URL for Product-specific websites,
technology, know-how, regulatory filings, and other Information in whatever form
developed, Controlled, or generated as of the effective date of such termination
by or on behalf of VFMCRP or its Affiliates with respect to Products, but
excluding [***]; and (4) [***] shall submit to any and all Regulatory
Authorities in jurisdictions in which any regulatory filings have been made with
respect to the Products, within [***]

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([***]) days after the effective date of such termination, a letter (with a copy
to [***]) notifying such Regulatory Authorities of the transfer of any
regulatory filings for a Product in such jurisdictions from [***]; provided that
[***].

(ii) If VFMCRP elects to retain the licenses granted hereunder in accordance
with the foregoing subsection (i): (A) [***]; and (B) VFMCRP shall continue to
make milestone and royalty payments to Relypsa pursuant to  Article 7 on Net
Sales of Products in the Licensed Territory, on a country-by-country and
Product-by-Product basis until the expiration of a period equal to a time period
that would have been the Royalty Term set forth in Section 7.4 for each relevant
country, had the Agreement not been terminated; provided, however that royalties
payable by VFMCRP shall be reduced by [***] percent ([***]%) of those otherwise
due to Relypsa; provided that in no event shall the foregoing reduction, alone
or together with any other reductions, credits or offsets available to VFMCRP
pursuant to this Agreement, result in royalties payable to Relypsa of less than
[***] percent ([***]%) of Net Sale of Products in the Licensed Territory.

(iii) In the case of any termination by VFMCRP under this Section 15.4, whether
or not VFMCRP elects to retain the licenses granted hereunder, Relypsa’s
exclusivity obligations under Section 2.4 shall survive for a period of [***].  

(iv) All other obligations that expressly survive such termination (including
obligations with respect to Information) pursuant to Section 15.8 shall survive,
except VFMCRP shall [***].

(v) All licenses granted under Section 2.2(b) of this Agreement shall terminate
if VFMCRP does not elect to retain the licenses granted hereunder in accordance
with the foregoing subsection (i).

(b) Following a termination by Relypsa under this Section 15.4, subject to
Section 15.5:

(i) All licenses granted to VFMCRP by Relypsa shall terminate; provided,
however, that VFMCRP, its Affiliates or their respective permitted sublicensees
shall be permitted to sell, subject to the payment of applicable royalties due
under Article 7, any Products in inventory (including completion for sale of any
work in progress) over the [***] period following termination.

(ii) All rights in and to the Products in the Licensed Territory shall revert to
Relypsa;

(iii) VFMCRP shall transfer to Relypsa, [***], all relevant and necessary
materials, results, analyses, reports, Product Data, technology, know-how,
regulatory filings, and other Information in whatever form developed,
Controlled, or generated as of the effective date of such termination by or on
behalf of VFMCRP or its Affiliates with respect to Products, including Product
Inventions but excluding Existing [***] Technology.  [***] shall submit to any
and all Regulatory Authorities in jurisdictions in which any regulatory filings
have been made with respect to the Products, within [***] ([***]) days after the
effective date of such termination, a letter (with a copy to [***]) notifying
such Regulatory Authorities of the transfer of any regulatory filings for a
Product in such jurisdictions from [***].

(iv) VFMCRP’s exclusivity obligations under Section 2.4 shall survive for a
period of [***].  

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(v) All other obligations that expressly survive such termination (including
obligations with respect to Information) pursuant to Section 15.8 shall survive.

15.5 Termination for Material Breach of Diligence Requirements.

(a) With respect to a breach of the diligence requirements in Sections 4.2,
5.1(b) and/or 6.2(a) with respect to the [***], a breach will be material for
purposes of termination under Section 15.4 only if VFMCRP has failed to use
Commercially Reasonable Efforts to Develop, obtain Regulatory Approval of and/or
Commercialize the Product in the Field in at least [***] and such failure in the
[***] has a [***].  If Relypsa terminates this Agreement pursuant to Section
15.4 for material breach of VFMCRP’s obligations under Sections 4.2, 5.1(b)
and/or 6.2(a) as provided in this section, then Relypsa would be entitled to
terminate this Agreement [***].  In such case, [***] and [***].  

(b) With respect to a breach of the diligence requirements in Sections 4.2,
5.1(c) and/or 6.2(b) with respect to the [***], a breach will be material for
purposes of termination under Section 15.4 only if VFMCRP has failed to use
Commercially Reasonable Efforts to Develop, obtain Regulatory Approval for
and/or Commercialize the Product in the Field in each such [***].  If Relypsa
terminates this Agreement pursuant to Section 15.4 for material breach of
VFMCRP’s obligations under Sections 4.2, 5.1(c) and/or 6.2(a), then Relypsa
would be entitled to terminate this Agreement [***].  In such case, the [***]
[***] and [***].

(c) Relypsa’s rights and VFMCRP’s obligations under Section 15.4(b) shall [***].

15.6 Termination for Patent Challenge.  To the extent permitted by Applicable
Law, including, without limitation, applicable antitrust laws, Relypsa shall
have the right to terminate this Agreement immediately upon written notice if
VFMCRP, its Affiliates or their respective permitted sublicensees challenges the
validity or enforceability of or otherwise opposes any Patent included in the
Relypsa Patent Rights; provided, however, Relypsa shall not have a right to
terminate if the challenge is brought by a permitted sublicensee and VFMCRP or
the Affiliate, as the case may be, terminates such sublicensee’s sublicense
rights hereunder.  If Relypsa terminates this Agreement under this Section 15.6:

(a) All licenses granted to VFMCRP by Relypsa shall terminate; provided,
however, that VFMCRP, its Affiliates or their respective permitted sublicensees
shall be permitted to sell, subject to the payment of applicable royalties due
under Article 7, any Products in inventory (including completion for sale of any
work in progress) over the [***] period following termination.

(b) All rights in and to the Products in the Licensed Territory shall revert to
Relypsa.

(c) VFMCRP shall transfer to Relypsa, [***] all relevant and necessary
materials, results, analyses, reports, Product Data, technology, know-how,
regulatory filings, and other Information in whatever form developed,
Controlled, or generated as of the effective date of such termination by or on
behalf of VFMCRP, its Affiliates with respect to Products, including Product
Inventions but excluding Existing [***] Technology, and [***] shall submit to
any and all Regulatory Authorities in jurisdictions in which any regulatory
filings have been made with respect to the Products, within [***] ([***]) days
after the effective date of such termination, a letter (with a copy to [***])
notifying such Regulatory Authorities of the transfer of any regulatory filings
for the Product in such jurisdictions from [***], and

(d) VFMCRP’s exclusivity obligations under Section 2.4 shall survive for a
period of [***].

 

 

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(e) All other obligations that expressly survive such termination (including
obligations with respect to Information) pursuant to Section 15.8 shall survive.

15.7 Performance During Notice Periods.  During any notice period prior to the
effective date of any termination under this Article 15, each Party shall be
obligated to continue to perform all of such Party’s obligations hereunder.

15.8 Accrued Rights; Other Surviving Obligations.  Termination or expiration of
this Agreement for any reason shall not relieve either Party from obligations
that are expressly indicated to survive termination or expiration of the
Agreement.  Termination by a Party shall not be an exclusive remedy and all
other remedies will be available to the terminating Party, in equity and at
law.  In addition to the rights and obligations set forth in Sections 15.1 to
15.6 above that survive termination, termination of this Agreement shall not
terminate VFMCRP’s obligation to pay all milestone payments, royalties and other
payments which shall have accrued hereunder (including any milestone payments
then accrued because the event has occurred but the milestone payment is not yet
due) prior to the effective date of such termination.  Article 1 (Definitions),
Section 2.2(b) (as modified in Article 15), Section 2.4 (to the extent specified
in Article 15), Section 2.9 (to the extent rights under Section 2.2 survive),
Article 7 (Payment Obligations) (but with respect to any payment obligations, to
the extent payments payable thereunder have accrued but remain unpaid), Article
9 (Record Keeping, Record Retention and Audits), Article 10 (Inventions,
Know-How and Patents), Article 12 (Non-Solicitation of Employees), Article 13
(Mutual Indemnification and Insurance), Article 14 (Confidentiality), Article 16
(Exclusion of Damages; Disclaimer of Warranty), Article 17 (Miscellaneous),
Sections 7.7 to 7.11, and this Section 15.8 (Termination), of this Agreement
shall survive the termination or expiration of this Agreement.

16. Exclusion of Damages; Disclaimer of Warranty.

16.1 EXCEPT IN THE CASE OF A BREACH OF ARTICLE 14, AND WITHOUT LIMITING THE
PARTIES’ OBLIGATIONS UNDER ARTICLE 13, NEITHER PARTY SHALL BE LIABLE TO THE
OTHER PARTY FOR SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE, OR CONSEQUENTIAL
DAMAGES (INCLUDING WITHOUT LIMITATION 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.

16.2 EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER PARTY PROVIDES ANY
WARRANTIES, WHETHER WRITTEN OR ORAL, EXPRESS OR IMPLIED, REGARDING THE PRODUCT
OR ITS COMPONENTS, AND EACH PARTY HEREBY DISCLAIMS ALL OTHER WARRANTIES, WHETHER
WRITTEN OR ORAL, EXPRESS AND IMPLIED, INCLUDING WITHOUT LIMITATION THE IMPLIED
WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND FREEDOM
FROM INFRINGEMENT OF THIRD PARTY RIGHTS.

17. Miscellaneous.

17.1 Independent Contractors.  Each Party shall act solely as an independent
contractor, and nothing in this Agreement shall be construed to give either
Party the power or authority to act for, bind, or commit the other Party in any
way.  For clarity, neither Party shall be entitled to enter into any contracts
in the name of, or on behalf of the other Party, nor shall either Party be
entitled to pledge the credit of the other Party in any way or hold itself out
as having the authority to do so.

 

 

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17.2 Assignment.  Neither this Agreement nor any interest hereunder shall be
assignable by any Party without the prior written consent of the other Party
(which consent shall not be unreasonably withheld, delayed or conditioned);
provided, however, either Party, without such consent, may assign its rights and
delegate its duties hereunder to: (a) to any Third Party with which it merges or
consolidates, or to which it transfers all or substantially all of its assets to
which this Agreement relates; and (b) its Affiliate without obtaining such
consent, provided that the assigning Party agrees to remain primarily liable for
the full and timely performance by such Affiliate of all its obligations
hereunder; and further provided that if [***], such assignment shall be subject
to such other Party's prior written consent, which shall not be unreasonably
conditioned, delayed or denied (provided that [***]).  This Agreement shall be
binding upon and inure to the successors and permitted assignees of the Parties
and the name of a Party appearing herein shall be deemed to include the names of
such Party’s successor’s and permitted assigns to the extent necessary to carry
out the intent of this Agreement.  Any assignment not in accordance with this
Section 17.2 shall be null and void.  Notwithstanding anything in this Agreement
to the contrary, the Patent Application, Patents, Information, Trademarks, other
intellectual property rights owned or otherwise Controlled, as of the effective
date of the Change of Control of a Party or its Affiliates, by (i) any
counterparty with respect to a Change of Control (the “Acquirer”) of such Party
or its Affiliates (the “Acquired Party”) or (ii) any of Acquirer’s Affiliates
that are not Affiliates of the Acquired Party, in each case immediately prior to
the closing of such transaction(s) shall not become subject to the license
grants, assignments, reports, disclosures and other requirements of this
Agreement.  In addition, [***] with respect to the Relypsa Patent Rights at the
time of such acquisition.

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

17.4 Force Majeure.  Neither Party shall be liable or responsible to the other
Party for loss or damages, nor shall it have any right to terminate this
Agreement for any default or delay attributable to any event beyond its
reasonable control and without its fault or negligence, including but not
limited to acts of God, acts of government (including injunctions), fire, flood,
earthquake, strike, lockout, labor dispute, breakdown of plant, shortage of
critical equipment, loss or unavailability of manufacturing facilities or
material, casualty or accident, civil commotion, acts of public enemies, acts of
terrorism or threat of terrorist acts, blockage or embargo and the like (a
“Force Majeure Event”); provided, however, that in each such case the Party
affected shall use reasonable efforts to avoid such occurrence and to remedy it
promptly.  The Party affected shall give prompt notice of any such cause to the
other Party.  The Party giving such notice shall thereupon be excused from such
of its obligations hereunder as it is thereby disabled from performing for so
long as it is so disabled and for [***] ([***]) days thereafter, and the Party
receiving notice shall be similarly excused from its respective obligations
which it is thereby disabled from performing; provided, however, that such
affected Party commences and continues to take reasonable and diligent actions
to cure such cause.  Notwithstanding the foregoing, nothing in this Section 17.4
shall excuse or suspend the obligation to make any payment due hereunder in the
manner and at the time provided.

 

 

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17.5 Notices.  All notices or consents given under this Agreement will be in
writing, addressed to the Parties at the following addresses, and delivered by
person, by facsimile (with receipt confirmation), by email (with receipt
confirmation), or by FedEx or other reputable courier service.  Any such notice
will be deemed to have been given: (i) as of the day of personal delivery; (ii)
one (1) day after the date sent by confirmed facsimile or confirmed email; or
(iii) on the day of successful delivery to the other Party confirmed by the
courier service.  Unless otherwise specified in writing, the mailing addresses
of the Parties will 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 VFMCRP, addressed to:

Vifor Fresenius Medical Care Renal Pharma Ltd

Rechenstrasse 37

CH-9014 St. Gallen, Switzerland

Attn:  Chief Executive Officer

Facsimile:  +41 58 851 8001

Email:  [***]

 

With a copy to:

 

Vifor Fresenius Medical Care Renal Pharma Ltd

Rechenstrasse 37

CH-9014 St. Gallen, Switzerland

Attn:  General Counsel

Facsimile:  +41 58 851 8001

Email:  [***]

 

 

If to Relypsa, addressed to:

Relypsa, Inc.

100 Cardinal Way

Redwood City, CA 94063

Attn:  Chief Executive Officer

Facsimile:  [***]

Email:  [***]

Relypsa, Inc.

100 Cardinal Way

Redwood City, CA 94063

Attn:  General Counsel

Facsimile:  [***]

Email:  [***]

 

With copy to:

 

Judith Hasko and Mark Roeder

Latham & Watkins, LLP

140 Scott Drive

Menlo Park, CA 94025

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17.6 Amendment; Waivers.  No amendments or waivers of the terms and conditions
of this Agreement shall be binding upon either Party unless in writing, signed
by a duly authorized officer of that Party, and specifying the provision of this
Agreement that is amended or waived.  No waiver of any of the provisions of this
Agreement shall be deemed, or shall constitute, a waiver of any other provision,
whether or not similar, nor shall any waiver constitute a continuing waiver.

17.7 Counterparts.  This Agreement may be executed in two (2) or more
counterparts, each of which will be an original and all of which will constitute
together the same document.  Counterparts may be signed and delivered by
facsimile, or electronically in PDF format, each of which will be binding when
sent.

17.8 Construction.  Both Parties acknowledge and agree that: (a) they have
reviewed and negotiated the terms and provisions of this Agreement and have
contributed to its revision; (b) the rule of construction to the effect that any
ambiguities are resolved against the drafting Party shall not be employed in the
interpretation of this Agreement; and (c) the terms and provisions of this
Agreement shall be construed fairly as to both Parties hereto and not in a favor
of or against any Party.  Except where the context otherwise requires, wherever
used, the use of any gender will be applicable to all genders, and the word “or”
is used in the inclusive sense.  When used in this Agreement, “including” means
“including”.  References to either Party include the successors and permitted
assigns of that Party.  The headings of this Agreement are for convenience of
reference only and in no way define, describe, extend or limit the scope or
intent of this Agreement or the intent of any provision contained in this
Agreement.  If the terms of this Agreement conflict with the terms of any
Exhibit, then the terms of this Agreement will govern.  The official text of
this Agreement and any Exhibit hereto, any notice given or accounts or
statements required by this Agreement, and any dispute proceeding related to or
arising hereunder, will be in English.  In the event of any dispute concerning
the construction or meaning of this Agreement, reference will be made only to
this Agreement as written in English and not to any translation into any other
language.

17.9 Governing Law; Dispute Resolution.

(a) Governing Law.  Except as expressly provided in Section 10.1(a), this
Agreement shall be governed by and interpreted in accordance with the
substantive laws of New York, New York, USA, without regard to its or any other
jurisdiction’s choice of law rules that would result in the application of any
other substantive laws.

(b) Exclusive Dispute Resolution Mechanism.  If the Parties do not agree on a
matter arising out of, or in connection with, this Agreement (including matters
relating to any Party’s rights or obligations hereunder, or regarding the
construction, interpretation and enforceability of such rights or obligations),
the procedures set forth in Sections 17.9 and 17.10 (subject to Sections
17.10(g) and (h)) shall be the exclusive mechanism for resolving any dispute,
controversy, or claim (collectively, “Disputes”) between the Parties that may
arise from time to time that cannot be resolved through good faith negotiation
between the Parties.

(c) Resolution by Executives.  If any Dispute arise between the Parties in
connection with this Agreement, the construction hereof, or the rights, duties
or liabilities of either Party under this Agreement, except for those matters
for which [***] has the right to make the final decision pursuant to Section
3.1(e), the Parties shall first attempt in good faith to resolve such Dispute by
negotiation and consultation between themselves.  If such Dispute is not
resolved on an informal basis within [***] ([***]) days after a Party provides
written notice to the other Party of such Dispute, then either Party shall, by
written notice to the other Party, refer such Dispute for attempted resolution
by the Executives. If any Dispute is not resolved by such Executives within
[***] ([***]) days after it is referred to them, despite their good faith
efforts to resolve such Dispute, then except for matters to be decided [***]
pursuant to Section 3.1(e), each Party shall seek to resolve such Dispute
pursuant to Section 17.10.

 

 

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17.10 Arbitration.

(a) Arbitrators.  If any Dispute is unresolved pursuant to Section 17.9, such
Dispute shall be determined by arbitration administered by the International
Chamber of Commerce (“ICC”) in accordance with its International Arbitration
Rules (the “ICC Rules”).  In addition to the ICC Rules, the Parties agree that
the arbitration shall be conducted according to the IBA rules of evidence.

(b) Venue and Language. The place of arbitration shall be [***], and the
language to be used in any such proceeding (and for all testimony, evidence and
written documentation) shall be English.

(c) Arbitrators.  The arbitration will be conducted by a panel of [***], who
will be appointed as follows: [***].  Each arbitrator must have experience with
disputes involving the development and commercialization of pharmaceutical
products.

(d) Timing.  It is the intent of the Parties that, barring extraordinary
circumstances, the arbitration proceedings shall be concluded within one hundred
eighty (180) days from the commencement of the arbitration.  The Parties may
agree to extend this time limit, or the arbitrators may do so in their
discretion if it is determined that the interest of justice so requires. The
tribunal shall use its best efforts to issue the final award or awards within
such time period.  Failure to adhere to this time limit shall not be a basis for
challenging the award.

(e) Decision.  Without limiting any other remedies that may be available under
Applicable Law, the arbitrators shall have no authority to award punitive,
special, consequential, or any other similar form of damages.  Judgment upon any
award(s) rendered by the arbitrators may be entered in any court having
jurisdiction thereof.  Each Party hereby waives all objections which it may have
at any time to the laying of venue of any proceedings brought in such courts,
waives any claim that such proceedings have been brought in an inconvenient
forum and further waives the right to object with respect to such proceedings
that any such court does not have jurisdiction over such Party.

(f) Costs and Fees.  The arbitrators are authorized to include in the award an
allocation to either Party of such costs and expenses, including attorneys’
fees, as the arbitrators shall deem reasonable.  

(g) Preliminary Injunctions.  Notwithstanding anything in this Agreement to the
contrary, nothing in this Agreement shall prevent either Party from seeking
provisional measures from any court of competent jurisdiction to prevent
immediate and irreparable injury, loss, or damage on a provisional basis,
pending the decision of the arbitrators on the ultimate merits of any
Dispute.  Any such request shall not be deemed incompatible with the agreement
to arbitrate or a waiver of the right to arbitrate.

(h) Patent Disputes.  Notwithstanding anything in this Agreement to the
contrary, any and all issues regarding the validity and enforceability of any
patent in a country within the Licensed Territory (“Patent Matters”) shall be
determined in a court or other tribunal, as the case may be, of competent
jurisdiction under the applicable patent laws of such country.  If such Dispute
involves both Patent Matters and other matters, the arbitrators will have the
right to stay the arbitration until determination of Patent Matters material to
the resolution of the Dispute as to other matters is resolved.  

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(i) Confidentiality.  Except as may be required by Applicable Law, no Party (or
its representative, witnesses or arbitrators) may disclose the existence,
content or result of any arbitration under this Agreement without the prior
written consent of both Parties.  

17.11 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.

17.12 Compliance with Applicable Laws.

(a) General.  Each Party represents, warrants and covenants that it will comply
with all Applicable Laws, including, where applicable, then-current GLP, cGMP,
and then-current GCP, in performing its obligations and exercising its rights
hereunder, including the performance of activities connected with the
Development, manufacture, and Commercialization (as applicable) of Product under
this Agreement.

(b) Obligations.  Each of Relypsa and VFMCRP shall reasonably cooperate with the
other Party in its efforts to ensure that all government reporting, including
price and gift reporting, sales, marketing and promotional practices in respect
of each Product meet the standards required by Applicable Laws.  

(c) Information.  Each of Relypsa and VFMCRP shall reasonably cooperate with the
other Party to provide the other Party access to any and all information, data
and reports required by the other in order to enable the other Party to comply
with Applicable Laws, including reporting requirements, or the equivalent
thereof in the Licensed Territory, in a timely and appropriate manner.  Each
Party shall ensure that any such reporting is true, complete and correct in all
respects; provided however that neither Party shall be held responsible for
submitting erroneous reports to the extent such deficiencies result from
information provided by the other Party which itself was not true, complete and
correct.  

(d) Cooperation.  Relypsa and VFMCRP shall confer with each other on a regular
basis to discuss and compare their respective procedures and methodologies
relating to each Party’s compliance with Applicable Laws or fulfillment of any
other obligation in this Section 17.12.  In the event that the Parties have
different understandings or interpretations of this Section 17.12 or of the
applicability of, or standards required by any Applicable Laws, then the Parties
shall confer and seek to reach common agreement on such matters.

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(e) Prohibition of Corrupt Payments.   In connection with this Agreement, and
without limiting anything in this Section 17.12, each Party represents, warrants
and covenants that it has not given or promised to give, and will not make,
offer, agree to make or authorize any payment or transfer anything of value,
directly or indirectly, to (i) any Government or Public Official (as defined
below); (ii) any political party, party official or candidate for public or
political office; (iii) any person while knowing or having reason to know that
all or a portion of the value will be offered, given, or promised, directly or
indirectly, to anyone described in items (i) or (ii) above; or (iv) any owner,
director, employee, representative or agent of any actual or potential customer
of such Party (if any such transfer of value would be a violation of any
Applicable Laws). Each Party agrees to comply with all applicable anti-bribery
laws in the countries where the Parties have their principal places of business
and where they conduct activities under this Agreement.  Additionally, each
Party represents, warrants and covenants that such Party will shall comply with
the U.S. Foreign Corrupt Practices Act (“US FCPA”) and the UK Anti-Bribery Act,
both as revised from time to time, as well as similar Applicable Laws of the
country where a Party has its principal place of business and where such Party
conducts activities under this Agreement, and to take no action that would
reasonable be deemed to cause the other Party to be in violation of the US FCPA,
the UK Anti-Bribery Act or similar Applicable Laws of the country where a Party
has its principal place of business and where it conducts activities under this
Agreement. Additionally, each Party will make reasonable efforts to comply with
requests for information, including answering questionnaires and narrowly
tailored audit inquiries, to enable the other Party to ensure compliance with
applicable anti-bribery laws. For purposes of this Agreement, “Government or
Public Official” means any officer or employee or anyone acting in an official
capacity on behalf of: a government or any department or agency thereof; a
public international organization (such as the United Nations, the International
Monetary Fund, the International Red Cross, and the World Health Organization),
or any department, agency or institution thereof; or a government-owned or
controlled company, institution, or other entity, including a government-owned
hospital or university.

(f) Training. Each Party shall be responsible for training its personnel and
sales force as well as any other employee who is involved with the activities
set forth in the Agreement on anti-bribery practices at its own expense. Such
training shall include the provisions of the applicable anti- corruption
laws.  Upon request from VFMCRP, Relypsa shall promptly provide copy of the
training material and the training attendance sheets (including name and
qualification of the trainer).

17.13 Nothing in this Agreement shall be deemed to permit VFMCRP to export,
re-export or otherwise transfer any Information transferred hereunder or Product
manufactured therefrom without complying with Applicable Laws.

17.14 Entire Agreement.  This Agreement and the Exhibits attached hereto,
constitute and contain the complete, final and exclusive understanding and
agreement of the Parties, and cancel and supersede any and all prior and
contemporaneous negotiations, correspondence, understandings and agreements,
whether oral or written, between the Parties respecting the subject matter
hereof, including the Confidential Disclosure Agreement, and neither Party shall
be liable or bound to any other Party in any manner by any representations,
warranties, covenants, or agreements except as specifically set forth herein or
therein.  Nothing in this Agreement, express or implied, is intended to confer
upon any Party, other than the Parties and their respective successors and
assigns, any rights, remedies, obligations, or liabilities under or by reason of
this Agreement, except as expressly provided herein.

[Signature Page Follows]

 

 

51

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

 

IN WITNESS WHEREOF, the Parties have executed this Agreement by their duly
authorized officers as of the date below.  The date that this Agreement is
signed will not be construed to imply that the document was made effective on
that date.

 

VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA LTD

 

RELYPSA, INC.

 

 

 

 

 

 

 

By:

 

/s/ Christoph Springer

 

By:

 

/s/ John A. Orwin

 

 

 

 

 

 

 

Name:

 

Christoph Springer

 

Name:

 

John A. Orwin

 

 

 

 

 

 

 

Title:

 

Deputy Chief Executive Officer

 

Title:

 

President and Chief Executive Officer

 

 

 

 

 

 

 

Date:

 

 

 

Date:

 

 

 

By:

 

/s/ Oliver P. Kronenberg

 

 

 

Name:

 

Dr. Oliver P. Kronenberg

 

 

 

Title:

 

Group General Counsel

 

 

 

Date:

 

 

 

 

 

52

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

 

EXHIBIT 1.60

Product Trademarks

VELTASSA

 

 

 

 

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

 

EXHIBIT 1.83

VFMCRP TRADEMARKS

To be added after Effective Date

 

 

 

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

 

Exhibit 2.3

Countries/Distributors List Countries/Distributors List

[***]

 

 

 

[***] 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.

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

 

EXHIBIT 4.3

Development Plan

To be added after Effective Date.

 

 

 

[***] 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.

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

 

Exhibit 6.5.1

Trademark Style Guide

[***]

 

 

[***] 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.

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

 

[***]

 

 

[***] 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.

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

 

[***]

 

 

[***] 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.

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

 

[***]

 

 

[***] 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.

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

Exhibit 6.5.2

[***] Trademark Countries

[***]

 

 

[***] 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.

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

 

[***]

 

 

[***] 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.

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

EXHIBIT 8.2

MANUFACTURING AND SUPPLY TERMS

Binding Term Sheet for Patiromer

Manufacturing and Supply Agreement

 

Parties

Relypsa, Inc. (“Relypsa”)

Vifor Fresenius Medical Care Renal Pharma Ltd. (“VFMCRP”)

 

Definitions

Any defined terms used in this term sheet will have the meaning stated in this
term sheet, or, if not stated in this term sheet, the meaning provided in the
License Agreement (defined below).

 

Background

Relypsa and VFMCRP have entered into a license agreement under which VFMCRP has
agreed to develop and commercialize Relypsa’s product known as Patiromer in
certain countries (the “License Agreement”).

As agreed in the License Agreement, Relypsa and VFMCRP will negotiate and enter
into a definitive manufacturing and supply agreement (“MSA”) under which Relypsa
will, itself or through Third Party contractors, manufacture and supply to
VFMCRP Finished Product, [***] of Finished Product, subject to mutual agreement
of the Parties, in which case [***], on the terms set forth in this binding term
sheet.  During a mutually agreed time period following the effective date of the
MSA, the Parties will cooperate to [***] of Finished Product for the Licensed
Territory (which may include, without limitation, [***]).

 

Supply Commitment

To the extent permitted by applicable law, including, without limitation,
applicable antitrust laws, VFMCRP will order from Relypsa all of VFMCRP’s
forecasted requirements of Finished Product, [***] and Commercialization
purposes in the Licensed Territory.  Within a reasonable timeline, [***]

[***].

 

[***] 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.

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

Forecasting

At the beginning of [***], VFMCRP will give Relypsa a rolling forecast of
VFMCRP’s requirements for [***] for the following [***] ([***]) months.  Each
forecast will be broken down into a [***] delivery schedule.  In addition,
VFMCRP will provide a non-binding [***] forecast of its requirements for [***]
for the [***] once [***] and once [***] of each [***].  

The first [***] ([***]) months of the rolling forecast will represent firm
orders (“Firm Orders”).  Months [***] ([***]) through [***] ([***]) in the
forecast will be non-binding.  VFMCRP may request to vary the non-binding
portion of each forecast from the prior forecast provided by VFMCRP by plus or
minus (a) [***] percent (+/- [***]%) during months [***] ([***]) through [***]
([***]) and (b) [***] percent (+/- [***]%) during months [***] ([***]) through
[***] ([***]).  There would be [***]

during months [***] ([***]) through [***] ([***]). [***].

Relypsa will check the rolling forecast and will inform VFMCRP within [***] if
it has any concerns regarding whether such forecast complies with the
forecasting requirements in the MSA.

[***].

 

Ordering

VFMCRP will provide Relypsa with Firm Orders for Finished Product (or Drug
Substance, as applicable) according to the forecasted requirements and timing as
set forth in the committed portion of the rolling forecast.  VFMCRP may
[***].  In such case, Relypsa will [***] to honor those requests.

All Firm Orders will be in writing and will be confirmed by Relypsa in writing
at the latest [***] after receipt of each Firm Order.

[***].

[***]

 

Delivery; Risk of Loss

Deliveries of Finished Product (or Drug Substance, as applicable) will be made
under applicable mutually agreed terms .  Risk of loss of, or damage to, the
Finished Product (or Drug Substance, as applicable) will pass to VFMCRP in
accordance with such terms.  Title will pass to VFMCRP [***].

Relypsa will only supply Finished Product (or [***]) released for delivery by
Relypsa or its contract manufacturer in accordance with the procedure set forth
in the Quality Agreement (as defined below), including any required
documentation.

Each delivery will [***].

Transport conditions will be based upon the technical information for the
transportation attached to the MSA and the Firm Orders.

 

[***] 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.

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

Acceptance or Rejection

Within [***] upon delivery, VFMCRP will [***] inspect such batch for
transportation damages, losses and shortfalls ([***]).  VFMCRP will notify [***]
of any apparent defects, such as damaged containers or missing packages,
immediately upon arrival of the shipment and the freight documents at VFMCRP.  

VFMCRP will [***].

Following inspection as set forth in the second paragraph hereof, if the batch
delivered , or any portion thereof, does not conform to the requirements set
forth in the MSA or the Quality Agreement, VFMCRP will so notify Relypsa in
writing within [***] from receipt of the analytical test results, with such
notice specifying in reasonable detail the manner in which all or part of the
batch fails to meet the requirements thereunder.  If no written notice of such
non-conformity is sent to Relypsa by VFMCRP within such [***] period, such batch
will be conclusively and

irrevocably presumed to be inspected by VFMCRP and to conform to the
requirements of this MSA and the Quality Agreement.  If so requested by Relypsa,
VFMCRP will send to Relypsa a sample of the rejected shipment.

Any dispute between the Parties regarding the conformity or non-conformity of
the batch will be resolved by an independent expert to be agreed upon by the
Parties.  The decision of such expert will be binding on both Parties, with the
fees of the expert to be borne either by Relypsa (if the concerned shipment does
not comply) or by VFMCRP (if the concerned shipment does comply).  

At Relypsa’s discretion, any batches delivered to VFMCRP that do not conform
will either be returned to Relypsa with freight and insurance charges to be
[***] or destroyed by VFMCRP, [***].  In such later case VFMCRP will
provide  Relypsa with evidence of the destruction.

If delivered batch does not conform to such requirements, Relypsa will use
commercially reasonable efforts to supply replacement batch as soon [***] that
is in conformity therewith.

 

Pricing

Relypsa will deliver [***] and Finished Product to VFMCRP at a price equal to
[***].  

[***].

VFMCRP will have the right to audit, not more than [***] during each [***] and
during regular business hours, the financial records maintained by Relypsa to
determine the accuracy of the supply price charged to VFMCRP under the
Agreement.  

 

Payment

Relypsa will invoice VFMCRP for each delivery.  Payment is due [***] after the
date of invoice, by bank transfer in US dollars.  [***].

 

Term and Termination

The MSA will continue in effect until the expiration or earlier termination of
the License Agreement.  Upon expiry or termination of the MSA, [***].

 

Quality Agreement

As provided in Section 8.2 of the License Agreement, the Parties will enter into
a quality agreement governing all quality related aspects in regard to the MSA,
including without limitation the ability to [***], and other quality assurance
and quality control matters (the “Quality Agreement”).  The MSA will contain
terms to govern other audits related to the manufacture of Finished Product (or
Drug Substance, as applicable).

 

[***]

[***].

 

[***] 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.

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

Governing Law

The MSA will be governed by the law of New York, USA, without regard to its or
any other jurisdiction’s choice of law rules that will result in the application
of any

other substantive laws.

 

Other Terms

The MSA will contain other reasonable and customary terms and conditions, to be
negotiated by the Parties, including without limitation arbitration,
representations and warranties, liability limits, termination, indemnification,
and confidentiality.

 

 

 

[***] 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.

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

Exhibit 11.1(k)

[***]

 

 

[***] 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.

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

EXHIBIT 11.2

RELYPSA PATENT RIGHTS

[***]

 

 

[***] 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.

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

 

[***]

 

 

[***] 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.

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

 

[***]

 

 

[***] 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.

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

 

[***]

 

 

[***] 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.

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

 

[***]

 

 

[***] 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.

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

 

[***]

 

 

[***] 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.

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

 

[***]

 

 

[***] 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.

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

 

[***]

 

 

[***] 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.

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

 

[***]

 

 

[***] 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.

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

 

[***]

 

 

[***] 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.

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

 

[***]

 

 

[***] 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.

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

 

[***]

 

 

[***] 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.

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

 

[***]

 

 

[***] 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.

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

 

[***]

 

 

[***] 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.

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

 

[***]

 

 

 

[***] 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.

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

EXHIBIT 14.6

Press Release

[g201511042055229411491.jpg]

[g201511042055229411492.jpg]

NEWS RELEASE

 

Relypsa Contact:

VFMCRP Contact:

Charlotte Arnold

Beatrix Benz

Vice President, Corporate Communications

Head of Global Communications & Public Affairs

650.421.9352

+41 58 851 80 00

IR@relypsa.com

beatrix.benz@viforpharma.com

RELYPSA AND VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA ENTER INTO PARTNERSHIP TO
COMMERCIALIZE PATIROMER FOS IN EUROPE AND ADDITIONAL TERRITORIES

-Patiromer FOS to be Commercialized by the Largest Dedicated Renal and Heart
Failure Sales Forces in Europe, If Approved    -

REDWOOD CITY, CA and ST. GALLEN, SWITZERLAND, August 10, 2015 (GLOBE NEWSWIRE) –
Relypsa, Inc. (NASDAQ:RLYP), a biopharmaceutical company, and Vifor Fresenius
Medical Care Renal Pharma Ltd. (VFMCRP), a common company of Galenica and
Fresenius Medical Care, today announced they have entered into an exclusive
partnership to commercialize Patiromer for Oral Suspension (Patiromer FOS),
Relypsa’s investigational medicine for the treatment of hyperkalemia.

Under the terms of the agreement, Relypsa will receive an upfront cash payment
of $40 million and will be eligible to receive payments of up to $125 million
upon achieving certain regulatory and sales based milestones. In addition,
Relypsa will receive tiered double-digit royalties on net sales of Patiromer FOS
in the licensed territories. VFMCRP will obtain an exclusive marketing right
from Relypsa in worldwide territories except the United States and Japan, where
Relypsa retains all commercial rights. Relypsa and VFMCRP will collaborate on
ongoing development of Patiromer FOS, including submission of a Marketing
Authorization Application (MAA) with the European Medicines Agency (EMA).

Patiromer FOS is an oral potassium binder being developed for the treatment of
hyperkalemia, a potentially life-threatening condition defined as abnormally
elevated levels of potassium in the blood. Hyperkalemia occurs most frequently
in patients with chronic kidney disease (CKD) and heart failure. A New Drug
Application (NDA) for Patiromer FOS for the treatment of hyperkalemia is under
review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug
User Fee Act (PDUFA) date of October 21, 2015. A Marketing Authorization
Application (MAA) for Patiromer FOS is expected to be submitted with the EMA in
the first half of 2016.

“We are excited to partner with VFMCRP which has a well-established commercial
organization with a proven track record in cardiorenal diseases” said John A.
Orwin, president and chief executive officer of Relypsa. “We

 

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

are confident Vifor Fresenius Medical Care Renal Pharma will be an excellent
partner to commercialize and develop Patiromer FOS outside the United States and
look forward to working with them to bring this medicine to patients around the
world.”

“Patiromer FOS has the potential to become an important new treatment option for
hyperkalemia. We are pleased about partnering with Relypsa to bring this
exciting medicine to patients in Europe and other markets as soon as possible,”
said Stefan Schulze, CEO, Vifor Fresenius Medical Care Renal Pharma. “The
agreement with Relypsa is a recognition of VFMCRP’s growing leadership in
nephrology as we continue to expand our renal pharma product portfolio and
commercial organization.”

Conference Call Today at 5:00 EM 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), participant 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 CKD, and/or heart failure, as
well as patients with diabetes and hypertension. The clinical program includes a
two part pivotal Phase 3 program conducted under Special Protocol Assessment
with the 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
serious condition that 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 being developed for the treatment of hyperkalemia, 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 until 2030 in the United States and
2029 in the European Union. More information is available at www.relypsa.com.

About Vifor Fresenius Medical Care Renal Pharma Ltd.

Vifor Fresenius Medical Care Renal Pharma Ltd., a common company of Galenica and
Fresenius Medical Care, develops and commercializes innovative and high quality
therapies to improve the life of patients suffering from chronic kidney disease
worldwide. The company was founded at the end of 2010 and is owned 55 percent by
Galenica and 45 percent by Fresenius Medical Care.

 

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

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 approval and
launch of Patiromer for Oral Suspension, or Patiromer FOS, the experience and
capabilities of Vifor Fresenius Medical Care Renal Pharma Ltd., or VFMCRP, the
expected impact of Relypsa’s partnership with VFMCRP, the therapeutic and
commercial potential of Patiromer FOS 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.

 

CONTACT:

 

Relypsa Cotact:

 

 

 

 

 

Charlotte Arnold

 

 

 

 

 

Vice President, Corporate Communications

 

 

 

 

 

650.421.9352

 

 

 

 

 

IR@relypsa.com

 

 

 

VFMCRP Contact:

 

 

 

 

 

Beatrix Benz

 

 

 

 

 

Head of Global Communications & Public Affairs

 

 

 

 

 

+41 58 851 80 16

 

 

 

 

 

communications@viforpharma.com

[g201511042055240031493.jpg]

Source: Relypsa, Inc.

News Provided by Acquire Media